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MS213500 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: More than 1 million Americans per year have acute myocardial infa rct ion ( 1 ) . Those who survive to hospital discharge have a 5 % to 10 % risk for dying suddenly within the first year ( 27 ) . Prevention of those sudden deaths is an important goal , and several approaches have been used to accomplish it . Secondary prevention with type I antiarrhythmic drugs has been unsuccessful ( 8) . Prophylactic use of amiodarone has significantly reduced death after myocardial infa rct ion in some but not all r and omized trials . Quantitative overviews of these studies suggest that amiodarone reduces mortality rates by 10 % to 20 % ( 9 , 10 ) . Recent studies of the implantable cardioverter defibrillator ( ICD ) in patients who have no history of sustained arrhythmia have also had mixed results , with positive results in patients with unsustained ventricular tachycardia ( 11 , 12 ) and negative results in patients with reduced ejection fraction and positive results on signal-averaged electrocardiography ( 13 ) . The use of prophylactic ICD has nevertheless attracted great interest because of the demonstrated efficacy of the device in patients who have had a documented episode of ventricular fibrillation or sustained ventricular tachycardia ( 1416 ) . Although ongoing or planned r and omized , controlled trials ( 17 , 18 ) will clarify the role of ICDs and amiodarone therapy in patients who have had myocardial infa rct ions , the results of these trials will not be available until late 2001 at the earliest . We previously showed that ICDs can be cost-effective in patients who have survived an episode of ventricular fibrillation or sustained ventricular tachycardia ( 19 ) . These findings can not be extrapolated to prophylactic use of ICDs in patients who have had myocardial infa rct ions because the risk for sudden death in such patients is lower . Indeed , the current st and ard of care for patients who have had myocardial infa rct ion does not include prophylactic antiarrhythmic therapy . With recent evidence of the efficacy of antiarrhythmia management in patients who have had myocardial infa rct ions , the potential cost-effectiveness of prophylactic antiarrhythmic therapy should be reassessed . In this study , we estimated survival and costs for patients with past myocardial infa rct ion who were treated with amiodarone , ICD , or no specific antiarrhythmic therapy . We evaluated the level of efficacy needed to make prophylactic therapy with an ICD or amiodarone cost-effective in three groups of patients with past myocardial infa rct ion who were stratified by left ventricular ejection fraction . Methods We used a decision model to estimate the length of life and expenditures for patients who had myocardial infa rct ion without symptomatic , sustained ventricular arrhythmia and who received one of three treatment strategies : ICD , amiodarone therapy , or no antiarrhythmic therapy ( Figure 1 ) . We stratified patients into three groups according to ejection fraction : less than or equal to 0.3 , 0.31 to 0.4 , and greater than 0.4 . Although the ability of many clinical factors to predict the risk for sudden cardiac death has been analyzed and several independent risk factors have been identified ( 20 ) , ejection fraction has consistently been the single most powerful predictor of sudden cardiac death ( 2124 ) . Figure 1 . The decision model . The square node on the left represents a choice among three alternative treatments : implantable cardiac defibrillator ( ICD ) , amiodarone , and no antiarrhythmic treatment . Circles represent chance nodes . Patients who receive an ICD are at risk for death from the implant procedure . Patients who do not die of ICD implantation and patients who are receiving amiodarone or no treatment enter the Markov tree ( denoted by rectangles containing circles and an arrow ) . The Markov tree represents the clinical events that can occur during each 1-month period as a patient is followed until death . During each 1-month period , a patient may die from arrhythmic or nonarrhythmic cardiac causes and may also die of noncardiac causes . If none of these events occur , the patient remains well for the 1-month period . Patients who have an ICD may have a lead infection or failure that causes them to withdraw from treatment ( and to switch to no antiarrhythmic therapy ) . Patients who receive amiodarone are at risk for amiodarone toxicity . In our analysis , a patient may die of toxicity , withdraw from treatment ( and switch to no antiarrhythmic therapy ) , or have acute toxicity that does not require discontinuation . We adhered to the recommendations of the Panel on Cost-effectiveness in Health and Medicine ( 25 , 26 ) . We used a societal perspective to evaluate health benefits and costs , discounting each at a rate of 3 % per year . We performed one-way sensitivity analyses on all of the model variables , as well as selected two-way , three-way , and n-way ( Monte Carlo ) probabilistic sensitivity analyses ( 27 ) . Decision Model We developed a Markov model ( 28 , 29 ) ( SMLTree decision analysis software , version 2.9 , J. Hollenberg , New York , New York ) by modifying a model used previously to assess the cost-effectiveness of ICDs or amiodarone in patients who had experienced sustained ventricular arrhythmia ( 19 , 30 ) ( Figure 1 ) . Our current model includes the possibility of no antiarrhythmic therapy and uses data relevant to the lower-risk population of patients who have survived myocardial infa rct ion . The model tracks a cohort of patients who received prophylactic ICD ( implanted without a thoracotomy ) , amiodarone therapy , or no antiarrhythmic therapy . Patients who received an ICD were at risk for procedural death . Patients who survived ICD implantation , patients treated with amiodarone , and patients who received no antiarrhythmic therapy entered a Markov tree ( Figure 1 ) . Each month , these patients were at risk for sudden cardiac death , nonsudden cardiac death , and noncardiac death . We assumed that 2 % of the ICD-treated patients would have the ICD removed because of infection or lead complications during the first year and that 1 % of surviving patients would withdraw from ICD therapy in each subsequent year ( 3133 ) . Similarly , we assumed that 10 % of the amiodarone-treated patients would withdraw from therapy because of toxicity during the first year and that 5 % of surviving patients would withdraw in each subsequent year ( 3445 ) . Because the use of antiarrhythmic therapy in the postmyocardial infa rct ion population would be prophylactic , we assumed that crossovers between the ICD and amiodarone strategies would be less likely . Therefore , patients who withdrew from one antiarrhythmic treatment would be withdrawn from prophylactic treatment . Patient Sample Our base-case analyses evaluated the cost-effectiveness of each antiarrhythmic management strategy in three cohorts of patients defined by ejection fraction ( Table 1 ) . We obtained mortality and inpatient cost data for patients from the Myocardial Infa rct ion Triage and Intervention ( MITI ) patient registry ( 46 ) who had had myocardial infa rct ion . Between 1988 and 1994 , approximately 40 000 patients were admitted to cardiac care units in 19 hospitals in Seattle , Washington . Hospitals participating in the registry include 2 university hospitals , 2 staff-model health maintenance organization hospitals , 1 Veterans Affairs hospital , and 14 community hospitals . During most of the study period , 10 of the participating hospitals had on-site catheterization laboratories and 5 performed bypass surgery . During the study period , 12 000 patients presented with an acute myocardial infa rct ion ; of these , ejection fraction was measured in approximately 3000 . Table 1 . Clinical Characteristics of the Myocardial Infa rct ion Triage and Intervention Patient Sample Patients with ejection fractions of 0.3 or less had a mean age ( SD ) of 66.5 11.92 years ( range , 26 to 95 years ) , 24.6 % 43.1 % had a history of congestive heart failure , 62.8 % 48.4 % received an initial catheterization , and 26.6 % 44.3 % underwent initial revascularization . Patients with ejection fractions between 0.31 and 0.4 had a mean age of 63.5 12.22 years ( range , 36 to 97 years ) , 11.0 % 31.3 % had a history of congestive heart failure , 73.2 % 44.3 % underwent catheterization , and 37.6 % 48.4 % had revascularization . Finally , patients with ejection fractions greater than 0.4 had a mean age of 61.5 11.83 years ( range , 26 to 92 years ) , 3.5 % 18.4 % had a history of congestive heart failure , 88.0 % 32.4 % received an initial catheterization , and 48.0 % 50 % underwent revascularization . We compared the characteristics of patients who had ejection fraction measurements with those of patients in the MITI registry for whom ejection fraction was not measured . The clinical characteristics listed in Table 1 differed significantly between these groups , but the rates of sudden cardiac , nonsudden cardiac , noncardiac , and overall mortality did not differ significantly after we controlled for age , sex , and cardiac history ( 24 ) . From the MITI registry , we obtained monthly probabilities of cardiac death for the three ejection fraction cohorts . The MITI project used hospital discharge summaries and death certificates to identify patients who died of cardiac causes during follow-up while in or out of the hospital ( 47 ) . We classified cardiac deaths that occurred in neither a hospital nor a nursing home as sudden and potentially preventable by arrhythmic therapy ; we classified as nonsudden the cardiac deaths that occurred in a hospital or a nursing home . We recognized the limitations of this classification system and therefore analyzed a range of ICD efficacies . Table 1 summarizes the probabilities of sudden and nonsudden cardiac death for the three cohorts over time . To estimate life expectancy after the end of follow-up in the MITI cohort , we extrapolated the annual cardiac mortality rate for subsequent years from that observed during follow-up and assumed that the noncardiac mortality rate would equal that in the general U.S. population ( 48 ) . Effectiveness of Background —The implantable cardioverter-defibrillator ( ICD ) is an effective but expensive device . We used prospect ively collected data from a large r and omized clinical trial of secondary prevention of life-threatening ventricular arrhythmias to determine the cost-effectiveness of the ICD compared with antiarrhythmic drug ( AAD ) therapy , largely with amiodarone . Methods and Results —Charges for initial and repeat hospitalizations , emergency room , and day surgery stays and the costs of antiarrhythmic drugs were collected on 1008 patients . Detailed records of all other medical encounters and expenses were collected on a subgroup of 237 patients . Regression models were then created to attribute these expenses to the rest of the patients . Charges were converted to 1997 costs using st and ard methods . Costs and life years were discounted at 3 % per year . Three-year survival data from the Antiarrhythmics Versus Implantable Defibrillators trail were used to calculate the base-case cost-effectiveness ( C/E ) ratio . Six-year , twenty-year , and lifetime C/E ratios were also estimated . At 3 years , total costs were $ 71 421 for a patient taking AADs and $ 85 522 for a patient using an ICD , and the ICD provided a 0.21-year survival benefit over AAD treatment . The base-case C/E ratio was thus $ 66 677 per year of life saved by the ICD compared with AAD therapy ( 95 % CI , $ 30 761 to $ 154 768 ) . Six- and 20-year C/E ratios remained stable between $ 68 000 and $ 80 000 per year of life saved . Conclusions —The ICD is moderately cost-effective for secondary prevention of life-threatening ventricular arrhythmias , as judged from prospect ively collected data in a r and omized clinical trial Background —In the Canadian Implantable Defibrillator Study ( CIDS ) , we assessed the cost-effectiveness of the implantable cardioverter-defibrillator ( ICD ) in reducing the risk of death in survivors of previous ventricular tachycardia ( VT ) or fibrillation ( VF ) . Methods and Results —Healthcare re source use was collected prospect ively on the first 430 patients enrolled in CIDS ( n=212 ICD , n=218 amiodarone ) . Mean cost per patient , adjusted for censoring , was computed for each group based on initial therapy assignment . Incremental cost-effectiveness of ICD therapy was computed as the ratio of the difference in cost ( ICD minus amiodarone ) to the difference in life expectancy ( both discounted at 3 % per year ) . All costs are in 1999 Canadian dollars ( C$ 1 ≈ US$ 0.65 ) . Over 6.3 years , mean cost per patient in the ICD group was C$ 87 715 versus C$ 38 600 in the amiodarone group ( difference C$ 49 115 ; 95 % CI C$ 25 50
Output:
| For secondary prevention , the results showed that the ICD is considered cost-effective in patients with more risk .
For primary prevention , the cost-effectiveness of ICD has been widely studied , but uncertainty about its cost-effectiveness remains .
The cost-effectiveness ratios vary between studies depending on the patient characteristics , methodology , perspective , and national setting s. Among the European studies , the conclusions are varied , where the ICD is considered cost-effective or not dependent on the study |
MS213501 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background There is controversial evidence regarding whether foot orthoses or knee braces improve pain and function or correct malalignment in selected patients with osteoarthritis ( OA ) of the medial knee compartment . However , insoles are safe and less costly than knee bracing if they relieve pain or improve function . Questions / purpose sWe therefore asked whether laterally wedged insoles or valgus braces would reduce pain , enhance functional scores , and correct varus malalignment comparable to knee braces . Patients and Methods We prospect ively enrolled 91 patients with symptomatic medial compartmental knee OA and r and omized to treatment with either a 10-mm laterally wedged insole ( index group , n = 45 ) or a valgus brace ( control group , n = 46 ) . All patients were assessed at 6 months . The primary outcome measure was pain severity as measured on a visual analog scale . Secondary outcome measures were knee function score using WOMAC and correction of varus alignment on AP whole-leg radiographs taken with the patient in the st and ing position . Additionally , we compared the percentage of responders according to the OMERACT-OARSI criteria for both groups . Results We observed no differences in pain or WOMAC scores between the two groups . Neither device achieved correction of knee varus malalignment in the frontal plane . According to the OMERACT-OARSI criteria , 17 % of our patients responded to the allocated intervention . Patients in the insole group complied better with their intervention . Although subgroup analysis results should be translated into practice cautiously , we observed a slightly higher percentage of responders for the insole compared with bracing for patients with mild medial OA . Conclusions Our data suggest a laterally wedged insole may be an alternative to valgus bracing for noninvasively treating symptoms of medial knee OA.Level of Evidence Level I , therapeutic study . See the Guidelines for Authors for a complete description of level of evidence OBJECTIVE To investigate the clinical efficacy of the Generation II ( G II ) knee brace , a newly developed knee orthosis , on patients experiencing severe medial compartment osteoarthritis ( OA ) of the knee . DESIGN Case series . SETTING A national medical and pharmaceutical hospital in Japan . PATIENTS Twenty primary OA subjects ( excluding those with secondary OA ) , all older than 55 years of age and experiencing only knee joint problems , were selected according to their ability to walk more than 500 meters independent of support . These patients had arthritis in both knees and no less than one half of normal joint space remaining as revealed by roentgenogram studies . The more severely affected side was selected for bracing . INTERVENTIONS For 12 months , each patient wore a G II knee brace on the affected knee on a daily basis , removing it only at night . To evaluate the effects of G II OA brace alone , additional use of new oral drugs or any other treatment was prohibited from 1 month before application of the G II OA brace and throughout the trial period . MAIN OUTCOME MEASURES Clinical efficacy was evaluated using the Japan Orthopaedic Association 's knee scoring system . X-ray evaluation was performed with patients st and ing on one leg . A dynamometer was used to evaluate isokinetic quadriceps muscle strength . The center of gravity was measured using an X-Y recording . Clinical evaluation was performed every 2 months thereafter . Final evaluation was at 12 months . RESULTS Nineteen of the 20 patients answered that they experienced significant pain relief . Knee pain scores on walking increased from 18.0 to 21.5 and on ascending and descending stairs increased from 12.8 to 15.8 . The femorotibial angle decreased in 12 of the patients , and the mean angle decreased from 185.1 degrees before application to 183.7 degrees with the brace on at the final observation period . In addition , isokinetic quadriceps muscle strength increased from an average of 36.8 Nm to 42.8 Nm for all patients . In 17 patients , quadriceps muscle strength increased , while it decreased in 2 and remained the same in 1 . Finally , lateral movement of the center of gravity decreased compared with before G II application in all patients . CONCLUSION G II bracing is a beneficial treatment for severe medial OA of the knee OBJECTIVE To assess the radiographic and symptomatic effects of treating patients with medial compartment osteoarthritis ( OA ) of the knee with laterally wedged insoles with subtalar strapping of varying elevations . DESIGN Prospect i ve quasi-experimental evaluation . SETTING Outpatient clinic in Japan . PARTICIPANTS Sixty-two women out patients with knee OA who were r and omized into 3 groups according to their birth date s and wedge elevation . INTERVENTIONS Participants wore laterally wedged insoles with subtalar strapping with elevations of 8 , 12 , or 16 mm for 2 weeks . MAIN OUTCOME MEASURES St and ing radiographs were used to analyze the femorotibial angle for each subject , both with and without their respective unilateral insoles . The remission scores of the Lequesne index of severity for knee OA were compared among the 3 groups at the conclusion . Participants were asked to report adverse effects on use of the insoles . RESULTS The 16-mm group ( n=21 ) showed a significantly greater valgus correction of the femorotibial angle than the 8-mm group ( n=20 ) ( P=.013 ) . The remission score was significantly improved in the 12-mm group ( n=21 ) compared with the 16-mm group ( P=.029 ) . Adverse effects were more common in the 16-mm group ( 9/21 , 42.8 % ) than in the 12-mm ( 3/21 , 14.3 % ) or 8-mm ( 2/20 , 10 % ) groups . CONCLUSIONS The degree of change in femorotibial angle with the insole with subtalar strapping was affected by the tilt of the lateral wedge . For constant routine use , the 8- or 12-mm elevation wedged insoles with subtalar strapping may be more comfortable and effective than the 16-mm elevation wedge PURPOSE The purpose s of this study were to assess a ) the effectiveness of Masai Barefoot Technology ( MBT ) shoe in reducing knee pain in persons with knee osteoarthritis ( OA ) and ( b ) changes in balance , ankle and knee ROM , and ankle strength compared with a high-end walking shoe for 12 wk . METHODS The research design was a r and omized controlled trial ( 123 subjects , knee OA ) . Subjects were r and omized to a MBT ( N = 57 ) or a control shoe ( N = 66 ) . A Western Ontario and McMaster Universities ( WOMAC ) OA index , BMI , balance , active ROM , and ankle torque were quantified at week 0 , 3 , 6 , 9 , and 12 . Two- sample t-tests were done for between-group comparisons . RESULTS There was no significant difference between groups in total pain score . A significant reduction over the 12-wk period was found for both shoe conditions ( -42/500 or 25.6 % MBT , -46.2 or 27.1 % control ) . There was no significant group difference in pain during walking ( t = -1.09 , P = 0.28 ) . Pain during walking was significantly reduced by 5.2/100 mm in the MBT and 9.7/100 mm in the control group . Total pain showed a significant reduction for the MBT -27.4/500 ( -16.6 % ) and the control group -28.9/500 ( -17.0 % ) between baseline and week 3 . Between week 3 and 6 , there was a significant reduction for the MBT group only ( -27.2/500 or -20.0 % ) . There was a significant increase in the static balance between baseline and 12 wk in the MBT group only , although the difference between groups was not significant . DISCUSSION The results indicate that special shoe interventions can reduce pain in subjects with moderate knee OA We examined if a subject-specific amount of lateral wedge added to a foot orthosis could alter knee mechanics to potentially reduce the progression of knee osteoarthritis in patients with medial knee osteoarthritis . Twenty individuals with medial knee osteoarthritis ( > /=2 Kellgren Lawrence grade ) were prescribed a custom laterally wedged foot orthotic device . The prescribed wedge amount was the minimal wedge amount that provided the maximum amount of pain reduction during a lateral step-down test . Following an accommodation period , all subjects returned to the laboratory for a gait analysis . Knee mechanics were collected as the subjects walked at an intentional walking speed . Walking in the laterally wedged orthotic device significantly reduced the peak adduction moment during early stance ( p < 0.01 ) compared to the nonwedged device . Similarly , the wedged orthotic device significantly reduced the knee adduction excursion from heel strike to peak adduction ( p < 0.01 ) compared to the nonwedged device . No differences in the peak adduction moment during propulsion or peak adduction during stance were observed between the orthotic conditions . A subject-specific laterally wedged orthotic device was able to reduce the peak knee adduction moment during early stance , which is thought to be associated with the progression of knee osteoarthritis . Previous studies on this device have reported issues associated with foot discomfort when using wedge amounts > 7 degrees ; however , no such issues were reported in this study . Therefore , providing a custom laterally wedged orthotic device may potentially increase compliance while still potentially reducing disease progression Objective This study aim ed to determine whether the effect of laterally wedged insoles on the adduction moment in knee osteoarthritis ( OA ) declined after one month of wear , and whether higher reported use of insoles was associated with a reduced effect on the adduction moment at one month . Methods Twenty people with medial compartment OA underwent gait analysis in their own shoes wearing i ) no insoles and ; ii ) insoles wedged laterally 5 ° in r and om order . Testing occurred at baseline and after one month of use of the insoles . Participants recorded daily use of insoles in a log-book . Outcomes were the first and second peak external knee adduction moment and the adduction angular impulse , compared across conditions and time with repeated measures general linear models . Correlations were obtained between total insole use and change in gait parameters with used insoles at one month , and change scores were compared between high and low users of insoles using general linear models . Results There was a significant main effect for condition , whereby insoles significantly reduced the adduction moment ( all p < 0.001 ) . However there was no significant main effect for time , nor was an interaction effect evident . No significant associations were observed between total insole use and change in gait parameters with used insoles at one month , nor was there a difference in effectiveness of insoles between high and low users of the insoles at this time . Conclusion Effects of laterally wedged insoles on the adduction moment do not appear to decline after one month of continuous use , suggesting that significant wedge degradation does not occur over the short-term OBJECTIVE To assess the effect of an insole with subtalar strapping on patients with medial compartment osteoarthritis ( OA ) of the knee . METHODS Novel lateral wedged insoles with elastic subtalar strapping ( the subtalar strapping support group ) and ankle supporters with a lateral wedged heel insert ( the sock-type ankle support group ) were prepared . Eighty-eight female out patients with knee OA were treated with 1 of the 2 insoles for 8 weeks . Femorotibial angle was assessed by st and ing radiographs with and without unilateral insole use for each subject . Symptoms of knee OA were evaluated according to the severity index of Lequesne et al at baseline and at the final assessment . RESULTS Participants wearing the insole with subtalar strapping ( n = 42 ) demonstrated significantly decreased femorotibial angle ( an average of change : -3.1 degrees + /- 2.5 degrees , P < 0.0001 ) , but a significant difference was not found in the sock-type ankle support group ( n = 46 ; -0.4 degrees + /- 1.1 degrees , P > 0.05 ) . In the subtalar strapping support group , pain during bed rest with full extension of the knee ( P < 0.0001 ) , pain after getting up ( P = 0.04 ) , pain on getting up from a seated position ( P = 0.021 ) , maximum distance walked ( P = 0.009 ) , and aggregate severity score ( P < 0.0001 ) were significantly improved compared with baseline . In contrast , significant symptomatic improvement was detected only in the aggregate score ( P = 0.016 ) in the sock-type ankle support group , but not in any of the 10 specific categories . CONCLUSION The lateral wedged insole with subtalar strapping induces correction of the femorotibial angle and symptomatic relief in patients with varus-deformity knee OA OBJECTIVES The goals of the study were to measure the force applied to the lateral side of the knee by a valgus loading brace design ed for patients with medial compartment osteoarthritis ( OA ) and to compare the varus moment at the knee during level gait with and without the brace . METHODS Five subjects diagnosed with medial compartment OA were fitted with a custom Monarch valgus loading knee brace . A 3-dimensional videobased motion analysis system and force plate information were used to calculate forces and moments at the knee . An instrumented condylar bladder was used to determine the force applied to the knee by the brace . The varus moments for the braced and unbraced
Output:
| Results suggest that knee braces and foot orthoses are effective in decreasing pain , joint stiffness , and drug dosage .
They also improve proprioception , balance , Kellgren/Lawrence grading , and physical function scores in subjects with varus and valgus knee osteoarthritis .
Knee braces and foot orthoses could be cautiously considered as conservative management for relief of pain and stiffness and improving physical function for persons with knee osteoarthritis . |
MS213502 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: One hundred sixteen consecutive patients entered a functional restoration treatment program for chronic low back pain and were compared with 72 patients not treated . A two-year follow-up survey reached more than 85 % of both groups ; its findings were compared with earlier results of a five-month and one-year follow-up . Analysis demonstrated that 87 % of the treatment group was actively working after two years , as compared with only 41 % of the nontreatment comparison group . Moreover , about twice as many of the comparison group patients had additional spine surgery relative to the treatment group . The comparison group continued with an approximately five times higher rate of patient visits to health professionals in the second year as the treatment group . Also , treatment group reinjury rates were no higher than those expected in the general population , while nontreatment subjects had a higher incidence of reinjury . Finally , a small treatment " dropout " group did poorest of all , with results in almost all areas even worse than those of the comparison group patients Study Design . A r and omized controlled trial with a 6-month follow-up period was conducted . Objective . To compare lumbar extension exercise and whole-body vibration exercise for chronic lower back pain . Summary of Background Data . Chronic lower back pain involves muscular as well as connective and neural systems . Different types of physiotherapy are applied for its treatment . Industrial vibration is regarded as a risk factor . Recently , vibration exercise has been developed as a new type of physiotherapy . It is thought to activate muscles via reflexes . Methods . In this study , 60 patients with chronic lower back pain devoid of “ specific ” spine diseases , who had a mean age of 51.7 years and a pain history of 13.1 years , practice d either isodynamic lumbar extension or vibration exercise for 3 months . Outcome measures were lumbar extension torque , pain sensation ( visual analog scale ) , and pain-related disability ( pain disability index ) . Results . A significant and comparable reduction in pain sensation and pain-related disability was observed in both groups . Lumbar extension torque increased significantly in the vibration exercise group ( 30.1 Nm/kg ) , but significantly more in the lumbar extension group ( + 59.2 Nm/kg ; SEM 10.2;P < 0.05 ) . No correlation was found between gain in lumbar torque and pain relief or pain-related disability ( P > 0.2 ) . Conclusions . The current data indicate that poor lumbar muscle force probably is not the exclusive cause of chronic lower back pain . Different types of exercise therapy tend to yield comparable results . Interestingly , well-controlled vibration may be the cure rather than the cause of lower back pain OBJECTIVE Recent evidence suggests that fibromyalgia is a disorder characterized by dysfunctional brain activity . Because transcranial direct current stimulation ( tDCS ) can modulate brain activity noninvasively and can decrease pain in patients with refractory central pain , we hypothesized that tDCS treatment would result in pain relief in patients with fibromyalgia . METHODS Thirty-two patients were r and omized to receive sham stimulation or real tDCS with the anode centered over the primary motor cortex ( M1 ) or the dorsolateral prefrontal cortex ( DLPFC ) ( 2 mA for 20 minutes on 5 consecutive days ) . A blinded evaluator rated the patient 's pain , using the visual analog scale for pain , the clinician 's global impression , the patient 's global assessment , and the number of tender points . Other symptoms of fibromyalgia were evaluated using the Fibromyalgia Impact Question naire and the Short Form 36 Health Survey . Safety was assessed with a battery of neuropsychological tests . To assess potential confounders , we measured mood and anxiety changes throughout the trial . RESULTS Anodal tDCS of the primary motor cortex induced significantly greater pain improvement compared with sham stimulation and stimulation of the DLPFC ( P < 0.0001 ) . Although this effect decreased after treatment ended , it was still significant after 3 weeks of followup ( P = 0.004 ) . A small positive impact on quality of life was observed among patients who received anodal M1 stimulation . This treatment was associated with a few mild adverse events , but the frequency of these events in the active-treatment groups was similar to that in the sham group . Cognitive changes were similar in all 3 treatment groups . CONCLUSION Our findings provide initial evidence of a beneficial effect of tDCS in fibromyalgia , thus encouraging further trials & NA ; Complex regional pain syndrome type 1 ( CRPS1 ) involves cortical abnormalities similar to those observed in phantom pain and after stroke . In those groups , treatment is aim ed at activation of cortical networks that subserve the affected limb , for example mirror therapy . However , mirror therapy is not effective for chronic CRPS1 , possibly because movement of the limb evokes intolerable pain . It was hypothesised that preceding mirror therapy with activation of cortical networks without limb movement would reduce pain and swelling in patients with chronic CRPS1 . Thirteen chronic CRPS1 patients were r and omly allocated to a motor imagery program ( MIP ) or to ongoing management . The MIP consisted of two weeks each of a h and laterality recognition task , imagined h and movements and mirror therapy . After 12 weeks , the control group was crossed‐over to MIP . There was a main effect of treatment group ( F(1,11)=57 , P<0.01 ) and an effect size of ∼25 points on the Neuropathic pain scale . The number needed to treat for a 50 % reduction in NPS score was ∼2 . The effect of treatment was replicated in the crossed‐over control subjects . The results uphold the hypothesis that a MIP initially not involving limb movement is effective for CRPS1 and support the involvement of cortical abnormalities in the development of this disorder . Although the mechanisms of effect of the MIP are not clear , possible explanations are sequential activation of cortical pre‐motor and motor networks , or sustained and focussed attention on the affected limb , or both & NA ; In complex regional pain syndrome ( CRPS1 ) initiated by wrist fracture , a motor imagery program ( MIP ) , consisting of h and laterality recognition followed by imagined movements and then mirror movements , reduces pain and disability , but the mechanism of effect is unclear . Possibilities include sustained attention to the affected limb , in which case the order of MIP components would not alter the effect , and sequential activation of cortical motor networks , in which case it would . Twenty subjects with chronic CRPS1 initiated by wrist fracture and who satisfied stringent inclusion criteria , were r and omly allocated to one of three groups : h and laterality recognition , imagined movements , mirror movements ( RecImMir , MIP ) ; imagined movements , recognition , imagined movements ( ImRecIm ) ; recognition , mirror movements , recognition ( RecMirRec ) . At 6 and 18 weeks , reduced pain and disability were greater for the RecImMir group than for the other groups ( P<0.05 ) . H and laterality recognition imparted a consistent reduction in pain and disability across groups , however , this effect was limited in magnitude . Imagined movements imparted a further reduction in pain and disability , but only if they followed h and laterality recognition . Mirror movements also imparted a reduction in pain and disability , but only when they followed imagined movements . The effect of the MIP seems to be dependent on the order of components , which suggests that it is not due to sustained attention to the affected limb , but is consistent with sequential activation of cortical motor networks OBJECTIVES We have previously reported in two r and omized controlled trials that cognitive intervention and exercises more effectively improved isokinetic trunk muscle strength than lumbar fusion and postoperative rehabilitation in patients with chronic low back pain . The aim of the present study was to predict changes in muscle strength as regard to changes in pain , function , fear-avoidance beliefs ( self-rated question naires ) , changes in cross-sectional area and density of the back muscles and treatment . METHODS We assessed 1 ) isokinetic trunk muscle strength ; 2 ) cross-sectional area and density of back muscles by computer-tomography ( CT ) ; and 3 ) pain , function , fear-avoidance beliefs , and self- efficacy for pain in the included patients at baseline and 1-year follow-up . Multiple regression analysis was performed with change in muscle strength as dependent variables , and changes in area/density and self-rated symptoms and treatment as independent variables . RESULTS The correlations between the change in muscle strength and change in both cross-sectional area and density were weak ( r < 0.1 ) and nonsignificant and these variables were not included in the multiple regression analysis . The change in pain , change in fear-avoidance beliefs , change in self-efficacy for pain and treatment explained 46 % of the change in muscle strength , with change in pain and treatment as significant predictors . CONCLUSION Our results emphasize the central role of pain and treatment for the improvements in muscle strength in patients with chronic low back pain Abstract Practice guidelines recommend various types of exercise and manipulative therapy for chronic back pain but there have been few head‐to‐head comparisons of these interventions . We conducted a r and omized controlled trial to compare effects of general exercise , motor control exercise and manipulative therapy on function and perceived effect of intervention in patients with chronic back pain . Two hundred and forty adults with non‐specific low back pain ⩾3 months were allocated to groups that received 8 weeks of general exercise , motor control exercise or spinal manipulative therapy . General exercise included strengthening , stretching and aerobic exercises . Motor control exercise involved retraining specific trunk muscles using ultrasound feedback . Spinal manipulative therapy included joint mobilization and manipulation . Primary outcomes were patient‐specific function ( PSFS , 3–30 ) and global perceived effect ( GPE , −5 to 5 ) at 8 weeks . These outcomes were also measured at 6 and 12 months . Follow‐up was 93 % at 8 weeks and 88 % at 6 and 12 months . The motor control exercise group had slightly better outcomes than the general exercise group at 8 weeks ( between‐group difference : PSFS 2.9 , 95 % CI : 0.9–4.8 ; GPE 1.7 , 95 % CI : 0.9–2.4 ) , as did the spinal manipulative therapy group ( PSFS 2.3 , 95 % CI : 0.4–4.2 ; GPE 1.2 , 95 % CI : 0.4–2.0 ) . The groups had similar outcomes at 6 and 12 months . Motor control exercise and spinal manipulative therapy produce slightly better short‐term function and perceptions of effect than general exercise , but not better medium or long‐term effects , in patients with chronic non‐specific back pain Many manual therapists assess and treat spinal stiffness of people with low back pain . The objectives of this study were to investigate : ( i ) whether spinal stiffness changes after treatment ; ( ii ) the relationship between pre-treatment spinal stiffness and change in stiffness with treatment ; ( iii ) the relationship between spinal stiffness , pain , disability and global perceived effect of treatment ; ( iv ) whether spinal stiffness predicts outcome of treatment or response to treatment in chronic low back pain patients . One hundred and ninety-one subjects with chronic low back pain were r and omly allocated to groups that received either spinal manipulative therapy , motor control exercise , or a general exercise program . Spinal stiffness was assessed before and after intervention . All three groups showed a significant decrease in stiffness following treatment ( p<0.001 ) . No difference between groups was observed . There was a significant negative correlation between pre-treatment stiffness and change in stiffness ( r=-0.61 ; p<0.001 ) . There was a significant but weak correlation ( r=0.18 ; p=0.02 ) between change in stiffness and change in global perceived effect of treatment , and a significant but weak correlation between change in stiffness and change in function for subjects in the spinal manipulative therapy group ( r=-0.28 ; p=0.02 ) . No significant association was observed between initial stiffness score and any of the final outcome measures following treatment . Initial stiffness did not predict response to any treatment . In conclusion , spinal stiffness decreases over the course of an episode of treatment , more so in those with the stiffest spines , but the decrease is not dependent on treatment and is not generally related to outcome Design . R and omized prospect i ve study of the effects of three types of active therapy on back muscle function in chronic low back pain patients . Objectives . To quantify the effects of 3 months active therapy on strength , endurance , activation , and fatigability of the back entensor muscles . Summary of Background Data . Many studies have documented an association between chronic low back pain and diminished muscular performance capacity . Few studies have quantified the changes in these measures following interventions using objective measurement techniques or related them to changes in clinical outcome . Methods . A total of 148 individuals ( 57 % women ) with chronic low back pain ( age , 45.0 ± 10.0 years ; duration of low back pain , 10.9 ± 9.5 years ) were r and omized to a treatment that they attended for 3 months : active physiotherapy , muscle reconditioning on devices , or low-impact aerobics . Before and after therapy , assessment s were made of the following : trunk muscle strength ( in flexion , extension , lateral bending , and axial rotation ) , erector spinae activation ( maximal , and during forward bending movements ) , back extensor endurance ( Biering-S/orensen test ) , and erector spinae fatigability ( determined from changes in the median frequency of the surface electromyographic signal ) during isometric and dynamic tests . Results . A total of 132 of 148 patients ( 89 % ) completed the therapy . Isometric strength in each movement direction increased in all groups post-therapy ( P < 0.0008 ) , most notably in the devices group . Activation of the erector spinae during the extension tests also increased significantly in all groups and showed a weak , but significant , relationship with increased maximal strength ( P = 0.01 ) . Pretherapy 55 % of the subjects showed no relaxation of the back muscles at L5 when in the fully flexed position ; no changes were observed in any group post-therapy . Endurance time during
Output:
| Conclusions The findings do not support the notion that the treatment effects of exercise therapy in cLBP are directly attributable to changes in the musculoskeletal system . |
MS213503 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background Fatigue or lack of interest can reduce the feasibility of intensive physical exercise in nursing home residents . Low-volume exercise interventions with similar training effects might be an alternative . The aim of this r and omised controlled trial was to investigate the feasibility of Whole Body Vibration ( WBV ) in institutionalised elderly , and its impact on functional capacity and muscle performance . Methods Twenty-four nursing home residents ( 15 female , 9 male ; mean age 77.5 ± 11.0 years ) were r and omised ( stratification for age , gender and ADL-category ) to 6 weeks static WBV exercise ( WBV+ , N = 13 ) or control ( only static exercise ; N = 11 ) . Outcome measures were exercise compliance , timed up- and -go , Tinetti-test , back scratch , chair sit- and -reach , h and grip strength and linear isokinetic leg extension . Results At baseline , WBV+ and control groups were similar for all outcome variables . Twenty-one participants completed the program and attended respectively 96 % and 86 % of the exercise sessions for the WBV+ and control groups . Training-induced changes in timed up- and -go and Tinetti-test were better for WBV+ compared to control ( p = 0.029 for timed up- and -go , p = 0.001 and p = 0.002 for Tinetti body balance and total score respectively ) . In an alternative analysis ( Worst Rank Score & Last Observation Carried Forward ) the differences in change remained significant on the Tinetti body balance and total score . No other significant differences in change between both groups were observed . Conclusion In nursing home residents with limited functional dependency , six weeks static WBV exercise is feasible , and is beneficial for balance and mobility . The supplementary benefit of WBV on muscle performance compared to classic exercise remains to be explored further OBJECTIVE To use two different exercise programs over a 2-year period to reduce falls and their sequelae among residents of two long-term care facilities . DESIGN R and omized , controlled trial . SETTING The study took place at two long-term care facilities with services ranging from independent living to skilled nursing . PARTICIPANTS One hundred and ten participants whose average age was 84 and who were capable of ambulating with or without assistive devices and could follow simple directions . INTERVENTION Participants were r and omized to one of two exercise groups ( resistance/endurance plus basic enhanced programming or tai chi plus basic enhanced programming ) or to a control group ( basic enhanced programming only ) . Exercise classes were held three times per week throughout the study . MEASUREMENTS Participants were evaluated for cognitive and physical functioning at baseline and 6 , 12 , and 24 months . Falls were determined from incident reports filed by the nursing staffs at the facilities . RESULTS Time to first fall , time to death , number of days hospitalized , and incidence of falls did not differ among the treatment and control groups ( P>.05 ) . Among all participants , those who fell had significantly lower baseline Folstein Mini-Mental State Examination and instrumental activities of daily living scores and experienced significantly greater declines in these measures over the 2-year program . CONCLUSION There were no significant differences in falls among the two exercise groups and the control group . Lack of treatment differences and low adherence rates suggest that residents of long-term care facilities may require individualized exercise interventions that can be adapted to their changing needs This paper describes a quasi-experimental study of a musical exercise intervention to improve the physical , cognitive , behavioral status and life satisfaction of older residents in a long-term care facility in the United Kingdom . Twenty long-term care residents from three different units ( n=60 ) were recruited and assigned to one of three groups : a control ( C ) group ( no intervention ) , an occupational therapy ( OT ) group ( comparison group ) and a music exercise group ( intervention group ) . Assessment s of physical and cognitive status were made pre-intervention and repeated at the end of the 10-week exercise program and again 10 weeks after the completion of the program . The results show that both OT and exercise participation is associated with improvement in physical and cognitive function . However , the exercise group showed significant improvement in more areas than the OT group . The functional benefits from OT and exercise were not sustainable after these activities ceased and showed significant decline 10 weeks after the end of the programs OBJECTIVES To establish the effectiveness of a fall-prevention program in reducing falls and injurious falls in older residential care residents . DESIGN Cluster , r and omized , controlled trial . SETTING Fourteen r and omly selected residential care homes in Auckl and , New Zeal and . PARTICIPANTS All older residents ( n=628 , 95 % participation rate ) . INTERVENTION Residential care staff , using existing re sources , implemented systematic individualized fall-risk management for all residents using a fall-risk assessment tool , high-risk logo , and strategies to address identified risks . MEASUREMENTS Number of residents sustaining a fall , falls , and injurious-falls incidence rates . RESULTS During 12 months of follow-up , 103 ( 43 % ) residents in the control group and 173 ( 56 % ) residents in the intervention group fell ( P<.018 ) . There was a significantly higher incidence rate of falls in intervention homes than in control homes ( incident rate ratio=1.34 , 95 % confidence interval=1.06 - 1.72 ) during the intervention period after adjusting for dependency level ( type of home ) , baseline fall rate , and clustering . There was no difference in the injurious fall incidence rate or incidence of serious injuries . CONCLUSION This fall-prevention intervention did not reduce falls or injury from falls . Low-intensity intervention may be worse than usual care OBJECTIVE to determine the effect of risk factor modification and balance exercise on falls rates in residential care homes . DESIGN cluster r and omised controlled trial . PARTICIPANTS 196 residents ( aged 60 years or over ) in 20 residential care homes were enrolled ( 38 % response rate ) . Homes were r and omly allocated to intervention and control arms . A total of 102 residents were consigned to the intervention arm and 94 to the control arm . INTERVENTION a multifactorial falls prevention programme including 3 months gait and balance training , medication review , podiatry and optometry . MAIN OUTCOME MEASURES number of falls/recurrent falls per person , number of medications per person , and change in Tinetti gait and balance measure . RESULTS in the intervention group there was a mean of 2.2 falls per resident per year compared with 4.0 in the control group ; this failed to reach statistical significance ( P = 0.2 ) once the intra-cluster correlation ( ICC , 0.10 ) had been accounted for . Several risk factors were reduced in the intervention arm . CONCLUSIONS falls risk factor reduction is possible in residents of care homes . A modest reduction in falls rates was demonstrated but this failed to reach statistical significance Many studies have documented the effectiveness of verbally elicited imagery in the enhancement of motor skills in young , nondisabled population s. The present study examined the effects of verbally elicited imagery in the encouragement of two exercises ( i.e. , reaching up to pick apples and reaching down to pick up coins ) in elderly women . The subjects were 27 women between 62 and 96 years of age who were selected from a nursing home , a residential retirement home , and a foster care home . All of the subjects received imagery as well as control conditions , but in a counterbalanced fashion . The Wilcoxon matched-pairs signed rank tests indicated that the imagery condition elicited significantly more repetitions of the reaching-up exercise than did the control condition ( z = 2.25 , p [ one-tailed ] = .012 ) . The results in the reaching-down exercise were generally in the same direction but difficult to interpret statistically . The results are discussed in terms of other recent research investigating ways to add purpose to therapeutic exercise through occupation . Clinicians are urged to explore the advantages and disadvantages of imagery-based occupations in treatment The aims of this r and omised controlled trial were to determine if a high-intensity functional exercise program improves balance , gait ability , and lower-limb strength in older persons dependent in activities of daily living and if an intake of protein-enriched energy supplement immediately after the exercises increases the effects of the training . One hundred and ninety-one older persons dependent in activities of daily living , living in residential care facilities , and with a Mini-Mental State Examination ( MMSE ) score of ? 10 participated . They were r and omised to a high-intensity functional exercise program or a control activity , which included 29 sessions over 3 months , as well as to protein-enriched energy supplement or placebo . Berg Balance Scale , self-paced and maximum gait speed , and one-repetition maximum in lower-limb strength were followed-up at three and six months and analysed by 2 x 2 factorial ANCOVA , using the intention-to-treat principle . At three months , the exercise group had improved significantly in self-paced gait speed compared with the control group ( mean difference 0.04 m/s , p = 0.02 ) . At six months , there were significant improvements favouring the exercise group for Berg Balance Scale ( 1.9 points , p = 0.05 ) , self-paced gait speed ( 0.05 m/s , p = 0.009 ) , and lower-limb strength ( 10.8 kg , p = 0.03 ) . No interaction effects were seen between the exercise and nutrition interventions . In conclusion , a high-intensity functional exercise program has positive long-term effects in balance , gait ability , and lower-limb strength for older persons dependent in activities of daily living . An intake of protein-enriched energy supplement immediately after the exercises does not appear to increase the effects of the training OBJECTIVES To evaluate the effectiveness of a multifaceted , nonpharmaceutical intervention on incidence of falls and fallers . DESIGN Prospect i ve , cluster-r and omized , controlled 12-month trial . SETTING Six community nursing homes in Germany . PARTICIPANTS Long-stay residents ( n = 981 ) aged 60 and older ; mean age 85 ; 79 % female . INTERVENTIONS Staff and resident education on fall prevention , advice on environmental adaptations , progressive balance and resistance training , and hip protectors . MEASUREMENTS Falls , fallers , and fractures . RESULTS The incidence density rate of falls per 1,000 resident years ( RY ) was 2,558 for the control group ( CG ) and 1,399 for the intervention group ( IG ) ( relative risk ( RR ) = 0.55 , 95 % confidence interval ( CI ) = 0.41 - 0.73 ) . Two hundred forty-seven ( 52.3 % ) fallers were detected in the CG and 188 ( 36.9 % ) in the IG ( RR = 0.75 , 95 % CI = 0.57 - 0.98 ) . The incidence density rate of frequent fallers ( > 2/year ) was 115 ( 24.4 % ) for the CG and 66 ( 13.0 % ) for the IG ( RR = 0.56 , 95 % CI = 0.35 - 0.89 ) . The incidence density rate of hip fractures per 1,000 RY was 39 for the CG and 43 for the IG ( RR = 1.11 , 95 % CI = 0.49 - 2.51 ) . Other fractures were diagnosed with an incidence density rate of 52 per 1,000 RY for CG and 41 per 1,000 RY for IG ( RR = 0.78 , 95 % CI = 0.57 - 1.07 ) . CONCLUSION The incidence density rate of falls and fallers differed considerably between the control and intervention groups . The study was underpowered to demonstrate a significant difference of hip or nonhip fractures . Because of a low fracture rate in both groups , the investigation of fracture rates would have required a larger sample size to detect an effect of the intervention Abstract A r and omised controlled trial was undertaken to measure effects of exercise on : 1 . Progression of cognitive symptoms related to dementia using the Clock-Drawing Test ( Shulman et al. 1993 ) ; and 2 . Disability using the Revised Elderly Persons Disabilities Scale ( REPDS ; Fleming and Bowles 1993 ) . Data was analysed from 75 nursing home residents with dementia who were r and omly assigned to one experimental group and two control groups . Group 1 ( control ) received no intervention . Group 2 ( control ) received a social visit equivalent in duration and frequency as those undertaking the exercise program in the experimental group , Group 3 . A specifically design ed , frail aged appropriate , twelve-week exercise program was undertaken by the those in the experimental group three times per week . Each session lasted for 30 minutes . Findings from the : 1 . Clock-drawing test showed that exercise may slow the rate of progression of the cognitive symptoms related to dementia ; and 2 . REPDS showed that exercise slowed and reversed disability in some of the activities of daily living One of the effects of Alzheimer 's disease is a diminution in the ability to communicate . A r and omized , non-blinded two-group experimental study was undertaken to determine if planned walking has the capacity to improve the communication performance of patients with moderate to severe Alzheimer 's disease . Thirty subjects meeting NINCDS-ADRDA diagnostic criteria for probable Alzheimer 's disease , selected from two nursing homes , participated in the study . Intervention and comparison groups were each made up of subjects from both nursing homes . Subjects in one group were walked individually for 30 minutes three times a week for 10 weeks . Subjects in the comparison group were engaged in conversation for the same amount of time for 10 weeks . A multivariate analysis of variance ( MANOVA ) was performed on the communication data .
Output:
| Provision of physical rehabilitation interventions to long-term care residents is worthwhile and safe , reducing disability with few adverse events .
Most trials reported improvement in physical condition .
However , there is insufficient evidence to make recommendations about the best intervention , improvement sustainability and cost-effectiveness |
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Input: Abstract Objective : To evaluate an experimental heroin maintenance programme . Design : R and omised trial . Setting : Outpatient clinic in Geneva , Switzerl and . Subjects : Heroin addicts recruited from the community who were socially marginalised and in poor health and had failed in at least two previous drug treatments . Intervention : Patients in the experimental programme ( n=27 ) received intravenous heroin and other health and psychosocial services . Control patients ( n=24 ) received any other conventional drug treatment ( usually methadone maintenance ) . Main outcome measures : Self reported drug use , health status ( SF-36 ) , and social functioning . Results : 25 experimental patients completed 6 months in the programme , receiving a median of 480 mg of heroin daily . One experimental subject and 10 control subjects still used street heroin daily at follow up ( difference 44 % ; 95 % confidence interval 16 % to 71 % ) . Health status scores that improved significantly more in experimental subjects were mental health ( 0.58 SD ; 0.07 to 1.10 ) , role limitations due to emotional problems ( 0.95 SD ; 0.11 to 1.79 ) , and social functioning ( 0.65 SD ; 0.03 to 1.26 ) . Experimental subjects also significantly reduced their illegal income and drug expenses and committed fewer drug and property related offences . There were no benefits in terms of work , housing situation , somatic health status , and use of other drugs . Unexpectedly , only nine ( 38 % ) control subjects entered the heroin maintenance programme at follow up . Conclusions : A heroin maintenance programme is a feasible and clinical ly effective treatment for heroin users who fail in conventional drug treatment programmes . Even in this population , however , another attempt at methadone maintenance may be successful and help the patient to stop using injectable opioids INTRODUCTION Numerous investigations have shown that premature discharge against medical advice from alcohol detoxification treatment is associated with poor outcome . The aim of the present study was to assess the risk of different possible influencing factors . PATIENTS AND METHOD 168 in- patients admitted for detoxification treatment were included in the study . All patients were detoxified using clome-thiazole and /or carbamazepine in individual , symptom-triggered dosages . Possible influencing factors were recorded using a st and ardised interview . RESULTS Cox regression revealed a lower risk of premature discharge being significantly asso-ciated with few preceding withdrawals , intoxication at admission and treatment with clomethiazole . Kaplan-Meier survival statistics showed a significantly lower risk only for being treated with clomethiazole ( premature discharge until day 7 : chi2=25.07 ; p<0.001 ; premature discharge until day 14 : chi2=5.19 ; p=0.023 ) . Other included demographic factors like daily intake of ethanol before admission , duration of alcohol dependence , age or smoking status were not associated with the risk of premature discharge . DISCUSSION The present findings show that pharmacotherapy with clomethiazole may positively influence the risk of premature discharge . This might be a consequence of the psychoactive properties of the drug which leads to positive reinforcement Because of a controversial view on the role of smoking in the recovery process of alcoholism , outcome data obtained for alcoholics who had been included in a long-term clinical trial with a putative anticraving drug were analyzed . To avoid unknown interactions between the drug under study and smoking behavior , only placebo-treated patients were evaluated in this investigation . After 12 months of rehabilitation , there was no significant difference regarding abstinence rate between 48 smoking alcoholics ( who reported that they smoked 32 cigarettes on average per day ) and 15 nonsmoking alcoholics ( 33 % vs. 20 % ) . However , smokers tended to be abstinent longer than nonsmokers ( 173 vs. 114 days ; P= .092 ) . This possible advantage might be related to nicotinic effects on central dopamine systems in smokers , as indicated by higher growth hormone secretion after apomorphine stimulation obtained in smokers , compared with findings for nonsmokers ( area under the curve during chronic intoxication : 2253 vs. 1247 microg/min/l ; P= .019 ) . Multivariate regression analysis revealed a decreasing effect of ethanol blood level ( P= .006 ) and the number of fullfilled International Classification of Diseases , 10th edition ( ICD-10 ) criteria of the alcohol dependence syndrome ( P= .012 ) on stimulated growth hormone secretion . In contrast , the reported number of smoked cigarettes per day had an increasing effect ( P= .034 ) , accounting for 6 % of the variance of growth hormone secretion . However , differences in outcome could also be explained by other clinical features as smokers , compared with nonsmokers , were more frequently males ( 78.3 % vs. 60.7 % ) and younger when studied at index episode ( mean age 44.45 vs. 48.21 years ; P= .054 ) , reported higher ethanol consumption in the month before hospital admission ( 262 g vs. 192 g ; P= .044 ) , and met more criteria for the ICD-10 alcohol dependence syndrome ( 6.6 vs. 6.0 ; P= .047 ) . Therefore , it can not be stringently inferred from our data that a possible advantage of smoking for alcoholism recovery is causally related to the effects of nicotine on cerebral systems or human behavior , as our findings had not been based on a r and omized design Background : To investigate the improvement in quality of life ( QoL ) of alcohol-dependent patients during a 3-week inpatient withdrawal programme , and to identify the sociodemographic , clinical and alcohol-related variables associated with baseline QoL on admission and with improvement of QoL during residential treatment . Methods : This prospect i ve , observational study included 414 alcohol-dependent patients , hospitalised for a period of 3 weeks . QoL was measured on admission and at discharge using the French version of the Medical Outcome Study SF-36 . The mean scores for each dimension and for the Physical and Mental Component Summary scores were calculated . Results : The mean scores per dimension and the mean Physical and Mental Component Summary scores were significantly lower on admission than at discharge ; the lowest scores being observed for social functioning and role limitations due to emotional problems . At discharge , the mean scores per dimension were similar to those observed in the French general population . Female gender , age > 45 years , living alone , working as a labourer or employee , somatic comorbidity , and the existence of at least five criteria for alcohol dependence according to the DSM-IV classification were associated with a low Physical Component Summary score on admission ; psychiatric comorbidity , the presence of at least five DSM-IV dependence criteria , smoking and suicidality were associated with a low Mental Component Summary score on admission . The increase in Physical and Mental Component Summary scores during hospitalisation was more marked when the initial scores were low . Apart from the initial score , the greatest improvement in Physical Component Summary score was seen in patients with a high alcohol intake and in those without a somatic comorbidity ; the increase in Mental Component Summary score was greatest in patients without psychotic symptoms and in those who abused or were dependent on illegal drugs . Conclusion : QoL improvement after a residential treatment was related to low QoL scores at admission . Improvement in physical component of QoL was related to baseline alcohol intake and good somatic status . Improvement in mental component of QoL was related to other drugs abuse/dependence This study examined the association between stopping smoking at 1 year after substance use treatment intake and long-term substance use outcomes . Nine years of prospect i ve data from 1185 adults ( 39 % female ) in substance use treatment at a private health care setting were analyzed by multivariate logistic generalized estimating equation models . At 1 year , 14.1 % of 716 participants who smoked cigarettes at intake reported stopping smoking , and 10.7 % of the 469 non-smokers at intake reported smoking . After adjusting for sociodemographics , substance use severity and diagnosis at intake , length of stay in treatment , and substance use status at 1 year , those who stopped smoking at 1 year were more likely to be past-year abstinent from drugs , or in past-year remission of drugs and alcohol combined , at follow-ups than those who continued to smoke ( OR=2.4 , 95 % CI : 1.2 - 4.7 and OR=1.6 , 95 % CI : 1.1 - 2.4 , respectively ) . Stopping smoking at 1 year also predicted past-year alcohol abstinence through 9 years after intake among those with drug-only dependence ( OR=2.4 , 95 % CI : 1.2 - 4.5 ) . We found no association between past-year alcohol abstinence and change in smoking status at 1 year for those with alcohol dependence or other substance use diagnoses when controlling for alcohol use status at 1 year . Stopping smoking during the first year after substance use treatment intake predicted better long-term substance use outcomes through 9 years after intake . Findings support promoting smoking cessation among smoking clients in substance use treatment Smoking is highly prevalent ( 85%-98 % ) in methadone maintenance treatment ( MMT ) patients . Methadone has been shown to increase cigarette smoking in a dose-dependent manner , whereas smoking/nicotine has been shown to increase methadone self-administration and reinforcing properties . The objective of this study was to evaluate methadone-nicotine interactions in MMT patients during trough and peak methadone effect conditions . Subjective effects of nicotine ( administered by cigarette smoking , 4 mg of nicotine gum and placebo gum ) and methadone and their combination were assessed in 40 regularly smoking , stabilized MMT patients using a r and omized , placebo-controlled , within-subject study design . Subjects responded to a battery of subjective assessment s before and after nicotine administration both before methadone administration ( cycles 1 and 2 ) and 3 hours after methadone administration ( cycles 3 and 4 ) . There was a main effect of methadone on the decrease of opioid withdrawal scores ( P < 0.001 ) , and cigarette smoking enhanced this effect ( day × methadone interaction , P = 0.031 ) . Both nicotine and methadone had main effects on the decrease of nicotine withdrawal scores ( P < 0.001 and P = 0.001 , respectively ) ; this was associated with the cigarette day ( day × nicotine interaction , P = 0.003 , and day × methadone interaction , P = 0.004 ) . Nicotine plasma levels were highest on the cigarette smoking day ( P < 0.001 ) . Methadone and nicotine shared main effects on the increase of ratings of euphoria and drug liking and on the decrease of restlessness , irritability , and depression . The overall results may help to explain high smoking rates in the MMT population and may account for reports of increased positive effects of methadone when the drugs are taken together BACKGROUND A r and omised controlled trial of substance misuse indicated that many patients who use methadone have respiratory symptoms and /or are prescribed respiratory medications . There is little research in this area . AIMS To determine the prevalence of respiratory disease and prescriptions among drug misusers . METHODS This historical cohort study of drug misusers and matched controls analysed routinely collected primary care data . The prevalence of common chronic respiratory diseases , class and number of respiratory medications were examined . RESULTS The cohort of 18,570 patients ( 9,285 per group ) was mostly male ( 64 % , n=11,890 ) and aged 31 - 59 years ( 76 % , n=14,060 ) . After adjusting for age , gender , deprivation and smoking status , the results showed that more drug misusers than controls had a diagnosis of asthma or chronic obstructive pulmonary disease ( 17.1 % vs. 10.9 % ; adjusted odds ratio ( OR ) 1.61 , 95 % confidence interval ( CI ) 1.46 to 1.77 , and 2.4 % vs. 0.8 % ; OR 1.86 , 95 % CI 1.42 to 2.44 , respectively ) and were prescribed more chronic respiratory medications : short-acting β(2)-agonists ( 16.4 % vs. 7.9 % ; OR 2.00 , 95 % CI 1.80 to 2.22 ) , long-acting β(2)-agonists ( 1 % vs. 0.4 % ; OR 1.93 , 95 % CI 1.29 to 2.89 ) , and inhaled corticosteroids ( 10.6 % vs. 7.6 % ; OR 1.49 , 95 % CI 1.33 to 1.67 ) . All differences were statistically significant ( p<0.001 ) . CONCLUSIONS Drug misusers have a significantly higher prevalence of respiratory diseases and respiratory prescriptions than matched controls . Further work is needed to determine the reasons for this The frequencies of structural chromosomal aberrations were analyzed in peripheral blood lymphocytes of 31 chronic alcoholics at the beginning of an intensive outpatient treatment program at a neuropsychiatric clinic and were compared with 31 controls matched for gender , age , smoking habits , and nondrinkers . A statistically significant difference was observed in the level of chromosomal aberrations in
Output:
| Smoking rates among people in addiction treatment are more than double those of people with similar demographic characteristics .
Smoking rates are also higher in people being treated for opiate dependence compared with people being treated for alcohol use disorder |
MS213505 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: CONTEXT Illness and hospitalization often trigger functional decline among older persons . Home care services implemented for functional decline provide an opportunity to intervene to improve outcomes . OBJECTIVE To compare functional status and the likelihood of remaining at home for persons receiving restorative care vs usual home care . DESIGN AND SETTING Intervention using prospect i ve individual matching conducted between November 1 , 1998 , and April 30 , 2000 . Six offices of a home care agency in Connecticut were used . One branch office served as the restorative care unit and the other 5 served as usual care offices . PARTICIPANTS Patients receiving home care through the restorative care office who were 65 years or older ; in receipt of Medicare-covered home care lasting at least 7 days ; with absence of severe cognitive impairment ; and not terminal , bedridden , or requiring total care were matched with patients from 1 of the usual care offices . The matching factors included age , sex , race , baseline self-care function , cognitive status , whether hospitalization preceded the home care episode , and date of the home care episode . Of the 712 eligible restorative care patients , 691 ( 97 % ) were matched with a usual care patient . INTERVENTION Restorative care , provided by the home care agency nursing , therapy , and home health aide staff , was based on principles from geriatric medicine , nursing , rehabilitation , and goal attainment . MAIN OUTCOME MEASURES Remaining at home , functional status at completion of the home care episode , and duration and intensity of home care episode . RESULTS Compared with usual care , and after adjusting for baseline characteristics and other factors , restorative care was associated with a greater likelihood of remaining at home ( 82 % vs 71 % ; odds ratio [ OR ] , 1.99 ; 95 % confidence interval [ CI ] , 1.47 - 2.69 ) and a reduced likelihood of visiting an emergency department ( 10 % vs 20 % ; OR , 0.44 ; 95 % CI , 0.32 - 0.61 ) . Home care episodes were shorter ( mean [ SD ] , 24.8 [ 26.8 ] days vs 34.3 [ 44.2 ] days ; S = -17 821 ; P<.001 ) . Restorative care patients had better mean ( SD ) scores than usual care patients in self-care ( 11.0 [ 2.1 ] vs 10.7 [ 2.5 ] ; P = .07 after adjustment ) , home management ( 9.5 [ 2.9 ] vs 9.2 [ 3.0 ] ; P = .05 after adjustment ) , and mobility ( 3.3 [ 0.8 ] vs 3.2 [ 0.9 ] ; P = .02 after adjustment ) . CONCLUSIONS This trial suggests that reorganizing the structure and goals of home care can enhance health outcomes of older patients without increasing health care utilization Objective To assess the effectiveness of an activity programme in improving function , quality of life , and falls in older people in residential care . Design Cluster r and omised controlled trial with one year follow-up . Setting 41 low level dependency residential care homes in New Zeal and . Participants 682 people aged 65 years or over . Interventions 330 residents were offered a goal setting and individualised activities of daily living activity programme by a gerontology nurse , reinforced by usual healthcare assistants ; 352 residents received social visits . Main outcome measures Function ( late life function and disability instruments , elderly mobility scale , FICSIT-4 balance test , timed up and go test ) , quality of life ( life satisfaction index , EuroQol ) , and falls ( time to fall over 12 months ) . Secondary outcomes were depressive symptoms and hospital admissions . Results 473 ( 70 % ) participants completed the trial . The programme had no impact overall . However , in contrast to residents with impaired cognition ( no differences between intervention and control group ) , those with normal cognition in the intervention group may have maintained overall function ( late life function and disability instrument total function , P=0.024 ) and lower limb function ( late life function and disability instrument basic lower extremity , P=0.015 ) . In residents with cognitive impairment , the likelihood of depression increased in the intervention group . No other outcomes differed between groups . Conclusion A programme of functional rehabilitation had minimal impact for elderly people in residential care with normal cognition but was not beneficial for those with poor cognition . Trial registration Australian Clinical Trials Register ACTRN12605000667617 PURPOSE OF THE STUDY The purpose of this study was to test the impact of Function-Focused Care for the Cognitively Impaired Intervention on nursing home residents with dementia and the nursing assistants who care for them . DESIGN AND METHODS This was a cluster-r and omized controlled trial using repeated measures . A total of 103 cognitively impaired residents and 77 nursing assistants were recruited from four nursing homes . For residents , outcome measures included function , physical activity ( survey and actigraphy ) , mood , behavior , and adverse events ( falls and hospitalization ) . Main outcome measures for nursing assistants included knowledge , beliefs , and performance of function focused care . RESULTS There were significant improvements in the amount and intensity of physical activity ( by survey and actigraphy ) and physical function in the treatment group . In addition , there was a significant decrease in the number of residents who fell during the treatment period with those in the treatment sites having fewer falls ( 28 % vs. 50 % in the control group ) . Nursing assistants were also observed to be providing a greater percentage of function focused care during resident care interactions in the treatment group at 6 months following the completion of baseline measures . IMPLICATION S This study provides some evidence that nursing home residents with severe cognitive impairment can safely and successfully be engaged in physical and functional activities Background There has been an increasing interest in reablement in Norway recently and many municipalities have implemented this form of rehabilitation despite a lack of robust evidence of its effectiveness . The aim of this study was to investigate the effectiveness of reablement in home-dwelling older adults compared with usual care in relation to daily activities , physical functioning , and health-related quality of life . Methods This is a parallel-group r and omised controlled trial conducted in a rural municipality in Norway . Sixty-one home-dwelling older adults with functional decline were r and omised to an intervention group ( n = 31 ) or a control group ( n = 30 ) . The intervention group received ten weeks of multicomponent home-based rehabilitation . The Canadian Occupational Performance Measure ( COPM ) was used to measure self-perceived activity performance and satisfaction with performance . In addition , physical capacity and health-related quality of life were measured . The participants were assessed at baseline and at 3- and 9-month follow-ups . Results There were significant improvements in mean scores favouring reablement in COPM performance at 3 months with a score of 1.5 points ( p = 0.02 ) , at 9 months 1.4 points ( p = 0.03 ) and overall treatment 1.5 points ( p = 0.01 ) , and for COPM satisfaction at 9 months 1.4 points ( p = 0.03 ) and overall treatment 1.2 points ( p = 0.04 ) . No significant group differences were found concerning COPM satisfaction at 3 months , physical capacity or health-related quality of life . Conclusion A 10-week reablement program result ed in better activity performance and satisfaction with performance on a long-term basis , but not the other outcomes measured . Trial registration The trial was registered in Clinical Trials.gov November 20 , 2012 , identifier NCT02043262 BACKGROUND frail older people often require tailored rehabilitation in order to remain at home , especially following a period of hospitalisation . Restorative care services aim to enhance an older person 's ability to remain improve physical functioning , either at home or in residential care but evidence of their effectiveness is limited . OBJECTIVE to evaluate the effectiveness of a restorative care service on institutional-free survival and health outcomes in frail older people referred for needs assessment in New Zeal and . METHODS a r and omised controlled trial of restorative care or usual care in 105 older people at risk of permanent residential who were follow-up over 24 months . The restorative care service was delivered in short-stay residential care facilities and at participants ' residences with the aim of reducing the requirement for permanent residential care . It included a comprehensive geriatric assessment and care plan developed and delivered , initially by a multi-disciplinary team and subsequently by home care assistants . RESULTS compared with usual care , there was a non-significant absolute risk reduction of 14.3 % for death or permanent residential care ( 8.8 % for residential care and 7.2 % for death alone ) for the restorative care approach . There was no difference in levels of burden among caregivers . CONCLUSIONS restorative care models that utilise case management and multi-disciplinary care may positively impact on institutional-free survival for frail older people without adversely impacting on the health of caregivers INTRODUCTION Health services delivered in an older person 's home are often implemented at a critical juncture in an individual 's functional status . Although homecare has potential to improve this situation , it often focuses on treating disease and ' taking care ' of the patient rather than promoting independence . The aim of restorative homecare is to change the philosophy from one where delivery of care may create dependency to provision of care which maximises independence , self-esteem , self-image and quality of life , and reduces the care required . AIMS To assess impact of a design ated goal facilitation tool on health-related quality of life ( HRQoL ) , social support and physical function among community-dwelling older people referred for homecare . METHODS A total of 205 participants [ mean age 79.1 years , 71.3 % female ( intervention group ) and 76.9 years with 60.8 % female ( control group ) ] were cluster r and omised to an intervention or control assessor . The intervention arm involved participants completing a goal facilitation tool with assessors . This established rehabilitation aims . Control participants received a st and ard needs assessment . Clients from both groups were then referred to a homecare organisation for service delivery . RESULTS There was greater change over time in HRQoL [ measured by Short Form 36 Survey ( SF-36 ) ] in the intervention group ( P = 0.0001 ) . There was a marked variation across homecare providers in types of services provided ( P < 0.001 ) . Identification of a goal did not predict completion of a formalised review of participants ' needs by the homecare organisation . CONCLUSIONS Use of a goal facilitation tool in assessment of an older person 's needs on referral for homecare leads to significant improvements in HRQoL. This may be through a higher proportion of individualised activities tailored to a successful identification of the person 's goals . The findings contribute to greater underst and ing of factors necessary to implement improvements in homecare services for older people A r and omised controlled trial was conducted to test the effectiveness of the Home Independence Program ( HIP ) , a restorative home-care programme for older adults , in reducing the need for ongoing services . Between June 2005 and August 2007 , 750 older adults referred to a home-care service for assistance with their personal care participated in the study and received HIP or ' usual ' home-care services . Service outcomes were compared at 3 and 12 months . Subgroups of 150 from each group were also compared on functional and quality of life measures . Data were analysed by ' intention-to-treat ' and ' as-treated ' . The intention-to-treat analysis showed at 3 and 12 months that the HIP group was significantly less likely to need ongoing personal care [ Odds ratio ( OR ) = 0.18 , 95 % CI = 0.13 - 0.26 , P < 0.001 ; OR = 0.22 , 95 % CI = 0.15 - 0.32 , P < 0.001 ] . Both subgroups showed improvements on the individual outcome measures over time with the only significant differences being found at 12 months for Instrumental Activities of Daily Living ( IADL ) in the as-treated analysis . Contamination of the control group by an increased emphasis on independence across the home-care agency involved , together with other method ological problems encountered , is thought to account for the few differences between groups in individual outcomes . Despite no difference between the groups over time in their overall ADL scores , a significantly smaller proportion of the HIP group required assistance with bathing/showering , the most common reason for referral , at 3 and 12 months . The results support earlier findings that participating in a short-term restorative programme appears to reduce the need for ongoing home care . The implementation of such programmes more broadly throughout Australia could substantially offset the projected increase in dem and for home care associated with the five-fold projected increase in numbers of the oldest old expected over the next 40 years Due to the ageing population , there is an increased dem and for home care services . Restorative care is one approach to improving home care services , although there is little evidence to support its use in the community setting . The objective of this trial was to evaluate the impact of a restorative home care service for community-dwelling older people . The study was a cluster r and omised controlled trial undertaken at a home care agency in New Zeal and . The study period was from December 2005 to May 2007 . Older people were interviewed face-to-face at baseline , four and 7 months . A total of 186 older people who received assistance from a home care agency participated in the study , 93 received restorative home care and 93 older people received usual home care . The primary outcome measure was change in health-related quality of life ( measured by the Short Form 36 [ SF36 ] Health Survey ) . Secondary outcomes were the physical , mental , and social well-being of older people ( Nottingham Extended Activities of Daily Living , Timed Up and Go , Mastery scale , Duke Social Support Index ) . Findings revealed that compared with usual care ,
Output:
| Quantitative data were promising in regards to residents ’ depression symptoms , functioning and social care related quality of life .
Conclusion It is feasible to deliver and evaluate LifeFul . |
MS213506 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: OBJECTIVE Adequate Zn and Mg intakes may be beneficial for the prevention and treatment of mental health problems , such as depression , anxiety and attention-deficit hyperactivity disorder . We aim ed to investigate the prospect i ve association between dietary intakes of Zn and Mg and internalising and externalising behaviour problems in a population -based cohort of adolescents . DESIGN Prospect i ve analysis ( general linear mixed models ) of dietary intakes of Zn and Mg assessed using a vali date d FFQ and mental health symptoms assessed using the Youth Self-Report ( YSR ) , adjusting for sex , physical activity , family income , supplement status , dietary misreporting , BMI , family functioning and energy intake . SETTING Western Australian Pregnancy Cohort ( Raine ) Study . SUBJECTS Adolescents ( n 684 ) at the 14- and 17-year follow-ups . RESULTS Higher dietary intake of Mg ( per SD increase ) was significantly associated with reduced externalising behaviours ( β = -1.45 ; 95 % CI -2.40 , -0.50 ; P = 0.003 ) . There was a trend towards reduced externalising behaviours with higher Zn intake ( per SD increase ; β = -0.73 ; 95 % CI -1.57 , 0.10 ; P = 0.085 ) . CONCLUSIONS The study shows an association between higher dietary Mg intake and reduced externalising behaviour problems in adolescents . We observed a similar trend , although not statistically significant , for Zn intake . R and omised controlled trials are necessary to determine any benefit of micronutrient supplementation in the prevention and treatment of mental health problems in adolescents Background Polyunsaturated fatty acids are essential nutrients for humans . They are structural and functional components of cell membranes and pre-stages of the hormonally and immunologically active eicosanoids . Recent discoveries have shown that the long-chained omega-3 fatty acids eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) also play an important role in the central nervous system . They are essential for normal brain functioning including attention and other neuropsychological skills . Material s and methods In our large observational study we monitored 810 children from 5 to 12 years of age referred for medical help and recommended for consuming polyunsaturated fatty acids ( PUFA ) in combination with zinc and magnesium by a physician over a period of at least 3 months . The food supplement ESPRICO ® ( further on referred to as the food supplement ) is developed on the basis of current nutritional science and containing a combination of omega-3 and omega-6 fatty acids as well as magnesium and zinc . Study objective was to evaluate the nutritional effects of the PUFA-zinc-magnesium combination on symptoms of attention deficit , impulsivity , and hyperactivity as well as on emotional problems and sleep related parameters . Assessment was performed by internationally st and ardised evaluation scales , i.e. SNAP-IV and SDQ . Tolerance ( adverse events ) and acceptance ( compliance ) of the dietary therapy were documented . Results After 12 weeks of consumption of a combination of omega-3 and omega-6 fatty acids as well as magnesium and zinc most subjects showed a considerable reduction in symptoms of attention deficit and hyperactivity/impulsivity assessed by SNAP-IV . Further , the assessment by SDQ revealed fewer emotional problems at the end of the study period compared to baseline and also sleeping disorders . Mainly problems to fall asleep , decreased during the 12 week nutritional therapy . Regarding safety , no serious adverse events occurred . A total of 16 adverse events with a possible causal relationship to the study medication were reported by 14 children ( 1.7 % ) and only 5.2 % of the children discontinued the study due to acceptance problems . Continuation of consumption of the food supplement was recommended by the paediatricians for 61.1 % of the children . Conclusion Our results suggest a beneficial effect of a combination of omega-3 and omega-6 fatty acids as well as magnesium and zinc consumption on attentional , behavioural , and emotional problems of children and adolescents . Thus , considering the behavioural benefit in combination with the low risk due to a good safety profile , the dietary supplementation with PUFA in combination with zinc and magnesium can be recommended Children with ADHD are ' a group at risk ' as far as their further emotional and social development and educational possibilities are concerned , and the consequences of the lack of an appropriate therapy appears to be serious . Some of these children do not respond to prevailing therapy methods . It is reported that dietetic factors can play a significant role in the etiology of ADHD syndrome , and magnesium deficiency can help in revealing hyperactivity in children . The aim of our work was to assess the influence of magnesium supplementation on hyperactivity in patients with ADHD . The examination comprised 50 hyperactive children , aged 7 - 12 years , who fulfilled DSM IV criteria for ADHD syndrome , with recognized deficiency of magnesium in the blood ( blood serum and red blood cells ) and in hair using atomic absorption spectroscopy . In the period of 6 months those examined regularly took magnesium preparations in a dose of about 200 mg/day . 30 of those examined with ADHD showed coexisting disorders specific to developmental age , and 20 of them showed disruptive behaviour . The control group consisted of 25 children with ADHD and magnesium deficiency , who were treated in a st and ard way , without magnesium preparations . 15 members of this group showed coexisting disorders specific for developmental age , and 10 members showed disruptive behaviour . Hyperactivity was assessed with the aid of psychometric scales : the Conners Rating Scale for Parents and Teachers , Wender 's Scale of Behavior and the Quotient of Development to Freedom from Distractibility . In the group of children given 6 months of magnesium supplementation , independently of other mental disorders coexisting with hyperactivity , an increase in magnesium contents in hair and a significant decrease of hyperactivity of those examined has been achieved , compared to their clinical state before supplementation and compared to the control group which had not been treated with magnesium Levels of calcium in plasma , red blood cells , and mononuclear blood cells , levels of calcium in plasma , and the plasma calcium-to-magnesium ratio were measured at baseline and after 3 weeks of each drug phase of a double-blind , placebo-controlled study of methylpheni date and dextroamphetamine in hyperactive boys . Levels of magnesium in plasma were significantly higher after 3 weeks of dextroamphetamine treatment , and the calcium-to-magnesium ratio was significantly lower after 3 weeks of either drug compared with the baseline or placebo condition . There was no change in magnesium levels in red blood cells or mononuclear blood cells . These measures were obtained 30 minutes before the morning dose and at 9 a.m. , 9:30 a.m. , 10:30 a.m. , 11:00 a.m. , and noon on the last day of each 3-week phase . Analysis of variance revealed a drug effect on plasma magnesium and on the calcium-to-magnesium ratio but no drug x time interaction . Although these changes were not correlated with the time course of acute symptomatic response to stimulant therapy , the decrease in the ratio may be relevant to side effects and treatment resistance associated with stimulant use A positive influence of magnesium in the prevention and treatment of hyperactivity in children is more and more frequently raised in the literature . The aim of our work was to estimate magnesium contents in children with attention deficit hyperactivity disorder , ( ADHD ) . The investigations comprised 116 children ( 94 boys and 20 girls ) , aged 9 - 12 years , with recognized ADHD . In 68 out of 116 patients examined ADHD occurred with other coexisting disorders specific to the developmental age and in the remaining 48 patients it occurred together with disruptive behaviour . Magnesium levels have been determined in blood serum , red blood cells and in hair with the aid of atomic absorption spectroscopy . Magnesium deficiency was found in 95 per cent of those examined , most frequently in hair ( 77.6 per cent ) , in red blood cells ( 58.6 per cent ) and in blood serum ( 33.6 per cent ) of children with ADHD . The conclusion from the investigations is that magnesium deficiency in children with ADHD occurs more frequently than in healthy children . Analysis of the material indicated the correlation between levels of magnesium and the quotient of development to freedom from distractibility
Output:
| HighlightsWe found significantly lower blood magnesium levels , either in plasma or serum , in ADHD children than those in controls .
The serum magnesium levels in ADHD children was significantly lower than those in controls .
Also , in situation of definite diagnosis based upon DSM system , the subgroup meta‐ analysis revealed similar result .Finally , we also found significantly lower hair magnesium levels in children diagnosed with ADHD than those in controls |
MS213507 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The purpose of this study was to evaluate the effects of a brief intervention programme on STD knowledge , condom use and gonorrhoea incidence among sex workers in Singapore . A controlled before- and -after study design with non-r and om assignment of sex workers was used , supplemented by multivariate analysis to adjust for baseline differences . Control ( n = 221 , denoted C1 ) and experimental ( n = 221 , denoted E1 ) groups were interviewed on 2 occasions 3 months apart . Two supplementary groups were interviewed once each at the end of the 3-month period ( n = 145 who had received the intervention and n = 151 who had not ) . Basic knowledge of STD symptoms and HIV transmission was high in all groups . There were misconceptions about casual transmission of HIV which improved dramatically at the second interview for group El ( from 37–56 % correct responses to 82–90 % ) . Overall condom use was high ( about 75 % ) and did not change after the intervention . Gonorrhoea rates were correspondingly low ( 0.4 episodes/worker/year ) and also did not change . This brief intervention improved the STD knowledge of sex workers . However , behaviour as measured by reported condom use and gonorrhoea incidence did not change . Implication s for future intervention programmes are discussed Background Violence against female sex workers ( FSWs ) can impede HIV prevention efforts and contravenes their human rights . We developed a multi-layered violence intervention targeting policy makers , secondary stakeholders ( police , lawyers , media ) , and primary stakeholders ( FSWs ) , as part of wider HIV prevention programming involving > 60,000 FSWs in Karnataka state . This study examined if violence against FSWs is associated with reduced condom use and increased STI/HIV risk , and if addressing violence against FSWs within a large-scale HIV prevention program can reduce levels of violence against them . Methods FSWs were r and omly selected to participate in polling booth surveys ( PBS 2006 - 2008 ; short behavioural question naires administered anonymously ) and integrated behavioural-biological assessment s ( IBBAs 2005 - 2009 ; administered face-to-face ) . Results 3,852 FSWs participated in the IBBAs and 7,638 FSWs participated in the PBS . Overall , 11.0 % of FSWs in the IBBAs and 26.4 % of FSWs in the PBS reported being beaten or raped in the past year . FSWs who reported violence in the past year were significantly less likely to report condom use with clients ( zero unprotected sex acts in previous month , 55.4 % vs. 75.5 % , adjusted odds ratio ( AOR ) 0.4 , 95 % confidence interval ( CI ) 0.3 to 0.5 , p < 0.001 ) ; to have accessed the HIV intervention program ( ever contacted by peer educator , 84.9 % vs. 89.6 % , AOR 0.7 , 95 % CI 0.4 to 1.0 , p = 0.04 ) ; or to have ever visited the project sexual health clinic ( 59.0 % vs. 68.1 % , AOR 0.7 , 95 % CI 0.6 to 1.0 , p = 0.02 ) ; and were significantly more likely to be infected with gonorrhea ( 5.0 % vs. 2.6 % , AOR 1.9 , 95 % CI 1.1 to 3.3 , p = 0.02 ) . By the follow-up surveys , significant reductions were seen in the proportions of FSWs reporting violence compared with baseline ( IBBA 13.0 % vs. 9.0 % , AOR 0.7 , 95 % CI 0.5 to 0.9 p = 0.01 ; PBS 27.3 % vs. 18.9 % , crude OR 0.5 , 95 % CI 0.4 to 0.5 , p < 0.001 ) . Conclusions This program demonstrates that a structural approach to addressing violence can be effectively delivered at scale . Addressing violence against FSWs is important for the success of HIV prevention programs , and for protecting their basic human rights Background : In preparation for a r and omized controlled trial ( RCT ) , we conducted a pilot RCT of the acceptability and feasibility of diaphragms and c and i date vaginal microbicide for sexually transmitted infection prevention among high-risk women in Madagascar . Methods : Participants were r and omized to four arms : ( 1 ) diaphragm ( worn continuously ) with Acidform ™ applied in the dome ; ( 2 ) diaphragm ( worn continuously ) with placebo gel hydroxyethylcellulose ( HEC ) in the dome ; ( 3 ) HEC applied intravaginally before sex ; ( 4 ) Acidform applied intravaginally before sex . All women were given condoms . Participants were followed weekly for 4 weeks . We fit unadjusted negative binomial regression models with robust variance estimators to generate the proportion of sex acts with casual partners where condoms and experimental study products were used . Results : Retention was 98 % among 192 participants . Experimental product use with casual partners was high , reported in 85 % , 91 % , 74 % , and 81 % of sex acts for women in the Acidform-diaphragm , HEC-diaphragm , HEC-alone , and Acidform-alone arms , respectively . However , the proportion reporting product use during 100 % of acts with casual partners over the full follow-up period was much lower : 28 % to 29 % in the gel-diaphragm arms and 6 % to 10 % in gel-alone arms . Women used condoms in 62 % to 67 % of sex acts with casual partners , depending on the r and omization arm . Participants found diaphragms easy to insert ( 97 % ) and remove ( 96 % ) . Acidform users ( with or without the diaphragm ) reported more genitourinary symptoms than HEC users ( 14 % vs. 5 % of visits ) . Conclusions : A sexually transmitted infection prevention RCT of c and i date microbicide with and without the diaphragm appears acceptable and feasible in this population Objectives : To investigate changes in HIV-related behaviours among female sex workers ( FSW ) and associations with services coverage rates . Methods : Behavioural surveillance data from Sichuan , China , were analysed . A mapping exercise was conducted ; FSW were recruited from r and omly selected sex-work establishments in 19 sites in Sichuan , China , from 2003 ( n = 7068 ) , 2004 ( n = 6875 ) and 2005 ( n = 6833 ) . Results : Site variations were substantial . The r and om effect pooled AOR comparing the prevalence of condom use with regular sex partners , possession of condoms , HIV-related knowledge , HIV antibody testing and services coverage rates in 2005 versus 2003 ranged from 1.42 to 20.35 . The 95 % CI of these pooled AOR all excluded 1.0 ; hence rejecting the null hypothesis that such OR were not different from 1.0 . Most of the AOR of these evaluative parameters ( indicator of improvement ) for the 19 individual sites in 2004 and 2005 ( vs 2003 ) were significantly associated with coverage rates ( Spearmen correlation coefficients = 0.35 to 0.67 , p<0.05 ) . Conclusions : Improvements were observed in relevant behaviours and coverage rates and the two were associated with each other Objectives To examine the impact of a large-scale HIV prevention programme for female sex workers ( FSW ) in Karnataka state , south India , on the prevalence of HIV/sexually transmitted infections ( STI ) , condom use and programme coverage . Methods Baseline and follow-up integrated biological and behavioural surveys were conducted on r and om sample s of FSW in five districts in Karnataka between 2004 and 2009 . Results 4712 FSW participated in the study ( baseline 2312 ; follow-up 2400 ) , with follow-up surveys conducted 28–37 months after baseline . By follow-up , over 85 % of FSW reported contact by a peer educator and having visited a project STI clinic . Compared with baseline , there were reductions in the prevalence of HIV ( 19.6 % vs 16.4 % , adjusted odds ratio ( AOR ) 0.81 , 95 % CI 0.67 to 0.99 , p=0.04 ) ; high-titre syphilis ( 5.9 % vs 3.4 % , AOR 0.53 , 95 % CI 0.37 to 0.77 , p=0.001 ) ; and chlamydia and /or gonorrhoea ( 8.9 % vs 7.0 % , AOR 0.72 , 95 % CI 0.54 to 0.94 , p=0.02 ) . Reported condom use at last sex increased significantly for repeat clients ( 66.1 % vs 84.1 % , AOR 1.98 , 95 % CI 1.58 to 2.48 , p<0.001 ) and marginally for occasional clients ( 82.9 % vs 88.0 % , AOR 1.22 , 95 % CI 0.89 to 1.66 , p=0.2 ) , but remained stable for regular partners ( 32 % ) . Compared with street and home-based FSW , brothel-based FSW were at highest risk of HIV and STI , despite high levels of reported condom use . Conclusions This large-scale HIV prevention programme for FSW achieved reductions in HIV and STI prevalence , high rates of condom use with clients and high rates of programme coverage . Improved strategies to increase condom use with regular partners and reduce the vulnerability of brothel-based FSW to HIV are required Objective : To evaluate the effectiveness of a clinician-delivered intervention , implemented during routine clinical care , in reducing unprotected sexual behavior of HIV-infected patients . Design : A prospect i ve clinical trial comparing the impact of a clinician-delivered intervention arm vs. a st and ard-of-care control arm on unprotected sexual behavior of HIV-infected patients . Setting : The 2 largest HIV clinics in Connecticut . Participants : A total of 497 HIV-infected patients , aged ≥18 years , receiving HIV clinical care . Intervention : HIV clinical care providers conducted brief client-centered interventions at each clinical encounter that were design ed to help HIV-infected patients reduce unprotected sexual behavior . Main Outcome Measures : Unprotected insertive and receptive vaginal and anal intercourse and unprotected insertive oral sex ; unprotected insertive and receptive vaginal and anal intercourse only . Results : HIV-infected patients who received the clinician-delivered intervention showed significantly reduced unprotected insertive and receptive vaginal and anal intercourse and insertive oral sex over a follow-up interval of 18 months ( P < 0.05 ) . These behaviors increased across the study interval for patients in the st and ard-of-care control arm ( P < 0.01 ) . For the measure of unprotected insertive and receptive vaginal and anal sex only , there was a trend toward a reduction in unprotected sex among intervention arm participants over time ( P < 0.09 ) , and a significant increase in unprotected sex in the st and ard-of-care control arm ( P < 0.01 ) . Conclusions : A clinician-delivered HIV prevention intervention targeting HIV-infected patients result ed in reductions in unprotected sex . Interventions of this kind should be integrated into routine HIV clinical care Background and Objective : The Sonagachi Project in Calcutta , India , organized sex workers to improve working conditions . Goal : To compare rates of sexually transmitted diseases between the Sonagachi Project and other areas in which only the National AIDS Control Organization ( NACO ) interventions were implemented . Study : A cross-sectional survey of r and omly selected female sex workers . Results : There was no difference in the prevalence of all STDs between the 2 areas ; both were lower than reported in other surveys in 1992 . Analysis using propensity scores also failed to demonstrate any difference . The number of preventive activities was similar in the Sonagachi and NACO-only areas but was more prevalent than in 1992 . Sex workers in the Sonagachi area had better treatment-seeking behavior and attitudes . Both the Sonagachi and NACO strategies have result ed in lower STD rates , but the Sonagachi Project also increased the proportion who had an optimistic attitude and increased prevention and treatment-seeking behavior Background India has an estimated 2.0 million to 3.1 million people living with HIV ; it has the highest number of HIV-positive people in Asia and ranks third in the world . The Frontiers Prevention Project ( FPP ) was implemented in 2002 to conduct targeted prevention intervention geared towards female sex workers ( FSW ) and men who have sex with men ( MSM ) in the state of And hra Pradesh ( AP ) . This paper reports the overall changes in behaviour and STI outcomes between 2003/4 and 2007 and also describes the changes attributed to the FPP . Methods The evaluation used two cross-sectional surveys among MSM and FSW at 24 sites in AP . Surveys were implemented using a similar methodology . Univariate analyses were conducted by comparing means : baseline vs. four-year follow-up and FPP vs. non-FPP . For both MSM and FSW , r and om and fixed-effects logit regression models at the site level were estimated for condom
Output:
| AUTHORS ' CONCLUSIONS Available evidence nevertheless suggests that compared with st and ard care or no intervention , behavioral interventions are effective in reducing HIV and the incidence of STIs amongst female sex workers ( FSWs ) .
Given the benefits of social cognitive theory and the promotion of condom use in reducing HIV/STI and the public health need to control transmission amongst FSWs , there is a clear finding in favour of behavioral interventions . |
MS213508 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background Prevalence of type 2 diabetes ( T2D ) is increasing worldwide . T2D prevention by lifestyle intervention is effective . Pragmatic scalable interventions are needed , with evidence to efficiently target and monitor such interventions . We report pooled analyses of data from three European trial cohorts : to analyse T2D incidence , sustained weight loss and utility of risk predictors . Methods We analysed data on 749 adults with impaired glucose tolerance ( 278 men and 471 women , mean age 56 years , mean BMI 31 kgm−2 ) recruited between 1993 and 2003 , and r and omised to intensive lifestyle intervention ( I ) or lifestyle advice control ( C ) . The intervention aim ed to increase physical activity , modify diet , and promote weight loss≥5 % . Using Cox-regression survival analysis , we assessed T2D incidence and the impact on T2D incidence of sustained weight loss , and of baseline cut-point values of FINDRISC score , fasting plasma glucose ( FPG ) , and HbA1c . Results Mean follow-up duration was 3.1 years . T2D was diagnosed in 139 participants ( I = 45/379 , C = 94/370 ) . Cumulative T2D incidence was 57 % lower in the intervention compared with the control group ( HR 0.42 ( 95 % CI 0.29 to 0.60 ) P<0.001 ) . Participants with ≥5 % weight loss at one year had 65 % lower T2D incidence ( HR 0.35 ( 95 % CI 0.22 to 0.56 ) P<0.001 ) ; maintaining ≥5 % weight loss for two and three years further reduced T2D incidence . Recommended cut-points to identify those at high risk for T2D would have identified different proportions of European Diabetes Prevention Study ( EDIPS ) participants with similar hazard-ratios for intervention effect . Conclusions Pooled analysis of EDIPS trial data reinforces evidence for T2D prevention by lifestyle intervention . Analysis showed the preventive effect of ≥5 % weight loss , especially if maintained long term , which has utility for intervention monitoring . Analysis of proposed cut-points demonstrates difficulties in balancing risk and benefit , to efficiently target interventions and suggests evidence is needed to define clinical policy . Trial registration s The Finnish Diabetes Prevention study , Helsinki , Finl and : Clinical Trials.gov ; NCT00518167 The SLIM diabetes prevention study , Maastricht , The Netherl and s : Clinical Trials.gov ; NCT00381186 The EDIPS-Newcastle diabetes prevention study , Newcastle upon Tyne , UK : International St and ard R and omised Controlled Trial Number ; IS RCT N15670600 OBJECTIVE Changing dietary and physical activity habits has the potential to postpone or prevent the development of type 2 diabetes . However , it needs to be assessed whether moderate interventions , in agreement with current guidelines for the general population , are effective . We evaluated the impact of a 2-year combined diet and physical activity intervention program on glucose tolerance in Dutch subjects at increased risk for developing diabetes . RESEARCH METHODS AND PROCEDURES Subjects with glucose intolerance were r and omly assigned to either the lifestyle intervention group ( INT ) or control group ( CON ) . The INT received regular dietary advice and was stimulated to increase their physical activity . The CON received a brief leaflet about healthy diet and increased physical activity . Primary outcome measure was the change in glucose tolerance . RESULTS In total , 88 subjects completed 2 years of intervention ( 40 subjects in the INT , 48 subjects in the CON , mean BMI 29.4 kg/m2 ) . Subjects in the INT reduced their body weight , waist circumference , and ( saturated ) fat intake and improved their aerobic capacity . Two-hour plasma glucose concentration declined from 8.7 to 8.0 mM in the INT and rose from 8.6 to 9.4 mM in the CON ( p < 0.01 ) . Subjects adherent to both the diet and exercise intervention showed the largest reduction in 2-hour glucose levels . DISCUSSION Our results showed that a lifestyle intervention program according to general recommendations improves glucose tolerance , even in a less obese and more physical active population . Furthermore , our results underscore the importance of combining diet and physical activity to improve glucose tolerance and insulin resistance OBJECTIVE To test the effects of two Mediterranean diet ( MedDiet ) interventions versus a low-fat diet on incidence of diabetes . RESEARCH DESIGN AND METHODS This was a three-arm r and omized trial in 418 nondiabetic subjects aged 55–80 years recruited in one center ( PREDIMED-Reus , northeastern Spain ) of the Prevención con Dieta Mediterránea [ PREDIMED ] study , a large nutrition intervention trial for primary cardiovascular prevention in individuals at high cardiovascular risk . Participants were r and omly assigned to education on a low-fat diet ( control group ) or to one of two MedDiets , supplemented with either free virgin olive oil ( 1 liter/week ) or nuts ( 30 g/day ) . Diets were ad libitum , and no advice on physical activity was given . The main outcome was diabetes incidence diagnosed by the 2009 American Diabetes Association criteria . RESULTS After a median follow-up of 4.0 years , diabetes incidence was 10.1 % ( 95 % CI 5.1–15.1 ) , 11.0 % ( 5.9–16.1 ) , and 17.9 % ( 11.4–24.4 ) in the MedDiet with olive oil group , the MedDiet with nuts group , and the control group , respectively . Multivariable adjusted hazard ratios of diabetes were 0.49 ( 0.25–0.97 ) and 0.48 ( 0.24–0.96 ) in the MedDiet supplemented with olive oil and nuts groups , respectively , compared with the control group . When the two MedDiet groups were pooled and compared with the control group , diabetes incidence was reduced by 52 % ( 27–86 ) . In all study arms , increased adherence to the MedDiet was inversely associated with diabetes incidence . Diabetes risk reduction occurred in the absence of significant changes in body weight or physical activity . CONCLUSIONS MedDiets without calorie restriction seem to be effective in the prevention of diabetes in subjects at high cardiovascular risk OBJECTIVE To examine associations between type 2 diabetes and fiber , glycemic load ( GL ) , dietary glycemic index ( GI ) , and fiber-rich foods . RESEARCH DESIGN AND METHODS This was a prospect i ve study of 36,787 men and women aged 40 - 69 years without diabetes . For all self-reported cases of diabetes at 4-year follow-up , confirmation of diagnosis was sought from medical practitioners . Case subjects were those who reported diabetes at follow-up and for whom there was no evidence that they did not have type 2 diabetes . Data were analyzed with logistic regression , adjusting for country of birth , physical activity , family history of diabetes , alcohol and energy intake , education , 5-year weight change , sex , and age . RESULTS Follow-up was completed by 31,641 ( 86 % ) participants , and 365 cases were identified . The odds ratio ( OR ) for the highest quartile of white bread intake compared with the lowest was 1.37 ( 95 % CI 1.04 - 1.81 ; P for trend = 0.001 ) . Intakes of carbohydrate ( OR per 200 g/day 0.58 , 0.36 - 0.95 ) , sugars ( OR per 100 g/day 0.61 , 0.47 - 0.79 ) , and magnesium ( OR per 500 mg/day 0.62 , 0.43 - 0.90 ) were inversely associated with incidence of diabetes , whereas intake of starch ( OR per 100 g/day 1.47 , 1.06 - 2.05 ) and dietary GI ( OR per 10 units 1.32 , 1.05 - 1.66 ) were positively associated with diabetes . These relationships were attenuated after adjustment for BMI and waist-to-hip ratio . CONCLUSIONS Reducing dietary GI while maintaining a high carbohydrate intake may reduce the risk of type 2 diabetes . One way to achieve this would be to substitute white bread with low-GI breads Background The heterogeneity statistic I2 , interpreted as the percentage of variability due to heterogeneity between studies rather than sampling error , depends on precision , that is , the size of the studies included . Methods Based on a real meta- analysis , we simulate artificially ' inflating ' the sample size under the r and om effects model . For a given inflation factor M = 1 , 2 , 3 , ... and for each trial i , we create a M-inflated trial by drawing a treatment effect estimate from the r and om effects model , using si2MathType@MTEF@5@5@+=feaagaart1ev2aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacPC6xNi = xH8viVGI8Gi = hEeeu0xXdbba9frFj0xb9qqpG0dXdb9aspeI8k8fiI+fsY = rqGqVepae9pg0db9vqaiVgFr0xfr = xfr = xc9adbaqaaeGaciGaaiaabeqaaeqabiWaaaGcbaGaem4Cam3aa0baaSqaaiabdMgaPbqaaiabikdaYaaaaaa@2FBE@/M as within-trial sampling variance . Results As precision increases , while estimates of the heterogeneity variance τ2 remain unchanged on average , estimates of I2 increase rapidly to nearly 100 % . A similar phenomenon is apparent in a sample of 157 meta-analyses . Conclusion When deciding whether or not to pool treatment estimates in a meta- analysis , the yard-stick should be the clinical relevance of any heterogeneity present . τ2 , rather than I2 , is the appropriate measure for this purpose Background : Weight loss is a key factor in reducing diabetes risk . The Diabetes Prevention Program ( DPP ) is a completed clinical trial that r and omly assigned individuals at high risk of diabetes to a placebo ( PLBO ) , metformin ( MET ) , or intensive lifestyle intervention ( ILS ) group , which included physical activity ( PA ) and reduced dietary fat intake . Objective : We aim ed to evaluate the associations between diet and weight at baseline and to identify specific dietary factors that predicted weight loss among DPP participants . Methods : Diet was assessed by a food frequency question naire . The associations between intakes of macronutrients and various food groups and body weight among DPP participants at baseline were assessed by linear regression , adjusted for race/ethnicity , age , sex , calorie intake , and PA . Models that predicted weight loss at year 1 were adjusted for baseline weight , change in calorie intake , and change in PA and stratified by treatment allocation ( MET , ILS , and PLBO ) . All results are presented as estimates ± SEs . Results : A total of 3234 participants were enrolled in the DPP ; 2924 had completed dietary data ( 67.5 % women ; mean age : 50.6 ± 10.7 y ) . Adjusted for calorie intake , baseline weight was negatively associated with carbohydrate intake ( -1.14 ± 0.18 kg body weight/100 kcal carbohydrate , P < 0.0001 ) and , specifically , dietary fiber ( -1.26 ± 0.28 kg/5 g fiber , P < 0.0001 ) . Baseline weight was positively associated with total fat ( 1.25 ± 0.21 kg/100 kcal , P < 0.0001 ) , saturated fat ( 1.96 ± 0.46 kg/100 kcal , P < 0.0001 ) , and protein ( 0.21 ± 0.05 kg/100 kcal , P < 0.0001 ) . For all groups , weight loss after 1 y was associated with increases in carbohydrate intake , specifically dietary fiber , and decreases in total fat and saturated fat intake . Conclusions : Higher carbohydrate consumption among DPP participants , specifically high-fiber carbohydrates , and lower total and saturated fat intake best predicted weight loss when adjusted for changes in calorie intake . Our results support the benefits of a high-carbohydrate , high-fiber , low-fat diet in the context of overall calorie reduction leading to weight loss , which may prevent diabetes in high-risk individuals . This trial was registered at clinical trials.gov as NCT00004992 Background / objectives Vegetarian diets are inversely associated with diabetes in Westerners but their impact on Asians — whose pathophysiology differ from Westerners — is unknown . We aim to investigate the association between a vegetarian diet , change in dietary patterns and diabetes risk in a Taiwanese Buddhist population . Methods We prospect
Output:
| We conclude that T2D is preventable by changing lifestyle and the risk reduction is sustained for many years after the active intervention ( high certainty of evidence ) .
There is limited or insufficient data to show that prevention of T2D by lifestyle changes results in a lower risk of cardiovascular and microvascular complications |
MS213509 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Gut microbiota is now known to control glucose metabolism . Previous studies have shown that probiotics and prebiotics may improve glucose metabolism , but their effects have not been studied in combination with drug therapy . The aim of this study was to investigate whether probiotics and prebiotics combined with drug therapy affect diabetic outcomes . Methods Two different study design s were used to test gut microbiota modulating treatments with metformin ( MET ) or sitagliptin ( SITA ) in male C57Bl/6J mice . In Design 1 , diabetes was induced with four-week feeding with a ketogenic , 72 kcal% fat diet with virtually no carbohydrates . Mice were then r and omly divided into four groups ( n = 10 in each group ) : ( 1 ) vehicle , ( 2 ) Bifidobacterium animalis ssp . lactis 420 ( B420 ) ( 109 CFU/day ) , ( 3 ) MET ( 2 mg/mL in drinking water ) , or ( 4 ) MET + B420 ( same doses as in the MET and B420 groups ) . After another 4 weeks , glucose metabolism was assessed with a glucose tolerance test . Fasting glucose , fasting insulin and HOMA-IR were also assessed . In Design 2 , mice were fed the same 72 kcal% fat diet to induce diabetes , but they were simultaneously treated within their respective groups ( n = 8 in each group ) : ( 1 ) non-diabetic healthy control , ( 2 ) vehicle , ( 3 ) SITA [ 3 mg/(kg*day ) ] ( 4 ) SITA with prebiotic polydextrose ( PDX ) ( 0.25 g/day ) , ( 5 ) SITA with B420 ( 109 CFU/day ) , and ( 6 ) SITA + PDX + B420 . Glucose metabolism was assessed at 4 weeks , and weight development was monitored for 6 weeks . Results In Design 1 , with low-dose metformin , mice treated with B420 had a significantly lower glycemic response ( area under the curve ) ( factorial experiment , P = 0.002 ) and plasma glucose concentration ( P = 0.02 ) compared to mice not treated with B420 . In Design 2 , SITA + PDX reduced glycaemia in the oral glucose tolerance test significantly more than SITA only ( area under the curve reduced 28 % , P < 0.0001 ) . In addition , B420 , PDX or B420+PDX , together with SITA , further decreased fasting glucose concentrations compared to SITA only ( −19.5 , −40 and −49 % , respectively , P < 0.01 for each comparison ) . The effect of PDX may be due to its ability to increase portal vein GLP-1 concentrations together with SITA ( P = 0.0001 compared to vehicle ) whereas SITA alone had no statistically significant effect compared to vehicle ( P = 0.14 ) . Conclusions This study proposes that combining probiotics and /or prebiotics with antidiabetic drugs improves glycemic control and insulin sensitivity in mice . Mechanisms could be related to incretin secretion Background Recently , the relationship between gut microbiota and obesity has been highlighted . The present r and omized , double-blind , placebo-controlled study aim ed to evaluate the efficacy of transglucosidase ( TGD ) in modulating blood glucose levels and body weight gain in patients with type 2 diabetes mellitus ( T2DM ) and to clarify the underlying mechanism by analyzing the gut microbiota of T2DM patients . Methods This study included 60 patients who received placebo or TGD orally ( 300 or 900 mg/day ) for 12 weeks , and blood and fecal sample s were collected before and after 12 weeks . Comparisons of fecal bacterial communities were performed before and after the TGD treatment and were performed between T2DM patients and 10 healthy individuals , using the terminal-restriction fragment length polymorphism analysis . Results The Clostridium cluster IV and subcluster XIVa components were significantly decreased , whereas the Lactobacillales and Bifidobacterium population s significantly increased in the T2DM patients compared with the healthy individuals . By dendrogram analysis , most of the healthy individuals ( 6/10 ) and T2DM patients ( 45/60 ) were classified into cluster I , indicating no significant difference in fecal bacterial communities between the healthy individuals and the T2DM patients . In the placebo and TGD groups , the bacterial communities were generally similar before and after the treatment . However , after 12 weeks of TGD therapy , the Bacteroidetes-to-Firmicutes ratio in the TGD groups significantly increased and was significantly higher compared with that in the placebo group , indicating that TGD improved the growth of the fecal bacterial communities in the T2DM patients . Conclusions Therefore , TGD treatment decreased blood glucose levels and prevented body weight gain in the T2DM patients by inducing the production of oligosaccharides in the alimentary tract and modulating gut microbiota composition . Trial registration UMIN-CTR A high-fat diet ( HFD ) induces obesity and the associated increases in blood glucose and inflammation through changes in gut microbiota , endotoxemia , and increased gut permeability . To counteract this , research ers have suggested that the use of probiotics that suppress production of proinflammatory lipopolysaccharide ( LPS ) . Here , we tested whether Lactobacillus sakei OK67 , which inhibits gut microbiota LPS production selected from among the lactic acid bacteria isolated from kimchi , exerted antihypoglycemic or anti-inflammatory effects in HFD-fed mice . Mice were r and omly divided into 2 groups and fed an HFD or a low-fat diet for 4 weeks . These groups were further subdivided ; 1 subgroup was treated with L sakei OK67 and fed the experimental diet for 4.5 weeks , whereas the other subgroup was fed the experimental diet alone . L sakei OK67 treatment lowered HFD-elevated LPS levels in blood and colonic fluid and significantly decreased HFD-elevated fasting blood glucose levels and the area under the curve in an oral glucose tolerance test . L sakei OK67 treatment inhibited HFD-induced body and epididymal fat weight gains , suppressed HFD-induced tumor necrosis factor-α and interleukin-1β expression and nuclear factor-κB activation in the colon , and significantly increased HFD-suppressed interleukin-10 and tight junction protein expression in the colon . Oral administration of L sakei OK67 significantly downregulated HFD-induced expression of peroxisome proliferator-activated receptor γ , fatty acid synthase , and tumor necrosis factor-α in adipose tissue . In addition , L sakei OK67 treatment strongly inhibited nuclear factor-κB activation in LPS-stimulated peritoneal macrophages . We report that L sakei OK67 ameliorates HFD-induced hyperglycemia and obesity by reducing inflammation and increasing the expression of colon tight junction proteins in mice The purpose of the present study was to determine whether probiotic supplementation ( Lactobacillus casei Shirota ( LcS ) ) prevents diet-induced insulin resistance in human subjects . A total of seventeen healthy subjects were r and omised to either a probiotic ( n 8) or a control ( n 9 ) group . The probiotic group consumed a LcS-fermented milk drink twice daily for 4 weeks , whereas the control group received no supplementation . Subjects maintained their normal diet for the first 3 weeks of the study , after which they consumed a high-fat ( 65 % of energy ) , high-energy ( 50 % increase in energy intake ) diet for 7 d. Whole-body insulin sensitivity was assessed by an oral glucose tolerance test conducted before and after overfeeding . Body mass increased by 0·6 ( SE 0·2 ) kg in the control group ( P < 0·05 ) and by 0·3 ( SE 0·2 ) kg in the probiotic group ( P>0·05 ) . Fasting plasma glucose concentrations increased following 7 d of overeating ( control group : 5·3 ( SE 0·1 ) v. 5·6 ( SE 0·2 ) mmol/l before and after overfeeding , respectively , P < 0·05 ) , whereas fasting serum insulin concentrations were maintained in both groups . Glucose AUC values increased by 10 % ( from 817 ( SE 45 ) to 899 ( SE 39 ) mmol/l per 120 min , P < 0·05 ) and whole-body insulin sensitivity decreased by 27 % ( from 5·3 ( SE 1·4 ) to 3·9 ( SE 0·9 ) , P < 0·05 ) in the control group , whereas normal insulin sensitivity was maintained in the probiotic group ( 4·4 ( SE 0·8 ) and 4·5 ( SE 0·9 ) before and after overeating , respectively ( P>0·05 ) . These results suggest that probiotic supplementation may be useful in the prevention of diet-induced metabolic diseases such as type 2 diabetes Metformin is widely used in the treatment of type 2 diabetes ( T2D ) , but its mechanism of action is poorly defined . Recent evidence implicates the gut microbiota as a site of metformin action . In a double-blind study , we r and omized individuals with treatment-naive T2D to placebo or metformin for 4 months and showed that metformin had strong effects on the gut microbiome . These results were verified in a subset of the placebo group that switched to metformin 6 months after the start of the trial . Transfer of fecal sample s ( obtained before and 4 months after treatment ) from metformin-treated donors to germ-free mice showed that glucose tolerance was improved in mice that received metformin-altered microbiota . By directly investigating metformin – microbiota interactions in a gut simulator , we showed that metformin affected pathways with common biological functions in species from two different phyla , and many of the metformin-regulated genes in these species encoded metalloproteins or metal transporters . Our findings provide support for the notion that altered gut microbiota mediates some of metformin 's antidiabetic effects To our knowledge , no reports are available indicating the favorable effects of synbiotic bread consumption on blood lipid profiles among patients with type 2 diabetes mellitus ( T2DM ) . This study was conducted to evaluate the effects of the daily consumption of synbiotic bread on blood lipid profiles of patients with T2DM . This r and omized double-blinded controlled clinical trial was performed with 78 diabetic patients , aged 35–70 years . After a 2-week run-in period , subjects were r and omly assigned to consume either synbiotic ( n = 26 ) , probiotic ( n = 26 ) or control bread ( n = 26 ) for 8 weeks . The synbiotic bread contained viable and heat-resistant probiotic Lactobacillus sporogenes ( 1 × 108 CFU ) and 0.07 g inulin ( HPX ) as prebiotic per 1 g. The probiotic bread contained L. sporogenes ( 1 × 108 CFU ) per 1 g. Patients were asked to consume the synbiotic , probiotic and control breads three times a day in a 40 g package for a total of 120 g/day . Biochemical measurements including blood lipid profiles were conducted before and after 8 weeks of intervention . Consumption of the synbiotic bread , compared to the probiotic and control breads , led to a significant decrease in serum TAG ( P = 0.005 ) , VLDL-C ( P = 0.005 ) , TC/HDL-C ( P = 0.002 ) and a significant increase in serum HDL-C levels ( P = 0.01 ) . No significant effect of synbiotic bread consumption on FPG , TC , LDL-C and non-HDL-C levels was seen compared to the probiotic and control breads ( P > 0.05 ) . Trial registry code : http://www.i rct .ir I RCT 201311215623N13 Objective To investigate the functional effects of probiotic treatment on the gut microbiota , as well as liver and adipose gene expression in diet-induced obese mice . Design Male C57BL/6J mice were fed a high-fat diet ( HFD ) for 8 weeks to induce obesity , and then r and omized to receive HFD+probiotic ( Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 , n = 9 ) or HFD+placebo ( n = 9 ) for another 10 weeks . Normal diet ( ND ) fed mice ( n = 9 ) served as non-obese controls . Results Diet-induced obese mice treated with probiotics showed reduced body weight gain and fat accumulation as well as lowered plasma insulin , leptin , total-cholesterol and liver toxicity biomarkers . A total of 151,061 pyrosequencing reads for fecal microbiota were analyzed with a mean of 6,564 , 5,274 and 4,464 reads for the ND , HFD+placebo and HFD+probiotic groups , respectively . Gut microbiota species were shared among the experimental groups despite the different diets and treatments . The diversity of the gut microbi
Output:
| Among the commonly reported findings , the genera of Bifidobacterium , Bacteroides , Faecalibacterium , Akkermansia and Roseburia were negatively associated with T2D , while the genera of Ruminococcus , Fusobacterium , and Blautia were positively associated with T2D . |
MS213510 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : The optimal graft choice of anterior cruciate ligament ( ACL ) reconstruction remains controversial . Purpose : To compare the outcomes , especially the long-term cumulative failure rate , of ACL reconstruction using either synthetics with remnant preservation or hamstring autografts ( 4-str and semitendinosus and gracilis tendons ) . Study Design : Cohort study ; Level of evidence , 2 . Methods : A total of 133 patients who underwent ACL reconstruction ( synthetics : n = 43 ; hamstring autografts : n = 90 ) between July 2004 and December 2007 were included . Question naires ( Tegner activity scale , Lysholm knee scale , and International Knee Documentation Committee [ IKDC ] subjective form ) were completed preoperatively and at 6 months , 1 year , 5 years , and 10 years postoperatively . The Knee injury and Osteoarthritis Outcome Score ( KOOS ) was additionally applied at 10 years ’ follow-up . The physical examination was based on the 2000 IKDC form . The manual maximum side-to-side difference ( KT-1000 arthrometer ) , single-hop test , thigh muscle atrophy , and joint degeneration ( Kellgren and Lawrence classification ) were evaluated . The Kaplan-Meier curve and log-rank test ( Mantel-Cox , 95 % CI ) were used to compare graft survivorship . Results : Ten years postoperatively , 111 patients were available , with 38 ( 88.4 % ) patients ( mean age , 27.6 ± 9.3 years ; 28 men ) with synthetics and 73 ( 81.1 % ) patients ( mean age , 28.6 ± 8.8 years ; 64 men ) with hamstring autografts . Among them , 104 patients ( synthetics : n = 35 [ 81.4 % ] ; hamstring autografts : n = 69 [ 76.7 % ] ) completed subjective evaluations , and 89 patients ( synthetics : n = 30 [ 69.8 % ] ; hamstring autografts : n = 59 [ 65.6 % ] ) completed objective evaluations . For hamstring autografts and synthetics , the cumulative failure rates were 8.2 % and 7.9 % , respectively , and the log-rank test demonstrated no significant difference between the 2 Kaplan-Meier survival curves ( P = .910 ) . At 6 months postoperatively , for hamstring autografts and synthetics , the mean Lysholm score was 83.0 ± 7.8 and 88.1 ± 7.5 , respectively ( P < .001 ) ; the mean IKDC score was 83.8 ± 7.8 and 86.9 ± 4.5 , respectively ( P = .036 ) ; and the mean Tegner score was 3.7 ± 1.1 and 5.0 ± 1.5 , respectively ( P < .001 ) . At 1 year postoperatively , the mean Tegner score was 5.5 ± 1.9 and 6.5 ± 2.0 , respectively ( P = .011 ) . No statistically significant difference was observed on other subjective evaluation findings , physical examination findings ( overall IKDC grade A : 45.8 % of hamstring autografts , 50.0 % of synthetics ) , side-to-side difference ( 1.5 ± 1.5 mm for synthetics , 2.4 ± 2.1 mm for hamstring autografts ) , single-hop test findings ( grade A : 84.7 % of hamstring autografts , 93.3 % of synthetics ) , grade A/B thigh muscle atrophy ( 88.1 % of hamstring autografts , 93.3 % of synthetics ) , ipsilateral radiographic osteoarthritis ( 55.9 % of hamstring autografts , 50.0 % of synthetics ) , and graft survivorship . Conclusion : In this prospect i ve cohort study , primary ACL reconstruction using either synthetics with remnant preservation or hamstring autografts showed satisfactory outcomes , especially the long-term cumulative failure rate , at 10 years postoperatively . Patient-reported outcomes suggested that symptom relief and restoration of function might occur earlier in those with synthetics Background Injury to the anterior cruciate ligament ( ACL ) of the knee is common . Following complete rupture of the ACL , insufficient re-vascularization of the ligament prevents it from healing completely , creating a need for reconstruction . A variety of grafts are available for use in ACL reconstruction surgery , including synthetic grafts . Over the last two decades new types of synthetic ligaments have been developed . One of these synthetic ligaments , the Ligament Advanced Reinforcement System ( LARS ) , has recently gained popularity . The aim of this systematic review was to assess the current best available evidence for the effectiveness of the LARS as a surgical option for symptomatic , anterior cruciate ligament rupture in terms of graft stability , rehabilitation time and return to pre-injury function . Method This systematic review included studies using subjects with symptomatic , ACL ruptures undergoing LARS reconstruction . A range of electronic data bases were search ed in May 2010 . The method ological quality of studies was appraised with a modified version of the Law critical appraisal tool . Data relating to study characteristics , surgical times , complication rates , outcomes related to knee stability , quality of life , function , and return to sport as well as details of rehabilitation programs and timeframes were collected . Results This review identified four studies of various design s , of a moderate method ological quality . Only one case of knee synovitis was reported . Patient satisfaction with LARS was high . Graft stability outcomes were found to be inconsistent both at post operative and at follow up periods . The time frames of rehabilitation periods were poorly reported and at times omitted . Return to pre-injury function and activity was often discussed but not reported in results . Conclusions There is an emerging body of evidence for LARS with comparable complication rates to traditional surgical techniques , and high patient satisfaction scores . However , this systematic review has highlighted several important gaps in the existing literature that require future prospect i ve investigation . The findings of this review were equivocal with regards to other measures such as graft stability and long term functional outcomes . While the importance of rehabilitation following LARS is well recognised , there is limited evidence to guide rehabilitation protocol We have undertaken a r and omised clinical trial comparing two methods of reconstruction of the anterior cruciate ligament in patients with chronic instability . We used an ipsilateral bone-patellar-tendon-bone autograft in 27 patients and the Ligament Advancement Reinforcement System ( LARS ) artificial ligament in 26 . Assessment before and at two , six , 12 and 24 months after surgery , included the history , physical examination , a modified International Knee Documentation Committee ( IKDC ) score , the Tegner score , the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) and instrumented laxity testing . There were no cases of reactive synovitis or of infection of the knee , and there was no difference regarding the failure rate between the two groups . The IKDC showed no significant differences between the two groups at any stage of the follow-up . The KOOS evaluation showed consistently better results in all subscales for the LARS group during the first year of follow-up . After 24 months these differences were no longer evident . Instrument-tested laxity was greater in the LARS group at all stages of follow-up , but the differences were not significant at 24 months . Our findings suggest that at follow-up at 24 months the LARS ligament seems to be a satisfactory treatment option , especially when an early return to high levels of activity is dem and ed Purpose Several studies compare the short- and long-term results of anterior cruciate ligament ( ACL ) reconstruction using bone-patellar tendon-bone ( BPTB ) graft or double-looped semitendinosus and gracilis ( DLSG ) graft . However , no studies evaluate the long-term results of BPTB grafts fixed with metal interference screws and DLSG grafts fixed with the Bone Mulch Screw and the Washer Loc . This prospect i ve r and omized multicentre study has the null hypothesis that there is no difference in long-term outcome between the two procedures . Methods A total of 114 patients with a symptomatic ACL rupture were r and omized to reconstruction with either a BPTB graft ( N = 58 ) or a DLSG graft ( N = 56 ) . Follow-up was conducted after one , two and seven years . At the seven-year follow-up , 102 of the 114 patients ( 89 % ) were available for evaluation ; however , 16 of these by telephone-interview only . Results Ten patients in the BPTB group and 19 patients in the DLSG group underwent additional knee surgery ( P = 0.048 ) , two and three , respectively , of these were ACL revisions ( n.s . ) . The total flexion work was lower in the DLSG group ( P = 0.001 ) . The mean peak flexion torque and extension work , however , showed no difference between the groups . No significant differences were found between the groups regarding the Tegner activity score , the Lysholm functional score , the Knee injury and osteoarthritis outcome score ( KOOS ) , subjective knee function , anterior knee pain or mobility . There was no significant difference in laxity between the groups on the Lachman test or the KT-1,000 maximum manual force test . Conclusions Both grafts and fixation methods result ed in satisfactory subjective outcome and objective stability . Both these methods can therefore be considered as suitable alternatives for ACL reconstructions . Level of evidence II Background : Because of specific method ological difficulties in conducting r and omized trials , surgical research remains dependent predominantly on observational or non‐r and omized studies . Few vali date d instruments are available to determine the method ological quality of such studies either from the reader 's perspective or for the purpose of meta‐ analysis . The aim of the present study was to develop and vali date such an instrument OBJECTIVE To compare the therapeutic effect of anterior cruciate ligament ( ACL ) reconstruction by means of four-str and semitendinosus tendon autograft and ligament advanced reinforcement system ( LARS ) by arthroscopy . METHODS From July 2002 to April 2005 , 42 patients underwent ACL reconstruction by arthroscopy . Twenty-seven patients were treated by four-str and semitendinosus tendon autograft ( semitendinosus tendon autograft group ) , including 22 males and 5 females , with the age from 20 years to 52 years . Among these patients , there were 12 sports injuries , 8 traffic accidents and 7 other injuries . There were 16 cases of left knees and 11 of right knees . The pre-operation Lysholm score was 50.70 + /- 6.68 , and the course of the disease was 2 to 12 months . Other 15 patients were treated by LARS artificial ligament ( LARS group ) , including 12 males and 3 females , with the age from 17 years to 40 years . Among these patients , there were 8 sports injuries , 4 traffic accidents and 3 other injuries . There were 6 cases of left knees and 9 of right knees . The pre-operation Lysholm score was 50.20 + /- 6.22 , and the course of the disease was 3 to 12 months . There was no statistically significant difference between the two groups ( P > 0.05 ) . The ranges of motion , stability and complication of the knee were evaluated during the follow-up . RESULTS All incisions healed at the first stage . The patients in the semitendinosus tendon autograft group were followed up for 22 months to 43 months , while 18 months to 40 months in the LARS group . There were 5 patients ( 19 % ) whose tensile gap was more than 3 mm when the max tensile force text was done in the semitendinosus tendon autograft group , and 3 patients ( 20 % ) in the LARS group . The Lysholm score was 87.80 + /- 3.41 in the semitendinosus tendon autograft autograft group , and 88.90 + /- 3.30 in the LARS group . There was no statistically significant difference between the two groups ( P > 0.05 ) . The final evaluation based on the improved Lysholm classification st and ard showed the choiceness rate was 92.6 % ( 18 excellent cases , 7 good cases and 2 fair cases ) in the semitendinosus tendon autograft group , and 93.3 % ( 11 excellent cases , 3 good cases , 1 fair case ) in the LARS group . There was no statistically significant difference between the two groups ( P > 0.05 ) . The joint motion capability evaluation , according to the Tegner st and ard , showed 3 to 6 class ( with the average class of 4.93 ) in the semitendinosus tendon autograft group , and 3 to 7 class ( with the average class of 5.03 ) in the LARS group . There was no statistically significant difference ( P > 0.05 ) . The knee extension in 2 cases was 5 degrees less than the normal , and in 5 cases 5 - 10 degrees less than the normal in the semitendinosus tendon autograft group . But in all cases in the LARS group , joint motion recovered to the normal ( P < 0.05 ) . There was no sign of synovitis in both
Output:
| This systematic review comparing long‐term outcomes after cruciate ligament reconstruction with either autograft or synthetics suggests no significant differences in failure risk .
Autografts were inferior to synthetics with respect to restoring knee joint stability and patient‐reported outcome scores , and were also associated with more postoperative complications |
MS213511 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: A r and omized clinical trial design ed to compare the effectiveness of cytoxan ( CTX ) alone versus a combination consisting of CTX , vincristine ( Oncovin ) and methotrexate ( COM ) in the treatment of Burkitt 's lymphoma ( BL ) was carried out . Nineteen patients were selected at r and om to receive CTX alone while 21 received COM . The two treatment regimens were equally effective in inducing remissions , and complete response rates of 83.3 % and 84.3 % were observed for CTX- and COM-treated patients , respectively . The relapse frequencies were also equal but the pattern of relapse was clearly different . Seven out of 8 ( 87.5 % ) in the CTX group relapsed with systemic and central nervous system ( CNS ) tumor , while 8 out of 10 ( 80 % ) in the COM group relapsed with CNS disease only . This difference is highly significant p = 0.008 . The remission duration s and survival to date are the same The combination of cyclophosphamide , doxorubicin , vincristine , and prednisone , given every 3 weeks ( CHOP-21 ) is st and ard chemotherapy for aggressive lymphomas . To determine whether CHOP given every 2 weeks ( CHOP-14 ) or the addition of etoposide ( CHOEP-21 , CHOEP-14 ) can improve results in patients ages 18 to 60 years with good prognosis ( normal lactic dehydrogenase [ LDH ] level ) , 710 patients were r and omized to 6 cycles of CHOP-21 , CHOP-14 , CHOEP-21 ( CHOP plus etoposide 100 mg/m2 days 1 - 3 ) , or CHOEP-14 in a 2 x 2 factorial study design . Patients in the biweekly regimens received granulocyte colony-stimulating factor ( G-CSF ) starting from day 4 . Patients received radiotherapy ( 36 Gy ) to sites of initial bulky disease and extranodal disease . CHOEP achieved better complete remission ( 87.6 % versus 79.4 % ; P = .003 ) and 5-year event-free survival rates ( 69.2 % versus 57.6 % ; P = .004 , primary end point ) than CHOP , whereas interval reduction improved overall survival ( P = .05 ; P = .044 in the multivariate analysis ) . Although the CHOEP regimens induced more myelosuppression , all regimens were well tolerated . CHOEP should be the preferred chemotherapy regimen for young patients with good-prognosis ( normal LDH level ) aggressive lymphoma The surface Ig on each B-cell lymphoma has unique portions ( idiotypes ) , which can be recognized by the immune system . In this study , we immunized patients against the Ig expressed by their tumor and observed their clinical outcomes . After st and ard chemotherapy , 41 patients with non-Hodgkin 's B-cell lymphoma received a series of injections with a vaccine consisting of tumor Ig protein coupled to keyhole limpet hemocyanin and emulsified in an immunologic adjuvant . Subjects were observed for toxicity , immune responses , and tumor status . The median duration of follow-up of all patients is 7.3 years from diagnosis and 5.3 years from the last chemotherapy given before vaccine treatment . Twenty patients ( 49 % ) generated specific immune responses against the idiotypes of their tumor Ig . Two patients who had residual disease experienced complete tumor regression in association with the development of these immune responses . The median duration of freedom from disease progression and overall survival of all 20 patients mounting an anti-idiotype immune response are significantly prolonged compared to the patients who did not mount an immune response . Thirty-two patients were in their first remission and nine were in subsequent remissions before beginning vaccine treatments . Analysis of the 32 first remission patients also shows an improved clinical outcome for those patients who mounted a specific immune response compared to those who did not ( freedom from progression , 7.9 years v 1.3 years P = .0001 ; median survival from time of last chemotherapy not yet reached v 7 years , P = .04 ) . This study confirms an earlier report that patients with B-cell lymphoma can be induced to make a specific immune response against the Ig expressed by their own tumor . It further shows that the ability to make such an immune response is correlated with a more favorable clinical outcome . Prospect i ve controlled trials will be needed to prove a causal relationship between anti-idiotype immunity and improved clinical outcome BACKGROUND The Pediatric Oncology Group ( POG ) conducted a two-arm , r and omized study for the treatment of children and adolescents with stage III small , non-cleaved cell lymphoma ( SNCCL ) . Regimen A , based on the group 's previous best treatment for this group of patients , included cyclophosphamide ( CTX ) and high-dose methotrexate ( MTX ) , as well as vincristine ( VCR ) , prednisone ( PRED ) , and intrathecal ( IT ) chemoprophylaxis . Regimen B , based on a single institution pilot study ( Total B therapy ) , consisted of two rapidly alternating chemotherapy combinations ( CTX , VCR , doxorubicin ; MTX , and cytarabine ( Ara-C ) plus coordinated IT chemotherapy . PROCEDURE One hundred thirty-four consecutive patients were entered on this study . Seventy patients were r and omized to Regimen A , and 64 patients to Regimen B. One hundred and twenty-two patients are eligible for response . RESULTS Complete remission ( CR ) was achieved by 81 % ( 52/64 ) of patients on Regimen A , and 95 % ( 55/58 ) of patients on Regimen B ( p=0.014 one-sided ) . The two-year event-free survival ( EFS ) is 64 % ( SE=6 % ) on Regimen A , and 79 % ( SE=6 % ) on Regimen B ( p=0.027 by one-sided logrank test ) . No patient has relapsed on either regimen after a year from diagnosis , although one patient had a second malignancy at day 371 . Severe , but manageable , hematologic toxicity was seen in the majority of patients on both regimens , but was more frequent on Regimen B. CONCLUSIONS We conclude that the cure rate in stage III SNCCL is significantly improved with the use of a short , six-month chemotherapy regimen of fractionated CTX alternated with coordinated MTX and Ara-C. Results suggest that drug schedule , not simple drug selection , influences outcome Twenty-two patients with Burkitt 's lymphoma in complete remission induced by either cyclophosphamide or a combination of cyclophosphamide , oncovin and methotrexate were r and omized to receive or not to receive prophylactic cerebrospinal irradiation . Six of 11 irradiated patients relapsed with tumour of the central nervous system as compared to 4 of 11 controls . Relapse frequency appeared to be related to stage of disease on admission . It is concluded that irradiation does not prevent relapse 39 patients with marginal zone B cell lymphoma ( MZBCL ) of the parotid gl and s ( stages I or II ) were studied . They were r and omized to be treated with either radiotherapy alone ( extended fields , 4500 cGy ) or radiotherapy ( the same schedule ) plus adjuvant chemotherapy ( cyclophosphamide , vincristine and prednisone ) . The end points were survival and time to treatment failure ( TTF ) . Patients who received radiotherapy alone had a complete remission rate of 100 % , the TTF was 90 % at 5 years and overall survival at 5 years was 90 % with no statistical difference when compared with patients who received combined therapy [ 100 , 80 and 95 % , respectively ( P = 0.5 ) ] . Although adjuvant chemotherapy was well tolerated , the use of this therapeutic approach in patients with early stage MZBCL did not offer any advantage over radiotherapy alone as the initial treatment . Until now , radiotherapy was considered the treatment of choice in this clinical setting of patients Twenty-seven children with abdominal Burkitt 's lymphoma ( stage III ) , who had achieved complete remission , were entered into a prospect i ve controlled trial of adjunct treatment with Epstein-Barr virus (EBV)-specific transfer factor ( TF ) . Two patients treated with TF and 2 controls relapsed early ( less than or equal to 12 weeks ) . Two out of 12 TF-treated patients and 5 out of 11 controls subsequently suffered relapses . Time to first late relapse was longer among TF-treated patients ( p = 0.08 ) , and no late relapse occurred while a patient was receiving TF treatment . Thus it seems that specific TF might be useful in the management of endemic Burkitt 's lymphoma and also in the treatment of other virus-associated cancers and diseases We report the up date d results of an intensive treatment protocol for children ( < 18 years ) and adults ( > or = 18 years ) with advanced B-cell lymphomas . The protocol consists of two chemotherapy regimens : A , consisting of cyclophosphamide , doxorubicin , vincristine and high-dose methotrexate ( CODOX-M ) , and B , consisting of ifosfamide , etoposide , and high-dose cytarabine ( IVAC ) . Both cycles included intrathecal chemotherapy ( cytarabine or methotrexate ) . Patients received a total of four cycles in the following sequence : A , B , A , B. Sixty-six previously untreated patients , enrolled before October 1996 , were included in the present analysis . Of these , 55 had Burkitt 's or Burkitt's-like lymphoma and 11 had diffuse large B-cell lymphoma . There were 53 males ad 13 females ; 40 were children and 26 were adults ( age range , 3 to 57 years ) . To date , 61 patients have achieved a complete response to therapy . Two patients subsequently relapsed , but one of these is a long-term survivor after further therapy and a bone marrow transplant . The event-free survival rate is 85 % at I year and beyond . The median potential follow-up period is 48 months ( range , 12 to 96 months ) for patients remaining in complete remission . Neutropenia occurred in 98 % of cycles and infection in 46 % of A cycles and 50 % of B cycles , but the duration was shortened in B cycles by the administration of granulocyte colony-stimulating factor . Positive blood cultures were observed in 21 % of A cycles and 28 % of B cycles , and there have been three toxic deaths . These results are better than those achieved with an earlier version of CODOX-M , suggesting that the addition of the IVAC regimen is responsible for the improved results . The similarity of the outcome in children and adults , however , confirms our previous observation that , at least in adults younger than 60 years with Burkitt 's or Burkitt's-like lymphomas , treatment with regimens similar to those used in children is warranted Thirty patients with human immunodeficiency virus (HIV)-associated non-Hodgkin 's lymphoma ( NHL ) receiving chemotherapy with cyclophosphamide , doxorubicin , vincristine , and prednisone ( CHOP ) were r and omized to receive either subcutaneous recombinant human granulocyte-macrophage colony-stimulating factor ( rGM-CSF ) or no additional therapy . Recombinant rGM-CSF ( at a dose of 10 - 20 micrograms/kg/d ) was given on days 1 to 10 ( early rGM-CSF ) to the first five patients , but was changed to days 4 to 13 ( delayed rGM-CSF ) of each chemotherapy cycle in subsequent patients . Compared with the control group ( N = 10 ) , the delayed rGM-CSF group ( N = 11 ) had higher mean nadirs of the absolute neutrophil count ( 0.36 v 0.89 x 10(9)/L ; P = .009 ) , shorter mean duration s of neutropenia ( 4.9 v 1.3 days ; P = .02 ) , fewer chemotherapy cycles complicated by neutropenia and fever ( 67 % v 27 % ; P = .001 ) , fewer days hospitalized for fever and neutropenia ( 4.9 v 1.8 ; P = .004 ) , fewer reductions in chemotherapy dosages , and less frequent delays in chemotherapy administration . No significant differences were observed between patients in the control group and those in the early rGM-CSF group ( N = 5 ) . Median levels of serum HIV-1 p24 antigen decreased to 18 % and 17 % of baseline values in control ( N = 4 ) and rGM-CSF groups ( N = 6 ) , respectively , 1 week following administration of the first cycle of chemotherapy . In the third week after chemotherapy , median antigen levels remained below baseline in the control group , but rose to 243 % of baseline values in the rGM-CSF group ( P = .01 ) , suggesting stimulation of HIV replication . The effect of this change in HIV activity on clinical outcome of treated patients could not be determined , and therefore the clinical significance of this finding remains unclear . Complete response rates of 67 % , 70 % , and 60 % were observed in the control , delayed rGM-CSF , and early rGM-CSF groups , respectively , with corresponding survival times of 9.0 , 11.4 , and 8.0 months The B-cell antigen CD20 is expressed on normal B cells and by nearly all B-cell lymphomas . This nonmodulating
Output:
| This review does not currently provide any strong evidence on the relative effectiveness of interventions to treat Burkitt 's lymphoma . |
MS213512 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Obesity has become a global public health problem , which also affects children . It has been proposed that the educational interventions during childhood could be a key strategy in the prevention of obesity . Objective To evaluate the efficacy of an intervention on food habits and physical activity in school children . Methods A 2-year cluster-r and omised prospect i ve study with two parallel arms was used to evaluate an intervention programme in children in their first year of primary schooling ( 5–6 years of age ) in schools in the city of Granollers . The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation , Vision , Action and Change ( IVAC ) . At the beginning and at the end of the study ( 2006 and 2008 ) the weight and height of each child was measured in situ , while the families were given a self-report physical activity question naire and the Krece Plus quick test . Results Two years after the beginning of the study , the body mass index of the children in the control group was 0.89 kg/m2 higher than that of the intervention schools . The intervention reduced by 62 % the prevalence of overweight children . Similarly , the proportion of children that ate a second piece of fruit and took part in an after-school physical activity increased in the intervention group . In the control group , the weekly consumption of fish was reduced . Conclusions The educational intervention in healthy eating habits and physical activity in the school could contribute to lessen the current increase in child obesity The current review aim ed to systematic ally identify dietary , physical activity and sedentary behaviours in preschool children ( 4 - 6 years of age ) that are prospect ively related to overweight or obesity later in childhood . Prospect i ve studies published between January 1990 and June 2010 were selected from search es in PubMed , EMBASE , PsycINFO , CINAHL and Cochrane Library . Studies examining the prospect i ve association between at least one relevant behaviour measured during preschool period ( children aged 4 - 6 years at baseline ) in relation to at least one anthropometric measurement at follow-up ( age < 18 years ) were included . Harvest plots were used to summarize the results and draw conclusions from the evidence . Of the 8,718 retrieved papers , 23 papers reporting on 15 different study sample s were included in this review . Strong evidence was found for an inverse association between total physical activity and overweight . Moderate evidence was observed for a positive association between television viewing and overweight . Because of the heterogeneity in the assessed dietary behaviours , insufficient evidence was found for an association between dietary intake or specific dietary behaviours and overweight . These results suggest that interventions aim ing to prevent overweight among preschool children should focus on promotion of total physical activity and limitation of screen time and that further research is needed to establish whether and which dietary behaviours are important for obesity prevention in this age group . However , despite the lack of evidence for dietary behaviours from the present review , future interventions may already target specific dietary behaviours that are highly prevalent and for which there a clear rationale as well as preliminary evidence that these behaviours are associated with overweight OBJECTIVE The purpose of the present study was to evaluate the effects of a school-based , 2-year , multi-component intervention on BMI , eating and physical activity behaviour in Fl and ers , Belgium , targeting children aged 3 - 6 years in communities of high and low socio-economic status ( SES ) . DESIGN Cluster-r and omized controlled trial . SETTING Thirty-one pre- primary and primary schools in three different intervention communities and three paired-matched ( on SES profile ) control communities in Fl and ers , Belgium . SUBJECTS BMI Z-scores at baseline and follow-up were calculated for 1102 children . Question naires with sociodemographic data and FFQ were available from 694 of these 1102 children . RESULTS No significant effects were found on BMI Z-scores for the total sample . However , there was a significant decrease in BMI Z-score of 0·11 in the low-SES intervention community compared with the low-SES control community , where the BMI Z-score increased by 0·04 ( F = 6·26 , P = 0·01 ) . No significant intervention effects could be found for eating behaviour , physical activity or screen-time . There were no significant interaction effects of age and gender of the children on the outcome variables . CONCLUSIONS Although no significant effects were found for BMI Z-scores in the total sample , this intervention had a promising effect in the low-SES community of reducing excess weight gain among young children Background The aim of these review s is to inform the design and content of interventions to reduce obesity in young children . The behaviors that are associated with obesity/overweight have been studied extensively ; however , the factors associated with these behaviors in young children ( 0 to 6 years ) have not been systematic ally review ed . Over the past few years the focus of obesity prevention has shifted to preschool children because of the high prevalence of obesity at school entry and recognition that habits formed in early life could track into adulthood . In order to develop effective interventions and change behavior , it is important to underst and the factors that are associated with those behaviors . For example , we need to underst and whether it would be more important to target the family , childcare setting s or the wider environment and identify the most effective way of changing these energy balance related behaviors . Methods / Design Quantitative ( intervention and observational ) and qualitative literature on determinants/correlates of fruit and vegetable intake , sugar sweetened beverage and other unhealthy diet intake , and physical activity and sedentary behaviors in young children will be systematic ally identified , mapped and review ed . A common search strategy ( no language or period restrictions ) will be used to identify papers from eight electronic data bases and this will be supplemented by h and - search ing . Next , studies in developed countries that examine the factors associated with these behaviors in children aged 0 to 6 years ( at baseline ) will be screened and mapped descriptively followed by in-depth data extraction , quality assessment and synthesis . Data from quantitative studies will be summarized using either forest plots or harvest plots and narrative synthesis , and qualitative studies using thematic analysis . Qualitative evidence will be integrated with the quantitative evidence , using a parallel synthesis approach , to provide a deeper underst and ing of effective strategies to influence these energy balance related behaviors . Discussion In addition to updating and mapping current research , these review s will be the first to comprehensively synthesize and integrate both the quantitative and qualitative evidence pertaining to determinants/correlates/barriers/facilitators of obesity related behaviors in this young age group ( 0 to 6 years ) with the aim of informing future interventions . Systematic review registration International Prospect i ve Register for Systematic Review s ( PROSPERO ) Registration number : BACKGROUND Increased intake of sugar-sweetened beverages and fruit juice has been associated with overweight in children . OBJECTIVE This study prospect ively assessed beverage consumption patterns and their relationship with weight status in a cohort of children born at different risk for obesity . METHODS AND PROCEDURES Participants were children born at low risk ( n = 27 ) or high risk ( n = 22 ) for obesity based on maternal prepregnancy BMI ( kg/m(2 ) ) . Daily beverage consumption was generated from 3-day food records from children aged 3 - 6 years and coded into seven beverage categories ( milk , fruit juice , fruit drinks , caloric and non-caloric soda , soft drinks including and excluding fruit juice ) . Child anthropometric measures were assessed yearly . RESULTS High-risk children consumed a greater percentage of daily calories from beverages at age 3 , more fruit juice at ages 3 and 4 , more soft drinks ( including fruit juice ) at ages 3 - 5 , and more soda at age 6 compared to low-risk children . Longitudinal analyses showed that a greater 3-year increase in soda intake was associated with an increased change in waist circumference , whereas a greater increase in milk intake was associated with a reduced change in waist circumference . There was no significant association between change in intake from any of the beverage categories and change in BMI z-score across analyses . DISCUSSION Children 's familial predisposition to obesity may differentially affect their beverage consumption patterns . Future research should examine the extent to which dietary factors may play a role in pediatric body fat deposition over time Objective : To examine the types of drinks consumed by children at 18 months of age , determine any associations with socio-demographic characteristics and investigate the use of a bottle for providing these drinks . Design : A total of 1026 r and omly chosen children from the Avon Longitudinal Study of Pregnancy and Childhood ( ALSPAC ) were studied . Methods : As part of a dietary diary completed when their children were 18 months of age , mothers were asked to record all drinks consumed over a 24 h period and to report the containers used to give these drinks . Socio-demographic characteristics were obtained via self-completion question naire . Results : Dietary records were available for 1026 children at 18 months . A wide variety of drinks were given at this age . In all , 64 % of children had received at least one drink in a bottle and 10 % solely used a bottle . Bottle users consumed a significantly greater volume of milk drinks compared to those who used a cup or other container . The types of drinks consumed and adherence to the guidelines on weaning were associated with several socio-demographic characteristics . In particular , children with mothers of lower educational level were more likely to receive fizzy drinks and low-calorie soft drinks , more likely to drink from a bottle , and less likely to drink from a cup . Conclusion : We have shown that certain groups of mothers with 18-month-old children are not following the current guidelines on weaning . Assuming these guidelines have scientific validity , it is clear that nutritional education needs to be targeted at these mothers to help them feed their children in the optimal way , to protect from nutritional deficiencies , possible later obesity and poor dental health . Sponsorship : University of Bristol OBJECTIVE To assess the prevalence of breastfeeding and formula feeding , the age of introduction to specific foods , and the types of foods and beverages consumed by Hispanic infants and toddlers compared with similarly aged non-Hispanic infants and toddlers living in the United States . DESIGN Descriptive and comparative analysis of dietary recall data and responses to specific interview questions , which were collected in the 2002 Feeding Infants and Toddlers Study . Breastfeeding status , timing of introduction of complementary foods , percentage consuming foods from specific food groups , and the most frequently consumed fruits and vegetables by Hispanic and non-Hispanic children by age group ( 4 - 5 months , 6 - 11 months , 12 - 24 months ) . SUBJECTS A national r and om sample of 371 Hispanic and 2,637 non-Hispanic infants and toddlers between the ages of 4 and 24 months . STATISTICAL ANALYSIS To test for differences between Hispanic and non-Hispanic children in the percentage who consumed a particular food item , we calculated percentages and st and ard errors in SUDAAN and 95 % and 99 % confidence intervals . The most frequently consumed fruits and vegetables were determined by tallying the percentage of infants and toddlers who consumed each specific fruit or vegetable on a given day . RESULTS Although there were some similarities , the early flavor and food experiences of Hispanic infants were different from similarly aged non-Hispanic infants in several ways . Hispanic infants younger than 1 year of age were more likely to have ever been breastfed and those who were 4 to 5 months were more likely than non-Hispanics to be eating pureed baby foods on a daily basis . Although less likely to be eating non-infant cereals and baby food vegetables , 6- to 11-month-old Hispanics were more likely to be eating fresh fruits , fruit-flavored drinks , baby cookies , and foods such as soups , rice , and beans that are common in many Hispanic cultures . When fruits were introduced into the Hispanic child 's diet , they were most commonly consumed fresh . This higher prevalence of being fed soups , rice , beans , and sweetened fruit-flavored drinks as well as tortillas was also observed among the 12- to 24-month-old toddlers . CONCLUSIONS Dietetics professionals should be aware of the cultural differences in the foods fed to infants and toddlers that may contribute to the development of long-term food preferences and impact on nutrition . Underst and ing the factors that underlie food preferences is important if we are to develop evidence -based strategies to improve children 's eating habits and lower their risks factors associated with obesity and other chronic diseases Background Early childhood services have been identified as a key setting for promoting healthy eating and physical activity as a means of preventing overweight and obesity . However , there is limited evidence on effective nutrition and physical activity programs in this setting . The purpose of this study was to evaluate Munch and Move , a low-intensity , state-wide , professional development program design ed to support early childhood professionals to promote healthy eating and physical activity among children in their care . Methods The evaluation involved 15 intervention and 14 control preschools ( n = 430 ; mean age 4.4 years ) in Sydney , New South Wales , Australia and was based on a r and omised-control design with pre and post evaluation of children 's lunchbox contents , fundamental movement skills ( FMS ) , preschool policies and practice s and staff attitudes , knowledge and confidence related to physical activity , healthy eating and recreational screen time . Results At follow up , FMS scores for locomotor , object control and total FMS score significantly improved by 3.4 , 2.1 and 5.5 points more ( respectively ) in the intervention group compared with the control group ( P < 0.001 ) and the number of FMS sessions per week increased by 1.5 ( P = 0.
