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MS212200 | ***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 study was design ed to assess whether a self- study interactive computer program is more effective than weekly seminars for teaching fundamental skills of electrocardiographic interpretation to junior medical students . Forty-two students were assigned to the computer and 41 to the seminar group . A test was given to each participant at the beginning and end of each rotation . The computer group used a computer-assisted learning program , and the seminar group met weekly with a cardiologist to review electrocardiograms . Attendance at a minimum of 80 % of the seminars or completion of 80 % of the computer-assisted learning program was required for inclusion in the statistical analysis . The mean difference in test scores before and after study was 5.69 for the computer group and 4.36 for the seminar group ( P less than .02 by one-tailed t-test ) . These results indicate that the computer group performed significantly better than the seminar group . We believe this difference to be educationally important To examine the effect of clinical history on the electrocardiogram ( ECG ) interpretation skills of physicians with different levels of expertise , we r and omly allocated to an ECG test package 30 final-year medical students , 15 second-year internal medicine residents , and 15 university cardiologists at university-affiliated teaching hospitals . All participants interpreted the same set of 10 ECGs . Each ECG was accompanied by a brief clinical history suggestive of the correct ECG diagnosis , or the most plausible alternative diagnosis , or no history . Provision of a correct history improved accuracy by 4 % to 12 % compared with no history , depending on level of training . Conversely , a misleading history compared with no history reduced accuracy by 5 % for cardiologists , 25 % for residents , and 19 % for students . Clinical history also affected the paticipants ’ frequencies of listing ECG features consistent with the correct diagnosis and features consistent with the alternative diagnosis ( allp values < .05 ) . For physicians at all levels of expertise , clinical history has an influence on ECG diagnostic accuracy , both improving accuracy when the history suggests the correct diagnosis , and reducing accuracy when the history suggests an alternative diagnosis We assessed the performance of diagnostic electrocardiogram ( ECG ) interpretation by the computer program MEANS and by research physicians , compared to cardiologists , in a physician-based study . To establish a strategy for ECG interpretation in health surveys , we also studied the diagnostic capacity of three scenarios : use of the computer program alone ( A ) , computer program and cardiologist ( B ) , and computer program , research physician , and cardiologist ( C ) . A stratified r and om sample of 381 ECGs was drawn from ECGs collected in the Rotterdam Study ( n = 3057 ) , which were interpreted both by a trained research physician using a form for structured clinical evaluation and by MEANS . All ECGs were interpreted independently by two cardiologists ; if they disagreed ( n = 175 ) the ECG was judged by a third cardiologist . Five ECG diagnoses were considered : anterior and inferior myocardial infa rct ion ( MI ) , left and right bundle branch block ( LBBB and RBBB ) , and left ventricular hypertrophy ( LVH ) . Overall , sensitivities and specificities of MEANS and the research physicians were high . The sensitivity of MEANS ranged from 73.8 % to 92.9 % and of the research physician ranged from 71.8 % to 96.9 % . The specificity of MEANS ranged from 97.5 % to 99.8 % and of the research physician from 96.3 % to 99.6 % . To diagnose LVH , LBBB , and RBBB , use of the computer program alone gives satisfactory results . Preferably , all positive findings of anterior and inferior MI by the program should be verified by a cardiologist . We conclude that diagnostic ECG interpretation by computer can be very helpful in population -based research , being at least as good as ECG interpretation by a trained research physician , but much more efficient and therefore less expensive OBJECTIVES To determine whether access to a computer generated electrocardiogram ( ECG ) report can reduce errors of interpretation by senior house officers ( SHOs ) in an accident and emergency department . METHODS Ten SHOs were asked to interpret 50 ECGs each : 25 with computer generated reports , 25 without . Their answers , and the computer generated reports , were compared with a “ gold st and ard ” produced by two experienced clinicians . The primary outcome measure was the proportion of major errors of interpretation . RESULTS The computer reading system made two major errors ( 4 % , 95 % confidence interval ( CI ) 1.1 % to 13.5 % ) compared with the gold st and ard . Access to the computer report did not significantly reduce major errors among SHOs ( 46 ( 18.4 % ) with report v 56 ( 22.4 % ) without , odds ratio 0.64 , 95 % CI 0.36 % to 1.14 % , p=0.13 ) or improve the proportion completely correct ( 104 ( 41.6 % ) with reportv 91 ( 36.4 % ) without , odds ratio 1.43 , 95 % CI 0.88 to 2.33 , p=0.15 ) . CONCLUSIONS SHOs have a high error rate when interpreting ECGs , which is not significantly reduced by access to a computer generated report . Junior doctors should continue to seek expert senior help when they have to interpret a difficult ECG Objective . To evaluate the effect of computer-assisted interpretation of electrocardiograms ( ECGs ) on diagnostic decision making by primary care physicians . Design . R and omized controlled trial . Setting . Primary care physicians ' outpatient clinics in or near the Minneap olis/St . Paul metropolitan area . Participants . Forty family physicians and general internists who were members of either of two large consortia of clinics . Intervention . Subjects evaluated ten clinical vignettes accompanied by ECGs and reported their diagnostic impressions . The vignettes were based on actual patient visits . Half of the subjects received ECGs with computer-generated reports , the other half received the same ECGs without reports . Main outcome measures . ECG reading time ; agreement with the clinical diagnosis ; agreement with the computer report ; diagnostic confidence . Results . The subjects receiving the reports were more likely to agree with the clinical diagnoses of the original cases , particularly for two vignettes in which the diagnoses were uncommon and were mentioned in the reports . The subjects receiving the reports were also more likely to make diagnoses that were consistent with the reports , even when the reports were erroneous . Those receiving the reports spent , on average , 15 seconds less time looking at each ECG , a 25 % decrease . Conclusions . In simulated cases , primary care physicians appear to use computer interpre tations of ECGs when available , as shown by enhanced diagnostic accuracy and modestly reduced time spent reading the tracings . However , erroneous reports may mislead physi cians . Since the effects of computerized ECG interpretation do not appear to have been uniformly favorable in this mock- clinical setting , it will be important to evaluate the effects of this technology in actual practice . Key words : computer-assisted diagnosis ; computer-as sisted decision making ; physician decision making ; electrocardiogram . ( Med Decis Making 1995;15:107 - 112 The present study compares the on-site interpretation of an admission electrocardiogram ( ECG ) with core laboratory results in a large , multicenter trial of 516 patients diagnosed with unstable angina pectoris or non-Q-wave myocardial infa rct ion . The local investigators evaluated the admission ECG regarding ST-T changes before the ECGs were sent to the core laboratory for blinded interpretation . The strength of agreement between the observations was described by kappa statistics . There was a poor agreement regarding identification of ST-segment elevation , with 17 patients identified by the local investigator versus 92 by the core laboratory ( kappa = 0.05 ) . There was a fair agreement on ST-segment depression with 158 patients diagnosed on-site versus 64 by the core laboratory ( kappa = 0.38 ) . Identification of T-wave inversion demonstrated good agreement with 306 patients diagnosed on-site versus 280 by the core laboratory ( kappa = 0.63 ) . A moderate agreement regarding identification of a normal ECG was found with 101 patients on-site versus 135 in the core laboratory ( kappa = 0.42 ) . Independent variables , including peak creatine kinase-MB and 30-day outcome , were more closely related to core laboratory results than the local investigator 's interpretation of the admission ECG . Thus , in the present study , considerable differences were demonstrated between the on-site interpretation of the admission ECG and the blinded evaluation performed in the core laboratory regarding relatively simple electrocardiographic variables . The results suggest that more widespread use of independent evaluation of clinical data should be incorporated in future clinical trials In this study we have examined the ability of senior house officers in the Accident and Emergency ( A&E ) Department to interpret electrocardiographs ( ECGs ) and tested the value of a single seminar and guidelines on interpretation . We prospect ively audited ECG interpretation taken from notes over a two-month period and repeated this audit following a single seminar by a consultant cardiologist and after the issue of guidelines . A formal test of interpretation of a set of 20 ECGs by senior house officers in A&E was also carried out . 245 case notes were review ed and in one third the ECG was interpreted incorrectly by senior house officers in A&E but incorrect clinical management followed in only 3.2 % of cases . Following the intervention , 242 case notes were review ed and serious misinterpretations were halved as was the number of patients mismanaged as a result ( 1.7 % ) . In conclusion , formal training in ECG interpretation can reduce serious errors
Output:
| Advanced Cardiac Life Support programs sponsored by the AHA also provide supplemental instruction and testing on abnormal cardiac rhythm recognition in emergency setting s. Successful completion of residency , board certification , and Advanced Cardiac Life Support training are one reasonable method of objective documentation that a physician is competent to interpret bedside ECGs in routine and emergency setting s , pending additional outcomes -based research .
Cardiologists also demonstrate greater accuracy than noncardiologists in ECG interpretation during st and ardized examinations of ECG interpretation when minimal history is given ( 15 ) . |
MS212201 | ***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 clarify the safety of elective induction of labor at 39 weeks of gestation . STUDY DESIGN Prospect i ve r and omized study . SUBJECTS AND METHODS Uncomplicated nulliparas ( N = 194 ) were r and omly assigned at 36 weeks of gestation . Labor was electively induced in 63 women at 39 weeks of gestation in the active management group ( I group , N = 98 ) . Spontaneous labor onset was expected with semi-weekly nonstress test ( NST ) and amniotic fluid index ( AFI ) by 42 weeks of gestation in the expectant group ( E group , N = 96 ) . Perinatal events were compared between the 2 groups . RESULTS A significantly higher incidence of meconium-stained amnios ( 19.4 % vs 3.2 % ) and fetal resuscitation ( 16.7 % vs 4.8 % ) was found in the E group than in the I group . Also , although a significantly higher incidence of epidural analgesia was noted in the I group ( 89 % ) than in the E group ( 54 % ) ( labor onset > or = 39 weeks , N = 72 ) , the duration of the 1st stage was shorter in I group and the duration of the 2nd stage was not significantly different . No other significant difference was noted between the 2 groups in terms of the rate of C-section , blood loss , incidence of pathological FHR , birth weight , Apgar score , umbilical arterial pH , or admission to NICU . CONCLUSION Active management of labor at 39 weeks could be made as safely as expectant management with modified biophysical profile monitoring A total of 85 women with antepartum fetal death between 14 and 42 weeks gestation was r and omly assigned to one of two regimens of intravenous infusion of the prostagl and in analogue 16‐phenoxy‐17 , 18 , 19 , 20‐tetranor‐PGE2‐methylsulphonamide ( sulprostone ) for inducing labour . Women received either 1 μg/min until delivery or the commonly recommended treatment of 1500 μg in 8 h followed by another , identical course of treatment if delivery did not occur within 24 h. The 1 μg/min dose schedule used half the amount of prostagl and in and result ed in statistically significantly fewer gastrointestinal side‐effects compared with the conventional treatment . All women were delivered vaginally and there were no differences in induction‐to‐delivery intervals between the two treatments . Sulprostone infused at a rate of 1 μg/min result ed in a 50 % chance of being delivered within 12 h and a 90 % chance of being delivered within 24 h , with an overall frequency of side‐effects of 20 % Using a r and omized double-blind research design , the efficacy and safety of intravenous prostagl and in F2a ( PF ) and oxytocin ( O ) for inducing labor were compared in term pregnant women . The results show that successful induction depends upon the condition of the cervix , and for comparable groups there was no difference for PF or O. The PF failures occurred in patients who were significantly more obese . The incidence of uterine hypertonus , hot flashes and vein phlebitis was increased significantly in the PF group but there was no difference in the incidence of fetal bradycardia , nausea , vomiting or diarrhea . The infants delivered vaginally were of similar weight and had similar 1- and 5-minute Apgar scores . Laboratory toxicity studies , before and after infusions ( complete blood count , uric acid , bilirubin , SGOT , and blood urea nitrogen ) , were similar for the two drug groups , except that hemoglobin levels postinfusion were significantly higher in the O group . The incidence of cesarean section was significantly increased in the PF group and these sections were done for uterine hypertonus and /or fetal bradycardia . Caution should be exercised before prostagl and in Fα solutions are used routinely to induce labor at term A comparison has been made between the effectiveness of infusing prostagl and in F2a with Syntocinon for the induction of labour , in the presence of intact membranes A double blind trial of prostagl and in E2 and oxytocin given by intravenous infusion after amniotomy for induction of labour in 100 primigravidae with unfavourable induction features is reported . No clear‐cut advantage of either drug emerged although PGE2was perhaps superior when the cervix was highly unfavourable . Prostagl and in E2appeared to produce less deleterious effects on the fetus but was associated with a higher incidence of maternal side effects . The automatic Cardiff Infusion apparatus was found to be a safe means of PGE2infusion and to have advantages over the use of non‐automatic techniques both for PGE2 and for oxytocin infusion One hundred consecutive women with singleton pregnancies and primary rupture of membranes ( PROM ) after 36 weeks of gestation were included in a prospect i ve , r and omized trial of intravenous infusion of oxytocin ( up to 30 mIU/min ) versus low‐dose prostagl and in F2α(PGF2αup to 6.0 μg/min ) . Cesarean section was performed in 12 patients because of suspected disproportion or intra‐uterine asphyxia . Effective contractions or labor progress failed to become established within 8 hours in another 4 women stimulated with PGF2α and 2 stimulated by oxytocin . The stimulation delivery time ( hours ) for the remaining 82 women treated with PGF2α or oxytocin , respectively was 8.7 against 12.1 for initial Bishop score < 5 ( p<0.01 ) , ( Mann‐Whitney test ) , 7.2 vs. 7.1 for Bishop score 5–8 and 5.7 vs. 4.2 for Bishop score > 8 . Patients with initial Bishop score < 5 seemed to need analgetics less often when treated with PGF2α than with oxytocin . Frequencies of side effects and instrumental deliveries as well as the fetal outcome were similar for the two treatment schedules . The results of the study suggest that low‐dose PGF2α infusion may be the more appropriate treatment for women with an unfavorable initial Bishop score A double-blind study was conducted to determine the effects of prostagl and in F2 alpha on the levels of estriol and progesterone in the peripheral venous blood during term pregnancy and to compare the effects of PGF2 alpha with that produced by oxytocin . 32 multiparous volunteers in the last 4 weeks of pregnancy were r and omly assigned to 1 of 2 groups the first group of 12 women receiving oxytocin for labor induction and the 2nd group of 20 women receiving PGF2 alpha . The subjects in both groups were of comparable age parity . and weight . 3 inductions failed in the oxytocin group compared to 8 in the PGF2 alpha group . As the process of delivery itself may alter plasma steroid levels both groups were further subdivided into those subjects who delivered and those who did not deliver . The data suggest that neither oxytocin nor PGF2 alpha given intravenously to term pregnant women for labor induction significantly altered the plasma levels of estriol or progesterone In a group of 20 matched primigravid patients labour was induced by forewater amniotomy followed by intravenous oxytocin ( Syntocinon ) administered in escalating doses . Ten of these patients , in a double-blind trial , also received prostagl and in E2 infused simultaneously with the oxytocin . In the combined prostagl and in-oxytocin group there was a noticeable reduction in the dosage of oxytocin required to produce effective uterine action , and the duration of labour was also reduced . No side effects were observed PGEM concentration was determined radioimmunologically in a non-pregnant woman in whom PGE2 was infused intravenously at increasing dosage and in women in whom labour was induced by various methods for local application of PGE2 . There was excellent correlation between the amount of PGE2 infused intravenously and the levels of PGEM determined in the peripheral plasma . The following methods of local application of PGE2 were included in the study : 0.4 mg PGE2 gel placed retroamnially by means of a balloon catheter ; 0.4 and 0.5 mg PGE2 gel applied endocervically ; 1.5 mg PGE2 given pericervically through a portio adapter and 3 mg PGE2 placed intravaginally in form of a single vaginal tablet ; also included was a control group where only vaginal examination was performed . Blood was withdrawn before , and then 30 minutes , 1 , 2 and 3 hours after PGE2 administration . Mean levels of PGEM in the maternal peripheral plasma showed no change within or between the various groups , with the exception of one patient in the portio adapter group where hyperstimulation occurred . After removal of the adapter PGEM levels dropped to baseline values . It is concluded from the present study that local application of doses currently used to soften the cervix and /or induce labour at term does not give rise to PGEM concentrations in the maternal blood of the same magnitude as achieved by intravenous PGE2 administration A comparison has been made between the effectiveness of infusing prostagl and in E2 with Syntocinon for the induction of labour in the presence of intact membranes . Rapid titration schedules were used to induce an early uterine response . All 15 subjects receiving prostagl and in E2 achieved cervical dilatation , whereas this occurred in only 9 out of 15 patients receiving Syntocinon Abstract Prostagl and ins E 2 and F 2 α and synthetic oxytocin were studied for efficacy and side effects in a double-blind protocol for the induction of labor at term in 100 women . That an inducibility scoring index should be part of each clinical oxytocin trial is evidence d by the fact that erroneous conclusions would have been drawn if it had not been used . All patients who were classified as having " easy inductions " were delivered independent of which drug they received ; however , the 3 categories of grade d " difficult inductions " reflected success rates from 93.3 to 40 per cent , depending upon difficulty of induction . Synthetic oxytocin and prostagl and in F 2 α were found to be equally efficacious in the difficult groups although more cases will be required to allow significant statistical analysis . Except for an increased incidence of innocuous uterine hypertonus , no significant side effects of prostagl and in infusions were noted A double-blind trial of oxytocin ( Syntocinon ) and prostagl and in E2 ( PGE2 ) in the induction of labor in 300 patients result ed in equally high success rates for both drugs . 73 % of the patients in each group were delivered or achieved a 6 cm dilatation of the cervix within 12 hours of the start of infusion . The patients were not matched for factors known to affect labor and thus no statistical analysis of the results was attempted . In the successful cases there were no maternal complications of treatment . ( authors
Output:
| REVIEW ER 'S CONCLUSIONS Intravenous prostagl and in is no more efficient than intravenous oxytocin for the induction of labour but its use is associated with higher rates of maternal side effects and uterine hyperstimulation than oxytocin .
No conclusions can be drawn form the comparisons of combination of prostagl and in F2 alpha and oxytocin compared to oxytocin alone or extra amniotic and intravenous prostagl and in E2 |
MS212202 | ***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 : The principal objective of the present work was to examine the effects of mind state ( mind-w and ering vs. on-task ) on driving performance in a high-fidelity driving simulator . Background : Mind-w and ering is thought to interfere with goal -directed thought . It is likely , then , that when driving , mind-w and ering might lead to impairments in critical aspects of driving performance . In two experiments , we assess the extent to which mind-w and ering interferes with responsiveness to sudden events , mean velocity , and headway distance . Method : Using a car-following procedure in a high-fidelity driving simulator , participants were probed at r and om times to indicate whether they were on-task at that moment or mind-w and ering . The dependent measures were analyzed based on the participant ’s response to the probe . Results : Compared to when on-task , when mind-w and ering participants showed longer response times to sudden events , drove at a higher velocity , and maintained a shorter headway distance . Conclusion : Collectively , these findings indicate that mind-w and ering affects a broad range of driving responses and may therefore lead to higher crash risk . Application : The results suggest that situations that are likely associated with mind-w and ering ( e.g. , route familiarity ) can impair driving performance Task unrelated thought ( TUT ) refers to thought directed away from the current situation , for example a daydream . Three experiments were conducted on healthy participants , with two broad aims . First , to contrast distributed and encapsulated views of cognition by comparing the encoding of categorical and r and om lists of words ( Experiments One and Two ) . Second , to examine the consequences of experiencing TUT during study on the subsequent retrieval of information ( Experiments One , Two , and Three ) . Experiments One and Two demonstrated lower levels of TUT and higher levels of word-fragment completion whilst encoding categorical relative to r and om stimuli , supporting the role of a distributed re source in the maintenance of TUT . In addition the results of all three experiments suggested that experiencing TUT during study had a measurable effect on subsequent retrieval . TUT was associated with increased frequency of false alarms at retrieval ( Experiment One ) . In the subsequent experiments TUT was associated with no advantage to retrieval based on re collection , by manipulating instructions at encoding ( Experiment Two ) , and /or at retrieval ( Experiment Three ) . The implication s of the results of all three experiments are discussed in terms of recent accounts of memory retrieval and conscious awareness Previous studies have found that mindfulness training reduces overgeneral memories and increases autobiographical memory specificity ( e.g. , [ Williams , J. M. G. , Teasdale , J. D. , Segal , Z. V. , & Soulsby , J. ( 2000 ) . Mindfulness-based cognitive therapy reduces overgeneral autobiographical memory in formerly depressed patients . Journal of Abnormal Psychology , 109 , 150 - 155 ] ) . However , little work has investigated the mechanisms underlying this effect . The present study explored the role of executive processes as a mediator of MBCT effects in an unselected sample . An autobiographical memory task , a cognitive inhibition task , a motor inhibition task , a cognitive flexibility task and a motor flexibility task were administered before and after intervention . Compared to matched controls , MBCT participants showed increased autobiographical memory specificity , decreased overgenerality , and improved cognitive flexibility capacity and capacity to inhibit cognitive prepotent responses . Mediational analyses indicated that changes in cognitive flexibility partially mediate the impact of MBCT on overgeneral memories . Results are discussed in terms of Conway 's [ 2005 . Memory and the self . Journal of Memory and Language , 53 , 594 - 628 ] autobiographical memory model
Output:
| The results of the review suggest that mindfulness may be particularly useful for preventing distracted driving . |
MS212203 | ***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 Oral budesonide 9 mg/day represents first-line treatment of mild-to-moderately active ileocolonic Crohn 's disease . However , there is no precise recommendation for budesonide dosing due to lack of comparative data . A once-daily ( OD ) 9 mg dose may improve adherence and thereby efficacy . METHODS An eight-week , double-blind , double-dummy r and omised trial compared budesonide 9 mg OD versus 3 mg three-times daily ( TID ) in patients with mild-to-moderately active ileocolonic Crohn 's disease . Primary endpoint was clinical remission defined as CDAI < 150 at week 8 ( last observation carried forward ) . RESULTS The final intent-to-treat population comprised 471 patients ( 238 [ 9 mg OD ] , 233 [ 3 mg TID ] ) . The confirmatory population for the primary endpoint analysis was the interim per protocol population ( n=377 ; 188 [ 9 mg OD ] , 189 [ 3 mg TID ] ) , in which the primary endpoint was statistically non-inferior with budesonide 9 mg OD versus 3 mg TID . Clinical remission was achieved in 71.3 % versus 75.1 % , a difference of -3.9 % ( 95 % CI [ -14.6 % ; 6.4 % ] ; p=0.020 for non-inferiority ) . The mean ( SD ) time to remission was 21.9 ( 13.8 ) days versus 21.4 ( 14.6 ) days with budesonide 9 mg OD versus 3 mg TID , respectively . In a sub population of 122 patients with baseline SES-CD ulcer score ≥1 , complete mucosal healing occurred in 32.8 % ( 21/64 ) on 9 mg OD and 41.4 % ( 24/58 ) on 3 mg TID ; deep remission ( mucosal healing and clinical remission ) was observed in 26.6 % ( 17/64 ) and 32.8 % ( 19/58 ) of patients , respectively . Treatment-emergent suspected adverse drug reactions were reported in 4.6 % of 9 mg OD and 4.7 % of 3 mg TID patients . CONCLUSIONS Budesonide at the recommended dose of 9 mg/day can be administered OD without impaired efficacy and safety compared to 3 mg TID dosing in mild-to-moderately active Crohn 's disease BACKGROUND & AIMS Osteoporosis frequently occurs in Crohn 's disease , often because of corticosteroids . Budesonide as controlled release capsules is a locally acting corticosteroid with low systemic bioavailability . We investigated its effects on bone compared with prednisolone . METHODS In 34 international centers , 272 patients with Crohn 's disease involving ileum and /or colon ascendens were r and omized to once daily treatment with budesonide or prednisolone for 2 years at doses adapted to disease activity . One hundred eighty-one corticosteroid-free patients had active disease ( 98 had never received corticosteroids , corticosteroid naive ; 83 had received corticosteroids previously , corticosteroid exposed ) , and 90 had quiescent disease , receiving long-term low doses of corticosteroids , corticosteroid-dependent ; in 1 patient , no efficacy data were obtained . Bone mineral density and fractures were assessed in a double-blinded fashion ; disease activity , side effects , and quality of life were monitored . RESULTS Neither the corticosteroid-free nor the corticosteroid-dependent patients treated with budesonide differed significantly in bone mineral density from those receiving prednisolone . However , corticosteroid-naive patients receiving budesonide had smaller reductions in bone mineral density than those on prednisolone ( mean , -1.04 % vs -3.84 % ; P = .0084 ) . Treatment-emergent corticosteroid side effects were less frequent with budesonide . Efficacy was similar in both groups . CONCLUSIONS Treatment with budesonide is associated with better preserved bone mass compared with prednisolone in only the corticosteroid-naive patients with active ileocecal Crohn 's disease . In both the corticosteroid-free and corticosteroid-dependent groups , budesonide and prednisolone were equally effective for up to 2 years , but budesonide caused fewer corticosteroid side effects BACKGROUND Budesonide is a steroid with low systemic effect and high effectiveness in the treatment of Crohn 's Disease ( CD ) . Beclomethasone dipropionate ( BDP ) is also a steroid with the same systemic effects , but it has been never investigated in CD . MATERIAL / METHODS To evaluate the effectiveness and tolerability of BDP versus budesonide in treating CD , we enrolled 30 consecutive patients affected by mild-to-moderate non-fistulizing , non-obstructive Crohn 's disease ( CDAI < or = 250 ) ( 13 M and 17 F , mean age : 33.4 years , range : 16 - 71 years ) in whom this diagnosis was made for the first time . The patients were r and omly treated for 8 weeks with budesonide 9 mg/day ( group A , 15 patients ) or with BDP 10 mg/day ( group B , 15 patients ) . RESULTS Of group A patients , 13/14 ( on intention to treat ( i-t-t ) : 86.67 % ) showed response to budesonide and 10/14 ( on i-t-t . : 66.66 % ) were in remission after 8 weeks of treatment . In group B patients , 10/14 ( on i-t-t : 66.66 % ) showed response to BDP and 8/14 ( on i-t-t : 53.33 % ) were in remission after 8 weeks of treatment ( p<0.001 ) . Budesonide was also faster in the time to obtain symptomatic remission ( p = n.s . ) and was better in improving IBDQL ( p<0.05 ) . Regarding side effects , two group A patients ( 6.66 % ) and three group B patients ( 10 % ) experienced mild-to-moderate side effects which were transitory and did not require any specific treatment or stopping the treatment . CONCLUSIONS BDP seems to be less effective than budesonide in treating CD , probably due to better the pharmacokinetic properties of budesonide Adalimumab is approved for use in patients with moderate to severe Crohn 's disease ( CD ) or ulcerative colitis ( UC ) who have not achieved disease control with conventional therapies including corticosteroids and /or immunomodulators ( IMM ) BACKGROUND & AIMS The aim of this study was to evaluate the usefulness of short-term infliximab combined with azathioprine ( AZA ) or 6-mercaptopurine ( 6-MP ) in steroid-dependent Crohn 's disease patients . METHODS Patients with active disease despite prednisone given for more than 6 months were eligible and were stratified as follows : the failure stratum consisted of patients receiving AZA/6-MP at a stable dose for more than 6 months , and the naive stratum consisted of patients not treated previously with AZA/6-MP . Patients were r and omized to infliximab 5 mg/kg or placebo at weeks 0 , 2 , and 6 . All patients were treated with AZA/6-MP maintained at a stable dose throughout the 52 weeks of the study . The primary end point was remission off steroids at week 24 . RESULTS Among the 113 enrolled patients ( 55 in the failure stratum ) , 57 were assigned to infliximab . At week 24 , the success rate ( intent-to-treat analysis ) was higher in the infliximab group than in the placebo group ( 57 % vs 29 % ; P = .003 ) ; at weeks 12 and 52 , the corresponding rates were 75 % vs 38 % ( P < .001 ) and 40 % vs 22 % ( P = .04 ) , respectively . In each stratum , the success rate was significantly higher in the infliximab group at weeks 12 and 24 , and a trend was found at week 52 . In the failure stratum , only 27 % of the patients in the infliximab group were still in remission off steroids , compared with 52 % in the naive stratum . Steroid resistance was less common and the cumulative dose of prednisone was lower in the infliximab group . CONCLUSIONS Infliximab plus AZA/6-MP is more effective than AZA/6-MP alone in steroid-dependent Crohn 's disease patients BACKGROUND TNF inhibitors have improved treatment of Crohn 's disease , ulcerative colitis , spondyloarthritis , rheumatoid arthritis , psoriatic arthritis , and chronic plaque psoriasis , but are expensive therapies . The aim of NOR-SWITCH was to examine switching from originator infliximab to the less expensive biosimilar CT-P13 regarding efficacy , safety , and immunogenicity . METHODS The study is a r and omised , non-inferiority , double-blind , phase 4 trial with 52 weeks of follow-up . Adult patients on stable treatment with infliximab originator treated in a hospital setting for at least 6 months were eligible for participation . Patients with informed consent were r and omised in a 1:1 ratio to either continued infliximab originator or to switch to CT-P13 treatment , with unchanged dosing regimen . Data were collected at infusion visits in 40 Norwegian study centres . Patients , assessors , and patient care providers were masked to treatment allocation . The primary endpoint was disease worsening during 52-week follow-up . 394 patients in the primary per- protocol set were needed to show a non-inferiority margin of 15 % , assuming 30 % disease worsening in each group . This trial is registered with Clinical Trials.gov , number NCT02148640 . FINDINGS Between Oct 24 , 2014 , and July 8 , 2015 , 482 patients were enrolled and r and omised ( 241 to infliximab originator , 241 to CT-P13 group ; one patient was excluded from the full analysis and safety set for CT-P13 ) and 408 were included in the per- protocol set ( 202 in the infliximab originator group and 206 in the CT-P13 group ) . 155 ( 32 % ) patients in the full analysis set had Crohn 's disease , 93 ( 19 % ) had ulcerative colitis , 91 ( 19 % ) had spondyloarthritis , 77 ( 16 % ) had rheumatoid arthritis , 30 ( 6 % ) had psoriatic arthritis , and 35 ( 7 % ) had chronic plaque psoriasis . Disease worsening occurred in 53 ( 26 % ) patients in the infliximab originator group and 61 ( 30 % ) patients in the CT-P13 group ( per- protocol set ; adjusted treatment difference -4·4 % , 95 % CI -12·7 to 3·9 ) . The frequency of adverse events was similar between groups ( for serious adverse events , 24 [ 10 % ] for infliximab originator vs 21 [ 9 % ] for CT-P13 ; for overall adverse events , 168 [ 70 % ] vs 164 [ 68 % ] ; and for adverse events leading to discontinuation , nine [ 4 % ] vs eight [ 3 % ] , respectively ) . INTERPRETATION The NOR-SWITCH trial showed that switching from infliximab originator to CT-P13 was not inferior to continued treatment with infliximab originator according to a prespecified non-inferiority margin of 15 % . The study was not powered to show non-inferiority in individual diseases . FUNDING Norwegian Ministry of Health and Care Services Background : Vedolizumab is a gut-selective & agr;4&bgr;7 integrin antagonist for the treatment of moderately to severely active Crohn 's disease ( CD ) . Aims of this study were to characterize the efficacy and safety of vedolizumab induction and maintenance therapy in patients who were naïve to tumor necrosis factor-alpha ( TNF-&agr ; ) antagonist therapy ( TNF-naïve ) or who had discontinued TNF-&agr ; antagonist therapy because of inadequate response ( i.e. , primary nonresponse ) , loss of response , or intolerance ( collectively classified as the TNF-failure population ) . Methods : Post hoc analyses of the efficacy data for 516 TNF-naïve and 960 TNF-failure patients from the GEMINI 2 and GEMINI 3 trials were evaluated at weeks 6 , 10 , and 52 and included clinical remission ( CD Activity Index [ CDAI ] score ⩽150 ) , enhanced clinical response ( ≥100-point decrease from baseline in CDAI score ) , durable clinical remission ( remission at ≥80 % of visits ) , and corticosteroid-free remission . Adverse events were summarized for the TNF-naïve and T
Output:
| Corticosteroid therapies ( including budesonide ) can be used as induction , but not maintenance therapies .
Among immunosuppressants , thiopurines should not be used for induction , but can be used for maintenance therapy for selected low-risk patients .
Parenteral methotrexate was proposed for induction and maintenance therapy in patients with corticosteroid-dependent CD .
Biologic agents , including tumor necrosis factor antagonists , vedolizumab , and ustekinumab , were recommended for patients failed by conventional induction therapies and as maintenance therapy .
The consensus group was unable to clearly define the role of concomitant immunosuppressant therapies in initiation of treatment with a biologic agent . |
MS212204 | ***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 purpose of the present investigation was to compare the analgesic efficacy of flurbiprofen , a nonsteroidal anti-inflammatory drug , which is a phenyl propionic acid derivative , with acetaminophen and placebo in 63 adult out patients with moderate to severe dental pain following periodontal surgery . After surgery was completed under local anesthesia , the patients received under double-blind conditions an envelope containing four tablets of either flurbiprofen 100 mg , acetaminophen 500 mg , or placebo and they were instructed to take one tablet every 6 hours when postoperative pain reached moderate to severe intensity . To determine analgesic efficacy and patients recorded pain intensity on a scale of 0 to 3 . Patients were allowed to remedicate after 1 hour if pain was not reduced . Flurbiprofen was shown to possess an adequate analgesic effect superior to either placebo ( P less than 0.005 ) or acetaminophen ( P less than 0.01 ) in the parameters studied . Our results seem to further support earlier data obtained with the drug in dental patients with postoperative pain after the surgical removal of impacted third molars ; therefore , it is concluded that flurbiprofen used as directed is a new alternative for the proper treatment of pain following periodontal surgery BACKGROUND The purpose of this r and omized double-blind study was to compare the efficacy and safety of propacetamol 2 g ( an i.v . acetaminophen 1 g formulation ) administered as a 2-min bolus injection ( n=50 ) or a 15-min infusion ( n=50 ) with oral acetaminophen 1 g ( n=50 ) or placebo ( n=25 ) for analgesia after third molar surgery in patients with moderate to severe pain after impacted third molar removal . METHODS All patients were evaluated for efficacy during the initial 6 h period after treatment administration ( T(0 ) ) and for safety during the entire week after T(0 ) . RESULTS The onset of analgesia after propacetamol was shorter ( 3 min for bolus administration , 5 min for 15-min infusion ) than after oral acetaminophen ( 11 min ) . Active treatments were significantly better for all parameters ( pain relief , pain intensity , patient 's global evaluation , duration of analgesia ) than placebo ( P<0.05 ) . Adverse events were more frequent after propacetamol , especially pain at the injection site . Propacetamol bolus result ed in a much higher incidence of local adverse events than the infusion ( propacetamol bolus 90 % vs propacetamol infusion 52 % ) with no clinical ly significant benefits in terms of analgesic efficacy . CONCLUSION I.V. propacetamol , administered as a 15-min infusion , is a fast-acting analgesic agent . It is more effective in terms of onset of analgesia than a similar dose of oral acetaminophen 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 a double‐blind , r and omized , single‐dose trial the analgesic contribution of acetaminophen , 1000 mg , and codeine , 60 mg , was determined . The study was a 2 × 2 factorial experiment in which 120 patients suffering from pain as a result of oral surgery rated their pain intensity and pain relief for up to 5 hours after a single dose of one of : 1000 mg acetaminophen , 60 mg codeine , 1000 mg acetaminophen plus 60 mg codeine , or placebo . The factorial analysis showed that both 1000 mg acetaminophen and 60 mg codeine made a statistically significant ( P < 0.05 ) contribution to the analgesic effectiveness of the combination on all measures of efficacy ( sum of pain intensity differences , largest pain intensity difference , total pain relief , largest pain relief , and time to remedication ) . The incidence of adverse effects did not appear to differ among the treatments , including placebo To determine the relative analgesic efficacy of ibuprofen 400 mg and acetaminophen 1000 mg , we conducted a single-dose , double-blind , placebo-controlled , r and omized clinical trial using a st and ard assay for analgesic agents , the dental pain model . At regular intervals over 6 hours , 184 patients who had undergone dental impaction surgery rated pain intensity and relief on categorical scales and pain half-gone on a dichotomous nominal scale ; a categorical overall evaluation was completed at the end of 6 hours . Both active agents were effective compared to placebo . Ibuprofen 400 mg was more effective than acetaminophen 1000 mg for Sum Pain Intensity Difference ( SPID ) , Total Pain Relief ( TOTPAR ) , sum pain half-gone , and overall evaluation ( P less than .05 to P less than .001 ) . The time-effect curves demonstrated a greater peak effect and longer duration of action for ibuprofen 400 mg compared to acetaminophen 1000 mg . Side effects were reported in five ibuprofen patients , 11 acetaminophen-treated patients , and seven placebo patients . Based on the results of this clinical study , we conclude that ibuprofen 400 mg is a safe and more effective analgesic than acetaminophen 1000 mg for patients with acute pain A double-blind , placebo-controlled trial was carried out in 299 patients suffering from post-episiotomy pain to compare the analgesic effectiveness and tolerance of single doses of 500 mg dipyrone and 500 mg paracetamol . Assessment s of pain relief over a 6-hour period showed that dipyrone produced significantly better results than placebo within half an hour of intake and maintained this superiority throughout the 6 hours . It also afforded consistently better pain relief than paracetamol and was significantly more effective at the 6-hour assessment . Side-effects were few and mild Lysine clonixinate ( LC ) , an effective and well tolerated non-morphinic analgesic whose mechanism of action is basically due to the inhibition of cyclo-oxygenase , was assessed with a double-blind r and omized dummy design versus paracetamol ( P ) on 200 patients suffering from pain after minor dental surgery . Patients received according to their needs 1 or 2 tablets of 125 mg lysine clonixinate or 500 mg paracetamol every 8 h during 48 h or until pain relief . Both groups , each composed of 100 patients , were comparable in terms of demographic conditions ( t test ) , initial symptoms ( chi-square test ) , characteristics of the extracted dental pieces , surgical complications and wound treatment ( chi-square test ) . Pain intensity scores and daily average intake of tablets ( 3.4/day ) documented in the patients ' diary revealed no statistically significant differences between the two treatments ( chi-square test ) . It was found that spontaneous pain measured using a visual analogue scale ( VAS ) decreased significantly in both treatment groups at the 24-h control examination . The following values were observed in the LC group : baseline 4.38 + /- 1.7 ; 24-h * 1.20 + /- 1.4 ; 48-h * 0.36 + /- 1.2 . In the P group the values were : baseline 4.28 + /- 1.6 ; 24-h * 1.11 + /- 1.4 ; 48-h * 0.30 + /- 0.7 ( * p < 0.05 ) . Other variables like facial swelling and night pain , evaluated on a score from 0 to 4 and symptom presence or absence respectively , showed a similar response . ( ABSTRACT TRUNCATED AT 250 WORDS Background : A r and omized , double‐blind , placebo‐controlled single oral dose study was done in order to examine whether codeine has an additive analgesic effect to that of paracetamol for moderate and strong postoperative pain after abdominal surgery . The maximum recommended single dose of paracetamol 1000 mg ( Paracet ® ) was compared with a combination of a submnximal dose of paracetamol 800 mg plus codeine 60 mg ( Paralgin forte ® ) and placebo for pain relief after Caesarean section in 125 patients 1 Dipyrone 1.0 g , paracetamol 1.0 g and placebo were compared in a double-blind parallel group study in patients with episiotomy pain . 2 Patients were stratified according to severity of initial pain ( severe or moderate ) and the three treatments were r and omized for each of these two groups . 3 Two-hundred and sixty-four patients entered the study : five patients were excluded from analysis ; 127 patients had ' severe ' pain , 132 ' moderate ' pain . 4 Both drugs were more effective than placebo , and dipyrone was significantly more effective than paracetamol , particularly where initial pain was severe . 5 The efficacy of dipyrone 1.0 g was compared with paracetamol 1.0 g in relieving pain after tooth extraction . 6 Ninety patients entered the study and 87 were analyzed without stratification according to initial pain severity . 7 Dipyrone was consistently and significantly more effective than paracetamol at every assessment & NA ; There is uncertainty over whether the patient group in which acute pain studies are conducted ( pain model ) has any influence on the estimate of analgesic efficacy . Data from four recently up date d systematic review s of aspirin 600/650 mg , paracetamol 600/650 mg , paracetamol 1000 mg and ibuprofen 400 mg were used to investigate the influence of pain model . Area under the pain relief versus time curve equivalent to at least 50 % maximum pain relief over 6 h was used as the outcome measure . Event rates with treatment and placebo , and relative benefit ( RB ) and number needed to treat ( NNT ) were used as outputs from the meta‐analyses . The event rate with placebo was systematic ally statistically lower for dental than postsurgical pain for all four treatments . Event rates with analgesics , RB and NNT were infrequently different between the pain models . Systematic difference in the estimate of analgesic efficacy between dental and postsurgical pain models remains unproven , and , on balance , no major difference is likely The efficacy of diclofenac sodium ( Voltarol ) with and without paracetamol in the control of post-surgical dental Summary Acetylsalicylic acid(ASA ) was compared with paracetamol(P ) in a double-blind crossover study , in which essentially the same operation was performed on two separate occasions in 32 healthy patients , who required surgical removal of bilateral “ identically ” impacted wisdom teeth . Sixteen patients were given the drugsboth before and after(b & a-group ) the operations ( 0.5 g on the pre-operative evening , followed by 0.5 g × 4 for 3 days ) ; the other 16 patients did not start treatment until 2 hoursafter(a-group ) the operations . A number of objective and subjective factors were assessed , including swelling , bleeding , pain and preference , and were used to make comparisons of the pre- , per- and post-operative courses . About 50 % greater post-operative swelling was associated withASA compared toP , either if medication was begun prior to surgery or if the drugs were given only after operation . In theb & a-group , interference with platelet function and prolonged pre-operative bleeding time were produced byASA ( 8.9 vs 6.5 min ) , but the per-operative blood loss was not significantly increased ( 7.8 vs 7.4 ml ) . In both groupsASA tended to increase post-operative bleeding and the formation of ha
Output:
| Reported adverse events were mainly mild and transient , and occurred at similar rates with 1000 mg paracetamol and placebo .
A single dose of paracetamol provides effective analgesia for about half of patients with acute postoperative pain , for a period of about four hours , and is associated with few , mainly mild , adverse events |
MS212205 | ***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 sensitivity of H. Pylori to antibiotic treatment is well known . Politherapy ( omeprazole or pantoprazole or ranitidine , amoxicillin and /or azithromycin and /or clarithromycin , metronidazole and bismuth citrate ) notably changed the percentage of H. pylori eradication but rarely resolutive . Periodontal pockets treatment with topic metronidazole , calcium sulphate and potassium sulphate result ed active against bacteria included in periodontal pockets leading to a long-term H. pylori eradication ( two years follow-up ) Background and Aims Helicobacter pylori ( H. pylori ) is an important pathogen in gastritis , peptic ulcer and possibly gastric cancer , but several questions remain unanswered . Particularly how the organism is transmitted and what is the relationship between oral presence of H. pylori and the gastric infection . Accordingly , we aim ed to characterize the H. pylori in oral cavity and to evaluate its relationship to gastric H. pylori infection . Material s and Methods Out of total 100 screened for H. pylori infection female subjects ( 40 to 85 y ) , 49 patients ( pts ) , who had positive 13C-urea breath test ( UBT ) and dyspeptic symptoms , agreed for 1 week regimen of triple anti-H. pylori therapy . The presence of H. pylori in oral cavity was assessed using bacterial culture from saliva and gingival pockets . Gastric H. pylori infection was estimated using capsulated 13C-urea breath test and plasma anti-H. pylori IgG and saliva IgA antibodies . In addition , plasma gastrin , ghrelin , and pepsinogen I were measured by radioimmunoassay . In selected patients , gastroscopy was additionally performed and gastric biopsy sample s were taken for H. pylori r and om amplification of polymorphic DNA genetic profiling . Results The triple therapy result ed in gastric H. pylori eradication in 79 % pts , along with significant decrease of plasma gastrin combined with an increase in plasma ghrelin and pepsinogen I ( PgI ) levels and a marked alleviation of dyspeptic symptoms . In contrast to gastric effects , the eradication therapy failed to cause any changes in the presence of H. pylori in oral cavity . Moreover no relationship was observed between the presence of H. pylori in oral cavity and the gastric H. pylori eradication . In line with these findings , no relationship between gastric and oral H. pylori was found using genetic profiling by r and om amplification of polymorphic DNA . Conclusions H. pylori was detected both in the oral cavity and the stomach but oral H. pylori had no relation to gastric H. pylori and remained unaffected by eradication of gastric H. pylori This study was design ed to compare differentprimer sets for PCR analysis of H. pylori in the sameseries of 40 dental plaque sample s. Three pairs ofprimers , HPU1/HPU2 , HP1/HP2 , and EHC-U/EHC-L , directed to the urease A gene , 16S rRNA gene , or 860-bpDNA of H. pylori , respectively , were used . Our results demonstrate that EHC-L/EHC-U were moRespecific and sensitive for H. pylori added to saliva or dental plaque than HPU1/HPU2 and HP1/HP2 . Thedetection rates for H. pylori DNA in dental plaque sample s from r and omly selected adult patients from theDental Clinic of the University of Ulm were 26.5 % ( 9/34 ) for HPU1/HPU2 , 78.9 % ( 30/38 ) for HP1/HP2 , and 100 % ( 40/40 ) for EHC-U/EHC-L ( P < 0.001 ) . Nested PCRusing primers directed to the 860-bp DNA of H. pylorifurThe r confirmed the presence of H. pylori DNA ( 40/40 ) in all these sample s. Our results indicate that primers EHC-U/EHC-L are to be recommendedfor PCR detection of H. pylori in the oralcavity BACKGROUND Two triple therapies with lansoprazole (LPZ)/amoxicillin (AMPC)/clarithromycin ( CAM ) for eradication of Helicobacter pylori were studied in multicenter , double-blind fashion to evaluate the eradication rate of H. pylori and safety of eradiation treatment in Japanese patients with H. pylori-positive active gastric ulcers or duodenal ulcers . METHODS Patients were r and omly chosen for the control treatment of LPZ 30 mg twice a day ( b.i.d . ; Group A-LPZ-only ) or the test treatments of LPZ 30 mg plus AMPC 750 mg and CAM 200 mg b.i.d . ( Group B-LAC200 ) and LPZ 30 mg , AMPC 750 mg and CAM 400 mg b.i.d . ( Group C-LAC400 ) . All eradication treatments lasted for a period of 7 days . Successful eradication was assessed by culture and gastric histology 1 month after completion of the ulcer treatment . RESULTS The eradication rates of H. pylori in the full analysis set were 0 % in Group A-LPZ-only , 87.5 % in Group B-LAC200 and 89.2 % in Group C-LAC400 for gastric ulcer and , 4.4 % in Group A-LPZ-only , 91.1 % in Group B-LAC200 and 83.7 % in Group C-LAC400 for duodenal ulcer . The eradication rates of Group B-LAC200 and Group C-LAC400 were 89.2 % ( 95 % CI : 84.8 - 93.7 % ) and 86.4 % ( 95%CI : 81.5 - 91.3 % ) in total in the full analysis set , 89 % ( 95 % CI : 84.3 - 93.7 % ) and 85.3 % ( 95%CI : 80.1 - 90.5 % ) in the per protocol set . The eradication rates in Groups B-LAC200 and group C-LAC400 were statistically significantly higher than the rate in Group A-LPZ-only for both gastric ulcer and duodenal ulcer patients ( p < .0001 for both ) . CONCLUSION A satisfactorily high H. pylori eradication rate was obtained in Japanese ulcer patients with the triple therapy regimen consisting of LPZ 30 mg , AMPC 750 mg , and CAM 200 mg b.i.d OBJECTIVE To determine whether antimicrobial therapy for Helicobacter pylori infection accelerates the healing of duodenal ulcers . DESIGN Single-blind , r and omized , controlled trial . SETTING Veterans Affairs hospital . PARTICIPANTS One hundred and five patients with endoscopically verified duodenal ulcers . INTERVENTION Patients received either ranitidine , 300 mg/d , or ranitidine , 300 mg/d , plus " triple therapy " ( 2 g/d of tetracycline , 750 mg/d of metronidazole , and 5 or 8 bismuth subsalicylate tablets per day ) . Triple therapy was administered for only the first 2 weeks of ulcer treatment . MEASUREMENTS Videoendoscopic assessment of ulcer status was done until ulcer healing was complete . Evaluations were done after 2 , 4 , 8 , 12 , and 16 weeks of therapy . MAIN RESULTS Ulcer healing was more rapid in patients receiving ranitidine plus triple therapy than in patients receiving ranitidine alone ( P less than 0.01 ) . The cumulative percentages of patients with healed ulcers in the group receiving ranitidine plus triple therapy and in the group receiving ranitidine alone were as follows : 37 % and 18 % after week 2 ; 74 % and 53 % after week 4 ; 84 % and 68 % after week 8 ; 96 % and 80 % after week 12 ; and 98 % and 84 % after week 16 . CONCLUSION Combined therapy with anti-H. pylori agents and ranitidine was superior to ranitidine alone for duodenal ulcer healing . Our results indicate that H. pylori plays a role in duodenal ulcer disease BACKGROUND The goal of this study was to see whether Helicobacter pylori ( H. pylori ) in the oral cavity might adversely affect the outcome of eradication therapy for gastric H. pylori . MATERIAL S AND METHODS Forty-seven patients ( 36 males , 11 females ) with gastric H. pylori infection were enrolled in this study . Gastric H. pylori infection was confirmed by both immunohistological staining with anti-H. pylori antibody and bacterial culture of biopsy specimens . The therapeutic regimen consisted of 30 mg/day lansoprazole , 750 mg/day metronidazole , and 400 mg/day clarithromycin administered for 2 weeks . A fragment of the H. pylori urease gene was amplified by nested PCR for DNA extracted from saliva and dental plaque from the same patients . We examined the correlation between the gastric eradication success rate and the prevalence of H. pylori in the oral cavity as determined by PCR before and after the eradication therapy . RESULTS The eradication success rate was significantly lower in the oral H. pylori-positive cases ( 12/23 , 52.1 % ) than in the negative cases ( 22/24 , 91.6 % ) at 4 weeks after the therapy ( p = . 0028 ) . Two years later , only 16 of the 23 ( 69.5 % ) oral H. pylori-positive cases were disease-free , as compared to 23 of the 24 ( 95.8 % ) oral H. pylori-negative cases ( p = .018 ) . CONCLUSIONS H. pylori in the oral cavity affected the outcome of eradication therapy and was associated with a recurrence of gastric infection . We recommend that oral H. pylori should be examined by nested PCR and , if positive , should be considered a causal factor in refractory or recurrent cases BACKGROUND Helicobacter pylori eradication from the oral cavity is more difficult than from the stomach . Thus , if the bacterium survives the antibacterial therapy in the oral cavity , it would be able to re-infect the stomach within a few weeks . Since oral health status could correspond to oral infection with H. pylori , the aim of the study was to determine whether oral health and oral hygiene practice s affect the efficacy of H. pylori eradication from the stomach . MATERIAL AND METHODS The study was performed in 137 patients with peptic ulcer who had undergone a 7-day course of eradication treatment with one of two sets of drugs : 1 , omeprazole , amoxicillin , and tinidazole or 2 , omeprazole , clarithromycin , and tinidazole . The efficacy of H. pylori eradication from the stomach was evaluated at the second gastroscopy 4 weeks after cessation of eradication therapy by means of two methods : rapid urease test and histology . The examination of natural dentition and prosthetic restorations as well as the assessment of hygienic procedures referring to natural dentition and dentures accompanied the second gastroscopy . RESULTS No association was found between the efficacy of H. pylori eradication from the stomach and the number of natural teeth , decayed teeth , use of dentures , debris index , or periodontal index . However , an association between eradication success and some oral hygiene procedures were noted . Unexpectedly , in patients treated with omeprazole , amoxicillin and tinidazole , the removal of dental prosthesis for the night and brushing the natural teeth twice a day or more reduced the efficacy of H. pylori eradication from the stomach . CONCLUSIONS Oral health and oral hygiene practice s seem unlikely to increase the efficacy of H. pylori eradication from the stomach
Output:
| In addition , periodontal therapy also had benefits on long-term gastric H. pylori eradication .
AUTHORS ' CONCLUSIONS Overall , periodontal therapy could increase the efficiency of H. pylori eradication and the non-recurrence rate of gastricH. pylori . |
MS212206 | ***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: Enhanced recovery following physical activity and exercise-induced muscle damage ( EIMD ) has become a priority for athletes . Consequently , a number of post-exercise recovery strategies are used , often without scientific evidence of their benefits . Within this framework , the purpose of this study was to test the efficacy of whole body cryotherapy ( WBC ) , far infrared ( FIR ) or passive ( PAS ) modalities in hastening muscular recovery within the 48 hours after a simulated trail running race . In 3 non-adjoining weeks , 9 well-trained runners performed 3 repetitions of a simulated trail run on a motorized treadmill , design ed to induce muscle damage . Immediately ( post ) , post 24 h , and post 48 h after exercise , all participants tested three different recovery modalities ( WBC , FIR , PAS ) in a r and om order over the three separate weeks . Markers of muscle damage ( maximal isometric muscle strength , plasma creatine kinase [ CK ] activity and perceived sensations [ i.e. pain , tiredness , well-being ] ) were recorded before , immediately after ( post ) , post 1 h , post 24 h , and post 48 h after exercise . In all testing sessions , the simulated 48 min trail run induced a similar , significant amount of muscle damage . Maximal muscle strength and perceived sensations were recovered after the first WBC session ( post 1 h ) , while recovery took 24 h with FIR , and was not attained through the PAS recovery modality . No differences in plasma CK activity were recorded between conditions . Three WBC sessions performed within the 48 hours after a damaging running exercise accelerate recovery from EIMD to a greater extent than FIR or PAS modalities The aim of this study was to investigate whether post-exercise vitamin C supplementation influences recovery from an unaccustomed bout of exercise . Sixteen male subjects were allocated to either a placebo ( P ; n=8 ) or vitamin C ( VC ) group ( n=8 ) . Subjects performed a prolonged ( 90-min ) intermittent shuttle-running test , and supplementation began after the cessation of exercise . Immediately after exercise the VC group consumed 200 mg of VC dissolved in a 500 ml drink , whereas the subjects in the P group consumed the drink alone . Later on the same day and then in the morning and evening of the following 2 days , subjects consumed additional identical drinks . Plasma VC concentrations in the VC group increased above those in the P group 1 h after exercise and remained above P values for the 3 days after exercise . Nevertheless , post-exercise VC supplementation was not associated with improved recovery . Post-exercise serum creatine kinase activities and myoglobin concentrations were unaffected by supplementation . Muscle soreness and the recovery of muscle function in the leg flexors and extensors were not different in VC and P groups . Furthermore , although plasma concentrations of interleukin-6 and malondialdehyde increased following exercise , there was no difference between VC and P groups . These results suggest that either free radicals are not involved in delaying the recovery process following a bout of unaccustomed exercise , or that the consumption of VC wholly after exercise is unable to deliver this antioxidant to the appropriate sites with sufficient expediency to improve recovery PURPOSE The authors investigated the efficacy of a single exposure to 14 min of cold-water immersion ( COLD ) and contrast water therapy ( CWT ) on posttraining recovery in Australian football ( AF ) . METHOD Fourteen AF players participated in 3 wk of st and ardized training . After week 1 training , all players completed a passive recovery ( PAS ) . During week 2 , COLD or CWT was r and omly assigned . Players undertook the opposing intervention in week 3 . Repeat-sprint ability ( 6 × 20 m ) , countermovement and squat jumps , perceived muscle soreness , and fatigue were measured pretraining and over 48 h posttraining . RESULTS Immediately posttraining , groups exhibited similar performance and psychometric declines . At 24 h , repeat-sprint time had deteriorated by 4.1 % for PAS and 1.0 % for CWT but was fully restored by COLD ( 0.0 % ) . At 24 and 48 h , both COLD and CWT attenuated changes in mean muscle soreness , with COLD ( 0.6 ± 0.6 and 0.0 ± 0.4 ) more effective than CWT ( 1.9 ± 0.7 and 1.0 ± 0.7 ) and PAS having minimal effect ( 5.5 ± 0.6 and 4.0 ± 0.5 ) . Similarly , after 24 and 48 h , COLD and CWT both effectively reduced changes in perceived fatigue , with COLD ( 0.6 ± 0.6 and 0.0 ± 0.6 ) being more successful than CWT ( 0.8 ± 0.6 and 0.7 ± 0.6 ) and PAS having the smallest effect ( 2.2 ± 0.8 and 2.4 ± 0.6 ) . CONCLUSIONS AF training can result in prolonged physical and psychometric deficits persisting for up to 48 h. For restoring physical-performance and psychometric measures , COLD was more effective than CWT , with PAS being the least effective . Based on these results the authors recommend that 14 min of COLD be used after AF training The objectives of the present investigation was to analyze the effect of two different recovery modalities on classical markers of exercise-induced muscle damage ( EIMD ) and inflammation obtained after a simulated trail running race . Endurance trained males ( n = 11 ) completed two experimental trials separated by 1 month in a r and omized crossover design ; one trial involved passive recovery ( PAS ) , the other a specific whole body cryotherapy ( WBC ) for 96 h post-exercise ( repeated each day ) . For each trial , subjects performed a 48 min running treadmill exercise followed by PAS or WBC . The Interleukin ( IL ) -1 ( IL-1 ) , IL-6 , IL-10 , tumor necrosis factor alpha ( TNF-α ) , protein C-reactive ( CRP ) and white blood cells count were measured at rest , immediately post-exercise , and at 24 , 48 , 72 , 96 h in post-exercise recovery . A significant time effect was observed to characterize an inflammatory state ( Pre vs. Post ) following the exercise bout in all conditions ( p<0.05 ) . Indeed , IL-1β ( Post 1 h ) and CRP ( Post 24 h ) levels decreased and IL-1ra ( Post 1 h ) increased following WBC when compared to PAS . In WBC condition ( p<0.05 ) , TNF-α , IL-10 and IL-6 remain unchanged compared to PAS condition . Overall , the results indicated that the WBC was effective in reducing the inflammatory process . These results may be explained by vasoconstriction at muscular level , and both the decrease in cytokines activity pro-inflammatory , and increase in cytokines anti-inflammatory The aim of this investigation was to eluci date the efficacy of repeated cold water immersions ( CWI ) in the recovery of exercise induced muscle damage . A r and omised group consisting of eighteen males , mean ± s age , height and body mass were 24 ± 5 years , 1.82 ± 0.06 m and 85.7 ± 16.6 kg respectively , completed a bout of 100 drop jumps . Following the bout of damaging exercise , participants were r and omly but equally assigned to either a 12 min CWI ( 15 ± 1 ° C ; n = 9 ) group who experienced immersions immediately post-exercise and every 24 h thereafter for the following 3 days , or a control group ( no treatment ; n = 9 ) . Maximal voluntary contraction ( MVC ) of the knee extensors , creatine kinase activity ( CK ) , muscle soreness ( DOMS ) , range of motion ( ROM ) and limb girth were measured pre-exercise and then for the following 96 h at 24 h increments . In addition MVC was also recorded immediately post-exercise . Significant time effects were seen for MVC , CK , DOMS and limb girth ( p < 0.05 ) indicating muscle damage was evident , however there was no group effect or interaction observed showing that CWI did not attenuate any of the dependent variables ( p > 0.05 ) . These results suggest that repeated CWI do not enhance recovery from a bout of damaging eccentric contractions . Key pointsCryotherapy , particularly cold water immersions are one of the most common interventions used in order to enhance recovery post-exercise . There is little empirical evidence demonstrating benefits from cold water immersions . Research evidence is equivocal , probably due to method ological inconsistencies . Our results show that the cryotherapy administered did not attenuate any markers of EIMD or enhance the recovery of function . We conclude that repeated cold water immersions are ineffective in the recovery from heavy plyometric exercise and suggest athletes and coaches should use caution before using this intervention as a recovery strategy OBJECTIVE Contrast therapy has a long history of use in sports medicine . Edema and ecchymosis reduction , vasodilation and vasoconstriction of blood vessels , blood flow changes , and influences on the inflammatory response are physiologic effects attributed to the ability of this modality to evoke tissue temperature fluctuations . Our purpose was to measure the change in human gastrocnemius intramuscular tissue temperature during a typical contrast therapy treatment . DESIGN AND SETTING A r and omized-group design was used to examine differences between 2 groups of subjects following a 31-minute warm whirlpool ( control ) and a 31-minute contrast therapy ( experimental ) treatment . A hydrotherapy room in a small- college sports medicine facility served as the test environment . SUBJECTS Twenty ( 7 females and 13 males ) healthy college students ( age = 20.9 + /- 1.2 years ; ht = 178.5 + /- 11.1 cm ; wt = 79.2 + /- 21.7 kg ) volunteered to participate in this study . Subjects were r and omly assigned to either a control or a treatment group . MEASUREMENTS Intramuscular tissue temperatures in the gastrocnemius were recorded every 30 seconds . RESULTS There was a significant difference in mean overall temperature change between the experimental group ( 0.85 degrees C + /- 0.60 degrees C ) and the control group ( 2.10 degrees C + /- 1.50 degrees C ) . In addition , there were significant differences between the 2 groups at 10 , 15 , 16 , 20 , 21 , 25 , 26 , 30 , and 31 minutes . At each recording point , the control group temperature change was significantly higher than that of the experimental group . There was no difference in absolute temperatures at the 11-minute recording point between the groups . CONCLUSIONS Contrast therapy did not lead to significant fluctuations in muscle tissue temperature at 4 cm below the skin 's surface . Therefore , it seems unlikely that the physiologic effects attributed to these fluctuations occur . A 1-minute exposure to a cold whirlpool during a typical contrast treatment does not appear to be long enough to significantly decrease tissue temperature after exposure to the warm hydrotherapy environment Kinugasa , T and Kilding , AE . A comparison of post-match recovery strategies in youth soccer players . J Strength Cond Res 23(5 ) : 1402 - 1407 , 2009-The aim of this study was to determine the effect of 3 post-match recovery modalities on physical performance , physiological measures , and players ' perceptions of recovery after 90-minute soccer match play . On separate days , 28 young ( age : 14.3 ± 0.7 years ) soccer players played 3 soccer matches each r and omly followed by 1 of 3 recovery modalities : ( a ) CONT-cold ( 12 ° C ) water immersion and hot ( 38 ° C ) shower , ( b ) COMB-cold water immersion and active recovery using a cycle ergometer , and ( c ) PASS-a passive post-match routine ( stretching and leg raise ) . Performance ( vertical jump height ) , physiological ( heart rate and tympanic temperature ) , and perceptual measures ( perceived quality of recovery ) were determined before each match , 10 minutes after each match , after each recovery method , and after 24 hours . There was a 0.6 ± 6.7 % drop in immediately after a match , but there was no difference in vertical jump height after 24 hours ( p = 0.997 ) . Perceived quality of recovery immediately after COMB was substantially higher than CONT and PASS , but the effect did not last more than 24 hours . The players perceived lighter legs after COMB , compared with the PASS , at post-24 hours . In conclusion , a combined recovery modality ( cold water immersion and active recovery ) after a soccer match did not have a substantial effect on vertical jump height performance when compared with contrast water immersion and passive recovery alone . However , the observed positive effects on perceived recovery ( higher quality of recovery and lighter legs ) after the combined modality ( cold water immersion and active recovery ) suggest that this approach may be effective for young players after intense soccer match play Cryotherapy is an effective treatment for acute sports injury to soft tissue , although the effect of cryotherapy on exercise-induced muscle damage is unclear . The aim of this study was to assess the effects of cold water immersion on the symptoms of exercise-induced muscle damage following strenuous eccentric exercise . After performing a bout of damage-inducing eccentric exercise ( eight sets of five maximal reciprocal contractions at 0.58 rad x s(-1 ) ) of the elbow flexors on an isokinetic dynamometer , 15 females aged 22.0+/-2.0 years ( mean + /- s ) were allocated to a control group ( no treatment , n = 7 ) or a cryotherapy group ( n =
Output:
| Pooled data also showed that CWT significantly reduced muscle strength loss at each follow-up time ( < 6 , 24 , 48 , 72 and 96 hours ) in comparison to passive recovery .
Despite comparing CWT to a large number of other recovery interventions , including cold water immersion , warm water immersion , compression , active recovery and stretching , there was little evidence for a superior treatment intervention .
The current evidence base shows that CWT is superior to using passive recovery or rest after exercise ; the magnitudes of these effects may be most relevant to an elite sporting population .