Output:
| There is consistent evidence to support potentially modifiable correlates/determinants of SSB consumption in young children acting at parental ( modelling ) , child ( TV viewing ) and environmental ( school policy ) levels |
MS213513 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objectives Construct an ethnic-specific chart and compare the prediction of adverse outcomes using this chart with the clinical ly recommended UK-WHO and customised birth weight charts using cut-offs for small-for-gestational age ( SGA : birth weight < 10th centile ) and large-for-gestational age ( LGA : birth weight > 90th centile ) . Design Prospect i ve cohort study . Setting Born in Bradford ( BiB ) study , UK . Participants 3980 White British and 4448 Pakistani infants with complete data for gestational age , birth weight , ethnicity , maternal height , weight and parity . Main outcome measures Prevalence of SGA and LGA , using the three charts and indicators of diagnostic utility ( sensitivity , specificity and area under the receiver operating characteristic ( AUROC ) ) of these chart-specific cut-offs to predict delivery and neonatal outcomes and a composite outcome . Results In White British and Pakistani infants , the prevalence of SGA and LGA differed depending on the chart used . Increased risk of SGA was observed when using the UK-WHO and customised charts as opposed to the ethnic-specific chart , while the opposite was apparent when classifying LGA infants . However , the predictive utility of all three charts to identify adverse clinical outcomes was poor , with only the prediction of shoulder dystocia achieving an AUROC>0.62 on all three charts . Conclusions Despite being recommended in national clinical guidelines , the UK-WHO and customised birth weight charts perform poorly at identifying infants at risk of adverse neonatal outcomes . Being small or large may increase the risk of an adverse outcome ; however , size alone is not sensitive or specific enough with current detection to be useful . However , a significant amount of missing data for some of the outcomes may have limited the power needed to determine true associations OBJECTIVE : To demonstrate that individualized optimal fetal growth norms , accounting for physiologic and pathologic determinants of fetal growth , better identify normal and abnormal outcomes of pregnancy than existing methods . METHODS : In a prospect i ve cohort of 38,033 singleton pregnancies , we identified 9,818 women with a completely normal outcome of pregnancy and characterized the physiologic factors affecting birth weight using multivariable regression . We used those physiologic factors to individually predict optimal growth trajectory and its variation , growth potential , for each fetus in the entire cohort . By comparing actual birth weight with growth potential , population , ultrasound , and customized norms , we calculated for each fetus achieved percentiles , by each norm . We then compared proportions of pregnancies classified as normally grown , between 10th and 90th percentile , or aberrantly grown , outside this interval , by growth potential and traditional norms , in 14,229 complicated pregnancies , 1,518 pregnancies with diabetes or hypertensive disorders , and 1,347 pregnancies with neonatal complications . RESULTS : Nineteen physiologic factors , associated with maternal characteristics and early placental function , were identified . Growth potential norms correctly classified significantly more pregnancies than population , ultrasound , or customized norms in complicated pregnancies ( 26.4 % compared with 18.3 % , 18.7 % , 22.8 % , respectively , all P<.05 ) , pregnancies with diabetes or hypertensive disorders ( 37.3 % compared with 23.0 % , 28.0 % , 34.0 % , respectively , all P<.05 ) and neonatal complications ( 33.3 % compared with 19.7 % , 24.9 % , 29.8 % , respectively , all P<.05 ) . CONCLUSION : Growth potential norms based on the physiologic determinants of birth weight are a better discriminator of aberrations of fetal growth than traditional norms . LEVEL OF EVIDENCE : BACKGROUND In 2006 , WHO produced international growth st and ards for infants and children up to age 5 years on the basis of recommendations from a WHO expert committee . Using the same methods and conceptual approach , the Fetal Growth Longitudinal Study ( FGLS ) , part of the INTERGROWTH-21(st ) Project , aim ed to develop international growth and size st and ards for fetuses . METHODS The multicentre , population -based FGLS assessed fetal growth in geographically defined urban population s in eight countries , in which most of the health and nutritional needs of mothers were met and adequate antenatal care was provided . We used ultrasound to take fetal anthropometric measurements prospect ively from 14 weeks and 0 days of gestation until birth in a cohort of women with adequate health and nutritional status who were at low risk of intrauterine growth restriction . All women had a reliable estimate of gestational age confirmed by ultrasound measurement of fetal crown-rump length in the first trimester . The five primary ultrasound measures of fetal growth -- head circumference , biparietal diameter , occipitofrontal diameter , abdominal circumference , and femur length -- were obtained every 5 weeks ( within 1 week either side ) from 14 weeks to 42 weeks of gestation . The best fitting curves for the five measures were selected using second-degree fractional polynomials and further modelled in a multilevel framework to account for the longitudinal design of the study . FINDINGS We screened 13,108 women commencing antenatal care at less than 14 weeks and 0 days of gestation , of whom 4607 ( 35 % ) were eligible . 4321 ( 94 % ) eligible women had pregnancies without major complications and delivered live singletons without congenital malformations ( the analysis population ) . We documented very low maternal and perinatal mortality and morbidity , confirming that the participants were at low risk of adverse outcomes . For each of the five fetal growth measures , the mean differences between the observed and smoothed centiles for the 3rd , 50th , and 97th centiles , respectively , were small : 2·25 mm ( SD 3·0 ) , 0·02 mm ( 3·0 ) , and -2·69 mm ( 3·2 ) for head circumference ; 0·83 mm ( 0·9 ) , -0·05 mm ( 0·8 ) , and -0·84 mm ( 1·0 ) for biparietal diameter ; 0·63 mm ( 1·2 ) , 0·04 mm ( 1·1 ) , and -1·05 mm ( 1·3 ) for occipitofrontal diameter ; 2·99 mm ( 3·1 ) , 0·25 mm ( 3·2 ) , and -4·22 mm ( 3·7 ) for abdominal circumference ; and 0·62 mm ( 0·8 ) , 0·03 mm ( 0·8 ) , and -0·65 mm ( 0·8 ) for femur length . We calculated the 3rd , 5th 10th , 50th , 90th , 95th and 97th centile curves according to gestational age for these ultrasound measures , representing the international st and ards for fetal growth . INTERPRETATION We recommend these international fetal growth st and ards for the clinical interpretation of routinely taken ultrasound measurements and for comparisons across population s. FUNDING Bill & Melinda Gates Foundation Objective : Compare customized versus population -based growth curves for identification of small-for-gestational-age ( SGA ) and body fat percent ( BF% ) among preterm infants . Methods : Prospect i ve cohort study of 204 preterm infants classified as SGA or appropriate-for-gestational-age ( AGA ) by population -based and customized growth curves . BF% was determined by air-displacement plethysmography . Differences between groups were compared using bivariable and multivariable linear and logistic regression analyses . Results : Customized curves reclassified 30 % of the preterm infants as SGA . SGA infants identified by customized method only had significantly lower BF% ( 13.8 ± 6.0 ) than the AGA ( 16.2 ± 6.3 , p = 0.02 ) infants and similar to the SGA infants classified by both methods ( 14.6 ± 6.7 , p = 0.51 ) . Customized growth curves were a significant predictor of BF% ( p = 0.02 ) , whereas population -based growth curves were not a significant independent predictor of BF% ( p = 0.50 ) at term corrected gestational age . Conclusion : Customized growth potential improves the differentiation of SGA infants and low BF% compared with a st and ard population -based growth curve among a cohort of preterm infants OBJECTIVES Fetal growth restriction is a strong risk factor for stillbirth . We compared the performance of three fetal growth curves - customized , ultrasound ( Hadlock ) and population - in identifying abnormally grown fetuses at risk of stillbirth . METHODS We performed a case-control study of singleton stillbirths ( delivered between 2000 and 2010 ) at one center . Four liveborn controls were r and omly identified for each stillbirth . Ultrasound-estimated fetal weight within 1 month prior to delivery was used to calculate growth percentiles for each fetus using three fetal growth norms . Sensitivities and odds ratios for stillbirth , as well as odds of abnormal growth according to formula , were calculated . RESULTS There were 49 stillbirths and 197 live births . Using the customized norms , growth of the fetuses destined to be stillborn was bimodal , with both more small-for-gestational-age ( SGA ; < 10(th ) percentile ) and large-for-gestational-age ( LGA ; ≥ 90(th ) percentile ) fetuses . Odds of being abnormally grown were significantly higher using ultrasound compared with population norms ( P = 0.02 ) but were not statistically different using ultrasound and customized norms ( P = 0.21 ) . Sensitivity for identification of SGA on ultrasound as a predictor of stillbirth was higher using customized ( 39 % ; 95 % CI , 24 - 54 % ) or ultrasound ( 33 % ; 95 % CI , 19 - 47 % ) , rather than population ( 14 % ; 95 % CI , 4 - 25 % ) , norms . CONCLUSIONS Among fetuses destined to be stillborn , customized and ultrasound norms identified a greater proportion of both SGA and LGA estimated fetal weights . The customized norms performed best in identifying death among SGA fetuses . These results should be interpreted within the limitations of the study design Accurate assessment of fetal growth status requires the definition of an optimal st and ard , which represents the growth potential of the baby . Against this st and ard , individually ' customized ' percentiles can be calculated . They improve the distinction between normal and abnormal , and help in our underst and ing and diagnosis of pathological fetal growth . This method can be used as a tool for epidemiological analysis as well as for prospect i ve clinical monitoring BACKGROUND The recently published INTERGROWTH-21st Project international population st and ard for newborn size is intended for global use , but its ability to identify small infants at risk of adverse outcomes in a general obstetric population has not been reported . OBJECTIVE The objective of the study was to compare adverse neonatal outcomes among small-for-gestational-age ( SGA ) infants between the INTERGROWTH-21st st and ard and a customized birthweight st and ard ( accounting for maternal characteristics of height , weight , parity , and ethnicity ) . We hypothesized that in a multiethnic general obstetric population in Auckl and , New Zeal and , a customized birthweight st and ard would better identify SGA infants at-risk of neonatal morbidity/mortality and stillbirth than the INTERGROWTH-21st st and ard . STUDY DESIGN Using prospect ively gathered maternity data from a general obstetric population in Auckl and , New Zeal and , from 2006 to 2013 ( n = 53,484 births at ≥ 33 weeks ) , infants were classified as SGA ( birthweight < 10th centile ) by INTERGROWTH-21st and customized st and ards . Infants were further categorized as SGA by both criteria , INTERGROWTH-21st only , customized only , or not SGA ( met neither criteria ) . Composite adverse neonatal outcome was defined as neonatal death , neonatal intensive care admission > 48 hours , or ventilation > 4 hours or 5-minute Apgar score < 7 . Relative risks for primary outcomes were estimated using modified Poisson regression , with the non-SGA group as the referent . RESULTS Incidence of SGA was 4.5 % by INTERGROWTH-21st and 11.6 % by customized st and ard . Compared with those not SGA , infants identified as small for gestational age by both criteria had the highest risk of adverse neonatal outcome ( relative risk [ RR ] , 4.1 , 95 % confidence interval [ CI ] , 3.7 - 4.6 ) and stillbirth ( RR , 8.3 , 95 % CI , 5.1 - 13.4 ) . Infants SGA by customized st and ard only ( n = 4015 ) had an increased risk of adverse neonatal outcome ( RR , 2.0 , 95 % CI , 1.8 - 2.2 ) and stillbirth ( RR , 3.0 , 95 % CI , 1.7 - 5.3 ) . Few infants were identified as SGA by INTERGROWTH-21st only ( n = 172 ) , and risks of adverse neonatal outcome and stillbirth were not increased . Findings were unchanged when analyses were
Output:
| Both customized and population -based growth charts can identify SGA neonates at risk for adverse outcomes . |
MS213514 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Sixty consecutive collegiate athletes with “ high ” ankle symptoms were prospect ively evaluated over a 3-year period in an effort to better define this debilitating ankle injury . All athletes included in this study had tenderness over the distal anterior tibiofibular ligament , tenderness proximally along the interosseous membrane , and functional disability . No study subject had a fracture or frank tibia-fibula diastasis . The severity of the sprain was quantified using the interosseous “ tenderness length . ” A st and ard rehabilitation protocol was followed by all patients . Athletes returned to competition when they could perform all functional testing without difficulty . Time to return to full competitive activity averaged 13.4 days . The number of days missed from competition was statistically related to the interosseous tenderness length ( P 0.0001 ) and to positive results on the squeeze test ( P 0.03 ) . Fifty-three of the 60 injured athletes were evaluated at least 6 months after injury . Patients rated their outcomes as good or excellent . Six of the patients experienced occasional ankle pain and stiffness , four patients reported recurrent ankle sprains , and one patient had heterotopic ossification formation Seventy-two patients with subacute or chronic rupture of the anterior cruciate ligament were r and omly assigned to autograft reconstruction with four-str and gracilis and semitendinosus tendon ( N = 37 ) or with patellar tendon-bone ( N = 35 ) from the ipsilateral side . The groups were similar in terms of age , sex , level of activity , degree of laxity , meniscal lesions found surgically , and rehabilitation program . The follow-up was performed at another hospital by independent observers after 6 , 12 , and 24 months . Sixty-one patients ( 32 with hamstring tendon grafts and 29 with patellar tendon grafts ) complied with the follow-up routine for the full 24 months . No differences were found between the groups with respect to Cincinnati functional score , KT-1000 arthrometer measurements , or stairs hopple test results . The subjective result and the single-legged hop test result were better for the hamstring tendon group after 6 and 12 months , but no differences were found after 24 months . The hamstring tendon group showed better isokinetic knee extension strength than did the patellar tendon group after 6 months , but not after 12 and 24 months . There was a significant weakness in isokinetic knee flexion strength among the hamstring tendon group . Anterior knee pain was not significantly different between the groups , but kneeling pain was significantly less common in the hamstring tendon group after 24 months In a two-centre study , 164 patients with unilateral instability of the anterior cruciate ligament were prospect ively r and omised to arthroscopic reconstruction with either a patellar tendon graft using interference screw fixation or a quadruple semitendinosus graft using an endobutton fixation technique . The same postoperative rehabilitation protocol was used for all patients and follow-up at a median of 31 months ( 24 to 59 ) was carried out by independent observers . Four patients ( 2 % ) were lost to follow-up . No significant differences were found between the groups regarding the Stryker laxity test , one-leg hop test , Tegner activity level , Lysholm score , patellofemoral pain score , International Knee Documentation Committee ( IKDC ) score or visual analogue scale , reflecting patient satisfaction and knee function . Slightly decreased extension , compared with the non-operated side , was found in the patellar tendon group ( p < 0.05 ) . Patients with associated meniscal injuries had lower IKDC , visual analogue ( p < 0.01 ) and Lysholm scores ( p < 0.05 ) than those without such injuries . Patients in whom reconstruction had been carried out less than five months after the injury had better final IKDC scores than the more chronic cases ( p < 0.05 ) . We conclude that patellar tendon and quadruple semitendinous tendon grafts have similar outcomes in the medium term . Associated meniscal pathology significantly affects the final outcome and early reconstruction seems to be beneficial The purpose of this study was to examine a young athletic population to up date the data regarding epidemiology and disability associated with ankle injuries . At the United States Military Academy , all cadets presenting with ankle injuries during a 2-month period were included in this prospect i ve observational study . The initial evaluation included an extensive question naire , physical examination , and radiographs . Ankle sprain treatment included a supervised rehabilitation program . Subjects were reevaluated at 6 weeks and 6 months with subjective assessment , physical examination , and functional testing . The mean age for all subjects was 20 years ( range , 17–24 years ) . There were 104 ankle injuries accounting for 23 % of all injuries seen . There were 96 sprains , 7 fractures , and 1 contusion . Of the 96 sprains , 4 were predominately medial injuries , 76 were lateral , and 16 were syndesmosis sprains . Ninety-five percent had returned to sports activities by 6 weeks ; however , 55 % of these subjects reported loss of function or presence of intermittent pain , and 23 % had a decrement of > 20 % in the lateral hop test when compared with the uninjured side . At 6 months , all subjects had returned to full activity ; however , 40 % reported residual symptoms and 2.5 % had a decrement of > 20 % on the lateral hop test . Neither previous injury nor ligament laxity was predictive of chronic symptomatology . Furthermore , chronic dysfunction could not be predicted by the grade of sprain ( grade I vs. II ) . The factor most predictive of residual symptoms was a syndesmosis sprain , regardless of grade . Syndesmosis sprains were most prevalent in collision sports . This study demonstrates that even though our knowledge and underst and ing of ankle sprains and rehabilitation of these injuries have progressed in the last 20 years , chronic ankle dysfunction continues to be a prevalent problem . The early return to sports occurs after almost every ankle sprain ; however , dysfunction persists in 40 % of patients for as long as 6 months after injury . Syndesmosis sprains are more common than previously thought , and this confirms that syndesmosis sprains are associated with prolonged disability Abstract A total of 41 consecutive patients ( 11 women and 30 men , median age 29 ( 18–51 ) years ) with unilateral , isolated , posttraumatic , recurrent anterior shoulder dislocation and a Bankart lesion were operatively repaired , either by an arthroscopic technique including a capsular plication , or by an open procedure with Mitec anchors . All the patients were followed prospect ively and evaluated after a median of 36 ( 30–52 ) months follow-up by a “ blind ” observer . Nineteen patients in each group had excellent or good results , and one in each group was grade d as fair . One patient in the arthroscopic group had a traumatic dislocation 5 months after the operation and was grade d as poor . Three patients experienced subluxations postoperatively , one in the arthroscopic and two in the open group . There was no significant difference in anterior-posterior shoulder laxity measured objective ly with Donjoy . The open Bankart repair group had a statistically significantly longer hospitalization ( P = 0.001 ) , a slight decrease in external range of motion , and more frequent cosmetic complaints . Apart from this , the results revealed no major differences between the two methods after a median of 36 months in this selected group of patients with longst and ing problems PURPOSE The purpose of this study was to compare the results of arthroscopic and open repair of isolated Bankart lesions of the shoulder using metallic suture anchors . TYPE OF STUDY Prospect i ve r and omized clinical study . METHODS Sixty patients with traumatic anterior shoulder instability underwent a surgical repair of an isolated Bankart lesion . The patients were divided into 2 groups of 30 patients each . In group 1 , an arthroscopic repair was performed , and in group 2 , an open procedure was performed . The groups were homogeneous for gender , age , dominance , number of dislocations , time elapsed between first dislocation and surgery , and pathologic findings . In all cases of both groups , the lesion was repaired using metallic suture anchors carrying nonabsorbable braided sutures . Postoperative rehabilitation was the same for the 2 groups . Two years ' follow-up evaluation included Constant and Rowe shoulder scores . Statistical analysis of data was performed using an unpaired t test ( significance for P < .05 ) . RESULTS No recurrence of dislocation of the involved shoulder has been reported in either group . Follow-up Constant and Rowe scores of the 2 groups were not significantly different . The only significant difference seen between the 2 groups was for range of motion evaluation with the Constant score . The mean value for group 1 ( 39.6 + /- 0.8 ) was significantly greater ( P = .017 ) than that for group 2 ( 37.8 + /- 2.0 ) . CONCLUSIONS Arthroscopic repair with suture anchors is an effective surgical technique for the treatment of an isolated Bankart lesion . Open repair does not offer a significantly better 2-year result in terms of stability , and furthermore , can negatively affect the recovery of full range of motion of the shoulder . LEVEL OF EVIDENCE Level BACKGROUND The aim of the study was to compare the results after arthroscopic anterior cruciate ligament ( ACL ) reconstruction using central -third bone-patellar tendon-bone ( BTB ) autografts and triple/quadruple semitendinosus ( ST ) autografts . HYPOTHESIS In the long-term , ACL reconstruction using BTB autografts will render more donor-site problems than ST autografts . STUDY DESIGN R and omized controlled trial ; Level of evidence , 1 . METHODS A r and omized series of 71 patients ( 22 women and 49 men ) with a unilateral ACL rupture who underwent reconstructive surgery were included in the study . The BTB graft was used in 34 patients ( BTB group ) and the ST-tendon graft was used in 37 patients ( ST group ) . The patients were examined a median of 86 months ( range , 68 to 114 months ) after the reconstruction . RESULTS Sixty-eight of 71 patients ( 96 % ) were examined at follow-up . The clinical assessment s at follow-up revealed no significant differences between the BTB group and the ST group in terms of the Lysholm score , Tegner activity level , International Knee Documentation Committee evaluation system , 1-legged hop test , KT-1000 arthrometer laxity measurements , manual Lachman test , and range of motion . A significant improvement was seen in both groups compared with the preoperative values in terms of most clinical assessment s. Donor-site morbidity in the form of knee-walking ability , kneeling ability , and area of disturbed anterior knee sensitivity revealed no significant differences between the groups . CONCLUSION Seven years after ACL reconstruction , the subjective and objective outcomes were similar after using the central -third BTB autograft and triple/quadruple ST autograft . Furthermore , no difference in terms of donor-site morbidity was found between the 2 groups PURPOSE The aim of this study was to compare the results after arthroscopic anterior cruciate ligament ( ACL ) reconstruction using central -third , bone-patellar tendon-bone ( BPTB group ) , 3-str and semitendinosus ( ST group ) , or 4-str and semitendinosus/gracilis ( ST/G group ) autografts . TYPE OF STUDY Prospect i ve r and omized trial . METHODS A r and omized series of 134 patients , all with unilateral ACL rupture was included in the study . In all 3 groups , interference screw fixation of the graft was used at both ends and 125 of 134 ( 93 % ) of the patients returned for the follow-up examination after 26 months ( range , 20 to 43 months ) . The preoperative assessment s in all 3 groups were similar in terms of gender , Tegner activity level , Lysholm score , KT-1000 measurements , 1-leg hop test , and the knee-walking test . RESULTS At follow-up , the knee-walking test was significantly worse in the BPTB group than in the ST group ( P = .0004 ) and ST/G group ( P < .0001 ) . Furthermore , the knee-walking test was significantly worse at follow-up than preoperatively in the BPTB group ( P < .0001 ) . The corresponding findings were not made in the other 2 groups . A significant reduction in knee laxity and an increase in activity level compared with the preoperative assessment s were found in all 3 groups , without any significant differences between the groups . CONCLUSIONS Two years after ACL reconstruction , the use of ST and ST/G autografts rendered significantly less discomfort during the knee-walking test than the use of BPTB autografts . However , in terms of functional outcome and knee laxity , the groups displayed no significant differences . LEVEL OF EVIDENCE Level Seventy patients with patellar tendon or hamstring tendon autografts for single-incision anterior cruciate ligament reconstruction were evaluated at least 2 years after surgery . All reconstructions were performed by the same surgeon , and metal interference screws were used for fixation of all grafts . No significant differences were noted between groups for Lysholm score , reduction in activity , KT-1000 arthrometer findings , quadriceps muscle
Output:
| In the hierarchy of medical evidence , systematic review s including meta-analyses represent the highest form of evidence if inclusion is limited to Level-I or II studies ( Table I ) . |
MS213515 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract : The purpose of this r and omized , double-masked , placebo-controlled study was to determine the efficacy and safety of risedronate in the prevention of vertebral fractures in postmenopausal women with established osteoporosis . The study was conducted at 80 study centers in Europe and Australia . Postmenopausal women ( n= 1226 ) with two or more prevalent vertebral fractures received risedronate 2.5 or 5 mg/day or placebo ; all subjects also received elemental calcium 1000 mg/day , and up to 500 IU/day vitamin D if baseline levels were low . The study duration was 3 years ; however , the 2.5 mg group was discontinued by protocol amendment after 2 years . Lateral spinal radiographs were taken annually for assessment of vertebral fractures , and bone mineral density was measured by dual-energy X-ray absorptiometry at 6-month intervals . Risedronate 5 mg reduced the risk of new vertebral fractures by 49 % over 3 years compared with control ( p<0.001 ) . A significant reduction of 61 % was seen within the first year ( p= 0.001 ) . The fracture reduction with risedronate 2.5 mg was similar to that in the 5 mg group over 2 years . The risk of nonvertebral fractures was reduced by 33 % compared with control over 3 years ( p= 0.06 ) . Risedronate significantly increased bone mineral density at the spine and hip within 6 months . The adverse-event profile of risedronate , including gastrointestinal adverse events , was similar to that of control . Risedronate 5 mg provides effective and well-tolerated therapy for severe postmenopausal osteoporosis , reducing the incidence of vertebral fractures and improving bone density in women with established disease Summary To develop an improved treatment schedule for osteoporosis , a study was undertaken in 100 postmenopausal women using a modified ADFR 90-day cyclical regimen with etidronate . After one year of treatment , the etidronate-treated group showed a significant increase in bone density of the spine , which continued over the following 2 years of treatment and remained stable during the fourth year . In contrast , in the non-etidronate group , bone density decreased significantly after four years . In addition , the fracture rate was significantly lower in the etidronate group than in the non-etidronate group . Side effects were minimal in both groups and no serious adverse reactions were reported . In conclusion , it appears that a cyclical regimen using 1,25-dihydroxyvitamin D3 , etidronate and calcium increases bone mass and reduces fractures with no significant side effects , thus making a useful contribution in the treatment of postmenopausal osteoporosis BACKGROUND Risedronate increases bone mineral density in elderly women , but whether it prevents hip fracture is not known . METHODS We studied 5445 women 70 to 79 years old who had osteoporosis ( indicated by a T score for bone mineral density at the femoral neck that was more than 4 SD below the mean peak value in young adults [ -4 ] or lower than -3 plus a nonskeletal risk factor for hip fracture , such as poor gait or a propensity to fall ) and 3886 women at least 80 years old who had at least one nonskeletal risk factor for hip fracture or low bone mineral density at the femoral neck ( T score , lower than -4 or lower than -3 plus a hip-axis length of 11.1 cm or greater ) . The women were r and omly assigned to receive treatment with oral risedronate ( 2.5 or 5.0 mg daily ) or placebo for three years . The primary end point was the occurrence of hip fracture . RESULTS Overall , the incidence of hip fracture among all the women assigned to risedronate was 2.8 percent , as compared with 3.9 percent among those assigned to placebo ( relative risk , 0.7 ; 95 percent confidence interval , 0.6 to 0.9 ; P=0.02 ) . In the group of women with osteoporosis ( those 70 to 79 years old ) , the incidence of hip fracture among those assigned to risedronate was 1.9 percent , as compared with 3.2 percent among those assigned to placebo ( relative risk , 0.6 ; 95 percent confidence interval , 0.4 to 0.9 ; P=0.009 ) . In the group of women selected primarily on the basis of nonskeletal risk factors ( those at least 80 years of age ) , the incidence of hip fracture was 4.2 percent among those assigned to risedronate and 5.1 percent among those assigned to placebo ( P=0.35 ) . CONCLUSIONS Risedronate significantly reduces the risk of hip fracture among elderly women with confirmed osteoporosis but not among elderly women selected primarily on the basis of risk factors other than low bone mineral density We present final results of a study comparing teriparatide 20 μg every day ( QD ) with risedronate 35 mg once per week ( QW ) started within 2 weeks after surgery for a pertrochanteric hip fracture . Patients with BMD T-score ≤ -2.0 and 25OHD ≥9.2 ng/mL were r and omized to receive 26-week double-dummy treatment plus calcium and vitamin D , followed by 52-week open-label treatment with the same assigned active drug . Primary endpoint was change from baseline in lumbar spine ( LS ) BMD at 78 weeks . Secondary and exploratory endpoints were change in BMD at the proximal femur , function , hip pain ( Charnley score and 100 mm Visual Analog Scale [ VAS ] ) , quality of life ( Short Form-36 ) , radiology outcomes , and safety . Data were analyzed with mixed models for repeated measures ( MMRM ) and logistic regression . Totally , 224 patients were r and omized ; 171 ( teriparatide : 86 ) contributed to the efficacy analyses ( mean ± SD age : 77 ± 7.7 years , 77 % females ) . Mean baseline LS , femoral neck ( FN ) , and total hip ( TH ) T-scores were -2.16 , -2.63 , and -2.51 , respectively . At 78 weeks , BMD increased significantly more with teriparatide compared to risedronate at the LS ( + 11.08 % versus + 6.45 % ; p < 0.001 ) and FN ( + 1.96 % versus -1.19 % ; p = 0.003 ) , with no significant between-group difference in TH BMD . Timed up- and -go ( TUG ) test was significantly faster with teriparatide at 6 , 12 , 18 , and 26 weeks ( differences : -3.2 to -5.9 s ; p = 0.045 for overall difference ) . Hip pain during TUG test by 100 mm VAS was significantly lower with teriparatide at 18 weeks ( adjusted difference : -11.3 mm , p = 0.033 ; -10.0 and -9.3 mm at 12 and 26 weeks , respectively ; p = 0.079 for overall difference ) . Other secondary and exploratory outcomes were not different . Teriparatide group showed two new hip fractures versus seven with risedronate ( p = 0.171 ) and more frequent hypercalcemia and hyperuricemia . In conclusion , 78-week treatment with teriparatide showed significantly greater increases in LS and FN BMD , less pain , and a faster TUG test versus risedronate . © 2016 American Society for Bone and Mineral Research Abstract : To examine the risk of mortality following all clinical fractures , we followed 6459 women age 55–81 years participating in the Fracture Intervention Trial for an average of 3.8 years . All fractures and deaths were confirmed by medical record or death certificate . Clinical fractures were fractures that came to medical attention . Fracture status was used as a time-dependent covariate in proportional hazards models . The 907 women who experienced a fracture were older , had lower bone mineral density and were more likely to report a positive fracture history . A total of 122 women died over the course of the study with 23 of these deaths occurring after a clinical fracture . The age-adjusted relative risk ( 95 % confidence intervals ) of dying following a clinical fracture was 2.15 ( 1.36 , 3.42 ) . This primarily reflected the higher mortality following a hip fracture , 6.68 ( 3.08 , 14.52 ) ; and clinical vertebral fracture , 8.64 ( 4.45 , 16.74 ) . Results were similar after adjusting for treatment assignment , health status and specific common comorbidities . There was no increase in mortality following a forearm or other fracture ( non-hip , non-wrist , non-vertebral fracture ) . In conclusion , clinical vertebral fractures and hip fractures are associated with a substantial increase in mortality among a group of relatively healthy older women BACKGROUND Previous studies have shown that alendronate can increase bone mineral density ( BMD ) and prevent radiographically defined ( morphometric ) vertebral fractures . The Fracture Intervention Trial aim ed to investigate the effect of alendronate on the risk of morphometric as well as clinical ly evident fractures in postmenopausal women with low bone mass . METHODS Women aged 55 - 81 with low femoral-neck BMD were enrolled in two study groups based on presence or absence of an existing vertebral fracture . Results for women with at least one vertebral fracture at baseline are reported here . 2027 women were r and omly assigned placebo ( 1005 ) or alendronate ( 1022 ) and followed up for 36 months . The dose of alendronate ( initially 5 mg daily ) was increased ( to 10 mg daily ) at 24 months , with maintenance of the double blind . Lateral spine radiography was done at baseline and at 24 and 36 months . New vertebral fractures , the primary endpoint , were defined by morphometry as a decrease of 20 % ( and at least 4 mm ) in at least one vertebral height between the baseline and latest follow-up radiograph . Non-spine clinical fractures were confirmed by radiographic reports . New symptomatic vertebral fractures were based on self-report and confirmed by radiography . FINDINGS Follow-up radiographs were obtained for 1946 women ( 98 % of surviving participants ) . 78 ( 8.0 % ) of women in the alendronate group had one or more new morphometric vertebral fractures compared with 145 ( 15.0 % ) in the placebo group ( relative risk 0.53 [ 95 % Cl 0.41 - 0.68 ] ) . For clinical ly apparent vertebral fractures , the corresponding numbers were 23 ( 2.3 % ) alendronate and 50 ( 5.0 % ) placebo ( relative hazard 0.45 [ 0.27 - 0.72 ] ) . The risk of any clinical fracture , the main secondary endpoint , was lower in the alendronate than in the placebo group ( 139 [ 13.6 % ] vs 183 [ 18.2 % ] ; relative hazard 0.72 [ 0.58 - 0.90 ] ) . The relative hazards for hip fracture and wrist fracture for alendronate versus placebo were 0.49 ( 0.23 - 0.99 ) and 0.52 ( 0.31 - 0.87 ) . There was no significant difference between the groups in numbers of adverse experiences , including upper-gastrointestinal disorders . INTERPRETATION We conclude that among women with low bone mass and existing vertebral fractures , alendronate is well tolerated and substantially reduces the frequency of morphometric and clinical vertebral fractures , as well as other clinical fractures Abstract Objective : Women without versus those with vertebral fracture may have different benefits and risks during raloxifene treatment . Our objective was to compare the effects of raloxifene to decrease risk for vertebral fracture and invasive breast cancer with its effect to increase risk for venous thromboembolism in postmenopausal women without or with baseline vertebral fracture . Research design and methods : The Multiple Outcomes of Raloxifene Evaluation trial included postmenopausal women with osteoporosis r and omized to placebo , raloxifene 60 mg/day , or raloxifene 120 mg/day for 4 years . The protocol specified subgroups based on whether or not patients had a vertebral fracture at baseline . Absolute differences between placebo and raloxifene 60 mg/day ( the approved dose ) for endpoints in these groups were defined as the incidence in the raloxifene group minus the incidence in the placebo group . Results : Raloxifene decreased the incidence of vertebral fracture and invasive breast cancer while increasing the incidence of venous thromboembolism . All treatment by vertebral fracture status interaction p-values were greater than 0.13 , indicating that the effect of raloxifene on these outcomes was not significantly different between patients without versus those with vertebral fractures . In women without baseline vertebral fracture , absolute risk differences between the raloxifene and placebo group included vertebral fracture −2.83 % , invasive breast cancer −1.
Output:
| Our study demonstrated the effectiveness of anti-osteoporotic agents included in our systematic review in preventing secondary vertebral fractures .
Bisphosphonates and PTH were most effective in preventing non-vertebral fractures . |
MS213516 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Poor neuroleptic response is a major unresolved clinical problem . Precise data concerning the frequency of poor neuroleptic response are not available . The implementation of treatment modalities that are specifically recommended for non‐responders ( such as clozapine ) increases the desirability of such data . This study evaluated the proportion of acutely exacerbated schizophrenics who remained unimproved by consecutive administration of haloperidol , chlorpromazine and perphenazine , in r and omly determined order . The overall improvement rate was 95 % . The frequency of good responses to the first , second and third drug were 67 % , 55 % , and 67 % respectively . Differences in receptor affinity profile might explain the added beneficial effect of a second or third drug The relative efficacy of 4 tranquilizers was investigated in 66 chronic schizophrenics who had been hospitalized for 10.01 years ( mean ) . The role of adding an anti-depressant was also studied . Following a 4 week placebo period , high dosage tranquilizers were given for 16 weeks and amitriptyline was added for the following 16 weeks . Statistical analyses of the various change measures revealed that patients worsened significantly on placebo , all 4 tranquilizers were significantly better than placebo for symptom reduction and maximum improvement was attained within 16 weeks of tranquilizer administration . No significant differences in efficacy were observed among the 4 tranquilizers and addition of amitriptyline did not confer any additional therapeutic advantage The results of a prospect i ve study on the incidence of thrombocytopenia in matched psychiatric in patients receiving different antipsychotics are reported . Patients were receiving haloperidol ( N = 159 ) , chlorpromazine ( N = 164 ) , fluphenazine decanoate ( N = 152 ) , or no drug therapy ( control , N = 102 ) . The groups did not differ statistically in respect to the incidence of thrombocytopenia , mean platelet levels , age , chlorpromazine equivalent dosages , or duration of drug therapy ( p > 0.05 ) . The two phenothiazine-treated groups had significantly higher numbers of patients with lownormal platelet levels when compared to both the haloperidol and control groups ( p < 0.05 ) . Also , a nonsignificant trend was noted for increased incidence of thrombocytopenia among the phenothiazine groups compared with the haloperidol and control groups . Upon retrospective analysis of preneuroleptic treatment platelet levels , significant decreases in platelet values were observed with the phenothiazine-treated patients ( p < 0.001 ) , but not with haloperidol ( p > 0.05 ) . The results indicate that neuroleptic drug-induced thrombocytopenia is rare but may be more common with phenothiazine antipsychotics The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas The effectiveness of injectable chlorpromazine was compared with the effectiveness of injectable haloperidol with highly agitated , acute psychotic patients and chronic patients with acute exacerbations . While both groups improved , haloperidol effected a significantly greater improvement in patients 40 years of age or older than did chlorpromazine . This result is consistent with those reported in other studies In a double-blind , cross-over study , the comparative therapeutic effects of 6-week courses of two prototypic neuroleptics — haloperidol and chlorpromazine — and the reversal of those effects with benztropine were investigated in a group of 18 schizophrenics . Periodic measurements were made for 32 dimensions of psychopathology , social participation , span of attention , sleeplessness , pulse rate and neurological side effects . The results showed that haloperidol was generally a more effective drug over the period studied . This was particularly apparent in terms of social and emotional responsiveness , communicativeness and cognitive processes . The only superiority of chlorpromazine seemed to be that patients felt less dysphoric on it than they did on haloperidol . Haloperidol also proved to be more rapid in its action . The data failed to support the clinical validity of the distinction often made between “ sedative ” and “ activating ” neuroleptics . Consistent with previous reports , benztropine had the effect of diminishing therapeutic response to both neuroleptics . However , haloperidol again proved less susceptible to this effect . The slowness and lesser therapeutic efficiency of chlorpromazine and its greater susceptibility to benztropine reversal were all considered to be due to its built-in anticholinergic properties acting in opposition to its antipsychotic activity . The low potency of chlorpromazine-like drugs was attributed to their inherent anticholinergic characteristics . It was suggested that one of the factors determining potency differences among neuroleptics may be the degree of built-in anticholinergic activity A study of anti‐Parkinsonism agents in prolonged phenothiazine therapy seeks to clarify some anecdotal misconceptions . Antiparkinsonian agents do not appear to affect the therapeutic efficiency of phenothiazines , nor does using them on a “ dem and ” basis increase the problems of control of parkinsonian side effects . Older patients , however , appear to require the extended usage of antiparkinsonian agents rather more than some studies would suggest . Sustained release antiparkinsonian agents may yet further simplify the management of schizophrenia A study design ed to assess the relative efficacy of chlorpromazine and Serenace in the control of chronic schizophrenics is described . Twenty-five cases were selected for the study and were r and omly allocated to treatment . The condition of the patients was assessed at fortnightly intervals over the eight-week duration of trial period . No significant differences in side-effects emerged in patients on chlorpromazine and Serenace in the dosages administered . The statistically significant trends all showed a superiority of Serenace above chlorpromazine which was in accord with the clinical picture The schizophrenic patient 's early psychological response to neuroleptic treatment has been demonstrated to be a significant predictor of treatment response . The validity of the construct of subjective response is evaluated by comparison of two measures . Fifty-five recently admitted and unmedicated schizophrenic patients were r and omly allocated to chlorpromazine or haloperidol . Subjective responses at 24 and 48 hours as assessed by two different scales , the Van Putten & May scale and the self-administered Drug Attitude Inventory , were strongly correlated with outcome at three weeks . Early emergence of extrapyramidal symptoms was not related to subjective response , but dysphoric patients had a greater incidence of EPS by the end of treatment than did non-dysphoric patients . The two measures showed high concordance in identification of early drug dysphoria In this paper we have described early applications of computerized EEG techniques in psychopharmacology . Perhaps our most remarkable finding was there were practically no differences between very chronic drug free schizophrenic patients and normals , which contradicts much of the EEG imaging literature . To us , the most likely explanation is that most of the anterior slowing observed in other studies was due to contamination from orbital artifacts , which we took exceptional pains to remove . Lingering effects of neuroleptic medications may also have contributed . Alternatively , EEG deviations in schizophrenia may recede when the illness reaches a very chronic stage , although this hypothesis is less tenable . There were significant differences between placebo and the three neuroleptics in terms of increased amplitudes in the delta and theta frequency b and s in the anterior head regions , which is compatible with data from other studies . These changes were most pronounced with clozapine and least prominent with haloperidol , with chlorpromazine occupying an intermediate position . This order happens to parallel their relative antiserotonergic , antihistaminic and anticholinergic properties . The latter may have been partially obscured by the addition of benztropine . In a subgroup of patients who were recorded under each of the treatment conditions , there were more fast frequencies with clozapine than with the other neuroleptics agreeing with Roubicek and Major . This could be a function of clozapine 's increased adrenergic activity as reported by Ackenheil . An unexpected finding was that patients who responded to clozapine had higher amplitudes in the alpha spectrum , most pronounced in the left anterior quadrant , than did the nonresponders . These differences between responders and nonresponders obtained whether patients were on placebo , haloperidol or clozapine . Curiously , Buchsbaum et al. found that anxious patients who responded to benzodiazepines also had higher alpha amplitudes in the same brain regions , which differentiated them from nonresponders . These findings clearly warrant future scientific investigation . In this regard , the generalizability of our data is limited by the extremely chronic , treatment-resistant population studied . However , promising directions for further research in EEG and psychopharmacology have been identified In a controlled study , inpatient violence was measured during placebo , high-potency ( haloperidol ) and low-potency ( chlorpromazine or clozapine ) neuroleptics . Some patients had a marked increase in violent behavior with the moderately high-dose haloperidol , but not with low-potency neuroleptics . The authors discuss reasons for the increased violence with haloperidol , including akathisia and drug-induced behavioral toxicity The purpose of this study was to investigate whether L-DOPA antagonizes chlorpromazineor haloperidol-induced parkinsonism in schizophrenic patients . The following considerations motivated our research : a ) in Parkinson ’s disease there is a decrease in the dopamine content of the corpus striaturn and the substantia nigra ( Ehringer & Hornykiewicz 1960 ; Hornykiewicz 1963 ; Barolin et al. 1964 ) ; b ) L-DOPA increases dopamine concentration in the extrapyramidal centres ( Bertler & Rosengren 1959 ) : c ) L-DOPA antagonizes reserpine-induced parkinsonism ( Degkwitz et al. 1960 ) and the extrapyramidal symptoms of Parkinson ’s disease ( Birkmayer & Hornykiewicz 1961 , 1962 , 1964 ; Barbeau et al. 1962 ; Friedhoff et al. 1963 ; Gerstenbr and et al. 1963 ) ; d ) chlorpromazine and haloperidol produce a very significant increase in dopamine and homovanillic acid ( HVA ) urinary excretion when schizophrenics , treated with large therapeutic doses , show marked extrapyramidal symptoms ( Bruno et al. 1963 ; Bruno & Allegranza 1965 ) Extrapyramidal side effects of neuroleptics are important in clinical practice . Study of extra-pyramidal side effects is also of importance for research ers who test new antipsychotic agents or study tardive dyskinesia . A french translation of the Simpson-Angus Rating Scale of extra-pyramidal side effects thus appeared useful . This scale contains 10 items : Gait , Arm dropping , Shoulder shaking . Elbow rigidity , Wrist rigidity , Leg pendulousness , Head dropping , Glabella Tap , Tremor , Salivation . Each item is rated between 0 and 4 . A total score is obtained by adding the items and dividing by 10 . Scores of up to 0.3 are considered within the normal range . The scale original has been vali date d in a population of fourteen psychotic in patients taking , in a double-blind procedure , placebo , haloperidol 6 mg/day or haloperidol 30 mg/day . Patients receiving haloperidol 30 mg/day presented more extrapyramidal symptoms than patients under placebo . The Simpson Angus rating scale has also been shown to have clinical validity and high inter-rater reliability . It can be routinely used in clinical drug evaluation . The french version was used in a population of 30 psychotic in patients fulfilling the DSM III-R criteria of schizophrenic disorder . Patients were treated for at least two weeks , orally , either with a phenothiazine ( chlorpromazine 350 mg ) or a butyrophenone ( haloperidol 15 mg ) . 10 of the 30 patients received , in addition , anticholinergic agents ( trihexiphenidyl , 5 mg ) . The french version of The Simpson Angus Rating Scale appeared to be easy to use and not time-consuming . Interraters correlation was high . Patients receiving butyrophenones or phenothiazines had no significantly different ages and sociodemographic characteristics . ( ABSTRACT TRUNCATED AT 250 WORDS Trade names of drugs mentioned in this paper : haloperidol , Haldol ( McNeil Laboratories , Fort Washington , Pa. ) ; ehlorpromazine , Thorazine ( Smith Kline and French , Philadelphia , Pa. ) ; ben
Output:
| Given that haloperidol and chlorpromazine are global st and ard antipsychotic treatments for schizophrenia , it is surprising that less than 800 people have been r and omised to a comparison and that incomplete reporting still makes it difficult for anyone to draw clear conclusions on the comparative effects of these drugs .
However , it seems that haloperidol causes more movement disorders than chlorpromazine , while chlorpromazine is significantly more likely to lead to hypotonia . |
MS213517 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The topiramate study was a 12-month r and omized placebo-controlled trial in patients with ALS . Follow-up evaluation of the placebo group ( n = 97 ) constituted a well-described cohort of patients with ALS , in whom multiple outcome measures were assessed at 3-month intervals . During the 12-month study period , the decline of forced vital capacity ( FVC% ) and ALS functional rating scale ( ALSFRS ) was linear , whereas the decline of maximum voluntary isometric contraction – arm ( MVIC-arm ) and MVIC-grip Z scores was curvilinear . Rates of FVC% and ALFRS decline , but not of MVIC-arm or MVIC-grip , were independent predictors of survival Our objective was to determine the effect of creatine monohydrate on disease progression in patients with amyotrophic lateral sclerosis ( ALS ) . One hundred and seven patients with the diagnosis of probable or definite ALS , of less than five years duration from symptom onset , were r and omized to either treatment with daily creatine monohydrate ( 5 g/d ) or placebo . In this multicenter , double-blinded study we followed changes in disease progression : using quantitative measures of strength via maximal isometric voluntary contraction , forced vital capacity , ALSFRS , quality of life , fatigue and survival . Patients were followed for nine months . The results showed that creatine monohydrate did not significantly improve motor , respiratory or functional capacity in this patient population . The drug was well tolerated and the study groups well balanced , especially considering the absence of forced vital capacity criteria for entrance into the study . There was a trend toward improved survival in patients taking daily creatine monohydrate and this was identical to the trend seen in another recently published report of creatine in ALS patients 1 . In conclusion , creatine monohydrate ( 5 g/d ) did not have an obvious benefit on the multiple markers of disease progression measured over nine months . We measured fatigue during isometric contraction and found no significant improvement despite anecdotal patient reports prior to and during the study . The trend toward improved survival was also found in another recently completed blinded trial using creatine monohydrate . Further investigation on the possible survival benefit of creatine in this patient population is ongoing The ALS Functional Rating Scale ( ALSFRS ) is a vali date d rating instrument for monitoring the progression of disability in patients with amyotrophic lateral sclerosis ( ALS ) . One weakness of the ALSFRS as originally design ed was that it granted disproportionate weighting to limb and bulbar , as compared to respiratory , dysfunction . We have now vali date d a revised version of the ALSFRS , which incorporates additional assessment s of dyspnea , orthopnea , and the need for ventilatory support . The Revised ALSFRS ( ALSFRS-R ) retains the properties of the original scale and shows strong internal consistency and construct validity . ALSFRS-R scores correlate significantly with quality of life as measured by the Sickness Impact Profile , indicating that the quality of function is a strong determinant of quality of life in ALS The Scottish Motor Neuron Disease Register ( SMNDR ) is a prospect i ve , collaborative , population -based project which has been collecting data on incident patients since 1989 . In this report we present the clinical features of 229 patients with motor neuron disease ( 218 sporadic and 11 familial ) diagnosed in 1989 and 1990 and compare their prognosis with previous studies of survival . The overall 50 % survival from symptom onset was 2.5 years ( 95 % CI , 2.2–3.0 ) and 5-year survival 28 % ( 95 % Cl , 20–36 % ) . The presence of progressive bulbar palsy ( PBP ) , either at presentation or developing during the course of the illness , significantly reduced survival and was the most important prognostic indicator . Patients who survived longer than 5 years from symptom onset did not have BP as part of their presenting illness . The prognosis was worse for women , and this was in part related to the higher frequency of PBP in older women , but age was also an independent adverse risk factor . Differences in survival between this and previous series can probably be explained on the basis of variation in case definition and ascertainment methods Background : In recent years , there has been a paradigm shift in the method of healthcare delivery to amyotrophic lateral sclerosis ( ALS ) patients with the emergence of multidisciplinary ALS clinics that cater exclusively for patients with this condition . The impact of multidisciplinary management has not been previously evaluated . Methods : Using data from the Irish ALS Register , we conducted a prospect i ve , population based study of all ALS cases diagnosed in Irel and over a five year period to evaluate the effectiveness of a multidisciplinary clinic on ALS survival . Results : Eighty two ( 24 % ) patients attended the multidisciplinary ALS clinic , with the remaining 262 ( 76 % ) cases followed in a general neurology clinic . The ALS clinic cohort was an average of five years younger ( 60.1 v 65.6 years ) and were more likely to receive riluzole than the general neurology cohort ( 99 % v 61 % ) . The median survival of the ALS clinic cohort was 7.5 months longer than for patients in the general neurology cohort ( logrank = 15.4 , p < 0.0001 ) . Overall , one year mortality was decreased by 29.7 % . Prognosis of bulbar onset patients was extended by 9.6 months if they attended the ALS clinic . Using multivariate analysis , attendance at the ALS clinic was an independent covariate of survival ( HR = 1.47 , p = 0.02 ) . Conclusions : ALS patients who received their care at a multidisciplinary clinic had a better prognosis than patients attending a general neurology clinic . The data suggest that active and aggressive management enhances survival , particularly among ALS patients with bulbar dysfunction . The effect of clinic type must be considered in future clinical trials design Objective : To determine the incidence , prevalence , and mortality rates of ALS in the province of Modena , Northern Italy , from 1990 through 1999 . Methods : A retrospective epidemiologic study was conducted , ascertaining cases from all neurologic centers and hospitals of the province , death certificates , and the Italian ALS Association , section of Modena . All clinical records were review ed , and only patients fulfilling the El Escorial revised diagnostic criteria were included . Results : During the period considered ( 1990 to 1999 ) , 143 residents ( 67 men and 76 women ) entered the study . The average annual incidence was 2.16 per 100,000 , with a peak in the age class of 75 to 79 years . Mean prevalence rate was 4.02 per 100,000 , and mean mortality rate was 1.69 per 100,000 . The incidence rate remained constant over time , whereas the prevalence and mortality rates increased owing to a rise in survival time ( ALS mean duration was 17.38 months in 1990 , 43.18 months in 1999 ) . In the mountainous areas , where agricultural work is more common , the incidence , prevalence , and mortality rates were higher than in urban areas and the disease onset occurred 10 years later . Of the risk factors examined , only agricultural work and rural residence were significant . Conclusions : The incidence , prevalence , and mortality rates agree with those in recent Italian surveys and with most international studies , but the distribution of cases varied with higher rates in mountainous areas . Further prospect i ve studies are required ALS is a progressive motor neuron disease with no effective treatment . The anti-excitotoxic drug riluzole ( 100 mg/day ) has been shown to decrease mortality and muscular deterioration in ALS patients . To confirm and extend the therapeutic effect of riluzole , we performed a double-blind , placebo-controlled , multicenter , international , dose-ranging ( 50 , 100 , 200 mg/day ) , stratified study in 959 ALS out patients treated for up to 18 months . Primary efficacy criterion was survival and the effect of treatment was analyzed before ( Wilcoxon and log rank tests ) and after adjustment on prognostic factors ( Cox model ) . Secondary efficacy criterion was disease progression assessed through change in functional measures . Tracheostomy-free survival rates were : 50.4 % ( placebo ) , 55.3 % ( 50 mg riluzole ) ( p = 0.23 , Wilcoxon test ; p = 0.25 , log-rank test ) , 56.8 % ( 100 mg riluzole ) ( p = 0.05 , Wilcoxon test ; p = 0.076 , log-rank test ) , and 57.8 % ( 200 mg riluzole ) ( p = 0.061 , Wilcoxon test ; p = 0.075 , log-rank test ) . At the end of the 18-month study , there was a significant dose-related decrease in risk of death or tracheostomy ( p = 0.04 ) . Adjustment for baseline prognostic factors showed a 35 % decreased risk of death with the 100-mg dose compared with placebo ( p = 0.002 ) . No significant treatment effects were detected for the functional assessment s. The most frequent dose-related adverse events included nausea , asthenia , and elevated liver enzyme levels . This study confirms the therapeutic effect of riluzole in a large representative ALS sample , over an 18-month period . Riluzole is well tolerated and decreases the risk of death or tracheostomy in ALS patients . NEUROLOGY 1996;47(Suppl 4 ) : Creatine supplementation in humans has been reported to enhance power and strength both in normal subjects and in patients with various neuromuscular diseases . The purpose of this study was to examine the effects of supplementation on exercise performance and maximal voluntary isometric muscular contraction ( MVIC ) in Amyotrophic Lateral Sclerosis ( ALS ) patients . We report the results obtained in 28 patients with probable/definite ALS . In each patient we acquired the dynamometric measurement of MVIC in 10 muscle groups of upper and lower limbs and a measure of fatigue by means of an high-intensity intermittent protocol in elbow flexors and knee extensors muscles . All patients completed the protocol s at the baseline and after supplementation of 20 g per day for 7 days and after supplementation of 3 g per day for 3 and 6 months . MVIC increased after 7 days of supplementation in 20 patients ( 70 % ) in knee extensors and in 15 ( 53 % ) of them also in elbow flexors . A statistically significant difference between pre and post-treatment mean values of MVIC was found both in elbow flexors ( P<0.05 ) and knee extensors ( p<0.04 ) . The analysis of the slopes of fatigue test showed a statistically significant improvement after 7 days of supplementation in 11 patients ( 39 % ) in elbow flexors and in 9 patients ( 32 % ) also in knee extensors muscles . During the 6-month follow-up period all the examined parameters showed a linear progressive decline . In conclusion , our preliminary results have demonstrated that supplementation temporary increases maximal isometric power in ALS patients so it may be of potential benefit in situations such as high intensity activity and it can be proposed as a symptomatic treatment Amyotrophic lateral sclerosis ( ALS ) is a fatal disease with no cure . In a transgenic mouse model of ALS , creatine monohydrate showed a promising increase in survival . We performed a double‐blind , placebo‐controlled , sequential clinical trial to assess the effect of creatine monohydrate on survival and disease progression in patients with ALS . Between June 2000 and December 2001 , 175 patients with probable , probable‐laboratory supported , or definite ALS were r and omly assigned to receive either creatine monohydrate or placebo 10gm daily . A sequential trial design was used with death , persistent assisted ventilation , or tracheostomy as primary end points . Secondary outcome measurements were rate of decline of isometric arm muscle strength , forced vital capacity , functional status , and quality of life . The trial was stopped when the null hypothesis of indifference was accepted . Creatine did not affect survival ( cumulative survival probability of 0.70 in the creatine group vs 0.68 in the placebo group at 12 months , and 0.52 in the creatine group vs 0.47 in the placebo group at 16 months ) , or the rate of decline of functional measurements . Creatine intake did not cause important adverse reactions . This placebo‐controlled trial did not find evidence of a beneficial effect of creatine monohydrate on survival or disease progression in patients with ALS . Ann Neurol Amyotrophic lateral sclerosis is a rapidly progressive disease of unknown etiology result ing in tetraparalysis , dysarthria , dysphagia , and ultimately death from respiratory insufficiency . In the course of the disease , recurrent episodes of aspiration , pneumonia , dehydration , and malnutrition may necessitate nasoenteral tube placement , an inconvenient and unattractive arrangement in patients with dribbling and impaired swallowing . A percutaneous endoscopic gastrostomy seemed a better , though potentially hazardous , alternative in view of the often severely restricted pulmonary function of these patients . Therefore , we prospect ively investigated the use of percutaneous endoscopic g
Output:
| Creatine was reportedly well-tolerated in all three included studies , with no evidence of renal failure or serious adverse events specifically attributable to creatine .
In patients already diagnosed with clinical ly probable or definite amyotrophic lateral sclerosis ( ALS ) , creatine at doses ranging from 5 to 10 g per day did not have a statistically significant effect on survival , ALS functional rating revised scores ( ALSFRS-R ) progression or percent predicted forced vital capacity ( FVC ) progression |
MS213518 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Background : Patients receiving chemotherapy for cancer often develop anemia , which can contribute to increased morbidity and reduced quality of life ( QOL ) . Chemotherapy-induced anemia can be successfully treated using recombinant human erythropoietin ( rHuEPO ) . Aim of the study : To demonstrate the effectiveness of once-weekly ( QW ) rHuEPO dosing to effect improved hemoglobin levels , decreased transfusion use , and improved functional outcomes and QOL in pediatric leukemic patients ( ALL ) receiving maintenance chemotherapy . Patient and methods : This was a prospect i ve r and omized , single-center , open-label , 12-week case-control study of epoetin alfa in pediatric patients with acute lymphoblastic leukemia ( ALL ) in remission receiving maintenance chemotherapy . Sixty patients were r and omly assigned to receive either epoetin alfa ( rHuEPO group = 30 cases , 17 males and 13 females , age ; 6.8 ± 2.33 years ) , or no epoetin alfa ( control group = 30 cases , 16 males and 14 females , age ; 6.76 ± 2.28 years ) . Both groups were matched as regard age , sex , baseline Hb concentration , remission state , chemotherapy regimen , numbers and amount of blood transfusion , and leukemia state ( both were low and st and ard risk ) . Epoetin alfa was administered at a dose of 450 IU/kg , once weekly , subcutaneously ( s.c . ) for 12 consecutive weeks . Endpoints were changes in hematologic and QOL parameters . Results : Among the 30 patients evaluable for hematologic response , the mean increase in Hb from baseline to time of final evaluation was 3.08 ± 1.48 g/dl ( p < 0.001 ) . An increase in Hb of ≧ 2 g/dl , in the absence of blood transfusion , occurred in 70 % of patients ( 21 of 30 patients ) who were on the study for ≧ 30 days . The overall response rate ( Hb increase ≧ 2 g/dl or Hb ≧ 12 g/dl in the absence of blood transfusion ) was 90 % ( 27 of 30 patients ) . In 30 patients who were evaluable for QOL assessment , epoetin-α therapy was found to significantly ( p < 0.001 ) improve mean cancer linear analog scale ( CLAS ) scores for energy level , ability to perform daily activity , and overall QOL from baseline to the time of final evaluation . QW epoetin-α was found to be well tolerated . Conclusion : Treatment with QW epoetin-α was found to increase Hb levels , decrease transfusion requirement , and improve functional status and QOL in anemic patients with ALL in maintenance receiving chemotherapy . The once-weekly schedule is convenient , safe , and may reduce the burden on patients , parents , and their caregivers by reducing the number of visits to the clinic Using a multi-attribute approach , we and others have reported on the comprehensive health status of survivors of cancer in childhood , after completion of therapy . However , there is a dearth of information about health status and associated health-related quality of life ( HRQL ) in children and adults with cancer , during the treatment process ; a deficit which this study was intended to redress . All children ( n=18 ) receiving ' maintenance ' chemotherapy for acute lymphoblastic leukemia ( ALL ) at a single institution were assessed prospect ively through a single cycle of therapy . Patients , family members and health care professionals used global ratings , the health utilities index mark 2 ( HUI2 ) and mark 3 ( HUI3 ) classification systems , and detailed descriptions of temporary states of health , to provide independent assessment s of health status at weekly intervals . Utility scores were derived for each comprehensive health state and for single attribute levels of the HUI2 system , and for the temporary health state descriptions . The classification of the subjects into the most appropriate temporary health states was challenging even for older children and some of the parents . The HUI instruments were used much more easily and produced highly comparable information . The most frequently affected attributes were pain , emotion and mobility/ambulation ; in that order . The global ( p=0.005 ) and specific morbidity burdens were , as predicted , greatest in the middle of the cycle of chemotherapy , reflecting the toxicity of steroid use . HUI2 global utility scores demonstrated moderate responsiveness with an intra-class correlation coefficient of 0.43 . Cyclical administration of therapy , in particular corticosteroids , produces important changes in health status and HRQL in children with ALL . The HUI are valid and responsive systems for quantifying the burden of morbidity during the treatment of cancer in childhood . These are sensitive tools which can be used in a wide array of other circumstances to quantify changes in health status Background Glucocorticoids are important in the treatment of childhood acute lymphoblastic leukaemia ( ALL ) . However , cyclic administration of high dose glucocorticoids may cause rapid and substantial changes in quality of life ( QoL ) . The maintenance phase of the Dutch ALL-9 protocol consisted of alternating two weeks on and five weeks off dexamethasone ( 6 mg/m2/day ) . The present study was performed to assess the effect of dexamethasone on QoL during treatment for ALL according to this protocol . Methods In a multicentre prospect i ve cohort study , QoL was assessed halfway ( T1 ) and at the end of the two-year treatment ( T2 ) . A generic ( Child Health Question naire ) and disease specific ( PedsQL ™ cancer version ) QoL question naire were used to assess QoL in two periods : on and off dexamethasone , respectively . Results 41 children ( 56 % males ) were evaluated , mean age at diagnosis was 5.6 years . The CHQ physical and psychosocial summary scores were significantly lower than population norms . At T1 and T2 , overall QoL showed no significant change . However , regarding specific domains ( pain , cognitive functioning , emotion/behaviour and physical functioning ) QoL decreased over time . QoL was significantly more impaired during periods on dexamethasone . Conclusion Dexamethasone was associated with decreased QoL. At the end of treatment , reported QoL during dexamethasone deteriorated even more on certain scales ( pain , cognitive functioning , emotion/behaviour and physical functioning ) . Knowledge of the specific aspects of QoL is essential to improve counselling and coping in paediatric oncology . Adverse effects of specific drugs on QoL should be taken into account when design ing treatment protocol Background The quality of life of children with leukemia is reduced by fear and anxiety of parents after diagnosis , lack of information about the disease , treatments , and care of the child . This study aims to evaluate the effect of educating parents of leukemic children on the patients ’ quality of life . Methods In this interventional study , sixty parents of ALL children who met inclusion criteria were selected using simple r and om sampling method , and assigned to the experimental and control groups . The study tool included a valid and reliable question naire ( TNO-AZL ) , that was filled in through interview by parents before and two months after the intervention for both groups . The first part of the question naire included demographic items and the second part ( 7 dimensions , each with 8 sections ) contained questions related to the quality of life . The scores could range between 56 and 280 and a higher score represented a better quality of life . The intervention included three one-hour classes composed of lecture and question -answer sessions which were held for groups of 4 - 6 participants , accompanied by a booklet . Results Before the intervention , the quality of life score in the experimental and control groups was 180.83±14.43 and 174.28±20.72 , respectively ; after the intervention , these figures changed to 226.9±11.76 and 174.41±20.42 respectively . Paired sample s T-test proved a significant increase in the quality of life in the experimental group . Conclusion Parent education successfully increased the quality of life of leukemic children ; therefore , parental consultation sessions and educational programs are recommended BACKGROUND This study investigates the effect of using patient reported outcomes ( PROs ) about health-related quality of life ( HRQOL ) in clinical practice on the type and amount of psychosocial topics discussed during a paediatric oncology consultation . PROCEDURE Children ( N = 193 ) with cancer participated in a sequential cohort intervention study , with a control ( no PRO was used ) and intervention group ( a PRO was used ) . For each child three consecutive consultations with the paediatric oncologist were audio recorded in order to assess the discussed psychosocial topics . One third of the audio recordings were qualitatively analysed . RESULTS The type of the discussed psychosocial topics in the control and intervention group did not differ from each other . However , the discussion of psychosocial topics increased in the intervention group compared to the control group . In both groups , topics within the social domain occurred most frequently and topics regarding the emotional domain had the lowest incidence . CONCLUSIONS PROs do not change the psychosocial content of communication . Paediatric oncologists already address psychosocial issues during the consultation , regardless of the use of a PRO . However , with a PRO available they address these issues more systematic ally and more often Background Most studies on health-related quality of life ( HRQOL ) in children with cancer focussed on survivors . Only few studies have evaluated patients during ongoing oncological treatment . The aim of this study was a prospect i ve assessment of HRQOL in children during the first year after diagnosis of cancer and an examination of demographic , medical , and parental predictors of HRQOL . Methods Fifty-two patients ( mean age : 10.9 years ) were assessed 6 weeks and 1 year after diagnosis with the TNO-AZL Question naire for Children 's Health-Related Quality of Life . Parents completed the Brief Symptom Inventory . Results Compared to a community sample , patients reported more physical complaints , reduced motor functioning and autonomy , and impaired positive emotional functioning 6 weeks after diagnosis . HRQOL significantly improved over the year . However , at 1 year , patients still showed reduced motor and emotional functioning . At 6 weeks , children with leukemia were most affected . At 1 year , patients with brain tumors complained about more physical symptoms than the other groups . Intensity of treatment and presence of medical complications mainly influenced HRQOL at 6 weeks but less at 1 year . Parental psychopathology was associated with better cognitive functioning in the child . Conclusion This prospect i ve study found several domains of HRQOL to be compromised 6 weeks and 1 year after the diagnosis of cancer . Although HRQOL significantly increased over the year , there were important differences between diagnostic groups . The findings highlight the importance of repeated evaluation of HRQOL in children undergoing cancer treatment and consideration of specific differences between diagnostic groups The objective of the study was to assess acute neurotoxicity associated with triple intrathecal therapy (TIT)±high-dose methotrexate ( HD MTX ) in children with acute lymphoblastic leukemia ( ALL ) . 1395 children were enrolled on FRALLE 93 protocol from 1993 to 1999 . Lower-risk group ( LR , n=182 ) were r and omized to weekly low-dose MTX at 25 mg/m2/week ( LD MTX , n=81 ) or HD MTX at 1.5 g/m2/2 weeks × 6 ( n=77 ) . Intermediate-risk group ( IR , n=672 ) were r and omized to LD MTX ( n=290 ) or HD MTX at 8 g/m2/2 weeks × 4 ( n=316 ) . Higher-risk group ( HR , n=541 ) prednisone-responder patients received LD MTX and cranial radiotherapy . HR group steroid resistant cases were grafted ( autologous or allogenic ) . TIT ( MTX , cytarabine and methylprednisolone ) was given every 2 weeks during 16–18 weeks and every 3 months during maintenance therapy in LR and IR patients . 52 patients ( 3.7 % ) developed neurotoxicity . Isolated seizures : n=15 ( 1.1 % ) , peripheral and spinal neuropathy : n=17 ( 1.2 % ) and encephalopathy : n=20 ( 1.4 % ) . Age > 10 years was significantly associated with neurotoxicity ( P=0.01 ) and use of HD MTX is associated with encephalopathy ( P=0.03 ) . Sequels are reported respectively in 60 and 33 % of spinal neuropathy and encephalopathy cases . Current strategies tailoring risk of neurological sequels has to be defined St and ard risk acute lymphoblastic leukemia ( SR-ALL ) has high cure rates , but requires 2 - 3 years of therapy . We aim ed to ( i ) prospect ively evaluate health-related quality of life ( HRQOL ) during and after SR-ALL therapy , and ( ii ) identify associated predictors . Parents of 160 SR-ALL patients enrolled on Children 's Oncology Group ( COG ) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory ( PedsQL ) 4.0 Generic Core Scales ( physical , emotional and social functioning ) and Family Assessment Device-General Functioning ( FAD-GF ) at 1 , 6 and 12 months after diagnosis , and 3 months post-therapy . Mean PedsQL scores in physical , emotional and social functioning were impaired 1 month after diagnosis but steadily improved . Three months post-therapy , impaired physical and social functioning was observed in 27.8 and 25.8 % of patients , respectively . In repeated- measures analysis , problematic family functioning predicted emotional ( OR = 1.85 , 95 % CI 1.
Output:
| Overall HRQL was significantly reduced on treatment .
Despite HRQL improvements over time , longitudinal studies reported a proportion of children continued to experience reduced HRQL after treatment completion .
We found inconsistent associations between clinical /demographic factors and HRQL outcomes .
Tentative evidence emerged for worse HRQL being associated with intensive phases of chemotherapy , corticosteroid therapy , experiencing greater toxicity , older age , and female sex . |
MS213519 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: INTRODUCTION This 7-year , prospect i ve , matched-cohort , clinical study evaluated the effects of intramuscular depot medroxyprogesterone acetate ( DMPA ) ( 150 mg/mL ) on bone mineral density ( BMD ) in women aged 25 - 35 years . METHODS Bone mineral density changes in new DMPA-IM users ( n=248 ) were compared with those in women using nonhormonal contraception ( n=360 ) for up to 240 weeks of treatment and 96 weeks of posttreatment follow-up ( in subjects receiving > or=1 dose ) . RESULTS At week 240 of treatment , mean percentage changes from baseline in DMPA-IM vs. nonhormonal subjects were : -5.16 % ( n=21 ) vs. + 0.19 % ( n=65 ) , total hip ( p<.001 ) ; -5.38 % ( n=33 ) vs. + 0.43 % ( n=105 ) , lumbar spine ( p<.001 ) . At week 96 posttreatment , these values were : -0.20 % ( n=25 ) vs. + 0.84 % ( n=43 ) , total hip ( p=.047 ) ; -1.19 % ( n=41 ) vs. + 0.47 % ( n=66 ) , lumbar spine ( p=.017 ) . CONCLUSIONS These results show BMD declines during DMPA-IM use ; following discontinuation , significant increases in BMD occur through 96 weeks posttreatment A r and omized , single blind comparative trial of norethindrone enanthate ( NET-ENT ) and depo-medroxyprogesterone acetate ( DMPA ) was conducted in the Model Clinic , Decca , Bangladesh , to determine if there were differences in reported side effects , reasons for discontinuation and discontinuation rates of these two injectables . On all follow-up visits the proportion of women reporting no bleeding ( amenorrhea ) was higher for the DMPA clients compared to the NET-ENT clients . Concurrent with these findings , the proportion of women reporting irregular bleeding was consistently higher for the NET-ENT clients . Concurrent with these findings , the proportion of women reporting irregular bleeding was consistently higher for the NET-ENT clients compared to those receiving DMPA . By the fourth injection , less than 15 % of the clients in both drug groups still reported having regular cyclic bleeding ( 4 of the 26 DMPA clients and 4 of the 28 NET-ENT clients ) . Five of the 133 women on DMPA and 6 of the 106 women on NET-ENT became pregnant while using the injectables . At the end of one year of follow-up , 14 of the 133 DMPA and 14 of the 106 NET-ENT clients were still continuing ( came back for a fifth injection ) Final results are presented from a two-year WHO multinational comparative trial of three regimens : depot-medroxyprogesterone acetate ( DMPA ) given at 90-day intervals , norethisterone enanthate ( NET-EN ) given at 60-day intervals for the entire study period ( NET-EN ( 60-day ) ) , and NET-EN given at 60-day intervals for six months and thereafter at 84-day intervals ( NET-EN ( 84-day ) ) . 1587 DMPA subjects were observed for 20,550 woman-months , 789 NET-EN ( 60-day ) subjects were observed for 10,361 woman-months , and 796 NET-EN ( 84-day ) subjects were observed for 10,331 woman-months . This clinical trial represents the largest clinical trial undertaken on injectable contraceptives . After two years , the pregnancy rate with NET-EN ( 84-day ) was 1.4 ( + /- 0.6 S.E. ) per 100 women , as compared with the two-year rates of 0.4 ( + /- 0.3 S.E. ) per 100 women observed with DMPA and 0.4 ( + /- 0.2 S.E. ) with NET-EN ( 60-day ) . Both discontinuation rates for amenorrhea and the prevalence of amenorrhea lasting more than 90 days were significantly higher with DMPA than with either NET-EN regimen . Terminations for bleeding problems were similar with the three treatments , despite a better cyclic pattern for the first six months with the NET-EN regimens . The three treatments were comparable with respect to discontinuation rates for other medical or personal reasons , and for all reasons combined . For family planning programs , NET-EN ( 60-day ) has the advantage of low pregnancy rates compared to NET-EN ( 84-day ) , and a schedule of administration that does not change . Both NET-EN regimens produce less amenorrhea than DMPA . However , the NET-EN ( 60-day ) regimen has the logistic and economic disadvantage of requiring more frequent injections . All three injectable regimens compare favourably with oral contraceptives in terms of pregnancy and total continuation rates observed in clinical trial setting OBJECTIVE This study aims to assess changes in bleeding patterns with the use of depot medroxyprogesterone acetate ( DMPA ) 104 mg/0.65 ml subcutaneous injection ( DMPA-SC 104 ) . STUDY DESIGN An analysis was conducted using data from two 1-year , noncomparative clinical trials ( N=1787 ) and a 2-year r and omized study comparing DMPA-SC 104 ( N=266 ) with DMPA intramuscular injection ( DMPA-IM ) . Bleeding was analyzed per 30-day interval by category and number of days . Analyses also were performed for age and body mass index ( BMI ) subgroups and for the percentages of women shifting from bleeding/spotting to amenorrhea after each injection . RESULTS Each study showed decreased incidence of irregular bleeding and increased amenorrhea with continued use of DMPA-SC 104 . Rates of amenorrhea at Month 12 ( 52 - 64 % across studies ) and Month 24 ( 71 % in the 2-year trial ) were comparable with those originally reported for DMPA-IM . Changes in bleeding patterns showed no consistent differences according to age or BMI . The percentages of subjects shifting from bleeding and /or spotting to amenorrhea increased with each subsequent injection . CONCLUSION Clinical data show that the incidence of amenorrhea increases over time with the use of DMPA-SC 104 The acceptability of 2 and 3 month injectable contraceptives was assessed and compared , and the acceptability of the injectables was further compared with that of oral contraceptives ( OCs ) and IUDs among a r and om sample of women , who attended a clinic in Alex and ria , Egypt . The study was conducted by the University of Alex and ria . The sample included 100 acceptors of the 2-month injectable , norethisterone oenanthate ( NET-O EN ) , 100 acceptors of the 3-month injectable , depo-medroxy pregesterone acetate ( DPMA ) , 60 OC acceptors , and 60 IUD acceptors . The women were interviewed prior to treatment and 2 or 3 times during the 6 months following their initial acceptance of the methods . Women who discontinued at any time during the 6-month period were interviewed concerning their reasons for discontinuing . The data was analyzed by calculating means and % distribution and by testing for significance . The percent lost to follow up was 12 % for the NET-O EN group , 12 % for DPMA users , and 0 % for IUD and OC acceptors . The mean age of the acceptors was 30.4 years for NET-O EN , 30.7 years for DMPA , 28.3 years for OCs , and 25.2 years for IUDs . For these acceptor groups , the respective mean number of years of schooling was 6.1 , 5.2 , 7.2 , and 7.5 , and the respective mean number of pregnancies was 5.6 , 5.4 , 3.8 , and 2.9 . All 320 of the women were married , and 319 were Muslim . 99.4 % lived in urban areas . 10 % had no living male children , and 23.7 % had no living female children . 2/3 of the injectable acceptors previously used 2 or more fertility control methods . A higher percent of IUD and OC acceptors , compared to injectable acceptors , reported using only 1 or no previous method . More than 1/2 of the injectable acceptors reported disruptions in their normal bleeding patterns . NET-O EN acceptors were more likely to experience heavy or prolonged bleeding while DPMA acceptors were more likely to report amenorrhea or a decreased flow . IUD acceptors were also bothered by bleeding problems . Almost all the women who reported changes in bleeding patterns were unhappy about the changes . Many of the women who reported amenorrhea worried that they might be pregnant . Women who experienced heavy or unpredictable bleeding worried about anemia and complained that bleeding interfered with their daily routines . 47.6 % of the women reported weight gains , but this was generally viewed as an advantage . Nausea was the major side effect associated with OC use . 32 % of the OC users , 28.0 % of the NET-E ON users , 30.0 % of the DMPA users , and none of the IUD users reported nausea . For all 4 groups , convenience and effectiveness were the major advantages the women attributed to their chosen method . Continuation rates were 68 % for NET-O EN , 70 % for DMPA , 75 % for OCs , and 75 % for IUDs . The major reason for discontinuation of injectables was bleeding problems . Among injectable users , a higher proportion of discontinuers ( 49 % ) than of continuers ( 20 % ) reported amenorrhea . The findings suggest that continuation for injectables could be improved if patients were given more detailed information about possible side effects and if they were advised to return to the clinic for treatment of any symptoms they experience The present work was a r and omized comparative study of two injectable progestogen-only contraceptives . The first group ( 200 subjects ) received 150 mg of depotmedroxyprogesterone acetate ( Depoprovera ) every 84 + /- 7 days and the second ( 200 subjects ) received 200 mg of norethisterone enanthate ( Noristerat ) every 56 + /- 7 days . Acceptors of injectable contraceptives in Assiut , Egypt , were mainly women looking for fertility termination . Menstrual disruption was the main side effect among both treatment groups . Amenorrhoea was the commonest menstrual complaint and was the main reason for discontinuation in both groups . Only one pregnancy occurred during NET-EN use ; two more pregnancies occurred , one in each of the two groups but there were indications that conception preceded the first injection . Menstrual irregularities were generally more frequent with DMPA users . However , DMPA had better one-year continuation rates than NET-EN ( 68.8 + /- 3.5 and 57.1 + /- 3.6 per 100 women , respectively )
Output:
| While the choice between DPMA and NET-EN as injectable progestogen contraceptives may vary between both health providers and patients , data from r and omized controlled trials indicate little difference between the effects of these methods , except that women on DMPA are more likely to develop amenorrhoea .
There is inadequate data to detect differences in some non-menstrual major and minor clinical effects |
MS213520 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background —Diagnosis of coronary artery disease in women is more difficult because of lower specificity of symptoms and diagnostic accuracy of noninvasive testing . We sought to examine the relationship between gender and cardiac biomarkers in patients with unstable angina (UA)/non – ST-segment elevation myocardial infa rct ion ( NSTEMI ) . Methods and Results —In the TACTICS-TIMI 18 , OPUS-TIMI 16 , and TIMI 11 studies , baseline sample s were analyzed in the Thrombolysis In Myocardial Infa rct ion ( TIMI ) biomarker core laboratory . We examined the relationship between gender and elevated biomarkers . Of 1865 patients from TACTICS-TIMI 18 , 34 % were women . Fewer women had elevated creatine kinase-MB or troponins , whereas more had elevated high-sensitivity C-reactive protein or brain natriuretic peptide . Presence of ST-segment deviation and TIMI risk scores were not significantly different . This pattern was confirmed in TIMI 11 and OPUS-TIMI 16 . The prognostic value of the markers in TACTICS-TIMI 18 was similar in women and men . When a multimarker approach was examined , a greater proportion of high-risk women were identified . Marker-positive patients of both genders had improved outcome with an invasive strategy ; however , marker-negative women appeared to have improved outcomes with a conservative strategy . Conclusions —In patients with UA/NSTEMI , there was a different pattern of presenting biomarkers . Men were more likely to have elevated creatine kinase-MB and troponins , whereas women were more likely to have elevated C-reactive protein and brain natriuretic peptide . This suggests that a multimarker approach may aid the initial risk assessment of UA/NSTEMI , especially in women . Further research is necessary to eluci date whether gender-related pathophysiological differences exist in presentation with acute coronary syndromes Background Several studies have suggested sex‐related differences in diagnostic and invasive therapeutic coronary procedures . Methods and Results Data from consecutive patients who were enrolled in the Coronary Angiography and PCI Registry of the German Society of Cardiology were analyzed . We aim ed to compare sex‐related differences in in‐hospital outcomes of patients undergoing percutaneous coronary intervention ( PCI ) for stable coronary artery disease , non‐ST elevation acute coronary syndromes , ST elevation myocardial infa rct ion , and cardiogenic shock . From 2007 until the end of 2009 data from 185 312 PCIs were prospect ively registered : 27.9 % of the PCIs were performed in women . Primary PCI success rate was identical between the sexes ( 94 % ) . There were no sex‐related differences in hospital mortality among patients undergoing PCI for stable coronary artery disease , non‐ST elevation acute coronary syndromes , or cardiogenic shock except among ST elevation myocardial infa rct ion patients . Compared to men , women undergoing primary PCI for ST elevation myocardial infa rct ion have a higher risk of in‐hospital death , age‐adjusted odds ratio ( 1.19 , 95 % CI 1.06‐1.33 ) , and risk of ischemic cardiac and cerebrovascular events ( death , myocardial infa rct ion , transient ischemic attack/stroke ) , ( age‐adjusted odds ratio 1.19 , 95 % CI 1.16‐1.29 ) . Furthermore , access‐related complications were twice as high in women , irrespective of the indication . Conclusions Despite identical technical success rates of PCI between the 2 sexes , women with PCI for ST elevation myocardial infa rct ion have a 20 % higher age‐adjusted risk of death and of ischemic cardiac and cerebrovascular events . Further research is needed to determine the reasons for these differences BACKGROUND Gender and age are non-modifiable factors influencing clinical outcomes in acute coronary syndromes ( ACS ) . There is evidence that coronary artery disease pathophysiology varies in women . We therefore evaluated the effect of age and gender on clinical outcomes in patients with ACS undergoing percutaneous coronary interventions ( PCI ) . METHODS Among 3178 ( 25 % female ) consecutive ACS patients who underwent PCI at Liverpool Hospital , Sydney from 2003 to 2010 , using femoral access in 98 % of cases , we determined late events including mortality , myocardial infa rct ion and bleeding according to Bleeding Academic Research Consortium ( BARC ) criteria . RESULTS Females compared with males were older ( median 68 vs. 60 years ; p<0.001 ) , and were more likely to have diabetes ( 30 % vs. 22 % p<0.001 ) , hypertension ( 62 % vs. 49 % , p<0.001 ) , anaemia ( 26 % vs. 15 % , p<0.001 ) , and renal impairment ( 43 % vs. 20 % , p<0.001 ) ; they were more likely to be non-smokers ( 19 % vs. 30 % , p<0.001 ) . Females had less class B2/C lesions ( 64 % vs.68 % , p=0.048 ) , but had more calcified lesions ( 20 % vs. 11 % , p<0.001 ) , and smaller stent diameters ( 2.75[2.5 - 3.0 ] vs. 3.0[2.75 - 3.5 ] mm , p<0.001 ) . Females had higher three-year mortality rates ( 11 % vs. 7.0 % , p=0.001 ) , and more type 2 - 5 BARC bleeding post-PCI ( 22 % vs. 16 % , p=0.003 ) . Among patients under 55 years ( n=988 ) , mortality and bleeding were higher in females ( 6.0 % vs. 3.0 % , p=0.028 ) and ( 26 % vs. 14 % , p=0.001 ) respectively . There was no effect of gender on mortality or bleeding in patients 55 years and over . However , on multivariable stepwise regression analysis , female gender was not an independent predictor of mortality , but was a significant predictor of bleeding ( OR=1.84 [ 95 % CI:1.38 - 2.45 ] , p<0.001 ) . CONCLUSION Bleeding and mortality were higher in younger females with ACS who underwent PCI . While females had more post-PCI bleeding events , which were associated with late mortality , gender per se was not an independent predictor for mortality There are conflicting reports in the literature regarding the role of sex on the in-hospital mortality of patients with acute myocardial infa rct ion . The objective of this study is to determine whether there are gender differences in in-hospital mortality and angiographic findings of patients with acute ST-segment elevation myocardial infa rct ion ( STEMI ) undergoing percutaneous coronary intervention ( PCI ) . We conducted a prospect i ve study of all patients admitted to University Hospital Center Split , Croatia with STEMI from 2004 to 2008 who underwent PCI . From March 2004 throughout September 2008 , 488 patients with STEMI underwent PCI ( 364 men , 74.6 % ; 124 women , 25.4 % ) . Compared with men , women were significantly older ( mean age , 67.3 vs. 60.3 years ; p < 0.001 ) . Men had a significantly higher proportion of circumflex artery occlusion ( 19.5 % vs. 10.5 % , p = 0.022 ) . A higher proportion of men had a multivessel disease than women ( 56.8 % vs. 41.9 % ; p = 0.004 ) . In-hospital mortality was significantly higher among women ( 11.3 % vs. 4.6 % ; p = 0.002 ) but after adjustment for the baseline difference in age , the female sex was not an independent predictor of in-hospital mortality ( adjusted OR 1.15 ; 95 % CI 0.82 - 1.84 ) . In men , occlusions of left anterior descending artery showed higher mortality rate than occlusions of other coronary arteries ( LM 0 % , LAD 7.3 % , Cx 2.8 % , RCA 0.7 % , p = 0.03 ) . According to our results female gender is not an independent predictor of in-hospital mortality after percutaneous coronary intervention . In men , occlusions of left anterior descending arteries are associated with higher mortality rate comparing to occlusions of other coronary arteries Women with non-ST-elevation acute coronary syndromes ( NSTACSs ) may have better outcomes than men , but the effect of NSTACSs in women undergoing percutaneous coronary intervention ( PCI ) has not been examined . We performed a prospect i ve , multicenter , cohort study of consecutive patients who underwent PCI for NSTACS and stable angina during 3 National Heart , Lung , and Blood Institute Dynamic Registry recruitment waves ( 1997 to 2002 ) to examine the effect of female gender on adverse clinical events after PCI or stable angina for NSTACS . The primary end point was the combined rate of death , myocardial infa rct ion , or rehospitalization for cardiac causes at 1 year . Compared with men with NSTACS ( n = 2,124 ) , women ( n = 1,338 ) were older and more often had hypertension , diabetes mellitus , and history of heart failure ( p < 0.001 for all ) , whereas multivessel disease was less frequent ( p < 0.01 ) . Procedural success and in-hospital adverse event rates were similar . Women with NSTACS had the highest 1-year rate of death/myocardial infa rct ion/cardiac rehospitalization compared with women with stable angina pectoris ( n = 462 ) or men ( n = 995 ; women with NSTACS 37.6 % , men with NSTACS 29.8 % , women with stable angina 29.4 % , men with stable angina 27.7 % , p < 0.001 ) . The higher rate remained after adjustment for differences in baseline characteristics ( adjusted hazard ratio 1.37 , 95 % confidence interval 1.20 to 1.56 ) . Among women , NSTACS conferred a significantly higher risk for adverse events compared with stable angina ( adjusted hazard ratio 1.41 , p = 0.001 ) , whereas the risk of adverse events was not different in men ( adjusted hazard ratio 1.05 , p = 0.5 ) . In conclusion , women undergoing PCI for NSTACS have a higher risk of major adverse cardiac events than men or women undergoing PCI for stable angina The incidence of adverse outcomes after percutaneous coronary intervention ( PCI ) is higher in women than in men . Statins reduce the likelihood of cardiovascular events arising in patients with coronary artery disease ( CAD ) , but the impact of gender difference on long-term outcomes of PCI for CAD under statin treatment has not been established . We prospect ively enrolled 3,580 consecutive patients with CAD who were treated by PCI at our institution between 2000 and 2011 . Among these , 2,009 ( 43.9 % ; male , n = 1619 ; female , n = 390 ) were under statin therapy at the time of PCI . We evaluated the incidence of major adverse cardiac events ( MACE ) including all-cause death and acute coronary syndrome ( ACS ) . Age was significantly more advanced and the prevalences of hypertension and chronic kidney disease were higher among the female , than the male patients . Low-density lipoprotein cholesterol levels were significantly higher in women than in men ( 111.5 ± 38.9 vs. 107.5 ± 3 3.9 mg/dL , p = 0.04 ) . During a median follow-up period of 6.3 years , MACE that occurred in 336 ( 16.7 % ) patients included 206 ( 10.2 % ) with all-cause death and 154 ( 7.7 % ) with ACS . The cumulative rate of MACE tended to be higher in women than in men but the difference did not reach significance ( 19.7 vs. 16.0 % ; p = 0.08 , log-rank test ) . Multivariable Cox regression analysis showed that being female was not associated with MACE after adjusting for age ( HR 1.22 ; 95 % CI 0.94–1.57 ; p = 0.13 ) and other variables ( HR 1.14 ; 95 % CI 0.86–1.49 ; p = 0.35 ) . Long-term clinical outcomes were comparable between male and female patients with coronary artery disease who were administered with statins and underwent PCI even though the baseline characteristics were worse among the females The present study assessed the impact of early administration of abciximab in female and male patients with ST-segment elevation myocardial infa rct ion ( STEMI ) transferred for primary angioplasty ( PPCI ) . Data were gathered for 1,650 consecutive patients with STEMI transferred for PPCI from hospital networks in seven countries in Europe from November 2005 to January 20
Output:
| Conclusions : The systematic review and meta- analysis suggests that the prognosis of male patients with coronary artery disease after percutaneous coronary intervention is better than that of females , except for long-term revascularization |
MS213521 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Summary Background When cure is impossible , cancer treatment should focus on both length and quality of life . Maximisation of time without toxic effects could be one effective strategy to achieve both of these goals . The COIN trial assessed preplanned treatment holidays in advanced colorectal cancer to achieve this aim . Methods COIN was a r and omised controlled trial in patients with previously untreated advanced colorectal cancer . Patients received either continuous oxaliplatin and fluoropyrimidine combination ( arm A ) , continuous chemotherapy plus cetuximab ( arm B ) , or intermittent ( arm C ) chemotherapy . In arms A and B , treatment continued until development of progressive disease , cumulative toxic effects , or the patient chose to stop . In arm C , patients who had not progressed at their 12-week scan started a chemotherapy-free interval until evidence of disease progression , when the same treatment was restarted . R and omisation was done central ly ( via telephone ) by the MRC Clinical Trials Unit using minimisation . Treatment allocation was not masked . The comparison of arms A and B is described in a companion paper . Here , we compare arms A and C , with the primary objective of establishing whether overall survival on intermittent therapy was non-inferior to that on continuous therapy , with a predefined non-inferiority boundary of 1·162 . Intention-to-treat ( ITT ) and per- protocol analyses were done . This trial is registered , IS RCT N27286448 . Findings 1630 patients were r and omly assigned to treatment groups ( 815 to continuous and 815 to intermittent therapy ) . Median survival in the ITT population ( n=815 in both groups ) was 15·8 months ( IQR 9·4–26·1 ) in arm A and 14·4 months ( 8·0–24·7 ) in arm C ( hazard ratio [ HR ] 1·084 , 80 % CI 1·008–1·165 ) . In the per- protocol population ( arm A , n=467 ; arm C , n=511 ) , median survival was 19·6 months ( 13·0–28·1 ) in arm A and 18·0 months ( 12·1–29·3 ) in arm C ( HR 1·087 , 0·986–1·198 ) . The upper limits of CIs for HRs in both analyses were greater than the predefined non-inferiority boundary . Preplanned subgroup analyses in the per- protocol population showed that a raised baseline platelet count , defined as 400 000 per μL or higher ( 271 [ 28 % ] of 978 patients ) , was associated with poor survival with intermittent chemotherapy : the HR for comparison of arm C and arm A in patients with a normal platelet count was 0·96 ( 95 % CI 0·80–1·15 , p=0·66 ) , versus 1·54 ( 1·17–2·03 , p=0·0018 ) in patients with a raised platelet count ( p=0·0027 for interaction ) . In the per- protocol population , more patients on continuous than on intermittent treatment had grade 3 or worse haematological toxic effects ( 72 [ 15 % ] vs 60 [ 12 % ] ) , whereas nausea and vomiting were more common on intermittent treatment ( 11 [ 2 % ] vs 43 [ 8 % ] ) . Grade 3 or worse peripheral neuropathy ( 126 [ 27 % ] vs 25 [ 5 % ] ) and h and –foot syndrome ( 21 [ 4 % ] vs 15 [ 3 % ] ) were more frequent on continuous than on intermittent treatment . Interpretation Although this trial did not show non-inferiority of intermittent compared with continuous chemotherapy for advanced colorectal cancer in terms of overall survival , chemotherapy-free intervals remain a treatment option for some patients with advanced colorectal cancer , offering reduced time on chemotherapy , reduced cumulative toxic effects , and improved quality of life . Subgroup analyses suggest that patients with normal baseline platelet counts could gain the benefits of intermittent chemotherapy without detriment in survival , whereas those with raised baseline platelet counts have impaired survival and quality of life with intermittent chemotherapy and should not receive a treatment break . Funding Cancer Research UK PURPOSE To compare the efficacy of cediranib ( a vascular endothelial growth factor receptor tyrosine kinase inhibitor [ VEGFR TKI ] ) with that of bevacizumab ( anti-VEGF-A monoclonal antibody ) in combination with chemotherapy as first-line treatment for advanced metastatic colorectal cancer ( mCRC ) . PATIENTS AND METHODS HORIZON III [ Cediranib Plus FOLFOX6 Versus Bevacizumab Plus FOLFOX6 in Patients With Untreated Metastatic Colorectal Cancer ] had an adaptive phase II/III design . Patients r and omly assigned 1:1:1 received mFOLFOX6 [ oxaliplatin 85 mg/m(2 ) and leucovorin 400 mg/m(2 ) intravenously followed by fluorouracil 400 mg/m(2 ) intravenously on day 1 and then continuous infusion of 2,400 mg/m(2 ) over the next 46 hours every 2 weeks ] with cediranib ( 20 or 30 mg per day ) or bevacizumab ( 5 mg/kg every 14 days ) . An independent end-of-phase II analysis concluded that mFOLFOX6/cediranib 20 mg met predefined criteria for continuation ; subsequent patients received mFOLFOX6/cediranib 20 mg or mFOLFOX6/bevacizumab ( r and omly assigned 1:1 ) . The primary objective was to compare progression-free survival ( PFS ) . RESULTS In all , 1,422 patients received mFOLFOX6/cediranib 20 mg ( n = 709 ) or mFOLFOX6/bevacizumab ( n = 713 ) . Primary analysis revealed no significant difference between arms for PFS ( hazard ratio [ HR ] , 1.10 ; 95 % CI , 0.97 to 1.25 ; P = .119 ) , overall survival ( OS ; HR , 0.95 ; 95 % CI , 0.82 to 1.10 ; P = .541 ) , or overall response rate ( 46.3 % v 47.3 % ) . Median PFS and OS were 9.9 and 22.8 months for mFOLFOX6/cediranib and 10.3 and 21.3 months for mFOLFOX6/bevacizumab . The PFS upper 95 % CI was outside the predefined noninferiority limit ( HR < 1.2 ) . Common adverse events with more than 5 % incidence in the cediranib arm included diarrhea , neutropenia , and hypertension . Cediranib-treated patients completed fewer chemotherapy cycles than bevacizumab-treated patients ( median 10 v 12 cycles ) . Patient-reported outcomes ( PROs ) were significantly less favorable in cediranib-treated versus bevacizumab-treated patients ( P < .001 ) . CONCLUSION Cediranib activity , in terms of PFS and OS , was comparable to that of bevacizumab when added to mFOLFOX6 ; however , the predefined boundary for PFS noninferiority was not met . The cediranib safety profile was consistent with previous studies but led to less favorable PROs compared with bevacizumab . Investigation of oral TKIs in CRC continues BACKGROUND Cetuximab , an IgG1 chimeric monoclonal antibody against epidermal growth factor receptor ( EGFR ) , has activity against colorectal cancers that express EGFR . METHODS From December 2003 to August 2005 , 572 patients who had colorectal cancer expressing immunohistochemically detectable EGFR and who had been previously treated with a fluoropyrimidine , irinotecan , and oxaliplatin or had contraindications to treatment with these drugs underwent r and omization to an initial dose of 400 mg of cetuximab per square meter of body-surface area followed by a weekly infusion of 250 mg per square meter plus best supportive care ( 287 patients ) or best supportive care alone ( 285 patients ) . The primary end point was overall survival . RESULTS In comparison with best supportive care alone , cetuximab treatment was associated with a significant improvement in overall survival ( hazard ratio for death , 0.77 ; 95 % confidence interval [ CI ] , 0.64 to 0.92 ; P=0.005 ) and in progression-free survival ( hazard ratio for disease progression or death , 0.68 ; 95 % CI , 0.57 to 0.80 ; P<0.001 ) . These benefits were robust after adjustment in a multivariable Cox proportional-hazards model . The median overall survival was 6.1 months in the cetuximab group and 4.6 months in the group assigned to supportive care alone . Partial responses occurred in 23 patients ( 8.0 % ) in the cetuximab group but in none in the group assigned to supportive care alone ( P<0.001 ) ; the disease was stable in an additional 31.4 % of patients assigned to cetuximab and in 10.9 % of patients assigned to supportive care alone ( P<0.001 ) . Quality of life was better preserved in the cetuximab group , with less deterioration in physical function and global health status scores ( both P<0.05 ) . Cetuximab treatment was associated with a characteristic rash ; a rash of grade 2 or higher was strongly associated with improved survival ( hazard ratio for death , 0.33 ; 95 % CI , 0.22 to 0.50 ; P<0.001 ) . The incidence of any adverse event of grade 3 or higher was 78.5 % in the cetuximab group and 59.1 % in the group assigned to supportive care alone ( P<0.001 ) . CONCLUSIONS Cetuximab improves overall survival and progression-free survival and preserves quality -of-life measures in patients with colorectal cancer in whom other treatments have failed . ( Clinical Trials.gov number , NCT00079066 [ Clinical Trials.gov ] . ) BACKGROUND The optimum use of cytotoxic drugs for advanced colorectal cancer has not been defined . Our aim was to investigate whether combination treatment is better than the sequential administration of the same drugs in patients with advanced colorectal cancer . METHODS In this open-label , r and omised , phase 3 trial , we r and omly assigned patients ( 1:1 ratio ) with advanced , measurable , non-resectable colorectal cancer and WHO performance status 0 - 2 to receive either first-line treatment with bolus ( 400 mg/m(2 ) ) and infusional ( 2400 mg/m(2 ) ) fluorouracil plus leucovorin ( 400 mg/m(2 ) ) ( simplified LV5FU2 regimen ) , second-line LV5FU2 plus oxaliplatin ( 100 mg/m(2 ) ) ( FOLFOX6 ) , and third-line LV5FU2 plus irinotecan ( 180 mg/m(2 ) ) ( FOLFIRI ) or first-line FOLFOX6 and second-line FOLFIRI . Chemotherapy was administered every 2 weeks . R and omisation was done central ly using minimisation ( minimisation factors were WHO performance status , previous adjuvant chemotherapy , number of disease sites , and centre ) . The primary endpoint was progression-free survival after two lines of treatment . Analyses were by intention-to-treat . This trial is registered at Clinical Trials.gov , NCT00126256 . FINDINGS 205 patients were r and omly assigned to the sequential group and 205 to the combination group . 161 ( 79 % ) patients in the sequential group and 161 ( 79 % ) in the combination group died during the study . Median progression-free survival after two lines was 10·5 months ( 95 % CI 9·6 - 11·5 ) in the sequential group and 10·3 months ( 9·0 - 11·9 ) in the combination group ( hazard ratio 0·95 , 95 % CI 0·77 - 1·16 ; p=0·61 ) . All six deaths caused by toxic effects of treatment occurred in the combination group . During first-line chemotherapy , significantly fewer severe ( grade 3 - 4 ) haematological adverse events ( 12 events in 203 patients in sequential group vs 83 events in 203 patients in combination group ; p<0·0001 ) and non-haematological adverse events ( 26 events vs 186 events ; p<0·0001 ) occurred in the sequential group than in the combination group . INTERPRETATION Upfront combination chemotherapy is more toxic and is not more effective than the sequential use of the same cytotoxic drugs in patients with advanced , non-resectable colorectal cancer . FUNDING Sanofi-Aventis France PURPOSE To determine whether irinotecan plus oxaliplatin ( mIROX ) is superior to irinotec
Output:
| RESULTS Analysis of 33 trials reporting treatment effects on all three outcomes showed reasonably strong association between treatment effects on PFS and OS , however the association parameters were obtained with a large uncertainty .
A weak surrogate relationship was noted between the treatment effects on TR and OS .
Modelling the two surrogate endpoints , TR and PFS , jointly as predictors of treatment effect on OS gave no marked improvement to surrogate association patterns .
Modest improvement in the precision of the predicted treatment effects on the final outcome was noted in studies investigating anti-angiogenic therapy , however it was likely due to chance .
The joint use of two surrogate endpoints did not lead to marked improvement in the association between treatment effects on surrogate and final endpoints in advanced colorectal cancer |
MS213522 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE The International Prognostic Index ( IPI ) is widely used for risk stratification of patients with aggressive B-cell lymphoma . The introduction of rituximab has markedly improved outcome , and R-CHOP ( rituximab + cyclophosphamide , doxorubicin , vincristine , prednisone ) has become the st and ard treatment for CD20(+ ) diffuse large B-cell lymphoma . To investigate whether the IPI has maintained its power for risk stratification when rituximab is combined with CHOP , we analyzed the prognostic relevance of IPI in three prospect i ve clinical trials . PATIENTS AND METHODS In total , 1,062 patients treated with rituximab were included ( MabThera International Trial [ MInT ] , 380 patients ; dose-escalated regimen of cyclophosphamide , doxorubicin , vincristine , etoposide , and prednisone ( MegaCHOEP ) trial , 72 patients ; CHOP + rituximab for patients older than age 60 years [ RICOVER-60 ] trial , 610 patients ) . A multivariate proportional hazards modeling was performed for single IPI factors under rituximab on event-free , progression-free , and overall survival . RESULTS IPI score was significant for all three end points . Rituximab significantly improved treatment outcome within each IPI group result ing in a quenching of the Kaplan-Meier estimators . However , IPI was a significant prognostic factor in all three end points and the ordering of the IPI groups remained valid . The relative risk estimates of single IPI factors and their order in patients treated with R-CHOP were similar to those found with CHOP . CONCLUSION The effects of rituximab were superimposed on the effects of CHOP with no interactions between chemotherapy and antibody therapy . These results demonstrate that the IPI is still valid in the R-CHOP era BACKGROUND High-dose therapy ( HDT ) followed by transplantation of autologous haemopoietic stem cells is frequently done as part of first-line therapy in young patients with high-risk aggressive B-cell lymphoma . We investigated whether HDT with cytotoxic agents identical to those used for conventional therapy followed by autologous stem-cell transplantation ( ASCT ) improved survival outcome compared with conventional chemotherapy when rituximab was added to both modalities . METHODS We did an open-label , r and omised trial comparing conventional chemotherapy ( cyclophosphamide , doxorubicin , vincristine , etoposide , prednisone ) and rituximab ( R-CHOEP-14 ) with dose-escalated sequential HDT and rituximab ( R-MegaCHOEP ) followed by repetitive ASCT in high-risk ( age-adjusted International Prognostic Index [ IPI ] 2 or 3 ) patients aged 18 - 60 years with aggressive B-cell lymphoma . Eligible patients received radiotherapy for bulky , extranodal disease , or both . R and omisation ( 1:1 ) used the Pocock minimisation algorithm ; patients were stratified by age-adjusted IPI factors , bulky disease , and centre . The primary endpoint was event-free survival . All analyses were done on the intention-to-treat population . This trial is registered with Clinical Trials.gov , number NCT00129090 . FINDINGS 136 patients were r and omly assigned to R-CHOEP-14 and 139 to R-MegaCHOEP . 130 patients in the R-CHOEP-14 group and 132 in the R-MegaCHOEP group were included in the intention-to-treat population . After a median of 42 months ( IQR 29 - 59 ) , 3-year event-free survival was 69·5 % ( 95 % CI 61·3 - 77·7 ) in the R-CHOEP-14 group and 61·4 % ( 52·8 - 70·0 ) in the R-MegaCHOEP group ( p=0·14 ; hazard ratio 1·3 , 95 % CI 0·9 - 2·0 ) . All 128 evaluable patients treated with R-MegaCHOEP had grade 4 leucopenia , as did 48 ( 58·5 % ) of 82 patients with documented blood counts in the R-CHOEP-14 group . All 128 evaluable patients in the R-MegaCHOEP group had grade 3 - 4 thrombocytopenia , as did 26 ( 33·8 % ) of 77 patients in the R-CHOEP-14 group with documented blood counts . The most important non-haematological grade 3 or 4 adverse event was infection , which occurred in 96 ( 75·0 % ) of 128 patients treated with R-MegaCHOEP and in 40 ( 31·3 % ) of 128 patients treated with R-CHOEP-14 . INTERPRETATION In young patients with high-risk aggressive B-cell lymphoma , R-MegaCHOEP was not superior to conventional R-CHOEP therapy and was associated with significantly more toxic effects . R-CHOEP-14 with or without radiotherapy remains a treatment option for these patients , with encouraging efficacy . FUNDING Deutsche Krebshilfe PURPOSE Salvage chemotherapy followed by high-dose therapy and autologous stem-cell transplantation ( ASCT ) is the st and ard treatment for relapsed diffuse large B-cell lymphoma ( DLBCL ) . Salvage regimens have never been compared ; their efficacy in the rituximab era is unknown . PATIENTS AND METHODS Patients with CD20(+ ) DLBCL in first relapse or who were refractory after first-line therapy were r and omly assigned to either rituximab , ifosfamide , etoposide , and carboplatin ( R-ICE ) or rituximab , dexamethasone , high-dose cytarabine , and cisplatin ( R-DHAP ) . Responding patients received high-dose chemotherapy and ASCT . RESULTS The median age of the 396 patients enrolled ( R-ICE , n = 202 ; R-DHAP , n = 194 ) was 55 years . Similar response rates were observed after three cycles of R-ICE ( 63.5 % ; 95 % CI , 56 % to 70 % ) and R-DHAP ( 62.8 % ; 95 CI , 55 % to 69 % ) . Factors affecting response rates ( P < .001 ) were refractory disease/relapse less than versus more than 12 months after diagnosis ( 46 % v 88 % , respectively ) , International Prognostic Index ( IPI ) of more than 1 versus 0 to 1 ( 52 % v 71 % , respectively ) , and prior rituximab treatment versus no prior rituximab ( 51 % v 83 % , respectively ) . There was no significant difference between R-ICE and R-DHAP for 3-year event-free survival ( EFS ) or overall survival . Three-year EFS was affected by prior rituximab treatment versus no rituximab ( 21 % v 47 % , respectively ) , relapse less than versus more than 12 months after diagnosis ( 20 % v 45 % , respectively ) , and IPI of 2 to 3 versus 0 to 1 ( 18 % v 40 % , respectively ) . In the Cox model , these parameters were significant ( P < .001 ) . CONCLUSION In patients who experience relapse more than 12 months after diagnosis , prior rituximab treatment does not affect EFS . Patients with early relapses after rituximab-containing first-line therapy have a poor prognosis , with no difference between the effects of R-ICE and R-DHAP 18F-fluorodeoxyglucose positron emission tomography ( FDG-PET ) documented response after salvage chemotherapy has been reported to impact survival in patients with aggressive non-Hodgkin ’s lymphoma , especially diffuse large B cell lymphoma ( DLBCL ) undergoing high dose chemotherapy and autologous SCT ( HDC auto-SCT ) . We review ed the impact of 19 different prognostic/predictive factors before salvage chemotherapy and post-salvage chemotherapy FDG-PET results in patients with aggressive lymphoma and developed an FDG-PET integrated model for post-HDC auto-SCT outcome . The Fine and Gray method for competing risk analysis and a regression model was used to assess the risk associated with different factors on outcome . Fifty-five patients had FDG-PET after salvage chemotherapy ; male 65 % , female 45 % , relapsed 55 % , refractory 45 % , DLBCL 82 % , T cell lymphoma 18 % , median age at auto-SCT 40 years , median follow-up 42.4 months . Multivariate analysis identified only positive FDG-PET ( P=0.04 ) and mediastinal involvement ( P=0.05 ) with higher hazard rate of disease-specific death ( model P=0.008 ) but only positive FDG-PET ( P=0.01 ) for disease-specific events ( persistent , progressive or relapsed disease ) . Cumulative incidence of disease-specific death for patients with 0 , 1 and 2 risk factors was 5 , 30 and 62 % , respectively ( P=0.01 ) . Our model is significant and showed an increasing risk of failure with mediastinal involvement and post-salvage positive FDG-PET BACKGROUND High-dose chemotherapy followed by autologous bone marrow transplantation is a therapeutic option for patients with chemotherapy-sensitive non-Hodgkin 's lymphoma who have relapses . In this report we describe a prospect i ve r and omized study of such treatment . METHOD A total of 215 patients with relapses of non-Hodgkin 's lymphoma were treated between July 1987 and June 1994 . All patients received two courses of conventional chemotherapy . The 109 patients who had a response to chemotherapy were r and omly assigned to receive four courses of chemotherapy plus radiotherapy ( 54 patients ) or radiotherapy plus intensive chemotherapy and autologous bone marrow transplantation ( 55 patients ) . RESULTS The overall rate of response to conventional chemotherapy was 58 percent ; among patients with relapses after chemotherapy , the response rate was 64 percent , and among those with relapses during chemotherapy , the response rate was 21 percent . There were three deaths from toxic effects among the patients in the transplantation group , and none among those in the group receiving chemotherapy without transplantation . The two groups did not differ in terms of prognostic factors . The median follow-up time was 63 months . The response rate was 84 percent after bone marrow transplantation and 44 percent after chemotherapy without transplantation . At five years , the rate of event-free survival was 46 percent in the transplantation group and 12 percent in the group receiving chemotherapy without transplantation ( P = 0.001 ) , and the rate of overall survival was 53 and 32 percent , respectively ( P = 0.038 ) . CONCLUSIONS As compared with conventional chemotherapy , treatment with high-dose chemotherapy and autologous bone marrow transplantation increases event-free and overall survival in patients with chemotherapy-sensitive non-Hodgkin 's lymphoma in relapse Second-line chemotherapy followed by high-dose therapy ( HDT ) with autologous stem cell transplantation ( ASCT ) cures less than half of the patients with relapsed or refractory diffuse large B-cell lymphoma ( DLBCL ) . Prognostic models capable of predicting outcome are essential . In 3 sequential clinical trials , conducted from January 1993 to August 2000 , we treated 150 patients with relapsed or primary refractory DLBCL with ifosfamide , carboplatin , and etoposide ( ICE ) chemotherapy followed by HDT/ASCT for patients with chemosensitive disease . We evaluated the age-adjusted International Prognostic Index at the initiation of second-line therapy ( sAAIPI ) as a predictor of progression-free survival ( PFS ) and overall survival ( OS ) . At a median follow-up of 4 years , the PFS and OS are 28 % and 34 % by intention to treat and 39 % and 45 % for only those patients with chemosensitive disease . Three risk groups with different PFS and OS were identified by the sAAIPI : low risk ( 0 factors ) , 70 % and 74 % ; intermediate risk ( 1 factor ) , 39 % and 49 % ; and high risk ( 2 or 3 factors ) , 16 % and 18 % ( P < .001 for both PFS and OS ) . The sAAIPI also predicts the PFS and OS for patients with ICEchemosensitive disease : low risk , 69 % and 83 % ; intermediate risk , 46 % and 55 % ; and high risk , 25 % and 26 % ( P < .001 PFS and OS ) . The sAAIPI predicts outcome for patients with relapsed or primary refractory DLBCL in both intent-to-treat and chemosensitive population s. This powerful prognostic instrument should be used to evaluate new treatment approaches and to compare results of different regimens Allogeneic SCT is an effective therapy for lymphoma . Reduced-intensity conditioning ( RIC )
Output:
| At present , pretransplant FDG-PET can not be recommended in aggressive non-Hodgkin lymphoma , because available studies suffer from major method ological flaws , and reported prognostic estimates are low ( i.e. , poor in newly diagnosed and moderate in refractory/relapsed aggressive non-Hodgkin lymphoma ) |
MS213523 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives : To investigate whether a modest number of food frequency questions are sufficient to describe sociodemographic differences in dietary habits , and to identify sociodemographic characteristics of subjects adhering to food-based dietary guidelines operationalised in a ‘ healthy-diet index ’ . Design : Cross-sectional population survey . Subjects : A total of 480 men , 515 women , aged 15–90 y. R and om sample of private telephone numbers drawn from regional telephone records , geographically stratified . Participation rate 62 % . Methods : Computer-assisted telephone interviews , including six food frequency questions , a question on type of fat spreads used on bread , questions on seven sociodemographic variables . Results : The summary of the healthy-diet index showed that the subjects who adhered to food-based dietary guidelines ( top quintile ) compared to those who did not ( bottom quintile ) were most often women ( odds ratio (OR)=6.07 ; confidence interval ( CI ) : 3.91–9.43 , women vs men ) , of older age ( OR=9.72 ; CI : 3.02–31.31 , old age vs young ) , highly educated ( OR=3.69 ; CI : 1.53–8.92 , high education vs low ) and living in multiperson households including children ( OR=4.66 ; CI : 2.47–8.80 , multiperson household vs single household ) . The results also showed that gender difference in dietary habits is associated with other sociodemographic variables . Conclusions : The selected food frequency questions proved sufficient to describe sociodemographic differences in dietary habits , and this method may be a valuable supplement to traditional quantitative dietary surveys in monitoring sociodemographic changes in eating patterns . The results also underline the influence of sociodemographic status on dietary habits . Sponsorship : The Danish Nutrition Council funded the study Background Vegetarian diets have been associated with lower risk of chronic disease , but little is known about the health effects of low meat diets and the reliability of self-reported vegetarian status . We aim ed to establish an analytical cohort over-represented with vegetarians , pescetarians and 1 day/week meat consumers , and to describe their lifestyle and dietary characteristics . In addition , we were able to compare self-reported vegetarians with vegetarians whose status has been confirmed by their response on the extensive food frequency question naire ( FFQ ) . Study methods Embedded within the Netherl and s Cohort Study ( n = 120,852 ; including 1150 self-reported vegetarians ) , the NLCS-Meat Investigation Cohort ( NLCS-MIC ) was defined by combining all FFQ-confirmed-vegetarians ( n = 702 ) , pescetarians ( n = 394 ) , and 1 day/week meat consumers ( n = 1,396 ) from the total cohort with a r and om sample of 2–5 days/week- and 6–7 days/week meat consumers ( n = 2,965 and 5,648 , respectively ) . Results Vegetarians , pescetarians , and 1 day/week meat consumers had more favorable dietary intakes ( e.g. higher fiber/vegetables ) and lifestyle characteristics ( e.g. lower smoking rates ) compared to regular meat consumers in both sexes . Vegetarians adhered to their diet longer than pescetarians and 1 day/week meat consumers . 75 % of vegetarians with a prevalent cancer at baseline had changed to this diet after diagnosis . 50 % of self-reported vegetarians reported meat or fish consumption on the FFQ . Although the misclassification that occurred in terms of diet and lifestyle when merely relying on self-reporting was relatively small , the impact on associations with disease risk remains to be studied . Conclusion We established an analytical cohort over-represented with persons at the lower end of the meat consumption spectrum which should facilitate prospect i ve studies of major cancers and causes of death using ≥20.3 years of follow-up The effects on pregnancy outcome and maternal iron status of powdered milk ( PUR ) and a milk-based fortified product ( V-N ) were compared in a group of underweight gravidas . These take-home products were distributed during regular prenatal visits . Women in the V-N group had greater weight gain ( 12.29 vs 11.31 kg , p less than 0.05 ) and mean birth weights ( 3178 vs 3105 g , p less than 0.05 ) than those in the PUR group . Values for various indicators of maternal Fe status were also higher in the V-N group . Compared with self-selected noncompliers , similar in all control variables to compliers , children of women who consumed powdered milk or the milk-based fortified product had mean birth weights that were higher by 258 and 335 g , respectively . Data indicate a beneficial effect of the fortified product on both maternal nutritional status and fetal growth The effect of increasing dietary folate on folate status during pregnancy is controversial . The aim of this study was to compare folate intake and folate status during pregnancy of women with high long-term vegetable intake and those eating an average Western diet . In a prospect i ve study that included 109 participants , pregnant women adhering to a predominant vegetarian diet with high vegetable intake for 8 + /- 0.5 y with subgroups of ovo-lacto vegetarians ( n = 27 ) and low meat eaters ( n = 43 ) and women eating an average Western diet ( control group , n = 39 ) were compared with regard to dietary intake and plasma and red blood cell ( RBC ) folate concentrations during wk 9 - 12 , 20 - 22 and 36 - 38 of gestation . Plasma and RBC folate concentrations were highest in ovo-lacto vegetarians , followed by low meat eaters and lowest in the controls . Ovo-lacto vegetarians and low meat eaters showed a lower risk for folate deficiency , with RBC folate concentrations of < 320 nmol/L result ing in odds ratios of 0.10 ( 95 % confidence interval , 0.01 - 0.56 ) and 0.52 ( 95 % confidence interval , 0.20 - 1.34 ) , respectively . In ovo-lacto vegetarians , the RBC folate concentration was positively related to the intake of vitamin B-12 ( r = 0.51 , P : < 0.0001 ) . The results of the study suggest that long-term high vegetable intake favorably affects plasma folate as well as RBC folate concentrations throughout pregnancy and reduces the risk of folate deficiency if an adequate vitamin B-12 supply is ensured This study is a r and omized controlled double-blind trial on the effects of nutrition supplement of pregnant and lactating women on their offspring . The study was conducted by the late Dr. Bacon Chow in 14 villages in Sui-Lin township , a farming area about 180 miles from Taipei , Taiwan . Two hundred ninety-four women were r and omly assigned to one of two treatment groups . The daily supplement for one group provided 800 kcal and 40 g of protein/day ; for the other group it only provided 80 kcal/day . Supplementation began after 3 wk of the delivery of a first study infant , continued throughout lactation , and through the pregnancy and lactation of a second study infant . Between group comparisons on the birth weight , number of low birth weight infants , or incidence of fetal deaths showed no statistically significant findings . However , the birth weight of the second study infant was statistically different and higher than that of the first study infant in the high supplement group . Moreover , in the low supplement group there was a correlation of 0.22 ( p = 0.06 ) between the change scores for birth weight from the first to the second study infant and the quantity of supplements consumed during the last trimester of pregnancy . There was also in this same group a significant slope in a linear regression of birth weight on total daily caloric intake during the 3rd trimester of pregnancy for the male second study infants . These findings are partly in agreement with findings from three other large supplementation studies in Colombia , Guatemala , and New York . In this study the findings indicate that caloric supplementation does result in a small yet statistically meaningful increment in birth weight within a population which is not nutritionally at risk BACKGROUND Few data exist for the effects of multiple micronutrient ( MM ) or food supplementation to undernourished pregnant women on their offsprings ' development . OBJECTIVE We aim ed to compare the effects on infant development of early ( 8 - 10 wk gestation ) or usual ( approximately 17 wk gestation ) supplementation with food and MM , 30 mg Fe + 400 microg folate , or 60 mg Fe + 400 microg folate . DESIGN A large , r and omized , controlled trial of pregnancy supplementation was conducted in Bangladesh . A sub sample of infants ( n = 2853 ) were assessed on 2 problem-solving tests ( support and cover tests ) , the motor index of the Bayley Scales of Infant Development , and Wolke 's behavior ratings at 7 mo of age . RESULTS There were no significant effects of any intervention in the group as a whole . However , infants of undernourished mothers [ body mass index ( BMI ; in kg/m2 ) < 18.5 ] who received early food supplementation performed slightly but significantly ( P = 0.035 ) better on the support test than did infants of mothers who received usual food supplementation ( z score : 0.17 ; 95 % CI : 0.01 , 0.33 ) . There were no benefits in infants of higher- BMI mothers ( P = 0.024 for BMI x food interaction ) . Children of low- BMI mothers who received MMs had slightly better motor scores ( z score : 0.28 ; 95 % CI : 0.08 , 0.48 ) and activity ratings ( z score : 0.24 ; 95 % CI : 0.037 , 0.45 ) than did those who received 30 mg Fe + 400 microg folate , whereas other children did not benefit ( P = 0.05 for both motor scores and BMI x micronutrients and for activity and BMI x micronutrients ) . CONCLUSIONS Small benefits from early food and MM supplementation were found in infants of low- BMI but not of high- BMI mothers . However , the benefits were of doubtful functional importance , and longer follow-up is required to determine programmatic implication BACKGROUND Iron deficiency during pregnancy is associated with adverse birth outcomes , particularly , if present during early gestation . Iron supplements are widely recommended during pregnancy , but evidence of their benefit in relation to infant outcomes is not established . This study was performed in the UK , where iron supplements are not routinely recommended during pregnancy , to investigate the association between iron intake in pregnancy and size at birth . METHODS From a prospect i ve cohort of 1274 pregnant women aged 18–45 years , dietary intake was reported in a 24-h recall administered by a research midwife at 12-week gestation . Dietary supplement intake was ascertained using dietary recall and three question naires in the first , second and third trimesters . RESULTS Of the cohort of pregnant women , 80 % reported dietary iron intake below the UK Reference Nutrient Intake of 14.8 mg/day . Those reported taking iron-containing supplements in the first , second and third trimesters were 24 , 15 and 8 % , respectively . Women with dietary iron intake > 14.8 mg/day were more likely to be older , have a higher socioeconomic profile and take supplements during the first trimester . Vegetarians were less likely to have low dietary iron intake [ odds ratio = 0.5 , 95 % confidence interval ( CI ) : 0.4 , 0.8 ] and more likely to take supplements during the first and second trimesters . Total iron intake , but not iron intake from food only , was associated with birthweight centile ( adjusted change = 2.5 centiles/10 mg increase in iron , 95 % CI : 0.4 , 4.6 ) . This association was stronger in the high vitamin C intake group , but effect modification was not significant . CONCLUSION There was a positive relationship between total iron intake , from food and supplements , in early pregnancy and birthweight . Iron intake , both from diet and supplements , during the first trimester of pregnancy was higher in vegetarians and women with a better socioeconomic profile OBJECTIVES The purpose of this project was to develop a detailed , in-home , prenatal nutrition intervention protocol for low-income women and to assess the effectiveness of the intervention in improving their dietary intake . A secondary objective was to identify predictors of infant birth weight . DESIGN A defined protocol was developed and nutritionists followed it to conduct in-home nutrition sessions that included nutrition assessment , education , counseling , and goal setting for low-income women during their pregnancies . A pre/post design was used to assess the effects of the nutrition program on dietary intake . A control group was used in evaluating the effect of the nutrition intervention on birth weight . SUBJECTS/ SETTING Forty low-income pregnant women selected r and omly by the county health department nursing staff completed the nutrition intervention . Twenty-six women were also selected to serve as a control group . INTERVENTION For women in the intervention group , in-home visits were conducted weekly for 4 weeks , followed by 2 monthly visits . The purpose of the in-home visits was to use the defined
Output:
| The nine heterogeneous studies on microelements and vitamins suggest vegan-vegetarian women may be at risk of vitamin B12 and iron deficiencies . |
MS213524 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background —Tai Chi Chuan ( TTC ) exercise has beneficial effects on the components of physical condition and can produce a substantial reduction in the risk of multiple falls . Previous studies have shown that short term TCC exercise did not improve the scores in the single leg stance test with eyes closed and the sit and reach test . There has apparently been no research into the effects of TCC on total body rotation flexibility and heart rate responses at rest and after a three minute step test . Methods —In this cross sectional study , 28 male TCC practitioners with an average age of 67.5 years old and 13.2 years of TCC exercise experience were recruited to form the TCC group . Another 30 sedentary men aged 66.2 were selected to serve as the control group . Measurements included resting heart rate , left and right single leg stance with eyes closed , modified sit and reach test , total body rotation test ( left and right ) , and a three minute step test . Results —Compared with the sedentary group , the TCC group had significantly better scores in resting heart rate , three minute step test heart rate , modified sit and reach , total body rotation test on both right and left side ( p<0.01 ) , and both right and left leg st and ing with eyes closed ( p<0.05 ) . According to the American Fitness St and ards , the TCC group attained the 90th percentile rank for sit and reach and total body rotation test , right and left . Conclusion —Long term regular TCC exercise has favourable effects on the promotion of balance control , flexibility , and cardiovascular fitness in older adults Of 22 r and omized trials of rehabilitation with exercise after myocardial infa rct ion ( MI ) , one trial had results that achieved conventional statistical significance . To determine whether or not these studies , in the aggregate , show a significant benefit of rehabilitation after myocardial infa rct ion , we performed an overview of all r and omized trials , involving 4,554 patients ; we evaluated total and cardiovascular mortality , sudden death , and fatal and nonfatal reinfa rct ion . For each endpoint , we calculated an odds ratio ( OR ) and 95 % confidence interval ( 95 % CI ) for the trials combined . After an average of 3 years of follow-up , the ORs were significantly lower in the rehabilitation than in the comparison group : specifically , total mortality ( OR = 0.80 [ 0.66 , 0.96 ] ) , cardiovascular mortality ( OR = 0.78 [ 0.63 , 0.96 ] ) , and fatal reinfa rct ion ( OR = 0.75 [ 0.59 , 0.95 ] ) . The OR for sudden death was significantly lower in the rehabilitation than in the comparison group at 1 year ( OR = 0.63 [ 0.41 , 0.97 ] ) . The data were compatible with a benefit at 2 ( OR = 0.76 [ 0.54 , 1.06 ] ) and 3 years ( OR = 0.92 [ 0.69 , 1.23 ] ) , but these findings were not statistically significant . For nonfatal reinfa rct ion , there were no significant differences between the two groups after 1 ( OR = 1.09 [ 0.76 , 1.57 ] ) , 2 ( OR = 1.10 [ 0.82 , 1.47 ] ) , or 3 years ( OR = 1.09 [ 0.88 , 1.34 ] ) of follow-up . The observed 20 % reduction in overall mortality reflects a decreased risk of cardiovascular mortality and fatal reinfa rct ion throughout at least 3 years and a reduction in sudden death during the 1st year after infa rct ion and possibly for 2 - 3 years . With respect to the independent effects of the physical exercise component of cardiac rehabilitation , the relatively small number of " exercise only " trials , combined with the possibility that they may have had a formal or informal nonexercise component precludes the possibility of reaching any definitive conclusion . To do so would require a r and omized trial of sufficient size to distinguish between no effect and the most plausible effect based on the results of this overview Background Falls are a significant public health problem . Thirty to fifty percent of the elderly of 65 years and older fall each year . Falls are the most common type of accident in this age group and can result in fractures and subsequent disabilities , increased fear of falling , social isolation , decreased mobility , and even an increased mortality . Several forms of exercise have been associated with a reduced risk of falling and with a wide range of physiological as well as psychosocial health benefits . Tai Chi Chuan seems to be the most promising form of exercise in the elderly , but the evidence is still controversial . In this article the design of a r and omized clinical trial is presented . The trial evaluates the effect of Tai Chi Chuan on fall prevention and physical and psychological function in older adults . Methods / Design 270 people of seventy years and older living at home will be identified in the files of the participating general practitioners . People will be asked to participate when meeting the following inclusion criteria : have experienced a fall in the preceding year or suffer from two of the following risk factors : disturbed balance , mobility problems , dizziness , or the use of benzodiazepines or diuretics . People will be r and omly allocated to either the Tai Chi Chuan group ( 13 weeks , twice a week ) or the no treatment control group . The primary outcome measure is the number of new falls , measured with a diary . The secondary outcome measures are balance , fear of falling , blood pressure , heart rate , lung function parameters , physical activity , functional status , quality of life , mental health , use of walking devices , medication , use of health care services , adjustments to the house , severity of fall incidents and subsequent injuries . Process parameters will be measured to evaluate the Tai Chi Chuan intervention . A cost-effectiveness analysis will be carried out alongside the evaluation of the clinical results . Follow-up measurements will be collected at 3 , 6 and 12 months after r and omization . Discussion As far as we know this is the first trial in Europe considering Tai Chi Chuan and fall prevention . This project will answer a pragmatic research question regarding the efficacy of Tai Chi Chuan regarding fall reduction Older adults with type 2 diabetes have mobility impairment and reduced fitness . This study aim ed to test the efficacy of the “ Tai Chi for Diabetes ” form , developed to address health-related problems in diabetes , including mobility and physical function . Thirty-eight older adults with stable type 2 diabetes were r and omized to Tai Chi or sham exercise , twice a week for 16 weeks . Outcomes included gait , balance , musculoskeletal and cardiovascular fitness , self-reported activity and quality of life . Static and dynamic balance index ( −5.8 ± 14.2 ; p = 0.03 ) and maximal gait speed ( 6.2 ± 11.6 % ; p = 0.005 ) improved over time , with no significant group effects . There were no changes in other measures . Non-specific effects of exercise testing and /or study participation such as outcome expectation , socialization , the Hawthorne effect , or unmeasured changes in health status or compliance with medical treatment may underlie the modest improvements in gait and balance observed in this sham-exercise-controlled trial . This Tai Chi form , although developed specifically for diabetes , may not have been of sufficient intensity , frequency , or duration to effect positive changes in many aspects of physiology or health status relevant to older people with diabetes PURPOSE To examine the effects of a 12-week tai chi program on quality of life and exercise capacity in patients with heart failure . METHODS Thirty patients with chronic stable heart failure and left ventricular ejection fraction < or = 40 % ( mean [ + /- SD ] age , 64 + /- 13 years ; mean baseline ejection fraction , 23 % + /- 7 % ; median New York Heart Association class , 2 [ range , 1 to 4 ] ) were r and omly assigned to receive usual care ( n = 15 ) , which included pharmacologic therapy and dietary and exercise counseling , or 12 weeks of tai chi training ( n = 15 ) in addition to usual care . Tai chi training consisted of a 1-hour class held twice weekly . Primary outcomes included quality of life and exercise capacity . Secondary outcomes included serum B-type natriuretic peptide and plasma catecholamine levels . For 3 control patients with missing data items at 12 weeks , previous values were carried forward . RESULTS At 12 weeks , patients in the tai chi group showed improved quality -of-life scores ( mean between-group difference in change , -25 points , P = 0.001 ) , increased distance walked in 6 minutes ( 135 meters , P = 0.001 ) , and decreased serum B-type natriuretic peptide levels ( -138 pg/mL , P = 0.03 ) compared with patients in the control group . A trend towards improvement was seen in peak oxygen uptake . No differences were detected in catecholamine levels . CONCLUSION Tai chi may be a beneficial adjunctive treatment that enhances quality of life and functional capacity in patients with chronic heart failure who are already receiving st and ard medical therapy PURPOSE This study evaluated the effect of Tai Chi Chuan ( TCC ) on the autonomic nervous modulation in older persons . METHODS Twenty TCC practitioners and 20 normal controls were included in this study . The stationary state spectral heart rate variability ( HRV ) measures between TCC practitioners and normal controls , and the sequential changes in HRV measures after classical Yang 's TCC were compared . RESULTS The total power , very low-frequency power , low-frequency power , normalized low-frequency power , and low-/high-frequency power ratios in TCC practitioners were all significantly higher than those of normal controls , whereas the heart rate and systolic and diastolic blood pressures were not different between these two groups of subjects . After TCC , the normalized high-frequency power increased significantly from 22.8 + /- 14.6 normalized units ( nu ) before TCC to 28.2 + /- 16.1 nu 30 min after TCC and to 30.6 + /- 18.4 nu 60 min after TCC . In contrast , the low-/high-frequency power ratio decreased significantly from 2.5 + /- 2.4 before TCC to 1.8 + /- 1.4 30 min after TCC and to 2.2 + /- 2.9 60 min after TCC . The heart rate , systolic blood pressure , diastolic blood pressure , mean arterial blood pressure , and pulse pressure also decreased sequentially after TCC . CONCLUSION The short-term effect of TCC was to enhance the vagal modulation and tilt the sympathovagal balance toward deceased sympathetic modulation in older persons . TCC might be good health-promoting calisthenics for older persons OBJECTIVE To estimate the incremental effects on cost and quality of life of cardiac rehabilitation after an acute coronary syndrome . DESIGN Open r and omised controlled trial with 1 year 's follow-up . Analysis was on an intention-to-treat basis . SETTING Two tertiary hospitals in Sydney . INTERVENTION 18 sessions of comprehensive exercise-based outpatient cardiac rehabilitation or conventional care as provided by the treating doctor . PARTICIPANTS 113 patients aged 41 - 75 years who were self-caring and literate in English . Patients with uncompensated heart failure , uncontrolled arrhythmias , severe and symptomatic aortic stenosis or physical impairment were excluded . MAIN OUTCOME MEASURES Costs ( hospitalisations , medication use , outpatient visits , investigations , and personal expenses ) ; and measures of quality of life . Incremental cost per quality -adjusted life year ( QALY ) saved at 1 year ( this estimate combines within- study utility effects with reported 1-year risk of survival and treatment effects of rehabilitation on mortality ) . Sensitivity analyses around a base case estimate included alternative assumptions of no treatment effect on survival , 3 years of treatment effect on survival and variations in utility . RESULTS The estimated incremental cost per QALY saved for rehabilitation relative to st and ard care was 42,535 US dollars when modelling included the reported treatment effect on survival . This increased to 70,580 US dollars per QALY saved if treatment effect on survival was not included . The results were sensitive to variations in utility and ranged from 19,685 US dollars per QALY saved to rehabilitation not being cost-effective . CONCLUSIONS The effects on quality of life tend to reinforce treatment advantages on survival for patients having postdischarge rehabilitation after an acute coronary syndrome . The estimated base case incremental cost per QALY saved is consistent with those historically accepted by decision making authorities such as the Pharmaceutical Benefits Advisory Committee In this study , 126 patients ( 90 males , average age 56 years , range 39 - 80 ) were r and omised to Wu Chian-Ch'uan style Tai Chi ( 38 ) , aerobic exercise ( 41 ) or a non-exercise support group ( 47 ) following acute myocardial infa rct ion . Patients attended twice weekly for three weeks then weekly for a further five weeks . Heart rate and blood pressure were recorded before and after each session . Over the 11 sessions of exercise there was a negative trend in diastolic blood pressure only in the Tai Chi group ( Rs = 0.79 , p < 0.01 ) . Significant trends in systolic blood pressure occurred in both exercise groups ( Rs = 0.64 and 0.63 , both p < 0.05 ) . Only four ( 8 % ) patients completed the support group eight-week programme which was less than the number completing Tai Chi ( 82 % ; p < 0.001 ) and aerobic exercise groups ( 73 % ; p < 0.001 ) BACKGROUND / AI
Output:
| Preliminary evidence suggests that Tai Chi Chuan can be an unconventional form of cardiac rehabilitation , being an adjunctive therapy in the treatment of patients with stable coronary artery disease . |
MS213525 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A cross-sectional study to assess home glucose monitoring practice s was conducted in 200 non-insulin-treated diabetic patients consecutively attending our hospital clinic . Of the 200 , 97 ( 48 % ) patients ( Group 1 ) regularly monitored urine ( n = 74 ) , blood ( n = 19 ) or both ( n = 4 ) ; 103 ( 52 % ) patients ( Group 2 ) performed no home monitoring . The two groups were similar in terms of age , sex , duration of diabetes and type of treatment . The prevalence of diabetic complications was also closely comparable and only peripheral neuropathy differed between the groups , being more common in Group 1 ( n = 12 ) than Group 2 ( n = 4 ) ; p < 0.05 . There was also no significant difference between the HbA1 concentration ( mean + /- SD ) in Group 1 ( 9.7 + /- 2.2 % ) and Group 2 ( 9.4 + /- 2.0 % ) . The mean frequency of home monitoring was four tests weekly , but only 21 ( 22 % ) kept a written record and 60 ( 62 % ) would never alter their treatment on the basis of their results . Almost a third of patients could not interpret the results of monitoring or give the normal range of values . Home glucose monitoring , particularly of urine , is widely practised in Type 2 diabetes , at considerable overall expense . However , convincing evidence of its value in helping patients improve their blood glucose control or preventing the complications of the disease is lacking OBJECTIVE To investigate the effect of meal-related self-monitoring of blood glucose on glycemic control and well-being in non-insulin-treated type 2 diabetic patients . RESEARCH DESIGN AND METHODS This 6-month study , which included 6 months of follow-up , adopted a prospect i ve , multicenter , r and omized controlled design . Subjects were r and omized to two groups : one group used a blood glucose-monitoring device , kept a blood glucose/eating diary , and received st and ardized counseling ; the control group received nonst and ardized counseling on diet and lifestyle . The primary efficacy parameter was the change in HbA(1c ) . Secondary efficacy variables included changes in body weight , lipids , and microalbumin and changes in treatment satisfaction and well-being . RESULTS In the per- protocol analysis , the use of a self-monitoring blood glucose device significantly reduced HbA(1c ) levels by 1.0 + /- 1.08 % compared with 0.54 + /- 1.41 % for the control group ( P = 0.0086 ) ; subgroup analysis showed three types of responders . Body weight , total cholesterol , and microalbumin improved when using a glucometer , but there was no statistically significant difference between the two groups . Treatment satisfaction increased in both groups to a similar extent ( P = 0.9 ) . Self-monitoring result ed in a marked improvement of general well-being with significant improvements in the subitems depression ( P = 0.032 ) and lack of well-being ( P = 0.02 ) . CONCLUSIONS Meal-related self-monitoring of blood glucose within a structured counseling program improved glycemic control in the majority of non-insulin-treated type 2 diabetic patients in this study . The finding of three types of responders will be important for future planning of counseling and educational interventions Some features of diabetes care and diabetes treatment regimen which may have an impact on health-related quality of life ( HRQOL ) in people with diabetes were studied cross-sectionally using the SF-20 question naire . Of the 381 subjects with Type 2 diabetes aged under 65 years , 260 ( 68 % ) participated in the study . On univariate analysis , HRQOL was associated with regular clinical review ( check-up at least twice a year ) and continuity of care ( the same GP for at least 2 years ) , education by a diabetes nurse , and satisfaction with diabetes education . No associations were found between the HRQOL dimensions and home glucose monitoring , participation in educational courses , or satisfaction with care . On logistic regression analysis only good continuity of care was significantly associated with the better well-being dimensions of the SF 20 ( ORs 2.5 - 6.0 ) . However , good continuity of care was also associated with less satisfactory glucose control ( HbA(1c ) 8.9 + /- 2.0 ( + /- SD ) vs 8.3 + /- 2.0 % , P=0.04 ) . It is concluded that a permanent physician-patient relationship may improve HRQOL in subjects with Type 2 diabetes , but further prospect i ve studies are needed to confirm this finding Objective To determine whether self monitoring , alone or with instruction in incorporating the results into self care , is more effective than usual care in improving glycaemic control in non-insulin treated patients with type 2 diabetes . Design Three arm , open , parallel group r and omised trial . Setting 48 general practice s in Oxfordshire and South Yorkshire . Participants 453 patients with non-insulin treated type 2 diabetes ( mean age 65.7 years ) for a median duration of three years and a mean haemoglobin A1c level of 7.5 % . Interventions St and ardised usual care with measurements of HbA1c every three months as the control group ( n=152 ) , blood glucose self monitoring with advice for patients to contact their doctor for interpretation of results , in addition to usual care ( n=150 ) , and blood glucose self monitoring with additional training of patients in interpretation and application of the results to enhance motivation and maintain adherence to a healthy lifestyle ( n=151 ) . Main outcome measure HbA1c level measured at 12 months . Results At 12 months the differences in HbA1c level between the three groups ( adjusted for baseline HbA1c level ) were not statistically significant ( P=0.12 ) . The difference in unadjusted mean change in HbA1c level from baseline to 12 months between the control and less intensive self monitoring groups was −0.14 % ( 95 % confidence interval −0.35 % to 0.07 % ) and between the control and more intensive self monitoring groups was −0.17 % ( −0.37 % to 0.03 % ) . Conclusions Evidence is not convincing of an effect of self monitoring blood glucose , with or without instruction in incorporating findings into self care , in improving glycaemic control compared with usual care in reasonably well controlled non-insulin treated patients with type 2 diabetes . Trial registration Current Controlled Trials IS RCT N47464659 The goal of this study was to compare the relative efficacy and cost of self-monitoring of blood glucose ( SMBG ) with routine urine testing in the management of patients with type II ( non-insulin-dependent ) diabetes mellitus not treated with insulin . Fifty-four patients with type II diabetes mellitus , not treated with insulin , who had inadequate glucose control on diet aloneor diet and oral hypoglycemic agents were studied . Patients performed SMBG or urine glucose testing as part of a st and ardized treatment program that also included diet and exercise counseling . During the 6-mo study , both the urine-testing and SMBG groups showed similar improvement in glycemic control ; within each group , there were significant improvements in fasting plasma glucose ( reduction of 1.4 ± 3.2 mM , P < 0.03 ) and glycosylated hemoglobin ( reduction of 2.0 ± 3.4 % , P < 0.01 ) levels . Seventeen ( 31 % ) of54 patients actually normalized their glycosylated hemoglobin values , 9 in the urine-testing group and 8 in the SMBG group . Comparisons between the urine-testing and SMBG groups showed no significant differences in mean fasting plasma glucose ( P > 0.86 ) , glycosylated hemoglobin ( P > 0.95 ) , or weight ( P < 0.19 ) . In patients with type II diabetes mellitus not treated with insulin , SMBG is no more effective , but is 8–12 times more expensive , thanurine testing in facilitating improved glycemic control . Our results do not support widespread use of SMBG in diabetic patients not treated with insulin Background We do not yet know how to use blood glucose self-monitoring ( BGSM ) most effectively in the self-management of type 2 diabetes treated with oral medication . Training in monitoring may be most effective in improving glycaemic control and well being when results are linked to behavioural change . Methods / design DiGEM is a three arm r and omised parallel group trial set in UK general practice s. A total of 450 patients with type 2 diabetes managed with lifestyle or oral glucose lowering medication are included . The trial compares effectiveness of three strategies for monitoring glycaemic control over 12 months ( 1 ) a control group with three monthly HbA1c measurements ; interpreted with nurse-practitioner ; ( 2 ) A self-testing of blood glucose group ; interpreted with nurse- practitioner to inform adjustment of medication in addition to 1 ; ( 3 ) A self-monitoring of blood glucose group with personal use of results to interpret results in relation to lifestyle changes in addition to 1 and 2.The trial has an 80 % power at a 5 % level of significance to detect a difference in change in the primary outcome , HbA1c of 0.5 % between groups , allowing for an attrition rate of 10 % . Secondary outcome measures include health service costs , well-being , and the intervention effect in sub-groups defined by duration of diabetes , current management , health status at baseline and co-morbidity . A mediation analysis will explore the extent to which changes in beliefs about self-management of diabetes between experimental groups leads to changes in outcomes in accordance with the Common Sense Model of illness . The study is open and has recruited more than half the target sample . The trial is expected to report in 2007 . Discussion The DiGEM intervention and trial design address weaknesses of previous research by use of a sample size with power to detect a clinical ly significant change in HbA1c , recruitment from a well-characterised primary care population , definition of feasible monitoring and behaviour change strategies based on psychological theory and evidence , and measures along the hypothesised causal path from cognitions to behaviours and disease and well being related outcomes . The trial will provide evidence to support , focus or discourage use of specific BGSM strategies A diabetes protocol characterized by self-monitoring of blood glucose was introduced in four general practice s with the aim of making the frequency of consultations dependent on the metabolic regulation and emphasizing body weight reduction . The feasibility of the programme was investigated and the results after 1 year were compared with those of conventional care in four control practice s. In the experimental practice s , 13 patients switched from a medical specialist 's to a general practitioner 's supervision , 20 remained under supervision of their GP and 33 started self-monitoring . The self-monitoring rate , the consultation frequency according to protocol , the low number of dropouts and inadequate referrals and adherence to the therapeutic scheme showed that the protocol was feasible for both the GPs and the patients . At the initial assessment , the regulation of the diabetes was worse in patients of the experimental group , compared with those of the control group ( mean HbA1 9.7 % vs 8.9 % ; p less than 0.05 ) . On average , patients in the experimental group ( n = 56 ) lost 0.4 kg of body weight , whereas those in the control group ( n = 73 ) gained 0.1 kg ( n.s . ) . The mean change in HbA1 , adjusted for the initial value , was -0.4 % in the experimental and + 0.5 % in the control group ( p less than 0.05 ) . The results of the protocol can be attributed to a combination of greater participation of the patient , the individualized consultation frequency and the prescription of oral hypoglycaemic agents according to body weight development OBJECTIVE Recent Veterans Affairs ( VA ) guidelines recommend that persons with stable type 2 diabetes controlled on oral agents or diet therapy perform self-monitoring of blood glucose ( SMBG ) twice weekly . We assessed the impact of a modification of these guidelines on hemoglobin A1c ( HbA1c ) and monitoring cost . STUDY DESIGN Retrospective , noncrossover clinical trial . PATIENTS AND METHODS We instructed persons with type 2 diabetes to perform SMBG testing according to modified adapted VA guidelines . We compared patients ' baseline average testing frequency and HbA1c with those obtained during a 6-month interval beginning 2 months after implementation of the modified guidelines . The impact on the cost of monitoring was calculated . RESULTS At baseline , 913 of 1,213 SMBG users with diabetes on oral hypoglycemic agents had HbA1c tested ( HbA1c = 7.83 % + /- 1.34 % ) ; their frequency of SMBG was 1.36 + /- 0.95 strips per patient per day . Postimplementation , 974 of 1,278 persons with diabetes had HbA1c tested ( HbA1c = 7.86 % + /- 1.54 % ; P= .63 vs baseline ) ; frequency of SMBG decreased by 46 % to 0.74 + /- 0.50 strips per patient per day ( P < .0001 ) . At baseline , 154 of 254 SMBG users with diabetes on diet therapy had
Output:
| Evidence from the cross-sectional and longitudinal studies was inconclusive .
Evidence from r and omized controlled trials suggests that SMBG may lead to improvements in glucose control .
CONCLUSIONS SMBG may be effective in controlling blood glucose for patients with type 2 diabetes .
There is a need for studies that implement all the components of the process for self-regulation of SMBG to assess whether patient use of SMBG will improve HbA1c levels |
MS213526 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIMS AND OBJECTIVES This study aim ed to examine the effects of nurse-delivered home visits combined with telephone intervention on medication adherence , and quality of life in HIV-infected heroin users . BACKGROUND Drug use is consistently reported as a risk factor for medication non-adherence in HIV-infected people . DESIGN An experimental , pretests and post-tests , design was used : baseline and at eight months . METHODS A sample of 116 participants was recruited from three antiretroviral treatment sites , and 98 participants completed the study . They were r and omly assigned to two groups : 58 in the experimental group and 58 in the control group . The experimental group received nurse-delivered home visits combined with telephone intervention over eight months , while the control group only received routine care . The question naire of Community Programs for Clinical Research on AIDS ( CPCRA ) Antiretroviral Medication Self-Report was used to assess levels of adherence , while quality of life and depression were evaluated using Chinese versions of World Health Organization Quality of Life Instrument-Abbreviated version ( WHOQOL-BREF ) and Self-rating Depression Scale , respectively . Data were obtained at baseline and eight months . RESULTS At the end of eight months , participants in the experimental group were more likely to report taking 100 % of pills ( Fisher 's exact = 14.3 , p = 0.0001 ) and taking pills on time ( Fisher 's exact = 18.64 , p = 0.0001 ) than those in the control group . There were significant effects of intervention in physical ( F = 10.47 , p = 0.002 ) , psychological ( F = 9.41 , p = 0.003 ) , social ( F = 4.09 , p = 0.046 ) and environmental ( F = 4.80 , p = 0.031 ) domains of WHOQOL and depression ( F = 5.58 , p = 0.02 ) . CONCLUSIONS Home visits and telephone calls are effective in promoting adherence to antiretroviral treatment and in improving the participants ' quality of life and depressive symptoms in HIV-infected heroin users . RELEVANCE TO CLINICAL PRACTICE It is important for nurses to recognise the issues of non-adherence to antiretroviral treatment in heroin users . Besides st and ard care , nurses should consider conducting home visits and telephone calls to ensure better health outcome of antiretroviral treatment in this population Abstract A r and om sample of 271 people living with HIV ( PLWH ) who were former plasma/blood donors and a convenience sample of 67 HIV negative villagers were anonymously interviewed . Compared with the non-PLWH , PLWH reported higher prevalence of symptoms of depression ( adjusted OR = 2.53 , p=0.001 ) , anxiety ( adjusted OR = 1.85 , p=0.04 ) , and stress ( adjusted OR = 1.77 , p=0.06 ) . Of the PLWH respondents , 81.7 % received Highly Active Antiretroviral Therapy ( HAART ) ; 32.1 % of whom reported some side effects . Respectively 13.7 % , 37.4 % , and 38.4 % PLWH perceived discrimination from their family members , relatives/friends , and neighbors . Absence of HAART , poor physical function , perceived discrimination from relatives and friends , and low level of resilience were associated with depression ( stepwise regression ; β = − 0.28–0.17 , R-square = 0.22 ) , anxiety and stress ( R-square = 0.32 and 0.16 , respectively ) . The majority of respondents ( 70.1 % ) desired group intervention as a means for providing psychological support services . Relevant programs should both remove risk factors ( e.g. , absence of medical treatment , HIV-related discrimination ) and promote protective factors ( e.g. , resilience ) . Support group is one of the potentially useful approaches to provide psychological support services Two-thirds of those with HIV worldwide live in sub-Saharan Africa . Alcohol use is associated with the HIV epidemic through risky sex and suboptimal ARV adherence . In western Kenya , hazardous drinking was reported by HIV ( 53 % ) and general medicine ( 68 % ) out patients . Cognitive behavioral treatment ( CBT ) has demonstrated strong efficacy to reduce alcohol use . This article reports on a systematic cultural adaptation and pilot feasibility study of group paraprofessional-delivered CBT to reduce alcohol use among HIV-infected out patients in Eldoret , Kenya . Following adaptation and counselor training , five pilot groups were run ( n = 27 ) . Overall attendance was 77 % . Percent days abstinent from alcohol ( PDA ) before session 1 was 52–100 % ( women ) and 21–36 % ( men ) , and by session 6 was 96–100 % ( women ) and 89–100 % ( men ) . PDA effect sizes ( Cohen ’s d ) between first and last CBT session were 2.32 ( women ) and 2.64 ( men ) . Participants reported treatment satisfaction . Results indicate feasibility , acceptability and preliminary efficacy for CBT in Kenya BACKGROUND Psychiatric disorders in HIV/AIDS are common , emerging soon after diagnosis or during the subsequent course of illness . However , there are few prospect i ve studies on the rates of psychiatric disorders in HIV/AIDS , particularly in the context of the developing world . METHODS Sixty-five patients with recently diagnosed HIV were interviewed on presentation to a hospital-based HIV clinic and then 6 months later . On both interviews , the patients were assessed using the MINI International Neuropsychiatric Interview , the Carver Brief COPE , and the Sheehan Disability Scale . Exposure to negative life events and risk behaviors was also evaluated . RESULTS The overall prevalence of psychiatric disorders in the follow-up period remained high ( 56 % of patients had at least one psychiatric disorder at baseline , and 48 % of patients had at least one psychiatric disorder at 6 months ) . Depression and posttraumatic stress disorder ( PTSD ) were the most prevalent disorders at both baseline ( 34.9 % and 14.8 % ) and follow-up ( 26 % and 20 % ) , respectively . More than half of all patients with depression at baseline improved ( 16 of 29 ; 55.1 % ) . However , there was a new onset of both depression ( 4 of 49 ; 8.1 % ) and PTSD ( 12 of 17 ; 70.5 % ) on follow-up . In univariate analysis , depression on follow-up was significantly associated with : ( a ) disability in work/social/family functioning , ( b ) greater number of negative life events , and ( c ) a decline in CD4 lymphocyte count . Univariate analysis also revealed that a diagnosis of PTSD on follow-up was significantly associated with ( a ) a longer duration of infection and ( b ) baseline disability in work/social/family functioning . However , in multivariate analysis , only disability scores predicted the diagnoses of major depression and PTSD on follow-up assessment . Persistence of risky sexual behaviour was also noted , with a significantly higher number of participants reporting nonuse of condom on follow-up . There appeared to be a shift from maladaptive coping behaviors to more adaptive coping behaviors over the 6-month period . CONCLUSION The rate of psychiatric disorders in HIV/AIDS patients was consistent over time . These findings emphasize the importance of regular evaluation for psychiatric disorders in HIV/AIDS patients , not only at the commencement of treatment but also during subsequent follow-up visits Background The devastating impact of AIDS in the world especially in sub-Saharan Africa has led to an unprecedented global effort to ensure access to antiretroviral ( ARV ) drugs . Given that medication-taking behavior can immensely affect an individual 's response ; ART adherence is now widely recognized as an ' Achilles heel ' for the successful outcome . The present study was undertaken to investigate the rate and predictors of adherence to antiretroviral therapy among HIV-infected persons in southwest Ethiopia . Methods The study was conducted in the antiretroviral therapy unit of Jimma University Specialized Hospital . A prospect i ve study was undertaken on a total of 400 HIV infected person . Data were collected using a pre-tested interviewer-administered structured question naire at first month ( M0 ) and third month ( M3 ) follow up visits . Results A total of 400 and 383 patients at baseline ( M0 ) and at follow up visit ( M3 ) respectively were interviewed . Self-reported dose adherence in the study area was 94.3 % . The rate considering the combined indicator ( dose , time and food ) was 75.7 % . Within a three month follow up period , dose adherence decreased by 2 % and overall adherence rate decreased by more than 3 % . Adherence was common in those patients who have a social support ( OR , 1.82 , 95%CI , 1.04 , 3.21 ) . Patients who were not depressed were two times more likely to be adherent than those who were depressed ( OR , 2.13 , 95%CI , 1.18 , 3.81 ) . However , at the follow up visit , social support ( OR , 2.42 , 95%CI , 1.29 , 4.55 ) and the use of memory aids ( OR , 3.29 , 95%CI , 1.44 , 7.51 ) were found to be independent predictors of adherence . The principal reasons reported for skipping doses in this study were simply forgetting , feeling sick or ill , being busy and running out of medication in more than 75 % of the cases . Conclusion The self reported adherence rate was high in the study area . The study showed that adherence is a dynamic process which changes overtime and can not reliably be predicted by a few patient characteristics that are assumed to vary with time . Adherence is a process , not a single event , and adherence support should be integrated into regular clinical follow up Objective : To examine the effect of a 15-session individually delivered cognitive behavioral intervention on antiretroviral ( ART ) medication adherence . Design : A multisite , 2-group , r and omized controlled trial . Participants : Two hundred four HIV-infected participants with self-reported ART adherence < 85 % from a total of 3818 participants screened were r and omized into the trial . Potential participants were recruited for the main trial based on sexual risk criteria in Los Angeles , Milwaukee , New York , and San Francisco . Intervention : The primary outcome of the intervention was a reduction in HIV transmission risk behaviors . Fifteen 90-minute individually delivered sessions were divided into 3 modules : Stress , Coping , and Adjustment ; Safer Behaviors ; and Health Behaviors , including an emphasis on ART adherence . Controls received no intervention until trial completion . Both groups completed follow-up assessment s at 5 , 10 , 15 , 20 , and 25 months after r and omization . Main Outcome Measure : Self-reported ART adherence as measured by 3-day computerized assessment . Results : A significance difference in rates of reported adherence was observed between intervention and control participants at months 5 and 15 , corresponding to the assessment s after the Stress , Coping , and Adjustment module ( 5-month time point ) and after the Health Behaviors module ( 15-month time point ) . The relative improvements among the intervention group compared with the control group dissipated at follow-up . Conclusions : Cognitive behavioral intervention programs may effectively improve ART adherence , but the effects of intervention may be short-lived The effects of alcohol abuse on HIV disease progression have not been definitively established . A prospect i ve , 30-month , longitudinal study of 231 HIV(+ ) adults included history of alcohol and illicit drug use , adherence to antiretroviral therapy ( ART ) , CD4(+ ) cell count , and HIV viral load every 6 months . Frequent alcohol users ( two or more drinks daily ) were 2.91 times ( 95 % CI : 1.23 - 6.85 , p = 0.015 ) more likely to present a decline of CD4 to < or=200 cells/microl , independent of baseline CD4(+ ) cell count and HIV viral load , antiretroviral use over time , time since HIV diagnosis , age , and gender . Frequent alcohol users who were not on ART also increased their risk for CD4 cell decline to < or=200 cells/mm(3 ) ( HR = 7.76 : 95 % CI : 1.2 - 49.2 , p = 0.03 ) . Combined frequent alcohol use with crack-cocaine showed a significant risk of CD4(+ ) cell decline ( HR = 3.57 : 95 % CI : 1.24 - 10.31 , p = 0.018 ) . Frequent alcohol intake was associated with higher viral load over time ( beta = 0.259 , p = 0.038 ) . This significance was maintained in those receiving ART ( beta = 0.384 , p = 0.0457 ) , but not in those without ART . Frequent alcohol intake and the combination of frequent alcohol and crack-cocaine accelerate HIV disease progression . The effect of alcohol on CD4(+ ) cell decline appears to be independent of
Output:
| RESULTS This review found ample and moderately consistent evidence that adverse mental health and alcohol consumption are associated with reduced adherence .
This review suggests that psychosocial factors , namely , depression and alcohol may have adverse effects upon HIV-related outcomes . |
MS213527 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIMS Whilst the CArdiac REsynchronization in Heart Failure ( CARE-HF ) trial has shown that cardiac resynchronization therapy ( CRT ) leads to reduced morbidity and mortality , the cost-effectiveness of this therapy remains uncertain . The aim of this study was to evaluate the incremental cost per quality adjusted life year ( QALY ) gained and incremental cost per life year gained of CRT plus medical therapy compared to medical therapy alone . METHODS AND RESULTS This prospect i ve analysis based on intention to treat data from all patients enrolled in the CARE-HF trial at 82 clinical centres in 12 European countries . A total of 813 patients with New York Heart Association class III or IV heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony were r and omized to CRT plus medical therapy ( n = 409 ) vs. medical therapy alone ( n = 404 ) . During a mean follow-up of 29.4 months CRT was associated with increased costs ( 4316 , 95 % CI : 1327 - 7485 ) , survival ( 0.10 years , 95 % CI : -0.01 - 0.21 ) , and QALYs ( 0.22 , 95 % CI : 0.13 - 0.32 ) . The incremental cost-effectiveness ratio was 19 319 per QALY gained ( 95 % CI : 5482 - 45 402 ) and 43 596 per life-year gained ( 95 % CI : -146 236 - 223 849 ) . These results were sensitive to the costs of the device , procedure , and hospitalization . CONCLUSION Treatment with CRT appears cost-effective at the notional willingness to pay threshold of 29 400 ( 20,000 pounds sterlings ) per QALY gained OBJECTIVES The evaluation of the risk of recurring heart failure events ( HFEs ) was a pre-specified sub study of MADIT-CRT ( Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy ) . BACKGROUND There are limited data regarding the effect of cardiac resynchronization therapy with a defibrillator ( CRT-D ) on the occurrence of recurring heart failure episodes after a first post-implantation HFE . METHODS Data with regard to recurring HFEs were prospect ively collected for all 1,820 MADIT-CRT participants . The CRT-D versus defibrillator-only risk for nonfatal first- and subsequent-HFEs was assessed by Cox proportional hazards and And ersen-Gill proportional intensity regression modeling , respectively , in efficacy analyses recognizing active device-type during follow-up . RESULTS Multivariate analysis showed that CRT-D was associated with a significant reduction in the risk of a first HFE ( hazard ratio [ HR ] : 0.54 , 95 % confidence interval [ CI ] : 0.44 to 0.67 , p < 0.001 ) and with a similar magnitude of reduction in the risk of HFEs subsequent to a first post-enrollment event ( HR : 0.62 , 95 % CI : 0.45 to 0.85 , p = 0.003 ) . The benefit of CRT-D for the prevention of first and subsequent HFEs was pronounced among patients with left bundle branch block ( HR : 0.38 , 95 % CI : 0.29 to 0.49 , p < 0.001 ; and HR : 0.50 , 95 % CI : 0.33 to 0.76 , p = 0.001 , respectively ) and nonsignificant in non-left bundle branch block patients ( HR : 1.12 , 95 % CI : 0.77 to 1.64 , p = 0.55 ; and HR : 0.99 , 95 % CI : 0.58 to 1.69 , p = 0.96 , respectively ; p values for interaction : p < 0.001 and p = 0.06 , respectively ) . The occurrences of first and second HFEs were associated with 7- and nearly 19-fold respective increases in the risk of subsequent mortality . CONCLUSIONS In the MADIT-CRT trial , the benefit of cardiac resynchronization therapy for the reduction in recurring HFEs was maintained after the occurrence of a first post-enrollment event . The occurrence of HFEs greatly increased the risk of death . ( Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy ; NCT00180271 ) BACKGROUND We conducted a prospect i ve , multicenter , r and omized comparison of implantable cardioverter-defibrillator ( ICD ) versus antiarrhythmic drug therapy in survivors of cardiac arrest secondary to documented ventricular arrhythmias . METHODS AND RESULTS From 1987 , eligible patients were r and omized to an ICD , amiodarone , propafenone , or metoprolol ( ICD versus antiarrhythmic agents r and omization ratio 1:3 ) . Assignment to propafenone was discontinued in March 1992 , after an interim analysis conducted in 58 patients showed a 61 % higher all-cause mortality rate than in 61 ICD patients during a follow-up of 11.3 months . The study continued to recruit 288 patients in the remaining 3 study groups ; of these , 99 were assigned to ICDs , 92 to amiodarone , and 97 to metoprolol . The primary end point was all-cause mortality . The study was terminated in March 1998 , when all patients had concluded a minimum 2-year follow-up . Over a mean follow-up of 57+/-34 months , the crude death rates were 36.4 % ( 95 % CI 26.9 % to 46.6 % ) in the ICD and 44.4 % ( 95 % CI 37.2 % to 51.8 % ) in the amiodarone/metoprolol arm . Overall survival was higher , though not significantly , in patients assigned to ICD than in those assigned to drug therapy ( 1-sided P=0.081 , hazard ratio 0.766 , [ 97.5 % CI upper bound 1.112 ] ) . In ICD patients , the percent reductions in all-cause mortality were 41.9 % , 39.3 % , 28 . 4 % , 27.7 % , 22.8 % , 11.4 % , 9.1 % , 10.6 % , and 24.7 % at years 1 to 9 of follow-up . CONCLUSIONS During long-term follow-up of cardiac arrest survivors , therapy with an ICD is associated with a 23 % ( nonsignificant ) reduction of all-cause mortality rates when compared with treatment with amiodarone/metoprolol . The benefit of ICD therapy is more evident during the first 5 years after the index event Background —Implantable cardioverter defibrillator ( ICD ) use reduces mortality in patients with serious ventricular arrhythmias compared with antiarrhythmic drug ( AAD ) use . However , the relative impact of these therapies on self-perceived quality of life ( QoL ) is unknown . Methods and Results —Three self-administered instruments were used to measure generic and disease-specific QoL in Antiarrhythmics Versus Implantable Defibrillators trial participants . Generalized linear models were used to assess the relationships between self-perceived QoL and treatment ( AAD versus ICD ) and adverse symptoms and ICD shocks . To minimize the impact of missing data , only patients surviving 1 year were included in the primary analyses . Baseline characteristics among QoL participants ( n=905 ) and non participants ( n=111 ) were similar , but participants who survived 1 year ( n=800 ) were healthier at baseline than nonsurvivors ( n=105 ) . Of the 800 patients in the primary analysis , characteristics of those r and omized to AAD ( n=384 ) versus ICD ( n=416 ) were similar . Overall , ICD and AAD use were associated with similar alterations in QoL. The development of sporadic shocks and adverse symptoms were each associated with reduced physical functioning and mental well-being and increased concerns among ICD recipients , whereas development of adverse symptoms was associated with reduced physical functioning and increased concerns among AAD recipients . Conclusions —ICD and AAD therapy are associated with similar alterations in self-perceived QoL over 1-year follow-up . Adverse symptoms were associated with reduced self-perceived QoL in both groups , and sporadic shocks were associated with reduced QoL in ICD recipients BACKGROUND To date , the implantable cardioverter-defibrillator ( ICD ) has been shown to be effective for primary prevention of sudden cardiac death only in selected groups of patients in the chronic phase after myocardial infa rct ion . METHODS AND RESULTS The Immediate Risk-Stratification Improves Survival ( IRIS ) Study compares ICD therapy with no ICD therapy in selected high risk patients early after myocardial infa rct ion . Special emphasis is placed on optimal acute and long term medical therapy in all patients including metoprolol CR/ZOK . The hypothesis is tested that use of the ICD reduces overall mortality . For that purpose , consecutive acute ST elevation or non-ST elevation myocardial infa rct ion patients are collected in a registry . From this denominator , patients are screened , and enrolled early after myocardial infa rct ion ( day 5 to day 31 ) if they exhibit both a reduced left ventricular ejection fraction < or = 40 % and a heart rate > or = 100 bpm on the first available electrocardiogram ( criterion I ) , or non-sustained ventricular tachycardia at a rate > or = 150 bpm during Holter ( criterion II ) . CONCLUSIONS IRIS is a large scale prospect i ve , r and omized trial to evaluate the benefit of ICD therapy for reduction of total mortality in patients considered at high risk of sudden death early after acute myocardial infa rct ion BACKGROUND Although pharmacological therapy has ameliorated symptoms and improved the survival of patients with chronic heart failure ( CHF ) , this chronic syndrome remains a progressive disease causing incremental morbidity and early mortality . A new therapy for the treatment of CHF should ideally decrease mortality , alleviate symptoms , and improve functional capacity . A growing body of evidence suggests that the use of implantable devices to resynchronize ventricular contraction may be a beneficial adjunct in the treatment of CHF . METHODS The Comparison of Medical Therapy , Pacing , and Defibrillation in Chronic Heart Failure ( COMPANION ) trial is a r and omized , open-label , 3-arm study of patients in New York Heart Association class III or IV with an ejection fraction of 35 % or less and a QRS duration of 120 milliseconds or less . The COMPANION study objectives are to determine whether optimal pharmacological therapy used with ( 1 ) ventricular resynchronization therapy alone or ( 2 ) ventricular resynchronization therapy combined with cardioverter-defibrillator capability is superior to optimal pharmacological therapy alone in reducing combined all-cause mortality and hospitalizations ; reducing cardiac morbidity ; improving functional capacity , cardiac performance , and quality of life ; and increasing total survival OBJECTIVES This study analyzed the causes of death in the Antiarrhythmics Versus Implantable Defibrillators ( AVID ) Trial . BACKGROUND Both implantable cardioverter-defibrillators ( ICDs ) and antiarrhythmic drugs ( AADs ) are used as mainstays of treatment for life-threatening ventricular arrhythmias in patients who have survived either ventricular fibrillation or sustained ventricular tachycardia with hemodynamic compromise and serious symptoms . The AVID Trial compared the effectiveness of these two therapies . Survival was better with the ICD . Assessment of the cause of death should help to determine the mechanism of improvement in survival with the ICD . METHODS Of 1,016 patients enrolled in the AVID Trial , 202 patients died . The mode of death was determined by the unblinded Principal Investigator and independently by an Events Committee , which review ed material s meticulously blinded with respect to treatment . Deaths were classified as cardiac or noncardiac . Cardiac deaths were further classified as arrhythmic or nonarrhythmic , and causes of noncardiac death were identified . RESULTS Deaths were more frequent in patients treated with an AAD ( n = 122 ) , compared with patients treated with the ICD ( n = 80 ) , unadjusted p < 0.001 , p = 0.012 adjusted for sequential monitoring . In AVID , 157 deaths were cardiac , and 79 were arrhythmic . The major effect of the ICD was to prevent arrhythmic death ( AAD = 55 , ICD = 24 , nominal unadjusted p < 0.001 ) . Nonarrhythmic cardiac deaths were equal ( AAD = 39 , ICD = 39 ) . Patients treated with an AAD had a slightly greater incidence of noncardiac deaths ( 28 vs. 17 , p = 0.053 ) , primarily due to pulmonary and renal causes . CONCLUSIONS The ICD is more effective than an AAD in reducing arrhythmic cardiac death , while nonarrhythmic cardiac death is unchanged . Of note , apparent arrhythmic death still seems to constitute 38 % of all cardiac deaths despite
Output:
| A reduction in SCD but not all-cause mortality was found in people with recent MI .
CRT-P and CRT-D reduced mortality and HF hospitalisations , and improved other outcomes , in people with HF as a result of LVSD and cardiac dyssynchrony when compared with OPT .
The rate of SCD was lower with CRT-D than with CRT-P but other outcomes were similar .
In people with both conditions , CRT-D reduced the risk of all-cause mortality and HF hospitalisation , and improved other outcomes , compared with ICDs . |
MS213528 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE A multicenter , phase II study of single-agent , intravenous methotrexate in newly diagnosed non-AIDS-related primary CNS lymphoma was conducted in the New Approaches to Brain Tumor Therapy ( NABTT ) CNS Consortium . METHODS Methotrexate ( 8 g/m(2 ) ) was initially administered every 2 weeks . The primary end point was radiographic CR or PR , as defined by st and ard radiographic criteria , and secondary end points were survival and drug-related toxicity . RESULTS Twenty-five patients were enrolled with a mean age of 60 years and median Karnofsky Performance Score of 80 . Three of 14 patients who underwent lumbar puncture had malignant cells on CSF cytopathology , and five of 25 patients had ocular involvement . Two patients could not be evaluated for the primary end point because of the absence of measurable disease in one and death before radiologic imaging in another . All patients have completed the treatment program or progressed . Among 23 patients , there were 12 CR ( 52 % ) , five PR ( 22 % ) , one ( 4 % ) with stable disease , and five progressions ( 22 % ) while on therapy . Seven patients died of tumor progression , and two died of other causes . Median progression-free survival was 12.8 months . Median overall survival for the entire group had not been reached at 22.8 + months . The toxicity of this regimen was modest , with no grade 3 or 4 toxicity in 13 of 25 patients , grade 3 toxicity in eight of 25 patients , and grade 4 toxicity in four of 25 patients after 287 cycles of chemotherapy . CONCLUSION These results indicate that high-dose methotrexate is associated with modest toxicity and a radiographic response proportion ( 74 % ) comparable to more toxic regimens PURPOSE Primary CNS lymphoma ( PCNSL ) is an aggressive primary brain tumor . Cranial irradiation alone rarely results in long-term disease control or prolonged survival . We prospect ively studied the use of combination chemotherapy plus cranial irradiation in newly diagnosed patients with PCNSL . PATIENTS AND METHODS We enrolled 102 newly diagnosed , immunocompetent patients with PCNSL ; 98 were assessable . Patients first received five cycles of methotrexate 2.5 g/m(2 ) , vincristine , procarbazine , and intraventricular methotrexate ( 12 mg ) . Whole-brain radiotherapy ( RT ) was administered to a total dose of 45 Gy and all patients received high-dose cytarabine after RT . RESULTS Fifty-eight percent of patients with measurable disease had a complete response to preirradiation chemotherapy and 36 % had a partial ( > 50 % ) response , for a 94 % response rate . Median progression-free survival was 24.0 months and overall survival was 36.9 months . Age was an important prognostic factor ; median survival was 50.4 months in patients younger than 60 and only 21.8 months in those aged 60 or older ( P < .001 ) . Fifty-three percent of patients had grade 3 or 4 toxicity during induction chemotherapy , half of which was hematologic . However , 12 patients ( 15 % ) experienced severe delayed neurologic toxicity , eight of whom died . CONCLUSION This is the first multicenter trial demonstrating improved survival with the combination of chemotherapy plus RT compared with previous reports of RT alone . A high-dose methotrexate-based regimen produced a high response rate before RT was administered . High-dose methotrexate combined with cranial irradiation is an effective therapeutic approach to PCNSL , but neurotoxicity is a delayed risk of this approach Summary Purpose : To determine whether a lower dose of hyperfractionated whole brain radiation reduces central nervous system morbidity without compromising survival for primary CNS lymphoma ( PCNSL ) patients receiving combined modality treatment . Material s and Methods : One hundred and two patients received a course of pre-radiation chemotherapy , followed by whole brain radiation , followed by cytosine-arabinoside . Initial radiation dose was 45 Gy/25 fractions ( RT ) then the study was amended to reduce this dose for complete responders to induction chemotherapy to 36 Gy/30 fractions/3 weeks ( HFX ) . Eighty-two patients received radiotherapy and were evaluable for toxicity analysis ( 66 RT patients and 16 HFX patients ) . MMSE scores and survival for the 40 patients who received radiotherapy after complete response to chemotherapy ( 27 RT and 13 HFX ) were compared . There were no notable differences in pre-treatment patient characteristics between the RT and HFX groups . Results : Neurotoxicity : By 4 years , there were 8/82 ( 10 % ) grade 5 neurotoxicities which included 2/16 ( 13 % ) grade 5 encephalopathies and 0/27 in the RT group of complete responders to chemotherapy . Survival : There was no statistically significant difference in overall or progression-free survival ( PFS ) between the chemotherapy-complete responders who received RT and HFX . Cognitive function testing : MMSE scores improved at 8 months across both treatment groups . Analysis of the area under the MMSE curve at 8 months showed no statistically significant difference between RT and HFX groups ( P=0.81 ) . Leukoencephalopathy occurred later in the HFX group than in the RT patients . Conclusion : Although the HFX schedule represented a 25 % reduction in biologically effective tumor dose in comparison , PFS and overall survival were not significantly affected . The HFX regimen delayed but did not eliminate severe neurotoxicity from chemoradiation in PCNSL patients BACKGROUND High-dose methotrexate is the st and ard of care for patients with newly diagnosed primary CNS lymphoma . The role of whole brain radiotherapy is controversial because delayed neurotoxicity limits its acceptance as a st and ard of care . We aim ed to investigate whether first-line chemotherapy based on high-dose methotrexate was non-inferior to the same chemotherapy regimen followed by whole brain radiotherapy for overall survival . METHODS Immunocompetent patients with newly diagnosed primary CNS lymphoma were enrolled from 75 centres and treated between May , 2000 , and May , 2009 . Patients were allocated by computer-generated block r and omisation to receive first-line chemotherapy based on high-dose methotrexate with or without subsequent whole brain radiotherapy , with stratification by age ( < 60 vs ≥60 years ) and institution ( Berlin vs Tübingen vs all other sites ) . The biostatistics centre assigned patients to treatment groups and informed local centres by fax ; physicians and patients were not masked to treatment group after assignment . Patients enrolled between May , 2000 , and August , 2006 , received high-dose methotrexate ( 4 g/m(2 ) ) on day 1 of six 14-day cycles ; thereafter , patients received high-dose methotrexate plus ifosfamide ( 1·5 g/m(2 ) ) on days 3 - 5 of six 14-day cycles . In those assigned to receive first-line chemotherapy followed by radiotherapy , whole brain radiotherapy was given to a total dose of 45 Gy , in 30 fractions of 1·5 Gy given daily on weekdays . Patients allocated to first-line chemotherapy without whole brain radiotherapy who had not achieved complete response were given high-dose cytarabine . The primary endpoint was overall survival , and analysis was per protocol . Our hypothesis was that the omission of whole brain radiotherapy does not compromise overall survival , with a non-inferiority margin of 0·9 . This trial is registered with Clinical Trials.gov , number NCT00153530 . FINDINGS 551 patients ( median age 63 years , IQR 55 - 69 ) were enrolled and r and omised , of whom 318 were treated per protocol . In the per- protocol population , median overall survival was 32·4 months ( 95 % CI 25·8 - 39·0 ) in patients receiving whole brain radiotherapy ( n=154 ) , and 37·1 months ( 27·5 - 46·7 ) in those not receiving whole brain radiotherapy ( n=164 ) , hazard ratio 1·06 ( 95 % CI 0·80 - 1·40 ; p=0·71 ) . Thus our primary hypothesis was not proven . Median progression-free survival was 18·3 months ( 95 % CI 11·6 - 25·0 ) in patients receiving whole brain radiotherapy , and 11·9 months ( 7·3 - 16·5 ; p=0·14 ) in those not receiving whole brain radiotherapy . Treatment-related neurotoxicity in patients with sustained complete response was more common in patients receiving whole brain radiotherapy ( 22/45 , 49 % by clinical assessment ; 35/49 , 71 % by neuroradiology ) than in those who did not ( 9/34 , 26 % ; 16/35 , 46 % ) . INTERPRETATION No significant difference in overall survival was recorded when whole brain radiotherapy was omitted from first-line chemotherapy in patients with newly diagnosed primary CNS lymphoma , but our primary hypothesis was not proven . The progression-free survival benefit afforded by whole brain radiotherapy has to be weighed against the increased risk of neurotoxicity in long-term survivors BACKGROUND We investigated the efficacy and safety of t and em high-dose methotrexate ( HD-MTX ) induction followed by high-dose busulfan/thiotepa ( HD-BuTT ) with autologous peripheral blood stem-cell transplantation ( aPBSCT ) and response-adapted whole-brain radiation therapy ( WBRT ) in patients with newly diagnosed primary central nervous system lymphoma . PATIENTS AND METHODS Twenty-three patients were treated with HD-MTX on days 1 and 10 . In case of at least a partial remission ( PR ) , HD-BuTT followed by aPBSCT was given . Patients without response to induction or without complete remission ( CR ) after HD-BuTT received WBRT . RESULTS Sixteen patients received HD-MTX and HD-BuTT achieving a CR/PR rate of 69%/13 % . CR/PR rates for all patients ( n = 23 ) were 70%/13 % . There were three deaths during therapy . With longer follow-up three neurotoxic deaths occurred in irradiated patients ( n = 9 ) , while no persistent neurotoxicity was seen after HD-BuTT without subsequent WBRT . At a median follow-up of 15 months ( range 1 - 69 ) median event-free survival ( EFS ) and overall survival ( OS ) for all patients were 17 and 20 months ( Kaplan-Meier ) , after HD-BuTT 27 months and " not reached " , respectively . Estimated 2-year EFS and OS were 45 % and 48 % for all patients versus 56 % and 61 % for the HD-BuTT group , respectively . CONCLUSION MTX induction followed by HD-BuTT is an effective and very short time-on-treatment regimen . Median survival for patients treated with high-dose chemotherapy is not reached yet . The induction regimen needs optimisation . In this study WBRT was associated with a high incidence of severe neurotoxicity 1522 Background : The role of adjuvant whole-brain irradiation ( WBI ) in PCNSL remains to be defined . Eliminating WBI from the initial treatment could reduce neurotoxicity but also adversly affect disease control and survival . METHODS Fifty-six patients were included in this prospect i ve multicenter trial to evaluate the role of adjuvant WBI in PCNSL : . All received chemotherapy ( CHX ) composed of carmustine , high-dose methotrexate ( HD-MTX ) 1.5 g/m2 , procarbazine , and dexamethasone ( only in course 1 ) . Patients without complete response ( CR ) received salvage chemotherapy with idarubicine and ifosfamide or high-dose cytarabine . Patients with CR after CHX were r and omized to either WBI or one additional CHX course . RESULTS The CR rate after CHX was 61 % ( 34/56 ) , but only 23 patients were r and omized to the two study arms . With a median follow-up of 40 months median overall survival ( OAS ) of all 24 patients without adjuvant WBI was 28.5 months ( 95 % CI 7.7 - 49.2 months ) , that of all 10 responders with adjuvant WBI 12.8 months ( 95 % CI 0 - 40.4 months ; P=0.97 ) . Responders to CHX had significantly longer survival than non-responders ( 18.2 versus 9.9 months , P=0.02 ) . Median OAS was significantly longer at institutions accruing at least 4 patients than at those with fewer patients ( 31.5 versus 9.5 months , P=0.03 ) . Late neurotoxicity developed in 5/24 ( 21 % ) patients younger than 60 years as compared to 6/32 ( 19 % ) older patients ( P=0.84 ) and in 6/28 patients after WBI as compared to 5/22 without WBI treatment ( P=0.9
Output:
| In summary , the currently available evidence ( one RCT ) is not sufficient to conclude that WBR plus chemotherapy and chemotherapy alone have similar effects on overall survival in people with PCNSL .
The findings suggest that the addition of radiotherapy ( WBR ) to chemotherapy may increase progression-free survival , but may also increase the incidence of neurotoxicity compared to chemotherapy only ( methotrexate monotherapy ) . |
MS213529 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIM The aim of this study was to review published literature concerning the use of compression treatments in the management of venous and lymphatic diseases and establish where reliable evidence exists to justify the use of medical compression and where further research is required to address areas of uncertainty . METHODS The authors search ed medical literature data bases and review ed their own collection s of papers , monographs and books for papers providing information about the effects of compression and r and omized clinical trials of compression devices . Papers were classified in accordance with the recommendations of the GRADE group to categorize their scientific reliability . Further classification was made according to the particular clinical problem that was addressed in the papers . The review included papers on compression stockings , b and ages and intermittent pneumatic compression devices . RESULTS The International Compression Club met once in Vienna and corresponded by email in order to reach an agreement of how the data should be interpreted . A wide range of compression levels was reported to be effective . Low levels of compression 10 - 30 mmHg applied by stockings are effective in the management of telangiectases after sclerotherapy , varicose veins in pregnancy , the prevention of edema and deep vein thrombosis ( DVT ) . High levels of compression produced by b and aging and strong compression stockings ( 30 - 40 mmHg ) are effective at healing leg ulcers and preventing progression of post-thrombotic syndrome as well as in the management of lymphedema . In some areas no reliable evidence was available to permit recommendations of level of compression or duration of treatment . These included : management of varicose veins to prevent progression , following surgical treatment or sclerotherapy for varicose veins , and the level of compression required to treat acute DVT . CONCLUSION This review shows that whilst good evidence for the use of compression is available in some clinical indications , there is much still to be discovered . Little is know about dosimetry in compression , for how long and at what level compression should be applied . The differing effects of elastic and short-stretch compression are also little understood The application of intermittent pneumatic compression ( IPC ) as a part of complex decongestive physiotherapy ( CDP ) remains controversial . The aim of this study was to investigate whether the combination of IPC with manual lymph drainage ( MLD ) could improve CDP treatment outcomes in women with secondary lymphedema after breast cancer treatment . A r and omized study was undertaken with 13 subjects receiving MLD ( 60 min ) and 14 receiving MLD ( 30 min ) plus IPC ( 30 min ) followed by st and ardized components of CDP including multilayered compression b and aging , physical exercise , and skin care 10 times in a 2-week-period . Efficacy of treatment was evaluated by limb volume reduction and a subjective symptom question naire at end of the treatment , and one and two months after beginning treatment . The two groups had similar demographic and clinical characteristics . Mean reductions in limb volumes for each group at the end of therapy , and at one and two months were 7.93 % and 3.06 % , 9.02 % and 2.9 % , and 9.62 % and 3.6 % , respectively ( p < 0.05 from baseline for each group and also between groups at each measurement ) . Although a significant decrease in the subjective symptom survey was found for both groups compared to baseline , no significant difference between the groups was found at any time point . The application of IPC with MLD provides a synergistic enhancement of the effect of CDP in arm volume reduction Background Prospect i ve investigations of complete decongestive lymphatic physiotherapy ( CDPT ) , including manual lymphatic drainage ( MLD ) , have vali date d the efficacy of these interventions for the initial reduction of edema and long-term maintenance of limb volume in lymphedema . However , CDPT dem and s substantial time and effort from patients to maintain these benefits ; the treatments are not always well-accepted , and patients may suffer from a deterioration in quality -of-life or a time-dependent loss of initial treatment benefits . A new device design ed for home use by the patient , the Flexitouch ™ , has been developed to mechanically simulate MLD . We have undertaken a prospect i ve , r and omized , crossover study of the efficacy of the Flexitouch ™ , when compared to massage , in the self-administered maintenance therapy of lymphedema . Methods A prospect i ve , r and omized , crossover study of maintenance therapy was performed in 10 patients with unilateral breast cancer-associated lymphedema of the arm . Each observation phase included self-administered treatment with the Flexitouch ™ or massage , 1 hour daily for 14 days , respectively , followed by crossover to the alternate treatment phase . Each treatment phase was preceded by a 1 week treatment washout , with use of garment only . The sequence of treatment was r and omly assigned . The potential impact of treatment modality on quality of life was assessed with serial administration of the SF-36 . Results Statistical analysis disclosed that the order of treatment had no outcome influence , permitting 10 comparisons within each treatment group . Post-treatment arm volume reduced significantly after the Flexitouch ™ , but not after self-administered massage . The patients ' mean weight decreased significantly with Flexitouch ™ use , but not with massage . The Flexitouch ™ device was apparently well-tolerated and accepted by patients . Serial SF-36 administration showed no deterioration in physical or psychosocial scores compared to baseline measurements ; there were no statistical differences in scores when the two treatment modalities were compared . Conclusion This short-term prospect i ve evaluation of the Flexitouch ™ suggests that the device may provide better maintenance edema control than self-adiminstered massage in breast cancer-associated lymphedema . The apparent ease of use and reliability of response to the device suggest that further broad-scale testing is warranted PURPOSE A prospect i ve evaluation was undertaken to assess the efficacy of intensive , short-term decongestive lymphatic therapy coupled with focused patient instruction in long-term self-care for the management of lymphedema . METHODS The therapeutic responses of 79 patients with lymphedema were analyzed prospect ively . Each patient received intensive , short-term decongestive lymphatic therapy , with quantification of the extent and durability of the clinical response . Decongestive lymphatic therapy was performed by therapists trained in these techniques . The mean ( + /-SD ) duration of therapy was 8+/-3 days . Instruction in self-management techniques was incorporated into the therapeutic regimen by day 3 of the patient 's treatment . The mean period of follow-up was 38+/-52 days . Changes in the volume of the affected limb were assessed with a geometric approximation derived from serial measurements of circumference along the axis of the limb . RESULTS The mean short-term reduction in limb volume was 44%+/-62 % of the excess volume in the upper extremities and 42%+/-40 % in the lower extremities . At follow-up , these results were adequately sustained : mean long-term excess volume reductions of 38%+/-56 % ( upper extremities ) and 41%+/-27 % ( lower extremities ) were observed . CONCLUSION Decongestive lymphatic therapy , combined with long-term self-management , is efficacious in treating patients with lymphedema of the extremity Sequential Intermittent Pneumatic Compression ( SIPC ) is an accepted method for treatment of peripheral lymphedema . This prospect i ve study evaluated the effect in 11 patients of a single session of SIPC on both lymphedema volume of the leg and isotope lymphography ( 99Tc dextran ) before SIPC ( control ) and 48 hours later after a 3 hour session of SIPC . Qualitative analysis of the 2 lymphoscintigrams ( LS ) was done by image interpretation by 3 physicians on a blind study protocol . The LS protocol attributed an index score based on the following variables : appearance , density and number of lymphatics , dermal backflow and collateral lymphatics in leg and thigh , visualization and intensity of popliteal and inguinal lymph nodes . Volume of the leg edema was evaluated by measuring limb circumference before and after SIPC at 6 design ated sites . Whereas there was a significant reduction of circumference in the leg after SIPC ( p<0.05 ) , there was no significant difference in the index scores of the LS before and after treatment . This acute or single session SIPC suggests that compression increased transport of lymph fluid ( i.e. , water ) without comparable transport of macromolecules ( i.e. , protein ) . Alternatively , SIPC reduced lymphedema by decreasing blood capillary filtration ( lymph formation ) rather than by accelerating lymph return thereby restoring the balance in lymph kinetics responsible for edema in the first place BACKGROUND Two phase II clinical studies used an experimental , multi-chambered compression device with different cuff pressure combinations in subjects with leg edema and chronic venous insufficiency . The objective of each study was to evaluate the safety and the relative effects of different cuff pressure combinations to determine if edema reduction was dose-dependent . METHODS Each study enrolled adults with chronic ( > or=6 weeks ) venous edema corresponding to CEAP C(3)-C(5 ) . The test device could apply different pressures at the foot , gaiter , mid-calf , and upper-calf . In the first study , the following six sustained pneumatic compression ( SPC ) profiles were applied for six hours each : 20 , 30 , and 40-mm Hg at the gaiter with graduated SPC ( ie , lower pressures at the calf ) ; and 20 , 30 , and 40-mm Hg at the gaiter with nongraduated SPC ( ie , the same pressures at the calf ) . In the second study , the following three intermittent pneumatic compression ( IPC ) profiles were applied for two hours each : 40 , 50 , and 60-mm Hg at the gaiter with graduated IPC ( ie , lower pressures at the calf ) . Each study included a baseline profile with no compression and two-day intervals between profiles . Leg volume was measured before and after compression using the water-displacement method . RESULTS A dose-response relationship was observed between increased SPC/IPC pressures and reduced limb edema . Limb volume was reduced most effectively with the highest pressures of 40-mm Hg nongraduated SPC and 60-mm Hg graduated IPC ( 136 mL and 87 mL , respectively ) ; however , some subjects reported discomfort with these profiles . Limb volume was reduced by more than 100 mL with 30 to 40-mm Hg graduated SPC and by 69 mL with 50-mm Hg graduated IPC , and subjects rated these profiles as comfortable or very comfortable . Of the 28 study participants ( 12 SPC , 16 IPC ) , two subjects reported pain with 60-mm Hg IPC ; no other adverse events were reported with SPC or IPC . CONCLUSION Pneumatic compression was safe and well-tolerated , with a dose-response relationship between increased SPC/IPC pressures and reduced leg edema . To our knowledge , this is the first study to demonstrate a dose-relationship in compression therapy : higher pressures are associated with greater volume reduction in subjects with chronic venous edema The cycle time and number of chambers in the pneumatic sleeve may influence the outcome of lymphedema therapy with intermittent compression devices . The aim of our study was to assess efficacy of several commonly used different IPC protocol s on edema volume reduction in women with postmastectomy lymphedema . Fixty-seven ( 57 ) women with secondary arm lymphedema ( age 39 - 80 ) were selected to the study . Women were r and omly assigned to two study groups with different IPC cycle times : I--90:90s and II--45:15s . Both groups were then r and omly divided into two subgroups with different sleeves : A--1 chamber sleeve ( 28 women ) and B--3 chamber sleeve ( 29 women ) . All women underwent IPC treatment for 5 weeks , 5 times a week for 1 hour ( 25 sessions ) . Arm volume measurements were performed before and after each IPC session . Significant reduction of edema volume was observed in all therapeutic subgroups , regardless of cycle times and number of chambers . In the group with short IPC cycle , better efficacy was noticed with 3-chamber sleeve . IPC is an effective method of volume reduction in women with postmastectomy arm lymphedema regardless of cycle times and number of sleeve chambers Acute ischaemia in the tibial compartments is a recognized complication of fractures , vascular injury , vascular surgery , crush injuries and burns . The tissue pressure was measured in the first week after injury and the effect of diuretics has been evaluated in a double-blind r and omized manner . The pressure in the anterior tibial compartment was measured in the first week after injury in a double-blind r and omized manner in 40 patients who had sustained either accidental or surgical injury of the leg . The pressure in the group treated with placebos increased by 20 per cent in the first 24 hours , whereas the pressure fell by 25 per cent in those treated with diuretics . Diuretic treatment is recommended for patients with injury of the lower limbs
Output:
| In select patients , IPC use may provide an acceptable home-based treatment modality in addition to wearing compression garments |
MS213530 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract . The objectives of this study were twofold : ( a ) to assess safety and tolerability of the hepatobiliary MR contrast agent MnDPDP ; and ( b ) to investigate the sensitivity of MnDPDP-enhanced MRI , in comparison with dual-phase spiral CT , in the detection of hepatocellular carcinoma ( HCC ) in cirrhosis . Fifty patients with liver cirrhosis and histologically proven HCC were enrolled in a prospect i ve phase-IIIB clinical trial . All patients underwent evaluation with dual-phase spiral CT and pre-contrast and post-contrast MRI at 1.5 T. The MR examination protocol included spin-echo ( SE ) and gradient-recalled-echo ( GRE ) T1-weighted images acquired before and 60–120 min after administration of 0.5 μmol/kg ( 0.5 ml/kg ) MnDPDP ( Teslascan , Nycomed Amersham , Oslo , Norway ) ; and fast T2-weighted SE images obtained solely before contrast injection . Gold st and ard was provided by findings at Lipiodol CT in combination with follow-up spiral CT studies , which were repeated at 4-month intervals over a 10- to 27-month ( mean ± SD 20.1 ± 5.1 months ) follow-up period . No serious adverse event occurred . Eighty tumors ranging 0.8–9.1 cm in diameter ( mean ± SD 3.2 ± 2.4 cm ) were detected by Lipiodol CT or confirmed as cancerous foci by follow-up CT studies . Pre-contrast MRI detected 38 of 80 lesions ( 48 % ) ; MnDPDP-enhanced MRI , 65 of 80 lesions ( 81 % ) ; pre-contrast plus post-contrast MRI , 69 of 80 lesions ( 86 % ) ; and dual-phase spiral CT , 64 of 80 lesions ( 80 % ) . The difference between unenhanced and MnDPDP-enhanced MRI was statistically significant ( p < 0.001 ) . The difference between MRI ( pre-contrast plus post-contrast ) and dual-phase spiral CT was not statistically significant ( p = 0.33 ) . The confidence in the final diagnosis , however , was significantly higher for MRI as compared with spiral CT ( p < 0.001 ) . MnDPDP is a safe and well-tolerated hepatobiliary MR contrast agent . Magnetic resonance imaging with use of MnDPDP is significantly more sensitive than unenhanced MRI and as good as dual-phase spiral CT for detection of HCC in cirrhosis The purpose of this study was to evaluate the value of Ferumoxide-enhanced magnetic resonance ( MR ) imaging in the detection of hepatic metastases in high-risk patients treated for colorectal cancer that have rising CEA . We used 19 patients treated previously for colorectal cancer with rising CEA levels underwent an unenhanced T(1)-weighted ( T1W ) , T(2)-weighted ( T2W ) , STIR , and Ferumoxide-enhanced hepatic MRI . Following these studies , a laparotomy was performed and the liver was evaluated by palpation and intraoperative ultrasound . Two observers who were blinded to surgical results evaluated each MR sequence separately . The number of lesions considered highly suspicious for metastatic lesions were determined for each sequence and were compared to the results of surgery . The McNemar test was used to compare the outcomes of the different sequences . MR Imaging was unable to detect small ( < 5 mm ) metastases discovered at surgery . The best non-contrast sequences for detecting metastases were the STIR with 42 % sensitivity , 83 % specificity and an overall accuracy of 56 % and the T1W sequence ( sensitivity 38 % , specificity 100 % , accuracy 57 % ) , which were not significantly different ( p 0.4 ) . The noncontrast T2W sequence had a sensitivity of 29 % and a specificity of 77 % with an overall accuracy of 46 % . When all pre contrast scans were grouped together the common sensitivity was 42 % , specificity was 77 % and accuracy was 54 % . The post-ferumoxide T(2)W scans had a sensitivity of 42 % , specificity of 85 % , and accuracy of 57 % , but did not detect any additional lesions . There was no statistical difference between the pre- and post-contrast studies with regard to identifying patients with metastatic disease ( p 0.1 ) . In conclusion , we found small hepatic metastases in patients with early signs of recurrent colorectal cancer are difficult to detect on MRI . Ferumoxide-enhanced MRI was unable to detect additional hepatic metastases and performed no better than unenhanced MRI in detecting small hepatic metastasis The purpose of this study was to compare the diagnostic accuracy of contrast-enhanced ultrasound ( CEUS ) with spiral computed tomography ( SCT ) for the characterization of focal liver lesions ( FLL ) and to determine the degree of correlation between the two techniques . Seventy-seven FLL ( 45 hepatocellular carcinomas ; 12 metastases ; ten hemangiomas ; two regenerating/dysplastic nodules ; eight focal nodular hyperplasias ) detected with ultrasound ( US ) were prospect ively evaluated by CEUS using a second-generation contrast agent and SCT ( with an interval of no more than one month between the two techniques ) . Independent observers made the most probable diagnosis and the results were compared with the final diagnoses ( histology n = 59 ; MRI n = 18 ) . Statistical analysis was performed by the Chi-square and Kappa tests . CEUS provided a correct , specific diagnosis in 69/77 ( 90 % ) of the FLL , while SCT did so in 67/77 ( 87 % ) . The sensitivity , specificity , and diagnostic accuracy for malignancy were 91 % , 90 % , and 91 % , respectively , for CEUS and 88 % , 89 % , and 88 % , respectively , for SCT . No statistically significant difference was found between CEUS and SCT in the characterization of FLL ( p > 0.05 ) . In addition , agreement between the two imaging techniques was good ( k = 0.75 ) . We conclude that CEUS and SCT provide a similar diagnostic accuracy in the characterization of FLL , with a good degree of correlation between the two techniques PURPOSE To qualitatively and quantitatively evaluate the diagnostic efficacy of the breath-hold magnetic resonance ( MR ) imaging sequences in widespread clinical use for detection and characterization of focal hepatic lesions . MATERIAL S AND METHODS Fifty patients with 143 lesions [ 57 hepatocellular carcinomas ( HCC ) , 10 borderline lesions , 18 metastatic tumors , 21 hemangiomas , and 37 cysts ] underwent single-shot fast spin echo ( SSFSE ) , fast spin echo ( FSE ) , and gadolinium-enhanced dynamic fast spoiled gradient-recalled acquisition in steady state ( FSPGR ) breath-hold MR imaging of the liver . Alternative free receiver operating characteristic ( AFROC ) analysis was performed to independently and prospect ively assess each sequence . RESULTS For solid lesions , dynamic FSPGR allowed the most sensitive lesion detection and produced the highest lesion conspicuity and lesion-liver contrast-to-noise ratio ( CNR ) . For non-solid benign lesions , SSFSE and FSE produced better results than dynamic FSPGR . SSFSE allowed the most sensitive detection and produced the best lesion conspicuity and lesion-liver CNR . CONCLUSION SSFSE and dynamic FSPGR comprise the optimal imaging protocol for breath-hold MR assessment of focal hepatic lesions . This combination of sequences allows acquisition of critical diagnostic information about both inherent T2 and T1 lesion contrast and lesion vascularity Purpose The purpose of the study was to introduce our protocol for contrast-enhanced multiphase dynamic ultrasonography ( US ) and examine the effectiveness of this method for characterizing liver tumors . Methods The subjects were 142 patients with liver tumors . The final diagnoses were 58 hepatocellular carcinomas ( HCCs ) , 4 cholangiocellular carcinomas ( CCCs ) , 14 metastases , 29 hemangiomas , 6 cases of focal nodular hyperplasia ( FNH ) , and 31 other benign lesions . The contrast agent used was Levovist . A wide-b and pulse inversion harmonic imaging mode was employed . Multiphase dynamic US was achieved by changing the sound transmission interval automatically from 0.3 s to 15.0 s according to a preset menu . Early arterial-phase images were observed at the short interval , and an equilibrium-phase image was observed at the longest interval . After a series of vascular images , a postvascular liver parenchymal image was obtained . Based on previously published criteria , the most compatible diagnosis was noted . The accuracy of this multiphase dynamic US technique for diagnosing focal liver lesions was examined by comparing our results with the final diagnosis based on a prospect i ve study . Results The overall accuracy of all 142 cases was 93.7 % . The sensitivity , specificity , and positive predictive value were , respectively , 100 % , 92.9 % , and 90.6 % for HCC ; 88.9 % , 97.6 % , and 84.2 % for metastasis or CCC ; 89.7 % , 100 % , and 100 % for hemangioma ; and 83.3 % , 100 % , and 100 % for FNH . Conclusion Contrast-enhanced multiphase dynamic US is a highly accurate , safe diagnostic tool for characterizing liver tumors Background : Hepatocellular carcinoma ( HCC ) is often detected at a relatively late stage when tumour size prohibits curative surgery . Screening to detect HCC at an early stage is performed for patients at risk . Aim : The aim of this study was to compare prospect ively the diagnostic accuracy and classification for management of the two state of the art secondline imaging techniques : triphasic spiral computer tomography ( CT ) and super paramagnetic iron oxide ( SPIO ) enhanced magnetic resonance imaging ( MRI ) . Patients : Sixty one patients were evaluated between January 1996 and January 1998 . Patients underwent CT and MRI within a mean interval of 6.75 days . Methods : CT and MRI were evaluated blindly for the presence and number of lesions , characterisation of these lesions , and classification for management . For comparison of the data on characterisation , the CT and MRI findings were compared with histopathological studies of the surgical specimens and /or follow up imaging . Data of patients not lost to follow up were available to January 2001 . Results : SPIO enhanced MRI detected more lesions and overall smaller lesions than triphasic spiral CT ( number of lesions 189 v 124 ; median diameter 1.0 v 1.8 cm ; Spearman rank 's correlation coefficient 0.63 , p<0.001 ) . There was no significant difference in accuracy between CT and MRI for lesion characterisation . The agreement in classification for management was very good ( weighted kappa 0.91 , 95 % CI 0.83–0.99 ) . Conclusion : SPIO enhanced MRI detects more and smaller lesions , but both techniques are comparable in terms of classification for management . SPIO enhanced MRI may be preferred as there is no exposure to ionising radiation Background : In recent years , liver transplantation in patients with hepatocellular cancers and cirrhosis has been restricted to those with small cancers ( < 5 cm for solitary and <3 cm for multifocal HCC with <3 nodules ) . The selection of patients for liver transplantation is based on pre-operative imaging . The accuracy of imaging correlated with explant histology and the effect of tumour stage has not been evaluated in this selected population . Methods : In this study , prospect ively collected data for 30 patients who underwent orthotopic liver transplantation for cirrhosis complicated by small hepatocellular carcinoma ( HCC ) at a single centre have been review ed with the aim of correlating radiological findings , explant histology and patient outcome . Patients who underwent orthotopic liver transplantation between 1995 and 1999 had plain and contrast-enhanced dual-phase spiral CT ( DCT ) scans of the liver . Patients suspected of having HCC on CT scan or due to elevated serum alpha-fetoprotein underwent iodized oil CT ( IOCT ) . Following transplantation , the explanted liver was serially sectioned at 10-mm intervals and examined by a pathologist blinded to the results of imaging . Data collected prospect ively on imaging and histology were compared with outcome data . The median period of follow-up was 1,139 days ( range 690–1,955 days ) after transplantation . All patients were followed up by clinical assessment , assessment of serum alpha-protein levels and imaging when indicated . Results : All the patients transplanted fulfilled the selective criteria on the basis of imaging ( solitary HCC < 5 cm in diameter or multifocal HCC <3 cm in diameter with <3 nodules ) . Of the 30 patients transplanted , 46 HCCs were detected on explant histology with a median size of 24 mm ( range 6–75 mm ) . Ten patients had multifocal disease ( median number of lesions 2 , range 2–4 ) . No significant difference was observed between IOCT and DCT with regards to the sensitivity ( 67.4 vs. 68 % ) and specificity ( 78.97 vs. 88.6 % ) of detecting HCCs . IOCT had a positive predictive value of 78.9 % as compared to 82.8 % for DCT . IOCT had an overall sensitivity of 40 % as compared to 30 % for DCT in detect
Output:
| The recommendations reported in the study are based on an extensive literature evaluation and were developed by considering the appropriateness of the choice of the imaging techniques while noninvasively detecting and characterizing focal liver lesions |
MS213531 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: In a r and omized controlled trial , we compared ab and oned children reared in institutions to ab and oned children placed in institutions but then moved to foster care . Young children living in institutions were r and omly assigned to continued institutional care or to placement in foster care , and their cognitive development was tracked through 54 months of age . The cognitive outcome of children who remained in the institution was markedly below that of never-institutionalized children and children taken out of the institution and placed into foster care . The improved cognitive outcomes we observed at 42 and 54 months were most marked for the youngest children placed in foster care . These results point to the negative sequelae of early institutionalization , suggest a possible sensitive period in cognitive development , and underscore the advantages of family placements for young ab and oned children BACKGROUND We examined the effects of a foster care intervention on attention and emotion expression in socially deprived children in Romanian institutions . METHODS Institutionalized children were r and omized to enter foster care or to remain under institutional care . Subsequently , the institutionalized and foster care groups , along with a community-based comparison group , were evaluated on emotion tasks at 30 and 42 months of age . Behaviors reflecting positive and negative affect and attention were coded from videotapes . RESULTS Data indicated that at both age points , children who received the foster care intervention showed higher levels of attention and positive affect compared to children who remained institutionalized . Compared to the community sample , children in the foster care intervention showed higher levels of attention to the emotion-eliciting tasks at 42 months of age . CONCLUSIONS The results of this r and omized trial demonstrate the impact of a family-based intervention on the development of attention and positive affect This study examined classifications of attachment in 42-month-old Romanian children ( N = 169 ) . Institutionalized since birth , children were assessed comprehensively , r and omly assigned to care as usual ( CAU ) or to foster care , and compared to family-reared children . Attachment classifications for children in foster care were markedly different from those in the CAU . Importantly , children placed in foster care before 24 months were more likely to have secure attachments and if placed earlier were less likely to have disorganized or insecure-other attachments . Cognitive status predicted greater likelihood of organized attachment in the CAU and greater likelihood of secure attachment in the foster care and never-institutionalized groups . Foster care is an important intervention to reduce the adverse effects following early deprivation BACKGROUND Children reared in institutions experience elevated rates of psychiatric disorders . Inability to form a secure attachment relationship to a primary caregiver is posited to be a central mechanism in this association . We determined whether the ameliorative effect of a foster care ( FC ) intervention on internalizing disorders in previously institutionalized children was explained by the development of secure attachment among children placed in FC . Second we evaluated the role of lack of attachment in an institutionalized sample on the etiology of internalizing disorders within the context of a r and omized trial . METHODS A sample of 136 children ( aged 6 - 30 months ) residing in institutions was recruited in Bucharest , Romania . Children were r and omized to FC ( n = 68 ) or to care as usual ( CAU ; n = 68 ) . Foster parents were recruited , trained , and overseen by the investigative team . Attachment security at 42 months was assessed using the Strange Situation Procedure , and internalizing disorders at 54 months were assessed using the Preschool Age Psychiatric Assessment . RESULTS Girls in FC had fewer internalizing disorders than girls in CAU ( OR = 0.17 , p = .006 ) . The intervention had no effect on internalizing disorders in boys ( OR = 0.47 , p = .150 ) . At 42 months , girls in FC were more likely to have secure attachment than girls in CAU ( OR = 12.5 , p < .001 ) , but no difference was observed in boys ( OR = 2.0 , p = .205 ) . Greater attachment security predicted lower rates of internalizing disorders in both sexes . Development of attachment security fully mediated intervention effects on internalizing disorders in girls . CONCLUSION Placement into FC facilitated the development of secure attachment and prevented the onset of internalizing disorders in institutionalized girls . The differential effects of FC on attachment security in boys and girls explained gender differences in the intervention effects on psychopathology . Findings provide evidence for the critical role of disrupted attachment in the etiology of internalizing disorders in children exposed to institutionalization This study investigated the effects of early institutional care on memory and executive functioning . Subjects were participants in the Bucharest Early Intervention Project ( BEIP ) and included institutionalized children , children with a history of institutionalization who were assigned to a foster care intervention , and community children in Bucharest , Romania . Memory and executive functioning were assessed at the age of 8 years using the Cambridge Neuropsychological Test and Automated Battery ( CANTAB ) . As expected , children with a history of early institutional care performed worse on measures of both visual memory and executive functioning compared to their peers without a history of institutional care . In comparing children r and omly assigned to the foster care intervention with their peers who had continued care in the institution , initial comparisons did not show significant differences on any of the memory or executive functioning outcomes . However , for one of the measures of executive functioning , after controlling for birth weight , head circumference , and duration of time spent in early institutional care , the foster care intervention was a significant predictor of scores . These results support and extend previous findings of deficits in memory and executive functioning among school-age children with a history of early deprivation due to institutional care . This study has implication s for the millions of children who continue to experience the psychosocial deprivation associated with early institutional care OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review Contrary to some conventional wisdom , in this large study that r and omly sample d orphans and separated children from 5 countries , prevalence of reported traumatic events was no worse among those institutionalized than among those in family-based care . Reported incidence of physical or sexual abuse was actually higher for those in family-based care . Underst and ing the specific context , and elements contributing to potential harm and benefits in both family-based and institutional care , are essential to promoting the best interest of the child . Contrary to some conventional wisdom , in this large study that r and omly sample d orphans and separated children from 5 countries , prevalence of reported traumatic events was no worse among those institutionalized than among those in family-based care . Reported incidence of physical or sexual abuse was actually higher for those in family-based care . Underst and ing the specific context , and elements contributing to potential harm and benefits in both family-based and institutional care , are essential to promoting the best interest of the child . Background : Policy makers struggling to protect the 153 million orphaned and separated children ( OSC ) worldwide need evidence -based research on the burden of potentially traumatic events ( PTEs ) and the relative risk of PTEs across different types of care setting s. Methods : The Positive Outcomes for Orphans study used a 2-stage , cluster-r and omized sampling design to identify 1,357 institution-dwelling and 1,480 family-dwelling orphaned and separated children in 5 low- and middle-income countries ( LMICs ) in sub-Saharan Africa and Asia . We used the Life Events Checklist developed by the National Center for Posttraumatic Stress Disorder to examine self-reported PTEs among 2,235 OSC ages 10–13 at baseline . We estimated prevalence and incidence during 36-months of follow-up and compared the risk of PTEs across care setting s. Data collection began between May 2006 and February 2008 , depending on the site . Results : Lifetime prevalence by age 13 of any PTE , excluding loss of a parent , was 91.0 % ( 95 % confidence interval ( CI ) = 85.6 , 94.5 ) in institution-dwelling OSC and 92.4 % ( 95 % CI = 90.3 , 94.0 ) in family-dwelling OSC ; annual incidence of any PTE was lower in institution-dwelling ( 23.6 % [ 95 % CI = 19.4 , 28.7 ] ) than family-dwelling OSC ( 30.0 % [ 95 % CI = 28.1 , 32.2 ] ) . More than half of children in institutions ( 50.3 % [ 95 % CI = 42.5 , 58.0 ] ) and in family-based care ( 54.0 % [ 95 % CI = 50.2 , 57.7 ] ) had experienced physical or sexual abuse by age 13 . Annual incidence of physical or sexual abuse was lower in institution-dwelling ( 12.9 % [ 95 % CI = 9.6 , 17.3 ] ) than family-dwelling OSC ( 19.4 % [ 95 % CI = 17.7 , 21.3 ] ) , indicating statistically lower risk in institution-dwelling OSC ( risk difference = 6.5 % [ 95 % CI = 1.4 , 11.7 ] ) . Conclusion : Prevalence and incidence of PTEs were high among OSC , but contrary to common assumptions , OSC living in institutions did not report more PTEs or more abuse than OSC living with families . Current efforts to reduce the number of institution-dwelling OSC may not reduce incidence of PTEs in this vulnerable population . Protection of children from PTEs should be a primary consideration , regardless of the care setting OBJECTIVES To investigate the prevalence of stereotypies in children with a history of early institutional care , evaluate the efficacy of a foster care intervention compared with institutional care on the course of stereotypies , and describe correlates in language , cognition , and anxiety for children who exhibit stereotypies . DESIGN R and omized controlled trial . SETTING Institutions in Bucharest , Romania . PARTICIPANTS One hundred thirty-six children with a history of early institutional care . Intervention Comparison of a foster care intervention with continued care as usual in an institution . MAIN OUTCOME MEASURES The presence of stereotypies as well as outcomes in language , cognition , and anxiety . RESULTS At the baseline assessment prior to placement in foster care ( average age of 22 months ) , more than 60 % of children in institutional care exhibited stereotypies . Follow-up assessment s at 30 months , 42 months , and 54 months indicated that being placed in families significantly reduced stereotypies , and with earlier and longer placements , reductions became larger . For children in the foster care group , but not in the care as usual group , stereotypies were significantly associated with lower outcomes on measures of language and cognition . CONCLUSIONS Stereotypies are prevalent in children with a history of institutional care . A foster care intervention appears to have a beneficial/moderating role on reducing stereotypies , underscoring the need for early placement in home-based care for ab and oned children . Children who continue to exhibit stereotypies after foster care placement are significantly more impaired on outcomes of language and cognition than children without stereotypies and thus may be a target for further assessment s or interventions Look After the Child Investing in children has been demonstrated to improve their lives , both during the school-age years and afterward , as assessed by outcomes such as employment and income ; furthermore , these investments often help those in the most need . Campbell et al. ( p. 1478 ) report that these investments can also lead to improved adult health . Results from a r and omized and intensive intervention that involved 122 children in four cohorts recruited in the 1970s suggest that full-day child care for the first 5 years of life has produced adults in their 30s with better metabolic and cardiovascular health measures . Large investments in preschool children ’s education , health care , and nutrition provide long-
Output:
| The major intervention pathway for ameliorating cognitive challenge seems to be placement out of the institutions which shows benefits and redresses some cognitive outcomes - yet not a total panacea .
The single study providing training and monitoring of harsh punishment and maltreatment showed immediate and decided reductions .
This data suggest , despite the paucity of studies , violence and abuse , by commission or omission is prevalent in institutions , has an effect on child well-being and is amenable to intervention .
Simple training or more complex structures to place children within conducive alternative environments ( or to avoid institutionalised placements in the first place ) seem to be the main pathway of intervention |
MS213532 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE To investigate whether sunitinib plus docetaxel improves clinical outcomes for patients with human epidermal growth factor receptor 2 (HER2)/neu-negative advanced breast cancer ( ABC ) versus docetaxel alone . PATIENTS AND METHODS In this phase III study , patients were r and omly assigned to open-label combination therapy ( sunitinib 37.5 mg/d , days 2 to 15 every 3 weeks ; and docetaxel 75 mg/m(2 ) , day 1 every 3 weeks ) or monotherapy ( docetaxel 100 mg/m(2 ) every 3 weeks ) . Progression-free survival ( PFS ) was the primary end point . RESULTS Two hundred ninety-six patients were r and omly assigned to combination therapy , and 297 patients were assigned to monotherapy . Median PFS times were 8.6 and 8.3 months with combination therapy and monotherapy , respectively ( hazard ratio , 0.92 ; one-sided P = .265 ) . The objective response rate ( ORR ) was significantly higher with the combination ( 55 % ) than with monotherapy ( 42 % ; one-sided P = .001 ) . Duration of response was similar in both arms ( 7.5 months with the combination v 7.2 months with monotherapy ) . Median overall survival ( OS ) times were 24.8 and 25.5 months with combination therapy and monotherapy , respectively ( one-sided P = .904 ) . There were 107 deaths with the combination and 91 deaths with monotherapy . The frequency of common adverse events ( AEs ) was higher with the combination , as were treatment discontinuations caused by AEs . CONCLUSION The combination of sunitinib plus docetaxel improved ORR but did not prolong either PFS or OS compared with docetaxel alone when given to an unselected HER2/neu-negative cohort as first-line treatment for ABC . Sunitinib combination therapy may also have result ed in AEs that yield an unfavorable risk-benefit ratio . The sunitinib-docetaxel regimen evaluated in this study is not recommended for further use in ABC PURPOSE This r and omized , open-label phase II study compared the efficacy of sunitinib monotherapy with that of single-agent st and ard-of-care ( SOC ) chemotherapy in patients with previously treated advanced triple-negative breast cancer ( TNBC ) . METHODS Patients with advanced TNBC , relapsed after anthracycline- and taxane-based chemotherapy , were r and omized to receive either sunitinib ( 37.5 mg/day ) or the investigator 's choice of SOC therapy . Progression-free survival was the primary endpoint . RESULTS Median progression-free survival was 2.0 months with sunitinib and 2.7 months with SOC chemotherapy ( one-sided P = 0.888 ) . Median overall survival was not prolonged with sunitinib ( 9.4 months ) compared with SOC chemotherapy ( 10.5 months ; one-sided P = 0.839 ) . The objective response rate was 3 % with sunitinib and 7 % with SOC chemotherapy ( one-sided P = 0.962 ) . CONCLUSIONS Sunitinib monotherapy did not improve efficacy compared with SOC chemotherapy in patients with previously treated advanced TNBC , for which identification of effective treatments and therapeutic targets remains an urgent need . TRIAL REGISTRATION NCT00246571 PURPOSE This phase II study evaluated the efficacy and safety of ixabepilone as neoadjuvant therapy for invasive breast cancer not amenable to breast conservation surgery . Gene expression studies were undertaken using genes that were identified as potentially associated with sensitivity/resistance to ixabepilone in prior pre clinical investigations . PATIENTS AND METHODS Patients with invasive breast cancer > or= 3 cm were eligible . Ixabepilone 40 mg/m(2 ) was administered as a 3-hour intravenous infusion on day 1 of a 21-day cycle for four or fewer cycles . RESULTS One hundred sixty-one patients were treated . The overall complete pathologic response ( pCR ) rate was 18 % in breast and 29 % in estrogen receptor ( ER ) -negative patients . Gene expression data were available for 134 patients . ER gene expression ( ER1 ) was inversely related to pCR in breast and had a positive predictive value ( PPV ) of 37 % and negative predictive value ( NPV ) of 92 % . A 10-gene penalized logistic regression ( PLR ) model developed from 200 genes predictive of ixabepilone sensitivity in pre clinical experiments included ER and tau and had higher PPV ( 45 % ) and comparable NPV ( 89 % ) to ER1 . Grade 3 to 4 adverse events ( AEs ) were reported for 32 % of patients . Except for neutropenia and leukopenia , all grade 3 to 4 AEs occurred in < or= 3 % of patients . Reversible peripheral neuropathy was experienced by 3 % of patients . CONCLUSION ER , microtubule-associated protein tau , and a 10-gene PLR model that included ER were identified as predictors of ixabepilone-induced pCR . RESULTS indicate an inverse relation between ER expression levels and ixabepilone sensitivity . Neoadjuvant ixabepilone demonstrated promising activity and a manageable safety profile in patients with invasive breast tumors Gefitinib , an epidermal growth factor receptor tyrosine kinase inhibitor , has shown both anti-proliferative and anti-tumoral activity in breast cancer . This study was design ed to determine the effect of adding gefitinib to neoadjuvant epirubicin and cyclophosphamide ( EC ) on tumor response rates . Women with unilateral , primary operable , estrogen receptor negative invasive breast cancer ≥ 2 cm were eligible for inclusion . R and omized patients were to receive four cycles of neoadjuvant EC plus 12 weeks of either gefitinib ( 250 mg daily ) or placebo . Primary endpoint was pathologic complete response ( pCR ) , and secondary endpoints were complete response ( CR ) and overall objective response ( OR ) . 181 patients were r and omized . A pCR was observed in 17 % ( 12/71 ) of patients treated with gefitinib and in 12 % ( 9/73 ) of patients treated with placebo ( 4.57 % difference , 95 % CI −7.19 to 6.33 ; P = 0.44 ) . CR was observed in 10 % of patients in both the gefitinib ( 7/71 ) and the placebo group ( 7/73 ) ( 0.27 % difference , 95 % CI −9.6 to 10.2 ; P = 0.96 ) . There was no significant difference in OR ( 5.96 % ; 95 % CI −9.9 to 21.9 ; P = 0.45 ) between the two groups . Post hoc subgroup analysis showed a significant difference in pCR between triple negative breast cancer ( TNBC ) and non-TNBC tumors ( P = 0.03 ) . More patients in the gefitinib arm had hematological toxicity ( P = 0.15 ) and discontinued treatment ( 9/94 vs. 2/86 ) because of adverse events ( AE ) . Tumor response rates were similar in the two groups . A significantly higher pCR rate was observed post hoc in TNBC versus non-TNBC independent of treatment . More patients in the gefitinib group discontinued treatment because of AE BACKGROUND We conducted a phase 3 , r and omized , double-blind , placebo-controlled trial of sorafenib , a multikinase inhibitor of tumor-cell proliferation and angiogenesis , in patients with advanced clear-cell renal-cell carcinoma . METHODS From November 2003 to March 2005 , we r and omly assigned 903 patients with renal-cell carcinoma that was resistant to st and ard therapy to receive either continuous treatment with oral sorafenib ( at a dose of 400 mg twice daily ) or placebo ; 451 patients received sorafenib and 452 received placebo . The primary end point was overall survival . A single planned analysis of progression-free survival in January 2005 showed a statistically significant benefit of sorafenib over placebo . Consequently , crossover was permitted from placebo to sorafenib , beginning in May 2005 . RESULTS At the January 2005 cutoff , the median progression-free survival was 5.5 months in the sorafenib group and 2.8 months in the placebo group ( hazard ratio for disease progression in the sorafenib group , 0.44 ; 95 % confidence interval [ CI ] , 0.35 to 0.55 ; P<0.01 ) . The first interim analysis of overall survival in May 2005 showed that sorafenib reduced the risk of death , as compared with placebo ( hazard ratio , 0.72 ; 95 % CI , 0.54 to 0.94 ; P=0.02 ) , although this benefit was not statistically significant according to the O'Brien-Fleming threshold . Partial responses were reported as the best response in 10 % of patients receiving sorafenib and in 2 % of those receiving placebo ( P<0.001 ) . Diarrhea , rash , fatigue , and h and -foot skin reactions were the most common adverse events associated with sorafenib . Hypertension and cardiac ischemia were rare serious adverse events that were more common in patients receiving sorafenib than in those receiving placebo . CONCLUSIONS As compared with placebo , treatment with sorafenib prolongs progression-free survival in patients with advanced clear-cell renal-cell carcinoma in whom previous therapy has failed ; however , treatment is associated with increased toxic effects . ( Clinical Trials.gov number , NCT00073307 [ Clinical Trials.gov ] . ) BACKGROUND Whether progression-free survival ( PFS ) or overall survival ( OS ) is the more appropriate endpoint in clinical trials of metastatic cancer is controversial . In some disease and treatment setting s , an improvement in PFS does not result in an improved OS . METHODS We partitioned OS into two parts and expressed it as the sum of PFS and survival postprogression ( SPP ) . We simulated r and omized clinical trials with two arms that had respective medians for PFS of 6 and 9 months . We assumed no treatment difference in median SPP . We found the probability of a statistically significant benefit in OS for various median SPP and observed P values for PFS . We compared the sample sizes required for PFS vs OS for various median SPP . We compare our results with the literature regarding surrogacy of PFS for OS by use of the correlation between hazard ratios for PFS and OS . All statistical tests were two-sided . RESULTS For a trial with observed P value for improvement in PFS of .001 , there was a greater than 90 % probability for statistical significance in OS if median SPP was 2 months but less than 20 % if median SPP was 24 months . For a trial requiring 280 patients to detect a 3-month difference in PFS , 350 and 2440 patients , respectively , were required to have the same power for detecting a real difference in OS that is carried over from the 3-month benefit in PFS when the median SPP was 2 and 24 months . CONCLUSIONS Addressing SPP is important in underst and ing treatment effects . For clinical trials with a PFS benefit , lack of statistical significance in OS does not imply lack of improvement in OS , especially for diseases with long median SPP . Although there may be no treatment effect on SPP , its variability so dilutes the OS comparison that statistical significance is likely lost . OS is a reasonable primary endpoint when median SPP is short but is too high a bar when median SPP is long , such as longer than 12 months In February 2008 , the U.S. Food and Drug Administration ( FDA ) granted accelerated approval to bevacizumab ( Avastin ) in combination with paclitaxel as first-line treatment for HER-2 negative metastatic breast cancer . Approval was based on the results of E2100 , a cooperative-group r and omized trial that showed a 5.5-month increase in progression-free survival associated with the addition of bevacizumab to paclitaxel therapy.1,2 Confirmatory studies by Genentech , the manufacturer , however , showed that bevacizumab 's benefits for progression-free survival may be appreciably smaller than those shown in E2100 and have demonstrated convincingly that the addition of bevacizumab to the chemotherapy agents they have tested offers no . .
Output:
| No effect on OS was observed .
No PFS and OS benefit was detected with the other agents .
No improvement of OS was detected in patients treated with biological agents plus chemotherapy , while a significant PFS improvement was observed only for bevacizumab and cetuximab . |
MS213533 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: There have been cl aims that the postoperative course of patients may be improved by presentation during general anesthesia of therapeutic suggestions which predict a rapid and comfortable postoperative recovery . This study evaluated the effectiveness of such therapeutic suggestions under double-blind and r and omized conditions . A tape recording predicting a smooth recovery during a short postoperative stay without pain , nausea , or vomiting was played during anesthesia to about half the patients ( N = 109 ) , while the remaining , control patients were played a blank tape instead ( N = 100 ) . The patients were primarily undergoing operations on the fallopian tubes , total abdominal hysterectomy , vertical b and ing gastroplasty , cholecystectomy , and ovarian cystectomy or myomectomy . The anesthesia methods consisted of either isoflurane with 70 % nitrous oxide in oxygen to produce end-tidal concentrations of 1.0 , 1.3 , or 1.5 MAC ; or 70 % nitrous oxide in oxygen combined with high or low doses of opioids . Assessment s of the efficacy of the therapeutic suggestions in the recovery room and throughout the postoperative hospital stay included : the frequency of administration of analgesic and antiemetic drugs ; opioid doses ; the incidence of fever ; nausea , retching , and vomiting ; other gastrointestinal and urinary symptoms ; ratings of pain ; ratings of anxiety ; global ratings of the patients ' physical and psychological recoveries by the patients and their nurses ; and length of postoperative hospital stay . There were no meaningful , significant differences in postoperative recovery of patients receiving therapeutic suggestions and controls . These negative results were not likely to be due to insensitivity of the assessment s of recovery , as they showed meaningful interrelations among themselves and numerous differences in recovery following different types of surgery . Widespread utilization of therapeutic suggestions as a routine operating room procedure seems premature in the absence of adequate replication of previously published positive studies Immediately before they underwent femoral angiography , 45 patients were given one of three types of audiotapes : a relaxation response tape recorded for this study , a tape of contemporary instrumental music , or a blank tape . All patients were instructed to listen to their audiotape during the entire angiographic procedure . Each audiotape was played through earphones . Radiologists were not told the group assignment or tape contents . The patients given the audiotape with instructions to elicit the relaxation response ( n = 15 ) experienced significantly less anxiety ( P less than .05 ) and pain ( P less than .001 ) during the procedure , were observed by radiology nurses to exhibit significantly less pain ( P less than .001 ) and anxiety ( P less than .001 ) , and requested significantly less fentanyl citrate ( P less than .01 ) and diazepam ( P less than .01 ) than patients given either the music ( n = 14 ) or the blank ( n = 16 ) control audiotapes . Elicitation of the relaxation response is a simple , inexpensive , efficacious , and practical method to reduce pain , anxiety , and medication during femoral angiography and may be useful in other invasive procedures CONTEXT Previous studies on the effect of mindfulness-based stress reduction ( MBSR ) therapy on chronic pain syndromes have been hampered by study design . OBJECTIVE To evaluate short-term efficacy of MBSR therapy for improving quality of life in adults with failed back surgery syndrome ( FBSS ) . DESIGN A single-center , prospect i ve , r and omized , single-blind , parallel-group clinical trial . PATIENTS AND SETTING Participants were recruited from a multidisciplinary spine and rehabilitation center in the greater Portl and , Maine , area . INTERVENTIONS AND MAIN OUTCOME MEASURES Patients were r and omly assigned at baseline to receive either MBSR therapy plus traditional therapy or traditional therapy alone for an 8-week period . Those receiving MBSR therapy completed weekly group sessions , and the control group continued with their traditional care as prescribed by their medical care providers . At study enrollment and at 12-week follow-up , all participants completed question naires on pain , quality of life , functionality , analgesic use , and sleep quality . Patients in the intervention group also completed question naires at 40-week follow-up . RESULTS The final analysis included 25 patients with FBSS ; 15 patients were in the MBSR intervention arm , and 10 in the control group . At 12-week follow-up , patients in the intervention arm had a mean 7.0-point increase ( on an 108-point [ corrected ] scale ) in pain acceptance and quality of life on the Chronic Pain Assessment Question naire , a mean 3.6-point [ corrected ] decrease ( on a 24-point scale ) in functional limitation on the Rol and -Morris Disability Question naire , a mean 6.9-point [ corrected ] reduction ( on a 30-point scale ) in pain level on the Summary Visual Analog Scale for Pain , a mean 1.5-point [ corrected ] reduction ( on a 4-point scale ) in frequency of use and potency of analgesics used for pain and recorded on logs , and a mean 2.0-point [ corrected ] increase ( on a 5-point scale ) in sleep quality on the abridged Pittsburgh Sleep Quality Inventory . These results were statistically and clinical ly significant compared to outcomes for the control group . CONCLUSION The results suggest that MBSR can be a useful clinical intervention for patients with FBSS A prospect i ve study was design ed to compare two psychological support interventions in controlling peri-dressing change pain and anxiety in severely burned patients . Thirty patients with a total burned surface area of 10 - 25 % , requiring a hospital stay of at least 14 days , were r and omised to receive either hypnosis or stress reducing strategies ( SRS ) adjunctively to routine intramuscular pre-dressing change analgesia and anxiolytic drugs . Visual analogue scale ( VAS ) scores for anxiety , pain , pain control and satisfaction were recorded at 2-day intervals throughout the 14-day study period , before , during and after dressing changes . The psychological assistance was given on days 8 and 10 after hospital admission . The comparison of the two treatment groups indicated that VAS anxiety scores were significantly decreased before and during dressing changes when the hypnotic technique was used instead of SRS . No difference was observed for pain , pain control and satisfaction , although VAS scores were always better in the hypnosis group . The study also showed that , overall , psychological support interventions reduced pain and increased patient satisfaction . These results confirm the potential benefits of psychological assistance during dressing changes in burned patients Background Medical management of acute pain among hospital in patients may be enhanced by mind-body interventions . Objective We hypothesized that a single , scripted session of mindfulness training focused on acceptance of pain or hypnotic suggestion focused on changing pain sensations through imagery would significantly reduce acute pain intensity and unpleasantness compared to a psychoeducation pain coping control . We also hypothesized that mindfulness and suggestion would produce significant improvements in secondary outcomes including relaxation , pleasant body sensations , anxiety , and desire for opioids , compared to the control condition . Methods This three-arm , parallel-group r and omized controlled trial conducted at a university-based hospital examined the acute effects of 15-min psychosocial interventions ( mindfulness , hypnotic suggestion , psychoeducation ) on adult in patients reporting “ intolerable pain ” or “ inadequate pain control . ” Participants ( N = 244 ) were assigned to one of three intervention conditions : mindfulness ( n = 86 ) , suggestion ( n = 73 ) , or psychoeducation ( n = 85).Key Results Participants in the mind-body interventions reported significantly lower baseline-adjusted pain intensity post-intervention than those assigned to psychoeducation ( p < 0.001 , percentage pain reduction : mindfulness = 23 % , suggestion = 29 % , education = 9 % ) , and lower baseline-adjusted pain unpleasantness ( p < 0.001 ) . Intervention conditions differed significantly with regard to relaxation ( p < 0.001 ) , pleasurable body sensations ( p = 0.001 ) , and desire for opioids ( p = 0.015 ) , but all three interventions were associated with a significant reduction in anxiety ( p < 0.001 ) . Conclusions Brief , single-session mind-body interventions delivered by hospital social workers led to clinical ly significant improvements in pain and related outcomes , suggesting that such interventions may be useful adjuncts to medical pain management . Trial registration Trial Registry : Clinical Trials.gov ; registration ID number : NCT02590029URL : https:// clinical OBJECTIVE The purpose of this study was to determine whether hypnotic analgesia can reduce the need for intravenous sedation analgesia without increasing pain and anxiety levels during abortion . STUDY DESIGN A cohort of 350 women who were scheduled for surgical abortion ( < 14 weeks ' gestation ) were assigned r and omly to a st and ard care group or a group that received a st and ardized hypnotic analgesia intervention 20 minutes before and throughout the surgical procedure . Primary outcome was the difference between the 2 groups : ( 1 ) the proportion who received sedation ( yes/no ) during the surgical procedure and ( 2 ) self- assessment s of pain and anxiety during suction evacuation of uterus content . RESULTS Women who underwent hypnosis required less intravenous sedation analgesia ( 108/172 women ; 63 % ) than the control group ( 149/175 women ; 85 % ; P < .0001 ) and self-reported no difference in pain , but not in anxiety , levels during suction evacuation . CONCLUSION Hypnotic interventions can be effective as an adjunct to pharmacologic management of acute pain during abortion The effects of hypnosis/therapeutic suggestion in connection with intravenous sedation and surgery have been described in many clinical publications ; however , few r and omized , controlled , and blind studies have been performed in the outpatient area . The original study published in 2010 aim ed to evaluate the use of hypnosis/therapeutic suggestion as an adjunct to intravenous sedation in patients having third molar removal in an outpatient setting . The patients were r and omly assigned to a treatment or control group . The treatment group listened to a rapid conversational induction and therapeutic suggestions via headphones throughout the entire surgical procedure along with a st and ard sedation dose of intravenous anesthetic . The control group received intravenous anesthesia but listened to only music without any hypnotic intervention . The current replication study addressed several of the limitations of the original . Sample size was increased and selection of participants from a different geographic area in Pennsylvania . Intra-operative propofol administration , patient post-operative pain ratings , and post-operative prescription pain reliever consumption were all significantly reduced in the treatment compared to the control group . Implication s of these results are discussed Background Catastrophic thinking and fear-avoidance belief are negatively influencing severe acute pain following surgery causing delayed ambulation and discharge . We aim ed to examine if a preoperative intervention of cognitive-behavioural therapy ( CBT ) could influence the early postsurgical outcome following lumbar spinal fusion surgery ( LSF ) . Methods Ninety patients undergoing LSF due to degenerative spinal disorders were r and omly allocated to either the CBT group or the control group . Both groups received surgery and postoperative rehabilitation . In addition , the CBT group received a preoperative intervention focussed on pain coping using a CBT approach . Primary outcome was back pain during the first week ( 0–10 scale ) . Secondary outcomes were mobility , analgesic consumption , and length of hospitalisation . Data were retrieved using self-report question naires , assessment s made by physical therapists and from medical records . Results No difference between the groups ’ self-reported back pain ( p = 0.76 ) was detected . Independent mobility was reached by a significantly larger number of patients in the CBT group than the control group during the first three postoperative days . Analgesic consumption tended to be lower in the CBT group , whereas length of hospitalisation was unaffected by the CBT intervention . Conclusion Participation in a preoperative CBT intervention appeared to facilitate mobility in the acute postoperative phase , despite equally high levels of self-reported acute postsurgical pain in the two groups , and a slightly lower intake of rescue analgesics in the CBT group . This may reflect an overall improved ability to cope with pain following participation in the preoperative CBT intervention . Trial registration The study was approved by the Danish Protection Agency ( 2011 - 41 - 5899 ) and the Ethics Committee of the Central Denmark Region ( M-20110047 ) . The trial was registered in Current Controlled Trials ( IS RCT N42281022 ) BACKGROUND Breast cancer surgery is associated with side effects , including postsurgical pain , nausea , and fatigue . We carried out a r and omized clinical trial to test the hypotheses that a brief presurgery hypnosis intervention would decrease intraoperative anesthesia and analgesic use and side effects associated with breast cancer surgery and that it would be cost effective . METHODS We r and omly assigned 200 patients who were scheduled to undergo excisional breast biopsy or lumpectomy ( mean age 48.5 years ) to a 15-minute presurgery hypnosis session conducted by a psychologist or nondirective empathic listening ( attention control ) . Patients were not blinded to group assignment . Intraoperative anesthesia use ( i.e. , of the analgesics lidocaine and fentanyl and the sedatives propofol and midazolam ) was assessed . Patient-reported pain and other side effects as measured on
Output:
| Conclusions and Relevance The findings suggest that MBTs are associated with moderate improvements in pain and small reductions in opioid dose and may be associated with therapeutic benefits for opioid-related problems , such as opioid craving and misuse . |
MS213534 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Oropharyngeal squamous-cell carcinomas caused by human papillomavirus ( HPV ) are associated with favorable survival , but the independent prognostic significance of tumor HPV status remains unknown . METHODS We performed a retrospective analysis of the association between tumor HPV status and survival among patients with stage III or IV oropharyngeal squamous-cell carcinoma who were enrolled in a r and omized trial comparing accelerated-fractionation radiotherapy ( with acceleration by means of concomitant boost radiotherapy ) with st and ard-fractionation radiotherapy , each combined with cisplatin therapy , in patients with squamous-cell carcinoma of the head and neck . Proportional-hazards models were used to compare the risk of death among patients with HPV-positive cancer and those with HPV-negative cancer . RESULTS The median follow-up period was 4.8 years . The 3-year rate of overall survival was similar in the group receiving accelerated-fractionation radiotherapy and the group receiving st and ard-fractionation radiotherapy ( 70.3 % vs. 64.3 % ; P=0.18 ; hazard ratio for death with accelerated-fractionation radiotherapy , 0.90 ; 95 % confidence interval [ CI ] , 0.72 to 1.13 ) , as were the rates of high- grade acute and late toxic events . A total of 63.8 % of patients with oropharyngeal cancer ( 206 of 323 ) had HPV-positive tumors ; these patients had better 3-year rates of overall survival ( 82.4 % , vs. 57.1 % among patients with HPV-negative tumors ; P<0.001 by the log-rank test ) and , after adjustment for age , race , tumor and nodal stage , tobacco exposure , and treatment assignment , had a 58 % reduction in the risk of death ( hazard ratio , 0.42 ; 95 % CI , 0.27 to 0.66 ) . The risk of death significantly increased with each additional pack-year of tobacco smoking . Using recursive-partitioning analysis , we classified our patients as having a low , intermediate , or high risk of death on the basis of four factors : HPV status , pack-years of tobacco smoking , tumor stage , and nodal stage . CONCLUSIONS Tumor HPV status is a strong and independent prognostic factor for survival among patients with oropharyngeal cancer . ( Clinical Trials.gov number , NCT00047008 . The purpose of the current study was to determine quality of life and tumor control from a prospect i ve phase 2 clinical trial evaluating deintensified chemoradiotherapy for favorable risk , human papillomavirus (HPV)‐associated oropharyngeal squamous cell carcinoma Purpose Chemoradiation with cisplatin 100 mg/m2 given once every 3 weeks is the st and ard of care in locally advanced head and neck squamous cell cancer ( LAHNSCC ) . Increasingly , low-dose once-a-week cisplatin is substituted because of perceived lower toxicity and convenience . However , there is no level 1 evidence of comparable efficacy to cisplatin once every 3 weeks . Patients and Methods In this phase III r and omized trial , we assessed the noninferiority of cisplatin 30 mg/m2 given once a week compared with cisplatin 100 mg/m2 given once every 3 weeks , both administered concurrently with curative intent radiotherapy in patients with LAHNSCC . The primary end point was locoregional control ( LRC ) ; secondary end points included toxicity , compliance , response , progression-free survival , and overall survival . Results Between 2013 and 2017 , we r and omly assigned 300 patients , 150 to each arm . Two hundred seventy-nine patients ( 93 % ) received chemoradiotherapy in the adjuvant setting . At a median follow-up of 22 months , the estimated cumulative 2-year LRC rate was 58.5 % in the once-a-week arm and 73.1 % in the once-every-3-weeks arm , leading to an absolute difference of 14.6 % ( 95 % CI , 5.7 % to 23.5 % ) ; P = .014 ; hazard ratio ( HR ) , 1.76 ( 95 % CI , 1.11 to 2.79 ) . Acute toxicities of grade 3 or higher occurred in 71.6 % of patients in the once-a-week arm and in 84.6 % of patients in the once-every-3-weeks arm ( P = .006 ) . Estimated median progression-free survival in the once-a-week arm was 17.7 months ( 95 % CI , 0.42 to 35.05 months ) and in the once-every-3-weeks arm , 28.6 months ( 95 % CI , 15.90 to 41.30 months ) ; HR , 1.24 ( 95 % CI , 0.89 to 1.73 ) ; P = .21 . Estimated median overall survival in the once-a-week arm was 39.5 months and was not reached in the once-every-3-weeks arm ( HR , 1.14 [ 95 % CI , 0.79 to 1.65 ] ; P = .48 ) . Conclusion Once-every-3-weeks cisplatin at 100 mg/m2 result ed in superior LRC , albeit with more toxicity , than did once-a-week cisplatin at 30 mg/m2 , and should remain the preferred chemoradiotherapy regimen for LAHNSCC in the adjuvant setting BACKGROUND The relative efficacy of the addition of induction chemotherapy to chemoradiotherapy compared with chemoradiotherapy alone for patients with head and neck cancer is unclear . The PARADIGM study is a multicentre open-label phase 3 study comparing the use of docetaxel , cisplatin , and fluorouracil ( TPF ) induction chemotherapy followed by concurrent chemoradiotherapy with cisplatin-based concurrent chemoradiotherapy alone in patients with locally advanced head and neck cancer . METHODS Adult patients with previously untreated , non-metastatic , newly diagnosed head and neck cancer were eligible . Patients were eligible if their tumour was either unresectable or of low surgical curability on the basis of advanced tumour stage ( 3 or 4 ) or regional-node stage ( 2 or 3 , except T1N2 ) , or if they were a c and i date for organ preservation . Patients were r and omly assigned ( in a 1:1 ratio ) to receive either induction chemotherapy with three cycles of TPF followed by concurrent chemoradiotherapy with either docetaxel or carboplatin or concurrent chemoradiotherapy alone with two cycles of bolus cisplatin . A computer-generated r and omisation schedule using minimisation was prepared and the treatment assignment was done central ly at one of the study sites . Patients , study staff , and investigators were not masked to group assignment . Stratification factors were WHO performance status , primary disease site , and stage . The primary endpoint was overall survival . Analysis was by intention to treat . Patient accrual was terminated in December , 2008 , because of slow enrolment . The trial is registered with Clinical Trials.gov , number NCT00095875 . FINDINGS Between Aug 24 , 2004 , and Dec 29 , 2008 , we enrolled 145 patients across 16 sites . After a median follow-up of 49 months ( IQR 39 - 63 ) , 41 patients had died-20 in the induction chemotherapy followed by chemoradiotherapy group and 21 in the chemoradiotherapy alone group . 3-year overall survival was 73 % ( 95 % CI 60 - 82 ) in the induction therapy followed by chemoradiotherapy group and 78 % ( 66 - 86 ) in the chemoradiotherapy alone group ( hazard ratio 1·09 , 95 % CI 0·59 - 2·03 ; p=0·77 ) . More patients had febrile neutropenia in the induction chemotherapy followed by chemoradiotherapy group ( 16 patients ) than in the chemoradiotherapy alone group ( one patient ) . INTERPRETATION Although survival results were good in both groups there was no difference noted between those patients treated with induction chemotherapy followed by chemoradiotherapy and those who received chemoradiotherapy alone . We can not rule out the possibility of a difference in survival going undetected due to early termination of the trial . Clinicians should still use their best judgment , based on the available data , in the decision of how to best treat patients . The addition of induction chemotherapy remains an appropriate approach for advanced disease with high risk for local or distant failure . FUNDING Sanofi-Aventis PURPOSE Induction chemotherapy ( IC ) before radiotherapy lowers distant failure ( DF ) rates in locally advanced squamous cell carcinoma of the head and neck ( SCCHN ) . The goal of this phase III trial was to determine whether IC before chemoradiotherapy ( CRT ) further improves survival compared with CRT alone in patients with N2 or N3 disease . PATIENTS AND METHODS Treatment-naive patients with nonmetastatic N2 or N3 SCCHN were r and omly assigned to CRT alone ( CRT arm ; docetaxel , fluorouracil , and hydroxyurea plus radiotherapy 0.15 Gy twice per day every other week ) versus two 21-day cycles of IC ( docetaxel 75 mg/m(2 ) on day 1 , cisplatin 75 mg/m(2 ) on day 1 , and fluorouracil 750 mg/m(2 ) on days 1 to 5 ) followed by the same CRT regimen ( IC + CRT arm ) . The primary end point was overall survival ( OS ) . Secondary end points included DF-free survival , failure pattern , and recurrence-free survival ( RFS ) . RESULTS A total of 285 patients were r and omly assigned . The most common grade 3 to 4 toxicities during IC were febrile neutropenia ( 11 % ) and mucositis ( 9 % ) ; during CRT ( both arms combined ) , they were mucositis ( 49 % ) , dermatitis ( 21 % ) , and leukopenia ( 18 % ) . Serious adverse events were more common in the IC arm ( 47 % v 28 % ; P = .002 ) . With a minimum follow-up of 30 months , there were no statistically significant differences in OS ( hazard ratio , 0.91 ; 95 % CI , 0.59 to 1.41 ) , RFS , or DF-free survival . CONCLUSION IC did not translate into improved OS compared with CRT alone . However , the study was underpowered because it did not meet the planned accrual target , and OS was higher than predicted in both arms . IC can not be recommended routinely in patients with N2 or N3 locally advanced SCCHN BACKGROUND Concurrent chemoradiotherapy ( CCRT ) is the st and ard treatment for patients with unresectable , nonmetastatic locoregionally advanced squamous-cell carcinoma of the head and neck ( LASCCHN ) . This r and omized , open-label , phase III clinical trial compared the efficacy between st and ard CCRT and two different induction chemotherapy ( ICT ) regimens followed by CCRT . PATIENTS AND METHODS Patients with untreated LASCCHN were r and omly assigned to ICT ( three cycles ) , with either docetaxel ( Taxotere ) , cisplatin and 5-fluorouracil ( TPF arm ) or cisplatin and 5-fluorouracil ( PF arm ) , followed by CCRT [ 7 weeks of radiotherapy ( RT ) with cisplatin 100 mg/m(2 ) on days 1 , 22 and 43 ] ; or 7 weeks of CCRT alone . The primary end points were progression-free survival ( PFS ) and time-to-treatment failure ( TTF ) . RESULTS In the intention-to-treat ( ITT ) population ( n = 439 ) , the median PFS times were 14.6 ( 95 % CI , 11.6 - 20.4 ) , 14.3 ( 95 % CI , 11.8 - 19.3 ) and 13.8 months ( 95 % CI , 11.0 - 17.5 ) at TPF-CCRT , PF-CCRT and CCRT arms , respectively ( log-rank P = 0.56 ) . The median TTF were 7.9 ( 95 % CI , 5.9 - 11.8 ) , 7.9 ( 95 % CI , 6.5 - 11.8 ) and 8.2 months ( 95 % CI , 6.7 - 12.6 ) for TPF-CCRT , PF-CCRT and CCRT alone , respectively ( log-rank P = 0.90 ) . There were no statistically significant differences for overall survival ( OS ) . Toxic effects from ICT-CCRT were manageable . CONCLUSION Overall , this trial failed to show any advantage of ICT-CCRT over CCRT alone in patients with unresectable LASCCHN Purpose Human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma ( OPSCC ) is treatment-responsive . Definitive chemoradiation results in high cure rates but causes long-term toxicity and may represent overtreatment of some patients . This phase II trial evaluated
Output:
| Taken together , dose-reduced chemoradiotherapy ( with or without induction chemotherapy for patient/biology selection purpose s ) seems to be a promising de-escalation strategy for HPV-associated OPC , although replacement of concurrent cisplatin by cetuximab is not recommended . |
MS213535 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Brief interventions for problem drinking in medical setting s are effective but rarely conducted , mainly due to insufficient time . A stepped care approach ( starting with a very brief intervention and intensifying efforts in case of no success ) could save re sources and enlarge effectiveness ; however , research is lacking . The present study compares a full care brief intervention for patients with at-risk drinking , alcohol abuse or dependence with a stepped care approach in a r and omized controlled trial . METHODS Participants were proactively recruited from general practice s in two northern German cities . In total , 10,803 screenings were conducted ( refusal rate : 5 % ) . Alcohol use disorders according to DSM-IV were assessed with the Munich-Composite International Diagnostic Interview ( M-CIDI ) . Eligible participants were r and omly assigned to one of three conditions : ( 1 ) stepped care ( SC ) : a computerized intervention plus up to three 40-min telephone-based interventions depending on the success of the previous intervention ; ( 2 ) full-care ( FC ) : a computerized intervention plus a fixed number of four 30-min telephone-based interventions that equals the maximum of the stepped care intervention ; ( 3 ) an untreated control group ( CG ) . Counseling effort in the intervention conditions and quantity/frequency of drinking were assessed at 12-month follow-up . RESULTS SC participants received roughly half of the amount of intervention in minutes compared to FC participants . Both groups did not differ in drinking outcomes . Compared to CG , intervention showed small to medium effect size for at-risk drinkers . CONCLUSIONS Study results reveal that a stepped care approach can be expected to increase cost-effectiveness of brief interventions for individuals with at-risk drinking AIM To establish the efficacy of a brief motivational intervention compared to feedback only when delivered in an emergency department for reducing alcohol use and problems among young adults . DESIGN Two-group r and omized controlled trial with follow-up assessment s at 6 and 12 months . SETTING Level I Trauma Center . PARTICIPANTS A total of 198 18 - 24-year-old patients who were either alcohol positive upon hospital admission or met screening criteria for alcohol problems . INTERVENTION Participants were assigned r and omly to receive a one-session motivational intervention ( MI ) that included personalized feedback , or the personalized feedback report only ( FO ) . All participants received additional telephone contact 1 month and 3 months after baseline . MEASUREMENTS Demographic information , alcohol use , alcohol problems and treatment seeking . FINDINGS Six months after the intervention MI participants drank on fewer days , had fewer heavy drinking days and drank fewer drinks per week in the past month than did FO patients . These effects were maintained at 12 months . Clinical significance evaluation indicated that twice as many MI participants as FO participants reliably reduced their volume of alcohol consumption from baseline to 12 months . Reductions in alcohol-related injuries and moving violations , and increases in alcohol treatment-seeking were observed across both conditions at both follow-ups with no differences between conditions . CONCLUSIONS This study provides new data supporting the potential of the motivational intervention tested to reduce alcohol consumption among high-risk youth BACKGROUND Risky driving and hazardous drinking are associated with significant human and economic costs . Brief interventions for more than one risky behavior have the potential to reduce health-compromising behaviors in population s with multiple risk-taking behaviors such as young adults . Emergency department ( ED ) visits provide a window of opportunity for interventions meant to reduce both risky driving and hazardous drinking . METHODS We determined the efficacy of a Screening , Brief Intervention , and Referral to Treatment ( SBIRT ) protocol addressing risky driving and hazardous drinking . We used a r and omized controlled trial design with follow-ups through 12 months . ED patients aged 18 to 44 who screened positive for both behaviors ( n = 476 ) were r and omized to brief intervention ( BIG ) , contact control ( CCG ) , or no-contact control ( NCG ) groups . The BIG ( n = 150 ) received a 20-minute assessment and two 20-minute interventions . The CCG ( n = 162 ) received a 20-minute assessment at baseline and no intervention . The NCG ( n = 164 ) were asked for contact information at baseline and had no assessment or intervention . Outcomes at 3 , 6 , 9 , and 12 months were self-reported driving behaviors and alcohol consumption . RESULTS Outcomes were significantly lower in BIG compared with CCG through 6 or 9 months , but not at 12 months : Safety belt use at 3 months ( adjusted odds ratio [ AOR ] , 0.22 ; 95 % confidence interval [ CI ] , 0.08 to 0.65 ) ; 6 months ( AOR , 0.13 ; 95 % CI , 0.04 to 0.42 ) ; and 9 months ( AOR , 0.18 ; 95 % CI , 0.06 to 0.56 ) ; binge drinking at 3 months ( adjusted rate ratio [ ARR ] 0.84 ; 95 % CI , 0.74 to 0.97 ) and 6 months ( ARR , 0.81 ; 95 % CI , 0.67 to 0.97 ) ; and ≥5 st and ard drinks/d at 3 months ( AOR , 0.43 ; 95 % CI , 0.20 to 0.91 ) and 6 months ( AOR , 0.41 ; 95 % CI , 0.17 to 0.98 ) . No substantial differences were observed between BIG and NCG at 12 months . CONCLUSIONS Our findings indicate that SBIRT reduced risky driving and hazardous drinking in young adults , but its effects did not persist after 9 months . Future research should explore methods for extending the intervention effect OBJECTIVE This study was design ed to conduct a r and omized controlled trial of motivational enhancement therapy ( MET ) with two control conditions : nondirective reflective listening ( NDRL ) and no further counseling ( NFC ) ; and to conduct this study in a sample of patients with a primary diagnosis of mild to moderate alcohol dependence , in a " real-life " clinical setting . METHOD Patients with mild to moderate alcohol dependence were recruited , assessed and treated at the Community Alcohol and Drug Service of Christchurch , New Zeal and . All patients received a feedback/education session before r and omization to either four sessions of MET , four sessions of NDRL , or NFC . Outcome data on 122 subjects ( 57.4 % men ) were obtained 6 months following the end of treatment , by an interviewer who was blind to the treatment condition . The primary drinking outcome was unequivocal heavy drinking , defined as drinking 10 or more st and ard drinks six or more times in the follow-up period . Global assessment scale ( GAS ) measured general personal/social functioning . RESULTS Of patients treated with MET , 42.9 % showed unequivocal heavy drinking compared with 62.5 % of the NDRL and 65.0 % of the NFC groups ( p = .04 ) . No significant differences were found for GAS score according to treatment condition . CONCLUSIONS In patients with mild to moderate alcohol dependence , MET is more effective for reducing unequivocal heavy drinking than either a feedback/education session alone or four sessions of NDRL . MET can be considered an effective " value added " counseling intervention in a real-life clinical setting . In patients with mild to moderate alcohol dependence , nondirective reflective listening provides no additional advantage over a feedback/education session alone BACKGROUND Patient involvement in the decision-making process is a key element for good clinical practice . Few data are available on patient involvement in psychiatry . AIMS To assess in a psychiatric out-patient context how psychiatrists involve patients in therapeutic decisions and to determine the extent to which patient and psychiatrist characteristics contribute to patient involvement . METHOD Eighty transcripts from audiotaped first out-patient consultations , conducted by 16 psychiatrists , were rated with the OPTION ( observing patient involvement ) scale . Interrater reliability indices were obtained for 30 r and omly selected interviews . Associations between OPTION scores and some clinical and socio-demographic variables were tested using t-test , ANOVA and Pearson 's correlation coefficient where appropriate . The distribution of scores for each psychiatrist was assessed by intracluster correlation coefficients . RESULTS Interrater reliability and internal consistency of the OPTION scale in the psychiatric setting were satisfactory . The total score and the ratings for the single OPTION items showed a skewed distribution , with a prevalence of scores in the low range of abilities , corresponding to minimal attempts to involve patients or a minimal skill level . CONCLUSIONS The OPTION scale proves to be a reliable instrument to assess patient involvement in a psychiatric setting . Psychiatrists showed poor patient involvement abilities parallel to previous findings in psychiatry and primary care . They need to be encouraged to share treatment decisions with their patients and to apply patient involvement skills . Further research is needed to establish which patient variables and clinical setting s in psychiatry are more amenable to shared decisions , and how participation of psychiatric patients in treatment decisions will affect the outcome This study evaluated the efficacy of as-needed use of the opioid system modulator nalmefene in reducing alcohol consumption in patients with alcohol dependence . Seven hundred and eighteen patients ( placebo=360 ; nalmefene=358 ) , ≥ 18 years of age , with a diagnosis of alcohol dependence , ≥ 6 heavy drinking days and an average alcohol consumption ≥ WHO medium drinking risk level in the 4 weeks preceding screening , were r and omised ( 1:1 ) to 24 weeks of as-needed placebo or nalmefene 18 mg/day . The co- primary efficacy analyses showed a significantly superior effect of nalmefene compared to placebo in the change from baseline to month 6 in heavy drinking days ( group difference : -1.7 days/month [ 95 % CI -3.1 ; -0.4 ] ; p=0.012 ) and a better but not significant effect in reducing total alcohol consumption ( group difference : -5.0 g/day last month [ 95 % CI -10.6 ; 0.7 ] ; p=0.088 ) . A subgroup analysis showed that patients who did not reduce their drinking prior to r and omisation benefitted more from nalmefene . Improvements in Clinical Global Impression and reductions in liver enzymes were greater in the nalmefene group than in the placebo group . Adverse events were more common with nalmefene ; the incidence of adverse events leading to dropout was similar in both groups . This study provides evidence for the efficacy of nalmefene , which constitutes a new pharmacological treatment paradigm in terms of treatment goal ( reduced drinking ) and dosing regimen ( as-needed ) , in alcohol dependent patients unable to reduce alcohol consumption on their own The relationship between individuals ' choice of abstinence or moderate drinking during outpatient behavioral management treatment and outcome over 12 months ' posttreatment was examined . At the initial assessment , 46 % of 106 chronic alcoholic subjects chose abstinence , 44 % chose moderate drinking , and 9 % were unsure . Over the course of treatment , subjects were more likely to move from moderation to abstinence goals , and after the first 4 weeks of treatment , two-thirds chose abstinence . These subjects were older , had more severe alcohol problems ( i.e. , higher MAST scores ) , and were more likely to maintain their weekly alcohol consumption goals during the 16-week treatment period . Moreover , these subjects reported less alcohol use in the 12 month follow-up period , and a greater proportion were judged as having successful outcomes . The implication s of these findings are discussed BACKGROUND Heavy drinking is one of the leading causes of morbidity and mortality in young men . Brief motivational intervention ( BMI ) has shown promising results for young people , but has never been tested in young men in the community who volunteered to receive an intervention . METHODS We evaluated the effectiveness of BMI in reducing alcohol use among heavy episodic users and in maintaining low-risk drinking among nonheavy episodic users . Participants were French-speaking young men attending the m and atory Swiss army conscription process . They were offered the opportunity to receive a 20-minute BMI , and those interested were r and omized into an intervention group ( BMI immediately ) or into a control group ( BMI after the 6-month follow-up assessment , in a waiting list design ) . Analyses were conducted separately for heavy and nonheavy episodic users ( separated using baseline heavy episodic use frequency ) as the hypotheses tested were different between both groups ( primary vs. secondary prevention intervention ) . RESULTS From a pool of 6,085 young men invited to receive BMI , 727 ( 11.9 % ) showed up and 572 were included in the study ( after exclusions related to organizational aspects of the conscription process ) . Among nonheavy episodic users , there was a protective effect of BMI on weekly alcohol use ( p < 0.05 ) . Among heavy episodic users , there were no significant effects of BMI . CONCLUSIONS About 12 % of young men were interested in addressing their drinking within the BMI framework , suggesting that there is some need for easily accessible alcohol intervention . The present intervention did have a preventive effect among low-risk young drinkers in helping them maintain their patterns of alcohol use . An explanation for the lack of effectiveness among heavy episodic users might be that those individuals interested in BMI had patterns of more severe alcohol use , thereby making change more difficult Background Russia has particularly low life expectancy for an industrialised country , with mortality at working ages having fluctuated dramatically over
Output:
| Results from single sessions of motivational interviewing showed no clear benefit on alcohol consumption outcomes , with few studies indicating benefit of PCC versus control .
Although the results for studies of multiple sessions of counseling were also mixed , many did show a significant benefit of the PCC intervention .
By contrast , studies consistently demonstrated a benefit of pharmacologically supported PCC interventions , with most of the differences reaching statistical significance .