There seems to be little difference in recovery outcome between CWT and other popular recovery interventions |
MS212207 | ***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 effects of simultaneous explosive-strength and endurance training on physical performance characteristics , 10 experimental ( E ) and 8 control ( C ) endurance athletes trained for 9 wk . The total training volume was kept the same in both groups , but 32 % of training in E and 3 % in C was replaced by explosive-type strength training . A 5-km time trial ( 5 K ) , running economy ( RE ) , maximal 20-m speed ( V20 m ) , and 5-jump ( 5J ) tests were measured on a track . Maximal anaerobic ( MART ) and aerobic treadmill running tests were used to determine maximal velocity in the MART ( VMART ) and maximal oxygen uptake ( VO2 max ) . The 5 K time , RE , and VMART improved ( P < 0.05 ) in E , but no changes were observed in C. V20 m and 5J increased in E ( P < 0.01 ) and decreased in C ( P < 0.05 ) . VO2 max increased in C ( P < 0.05 ) , but no changes were observed in E. In the pooled data , the changes in the 5 K velocity during 9 wk of training correlated ( P < 0.05 ) with the changes in RE [ O2 uptake ( r = -0.54 ) ] and VMART ( r = 0.55 ) . In conclusion , the present simultaneous explosive-strength and endurance training improved the 5 K time in well-trained endurance athletes without changes in their VO2 max . This improvement was due to improved neuromuscular characteristics that were transferred into improved VMART and running economy Fifteen highly trained distance runners ( & OV0312;O2max 71.1 ± 6.0 ml·min−1·kg−1 , mean ± SD ) were r and omly assigned to a plyometric training ( PLY ; n = 7 ) or control ( CON ; n = 8) group . In addition to their normal training , the PLY group undertook 3 × 30 minutes PLY sessions per week for 9 weeks . Running economy ( RE ) was assessed during 3 × 4 minute treadmill runs ( 14 , 16 , and 18 km·h−1 ) , followed by an incremental test to measure & OV0312;O2max . Muscle power characteristics were assessed on a portable , unidirectional ground reaction force plate . Compared with CON , PLY improved RE at 18 km·h−1 ( 4.1 % , p = 0.02 ) , but not at 14 or 16 km·h−1 . This was accompanied by trends for increased average power during a 5-jump plyometric test ( 15 % , p = 0.11 ) , a shorter time to reach maximal dynamic strength during a strength quality assessment test ( 14 % , p = 0.09 ) , and a lower & OV0312;O2-speed slope ( 14 % , p = 0.12 ) after 9 weeks of PLY . There were no significant differences in cardiorespiratory measures or & OV0312;O2max as a result of PLY . In a group of highly-trained distance runners , 9 weeks of PLY improved RE , with likely mechanisms residing in the muscle , or alternatively by improving running mechanics The purpose of this study was to determine if changes in triceps-surae tendon stiffness ( TST K ) could affect running economy ( RE ) in highly trained distance runners . The intent was to induce increased TST K in a subgroup of runners by an added isometric training program . If TST K is a primary determinant of RE , then the energy cost of running ( EC ) should decrease in the trained subjects . EC was measured via open-circuit spirometry in 12 highly trained male distance runners , and TST K was measured using ultrasonography and dynamometry . Runners were r and omly assigned to either a training or control group . The training group performed 4 × 20 s isometric contractions at 80 % of maximum voluntary plantarflexion moment three times per week for 8 weeks . All subjects ( mean $ $ \dot{V}{\text{O } } _ { 2 } { \max } $ $ = 67.4 ± 4.6 ml kg−1 min−1 ) continued their usual training for running . TST K was measured every 2 weeks . EC was measured in both training and control groups before and after the 8 weeks at three submaximal velocities , corresponding to 75 , 85 and 95 % of the speed at lactate threshold ( sLT ) . Isometric training did neither result in a mean increase in TST K ( 0.9 ± 25.8 % ) nor a mean improvement in RE ( 0.1 ± 3.6 % ) ; however , there was a significant relationship ( r2 = 0.43 , p = 0.02 ) between the change in TST K and change in EC , regardless of the assigned group . It was concluded that TST K and EC are somewhat labile and change together Berryman , N , Maurel , D , and Bosquet , L. Effect of plyometric vs. dynamic weight training on the energy cost of running . J Strength Cond Res 24(7 ) : 1818 - 1825 , 2010-The purpose of this study is to compare the effects of 2 strength training methods on the energy cost of running ( Cr ) . Thirty-five moderately to well-trained male endurance runners were r and omly assigned to either a control group ( C ) or 2 intervention groups . All groups performed the same endurance-training program during an 8-week period . Intervention groups added a weekly strength training session design ed to improve neuromuscular qualities . Sessions were matched for volume and intensity using either plyometric training ( PT ) or purely concentric contractions with added weight ( dynamic weight training [ DWT ] ) . We found an interaction between time and group ( p < 0.05 ) and an effect of time ( p < 0.01 ) for Cr . Plyometric training induced a larger decrease of Cr ( 218 ± 16 to 203 ± 13 ml·kg−1·km−1 ) than DWT ( 207 ± 15 to 199 ± 12 ml·kg−1·km−1 ) , whereas it remained unchanged in C. Pre-post changes in Cr were correlated with initial Cr ( r = −0.57 , p < 0.05 ) . Peak vertical jump height ( VJHpeak ) increased significantly ( p < 0.01 ) for both experimental groups ( DWT = 33.4 ± 6.2 to 34.9 ± 6.1 cm , PT = 33.3 ± 4.0 to 35.3 ± 3.6 cm ) but not for C. All groups showed improvements ( p < 0.05 ) in Perf3000 ( C = 711 ± 107 to 690 ± 109 seconds , DWT = 755 ± 87 to 724 ± 77 seconds , PT = 748 ± 81 to 712 ± 76 seconds ) . Plyometric training were more effective than DWT in improving Cr in moderately to well-trained male endurance runners showing that athletes and coaches should include explosive strength training in their practice s with a particular attention on plyometric exercises . Future research is needed to establish the origin of this adaptation Abstract .Previous research has reported that plyometric training improves running economy ( RE ) and ultimately distance-running performance , although the exact mechanism by which this occurs remains unclear . This study examined whether changes in running performance result ing from plyometric training were related to alterations in lower leg musculotendinous stiffness ( MTS ) . Seventeen male runners were pre- and post-tested for lower leg MTS , maximum isometric force , rate of force development , 5-bound distance test ( 5BT ) , counter movement jump ( CMJ ) height , RE , V˙O2max , lactate threshold ( Thla ) , and 3-km time . Subjects were r and omly split into an experimental ( E ) group which completed 6 weeks of plyometric training in conjunction with their normal running training , and a control ( C ) group which trained as normal . Following the training period , the E group significantly improved 3-km performance ( 2.7 % ) and RE at each of the tested velocities , while no changes in V˙O2max or Thla were recorded . CMJ height , 5BT , and MTS also increased significantly . No significant changes were observed in any measures for the C group . The results clearly demonstrated that a 6-week plyometric programme led to improvements in 3-km running performance . It is postulated that the increase in MTS result ed in improved RE . We speculate that the improved RE led to changes in 3-km running performance , as there were no corresponding alterations in V˙O2max or Thla Purpose The purpose of the current study was to investigate the effects of adding strength training to normal endurance training on running performance and running economy in well-trained female athletes . We hypothesized that the added strength training would improve performance and running economy through altered stiffness of the muscle-tendon complex of leg extensors . Methods Nineteen female endurance athletes [ maximal oxygen consumption ( VO2max ) : 53±3 ml∙kg-1∙min-1 , 5.8 h weekly endurance training ] were r and omly assigned to either normal endurance training ( E , n = 8) or normal endurance training combined with strength training ( E+S , n = 11 ) . The strength training consisted of four leg exercises [ 3 x 4–10 repetition maximum ( RM ) ] , twice a week for 11 weeks . Muscle strength , 40 min all-out running distance , running performance determinants and patellar tendon stiffness were measured before and after the intervention . Results E+S increased 1RM in leg exercises ( 40 ± 15 % ) and maximal jumping height in counter movement jump ( 6 ± 6 % ) and squat jump ( 9 ± 7 % , p < 0.05 ) . This was accompanied by increased muscle fiber cross sectional area of both fiber type I ( 13 ± 7 % ) and fiber type II ( 31 ± 20 % ) in m. vastus lateralis ( p < 0.05 ) , with no change in capillary density in m. vastus lateralis or the stiffness of the patellar tendon . Neither E+S nor E changed running economy , fractional utilization of VO2max or VO2max . There were also no change in running distance during a 40 min all-out running test in neither of the groups . Conclusion Adding heavy strength training to endurance training did not affect 40 min all-out running performance or running economy compared to endurance training only PURPOSE It has been suggested that endurance training influences the running economy ( CR ) and the oxygen uptake ( .VO(2 ) ) kinetics in heavy exercise by accelerating the primary phase and attenuating the .VO(2 ) slow component . However , the effects of heavy weight training ( HWT ) in combination with endurance training remain unclear . The purpose of this study was to examine the influence of a concurrent HWT+endurance training on CR and the .VO(2 ) kinetics in endurance athletes . METHODS Fifteen triathletes were assigned to endurance+strength ( ES ) or endurance-only ( E ) training for 14 wk . The training program was similar , except ES performed two HWT sessions a week . Before and after the training period , the subjects performed 1 ) an incremental field running test for determination of .VO(2max ) and the velocity associated ( V(.VO2max ) ) , the second ventilatory threshold ( VT(2 ) ) ; 2 ) a 3000-m run at constant velocity , calculated to require 25 % of the difference between .VO(2max ) and VT(2 ) , to determine CR and the characteristics of the VO(2 ) kinetics ; 3 ) maximal hopping tests to determine maximal mechanical power and lower-limb stiffness ; 4 ) maximal concentric lower-limb strength measurements . RESULTS After the training period , maximal strength were increased ( P < 0.01 ) in ES but remained unchanged in E. Hopping power decreased in E ( P < 0.05 ) . After training , economy ( P < 0.05 ) and hopping power ( P < 0.001 ) were greater in ES than in E. .VO(2max ) , leg hopping stiffness and the .VO(2 ) kinetics were not significantly affected by training either in ES or E. CONCLUSION Additional HWT led to improved maximal strength and running economy with no significant effects on the .VO(2 ) kinetics pattern in heavy exercise Abstract Ramírez-Campillo , R , Álvarez , C , Henríquez-Olguín , C , Baez , EB , Martínez , C , And rade , DC , and Izquierdo , M. Effects of plyometric training on endurance and explosive strength performance in competitive middle- and long-distance runners . J Strength Cond Res 28(1 ) : 97–104 , 2014—The purpose of this study was to examine the effect of a short-term plyometric training program on explosive strength and endurance performance in highly competitive middle- and long-distance runners . Athletes were r and omly assigned to a control group ( CG , n = 18 , 12 men ) and an explosive strength training group ( TG , n = 18 , 10 men ) . Drop jump ( DJ ) from 20 ( DJ20 ) and 40 cm ( DJ40 ) , countermovement jump with arms ( CMJA ) , 20-m sprint time , and 2.4-km endurance run time test were carried out before and after 6 weeks of explosive strength training . Also , the combined st and ardized performance ( CSP ) in the endurance and explosive strength test was analyzed . After intervention , the CG did not show any significant change in performance , whereas the TG showed a significant reduction in 2.4-km endurance run time ( −3.9 % ) and 20-m sprint time ( −2.3 % ) and an increase in CMJA ( + 8
Output:
| Resistance training led to general improvements in muscular strength , running economy , muscle power factors , and direct performance in distances between 1,500 and 10,000 m. Such improvements were not accompanied by a significant increase in body mass or signs of overtraining .
However , improvements did not occur in all cases , suggesting that they might depend on the specific characteristics of the resistance training applied . |
MS212208 | ***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 purpose of this study was to identify pressure ulcer ( PU ) incidence and risk factors that are associated with PU development in patients in two adult intensive care units ( ICU ) in Saudi Arabia . A prospect i ve cohort study design was used . A total of 84 participants were screened second daily basis until discharge or death , over a consecutive 30-day period , out of which 33 participants with new PUs were identified giving a cumulative hospital-acquired PU incidence of 39·3 % ( 33/84 participants ) . The incidence of medical devices-related PUs was 8·3 % ( 7/84 ) . Age , length of stay in the ICU , history of cardiovascular disease and kidney disease , infrequent repositioning , time of operation , emergency admission , mechanical ventilation and lower Braden Scale scores independently predicted the development of a PU . According to binary logistic regression analyses , age , longer stay in ICU and infrequent repositioning were significant predictors of all stages of PUs , while the length of stay in the ICU and infrequent repositioning were associated with the development of stages II-IV PUs . In conclusion , PU incidence rate was higher than that reported in other international studies . This indicates that urgent attention is required for PU prevention strategies in this setting AIM This study identified risk factors for pressure ulcer development early in the admission stage to determine what appropriate interventions might be conducted early in the admission stage to decrease the risk of pressure ulcer development . BACKGROUND Among patients who develop pressure ulcers , 8 - 40 % of them occur in a critical care setting . Therefore , the development of pressure ulcers is a common problem . DESIGN Prospect i ve cohort study . METHODS The study facility was a 606-bed tertiary care hospital . Ninety eight patients admitted to the intensive care unit ( ICU ) or the high care unit ( HCU ) from 16 April 2003 - 15 July 2003 were evaluated in the final analysis . RESULTS The mean patient age was 62.3 ( SD 16.1 ) years , and the incidence of pressure ulcers in this study was 11.2 % during the observation period . Multivariate analysis showed that ' emergency ICU/HCU patients ' and ' infrequent turning ' were related to pressure ulcer development . Patients with pressure ulcers experienced significantly fewer turns and repositionings ( OR = 0.452 , 95 % CI : 0.212 - 0.966 ] , p < 0.05 . Fewer pressure ulcers developed in scheduled ICU/HCU patients than in emergency ICU/HCU patients ( OR = 0.041 [ 95 % CI : 0.004 - 0.470 ] , p < 0.01 ) . CONCLUSION There was no relationship between pressure ulcer development and APACHE II score , or any medication that affected skin integrity . The frequency of turning and repositioning and patients with an emergency admission to the ICU/HCU can be the prognostic indicators for developing scoring system in critical care setting s. RELEVANCE TO CLINICAL PRACTICE These patients admitted directly to ICU or HCU were in a high risk group , further preventive strategies will be required AIMS To determine the incidence of pressure ulcers occurring at least 48 hours after admission and risk factors for pressure ulcers grade 2 - 4 in a long-stay surgical Intensive Care Unit ( ICU ) population . BACKGROUND The incidence of pressure ulcers in intensive care units is larger than in non-intensive environments . DESIGN Prospect i ve descriptive research design . METHODS Using pressure ulcers grade 2 - 4 as an outcome measure , a multivariate logistic regression analysis was used to identify the risk factors . Data were obtained on a daily basis in a surgical intensive care unit of the University Hospital Leuven between November 2003-March 2004 . A total of 520 long-stay ( > or= 24 hours ) intensive care patients were included . RESULTS Cumulative incidence of pressure ulcers grade 2 - 4 was 20.1 % . The following variables were positively associated with pressure ulcers grade 2 - 4 : history of vascular disease , treatment with Dopamine or Dobutamine , intermittent haemodialysis ( IHD ) or continuous veno-venous haemofiltration ( CVVH ) , mechanical ventilation . Also preventive measures were statistically positively associated with pressure ulcers grade 2 - 4 : turning , floating heels , alternating mattresses , adequate prevention . The use of sedatives , body temperature above 38.5 degrees C and sitting in chair where negatively associated with pressure ulcers . Pressure ulcers are statistically associated with different risk factors and preventive measures . CONCLUSION The identified risk factors are eligible to be included in a new risk assessment scale for patients admitted to intensive care units . RELEVANCE TO CLINICAL PRACTICE The novel insights have implication s for risk assessment for patients in intensive care units . Patients admitted to intensive care units have other risk factors for pressure ulcers which are eligible to be included in a new risk assessment scale The analytical effect of the number of events per variable ( EPV ) in a proportional hazards regression analysis was evaluated using Monte Carlo simulation techniques for data from a r and omized trial containing 673 patients and 252 deaths , in which seven predictor variables had an original significance level of p < 0.10 . The 252 deaths and 7 variables correspond to 36 events per variable analyzed in the full data set . Five hundred simulated analyses were conducted for these seven variables at EPVs of 2 , 5 , 10 , 15 , 20 , and 25 . For each simulation , a r and om exponential survival time was generated for each of the 673 patients , and the simulated results were compared with their original counterparts . As EPV decreased , the regression coefficients became more biased relative to the true value ; the 90 % confidence limits about the simulated values did not have a coverage of 90 % for the original value ; large sample properties did not hold for variance estimates from the proportional hazards model , and the Z statistics used to test the significance of the regression coefficients lost validity under the null hypothesis . Although a single boundary level for avoiding problems is not easy to choose , the value of EPV = 10 seems most prudent . Below this value for EPV , the results of proportional hazards regression analyses should be interpreted with caution because the statistical model may not be valid OBJECTIVE To identify the independent effect of pressure ulcers on excess length of stay and control for all observable factors that may also contribute to excess length of stay . Hospitalized patients who develop a pressure ulcer during their hospital stay are at a greater risk for increased length of stay as compared with patients who do not . DESIGN Cross-sectional , observational study . SETTING Tertiary-care referral and teaching hospital in Australia . PATIENTS Two thous and hospitalized patients 18 years and older who had a minimum stay in the hospital of 1 night and admission to selected clinical units . METHODS Two thous and participants were r and omly selected from 4,500 patients enrolled in a prospect i ve survey conducted between October 2002 and January 2003 . Quantile median robust regression was used to assess risk factors for excess length of hospital stay . RESULTS Having a pressure ulcer result ed in a median excess length of stay of 4.31 days . Twenty other variables were statistically significant at the 5 % level in the final model . CONCLUSIONS Pressure ulcers make a significant independent contribution to excess length of hospitalization beyond what might be expected based on admission diagnosis . However , our estimates were substantially lower than those currently used to make predictions of the economic costs of pressure ulcers ; existing estimates may overstate the true economic cost Stage 1 pressure ulcers are difficult to diagnose . Several prevalence studies have shown that almost half of the pressure ulcers identified are stage 1 . The present study investigated the importance of stage 1 . The following research questions were formulated : Is there a difference between the prevalence of stage 1 pressure ulcers identified in the institutions participating in the present study and that found in the other institutions participating in the Dutch National Prevalence Survey ? What percentage of stage 1 pressure ulcers are reversible within a few hours ? What is the clinical course of stage 1 pressure ulcers ? Which patient characteristics and preventive interventions are related to the clinical course of stage 1 ? The study used a prospect i ve , descriptive and comparative design . All patients of six long-term care hospitals and six acute care hospitals in whom stage 1 pressure ulcers were identified during the 1999 National Prevalence Survey in the Netherl and s were followed for 1 week ( acute care hospitals ; n = 68 patients ) or 2 weeks ( long-term care hospitals ; n = 115 patients ) . The patients were reassessed using the question naire developed for the National Prevalence Survey ( patient characteristics , assessment of risk of pressure ulcers , characteristics of the pressure ulcers and use of preventive methods ) on the same day as the national survey itself , and again after 3 days , after 7 days and after 14 days ( only long-term care hospitals ) . The results showed fewer stage 1 pressure ulcers in the institutions participating in the present study than in the National Prevalence Survey , the difference being almost 50 % . The first re assessment found the prevalence of stage 1 to be further reduced by an average of almost 50 % , a reduction which was greater for the long-term care hospitals than for the acute care hospitals . However , some of the ulcers that had disappeared reappeared in subsequent re assessment s. In the long-term care hospitals , 8.7 % of the stage 1 pressure ulcers deteriorated to a higher stage , vs. 22.1 % in acute care hospitals . No significant patient characteristics were found to affect the course of stage 1 , except that women in acute care hospitals more often had a stage 1 pressure ulcer at the first re assessment than men . In general , patients whose stage 1 ulcer deteriorated were undergoing more preventive interventions ; not all differences were significant . We conclude that , although stage 1 is reversible in most cases , it can be interpreted as an important warning sign for nurses and patients to act . If no adequate interventions are applied , the pressure ulcer may deteriorate BACKGROUND Implementation of the ruling on the Inpatient Prospect i ve Payment System by the Centers for Medicare and Medicaid has challenged nurses to focus on the prevention of pressure ulcers . Despite years of research , pressure ulcers are still one of the most common complications experienced by patients in health care facilities . OBJECTIVE To examine the relationship between patients ' characteristics ( age , sex , body mass index , history of diabetes , and Braden Scale score at admission ) and care characteristics ( total operating room time , multiple surgeries , and vasopressor use ) and the development of pressure ulcers . METHODS In a cohort study , data from the electronic medical records of 3225 surgical patients admitted to a Midwest hospital , from November 2008 to August 2009 were analyzed statistically to determine predictors of pressure ulcers . RESULTS A total of 12 % of patients ( n = 383 ) had at least 1 pressure ulcer develop during their hospitalization . According to logistic regression analysis , scores on the Braden Scale at admission ( P < .001 ) , low body mass index ( P < .001 ) , number of vasopressors ( P = .03 ) , multiple surgeries during the admission ( P < .001 ) , total surgery time ( P < .001 ) , and risk for mortality ( P < .001 ) were significant predictors of pressure ulcers . CONCLUSION Scores on the Braden Scale at admission can be used to identify patients at increased risk for pressure ulcers . For other high-risk factors , such as low body mass index and long operative procedures , appropriate clinical interventions to manage these conditions can help prevent pressure ulcers PURPOSE : We sought to describe the occurrence of pressure ulcers in patients managed in a surgical intensive care unit ( ICU ) and report preliminary work toward development of a pressure ulcer risk assessment tool for use in this population that incorporates comorbidities and other factors not addressed in previous instruments . SUBJECTS AND SETTING S : Three hundred sixty-nine patients managed in the surgical ICU at Yale-New Haven Hospital comprised the sample . METHODS : Demographic and clinical data , including Braden Scale scores , were collected in this prospect i ve , 2-phase study . The principal investigator ( G.C.S. ) performed skin assessment s on all patients . We used chi-square analysis and t tests to determine variables to include in a stepwise logistic regression analysis to determine factors independently associated with the development of pressure ulcers . INSTRUMENT : We collected data , using a form we developed that contained demographic and clinical factors found in previous research and in our clinical practice to be associated with pressure ulcers . RESULTS : Eighty-eight out of 369 patients ( 23.9 % ) experienced a hospital-acquired pressure ulcer . Braden Scale scores ranged from 6 to 21 , with a mean score of 11.9 ± 2.2 . A lower Braden Scale score , the presence of diabetes mellitus , and patient age 70 years or older independently predicted the development of a pressure ulcer . These factors have been incorporated into the preliminary Surgical ICU Pressure Ulcer Risk Assessment scale . CONCLUSIONS : Findings from this study suggest that , in addition to a low Braden Scale score , age > 70 years and a diagnosis of diabetes may represent clinical ly relevant pressure ulcer risk factors in the surgical intensive care population and that patients with these factors may benefit from more aggressive preventive care . In addition , the Surgical ICU Pressure Ulcer Risk Assessment scale requires additional psychometric testing before its use can be recommended for the research or practice setting AIMS AND OBJECTIVES The study aim ed to evaluate the predictive validity and accuracy of a new pressure ulcer risk assessment scale in two Indonesia intensive care units ( ICUs ) . BACKGROUND Several risk assessment scales have been design ed to identify patients at risk of developing pressure ulcers in ICU . However , the relative weight of each variable that contributes to pressure ulcer development in these scales is not described to enable design ing of a risk
Output:
| Maximal pressure injury prevention efforts are particularly important among critical-care patients who are older , have altered mobility , experience poor perfusion , or who are receiving a vasopressor infusion |
MS212209 | ***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 Our aim was to prospect ively assess in-vivo color alterations of natural teeth associated with fixed orthodontic treatment . METHODS Twenty-six consecutive patients were treated with fixed appliances bonded with a chemically cured or a light-cured resin with a split-mouth design . The spectrophotometric data of a st and ardized labial circular area of all teeth were recorded , before bracket bonding and after debonding and cleaning procedures . The color parameters of the Commission Internationale de l'Eclairage-L∗ , a∗ , and b∗ ( lightness , red/green , and blue/yellow)-were measured for each adhesive and type of tooth , and the corresponding color differences ( ΔE ) between the interval groups were calculated . The effect of these parameters on color was assessed with 3-way mixed analysis of variance ( ANOVA ) and the Bonferroni comparisons test ( α < 0.05 ) . RESULTS Orthodontic treatment was associated with changes in color parameters . The L∗ values decreased ( P < 0.001 ) , whereas the a∗ and b∗ values increased ( P < 0.001 ) at the end of treatment . All measured types of teeth demonstrated significant color changes ( ΔE ) ; their mean differences ranged from 2.12 to 3.61 ΔE units . Chemically cured resin was associated with greater color changes than light-cured composite . CONCLUSIONS The color of natural teeth is changed in various ways after fixed orthodontic treatment The purpose of this study was to examine the effects of ultrasonic orthodontic bracket removal and cleanup and compare them with conventional debonding and cleaning of the enamel surfaces with burs and polishing disks . The amount of enamel loss and time for bracket removal and clean-up were also addressed . Thirty extracted human premolars were collected . The teeth were r and omly placed in one of the three debonding groups : debonding with orthodontic pliers and enamel clean-up with finishing burs and polishing disks ( group 1 ) , debonding with orthodontic pliers and ultrasonic clean-up of the enamel surface ( group 2 ) , and ultrasonic debonding enamel clean-up ( group 3 ) . The teeth were stored for 48 hours in 100 % humidity before bracket removal . All brackets were then removed . Polyvinyl siloxane impressions were made before and after bracket removal . Direct measurements of the teeth in micrometers were made at all steps . An additional 30 teeth were similarly prepared , and the brackets were debonded and cleaned-up as in the three groups previously described . The total time for bracket removal and enamel clean-up for each group was recorded in seconds . ( ABSTRACT TRUNCATED AT 250 WORDS The purpose of this study was to evaluate enamel colour alteration of five different orthodontic bonding adhesives by means of digital measurements after exposure to photoageing in order to simulate discolouration of adhesives in vivo . Seventy-five non-carious premolars were r and omly divided into five equal groups . The brackets were bonded with five different adhesives ( Transbond XT , Eagle Bond , Light Bond , Blugloo , Unite ) and subjected to artificial accelerated photoageing for 24 hours . The enamel surfaces were colourimetrically evaluated before bonding , following debonding and cleaning with a tungsten carbide bur , after polishing with Stainbuster , and after photoageing of the debonded enamel surface . The Commission Internationale de l'Eclairage(CIE ) colour parameters ( L*a*b * ) were recorded and colour differences ( DeltaE ) were calculated . The results were statistically analyzed using the Kruskall-Wallis test . Further investigation among subgroups was performed using Dunn 's multiple correlation test ( P < 0.05 ) . The clinical detection threshold for DeltaE value was set at 3.7 units . DeltaE values between the first and second measurements showed an increase in the Transbond XT , Eagle Bond , and Light Bond groups . The highest DeltaE value was 1.51 + /- 1.15 in the Transbond XT group . No clinical ly significant DeltaE value was observed . Colour changes of orthodontic bonding systems induced by photoageing can not be clinical ly observed . Polishing with Stainbuster eliminates enamel surface roughness , which may improve light reflection
Output:
| The studies review ed suggested that orthodontic treatment alters the original color of enamel , and both adhesive systems and resin-removal methods can contribute to this change .
Conclusion There is no strong evidence from this review that orthodontic treatment with fixed appliances alters the original color of enamel . |
MS212210 | ***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 : Gastroesophageal reflux disease can be divided into three categories : nonerosive GERD ( NERD ) , erosive GERD ( ERD ) , and Barrett´s esophagus . A shift among these categories rarely occurs . The aim of the present study was to eluci date potential patient-associated risk factors associated with ERD . METHODS : A total of 6,215 patients with troublesome heartburn were recruited to a large , prospect i ve , multicenter open cohort study comprising an initial treatment phase and a 5-yr follow-up phase . Each center planned to recruit an equal number of patients with NERD and ERD . All patients underwent an interview based on st and ardized question naires , a physical examination , and endoscopy with biopsies . Data were analyzed by multiple logistic regression analysis . RESULTS : Risk factor analysis was performed on 5,289 patients ( NERD : n = 2,834 ; ERD : n = 2,455 ) , which was the intent-to-treat population excluding patients with suspected/proven complicated reflux disease . Stepwise regression analysis identified the following independent predictors of ERD : male gender , overweight , regular use of alcohol , a history of GERD > 1 yr , and smoker or ex-smoker . A higher level of education and a positive Helicobacter pylori ( H. pylori ) status were associated with a lower risk of ERD . CONCLUSIONS : Some patient-associated factors increase the risk of erosive esophagitis as opposed to nonerosive reflux disease . However , no single factor or combination of factors is capable of predicting mucosal damage with clinical ly sufficient certainty . Thus , endoscopy is still required in all GERD patients if valid information on the state of the esophageal mucosa is needed BACKGROUND Limited research has been done to explore differences between ethnic groups , including Hispanic Americans ( HAs ) , in the association between percentage body fat ( PBF ) and body mass index ( BMI ; in kg/m(2 ) ) ; the numbers of HAs are increasing in the US population . OBJECTIVE We investigated whether the relation between PBF and BMI in adult HAs differed from that of African Americans ( AAs ) and European Americans ( EAs ) . DESIGN We used a multiple regression model in which PBF measured with dual energy X-ray absorptiometry was predicted by the reciprocal of BMI ( 1/ BMI ; in m(2)/kg ) in a sample of 487 men ( n(EA ) = 192 , n(AA ) = 148 , and n(HA ) = 147 ) and 933 women ( n(EA ) = 448 , n(AA ) = 304 , and n(HA ) = 181 ) . RESULTS For men , our results showed no significant differences between HAs and EAs , AAs and EAs , or HAs and AAs in the slope of the line relating 1/ BMI to PBF . In women , there were significant differences in PBF as predicted by BMI between HAs and EAs ( P < 0.002 ) and AAs and HAs ( P = 0.020 ) , but not between AAs and EAs . When PBF was estimated on the basis of predicting equations , the trend of the predicted PBF value in women differed according to ethnic group and BMI category . At a BMI < 30 , HAs tended to have more body fat than did EAs and AAs , and at a BMI > 35 , EAs tended to have more body fat than did the other groups . CONCLUSIONS Our results show that the relation between PBF and BMI in HA women differs from that of EA and AA women AIM Gastroesophageal reflux disease ( GERD ) is a common disorder in the Western population , but detailed population -based data in China are limited . The aim of this study was to underst and the epidemiology of symptomatic gastroesophageal reflux ( SGER ) in adults of Xi'an , a northwestern city of China , and to explore the potential risk factors of GERD . METHODS Symptoms suggestive of GERD , functional dyspepsia ( FD ) , irritable bowel syndrome ( IBS ) , upper respiratory diseases and some potential risk factors were investigated in a face-to-face manner in a region-stratified r and om sample s of 2789 residents aged 18 - 70 years in Xi'an by using a st and ardized question naire . METHODS With a response rate of 91.8 % , the prevalence of SGER was 16.98 % ( 95 % CI , 14.2 - 18.92 ) in Xi'an adults , and no gender-related difference was observed ( P<0.05 ) . SGER was more common among subjects aged 30 - 70 years than in those aged 18 - 29 years ( P<0.01 ) . The prevalence of SGER in rural , urban and suburban subjects was 21.07 % , 17.44 % and 12.12 % , respectively , and there was a significant difference between rural , urban and suburban regions ( P<0.05 ) . Compared with subjects without SGER , the prevalence of symptoms suggestive of FD and IBS , pneumonia , asthma , bronchitis , laryngitis , pharyngitis , chronic cough , wheeze , globus sensation , oral ulcer and snore was significantly increased in subjects with SGER ( P<0.01 ) . Heavy smoking ( OR=5.76 ; CI , 3.70 - 6.67 ) , heavy alcohol use ( OR=2.85 ; CI , 1.67 - 4.49 ) , peptic ulcer ( OR=5.76 ; CI , 3.99 - 8.32 ) , cerebral palsy ( OR=3.97 ; CI , 1.97 - 8.00 ) , abdominal operation ( OR=2.69 ; CI , 1.75 - 4.13 ) , obesity ( OR=2.16 ; CI , 1.47 - 3.16 ) , excessive food intake ( OR=1.43 ; CI , 1.17 - 1.15 ) , sweet food ( OR=1.23 ; CI , 0.89 - 1.54 ) , and consumption of coffee ( OR=1.23 ; CI , 0.17 - 2.00 ) were independently associated with SGER . The episodes of GERD were commonly precipitated by dietary factors ( 66.05 % ) , followed by body posture ( 26.54 % ) , ill temper ( 23.72 % ) , fatigue ( 22.32 % ) and stress ( 10.93 % ) . CONCLUSION GERD is common in Xi'an 's adult population with a mild or moderate degree . The etiology and pathogenesis of GERD are probably associated with FD , IBS , and some respiratory , laryngopharyngeal and odontostological diseases or symptoms . Some lifestyles , diseases and dietary factors are the risk factors of GERD BACKGROUND This paper reports the 3-month prevalence rates of gastrointestinal ( GI ) symptoms from the Domestic/International Gastroenterology Surveillance Study ( DIGEST ) , and their relationship with demographic factors ; namely age , gender and body mass index ( BMI ) . METHODS Subjects were recruited from 10 international sites by a total of 5581 face-to-face interviews conducted with r and omly selected members of the general population aged 18 years and over ( 50.6 % female ; mean age 44 years ) . The sample was divided according to whether subjects reported 1 or more of 14 GI symptoms , or no GI symptoms . Those with any of 11 upper GI symptoms were then subdivided according to their most bothersome symptom : gastro-oesophageal reflux (GORD)-like symptoms , ulcer-like symptoms or dysmotility-like symptoms . Symptoms were classified as relevant if they were of at least moderate severity and /or occurred at least once a week . RESULTS A mean of 46.4 % of subjects reported experiencing one or more of the 14 GI symptoms , with 28.1 % experiencing upper GI symptoms classified as relevant . Significant differences between the prevalences of relevant symptoms were evident between sampling sites . The estimated prevalence of GORD-like symptoms for the pooled sample was 7.7 % . For ulcer-like symptoms , prevalence was 4.1 % , and for dysmotility-like symptoms 15.5 % . Significant differences were observed in the prevalence rates of symptom groups between countries . Women were significantly more likely than men to experience relevant symptoms , with gender differences also observed in the rates of GORD-like and dysmotility-like symptoms . The proportion of those with relevant symptoms experiencing GORD-like symptoms increased significantly with age ; ulcer-like symptoms showed no significant relationship with age ; and dysmotility-like symptoms decreased significantly with age . The prevalence of relevant symptoms increased with increasing BMI . CONCLUSIONS In conclusion , the DIGEST has provided valuable data on the cross-country prevalence of upper GI symptoms , and their association with biological factors Abstract A r and omized chemoprevention trial on precancerous lesions of the stomach is being conducted in Tachira State , Venezuela . The aims of the study are to evaluate the efficacy of vitamin supplementation in preventing the progression rate of precancerous lesions . Here we report on the pilot phase of the study in which two antioxidant preparations were evaluated on their ability to raise antioxidant levels in plasma and in gastric juice . The study aim ed also to determine the antibiotic sensitivity profiles of Helicobacter pylori isolates prevalent in the area . Forty-three subjects with precancerous lesions ( chronic gastritis , chronic atrophic gastritis , intestinal metaplasia and dysplasia ) of the stomach were r and omized to one of two antioxidant treatments . Treatment 1 ( 250 mg of st and ard vitamin C , 200 mg of vitamin E and 6 mg of beta-carotene three times a day ) or treatment 2 ( 150 mg of st and ard vitamin C , 500 mg of slow release vitamin C , 75 mg of vitamin E and 15 mg of beta-carotene once a day ) for 7 days . Blood levels of total vitamin C , beta-carotene and alpha-tocopherol and gastric juice levels of ascorbic acid and total vitamin C were measured before and after treatment on day 8 . Both treatments increased the plasma levels of total vitamin C , beta-carotene and alpha-tocopherol/cholesterol but not those of ascorbic acid or total vitamin C in gastric juice . Treatment 1 was the best choice and result ed in a greater increase in the plasma levels of beta-carotene and alpha-tocopherol . H. pylori was cultured from 90 % of the gastric biopsies ; 35 isolates were identified which were highly resistant to metronidazole , a front-line antibiotic recommended against H. pylori in other setting A question naire study was conducted to assess the prevalence and severity of symptoms suggestive of esophageal disorders in a general population . The study included 407 r and omly selected subjects , evenly distributed in terms of sex and age , within the age span of 20 - 79 years . A total of 337 subjects replied ( 85 % ) . Symptoms suggestive of gastroesophageal reflux were found among 25 % of the participants . Cough on swallowing was common ( 27 % ) , as was globus ( 16 % ) and chest pain ( 13 % ) . In addition , dysphagia was reported by 10 % and vomiting by 9 % . The symptoms were usually mild , and moderate to severe symptoms were reported only occasionally ( 1 - 4 % ) . No statistical correlation was found between esophageal symptoms and age , sex , or the reported consumption of tobacco , alcohol , or non-steroidal anti-inflammatory drugs . The frequency of heartburn and /or acid regurgitation was twice as common among those with symptoms of respiratory disease as among those with no respiratory complaints . A stepwise logistic regression analysis showed that a chronic cough and /or breathing difficulties were significantly related to the presence of symptoms suggestive of gastroesophageal reflux We have studied the response of erosive or ulcerative esophagitis to treatment with omeprazole and its subsequent relapse on cessation of therapy in 196 patients . In the first phase of the study omeprazole ( 20 or 40 mg daily ) was compared with placebo in 64 patients . After 4 wk there was endoscopic healing in 81 % ( 25 of 31 ) of omeprazole-treated patients and in only 6 % ( 2 of 32 ) of placebo-treated patients . Endoscopic healing of esophagitis was accompanied by symptom relief and histologic healing of ulceration . In the second ( dose finding ) phase a further 132 patients were r and omized to omeprazole ( 20 or 40 mg daily ) and endoscopic healing was assessed . In patients with the mildest grade of ulcerative esophagitis ( grade 2 ) , healing occurred at 4 wk in 87 % receiving 20 mg and in 97 % receiving 40 mg . In patients with grade 3 esophagitis , 67 % ( 20 mg ) and 88 % ( 40 mg ) were healed . Less than half the patients with grade 4 esophagitis ( Barrett 's ulcers or
Output:
| : This analysis demonstrates a positive association between increasing BMI and the presence of GERD within the United States ; this relationship became apparent only after stratification by country and level of BMI . |
MS212211 | ***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 Human papillomavirus ( HPV ) has been associated with cervical intraepithelial neoplasia , but the temporal relation between the infection and the neoplasia remains unclear , as does the relative importance of the specific type of HPV , other sexually transmitted diseases , and other risk factors . METHODS We studied prospect ively a cohort of 241 women who presented for evaluation of sexually transmitted disease and had negative cervical cytologic tests . The women were followed every four months with cytologic and colposcopic examinations of the uterine cervix and tests for HPV DNA and other sexually transmitted diseases . RESULTS Cervical intraepithelial neoplasia grade 2 or 3 was confirmed by biopsy in 28 women . On the basis of survival analysis , the cumulative incidence of cervical intraepithelial neoplasia at two years was 28 percent among women with a positive test for HPV and 3 percent among those without detectable HPV DNA : The risk was highest among those with HPV type 16 or 18 infection ( adjusted relative risk as compared with that in women without HPV infection , 11 ; 95 percent confidence interval , 4.6 to 26 ; attributable risk , 52 percent ) . All 24 cases of cervical intraepithelial neoplasia grade 2 or 3 among HPV-positive women were detected within 24 months after the first positive test for HPV . After adjustment for the presence of HPV infection , the development of cervical intraepithelial neoplasia was also associated with younger age at first intercourse , the presence of serum antibodies to Chlamydia trachomatis , the presence of serum antibodies to cytomegalovirus , and cervical infection with Neisseria gonorrhoeae . CONCLUSIONS Cervical intraepithelial neoplasia is a common and apparently early manifestation of cervical infection by HPV , particularly types 16 and 18 Am J Public Health 2000 90:1431–5 A cross-sectional , door-to-door community survey was used to gather self-report data on Pap smear and cholesterol screening from 195 rural Australian individuals r and omly selected from population statistics . Trained interviewers used a st and ard reporting form to collect information on screening results , knowledge of recommended screening frequency , and demographics . The two regional pathology laboratories were queried about consenting patients . Adequate screening was defined as any smear within 2 years . Of 146 women eligible for validation of Pap smears , the sensitivity of a self-report of inadequate screening was 45 % , the specificity was 98 % , the negative predictive value was 72 % , and the positive predictive value was 93 % . For example , 93 % of women who said they had not had a Pap smear in at least 2 years in fact had not , while only 72 % of those who cl aim ed to have had a smear within 2 years actually had . Among 91 women reporting Pap results , more than half of those with abnormalities were missed by self-report . The accuracy of recall was not associated with knowledge or demographic factors . Comment : Although its use of a rural , Australian population limits the ability to generalize the conclusions of the report for the population in the United States , the results of this study are consistent with those of previous ones : women tend to overestimate the frequency of their Pap smears and to minimize their recall of abnormalities . Self-report should not be used in studies of the adequacy of Pap smear screening , and it should not be relied on to determine who is eligible for screening at 3-year intervals by virtue of three prior normal smears . ( LSM Objective : To estimate the incidence and duration of cervical human papillomavirus (HPV)-6 , HPV-11 , HPV-16 , and HPV-18 infections in a population of young American women . Methods : The study population consisted of U.S. women who at baseline were 16 to 23 years of age , reported zero to five lifetime sexual partners , never having been pregnant , and never having had a prior abnormal Papanicolaou test and were enrolled in the placebo arm of a r and omized multicenter clinical trial of a HPV-16 L1 virus-like particle vaccine . Women underwent type-specific endocervical/ectocervical swab HPV DNA testing at ∼6-month intervals for up to 48 months of follow-up . To contribute person-time in the analyses of type-specific HPV incidence , a woman must have had at least three satisfactory swab specimens available and been negative for the relevant HPV type ( HPV-6 , HPV-11 , HPV-16 , or HPV-18 ) on her first two trial swabs . The duration of incident HPV infections was estimated using Kaplan-Meier survival analysis methods . Results : Person-years of exposure ranged by type-specific analysis from 2,645 to 3,188 , with an incidence rate per 100 person-years of 3.6 for HPV-6 , 0.4 for HPV-11 , 5.4 for HPV-16 , and 2.1 for HPV-18 . With censoring at the time of treatment for cervical intraepithelial neoplasia , where done , the mean duration of incident infections was 9.3 , 8.4 , 18.2 , and 16.4 months , respectively , for HPV-6 ( n = 103 ) , HPV-11 ( n = 13 ) , HPV-16 ( n = 142 ) , and HPV-18 ( n = 62 ) . When the duration of HPV infections was truncated at the time of cervical intraepithelial neoplasia detection ( any grade ) , where applicable , mean duration figures were 8.4 , 8.1 , 14.0 , and 15.1 months for HPV-6 , HPV-11 , HPV-16 , and HPV-18 infections , respectively . Conclusions : Previous studies of the mean duration of cervical HPV infection have been based on prevalent infections and /or featured relatively short duration of follow-up . This study tested women for HPV infection over a period of up to 48 months and observed a mean duration of incident HPV-16/HPV-18 infections approximately twice that of HPV-6/HPV-11 . ( Cancer Epidemiol Biomarkers Prev 2007;16(4):709–15 Human papillomavirus ( HPV ) infection causes cervical cancer and genital warts . Young women ( 1106 ) were r and omized to receive one of three formulations of a quadrivalent HPV ( Types 6/11/16/18 ) L1 virus-like particle ( VLP ) vaccine or one of two placebo formulations . The goal was to assess vaccine safety and immunogenicity in baseline HPV 6/11/16 or 18-naïve and previously infected subjects . All three formulations were highly immunogenic . At Month 2 ( postdose 1 ) , among women with vaccine-type antibodies at baseline , vaccine-induced anti-HPV responses were approximately 12- to 26-fold higher than those observed in baseline-naïve women , suggesting an anamnestic response . Following an initial , similar sized decline , anti-HPV responses plateaued and remained stable through end-of- study ( 3.0 years ) . No vaccine-related serious adverse experiences were reported OBJECTIVE : Human papillomavirus ( HPV ) virus-like particle ( VLP ) vaccines have demonstrated effectiveness in preventing persistent HPV infections . Whether protection lasts longer than 18 months and , thus , impacts rates of cervical intraepithelial neoplasia ( CIN ) 2–3 has not yet been established . We present results from an HPV16 L1 VLP vaccine trial through 48 months . METHODS : A total of 2,391 women , aged 16–23 years , participated in a r and omized , double-blind , placebo-controlled trial . Either 40 & mgr;g HPV16 L1 VLP vaccine or placebo was given intramuscularly at day 1 , month 2 , and month 6 . Genital sample s for HPV16 DNA and Pap tests were obtained at day 1 , month 7 , and then 6-monthly through month 48 . Colposcopy and cervical biopsies were performed if clinical ly indicated and at study exit . Serum HPV16 antibody titer was measured by radioimmunoassay . RESULTS : Among 750 placebo recipients in the per protocol population , 12 women developed HPV16-related CIN2–3 ( 6 CIN2 and 6 CIN3 ) . Among 755 vaccine recipients , there were no cases ( vaccine efficacy 100 % , 95 % confidence interval [ CI ] 65–100 % ) . There were 111 cases of persistent HPV16 infection in placebo recipients and 7 cases in vaccine recipients ( vaccine efficacy 94 % , 95 % CI 88–98 % ) . After immunization , HPV16 serum antibody geometric mean titers peaked at month 7 ( 1,519 milli-Merck units [mMU]/mL ) , declined through month 18 ( 202 mMU/mL ) , and remained relatively stable between month 30 and month 48 ( 128–150 mMU/mL ) . CONCLUSION : The vaccine HPV16 L1 VLP provides high-level protection against persistent HPV16 infection and HPV16-related CIN2–3 for at least 3.5 years after immunization . Administration of L1 VLP vaccines targeting HPV16 is likely to reduce risk for cervical cancer . LEVEL OF EVIDENCE : CONTEXT Every year approximately 2 million US women are diagnosed as having a cervical cytological result of atypical squamous cells of undetermined significance ( ASC-US ) . OBJECTIVE To determine the most efficient and cost-effective management strategy for women in the United States diagnosed as having ASC-US . DESIGN AND SETTING Cost-effectiveness analysis of data from clinical trials , prospect i ve studies , and other published literature . A computer-based model was used to compare 4 management strategies for a cytological result of ASC-US : immediate colposcopy ; human papillomavirus ( HPV ) triage , which includes colposcopy if high-risk HPV types are detected ; repeat cytology , which includes follow-up cytology at 6 and 12 months and referral for colposcopy if a repeat abnormal result occurs ; and reclassifying ASC-US as normal in which a cytological result of ASC-US is ignored . Reflex HPV DNA testing uses either residual liquid-based cytological specimens or sample s co-collected at the time of the initial screening for conventional cytology . Another method , referred to as the 2-visit HPV DNA triage , requires a woman with an ASC-US result to return within 1 month to provide another speciman sample . MAIN OUTCOME MEASURES Years of life saved ( YLS ) , quality -adjusted life-years ( QALYs ) , and incremental cost-effectiveness ratios . RESULTS The least costly strategy for biennial screening was to reclassify ASC-US as normal , result ing in a reduction in total cancer incidence of 75 % for conventional cytology and 84 % for liquid-based cytology compared with no screening . The next least costly strategy was HPV DNA testing result ing in a reduction in total cancer incidence of 86 % for conventional cytology and 90 % for liquid-based cytology , followed by immediate colposcopy with a reduction of 87 % and 91 % , respectively . Compared with reflex HPV DNA testing , a strategy of repeat cervical cytology or delayed HPV testing costs more but is less effective . When all strategies were compared simultaneously , varying frequency and type of cytological test , biennial ( vs every 3 years ) liquid-based cytology with reflex HPV testing had a cost of $ 174 200 per YLS . In a similar comparison , liquid-based cytology with reflex HPV testing conducted every 3 years ( vs every 5 years ) had a cost of $ 59 600 per YLS and was more effective and less costly than a strategy of conventional cytology incorporating repeat cytology or immediate colposcopy conducted biennially . CONCLUSION Reflex HPV DNA testing provides the same or greater life expectancy benefits and is more cost-effective than other management strategies for women diagnosed as having ASC-US In a study involving 13 842 women and 113 gynaecologists , liquid-based cytology and HPV testing for detecting cervical cancer were compared . A total of 1334 women were found to be positive for one or both tests and were invited for colposcopy with biopsy . A total of 1031 satisfactory biopsies on 1031 women were thereafter collected using a systematic biopsy protocol , which was r and om in the colposcopically normal-appearing cervix or directed in the abnormal one . In all , 502 women with negative tests were also biopsied . A total of 82 histologic high- grade squamous intraepithelial lesion ( HSIL ) were reported in biopsies , all from the group with one or both tests positive . Sensitivity and specificity to detect histologic HSIL were 59 and 97 % for cytology , and 97 and 92 % for
Output:
| Results Published data meeting review eligibility criteria were most plentiful for natural history parameters relating to the progression and regression of cervical intraepithelial neoplasia ( CIN ) without HPV typing , and data concerning the natural history of HPV disease due to specific HPV types were often lacking .
Epidemiologic evidence to support age-dependency in the risk of progression and regression of HPV disease was found to be weak , and an alternative hypothesis concerning the time-dependence of transition rates is explored .
No data were found on the duration of immunity following HPV infection .
In the area of clinical management , data were observed to be lacking on the proportion of clinical ly manifest anogenital warts that are treated and the proportion of cervical cancer cases that become symptomatic by stage . |
MS212212 | ***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 Alteplase is approved for use in the restoration of function to occluded central venous access devices ( CVADs ) ; however , there are few prospect i ve studies in children . This study was undertaken to evaluate the safety and efficacy of alteplase in the treatment of CVAD occlusions in a pediatric population . MATERIAL S AND METHODS A prospect i ve , multicenter , open-label , single-arm study evaluating a maximum of two doses ( < or = 2 mg per dose ) of alteplase was performed in pediatric patients . Inclusion criteria included patient age less than 17 years with an occluded CVAD ( single- , double- , and triple-lumen catheter or implanted port ) . Patients with hemodialysis catheters , those with known mechanical occlusion , or those considered at high risk for bleeding or embolization were excluded . Assessment of function was made 30 and 120 minutes ( if required ) after each dose . The primary objective of the study was to evaluate the safety of alteplase as measured by the incidence of intracranial hemorrhage ( ICH ) ; secondary objectives included the evaluation of specific targeted serious adverse events and efficacy of alteplase in the restoration of catheter function . RESULTS A total of 310 patients ( 174 male patients , 136 female patients ; mean age , 7.2 years ; range , 0.04 - 18.3 y ) were treated ; 55 of the patients ( 17.7 % ) were younger than 2 years of age . No patients experienced ICH ( 95 % CI , 0%-1.2 % ) . Nine serious adverse events were noted in eight patients ( 2.6 % incidence ) , two of which were attributed by the investigator to study drug administration ( one case of sepsis and one case of a ruptured catheter lumen ) . The cumulative rate of restoration of CVAD function after serial administration of a maximum of two instillations of alteplase , each with a maximum dwell time of 120 minutes , was 82.9 % ( 95 % CI , 78.2%-86.9 % ) . Similar rates of catheter function restoration were seen among all catheter types studied ; there were no clinical ly meaningful differences among age or sex subgroups . CONCLUSION The administration of alteplase is safe and effective for the restoration of function to CVADs in pediatric patients BACKGROUND Sodium citrate has antibacterial and anticoagulant properties that are confined to the catheter when used as a catheter lock . Studies of its use as a catheter lock have suggested its efficacy in preventing infection and bleeding complications compared with sodium heparin . STUDY DESIGN Open-label r and omized controlled trial of 2 catheter locks to examine the hypothesis that sodium citrate catheter locks will reduce catheter-related bacteremia and exit-site infection . SETTING S & PARTICIPANTS 232 consenting long-term hemodialysis patients in 4 satellite dialysis units to a large dialysis program with protocol ized treatment and targets . All patients were using twin-catheter single-lumen Tesio-Caths ( MedComp , Harleysville , PA ) . INTERVENTION 6 months ' use of 46.7 % sodium citrate ( citrate ) or 5 % heparin ( heparin ) locked postdialysis in the dead space of the central venous catheter . OUTCOMES & MEASUREMENTS Primary end point of catheter-related bacteremia and exit-site infection . Secondary end points of catheter thrombosis defined by the use of urokinase lock and infusion , new catheter insertion , catheter-related admission , blood transfusions , parenteral iron , and erythropoietin requirements . RESULTS Catheter-related bacteremia did not differ in the 2 groups , with an incidence of 0.7 events/1,000 catheter-days . There was no significant difference in rates of exit-site infection ( 0.7 versus 0.5 events/1,000 catheter-days ; P = 0.5 ) . The secondary end point of catheter thrombosis defined by the use of a urokinase lock was significantly more common in the citrate group , with an incidence of 8 versus 4.3/1,000 catheter-days ( P < 0.001 ) . Other secondary end points did not differ . Citrate treatment was curtailed compared with heparin because of a greater incidence of adverse events , with a mean treatment duration before withdrawal of 4.8 + /- 2.0 versus 5.7 + /- 1.2 months , respectively ( P < 0.001 ) . LIMITATIONS Low baseline catheter-related bacteremia and exit-site infection event rates may have underpowered this study . High adverse-event rates may have been related to high-concentration citrate that led to increased overspill and reduction in lock volume . This may also explain the increased rates of thrombosis in this group . CONCLUSION Widespread and long-term use of 46.7 % citrate catheter locks with Tesio-Cath access is not justified by this study The most effective and safe method of maintaining peripheral intravenous lock in children is an important clinical question that has been identified by the research ers . The results of recent studies comparing saline versus 10 units/ml of heparin saline flush using a 24-gauge catheter in neonatal and pediatric population s are conflicting and inconclusive . The objectives of this study were to evaluate the effectiveness and safety of three flush solutions : normal saline , 1 unit/ml of heparin saline and 10 units/ml of heparin saline for maintaining peripheral intravenous locks in children , and to establish a research -based practice in the study hospital . In a prospect i ve , r and omized controlled , double-blind trial , one hundred and twenty-three subjects ranging in age from 1 - 10 years with 123 intravenous locks were r and omly chosen to receive 1 unit/ml of heparin saline , 10 units/ml of heparin saline and normal saline to evaluate length of catheter use , survival rate and incidence of intravenous complications . The study found no statistically significant differences in length of catheter use , estimated catheter survival and the incidence of intravenous complications among the three groups . The group that received 1 unit/ml of heparin saline demonstrated the highest rate of survival . The mean length of catheter use of the group that received 1 unit/ml of heparin saline ( 49.8 hours ) was 17 hours longer than the group that received normal saline ( 32.5 hours ) . There are no significant differences among the three types of flushing solution in terms of the catheter longevity and incidence of intravenous complications From January 1986 to December 1990 we studied angiographically the subclavian-brachiocephalic vein of 100 patients dialysed by subclavian catheter for 50 ( first group ) and by internal jugular catheter for the 50 others ( second group ) . These two groups were not statistically different as regards age ( 61.6 + /- 11.3 years in the first and 61 + /- 11.1 in the second ) , sex ( 48 % and 56 % were women ) , duration of catheter insertion ( 31 + /- 21.8 and 31.7 + /- 16 days ) , and the number of dialysis sessions ( 13.5 + /- 9.1 and 13.6 + /- 7.1 ) . The type of catheters , the frequency of removal for poor flow ( 16 % in both groups ) or infections ( 6 % in both groups ) , and the local nursing were similar in the two groups . The only difference was the side of cannulation : the right side in 58 % of cases in group 1 and 78 % in group 2 . The angiographic study revealed a stenosis of the vein in 42 % of the subclavian group and in 10 % of the internal jugular group : a dramatic difference in favour of the internal jugular route , whose superiority over the subclavian route is asserted in respect of venous access of dialysed patients Soft , cuffed , implantable central venous catheters such as the Quinton Permcath ( Quinton Instrument Co , Seattle , WA ) are increasingly used as permanent access in patients with end-stage renal disease . Their major limitations , besides infection , are thrombosis and inadequate blood flow . To prevent those complications , heparin is conventionally used for priming the Quinton Permcath between dialysis sessions . In this study , we compared recombinant tissue plasminogen activator ( rTPA ) with heparin for priming the Quinton Permcath in a prospect i ve , r and omized , crossover design . Twelve patients were r and omly assigned to receive 2,000 IU of heparin or 2 mg of rTPA injected into each catheter lumen at the end of each dialysis session over a period of 4 months , followed by a switch to the other substance . Blood flow rate ( flow ) , venous pressure ( VP ) , and arterial pressure ( AP ) were monitored at each dialysis session hourly . Flow was significantly greater ( P = 0.0001 ) with rTPA ( mean + /- SD , 237.7 + /- 18.1 and 231.6 + /- 12.4 mL/min for the first and second 2 months , respectively ) compared with heparin ( 208.5 + /- 10.1 and 206.9 + /- 14.2 mL/min for the first and second 2 months , respectively ) . VP was significantly less ( P = 0.0001 ) with rTPA ( 135.4 + /- 8.2 and 140 + /- 15.2 mm Hg for the first and second 2 months , respectively ) compared with heparin ( 160.5 + /- 16.1 and 159.2 + /- 20.7 mm Hg for the first and second 2 months , respectively ) . AP was significantly greater ( P = 0.0002 ) with rTPA ( -113.5 + /- 11.8 and -115.9 + /- 12.7 mm Hg for the first and second 2 months , respectively ) compared with heparin ( -136.5 + /- 23.3 and -134.7 + /- 25.8 mm Hg for the first and second 2 months , respectively ) . In addition , fewer complications ( flow problems , clotting , and need for fibrinolysis ) occurred in the rTPA period . These results show that rTPA is superior to heparin for priming the Quinton Permcath between hemodialysis sessions and can be used as a valuable alternative to conventional heparin in selected patients BACKGROUND Microinflammation is linked to cardiovascular disease , and is highly prevalent in dialysis patients . It is logical to postulate that septicemia , a common macroinflammatory occurrence in dialysis patients , contributes to their large burden of cardiovascular disease . METHODS The Dialysis Morbidity and Mortality Wave 2 was a r and omly selected prospect i ve cohort of incident dialysis patients . Admission cl aims data were used to define and calculate rates of septicemia or bacteremia and cardiovascular events in those with Medicare as the primary payer . Utilizing Cox proportional hazard models we determined the association between baseline access and the development of bacteremia or sepsis , and also the association between bacteremia or sepsis episodes and subsequent cardiovascular events . RESULTS The 2358 ( 59 % ) patients with Medicare as primary payer were older and more likely to have heart failure than those with other payers , but had similar comorbidity-adjusted mortality hazards . Rates of first septicemia , bacteremia , or either condition , were 7.0 , 5.9 and 10.4 events per 100-patient years , respectively . Cox regression identified initial dialysis access as the main antecedent of septicemia or bacteremia . Hazards ratios for hemodialysis with permanent catheters , temporary catheters , and grafts were 1.95 ( 95 % CI 1.47 - 2.57 ) , 1.76 ( 95 % CI 1.29 - 2.41 ) , and 1.05 ( 95 % CI 0.82 - 1.35 ) , respectively , while that for peritoneal dialysis was 0.96 ( 95 % CI 0.75 - 1.23 ) ( reference arteriovenous fistula ) . After adjustment for baseline factors , septicemia or bacteremia , as a time-dependent covariate , was associated with subsequent death [ hazards ratio ( HR ) 2.33 , 95 % CI 1.38 - 2.28 ] , myocardial infa rct ion ( HR 1.78 , 95 % CI 1.38 - 2.28 ) , heart failure ( HR 1.64 , 95 % CI 1.39 - 1.95 ) , peripheral vascular disease ( HR 1.64 , 95 % CI 1.34 - 2.0 ) , and stroke ( HR 2.04 , 95 % CI 1.27 - 3.28 ) . CONCLUSION Septicemia appears to be an important , potentially preventable , cardiovascular risk factor in dialysis patients Tinzaparin offers some advantages over unfractionated heparin ( UFH ) for hemodialysis circuit anticoagulation . No study has compared these two molecules as hemodialysis catheter lo
Output:
| In the few r and omized trials that met our inclusion criteria , the use of rt-PA as a locking solution for hemodialysis catheters seems to be associated with fewer adverse events and catheter malfunctioning as compared with heparin . |
MS212213 | ***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 A phase III multi-centre r and omised trial ( ROSEL ) has been initiated to establish the role of stereotactic radiotherapy in patients with operable stage IA lung cancer . Due to rapid changes in radiotherapy technology and evolving techniques for image-guided delivery , guidelines had to be developed in order to ensure uniformity in implementation of stereotactic radiotherapy in this multi-centre study . Methods / Design A Quality Assurance Working Party was formed by radiation oncologists and clinical physicists from both academic as well as non-academic hospitals that had already implemented stereotactic radiotherapy for lung cancer . A literature survey was conducted and consensus meetings were held in which both the knowledge from the literature and clinical experience were pooled . In addition , a planning study was performed in 26 stage I patients , of which 22 were stage 1A , in order to develop and evaluate the planning guidelines . Plans were optimised according to parameters adopted from RTOG trials using both an algorithm with a simple homogeneity correction ( Type A ) and a more advanced algorithm ( Type B ) . Dose conformity requirements were then formulated based on these results . Conclusion Based on current literature and expert experience , guidelines were formulated for this phase III study of stereotactic radiotherapy versus surgery . These guidelines can serve to facilitate the design of future multi-centre clinical trials of stereotactic radiotherapy in other patient groups and aid a more uniform implementation of this technique outside clinical trials PURPOSE To present the results of stereotactic body radiotherapy ( SBRT ) for medically inoperable patients with Stage I non-small-cell lung cancer ( NSCLC ) and contrast outcomes in patients with and without a pathologic diagnosis . METHODS AND MATERIAL S Between December 2004 and October 2008 , 108 patients ( 114 tumors ) underwent treatment according to the prospect i ve research ethics board-approved SBRT protocol s at our cancer center . Of the 108 patients , 88 ( 81.5 % ) had undergone pretreatment whole-body [18F]-fluorodeoxyglucose positron emission tomography/computed tomography . A pathologic diagnosis was unavailable for 33 ( 28.9 % ) of the 114 lesions . The SBRT schedules included 48 Gy in 4 fractions or 54 - 60 Gy in 3 fractions for peripheral lesions and 50 - 60 Gy in 8 - 10 fractions for central lesions . Toxicity and radiologic response were assessed at the 3 - 6-month follow-up visits using conventional criteria . RESULTS The mean tumor diameter was 2.4-cm ( range , 0.9 - 5.7 ) . The median follow-up was 19.1 months ( range , 1 - 55.7 ) . The estimated local control rate at 1 and 4 years was 92 % ( 95 % confidence interval [ CI ] , 86 - 97 % ) and 89 % ( 95 % CI , 81 - 96 % ) . The cause-specific survival rate at 1 and 4 years was 92 % ( 95 % CI , 87 - 98 % ) and 77 % ( 95 % CI , 64 - 89 % ) , respectively . No statistically significant difference was found in the local , regional , and distant control between patients with and without pathologically confirmed NSCLC . The most common acute toxicity was Grade 1 or 2 fatigue ( 53 of 108 patients ) . No toxicities of Grade 4 or greater were identified . CONCLUSIONS Lung SBRT for early-stage NSCLC result ed in excellent local control and cause-specific survival with minimal toxicity . The disease-specific outcomes were comparable for patients with and without a pathologic diagnosis . SBRT can be considered an option for selected patients with proven or presumed early-stage NSCLC PURPOSE To evaluate the efficacy and adverse effects of image-guided stereotactic body radiation therapy ( SBRT ) in central ly/superiorly located non-small-cell lung cancer ( NSCLC ) . MATERIAL S AND METHODS We delivered SBRT to 27 patients , 13 with Stage I and 14 with isolated recurrent NSCLC . A central /superior location was defined as being within 2 cm of the bronchial tree , major vessels , esophagus , heart , trachea , pericardium , brachial plexus , or vertebral body , but 1 cm away from the spinal canal . All patients underwent four-dimensional computed tomography-based planning , and daily computed tomography-on-rail guided SBRT . The prescribed dose of 40 Gy ( n = 7 ) to the planning target volume was escalated to 50 Gy ( n = 20 ) in 4 consecutive days . RESULTS With a median follow-up of 17 months ( range , 6 - 40 months ) , the crude local control at the treated site was 100 % using 50 Gy . However , 3 of 7 patients had local recurrences when treated using 40 Gy . Of the patients with Stage I disease , 1 ( 7.7 % ) and 2 ( 15.4 % ) developed mediastinal lymph node metastasis and distant metastases , respectively . Of the patients with recurrent disease , 3 ( 21.4 % ) and 5 ( 35.7 % ) developed mediastinal lymph node metastasis and distant metastasis , respectively . Four patients ( 28.6 % ) with recurrent disease but none with Stage I disease developed Grade 2 pneumonitis . Three patients ( 11.1 % ) developed Grade 2 - 3 dermatitis and chest wall pain . One patient developed brachial plexus neuropathy . No esophagitis was noted in any patient . CONCLUSIONS Image-guided SBRT using 50 Gy delivered in four fractions is feasible and result ed in excellent local control PURPOSE This study analyzed patients enrolled in two large , prospect ively r and omized trials of systemic chemotherapy ( adjuvant/palliative setting ) for non-small-cell lung Cancer ( NSCLC ) . The main objective was to determine if age and /or the burden of chronic medical conditions ( comorbidity ) are independent predictors of survival , treatment delivery , and toxicity . PATIENTS AND METHODS Baseline comorbid conditions were scored using the Charlson comorbidity index ( CCI ) , a vali date d measure of patient comorbidity that is weighted according to the influence of comorbidity on overall mortality . The CCI score ( CCIS ) was correlated with demographic data , ( ie , age , sex , race ) , performance status ( PS ) , histology , cancer stage , patient weight , hemoglobin , alkaline phosphatase , lactate dehydrogenase , outcomes of chemotherapy delivery ( ie , type , total dose , and dose intensity ) , survival , and response . RESULTS A total of 1,255 patients were included in this analysis . The median age was 61 years ( range , 34 to 89 years ) ; 34 % of patients were elderly ( at least 65 years of age ) ; and 31 % had comorbid conditions at r and omization . Twenty-five percent of patients had a CCIS of 1 , whereas 6 % had a CCIS of 2 or greater . Elderly patients were more likely to have a CCIS equal to or greater than 1 compared with younger patients ( 42 % v 26 % ; P < .0001 ) , as were male patients ( 35 % v 21 % ; P < .0001 ) and patients with squamous histology ( 36 % v 29 % ; P = .001 ) . Although age did not influence overall survival , the CCIS appeared prognostic ( CCIS 1 v 0 ; hazard ratio 1.28 ; 95%CI , 1.09 to 1.5 ; P = .003 ) . CONCLUSION In these large , r and omized trials , the presence of comorbid conditions ( CCIS > or = 1 ) , rather than age more than 65 years , was associated with poorer survival PURPOSE To compare the efficacy of three lung stereotactic body radiotherapy ( SBRT ) regimens in a large institutional cohort . METHODS Between 2004 and 2009 , 130 patients underwent definitive lung cancer SBRT to a single lesion at the Mallinckrodt Institute of Radiology . We delivered 18 Gy × 3 fractions for peripheral tumors ( n = 111 ) and either 9 Gy × 5 fractions ( n = 8) or 10 Gy × 5 fractions ( n = 11 ) for tumors that were central or near critical structures . Univariate and multivariate analysis of prognostic factors was performed using the Cox proportional hazard model . RESULTS Median follow-up was 11 , 16 , and 13 months for the 9 Gy × 5 , 10 Gy × 5 , and 18 Gy × 3 groups , respectively . Local control statistics for Years 1 and 2 were , respectively , 75 % and 50 % for 9 Gy × 5 , 100 % and 100 % for 10 Gy × 5 , and 99 % and 91 % for 18 Gy × 3 . Median overall survival was 14 months , not reached , and 34 months for the 9 Gy × 5 , 10 Gy × 5 , and 18 Gy × 3 treatments , respectively . No difference in local control or overall survival was found between the 10 Gy × 5 and 18 Gy × 3 groups on log-rank test , but both groups had improved local control and overall survival compared with 9 Gy × 5 . Treatment with 9 Gy × 5 was the only independent prognostic factor for reduced local control on multivariate analysis , and increasing age , increasing tumor volume , and poor performance status predicted independently for reduced overall survival . CONCLUSION Treatment regimens of 10 Gy × 5 and 18 Gy × 3 seem to be efficacious for lung cancer SBRT and provide superior local control and overall survival compared with 9 Gy × 5 OBJECTIVE Sublobar resection ( SR ) is commonly used for patients considered high risk for lobectomy . Nonoperative therapies are increasingly being reported for patients with similar risk because of perceived lower morbidity . We report 30- and 90-day adverse events ( AEs ) from American College of Surgeons Oncology Group Z4032 , a multicenter phase III study for high-risk patients with stage I non-small cell lung cancer . METHODS Data from 222 evaluable patients r and omized to SR ( n = 114 ) or SR with brachytherapy ( n = 108 ) are reported . AEs were recorded using the Common Terminology Criteria for Adverse Events , Version 3.0 , at 30 and 90 days after surgery . Risk factors ( age , percent baseline carbon monoxide diffusion in the lung [ DLCO% ] , percent forced expiratory volume in 1 second [ FEV1 % ] , upper lobe vs lower lobe resections , performance status , surgery approach , video-assisted thoracic surgery vs open and extent , and wedge vs segmentectomy ) were analyzed using a multivariable logistic model for their impact on the incidence of grade 3 or higher ( G3 + ) AEs . Respiratory AEs were also specifically analyzed . RESULTS Median age , FEV1 % , and DLCO% were similar in the 2 treatment groups . There was no difference in the location of resection ( upper vs lower lobe ) or the use of segmental or wedge resections . There were no differences between the groups with respect to " respiratory " G3 + AEs ( 30 days : 14.9 % vs 19.4 % , P = .35 ; 0 - 90 days : 19.3 % vs 25 % , P = .31 ) and " any " G3 + AEs ( 30 days : 25.4 % vs 30.6 % , P = .37 ; 0 - 90 days : 29.8 % vs 37 % , P = .25 ) . Further analysis combined the 2 groups . Mortality occurred in 3 patients ( 1.4 % ) by 30 days and in 6 patients ( 2.7 % ) by 90 days . Four of the 6 deaths were thought to be due to surgery . When considered as continuous variables , FEV1 % was associated with " any " G3 + AE at days 0 to 30 ( P = .03 ; odds ratio [ OR ] = 0.98 ) and days 0 to 90 ( P = .05 ; OR = 0.98 ) , and DLCO% was associated with " respiratory " G3 + AE at days 0 to 30 ( P = .03 ; OR = 0.97 ) and days 0 to 90 ( P = .05 ; OR = 0.98 ) . Segmental resection was associated with a higher incidence of any G3 + AE compared with wedge resection at days 0 to 30 ( 40.3 % vs 22.7 % ; OR = 2.56 ; P < .01 ) and days 0 to 90 ( 41.5 % vs 29.7 % ; OR = 1.96 ; P = .04 ) . The median FEV1 % was 50 % , and the median DLCO% was 46 % . By using these median values as potential cutpoints , only a DLCO% of less than 46 % was significantly associated with an increased risk of " respiratory " and " any " G3 + AE for days 0 to 30 and 0 to 90 . CONCLUSIONS In a multicenter setting , SR with brachytherapy was not associated with increased morbidity compared with SR alone . SR/SR with brachytherapy can be performed safely in high-risk patients with non-small cell lung cancer with low 30- and
Output:
| Tumour location ( central versus peripheral ) did not impact overall survival .
Grade 3 or 4 toxicities may be more common following SABR for central tumours , but occurred in less than 9 % of patients .
Post-SABR survival for early-stage NSCLC is not affected by tumour location .
SABR achieves high local control with limited toxicity when appropriate fractionation schedules are used for central tumours |
MS212214 | ***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 Reports indicate that the administration of epidural analgesia for pain relief during labor interferes with labor and increases cesarean deliveries . However , only a few controlled trials have assessed the effect of epidural analgesia on the incidence of cesarean delivery . The authors ' primary purpose in this r and omized study was to evaluate the effects of epidural analgesia on the rate of cesarean deliveries by providing a suitable alternative : patient-controlled intravenous analgesia . Methods Seven hundred fifteen women of mixed parity in spontaneous labor at full term were r and omly assigned to receive either epidural analgesia or patient-controlled intravenous meperidine analgesia . Epidural analgesia was maintained with a continuous epidural infusion of 0.125 % bupivacaine with 2 micro gram/ml fentanyl . Patient-controlled analgesia was maintained with 10 - 15 mg meperidine given every 10 min as needed using a patient-controlled pump . Procedures recorded in a manual that prescribed the intrapartum management were followed for each woman r and omized in the study . Results A total of 358 women were r and omized to receive epidural analgesia , and 243 ( 68 % ) of these women complied with the epidural analgesia protocol . Similarly , 357 women were r and omized to receive patient-controlled intravenous meperidine analgesia , and 259 ( 73 % ) of these women complied with the patient-controlled intravenous analgesia protocol . Only five women who were r and omized and received patient-controlled intravenous meperidine analgesia according to the protocol crossed over to epidural analgesia due to inadequate pain relief . There was no difference in the rate of cesarean deliveries between the two analgesia groups using intention-to-treat analysis based on the original r and omization ( epidural analgesia , 4 % [ 95 % CI : 1.9 - 6.2 % ] compared with patient-controlled intravenous analgesia , 5 % [ 95 % CI : 2.6 - 7.2 % ] ) . Similar results were observed for the analysis of the protocol -compliant groups ( epidural analgesia , 5 % [ 95 % CI : 2.6 - 8.5 % ] compared with patient-controlled intravenous analgesia , 6 % [ 95 % CI : 3 - 8.9 % ] ) . Women who received epidural analgesia reported lower pain scores during labor and delivery compared with women who received patient-controlled intravenous analgesia . Conclusions Epidural analgesia was not associated with increased numbers of cesarean delivery when compared with a suitable alternative method of analgesia OBJECTIVE This study was undertaken to determine whether a policy of delayed pushing for nulliparous women with continuous-infusion epidural analgesia reduces the risk of difficult delivery ( cesarean delivery , operative delivery from a midpelvic position , low-pelvic procedures with rotation > 45 degrees ) . STUDY DESIGN In this multicenter , r and omized , controlled trial women in the delayed pushing group ( n = 936 ) were advised to wait > or = 2 hours after full dilatation before commencement of pushing . Women in the early pushing group ( n = 926 ) were advised to commence pushing as soon as they had been r and omly assigned . RESULTS Difficult delivery was reduced with delayed pushing ( relative risk , 0.79 ; 95 % confidence interval , 0.66 - 0.95 ) . The greatest effect was on midpelvic procedures ( relative risk , 0.72 ; 95 % confidence interval , 0.55 - 0.93 ) . Although there was little evidence for an effect on low-pelvic procedures , spontaneous delivery was more frequent among women who practice d delayed pushing ( relative risk , 1.09 ; 95 % confidence interval , 1.00 - 1.18 ) . Abnormal umbilical cord blood pH ( < 7.15 venous value or < 7.10 arterial value ) was more frequent in the delayed pushing group ( relative risk , 2.45 , 95 % confidence interval , 1.35 - 4 . 43 ) . However , scores for a summary indicator , the Neonatal Morbidity Index , were similarly distributed in the 2 groups . CONCLUSION Delayed pushing is an effective strategy to reduce difficult deliveries among nulliparous women We compared the incidence of Caesarean delivery in nulliparous women r and omized to receive epidural analgesia with those r and omized to intramuscular ( i.m . ) pethidine . On admission to the delivery suite in established labour , 802 nulliparae had already agreed to be r and omized with respect to their first analgesia . One hundred and eighty-eight women required either no analgesia or 50 % nitrous oxide in oxygen ( Entonox ) only . Of the remaining 614 women , 310 were r and omly allocated to receive i.m . pethidine up to 300 mg and 304 to receive epidural bupivacaine . Labour management was st and ardized according to the criteria for active management of labour . The intention-to-treat analysis showed similar Caesarean section rates in those r and omized to epidural ( 12 % ) or pethidine analgesia ( 13 % ) . The difference in Caesarean rate was -1.1 % with 95 % confidence intervals from -6.3 % to + 4.1 % . The normal vaginal delivery rates were similar ( epidural , 59 % ; pethidine , 61 % ) The aim of this quasi‐experimental study was to examine the effects of maternal pethidine during labour on the developing breast feeding behaviour in infants in the first 2 h after birth compared with infants not exposed to pethidine . Forty‐four healthy infants were observed immediately after birth . They were placed skin‐to‐skin on their mothers ' chests . The development of mouth and sucking movements as well as rooting behaviour and state of sleep/wakefulness were noted . The observer was blind as to the pain relief the mother had received during labour . Of the 44 mothers 18 had received pethidine . The main findings were that infants exposed to pethidine had delayed and depressed sucking and rooting behaviour . In addition , a smaller proportion of infants exposed to pethidine started to suckle the breast . Rooting movements which are expected to be vigorous at 30 min after birth were affected both by administration of pethidine and a longer second stage of labour . It is suggested that the differences found in sucking behaviour may be a central effect of pethidine . Depression of rooting movements in the pethidine group may be caused by exhaustion due to a longer second stage of labour and administration of pethidine . It is recommended that pethidine‐exposed mother‐infant couples stay together after birth long enough to enable the infant to make the choice to attach or not to attach to the nipple without the forceful helping h and of the health staff Background Some studies suggest that epidural analgesia prolongs labor and increases the incidence of cesarean section , especially if it is administered before 5 cm cervical dilation . The purpose of the current study was to determine whether early administration of epidural analgesia affects obstetric outcome in nulliparous women who are receiving intravenous oxytocin . Methods Informed consent was obtained from healthy nulliparous women with a singleton fetus in a vertex presentation , who requested epidural analgesia while receiving intravenous oxytocin at at least 36 weeks ' gestation . Each patient was r and omized to receive either early or late epidural analgesia . R and omization occurred only after the following conditions were met : ( 1 ) the patient requested pain relief at that moment , ( 2 ) a lumbar epidural catheter had been placed , and ( 3 ) the cervix was at least 3 but less than 5 cm dilated . Patients in the early group immediately received epidural bupivacaine analgesia . Patients in the late group received 10 mg nalbuphlne intravenously . Late-group patients did not receive epidural analgesia until they achieved a cervical dilation of at least 5 cm or until at least 1 h had elapsed after a second dose of nalbuphine . Results Early administration of epidural analgesia did not prolong the interval between r and omization and the diagnosis of complete cervical dilation , and it did not increase the incidence of malposition of the vertex at delivery . Also , early administration of epidural analgesia did not result in an increased incidence of cesarean section or instrumental vaginal delivery . Thirteen ( 18 % ) of 74 women In the early group and 14 ( 19 % ) of 75 women in the late group underwent cesarean section ( relative risk for the early group 0.94 ; 95 % confidence interval 0.48–1.84 ) . Patients in the early group had lower pain scores between 30 and 120 min after r and omization , and were more likely to experience transient hypotension . Infants in the late group had lower umbilical arterial and venous blood pH and higher umbilical arterial and venous blood carbon dioxide tension measurements at delivery . Conclusions Early administration of epidural analgesia did not prolong labor or increase the incidence of operative delivery , when compared with intravenous nalbuphine followed by late administration of epidural analgesia , in nulliparous women who were receiving intravenous oxytocin Background : In 1981 , with support from the American Society of Anesthesiologists and the American College of Obstetricians and Gynecologists , anesthesia and obstetric providers were surveyed to identify the personnel and methods used to provide obstetric anesthesia in the United States . The survey was exp and ed and repeated in 1992 with support from the same organizations . Methods : Comments and questions from the American Society of Anesthesiologists Committee on Obstetrical Anesthesia and the American College of Obstetricians and Gynecologists Committee on Obstetric Practice were added to the original survey instrument to include newer issues while allowing comparison with data from 1981 . Using the American Hospital Association registry of hospitals , hospitals were differentiated by number of births per year ( stratum I , > or= to 1,500 births ; stratum II , 500–1,499 births ; stratum III , < 500 births ) and by U.S. census region . A stratified r and om sample of hospitals was selected . Two copies of the survey were sent to the administrator of each hospital , one for the chief of obstetrics and one for the chief of anesthesiology . Results : Compared with 1981 data , there was an overall reduction in the number of hospitals providing obstetric care ( from 4,163 to 3,545 ) , with the decrease occurring in the smallest units ( 56 % of stratum III hospitals in 1981 compared with 45 % in 1992 ) . More women received some type of labor analgesia , and there was a 100 % increase in the use of epidural analgesia . However , regional analgesia was unavailable in 20 % of the smallest hospitals . Spinal analgesia for labor was used in 4 % of parturients . In 1981 , obstetricians provided 30 % of epidural analgesia for labor ; they provided only 2 % in 1992 . Regional anesthesia was used for 78–85 % ( depending on strata ) of patients undergoing cesarean section , result ing in a marked decrease in the use of general anesthesia . Anesthesia for cesarean section was provided by nurse anesthetists without the medical direction of an anesthesiologist in only 4 % of stratum I hospitals but in 59 % of stratum III hospitals . Anesthesia personnel provided neonatal resuscitation in 10 % of cesarean deliveries compared with 23 % in 1981 . Conclusions : Compared with 1981 , analgesia is more often used by parturients during labor , and general anesthesia is used less often in patients having cesarean section deliveries . In the smallest hospitals , regional analgesia for labor is still unavailable to many parturients , and more than one half of anesthetics for cesarean section are provided by nurse anesthetists without medical direction by an anesthesiologist . Obstetricians are less likely to personally provide epidural analgesia for their patients . Anesthesia personnel are less involved in newborn resuscitation OBJECTIVE Intrathecal narcotics ( ITNs ) are being used in some setting s as a sole labor analgesic . However , they have not been directly compared to epidural analgesia . STUDY DESIGN We used a prospect i ve observational design . POPULATION Eighty-two women with uncomplicated full-term pregnancies were enrolled upon analgesia request during spontaneous labor with cervical dilation 3 to 7 cm . Sixty-three chose ITNs ( morphine and fentanyl ) , and 19 chose epidural analgesia ( continuous infusion of bupivacaine and fentanyl ) . OUTCOMES MEASURED Pain scores were documented using a visual analog scale . Satisfaction and side effects were rated with Likert scales during a structured interview on the first postpartum day . Outcomes were analyzed with multivariate regression techniques . RESULTS Intrathecal narcotics were associated with significantly higher pain scores than was epidural analgesia during the first and second stages of labor and on an overall postpartum rating . The median effective duration of action for ITNs was between 60 and 120 minutes ; however , ITNs provided excellent analgesia for a subgroup of women who delivered within 2 to 3 hours of receiving them . Although women in both groups were satisfied with their pain management , women receiving ITNs had statistically lower overall satisfaction scores . CONCLUSIONS Within the limitations of a nonr and omized study , a single intrathecal injection of
Output:
| Parenteral opioids provide modest pain relief in labor , and little evidence supports the use of one agent over another .
Although epidural analgesia is the most effective form of pain relief , its use is associated with a longer labor , an increased incidence of maternal fever , and increased rates of operative vaginal delivery .
The effect of epidural analgesia on rates of cesarean delivery is controversial .
Nitrous oxide provides a modest analgesic effect , but it is used less often in the United States than in other developed nations .
Paracervical block provides effective analgesia in the first stage of labor , but its use is limited by postblock bradycardia . |
MS212215 | ***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 a quasi-experimental study , hospital-treated traffic accident injuries were recorded prospect ively for 7 1/2 years in the two Norwegian cities , Harstad and Trondheim . In Harstad the recorded data were used actively in analysis , planning , and implementation of a community-based injury prevention program . Trondheim was the nonequivalent control city . The intervention was divided into three periods , each of 30 months duration . Preventive efforts were implemented to some extent in period 1 , increasingly in period 2 and period 3 . Traffic safety was promoted in an extensive community program based on the Ottawa charter for health promotion . A 26.6 % overall reduction of traffic injury rates was found in Harstad from period 1 to period 3 ( p < 0.01 ) , whereas a corresponding significant increase was found in the comparison city . Analysis of data from other sources were not conclusive in supporting the Trondheim data as showing the national trend . Alternative explanations for the injury rate reduction in Harstad were assessed by means of other available relevant data . The exact mechanisms that brought about the reduction of injury rates were hard to eluci date because so many intervention elements were implemented at the same time . It is concluded that at least some of the reduction was due to behavioural and structural changes brought about by health promotion . Important factors for the effect of and participation in the prevention program were local relevance and continuous feedback of accident injury data Parents of 171 children coming to the Yale-New Haven Hospital Primary Care Center for their 6-month checkup were r and omized into an intervention group ( n = 85 ) and a control group ( n = 86 ) . Parents in the intervention group received a three-part individualized course in child safety that required active parental participation . Parts 1 , 2 , and 3 were given at the 6-month , 9-month , and 12-month well-child visits , respectively . Parents in the control group received routine safety education as provided at well-child visits . The educational phase of the study was completed by 129 families , 65 in the intervention group and 64 in the control group . Safety knowledge , number of hazards in the home , and reported accidents were assessed by a " blinded " community health worker approximately 1 month after the 12-month well-child visit . A total of 109 home visits were made , 55 for the intervention group and 54 for the control group . Parental safety knowledge was assessed based upon pictorial hazard recognition . Of 13 possible hazards , the mean number of hazards recognized by the intervention group parents was 9.4 ( n = 55 ) v 8.4 ( n = 50 ) by the control group parents ( t = 2.1 , P less than .05 , two-tailed ) . A hazard score was determined for each family based on nine possible hazards observed at the home visit . The mean hazard score for the intervention group was 2.4 ( n = 55 v 3.0 ( n = 54 ) for the control group ( t = 2.4 , P less than .02 , two-tailed ) . Parentally reported accidents and accidents reported in hospital records were similar for both groups . Results of this study suggest that age-appropriate safety education that is repetitive and individualized and that requires active parental participation results in an increase in parental knowledge and an improvement in certain safety practice OBJECTIVE To determine the effectiveness of a safety education program , Safety City , that is design ed to teach kindergarten and first grade children how to cross the street , call 911 in an emergency , and avoid strangers . PARTICIPANTS / SETTING Kindergarten students at 10 urban elementary schools . DESIGN Each school was r and omized to either the intervention or control group . An evaluation tool was administered to all participants as a pretest . The Safety City program was then presented to the intervention schools . Afterward , the same evaluation tool was used as a post-test . The posttest was administered to the intervention group 6 months after the Safety City program was presented . The control group took the posttest 6 months after the pretest . MAIN OUTCOME MEASURE Change in individual test scores . RESULTS One hundred eighty-one children completed the pretest and posttest evaluations . There was no statistical difference in the change between pretest and posttest scores of children who participated in the Safety City program and those in the control group ( crossing the street , P = .29 ; calling 911 , P = .41 ; stranger avoidance , P = .57 ) . CONCLUSIONS Exposure to the Safety City program did not achieve the desired changes in safety knowledge among participants . This is most likely owing to the fact that Safety City attempts to convey a large amount of relatively complex information to young children in a brief period . We conclude that programs such as Safety City are not sufficient to teach children these behaviors . This report also emphasizes the importance of building an evaluation component into educational programs Summary . Trends in road casualty figures among children in recent years are evaluated and interpretations suggested . The experiment reported here shows that the educator 's conception of the function of the kerb drill , i.e. , to detect traffic , is not reflected in its function as perceived by many young children , who in the experimental setting behave as though they regarded the performance of the kerb drill as in itself sufficient to ward off the dangers of the road . The experiment also demonstrates that the notions of directionality which the kerb drill presupposes are not those of 5–6-year-old children , who often regard ‘ left ’ and ‘ right ’ as parts of the environment rather than relations to the person . The ‘ static ’ conception of directionality becomes more frequent after exposure to a propag and a film in which the kerb drill exemplars perform facing their audience OBJECTIVE To test the feasibility of a hospital-based injury recording for accident analysis and outcome evaluation of bicyclist and pedestrian injury prevention . DESIGN Prospect i ve injury recording lasting 7 1/2 years , using a quasi-experimental design . SETTING The population of Harstad ( 22,000 ) . INTERVENTION Injury data were evaluated in an injury prevention group and used in planning a community-based intervention . Promotion of bicyclist helmet use and pedestrian safe behaviour was implemented by activating public and voluntary organizations and media . A traffic safety pamphlet containing local traffic injury data was distributed . Changes were made in the physical traffic environment . MAIN OUTCOME MEASURES Injury rates for bicyclists and pedestrians . RESULTS In 275 bicyclists upper extremity and head injuries were predominant 70 % were below 16 years . In 137 pedestrians lower extremity injury was most frequent and children below 10 years had the highest injury rates . Significant injury rate reductions were observed after intervention for child bicyclists and pedestrians . CONCLUSION A hospital-based injury recording is feasible for bicyclists and pedestrian accident analysis , planning injury prevention , and outcome evaluation of the programme . This study indicates that a significant injury rate reduction in children may have been the result of the intervention HYPOTHESIS Young children can learn safety behavior in the public school system . These children will modify family seat belt use . SETTING DESIGN : This is a prospect i ve cohort analytic study conducted in a 50,000 square mile regionalized trauma center referral area . METHODS A school-based injury prevention program targeting kindergarten through second- grade ( K-2 ) students addressed four aspects of traffic safety : seat belt use , pedestrian and bicycle safety , school bus safety , and unsafe rides . After inservice instruction , teachers taught the program over a 10-week period . A simultaneous community traffic safety program was conducted through the media . Family seat belt use was monitored by blinded observation at six study schools and one control school . Income level of schools was characterized as low or high , based on student use of federal lunch subsidies . School program implementation was defined as good or poor , based on adherence to teaching protocol . RESULTS A total of 68,650 K-2 students have completed this traffic safety program during 1990 to 1994 . During the study year ( 1992 to 1993 ) , 25,900 students completed the program taught by 1,400 teachers in 95 schools . A total of 5,936 observations of seat belt use were made in seven schools . Income stratification delineated a subset of these schools in which seat belt use increased by 86 % ( p = 0.01 ) . Half of the schools failed to follow protocol , and no change in seat belt use was observed . CONCLUSIONS ( 1 ) School K-2 safety education improves family seat belt use , ( 2 ) low income schools should be targeted , and ( 3 ) strict adherence to the teaching protocol is essential Using a simulation game design ed to teach children to obey certain traffic safety rules , an experimental study was conducted with 136 five-year-old children in four Quebec schools . Within each classroom , subjects were r and omly divided into four groups : three intervention groups and one control group . Each of the experimental groups was subjected to a different intervention with outcome measured using three instruments related to attitudes , behavior , and transfer of learning of pedestrian traffic safety . Results suggest that simulation games including role-playing/group dynamics and modeling/training can change attitudes and modify behavior in the area of pedestrian traffic safety in children of this age BACKGROUND Programmes design ed to teach children about road safety have often failed to assess their effectiveness in terms of either an increase in children 's knowledge or an improvement in children 's behaviour . AIM The two studies reported here sought to address both issues , by focusing on the abilities of Primary 1 children ( 5 years old ) . SAMPLE A total of 120 Primary 1 children within the age range 4 - 5 years old participated in this study , drawn from three different primary schools within an educational district of Scotl and . METHODS In the first study the effects of three different road safety interventions were tested , all of which employed commercially marketed products : 1 ) a three-dimensional model of the traffic environment ; 2 ) a road safety board game ; and 3 ) illustrated posters and flip-chart material s. In the second study the transfer of knowledge to children 's behaviour in a real-life traffic environment was tested , using a sub sample of 47 children who had taken part in the first study . RESULTS Results from the first study showed , surprisingly , that all three interventions were effective in increasing children 's knowledge about safe and dangerous locations at which to cross the street , and that this knowledge was retained for a period of six months . Study 2 , however , showed that increased knowledge did not result in improved traffic behaviour . Children who had received training performed no better than children in a control group . CONCLUSION These findings highlight the need to distinguish between children 's road safety knowledge and their behaviour , particularly for teachers and parents , who may mistakenly believe that children who know more will be safer on the road Abstract Pedestrian-skills training procedures were compared using 30 mentally retarded institutionalized adults . Ten subjects were r and omly assigned to a no-treatment control group and ten subjects were assigned to each of two modes of pedestrian-skills training . The training methods included a form of individualized classroom training consisting of the practice of correct behavior using movable figures on a scale model of an intersection , vs independence training which emphasized self-evaluation of performance , social reinforcement , sign recognition and the utilization of a mock-up of an intersection on the hospital grounds . Data were taken on sign recognition , verbal and performance based responses to classroom training of pedestrian skills , performance of skills at an intersection on the hospital grounds , and performance of pedestrian skills in the community . Independence training proved to be significantly more effective than no treatment or classroom training . In addition , classroom training proved to be significantly more effective than no treatment at all A r and omized pretest and posttest comparative design was used to evaluate the outcome of implementing Think First for Kids ( TFFK ) , an injury prevention program for children grade s 1 , 2 , and 3 , among intervention and controls schools . The study showed that children often lack basic knowledge regarding safety and do not recognize behaviors considered high risk for injury . By using multivariate analysis , the intervention children had a significantly greater increase in knowledge about the brain and spinal cord and safe behaviors to prevent traumatic injury , and a decrease in self-reported , high-risk behaviors ( p < .001 ) when compared with control subjects , adjusting for the covariates gender , socioeconomic status , and race/ethnicity . African American and Hispanic children , although displaying the lowest test scores at baseline , had the largest absolute improvement in posttest scores . The TFKK prevention program addresses the leading causes of trauma among children including sports , motor vehicle crashes , falls , drowning , and pedestrian injuries Methods of confidence interval construction are provided for summary measures of treatment effect arising from design s r and omizing clusters to one of two treatment groups . Three basic design s are considered for the case of continuous and dichotomous variables : completely r and omized , pair-matched and stratified
Output:
| Some of these trials showed evidence of behavioural change following pedestrian safety education but it is difficult to predict what effect this might have on pedestrian injury risk .
REVIEW ER 'S CONCLUSIONS Pedestrian safety education can result in improvement in children 's knowledge and can change observed road crossing behaviour but whether this reduces the risk of pedestrian motor vehicle collision and injury occurrence is unknown . |
MS212216 | ***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: Prospect i ve assessment of lymph node status , based on the findings of computed tomography , external ultrasonography and palpation , was compared with clinical results in 179 patients who underwent oesophagectomy with systematic node dissection . Preoperative findings for each node group were classified into four grade s : involvement not suspected ( − ) ; possible involvement ( ± ) ; probable involvement ( + ) ; and definite involvement ( + + ) . When only ( + + ) or ( + ) assessment was categorized as positive , the specificity was more than 94 per cent , although the sensitivity was less than 40 per cent . The preoperative assessment correlated significantly with the incidence of node involvement ( P < 0·02 ) , the degree of lymphatic invasion ( P < 0·0001 ) and outcome after operation . For patients with all nodes assessed as ( − ) , the 5‐year survival rate was 70 per cent , compared with 26 per cent for those with nodes assessed as ( + ) , P = 0·001 . Preoperative assessment provided useful information on nodal status PURPOSE To evaluate the value of external ultrasonography ( US ) of the neck in current dedicated preoperative staging of patients with cancer of the esophagus and gastroesophageal junction ( GEJ ) . MATERIAL S AND METHODS We analyzed 180 consecutive patients ( 154 men , 26 women , and mean age 63 ( 38 - 84 ) years ) without palpable cervical lymphadenopathy , treated between January 2001 and March 2006 . Suspicious lesions were confirmed by cytological examination . All first 125 consecutive patients ( group A ) were staged by st and ard endoscopic ultrasonography ( EUS ) , multidetector computed tomography ( md-CT ) , positron emission tomography with (18)F-fluorodeoxyglucose ( FDG-PET ) and external US . The other 55 patients ( group B ) were prospect ively staged according to a revised protocol consisting of routine EUS and md-CT , while PET was only performed in subjects with T3-T4 and /or N1 disease and external US solely on indication . RESULTS Cervical metastases were found in seven patients from group A ( 6 % ) and in five from group B ( 9 % ) . Twenty percent ( 4/20 ) of the tumors above the carina and 5 % ( 8/160 ) of the distal tumors presented with cervical metastases . All were diagnosed as T3 and T4 tumors on EUS . Eleven of these metastases were detected by external US and nine on md-CT . All nodal metastases were detected by the combination of PET and md-CT . No cervical metastases were missed by the diagnostic algorithm in group B. CONCLUSION In present staging procedures for esophageal cancer , routine external US seems to have no additional value in detecting cervical metastases . It is still indicated to obtain cytological proof of suspected cervical lesions BACKGROUND AND OBJECTIVE A range of fixed-effect and r and om-effects meta-analytic methods are available to obtain summary estimates of measures of diagnostic test accuracy . The hierarchical summary receiver operating characteristic ( HSROC ) model proposed by Rutter and Gatsonis in 2001 represents a general framework for the meta- analysis of diagnostic test studies that allows different parameters to be defined as a fixed effect or r and om effects within the same model . The Bayesian method used for fitting the model is complex , however , and the model is not widely used . The objective of this report is to show how the model may be fitted using the SAS procedure NLMIXED and to compare the results to the fully Bayesian analysis using an example . METHODS The HSROC model , its assumptions , and its interpretation are described . The advantages of this model over the usual summary ROC ( SROC ) regression model are outlined . A complex example is used to compare the estimated SROC curves , expected operating points , and confidence intervals using the alternative approaches to fitting the model . RESULTS The empirical Bayes estimates obtained using NLMIXED agree closely with those obtained using the fully Bayesian analysis . CONCLUSION This alternative and more straightforward method for fitting the HSROC model makes the model more accessible to meta-analysts Objective To determine the prevalence of occult cervical nodal metastases in patients with squamous cell cancer and adenocarcinoma of the esophagus , and to determine the impact of esophagectomy with three-field lymph node dissection on survival and recurrence rates . Summary Background Data Although esophagectomy with three-field lymph node dissection is commonly practice d in Japan , its role in the surgical management of esophageal cancer in the United States , especially in patients with esophageal adenocarcinoma , is essentially unknown . Methods This is a prospect i ve observational study of esophagectomy with three-field lymphadenectomy . Eighty patients underwent resection between August 1994 and April 2001 . Clinicopathological information and follow-up data were collected on all patients until death or June 2001 . Results Hospital mortality and morbidity rates were 5 % and 46 % , respectively . Metastases to the recurrent laryngeal and /or deep cervical nodes occurred in 36 % of patients irrespective of cell type ( adenocarcinoma 37 % , squamous 34 % ) or location within the esophagus ( lower third 32 % , middle third 60 % ) . Overall 5-year and disease-free survival rates were 51 % and 46 % , respectively . Sixty-nine percent presented with nodal metastases . The 5-year survival rate for node-negative patients was 88 % ; that for those with nodal metastases was 33 % . The 5-year survival rate in patients with positive cervical nodes was 25 % ( squamous 40 % , adenocarcinoma 15 % ) . Conclusions Esophagectomy with three-field lymph node dissection can be performed with a low mortality and reasonable morbidity . Unsuspected metastases to the recurrent laryngeal and /or cervical nodes are present in 36 % of patients regardless of cell type or location within the esophagus . Thirty percent of patients were upstaged , mainly from stage III to stage IV . An overall 5-year survival rate of 51 % suggests a true survival benefit beyond that achieved solely on the basis of stage migration BACKGROUND AND OBJECTIVES Both ultrasound ( US ) and computed tomography ( CT ) can be used to detect supraclavicular lymph node metastases . Aim was to compare US , US plus fine-needle aspiration ( US-FNA ) , CT , US + CT , and US-FNA + CT for the detection of these metastases in esophageal or gastric cardia cancer patients . METHODS Between 1994 and 2004 , 567 patients underwent US and CT for esophageal or gastric cardia cancer staging . Gold st and ard was postoperative detection of lymph nodes in the resected specimen , FNA , or a radiological result with follow-up . RESULTS Sensitivities of US ( 75 % ) , US-FNA ( 72 % ) , US + CT ( 80 % ) , and US-FNA + CT ( 79 % ) were higher than sensitivity of CT alone ( 25 % ) ( P < 0.001 ) . Specificities were high for US-FNA ( 100 % ) , CT ( 99 % ) , and US-FNA + CT ( 99 % ) , whereas those of US alone ( 91 % ) and US + CT ( 91 % ) were lower ( P < 0.001 ) . In 4/65 ( 6 % ) patients with true-positive malignant lymph nodes , CT was positive with US and /or US-FNA being negative . However , in 36/65 ( 55 % ) patients , US and /or US-FNA were positive with CT being negative . CONCLUSION US-FNA seems the preferred diagnostic modality for the detection of supraclavicular lymph node metastases in patients with esophageal or gastric cardia cancer . Sensitivity of metastases detection only slightly improves if US-FNA is combined with CT . A prospect i ve , comparative study is however needed BACKGROUND AND OBJECTIVE Publication bias and other sample size effects are issues for meta-analyses of test accuracy , as for r and omized trials . We investigate limitations of st and ard funnel plots and tests when applied to meta-analyses of test accuracy and look for improved methods . METHODS Type I and type II error rates for existing and alternative tests of sample size effects were estimated and compared in simulated meta-analyses of test accuracy . RESULTS Type I error rates for the Begg , Egger , and Macaskill tests are inflated for typical diagnostic odds ratios ( DOR ) , when disease prevalence differs from 50 % and when thresholds favor sensitivity over specificity or vice versa . Regression and correlation tests based on functions of effective sample size are valid , if occasionally conservative , tests for sample size effects . Empirical evidence suggests that they have adequate power to be useful tests . When DORs are heterogeneous , however , all tests of funnel plot asymmetry have low power . CONCLUSION Existing tests that use st and ard errors of odds ratios are likely to be seriously misleading if applied to meta-analyses of test accuracy . The effective sample size funnel plot and associated regression test of asymmetry should be used to detect publication bias and other sample size related effects BACKGROUND Exact clinical staging before treatment of esophageal cancer has become increasingly important in the evaluation and comparison of the results of different treatment modalities , including surgery , chemotherapy , and radiotherapy . METHODS The accuracy of preoperative tumor staging by using an esophagography , esophagoscopy , percutaneous and endoscopic ultrasonography , and computed tomography was assessed in 224 patients with resectable esophageal cancer . The results of tumor staging by these tests were compared prospect ively with the pathologic stage of the esophagectomy specimens with respect to the T and N categories defined by the International Union Against Cancer TNM classification . RESULTS For the T category , the overall accuracy was 80 % . For the N category , overall accuracy was 72 % , with a sensitivity of 78 % , a specificity of 60 % , and a positive predictive value of 78 % . Overall , the accuracy of stage grouping was 56 % . CONCLUSIONS Either the T or N categories can be predicted reliably by clinical staging techniques . However , the preoperative stage grouping might not be valid in resectable , localized esophageal cancer Objective To determine the impact of radical node dissection on the recurrence patterns and survival rates of patients with carcinoma of the esophagus . Summary Background Data The role of esophagectomy with radical lymphadenectomy in the treatment of esophageal cancer is controversial . Most centers favor a limited operation with no attempt at nodal clearance . However , disease recurrence and patient survival rates remain dismal with or without preoperative therapy . The authors postulate that a more radical node dissection would reduce local failure rates and enhance survival . Methods One hundred eleven patients with esophageal cancer underwent en bloc esophagectomy with radical lymph node dissection between 1988 and 1998 . In 90 % of patients the procedure was applied nonselectively and without any preoperative therapy . Patients were prospect ively followed up for recurrence patterns and survival . Results The 5-year survival rate including noncancer deaths was 40 % . The 5-year survival rates for patients with stage 1 , 2A , 2B , 3 , and 4 disease were 78 % , 72 % , 0 % , 39 % , and 27 % , respectively . Forty percent of patients had node-negative disease ( 5-year survival rate , 75 % ) , and 60 % had nodal metastases ( 5-year survival rate , 26 % ) . Recurrence occurred in 39 % of patients and was local in only 8 % . Conclusions Radical esophagectomy results in superior overall and stage-specific 5-year survival rates . Extensive node dissection has a positive impact on survival rates , particularly in patients with nodal metastases AIM This study evaluates the use of neck ultrasound in staging squamous oesophageal carcinoma . MATERIAL S AND METHODS A prospect i ve analysis of the clinical , neck ultrasound ( US ) and thoraco-abdominal computed tomography ( CT ) findings in 121 patients with squamous oesophageal carcinoma at presentation was performed . The relationship between malignant neck nodes , mediastinal and abdominal adenopathy , location and size of the primary tumour was analysed . RESULTS Ten of 121 patients ( 8 % ) had clinical ly palpable neck nodes which were deemed malignant in six ( 5 % ) following US and fine-needle aspiration for cytology . Of those 111 patients with no palpable neck nodes , 31 ( 28 % ) had malignant nodes shown on US . The more cephalad the location of the primary tumour , the higher the frequency of malignant neck nodes which were found in 80 % , 52 % , 29 % and 9 % of cervical , upper thoracic , mid-thoracic and lower thoracic oesophageal tumours , respectively . Eleven ( 29 % ) of the 38 patients with malignant neck nodes shown on US had no CT evidence of additional adenopathy in the mediastinum or upper abdomen . Neck US altered TNM staging in 22/121 ( 18 % ) patients at presentation . CONCLUSION Neck US frequently detects clinical ly impalpable metastatic nodes leading to altered TNM staging in patients with squamous oesophageal
Output:
| Our analysis shows that ultrasonography may be an effective and reliable approach to detect cervical lymph node metastasis in esophageal cancer . |
MS212217 | ***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 This study describes patients ' perceptions of changes in oral health related quality of life ( OHQOL ) in the early postoperative period following third molar surgery . Methods One hundred patients were enrolled in a prospect i ve cohort study of the surgical removal of lower third molars under local anaesthetic . Two specific oral health related quality of life measures , OHIP-14 and OHQoLUK Results Both oral health related quality of life measures identified a significant deterioration in quality of life on POD1 ( P<0.01 ) and this remained evident on POD2 ( P<0.01 ) , POD3 ( P<0.01 ) , POD4 ( P<0.01 ) and POD5 ( P<0.05 ) . By POD6 and POD7 there was no significant difference in quality of life compared with preoperative status ( P>0.05 ) . Deterioration in life quality over the study period was associated with postoperative clinical findings ( P<0.05 ) : swelling and trismus . Conclusion The study concludes that there is a significant deterioration in oral health related quality of life in the immediate postoperative period following third molar surgery ; particularly during the first five days . This is associated with postoperative clinical findings . This has implication for patients deciding on third molar surgery and informed consent Aim The aim of this study was to evaluate the changes in oral health-related Quality of Life ( QoL ) following third molar surgery with either oral administration or submucosal injection of prednisolone . Patient and methods Subjects were r and omly distributed into three groups of 62 subjects each : Group A consisted of subjects who received 40 mg oral prednisolone ; group B received 40 mg submucosal injection of prednisolone , while group C did not receive prednisolone . Preoperative and postoperative quality of life evaluations of all subjects were done using the 14-item Oral Health Impact Profile ( OHIP-14 ) question naire . Postoperatively , quality of life evaluation was done on postoperative days 1 , 3 , and 7 . Subjects were categorized as either affected ( OHIP score ≤28 ) or not affected ( OHIP score > 28 ) . Mean OHIP scores between preoperative and postoperative periods , as well as between the three groups , were compared . Results A significant increase in the mean total and subscale scores was found in all the groups postoperatively . This was most marked on the first postoperative day , and it gradually improved throughout the immediate postoperative period . Subjects who received prednisolone experienced a statistically significant better quality of life than those who did not . Subjects who received submucosal injection of prednisolone showed statistically significant less deterioration in QoL than those who received oral prednisolone ( P = 0.001 ) . Conclusion Administration of prednisolone was significantly associated with less deterioration in quality of life and earlier recovery when compared with subjects who did not receive prednisolone . Submucosal injection of prednisolone 40 mg ( which offers a simple , safe , painless , and cost-effective therapeutic option ) is an effective therapeutic strategy for improving the quality of life after surgical removal of impacted lower third molars PURPOSE This study was design ed to assess the impact of " pain and swelling " associated with third molars on patients ' quality of life before surgery . PATIENTS AND METHODS The data for these analyses were obtained from a larger ongoing study design ed to examine the surgical and medical management of problems associated with third molars . Data from 480 patients with 4 third molars scheduled for removal were used in the analysis . Question naires administered presurgery assessed patients ' medical and dental history , their reasons for seeking third molar removal , and sociodemographic characteristics . Adverse impacts on oral health-related quality of life were measured using the 14-item Oral Health Impact Profile ( OHIP ) question naire . The primary outcome variable was the percentage of people reporting 1 or more of the 12 non-pain-specific OHIP items " fairly often " or " very often " during the 3 months before enrollment . RESULTS One third ( 178 of 480 ) of patients said they were seeking third molar surgery because of current or previous symptoms of pain/swelling , and 17 % reported 1 or more of the 12 non-pain-specific OHIP items . In the multivariate logistic regression model , the odds of one or more impacts was greater for people who presented because of symptoms ( odds ratio [ OR ] , 2.9 ; 95 % confidence interval [ CI ] , 1.7 to 4.8 ) , who were aged 25 years or more ( OR , 1.9 ; 95 % CI , 1.1 - 3.3 ) , and who had a self-reported history of tooth loss due to pathology or trauma ( OR , 2.9 ; 95 % CI , 1.9 to 5.5 ) . CONCLUSIONS Adverse impacts on quality of life occurred for 1 in 8 patients seeking third molar surgery , and the odds increased 3-fold for patients who had experienced pain/swelling compared with those who were asymptomatic Background This study aim ed to evaluate the patient 's pain and quality of life after suture removal at either 3 or 7 days following the bilateral surgical extraction of impacted lower third molars . Methods This study was a prospect i ve , r and omized controlled clinical trial carried out in 30 patients , who acted as their own control . Each patient required the bilaterally impacted m and ibular third molars to be extracted . The impacted teeth were removed and the wound margins were approximated and sutured with black braided silk . The suture material was removed on day 3 on one side and on day 7 on the other . Each participant was asked to complete a question naire after the removal of the suture material on each design ated day . Results Regarding overall clinical symptoms , the mean VAS scores of male and female participants on day 3 were not significantly different from those on day 7 . A significant difference was found in female participants , in that overall daily activity was better on day 7 . There were significant differences in the ability to smile and laugh in both sexes and the ability to chew in the male participants was better on day 7 . Conclusions There were no significant differences in the patient 's pain and quality of life between suture removal on day 3 or on day 7 following surgery to remove impacted lower third molars PURPOSE The aim of this study was to verify possible associations between oral health-related quality of life ( QoL ) and the position of the lower third molar among patients undergoing lower third molar surgery during the first postoperative week . MATERIAL S AND METHODS We performed an interventional prospect i ve study of 86 patients for whom the preoperative treatment plan included the removal of 2 third molar teeth from the same side in a 1-time procedure . The patients were divided into 2 groups depending on the position of the lower third molar . QoL was evaluated before and after the surgical procedure ( during the first 7 days ) with the Oral Health Impact Profile ( OHIP ) 14 question naire . Data were treated according to Stata 10.0 ( StataCorp , College Station , TX ) . Variables were evaluated by use of split-plot analysis of variance for the repeated- measures analysis to identify the association between QoL and the position of the lower third molar . RESULTS Patients can have deterioration in their QoL immediately after surgery , especially during the first and second postoperative days , and subsequently show rapid improvement . The variation in the total OHIP score during the days after surgery was significant , whereas a decrease in QoL was observed immediately after the procedure ( P = .001 ) , which returned to initial value ( preoperative ) levels after the sixth postoperative day . The OHIP domains with higher scores ( ie , those that had an impact ) were physical pain , psychological discomfort , and physical disability ( domains 2 , 3 , and 4 , respectively ) . CONCLUSIONS Teeth considered to be associated with technical difficulties for extraction based on their position had a higher score on the OHIP-14 question naire and worse health-related QoL score . QoL outcomes may be as important as clinical signs in decisions regarding third molar extraction Cold therapy is a conventional and widely used modality for reducing pain , trismus , and oedema after dentoalveolar surgeries . However , information reported in the literature on its effectiveness is insufficient and controversial . This study was performed to evaluate the effect of local cold application in reducing pain , trismus , and swelling after impacted m and ibular third molar surgery . Thirty patients ( seven males and 23 females ) with bilateral symmetrical m and ibular impacted third molars were enrolled in this r and omized , self-controlled , observer-blind clinical trial . The patients were aged between 18 and 30 years . After surgical removal of the tooth on one side ( intervention ) , ice pack therapy was given for 24h after surgery ; for the other side ( control ) , no cold therapy was given . The time interval between the two surgeries was at least 4 weeks . The amount of pain , trismus , and facial swelling was measured on days 2 and 7 postoperative , and patient satisfaction with the cold therapy vs. no cold therapy was assessed . The amount of pain , trismus , and facial swelling , and the extent of patient satisfaction were not significantly different between the intervention and control sides . Cold therapy had no beneficial effects on postoperative sequelae after impacted m and ibular third molar surgery The aim of this study was to evaluate the efficacy of electro-acupuncture ( EAC ) on postoperative pain control after m and ibular third molar surgery . Twenty four young patients ( 12 male and 12 female ) with symmetrically impacted m and ibular third molars were selected . Each patient was su bmi tted to two separate surgical procedures under local anesthesia . At one side , extraction was carried out employing both prior ( 24h ) and immediately postoperative application of EAC , while on the contralateral side surgery was carried out without any treatment . EAC was applied on 6 bilateral systemic and 2 auricular points with a WQ10Dl appliance using 40 - 60Hz frequency for 20 min and individually adjusted intensity . Postoperative pain intensity was rated on a 100 mm visual analog scale ( VAS ) between 2 and 72 h and recording the amount of analgesics intake after surgery . Statistical analysis was performed using theWilcoxon test . Postoperative pain VAS scores were significantly lower for the EAC group ( p<0.05 ) and analgesic intake decreased ( p<0.05 ) for all evaluated periods ( p<0.05 ) . Under the tested conditions EAC therapy is efficient was proved controlling postoperative pain following m and ibular third molar surgical removal This study aims to evaluate the efficacy of the ozone and laser application in the management of pain , swelling , and trismus after third-molar surgery . Sixty consecutive patients with asymptomatic impacted m and ibular third molars were recruited into the study . Patients were r and omized into three treatment groups of 20 patients each : two study groups ( group 1 = low-level laser therapy ( LLLT ) , group 2 = ozone therapy ) and a control group ( no-LLLT or ozone therapy ) . Twenty teeth extraction s were performed in each group . Evaluations of postoperative pain , the number of analgesics tablets taken , trismus , swelling , and quality of life ( Oral Health Impact Profile-14 question naire ) were made . The sample consisted of 28 female and 32 male patients , whose total mean age was 23.5 ± 3.4 ( range , 18–25 ) years . The pain level and the number of analgesics tablets taken were lower in the ozonated and LLLT applied groups than in the control group . This study showed that ozone and low power laser therapies had a positive effect on the patients ’ quality of life . Trismus in the LLLT group was significantly less than in the ozonated and control groups ( p = 0.033 ) . Ozone application showed no superiority in regards of postoperative swelling ; however , LLLT group had significantly lower postoperative swelling . This study demonstrates that ozone and laser therapies are useful for the reduction of postoperative pain and they increase quality of life after third-molar surgery . Although the ozone therapy had no effect on postoperative swelling and trismus after surgical removal of impacted lower third molars , LLLT had a positive effect BACKGROUND Oral and Maxillofacial operations can be extremely frightening treatment situations . General data on this phenomenon should be acquired through a multi-centre trial . METHOD A 10-page question naire was developed which was answered by 600 oral and maxillofacial patients before individual treatment . Control groups consisted of 800 surgical , dental and general practitioners/internal medicine patients . Twenty six medical practice s and hospital departments in 11 German cities were involved in the trial . RESULTS Both subjective anxiety assessment by patients and objective testing ( State Trait Anxiety Inventory ; STAI ) indicated a high level of treatment anxiety for oral and maxillofacial treatment situations . Oral and Maxillofacial Surgery ( OMFS ) patients ' scores were significantly higher than those of control groups . Especially younger and female patients , patients treated under local anaesthesia and out- patients showed intensive anxiety . Previous treatment experience in OMFS did not modify test results . CONCLUSION Managing perioperative anxiety is still a major challenge in OMFS . Irrespective of technical , pharmacological and surgical advances , developing and establishing stress-reducing and anxiolytic perioperative techniques is of considerable importance for both patients and surgeons Abstract Introduction Third molar surgery ( TMS ) became a routine , safe office procedure with generally predictable outcomes and relative low cost . It affects quality of life ( QOL ) of patients by causing considerable pain , swelling and trismus ; by changing what people eat , their speech in the first few days after surgery . The purpose of the present study was to improve QOL of patient after lower TMS by injecting single dose 8 mg submucosal dex
Output:
| Conclusion This systematic review revealed that the highest negative impact on quality of life of individuals su bmi tted to third molar surgery was observed on the first postoperative day , decreasing over the follow-up period |
MS212218 | ***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: Pesticides are a collective term for a wide array of chemicals intended to kill unwanted insects , plants , molds , and rodents . Food , water , and treatment in the home , yard , and school are all potential sources of children ’s exposure . Exposures to pesticides may be overt or subacute , and effects range from acute to chronic toxicity . In 2008 , pesticides were the ninth most common substance reported to poison control centers , and approximately 45 % of all reports of pesticide poisoning were for children . Organophosphate and carbamate poisoning are perhaps the most widely known acute poisoning syndromes , can be diagnosed by depressed red blood cell cholinesterase levels , and have available antidotal therapy . However , numerous other pesticides that may cause acute toxicity , such as pyrethroid and neonicotinoid insecticides , herbicides , fungicides , and rodenticides , also have specific toxic effects ; recognition of these effects may help identify acute exposures . Evidence is increasingly emerging about chronic health implication s from both acute and chronic exposure . A growing body of epidemiological evidence demonstrates associations between parental use of pesticides , particularly insecticides , with acute lymphocytic leukemia and brain tumors . Prenatal , household , and occupational exposures ( maternal and paternal ) appear to be the largest risks . Prospect i ve cohort studies link early-life exposure to organophosphates and organochlorine pesticides ( primarily DDT ) with adverse effects on neurodevelopment and behavior . Among the findings associated with increased pesticide levels are poorer mental development by using the Bayley index and increased scores on measures assessing pervasive developmental disorder , inattention , and attention-deficit/hyperactivity disorder . Related animal toxicology studies provide supportive biological plausibility for these findings . Additional data suggest that there may also be an association between parental pesticide use and adverse birth outcomes including physical birth defects , low birth weight , and fetal death , although the data are less robust than for cancer and neurodevelopmental effects . Children ’s exposures to pesticides should be limited as much as possible The take-home pathway is a significant source of organophosphate pesticide exposure for young children ( 3–5 years old ) living with an adult farmworker . This avoidable exposure pathway is an important target for intervention . We selected 24 agricultural communities in the Yakima Valley of Washington State and r and omly assigned them to receive an educational intervention ( n = 12 ) to reduce children ’s pesticide exposure or usual care ( n = 12 ) . We assessed exposure to pesticides in nearly 200 adults and children during the pre and post-intervention periods by measuring metabolites in urine . We compared pre- and post-intervention exposures by expressing the child ’s pesticide metabolite concentration as a fraction of the adult ’s concentration living in the same household , because the amount of pesticides applied during the collection periods varied . Exposures in our community were consistently higher , sometimes above the 95th percentile of the exposures reported by the National Health and Nutrition Examination Survey ( NHANES ) . While intervention and control communities demonstrated a reduction in the ratio of child to adult exposure , this reduction was more pronounced in intervention communities ( 2.7-fold , p < 0.001 compared to 1.7-fold , p = 0.052 for intervention and control , respectively ) . By examining the child/adult biomarker ratio , we demonstrated that our community-based intervention was effective in reducing pesticide exposure to children in agricultural communities We conducted a r and omized-controlled trial of a home-based intervention to reduce pesticide exposures to farmworkers ’ children in Monterey County , California ( n=116 families ) . The intervention consisted of three home-based educational sessions delivered by community health workers in Spanish . Measurements of organophosphate ( OP ) insecticide metabolites in child urine ( n=106 ) and pesticides in home floor wipes ( n=103 ) were collected before and after the intervention . Median child urinary dialkyl phosphate ( DAP ) metabolite levels were slightly lower among the intervention group children at follow-up compared with baseline , albeit nonsignificantly . DAP metabolite levels in the control group children were markedly higher at follow-up compared with baseline . In adjusted models , intervention participation was associated with a 51 % decrease in total DAP metabolite levels . Carbaryl , chlorpyrifos , cypermethrin , dacthal , diazinon , malathion , and trans-permethrin were commonly detected in the floor wipes . In adjusted models , intervention participation was significantly associated with a 37 % decrease in trans-permethrin floor wipe levels in homes , but not OP or other agricultural pesticides . In summary , intervention group children had slightly reduced pesticide exposures , whereas child exposures were higher among the control group . Additional intervention studies evaluating methods to reduce pesticide exposures to farmworker families and children are needed Background Exposure to organophosphate ( OP ) pesticides is an occupational hazard for farmworkers and affects their children through the take-home pathway . Objectives We examined the effectiveness of a r and omized community intervention to reduce pesticide exposure among farmworkers and their children . Methods We conducted a baseline survey of a cross-sectional sample of farmworkers ( year 1 ) in 24 participating communities . Communities were r and omized to intervention or control . After 2 years of intervention , a new cross-sectional survey of farmworkers was conducted ( year 4 ) . Farmworkers with a child 2–6 years of age were asked to participate in a sub study in which urine was collected from the farmworker and child , and dust was collected from the home and the vehicle driven to work . Results The median concentration of urinary metabolites was higher in year 4 than in year 1 for dimethylthiophosphate ( DMTP ) and dimethyldithiophosphate in adults and for DMTP for children . There were significant increases within both the intervention and control communities between year 1 and year 4 ( p < 0.005 ) ; however , the differences were not significant between study communities after adjusting for year ( p = 0.21 ) . The dust residue data showed azinphos-methyl having the highest percentage of detects in vehicles ( 86 % and 84 % in years 1 and 4 , respectively ) and in house dust ( 85 % and 83 % in years 1 and 4 , respectively ) . There were no significant differences between intervention and control communities after adjusting for year ( p = 0.49 ) . Conclusions We found no significant decreases in urinary pesticide metabolite concentrations or in pesticide residue concentrations in house and vehicle dust from intervention community households compared with control community households after adjusting for baseline . These negative findings may have implication s for future community-wide interventions
Output:
| RESULTS The majority of the review ed studies were conducted in the U.S. , but there seems to be an increase in literature on pesticide take-home pathway in developing countries .
Most of the articles provided evidence that farmworkers ' families are exposed to pesticides at higher levels than non-farmworkers ' families .
The levels may depend on several factors such as seasonality , parental occupation , cohabitation with a farmworker , behavior at work/home , age , and gender .
Community-based interventions disrupting the take-home pathway seem to be effective at reducing pesticide exposure . |
MS212219 | ***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 The community-based AERLI intervention provided training and education to people who inject drugs ( PWID ) about HIV and HCV transmission risk reduction , with a focus on drug injecting practice s , other injection-related complications , and access to HIV and HCV testing and care . We hypothesized that in such a population where HCV prevalence is very high and where few know their HCV serostatus , AERLI would lead to increased HCV testing . Methods The national multisite intervention study ANRS-AERLI consisted in assessing the impact of an injection-centered face-to-face educational session offered in volunteer harm reduction ( HR ) centers ( “ with intervention ” ) compared with st and ard HR centers ( “ without intervention ” ) . The study included 271 PWID interviewed on three occasions : enrolment , 6 and 12 months . Participants in the intervention group received at least one face-to-face educational session during the first 6 months . Measurements The primary outcome of this analysis was reporting to have been tested for HCV during the previous 6 months . Statistical analyses used a two-step Heckman approach to account for bias arising from the non-r and omized clustering design . This approach identified factors associated with HCV testing during the previous 6 months . Findings Of the 271 participants , 127 and 144 were enrolled in the control and intervention groups , respectively . Of the latter , 113 received at least one educational session . For the present analysis , we selected 114 and 88 participants eligible for HCV testing in the control and intervention groups , respectively . In the intervention group , 44 % of participants reported having being tested for HCV during the previous 6 months at enrolment and 85 % at 6 months or 12 months . In the control group , these percentages were 51 % at enrolment and 78 % at 12 months . Multivariable analyses showed that participants who received at least one educational session during follow-up were more likely to report HCV testing , compared with those who did not receive any intervention ( 95%[CI ] = 4.13[1.03;16.60 ] ) . Conclusion The educational intervention AERLI had already shown efficiency in reducing HCV at-risk practice s and associated cutaneous complications and also seems to have a positive impact in increasing HCV testing in PWID 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 Rising rates of infectious diseases in international migrants has reignited the debate around screening . There have been calls to strengthen primary -care-based programmes , focusing on latent TB . We did a cross-sectional study of new migrants to test an innovative one-stop blood test approach to detect multiple infections at one appointment ( HIV , latent tuberculosis , and hepatitis B/C ) on registration with a General Practitioner ( GP ) in primary care . Methods The study was done across two GP practice s attached to hospital Accident and Emergency Departments ( A&E ) in a high migrant area of London for 6 months . Inclusion criteria were foreign-born individuals from a high TB prevalence country ( > 40 cases per 100,000 ) who have lived in the UK ≤ 10 years , and were over 18 years of age . All new migrants who attended a New Patient Health Check were screened for eligibility and offered the blood test . We followed routine care pathways for follow-up . Results There were 1235 new registration s in 6 months . 453 attended their New Patient Health Check , of which 47 ( 10.4 % ) were identified as new migrants ( age 32.11 years [ range 18–72 ] ; 22 different nationalities ; time in UK 2.28 years [ 0–10 ] ) . 36 ( 76.6 % ) participated in the study . The intervention only increased the prevalence of diagnosed latent TB ( 18.18 % [ 95 % CI 6.98 - 35.46 ] ; 181.8 cases per 1000 ) . Ultimately 0 ( 0 % ) of 6 patients with latent TB went on to complete treatment ( 3 did not attend referral ) . No cases of HIV or hepatitis B/C were found . Foreign-born patients were under-represented at these practice s in relation to 2011 Census data ( Chi-square test −0.111 [ 95 % CI −0.125 to −0.097 ] ; p < 0.001 ) . Conclusion The one-stop approach was feasible in this context and acceptability was high . However , the number of presenting migrants was surprisingly low , reflecting the barriers to care that this group face on arrival , and none ultimately received treatment . The ongoing UK debate around immigration checks and charging in primary care for new migrants can only have negative implication s for the promotion of screening in this group . Until GP registration is more actively promoted in new migrants , a better place to test this one-stop approach could be in A&E departments where migrants may present in larger numbers Background : The prevalence of hepatitis C ( HCV ) is elevated within prison population s , yet diagnosis in prisons remains low . Dried blood spot testing ( DBST ) is a simple procedure for the detection of HCV antibodies ; its impact on testing in the prison context is unknown . Methods : We carried out a stepped-wedge cluster-r and omized control trial of DBST for HCV among prisoners within five male prisons and one female prison . Each prison was a separate cluster . The order in which the intervention ( training in use of DBST for HCV testing and logistic support ) was introduced was r and omized across clusters . The outcome measure was the HCV testing rate by prison . Imputation analysis was carried out to account for missing data . Planned and actual intervention times differed in some prisons ; data were thus analysed by intention to treat ( ITT ) and by observed step times . Results : There was insufficient evidence of an effect of the intervention on testing rate using either the ITT intervention time ( OR : 0.84 ; 95 % CI : 0.68–1.03 ; P = 0.088 ) or using the actual intervention time ( OR : 0.86 ; 95 % CI : 0.71–1.06 ; P = 0.153 ) . This was confirmed by the pooled results of five imputed data sets . Conclusions : DBST as a st and -alone intervention was insufficient to increase HCV diagnosis within the UK prison setting . Factors such as staff training and allocation of staff time for regular clinics are key to improving service delivery . We demonstrate that prisons can conduct rigorous studies of new interventions , but data collection can be problematic . Trial registration : International St and ard R and omized Controlled Trial Number Register ( IS RCT N number IS RCT N05628482 ) INTRODUCTION Because of its lack of clinical signs , the detection of hepatitis C virus ( HCV ) infection in the Netherl and s remains suboptimal . Therefore , the Dutch Health Council proposed an HCV campaign aim ed to inform the general public and motivate people at risk to seek medical advice . Because knowledge and awareness of HCV infection is low among primary care workers , the implementation of a support programme for primary care complementary to a HCV campaign seems appropriate . OBJECTIVE To evaluate the added value of a support programme for primary care complementary to a public HCV campaign . METHODS We performed a non-r and omized controlled intervention study . In two similar regions , a public HCV campaign was organized . In the intervention region , an additional support for primary care was provided by means of brochures , short courses and informative visits . RESULTS In the intervention region , the proportional increase in anti-HCV tests was 3.02 ( 57 - 172 tests ) . In the control region , this increase was 1.36 ( 86 - 118 tests ) . In the intervention region , the increase in positive anti-HCV tests was 1.7 % ( 95 % confidence interval ( CI ) : -0.2 % to -3.7 % ) . In the control region , this number decreased by 0.9 % ( 95 % CI : -4.1 % to 2.3 % ) . CONCLUSIONS The addition of primary care practice support leads to considerable improvements in medical consciousness regarding HCV infection in primary care . Even though the positive effect on case finding can not be indisputably demonstrated due to low prevalence , our results indicate such a positive effect . Therefore , future campaigns aim ed at hepatitis C should invariably implement additional support for primary care to improve diagnostic uptake and optimize case finding Objectives To assess the impact of computer-assisted interview compared with pen and paper on disclosure of sexual behaviour , diagnostic testing by clinicians , infections diagnosed and referral for counselling . Methods Two-centre parallel three-arm r and omised controlled open trial . Computer-generated r and omisation with allocation concealment using sealed envelopes . Setting Two London teaching hospital sexual health clinics . Participants 2351 clinic attenders over the age of 16 years . Interventions Computer-assisted self-interview ( CASI ) . Computer-assisted personal interview ( CAPI ) . Pen and paper interview ( PAPI ) . Main Outcome Measures Diagnostic tests ordered , sexually transmitted infections ( STI ) . Secondary Outcomes Disclosure of sexual risk , referral for counselling . Results 801 , 763 and 787 patients r and omly allocated to receive CASI , CAPI and PAPI . 795 , 744 and 779 were available for intention-to-treat analysis . Significantly more diagnostic testing for hepatitis B and C and rectal sample s in the CAPI arm ( odds for more testing relative to PAPI 1.32 ; 95 % CI 1.09 to 1.59 ) . This pattern was not seen among CASI patients . HIV testing was significantly lower among CASI patients ( odds for less testing relative to PAPI 0.73 ; 95 % CI 0.59 to 0.90 ) . STI diagnoses were not significantly different by trial arm . A summary measure of seven prespecified sensitive behaviours found greater reporting with CASI ( OR 1.4 ; 95 % CI 1.2 to 1.6 ) and CAPI ( OR 1.4 ; 95 % CI 1.2 to 1.7 ) compared with PAPI . Conclusion CASI and CAPI can generate greater recording of risky behaviour than traditional PAPI . Increased disclosure did not increase STI diagnoses . Safeguards may be needed to ensure that clinicians are prompted to act upon disclosures made during self-interview . Trial registration IS RCT N : 97674664 In this r and omized-control trial , conducted at a free clinic in France for predominately immigrant population s without healthcare , we demonstrate that simultaneous HIV/HBV/HCV point-of-care rapid testing improves screening outcomes . Increased awareness of infection status likely helped link these patients to care BACKGROUND Direct-acting antiviral therapy ( DAAs ) for hepatitis C infection ( HCV ) have a much smaller burden of treatment than interferon-based regimes , require less monitoring and are very effective . New pathways are required to increase access to treatment amongst people prescribed opioid substitution therapy ( OST ) . METHODS An exploratory cluster r and omised controlled trial with mixed methods evaluation was undertaken to compare the uptake of dried blood spot testing ( DBST ) and treatment of people with genotype 1 HCV infection in a conventional service pathway versus a pharmacist-led pathway in a population receiving OST . RESULTS Pharmacies r and omised to the conventional pathway obtained 58 DBST from 244 patients (24%):15 new reactive tests and 33 new negative tests were identified . Within the pharmacist-led pathway , 94 DBST were obtained from 262 patients ( 36 % ) : 26 new reactive tests and 54 new negative tests were identified . Participants in the pharmacist-led pathway were more likely to take a DBST ( p<0.003 ) . Of participants referred for treatment through the conventional pathway , 4 patients from 15 with new reactive tests ( 27 % ) attended clinic for assessment
Output:
| Testing targeted to population s at higher risk yielded high coverage rates in many setting s. Implementation of novel testing approaches , including dried blood spot ( DBS ) testing , was associated with increased coverage in several setting s including drug services , pharmacies and STI clinics .