IMPLICATION S PCC-based interventions may be beneficial for reducing alcohol consumption in people with alcohol use disorders |
MS213536 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To determine the effectiveness of structured adherence counseling by pharmacists on the eradication of Helicobacter pylori when using a st and ard drug treatment regimen . DESIGN R and omized controlled clinical trial . SETTING Nonprofit group- practice health maintenance organization ( HMO ) . PARTICIPANTS HMO primary care providers referred 1,393 adult dyspeptic patients for carbon 14 urea breath testing ( UBT ) . INTERVENTIONS Those whose tests were positive for H pylori ( 23.3 % ) were provided a st and ard antibiotic regimen and r and omly assigned to receive either usual-care counseling from a pharmacist or a longer adherence counseling session and a follow-up phone call from the pharmacist during drug treatment . All subjects were given the same 7-day course of omeprazole , bismuth subsalicylate , metronidazole , and tetracycline hydrochloride ( OBMT ) . Dyspepsia symptoms were recorded at baseline and following therapy . OUTCOMES The main outcome was eradication of H pylori as measured by UBT at 3-month follow-up . Secondary outcomes were patient satisfaction and dyspepsia symptoms at 3-month follow-up . RESULTS Of the 333 participants r and omly assigned to treatment , 90.7 % completed the 3-month follow-up UBT and question naires . Overall eradication rate with the OBMT regimen was 80.5 % with no significant difference in eradication rates between the 2 groups ( P=0.98 ) . Conclusions In this study , additional counseling by pharmacists did not affect self-reported adherence to the treatment regimen , eradication rates , or dyspepsia symptoms but did increase patient satisfaction BACKGROUND Hospitalization and subsequent discharge home often involve discontinuity of care , multiple changes in medication regimens , and inadequate patient education , which can lead to adverse drug events ( ADEs ) and avoidable health care utilization . Our objectives were to identify drug-related problems during and after hospitalization and to determine the effect of patient counseling and follow-up by pharmacists on preventable ADEs . METHODS We conducted a r and omized trial of 178 patients being discharged home from the general medicine service at a large teaching hospital . Patients in the intervention group received pharmacist counseling at discharge and a follow-up telephone call 3 to 5 days later . Interventions focused on clarifying medication regimens ; review ing indications , directions , and potential side effects of medications ; screening for barriers to adherence and early side effects ; and providing patient counseling and /or physician feedback when appropriate . The primary outcome was rate of preventable ADEs . RESULTS Pharmacists observed the following drug-related problems in the intervention group : unexplained discrepancies between patients ' preadmission medication regimens and discharge medication orders in 49 % of patients , unexplained discrepancies between discharge medication lists and postdischarge regimens in 29 % of patients , and medication nonadherence in 23 % . Comparing trial outcomes 30 days after discharge , preventable ADEs were detected in 11 % of patients in the control group and 1 % of patients in the intervention group ( P = .01 ) . No differences were found between groups in total ADEs or total health care utilization . CONCLUSIONS Pharmacist medication review , patient counseling , and telephone follow-up were associated with a lower rate of preventable ADEs 30 days after hospital discharge . Medication discrepancies before and after discharge were common targets of intervention OBJECTIVE To evaluate a training workshop for community pharmacy personnel to improve their counselling in smoking cessation based on the stage-of-change model . DESIGN A r and omised controlled trial of community pharmacies and pharmacy customers . SETTING All 76 non-city community pharmacies registered in Grampian , Scotl and , were invited to participate . Sixty-two pharmacies ( 82 % ) were recruited . SUBJECTS All the intervention pharmacy personnel were invited to attend the training ; 40 pharmacists and 54 assistants attended . A total of 492 customers who smoked ( 224 intervention , 268 controls ) were recruited during the 12-month recruitment period ( overall recruitment rate 63 % ) . MAIN OUTCOME MEASURES The perceptions of customers and pharmacy personnel of the pharmacy support and self-reported smoking cessation rates for the two groups of customers at one , four , and nine months . RESULTS The intervention customer respondents were significantly more likely to have discussed stopping smoking with pharmacy personnel , 85 % ( 113 ) compared with 62 % ( 99 ) of the controls ( p<0.001 ) . The former also rated their discussion more highly ; 34 % ( 45 ) of the intervention customers compared with 16 % ( 25 ) of the controls rated it as “ very useful ” ( p = 0.048 ) . Assuming non-responders had lapsed , one-month point prevalence of abstinence was cl aim ed by 30 % of intervention customers and 24 % of controls ( p = 0.12 ) ; four months ’ continuous abstinence was cl aim ed by 16 % of intervention customers and 11 % of controls ( p = 0.094 ) ; and nine months ’ continuous abstinence was cl aim ed by 12 % of intervention customers and 7 % of controls ( p = 0.089 ) . These trends in outcome were not affected by potential confounders ( sex , age , socioeconomic status , nicotine dependence , and type of nicotine replacement product used ) or adjustment for clustering . CONCLUSIONS The intervention was associated with increased and more highly rated counselling , and a trend toward higher smoking cessation rates , indicating that community pharmacy personnel have the potential to make a significant contribution to national smoking cessation targets OBJECTIVE To measure the effect of nurse practitioner and pharmacist consultations on the appropriate use of medications by patients . DESIGN We studied patients in the intervention arm of a r and omized controlled trial . The main trial intervention was provision of multidisciplinary team care and the main outcome was quality and processes of care for chronic disease management . SETTING Patients were recruited from a single publicly funded family health network practice of 8 family physicians and associated staff serving 10 000 patients in a rural area near Ottawa , Ont . PARTICIPANTS A total of 120 patients 50 years of age or older who were on the practice roster and who were considered by their family physicians to be at risk of experiencing adverse health outcomes . INTERVENTION A pharmacist and 1 of 3 nurse practitioners visited each patient at his or her home , conducted a comprehensive medication review , and developed a tailored plan to optimize medication use . The plan was developed in consultation with the patient and the patient 's doctor . We assessed medication appropriateness at the study baseline and again 12 to 18 months later . MAIN OUTCOME MEASURES We used the medication appropriateness index to assess medication use . We examined associations between personal characteristics and inappropriate use at baseline and with improvements in medication use at the follow-up assessment . We recorded all drug problems encountered during the trial . RESULTS At baseline , 27.2 % of medications were inappropriate in some way and 77.7 % of patients were receiving at least 1 medication that was inappropriate in some way . At the follow-up assessment s these percentages had dropped to 8.9 % and 38.6 % , respectively ( P < .001 ) . Patient characteristics that were associated with receiving inappropriate medication at baseline were being older than 80 years of age ( odds ratio [ OR ] = 5.00 , 95 % CI 1.19 to 20.50 ) , receiving more than 4 medications ( OR = 6.64 , 95 % CI 2.54 to 17.4 ) , and not having a university-level education ( OR = 4.55 , 95 % CI 1.69 to 12.50 ) . CONCLUSION We observed large improvements in the appropriate use of medications during this trial . This might provide a mechanism to explain some of the reductions in mortality and morbidity observed in other trials of counseling and advice provided by pharmacists and nurses . TRIAL REGISTRATION NUMBER NCT00238836 ( Clinical Trials.gov ) Abstract Objective To investigate the effects of compliance and periodic telephone counselling by a pharmacist on mortality in patients receiving polypharmacy . Design Two year r and omised controlled trial . Setting Hospital medical clinic . Participants 502 of 1011 patients receiving five or more drugs for chronic disease found to be non-compliant at the screening visit were invited for r and omisation to either the telephone counselling group ( n = 219 ) or control group ( n = 223 ) at enrolment 12 - 16 weeks later . Main outcome measures Primary outcome was all cause mortality in r and omised patients . Associations between compliance and mortality in the entire cohort of 1011 patients were also examined . Patients were defined as compliant with a drug if they took 80 - 120 % of the prescribed daily dose . To calculate a compliance score for the whole treatment regimen , the number of drugs that the patient was fully compliant with was divided by the total number of prescribed drugs and expressed as a percentage . Only patients who complied with all recommended drugs were considered compliant ( 100 % score ) . Results 60 of the 502 eligible patients defaulted and only 442 patients were r and omised . After two years , 31 ( 52 % ) of the defaulters had died , 38 ( 17 % ) of the control group had died , and 25 ( 11 % ) of the intervention group had died . After adjustment for confounders , telephone counselling was associated with a 41 % reduction in the risk of death ( relative risk 0.59 , 95 % confidence interval 0.35 to 0.97 ; P = 0.039 ) . The number needed to treat to prevent one death at two years was 16 . Other predictors included old age , living alone , rate of admission to hospital , compliance score , number of drugs for chronic disease , and non-treatment with lipid lowering drugs at screening visit . In the cohort of 1011 patients , the adjusted relative risk for death was 1.61 ( 1.05 to 2.48 ; P = 0.029 ) and 2.87 ( 1.80 to 2.57 ; P < 0.001 ) in patients with compliance scores of 34 - 66 % and 0 - 33 % , respectively , compared with those who had a compliance score of 67 % or more . Conclusion In patients receiving polypharmacy , poor compliance was associated with increased mortality . Periodic telephone counselling by a pharmacist improved compliance and reduced mortality . Trial registration International St and ard R and omised Controlled Trial Number Register : S RCT N48076318 BACKGROUND type 2 diabetes mellitus continues to increase in prevalence worldwide . Many factors have been cited as contributing to compliance , such as family and social support , education , number of tablets per dose , frequency of administration and health care provider communication . Toward these goals , the present study was developed to measure the effect offactors on glycemic control such as diabetes education by pharmacists , a diabetes disease booklet and special medication containers . MATERIAL AND METHOD A total of 360 volunteers with type 2 DM patients were recruited , participants were simple r and omized to control 180 and intervention 180 patients . Which intervention categorized to 4 groups ; all intervention groups received diabetes drug counseling by a pharmacist , one group received plus a diabetes booklet , one received plus special medical containers and the last group received all of them . The interventions were done at the 1st time of visit . Both the control and intervention groups were monitored for fasting plasma glucose and HbA1c at 0 , 3 , 6 months and glycemic level in both groups was compared . RESULTS After 3 months , mean fasting plasma glucose and HbA1c decreased wiih the intervention group vs. control group ( 152.36 + /- 39.73 to 131.52 + /- 35.22 mg% ) and ( 150.16 + /- 41.78 to 153.98 + /- 47.95 mg% ) respectively ; ( p < 0.001 ) . HbA1c level 8.16 + /- 1.44 to 7.72 + /- 1.26 vs 8.01 + /- 1.51 to 8.38 + /- 1.46 respectively ; ( p < 0.001 ) . After 6 months , mean fasting plasma glucose and HbA1c decreased with the intervention group vs. control group ( 152.36 + /- 39.73 to 145.20 + /- 46.07 mg% ) and ( 150.16 + /- 41.78 to 159.16 + /- 54.90 mg% ) respectively ; ( p < 0.013 ) . HbA1c level 8.16 + /- 1.44 to 7.91 + /- 1.27 vs. 8.01 + /- 1.51 to 8.80 + /- 1
Output:
| Conclusion Pharmacist counseling is an intervention directed to patients ’ health-related needs that improve inter-professional and inter-institutional communication , by collaborating to integrate health services . |
MS213537 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Objective : To assess the efficacy of an innovative smoking cessation intervention targeted to a multiethnic , economically disadvantaged HIV-positive population . Design : A two-group r and omized clinical trial compared a smoking cessation intervention delivered by cellular telephone with usual care approach . Methods : Current smokers from a large , inner city HIV/AIDS care center were recruited and r and omized to receive either usual care or a cellular telephone intervention . The usual care group received brief physician advice to quit smoking , targeted self-help written material s and nicotine replacement therapy . The cellular telephone intervention received eight counseling sessions delivered via cellular telephone in addition to the usual care components . Smoking-related outcomes were assessed at a 3-month follow-up . Results : The trial had 95 participants and 77 ( 81.0 % ) completed the 3-month follow-up assessment . Analyses indicated biochemically verified point prevalence smoking abstinence rates of 10.3 % for the usual care group and 36.8 % for the cellular telephone group ; participants who received the cellular telephone intervention were 3.6 times ( 95 % confidence interval , 1.3 - 9.9 ) more likely to quit smoking compared with participants who received usual care ( P = 0.0059 ) . Conclusions : These results suggest that individuals living with HIV/AIDS are receptive to , and can be helped by , smoking cessation treatment . In addition , smoking cessation treatment tailored to the special needs of individuals living with HIV/AIDS , such as counseling delivered by cellular telephone , can significantly increase smoking abstinence rates over that achieved by usual care Background Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones . This social cognitive theory-based intervention ( called “ STUB IT ” ) used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques . Objective The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation . Methods A r and omized controlled trial was conducted with 6-month follow-up . Participants had to be 16 years of age or over , be current daily smokers , be ready to quit , and have a video message-capable phone . Recruitment targeted younger adults predominantly through radio and online advertising . Registration and data collection were completed online , prompted by text messages . The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date , role model , and timing of messages . Extra messages were available on dem and to beat cravings and address lapses . The control group also set a quit date and received a general health video message sent to their phone every 2 weeks . Results The target sample size was not achieved due to difficulty recruiting young adult quitters . Of the 226 r and omized participants , 47 % ( 107/226 ) were female and 24 % ( 54/226 ) were Maori ( indigenous population of New Zeal and ) . Their mean age was 27 years ( SD 8.7 ) , and there was a high level of nicotine addiction . Continuous abstinence at 6 months was 26.4 % ( 29/110 ) in the intervention group and 27.6 % ( 32/116 ) in the control group ( P = .8 ) . Feedback from participants indicated that the support provided by the video role models was important and appreciated . Conclusions This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone . However , there was sufficient positive feedback about the ease of use of this novel intervention , and the support obtained by observing the role model video messages , to warrant further investigation . Trial registration Australian New Zeal and Clinical Trials Registry Number : ACTRN12606000476538 ; http://www.anzctr.org.au/trial_view.aspx?ID=81688 ( Archived by WebCite at http://www.webcitation.org/5umMU4sZi Summary We evaluated the effectiveness of a mobile phone text-messaging based smoking cessation intervention package among Chinese adolescent smokers . Students aged 16–19 years were recruited from six vocational high schools located in Shanghai . We assigned the six schools to an intervention group or a control group by cluster r and omization . The 92 participants in the intervention group were given tailored information via mobile phone text-messaging for 12 weeks . The 87 participants in the control group were provided with a self-help pamphlet about smoking cessation instead . After the intervention , attitudes towards the disadvantages of smoking were significantly improved , and the level of nicotine dependence and cigarette dependence significantly decreased in the intervention group . The intervention group had a relatively higher self-reported 7-day abstinence compared to the control group and 30-day abstinence , but the differences were not significant . However , the intervention group had a significantly higher rate of smoking reduction ( 66 % vs. 35 % ) and moving forward in quitting stages ( 52 % vs. 18 % ) compared to the control group . The interactive and tailored assistance provided by the mobile phone text-messaging was effective in smoking behaviour intervention in Chinese adolescent smokers Background We hypothesized that a fully automated mobile health ( mHealth ) intervention with tracking and texting components would increase physical activity . Methods and Results mActive enrolled smartphone users aged 18 to 69 years at an ambulatory cardiology center in Baltimore , Maryl and . We used sequential r and omization to evaluate the intervention 's 2 core components . After establishing baseline activity during a blinded run‐in ( week 1 ) , in phase I ( weeks 2 to 3 ) , we r and omized 2:1 to unblinded versus blinded tracking . Unblinding allowed continuous access to activity data through a smartphone interface . In phase II ( weeks 4 to 5 ) , we r and omized unblinded participants 1:1 to smart texts versus no texts . Smart texts provided smartphone‐delivered coaching 3 times/day aim ed at individual encouragement and fostering feedback loops by a fully automated , physician‐written , theory‐based algorithm using real‐time activity data and 16 personal factors with a 10 000 steps/day goal . Forty‐eight out patients ( 46 % women , 21 % nonwhite ) enrolled with a mean±SD age of 58±8 years , body mass index of 31±6 kg/m2 , and baseline activity of 9670±4350 steps/day . Daily activity data capture was 97.4 % . The phase I change in activity was nonsignificantly higher in unblinded participants versus blinded controls by 1024 daily steps ( 95 % confidence interval [ CI ] , −580 to 2628 ; P=0.21 ) . In phase II , participants receiving texts increased their daily steps over those not receiving texts by 2534 ( 95 % CI , 1318 to 3750 ; P<0.001 ) and over blinded controls by 3376 ( 95 % CI , 1951 to 4801 ; P<0.001 ) . Conclusions An automated tracking‐texting intervention increased physical activity with , but not without , the texting component . These results support new mHealth tracking technologies as facilitators in need of behavior change drivers . Clinical Trial Registration URL : http:// Clinical Trials.gov/. Unique identifier : NCT01917812 Background Worksite nutrition and physical activity interventions are important to help overweight and obese employees lose weight , but costs and insufficient sustained motivation prevent the majority of these programs from succeeding . Tailored text messaging in aiding weight management has been effective in several studies , but no studies have evaluated the effect of a tailored text message service on weight loss in a worksite health promotion program . Objective We studied the efficacy of a tailored text-messaging intervention for obese male participants in a worksite weight loss program of 6 months duration . Methods The study was an unblinded , r and omized controlled trial . Men with a body mass index greater than 25 kg/m2 were recruited from the Korea District Heating Corporation , the Korea Expressway Corporation , and the Korea Gas Corporation . The participants were identified by nurse managers . Participants were r and omly allocated to 1 of the following 2 groups for 24 weeks : ( 1 ) intervention group , which received tailored text message reminders every other day plus 4 offline education sessions and brief counseling with monthly weight check by nurses for weight control over 6 months and ( 2 ) control group , which received the 4 offline education sessions and brief counseling with monthly weight check by nurses about weight control over 6 months . The primary outcome was the difference in weight loss at 6 months . A mixed-model repeated- measures analysis was performed to evaluate the effect of the intervention group ’s weight loss compared with the control group . Results A total of 205 obese men were r and omized into either the intervention ( n=104 ) or the control group ( n=101 ) . At the end of 6 months , the intervention group ( n=63 ) had lost 1.71 kg ( 95 % CI –2.53 to –0.88 ) and the control group ( n=59 ) had lost 1.56 kg ( 95 % CI –2.45 to –0.66 ) ; the difference between the 2 groups was not significant ( mean difference –0.15 , 95 % CI –1.36 to 1.07 ) . At the end of the study , 60 % ( 34/57 ) of the intervention group rated the message program as helpful for weight control and 46 % ( 26/57 ) would recommend the text message service to their friends . Conclusions Tailored text message reminders did not have a significant effect on weight loss in obese men as part of a worksite weight loss program . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 39629189 ; http://www.is rct n.com/IS RCT N39629189?q=39629189&filters=&sort=&offset=1&total Results = 1&page=1&pageSize=10 & search Type = basic- search ( Archived by WebCite at http://www.webcitation.org/6VsFkwJH6 ) Aim To determine the effectiveness and cost-effectiveness of a mobile phone intervention to improve exercise capacity and physical activity behaviour in people with ischaemic heart disease ( IHD ) . Methods and results In this single-blind , parallel , two-arm , r and omized controlled trial adults ( n = 171 ) with IHD were r and omized to receive a mobile phone delivered intervention ( HEART ; n = 85 ) plus usual care , or usual care alone ( n = 86 ) . Adult participants aged 18 years or more , with a diagnosis of IHD , were clinical ly stable as out patients , able to perform exercise , able to underst and and write English , and had access to the Internet . The HEART ( Heart Exercise And Remote Technologies ) intervention involved a personalized , automated package of text messages and a secure website with video messages aim ed at increasing exercise behaviour , delivered over 24 weeks . All participants were able to access usual community-based cardiac rehabilitation , which involves encouragement of physical activity and an offer to join a local cardiac support club . All outcomes were assessed at baseline and 24 weeks and included peak oxygen uptake ( PVO2 ; primary outcome ) , self-reported physical activity , health-related quality of life , self-efficacy and motivation ( secondary outcomes ) . Results showed no differences in PVO2 between the two groups ( difference −0.21 ml kg−1 min−1 , 95 % CI : −1.1 , 0.7 ; p = 0.65 ) at 24 weeks . However significant treatment effects were observed for selected secondary outcomes , including leisure time physical activity ( difference 110.2 min/week , 95 % CI : −0.8 , 221.3 ; p = 0.05 ) and walking ( difference 151.4 min/week , 95 % CI : 27.6 , 275.2 ; p = 0.02 ) . There were also significant improvements in self-efficacy to be active ( difference 6.2 % , 95 % CI : 0.2 , 12.2 ; p = 0.04 ) and the general health domain of the SF36 ( difference 2.1 , 95 % CI : 0.1 , 4.1 ; p = 0.03 ) at 24 weeks . The HEART programme was considered likely to be cost-effective for leisure time activity and walking . Conclusions A mobile phone intervention was not effective at increasing exercise capacity over and above usual care . The intervention was effective and probably cost-effective for increasing physical activity and may have the potential to augment existing cardiac rehabilitation services Background Despite promising data in Western countries , there is a dearth of research into the efficacy of text messaging-based smoking cessation programs in other setting s , including the Middle East , where smoking prevalence rates are higher . Objective This paper reports cessation rates observed in SMS Turkey , a text messaging-based smoking cessation program for adult smokers in Ankara , Turkey . Methods This study was a small-scale , parallel-group r and omized controlled trial ( RCT ) conducted in Ankara , Turkey . Participants were adult daily smokers who were seriously thinking about quitting in the next 15 days and living in Ankara , Turkey . The text messaging intervention , SMS Turkey , provided 6 weeks of daily messages aim ed at giving participants skills to help them quit smoking . Messages were sent in an automated fashion , except 2 days and 7 days after the initial quit day . On days 2 and 7 , the research assistant manually assigned participants to content “ paths ” based on whether they were still not smoking or had relapsed . The
Output:
| There was no difference in peak oxygen intake at 3 months in a trial of an SMS-based PA intervention .
Smoking cessation support delivered by SMS increases quitting rates .
Trials of PA interventions reporting outcomes ≥3 months showed no benefits .
There were at best modest benefits of diet and PA interventions . |
MS213538 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: OBJECTIVE --To assess the effectiveness of angiotensin converting enzyme inhibition in preventing the development of diabetic nephropathy ( albuminuria greater than 300 mg/24h ) . DESIGN --Open r and omised controlled study of four years ' duration . SETTING --Outpatient diabetic clinic in tertiary referral centre . PATIENTS --44 normotensive ( mean blood pressure 127/78 ( SD 12/10 ) mm Hg ) insulin dependent diabetic patients with persistent microalbuminuria ( 30 - 300 mg/24h ) . INTERVENTIONS --The treatment group ( n = 21 ) was initially given captopril ( 25 mg/24 h ) . The dose was increased to 100 mg/24 h during the first 16 months and thiazide was added after 30 months . The remaining 23 patients were left untreated . MAIN OUTCOME MEASURES --Albuminuria , kidney function , development of diabetic nephropathy ( albuminuria greater than 300 mg/24 h ) , and arterial blood pressure . RESULTS -- Clinical and laboratory variables were comparable at baseline . Urinary excretion of albumin was gradually reduced from 82 ( 66 - 106 ) to 57 ( 39 - 85 ) mg/24 h ( geometric mean ( 95 % confidence interval ) ) in the captopril treated group , whereas an increase from 105(77 - 153 ) to 166 ( 83 - 323 ) mg/24 h occurred in the control group ( p less than 0.05 ) . Seven of the untreated patients progressed to diabetic nephropathy , whereas none of the captopril treated patients developed clinical overt diabetic nephropathy ( p less than 0.05 ) . Systemic blood pressure , glomerular filtration rate , haemoglobin A1c concentration , and urinary excretion of sodium and urea remained practically unchanged in the two groups . CONCLUSIONS --The findings suggest that angiotensin converting enzyme inhibition postpones the development of clinical overt diabetic nephropathy in normotensive insulin dependent diabetic patients with persistent microalbuminuria Recent studies utilizing converting enzyme inhibitors ( CEI ) in diabetic rats document reductions in both renal hypertrophy and albuminuria . Four separate clinical studies in normotensive patients with diabetes demonstrate reduction of microalbuminuria with CEIs independent of blood pressure reduction . The present pilot study examines the results of reducing an elevated glomerular filtration rate on changes in renal size and microalbuminuria in normotensive , hyperfiltering insulin-dependent diabetic ( IDDM ) patients . Fifteen IDDM patients were r and omized to either placebo or the CEI , lisinopril . Dosage of lisinopril was titrated over 3 months to reduce glomerular filtration rate ( GFR ) to < or = 2.33 mL/sec . Evaluation at 18 months demonstrated the lisinopril group had a marked reduction in renal size ( 16.9 + /- 1.1 , baseline versus 12.8 + /- 0.9 cm , 18 months ; p < 0.05 ) and microalbuminuria ( 92 + /- 11 micrograms/min , baseline versus 23 + /- 26 micrograms/min , 18 months ; p < 0.05 ) . No change in renal size was noted in the placebo group ( 15.4 + /- 0.8 , baseline versus 14.9 + /- 0.7 cm , 18 months ; NS ) and albuminuria increased ( 118 + /- 15 micrograms/min , baseline versus 293 + /- 32 micrograms/min , 18 months ; p < 0.05 ) . Mean arterial pressure at 18 months was significantly lower in the lisinopril group compared to placebo ( 102 + /- 4 , placebo versus 87 + /- 6 mm Hg , CEI , p < 0.05 ) . This study supports previous animal studies that document reductions in both microalbuminuria and renal size by a CEI . The overall impact of these findings on preservation of renal function can not be assessed , however , in this short-term study STUDY OBJECTIVE --To assess the effectiveness of inhibition of angiotensin converting enzyme in preventing diabetic nephropathy . DESIGN --R and omised follow up study of normotensive diabetics with persistent microalbuminuria ( 30 - 300 mg/24 hours ) treated with enalapril or its matched placebo for one year . Double blind for first six months , single blind for last six months . SETTING --Diabetic clinic in tertiary referral centre . PATIENTS --Treatment group and placebo group each comprised 10 normotensive diabetics with persistent microalbuminuria . INTERVENTIONS --Treatment group was given enalapril 20 mg daily and controls matched placebo . Patients were given antihypertensive treatment after one year . END POINT -- Albumin excretion , arterial pressure , and renal function . MAIN RESULTS --In last three months of trial three of 10 patients taking placebo had diabetic nephropathy ( albumin excretion greater than 300 mg/24 hours ) . No patients taking enalapril developed nephropathy and five showed normal albumin excretion ( less than 30 mg/24 hours ) ( p = 0.005 , Mann-Whitney test ) . Mean arterial pressure was reduced by enalapril throughout study ( p less than 0.005 ) but increased linearly with placebo ( p less than 0.05 ) . Albumin excretion decreased linearly with enalapril but not placebo . An increase in albumin excretion with placebo was positively related to the increase in mean arterial pressure ( r = 0.709 , p less than 0.05 , Spearman 's rank test ) . With enalapril total renal resistances and fractional albumin clearances improved progressively ( time effect , p = 0.0001 ) . CONCLUSION --Inhibition of angiotensin converting enzyme prevents development of nephropathy in normotensive diabetics with persistent microalbuminuria . This may be due to reduction in intraglomerular pressure and to prevention of increased systemic blood pressure . Future studies should compare long term effects of inhibitors of converting enzyme with other antihypertensive drugs The effect of early aggressive antihypertensive treatment on kidney function in diabetic nephropathy was studied prospect ively in ten insulin-dependent diabetics ( mean age 29 years ) . During the mean pretreatment period of 29 ( range 23 - 38 ) months the glomerular filtration rate ( GFR ) decreased significantly and the urinary albumin excretion rate and arterial blood pressure rose significantly . During the 39 month ( range 28 - 48 ) period of antihypertensive treatment with metoprolol , hydralazine , and frusemide ( furosemide ) or thiazide , arterial blood pressure fell from 144/97 mm Hg ( mean of all pretreatment values ) to 128/84 mm Hg ( mean of all post-treatment values ) , urinary albumin excretion from 977 micrograms/min to 433 micrograms/min , and GFR from 80 to 62 ml/min/1 . 73 m2 . The rate of decline in GFR decreased from 0.91 ml/min/month before treatment to 0.39 ml/min/month ( range 0.08 to 0.68 ml/min/month ) during treatment The beneficial effect of long-term treatment with an angiotensin-converting enzyme ( ACE ) inhibitor on urinary microalbumin excretion ( UAE ) and renal function was investigated in a 4 year , r and omized prospect i ve study in normotensive patients with non-insulin-dependent ( Type 2 ) diabetes mellitus . Sixty-two normotensive patients with Type 2 diabetes mellitus and microalbuminuria but normal renal function were r and omized to receive either enalapril 5 mg day-1 or no treatment . In the enalapril-treated patients , UAE was reduced from 115.4 + /- 80.1 to 95.6 + /- 61.7 mg 24 h-1 after 12 months ( p < 0.05 ) and to 75.3 + /- 44.8 mg 24 h-1 after 48 months ( p < 0.001 ) . In the untreated group , UAE increased slowly from 93.9 + /- 69.9 to 150.0 + /- 144.5 mg 24 h-1 after 48 months . No changes in creatinine clearance , blood pressure or HbA1C were seen in either group during the 4-year period . In normotensive Type 2 diabetic patients with early stage of diabetic microalbuminuria . This effect is long-lasting and probably independent of the antihypertensive action of the drug BACKGROUND Diabetic nephropathy is the leading cause of end-stage renal disease in developed countries . Duration of diabetes , blood pressure values , and metabolic status are the major determinants of the course of nephropathy , and microalbuminuria is the hallmark of its onset . Angiotensin-converting enzyme inhibitors offer important renoprotection to hypertensive and normotensive patients with insulin-dependent diabetes mellitus and non-insulin-dependent diabetes mellitus . Our study extends previous observations for duration and the effect of angiotensin-converting enzyme inhibition on advanced nephropathy . METHODS Double-blinded ( first phase ) and open ( second phase ) r and omized controlled study of 7 years . Ninety-four normotensive patients with non-insulin-dependent diabetes mellitus whose serum creatinine levels were lower than 123.76 mumol/L ( 1.4 mg/dL ) and who had microalbuminuria ( 30 to 300 mg/24 h ) were given enalapril maleate , 10 mg/d , or placebo , for 5 years . For 2 more years they were followed up openly and given the choice to receive enalapril or no treatment . RESULTS In the enalapril-treated patients , albuminuria remained stable for 7 years . An increase from ( mean + /- SD ) 123 + /- 58 to 310 + /- 167 mg/24 h occurred in the untreated group after 5 years , and a further increase to ( mean + /- SD ) 393 + /- 223 mg/24 h occurred after 7 years . Reciprocal creatinine was unchanged in treated patients for 7 years ; in the untreated patients , the mean decline was 13 % at 5 years and 16 % at 7 years . Treatment with enalapril result ed in an absolute risk reduction of 42 % for nephropathy to develop during 7 years ( 95 % confidence interval , 15 % to 69 % ; P < .001 , Student 's t test ) . Glycosylated hemoglobin and body mass index remained unchanged . CONCLUSIONS Angiotensin-converting enzyme inhibition offers long-term protection against the development of nephropathy in normotensive patients with noninsulin-dependent diabetes mellitus who have microalbuminuria , and it stabilizes renal function in previously untreated patients with impaired renal function . Discontinuation of treatment results in renewed progression of nephropathy OBJECTIVE --To compare the effects of sodium depletion and of angiotensin I converting enzyme inhibition on microalbuminuria in insulin dependent diabetes . DESIGN --R and omised , double blind , double dummy parallel study of normotensive diabetic patients with persistent microalbuminuria ( 30 - 300 mg/24 h ) treated with enalapril or hydrochlorothiazide for one year after a three month , single blind placebo period . SETTING --Diabetic clinic in a tertiary referral centre . PATIENTS --10 diabetic patients with low microalbuminuria ( 30 - 99 mg/24 h ) and 11 with high microalbuminuria ( 100 - 300 mg/24 h ) . INTERVENTIONS --11 subjects ( six with low microalbuminuria , five with high microalbuminuria ) were given enalapril 20 mg plus placebo hydrochlorothiazide once daily and 10 ( four with low microalbuminuria , six with high microalbuminuria ) hydrochlorothiazide 25 mg plus placebo enalapril once daily . MAIN OUTCOME MEASURES --Monthly assessment of urinary albumin excretion and mean arterial pressure ; plasma active renin and aldosterone concentrations and renal function studies at 0 , 6 , and 12 months . RESULTS --Median urinary albumin excretion decreased from 59 ( range 37 - 260 ) to 38 ( 14 - 146 ) mg/24 h with enalapril and from 111 ( 33 - 282 ) to 109 ( 33 - 262 ) mg/24 h with hydrochlorothiazide ( analysis of variance , p = 0.0436 ) . During the last three months
Output:
| Treatment provided a significant reduction in albumin excretion rate in both insulin dependent diabetes mellitus and non insulin dependent diabetes mellitus .
Treatment with either captopril , enalapril or lisinopril reduced albumin excretion rate in comparison with control patients .
A significantly greater lowering of blood pressure was experienced by initially normotensive patients in the angiotensin converting enzyme inhibitor than in the placebo group .
Average glycosylated haemoglobin fell a little in the treated patients and rose in the controls , the difference being just significant .
The difference in changes in glomerular filtration rate did not reach statistical significance .
REVIEW ER 'S CONCLUSIONS Inhibition of angiotensin converting enzyme can arrest or reduce the albumin excretion rate in microalbuminuric normotensive diabetics , as well as reduce or prevent an increase in blood pressure .
But , given the drop in blood pressure in patients on angiotensin converting enzyme inhibitors , it is not certain that the reduction of albumin excretion rate is due to a separate renal effect .
A direct link with postponement of end-stage renal failure has not been demonstrated .
There appear to be no substantial side effects |
MS213539 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: To investigate the role of plasma calcitonin gene-related peptide ( CGRP ) in paediatric migraine , we prospect ively collected 134 blood sample s during or between attacks from 66 migraine , 33 non-migraine headache ( non-migraine ) and 22 non-headache patients , aged 4–18 years . Plasma CGRP concentrations were measured by enzyme-linked immunosorbent assay and disability by Pediatric MIgraine Disability ASsessment ( PedMIDAS ) question naire . Migraineurs had higher plasma CGRP levels than non-migraine patients ( P = 0.007 ) . The attack level was higher than the non-attack level in migraine ( P = 0.036 ) , but not in non-migraine , patients . This was also revealed in paired comparison ( n = 9 , P = 0.015 vs. n = 4 , P = 0.47 ) . Using a threshold of 55.1 pg/ml , the sensitivity of the attack level in predicting migraine was 0.81 , and specificity 0.75 . The PedMIDAS score tended to be higher in the high CGRP ( > 200 pg/ml , n = 7 ) group than in the low ( < 200 pg/ml , n = 33 ) group ( 26.07 vs. 19.32 , P = 0.16 ) using Mann – Whitney test . Plasma CGRP is useful for diagnosis in paediatric migraine Interictal serum levels of serotonin and plasma and mononuclear cell concentrations of β‐endorphin were measured in 20 juvenile patients ( 13 suffering from migraine without aura and 7 from episodic tension‐type headache ) before and after 3 months of L‐5‐hydroxytryptophan treatment ( 5 mg/ kg/day ) and compared with a control group of 17 headache‐free healthy subjects Plasma levels of beta‐endorphin ( BE ) , an endogenous opioid analgesic , are often reported as they relate to acute and chronic pain outcomes . However , little is known about what resting plasma BE levels might reveal about functioning of the endogenous opioid antinociceptive system . This study directly examined associations between resting plasma BE and subsequent endogenous opioid analgesic responses to acute pain in 39 healthy controls and 37 individuals with chronic low back pain ( LBP ) . Resting baseline levels of plasma BE were assessed . Next , participants received opioid blockade ( 8 mg naloxone i.v . ) or placebo in a double‐blind , r and omized , crossover design . Participants then underwent two acute pain stimuli : finger pressure ( FP ) pain and ischaemic ( ISC ) forearm pain . Blockade effects ( naloxone minus placebo pain ratings ) were derived to index endogenous opioid analgesic function . In placebo condition analyses for both pain stimuli , higher resting BE levels were associated with subsequently greater reported pain intensity ( p 's < 0.05 ) , with this effect occurring primarily in healthy controls ( BE × Participant Type interactions , p 's < 0.05 ) . In blockade effect analyses across both pain tasks , higher resting plasma BE predicted less subsequent endogenous opioid analgesia ( smaller blockade effects ; p 's < 0.05 ) . For the ISC task , these links were significantly more prominent in LBP participants ( BE × Participant Type Interactions , p 's < 0.05 ) . Results suggest that elevated resting plasma BE may be a potential biomarker for reduced endogenous opioid analgesic capacity , particularly among individuals with chronic pain . Potential clinical implication s are discussed & NA ; Although calcitonin gene‐related peptide ( CGRP ) has been shown to be elevated in jugular venous blood of adult migraineurs during acute migraine attacks , it remains unknown whether CGRP is increased outside of attacks in jugular or cubital venous blood . The aim of the present study was to compare interictal plasma levels of CGRP in adult migraine patients and in healthy controls . Twenty patients with a diagnosis of migraine with or without aura and 20 healthy controls were included . In blood from the cubital vein , CGRP levels were significantly higher in patients ( 75±8 pmol/l ( mean±SEM ) ) than in controls ( 49±3 pmol/l ) ( P=0.005 ) . The subgroup of patients suffering exclusively from migraine without aura ( n=14 ) also had significantly higher levels of CGRP ( 82±10 pmol/l ) than controls ( n=20 ; 49±3 pmol/l ) ( P=0.001 ) . The findings could not be explained by confounding factors such as age , sex or use of contraceptive pills . We therefore conclude that CGRP is increased in cubital venous blood of migraineurs outside of attack . It is hypothesized that this finding may reflect a long‐lasting or permanent abnormal neurogenic vascular control in patients with migraine The aim of the present study was to verify cerebrospinal fluid ( CSF ) levels of glial cell line-derived neurotrophic factor ( GDNF ) and somatostatin , both measured by sensitive immunoassay , in : 16 chronic migraine ( CM ) patients , 15 patients with an antecedent history of migraine without aura diagnosed as having probable chronic migraine ( PCM ) and probable analgesic-abuse headache ( PAAH ) , 20 patients affected by primary fibromyalgia syndrome ( PFMS ) , and 20 control subjects . Significantly lower levels of GDNF and somatostatin were found in the CSF of both CM and PCM + PAAH patients compared with controls ( GDNF = P < 0.001 , P < 0.002 ; somatostatin = P < 0.002 , P < 0.0003 ) , without significant difference between the two groups . PFMS patients , with and without analgesic abuse , also had significantly lower levels of both somatostatin and GDNF ( P < 0.0002 , P < 0.001 ) , which did not differ from those of CM and PCM + PAAH patients . A significant positive correlation emerged between CSF values of GDNF and those of somatostatin in CM ( r = 0.70 , P < 0.02 ) , PCM + PAAH ( r = 0.78 , P < 0.004 ) , and PFMS patients ( r = 0.68 , P < 0.008 ) . Based on experimental findings , it can be postulated that reduced CSF levels of GDNF and somatostatin in both CM and PCM + PAAH patients can contribute to sustained central sensitization underlying chronic head pain . The abuse of simple or combination analgesics does not seem to influence the biochemical changes investigated , which appear to be more strictly related to the chronic pain state , as demonstrated also for fibromyalgia & NA ; In nine women suffering from menstrual migraine ( MM ) , and in six healthy asymptomatic volunteers , plasma beta‐endorphin ( beta‐EP ) , growth hormone ( GH ) , norepinephrine ( NE ) , and 3‐methoxy‐4‐hydroxyphenylethyleneglycol ( MHPG ) concentrations were measured in response to clonidine ( 0.075 mg , i.v . ) stimulation . In MM patients clonidine testing was performed in both the early and the late luteal phases of the menstrual cycle . Premenstrual symptoms were prospect ively evaluated in the actual cycle using the Moos Menstrual Distress Question naire . beta‐EP ( after gel chromatography ) and GH were measured using radioimmunoassay . NE and MHPG were evaluated by HPLC using electrochemical detection . In both phases of the menstrual cycle clonidine significantly reduced NE and MHPG levels in MM patients and controls in a similar way . In MM patients beta‐EP and GH plasma levels were stimulated by clonidine only in the early luteal phase , whereas they remained unchanged when they were stimulated in the premenstrual period . In controls the response of both hormones was not affected by the menstrual cycle . The lack of hormonal response to clonidine in MM may suggest a postsynaptic alpha 2‐adrenoreceptor hyposensitivity during the premenstrual period . This demonstrates a transient vulnerability of the neuroendocrine/neurovegetative systems , and could thus be a factor facilitating the precipitation of both behavioral changes and migraine attacks BACKGROUND Pharmaceuticals with calcium- or sodium-channel-blocking activity have proven useful for migraine prophylaxis , and calcium channel , sodium transporter , and sodium channel gene mutations have been found in familial hemiplegic migraine . However , it is not known whether calcium or sodium homeostasis is altered in migraine . OBJECTIVE To compare levels of sodium , calcium , potassium , and magnesium in cerebrospinal fluid ( CSF ) and blood plasma between migraineurs and controls . METHODS We recruited 20 migraineurs without aura and 11 controls prospect ively , and studied migraineurs in sick ( MH(+ ) ) and well ( MH(- ) ) states . We collected lumbar CSF and venous blood plasma , quantified elements with ion-selective electrodes or colorimetry , and determined osmolality by depression of freezing point . We compared levels of Na(+ ) , Ca(2 + ) , K(+ ) , and Mg among and also within subjects who were studied in both MH(+ ) and MH(- ) states . RESULTS Mean CSF Na(+ ) levels were increased by 3 mmol/L in MH(+ ) compared with MH(- ) and by 4 mmol/L compared to controls ( P < 0.005 ) . In 4 subjects who were sample d in both MH(+ ) and MH(- ) states , mean CSF Na(+ ) concentration increased by 2 mmol/L in the MH(+ ) state compared with the MH(- ) state ( P < 0.05 ) . Simultaneous plasma Na(+ ) levels did not differ among the 3 clinical groups , nor did osmolality , total Ca and Ca(2 + ) , K(+ ) , and total Mg levels in CSF . CONCLUSIONS Compared to both controls and the MH(- ) state , CSF Na(+ ) concentration increased in MH(+ ) independently from other clinical or pharmacological fluctuations , CSF concentrations of Ca(2 + ) , Mg , and K(+ ) , and blood plasma Na(+ ) levels . These results implicate a deviation of Na(+ ) homeostasis in migraine . The modestly elevated extracellular Na(+ ) in MH(+ ) may cause the neural changes that underlie clinical features of migraine Neurotrophins , such as brain-derived neurotrophic factor ( BDNF ) and nerve growth factor ( NGF ) , have been implicated in the generation and modulation of pain . To investigate whether alterations in neurotrophin levels can be detected in subjects suffering from nociceptive disorders , such as primary headaches , we determined the peripheral ( platelet and plasma ) levels of BDNF and NGF in patients suffering from migraine , with or without aura , or cluster headache ( CH ) , in the interictal phase , and in healthy volunteers . All primary headaches patients studied showed significantly decreased platelet levels of BDNF ( migraine vs. controls P < 0.001 ; CH vs. controls P < 0.01 ) , while a selective reduction of platelet NGF was observed in migraine sufferers and not in CH patients compared with control subjects ( migraine vs. controls P < 0.001 ) . These changes were not accompanied by significant modifications of neurotrophin plasma levels . Our findings show for the first time that changes in peripheral levels of neurotrophines ( BDNF and NGF ) occur in patients suffering from different types of primary headaches , suggesting a potential involvement of BDNF and NGF in the pathophysiology of these disorders , and raising the possibility that differences in peripheral neurotrophins may help to distinguish migraine biologically from CH
Output:
| Conclusions Glutamate , β-EP , CGRP and NGF concentrations are altered in CSF and , except for NGF , also in blood of migraineurs . |
MS213540 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Animal data suggest that a D1 antagonistic component in neuroleptic drugs counteracts development of dopamine supersensitivity and of tolerance to cataleptic effect . This has led to the hypothesis that neuroleptics with D1 antagonistic activity should cause a better suppression of tardive dyskinesia ( TD ) and less rebound aggravation after withdrawal than pure D2 antagonists . In this study the effect of zuclopenthixol ( mixed D1/D2 antagonist ) and haloperidol ( D2 antagonist ) was evaluated in chronic psychotic patients with TD . Fifteen patients completed a r and omized crossover study with blind evaluation of TD and parkinsonism . The test medications , haloperidol and zuclopenthixol , caused a significant suppression of TD and a significant increase of parkinsonism . No significant differences between haloperidol and zuclopenthixol were observed . No TD aggravation was seen . The lack of differences between the mixed D1/D2 antagonist and a D2 antagonist suggest that tolerance and DA supersensitivity play no or a minor role for development of TD Zuclopenthixol acetate — a new injectable formulation with a duration of action of 2–3 days — was compared with conventional intramuscular and oral formulations of haloperidol and zuclopenthixol in the initial treatment of acutely disturbed , psychotic patients . The patients were stratified into 3 diagnostic categories : acute psychoses ( 48 patients ) , mania ( 22 patients ) , and exacerbation of chronic psychoses ( 73 patients ) . The patients were rated on the Brief Psychiatric Rating Scale ( BPRS ) , the Bech‐Rafaelsen Mania Rating Scale ( brmas ) ( only manic patients ) and globally on the Clinical Global Impression ( CGI ) . The study was an open , r and omized multicentre trial with a 6‐day treatment period . The zuclopenthixol acetate patients received 1–4 doses , the haloperidol patients 1–26 and the zuclopenthixol patients 1–22 doses . The assessment s on the CGI showed that all 3 treatments caused a clear reduction of the severity of illness scores in all 3 diagnostic categories , with no differences between treatments . The ratings of the acute and chronic psychotic patients on the BPRS also showed significant reductions in scores with no differences between treatments . All 3 treatments caused a rapid remission of symptoms on the BRMAS . Haloperidol induced hypokinesia in significantly more patients than zuclopenthixol acetate after 24 h. Later there were no significant differences between treatments . Zuclopenthixol acetate fulfils many desires for an amended neuroleptic formulation for the initial treatment of acutely disturbed psychotic patients OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas In an open clinical multi-centre trial carried out in five Danish psychiatric departments , patients suffering from acute psychosis including mania or exacerbation of chronic psychosis were given injections of 5 % zuclopenthixol acetate in ' Viscoleo ' . The object of the trial was to evaluate the treatment by means of a global assessment of the severity of the psychosis , the therapeutic effect and the side-effects . The results showed that the treatment was rapidly effective in reducing the severity of psychotic symptoms combined with an advantageous unspecific sedation . The side-effect profile was similar to that after other neuroleptics . Special attention should be paid , however , to a possible occurrence of acute dystonia which was observed particularly in young men with acute psychosis The aim of this study was to evaluate the efficacy and side effects of zuclopenthixol acetate compared with haloperidol in the management of the acutely disturbed schizophrenic patient . Suitable subjects diagnosed as having schizophreniform disorder or acute exacerbation of schizophrenia admitted to the psychiatric wards Hospital Kuala Lumpur were r and omised to receive either zuclopenthixol acetate or haloperidol . They were rated blind for three consecutive days using the Brief Psychiatric Rating Scale ( BPRS ) , Clinical Global Impression ( CGI ) and UKU Side Effects Scale . Apart from repeat injections of the same medication , no other anti-psychotic was given for the duration of the study . 50 subjects entered the study of which 44 completed . 23 were given zuclopenthixol acetate and 21 haloperidol . Both groups significantly reduced BPRS and CGI scores on all 3 days compared to the initial rating ( p < 0.001 ) . There was however no difference between the zuclopenthixol acetate and haloperidol group scores on all days ( p > 0.05 ) . More subjects on haloperidol than zuclopenthixol required more than 1 injection during the study . Both groups had minimal side effects . Zuclopenthixol acetate was effective in the management of the acutely disturbed schizophrenic BACKGROUND Case series and review s have suggested the effectiveness of zuclopenthixol acetate in the acute management of disturbed behaviour caused by serious mental illnesses . This review investigates the trial-based evidence for these suggestions . METHODS All r and omized clinical trials comparing zuclopenthixol acetate to other ' st and ard ' treatments for the acute management of those with serious mental illnesses were identified and , if possible , their results summated . RESULTS Six trials were identified . All had method ological problems and one did not meet the minimal method ological inclusion criteria . The summary data do not demonstrate that zuclopenthixol acetate is better than ' st and ard care ' for altering behaviour , decreasing the need for supplementary medication , avoiding side-effects , or postponing early discharge against medical advice . One trial , however , presented data that suggested an earlier , more intense level of sedation . CONCLUSIONS Recommendations of review s and open studies for the use of zuclopenthixol acetate in preference to ' st and ard ' treatments in the psychiatric emergency are not supported by evidence from r and omized controlled trials One hundred mentally retarded patients from five Finnish institutions took part in a double‐blind , double‐dummy 12‐week trial assessing the therapeutic effect of cis(Z)‐clopenthixol and haloperidol . Assessment s including CGI by psychiatrists and ward personnel as well as a 4‐item target symptom scale were done at weeks 0 , 4 , 8 , and 12 . Improvement was registered by the psychiatrists in 16 , 21 , and 24 cis(Z)‐clopenthixol patients and in 11 , 6 , and 7 haloperidol patients at weeks 4 , 8 , and 12 , respectively ‐ the difference between the two drugs being significant at weeks 8 and 12 . The ratings of CGI by the personnel and the 4‐item scale by the psychiatrists showed less improvements and no significant differences between the two drugs . While the overall impression of interference of patients ’ functioning by side‐effects were in the favour of haloperidol the number of single side effects increased more with haloperidol than with cis(Z)‐clopenthixol during the 12 weeks . Average doses administered at week 12 were 34 mg cis(Z)‐clopenthixol and 5 mg haloperidol Fifty-four hospitalized chronic schizophrenics were included in a double-blind controlled trial to assess the value of clopenthixol in treating [ See Table 4 in Source Pdf . ] such cases and compare its effects with those of chlorpromazine . Two rating scales were used to assess the patients clinical ly : a behavioural scale with items fairly objective and concrete , and an inferential one with items more " speculative " or " interpretative " . The patients were rated without medication and four weeks later with medication . Clopenthixol result ed in a change at the behavioural level . Chlorpromazine result ed in changes at the behavioural and inferential levels . No changes occurred with the placebo . Side-effects were not severe at therapeutically effective levels A double‐blind , r and omized , multi‐center , parallel‐group study was conducted in Finl and to compare the efficacy and safety of risperidone with zuclopenthixol in patients with acute exacerbations of schizophrenia or schizophreniform disorder . Ninety‐eight patients were r and omly assigned to treatment with risperidone ( n= 48 ) or zuclopenthixol ( n= 50 ) , in variable doses , for 6 weeks . The mean daily doses of risperidone and zuclopenthixol at the end of the trial were 8 mg and 38 mg respectively . Efficacy was assessed throughout by the Positive and Negative Syndrome Scale for schizophrenia and Clinical Global Impression . Safety assessment s included the Extrapyramidal Symptom Rating Scale , UKU Side‐Effect Rating Scale , vital signs , body weight and laboratory screening . The results indicate that risperidone is at least as effective as zuclopenthixol for the treatment of acute schizophrenic episodes , with a trend towards greater improvement in the overall severity of symptoms . The onset of action was significantly shorter with risperidone than with zuclopenthixol . Although the general tolerability of the two drugs was comparable , fewer patients experienced extrapyramidal symptoms with risperidone , so that significantly fewer risperidone‐treated patients required antiparkinsonian medication Sixty‐three chronic schizophrenic in‐ patients were included in the double‐blind , double‐dummy clinical trial comparing antipsychotic activity and side effects of cis(Z)‐clopenthixol and haloperidol . Test treatment was administered at least 8 and in most cases 12 weeks with clinical evaluations including BPRS , NOSIE‐30 , CGI and single side effects done at weeks 0 , 2 , 4 , 8 , and 12 . The average end‐of‐trial doses were 40 mg cis(Z)‐clopenthixol and 10 mg haloperidol . Statistically significant improvements of total BPRS‐score and Thinking disturbance were registered with both drugs from week 2 onwards . At week 12 when 36 patients were receiving test treatment total BPRS‐score was reduced by 31 % in the cis(Z)‐clopenthixol group and by 17 % in the haloperidol group . At week 4 Thinking disturbance was reduced by 32 % in the cis(Z)‐clopenthixol group and by 16 % in the haloperidol group ‐ these findings constituted the only significant difference between test drugs . Compared to the BPRS‐ results less improvements and no differences between test drugs were registered with NOSIE‐30 and CGI . Any trends towards different frequency and severity of side effects were in the favour of cis(Z)‐clopenthixol BACKGROUND We compared the efficacy of two neurole
Output:
| This review did not find any suggestion that zuclopenthixol acetate is more or less effective in controlling aggressive acute psychosis , or in preventing adverse effects than intramuscular haloperidol , and neither seemed to have a rapid onset of action . |
MS213541 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Purpose Pasireotide ( SOM230 ) , a novel multireceptor lig and somatostatin analog ( SSA ) , binds with high affinity to four of the five somatostatin receptor subtypes ( sst1–3 , 5 ) . This study evaluated the safety , tolerability , pharmacokinetics , and pharmacodynamics profiles of pasireotide long-acting release ( LAR ) formulation in patients with advanced gastroenteropancreatic neuroendocrine tumor ( GEP NET ) refractory to other SSAs . Methods In this r and omized , multicenter , open-label , phase II study , patients with biopsy-proven primary or metastatic GEP NET refractory to available SSAs were r and omly assigned 1:1:1 to receive pasireotide LAR by deep intragluteal injection at a dose of 20 , 40 , or 60 mg once every 28 days for 3 months . Results Forty-two patients received pasireotide LAR . Adverse events were reported by 34 ( 81 % ) patients , with the most frequently reported including diarrhea , fatigue , abdominal pain , and nausea . Mean fasting glucose levels were increased compared with baseline at all points throughout the study . After the third injection of pasireotide LAR , the median trough plasma concentrations on day 84 were 4.82 , 12.0 , and 19.7 ng/mL in the 20- , 40- , and 60-mg treatment groups , respectively . Drug accumulation was limited for each dose based on the increase in trough concentrations after the first to third injections ( accumulation ratios were approximately 1 from all dose levels ) . Conclusions This study demonstrated that a new , once-monthly , intramuscular LAR formulation of pasireotide was well tolerated in patients with advanced GEP NET . Steady state levels of plasma pasireotide were achieved after three injections To evaluate the treatment of advanced islet-cell carcinoma , we r and omly assigned 84 patients to streptozocin alone or streptozocin plus fluorouracil . Each regimen was given in five-day courses . The most frequent toxic effects were nausea and vomiting , mild and reversible renal toxicity , and bone-marrow depression with the combination regimen . The combination had advantages over streptozocin alone in overall rate of response ( 63 vs. 36 per cent ) and in rates of complete response ( 33 vs. 12 per cent ) . There was no evidence of a preferential response among types of functional tumors . Objective responses were generally of long duration ( median , 17 months ) and of substantive clinical benefit . Treatment with the combination also yielded a survival advantage over treatment with streptozocin alone ( medians , 26 and 16 1/2 months ) , but this difference is not statistically significant . In spite of gastrointestinal side effects , streptozocin combined with fluorouracil appears to be a valuable treatment for advanced islet-cell carcinoma Background Several studies have demonstrated the antitumor activity of first-generation somatostatin analogs ( SSAs ) , primarily targeting somatostatin receptor ( sstr ) subtypes 2 and 5 , in neuroendocrine tumors ( NET ) . Pasireotide , a second-generation SSA , targets multiple sstr subtypes . We compared the efficacy and safety of pasireotide plus everolimus to everolimus alone in patients with advanced , well-differentiated , progressive pancreatic NET . Patients and methods Patients were r and omized 1 : 1 to receive a combination of everolimus ( 10 mg/day , orally ) and pasireotide long-acting release ( 60 mg/28 days , intramuscularly ) or everolimus alone ( 10 mg/day , orally ) ; stratified by prior SSA use , and baseline serum chromogranin A and neuron-specific enolase . The primary end point was progression-free survival ( PFS ) . Secondary end points included overall survival , objective response rate , disease control rate , and safety . Biomarker response was evaluated in an exploratory analysis . Results Of 160 patients enrolled , 79 were r and omized to the combination arm and 81 to the everolimus arm . Baseline demographics and disease characteristics were similar between the treatment arms . No significant difference was observed in PFS : 16.8 months in combination arm versus 16.6 months in everolimus arm ( hazard ratio , 0.99 ; 95 % confidence interval , 0.64 - 1.54 ) . Partial responses were observed in 20.3 % versus 6.2 % of patients in combination arm versus everolimus arm ; however , overall disease control rate was similar ( 77.2 % versus 82.7 % , respectively ) . No significant improvement was observed in median overall survival . Adverse events were consistent with the known safety profile of both the drugs ; grade 3 or 4 fasting hyperglycemia was seen in 37 % versus 11 % of patients , respectively . Conclusions The addition of pasireotide to everolimus was not associated with the improvement in PFS compared with everolimus alone in this study . Further studies to delineate mechanisms by which SSAs slow tumor growth in NET are warranted BACKGROUND Effective systemic therapies for patients with advanced , progressive neuroendocrine tumours of the lung or gastrointestinal tract are scarce . We aim ed to assess the efficacy and safety of everolimus compared with placebo in this patient population . METHODS In the r and omised , double-blind , placebo-controlled , phase 3 RADIANT-4 trial , adult patients ( aged ≥18 years ) with advanced , progressive , well-differentiated , non-functional neuroendocrine tumours of lung or gastrointestinal origin were enrolled from 97 centres in 25 countries worldwide . Eligible patients were r and omly assigned in a 2:1 ratio by an interactive voice response system to receive everolimus 10 mg per day orally or identical placebo , both with supportive care . Patients were stratified by tumour origin , performance status , and previous somatostatin analogue treatment . Patients , investigators , and the study sponsor were masked to treatment assignment . The primary endpoint was progression-free survival assessed by central radiology review , analysed by intention to treat . Overall survival was a key secondary endpoint . This trial is registered with Clinical Trials.gov , number NCT01524783 . FINDINGS Between April 3 , 2012 , and Aug 23 , 2013 , a total of 302 patients were enrolled , of whom 205 were allocated to everolimus 10 mg per day and 97 to placebo . Median progression-free survival was 11·0 months ( 95 % CI 9·2 - 13·3 ) in the everolimus group and 3·9 months ( 3·6 - 7·4 ) in the placebo group . Everolimus was associated with a 52 % reduction in the estimated risk of progression or death ( hazard ratio [ HR ] 0·48 [ 95 % CI 0·35 - 0·67 ] , p<0·00001 ) . Although not statistically significant , the results of the first pre-planned interim overall survival analysis indicated that everolimus might be associated with a reduction in the risk of death ( HR 0·64 [ 95 % CI 0·40 - 1·05 ] , one-sided p=0·037 , whereas the boundary for statistical significance was 0·0002 ) . Grade 3 or 4 drug-related adverse events were infrequent and included stomatitis ( in 18 [ 9 % ] of 202 patients in the everolimus group vs 0 of 98 in the placebo group ) , diarrhoea ( 15 [ 7 % ] vs 2 [ 2 % ] ) , infections ( 14 [ 7 % ] vs 0 ) , anaemia ( 8 [ 4 % ] vs 1 [ 1 % ] ) , fatigue ( 7 [ 3 % ] vs 1 [ 1 % ] ) , and hyperglycaemia ( 7 [ 3 % ] vs 0 ) . INTERPRETATION Treatment with everolimus was associated with significant improvement in progression-free survival in patients with progressive lung or gastrointestinal neuroendocrine tumours . The safety findings were consistent with the known side-effect profile of everolimus . Everolimus is the first targeted agent to show robust anti-tumour activity with acceptable tolerability across a broad range of neuroendocrine tumours , including those arising from the pancreas , lung , and gastrointestinal tract . FUNDING Novartis Pharmaceuticals Corporation BACKGROUND This was a two-stage , phase II trial of the dual phosphatidylinositol 3-kinase/mammalian target of rapamycin inhibitor BEZ235 in patients with everolimus-resistant pancreatic neuroendocrine tumours ( pNETs ) ( NCT01658436 ) . PATIENTS AND METHODS In stage 1 , 11 patients received 400 mg BEZ235 orally twice daily ( bid ) . Due to tolerability concerns , a further 20 patients received BEZ235 300 mg bid . Stage 2 would be triggered by a 16-week progression-free survival ( PFS ) rate of ≥60 % in stage 1 . RESULTS As of 30 June , 2014 , 29/31 patients had discontinued treatment . Treatment-related grade 3/4 adverse events were reported in eight ( 72.7 % ) patients at 400 mg and eight ( 40.0 % ) patients at 300 mg , including hyperglycaemia , diarrhoea , nausea , and vomiting . The estimated 16-week PFS rate was 51.6 % ( 90 % confidence interval=35.7 - 67.3 % ) . CONCLUSION BEZ235 was poorly tolerated by patients with everolimus-resistant pNETs at 400 and 300 mg bid doses . Although evidence of disease stability was observed , the study did not proceed to stage 2 BACKGROUND The multitargeted tyrosine kinase inhibitor sunitinib has shown activity against pancreatic neuroendocrine tumors in pre clinical models and phase 1 and 2 trials . METHODS We conducted a multinational , r and omized , double-blind , placebo-controlled phase 3 trial of sunitinib in patients with advanced , well-differentiated pancreatic neuroendocrine tumors . All patients had Response Evaluation Criteria in Solid Tumors-defined disease progression documented within 12 months before baseline . A total of 171 patients were r and omly assigned ( in a 1:1 ratio ) to receive best supportive care with either sunitinib at a dose of 37.5 mg per day or placebo . The primary end point was progression-free survival ; secondary end points included the objective response rate , overall survival , and safety . RESULTS The study was discontinued early , after the independent data and safety monitoring committee observed more serious adverse events and deaths in the placebo group as well as a difference in progression-free survival favoring sunitinib . Median progression-free survival was 11.4 months in the sunitinib group as compared with 5.5 months in the placebo group ( hazard ratio for progression or death , 0.42 ; 95 % confidence interval [ CI ] , 0.26 to 0.66 ; P<0.001 ) . A Cox proportional-hazards analysis of progression-free survival according to baseline characteristics favored sunitinib in all subgroups studied . The objective response rate was 9.3 % in the sunitinib group versus 0 % in the placebo group . At the data cutoff point , 9 deaths were reported in the sunitinib group ( 10 % ) versus 21 deaths in the placebo group ( 25 % ) ( hazard ratio for death , 0.41 ; 95 % CI , 0.19 to 0.89 ; P=0.02 ) . The most frequent adverse events in the sunitinib group were diarrhea , nausea , vomiting , asthenia , and fatigue . CONCLUSIONS Continuous daily administration of sunitinib at a dose of 37.5 mg improved progression-free survival , overall survival , and the objective response rate as compared with placebo among patients with advanced pancreatic neuroendocrine tumors . ( Funded by Pfizer ; Clinical Trials.gov number , NCT00428597 . ) Purpose Everolimus improved median progression-free survival by 6.4 months in patients with advanced pancreatic neuroendocrine tumors ( NET ) compared with placebo in the RADIANT-3 study . Here , we present the final overall survival ( OS ) data and data on the impact of biomarkers on OS from the RADIANT-3 study . Methods Patients with advanced , progressive , low- or intermediate- grade pancreatic NET were r and omly assigned to everolimus 10 mg/day ( n = 207 ) or placebo ( n = 203 ) . Crossover from placebo to open-label everolimus was allowed on disease progression . Ongoing patients were unblinded after final progression-free survival analysis and could transition to open-label everolimus at the investigator 's discretion ( extension phase ) . OS analysis was performed using a stratified log-rank test in the intent-to-treat population . The baseline levels of chromogranin A , neuron-specific enolase , and multiple soluble angiogenic biomarkers were determined and their impact on OS was explored . Results Of
Output:
| The experimental treatments led to increased incidence and risks of GI events compared to the control treatments ( P<0.05 ) .
Diarrhea was the most common GI event .
Additionally , GI NETs led to higher risk of GI events than pancreatic NETs . |
MS213542 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Introduction Critically ill patients are characterized by increased loss of muscle mass , partially attributed to sepsis and multiple organ failure , as well as immobilization . Recent studies have shown that electrical muscle stimulation ( EMS ) may be an alternative to active exercise in chronic obstructive pulmonary disease ( COPD ) and chronic heart failure ( CHF ) patients with myopathy . The aim of our study was to investigate the EMS effects on muscle mass preservation of critically ill patients with the use of ultrasonography ( US ) . Methods Forty-nine critically ill patients ( age : 59 ± 21 years ) with an APACHE II admission score ≥13 were r and omly assigned after stratification upon admission to receive daily EMS sessions of both lower extremities ( EMS-group ) or to the control group ( control group ) . Muscle mass was evaluated with US , by measuring the cross sectional diameter ( CSD ) of the vastus intermedius and the rectus femoris of the quadriceps muscle . Results Twenty-six patients were finally evaluated . Right rectus femoris and right vastus intermedius CSD decreased in both groups ( EMS group : from 1.42 ± 0.48 to 1.31 ± 0.45 cm , P = 0.001 control group : from 1.59 ± 0.53 to 1.37 ± 0.5 cm , P = 0.002 ; EMS group : from 0.91 ± 0.39 to 0.81 ± 0.38 cm , P = 0.001 control group : from 1.40 ± 0.64 to 1.11 ± 0.56 cm , P = 0.004 , respectively ) . However , the CSD of the right rectus femoris decreased significantly less in the EMS group ( -0.11 ± 0.06 cm , -8 ± 3.9 % ) as compared to the control group ( -0.21 ± 0.10 cm , -13.9 ± 6.4 % ; P < 0.05 ) and the CSD of the right vastus intermedius decreased significantly less in the EMS group ( -0.10 ± 0.05 cm , -12.5 ± 7.4 % ) as compared to the control group ( -0.29 ± 0.28 cm , -21.5 ± 15.3 % ; P < 0.05 ) . Conclusions EMS is well tolerated and seems to preserve the muscle mass of critically ill patients . The potential use of EMS as a preventive and rehabilitation tool in ICU patients with polyneuromyopathy needs to be further investigated . Trial Registration clinical trials.gov : Objectives : To investigate whether a daily exercise session , using a bedside cycle ergometer , is a safe and effective intervention in preventing or attenuating the decrease in functional exercise capacity , functional status , and quadriceps force that is associated with prolonged intensive care unit stay . A prolonged stay in the intensive care unit is associated with muscle dysfunction , which may contribute to an impaired functional status up to 1 yr after hospital discharge . No evidence is available concerning the effectiveness of an early exercise training intervention to prevent these detrimental complications . Design : R and omized controlled trial . Setting : Medical and surgical intensive care unit at University Hospital Gasthuisberg . Patients : Ninety critically ill patients were included as soon as their cardiorespiratory condition allowed bedside cycling exercise ( starting from day 5 ) , given they still had an expected prolonged intensive care unit stay of at least 7 more days . Interventions : Both groups received respiratory physiotherapy and a daily st and ardized passive or active motion session of upper and lower limbs . In addition , the treatment group performed a passive or active exercise training session for 20 mins/day , using a bedside ergometer . Measurements and Main Results : All outcome data are reflective for survivors . Quadriceps force and functional status were assessed at intensive care unit discharge and hospital discharge . Six-minute walking distance was measured at hospital discharge . No adverse events were identified during and immediately after the exercise training . At intensive care unit discharge , quadriceps force and functional status were not different between groups . At hospital discharge , 6-min walking distance , isometric quadriceps force , and the subjective feeling of functional well-being ( as measured with “ Physical Functioning ” item of the Short Form 36 Health Survey question naire ) were significantly higher in the treatment group ( p < .05 ) . Conclusions : Early exercise training in critically ill intensive care unit survivors enhanced recovery of functional exercise capacity , self-perceived functional status , and muscle force at hospital discharge BACKGROUND Skeletal muscle dysfunction and exercise intolerance are common in severe chronic obstructive pulmonary disease ( COPD ) . We assessed the effectiveness of neuromuscular electrical stimulation ( NMES ) as a home-based exercise therapy . METHODS In this double-blind , placebo-controlled trial , undertaken across three UK National Health Service sites , we r and omly assigned ( 1:1 ) adults with COPD , a forced expiratory volume in 1 s ( FEV1 ) less than 50 % predicted , and incapacitating breathlessness ( Medical Research Council dyspnoea scale ≥4 ) to receive active or placebo NMES , daily over a 6-week period . R and omisation was by an independent system using minimisation to balance age , GOLD stage , and quadriceps strength . Participants and outcome assessors were masked to group allocation . The primary endpoint was change in 6-min walk test ( 6MWT ) distance at 6 weeks . Analysis was by intention to treat . The trial was registered as IS RCT N15985261 and is now closed . FINDINGS Between June 29 , 2012 , and July 4 , 2014 , we enrolled 73 participants , of whom 52 participants were r and omly assigned ; 25 to receive active NMES and 27 to placebo NMES . Change in 6MWT distance was greater in the active NMES group ( mean 29·9 [ 95 % CI 8·9 to 51·0 ] ) compared with in the placebo group ( -5·7 [ -19·9 to 8·4 ] ; mean difference at 6 weeks 35·7 m [ 95 % CI 10·5 to 60·9 ] ; p=0·005 ) . Sensitivity analyses for complete-cases and adjustment for baseline values showed similar results . 6 weeks after stopping the intervention the effect waned ( 7·3 m [ 95 % CI -32·5 to 47·0 ] ; p=0·50 ) . The proportion of participants who had adverse events was similar between groups ( five [ 20 % ] in the active NMES group and nine [ 33 % ] in the placebo group ) . Two participants , one from each group , reported persistent erythema , which was considered to be possibly related to NMES and the use of adhesive electrodes . INTERPRETATION NMES improves functional exercise capacity in patients with severe COPD by enhancing quadriceps muscle mass and function . These data support the use of NMES in the management of patients unable to engage with conventional pulmonary rehabilitation . More work is needed to study how to maintain the effect . FUNDING National Institute for Health Research Introduction The purpose of this trial was to investigate the effectiveness of an exercise rehabilitation program commencing during ICU admission and continuing into the outpatient setting compared with usual care on physical function and health-related quality of life in ICU survivors . Methods We conducted a single-center , assessor-blinded , r and omized controlled trial . One hundred and fifty participants were stratified and r and omized to receive usual care or intervention if they were in the ICU for 5 days or more and had no permanent neurological insult . The intervention group received intensive exercises in the ICU and the ward and as out patients . Participants were assessed at recruitment , ICU admission , hospital discharge and at 3- , 6- and 12-month follow-up . Physical function was evaluated using the Six-Minute Walk Test ( 6MWT ) ( primary outcome ) , the Timed Up and Go Test and the Physical Function in ICU Test . Patient-reported outcomes were measured using the Short Form 36 Health Survey , version 2 ( SF-36v2 ) and Assessment of Quality of Life ( AQoL ) Instrument . Data were analyzed using mixed models . Results The a priori enrollment goal was not reached . There were no between-group differences in demographic and hospital data , including acuity and length of acute hospital stay ( LOS ) ( Acute Physiology and Chronic Health Evaluation II score : 21 vs 19 ; hospital LOS : 20 vs 24 days ) . No significant differences were found for the primary outcome of 6MWT or any other outcomes at 12 months after ICU discharge . However , exploratory analyses showed the rate of change over time and mean between-group differences in 6MWT from first assessment were greater in the intervention group . Conclusions Further research examining the trajectory of improvement with rehabilitation is warranted in this population .Trial registration The trial was registered with the Australian New Zeal and Clinical Trials Registry ACTRN12605000776606 Introduction Critical illness polyneuromyopathy ( CIPNM ) is a common complication of critical illness presenting with muscle weakness and is associated with increased duration of mechanical ventilation and weaning period . No preventive tool and no specific treatment have been proposed so far for CIPNM . Electrical muscle stimulation ( EMS ) has been shown to be beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary disease . Aim of our study was to assess the efficacy of EMS in preventing CIPNM in critically ill patients . Methods One hundred and forty consecutive critically ill patients with an APACHE II score ≥ 13 were r and omly assigned after stratification to the EMS group ( n = 68 ) ( age:61 ± 19 years ) ( APACHE II:18 ± 4 , SOFA:9 ± 3 ) or to the control group ( n = 72 ) ( age:58 ± 18 years ) ( APACHE II:18 ± 5 , SOFA:9 ± 3 ) . Patients of the EMS group received daily EMS sessions . CIPNM was diagnosed clinical ly with the medical research council ( MRC ) scale for muscle strength ( maximum score 60 , < 48/60 cut off for diagnosis ) by two unblinded independent investigators . Duration of weaning from mechanical ventilation and intensive care unit ( ICU ) stay were recorded . Results Fifty two patients could be finally evaluated with MRC ; 24 in the EMS group and 28 in the control group . CIPNM was diagnosed in 3 patients in the EMS group as compared to 11 patients in the control group ( OR = 0.22 ; CI : 0.05 to 0.92 , P = 0.04 ) . The MRC score was significantly higher in patients of the EMS group as compared to the control group [ 58 ( 33 to 60 ) vs. 52 ( 2 to 60 ) respectively , median ( range ) , P = 0.04 ) . The weaning period was statistically significantly shorter in patients of the EMS group vs. the control group [ 1 ( 0 to 10 ) days vs. 3 ( 0 to 44 ) days , respectively , median ( range ) , P = 0.003 ] . Conclusions This study suggests that daily EMS sessions prevent the development of CIPNM in critically ill patients and also result in shorter duration of weaning . Further studies should evaluate which patients benefit more from EMS and explore the EMS characteristics most appropriate for preventing CIPNM.Trial Registration Number Clinical Trials.gov OBJECTIVE It is known that patients in the intensive care unit show an enormous loss of muscle mass . Neuromuscular electrical stimulation is effective in enhancing strength and endurance in immobilized patients . The aim of this study was to evaluate the effects of neuromuscular electrical stimulation on muscle layer thickness of knee extensor muscles in intensive care unit patients . DESIGN R and omized , controlled , double-blind , pilot trial . PATIENTS Thirty-three patients , male to female ratio 26:7 , mean age 55 years ( st and ard deviation 15 ) . METHODS After enrolment in the study , intensive care unit patients ( main diagnoses : polytrauma , cardiovascular diseases , transplantation , pneumonia , cancer ) were stratified ( based on the length of their stay in hospital ) into 2 groups : 17 acute patients ( < 7 days ) and 16 long-term patients ( > 14 days ) . Both groups were r and omized to a stimulation group or a sham-stimulation group . Neuromuscular electrical stimulation was applied to knee extensor muscles for a period of 4 weeks ( session time 30 - 60 minutes , 5 days/week ) . Ultrasound measurements were performed before and after the stimulation period to quantify muscle layer thickness of knee extensor muscles . RESULTS Only stimulated long-term patients ( + 4.9 % ) showed a significant ( p = 0.013 ) increase in muscle layer thickness compared with sham-stimulated patients ( -3.2 % ) . CONCLUSION Neuromuscular electrical stimulation appears to be a useful adjunct to revert muscle wasting in intensive care unit long-term patients ; however , larger studies with a larger sample size are needed to confirm these promising , but preliminary , results Background The effects of neuromuscular electrical stimulation ( NMES ) in critically ill patients after cardiothoracic surgery are unknown . The objectives were to investigate whether NMES prevents loss of muscle layer thickness ( MLT ) and strength and to observe the time variation of MLT and strength from preoperative day to hospital discharge . Methods In this r and omized controlled trial ,
Output:
| Conclusions : NMES and exercise‐based interventions may preserve muscle mass and function in patients with critical illness .
There is a lack of consistency seen in the effects of these interventions .
HIGHLIGHTSNMES and exercise‐based interventions may preserve muscle mass and function . |
MS213543 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Abstract . To investigate whether age at onset of steroid-sensitive nephrotic syndrome ( SSNS ) is predictive of subsequent relapses , or influences outcome , we retrospectively studied 60 patients who were under 10 years of age at onset and were followed for over 10 years . They were divided into three groups according to age at diagnosis : group 1–3 ( 1.0–3.9 years at onset , n=24 ) , group 4–6 ( 4.0–6.9 years at onset , n=22 ) , and group 7–9 ( 7.0–9.9 years at onset , n=14 ) . In the 51 patients with long-term remission , defined as remaining relapse-free over 3 years , the total number of relapses was significantly more in group 1–3 ( n=18 ) than in group 4–6 ( n=19 ) , and the interval between onset and long-term remission was significantly longer . Group 4–6 and group 7–9 had fewer patients with active disease at 10 years , follow-up than group 1–3 , as assessed by the Kaplan-Meier method . These data suggest that the age at onset of SSNS influences the clinical course ( i.e. , frequency of relapses ) and the time to reach long-term remission . An age of less than 4 years at onset of SSNS is associated with greater likelihood for frequent relapses and a greater time interval to attain long-term remission Abstract We have examined , in a prospect i ve r and omized controlled trial , the effect of 8- and 16-week initial steroid treatment on the course of idiopathic nephrotic syndrome ( INS ) . Patients with a first episode of INS were r and omized to receive st and ard 8-week prednisolone ( 2 mg/kg daily for 4 weeks , then 1.5 mg/kg on alternate days for 4 weeks ) or prolonged 16-week prednisolone treatment ( 2 and 1.5 mg/kg daily each for 4 weeks , then 1.5 and 1 mg/kg on alternate days each for 4 weeks ) . Relapses were treated with prednisolone , 2 mg/kg daily for 2 weeks , then 1.5 mg/kg on alternate days for 4 weeks . Of 45 patients , 23 received st and ard therapy and 22 prolonged therapy . The mean duration of follow-up was 29.2 and 27.3 months in the st and ard and prolonged treatment groups , respectively . The time to first relapse was longer in the prolonged treatment ( mean 222.2 days , median 120.0 days ) than the st and ard group ( mean 134.3 days , median 96.5 days ) . The percentage of patients with no relapse at 6 and 12 months after prednisolone withdrawal was 40.9 % and 27.3 % in the prolonged treatment and 21.7 % and 8.7 % in the st and ard groups , respectively . The inability to show statistically significant differences between the two groups was probably related to the small number of patients studied . Prolonged therapy did not affect the subsequent relapse rates and proportion of patients with frequent relapses and steroid dependence . The mean dose of prednisolone received , for the initial episode and relapses during the next year , was higher and associated with significant steroid toxicity in the prolonged treatment group . Our findings suggest that 16-week prednisolone treatment for the initial episode of INS may delay occurrence of the first relapse , but results in significant side effects . Prolongation of initial therapy may be useful in developing countries where frequent infections often induce early relapses Two regimens of steroid treatment for the initial attack of idiopathic nephrotic syndrome ( NS ) in children were compared in a controlled prospect i ve multicentre study . Long prednisone therapy consisted of 60 mg/m2 per 24 h for 6 weeks , followed by alternate day 40 mg/m2 per 48 h for 6 weeks . The st and ard prednisone therapy was 60 mg/m2 per 24 h for 4 weeks , followed by 40 mg/m2 per 48 h for 4 weeks . A total of 71 children with an initial attack of idiopathic NS were allocated at r and om to the two groups . The cumulative rate of patients with sustained remissions after 2 years was significantly higher after the long course than after the st and ard treatment ( 49 % vs 19%,P=0.0079 ) . The mean relapse rate per patient at intervals of 3 , 6 and 12 months was lower in the long-course prednisone group than in the st and ard prednisone group , and the proportion of children with frequent relapses during any subsequent 6 months period was lower in the long-course group than in the st and ard group ( 29 % vs 57%,P=0.03 ) . Mild side-effects of corticosteroid therapy were observed more frequently after long-course prednisone treatment . It is concluded that long-course prednisone therapy of the initial attack of steroid responsive NS is preferable to the st and ard regimen because it reduces the rate of subsequent relapses without increasing the risk for severe steroidal side-effects Abstract Purpose The Strengths and Difficulties Question naire ( SDQ ) is a behavioural screening tool for children . The SDQ is increasingly used as the primary outcome measure in population health interventions involving children , but it is not preference based ; therefore , its role in allocative economic evaluation is limited . The Child Health Utility 9D ( CHU9D ) is a generic preference-based health-related quality of-life measure . This study investigates the applicability of the SDQ outcome measure for use in economic evaluations and examines its relationship with the CHU9D by testing previously published mapping algorithms . The aim of the paper is to explore the feasibility of using the SDQ within economic evaluations of school-based population health interventions . Methods Data were available from children participating in a cluster r and omised controlled trial of the school-based roots of empathy programme in Northern Irel and . Utility was calculated using the original and alternative CHU9D tariffs along with two SDQ mapping algorithms . t tests were performed for pairwise differences in utility values from the preference-based tariffs and mapping algorithms . Results Mean ( st and ard deviation ) SDQ total difficulties and prosocial scores were 12 ( 3.2 ) and 8.3 ( 2.1 ) . Utility values obtained from the original tariff , alternative tariff , and mapping algorithms using five and three SDQ subscales were 0.84 ( 0.11 ) , 0.80 ( 0.13 ) , 0.84 ( 0.05 ) , and 0.83 ( 0.04 ) , respectively . Each method for calculating utility produced statistically significantly different values except the original tariff and five SDQ subscale algorithm . Conclusion Initial evidence suggests the SDQ and CHU9D are related in some of their measurement properties . The mapping algorithm using five SDQ subscales was found to be optimal in predicting mean child health utility . Future research valuing changes in the SDQ scores would contribute to this research In this multicenter , open-label , r and omized controlled trial , we determined whether 2-month prednisolone therapy for steroid-sensitive nephrotic syndrome was inferior or not to 6-month therapy despite significantly less steroid exposure . The primary end point was time from start of initial treatment to start of frequently relapsing nephrotic syndrome . The pre-specified non-inferiority margin was a hazard ratio of 1.3 with one-sided significance of 5 % . We r and omly assigned 255 children with an initial episode of steroid-sensitive nephrotic syndrome to either 2 - or 6-month treatment of which 246 were eligible for final analysis . The total prednisolone exposure counted both initial and relapse prednisolone treatment administered over 24 months . Median follow-up in months was 36.7 in the 2-month and 38.2 in the 6-month treatment group . Time to frequent relaps was similar in both groups ; however , the median was reached only in the 6-month group ( 799 days ) . The hazard ratio was 0.86 ( 90 % confidence interval , 0.64–1.16 ) and met the non-inferior margin . Time to first relapse was also similar in both groups : median day 242 ( 2-month ) and 243 ( 6-month ) . Frequency and severity of adverse events were similar in both groups . Most adverse events were transient and occurred during initial or relapse therapy . Thus , 2 months of initial prednisolone therapy for steroid-sensitive nephrotic syndrome , despite less prednisolone exposure , is not inferior to 6 months of initial therapy in terms of time to onset of frequently relapsing nephrotic syndrome Objectives To compare the motives and experiences of different ethnic groups participating in a r and omised double blind placebo-controlled trial of montelukast in preschool wheeze , and to assess parents ’ or guardians ’ underst and ing of trial procedures and their implication s , including the collection of genetic material . Design Qualitative interviews with parents or guardians . Setting Interviews occurred in the homes of London children recruited to a national multicentre clinical trial following primary and secondary care attendance with wheeze . Participants 42 parents ( 20 of Bangladeshi origin , 10 white UK , 12 other ethnicities ) of preschool children enrolled in a clinical trial . Results Bangladeshi families were relatively reluctant to participate in the qualitative study , despite strong engagement with the parent study . Anxiety related to wheezing was a common primary motive for trial enrolment . Parents viewed the trial as a route to improved treatment . Verbal delivery of trial information appeared more effective than study literature , especially for Bangladeshi families , with low parental literacy and high levels of trust in medical professionals potential contributors to this effect . All ethnic groups expressed a low underst and ing and /or retention of essential study concepts such as r and omisation and genetic testing . Conclusions Bangladeshi families are particularly motivated to participate in clinical trials despite variable comprehension of study concepts . This motivation is more strongly contingent on strong research er-subject rapport than on the quality of study literature . Trial teams seeking to recruit from South Asian population s should emphasise face-to-face verbal explanation of trial concepts and procedures and consider modified trial literature A total of 184 children aged , 13 months to 11 years , suffering from their first attack of steroid-responsive nephrotic syndrome were included in a r and omized study . They were treated according to three treatment protocol s. All children received 1 - 2 mg of prednisone/kg body weight/day ( up to 80 mg daily ) for 4 weeks , and thereafter 1 mg/kg body weight/48 h for the next 4 weeks . Treatment was discontinued at this point in 44 children ( protocol A ) ; in 68 ( protocol B ) the dose was reduced by 25 % each week , tapering off to 0 at the end of the third month , while in 72 children ( protocol C ) , after the first 2 months of initial treatment the dose was reduced by 25 % each month and tapered off to 0 by the end of the sixth month . All patients completed a 2-year follow-up period after withdrawal of prednisone . Treatment results were expressed as : percentage of children relapse-free within the first 6 months and 2 years after withdrawal of treatment , and average number of relapses per patient per year . The best results were obtained in children who had been treated for 6 months ; 65.3 % of them remained relapse-free within the first 6 months and 50 % over the entire 2-year follow-up period ; the number of relapses per patient per year in this group was 0.49 . The respective values for children treated 2 and 3 months were : 36.4 % and 32.4 % for the 6-month period ; 27.3 % and 20.6 % for the 2-year period ; the numbers of relapses per patient per year were 0.79 and 0.77 , respectively . ( ABSTRACT TRUNCATED AT 250 WORDS Ninety six patients aged from 6 months to 15 years and were admitted to Chilean hospitals with the diagnosis of primary nephrotic syndrome in a period of 30 months . These patients were r and omly separated in two groups , group A received prednisone for 8 weeks and group B received the same drug during 12 weeks . All patients were evaluated at 6 , 12 and 18 months after the end of treatment . The moment and number of relapses per patient , accumulated percentage of relapses , relapse rate per 100 patients , total number of relapses and complications were assessed . Frequent relapsers were subjected to a kidney biopsy , leaving in the protocol only those patients that had minimal changes . Patients resistant or dependent to steroid therapy were discarded . Thus we report the results of 56 treated patients followed during 18 months . No differences in analyzed parameters were observed between the two treatment groups . It is concluded that these preliminary results do not support the prolongation of prednisone treatment in children with primary nephrotic syndrome One hundred and fourteen children with primary nephrotic syndrome were followed up prospect ively for periods of between 5 and 14 years . Urine sample s from 94 of them became protein-free during the initial 8-week course of prednisone , and the outcome for these children was good : 74 of them have been free of symptoms for at least 3 years , 18 have had relapses during the last 3 years , and only one child still has proteinuria . All these children have normal renal function and blood pressure . One child died accidentally . Twenty children did not respond to the initial prednisone treatment . Thirteen of them had remissions later , of whom 2 have had relapses during the last 3 years . Seven were totally resistant to prednisone 4 of whom died in renal failure , the remaining 3 have persistent proteinuria with normal levels of creatinine ; one has high blood pressure too . Remission during the initial treatment indicated a good prognosis , but two-thirds of the
Output:
| LIMITATIONS Study drug formulation may have prevented some younger children who were unable to swallow whole or crushed tablets from participating .
This trial has not shown any clinical benefit for EC prednisolone therapy in UK children .
The cost-effectiveness analysis suggested that EC therapy may be cheaper , with the possibility of a small QALY benefit . |
MS213544 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Purpose To examine the effects of iv compound sodium lactate ( CSL ) with and without caloric supplementation with dextrose on nausea , vomiting and pain following general anesthesia for laparoscopy . Methods We compared iv fluid loading with and without supplementary dextrose for the prevention of postoperative nausea and vomiting ( PONV ) . In a prospect i ve double-blinded controlled trial , 120 ASA I female patients undergoing elective gynecological laparoscopy were r and omized to one of three groups , and received either : ( a ) CSL 1.5 mL·kg−1 per hour fasting duration ; ( b ) CSL , 1.5 mL·kg−1 per hour fasting duration with 0.5 g·kg−1 dextrose added in 50 % formulation ( CSL/dextrose ) ; or ( c ) no iv fluid ( control ) . Results Compared with control the percentage of patients who had no PONV within 24 hr of anesthesia in the CSL and CSL/dextrose groups was 78 % vs 83 % and 71 % , P = 0.81 and P = 0.683 respectively . The numbers needed-to-harm for causing PONV episodes in CSL/dextrose vs CSL or control groups were 5.7 [ 95 % confidence interval ( CI ) , 5.57–5.91 ] and 8.2 ( 95 % Cl , 8.01–8.37 ) respectively . The number needed-to-treat for prevention of PONV episodes in CSL vs control was 19.2 ( 95 % Cl , 19.08–19.37 ) . A greater proportion of patients in the CSL/dextrose group required narcotic analgesia in the postanesthetic care unit compared to those in the control group ( 16/35 vs 7/37 , P = 0.03 ) . The CSL/dextrose group also demonstrated hyperglycemia ( serum glucose 14.0 ± 3.94 vs 5.0 ± 1.01 vs 5.2 ± 0.9 mmol·L−1 , P < 0.0001 ) in the postanesthetic care unit compared to the CSL and control groups . The CSL/dextrose group also reported increased thirst at 24 hr compared to control ( 20/35 vs 11/37 , P = 0.035 ) . Conclusion These findings suggest that : I ) administration of dextrose is associated with nausea , increased opioid requirement and late thirst after elective gynecological laparoscopy ; 2 ) iv fluids did not decrease PONVRésuméObjectifVérifier les effets d’un lactate de sodium composé iv ( LSC ) , avec et sans apport calorique complémentaire avec du dextrose , sur les nausées , les vomissements et la douleur après une anesthésie générale pour laparoscopie . MéthodeNous avons comparé une charge liquidienne avec et sans dextrose supplémentaire comme prévention des nausées et vomissements postopératoires ( NVPO ) . Une étude prospect i ve , contrôlée et à double insu a été réalisée auprès de 120 femmes d’état physique ASA I devant subir une laparoscopie gynécologique réglée . Les patientes , réparties en trois groupes , ont reçu : ( a ) 1,5 mL·kg−1 de LSC par heure de jeûne ; ( b ) 1,5 mL·kg−1 de LSC par heure de jeûne avec 0,5 g·kg−1 de dextrose ajouté dans une préparation à 50 % ( LSC/dextrose ) ou ( c ) aucun soluté (témoin).RésultatsComparé à celui des témoins , le pourcentage de patientes sans NVPO pendant les 24 h qui ont suivi l’anesthésie dans les groupes LSC et LSC/dextrose a été respectivement de 78 % vs 83 % et 71 % , P = 0,81 et P = 0,683 . Le nombre de patientes lésées , nécessaire pour causer des NVPO dans le groupe LSC/dextrose vs les groupes LSC ou témoin a été respectivement de 5,1 [ intervalle de confiance de 95 % ( IC ) , 5,57 - 5,91 ] et 8,2 ( IC de 95 % , 8,01 - 8,37 ) . Le nombre nécessaire à traiter pour prévenir les NVPO dans le groupe LSC vs le groupe témoin a été de 19,2 ( IC de 95 % , 19,08 - 19,37 ) . Plus de patientes du groupe LSC/dextrose ont eu besoin d’analgésique narcotique en salle de réveil , comparées aux patientes témoins ( 16/35 vs 7/37 , P = 0,03 ) . À la salle de réveil , on a aussi trouvé de l’hyperglycémie dans le groupe LSC/dextrose ( glucose sérique de 14,0 ± 3,94 vs 5,0 ± 1,01 vs 5,2 ± 0,9 mmol·L−1 , P < 0,0001 ) , comparé aux groupes LSC et témoin . À 24 h , le groupe LSC/dextrose , comparé aux témoins , a aussi présenté une augmentation de la soif , ( 20/35 vs 11/37 , P = 0,035 ) . Conclusion Ces résultats suggèrent que : I ) l’administration de dextrose est associée aux nausées , à des besoins accrus d’opioïde et une soif tardive à la suite d’une laparoscopie gynécologique ; 2 ) les liquides iv ne diminuent pas les NVPO BACKGROUND : Postoperative nausea and vomiting ( PONV ) may occur despite antiemetic prophylaxis and is associated with unanticipated hospital admission , financial impact , and patient dissatisfaction . Previous studies have shown variable impact of IV dextrose on PONV . We sought to determine the relationship of IV dextrose administered during emergence from anesthesia to PONV . METHODS : This was a prospect i ve , double-blind r and omized placebo-controlled trial . Adult female ASA physical status I and II nondiabetic patients scheduled for outpatient gynecologic , urologic , or breast surgery were r and omly assigned to infusion of 250 mL lactated Ringer ’s solution ( group P ; n = 75 ) or dextrose 5 % in lactated Ringer ’s solution ( group D ; n = 87 ) over 2 hours beginning with surgical closing . Blood glucose was determined using a point-of-care device before transfer to the operating room , in the operating room immediately before study fluid infusion , and in the recovery room after study fluid infusion . No antiemetics were given before arrival in the recovery room . PONV scores were recorded at 0 , 30 , 60 , and 120 minutes and 24 hours after arrival in the recovery room . Medication administration was recorded . RESULTS : Data from 162 patients with normal baseline blood glucose were analyzed . There were no significant intergroup differences in demographics , history of PONV , or tobacco use . There was no significant intergroup difference in PONV during the first 2 hours after anesthesia ( group D 52.9 % vs group P 46.7 % ; difference , 6.2 % ; 95 % confidence interval [ CI ] , −9.2 % to 21.6 % ; P = 0.43 ) . Patients in groups D or P who developed PONV within 2 hours of anesthesia had similar number of severity scores ≥1 during recovery stay ( 1.5 vs 1.0 ; difference , 0 ; 95 % CI , 0%–0 % ; P = 0.93 ) ; and similar proportions of : PONV onset within 30 minutes of recovery room arrival ( 65.2 % vs 57.1 % ; difference , 8.1 % ; 95 % CI , −13.1 % to 28.8 % ; P = 0.46 ) ; more than 1 dose of antiemetic medication ( 56.5 % vs 62.9 % ; difference , 6.3 % ; 95 % CI , −26.9 % to 15.1 % ; P= 0.65 ) ; or more than 1 class of antiemetic medication ( 50.0 % vs 54.3 % ; difference , 4.3 % ; 95 % CI , −25.5 % to 17.4 % ; P = 0.82 ) . CONCLUSIONS : The administration of dextrose during emergence from anesthesia was not associated with a difference in the incidence of PONV exceeding 20 % or in the severity of PONV in the first 2 hours after anesthesia . The relationship between PONV and the optimal dose and timing of IV dextrose administration remains unclear and may warrant further study BACKGROUND : Postoperative nausea and vomiting ( PONV ) remains the most common postoperative complication , and causes decreased patient satisfaction , prolonged postoperative hospital stays , and unanticipated admission . There are limited data that indicate that dextrose may reduce nausea and vomiting . In this trial , we attempted to determine whether the rate of PONV can be decreased by postoperative administration of IV dextrose bolus . METHODS : To test the effect of postoperative dextrose administration on PONV rates , we conducted a double-blind , r and omized , placebo-controlled trial . We enrolled 62 nondiabetic , ASA class I or II nonsmoking out patients scheduled for gynecologic laparoscopic and hysteroscopic procedures . Patients were r and omized into 2 groups : the treatment group received dextrose 5 % in Ringer lactate solution , and the control ( placebo ) group received Ringer lactate solution given immediately after surgery . All patients underwent a st and ardized general anesthesia and received 1 dose of antiemetic a half hour before emergence from anesthesia . PONV scores , antiemetic rescue medications , narcotic consumption , and discharge time were recorded in the postanesthesia care unit ( PACU ) in half-hour intervals . RESULTS : The 2 groups were similar with regard to age , weight , anxiety scores , prior PONV , non per os status , presurgical glucose , anesthetic duration , intraoperative narcotic use , and total weight-based fluid volume received . Postoperative nausea scores were not significantly different in the dextrose group compared with the control group ( P > 0.05 ) after Bonferroni correction for repeated measurements over time . However , patients who received dextrose 5 % in Ringer lactate solution consumed less rescue antiemetic medications ( ratio mean difference , 0.56 ; 95 % confidence interval , 0.39–0.82 ; P = 0.02 ) , and had a shorter length of stay in the PACU ( ratio mean difference , 0.80 ; 95 % confidence interval , 0.66–0.97 ; P = 0.03 ) compared with patients in the control group . CONCLUSION : In this trial , postanesthesia IV dextrose administration result ed in improved PONV management as defined by reductions in antiemetic rescue medication requirements and PACU length of stay that are worthy of further study . In light of its ease , low risk , and benefit to patient care and satisfaction , this therapeutic modality could be considered Background and Aims : Post-operative nausea and vomiting ( PONV ) is a common and distressing complication after laparoscopic cholecystectomy ( LC ) . The aim of this study was to evaluate the effect of intravenous ( IV ) dextrose administration for the prophylaxis of PONV after LC . Methods : In a double-blind , r and omised controlled trial , a total of 150 female patients who were scheduled for elective LC were r and omly assigned into two groups ( A and B ) . Thirty minutes before induction of anaesthesia , patients received an infusion of 500 cc lactated Ringer 's solution ( Group A ) and 5 % dextrose in lactated Ringer 's solution ( Group B ) and over a period of 30 min . All patients rated their nausea and vomiting intensity using the verbal rating scale immediately at post-anaesthesia care unit ( PACU ) arrival ; 30 , 60 , 90 and 120 min after arriving at the PACU and 6 , 12 and 24 h after surgery . Results : There was a statistically significant time trend and group effect along with significant differences in time/group interaction effect in both groups for nausea and vomiting scores ( P < 0.05 ) . A low negative correlation coefficient was found ( r = −0.394 , P < 0.001 ) between blood glucose levels and nausea scores upon PACU arrival . Dextrose administration reduced the odds of vomiting events compared to placebo ( estimate : −0.87 , odds ratio = 0.42 , 95 % confidence interval : 0.28–0.64 ) . Conclusion : Administration of IV dextrose before anaesthesia induction may be recommended as an effective , and safe method for the prophylaxis of PONV after LC The potential for preoperative IV rehydration to reduce postoperative nausea and vomiting ( PONV ) and pain in patients undergoing ambulatory surgery remains unclear , with conflicting results reported . We sought to determine whether preoperative IV rehydration with a balanced salt solution would decrease the incidence of PONV in patients at increased risk for these symptoms . Eighty ASA grade I – III patients presenting for gyne
Output:
| Compared with placebos , perioperative intravenous dextrose administration may decrease postoperative nausea but not vomiting . |
MS213545 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND S In China , the prevalence of chronic obstructive pulmonary disease ( COPD ) in persons 40 years of age or older is estimated at 8.2 % , but this is likely a substantial underestimate . METHODS Eight secondary hospitals which did n't have spirometries were chosen r and omly in Hunan province of central south China . Physician subjects at these hospitals underwent a one-hour training course on the Chinese COPD guidelines . Physicians answered question naires assessing their knowledge of the guidelines before and after the training session . The mean correct scores of question naires were compared before and after training . Four out of the eight hospitals were given access to spirometry . Eligible patient subjects underwent spirometry testing prior to the physician visit . After seeing the patient , physicians were asked to answer a question naire relating to the diagnosis and severity of COPD . Physicians were then given the results of the spirometry , and asked to answer the same question naire . Physicians ' responses before and after receiving the spirometry results were compared . RESULTS 225 physicians participated in the training session . 207 question naires were completed . Mean scores ( out of 100 ) before and after the training were 53.1 ± 21.7 and 93.3 ± 9.8 , respectively . 18 physicians and 307 patient subjects participated in the spirometry intervention . Based on spirometric results , the prevalence of COPD was 38.8 % . Physicians correctly identified the presence of COPD without spirometric data in 85 cases ( 76.6 % ) ; this increased to 117 cases ( 97.4 % ) once spirometric data were available . Without spirometric data , physicians incorrectly diagnosed COPD in 38 patients ; this decreased to 6 patients once spirometric data were available . Spirometric data also improved the ability of physicians to correctly grade COPD severity . CONCLUSIONS Simple educational training can substantially improve physicians ' knowledge relating to COPD . Spirometry combined with education improves the ability of physicians to diagnose COPD and to assess its severity The aim of this study was to test the hypothesis that use of tiotropium , a new long-acting anticholinergic bronchodilator , would be associated with sustained reduction in lung hyperinflation and , thereby , would improve exertional dyspnoea and exercise performance in patients with chronic obstructive pulmonary disease . A r and omised , double-blind , placebo-controlled , parallel-group study was conducted in 187 patients ( forced expiratory volume in one second 44±13 % pred ) : 96 patients received 18 µg tiotropium and 91 patients received placebo once daily for 42 days . Spirometry , plethysmographic lung volumes , cycle exercise endurance and exertional dyspnoea intensity at 75 % of each patient 's maximal work capacity were compared . On day 42 , the use of tiotropium was associated with the following effects at pre-dose and post-dose measurements as compared to placebo : vital capacity and inspiratory capacity ( IC ) increased , with inverse decreases in residual volume and functional residual capacity . Tiotropium increased post-dose exercise endurance time by 105±40 s ( 21 % ) as compared to placebo on day 42 . At a st and ardised time near end-exercise ( isotime ) , IC , tidal volume and minute ventilation all increased , whilst dyspnoea decreased by 0.9±0.3 Borg scale units . In conclusion , the use of tiotropium was associated with sustained reductions of lung hyperinflation at rest and during exercise . Result ant increases in inspiratory capacity permitted greater expansion of tidal volume and contributed to improvements in both exertional dyspnoea and exercise endurance BACKGROUND COPD ranks within the top three causes of mortality in the global burden of disease , yet it remains largely underdiagnosed . We assessed the underdiagnosis of COPD and its determinants in national and international surveys of general population s. METHODS We analyzed representative sample s of adults aged ≥ 40 years r and omly selected from well-defined administrative areas worldwide ( 44 sites from 27 countries ) . Postbronchodilator FEV1/FVC < lower limit of normal ( LLN ) was used to define chronic airflow limitation consistent with COPD . Undiagnosed COPD was considered when participants had postbronchodilator FEV1/FVC < LLN but were not given a diagnosis of COPD . RESULTS Among 30,874 participants with a mean age of 56 years , 55.8 % were women , and 22.9 % were current smokers . Population prevalence of ( spirometrically defined ) COPD ranged from 3.6 % in Barranquilla , Colombia , to 19.0 % in Cape Town , South Africa . Only 26.4 % reported a previous lung function test , and only 5.0 % reported a previous diagnosis of COPD , whereas 9.7 % had a postbronchodilator FEV1/FVC < LLN . Overall , 81.4 % of ( spirometrically defined ) COPD cases were undiagnosed , with the highest rate in Ile-Ife , Nigeria ( 98.3 % ) and the lowest rate in Lexington , Kentucky ( 50.0 % ) . In multivariate analysis , a greater probability of underdiagnosis of COPD was associated with male sex , younger age , never and current smoking , lower education , no previous spirometry , and less severe airflow limitation . CONCLUSIONS Even with substantial heterogeneity in COPD prevalence , COPD underdiagnosis is universally high . Because effective management strategies are available for COPD , spirometry can help in the diagnosis of COPD at a stage when treatment will lead to better outcomes and improved quality of life OBJECTIVE To determine the quality of spirometry performed in primary care practice and to assess the impact of formal training . DESIGN R and omized , controlled prospect i ve interventional study . SETTING Primary care practice , Auckl and City , New Zeal and . PARTICIPANTS Thirty r and omly selected primary care practice s r and omized to " trained " or " usual " groups . One doctor and one practice nurse were nominated to participate from each practice . INTERVENTIONS " Trained " was defined as participation in an " initial " spirometry workshop at week 0 and a " maintenance of st and ards " workshop at week 12 . " Usual " was defined as no formal training until week 12 , when participants they attended the same " initial " workshop provided for the trained group . The study duration was 16 weeks . Each practice was provided with a spirometer to be used at their clinical discretion . MEASUREMENTS AND RESULTS Spirometry data were uploaded weekly and analyzed using American Thoracic Society ( ATS ) criteria for acceptability and reproducibility . The workshops were assessed objective ly with practical and written assessment s , confirming a significant training effect . However , analysis of spirometry performed in clinical practice by the trained practitioners revealed three acceptable blows in only 18.9 % of patient tests . In comparison , 5.1 % of patient tests performed by the usual practitioners had three acceptable blows ( p<0.0001 ) . Only 13.5 % of patient tests in the trained group and 3.4 % in the usual group ( p<0.0001 ) satisfied full acceptability and reproducibility criteria . However , 33.1 % and 12.5 % of patient tests in the trained and usual groups , respectively ( p<0.0001 ) , achieved at least two acceptable blows , the minimum requirement . Nonacceptability was largely ascribable to failure to satisfy end-of-test criteria ; a blow of at least 6 s. Visual inspection of the results of these blows as registered on the spirometer for the presence of a plateau on the volume-time curve suggests that < 15 % were acceptable . CONCLUSIONS Although a significant training effect was demonstrated , the quality of the spirometry performed in clinical practice did not generally satisfy full ATS criteria for acceptability and reproducibility . Further study would be required to determine the clinical impact . However , the ATS guidelines allow for the use of data from unacceptable or nonreproducible maneuvers at the discretion of the interpreter . Since most of the failures were end-of-test related , the FEV1 levels are likely to be valid . Our results serve to emphasize the importance of effective training and quality assurance programs to the provision of successful spirometry in primary care practice Unreported chronic obstructive pulmonary disease ( COPD ) exacerbations are common , but their intermediate-to-long-term impacts on health-related quality of life ( HRQoL ) are unknown . The aim of the present study was to examine the impact of unreported exacerbations on HRQoL at 1 yr . A multicentric prospect i ve cohort study in 491 COPD patients was conducted in China . HRQoL was measured using the St George 's Respiratory Question naire ( SGRQ ) . Other measurements included sociodemographic , clinical , psychosocial and treatment profiles . Patients were monitored monthly for 12 months to document exacerbations ( at least one symptom worsening for ≥48 h ) . Patients were categorised into six groups : no exacerbation , one unreported exacerbation only , more than one unreported exacerbation only , one reported exacerbation only , more than one reported exacerbation only , and both unreported and reported exacerbations . Generalised estimating equations were used to estimate the adjusted associations between exacerbations and HRQoL change . A total of 466 unreported and 410 reported exacerbations were recorded . Compared with patients with no exacerbations , the change in SGRQ total score was similar amongst patients with one unreported exacerbation ( adjusted mean change 1.22 points ( 95 % CI -4.05–6.48 ) ) , but significantly worse among patients with more than one unreported exacerbation ( 4.61 ( 95 % CI 0.09–9.13 ) ) . Development and evaluation of self-management programmes emphasising early recognition of exacerbations and consequent action appear to be warranted BACKGROUND Patients with chronic obstructive pulmonary disease ( COPD ) and asthma depend on inhalers for management , but critical errors committed during inhaler use can limit drug effectiveness . Outpatient education in inhaler technique remains inconsistent due to limited re sources and inadequate provider knowledge . OBJECTIVE To determine whether a simple , two-session inhaler education program can improve physician attitudes toward inhaler teaching in primary care practice . METHODS An inhaler education program with small-group h and s-on device training was instituted for family physicians ( FP ) in British Columbia and Alberta . Sessions were spaced one to three months apart . All critical errors were corrected in the first session . Question naires surveying current inhaler teaching practice s and attitudes toward inhaler teaching were distributed to physicians before and after the program . RESULTS Forty-one ( 60 % ) of a total 68 participating FPs completed both before and after program question naires . Before the program , only 20 ( 49 % ) reported providing some form of inhaler teaching in their practice s , and only four ( 10 % ) felt fully competent to teach patients inhaler technique . After the program , 40 ( 98 % ) rated their inhaler teaching as good to excellent . Thirty-four ( 83 % ) reported providing inhaler teaching in their practice s , either by themselves or by an allied health care professional they had personally trained . All stated they could teach inhaler technique within 5 min . Observation of FPs during the second session by certified respiratory educators found that none made critical errors and all had excellent technique . CONCLUSION A physician inhaler education program can improve attitudes toward inhaler teaching and facilitate implementation in clinical practice BACKGROUND Chronic obstructive pulmonary disease ( COPD ) is characterized by an incompletely reversible limitation in airflow . A physiological variable -- the forced expiratory volume in one second (FEV1)--is often used to grade the severity of COPD . However , patients with COPD have systemic manifestations that are not reflected by the FEV1 . We hypothesized that a multidimensional grading system that assessed the respiratory and systemic expressions of COPD would better categorize and predict outcome in these patients . METHODS We first evaluated 207 patients and found that four factors predicted the risk of death in this cohort : the body-mass index ( B ) , the degree of airflow obstruction ( O ) and dyspnea ( D ) , and exercise capacity ( E ) , measured by the six-minute-walk test . We used these variables to construct the BODE index , a multidimensional 10-point scale in which higher scores indicate a higher risk of death . We then prospect ively vali date d the index in a cohort of 625 patients , with death from any cause and from respiratory causes as the outcome variables . RESULTS There were 25 deaths among the first 207 patients and 162 deaths ( 26 percent ) in the validation cohort . Sixty-one percent of the deaths in the validation cohort were due to respiratory insufficiency , 14 percent to myocardial infa rct ion , 12 percent to lung cancer , and 13 percent to other causes . Patients with higher BODE scores were at higher risk for death ; the hazard ratio for death from any cause per one-point increase in the BODE score was 1.34 ( 95 percent confidence interval , 1.26 to 1.42 ; P<0.001 ) , and the hazard ratio for death from respiratory causes was 1.62 ( 95 percent confidence interval , 1.48 to 1.77 ; P<0.001 ) . The C statistic for the ability of the BODE index to predict the risk of death was larger than that for the FEV1 ( 0.74 vs. 0.65 ) . CONCLUSIONS The BODE index , a simple multidimensional grading system , is better than the FEV1 at predicting the
Output:
| Simple educational training can substantially improve physicians ' knowledge relating to COPD diagnosis .
Similarly , a physician inhaler education program can improve attitudes toward inhaler teaching and facilitate its implementation in routine clinical practice s. Spirometry combined with inhaled technique education improves the ability of predominantly nonrespiratory physicians to correctly diagnose COPD , to adequately assess its severity , and to increase the percentage of correct COPD treatment used in a real-life setting |
MS213546 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Despite aggressive and innovative therapy , patients with multiple myeloma ( MM ) invariably relapse and die of their disease . New options for non‐cytotoxic salvage therapy and additional therapeutic strategies are needed . Arsenic trioxide , an antitumour agent with a multifaceted mechanism of action , induces apoptosis in vitro in MM cell lines and freshly isolated cells from MM patients and , in preliminary studies , displayed clinical activity in patients with late‐stage MM . A phase 2 , multicentre , open‐label study of arsenic trioxide was conducted in 24 MM patients ; eight had relapsed and 16 were refractory to prior therapy . Patients received arsenic trioxide 0·25 mg/kg/d for 5 d/week during the first 2 weeks of each 4‐week cycle . Sixteen patients had grade 3 or 4 neutropenia and one required antibiotics . Reductions ( 25 % or more ) in serum M‐protein levels occurred in eight of 24 ( 33 % ) patients . An additional six ( 25 % ) patients had stable disease . The median time to response was 67·5 d , with a median duration of response of 130 d. Arsenic trioxide therapy lowered serum creatinine levels in two patients with high baseline values . These data indicate that arsenic trioxide is active and reasonably well tolerated as a single‐agent salvage therapy , even in patients with late‐stage , relapsed and refractory MM In patients with multiple myeloma , there is pre clinical justification to combine arsenic trioxide ( ATO and As(2)O(3 ) ) with DVd ( Doxiltrade mark , vincristine , and dexamethasone ) for newly diagnosed patients . Eleven patients on this phase II trial received 0.15 mg/kg of ATO for five consecutive days followed by four cycles of DVd plus ATO with the ATO at 0.25mg/kg IV twice per week . The most common grade 3 toxicities were hyperglycemia , hyponatremia , and hypocalcemia . There were four partial and no complete responses . We could not demonstrate that the addition of ATO with this schedule improved the response rate of MM to DVd Arsenic has been used since ancient times as a therapeutic agent . However , until recently its use in modern medicine has been restricted to the treatment of a limited number of parasitic infections . In the early 1990s , reports from China described impressive results with arsenic trioxide in patients with de novo , relapsed , and refractory acute promyelocytic leukemia ( APL ) . Other investigators subsequently confirmed these results leading to approval of its use for relapsed or refractory APL in the United States . Investigations of this agent have demonstrated that its efficacy in APL and pre clinical tumor models is dependent upon a number of mechanisms , including induction of apoptosis , effects on cellular differentiation , cell cycling , and tumor angiogenesis . Subsequent pre clinical studies showed significant activity of arsenic trioxide in multiple myeloma ( MM ) . Based on this , in a phase II trial , we have evaluated the activity of arsenic trioxide in 14 patients with relapsed MM , refractory to conventional salvage therapy . With the dose and schedule used , treatment with arsenic trioxide produced responses in three patients and prolonged stable disease in a fourth patient , with the longest response lasting 6 weeks . Although treatment was reasonably well tolerated , in these patients with extensive prior therapy , 11 developed cytopenia , five associated with infectious complications and three developed deep vein thromboses . The results of this small trial support further investigation of this novel drug for the treatment of patients with relapsed or refractory MM Multiple myeloma ( MM ) characterized by proliferation of plasma cells in bone marrow and production of monoclonal immunoglobulin 's . Recently , arsenic trioxide ( ATO ) , has been considered for treatment refractory MM . We assessed the safety and efficacy of ATO for patients with refractory MM . A phase 2 , study of arsenic trioxide was conducted in 12 MM patients , whose refractory to two st and ard therapy . Patients received arsenic trioxide , 0.25 mg/kg/d for 5 d/week during the first 2 consecutive weeks of each 4-week cycle with 2 week rest . Patients who completed one 4-week cycle were evaluated for response to treatment . Twelve patients with refractory multiple myeloma received ATO . Disease assessment was based the amount of serum proteins electrophoresis . Of the10 patients ; stable disease was observed in four patients ( 33 % ) , progression disease in five patients ( 41.6 % ) , complete response in one patient ( 3.8 % ) and the remaining two patients could not be assessed for a response ( because of increased liver enzymes after the first week ) . Some adverse events : increase liver enzymes and serum creatinine , neutropenia , pruritus , nausea , vomiting , lower extremities edema , noninfectious diarrhea was observed . These results indicate that ATO is active and well tolerated as a single-agent salvage therapy , even in patients with late-stage , refractory MM We assessed the safety and efficacy of melphalan , arsenic trioxide ( ATO ) and ascorbic acid ( AA ) ( MAC ) combination therapy for patients with multiple myeloma ( MM ) who failed more than two different prior regimens . Patients received melphalan ( 0·1 mg/kg p.o . ) , ATO ( 0·25 mg/kg i.v . ) and AA ( 1 g i.v ) on days 1–4 of week 1 , ATO and AA twice weekly during weeks 2–5 and no treatment during week 6 of cycle 1 ; during cycles 2–6 , the schedule remained the same except ATO and AA were given twice weekly in week 1 . Objective responses occurred in 31 of 65 ( 48 % ) patients , including two complete , 15 partial and 14 minor responses . Median progression‐free survival and overall survival were 7 and 19 months respectively . Twenty‐two patients had elevated serum creatinine levels ( SCr ) at baseline , and 18 of 22 ( 82 % ) showed decreased SCr levels during treatment . Specific grade 3/4 haematological ( 3 % ) or cardiac adverse events occurred infrequently . Frequent grade 3/4 non‐haematological adverse events included fever/chills ( 15 % ) , pain ( 8 % ) and fatigue ( 6 % ) . This steroid‐free regimen was effective and well tolerated in this heavily pretreated group . These results indicate that the MAC regimen is a new therapeutic option for patients with relapsed or refractory MM Arsenic trioxide ( ATO ) is synergistic with ascorbic acid ( AA ) and melphalan against myeloma both in vitro and in vivo . The aim of this r and omized phase II trial was to determine the safety and efficacy of a combination of ATO , melphalan , and AA as preparative regimen in 48 patients undergoing autologous hematopoietic stem cell transplantation ( ASCT ) for multiple myeloma ( MM ) . Forty-eight patients received melphalan 200 mg/m2 i.v . over 2 days and AA 1000 mg i.v . over 7 days in 3 treatment arms : no ATO ( arm 1 ) , ATO 0.15 mg/kg i.v . x 7 days ( arm 2 ) , and ATO 0.25 mg/kg i.v . x 7 days ( arm 3 ) . No dose-limiting toxicity , engraftment failure , or nonrelapse mortality ( NRM ) was seen in the first 100 days post-ASCT . Complete responses ( CR ) were seen in 12 of 48 patients ( 25 % ) , with an overall response rate ( ORR = CR + PR ) of 85 % . Median progression-free survival ( PFS ) was 25 months ; median overall survival ( OS ) has not yet been reached . There was no significant difference in CR , PFS , or OS among the 3 treatment arms , and no adverse effect of ATO on melphalan pharmacokinetics . Addition of ATO + AA to high-dose melphalan is safe and well tolerated as a preparative regimen for MM Purpose : This Phase I study assessed the feasibility of concomitant arsenic trioxide ( ATO ) , ascorbic acid ( AA ) , and bortezomib ( Velcade ™ ) ( AAV ) for patients with relapsed/refractory multiple myeloma . Experimental Design : ATO ( 0.25 mg/kg ) and AA ( 1 g ) were given with an escalating dose of bortezomib ( 1 mg/m2 or 1.3 mg/m2 IV bolus on days 1 and 8 of a 21-day cycle ) . Results : Ten patients ( median age 62 years ) , with a median of 3 prior regimens , were enrolled . Four ( 40 % ) patients achieved clinical benefit , with one patient achieving a durable partial response . No formal DLTs were encountered . Conclusion : AAV combination was feasible and demonstrated some benefits in this heavily pretreated population Arsenic trioxide ( As2O3 ) is a known environmental toxicant and potent chemotherapeutic agent . Significant correlation has been reported between arsenic exposure ( including consumption of arsenic-contaminated water and clinical use of As2O3 ) and dysfunction in the nervous system . In this study , we aim ed to eluci date the effect of resveratrol with neuroprotective activities on As2O3-induced oxidative damage and cerebral cortex injury . Twenty-four healthy Chinese Dragon Li cats of either sex were r and omly divided into four groups : control ( 1 ml/kg physiological saline ) , As2O3 ( 1 mg/kg ) , resveratrol ( 3 mg/kg ) and As2O3 ( 1 mg/kg ) + resveratrol ( 3 mg/kg ) . As2O3+resveratrol-treated group were given resveratrol ( 3 mg/kg ) 1 h before As2O3 ( 1 mg/kg ) administration . Pretreatment with resveratrol upregulated the activities of antioxidant enzymes and attenuated As2O3-induced increases in reactive oxygen species and malondialdehyde production . In addition , resveratrol attenuated the As2O3-induced reduction in the level of reduced glutathione and the ratio of reduced glutathione to oxidised glutathione , and accumulation of arsenic in the cerebral cortex . These findings support neuroprotective effect of resveratrol on As2O3 toxicity in feline brain and provide a better underst and ing of the mechanism that resveratrol modulates As2O3-induced oxidative damage and a stronger rational for clinical use of resveratrol to protect brain against the toxicity of arsenic The therapeutic effect of arsenic trioxide ( As2O3 ) in the treatment of acute promyelocytic leukemia ( APL ) was evaluated among 15 APL patients at relapse after all-trans retinoic acid ( ATRA ) induced and chemotherapy maintained complete remission ( CR ) . As2O3 was administered intravenously at the dose of 10 mg/d . Clinical CR was achieved in nine of 10 ( 90 % ) patients treated with As2O3 alone and in the remaining five patients treated by the combination of As2O3 and low-dose chemotherapeutic drugs or ATRA . During the treatment with As2O3 , there was no bone marrow depression and only limited side effects were encountered . Pharmacokinetic studies , which were performed in eight patients , showed that after a peak level of 5.54 micromol/L to 7.30 micromol/L , plasma arsenic was rapidly eliminated , and the continuous administration of As2O3 did not alter its pharmacokinetic behaviors . In addition , increased amounts of arsenic appeared in the urine , with a daily excretion accounting for approximately 1 % to 8 % of the total daily dose administered . Arsenic contents in hair and nail were increased , and the peak content of arsenic could reach 2.5 to 2.7 microg/g tissue at CR . On the other h and , a decline of the arsenic content in hair and nail was observed after withdrawal of the drug . We conclude that As2O3 treatment is an effective and relatively safe drug in APL patients refractory to ATRA and conventional chemotherapy Purpose : This multicenter , open-label , phase I/II dose escalation study assessed the safety/tolerability and initial efficacy of arsenic trioxide/bortezomib/ascorbic acid ( ABC ) combination therapy in patients with relapsed/refractory multiple myeloma . Experimental Design : Enrolled in six cohorts , patients were given arsenic trioxide ( 0.125 or 0.250 mg/kg ) , bortezomib ( 0.7 , 1.0 , or 1.3 mg/m2 ) , and a fixed dose of ascorbic acid ( 1 g ) i.v . on days 1 , 4 , 8 , and 11 of a 21-day cycle for a maximum of eight cycles . The primary end point was safety/tolerability of the ABC regimen . Results : Twenty-two patients ( median age , 63 years ) were enrolled , having failed a median of 4 ( range , 3 - 9 ) prior therapies . One occurrence of grade 4 thrombocytopenia was observed . One patient had asymptomatic arrhythmia and withdrew from the study . Objective responses were observed in 6 ( 27 % ) patients , including two partial responses and four minor responses . Median progression-free survival was 5 months ( 95 % confidence interval ,
Output:
| Although ATO-based combination treatment was well tolerated by most patients , most trials found that ATO has limited effects on MM patients . |
MS213547 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: STUDY OBJECTIVES To develop a sleepiness scale devoid of semantic or geometric elements . DESIGN Subjects were asked to rank in order 7 cartoon faces representing degrees of sleepiness . We used Thurstone 's scaling procedure to transform these rankings into an interval scale , which allowed us to eliminate 2 of the faces . The remaining 5 faces were ranked again using other subjects . In a validation study , subjects rated their perceived level of sleepiness using our scale and other sleepiness scales . Employed shiftworkers and school-going children used our scale to assess its practical applicability . SETTING S Research and diagnostic sleep laboratories , pre- primary to tertiary institutions , shift-working industry . PARTICIPANTS Ethnically diverse healthy and sleep-disordered adults ( n = 490 ) , and school-going children ( n = 345 ) . MEASUREMENTS AND RESULTS Our faces scale correlated with the Karolinska Sleepiness Scale ( P < .05 ) , the Stanford Sleepiness Scale ( P < .04 ) , and a visual analog scale measuring sleepiness ( P < .0001 ) . Shiftworkers showed a time-on-task effect on the evening shift ( P < .0001 ) and a peak in sleepiness at 4:00 and 5:00 ( P < .0001 ) on the night shift . Eight to 10 year old children appeared sleepier than older children throughout a school day ( P < or = .02 ) and became sleepier as the day progressed ( P < .0001 ) . We confirmed that our scale measures sleepiness , uncontaminated by pain , anger , or happiness . CONCLUSIONS We have devised a sleepiness scale suitable for people too young or insufficiently educated to employ more-conventional scales . We envisage the scale being used for diagnostic , therapeutic , and research purpose In this study , the authors sought to determine the effects of length and clarity on response rates and data quality for two food frequency question naires ( FFQs ) : the newly developed 36-page Diet History Question naire ( DHQ ) , design ed to be cognitively easier for respondents , and a 16-page FFQ developed earlier for the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial . The PLCO Trial is a 23-year r and omized controlled clinical trial begun in 1992 . The sample for this sub study , which was conducted from January to April of 1998 , consisted of 900 control and 450 screened PLCO participants aged 55 - 74 years . Controls received either the DHQ or the PLCO FFQ by mail . Screenees , who had previously completed the PLCO FFQ at baseline , were administered the DHQ . Among controls , the response rate for both FFQs was 82 % . Average amounts of time needed by controls to complete the DHQ and the PLCO FFQ were 68 minutes and 39 minutes , respectively . Percentages of missing or uninterpretable responses were similar between instruments for questions on frequency of intake but were approximately 3 and 9 percentage points lower ( p < or = 0.001 ) in the DHQ for questions on portion size and use of vitamin/mineral supplements , respectively . Among screenees , response rates for the DHQ and the PLCO FFQ were 84 % and 89 % , respectively , and analyses of questions on portion size and supplement use showed few differences . These data indicated that the shorter FFQ was not better from the perspective of response rate and data quality , and that clarity and ease of administration may compensate for question naire length The purpose of this study was to develop and test the Verran and Snyder-Halpern ( VSH ) Sleep Scale , an instrument to subjectively measure sleep characteristics . Four major sleep factors and their associated characteristics were proposed for the Sleep Scale . Subjects completed three r and omly ordered sleep question naires on three consecutive weekday mornings within the first two hours after arising . Scales included the VSH Sleep Scale , a sleep question naire and a sleep log . The VSH Sleep Scale had a reliability coefficient of .82 ( theta ) . Construct validity was examined by factor analysis and correlations between Sleep Scale items and corresponding items on the two other study instruments . Scale validity also was assessed by the known groups method . Beginning support for the validity of the VSH Sleep Scale is provided It seems sensible to tailor treatments of insomnia in relation to the presenting characteristics of the sleeper and of the complaint . This report describes the first study formally to examine the comparative effectiveness of tailored and untailored ( r and omly allocated ) treatments . We developed a question naire to facilitate the design ing of individualized programmes . Results indicated that statistical analysis may underestimate the benefits of tailoring . Measures of clinical ly significant change , however , suggested that tailored treatment though it may be highly effective , is no more so than stimulus control therapy Background : Insomnia is a prevalent health complaint that is often difficult to evaluate reliably . There is an important need for brief and valid assessment tools to assist practitioners in the clinical evaluation of insomnia complaints . Objective : This paper reports on the clinical validation of the Insomnia Severity Index ( ISI ) as a brief screening measure of insomnia and as an outcome measure in treatment research . The psychometric properties ( internal consistency , concurrent validity , factor structure ) of the ISI were evaluated in two sample s of insomnia patients . Methods : The first study examined the internal consistency and concurrent validity of the ISI in 145 patients evaluated for insomnia at a sleep disorders clinic . Data from the ISI were compared to those of a sleep diary measure . In the second study , the concurrent validity of the ISI was evaluated in a sample of 78 older patients who participated in a r and omized-controlled trial of behavioral and pharmacological therapies for insomnia . Change scores on the ISI over time were compared with those obtained from sleep diaries and polysomnography . Comparisons were also made between ISI scores obtained from patients , significant others , and clinicians . Results : The results of Study 1 showed that the ISI has adequate internal consistency and is a reliable self-report measure to evaluate perceived sleep difficulties . The results from Study 2 also indicated that the ISI is a valid and sensitive measure to detect changes in perceived sleep difficulties with treatment . In addition , there is a close convergence between scores obtained from the ISI patient 's version and those from the clinician 's and significant other 's versions . Conclusions : The present findings indicate that the ISI is a reliable and valid instrument to quantify perceived insomnia severity . The ISI is likely to be a clinical ly useful tool as a screening device or as an outcome measure in insomnia treatment research As part of the Women 's Health Initiative Study , the 5-item Women 's Health Initiative Insomnia Rating Scale ( WHIIRS ) was developed . This article summarizes the development of the scale through the use of responses from 66,269 postmenopausal women ( mean age = 62.07 years , SD = 7.41 years ) . All women completed a 10-item question naire concerning sleep . A novel resampling technique was introduced as part of the data analysis . Principal-axes factor analysis without iteration and rotation to a varimax solution was conducted for 120,000 r and om sample s of 1,000 women each . Use of this strategy led to the development of a scale with a highly stable factor structure . Structural equation modeling revealed no major differences in factor structure across age and race-ethnic groups . WHIIRS norms for race-ethnicity and age subgroups are detailed The Sleep Disorders Question naire ( SDQ ) is a 176-item question naire design ed to diagnose the presence of common sleep disorders . This study set out to assess the validity of a Dutch translation of the SDQ . Scores on 145 question naires were analyzed . A cluster analysis of these scores revealed the following clusters : healthy , depression , insomnia , narcolepsy , and apnea . The cluster classification proved correct for 67 % of the subjects , as determined on the basis of polysomnography . These results show that the Dutch SDQ is a reasonably valid instrument for diagnosing sleep disorders
Output:
| Sleep domains have been review ed , and several sleep instruments have been identified . |
MS213548 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Various community-based interventions have been proposed to improve maternity care , but hardly any studies have reported the effect of these measures on maternal mortality . In this study , the efficacy of a maternity-care programme to reduce maternal mortality has been evaluated in the context of a primary health-care project in rural Bangladesh . Trained midwives were posted in villages , and asked to attend as many home-deliveries as possible , detect and manage obstetric complications at onset , and accompany patients requiring referral for higher-level care to the project central maternity clinic . The effect of the programme was evaluated by comparison of direct obstetric maternal mortality ratios between the programme area and a neighbouring control area without midwives . R and om assignment of the intervention was not possible but potentially confounding characteristics , including coverage and use of other health and family planning services , were similar in both areas . Maternal mortality ratios due to obstetric complications were similar in both areas during the 3 years preceding the start of the programme . By contrast , during the following 3 years , the ratio was significantly lower in the programme than in the control area ( 1.4 vs 3.8 per 1000 live births , p = 0.02 ) . The findings suggest that maternal survival can be improved by the posting of midwives at village level , if they are given proper training , means , supervision , and back-up . The inputs for such a programme to succeed and the constraints of its replication on a large scale should not be underestimated BACKGROUND Neonatal deaths in developing countries make the largest contribution to global mortality in children younger than 5 years . 90 % of deliveries in the poorest quintile of households happen at home . We postulated that a community-based participatory intervention could significantly reduce neonatal mortality rates . METHODS We pair-matched 42 geopolitical clusters in Makwanpur district , Nepal , selected 12 pairs r and omly , and r and omly assigned one of each pair to intervention or control . In each intervention cluster ( average population 7000 ) , a female facilitator convened nine women 's group meetings every month . The facilitator supported groups through an action-learning cycle in which they identified local perinatal problems and formulated strategies to address them . We monitored birth outcomes in a cohort of 28?931 women , of whom 8 % joined the groups . The primary outcome was neonatal mortality rate . Other outcomes included stillbirths and maternal deaths , uptake of antenatal and delivery services , home care practice s , infant morbidity , and health-care seeking . Analysis was by intention to treat . The study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N31137309 . FINDINGS From 2001 to 2003 , the neonatal mortality rate was 26.2 per 1000 ( 76 deaths per 2899 livebirths ) in intervention clusters compared with 36.9 per 1000 ( 119 deaths per 3226 livebirths ) in controls ( adjusted odds ratio 0.70 [ 95 % CI 0.53 - 0.94 ] ) . Stillbirth rates were similar in both groups . The maternal mortality ratio was 69 per 100000 ( two deaths per 2899 livebirths ) in intervention clusters compared with 341 per 100000 ( 11 deaths per 3226 livebirths ) in control clusters ( 0.22 [ 0.05 - 0.90 ] ) . Women in intervention clusters were more likely to have antenatal care , institutional delivery , trained birth attendance , and hygienic care than were controls . INTERPRETATION Birth outcomes in a poor rural population improved greatly through a low cost , potentially sustainable and scalable , participatory intervention with women 's groups OBJECTIVES In their efforts to reduce maternal and neonatal morbidity and mortality , many national and international agencies make considerable investments in training traditional birth attendants ( TBAs ) . The value of TBA training is controversial , and plausible arguments are made both for and against . Numerous process evaluations are reported in the literature and the results are mixed , though generally positive . Outcome evaluations , however , are scarce . This article describes an outcome evaluation of TBA training conducted in two districts of Brong-Ahafo Region , Ghana , during 1996 . DESIGN AND METHODS Data from a r and om sample survey of 1961 clients of TBAs were subjected to logistic regression modelling to determine the effect of training on maternal outcomes , controlling for other independent variables . RESULTS Of eight outcomes modelled , three were associated with training and five were not . Three additional outcomes were not modelled , primarily due to low prevalence . CONCLUSIONS Despite some inherent design limitations , this study found that the evidence for a beneficial impact of TBA training was not compelling . Training sponsors should consider alternative health investments and , where TBA training remains the intervention of choice , be realistic about expectations of impact BACKGROUND Effective and scalable community-based strategies are needed for identification and management of serious neonatal illness . METHODS As part of a community-based , cluster-r and omized controlled trial of the impact of a package of maternal-neonatal health care , community health workers ( CHWs ) were trained to conduct household surveillance and to identify and refer sick newborns according to a clinical algorithm . Assessment s of newborns by CHWs at home were linked to hospital-based assessment s by physicians , and factors impacting referral , referral compliance and outcome were evaluated . RESULTS Seventy-three per cent ( 7310/10,006 ) of live-born neonates enrolled in the study were assessed by CHWs at least once ; 54 % were assessed within 2 days of birth , but only 15 % were attended at delivery . Among assessment s for which referral was recommended , compliance was verified in 54 % ( 495/919 ) . Referrals recommended to young neonates 0 - 6 days old were 30 % less likely to be complied with compared to older neonates . Compliance was positively associated with having very severe disease and selected clinical signs , including respiratory rate > or = 70/minute ; weak , abnormal or absent cry ; lethargic or less than normal movement ; and feeding problem . Among 239 neonates who died , only 38 % were assessed by a CHW before death . CONCLUSIONS Despite rigorous programmatic effort , reaching neonates within the first 2 days after birth remained a challenge , and parental compliance with referral recommendation was limited , particularly among young neonates . To optimize potential impact , community postnatal surveillance must be coupled with skilled attendance at delivery , and /or a worker skilled in recognition of neonatal illness must be placed in close proximity to the community to allow for rapid case management to avert early deaths OBJECTIVE : We found a high burden of morbidities in a cohort of neonates observed in rural Gadchiroli , India . We hypothesised that interventions would reduce the incidence of neonatal morbidities , including the seasonal increase observed in many of them . This article reports the effect of home-based neonatal care on neonatal morbidities in the intervention arm of the field trial by comparing the early vs late periods , and the possible explanation for this effect . METHODS : During 3 years ( 1995 to 1998 ) , trained village-health-workers ( VHWs ) in 39 villages prospect ively collected data by making home visits during pregnancy , home-delivery and during neonatal period . We estimated the incidence and burden of neonatal morbidities over the 3 years from these data . In the first year , the VHWs made home visits only to observe . From the second year , they assisted mothers in neonatal care and managed the sick neonates at home . Health education of mothers and family members , individually and in group , was added in the third year . We measured the coverage of interventions over the 3 years and evaluated maternal knowledge and practice s on 21 indicators in the third year . The effect on 17 morbidities was estimated by comparing the incidence in the first year with the third year . RESULTS : The VHWs observed 763 neonates in the first year , 685 in the second and 913 in the third year . The change in the percent incidence of morbidities was ( i ) infections , from 61.6 to 27.5 ( −55 % ; p<0.001 ) , ( ii ) care-related morbidities ( asphyxia , hypothermia , feeding problems ) from 48.2 to 26.3 ( −45 % ; p<0.001 ) ; ( iii ) low birth weight from 41.9 to 35.2 ( −16 % ; p<0.05 ) ; ( iv ) preterm birth and congenital anomalies remained unchanged . The mean number of morbidities/100 neonates in the 3 years was 228 , 170 and 115 ( a reduction of 49.6 % ; p<0.001 ) . These reductions accompanied an increasing percent score of interventions during 3 years : 37.9 , 58.4 and 81.3 , thus showing a dose – response relationship . In the third year , the proportion of correct maternal knowledge was 78.7 % and behaviours was 69.7 % . The significant seasonal increase earlier observed in the incidence of five morbidities reduced in the third year . CONCLUSION : The home-based care and health education reduced the incidence and burden of neonatal morbidities by nearly half . The effect was broad , but was especially pronounced on infections , care-related morbidities and on the seasonal increase in morbidities BACKGROUND In rural India , most births take place in the home , where high-risk care practice s are common . We developed an intervention of behaviour change management , with a focus on prevention of hypothermia , aim ed at modifying practice s and reducing neonatal mortality . METHODS We did a cluster-r and omised controlled efficacy trial in Shivgarh , a rural area in Uttar Pradesh . 39 village administrative units ( population 104,123 ) were allocated to one of three groups : a control group , which received the usual services of governmental and non-governmental organisations in the area ; an intervention group , which received a preventive package of interventions for essential newborn care ( birth preparedness , clean delivery and cord care , thermal care [ including skin-to-skin care ] , breastfeeding promotion , and danger sign recognition ) ; or another intervention group , which received the package of essential newborn care plus use of a liquid crystal hypothermia indicator ( ThermoSpot ) . In the intervention clusters , community health workers delivered the packages via collective meetings and two antenatal and two postnatal household visitations . Outcome measures included changes in newborn-care practice s and neonatal mortality rate compared with the control group . Analysis was by intention to treat . This study is registered as International St and ard R and omised Control Trial , number NCT00198653 . FINDINGS Improvements in birth preparedness , hygienic delivery , thermal care ( including skin-to-skin care ) , umbilical cord care , skin care , and breastfeeding were seen in intervention arms . There was little change in care-seeking . Compared with controls , neonatal mortality rate was reduced by 54 % in the essential newborn-care intervention ( rate ratio 0.46 [ 95 % CI 0.35 - 0.60 ] , p<0.0001 ) and by 52 % in the essential newborn care plus ThermoSpot arm ( 0.48 [ 95 % CI 0.35 - 0.66 ] , p<0.0001 ) . INTERPRETATION A socioculturally context ualised , community-based intervention , targeted at high-risk newborn-care practice s , can lead to substantial behavioural modification and reduction in neonatal mortality . This approach can be applied to behaviour change along the continuum of care , harmonise vertical interventions , and build community capacity for sustained development . FUNDING USAID and Save the Children-US through a grant from the Bill & Melinda Gates Foundation This analysis identifies salient features of team management that were critical to the efficiency of program implementation and the effectiveness of behavior change management to promote essential newborn care practice s in Uttar Pradesh , India . In May 2003 , the Johns Hopkins Bloomberg School of Public Health and King George Medical University initiated a cluster-r and omized , controlled neonatal health research program . In less than 2 years , the trial demonstrated rapid adoption of several evidence -based newborn care practice s and a substantial reduction in neonatal mortality in intervention clusters . Existing literature involving research program management in re source -constrained areas of developing countries is limited and fails to provide models for team organization and empowerment . The neonatal research project examined in this paper developed a unique management strategy that provides an effective blueprint for future projects . Transferable learning points from the project include emphasizing a common vision , utilizing a live-in field site office , prioritizing character and potential in the hiring process , implementing a learning-by-doing training program , creating tiers of staff recognition , encouraging staff autonomy , ensuring a broad staff knowledge base to seamlessly h and le absences , and maintaining the flexibility to change partnerships or strategies OBJECTIVE : To assess the ability of midwives to interpret antenatal cards and partograms correctly following completion of the Maternal Care Manual of the Perinatal Education Programme . STUDY DESIGN : We conducted a prospect i ve , controlled trial in a study town and two control towns in the Eastern Cape Province of South Africa . All 93 midwives caring for pregnant women in the three towns were included in the study . Sample s were compared using the two-tailed Student ’s t-test . RESULTS : The marks achieved by the study group for questions from the antenatal card and the partogram improved by 33.0 % ( p < 0.001 ) and 17.5 % ( p = 0.001 ) , respectively . No changes were observed in the
Output:
| Innovative community-based strategies combined with health systems strengthening may improve childbirth care for the rural poor , help reduce gross inequities in maternal and newborn survival and stillbirth rates , and provide an effective transition to higher coverage for facility births |
MS213549 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Effects of diet on blood lipids are best known in white men , and effects of type of carbohydrate on triacylglycerol concentrations are not well defined . OBJECTIVE Our goal was to determine the effects of diet on plasma lipids , focusing on subgroups by sex , race , and baseline lipid concentrations . DESIGN This was a r and omized controlled outpatient feeding trial conducted in 4 field centers . The subjects were 436 participants of the Dietary Approaches to Stop Hypertension ( DASH ) Trial [ mean age : 44.6 y ; 60 % African American ; baseline total cholesterol : < or = 6.7 mmol/L ( < or = 260 mg/dL ) ] . The intervention consisted of 8 wk of a control diet , a diet increased in fruit and vegetables , or a diet increased in fruit , vegetables , and low-fat dairy products and reduced in saturated fat , total fat , and cholesterol ( DASH diet ) , during which time subjects remained weight stable . The main outcome measures were fasting total cholesterol , LDL cholesterol , HDL cholesterol , and triacylglycerol . RESULTS Relative to the control diet , the DASH diet result ed in lower total ( -0.35 mmol/L , or -13.7 mg/dL ) , LDL- ( -0.28 mmol/L , or -10.7 mg/dL ) , and HDL- ( -0.09 mmol/L , or -3.7 mg/dL ) cholesterol concentrations ( all P < 0.0001 ) , without significant effects on triacylglycerol . The net reductions in total and LDL cholesterol in men were greater than those in women by 0.27 mmol/L , or 10.3 mg/dL ( P = 0.052 ) , and by 0.29 mmol/L , or 11.2 mg/dL ( P < 0.02 ) , respectively . Changes in lipids did not differ significantly by race or baseline lipid concentrations , except for HDL , which decreased more in participants with higher baseline HDL-cholesterol concentrations than in those with lower baseline HDL-cholesterol concentrations . The fruit and vegetable diet produced few significant lipid changes . CONCLUSIONS The DASH diet is likely to reduce coronary heart disease risk . The possible opposing effect on coronary heart disease risk of HDL reduction needs further study Objectives To estimate 10 year decline in cognitive function from longitudinal data in a middle aged cohort and to examine whether age cohorts can be compared with cross sectional data to infer the effect of age on cognitive decline . Design Prospect i ve cohort study . At study inception in 1985 - 8 , there were 10 308 participants , representing a recruitment rate of 73 % . Setting Civil service departments in London , United Kingdom . Participants 5198 men and 2192 women , aged 45 - 70 at the beginning of cognitive testing in 1997 - 9 . Main outcome measure Tests of memory , reasoning , vocabulary , and phonemic and semantic fluency , assessed three times over 10 years . Results All cognitive scores , except vocabulary , declined in all five age categories ( age 45 - 49 , 50 - 54 , 55 - 59 , 60 - 64 , and 65 - 70 at baseline ) , with evidence of faster decline in older people . In men , the 10 year decline , shown as change/range of test × 100 , in reasoning was −3.6 % ( 95 % confidence interval −4.1 % to −3.0 % ) in those aged 45 - 49 at baseline and −9.6 % ( −10.6 % to −8.6 % ) in those aged 65 - 70 . In women , the corresponding decline was −3.6 % ( −4.6 % to −2.7 % ) and −7.4 % ( −9.1 % to −5.7 % ) . Comparisons of longitudinal and cross sectional effects of age suggest that the latter overestimate decline in women because of cohort differences in education . For example , in women aged 45 - 49 the longitudinal analysis showed reasoning to have declined by −3.6 % ( −4.5 % to −2.8 % ) but the cross sectional effects suggested a decline of −11.4 % ( −14.0 % to −8.9 % ) . Conclusions Cognitive decline is already evident in middle age ( age 45 - 49 ) Depressive symptoms may increase the risk of progressing from mild cognitive impairment ( MCI ) to dementia . Consumption of n-3 PUFA may alleviate both cognitive decline and depression . The aim of the present study was to investigate the benefits of supplementing a diet with n-3 PUFA , DHA and EPA , for depressive symptoms , quality of life ( QOL ) and cognition in elderly people with MCI . We conducted a 6-month double-blind , r and omised controlled trial . A total of fifty people aged > 65 years with MCI were allocated to receive a supplement rich in EPA ( 1·67 g EPA + 0·16 g DHA/d ; n 17 ) , DHA ( 1·55 g DHA + 0·40 g EPA/d ; n 18 ) or the n-6 PUFA linoleic acid ( LA ; 2·2 g/d ; n 15 ) . Treatment allocation was by minimisation based on age , sex and depressive symptoms ( Geriatric Depression Scale , GDS ) . Physiological and cognitive assessment s , question naires and fatty acid composition of erythrocytes were obtained at baseline and 6 months ( completers : n 40 ; EPA n 13 , DHA n 16 , LA n 11 ) . Compared with the LA group , GDS scores improved in the EPA ( P=0·04 ) and DHA ( P=0·01 ) groups and verbal fluency ( Initial Letter Fluency ) in the DHA group ( P=0·04 ) . Improved GDS scores were correlated with increased DHA plus EPA ( r 0·39 , P=0·02 ) . Improved self-reported physical health was associated with increased DHA . There were no treatment effects on other cognitive or QOL parameters . Increased intakes of DHA and EPA benefited mental health in older people with MCI . Increasing n-3 PUFA intakes may reduce depressive symptoms and the risk of progressing to dementia . This needs to be investigated in larger , depressed sample s with MCI BACKGROUND Docosahexaenoic acid ( DHA ) is important for brain function , and its status is dependent on dietary intakes . Therefore , individuals who consume diets low in omega-3 ( n-3 ) polyunsaturated fatty acids may cognitively benefit from DHA supplementation . Sex and apolipoprotein E genotype ( APOE ) affect cognition and may modulate the response to DHA supplementation . OBJECTIVES We investigated whether a DHA supplement improves cognitive performance in healthy young adults and whether sex and APOE modulate the response . DESIGN Healthy adults ( n = 176 ; age range : 18 - 45 y ; nonsmoking and with a low intake of DHA ) completed a 6-mo r and omized , placebo-controlled , double-blind intervention in which they consumed 1.16 g DHA/d or a placebo . Cognitive performance was assessed by using a computerized cognitive test battery . For all tests , z scores were calculated and clustered into cognitive domains as follows : episodic and working memory , attention , reaction time ( RT ) of episodic and working memory , and attention and processing speed . ANCOVA was conducted with sex and APOE as independent variables . RESULTS RTs of episodic and working memory improved with DHA compared with placebo [ mean difference ( 95 % CI ) : -0.18 SD ( -0.33 , -0.03 SD ) ( P = 0.02 ) and -0.36 SD ( -0.58 , -0.14 SD ) ( P = 0.002 ) , respectively ] . Sex × treatment interactions occurred for episodic memory ( P = 0.006 ) and the RT of working memory ( P = 0.03 ) . Compared with the placebo , DHA improved episodic memory in women [ 0.28 SD ( 0.08 , 0.48 SD ) ; P = 0.006 ] and RTs of working memory in men [ -0.60 SD ( -0.95 , -0.25 SD ) ; P = 0.001 ] . APOE did not affect cognitive function , but there were some indications of APOE × sex × treatment interactions . CONCLUSIONS DHA supplementation improved memory and the RT of memory in healthy , young adults whose habitual diets were low in DHA . The response was modulated by sex . This trial was registered at the New Zeal and Clinical Trials Registry ( http://www.anzctr.org.au/default.aspx ) as ACTRN12610000212055 Studies in rodents indicate that diets deficient in omega-3 polyunsaturated fatty acids ( n–3 PUFA ) lower dopamine neurotransmission as measured by striatal vesicular monoamine transporter type 2 ( VMAT2 ) density and amphetamine-induced dopamine release . This suggests that dietary supplementation with fish oil might increase VMAT2 availability , enhance dopamine storage and release , and improve dopamine-dependent cognitive functions such as working memory . To investigate this mechanism in humans , positron emission tomography ( PET ) was used to measure VMAT2 availability pre- and post-supplementation of n–3 PUFA in healthy individuals . Healthy young adult subjects were scanned with PET using [11C]-(+)-α-dihydrotetrabenzine ( DTBZ ) before and after six months of n–3 PUFA supplementation ( Lovaza , 2 g/day containing docosahexaenonic acid , DHA 750 mg/d and eicosapentaenoic acid , EPA 930 mg/d ) . In addition , subjects underwent a working memory task ( n-back ) and red blood cell membrane ( RBC ) fatty acid composition analysis pre- and post-supplementation . RBC analysis showed a significant increase in both DHA and EPA post-supplementation . In contrast , no significant change in [11C]DTBZ binding potential ( BPND ) in striatum and its subdivisions were observed after supplementation with n–3 PUFA . No correlation was evident between n–3 PUFA induced change in RBC DHA or EPA levels and change in [11C]DTBZ BPND in striatal subdivisions . However , pre-supplementation RBC DHA levels was predictive of baseline performance ( i.e. , adjusted hit rate , AHR on 3-back ) on the n-back task ( y = 0.19 + 0.07 , r2 = 0.55 , p = 0.009 ) . In addition , subjects AHR performance improved on 3-back post-supplementation ( pre 0.65±0.27 , post 0.80±0.15 , p = 0.04 ) . The correlation between n-back performance , and DHA levels are consistent with reports in which higher DHA levels is related to improved cognitive performance . However , the lack of change in [11C]DBTZ BPND indicates that striatal VMAT2 regulation is not the mechanism of action by which n–3 PUFA improves cognitive performance Abstract . The effects of capsules containing 60 mg of a st and ardised extract of Ginkgo biloba ( GK501 ) and 100 mg of a st and ardised extract of Panax ginseng ( G115 ) on various aspects of cognitive function were assessed in healthy middle-aged volunteers . A double blind , placebo controlled , 14 week , parallel group , repeated assessment , multi-centre trial of two dosing regimens , 160 mg b.i.d . and 320 mg o.d . was conducted . Two hundred and fifty-six healthy middle-aged volunteers successfully completed the study . On various study days ( weeks 0 , 4 , 8 , 12 and 14 ) the volunteers performed a selection of tests of attention and memory from the Cognitive Drug Research computerised cognitive assessment system prior to morning dosing and again , at 1 , 3 and 6 h later . The volunteers also completed question naires about mood states , quality of life and sleep quality . The Ginkgo/ginseng combination was found significantly to improve an Index of Memory Quality , supporting a previous finding with the compound . This effect represented an average improvement of 7.5 % and reflected improvements to a number of different aspects of memory , including working and long-term memory . This enhancement to memory was seen throughout the 12-week dosing period and also after a 2-week washout . This represents the first substantial demonstration of improvements to the memory of healthy middle-aged volunteers produced by a phytopharmaceutical The omega-3 fatty acid docosahexaenoic acid ( DHA ) is essential for nervous system and retinal development and there is evidence to suggest that DHA deficiencies increase with normal aging . A triple-blind placebo-controlled r and omized repeated- measures trial was conducted with 74 healthy participants , aged 45 - 77 years . Cognitive and visual acuity measures and plasma levels of DHA were determined at baseline and after 90 days of administration of either HiDHA ( ® ) ( Clover Corp. , Sydney , NSW , Australia : 1000 mg of tuna oil ; comprising 252 mg DHA , 60 mg EPA and 10 mg vitamin E ) or placebo ( 100
Output:
| This will increase the generalisability of trial results to the general population . |
MS213550 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Purpose Whilst psychotic experiences are associated with suicidal behaviour in a number of studies the value of psychotic experiences for the prediction of suicidal behaviour and the role of depressive symptoms in this relationship is not clear . We examined the association between psychotic experiences and subsequent suicidal behaviour and examine the role of depressive symptoms in this relationship . Methods Psychotic experiences and depressive symptoms at age 12 and 16 years , and suicidal behaviour at age 16 years were assessed in participants ( prospect i ve analysis n = 3171 ; cross-sectional analysis n = 3952 ) from a population -based cohort . Results Psychotic experiences ( OR 1.75 95 % CI 1.20 , 2.54 ) and depression ( OR 3.97 95 % CI 2.56 , 6.15 ) at 12 years were independently associated with suicidal behaviour at 16 years after adjustment for confounding . There was no evidence that the relationship between psychotic experiences and suicidal behaviour was stronger in participants who were also depressive . A ROC analysis showed that adding information on psychotic experiences to measures of depressive symptoms had hardly any effect on improving prediction of suicidal behaviour ( AUC increased from 0.64 to 0.65 ) . Whereas adding a measure of depressive symptoms to the measure of psychotic experiences improved prediction substantially ( AUC 0.56–0.65 ) . Conclusions Psychotic experiences and depression are independently associated with suicidal behaviour although the association with depression is substantially stronger . Psychotic experiences alone are not a strong predictor of later suicidal behaviour and add little to predicting the risk of suicidal behaviour over and above the information provided by depressive symptoms Little is known about the occurrence and predictors of the psychosis spectrum in large non- clinical community sample s of U.S. youths . We aim ed to bridge this gap through assessment of psychosis spectrum symptoms in the Philadelphia Neurodevelopmental Cohort , a collaborative investigation of clinical and neurobehavioral phenotypes in a prospect ively accrued cohort of youths , funded by the National Institute of Mental Health . Youths ( age 11 - 21 ; N=7,054 ) and collateral informants ( caregiver/legal guardian ) were recruited through the Children 's Hospital of Philadelphia and administered structured screens of psychosis spectrum symptoms , other major psychopathology domains , and substance use . Youths were also administered a computerized neurocognitive battery assessing five neurobehavioral domains . Predictors of psychosis spectrum status in physically healthy participants ( N=4,848 ) were examined using logistic regression . Among medically healthy youths , 3.7 % reported threshold psychotic symptoms ( delusions and /or hallucinations ) . An additional 12.3 % reported significant sub-psychotic positive symptoms , with odd/unusual thoughts and auditory perceptions , followed by reality confusion , being the most discriminating and widely endorsed attenuated symptoms . A minority of youths ( 2.3 % ) endorsed sub clinical negative/disorganized symptoms in the absence of positive symptoms . Caregivers reported lower symptom levels than their children . Male gender , younger age , and non-European American ethnicity were significant predictors of spectrum status . Youths with spectrum symptoms had reduced accuracy across neurocognitive domains , reduced global functioning , and increased odds of depression , anxiety , behavioral disorders , substance use and suicidal ideation . These findings have public health relevance for prevention and early intervention IMPORTANCE Up to 1 million persons die by suicide annually . However , a lack of risk markers makes suicide risk assessment one of the most difficult areas of clinical practice . OBJECTIVE To assess psychotic symptoms ( attenuated or frank ) as a clinical marker of risk for suicide attempt . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 1112 school-based adolescents ( aged 13 - 16 years ) , assessed at baseline and at 3 and 12 months for self-reported psychopathology , psychotic symptoms , and suicide attempts . MAIN OUTCOMES AND MEASURES Suicide attempts at the 3- and 12-month follow-up and acute suicide attempts ( defined as those occurring in the 2 weeks before an assessment ) . RESULTS Of the total sample , 7 % reported psychotic symptoms at baseline . Of that sub sample , 7 % reported a suicide attempt by the 3-month follow-up compared with 1 % of the rest of the sample ( odds ratio [ OR ] , 10.01 ; 95 % CI , 2.24 - 45.49 ) , and 20 % reported a suicide attempt by the 12-month follow-up compared with 2.5 % of the rest of the sample ( OR , 11.27 ; 95 % CI , 4.44 - 28.62 ) . Among adolescents with baseline psychopathology who reported psychotic symptoms , 14 % reported a suicide attempt by 3 months ( OR , 17.91 ; 95 % CI , 3.61 - 88.82 ) and 34 % reported a suicide attempt by 12 months ( OR , 32.67 ; 95 % CI , 10.42 - 102.41 ) . Adolescents with psychopathology who reported psychotic symptoms had a nearly 70-fold increased odds of acute suicide attempts ( OR , 67.50 ; 95 % CI , 11.41 - 399.21 ) . Differences were not explained by nonpsychotic psychiatric symptom burden , multimorbidity , or substance use . In a causative model , the population -attributable fraction of suicide attempts would be 56 % to 75 % for psychotic symptoms . CONCLUSIONS AND RELEVANCE Adolescents with psychopathology who report psychotic symptoms are at clinical high risk for suicide attempts . More careful clinical assessment of psychotic symptoms ( attenuated or frank ) in mental health services and better underst and ing of their pathological significance are urgently needed BACKGROUND Non-suicidal self-injury ( NSSI ) is the deliberate and direct injuring of body tissue without suicidal intent for purpose s not socially sanctioned . Few studies have examined the correlates of NSSI among young adults . This study aim ed to identify predictors of lifetime and past-year NSSI , and describe motives for NSSI and disclosure of NSSI to others . METHOD Interviews were conducted annually with 1081 students enrolled in the College Life Study , a prospect i ve longitudinal study conducted at a large public mid-Atlantic university . NSSI characteristics were assessed at Year 4 . Demographic and predictor variables were assessed during Years 1 to 4 . Multivariate logistic regression models were used to identify correlates of lifetime NSSI and predictors of past-year NSSI . RESULTS The prevalence of past-year and lifetime NSSI was 2 % and 7 % respectively ( > 70 % were female for both lifetime and past-year NSSI ) . Seven percent of NSSI cases self-injured once , whereas almost half self-injured six or more times . Independent predictors of past-year NSSI were maternal depression , non-heterosexual orientation , affective dysregulation and depression . Independent predictors of lifetime NSSI were depression , non-heterosexual orientation , paternal depression and female sex . One in six participants with NSSI had attempted suicide by young adulthood . The three most commonly reported motives for NSSI were mental distress , coping and situational stressors . Most ( 89 % ) told someone about their NSSI , most commonly a friend ( 68 % ) . CONCLUSIONS This study identified unique predictors of NSSI , which should help to eluci date its etiology and has implication s for early identification and interventions CONTEXT It has been reported that childhood psychotic symptoms are common in the general population and may signal neurodevelopmental processes that lead to schizophrenia . However , it is not clear whether these symptoms are associated with the same extensive risk factors established for adult schizophrenia . OBJECTIVE To examine the construct validity of children 's self-reported psychotic symptoms by testing whether these symptoms share the risk factors and clinical features of adult schizophrenia . DESIGN Prospect i ve , longitudinal cohort study of a nationally representative birth cohort in Great Britain . PARTICIPANTS A total of 2232 twelve-year-old children followed up since age 5 years ( retention , 96 % ) . Main Outcome Measure Children 's self-reported hallucinations and delusions . RESULTS Children 's psychotic symptoms are familial and heritable and are associated with social risk factors ( eg , urbanicity ) ; cognitive impairments at age 5 ; home-rearing risk factors ( eg , maternal expressed emotion ) ; behavioral , emotional , and educational problems at age 5 ; and comorbid conditions , including self-harm . CONCLUSIONS The results provide a comprehensive picture of the construct validity of children 's self-reported psychotic symptoms . For research ers , the findings indicate that children who have psychotic symptoms can be recruited for neuroscience research to determine the pathogenesis of schizophrenia . For clinicians , the findings indicate that psychotic symptoms in childhood are often a marker of an impaired developmental process and should be actively assessed BACKGROUND Childhood psychotic symptoms have been used as a sub clinical phenotype of schizophrenia in etiological research and as a target for preventative interventions . However , recent studies have cast doubt on the specificity of these symptoms for schizophrenia , suggesting alternative outcomes such as anxiety and depression . Using a prospect i ve longitudinal birth cohort we investigated whether childhood psychotic symptoms predicted a diagnosis of schizophrenia or other psychiatric disorders by 38 years of age . METHOD Participants were drawn from a birth cohort of 1037 children from Dunedin , New Zeal and , who were followed prospect ively to 38 years of age ( 96 % retention rate ) . Structured clinical interviews were administered at age 11 to assess psychotic symptoms and study members underwent psychiatric assessment s at ages 18 , 21 , 26 , 32 and 38 to obtain past-year DSM-III-R/IV diagnoses and self-reports of attempted suicides since adolescence . RESULTS Psychotic symptoms at age 11 predicted elevated rates of research diagnoses of schizophrenia and posttraumatic stress disorder ( PTSD ) and also suicide attempts by age 38 , even when controlling for gender , social class and childhood psychopathology . No significant associations were found for persistent anxiety , persistent depression , mania or persistent substance dependence . Very few of the children presenting with age-11 psychotic symptoms were free from disorder by age 38 . CONCLUSIONS Childhood psychotic symptoms were not specific to a diagnosis of schizophrenia in adulthood and thus future studies of early symptoms should be cautious in extrapolating findings only to this clinical disorder . However , these symptoms may be useful as a marker of adult mental health problems more broadly CONTEXT It has been suggested that patients with major depressive disorder ( MDD ) who display pretreatment features suggestive of bipolar disorder or bipolar spectrum features might have poorer treatment outcomes . OBJECTIVE To assess the association between bipolar spectrum features and antidepressant treatment outcome in MDD . DESIGN Open treatment followed by sequential r and omized controlled trials . SETTING Primary and specialty psychiatric outpatient centers in the United States . PARTICIPANTS Male and female out patients aged 18 to 75 years with a DSM-IV diagnosis of nonpsychotic MDD who participated in the Sequenced Treatment Alternatives to Relieve Depression ( STAR*D ) study . INTERVENTIONS Open treatment with citalopram followed by up to 3 sequential next-step treatments . MAIN OUTCOME MEASURES Number of treatment levels required to reach protocol -defined remission , as well as failure to return for the postbaseline visit , loss to follow-up , and psychiatric adverse events . For this secondary analysis , putative bipolar spectrum features , including items on the mania and psychosis subscales of the Psychiatric Diagnosis Screening Question naire , were examined for association with treatment outcomes . RESULTS Of the 4041 subjects who entered the study , 1198 ( 30.0 % ) endorsed at least 1 item on the psychosis scale and 1524 ( 38.1 % ) described at least 1 recent maniclike/hypomaniclike symptom . Irritability and psychoticlike symptoms at entry were significantly associated with poorer outcomes across up to 4 treatment levels , as were shorter episodes and some neurovegetative symptoms of depression . However , other indicators of bipolar diathesis including recent maniclike symptoms and family history of bipolar disorder as well as summary measures of bipolar spectrum features were not associated with treatment resistance . CONCLUSION Self-reported psychoticlike symptoms were common in a community sample of out patients with MDD and strongly associated with poorer outcomes . Overall , the data do not support the hypothesis that unrecognized bipolar spectrum illness contributes substantially to antidepressant treatment resistance
Output:
| Subanalyses showed that PE were associated with self-harm , suicidal ideation as well as suicidal attempts .
All studies had scope for considerable residual confounding ; effect sizes adjusted for depression were significantly smaller than effect sizes unadjusted for depression .
PE are associated with self-injurious behaviour , suggesting they have potential as passive markers of suicidality .
Given evidence that PE represent an indicator of severity of non-psychotic psychopathology , the association between PE and self-injurious behaviour probably reflects a greater likelihood of self-injurious behaviour in more severe states of mental distress |
MS213551 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials PURPOSE To evaluate the efficacy and safety of high-dose , hypofractionated proton beam therapy for hepatocellular carcinoma ( HCC ) and intrahepatic cholangiocarcinoma ( ICC ) . MATERIAL S AND METHODS In this single-arm , phase II , multi-institutional study , 92 patients with biopsy-confirmed HCC or ICC , determined to be unresectable by multidisciplinary review , with a Child-Turcotte-Pugh score ( CTP ) of A or B , ECOG performance status of 0 to 2 , no extrahepatic disease , and no prior radiation received 15 fractions of proton therapy to a maximum total dose of 67.5 Gy equivalent . Sample size was calculated to demonstrate > 80 % local control ( LC ) defined by Response Evaluation Criteria in Solid Tumors ( RECIST ) 1.0 criteria at 2 years for HCC patients , with the parallel goal of obtaining acceptable precision for estimating outcomes for ICC . RESULTS Eighty-three patients were evaluable : 44 with HCC , 37 with ICC , and two with mixed HCC/ICC . The CTP score was A for 79.5 % of patients and B for 15.7 % ; 4.8 % of patients had no cirrhosis . Prior treatment had been given to 31.8 % of HCC patients and 61.5 % of ICC patients . The median maximum dimension was 5.0 cm ( range , 1.9 to 12.0 cm ) for HCC patients and 6.0 cm ( range , 2.2 to 10.9 cm ) for ICC patients . Multiple tumors were present in 27.3 % of HCC patients and in 12.8 % of ICC patients . Tumor vascular thrombosis was present in 29.5 % of HCC patients and in 28.2 % of ICC patients . The median dose delivered to both HCC and ICC patients was 58.0 Gy . With a median follow-up among survivors of 19.5 months , the LC rate at 2 years was 94.8 % for HCC and 94.1 % for ICC . The overall survival rate at 2 years was 63.2 % for HCC and 46.5 % ICC . CONCLUSION High-dose hypofractionated proton therapy demonstrated high LC rates for HCC and ICC safely , supporting ongoing phase III trials of radiation in HCC and ICC Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must be done cautiously . Pooling exercises do not replace well design ed prospect i ve clinical trials . Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful . PURPOSE To describe results of a planned interim analysis of a prospect i ve , r and omized clinical trial developed to compare treatment outcomes among patients with newly diagnosed hepatocellular carcinoma ( HCC ) . METHODS AND MATERIAL S Eligible subjects had either clinical or pathologic diagnosis of HCC and met either Milan or San Francisco transplant criteria . Patients were r and omly assigned to transarterial chemoembolization ( TACE ) or to proton beam radiation therapy . Patients r and omized to TACE received at least 1 TACE with additional TACE for persistent disease . Proton beam radiation therapy was delivered to all areas of gross disease to a total dose of 70.2 Gy in 15 daily fractions over 3 weeks . The primary endpoint was progression-free survival , with secondary endpoints of overall survival , local tumor control , and treatment-related toxicities as represented by posttreatment days of hospitalization . RESULTS At the time of this analysis 69 subjects were available for analysis . Of these , 36 were r and omized to TACE and 33 to proton . Total days of hospitalization within 30 days of TACE/proton was 166 and 24 days , respectively ( P<.001 ) . Ten TACE and 12 proton patients underwent liver transplantation after treatment . Viable tumor identified in the explanted livers after TACE/proton averaged 2.4 and 0.9 cm , respectively . Pathologic complete response after TACE/proton was 10%/25 % ( P=.38 ) . The 2-year overall survival for all patients was 59 % , with no difference between treatment groups . Median survival time was 30 months ( 95 % confidence interval 20.7 - 39.3 months ) . There was a trend toward improved 2-year local tumor control ( 88 % vs 45 % , P=.06 ) and progression-free survival ( 48 % vs 31 % , P=.06 ) favoring the proton beam treatment group . CONCLUSIONS This interim analysis indicates similar overall survival rates for proton beam radiation therapy and TACE . There is a trend toward improved local tumor control and progression-free survival with proton beam . There are significantly fewer hospitalization days after proton treatment , which may indicate reduced toxicity with proton beam therapy 4024 Background : Proton beam radiotherapy ( PRT ) has an excellent depth-dose profile that can deliver high dose to the liver tumor without debilitating liver function compared to photon beam radiotherapy . It is reasonable to evaluate the safety and efficacy of PRT prospect ively for hepatocellular carcinoma ( HCC ) . METHODS Eligibility criteria for this study were : solitary HCC ; neither surgery nor local ablation therapy were indicated ; no ascites ; age ≥20 years ; Zubord performance status is 0∼2 ; no serious co-morbidities other than liver cirrhosis ; written informed consent . Tumor close to the stomach or intestinal loop was not considered as a subject for this study . Clinical target volume ( CTV ) was defined as gross tumor volume plus 5 mm of lateral and cranio-caudal margin . PRT administering 76 GyE/20 fractions/5 weeks to the CTV was done using respiration-gated irradiation system ( ReGIS ) with 150∼190 MeV proton beam . Relative biological effectiveness of our proton beam was defined as 1.1 . No patients received transarterial chemoembolization or local ablation in combination with PRT . RESULTS Thirty patients were enrolled between May 1999 and Feb. 2003 . There were 20 male and 10 female with a median age of 70 years ( range : 48∼87 years ) . Maximum tumor diameter ranged from 25 ∼ 82 mm ( median 45 mm ) . All patients had liver cirrhosis of which the degree was Child class A in 9 , B in 19 , and C in 2 . Acute reactions of PRT were well tolerated , and PRT were completed as planned in all patients . After a median follow-up period of 31 months ( 14∼54 months ) , only 1 patient experienced tumor recurrence within the CTV and 2-year actuarial local control rate was as 96 % ( 95 % confidence interval : 88%∼100 % ) . Actuarial overall survival rate at 2 years was 64 % ( 46∼83 % ) . Pretreatment liver function that was evaluated with indocyanin green clearance at 15 minutes ( ICG 15 ) , and liver volume that received 30 GyE or more ( V30 ) significantly correlated with overall survival . CONCLUSIONS Since PRT showed minimal acute toxicity and excellent tumor control within CTV , it is expected as one of the convincing non-surgical treatment options for HCC . ICG 15 and V30 were considered as useful indicators of patient prognosis . No significant financial relationships to disclose This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence The purpose of this study was to evaluate the clinical efficacy , toxicity and adverse effects of stereotactic body radiotherapy ( SBRT ) combined with transarterial chemoembolization ( TACE ) in patients with advanced hepatocellular carcinoma ( HCC ) with portal vein tumor thrombosis ( PVTT ) . A total of 101 patients diagnosed with primary HCC with PVTT were enrolled in this study and were r and omly divided into three groups as follows : group A , 34 patients treated with γ-SBRT followed by TACE ; group B , 37 patients treated with TACE followed by γ-SBRT ; and group C , 30 patients treated with γ-SBRT alone . The effective response rate for the entire patient sample was 87.1 % ( 88/101 ) following a 3-month treatment . The differences in the response rate , survival rate , α-fetoprotein level restoration rate and rate of improvement of abdominal distention and discomfort between groups A and B were not statistically significant ( P>0.05 ) . However , the rates of groups A and B were higher compared to those of group C ( P<0.05 ) . The exacerbation rate of liver function in group A was lower compared to that in group B ( P<0.05 ) , although it exhibited no statistically significant difference from that in group C ( P>0.05 ) . No severe radiation-related complications were reported during the follow-up period . The combination of γ-SBRT and TACE was shown to be a relatively effective local treatment for primary HCC patients with PVTT . Compared to γ-SBRT followed by TACE and γ-SBRT alone , TACE followed by γ-SBRT may exert a negative effect on liver function . These results suggested that the combination of TACE and γ-SBRT may be considered a relatively effective , safe and feasible treatment method for primary HCC patients with PVTT , although TACE followed by γ-SBRT may negatively affect liver function Proton beam therapy ( PBT ) may provide useful local‐regional treatment for hepatocellular carcinoma ( HCC ) . The purpose of this study was to evaluate the safety and efficacy of PBT for HCC In the GRADE approach , r and omized trials
Output:
| For the comparison of radiotherapy plus chemoembolisation versus chemoembolisation alone , the risk ratio for one-year all-cause mortality was 0.51 ( 95 % confidence interval ( CI ) 0.41 to 0.62 ; P < 0.001 ; 9 trials ; low- quality evidence ) ; for complete response rate was 2.14 ( 95 % CI 1.47 to 3.13 ; P < 0.001 ; 7 trials ; low- quality evidence ) ; and for overall response rate defined as complete response plus partial response was 1.58 ( 95 % CI 1.40 to 1.78 ; P < 0.001 ; 7 trials ; low- quality evidence ) , all in favour of combined treatment with external beam radiotherapy plus transarterial chemoembolisation and seemingly supported by our Trial Sequential Analysis .
Additionally , the combined treatment was associated with a higher risk of elevated total bilirubin and elevated alanine aminotransferase .
AUTHORS ' CONCLUSIONS We found very low- and low- quality evidence suggesting that combined external beam radiotherapy and chemoembolisation may be associated with lower mortality and increased complete and overall response rates , despite an increased toxicity as expressed by a higher rise of bilirubin and alanine aminotransferase . |
MS213552 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background : Photodynamic therapy ( PDT ) is a method of microbial reduction which can benefit periodontal treatment in areas of difficult access , such as deep pockets and furcations . The aim of this r and omized controlled clinical trial was to evaluate the effects of PDT as an adjunct to full-mouth ultrasonic debridement in the treatment of severe chronic periodontitis . Material and Methods : Twenty-two patients with at least one pocket with a probing depth ( PD ) of ≥7 mm and one pocket with a PD of ≥5 mm and bleeding on probing ( BOP ) on each side of the mouth were included , characterizing a split mouth design . The control group underwent full-mouth ultrasonic debridement and the test group received the same treatment associated with PDT . The PDT was performed on only one side of the mouth and the initial step consisted of subgingival irrigation with 0.005 % methylene blue dye . Two minutes after applying the photosensitizer , the low power laser - AsGaAl ( Photon Lase III - PL7336 , DMC , São Carlos -São Paulo , Brazil ) was applied ( 660 nm , 100 mW , 9 J , 90 seconds per site , 320 J/cm2 , diameter tip 600 µm).The following clinical parameters were evaluated : plaque index , gingival index , BOP , gingival recession ( GR ) , PD , and clinical attachment level ( CAL ) . All parameters were collected before , 1 , 3 and 6 months after treatment . Results : An improvement in BOP , PD and CAL was observed after treatment , in both groups , but without any difference between them . After 6 months , the PD decreased from 5.11±0.56 mm to 2.83±0.47 mm in the test group ( p<0.05 ) and from 5.15±0.46 mm to 2.83±0.40 mm in the control group ( p<0.05 ) . The CAL changed , after 6 months , from 5.49±0.76 mm to 3.41±0.84 mm in the test group ( p<0.05 ) and from 5.53±0.54 to 3.39±0.51 mm in the control group ( p<0.05 ) . Conclusion : Both approaches result ed in significant clinical improvements in the treatment of severe chronic periodontits , however , the PDT did not provide any additional benefit to those obtained with full-mouth ultrasonic debridement used alone AIM To evaluate the potential of antimicrobial photodynamic therapy ( aPDT ) as an adjunct to scaling and root planing ( SRP ) in the treatment of chronic periodontitis . MATERIAL AND METHODS In a single-centred r and omized and controlled clinical trial , 90 patients ( 51 females and 39 males ) with untreated chronic periodontitis were r and omly assigned to receive SRP with aPDT ( test group ) or SRP alone ( control group ) . Clinical parameters and halitosis were recorded for 6 months after treatment by a periodontist who was blinded to the procedure . RESULTS Inter-group and intra-group statistical analyses were performed . Significant difference between the two groups with respect to each variable was assessed using non-parametric Rank Order ancova . Probing pocket depth and clinical attachment levels showed statistically significant reduction in the test group on evaluation at 3 months and 6 months as compared to the control group ( p < 0.05 ) . A statistically significant improvement in gingival index and gingival bleeding index was seen for the test group after 2 weeks and 1 month of aPDT ( p < 0.01 ) , whereas the improvement in gingival index and gingival bleeding index at 3 months and in plaque index at 2 weeks after aPDT was less ( p < 0.05 ) . Also , a significant difference was detected for the test group at 1 month in terms of halitosis ( p < 0.05 ) , which did not persist for long . CONCLUSIONS Antimicrobial photodynamic therapy acts as a beneficial adjunct to SRP in non-surgical treatment and management of chronic periodontitis in short-term . Further studies are required to assess the long-term effectiveness of aPDT This study aims to assess in residual periodontal pockets the clinical , microbiological , and local biological effects of antimicrobial photodynamic therapy ( PDT ) , delivered after ultrasonic instrumentation either once or twice in a 1-week interval . A single center , three-arm r and omized longitudinal study was carried out for 6 months . Twenty-eight systemically healthy patients on periodontal maintenance with residual pockets ( pocket depth ( PD ) ≥5 mm , clinical attachment loss ≥2 mm , and bleeding upon probing ( BOP+ ) ) were included . Residual pockets on three teeth , separated from each other by at least two other teeth , served as study sites . After ultrasonic debridement , they were r and omly assigned to either PDT delivered twice within 1 week ( group A ) , PDT delivered only once ( group B ) , or sham treatment without activating the laser ( group C ) . Methylene blue was applied with a blunt irrigator tip into the pockets . Sites were irradiated with laser light at a wavelength of 670 nm using a light-diffusing tip introduced into the pocket . Initial PD was 5.9 ± 0.9 , 6.3 ± 1.3 , and 6.3 ± 1.5 mm in groups A , B , and C , respectively , differences being nonsignificant . PD was significantly reduced in all groups . At month 3 , PD was significantly lower in groups A ( 2.9 ± 1.1 mm ; p = 0.04 ) and B ( 2.8 ± 1.1 mm ; p = 0.03 ) compared to group C ( 3.5 ± 1.2 mm ) . At month 6 , none of the sites in group A had persisting pockets PD > 4 mm and BOP+ , whereas two sites in group B and four sites in group C stayed in this category . Detection frequencies of the studied microorganisms at > 1,000 and > 100.000 cells/ml did not change significantly from baseline to months 3 or 6 in any group . A significant overall decrease was observed from baseline to month 6 for C-reactive protein , serum amyloid A , fibrinogen , procalcitonin , and α-2 macroglobulin . When looking at the groups separately , C-reactive protein was significantly lower only if the laser had been activated twice ( p < 0.05 ) . Other differences between groups were not significant . A single or double episodes of PDT had some additional benefit over ultrasonic instrumentation alone AIM A r and omized controlled clinical trial was design ed to evaluate the efficacy of the photodynamic therapy ( PDT ) in the treatment of residual pockets of chronic periodontitis patients . MATERIAL AND METHODS Thirty-four patients with at least four residual periodontal pockets undergoing maintenance care were included and r and omly assigned to test group ( PDT , n = 18 ) or control group ( sham procedure , n = 16 ) . The intervention was performed at baseline , 3 , 6 and 12 months . Clinical parameters such as pocket probing depth ( PPD ) , clinical attachment level ( CAL ) , bleeding on probing ( BoP ) and plaque index ( PI ) were measured before intervention and after 3 , 6 and 12 months . Subgingival sample s were obtained at baseline , and after 7 days , 3 , 6 and 12 months to quantify Aggregatibacter actinomycetemcomitans , Porphyromonas gingivalis , Treponema denticola and Tannerella forsythia by real-time polimerase chain reaction ( PCR ) . RESULTS All clinical variables showed significant improvement during the study , but there was no significant difference between test and control groups . The microbiological analyses showed no differences between groups at any time during the study . CONCLUSION Within the limits of this clinical trial and considering the laser and photosensitizer protocol used , PDT failed to demonstrate additional clinical and bacteriological benefits in residual pockets treatment Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results BACKGROUND Single photodynamic therapy ( PDT ) has been effective in initial periodontal therapy , but only improved bleeding on probing ( BoP ) in maintenance patients after a single use . Repeated PDT has not been addressed . OBJECTIVES To study the possible added benefits of repeated adjunctive PDT to conventional treatment of residual pockets in patients enrolled in periodontal maintenance . MATERIAL AND METHODS Ten maintenance patients with 70 residual pockets [ probing pocket depth (PPD)>or=5 mm ] were r and omly assigned for treatment five times in 2 weeks ( Days 0 , 1 , 2 , 7 , 14 ) with PDT ( test ) or non-activated laser ( control ) following debridement . The primary outcome variable was PPD , and the secondary variables were clinical attachment level ( CAL ) and BoP. These were assessed at 3 , 6 and 12 months following the interventions . RESULTS Greater PPD reductions were observed in the test ( -0.67 + /- 0.34 ; p=0.01 ) compared with the control patients ( -0.04 + /- 0.33 ; NS ) after 6 months . Significant CAL gain ( + 0.52 + /- 0.31 ; p=0.01 ) was noted for the test , but not in the control ( -0.27 + /- 0.52 ; NS ) patients after 6 months . BoP percentages decreased significantly in test ( 97 - 64 % , 67 % , 77 % ) , but not control patients after 3 , 6 and 12 months . CONCLUSIONS Repeated ( five times ) PDT adjunctive to debridement yielded improved clinical outcomes in residual pockets in maintenance patients . The effects were best documented after 6 months BACKGROUND The study aims to compare the effects of adjunctive photodynamic therapy ( PDT ) with scaling and root debridement alone on periodontal parameters and inflammatory cytokines in residual pockets of patients undergoing maintenance therapy . METHODS 27 subjects , each with at least 2 residual pockets ≥5 mm , were recruited for this r and omized , split-mouth controlled trial , providing total of 72 sites . Probing pocket depth ( PPD ) , recession , clinical attachment loss ( CAL ) , plaque and bleeding on probing of all sites were examined at baseline , 3 and 6 months . Gingival crevicular fluids ( GCFs ) were collected to determine levels of IL-1β , IL-6 , IL-8 , TNF-α and MMP-8 via enzyme-linked immunosorbent assay . At baseline , all sites received subgingival instrumentation and polishing . In addition , test sites received a single application of PDT using Fotosan ® with toluidine blue O solution photosensitizer . At 3 and 6 months , site level analysis was performed for changes in clinical parameters and cytokine level . RESULTS Based on mixed model analysis , at 3 months , test sites showed significant reduction in CAL ( p=0.016 ) and PPD ( p=0.027 ) ( from 6.14±0.28 mm to 5.49±0.20 mm and 5.42±0.16 mm to 4.65±0.18 mm respectively ) compared to control sites ( from 6.32±0.24 mm to 6.08±0.17 mm and 5.32±0.13 mm to 5.15±0.15 mm respectively ) . At 6 months , these differences were no longer significant ( p=0.510 ) . Adjunctive PDT did not offer additional reduction in levels of GCF cytokines . CONCLUSIONS A single application of PDT to residual pockets provided a modest improvement of CAL and PPD over 3 months . Application of adjunctive PDT may lead to
Output:
| Concluding , it was not possible to state that repeated applications of aPDT , in association with non-surgical treatment of residual pockets , have effective clinical effects in the periodontal maintenance therapy . |
MS213553 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Two hundred and forty neurotic out- patients were allocated to no diagnostic category but were rated in terms of observer and self ratings of both depression and anxiety at weekly intervals during a 4-week trial of amitriptyline , diazepam , amitriptyline and diazepam , and placebo . The sample could not be divided into anxious and depressed groups on the basis of the clinical picture . The outcome tended to be good irrespective of medication but the significant drug effects found were due to amitriptyline and concerned measures of anxiety as well as depression . It is concluded that a distinction between anxiety and depression in neurotic out- patients is of no practical value with regard to drug treatment Abstract . Rationale : A large proportion of patients with major depression do not respond sufficiently to any first-line treatment . Objectives : The aim of this study was to compare a strategy of sertraline dose increase with a strategy of adding mianserin in patients with major depression insufficiently responding to 6 weeks of open treatment with sertraline , controlling for the effect of an extended duration of treatment . Methods : One thous and six hundred and twenty-nine patients , 18–65 years of age , with major depression scoring at least 18 on the 17-item Hamilton depression scale ( HDS ) were treated openly with 50 mg/day sertraline , and patients who after 4 weeks had not responded ( achieving at least a 50 % reduction in score on the HDS ) were treated with 100 mg/day sertraline for an additional 2-week period . The patients who had still not responded were then r and omised to double-blind treatment for an additional 5 weeks with either 100 mg/day sertraline plus placebo , 200 mg/day sertraline plus placebo or 100 mg/day sertraline plus 30 mg/day mianserin . Results : After 6 weeks of open treatment , 60 % had responded and 22 % had dropped out , leaving 295 non-responding patients ( 18 % ) for r and omisation . In the intention-to-treat- analysis , continuing the treatment with 100 mg/day sertraline result ed in response in 70 % of the non-responders , similar to the response rate ( 67 % ) obtained in the patients who had mianserin added . However , increasing the sertraline dose to 200 mg/day result ed in a lower response rate at 56 % ( P<0.05 ) . Similar results were seen in the completers . A substantial increase in the accumulated response rate from week 6 to week 8 was seen . There was no influence of baseline variables , including the presence of melancholic features on the overall post-r and omisation response rate . Conclusion : After 6 weeks of insufficient antidepressant treatment with 50–100 mg/day sertraline , a continued treatment with 100 mg/day sertraline can be considered until at least week 8 before considering changing strategy , unless the condition deteriorates CONTEXT Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions . OBJECTIVE To explore whether the association between funding and conclusions in r and omized drug trials reflects treatment effects or adverse events . DESIGN Observational study of 370 r and omized drug trials included in meta-analyses from Cochrane review s selected from the Cochrane Library , May 2001 . From a r and om sample of 167 Cochrane review s , 25 contained eligible meta-analyses ( assessed a binary outcome ; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment ) . The primary binary outcome from each meta- analysis was considered the primary outcome for all trials included in each meta- analysis . The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect , adverse events , and additional confounding factors ( method ological quality , control intervention , sample size , publication year , and place of publication ) . MAIN OUTCOME MEASURE Conclusions in trials , classified into whether the experimental drug was recommended as the treatment of choice or not . RESULTS The experimental drug was recommended as treatment of choice in 16 % of trials funded by nonprofit organizations , 30 % of trials not reporting funding , 35 % of trials funded by both nonprofit and for-profit organizations , and 51 % of trials funded by for-profit organizations ( P<.001 ; chi2 test ) . Logistic regression analyses indicated that funding , treatment effect , and double blinding were the only significant predictors of conclusions . Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice ( odds ratio , 5.3 ; 95 % confidence interval , 2.0 - 14.4 ) compared with trials funded by nonprofit organizations . This association did not appear to reflect treatment effect or adverse events . CONCLUSIONS Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results . Readers should carefully evaluate whether conclusions in r and omized trials are supported by data This study examines the scientific basis for mental health intervention programs in primary care . The validity of five underlying assumptions is evaluated , using the results of a naturalistic study covering a representative sample of 25 Dutch family practice s and data from the literature . Our findings corroborate the validity of the assumptions . Firstly , our study indicates that mental disorders are indeed very prevalent in primary care setting s. Secondly , we find that a substantial proportion of mental disorders is not recognized by the general practitioner ( GP ) . Thirdly , our data show that mental disorders in primary care are not transient or self-limiting . Fourthly , it is shown that only half of the GP attenders with a mental disorder receive some form of mental health treatment in the 14 months after their index consultation . Finally , our data suggest that mental disorders , when identified , can be treated effectively in primary care . These findings are in general agreement with the literature . In the discussion we underscore the need for public health intervention programs targeted at primary care providers . Training programs for general physicians must be directed at improving recognition and diagnosis and at enhancing the availability and quality of mental health interventions . The effectiveness of these programs has to be tested in r and omized trials Four hundred and thirty-four patients suffering from mild to moderate depression were recruited into a double-blind multicentre general practice study and r and omly received either Limbitrol ( 25 mg amitriptyline and 10 mg chlordiazepoxide ) or amitriptyline 25 mg in matching white capsules given as a single night-time dose . The dose was titrated to a maximum of four capsules per night . Patients were assessed on entry and at 7-day intervals for depressive state ( Hamilton Rating Scale for Depression ) , cardiovascular effect and side-effects for 28 days . Self- assessment s of depression and anxiety using the Leeds Scale were made in the form of a patient question naire . Both groups showed significant improvement at each visit and significantly more patients improved after 7 days in the Limbitrol group . There was no significant difference in treatment over all between groups , in the incidence of side-effects , or in the effects on the heart Objective : To assess , in depressed patients , the clinical benefit of mianserin augmentation of fluoxetine or the the benefit of switching treatment from fluoxetine to mianserin The primary goal of this study was to determine whether the amphetamine challenge test ( ACT ) response , as measured by a subjective rating scale , the How I Feel Scale ( HIF ) , could predict antidepressant treatment outcome . Following a 1-day non-blind ACT with dextroamphetamine ( d-AMPH ) , patients were treated double-blind for 6 weeks with either desipramine , alprazolam , or a desipramine-alprazolam combination . Regression ( true score ) analyses were carried out on pre- and post-ACT HIF scores and on baseline and end of study Hamilton Depression Rating Scale ( HDRS ) scores to determine the magnitudes of improvement measured in response to the ACT and antidepressant treatment , respectively . Regression analyses were performed on the residuals ( true scores of improvement ) to determine the best fitting ( linear ) prediction equation . Improvement in the HIF total score predicted HDRS improvement for the whole sample . Possible sources of error contributing to the outcome are identified and the results are discussed in relation to previous clinical investigations of the potential usefulness of the ACT as a predictor of antidepressant response BACKGROUND Clonazepam cotherapy of fluoxetine was previously demonstrated to accelerate efficacy over the first 3 weeks of treatment . A new 18-week double-blind study attempted to replicate these findings to determine whether superiority would extend to 3 months and assess risks of extension . METHOD Fifty outpatient volunteers aged 18 - 65 from Seattle and Portl and with moderate-marked depression received fluoxetine ( 20 mg ) doubled at 6 weeks if needed ; half took clonazepam ( 0.5 mg ) and half took an identical placebo , 1 or 2 tablets adjusted during the first 2 weeks , until a 3-week taper at 3 months . RESULTS No serious adverse events and no special problems with sedation or discontinuation were noted . Cotherapy was superior to fluoxetine monotherapy at Day 7 for HAM-D ( t=2.03 , df=48 , P<0.05 ) and CGI-I ( 32 vs. 4 % responders , P<0.03 , Fisher Exact Test ) but not otherwise . Cotherapy was effective in reducing insomnia but not anxiety or core symptoms ( low mood , suicidality , reduced interest ) . The only significant benefit of extending treatment was a more rapid response to increased fluoxetine at 6 weeks manifested in a mean HAM-D of 9.0 and CGI-I responder rate of 76 % after 8 weeks compared to 16 weeks for monotherapy . LIMITATIONS Small sample size ( N=50 ) limited power and rendered conclusions tentative . CONCLUSIONS Extended clonazepam cotherapy of fluoxetine appeared safe and effective for depressed out patients : it was superior to fluoxetine alone early in treatment and again following fluoxetine dose increase . Cotherapy might be considered at the start of fluoxetine treatment , especially for those with insomnia , and when a dose increase of fluoxetine is anticipated In a multicenter , placebo-controlled , clinical trial , the efficacy of Limbitrol was compared with that of its components , amitriptyline and chlordiazepoxide . All patients had a diagnosis of primary depression . Data from 279 patients were evaluated using the Hamilton depression scale , the Beck depression inventory , and physician and patient global change measures .Statistically significant differences favoring Limbitrol occurred after 1 week of treatment , and a trend in favor of Limbitrol continued throughout the remaining 3 weeks . In most efficacy comparisons , the combination was as good as , or better than , amitriptyline alone . It was superior to chlordiazepoxide alone after 2 and 4 weeks of treatment . Each component produced an independent contribution to the total therapeutic effect : the chlordiazepoxide effect was more prominent in the first 2 weeks and the amitriptyline effect in the latter 2 weeks . A trend favoring amitriptyline over chlordiazepoxide was evident by week 4.The overall incidence of side effects was comparable in both Limbitrol- and amitriptyline-treated groups . Limbitrol-treated patients exhibited more sedation , but significantly fewer Limbitrol patients discontinued treatment prematurely because of side effects 1 . Ninety healthy adult men participated in a study of the effects on performance of 60 mg fluoxetine , 50 mg amitriptyline or placebo , alone and in combination with 5 mg diazepam or placebo . 2 . In a 2X3 factorial design study , groups of 15 Ss received one of six possible treatment combinations . 3 . Ss were tested with a battery of laboratory tests at two post-dosing times . 4 . Amitriptyline impaired the performance of all tasks . When diazepam was added to the amitriptyline treatment , the impairment of three tasks increased . Diazepam alone produced impairment on two measures . 5 . Fluoxetine alone impaired no task ; some impairment occurred with the fluoxetine-diazepam combination Chlordiazepoxide-amitriptyline ( Limbitrol ) has been shown to be more rapidly effective than amitriptyline alone for treating depression . A double-blind , r and omized study was design ed to compare the effects of Limbitrol and amitriptyline on insomnia , anxiety , and depression . The rate of improvement of symptoms was faster with Limbitrol . No differences were noted between groups in the degree or rate of improvement of the sleep laboratory parameters nor in sleep Stages 1 to 4 . Percentages of rapid eye movement ( REM ) sleep and REM latency were similarly affected by the drugs , but REM density showed a significantly greater decrease with Limbitrol . Phasic REM factors may be crucial in the role of REM sleep and depression BACKGROUND Undertreatment of depression appears widespread but the available literature is limited to North American and European countries . We aim ed to examine the treatment received by patients with major depression in Japan and to eluci date any predictor of their treatment level . METHODS A naturalistic , prospect i ve follow-up study of an inception cohort of subjects with mood disorders was undertaken in psychiatric departments of 13 university hospitals , those of six general hospitals , three mental hospitals and one community mental health center from all over Japan . A total of 95 patients without any prior antidepressant treatment were diagnosed with major depression according to DSM-IV and were followed up every month until treatment termination and every 6 months thereafter . RESULTS The follow-up information was available in 98 to
Output:
| Combined antidepressant plus benzodiazepine therapy was more effective than antidepressants alone in improving depression severity , response in depression and remission in depression in the early phase .
However , these effects were not maintained in the acute or the continuous phase .
Combined therapy result ed in fewer dropouts due to adverse events than antidepressants alone , but combined therapy was associated with a greater proportion of participants reporting at least one adverse effect . |
MS213554 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The potential for traditional birth attendants ( TBAs ) to improve neonatal health outcomes has largely been overlooked during the current debate regarding the role of TBAs in improving maternal health . R and omly-selected TBAs ( n=93 ) were interviewed to gain a more thorough underst and ing of their knowledge , attitudes , and practice s regarding maternal and newborn care . Practice s , such as using a clean cord-cutting instrument ( 89 % ) and h and -washing before delivery ( 74 % ) , were common . Other beneficial practice s , such as thermal care , were low . Trained TBAs were more likely to wash h and s with soap before delivery , use a clean delivery-kit , and advise feeding colostrum . Although mustard oil massage was a universal practice , 52 % of the TBAs indicated their willingness to consider alternative oils . Low-cost , evidence -based interventions for improving neonatal outcomes might be implemented by TBAs in this setting where most births take place in the home and neonatal mortality risk is high . Continuing efforts to define the role of TBAs may benefit from an emphasis on their potential as active promoters of essential newborn care A study was carried out in Misungwi and Kwimba Districts , Tanzania to determine the effectiveness of clean delivery kits in preventing cord infection and puerperal sepsis and to provide qualitative information on community acceptability , correct use , and appropriateness of the kits . This study involved pregnant women aged 18 - 45 years old . In the delivery kit intervention population , the Maternal and Child Health Aide ( MCHA ) assigned to the health facility provided pregnant mothers with a clean delivery kit on their first antenatal visit . She explained how to use each of the kit components , with the aid of pictorial instructions included in the kit . The pregnant mothers were asked to convey the information to whoever assisted them during delivery . The MCHA also gave them health education based on the principles of the " six cleans " recognized by WHO ( i.e. , clean h and s , clean perineum , clean delivery surface , clean cord cutting and tying instruments , clean cutting surface ) . Women received the clean delivery kit free of charge in accordance with the r and omised stepped-wedge design schedule . During the first week following delivery , the Village Health Workers ( VHWs ) from both the intervention and control groups made two visits to the households of mothers who had delivered . They administered question naire about delivery to mother and birth attendant . During the two scheduled postpartum visits , those who were suspected to have puerperal sepsis or cord infection of the baby were referred to the health facility clinician for confirmation . Results indicated that use of clean delivery kit had a positive effect on reducing both cord infection and puerperal sepsis . The use of a clean home delivery kit coupled with an educational intervention about the " six cleans " had a significant effect on reducing the incidence of cord infection and puerperal sepsis among women enrolled in the study . In low re source setting s where home birth is common and clean delivery supplies are scarce , disposable kits can be made available through health clinics , markets , pharmacies or other channels to help reduce rates of infection BACKGROUND There are approximately 4 million neonatal deaths and half a million maternal deaths worldwide each year . There is limited evidence from clinical trials to guide the development of effective maternity services in developing countries . METHODS We performed a cluster-r and omized , controlled trial involving seven subdistricts ( talukas ) of a rural district in Pakistan . In three talukas r and omly assigned to the intervention group , traditional birth attendants were trained and issued disposable delivery kits ; Lady Health Workers linked traditional birth attendants with established services and documented processes and outcomes ; and obstetrical teams provided outreach clinics for antenatal care . Women in the four control talukas received usual care . The primary outcome measures were perinatal and maternal mortality . RESULTS Of the estimated number of eligible women in the seven talukas , 10,114 ( 84.3 percent ) were recruited in the three intervention talukas , and 9443 ( 78.7 percent ) in the four control talukas . In the intervention group , 9184 women ( 90.8 percent ) received antenatal care by trained traditional birth attendants , 1634 women ( 16.2 percent ) were seen antenatally at least once by the obstetrical teams , and 8172 safe-delivery kits were used . As compared with the control talukas , the intervention talukas had a cluster-adjusted odds ratio for perinatal death of 0.70 ( 95 percent confidence interval , 0.59 to 0.82 ) and for maternal mortality of 0.74 ( 95 percent confidence interval , 0.45 to 1.23 ) . CONCLUSIONS Training traditional birth attendants and integrating them into an improved health care system were achievable and effective in reducing perinatal mortality . This model could result in large improvements in perinatal and maternal health in developing countries OBJECTIVE To determine the feasibility and acceptability of providing clean birth kits ( CBKs ) containing misoprostol for self-administration in a rural setting in Papua New Guinea . METHODS A prospect i ve intervention study was conducted between April 8 , 2013 , and October 24 , 2014 . Eligible participants were women in the third trimester of pregnancy who attended a prenatal clinic in Unggai Bena . Participants received individual instruction and were then given a CBK containing 600μg misoprostol tablets for self-administration following an unsupervised birth if they could demonstrate their underst and ing of correct use of items in the CBK . Data regarding the use and acceptability of the CBK and misoprostol were collected during postpartum follow-up . RESULTS Among 200 participants , 106 ( 53.0 % ) had an unsupervised birth , and 99 ( 93.4 % ) of these women used the CBK . All would use the CBK again and would recommend it to others . Among these 99 women , misoprostol was self-administered by 98 ( 99.0 % ) , all of whom would take the drug again and would recommend it to others . CONCLUSION The findings strengthen the case for community-based use of misoprostol to prevent postpartum hemorrhage in remote communities . Large-scale interventions should be planned to further evaluate impact and acceptability
Output:
| Quantitative studies showed a positive impact of CBKs on reducing the incidence of puerperal sepsis and neonatal tetanus .
The review also identified CBK use to be associated with a reduction in perinatal , neonatal and young infant mortality .
Qualitative studies suggested that a lack of awareness of the importance of CBKs and clean delivery practice s , unavailability of CBKs and financial constraints to purchase CBKs were the potential barriers .
CBKs appear to be a promising strategy to reduce maternal and neonatal morbidity and mortality . |
MS213555 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: CONTEXT Data are sparse on the effect of varying the duration s of internal medicine attending physician ward rotations . OBJECTIVE To compare the effects of 2- vs 4-week inpatient attending physician rotations on unplanned patient revisits , attending evaluations by trainees , and attending propensity for burnout . DESIGN , SETTING , AND PARTICIPANTS Cluster r and omized crossover noninferiority trial , with attending physicians as the unit of crossover r and omization and 4-week rotations as the active control , conducted in a US university-affiliated teaching hospital in academic year 2009 . Participants were 62 attending physicians who staffed at least 6 weeks of inpatient service , the 8892 unique patients whom they discharged , and the 147 house staff and 229 medical students who evaluated their performance . INTERVENTION Assignment to r and om sequences of 2- and 4-week rotations . MAIN OUTCOME MEASURES Primary outcome was 30-day unplanned revisits ( visits to the hospital 's emergency department or urgent ambulatory clinic , unplanned readmissions , and direct transfers from neighboring hospitals ) for patients discharged from 2- vs 4-week within-attending-physician rotations . Noninferiority margin was a 2 % increase ( odds ratio [ OR ] of 1.13 ) in 30-day unplanned patient revisits . Secondary outcomes were length of stay ; trainee evaluations of attending physicians ; and attending physician reports of burnout , stress , and workplace control . RESULTS Among the 8892 patients , there were 2437 unplanned revisits . The percentage of 30-day unplanned revisits for patients of attending physicians on 2-week rotations was 21.2 % compared with 21.5 % for 4-week rotations ( mean difference , -0.3 % ; 95 % CI , -1.8 % to + 1.2 % ) . The adjusted OR of a patient having a 30-day unplanned revisit after 2- vs 4-week rotations was 0.97 ( 1-sided 97.5 % upper confidence limit , 1.07 ; noninferiority P = .007 ) . Average length of stay was not significantly different ( geometric means for 2- vs 4-week rotations were 67.2 vs 67.5 hours ; difference , -0.9 % ; 95 % CI , -4.7 % to + 2.9 % ) . Attending physicians were more likely to score lower in their ability to evaluate trainees after 2- vs 4-week rotations by both house staff ( 41 % vs 28 % rated less than perfect ; adjusted OR , 2.10 ; 95 % CI , 1.50 - 3.02 ) and medical students ( 82 % vs 69 % rated less than perfect ; adjusted OR , 1.41 ; 95 % CI , 1.06 - 2.10 ) . They were less likely to report higher scores of both burnout severity ( 16 % vs 35 % ; adjusted OR , 0.39 ; 95 % CI , 0.26 - 0.58 ) and emotional exhaustion ( 19 % vs 37 % ; adjusted OR , 0.45 ; 95 % CI , 0.31 to 0.64 ) after 2- vs 4-week rotations . CONCLUSIONS The use of 2-week inpatient attending physician rotations compared with 4-week rotations did not result in an increase in unplanned patient revisits . It was associated with better self-rated measures of attending physician burnout and emotional exhaustion but worse evaluations by trainees . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00930111 Background : Shorter resident duty periods are increasingly m and ated to improve patient safety and physician well-being . However , increases in continuity-related errors may counteract the purported benefits of reducing fatigue . We evaluated the effects of 3 resident schedules in the intensive care unit ( ICU ) on patient safety , resident well-being and continuity of care . Methods : Residents in 2 university-affiliated ICUs were r and omly assigned ( in 2-month rotation-blocks from January to June 2009 ) to in-house overnight schedules of 24 , 16 or 12 hours . The primary patient outcome was adverse events . The primary resident outcome was sleepiness , measured by the 7-point Stanford Sleepiness Scale . Secondary outcomes were patient deaths , preventable adverse events , and residents ’ physical symptoms and burnout . Continuity of care and perceptions of ICU staff were also assessed . Results : We evaluated 47 ( 96 % ) of 49 residents , all 971 admissions , 5894 patient-days and 452 staff surveys . We found no effect of schedule ( 24- , 16- or 12-h shifts ) on adverse events ( 81.3 , 76.3 and 78.2 events per 1000 patient-days , respectively ; p = 0.7 ) or on residents ’ sleepiness in the daytime ( mean rating 2.33 , 2.61 and 2.30 , respectively ; p = 0.3 ) or at night ( mean rating 3.06 , 2.73 and 2.42 , respectively ; p = 0.2 ) . Seven of 8 preventable adverse events occurred with the 12-hour schedule ( p = 0.1 ) . Mortality rates were similar for the 3 schedules . Residents ’ somatic symptoms were more severe and more frequent with the 24-hour schedule ( p = 0.04 ) ; however , burnout was similar across the groups . ICU staff rated residents ’ knowledge and decision-making worst with the 16-hour schedule . Interpretation : Our findings do not support the purported advantages of shorter duty schedules . They also highlight the trade-offs between residents ’ symptoms and multiple secondary measures of patient safety . Further delineation of this emerging signal is required before widespread system change . Trial registration : Clinical Trials.gov , no. NCT00679809 PURPOSE The increasing use of electronic medical records during the clinical encounter brings not only benefits but also barriers that may affect the doctor-patient relationship and increase the work burden of the physician . We evaluated whether the use of an electronic medical record scribe in an academic urology program would ameliorate these problems . MATERIAL S AND METHODS We r and omly assigned electronic medical record scribes to the office hours of 5 academic urologists , and using surveys we evaluated patient and physician acceptance and satisfaction . RESULTS Patients were accepting of an electronic medical record scribe and satisfaction rates were high ( 93 % vs 87 % in the absence of a scribe , p = 0.36 ) . Patients were comfortable disclosing urological information in the presence of the scribe . Physicians were dramatically more satisfied with office hours when a scribe was present ( 69 % vs 19 % , p < 0.001 ) . We were unable to determine whether the presence of a scribe improves productivity . CONCLUSIONS Electronic medical record scribes in a urology practice may be a practical solution to provide documentation while maintaining or improving the doctor-patient relationship because they increase physician satisfaction and do not detract from patient satisfaction OBJECTIVE . To mitigate the risks of fatigue-related medical errors , the Accreditation Council for Graduate Medical Education introduced work hour limits for resident physicians in 2003 . Our goal was to determine whether work hours , sleep , and safety changed after implementation of the Accreditation Council for Graduate Medical Education st and ards . METHODS . We conducted a prospect i ve cohort study in which residents from 3 large pediatric training programs provided daily reports of work hours and sleep . In addition , they completed reports of near-miss and actual motor vehicle crashes , occupational exposures , self-reported medical errors , and ratings of educational experience . They were screened for depression and burnout . Concurrently , at 2 of the centers , data on medication errors were collected prospect ively by using an established active surveillance method . RESULTS . A total of 220 residents provided 6007 daily reports of their work hours and sleep , and 16 158 medication orders were review ed . Although scheduling changes were made in each program to accommo date the st and ards , 24- to 30-hour shifts remained common , and the frequency of residents ’ call remained largely unchanged . There was no change in residents ’ measured total work hours or sleep hours . There was no change in the overall rate of medication errors , and there was a borderline increase in the rate of resident physician ordering errors , from 1.06 to 1.38 errors per 100 patient-days . Rates of motor vehicle crashes , occupational exposures , depression , and self-reported medical errors and overall ratings of work and educational experiences did not change . The mean length of extended- duration ( on-call ) shifts decreased 2.7 % to 28.5 hours , and rates of resident burnout decreased significantly ( from 75.4 % to 57.0 % ) . CONCLUSIONS . Total hours of work and sleep did not change after implementation of the duty hour st and ards . Although fewer residents were burned out , rates of medication errors , resident depression , and resident injuries and educational ratings did not improve RATIONALE Around-the-clock intensivist presence in intensive care units ( ICUs ) has been promoted as necessary to optimize outcomes . Little data have addressed how it affects the multiple stakeholders in such care . OBJECTIVES To assess effects of around-the-clock intensivist presence on intensivists , patients , families , housestaff , and nurses . METHODS This 32-week , crossover pilot trial of two intensivist staffing models , performed in two Canadian ICUs , alternated 8-week blocks of two staffing models : the st and ard model , where one intensivist worked for 7 days , taking night call from home ; and the shift work model , where one intensivist worked 7 day shifts , while other intensivists remained in the ICU at night . MEASUREMENTS AND MAIN RESULTS Surveys scaled from 0 - 100 points assessed outcomes for 24 intensivists ( primary outcome : burnout ) ; 119 families ( satisfaction ) ; 74 nurses ( satisfaction with collaboration and communications , role conflict ) ; and 34 housestaff ( autonomy , supervision , and learning opportunities ) . Outcomes for 501 patients included mortality , length of stay , and re source use . Intensivists doing shift work experienced less burnout ( -6.9 points ; P = 0.04 ) . Adjusted hospital mortality ( odds ratio , 1.22 ; P = 0.44 ) , ICU length of stay ( -6 h ; P = 0.46 ) , and family satisfaction ( 0.9 points ; P = 0.79 ) did not differ between staffing models . Under shift work staffing , nurses reported more role conflict ( 9 points ; P < 0.001 ) , whereas nighttime housestaff reported less autonomy , more supervision , but no difference in learning opportunities . CONCLUSIONS Shiftwork staffing was better for intensivists and most were receptive once they had experienced it . Although there were no evident negative outcomes for patients or families , further evaluation is needed to clarify how around-the-clock intensivist staffing influences the various stakeholders in ICU care , given power considerations in this study . Clinical trial registered with www . clinical trials.gov ( NCT 01146691 ) Background Use of electronic health records ( EHRs ) is associated with physician stress and burnout . While emergency departments and subspecialists have used scribes to address this issue , little is known about the impact of scribes in academic primary care . Objective Assess the impact of a scribe on physician and patient satisfaction at an academic general internal medicine ( GIM ) clinic . Design Prospect i ve , pre-post-pilot study . During the 3-month pilot , physicians had clinic sessions with and without a scribe . We assessed changes in ( 1 ) physician workplace satisfaction and burnout , ( 2 ) time spent on EHR documentation , and ( 3 ) patient satisfaction . Participants Six GIM faculty and a convenience sample of their patients ( N = 325 ) at an academic GIM clinic . Main Measures A 21-item pre- and 44-item post-pilot survey assessed physician workplace satisfaction and burnout . Physicians used logs to record time spent on EHR documentation outside of clinic hours . A 27-item post-visit survey assessed patient satisfaction during visits with and without the scribe . Key Results Of six physicians , 100 % were satisfied with clinic workflow post-pilot ( vs. 33 % pre-pilot ) , and 83 % were satisfied with EHR use post-pilot ( vs. 17 % pre-pilot ) . Physician burnout was low at baseline and did not change post-pilot . Mean time spent on post-clinic EHR documentation decreased from 1.65 to 0.76 h per clinic session ( p = 0.02 ) . Patient satisfaction was not different between patients who had clinic visits with vs. without scribe overall or by age , gender , and race . Compared to patients 65 years or older , younger patients were more likely to report that the physician was more attentive and provided more education during visits with the scribe present ( p = 0.03 and 0.02 , respectively ) . Male patients were more likely to report that they disliked having a scribe ( p = 0.03 ) . Conclusion In an academic GIM setting , employment of a scribe was associated with improved physician satisfaction without compromising patient satisfaction PURPOSE Comprehensiveness is lauded as 1 of the 5 core virtues of primary care , but its relationship with outcomes is unclear . We measured associations between variations in comprehensiveness of practice among family physicians and healthcare utilization and costs
Output:
| The largest benefits result ed from interventions that improved processes , promoted team-based care , and incorporated the use of scribes/medical assistants to complete EHR documentation and tasks .
Implementation of EHR interventions to improve clinical workflows worsened burnout , but EHR improvements had positive effects .
Time interventions had mixed effects on burnout .
The results of our study suggest that organization-directed workplace interventions that improve processes , optimize EHRs , reduce clerical burden by the use of scribes , and implement team-based care can lessen physician burnout .
Benefits of process changes can enhance physician resiliency , augment care provided by the team , and optimize the coordination and communication of patient care and health information |
MS213556 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Objective High NH3 emissions from poultry houses are reported to have negative impacts on health , welfare and safety of birds and humans , and on the environment . Objective of the present study was to determine the effects of two litter amendments on the NH3 levels in broiler closed houses under hot-humid conditions . Methods Giving a completely r and omize design , nine closed houses , each housed 32,500 birds on paddy husk litter , were r and omly allocated into two treatment ( Mizuho ; a bacterial culture mix and Rydall OE ; an enzymatic biocatalyst ) and control groups . NH3 levels were determined thrice a day ( 0600 , 1200 , and 1800 h ) , at three heights from the litter surface ( 30 , 90 , and 150 cm ) , at 20 predetermined locations of a house , from day 1 to 41 . Results Rydall significantly reduced the NH3 level compared to control and Mizuho . NH3 levels at 30 cm were significantly higher than that of 90 and 150 cm . The NH3 levels at 30 cm height were higher than 25 ppm level from day 9 , 11 , and 13 in Mizuho , control , and Rydall groups , respectively to day 41 . NH3 levels at 150 cm height were higher than maximum threshold limit of 50 ppm for human exposure from day 12 , 14 , and 15 in Mizuho , control , and Rydall groups , respectively to day 33 . Being significantly different among each other , the NH3 level was highest and lowest at 0600 and 1800 h. Litter amendments had no significant effects on growth performance . Rydall significantly increased the litter N content on day 24 . Conclusion It was concluded that the NH3 levels of closed house broiler production facilities under tropical condition are so high that both birds and workers are exposed to above recommended levels during many days of the growing period . Compared to microbial culture , the enzymatic biocatalyst was found to be more effective in reducing NH3 level Two commercially available litter treatments , aluminum sulfate and sodium bisulfate , were tested to determine their effect on Campylobacter and Salmonella levels associated with commercial broilers during a 6-wk grow-out period . A total of 20 broiler houses at 10 different locations were studied ; 5 aluminum sulfate-treated houses , 5 sodium bisulfate-treated houses , and 10 paired , untreated control houses . A single application rate was investigated for each treatment . Fecal sample s ( n=20 per house ) were analyzed at wk 2 , 4 , and 5 and 6 for Campylobacter and Salmonella . The results indicated that , at the application rates investigated , both acidifying litter treatments caused a slight delay in the onset of Campylobacter colonization in broiler chicks . Salmonella levels remained unaffected , with no significant effect seen with either treatment ( P > 0.05 ) . Campylobacter population s and Salmonella incidence associated with unprocessed , whole-carcass rinse sample s ( n=10 per house ) analyzed at the end of production ( wk 5 and 6 ) were unaffected by treatment The survival of Salmonella Typhimurium LT2 in r and omly packed beds of glass beads , microporous silica particles and Sephadex microspheres is examined . It is shown that the decrease in the percentage cell recovery in these porous material s at reduced water content is not correlated with the global water activity as determined by conventional vapour pressure measurements but rather with the osmotic shock induced by the sudden redistribution of water and air among the microscopic pores in the matrix surrounding the cells . For this reason the bacterial survival and growth data correlates best with physical measurements , such as NMR and electrical conductivity , which are sensitive to the microscopic air-water distribution . The implication s of this observation in food safety and preservation are discussed ABSTRACT The litter quality is an important factor affecting the performance , welfare and carcass quality of the broilers . Depending on the progress of the fattening duration , some material s may be added to the litter in order to keep the pH , moisture and ammonia levels in the litter under control . Sepiolite is a natural material and it has strong absorbing ability to the water . Therefore , the aim of this study was to determine the effects of sepiolite additions to different litter material s on performance and some welfare parameters of broilers and litter characteristics . A total of 288 1‐d‐old male broiler chicks ( ROSS‐308 ) were used . Birds were r and omly allocated to 2 litters ( wood shavings and rice hull ) and 3 sepiolite groups ( 0 , 25 , 50 % ) with 6 replication , and each pen contains 8 chicks . Fattening performance , IgG , tonic immobility period , feather score , skin injures , breast burns , and footpad burns of broilers were not affected significantly by sepiolite additions to the litter . However , sepiolite addition to the litter can improve litter quality . There was no significant difference between 2 litter material s because both have same color . There were no significant interactions in examined parameters . In conclusion , addition of sepiolite at 25 and 50 % levels to litter material s may be used as a litter material in the broiler production without adverse welfare and performance problem
Output:
| Conclusion None of the litter treatments influenced the feed intake of broilers .
Meta-analyses of the selected studies showed positive and significant effects of the litter treatments on broiler performance and litter quality when compared with controls .
Alkalizing was associated with worse feed conversion and high mortality of broilers |
MS213557 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Pathologists are under increasing pressure to su bmi t fresh tissue for ancillary studies and research protocol s. In several tumor types ( breast , lung , melanoma , colorectal , prostate ) , increased interest in detecting su bmi croscopic nodal metastases through reverse transcriptase polymerase chain reaction analysis of mRNA from portions of lymph nodes has precluded histologic analysis of the entire node for metastases . A retrospective review was undertaken of 227 breast cancer patients prospect ively entered on a research protocol examining the usefulness of sentinel lymph node surgery . All of the patients ultimately underwent complete lymph node dissection . The research protocol required that all nodes greater than 8 mm in size be bisected and su bmi tted separately . Positive lymph nodes were evaluated for unilateral or bilateral involvement in the node sections . Sixty node-positive patients were identified , yielding 230 positive nodes . One hundred seven of these nodes were confirmed to have been bisected . Carcinoma was identified in both lymph node sections in 64 ( 59.8 % ) nodes and in only one-half of the bisected lymph node in 43 ( 40.2 % ) nodes . Involvement of both sections was more likely when patients had multiple nodes positive . In 12 patients , involvement of one-half of the bisected nodes was the only evidence of metastatic disease ( 20.0 % of node-positive patients ) . This evidence suggests that su bmi ssion of less than the complete lymph node for histologic evaluation of metastatic disease decreases the accuracy of lymph node staging . Furthermore , a significant proportion of patients may be erroneously classified as histologically node negative Background Internationally , there is no consensus on the pathology protocol to be used to examine the sentinel lymph node ( SN ) . At present , therefore , various hospitals use different SN pathology protocol s of which the effect has not been fully eluci date d. We hypothesized that differences between hospitals in SN pathology protocol s affect subsequent surgical treatment strategies . Methods Patients from four hospitals ( A – D ) were prospect ively registered when they underwent an SN biopsy . In hospitals A , B , and C , three levels of the SN were examined pathologically , whereas in hospital D , at least seven additional levels were examined . In the absence of apparent metastases with hematoxylin and eosin examination , immunohistochemical examination was performed in all four hospitals . Results In total , 541 eligible patients were included . In hospital D , more patients were diagnosed with a positive SN ( P < .001 ) as compared with hospitals A , B , and C , mainly because of increased detection of isolated tumor cells . This led to more completion axillary lymph node dissections in hospital D ( 66.3 % of patients ( P < .0001 ) , compared with 29.0 % in hospitals A , B , and C combined ) . Positive non-SNs were detected in 13.9 % of patients in hospital D , compared with 9.7 % in hospitals A , B , and C ( P = .70 ) . That is , in 52.4 % of patients in hospital D , a negative completion axillary lymph node dissection was performed , compared with 19.3 % of patients in hospitals A , B , and C combined . Conclusions Differences in SN pathology protocol s between hospitals do have a substantial effect on SN findings and subsequent surgical treatment strategies . Whether ultrastaging and , thus , additional surgery can offer better survival remains to be determined PURPOSE To develop a guideline for the use of sentinel node biopsy ( SNB ) in early stage breast cancer . METHODS An American Society of Clinical Oncology ( ASCO ) Expert Panel conducted a systematic review of the literature available through February 2004 on the use of SNB in early-stage breast cancer . The panel developed a guideline for clinicians and patients regarding the appropriate use of a sentinel lymph node identification and sampling procedure from hereon referred to as SNB . The guideline was review ed by selected experts in the field and the ASCO Health Services Committee and was approved by the ASCO Board of Directors . RESULTS The literature review identified one published prospect i ve r and omized controlled trial in which SNB was compared with axillary lymph node dissection ( ALND ) , four limited meta-analyses , and 69 published single-institution and multicenter trials in which the test performance of SNB was evaluated with respect to the results of ALND ( completion axillary dissection ) . There are currently no data on the effect of SLN biopsy on long-term survival of patients with breast cancer . However , a review of the available evidence demonstrates that , when performed by experienced clinicians , SNB appears to be a safe and acceptably accurate method for identifying early-stage breast cancer without involvement of the axillary lymph nodes . CONCLUSION SNB is an appropriate initial alternative to routine staging ALND for patients with early-stage breast cancer with clinical ly negative axillary nodes . Completion ALND remains st and ard treatment for patients with axillary metastases identified on SNB . Appropriately identified patients with negative results of SNB , when done under the direction of an experienced surgeon , need not have completion ALND . Isolated cancer cells detected by pathologic examination of the SLN with use of specialized techniques are currently of unknown clinical significance . Although such specialized techniques are often used , they are not a required part of SLN evaluation for breast cancer at this time . Data suggest that SNB is associated with less morbidity than ALND , but the comparative effects of these two approaches on tumor recurrence or patient survival are unknown Background Routine axillary lymph node dissection ( ALND ) after selective sentinel lymphadenectomy ( SSL ) in the treatment of breast cancer remains controversial . We sought to determine the need for routine ALND by exploring the relationship between sentinel lymph node ( SLN ) and non-SLN ( NSLN ) status . We also report our experience with disease relapse in the era of SSL and attempt to correlate this with SLN tumor burden . Methods This was a retrospective study of 390 patients with invasive breast cancer treated at a single institution who underwent successful SSL from November 1997 to November 2002 . Results Of the 390 patients , 115 received both SSL and ALND . The percentage of additional positive NSLNs in the SLN-positive group ( 34.2 % ) was significantly higher than in the SLN-negative group ( 5.1 % ; P = .0004 ) . The SLN macrometastasis group had a significantly higher rate of positive NSLNs ( 39.7 % ) compared with the SLN-negative group ( 5.1 % ; P = .0001 ) . Sixteen patients developed recurrences during follow-up , including 6.1 % of SLN-positive and 3.3 % of SLN-negative patients . Among the SLN macrometastasis group , 8.7 % had recurrence , compared with 2.2 % of SLN micrometastases over a median follow-up period of 31.1 months . One regional failure developed out of 38 SLN-positive patients who did not undergo ALND . Conclusions ALND is recommended for patients with SLN macrometastasis because of a significantly higher incidence of positive NSLNs . Higher recurrence rates are also seen in these patients . However , the role of routine ALND in patients with a low SLN tumor burden remains to be further determined by prospect i ve r and omized trials BACKGROUND Examination was performed on pathologic material from patients enrolled in the National Surgical Adjuvant Breast Project ( NSABP ) protocol B-18 , in which the clinical effects of preoperative ( preop ) and postoperative ( postop ) doxorubicin and cyclophosphamide ( AC ) were compared . METHODS Of the total number of 1523 patients , 1234 patients ( 81 % ) were in the pathologically evaluable cohort . Six hundred twenty-six patients had been r and omized prospect ively to receive AC postop and 608 had been r and omized to receive AC preop . Preentry diagnosis was made by fine-needle aspiration ( FNA ) and /or Tru-cut biopsy ( TC ) . AC-induced and other pathologic changes were identified , and their relation to pathologic response and overall survival ( OS ) and disease-free survival ( DFS ) was determined . Frequencies of the number of lymph node metastases , their size , stromal reaction , and extracapsular extension ( ECE ) were compared in the two treatment groups , as was their correlation with OS and DFS . Survival estimates were based on 9 years of follow-up . RESULTS Approximately 13 % of primary breast carcinoma cases exhibited both a clinical complete response ( cCR ) and a pathologic complete response ( absence of invasive tumor [ pCR ] ) to preop AC . An additional 7 % of patients exhibited a pCR in the absence of a cCR . A pCR occurred in 38 % of those patients determined to have achieved a cCR . Poor nuclear grade of the tumor cells in the pre-entry FNA and /or TC specimens significantly predicted a pCR . Patients with the latter exhibited a better OS and DFS compared with those with a pathologic partial response ( presence of sparse invasive tumor [ pPR ] ) or no pathologic response ( pNR ) . Epithelial alterations considered to be induced in tumors by preop AC were comprised of types 1 and 2 giant cells with meganuclei , apocrine metaplasia , and cytoplasmic vacuolation . They had a high degree of specificity ( range , 86 - 99 % ) but a low sensitivity ( range , 7 - 38 % ) . All were predictive of a pPR and were found to be related adversely to OS and DFS . A fibrous stromal reaction noted in tumors or their putative sites in the preop group was found to have only modest degrees of specificity ( 63 % ) and sensitivity ( 74 % ) . Moderate/marked sclerosis of basement membranes of the ductal and ductular elements of the terminal ductolobular unit ( TDLU ) was significantly more frequent in nontumor-bearing areas of breasts from patients in the preop treatment group compared with those in the postop treatment group ( 67 % vs. 48 % ; P < 0.0001 ) . The degrees of change in the TDLU in patients in the postop treatment group were found to be unrelated to age . Lymphatic tumor extension in the primary tumor , as well as a positive lymph node status , were less frequent in the preop treatment group compared with the postop treatment group . The OS and DFS were nearly identical in both treatment groups , being 69 % and 55 % and 70 % and 53 % in the preop and postop treatment groups , respectively , at 9 years . A fibrous stromal response to lymph node metastases was found to be significant for DFS but not OS . ECE was similar in both groups ( 55 % vs. 48 % ; P = 0.12 ) . Only 1 % of ECE was found to be related to axillary failure in both treatment arms combined . There was no significant difference with regard to the parameters of survival for patients in the postop treatment group whose lymph nodes contained micrometastases ( < 2.0 mm ) or mini micrometastases ( < 1.0 mm ) ( the latter detected immunohistochemically with anticytokeratin ) , and a true-negative lymph node status ( not immunohistochemically converted to positive ) . Conversely , there was no apparent difference with regard to OS in preop treated patients with lymph node micrometastases , mini micrometastases , and macrometastases ( P = 0.19 ) . Those with mini micrometastases had a significantly worse OS compared with those with a true-negative lymph node status ( P = 0.0007 ) . DFS remained worse for patients in that treatment group with micrometastases and mini micrometastases compared with those with negative lymph nodes , although it was better than that for patients with macrometastases ( P = 0.02 ) . CONCLUSIONS Poor nuclear grade of tumor cells in the preentry FNA or TC specimens in the preop group was predictive of a pCR . AC-induced meganuclear giant cells and apocrine changes and nuclear and histologic grade s of the primary tumors also were found to be prognostically significant in patients in the preop treatment group , and the latter two variables were found to be significant for those patients in the postop treatment group . No evidence was found to support the need for axillary lymph node radiation for ECE of lymph node metastases . Extended pathologic or immunohistochemical procedures also appear to be unnecessary for the detection of lymph node mini micrometastases , at least when traditional postop chemotherapy is used . The adverse relation between such small metastases and OS and DFS after preop AC appears to be related to the timing of the chemotherapy administration rather than any pathobiologic reasons The current findings completely affirm the validity of our original observations indicating the appropriateness of grouping primary breast cancer patients into those with negative , 1 to 3 , or ≫4 positive nodes . Results , however , reveal that there is a risk in combining all patients with ≫4 positive nodes into a single group . Since there was a 25 % greater disease‐free survival and an 18 % greater survival in those with 4 to 6 than in those with ≫13 positive axillary nodes , such a unification may provide misleading information regarding patient prognosis , as well as the worth of a therapeutic regimen when compared with another from a putatively similar patient population . Of particular interest were findings relating the conditional probability , i.e. , the hazard rate , of a treatment failure or death each year during the 5‐year period following operation to nodal involvement with tumor . Whereas the hazard rate for those with negative , or 1 to 3 positive nodes , was relatively low and constant , in those with ≫4 positive nodes the risk in the early years was much greater , but by the fifth year it was similar to that occurring when 1‐3 nodes were involved , and not much different
Output:
| The presence ( vs the absence ) of metastases of 2 mm or less in diameter in axillary lymph nodes detected on single-section examination was associated with poorer disease-free and overall survival |
MS213558 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Osteoporotic compression fractures ( OVCFs ) commonly occur in aged people , and as much as one-third of these fractures progress to chronic pain . Kyphoplasty ( KP ) is proved to be efficacious for pain relief and vertebral height restoration in chronic OVCFs , but there is still no data available about the clinical and radiographical outcomes compared by unipedicular and bipedicular KP in treating chronic painful OVCFs . PURPOSE To assess the clinical and radiographical outcomes in treating chronic painful OVCFs compared by unipedicular and bipedicular KP . METHODS Fifty-eight patients with a total of sixty-six chronic painful OVCFs were enroled in our study . They were r and omly allocated into two groups : group I ( n=33 ) was treated with unipedicular KP and group II ( n=25 ) with bipedicular KP . The operation times for each group were recorded and compared . Preoperative and postoperative of visual analogue scores ( VAS ) and oswestry disability index ( ODI ) scores were compared 2 weeks after surgery within each group and between groups . The radiographic outcomes were evaluated by the restoration rate ( RR ) in the most compressed point of the vertebral bodies . RESULTS Significant improvement on the VAS , ODI scores and RR was noted in each group ( p<0.001 ) , and there is no significant difference existing in clinical outcomes between the two groups . The mean operation time for each vertebra in group I was significantly shorter than in group II ( p<0.001 ) . But the RR in group II was higher than in group I ( p=0.041 ) . CONCLUSION Both unipedicular kyphoplasty and bipedicular kyphoplasty can achieve satisfactory clinical and radiographic outcomes in treating the chronic painful OVCFs and the operation time is shorter in unipedicular kyphoplasty . However , the bipedicular kyphoplasty is more efficacious in height restoration Background : Percutaneous vertebroplasty ( PVP ) has been demonstrated to be effective in the treatment of acute osteoporotic vertebral fracture ( AOVF ) . However , the matter of which surgical approach should be selected remains controversial . This research aims to compare the clinical results of unilateral and bilateral PVP for AOVF . Methods : From January 2008 to December 2011 , 68 patients with AOVF were r and omly assigned to the unilateral puncture group ( n=36 ) or the bilateral group ( n=32 ) . These patients underwent percutaneous injection of polymethyl methacrylate into posterior pedicle by the unilateral or bilateral puncture approach . Visual analogue scale ( VAS ) and the Quality of Life Question naire of the European Foundation for Osteoporosis ( QUALEFFO ) were recorded on presentation , at 1 week , 3 , 6 , and 12 months after operation . The cement leakage was measured by x-ray and computed tomography scan . Results : Follow-up data showed there were no significant differences in VAS and QUALEFFO between 2 groups at 1 week after PVP and only significant difference was observed between 2 groups at 3 , 6 , and 12 months after operation . The cement leakage was 52.7 % in the unilateral puncture group and 28.1 % in the bilateral group . Conclusions : Compared with unilateral puncture , use of bilateral approach during PVP may result in more superior long-term outcomes and less cement leakage for patients with AOVF To assess the immediate efficacy of percutaneous vertebroplasty ( PVP ) in relief of pain and improving mobility of patients with vertebral compression fractures ( VCF ) secondary to osteoporosis , 205 cases ( 175 patients ) underwent 250 percutaneous injections of polymethylmethacrylate ( PMMA ; unilateral , 247 levels ; bilateral , 3 levels ) into vertebrae under CT and fluoroscopic guidance for 34 months . Patients were prospect ively asked to quantify their pain on a visual analog scale ( VAS ) before and a day after PVP . The interval to mobilization was recorded in those who were immobilized because of pain and /or bed-rest therapy ( 115 cases ) . PVP was technically successful in all patients , with three cases of minimal complications . The mean VAS score available for 196 cases was improved from 7.22±1.89 ( range , 3–10 ) to 2.07±1.19 ( range , 0–10 ) by PVP . Ninety-four of 115 immobilized cases ( 81.7 % ) were mobile by 24 h after PVP , and the mean value was 1.9±2.8 days . The incidence of recurrent and new fractures was 15.6 % in 4–25 months ( mean , 15.3 months ) . PVP is a safe and effective treatment for relieving the pain associated with osteoporotic VCF and strengthening the vertebrae , avoiding refractures . This therapy leads to early mobilization and avoidance of the dangers of conservative therapy of bed-rest OBJECTIVE To evaluate the clinical efficacy of percutaneous bipediculary kyphoplasty with double or single balloon I treatment of osteoporosis vertebral compressive fractures . METHODS Fifty-one patients with painful osteoporotic vertebral compressive fracture involving 69 vertebrae . 19 males and 32 females , aged 72.5 ( 63 - 85 ) , underwent percutaneous kyphoplasty with double inflatable balloon ( 29 cases , 38 vertebrae ) or single inflatable balloon ( 22 cases , 31 vertebrae ) under X-ray fluoroscopy monitoring . The fractured vertebral bodies were punctuated , balloon was put into the subsided areas and then distended , and bone cement was injected into the cavity . The vertebral height and Cobb angle , preoperative and postoperative , were measured by radiography . Follow-up was conducted for 6 - 12 months . RESULTS All patients tolerated the procedure well with dramatic pain relief within 96 hours after the procedure . No clinical complication was found . Visual analog scale score was improved from 7.8 preoperatively to 2.6 postoperatively ( P < 0.01 ) . Oswestry disability index was decreased from 73 % preoperatively to 26 % postoperatively . In the double balloon group , the heights loss of the anterior and middle portions of the vertebral body reduced from 14.7 mm and 10.5 mm to 10.1 mm and 5.5 mm respectively ( both P < 0.01 ) , and the Cobb angle was corrected from 22.4 degrees to 12.3 degrees ( P < 0.01 ) . In the single balloon group , the heights loss of the anterior and middle portions of the vertebral body reduced from 14.7 mm and 10.6 mm to 10.4 mm and 6.5 mm respectively ( both P < 0.01 ) , and the . Cobb angle was corrected averagely from 21.2 degrees to 11.6 degrees ( P < 0.01 ) . The mean vertebral height restoration rates were 72.8 % and 70.1 % in the double and single balloon groups respectively . The mean Cobb angle correct degrees were 10.1 degrees and 9.5 degrees in double and single balloon groups respectively . There were no significant differences in the average height restoration rate and Cobb angle correction between the double and single balloon groups ( 72.8 % vs 70.1 % , and 10.0 degrees vs 9.5 degrees both P > 0.05 ) . The pain relief and functional recovery were substantial and maintained to the last follow up . CONCLUSION Percutaneous bipediculary kyphoplasty with double or single balloon for painful osteoporotic vertebral body compressive fractures is effective and safe The Scottish Intercollegiate Guidelines Network ( SIGN ) develops evidence based clinical guidelines for the NHS in Scotl and . The key elements of the methodology are ( a ) that guidelines are developed by multidisciplinary groups ; ( b ) they are based on a systematic review of the scientific evidence ; and ( c ) recommendations are explicitly linked to the supporting evidence and grade d according to the strength of that evidence . Until recently , the system for grading guideline recommendations was based on the work of the US Agency for Healthcare Research and Quality ( formerly the Agency for Health Care Policy and Research ) . 1 2 However , experience over more than five years of guideline development led to a growing awareness of this system 's weaknesses . Firstly , the grading system was design ed largely for application to questions of effectiveness , where r and omised controlled trials are accepted as the most robust study design with the least risk of bias in the results . However , in many areas of medical practice r and omised trials may not be practical or ethical to undertake ; and for many questions other types of study design may provide the best evidence . Secondly , guideline development groups often fail to take adequate account of the method ological quality of individual studies and the overall picture presented by a body of evidence rather than individual studies or they fail to apply sufficient judgment to the overall strength of the evidence base and its applicability to the target population of the guideline . Thirdly , guideline users are often not clear about the implication s of the grading system . They misinterpret the grade of recommendation as relating to its importance , rather than to the strength of the supporting evidence , and may therefore fail to give due weight to low grade recommendations . # # # # Summary points A revised system of determining levels of evidence and grade s Purpose To investigate the effect of treatment of multiple myeloma (MM)-associated spinal fracture with percutaneous vertebroplasty ( PVP ) and chemotherapy . Methods Patients with MM-associated spinal fracture were r and omly divided into combined ( PVP and chemotherapy ) treatment group ( n = 38 ) and single chemotherapy group ( n = 38 ) . For the combined treatment group , bone cement was injected into vertebral body via DSA guided-percutaneous puncture . M2 scheme was used for both groups . And a 5-year follow-up was conducted for the study . Results At the 1-year follow-up visits , PVP combined with chemotherapy achieved complete remission ( CR ) in six patients ( 15.8 % ) ; near complete remission ( nCR ) in ten patients ( 26.30 % ) ; partial remission ( PR ) in nine patients ( 23.7 % ) ; minimal response ( MR ) in three patients ( 7.9 % ) ; no change ( NC ) in four patients ( 10.5 % ) , and disease progression ( DP ) in five patients ( 13.2 % ) . Only chemotherapy alone result ed in 3 CR ( 7.9 % ) ; 8 nCR ( 26.30 % ) ; 19 PR ( 77.5 % ) ; 4 MR ( 17.5 % ) ; 4 NC ( 17.5 % ) , and 2 DP ( 5.0 % ) . While the overall response rate ( ORR ) in the combined treatment group ( 65.8 % ) and the single chemotherapy group ( 50.0 % ) were significantly different , their visual analog pain scales ( 3.01 ± 0.62 and 5.97 ± 0.40 , respectively ) and Karnofsky performance scores ( 89.4 ± 6.3 and 80.3 ± 7.2 , respectively ) were significantly improved after treatment ( P = 0.032 and P = 0.002 , respectively ) . And the ORR between the two groups were significantly different ( P = 0.001 ) . Conclusion Percutaneous vertebroplasty is a minimally invasive surgery for MM-associated pathologic fracture . PVP had the characteristics of minimal trauma , easy operation and less complication . PVP can achieve long-term analgesic effect , and enhance the spinal stability Study Design . A prospect i ve study of patients who underwent multilevel balloon kyphoplasty at a single institute . Objective . To examine and compare the safety and long-term radiographic and clinical effects of unilateral or bilateral balloon kyphoplasty to treat multilevel symptomatic vertebral compression fractures . Summary of Background Data . Typically , balloon kyphoplasty involves placement of inflatable bone tamp via a bilateral transpedicular or extrapedicular approach . Recently , several articles reported unilateral kyphoplasty with comparable outcomes . However , few prospect i ve r and omized study comparing the radiographic and clinical outcomes using unilateral and bilateral approaches was reported . Methods . Forty-nine patients with 114 Osteoporotic vertebral compression fractures were r and omly allocated into two groups adopting unilateral or bilateral balloon kyphoplasty . Preoperative and postoperative pain scores , back disability , and 36-Item Short Form Health Survey scores were compared with at least a 2-year follow-up . Vertebral body height and vertebral body kyphotic angle from this cohort were analyzed before surgery , after surgery , and at final follow-up . Results . Both unilateral and bilateral balloon kyphoplasty result ed in significant pain reduction and back dysfunction improvement and remained unchanged at final follow-up . Quality of life assessment using 36-Item Short Form Health Survey recorded marked and significant improvements in all mean subscale scores except general health and social function . Regarding the pain reduction , back dysfunction , and 36-Item Short Form Health Survey scores , no significant difference existed between two groups . Significant increases of anterior and middle vertebral heights were recorded for both groups after surgery and maintained for the period of follow-up . The mean correction of vertebr
Output:
| There was no statistically significant difference in visual analog scale , vertebral height , kyphotic angular , and quality of life .
The main operative complications were bone cement leakage and adjacent vertebral fracture , without difference between the two groups .
In view of the current evidence , there is insufficient evidence to show any difference between the unilateral and bilateral approaches in both the PVP and PKP treatment in osteoporotic vertebral compression fractures . |
MS213559 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives The safety and efficacy of sirukumab , an anti-interleukin-6 ( IL-6 ) monoclonal antibody , were evaluated in a 2-part , placebo-controlled phase II study of patients with active rheumatoid arthritis ( RA ) despite methotrexate therapy . Methods In Part A ( proof-of-concept ) , 36 patients were r and omised to placebo or sirukumab 100 mg every 2 weeks ( q2w ) through week 10 , with crossover treatment during weeks 12–22 . In Part B ( dose finding ) , 151 patients were r and omised to sirukumab ( 100 mg q2w , 100 mg q4w , 50 mg q4w , or 25 mg q4w ) through week 24 , or placebo through week 10 with crossover to sirukumab 100 mg q2w ( weeks 12–24 ) . The proportion of patients with an American College of Rheumatology 50 ( ACR50 ) response and the change from baseline in the 28-joint count disease activity score using C-reactive protein ( DAS28-CRP ) were determined . Safety was evaluated through week 38 in both parts . Results The primary endpoint ( ACR50 at week 12 in Part B ) was achieved only with sirukumab 100 mg q2w versus placebo ( 26.7 % vs 3.3 % ; p=0.026 ) . Greater improvements in mean DAS28-CRP at week 12 were observed with sirukumab 100 mg q2w versus placebo in Parts A ( 2.1 vs 0.6 , p<0.001 ) and B ( 2.2 vs 1.1 ; p<0.001 ) . The incidence of adverse events ( AEs ) was similar for sirukumab-treated and placebo-treated patients through week 12 in Part A ( 70.6 % and 63.2 % , respectively ) and B ( 67.8 % and 66.7 % , respectively ) . Infections were the most common type of AE ; one death occurred ( Part B , sirukumab 100 mg q2w , brain aneurysm ) . Conclusions Sirukumab-treated patients experienced improvements in the signs/symptoms of RA . Safety results through 38 weeks were consistent with other IL-6 inhibitors . Trial registration number NCT00718718 CONTEXT Increased concentrations of inflammatory biomarkers predict antidepressant nonresponse , and inflammatory cytokines can sabotage and circumvent the mechanisms of action of conventional antidepressants . OBJECTIVES To determine whether inhibition of the inflammatory cytokine tumor necrosis factor ( TNF ) reduces depressive symptoms in patients with treatment-resistant depression and whether an increase in baseline plasma inflammatory biomarkers , including high-sensitivity C-reactive protein ( hs-CRP ) , TNF , and its soluble receptors , predicts treatment response . DESIGN Double-blind , placebo-controlled , r and omized clinical trial . SETTING Outpatient infusion center at Emory University in Atlanta , Georgia . PARTICIPANTS A total of 60 medically stable out patients with major depression who were either on a consistent antidepressant regimen ( n = 37 ) or medication-free ( n = 23 ) for 4 weeks or more and who were moderately resistant to treatment as determined by the Massachusetts General Hospital Staging method . INTERVENTIONS Three infusions of the TNF antagonist infliximab ( 5 mg/kg ) ( n = 30 ) or placebo ( n = 30 ) at baseline and weeks 2 and 6 of a 12-week trial . MAIN OUTCOME MEASURES The 17-item Hamilton Scale for Depression ( HAM-D ) scores . RESULTS No overall difference in change of HAM-D scores between treatment groups across time was found . However , there was a significant interaction between treatment , time , and log baseline hs-CRP concentration ( P = .01 ) , with change in HAM-D scores ( baseline to week 12 ) favoring infliximab-treated patients at a baseline hs-CRP concentration greater than 5 mg/L and favoring placebo-treated patients at a baseline hs-CRP concentration of 5 mg/L or less . Exploratory analyses focusing on patients with a baseline hs-CRP concentration greater than 5 mg/L revealed a treatment response ( ≥50 % reduction in HAM-D score at any point during treatment ) of 62 % ( 8 of 13 patients ) in infliximab-treated patients vs 33 % ( 3 of 9 patients ) in placebo-treated patients ( P = .19 ) . Baseline concentrations of TNF and its soluble receptors were significantly higher in infliximab-treated responders vs nonresponders ( P < .05 ) , and infliximab-treated responders exhibited significantly greater decreases in hs-CRP from baseline to week 12 compared with placebo-treated responders ( P < .01 ) . Dropouts and adverse events were limited and did not differ between groups . CONCLUSIONS This proof-of-concept study suggests that TNF antagonism does not have generalized efficacy in treatment-resistant depression but may improve depressive symptoms in patients with high baseline inflammatory biomarkers . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00463580 Rationale Premature discontinuation of antidepressant drugs is a frequent clinical problem . Adverse effects are common , occur early on in treatment and are reported to be one of the main reasons for discontinuation of antidepressant treatment . Objectives To investigate the association between adverse effects occurring in the first 2 weeks of antidepressant treatment and discontinuation by 6 weeks as the outcome . To investigate the time profile of adverse effects induced by the selective serotonin reuptake inhibitor citalopram and the noradrenaline reuptake inhibitor reboxetine over 12 weeks of treatment . Methods Six hundred and one depressed individuals were r and omly allocated to either citalopram ( 20 mg daily ) or reboxetine ( 4 mg twice daily ) . A modified version of the Toronto Side Effects Scale was used to measure 14 physical symptoms at baseline ( medication free ) and at 2 , 6 and 12 weeks after r and omisation . Results Individuals r and omised to reboxetine reported a greater number of adverse effects and were more likely to stop treatment than individuals receiving citalopram . Dizziness ( OR 1.83 ; 95 % CI 1.09 , 3.09 ; p = 0.02 ) and the total number of adverse effects ( OR 1.12 ; 95 % CI 1.00 , 1.25 ; p = 0.06 ) reported at 2 weeks were associated with discontinuation from overall antidepressant treatment by 6 weeks . Reports of adverse effects tended to reduce throughout the 12 weeks for both antidepressants . Conclusions The majority of adverse effects were not individually associated with discontinuation from antidepressant treatment . Reports of physical symptoms tended to reduce over time . The physical symptoms that did not reduce over time may represent symptoms of depression rather than antidepressant-induced adverse effects OBJECTIVE Major depressive disorder has been linked with inflammatory processes , but it is unclear whether individual differences in levels of inflammatory biomarkers could help match patients to treatments that are most likely to be beneficial . The authors tested the hypothesis that C-reactive protein ( CRP ) , a commonly available marker of systemic inflammation , predicts differential response to escitalopram ( a serotonin reuptake inhibitor ) and nortriptyline ( a norepinephrine reuptake inhibitor ) . METHOD The hypothesis was tested in the Genome-Based Therapeutic Drugs for Depression ( GENDEP ) study , a multicenter open-label r and omized clinical trial . CRP was measured with a high-sensitivity method in serum sample s from 241 adult men and women with major depressive disorder r and omly allocated to 12-week treatment with escitalopram ( N=115 ) or nortriptyline ( N=126 ) . The primary outcome measure was the score on the Montgomery-Åsberg Depression Rating Scale ( MADRS ) , administered weekly . RESULTS CRP level at baseline differentially predicted treatment outcome with the two antidepressants ( CRP-drug interaction : β=3.27 , 95 % CI=1.65 , 4.89 ) . For patients with low levels of CRP ( < 1 mg/L ) , improvement on the MADRS score was 3 points higher with escitalopram than with nortriptyline . For patients with higher CRP levels , improvement on the MADRS score was 3 points higher with nortriptyline than with escitalopram . CRP and its interaction with medication explained more than 10 % of individual-level variance in treatment outcome . CONCLUSIONS An easily accessible peripheral blood biomarker may contribute to improvement in outcomes of major depressive disorder by personalizing treatment choice OBJECTIVE Sirukumab ( CNTO 136 ) is a human mAb with high affinity and specificity for binding to interleukin-6 . This Phase 1 study evaluated the pharmacokinetics , immunogenicity , safety , and tolerability of sirukumab following a single subcutaneous ( s.c . ) administration in healthy male Japanese and Caucasian subjects . METHODS Japanese and Caucasian subjects were r and omized to placebo or 25 , 50 , or 100 mg sirukumab . Blood sample s were collected to measure serum sirukumab concentration and antibodies to sirukumab . Noncompartmental analysis and population pharmacokinetic modeling were conducted to characterize sirukumab pharmacokinetics . Adverse events were monitored at each visit . RESULTS 25 Japanese and 24 Caucasian subjects received sirukumab and were included in the pharmacokinetic evaluation . Mean Cmax and AUC0-∞of sirukumab increased in an approximately dose-proportional manner in both Japanese and Caucasian subjects . Median tmax was 3 -5 days after s.c . administration of sirukumab . Mean t1/2 was 15 -16 days in Japanese and 15 -18 days in Caucasian subjects . A one-compartment population pharmacokinetic model adequately described sirukumab pharmacokinetics following s.c . administration . The estimated population means for CL/F , V/F , and Ka were 0.54 ±0.03 l/day , 12.2 ±0.55 l , and 0.77 ±0.07 day-1 , respectively . Race was not a significant covariate on CL/F or V/F. No subject was positive for antibodies to sirukumab . Adverse events were generally mild and did not appear to be dose-related or lead to study discontinuation . CONCLUSIONS Sirukumab pharmacokinetics following subcutaneous administration was linear at doses ranging 25 -100 mg and was comparable between Japanese and Caucasian subjects . A single subcutaneous administration of 25 , 50 , or 100 mg sirukumab appeared to be well tolerated by both Japanese and Caucasian healthy male subjects In a controlled study , such immunological parameters as whole blood production of the cytokines interleukin-6 ( IL-6 ) and tumor-necrosis factor-α ( TNF-α ) were assessed in 24 in patients with a major depressive disorder ( MDD ) both before and again under treatment . After a 6-week treatment period with amitriptyline , patients were classified as responders or nonresponders according to their psychopathological outcome as evaluated by the Hamilton and the Montgomery – Asberg Depression Rating Scales . Pre-treatment levels of c-reactive protein ( CRP ) were significantly higher in both patient subgroups than in the control subjects . In comparison to the controls , unstimulated pretreatment production of IL-6 was significantly decreased in the responders ; whereas it was significantly increased in the nonresponder subgroup . Post-treatment values did not differ significantly among the patient and control groups . Pretreatment levels of TNF-α were increased in both patient subgroups , with a significant decrease during treatment only in the responder subgroup . Pretreatment levels of IL-6/105 mononuclear cells and the ratio between lymphocytes and monocytes acted as independent variables with regard to the clinical response . Our data indicate that unstimulated secretion of TNF-α is related to the psychopathological improvement ; whereas , IL-6 levels might dichotomize the patients into subsequent responders and nonresponders already at admission OBJECTIVE We undertook a 2-part , phase I , double-blind , placebo-controlled study to evaluate the safety and pharmacokinetics of multiple intravenous infusions of sirukumab , a human anti-interleukin-6 monoclonal antibody , in patients with cutaneous lupus erythematosus ( CLE ) or systemic lupus erythematosus ( SLE ) . METHODS In part A , patients with histologically confirmed CLE were r and omized to 4 infusions of placebo or 1 , 4 , or 10 mg/kg sirukumab every 2 weeks . In part B , SLE patients diagnosed according to American College of Rheumatology criteria with a score of 5 - 12 on the Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index were r and omized to 4 infusions of placebo or 10 mg/kg sirukumab every 2 weeks . RESULTS We
Output:
| Overall , sirukumab has been reported to be a safe and well-tolerated agent , capable of modulating the immune response in healthy population s as well as in subjects with inflammatory disorders ( e.g. , rheumatoid arthritis ) .
Amongst individuals with complex brain-based disorders ( e.g. , mood disorders ) , the dimensions/domains most likely to benefit with sirukumab are negative valence disturbances ( e.g. , anxiety , depression , rumination ) , positive valence disturbances ( e.g. , anhedonia ) as well as general cognitive processes .
We suggest that sirukumab represents a prototype and possibly a proof-of-concept that agents that engage IL-6 targets have salutary effects in psychiatry |
MS213560 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Low-salt ( LS ) diet activates the renin-angiotensin-aldosterone and sympathetic nervous systems , both of which can increase insulin resistance ( IR ) . We investigated the hypothesis that LS diet is associated with an increase in IR in healthy subjects . Healthy individuals were studied after 7 days of LS diet ( urine sodium < 20 mmol/d ) and 7 days of high-salt ( HS ) diet ( urine sodium > 150 mmol/d ) in a r and om order . Insulin resistance was measured after each diet and compared statistically , unadjusted and adjusted for important covariates . One hundred fifty-two healthy men and women , aged 39.1 ± 12.5 years ( range , 18 - 65 ) and with body mass index of 25.3 ± 4.0 kg/m(2 ) , were included in this study . Mean ( SD ) homeostasis model assessment index was significantly higher on LS compared with HS diet ( 2.8 ± 1.6 vs 2.4 ± 1.7 , P < .01 ) . Serum aldosterone ( 21.0 ± 14.3 vs 3.4 ± 1.5 ng/dL , P < .001 ) , 24-hour urine aldosterone ( 63.0 ± 34.0 vs 9.5 ± 6.5 μg/d , P < .001 ) , and 24-hour urine norepinephrine excretion ( 78.0 ± 36.7 vs 67.9 ± 39.8 μg/d , P < .05 ) were higher on LS diet compared with HS diet . Low-salt diet was significantly associated with higher homeostasis model assessment index independent of age , sex , blood pressure , body mass index , serum sodium and potassium , serum angiotensin II , plasma renin activity , serum and urine aldosterone , and urine epinephrine and norepinephrine . Low-salt diet is associated with an increase in IR . The impact of our findings on the pathogenesis of diabetes and cardiovascular disease needs further investigation Our recent studies have indicated that severe salt restriction aggravates vascular insulin resistance in younger normotensive and hypertensive subjects . However , whether the extent of dietary salt restriction commonly advocated adversely affects vascular insulin resistance is unknown . To determine whether moderate dietary salt restriction might affect vascular and systemic sensitivity to insulin , we studied eight subjects after 1 week of a normal sodium diet ( 235 mEq/day ) and 1 week of a moderate salt restriction ( 75 meq/day ) . Systemic insulin resistance as assessed by the fasting plasma glucose-to-insulin ratio was aggravated by dietary sodium restriction ( normal sodium : 1.2 + /- 0.1 mmol/mIU ; low sodium 0.6 + /- 0.1 , P < .05 ) . Salt restriction significantly reduced maximal insulin-mediated vasodilation ( normal sodium : 51 % + /- 5 % of maximum nitroglycerin-mediated response ; low sodium : 28 % + /- 6 % , P < .01 ) . In contrast , no alterations in nitroglycerin-mediated vasodilation nor phenylephrine-mediated vasoconstriction were noted . These studies demonstrate that moderate salt restriction aggravates both systemic and vascular insulin resistance . This impairment of the vasodilating effect of insulin could be a factor attenuating the blood pressure lowering effect of a low sodium diet To assess the effects of sodium reduction on insulin sensitivity in hypertension , we examined the change of insulin sensitivity after two degrees of dietary sodium restriction by the euglycemic hyperinsulinemic glucose clamp method in 12 subjects with primary hypertension . A controlled period of 1 week , when the subjects were taking a normal sodium diet , was followed by a r and omized crossover study in which the subjects were placed on either moderate or strict reduced sodium diets for 1 week . The result of the 1-week moderate dietary sodium reduction from 200 to 100 mmol/day showed significant decreases in systolic and diastolic blood pressure by 6.5 and 5.0 mm Hg , respectively . Strict dietary sodium reduction to 30 mmol/day for 1 week result ed in no further decrease in blood pressure , but it increased plasma insulin by 40.6 % without changing plasma glucose . There were no changes in glucose infusion rate ( GIR ) or insulin sensitivity index ( ISI ) , which is a measure of GIR divided by plasma insulin , after moderate dietary sodium reduction . However , strict dietary sodium reduction induced decreases in GIR by 19.8 % ( from 1318+/-189 to 1057+/-173 micromol/m2/ min ; P < .01 ) , and ISI by 20.5 % ( from 16.6+/-2.1 to 13.2+/-1.9 micromol/m2/min/microU/mL ; P < .01 ) with a paralleled increase of plasma norepinephrine by 90.0 % ( from 150.5+/-61.6 to 287.3+/-114.9 pg/mL ; P < .01 ) . These results indicate that dietary sodium restriction leads to a deterioration of insulin sensitivity when plasma norepinephrine levels increase , and suggest that moderate dietary sodium reduction may lower blood pressure without a distinct adverse effect on glucose metabolism in subjects with primary hypertension OBJECTIVES To investigate the relationship between salt sensitivity and hyperinsulinaemia in rural black African subjects . DESIGN An intervention study where 27 subjects were divided into two groups ; group 1 was initially salt loaded ( 300 mmol Na+/day ) , while group 2 was salt restricted ( 25 mmol Na+/day ) , each for 4 days , after which a cross-over study was done . SETTING Chidamoyo , a rural area 383 km north of Harare , Zimbabwe . SUBJECTS Twenty-seven rural volunteers ( 16 women , 11 men ) . OUTCOME MEASURES Systolic and diastolic blood pressures , salt sensitivity , insulin and glucose levels , body mass index and mean arterial pressure . RESULTS Mean arterial pressure , which was 91 + /- 2 mmHg on a low-salt diet , increased significantly ( P < 0.01 ) to 105 + /- 3 mmHg on high-salt diet in the salt-sensitive subjects . In the same salt-sensitive subjects , the fasting insulin level was 8.4 + /- 0.8 microU/ml on a low-salt and 6.1 + /- 1.0 microU/ml on a high-salt diet . The difference was not statistically significant . CONCLUSIONS Although salt pressor sensitivity was demonstrated in the subjects , there was no accompanying increase but rather a decrease in fasting insulin levels , suggesting that in the short term , salt sensitivity and hyperinsulinaemia are not linked in raising blood pressure in this sample of rural Zimbabwean subjects Dietary salt restriction lowers blood pressure and has been advocated as a population -based strategy to reduce the cardiovascular morbidity associated with hypertension . However , the effect of lowering salt intake on metabolic vascular risk factors such as insulin resistance and levels of atherogenic lipids and fasting insulin is uncertain . We have studied the short-term effect of moderate dietary salt restriction on insulin resistance and serum lipids in 34 nonobese ( body mass index [ mean + /- SD ] 23.4 + /- 1.8 kg/m2 ) , normotensive young white men . Subjects were maintained on a low salt diet ( < 80 mmol/day ) for the 2-week study period . In a r and omized , cross-over , double-blind fashion , each subject also received 120 mmol of sodium chloride per day during one of the study weeks , and a matching placebo during the other . Insulin resistance , serum insulin , lipids , and blood pressure were measured in the fasting state at the end of each study week . Urinary sodium excretion ( 185 + /- 46 v 52 + /- 25 mmol/day , P < .001 ) , serum sodium ( 141.2 + /- 1.2 v 140.1 + /- 1.3 mmol/L , P < .001 ) and body weight ( 75.4 + /- 9.1 v 75.0 + /- 9.3 kg , P < .05 ) were higher during the high salt than the low salt period . Serum creatinine was higher during the low salt period ( 100 + /- 8 v 90 + /- 9 mumols/L , P < .01 ) . There was no difference in blood pressure , insulin resistance , serum insulin , C-peptide , total cholesterol , low density lipoprotein cholesterol , high density lipoprotein cholesterol or its subfractions , triglycerides , apolipoprotein A1 , or apolipoprotein B between the high salt and low salt periods . We conclude that short-term , moderate dietary salt restriction does not adversely affect insulin sensitivity or levels of atherogenic lipids in normotensive nonobese men A case-control design involving only cases may be used when brief exposure causes a transient change in risk of a rare acute-onset disease . The design resembles a retrospective nonr and omized crossover study but differs in having only a sample of the base population -time . The average incidence rate ratio for a hypothesized effect period following the exposure is estimable using the Mantel-Haenszel estimator . The duration of the effect period is assumed to be that which maximizes the rate ratio estimate . Self-matching of cases eliminates the threat of control- selection bias and increases efficiency . Pilot data from a study of myocardial infa rct ion onset illustrate the control of within-individual confounding due to temporal association of exposures Insulin resistance was demonstrated in hypertensive patients and in salt-sensitive subjects . It was recently reported that the salt-sensitive state was related to a reduced fall in blood pressure during the night in essential hypertension . In the present study , the relationship among insulin sensitivity , blood pressure response to salt intake , and nocturnal fall in blood pressure was examined in 20 subjects with nondiabetic and nonobese essential hypertension during a low-salt and a high-salt diet . The subjects were maintained on a low-salt diet ( 50 mmol/d ) and a high-salt diet ( 255 mmol/d ) for 1 week each , in r and om order . On the sixth day of each diet , blood pressure was measured every hour for 24 hours with an automatic device . Insulin sensitivity was measured according to the steady-state plasma glucose ( SSPG ) method on the seventh day of each diet . Salt-induced increase in blood pressure , which we defined as the change in 24-hour mean arterial pressure between the low and the high dietary salt intakes , was significantly correlated with SSPG ( r=0.60 , P<0.01 ) during the high-salt period . There was a significant negative correlation ( r=-0.61 , P<0.01 ) between SSPG and a nocturnal fall in mean arterial pressure during the high-salt period . Salt-induced increase in blood pressure was inversely correlated with a nocturnal fall in mean arterial pressure ( r=-0.52 , P<0.02 ) with the high-salt diet . These results suggest that insulin resistance , salt sensitivity , and failed nocturnal fall in blood pressure are associated with each other in subjects with essential hypertension Evidence suggests that dietary salt reduction similar to diuretic therapy may adversely affect lipid and glucose metabolism . We studied 147 non-obese normotensive subjects ( 60 females and 87 males ) aged 19 - 78 years who entered a single-blind crossover trial and were r and omly assigned to a low salt diet of 20 mmol or a high salt diet of 300 mmol sodium per day , for 7 days each . Sodium restriction lowered mean arterial blood pressure ( MAP ) by a mean of 7.5 mmHg in 17 % ( salt-sensitive ) , had no hemodynamic effect in 67 % ( salt-resistant ) and raised MAP by a mean of 6 mmHg in 16 % of the subjects ( reverse reactors ) . With dietary salt restriction serum total- and LDL-cholesterol as well as serum insulin and uric acid concentrations increased significantly in all three groups . The largest increases in total ( 10 % ) and LDL- ( 12 % ) cholesterol occurred in the reverse reactors . Salt-sensitives had significant higher lipoprotein(a ) values than the other two groups . Salt-restriction had no significant effect on this parameter . Plasma renin activity , as well as plasma aldosterone and noradrenaline concentrations rose in all three groups during the low salt diet , the largest increases being observed in the reverse reactors . Short-term sodium restriction in normotensive adults has unfavourable effects on lipid and glucose metabolism , especially in subjects who do not derive hemodynamic benefit . Further studies are necessary to examine the effects of more moderate salt reduction for longer periods on the risk factor profile for cardiovascular disease before a low salt diet can be regarded as a safe public health measure for the general population We have previously reported that modest dietary sodium restriction , as advocated in management guidelines for diabetes ,
Output:
| Results differed little when the analyses were restricted to studies with a low risk of bias and duration of ≥7 d. CONCLUSIONS This meta- analysis revealed no evidence that , in trials with a short intervention and large reductions in sodium , circulating glucose concentrations differed between groups . |
MS213561 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: INTRODUCTION Healthy People 2010 seeks to eliminate racial and ethnic disparities in health care ; however , disparities due to age and race have been described in emergency department pain treatment . Although pain is a common patient complaint in emergency departments , many people receive no analgesia . This study examined the influence of patient and provider characteristics on ED and discharge analgesia and opioid prescribing practice s. METHODS This descriptive study used chart review of selected variables from ED patients 18 years and older who presented with musculoskeletal pain and were treated by core ED faculty . Logistic regression analyses were performed to determine whether analgesia- and opioid-prescribing disparities existed and were influenced by patient and provider characteristics . RESULTS A total of 868 patient records were examined . Physician characteristics and wide variation in practice were the only sources of disparities in the prescription of analgesics in the emergency department , but patient characteristics including race , age , chronic pain , and trauma influenced prescription of ED opioids and discharge analgesics . No gender or financial status disparities were found . Fewer opioids and discharge analgesics were prescribed for black patients than for white patients . Younger patients , those with trauma , and those with chronic pain received more opioids and discharge analgesics compared with older patients and those without trauma or chronic pain . Providers who completed emergency medicine residencies and had fewer than 3 years ' experience prescribed more analgesics in the emergency department . DISCUSSION Pain management in our emergency department is widely variable , with some disparities based on patient and physician characteristics . Multicenter prospect i ve studies are needed to vali date these findings and examine knowledge and attitude development about pain and its management . Protocol s for nurse-initiated analgesia may help improve and st and ardize ED pain care Context Studies documenting racial/ethnic disparities in health care frequently implicate physicians ’ unconscious biases . No study to date has measured physicians ’ unconscious racial bias to test whether this predicts physicians ’ clinical decisions . Objective To test whether physicians show implicit race bias and whether the magnitude of such bias predicts thrombolysis recommendations for black and white patients with acute coronary syndromes . Design , Setting , and Participants An internet-based tool comprising a clinical vignette of a patient presenting to the emergency department with an acute coronary syndrome , followed by a question naire and three Implicit Association Tests ( IATs ) . Study invitations were e-mailed to all internal medicine and emergency medicine residents at four academic medical centers in Atlanta and Boston ; 287 completed the study , met inclusion criteria , and were r and omized to either a black or white vignette patient . Main Outcome Measures IAT scores ( normal continuous variable ) measuring physicians ’ implicit race preference and perceptions of cooperativeness . Physicians ’ attribution of symptoms to coronary artery disease for vignette patients with r and omly assigned race , and their decisions about thrombolysis . Assessment of physicians ’ explicit racial biases by question naire . Results Physicians reported no explicit preference for white versus black patients or differences in perceived cooperativeness . In contrast , IATs revealed implicit preference favoring white Americans ( mean IAT score = 0.36 , P < .001 , one- sample t test ) and implicit stereotypes of black Americans as less cooperative with medical procedures ( mean IAT score 0.22 , P < .001 ) , and less cooperative generally ( mean IAT score 0.30 , P < .001 ) . As physicians ’ prowhite implicit bias increased , so did their likelihood of treating white patients and not treating black patients with thrombolysis ( P = .009 ) . Conclusions This study represents the first evidence of unconscious ( implicit ) race bias among physicians , its dissociation from conscious ( explicit ) bias , and its predictive validity . Results suggest that physicians ’ unconscious biases may contribute to racial/ethnic disparities in use of medical procedures such as thrombolysis for myocardial infa rct ion & NA ; Previous retrospective studies have suggested that patient demographics may influence analgesic administration . These studies have not taken physicians ’ impression of patient pain into account . This prospect i ve study investigates the influence of ( i ) physician impression of the degree of pain and ( ii ) patient demographics on the use of analgesic . A convenience sample of adults with non‐traumatic lower back pain was studied . Possible predictors of analgesic administration included physician pain scores ( assessed by visual analogue scale ) , patient ethnicity , gender , age , and insurance . These variables were tested individually and then using logistic regression . For the total of 91 patients enrolled , only physician pain scale was found to be associated with analgesic use . Median scores were 68 mm ( interquartile range=62–80 mm ) for those receiving treatment versus 48 mm ( interquartile range=30–58 mm ) for those who did not ( P<0.001 ) . This study therefore suggests that physician impression of patient pain rather than patient demographics influences analgesic use OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity BACKGROUND We have observed that many black and Hispanic patients receiving palliative care at a major urban teaching hospital are unable to obtain prescribed opioids from their neighborhood pharmacies . In this study , we investigated the availability of commonly prescribed opioids in New York City pharmacies . METHODS We surveyed a r and omly selected sample of 30 percent of New York City pharmacies to obtain information about their stock of opioids . For each pharmacy , U.S. Census estimates for 1997 were used to determine the racial and ethnic composition of the neighborhood ( defined as the area within a 0.4-km [ 0.25-mile ] radius of the pharmacy ) and the proportion of residents who were more than 65 years old . Data on robberies , burglaries , and arrests involving illicit drugs in 1997 were obtained for the precinct in which each pharmacy was located . We used a generalized linear model to examine the relation between the racial or ethnic composition of neighborhoods and the opioid supplies of pharmacies , while controlling for the proportion of elderly persons at the census-block level and for crime rates at the precinct level . RESULTS Pharmacists representing 347 of 431 eligible pharmacies ( 81 percent ) responded to the survey . A total of 176 pharmacies ( 51 percent ) did not have sufficient supplies of opioids to treat patients with severe pain . Only 25 percent of pharmacies in predominantly nonwhite neighborhoods ( those in which less than 40 percent of residents were white ) had opioid supplies that were sufficient to treat patients in severe pain , as compared with 72 percent of pharmacies in predominantly white neighborhoods ( those in which at least 80 percent of residents were white ) ( P<0.001 ) . CONCLUSIONS Pharmacies in predominantly nonwhite neighborhoods of New York City do not stock sufficient medications to treat patients with severe pain adequately OBJECTIVE To describe the patterns of opioid prescribing and the factors associated with reductions in the potency of patients ' analgesic medications at the time of hospital discharge . DESIGN Prospect i ve cohort . SETTING Two hundred forty-four patients ( 171 surgical and 73 nonsurgical ) hospitalized in an urban academic medical center who have experienced moderate or severe pain and who are taking opioid analgesics prior to discharge . OUTCOME Step-down ( or reduction ) in the potency of patients ' analgesic medication at the time of discharge . A step-down is defined as the analgesic medication that a patient is prescribed for outpatient analgesia at the time of discharge being less potent then the last pain medication administered to that patient just prior to hospital discharge . RESULTS Thirty-three percent of all patients had reductions in the potency of their opioid pain medication at the time of discharge ( 36 % for surgical and 26 % for nonsurgical patients ) . For nonsurgical patients , we found a trend toward Hispanic ethnicity being an independent risk factor for having a step-down in analgesic potency at discharge ( odds ratio [ OR ] : 3.7 , 95 % confidence interval [ CI ] : 0.9 - 14.9 ) . CONCLUSION Physicians frequently reduce the potency of hospitalized patients ' pain medications at discharge and Hispanic patients may be at increased risk of this occurring . Further research is needed to determine if the reductions in analgesic potency we observed are associated with poor posthospital pain outcomes UNLABELLED Little is known about physical barriers to adequate pain treatment for minorities . This investigation explored sociodemographic determinants of pain medication availability in Michigan pharmacies . A cross-sectional survey-based study with census data and data provided by Michigan community retail pharmacists was design ed . Sufficient opioid analgesic supplies was defined as stocking at least one long-acting , short-acting , and combination opioid analgesic . Pharmacies located in minority ( < or=70 % minority residents ) and white ( > or=70 % white residents ) zip code areas were r and omly selected by using a 2-stage sampling selection process ( response rate , 80 % ) . For the 190 pharmacies surveyed , most were located in white areas ( 51.6 % ) and had sufficient supplies ( 84.1 % ) . After accounting for zip code median age and stratifying by income , pharmacies in white areas ( odds ratio , 13.36 high income vs 54.42 low income ) and noncorporate pharmacies ( odds ratio , 24.92 high income vs 3.61 low income ) were more likely to have sufficient opioid analgesic supplies ( P < .005 ) . Racial differences in the odds of having a sufficient supply were significantly higher in low income areas when compared with high income areas . Having a pharmacy located near a hospital did not change the availability for opioid analgesics . Persons living in predominantly minority areas experienced significant barriers to accessing pain medication , with greater disparities in low income areas regardless of ethnic composition . Differences were also found on the basis of pharmacy type , suggesting variability in pharmacist 's decision making . PERSPECTIVE Michigan pharmacies in minority zip codes were 52 times less likely to carry sufficient opioid analgesics than pharmacies in white zip codes regardless of income . Lower income areas and corporate pharmacies were less likely to carry sufficient opioid analgesics . This study illustrates barriers to pain care and has public health implication UNLABELLED This study investigated the association between effectiveness of ED pain treatment and race of patients , race of providers , and the concordance of patient and provider race , with a prospect i ve , multicenter study of patients presenting to 1 of 20 US and Canadian EDs with moderate to severe pain . Primary outcome is a 2-point or greater reduction in pain intensity , measured with an 11-point verbal scale , considered the minimum clinical ly important reduction in pain intensity . A total of 776 patients were enrolled . The sample included 57 % female , 44 % white , 26 % black , and 26 % Hispanic . The physician was white in 85 % of encounters . Arrival pain score ( adjusted odds ratio , 1.14 ; 95 % CI 1.06 , 1.24 ) , receipt of any ED analgesia ( 1.59 ; 95 % CI 1.17 , 2.17 ) , and physician nonwhite race ( 1.68 ; 95 % CI 1.10 , 2.55 ) were significant predictors of clinical ly significant reduction in pain intensity in multivariate analysis . Nonwhite physicians achieved better pain control without using more analgesics . Future research should explore the determinants of this difference in patient response to pain treatment related to provider race including provider characteristics and training that were not measured in this study . This study provided no evidence supporting an effect of racial concordance on the primary outcome . PERSPECTIVE This article presents analysis of predictors of clinical ly important reduction in pain intensity among emergency department patients , finding non
Output:
| Our study quantifies the magnitude of analgesic treatment disparities in subgroups of minorities .