Community‐based testing services were effective in reaching population s at higher risk for infection , vulnerable and hard‐to‐reach population s. In conclusion , our review identified several successful testing approaches implemented in healthcare and community setting s , including testing approaches targeting groups at higher risk , community‐based testing services and DBS testing .
Combining a diverse set of testing opportunities within national testing strategies may lead to higher impact both in terms of testing coverage and in terms of reduction , on the undiagnosed fraction |
MS212220 | ***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 Pakistan has high maternal mortality , particularly in the rural areas . The delay in decision making to seek medical care during obstetric emergencies remains a significant factor in maternal mortality . Methods We present results from an experimental study in rural Pakistan . Village clusters were r and omly assigned to intervention and control arms ( 16 clusters each ) . In the intervention clusters , women were provided information on safe motherhood through pictorial booklets and audiocassettes ; traditional birth attendants were trained in clean delivery and recognition of obstetric and newborn complications ; and emergency transportation systems were set up . In eight of the 16 intervention clusters , husb and s also received specially design ed education material s on safe motherhood and family planning . Pre- and post-intervention surveys on selected maternal and neonatal health indicators were conducted in all 32 clusters . A district-wide survey was conducted two years after project completion to measure any residual impact of the interventions . Results Pregnant women in intervention clusters received prenatal care and prophylactic iron therapy more frequently than pregnant women in control clusters . Providing safe motherhood education to husb and s result ed in further improvement of some indicators . There was a small but significant increase in percent of hospital deliveries but no impact on the use of skilled birth attendants . Perinatal mortality reduced significantly in clusters where only wives received information and education in safe motherhood . The survey to assess residual impact showed similar results . Conclusions We conclude that providing safe motherhood education increased the probability of pregnant women having prenatal care and utilization of health services for obstetric complications David Osrin and colleagues report findings from a cluster-r and omized trial conducted in Mumbai slums ; the trial aim ed to evaluate whether facilitator-supported women 's groups could improve perinatal outcomes Abstract Objectives : To establish the relative cost effectiveness of postnatal support in the community in addition to the usual care provided by community midwives . Design : R and omised controlled trial with six month follow up . Setting : Recruitment in a university teaching hospital and care provided in women 's homes . Participants : 623 postnatal women allocated at r and om to intervention ( 311 ) or control ( 312 ) group . Intervention : Up to 10 home visits in the first postnatal month of up to three hours duration by a community postnatal support worker . Main outcome measure : General health status as measured by the SF-36 and risk of postnatal depression . Breast feeding rates , satisfaction with care , use of services , and personal costs . Results : At six weeks there was no significant improvement in health status among the women in the intervention group . At six weeks the mean total NHS costs were £ 635 for the intervention group and £ 456 for the control group ( P=0.001 ) . At six months figures were £ 815 and £ 639 ( P=0.001 ) . There were no differences between the groups in use of social services or personal costs . The women in the intervention group were very satisfied with the support worker visits . Conclusions : There was no health benefit of additional home visits by community postnatal support workers compared with traditional community midwifery visiting as measured by the SF-36 . There were no savings to the NHS over six months after the introduction of the community postnatal support worker service Background Maternal and newborn mortality rates remain unacceptably high , especially where the majority of births occur in home setting s or in facilities with inadequate re sources . The introduction of emergency obstetric and newborn care services has been proposed by several organizations in order to improve pregnancy outcomes . However , the effectiveness of emergency obstetric and neonatal care services has never been proven . Also unproven is the effectiveness of community mobilization and community birth attendant training to improve pregnancy outcomes . Methods / Design We have developed a cluster-r and omized controlled trial to evaluate the impact of a comprehensive intervention of community mobilization , birth attendant training and improvement of quality of care in health facilities on perinatal mortality in low and middle-income countries where the majority of births take place in homes or first level care facilities . This trial will take place in 106 clusters ( 300 - 500 deliveries per year each ) across 7 sites of the Global Network for Women 's and Children 's Health Research in Argentina , Guatemala , India , Kenya , Pakistan and Zambia . The trial intervention has three key elements , community mobilization , home-based life saving skills for communities and birth attendants , and training of providers at obstetric facilities to improve quality of care . The primary outcome of the trial is perinatal mortality . Secondary outcomes include rates of stillbirth , 7-day neonatal mortality , maternal death or severe morbidity ( including obstetric fistula , eclampsia and obstetrical sepsis ) and 28-day neonatal mortality . Discussion In this trial , we are evaluating a combination of interventions including community mobilization and facility training in an attempt to improve pregnancy outcomes . If successful , the results of this trial will provide important information for policy makers and clinicians as they attempt to improve delivery services for pregnant women and newborns in low-income countries . Trial Registration Clinical Trials.gov Background A community-based r and omized control prenatal care trial was performed in a rural county of China during 2000 - 2003 . The purpose of this paper is to describe the trial implementation and the impact of the trial on the utilization of prenatal care and perinatal outcomes . Material s and methods In the study county , 10 townships ( from a total of 55 ) were each paired with a control ( 20 study townships in total ) , with the criteria for pairing being the township 's socioeconomic development , perinatal health , and maternal care utilization and provision . One of each township pair was r and omly allocated to the intervention or control groups . The trial interventions were : 1 ) training township hospital midwives and instructing them in how to provide systematic maternal care , 2 ) informing women in the community of the importance of prenatal care , 3 ) if needed , providing basic medical instruments to the hospitals . A variety of data sources were used to describe the trial implementation ( observations , group discussion s , field notes , survey to women ) . The data on pregnancy and perinatal outcomes were from the original h and -written work-records in the village family planning centers of the study townships . Results Implementation of the intervention was deficient . The factors hindering the trial implementation included poor coordination between midwives and family planning officers , broader policy changes implemented by the provincial government during the trial , the de central ization of county governance , and the lack of government funding for maternal care . There was only little difference in the use of maternal care , in women 's opinions related to maternal care or content of prenatal care , and no difference in the perinatal outcomes between the intervention and control townships . Conclusions A community based r and omized controlled trial could not be fully carried out in rural China as planned due to the changing political l and scape , the complexity of the socio-economic situation and a lengthy planning stage . The study could not answer if perinatal outcomes could be improved by increased use of prenatal care . Trial registration NCT Abstract Background Neonatal mortality remains high in rural Nepal . Previous work suggests that local women 's groups can effect significant improvement through community mobilisation . The possibility of identification and management of newborn infections by community-based workers has also arisen . Methods / Design The objective of this trial is to evaluate the effects on newborn health of two community-based interventions involving Female Community Health Volunteers . MIRA Dhanusha community groups : a participatory intervention with women 's groups . MIRA Dhanusha sepsis management : training of community volunteers in the recognition and management of neonatal sepsis . The study design is a cluster r and omized controlled trial involving 60 village development committee clusters allocated 1:1 to two interventions in a factorial design . MIRA Dhanusha community groups : Female Community Health Volunteers ( FCHVs ) are supported in convening monthly women 's groups . Nine groups per cluster ( 270 in total ) work through two action research cycles in which they ( i ) identify local issues around maternity , newborn health and nutrition , ( ii ) prioritise key problems , ( iii ) develop strategies to address them , ( iv ) implement the strategies , and ( v ) evaluate their success . Cycle 1 focuses on maternal and newborn health and cycle 2 on nutrition in pregnancy and infancy and associated postpartum care practice s. MIRA Dhanusha sepsis management : FCHVs are trained to care for vulnerable newborn infants . They ( i ) identify local births , ( ii ) identify low birth weight infants , ( iii ) identify possible newborn infection , ( iv ) manage the process of treatment with oral antibiotics and referral to a health facility to receive parenteral gentamicin , and ( v ) follow up infants and support families . Primary outcome : neonatal mortality rates . Secondary outcomes : MIRA Dhanusha community group : stillbirth , infant and under-two mortality rates , care practice s and health care seeking behaviour , maternal diet , breastfeeding and complementary feeding practice s , maternal and under-2 anthropometric status . MIRA Dhanusha sepsis management : identification and treatment of neonatal sepsis by community health volunteers , infection-specific neonatal mortality . Trial Registration noIS RCT N : IS RCT Background In Pakistan , only 59 - 73 % of children 12 - 23 months of age are fully immunized . This r and omized , controlled trial was conducted to assess the impact of a low-literacy immunization promotion educational intervention for mothers living in low-income communities of Karachi on infant immunization completion rates . Methods Three hundred and sixty-six mother-infant pairs , with infants aged ≤ 6 weeks , were enrolled and r and omized into either the intervention or control arm between August - November 2008 . The intervention , administered by trained community health workers , consisted of three targeted pictorial messages regarding vaccines . The control group received general health promotion messages based on Pakistan 's Lady Health Worker program curriculum . Assessment of DPT/Hepatitis B vaccine completion ( 3 doses ) was conducted 4-months after enrollment . A Poisson regression model was used to estimate effect of the intervention . The multivariable Poisson regression model included maternal education , paternal occupation , ownership of home , cooking fuel used at home , place of residence , the child 's immunization status at enrollment , and mother 's perception about the impact of immunization on child 's health . Results Baseline characteristics among the two groups were similar . At 4 month assessment , among 179 mother-infant pairs in the intervention group , 129 ( 72.1 % ) had received all 3 doses of DPT/Hepatitis B vaccine , whereas in the control group 92/178 ( 51.7 % ) had received all 3 doses . Multivariable analysis revealed a significant improvement of 39 % ( adjusted RR = 1.39 ; 95 % CI : 1.06 - 1.81 ) in DPT-3/Hepatitis B completion rates in the intervention group . Conclusion A simple educational intervention design ed for low-literate population s , improved DPT-3/Hepatitis B vaccine completion rates by 39 % . These findings have important implication s for improving routine immunization rates in Pakistan OBJECTIVES To determine the effectiveness of birth plans in increasing use of skilled care at delivery and in the postnatal period among antenatal care ( ANC ) attendees in a rural district with low occupancy of health units for delivery but high antenatal care uptake in northern Tanzania . METHODS Cluster r and omised trial in Ngorongoro district , Arusha region , involving 16 health units ( 8 per arm ) . Nine hundred and five pregnant women at 24 weeks of gestation and above ( 404 in the intervention arm ) were recruited and followed up to at least 1 month postpartum . RESULTS Skilled delivery care uptake was 16.8 % higher in the intervention units than in the control [ 95 % CI 2.6 - 31.0 ; P = 0.02 ] . Postnatal care utilisation in the first month of delivery was higher ( difference in proportions : 30.0 % [ 95 % CI 1.3 - 47.7 ; P < 0.01 ] ) and also initiated earlier ( mean duration 6.6 ± 1.7 days vs. 20.9 ± 4.4 days , P < 0.01 ) in the intervention than in the control arm . Women 's and providers ' reports of care satisfaction ( received or provided ) did not differ greatly between the two arms of the study ( difference in proportion : 12.1 % [ 95 % CI -6.3 - 30.5 ] P = 0.17 and 6.9 % [ 95 % CI -3.2 - 17.1 ] P = 0.15 , respectively ) . CONCLUSION Implementation of birth plans during ANC can increase the uptake of skilled delivery and post delivery care in the study district without negatively affecting women 's and providers ' satisfaction with available ANC services . Birth plans should be considered along with the range of other recommended interventions as a strategy to improve the uptake of maternal health services Background Around a quarter of the world 's neonatal and maternal deaths occur in India . Morbidity and mortality are highest in rural areas and among the poorest wealth quintiles . Few interventions to improve maternal and newborn health outcomes with government-m and ated community health workers have been rigorously evaluated at scale in this setting .The study aims to assess the impact of a community mobilisation intervention with women 's groups facilitated by ASHAs to improve maternal and newborn health outcomes among rural tribal communities of Jharkh and and Orissa . Methods / design The study is a cluster-r and omised controlled trial and will be implemented in five districts , three in Jharkh and and two in Orissa . The unit of r and omisation is a rural cluster of approximately 5000 population . We identified villages within rural , tribal areas of five districts , approached them for participation in the study and enrolled them into 30 clusters , with approximately 10 ASHAs per
Output:
| Our review offers encouraging evidence that community-based intervention packages reduce morbidity for women , mortality and morbidity for babies , and improves care-related outcomes particularly in low- and middle-income countries .
It has highlighted the value of integrating maternal and newborn care in community setting s through a range of interventions , which can be packaged effectively for delivery through a range of community health workers and health promotion groups .
While the importance of skilled delivery and facility-based services for maternal and newborn care can not be denied , there is sufficient evidence to scale up community-based care through packages which can be delivered by a range of community-based workers |
MS212221 | ***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 Keeping abdominal surgery patients warm is common and warming methods are needed in power outages during natural disasters . We aim ed to evaluate the efficacy of low-cost , low-power warming methods for maintaining normothermia in abdominal surgery patients . Methods Patients ( n = 160 ) scheduled for elective abdominal surgery were included in this prospect i ve clinical study . Five warming methods were applied : heated blood transfusion/fluid infusion vs. unheated ; wrapping patients vs. not wrapping ; applying moist dressings , heated or not ; surgical field rinse heated or not ; and applying heating blankets or not . Patients ’ nasopharyngeal and rectal temperatures were recorded to evaluate warming efficacy . Significant differences were found in mean temperatures of warmed patients compared to those not warmed . Results When we compared temperatures of abdominal surgery patient groups receiving three specific warming methods with temperatures of control groups not receiving these methods , significant differences were revealed in temperatures maintained during the surgeries between the warmed groups and controls . Discussion The value of maintaining normothermia in patients undergoing abdominal surgery under general anesthesia is accepted . Three effective economical and practically applicable warming methods are combined body wrapping and heating blanket ; combined body wrapping , heated moist dressings , and heating blanket ; combined body wrapping , heated moist dressings , and warmed surgical rinse fluid , with or without heating blanket . These methods are practically applicable when low-cost method is indeed needed BACKGROUND Mild perioperative hypothermia , which is common during major surgery , may promote surgical-wound infection by triggering thermoregulatory vasoconstriction , which decreases subcutaneous oxygen tension . Reduced levels of oxygen in tissue impair oxidative killing by neutrophils and decrease the strength of the healing wound by reducing the deposition of collagen . Hypothermia also directly impairs immune function . We tested the hypothesis that hypothermia both increases susceptibility to surgical-wound infection and lengthens hospitalization . METHODS Two hundred patients undergoing colorectal surgery were r and omly assigned to routine intraoperative thermal care ( the hypothermia group ) or additional warming ( the normothermia group ) . The patient 's anesthetic care was st and ardized , and they were all given cefam and ole and metronidazole . In a double-blind protocol , their wounds were evaluated daily until discharge from the hospital and in the clinic after two weeks ; wounds containing culture-positive pus were considered infected . The patients ' surgeons remained unaware of the patients ' group assignments . RESULTS The mean ( + /- SD ) final intraoperative core temperature was 34.7 + /- 0.6 degrees C in the hypothermia group and 36.6 + /- 0.5 degrees C in the normothermia group ( P < 0.001 ) Surgical-wound infections were found in 18 of 96 patients assigned to hypothermia ( 19 percent ) but in only 6 of 104 patients assigned to normothermia ( 6 percent , P = 0.009 ) . The sutures were removed one day later in the patients assigned to hypothermia than in those assigned to normothermia ( P = 0.002 ) , and the duration of hospitalization was prolonged by 2.6 days ( approximately 20 percent ) in hypothermia group ( P = 0.01 ) . CONCLUSIONS Hypothermia itself may delay healing and predispose patients to wound infections . Maintaining normothermia intraoperatively is likely to decrease the incidence of infectious complications in patients undergoing colorectal resection and to shorten their hospitalizations In this prospect i ve trial a study was made of the effect of warm irrigation on blood loss during transurethral prostatectomy ( TURP ) . A control group of 21 patients in whom irrigating fluid at operating room temperature ( mean 21.5 degrees C ) had been used was compared with a statistically comparable group of 19 patients in whom warm irrigating fluid ( mean 33.1 degrees C ) had been used . Blood loss in ml , in ml/g of tissue resected and in ml/min of resection time was not increased by the use of warm rather than room temperature irrigation . It was found that warm irrigation decreased heat loss and shivering in the patient during TURP and led to improved comfort both for patient and operator . The method of heating the irrigation bags was safe and economical Changes in mean body temperature and muscle protein metabolism were studied in elderly patients undergoing large bowel surgery . Two groups were studied : in one , efforts were made to maintain the patients normothermic during and after surgery by warming the fresh gases , the i.v . fluids , by placing warmed cotton padding around the exposed parts of the body and by covering the patients with a metallized plastic sheet in the recovery period . The other group received routine management . Otherwise the anaesthetic technique was comparable . The excretion of the amino acid 3-methylhistidine ( 3-MeH ) , an indicator of muscle protein breakdown , and urea nitrogen loss were measured in the urine collected the day before , and on the 2nd and 4th postoperative days . Prevention of heat loss during and after surgery caused a significant decrease in muscle protein degradation and nitrogen loss OBJECTIVE to verify the effectiveness of warmed intravenous infusion for hypothermia prevention in patients during the intraoperative period . METHOD experimental , comparative , field , prospect i ve and quantitative study undertaken at a federal public hospital . The sample was composed of 60 adults , included based on the criteria of axillary temperature between 36ºC and 37.1ºC and surgical abdominal access , divided into control and experimental groups , using the systematic probability sampling technique . RESULTS 22 patients ( 73.4 % ) from both groups left the operating room with hypothermia , that is , with temperatures below 36ºC ( p=1.0000 ) . The operating room temperature when patients arrived and patients ' temperature when they arrived at the operating room were statistically significant to affect the occurrence of hypothermia . CONCLUSION the planning and implementation of nursing interventions carried out by baccalaureate nurses are essential for preventing hypothermia and maintaining perioperative normothermia Mild intraoperative hypothermia is common . We therefore studied the effects of mild hypothermia on propofol pharmacokinetics , hepatic blood flow , and atracurium duration of action in healthy volunteers . Six young volunteers were studied on two r and omly assigned days , at either 34 degrees C or 37 degrees C. Anesthesia was induced with thiopental , 3 mg/kg , and maintained with 70 % N2 O and 0.6 % isoflurane . Core hypothermia was induced by conductive and convective cooling . On the other study day , normothermia was maintained by a Bair Hugger Registered Trademark ( Augustine Medical , Inc. , Eden Prairie , MN ) forced-air warmer . Propofol , 1 mg/kg lean body mass ( LBM ) , then was given , followed by a 4-h infusion at 5 mg centered dot kg-1 centered dot h-1 . After 2 h , atracurium 0.5 mg/kg was administered as an intravenous bolus . Indocyanine green was administered for estimation of hepatic blood flow . Arterial blood was assayed for propofol and indocyanine green concentration . Pharmacokinetic analysis was performed using NONMEM . Results are reported as means + /- SEM . Propofol blood concentrations averaged approximate equals 28 % more at 34 degrees C than at 37 degrees C ( P < 0.05 ) . Hepatic blood flow decreased 23 % + /- 11 % in normothermic volunteers during the propofol infusion , and 33 % + /- 11 % in hypothermic volunteers ( P = not significant ) . A three-compartment mamillary model fitted the data best . Inclusion of hepatic blood flow change from the prepropofol baseline as a covariate for total body clearance significantly improved the fit . The intercompartmental clearances were decreased in the presence of hypothermia . Core hypothermia prolonged the time to recovery of the first twitch in the train-of-four to 10 % of its control value ( T1 = 10 % ) after atracurium administration by approximate equals 60 % ( P < 0.05 ) , from 44 + /- 4 min to 68 + /- 7 min . In contrast , T1 = 25%-75 % remained unchanged . We conclude that 3 degrees C of core hypothermia increased propofol blood concentrations and prolonged atracurium duration of action . Hepatic blood flow was decreased during propofol administration , and this change was a significant predictor of propofol clearance , indicating that the effect of propofol on hepatic blood flow impairs the clearance of propofol itself . ( Anesth Analg 1995;80:1007 - 14 Twenty-four unpremedicated patients of ASA class II or III undergoing TURP were given esia with 10 mg of tetracaine at level L3 - 4 or L4 - 5 . These patients were r and omly given " warm " or " ambient temperature " irrigating fluids . Those with irrigating fluids of temperature between 25.5 degrees C and 33 degrees C were arranged as Group 1 and those of temperature between 21.5 and 23 degrees C as Group 2 . The results failed to show that the incidence of shivering could be decreased by the use of warm irrigating fluids Background Postoperative hypothermia and shivering is a frequent event in patients during cesarean section under spinal anesthesia . We assessed the effect of preoperative warming during cesarean delivery under spinal anesthesia for prevention of hypothermia and shivering . Methods Forty five patients undergoing elective cesarean section were r and omly assigned to three groups . Group F received warmed intravenous fluid ( 40 ℃ ) . Group A patients were actively warmed by forced air-warming . Group C was the control group . Forced air-warming and warmed fluid was maintained for the 15 min preceding spinal anesthesia . Core temperature ( tympanic membrane ) and the skin temperature of arm and thigh were measured and shivering was grade d simultaneously . Results The core temperature at 45 min decreased less in Groups F and A than Group C ( -0.5 ℃ ± 0.3 ℃ vs -0.6 ℃ ± 0.4 ℃ vs -0.9 ℃ ± 0.4 ℃ , respectively ; P = 0.004 ) . The arm temperature at 15 min and 30 min exhibited a greater increase in Group A than Group F and Group C ( P = 0.001 and P = 0.012 , respectively ) . Leg temperature increased similarly among the three groups . The incidence of shivering was significantly less in Group A and Group F than Group C ( 20 % , 13.3 % , and 53.3 % , respectively ; P = 0.035 ) . Conclusions Preoperative forced air-warming and warmed fluid prevents hypothermia and shivering in patients undergoing elective cesarean delivery with spinal anesthesia OBJECTIVES To investigate the effect using irrigation fluid at body temperature ( isothermic ) on patients ' ( core ) temperature during a transurethral resection of the prostate ( TURP ) and on the amount of peri-operative blood loss , the resection time and the subjective assessment of comfort by the patients . PATIENT AND METHODS In a r and omized study , patients undergoing TURP under spinal anaesthesia were divided into those receiving either isothermic irrigation fluid ( Group 1.28 patients ) or fluid at room temperature ( Group 2.31 patients ) . In Group 1 , a fluid heater maintained the irrigation fluid at body temperature until it reached the bladder . The body temperature of the patients was recorded rectally and orally during and after TURP and the peri-operative blood loss was also measured . The patients were interviewed on the first day after TURP to determine their assessment of comfort during the procedure . RESULTS The decrease in body temperature was 0.74 degree C in Group 1 and 1.71 degrees C in Group 2 , which was significantly different ( P < 0.001 ) . There was no significant difference in blood loss or resection-time . In Group 1 , only four ( 14 % ) of the patients were aware that their body was cooler , compared to 15 ( 50 % ) in Group 2 ( P = 0.038 ) . CONCLUSION Isothermic irrigation during TURP prevents excessive cooling and reduces the level of hypothermia . The reported increased mortality after TURP is probably related to peri-operative cardiac stress , an important factor which could be caused by the rapid decrease in body temperature which accompanies normal irrigation . Because the heating equipment presently available does not interfere with TURP , there are strong arguments for performing every TURP with irrigation fluid at body temperature Purpose To determine the relative efficacy of heat conservation and convective warming in maintaining penoperative normothermia . ( central temperature ≥36 ° C ) . Methods Thirty-seven patients undergoing elective gynaecological , orthopaedic , or general surgery scheduled to last two hours were prospect jvely studied . Patients were r and omized to one of two groups . Group I patients received heat conservation with reflective blankets ( Thermadrape ™ , Vital Signs , Inc. , Totowa , NJ ) applied preoperatively and warmed iv fluids ( Hotline ™ SIMS Level I Technologies , Inc , Rockl and , MA ) . Group 2 patients received convective warming ( BairHugger , Augustine Medical , Inc. , Eden Prairie , MN ) after induction of anaesthesia and iv flu
Output:
| Evidence was unclear regarding the effects of fluid warming on bleeding .
Warmed intravenous fluids also further reduced the risk of shivering compared with room temperature intravenous fluidsInvestigators reported no statistically significant differences in core body temperature or shivering between individuals given warmed and room temperature irrigation fluids .
AUTHORS ' CONCLUSIONS Warm intravenous fluids appear to keep patients warmer during surgery than room temperature fluids .
It is unclear whether the actual differences in temperature are clinical ly meaningful , or if other benefits or harms are associated with the use of warmed fluids .
It is also unclear if using fluid warming in addition to other warming methods confers any benefit , as a ceiling effect is likely when multiple methods of warming are used |
MS212222 | ***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 Asthma patients may experience acute episodic exacerbation . The guidelines recommend that written action plan should be given to asthma patients . However , no one can predict when and where acute exacerbation will happen . As people carry smart phone almost anytime and anywhere , smartphone application could be a useful tool in asthma care . We evaluated the feasibility of the ubiquitous healthcare system of asthma care using a smartphone application ( snuCare ) based on the self-management guideline or action plan . Methods Forty-four patients including fragile asthmatics were enrolled from Seoul National University Bundang Hospital between December 2011 and February 2012 . They were r and omly assigned into application user ( n = 22 ) or application nonuser group ( n = 22 ) . We evaluated user-satisfaction , and clinical parameters such as asthma control , Quality of Life Question naire for Adult Korean Asthmatics , and the adherence of patients . Results The characteristics were similar at baseline between the 2 groups except those who treated with short-term systemic steroid or increased dose of systemic steroid during previous 8 weeks ( user vs. nonuser : 31.8 % vs. 4.5 % , p = 0.020 ) . Total of 2,226 signals was generated during 8 weeks including 5 risky states . After eight weeks , the users answered that it was very easy to use the application , which was shown in highest scores in terms of satisfaction ( mean ± st and ard deviation , 4.3 ± 0.56 ) . Seventy-three percent of patients answered that the application was very useful for asthma care . User group showed improved the adherence scores ( p = 0.017 ) . One patient in application user group could avoid Emergency Department visit owing to the application while a patient in nonuser group visited Emergency Department . Conclusion The ubiquitous healthcare system using a smartphone application ( snuCare ) based on the self-management guideline or action plan could be helpful in the monitoring and the management of asthma Background : There is still debate over the benefit of self-management programmes for adults with asthma . A brief self-management programme given during a hospital admission for acute asthma was tested to determine whether it would reduce readmission . Method : A r and omised controlled trial was performed in 280 adult patients with acute asthma admitted over 29 months . Patients on the self-management programme ( SMP ) received 40–60 minutes of education supporting a written self-management plan . Control patients received st and ard care ( SC ) . Results : One month after discharge SMP patients were more likely than SC patients to report no daytime wheeze ( OR 2.6 , 95 % CI 1.5 to 5.3 ) , no night disturbance ( OR 2.0 , 95 % CI 1.2 to 3.5 ) , and no activity limitation ( OR 1.5 , 95 % CI 0.9 to 2.7 ) . Over 12 months 17 % of SMP patients were re-admitted compared with 27 % of SC patients ( OR 0.5 , 95 % CI 0.3 to 1.0 ) . Among first admission patients , OR readmission ( SMP v SC ) was 0.2 ( 95 % CI 0.1 to 0.7 ) , p<0.01 . For patients with a previous admission , OR readmission was 0.8 ( 95 % CI 0.4 to 1.6 ) , p=0.6 . SMP patients were more likely than SC patients to be prescribed inhaled steroids at discharge ( 99 % v 92 % , p=0.03 ) , oral steroids ( 98 % v 90 % , p=0.06 ) , and to have hospital follow up ( 98 % v 84 % , p<0.01 ) but adjustment for these differences did not diminish the effect of the self-management programme . Conclusions : A brief self-management programme during hospital admission reduced post discharge morbidity and readmission for adult asthma patients . The benefit of the programme may have been greater for patients admitted for the first time . The programme also had a small but significant effect on medical management at discharge BACKGROUND The " credit card " asthma self-management plan provides the adult asthmatic patient with simple guidelines for the self-management of asthma , which are based on the self- assessment of peak expiratory flow rate recordings and symptoms . OBJECTIVE The study was a trial of the clinical efficacy of the credit card plan in a high-risk group of asthmatic patients . METHODS In this " before- and -after " trial , patients discharged from the emergency department of Wellington Hospital , after treatment for severe asthma were invited to attend a series of hospital outpatient clinics at which the credit card plan was introduced . Question naires were used to compare markers of asthma morbidity , requirement for emergency medical care , and medication use during the 6-month period before and after intervention with the credit card plan . RESULTS Of the 30 patients with asthma who attended the first outpatient clinic , 26 ( 17 women and 9 men ) completed the program . In these 26 participants , there was a reduction in both morbidity and requirement for acute medical services : specifically , the proportion waking with asthma more than once a week decreased from 65 % to 23 % ( p = 0.005 ) and the proportion visiting the emergency department for treatment of severe asthma decreased from 58 % to 15 % ( p = 0.004 ) . The patients attending the clinics commented favorably on the plan , in particular on its usefulness as an educational tool for monitoring and treating their asthma . CONCLUSIONS Although the interpretation of this study is limited by the lack of a r and omized control group , the findings are consistent with other evidence that the credit card asthma self-management plan can be an effective and acceptable system for improving asthma care in a high-risk group of adult patients with asthma Background : In clinical trials of asthma , the outcomes are often good , but when the same treatment regimens are implemented in primary care , equally good results are not obtained . Objective : To investigate if addition of structured patient information and monitoring by an asthma diary in primary care improves asthma control . Methods : 141 patients from 19 primary care centres were studied . The centres were r and omised to a st and ard care group or to an intervention group . The intervention group received structured written and oral information about asthma and asthma medication , and were instructed to keep an asthma diary . The primary outcome was asthma control as assessed by the Asthma Control Question naire . Secondary outcomes were costs of asthma medication , the Mini Asthma Quality of Life Question naire score and lung function . Results : Asthma Control Question naire score changes differed between the study groups ( p < 0.05 ) . In the intervention group , these changes ( M = –0.45 ) in asthma control were close to clinical significance ( minimal important difference ≈0.5 ) . Both groups improved in disease-specific quality of life scores . For the intervention group , which changed the most ( p < 0.05 ) , the change exceeded the threshold for the minimal important difference ( 0.5 ) . The costs of medications increased significantly in the intervention group , where adjustments of medication were made more often than in controls . Conclusion : Disease-specific quality of life of asthma patients could be improved by adding structured information and monitoring by diary to st and ard care The effects on self management of asthma of a specially prepared book and audiocassette tape with similar contents were observed in a controlled study of 177 patients with asthma in general practice . After a run in period of six months patients were r and omly given the book , the tape , both the book and tape , or neither . Patients ' knowledge of the use of drugs , perceptions of their disability , skill in using an inhaler , consumption of drugs , consultations with their general practitioners , morbidity ( from patients ' entries on diary cards ) , and use of the educational material were measured . Knowledge about the use of drugs was significantly increased in the groups who received the material after three months and persisted after 12 months . Patients who had been given the tape or the book and tape increased their scores of knowledge of drugs more than patients given the book alone . Patients in all groups given the material considered that their disability was reduced . There were no other significant changes . Patients given both the book and the tape preferred the book . Patients with asthma can obtain useful information from such material . The paradoxical result whereby patients learnt more from the tape but preferred the book suggests that a distinction can be made between information that patients need , which may be acquired better from an audiocassette , and information that they want , which may be acquired better from a book OBJECTIVES To improve the asthma control and adherence to asthma preventer medication of older people using the Patient Asthma Concerns Tool ( PACT ) to identify and address unmet needs and patient concerns . METHODS Community dwelling adults over 55 years , living in Victoria or New South Wales were recruited into a single-blind , parallel design , r and omised-controlled trial comparing person-centred education including device technique , versus written information-only education . Fifty-eight participants r and omised to the intervention group and 56 to the control completed participation . OUTCOME MEASURES asthma control , adherence to preventer medication , asthma related quality of life , asthma exacerbations and written action plan ownership were assessed at baseline , and 3 and 12 months post intervention . RESULTS Intervention participants experienced improvements in asthma control , adherence to asthma preventer medication , reduced exacerbations , improved quality of life and an increase in asthma action plan ownership at 3 and 12 months . CONCLUSION Asthma outcomes in older people can be significantly improved by delivering tailored education that identifies specific patient concerns and unmet needs . PRACTICAL IMPLICATION S Use of the PACT to identify patient concerns and unmet needs will assist health professionals to improve the health literacy of patients by addressing gaps in their knowledge and perceptions of asthma control Background Many studies have shown the effectiveness of self-management for patients with asthma . In particular , possession and use of a written asthma action plan provided by a doctor has shown to significantly improve patients ’ asthma control . Yet , uptake of a written asthma action plan and preventative asthma management is low in the community , especially amongst adults . Objective A Web-based personally controlled health management system ( PCHMS ) called Healthy.me will be evaluated in a 2010 CONSORT-compliant 2-group ( static websites verse PCHMS ) parallel r and omized controlled trial ( RCT ) ( allocation ratio 1:1 ) . Methods The PCHMS integrates an untethered personal health record with consumer care pathways and social forums . After eligibility assessment , a sample of 300 adult patients with moderate persistent asthma will be r and omly assigned to one of these arms . After 12 months of using either Healthy.me or information websites ( usual care arm ) , a post- study assessment will be conducted . Results The primary outcome measure is possession of or revision of an asthma action plan during the study . Secondary outcome measures include : ( 1 ) adherence to the asthma action plan , ( 2 ) rate of planned and unplanned visits to healthcare providers for asthma issues , ( 3 ) usage patterns of Healthy.me and attrition rates , ( 4 ) asthma control and asthma exacerbation scores , and ( 5 ) impact of asthma on life and competing dem and s , and days lost from work . Conclusions This RCT will provide insights into whether access to an online PCHMS will improve uptake of a written asthma action plan and preventative asthma actions . Trial Registration Trial Registration : Australian New Zeal and Clinical Trials Registry ACTRN12612000716864 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=362714 ( Archived by WebCite at http://www.webcitation.org/6IYBJGRnW ) A prospect i ve controlled trial of home monitoring of peak expiratory flow rate ( PEFR ) was conducted to determine the usefulness of an objective measure of lung function in association with an education program and a medication self-management plan in reducing morbidity in adult patients with asthma . Thirty-five patients managed themselves , using peak flow readings as the basis for the therapeutic plan coupled with educational intervention , whereas 35 control patients used symptoms and spirometric data for following physicians ' treatment plans . After a 6-mo study period , patients in the experimental group showed statistically significant improvements in morbidity parameters ( days lost from work , acute asthma attacks , days on antibiotic therapy , physician consultations , and emergency room admissions for asthma ) , increases in FVC , FEV1 , and FEV1/FVC , mean PEFR and mean morning PEFR , decrease in percentage of the mean PEFR amplitude , and a reduction in the use of inhaled beta-agonists , oral theophylline , and oral prednisone . Although improvements in some of these parameters were also found in the control group , they did not reach the levels of significance obtained in the experimental group . The personal use of an objective measure of lung function in association with a medication self-management plan leads to improvement in the patient 's condition OBJECTIVES Despite advances in recent years , asthma morbidity and mortality have been noted to be on the increase in the past decade . The present study examined the failures and recommendations of past studies and introduced a new milieu for asthma care -- the community pharmacy . The study incorporated a care protocol with the important ingredients of asthma education on medications , triggers , self-monitoring and an asthma plan , with pharmacists taking responsibility for outcomes , assessment of a patient 's readiness to change and tailoring education to that readiness , compliance monitoring and physician consultation to achieve asthma prescribing guidelines . METHODS Thirty-three pharmacists in British Columbia , specially trained and certified in asthma care , agreed to participate in a study in which experienced
Output:
| AUTHORS ' CONCLUSIONS Analysis of available studies was limited by variable reporting of primary and secondary outcomes ; therefore , it is difficult to draw firm conclusions related to the effectiveness of PAAPs in the management of adult asthma .
In the context of this caveat , we found no observable effect on the primary outcomes of hospital attendance with an asthma exacerbation , asthma symptom scores or adverse events . |
MS212223 | ***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: Hypersensitivity to a variety of sensory stimuli is a feature of persistent whiplash associated disorders ( WAD ) . However , little is known about sensory disturbances from the time of injury until transition to either recovery or symptom persistence . Quantitative sensory testing ( pressure and thermal pain thresholds , the brachial plexus provocation test ) , the sympathetic vasoconstrictor reflex and psychological distress ( GHQ‐28 ) were prospect ively measured in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . Sensory and sympathetic nervous system tests were also measured in 20 control subjects . All whiplash groups demonstrated local mechanical hyperalgesia in the cervical spine at 1 month post‐injury . This hyperalgesia persisted in those with moderate/severe symptoms at 6 months but resolved by 2 months in those who had recovered or reported persistent mild symptoms . Only those with persistent moderate/severe symptoms at 6 months demonstrated generalised hypersensitivity to all sensory tests . These changes occurred within 1 month of injury and remained unchanged throughout the study period . Whilst no significant group differences were evident for the sympathetic vasoconstrictor response , the moderate/severe group showed a tendency for diminished sympathetic reactivity . GHQ‐28 scores of the moderate/severe group were higher than those of the other two groups . The differences in GHQ‐28 did not impact on any of the sensory measures . These findings suggest that those with persistent moderate/severe symptoms at 6 months display , soon after injury , generalised hypersensitivity suggestive of changes in central pain processing mechanisms . This phenomenon did not occur in those who recover or those with persistent mild symptoms A novel therapy for rheumatoid arthritis , regional sympathetic blockade using guanethidine , was investigated in 24 patients with active disease . In a r and omized double blind short-term ( 14 days ) study , we evaluated the effect of therapy on subjective responses , change in pain , stiffness , and morning stiffness and no objective responses , change in pinch strength , grip strength , and joint tenderness . Compared to placebo , guanethidine produced a decrease in pain ( p less than 0.025 ) and an increase in pinch strength ( less than 0.025 ) over the 2-week duration of the study . The therapeutic effect of guanethidine may be mediated by an interruption of the proinflammatory effects of the sympathetic nervous system OBJECTIVE An earlier pilot study suggested that the late whiplash syndrome is uncommon in Greece . The purpose of the present study is to extend the evaluation to a larger sample , and include the prevalence of specific symptoms in the evaluation . METHODS In a prospect i ve , cohort study , a total of 180 accident victims were consecutively recruited following Emergency ward presentation . A st and ard question naire asked about neck pain , headache , shoulder pain , limb numbness or pain , and dizziness . Accident victims were followed for 6 months . RESULTS In the initial 4 weeks after the accident , accident victims reported neck pain , headache , shoulder pain , arm numbness or pain , and dizziness , but at 4 weeks more than 90 % had recovered from these , the remainder of the subjects having minor symptoms ( not requiring therapy ) , and returning to their pre-accident state of health ( which included minor symptoms ) . There were no cases of chronic disability . CONCLUSION In Greece , symptoms after an acute whiplash injury are self-limiting , brief , and do not appear to evolve into the so-called late whiplash syndrome Objectives To determine if genetic variation in genes in the hypothalamic – pituitary – adrenal ( HPA ) axis , the primary stress response system , influences susceptibility to developing musculoskeletal pain . Methods Pain and comorbidity data was collected at three time points in a prospect i ve population -based cohort study . Pairwise tagging single nucleotide polymorphisms ( SNPs ) were selected and genotyped for seven genes . Genetic association analysis was carried out using zero-inflated negative binomial regression to test for association between SNPs and the maximum number of pain sites across the three time points in participants reporting pain , reported as proportional changes with 95 % CIs . SNPs were also tested for association with chronic widespread pain ( CWP ) using logistic regression reporting odds ratios and 95 % CI . Results A total of 75 SNPs were successfully genotyped in 994 participants including 164 cases with persistent CWP and 172 pain-free controls . Multiple SNPs in SERPINA6 were associated with the maximum number of pain sites ; for example , each copy of the T allele of rs941601 was associated with having 16 % ( proportional change=1.16 , 95 % CI 1.04 to 1.28 , p=0.006 ) more pain sites compared to participants with the CC genotype . SERPINA6 gene SNPs were also associated with CWP . Significant associations between the maximum number of pain sites and SNPs in the CRHBP and POMC genes were also observed and a SNP in MC2R was also associated with CWP . Associations between SNPs and comorbidity of poor sleep quality and depression explained some of the associations observed . Conclusions Genetic variation in HPA axis genes was associated with musculoskeletal pain ; however , some of the associations were explained by comorbidities . Replication of these findings is required in independent cohorts & NA ; Patients with postoperative ongoing sciatic pain have been shown to exhibit reduced cortisol levels along with enhanced IL‐6 levels . The aim of the present study was to clarify the relationship between a reduced cortisol secretion and enhanced cytokine levels by performing a prospect i ve study on patients with disc herniation . Twenty‐two patients were examined before and after their disc surgery . Twelve healthy , pain‐free subjects matched for age , education and gender constituted the control group . The preoperative examinations included the assessment of the diurnal pattern of cortisol secretion and the feedback sensitivity of the hypothalamus – pituitary – adrenal ( HPA ) axis . Patients ' subjective stress levels also were assessed during the preoperative examination . The diurnal pattern of cortisol secretion was again assessed during the postoperative examination . Furthermore , blood sample s were collected to measure catecholamine , adrenocorticotropic hormone (ACTH)‐ and interleukin‐6 ( IL‐6 ) levels before and after measuring the pressure pain thresholds ( PPTs ) . An assessment of the sensitivity of circulating monocytes to the immunosuppressive effects of glucocorticoids was further included in the postoperative examinations . Failed back syndrome ( FBS ) patients ( n=12 ) showed a reduced cortisol secretion in the morning hours and enhanced feedback sensitivity of the HPA axis . Furthermore , FBS patients displayed an increased in‐vitro production of proinflammatory cytokines and a relative glucocorticoid resistance of pro‐inflammatory cytokine producing monocytes as compared to non‐FBS patients ( n=10 ) and controls . After PPT measurement FBS patients exhibited an increased norepinephrine but decreased epinephrine response , together with lower ACTH levels and a four times higher plasma IL‐6 response . These findings suggest that chronically stressed patients are at a higher risk for a poor surgical outcome as their reduced cortisol secretion promotes the postoperative ongoing synthesis of proinflammatory cytokines Study Design . An experimental study of motor and sensory function and psychological distress in subjects with acute whiplash injury . Objectives . To characterize acute whiplash injury in terms of motor and sensory systems dysfunction and psychological distress and to compare subjects with higher and lesser levels of pain and disability . Summary of Background Data . Motor system dysfunction , sensory hypersensitivity , and psychological distress are present in chronic whiplash associated disorders ( WAD ) , but little is known of such factors in the acute stage of injury . As higher levels of pain and disability in acute WAD are accepted as signs of poor outcome , further characterization of this group from those with lesser symptoms is important . Material s and Methods . Motor function ( cervical range of movement [ ROM ] , joint position error [ JPE ] ; activity of the superficial neck flexors [ EMG ] during a test of cranio-cervical flexion ) , quantitative sensory testing ( pressure , thermal pain thresholds , and responses to the brachial plexus provocation test ) , and psychological distress ( GHQ-28 , TAMPA , IES ) were measured in 80 whiplash subjects ( WAD II or III ) within 1 month of injury , as were 20 control subjects . Results . Three subgroups were identified in the cohort using cluster analysis based on the Neck Disability Index : those with mild , moderate , or severe pain and disability . All whiplash groups demonstrated decreased ROM and increased EMG compared with the controls ( all P < 0.01 ) . Only the moderate and severe groups demonstrated greater JPE and generalized hypersensitivity to all sensory tests ( all P < 0.01 ) . The three whiplash subgroups demonstrated evidence of psychological distress , although this was greater in the moderate and severe groups . Measures of psychological distress did not impact on between group differences in motor or sensory tests . Conclusions . Acute whiplash subjects with higher levels of pain and disability were distinguished by sensory hypersensitivity to a variety of stimuli , suggestive of central nervous system sensitization occurring soon after injury . These responses occurred independently of psychological distress . These findings may be important for the differential diagnosis of acute whiplash injury and could be one reason why those with higher initial pain and disability demonstrate a poorer outcome BACKGROUND Perioperative myocardial ischemia is the single most important potentially reversible risk factor for mortality and cardiovascular complications after noncardiac surgery . Although more than 1 million patients have such complications annually , there is no effective preventive therapy . METHODS We performed a r and omized , double-blind , placebo-controlled trial to compare the effect of atenolol with that of a placebo on overall survival and cardiovascular morbidity in patients with or at risk for coronary artery disease who were undergoing noncardiac surgery . Atenolol was given intravenously before and immediately after surgery and orally thereafter for the duration of hospitalization . Patients were followed over the subsequent two years . RESULTS A total of 200 patients were enrolled . Ninety-nine were assigned to the atenolol group , and 101 to the placebo group . One hundred ninety-four patients survived to be discharged from the hospital , and 192 of these were followed for two years . Overall mortality after discharge from the hospital was significantly lower among the atenolol-treated patients than among those who were given placebo over the six months following hospital discharge ( 0 vs. 8 percent , P<0.001 ) , over the first year ( 3 percent vs. 14 percent , P=0.005 ) , and over two years ( 10 percent vs. 21 percent , P=0.019 ) . The principal effect was a reduction in deaths from cardiac causes during the first six to eight months . Combined cardiovascular outcomes were similarly reduced among the atenolol-treated patients ; event-free survival throughout the two-year study period was 68 percent in the placebo group and 83 percent in the atenolol group ( P=0.008 ) . CONCLUSIONS In patients who have or are at risk for coronary artery disease who must undergo noncardiac surgery , treatment with atenolol during hospitalization can reduce mortality and the incidence of cardiovascular complications for as long as two years after surgery OBJECTIVE Abnormalities of the biological stress response ( hypothalamic-pituitary-adrenal axis and the autonomic nervous system ) have been identified in both fibromyalgia ( FM ) and chronic fatigue syndrome ( CFS ) . Although these changes have been considered to be partly responsible for symptom expression , we examine an alternative hypothesis that these HPA and autonomic changes can be found in subsets of healthy individuals in the general population who may be at risk of developing these conditions . Exposure to " stressors " ( e.g. , infections , trauma , etc . ) may lead to symptom expression ( pain , fatigue , and other somatic symptoms ) in part by precipitating lifestyle changes . In particular , we focus on the effect of deprivation of routine aerobic exercise on the development of somatic symptoms . METHODS Eighteen regularly exercising ( > /=4 h/week ) asymptomatic , healthy adults refrained from physical activity for 1 week . We predicted that a subset of these individuals would develop symptoms of FM/CFS with exercise deprivation , and this manuscript focuses on the baseline HPA axis , immune , and autonomic function measures that may predict the development of symptoms . RESULTS Eight of the subjects reported a 10 % increase in one or more symptoms ( pain , fatigue , mood ) after 1 week of exercise deprivation . These symptomatic subjects had lower HPA axis ( baseline cortisol prior to VO2max testing ) , immune ( NK cell responsiveness to venipuncture ) , and autonomic function ( measured by heart rate variability ) at baseline ( prior to cessation of exercise ) when compared to the subjects who did not develop symptoms . CONCLUSIONS A subset of subjects developed symptoms of pain , fatigue , or mood changes after exercise deprivation . This cohort was different from the individuals who did not develop symptoms in baseline measures of HPA axis , immune , and autonomic function . We speculate that a subset of healthy individuals who have hypoactive function of the biological stress response systems unknowingly exercise regularly to augment the function of these systems and thus suppress symptoms
Output:
| Such pain vulnerability because of stress system function may interact with the effects of biomechanical injury and psychobehavioral responses to influence the development of WAD . |
MS212224 | ***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: Breastfeeding rates among low-income women in the east-south- central United States are among the lowest in the country . This study examined the effect of a peer counseling program on breastfeeding initiation and duration in a low-income rural population in West Tennessee . A postpartum survey and chart review were conducted with WIC clients at nine health departments . Response rate was 99 % ( 291/293 ) . Breastfeeding initiation and duration at 6 weeks were increased in the peer counselor group ( n= 156 ) compared with women in the no-peer counselor group ( n= 135 ) ( 53 % vs. 33%,p<0.001 , and 26 % vs. 13%,p=0.006 , respectively ) . Multivariate analysis revealed that women in the peer counselor group were significantly more likely to initiate breastfeeding ( OR=2.43 , 95 % CI=1.23 - 4.67 ) and to be breastfeeding at 6 weeks ( OR=2.78 , 95 % CI=2.08 - 9.5 1 ) , than those in the no-peer counselor group We evaluated the single and combined effects of introducing a motivational video and peer counseling into four matched WIC clinics on breastfeeding initiation and continuation at 7 - 10 days among African-American WIC participants . Of the 242 women with complete data , 48 % initiated breastfeeding , but only 31 % were still breastfeeding at 7 - 10 days . Initiation was associated with cesarean delivery , infant feeding instruction , no artificial milk discharge pack , attending the peer counselor only-intervention site , and intention to breastfeed . Continuation was influenced by infant feeding instruction , no artificial milk discharge pack , and intention to breastfeed . Overall , trends toward a positive impact of the breastfeeding promotion activities were evident but weak , and largely gone by 7 - 10 days postpartum Objective : To evaluate the effectiveness of a lay delivered intervention to reduce Latino children ’s exposure to environmental tobacco smoke ( ETS ) . The a priori hypothesis was that children living in households that were in the intervention group would have lower exposure over time than measurement only controls . Design : A two group , r and omised control trial was conducted . Setting : Areas of San Diego county with a large Latino population . Participants : 143 Latino parent – child pairs . Intervention : Trained bicultural and bilingual Latina lay community health advisors , or promotoras , conducted problem solving aim ed at lowering the target child ’s exposure to ETS in the household . Six home and telephone sessions were delivered by the promotoras over a four month period . Main outcome measures : Outcome measures were collected at baseline , immediately post-intervention , three months post-intervention , and 12 months post-intervention . Four outcomes were considered : ( 1 ) parent ’s paper- and -pencil reports of the child ’s past month exposure ; ( 2 ) hair sample s from the child analysed for past month nicotine ; ( 3 ) hair sample s from the child analysed for past month cotinine ; and ( 4 ) per cent confirmed reducers . Results : There were no significant condition-by-time interactions , the term indicative of a differential intervention effect . Significant or near significant time main effects were seen for children ’s hair cotinine , per cent confirmed reducers , and , in particular , parent reports of exposure . Conclusions : Applying a lay promotora model to deliver the behavioural problem solving intervention unfortunately was not effective . A likely explanation relates to the difficulty of delivering a relatively complex intervention by lay women untrained in behaviour change theory and research methods OBJECTIVE To assess the effectiveness of a volunteer-driven outreach program on immunization rates in children younger than 2 years . DESIGN R and omized controlled trial . SETTING Pediatric ambulatory clinics in New York , NY . PATIENTS A total of 163 children were r and omly assigned to receive services from the volunteer-driven outreach program or to serve as control subjects . All children were ( 1 ) younger than 2 years , ( 2 ) no-shows for a scheduled appointment in the pediatric clinic , and ( 3 ) due or overdue for a vaccine . INTERVENTION Immunization outreach , tracking , and follow-up were provided by community volunteers throughout follow-up ( mean , 6.5 months ) . Control children were notified of immunization status at enrollment but received no further contact until the conclusion of follow-up ( mean , 6.4 months ) . MAIN OUTCOME MEASURE Immunization status 6 months after enrollment . RESULTS Significantly more intervention children were up-to- date with their vaccination series than controls ( 75 % vs. 54 % ; P = .03 ) . Children in the control group were 2.8 times more likely to be late for a vaccine than intervention children ( odds ratio = 2.8 ; P = .02 ) . In addition , an immunization delay of longer than 30 days at enrollment was a significant predictor of final immunization delay ( odds ratio = 2.6 ; P = .02 ) . CONCLUSIONS This volunteer-driven program significantly improved immunization rates among intervention children compared with controls . Results confirm previous findings that indicate an increased risk of an incomplete immunization series by 2 years of age among children who fall behind early in their primary vaccination series . However , control children were almost 3 times more likely to be late ( for > or = 1 vaccines ) than intervention children , regardless of whether an earlier immunization delay was present BACKGROUND The purpose of this demonstration project was to test the effectiveness of a volunteer peer counseling program for promoting breastfeeding in a community . METHODS The two-year project was conducted in Iowa from September 1994 to September 1996 . Both intervention and control groups were rural low-income pregnant and postpartum women who qualified for the Women , Infants and Children 's ( WIC ) nutritional program . The intervention was initiated in two counties with 143 clients , of whom 72 completed the project . The control group was drawn from six counties that had received no significant breastfeeding promotion programs during the previous three years . The intervention was the assignment of trained volunteers with previous successful personal experience with breastfeeding as peer counselors to low-income pregnant women . Both before and after the baby was born , the volunteers taught a series of in-home , one-to-one lessons about healthy diet and breastfeeding , and maintained informal contact to answer questions or help with concerns . RESULTS Women in the intervention group improved dietary intake when compared with the control group . Knowledge of breastfeeding and good nutrition improved slightly . Eighty-two percent of intervention compared with 31 percent of control group women initiated breastfeeding . Mean duration of breastfeeding for intervention and control group women was 5.7 and 2.5 weeks , respectively . At 4 weeks , 56 percent of intervention and 10 percent of control group women were still breastfeeding . CONCLUSION A volunteer peer counseling program that provides low-income women with role models , accurate information , support , and encouragement can increase the duration of breastfeeding , and thus contribute to healthier infants BACKGROUND Breastfeeding can ameliorate some of the complex health issues faced by low-income families . Women who breastfeed and their infants have lower health care costs compared with those who formula feed . Increasing the duration of breastfeeding is recognized as a national priority , particularly for low-income women . This community-based r and omized clinical trial involving low-income mothers compared usual care with an intervention comprising hospital and home visits , and telephone support by a community health nurse/peer counselor team for 6 months after delivery . METHODS Forty-one women were recruited after delivery of a full-term singleton infant and r and omly assigned to intervention or usual care groups . RESULTS Women receiving the community health intervention breastfed longer than the women receiving usual care . The infants in the intervention group had fewer sick visits and reported use of fewer medications than infants in the usual care group . The intervention cost ( $ 301/mother ) was partially offset by cost savings on formula and health care . CONCLUSIONS Community health nurse and peer counselor support can increase breastfeeding duration in low-income women , and has the potential to reduce total costs including the cost of support OBJECTIVE To assess the efficacy of peer counseling to promote exclusive breastfeeding ( EBF ) among low-income inner-city women in Hartford , Conn. DESIGN Participants recruited prenatally were r and omly assigned to either receive support for EBF from a peer counselor plus conventional breastfeeding support ( peer counseling group [ PC ] ) or only conventional breastfeeding support ( control group [ CG ] ) and followed through 3 months post partum . SETTING Low-income predominantly Latina community . PARTICIPANTS Expectant mothers , less than 32 weeks gestation and considering breastfeeding ( N = 162 ) . Intervention Exclusive breastfeeding peer counseling support offering 3 prenatal home visits , daily perinatal visits , 9 postpartum home visits , and telephone counseling as needed . MAIN OUTCOME MEASURES Exclusive breastfeeding rates at hospital discharge , 1 , 2 , and 3 months post partum ( n = 135 ) . RESULTS At hospital discharge , 24 % in the CG compared with 9 % in the PC had not initiated breastfeeding , with 56 % and 41 % , respectively , nonexclusively breastfeeding . At 3 months , 97 % in the CG and 73 % in the PC had not exclusively breastfed ( relative risk [ RR ] = 1.33 ; 95 % CI , 1.14 - 1.56 ) during the previous 24 hours . The likelihood of nonexclusive breastfeeding throughout the first 3 months was significantly higher for the CG than the PC ( 99 % vs 79 % ; RR = 1.24 ; 95 % CI , 1.09 - 1.41 ) . Mothers in the CG were less likely than their PC counterparts to remain amenorrheic at 3 months ( 33 % vs 52 % ; RR = 0.64 ; 95 % CI , 0.43 - 0.95 ) . The likelihood of having 1 or more diarrheal episode in infants was cut in half in the PC ( 18 % vs 38 % ; RR = 2.15 ; 95 % CI , 1.16 - 3.97 ) . CONCLUSION Well-structured , intensive breastfeeding support provided by hospital and community-based peer counselors is effective in improving exclusive breastfeeding rates among low-income , inner-city women in the United States BACKGROUND Breastfeeding peer counseling has improved breastfeeding rates in developing countries ; however , its impact in this country has not been adequately evaluated . OBJECTIVE To evaluate the effectiveness of an existing , breastfeeding peer counseling program within the United States . DESIGN R and omized , prospect i ve , controlled trial in which participants were recruited prenatally and r and omly assigned to receive either routine breastfeeding education or routine breastfeeding education plus peer counseling . SETTING An urban hospital serving a large population of low-income Latinas . PARTICIPANTS Pregnant women ( < or = 26 weeks ' gestation ) were recruited from the hospital 's prenatal clinic . Inclusion criteria specified that participants be low income , be considering breastfeeding , have delivered a healthy , full-term singleton , and have access to a telephone . Intervention Breastfeeding peer counseling services included 1 prenatal home visit , daily perinatal visits , 3 postpartum home visits , and telephone contact as needed . MAIN OUTCOME MEASURES Breastfeeding rates at birth and 1 , 3 , and 6 months postpartum . RESULTS The proportion not initiating breastfeeding was significantly lower in the intervention group than among controls ( 8/90 [ 9 % ] vs 17/75 [ 23 % ] ; relative risk , 0.39 ; 95 % confidence interval , 0.18 - 0.86 ) . The probability of stopping breastfeeding also tended to be lower in the intervention group at both 1 month ( 36 % vs 49 % ; relative risk , 0.72 ; 95 % confidence interval , 0.50 - 1.05 ) and 3 months ( 56 % vs 71 % ; relative risk , 0.78 ; 95 % confidence interval , 0.61 - 1.00 ) . CONCLUSION These findings demonstrate that , in the United States , peer counselors can significantly improve breastfeeding initiation rates and have an impact on breastfeeding rates at 1 and 3 months post partum This research examined the effect of peer support on breastfeeding duration and exclusivity ( breastfeeding without supplements ) in a population of low-income women during the first 3 months postpartum . Participants in the peer counselor group ( n = 18 ) exhibited higher rates of exclusive breastfeeding across time than those without a counselor ( n = 18 ) , and more exclusive breastfeeding was associated with long duration overall . Mother 's career plans had the greatest effect on duration of breastfeeding . Women who intended to return to work , attend school , or both breastfed 6 to 9 weeks less than participants who intended to stay home . Attendance at a breastfeeding class and knowing someone who had breastfed was significantly correlated with a longer duration of breastfeeding . Nutritionists from the Women , Infants and Children ( WIC ) Program were the primary source of breastfeeding information . Two main factors discouraged women from breastfeeding : returning to work , school , or both and the perception of a diminished milk supply . Greater emphasis should be placed on prenatal breastfeeding education for low-income women , and their mothers and gr and mothers should be included . Peer support is one important component of social support in the area of breastfeeding that community health nurses ( CHNs ) can utilize . CHNs are in a unique position to assist working moth
Output:
| For disadvantaged new and expectant mothers , peer or collaborative delivery models could be used in interventions . |
MS212225 | ***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 Despite the availability of multiple effective screening tests for colorectal cancer , screening rates remain suboptimal . The literature documents patient preferences for different test types and recommends a shared decision-making approach for physician-patient colorectal cancer screening ( CRCS ) discussion s , but it is unknown whether such communication about CRCS preferences and options actually occurs in busy primary -care setting s. OBJECTIVE Describe physician-patient CRCS discussion s during a wellness visit . DESIGN Cross-sectional ; patients audio-recorded with physicians . PARTICIPANTS A subset of patients ( N = 64 ) participating in a behavioral intervention trial design ed to increase CRCS who completed a wellness visit during the trial with a participating physician ( N = 8).APPROACHTranscripts were analyzed using qualitative methods . RESULTS Physicians in this sample consistently recommended CRCS , but focused on colonoscopy . Physicians did not offer a fecal occult blood test alone as a screening choice , which may have created missed opportunities for some patients to get screened . In this single visit , physicians ’ communication processes generally precluded discussion of patients ’ test preferences and did not facilitate shared decision-making . Patients ’ questions indicated their interest in different CRCS test types and appeared to elicit more information from physicians . Some patients remained resistant to CRCS after discussing it with a physician . CONCLUSION If a preference for colonoscopy is widespread among primary -care physicians , the implication s for intervention are either to prepare patients for this preference or to train physicians to offer options when recommending screening to patients Two methods of mass population screening for colorectal cancer - faecal occult blood testing and sigmoidoscopy - have been the subject of r and omized controlled trials in the UK . A national screening programme is currently under consideration and the choice of screening method remains open . To be successful , a programme will require high levels of uptake , and uptake is likely to depend upon subjects ' attitudes towards the screening method introduced . Although a preferred screening method has already been identified from a question naire survey , we undertook a further interview study ( n = 106 ) , with a view to comparing the results of two different approaches to eliciting public preferences . In comparison with the question naire study , a higher proportion of interview subjects stated a preference . Interview subjects were generally more favourably disposed towards sigmoidoscopy , excepting those with previous experience . Compared with the question naire survey , the interviews provided richer information on the reasons for preferences offered . Individual preferences were evidently subjective and dependant on attitudes towards a variety of method characteristics , such as discomfort , convenience and perceived sophistication . Characteristics such as age and low income , which had predicted preferences in the question naire study , predicted preferences in the interview study also . The difference between the results obtained by the different elicitation techniques can be explained in terms of the differential provision of information and sample selection . Conclusions made about public preferences are likely to depend on the technique employed in eliciting them Colorectal cancer is the second leading cause of cancer death in the United States.1 Appropriate screening can reduce incidence of and mortality from colorectal cancer.2–5 The US Preventive Services Task Force recommends that all average-risk individuals aged 50 years and older receive colorectal cancer screening.6 The American Cancer Society recommends several acceptable approaches to screening , including an annual 3-card home fecal occult blood test.7 The Healthy People 2010 objective is to increase the proportion of people aged 50 and older who have received a fecal occult blood test within the preceding 2 years to at least 50%.8 Lack of knowledge , confidence , and skills ; negative attitudes toward the tests themselves ; fear of the consequences of screening ; and inadequate social support all have been suggested as possible barriers to colorectal cancer screening,9 whereas positive attitudes toward colorectal cancer screening and physician encouragement have been associated with receipt of a fecal occult blood test with a home stool kit.10 Despite these studies , gaps remain in what is known about barriers to successful interventions to increase colorectal cancer screening , particularly in minority population s.11,12 This study is based on the assumption that identification and definition of barriers to colorectal cancer screening in low-income , underserved minority population s can help guide the development of effective interventions Background Colorectal cancer screening ( CRCS ) is the only type of cancer screening where both genders reduce risks by similar proportions with identical procedures . It is an important context for examining gender differences in disease-prevention , as CRCS significantly reduces mortality via early detection and prevention . In efforts to increase screening adherence , there is increasing acknowledgment that obstructive attitudes prevent CRCS uptake . Precise identification of the gender differences in obstructive attitudes is necessary to improve uptake promotion . This study r and omly sample d unscreened , screening - eligible individuals in Ontario , employing semi-structured interviews to elicit key differences in attitudinal obstructions towards colorectal cancer screening with the aim of deriving informative differences useful in planning promotions of screening uptake . Methods N = 81 participants ( 49 females , 32 males ) , 50 years and above , with no prior CRCS , were contacted via r and om-digit telephone dialing , and consented via phone-mail contact . Altogether , N = 4,459 calls were made to yield N = 85 participants ( 1.9 % response rate ) of which N = 4 participants did not complete interviews . All subjects were eligible for free-of-charge CRCS in Ontario , and each was classified , via st and ard interview by CRCS screening decision-stage . Telephone-based , semi-structured interviews ( SSIs ) were employed to investigate gender differences in CRCS attitudes , using questions focused on 5 attitudinal domains : 1 ) Screening experience at the time of interview ; 2 ) Barriers to adherence ; 3 ) Predictors of Adherence ; 4 ) Pain-anxiety experiences related to CRCS ; 5 ) Gender-specific experiences re : CRCS , addressing all three modalities accessible through Ontario ’s program : a ) fecal occult blood testing ; b ) flexible sigmoidoscopy ; c ) colonoscopy . Results Interview transcript analyses indicated divergent themes related to CRCS for each gender : 1 ) bodily intrusion , 2 ) perforation anxiety , and 3 ) embarrassment for females and ; 1 ) avoidant procrastination with underlying fatalism , 2 ) unnecessary health care and 3 ) uncomfortable vulnerability for males . Respondents adopted similar attitudes towards fecal occult blood testing , flexible sigmoidoscopy and colonoscopy , and were comparable in decision stage across tests . Gender differences were neither closely tied to screening stage nor modality . Women had more consistent physician relationships , were more screening-knowledgeable and better able to articulate views on screening . Men reported less consistent physician relationships , were less knowledgeable and kept decision-making processes vague and emotionally distanced ( i.e. at ‘ arm ’s length ’ ) . Conclusions Marked differences were observed in obstructive CRCS attitudes per gender . Females articulated reservations about CRCS-associated distress and males suppressed negative views while ambiguously procrastinating about the task of completing screening . Future interventions could seek to reduce CRCS-related stress ( females ) and address the need to overcome procrastination ( males ) INTRODUCTION Uptake is an important determinant of the effectiveness of population -based screening . Uptake of colorectal cancer ( CRC ) screening generally remains sub-optimal . AIM To determine factors influencing the decision whether to participate or not among individuals invited for faecal occult blood test ( FOBT ) or flexible sigmoidoscopy ( FS ) screening . METHODS A question naire was sent to a stratified r and om sample of individuals aged 50 - 74 , previously invited for a r and omised CRC screening trial offering FOBT or FS , and a reference group from the same population not previously invited ( screening naïve group ) . The question naire assessed reasons for (non)-participation , individuals ' characteristics associated with participation , knowledge , attitudes and level of informed choice . RESULTS The response rate was 75 % ( n=341/452 ) for CRC screening participants , 21 % ( n=676/3212 ) for non- participants and 38 % ( n=192/500 ) for screening-naïve individuals . The main reasons for FOBT and FS participation were acquiring certainty about CRC presence and possible early CRC detection . Anticipated regret and positive attitudes towards CRC screening were strong predictors of actual participation and intention to participate in a next round . The main reason for non-participation in FOBT screening was lack of abdominal complaints . Non-participation in FS screening was additionally influenced by worries about burden . Eighty-one percent of participants and 12 % of non- participants made an informed choice on participation . CONCLUSION Only 12 % of non- participants made an informed choice not to participate . These results imply that governments and /or organizations offering screening should focus on adequately informing and educating target population s about the harms and benefits of CRC screening . This may impact uptake of CRC screening While a wide range of behavioral and psychosocial literature explores attitudes and beliefs towards cancer screenings , fewer studies examine attitudes across cancer screening types . We draw on quantitative and qualitative findings from a 4-year prospect i ve study based at a community health center serving diverse , low-income patients . Methods included self-report surveys ( n = 297 ) , medical chart abstract ion , and several qualitative methods with a sub sample of participants . Participants included white , African – American , Vietnamese , and Latino patients who were diagnosed with diabetes , hypertension , or both . Patients ’ attitudes ( both positive and negative ) towards cancer screening types were remarkably consistent across cancer screening types . These effects were stronger among men than women . Never having had a cancer screening was generally associated with more unfavorable attitudes towards all screenings . Qualitative interviews indicate the importance of information circulated through social networks in shaping attitudes towards cancer screenings . Condensed abstract : In a multi- method study of attitudes towards cancer screening among medically underserved patients in a primary care setting , we found that attitudes ( both positive and negative ) were remarkably consistent across cancer screening types OBJECTIVE To identify barriers and facilitators associated with participation in the first round of a population -based program for colorectal cancer ( CRC ) in Catalonia , Spain and to identify strategies for motivating and supporting behavioral change . MATERIAL AND METHODS A two-part , mixed- methods design was used . In first place , a prospect i ve study of individuals aged 50 - 69 years ( n=1961 ) was conducted in 2006 - 2007 . Secondly , focus groups were undertaken with participants and non- participants of the CRC screening , in 2008 . RESULTS Intention to participate was an important determinant of participation ( 82.9 % vs 65.9 % , OR=2.56 , 95%CI:1.95 - 3.36 ) in addition to knowledge about CRC and its early detection . Respondents who reported that CRC may be asymptomatic in early stages enrolled in the screening program more frequently than those who thought CRC is always symptomatic ( 49.4 % vs 44.8 % , OR:1.82 ; 95%CI:1.3 - 2.6 ) . Barriers for participation mentioned in focus groups were competing perceived for other health problems and other dem and s as well as misunderst and ing about personal relevance of the screening . CONCLUSION Individuals ' perceptions of CRC are amenable to change through education-based interventions . Increasing public knowledge related to the burden of CRC and its preventive potential may be an effective way for improving participation in a population -based screening program Objectives To assess the acceptability of bowel cancer screening using flexible sigmoidoscopy ( FS ) . Setting Adults aged 55 to 64 recruited from general practice s in Welwyn Garden City and Leicester , which were the pilot and start up centres of a multicentred r and omised controlled trial of FS screening ( the ICRF/MRC Flexible Sigmoidoscopy Screening Trial ) . Methods Screenees ( n=4422 ) were sent a three month follow up question naire that included measures of satisfaction with information given before the test , facilities at the test unit , attitudes of the staff , and explanation of the results . Measures of pain , embarrassment , feelings of being “ in control ” during the test , willingness to encourage others to have the test , and gladness to have participated were also included . In addition , semistructured telephone interviews were conducted with 60 screenees , stratified by screening outcome and gender . Results The follow up question naire was completed by 94 % of screenees . Responses indicated a high level of satisfaction with the procedure : 99 % were satisfied with the information given before the test , the facilities , the attitudes of the staff , and the explanation of their results ; 91 % reported only mild or no pain ; 97 % reported little or no embarrassment ; and 99 % were glad they had the test . Satisfaction ratings varied little by gender or outcome group . The quantitative results were reinforced by the qualitative data , which also revealed high acceptability . Conclusion In the context of a clinical trial with dedicated trial staff , FS is a well tolerated procedure . There are high levels of satisfaction with service provision and positive attitudes towards the programme
Output:
| The decision to participate in colorectal cancer screening depended on an individual 's awareness of colorectal cancer screening .