The treatment gap does not appear to be closing with time or existing policy initiatives . |
MS213562 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background —Considerable evidence implicates the proinflammatory cytokine CD40 lig and ( CD40L ) in atherosclerosis and accumulating data link type 1 and 2 diabetes , conditions associated with accelerated atherosclerosis , to inflammation . This study therefore evaluated the hypothesis that diabetic patients have elevated plasma levels of soluble CD40L ( sCD40L ) and that treatment with the insulin-sensitizing thiazolidinediones lowers this index of inflammation . Methods and Results —Subjects with type 1 ( n=49 ) or type 2 diabetes ( n=48 ) had higher ( P < 0.001 ) sCD40L plasma levels ( 6.56±3.27 and 6.67±2.90 ng/mL , respectively ) compared with age-matched control groups ( 1.40±2.21 and 1.32±2.68 ng/mL , respectively ) . Multiple regression analysis demonstrated a significant ( P < 0.001 ) association between plasma sCD40L and type 1 as well as type 2 diabetes , independent of total cholesterol , high-density lipoprotein cholesterol , low-density lipoprotein cholesterol , triglycerides , blood pressure , body mass index , gender , C-reactive protein , and soluble intracellular adhesion molecule-1 . Furthermore , in a pilot study , administration of troglitazone ( 12 weeks , 600 mg/day ) , but not placebo , to type 2 diabetics ( n=68 ) significantly ( P < 0.001 ) diminished sCD40L plasma levels by 29 % . The thiazolidinedione lowered plasma sCD40L in type 2 diabetic patients with long-st and ing disease ( > 3 years ) with or without macrovascular complications ( −34 % and −29 % , respectively ) as well as in type 2 diabetic patients with more recent ( <3 years ) onset of the disease ( −27 % ; all P < 0.05 ) . Conclusions —This study provides new evidence that individuals with type 1 or 2 diabetes have a proinflammatory state as indicated by elevated levels of plasma sCD40L . Troglitazone treatment of type 2 diabetic patients diminishes sCD40L levels , suggesting a novel antiinflammatory mechanism for limiting diabetes-associated arterial disease Reduced effectiveness of the most common antiplatelet drug , acetylsalicylic acid ( ASA , aspirin ) , in diabetes mellitus has been associated with a lowered platelet sensitivity to ASA and related to glycemic control in diabetic patients . Our objectives were ( a ) to monitor the chemical background of how chronic hyperglycemia affects platelet response to ASA in diabetes and ( b ) to study a chemical competition between the amount of bound acetyl residues and the extent of protein glycation in blood platelets . Using whole-blood impedance aggregometry and platelet function analyzer ( PFA-100 ) we observed a reduced platelet response to ASA in diabetic patients ( 14 % vs. 79 % for PFA-100 collagen-epinephrine occlusion time ) and an association between the index of glycemic control and platelet refractoriness to ASA ( rS=−0.378 ) . Impaired platelet response to ASA was related to enhanced platelet protein glycation ( 3.6±0.4 in diabetes vs. 2.3±0.4 µmol fructosamine/µg protein in control ) and reduced incorporation of acetyl residue into proteins of platelets from diabetic patients ( 47.4±2.0 in control vs. 33.1±0.7 µmol acetyl/µg protein in diabetic subjects ) . Incubation of blood platelets with increasing concentrations of glucose and ASA under in vitro conditions led to excessive modification in protein amino groups : glucose and ASA competed with each other in the course of nonenzymatic modifications , glycosylation , or acetylation , and their contributions to the occupancy of protein amino groups ( R2=0.22 for glucose , R2=0.43 for ASA ) were dependent upon the concentrations of glucose and ASA . Overall the effects of high glucose and high ASA on the overall occupancy of protein free amino groups are not additive . While at higher concentrations ASA overcomes the effects of hyperglycemia and retards glycation , high glucose makes acetylation less efficient , and therefore the result ant chemical modification becomes greatly reduced . In conclusion , diminished susceptibility of various platelet proteins and receptors on blood platelet membranes to acetylation and high ambient glucose might underlie the apparently differentiated sensitivity of blood platelets to ASA and determine platelet “ insensitivity to aspirin ” in diabetic Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Objective To determine whether aspirin and antioxidant therapy , combined or alone , are more effective than placebo in reducing the development of cardiovascular events in patients with diabetes mellitus and asymptomatic peripheral arterial disease . Design Multicentre , r and omised , double blind , 2 × 2 factorial , placebo controlled trial . Setting 16 hospital centres in Scotl and , supported by 188 primary care groups . Participants 1276 adults aged 40 or more with type 1 or type 2 diabetes and an ankle brachial pressure index of 0.99 or less but no symptomatic cardiovascular disease . Interventions Daily , 100 mg aspirin tablet plus antioxidant capsule ( n=320 ) , aspirin tablet plus placebo capsule ( n=318 ) , placebo tablet plus antioxidant capsule ( n=320 ) , or placebo tablet plus placebo capsule ( n=318 ) . Main outcome measures Two hierarchical composite primary end points of death from coronary heart disease or stroke , non-fatal myocardial infa rct ion or stroke , or amputation above the ankle for critical limb ischaemia ; and death from coronary heart disease or stroke . Results No evidence was found of any interaction between aspirin and antioxidant . Overall , 116 of 638 primary events occurred in the aspirin groups compared with 117 of 638 in the no aspirin groups ( 18.2 % v 18.3 % ) : hazard ratio 0.98 ( 95 % confidence interval 0.76 to 1.26 ) . Forty three deaths from coronary heart disease or stroke occurred in the aspirin groups compared with 35 in the no aspirin groups ( 6.7 % v 5.5 % ) : 1.23 ( 0.79 to 1.93 ) . Among the antioxidant groups 117 of 640 ( 18.3 % ) primary events occurred compared with 116 of 636 ( 18.2 % ) in the no antioxidant groups ( 1.03 , 0.79 to 1.33 ) . Forty two ( 6.6 % ) deaths from coronary heart disease or stroke occurred in the antioxidant groups compared with 36 ( 5.7 % ) in the no antioxidant groups ( 1.21 , 0.78 to 1.89 ) . Conclusion This trial does not provide evidence to support the use of aspirin or antioxidants in primary prevention of cardiovascular events and mortality in the population with diabetes studied . Trial registration Current Controlled Trials IS RCT N53295293 Observational epidemiological studies suffer from many potential biases , from confounding and from reverse causation , and this limits their ability to robustly identify causal associations . Several high-profile situations exist in which r and omized controlled trials of precisely the same intervention that has been examined in observational studies have produced markedly different findings . In other observational sciences , the use of instrumental variable ( IV ) approaches has been one approach to strengthening causal inferences in non-experimental situations . The use of germline genetic variants that proxy for environmentally modifiable exposures as instruments for these exposures is one form of IV analysis that can be implemented within observational epidemiological studies . The method has been referred to as ' Mendelian r and omization ' , and can be considered as analogous to r and omized controlled trials . This paper outlines Mendelian r and omization , draws parallels with IV methods , provides examples of implementation of the approach and discusses limitations of the approach and some methods for dealing with these OBJECTIVE We investigated in general practice the efficacy of antiplatelets and antioxidants in primary prevention of cardiovascular events in people with type 2 diabetes . RESEARCH DESIGN AND METHODS The Primary Prevention Project ( PPP ) is a r and omized , open trial with a two-by-two factorial design aim ed to investigate low-dose aspirin ( 100 mg/day ) and vitamin E ( 300 mg/day ) in the prevention of cardiovascular events in patients with one or more cardiovascular risk factors . The primary end point was a composite end point of cardiovascular death , stroke , or myocardial infa rct ion . A total of 1,031 people with diabetes in the PPP , aged > /=50 years , without a previous cardiovascular event were enrolled by 316 general practitioners and 14 diabetes outpatient clinics . RESULTS The PPP trial was prematurely stopped ( after a median of 3.7 years ) by the independent data safety and monitoring board because of a consistent benefit of aspirin compared with the control group in a population of 4,495 patients with one or more major cardiovascular risk factors . In diabetic patients , aspirin treatment was associated with a nonsignificant reduction in the main end point ( relative risk [ RR ] = 0.90 , 95 % CI 0.50 - 1.62 ) and in total cardiovascular events ( 0.89 , 0.62 - 1.26 ) and with a nonsignificant increase in cardiovascular deaths ( 1.23 , 0.69 - 2.19 ) . In nondiabetic subjects , RRs for the main end point , total cardiovascular events , and cardiovascular deaths were 0.59 ( 0.37 - 0.94 ) , 0.69 ( 0.53 - 0.90 ) , and 0.32 ( 0.14 - 0.72 ) , respectively . No significant reduction in any of the end points considered could be found with vitamin E in either diabetic or nondiabetic subjects . CONCLUSIONS Our data suggest a lower effect of primary prevention of cardiovascular disease ( CVD ) with low-dose aspirin in diabetic patients as opposed to subjects with other cardiovascular risk factors . If confirmed , these findings might indicate that the antiplatelet effects of aspirin in diabetic patients are overwhelmed by aspirin-insensitive mechanisms of platelet activation and thrombus formation , thus making the balance between benefits and harms of aspirin treatment unfavorable . Further large-scale trials investigating the role of aspirin in the primary prevention of CVD in diabetic patients are urgently needed BACKGROUND Despite treatment , there is often a higher incidence of cardiovascular complications in patients with hypertension than in normotensive individuals . Inadequate reduction of their blood pressure is a likely cause , but the optimum target blood pressure is not known . The impact of acetylsalicylic acid ( aspirin ) has never been investigated in patients with hypertension . We aim ed to assess the optimum target diastolic blood pressure and the potential benefit of a low dose of acetylsalicylic acid in the treatment of hypertension . METHODS 18790 patients , from 26 countries , aged 50 - 80 years ( mean 61.5 years ) with hypertension and diastolic blood pressure between 100 mm Hg and 115 mm Hg ( mean 105 mm Hg ) were r and omly assigned a target diastolic blood pressure . 6264 patients were allocated to the target pressure < or = 90 mm Hg , 6264 to < or = 85 mm Hg , and 6262 to < or = 80 mm Hg . Felodipine was given as baseline therapy with the addition of other agents , according to a five-step regimen . In addition , 9399 patients were r and omly assigned 75 mg/day acetylsalicylic acid ( Bamycor , Astra ) and 9391 patients were assigned placebo . FINDINGS Diastolic blood pressure was reduced by 20.3 mm Hg , 22.3 mm Hg , and 24.3 mm Hg , in the < or = 90 mm Hg , < or = 85 mm Hg , and < or = 80 mm Hg target groups , respectively . The lowest incidence of major cardiovascular events occurred at a mean achieved diastolic blood pressure of 82.6 mm Hg ; the lowest risk of cardiovascular mortality occurred at 86.5 mm Hg . Further reduction below these blood pressures was safe . In patients with diabetes mellitus there was a 51 % reduction in major cardiovascular events in target group < or = 80 mm Hg compared with target group < or = 90 mm Hg ( p for trend=0.005 ) . Acetylsalicylic acid reduced major cardiovascular events by 15 % ( p=0.03 ) and
Output:
| Limited subgroup analyses suggested that the effect of aspirin on major adverse cardiovascular events differed by baseline cardiovascular disease risk , medication compliance and sex ( P for interaction for all > 0.05).There was no significant reduction in the risk of myocardial infa rct ion , coronary heart disease , stroke , cardiovascular mortality or all-cause mortality .
Aspirin significantly reduced the risk of myocardial infa rct ion for a treatment duration of ≤ 5 years .
There was an increase in risk of major or gastrointestinal bleeding events , but estimates were imprecise and not significant . |
MS213563 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: This article describes the evaluation of a comprehensive school-based asthma management program in an inner-city , largely African-American school system . All 54 elementary schools ( combined enrollment 13,247 students ) from a single urban school system participated in this study . Schools were r and omly divided between immediate and delayed intervention programs . The intervention consisted of 3 separate educational programs ( for school faculty/staff , students with asthma , and peers without asthma ) and medical management for the children with asthma ( including an Individual Asthma Action Plan , medications , and peakflow meters ) . Children with asthma were identified using a case detection program and 736 were enrolled into the intervention study . No significant differences were observed in school absences , grade point average , emergency room visits , or hospitalizations between the immediate and delayed intervention groups . Significant increases in knowledge were observed in the immediate intervention group . This study of a school-based asthma management education and medical intervention program did not show any differences between the intervention and control groups on morbidity outcomes . Our experience leads us to believe that such measures are difficult to impact and are not always reliable . Future research ers should be aware of the problems associated with using such measures . In addition , connecting children with a regular source of health care in this population was difficult . More intensive methods of medical management , such as school-based health centers or supervised asthma therapy , might prove more effective in inner-city schools The present study investigated schools as an appropriate context for an intervention design ed to produce clinical and psychological benefits for children with asthma . A total of 193 out of 219 ( 88.1 % ) children with asthma ( aged 7–9 yrs ) from 23 out of 24 ( 95.8 % ) schools completed the study . Intervention schools received a staff asthma-training session , advice on asthma policy , an emergency β2-agonist inhaler with spacer and whole-class asthma workshops . Nonintervention schools received no asthma-related input . Intervention children required less general practitioner-prescribed preventer medication despite no differences in symptom control compared with the nonintervention asthmatic group . Increased peer knowledge of asthma may have mediated improved active quality of life in the intervention group , together with increased self-esteem in young females . Those females not receiving the intervention , but identified as being asthmatic within the classroom , and thus possibly stigmatised , reported decreased self-esteem . Lower self-esteem in young males was associated with pet ownership . No change was found in staff knowledge , the establishment of asthma policies or school absences which were low even before intervention . In conclusion , a whole-school intervention can improve the health of children with asthma when followed with support for all children but effects are likely to be modified by sex and the home environment A r and omized trial of an instructional method was conducted in which school nurses taught children asthma self-management principles and skills , including peak flow monitoring , in 20-min , individual sessions over an 8-week period . Thirty-six children participated . An intervention group of 18 children received the teaching sessions . A control group of 18 children received regular care by the nurses , but no teaching sessions . The sample included 64 % boys , 69 % African-Americans , and 69 % Medicaid recipients . The average age of subjects was 10.2 years . The two groups were demographically similar , but despite r and om assignment , the control group had a significantly earlier age of onset of asthma and tended to have had more asthma attacks in the preceding year . These factors were statistically controlled in outcome analyses . Results of group comparisons showed no significant differences in the number of postintervention emergency room visits and days absent from school . However , nurses reported that children who practice d breathing exercises had less anxiety during exacerbations , and the nurses ' knowledge of the children 's baseline peak expiratory flow rates facilitated care of the children . Nurses expressed the opinion that the individual sessions with students might be useful in motivating them to participate effectively in later group sessions . The intervention was well accepted by students , parents , and nurses . We believe that this intervention is promising as a practical , low-cost approach to enhancing children 's asthma self-management skills and warrants further testing in a larger sample , with the intervention conducted over a longer period Pediatric asthma rates are reaching epidemic proportions , adversely affecting children 's quality of life , educational potential , and health care costs , especially those in the inner city . This study evaluated the effectiveness of a school-based asthma case management ( CM ) approach with medically underserved inner-city children attending Memphis City schools . Fourteen elementary schools with high rates of asthma-related hospital utilization were grouped according to school size , percentage of children with asthma enrolled , and percentage of children eligible for free or reduced-price lunch . Schools were r and omized to either a nurse CM intervention or a usual care ( UC ) condition . The CM group included 115 students ; 128 students were in the UC group . A longitudinal design was used to follow students ' progress . Students were primarily African-American children diagnosed with asthma . In CM schools , nurse case managers conducted weekly group sessions incorporating the Open Airways curriculum , followed up on students ' school absences , and coordinated students ' asthma care with families , school personnel , and medical providers . In UC schools , students received routine school nursing services . CM students had fewer school absences than their counterparts in UC schools ( mean 4.38 vs 8.18 days , respectively ) and experienced significantly fewer emergency department visits ( p < .0001 ) and fewer hospital days ( p < .05 ) than UC students . No such differences existed before program initiation . Replication and follow-up in year 2 showed continued significant improvements . School-based nurse CM can achieve significant improvements in school attendance and medical utilization OBJECTIVE To measure the effect of an asthma intervention on the functional status and morbidity of children with undiagnosed asthma . STUDY DESIGN Data from a r and omized trial were used to compare outcomes at baseline and follow-up for children with undiagnosed and diagnosed asthma . We studied 510 symptomatic children with diagnosed asthma ( diagnosed ) and 299 children with symptoms but no diagnosis ( undiagnosed ) . Baseline functioning and morbidity were similar for undiagnosed and diagnosed patients classified as moderate-severe . RESULTS There were fewer undiagnosed reported allergies , seasonal symptoms , and other respiratory diagnoses ( all P < 0.01 ) . Among the moderate-severe , functional status , for example , symptom-days ( P = .02 ) , symptom-nights ( P < .01 ) , and days of restricted activity ( P < .01 ) , was significantly reduced at follow-up for the undiagnosed in the intervention group but not for undiagnosed control subjects . Findings were similar for children with diagnosed asthma . CONCLUSIONS Children with undiagnosed asthma were generally nonatopic , although some had symptoms at a level comparable to children with a diagnosis . The intervention successfully improved functional status for children with undiagnosed asthma as well as for children with diagnosed asthma . These results can be applied to ongoing discussion s related to case detection BACKGROUND Asthma diminishes the health-related quality of life for many school-aged children . This study sought to explore the effect of a School-Based Asthma Education Program ( SBAEP ) on quality of life . METHODS Children with asthma who attended grade s 1 - 5 at two selected schools were requested to participate in this pilot study . Participants at one school were provided with a SBAEP , those at another school ( control group ) were provided with written educational material about asthma . The children completed the Paediatric Asthma Quality of Life Question naire ( PAQLQ ) before and one month after the educational interventions . RESULTS There were clinical ly important improvements in the SBAEP group in quality of life , specifically in the symptom subdomain . CONCLUSIONS The " Air Force " SBAEP appears to result in a favourable trend in quality of life for children . A larger scale trial is required following revisions to the program Abstract Objective : To determine the effect of a peer led programme for asthma education on quality of life and related morbidity in adolescents with asthma . Design : Cluster r and omised controlled trial . Setting : Six high schools in rural Australia . Participants : 272 students with recent wheeze , recruited from a cohort of 1515 students from two school years ( mean age 12.5 and 15.5 years ) ; 251 ( 92.3 % ) completed the study . Intervention : A structured education programme for peers comprising three steps ( the “ Triple A Program ” ) . Main outcome measures : Quality of life , school absenteeism , asthma attacks , and lung function . Results : When adjusted for year and sex , mean total quality of life scores showed significant improvement in the intervention than control group . Clinical ly important improvement in quality of life ( > 0.5 units ) occurred in 25 % of students with asthma in the intervention group compared with 12 % in the control group ( P=0.01 ) . The number needed to treat was 8 ( 95 % confidence interval 4.5 to 35.7 ) . The effect of the intervention was greatest in students in year 10 and in females . Significant improvements occurred in the activities domain ( 41 % v 28 % ) and in the emotions domain ( 39 % v 19 % ) in males in the intervention group . School absenteeism significantly decreased in the intervention group only . Asthma attacks at school increased in the control group only . Conclusion : The triple A programme leads to a clinical ly relevant improvement in quality of life and related morbidity in students with asthma . Wider dissemination of this programme in schools could play an important part in reducing the burden of asthma in Aim : To evaluate the effectiveness of a programme of asthma clubs in improving quality of life in primary school children with asthma . Methods : A cluster r and omised intervention trial was undertaken in 22 primary schools within the urban area of south and east Belfast , Northern Irel and . Schools were r and omised in pairs to immediate or delayed groups . The study subjects comprised 173 children aged 7–11 years whose parents had notified the school of their asthma diagnosis . Children attended school based weekly clubs over an 8 week period . The main outcome measures were the interview administered Paediatric Quality of Life Question naire scores , ranging from 1 ( worst ) to 7 ( best ) , spirometry , and inhaler technique . Results : Over 15 weeks , small but non-significant improvements in the overall quality of life score ( mean 0.20 ; 95 % confidence interval ( CI ) −0.20 to 0.61 ) and in each of its three components , activity limitation ( 0.20 ; −0.43 to 0.84 ) , symptoms ( 0.23 ; −0.23 to 0.70 ) , and emotional function ( 0.17 ; −0.18 to 0.52 ) , were observed in the immediate compared with the delayed group . Inhaler technique at week 16 was markedly better in the immediate group , with 56 % having correct technique compared with 15 % in the delayed group . No significant effect of the intervention on spirometry results could be demonstrated . Conclusion : This primary school based asthma education programme result ed in sustained improvements in inhaler technique , but changes in quality of life scores were not significant OBJECTIVE To evaluate an asthma education program for children with asthma that is delivered in their school by certified asthma educators from a local hospital-based asthma center . STUDY DESIGN R and omized controlled trial . SETTING Twenty-six elementary schools located in a suburb of Toronto . PARTICIPANTS A total of 256 children in grade s 2 to 5 with asthma and their parents were r and omized to control and experimental groups . INTERVENTION Children in the experimental group received the " Roaring Adventures of Puff " asthma education program over the course of six weekly 1-h sessions . Those in the control group continued receiving usual care . MEASUREMENTS AND RESULTS Data collection involved measuring asthma quality of life , self-efficacy for managing asthma , school absenteeism , days of interrupted activity , health services use , and parental loss of time from work . Quality of life and self-efficacy data were collected from the children at baseline and 2 months . Telephone parental interviews conducted over 1 year were used to collect data on the remaining variables . Unpaired t test , analysis of variance , and chi2 test were used to determine whether differences existed between the groups . The results are reported as the mean + /- SD . The experimental group demonstrated higher scores than the control group for self-efficacy ( 3.6 + /- 0.7 vs 3.8 + /- 0.9 , respectively ; p < 0.05 ) and quality of life ( 5.0 + /- 1.4 vs 5.5 + /- 1.4 , respectively ; p < 0.05 ) . At 1 year , the experimental group demonstrated fewer mean urgent health-care visits ( 2.5 + /- 2.5 vs 1.7 + /- 1.9 visits per year , respectively ; p < 0.01 ) , days of missed school ( 4.3 + /- 5.7 vs 3.0 + /- 4.4 days per year , respectively ; p > 0.05 ) , and days of interrupted activity ( 9.1 + /- 10.5 vs 6.2 + /- 7.3 days per year ; p < 0.01 ) related to asthma than the control group . There were no differences between the groups for parental work absenteeism or scheduled asthma visits . CONCLUSION Providing an asthma education program to children in their school can significantly improve quality of life and reduce the burden of childhood asthma Our objective was to determine whether an asthma education program in schools would have 1 ) a direct impact on student knowledge and attitudes to asthma and quality of life of the students with asthma , 2 ) an indirect impact on teacher knowledge and attitudes to asthma and on school policies about
Output:
| : Although findings regarding effects of school-based asthma education programs on quality of life , school absences , and days and nights with symptoms were not consistent , our analyses suggest that school-based asthma education improves knowledge of asthma , self-efficacy , and self-management behaviors |
MS213564 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND & AIMS Interobserver differences in endoscopic assessment s contribute to variations in rates of response to placebo in ulcerative colitis ( UC ) trials . We investigated whether central ized review of images could reduce these variations . METHODS We performed a 10-week , r and omized , double-blind , placebo-controlled study of 281 patients with mildly to moderately active UC , defined by an Ulcerative Colitis Disease Activity Index ( UCDAI ) sigmoidoscopy score ≥2 , that evaluated the efficacy of delayed-release mesalamine ( Asacol 800-mg tablet ) 4.8 g/day . Endoscopic images were review ed by a single expert central reader . The primary outcome was clinical remission ( UCDAI , stool frequency and bleeding scores of 0 , and no fecal urgency ) at week 6 . RESULTS The primary outcome was achieved by 30.0 % of patients treated with mesalamine and 20.6 % of those given placebo , a difference of 9.4 % ( 95 % confidence interval [ CI ] , -0.7 % to 19.4 % ; P = .069 ) . Significant differences in results from secondary analyses indicated the efficacy of mesalamine . Thirty-one percent of participants , all of whom had a UCDAI sigmoidoscopy score ≥2 as read by the site investigator , were considered ineligible by the central reader . After exclusion of these patients , the remission rates were 29.0 % and 13.8 % in the mesalamine and placebo groups , respectively ( difference of 15 % ; 95 % CI , 3.5%-26.0 % ; P = .011 ) . CONCLUSIONS Although mesalamine 4.8 g/day was not statistically different from placebo for induction of remission in patients with mildly to moderately active UC , based on an intent-to-treat analysis , the totality of the data supports a benefit of treatment . Central review of endoscopic images is critical to the conduct of induction studies in UC ; Clinical Trials.gov Number , NCT01059344 Background : Patients with ulcerative colitis ( UC ) who are in clinical remission may still have underlying endoscopic inflammation , which is associated with inferior clinical outcomes . The goal of this study was to determine the prevalence of active endoscopic disease , and factors associated with it , in patients with UC who are in clinical remission . Methods : Prospect i ve observational study in a single center . Patients with UC in clinical remission ( by Simple Clinical Colitis Activity Index ) were enrolled prospect ively at the time of surveillance colonoscopy . Disease phenotype , endoscopic activity ( Mayo subscore ) , and histologic score ( Geboes ) were recorded , and blood was drawn for peripheral blood biomarkers . Results : Overall , 149 patients in clinical remission were prospect ively enrolled in this cohort ; 81 % had been in clinical remission for > 6 months , and 86 % were currently prescribed maintenance medications . At endoscopy , 45 % of patients in clinical remission had any endoscopic inflammation ( Mayo endoscopy subscore > 0 ) , and 13 % had scores > 1 . In a multivariate model , variables independently associated with a Mayo endoscopic score > 1 were remission for < 6 months ( P = 0.001 ) , white blood count ( P = 0.01 ) , and C-reactive protein level ( P = 0.009 ) . A model combining these 3 variables had a sensitivity of 94 % and a specificity of 73 % for predicting moderate-to-severe endoscopic activity in patients in clinical remission ( area under the curve , 0.86 ) . In an unselected subgroup of patients who had peripheral blood mononuclear cell messenger RNA profiling , GATA3 messenger RNA levels were significantly higher in patients with endoscopic activity . Conclusions : Duration of clinical remission , white blood count , and C-reactive protein level can predict the probability of ongoing endoscopic activity , despite clinical remission in patients with UC . These parameters could be used to identify patients who require intensification of treatment to achieve mucosal healing BACKGROUND AND AIMS The aim was to derive health state utility scores in ulcerative colitis ( UC ) by establishing the relationship between the physician-rated ulcerative colitis disease activity index ( UCDAI ) and a patient reported EQ-5D by statistically mapping the two instruments . METHODS In a r and omised controlled trial comparing oral plus enema mesalazine treatment with oral mesalazine treatment alone ( PINCE ) , UCDAI and EQ-5D scores were collected in parallel from patients with active UC . From these data , multinomial logistic regression was used to estimate response probabilities to each of the five domains of the EQ-5D index from assessment of UC disease severity using original and abbreviated ( no endoscopy ) versions of the UCDAI . Predicted EQ-5D responses were converted by Monte Carlo simulation to the EQ-5D index for predicting health-related quality of life ( HRQoL ) . The reliability of the algorithm was tested using UCDAI scores from a second mesalazine RCT ( PODIUM ) . RESULTS The abbreviated-UCDAI showed comparable explanatory performance to the full UCDAI . For patients in remission , mean utility was 0.939 , 0.944 , and 0.940U for PINCE(estimated ) , PINCE(observed ) , and PODIUM , respectively . Mild/moderate and relapsing cases showed mean utilities of 0.801 , 0.811 , and 0.775 , respectively ; whilst for those in severe relapse , the mean utilities were 0.630 , 0.700 and 0.660 units , respectively . The mean squared error between actual and predicted utilities from observations in PINCE was 0.019 . CONCLUSION Response mapping of UC activity to EQ-5D domains produced reliable estimates of patient-rated health state utility consistent with UCDAI rated severity . Comparing abbreviated-UCDAI and full UCDAI suggests that inclusion of endoscopy scores has limited predictive value in estimating patient One hundred forty-two patients with active colonic or ileocolonic Crohn 's disease were included in a multicenter prospect i ve study . Data collection included 28 clinical , biological , and endoscopic items ; the latter were recorded according to a st and ardized colonoscopic protocol ; a previously vali date d endoscopic index of severity was calculated . Oral prednisolone ( 1 mg/kg body wt per day ) was started and maintained until clinical remission and for at least 3 and at most 7 wk . A second clinical biological and endoscopic evaluation was then performed . At initial colonoscopy , mucosal lesions were , by decreasing order of frequency , superficial ulcerations , deep ulcerations , mucosal edema , erythema , pseudopolyps , aphthoid ulcers , ulcerated stenosis , and nonulcerated stenosis ( 93 % , 74 % , 48 % , 44 % , 41 % , 35 % , 10 % , 8 % , and 2 % of cases , respectively ) . No correlation was found between the clinical activity index and any of the endoscopical data ( lesion frequency and surface , endoscopic severity index ) . Ninety-two percent of patients underwent clinical remission within 7 wk of treatment . None of the 28 clinical biological and endoscopical items collected just before treatment could predict clinical response to steroids . Only 38 of the 131 patients in clinical remission were also in endoscopic remission . In conclusion , ( a ) the description and severity of colonoscopic lesions in active Crohn 's disease have been quantified ; ( b ) no correlation exists between clinical severity and nature , surface , or severity of endoscopic lesions ; ( c ) Oral prednisolone ( 1 mg/kg body wt per day ) induces a clinical remission in 92 % of patients within 7 wk ; ( d ) resistance to steroids can not be predicted from the data collected before treatment onset ; and ( e ) only 29 % of patients in clinical remission also achieve endoscopic remission A r and omized clinical trial was conducted to determine whether colonoscopy is useful in deciding how long to maintain steroid treatment in attacks of Crohn 's disease involving the colon . One hundred forty-seven patients with acute attacks of colonic or ileocolonic Crohn 's disease were treated by oral prednisolone , 1 mg.kg-1.day-1 ; 136 achieved clinical remission , but 96 of them still had active endoscopic lesions and were r and omized either to immediate start of steroid tapering ( group A ; n = 46 ) or to continued prednisolone treatment at the same dosage for 5 more weeks before steroid tapering was begun ( group B ; n = 50 ) . In the remaining 40 patients ( already in endoscopic remission , group C ) , steroid tapering was begun immediately . After prednisolone discontinuation , patients were followed up for 18 months or until clinical relapse . Prolongation of prednisolone therapy significantly improved the endoscopic scores in group B ( 30 % of endoscopic remission ) . The frequency of successful steroid weaning was almost identical in groups A and B ( 82 % and 80 % , respectively ) , as was the actuarially calculated relapse clinical rate after steroid withdrawal ( P = 0.22 ) . No factor predictive of clinical relapse could be found . The clinical course of patients in group C was similar to that of those in groups A and B. Overall , only 22 % of the 147 patients were still in clinical remission and off steroids 18 months after prednisolone discontinuation , outlining the need for maintenance therapy . In conclusion , for patients who have achieved clinical remission , adjustment of steroid treatment duration on the basis of endoscopy results is of no benefit , and the endoscopic aspect has no prognostic value ; thus , it appears unnecessary to repeat colonoscopy in such patients before steroid tapering is begun BACKGROUND Gut-selective blockade of lymphocyte trafficking by vedolizumab may constitute effective treatment for ulcerative colitis . METHODS We conducted two integrated r and omized , double-blind , placebo-controlled trials of vedolizumab in patients with active disease . In the trial of induction therapy , 374 patients ( cohort 1 ) received vedolizumab ( at a dose of 300 mg ) or placebo intravenously at weeks 0 and 2 , and 521 patients ( cohort 2 ) received open-label vedolizumab at weeks 0 and 2 , with disease evaluation at week 6 . In the trial of maintenance therapy , patients in either cohort who had a response to vedolizumab at week 6 were r and omly assigned to continue receiving vedolizumab every 8 or 4 weeks or to switch to placebo for up to 52 weeks . A response was defined as a reduction in the Mayo Clinic score ( range , 0 to 12 , with higher scores indicating more active disease ) of at least 3 points and a decrease of at least 30 % from baseline , with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 . RESULTS Response rates at week 6 were 47.1 % and 25.5 % among patients in the vedolizumab group and placebo group , respectively ( difference with adjustment for stratification factors , 21.7 percentage points ; 95 % confidence interval [ CI ] , 11.6 to 31.7 ; P<0.001 ) . At week 52 , 41.8 % of patients who continued to receive vedolizumab every 8 weeks and 44.8 % of patients who continued to receive vedolizumab every 4 weeks were in clinical remission ( Mayo Clinic score ≤2 and no subscore > 1 ) , as compared with 15.9 % of patients who switched to placebo ( adjusted difference , 26.1 percentage points for vedolizumab every 8 weeks vs. placebo [ 95 % CI , 14.9 to 37.2 ; P<0.001 ] and 29.1 percentage points for vedolizumab every 4 weeks vs. placebo [ 95 % CI , 17.9 to 40.4 ; P<0.001 ] ) . The frequency of adverse events was similar in the vedolizumab and placebo groups . CONCLUSIONS Vedolizumab was more effective than placebo as induction and maintenance therapy for ulcerative colitis . ( Funded by Millennium Pharmaceuticals ; GEMINI 1 Clinical Trials.gov number , NCT00783718 . ) BACKGROUND & AIMS Endoscopy limited to the rectosigmoid colon is the st and ard technique used to measure endoscopic healing in ulcerative colitis ( UC ) clinical trials . We evaluated whether rectosigmoidoscopy adequately measures UC activity in the more proximal colon . METHODS We analyzed data from a phase 2 , placebo-controlled study that evaluated the efficacy and safety of etrolizumab in patients with moderate to severely active UC who had not responded to st and ard therapy . Central readers determined Mayo Clinic endoscopic subscores ( MCSe ) and ulcerative colitis endoscopic index of severity ( UCEIS ) scores from the rectosigmoid and proximal colon in videos of 331 examinations performed at baseline , week 6 , and week 10 . Rates of endoscopic healing ( MCSe ≤ 1 , MCSe = 0 ) and scores from
Output:
| Many patients in endoscopic remission from UC have no rectal bleeding .
Normal stool frequency associates with endoscopic remission , but many patients have abnormal stool frequencies despite endoscopic remission . |
MS213565 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIM To determine the long-term efficacy of autologous bone marrow mononuclear cells ( BM-MNCs ) transplantation in terms of improving liver function and reducing complications in patients with decompensated cirrhosis . METHODS A total of 47 in patients with decompensated liver cirrhosis were enrolled in this trial , including 32 patients undergoing a single BM-MNCs transplantation plus routine medical treatment , and 15 patients receiving medical treatment only as controls . Forty-three of 47 patients were infected with hepatitis B virus . Bone marrow of 80 - 100 mL was obtained from each patient and the BM-MNCs suspension was transfused into the liver via the hepatic artery . The efficacy of BM-MNCs transplantation was monitored during a 24-mo follow-up period . RESULTS Liver function parameters in the two groups were observed at 1 mo after BM-MNCs transfusion . Prealbumin level was 118.3 ± 25.3 mg/L vs 101.4 ± 28.7 mg/L ( P = 0.047 ) ; albumin level was 33.5 ± 3.6 g/L vs 30.3 ± 2.2 g/L ( P = 0.002 ) ; total bilirubin 36.9 ± 9.7 mmol/L vs 45.6 ± 19.9 mmol/L ( P = 0.048 ) ; prothrombin time 14.4 ± 2.3 s vs 15.9 ± 2.8 s ( P = 0.046 ) ; prothrombin activity 84.3 % ± 14.3 % vs 74.4 % ± 17.8 % ( P = 0.046 ) ; fibrinogen 2.28 ± 0.53 g/L vs 1.89 ± 0.44 g/L ( P = 0.017 ) ; and platelet count 74.5 ± 15.7 × 10(9)/L vs 63.3 ± 15.7 × 10(9)/L ( P = 0.027 ) in the treatment group and control group , respectively . Differences were statistically significant . The efficacy of BM-MNCs transplantation lasted 3 - 12 mo as compared with the control group . Serious complications such as hepatic encephalopathy and spontaneous bacterial peritonitis were also significantly reduced in BM-MNCs transfused patients compared with the controls . However , these improvements disappeared 24 mo after transplantation . CONCLUSION BM-MNCs transplantation is safe and effective in patients with decompensated cirrhosis . It also decreases the incidence of serious complications Background & AimS earch for an effective therapy for patients with hepatitis B virus related acute-on-chronic liver failure ( HBV-ACLF ) remains an important issue . This study investigated the efficacy of umbilical cord-derived mesenchymal stem cell ( UC-MSC ) transplantation in patients with HBV-ACLF . Methods 45 consecutive entecavir-treated HBV-ACLF patients were prospect ively studied . Among these patients , 11 received both plasma exchange ( PE ) and a single transplantation of UC-MSCs ( group A ) , while 34 received only PE ( group B ) . The primary endpoint was survival at 24 months . Results Compared with group B , levels of albumin , alanine aminotransferase , aspartate aminotransferase , total bilirubin , direct bilirubin , prothrombin time ( PT ) , international normalized ratio ( INR ) and model for end-stage liver disease score in group A improved significantly at 4 weeks after transplantation ( p < 0.05 ) . Levels of albumin , PT and INR in group A were also markedly improved at 24 months ( p < 0.05 ) . Group A had significantly higher cumulative survival rate at 24 months ( 54.5 % v.s. 26.5 % , p = 0.015 by log rank test ) . Between the two groups , levels of creatinine , White blood cell , hemoglobin and platelet were similar . HBeAg loss and hepatocellular carcinoma incidence were similar at 24 months . Group assignment ( relative risk : 2.926 , 95%confidence interval : 1.043–8.203 , p = 0.041 ) was an independent predictor for survival at 24 months . Success rate of UC-MSC transplantation was 100 % in group A. No severe adverse event was observed in any patient . Conclusion UC-MSC transplantation is safe and effective for HBV-ACLF patients treated with PE and entecavir . It further improves the hepatic function and survival UNLABELLED Acute-on-chronic liver failure ( ACLF ) is characterized by acute decompensation ( AD ) of cirrhosis , organ failure(s ) , and high 28-day mortality . We investigated whether assessment s of patients at specific time points predicted their need for liver transplantation ( LT ) or the potential futility of their care . We assessed clinical courses of 388 patients who had ACLF at enrollment , from February through September 2011 , or during early ( 28-day ) follow-up of the prospect i ve multicenter European Chronic Liver Failure ( CLIF ) ACLF in Cirrhosis study . We assessed ACLF grade s at different time points to define disease resolution , improvement , worsening , or steady or fluctuating course . ACLF resolved or improved in 49.2 % , had a steady or fluctuating course in 30.4 % , and worsened in 20.4 % . The 28-day transplant-free mortality was low-to-moderate ( 6%-18 % ) in patients with nonsevere early course ( final no ACLF or ACLF-1 ) and high-to-very high ( 42%-92 % ) in those with severe early course ( final ACLF-2 or -3 ) independently of initial grade s. Independent predictors of course severity were CLIF Consortium ACLF score ( CLIF-C ACLFs ) and presence of liver failure ( total bilirubin ≥12 mg/dL ) at ACLF diagnosis . Eighty-one percent had their final ACLF grade at 1 week , result ing in accurate prediction of short- ( 28-day ) and mid-term ( 90-day ) mortality by ACLF grade at 3 - 7 days . Among patients that underwent early LT , 75 % survived for at least 1 year . Among patients with ≥4 organ failures , or CLIF-C ACLFs > 64 at days 3 - 7 days , and did not undergo LT , mortality was 100 % by 28 days . CONCLUSIONS Assessment of ACLF patients at 3 - 7 days of the syndrome provides a tool to define the emergency of LT and a rational basis for intensive care discontinuation owing to futility Human mesenchymal stem/stromal cells ( MSCs ) have been explored in a number of clinical trials as a possible method of treating various diseases . However , the effect of long-term cell expansion in vitro on physiological function and genetic stability is still poorly understood . In this study , MSC cultures derived from bone marrow and liver were evaluated for the presence of aberrant cells following long-term expansion . In 46 independent cultures , four batches of transformed MSCs ( TMCs ) were found , which were all beyond the culture period of five weeks . These aberrant cells were first identified based on the appearance of abnormal cytology and the acquirement of growth advantage . Despite common MSC markers being diminished or absent , TMCs remain highly susceptible to lysis by allogenic natural killer ( NK ) cells . When transplanted into immunodeficient mice , TMCs formed sarcoma-like tumors , whereas parental MSCs did not form tumors in mice . Using a combination of high-resolution genome-wide DNA array and short-t and em repeat profiling , we confirmed the origin of TMCs and excluded the possibility of human cell line contamination . Additional genomic duplication and deletions were observed in TMCs , which may be associated with the transformation event . Using gene and microRNA expression arrays , a number of genes were identified that were differentially expressed between TMCs and their normal parental counterparts , which may potentially serve as biomarkers to screen cultures for evidence of early transformation events . In conclusion , the spontaneous transformation of MSCs result ing in tumorigenesis is rare and occurs after relatively long-term ( beyond five weeks ) culture . However , as an added safety measure , cultures of MSCs can potentially be screened based on a novel gene expression signature Background : Chronic hepatitis B virus ( HBV ) infection may eventually lead to decompensated liver cirrhosis , which is a terminal illness . Objectives : The aim of this study was to investigate the therapeutic efficacy of autologous peripheral blood stem cell ( APBSC ) transplantation to improve portal vein hemodynamics in patients with HBV-related decompensated cirrhosis . Patients and Methods : This prospect i ve study included 68 hospitalized patients who were diagnosed with HBV-related decompensated cirrhosis . These patients were divided into two groups : the transplantation group included 33 patients , while the control group included 35 . Both groups received conventional medical treatment simultaneously , and APBSC transplantation was performed on the patients in the transplantation group . We evaluated the effects of APBSC transplantation on postoperative liver function using the following indices : total bilirubin , serum prothrombin and albumin , spleen size , and portal vein hemodynamics . Postoperatively , all of the patients were followed up at 24 , 36 , and 48 weeks . Results : The transplantation group had no serious reactions . Compared with the control group , albumin and prothrombin activity in the transplantation group was significantly improved at 24 , 36 , and 48 weeks after the procedure , and spleen length and portal vein diameter were substantially reduced at 48 weeks . The velocity of peak portal vein blood flow and mean maximum portal vein blood flow were greatly increased in the APBSC transplantation group at 36 and 48 weeks , respectively ; however , there was also decreased portal vein diameter , which reduced portal vein pressure in patients with HBV-related decompensated cirrhosis . Conclusions : APBSC transplantation greatly benefits HBV-linked decompensated cirrhosis patients and should be recommended in clinical practice Objectives Counseling patients with acute-on-chronic hepatitis B liver failure ( ACHBLF ) on their individual risk of short-term mortality is challenging . This study aim ed to develop a conditional survival estimate ( CSE ) for predicting individualized mortality risk in ACHBLF patients . Methods We performed a large prospect i ve cohort study of 278 ACHBLF patients from December 2010 to December 2013 at three participating medical centers . The Kaplan-Meier method was used to calculate the cumulative overall survival ( OS ) . Cox proportional hazard regression models were used to analyze the risk factors associated with OS . 4-week CSE at “ X ” week after diagnostic established were calculated as CS4 = OS(X+4)/OS(X ) . Results The actual OS at 2 , 4 , 6 , 8 , 12 weeks were 80.5 % , 71.8 % , 69.3 % , 66.0 % and 63.7 % , respectively . Using CSE , the probability of surviving an additional 4 weeks , given that the patient had survived for 1 , 3 , 5 , 7 , 9 weeks was 74 % , 86 % , 92 % , 93 % , 97 % , respectively . Patients with worse prognostic feathers , including MELD > 25 , Child grade C , age > 45 , HE , INR > 2.5 , demonstrated the greatest increase in CSE over time , when compared with the “ favorable ” one ( Δ36 % vs. Δ10 % ; Δ28 % vs. Δ16 % ; Δ29 % vs. Δ15 % ; Δ60 % vs. Δ12 % ; Δ33 % vs. Δ12 % ; all P < 0.001 ; respectively ) . Conclusions This easy-to-use CSE can accurately predict the changing probability of survival over time . It may facilitate risk communication between patients and physicians Human umbilical cord mesenchymal stem cells ( HUMSCs ) are highly proliferative and can be induced to differentiate into advanced derivatives of all three germ layers . Thus , HUMSCs are considered to be a promising source for cell-targeted therapies and tissue engineering . However there are reports on spontaneous transformation of mesenchymal stem cells ( MSCs ) derived from human bone marrows . The capacity for HUMSCs to undergo malignant transform spontaneously or via induction by chemical carcinogens is presently unknown . Therefore , we isolated HUMSCs from 10 donors and assessed their transformation potential either spontaneously or by treating them with 3-methycholanthrene ( 3-MCA ) , a DNA-damaging carcinogen . The malignant transformation of HUMSCs in vitro was evaluated by morphological changes , proliferation rates , ability to enter cell senescence , the telomerase activity , chromosomal abnormality , and the ability to form tumors in vivo . Our studies showed that HUMSCs from all 10 donors ultimately entered senescence and did not undergo spontaneous malignant transformation . However , HUMSCs from two of the 10 donors treated with 3-MCA displayed an increased prol
Output:
| It was found that multipotent cell transplantation was able to alleviate liver damage and improve liver function .
Multipotent cell transplantation can also enhance the short‐term and medium‐term survival rates of ACLF .
In conclusions , this study suggested that multipotent cell transplantation could be recommended as a potential therapeutic supplementary tool in clinical practice . |
MS213566 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background / Objectives : Caries and erosion are common diseases of the dental hard tissues . The influence of vegetarianism on the development of caries and erosion has scarcely been investigated in the past . The aim of the present study was to evaluate the influence of fruit consumption and topical fluoride application on the prevalence of caries and erosion in vegetarians . Subjects/ Methods : In 100 vegetarians and 100 nonvegetarians , a dental examination was performed . The indices for decayed , missing , filled teeth ( DMFT ) and surfaces ( DMFS ) were determined . DMFT and DMFS were subdivided into decayed teeth ( DT ) , filled teeth ( FT ) , decayed surfaces ( DS ) and filled surfaces ( FS ) . In addition , the hygiene index and the number of teeth with dental erosion ( DE ) , root caries ( RC ) and overhanging restoration margins ( ORM ) were recorded . A question naire assessed patients ’ eating habits , frequency of oral hygiene , dentist visits and topical fluoride application . For statistical analysis , unpaired t-test , Mann – Whitney test and Pearson ’s chi-square test were applied . Results : Vegetarians had significantly more DT ( P<0.001 ) , DS ( P<0.001 ) , more teeth with DE ( P=0.026 ) , RC ( P=0.002 ) and ORM ( P<0.001 ) than nonvegetarians . Daily consumption of fruits was significantly more prevalent ( P<0.001 ) , and topical fluoride application was less prevalent ( P<0.001 ) in vegetarians compared with nonvegetarians . In particular , fluoride-containing toothpaste ( P<0.001 ) and table salt ( P=0.039 ) were less frequently used in vegetarians . Conclusion : The presented data suggest that vegetarians have an increased risk for caries and erosion . Topical fluoride application was shown to be effective in preventing caries , but not in preventing erosion AIM The aim of this paper was to investigate the effects of fluorotherapy on the oral health of subjects who had been following a vegan diet ( lacking in meat and animal derivatives ) for a long period of time ( at least 1 year and 6 months ) . METHODS A preliminary study ( t0 ) evaluated 50 subjects , all from northern Italy and aged 24 - 60 years ( 28 male and 22 female ) who had been following a vegan diet for a minimum of 18 months to a maximum of 20 years , and compared them with a control group of 50 individuals following a Mediterranean diet . All vegan subjects showed oral changes such as white spots , lesions invisible to the naked eye and decreased salivary pH values ( ~5 - 6 ) . In a second study ( t1 ) , the 50 vegan subjects were r and omly divided into two subgroups of 25 . Subgroup SG1 underwent fluorotherapy with sodium fluoride ( Elmex fluoride gel ® 1.25 % ) administered once daily for 1 year . Subgroup SG2 served as controls and did not receive fluorotherapy . The following parameters were recorded before the start of fluorotherapy and again after 1 year : salivary pH ; Decayed , Missing , Filled teeth Index ; presence and location of white spots and lesions not visible to the naked eye ; Plaque Index , and Gingival Index . RESULTS In SG1 , larger lesions became smaller in diameter and small lesions disappeared , a statistically significant improvement compared with SG2 , despite the persistence of restricted eating habits and the oral hygiene conditions being similar to those at t0 . Salivary pH showed no significant change in either subgroup . CONCLUSION Daily application of a topical 1.25 % fluoride gel is effective in reducing the incidence of white spot lesions caused by a vegan diet
Output:
| There was inconsistent evidence for a link between following a vegetarian diet and dental caries or the number of natural teeth .
Conclusions Within the limitations of the present study , the findings suggest that following a vegetarian diet may be associated with a greater risk of dental erosion |
MS213567 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A prospect i ve r and omized double-blind placebo-controlled trial was conducted in 13 subjects to find out whether mifepristone treatment could facilitate termination of second trimester pregnancy by sulprostone . The women received either 600 mg oral mifepristone or placebo tablets 36 hours before the administration of intramuscular sulprostone 0.5 mg every 6 hours . The median interval between the administration of sulprostone and abortion in the mifepristone group ( 4.6 hours ) was significantly shorter than that in the placebo group ( 20 hours ) . The amount of sulprostone required was also significantly less in the mifepristone group . There was no significant difference in the incidence of side effects or analgesic requirement between the two groups . We conclude that oral mifepristone is useful in facilitating termination of second trimester pregnancies by sulprostone Objective To compare intramuscular ( IM ) prostagl and in 15 methyl-F2α ( 15M-PGE2α ) with prostagl and in E2 ( PGE2 ) vaginal suppositories for second-trimester abortion in terms of efficacy and side effects . Methods Fifty-one women were r and omized to receive either 15M-PGF2α IM injections or PGE2 intravaginal suppositories for second-trimester abortion . Efficacy and side effects of the two agents were analyzed by two-tailed t tests , x2 analysis with Fisher exact test , and survival analysis . Results The mean times to rupture of membranes , delivery of fetus , and delivery of placenta were significantly less for women receiving PGE2 vaginal suppositories . The cumulative abortion rate after 24 hours for the PGE,2 group was 96 % , compared with 69 % for the 15M-PGF2α group . Although there were few differences in side effects , the 15M-PGF2α group had significantly fewer headaches , fevers , and chills . Conclusion Intravaginal PGE2 is superior to IM 15M-PGF2α for second-trimester abortion Objective The aim of this r and omized prospect i ve study was to compare efficacy and side effects of saline moistened misoprostol with dry misoprostol , administered 800 μg intravaginally every 6 h up to a maximum of 3 doses in 24 h for second trimester pregnancy termination . Material s and methods A total of 81 women seeking termination of second trimester pregnancy ( 55 fetal death , 17 fetal structural anomaly , 5 chromosomal abnormality , 4 other reasons ) were r and omly assigned to one of two treatment groups : ( 1 ) intravaginal non-moistened ( dry ) misoprostol in group A ( n = 40 ) or ( 2 ) misoprostol moistened with 3 ml of saline in group B ( n = 41 ) . Results All of the patients in either group aborted within 48 h ( 100 % success rate ) . Delivery was achieved in a median ( interquartile range ) of 13 ( 40 ) h with the group A protocol and 12 ( 36 ) h with the group B protocol ( P = 0.652 ) . Delivery with first dose , delivery within 12 h and delivery within 24 h were similar ( P > 0.05 ) in group B ( 34.1 , 87.5 and 60 % , respectively ) and group A ( 25 , 82.9 , 46.3 , respectively ) . Both treatment regimens were tolerable and with similar side effects . Conclusion Misoprostol moistened with saline was not more effective than dry misoprostol for second trimester pregnancy termination OBJECTIVE To study the effect of mifepristone for priming and induction of second-trimester abortion in conjunction with a high-concentration oxytocin drip . STUDY DESIGN Prospect i ve , r and omized , placebo-controlled , pilot study . Thirty patients with 14 - 25 weeks ' gestational age abortion received either 600 mg of mifepristone or placebo in 3 identical capsules followed , 48 hours later , by a high-concentration oxytocin drip ( HCOD ) . RESULTS The mifepristone group showed significantly higher success rates as compared to the placebo group ( 92.3 % vs. 52.9 % , p<0.05 ) . The time interval to abortion ( from beginning of HCOD ) was also significantly shorter in the mifepristone group as compared to the placebo group ( 11.3 + /- 6.0 hours vs. 17.6 + /- 6.5 hours , p < 0.05 ) . Probability of success as calculated by the Kaplan-Meier method was found to be highly significant ( log rank test p = 0.001 ) . CONCLUSION Our results suggest that mifepristone is very effective for priming and induction of second-trimester abortion and shortens significantly the time interval to evacuation following HCOD BACKGROUND The pharmacokinetic parameters of four different routes of administration of a single dose of 400 microg of misoprostol were studied . METHODS A total of 40 women undergoing termination of pregnancy by suction evacuation was r and omized by computer model to receive 400 microg of misoprostol by one of four routes : ( i ) sublingual ( ii ) oral ( iii ) vaginal and ( iv ) vaginal with addition of water . Venous blood sample s were taken at 0 , 1 , 2 , 5 , 10 , 20 , 30 , 45 , 60 , 120 , 240 and 360 min after the administration of misoprostol . Misoprostol acid ( MPA ) was determined in serum sample s using gas chromatography/t and em mass spectrometry . RESULTS Sublingual misoprostol achieved the highest serum peak concentration ( Cmax ) ( 574.8 + /- 250.7 pg/ml ) of MPA and this was significantly higher than those in the other groups [ Oral : 287.6 + /- 144.3 pg/ml ( P < 0.01 ) , vaginal : 125.2 + /- 53.8 pg/ml ( P < 0.001 ) and vaginal with water : 162.8 + /- 57.1 pg/ml ( P < 0.001 ) ] . The time to peak concentration ( Tmax ) was similar in both the sublingual ( 26.0 + /- 11.5 min ) and oral groups ( 27.5 + /- 14.8 min ) and was significantly shorter than those in both vaginal groups . The area under the MPA concentration versus time curve up to 360 min in the sublingual group ( 743.7 + /- 291.2 pg.h/ml ) was significantly greater than those in oral ( 402.8 + /- 151.6 pg.h/ml , P < 0.05 ) and vaginal ( 433.7 + /- 182.6 pg.h/ml , P < 0.05 ) groups , but no significant difference was found between sublingual and vaginal administration if water ( 649.3 + /- 333.8 pg.h/ml ) was added . CONCLUSION The new sublingual route of administration of misoprostol demonstrated a great potential to be developed into a method of medical abortion It is known that when misoprostol is given at 200 microg every 3 h after mifepristone pretreatment , the vaginal route is more effective than the oral route . However , women prefer the oral route . This r and omized study was to test our hypothesis that oral misoprostol 400 microg is as effective as vaginal misoprostol 200 microg when given every 3 h in termination of second trimester pregnancy after priming with mifepristone . A total of 142 patients was r and omly assigned to group 1 ( 200 mg mifepristone + 400 microg oral misoprostol every 3 h up to five doses ) or group 2 ( 200 mg mifepristone + 200 microg vaginal misoprostol every 3 h up to five doses ) . The incidence of side-effects and the preference study were assessed through a st and ardized question naire during and after the abortion . For the oral group , both the incidence of diarrhoea ( 40.0 versus 23.2 % , P = 0.03 ) and the amount of drug used ( 1734 compared with 812 microg , P < 0.0001 ) were significantly higher than that of the vaginal group but the incidence of fever appeared to be lower ( not significant ) . There was no significant difference in complete abortion rate : 81.4 % in the oral group and 75.4 % in the vaginal group . The median induction-abortion interval was similar in the two groups ( 10.4 versus 10.0 h ) . The percentage of women who aborted in 24 h was also similar : 57/70 ( 81.4 % ) in the oral group and 58/69 ( 87.0 % ) in the vaginal group . Overall , 82.0 % of women preferred the oral route . Oral misoprostol ( 400 microg ) given every 3 h up to five doses , when combined with mifepristone , was as effective as the vaginal ( 200 microg ) route in second trimester termination of pregnancy . This regimen could also be offered to those women who found repeated vaginal administration unacceptable 9-Deoxo-16,16-dimethyl 9-methylene PGE2 was given as a vaginal suppository at 0 and 8 hours to 37 patients . Two different doses were given , a 75-mg and 60-mg dose . The larger dose achieved an 86 % abortion rate at 24 hours and for the smaller dose it was 53 % . When an intramuscular injection of 15-methyl PGF2 alpha Tham was added at 24 hours , the success rate was 91 % and 80 % at 36 hours . The incidence of gastrointestinal side effects were significantly reduced when compared to vaginal administration of either PGE2 or 15-methyl PGF2 alpha methyl ester . The incidence of temperature elevation was similar to that achieved with the use of vaginal PGE2 but higher than with the use of vaginal 15-methyl PGF2 alpha methyl ester We report the results of a large‐scale trial with mifepristonc ( RU 486 ) followed by the administration of a prostagl and in ( PG ) analogue for the medical termination of early pregnancy . Altogether , 16,173 patients from 300 centers were evaluated . 48 women ( 0.3 % ) were lost to follow‐up prior to , and 416 ( 2.6 % ) after the PG administration , and therefore the efficacy was evaluated in 15,709 women . Overall . the success rate was 95.3 % . with no statistical difference regarding the nature and dose of PG used . The median duration of bleeding was 8 days , being 12 days or less in 89.7 % of the women . Bleeding was significant cnough to necessitate a vacuum aspiration or a dilatation and curettage in 0.8 % of the cases . A blood transfusion was necessary in 0.1 % of the women ( 11 patients ) . Serious cardio‐vascular side‐effects were reported in 4 cases after the PG ( sulpro/tonc ) injection : they consisted of one acute myocardial infa rct ion attributed to a coronary spasm . and in marked hypotension in the other 3 woman . All patients recovered uneventfully . In conclusion , RU 486 followed by a PG analogue provides an efficient and safe medical alternative to surgery for early pregnancy termination , provided that the recommended protocol is adequately followed and the contraindications to prostagl and ins are respected OBJECTIVE The purpose of this study was to compare the efficacy and side effects of two different misoprostol regimens for second-trimester pregnancy termination . STUDY DESIGN We performed a r and omized clinical trial in patients who were at 14 to 23 weeks of gestation and who were admitted for medical termination of pregnancy . All patients received 800 microg of vaginal misoprostol and were assigned r and omly to 400 microg of oral misoprostol or 400 microg of vaginal misoprostol every 8 hours . Efficacy and side effects were compared . The mean induction time of the study group was compared with that of an historic control group that had received 400 microg vaginally every 12 hours . RESULTS Forty-three women were assigned r and omly , 22 women to vaginal misoprostol and 21 women to oral misoprostol . Induction time and hospital stay were slightly shorter for the oral group ; however , the differences were not significant . Side effects were similar for both groups . CONCLUSION After an initial 800 microg dose of vaginal misoprostol , a regimen of 400 microg of oral misoprostol every 8 hours is as effective as the same dose of vaginal misoprostol with no additional side effects , which provides a convenient alternative for midtrimester pregnancy termination Sixty patients were r and omized to low-dose and high-dose groups , receiving a maximum total dose 1400 g of misoprostol by the vaginal route to compare the efficacy of the protocol s for second trimester termination of pregnancy . Outcome measures to be compared between the groups were success rates , time to term
Output:
| When used alone , misoprostol was an effective inductive agent , though it appeared to be more effective in combination with mifepristone .
Misoprostol was preferably administered vaginally , although among multiparous women sublingual administration appeared equally effective .
No r and omised trials comparing doses of misoprostol were identified ; however low doses of misoprostol appear to be associated with fewer side-effects while moderate doses appear to be more efficient in completing abortion .
Indications for surgical evacuation include retained products of the placenta and heavy vaginal bleeding .
Medical abortion in the second trimester using the combination of mifepristone and misoprostol appeared to have the highest efficacy and shortest abortion time interval .
Where mifepristone is not available , misoprostol alone is a reasonable alternative .
Apart from pain , the side-effects of vaginal misoprostol are usually mild and self limiting . |
MS213568 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate A double-blind , placebo-controlled trial was carried out to determine the value of maintenance therapy with phenothiazines in a population of out patients who had recently recovered from an acute episode of schizophrenia . The drug was shown to be significantly more effective than the placebo in preventing relapse . The relationship of the trial patients to the population from which they were selected was defined in terms of clinical , historical , and social data . Maintenance therapy seems of little value in patients with a good prognosis and in the severely ill , but it is of value in the indeterminate group between these two extremes Objective To determine the cost utility of treating schizophrenic patients with olanzapine compared with other antipsychotics in a naturalistic outpatient setting . Methods The pan-European SOHO study is a 3-year , prospect i ve , outpatient , observational study of outcomes associated with antipsychotic treatment , focusing on olanzapine , in ten European countries . For the cost-utility analysis , healthcare re source use ( inpatient care , day care , outpatient psychiatric consultations and antipsychotic and concomitant medication use ) and EQ-5D data were collected at baseline and at 3 , 6 and 12 months . The perspective was that of the health service payer . UK healthcare unit costs ( year 2004 values ) were applied to the re source use data for the ten countries . UK population tariffs were applied to the EQ-5D data to determine utility values . An Epoch analysis was used to analyze the longitudinal data . Multivariate regression analyses that adjusted for baseline covariates were used to estimate the incremental cost and utility gains for patients treated with olanzapine compared with each of the other antipsychotics ( risperidone , quetiapine , amisulpride , clozapine and oral or depot typical antipsychotics ) . Results A total of 10 972 patients were enrolled at baseline , of which 9107 completed the 12-month study period . Treatment with olanzapine was more effective in terms of QALYs gained than all of the other antipsychotic treatments . Treatment with olanzapine dominated quetiapine and amisulpride . The incremental cost for olanzapine compared with risperidone was £ 226 per patient over 12 months and the incremental cost per QALY gained was £ 5156 , with bootstrap analyses showing 100 % of the replications falling below a £ 30 000 per QALY gained threshold . Compared with treatment with clozapine , olanzapine was found to be marginally more effective , at an additional cost of £ 13 per patient over 12 months and to have an incremental cost per QALY gained of £ 775 . Bootstrap analyses showed that 81 % of replications fell below a £ 30 000 per QALY gained threshold . Comparing olanzapine with oral and depot typical antipsychotics , the incremental cost was £ 849 and £ 1106 per patient over 12 months and the incremental cost per QALY gained was £ 15 696 and £ 23 331 , respectively . Bootstrap analyses showed that 98 % of the replications fell below a £ 30 000 per QALY gained threshold for the comparison with oral typical antipsychotics , and 79 % of replications for the comparison with depot preparations . Conclusions Among SOHO patients , if a funding threshold of £ 30 000 per QALY gained is assumed , this analysis suggests that olanzapine has a high probability of being the most cost-effective treatment compared with other antipsychotic treatments . However , comparison of olanzapine with clozapine and typical depot antipsychotics should be viewed with caution because clozapine is a second-line treatment and depot treatment is used for patients who do not adhere to their oral medication Because the importance of tranquilizing drugs has been difficult to assess precisely , the author undertook a study on the effect of the withdrawal of chlorpromazine and trifluoperazine on hospitalized male schizophrenics in Engl and . Although there were no major relapses among the placebo group , changes occurred that were sometimes disabling The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas BACKGROUND There are cl aims that the extra costs of atypical ( second-generation ) antipsychotic drugs over conventional ( first-generation ) drugs are offset by improved health-related quality of life . AIMS To determine the relative costs and value of treatment with conventional or atypical antipsychotics in people with schizophrenia . METHOD Cost-effectiveness acceptability analysis integrated clinical and economic r and omised controlled trial data of conventional and atypical antipsychotics in routine practice . RESULTS Conventional antipsychotics had lower costs and higher quality -adjusted life-years ( QALYs ) than atypical antipsychotics and were more than 50 % likely to be cost-effective . CONCLUSIONS The primary and sensitivity analyses indicated that conventional antipsychotics may be cost-saving and associated with a gain in QALYs compared with atypical antipsychotics The st and ard drug Stelazine ( STEL ) , at a dose of 50 mg/day , exhibited therapeutic activity significantly different from placebo ( PL ) activity on several variables , most notably BPRS , attesting to the sensitivity of the experiment . On the other h and , the investigational drug , loxapine ( LOX ) , in doses of 100 mg/day for four weeks , could be differentiated from PL as treatment in the described population on only one variable ( NGI-Imp . ) and one item of the BPRS . On several variables , positive trends were noted , but the differences from PL did not attain the critical values necessary for statistical significance at P smaller than 0.05 . One might speculate that the relatively short duration of treatment in this study might account for the difference between these disappointing results and the more gratifying results of a previous loxapine study in chronic long-term institutionalized schizophrenics with the same oral dose Twenty adult female schizophrenics were included in a double-blind , between-patient trial . Patients received either 20 mg . trifluoperazine or 150 mg . oxypertine daily in capsule form . The dose could be altered to 10 or 30 mg . trifluoperazine ( or 120 to 180 mg . oxypertine ) at the doctor 's discretion , still maintaining the double-blind discipline . The trial drugs were administered for six weeks , after a three-week period of placebo treatment . Ratings were made throughout the trial period and for four subsequent weeks , using the Wing ` A ' and Venables rating scales . Laboratory tests , including S.G.O.T. , S.P.G.T. , alkaline phosphatase , P.C.V. , E.S.R. haemoglobin , and total and differential white cell counts , were also carried out . The results of this trial do not suggest that oxypertine is superior to trifluoperazine in activating withdrawn schizophrenics . Significantly lower values for white cell count and haemoglobin were found in the oxypertine group . Side-effects , which comprised mainly vomiting , diarrhoea , dizziness and tremor , and were not clinical ly significant , were observed more frequently after administration of trifluoperazine than after oxypertine OBJECTIVES To determine the clinical and cost-effectiveness of different classes of antipsychotic drug treatment in people with schizophrenia responding inadequately to , or having unacceptable side-effects from , their current medication . DESIGN Two pragmatic , r and omised controlled trials ( RCTs ) were undertaken . The first RCT ( b and 1 ) compared the class of older , inexpensive conventional drugs with the class of new atypical drugs in people with schizophrenic disorders , whose current antipsychotic drug treatment was being changed either because of inadequate clinical response or owing to side-effects . The second RCT ( b and 2 ) compared the new ( non-clozapine ) atypical drugs with clozapine in people whose medication was being changed because of poor clinical response to two or more antipsychotic drugs . Both RCTs were four-centre trials with concealed r and omisation and three follow-up assessment s over 1 year , blind to treatment . SETTING Adult mental health setting s in Engl and . PARTICIPANTS In total , 227 participants aged 18 - 65 years ( 40 % of the planned sample ) were r and omised to b and 1 and 136 ( 98 % of the planned sample ) to b and 2 . INTERVENTIONS Participants were r and omised to a class of drug . The managing clinician selected the individual drug within that class , except for the clozapine arm in b and 2 . The new atypical drugs included risperidone , olanzapine , quetiapine and amisulpride . The conventional drugs included older drugs , including depot preparations . As in routine practice , clinicians and participants were aware of the identity of the prescribed drug , but clinicians were asked to keep their participating patient on the r and omised medication for at least the first 12 weeks . If the medication needed to be changed , the clinician was asked to prescribe another drug within the same class , if possible . MAIN OUTCOME MEASURES The primary outcome was the Quality of Life Scale ( QLS ) . Secondary clinical outcomes included symptoms [ Positive and Negative Syndrome Scale ( PANSS ) ] , side-effects and participant satisfaction . Economic outcomes were costs of health and social care and a utility measure . RESULTS Recruitment to b and 1 was less than anticipated ( 40 % ) and diminished over the trial . This appeared largely due to loss of perceived clinical equipoise ( clinicians progressively becoming more convinced of the superiority of new atypicals ) . Good follow-up rates and a higher than expected correlation between QLS score at baseline and at follow-up meant that the sample as recruited had 75 % power to detect a difference in QLS score of 5 points between the two treatment arms at 52 weeks . The recruitment to b and 2 was approximately as planned . Follow-up assessment s were completed at week 52 in 81 % of b and 1 and 87 % of b and 2 participants . B and 1 data showed that , on the QLS and symptom measures , those participants in the conventional arm tended towards greater improvements . This suggests that the failure to find the predicted advantage for new atypicals was not due to inadequate recruitment and statistical power in this sample . Participants reported no clear preference for either class of drug . There were no statistically significant differential outcomes for participants entering b and 1 for reasons of treatment intolerance to those entering because of broadly defined treatment resistance . Net costs over the year varied widely , with a mean of 18,850 pounds sterling in the conventional drug group and 20,123 pounds sterling in the new atypical group , not a statistically significant difference .
Output:
| Comparison between low and high-dose trifluoperazine with placebo from a single study provided equivocal evidence of effects .
Our results agree with existing evidence that compared to placebo , trifluoperazine is an effective antipsychotic for people with schizophrenia .
Furthermore , our review provides supportive evidence that trifluoperazine increases the risk of extrapyramidal adverse effects . |
MS213569 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: CONTEXT Criteria for potentially inappropriate medication use among elderly patients have been used in the past decade in large US epidemiological surveys to identify population s at risk and specifically target risk-management strategies . In contrast , in Europe little information is available about potentially inappropriate medication use and is based on small studies with uncertain generalizability . OBJECTIVE To estimate the prevalence and associated factors of potentially inappropriate medication use among elderly home care patients in European countries . DESIGN , SETTING , AND PARTICIPANTS Retrospective cross-sectional study of 2707 elderly patients receiving home care ( mean [ SD ] age , 82.2 [ 7.2 ] years ) representatively enrolled in metropolitan areas of the Czech Republic , Denmark , Finl and , Icel and , Italy , the Netherl and s , Norway , and the United Kingdom . Patients were prospect ively assessed between September 2001 and January 2002 using the Minimum Data Set in Home Care instrument . MAIN OUTCOME MEASURES Prevalence of potentially inappropriate medication use was documented using all expert panels criteria for community-living elderly persons ( Beers and McLeod ) . Patient-related characteristics independently associated with inappropriate medication use were identified with a multiple logistic regression model . RESULTS Combining all 3 sets of criteria , we found that 19.8 % of patients in the total sample used at least 1 inappropriate medication ; using older 1997 criteria it was 9.8 % to 10.9 % . Substantial differences were documented between Eastern Europe ( 41.1 % in the Czech Republic ) and Western Europe ( mean 15.8 % , ranging from 5.8 % in Denmark to 26.5 % in Italy ) . Potentially inappropriate medication use was associated with patient 's poor economic situation ( adjusted relative risk [ RR ] , 1.96 ; 95 % confidence interval [ CI ] , 1.58 - 2.36 ) , polypharmacy ( RR , 1.91 ; 95 % CI , 1.62- 2.22 ) , anxiolytic drug use ( RR , 1.82 ; 95 % CI , 1.51 - 2.15 ) , and depression ( RR , 1.29 ; 95 % CI , 1.06 - 1.55 ) . Negatively associated factors were age 85 years and older ( RR , 0.78 ; 95 % CI , 0.65 - 0.92 ) and living alone ( RR , 0.76 ; 95 % CI , 0.64 - 0.89 ) . The odds of potentially inappropriate medication use significantly increased with the number of associated factors ( P<.001 ) . CONCLUSIONS Substantial differences in potentially inappropriate medication use exist between European countries and might be a consequence of different regulatory measures , clinical practice s , or inequalities in socioeconomic background . Since financial re sources and selected patient-related characteristics are associated with such prescribing , specific educational strategies and regulations should reflect these factors to improve prescribing quality in elderly individuals in Europe ZusammenfassungZIELE DER STUDIE : 1 . Bestimmung der Prävalenz von Polypharmakotherapie und unangemessenem Arzneimittelgebrauch bei älteren internistischen Patienten in Österreich ; 2 . Einschätzung deren Bedeutung für das Auftreten von unerwünschten Arzneimittelwirkungen ; 3 . Suche nach Prädiktoren für das Auftreten von unerwünschten Arzneimittelwirkungen bei einer älteren Patienten population . METHOD IK : In einer monozentrischen Kohortenstudie wurden über 3 Monate alle neu aufgenommenen Patienten ≥ 75 Jahren eingeschlossen . Die Aufnahmemedikation wurde durch ein multidisziplinäres Team bestehend aus Krankenhausapothekern und Internisten auf ihre angemessene Anwendung hin analysiert und überprüft , ob eine unerwünschte Arzneimittelwirkung aufgetreten war . ERGEBNISSE : Es wurden insgesamt 543 Patienten analysiert ( Altersmedian 82 Jahre , 60,2 % Frauen ) . Die mittlere Medikamentenanzahl bei Aufnahme betrug 7,5 ± 3,8 . Frauen nahmen signifikant mehr Medikamente ein als Männer ( 7,8 vs. 6,8 , p = 0,013 ) . 58,4 % der Patienten erfüllten das gewählte Kriterium für Polypharmakotherapie ( > 6 Medikamente ) . Folgende Faktoren waren mit Polypharmakotherapie assoziiert : weibliches Geschlecht , Pflegebedürftigkeit , hohe Anzahl an Entlassungsdiagnosen und ein hoher Punktwert auf der Charlson Komorbiditäts-Skala . Verzichtbare Medikamente wurden bei 36,3 % aller Patienten gefunden , Medikamente , die für alte Menschen inadäquat sind , bei 30,1 % , Doppelverordnungen bei 7,6 % , Fehldosierungen bei 23,4 % und potenzielle Medikamenteninteraktionen bei 65,8 % . Unerwünschte Arzneimittelwirkungen wurden bei 97/543 Patienten gefunden ( 17,8 % ) . In 56,7 % der Fälle war die unerwünschte Arzneimittelwirkung Grund für die stationäre Aufnahme und bei 18,7 % war eine Arzneimittelinteraktion sehr wahrscheinlich an der Entstehung beteiligt . Risikofaktoren für unerwünschte Arzneimittelwirkungen waren weibliches Geschlecht , Polymorbidität , Niereninsuffizienz und unangemessener Arzneimittelverordnung . SCHLUSSFOLGERUNG : Polypharmakotherapie , unangemessene Verschreibung und unerwünschte Arzneimittelwirkungen sind bei älteren internistischen Patienten in dem untersuchten österreichischen Zentrum vergleichbar häufig wie in and eren westlichen Ländern . Zur Verbesserung der Arzneimittelsicherheit bei dieser Hochrisikogruppe erscheint uns eine bessere Verschreibungsqualität bedeutsamer als eine Verminderung der Medikamentenanzahl . Summary OBJECTIVE : The aim of the study was to assess the prevalence of polypharmacy and inappropriate drug use in elderly internal-medicine patients in one Austrian center and to define the impact of these and other identified predictors on the occurrence of adverse drug events . METHODS : All patients ≥ 75 years admitted to selected internal wards of a university hospital were included in a monocentric prospect i ve cohort study over a period of three months . The pre-admission medication of the patients was analyzed with respect to appropriateness by a multidisciplinary team consisting of pharmacists and physicians trained in internal medicine . The medication was evaluated for the occurrence of adverse drug events . RESULTS : A total of 543 patients were analyzed ( median age 82 years ; 60.2 % female ) . The mean number of drugs taken was 7.5 ± 3.8 , with women taking significantly more drugs than men ( 7.8 vs. 6.8 , P = 0.013 ) . Overall , 58.4 % of the patients fulfilled the given criteria for polypharmacy ( > 6 drugs ) . The following factors were associated with polypharmacy : female sex , need for nursing care , high number of discharge diagnoses and high Charlson comorbidity score . Unnecessary drugs were found prescribed in 36.3 % of all patients , drugs to avoid ( Beers criteria ) in 30.1 % , duplication in 7.6 % , wrong dosage in 23.4 % and possible drug-drug interactions in 65.8 % . Adverse drug events were identified in 17.8 % of the patients ( 97/543 ) , among whom the adverse drug event was the reason for hospital admission in 56.7 % of the cases and a drug-drug interaction was involved in 18.7 % . Risk factors for adverse drug events were female sex , polymorbidity , renal dysfunction and inappropriate prescribing . CONCLUSION : Polypharmacy , inappropriate prescribing and adverse drug events were highly prevalent in a cohort of elderly internal-medicine patients in Austria . To improve drug safety in this high-risk population , appropriate prescribing might be more important than simply reducing the number of prescribed drugs OBJECTIVES To determine whether a medication review by a specialized team would promote regimen changes in elders taking multiple medications and to measure the effect of regimen changes on monthly cost and functioning . DESIGN A r and omized-controlled trial . SETTING Health center ambulatory clinic . PARTICIPANTS Community-dwelling older adults taking five or more medications were assessed at baseline and 6 weeks . A medication-change intervention group of 57 elders was compared with a control group of 76 elder adults . INTERVENTION The primary intervention was a comprehensive review and recommended modification of a patient 's medication regimen . Changes were endorsed by each patient 's primary physician and discussed with each patient . MEASUREMENTS Measures were the Timed Manual Performance Test , Physical Performance Test , Functional Reach Assessment , subtests from the Wechsler Adult Intelligence Scale , a modified R and t Memory Test , the Center for Epidemiological Studies -Depression Scale , the Self-Rating Anxiety Scale , and the R and 36-item Health Survey 1.0 . Comorbidity was determined using the International Classification of Diseases , Ninth Revision , Clinical Modification . Medication usage was determined using brown bag review . RESULTS Intervention subjects decreased their medications by an average of 1.5 drugs . No differences in functioning were observed between groups . Intervention subjects saved an average $ 26.92 per month in wholesale medication costs ; control subjects saved $ 6.75 per month ( P<.006 ) . CONCLUSION Although the intervention significantly reduced the medications taken and monthly cost , most patients were resistant to reducing medications to the recommended level . Further study is needed to underst and patient resistance to reducing adverse polypharmacy and to devise better strategies for addressing this important problem in geriatric health . Greater focus on prescriber behavior is recommended OBJECTIVES to evaluate specialist geriatric input and medication review in patients in high-dependency continuing care . DESIGN prospect i ve , r and omised , controlled trial . SETTING two residential continuing care hospitals . PARTICIPANTS two hundred and twenty-five permanent patients . INTERVENTION patients were r and omised to either specialist geriatric input or regular input . The specialist group had a medical assessment by a geriatrician and medication review by a multidisciplinary expert panel . Regular input consisted of review as required by a medical officer attached to each ward . Re assessment occurred after 6 months . RESULTS one hundred and ten patients were r and omised to specialist input and 115 to regular input . These were comparable for age , gender , dependency levels and cognition . After 6 months , the total number of medications per patient per day fell from 11.64 to 11.09 in the specialist group ( P = 0.0364 ) and increased from 11.07 to 11.5 in the regular group ( P = 0.094 ) . There was no significant difference in mortality or frequency of acute hospital transfers ( 11 versus 6 in the specialist versus regular group , P = 0.213 ) . CONCLUSION specialist geriatric assessment and medication review in hospital continuing care result ed in a reduction in medication use , but at a significant cost . No benefits in hard clinical outcomes were demonstrated . However , qualitative benefits and lower costs may become evident over longer periods OBJECTIVE : To investigate actual cost and adverse effect outcomes associated with a pharmacotherapy consultation in ambulatory care patients receiving polypharmacy . METHODS : Patients receiving five or more chronic medications were r and omized to receive pharmacotherapy consultation or usual medical care . Outcomes measured were changes in drug costs , medical costs , and drug-related symptoms six months after the consultation . Data were analyzed with unpaired Student 's t-test for continuous data . χ2 Analysis was used for categorical data . Patients and physicians were surveyed about their perceptions of the consultations after the study period . RESULTS : Drug and medical costs did not differ before and after the consultation . More patients in the consultation group had adverse symptom scores improve by two or more points , and fewer had symptom scores worsen by two or more points than in the control group . Seventy percent of patients and 76 % of physicians believed that the consult was beneficial . CONCLUSIONS : Polypharmacy patients are the most likely to have drug-related problems and require intervention . Of all the interventions performed in this study , 73 % of the original problems were recognized only through a patient interview , suggesting that an interpersonal relationship remains critical to the provision of pharmaceutical care . Although patients and physicians see intuitive value in pharmaceutical care , pharmacists need to exert more energy in the direction of marketing the profession . Finally , there are numerous difficulties in measuring the benefits of these interventions , possibly making broad-based interventions in complicated patients too difficult to assess accurately . Future studies should focus on patients with limited , specific problems or on interventions with narrow goals Background Polypharmacy in the Swedish elderly population is currently a prioritised area of research with a focus on reducing the use of potentially inappropriate medications ( PIMs ) . Multi-professional interventions have previously been tested for their ability to improve drug therapy in frail elderly patients . Objective This study aim ed to assess a structured model for pharmacist-led medication review s in primary health care in southern Sweden and to measure its effects on numbers of patients with PIMs ( using the definition of the Swedish National Board of Health and Welfare )
Output:
| No effect of medication review was found on clinical outcomes ( mortality , hospital admissions/healthcare use , the number of patients falling , physical and cognitive functioning ) , except a decrease in the number of falls per patient .
Furthermore no effect was found on quality of life and evidence was inconclusive about the effect on economical outcome measures .
However , an effect was found on most drug-related problems : medication review result ed in a decrease in the number of drug-related problems , more changes in medication , more drugs with dosage decrease and a greater decrease or smaller increase of the number of drugs .
Conclusions An isolated medication review during a short term intervention period has an effect on most drug-related outcomes , minimal effect on clinical outcomes and no effect on quality of life .
No conclusion can be drawn about the effect on economical outcome measures . |
MS213570 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Oxidative stress , inflammation , and increased cholesterol levels are all mechanisms that have been associated with Alzheimer ’s disease ( AD ) pathology . Several epidemiologic studies have reported a decreased risk of AD with fish consumption . This pilot study was design ed to evaluate the effects of supplementation with omega-3 fatty acids alone ( ω-3 ) or omega-3 plus alpha lipoic acid ( ω-3 + LA ) compared to placebo on oxidative stress biomarkers in AD . The primary outcome measure was peripheral F2-isoprostane levels ( oxidative stress measure ) . Secondary outcome measures included performance on : Mini-Mental State Examination ( MMSE ) , Activities of Daily Living/Instrumental Activities of Daily Living ( ADL/IADL ) , and Alzheimer Disease Assessment Scale-cognitive subscale ( ADAS-cog ) . Thirty-nine AD subjects were r and omized to one of three groups : 1 ) placebo , 2 ) ω-3 , or 3 ) ω-3 + LA for a treatment duration of 12 months . Eighty seven percent ( 34/39 ) of the subjects completed the 12-month intervention . There was no difference between groups at 12 months in peripheral F2-isoprostane levels ( p = 0.83 ) . The ω-3 + LA and ω-3 were not significantly different than the placebo group in ADAS-cog ( p = 0.98 , p = 0.86 ) and in ADL ( p = 0.15 , p = 0.82 ) . Compared to placebo , the ω-3+LA showed less decline in MMSE ( p < 0.01 ) and IADL ( p= 0.01 ) and the ω-3 group showed less decline in IADL ( p < 0.01 ) . The combination of ω-3+LA slowed cognitive and functional decline in AD over 12 months . Because the results were generated from a small sample size , further evaluation of the combination of omega-3 fatty acids plus alpha-lipoic acid as a potential treatment in AD is warranted OBJECTIVES Docosahexaenoic acid ( DHA ; 22:6 n-3 ) and arachidonic acid ( AA ; 20:4 n-6 ) are important for development of the central nervous system in mammals . There is a growth spurt in the human brain during the last trimester of pregnancy and the first postnatal months , with a large increase in the cerebral content of AA and DHA . The fetus and the newborn infant depend on maternal supply of DHA and AA . Our hypothesis was that maternal intake of DHA during pregnancy and lactation is marginal and that high intake of this fatty acid would benefit the child . We examined the effect of supplementing pregnant and lactating women with very-long-chain n-3 polyunsaturated fatty acids ( PUFAs ; cod liver oil ) on mental development of the children , compared with maternal supplementation with long-chain n-6 PUFAs ( corn oil ) . METHODS The study was r and omized and double-blinded . Pregnant women were recruited in week 18 of pregnancy to take 10 mL of cod liver oil or corn oil until 3 months after delivery . The cod liver oil contained 1183 mg/10 mL DHA , 803 mg/10 mL eicosapentaenoic acid ( 20:5 n-3 ) , and a total of 2494 mg/10 mL summation operator n-3 PUFAs . The corn oil contained 4747 mg/10 mL linoleic acid ( 18:2 n-6 ) and 92 mg/10 mL alpha-linolenic acid ( 18:3 n-3 ) . The amount of fat-soluble vitamins was identical in the 2 oils ( 117 micro g/mL vitamin A , 1 micro g/mL vitamin D , and 1.4 mg/mL dl-alpha-tocopherol ) . A total of 590 pregnant women were recruited to the study , and 341 mothers took part in the study until giving birth . All infants of these women were scheduled for assessment of cognitive function at 6 and 9 months of age , and 262 complied with the request . As part of the protocol , 135 subjects from this population were invited for intelligence testing with the Kaufman Assessment Battery for Children ( K-ABC ) at 4 years of age . Of the 135 invited children , 90 came for assessment . Six children did not complete the examination . The K-ABC is a measure of intelligence and achievement design ed for children aged 2.5 years through 12.5 years . This multisubtest battery comprises 4 scales : Sequential Processing , Simultaneous Processing , Achievement ( not used in the present study ) , and Nonverbal Abilities . The Sequential Processing and Simultaneous Processing scales are hypothesized to reflect the child 's style of problem solving and information processing . Scores from these 2 scales are combined to form a Mental Processing Composite , which serves as the measure of intelligence in the K-ABC . RESULTS We received dietary information from 76 infants ( 41 in the cod liver oil group and 35 in the corn oil group ) , documenting that all of them were breastfed at 3 months of age . Children who were born to mothers who had taken cod liver oil ( n = 48 ) during pregnancy and lactation scored higher on the Mental Processing Composite of the K-ABC at 4 years of age as compared with children whose mothers had taken corn oil ( n = 36 ; 106.4 [ 7.4 ] vs 102.3 [ 11.3 ] ) . The Mental Processing Composite score correlated significantly with head circumference at birth ( r = 0.23 ) , but no relation was found with birth weight or gestational length . The children 's mental processing scores at 4 years of age correlated significantly with maternal intake of DHA and eicosapentaenoic acid during pregnancy . In a multiple regression model , maternal intake of DHA during pregnancy was the only variable of statistical significance for the children 's mental processing scores at 4 years of age . CONCLUSION Maternal intake of very-long-chain n-3 PUFAs during pregnancy and lactation may be favorable for later mental development of children Background : Intestinal damage and malabsorption caused by chronic environmental enteropathy are associated with growth faltering seen in infants in less-developed countries . Evidence has suggested that supplementary omega-3 ( n−3 ) long-chain PUFAs ( LC-PUFAs ) might ameliorate this damage by reducing gastrointestinal inflammation . LC-PUFA supplementation may also benefit cognitive development . Objective : We tested whether early n−3 LC-PUFA supplementation improves infant intestinal integrity , growth , and cognitive function . Design : A r and omized , double-blind , controlled trial [ 200 mg DHA and 300 mg EPA or 2 mL olive oil/d for 6 mo ] was conducted in a population of 172 rural Gambian infants aged 3–9 mo . The primary endpoints were anthropometric measures and gut integrity [ assessed by using urinary lactulose : mannitol ratios ( LMRs ) ] . Plasma fatty acid status , intestinal mucosal inflammation ( fecal calprotectin ) , daily morbidity , and cognitive development ( 2-step means-end test and an attention assessment ) were secondary endpoints . Results : PUFA supplementation result ed in a significant increase in plasma n−3 LC-PUFA concentrations ( P < 0.001 for both DHA and EPA ) and midupper arm circumference ( MUAC ) ( effect size : 0.31 z scores ; 95 % CI : 0.06 , 0.56 ; P = 0.017 ) at 9 mo of age . At 12 mo , MUAC remained greater in the intervention group , and we observed significant increases in skinfold thicknesses ( P ≤ 0.022 for all ) . No other significant differences between treatment groups were detected for growth or LMRs at 9 mo or for secondary outcomes . Conclusions : Fish-oil supplementation successfully increased plasma n−3 fatty acid status . However , in young , breastfed Gambian infants , the intervention failed to improve linear growth , intestinal integrity , morbidity , or selected measures of cognitive development . The trial was registered at www.is rct n.org as IS RCT N66645725 Abstract This trial investigated the efficacy of omega-3 polyunsaturated fatty acid ( n-3 PUFA ) treatment for improving depressive symptoms and cognitive performance in patients with coronary artery disease ( CAD ) participating in cardiac rehabilitation . Patients with CAD aged 45 to 80 years were r and omized to receive either 1.9-g/d n-3 PUFA treatment or placebo for 12 weeks . Depressive symptoms were measured using the Hamilton Depression Rating Scale ( HAM-D , primary outcome ) and the Beck Depression Inventory II ( BDI-II ) . Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , criteria were used to identify a depressive episode at baseline . Cognitive performance was measured using a st and ardized battery for vascular cognitive impairment . In 92 patients ( age , 61.7 ± 8.7 y ; 76 % male , 40 % depressed ; HAM-D , 6.9 ± 5.9 ; BDI-II , 12.3 ± 10.9 ; n = 45 n-3 PUFA , n = 47 placebo ) , depression decreased ( HAM-D , F3,91 = 2.71 and P = 0.049 ; BDI-II , F3,91 = 6.24 and P < 0.01 ) , and cognitive performance improved ( attention/processing speed , F1,91 = 5.57 , P = 0.02 ; executive function , F1,91 = 14.64 , P < 0.01 ; visuospatial memory , F1,91 = 4.01 , P = 0.04 ) over cardiac rehabilitation . Omega-3 PUFA treatment increased plasma eicosapentaenoic acid ( F1,29 = 33.29 , P < 0.01 ) and docosahexaenoic acid ( F1,29 = 15.29 , P < 0.01 ) concentrations but did not reduce HAM-D ( F3,91 = 1.59 , P = 0.20 ) or BDI-II ( F3,91 = 0.46 , P = 0.50 ) scores compared with placebo . Treatment did not improve cognitive performance ; however , n-3 PUFAs significantly increased verbal memory compared with placebo in a subgroup of nondepressed patients ( F1,54 = 4.16 , P = 0.04 ) . This trial suggests that n-3 PUFAs do not improve depressive and associated cognitive symptoms in those with CAD . The possible benefits of n-3 PUFAs for verbal memory may warrant investigation in well-powered studies Objective : To test the hypothesis that higher levels of red blood cell ( RBC ) docosahexaenoic acid ( DHA ) and eicosapentaenoic acid ( EPA ) have a protective association with domain-specific cognitive function in women aged 65 years and older . Methods : A total of 2,157 women with normal cognition enrolled in a clinical trial of postmenopausal hormone therapy were followed with annual cognitive testing for a median of 5.9 years . In this retrospective cohort study , we assessed the relationship between prer and omization RBC DHA + EPA levels and a ) cognitive measures at baseline , and b ) cognitive change over time . Endpoints were composite cognitive function and performance in 7 cognitive domains : fine motor speed , verbal memory , visual memory , spatial ability , verbal knowledge , verbal fluency , and working memory . Results : After adjustment for demographic , clinical , and behavioral characteristics , no significant ( p < 0.01 ) cross-sectional cognitive differences were found between women in the high and low DHA + EPA tertiles at the time of the first annual cognitive battery . In addition , no significant ( p < 0.01 ) differences were found between the high and low DHA + EPA tertiles in the rate of cognitive change over time . Conclusions : We did not find an association between RBC DHA + EPA levels and age-associated cognitive decline in a cohort of older , dementia-free women Depressive symptoms may increase the risk of progressing from mild cognitive impairment ( MCI ) to dementia . Consumption of n-3 PUFA may alleviate both cognitive decline and depression . The aim of the present study was to investigate the benefits of supplementing a diet with n-3 PUFA , DHA and EPA , for depressive symptoms , quality of life ( QOL ) and cognition in elderly people with MCI . We conducted a 6-month double-blind , r and omised controlled trial . A total of fifty people aged > 65 years with MCI were allocated to receive a supplement rich in EPA ( 1·67 g EPA + 0·16 g DHA/d ; n 17 ) , DHA ( 1·55 g DHA + 0·40 g EPA/d ; n 18 ) or the n-6 PUFA linoleic acid ( LA ; 2·2 g/d ; n 15 ) . Treatment allocation was by minimisation based on age , sex and depressive symptoms ( Geriatric Depression Scale , GDS ) . Physiological and cognitive assessment s , question naires and fatty acid composition of erythrocytes were obtained at baseline and 6 months (
Output:
| Results Current evidence indicates that n-3 LC-PUFAs administered during pregnancy or breastfeeding have no effect on the skills or cognitive development of children in later stages of development .
Evidence regarding the improvement of cognitive function during childhood and youth or in attention deficit/hyperactivity disorder is inconclusive .
Moreover , it is still unclear if n-3 LC-PUFAs can improve cognitive development or prevent cognitive decline in young or older adults |
MS213571 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To compare the adverse effects and treatment adherence between 2 months of rifampin plus pyrazinamide ( 2RZ ) and 6 months of isoniazid ( 6H ) . BACKGROUND Patients with silicosis in Hong Kong are at high risk of acquiring tuberculosis . A previous study showed that treatment with 6H reduced the risk of silico-tuberculosis by one half . METHOD Patients with silicosis and a Mantoux skin test reaction > or = 10 mm were r and omized to receive either 2RZ or 6H daily . Liver function testing was done monthly during the initial 2 months . The adverse effects and treatment adherence were compared between the two regimens . RESULTS Forty patients ( mean age , 61.6 + /- 9.1 years ) and 36 patients ( mean age , 57.6 + /- 9.7 years ) were r and omized to the 2RZ and 6H arms , respectively ( p > 0.05 ) [ + /- SD ] . Baseline characteristics were comparable . Nineteen patients in the 2RZ arm had peak alanine transaminase ( ALT ) levels > 1.5 times the upper limit of normal ( ULN ) in comparison with only five study subjects of the 6H arm ( 47.5 % vs 13.9 % , p < 0.01 ) . Fourteen patients ( 35 % ) in the 2RZ arm and 1 patient ( 2.8 % ) in the 6H arm had peak ALT levels more than five times the ULN ( p < 0.001 ) . Only seven patients had symptoms suggestive of hepatitis ; none of the patients had jaundice . All recovered after withholding treatment . In the 2RZ study arm , none of the baseline characteristics predicted hepatotoxicity . Other adverse effects were generally mild and comparable between both study arms . Treatment was stopped prematurely in 45 % and 36.1 % of patients in the 2RZ and 6H arms , respectively ( p = 0.43 ) . The main reasons were hepatotoxicity for the 2RZ arm and voluntary withdrawal after experiencing other minor adverse effects for the 6H arm . CONCLUSION A higher incidence of hepatotoxicity was associated with rifampin plus pyrazinamide than isoniazid in the treatment of latent tuberculosis infection among patients with silicosis in Hong Kong Background With the renewed emphasis to implement isoniazid preventive therapy ( IPT ) in Sub-Saharan Africa , we investigated the effect of IPT on immunological profiles among household contacts with latent tuberculosis . Methods Household contacts of confirmed tuberculosis patients were tested for latent tuberculosis using the QuantiFERON ® -TB Gold In-Tube ( QFN ) assay and tuberculin skin test ( TST ) . HIV negative contacts aged above 5 years , positive to both QFN and TST , were r and omly assigned to IPT and monthly visits or monthly visits only . QFN culture supernatants from enrolment and six months ’ follow-up were analysed for M.tb-specific Th1 , Th2 , Th17 , and regulatory cytokines by Luminex assay , and for M.tb-specific IgG antibody concentrations by ELISA . Effects of IPT were assessed as the net cytokine and antibody production at the end of six months . Results Sixteen percent of contacts investigated ( 47/291 ) were r and omised to IPT ( n = 24 ) or no IPT ( n = 23 ) . After adjusting for baseline cytokine or antibody responses , and for presence of a BCG scar , IPT ( compared to no IPT ) result ed in a relative decline in M.tb-specific production of IFN gamma ( adjusted mean difference at the end of six months ( bootstrap 95 % confidence interval ( CI ) , p-value ) -1488.6 pg/ml ( ( −2682.5 , −294.8 ) , p = 0.01 ) , and IL- 2 ( −213.1 pg/ml ( −419.2 , −7.0 ) , p = 0.04 ) . A similar decline was found in anti-CFP-10 antibody levels ( adjusted geometric mean ratio ( bootstrap 95 % CI ) , p-value ) 0.58 ( ( 0.35 , 0.98 ) , p = 0.04 ) . We found no effect on M.tb-specific Th2 or regulatory or Th17 cytokine responses , or on antibody concentrations to PPD and ESAT-6 . Conclusions IPT led to a decrease in Th1 cytokine production , and also in the anti CFP-10 antibody concentration . This could be secondary to a reduction in mycobacterial burden or as a possible direct effect of isoniazid induced T cell apoptosis , and may have implication s for protective immunity following IPT in tuberculosis-endemic countries . Trial registration IS RCT N registry , IS RCT N15705625 . Registered on 30th September 2015 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND Tuberculosis is epidemic among workers in South African gold mines . We evaluated an intervention to interrupt tuberculosis transmission by means of mass screening that was linked to treatment for active disease or latent infection . METHODS In a cluster-r and omized study , we design ated 15 clusters with 78,744 miners as either intervention clusters ( 40,981 miners in 8 clusters ) or control clusters ( 37,763 miners in 7 clusters ) . In the intervention clusters , all miners were offered tuberculosis screening . If active tuberculosis was diagnosed , they were referred for treatment ; if not , they were offered 9 months of isoniazid preventive therapy . The primary outcome was the cluster-level incidence of tuberculosis during the 12 months after the intervention ended . Secondary outcomes included tuberculosis prevalence at study completion . RESULTS In the intervention clusters , 27,126 miners ( 66.2 % ) underwent screening . Of these miners , 23,659 ( 87.2 % ) started taking isoniazid , and isoniazid was dispensed for 6 months or more to 35 to 79 % of miners , depending on the cluster . The intervention did not reduce the incidence of tuberculosis , with rates of 3.02 per 100 person-years in the intervention clusters and 2.95 per 100 person-years in the control clusters ( rate ratio in the intervention clusters , 1.00 ; 95 % confidence interval [ CI ] , 0.75 to 1.34 ; P=0.98 ; adjusted rate ratio , 0.96 ; 95 % CI , 0.76 to 1.21 ; P=0.71 ) , or the prevalence of tuberculosis ( 2.35 % vs. 2.14 % ; adjusted prevalence ratio , 0.98 ; 95 % CI , 0.65 to 1.48 ; P=0.90 ) . Analysis of the direct effect of isoniazid in 10,909 miners showed a reduced incidence of tuberculosis during treatment ( 1.10 cases per 100 person-years among miners receiving isoniazid vs. 2.91 cases per 100 person-years among controls ; adjusted rate ratio , 0.42 ; 95 % CI , 0.20 to 0.88 ; P=0.03 ) , but there was a subsequent rapid loss of protection . CONCLUSIONS Mass screening and treatment for latent tuberculosis had no significant effect on tuberculosis control in South African gold mines , despite the successful use of isoniazid in preventing tuberculosis during treatment . ( Funded by the Consortium to Respond Effectively to the AIDS TB Epidemic and others ; Thibela TB Current Controlled Trials number , IS RCT N63327174 . ) BACKGROUND A 9-month course of isoniazid monotherapy is currently recommended for the treatment of latent tuberculosis infection ( LTBI ) and has been shown to be effective in both children and adults . Reduced compliance with this regimen has forced physicians to explore shorter regimens . The aim of this study was to compare 3- and 4-month combination regimens of isoniazid plus rifampin with a 9-month regimen of isoniazid monotherapy for the treatment of LTBI in children . METHODS This prospect i ve , r and omized , controlled study was conducted over an 11-year period ( 1995 - 2005 ) . In period 1 ( 1995 - 1998 ) , 232 patients received isoniazid therapy for 9 months ( group A ) , and 238 patients received isoniazid and rifampin for 4 months ( group B ) . In period 2 ( 1999 - 2002 ) , 236 patients were treated with isoniazid and rifampin for 4 months ( group C ) , and 220 patients received the same regimen for 3 months ( group D ) . All patients were observed for > or = 3 years . RESULTS Overall compliance with treatment was good , but patients who received isoniazid monotherapy were less compliant than were those who received short-course combination therapy ( P=.011 , for group A vs. group B ; P=.510 , for group C vs. group D ) . No patient in any group developed clinical disease during the follow-up period . New radiographic findings suggestive of possible active disease were more common in patients who received isoniazid monotherapy ( 24 % ) than in those treated with shorter regimens ( 11.8 % , 13.6 % , and 11 % for groups B , C , and D , respectively ; P=.001 for group A vs. group B ; P=.418 for group C vs. group D ) . Serious drug-related adverse effects were not detected . CONCLUSIONS Short-course treatment with isoniazid and rifampin for 3 - 4 months is safe and seems to be superior to a 9-month course of isoniazid monotherapy INTRODUCTION The aim of this study was to compare the adherence to , and side effects of a 3-month short-course treatment for latent tuberculosis infection as compared to the st and ard 6-month course . METHODS Prospect i ve , comparative , r and omized , open trial including patients with a positive tuberculin skin test and appropriate criteria for treatment in accordance with the CDC guidelines , and excluding patients with HIV infection . Group I ( 6H ) was assigned to isoniazid 300 mg per day for 6 months and Group II ( 3HR ) was assigned to isoniazid 300 mg per day plus rifampin 600 mg per day for 3 months . The patients were followed up for five years . RESULTS A total of 105 patients were included , among which 9 refused treatment ; 45 patients were placed in Group I and 51 patients in Group II . Both groups were comparable at baseline . Hepatotoxicity was 44 % in Group 6H and 29 % in Group 3HR ( P = 0.07 ) . Hepatotoxicity was severe in 6.7 % of Group 6H and 5.8 % of Group 3HR , requiring treatment interruption in 4.4 % and 1.9 % , respectively ( P = NS ) . Among the total , 75.6 % of patients in group 6H , and 90.2 % in group 3HR completed the study treatment ( P = 0.05 ) . Tuberculous disease was detected in only one patient in the 6H group , occurring in the second month of treatment . CONCLUSION In the treatment of latent tuberculosis infection , a 3-month course of isoniazid plus rifampin result ed in better adherence and a lower percentage of discontinued treatments than a 6-month isoniazid course . Tolerance was similar in the two regimens SETTING Nine public health care centres in four Spanish cities . OBJECTIVE To evaluate the efficacy and safety of 2 months of rifampicin ( R ) plus pyrazinamide ( Z ) therapy ( 2RZ ) compared with a 6-month course of isoniazid therapy ( 6H ) for treating latent tuberculosis infection ( LTBI ) . DESIGN Multicentered , r and omised , comparative and prospect i ve trial conducted in HIV-seronegative contacts of infectious pulmonary TB cases . RESULTS Of 352 individuals , 199 received 6H and 153 2RZ ; 73 % of contacts receiving 6H and 71 % receiving 2RZ completed treatment ( P = 0.73 ) . Treatment interruption due to hepatotoxicity ( ALT/AST > 5 times upper limit of normal ) was observed in 10 % of contacts in the 2RZ group and in 2.5 % of the 6H group ( P = 0.007 ) . This higher than expected rate of hepatotoxicity in the 2RZ arm led to premature termination of the study . Severe or fatal liver injury was not detected . Liver function tests normalised after discontinuation of treatment . We conclude that the use of RZ should only be considered when other regimens are unsuitable and intensive monitoring of liver function is feasible There is little published information regarding treatment completion , safety , and efficacy of rifampin administered daily for 4 months-a recommended alternative to 9 months of isoniazid for therapy of latent tuberculosis infection . In an open-label r and om
Output:
| All regimens of interest except INH-9 showed significant benefits in preventing active TB compared to placebo .
Comparisons between active regimens did not reveal significant differences .
While definitions of regimen completion varied across studies , regimens of 3–4 months were associated with a greater likelihood of adequate completion .
Conclusions Most of the active regimens showed an ability to reduce the risk of active TB relative to no treatment , however important differences between active regimens were not found .
Shorter rifamycin-based regimens may offer comparable benefits to longer INH regimens .
Regimens of 3–4 months duration are more likely to be completed than longer regimens |
MS213572 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background The workplace is an ideal setting for health promotion . Helping employees to be more physically active can not only improve their physical and mental health , but can also have economic benefits such as reduced sickness absence . The current paper describes the development of a three month theory-based intervention that aims to increase levels of moderate intensity physical activity amongst employees in sedentary occupations . Methods The intervention was developed using an intervention mapping protocol . The intervention was also informed by previous literature , qualitative focus groups , an expert steering group , and feedback from key contacts within a range of organisations . Results The intervention was design ed to target awareness ( e.g. provision of information ) , motivation ( e.g. goal setting , social support ) and environment ( e.g. management support ) and to address behavioural ( e.g. increasing moderate physical activity in work ) and interpersonal outcomes ( e.g. encourage colleagues to be more physically active ) . The intervention can be implemented by local facilitators without the requirement for a large investment of re sources . A facilitator manual was developed which listed step by step instructions on how to implement each component along with a suggested timetable . Conclusion Although time consuming , intervention mapping was found to be a useful tool for developing a theory based intervention . The length of this process has implication s for the way in which funding bodies allow for the development of interventions as part of their funding policy . The intervention will be evaluated in a cluster r and omised trial involving 1350 employees from 5 different organisations , results available September 2009 1 The AAPD encourages oral health care providers and caregivers to implement 17 simple preventive practice s that can decrease a childs risks of developing this devastating disease . 18 19 20 21 Methods This policy revision is based on a review of the current pediatric dental , medical , and public health literature related to ECC , including 22 the proceedings of the 2005 Symposium on the Prevention of Oral Disease in Children and Adolescents , Chicago , Illinois1997 Conference on Early Childhood Caries , Bethesda , Md.1 A MEDLINE search was conducted using the terms early childhood caries , nursing caries , and baby bottle caries. 25 The literature includes studies that used sound scientific methodology , were reported in refereed journals , and are accepted by the dental profession as state of the art in caries causes and prevention . The literature on the consequences of ECC is based on both prospect i ve and retrospective clinical studies that followed accepted clinical protocol s. Preventive recommendations were based primarily upon review of published studies and proceedings . In cases where the data did not appear sufficient or were inconclusive , recommendations were based upon expert and consensus opinion . 23 Scottish children have one of the highest levels of caries experience in Europe . Only 33 % of 5-year-old children in Dundee who developed caries in their first permanent molars by 7 brushed their teeth twice a day . High-caries-risk children should benefit if they brush more often with fluori date d toothpaste . The aim of this clinical trial was to determine the reduction in 2-year caries increment that can be achieved by daily supervised toothbrushing on school-days with a toothpaste containing 1,000 ppm fluoride ( as sodium monofluorophosphate ) and 0.13 % calcium glycerophosphate , combined with recommended daily home use , compared to a control group involving no intervention other than 6-monthly clinical examinations . Five hundred and thirty-four children , mean age 5.3 , in schools in deprived areas of Tayside were recruited . Each school had two parallel classes , one r and omly selected to be the brushing class and the other , the control . Local mothers were trained as toothbrushing supervisors . Children brushed on school-days and received home supplies . A single examiner undertook 6-monthly examinations recording plaque , caries ( D1 level ) , and used FOTI to supplement the visual caries examination . For children in the brushing classes , the 2-year mean caries increment on first permanent molars was 0.81 at D1 and 0.21 at D3 compared to 1.19 and 0.48 for children in the control classes ( significant reductions of 32 % at D1 and 56 % at D3 ) . In conclusion , high-caries-risk children have been shown to have significantly less caries after participating in a supervised toothbrushing programme with a fluori date d toothpaste The purpose of this study was to describe oral hygiene factors in infants and toddlers living in Sweden with special reference to caries prevalence at 2 and 3 yr of age and to immigrant status . The study was design ed as a prospect i ve , longitudinal study starting with 671 children aged 1 yr . At 3 yr , all the children were invited to a further examination . A total of 298 children , r and omly selected from the original group , were also examined at 2 yr . The accompanying parent was interviewed about the child 's oral health habits . Children who were free of caries at 3 yr had had their teeth brushed more frequently at 1 and 2 yr of age , had used fluoride (F)-toothpaste more often at 2 yr of age , and had a lower prevalence of visible plaque at 1 and 2 yr of age than children with caries . Immigrant children had had their teeth brushed less frequently , had used less F-toothpaste , and had a higher prevalence of visible plaque at 1 yr of age than nonimmigrant children . Early establishment of good oral hygiene habits and regular use of F-toothpaste seem to be important for achieving good oral health in pre-schoolchildren
Output:
| Results The comprehensive needs assessment highlighted key barriers to PSB , such as knowledge , skills , self-efficacy , routine setting and behaviour regulation and underlined the importance of individual , social and structural influences .
Parenting skills ( routine setting and the ability to manage the behaviour of a reluctant child ) were emphasised as critical to the success of PSB .
IM , although a time-consuming process , allowed us to capture this complexity and allowed us to develop two community-based intervention pathways covering both universal and targeted approaches , which can be integrated into current provision . |
MS213573 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement BACKGROUND Quality improvement ( QI ) programs for depressed primary care patients can improve health outcomes for 6 to 28 months ; effects for longer than 28 months are unknown . OBJECTIVE To assess how QI for depression affects health outcomes , quality of care , and health outcome disparities at 57-month follow-up . DESIGN A group-level r and omized controlled trial . SETTING Forty-six primary care practice s in 6 managed care organizations . PATIENTS Of 1356 primary care patients who screened positive for depression and enrolled in the trial , 991 ( 73 % , including 451 Latinos and African Americans ) completed 57-month telephone follow-up . INTERVENTIONS Clinics were r and omly assigned to usual care or to 1 of 2 QI programs supporting QI teams , provider training , nurse assessment , and patient education , plus re sources to support medication management ( QI-meds ) or psychotherapy ( QI-therapy ) for 6 to 12 months . MAIN OUTCOME MEASURES Probable depressive disorder in the previous 6 months , mental health-related quality of life in the previous 30 days , primary care or mental health specialty visits , counseling or antidepressant medications in the previous 6 months , and unmet need , defined as depressed but not receiving appropriate care . RESULTS Combined QI-meds and QI-therapy , relative to usual care , reduced the percentage of participants with probable disorder at 5 years by 6.6 percentage points ( P = .04 ) . QI-therapy improved health outcomes and reduced unmet need for appropriate care among Latinos and African Americans combined but provided few long-term benefits among whites , reducing outcome disparities related to usual care ( P = .04 for QI-ethnicity interaction for probable depressive disorder ) . CONCLUSIONS Programs for QI for depressed primary care patients implemented by managed care practice s can improve health outcomes 5 years after implementation and reduce health outcome disparities by markedly improving health outcomes and unmet need for appropriate care among Latinos and African Americans relative to whites ; thus , equity was improved in the long run It is difficult to evaluate the promise of primary care quality -improvement interventions for depression because published studies have evaluated diverse interventions by using different research design s in dissimilar population s. Preplanned meta- analysis provides an alternative to derive more precise and generalizable estimates of intervention effects ; however , this approach requires the resolution of analytic challenges result ing from design differences that threaten internal and external validity . This paper describes the four-project Quality Improvement for Depression ( QID ) collaboration specifically design ed for preplanned meta- analysis of intervention effects on outcomes . This paper summarizes the interventions the four projects tested , characterizes commonalities and heterogeneity in the research design s used to evaluate these interventions , and discusses the implication s of this heterogeneity for preplanned meta- analysis Abstract Objectives : To evaluate the long term effect of ongoing intervention to improve treatment of depression in primary care . Design : R and omised controlled trial . Setting : Twelve primary care practice s across the United States . Participants : 211 adults beginning a new treatment episode for major depression ; 94 % of patients assigned to ongoing intervention participated . Intervention : Practice s assigned to ongoing intervention encouraged participating patients to engage in active treatment , using practice nurses to provide care management over 24 months . Main outcome measures : Patients ' report of remission and functioning . Results : Ongoing intervention significantly improved both symptoms and functioning at 24 months , increasing remission by 33 percentage points ( 95 % confidence interval 7 % to 46 % ) , improving emotional functioning by 24 points ( 11 to 38 ) and physical functioning by 17 points ( 6 to 28 ) . By 24 months , 74 % of patients in enhanced care reported remission , with emotional functioning exceeding 90 % of population norms and physical functioning approaching 75 % of population norms . Conclusions : Ongoing intervention increased remission rates and improved indicators of emotional and physical functioning . Studies are needed to compare the cost effectiveness of ongoing depression management with other chronic disease treatment routinely undertaken by primary care BACKGROUND This article addresses whether dissemination of short-term quality improvement ( QI ) interventions for depression to primary care practice s improves patients ' clinical outcomes and health-related quality of life ( HRQOL ) over 2 years , relative to usual care ( UC ) . METHODS The sample included 1299 patients with current depressive symptoms and 12-month , lifetime , or no depressive disorder from 46 primary care practice s in 6 managed care organizations . Clinics were r and omized to UC or 1 of 2 QI programs that included training local experts and nurse specialists to provide clinician and patient education , assessment , and treatment planning , plus either nurse care managers for medication follow-up ( QI-meds ) or access to trained psychotherapists ( QI-therapy ) . Outcomes were assessed every 6 months for 2 years . RESULTS For most outcomes , differences between intervention and UC patients were not sustained for the full 2 years . However , QI-therapy reduced overall poor outcomes compared with UC by about 8 percentage points throughout 2 years , and by 10 percentage points compared with QI-meds at 24 months . Both interventions improved patients ' clinical and role outcomes , relative to UC , over 12 months ( eg , a 10 - 11 and 6 - 7 percentage point difference in probable depression at 6 and 12 months , respectively ) . CONCLUSIONS While most outcome improvements were not sustained over the full 2 study years , findings suggest that flexible dissemination of short-term , QI programs in managed primary care can improve patient outcomes well after program termination . Models that support integrated psychotherapy and medication-based treatment strategies in primary care have the potential for relatively long-term patient benefits BACKGROUND The diagnosis and treatment of depression constitutes a significant component of a general practitioner 's workload . A pilot study has suggested that the practice nurse may have an important contribution to make in the care of patients with depression . AIM To evaluate an extended role for practice nurses in improving the outcome of depression through two specially- design ed interviews running in parallel . METHOD Two naturalistic , r and om allocation studies took place concurrently over four months . Study 1 evaluated the effectiveness of st and ardized psychiatric assessment by a practice nurse and feedback of information to the general practitioner ( GP ) . Study 2 evaluated the above assessment and feedback combined with nurse-assisted follow-up care . Twenty general practice s participating in the Medical Research Council General Practice Research Framework took part in the study . Subjects included general practice attenders identified as depressed by their GP . The main outcome measures were a change in Beck Depression Inventory ( BDI ) scores and in the proportion of patients fulfilling DSM-III criteria for major depression . RESULTS A total of 577 patients were recruited ; 516 [ 89 % ( 95 % CI = 86 - 92 % ) ] were rated as depressed on the BDI and 474 [ 82 % ( 95 % CI = 79 - 85 % ) ] met criteria for DSM-III major depression . Altogether , 524 ( 91 % ) patients completed follow-up at four months . All groups of patients showed improvement , but no difference in the rate of improvement was shown for the nurse intervention groups . BDI mean scores fell from 18.54 ( 95 % CI = 17.53 - 20.06 ) to 11.53 ( 95 % CI = 10.02 - 13.04 ) in Study 1 , and from 21.01 ( 95 % = CI 20.26 - 21.86 ) to 10.62 ( 95 % CI = 9.73 - 11.51 ) in Study 2 . The proportion of patients fulfilling criteria for DSM-III major depression in Study 1 fell from 80 % ( 95 % CI = 73 - 87 % ) to 30 % ( 95 % CI = 22 - 38 % ) , and in Study 2 from 80 % ( 95 % CI = 76 - 84 % ) to 27 % ( 95 % CI = 23 - 31 % ) . Prescription rates of antidepressant medication were higher than expected , ranging between 63 % and 76 % in the two studies . CONCLUSION There was an increase in the rate of antidepressant prescription , but no additional benefit could be adduced for patients who received a nurse intervention BACKGROUND Despite improvements in the accuracy of diagnosing depression and use of medications with fewer side effects , many patients treated with antidepressant medications by primary care physicians have persistent symptoms . METHODS A group of 228 patients recognized as depressed by their primary care physicians and given antidepressant medication who had either 4 or more persistent major depressive symptoms or a score of 1.5 or more on the Hopkins Symptom Checklist depression items at 6 to 8 weeks were r and omized to a collaborative care intervention ( n = 114 ) or usual care ( n = 114 ) by the primary care physician . Patients in the intervention group received enhanced education and increased frequency of visits by a psychiatrist working with the primary care physician to improve pharmacologic treatment . Follow-up assessment s were completed at 1 , 3 , and 6 months by a telephone survey team blinded to r and omization status . RESULTS Those in the intervention group had significantly greater adherence to adequate dosage of medication for 90 days or more and were more likely to rate the quality of care they received for depression as good to excellent compared with usual care controls . Intervention patients showed a significantly greater decrease compared with usual care controls in severity of depressive symptoms over time and were more likely to have fully recovered at 3 and 6 months . CONCLUSIONS A multifaceted program targeted to patients whose depressive symptoms persisted 6 to 8 weeks after initiation of antidepressant medication by their primary care physician was found to significantly improve adherence to antidepressants , satisfaction with care , and depressive outcomes compared with usual care Objectives : Screening is advocated to improve the recognition of patients with major depression in primary care . Furthermore , disease management programmes are advocated to improve the quality of care and outcome for these patients . But is screening and the subsequent implementation of a disease management programme more effective than usual care ? Methods : Review of the literature on the effects of disease management programmes that include screening for major depression in general practice . Results : Six r and omised controlled trials were identified in which the effectiveness of disease management programmes were studied in patients with major depression in primary care and compared with usual care . The majority of these , and especially the largest , showed positive effects on the recognition , diagnosis , treatment and outcome of patients . Population s in the US seem to benefit most . Conclusion : The results of disease management programmes for depression in primary care that include screening are positive and are more effective than usual care . Therefore , if preceded by screening , attention to the whole process of care for patients with major depression instead of paying attention to isolated elements of the process is justified Most depressed patients are seen and treated exclusively by primary care clinicians . However , primary care patients with depression are often not adequately treated . The aims of this pilot study were to measure the impact of a telephone disease management program on patient outcome and clinician adherence to practice guidelines , measure the relationship of clinician adherence to patient outcome , and explore the measurement of patient adherence to clinician recommendations and its impact on patient outcomes . Thirty-five primary care practice s in the University of Pennsylvania Health System were r and omized to telephone disease management ( TDM ) or " usual care " ( UC ) . All patients received a baseline and a 16-week follow-up clinical evaluation performed over the telephone . Those from TDM practice s also received follow-up contact at least every 3 weeks , with formal evaluations at weeks 6 and 12 . These interval contacts were design ed to facilitate patient and clinician adherence to a treatment algorithm based on the Agency for Health Research and Quality ( AHRQ ) practice guidelines . Depressive symptoms evaluated with the Community Epidemiologic Survey of Depression ( CES-D ) scale as well as guideline adherence were the primary outcome measures . Sixty-one patients were enrolled in this pilot project . The overall effect for CES-D scores over time was significant , ( P < .001 ) , indicating that those participating in the trial ( both TDM and UC groups ) showed significant improvement . The interaction between intervention condition and time was also significant ( P < .05 ) , indicating that
Output:
| ConclusionS ystem level interventions implemented in the USA with patients willing to take anti-depressant medication leads to a modest increase in recovery from depression . |
MS213574 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND AND STUDY AIMS Hepatocellular carcinoma ( HCC ) is a major burden on health-care systems worldwide . Although radiofrequency ablation ( RFA ) is currently considered the best technique for coagulative necrosis , the superiority of concomitant use of RFA and percutaneous ethanol injection ( PEI ) needs to be determined . The study was design ed to compare efficacy , safety and rate of survival of patients with HCC assigned to receive combined PEI-RFA versus RFA alone and versus PEI alone . PATIENTS AND METHODS This 3-year study enrolled 90 cirrhotic patients with HCC ( Child 's class A or B , but not class C ) . They were r and omly assigned for either PEI-RFA ( group I ) , RFA alone ( group II ) or PEI alone ( group III ) . The primary end point was ablation of the tumour . The secondary end point was rate of survival and recurrence . RESULTS After the first session , complete ablation was significantly higher in the combination group ( 87.9 % ) compared with the RFA group ( 54.54 % ) . After the second session , complete ablation was achieved in 97.0 % of the combination group and in 84.8 % of the RFA group . Regarding the PEI group , 75 % had complete ablation , whereas 25 % had partial ablation after multiple sessions . The survival rate , 1.5 years later , was significantly higher in group I ( 86.7 % ) compared with group III ( 63.3 % ) . The overall incidence of serious adverse events was nil . CONCLUSION Combined treatment is superior to RFA alone and to PEI alone , in safety and efficacy in patients with HCC Aims : The aim of this study was to compare the outcomes of radiofrequency thermal ablation ( RFTA ) , percutaneous ethanol injection ( PEI ) , and percutaneous acetic acid injection ( PAI ) in the treatment of hepatocellular carcinoma ( HCC ) . Patients and methods : A total of 187 patients with HCCs of 3 cm or less were r and omly assigned to RFTA ( n = 62 ) , PEI ( n = 62 ) , or PAI ( n = 63 ) . Tumour recurrence and survival rates were assessed . Results : One , two , and three year local recurrence rates were 10 % , 14 % , and 14 % in the RFTA group , 16 % , 34 % , and 34 % in the PEI group , and 14 % , 31 % , and 31 % in the PAI group ( RFTA v PEI , p = 0.012 ; RFTA v PAI , p = 0.017 ) . One , two , and three year survival rates were 93 % , 81 % , and 74 % in the RFTA group , 88 % , 66 % , and 51 % in the PEI group , and 90 % , 67 % , and 53 % in the PAI group ( RFTA v PEI , p = 0.031 ; RFTA v PAI , p = 0.038 ) . One , two , and three year cancer free survival rates were 74 % , 60 % , and 43 % in the RFTA group , 70 % , 41 % , and 21 % in the PEI group , and 71 % , 43 % , and 23 % in the PAI group ( RFTA v PEI , p = 0.038 ; RFTA v PAI , p = 0.041 ) . Tumour size , tumour differentiation , and treatment methods ( RFTA v PEI and PAI ) were significant factors for local recurrence , overall survival , and cancer free survival . Major complications occurred in 4.8 % of patients ( two with haemothorax , one gastric perforation ) in the RFTA group and in none in two other groups ( RFTA v PEI and PAI , p = 0.035 ) . Conclusions : RFTA was superior to PEI and PAI with respect to local recurrence , overall survival , and cancer free survival rates , but RFTA also caused more major complications To assess whether ultrasound‐guided percutaneous acetic acid injection is superior to percutaneous ethanol injection in the treatment of small hepatocellular carcinoma ( HCC ) , 60 patients with one to four HCCs smaller than 3 cm were entered onto a r and omized controlled trial . Thirty‐one and 29 patients , respectively , were treated by percutaneous acetic acid injection using 50 % acetic acid or by percutaneous ethanol injection using absolute ethanol . There were no significant differences in age , sex ratio , Child‐Pugh class , size of tumors , or number of tumors between the two groups . When there was no evidence of viable HCC from biopsy , plain and helical dynamic computed tomography , or angiography , the treatment was considered successful and was discontinued . All original tumors were treated successfully by either therapy . However , 8 % of 38 tumors treated with percutaneous acetic acid injection and 37 % of 35 tumors treated with percutaneous ethanol injection developed a local recurrence ( P < .001 ) during the follow‐up periods of 29 ± 8 months and 23 ± 10 months , respectively . The 1‐ and 2‐year survival rates were 100 % and 92 % in percutaneous acetic acid injection and 83 % and 63 % in percutaneous ethanol injection ( P = .0017 ) . A multivariate analysis of prognostic factors revealed that treatment was an independent predictor of survival . The risk ratio of percutaneous acetic acid injection versus percutaneous ethanol injection was 0.120 ( range , 0.027‐0.528;P = .0050 ) . In conclusion , percutaneous acetic acid injection is superior to percutaneous ethanol injection in the treatment of small HCC BACKGROUND & AIMS The aim of this study was to compare the clinical outcome of percutaneous radiofrequency ( RF ) ablation , conventional percutaneous ethanol injection ( PEI ) , and higher-dose PEI in treating hepatocellular carcinoma ( HCC ) 4 cm or less . METHODS A total of 157 patients with 186 HCCs 4 cm or less were r and omly assigned to 3 groups ( 52 patients in the conventional PEI group , 53 in the higher-dose PEI group , and 52 in the RF group ) . Clinical outcomes in terms of complete tumor necrosis , overall survival , local tumor progression , additional new tumors , and cancer-free survival were compared across 3 groups . RESULTS The rate of complete tumor necrosis was 88 % in the conventional PEI group , 92 % in the higher-dose PEI group , and 96 % in the RF group . Significantly fewer sessions were required to achieve complete tumor necrosis in the RF group than in the other 2 groups ( P < .01 ) . The local tumor progression rate was lowest in the RF group ( vs the conventional PEI group , P = .012 ; vs the higher-dose PEI group , P = .037 ) . The overall survival rate was highest in the RF group ( vs the conventional PEI group , P = .014 ; vs the higher-dose PEI group , P = .023 ) . The cancer-free survival rate was highest in the RF group ( vs the conventional PEI group , P = .019 ; vs the higher-dose PEI group , P = .024 ) . Multivariate analysis determined that tumor size , tumor differentiation , and the method of treatment ( RF vs both methods of PEI ) were significant factors in relation to local tumor progression , overall survival , and cancer-free survival . CONCLUSIONS The results show that RF ablation yielded better clinical outcomes than conventional and higher-dose PEI in treating HCC 4 cm or less AIM To compare 5-year survival of patients with a single hepatocellular carcinoma≤3 cm r and omly assigned to receive percutaneous ethanol injection or radiofrequency ablation . PATIENTS AND METHODS A total of 285 patients ( 192 males , mean age 70 years ) , with a single hepatocellular carcinoma ( mean diameter 2.2 cm ) were r and omly assigned to receive percutaneous ethanol injection ( n=143 ) or radiofrequency ablation ( n=142 ) . The primary endpoint of the study was 5-year survival . RESULTS Overall 143 patients underwent percutaneous ethanol injection and 128 radiofrequency ablation . In consideration of segmental location , in fact , 14 patients with 14 hepatocellular carcinomas could not be treated with established radiofrequency and were treated with percutaneous ethanol injection ; these patients were not included in the survival evaluation . In the percutaneous ethanol injection and in the radiofrequency ablation groups , 3- and 5-year survival rates of 74 % and 68 % , and 78 % and 68 % , and 79 % and 70 % [ corrected ] respectively , were observed ( p = n.s ) . In the percutaneous ethanol injection group , 3- and 5-year local recurrence rates were 9.4 % and 12.8 % respectively ; in the radiofrequency group , the 3 and 5 years local recurrence rates were 7.8 % and 11.7 % , respectively ( p = n.s . ) . The overall costs of percutaneous ethanol injection and radiofrequency ablation were 1359 Euros and 171.000 Euros , respectively ( p<0.0001 ) CONCLUSION Percutaneous ethanol injection and radiofrequency ablation conferred similar 5-year survival . Feasibility is not the same for both procedures . Percutaneous ethanol injection is much cheaper than radiofrequency ablation and should be considered whether in poor and rich countries BACKGROUND Ninety percent of patients with hepatocellular carcinoma ( HCC ) have cirrhosis . Bleeding esophageal varices ( BEV ) is a frequent complication of cirrhosis . Detection of HCC in cirrhotic patients with BEV has not been studied . METHODS Two hundred eleven unselected patients with cirrhosis and BEV were r and omized to endoscopic sclerotherapy ( n = 106 ) or emergency portacaval shunt ( n = 105 ) . Diagnostic workup and treatment were initiated within 8 hours . Ninety-six percent had > 10 years of follow-up . HCC screening involved serum α-fetoprotein ( AFP ) every 3 months , ultrasonography every 6 months , and selective computed tomography ( CT ) . RESULTS HCC occurred in 15 patients , all incurable , a mean of 2.94 years after entry . They died a mean 1.33 years after discovery . Serial AFP and ultrasound examinations were unrevealing over a mean of 2.3 years . The mean model of end-stage liver disease score was 12.7 at entry and 17.4 at HCC diagnosis . CONCLUSIONS Long-term screening by AFP and ultrasound plus selective CT failed to detect HCC at a curable stage . The detection of HCC in cirrhotic patients with BEV remains a serious , unsolved problem . The use of CT for routine screening warrants consideration despite increased costs Objective . To compare percutaneous ethanol injection ( PEI ) , the st and ard approach which has been used for many years to treat early non-surgical hepatocellular carcinoma ( HCC ) in cirrhotic patients , and radiofrequency ablation ( RFA ) , which has become an interesting alternative . Material and methods . A r and omized trial was carried out on 139 cirrhotic patients in Child-Pugh classes A/B with 1–3 nodes of HCC ( diameter 15–30 mm ) , for a total of 177 lesions . Patients were r and omized to receive RFA ( n=70 ) or PEI ( n=69 ) . The primary end-point was complete response ( CR ) 1 year after the percutaneous ablation of all HCC nodes identified at baseline . Secondary end-points were : early ( 30–50 days ) CR , complications , survival and costs . Results . In an intention-to-treat analysis , 1-year CR was achieved in 46/70 ( 65.7 % ) and in 25/69 ( 36.2 % ) patients treated by RFA and PEI , respectively ( p=0.0005 ) . For lesions > 20 mm in diameter , there was a larger CR rate in the RFA group ( 68.1 % versus 26.3 % ) . An early CR was obtained in 67/70 ( 95.7 % ) patients treated by RFA compared with 42/64 ( 65.6 % ) patients treated by PEI ( p=0.0001 ) . Complications occurred in 10 and 12 patients treated by RFA and PEI , respectively . The overall survival rate was not significantly different in the RFA versus PEI arm ( adjusted hazard ratio=0.88 , 95 % CI : 0.50–1.53 ) . There was an incremental health-care cost of 8286 € for each additional patient successfully treated by RFA . Conclusions . The 1-year CR rate after percutaneous treatment of early HCC was significantly better with RFA than with PEI but did not provide a clear survival advantage in cirrhotic patients PURPOSE To compare the effectiveness of radio-frequency ( RF ) thermal ablation with that of percutaneous ethanol injection ( PEI ) for the treatment of small hepatocellular carcinoma ( HCC
Output:
| RFA had a lower risk of local recurrence ( HR = 0.38 , 95 % CI : 0.15 - 0.96 , P = 0.040 ) , but no difference is seen for distant intrahepatic recurrence .
RFA had higher rates of complete tumor necrosis , but RFA also caused more major complications and was more costly than PEI .
RFA appears superior to PEI with respect to local tumor control and 3-year survival for small HCCs < 3 cm .