Awareness affected views of cancer , attitudes towards colorectal cancer screening modalities , and motivation for screening .
Factors mediating awareness included public education to address misconceptions , primary care physician efforts to recommend screening , and the influence of friends and family .
Specific barriers to participation in population s with lower participation rates included language barriers , logistical challenges to attending screening tests , and cultural beliefs . |
MS212226 | ***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 assess whether VA MEDIC-E ( Veterans Affairs Multi-disciplinary Education and Diabetes Intervention for Cardiac risk reduction[EM DASH ] Extended for 6 months ) , a pharmacist-led shared medical appointments program , could improve attainment of target goals for hypertension , hyperglycemia , hyperlipidemia , and tobacco use in patients with type 2 diabetes compared to st and ard primary care after 6 months of intervention . Methods A r and omized , controlled trial of VA MEDIC-E ( n = 50 ) versus st and ard primary care ( n = 49 ) in veterans with type 2 diabetes , hemoglobin A1c ( A1C ) > 7 % , blood pressure ( BP ) > 130/80 mmHg , and low density lipoprotein cholesterol ( LDL-C ) > 100mg/dl ( 2.59 mmol/l ) in the previous 6 months was conducted . The VA MEDIC-E intervention consisted of 4 weekly group sessions followed by 5 monthly booster group sessions . Each 2-hour session included 1 hour of multidisciplinary diabetes specific healthy lifestyle education and 1 hour of pharmacotherapeutic interventions performed by a clinical pharmacist . Evaluation measures included lab values of A1C , LDL cholesterol , BP , and goal attainment of these values , and diabetes self-care behavior question naires at 6 months . Results The r and omization groups were similar at baseline in all cardiovascular risk factors except for LDL , which was significantly lower in the MEDIC-E arm . At 6 months , significant improvements from baseline were found in the intervention arm for exercise , foot care , and goal attainment of A1C , LDL-C , and BP but not in the control arm . Conclusions The results of this study demonstrate that the pharmacist-led group intervention program for 6 months was an efficacious and sustainable collaborative care approach to managing diabetes and reducing associated cardiovascular risk Purpose The purpose of this study was to assess whether the VA-MEDIC ( Veterans Affairs Multi-disciplinary Education and Diabetes Intervention for Cardiac risk reduction ) , a pharmacist-led group medical visit program , could improve achievement of target goals in hypertension , hyperglycemia , hyperlipidemia , and tobacco use in patients with type 2 diabetes compared to usual care . Methods This was a r and omized controlled trial of VA-MEDIC intervention in addition to usual care versus usual care alone in diabetic patients to reduce cardiac risk factors . VA-MEDIC consisted of a 40- to 60-minute educational component by nurse , nutritionist , physical therapist , or pharmacist followed by pharmacist-led behavioral and pharmacological interventions over 4 weekly sessions . Measures The attainment of target goals in hemoglobin A1C ( A1C ) , blood pressure , fasting lipids , and tobacco use recommended by the American Diabetes Association . Results Of 118 participants , 109 completed the study . VA-MEDIC ( n = 58 ) participants were younger and had greater tobacco use at baseline than usual care but were similar in other cardiovascular risk factors . After 4 months , a greater proportion of VA-MEDIC participants versus controls achieved an A1C of less than 7 % and a systolic blood pressure less than 130 mm Hg . No significant change was found in lipid control or tobacco use between the 2 study arms . Conclusion Pharmacist-led group medical visits are feasible and efficacious for improving cardiac risk factors Purpose : To study the effectiveness of multidisciplinary nurse practitioner coordinated team ( NPCT ) group visits in medically underserved Appalachia on the health , knowledge , and self‐efficacy of patients with type 2 diabetes ( DM ) . The study also identified perceived barriers to participating in the diabetes programs . Data sources : A research er‐developed tool was used to assess demographic data , clinical data , and barriers to care . The participants completed the Diabetes Knowledge Tests and the Diabetes Empowerment Scales . Two groups were assessed . One group participated in the diabetes intervention , and the other received usual care . Both groups completed the instruments prior to the intervention and after the intervention was completed . Conclusions : The group that participated in the intervention had better clinical outcomes ( blood glucose and A1Cs ) , greater knowledge , and better self‐efficacy following the intervention than the usual care groups . This suggests that the intervention was important in improving outcomes of patients with type 2 DM . Barriers to care included fuel , time , family , work , and transportation . Barriers need to be addressed in order to have more patients participate in such programs . Implication s for practice : NPCT group visits may represent an effective means of integrating diabetes self‐management education and medical management in a family practice clinic in medically underserved areas CONTEXT Emergency department utilization by chronically ill older adults may be an important sentinel event signifying a breakdown in care coordination . A primary care group visit ( i.e. , several patients meeting together with the provider at the same time ) may reduce fragmentation of care and subsequent emergency department utilization . OBJECTIVE To determine whether primary care group visits reduce emergency department utilization in chronically ill older adults . DESIGN R and omized trial conducted over a 2-year period . SETTING Group-model HMO in Denver , Colorado . PATIENTS 295 older adults ( > or = 60 years of age ) with frequent utilization of outpatient services and one or more chronic illnesses . INTERVENTION Monthly group visits ( generally 8 to 12 patients ) with a primary care physician , nurse , and pharmacist held in 19 physician practice s. Visits emphasized self-management of chronic illness , peer support , and regular contact with the primary care team . MEASURES Emergency department visits , hospitalizations , and primary care visits . RESULTS On average , patients in the intervention group attended 10.6 group visits during the 2-year study period . These patients averaged fewer emergency department visits ( 0.65 vs. 1.08 visits ; P = 0.005 ) and were less likely to have any emergency department visits ( 34.9 % vs. 52.4 % ; P = 0.003 ) than controls . These differences remained statistically significant after controlling for demographic factors , comorbid conditions , functional status , and prior utilization . Adjusted mean difference in visits was -0.42 visits ( 95 % CI , -0.13 to -0.72 ) , and adjusted RR for any emergency department visit was 0.64 ( CI , 0.44 to 0.86 ) . CONCLUSION Monthly group visits reduce emergency department utilization for chronically ill older adults OBJECTIVES To compare the effectiveness of Cooperative Health Care Clinic ( ( CHCC ) group outpatient model for chronically ill , older health maintenance organization ( HMO ) patients ) with usual care . DESIGN Two-year , r and omized , controlled trial conducted with recruitment from February 1995 through July of 1996 . SETTING Nonprofit group model HMO . PARTICIPANTS Two hundred ninety-four adults ( 145 intervention and 149 usual care ) , aged 60 and older ( mean age 74.1 ) with 11 or more outpatient visits in the prior 18 months , one or more self-reported chronic conditions , and expressed interest in participating in a group clinic . INTERVENTION Monthly group meetings held by patients ' primary care physicians . MEASUREMENT Differences in clinic visits , inpatient admissions , emergency room visits , hospital outpatient services , professional services , home health , and skilled nursing facility admissions ; measures of patient satisfaction , quality of life , self-efficacy , and activities of daily living ( ADLs ) . RESULTS Outpatient , pharmacy services , home health , and skilled nursing facility use did not differ between groups , but CHCC patients had fewer hospital admissions ( P=.012 ) , emergency visits ( P=.008 ) , and professional services ( P=.005 ) . CHCC patients ' costs were $ 41.80 per member per month less than those of control patients . CHCC patients reported higher satisfaction with their primary care physician ( P=.022 ) , better quality of life ( P=.002 ) , and greater self-efficacy ( P=.03 ) . Health status and ADLs did not differ between groups . CONCLUSION The CHCC model result ed in fewer hospitalizations and emergency visits , increased patient satisfaction , and self-efficacy , but no effect on outpatient use , health , or functional status OBJECTIVE To evaluate the effectiveness of a managed care approach to health care delivery , group visits , in the management of uninsured or inadequately insured patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 120 patients with uncontrolled type 2 diabetes were r and omly assigned to receive their care in group visits or usual care for 6 months . After 6 months , concordance with 10 process-of-care indicators recommended by the American Diabetes Association ( ADA ) st and ards of care was evaluated through chart abstract ion . The 10 items evaluated were up-to- date HbA(1c ) levels and lipid profiles , urine for microalbumin , appropriate use of ACE inhibitor or angiotensin receptor blockers , use of lipid-lowering agents where indicated , daily aspirin use , annual foot examinations , annual referrals for retinal examinations , and immunizations against streptococcal pneumonia and influenza . RESULTS Patients who received care in group visits showed statistically significant improvement in concordance with these 10 process-of-care indicators ( P < 0.001 ) . Of the patients , 76 % who received care in group visits had at least 9 of these 10 items up to date , as compared with 23 % of control patients ; 86 % of patients in group visits had at least 8 of the 10 indicators compared with 47 % of control patients . CONCLUSIONS Group visits proved more effective in promoting concordance with ADA st and ards of care than usual care in the treatment of uninsured or inadequately insured patients with type 2 diabetes OBJECTIVE To evaluate the impact of primary care group visits ( chronic care clinics ) on the process and outcome of care for diabetic patients . RESEARCH DESIGN AND METHODS We evaluated the intervention in primary care practice s r and omized to intervention and control groups in a large-staff model health maintenance organization ( HMO ) . Patients included diabetic patients > or = 30 years of age in each participating primary care practice , selected at r and om from an automated diabetes registry . Primary care practice s were r and omized within clinics to either a chronic care clinic ( intervention ) group or a usual care ( control ) group . The intervention group conducted periodic one-half day chronic care clinics for groups of approximately 8 diabetic patients in their respective doctor 's practice . Chronic care clinics consisted of st and ardized assessment s ; visits with the primary care physician , nurse , and clinical pharmacist ; and a group education/peer support meeting . We collected self-report question naires from patients and data from administrative systems . The question naires were mailed , and telephoned interviews were conducted for nonrespondents , at baseline and at 12 and 24 months ; we queried the process of care received , the satisfaction with care , and the health status of each patient . Serum cholesterol and HbA1c levels and health care use and cost data was collected from HMO administrative systems . RESULTS In an intention-to-treat analysis at 24 months , the intervention group had received significantly more recommended preventive procedures and helpful patient education . Of five primary health status indicators examined , two ( SF-36 general health and bed disability days ) were significantly better in the intervention group . Compared with control patients , intervention patients had slightly more primary care visits , but significantly fewer specialty and emergency room visits . Among intervention participants , we found consistently positive associations between the number of chronic care clinics attended and a number of outcomes , including patient satisfaction and HbA1c levels . CONCLUSIONS Periodic primary care sessions organized to meet the complex needs of diabetic patients imrproved the process of diabetes care and were associated with better outcomes BACKGROUND Current diabetes management guidelines offer blueprints for providers , yet type 2 diabetes control is often poor in disadvantaged population s. The group visit is a new treatment modality originating in managed care for efficient service delivery to patients with chronic health problems . Group visits offer promise for delivering care to diabetic patients , as visits are lengthier and can be more frequent , more organized , and more educational . OBJECTIVE To evaluate the effect of group visits on clinical outcomes , concordance with 10 American Diabetes Association ( ADA ) guidelines [ American Diabetes Association , Diabetes Care , 28:S4–36 , 2004 ] and 3 United States Preventive Services Task Force ( USPSTF ) cancer screens [ U.S. Preventive Services Task Force , http://www.ahrq.gov/clinic/uspstf/re source .htm , 2003 ] . RESEARCH DESIGN AND METHODS A 12-month r and omized controlled trial of 186 diabetic patients comparing care in group visits with care in the traditional patient – physician dyad . Clinical outcomes ( HbA1c , blood pressure [ BP ] , lipid profiles ) were assessed at 6 and 12 months and quality of care measures ( adherence to 10 ADA guidelines and 3 USPSTF cancer screens ) at 12 months . RESULTS At both measurement points , HbA1c , BP , and lipid levels did not differ significantly for patients attending group visits versus those in usual care . At 12 months , however
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| Nonbiophysical outcomes , including economic outcomes , were reported too infrequently to meta-analyze , or to draw conclusions from .
MA interventions improve biophysical outcomes among patients with diabetes .
There was inadequate literature to determine SMA effects on patient experience , utilization , and costs |
MS212227 | ***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: Elderly patients with end-stage renal disease often have protein and /or caloric malnutrition that severely affects general well-being and mortality . Uremia is associated with resistance to the action of growth hormone ( GH ) . This resistance could be of clinical importance in elderly dialysis patients . In the present study , the effects of GH treatment were assessed in elderly patients receiving chronic hemodialysis . Twenty hemodialysis patients with a mean age of 71.7 years ( range , 53 to 92 years ) were included on a 6-month , r and omized , double-blind , placebo-controlled trial of GH treatment . The dose of GH was 66.7 microgram/kg , administered subcutaneously three times weekly immediately after each dialysis session . Body composition was measured using total-body potassium levels , computed tomography of the lower leg , and bioelectrical impedance analysis . Serum albumin concentrations and h and grip strength were also measured . GH treatment increased the serum concentration of insulin-like growth factor-I ( IGF-I ) , IGF-I/IGF-binding protein-3 ratio , fat-free mass , and the serum concentration of albumin compared with placebo . The number of patients with serum albumin levels less than 40 g/L was reduced by a factor of three in the GH-treated group . H and grip strength increased in response to GH treatment compared with placebo . Six months of GH treatment in elderly hemodialysis patients produced anabolic effects , with improved muscle performance . Also , the number of patients with low albumin levels was markedly reduced , indicating improved nutritional status and /or attenuated catabolism . These are all important beneficial effects for individual patient outcomes BACKGROUND Serum albumin has limitations as a nutritional marker in patients undergoing peritoneal dialysis ( PD ) in that it is affected by inflammation , systemic disease , overhydration , and urinary and dialysate protein loss . H and grip strength is a simple , easily performed bedside test that has been shown to correlate with lean body mass in patients close to inception of dialysis . OBJECTIVE We evaluated the associations of h and grip strength with other clinical factors and examined its relations with mortality and cardiovascular death in PD patients . DESIGN We prospect ively enrolled 233 chronic PD patients and assessed h and grip strength and other variables at baseline and then followed the patients for a mean ( + /-SD ) of 30 + /- 14 mo . RESULTS Baseline h and grip strength was significantly associated with age , sex , height , diabetes , residual glomerular filtration rate ( GFR ) , and hemoglobin but not with C-reactive protein ( CRP ) . After adjustment for age , sex , and height , h and grip strength was most strongly correlated with lean body mass on the basis of creatinine kinetics ( r = 0.334 , P < 0.001 ) , followed by serum albumin and subjective global assessment . Both men and women who died had lower h and grip strengths than did those who remained alive ( P < 0.001 ) . After control for age , sex , diabetes , atherosclerotic vascular disease , GFR , hemoglobin , CRP , and serum albumin , greater h and grip strength was predictive of lower all-cause [ hazards ratio ( HR ) : 0.95 ( 95 % CI : 0.92 , 0.99 ) ; P = 0.005 ] and cardiovascular [ HR : 0.94 ( 0.90 , 0.98 ) ; P = 0.004 ] mortality . CONCLUSIONS H and grip strength not only is a marker of body lean muscle mass but also provides important prognostic information independent of other covariates , including CRP and serum albumin . Our data suggest that h and grip strength may be used in conjunction with serum albumin as a nutrition-monitoring tool in patients undergoing PD BACKGROUND & AIMS Muscle wasting is considered the best marker of protein-energy wasting in end-stage renal disease ( ESRD ) . We tested the usefulness of a simple observer subjective muscle atrophy ( MA ) grading in relation to morbidity and mortality in ESRD patients . METHODS In two different ESRD cohorts ( 265 incident patients starting dialysis and 221 prevalent hemodialysis patients ) , each patient 's degree of MA was visually grade d by a trained nurse on a scale from 1 to 4 as part of the subjective global assessment . This score was confronted with inflammatory and nutritional indexes as well as objective measurements of muscle atrophy . Patients were then prospect ively followed for up to four or six years , depending on the cohort . RESULTS Thirty percent of the incident and 39 % of the prevalent patients presented signs of MA . Across worsening MA scale , nutritional and anthropometric markers of muscle loss were incrementally poorer . Inflammation markers as well as the proportion of women became progressively higher . Female sex , presence of cardiovascular disease , inflammation and low insulin-like growth factor-1 levels were associated with increased significant odd ratios of MA in each cohort . After adjustment for age , sex , inflammation , diabetes , cardiovascular disease , glomerular filtration rate and /or time on hemodialysis , the hazard ratio of death for moderate/severe MA was 2.62 ( 95 % CI : 1.34 , 5.13 ; p=0.001 ) and 3.04 ( 95 % CI : 1.61 , 5.71 ; p=0.0001 ) in the incident and prevalent cohorts respectively . CONCLUSION Increased MA is more common in female dialysis patients and associated with inflammation , poor nutritional and anthropometric status , as well as a 3-fold increased 4 - 6 year mortality . Our data support the use of frequent MA and /or nutritional assessment s in the clinical practice Left ventricular hypertrophy ( LVH ) and inflammation independently increase risk for death in people who receive hemodialysis . A nonr and omized , controlled trial was conducted of the effect of short daily ( 6 sessions/wk of 3 h each ) or conventional ( three sessions/wk of 4 h each ) hemodialysis on LVH and inflammatory factors . A total of 26 short daily hemodialysis and 51 matched conventional hemodialysis patients were enrolled , and baseline and 12-mo measures of echocardiographic left ventricular mass index ( LVMI ) , serum C-reactive protein ( CRP ) , serum calcium and phosphorus , and erythropoietin resistance index were collected . Baseline characteristics were similar between groups except that hemoglobin and serum calcium were lower and serum phosphorus was higher in the short daily hemodialysis group . At 12-mo follow-up , short daily hemodialysis patients experienced a 30 % decrease in LVMI ( 154 + /- 33 to 108 + /- 25 ; P < 0.0001 ) . After adjustment for potential confounders , short daily hemodialysis ( beta = -41.63 , P = 0.03 ) and percentage decrease in serum phosphorus ( beta = -0.12 , P = 0.04 ) predicted a 12-mo decrease in LVMI . Among short daily hemodialysis patients , there were significant reductions in median CRP levels [ 1.22 interquartile range ( IQR ) ( 0.37 to 3.70 ) to 0.05 IQR ( 0.05 to 1.17 ) ; P < 0.01 ] and erythropoietin resistance index [ 19.5 IQR ( 8.6 to 37.6 ) to 10.5 IQR ( 5.5 to 14.6 ) ; P < 0.001 ] . There were no significant changes in LVMI , CRP , or erythropoietin resistance index in the conventional hemodialysis group . Short daily hemodialysis is associated with improved fluid and phosphorus management and a reduction in LVH and inflammatory factors compared with conventional hemodialysis . Future trials are needed to determine whether short daily hemodialysis can reduce morbidity and mortality in this high-risk population The object of this article was to determine the predictive value of risk factors for recurrent falls and the construction of a fall risk model as a contribution to a mobility assessment for the identification of community-dwelling elderly at risk for recurrent falling in general practice . The design was a prospect i ve cohort study ( n = 311 ) . There were four primary health care centers . A sample stratified on previous falls , age , and gender of community-dwelling elderly persons aged 70 years or over ( n = 311 ) was taken from the respondents to a mail question naire ( n = 1660 ) . They were visited at home to assess physical and mental health , balance and gait , mobility and strength . A 36-week follow-up with telephone calls every 6 weeks was conducted . Falls and fall injuries were measured . During follow-up 197 falls were reported by 33 % of the participants : one fall by 17 % and two or more falls by 16 % . Injury due to a fall was reported by 45 % of the fallers : 2 % hip fractures , 4 % other fractures , and 39 % minor injuries . A fall risk model for the prediction of recurrent falls with an area under the curve ( AUC ) of 0.79 , based on logistic regression analysis , showed that the main determinants for recurrent falls were : an abnormal postural sway ( OR 3.9 ; 95 % Cl 1.3 - 12.1 ) , two or more falls in the previous year ( OR 3.1 ; 95 % Cl 1.5 - 6.7 ) , low scores for h and grip strength ( OR 3.1 ; 95 % Cl 1.5 - 6.6 ) , and a depressive state of mind ( OR 2.2 ; 95 % CI 1.1 - 4.5 ) . To facilitate the use of the model for clinical practice , the model was converted to a " desk model " with three risk categories : low risk ( 0 - 1 predictor ) , moderate risk ( two predictors ) , and high risk ( > or =3 predictors ) . A fall risk model converted to a " desk model , " consisting of the predictors postural sway , fall history , h and dynamometry , and depression , provides added value in the identification of community-dwelling elderly at risk for recurrent falling and facilitates the prediction of recurrent falls OBJECTIVE To assess the usefulness of Duruöz 's H and Index ( DHI ) in patients undergoing haemodialysis . METHODS Patients receiving haemodialysis for more than 2 months were recruited r and omly . Demographic , clinical and functional characteristics of patients were evaluated . Functional assessment was performed with DHI , H and Functional Index ( HFI ) , Health Assessment Question naire ( HAQ ) , Purdue Pegboard , grip strength and 3 kinds of pinch strengths . DHI was correlated ( Spearman 's ) with the other functional parameters in assessing the convergent validity and with non-functional parameters in assessing the divergent validity . RESULTS Sixty patients with a mean age of 50.05 were recruited . The average duration of haemodialysis was 55.02 months . DHI is significantly correlated with HAQ , HFI , Purdue Pegboard scores , grip strength and 3 types of pinch strengths while no significant correlation was found with non-functional parameters . CONCLUSIONS DHI is a practical scale which is efficient in assessing accurately the functional disability of the h and in patients receiving haemodialysis
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| The analysed studies showed correlation between muscle function estimated by HGS and variables used in the assessment of muscle mass and nutritional status , as well as the prediction of clinical complications .
CONCLUSIONS The analysis indicates that HGS is a useful tool for continuous and systematic assessment of muscle mass related to nutritional status in patients on dialysis . |
MS212228 | ***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 purpose of this study was to investigate the effects of offering Therapeutic Touch ( TT ) as an adjunct to cognitive behavioral therapy ( CBT ) for people with chronic pain . Patients were r and omized to relaxation training ( control group ) or TT plus relaxation ( experimental ) . Subsequently , all participants attended a CBT program . Preprogram and postprogram data were examined to identify patterns of change in pain intensity , self-efficacy , unitary power , disability , and perceived distress . In addition , patterns of attrition were examined . Patients in this study who were r and omized to receive TT fared better in terms of enhanced self-efficacy and unitary power , as well as having lower attrition rates . Trends associated TT with less distress and disability . This pilot study suggests that offering TT as an adjunct to CBT may help to improve clinical outcomes , reduce program attrition , and promote unitary power in those who suffer with chronic pain OBJECTIVE Fibromyalgia is a common , chronic pain condition for which patients frequently use complementary and alternative medicine , including Reiki . Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment . DESIGN This was a factorial design ed , r and omized , sham-controlled trial in which participants , data collection staff , and data analysts were blinded to treatment group . SETTING /LOCATION The study setting was private medical offices in the Seattle , Washington metropolitan area . SUBJECTS The subjects were comprised 100 adults with fibromyalgia . INTERVENTION Four ( 4 ) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor r and omized to use direct touch or no touch ( distant therapy ) . OUTCOME MEASURES The primary outcome was subjective pain as measured by visual analog scale at weeks 4 , 8 , and 20 ( 3 months following end of treatment ) . Secondary outcomes were physical and mental functioning , medication use , and health provider visits . Participant blinding and adverse effects were ascertained by self-report . Improvement between groups was examined in an intention-to-treat analysis . RESULTS Neither Reiki nor touch had any effect on pain or any of the secondary outcomes . All outcome measures were nearly identical among the 4 treatment groups during the course of the trial . CONCLUSION Neither Reiki nor touch improved the symptoms of fibromyalgia . Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms Fatigue is an extremely common side effect experienced during cancer treatment and recovery . Limited research has investigated strategies stemming from complementary and alternative medicine to reduce cancer-related fatigue . This research examined the effects of Reiki , a type of energy touch therapy , on fatigue , pain , anxiety , and overall quality of life . This study was a counterbalanced crossover trial of 2 conditions : ( 1 ) in the Reiki condition , participants received Reiki for 5 consecutive daily sessions , followed by a 1-week washout monitoring period of no treatments , then 2 additional Reiki sessions , and finally 2 weeks of no treatments , and ( 2 ) in the rest condition , participants rested for approximately 1 hour each day for 5 consecutive days , followed by a 1-week washout monitoring period of no scheduled resting and an additional week of no treatments . In both conditions , participants completed question naires investigating cancer-related fatigue ( Functional Assessment of Cancer Therapy Fatigue subscale [ FACT-F ] ) and overall quality of life ( Functional Assessment of Cancer Therapy , General Version [ FACT-G ] ) before and after all Reiki or resting sessions . They also completed a visual analog scale ( Edmonton Symptom Assessment System [ ESAS ] ) assessing daily tiredness , pain , and anxiety before and after each session of Reiki or rest . Sixteen patients ( 13 women ) participated in the trial : 8 were r and omized to each order of conditions ( Reiki then rest ; rest then Reiki ) . They were screened for fatigue on the ESAS tiredness item , and those scoring greater than 3 on the 0 to 10 scale were eligible for the study . They were diagnosed with a variety of cancers , most commonly colorectal ( 62.5 % ) cancer , and had a median age of 59 years . Fatigue on the FACT-F decreased within the Reiki condition ( P=.05 ) over the course of all 7 treatments . In addition , participants in the Reiki condition experienced significant improvements in quality of life ( FACT-G ) compared to those in the resting condition ( P < .05 ) . On daily assessment s ( ESAS ) in the Reiki condition , presession 1 versus postsession 5 scores indicated significant decreases in tiredness ( P < .001 ) , pain ( P < .005 ) , and anxiety ( P<.01 ) , which were not seen in the resting condition . Future research should further investigate the impact of Reiki using more highly controlled design s that include a sham Reiki condition and larger sample sizes The purpose of this study was to evaluate the effect of Reiki as an alternative and complementary approach to treating community-dwelling older adults who experience pain , depression , and /or anxiety . Participants ( N = 20 ) were r and omly assigned to either an experimental or wait list control group . The pre- and posttest measures included the Hamilton Anxiety Scale , Geriatric Depression Scale-Short Form , Faces Pain Scale , and heart rate and blood pressure . The research design included an experimental component to examine changes in these measures and a descriptive component ( semi-structured interview ) to elicit information about the experience of having Reiki treatments . Significant differences were observed between the experimental and treatment groups on measures of pain , depression , and anxiety ; no changes in heart rate and blood pressure were noted . Content analysis of treatment notes and interviews revealed five broad categories of responses : Relaxation ; Improved Physical Symptoms , Mood , and Well-Being ; Curiosity and a Desire to Learn More ; Enhanced Self-Care ; and Sensory and Cognitive Responses to Reiki Purpose . This is a pilot study investigating the effect of healing touch ( HT ) on fatigue in breast cancer patients undergoing radiation therapy ( RT ) . Methods / Design . This study presents the results of a within-subjects design r and omized clinical trial where the treatment group was treated with HT , whereas the control group experienced sham therapy . The setting was a university RT clinic . The participants were breast cancer patients treated with lumpectomy or mastectomy , 21 to 75 years old with an Eastern Cooperative Oncology Group ( ECOG ) score of 0 to 2 . The intervention was a 45-minute session of HT or sham therapy once a week during RT . Outcome measures included fatigue , quality of life ( QOL ) , and anxiety/depression . Results . A total of 70 patients were approached , with 41 completing the study . At completion , the HT participants tended to report higher levels of fatigue , statistically significant for interference ( P = .010 ) and usual fatigue ( P = .024 ) . The control group tended to report greater reductions in fatigue relative to their own means than the HT group ( Cohen ’s d = 0.30 to 0.49 vs 0.06 to 0.18 , respectively ) . There were no statistically significant differences between the groups for QOL . Conclusions . Our enrollment and retention indicate that HT is feasible for women during RT . Our pilot findings do not support a beneficial effect of HT on fatigue or QOL . Future research may explore increasing dose and teasing out therapist effect PURPOSE / OBJECTIVES To determine whether provision of Reiki therapy during outpatient chemotherapy is associated with increased comfort and well-being . DESIGN Double-blind , r and omized clinical controlled trial . SETTING Outpatient chemotherapy center . SAMPLE 189 participants were r and omized to actual Reiki , sham Reiki placebo , or st and ard care . METHODS Patients receiving chemotherapy were r and omly placed into one of three groups . Patients received either st and ard care , a placebo , or an actual Reiki therapy treatment . A demographic tool and pre- and post-tests were given before and after chemotherapy infusion . MAIN RESEARCH VARIABLES Reiki therapy , sham Reiki placebo therapy , st and ard care , and self-reported levels of comfort and well-being pre- and postintervention . FINDINGS Although Reiki therapy was statistically significant in raising the comfort and well-being of patients post-therapy , the sham Reiki placebo also was statistically significant . Patients in the st and ard care group did not experience changes in comfort and well-being during their infusion session . CONCLUSIONS The findings indicate that the presence of an RN providing one-on-one support during chemotherapy was influential in raising comfort and well-being levels , with or without an attempted healing energy field . IMPLICATION S FOR NURSING An attempt by clinic nurses to provide more design ated one-to-one presence and support for patients while receiving their chemotherapy infusions could increase patient comfort and well-being Each therapeutic act may be seen as a result of multiple ingredients that may be specific or nonspecific [ 6 ] . Expectations , preferences , motivation , and patient-doctor interactions are examples of variables that may affect treatment outcome [ 6 , 7 ] . The changed spectrum of medical disorders ( shifted toward aging and chronicity ) and the interindividual differences in health priorities make the focus on single diseases potentially misleading , whereas there is growing awareness that the aim of the treatment should refer to personal goals ( from attainment of cure to prevention of recurrence , from removal of functional impairment to alleviation of symptoms ) [ 8 ] . EBM does not do justice to the importance of these interactions and provides an oversimplified and reductionistic view of treatment . Finally , the presence of investigators with substantial financial conflicts of interest in panels concerned with clinical guidelines and the excessive reliance of metaanalyses on industry-funded studies constitute two major sources of bias in literature interpretation [ 1 , 9 ] . Horwitz et al. [ 10 ] developed a method of clinical inquiry within RCT that can enhance the applicability of results to clinical decision making . Reanalyzing the BetaBlocker Heart Attack Trial , they found that propranolol reduced the risk of dying for the ‘ average ’ patient who survived an acute myocardial infa rct ion , whereas it was harmful in a subgroup characterized by specific cotherapy histories . If we accept the possibility that a treatment The gap between clinical guidelines developed by evidence -based medicine ( EBM ) and the real world of clinicians and patients has been widely recognized . There is currently little evidence that EBM has actually improved patient care [ 1 ] . It is thus not surprising that most of the time clinicians rely more on their own experience and that of their colleagues ( tacit knowledge or ‘ mindlines ’ ) than on explicit evidence from research [ 2 ] . Feinstein and Horwitz [ 3 ] were among the first to warn about excessive reliance on r and omized controlled trials ( RCT ) and meta-analyses that were not intended to answer questions about the treatment of individual patients . The results of these types of trials may show comparative efficacy of treatments for the average r and omized patient but not for those whose characteristics , such as severity of symptoms , comorbidity and other clinical features , depart from st and ard presentations [ 3 ] . In addition , meta-analyses often include highly heterogeneous studies and ascribe conflicting results to r and om variability , whereas different outcomes may reflect different patient population s , enrollment and protocol characteristics [ 4 ] . Even though personalized medicine , described as genomicsbased knowledge , has promised to approach each patient as the biological individual he/she is , the practical applications still have a long way to go and neglect of social and behavioral features may actually lead to ‘ depersonalized ’ medicine [ 5 ] . Other limitations have emerged over time . Received : July 11 , 2014 Accepted after revision : July 21 , 2014 Published online : December 24 , Background : Distant healing , a form of spiritual healing , is widely used for many conditions but little is known about its effectiveness . Methods : In order to evaluate distant healing in patients with a stable chronic condition , we r and omised 409 patients with chronic fatigue syndrome ( CFS ) from 14 private practice s for environmental medicine in Germany and Austria in a two by two factorial design to immediate versus deferred ( waiting for 6 months ) distant healing . Half the patients were blinded and half knew their treatment allocation . Patients were treated for 6 months and allocated to groups of 3 healers from a pool of 462 healers in 21 European countries with different healing traditions . Change in Mental Health Component Summary ( MHCS ) score ( SF-36 ) was the primary outcome and Physical Health Component Summary score ( PHCS ) the secondary outcome . Results : This trial population had very low quality of life and symptom scores at entry . There were no differences over 6 months in post-treatment MHCS scores between the treated and untreated groups . There was a non-significant outcome ( p = 0.11 ) for healing with PHCS ( 1.11 ; 95 % CI –0.255 to 2.473 at 6 months ) and a significant effect ( p = 0.027 ) for blinding ; patients who were unblinded became worse during the trial ( –1.544 ; 95 % CI –2.913 to –0.176 ) . We found no relevant interaction for blinding among treated patients in MHCS and PHCS . Expectation of treatment and duration of CFS added significantly to the model . Conclusions : In patients with CFS , distant healing appears to have no statistically significant effect on mental and physical health but the expectation of improvement did improve outcome OBJECTIVE Little is known about the effects of distant healing in chronically ill patients , the population most likely to see a healer in practice . This study investigated whether distant healing as found in normal practice with patients representative of those seeking treatment from healers changes patients ' quality of life substantially . METHOD R and omized , waiting-list controlled study of distant healing ( anonymous , amulet , and allowing for personal contact ) in chronically ill patients . OUTCOME MEASURE Patient-reported quality of life as expressed by the sum of all M
Output:
| CONCLUSIONS Energy healing has demonstrated some improvement in illness symptoms , however high level evidence consistently demonstrating efficacy is lacking . |
MS212229 | ***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 Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line . Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality CONTEXT Higher adherence to a Mediterranean-type diet is linked to lower risk for mortality and chronic diseases , but its association with cognitive decline is unclear . OBJECTIVE To investigate the association of a Mediterranean diet with change in cognitive performance and risk for dementia in elderly French persons . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 1410 adults ( > or = 65 years ) from Bordeaux , France , included in the Three-City cohort in 2001 - 2002 and reexamined at least once over 5 years . Adherence to a Mediterranean diet ( scored as 0 to 9 ) was computed from a food frequency question naire and 24-hour recall . MAIN OUTCOME MEASURES Cognitive performance was assessed on 4 neuropsychological tests : the Mini-Mental State Examination ( MMSE ) , Isaacs Set Test ( IST ) , Benton Visual Retention Test ( BVRT ) , and Free and Cued Selective Reminding Test ( FCSRT ) . Incident cases of dementia ( n = 99 ) were vali date d by an independent expert committee of neurologists . RESULTS Adjusting for age , sex , education , marital status , energy intake , physical activity , depressive symptomatology , taking 5 medications/d or more , apolipoprotein E genotype , cardiovascular risk factors , and stroke , higher Mediterranean diet score was associated with fewer MMSE errors ( beta = -0.006 ; 95 % confidence interval [ CI ] , -0.01 to -0.0003 ; P = .04 for 1 point of the Mediterranean diet score ) . Performance on the IST , BVRT , or FCSRT over time was not significantly associated with Mediterranean diet adherence . Greater adherence as a categorical variable ( score 6 - 9 ) was not significantly associated with fewer MMSE errors and better FCSRT scores in the entire cohort , but among individuals who remained free from dementia over 5 years , the association for the highest compared with the lowest group was significant ( adjusted for all factors , for MMSE : beta = -0.03 ; 95 % CI , -0.05 to -0.001 ; P = .04 ; for FCSRT : beta = 0.21 ; 95 % CI , 0.008 to 0.41 ; P = .04 ) . Mediterranean diet adherence was not associated with the risk for incident dementia ( fully adjusted model : hazard ratio , 1.12 ; 95 % CI , 0.60 to 2.10 ; P = .72 ) , although power to detect a difference was limited . CONCLUSIONS Higher adherence to a Mediterranean diet was associated with slower MMSE cognitive decline but not consistently with other cognitive tests . Higher adherence was not associated with risk for incident dementia IMPORTANCE Oxidative stress and vascular impairment are believed to partly mediate age-related cognitive decline , a strong risk factor for development of dementia . Epidemiologic studies suggest that a Mediterranean diet , an antioxidant-rich cardioprotective dietary pattern , delays cognitive decline , but clinical trial evidence is lacking . OBJECTIVE To investigate whether a Mediterranean diet supplemented with antioxidant-rich foods influences cognitive function compared with a control diet . DESIGN , SETTING , AND PARTICIPANTS Parallel-group r and omized clinical trial of 447 cognitively healthy volunteers from Barcelona , Spain ( 233 women [ 52.1 % ] ; mean age , 66.9 years ) , at high cardiovascular risk were enrolled into the Prevención con Dieta Mediterránea nutrition intervention trial from October 1 , 2003 , through December 31 , 2009 . All patients underwent neuropsychological assessment at inclusion and were offered retesting at the end of the study . INTERVENTIONS Participants were r and omly assigned to a Mediterranean diet supplemented with extravirgin olive oil ( 1 L/wk ) , a Mediterranean diet supplemented with mixed nuts ( 30 g/d ) , or a control diet ( advice to reduce dietary fat ) . MAIN OUTCOMES AND MEASURES Rates of cognitive change over time based on a neuropsychological test battery : Mini-Mental State Examination , Rey Auditory Verbal Learning Test ( RAVLT ) , Animals Semantic Fluency , Digit Span subtest from the Wechsler Adult Intelligence Scale , Verbal Paired Associates from the Wechsler Memory Scale , and the Color Trail Test . We used mean z scores of change in each test to construct 3 cognitive composites : memory , frontal ( attention and executive function ) , and global . RESULTS Follow-up cognitive tests were available in 334 participants after intervention ( median , 4.1 years ) . In multivariate analyses adjusted for confounders , participants allocated to a Mediterranean diet plus olive oil scored better on the RAVLT ( P = .049 ) and Color Trail Test part 2 ( P = .04 ) compared with controls ; no between-group differences were observed for the other cognitive tests . Similarly adjusted cognitive composites ( mean z scores with 95 % CIs ) for changes above baseline of the memory composite were 0.04 ( -0.09 to 0.18 ) for the Mediterranean diet plus olive oil , 0.09 ( -0.05 to 0.23 ; P = .04 vs controls ) for the Mediterranean diet plus nuts , and -0.17 ( -0.32 to -0.01 ) for the control diet . Respective changes from baseline of the frontal cognition composite were 0.23 ( 0.03 to 0.43 ; P = .003 vs controls ) , 0.03 ( -0.25 to 0.31 ) , and -0.33 ( -0.57 to -0.09 ) . Changes from baseline of the global cognition composite were 0.05 ( -0.11 to 0.21 ; P = .005 vs controls ) for the Mediterranean diet plus olive oil , -0.05 ( -0.27 to 0.18 ) for the Mediterranean diet plus nuts , and -0.38 ( -0.57 to -0.18 ) for the control diet . All cognitive composites significantly ( P < .05 ) decreased from baseline in controls . CONCLUSIONS AND RELEVANCE In an older population , a Mediterranean diet supplemented with olive oil or nuts is associated with improved cognitive function . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N35739639 BACKGROUND Data on the association between dietary patterns and age-related cognitive decline are inconsistent . OBJECTIVE To determine whether dietary patterns assessed by the alternate Mediterranean diet score ( aMED ) , the Healthy Eating Index-2010 ( HEI-2010 ) , the Alternate Healthy Eating Index 2010 ( AHEI-2010 ) , or the Dietary Approach to Stop Hypertension ( DASH ) diet score are associated with cognitive decline in older women , and to examine whether dietary patterns modify the risk for cognitive decline in women with hypertension . DESIGN Prospect i ve , longitudinal cohort study . Food frequency question naires were used to derive dietary patterns at baseline . Hypertension was defined as self-report of current drug therapy for hypertension or clinic measurement of systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg . PARTICIPANTS AND SETTING Postmenopausal women ( N=6,425 ) aged 65 to 79 years who participated in the Women 's Health Initiative Memory Study and were cognitively intact at baseline . MAIN OUTCOME MEASURES Cognitive decline was defined as cases of mild cognitive impairment ( MCI ) or probable dementia ( PD ) . Cases were identified through rigorous screening and expert adjudication . STATISTICAL ANALYSES PERFORMED Cox proportional hazards models with multivariable adjustment were used to estimate the relative risk for developing MCI or PD . RESULTS During a median follow-up of 9.11 years , we documented 499 cases of MCI and 390 of PD . In multivariable analyses we did not detect any statistically significant relationships across quintiles of aMED , HEI-2010 , DASH , and AHEI-2010 scores and MCI or PD ( P values for trend=0.30 , 0.44 , 0.23 , and 0.45 ) . In women with hypertension , we found no significant association between dietary patterns and cognitive decline ( P values for trend=0.19 , 0.08 , 0.07 , and 0.60 ) . CONCLUSIONS Dietary patterns characterized by the aMED , HEI-2010 , AHEI-2010 , or DASH dietary score were not associated with cognitive decline in older women . Adherence to a healthy dietary pattern did not modify the risk for cognitive decline in women with hypertension CONTEXT Both higher adherence to a Mediterranean-type diet and more physical activity have been independently associated with lower Alzheimer disease ( AD ) risk but their combined association has not been investigated . OBJECTIVE To investigate the combined association of diet and physical activity with AD risk . DESIGN , SETTING , AND PATIENTS Prospect i ve cohort study of 2 cohorts comprising 1880 community-dwelling elders without dementia living in New York , New York , with both diet and physical activity information available . St and ardized neurological and neuropsychological measures were administered approximately every 1.5 years from 1992 through 2006 . Adherence to a Mediterranean-type diet ( scale of 0 - 9 ; trichotomized into low , middle , or high ; and dichotomized into low or high ) and physical activity ( sum of weekly participation in various physical activities , weighted by the type of physical activity [ light , moderate , vigorous ] ; trichotomized into no physical activity , some , or much ; and dichotomized into low or high ) , separately and combined , were the main predictors in Cox models . Models were adjusted for cohort , age , sex , ethnicity , education , apolipoprotein E genotype , caloric intake , body mass index , smoking status , depression , leisure activities , a comorbidity index , and baseline Clinical Dementia Rating score . MAIN OUTCOME MEASURE Time to incident AD . RESULTS A total of 282 incident AD cases occurred during a mean ( SD ) of 5.4 ( 3.3 ) years of follow-up . When considered simultaneously , both Mediterranean-type diet adherence ( compared with low diet score , hazard ratio [ HR ] for middle diet score was 0.98 [ 95 % confidence interval { CI } , 0.72 - 1.33 ] ; the HR for high diet score was 0.60 [ 95 % CI , 0.42 - 0.87 ] ; P = .008 for trend ) and physical activity ( compared with no physical activity , the HR for some physical activity was 0.75 [ 95 % CI , 0.54 - 1.04 ] ; the HR for much physical activity was 0.67 [ 95 % CI , 0.47 - 0.95 ] ; P = .03 for trend ) were associated with lower AD risk . Compared with individuals neither adhering to the diet nor participating in physical activity ( low diet score and no physical activity ; absolute AD risk of 19 % ) , those both adhering to the diet and participating in physical activity ( high diet score and high physical activity ) had a lower risk of AD ( absolute risk , 1
Output:
| Dose-response analysis indicated a trend of an approximately linear relationship of the Mediterranean diet score with the incident risk of cognitive disorders . |
MS212230 | ***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 Malignant pericardial effusion , although highly variable , is an uncommon complication of cancer . It is often associated with symptoms like dyspnea , chest pain , and cough , which may be severe and disabling . We analyzed the results of our current treatment policy to evaluate the effectiveness and tolerance of a new approach for this disorder . PATIENTS AND METHODS Patients with malignant pericardial effusions were treated with intracavitary thiotepa ( 15 mg on days 1 , 3 , and 5 ) through an indwelling pericardial cannula after extraction of as much pericardial fluid as possible on day 0 . Responses were assessed by clinical examination , computed tomographic ( CT ) scan , and echocardiography before treatment , 1 month after treatment , and every 2 months thereafter . Twenty-three patients with malignant symptomatic pericardial effusion were treated and all were assessable for effectiveness and tolerance of the procedure . RESULTS Nine patients with breast cancer , 11 with lung cancer , two with an unknown primary tumor , and one with metastatic melanoma were treated . In all but three patients , systemic medical treatment was started after completion of intracavitary therapy . Nineteen patients responded to treatment ( 83 % ; 95 % confidence interval , 61 % to 95 % ) with a rapid improvement of symptoms . The median time to pericardial effusion progression was 8.9 months ( range , 1 to 26 ) . No significant side effects were registered , except one patient who had transient grade III thrombocytopenia and leukopenia and one patient who had grade I leukopenia . CONCLUSION A short course of intracavitary treatment with thiotepa is highly effective and well tolerated in the treatment of malignant pericardial effusion OBJECTIVES This study describes the technique , clinical characteristics and results of the first 50 patients undergoing percutaneous balloon pericardiotomy as part of a multicenter registry . BACKGROUND Percutaneous balloon pericardiotomy involves the use of a percutaneous balloon dilating catheter to create a nonsurgical pericardial window . METHODS Patients eligible for percutaneous balloon pericardiotomy had either cardiac tamponade ( n = 36 ) or a moderate to large pericardial effusion ( n = 14 ) . In addition to clinical follow-up , serial echocardiograms and chest X-ray films were obtained . RESULTS The procedure was considered successful in 46 patients after a mean follow-up period of 3.6 + /- 3.3 months . Two patients required an early operation , one for bleeding from a pericardial vessel and one for persistent pericardial catheter drainage . Two patients required a late operation for recurrent tamponade . Minor complications of the procedure included fever in 6 of the first 37 patients ( studied before the prophylactic use of antibiotic agents ) , thoracentesis or chest tube placement in 8 and a small spontaneously resolving pneumothorax in 2 . Despite the short-term success of this procedure , the long-term prognosis of the 44 patients with malignant pericardial disease remained poor ( mean survival time 3.3 + /- 3.1 months ) . CONCLUSIONS Percutaneous balloon pericardiotomy is successful in helping to manage large pericardial effusions , particularly in patients with a malignant condition . It may become the preferred treatment to avoid a more invasive procedure for patients with pericardial effusion and a limited life expectancy We review ed 36 cases of symptomatic malignant pericardial effusion managed with pericardiocentesis at our institution from 1982 to 1989 . There were 13 men and 23 women , aged 49 + /- 12 years ( range , 33 - 76 years ) . The commonest underlying tumours were lung cancer ( 12 cases , 33 % ) and breast cancer ( 11 cases , 30 % ) . Pericardiocentesis was successful as the initial management in 34 of 36 patients ( 94 % ) ; one patient died as a result of the procedure and another required subxiphoid incision and tube drainage of the effusion . When intrapericardial sclerotherapy was performed , only three of 28 patients required repeat pericardiocentesis , and when sclerotherapy was not performed initially , four of seven patients had recurrent symptomatic effusions . Median survival following pericardiocentesis in breast cancer patients was 10 months ( range , 0 - 36 months ) and in all other malignancies was four months ( range , 0 - 12 months ) . We conclude that pericardiocentesis with intrapericardial sclerotherapy provides good local control for symptomatic malignant pericardial effusion in the majority of patients . In spite of this , the median survival of such patients is poor , especially in patients with malignancies other than breast cancer , with few patients surviving more than a few months PURPOSE To compare the clinical efficacy and toxicity of doxycycline and bleomycin as sclerosing agents in the primary management of malignant pericardial effusion ( MPE ) . METHODS Twenty-seven consecutive adult patients referred to a tertiary-care institution for the management of cardiac tamponade and malignancy underwent pericardial drainage through a percutaneously placed pigtail catheter . They were then alternately assigned to undergo bleomycin or doxycycline pericardial sclerosis . RESULTS There were 13 men and 14 women , with a median age of 59 years . They mainly had lung ( 70 % ) and breast cancers ( 11 % ) , and all had clinical and echocardiographic evidence of cardiac tamponade . Although all patients had successfully placed catheters , six were inadvertently dislodged before sclerosis ; 11 underwent bleomycin sclerosis and 10 doxycycline sclerosis . Twenty patients ( one early death ) were assessable . One patient in each group failed to respond to sclerosis with the initial agent , but both were sclerosed successfully with the other agent . Sclerosis was achieved with a median of two instillations for each agent and total median doses of bleomycin 20 mg and doxycycline 1,250 mg . Seventy percent of doxycycline patients developed significant retrosternal pain , compared with no bleomycin patients ( P = .04 ) . Doxycycline patients required a median of 3.5 more days of hospitalization ( 8.5 v 5 ) and 2 more days of pericardial catheterization ( 7 v 5 ) compared with bleomycin patients . Tamponade recurred in one bleomycin patient at 253 days , and in no doxycycline patient . CONCLUSION Although bleomycin and doxycycline are equally effective sclerosing agents , bleomycin is associated with significantly less morbidity and should be the first-line chemical sclerosing agent for malignant pericardial effusions
Output:
| Although isolated pericardiocentesis can safely deliver immediate symptomatic relief , subsequent catheter drainage or sclerotherapy are required to minimize recurrence .
PBP has been shown to be highly effective and may be particularly useful in managing recurrent effusions . |
MS212231 | ***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: Millennium Development Goal ( MDG ) 5 commits us to reducing maternal mortality rates by three quarters and MDG 4 commits us to reducing child mortality by two-thirds between 1990 and 2015 . In order to reach these goals , greater access to basic emergency obstetric care ( EmOC ) as well as comprehensive EmOC which includes safe Caesarean section , is needed .. The limited capacity of health systems to meet dem and for obstetric services has led several countries to utilize mid-level cadres as a substitute to more extensively trained and more internationally mobile healthcare workers . Although this does provide greater capacity for service delivery , concern about the performance and motivation of these workers is emerging . We propose that poor leadership characterized by inadequate and unstructured supervision underlies much of the dissatisfaction and turnover that has been shown to exist amongst these mid-level healthcare workers and indeed health workers more generally . To investigate this , we conducted a large-scale survey of 1,561 mid-level cadre healthcare workers ( health workers trained for shorter periods to perform specific tasks e.g. clinical officers ) delivering obstetric care in Malawi , Tanzania , and Mozambique . Participants indicated the primary supervision method used in their facility and we assessed their job satisfaction and intentions to leave their current workplace . In all three countries we found robust evidence indicating that a formal supervision process predicted high levels of job satisfaction and low intentions to leave . We find no evidence that facility level factors modify the link between supervisory methods and key outcomes . We interpret this evidence as strongly supporting the need to strengthen leadership and implement a framework and mechanism for systematic supportive supervision . This will promote better job satisfaction and improve the retention and performance of obstetric care workers , something which has the potential to improve maternal and neonatal outcomes in the countdown to 2015 QUALITY PROBLEM Research in Kenya in the mid-1990s suggested poor quality family planning services and limited access to services . Clinical guidelines for family planning and reproductive health were published in 1991 and up date d in 1997 , but never widely distributed . CHOICE OF SOLUTION Managers and trainers chose intensive , district-level training workshops to disseminate guidelines and up date health workers on guideline content and best practice s. INTERVENTION Training workshops were held in 41 districts in 1999 . Trainees were instructed to up date their untrained co-workers afterwards . As a reinforcement , providers in r and omly selected areas received a ' cascade training package ' of instructional material s and training tips . Providers in 15 r and omly selected clinics also received ' supportive supervision ' visits as a second reinforcement . EVALUATION METHODOLOGY A cluster-r and omized experiment in 72 clinics assessed the overall impact of the training and the marginal benefits of the two reinforcing activities . Research ers and trainers created several dozen indicators of provider knowledge , attitudes , beliefs and practice s. Binomial and multivariate analyses were used to compare changes over time in indicators and in aggregated summary scores . Data from patient interviews were analysed to corroborate provider practice self-reports . Cost data were collected for an economic evaluation . RESULTS Post-test data collected in 2000 showed that quality of care and access increased after the intervention . The cascade training package showed less impact than supportive supervision , but the former was more cost-effective . LESSONS LEARNED Service delivery guidelines , when properly disseminated , can improve family planning practice s in sub-Saharan Africa OBJECTIVES We evaluated an intervention to support health workers after training in Integrated Management of Childhood Illness ( IMCI ) , a strategy that can improve outcomes for children in developing countries by encouraging workers ' use of evidence -based guidelines for managing the leading causes of child mortality . METHODS We conducted a r and omized trial in Benin . We administered a survey in 1999 to assess health care quality before IMCI training . Health workers then received training plus either study supports ( job aids , nonfinancial incentives , and supervision of workers and supervisors ) or usual supports . Follow-up surveys conducted in 2001 to 2004 assessed recommended treatment , recommended or adequate treatment , and an index of overall guideline adherence . RESULTS We analyzed 1244 consultations . Performance improved in both intervention and control groups , with no significant differences between groups . However , training proceeded slowly , and low- quality care from health workers without IMCI training diluted intervention effects . Per- protocol analyses revealed that workers with IMCI training plus study supports provided better care than did those with training plus usual supports ( 27.3 percentage-point difference for recommended treatment ; P < .05 ) , and both groups outperformed untrained workers . CONCLUSIONS IMCI training was useful but insufficient . Relatively inexpensive supports can lead to additional improvements
Output:
| MAIN RESULTS Supportive supervision can increase job satisfaction and health worker motivation .