RFA was more feasible in patients with HCCs > 2 cm or Child-Pugh A liver function |
MS213575 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: In 30 physically and mentally healthy volunteers , 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5 - 2H-1,4-benzodiazepin-2-one ( temazepam , K 3917 ) was tested for its sleep inducing action , the subjective quality of sleep and any post-medication effects . Temazepam was orally administered at doses of 15 , 20 or 30 mg in hard gelatin capsules or 20 mg in soft gelatin capsules . Nitrazepam ( 5 mg ) and amylobarbitone sodium ( 100 mg ) were used for comparison as well as a placebo . Temazepam showed very much the same effects as they are known from conventional 1,4-benzodiazepines except for its lack of impairment in early morning behavior following night time medication In this paper the psychometric properties of the multidimensional fatigue inventory ( MFI-20 ) are established further in cancer patients . The MFI is a 20-item self-report instrument design ed to measure fatigue . It covers the following dimensions : general fatigue , physical fatigue , reduced activity , reduced motivation and mental fatigue . The instrument was used in a Dutch and Scottish sample of cancer patients receiving radiotherapy . The dimensional structure was assessed using confirmatory factor analyses ( Lisrel 's unweighted least-squares method ) . The hypothesised five-factor model appeared to fit the data in both sample s ( adjusted goodness of fit ; AGFI : 0.97 and 0.98 ) . Internal consistency of the separate scales was good in both the Dutch and Scottish sample s with Cronbach 's alpha coefficients ranging from 0.79 to 0.93 . Construct validity was assessed by correlating the MFI-20 to activities of daily living , anxiety and depression . Significant relations were assumed . Convergent validity was investigated by correlating the MFI scales with a visual analogue scale measuring fatigue and with a fatigue-scale derived from the Rotterdam Symptom Checklist . Results support the validity of the MFI-20 . The highly similar results in the Dutch and Scottish sample suggest that the portrayal of fatigue using the MFI-20 is quite robust In the absence of a golden st and ard for the diagnosis of narcolepsy , the clinical spectrum of disorder remains controversial . The aims of this study were ( 1 ) to determine frequency and characteristics of sleep-wake symptoms in patients with narcolepsy with cataplexy , ( 2 ) to compare clinical characteristics with results of ancillary tests , and ( 3 ) to identify factors that discriminate narcolepsy from other conditions with excessive daytime sleepiness ( EDS ) . We prospect ively studied 57 narcoleptics with cataplexy , 56 patients with non-narcoleptic hypersomnia ( H ) , and 40 normal controls ( No ) . Based on suggested and published criteria , we differentiated between narcoleptics with definite cataplexy ( N ) and narcoleptics without definite cataplexy ( possible cataplexy , NpC ) . Assessment consisted of question naires [ all patients and controls , including the Ullanlinna Narcolepsy Score ( UNS ) ] , polysomnography ( all patients ) , multiple sleep latency test ( MSLT ) and human leukocyte antigen typing ( in most narcoleptics ) . A new narcolepsy score based on five questions was developed . Data were compared with those of 12 hypocretin-deficient narcoleptics ( N-hd ) . There were significant differences between N and NpC ( including mean sleep latency on MSLT ) , but none between N and N-hd . A score of sleep propensity during active situations ( SPAS ) and the frequency of sleep paralysis/hallucinations at sleep onset , dreams of flying , and history of sleep shouting discriminated N from H and No ( P < 0.001 ) . Cataplexy-like symptoms in H ( 18 % ) and No ( 8 % ) could be discriminated from ' true ' cataplexy in N on the basis of topography of motor effects , triggering emotions and triggering situations ( P < 0.001 ) . Our narcolepsy score had a similar sensitivity ( 96 % versus 98 % ) but a higher specificity ( 98 % versus 56 % ) than the UNS . Analysis of co-occurring symptoms in narcolepsy revealed two symptom complexes : EDS , cataplexy , automatic behaviors ; and sleep paralysis , hallucinations , parasomnias . Low/undetectable cerebrospinal fluid hypocretin-1 levels and a history of definite cataplexy identify similar subgroups of narcoleptics . Specific questions on severity of EDS ( SPAS score ) and characteristics of cataplexy allow the recognition of subgroups of narcoleptics and their differentiation from non-narcoleptic EDS patients , including those reporting cataplexy-like episodes . The existence of co-occurring symptoms supports the hypothesis of a distinct pathophysiology of single narcoleptic symptoms Fichtenberg NL , Putnam SH , Mann NR , Zafonte RD , Millard AE : Insomnia screening in postacute traumatic brain injury : utility and validity of the Pittsburgh Sleep Quality Index . Am J Phys Med Rehabil 2001;80:339–345 . Objective To assess insomnia in a rehabilitation population , the authors examined the utility and validity of the Pittsburgh Sleep Quality Index ( PSQI ) . The assessment of insomnia is relevant to the treatment of traumatic brain injury at the postacute level and routine screening for insomnia may be enhanced by the availability of a st and ardized , conveniently used , self-report sleep question naire . Design The authors prospect ively studied 91 consecutive patients with traumatic brain injury who were admitted to an outpatient neurorehabilitation program . Besides administering the PSQI , Beck Depression Inventory , Epworth Sleepiness Scale , and Multidimensional Pain Inventory , sleep diary and interview data were obtained and used to divide subjects into insomnia and noninsomnia groups according to the criteria established by the Diagnostic and Statistical Manual of Mental Disorders , ed 4 . Results Sensitivity and specificity rates to the clinical diagnosis of insomnia were 93 % and 100 % , respectively , for a PSQI Global Score of > 8 , and 83 % and 100 % for a diagnosis of insomnia based exclusively on PSQI-derived sleep variable data . Sleep diary data provided concurrent validity for PSQI estimates of sleep-onset latency , sleep duration , and sleep efficiency . The Beck Depression Inventory , Epworth Sleepiness Scale , and Multidimensional Pain Inventory established concurrent validity for individual PSQI items pertaining to mood , hypersomnia , and pain disturbance . Conclusion The PSQI was demonstrated to be a valid and useful screening tool for assessing insomnia among postacute patients with traumatic brain injury Dysfunctional beliefs and attitudes about sleep are presumed to play an important mediating role in perpetuating insomnia . The present study evaluated the impact of cognitive-behavioral and pharmacological treatments for insomnia on sleep-related beliefs and attitudes and the relationship between those changes and sleep improvements . The participants were older adults with chronic and primary insomnia . They received cognitive-behavior therapy ( CBT ) , pharmacotherapy ( PCT ) , combined CBT+PCT ( COMB ) , or a medication placebo ( PLA ) . In addition to daily sleep diaries and sleep laboratory measures , the participants completed the dysfunctional beliefs and attitudes about sleep scale ( DBAS ) at baseline and posttreatment , and at 3- , 12- and 24-month follow-up assessment s. The results showed that CBT and COMB treatments produced greater improvements of beliefs and attitudes about sleep at posttreatment than PCT and PLA . Reductions of DBAS scores were significantly correlated with improvements of sleep efficiency as measured by daily sleep diaries and by polysomnography . In addition , more adaptive beliefs and attitudes about sleep at posttreatment were associated with better maintenance of sleep improvements at follow-ups . These findings highlight the importance of targeting sleep-related beliefs and attitudes in the treatment of insomnia BACKGROUND This study aim ed to investigate the effects of methylpheni date and sertraline compared with placebo on various neuropsychiatric sequelae associated with traumatic brain injury ( TBI ) . METHODS This was a 4 week , double-blind , parallel-group trial . Thirty patients with mild to moderate degrees of TBI were r and omly allocated to one of three treatment groups ( n = 10 in each group ) with matching age , gender and education , i.e. methylpheni date ( starting at 5 mg/day and increasing to 20 mg/day in a week ) , sertraline ( starting at 25 mg/day and increasing to 100 mg/day in a week ) or placebo . At the baseline and at the 4 week endpoint , the following assessment s were administered : subjective ( Beck Depression Inventory ) and objective ( Hamilton Depression Rating Scale ) measures of depression ; Rivermead Postconcussion Symptoms Question naire for postconcussional symptoms ; SmithKline Beecham Quality of Life Scale for quality of life ; seven performance tests ( Critical Flicker Fusion , Choice Reaction Time , Continuous Tracking , Mental Arithmetic , Short-Term memory , Digit Symbol Substitution and Mini-Mental State Examination ) ; subjective measures of sleep ( Leeds Sleep Evaluation Question naire ) and daytime sleepiness ( Epworth Sleepiness Scale ) . All adverse events during the study period were recorded and their relationships to the drugs were assessed . RESULTS Neuropsychiatric sequelae seemed to take a natural recovery course in patients with traumatic brain injury . Methylpheni date had significant effects on depressive symptoms compared with the placebo , without hindering the natural recovery process of cognitive function . Although sertraline also had significant effects on depressive symptoms compared with the placebo , it did not improve many tests on cognitive performances . Daytime sleepiness was reduced by methylpheni date , while it was not by sertraline . CONCLUSIONS Methylpheni date and sertraline had similar effects on depressive symptoms . However , methylpheni date seemed to be more beneficial in improving cognitive function and maintaining daytime alertness . Methylpheni date also offered a better tolerability than sertraline Objective : Evaluate the association between neuroendocrine findings and fatigue after traumatic brain injury ( TBI ) Research design : Prospect i ve , observational . Methods and procedures : Sixty-four individuals at least 1 year post-TBI underwent neuroendocrine testing including thyroid , adrenal , gonadal axes and growth hormone ( GH ) after glucagon stimulation with assessment of fatigue using the Global Fatigue Index ( GFI ) and the Fatigue Severity Scale ( FSS ) . Main outcomes and results : GFI and FSS scores were significantly higher within this sample compared to published control data . At least one pituitary axis was abnormal in 90 % of participants . Higher GH levels were significantly associated with higher FSS scores . There was a noted trend between lower basal cortisol and higher scores on both the FSS and GFI . Conclusions : The association between higher GH levels and greater fatigue contradicted the prevailing hypothesis that post-acute TBI fatigue is associated with GH deficiency . The association between lower basal cortisol and greater fatigue was in the expected direction . While no other trends were noted , the fatigue derived from neuroendocrine abnormalities alone may be masked by fatigue induced by other factors commonly experienced following TBI . Given the high prevalence of pituitary abnormalities , screening for hypopituitarism after TBI is a reasonable recommendation . The contribution of GH deficiency to diminished quality of life post-TBI remains unclear Objective : The purpose was to establish the frequency of insomnia within the post-acute TBI population and compare it with insomnia rates among other rehabilitation out patients . Design : A prospect i ve study was undertaken of 50 consecutive post-acute TBI admissions and a comparison group of 50 rehabilitation out patients evenly divided between spinal cord injury ( SCI ) and musculoskeletal ( MSK ) cases . Setting : Subjects were recruited at various outpatient clinics of a major rehabilitation hospital . Patients : Among the TBI subjects , the predominant cause of injury was motor vehicle accident ; both mild and severe injuries were well represented in the sample ; and , on average , patients were almost 4 months post-injury . The comparison and TBI groups did not differ significantly with respect to education or marital status . However , the MSK group was older and a higher proportion of the SCI group was female . Measures : The Pittsburgh Sleep Quality Index ( PSQI ) , Beck Depression Inventory ( BDI ) , and sleep diaries were administered to the TBI group . Only the PSQI and BDI were completed by the comparison group . Results : Thirty per cent of the patients were found to suffer from insomnia . Sleep initiation was a problem almost twice as often as sleep duration . An additional 12 % did not meet the DSM-IV criteria for insomnia but , nevertheless , experienced a degradation of sleep quality , as measured by the PSQI . Conversely , only slightly more than half ( 58 % ) of the TBI sample reported sleep to be relatively normal and satisfactory . Insomnia was also commonly reported by the patients in the rehabilitation comparison groups . They generated significantly higher mean PSQI Global Scores relative to the TBI group and the frequency of poor sleep quality was elevated significantly above the TBI rate . Relative to the TBI cases , twice as many comparison group patients were classified by the PSQI as insomniacs . Conclusion : Poor sleep quality and insomnia were definitely problems for the TBI group , although the magnitude of these problems was much greater for the rehabilitation comparison group . De grade d and disordered sleep may represent widespread challenges within
Output:
| The Pittsburgh sleep quality index and Epworth sleepiness scale were partially vali date d in post-acute TBI .
Although no instrument has been specifically developed for TBI patients , there are scientific benefits to using the existing measures . |
MS213576 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Orthodontic records- study models , panoramic and cephalometric radiographs , and the patient 's facial and intraoral photographs-are used to collect data to establish a diagnosis and to develop problem-solution lists . These records , however , can be damaged or lost when dispensed to students and need to be stored and maintained every year . An orthodontic diagnosis web site , therefore , has been set up using digital records to provide students with an accessible source of complete , good- quality study material s. The web site is also used for clinical examination in orthodontic courses . The effectiveness of the web-based digital records in providing relevant information to students in comparison to the traditional records was evaluated by a r and omized controlled trial involving ninety-nine second-year dental students . One group ( fifty students ) studied two cases from the web site ; the other group ( forty-nine students ) studied the same two cases from traditional orthodontic records . Effectiveness was assessed by comparing test scores and the time spent on the tests by t-statistics . There were no significant differences between means for the two study groups in test performance or time . Attitudes of students toward the web site , assessed from post-test question naires , were positive . It was concluded that web-based digital orthodontic records were as effective in teaching clinical orthodontic diagnosis as were conventional records Aim The aim of this study was to compare the effectiveness of a computer assisted learning ( CAL ) programme with that of traditional small group tutorials in teaching theoretical and practical aspects of periodontal pocket charting . Method Sixty-one third year undergraduate dental students were r and omized to either receive a tutorial or to work through the CAL programme . Students using the CAL programme completed question naires relating to previous computer experience and the ease of use of the programme . All students were assessed immediately after the intervention by means of a confidence log , a practical exercise and a further confidence log . They were assessed again three weeks later by means of a confidence log and a multiple-choice written test . Results There were very few significant differences between groups for any of the assessment s used . However , subjective comments indicated that students occasionally felt disadvantaged if they had not received a tutorial . Conclusion CAL and traditional teaching methods are equally effective in teaching periodontal pocket charting to undergraduate dental students AIM The aim of this study was to evaluate the place of computer-aided learning in a basic science course in the undergraduate medical curriculum at the University of Adelaide . METHODS A software program was written which would allow students to study the anatomy and physiology of the liver and biliary tree in three different styles . Identical content was produced , matched for each style ( problem-based , didactic and free text response ) and students r and omly allocated to one of four groups ( three computer and one control ) . Students were tested before and after access to the program . RESULTS Ninety second-year students completed the study . Those students who had access to the material in the problem-based and free text response styles did no better in the post- study test than the controls , whilst the group who had studied the didactically presented computer material performed significantly better than the other three groups . All three computer groups accessed the material on a similar number of occasions , but the group who had access to the free text entry program spent significantly less time on computer study . CONCLUSIONS If computer material s are to be provided as a learning re source for the basic medical sciences , provision must be made for the style of teaching of the course and the style of learning of the students attending that course Hypertext is a non-linear method of text presentation . It necessitates the use of a computer to store data as a series of nodes that can be called up in any desired sequence and , as such , is a new form of discovery-based learning . This paper describes a Hypertext tutorial in cephalometrics and its subsequent testing on first-year clinical dental students . Students were divided into two groups : the first received a conventional lecture ; the second used the Hypertext tutorial . Testing was by means of conventional multiple choice questions . The results showed that there was no statistically significant difference between the two groups , although the computer tutor was shown more consistently to improve the knowledge of the students than did the conventional lecture . Most students who used the computer program found it enjoyable , but time consuming ; less than half found it easy to follow
Output:
| Overall , student attitudes were positive towards CAL .
No conclusions can be drawn about the time efficiency of CAL . |
MS213577 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND The need for patella resurfacing remains an area of considerable controversy in total knee replacement surgery . There would appear to be no reported evidence on the effect of patella resurfacing on knee function , as measured by functional range of movement used in a series of tasks , in patients undergoing knee replacement . The object of this study was to measure knee joint motion during functional activities both prior to and following total knee replacement in a r and omised group of patients with and without patella resurfacing and to compare these patient groups with a group of normal age-matched subjects . METHODS The study design was a double blinded , r and omised , prospect i ve , controlled trial . The knee joint functional ranges of movement of a group of patients ( n=50 , mean age=70 years ) with knee osteoarthritis were investigated prior to and following total knee arthroplasty ( 4 months and 18 - 24 months ) along with a group of normal subjects ( n=20 , mean age=67 ) . Patients were r and omly allocated into two groups , those who received patella resurfacing ( n=25 ) and those who did not ( n=25 ) . Flexible electrogoniometry was used to measure the flexion-extension angle of the knees with respect to time in eleven functional activities . FINDINGS No statistically significant differences ( alpha level 0.05 ) in joint excursion of the affected knee were found between patients who received patella resurfacing and those who did not . INTERPRETATION Routine patella resurfacing in a typical knee arthroplasty population does not result in an increase in the functional range of movement used after knee replacement Abstract Objective To examine the extent and nature of outcome reporting bias in a broad cohort of published r and omised trials . Design Retrospective review of publications and follow up survey of authors . Cohort All journal articles of r and omised trials indexed in PubMed whose primary publication appeared in December 2000 . Main outcome measures Prevalence of incompletely reported outcomes per trial ; reasons for not reporting outcomes ; association between completeness of reporting and statistical significance . Results 519 trials with 553 publications and 10 557 outcomes were identified . Survey responders ( response rate 69 % ) provided information on unreported outcomes but were often unreliable — for 32 % of those who denied the existence of such outcomes there was evidence to the contrary in their publications . On average , over 20 % of the outcomes measured in a parallel group trial were incompletely reported . Within a trial , such outcomes had a higher odds of being statistically non-significant compared with fully reported outcomes ( odds ratio 2.0 ( 95 % confidence interval 1.6 to 2.7 ) for efficacy outcomes ; 1.9 ( 1.1 to 3.5 ) for harm outcomes ) . The most commonly reported reasons for omitting efficacy outcomes included space constraints , lack of clinical importance , and lack of statistical significance . Conclusions Incomplete reporting of outcomes within published articles of r and omised trials is common and is associated with statistical non- significance . The medical literature therefore represents a selective and biased subset of study outcomes , and trial protocol s should be made publicly available Complications of patellar resurfacing in total knee arthroplasty have rekindled the interest of many surgeons in patellar retention . In a prospect i ve study 20 r and omly selected patients of 40 underwent patellar resurfacing in combination with their total knee arthroplasty . The other 20 patients were left with an unresurfaced patella . Within 24 months of follow-up , the advantages of patellar resurfacing could be seen according to the Knee Society Score . Especially in advanced osteoarthritis of the knee joint , the patients achieved better scores in climbing stairs and in function . The superior functional results are arguments for patellar resurfacing , at least in knees with advanced osteoarthritis OBJECTIVE The aim is of this prospect i ve r and omised study was to investigate the necessity of resurfacing the patella in combination with total knee arthroplasty in patients without or mild anterior knee pain before undergoing total knee replacement . METHODS Between May 1999 and May 2000 fifty patients were enrolled in a prospect i ve , r and omised study . All patients received the same posterior-cruciate-sparing total knee replacement and were r and omised to treatment with and without resurfacing of the patella . Inclusion criteria were primary osteoarthritis of the knee , preoperatively no pain when the patella was shifted during clinical examination , a maximal grade III radiological degeneration of the patella according to Sperner et al. and at most a mild anterior knee pain in preoperative interview . Evaluations consisted of the determination of the Knee Society clinical score , the completion of a patient satisfaction question naire , and radiographic assessment basing on the Knee Society roentgenographic evaluation and scoring system . All patients were examined preoperatively and 3 , 6 , and 12 months postoperatively . RESULTS In all postoperative examinations patients with patella resurfacing demonstrated a higher overall Knee Society score . At month 6 the difference was statistically significant . The patient satisfaction question naire demonstrated no significant difference between both groups . However , regarding to relief of anterior knee pain and improvement of pain in general patients with nonresurfacing were less satisfied at all follow-ups . Furthermore , after 12 months all answers to the patient satisfaction question naire of the resurfaced group were better . Patella-associated revisions were performed in two patients without resurfacing . Radiographic analysis demonstrated no loosening , fracture , subluxation or dislocation . CONCLUSION The presented study demonstrated after one year follow-up a better functional result , a higher degree of contentment and fewer complications after total knee replacement with patella resurfacing in patients without or mild preoperative anterior knee pain Background : Whether to resurface the patella during a primary total knee arthroplasty performed for the treatment of degenerative osteoarthritis remains a controversial issue . Parameters that have been suggested as being useful in guiding this decision include patient height and weight , the presence of anterior knee pain preoperatively , and the grade of chondromalacia encountered intraoperatively . The purpose of this study was to determine whether these parameters were predictive of the clinical result following total knee arthroplasty with or without patellar resurfacing . Methods : Eighty-six patients ( 118 knees ) undergoing primary total knee arthroplasty for the treatment of osteoarthritis were enrolled in a prospect i ve , r and omized , double-blind study . All patients received the same posterior-cruciate-sparing total knee prosthetic components . Patients were r and omized to treatment with or without resurfacing of the patella . Evaluations consisted of the determination of a Knee Society clinical score , the completion of a patient satisfaction question naire , specific questions relating to patellofemoral symptoms , and radiographs . Sixty-seven patients ( ninety-three knees ) were followed for a minimum of five years ( range , sixty to eighty-four months ; average , 70.5 months ) . Results : With the numbers available , there was no significant difference between the groups treated with and without resurfacing with regard to the overall Knee Society score or the pain and function subscores . Obesity , the degree of patellar chondromalacia , and the presence of preoperative anterior knee pain did not predict postoperative clinical scores or the presence of postoperative anterior knee pain . Conclusions : The occurrence of anterior knee pain could not be predicted with any clinical or radiographic parameter studied . On the basis of these results , it seems likely that postoperative anterior knee pain is related either to the component design or to the details of the surgical technique , such as component rotation , rather than to whether or not the patella is resurfaced Summary We suggest a three-step approach when using an article from the surgical literature to guide your patient care : ( 1 ) assess whether the study can provide valid results , ( 2 ) review the results , and ( 3 ) consider how the results might be applied to your patient . R and omization , concealment , intention-to-treat analysis , similarity of patients for known prognostic factors , blinding of patients and outcome assessors , and completeness of follow-up are important guides to study validity . The 95 % confidence interval around the treatment effect is a measure of precision . Consider whether all of the clinical ly important outcomes were reported and whether the likely benefits of treatment outweigh the potential harm and costs Patellofemoral problems are a common cause of morbidity and reoperation after total knee arthroplasty . We made a prospect i ve study of 52 patients who had bilateral arthroplasty ( 104 knees ) and in whom the patella was resurfaced on one side and not on the other . A movable-bearing prosthesis with an anatomical femoral groove was implanted on both sides by the same surgeon using an otherwise identical technique . The mean follow-up was 5.24 years ( 2 to 10 ) . In the 30 available patients ( 60 knees ) there was no difference between the two sides in subjective preference , performance on ascending and descending stairs or the incidence of anterior knee pain . Radiographs showed no differences in prosthetic alignment , femoral condylar height , patellar congruency or joint line position . The use of an appropriate prosthetic design and careful surgical technique can provide equivalent results after knee arthroplasty with or without patellar resurfacing . Given the indications and criteria , which we discuss , retention of the patellar surface is an acceptable option To find out the improvement of joint position sense after total knee arthroplasty with patellar resurfacing compared to total knee arthoplasty without patellar resurfacing , the study was carried out as a r and omised parallel trial in patients who had stage III and IV primary osteoarthrosis of only 1 side of the knee with a 2 year follow-up . Twenty-one patients underwent patellar resurfacing and 26 patients had no patellar resurfacing . Joint position sense was evaluated by the average absolute different angle of the operated knees from the non operated knees which was the asymptomatic knee and acted as the reference knee . Position sense was improved significantly in both groups . However , the patients without patellar resurfacing had better improvement . The patients with patellar resurfacing had better results in terms of anterior knee pain and tenderness . Patellar resurfacing should be used in severe articular cartilage damage , not as a routine operation Patellar resurfacing in total knee arthroplasty remains controversial . This study evaluates the results of resurfacing and nonresurfacing the patella in a r and omized controlled , clinical trial at a minimum of 10 years followup . One hundred knees ( 90 patients ) with osteoarthritis were enrolled in a prospect i ve r and omized clinical trial using a posterior – cruciate-retaining total knee arthroplasty . Patients were r and omized to receive resurfacing or retention of the patella . Evaluations were done preoperatively and yearly , up to a minimum of 10 years ( range , 10.1–11.5 years ) postoperatively . Disease-specific ( Knee Society clinical rating score ) and functional ( stair climbing , flexion/extension torques , patellar examination ) outcomes were measured . Patient satisfaction , anterior knee pain , and patellofemoral question naires were completed . Intraoperative grading of the articular cartilage was done . No patients were lost to followup ; 45 patients remained alive . Nine revisions ( in nine of 90 knees ; 10 % ) were done in seven patients in the nonresurfaced group ( 15 % of knees ) and in two patients in the resurfaced group ( 5 % of knees ) . No significant difference was found between the groups regarding revision rates , Knee Society clinical rating scores , and functional , patient satisfaction , anterior knee pain , patellofemoral , and radiographic outcomes . Intraoperative cartilage quality was not a predictor of outcome . This study currently is the longest followup of a r and omized controlled , clinical trial that examines patellar resurfacing in total knee arthroplasty . The results showed no significant difference between the groups for all outcome measures at a minimum of 10 years of followup Patellar resurfacing in total knee arthroplasty is a topic debated in the literature . Concerns include fracture , dislocation , loosening , and extensor mechanism injury . Residual anterior knee pain has been reported when the patella is not resurfaced . One hundred patients with osteoarthritic knees were prospect ively r and omized to either have their patella resurfaced or left not resurfaced . All patients were treated with a single prosthesis that featured an anatomically design ed patellofemoral articulation ( Anatomic Medullary Knee , DePuy , Warsaw , IN ) Two patients in the unresurfaced group and one in the resurfaced group required repeat surgery for patellofemoral complications . At 8- to 10-year follow-up evaluations , Knee Society Clinical Ratings scores were not different between the 2 groups . Rates of anterior knee pain with walking and stair climbing were significantly less in the resurfaced group . Eighty percent of patients with a resurfaced patella were extremely satisfied with their total knee arthroplasty versus 48 % without patellar resurfacing . When satisfied and extremely satisfied patients were grouped together , there was no difference between the 2 groups A series of 100 consecutive osteoarthritic patients was r and omised to undergo total knee replacement using a Miller-Galante II prosthesis , with or without a cemented polyethylene patellar component . Knee function was evaluated using the American Knee Society score , Western Ontario and McMaster University Osteoarthritis index , specific patellofemoral-related questions and radiographic evaluation until the fourth post-operative year , then via question naire until ten years post-operatively . A ten
Output:
| The evidence suggests that patellar resurfacing would reduce the risk of anterior knee pain , as well as the risk of patella-related reoperation .
Furthermore , patients not undergoing patella resurfacing would experience more knee pain during stair climbing and be less satisfied with surgery .
No significant difference in range of motion can be expected with or without patellar resurfacing . |
MS213578 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background and Purpose — Ultrasound of carotid arteries provides measures of intima media thickness ( IMT ) and plaque , both widely used as surrogate measures of cardiovascular disease . Although IMT and plaques are highly intercorrelated , the relationship between carotid plaque and IMT and cardiovascular disease has been conflicting . In this prospect i ve , population -based study , we measured carotid IMT , total plaque area , and plaque echogenicity as predictors for first-ever myocardial infa rct ion ( MI ) . Methods — IMT , total plaque area , and plaque echogenicity were measured in 6226 men and women aged 25 to 84 years with no previous MI . The subjects were followed for 6 years and incident MI was registered . Results — During follow-up , MI occurred in 6.6 % of men and 3.0 % of women . The adjusted relative risk ( RR ; 95 % CI ) between the highest plaque area tertile versus no plaque was 1.56 ( 1.04 to 2.36 ) in men and 3.95 ( 2.16 to 7.19 ) in women . In women , there was a significant trend toward a higher MI risk with more echolucent plaque . The adjusted RR ( 95 % CI ) in the highest versus lowest IMT quartile was 1.73 ( 0.98 to 3.06 ) in men and 2.86 ( 1.07 to 7.65 ) in women . When we excluded bulb IMT from analyses , IMT did not predict MI in either sex . Conclusions — In a general population , carotid plaque area was a stronger predictor of first-ever MI than was IMT . Carotid atherosclerosis was a stronger risk factor for MI in women than in men . In women , the risk of MI increased with plaque echolucency Abstract — Plasma levels of C-reactive protein ( CRP , a marker of the reactant plasma protein component of the inflammatory response ) and of fibrin D-dimer ( a marker of cross-linked fibrin turnover ) have each been associated in recent studies with the risk of future ischemic heart disease ( IHD ) . Previous experimental studies have shown that fibrin degradation products , including D-dimer , have effects on inflammatory processes and acute-phase protein responses . In the Speedwell Prospect i ve Study , we therefore measured CRP and D-dimer levels in stored plasma sample s from 1690 men aged 49 to 67 years who were followed-up for incident IHD for an average of 75±4 months ( mean±SD ) and studied their associations with each other , with baseline and incident IHD , and with IHD risk factors . CRP and D-dimer levels were each associated with age , plasma fibrinogen , smoking habit , and baseline evidence of IHD . CRP was associated with D-dimer ( r = 0.21 , P < 0.00001 ) . On univariate analyses , both CRP and D-dimer were associated with incident IHD . The incidence of IHD increased with CRP independently of the level of D-dimer ( P = 0.0002 ) and also increased with D-dimer independently of the level of CRP ( P = 0.048 ) . In multivariate analyses , inclusion of D-dimer and conventional risk factors reduced the strength of the association between CRP and incident IHD ; likewise , inclusion of CRP and conventional risk factors reduced the strength of the association between D-dimer and incident IHD . We conclude that although these respective markers of inflammation and fibrin turnover show modest association with each other in middle-aged men , they may have additive associations with risk of incident IHD . Further larger studies are required to test this hypothesis BACKGROUND A high serum total homocysteine ( tHcy ) concentration is a risk factor for death , but the strength of the relation in patients with type 2 ( non-insulin-dependent ) diabetes mellitus compared with nondiabetic subjects is not known . A cross-sectional study suggested that the association between tHcy and cardiovascular disease is stronger in diabetic than in nondiabetic subjects . We therefore prospect ively investigated the combined effect of hyperhomocysteinemia and type 2 diabetes on mortality . METHODS AND RESULTS Between October 1 , 1989 , and December 31 , 1991 , serum was saved from 2484 men and women , 50 to 75 years of age , who were r and omly selected from the town of Hoorn , The Netherl and s. Fasting serum tHcy concentration was measured in 171 subjects who died ( cases ; 76 of cardiovascular disease ) and in a stratified r and om sample of 640 survivors ( control subjects ) . Mortality risks were calculated over 5 years of follow-up by means of logistic regression . The prevalence of hyperhomocysteinemia ( tHcy > 14 micromol/L ) was 25 . 8 % . After adjustment for major cardiovascular risk factors , serum albumin , and HbA(1c ) , the odds ratio ( 95 % CI ) for 5-year mortality was 1.56 ( 1.07 to 2.30 ) for hyperhomocysteinemia and 1.26 ( 1.02 to 1 . 55 ) per 5-micromol/L increment of tHcy . The odds ratio for 5-year mortality for hyperhomocysteinemia was 1.34 ( 0.87 to 2.06 ) in nondiabetic subjects and 2.51 ( 1.07 to 5.91 ) in diabetic subjects ( P=0.08 for interaction ) . CONCLUSIONS Hyperhomocysteinemia is related to 5-year mortality independent of other major risk factors and appears to be a stronger ( 1.9-fold ) risk factor for mortality in type 2 diabetic patients than in nondiabetic subjects In this nested case-control study , lipoprotein ( a ) [ Lp(a ) ] concentrations and apo(a ) isoform size were measured in serum sample s obtained from men participating in the prospect i ve Multiple Risk Factor Intervention Trial ( MRFIT ) . Serum from men aged 35 to 57 years and stored for up to 20 years were analyzed for Lp(a ) levels ( n=736 ) and isoform size ( n=487 ) , respectively . Cases involved nonfatal myocardial infa rct ions ( MI ; n=98 ) , documented during the active phase of the study that ended on February 28 , 1982 and coronary heart disease ( CHD ) deaths ( n=148 ) monitored through 1990 . Median Lp(a ) levels did not differ between cases and controls and mean apo(a ) size did not vary between cases and controls in the entire study population . When adjusted for age and Lp(a ) concentration , logistic regression analysis indicated that small apo(a ) isoforms were associated with CHD deaths among smokers ( OR 3.31 ; 95 % CI 1.07 - 10.28 ) BACKGROUND Epidemiologic studies have shown that C-reactive protein ( CRP ) is a risk factor for coronary heart disease . Whether routine measurement of CRP has a role in the prediction of future coronary disease in everyday clinical practice has not yet been investigated . METHODS Within the Rotterdam Study , a population -based cohort study of 7983 men and women 55 years and older , we conducted a nested case-control study to investigate the value of CRP in coronary disease prediction . Data are based on 157 participants who experienced a myocardial infa rct ion during follow-up and 500 r and omly selected controls . High-sensitivity CRP and traditional cardiovascular risk factors were measured at baseline . RESULTS The age- and sex-adjusted relative risk of myocardial infa rct ion for subjects in the highest quartile of the population distribution of CRP compared with the lowest quartile was 2.0 ( 95 % confidence interval , 1.1 - 3.4 ) . After additional adjustment for traditional cardiovascular risk factors , the increase in risk largely disappeared ( odds ratio , 1.2 ; 95 % confidence interval , 0.6 - 2.2 ) . Adding CRP to a coronary disease risk function based on risk factors that are routinely assessed in clinical practice or to the Framingham risk function did not improve the area under the receiver operating characteristic curve of these risk functions . Sensitivity and specificity of both risk functions , computed after dichotomizing the estimated disease probabilities using prespecified cutoff points , hardly improved when CRP was added . CONCLUSION Measurement of CRP in elderly people has no additional value in coronary disease risk prediction when traditional cardiovascular risk factors are known BACKGROUND We examined the relationship between granulocyte , lymphocyte and monocyte counts and risk of coronary heart disease ( CHD ) and cardiovascular disease ( CVD ) in men and women . There is paucity of data on the differential leucocyte count and its relationship with the risk of CHD and CVD . METHODS This prospect i ve study comprised 7073 men and 9035 women who were 45 - 79 years of age and were residents of Norfolk . United Kingdom . RESULTS During an average of 8 years of follow-up we identified 857 incident CHD events and 2581 CVD incident events . Increased total leucocyte count was associated with increased risk for both CHD and CVD . The highest quartile of granulocyte count was associated with increased risk when compared to lowest quartile for CHD ( men HR 1.70 95 % CI : 1.30 - 2.21 ; women HR 1.24 95 % CI : 0.91 - 1.69 ) and for CVD ( men HR 1.46 95 % CI : 1.24 - 1.71 ; women HR 1.20 95 % CI : 1.02 - 1.42 ) . The association remained unchanged when the analyses were restricted to nonsmokers and when risk was assessed for every 1000 cells L(-1 ) increase in cell count . In multivariable models , despite adjusting for C-reactive protein ( CRP ) , the granulocyte count remained an independent predictor of CHD and CVD risk , especially amongst men . Lymphocyte or monocyte counts were not significantly associated with increased risk . In all analyses , additionally adjusting for CRP did not affect the results material ly . CONCLUSIONS In conclusion , we found that the higher risk for CHD and CVD associated with increased total leucocyte count seems to be accounted for by the increased granulocyte count The relation of serum total homocysteine and lipoprotein(a ) ( Lp(a ) ) with the incidence of atherosclerotic disease was investigated among 7424 men and women aged 40 - 64 years free of atherosclerotic disease at baseline in 1977 . During the 9-year follow-up , 134 male and 131 female cases with either myocardial infa rct ion or stroke were identified . For each case a control subject was selected belonging to the same sex and 5-year age group . Serum sample s collected in 1977 were stored at -20 degrees C and analyzed in 1991 . The mean serum homocysteine concentration of male cases and controls was 9.99 mumol/l and 9.82 mumol/l at baseline and that of female cases and controls 9.58 mumol/l and 9.24 mumol/l , respectively . The median serum Lp(a ) concentration of male cases and controls was 73 mg/l and 108 mg/l and that of female cases and controls 113 mg/l and 91 mg/l , respectively . The differences between cases and controls were not statistically significant . There was also no significant association between either homocysteine or Lp(a ) and atherosclerotic disease , myocardial infa rct ion or stroke in logistic regression analyses . The odds ratios varied from 1.00 to 1.26 for homocysteine and from 0.81 to 1.06 for Lp(a ) . The results of this prospect i ve population -based study do not support the hypotheses that serum homocysteine or Lp(a ) are risk factors for atherosclerotic disease . The lack of association between serum homocysteine and atherosclerotic disease may be due to the exceptionally low gene frequency predisposing to homocysteinemia in Finl and In 1998 , the American Heart Association convened Prevention Conference V to examine strategies for the identification of high-risk patients who need primary prevention . Among the strategies discussed was the measurement of markers of inflammation.1 The Conference concluded that “ many of these markers ( including inflammatory markers ) are not yet considered applicable for routine risk assessment because of : ( 1 ) lack of measurement st and ardization , ( 2 ) lack of consistency in epidemiological findings from prospect i ve studies with endpoints , and ( 3 ) lack of evidence that the novel marker adds to risk prediction over and above that already achievable through the use of established risk factors . ” The National Cholesterol Education Program Adult Treatment Panel III Guidelines identified these markers as emerging risk factors,1a which could be used as an optional risk factor measurement to adjust estimates of absolute risk obtained using st and ard risk factors . Since these publications , a large number of peer- review ed scientific reports have been published relating inflammatory markers to cardiovascular disease ( CVD ) . Several commercial assays for inflammatory markers have become available . As a consequence of the exp and ing research base and availability of assays , the number of inflammatory marker tests ordered by clinicians for CVD risk prediction has grown rapidly . Despite this , there has been no consensus from professional societies or governmental agencies as to how these assays of markers
Output:
| This sequential approach provides a direct measure of the number or proportion of intermediate-risk persons who could be reclassified by the new test .
This type of analysis provides the best information about the clinical effect of using the new test to further stratify intermediate-risk patients . |
MS213579 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE Comparison of quality of life ( QoL ) and side effects in a r and omized trial for early hyperbaric oxygen therapy ( HBOT ) after radiotherapy ( RT ) . METHODS AND MATERIAL S From 2006 , 19 patients with tumor originating from the tonsillar fossa and /or soft palate ( 15 ) , base of tongue ( 1 ) , and nasopharynx ( 3 ) were r and omized to receive HBOT or not . HBOT consisted of 30 sessions at 2.5 ATA ( 15 msw ) with oxygen breathing for 90 min daily , 5 days per week , applied shortly after the RT treatment was completed . As of 2005 , all patients received vali date d question naires ( i.e. , the European Organization for Research and Treatment of Cancer [ EORTC ] QLQ-C30 , EORTC QLQ Head and Neck Cancer Module ( H&N35 ) , Performance Status Scale ) : before treatment ; at the start of RT treatment ; after 46 Gy ; at the end of RT treatment ; and 2 , 4 , and 6 weeks and 3 , 6 , 12 , and 18 months after follow-up . RESULTS On all QoL items , better scores were obtained in patients treated with hyperbaric oxygen . The difference between HBOT vs. non-HBOT was significant for all parameters : EORTC H&N35 Swallowing ( p = 0.011 ) , EORTC H&N35 Dry Mouth ( p = 0.009 ) , EORTC H&N35 , Sticky Saliva ( p = 0.01 ) , PSS Eating in Public ( p = 0.027 ) , and Pain in Mouth ( visual analogue scale ; p < 0.0001 ) . CONCLUSIONS Patients r and omized for receiving hyperbaric oxygen after the RT had better QoL scores for swallowing , sticky saliva , xerostomia , and pain in mouth Although hyperbaric oxygen is used to treat chronic radiation tissue injury , clinical evidence supporting its efficacy has been limited to date . The authors report prospect ively collected patient outcomes from a single center 's large experience using hyperbaric oxygen to treat chronic radiation injury The aim of this study was to evaluate the effect of hyperbaric oxygen therapy ( HBOT ) on microvascular tissue and cell proliferation in the oral mucosa . Twenty patients , aged 51 - 78 years , were allocated r and omly to a treatment or a control group . All had a history of radiotherapy ( 50 - 70 Gy ) to the orofacial region 2 - 6 years previously . Tissue sample s were taken from the irradiated buccal oral mucosa before HBOT and at 6 months after treatment . In the control group , tissue sample s were taken on two occasions , 6 months apart . The sample s were subjected to immunohistochemistry staining : double staining with CD31 and D2 - 40 for microvessels , or Ki-67 for the analysis of cell proliferation . Blood vessel density and area were significantly increased after HBOT ( P=0.002 - 0.041 ) . D2 - 40-positive lymphatic vessels were significantly increased in number and area in the sub-epithelial area ( P=0.002 and P=0.019 , respectively ) . No significant differences were observed in the control group . There were no significant differences in Ki-67-expressing epithelial cells between the two groups . It is concluded that the density and area of blood and lymphatic vessels in the irradiated mucosa are increased by HBOT 6 months after therapy . Epithelial cell proliferation is not affected by HBOT Surgical treatment of malignancies in the oral cavity and subsequent radiotherapy often result in an anatomic and physiological oral condition unfavorable for prosthodontic rehabilitation . The objective of this prospect i ve study was to assess the effect of hyperbaric oxygen therapy on treatment outcome ( condition of peri-implant tissues , implant survival , oral functioning and quality of life ) of prosthodontic rehabilitation with implant-retained lower dentures in radiated head and neck cancer patients 6 weeks and 1 year after placing the new dentures . The treatment outcome was assessed in a group of 26 head neck cancer patients who were subjected to radiotherapy after tumour surgery . St and ardized question naires were completed and clinical and radiographic assessment s were performed . After r and omization , endosseous Brånemark implants were placed in the anterior part of the m and ible either under antibiotic prophylaxis ( 13 patients ) or under antibiotic prophylaxis combined with pre and postsurgery hyperbaric oxygen ( HBO ) treatment ( 13 patients ) . In the HBO and non-HBO group eight implants ( implant survival 85.2 % ) and three implants ( implant survival 93.9 % ) were lost , respectively . Peri-implant tissues had a healthy appearance in both groups . Osteoradionecrosis developed in one patient in the HBO group . All patients functioned well with their implant-retained lower denture . The quality of life related to oral functioning and denture satisfaction were improved to a comparable extent in the HBO and non-HBO group . Implant-retained lower dentures can improve the quality of life related to oral functioning and denture satisfaction in head and neck cancer patients . Adjuvant hyperbaric oxygen therapy could not be shown to enhance implant survival in radiated m and ibular jaw bone Significant challenges are faced by the oral and and a variety of donor sites available to the surgical maxillofacial reconstructive surgeon . As health care professionals , we are in a constant search for excellence in patient care , education , and research . The objective of this issue of the Oral and Maxillofacial Surgery Clinics of North America is to address the needs of a continually evolving specialty , combined with the stated goal of expected excellence . Rehabilitation of the facial structures is a complex task . Optimal treatment requires the achievement of multiple reconstructive goals : oral competence , effective mastication , functional deglutition , preservation of speech , and an acceptable cosmetic appearance . When we assess the cosmetic needs of a patient , we should address symmetry , color , texture , strength , sensibility , and motor innervation of the tissues to be replaced . Appropriate choice of the harvest site is key in the decision process . We can reach these stated objectives through a systematic prospect i ve analysis by using outcome measures . The goal of academic surgery is to translate research into education and delivery of care . Successful clinical outcomes can be applied to maximize patient management . The success of translational research in the area of reconstruction has result ed in a plethora of Purpose : Analysis of the feasibility and effect of hyperbaric oxygen treatment ( HBO ) on cognitive functioning in patients with cognitive disorders after irradiation of the brain . Patients and Method : Seven patients with cognitive impairment after brain irradiation , with an interval of at least 1.5 years after treatment , were treated with 30 sessions of HBO in a phase I – II study . A comprehensive neuropsychological test battery was performed before treatment , at 3 and 6 months thereafter . Patients were r and omized into an immediate treatment group and a delayed treatment group . The delayed group had a second neuropsychological test at 3 months without treatment in that period and started HBO thereafter . Results : All eligible patients completed the HBO treatment and the extensive neuropsychological testing . One out of seven patients had a meaningful improvement in neuropsychological functioning . At 3 months there was a small , but not significant benefit in neuropsychological performance for the group with HBO compared to the group without HBO treatment . Six out of seven patients eventually showed improvement after HBO in one to nine ( median 2.5 ) of the 31 tests , although without statistical significance . Conclusion : HBO treatment was feasible and result ed in a meaningful improvement of congitive functioning in one out of seven patients . Overall there was a small but not significant improvement . Hintergrund : Es wurden die Durchführbarkeit und Wirksamkeit der hyperbaren Oxygenierung ( HBO ) auf die Gehirnfunktion bei Patienten mit kognitiven Störungen nach Hirnbestrahlung untersucht . Patientengut und Method e : In einer Phase-I/II-Studie wurden sieben Patienten mit kognitiven Störungen nach einem minimalen Intervall von 1,5 Jahren 30 HBO-Beh and lungen unterzogen . Neuropsychologische Tests wurden vor HBO sowie 3 und 6 Monate nach Abschluss der Beh and lung durchgeführt . Patienten wurden r and omisiert in eine sofortige und eine späte Beh and lungsgruppe . Die späte Beh and lungsgruppe wurde nach 3 Monaten zum zweiten Mal neuropsychologisch getestet ohne zwischenzeitliche HBO-Beh and lung . Nach diesem zweiten Test begann in dieser Gruppe die HBO . Ergebnisse : Alle Patienten konnten die vorgeschriebene HBO-Therapie und das umfangreiche neuropsychologische Testprogramm abschließen . Einer von sieben Patienten zeigte eine bedeutsame Verbesserung der neuropsychologischen Funktion . Die HBO-Gruppe zeigte i m Vergleich zu einer nicht mit HBO beh and elten Kontrollgruppe nach 3 Monaten eine leichte , statistisch nicht signifikante Verbesserung . Bei sechs der insgesamt sieben HBO-Patienten waren Verbesserungen nachweisbar in einem bis neun ( median 2,5 ) der 31 Tests , die statistisch jedoch nicht signifikant waren . Schlussfolgerung : HBO ist bei Patienten nach Hirnbestrahlung durchführbar und erzielte bei einem von sieben Patienten eine bedeutsame Verbesserung der kognitiven Funktion . Insgesamt zeigte sich eine leichte , statistisch nicht signifikante Verbesserung der getesteten Hirnfunktionen AIM to evaluate the influence of HBOT to the side effect and quality of life after pelvic radiation . METHODS this is an open r and omized , parallel , prospect i ve study conducted in Department of Obstetrics and Gynecology , Oncology Division and Department of Radiotherapy . Endoscopy procedure was performed in Department of Internal Medicine and tissue biopsy in Department of Pathology Anatomy . The hyperbaric oxygen therapy ( HBOT ) was done in Dr. Mintohardjo , Navy Seal Hospital Jakarta . The side effect was measured using LENT SOMA scale ratio , the quality of life used the Karnofsky score . The difference of two mean was analyzed using student t test . RESULTS of 32 patients undergoing HBOT and 33 patients as control , the ratio of ASE of control group was 44.1+/-28.2 % , HBOT group was 0.7+/-30.1 % ; p<0.001 ; the LSE of control group was 33.6+/-57.6 % , HBOT group was -19.6+/-69.4 % ; p=0.008 . Quality of life of control group after intervention was 4.5+/-10.7 % ; HBOT group was 19.7+/-9.6 % ; p < 0.001 . After 6 months of intervention the quality of life was 2.5+/-16.1 % in the control group , and HBOT group was 15.2+/-14.7 % ; p = 0.007 . CONCLUSION the study showed that HBOT decreased acute and late side effect , also improved the quality of life of patients with proctitis radiation The aim of this study was to evaluate the effect of hyperbaric oxygen therapy ( HBOT ) on vascular function and tissue oxygenation in irradiated facial skin and gingival mucosa . Twenty-two patients , aged 51 - 90 years , were r and omly allocated to a treatment or control group . All had a history of radiotherapy ( 50 - 70 Gy ) to the orofacial region 2 - 20 years previously . Skin and mucosal perfusion were recorded with laser Doppler flowmetry ( LDF ) . Tissue oxygenation was recorded by transcutaneous oximetry ( TcPO(2 ) ) . Measurements were taken before HBOT and 3 and 6 months after a mean of 28 HBOT sessions ( partial pressure of oxygen of 240 kPa for 90 min ) . For control subjects , measurements were taken on two occasions 6 months apart . After HBOT , blood flow in mucosa and skin after heat provocation increased significantly ( P < 0.05 ) . TcPO(2 ) increased significantly in the irradiated cheek ( P < 0.05 ) , but not at reference points outside the field of radiation . There were no differences between the 3- and 6-month follow-ups . In the control group , no significant changes in LDF or TcPO(2 ) were observed . It is concluded that oxygenation and vascular capacity in irradiated facial skin and gingival mucosa are increased by HBOT . The effects persist for at least 6 months PURPOSE Persisting symptomatology after breast-conserving surgery and radiation is frequently reported . In most cases , symptoms in the breast resolve without further treatment . In some instances , however , pain , erythema , and edema can persist for years and can impact the patient 's quality of life . Hyperbaric oxygen therapy was shown to be effective as treatment for late radiation sequelae . The objective of this study was to assess the efficacy of hyperbaric oxygen therapy in symptomatic patients after breast cancer treatment . PATIENTS AND METHODS Forty-four patients with persisting symptomatology after breast-conservation therapy were prospect ively observed . Thirty-two women received hyperbaric oxygen therapy in a multiplace chamber for a median of 25 sessions ( range , 7 - 60 ) . One hundred percent oxygen was delivered at 240 kPa for 90-min sessions , 5 times per week . Twelve control patients received no further treatment . Changes throughout the irradiated breast tissue were scored prior to and after hyperbaric oxygen therapy
Output:
| These small trials suggest that for people with LRTI affecting tissues of the head , neck , anus and rectum , HBOT is associated with improved outcome .
HBOT also appears to reduce the chance of ORN following tooth extraction in an irradiated field .
There was no such evidence of any important clinical effect on neurological tissues .
The application of HBOT to selected participants and tissues may be justified . |
MS213580 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background This pilot r and omized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise , spinal manipulation , and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain , a common morbidity of pregnancy . Methods Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy . Once enrolled , they remained in the study until they had their babies . Women were r and omly allocated into one of three treatment groups using opaque envelopes . The treatment schedule paralleled the prenatal care schedule and women received individualized intervention . Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain . Our primary outcome measure was the Rol and Morris Disability Question naire and our secondary outcome measure was the Numeric Pain Rating Scale . Intention to treat analysis was conducted . For the primary analysis , regression was conducted to compare groups on the outcome measure scores . In a secondary responder analysis , difference in proportions of participants in attaining 30 % and 50 % improvement were calculated . Feasibility factors for conducting a future larger trial were also evaluated such as recruitment , compliance to study protocol s , cost , and adverse events . Results Fifty-seven participants were r and omized into the exercise ( n = 22 ) , spinal manipulation ( n = 15 ) , and Neuro Emotional Technique ( n = 20 ) treatment arms . At least 50 % of participants in each treatment group experienced clinical ly meaningful improvement in symptoms for the Rol and Morris Disability Question naire . At least 50 % of the exercise and spinal manipulation participants also experienced clinical ly meaningful improvement for the Numeric Pain Rating Scale . There were no clinical ly meaningful or statistically significant differences between groups in any analysis . Conclusions This pilot study demonstrated feasibility for recruitment , compliance , safety , and affordability for conducting a larger study in the future . Spinal manipulation and exercise generally performed slightly better than did Neuro Emotional Technique for improving function and decreasing pain , but the study was not powered to detect the between-group differences as statistically significant . Trial registration Clinical Trials.gov ( Identifier : NCT00937365 ) OBJECTIVE Pregnancy-related lumbopelvic pain is a major problem for the majority of pregnant women . Complementary medicine has been used to alleviate pain , and yoga is one of the most commonly chosen alternative methods . The objective of this study was to assess the effectiveness of Hatha yoga in the reduction of lumbopelvic pain in pregnancy . METHODS A r and omized controlled trial with 60 pregnant women ( age range , 14 - 40 years ) who reported lumbopelvic pain at 12 to 32 weeks of gestation was conducted from June 2009 to June 2011 . Pregnant women who had twin pregnancies , had medical restrictions for exercise , used analgesics , and participated in physical therapy were excluded from the study . Pregnant women were divided into two groups : the yoga group , practicing exercises guided by this method , and the postural orientation group , performing st and ardized posture orientation according to instructions provided in a pamphlet . Treatment in each group lasted 10 weeks . A visual analog scale ( VAS ) was used to measure pain intensity . Lumbar pain and posterior pelvic pain provocation tests were used to confirm the presence of pain . Statistical analysis included the Mann-Whitney test , the McNemar test , a paired Wilcoxon test , and analysis of covariance . RESULTS The median pain score was lower in the yoga group ( p<.0058 ) than the postural orientation group . Lumbar pain provocation tests showed a decreased response in relation to posterior pelvic pain provocation tests and a gradual reduction in pain intensity during 10 yoga sessions ( p<.024 ) . CONCLUSIONS The yoga method was more effective at reducing lumbopelvic pain intensity compared with postural orientation Background Previous publications indicate that acupuncture is efficient for the treatment of pelvic girdle pain , PGP , in pregnant women . However , the use of acupuncture for PGP is rare due to insufficient documentation of adverse effects of this treatment in this specific condition . The aim of the present work was to assess adverse effects of acupuncture on the pregnancy , mother , delivery and the fetus/neonate in comparison with women that received stabilising exercises as adjunct to st and ard treatment or st and ard treatment alone . Methods In all , 386 women with PGP entered this controlled , single-blind trial . They were r and omly assigned to st and ard treatment plus acupuncture ( n = 125 ) , st and ard treatment plus specific stabilising exercises ( n = 131 ) or to st and ard treatment alone ( n = 130 ) for 6 weeks . Acupuncture that may be considered strong was used and treatment was started as early as in the second trimester of pregnancy . Adverse effects were recorded during treatment and throughout the pregnancy . Influence on the fetus was measured with cardiotocography ( CTG ) before-during and after 43 acupuncture sessions in 43 women . A st and ardised computerized method to analyze the CTG reading numerically ( Oxford 8000 , Oxford , Engl and ) was used . After treatment , the women rated their overall experience of the treatment and listed adverse events if any in a question naire . Data of analgesia and oxytocin augmentation during labour , duration of labour , frequency of preterm birth , operative delivery , Apgar score , cord-blood gas/acid base balance and birth weight were also recorded . Results There were no serious adverse events after any of the treatments . Minor adverse events were common in the acupuncture group but women rated acupuncture favourably even despite this . The computerized or visually assessed CTG analyses of antenatal recordings in connection with acupuncture were all normal . Conclusion This study shows that acupuncture administered with a stimulation that may be considered strong led to minor adverse complaints from the mothers but had no observable severe adverse influences on the pregnancy , mother , delivery or the fetus/neonate Background : To compare the efficiency of transcutaneous electrical nerve stimulation ( TENS ) with those of exercise and acetaminophen for the treatment of pregnancy-related low back pain ( LBP ) during the third trimester of pregnancy . Methods : This prospect i ve study included 79 subjects ( ≥32 gestational weeks ) with visual analog scale ( VAS ) pain scores ≥5 . Participants were divided r and omly into a control group ( n = 21 ) and three treatment groups [ exercise ( n = 19 ) ; acetaminophen ( n = 19 ) ; TENS ( n = 20 ) ] . The VAS and the Rol and -Morris disability question naire ( RMDQ ) were completed before and 3 weeks after treatment to assess the impact of pain on daily activities . Results : During the study period , pain intensity increased in 57 % of participants in the control group , whereas pain decreased in 95 % of participants in the exercise group and in all participants in the acetaminophen and TENS groups . Post-treatment VAS and RMDQ values were significantly lower in the treatment groups ( p < 0.001 ) . VAS and RMDQ scores indicated a significantly greater degree of pain relief in the TENS group than in the exercise and acetaminophen groups ( p < 0.001 ) . No adverse effect of TENS application on pregnant women was observed during the study . Conclusion : TENS is an effective and safe treatment modality for LBP during pregnancy . TENS improved LBP more effectively than did exercise and acetaminophen Background . Low back and pelvic pain is common in pregnancy and postpartum , but there is no well documented effect of treatment in pregnancy . The aim of the study was to assess whether a group intervention program for pregnant women with pelvic girdle pain has any effect on pain and daily function postpartum . Methods . Pregnant women with pelvic pain between the 18th and 32nd week of gestation were invited to participate in a r and omized clinical study . Among 958 examined women , 569 ( 59 % ) fulfilled the inclusion criteria . Women r and omized to the intervention group ( n = 275 ) participated in an education program that consisted of information , ergonomics , exercises , pain management , advice for daily life movement , pelvic belt/crutches , and information about delivery . Women r and omized to the control group ( n = 285 ) were not offered any treatment , but were free to seek advice or other treatment . Clinical measures and self‐evaluated utility of the intervention were measured by a visual analogue scale 0–10 . Results . Mean debut of pelvic girdle pain in pregnancy was at week 15 . Altogether 42 % of the women reported problems with low back pain earlier , and 34 % reported a family history of pelvic girdle pain in pregnancy . Median visual analogue scale score for all activities at inclusion was 6 both in the control group and the intervention group . At 6 and 12 months postpartum the score was reduced to 1.7/1.6 and 1.1/0.9 . In the intervention group , 75 % marked a self‐evaluated utility visual analogue scale score > 7 . In the control group , 60 % had search ed for alternative treatment . Conclusions . Postpartum pelvic girdle pain improved with time both in the intervention group and the control group , but there were no statistically significant differences between the groups . Self‐evaluated utility of the intervention was , however , high in the intervention group OBJECTIVE To investigate the effect of an exercise program , including specific stabilizing exercises , on pain intensity and functional ability in women with pregnancy-related low back pain . METHODS Fifty women between 16 and 24 weeks of pregnancy were recruited at Tygerberg and Paarl Hospitals , Western Cape , South Africa . Twenty-six women were r and omized to a 10-week exercise program and 24 were r and omized as controls . RESULTS Overall , the most frequent type of back pain experienced was lumbar pain ( 36 [ 72.0 % ] ) . Pain intensity ( P=0.76 ) and functional ability ( P=0.29 ) were comparable between the groups on study entry . In the study group , there was a significant improvement in pain intensity ( P<0.01 ) and an improvement in functional ability ( P=0.06 ) at the end of the study . In the control group , there were no significant changes in pain intensity ( P=0.89 ) or functional ability ( P=0.70 ) at the end of the study . CONCLUSION A specific exercise program decreased back pain intensity and increased functional ability during pregnancy in South African women with lumbar and pelvic girdle pain Background For the moment , scientific evaluation of programs on treatment of pregnancy-related pelvic girdle and /or low back pain after delivery is hardly available with only one study with a positive result , suggesting uncertainty about the optimal approach . Investigators draw particular attention to biomedical factors but there is growing evidence that biopsychosocial factors appear to be even more important as a basis of an intervention program . Methods We studied the effectiveness of a tailor-made program with respect to biopsychosocial factors ( intervention group ) in women with pregnancy-related pelvic girdle and / or low back pain versus usual care based on a pain contingent basis ( control group ) shortly after delivery in a r and omized controlled trial . Women with severe complaints shortly after delivery were selected from a longitudinal prospect i ve cohort study ( n = 7526 ) , aim ed at pregnancy-related pelvic girdle and /or low back pain in the Netherl and s. A concealed block r and omization was performed after collecting baseline data . Research ers were blinded to treatment assignment . Outcomes were evaluated within the domains of the biopsychosocial approach . Primary outcome concerned limitations in activities ( RDQ ) . Follow-up measurements were performed 12 weeks after delivery . Results Since May 2001 until July 2003 , 869 women out of the cohort made a request for treatment by a physiotherapist , 10 days after delivery . Because of a quick recovery in two weeks time , we included only 126 women three weeks after delivery . There was a statistically significant and clinical ly relevant difference in improvement on the primary outcome ( RDQ ) between the two groups in favor of the experimental intervention . Conclusion The results favored the hypotheses . Women 's worries about their condition were major targets in the experimental intervention . The prognosis after delivery , especially in de first weeks , turned out to be favorable This study was undertaken to investigate the effects of acupuncture in low back and pelvic pain during pregnancy under real life conditions , as compared with patients undergoing conventional treatment alone . A total of 61 conventionally treated pregnant women were allocated r and omly into two groups to be treated or not by acupuncture . Twenty-seven patients formed the study group and 34 the control group . They reported the severity of pain using a Numerical Rating Scale from 0 to 10 , and their capacity to perform general activities , to work , and to walk . We also assessed the use of analgesic drugs . Women were followed up for eight weeks and interviewed five times , at two-week intervals . All women completed the study . In the study group the average pain during the study period showed a larger reduction ( 4.8 points ) than the control group ( −0.3 points ) ( P<0.0001 ) . Average pain scores decreased by at least 50 % over time in 21 ( 78 % ) patients in the acupuncture group and in five ( 15 % ) patients in the control group ( P<0.0001 ) . Maximum pain and pain at the moment of interview were also less in the acupuncture group compared with the control group . The capacity to perform general activities , to work and to walk was improved significantly more in the study group than in the control group ( P<0.05 ) . The use of paracetamol was lower in the acupuncture group ( P<0.01 ) . These results indicate that acupuncture seems to alleviate low back and pelvic pain during
Output:
| RESULTS For lumbopelvic pain during pregnancy , the evidence was strong for positive effects of acupuncture and pelvic belts .
The evidence was low for exercise in general and for specific stabilizing exercises .
The evidence was very limited for efficacy of water gymnastics , progressive muscle relaxation , a specific pelvic tilt exercise , osteopathic manual therapy , craniosacral therapy , electrotherapy and yoga .
For postpartum lumbopelvic pain , the evidence was very limited for clinic-based treatment concepts , including specific stabilizing exercises , and for self-management interventions for women with severe disabilities .
No specific adverse events were reported for any intervention .
The levels of evidence were strong for a positive effect of acupuncture and pelvic belts , but weak for an effect of specific exercises . |
MS213581 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The aim of the present study was to compare the effect of transcutaneous electric nerve stimulation ( TENS ) with the flat occlusal splint in the treatment of temporom and ibular joint ( TMJ ) disk displacement without reduction . Thirty-one patients were included and r and omly selected to be treated 6 weeks with either TENS ( 90 Hz , 30 min , three times/day ) or with a flat occlusal splint ( 24 h/day . Those selected for the TENS group had one electrode placed over the painful TMJ and another electrode over the anterior temporal muscle . The splint group used a conventional flat occlusal splint with cuspid guidance . Both treatment groups visited the clinic once a week . Symptoms and signs were registered before and after treatment . The intensity of pain was recorded with a visual analogue scale ( VAS ) and with an electronic pocket-sized recorder ( Pain-Track ) carried 1 week before and also the last week of treatment for continuous registration of pain . Measured with the VAS , half of the patients treated with splints became pain-free or their TMJ pain improved at least 50 % both at rest and with jaw function compared with only 6 % in the TENS-treated group . With regard to strictly chewing pain , the VAS-registered pain improved in two-thirds of the splint group , compared with 50 % of the TENS group . With the Pain-Track device it was found that in most individuals pain was aggrevated at mealtimes . The conclusion was that flat occlusal splints in several respects are better than TENS in the treatment of symptoms associated with TMJ disk displacement without reduction Masticatory myofascial pain ( MFP ) condition is a musculoskeletal disorder that compromises the functional capacities of the masticatory system . As such , the incorporation of an intensive chewing test as a discriminatory exercise for the diagnosis of this condition and evaluation of treatment success has considerable potential . Various splint design s have been used successfully , which have posed a question of whether the therapeutic effect of the splint is a placebo or has some other curative properties . The purpose of this study was to evaluate the efficacy of the stabilization appliance to reduce signs and symptoms in MFP patients and to compare the pain experience during the chewing test between two groups of patients , with and without splints . Myofascial pain patients ( n = 37 ) who reported exacerbation of pain in function participated in the study . Patients perfomed a 9-min chewing test , followed by 9-min rest and marked their pain intensity on a visual analogue scale every 3 min . Of the 37 patients , 21 received a stabilization flat occlusal splint for night use and 16 were equally monitored clinical ly without a splint . At the end of 8 weeks , a second clinical examination and chewing test were performed . Student 's t-test was used to analyse differences between study groups . Analysis of variance and covariance ( ancova ) with repeated measures was applied to analyse the effect of treatment . Level of pain at baseline prior to the chewing test ( P0 ) was introduced as a co-variant . At baseline both groups showed relatively high scores of pain intensity and did not show any significant differences among the collected variables . At the end of the experiment , the splint group had a statistically significant reduction in pain intensity , in mean muscle sensitivity to palpation and in the pain experience during the chewing test compared with no change in the controls . A stabilization splint has a therapeutic value beyond its placebo effects . Thus , it should be an integral part of the treatment modalities in MFP disorder patients . An intensive chewing test is an effective tool to evaluate the treatment modality efficacy in MFP patients AIMS To compare the short-term efficacy of treatment with a stabilization appliance compared with that of a non-occlusal , control appliance in patients with temporom and ibular disorders ( TMD ) of mainly myogenous origin . METHODS A r and omized , controlled trial was performed with 60 patients suffering from myofascial pain . Patients were r and omly assigned to a treatment or a control group . The treatment group was treated by means of a stabilization appliance and the control group by means of a non-occlusal appliance . Symptoms and signs were registered before and after 10 weeks of treatment . RESULTS Improvement of overall subjective symptoms was reported in both groups , but significantly more often in the treatment group than in the control group ( P = .000 ) . The prevalence of daily or constant pain showed a significant reduction in the treatment group ( P = .028 ) compared with the control group . There was a significant decrease in the number of tender masticatory muscles in the treatment group ( P = .018 ) compared with the control group . CONCLUSION The results of this short-term evaluation suggest that the stabilization appliance is more effective in alleviating symptoms and signs in patients with TMD of mainly myogenous origin than a control , non-occlusal appliance . The stabilization appliance can therefore be recommended for the therapy of these patients Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size In order to evaluate and compare the effects of biofeedback and occlusal splint therapy on m and ibular dysfunction , 30 patients were r and omly divided into two treatment groups . The patients were women aged 20 - -40 years without any obvious organic reasons for their symptoms . There were no significant differences between the two groups before the start of treatment in respect of signs and symptoms of m and ibular dysfunction . One group used full coverage splints at night for 6 weeks . The other group received biofeedback training up to six times , 30 min per session . One month after completion of the therapy the patients were re-examined . Both groups showed a significant reduction in symptoms , both subjectively and clinical ly . No significant differences between the groups were found . The two treatments were thus equally effective in the short-term perspective in patients with signs and symptoms of m and ibular dysfunction Forty-five individuals with long-st and ing facial pain or headache of muscular origin were r and omly allocated into three groups . The first group was treated with acupuncture , the second group received an occlusal splint , and the third group served as controls . Both acupuncture and occlusal splint therapy significantly reduced subjective symptoms and clinical signs from the stomatognathic system . No differences between these two groups were found with regard to treatment effects . It is concluded that acupuncture is an alternative method to conventional stomatognathic treatment for individuals with craniom and ibular disorders of muscular origin Twenty-four patients were selected to participate in this study . Twelve patients were r and omly selected to receive occlusal splint therapy and the other 12 to receive a simplified relaxation therapy technique . Observable pain scores , maximum comfortable interincisal distance , and maximum interincisal distances were recorded for each group before and after treatment . The occlusal splint group showed a significant decrease in total mean observable pain scores ( decrease score of 10.5 , t = 3.124 ; P less than 0.1 ) . The relaxation group showed no significant decrease in total mean observable pain scores ( decrease score of 1.8 , t = 0.888 ; P = ns ) . The occlusal splint group showed a significant increase in the mean maximum comfortable opening ( an increase of 12.4 mm , t = 5.085 ; P less than .01 ) . The relaxation group showed no significant increase in the mean maximum comfortable opening ( an increase of 2.3 mm , t = 0.734 ; P = ns ) . The occlusal splint group showed a significant increase in the mean maximum opening ( an increase of 6.0 mm , t = 2.471 ; P less than .05 ) . The relaxation group showed no increase in the mean maximum opening ( decrease of 0.7 mm , t = 0.343 ; P = ns ) . This study suggests that occlusal splint therapy is a more effective treatment for the pain , tenderness , and limited m and ibular opening associated with temporom and ibular disorders than relaxation therapy . In this study , the relaxation technique used had no significant effect on the patients ' pain , tenderness , or limited opening To assess the differential efficacy of two commonly used treatments for temporom and ibular disorders ( TMD ) , intraoral appliances ( IAs ) and biofeedback ( BF ) , separately and in combination , two studies were conducted . The first study directly compared IA treatment , a combination of biofeedback and stress management ( BF/SM ) , and a waiting list control group in a sample of 80 TMD patients . Both treatments were determined to be equally credible to patients , ruling out this potential threat to the validity of the results obtained . The results demonstrated that the IA treatment was more effective than the BF/SM treatment in reducing pain after treatment , but at a 6-month follow-up the IA group significantly relapsed , especially in depression , whereas the BF/SM maintained improvements on both pain and depression and continued to improve . The second study examined the combination of IA and BF/SM in a sample of 30 TMD patients . The results of this study demonstrated that the combined treatment approach was more effective than either of the single treatments alone , particularly in pain reduction , at the 6-month follow-up . These results support the importance of using both dental and psychologic treatments to successfully treat TMD patients if treatment gains are to be maintained The aim of this study was to investigate if the difference in treatment outcome between patients provided with a stabilisation appliance and a control appliance was due to the treatment and /or other factors in patients with temporom and ibular disorders ( TMD ) of arthrogeneous origin . Sixty patients were assigned to two equally sized groups : a treatment group , treated with a stabilisation appliance , and a control group given a control appliance . Thirteen possible background variables for the treatment outcome were correlated to changes in severity of temporom and ibular joint ( TMJ ) pain on a verbal scale in the two patient groups . The logistic regression analyses revealed that , after correcting for the background variables , stabilisation appliance treatment was a strong explanatory factor for a positive treatment outcome , with a significance of P = 0.0013 compared to patients belonging to the control group . Background variables of significant importance for the treatment outcome were male sex ( positive ) ( P = 0.0268 ) , and severe or very severe TMJ pain ( negative ) ( P = 0.0034 ) . These findings indicate that not only the treatment with a stabilisation appliance but also sex and the intensity of the TMJ pain before treatment might influence the treatment outcome in patients with TMD of arthrogeneous origin One hundred and ten patients , 23 males and 87 females , participated in a comparative study of the effect of acupuncture and occlusal splint therapy . All the patients exhibited signs and symptoms of craniom and ibular disorders ( CMD ) and had had pain for more than six months . The participants were r and omly assigned to three groups ; acupuncture treatment , occlusal splint therapy or control . The patients were evaluated before and immediately after treatment/control time . Ten different subjective and /or clinical assessment variables were used in the evaluation of the treatment effects . Both acupuncture and occlusal splint therapy reduced the symptoms as compared with the control group in which the symptoms remained essentially unchanged . In this short-term study , acupuncture gave better subjective results ( p < 0.001 ) than the occlusal splint therapy In a r and omized trial the effects of occlusal appliance and relaxation therapy , each combined with brief information , were compared with brief information only , in adolescents with temporom and ibular disorder ( TMD ) pain . One-hundred- and -twenty-two adolescents ( 93 F and 29 M aged 12 - 18 years ) were r and omly assigned to one of the following 3 groups : brief information + occlusal appliance ( BI + OA ) , brief information + relaxation therapy ( BI + RT ) , or brief information ( BI ) . Included were subjects reporting pain once a week or more often , in addition to receiving a diagnosis of TMD according to the Research Diagnostic Criteria ( RDC/TMD ) . They were evaluated before and after treatment and at a 6-month follow-up by means of self-reports and clinical assessment . The result revealed a significantly higher reduction in frequency of pain , in pain intensity ( visual analog scale [ VAS ] ) , and in a composite pain index ( intensity x frequency ) for patients treated with BI + OA compared with
Output:
| Based on the currently best available evidence it appears that most patients with masticatory muscle pain are helped by the incorporation of a stabilization splint .
Nevertheless , evidence is equivocal if improvement of pain symptoms after incorporation of the intraoral appliance is caused by a specific effect of the appliance .
A stabilization splint does not appear to yield a better clinical outcome than a soft splint , a non-occluding palatal splint , physical therapy , or body acupuncture . |
MS213582 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background The association between change in weight or body mass index , and mortality is widely reported , however , both measures fail to account for fat distribution . Change in waist circumference , a measure of central adiposity , in relation to mortality has not been studied extensively . Methods We investigated the association between mortality and changes in directly measured waist circumference , hips circumference and weight from baseline ( 1990–1994 ) to wave 2 ( 2003–2007 ) in a prospect i ve cohort study of people aged 40–69 years at baseline . Cox regression , with age as the time metric and follow-up starting at wave 2 , adjusted for confounding variables , was used to estimate hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) for change in body size in relation to mortality from all causes , cardiovascular disease and cancer . Results There were 1465 deaths ( 109 cancer , 242 cardiovascular disease ) identified during an average 7.7 years of follow-up from 21 298 participants . Compared to minimal increase in body size , loss of waist circumference ( HR : 1.26 ; 95 % CI : 1.09–1.47 ) , weight ( 1.80 ; 1.54–2.11 ) , or hips circumference ( 1.35 ; 1.15–1.57 ) were associated with an increased risk of all-cause mortality , particularly for older adults . Weight loss was associated with cardiovascular disease mortality ( 2.40 ; 1.57–3.65 ) but change in body size was not associated with obesity-related cancer mortality . Conclusion This study confirms the association between weight loss and increased mortality from all-causes for older adults . Based on evidence from observational cohort studies , weight stability may be the recommended option for most adults , especially older adults Studies have reported a higher mortality risk associated with weight loss , particularly in middle-aged and older adults , although some of these studies did find that gaining weight was also associated with an increased mortality risk . We examined changes in weight in relation to mortality in a prospect i ve population -based cohort study of men and women , resident in Norfolk , UK . Participants were assessed at baseline ( 1993–1997 ) and at a second examination ( 1998–2000 ) , as part of the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC-Norfolk ) study , and followed up to 2015 for mortality . Participants with a self-reported history of cancer or cardiovascular disease , body mass index < 18.5 kg/m2 or missing data on adjustment variables , at either time-point were excluded , leaving 12,580 participants , aged 39–78 in 1993–1997 , eligible for analyses . Cox proportional hazards models were used to determine Hazard Ratios ( HRs ) for all-cause ( 2603 deaths ) , cardiovascular ( 749 deaths ) , cancer ( 981 deaths ) , respiratory ( 226 deaths ) and other causes of mortality ( 647 deaths ) by categories of weight change . After multivariate adjustment , the HRs ( 95 % CIs ) for all-cause mortality for men and women who lost more than 5 kg were 1.85 ( 1.48–2.31 ) and 1.64 ( 1.31–2.05 ) respectively . Higher hazards were also found for specific causes of mortality and weight loss > 5 kg . Similar associations were observed after excluding deaths in the first 5 years of follow-up . Results for weight gain were inconclusive . We conclude that objective ly measured weight loss , but not weight gain , was associated with subsequent higher mortality risk in this population -based study of middle-aged and elderly men and women . However , undiagnosed , pre-existing disease and the inability to account for weight cycling need to be remembered when interpreting these results . Unravelling the causal pathways underlying this association will require more detailed studies , including that of changes in body composition Although 25 % of US men indicate that they are trying to lose weight , the association between intentional weight loss and longevity in men is unknown . The authors analyzed prospect i ve data from 49,337 overweight ( initial body mass index > or = 27 ) white men aged 40 - 64 years who , in 1959 - 1960 , answered questions on weight change direction , amount , time interval , and intent . Vital status was determined in 1972 . Proportional hazards regression estimated mortality rate ratios for men who intentionally lost weight compared with men with no weight change . Analyses were stratified by health status and adjusted for age , initial body mass index , smoking status , alcohol intake , education , physical activity , health history , and physical symptoms . Among men with no reported health conditions ( n = 36,280 ) , intentional weight loss was not associated with total , cardiovascular ( CVD ) , or cancer mortality , but diabetes-associated mortality was increased 48 % ( 95 % confidence interval ( CI ) -7 % to + 133 % ) among those who lost 20 pounds ( 9.1 kg ) or more ; this increase was largely related to non-CVD mortality . Among men with reported health conditions ( n = 13,057 ) , intentional weight loss had no association with total or CVD mortality , but cancer mortality increased 25 % ( 95 % confidence interval -4 % to + 63 % ) among those who lost 20 pounds or more . Diabetes-associated mortality was reduced 32 % ( 95 % confidence interval -52 % to -5 % ) among those who lost less than 20 pounds and 36 % ( 95 % confidence interval -49 % to -20 % ) among those who lost more than 20 pounds . These results and those from our earlier study in women ( Williamson et al. , Am J Epidemiol 1995;141:1128 - 41 ) suggest that intentional weight loss may reduce the risk of dying from diabetes , but not from CVD . In observational studies , however , it is difficult to separate intentional weight loss from unintentional weight loss due to undiagnosed , underlying disease . Well- design ed observational studies , as well as r and omized controlled trials , are needed to determine whether intentional weight loss reduces CVD mortality OBJECTIVE The prevalence of obesity is increasing in many European countries and in the United States . This report examines the mortality and morbidity associated with being overweight and obese in the Caerphilly Prospect i ve Study and the relative effects of weight in middle age and self reported weight at 18 years . DESIGN All men aged 45 to 59 years from the town of Caerphilly , South Wales and outlying villages were identified and 2512 men were examined for the first time between 1979 and 1983 . Men were asked to recall their weight at 18 years of age ( when the majority had been examined for National Service ) so that weight then , weight at screening , and the difference could be related to their 14 year follow up from screening . A total of 2335 men could recall their weight at 18 years . By 14 years of follow up from screening 465 men had died and 382 had had coronary events . RESULTS Mean body mass index in men who reported their weight at 18 years was 22.3 ( SD 2.8 ) kg/m2 and only 41 of these men ( 1.8 % ) were classified as obese ( index ⩾ 30 kg/m2 ) . The index did not predict all cause mortality when examined by quintile . For major ischaemic heart disease ( non-fatal or fatal ischaemic heart disease ) the relative odds was 1.73 ( 95 % CI 1.21 , 2.48 ) in the top fifth of the distribution ( body mass index ⩾ 24.2 kg/m2 ) compared with the bottom fifth ( body mass index < 20.1 kg/m2 ) . In men with an index ⩾ 30 kg/m2 however , the relative odds were 2.03 ( 95 % CI , 1.03 , 4.01 ) for all cause mortality and 2.17 ( 95 % CI , 1.08 , 4.34 ) for major ischaemic heart disease , adjusted for age , smoking habit and social class . When men were recruited to the study , from 1979 to 1983 ; the mean body mass index had increased to 26.2 ( SD 3.6 ) , a mean increase of 3.9 kg/m2 or 11.2 kg ; 299 men ( 12.1 % ) were classified as obese and showed significantly increased relative odds of both all cause mortality ( 1.53 ( 95 % CI 1.14 , 2.06 ) and major ischaemic heart disease ( 1.55 ( 95 % CI 1.13 , 2.11 ) ) , adjusted for age , smoking habit and social class relative to the non-obese men . The effect of gain in weight from 18 years to recruitment was also examined ; all cause mortality showed highest mortality in the fifth of the distribution who experienced weight loss or minimal weight gain . For major ischaemic heart disease an inconsistent , weak trend was shown , the relative odds rising to a maximum of 1.26 ( 0.89 , 1.80 ) in the top fifth of weight gain compared with the bottom fifth . Weight gain showed strong associations with potential cardiovascular risk factors measured at recruitment ; insulin , triglyceride , glucose , diastolic and systolic blood pressure and high density lipoprotein-cholesterol . CONCLUSIONS Body mass at 18 years of age of 30 kg/m2 or more conferred increased risk for all cause mortality and major ischaemic heart disease during 14 years of follow up of men aged 45 to 59 years . By the baseline examination the prevalence of obesity ( body mass index ⩾30 ) had increased from 1.8 % to 12.1 % ; obese men also showed an excess risk of major ischaemic heart disease and overall mortality , but these risks were lower than those predicted from 18 years of age . Weight gain was strongly associated with smoking habit , the greatest weight gain being among ex-smokers and the least among light smokers . Weight gain from 18 years of age to baseline examination showed little relation with subsequent mortality and risk of major ischaemic heart disease when adjusted for age , smoking habit and social class . The lowest mortality rate occurred in the “ fifth ” of men who gained a mean weight of 16.1 kg . Weight gain is closely associated with some adverse cardiovascular risk factors ; in particular with insulin , triglyceride , glucose and diastolic blood pressure OBJECTIVE --To assess the validity of the 1990 US weight guidelines for women that support a substantial gain in weight at approximately 35 years of age and recommend a range of body mass index ( BMI ) ( defined as weight in kilograms divided by the square of height in meters ) from 21 to 27 kg/m2 , in terms of coronary heart disease ( CHD ) risk in women . DESIGN -- Prospect i ve cohort study . SETTING --Female registered nurses in the United States . PARTICIPANTS --A total of 115,818 women aged 30 to 55 years in 1976 and without a history of previous CHD . MAIN OUTCOME MEASURE -- Incidence of CHD defined as nonfatal myocardial infa rct ion or fatal CHD . RESULTS --During 14 years of follow-up , 1292 cases of CHD were ascertained . After controlling for age , smoking , menopausal status , postmenopausal hormone use , and parental history of CHD and using as a reference women with a BMI of less than 21 kg/m2 , relative risks ( RRs ) and 95 % confidence intervals ( CIs ) for CHD were 1.19 ( 0.97 to 1.44 ) for a BMI of 21 to 22.9 kg/m2 , 1.46 ( 1.20 to 1.77 ) for a BMI of 23 to 24.9 kg/m2 , 2.06 ( 1.72 to 2.48 ) for a BMI of 25 to 28.9 kg/m2 , and 3.56 ( 2.96 to 4.29 ) for a BMI of 29 kg/m2 or more . Women who gained weight from 18 years of age were compared with those with stable weight ( + /- 5 kg ) in analyses that controlled for the same variables as well as BMI at 18 years of age . The RRs and CIs were 1.25 ( 1.01 to 1.55 ) for a 5- to 7.9-kg gain , 1.64 ( 1.33 to 2.04 ) for an 8- to 10.9-kg gain , 1.92 ( 1.61 to 2.29 ) for an 11- to 19-kg gain , and 2.65 ( 2.17 to 3.22 ) for a gain of 20 kg or more . Among women with the BMI range of 18 to 25 kg/m2 , weight gain after 18 years of age remained a strong predictor of CHD risk . CONCLUSIONS --Higher levels of body weight within the " normal " range , as well as modest weight gains after 18 years of age , appear to increase risks of CHD in middle-aged women . These data provide evidence that current US weight guidelines may be falsely reassuring to the large proportion of women older than 35 years who are within the current guidelines but have potentially
Output:
| Adult weight gain may be associated with a higher risk of CVD .
Measuring weight gain during adulthood may be better than static , cross-sectional assessment of weight because it considers trend over time , and thus , can be used as a supplementary approach to predict CVD |
MS213583 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To evaluate the effect of the middle and junior high school Drug Abuse Resistance Education ( D.A.R.E. ) and D.A.R.E. Plus programs on drug use and violence . DESIGN R and omized controlled trial of 24 schools , with 3 conditions : D.A.R.E. only , D.A.R.E. Plus , and delayed program control . SETTING Schools and neighborhoods , primarily in Minneapolis-St Paul . PARTICIPANTS All seventh- grade students in 24 schools in the academic year 1999 - 2000 ( N = 6237 at baseline , 67.3 % were white , and there was 84.0 % retention at final follow-up ) . INTERVENTIONS The middle and junior high school D.A.R.E. curriculum in the 16 schools that received D.A.R.E. only and D.A.R.E. Plus . In the 8 schoolts that received D.A.R.E. Plus , additional components included a peer-led parental involvement classroom program called " On the VERGE , " youth-led extracurricular activities , community adult action teams , and postcard mailings to parents . The interventions were implemented during 2 school years , when the cohort was in the seventh and eighth grade s. MAIN OUTCOME MEASURES Self-reported tobacco , alcohol , and marijuana use ; multidrug use ; violence ; and victimization , assessed at the beginning and end of seventh grade and at the end of eighth grade . Growth curve analytic methods were used to assess changes over time by condition . RESULTS There were no significant differences between D.A.R.E. only and the controls ; significant differences among boys between D.A.R.E. Plus and controls for tobacco , alcohol , and multidrug use and victimization ; significant differences among boys between D.A.R.E. Plus and D.A.R.E. only in tobacco use and violence ; and no significant behavioral differences among girls . CONCLUSION D.A.R.E. Plus significantly enhanced the effectiveness of the D.A.R.E. curriculum among boys and was more effective than the delayed program controls , underscoring the potential for multiyear , multicomponent prevention programs and demonstrating sex differences in response to intervention programs This article review s major risk factors for cigarette smoking , alcohol , and other drug abuse and promising community-based approaches to primary prevention . In a longitudinal experimental study , 8 representative Kansas City communities were assigned r and omly to program ( school , parent , mass media , and community organization ) and control ( mass media and community organization only ) conditions . Programs were delivered at either 6th or 7th grade , and panels were followed through Grade 9 or 10 . The primary findings were ( a ) significant reductions at 3 years in tobacco and marijuana use and ( b ) equivalent reductions for youth at different levels of risk . This study provides evidence that a comprehensive community program-based approach can prevent the onset of substance abuse and that the benefits are experienced equally by youth at high and low risk Abstract Preparing for the Drug-Free Years ( PDFY ) is a curriculum design ed to help parents learn skills to consistently communicate clear norms against adolescent substance use , effectively and proactively manage their families , reduce family conflict , and help their children learn skills to resist antisocial peer influences . This study examined the effects of PDFY on the trajectories of these factors , as well as on the trajectory of alcohol use from early to mid adolescence . The sample consisted of 424 rural families of sixth grade rs from schools r and omly assigned to an intervention or a control condition . Data were collected from both parents and students at pretest , posttest , and 1- , 2- and 3 $ $ \frac{1}{2}$$ -year follow-ups . Latent growth models were examined . PDFY significantly reduced the growth of alcohol use and improved parent norms regarding adolescent alcohol use over time . Implication s for prevention and evaluation are discussed OBJECTIVE To examine the long-term effects of an intervention combining teacher training , parent education , and social competence training for children during the elementary grade s on adolescent health-risk behaviors at age 18 years . DESIGN Nonr and omized controlled trial with follow-up 6 years after intervention . SETTING Public elementary schools serving high-crime areas in Seattle , Wash. PARTICIPANTS Of the fifth- grade students enrolled in participating schools , 643 ( 76 % ) were given written parental consent for the longitudinal study and 598 ( 93 % ) were followed up and interviewed at age 18 years . INTERVENTIONS A full intervention provided in grade s 1 through 6 of 5 days of in-service training for teachers each intervention year , developmentally appropriate parenting classes offered to parents when children were in grade s 1 through 3 and 5 through 6 , and developmentally adjusted social competence training for children in grade s 1 and 6 . A late intervention , provided in grade s 5 and 6 only , paralleled the full intervention at these grade s. MAIN OUTCOME MEASURES Self-reported violent and nonviolent crime , substance use , sexual activity , pregnancy , bonding to school , school achievement , grade repetition and school dropout , suspension and /or expulsion , and school misbehavior ; delinquency charges from court records ; grade point average ; California Achievement Test scores : and disciplinary action reports from school records . RESULTS Fewer students receiving full intervention than control students reported violent delinquent acts ( 48.3 % vs 59.7 % ; P=.04 ) , heavy drinking ( 15.4 % vs 25.6 % ; P=.04 ) , sexual intercourse ( 72.1 % vs 83.0 % ; P=.02 ) , having multiple sex partners ( 49.7 % vs 61.5 % ; P=.04 ) , and pregnancy or causing pregnancy ( 17.1 % vs 26.4 % ; P=.06 ) by age 18 years . The full intervention student group reported more commitment ( P=.03 ) and attachment ( P=.006 ) to school , better academic achievement ( P=.01 ) , and less school misbehavior ( P=.02 ) than control students . Late intervention in grade s 5 and 6 only did not significantly affect health-risk behaviors in adolescence . CONCLUSIONS A package of interventions with teachers , parents , and children provided throughout the elementary grade s can have enduring effects in reducing violent behavior , heavy drinking , and sexual intercourse by age 18 years among multiethnic urban children . Results are consistent with the theoretical model guiding the intervention and support efforts to reduce health-risk behaviors through universal interventions in selected communities or schools serving high-crime neighborhoods In this article , we examine the impact of two universal , grade 1 preventive interventions on the onset of tobacco smoking as assessed in early adolescence . The classroom-centered ( CC ) intervention was design ed to reduce the risk for tobacco smoking by enhancing teachers ' behavior management skills in first grade and , thereby , reducing child attention problems and aggressive and shy behavior-known risk behaviors for later substance use . The family-school partnership ( FSP ) intervention targeted these early risk behaviors via improvements in parent-teacher communication and parents ' child behavior management strategies . A cohort of 678 urban , predominately African-American , public school students were r and omly assigned to one of three Grade 1 classrooms at entrance to primary school ( age 6 ) . One classroom featured the CC intervention , a second the FSP intervention , and the third served as a control classroom . Six years later , 81 % of the students completed audio computer-assisted self-interviews . Relative to controls , a modest attenuation in the risk of smoking initiation was found for students who had been assigned to either the CC or FSP intervention classrooms ( 26 % versus 33 % ) ( adjusted relative risk for CC/control contrast=0.57 , 95 % confidence interval ( CI ) , 0.34 - 0.96 ; adjusted relative risk for FSP/control contrast=0.69 , 95 % CI , 0.50 - 0.97 ) . Results lend support to targeting the early antecedent risk behaviors for tobacco smoking This study evaluated the substance initiation effects of an intervention combining family and school-based competency-training intervention components . Thirty-six rural schools were r and omly assigned to 1 of 3 conditions : ( a ) the classroom-based Life Skills Training ( LST ) and the Strengthening Families Program : For Parents and Children 10 - 14 , ( b ) LST only , or ( c ) a control condition . Outcomes were examined 1 year after the intervention posttest , using a substance initiation index ( SII ) measuring lifetime use of alcohol , cigarettes , and marijuana and by rates of each individual substance . Planned intervention-control contrasts showed significant effects for both the combined and LST-only interventions on the SII and on marijuana initiation . Relative reduction rates for alcohol initiation were 30.0 % for the combined intervention and 4.1 % for LST only Project Northl and was a r and omized trial to reduce alcohol use among adolescents in 24 school districts in northeastern Minnesota . Phase 1 ( 1991 - 1994 ) , when the targeted cohort was in grade s 6 - 8 , included school curricula , parent involvement , peer leadership and community task forces . The Interim Phase ( 1994 - 1996 ) involved minimal intervention . Phase 2 ( 1996 - 1998 ) , when the cohort was in grade s 11 and 12 , included a classroom curriculum , parent education , print media , youth development and community organizing . Outcomes of these interventions were assessed by annual student surveys from 1991 to 1998 , alcohol purchase attempts by young-looking buyers in 1991 , 1994 and 1998 , and parent telephone surveys in 1996 and 1998 . Growth curve analysis was used to examine the student survey data over time . Project Northl and was most successful when the students were young adolescents . The lack of intervention in the Interim Phase when the students were in grade s 9 and 10 had a significant and negative impact on alcohol use . The intervention used with the high school students as those in grade s 11 and 12 made a positive impact on their tendency to use alcohol use , binge drinking and ability to obtain alcohol . There was no impact in Phase 2 on other student-level behavioral and psychosocial factors . Developmentally appropriate , multi-component , community-wide programs throughout adolescence appear to be needed to reduce alcohol use In autumn 1995 The Norwegian Cancer Society in cooperation with The Research Center for Health Promotion , University of Bergen started a study of school-based interventions aim ing at preventing smoking among pupils in Norwegian secondary schools . The study comprised a nationwide sample of 4441 students at 99 schools ( 195 classes ) . This panel of students is followed through annual data collection s till they graduate in spring 1997 . Written consensus from students and parents was obtained from 95 % . Schools were systematic ally allocated to one of four groups : Group A , control ; Group B , intervention , containing classroom program , involvement of parents and teacher courses ; Group C , like B , but without teacher courses ; Group D , like B , but without parental involvement . Baseline data were collected by question naires administered in class in November 1994 and the first follow-up survey was carried out in May 1995 . At follow-up the proportion of smokers had increased by 8.3 percentage points in Group A ( control ) and by 1.9 percentage points in Group B ( most extensive intervention ) . As expected , the recruitment of smokers was higher in Groups C and D than in the ideal intervention , but lower than in the control group . Effects of the most extensive program among subgroups of students were examined by comparing Groups A and B. Students are categorized as high risk or low risk based on scores on scales measuring sensation seeking , physical maturity , antisocial behavior and parental smoking . The effect of the program on recruitment of smokers seems to have been at least as strong or even stronger among ' high-risk ' students than among other students Objective : To evaluate Smoke-free Kids , a new home based programme to assist parents who smoke in socialising their children against smoking . Design : Two year r and omised controlled trial . Participants : At baseline , 887 adult smokers who had an abstinent child in the third grade ( ages 7–8 years ) ; 671 adults and children were retained through the 24 month follow up . Intervention : Programme modules , newsletters , incentives , support calls . Outcomes : Anti-smoking socialisation ; susceptibility to smoking . Results : Of 327 parents r and omised to treatment , 210 obtained adequate treatment by using at least three of five core modules . Programme efficacy analyses , which compared these parents with controls ( n = 344 ) , showed that exposure to adequate treatment predicted significantly higher levels in nearly all categories of anti-smoking socialisation three months post-intervention . Two years post-baseline , children of parents who reported adequate treatment scored significantly higher than controls on attributes that reduce susceptibility to smoking , and they scored significantly lower than controls on attributes that raise susceptibility to smoking . Programme effectiveness analyses compared all parents r and omised to treatment ( n = 327 ) with controls ( n = 344 ) . Treatment effects were evident for several socialisation outcomes ; however , these effects were smaller and less consistent than those from the efficacy analyses . Similarly , although treated children scored higher than controls on attributes that reduce susceptibility and lower than controls on attributes that raise susceptibility , several of these between-group differences were not significant . Conclusions : Given adequate exposure to the Smoke-free Kids programme , significant beneficial effects were observed on anti-smoking socialisation in households where parents smoke cigarettes , and significant beneficial effects were observed on children ’s susceptibility to smoking after two years . Improving programme acceptance and utilisation is necessary before programme effect
Output:
| We concluded that parenting programmes can be effective in reducing or preventing substance use .
The most effective appeared to be those that shared an emphasis on active parental involvement and on developing skills in social competence , self-regulation and parenting . |
MS213584 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Taenia solium neurocysticercosis ( NCC ) has been documented as one of the major causes of epilepsy in developing countries . However , method ological limitations have hindered the evaluation of the epidemiological relationship between cysticercosis and epilepsy at the community level . METHODS We used the WHO protocol for epidemiological evaluation of neurological disorders to conduct a door-to-door survey among 2723 residents of San Pablo del Lago , an Ecuadorean rural community in which T. solium taeniasis/cysticercosis was known to be endemic . The WHO protocol was complemented by neuroimaging and immunological tests to confirm the diagnosis of this infection . RESULTS In all 31 people suffering from active epilepsy were detected ( prevalence 11.4 per 1000 , 95 % CI:7.7 - 15.4 ) ; 26 agreed to undergo a computer tomography ( CT ) examination , and 28 agreed to have blood drawn for serodiagnosis . Fourteen of the 26 ( 53.8 % ) had CT changes compatible with NCC and six of the 28 ( 21.4 % ) tested positive in the enzyme-linked immunoelectro-transfer blot ( EITB ) assay . In a seizure-free r and om sample of this population , 17 of 118 ( 144 per 1000 ) subjects examined by CT and 10 out of 96 ( 104 per 1000 ) examined by EITB had evidence of this infection . The differences between the epilepsy group and the r and om sample of the population were statistically significant ( OR = 6.93 , 95 % CI : 2.7 - 17.5 , P < 0.001 ) for CT diagnosis , but not for EITB results ( OR = 2.75 , 95 % CI : 0.8 - 7.1 , P > 0.12 , NS ) . CONCLUSIONS These findings confirm that T. solium NCC is a significant cause of epilepsy at the community level in And ean villages of Ecuador . It is important to initiate effective public health interventions to eliminate this infection , which may be responsible for at least half of the cases of reported epilepsy in Ecuador OBJECTIVE Neurologic diseases such as stroke are risk factors for new-onset epilepsy in older adults . Recent evidence suggests that psychiatric disorders independently predict epilepsy in older male veterans . Our aim was to examine the relationship between these disorders in a population -based study of older adults that also included women and minorities . METHODS We used a national 5 % r and om sample of 2005 Medicare beneficiaries including all 50 US states and Washington , DC . Beneficiaries were 65 years of age or older , with continuous Medicare Part A and Part B coverage and not in managed care plans . Epilepsy cases were identified from cl aims for physician visits , hospitalizations , and outpatient procedures . We used logistic regressions for the overall sample and stratified by gender to determine whether risk of new-onset epilepsy was associated with prior history of psychiatric ( i.e. , depression , psychosis , bipolar disorder , schizophrenia , posttraumatic stress disorder ( PTSD ) , adjustment disorder , and substance abuse/dependence ) and neurologic conditions ( i.e. , cerebrovascular disease , dementia , traumatic brain injury , brain tumor , metastatic cancer ) . RESULTS Preexisting psychiatric disorders were significantly associated with new-onset epilepsy in the study population as were the neurologic conditions evaluated . Five of the seven psychiatric disorders examined were independently associated with new-onset epilepsy ; substance abuse , psychosis , bipolar disorder , schizophrenia , and depression . Gender interaction effects were found for substance abuse/dependence and brain tumors . SIGNIFICANCE Both neurologic and psychiatric factors significantly predicted new-onset epilepsy in a population -based sample of male and female older adults . These results support earlier findings and extend the underst and ing of risk models for new-onset epilepsy in broader older adult population Summary Background The prevalence of epilepsy in sub-Saharan Africa seems to be higher than in other parts of the world , but estimates vary substantially for unknown reasons . We assessed the prevalence and risk factors of active convulsive epilepsy across five centres in this region . Methods We did large population -based cross-sectional and case-control studies in five Health and Demographic Surveillance System centres : Kilifi , Kenya ( Dec 3 , 2007–July 31 , 2008 ) ; Agincourt , South Africa ( Aug 4 , 2008–Feb 27 , 2009 ) ; Iganga-Mayuge , Ug and a ( Feb 2 , 2009–Oct 30 , 2009 ) ; Ifakara , Tanzania ( May 4 , 2009–Dec 31 , 2009 ) ; and Kintampo , Ghana ( Aug 2 , 2010–April 29 , 2011 ) . We used a three-stage screening process to identify people with active convulsive epilepsy . Prevalence was estimated as the ratio of confirmed cases to the population screened and was adjusted for sensitivity and attrition between stages . For each case , an age-matched control individual was r and omly selected from the relevant centre 's census data base . Fieldworkers masked to the status of the person they were interviewing administered question naires to individuals with active convulsive epilepsy and control individuals to assess sociodemographic variables and historical risk factors ( perinatal events , head injuries , and diet ) . Blood sample s were taken from a r and omly selected subgroup of 300 participants with epilepsy and 300 control individuals from each centre and were screened for antibodies to Toxocara canis , Toxoplasma gondii , Onchocerca volvulus , Plasmodium falciparum , Taenia solium , and HIV . We estimated odds ratios ( ORs ) with logistic regression , adjusted for age , sex , education , employment , and marital status . Results 586 607 residents in the study areas were screened in stage one , of whom 1711 were diagnosed as having active convulsive epilepsy . Prevalence adjusted for attrition and sensitivity varied between sites : 7·8 per 1000 people ( 95 % CI 7·5–8·2 ) in Kilifi , 7·0 ( 6·2–7·4 ) in Agincourt , 10·3 ( 9·5–11·1 ) in Iganga-Mayuge , 14·8 ( 13·8–15·4 ) in Ifakara , and 10·1 ( 9·5–10·7 ) in Kintampo . The 1711 individuals with the disorder and 2032 control individuals were given question naires . In children ( aged < 18 years ) , the greatest relative increases in prevalence were associated with difficulties feeding , crying , or breathing after birth ( OR 10·23 , 95 % CI 5·85–17·88 ; p<0·0001 ) ; abnormal antenatal periods ( 2·15 , 1·53–3·02 ; p<0·0001 ) ; and head injury ( 1·97 , 1·28–3·03 ; p=0·002 ) . In adults ( aged ≥18 years ) , the disorder was significantly associated with admission to hospital with malaria or fever ( 2·28 , 1·06–4·92 ; p=0·036 ) , exposure to T canis ( 1·74 , 1·27–2·40 ; p=0·0006 ) , exposure to T gondii ( 1·39 , 1·05–1·84 ; p=0·021 ) , and exposure to O volvulus ( 2·23 , 1·56–3·19 ; p<0·0001 ) . Hypertension ( 2·13 , 1·08–4·20 ; p=0·029 ) and exposure to T solium ( 7·03 , 2·06–24·00 ; p=0·002 ) were risk factors for adult-onset disease . Interpretation The prevalence of active convulsive epilepsy varies in sub-Saharan Africa and that the variation is probably a result of differences in risk factors . Programmes to control parasitic diseases and interventions to improve antenatal and perinatal care could substantially reduce the prevalence of epilepsy in this region . Funding Wellcome Trust , University of the Witwatersr and , and South African Medical Research Council OBJECTIVE To determine age-specific incidence and cumulative incidence of epilepsy in a well-defined cohort of elderly people , and to examine how rates of epilepsy are modified by sex , race , stroke , dementia , head injury , and depression . METHODS The authors examined data from a reconstructed cohort based on 1919 community-dwelling volunteers , followed as part of a large ongoing prospect i ve aging study . RESULTS Age-specific incidence was 10.6 ( per 100,000 person-years ) between ages 45 and 59 , 25.8 between ages 60 and 74 , and 101.1 between ages 75 and 89 . Cumulative incidence was 0.15 % from age 45 to age 60 , 0.38 % to age 70 , 1.01 % to age 80 , and 1.47 % to age 90 . In addition , the difference in cumulative incidence among African-American subjects approached statistical significance ( 57.6/100,000 person-years versus 26.1 in Caucasian , p=0.10 ) , and the difference in incidence among subjects reporting a history of stroke was significantly elevated ( p=0.029 ) . Incidence of epilepsy was not statistically elevated among males , those with dementia , or individuals reporting a history of head injury or treatment for depression . Among " healthy " subjects without history of stroke , head injury , or dementia , we observed a cumulative risk of epilepsy with onset after age 60 of only 1.1 % . CONCLUSIONS The incidence of epilepsy was low in this relatively healthy cohort of elderly people , especially among subjects without known risk factors . In this study we identified African-American race as a risk factor in the elderly for epilepsy independent of stroke BACKGROUND The aim of the study was to estimate the prevalence of different types of epilepsy and their possible risk factors in the region of the Assiut Governorate/Egypt . MATERIAL AND METHODS A community based study with r and om sampling of 7 districts , involving 6498 inhabitants . Out of this sample , 578 dropped out leaving 3066 males ( 51.8 % ) and 2854 females ( 48.2 % ) . There were 3660 ( 61.8 % ) urban residents and 2260 ( 38.2 % ) from the rural community . Patients were evaluated using a screening question naire for epilepsy , and then referred to the hospital to be re-evaluated by a qualified neurologist and with electroencephalography ( EEG ) and computed tomography of the brain ( CT ) . RESULTS Seventy-five cases were diagnosed with epilepsy giving an overall the crude lifetime prevalence rate ( CPR ) for epilepsy of 12.67/1000 ( 95 % CI : 9.8 - 15.54 ) . The active prevalence rate was 9.3/1000 and the incidence rate was 1.5/1000 ( 95 % confidence interval : 0.53 - 2.51 ) . Fifty-six cases ( 75 % ) had idiopathic epilepsy ( CPR 9.5/1000 ) . Symptomatic epilepsy was recorded in 19 ( 25 % ) cases ( CPR 3.2/1000 ) . Generalized seizures were more common ( CPR 6.75/1000 ) than partial seizures ( CPR 2.5/1000 ) . The prevalence rate of partial seizures evolving to secondary generalization was 0.84/1000 while simple partial and complex partial seizures had CPR 1.4/1000 and 0.34/1000 , respectively . The CPR of mixed seizures was 0.17/1000 . Epilepsy was slightly but not significantly more common among males than females ( CPR of 14.4 and 10.9 per 1000 population , respectively ) . The CPR was higher in rural than urban population s ( 17.7/1000 , with 95 % CI 12.2 - 23.18 and 9.56/1000 , with 95 % CI : 6.39 - 12.7 , respectively ) and in the illiterate group than the literate population ( 12.02/1000 and 9.94/1000 , respectively ) . The highest prevalence rate was recorded in the early and late childhood period ( 69.78/100,000 and 43.78/100,000 , respectively ) . Prenatal insults and infection represented major causes of symptomatic epilepsy . CONCLUSIONS We found a high prevalence rate of epilepsy ( comparable with that in other Arabic and European countries ) in our community particularly among children and teenagers . Overall
Output:
| A large proportion of the overall public health burden of epilepsy is attributable to preventable causes . |
MS213585 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Acne treatments using laser and light devices have been reported to have varying degrees of efficacy . However , there has been no study of treatment of acne using a dual mode ( quasi-long pulse and Q-switched mode ) 1064-nm Nd : YAG laser assisted with a topically applied carbon suspension . OBJECTIVE To evaluate the clinical efficacy , safety , and histological changes of new laser treatment method for acne vulgaris . METHODS Twenty-two patients received 3 sessions of quasi-long pulse and Q-switched Nd : YAG laser treatment assisted with a topically applied carbon suspension at 2-week intervals in a r and omized split face manner . RESULTS At the final visit , the inflammatory acne lesions were reduced on the laser-treated side by 58.6 % ( P < .001 ) , but increased on the untreated side by 5 % . The noninflammatory acne lesions were reduced on the laser-treated side by 52.4 % ( P < .001 ) . Sebum output reduction , inflammatory cell and cytokine reductions , a decrease of the thickness of a perifollicular stratum corneum and a full epithelium , and skin rejuvenation effect were found . The histopathologic examination of the acne lesions showed decreased inflammation and immunostaining intensity for interleukin 8 , matrix metalloproteinase-9 , toll-like receptor-2 , and nuclear factor kappa B , and tumor necrosis factor alpha was reduced significantly . No severe adverse reactions were reported . All patients reported mild transient erythema that disappeared in a few hours . LIMITATIONS The number of subjects studied was small . CONCLUSIONS This laser treatment was rapid and effective for treating not only the inflammatory but also the noninflammatory acne lesions when compared with the control side . The histopathologic findings correlated well with the clinical acne grade and treatment response . This novel laser treatment appears to be safe and effective for acne treatment Background / Purpose : Acne vulgaris is a very prevalent skin disorder and remains a main problem in practice . Recently , phototherapy with various light spectrums for acne has been used . There are some evidence s that low-level laser therapy ( LLLT ) has beneficial effect in the treatment of acne lesions . In this study , two different wavelengths of LLLT ( 630 and 890 nm ) were evaluated in treatment of acne vulgaris . Material s and Methods : This study was a single-blind r and omized clinical trial . Patients with mild to moderate acne vulgaris and age above 18 years and included were treated with red LLLT ( 630 nm ) and infrared LLLT ( 890 nm ) on the right and left sides of the face respectively , twice in a week for 12 sessions , and clinical ly assessed at baseline and weeks 2 , 4 , 6 , and 8 . Results : Twenty-eight patients were participated in this study . Ten weeks after treatment acne lesion were significantly decreased in the side treated by 630 nm LLLT ( 27.7±12.7 to 6.3±1.9 ) ( P<0.001 ) , but this decrease was not significant in the site treated by 890 nm LLLT ( 26.9±12.4 to 22.2±8.5 ) ( P>0.05 ) . Conclusion : Red wavelength is safe and effective to be used to treat acne vulgaris by LLLT compared to infrared wavelength BACKGROUND Acne patients who fail to respond to conventional treatments have been treated with isotretinoin , an effective treatment coming under strict regulation due to the risk of significant side effects . Photodynamic therapy ( PDT ) may be a viable alternative treatment for recalcitrant acne of various types and levels of severity . OBJECTIVE To determine the safety and efficacy of combination PDT with topical 5-aminolevulinic acid ( ALA ) and activation by long-pulsed , pulsed dye laser ( LP PDL , 595 nm ) energy with topical therapy in patients with mild to severe acne . METHODS A prospect i ve , controlled pilot , proof-of-principle study of 19 consecutive patients ( aged 16 - 47 years , Fitzpatrick skin types I-VI ) with mild to severe cystic , inflammatory , or comedonal acne of the face was conducted . All patients had failed conventional therapy , including oral antibiotics , topical treatments , hormonal therapy , laser procedures ( without ALA ) , and /or oral isotretinoin . Fifteen patients were treated with ALA PDT and 4 patients served as controls ; all were continued on topical medications . Patients undergoing PDT were initially r and omized to receive either blue light or laser energy . Because recrudescence occurred in 1 patient while undergoing multiple treatments with ALA and blue light , all subsequent patients were treated with ALA and laser energy . The total number of patients treated with LP PDL-mediated ALA PDT was 14 . ALA was applied for a short 45-minute incubation followed by 1 minimally overlapping pass with the LP PDL ( 595 nm , 7.0 - 7.5 J/cm2 fluence , 10-ms pulse duration , 10-mm spot size , and dynamic cooling spray of 30 ms with a 30-ms delay ) . Patients treated with conventional therapy ( oral antibiotics , oral contraceptives , and topical medications ) or laser energy without ALA PDT served as control groups . Patients were followed monthly for up to 13 months . RESULTS Complete clearance was achieved in 100 % ( 14 out of 14 ) patients in the LP PDL PDT-treated group . A mean of 2.9 treatments ( range 1 - 6 ; 2.0 - 3.7 , 95 % CI ; n=14 ) was required to achieve complete clearance for a mean follow-up time of 6.4 months ( range 1 - 13 ; 3.8 - 8.9 95 % CI ; n=14 ) . The patient mean percent lesional clearance rate per treatment was 77 % ( 64%-90 % , 95 % CI ; n=14 ) . Improvement in acne lesions became apparent within 1 to 2 weeks after the first treatment . Clearance in the LP PDL PDT group was superior to control groups . In the LP PDL-only control group ( n=2 ) , the patient mean percent lesional clearance rate per treatment was 32 % without complete clearance after 3 to 4 treatments . In the oral antibiotics , oral contraceptives , and topicals control group ( n=2 ) , the clearance rate per treatment was 20 % , the mean clearance rate per month was 4 % , and complete clearance was not achieved after 6 to 10 months . In the LP PDL-mediated PDT group , treatments were well-tolerated with minimal erythema lasting 1 to 2 days . No cases of crusting , blistering , purpura , scarring , or dyspigmentation occurred . A reduction in the erythema in erythematous acne scars was observed . CONCLUSION For teenage to adult patients with recalcitrant comedonal , inflammatory , or cystic acne of various degrees of severity , ALA PDT with activation by LP PDL appears to be a safe and effective treatment with minimal side effects . LP PDL-mediated PDT may serve as an important alternative to isotretinoin . Cosmetically well-accepted , LP PDL PDT combined with topical therapy is the first PDT modality to achieve complete clearance with long-term follow-up as compared to controls BACKGROUND It has been suggested that cystic acne is rare in women 15 to 44 years of age and infrequent in men . OBJECTIVE To determine the prevalence of acne , we analyzed the primary data from the National Health and Nutrition Examination Survey ( NHANES ) that included a cutaneous examination of a stratified r and om sample of 20,749 noninstitutionalized U.S. residents . METHODS We calculated the prevalence of various disease states based on NHANES primary data and the NHANES population weights . Prevalence estimates and male/female ratios of these estimates were calculated . RESULTS From 1971 to 1974 , the projected prevalence of acne conglobata ( grade IV acne ) for women and men 15 to 44 years of age in the United States was 250,000 and 570,000 , respectively . At the time of examination , an additional 582,000 women and 749,000 men were projected to have moderate acne with cysts and scars . Therefore the prevalence of acne conglobata and acne of at least a moderate degree with cysts and scars was 832,000 for women and 1,319,000 for men 15 to 44 years of age . The male/female ratio for acne with cysts and scars is approximately 1.6:1 . CONCLUSION The NHANES examination data demonstrate that acne with cysts and scars is common in both men and women BACKGROUND Long-pulsed dye laser (LPDL)-assisted photodynamic therapy has been suggested to be superior to laser alone for acne vulgaris but no evidence is available . OBJECTIVE To evaluate the efficacy and safety of LPDL alone versus LPDL in photodynamic therapy with methylaminolevulinic acid ( MAL-LPDL ) for acne vulgaris . METHODS Fifteen patients received a series of 3 full-face LPDL treatments and half-face prelaser MAL treatments ; the latter being r and omly assigned to the left or right side . RESULTS Inflammatory lesions were reduced more on MAL-LPDL-treated than on LPDL-treated sides ( week 4 : 70 % vs 50 % , P = .003 ; week 12 : 80 % vs 67 % , P = .004 ) . Noninflammatory lesions reduced similarly . Patient satisfaction was slightly greater with MAL-LPDL versus LPDL treatments ( scale 0 - 10 : week 4 : 7 vs 6 , P = .034 ; week 12 : 8 vs 7.5 , P = .034 ) . Fluorescence measurements detected photobleaching with MAL-LPDL ( 35.3 % ) and LPDL ( 7.3 % ) treatments ( P < .001 ) . Erythema , edema , and pustular eruptions intensified from MAL incubation . No patients experienced pigment changes or scarring . LIMITATIONS The sample size was limited . The split-face design in this r and omized controlled trial does not allow us to draw conclusions about the efficacy of the LPDL , only about the efficacy of MAL-LPDL compared with LPDL alone . CONCLUSIONS MAL-LPDL is slightly superior to LPDL for the treatment of inflammatory acne Abstract Introduction : The aim was to compare the treatment effectiveness of intense pulsed light ( IPL ) and vacuum versus IPL with placebo for mild to moderate comedonal and inflammatory acne . Patients and methods : We r and omized 180 patients with mild to moderate comedonal and inflammatory acne into three groups : Group A – 60 patients treated with vacuum and IPL , Group V – 60 patients treated with IPL , and Group 0 ( control group ) – 60 patients who received topical treatment with Sebium H2O Micellaire Solution . We evaluated the results using the Leeds revised acne-grading system and Cardiff Acne Disability Index . Results : There was a significant reduction in the number of papules , pustules , and comedones in Groups A and V compared with those in the control group ( p < 0.001 ) with a more rapid decrease of the papules from Group A compared with that from Group V. We found an improvement in the clinical aspect ( p < 0.001 ) when we compared Groups A and V with controls . Patients belonging to Group A were more satisfied compared with those belonging to Group V ( p = 0.004 ) and significantly more satisfied compared with those belonging to Group 0 ( p < 0.001 ) . In conclusion , we consider that both the devices are efficient , the combination of vacuum and IPL representing a therapeutic option for the comedonal acne BACKGROUND Various forms of laser therapy including the pulsed-dye laser ( PDL ) have been reported to reduce acne lesion counts . OBJECTIVE In this study , the benefits and complications when using a 595-nm PDL for the treatment of acne vulgaris were evaluated when comparing a subpurpuric ( low ) fluence level with a purpuric ( high ) fluence level . MATERIAL S AND METHODS This study was a prospect i ve , single-blinded split-face clinical trial . Inclusion criteria included subjects with moderate to severe facial acne . All participants were treated with PDL , with each half of the face receiving either high or low fluence at 3-week intervals for a total of 4 treatments . St and ardized facial photographs were obtained and blindly evaluated . RESULTS Sixty-two subjects were enrolled with a mean age of 22.3 years . Fifty-five patients completed the study . The results showed a significant decrease in lesion counts compared with baseline after all treatments . However , the study did not demonstrate a statistically significant difference between the fluence parameters . The only treatment-related adverse event was temporary hyperpigmentation . CONCLUSION This study demonstrates that PDL is effective in reducing acne lesions using purpuric and subpurpuric fluences . However , there was no statistically significant difference in acne lesion count between the higher and lower fluences BACKGROUND The success rates of conventional treatments to acne vulgaris are limited because of intolerance and resistance . Photodynamic ther
Output:
| There is low certainty of the usefulness of MAL-PDT ( red light ) or ALA-PDT ( blue light ) as st and ard therapies for people with moderate to severe acne . |
MS213586 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: In order to determine whether giving iron to iron-deficient children increases their susceptibility to malaria , 213 Gambian children aged between 6 months and 5 years with iron-deficiency anaemia were r and omized to receive either oral iron or placebo during the rainy season when malaria transmission is maximal . Haematological and iron measurements improved significantly in the group given iron . Regular morbidity surveys showed that fever associated with parasitaemia occurred more frequently in the iron-treated group than in the placebo group . This difference was not significant for all parasitaemias grouped together , but became significant and progressively larger for parasitaemias of ten or more positive fields per 100 high power fields ( P less than 0.025 ) , and for parasitaemias of 50 or more positive fields per 100 high power fields ( P less than 0.01 ) . Three children in the iron-treated group but none in the placebo group had more than one episode of fever and parasitaemia . Splenomegaly rates rose appreciably during the study in both groups , but in children at age 2 years the splenomegaly rate at the end of the study was significantly greater in the iron-treated group . We concluded that there is a significantly increased risk of fever associated with severe malarial parasitaemia for children with iron-deficiency anaemia given iron during the season of maximal malaria transmission in this part of The Gambia OBJECTIVE To determine whether extended oral iron therapy corrects lower developmental test scores in infants with iron-deficiency anemia . STUDY DESIGN Double-blind , controlled trial in Costa Rica involving 32 12- to 23-month-old infants with iron-deficiency anemia and 54 nonanemic control subjects . Anemic infants were treated with orally administered iron for 6 months ; half the nonanemic children were treated with iron and half with placebo . Developmental test scores and hematologic status were evaluated before treatment , after 3 months , and after 6 months . RESULTS Iron-deficient anemic infants received lower mental test scores than nonanemic infants at all three time points ( p < 0.05 pretreatment and at 3 months , p = 0.07 at 6 months ) . There were no significant differences in motor test scores . More of the anemic infants were rated as unusually tearful and unhappy . Anemic infants came from families with lower maternal education and less support for child development and were less likely to be breast fed , were weaned earlier , and consumed more cow milk . CONCLUSIONS Lower mental test scores persisted in infants with iron-deficiency anemia despite extended oral iron therapy and an excellent hematologic response . Iron-deficiency anemia may serve as a marker for a variety of nutritional and family disadvantages that may adversely affect infant development OBJECTIVE To evaluate the effectiveness of universal prophylactic targeting with iron sulfate on daily or weekly basis in the prevention of anemia in infants . METHODS R and omized clinical field trial with children between ages six and 12 months seen at primary health care units in the municipality of Rio de Janeiro , Brazil , between 2004 and 2005 . Three concurrent cohorts were compared : daily group ( n=150 ; 12.5 mg Fe/day ) ; weekly group ( n=147 ; 25 mg Fe/week ) and control group . The intervention consisted of universal supplementation with iron sulfate for 24 weeks , combined with educational adherence-promoting measures . OUTCOME mean serum hemoglobin concentration , distribution and prevalence of anemia ( Hb<110.0 g/l ) at age 12 months . Effectiveness was evaluated considering both intent to treat and adherence to protocol , using multiple regression analysis ( linear and Poisson ) . RESULTS Groups were homogeneous in terms of descriptive variables . The intervention was implemented successfully , with high adhesion to protocol in both groups , and no statistical difference between them . After adjustment , only the daily regimen showed a protective effect . Adherence analysis demonstrated an evident dose-response effect on mean Hb and prevalence of anemia only for the daily regimen . No protective effect was detected for the weekly regimen . CONCLUSIONS Universal supplementation with iron sulfate from six to 12 months of age was effective in increasing serum Hb and decreasing risk of anemia only when administered on a daily basis The effect of iron supplementation on attending behavior of 96 1-y-old infants was assessed in a double-blind , r and omized , controlled trial of iron dextran in Papua New Guinea . The treatment group received an injection of iron dextran at 2 mo ; the controls received a placebo injection . Because many children had malarial parasitemia at testing , presence of malaria was used in the analysis . A significant interaction was found between iron and malaria infection on total fixation time : iron-supplemented groups and placebo-treated parasitemic children showed significantly higher total fixation scores than did placebo-treated aparasitemic children . Blood analysis of iron status showed similar results , with lowest iron status evident in the placebo-treated aparasitemic group . There was no effect of treatment on rate of habituation or dishabituation . Supplemental iron treatment has a significant effect on attention but the direction of the effect depends on the presence of malaria infection OBJECTIVE To assess the effect of an improved local ingredient-based gruel fortified or not with selected multiple micronutrients ( MM ) on Hb concentration of young children . DESIGN In a nutrition centre that we opened in their villages , children received either MM supplement ( containing iron , zinc , vitamin A , vitamin C and iodine ) with the improved gruel ( MMGG ) or the improved gruel only ( GG ) , twice daily , 6 d/week , for 6 months . We assessed baseline and endpoint Hb concentration and anthropometric indices . SETTING Kongoussi , a rural and poor district of Burkina Faso . SUBJECTS In a community-based trial , we r and omly assigned 131 children aged 6 - 23 months with Hb concentrations in the range of 80 - 109 g/l into two groups . RESULTS The groups did not differ significantly at baseline . Mean baseline Hb concentration was 89·2 ( sd 6·5 ) g/l and 90·3 ( sd 8·4 ) g/l in the GG and the MMGG , respectively ( P = 0·42 ) . It increased to 104·1 ( sd 11·4 ) g/l in the GG ( P < 0·001 ) and 107·6 ( sd 14·7 ) g/l in the MMGG ( P < 0·001 ) . The between-group difference of 3·5 ( 95 % CI -1·0 , 8·1 ) g/l in mean ( sd ) endpoint Hb concentration was not significant ( P = 0·13 ) . The endpoint anthropometric indices were not different between the groups . CONCLUSIONS This MM supplement had no additional effect on Hb concentration . Thorough studies are needed to evaluate the actual efficacy of the gruel before its introduction into household routine To assess the effects of iron therapy on developmental test scores in infants with iron deficiency anemia , 68 Guatemalan babies 6 to 24 months of age , with and without mild iron deficiency anemia , were tested with the Bayley Scales of Infant Development before and after one week of oral iron treatment . The two major findings of the study were developmental deficits in the anemic group prior to treatment , and lack of rapid improvement with short-term oral iron therapy . The mean pretreatment Mental Development Index of the anemic group was significantly lower than that of nonanemic infants . The anemic group 's pretreatment Psychomotor Development Index was also lower than that of the nonanemic control group . In a double-blind r and omized study , six to eight days of oral iron therapy did not reverse these deficits . Consequently , the deficits of the anemic group can not be unequivocably attributed to iron lack . However , no significant differences were found between anemic and nonanemic groups in birth histories , socioeconomic level , or general nutritional status which might otherwise explain the lower developmental test scores of the anemic babies Objective : To compare the efficacy of a daily and a weekly iron supplementation on the hematological status of anemic children living at high altitude . Design : Double blind iron supplementation trial including a placebo control group . Setting : A socioeconomically disadvantaged district of La Paz , Bolivia ( altitude of 4000 m ) . Subjects : Anemic ( hemoglobin concentration≤144 g/L ) , 3.3–8.3 y old children of both sexes . Intervention : Children received a placebo ( n=57 ) or a dose of 3–4 mg of elemental iron per kg body weight ( FeSO4 tablets ) 1 d per week ( n=58 ) or 5 d per week ( n=58 ) for 16 weeks . Results : Hemoglobin and zinc erythrocyte protoporphyrin concentrations improved significantly in supplemented groups but not in the placebo group . Changes in hemoglobin during the study were not significantly different between supplemented groups ( weekly group : 15.2±6.9 g/L and daily group : 18.6±11.1 g/L ) but were different from the placebo group ( 0.5±7.1 g/L , P<0.001 ) . At the end of the supplementation period , the hemoglobin distribution was Gaussian , and similar in both supplemented groups . Adjusting for the initial hemoglobin concentration , final hemoglobin and its changes were similar in both supplemented groups . Conclusion : Weekly iron supplementation is as efficacious as daily iron supplementation in improving iron status and correcting moderate iron deficiency anemia in Bolivian school children living at high altitude . Sponsorship : Program supported in part by ORSTROM , the French Ministry of Foreign Affairs and the National Secretary 's Office of Health , Bolivia Iron deficiency and Plasmodium falciparum malaria are the two main causes of anemia in young children in region endemic for this disease . The impact on iron status of prophylactic oral iron supplementation ( 2 mg/kg/day from two to six months of age ) and the duration of this effect were assessed in a group of 832 Tanzanian infants exposed to P. falciparum malaria . Iron parameters and red blood cell indices were assessed at 2 , 5 , 8 , and 12 months of age . Infants who received iron supplements had a significantly lower prevalence of iron deficiency ( P < 0.01 at 5 months and P < 0.001 at 8 and 12 months ) . Red blood cell indices ( mean corpuscular volume , mean cell hemoglobin , and mean cell hemoglobin concentration ) were increased in children receiving iron supplementation and they did not differ between those protected and unprotected against malaria . The prevalence of ferropenia was similar in children protected against malaria and in those who were not protected and did not receive iron supplements ( 34.7 % versus 37.3 % at 12 months of age ) . We concluded that iron supplementation between the ages of 2 - 6 months improves iron status at least up to 12 months of age . Malaria infection does not contribute to iron deficiency We conducted a r and omized controlled trial of the effects of dietary supplements on anemia , weight and height in 136 anemic school children from a low socioeconomic background in Bagamoyo District schools in Tanzania . The aim of the current study was to investigate the impact of dietary supplements on anemia and anthropometric indices of anemic school children . The supplements were vitamin A alone , iron and vitamin A , iron alone or placebo , administered in a double-blinded design for 3 mo . All supplements were provided with local corn meals . Hemoglobin concentration , body weight and height were measured at baseline and at follow-up after supplementation . Vitamin A supplementation increased the mean hemoglobin concentration by 13.5 g/L compared with 3.5 g/L for placebo [ P < 0.0001 , 95 % confidence interval ( CI ) 6.19 - 13.57 ) , the mean body weight by 0.6 kg compared with 0.2 kg for placebo ( P < 0.0001 , 95 % CI 0.19 - 0.65 ) and the mean height by 0.4 cm compared with 0.1 cm for placebo ( P = 0.0009 , 95 % CI 0.08 - 0.42 ) . However , the group of children who received combined vitamin A and iron supplementation had the greatest improvements in all indicators compared with placebo ( 18.5 g/L , P < 0.0001 , 95 % CI 14.81 - 22.23 ; 0.7 kg , P < 0 . 0001 , 95 % CI 0.43 - 0.88 and 0.4 cm , P < 0.0001 , 95 % CI 0.22 - 0.56 for hemoglobin , weight and height , respectively ) . It is likely that vitamin A supplementation may have a useful role in combating the problems of vitamin A deficiency and anemia , as well as in improving children 's growth , in developing countries BACKGROUND Micronutrient deficiencies remain common in preschool children in developing countries . Interventions focus on single micronutrients and often lack effectiveness . Weekly instead of daily supplementation may improve effectiveness . OBJECTIVE The efficacy of weekly and daily supplementation in reducing anemia prevalence and in improving the zinc , vitamin A , and growth status of 6 - 24-mo-old Vietnamese children was investigated . DESIGN In this double-blind , placebo-controlled trial , the daily group ( n = 55 ) received 8 mg elemental Fe ( as iron sulfate ) , 5 mg elemental Zn ( as zinc sul
Output:
| Overall , iron result ed in fewer anaemic children at follow up , and the end average change in haemoglobin from base line was higher with iron .
Authors ' conclusions Iron treatment does not increase the risk of clinical malaria when regular malaria prevention or management services are provided .
Where re sources are limited , iron can be administered without screening for anaemia or for iron deficiency , as long as malaria prevention or management services are provided efficiently .
12 April 2019 No up date planned Other There is high‐certainty evidence that oral iron supplements do not adversely affect children living in malaria‐endemic areas , meaning further research is unlikely to change our confidence in the estimate of effect . |
MS213587 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: We have studied the effect of propofol on the side effects associated with intrathecal morphine in 40 patients undergoing major arthroplasty . Patients received spinal anaesthesia with plain 0.5 % bupivacaine 20 mg mixed with preservative-free morphine 0.3 mg . Before injection of the local anaesthetic , the patients were allocated r and omly to receive either a bolus dose of propofol 10 mg followed by an infusion of 30 mg/24 h or equal volumes of 10 % Intralipid ( control group ) . The number of patients without postoperative nausea and vomiting ( PONV ) was similar in both groups . However , the incidence of nausea and vomiting was lower in the propofol ( 13 and 22 , respectively ) than in the control ( 34 and 36 ) group ( P < 0.01 and P < 0.05 , respectively ) . Severe vomiting episodes were less frequent in the propofol group ( 1 vs 11 ; P < 0.05 ) . Four patients in the propofol group and 12 patients in the control group had itching ( P < 0.05 ) . The incidence of urinary retention was similar in both groups . There was no additional sedation attributable to propofol . In conclusion , sub-hypnotic doses of propofol protected significantly against itching and had a modest effect on PONV after intrathecal morphine The purpose of this study was to determine whether subhypnotic doses of propofol effectively relieve pruritus in women who received intrathecal morphine for postoperative analgesia after cesarean delivery . Twenty-nine women who developed pruritus after undergoing an elective cesarean section and receiving intrathecal morphine ( 0.25 mg ) for postoperative analgesia were enrolled in this r and omized , prospect i ve , double-blind study . The women were r and omly assigned to receive either 1 mL of propofol ( n=17 ) or 1 mL of placebo ( n=12 ) IV . Pruritus was evaluated 5 min after treatment . In the absence of successful treatment , the women received another 1 mL of the same drug . Pruritus was again evaluated 5 min after the second dose . We found that pruritus was successfully treated twice in the propofol group and once in the placebo group ( P = not significant ) . The antipruritic action of propofol lasted for up to 6 h in one woman and 15 min in the other . The one success in the placebo group lasted for 15 min . We conclude that the success rate of propofol in treating pruritus in women who received intrathecal morphine for postoperative analgesia after cesarean delivery is not significantly different from that of placebo . Implication s : Pruritus is a common and bothersome side effect of neuraxial opioids after cesarean section . Subhypnotic doses of IV propofol ( 10 mg ) have been used to treat pruritus caused by neuraxial opioids . In this prospect i ve , r and omized , double-blind study , we found that propofol does not relieve pruritus in women who underwent cesarean section and received intrathecal morphine sulfate ( 0.25 mg ) for postoperative pain relief . ( Anesth Analg 1998;86:310 - 3 In order to evaluate the effect of preventive corticosteroid on the occurrence of pruritus after epidural anesthesia with morphine , we studied 95 patients undergoing cesarean section . Thirty-seven patients ( group I ) were given 20 mg of bupivacaine 0.5 % for the operation and 2 mg of morphine hydrochloride with 50 mg of Ultracortene-H immediately after the operation and 24 h later , and 58 patients ( group II ) were given epidural bupivacaine during the operation and epidural morphine hydrochloride immediately after the operation and 24 h later without Ultracortene-H. Only 8.1 % of group I patients had pruritus after the injection compared to 20.6 % in group II . We suggest that the addition of 50 mg Ultracortene-H to 2 mg epidural morphine analgesia after the operation might prevent severe forms of pruritus A majority of patients experience pruritus , nausea and /or emesis following epidural morphine administration post-cesarean section . Naloxone or diphenhydramine are commonly used to treat these side effects . Prevention or reduction in the incidence of side effects of epidural morphine is a clinical goal . The purpose of the study was to observe the efficacy of prophylactic administration of hydroxyzine on the incidence and severity of pruritus following the epidural administration of morphine in 40 patients who requested epidural morphine for postoperative pain relief . Group I ( n = 20 ) received saline , while Group II ( n = 20 ) received 50 mg of hydroxyzine ten minutes after the administration of 5 mg epidural morphine . Both solutions were administered by deep intramuscular injection in the thigh area . The results of this investigation demonstrated that hydroxyzine was efficacious in attenuating the incidence of severe pruritus Background and Objectives . Epidural morphine is accepted as an efficient means of postoperative pain management . However , development of side effects such as nausea and vomiting and pruritus has been reported . This study compared the efficacy of intravenous infusions of nalbuphine or naloxone in the prevention of epidural morphine‐related side effects . Methods . Seventy‐five female patients undergoing epidural anesthesia for total hysterectomy were enrolled in a r and omized , double‐blind study . At the end of the surgery , all patients received epidural 3 mg morphine ( every 12 hours ) for postoperative pain . Meanwhile , patients in group 1 received an adjuvant intravenous infusion of nalbuphine 60 μg/kg/h , patients in group 2 received intravenous infusion of naloxone 2 μg/kg/h , and patients in group 3 received intravenous saline infusion only . A rescue analgesic of intramuscular 50 mg meperidine ( every 4 hours ) was available for each patient . Patients were observed for 24 hours . Results . All patients had adequate postoperative pain relief . However , the proportion of patients requiring rescue analgesia and the total consumption of rescue analgesic were higher in group 2 than in the other two groups . The incidence of nausea and vomiting and pruritus was higher in group 3 than in the other two groups . Conclusions . We found that coadministration of either nalbuphine or naloxone with epidural morphine reduces the incidence of morphine‐related side effects . However , unlike naloxone , nalbuphine did not attenuate the analgesic effect of epidural morphine This study was design ed to evaluate the efficacy of nalmefene vs. naloxone in preventing side effects result ing from intrathecal opioids , in patients undergoing cesarean delivery . Eighty patients who were scheduled for elective cesarean delivery under spinal anesthesia were included in a double-blind , placebo-controlled study . Patients were r and omized into four groups : saline ; intravenous nalmefene 0.25 micro.kg(-1 ) every 12 h x 2 ; intravenous nalmefene 0.5 microg.kg(-1 ) every 12 h x 2 ; and naloxone infusion 48 microg.h(-1 ) ( 1.2 microg.ml(-1 ) ) . There were no significant differences among the groups with respect to pain , sedation , satisfaction , or the occurrence or treatment of pruritus or nausea . There was a significant difference among the groups with respect to the occurrence of vomiting ( P < 0.03 ) : both nalmefene groups had a higher rate of vomiting than did the control group ; the 0.25 microg.kg(-1 ) nalmefene group had a higher rate than did the naloxone group . The use of narcotic antagonists does not result in improved comfort in obstetrical patients receiving intrathecal morphine and fentanyl Background and Objectives Because the mechanism of inhibition of epidural morphine-induced pruritus by droperidol is not clear , this study was undertaken to determine the effects of larger doses of droperidol or morphine , or both . Methods A double-blind study was performed in 210 ASA I or II patients undergoing cesarean delivery , who were r and omly assigned to six groups . All patients received epidural anesthesia with 0.5 % bupivacaine containing 1:200,000 epinephrine , to which 2 mg ( groups 1 , 2 , and 3 ) or 4 mg ( groups 4 , 5 , and 6 ) morphine sulfate was added . Just after delivery , 2.5 mg droperidol was given intravenously to groups 2 and 5 , and 5 mg was given to groups 3 and 6 . During the postoperative period , the patients were assessed for the occurrence and severity of pruritus ( classified as absent , mild , moderate , or severe ) or other untoward symptoms . The groups were compared for the incidence of pruritus by the Mann-Whitney nonparametric test . Results The incidence of pruritus was significantly reduced only when the control group ( no droperidol ) was compared with the group that received 2.5 mg droperidol , both when 2 mg and when 4 mg morphine was used . A 5-mg dose of droperidol had no inhibitory effect . There was no difference in the incidence of pruritus between use of 2 mg and 4 mg morphine . Other untoward effects of morphine either could not be observed or occurred with an incidence unaffected by either dose of droperidol . Conclusion Pruritus caused by epidural use of 2 or 4 mg of morphine is inhibited by the intravenous use of 2.5 mg droperidol but not by a larger dose Propofol is associated with a low incidence of postoperative nausea and vomiting . In a prospect i ve , r and omized , double-blind , placebo-controlled study , we investigated the possible direct antiemetic properties of a subhypnotic dose of propofol . Fifty-two ASA physical status I or II patients , aged 15–60 yr with nausea and vomiting after minor gynecologic , orthopedic , or digestive tract surgery , were included in the study and received either propofol ( 10 mg = 1 mL ) or placebo ( 1 mL Intralipid ) intravenously in the postanesthesia care unit . Patients treated with propofol experienced a larger reduction in nausea and vomiting than patients treated with placebo ( 81 % vs 35 % success rate ; P < 0.05 ) . Patients successfully treated had a similar incidence of relapse ( propofol 28 % ; placebo 22 % ) within the first 30 min after therapy . Thirty-three percent of the propofol-treated patients and 44 % of the placebo-treated patients showed a minor increase in sedation . The level of postoperative pain did not change in either group . Hemodynamic values remained unchanged in both groups . Pain on injection ( 7.6 % ) or dizziness ( 3.6 % ) only occurred in the propofol group . We conclude that propofol has significant direct antiemetic properties The influence of two different concentrations of iv naloxone infusion on the analgesia and adverse effects of epidural morphine were compared in a double-blind , placebo-controlled study . Fortyfive patients undergoing gallbladder surgery were provided postoperative analgesia by 4 mg epidural morphine ; they then received an iv infusion over a 12-h period consisting of either 5 μg · kg−1 · h−1 naloxone , 10 μg · kg−1 · h−1 naloxone , or saline . Pain relief was assessed by hourly visual analog scoring ( VAS ) and by direct question ing of the patient . Requirement of additional analgesia was noted . Respiratory frequency was monitored every 15 min and arterial blood gases were analyzed every 2 h for 24 h. Peak expiratory flow ( PEF ) was recorded 6 and 24 h postoperatively . Steady-state kinetics of naloxone were determined by a modified radioimmunoassay ( RIA ) method . All patients had good to excellent postoperative pain relief . Naloxone , 5 μg · kg−1 · h−1 , did not appear to have any effect on epidural morphine analgesia . However , naloxone infusion at the rate of 10 μg.kg−1 h−1 reduced the duration of analgesia by about 25 % , and more frequent injections of epidural morphine were required to give effective analgesia . Complete reversal of analgesia was not seen in any patient . A dose-related stimulatory effect on respiratory frequency was noted in the groups receiving naloxone . Paco2 values also were better in these groups as compared to values in the placebo group . The steady-state plasma concentration of naloxone was 2.8–3.7 ng/ml during infusion at the rate of 5μg.kg−1 h−1 and 4.3–5.1 ng/ml during 10 μg · kg−1 h−1 naloxone infusion . The plasma clearance of naloxone was 30.5 and 35.4 ml . min−1 . kg−1 for the low and high dose groups , respectively , and showed a four-fold interindividual variation . The authors conclude that naloxone reverses epidural morphine analgesia in a dose-dependent manner .
Output:
| There was a lack of evidence for any anti-pruritic efficacy with prophylactic propofol , epidural or intrathecal epinephrine , epidural clonidine , epidural prednisone , intravenous ondansetron , or intramuscular hydroxyzine .
CONCLUSION Naloxone , naltrexone , nalbuphine and droperidol are efficacious in the prevention of opioid-induced pruritus ; minimal effective doses remain unknown .
There is a lack of valid data on the efficacy of interventions for the treatment of established pruritus |
MS213588 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background 10 Hz electroencephalographic ( EEG ) alpha rhythms correlate with memory performance . Alpha and memory decline in older people . We wished to test if alpha-like EEG activity contributes to memory formation . Flicker can elicit alpha-like EEG activity . We tested if alpha-frequency flicker enhances memory in older people . Pariticpants aged 67–92 identified short words that followed 1 s of flicker at 9.0 Hz , 9.5 Hz , 10.0 Hz , 10.2 Hz , 10.5 Hz , 11.0 Hz , 11.5 Hz or 500 Hz . A few minutes later , we tested participants ' recognition of the words ( without flicker ) . Results Flicker frequencies close to 10 Hz ( 9.5–11.0 Hz ) facilitated the identification of the test words in older participants . The same flicker frequencies increased recognition of the words more than other frequencies ( 9.0 Hz , 11.5 Hz and 500 Hz ) , irrespective of age . Conclusion The frequency-specificity of flicker 's effects in our participants paralleled the power spectrum of EEG alpha in the general population . This indicates that alpha-like EEG activity may subserve memory processes . Flicker may be able to help memory problems in older people Pre‐operative anxiety is common and often significant . Ambulatory surgery challenges our pre‐operative goal of an anxiety‐free patient by requiring people to be ‘ street ready ’ within a brief period of time after surgery . Recently , it has been demonstrated that music can be used successfully to relieve patient anxiety before operations , and that audio embedded with tones that create binaural beats within the brain of the listener decreases subjective levels of anxiety in patients with chronic anxiety states . We measured anxiety with the State‐Trait Anxiety Inventory question naire and compared binaural beat audio ( Binaural Group ) with an identical soundtrack but without these added tones ( Audio Group ) and with a third group who received no specific intervention ( No Intervention Group ) . Mean [ 95 % confidence intervals ] decreases in anxiety scores were 26.3%[19–33 % ] in the Binaural Group ( p = 0.001 vs. Audio Group , p < 0.0001 vs. No Intervention Group ) , 11.1%[6–16 % ] in the Audio Group ( p = 0.15 vs. No Intervention Group ) and 3.8%[0–7 % ] in the No Intervention Group . Binaural beat audio has the potential to decrease acute pre‐operative anxiety significantly Users of a commercial light therapy device who were using it to treat migraine were surveyed prospect ively to determine what results they obtained after 30 days of daily use . Out of a total of 55 migraineurs , 44 % reported that the frequency of their migraine attacks after the treatment was ' Somewhat Less ' or ' Much Less ' ( under a conservative interpretation of these categories ) . Considering only the 28 migraineurs who stated that their migraine attacks were normally preceded by warning signs , 53 % reported that the frequency of their migraine attacks was ' Somewhat Less ' or ' Much Less ' . In view of the limited efficacy and undesirable side-effects of the available migraine preventive drugs , photic stimulation ( flickering light therapy ) must be considered a possible preventive treatment for migraine INTRODUCTION Binaural beat technology ( BBT ) products are sold internationally as personal development and health improvement tools . Producers suggest benefit from regular listening to binaural beats including reduced stress and anxiety , and increased focus , concentration , motivation , confidence , and depth in meditation . Binaural beats are auditory brainstem responses that originate in the superior olivary nucleus as a result of different frequency auditory stimuli provided to each ear . Listeners to binaural beat " hear " a beat at a frequency equal to the difference between the frequencies of the applied tones . OBJECTIVES The objectives of this pilot study were to gather preliminary data on psychologic and physiologic effects of 60 days daily use of BBT for hypothesis generation and to assess compliance , feasibility , and safety for future studies . DESIGN Uncontrolled pilot study . SUBJECTS Eight healthy adults participated in the study . INTERVENTION Participants listened to a CD with delta ( 0 - 4 Hz ) binaural beat frequencies daily for 60 days . OUTCOME MEASURES Psychologic and physiological data were collected before and after a 60-day intervention . PSYCHOLOGIC : Depression ( Beck Depression Inventory-2 ) , anxiety ( State-Trait Anxiety Inventory ) , mood ( Profile of Mood States ) , absorption ( Tellegen Absorption Scale ) and quality of Life ( World Health Organization- Quality of Life Inventory ) . PHYSIOLOGICAL : Cortisol , dehydroepi and rosterone , melatonin , insulin-like growth factor-1 , serotonin , dopamine , epinephrine , norepinephrine , weight , blood pressure , high sensitivity C-reactive protein . RESULTS There was a decrease in trait anxiety ( p = 0.004 ) , an increase in quality of life ( p = 0.03 ) , and a decrease in insulin-like growth factor-1 ( p = 0.01 ) and dopamine ( p = 0.02 ) observed between pre- and postintervention measurements . CONCLUSIONS Binaural beat technology may exhibit positive effect on self-reported psychologic measures , especially anxiety . Further research is warranted to explore the effects on anxiety using a larger , r and omized and controlled trial OBJECTIVES This report presents both age-adjusted and unadjusted statistics from the 2002 National Health Interview Survey on selected health measures for children under 18 years of age , classified by sex , age , race , Hispanic origin , family structure , parent 's education , family income , poverty status , health insurance coverage , place of residence , region , and current health status . The topics covered are asthma , allergies , learning disability , Attention Deficit Hyperactivity Disorder ( ADHD ) , use of prescription medication , respondent-assessed health status , school-loss days , usual place of health care , time since last contact with a health care professional , unmet dental needs , time since last dental contact , and selected measures of health care access . SOURCE OF DATA The NHIS is a multistage probability sample survey conducted annually by interviewers of the U.S. Census Bureau for the Centers for Disease Control and Prevention 's National Center for Health Statistics and is representative of the civilian noninstitutionalized population of the United States . Data are collected during face-to-face interviews with adults present at the time of interview . Information about children is collected for one r and omly selected child per family in face-to-face interviews with an adult proxy respondent familiar with the child 's health . SELECTED HIGHLIGHTS In 2002 , most U.S. children under 18 years of age had excellent or very good health ( 84 % ) . However , 10 % of children had no health insurance coverage , and 5 % of children had no usual place of health care . Twelve percent of children had ever been diagnosed with asthma . An estimated 8 % of children 3 - 17 years of age had a learning disability , and an estimated 7 % of children had ADHD In an open study 17 women with confirmed , severe and long-st and ing premenstrual syndrome used photic stimulation with a flickering red light , every day for up to four menstrual cycles . At the end of treatment prospect ively recorded median luteal symptom scores were reduced by 76 % ( 95 % confidence interval 54 - 93 , P < 0.001 ) , with clinical ly and statistically significant reductions for depression , anxiety , affective lability , irritability , poor concentration , fatigue , food cravings , bloating and breast pain . Twelve of the 17 patients ( 71 % ) no longer had the premenstrual syndrome . One patient failed to improve . One patient withdrew because of worsening premenstrual depression , but photic stimulation was otherwise well tolerated . The improvement is greater than that reported for relaxation or in open studies of fluoxetine , and much more than historical placebo rates . Photic stimulation may be a useful treatment for the premenstrual syndrome , and by its suggested action on circadian rhythms may have wider therapeutic applications Stress and burnout are widely acknowledged as major causes of societal and individual problems in the Western world . In order to reduce material and i m material expenses , increased efforts are made to enhance relaxation and stress reduction . Based on neuropsychological findings , alternative ways have been explored , one of them being the application of so-called brain wave synchronizers , which are said to induce a relaxation response by entraining alpha brain-wave activity ( 8–13 Hz ) through audiovisual stimulation . A double blind , quasi-experiment was conducted among employees at a Dutch addiction care center to investigate the possible effects of two distinct brainmachine programs on burnout and anxiety . Subjects in both conditions showed a significant , immediate decrease in state anxiety as assessed by Spielberger 's State-Trait Anxiety Inventory ( STAI ) and reported a range of subjective effects . However , a long-term effect on burnout , as measured with Maslach 's Burnout Inventory ( MBI-NL ) , could not be established . A long-term effect on anxiety ( STAI ) , as investigated by interrupted time-series measurement , could not be established either . These and other findings suggest that the major cl aims with respect to these machines can not hold over time , although pleasant short-term effects do occur . Individual differences in baseline responsivity , the stable character of burnout dimensions , or the ill-defined nature of relaxation , or a combination of these , may account for these results OBJECTIVES When two auditory stimuli of different frequency are presented to each ear , binaural beats are perceived by the listener . The binaural beat frequency is equal to the difference between the frequencies applied to each ear . Our primary objective was to assess whether steady-state entrainment of electroencephalographic activity to the binaural beat occurs when exposed to a specific binaural beat frequency as has been hypothesized . Our secondary objective was to gather preliminary data on neuropsychologic and physiologic effects of binaural beat technology . DESIGN A r and omized , blinded , placebo-controlled crossover experiment in 4 healthy adult subjects . INTERVENTION Subjects were r and omized to experimental auditory stimulus of 30 minutes of binaural beat at 7 Hz ( carrier frequencies : 133 Hz L ; 140 Hz R ) with an overlay of pink noise resembling the sound of rain on one session and control stimuli of the same overlay without the binaural beat carrier frequencies on the other session . OUTCOME MEASURES Data were collected during two separate sessions 1 week apart . Neuropsychologic and blood pressure data were collected before and after the intervention ; electroencephalographic data were collected before , during , and after listening to either binaural beats or control . Neuropsychologic measures included State Trait Anxiety Inventory , Profile of Mood States , Rey Auditory Verbal List Test , Stroop Test , and Controlled Oral Word Association Test . Spectral and coherence analysis was performed on the electroencephalogram ( EEG ) , and all measures were analyzed for changes between sessions with and without binaural beat stimuli . RESULTS There were no significant differences between the experimental and control conditions in any of the EEG measures . There was an increase of the Profile of Mood States depression subscale in the experimental condition relative to the control condition ( p = 0.02 ) . There was also a significant decrease in immediate verbal memory recall ( p = 0.03 ) in the experimental condition compared to control condition . CONCLUSIONS We did not find support for steady-state entrainment of the scalp-recorded EEG while listening to 7-Hz binaural beats . Although our data indicated increased depression and poorer immediate recall after listening to binaural beats , larger studies are needed to confirm these findings OBJECTIVES This report presents both age-adjusted and unadjusted statistics from the 2005 National Health Interview Survey ( NHIS ) on selected health measures for children under 18 years of age , classified by sex , age , race , Hispanic origin , family structure , parent education , family income , poverty status , health insurance coverage , place of residence , region , and current health status . The topics covered are asthma , allergies , learning disability , Attention Deficit Hyperactivity Disorder ( ADHD ) , prescription medication use , respondent-assessed health status , school-loss days , usual place of health care , time since last contact with a health care professional , selected measures of health care access and utilization , and dental care . SOURCE OF DATA NHIS is a multistage probability sample survey conducted annually by interviewers of the U.S. Census Bureau for the Centers for Disease Control and Prevention 's National Center for Health Statistics and is representative of the civilian noninstitutionalized population of the United States . Data are collected for all family members during face-to-face interviews with adults present at the time of interview . Additional information about children is collected for one r and omly selected child per family in face-to-face interviews with an adult proxy respondent familiar with the child 's health . SELECTED HIGHLIGHTS In 2005 , most U.S. children under 18 years of age had excellent or very good health ( 82 % ) . However , 9 % of children had no health insurance coverage , and 5 % of children had no usual place of health care . Thirteen percent of children had ever been diagnosed with asthma . An estimated 7 % of children 3 - 17 years of age had a diagnosed learning disability , and an estimated 7 % of children had ADHD The effects of a brain wave synchronizer ( BWS ) on endodontic ( root canal ) anxiety was evaluated in the clinical practice s of the senior author . The experimental groups were : ( 1 ) a verbal method ( routine calming words by dentist ) plus BWS ( N = 10 ) and ( 2 ) verbal method plus BWS and alpha relaxation tape ( N = 10 ) . The control group was verbal method alone ( N = 10 ) . All three groups were evaluated during a complete endod
Output:
| Findings to date suggest that BWE is an effective therapeutic tool .
People suffering from cognitive functioning deficits , stress , pain , headache/migraines , PMS , and behavioral problems benefited from BWE . |
MS213589 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Venous thromboembolic disease remains the most common reason for readmission after total hip arthroplasty . Prospect i ve analysis of screening contrast venography was done from 1984 to 2003 in 1972 patients having elective total hip arthroplasty . Patients with deep venous thrombosis or pulmonary embolism received warfarin therapy ; those with negative venograms received no further anticoagulation . From 1984 to 1992 , patients not completing venography were discharged without warfarin ; since 1993 , patients without venography received warfarin for 6 weeks . Readmission for deep venous thrombosis , pulmonary embolism , or bleeding was tracked for 6 months . Venograms were completed in 1032 patients ; 175 ( 16.9 % ) had deep venous thrombosis . Deep venous thrombosis was reduced by a clinical pathway that included continuous epidural anesthesia ( 14.2 % versus 22.5 % ) . The overall readmission rate for venous thromboembolic disease was 1.62 % , including 14 pulmonary emboli ( three fatal ) and 18 femoral deep venous thrombosis . Readmission occurred in 0.27 % ( 1 of 360 ) patients on continued warfarin , compared with 2.2 % ( 19 of 880 ) with negative venograms discharged without further anticoagulation . Three patients ( 0.15 % ) suffered fatal pulmonary emboli ; all had negative venograms and received no outpatient prophylaxis . Extended outpatient warfarin therapy provided effective protection against venous thromboembolic disease readmission . Surveillance venography was a poor predictor of need for continued prophylaxis ; all patients should have extended anticoagulation after total hip arthroplasty . Level of Evidence : Therapeutic study , Level I-1 ( high- quality r and omized trial with statistically significant difference or no statistically significant difference but narrow confidence intervals ) . See the Guidelines for Authors for a complete description of levels of evidence There are many reports concerning the aetiology and prophylaxis of deep-vein thrombosis ( DVT ) but little is known about its natural history . The purpose of our study was to identify the incidence and site of DVT , the risk factors for pulmonary embolism and the natural history of DVT after total hip replacement ( THR ) in patients who do not receive any form of prophylactic or therapeutic treatment for DVT . Two hundred patients who had a primary THR were included : 100 had one-staged bilateral THR and 100 had unilateral THR and 150 implants were cemented and 150 cementless . Coagulation assays , a full blood count , blood typing and serum chemical profile tests were performed for all patients on three separate occasions . Bilateral simultaneous or unilateral venograms were performed on the sixth or seventh postoperative day and perfusion lung scans preoperatively and on the seventh or eighth postoperative day . Further venograms were performed in all patients who had thrombi six months later . In the patients with bilateral THR , 52 ( 26 % ) venograms were positive for thrombi , while in the patients with unilateral THR 20 ( 20 % ) were positive ( p = 0.89 ) . In the patients with a cemented THR , 31 venograms ( 20.7 % ) were positive for thrombi , while in those with a cementless THR 41 ( 27.3 % ) were positive ( p = 0.654 ) . Further venograms in all 72 patients who had thrombi at six months after operation showed that they resolved completely and spontaneously regardless of their site and size . No patients had symptoms of pulmonary emboli and none were seen on the perfusion lung scans . Two patients died from unrelated causes . Although the prevailing opinion is that patients with proximal venous thrombosis should be treated with anticoagulants , our study has shown that all thrombi regardless of their site and size resolve spontaneously without associated pulmonary embolism Intraoperative pulmonary embolism occurs not only during cemented but also during cementless total hip arthroplasty ( THA ) . We determined whether the ROBODOC femoral milling system can reduce intraoperative pulmonary embolism , by using of transesophageal echocardiography and hemo-dynamic monitoring . We did a prospect i ve clinical trial with 71 patients ( 75 hips ) who were divided into 2 groups : group 1 , 46 patients ( 50 hips ) who underwent cementless THA with preparation of the femoral canal using ROBODOC ; group 2 , 25 patients ( 25 hips ) who underwent conventional cementless THA surgery in whom separate measurements were made during preparation of the femur , insertion of the stem and relocation of the hip . The incidence of severe embolic events was lower in group 1 than in group 2 . Our findings suggest that the ROBODOC femoral milling system may reduce the risk of clinical ly significant pulmonary embolism during cementless Introduction This prospect i ve study was design ed to confirm risk factors and to assess the incidence of deep vein thrombosis after total hip and surface replacement arthroplasty in Korean patients not receiving anticoagulation prophylaxis and to determine efficacy of plasma D-dimer levels as a screening test . Material s and methods From May 2003 to August 2004 , 221 consecutive patients undergoing unilateral total hip arthroplasty and hip resurfacing were evaluated . All patients underwent ultrasonography preoperatively and venography and /or ultrasonography on postoperative day 7 . Plasma D-dimer levels were estimated by latex immuno-assay preoperatively and on days 3 and 7 postoperatively . Results Of the 221 patients in our cohort , 23 developed deep vein thrombosis ( 10.4 % ) . Age ( r = 0.245 , P < 0.001 ) and gender ( r = 0.155 , P = 0.021 ) significantly correlated with deep vein thrombosis . Rise in incidence paralleled increase in age ( X2 = 32.860 , P < 0.001 ) . D-dimer levels on postoperative days 3 ( γ = 0.364 , P < 0.001 ) and 7 ( γ = 0.470 , P < 0.001 ) were significantly correlated to the development of DVT . Conclusion While incidence of deep vein thrombosis in Korean population after THA was lower than that in the West ; it increased with age , and in female gender . Significant correlation was found between D-dimer levels and the development of deep vein thrombosis Introduction : The incidence of venous thromboembolism ( VTE ) in Western population s undergoing major orthopaedic surgery without any thromboprophylaxis has been reported to range from 32 % to 88 % . There is however limited information on incidence of VTE in Indian patients and most of the Indian patients undergoing these surgeries do not receive any form of prophylaxis regardless of their risk profile . Methods : A prospect i ve study was performed on 147 patients undergoing major orthopaedic surgery for total knee replacement ( TKR ) , total hip replacement ( THR ) , and proximal femur fracture fixation ( PFF ) without any prophylaxis . These patients were profiled for presence of the known risk factors responsible for development of VTE . A duplex ultrasound on both lower limbs was done 6 to 10 days after surgery . Twenty three patients underwent THR , 22 patients underwent TKR , and 102 underwent surgery for PFF . The patients were assessed clinical ly for any signs of deep venous thrombosis ( DVT ) and pulmonary embolism ( PE ) . A helical CT scan was done in case of suspicion of PE and a duplex ultrasound was done in case of clinical suspicion of DVT irrespective of the stage of study . Results : The overall incidence of VTE was 6.12 % and that of PE was 0.6 % . The risk factors that were found to be significantly responsible for development of VTE ( p < 0.05 ) were : immobility greater than 72 hours , malignancy , obesity , surgery lasting more than two hours . Conclusion : The study reconfirms the belief that DVT has a lower incidence in Indian patients as compared with other ethnic groups BACKGROUND In view of recent substantial changes in the management of orthopedic surgery patients , a study was performed in order to up date data on the epidemiology of venous thromboembolism ( VTE ) in patients undergoing lower limb arthroplasty according to contemporary practise . METHODS We performed a prospect i ve observational study of a cohort of consecutive patients hospitalized for total hip or knee replacement in June 2003 . The primary study outcome was the incidence of symptomatic VTE at 3 months . All events were adjudicated by an independent critical event committee . RESULTS Data from 1080 patients ( mean age 68.0 years ) were available ; 63.2 % were undergoing total hip replacement and 36.8 % total knee replacement . Pharmacological thromboprophylaxis was administered for a mean time of 36 days . Injectable antithrombotics were used in more than 99 % of patients , irrespective of the type of surgery . The incidence of the primary study outcome was 1.8 % ( 20 events ; 95 % CI : 1.0 - 2.6 % ) . The incidences were 1.3 % and 2.8 % in hip and knee surgery patients , respectively . There were two pulmonary embolisms , both in knee surgery patients ; neither was fatal . Thirty-five per cent of VTEs occurred after hospital discharge . An age of at least 75 years and the absence of ambulation before hospital discharge were the only significant ( P < 0.05 ) predictors of VTE . The rate of clinical ly significant bleeding was 1.0 % and the rate of death was 0.9 % . CONCLUSIONS The incidence of symptomatic VTE after lower limb arthroplasty is low , even if there is still a need to improve thromboprophylaxis , notably in patients undergoing knee arthroplasty Background Heparin-induced thrombocytopenia ( HIT ) is a thromboembolic complication that can occur with unfractionated heparin ( UFH ) or low molecular weight heparin ( LMWH ) . Our objective was to determine and compare the incidence of IgG-class HIT antibodies in patients undergoing total hip arthroplasty ( THA ) or total knee arthroplasty ( TKA ) with different antithrombotic prophylaxis therapies and their contributions to the occurrence of venous thromboembolism ( VTE ) . Methods A prospect i ve observational study was performed for 374 Japanese patients undergoing THA or TKA to determine the incidence of VTE . IgG-class anti-PF4/heparin antibodies were measured using IgG-specific EIA before and after the operation . Results In the clinical outcome , the incidence of symptomatic deep vein thrombosis ( DVT ) was 15.0 % ( 56/374 , TKA ; 35 , THA ; 21 ) and pulmonary emboli ( PE ) were not observed . The total seroconversion incidence of IgG-class PF4/heparin antibodies was 19.8 % ( 74/374 ) . The seroconversion incidence of IgG-class PF4/heparin antibodies was higher in patients receiving UFH ( 32.7 % ) compared to those receiving LMWH ( 9.5 % ) or fondaparinux ( 14.8 % ) . Furthermore , the seroconversion incidence was significantly higher in patients undergoing TKA compared to those undergoing THA . Based on multivariate analysis , seroconversion of the IgG-class PF4/heparin antibodies was independent a risk factor for symptomatic DVT . Conclusion Our findings show that the seroconversion of IgG-class anti-PF4/heparin antibodies differed with various anti-thrombotic prophylaxis therapeutics and was associated with the risk of DVT in a subset of patients undergoing total joint arthroplasty ( TKA and THA ) Venous thromboembolism ( VTE ) is an important complication of major orthopaedic surgery of the lower limbs . Fondaparinux , a synthetic pentasaccharide and highly selective inhibitor of activated Factor Xa , is the first in a new class of antithrombotic agents . To determine the optimal dose in Japanese patients , double-blind , placebo-controlled , dose-ranging studies of fondaparinux were conducted in patients undergoing total knee replacement ( TKR ) or total hip replacement ( THR ) surgery . Patients were r and omly assigned to receive a once-daily subcutaneous injection of fondaparinux ( 0.75 , 1.5 , 2.5 , or 3.0 mg ) or placebo in Study 1 ( TKR ) and Study 2 ( THR ) . In Study 1 , the incidence of VTE was 65.3 % in the placebo group and was 34.2 % , 21.3 % , 16.2 % , and 9.5 % in the groups receiving 0.75 , 1.5 , 2.5 , and 3.0 mg fondaparinux respectively . In Study 2 , the incidence of VTE was 33.8 % in the placebo group and was 24.2 % , 4.6 % , 7.4 % ,
Output:
| VTE history was found as a VTE risk factor of THA but an controversial factor of TKA .
Cemented fixation as compared to cementless fixation was found as a risk factor for VTE only of TKA .
TKA surgery itself was confirmed as a VTE risk factor compared with THA surgery .
Conclusions This systematic review of high level evidence s published in recent ten years identified a range of potential factors associated with VTE risk of total joint arthroplasty . |
MS213590 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Multiple sclerosis ( MS ) presents with optic neuritis ( ON ) in 20 % of cases and 50 % of ON patients develop MS within 15 years . In this study , we evaluated the preventive effects of vitamin D3 administration on the conversion of ON to MS ( primary outcome ) and on the MRI lesions ( secondary outcome ) of ON patients with low serum 25 ( OH ) D levels . Thirty ON patients ( 15 in each of 2 groups , aged 20–40 years ) with serum 25 ( OH ) D levels of less than 30 ng/ml were enrolled in a double blind , r and omized , parallel-group trial . The treatment group ( cases ) received 50,000 IU of vitamin D3 weekly for 12 months and the control group ( controls ) received a placebo weekly for 12 months . Finally , the subsequent relapse rate and changes in MRI plaques were compared between the two groups . Risk reduction was 68.4 % for the primary outcome in the treatment group ( relative risk = 0.316 , p = 0.007 ) . After 12 months , patients in the treatment group had a significantly lower incidence rate of cortical , juxtacortical , corpus callosal , new T2 , new gadolinium-enhancing lesions and black holes . The mean number of total plaques showed a marginally significant decrease in the group receiving vitamin D3 supplementation as compared with the placebo group ( p = 0.092 ) . Administration of vitamin D3 supplements to ON patients with low serum vitamin 25 ( OH ) D levels may delay the onset of a second clinical attack and the subsequent conversion to MS Background Flu-like symptoms ( FLS ) are common side effects of interferon beta ( IFN-β ) treatment in patients with Multiple Sclerosis ( PwMS ) and are associated with post-injection cytokine surge . We hypothesized that vitamin D3 supplementation would ameliorate FLS by decreasing related serum cytokines ’ levels . Methods In a r and omized , double blind study of 45 IFNβ-treated PwMS , 21 patients were assigned to 800 IU of vitamin D3 per day ( low dose ) , while 24 patients received 4,370 IU per day ( high dose ) for one year . FLS were assessed monthly by telephonic interviews . Serum levels of 25-hydroxy-D ( 25-OH-D ) , calcium , PTH , IL-17 , IL-10 and IFN-γ were measured periodically . EDSS , relapses , adverse events and quality of life ( QoL ) were documented . Results 25-OH-D levels increased to a significantly higher levels and PTH levels decreased in the high dose group . There was no significant change in FLS . IL-17 levels were significantly increased in the low dose group , while patients receiving high dose vitamin D had a heterogeneous IL-17 response . No significant differences in relapse rate , EDSS , QoL , serum IL-10 and IFNγ were found . Hypercalcemia or other potential major adverse events were not observed . Conclusion Vitamin D supplementation to IFN−β treated PwMS , at the doses used , seems safe and associated with dose-dependent changes in IL-17 serum levels , while not affecting IFN−β related FLS.Trial registration Clinical Trials.gov ID : Abstract Objectives To explore the association between dietary factors including fat , fruit and vegetable intake , dairy and meat consumption , and health-related quality of life ( HRQOL ) , disability and relapse rate in a large international sample of people with multiple sclerosis ( MS ) . Methods Participants with MS were recruited to the study via Web 2.0 platforms and completed a comprehensive survey measuring demographic and clinical characteristics , HRQOL , disability , relapse rate , and the Diet Habits Question naire ( DHQ ) . Results Of 2469 participants with confirmed MS , 2087 ( 84.5 % ) provided complete data on their dietary habits ( DHQ total score ) . Multivariate regression models demonstrated that every 10-point increase on the DHQ total score was associated with nearly a six-point and five-point increase in physical and mental HRQOL , respectively , and 30.0 % reduced likelihood of a higher level of disability . After controlling for age and gender , and the other dietary covariates , ‘ healthy ’ consumption of fruit and vegetables and dietary fat predicted better quality of life and less likelihood of higher disability when compared to respondents with a ‘ poor ’ diet . For those with relapsing – remitting MS , the DHQ total significantly predicted a lower relapse rate and reduced odds of increasing disease activity , but the model fit was poor and the predicted change only marginal . Discussion This study supports significant associations of healthy dietary habits with better physical and mental HRQOL and a lower level of disability . Further research is urgently required to explore these associations including r and omized controlled trials of dietary modification for people with MS Seventy-five patients in London and Belfast with multiple sclerosis were given daily supplements of a vegetable oil mixture containing either linoleate or oleate for two years in a double-blind control trial . Relapses tended to be less frequent and were significantly less severe and of shorter duration in the linoleate-supplemented group than in those receiving the oleate mixture , but clear evidence that treatment affected the overall rate of clinical deterioration was not obtained Objective : Low vitamin D status has been associated with multiple sclerosis ( MS ) prevalence and risk , but the therapeutic potential of vitamin D in established MS has not been explored . Our aim was to assess the tolerability of high-dose oral vitamin D and its impact on biochemical , immunologic , and clinical outcomes in patients with MS prospect ively . Methods : An open-label r and omized prospect i ve controlled 52-week trial matched patients with MS for demographic and disease characteristics , with r and omization to treatment or control groups . Treatment patients received escalating vitamin D doses up to 40,000 IU/day over 28 weeks to raise serum 25-hydroxyvitamin D [ 25(OH)D ] rapidly and assess tolerability , followed by 10,000 IU/day ( 12 weeks ) , and further downtitrated to 0 IU/day . Calcium ( 1,200 mg/day ) was given throughout the trial . Primary endpoints were mean change in serum calcium at each vitamin D dose and a comparison of serum calcium between groups . Secondary endpoints included 25(OH)D and other biochemical measures , immunologic biomarkers , relapse events , and Exp and ed Disability Status Scale ( EDSS ) score . Results : Forty-nine patients ( 25 treatment , 24 control ) were enrolled [ mean age 40.5 years , EDSS 1.34 , and 25(OH)D 78 nmol/L ] . All calcium-related measures within and between groups were normal . Despite a mean peak 25(OH)D of 413nmol/L , no significant adverse events occurred . Although there may have been confounding variables in clinical outcomes , treatment group patients appeared to have fewer relapse events and a persistent reduction in T-cell proliferation compared to controls . Conclusions : High-dose vitamin D ( ∼10,000 IU/day ) in multiple sclerosis is safe , with evidence of immunomodulatory effects . Classification of evidence : This trial provides Class II evidence that high-dose vitamin D use for 52 weeks in patients with multiple sclerosis does not significantly increase serum calcium levels when compared to patients not on high-dose supplementation . The trial , however , lacked statistical precision and the design requirements to adequately assess changes in clinical disease measures ( relapses and Exp and ed Disability Status Scale scores ) , providing only Class level IV evidence for these outcomes The aim of this preliminary study was to evaluate the effect of low-dose oral vitamin D in combination with current disease-modifying therapy on the prevention of progression of relapsing-remitting multiple sclerosis ( RRMS ) . A phase II double-blind placebo-controlled r and omized clinical trial conducted between October 2007 and October 2008 included 50 patients with confirmed RRMS aged 25 to 57 years and normal serum 25-hydroxyvitamin D. They were r and omly allocated to receive 12 months of treatment with either escalating calcitriol doses up to 0.5 μg/day or placebo combined with disease-modifying therapy . Response to treatment was assessed at eight-week intervals . In both groups , the mean relapse rate decreased significantly ( P < 0.001 ) . In the 25 patients treated with placebo , the mean ( SD ) Exp and ed Disability Status Scale ( EDSS ) increased from 1.70 ( 1.21 ) at baseline to 1.94 ( 1.41 ) at the end of study period ( P < 0.01 ) . Average EDSS and relapse rate at the end of trial did not differ between groups . Adding low-dose vitamin D to routine disease-modifying therapy had no significant effect on the EDSS score or relapse rate . A larger phase III multicenter study of vitamin D in RRMS is warranted to more assess the efficacy of this intervention Objective To assess whether three novel interventions , formulated based on a systems medicine therapeutic concept , reduced disease activity in patients with relapsing – remitting multiple sclerosis ( MS ) who were either treated or not with disease-modifying treatment . Design A 30-month r and omised , double-blind , placebo-controlled , parallel design , phase II proof-of-concept clinical study . Setting s Cyprus Institute of Neurology and Genetics . Participants 80 participants were r and omised into four groups of 20 each . A total of 41 ( 51 % ) patients completed the 30-month trial . The eligibility criteria were an age of 18–65 ; a diagnosis of relapsing – remitting MS according to the McDonald criteria ; a score of 0.0–5.5 on the Exp and ed Disability Status Scale ( EDSS ) ; MRI showing lesions consistent with MS ; at least one documented clinical relapse and either receiving or not a disease-modifying treatment within the 24-month period before enrolment in the study . Patients were excluded because of a recent ( < 30 days ) relapse , prior immunosuppressant or monoclonal antibody therapy , pregnancy or nursing , other severe disease compromising organ function , progressive MS , history of recent drug or alcohol abuse , use of any additional food supplements , vitamins or any form of polyunsaturated fatty acids , and a history of severe allergic or anaphylactic reactions or known specific nutritional hypersensitivity . Interventions The first intervention ( A ) was composed of Ω-3 and Ω-6 polyunsaturated fatty acids at 1:1 wt/wt . Specifically , the Ω-3 fatty acids were docosahexaenoic acid and eicosapentaenoic acid at 3:1 wt/wt , and the Ω-6 fatty acids were linoleic acid and γ-linolenic acid at 2:1 wt/wt . This intervention also included minor quantities of other specific polyunsaturated , monounsaturated and saturated fatty acids as well as vitamin A and vitamin E ( α-tocopherol ) . The second intervention ( B , PLP10 ) was a combination of A and γ-tocopherol . The third intervention ( C ) was γ-tocopherol alone . The fourth group of 20 participants received placebo . The interventions were administered per os ( by mouth ) once daily , 30 min before dinner for 30 months . Main outcome measures The primary end point was the annualised relapse rate ( ARR ) of the three interventions versus the placebo at 2 years . The secondary end point was the time to confirmed disability progression at 2 years . Results A total of 41 ( 51 % ) patients completed the 30-month trial . Overall , for the per- protocol analysis of the 2-year primary end point , eight relapses were recorded in the PLP10 group ( n=10 ; 0.40 ARR ) versus 25 relapses in the placebo group ( n=12 ; 1.04 ARR ) , representing a 64 % adjusted relative rate reduction for the PLP10 group ( RRR 0.36 , 95 % CI 0.15 to 0.87 , p=0.024 ) . In a subgroup analysis that excluded patients on monoclonal antibody ( natalizumab ) treatment , the observed adjusted RRR became stronger ( 72 % ) over the 2 years ( RRR 0.28 , 95 % CI 0.10 to 0.79 , p=0.016 ) . The per- protocol analysis for the secondary outcome at 2 years , the time to disability progression , was significantly longer only for PLP10 . The cumulative probability of disability progression at 2 years was 10 % in the PLP10 group and 58 % in the placebo group ( unadjusted log-rank p=0.019 ) . In a subgroup analysis that excluded patients on natalizumab , the cumulative probability of progression was 10 % for the 10 patients in the PLP10 group and 70 % for the 12 patients in the placebo group , representing a relative 86 % decrease in the risk of the sustained progression of disability in the PLP10 group ( unadjusted log-rank p=0.006 ; adjusted HR , 0.11 ; 95 % CI 0.01 to 0.97 , p=0.047 ) . No adverse events were reported . Interventions A ( 10 patients ) and C ( 9 patients ) showed no significant efficacy . Conclusions In this small proof-of-concept , r and omised , double-blind clinical trial ; the PLP10 treatment significantly reduced
Output:
| A pilot test of our newly developed patient education program with 13 participants showed excellent comprehensibility and the MS-specific content was judged as very important .
Development and pilot-testing of an evidence -based patient education program on nutrition and MS is feasible .
Patient satisfaction with the program suffers from the lack of evidence . |
MS213591 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE Two million cataract extraction s are performed annually in the United States . The procedure is nearly always accompanied by implantation of a monofocal intraocular lens ( IOL ) , which corrects the patient 's distance vision . The authors ' objective was to measure visual function and quality -of-life outcomes associated with bilateral implantation of a multifocal IOL , which corrects distance and near vision , and to compare the outcomes with those of the st and ard therapy . DESIGN A prospect i ve , r and omized , double-masked , clinical trial was conducted at eight sites in the United States , seven sites in Germany , and one site in Austria . PARTICIPANTS Participants included 245 cataract patients , 127 of whom received the multifocal IOL bilaterally and 118 of whom received a monofocal IOL of nearly identical construction bilaterally . METHODS Clinical data included visual acuity ( VA ) , complications , and adverse events . Quality -of-life data were collected using a previously vali date d survey instrument at baseline , after first eye surgery , and after second eye surgery . RESULTS At 3 months after surgery , patients who had received multifocal IOLs had significantly better uncorrected and distance corrected binocular near VA compared with patients who had received monofocal IOLs ( mean uncorrected VA , 20/26 multifocal vs. 20/40 monofocal ; mean distance corrected VA , 20/28 multifocal vs. 20/45 monofocal ; P < 0.0001 ) . Additionally , 96 % of patients who had received multifocal IOLs and 65 % of patients who had received monofocal IOLs achieved both 20/40 and J3 ( Jaeger ) or better uncorrected , binocular distance and near visual acuities ( P < 0 . 0001 ) . Patients who had received multifocal IOLs were more likely than patients who had received monofocal IOLs to never wear glasses overall ( 32 % multifocal vs. 8 % monofocal ; P < 0.0001 ) . On a 4-point scale , patients who had received multifocal IOLs on average reported having between " a little bit " and " some " glare or halo , whereas patients who had received monofocal IOLs reported between " none " and " a little bit " of glare or halo ( 1.57 vs. 0.43 ; P < 0.001 ) . Patients who had received multifocal IOLs rated their vision without glasses better overall at near and at intermediate distances ( P < or = 0.002 ) and demonstrated better visual function for near tasks and social activities . CONCLUSIONS Cataract patients who received multifocal IOLs at time of surgery obtained better uncorrected and distance corrected near VA and reported better overall vision , less limitation in visual function , less spectacle dependency , and more glare or halo than those who received traditional monofocal IOLs Aims To evaluate the functional effect of bilateral implantation of two different multifocal intraocular lenses ( IOL ) compared with the st and ard monofocal IOL . Methods Sixty-nine patients were recruited into a prospect i ve , double-masked , r and omised , controlled trial at a single hospital in the United Kingdom . Sixty completed follow-up ; 16 implanted with monofocal IOLs , 29 with AMO ’ ARRAY ’ multifocal IOLs and 15 with Storz ’ TRUEVISTA ’ bifocal IOLs . Phacoemulsification and IOL implantation was performed to a st and ardised technique in both eyes within a 2-month period . The main outcome measures were distance and near visual acuity , depth of field and vali date d assessment of subjective function ( TyPE question naire ) . Results Unaided distance acuity was good , and equivalent across the three groups . Corrected distance acuity was significantly lower in the bifocal group . Patients with multifocal and bifocal IOLs could read smaller absolute print size than those in the monofocal group ( P = 0.05 ) , but at a closer reading distance such that mean unaided near acuity was equal in the three groups . Corrected near acuity was significantly higher in the monofocal control group ( P < 0.05 ) . Depth of field was increased in multifocal ( P = 0.06 ) and bifocal ( P = 0.004 ) groups . Overall visual satisfaction was equal in the three groups , while near visual satisfaction was higher in the multifocal group than the monofocal ( P = 0.04 ) . Spectacle independence was not seen in the monofocal group , but was achieved in 28 % of multifocal IOL patients and 33 % of bifocal patients ( P < 0.001 ) . Adverse symptoms such as glare and haloes were significantly more bothersome with multifocal ( not bifocal ) IOLs than monofocals ( P = 0.01 ) . Conclusions Multifocal and bifocal IOLs improved unaided near vision performance , with around one in three patients becoming spectacle-independent . The main adverse effect was an increased incidence of subjective glare and haloes in the multifocal IOL group Purpose : To compare contrast sensitivity ( CS ) after implantation of a diffractive bifocal intraocular lens ( IOL ) and a monofocal IOL of similar design . Setting : Seven European centers . Methods : In this r and omized , prospect i ve study , CS was tested 5 months after cataract and IOL implantation surgery in 115 patients with a diffractive bifocal IOL and 106 patients with a monofocal IOL . It was also tested in a subgroup of 38 patients who had bilateral implantation of a diffractive bifocal IOL . Contrast sensitivity was tested using the Vision Contrast Test System ( VCTS ) . Results : In patients with a best corrected visual acuity ( BCVA ) of 1.0 or better , the CS at all spatial frequencies ( 1.5 to 18 cycles/degree ) , both at distance and near , was slightly lower in the bifocal IOL group than in the monofocal group . Mean values were within the normal range . In patients with a BCVA of less than 1.0 , the CS was lower and the difference between the bifocal and monofocal groups was less . In patients with bilateral bifocal IOLs , CS was better when tested bilaterally than when testing the better eye alone . Pupil size affected the results to a small degree . Contrast sensitivity appeared to improve over time after implantation of a diffractive bifocal IOL . Conclusions : In patients with cataract and no other eye pathology , the diffractive bifocal IOL will slightly reduce the CS at all spatial frequencies . In those with reduced visual acuity after cataract surgery , CS will be reduced accordingly . In this situation , the reduction from the diffractive bifocal optic would be minor Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more PURPOSE : To compare changes in reading performance parameters after implantation of 4 multifocal intraocular lens ( IOL ) models and a monofocal IOL . SETTING : Department of Ophthalmology , Paracelsus Medical University , Salzburg , Austria . DESIGN : Prospect i ve r and omized controlled clinical trial . METHODS : Patients with bilateral cataract without additional ocular pathology were scheduled for bilateral implantation of Acri . Smart 48S monofocal , Acrysof Restor SN6AD3 apodized multifocal , AT LISA 366D diffractive multifocal , Tecnis ZMA00 diffractive multifocal , or Rezoom refractive multifocal IOLs . Bilateral corrected and uncorrected reading acuity , reading distance , mean and maximum reading speeds , and smallest log‐scaled print size of a Radner reading chart were evaluated under bright lighting conditions ( 500 lux ) using the Salzburg Reading Desk . Pupil size was not measured throughout the trial . The minimum follow‐up was 12 months . RESULTS : The diffractive multifocal groups had significantly better uncorrected reading acuity and uncorrected smallest print size than the monofocal and refractive multifocal groups 1 , 6 , and 12 months postoperatively . The diffractive IOL groups had comparable uncorrected reading distance of approximately 32 cm , which was larger in the monofocal group ( 38.9 ± 8.4 cm ) and refractive multifocal group ( 37.1 ± 7.3 cm ) at the last visit . Patients with diffractive IOLs could read print sizes of approximately 0.74 to 0.87 mm , which was much better than in the monofocal and refractive multifocal groups . The diffractive AT LISA IOL provided the best reading speed values ( mean and maximum , corrected and uncorrected ) . CONCLUSION : Multifocal IOLs with a diffractive component provided good reading performance that was significantly better than that obtained with a refractive multifocal or monofocal IOL . Financial Disclosure : Drs . Grabner and Dexl were patent owners of the Salzburg Reading Desk technology ( now owned by SRD‐Vision , LLC ) . No other author has a financial or proprietary interest in any material or method mentioned PURPOSE To compare new-generation multifocal intraocular lenses ( IOLs ) with monofocal IOLs . DESIGN R and omized prospect i ve clinical trial . PARTICIPANTS Sixty-two consecutive patients with cataract , seen between January of 2005 and January of 2006 at the Department of Ophthalmology of Palermo University Hospital in Italy , were bilaterally implanted with monofocal ( AR 40 , Advanced Medical Optics [ AMO ] , Santa Ana , CA ; 15 patients ) , multifocal refractive ( Array SA40N , AMO ; 16 patients ) , multifocal refractive ( ReZoom , AMO ; 15 patients ) , or multifocal diffractive pupil-independent ( Tecnis ZM900 , AMO ; 16 patients ) IOLs . INTERVENTION Bimanual phacoemulsification . MAIN OUTCOME MEASURES Primary outcomes were far , near , and intermediate visual acuity of the 4 IOL-implanted groups . Secondary outcomes were defocusing curves , contrast sensitivity , patients ' quality of life ( 7-item visual function question naire [ VF-7 ] , halos and glare presence , overall satisfaction ) , and spectacle independence . Snellen visual acuity was measured as uncorrected visual acuity ( UCVA ) , best corrected visual acuity ( BCVA ) , uncorrected near visual acuity ( UCNVA ) , best distance corrected near visual acuity ( BDCNVA ) , best corrected near visual acuity ( BCNVA ) , uncorrected intermediate visual acuity ( UCIVA ) , and best distance corrected intermediate visual acuity ( BDCIVA ) . RESULTS UCNVA was 20/50 in the monofocal IOL group , compared with 20/32 or better in the multifocal IOL groups ( P<0.0005 ) . The monofocal IOL group exhibited a lower BDCNVA than the multifocal IOL groups ( P<0.0005 ) . The diffractive multifocal IOL group performed better than either refractive group ( P = 0.007 ) . UCIVA was significantly different ( P = 0.001 ) among the groups : monofocal ( AR 40 ) 20/32 ; multifocal refractive ( Array SA40N ) 20/30 ; multifocal refractive ( ReZoom ) 20/25 ; and multifocal diffractive ( Tecnis ZM900 ) 20/30 . Defocusing curves with -3.00 diopter lens exhibited a better trend in the diffractive group . The refractive multifocal IOL groups exhibited lower contrast sensitivities at 3 cycles/degree ( P = 0.038 ) . The VF-7 mean score was significantly lower in the monofocal than the multifocal IOL groups ( P = 0.002 ) . Night halos were more common in the refractive groups ( P<0.01 ) . Spectacle independence was 20 % in the monofocal IOL group , 43.7 % and 53.3 % in the refractive multifocal IOL groups , and 87.5 % in the diffractive multifocal IOL group ( P<0.05 ) . CONCLUSIONS Multifocal IOLs provide a greater depth of focus and higher patient satisfaction , and make intermediate and near visual tasks easier than do monofocal lenses . New-generation , diffractive , pupil-independent multifocal IOLs provide better near vision , equivalent intermediate vision , less unwanted photic phenomena , and greater spectacle independence than either monofocal or refractive multifocal IOLs OBJECTIVE To compare the binocular near vision performance in patients implanted with the 1CU accommodating intraocular lens ( IOL ) with a multifocal and monofocal IOL . DESIGN Prospect i ve , r and omized , double-masked clinical trial . PARTICIPANTS Ninety patients presenting for cataract surgery to the Department of Ophthalmology , Hillingdon Hospital were r and omized to receive the 1CU accommodative IOL , a multifocal IOL , or a monofocal IOL ( control group ) . METHODS Patients underwent bilateral sequential phacoemulsification with implantation of 1 of the 3 IOL types and were assessed at 3 and 18 months after second-eye surgery . MAIN OUTCOME MEASURES Logarithm of the minimum angle of resolution distance and near visual acuities ( VAs ) ( unaided and distance corrected ) , contrast sensitivity , and accommodative
Output:
| There was no difference in pooled estimates of corrected or uncorrected distance vision between multifocal and st and ard IOLs .
Newer multifocal lenses had statistically significantly better outcomes than older diffractive lenses or refractive lenses , when compared to monofocal IOLs , in near vision , quality of vision , and risk of halos .
Conclusions Multifocal IOLs compared to st and ard IOLs or monovision result in better uncorrected near vision and a higher proportion of patients who achieve spectacle independence , but greater risk of unwanted visual phenomena .
Newer diffractive lenses may be better than refractive lenses in near vision and quality of vision outcomes , with less risk of halos than older diffractive lenses and refractive lenses . ( |
MS213592 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : In Italy , cervical cancer screening programmes actively invite women aged 25–64 years . Programmes are hindered by low participation . Methods : A sample of non-responder women aged 35–64 years , belonging to three different programmes ( in Rome , Florence and Teramo ) , was r and omly split into four arms : two control groups received st and ard recall letters to perform either Pap-test ( first group ) or human papillomavirus ( HPV ) test ( second group ) at the clinic . A third arm was sent letters offering a self- sample r for HPV testing , to be requested by phone , whereas a fourth group was directly sent the self- sample rs home . Results : Compliance with st and ard recall was 13.9 % ( N619 ) . Offering HPV test at the clinic had a nonsignificant effect on compliance ( N616 , relative risk (RR)=1.08 ; 95 % CI=0.82–1.41 ) . Self- sample r at request had the poorest performance , 8.7 % ( N622 , RR=0.62 ; 95 % CI=0.45–0.86 ) , whereas direct mailing of the self- sample r registered the highest compliance : 19.6 % ( N616 , RR=1.41 ; 95 % CI=1.10–1.82 ) . This effect on compliance was observed only in urban areas , Florence and Rome ( N438 , RR=1.69 ; 95 % CI=1.24–2.30 ) , but not in Abruzzo ( N178 , RR=0.95 ; 95 % CI=0.61–1.50 ) , a prevalently rural area . Conclusions : Mailing self- sample rs to non-responders may increase compliance as compared with delivering st and ard recall letters . Nevertheless , effectiveness is context specific and the strategy costs should be carefully considered Cervical cancer is more common in the Somali immigrant population than the general population in the United States ( US ) . There are low rates of cervical cancer screening among Somali women . This study compares cervical cancer screening test completion rates for a home human papilloma virus ( HPV ) test and st and ard clinic Pap test . Sixty‐three Somali immigrant women aged 30–70 years who had not undergone cervical cancer screening within the past 3 years were r and omly assigned to a home HPV test group ( intervention ) or a clinic Pap test group ( control ) . Test completion rates were measured at 3 months . Univariate and multivariate logistic regression models were used to explore factors associated with test completion ( intention‐to‐treat analysis ) . Participants in the HPV test group were 14 times more likely to complete the test compared to those in the Pap test group ( P = 0.0002 ) . Women who reported having friends/family members to talk about cancer screening were approximately three times more likely to complete any screening test than those who did not ( P = 0.127 ) and participants who reported residing in the US longer were more likely to complete a screening test ( P = 0.011 ) . Future research should explore the potential of using the home‐based HPV test kits as an initial approach to cervical cancer screening . Impact : The use of a self‐sampling HPV kit has the potential to increase cervical cancer screening in under‐served communities in the US Background : A r and omised trial to ascertain whether women who do not attend for cervical screening are more likely to respond to the opportunity to collect a self- sample for human papillomavirus ( HPV ) testing , or to a further invitation to attend for cervical screening . Methods : The study was carried out in a Primary Care Trust ( PCT ) in London between June 2009 and December 2009 . In total , 3000 women were r and omly selected from persistent non-responders ( i.e. , who had not responded to at least two invitations to attend for screening ) . The women were r and omised on a 1 : 1 basis to either receive an HPV self-sampling kit or a further invitation to attend for cervical cytology . The main outcome measures were ( 1 ) percentage of women attending for cervical cytology compared with those returning a self- sample HPV test or attending for cytology subsequent to receiving the kit and ( 2 ) percentage of those testing positive for HPV who attended further investigation . Results : The total response in the self-sampling group for screening was 10.2 % . Of the 1500 women in the control group sent a further invitation for cervical screening , 4.5 % attended for cytology screening . This difference is highly statistically significant ( P<0.0001 ) . Of the 8 women who tested positive for HPV , 7 attended for a cervical smear and had a concurrent colposcopy . Three of these ( 43 % ) had high- grade disease ( defined as CIN 2 + ) , with one found to have an invasive cancer ( stage 1b ) and one CIN 3 . Conclusions : The value of this intervention relies on the detection of high- grade CIN and early stage cancer with a good prognosis . The relatively high yield of abnormalities found is consistent with that expected among a hard to reach and relatively high-risk group of women . Our study suggests that self-sampling could increase participation among non-responders in Engl and , but further work is needed to ascertain whether the low response rate seen here is likely to be representative of the rest of the country . Other studies are needed to investigate the response to self-sampling in different demographic and geographic setting Objectives The incidence of cervical cancer is up to 20-fold higher among First Nations women in Canada than the general population , probably due to lower participation in screening . Offering human papillomavirus ( HPV ) self-sampling in place of Papanicolaou ( Pap ) testing may eventually increase screening participation and reduce cervical cancer rates in this population . Design A community-r and omised controlled screening trial . Setting First Nations communities in Northwest Ontario , Canada . Participants Women aged between 25 and 69 , living in Robinson Superior Treaty First Nations . The community was the unit of r and omisation . Interventions Women were asked to complete a question naire and have screening by HPV self-sampling ( arm A ) or Pap testing ( arm B ) . Primary outcome measures The number of women who participated in cervical screening . R and omisation Community clusters were r and omised to include approximately equivalent numbers of women in each arm . Results 6 communities were r and omised to arm A and 5 to arm B. One community withdrew , leaving 5 communities in each group ( 834 eligible women ) . Participation was < 25 % . Using clustered intention-to-treat ( ITT ) analysis , initial and cumulative averaged uptakes in arm A were 1.4-fold ( 20 % vs 14.3 % , p=0.628 ) and 1.3-fold ( 20.6 % vs 16 % , p=0.694 ) higher compared to arm B , respectively . Corresponding per protocol ( PP ) analysis indicates 2.2-fold ( 22.9 % vs 10.6 % , p=0.305 ) and 1.6-fold ( 22.9 % vs 14.1 % , p=0.448 ) higher uptakes in arm A compared to arm B. Screening uptake varied between communities ( range 0–62.1 % ) . Among women who completed a question naire ( 18.3 % in arm A , 21.7 % in arm B ) , the screening uptake was 1.8-fold ( ITT ; p=0.1132 ) or 3-fold ( PP ; p<0.01 ) higher in arm A versus arm B. Conclusions Pap and HPV self-sampling were compared in a marginalised , Canadian population . Results indicated a preference for self-sampling . More research on how to reach underscreened Indigenous women is necessary . Trial registration number IS RCT N84617261 Background Cervical cancer screening participation remains insufficient in most countries . Our aim was to evaluate whether offering a HPV self-sampling kit , either mailed directly to the woman ’s home or using timely opt-in procedures for ordering the kit , increased screening participation compared with a st and ard second reminder . Methods In this r and omized , controlled effectiveness trial , 9791 Danish women aged 30–64 who were due to receive the second reminder were equally r and omized to either : 1 ) direct mailing of a second reminder and a self-sampling kit ( directly mailed group ) ; 2 ) mailing of a second reminder that offered a self-sampling kit to be ordered by e-mail , text message , phone , or webpage ( opt-in group ) ; or 3 ) mailing of a second reminder to attend regular cytology screening ( control group ) . In an intention-to-treat analysis , we estimated the participation rate at 180 days post intervention , by returning a self- sample or attending regular cytology screening . We calculated the proportion of women with a positive HPV self- sample who attended for cervical cytology triage at the general practitioner within 90 days . Results Participation was significantly higher in the directly mailed group ( 38.0 % ) and in the opt-in group ( 30.9 % ) than in the control group ( 25.2 % ) ( participation difference ( PD ) : 12.8 % , 95 % CI : 10.6–15.0 % and PD : 5.7 % , 95 % CI : 3.5–7.9 % , respectively ) . Within 90 days , 107 women ( 90.7 % , 95 % CI : 83.9–95.3 % ) with a HPV-positive self- sample attended follow-up . Conclusions Offering the opportunity of HPV self-sampling as an alternative to regular cytology screening increased participation ; the direct mailing strategy was the most effective invitation strategy . A high compliance with follow-up was seen . Trial registration Current Controlled Trials NCT02680262 . Registered 10 February 2016 Background Ethnic minority women are at increased risk of cervical cancer . Self-sampling for high-risk human papillomavirus ( HPV ) is a promising approach to increase cervical screening among hard-to-reach population s. Objective To compare a community health worker (CHW)-led HPV self-sampling intervention with st and ard cervical cancer screening approaches . Design A 26-week single-blind r and omized pragmatic clinical trial . Participants From October 6 , 2011 to July 7 , 2014 , a total of 601 Black , Haitian , and Hispanic women aged 30–65 years in need of cervical cancer screening were recruited , 479 of whom completed study follow-up . Interventions Participants were r and omized into three groups : ( 1 ) outreach by CHWs and provision of culturally tailored cervical cancer screening information ( outreach ) , ( 2 ) individualized CHW-led education and navigation to local health care facilities for Pap smear ( navigation ) , or ( 3 ) individualized CHW-led education with a choice of HPV self-sampling or CHW-facilitated navigation to Pap smear ( self-swab option).Main Measures The proportion of women in each group whom self-reported completion of cervical cancer screening . Women lost to follow-up were considered as not having been screened . Key Results Of the 601 women enrolled , 355 ( 59 % ) were Hispanic , 210 ( 35 % ) were Haitian , and 36 ( 6 % ) were non-Haitian Black . In intent-to-treat analyses , 160 of 207 ( 77 % ) of women in the self-swab option group completed cervical cancer screening versus 57 of 182 ( 31 % ) in the outreach group ( aOR 95 % CI , p < 0.01 ) and 90 of 212 ( 43 % ) in the navigation group ( aOR CI , p = 0.02 ) . Conclusions As compared to more traditional approaches , CHW-facilitated HPV self-sampling led to increased cervical cancer screening among ethnic minority women in South Florida . Trial Registration Clinical Trials.gov Identifier : We conducted a r and omized , controlled trial to evaluate different strategies of offering an HPV-self sampling program , and compared this with two control groups . All total of 35,354 women who did not participate in the Flemish cancer screening program were included in the study : 9,118 received a HPV self- collection brush ( RIATOL qPCR HPV genotyping test ( qPCR [ E6/E7 ] ) ; 9,098 were offered the opportunity to order an HPV-selfsampling brush , 8,830 received the recall letter ; 8,849 received no intervention . Within 12 months after the mailing , 18.7 % of the women who had received the brush , participated by returning a self- sample sample , while 10.6 % women allocated to the opt- in group did so . 10.5 % women who received the st and ard recall letter , had a PAP smear taken within a period of 12 months ; while 8 % women did so without receiving an intervention at all . Participation in postmenopausal women was higher than in women younger than 50 in both self-sampling arms . Screening by means of the self- sample kit increased by age , contradictory when screening is performed by a PAP smear . Of those testing hrHPV positive ( 9.5 % ) , 88.9 % attended for follow up cytology . The mean DNA concentration , found in the self- sample r , decreased by age , causing a higher number of inconclusive results . Our results support the efficacy of a self-sampling strategy to increase participation in
Output:
| Conclusion A growing evidence base , mainly from high-income countries and with significant heterogeneity , suggests HPV self-sampling can increase cervical cancer screening uptake compared with st and ard of care , with a marginal effect on linkage to clinical assessment /treatment . |
MS213593 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Extrication and spinal immobilization in the trauma patient with unknown injuries is a common practice of emergency medical services . High-speed crashes occurring in open-wheel racing seldom result in extrication or spinal immobilization . OBJECTIVES To evaluate the safety of self-extrication in IndyCar ® ( Indianapolis , IN ) by comparing drivers self extricated with full spinal immobilization and subsequent radiation exposure . METHODS A retrospective review of prospect ively collected de-identified IndyCar ® crash and drivers ' medical records was performed at treating Level I trauma centers . One hundred thirty-five crash incidents involving drivers evaluated by a medical team were included . Any driver with severe multiple trauma was excluded due to distracting injuries . Drivers underwent st and ard protocol for postcrash injury . Diagnostic and treatment outcomes including spinal and neurologic injury , need for surgery , and radiation exposure were collected for review . RESULTS Self-extrication occurred in 121 ( 90 % ) crashes , and overall cumulative radiation exposure ranged from 100 to 250 mSv , or 0.82 - 2.06 mSv per driver . Extrication with full spinal immobilization occurred in 14 ( 10 % ) drivers , with overall cumulative radiation exposure ranging from 140 to 350 mSv , or 10 - 25 mSv per driver . A total of 29 injuries were identified , nine of which ( 31 % ) were spinal . In these , six were emergency medical services extricated and three self extricated . None were unstable spinal fractures result ing in surgical care , surgical disease , or neurologic deficit . CONCLUSION In our IndyCar ® racing experience , a protocol -led self-extrication system result ed in neither a mismanagement of an unstable spinal fracture nor neurological deficit , and reduced radiation exposure BACKGROUND Intoxication often prevents clinical clearance of the cervical spine ( Csp ) after trauma leading to prolonged immobilization even with a normal computed tomography ( CT ) scan . We evaluated the accuracy of CT at detecting clinical ly significant Csp injury , and surveyed participants on related opinions and practice . METHODS A prospect i ve multicenter study ( 2013–2015 ) at 17 centers . All adult blunt trauma patients underwent structured clinical examination and imaging including a Csp CT , with follow-up thru discharge . alcohol- and drug-intoxicated patients ( TOX+ ) were identified by serum and /or urine testing . Primary outcomes included the incidence and type of Csp injuries , the accuracy of CT scan , and the impact of TOX+ on the time to Csp clearance . A 36-item survey querying local protocol s , practice s , and opinions in the TOX+ population was administered . RESULTS Ten thous and one hundred ninety-one patients were prospect ively enrolled and underwent CT Csp during the initial trauma evaluation . The majority were men ( 67 % ) , had vehicular trauma or falls ( 83 % ) , with mean age of 48 years , and mean Injury Severity Score ( ISS ) of 11 . The overall incidence of Csp injury was 10.6 % . TOX+ comprised 30 % of the cohort ( 19 % EtOH only , 6 % drug only , and 5 % both ) . TOX+ were significantly younger ( 41 years vs. 51 years ; p < 0.01 ) but with similar mean Injury Severity Score ( 11 ) and Glasgow Coma Scale score ( 13 ) . The TOX+ cohort had a lower incidence of Csp injury versus nonintoxicated ( 8.4 % vs. 11.5 % ; p < 0.01 ) . In the TOX+ group , CT had a sensitivity of 94 % , specificity of 99.5 % , and negative predictive value ( NPV ) of 99.5 % for all Csp injuries . For clinical ly significant injuries , the NPV was 99.9 % , and there were no unstable Csp injuries missed by CT ( NPV , 100 % ) . When CT Csp was negative , TOX+ led to longer immobilization versus sober patients ( mean , 8 hours vs. 2 hours ; p < 0.01 ) , and prolonged immobilization ( > 12 hrs ) in 25 % . The survey showed marked variations in protocol s , definitions , and Csp clearance practice s among participating centers , although 100 % indicated willingness to change practice based on these data . CONCLUSION For intoxicated patients undergoing Csp imaging , CT scan was highly accurate and reliable for identifying clinical ly significant spine injuries , and had a 100 % NPV for identifying unstable injuries . CT-based clearance in TOX+ patients appears safe and may avoid unnecessary prolonged immobilization . There was wide disparity in practice s , definitions , and opinions among the participating centers . LEVEL OF EVIDENCE Diagnostic tests or criteria , level II OBJECTIVES To compare the incidences and severities of pain experienced by healthy volunteers undergoing spinal immobilization in the neutral position with and without occipital padding . To compare the incidence of pain when immobilized in the neutral position with the incidence in a nonneutral position . METHODS Thirty-nine healthy volunteers over the age of 18 years who had no acute pain or illness , were not pregnant , and had no history of back problems or surgery voluntarily participated in a prospect i ve , r and omized , crossover study conducted in a clinical laboratory setting . Appropriately sized rigid cervical collars were applied to the subjects , who were then immobilized on wooden backboards with their cervical spines maintained in the neutral position using towels ( padded ) or plywood ( unpadded ) under their occiputs . The subjects were secured to the board with straps , soft head blocks , and tape for 15 minutes to simulate a typical ambulance transport time . The straps , head blocks , and tape were removed , and the subjects remained on the board for an additional 45 minutes to simulate a typical emergency department experience . The subjects were then asked to identify the location(s ) of any pain on anterior and posterior body outlines and to indicate the corresponding severity of pain on a 10-cm visual analog scale . The subjects were also asked questions about movement , respiratory symptoms , and strap discomfort in an attempt to distract them from the true focus of the study ( i.e. , pain ) . A similar survey was given to each participant to complete 24 hours later . The same subjects were immobilized with the alternate occipital material a minimum of two weeks later utilizing the same procedure . They again completed both surveys . RESULTS Pain was reported by 76.9 % of the subjects following removal from the backboard for the unpadded trial and 69.2 % of the subjects following the padded trial ( p < 0.45 ) . Twenty-three percent ( 23.1 % ) of the subjects reported neck pain after the unpadded trial , while 38.5 % reported neck pain after the padded trial ( p < 0.07 ) . Occipital pain was reported by 35.9 % in the unpadded trial and 25.6 % in the padded trial ( p < 0.29 ) . Twenty-four hours later , pain was reported by 17.9 % of the subjects following the unpadded trial and 23.1 % of the subjects following the padded trial ( p < 0.63 ) . Eight percent ( 7.7 % ) reported neck pain 24 hours after the and unpadded trial and 12.8 % after the padded trial ( p < 0.5 ) . Occipital pain was reported by 7.7 % of the subjects 24 hours after the unpadded trial and 2.6 % after the padded trial ( p < 0.63 ) . This study had a power of 0.90 to detect a difference of 30 % between the trials . The authors found a significantly lower incidence of pain ( p < 0.01 ) and occipital pain ( p < 0.01 ) in their unpadded trial compared with that reported by Chan et al. , who used neither padding nor neutral positioning to immobilize subjects . CONCLUSIONS Pain is frequently reported by healthy volunteers following spinal immobilization . Occipital padding does not appear to significantly decrease the incidence or severity of pain . Alignment of the cervical spine in the neutral position may reduce the incidence of pain , but further studies should be conducted to substantiate this observation INTRODUCTION Traditional EMS teaching identifies mechanism of injury as an important predictor of spinal injury . Clinical criteria to select patients for immobilization are being studied in Michigan and have been implemented in Maine . Maine requires automatic immobilization of patients with " a positive mechanism " clearly capable of producing spinal injury . OBJECTIVE To determine whether mechanism of injury affects the ability of clinical criteria to identify patients with spinal injury . METHODS In this multicenter prospect i ve cohort study , EMS personnel completed a check-off data sheet for prehospital spine-immobilized patients . Data included mechanism of injury and yes/no determinations of the clinical criteria : altered mental status , neurologic deficit , evidence of intoxication , spinal pain or tenderness , and suspected extremity fracture . Hospital outcome data included confirmation of spinal injury and treatment required . Mechanisms of injury were tabulated and rates of spinal injury for each mechanism were calculated . The patients were divided into three different high-risk and low-risk groups . RESULTS Data were collected for 6,500 patients . There were 209 ( 3.2 % ) patients with spinal injuries identified . There were 1,058 patients with 100 ( 9.4 % ) injuries in the first high-risk mechanism group , and 5,423 patients with 109 ( 2 % ) injuries in the first low-risk group . Criteria identified 97 of 100 ( 97 % ) injuries in the high-risk group and 102 of 109 ( 94 % ) in the low-risk group . Two additional data divisions yielded identical results . CONCLUSION Mechanism of injury does not affect the ability of clinical criteria to predict spinal injury in this population BACKGROUND A distracting injury m and ates cervical spine ( c-spine ) imaging in the evaluable blunt trauma patient who demonstrates no pain or tenderness over the c-spine . The purpose of this study was to examine which distracting injuries can negatively affect the sensitivity of the st and ard clinical examination of the c-spine . METHODS This is a prospect i ve observational study conducted at a Level I Trauma Center from January 1 , 2008 , to December 31 , 2009 . After institutional review board approval , all evaluable ( Glasgow Coma Scale score ≥13 ) blunt trauma patients older than 16 years sustaining a c-spine injury were enrolled . A distracting injury was defined as any immediately evident bony or soft tissue injury or a complaint of non-c-spine pain whether or not an actual injury was subsequently diagnosed . Information regarding the initial clinical examination and the presence of a distracting injury was collected from the senior resident or attending trauma surgeon involved in the initial management . RESULTS During the study period , 101 evaluable patients sustained a c-spine injury . Distracting injuries were present in 88 patients ( 87.1 % ) . The most common was rib fracture ( 21.6 % ) , followed by lower extremity fracture ( 20.5 % ) and upper extremity fracture ( 12.5 % ) . Only four ( 4.0 % ) patients had no pain or tenderness on the initial examination of the c-spine . All four patients had bruising and tenderness to the upper anterior chest . None of these four patients developed neurologic sequelae or required a surgical stabilization or immobilization . CONCLUSION C-spine imaging may not be required in the evaluable blunt trauma patient despite distracting injuries in any body regions that do not involve the upper chest . Further definition of distracting injuries is m and ated to avoid unnecessary utilization of re sources and to reduce the imaging burden associated with the evaluation of the c-spine OBJECTIVE For thirty years , emergency medical services agencies have emphasized limiting spinal motion during transport of the trauma patient to the emergency department . The long spine board ( LSB ) has been the mainstay of spinal motion restriction practice s , despite the paucity of data to support its use . The purpose of this study was to determine reduction in lateral motion afforded by the LSB in comparison to the stretcher mattress alone . METHODS This was a r and omized controlled crossover trial where healthy volunteer subjects were r and omly assigned to either LSB or stretcher mattress only . All subjects were fitted with a rigid cervical collar , secured to the assigned device ( including foam head blocks ) , and driven on a closed course with prescribed turns at a low speed ( < 20 mph ) . Upon completion , the subjects were then secured to the other device and the course was repeated . Each subject was fitted with 3 graduated-paper disks ( head , chest , hip ) . Lasers were affixed to a scaffold attached to the stretcher bridging over the patient and aim ed at the center of the concentric graduations on the disks . During transport , the degree of lateral movement was recorded during each turn . Significance was determined by t test . RESULTS In both groups , the head demonstrated the least motion with 0.46±0.4-cm mattress and 0.97±0.7-cm LSB ( P≤ .0001 ) . The chest and hip had lateral movement with chest 1.22±0.9-cm mattress and 2.22±1.4-cm LSB ( P≤ .0001 ) , and the hip 1.20±0.9-cm mattress and 1.88±1.2-cm LSB ( P≤ .0001 ) , respectively . In addition , lateral movement had a significant
Output:
| This process yielded five main recommendations : A strong recommendation against spinal stabilisation of patients with isolated penetrating trauma ; a weak recommendation against the prehospital use of a rigid cervical collar and a hard backboard for ABCDE-stable patients ; and a weak recommendation for the use of a vacuum mattress for patient transportation . |
MS213594 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To compare the efficacy of aquatic exercise and a l and -based exercise programme vs control in patients with knee osteoarthritis . METHODS Primary outcome was change in pain , and in addition Knee Injury and Osteoarthritis Outcome Score question naire ( KOOS ) . St and ing balance and strength was also measured after and at 3-month follow-up . Seventy-nine patients ( 62 women ) , with a mean age of 68 years ( age range 40 - 89 years ) were r and omized to aquatic exercise ( n = 27 ) , l and -based exercise ( n = 25 ) or control ( n = 27 ) . RESULTS No effect was observed immediately after exercise cessation ( 8 weeks ) . At 3-month follow-up a reduction in pain was observed only in the l and -based exercise group compared with control ( -8.1 mm , ( 95 % confidence interval -15.4 to -0.4 ; p = 0.039 ) , but no differences between groups were observed for KOOS ; and no improvement following aquatic exercise . Eleven patients reported adverse events ( i.e. discomfort ) in l and -based exercise , while only 3 reported adverse events in the aquatic exercise . CONCLUSION Only l and -based exercise showed some improvement in pain and muscle strength compared with the control group , while no clinical benefits were detectable after aquatic exercise compared with the control group . However , aquatic exercise has significantly less adverse effects compared with a l and -based programme OBJECTIVE To conduct a preliminary investigation of the effects on floatation spa therapy on quality of life in patients with osteoarthritis to see if controlled trials are warranted . DESIGN Uncontrolled clinical trial . SETTING Private floatation spa therapy centre . PATIENTS Fourteen patients with chronic osteoarthritis of the weight-bearing joints , of whom four dropped out . INTERVENTION Six weekly sessions of floatation spa therapy . OUTCOME MEASURES SF36 , AIMS 2 and MYMOP quality -of-life question naires . MAIN RESULTS All patients improved . Differences between baseline and discharge scores showed statistically significant improvement for MYMOP , but not AIMS 2 or SF-36 . CONCLUSIONS Controlled trials of floatation spa therapy for patients with osteoarthritis are warranted BACKGROUND Balneotherapy , traditionally administered during a continuous stay at the Dead Sea area , has been shown to be effective for patients suffering from knee osteoarthritis . OBJECTIVES To evaluate the effectiveness of an intermittent regimen of balneotherapy at the Dead Sea for patients with knee osteoarthritis . METHODS Forty-four patients with knee osteoarthritis were included in a prospect i ve r and omized single-blind controlled study . The patients were divided into two groups : a treatment group ( n=24 ) , which were treated twice weekly for 6 consecutive weeks in a sulfur pool heated to 35 - 36 degrees C , and a control group ( n=20 ) treated in a Jacuzzi filled with tap water heated to 35 - 36 degrees C. Participants were assessed by the Lequesne index of osteoarthritis severity , the WOMAC index , the SF-36 quality of health question naire , VAS scales for pain ( completed by patients and physicians ) , and physical examination . RESULTS A statistically significant improvement , lasting up to 6 months , was observed in the treatment group for most of the clinical parameters . In the control group the only improvements were in the SF-36 bodily pain scale at 6 months , the Lequesne index at 1 month and the WOMAC pain score at the end of the treatment period . Although the patients in the control group had milder disease , the difference between the two groups was not statistically significant . CONCLUSIONS Intermittent balneotherapy appears to be effective for patients with knee osteoarthritis Objectives .To estimate cost and outcomes of the Arthritis Foundation aquatic exercise classes from the societal perspective . Design .R and omized trial of 20-week aquatic classes . Cost per quality -adjusted life year ( QALY ) gained was estimated using trial data . Sample size was based on 80 % power to reject the null hypothesis that the cost/QALY gained would not exceed $ 50,000 . Subjects and Methods . Recruited 249 adults from Washington State aged 55 to 75 with a doctor-confirmed diagnosis of osteoarthritis to participate in aquatic classes . The Quality of Well-Being Scale ( QWB ) and Current Health Desirability Rating ( CHDR ) were used for economic evaluation , supplemented by the arthritis-specific Health Assessment Question naire ( HAQ ) , Center for Epidemiologic Studies -Depression Scale ( CES-D ) , and Perceived Quality of Life Scale ( PQOL ) collected at baseline and postclass . Outcome results applied to life expectancy tables were used to estimate QALYs . Use of health care facilities was assessed from diaries/ question naires and Medicare reimbursement rates used to estimate costs . Nonparametric bootstrap sampling of costs/QALY ratios established the 95 % CI around the estimates . Results .Aquatic exercisers reported equal ( QWB ) or better ( CHDR , HAQ , PQOL ) health-related quality of life compared with controls . Outcomes improved with regular class attendance . Costs/QALY gained discounted at 3 % were $ 205,186 using the QWB and $ 32,643 using the CHRD . Conclusion .Aquatic exercise exceeded $ 50,000 per QALY gained using the community-weighted outcome but fell below this arbitrary budget constraint when using the participant-weighted measure . Confidence intervals around these ratios suggested wide variability of cost effectiveness of aquatic exercise To study the effect of thermal mineral water of Nagybaracska ( Hungary ) on patients with primary knee osteoarthritis in a r and omized , double-blind clinical trial , 64 patients with nonsurgical knee joint osteoarthritis were r and omly selected either into the thermal mineral water or into the tap water group in a non-spa resort village . The patients of both groups received 30-min sessions of bathing , 5 days a week for four consecutive weeks . The patients were evaluated by a blind observer immediately before and at the end of the trial using Western Ontario and McMaster Osteoarthritis ( WOMAC ) indices and follow-up assessment 3 months later . Twenty-seven patients of the 32 patients who received thermal mineral water and 25 of the 32 of those treated with tap water completed the trial . The WOMAC activity , pain , and total scores improved significantly in the thermal mineral-water-treated group . The improvement remained also at the end of the 3-month follow-up . The WOMAC activity , pain , and total scores improved significantly also in the tap water group at the end of the treatment course , but no improvement was detected at the end of the 3-month follow-up period . The treatment with the thermal mineral water of Nagybaracska significantly improved activity , pain , and total WOMAC scores of patients with nonsurgical OA of the knee . Even after 3 months , significant improvement was observed compared to the scores before the treatment or to tap water treatment Background and Purpose Aquatic physical therapy is frequently used in the management of patients with hip and knee osteoarthritis ( OA ) , yet there is little research establishing its efficacy for this population . The purpose of this study was to evaluate the effects of aquatic physical therapy on hip or knee OA . Subjects A total of 71 volunteers with symptomatic hip OA or knee OA participated in this study . Methods The study was design ed as a r and omized controlled trial in which participants r and omly received 6 weeks of aquatic physical therapy or no aquatic physical therapy . Outcome measures included pain , physical function , physical activity levels , quality of life , and muscle strength . Results The intervention result ed in less pain and joint stiffness and greater physical function , quality of life , and hip muscle strength . Totals of 72 % and 75 % of participants reported improvements in pain and function , respectively , compared with only 17 % ( each ) of control participants . Benefits were maintained 6 weeks after the completion of physical therapy , with 84 % of participants continuing independently . Discussion and Conclusion Compared with no intervention , a 6-week program of aquatic physical therapy result ed in significantly less pain and improved physical function , strength , and quality of life . It is unclear whether the benefits were attributable to intervention effects or a placebo response OBJECTIVE To examine the reliability of postural sway assessment in women with lower extremity arthritis and to ascertain the effects of an aquatic exercise intervention program on these measures . DESIGN The reliability of postural sway measures was analyzed by within-subjects ( Subject times Trial ) analysis of variance ( ANOVA ) . The effects of aquatic exercise were analyzed by repeated measures ANOVA using a planned comparison approach with an independent 2 x 2 ( Group times Test ) design . SETTING Testing in a motor control research laboratory ; aquatic exercise in a warm water pool at an area YMCA . PARTICIPANTS Volunteer sample , 24 women with lower extremity arthritis ( rheumatoid [ RA ] n = 11 , osteo [ OA ] n = 13 ) r and omly assigned into an aquatic exercise group ( n = 14 ) or control group ( n = 10 ) . INTERVENTION Postural sway measures under a two-legged stance test on two separate test days : day 1 , pretest ; day 2 , posttest , administered after a 6-week aquatic exercise program . RESULTS Reliability correlation coefficients for postural sway measures ranged from .64 to .94 for both subject groups . Aquatic exercise subjects significantly reduced lateral sway and total sway area scores ( by 18 % to 30 % ) under both visual conditions after the 6-week intervention . Postural sway scores were significantly higher under the no-vision condition than under the vision condition in each group for both test sessions . Both OA and RA groups had normal sagittal/lateral ratio scores . CONCLUSION Women with lower extremity arthritis can be reliably assessed on postural sway measures on a stable two-legged stance test . Although they had normal sagittal/lateral sway ratio scores ( ie , scores typical for nonarthritic peers ) , vision played an important role in their postural stability for this balance task . Aquatic exercise reduced postural sway in women with lower extremity arthritis , as demonstrated by a two-legged stance test , and this exercise program appears to be a viable treatment for increasing postural stability in this population CONTEXT R and omized trials with adequate sample size offer an opportunity to assess the safety of new medications in a controlled setting ; however , generalizable data on drug safety reporting are sparse . OBJECTIVE To scrutinize the completeness of safety reporting in r and omized trials . DESIGN , SETTING , AND PATIENTS Survey of safety reporting in 192 r and omized drug trials 7 diverse topics with sample sizes of at least 100 patients and at least 50 patients in a study arm ( N = 130074 patients ) . Trial reports were identified from comprehensive meta-analyses in 7 medical areas . MAIN OUTCOME MEASURES Adequate reporting of specific adverse effects and frequency and reasons for withdrawals due to toxic effects ; article space allocated to safety reporting and predictors of such reporting . RESULTS Severity of clinical adverse effects and laboratory-determined toxicity was adequately defined in only 39 % and 29 % of trial reports , respectively . Only 46 % of trials stated the frequency of specific reasons for discontinuation of study treatment due to toxicity . For these 3 parameters , there was significant heterogeneity in rates of adequate reporting across topics ( P = .003 , P<.001 , and P = .02 , respectively ) . Overall , the median space allocated to safety results was 0.3 page . A similar amount of space was devoted to contributor names and affiliations ( P = .16 ) . On average , the percentage of space devoted to safety in the results section was 9.3 % larger in trials involving dose comparisons than in those that did not ( P<.001 ) and 3.8 % smaller in trials reporting statistically significant results for efficacy outcomes ( P = .047 ) . CONCLUSIONS The quality and quantity of safety reporting vary across medical areas , study design s , and setting s but they are largely inadequate . Current st and ards for safety reporting in r and omized trials should be revised to address this inadequacy Previous research suggests that water exercise improves the activities of daily living ( ADL ) ability of the frail elderly , but the specific frequency and intensity of such programs is unclear . This study aims at comparing the effects of once- and twice-weekly water exercise on the ADL ability of frail elderly receiving nursing care for 2 years . The design is a prospect i ve r and omized longitudinal study . Participants were assigned to two different exercise groups ( Group 1 and Group 2 ) . Group 1 participated in a 60-min exercise session once a week , for 2 years , while Group 2 attended the session twice a week . Exercise sessions were divided into a 10-min warm-up on l and and 50 min of exercise in water . The 50-min water exercise program consisted of 20 min walking , 10 min ADL exercise , 10 min stretching and strength exercises , and 10 min relaxation in water . ADL ability and lower muscle strength were measured before the beginning of exercise and 6 months , 1 year , and 2 years after the program had started . Significant group differences occurred for bathing transfer and stair climbing at the 2-year measurement . These results suggested that at least twice-weekly water exercise was necessary to maintain the ADL ability and KEX of the frail elderly during the 1-year water exercise period and for one additional year afterward BACKGROUND Balneotherapy is an established treatment modality for musculoskeletal disease , but few studies have examined the efficacy of spa therapy
Output:
| No serious adverse events were reported in the included trials with relation to aquatic exercise .
AUTHORS ' CONCLUSIONS There is moderate quality evidence that aquatic exercise may have small , short-term , and clinical ly relevant effects on patient-reported pain , disability , and QoL in people with knee and hip OA . |
MS213595 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective : To assess whether the type of scale used ( scaling effects ) and the severity of outcome ( outcome severity ) influence patients ’ numerical interpretations of verbal probability expressions . Design : Cross-sectional survey of patients in a general medicine clinic . Setting : A university-based Department of Veterans Affairs Medical Center . Participants : 210 patients seen consecutively in a general medicine clinic . Measurements and results : The patients were r and omized to scale and health outcome ( complications of surgery ) . Two scales ( a long form and a short form ) were used to expressly allow patients to choose probabilities less than 1 % . The long form had a lower bound of “ < 1 out of 1,000,000 ” ; the short form had a lower bound of “ < 1 out of 1,000 . ” Two complications were used : “ death from anesthesia ” and “ severe pneumonia . ” In the context of being told that their surgeon believed that the chance the complication would occur was “ rare , ” patients were asked to give the numerical estimate of that chance . The values elicited on both scales were significantly different for the two outcomes , with the “ rare ” risk of death from anesthesia being characterized as less likely than the “ rare ” risk of severe pneumonia ( F=5.24 , p=0.023 ) . Linear regression and three-factor analysis of variance showed significant differences in the probabilities elicited for scale , outcome , and age , with older patients generally responding with higher probabilities than did younger patients . Conclusions : These findings suggest that the severity of the associated outcome and the scale used to elicit patients ’ numerical estimates of verbal probability expressions influence patients ’ quantitative interpretations of the verbal probability statement ; and older patients respond with higher probabilities of negative outcomes than do younger patients . Future studies must continue to explore whether verbal probability expressions are adequate for communicating medical risk to patients or whether patients should be provided with numerical estimates of frequency OBJECTIVES The study evaluated the interpretation of , and preferences for , numerical information on side-effect incidence when presented in three different formats . METHODS It used a controlled design , with participants allocated at r and om to receive one of the three formats . Participants were recruited via a pop-up window on the CancerHelp UK website . The sample comprised 129 website users , of whom 96 % were women and 86 % had cancer , who received frequency information on four side effects of tamoxifen , using one of three risk expressions ( percentages , e.g. ' affects 25 % of people ' ; frequencies , e.g. ' affects 1 in 4 people ' ; combined , e.g. ' affects 1 in 4 people ( 25 % ) ' ) . They then interpreted information on tamoxifen and its effect on health , and estimates of side-effect frequency , and then stated a preference from the three risk expression formats . KEY FINDINGS The results showed that the three formats did not influence participants ' ratings of the information or their side-effect estimates . However , more than half ( 53 % ) the participants preferred the combined ( frequency and percentage ) format . In conclusion , a combined risk expression format performed no worse than percentages or frequencies alone and was preferred by a majority . CONCLUSIONS The three risk expression formats did not differ in their effect on participants ' interpretations . However , the preferred format was the combined ( frequency and percentage ) risk expression OBJECTIVE The objective of this r and omized controlled trial was to evaluate the efficacy of presenting information on the risks of side effects from a medicine , presented in different formats . METHODS A r and omized , parallel-group , single-center controlled trial was conducted among adult users of a training pharmacy . The information was categorized into the following groups : verbal descriptors+percentage range , percentage range and absolute percentage . The main outcomes were gist underst and ing and verbatim underst and ing , classified either as adequate or inadequate . The analyses were performed using ANOVA and Pearson 's chi-square test . RESULTS A total of 393 participants were recruited from June to October 2015 . Adequate levels of gist underst and ing and verbatim underst and ing were respectively 65.6 % and 53.9 % for the verbal descriptors+percentage range ( n=128 ) , 63.4 % and 44.3 % for percentage range ( n=131 ) , and 62.3 % and 48.5 % for absolute percentage ( n=131 ) , with no statistically significant difference between the groups ( p=0.852 and p=0.299 , respectively ) . CONCLUSION The underst and ing of the information was similar in all three formats , but the percentages of adequate underst and ing were low . PRACTICAL IMPLICATION S The percentage of inadequate underst and ing demonstrated in this study indicates that alternative formats for reporting adverse reactions need to be evaluated Objective : To determine whether the use of verbal descriptors suggested by the European Union ( EU ) such as “ common ” ( 1–10 % frequency ) and “ rare ” ( 0.01–0.1 % ) effectively conveys the level of risk of side effects to people taking a medicine . Design : R and omised controlled study with unconcealed allocation . Participants : 120 adults taking simvastatin or atorvastatin after cardiac surgery or myocardial infa rct ion . Setting : Cardiac rehabilitation clinics at two hospitals in Leeds , UK . Intervention : A written statement about one of the side effects of the medicine ( either constipation or pancreatitis ) . Within each side effect condition half the patients were given the information in verbal form and half in numerical form ( for constipation , “ common ” or 2.5 % ; for pancreatitis , “ rare ” or 0.04 % ) . Main outcome measure : The estimated likelihood of the side effect occurring . Other outcome measures related to the perceived severity of the side effect , its risk to health , and its effect on decisions about whether to take the medicine . Results : The mean likelihood estimate given for the constipation side effect was 34.2 % in the verbal group and 8.1 % in the numerical group ; for pancreatitis it was 18 % in the verbal group and 2.1 % in the numerical group . The verbal descriptors were associated with more negative perceptions of the medicine than their equivalent numerical descriptors . Conclusions : Patients want and need underst and able information about medicines and their risks and benefits . This is essential if they are to become partners in medicine taking . The use of verbal descriptors to improve the level of information about side effect risk leads to overestimation of the level of harm and may lead patients to make inappropriate decisions about whether or not they take the medicine OBJECTIVE To determine whether the public has different expectations of nonprescription medications based on location of sale . DESIGN Cross-sectional , descriptive . SETTING Saskatoon , Saskatchewan , Canada , during the summer of 2003 . PARTICIPANTS 2,102 r and omly selected citizens . INTERVENTION Mail survey . MAIN OUTCOME MEASURES Differences in expectations for potency , safety , adverse effects , effectiveness , and package information of products sold in pharmacies versus convenience stores . RESULTS The response rate was 57.2 % . Most participants ( 81.2 % ) were aware that nonprescription medications could be purchased in convenience stores , but far fewer ( 42.3 % ) had done so . As one potential re source during purchases , pharmacists were held in reasonably high regard . Expectations with the greatest difference were of a merch and ising nature . Respondents expected pharmacies to have a better quality and selection of products and lower prices . For drug-related attributes , differences were minimal but statistically significant . CONCLUSION Location of sale does not appear to have any practical influence on consumer expectations of the drug-related attributes of nonprescription medications . Buyers of such products expect similar properties to be present regardless of location Abstract Background : All licensed medicines in the European Union must be provided with a Patient Information Leaflet that includes a list of all known side effects . Among patients who read the leaflet , the side effects section is the most often read . A UK government regulatory publication recommends providing medicine side effect risk information in a combined format , using verbal descriptors accompanied by numerical information . Objectives : This study , with users of an existing popular patient information website , investigates the effectiveness of presenting medicine side effect risk information in different forms . Design : Participants were r and omly allocated to one of the three formats for representing risk information ( verbal descriptors , e.g. ‘ common ’ ; absolute frequencies , e.g. ‘ less than 1 in 10 people ’ ; and a combination of verbal descriptors and frequency b and s , e.g. ‘ common ( affects less than 1 in 10 people ) ’ . Methods : Participants ( n= 187 ) were recruited from users of the Cancer Research UK patient information website . They were asked to imagine that they had to take a cancer treatment ( tamoxifen ) , estimate the risks of four side effects occurring , and complete Likert scales relating to their satisfaction with the information supplied and perceived likelihood of various outcomes . Results : Those in the absolute frequency format demonstrated greater accuracy in estimating the likelihood of having two of four side effects than the other two formats . They were also more accurate at estimating the likelihood of themselves or the average person having any side effect from taking tamoxifen . Participants in the absolute frequency format rated the risk to health from tamoxifen as lower than those in the other two formats , were more satisfied with the information they received than those in the verbal format , and felt there would be less impact of the information on tamoxifen use than those in the combined format . Conclusions : These findings fail to confirm that the recommended use of combined descriptors for medicine side effects is unequivocally superior to absolute frequency alone . They also add weight to the growing body of research highlighting the deficiencies in using verbal descriptors for conveying side effect risk , and the strength of using absolute frequency descriptors BACKGROUND : Several studies suggest that many parents and research participants have poor underst and ing of the elements of consent , particularly the risks and benefits . However , some data suggest that the format and framing of research risks and benefits may be an important determinant of subject underst and ing . We examined the effect of tabular and graphical presentation of risks and benefits on parents ' underst and ing of a research study . METHODS : Parents of children scheduled to undergo an elective surgical procedure ( n = 408 ) were r and omized to receive information about the risks and benefits of a sham study of postoperative pain control using text , tables , or pictographs and then completed a question naire to examine their gist ( essential ) and verbatim ( actual ) underst and ing of the information . Parent demographics were recorded and their literacy and numeracy skills measured . RESULTS : Parents r and omized to receive information using tables or pictographs had significantly ( P < 0.025 ) greater gist and verbatim underst and ing than did parents who received the information using st and ard text . Tables and pictographs were also superior to text in promoting underst and ing among parents with low numeracy and literacy skills . CONCLUSIONS : Many parents and patients have difficulty in assimilating and interpreting risk/benefit information for both research and treatment . This is due , in part , to the manner in which risks and benefits are communicated and to the literacy and numeracy abilities of the individual . The results of this study suggest a simple and practical method for enhancing underst and ing of risk/benefit statistics for parents with varying numeracy and literacy skills OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity CONTEXT Patients with cancer undergoing similar treatments experience variable severity and frequency of side effects not adequately explained by pharmacological mechanisms , suggesting psychological influence . OBJECTIVES First , this study aim ed to further examine the relationship between patients ' expectations of multiple chemotherapy-related toxicities and experiences . Second , this study aim ed to explore the impact of anxiety and cancer coping styles to aid in informing interventions to lessen such expectations . METHODS A total of 59 eligible , consenting patients with cancer rated their expectations of 20 chemotherapy toxicities on 100-point linear analogue self- assessment indicators before treatment and completed the Spielberger State Anxiety Inventory and the Mental Adjustment to
Output:
| DISCUSSION AND CONCLUSIONS Decreasing unrealistic side-effect expectations may lead to decreased experience of side-effects and increased adherence to medical interventions . |
MS213596 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Videogame play ( VGP ) has been associated with numerous preferred and non-preferred effects . However , the effects of VGP on the development of microstructural properties in children , particularly those associated with negative psychological consequences of VGP , have not been identified to date . The purpose of this study was to investigate this issue through cross-sectional and longitudinal prospect i ve analyses . In the present study of humans , we used the diffusion tensor imaging mean diffusivity ( MD ) measurement to measure microstructural properties and examined cross-sectional correlations with the amount of VGP in 114 boys and 126 girls . We also assessed correlations between the amount of VGP and longitudinal changes in MD that developed after 3.0±0.3 ( s.d . ) years in 95 boys and 94 girls . After correcting for confounding factors , we found that the amount of VGP was associated with increased MD in the left middle , inferior and orbital frontal cortex ; left pallidum ; left putamen ; left hippocampus ; left cau date ; right putamen ; right insula ; and thalamus in both cross-sectional and longitudinal analyses . Regardless of intelligence quotient type , higher MD in the areas of the left thalamus , left hippocampus , left putamen , left insula and left Heschl gyrus was associated with lower intelligence . We also confirmed an association between the amount of VGP and decreased verbal intelligence in both cross-sectional and longitudinal analyses . In conclusion , increased VGP is directly or indirectly associated with delayed development of the microstructure in extensive brain regions and verbal intelligence The n-back task was hypothesized to be a dual task , permitting the imposition of parametrically increasing attentional and working memory dem and s , while keeping constant the dem and s of an embedded matching subtask . Visual targets were presented for 200 ms every 2.2 s at pseudor and omly varying positions on a computer screen . Participants were required to remember the most recent 0 , 1 , 2 , or 3 positions and responded with a choice button push to whether the current target position matched the position presented n items previously . P300 peak latency was constant across n-back tasks , reflecting constant perceptual and cognitive dem and s of the matching subtask . P300 peak amplitude decreased with increasing memory load , reflecting reallocation of attention and processing capacity away from the matching subtask to working memory activity . These data support a dual-task nature of the n-back , which should be considered when employing this paradigm This study sought to determine whether playing a “ serious ” interactive digital game ( IDG ) – the Re-Mission videogame for cancer patients – activates mesolimbic neural circuits associated with incentive motivation , and if so , whether such effects stem from the participatory aspects of interactive gameplay , or from the complex sensory/perceptual engagement generated by its dynamic event-stream . Healthy undergraduates were r and omized to groups in which they were scanned with functional magnetic resonance imaging ( FMRI ) as they either actively played Re-Mission or as they passively observed a gameplay audio-visual stream generated by a yoked active group subject . Onset of interactive game play robustly activated mesolimbic projection regions including the cau date nucleus and nucleus accumbens , as well as a subregion of the parahippocampal gyrus . During interactive gameplay , subjects showed extended activation of the thalamus , anterior insula , putamen , and motor-related regions , accompanied by decreased activation in parietal and medial prefrontal cortex . Offset of interactive gameplay activated the anterior insula and anterior cingulate . Between-group comparisons of within-subject contrasts confirmed that mesolimbic activation was significantly more pronounced in the active playgroup than in the passive exposure control group . Individual difference analyses also found the magnitude of parahippocampal activation following gameplay onset to correlate with positive attitudes toward chemotherapy assessed both at the end of the scanning session and at an unannounced one-month follow-up . These findings suggest that IDG-induced activation of reward-related mesolimbic neural circuits stems primarily from participatory engagement in gameplay ( interactivity ) , rather than from the effects of vivid and dynamic sensory stimulation As video-game playing has become a ubiquitous activity in today 's society , it is worth considering its potential consequences on perceptual and motor skills . It is well known that exposing an organism to an altered visual environment often results in modification of the visual system of the organism . The field of perceptual learning provides many examples of training-induced increases in performance . But perceptual learning , when it occurs , tends to be specific to the trained task ; that is , generalization to new tasks is rarely found . Here we show , by contrast , that action-video-game playing is capable of altering a range of visual skills . Four experiments establish changes in different aspects of visual attention in habitual video-game players as compared with non-video-game players . In a fifth experiment , non-players trained on an action video game show marked improvement from their pre-training abilities , thereby establishing the role of playing in this effect The authors investigated the effect of action gaming on the spatial distribution of attention . The authors used the flanker compatibility effect to separately assess center and peripheral attentional re sources in gamers versus nongamers . Gamers exhibited an enhancement in attentional re sources compared with nongamers , not only in the periphery but also in central vision . The authors then used a target localization task to unambiguously establish that gaming enhances the spatial distribution of visual attention over a wide field of view . Gamers were more accurate than nongamers at all eccentricities tested , and the advantage held even when a concurrent center task was added , ruling out a trade-off between central and peripheral attention . By establishing the causal role of gaming through training studies , the authors demonstrate that action gaming enhances visuospatial attention throughout the visual field BACKGROUND AND OBJECTIVE Neuroimaging studies have demonstrated dysfunction in the brain reward circuit in individuals with online gaming addiction ( OGA ) . We hypothesized that virtual reality therapy ( VRT ) for OGA would improve the functional connectivity ( FC ) of the cortico-striatal-limbic circuit by stimulating the limbic system . METHODS Twenty-four adults with OGA were r and omly assigned to a cognitive behavior therapy ( CBT ) group or VRT group . Before and after the four-week treatment period , the severity of OGA was evaluated with Young 's Internet Addiction Scale ( YIAS ) . Using functional magnetic resonance imaging , the amplitude of low-frequency fluctuation ( ALFF ) and FC from the posterior cingulate cortex ( PCC ) seed to other brain areas were evaluated . Twelve casual game users were also recruited and underwent only baseline assessment . RESULTS After treatment , both CBT and VRT groups showed reductions in YIAS scores . At baseline , the OGA group showed a smaller ALFF within the right middle frontal gyrus and reduced FC in the cortico-striatal-limbic circuit . In the VRT group , connectivity from the PCC seed to the left middle frontal and bilateral temporal lobe increased after VRT . CONCLUSION VRT seemed to reduce the severity of OGA , showing effects similar to CBT , and enhanced the balance of the cortico-striatal-limbic circuit Cognitive control is defined by a set of neural processes that allow us to interact with our complex environment in a goal -directed manner . Humans regularly challenge these control processes when attempting to simultaneously accomplish multiple goals ( multitasking ) , generating interference as the result of fundamental information processing limitations . It is clear that multitasking behaviour has become ubiquitous in today ’s technologically dense world , and substantial evidence has accrued regarding multitasking difficulties and cognitive control deficits in our ageing population . Here we show that multitasking performance , as assessed with a custom- design ed three-dimensional video game ( NeuroRacer ) , exhibits a linear age-related decline from 20 to 79 years of age . By playing an adaptive version of NeuroRacer in multitasking training mode , older adults ( 60 to 85 years old ) reduced multitasking costs compared to both an active control group and a no-contact control group , attaining levels beyond those achieved by untrained 20-year-old participants , with gains persisting for 6 months . Furthermore , age-related deficits in neural signatures of cognitive control , as measured with electroencephalography , were remediated by multitasking training ( enhanced midline frontal theta power and frontal – posterior theta coherence ) . Critically , this training result ed in performance benefits that extended to untrained cognitive control abilities ( enhanced sustained attention and working memory ) , with an increase in midline frontal theta power predicting the training-induced boost in sustained attention and preservation of multitasking improvement 6 months later . These findings highlight the robust plasticity of the prefrontal cognitive control system in the ageing brain , and provide the first evidence , to our knowledge , of how a custom- design ed video game can be used to assess cognitive abilities across the lifespan , evaluate underlying neural mechanisms , and serve as a powerful tool for cognitive enhancement The ultimate goal of cognitive enhancement as an intervention for age-related cognitive decline is transfer to everyday cognitive functioning . Development of training methods that transfer broadly to untrained cognitive tasks ( far transfer ) requires underst and ing of the neural bases of training and far transfer effects . We used cognitive training to test the hypothesis that far transfer is associated with altered attentional control dem and s mediated by the dorsal attention network and trained sensory cortex . In an exploratory study , we r and omly assigned 42 healthy older adults to six weeks of training on Brain Fitness ( BF-auditory perception ) , Space Fortress ( SF-visuomotor/working memory ) , or Rise of Nations ( RON-strategic reasoning ) . Before and after training , cognitive performance , diffusion-derived white matter integrity , and functional connectivity of the superior parietal cortex ( SPC ) were assessed . We found the strongest effects from BF training , which transferred to everyday problem solving and reasoning and selectively changed integrity of occipito-temporal white matter associated with improvement on untrained everyday problem solving . These results show that cognitive gain from auditory perception training depends on heightened white matter integrity in the ventral attention network . In BF and SF ( which also transferred positively ) , a decrease in functional connectivity between SPC and inferior temporal lobe ( ITL ) was observed compared to RON-which did not transfer to untrained cognitive function . These findings highlight the importance for cognitive training of top-down control of sensory processing by the dorsal attention network . Altered brain connectivity - observed in the two training tasks that showed far transfer effects - may be a marker for training success The ability to remember and navigate spatial environments is critical for everyday life . A primary mechanism by which the brain represents space is through hippocampal place cells , which indicate when an animal is at a particular location . An important issue is underst and ing how the hippocampal place-cell network represents specific properties of the environment , such as signifying that a particular position is near a doorway or that another position is near the end of a corridor . The entorhinal cortex ( EC ) , as the main input to the hippocampus , may play a key role in coding these properties because it contains neurons that activate at multiple related positions per environment . We examined the diversity of spatial coding across the human medial temporal lobe by recording neuronal activity during virtual navigation of an environment containing four similar paths . Neurosurgical patients performed this task as we recorded from implanted microelectrodes , allowing us to compare the human neuronal representation of space with that of animals . EC neurons activated in a repeating manner across the environment , with individual cells spiking at the same relative location across multiple paths . This finding indicates that EC cells represent non-specific information about location relative to an environment 's geometry , unlike hippocampal place cells , which activate at particular r and om locations . Given that spatial navigation is considered to be a model of how the brain supports non-spatial episodic memory , these findings suggest that EC neuronal activity is used by the hippocampus to represent the properties of different memory episodes Video games contain elaborate reinforcement and reward schedules that have the potential to maximize motivation . Neuroimaging studies suggest that video games might have an influence on the reward system . However , it is not clear whether reward-related properties represent a precondition , which biases an individual toward playing video games , or if these changes are the result of playing video games . Therefore , we conducted a longitudinal study to explore reward-related functional predictors in relation to video gaming experience as well as functional changes in the brain in response to video game training . Fifty healthy participants were r and omly assigned to a video game training ( TG ) or control group ( CG ) . Before and after training/control period , functional magnetic resonance imaging ( fMRI ) was conducted using a non-video game related reward task . At pretest , both groups showed strongest activation in ventral striatum ( VS ) during reward anticipation . At posttest , the TG showed very similar VS activity compared to pretest . In the CG , the VS activity was significantly attenuated . This longitudinal study revealed that video game training may preserve reward responsiveness in the VS in a retest situation over time . We suggest that video games are able to keep striatal responses to reward flexible , a mechanism which might be of critical value for applications such as therapeutic cognitive training Internet gaming disorder ( IGD ) is a subtype of internet addiction disorder ( IAD ) , but its pathogenesis remains unclear . This study investigated brain function in IGD individuals using task-state functional magnetic resonance imaging ( fMRI ) . It is a prospect i ve study in 19 IGD individuals and 19 matched healthy controls . They all received internet videogame stimuli while a 3.0 T fMRI was used to assess echo planar imaging . Brain activity was analyzed using the Brain Voyager software package . Functional data were spatially smoothed using Gaussian kernel . The threshold level was positioned at 10 pixels , and the activation range threshold was set to 10 voxels . Activated brain regions were compared between the two groups , as well as the amount of activated voxels . The internet videogame stimuli activated brain regions in both groups . Compared with controls , the IGD group showed increased activation in the right superior parietal lobule , right insular lobe , right precuneus , right cingulated gyrus , right superior temporal gyrus , and left brainstem . There was a significant difference in the number of activated voxels between the two groups .
Output:
| Conclusions : Despite the innate heterogeneity of the field of study , it has been possible to establish a series of links between the neural and cognitive aspects , particularly regarding attention , cognitive control , visuospatial skills , cognitive workload , and reward processing .
However , many aspects could be improved . |
MS213597 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Population aging portends a crisis of re sources and values . Desired solutions could include intergenerational strategies to harness the untapped potential of older adultsto address societal needs and to generate health improvements for older adults . Despite the desire of many older adults to remain socially engaged and productive , the creation of productive roles has lagged . This report describes the conceptual framework and major design features of a new model of health promotion for older adults called Experience Corps ® . Experience Corps operates at , and leads to benefits , across multiple levels , including individuals , schools , and the larger community . At the individual level , we propose a model based on Erikson ’s concept of generativity to explain bow and why experience Corps works . At the level of schools , we propose a parallel model based on social capital . Experience Corps is a volunteer service program design ed to improve the lives of urban childre and to yield health improvement for older persons . It illustrates how population aging creates new opportunities to address difficult social problems . This article explores how the linkage of concepts at multiple levels motivates a potentially cost-effective , feasible , and high-impact program This report evaluates whether a program for older volunteers , design ed for both benerativity and health promotion , leads to short-term improvements inmultiple behavioral risk factors and positive effects on intermediary risk factors for disability and other morbidities . The Experience Corps ® places older volunteers in public elementary schools in roles design ed to meet schools ’ needs and increase the social , physical , and cognitive activity of the volunteers . This article reports on a pilot r and omized trial in Baltimore , Maryl and . The 128 volunteers were 60–86 years old ; 95 % were African American . At follow-up of 4–8 months , physical activity , strength , people one could turn to for help , and cognitive activity increased significantly , and walking speed decreased significantly less , in participants compared to controls . In this pilot trial , physical , cognitive , and social activity increased , suggesting the potential for the Experience Corps to improve health for an aging population and simultaneously improve educational outcomes for children OBJECTIVES We aim to underst and how human , social , and cultural capitals are associated with the volunteer process , that is , engagement ( starting ) , intensity ( number of hours ) , and cessation ( stopping ) , among older adults . METHOD Data from the 2000 through 2008 Health and Retirement Study and the 2001 through 2009 Consumption and Activity Mail Survey provide a sample of 4,526 respondents . R and om-effects pooled time series analyses incorporate not only the presence of various types of capital but also the quality of that capital . RESULTS Human and cultural capitals were positively associated with increased volunteer involvement . Effects of social capital ( relationships in the family , employment status , and the community ) depended on the quality of the relationships , not necessarily on their presence alone . DISCUSSION Results suggest that bolstering older adults ' capitals , particularly among lower socioeconomic status groups , can increase volunteer engagement and intensity and reduce cessation . Additionally , a variety of organizational policies including respite programs for caregivers and employer policies allowing employees to reduce their work hours might indirectly affect participation rates and commitment . Potential pools of volunteers exist in families , workplaces , and religious organizations , but more research is necessary to identify how to recruit and retain individuals in social networks where volunteer participatory rates are low The effect of a health education course guided by peers aged 55 and over was evaluated . The aim of the course was to empower older adults to participate in society and to promote their wellbeing . Evaluation included determining the effect on attitude toward aging , self-efficacy , perception of the societal opinion regarding the place of the elderly in society ( social influence ) , social participation , perceived social support , and wellbeing of the participants aged 55 to 79 years . A quasi-experimental approach was used . The effect on the experimental group of course participants was studied compared to a control group of older adults on the waiting list . The respondents filled out postal question naires at three time points ( before starting the course ( t0 ) , immediately after termination ( t1 ) and three months later ( t2 ) ) . Using a multivariate analysis procedure , a significant interaction effect between time of measurement and group membership was found with respect to the outcome of social influence . At t1 an effect was absent , but at t2 , the current idea that elderly occupy a marginal position in society , found less favour with the experimental group than the control group . Moreover perceived social support and subjective health improved significantly at t1 and t2 among the course members , when compared to the control group . No effect was found on attitude , self-efficacy , social participation and wellbeing in the short time span of a three months follow-up PURPOSE There is little empirical translation of multimodal cognitive activity programs in " real-world " community-based setting s. This study sought to demonstrate in a short-term pilot r and omized trial that such an activity program improves components of cognition critical to independent function among sedentary older adults at greatest risk . DESIGN AND METHODS We r and omized 149 older adults to Experience Corps ( EC ) or a wait-list control arm . Participants r and omized to EC trained in teams to help elementary school children with reading achievement , library support , and classroom behavior for 15 hr/week during an academic year . We compared baseline and follow-up assessment s of memory , executive function ( EF ) , and psychomotor speed at 4 to 8 months by intervention arm , adjusting for exposure duration . We observed a range of EF abilities at baseline and stratified analyses according to the presence of baseline impairment using established norms . RESULTS Overall , EC participants tended to show improvements in EF and memory relative to matched controls ( ps < .10 ) . EC participants with impaired baseline EF showed the greatest improvements , between 44 % and 51 % in EF and memory at follow-up , compared to declines among impaired-EF controls ( ps < .05 ) . IMPLICATION S Short-term participation in this community-based program design ed to increase cognitive and physical activity in a social , real-world setting may train memory and , particularly , executive functions important to functional independence . This community-based program represents one potentially effective model to bring high doses of sustainable cognitive exercise to the greatest proportion of older adults , particularly those sedentary individuals at elevated risk for health disparities
Output:
| Interventions providing explicit roles and using supportive group structures were somewhat effective in improving one or more of the following : life satisfaction , social support and activity , physical health and activity , functional health , and cognition .
CONCLUSIONS Social role interventions may improve health and well-being for people in retirement transition . |
MS213598 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIMS Flavanol-rich chocolate ( FRC ) is beneficial for vascular and platelet function by increasing nitric oxide bioavailability and decreasing oxidative stress . Congestive heart failure ( CHF ) is characterized by impaired endothelial and increased platelet reactivity . As statins are ineffective in CHF , alternative therapies are a clinical need . We therefore investigated whether FRC might improve cardiovascular function in patients with CHF . METHODS AND RESULTS Twenty patients with CHF were enrolled in a double-blind , r and omized placebo-controlled trial , comparing the effect of commercially available FRC with cocoa-liquor-free control chocolate ( CC ) on endothelial and platelet function in the short term ( 2 h after ingestion of a chocolate bar ) and long term ( 4 weeks , two chocolate bars/day ) . Endothelial function was assessed non-invasively by flow-mediated vasodilatation of the brachial artery . Flow-mediated vasodilatation significantly improved from 4.98 ± 1.95 to 5.98 ± 2.32 % ( P = 0.045 and 0.02 for between-group changes ) 2h after intake of FRC to 6.86 ± 1.76 % after 4 weeks of daily intake ( P = 0.03 and 0.004 for between groups ) . No effect on endothelial-independent vasodilatation was observed . Platelet adhesion significantly decreased from 3.9 ± 1.3 to 3.0 ± 1.3 % ( P = 0.03 and 0.05 for between groups ) 2 h after FRC , an effect that was not sustained at 2 and 4 weeks . Cocoa-liquor-free CC had no effect , either on endothelial function or on platelet function . Blood pressure and heart rate did not change in either group . CONCLUSION Flavanol-rich chocolate acutely improves vascular function in patients with CHF . A sustained effect was seen after daily consumption over a 4-week period , even after 12 h abstinence . These beneficial effects were paralleled by an inhibition of platelet function in the presence of FRC only Background Dark chocolate ( DC ) is abundant in flavanols which have been reported to increase the bioavailability and bioactivity of nitric oxide ( NO ) . Increasing NO bioavailability has often demonstrated reduced oxygen cost and performance enhancement during submaximal exercise . Methods Nine moderately-trained male participants volunteered to undertake baseline ( BL ) measurements that comprised a cycle V.O2max$$ \overset{.}{V}{O}_{2 max } $ $ test followed by cycling at 80 % of their established gas exchange threshold ( GET ) for 20-min and then immediately followed by a two-minute time-trial ( TT ) . Using a r and omised crossover design participants performed two further trials , two weeks apart , with either 40 g of DC or white chocolate ( WC ) being consumed daily . Oxygen consumption , RER , heart rate and blood lactate ( BLa ) were measured during each trial . Results DC consumption increased GET and TT performance compared to both BL and WC ( P < 0.05 ) . DC consumption increased V.O2max$$ \overset{.}{V}{O}_{2 max } $ $ by 6 % compared to BL ( P < 0.05 ) , but did not reach statistical significance compared to WC . There were no differences in the moderate-intensity cycling for V.O2$$ \overset{.}{V}{O}_2 $ $ , RER , BLa and heart rate between conditions , although , V.O2$$ \overset{.}{V}{O}_2 $ $ and RER exhibited consistently lower trends following DC consumption compared to BL and WC , these did not reach statistical significance . Conclusion Chronic supplementation with DC result ed in a higher GET and enhanced TT performance . Consequently , ingestion of DC reduced the oxygen cost of moderate intensity exercise and may be an effective ergogenic aid for short- duration moderate intensity exercise The consumption of a diet rich in certain flavonoids , including the flavanol sub-class , has been associated with a reduced risk for vascular disease . We evaluated the effects of the regular consumption ( 14 d ) of a flavanol-containing milk chocolate ( FCMC ) or cocoa butter chocolate ( CBC ) on variables related to vascular disease risk , oxidative stress and physical activity . Twenty-eight free-living , young ( 18–20 years old ) male soccer players consumed daily 105 g of FCMC ( 168 mg of flavanols ) or CBC ( < 5 mg of flavanols ) , as part of their normal diet . The consumption of FCMC was significantly associated with a decrease in diastolic blood pressure ( -5 mm Hg ) , mean blood pressure ( -5 mm Hg ) , plasma cholesterol ( -11 % ) , LDL-cholesterol ( -15 % ) , malondialdehyde ( -12 % ) , urate ( -11 % ) and lactate dehydrogenase ( LDH ) activity ( -11 % ) , and an increase in vitamin E/cholesterol ( + 12 % ) . No relevant changes in these variables were associated with CBC consumption . No changes in the plasma levels of (-)-epicatechin were observed following analysis of fasting blood sample s. In conclusion , FCMC consumption was associated with changes in several variables often associated with cardiovascular health and oxidant stress . The presence of significant quantities of flavanols in FCMC is likely to have been one of the contributing factors to these results Impaired endothelial vasodilatation may contribute to the exaggerated blood pressure ( BP ) responses to exercise in individuals who are overweight/obese . The present study investigated whether consumption of cocoa flavanols , which improve endothelium-dependent flow-mediated dilatation ( FMD ) , can modify BP responsiveness to exercise . Twenty-one volunteers ( eight females and thirteen males , 54.9 ( se 2.2 ) years , BMI 31.6 ( se 0.8 ) kg/m2 , systolic BP 134 ( se 2 ) mmHg , diastolic BP ( DBP ) 87 ( se 2 ) mmHg ) were r and omised to consume single servings of either a high-flavanol ( HF , 701 mg ) or a low-flavanol ( LF , 22 mg ) cocoa beverage in a double-blind , cross-over design with 3 - 7-d washout between treatments . Two hours after cocoa consumption , FMD was measured , followed by continuous beat-to-beat assessment ( Finapres ) of BP before and during 10 min of cycling at 75 % of age-predicted maximum heart rate . Averaged data from two assessment s on each type of beverage were compared by analysis of covariance using pre-exercise BP as the covariate . Pre-exercise BP was similar after taking LF and HF ( 153 ( se 3)/88 ( se 3 ) v. 153 ( se 4)/87 ( se 2 ) mmHg , respectively , P>0.05 ) . However , the BP response to exercise ( area under BP curve ) was attenuated by HF compared with LF . BP increases were 68 % lower for DBP ( P = 0.03 ) and 14 % lower for mean BP ( P = 0.05 ) . FMD measurements were higher after taking HF than after taking LF ( 6.1 ( se 0.6 ) % v. 3.4 ( se 0.5 ) % , P < 0.001 ) . By facilitating vasodilation and attenuating exercise-induced increases in BP , cocoa flavanols may decrease cardiovascular risk and enhance the cardiovascular benefits of moderate intensity exercise in at-risk individuals Dietary flavanols have been associated with reduced oxidative stress , however their efficacy in promoting recovery after exercise induced muscle damage is unclear . This study examined the effectiveness of acute consumption of cocoa-flavanols on indices of muscle recovery including : subsequent exercise performance , creatine kinase , muscle tenderness , force , and self-perceived muscle soreness . Eight endurance-trained athletes ( VO2max 64.4 ± 7.6 mL/kg/min ) completed a downhill running protocol to induce muscle soreness , and 48-h later completed a 5-K ( kilometer ) time trial . Muscle recovery measurements were taken at PRE , 24 h-POST , 48 h-POST , and POST-5 K . Participants consumed 1.0 g of carbohydrate per kilogram of body weight of a r and omly assigned beverage ( CHOC : 0 mg flavanols vs. CocoaCHOC : 350 mg flavanols per serving ) immediately after the downhill run and again 2 h later . The same protocol was repeated three weeks later with the other beverage . An ANOVA revealed no significant difference ( p = 0.97 ) between trials for 5 K completion time ( CHOC 1198.3 ± 160.6 s , CocoaCHOC 1195.5 ± 148.8 s ) . No significant difference was found for creatine kinase ( CK ) levels ( p = 0.31 ) , or muscle soreness ( p = 0.21 ) between groups over time . These findings suggest that the acute addition of cocoa flavanols to low-fat chocolate milk offer no additional recovery benefits This study investigated the effects of regular consumption of dark chocolate ( DC ) , rich in cocoa polyphenols , on plasma metabolites , hormones , and markers of oxidative stress after prolonged exhaustive exercise . Twenty active men cycled at 60 % maximal oxygen uptake ( VO2max ) for 1.5 hr , with the intensity increased to 90 % VO2max for a 30-s period every 10 min , followed by a ride to exhaustion at 90 % VO2max . In the 2 wk before exercise participants consumed 40 g of DC or an isocarbohydrate-fat control cocoa liquor-free chocolate ( CON ) twice daily and once 2 hr before exercise in a r and omized , counterbalanced , crossover design . Venous blood sample s were taken immediately before exercise , postexercise ( fixed duration ) , postexhaustion , and after 1 hr of recovery . F2-isoprostanes were significantly lower ( post hoc tests : p < .001 ) at exhaustion and after 1 hr of recovery with DC . Oxidized low-density lipoproteins were significantly lower with DC ( p < .001 ) both before and after exercise and at exhaustion . DC was also associated with ~21 % greater rises in free fatty acids during exercise ( main effect : p < .05 ) . Changes in circulating glucose , insulin , glucagon , cortisol , and interleukin (IL)-6 , IL-10 , and IL-1ra were unaffected by treatment . Time to exhaustion at 90 % VO2max was not significantly different between trials ( 398 ± 204 and 374 ± 194 s for DC and CON , respectively ) . These results suggest that regular DC intake is associated with reduced oxidative-stress markers and increased mobilization of free fatty acids after exercise but has no observed effect on exercise performance OBJECTIVES This study was design ed to assess the effect of flavanol-rich food on the circulating pool of bioactive nitric oxide ( NO ) and endothelial dysfunction in smokers . BACKGROUND Studies suggest that smoking-related vascular disease is caused by impaired NO synthesis and that diets rich in flavanols can increase bioactive NO in plasma . METHODS In smokers ( n = 11 ) , the effects of flavanol-rich cocoa on circulating NO species in plasma ( RXNO ) measured by reductive gas-phase chemiluminescence and endothelial function as assessed by flow-mediated dilation ( FMD ) were characterized in a dose-finding study orally administering cocoa containing 88 to 370 mg flavanols and in a r and omized double-blind crossover study using 100 ml cocoa drink with high ( 176 to 185 mg ) or low ( < 11 mg ) flavanol content on two separate days . In addition to cocoa drink , ascorbic acid and NO-synthase inhibitor L-NMMA ( n = 4 ) were applied . RESULTS There were significant increases in RXNO ( 21 + /- 3 nmol/l to 29 + /- 5 nmol/l ) and FMD ( 4.5 + /- 0.8 % to 6.9 + /- 0.9 % , each p < 0.05 ) at 2 h after ingestion of 176 to 185 mg flavanols , a dose potentially exerting maximal effects . These changes correlated with increases in flavanol metabolites . Cocoa-associated increases in RXNO and FMD were reversed by L-NMMA . Ascorbic acid had no effect . CONCLUSIONS The circulating pool of bioactive NO and endothelium-dependent vasodilation is acutely increased in smokers following the oral ingestion of a flavanol-rich cocoa drink . The increase in circulating NO pool may contribute to beneficial vascular health effects of flavanol-rich food Acute exercise-induced improvements in cognitive function are accompanied by increased ( cerebral ) blood flow and increased brain-derived neurotrophic factor ( BDNF ) levels . Acute cocoa flavanol ( CF ) intake may improve cognitive function , cerebral blood flow ( in humans ) , and BNDF levels ( in animals ) . This study investigated ( i ) the effect of CF intake in combination with exercise on cognitive function and ( ii ) cerebral hemodynamics and
Output:
| Results Acute , sub-chronic ( 2 weeks ) and chronic ( 3 months ) CF intake reduced exercise-induced oxidative stress .
Evidence on the effect of CF on exercise-induced inflammation and platelet activation was scarce .
Acute CF intake reduced and tempered the exercise-induced increase in blood pressure in obese participants .
Acute and sub-chronic CF intake altered fat and carbohydrate metabolism during exercise .
Acute and sub-chronic CF intake did not have ergogenic effects in athletes , while chronic CF intake improved mitochondrial efficiency in untrained participants .
While combining sub-chronic CF intake and exercise training improved cardiovascular risk factors and vascular function , evidence on the synergistic effects of CF and exercise training on oxidative stress , inflammation , and fat and glucose metabolism was lacking .
Conclusion CF intake may improve vascular function , reduce exercise-induced oxidative stress , and alter fat and carbohydrate utilization during exercise , but without affecting exercise performance . |
MS213599 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Cigarette smoking is a tough addiction to break . Therefore , improved approaches to smoking cessation are necessary . The electronic-cigarette ( e-Cigarette ) , a battery-powered electronic nicotine delivery device ( ENDD ) resembling a cigarette , may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption . Efficacy and safety of these devices in long-term smoking cessation and /or smoking reduction studies have never been investigated . Methods In this prospect i ve proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers ( unwilling to quit ) experimenting the ' Categoria ' e-Cigarette with a focus on smoking reduction and smoking abstinence . Study participants were invited to attend a total of five study visits : at baseline , week-4 , week-8 , week-12 and week-24 . Product use , number of cigarettes smoked , and exhaled carbon monoxide ( eCO ) levels were measured at each visit . Smoking reduction and abstinence rates were calculated . Adverse events and product preferences were also review ed . Results Sustained 50 % reduction in the number of cig/day at week-24 was shown in 13/40(32.5 % ) participants ; their median of 25 cigs/day decreasing to 6 cigs/day ( p < 0.001 ) . Sustained 80 % reduction was shown in 5/40(12.5 % ) participants ; their median of 30 cigs/day decreasing to 3 cigs/day ( p = 0.043 ) . Sustained smoking abstinence at week-24 was observed in 9/40(22.5 % ) participants , with 6/9 still using the e-Cigarette by the end of the study . Combined sustained 50 % reduction and smoking abstinence was shown in 22/40 ( 55 % ) participants , with an overall 88 % fall in cigs/day . Mouth ( 20.6 % ) and throat ( 32.4 % ) irritation , and dry cough ( 32.4 % ) were common , but diminished substantially by week-24 . Overall , 2 to 3 cartridges/day were used throughout the study . Participants ' perception and acceptance of the product was good . Conclusion The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit ( http:// Clinical Trials.gov number NCT01195597 ) Electronic cigarettes ( e-Cigarette ) are battery-operated devices design ed to vaporise nicotine that may aid smokers to quit or reduce their cigarette consumption . Research on e-Cigarettes is urgently needed to ensure that the decisions of regulators , healthcare providers and consumers are evidence based . Here we assessed long-term effectiveness and tolerability of e-Cigarette used in a ‘ naturalistic ’ setting . This prospect i ve observational study evaluated smoking reduction/abstinence in smokers not intending to quit using an e-Cigarette ( ‘ Categoria ’ ; Arbi Group , Italy ) . After an intervention phase of 6 months , during which e-Cigarette use was provided on a regular basis , cigarettes per day ( cig/day ) and exhaled carbon monoxide ( eCO ) levels were followed up in an observation phase at 18 and 24 months . Efficacy measures included : ( a ) ≥50 % reduction in the number of cig/day from baseline , defined as self-reported reduction in the number of cig/day ( ≥50 % ) compared to baseline ; ( b ) ≥80 % reduction in the number of cig/day from baseline , defined as self-reported reduction in the number of cig/day ( ≥80 % ) compared to baseline ; ( c ) abstinence from smoking , defined as complete self-reported abstinence from tobacco smoking ( together with an eCO concentration of ≤10 ppm ) . Smoking reduction and abstinence rates were computed , and adverse events review ed . Of the 40 subjects , 17 were lost to follow-up at 24 months . A > 50 % reduction in the number of cig/day at 24 months was shown in 11/40 ( 27.5 % ) participants with a median of 24 cig/day use at baseline decreasing significantly to 4 cig/day ( p = 0.003 ) . Smoking abstinence was reported in 5/40 ( 12.5 % ) participants while combined > 50 % reduction and smoking abstinence was observed in 16/40 ( 40 % ) participants at 24 months . Five subjects stopped e-Cigarette use ( and stayed quit ) , three relapsed back to tobacco smoking and four up grade d to more performing products by 24 months . Only some mouth irritation , throat irritation , and dry cough were reported . Withdrawal symptoms were uncommon . Long-term e-Cigarette use can substantially decrease cigarette consumption in smokers not willing to quit and is well tolerated . ( http:// Clinical Trials.govnumberNCT01195597 ) Background Electronic cigarettes ( e-cigarettes or electronic nicotine delivery systems [ ENDS ] ) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and /or glycerol mist to the airway of users when drawing on the mouthpiece . Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device . People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids . However , to date there have been no adequately powered r and omised trials investigating their cessation efficacy or safety . This paper outlines the protocol for this study . Methods / design Design : Parallel group , 3-arm , r and omised controlled trial . Participants : People aged ≥18 years resident in Auckl and , New Zeal and ( NZ ) who want to quit smoking . Intervention : Stratified blocked r and omisation to allocate participants to either Elusion ™ e-cigarettes with nicotine cartridges ( 16 mg ) or with placebo cartridges ( i.e. no nicotine ) , or to nicotine patch ( 21 mg ) alone . Participants r and omised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day , while participants r and omised to patches will be told to use them daily for the same period . All participants will be offered behavioural support to quit from the NZ Quitline . Primary outcome : Biochemically verified ( exhaled carbon monoxide ) continuous abstinence at six months after quit day . Sample size : 657 people ( 292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group ) will provide 80 % power at p = 0.05 to detect an absolute difference of 10 % in abstinence between the nicotine e-cigarette and nicotine patch groups , and 15 % between the nicotine and placebo e-cigarette groups . Discussion This trial will inform international debate and policy on the regulation and availability of e-cigarettes . If shown to be efficacious and safe , these devices could help many smokers as an alternative smoking cessation aid to st and ard nicotine products . Trial registration Australian NZ Clinical Trials Registry ( ACTRN12610000866000 ) Abstract Background Smoking is Australia ’s leading preventable cause of premature mortality and a major contributor to the national disease burden . If quit rates do not dramatically improve , then smoking will continue to be a major public health issue for decades to come . Harm-reduction approaches using novel nicotine products like e-cigarettes as long term replacements for smoking have the potential to improve quit rates . However , little research has assessed such approaches . Methods / Design Design : Three-arm parallel-group pragmatic r and omised controlled trial . Participants : People living in Australia who are at least 18 years old , smoke five or more cigarettes per day and are willing to try a sample of nicotine products . Intervention : Participants are r and omised to receive st and ard quit advice and medicinal nicotine ( Condition A ) ; quit or substitute advice and medicinal nicotine ( Condition B ) ; or quit or substitute advice and medicinal nicotine and e-cigarettes ( Condition C ) . Participants choose which ( if any ) nicotine products to receive to try in a free sample pack followed by a two to three week free supply of their favourite product(s ) and the option to purchase more at a discounted price . Follow-up surveys will assess nicotine product use and smoking . Primary outcome : Continuous abstinence for at least 6 months . Target sample size : 1600 people ( Condition A : 340 ; Condition B : 630 ; Condition C : 630 ) provides at least 80 % power at p = 0.05 to detect a 5 % difference in abstinence rates between each condition . Discussion This trial will provide data on tobacco harm-reduction approaches and in particular the use of e-cigarettes as a replacement for smoking . Trial registration Australian and New Zeal and Clinical Trials Registry : ACTRN12612001210864 . Date of registration : 15/11/2012 In a clinical study , changes in 14 biomarkers of exposures ( BOEs ) from 10 tobacco smoke constituents and mutagens detected by the urine mutagenicity test were investigated using a non-combustion inhaler type of tobacco product ( NCIT ) by switching from a conventional cigarette . This study was conducted in 80 Japanese healthy adult males with a 4-week residential , controlled , open-label , parallel group design . After r and omization , 40 smokers used NCIT with approximately 750 aspirations , other 20 smokers smoked approximately 20 pieces of an assigned 1-mg ISO tar conventional cigarette ( CC1 ) every day . Twenty non-smokers ( NS ) did not use any tobacco product . Under this study condition , switching from cigarette to NCIT showed significant reduction in all BOEs measured . On day 29 , the levels of these BOEs were almost the same as those in the NS group , except BOEs of nicotine and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone ( NNK ) . This suggested that the exposure to 8 constituents and mutagens in the NCIT group was similar to that in the NS group , while the exposure to nicotine was higher . Although the precise exposure level to NNK was not estimated because of the long half-life of its BOE , it would be substantially lower in the NCIT group than in the CC1 group Background While electronic cigarettes are forbidden in several countries , their sales are exploding in many others . Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation , very scarce data are available on their efficacy and safety . We describe the protocol of a 5-year multicentric prospect i ve study aim ed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and /or quitting traditional cigarette smoking . The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking . Methods / design From June to December 2013 , we will enroll adult smokers of : ( EC ) e-cigarettes ( self-reported inhaling ≥ 50 puffs per week since ≥ 6 months ) ; ( TC ) traditional cigarettes ( ≥ 1 per day since ≥ 6 m ) ; ( Mixed ) both electronic and traditional cigarettes ( ≥1 per day since ≥ 6 m ) . Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops . Each subject will have to compile a structured question naire at enrolment and after 6 , 12 , 24 , 36 and 60 months . The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase , using portable carbon monoxide analyzers . The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes . Secondary outcomes include adherence to e-cigarettes , self-reported adverse events , quality of life , and time to hospital admission for one among cardiovascular diseases , chronic obstructive pulmonary diseases , cancer of the lung , esophagus , larynx , oral cavity , bladder , pancreas , kidney , stomach , cervix , and myeloid leukemia . Admissions will be checked using official discharge data of the Abruzzo Region . A minimum of 500 subjects in each group will be enrolled , for a total of 1500 participants . Cox proportional hazards analysis will be used to calculate adjusted relative hazards of smoking cessation by each variable . Discussion Data on long-term efficacy and safety of e-cigarettes will be of utmost importance to form the basis for guidelines and regulatory decisions on e-cigarettes . Trial registration The protocol has been registered ( NCT01785537 ) and approved by the Ethics Committee of the University of Chieti ( Record n. 6 ; 25 - 03 - 2013 ) Background and Aims Electronic cigarettes ( e-cigarettes ) are rapidly increasing in popularity . Two r and omized controlled trials have suggested that e-cigarettes can aid smoking cessation , but there are many factors that could influence their real-world effectiveness . This study aim ed to assess , using an
Output:
| The most frequently reported AEs were mouth and throat irritation , most commonly dissipating over time .
The most commonly reported adverse effects were irritation of the mouth and throat . |
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