Evidence is mixed on whether this translates to increased clinical competence and there is little evidence of the effect on clinical outcomes . |
MS212232 | ***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 Comparison of Reverse Foam Sclerotherapy of the great saphenous vein ( GSV ) combed with sapheno-femoral junction ( SFJ ) ligation to st and ard ( Babcock ) stripping and invagination ( Pin ) stripping in a prospect i ve clinical series . DESIGN Prospect i ve clinical series . MATERIAL S AND METHODS 90 consecutive limbs of 82 patients with incompetence of the GSV result ing in varicose veins were prospect ively r and omised into 3 groups of 30 , treated by SFJ ligation and either reverse foam sclerotherapy , st and ard stripping or invagination stripping of the GSV . Outcomes were assessed post-operatively and at 2-weeks follow-up . Peri-operative blood loss ( 24 hrs ) , analgesic requirement , bruising and residual varicosities were assessed . Bruising was assessed by both patients and independent assessors using question naires . RESULTS SFJ ligation plus reverse foam sclerotherapy of the GSV was associated with significantly less blood loss , bruising and post-op discomfort than either of the stripping techniques . ( p<0.001 , Mann-Whitney ) CONCLUSION St and ard stripping of the GSV and invagination stripping are not associated with major discomfort and problems in the early post-operative period . SFJ ligation and GSV reverse foam sclerotherapy yielded greater patient satisfaction with less post-op bruising and discomfort and reduced analgesic requirements Endovenous laser ablation ( EVLA ) and radiofrequency ablation ( RFA ) are both associated with excellent technical , clinical and patient‐reported outcomes for the treatment of varicose veins . The aim of this study was to compare the techniques in a r and omized clinical trial BACKGROUND Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins , but their comparative effectiveness and safety remain uncertain . METHODS In a r and omized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom , we compared the outcomes of foam , laser , and surgical treatments . Primary outcomes at 6 months were disease-specific quality of life and generic quality of life , as measured on several scales . Secondary outcomes included complications and measures of clinical success . RESULTS After adjustment for baseline scores and other covariates , the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery ( P=0.006 ) but was similar in the laser and surgery groups . There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life . The frequency of procedural complications was similar in the foam group ( 6 % ) and the surgery group ( 7 % ) but was lower in the laser group ( 1 % ) than in the surgery group ( P<0.001 ) ; the frequency of serious adverse events ( approximately 3 % ) was similar among the groups . Measures of clinical success were similar among the groups , but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group ( P<0.001 ) . CONCLUSIONS Quality -of-life measures were generally similar among the study groups , with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group . All treatments had similar clinical efficacy , but complications were less frequent after laser treatment and ablation rates were lower after foam treatment . ( Funded by the Health Technology Assessment Programme of the National Institute for Health Research ; Current Controlled Trials number , IS RCT N51995477 . ) OBJECTIVES This study aims to compare the efficacy and side effects of foam sclerotherapy of the saphenous veins with or without post-treatment compression using graduated elastic stockings . DESIGN This is a prospect i ve open r and omised controlled trial conducted in two centres . PATIENTS AND METHODS Sixty patients with incompetent great ( GSV ) or small saphenous veins ( SSV ) underwent ultrasound-guided foam sclerotherapy . R and omisation was conducted immediately after sclerotherapy to two parallel groups , one ( CG ) with compression stockings ( 15 - 20 mmHg worn during the day , for 3 weeks ) and the other ( WCG ) without compression . Efficacy of sclerotherapy and all of the side effects were assessed , including side effects in the treated region . On days 14 and 28 , clinical and duplex ultrasound ( DUS ) assessment s were performed by independent experts . Patients also completed quality of life ( QOL ) , symptom question naires and provided satisfaction scores . RESULTS Five men and 55 women ranging in age from 32 to 78 ( mean 57 years ) years were included : 29 in the WCG and 31 in the CG group . On day 28 , abolition of venous reflux and occlusion of the vein was obtained in 100 % of the cases in both groups . The length of the occluded vein was the same in both groups ( mean 36 cm for the GSV and 30 cm for the SSV ) as was the mean diameter of the occluded vein ( 5 mm ) . Symptoms and QOL question naires showed equivalent improvement in both groups on day 28 compared to pre-treatment assessment s. Side effects were few with no statistical difference between the two groups . Patient satisfaction scores were high in both groups for the outcome of sclerotherapy results , and good or very good for compression in 50 % of the CG cases . CONCLUSION We found no difference between compression and control groups when comparing efficacy , side effects , satisfaction scores , symptoms and QOL . Further studies are required to establish the role of compression in sclerotherapy and to evaluate other compression strategies OBJECTIVES Comparison of sapheno-femoral ligation and stripping ( SFL/S ) versus endovenous laser ablation ( EVLA , 980-nm ) in the treatment of great saphenous vein ( GSV ) insufficiency , using local tumescent anaesthesia . DESIGN R and omised , single centre trial . MATERIAL S AND METHODS Patients with GSV incompetence and varicose veins were r and omised to either SFL/S or EVLA . At days 1 , 2 , 3 , 7 , 10 , and 14 post-treatment , patients completed question naires on pain and quality of life . Recurrent varicose veins were evaluated by Duplex ultrasound ( DUS ) performed at 1 and 6 weeks , and 6 and 12 months . RESULTS 130 legs in 121 patients were treated by SFL/S ( n=68 ) or EVLA ( n=62 ) . Significantly more post-treatment pain was noted after EVLA at days 7 , 10 and 14 ( p<0.01 ; p<0.01 ; p=0.01 ) , more hindrance in mobility at days 7 ( p<0.01 ) and 10 ( p=0.01 ) , and in self care ( p=0.03 ) and daily activities ( p=0.01 ) at day 7 compared to SFL/S. DUS at 1-year follow-up showed 9 % recurrences ( 5/56 ) after EVLA and 10 % ( 5/49 ) after SFL/S. CONCLUSION Both SFL/S and EVLA , using local tumescent anaesthesia , were well tolerated , with no difference in short-term recurrence rate . In the second week after EVLA , patients experienced significantly more pain result ing in restricted mobility , self care and daily activity compared to Introduction : Chronic venous insufficiency is the most common vascular disease in the adult population . However , r and omized clinical trials ( RCTs ) comparing therapeutic options are limited . Patients and Methods : A total of 180 patients with saphenofemoral junction and great saphenous reflux detected on duplex were r and omized to either ultrasound-guided radiofrequency ablation ( RFA ) or st and ard surgical treatment . The study participants blindly chose an assignment card that placed them in either group A ( ultrasound-guided RFA of the great saphenous vein [ GSV ] ; n = 90 ) ; or group B ( surgical management n = 90 ) . Patients were followed up for 24 months . Results : The primary occlusion rate in group A was 94.5 % versus 100 % in group B. Radiofrequency ablation had a lower overall complication rate ( P = .02 ) and shorter post-intervention hospital stay ( P = .001 ) . Kaplan-Meier analysis showed no significant differences in recurrence rates at 24 months follow-up ( P = .45 ) . Radiofrequency ablation was significantly more expensive ( P = .003 ) . Conclusion : Great saphenous vein occlusion was achieved efficiently in 94 % of our group using RFA with minimal complications and obvious advantages as compared to st and ard surgery Endovenous laser ablation ( EVLA ) is a popular minimally invasive treatment for varicose veins . Surgical treatment , featuring junctional ligation and inversion stripping , has shown excellent clinical and cost effectiveness . The clinical effectiveness of both treatments was compared within a r and omized trial AIM Major side effects after endovenous laser ablation ( EVLA ) are pain and bruising . The aim of this study was to compare outcome and side effects after EVLA of incompetent great saphenous veins ( GSV ) with a 1 470 nm diode laser ( Ceralas E , biolitec ) using a power of 15 or 25 W. METHODS Between 28 November 2007 and 15 January 2008 , 40 consecutive patients ( 40 legs ) with an incompetent GSV were treated by EVLA . The patients were r and omized in two groups . In Group A ( 20 patients ) was used a 15-W-power laser and in Group B ( 20 patients ) a 25-W-power laser was used . All patients were re-examined after 1 , 10 and 30 days clinical ly and by Duplex for complications and occlusion in the treated vein segment in a st and ardized way . RESULTS There was no significant difference concerning gender , age , C of CEAP , body mass index or diameter of the treated vein . In Group A a mean of 465 mL tumescence fluid ( TF ) was used and in Group B TF was of 433 mL. In Group A the mean linear endovenous energy density ( LEED ) was 109.7 J/cm and in Group B 132.6 J/cm . The subgroup Bsub included 16 patients of Group B with a comparable mean LEED of 115.8 J/cm . In all groups occlusion of the treated veins was achieved for all patients . The diameter of the GSV reduced at 3 cm below the sapheno-femoral junction from 1.1 to 0.6 cm , 1.0 to 0.6 cm and 0.9 to 0.6 cm respectively in the three groups . The modified CEAP clinical score improved significantly in all groups . In Group A patients have been administered analgesic tablets for a shorter period . There was also a trend to less postinterventional pain and analgesic use in Group A , but it was not significant . Ecchymosis was rare in both groups ( 8 in Group A , 7 in Group B ) . CONCLUSIONS In this prospect i ve r and omized comparative study the power of the laser did not influence the occlusion rate when a high LEED with comparable values was used . In both groups pain and ecchymoses were less frequent in this study with a 1 470 nm diode laser than reported in studies with 810 - 980 nm systems . A lower power level significantly reduced use of analgesic tablets BACKGROUND Great saphenous vein ( GSV ) incompetence is the most common cause of superficial venous insufficiency . Radiofrequency catheter ablation ( RFA ) is superior to conventional ligation and stripping , and endovenous laser treatment ( EVL ) has emerged as an effective alternative to RFA . This r and omized study evaluated RFA and EVL for superficial venous insufficiency due to GSV incompetence and compared early and 1-year results . METHODS Between June 2006 and May 2008 , patients with symptomatic primary venous insufficiency due to GSV incompetence were r and omized to RFA or EVL . Patients with bilateral disease were r and omized for treatment of the first leg and received the alternative method on the other . Pretreatment examination included a leg assessment using the Venous Clinical Severity Score ( VCSS ) and CEAP classification . Patients completed the Chronic Venous Insufficiency Question naire 2 ( CIVIQ2 ) . RFA was performed with the ClosurePlus system ( VNUS Medical Technologies , Sunnyvale , Calif ) . EVL was performed with the EVLT system ( AngioDynamics Inc , Queensbury , NY ) . Early ( 1-week and 1-month ) postoperative results of pain , bruising , erythema , and hematoma were recorded . Duplex ultrasound ( DU ) imaging was used at 1 week and 1 year to evaluate vein status . VCSS scores and CEAP clinical class were recorded at each postoperative visit , and quality of life ( QOL ) using CIVIQ2 was assessed at 1 month and 1 year . RESULTS The study enrolled 118 patients ( 141 limbs ) : 46 ( 39 % ) were r and omized to RFA and 48 ( 40 % ) to EVL , and 24 ( 20 % ) had bilateral GSV incompetence . At 1 week , one patient in the RFA group had an open GSV and
Output:
| Conclusions A lack of evidence as to the optimal strategy for compression has result ed in a marked variation in clinical practice . |
MS212233 | ***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 is compelling evidence that intranasal administration of regular human insulin ( RH-I ) improves memory in humans . Owing to the reduced tendency of its molecules to form hexamers , the rapid-acting insulin analog insulin aspart ( ASP-I ) is more rapidly absorbed than RH-I after subcutaneous administration . Since after intranasal insulin administration , ASP-I may also be expected to access the brain , we examined whether intranasal ASP-I has stronger beneficial effects on declarative memory than RH-I in humans . Acute ( 40 IU ) and long-term ( 4 × 40 IU/day over 8 weeks ) effects of intranasally administered ASP-I , RH-I , and placebo on declarative memory ( word lists ) were assessed in 36 healthy men in a between-subject design . Plasma insulin and glucose levels were not affected . After 8 weeks of treatment , however , word list recall was improved compared to placebo in both the ASP-I ( p<0.01 ) and the RH-I groups ( p<0.05 ) . ASP-I-treated subjects performed even better than those of the RH-I-treated group ( p<0.05 ) . Our results indicate that insulin-induced memory improvement can be enhanced by using ASP-I. This finding may be especially relevant for a potential clinical administration of intranasal insulin in the treatment of memory disorders like Alzheimer 's disease Background : Long acting insulin detemir administered intranasally for three weeks enhanced memory for adults with Alzheimer ’s disease dementia ( AD ) or amnestic mild cognitive impairment ( MCI ) . The investigation of longer-term administration is necessary to determine whether benefits persist , whether they are similar to benefits provided by regular insulin , and whether either form of insulin therapy affects AD biomarkers . Objective : The present study aim ed to determine whether four months of treatment with intranasal insulin detemir or regular insulin improves cognition , daily functioning , and AD biomarkers for adults with MCI or AD . Methods : This r and omized , double-blind , placebo-controlled trial included an intent-to-treat sample consisting of 36 adults diagnosed with MCI or mild to moderate AD . Participants received placebo ( n = 12 ) , 40 IU of insulin detemir ( n = 12 ) , or 40 IU of regular insulin ( n = 12 ) daily for four months , administered with a nasal delivery device . A cognitive battery was administered at baseline and after two and four months of treatment . MRI was administered for all participants and lumbar puncture for a subset ( n = 20 ) at baseline and four months . The primary outcome was change from baseline to four months on a memory composite ( sum of Z scores for delayed list and story recall ) . Secondary outcomes included : global cognition ( Alzheimer ’s Disease Assessment Scale-Cognition ) , daily functioning ( Dementia Severity Rating Scale ) , MRI volume changes in AD-related regions of interest , and cerebrospinal fluid AD markers . Results : The regular insulin treated group had better memory after two and four months compared with placebo ( p < 0.03 ) . No significant effects were observed for the detemir-assigned group compared with the placebo group , or for daily functioning for either group . Regular insulin treatment was associated with preserved volume on MRI . Regular insulin treatment was also associated with reduction in the tau-P181/Aβ42 ratio . Conclusion : Future research is warranted to examine the mechanistic basis of treatment differences , and to further assess the efficacy and safety of intranasal insulin Mild-to-moderate AD patients were r and omized to placebo or rosiglitazone ( RSG ) 2 , 4 or 8 mg . Primary end points at Week 24 were mean change from baseline in AD Assessment Scale-Cognitive ( ADAS-Cog ) and Clinician 's Interview-Based Impression of Change Plus Caregiver Input global scores in the intention-to-treat population ( N=511 ) , and results were also stratified by apolipoprotein E ( APOE ) genotype ( n=323 ) . No statistically significant differences on primary end points were detected between placebo and any RSG dose . There was a significant interaction between APOE ɛ4 allele status and ADAS-Cog ( P=0.014 ) . Exploratory analyses demonstrated significant improvement in ADAS-Cog in APOE ɛ4-negative patients on 8 mg RSG ( P=0.024 ; not corrected for multiplicity ) . APOE ɛ4-positive patients did not show improvement and showed a decline at the lowest RSG dose ( P=0.012 ; not corrected for multiplicity ) . Exploratory analyses suggested that APOE ɛ4 non-carriers exhibited cognitive and functional improvement in response to RSG , whereas APOE ɛ4 allele carriers showed no improvement and some decline was noted . These preliminary findings require confirmation in appropriate clinical studies 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 Physical activity may help preserve cognitive function and decrease dementia risk , but epidemiologic findings are inconsistent . The authors conducted a prospect i ve study to determine the association between physical activity and risk of dementia , Alzheimer 's disease , and vascular dementia . The US study population comprised 3,375 men and women aged 65 years or older , free of dementia at baseline , who participated in the Cardiovascular Health Cognition Study in 1992 - 2000 . Leisure-time energy expenditure and an activity index reflecting number of different physical activities were calculated . Analyses were based on Cox proportional hazards models . There were 480 incident cases of dementia over an average of 5.4 years of follow-up . After multivariate adjustment , participants in the highest quartile of physical energy expenditure had a relative risk of dementia of 0.85 ( 95 % confidence interval : 0.61 , 1.19 ) compared with those in the lowest quartile , and participants engaging in > or=4 activities had a relative risk of dementia of 0.51 ( 95 % confidence interval : 0.33 , 0.79 ) compared with those engaging in 0 - 1 activity . These associations were more marked in apolipoprotein E genotype ( APOE ) epsilon4 allele noncarriers but were absent in carriers . A similar pattern was observed for Alzheimer 's disease and vascular dementia . Mechanisms to explain the observed relations deserve further study OBJECTIVE To determine acute effects of intranasal insulin on regional cerebral perfusion and cognition in older adults with type 2 diabetes mellitus ( DM ) . RESEARCH DESIGN AND METHODS This was a proof-of-concept , r and omized , double-blind , placebo-controlled intervention evaluating the effects of a single 40-IU dose of insulin or saline on vasoreactivity and cognition in 15 DM and 14 control subjects . Measurements included regional perfusion , vasodilatation to hypercapnia with 3-Tesla MRI , and neuropsychological evaluation . RESULTS Intranasal insulin administration was well tolerated and did not affect systemic glucose levels . No serious adverse events were reported . Across all subjects , intranasal insulin improved visuospatial memory ( P ≤ 0.05 ) . In the DM group , an increase of perfusion after insulin administration was greater in the insular cortex compared with the control group ( P = 0.0003 ) . Cognitive performance after insulin administration was related to regional vasoreactivity . Improvements of visuospatial memory after insulin administration in the DM group ( R2adjusted = 0.44 , P = 0.0098 ) and in the verbal fluency test in the control group ( R2adjusted = 0.64 , P = 0.0087 ) were correlated with vasodilatation in the middle cerebral artery territory . CONCLUSIONS Intranasal insulin administration appears safe , does not affect systemic glucose control , and may provide acute improvements of cognitive function in patients with type 2 DM , potentially through vasoreactivity mechanisms . Intranasal insulin-induced changes in cognitive function may be related to vasodilatation in the anterior brain regions , such as insular cortex that regulates attention-related task performance . Larger studies are warranted to identify long-term effects and predictors of positive cognitive response to intranasal insulin therapy In previous studies , adults with Alzheimer 's disease ( AD ) showed memory enhancement when plasma insulin levels were raised to 85 microU/ml , whereas normal adults ' memory was unchanged . Degree of memory enhancement was also related to apolipoprotein E ( apoE ) genotype status for AD patients . Response differences between normal and AD groups could reflect dose-response differences for insulin . To examine this question , 22 adults with AD and 15 normal adults received five doses of insulin on separate days in counterbalanced order , result ing in five plasma insulin levels ( 10 , 25 , 35 , 85 and 135 microU/ml ) , while plasma glucose levels of ~100 mg/dl were maintained . Cognitive performance and plasma APP levels were measured after 120 min of infusion . Relative to baseline , AD patients who were not apoE- epsilon 4 homozygotes had improved memory at higher insulin levels of 35 and 85 microuU/ml , whereas normal adults and AD patients who were epsilon 4 homozygotes showed improved memory at insulin levels of 25 microU/ml . Normal adults ' memory was also improved at insulin levels of 85 microU/ml . Plasma APP was lowered for adults with AD without the epsilon 4 allele at higher levels ( 85 microU/ml ) than for normal adults and epsilon 4 homozygotes , who showed decreased APP at the 35 microU/ml level . AD patients with a single epsilon 4 allele showed a different pattern of insulin effects on APP than did other subjects . In general , few effects of insulin were seen at the highest dose for any subject group . These results support a role for insulin in normal memory and APP modulation that follows a curvilinear response pattern , and suggest that AD patients who are not epsilon 4 homozygotes have reduced sensitivity to insulin that may interfere with such modulation BACKGROUND Reduced brain insulin signaling and low CSF-to-plasma insulin ratios have been observed in patients with Alzheimer disease ( AD ) . Furthermore , intracerebroventricular or IV insulin administration improve memory , alter evoked potentials , and modulate neurotransmitters , possibly by augmenting low brain levels . After intranasal administration , insulin-like peptides follow extracellular pathways to the brain within 15 minutes . OBJECTIVE We tested the hypothesis that daily intranasal insulin treatment would facilitate cognition in patients with early AD or its prodrome , amnestic mild cognitive impairment ( MCI ) . The proportion of verbal information retained after a delay period was the planned primary outcome measure . Secondary outcome measures included attention , caregiver rating of functional status , and plasma levels of insulin , glucose , beta-amyloid , and cortisol . METHODS Twenty-five participants were r and omly assigned to receive either placebo ( n = 12 ) or 20 IU BID intranasal insulin treatment ( n = 13 ) using an electronic atomizer , and 24 participants completed the study . Participants , caregivers , and all clinical evaluators were blinded to treatment assignment . Cognitive measures and blood were obtained at baseline and after 21 days of treatment . RESULTS Fasting plasma glucose and insulin were unchanged with treatment . The insulin-treated group retained more verbal information after a delay compared with the placebo-assigned group ( p = 0.0374 ) . Insulin-treated subjects also showed improved attention ( p = 0.0108 ) and functional status ( p = 0.0410 ) . Insulin treatment raised fasting plasma concentrations of the short form of the beta-amyloid peptide ( A beta 40 ; p = 0.0471 ) without affecting the longer isoform ( A beta 42 ) , result ing in an increased A beta 40/42 ratio ( p = 0.0207 ) . CONCLUSIONS The results of this pilot study support further investigation of the benefits of intranasal insulin for patients with Alzheimer disease , and suggest that intranasal peptide administration may be a novel approach to the treatment of neurodegenerative disorders Previous studies have suggested an acutely improving effect of insulin on memory function . To study changes in memory associated with a prolonged increase in brain insulin activity in humans , here we used the intranasal route of insulin administration known to provide direct access of the substance to the cerebrospinal fluid compartment . Based on previous results indicating a prevalence of insulin receptors in limbic and hippocampal regions as well as improvements in memory with systemic insulin administration , we expected that intranasal administration of insulin improves primarily hippocampus dependent declaration memory function . Also , improvements in mood were expected . We investigated the effects of 8 weeks of intranasal administration of insulin ( human regular insulin 4 x 40 IU/d ) on declarative memory ( immediate and delayed recall of word lists ) , attention ( Stroop test ) , and mood in 38 healthy subjects ( 24 males ) in a double blind , between-subject comparison . Blood glucose and plasma insulin levels did not differ between the placebo and insulin conditions . Delayed
Output:
| Most studies showed that verbal memory and especially story recall was improved after IN insulin administration .
Sometimes the effect was restricted for apoe4 ( − ) patients .
Intranasal insulin did not affect other cognitive functions .
However , there were some positive results in functional status and daily activity .
Conclusions Intranasal insulin improved story recall performance of apoe4 ( − ) patients with AD or MCI .
Other cognitive functions were not affected , but there were some positive results in functional status and daily activity . |
MS212234 | ***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 the crucial role of teachers in fostering children 's academic learning and social-emotional well-being , addressing teacher stress in the classroom remains a significant challenge in education . The present study reports results from a r and omized controlled pilot trial of a modified Mindfulness-Based Stress Reduction course ( mMBSR ) adapted specifically for teachers . Results suggest the course may be a promising intervention , with participants showing significant reductions in psychological symptoms and burnout , improvements in observer-rated classroom organization and performance on a computer task of affective attentional bias , and increases in self-compassion . In contrast , control group participants showed declines in cortisol functioning over time and marginally significant increases in burnout . Furthermore , changes in mindfulness were correlated in the expected direction with changes across several outcomes ( psychological symptoms , burnout , sustained attention ) in the intervention group . Implication s of these findings for the training and support of teachers are discussed BACKGROUND Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence . Maintenance antidepressants for at least 2 years is the current recommended treatment , but many individuals are interested in alternatives to medication . Mindfulness-based cognitive therapy ( MBCT ) has been shown to reduce risk of relapse or recurrence compared with usual care , but has not yet been compared with maintenance antidepressant treatment in a definitive trial . We aim ed to see whether MBCT with support to taper or discontinue antidepressant treatment ( MBCT-TS ) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months . METHODS In this single-blind , parallel , group r and omised controlled trial ( PREVENT ) , we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants , from primary care general practice s in urban and rural setting s in the UK . Participants were r and omly assigned to either MBCT-TS or maintenance antidepressants ( in a 1:1 ratio ) with a computer-generated r and om number sequence with stratification by centre and symptomatic status . Participants were aware of treatment allocation and research assessors were masked to treatment allocation . The primary outcome was time to relapse or recurrence of depression , with patients followed up at five separate intervals during the 24-month study period . The primary analysis was based on the principle of intention to treat . The trial is registered with Current Controlled Trials , IS RCT N26666654 . FINDINGS Between March 23 , 2010 , and Oct 21 , 2011 , we assessed 2188 participants for eligibility and recruited 424 patients from 95 general practice s. 212 patients were r and omly assigned to MBCT-TS and 212 to maintenance antidepressants . The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months ( hazard ratio 0·89 , 95 % CI 0·67 - 1·18 ; p=0·43 ) , nor did the number of serious adverse events . Five adverse events were reported , including two deaths , in each of the MBCT-TS and maintenance antidepressants groups . No adverse events were attributable to the interventions or the trial . INTERPRETATION We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence . Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence , residual depressive symptoms , and quality of life . FUNDING National Institute for Health Research ( NIHR ) Health Technology Assessment ( HTA ) programme , and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula UNLABELLED RATIONALE , AIMS & OBJECTIVE : Tools for the assessment of the quality of research studies tend to be specific to a particular research design ( e.g. r and omized controlled trials , or qualitative interviews ) . This makes it difficult to assess the quality of a body of research that addresses the same or a similar research question but using different approaches . The aim of this paper is to describe the development and preliminary evaluation of a quality assessment tool that can be applied to a method ologically diverse set of research articles . METHODS The 16-item quality assessment tool ( QATSDD ) was assessed to determine its reliability and validity when used by health services research ers in the disciplines of psychology , sociology and nursing . Qualitative feedback was also gathered from mixed- methods health research ers regarding the comprehension , content , perceived value and usability of the tool . RESULTS Reference to existing widely used quality assessment tools and experts in systematic review confirmed that the components of the tool represented the construct of ' good research technique ' being assessed . Face validity was subsequently established through feedback from a sample of nine health research ers . Inter-rater reliability was established through substantial agreement between three review ers when applying the tool to a set of three research papers ( κ = 71.5 % ) , and good to substantial agreement between their scores at time 1 and after a 6-week interval at time 2 confirmed test-retest reliability . CONCLUSIONS The QATSDD shows good reliability and validity for use in the quality assessment of a diversity of studies , and may be an extremely useful tool for review ers to st and ardize and increase the rigour of their assessment s in review s of the published papers which include qualitative and quantitative work Positive psychology has flourished in the last 5 years . The authors review recent developments in the field , including books , meetings , courses , and conferences . They also discuss the newly created classification of character strengths and virtues , a positive complement to the various editions of the Diagnostic and Statistical Manual of Mental Disorders ( e. g. , American Psychiatric Association , 1994 ) , and present some cross-cultural findings that suggest a surprising ubiquity of strengths and virtues . Finally , the authors focus on psychological interventions that increase individual happiness . In a 6-group , r and om-assignment , placebo-controlled Internet study , the authors tested 5 purported happiness interventions and 1 plausible control exercise . They found that 3 of the interventions lastingly increased happiness and decreased depressive symptoms . Positive interventions can supplement traditional interventions that relieve suffering and may someday be the practical legacy of positive psychology This prospect i ve study with 464 older adolescents ( 14 to 19 years at Time 1 ; 16 to 21 years at Time 2 ) tested the structural paths of influence through which perceived self-efficacy for affect regulation operates in concert with perceived behavioral efficacy in governing diverse spheres of psychosocial functioning . Self-efficacy to regulate positive and negative affect is accompanied by high efficacy to manage one 's academic development , to resist social pressures for antisocial activities , and to engage oneself with empathy in others ' emotional experiences . Perceived self-efficacy for affect regulation essentially operated mediationally through the latter behavioral forms of self-efficacy rather than directly on prosocial behavior , delinquent conduct , and depression . Perceived empathic self-efficacy functioned as a generalized contributor to psychosocial functioning . It was accompanied by prosocial behavior and low involvement in delinquency but increased vulnerability to depression in adolescent females Parents and teachers of children with special needs face unique social-emotional challenges in carrying out their caregiving roles . Stress associated with these roles impacts parents ' and special educators ' health and well-being , as well as the quality of their parenting and teaching . No rigorous studies have assessed whether mindfulness training ( MT ) might be an effective strategy to reduce stress and cultivate well-being and positive caregiving in these adults . This r and omized controlled study assessed the efficacy of a 5-week MT program for parents and educators of children with special needs . Participants receiving MT showed significant reductions in stress and anxiety and increased mindfulness , self-compassion , and personal growth at program completion and at 2 months follow-up in contrast to waiting-list controls . Relational competence also showed significant positive changes , with medium-to-large effect sizes noted on measures of empathic concern and forgiveness . MT significantly influenced caregiving competence specific to teaching . Mindfulness changes at program completion mediated outcomes at follow-up , suggesting its importance in maintaining emotional balance and facilitating well-being in parents and teachers of children with developmental challenges Cultivating Awareness and Resilience in Education ( CARE for Teachers ) is a mindfulness-based professional development program design ed to reduce stress and improve teachers ' performance and classroom learning environments . A r and omized controlled trial examined program efficacy and acceptability among a sample of 50 teachers r and omly assigned to CARE or waitlist control condition . Participants completed a battery of self-report measures at pre- and postintervention to assess the impact of the CARE program on general well-being , efficacy , burnout/time pressure , and mindfulness . Participants in the CARE group completed an evaluation of the program after completing the intervention . ANCOVAs were computed between the CARE group and control group for each outcome , and the pretest scores served as a covariate . Participation in the CARE program result ed in significant improvements in teacher well-being , efficacy , burnout/time-related stress , and mindfulness compared with controls . Evaluation data showed that teachers viewed CARE as a feasible , acceptable , and effective method for reducing stress and improving performance . Results suggest that the CARE program has promise to support teachers working in challenging setting s and consequently improve classroom environments
Output:
| MBIs showed strongest promise for intermediary effects on teacher emotion regulation .
The results of the review are discussed in the context of a model of teacher stress .
Teacher social and emotional competence has implication s for pupil wellbeing through teacher – pupil relationships and effective management of the classroom . |
MS212235 | ***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 To improve survival of elderly patients with primary central nervous system lymphoma ( PCNSL ) , we conducted a phase II study with high-dose methotrexate ( MTX ) combined with procarbazine and CCNU . To reduce neurotoxicity , whole-brain irradiation was reserved for patients not responding to chemotherapy . PATIENTS AND METHODS High-dose MTX was applied on days 1 , 15 , and 30 , procarbazine on days 1 - 10 , and CCNU on day 1 . Study treatment comprised up to three 45-day cycles . There was no lower limit of Karnofsky performance status ( KPS ) . RESULTS Thirty patients with PCNSL ( n = 29 ) or primary ocular lymphoma ( n = 1 ) were included ( median age 70 years , range 57 - 79 years ) . The median initial KPS was 60 % ( range 30%-90 % ) . Best documented response in 27 assessable patients were 12 of 27 ( 44.4 % ) complete remissions , 7 of 27 ( 25.9 % ) partial remissions , and 8 of 27 ( 29.6 % ) disease progressions . Two patients died of probable treatment-related causes . With a median follow-up of 78 months ( range 34 - 105 ) , the 5-year overall survival is 33 % . Eight of 30 patients ( 26.7 % ) are currently alive and well , six without signs of leukoencephalopathy . CONCLUSION The combination of high-dose MTX with procarbazine and CCNU is feasible and effective and results in a low rate of leukoencephalopathy . Comorbidity and toxicity remain of concern when treating PCNSL in elderly patients BACKGROUND Cyclophosphamide , doxorubicin , vincristine , and prednisolone ( CHOP ) is used to treat patients with non-Hodgkin lymphoma . Interval decrease from 3 weeks of treatment ( CHOP-21 ) to 2 weeks ( CHOP-14 ) , and addition of rituximab to CHOP-21 ( R-CHOP-21 ) has been shown to improve outcome in elderly patients with diffuse large B-cell lymphoma ( DLBCL ) . This r and omised trial assessed whether six or eight cycles of R-CHOP-14 can improve outcome of these patients compared with six or eight cycles of CHOP-14 . METHODS 1222 elderly patients ( aged 61 - 80 years ) were r and omly assigned to six or eight cycles of CHOP-14 with or without rituximab . Radiotherapy was planned to sites of initial bulky disease with or without extranodal involvement . The primary endpoint was event-free survival ; secondary endpoints were response , progression during treatment , progression-free survival , overall survival , and frequency of toxic effects . Analyses were done by intention to treat . The trial is registered on National Cancer Institute website , number NCT00052936 and as EU-20243 . FINDINGS 3-year event-free survival was 47.2 % after six cycles of CHOP-14 ( 95 % CI 41.2 - 53.3 ) , 53.0 % ( 47.0 - 59.1 ) after eight cycles of CHOP-14 , 66.5 % ( 60.9 - 72.0 ) after six cycles of R-CHOP-14 , and 63.1 % ( 57.4 - 68.8 ) after eight cycles of R-CHOP-14 . Compared with six cycles of CHOP-14 , the improvement in 3-year event-free survival was 5.8 % ( -2.8 - 14.4 ) for eight cycles of CHOP-14 , 19.3 % ( 11.1 - 27.5 ) for six cycles of R-CHOP-14 , and 15.9 % ( 7.6 - 24.2 ) for eight cycles of R-CHOP-14 . 3-year overall survival was 67.7 % ( 62.0 - 73.5 ) for six cycles of CHOP-14 , 66.0 % ( 60.1 - 71.9 ) for eight cycles of CHOP-14 , 78.1 % ( 73.2 - 83.0 ) for six cycles of R-CHOP-14 , and 72.5 % ( 67.1 - 77.9 ) for eight cycles of R-CHOP-14 . Compared with treatment with six cycles of CHOP-14 , overall survival improved by -1.7 % ( -10.0 - 6.6 ) after eight cycles of CHOP-14 , 10.4 % ( 2.8 - 18.0 ) after six cycles of R-CHOP-14 , and 4.8 % ( -3.1 - 12.7 ) after eight cycles of R-CHOP-14 . In a multivariate analysis that used six cycles of CHOP-14 without rituximab as the reference , and adjusting for known prognostic factors , all three intensified regimens improved 3-year event-free survival ( eight cycles of CHOP-14 : RR [ relative risk ] 0.76 [ 0.60 - 0.95 ] , p=0.0172 ; six cycles of R-CHOP-14 : RR 0.51 [ 0.40 - 0.65 ] , p<0.0001 ; eight cycles of R-CHOP-14 : RR 0.54 [ 0.43 - 0.69 ] , p<0.0001 ) . Progression-free survival improved after six cycles of R-CHOP-14 ( RR 0.50 [ 0.38 - 0.67 ] , p<0.0001 ) , and eight cycles of R-CHOP-14 ( RR 0.59 [ 0.45 - 0.77 ] , p=0.0001 ) . Overall survival improved only after six cycles of R-CHOP-14 ( RR 0.63 [ 0.46 - 0.85 ] , p=0.0031 ) . In patients with a partial response after four cycles of chemotherapy , eight cycles were not better than six cycles . INTERPRETATION Six cycles of R-CHOP-14 significantly improved event-free , progression-free , and overall survival over six cycles of CHOP-14 treatment . Response-adapted addition of chemotherapy beyond six cycles , though widely practice d , is not justified . Of the four regimens assessed in this study , six cycles of R-CHOP-14 is the preferred treatment for elderly patients , with which other approaches should be compared 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 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 The Nordic Lymphoma Group has conducted a phase ll trial in newly diagnosed primary central nervous system lymphoma patients applying an age-adjusted multi-agent immunochemotherapy regimen , which in elderly patients included temozolomide maintenance treatment . Patients aged 18–75 years were eligible . Thirty-nine patients aged 18–65 years and 27 patients aged 66–75 years were enrolled . The median age of the two age groups was 55 and 70 years , respectively . The overall response rate was 73.8 % for the entire cohort : 69.9 % in the younger and 80.8 % in the elderly subgroup . With a median follow up of 22 months , the 2-year overall survival probability was 60.7 % in patients aged 65 years or under and 55.6 % in patients aged over 65 years ( P=0.40 ) . The estimated progression-free survival at two years was 33.1 % ( 95%CI : 19.1%–47.9 % ) in patients aged under 65 years and 44.4 % ( 95%CI : 25.6%–61.8 % ) in the elderly subgroup ( P=0.74 ) . Median duration
Output:
| Elderly PCNSL patients benefit from HD-MTX-based therapy , especially if combined with oral alkylating agents .
More aggressive HD-MTX protocol s do not seem to improve outcome .
WBRT may improve outcome , but is associated with increased risk for neurological side-effects . |
MS212236 | ***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: Recent evidence suggests that dietary fat intake may be more strongly associated than total energy intake to the development and maintenance of obesity . The objective of this study was to determine whether dietary fat restriction would promote more favorable changes in body weight , body composition , resting metabolic rate ( RMR ) , eating behavior , and dietary adherence than calorie restriction . Sixty-five obese women and 15 obese men were recruited and r and omly assigned to calorie restriction ( 1000–1200 kcal/day ) or fat restriction ( 22–26 g/day ) . Subjects participated in a 24-week behavioral weight loss program . Fortyeight subjects completed assessment s at all four time points — baseline and 6 , 12 , and 18 months . Weight loss was significantly greater in the low calorie ( LC ) group ( −11.2 versus −6.1 kg , p<.001 ) and was maintained better at the 18-month assessment ( −7.5 versus −1.8 kg , p≤.001 ) . There was a significantly greater decrease in percent body fat and RMR for the LC group with only percent body fat still significantly lower at 18 months . Subjects in the LC group consumed significantly fewer calories , less carbohydrates , and the same amount of fat as those in the low fat ( LF ) condition , however , calorie and carbohydrate intake were decreasing for LF subjects by the 12- and 18-month assessment s. There were no long-term differences in most measured predictors of dietary adherence . Dietary fat restriction did not prove to be superior to calorie restriction , thus strengthening the public health message that calories do count The role of dietary fat in the regulation of energy intake was assessed by manipulating a conventional diet and measuring spontaneous food consumption . Twenty-four women each consumed a sequence of three 2-wk dietary treatments in which 15 - 20 % , 30 - 35 % , or 45 - 50 % of the energy was derived from fat . These diets consisted of foods that were similar in appearance and palatability but differed in the amount of high-fat ingredients used . Relative to their energy consumption on the medium-fat diet , the subjects spontaneously consumed an 11.3 % deficit on the low-fat diet and a 15.4 % surfeit on the high-fat diet ( p less than 0.0001 ) , result ing in significant changes in body weight ( p less than 0.001 ) . A small amount of caloric compensation did occur ( p less than 0.02 ) , which was greatest in the leanest subjects ( p less than 0.03 ) . These results suggest that habitual , unrestricted consumption of low-fat diets may be an effective approach to weight control In a prospect i ve , r and omised , controlled trial to determine whether comprehensive lifestyle changes affect coronary atherosclerosis after 1 year , 28 patients were assigned to an experimental group ( low-fat vegetarian diet , stopping smoking , stress management training , and moderate exercise ) and 20 to a usual-care control group . 195 coronary artery lesions were analysed by quantitative coronary angiography . The average percentage diameter stenosis regressed from 40.0 ( SD 16.9)% to 37.8 (16.5)% in the experimental group yet progressed from 42.7 (15.5)% to 46.1 (18.5)% in the control group . When only lesions greater than 50 % stenosed were analysed , the average percentage diameter stenosis regressed from 61.1 (8.8)% to 55.8 (11.0)% in the experimental group and progressed from 61.7 (9.5)% to 64.4 (16.3)% in the control group . Overall , 82 % of experimental-group patients had an average change towards regression . Comprehensive lifestyle changes may be able to bring about regression of even severe coronary atherosclerosis after only 1 year , without use of lipid-lowering drugs This r and omised controlled trial examined anthropometric changes and cardiovascular benefits of six months of weight management in 110 free living women , aged 18–68 y and BMI 25–50 kg/m2 , who received 1200 kcal/d diet treatments of either high ( 58 % energy , n=57 ) or low ( 35 % energy , n=53 ) carbohydrate ( CHO ) content . Body weight , plasma total , HDL and LDL cholesterol , triglyceride and blood pressure were measured . Examination at three months showed women on high CHO lost ( mean±s.e.m . ) 4.3±0.5 kg and those on low CHO lost 5.6±0.6 kg of body weight . Changes in risk factors did not significantly differ between the two diet treatments throughout the study . However those on high CHO diets significantly lowered their plasma total cholesterol by 0.33 mmol/l ( 95 % CI : 0.10 , 0.55 ) , LDL cholesterol by 0.23 mmol/l ( 0.02 , 0.43 ) and HDL cholesterol by 0.05 mmol/l ( 0.03 , 0.10 ) , while women on low CHO diets lowered only plasma triglyceride by 0.28 mmol/l ( 0.08 , 0.48 ) . Blood pressure did not change significantly on either diet . After six months , women on high CHO lost 5.6±0.8 kg and those on low CHO lost 6.8±0.8 kg . On the high CHO diet , total cholesterol remained significantly below the baseline value at 0.34 mmol/l ( 0.13 , 0.56 ) , triglyceride was significantly lowered by 0.27 mmol/l ( 0.10 , 0.45 ) , and HDL cholesterol returned to the baseline value . On the low CHO diet , triglyceride remained the only risk factor to be significantly improved . A subgroup of 46 postmenopausal women lost significantly ( P<0.05 ) more weight on the low CHO diet than high CHO diet . In conclusion , these results provided some support for preferring a high CHO diet to a lower CHO approach in weight management , from the point of view of risk reduction , but do not indicate a consistently more rapid weight loss with either diet OBJECTIVE The aim of this r and omized trial was to compare the effects of a behavioral intervention focusing on either calorie restriction alone or calorie plus fat restriction on weight loss and changes in lipids and glycemic control in individuals with non-insulin-dependent diabetes mellitus ( NIDDM ) or a family history of diabetes . RESEARCH DESIGN AND METHODS We recruited 44 obese women with NIDDM and 46 obese women with a family history of NIDDM and r and omly assigned these subjects to calorie restriction ( CAL ) or to calorie plus fat restriction ( CAL + FAT ) . All subjects participated in a 16-week behavioral weight loss program , with training in diet , exercise , and behavior modification . Subjects assigned to the CAL condition were given a 1,000−1,500 kcal/day goal and self-monitored calories consumed . Subjects assigned to the CAL + FAT condition had the same calorie goal , but were also given a fat goal ( grams of fat/day ) , to produce a diet with < 20 % of calories from fat ; this group monitored both calories and fat grams . RESULTS Among NIDDM subjects , weight loss of the subjects in the CAL+FAT condition was significantly > subjects in the CAL condition ( 7.7 vs. 4.6 kg ) and the CAL+FAT condition group also maintained their weight loss better at the 1-year follow-up ( 5.2 vs. 1.0 kg ) . Significant decreases in glucose , high-density lipoprotein ( HDL ) cholesterol , and total cholesterol were seen after 16 weeks of treatment among NIDDM subjects ; these changes were similar in CAL and CAL+FAT groups , but a greater proportion of subjects in CAL condition required oral hypoglycemic medication . At the 1-year follow-up , all parameters had returned to baseline . No significant differences in weight loss or physiological changes were seen between CAL and CAL+FAT conditions in subjects with a family history of diabetes . CONCLUSIONS These results suggest that using the combination of calorie and fat restriction may help promote weight loss in obese NIDDM patients . No other long-term benefits of this regimen were observed OBJECTIVE : We investigated the prevalence of overweight and obesity and their relationships with the main cardiovascular risk factors in the population of Ventimiglia di Sicilia , a rural village in Southern Italy characterized by low cholesterol levels and by a low incidence of early coronary heart disease mortality . We related all deaths to body weight and fat distribution during an 8 y follow-up . DESIGN : Cross-sectional and prospect i ve observational study .SUBJECTS : A total of 835 free-living individuals , 363 males and 472 females , of age between 20 and 69 y. MEASUREMENTS : In all participants body weight , waist-to-hip ratio ( WHR ) , cardiovascular risk factors and plasma lipids were measured . During the follow-up , total and cardiovascular deaths were registered . RESULTS : We found a high overall prevalence of subjects with overweight or obesity ( respectively 45.0 % and 27.7 % ) , with great differences among classes of age . As expected , body weight and fat distribution were associated with diabetes , hypertension , dyslipidemia and with a worsening of lipid profile . During the follow-up we registered 37 total and 11 cardiovascular deaths . All-cause and cardiovascular mortality risks were , respectively , 1.64 ( 95 % CI 0.65–4.15 ) and 2.71 ( 95 % CI 0.29–25.26 ) in subjects with a body mass index ( BMI ) of 27–29.99 kg/m2 and 2.45 ( 95 % CI 1.03–5.87 ) and 5.36 ( 95 % CI 1.41–62.01 ) in subjects with a BMI of≥30 kg/m2 in comparison with participants with a BMI of < 27 kg/m2 , and 3.48 ( 95 % CI 1.46–8.30 ) and 4.55 ( 95 % CI 1.12–18.40 ) in subjects with a WHR higher than the median in comparison with individuals with a WHR lower than the median . CONCLUSION : The Ventimiglia di Sicilia Study highlights the great importance of overweight and obesity as a public health issue in a rural population and indicates that it is necessary to consider the impact of body weight and fat distribution on both total and CHD mortality Quantification of the excess mortality from all causes associated with obesity remains controversial . In this paper , 6,193 obese patients , those with a body mass index ( weight (kg)/height (m)2 ( BMI ) ) range of 25 - 74 kg/m2 , recruited from 1961 to 1994 in Düsseldorf , Germany , were followed for a mean time of 14 ( st and ard deviation , 8.2 ) years , yielding 87,179 observed patient-years . During the study period , 1,028 patients ( 16.6 % ) died . The entire cohort was grouped into approximate quartiles according to BMI : group 1 , BMI from 25 to < 32 ; group 2 , BMI from 32 to < 36 ; group 3 , BMI from 36 to < 40 ; group 4 , BMI > or = 40 kg/m2 . The following risk ratios were estimated by means of Cox proportional hazards models using the lowest BMI group as reference category : group 2 for men , 1.02 ( 95 % confidence interval 0.76 - 1.37 ) ; for women , 1.23 ( 95 % confidence interval 0.96 - 1.58 ) ; group 3 for men , 1.50 ( 95 % confidence interval 1.09 - 2.06 ) ; for women , 1.33 ( 95 % confidence interval 1.03 - 1.73 ) ; and group 4 for men , 2.10 ( 95 % confidence interval 1.53 - 2.88 ) ; for women , 2.25 ( 95 % confidence interval 1.78 - 2.84 ) . The following st and ardized mortality ratios were calculated by using the respective geographic area ( the Federal State of North Rhine Westphalia ) as reference population : group 1 for men , 1.26 ( 95 % confidence interval 0.98 - 1.61 ) ; for women , 1.00 ( 95 % confidence interval 0.81 - 1.23 ) ; group 2 for men , 1.31 ( 95 % confidence interval 1.09 - 1.57 ) ; for women , 1.20 ( 95 % confidence interval 1.02 - 1.40 ) ; group 3 for men , 1.92 ( 95 % confidence interval 1.53 - 2.38 ) ; for women , 1.27 ( 95 % confidence interval 1.07 - 1.50 ) ; and group 4 for men , 3.05 ( 95 % confidence interval 2.47 - 3.73 ) ; for women , 2.31 ( 95 % confidence interval
Output:
| Apart from one study which showed a slight but statistically significant difference in total cholesterol in the low fat group at one year follow-up , there were no significant differences between the dietary groups for other outcome measures such as serum lipids , blood pressure and fasting plasma glucose .
REVIEW ER 'S CONCLUSIONS The review suggests that fat-restricted diets are no better than calorie restricted diets in achieving long term weight loss in overweight or obese people .
Overall , participants lost slightly more weight on the control diets but this was not significantly different from the weight loss achieved through dietary fat restriction and was so small as to be clinical ly insignificant |
MS212237 | ***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 Dementia due to Alzheimer ’s disease ( AD ) and dementia with Lewy bodies ( DLB ) are the two most common neurodegenerative causes of dementia . They commonly occur together , especially in older people , but clinical identification of these diseases in dementia is difficult in such circumstances . We therefore conducted a study using cases with both comprehensive prospect i ve clinical assessment s and complete neuropathological examination to determine if it is possible to identify such mixed cases clinical ly and to determine features which may identify DLB in the presence of AD dementia . Methods At Newcastle Brain Bank we identified subjects who had a clinical diagnosis of dementia and who also had autopsy diagnoses of pure AD , pure DLB , or mixed AD+DLB . All subjects had undergone prospect i ve longitudinal clinical assessment s. Mixed AD+DLB patients met neuropathological criteria for both DLB ( limbic/neocortical Lewy body disease ) and AD ( Braak stage V/VI and CERAD B/C ) . The records of these subjects were carefully review ed by two specialists in old-age psychiatry blind to autopsy findings to determine baseline and final clinical diagnoses based on these detailed records . The presence of characteristic Lewy body symptoms and other clinical information was also recorded . Results Of 59 subjects included , 19 were AD , 18 DLB , and 22 mixed AD+DLB . At baseline no subjects were correctly identified as having mixed AD+DLB and by final diagnosis only 23 % were identified . The only symptom which helped in identifying the presence of Lewy body disease in the context of a mixed AD+DLB dementia was complex visual hallucinations . Conclusions Whilst the identification of DLB in the context of a dementia with an AD pattern is difficult , the emergence of complex visual hallucinations in the context of such a degenerative dementia suggests the presence of Lewy body disease and should encourage a careful assessment . Biomarkers appear likely to be necessary to help improve identification of different disease subtypes underlying dementia Background Falls are a major cause of morbidity and mortality in dementia , but there have been no prospect i ve studies of risk factors for falling specific to this patient population , and no successful falls intervention/prevention trials . This prospect i ve study aim ed to identify modifiable risk factors for falling in older people with mild to moderate dementia . Methods and Findings 179 participants aged over 65 years were recruited from outpatient clinics in the UK ( 38 Alzheimer 's disease ( AD ) , 32 Vascular dementia ( VAD ) , 30 Dementia with Lewy bodies ( DLB ) , 40 Parkinson 's disease with dementia ( PDD ) , 39 healthy controls ) . A multifactorial assessment of baseline risk factors was performed and fall diaries were completed prospect ively for 12 months . Dementia participants experienced nearly 8 times more incident falls ( 9118/1000 person-years ) than controls ( 1023/1000 person-years ; incidence density ratio : 7.58 , 3.11–18.5 ) . In dementia , significant univariate predictors of sustaining at least one fall included diagnosis of Lewy body disorder ( proportional hazard ratio ( HR ) adjusted for age and sex : 3.33 , 2.11–5.26 ) , and history of falls in the preceding 12 months ( HR : 2.52 , 1.52–4.17 ) . In multivariate analyses , significant potentially modifiable predictors were symptomatic orthostatic hypotension ( HR : 2.13 , 1.19–3.80 ) , autonomic symptom score ( HR per point 0–36 : 1.055 , 1.012–1.099 ) , and Cornell depression score ( HR per point 0–40 : 1.053 , 1.01–1.099 ) . Higher levels of physical activity were protective ( HR per point 0–9 : 0.827 , 0.716–0.956 ) . Conclusions The management of symptomatic orthostatic hypotension , autonomic symptoms and depression , and the encouragement of physical activity may provide the core elements for the most fruitful strategy to reduce falls in people with dementia . R and omised controlled trials to assess such a strategy are a priority Auteur(s ) : Jacques Boddaert , Marc Verny La responsabilite de la maladie d’Alzheimer ( MA ) dans les gr and es causes de mortalite a ete suggeree par differentes etudes , et differents facteurs pejoratifs ont ete rapportes , tels que le sexe masculin , la severite initiale de la maladie , l’existence de troubles du comportement , de deambulation ou de chutes , et la presence de signes extrapyramidaux . Les donnees de la litterature sont assez variables , selon que l’on parle de debut de la maladie , et dans ce cas selon les criteres que l’on retient pour le definir , ou de date du diagnostic . De meme , l’evolutivite du declin cognitif doit etre prise en compte , comme le confirme l’etude de Hui et al. sur 354 patients avec une MA suivis sur une periode 4 ans [ 1 ] . Degre de complexite supplementaire chez le gr and vieillard polypathologique , les nombreuses comorbidites associees jouent probablement un role determinant dans la survie de ces patients , et parler de survie de la MA dem and e une prise en compte de tous ces parametres confondants . Wolfson et al. , a partir de la Canadian study of health and aging ( CSHA ) , avaient etudie la survie de la MA en 2001 en considerant le debut de la maladie d’Alzheimer diagnostique par 3 questions de la Camdex ( Cambridge examination for mental disorders of the elderly ) . Ces auteurs avaient rapporte une mediane de survie de 3,1 ans chez des patients âges ( 83 + /- 7 ans ) avec MA , en utilisant des ajustements pour le biais de duree d’evolution , le sexe , le niveau d’education et l’âge au moment du diagnostic , qui restait , apres regression logistique , le facteur de plus mauvais pronostic [ 2 ] . Recemment , Larson et al. ont publie de nouveaux result ats sur le sujet [ 3 ] . Il s’agit d’une etude observationnelle prospect i ve , a partir de 23 000 patients âges de 60 ans ou plus engages dans un programme de sante , suivis de 1987 a 1996 , permettant d’etudier l’histoire naturelle de la MA dans les cas incidents . Durant la periode de l’etude , 970 patients ont ete explores pour un syndrome dementiel . Parmi eux , 521 nouveaux cas de MA ont ete diagnostiques , comprenant 431 cas probables et 90 cas de MA possible selon les criteres du DSM-III-R et NINCDS-ADRDA , avec un suivi moyen de 5,2 ± 3,1 ans . Les scores au MMS au moment du diagnostic se repartissaient en 17 % entre 25 et 30 , 24 % entre 22 et 24 , 30 % entre 18 et 21 et 30 % ≤ 17 . Les scores relativement bas de MMS ( 60 % ≤ 21 ) sont dus aux modes de recrutement ( patients entrant dans le registre s’ils recevaient des soins ) et a ceux du reperage des symptomes de demence ( troubles mnesiques , confusion ou deambulation ... ) . La mediane de survie des patients a partir du diagnostic de la maladie etait influencee par de nombreux facteurs . Elle passait de 4,2 ans pour les hommes a 5,7 ans pour les femmes , confirmant le caractere pejoratif du sexe masculin . Concernant les comorbidites , cette etude soulignait le role d’une cardiopathie ischemique ( p < 0,001 ) , d’une insuffisance cardiaque ( p < 0,001 ) , du diabete ( p = 0,04 ) et d’un antecedent d’accident vasculaire cerebral ( p = 0,026 ) associes . Par contre , l’hypertension arterielle , consideree comme representant un facteur de declin de la MA , n’influencait pas la maladie . En analyse multivariee , ajustee pour l’âge , le sexe , l’origine ethnique , l’existence d’une cardiopathie ischemique , d’une insuffisance cardiaque et d’un diabete , le deces etait correle : 1 ) au score MMSE au moment du diagnostic ( ≤ 17 : hazard ratio 2,67 [ 1,94 - 3,66 ] , p < 0,001 ) ; 2 ) au score DRS ( entre 5,5 et 17 : hazard ratio 2,04 [ 1,54 - 2,71 , p < 0,001 ) ; 3 ) aux signes frontaux ( hazard ratio 1,27 [ 1,03 - 1,55 ] , p = 0,022 ) ; 4 ) aux signes extrapyramidaux ( hazard ratio 1,35 [ 1,03 - 1,76 ] , p = 0,028 ) ; 5 ) aux troubles de l’humeur ( hazard ratio 1,4 [ 1,12 - 1,76 ] , p = 0,004 ) , 6/ a la deambulation ( hazard ratio 1,45 [ 1,02 - 2,08 ] , p = 0,04 ) . Le declin de plus de 5 points de MMS par an etait egalement associe a une mortalite augmentee . En comparant les result ats de l’etude aux donnees de la mortalite dans la population des Etats-Unis , les patients atteints d’une MA avaient constamment une reduction de l’esperance de vie . Les causes de deces ne sont pas rapportees . La correlation inverse entre mortalite et score au MMS reflete probablement la duree d’evolution de la maladie et l’on peut s’interroger sur l’impact d’une prise en charge globale et plus encore medicamenteuse chez ces patients . Cette etude souligne l ’ importance des comorbidites dans la MA du sujet âge , et est utile pour le clinicien , en particulier pour decider de la mise en place de therapeutiques lourdes . De plus , la mise en evidence de facteurs pejoratifs associes permet de cibler une population plus a risque et d’adapter au mieux surveillance et traitements . La limitation principale de cette etude concerne le mode de recrutement et le caractere non representatif de la population dans son ensemble . De nouvelles etudes , idealement en population , devront preciser la duree de vie des malades atteints d’une maladie d’Alzheimer et evaluer l’impact sur la survie des therapeutiques symptomatiques de la MA ou des traitements des comorbidites . 1 . Hui JS , Wilson RS , Bennett DA , Bienias JL , Gilley DW , Evans DA . Rate of cognitive decline and mortality in Alzheimer ’s disease . Neurology 2003 ; 61 : 1356 - 61 . 2 . Wolfson C , Wolfson DB , Asgharian M , M’Lan CE , Ostbye T , Rockwood K , et al. Clinical Progression of Dementia Study Group . A reevaluation of the duration of survival after the onset of dementia . N Engl J Med 2001 ; 344 : 1111- 6 . 3 . Larson EB , Shadlen MF , Wang L , McCormick WC , Bowen JD , Teri L , et al. Survival after initial diagnosis of Alzheimer disease . Ann Intern Med 2004 ; 140 : 501 - 9 Introduction Autonomic dysfunction is a well-known feature in neurodegenerative dementias , especially common in α-synucleinopathies like dementia with Lewy bodies and Parkinson 's disease with dementia . The most common symptoms are orthostatic hypotension , incontinence and constipation , but its relevance in clinical practice is poorly understood . There are no earlier studies addressing the influence of autonomic dysfunction on clinical course and survival . The aim of this study was to investigate the frequency of the three most common features of autonomic dysfunction and analyze how it affects survival . Methods Thirty patients with dementia with Lewy bodies and Parkinson 's disease with dementia were included in this prospect i ve , longitudinal follow-up study . Presence of incontinence and constipation was recorded at baseline . Blood pressure was measured at baseline , after 3 months and after 6 months according to st and ardized procedures , with 5 measurements during 10 minutes after rising . Orthostatic hypotension was defined using consensus definitions and persistent orthostatic hypotension was defined as 5 or more measurements with orthostatic hypotension . Difference in survival was analyzed 36 months after baseline . Results There was a high frequency of persistent orthostatic blood pressure ( 50 % ) , constipation ( 30 % ) and incontinence ( 30 % ) . Patients with persistent orthostatic hypotension had a significantly shorter survival compared to those with no or non-persistent orthostatic hypotension ( Log rank x2 = 4.47 , p = 0.034 ) . Patients with constipation and /or urinary incontinence , in addition to persistent orthostatic hypotension , had a poorer prognosis compared to those with isolated persistent orthostatic hypotension or no orthostatic hypotension ( Log rank x
Output:
| Differences in survival were not explained by follow-up time , age at diagnosis , gender , or cognitive score .
There is consistent evidence for higher and earlier mortality in DLB compared to AD . |
MS212238 | ***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-quarter of neonatal deaths are attributed to infections . Maternal h and washing with soap may prevent neonatal sepsis . We examined impact of intensive h and washing promotion on h and washing behavior of mothers of neonates . In Matlab , Bangladesh , we r and omly allocated pregnant women at 28–32 weeks ' gestation to intensive h and washing promotion or control . Behavior change communicators used a participatory approach to motivate maternal h and washing with soap and provided soap and h and washing stations . In the neonatal period , we observed soap and water at h and washing places and , at the end of the neonatal period , we estimated impact on maternal h and washing by structured observation . Among 253 women enrolled , intervention households were between 5.7 and 15.2 times as likely as control households to have soap and water present at the h and washing station in the baby 's sleeping area . Intervention mothers washed h and s with soap 4.1 times as frequently as controls ( 95 % CI 2.55–6.59 ) ; h and washing with soap at recommended times was infrequent in both intervention ( 9 % ) and control ( 2 % ) groups . Intensively promoting h and washing with soap result ed in increased availability of soap and water at h and washing places , but only a modest increase in maternal h and washing with soap . Novel approaches to motivating h and washing behavior to protect newborns should be developed and evaluated BACKGROUND Effective prevention and control of diarrhoea requires caregivers to comply with a suite of proven measures , including exclusive breastfeeding , h and washing with soap , correct use of oral rehydration salts , and zinc administration . We aim ed to assess the effect of a novel behaviour change intervention using emotional drivers on caregiver practice of these behaviours . METHODS We did a cluster r and omised controlled trial in Lusaka Province , Zambia . A r and om sample of 16 health centres ( clusters ) were selected from a sampling frame of 81 health centres in three of four districts in Lusaka Province using a computerised r and om number generator . Each cluster was r and omly assigned 1:1 to either the intervention-clinic events , community events , and radio messaging-or to a st and ard care control arm , both for 6 months . Primary outcomes were exclusive breastfeeding ( self-report ) , h and washing with soap ( observation ) , oral rehydration salt solution preparation ( demonstration ) , and zinc use in diarrhoea treatment ( self-report ) . We measured outcome behaviours at baseline before start of intervention and 4 - 6 weeks post-intervention through repeat cross-sectional surveys with mothers of an infant younger than 6 months and primary caregivers of a child younger than 5 years with recent diarrhoea . We compared outcomes on an intention-to-treat population between intervention and control groups adjusted for baseline behaviour . The study was registered with Clinical Trials.gov , number NCT02081521 . FINDINGS Between Jan 20 and Feb 3 , 2014 , we recruited 306 mothers of an infant aged 0 - 5 months ( 156 intervention , 150 st and ard care ) and 343 primary caregiver of a child aged 0 - 59 months with recent diarrhoea ( 176 intervention , 167 st and ard care ) at baseline . Between Oct 20 to Nov 7 , 2014 , we recruited 401 mothers of an infant 0 - 5 months ( 234 intervention , 167 st and ard care ) and 410 primary caregivers of a child 0 - 59 months with recent diarrhoea ( 257 intervention , 163 st and ard care ) at endline . Intervention was associated with increased prevalence of self-reported exclusive breastfeeding of infants aged 0 - 5 months ( adjusted difference 10·5 % , 95 % CI 0·9 - 19·9 ) . Other primary outcomes were not affected by intervention . Cluster intervention exposure ranged from 11 - 81 % , measured by participant self-report with verification questions . Comparison of control and intervention clusters with coverage greater than 35 % provided strong evidence of an intervention effect on oral rehydration salt solution preparation and breastfeeding outcomes . INTERPRETATION The intervention may have improved exclusive breastfeeding ( assessed by self-reporting ) , but intervention effects were diluted in clusters with low exposure . Complex caregiver practice s can improve through interventions built around human motives , but these must be implemented more intensely . FUNDING Absolute Return for Kids ( ARK ) and Comic Relief Background H and washing is a cost-effective way of preventing communicable diseases such as respiratory and food-borne illnesses . However , h and washing rates are low in developing countries . Target 7C of the seventh Millennium Development Goals was to increase by half the proportion of people with sustainable access to safe drinking water and basic sanitation by 2015 . Studies have found that better access to improved water sources and sanitation is associated with higher rates of h and washing . Objective Our goal was to describe h and washing behaviour and identify the associated factors in Vietnamese households . Design Data from 12,000 households participating in the Vietnam Multiple Indicator Cluster Survey 2011 were used . The survey used a multistage sampling method to r and omly select 100 clusters and 20 households per cluster . Self-administered question naires were used to collect data from a household representative . Demographic variables , the presence of a specific place for h and washing , soap and water , access to improved sanitation , and access to improved water sources were tested for association with h and washing behaviour in logistic regression . Results Almost 98 % of households had a specific place for h and washing , and 85 % had cleansing material s and water at such a place . The prevalence of h and washing in the sample was almost 85 % . Educational level , ethnicity of the household head , and household wealth were factors associated with h and washing practice ( p<0.05 ) . Those having access to an improved sanitation facility were more likely to practise h and washing [ odds ratio (OR)=1.69 , 95 % confidence interval ( CI ) : 1.37–2.09 , p<0.001 ] , as were those with access to improved water sources ( OR=1.74 , 95 % CI : 1.37–2.21 , p<0.001 ) . Conclusions Households with low education , low wealth , belonging to ethnic minorities , and with low access to improved sanitation facilities and water sources should be targeted for interventions implementing h and washing practice . In addition , the availability of soap and water at h and washing sites should be increased and practical teaching programs should be deployed in order to increase h and washing rates BACKGROUND Diarrhoea and respiratory infections are the two biggest causes of child death globally . H and washing with soap could substantially reduce diarrhoea and respiratory infections , but prevalence of adequate h and washing is low . We tested whether a scalable village-level intervention based on emotional drivers of behaviour , rather than knowledge , could improve h and washing behaviour in rural India . METHODS The study was done in Chittoor district in southern And hra Pradesh , India , between May 24 , 2011 , and Sept 10 , 2012 . Eligible villages had a population of 700 - 2000 people , a state-run primary school for children aged 8 - 13 years , and a preschool for children younger than 5 years . 14 villages ( clusters ) were selected , stratified by population size ( < 1200 vs > 1200 ) , and r and omly assigned in a 1:1 ratio to intervention or control ( no intervention ) . Clusters were enrolled by the study manager . R and om allocation was done by the study statistician using a r and om number generator . The intervention included community and school-based events incorporating an animated film , skits , and public pledging ceremonies . Outcomes were measured by direct observation in 20 - 25 households per village at baseline and at three follow-up visits ( 6 weeks , 6 months , and 12 months after the intervention ) . Observers had no connection with the intervention and observers and participant households were told that the study was about domestic water use to reduce the risk of bias . No other masking was possible . The primary outcome was the proportion of h and washing with soap at key events ( after defecation , after cleaning a child 's bottom , before food preparation , and before eating ) at all follow-up visits . The control villages received a shortened version of the intervention before the final follow-up round . Outcome data are presented as village-level means . FINDINGS H and washing with soap at key events was rare at baseline in both the intervention and control groups ( 1 % [ SD 1 ] vs 2 % [ 1 ] ) . At 6 weeks ' follow-up , h and washing with soap at key events was more common in the intervention group than in the control group ( 19 % [ SD 21 ] vs 4 % [ 2 ] ; difference 15 % , p=0·005 ) . At the 6-month follow-up visit , the proportion h and washing with soap was 37 % ( SD 7 ) in the intervention group versus 6 % ( 3 ) in the control group ( difference 31 % ; p=0·02 ) . At the 12-month follow-up visit , after the control villages had received the shortened intervention , the proportion h and washing with soap was 29 % ( SD 9 ) in the intervention group and 29 % ( 13 ) in the control group . INTERPRETATION This study shows that substantial increases in h and washing with soap can be achieved using a scalable intervention based on emotional drivers . FUNDING Wellcome Trust , SHARE Background We analyzed data from the baseline assessment of a large intervention project to describe typical h and washing practice s in rural Bangladesh , and compare measures of h and cleanliness with household characteristics . Methods We r and omly selected 100 villages from 36 districts in rural Bangladesh . Field workers identified 17 eligible households per village using systematic sampling . Field workers conducted 5-hour structured observations in 1000 households , and a cross-sectional assessment in 1692 households that included spot checks , an evaluation of h and cleanliness and a request that residents demonstrate their usual h and washing practice s after defecation . Results Although 47 % of caregivers reported and 51 % demonstrated washing both h and s with soap after defecation , in structured observation , only 33 % of caregivers and 14 % of all persons observed washed both h and s with soap after defecation . Less than 1 % used soap and water for h and washing before eating and /or feeding a child . More commonly people washed their h and s only with water , 23 % after defecation and 5 % before eating . Spot checks during the cross sectional survey classified 930 caregivers ( 55 % ) and 453 children ( 28 % ) as having clean appearing h and s. In multivariate analysis economic status and water available at h and washing locations were significantly associated with h and cleanliness among both caregivers and children . Conclusions A minority of rural Bangladeshi residents washed both h and s with soap at key h and washing times , though rinsing h and s with only water was more common . To realize the health benefits of h and washing , efforts to improve h and washing in these communities should target adding soap to current h and rinsing practice Background In Bangladesh diarrhoeal disease and respiratory infections contribute significantly to morbidity and mortality . H and washing with soap reduces the risk of infection ; however , h and washing rates in infrastructure-restricted setting s remain low . H and washing stations – a dedicated , convenient location where both soap and water are available for h and washing – are associated with improved h and washing practice s. Our aim was to identify a locally feasible and acceptable h and washing station that enabled frequent h and washing for two subsequent r and omized trials testing the health effects of this behaviour . Methods We conducted formative research in the form of household trials of improved practice s in urban and rural Bangladesh . Seven c and i date h and washing technologies were tested by nine to ten households each during two iterative phases . We conducted interviews with participants during an introductory visit and two to five follow up visits over two to six weeks , depending on the phase . We used the Integrated Behavioural Model for Water , Sanitation and Hygiene ( IBM-WASH ) to guide selection of c and i date h and washing stations and data analysis . Factors presented in the IBM-WASH informed thematic coding of interview transcripts and context ualized feasibility and acceptability of specific h and washing station design s. Results Factors that influenced selection of c and i date design s were market availability of low cost , durable material s that were easy to replace or replenish in an infrastructure-restricted and shared environment . Water storage capacity , ease of use and maintenance , and quality of material s determined the acceptability and feasibility of specific h and washing station design s. After examining technology , psychosocial and context ual factors , we selected a h and washing system with two different water storage capacities , each with a tap , st and , basin , soapy water bottle and detergent powder for pilot testing in preparation for the subsequent r and omized trials . Conclusions A number of context ual , psychosocial and technological factors influence use of h and washing stations at five aggregate levels , from habitual to societal . In interventions that require a h and washing station to facilitate frequent h and washing with soap , elements of the technology , such as capacity , durability and location(s ) within the household are key to high feasibility and acceptability . More than one h and washing station per household may be required . IBM-WASH helped guide the research and research in-turn helped vali date the framework In this study , we report on the results of a trial of an intervention to improve five food hygiene behaviors among mothers
Output:
| Hygiene promotion programmes are likely to be most successful if they use multi-modal approaches , combining infrastructural improvement with ' soft ' hygiene promotion which addresses a range of determinants rather than just education about disease transmission |
MS212239 | ***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: OBJECTIVE To assess the effectiveness of structured blood glucose testing in poorly controlled , noninsulin-treated type 2 diabetes . RESEARCH DESIGN AND METHODS This 12-month , prospect i ve , cluster-r and omized , multicenter study recruited 483 poorly controlled ( A1C ≥7.5 % ) , insulin-naïve type 2 diabetic subjects from 34 primary care practice s in the U.S. Practice s were r and omized to an active control group ( ACG ) with enhanced usual care or a structured testing group ( STG ) with enhanced usual care and at least quarterly use of structured self-monitoring of blood glucose ( SMBG ) . STG patients and physicians were trained to use a paper tool to collect/interpret 7-point glucose profiles over 3 consecutive days . The primary end point was A1C level measured at 12 months . RESULTS The 12-month intent-to-treat analysis ( ACG , n = 227 ; STG , n = 256 ) showed significantly greater reductions in mean ( SE ) A1C in the STG compared with the ACG : −1.2 % ( 0.09 ) vs. −0.9 % ( 0.10 ) ; Δ = −0.3 % ; P = 0.04 . Per protocol analysis ( ACG , n = 161 ; STG , n = 130 ) showed even greater mean ( SE ) A1C reductions in the STG compared with the ACG : −1.3 % ( 0.11 ) vs. −0.8 % ( 0.11 ) ; Δ = −0.5 % ; P < 0.003 . Significantly more STG patients received a treatment change recommendation at the month 1 visit compared with ACG patients , regardless of the patient ’s initial baseline A1C level : 179 ( 75.5 % ) vs. 61 ( 28.0 % ) ; < 0.0001 . Both STG and ACG patients displayed significant ( P < 0.0001 ) improvements in general well-being ( GWB ) . CONCLUSIONS Appropriate use of structured SMBG significantly improves glycemic control and facilitates more timely/aggressive treatment changes in noninsulin-treated type 2 diabetes without decreasing GWB Objectives To assess the effect of self monitoring of blood glucose concentrations on glycaemic control and psychological indices in patients with newly diagnosed type 2 diabetes mellitus . Design Prospect i ve r and omised controlled trial of self monitoring versus no monitoring ( control ) . Setting Hospital diabetes clinics . Participants 184 ( 111 men ) people aged < 70 with newly diagnosed type 2 diabetes referred to the participating diabetes clinics . Major exclusion criteria were secondary diabetes , insulin treatment , previous self monitoring of blood glucose . Interventions Participants were r and omised to self monitoring or no monitoring ( control ) groups for one year with follow-up at three monthly intervals . Both groups underwent an identical structured core education programme . The self monitoring group received additional education on monitoring . Main outcome measures Between group differences in HbA1c , psychological indices , use of oral hypoglycaemic drugs , body mass index ( BMI ) , and reported hypoglycaemia rates . Results 96 patients ( 55 men ) were r and omised to monitoring and 88 ( 56 men ) to control . There were no baseline differences in mean ( SD ) age ( 57.7 ( 11.0 ) in monitoring group v 60.9 ( 11.5 ) in control group ) or HbA1c ( 8.8 (2.1)% v 8.6 (2.3)% , respectively ) . Those in the monitoring group had a higher baseline BMI ( 34 ( 7 ) v 32 ( 6.2 ) ) . There were no significant differences between groups at any time point ( 12 months values given ) in HbA1c ( 6.9 (0.8)% v 6.9 (1.2)% , P=0.69 ; 95 % confidence interval for difference −0.25 % to 0.38 % ) , BMI ( 33.1 ( 6.4 ) v 31.8 ( 6.0 ) ; adjusted for baseline BMI , P=0.32 ) , use of oral hypoglycaemic drugs , or reported incidence of hypoglycaemia . Monitoring was associated with a 6 % higher score on the depression subscale of the well-being question naire ( P=0.01 ) . Conclusions In patients with newly diagnosed type 2 diabetes self monitoring of blood glucose concentration has no effect on glycaemic control but is associated with higher scores on a depression subscale . Trial registration IS RCT N 49814766 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 AIM To determine if therapeutic management programmes for type 2 diabetes that include self-monitoring of blood glucose ( SMBG ) result in greater reductions in glycated haemoglobin ( HbA1c ) compared with programmes without SMBG in non-insulin requiring patients . METHODS Multicentre , r and omized , parallel-group trial . A total of 610 patients were r and omized to SMBG or non-SMBG groups . Patients in both groups received the same oral antidiabetic therapy using a gliclazide modified release (MR)-based regimen for 27 weeks . The primary efficacy end-point was the difference between groups in HbA1c at the end of observation . RESULTS A total of 610 patients were r and omized : 311 to the SMBG group and 299 to the non-SMBG group . HbA1c decreased from 8.12 to 6.95 % in the SMBG group and from 8.12 to 7.20 % in the non-SMBG group ; between-group difference was 0.25 % ( 95 % CI : 0.06 , 1.03 ; p = 0.0097 ) . Symptoms suggestive of mild to moderate hypoglycaemia was the most commonly reported adverse event , reported by 27 ( 8.7 % ) and 21 ( 7.0 % ) patients in the SMBG and non-SMBG groups , respectively ; the incidence of symptomatic hypoglycaemia was lower in the SMBG group . CONCLUSION In patients with type 2 diabetes , the application of SMBG as an adjunct to oral antidiabetic agent therapy results in further reductions in HbA1c 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 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 To assess the cost effectiveness of self monitoring of blood glucose alone or with additional training in incorporating the results into self
Output:
| Recent evidence demonstrates that when SMBG is ' structured ' , incorporated as part of a complex intervention , and embedded within education and collaborative care , improvements in average blood glucose levels result .
In contrast , studies that do not apply SMBG systematic ally , or that assess a low frequency SMBG regimen that precludes identification and interpretation of SMBG patterns , are not clinical ly effective .
CONCLUSIONS It is the quality , not quantity , of SMBG that makes a difference to outcomes for people with non-insulin-treated T2DM . |
MS212240 | ***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: OBJECTIVE Little is known about the optimal duration of antibiotic therapy for diabetic foot osteomyelitis ( DFO ) . This study sought to compare the effectiveness of 6 versus 12 weeks of antibiotic therapy in patients with DFO treated nonsurgically ( i.e. , antibiotics alone ) . RESEARCH DESIGN AND METHODS This was a prospect i ve r and omized trial comparing 6- versus 12-week duration of antibiotic treatment . Remission of osteomyelitis during the monitoring period was defined as complete and persistent ( > 4 weeks ) healing of the wound ( if present initially ) , absence of recurrent infection at the initial site or that of adjacent rays , and no need for surgical bone resection or amputation at the end of a follow-up period of at least 12 months after completion of antibiotic treatment . RESULTS Forty patients followed at five French general hospitals were r and omized between January 2007 and January 2009 , with 20 treated for 6 weeks and 20 treated for 12 weeks with antibiotics . The two groups were comparable for all variables recorded at inclusion in the study . Remission was obtained in 26 ( 65 % ) patients , with no significant differences between patients treated for 6 versus 12 weeks ( 12/20 vs. 14/20 , respectively ; P = 0.50 ) . We did not identify any significant parameters associated with patient outcome . Fewer patients treated for 6 weeks experienced gastrointestinal adverse events related to antimicrobial therapy compared with patients treated for 12 weeks ( respectively , 15 vs. 45 % ; P = 0.04 ) . CONCLUSIONS The present multicenter prospect i ve r and omized study provides data suggesting that 6-week duration of antibiotic therapy may be sufficient in patients with DFO for whom nonsurgical treatment is considered A phase 3 , r and omized , double-blind trial was conducted in subjects with diabetic foot infections without osteomyelitis ( primary study ) or with osteomyelitis ( sub study ) to determine the efficacy and safety of parenteral ( intravenous [ iv ] ) tigecycline ( 150 mg once-daily ) versus 1 g once-daily iv ertapenem ± vancomycin . Among 944 subjects in the primary study who received ≥1 dose of study drug , > 85 % had type 2 diabetes ; ~90 % had Perfusion , Extent , Depth/tissue loss , Infection , and Sensation infection grade 2 or 3 ; and ~20 % reported prior antibiotic failure . For the clinical ly evaluable population at test-of-cure , 77.5 % of tigecycline- and 82.5 % of ertapenem ± vancomycin-treated subjects were cured . Corresponding rates for the clinical modified intent-to-treat population were 71.4 % and 77.9 % , respectively . Clinical cure rates in the sub study were low ( < 36 % ) for a subset of tigecycline-treated subjects with osteomyelitis . Nausea and vomiting occurred significantly more often after tigecycline treatment ( P = 0.003 and P < 0.001 , respectively ) , result ing in significantly higher discontinuation rates in the primary study ( nausea P = 0.007 , vomiting P < 0.001 ) . In the primary study , tigecycline did not meet criteria for noninferiority compared with ertapenem ± vancomycin in the treatment of subjects with diabetic foot infections BACKGROUND This r and omized , prospect i ve , multicenter , open-label study was design ed to test whether a topical , electrolyzed , superoxidized solution ( Microcyn Rx ) is a safe and effective treatment for mildly infected diabetic foot ulcers . METHODS Sixty-seven patients with ulcers were r and omized into three groups . Patients with wounds irrigated with Microcyn Rx alone were compared with patients treated with oral levofloxacin plus normal saline wound irrigation and with patients treated with oral levofloxacin plus Microcyn Rx wound irrigation . Patients were evaluated on day 3 , at the end of treatment on day 10 ( visit 3 ) , and 14 days after completion of therapy for test of cure ( visit 4 ) . RESULTS In the intention-to-treat sample at visit 3 , the clinical success rate was higher in the Microcyn Rx alone group ( 75.0 % ) than in the saline plus levofloxacin group ( 57.1 % ) or in the Microcyn Rx plus levofloxacin group ( 64.0 % ) . Results at visit 4 were similar . In the clinical ly evaluable population , the clinical success rate at visit 3 ( end of treatment ) for patients treated with Microcyn Rx alone was 77.8 % versus 61.1 % for the levofloxacin group . The clinical success rate at visit 4 ( test of cure ) for patients treated with Microcyn Rx alone was 93.3 % versus 56.3 % for levofloxacin plus saline-treated patients . This study was not statistically powered , but the high clinical success rate ( 93.3 % ) and the P value ( P = .033 ) suggest that the difference is meaningfully positive for Microcyn Rx-treated patients . CONCLUSIONS Microcyn Rx is safe and at least as effective as oral levofloxacin for mild diabetic foot infections Abstract Aims /hypothesis . To re-evaluate the use of Granulocyte-Colony Stimulating Factor ( G-CSF ) in the treatment of infected diabetic foot ulcers . Methods . Thirty-seven diabetic subjects were r and omised to Granulocyte-Colony Stimulating Factor ( G-CSF ) ( n=20 ) or placebo ( n=17 ) . The primary endpoint was resolution of cellulitis , which was evaluated clinical ly and with an infection summary score . Patients were hospitalised for 10 days and received subcutaneously either 5 µg/kg G-CSF or placebo daily . Ulcers were treated with a st and ard wound protocol and the patients were instructed to stay in bed . All subjects received antibiotics ( clindamycin and ciprofloxacin ) intravenously until the inflammation had subsided . Results . Patients who received G-CSF did not have an earlier resolution of clinical ly defined cellulitis ( p=0.57 ) . The infection summary score declined , but comparably , in both groups ( G-CSF : 29.5±18.4 to 6.7±6.3 p<0.001 , placebo : 24.2±16.9 to 8.9±7.2 p<0.001 ) . The ulcer volume , which was not greater among placebo patients , was reduced by 59 % in G-CSF and by 35 % in placebo patients . Conclusion /interpretation . We conclude that antibiotic and non weight-bearing therapy ( bed rest ) accelerated the resolution of cellulitis in infected foot ulcers . Additional treatment with G-CSF had no further beneficial effect This study tested whether levofloxacin , at a new high dose of 750 mg , was effective for the treatment of complicated skin and skin-structure infections ( SSSIs ) . Patients with complicated SSSIs ( n=399 ) were r and omly assigned in a ratio of 1:1 to 2 treatment arms : levofloxacin ( 750 mg given once per day intravenously [ iv ] , orally , or iv/orally ) or ticarcillin-clavulanate ( TC ; 3.1 g given iv every 4 - 6 hours ) followed , at the investigator 's discretion , by amoxicillin-clavulanate ( AC ; 875 mg given orally every 12 hours ) . In the clinical ly evaluable population , therapeutic equivalence was demonstrated between the levofloxacin and TC/AC regimens ( success rates of 84.1 % and 80.3 % , respectively ) . In the microbiologically evaluable population , the overall rate of eradication was 83.7 % in the levofloxacin treatment group and 71.4 % in the TC/AC treatment group ( 95 % confidence interval , -24.3 to -0.2 ) . Both levofloxacin and TC/AC were well tolerated . These data demonstrate that levofloxacin ( 750 mg once per day ) is safe and at least as effective as TC/AC for complicated SSSIs OBJECTIVE To investigate the change of bacterial load applied with iodophors and rivanol of diabetic foot ulcers ( DFUs ) , furthermore to evaluate the effect of both in removing superficial microbes of DFUs . METHODS From March 2006 to March 2007 , 30 patients were r and omly divided into control group ( group A , n = 10 ) , iodophor group ( group B , n = 10 ) and rivanol group ( group C , n = 10 ) . There were 18 males and 12 females with an average age of 59.8 years ( range 46 - 78 years ) . The wound size ranged from 3 cm x 2 cm to 15 cm x 10 cm . The disease course was 6 weeks to 6 months ( mean 2.1 months ) . Each wound was debrided and irrigated before process , then drug was compressed on the wound for 5 minutes , and irrigated again . The sample s gained for three times , before , immediately and 24 hours after the process . Each sample was diluted before cultivation , the bacteria of wound were counted and compared among 3 groups . RESULTS The cultures of specimens showed that the load decreased in every group , each cultured colony of specimen grew well , and there were no significant differences between 3 groups immediately after procedure ( P > 0.05 ) . There were significant differences between group B and groups A , C ( P < 0.05 ) , but there were no significant difference between group A and group C 24 hours after treatment ( P > 0.05 ) . CONCLUSION Both iodophors and rivanol could remove the bacteria on the surface of wound . Topical germicide could reduced bacterial load in the wound of diabetic foot , the role of sterilizing and bacteriostasis of iodophors were better than that of rivanol Background Chronic foot ulcers in diabetes are serious , costly and frequently difficult to heal . Recent guidelines conclude that new dressings and treatments generally fail to show superiority compared with st and ard of care . Several mechanisms are probably responsible for impaired healing of chronic foot ulcers , including inflammation and infection . Chloramines have presumed antiseptic and antibacterial properties , and have shown to be a useful treatment in odontology . Methods In an explorative open r and omised controlled multi-centre study , we compared chloramine-based treatment with current st and ard of care for 12 weeks and follow-up for 24 weeks . Seventeen patients in each group , mean age about 70 , duration of diabetes > 20 years and foot ulcers about 1.5 years , completed the 12 weeks study . Results After 5 weeks , the difference between the groups in relative reduction in ulcer area was statistically significant ( p=0.016 ) . Absolute change in ulcer area was first statistically significant within the chloraminetreated group after 2 weeks ( p=0.026 ) , after 8 weeks in the control group ( p=0.0023 ) , with significant difference between groups after 5 weeks ( p=0.024 ) . The approximate relative decrease per week was 19.4 % ( 95%CI 12.2 , 26.0 ; p<0.0001 ) in the chloramine-treated group and 11.7 % ( 95%CI 6.4 , 16.7 ; p<0.0001 ; between-group difference p=0.083 ) . After 9 weeks 7 patients had healed in the chloraminetreated group , but only one in the control group ( p=0.039 ) . There were no statistically significant differences in wound healing at 12 or 24 weeks , and no marked differences in signs of infection , pain , quality of life ( EQ-5D ) , or incidence of adverse events . Conclusions Chloramine-based treatment seems to be efficacious , particularly in the early phase of the care of infected diabetic foot ulcers . It is safe and easy to use , and could prove to be a valuable addition in the treatment arsenal , providing non-surgical debridement . Future studies will evaluate its role in wound care BACKGROUND The aim of this pilot study was to determine the safety and potential benefit of adding a topical gentamicin-collagen sponge to st and ard of care ( systemic antibiotic therapy plus st and ard diabetic wound management ) for treating diabetic foot infections of moderate severity . METHODS We r and omized 56 patients with moderately infected diabetic foot ulcers in a 2:1 ratio to receive st and ard of care plus the gentamicin-collagen sponge ( treatment group , n = 38 ) or st and ard of care only ( control group , n = 18 ) for up to 28 days of treatment . Investigators performed clinical , microbiological , and safety assessment s at regularly scheduled intervals and collected pharmacokinetic sample s from patients treated with the gentamicin-collagen sponge . Test of cure was clinical ly assessed 14 days after all antibiotic therapy was stopped . RESULTS On treatment day 7 , we noted clinical cure in no treatment patients and three control patients ( P = .0
Output:
| Thus , our systematic review revealed little evidence upon which to make recommendations for treatment of DFIs . |
MS212241 | ***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 The effectiveness of post-deployment screening for mental disorders has not been assessed in a r and omised controlled trial . We aim ed to assess whether post-deployment screening for post-traumatic stress disorder ( PTSD ) , depression , anxiety , or alcohol misuse was effective . We defined screening as the presumptive identification of a previously unrecognised disorder using tests to distinguish those who probably had the disorder from those who probably did not so that those people with a probable disorder could be referred appropriately , and assessed effectiveness and consequences for help-seeking by the odds ratio at follow-up between those receiving tailored help-seeking advice and those who received general mental health advice . METHODS We did a cluster r and omised controlled trial among Royal Marines and Army personnel in the UK military after deployment to Afghanistan . Platoons were r and omly assigned ( 1:1 initially , then 2:1 ) by stratified block r and omisation with r and omly varying block sizes of two and four to the screening group , which received tailored help-seeking advice , or the control group , which received general mental health advice . Initial assessment took place 6 - 12 weeks after deployment ; follow-up assessment s were done 10 - 24 months later . Follow-up measures were the PTSD Checklist-Civilian Version , Patient Health Question naire-9 , Generalised Anxiety Disorder-7 scale , Alcohol Use Disorder Identification Test ( AUDIT ) , and self-reported help-seeking from clinical and welfare providers comparing those receiving tailored advice and those receiving only general advice . All participants and all investigators other than the person who analysed the data were masked to allocation . The primary outcomes were PTSD , depression or generalised anxiety disorder , and alcohol misuse at follow-up . A key secondary outcome was assessment of whether post-deployment screening followed by tailored advice would modify help-seeking behaviour . Comparisons were made between screening and control groups , with primary analyses by intention to treat . This trial is registered with the IS RCT N Registry , number IS RCT N19965528 . FINDINGS Between Oct 24 , 2011 , and Oct 31 , 2014 , 434 platoons comprising 10 190 personnel were included : 274 ( 6350 personnel ) in the screening group and 160 ( 3840 personnel ) in the control group . 5577 ( 88 % ) of 6350 personnel received screening and 3996 ( 63 % ) completed follow-up , whereas 3149 ( 82 % ) of 3840 received the control question naire and 2369 ( 62 % ) completed follow-up . 1958 ( 35 % ) of 5577 personnel in the screening group declined to see the tailored advice , but those with PTSD ( 83 % ) or anxiety or depression ( 84 % ) were more likely than non-cases ( 64 % ) to view the advice ( both p<0·0001 ) . At follow-up , there were no significant differences in prevalence between groups for PTSD ( adjusted odds ratio 0·92 , 95 % CI 0·75 - 1·14 ) , depression or anxiety ( 0·91 , 0·71 - 1·16 ) , alcohol misuse ( 0·88 , 0·73 - 1·06 ) , or seeking support for mental disorders ( 0·92 , 0·78 - 1·08 ) . INTERPRETATION Post-deployment screening for mental disorders based on tailored advice was not effective at reducing prevalence of mental health disorders nor did it increase help-seeking . Countries that have implemented post-deployment screening programmes for mental disorders should consider monitoring the outcomes of their programmes . FUNDING The US Army Medical Research and Materiel Comm and -Military Operational Medicine Research Program ( USAMRMC-MOMRP ) Acceptance and commitment therapy ( ACT ) has previously been shown to alter stigmatizing attitudes and to be relatively useful for psychologically inflexible participants . The present study is the first to bring those two findings together by comparing ACT to an education intervention for reducing stigma toward people with psychological disorders , and examining whether results differ for psychologically inflexible versus flexible individuals . A sample of college students ( N = 95 ) was r and omly assigned to a 2(1)2h ACT or educational workshop . Measures were taken before and after the workshop and at a 1-month follow-up . ACT reduced mental health stigma significantly regardless of participants ' pre-treatment levels of psychological flexibility , but education reduced stigma only among participants who were relatively flexible and non-avoidant to begin with . Acceptance could be an important avenue of exploration for stigma research ers This article reports pilot data from phase I of a project to develop and evaluate a self-directed program of integrative therapies for National Guard personnel and significant relationship partners to support reintegration and resilience after return from Iraq or Afghanistan . Data are reported on 43 dyads . Intervention was an integrated multimedia package of guided meditative , contemplative , and relaxation exercises ( CD ) and instruction in simple massage techniques ( DVD ) to promote stress reduction and interpersonal connectedness . A repeated measures design with st and ardized instruments was used to establish stability of baseline levels of relevant mental health domains ( day 1 , day 30 ) , followed by the intervention and assessment s 4 and 8 weeks later . Significant improvements in st and ardized measures for post-traumatic stress disorder , depression , and self-compassion were seen in both veterans and partners ; and in stress for partners . Weekly online reporting tracked utilization of guided exercises and massage . Veterans reported significant reductions in ratings of physical pain , physical tension , irritability , anxiety/worry , and depression after massage , and longitudinal analysis suggested declining baseline levels of tension and irritability . Qualitative data from focus groups and implication s for continued development and a phase II trial are discussed Background : Many veterans deployed after 9/11/2001 are impacted by subthreshold levels of post-traumatic stress , anxiety , or other psychological health problems that may interfere with successful reintegration . Conventional treatments , including medication and trauma-focused individual psychotherapies , may not be optimally adapted , accepted , or effective to treat these subsyndromal symptoms . Methods : We developed “ Resilient Warrior , ” a 4-session , group-based , mind-body stress-management and resilience program targeted to build skills and assessed whether its format was accessible and acceptable , and potentially efficacious , to support resilience among service members . Results : From April 2014 to October 2014 , 15 participants ( 53.3 % women ; mean age=36.6 y ; SD=6.2 ) were surveyed for program acceptability and feasibility and completed self-reported psychological health outcomes before and after program participation . The majority ( 71.4 % ) of participants reported that the program included the right number of sessions , and all of them reported that it was helpful and relevant and that they would recommend it to others . While changes in self-reported resilience were only marginal , participation was associated with improvements in depressive symptoms , perceived stress , anxiety , and general sense of self efficacy . Conclusion : These pilot data provide preliminary support that “ Resilient Warrior , ” a group-based , stress reduction and resilience program , may improve psychological health in service members even when delivered in community setting s. R and omized controlled trials with longer follow-up periods are needed to establish efficacy and effectiveness for this program OBJECTIVE Anger and aggression are serious problems for a significant proportion of veterans who have served in combat . While prior research has suggested that cognitive behavioral treatments may be effective for anger problems , there are few controlled studies of anger treatment in veterans and no studies of anger treatment focusing exclusively on veterans from the Iraq and Afghanistan wars . This r and omized pilot study compared an adapted cognitive behavioral intervention ( CBI ) to a supportive intervention ( SI ) control condition for the treatment of anger problems in veterans returning from deployment in Iraq or Afghanistan . METHODS 25 veterans with warzone trauma , problems with anger , and one or more additional hyperarousal symptoms were r and omized and 23 started treatment ( CBI , n = 12 ; SI , n = 11 ) . Outcome measures were administered at pre- and post- treatment and at 3 months post-treatment . RESULTS CBI was associated with significantly more improvement than SI on measures of anger and interpersonal functioning . Gains were maintained at follow-up . CONCLUSIONS Findings suggest that CBI may be more effective than an active control providing psychoeducation , relaxation , and supportive therapy for treating anger problems in returning veterans . The findings need to be replicated in an adequately powered and more diverse sample The decade long conflicts in Iraq and Afghanistan have placed considerable strain on military families . Given robust data showing high rates of deployment-related psychological health problems in spouses and children , and the near absence of evidence -based psychological health programs for military families in the community , interventions are urgently needed to support and strengthen spouses as they adjust to deployment transitions and military life experiences . This Phase 1 pilot study evaluated the feasibility and acceptability of a resiliency intervention for military spouses in civilian communities ( HomeFront Strong ; HFS ) , and generated preliminary efficacy data regarding impacts on psychological health and adjustment . Through two group cohorts , 14 women completed the intervention , with 10 women providing pre- and postgroup assessment data . Findings support feasibility of the intervention and high rates of program satisfaction . Participants reported learning new strategies and feeling more knowledgeable in their ability to use effective coping skills for managing deployment and military-related stressors . Participation in HFS was also associated with reduction in levels of anxiety and perceived stress , and improvements in life satisfaction and life engagement . HFS is a promising community-based intervention for military spouses design ed to enhance resiliency , reduce negative psychological health symptoms , and improve coping BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application Background Veterans with history of deployment in the Global War on Terror face significant and ongoing challenges with high prevalences of adverse psychological , physical , spiritual , and family impacts . Together , these challenges contribute to an emerging public health crisis likely to extend well into the future . Innovative approaches are needed that reach veterans and their family members with strategies they can employ over time in their daily lives to promote improved adjustment and well-being . Objective The objective of this study was to evaluate effects of use of a Web-based , self-directed program of instruction in mind- and body-based wellness skills to be employed by Global War on Terror veterans and their significant relationship partners on mental health and wellness outcomes associated with postdeployment readjustment . Methods We recruited 160 veteran-partner dyads in 4 regions of the United States ( San Diego , CA ; Dallas , TX ; Fayetteville , NC ; and New York , NY ) through publicity by the Iraq and Afghanistan Veterans of America to its membership . Dyads were r and omly allocated to 1 of 4 study arms : Mission Reconnect ( MR ) program alone , MR plus the Prevention and Relationship Enhancement Program ( PREP ) for Strong Bonds weekend program for military couples , PREP alone , and waitlist control . We administered a battery of st and ardized and investigator-generated instruments assessing mental health outcomes at baseline , 8 weeks , and 16 weeks . Dyads in the MR arms were provided Web-based and mobile app video and audio instruction in a set of mindfulness-related stress reduction and contemplative practice s , as well as partner massage for reciprocal use . All participants provided weekly reports on frequency and duration of self-care practice s for the first 8 weeks , and at 16 weeks . Results During the first 8-week reporting period , veterans and partners assigned to MR arms used some aspect of the program a mean of 20 times per week , totaling nearly 2.5 hours per week , with only modest declines in use at 16 weeks . Significant improvements were seen at 8 and 16 weeks in measures of posttraumatic stress disorder , depression , sleep quality , perceived stress , resilience , self-compassion , and pain for participants assigned to MR arms . In addition , significant reductions in self-reported levels of pain , tension , irritability , anxiety , and depression were associated with use of partner massage . Conclusions Both veterans and partners were able to learn and make sustained use of a range of wellness practice s taught in the MR program . Home-based , self-directed inter
Output:
| Interventions had some significant positive effects mostly for veterans adjusting to civilian life and other family members . |
MS212242 | ***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: Abbreviations ACCORD Action to Control Cardiovascular Risk in Diabetes ADVANCE Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified-Release Controlled Evaluation AGI α-Glucosidase inhibitor CAD Coronary artery disease CKD Chronic kidney disease CVD Cardiovascular disease DPP-4 Dipeptidyl peptidase IV GIP Glucose-dependent insulinotropic peptide GLP-1 Glucagon-like peptide 1 NPH Neutral protamine Hagedorn TZD Thiazolidinedione UKPDS UK Prospect i ve Diabetes Study VADT Veterans Affairs Diabetes OBJECTIVE Low vitamin D levels predict the development of diabetes . This double-blind , r and omized , control study in subjects with prediabetes and hypovitaminosis D evaluated whether high doses of vitamin D for 1 year affected insulin secretion , insulin sensitivity , and the development of diabetes . RESEARCH DESIGN AND METHODS A total of 1,551 subjects ≥40 years of age not known to have diabetes were screened with A1C levels . Subjects with A1C levels of 5.8–6.9 % underwent an oral glucose tolerance test ( OGTT ) . Subjects with prediabetes and 25-OH vitamin D ( 25-OHD ) levels < 30 ng/mL were r and omized to receive weekly placebo ( n = 53 ) or vitamin D ( n = 56 ) with doses based on body weight and baseline 25-OHD levels . OGTTs were performed 3 , 6 , 9 , and 12 months later . Insulin secretion and sensitivity were measured , and the proportion of subjects developing diabetes was assessed . RESULTS 25-OHD levels rapidly rose from 22 to nearly 70 ng/mL after vitamin D supplementation with a mean weekly dose of 88,865 IU . There were no differences between the placebo and vitamin D groups regarding fasting plasma glucose , 2-h glucose , or insulin secretion and sensitivity or in the percent developing diabetes or returning to normal glucose tolerance . No subjects experienced increased serum or urinary calcium levels . At 12 months , A1C levels were significantly slightly less ( 0.2 % ) in the vitamin D group . CONCLUSIONS In individuals with prediabetes and hypovitaminosis D , doses of vitamin D supplementation design ed to raise serum 25-OHD levels into the upper-normal range for 1 year had no effect on insulin secretion , insulin sensitivity , or the development of diabetes compared with placebo administration BACKGROUND & AIMS Type 2 diabetes has been associated with dysbiosis and one of the possible routes to restore a healthy gut microbiota is by the regular ingestion of probiotics . We aim ed to investigate the effects of probiotics on glycemic control , lipid profile , inflammation , oxidative stress and short chain fatty acids in T2D . METHODS In a double-blind , r and omized , placebo-controlled trial , 50 volunteers consumed daily 120 g/d of fermented milk for 6 wk . Participants were assigned into two groups : probiotic group , consuming fermented milk containing Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp lactis BB-12 ( 109 colony-forming units/d , each ) and control group , consuming conventional fermented milk . Anthropometric measurements , body composition , fasting blood and faecal sample s were taken at baseline and after 6 wk . RESULTS 45 subjects out of 50 ( 90 % ) completed follow-up . After 6 wk , there was a significant decrease in fructosamine levels ( -9.91 mmol/L ; p = 0.04 ) and hemoglobin A1c tended to be lower ( -0.67 % ; p=0.06 ) in probiotic group . TNF-α and resistin were significantly reduced in probiotic and control groups ( -1.5 and -1.3 pg/mL , -.1 and -2.8 ng/mL , respectively ) , while IL-10 was significantly reduced ( - 0.65 pg/mL ; p < 0.001 ) only in the control group . Fecal acetic acid was increased in both groups ( 0.58 and 0.59 % in probiotic and control groups , respectively ; p < 0.01 ) . There was a significant difference between groups concerning mean changes of HbA1c ( + 0.31 for control group vs -0.65 for probiotic group ; p=0.02 ) , total cholesterol ( + 0.55 for control group vs -0.15 for probiotic group ; p=0.04 ) and LDL-cholesterol ( + 0.36 for control group vs -0.20 for probiotic group p=0.03 ) . CONCLUSIONS Probiotic consumption improved the glycemic control in T2D subjects , however , the intake of fermented milk seems to be involved with others metabolic changes , such as decrease in inflammatory cytokines ( TNF-α and resistin ) and increase in the acetic acid Aims The aim of this study was to compare the effects of calorie-restricted vegetarian and conventional diabetic diets alone and in combination with exercise on insulin resistance , visceral fat and oxidative stress markers in subjects with Type 2 diabetes . Methods A 24-week , r and omized , open , parallel design was used . Seventy-four patients with Type 2 diabetes were r and omly assigned to either the experimental group ( n = 37 ) , which received a vegetarian diet , or the control group ( n = 37 ) , which received a conventional diabetic diet . Both diets were isocaloric , calorie restricted ( -500 kcal/day ) . All meals during the study were provided . The second 12 weeks of the diet were combined with aerobic exercise . Participants were examined at baseline , 12 weeks and 24 weeks . Primary outcomes were : insulin sensitivity measured by hyperinsulinaemic isoglycaemic clamp ; volume of visceral and subcutaneous fat measured by magnetic resonance imaging ; and oxidative stress measured by thiobarbituric acid reactive substances . Analyses were by intention to treat . Results Forty-three per cent of participants in the experimental group and 5 % of participants in the control group reduced diabetes medication ( P < 0.001 ) . Body weight decreased more in the experimental group than in the control group [ –6.2 kg ( 95 % CI –6.6 to –5.3 ) vs. –3.2 kg ( 95 % CI –3.7 to –2.5 ) ; interaction group × time P = 0.001 ] . An increase in insulin sensitivity was significantly greater in the experimental group than in the control group [ 30 % ( 95 % CI 24.5–39 ) vs. 20 % ( 95 % CI 14–25 ) , P = 0.04 ] . A reduction in both visceral and subcutaneous fat was greater in the experimental group than in the control group ( P = 0.007 and P = 0.02 , respectively ) . Plasma adiponectin increased ( P = 0.02 ) and leptin decreased ( P = 0.02 ) in the experimental group , with no change in the control group . Vitamin C , superoxide dismutase and reduced glutathione increased in the experimental group ( P = 0.002 , P < 0.001 and P = 0.02 , respectively ) . Differences between groups were greater after the addition of exercise training . Changes in insulin sensitivity and enzymatic oxidative stress markers correlated with changes in visceral fat . Conclusions A calorie-restricted vegetarian diet had greater capacity to improve insulin sensitivity compared with a conventional diabetic diet over 24 weeks . The greater loss of visceral fat and improvements in plasma concentrations of adipokines and oxidative stress markers with this diet may be responsible for the reduction of insulin resistance . The addition of exercise training further augmented the improved outcomes with the vegetarian diet BACKGROUND Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus , but no large trials have compared interventions . We investigated the effects of diet and physical activity on blood pressure and glucose concentrations . METHODS We did a r and omised , controlled trial in southwest Engl and in adults aged 30 - 80 years in whom type 2 diabetes had been diagnosed 5 - 8 months previously . Participants were assigned usual care ( initial dietary consultation and follow-up every 6 months ; control group ) , an intensive diet intervention ( dietary consultation every 3 months with monthly nurse support ) , or the latter plus a pedometer-based activity programme , in a 2:5:5 ratio . The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c ) ) concentration and blood pressure at 6 months . Analysis was done by intention to treat . This study is registered , number IS RCT N92162869 . FINDINGS Of 593 eligible individuals , 99 were assigned usual care , 248 the diet regimen , and 246 diet plus activity . Outcome data were available for 587 ( 99 % ) and 579 ( 98 % ) participants at 6 and 12 months , respectively . At 6 months , glycaemic control had worsened in the control group ( mean baseline HbA(1c ) percentage 6·72 , SD 1·02 , and at 6 months 6·86 , 1·02 ) but improved in the diet group ( baseline-adjusted difference in percentage of HbA(1c ) -0·28 % , 95 % CI -0·46 to -0·10 ; p=0·005 ) and diet plus activity group ( -0·33 % , -0·51 to -0·14 ; p<0·001 ) . These differences persisted to 12 months , despite less use of diabetes drugs . Improvements were also seen in bodyweight and insulin resistance between the intervention and control groups . Blood pressure was similar in all groups . INTERPRETATION An intensive diet intervention soon after diagnosis can improve glycaemic control . The addition of an activity intervention conferred no additional benefit . FUNDING Diabetes UK and the UK Department of Health OBJECTIVE To analyze the effects of a home-based physical exercise program on quality of life , metabolic control , and anthropometric and biochemical parameters in people over 60 years of age with type 2 diabetes mellitus . METHODS Eighty-four Spanish patients aged over 60 years were finally r and omized to participate in a home-based , combined physical exercise program ( aerobic and anaerobic exercises ) or to receive conventional treatment for diabetes . At 6 months , effects on quality of life ( EuroQoL question naire ) . HbA1c , fasting glucose , hypoglycemic events , weight , BMI , waist circumference , blood pressure , and biochemical parameters were assessed . RESULTS Mean age of study participants was 66.7 ( 8.0 ) years . Patients in the exercise group showed an improved quality of life at six months based on EuroQol : 0.48 ( 0.38 ) vs 0.66 ( 0.35 ) and analogic scale 67.97 ( 18.92 ) vs 76.26 ( 20.14 ) . An improved glycemic control was also seen : HbA1c 6.35 vs 6.0 % and fasting glucose 151.2 ( 36.7 ) vs 137.6 ( 23.5 ) mg/dL , as well as a weight reduction by 1.7 kg . Hypoglycemic events did not increase . No benefits were seen in the control group . Ten subjects withdrew from the study before 6 months . CONCLUSIONS A home-based physical exercise program improves quality of life , glycemic control , and weight in type 2 diabetic patients older than 60 years Background : Diabetes is a global health problem in the world . Probiotic food has anti-diabetic property . The aim of this trial was to determine the effect of probiotic fermented milk ( kefir ) on glucose and lipid profile control in patients with type 2 diabetes mellitus . Methods : This r and omized double-blind placebo-controlled clinical trial was conducted on 60 diabetic patients aged 35 to 65 years . Patients were r and omly and equally ( n=30 ) assigned to consume either probiotic fermented milk ( kefir ) or conventional fermented milk ( dough ) for 8 weeks . Probiotic group consumed 600 ml/day probiotic fermented milk containing Lactobacillus casei , Lactobacillus acidophilus and Bifidobacteria and control group consumed 600 ml/day conventional fermented milk . Blood sample s tested for fasting blood glucose , HbA1C , triglyceride ( TG ) , total cholesterol , HDL-C and LDL-C at the baseline and end of the study . Results : The comparison of fasting blood glucose between two groups after intervention was statistically significant ( P=0.01 ) . After intervention , reduced HbA1C compared with the baseline value in probiotic fermented milk group was statistically significant ( P=0.001 ) , also the HbA1C level significantly decreased in probiotic group in comparison with control group ( P=0.02 ) adjusting for serum levels of glucose
Output:
| RESULTS The selected articles have shown that the implementation of physical activity programs ( aerobic , resistance , flexibility and combined exercises ) , and programs based on a higher intake of vegetables , grains , legumes , fruits , unsaturated fatty acids , as well as consumption of foods with low glycaemic index , calorie restriction , intake of probiotics , vitamin D supplementation and educational sessions about diabetes improves blood glucose levels , as well as the lipid profile , in patients with type 2 diabetes .
Physical activity and dietary programs are fundamental in the treatment and metabolic control of type 2 diabetes mellitus |
MS212243 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: BACKGROUND A r and omized clinical trial was conducted to evaluate whether the superior performance of dialectical behavior therapy ( DBT ) , a psychosocial treatment for borderline personality disorder , compared with treatment-as-usual in the community , is maintained during a 1-year posttreatment follow-up . METHODS We analyzed 39 women who met criteria for borderline personality disorder , defined by Gunderson 's Diagnostic Interview for Borderline Personality Disorder and DSM-III-R criteria , and who had a history of parasuicidal behavior . Subjects were r and omly assigned either to 1 year of DBT , a cognitive behavioral therapy that combines individual psychotherapy with group behavioral skills training , or to treatment-as-usual , which may or may not have included individual psychotherapy . Efficacy was measured on parasuicidal behavior ( Parasuicide History Interview ) , psychiatric inpatient days ( Treatment History Interview ) , anger ( State-Trait Anger Scale ) , global functioning ( Global Assessment Scale ) , and social adjustment ( Social Adjustment Scale -- Interview and Social Adjustment Scale -- Self-Report ) . Subjects were assessed at 6 and 12 months into the follow-up year . RESULTS Comparison of the two conditions revealed that throughout the follow-up year , DBT subjects had significantly higher Global Assessment Scale scores . During the initial 6 months of the follow-up , DBT subjects had significantly less parasuicidal behavior , less anger , and better self-reported social adjustment . During the final 6 months , DBT subjects had significantly fewer psychiatric inpatient days and better interviewer-rated social adjustment . CONCLUSION In general , the superiority of DBT over treatment-as-usual , found in previous studies at the completion of 1 year of treatment , was retained during a 1-year follow-up Dialectical behaviour therapy ( DBT ) has proven to be an effective treatment in borderline personality disorder ( BPD ) . However , the effectiveness in BPD of DBT skills training ( DBT-ST ) alone is not known . This study aim ed at comparing the efficacy of DBT-ST and st and ard group therapy ( SGT ) for out patients with BPD . Sixty patients meeting the DSM-IV diagnostic criteria for BPD , as assessed by two semi-structured diagnostic interviews , were included in a 3-month , single-blind r and omised controlled trial . A total of 13 weekly group psychotherapy sessions of 120 min of either SGT or DBT-ST were conducted . Assessment s were carried out every 2 weeks by two blinded evaluators . Observer-rater , self-report scales and behavioural reports were used as outcome measures . DBT-ST was associated with lower dropout rates , 34.5 % compared to 63.4 % with SGT . It was superior to SGT in improving several mood and emotion areas , such as : depression , anxiety , irritability , anger and affect instability . A reduction in general psychiatric symptoms was also observed . Three-months weekly DBT-ST proved useful . This therapy was associated with greater clinical improvements and lower dropout rates than SGT . DBT-ST seems to play a role in the overall improvement of BPD seen with st and ard DBT intervention . It allows straightforward implementation in a wide range of mental health setting s and provides the additional advantage that it is cost effective OBJECTIVE The aim of this article is to examine whether st and ard Dialectical Behavior Therapy ( DBT ) ( 1 ) can be successfully implemented in a mixed population of borderline patients with or without comorbid substance abuse ( SA ) , ( 2 ) is equally efficacious in reducing borderline symptomatology among those with and those without comorbid SA , and ( 3 ) is efficacious in reducing the severity of the substance use problems . METHOD The implementation of DBT is examined qualitatively . The impact of comorbid SA on its efficacy , as well as on its efficacy in terms of reducing SA , is investigated in a r and omized clinical trial comparing DBT with treatment-as-usual ( TAU ) in 58 female borderline patients with ( n = 31 ) and without ( n = 27 ) SA . RESULTS St and ard DBT can be applied in a group of borderline patients with and without comorbid SA . Major implementation problems did not occur . DBT result ed in greater reductions of severe borderline symptoms than TAU , and this effect was not modified by the presence of comorbid SA . St and ard DBT , as it was delivered in our study , however , had no effect on SA problems . CONCLUSIONS St and ard DBT can be effectively applied with borderline patients with comorbid SA problems , as well as those without . St and ard DBT , however , is not more efficacious than TAU in reducing substance use problems . We propose that , rather than developing separate treatment programs for dual diagnosis patients , DBT should be " multitargeted . " This means that therapists ought to be trained in addressing a range of severe manifestations of personality pathology in the impulse control spectrum , including suicidal and self-damaging behaviors , binge eating , and SA This study tests the effectiveness of adding an eight-month , thirty-session schema-focused therapy ( SFT ) group to treatment-as-usual ( TAU ) individual psychotherapy for borderline personality disorder ( BPD ) . Patients ( N=32 ) were r and omly assigned to SFT-TAU and TAU alone . Dropout was 0 % SFT , 25 % TAU . Significant reductions in BPD symptoms and global severity of psychiatric symptoms , and improved global functioning with large treatment effect sizes were found in the SFT-TAU group . At the end of treatment , 94 % of SFT-TAU compared to 16 % of TAU no longer met BPD diagnosis criteria ( p<.001 ) . This study supports group SFT as an effective treatment for BPD that leads to recovery and improved overall functioning Motive-oriented therapeutic relationship ( MOTR , also called complementary therapeutic relationship ) was postulated to be a particularly helpful therapeutic ingredient in the early-phase treatment of patients with personality disorders , in particular borderline personality disorder ( BPD ) . The present pilot study of r and omized controlled trial using an add-on design aims to investigate the effects of MOTR in early-phase treatment ( up to session 10 ) , with BPD patients on therapeutic alliance , session impact , and outcome . In total , N = 25 patients participated in the study . BPD patients were r and omly allocated to a manual-based investigation process in 10 sessions or to the same investigation process infused with MOTR . Adherence ratings were performed and yielded satisfactory results . The results suggested a specific effectiveness of MOTR on the interpersonal problem area , on the quality of the therapeutic alliance and the quality of the therapeutic relationship , as rated by the patient . These results may have important clinical implication s for the early-phase treatment of patients presenting with BPD OBJECTIVE This study aim ed to evaluate the success of implementing outpatient schema focused therapy ( ST ) for borderline patients in regular mental healthcare and to determine the added value of therapist telephone availability outside office hours in case of crisis ( TTA ) . METHODS To enhance the implementation , the following adaptations regarding the original ST protocol were applied : a reduction in the frequency and duration of the therapy ; training therapists of eight regular healthcare centers in ST with a structured and piloted program supported by a set of films ( DVDs ) with examples of ST techniques ; training and supervision given by Dutch experts . Telephone availability outside office hours was r and omly allocated to 50 % of the therapists of each treatment center . Patient 's outcome measures were assessed with a semi-structured interview and self-report measures on BPD , quality of life , general psychopathology and an ST question naire , before , during and after treatment . RESULTS Data on 62 DSM-IV defined BPD patients were available . Intention-to-treat analyses showed that after 1.5 years of ST 42 % of the patients had recovered from BPD . No added value of therapist telephone availability ( TTA ) was found on the BPDSI score nor on any other measure after 1.5 years of ST . CONCLUSIONS ST for BPD can be successfully implemented in regular mental healthcare . Treatment results and dropout were comparable to a previous clinical trail . No additional effect of extra crisis support with TTA outside office hours ST was found BACKGROUND Transference-focused psychotherapy is a manualised treatment for borderline personality disorder . AIMS To compare transference-focused psychotherapy with treatment by experienced community psychotherapists . METHOD In a r and omised controlled trial ( NCT00714311 ) 104 female out- patients were treated for 1 year with either transference-focused psychotherapy or by an experienced community psychotherapist . RESULTS Significantly fewer participants dropped out of the transference-focused psychotherapy group ( 38.5 % v. 67.3 % ) and also significantly fewer attempted suicide ( d = 0.8 , P = 0.009 ) . Transference-focused psychotherapy was significantly superior in the domains of borderline symptomatology ( d = 1.6 , P = 0.001 ) , psychosocial functioning ( d = 1.0 , P = 0.002 ) , personality organisation ( d = 1.0 , P = 0.001 ) and psychiatric in-patient admissions ( d = 0.5 , P = 0.001 ) . Both groups improved significantly in the domains of depression and anxiety and the transference-focused psychotherapy group in general psychopathology , all without significant group differences ( d = 0.3 - 0.5 ) . Self-harming behaviour did not change in either group . CONCLUSIONS Transference-focused psychotherapy is more efficacious than treatment by experienced community psychotherapists in the domains of borderline symptomatology , psychosocial functioning , and personality organisation . Moreover , there is preliminary evidence for a superiority in the reduction of suicidality and need for psychiatric in-patient treatment Background Structured psychotherapy is recommended as the preferred treatment of personality disorders . A substantial group of patients , however , has no access to these therapies or does not benefit . For those patients who have no ( longer ) access to psychotherapy a Collaborative Care Program ( CCP ) is developed . Collaborative Care originated in somatic health care to increase shared decision making and to enhance self management skills of chronic patients . Nurses have a prominent position in CCP 's as they are responsible for optimal continuity and coordination of care . The aim of the CCP is to improve quality of life and self management skills , and reduce destructive behaviour and other manifestations of the personality disorder . Methods / design Quantitative and qualitative data are combined in a comparative multiple case study . This makes it possible to test the feasibility of the CCP , and also provides insight into the preliminary outcomes of CCP . Two treatment conditions will be compared , one in which the CCP is provided , the other in which Care as Usual is offered . In both conditions 16 patients will be included . The perspectives of patients , their informal carers and nurses are integrated in this study . Data ( question naires , documents , and interviews ) will be collected among these three groups of participants . The process of treatment and care within both research conditions is described with qualitative research methods . Additional quantitative data provide insight in the preliminary results of the CCP compared to CAU . With a stepped analysis plan the ' black box ' of the application of the program will be revealed in order to underst and which characteristics and influencing factors are indicative for positive or negative outcomes . Discussion The present study is , as to the best of our knowledge , the first to examine Collaborative Care for patients with severe personality disorders receiving outpatient mental health care . With the chosen design we want to examine how and which elements of the CC Program could contribute to a better quality of life for the patients .Trial registration Netherl and s Trial Register ( NTR ) : A r and omized controlled trial was conducted to determine whether a manual-based psychodynamic treatment , labeled dynamic deconstructive psychotherapy ( DDP ) , would be feasible and effective for individuals with co-occurring borderline personality disorder ( BPD ) and alcohol use disorder . Thirty participants were assessed every 3 months during a year of treatment with either DDP or treatment as usual ( TAU ) in the community . DDP participants showed statistically significant improvement in parasuicide behavior , alcohol misuse , institutional care , depression , dissociation , and core symptoms of BPD , and treatment retention was 67 % to 73 % . Although TAU participants received higher average treatment intensity , they showed only limited change during the same period . The results support the feasibility , tolerability , and efficacy of DDP for the co-occurring subgroup and highlight the need for further research . ( PsycINFO Data base Record ( c ) 2010 APA , all rights reserved ) BACKGROUND Longer-term follow-up of patients with borderline personality disorder have found favourable clinical outcomes , with long-term reduction in symptoms and diagnosis . AIMS We examined the 6-year outcome of patients with borderline personality disorder who were r and omised to 1 year of cognitive-behavioural therapy for personality disorders ( CBT-PD ) or treatment as usual ( TAU ) in the BOSCOT trial , in three centres across the UK ( trial registration : IS RCT N86177428 ) . METHOD In total , 106 participants met criteria for borderline personality disorder in the original trial . Patients were interviewed at follow-up by research assistants masked to the patient 's original treatment group , CBT-PD or TAU , using the same measures as in the original r and omised trial . Statistical analyses of data for the group as a whole are based on generalised linear models with repeated measures analysis of variance type models to examine group differences . RESULTS Follow-up data were obtained for 82 % of patients at 6 years . Over half the patients meeting criteria for borderline personality disorder at entry into the study no longer did so 6 years later . The gains of CBT-PD over TAU in reduction of suicidal behaviour seen after 1-year follow-up were maintained . L
Output:
| The overall efficacy of specific therapies for BPD is promising . |
MS212244 | ***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 Excessive protocol violations ( PV ) , which can be defined as preventable mistakes in study conduct , may result in patient harm and introduce errors into a clinical trial 's results leading to flawed trial conclusions .The purpose of this project was to gain a better underst and ing of reported PVs , to describe current practice with regards to the use of methods for the reduction of PVs and to investigate relationships between clinical trial characteristics and PVs . Methods We review ed 80 clinical trials conducted across a broad range of medical specialties published in four major general medical journals ( The Lancet , NEJM , JAMA , BMJ ) . Eligible papers were identified using a PubMed search . For each included trial , two authors independently abstract ed information on trial characteristics , PV reporting and PV rates and interventions used to reduce PVs . PVs were categorised into one of five distinct types : enrolment , r and omisation , study intervention , patient compliance and data collection errors . Associations between PVs and study characteristics were investigated using logistic regression . Results Eighty clinical trials ( 20 from each journal ) were identified from 101 consecutive PubMed abstract s. The median number of participants was 701 ( range : 20 to 162 , 367 ) and the median number of participating sites was 15 ( range : 1 to 701 ) . Nineteen percent ( 15/80 ) of included trials were single centre trials . The median study duration was 24 months ( range : 5.81 - 127 months ) and 74 % ( 59/80 ) of included trials were primarily academic funded . Thirty two percent ( 26/80 ) of included trials failed to provide explicit reporting of any type of PV and none ( 0/80 ) of the trials provided explicit reporting of all five types of PVs . Larger clinical trials ( more patients , more sites , longer duration , more complex management structure ) were more likely to have more complete reporting of PV's . Only 9 % ( 7/80 ) of trials reported the use of a specific study method to prevent PVs . Use of a run-in phase was the only method reported . Conclusions PVs are under-reported . Although the CONSORT statement provides guidance on the reporting of PVs , reporting requirements are not explicit for all types of PVs . As a first step towards improved reporting by authors , we recommend the CONSORT statement highlight the importance of PVs by making reporting requirements more explicit Background Compliance with Good Clinical Practice ( GCP ) guidelines should ensure the safety of trial participants and the reliability of trial results . Over the last decade , increasing emphasis has been placed on the role of costly on-site monitoring and source data verification as processes to demonstrate that GCP is being followed , despite a lack of empirical evidence that these are effective . Purpose To assess whether findings from on-site monitoring of a recent international multi-centre clinical trial could have been identified using central data review and other central ised monitoring techniques . Methods Findings documented in a sample of site monitoring reports , and Programme Management Board Executive ( PMBe ) reports , from the Microbicides Development Programme ( MDP ) 301 trial – a r and omised placebo-controlled trial of a microbicide gel to prevent vaginally acquired HIV infection conducted in four countries in East and Southern Africa – were extracted and individually assessed to determine whether they could have been detected in the trial data base or through other central means . Results Four site visit reports contained 268 monitoring findings from a review of 104 participant files covering 324 study visits . Of the 268 findings , 76 ( 28.4 % ) were also identified in the study data base . Central checks , had these been in place ( such as central receipt and review of back-translated documents , enrolment and testing logs , informed consent , and more complex data base queries ) , could have identified a further 179 ( 66.8 % ) ; 13 ( 4.9 % ) other findings ( all minor ) could have been identified through a review of the participant folder at site . The four PMBe reports review ed included six major and three critical findings from a review of over 1000 participant files : only two of these ( both major ) were assessed as unlikely to be identified using central monitoring techniques . Limitations The study data used were not collected with this retrospective review in mind . It suggests that prospect i ve work is needed to compare monitoring practice s in real time . Conclusions While there may be some categories of findings that it is not possible to identify central ly , the very large majority of findings review ed in this analysis could be identified using central monitoring strategies . These data suggest that with better central and targeted on-site monitoring , it should be possible to identify and address most protocol and procedural compliance issues without performing intensive and costly routine on-site data monitoring Background Review ing clinical trial site performance identifies strategies to control outcomes . Performance across 5 geographical regions ( 36 sites across Asia , Australia , Europe , North America and Latin America ) was investigated in a study that r and omised 322 HIV-infected individuals . Methods Regional performance was compared using descriptive analysis for time to site opening , recruitment , quality of data and laboratory sample s. Follow-up consisted of 10 visits ( 96 weeks ) , electronic data collection ( EDC ) within 7 days of a visit and serious adverse events ( SAEs ) reported within 24 hours of site awareness . Results Median days to site opening was 250 ( 188 to 266 ) , ranging from 177 ( 158 to 200 ) ( Australia ) to 265 ( 205 to 270 ) ( Europe ) . Median days to ethics and regulatory approval was 182 ( 120 to 241 ) and 218 ( 182 to 341 ) days , respectively . Within regions , time to approval ranged from 187 ( 91 to 205 ) days ( Australia ) to 276 ( 175 to 384 ) days ( Europe ) . Time to first r and omisation ranged from 282 ( 250 to 313 ) days ( Australia ) to 426 ( 420 to 433 ) days ( North America).Recruitment was lower than forecasted in Asia , Australia , Europe and North America at 89 % , 77 % , 91 % and 43 % , respectively . The converse was true in Latin America where despite ethics , regulatory and contractual delays , recruitment was 104 % of predicted . Median days to EDC was 7 ( 3 to 16 ) , ranging from 3 ( 1 to 16 ) ( Asia ) to 13 ( 8 to 14 ) days ( North America ) . Median days for initial SAE su bmi ssion to sponsor was 6 ( 2 to 20 ) , ranging from 4 ( 2 to 18 ) ( Latin America ) to 24 ( 5 to 46 ) days ( Australia ) . Sites took longer to su bmi t final reports , overall median of 28 ( 7 to 91 ) days , ranging from 7 days ( Australia ) to 67 ( 23 to 103 ) days ( Europe ) . Conclusions Population availability and time to ethics and regulatory approvals influence recruitment ; therefore accurate feasibility assessment s are critical to site selection . Time to ethics and regulatory approval may not limit site inclusion if compensated by rapid recruitment . Identifying potential delays and methods for reduction can decrease time and costs for sponsors . Trial registration Clinical Trials . Gov identifier : NCT00335322 . Date of registration : 8 June Background Monitoring in r and omized trials is recommended as part of International Conference on Harmonisation Good Clinical Practice st and ards . On-site monitoring in multicentre trials is common but is costly and can be inefficient . Central statistical monitoring can be used to detect unusual data patterns , identify intentional or unintentional trial misconduct , and to prioritise on-site visits and additional training . Motivated by an ongoing international multicentre clinical trial of over 25,000 r and omized participants with electronic data capture , we developed key risk indicator ( KRI ) methods for central statistical monitoring in multicentre trials Large r and omized trials are required to provide reliable evidence of the typically moderate benefit of most interventions . To be affordable , such trials need to be simple ; to be widely applicable , they need to be close to normal clinical practice . However , current regulations and guidelines have hugely increased trial complexity , effectively becoming barriers to their design and conduct . Key barriers include inadequate funding , overly complex regulations producing needlessly complex trial procedures , excessive monitoring , over restrictive interpretation of privacy laws without evidence of subject benefit , and inadequate underst and ing of methodology . Complex regulations result in multiple ethics approvals for a multi-center study , unnecessary complexity in the study protocol , delays in securing regulatory approval , and cumbersome regulatory procedures , even for drugs widely used in clinical practice . The type of detailed safety monitoring currently needed in trials of new drugs is being applied indiscriminately to all studies including a simpler and basic level of monitoring that constitutes good practice in most trials could be agreed on , with that level being exceeded only in specific instances . More evidence about the pros and cons of alternative approaches to data quality monitoring would help inform this process . Complex procedures in the form of multiple-page consent forms , overzealous monitoring of side effects and adverse events , source data verification , and over-restrictive approaches to protocol amendments , can impede , rather than facilitate , trial objectives . Finally , further education on the nuances and functions of r and omisation would facilitate trial conduct , and reduce the need for burdensome complexity . A radical re-evaluation of existing trial guidelines is needed , based on a clear underst and ing of the important principles of r and omized trials , with the objective of eliminating unnecessary documentation and reporting without sacrificing validity or safety . Research ers should encourage public debate about how best to strike the balance between regulation and cost . Clinical Trials 2008 ; 5 : 40—48 .
Output:
| Conclusions This review identifies a list of metrics to monitor site performance within multicentre r and omised trials . |
MS212245 | ***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: BACKGROUND The limitations of current treatments for postherpetic neuralgia ( PHN ) have led to the investigation of localised , non-systemic alternatives . NGX-4010 , a high-concentration ( 8 % ) capsaicin dermal patch , was developed to treat patients with neuropathic pain . We report the results of a r and omised , double blind , 12-week study of the efficacy and safety of one application of NGX-4010 in patients with PHN . METHODS In this multicentre , double-blind , parallel-group trial , 402 patients were r and omly assigned to one 60-min application of NGX-4010 ( 640 microg/cm(2 ) [ 8 % capsaicin ] ) or a low-concentration capsaicin control patch ( 3.2 microg/cm(2 ) [ 0.04 % capsaicin ] ) . Patients were aged 18 - 90 years , had had postherpetic neuralgia for at least 6 months , and had an average baseline numeric pain rating scale ( NPRS ) score of 3 to 9 . The primary efficacy endpoint was percentage change in NPRS score from baseline to weeks two to eight . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00115310 . FINDINGS Patients who were r and omly assigned to NGX-4010 ( n=206 ) had a significantly greater reduction in pain during weeks two to eight than did patients who had the control patch ( n=196 ) . The mean changes in NPRS score were -29.6%vs -19.9 % ( difference -9.7 % , 95 % CI -15.47 to -3.95 ; p=0.001 ) . 87 ( 42 % ) patients who received NGX-4010 and 63 ( 32 % ) controls had a 30 % or greater reduction in mean NPRS score ( odds ratio [ OR ] 1.56 , 95 % CI 1.03 to 2.37 ; p=0.03 ) . The patients who had NGX-4010 had significant improvements in pain during weeks two to 12 ( mean change in NPRS score -29.9%vs -20.4 % , difference -9.5 , -15.39 to -3.61 ; p=0.002 ) . Transient blood pressure changes associated with changes in pain level were recorded on the day of treatment , and short-lasting erythema and pain at the site of application were common , self-limited , and generally mild to moderate in the NGX-4010 group and less frequent and severe in the controls . INTERPRETATION One 60-min application of NGX-4010 provided rapid and sustained pain relief in patients with postherpetic neuralgia . No adverse events were associated with treatment except for local reactions at the site of application and those related to treatment-associated pain 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 Uncontrolled studies have indicated that topically applied capsaicin may be a safe and effective treatment for postherpetic neuralgia . In a double-blind study 32 elderly patients with chronic postherpetic neuralgia were treated with either capsaicin cream or its vehicle for a 6-week period . Response to treatment was evaluated by visual analogue scales of pain and of pain relief , together with changes in a categoric pain scale and in a physician 's global evaluation . Significantly greater relief in the capsaicin-treated group compared with vehicle was observed for all efficacy variables . After 6 weeks almost 80 % of capsaicin-treated patients experienced some relief from their pain . Because capsaicin avoids problems with drug interactions and systemic toxicity , we suggest that topical capsaicin be considered for initial management of postherpetic neuralgia Eighteen patients with the post-mastectomy pain syndrome ( PMPS ) form the basis of this study . PMPS probably occurs in a minority of women after mastectomy . The onset of persistent pain usually occurred immediately or very shortly after the operation . The pain location or sensory findings implied involvement of the territories of other cutaneous branches of the intercostal nerves as well as the intercostobrachial nerve . A variety of treatment approaches were unsatisfactory . Twelve of 14 patients completing treatment with topical 0.025 % capsaicin showed improvement after 4 weeks and 8 ( 57 % ) were judged to be good or excellent responses . Six months after the trial 's completion 50 % of those followed continued to have good pain relief . This therapy should now be subjected to a r and omized , double-blind , placebo-controlled trial An 8-week , double-blind , vehicle-controlled study was conducted to determine the effectiveness of topical capsaicin 0.075 % cream in relieving pain associated with diabetic neuropathy . Patients were selected who experienced moderate to very severe pain , which interfered with sleep or activities on a daily basis , and who were unresponsive or intolerant to conventional therapy . The results after 8 weeks showed a statistically significant difference in favor of the capsaicin-treated patients , with 90 % of these patients improved . The results of this study indicate that topical capsaicin 0.075 % cream is safe and effective in managing painful diabetic neuropathy 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 We assessed the quality of assessment and reporting of adverse effects in r and omized , double-blind clinical trials of single-dose acetaminophen or ibuprofen compared with placebo in moderate to severe postoperative pain . Reports were identified by systematic search ing of a number of bibliographic data bases ( e.g. , MEDLINE ) . Information on adverse effect assessment , severity and reporting , patient withdrawals , and anesthetic used was extracted . Compliance with former guidelines for adverse effect reporting was noted . Fifty-two studies were included ; two made no mention of adverse effects . No method of assessment was given in 19 studies . Twenty trials failed to report the type of anesthetic used , eight made no mention of patient withdrawals , and nine did not state the severity of reported adverse effects . Only two studies described the method of assessment of adverse effect severity . When all adverse effect data were pooled , significantly more adverse effects were reported with active treatment than with placebo . For individual adverse effects , there was no difference between active ( acetaminophen 1000 mg or ibuprofen 400 mg ) and placebo ; the exception was significantly more somnolence/drowsiness with ibuprofen 400 mg . Ninety percent of trials reporting somnolence/drowsiness with ibuprofen 400 mg were in dental pain . All studies published after 1994 complied with former guidelines for adverse effect reporting . Different methods of assessing adverse effects produce different reported incidence : patient diaries yielded significantly more adverse effects than other forms of assessment . We recommend guidelines for reporting adverse effect information in clinical trials PURPOSE A minority of cancer survivors develops long-term postsurgical neuropathic pain . Based on evidence that capsaicin , the pungent ingredient in hot chili peppers , might be useful for treating neuropathic pain , we developed the present clinical trial . PATIENTS AND METHODS Ninety-nine assessable patients with postsurgical neuropathic pain were entered onto this study . After stratification , patients were to receive 8 weeks of a 0.075 % capsaicin cream followed by 8 weeks of an identical-appearing placebo cream , or vice versa . A capsaicin/placebo cream was to be applied to the painful site four times daily . Treatment evaluation was performed by patient-completed weekly question naires . RESULTS During the first 8-week study period , the capsaicin-cream arm was associated with substantially more skin burning , skin redness , and coughing ( P < .0001 for each ) . Nonetheless , treatment was stopped for patient refusal or toxicity just as often while patients were receiving the placebo as compared with the capsaicin . The capsaicin cream arm had substantially more pain relief ( P = .01 ) after the first 8 weeks , with an average pain reduction of 53 % versus 17 % . On completion of the 16-week study period , patients were asked which treatment period was most beneficial . Of the responding patients , 60 % chose the capsaicin arm , 18 % chose the placebo arm , and 22 % chose neither ( P = .001 ) . CONCLUSION A topical capsaicin cream decreases postsurgical neuropathic pain and , despite some toxicities , is preferred by patients over a placebo by a three-to-one margin among those expressing a preference Distal symmetrical peripheral neuropathy ( DSPN ) is a particularly distressing pain syndrome associated with human immunodeficiency virus ( HIV ) disease . Capsaicin has been found to be effective in relieving pain associated with other neuropathic pain syndromes , and is mentioned as a possible topical adjuvant analgesic for the relief of DSPN . This multicenter , controlled , r and omized , double-masked clinical trial studied patients with HIV-associated DSPN and compared measures of pain intensity , pain relief , sensory perception , quality of life , mood , and function for patients who received topical capsaicin to the corresponding measures for patients who received the vehicle only . Twenty-six subjects were enrolled in the study . At the end of 1 week , subjects receiving capsaicin tended to report higher current pain scores than did subjects receiving the vehicle ( Mann-Whitney test ; P = 0.042 ) . The dropout rate was higher for the capsaicin group ( 67 % ) than for the vehicle group ( 18 % ) ( chi 2 test of association ; P = 0.014 ) . There were no other statistically significant differences between the capsaicin and vehicle groups with respect to current pain , worst pain , pain relief , sensory perception , quality of life , mood , or function at study entry or at any time during the 4-week trial . These results suggest capsaicin is ineffect
Output:
| Capsaicin , either as repeated application of a low dose ( 0.075 % ) cream , or a single application of a high dose ( 8 % ) patch may provide a degree of pain relief to some patients with painful neuropathic conditions .
Local skin irritation , which is often mild and transient but may lead to withdrawal , is common .
Systemic adverse effects are rare . |
MS212246 | ***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: A classical treatment for chronic adult periodontitis consists of four to six consecutive sessions of scaling and root planing at a 1- to 2-week interval . Such a so-called " quadrant or sextant therapy " might result in a reinfection of a previously disinfected area by bacteria from an untreated region . The purpose of this study was to investigate , over an 8-month period , the clinical benefits of full-mouth disinfection within a 24-hour period in the control of chronic periodontitis . Ten adult patients with advanced chronic periodontitis were r and omly assigned to a test and a control group . The control group received the st and ard scheme of initial periodontal therapy , consisting of scaling and root planing of the four quadrants was performed within 24 hours and immediately followed by a thorough supra- and subgingival chlorhexidine application to limit any transfer of bacteria . The latter involved tongue brushing with a 1 % chlorhexidine gel for 60 seconds , mouthrinsing with a 0.2 % chlorhexidine solution twice for 60 seconds , repeated subgingival irrigation of all pockets with a 1 % chlorhexidine gel ( 3 times within 10 minutes ) , and mouthrinsing twice daily with a 0.2 % chlorhexidine solution during 2 weeks . In addition , both groups received thorough oral hygiene instructions . The plaque index , gingival index , probing depth , gingival recession , and bleeding on probing were recorded prior to professional cleaning and at 1 , 2 , 4 , and 8 months afterwards . Although the test group scored higher plaque indices than the control group , especially at months 2 and 4 , the gingival index and bleeding tendency showed similar improvements with time . However , when the gingival/plaque ratio was considered , the latter was lower in the test group at all follow-up visits . For pockets > or = 7 mm , full-mouth disinfection showed a significantly ( P = 0.01 ) higher reduction in probing depth at each follow-up visit with , at month 8 , a reduction of 4 mm ( from 8 mm to 4 mm ) , in comparison to 3 mm ( from 8 mm to 5 mm ) for the classical therapy . The increase in gingival recession in the full-mouth disinfection group remained below 0.7 mm , while in the control group it reached 1.9 mm after 8 months . This result ed in a gain of clinical attachment level of 3.7 mm for the test group versus 1.9 mm for the control group . A radiographical examination also indicated a superior improvement for the test group when compared to the control group . This pilot study suggests that a full-mouth disinfection in one day results in an improved clinical outcome in chronic periodontitis as compared to scalings per quadrant at 2-week intervals over several weeks A treatment for periodontal infections often consists of consecutive rootplanings ( per quadrant , at a 1- to 2-week interval ) , without a proper disinfection of the remaining intra-oral niches ( untreated pockets , tongue , saliva , mucosa and tonsils ) . Such an approach , could theoretically lead to a reinfection of previously-treated pockets . The present study aims to examine the effect of a full-mouth disinfection on the microbiota in the above-mentioned niches . Moreover , the clinical benefit of such an approach was investigated . 16 patients with severe periodontitis were r and omly allocated to a test and a control group . The patients from the control group were scaled and rootplaned , per quadrant , at 2-week intervals and obtained oral hygiene instructions . The patients from the test group received a full-mouth disinfection consisting of : scaling and rootplaning of all pockets in 2 visits within 24 h , in combination with tongue brushing with 1 % chlorhexidine gel for 1 min , mouth rinsing with a 0.2 % chlorhexidine solution for 2 min and subgingival irrigation of all pockets ( 3x in 10 min ) with 1 % chlorhexidine gel . Besides oral hygiene , the test group rinsed 2x daily with 0.2 % chlorhexidine and sprayed the tonsils with a 0.2 % chlorhexidine for 2 months . Plaque sample s ( pockets , tongue , mucosa and saliva ) were taken at baseline and after 2 and 4 months , and changes in probing depth , attachment level and bleeding on probing were reported . The full-mouth disinfection result ed in a statistically significant additional reduction/elimination of periodontopathogens , especially in the subgingival pockets , but also in the other niches . These microbiological improvements were reflected in a statistically-significant higher probing depth reduction and attachment gain in the test patients . These findings suggest that a disinfection of all intra-oral niches within a short time span leads to significant clinical and microbiological improvements for up to 4 months OBJECTIVES The beneficial effects of the one-stage , full-mouth disinfection remain controversial in the scientific literature . This might be due to the fact that an entire mouth disinfection with the use of antiseptics has been confused with a full-mouth scaling and root planing . This parallel , single blind RCT study aim ed to compare several full-mouth treatment strategies with each other . MATERIAL AND METHODS Seventy-one patients with moderate periodontitis were r and omly allocated to one of the following treatment strategies : scaling and root planing , quadrant by quadrant , at two-week intervals ( negative control , NC ) , full-mouth scaling and root planing within 2 consecutive days ( FRP ) , or three one-stage , full-mouth disinfection ( FM ) protocol s within 2 consecutive days applying antiseptics to all intra-oral niches for periopathogens using as antiseptics : chlorhexidine ( FMCHX ) for 2 months , amine fluoride/stannous fluoride for 2 months ( FMF ) , or chlorhexidine for 2 months followed by amine fluoride/stannous fluoride for another 6 months ( FMCHX+F ) . At baseline and after 2 , 4 , and 8 a series of periodontal parameters were recorded . RESULTS All treatment strategies result ed in significant ( p<0.05 ) improvements of all clinical parameters over the entire duration of the study . Inter-treatment differences were often encountered . The NC group nearly always showed significant smaller improvements than the two CHX groups . The differences between the FRP or FM groups , and the two CHX groups only sporadically reached a statistical significance . CONCLUSION These observations indicate that the benefits of the " OSFMD " protocol are partially due to the use of the antiseptics and partially to the completion of the therapy in a short time Previous studies using correlation or regression analysis have showed that treatment effects measured by the change in clinical parameters are often associated with baseline values of the same parameters . These studies , however , have a method ological weakness . Correlation/regression between baseline measures and the derived change variable invali date s the statistical procedures of testing the null hypothesis : that the coefficient of correlation/regression is zero . This is due to the phenomenon of mathematical coupling . To investigate the impact that this has on the observed correlation/regression coefficient when in reality this is zero , we used r and om simulations of hypothetical data to model the treatment of periodontal pockets . Results showed a strong probability of obtaining statistically significant correlation/regression coefficients . To separate this artificial effect of mathematical coupling from the true underlying biological relationship , one must apply appropriate analytical strategies to re-evaluate previous evidence within the periodontal literature BACKGROUND / AIMS Recent studies reported significant additional clinical and microbiological improvements when severe adult periodontitis was treated by means of a " one-stage full-mouth " disinfection instead of a st and ard treatment strategy with consecutive root planings quadrant per quadrant . The one stage full-mouth disinfection procedure involves scaling and root planing of all pockets within 24 h in combination with an extensive application of chlorhexidine to all intra-oral niches such as periodontal pockets , tongue dorsum , tonsils ( chairside , and at home for 2 months ) . This study aims to examine the relative importance of the use of chlorhexidine in the one stage full-mouth disinfection protocol . METHODS Therefore , 3 groups of 12 patients each with advanced periodontitis were followed , both from a clinical and microbiological point of view , over a period of 8 months . The patients from the control group were scaled and root planed , quadrant per quadrant . at two-week intervals . The 2 other groups underwent a one stage full-mouth scaling and root planing ( all pockets within 24 h ) with ( Fdis ) or without ( FRp = full-mouth root planing ) the adjunctive use of chlorhexidine . At baseline and after 1 , 2 , 4 and 8 months , the following clinical parameters were recorded : plaque and gingivitis indices , probing depth , bleeding on probing and clinical attachment level . Microbiological sample s were taken from different intra-oral niches ( tongue , mucosa , saliva and pooled sample s from single- and multi-rooted teeth ) . The sample s were cultured on selective and non-selective media in order to evaluate the number of CFU/ml for the key-periodontopathogens . At baseline , an anonymous question naire was given to the patients to record the perception of each treatment ( post operative pain , fever , swelling etc . ) . RESULTS All 3 treatment strategies result ed in significant improvements for all clinical parameters , but the Fdis and FRp patients reacted always significantly more favourably than the control group , with an additional probing depth reduction of + /- 1.5 mm and an additional gain in attachment of + /- 2 mm ( for pockets > or = 7 mm ) . Also from a microbiological point of view both the FRp and Fdis patients showed additional improvements when compared to the control group , as well in the reduction of spirochetes and motile organisms as in the number of CFU/ml of the key-pathogens , especially when the subgingival plaque sample s were considered . The differences between FRp and Fdis patients were negligible . CONCLUSIONS These findings suggest that the benefits of a " one-stage full-mouth disinfection " in the treatment of patients suffering from severe adult periodontitis probably results from the full-mouth scaling and root planing within 24 h rather than the beneficial effect of chlorhexidine . The raise in body temperature the second day after the full-mouth scaling and root planing seems to indicate a Shwartzman reaction OBJECTIVES The aim of this study was to determine whether same-day full-mouth scaling and root planing ( FM-SRP ) and quadrant scaling and root planing ( Q-SRP ) result ed in variations in the systemic humoral immune response dynamics ( antibody titres and avidity ) during active treatment and 3 and 6 months post-therapy . MATERIAL S AND METHODS Forty patients with chronic periodontitis were recruited into this study . Subjects were r and omised into two groups and received either scaling and root planing quadrant by quadrant at 2-weekly intervals ( Q-SRP group ) or same-day full-mouth scaling and root planing ( FM-SRP group ) . Clinical measurements and serum sample s were obtained at baseline and approximately 6 weeks after the last clinical intervention ( R1 ) and 6 months after the initiation of therapy ( R2 ) . Furthermore , serum sample s were obtained from each patient undergoing therapy ( Q-SRP and FM-SRP ) at 3 bi-weekly instances so as to determine the short-term effects of each session of scaling and root planing on the dynamics of the humoral immune response . Serum antibody titre was assayed by enzyme-linked immunosorbent assay ( ELISA ) and antibody avidity was measured by thiocyanate dissociation against five putative periodontal pathogens : Porphyromonas gingivalis ; Actinobacillus actinomycetemcomitans ; Prevotella intermedia ; Treponema denticola and Bacteroides forsythus . RESULTS Both therapies result ed in similar antibody titre reductions against the majority of the organisms tested and although there was a distinct trend for antibody avidity to increase following therapy , this was not found to be statistically significant , reflecting marked inter-individual variation . In addition , no evidence emerged from this study to support increased antibody titres following the active phases of both treatment approaches due to an inoculation effect . Nevertheless , significant short-term increases in antibody avidity to most test bacteria were noted for both treatment strategies . CONCLUSION Both therapies were associated with a reduction in antibody titres and an increase in the binding ability or avidity of antibodies , but there was a marked inter-subject variability and statistical significance was reached for only some of the test bacteria . No significant differences in the humoral antibody dynamics were found between the two treatment approaches BACKGROUND The aim of the present study was to evaluate the effectiveness of non-surgical mechanical instrumentation at 2 different time intervals on short-term healing and to assess patient reactions following non-surgical periodontal therapy . METHODS The study population consisted of 100 patients with moderate periodontal disease . Patients were equally distributed into 2 groups , treated daily or weekly . The daily group received full-mouth daily scaling and root planing for 4 consecutive days . The weekly group was treated once a week for 4 weeks . All patients were asked for objective ( lymphadenopathy , aphthous stomatitis , and edema ) and subjective ( fatigue , pain , pruritus , burning sensation , and dentinalgia ) reactions . Clinical measurements of plaque index ( PI ) , gingival index ( GI ) , probing depth ( PD ) , bleeding on probing ( BOP ) , and gingival recession ( GR ) were taken at baseline and 3 months after treatment . All of the objective and subjective reactions were recorded after each treatment session . RESULTS The results of our study revealed a significant decrease in PI , GI , BOP , and PD measurements at the end of the third month , but no significant changes in GR . The incidence of subjective and objective reactions was higher in the daily treated group compared to those in the weekly group . Most of these complaints were observed after the third treatment session . CONCLUSIONS Within the limits of this study , no differences were observed between the study groups when the clinical parameters were evaluated .
Output:
| CONCLUSIONS In adults with chronic periodontitis only minor differences in treatment effects were observed between the treatment strategies |
MS212247 | ***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 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 Abstract A previously established relationship for deriving dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics has been tested using an independent data set . Individual patient information from 18 RCTs of parallel‐group design in acute postoperative pain ( after abdominal , gynaecological and oral surgery ) was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with > 50%maxTOTPAR for the different treatments . The relationship between the measures was investigated in 85 treatments with over 3400 patients . In 80 of 85 treatments ( 94 % ) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 ( 85 % ) was within three ( average of 40 patients per treatment , range 21–58 patients ) . Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm . Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events , such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic review s which require data in dichotomous form & NA ; Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events — such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data , at least in acute pain models , indicates that more meaningful overviews or meta‐ analysis may be possible . This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data , and then used that relationship to derive dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics . Individual patient information from 13 RCTs of parallel‐group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with greater than 50 % pain relief ( > 50%maxTOTPAR ) for the different treatments . The relationship between the measures was investigated in 45 actual treatments and 10 000 treatments simulated using the underlying actual distribution ; 1283 patients had 45 separate treatments . Mean % maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR ( r2 = 0.90 ) . The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50 % pain relief in 42 of 45 treatments , and 98.8 % of 10 000 simulated treatments . For seven effective treatments , actual numbers‐needed‐to‐treat ( NNT ) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data & NA ; A data base of r and omised clinical trials ( RCTs ) in pain research published from 1950 to 1990 was created following an extensive literature search . By applying a refined MEDLINE search strategy from 1966 to 1990 and by h and ‐ search ing more than 1 000 000 pages of a total of 40 biomedical journals published during the period 1950–1990 , more than 8000 RCTs were identified . The RCTs were published in more than 800 journals and over 85 % appeared between 1976 and 1990 . If the trend of the last 15 years persists , a total of more than 15 000 RCTs will be published in pain relief by the year 2000 . A detailed description of methods to ensure efficient use of re sources during the identification , retrieval and management of the information in pain relief and other fields is given . Emphasis is made on the importance of refining MEDLINE search strategies , on the use of volunteers to h and ‐ search journals and on careful monitoring of each of the steps of the process . The potential uses of the data base to guide clinical and research decisions are discussed The effect of 5 days ' treatment with indomethacin , acemethacin and proglumethacin on the gastroduodenal mucosa was endoscopically evaluated in healthy volunteers . In a r and omised double-blind crossover system 16 subjects received 50 mg t.i.d . indomethacin and 60 mg t.i.d . acemethacin , and a further 16 volunteers received 50 mg t.i.d . indomethacin and 150 mg t.i.d . proglumethacin . After 5 days both proglumethacin and acemethacin caused significantly less gastroduodenal lesions than indomethacin . Possible reasons for the apparently better gastro-duodenal tolerability of both indomethacin derivatives are discussed Abstract One way to ensure adequate sensitivity for analgesic trials is to test the intervention on patients who have established pain of moderate to severe intensity . The usual criterion is at least moderate pain on a categorical pain intensity scale . When visual analogue scales ( VAS ) are the only pain measure in trials we need to know what point on a VAS represents moderate pain , so that these trials can be included in meta‐ analysis when baseline pain of at least moderate intensity is an inclusion criterion . To investigate this we used individual patient data from 1080 patients from r and omised controlled trials of various analgesics . Baseline pain was measured using a 4‐point categorical pain intensity scale and a pain intensity VAS under identical conditions . The distribution of the VAS scores was examined for 736 patients reporting moderate pain and for 344 reporting severe pain . The VAS scores corresponding to moderate or severe pain were also examined by gender . Baseline VAS scores recorded by patients reporting moderate pain were significantly different from those of patients reporting severe pain . Of the patients reporting moderate pain 85 % scored over 30 mm on the corresponding VAS , with a mean score of 49 mm . For those reporting severe pain 85 % scored over 54 mm with a mean score of 75 mm . There was no difference between the corresponding VAS scores of men and women . Our results indicate that if a patient records a baseline VAS score in excess of 30 mm they would probably have recorded at least moderate pain on a 4‐point categorical scale
Output:
| In the absence of r and omised evidence of efficacy for oral acemetacin in acute postoperative pain , we can not , at present , make any conclusions regarding its effectiveness . |
MS212248 | ***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: Music is a method nurses can use to help relieve pain , however little is known about its effectiveness across cultures . In this study , Western music was tested for its effectiveness in reducing postoperative pain in 38 Taiwanese patients , and its acceptability was explored . A pretest and post-test experimental design was used with visual analogue scales to measure sensation and distress of pain . Before surgery , subjects were r and omly assigned to receive tape recorded music or the usual care . Those who were assigned to the music group chose among 5 types of sedative music . On postoperative Day 1 and Day 2 , the effectiveness of the tape-recorded music was investigated during 15 minutes of rest in bed . Patients were interviewed on Day 3 to determine their liking for the music , its calming effects , and the helpfulness of the music . Repeated measures analysis of variance showed a significant interaction between time and group in the distress of pain on Day 1 , but not on Day 2 , and in pain sensation on Day 2 , but not Day 1 . Subjects from Taiwan were similar to subjects in a previous study in the United States in their liking for the music , and in reports of the helpfulness of the music for pain sensation and distress , but fewer Taiwanese found the music calming , and they had different choices : more chose harp music and fewer chose jazz than subjects in the U.S. study , and some would prefer Buddhist hymns or popular songs heard in Taiwan . Findings support the use of culturally acceptable music in addition to analgesic medication for the sensation and distress of postoperative pain BACKGROUND The conduct of r and omized , controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports . OBJECTIVE To develop an extension of the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement for trials of nonpharmacologic treatments . DESIGN A consensus meeting was organized to develop an extension of the CONSORT Statement that addresses r and omized trials of nonpharmacologic treatments . To prepare for the meeting , a survey was conducted to identify the specific issues for discussion . SETTING Consensus meeting in Paris , France . PARTICIPANTS A total of 33 experts attended the meeting . The experts were method ologists ( n = 17 ) ; surgeons ( n = 6 ) ; editors ( n = 5 ) ; and clinicians involved in rehabilitation ( n = 1 ) , psychotherapy ( n = 2 ) , education ( n = 1 ) , and implantable devices ( n = 1 ) . MEASUREMENTS Experts indicated which of the 22 items on the CONSORT checklist should be modified or which additional items should be added specifically for nonpharmacologic treatments . During a 3-day consensus meeting , all items were discussed and additional method ological issues related to nonpharmacologic research were identified . RESULTS The consensus was that 11 items on the CONSORT checklist needed some modifications for nonpharmacologic trials : item 1 ( title and abstract ) , item 3 ( participants ) , item 4 ( interventions ) , item 7 ( sample size ) , item 8 ( r and omization ) , item 11 ( blinding ) , item 12 ( statistical methods ) , item 13 ( participant flow ) , item 15 ( baseline data ) , item 20 ( discussion : interpretation ) , and item 21 ( generalizability ) . In addition , the meeting participants added 1 item related to implementation of the intervention . LIMITATION Evidence was not always available to support the inclusion of each checklist item . CONCLUSION The methods and processes used to develop this extension could be used for other reporting guidelines . The use of this extension to the CONSORT Statement should improve the quality of reporting r and omized , controlled trials assessing nonpharmacologic treatments BACKGROUND Postoperative pain and anxiety are common in cardiac surgery patients . Studies have suggested that music can decrease anxiety in hospitalized patients . Primary Study Objective This study focused on the efficacy and feasibility of special music , which included nature sounds , for pain and anxiety . METHODS / DESIGN In this r and omized controlled trial , postoperative cardiovascular surgery patients were r and omly assigned to a music group to receive 20 minutes of st and ard postoperative care and music twice daily on postoperative days 2 through 4 or to a control group to receive 20 minutes of st and ard care with a quiet resting period twice daily on postoperative days 2 through 4 . SETTING Cardiovascular surgical unit of Saint Marys Hospital , Rochester , Minnesota . PARTICIPANTS One hundred patients completed the study ( music group , n = 49 ; control group , n = 51 ) . Intervention The music was delivered through CD players in the patients ' rooms . PRIMARY OUTCOME MEASURES Pain , anxiety , satisfaction , and relaxation were evaluated from visual analog scales . RESULTS Data showed a significant decrease in mean ( SD ) pain scores after the second session of day 2 for the music group ( change , ? 1.4 [ 1.4 ] ) compared with the control group ( change , ? 0.4 [ 1.4 ] ) ( P = .001 ) . Mean relaxation scores improved more at the first session of day 2 for the music group ( change , 1.9 [ 2.7 ] ) compared with the control group ( change , 0.3 [ 2.9 ] ) ( P = .03 ) . The music group also showed lower anxiety and increased satisfaction overall , but these differences were not statistically significant . No major barriers to using the therapy were identified . CONCLUSION Recorded music and nature sounds can be integrated into the postoperative care of cardiovascular surgery patients . The recordings may provide an additional means for addressing common symptoms of pain and anxiety while providing a means of relaxation for these patients Background : The instability of cardiovascular indices and anxiety disorders are common among patients undergoing coronary artery bypass graft ( CABG ) and could interfere with their recovery . Therefore , improving the cardiovascular indices and anxiety is essential . Objectives : This study aim ed to investigate the effect of music therapy on anxiety and cardiovascular indices in patients undergoing CABG . Patients and Methods : In this r and omized controlled trial , 60 patients hospitalized in the cardiovascular surgical intensive care unit of Shahid Beheshti Hospital in Qom city , Iran , in 2013 were selected using a consecutive sampling method and r and omly allocated into the experimental and control groups . In the experimental group , patients received 30 minutes of light music , whereas in the control group , patients had 30 minutes of rest in bed . The cardiovascular indices and anxiety were measured immediately before , immediately after and half an hour after the study . Data were analyzed using the chi-square test and repeated measures analysis of variance . Results : Compared to the immediately before intervention , the mean anxiety scores immediately after and 30 minutes after the intervention were significantly lower in the experimental group ( P < 0.037 ) while it did not significantly change in the control group . However , there were no significant differences regarding the cardiovascular indices in the three consecutive measurements ( P > 0.05 ) . Conclusions : Music therapy is effective in decreasing anxiety among patients undergoing CABG . However , the intervention was not effective on cardiovascular indices . Music can effectively be used as a non-pharmacological method to manage anxiety after CABG 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 Many patients in the Surgical Holding Area become stressed and anxious . In a hospital setting music reduces patients ' anxiety . This study determined that music can reduce the anxiety and stress of patients in the Surgical Holding Area . In this study , one group of subjects listed to music while a second group did not . Subjects who listened to music while in the Surgical Holding Area had significantly less stress and anxiety than did those who did not listen to music . Both groups spent similar lengths of time in the Surgical Holding Area . The results strongly suggest that if music were available to all patients in the Surgical Holding Area , most would select this option , and they would experience less anxiety Background Due to the strong reduction in the length of hospital stays in the last decade , the period of in-hospital postoperative care is limited . After discharge from the hospital , guidance and monitoring on recovery and resumption of ( work ) activities are usually not provided . As a consequence , return to normal activities and work after surgery is hampered , leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption . Objective With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures , leading to accelerated recovery and to a reduction in costs in comparison to usual care . Methods This is a multicenter r and omized , single-blinded , controlled trial . At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy , inguinal hernia surgery , or laparoscopic adnexal surgery for a benign indication will be included . Patients will be r and omized to an intervention or control group . The intervention group will have access to an innovative , perioperative eHealth care program . This intervention program consists of a website , mobile phone app , and activity tracker . It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery . The control group will receive usual care and will have access to a nonintervention ( st and ard ) website consisting of the digital information brochure about the surgical procedure being performed . Patients are asked to complete question naires at 5 moments during the first 6 months after surgery . The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System ( PROMIS ) physical functioning item bank version 1.2 . Secondary outcomes include social participation , self-rated health , duration of return to work , physical activity , length of recovery , pain intensity , and patient satisfaction . In addition , an economic evaluation alongside this r and omized controlled trial will be performed from the societal and health care perspective . All statistical analyses will be conducted according to the intention-to-treat principle . Results The enrollment of patients started in September 2015 . The follow-up period will be completed in February 2017 . Data cleaning and analyses have not begun as of the time this article was su bmi tted . Conclusions We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower . Clinical Trial Netherl and s Trial Registry NTC4699 ; http://www.trialregister.nl/trialreg/admin/ rct view.asp?TC=4699 ( Archived by WebCite at http://www.webcitation.org/6mcCBZmwy Background : Music , as a non-pharmacological and inexpensive nursing intervention , can be used easily as a complementary technique in reducing pain along with other methods . While some studies have demonstrated pain to decrease after music , others found music to be ineffective on pain . Objectives : The aim of this study was to investigate the effect of music on postoperative pain in patients under open heart surgery . Patients and Methods : A quasi-experimental study was performed on 60 patients under open heart surgery referred to ICU of Shahid Beheshti hospital in Kashan city . Patients were r and omly divided into two groups including experimental and control groups . Patients in music group listened to nonverbal music for 30 minutes after surgery by headphones . The control group did not receive any intervention other than routine care . Before and after intervention , pain intensity was measured and recorded by visual analog scale in two groups . Data was analyzed using Chi-Square and t-tests . Results : Before intervention , the mean of pain intensity was 6.32 ± 0.21 and 6.10 ± 0.21 for experimental and control groups , respectively ; and the difference was not significant ( P = 0.21 ) . After intervention , the mean of pain intensity was 3.11 ± 0.12 and 5.81 ± 0.38 for experimental and control groups , respectively ; and the difference was significant ( P = 0.04 ) . Conclusions : Listening to the relaxant music can reduce postoperative pain . It is suggested that relaxant music be used as a complementary method in patients in order to reduce prospect i ve pain BACKGROUND High levels of anxiety during surgery are associated with poorer post-surgical outcomes . This prospect i ve , non-blinded r and omized controlled trial aim ed to compare the effectiveness of four intraoperative distraction interventions for anxiety and pain management during minimally invasive venous surgery under local anaesthetic . METHODS 407 patients presenting with varicose veins at a private clinic , were r and omized to one of four intraoperative distraction interventions or treatment as usual . All participants received endovenous thermoablation and /or phlebectomies of varicose veins . After losses to follow-up , 398 participants were entered into the analysis . Participants were r and om
Output:
| Metaregression analysis found no significant association between the effect of music interventions and age , sex , choice and timing of music , and type of anaesthesia .
CONCLUSION Music interventions significantly reduce anxiety and pain in adult surgical patients |
MS212249 | ***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: Repeated ingestion of insulin has been suggested as an immune tolerization therapy to prevent immune-mediated ( type 1 ) diabetes . We performed a placebo-controlled , two-dose , oral insulin tolerance trial in newly diagnosed ( < 2 years ) diabetic patients who had required insulin replacement for less than 4 weeks and were found to have cytoplasmic islet cell autoantibodies ( ICAs ) . No oral hypoglycemic agents were permitted during the trial . Endogenous insulin reserves were estimated at six-month intervals by plasma C-peptide responses to a mixed meal . Positive ICAs were found in 262 ( 31 % ) of the 846 patients screened . Of the 197 who agreed to participate , 187 could be followed for 6 to 36 months . Endogenous insulin retention was dependent upon initial stimulated C-peptide response , age at diabetes onset , and numbers of specific islet cell autoantibodies found . Oral insulin improved plasma C-peptide responses in patients diagnosed at ages greater than 20 years , best seen at the low ( 1 mg/day ) over the high ( 10 mg/day ) insulin dose ( P = .003 and P = .01 , respectively ) . In patients diagnosed before age 20 years , the 1 mg dose was ineffective , whereas the 10 mg dose actually accelerated C-peptide loss ( P = .003 ) . There were no adverse effects . If confirmed , these findings suggest that diabetic patients over age 20 years with ICA evidence of late-onset immune-mediated diabetes should be considered for oral insulin at 1 mg/day to better retain endogenous insulin secretion Aims /hypothesis . Induction of tolerance to insulin is achievable in animal models of Type I ( insulin-dependent ) Diabetes mellitus by oral treatment with this hormone , which can lead to prevention of the disease . In the Diabetes Prevention Trial of Type I diabetes ( DPT-1 ) , oral insulin is given with the aim of preventing disease insurgence . We investigated whether if given at diagnosis of Type I diabetes in humans , oral insulin can still act as a tolerogen and therefore preserve residual beta-cell function , which is known to be substantial at diagnosis . Methods . A double-blind trial was carried out in patients ( mean age ± SD : 14 ± 8 years ) with recent-onset Type I diabetes to whom oral insulin ( 5 mg daily ) or placebo was given for 12 months in addition to intensive subcutaneous insulin therapy . A total of 82 patients with clinical Type I diabetes ( < 4 weeks duration ) were studied . Basal C peptide and glycated haemoglobin were measured and the insulin requirement monitored every 3 months up to 1 year . Insulin antibodies were also measured in 27 patients treated with oral insulin and in 18 patients receiving placebo at the beginning of the trial and after 3 , 6 and 12 months of treatment . Results . The trial was completed by 80 patients . Overall and without distinction between age at diagnosis , at 3 , 6 , 9 and 12 months baseline mean C-peptide secretion in patients treated with oral insulin did not differ from that of those patients treated with placebo . In patients younger than 15 years a tendency for lower C-peptide values at 9 and 12 months was observed in the oral insulin group . Insulin requirement at 1 year was similar between the two groups as well as the percentage of glycated haemoglobin . Finally , IgG insulin antibodies were similar in the two groups at each time point . Conclusion /interpretation . The results of this study indicate that the addition of 5 mg of oral insulin does not modify the course of the disease in the first year after diagnosis and probably does not statistically affect the humoral immune response against insulin . [ Diabetologia ( 2000 ) 43 : 1000–1004 OBJECTIVE The objectives of this exploratory study were to assess the postpr and ial glucose-lowering effects and evaluate the safety and tolerability of single , escalating doses of an oral insulin product , hexyl-insulin monoconjugate 2 ( HIM2 ) , in patients with type 2 diabetes . Subcutaneous insulin and oral placebo were also administered for comparison . RESEARCH DESIGN AND METHODS Eighteen patients with type 2 diabetes were enrolled in this r and omized , single-blind , placebo-controlled , three-way crossover , dose-escalation study . A single dose of each of the following study drugs was administered to each patient on 3 separate days : oral HIM2 ( at one of three dose levels : 0.375 , 0.5 , or 1.0 mg/kg ) , subcutaneous regular insulin ( 8 units Humulin R ) , and oral placebo . At 30 min after dosing , patients ingested a st and ardized test meal ( 16 oz/720 calories of Boost Plus ) . Serial blood sample s were collected for determination of plasma glucose and insulin concentrations during the 4-h postdose period . RESULTS The mean glucose area under the curve for 0 to 240 min ( AUC(0 - 240 ) ) values were lower following administration of 0.5 and 1.0 mg/kg HIM2 vs. placebo ( 1,097.1 vs. 1,196.9 and 801.1 vs. 992.1 mg x h(-1 ) x dl(-1 ) , respectively ) . This difference was statistically significant at the 1.0-mg/kg HIM2 dose level . Insulin exposure , as measured by insulin AUC(0 - 240 ) values , for the 0.375- , 0.5- , and 1.0-mg/kg dose levels of HIM2 were 169.9 , 193.1 , and 230.8 micro U x h(-1 ) x ml(-1 ) , respectively ; insulin AUC(0 - 240 ) values for placebo were 165.8 , 196.1 , and 169.2 micro U x h(-1 ) x ml(-1 ) , respectively . The mean glucose AUC(0 - 240 ) values were similar following administration of 0.5 and 1.0 mg/kg HIM2 vs. subcutaneous insulin ( 1,097.1 vs. 1,048.0 and 801.1 vs. 875.2 mg x h(-1 ) x dl(-1 ) , respectively ) . For pooled data from the 0.5- and 1.0-mg/kg dose groups , the HIM2/subcutaneous insulin ratios for the 2-h postpr and ial glucose concentration ( 0.97 , 95 % CI 0.90 - 1.06 ) , maximum postpr and ial glucose concentration ( 0.99 , 95 % CI 0.93 - 1.06 ) , and glucose AUC(0 - 240 ) ( 0.98 , 95 % CI 0.9 - 1.06 ) were within 10 % of unity , implying glucodynamic equivalence . Although HIM2 ( 0.5 and 1.0 mg/kg ) and subcutaneous insulin ( 8 units ) provided comparable control of postpr and ial plasma glucose concentrations , HIM2 result ed in peripheral insulin concentrations that were lower than subcutaneous insulin ( mean insulin AUC(0 - 240 ) of 193.1 vs. 233.6 and 230.8 vs. 270.3 micro U x h(-1 ) x ml(-1 ) , respectively ) . CONCLUSIONS Single , oral doses of HIM2 were safe and well tolerated . HIM2 ( 0.5 and 1.0 mg/kg ) was more effective than placebo and as effective as subcutaneous regular insulin ( 8 units ) at controlling postpr and ial glycemia with respect to the following parameters : 2-h postpr and ial glucose concentration , maximum glucose concentration , and glucose AUC(0 - 240 ) . This occurred even though peripheral insulin concentrations were lower following the administration of HIM2 ( 0.5 and 1.0 mg/kg ) than subcutaneous insulin . Thus , HIM2 therapy may control postpr and ial glycemia without causing peripheral hyperinsulinemia in patients with type 2 diabetes The unpredictable behavior of uncontrolled type 1 diabetes often involves frequent swings in blood glucose levels that impact maintenance of a daily routine . An intensified insulin regimen is often unsuccessful , while other therapeutic options , such as amylin analog injections , use of continuous glucose sensors , and islet or pancreas transplantation are of limited clinical use . In efforts to provide patients with a more compliable treatment method , Oramed Pharmaceuticals tested the capacity of its oral insulin capsule ( ORMD-0801 , 8 mg insulin ) in addressing this resistant clinical state . Eight Type I diabetes patients with uncontrolled diabetes ( HbA1c : 7.5–10 % ) were monitored throughout the 15-day study period by means of a blind continuous glucose monitoring device . Baseline patient blood glucose behavior was monitored and recorded over a five-day pretreatment screening period . During the ensuing ten-day treatment phase , patients were asked to conduct themselves as usual and to self-administer an oral insulin capsule three times daily , just prior to meal intake . CGM data sufficient for pharmacodynamics analyses were obtained from 6 of the 8 subjects . Treatment with ORMD-0801 was associated with a significant 24.4 % reduction in the frequencies of glucose readings > 200 mg/dL ( 60.1±7.9 % pretreatment vs. 45.4±4.9 % during ORMD-0801 treatment ; p = 0.023 ) and a significant mean 16.6 % decrease in glucose area under the curve ( AUC ) ( 66055±5547 mg/dL/24 hours vs. 55060±3068 mg/dL/24 hours , p = 0.023 ) , with a greater decrease during the early evening hours . In conclusion , ORMD-0801 oral insulin capsules in conjunction with subcutaneous insulin injections , well tolerated and effectively reduced glycemia throughout the day . Trial Registration Clinical trials.gov NCT00867594 An effective , orally administered insulin product would be of substantial benefit in the treatment of patients with diabetes mellitus . This phase I/II clinical trial was the first to investigate the safety and effectiveness of a single oral dose of a modified human insulin in controlling postpr and ial plasma glucose levels in patients with type 1 diabetes mellitus who were receiving basal continuous subcutaneous insulin infusion ( CSII ) therapy . Fourteen patients with type 1 diabetes mellitus were evaluated in an open-label , 2-center , dose-escalation , nonr and omized study of oral hexyl-insulin monoconjugate 2 ( HIM2 ) . After an overnight fast and prior to receiving a st and ardized meal ( 50 % carbohydrates , 30 % fat , 20 % proteins ; 650 calories ) , the patients received either no additional insulin ( day 1 ) , or 0.5 to 1.0 mg/kg of HIM2 ( day 2 ) . All patients received a basal insulin regimen by CSII throughout the study . Blood sample s were collected for determination of glucose and insulin levels for 240 minutes post-dose . The postpr and ial glucose excursion versus time curves showed clear reductions in glucose values after both HIM2 doses ( day 2 ) relative to no treatment ( day 1 ) , although the differences in the reductions were not statistically significant . When the data for both HIM2 doses were pooled , a statistically significant effect of HIM2 on glucose excursion ( as measured by AUCex(30 - 240 ) ) was observed . Mean + /- SD values for AUCex(30 - 240 ) were 501.35 + /- 124.1 mg . h/dL after no treatment and 375.81 + /- 215.5 mg . h/dL after HIM2 ( Wilcoxon signed-rank test , P = .042 ) . The results of this study suggest that oral HIM2 , when added to a basal insulin regimen , was safe and may prove effective in controlling postpr and ial hyperglycemia in patients with type 1 diabetes mellitus . Further clinical investigation is necessary AIM The objective of the study was to establish the dose response of IN-105 tablets and explore a possible therapeutic window in type 2 diabetes subjects poorly controlled on metformin . METHODS The primary objective was to examine the effect of sequential single ascending doses of IN-105 on the plasma glucose concentration under fed conditions . All subjects received , sequentially , matching placebo , 10 , 15 , 20 and 30 mg IN-105 tablets in five consecutive periods . Tablets were administered 20 min prior to meal in all the periods . Plasma levels of immun
Output:
| Meta-analyses showed that there is no significant difference between oral and SC insulin in controlling HbA1c , FBG , 1 and 2 h postpr and ial blood glucose and producing Cmax of insulin ( P > 0.05 ) ; however oral insulin had faster action as indicated by the shorter Tmax , compared to SC insulin ( P < 0.05 ) .
Conclusion This systematic review and meta- analysis showed that oral insulin is comparable to SC insulin with regard to glycemic efficacy and safety . |
MS212250 | ***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: Results from case-control studies and prospect i ve studies suggest that diet is involved in the causation of large bowel cancer either as initiator , promoter or inhibitor of carcinogenesis . Available data are not sufficient to serve as a basis for firm specific dietary advice . In the present situation it is attractive to investigate available hypotheses within the frame work of intervention trials . The adenoma appears to be one of the most appropriate end point of intervention studies . Several arguments indicate that the adenoma-carcinoma sequence is a multistep process . Colorectal cancer could possibly be prevented by intervening in the development of a small adenoma or in the growth into a large adenoma . Four intervention trials have been published so far . One of them suggest a protective effect of antioxidants vitamins on adenoma recurrence and three of them conclude to the absence of effect of these vitamins . A protective effect of lactulose on adenoma recurrence has also been suggested . Three studies are currently evaluating the effect of calcium supplementation on adenoma recurrence or growth of calcium supplementation , three studies the effect of fibre supplements , two studies the effect of antioxidants ( one of them with calcium ) and two studies the effect of diet intervention . The results of these studies will be available within three years BACKGROUND The Polyp Prevention Trial ( PPT ) was a multicenter r and omized clinical trial design ed to determine the effects of a high-fiber ( 4.30 g/MJ ) , high-fruit- and -vegetable ( 0.84 servings/MJ ) , low-fat ( 20 % of energy from fat ) diet on the recurrence of adenomatous polyps in the large bowel . OBJECTIVE Our goal was to determine whether the PPT intervention plan could effect change in 3 dietary goals and to examine the intervention 's effect on the intake of other food groups and nutrients . DESIGN Participants with large-bowel adenomatous polyps diagnosed in the past 6 mo were r and omly assigned to either the intervention ( n = 1037 ) or the control ( n = 1042 ) group and remained in the trial for 4 y. Three dietary assessment instruments were used to measure dietary change : food-frequency question naires ( in 100 % of the sample ) , 4-d food records ( in a 20 % r and om cohort ) , and 24-h dietary recalls ( in a 10 % r and om sample ) . RESULTS Intervention participants made and sustained significant changes in all PPT goals as measured by the dietary assessment instruments ; the control participants ' intakes remained essentially the same throughout the trial . The absolute differences between the intervention and control groups over the 4-y period were 9.7 % of energy from fat ( 95 % CI : 9.0 % , 10.3 % ) , 1.65 g dietary fiber/MJ ( 95 % CI : 1.53 , 1.74 ) , and 0.27 servings of fruit and vegetables/MJ ( 95 % CI : 0.25 , 0.29 ) . Intervention participants also reported significant changes in the intake of other nutrients and food groups . The intervention group also had significantly higher serum carotenoid concentrations and lower body weights than did the control group . CONCLUSION Motivated , free-living individuals , given appropriate support , can make and sustain major dietary changes over a 4-y period Adherence determinants and key adherence research issues are discussed for three types of r and omized controlled trials : pharmacological , dietary , and physical activity . This article highlights theoretical and method ological limitations that have hampered the ability to identify patients at risk for poor treatment compliance . Control Clin Trials Objective To evaluate the impact of a diet and physical activity intervention ( BeWEL ) on weight change in people with a body mass index > 25 weight (kg)/height (m)2 at increased risk of colorectal cancer and other obesity related comorbidities . Design Multicentre , parallel group , r and omised controlled trial . Setting Four Scottish National Health Service health boards . Participants 329 overweight or obese adults ( aged 50 to 74 years ) who had undergone colonoscopy after a positive faecal occult blood test result , as part of the national bowel screening programme , and had a diagnosis of adenoma confirmed by histopathology . 163 were r and omised to intervention and 166 to control . Intervention Participants were r and omised to a control group ( weight loss booklet only ) or 12 month intervention group ( three face to face visits with a lifestyle counsellor plus monthly 15 minute telephone calls ) . A goal of 7 % reduction in body weight was set and participants received a personalised energy prescription ( 2508 kJ ( 600 kcal ) below that required for weight maintenance ) and bodyweight scales . Motivational interviewing techniques explored self assessed confidence , ambivalence , and personal values concerning weight . Behavioural strategies included goal setting , identifying intentions of implementation , self monitoring of body weight , and counsellor feedback about reported diet , physical activity , and weight change . Main outcome measures The primary outcome was weight change over 12 months . Secondary outcomes included changes in waist circumference , blood pressure , fasting cardiovascular biomarkers , and glucose metabolism variables , physical activity , diet , and alcohol consumption . Results At 12 months , data on the primary outcome were available for 148 ( 91 % ) participants in the intervention group and 157 ( 95 % ) in the control group . Mean weight loss was 3.50 kg ( SD 4.91 ) ( 95 % confidence interval 2.70 to 4.30 ) in the intervention group compared with 0.78 kg ( SD 3.77 ) ( 0.19 to 1.38 ) in the control group . The group difference was 2.69 kg ( 95 % confidence interval 1.70 to 3.67 ) . Differences between groups were significant for waist circumference , body mass index , blood pressure , blood glucose level , diet , and physical activity . No reported adverse events were considered to be related to trial participation . Conclusions Significant weight loss can be achieved by a diet and physical activity intervention initiated within a national colorectal cancer screening programme , offering considerable potential for risk reduction of disease in older adults . Trial registration Current Controlled Trials IS RCT N53033856 Westernization or industrialization leads to an increase in rates of colon cancer , which is the second leading cause of malignant death in the United States [ 1 ] . Although the precise causes of colon cancer remain unclear , a diet high in red meat or animal fat and low in fruits and vegetables appears to increase the risk for this malignancy [ 2 , 3 ] . It is perhaps less well recognized that an inverse association between physical activity and risk for colon cancer has been seen in studies of occupational activity only [ 4 - 12 ] and of both job-related and recreational activity [ 13 - 23 ] . In addition , many studies have found an association between body mass and elevated risk for colon cancer in men ; this association is weaker in women [ 24 - 33 ] . The fact that the association is stronger in men suggests that the abdominal distribution of adiposity typical in men may be an important component of enhanced risk . More limited evidence suggests that height , which may be a proxy for a person 's net energy intake during childhood and adolescence , is related to a higher risk for colon cancer [ 33 - 35 ] . We examine the association between physical activity , obesity , and attained height in relation to risk for colon cancers and their precursory adenomas in a large cohort of male health professionals in the United States . Waist and hip circumferences were available for a subcohort of the study population . We address the hypotheses that physical inactivity , obesity , and height increase the risk for colon cancer and adenoma independently of each other and of diet , and that the abdominal pattern of obesity is an additional independent risk factor . Methods Study Population The Health Professionals Follow-up Study [ 36 ] was started in 1986 ; in that year , 51 529 male dentists , optometrists , osteopaths , podiatrists , pharmacists , and veterinarians in the United States between 40 and 75 years of age responded to a mailed question naire . They reported on their leisure-time physical activity ( described below ) ; current body weight ; weight at age 21 years ; height ; history of cancer and other medical conditions ; parental history of various diseases , including colorectal cancer ; and use of aspirin and other nonsteroidal anti-inflammatory medications . They also reported dietary and alcohol intake using a vali date d [ 37 , 38 ] , semi-quantitative food-frequency question naire . We mailed an optional question naire in 1987 to assess waist and hip circumferences . In 1988 , 1990 , and 1992 , we up date d exposure information and ascertained newly diagnosed medical conditions and history of colonoscopy or sigmoidoscopy , including the indications for endoscopy : bleeding in stool , positive results from tests for occult fecal blood , abdominal pain , diarrhea or constipation , family history of colorectal cancer , routine screening without symptoms , or follow-up [ 39 ] . Most of the deaths in the cohort were reported by family members or by the postal system in response to the follow-up question naires . We also used the National Death Index to identify deaths among nonrespondents [ 40 ] . Assessment of Physical Activity The 1986 question naire included a section about mainly recreational or leisure-time physical activity . The reliability and validity of question naires design ed to assess physical activity have been investigated [ 41 - 43 ] . A question naire such as the one used in our cohort was evaluated in a cohort of U.S. nurses and was found to provide useful information [ 44 ] , and similar results were found during a similar validation study done within the Health Professionals cohort ( Chasan-Taber S. Personal communication ) . Participants reported the average time per week spent doing each of eight moderate and vigorous activities , choosing from among 10 possible responses that ranged from 0 minutes to 11 or more hours per week . The specific activities listed were walking or hiking outdoors ( including walking during golf ) ; jogging ( slower than 10 minutes/mile ) ; running ( 10 minutes/mile or faster ) ; bicycling ( including that done on a stationary machine ) ; lap swimming ; tennis , squash , or racquetball ; and calisthenics or rowing . In addition , each respondent reported the number of flights of stairs he climbed daily and his usual walking pace . The reported time spent at each activity per week was multiplied by its typical energy expenditure requirements expressed in metabolic equivalents ( METs ) [ 45 ] to yield a MET-hour score . One MET , which is the energy expended by sitting quietly , is equivalent to 3.5 mL of oxygen uptake per kilogram of body weight per minute for a 70-kg adult . For example , 1 hour per week of running contributed 10.2 MET-hours , 1 hour of tennis contributed 6 MET-hours , and 1 hour of walking at a moderate pace contributed 3.2 MET-hours . Body weight was excluded from the derivation of energy expenditure from physical activity to avoid confounding the expenditure variable by body weight . If more than one published intensity level was available for a given activity , the moderate or general MET value was chosen . An average MET value was assigned to the categories that listed more than one activity , such as rowing or calisthenics , and squash or racquetball . Assessment of Anthropometric Variables Each man reported his current weight and height and his weight at age 21 years on the 1986 question naire . In 1987 , we mailed an optional question naire once to obtain additional exposure information , including body circumference measurements . We instructed each participant to measure ( to the nearest quarter inch ) his waist at the umbilicus and his hips at the largest circumference between the waist and thighs while st and ing and without measuring over bulky clothing [ 46 ] . We provided a tape measure and an illustration to help st and ardize the measurements . Sixty-five percent of the cohort responded . We used the Quetelet index ( kilograms/height in meters2 ) as a measure of total adiposity , waist-to-hip ratio to measure relative distribution of fat , and waist circumference to estimate total abdominal fat . Although the waist-to-hip ratio has been used more widely , waist circumference provides an estimate of absolute abdominal adiposity , the component most closely related to important metabolic abnormalities , including hyperinsulinemia , hypertension , and high triglyceride levels . To remove extraneous variation in the waist circumference because of height ( taller men tend to have larger waist circumferences due to their larger body size rather than to obesity ) , we adjusted waist for height using residual analysis [ 47 ] . We first regressed waist on height using multiple linear regression and then added the residual to the average waist size ( 37.4 inches ) for a man of average height ( 70 inches ) to convert this measure back to the initial scale . This conversion created for each man a st and ardized waist circumference unconfounded by height . We evaluated the precision of self-reported anthropometric measures among 123 cohort members who were part of a dietary validation study [ 46 ] . Trained technicians paid the sub study participants two visits , approximately 6 months apart , to measure current weight and waist and hip circumferences . The Pearson correlation between self-report and the average of the technicians ' two measurements was 0.97 for weight , 0.95 for waist circumference , 0.88 for hip circumference , and 0.69 for waist-to-hip ratio . The men 's self- measurements of their waist circumferences were 0.36 inches greater , their self- measurements of hip circumferences were 0.78 inches smaller , and their self-
Output:
| Conclusions The findings of this review indicate that behavioural interventions can encourage colorectal adenoma patients to improve their diet .
This review was not however able to clearly characterise effective interventions promoting increased physical activity in this patient group . |
MS212251 | ***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: Aims : Assess the efficacy and safety of saxagliptin added to a submaximal sulphonylurea dose vs. uptitration of sulphonylurea monotherapy in patients with type 2 diabetes and inadequate glycaemic control with sulphonylurea monotherapy . Methods and patients : A total of 768 patients ( 18–77 years ; HbA1c screening ≥ 7.5 to ≤ 10.0 % ) were r and omised and treated with saxagliptin 2.5 or 5 mg in combination with glyburide 7.5 mg vs. glyburide 10 mg for 24 weeks . Blinded uptitration glyburide was allowed in the glyburide-only arm to a maximum total daily dose of 15 mg . Efficacy analyses were performed using ANCOVA and last-observation-carried-forward methodology . Results : At week 24 , 92 % of glyburide-only patients were uptitrated to a total glyburide dose of 15 mg/day . Saxagliptin 2.5 and 5 mg provided statistically significant adjusted mean decreases from baseline to week 24 vs. uptitrated glyburide , respectively , in HbA1c ( −0.54 % , −0.64 % vs. + 0.08 % ; both p < 0.0001 ) and fasting plasma glucose ( −7 , −10 vs. + 1 mg/dl ; p = 0.0218 and p = 0.002 ) . The proportion of patients achieving an HbA1c < 7 % was greater for saxagliptin 2.5 and 5 mg vs. uptitrated glyburide ( 22.4 % and 22.8 % vs. 9.1 % ; both p < 0.0001 ) . Postpr and ial glucose area under the curve was reduced for saxagliptin 2.5 and 5 mg vs. uptitrated glyburide ( −4296 and −5000 vs. + 1196 mg·min/dl ; both p < 0.0001 ) . Adverse event occurrence was similar across all groups . Reported hypoglycaemic events were not statistically significantly different for saxagliptin 2.5 ( 13.3 % ) and 5 mg ( 14.6 % ) vs. uptitrated glyburide ( 10.1 % ) . Conclusion : Saxagliptin added to submaximal glyburide therapy led to statistically significant improvements vs. uptitration of glyburide alone across key glycaemic parameters and was generally well tolerated Background DA-1229 is a novel , potent and selective dipeptidyl peptidase-4 ( DPP-IV ) inhibitor that is orally bioavailable . We aim ed to evaluate the optimal dose , efficacy and safety of DA-1229 , in Korean subjects with type 2 diabetes mellitus suboptimally controlled with diet and exercise . Methods We enrolled 158 patients ( mean age , 53 years and a mean BMI , 25.6 kg/m2 ) . The mean baseline fasting plasma glucose level , HbA1c and duration of diabetes were 8.28 mmol/L , 7.6 % ( 60 mmol/mol ) and 3.9 years , respectively . After 2 or 6 weeks of an exercise and diet program followed by 2 weeks of a placebo period , the subjects were r and omized into one of four groups for a 12-week active treatment period : placebo , 2.5 , 5 or 10 mg of DA-1229 . Results All three doses of DA-1229 significantly reduced HbA1c from baseline compared to the placebo group ( −0.09 in the placebo group vs. −0.56 , −0.66 and −0.61 % in 2.5 , 5 and 10-mg groups , respectively ) but without any significant differences between the doses . Insulin secretory function , as assessed by homeostasis model assessment β-cell , the insulinogenic index , 2-h oral glucose tolerance test ( OGTT ) C-peptide and post-OGTT C-peptide area under the curve (AUC)0–2h , significantly improved with DA-1229 treatment . The incidence of adverse events was similar between the treatment groups and DA-1229 did not affect body weight or induce hypoglycaemic events . Conclusions DA-1229 monotherapy ( 5 mg for 12 weeks ) improved HbA1c , fasting plasma glucose level , OGTT results and β-cell function . This drug was well tolerated in Korean subjects with type 2 diabetes mellitus . © 2014 The Authors . Diabetes/Metabolism Research and Review s published by John Wiley & Sons , Ltd. DA-1229 is a novel , potent and selective DPP-IV inhibitor that is orally bioavailable . In a pharmacodynamic study , more than 80 % of DPP-IV was inhibited by a single dose of 5 mg or higher of DA-1229 , and this level of inhibition was maintained for at least 24 h after a single dose of 10 mg or higher of DA-1229 . This phase II clinical trial was design ed to evaluate the efficacy and safety of oral DA-1229 and to determine the optimal dose to use for a phase III clinical study in Korean subjects with type 2 diabetes UNLABELLED Inhibition of dipeptidyl peptidase-4 enhances the activity of incretin hormones , improving glycemic control in subjects with type 2 diabetes . This twelve-week r and omized , double-masked , placebo-controlled study assessed the efficacy and tolerability of the specific and potent oral dipeptidyl peptidase-4 inhibitor , vildagliptin ( 25 mg , bid , n=70 ) VS . placebo ( bid , n=28 ) in previously diet-treated subjects with type 2 diabetes . St and ardized meal tests were performed at baseline and endpoint . The between-group difference in adjusted mean change in HbA1c from baseline to endpoint was - 0.6 + /- 0.2 % ( p=0.0012 ) for the whole cohort ( baseline 8.0 % ) and -1.2 % for subjects with baseline HbA1c 8.0 - 9.5 % . Fasting glucose and mean pr and ial glucose were reduced by 1.1 + /- 0.4 ( p=0.0043 ) and 1.9 + /- 0.5 mmol/l ( p < 0.0001 ) , respectively . The between-group differences in corrected insulin response at peak glucose and mean pr and ial C-peptide were + 0.06 + /- 0.02 ( p=0.0258 ) and + 0.10 + /- 0.03 nmol/l ( p=0.0031 ) , respectively . Vildagliptin had no effect on fasting lipid levels or body weight . The incidence of adverse events was similar in subjects receiving placebo ( 71.4 % ) and vildagliptin ( 55.7 % ) . CONCLUSION monotherapy with vildagliptin is well tolerated and improves glycemic control in diet-treated subjects with type 2 diabetes . Concomitant improvements in beta-cell function were also observed . Subjects with higher baseline HbA1c levels showed greater response AIM To assess the safety and efficacy of the potent and selective dipeptidyl peptidase-4 inhibitor linagliptin 5 mg when given for 24 weeks to patients with type 2 diabetes who were either treatment-naive or who had received one oral antidiabetes drug ( OAD ) . METHODS This multicentre , r and omized , parallel group , phase III study compared linagliptin treatment ( 5 mg once daily , n = 336 ) with placebo ( n = 167 ) for 24 weeks in type 2 diabetes patients . Before r and omization , patients pretreated with one OAD underwent a washout period of 6 weeks , which included a placebo run-in period during the last 2 weeks . Patients previously untreated with an OAD underwent a 2-week placebo run-in period . The primary endpoint was the change in HbA1c from baseline after 24 weeks of treatment . RESULTS Linagliptin treatment result ed in a placebo-corrected change in HbA1c from baseline of -0.69 % ( p < 0.0001 ) at 24 weeks . In patients with baseline HbA1c ≥ 9.0 % , the adjusted reduction in HbA1c was 1.01 % ( p < 0.0001 ) . Patients treated with linagliptin were more likely to achieve a reduction in HbA1c of ≥0.5 % at 24 weeks than those in the placebo arm ( 47.1 and 19.0 % , respectively ; odds ratio , OR = 4.2 , p < 0.0001 ) . Fasting plasma glucose improved by -1.3 mmol/l ( p < 0.0001 ) with linagliptin vs. placebo , and linagliptin produced an adjusted mean reduction from baseline after 24 weeks in 2-h postpr and ial glucose of -3.2 mmol/l ( p < 0.0001 ) . Statistically significant and relevant treatment differences were observed for proinsulin/insulin ratio ( p = 0.025 ) , Homeostasis Model Assessment -%B ( p = 0.049 ) and disposition index ( p = 0.0005 ) . There was no excess of hypoglycaemic episodes with linagliptin vs. placebo and no patient required third-party intervention . Mild or moderate renal impairment did not influence the trough plasma levels of linagliptin . CONCLUSIONS Monotherapy with linagliptin produced a significant , clinical ly meaningful and sustained improvement in glycaemic control , accompanied by enhanced parameters of β-cell function . The safety profile of linagliptin was comparable with that of placebo AIMS This study was conducted to compare the glycaemic efficacy and safety of initial combination therapy with the fixed-dose combination of sitagliptin and metformin versus metformin monotherapy in drug-naive patients with type 2 diabetes . METHODS This double-blind study ( 18-week Phase A and 26-week Phase B ) r and omized 1250 drug-naÏve patients with type 2 diabetes [ mean baseline haemoglobin A1c ( HbA1c ) 9.9 % ] to sitagliptin/metformin 50/500 mg bid or metformin 500 mg bid ( uptitrated over 4 weeks to achieve maximum doses of sitagliptin/metformin 50/1000 mg bid or metformin 1000 bid ) . Results of the primary efficacy endpoint ( mean HbA1c reductions from baseline at the end of Phase A ) are reported herein . RESULTS At week 18 , mean change from baseline HbA1c was -2.4 % for sitagliptin/metformin FDC and -1.8 % for metformin monotherapy ( p < 0.001 ) ; more patients treated with sitagliptin/metformin FDC had an HbA1c value < 7 % ( p < 0.001 ) versus metformin monotherapy . Changes in fasting plasma glucose were significantly greater with sitagliptin/metformin FDC ( -3.8 mmol/l ) versus metformin monotherapy ( -3.0 mmol/l ; p < 0.001 ) . Homeostasis model assessment of β-cell function ( HOMA-β ) and fasting proinsulin/insulin ratio were significantly improved with sitagliptin/metformin FDC versus metformin monotherapy . Baseline body weight was reduced by 1.6 kg in each group . Both treatments were generally well tolerated with a low and similar incidence of hypoglycaemia . Abdominal pain ( 1.1 and 3.9 % ; p = 0.002 ) and diarrhoea ( 12.0 and 16.6 % ; p = 0.021 ) occurred significantly less with sitagliptin/metformin FDC versus metformin monotherapy ; the incidence of nausea and vomiting was similar in both groups . CONCLUSION Compared with metformin monotherapy , initial treatment with sitagliptin/metformin FDC provided superior glycaemic improvement with a similar degree of weight loss and lower incidences of abdominal pain and diarrhoea BACKGROUND Type 2 diabetes mellitus ( T2DM ) is a significant burden in China , where approximately 114 million patients have been diagnosed with diabetes . Chinese patients present with prominent β-cell failure , with result ing deficiency in insulin secretion , particularly early phase insulin secretion leading to postpr and ial hyperglycemia . Sitagliptin , a selective once-daily oral dipeptidyl peptidase-4 inhibitor , has been shown to improve glycemic control as monotherapy and in combination with other antihyperglycemic agents , including sulfonylureas and metformin . METHODS This was a multicenter r and omized double-blind placebo-controlled study conducted in China . The study assessed the safety and efficacy of the addition of sitagliptin 100 mg once daily versus placebo on changes from
Output:
| However , we found no significant improvement in HOMA-IR following treatment with DPP-4 inhibitors as mono-therapy or as add-on therapy .
In conclusion , DPP-4 inhibitors as monotherapy or as add-on therapy significantly improved beta-cell function but had no significant effect on insulin resistance in type 2 diabetes |
MS212252 | ***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 aim of this study was to compare changes in periodontal status in a Swedish population over a period of 20 years . Cross-sectional studies were carried out in Jönköping County in 1973 , 1983 , and 1993 . Individuals were r and omly selected from the following age groups : 20 , 30 , 40 , 50 , 60 , and 70 years . A total of 600 individuals were examined in 1973 , 597 in 1983 , and 584 in 1993 . The number of dentate individuals was 537 in 1973 , 550 in 1983 , and 552 in 1993 . Based on clinical data and full mouth intra-oral radiographs , all individuals were classified into 5 groups according to the severity of the periodontal disease experience . Individuals were classified as having a healthy periodontium ( group 1 ) , gingivitis without signs of alveolar bone loss ( group 2 ) , moderate alveolar bone loss not exceeding 1/3 of the normal alveolar bone height ( group 3 ) , severe alveolar bone loss ranging between 1/3 and 2/3 of the normal alveolar bone height ( group 4 ) , or alveolar bone loss exceeding 2/3 of the normal bone height and angular bony defects and /or furcation defects ( group 5 ) . During these 20 years , the number of individuals in groups 1 and 2 increased from 49 % in 1973 to 60 % in 1993 . In addition , there was a decrease in the number of individuals in group 3 , the group with moderate periodontal bone loss . Groups 4 and 5 comprised 13 % of the population and showed no change in general between 1983 and 1993 . The individuals comprising these groups in 1993 , however , had more teeth than those who comprised these groups in 1983 ; on the average , the individuals in disease group 4 had 4 more teeth and those in disease group 5 , 2 more teeth per subject . In 1973 , these 2 groups were considerably smaller , probably because of wider indications for tooth extraction s and fewer possibilities for periodontal care which meant that many of these individuals had become edentulous and were not placed in a group . Individuals in groups 3 , 4 , and 5 were subdivided according to the number of surfaces ( % ) with gingivitis and periodontal pockets ( > or = 4 mm ) . In 1993 , 20 % , 42 % . and 67 % of the individuals in groups 3 , 4 , and 5 respectively were classified as diseased and in need of periodontal therapy with > 20 % bleeding sites and > 10 % sites with periodontal pockets > or = 4 mm . In conclusion , an increase in the number of individuals with no marginal bone loss and a decrease in the number of individuals with moderate alveolar bone loss can be seen . The prevalence of individuals in the severe periodontal disease groups ( 4 , 5 ) was unchanged during the last 10 years ; however , the number of teeth per subject increased BACKGROUND One hypothesis to explain the association between periodontal disease ( PD ) preterm/low birth weight ( PT/LBW ) is that PT/LBW may be indirectly mediated through translocation of bacteria or bacterial products in the systemic circulation . Transient bacteremias occur in subjects with marginal periodontitis or with gingivitis , and it is possible that bacteria and their products may reach the placental membranes hematogenously and provide the inflammatory effect to induce preterm labor . The effect of gingivitis as a potential risk factor for PT/LBW has still not been studied . A r and omized controlled trial was undertaken to determine the effect of routine plaque control and scaling on the pregnancy outcomes in women with gingivitis . METHODS Eight hundred seventy ( 870 ) pregnant women with gingivitis , aged 18 to 42 , were enrolled while receiving prenatal care in Santiago , Chile . Women were r and omly assigned in a two-to-one fashion to either a treatment group ( N = 580 ) , receiving periodontal treatment before 28 weeks of gestation or to a control group ( N = 290 ) , receiving periodontal treatment after delivery . Periodontal therapy consisted of plaque control , scaling , and daily rinsing with 0.12 % clorhexidine . Maintenance therapy was provided every 2 to 3 weeks until delivery , and consisted of oral hygiene instruction and supragingival plaque removal by instrumentation , as needed . The primary outcomes assessed were delivery at less than 37 weeks of gestation or an infant weighing less than 2,500 g. RESULTS Of the 870 women enrolled , 36 women ( 27 in the treatment group and nine in the control group ) were excluded from the analyses for different reasons . The incidence of PT/LBW in the treatment group was 2.14 % ( 12/560 ) and in the control group , 6.71 % ( 19/283 ) ( odds ratio [ OR ] 3.26 ; 95 % confidence interval [ CI ] 1.56 to 6.83 ; P = 0.0009 ) . Multivariate logistic regression analysis showed that , after adjusting for several known risk factors for PT/LBW , women with gingivitis were at a higher risk of PT/LBW than women who received periodontal treatment ( OR 2.76 ; 95%CI 1.29 to 5.88 ; P = 0.008 ) . CONCLUSIONS Periodontal treatment significantly reduced the PT/LBW rate in this population of women with pregnancy-associated gingivitis . Within the limitions of this study , we conclude that gingivitis appears to be an independent risk factor for PT/LBW for this population Periodontitis has been associated with adverse pregnancy outcomes . Results from intervention studies are few and controversial . The present study assessed the effects of non-surgical periodontal treatment in the occurrence of adverse pregnancy outcomes . Two hundred forty-six eligible women were r and omly divided into two groups : periodontitis intervention ( n = 122 ; undergoing non-surgical treatment during gestation ) and periodontitis control ( n = 124 ; not treated during gestation ) . Univariate analysis was performed and estimates of relative risk were reported . Data from 225 women were analyzed . No differences for preterm birth ( p = 0.721 ) , low birth weight ( p = 0.198 ) , and preterm low birth weight ( p = 0.732 ) rates were observed . Relative risk estimates for preterm birth , low birth weight , and preterm low birth weight in the periodontitis intervention group were 0.915 ( 95 % CI 0.561–1.493 ) , 0.735 ( 95 % CI 0.459–1.179 ) , and 0.927 ( 0.601–1.431 ) , respectively . Non-surgical periodontal treatment during the second semester of gestation did not reduce the risk for preterm birth , low birth weight , and preterm low birth weight Considering the high prevalence of preterm birth ( PTB ) and low birth weight ( LBW ) and their complications as well as the role played by periodontal disease in their incidence and the lack of any report of periodontal therapy on these problems in Iran , the goal of the present research was to determine the effects of periodontal treatment on PLBW incidence among women with moderate or advanced periodontitis who were referred to Javaheri hospital ( 2004 - 2005 ) . This clinical trial research was conducted on 30 pregnant women age ranging from 18 - 35 years old , with moderate or advanced periodontitis . Fifteen subjects r and omly underwent the first phase of periodontal treatment including scaling , root planning and the use of 0.2 % chlorhexidine mouth rinse for one week . None of these steps were taken for the controls . After necessary follow ups , the effect of periodontal treatment on birth term and birth weight were analyzed statistically . This research was conducted on 30 subjects , 15 controls and 15 cases in study group . In the control group , the observed rate of PLBW was 26.7 % whereas among periodontally treated group , phase I , PLBW infant was not observed ( P < 0.05 ) . Infants birth weight were ( 3059.3 - 389.7 ) gms in study group and ( 3371 - 394.2 ) gms in the control group and respectively ( P < 0.05 ) . Periodontal therapy , phase I , results in a reduction in PLBW incidence rate . Therefore , the application of such a simple method among periodontally diseased pregnant women is recommended BACKGROUND Few studies have examined the potential effects of periodontal treatment during pregnancy on pregnancy outcomes , periodontal status , and inflammatory biomarkers . METHODS A r and omized , delayed-treatment , controlled pilot trial was conducted to evaluate the effects of second-trimester scaling and root planing and the use of a sonic toothbrush on the rate of preterm delivery ( < 37 weeks gestation ) . Secondary outcome measures included changes in periodontal status , levels of eight oral pathogens , levels of gingival crevicular fluid ( GCF ) interleukin-1beta ( IL-1beta ) , prostagl and in E(2 ) ( PGE(2 ) ) , 8-isoprostane ( 8-iso ) , and IL-6 , and serum levels of IL-6 , soluble intercellular adhesion molecule 1 ( sICAM1 ) , 8-isoprostane , soluble glycoprotein 130 ( sGP130 ) , IL-6 soluble receptor ( IL-6sr ) , and C-reactive protein ( CRP ) . Logistic regression models were used to test for effects of treatment on preterm delivery . Secondary outcomes were analyzed by analysis of covariance adjusting for subject baseline values . RESULTS Periodontal intervention result ed in a significantly decreased incidence odds ratio ( OR ) for preterm delivery ( OR = 0.26 ; 95 % confidence interval = 0.08 to 0.85 ) , adjusting for baseline periodontal status which was unbalanced after r and omization . Pregnancy without periodontal treatment was associated with significant increases in probing depths , plaque scores , GCF IL-1beta , and GCF IL-6 levels . Intervention result ed in significant improvements in clinical status ( attachment level , probing depth , plaque , gingivitis , and bleeding on probing scores ) and significant decreases in levels of Prevotella nigrescens and Prevotella intermedia , serum IL-6sr , and GCF IL-1beta . CONCLUSIONS Results from this pilot study ( 67 subjects ) provide further evidence supporting the potential benefits of periodontal treatment on pregnancy outcomes . Treatment was safe , improved periodontal health , and prevented periodontal disease progression . Preliminary data show a 3.8-fold reduction in the rate of preterm delivery , a decrease in periodontal pathogen load , and a decrease in both GCF IL-1beta and serum markers of IL-6 response . However , further studies will be needed to substantiate these early findings BACKGROUND A recent clinical trial ( Obstetrics and Periodontal Therapy [ OPT ] Study ) demonstrated that periodontal therapy during pregnancy improved periodontal outcomes but failed to impact preterm birth . The present study evaluated seven target bacteria , Aggregatibacter actinomycetemcomitans ( previously Actinobacillus actinomycetemcomitans ) , Porphyromonas gingivalis , Treponema denticola , Tannerella forsythia ( previously T. forsythensis ) , Prevotella intermedia , Campylobacter rectus , and Fusobacterium nucleatum , in subgingival dental plaque of pregnant women in the OPT Study and their association with birth outcomes . METHODS Pregnant women were r and omly assigned to receive periodontal treatment before 21 weeks ' gestation or after delivery . Subgingival plaque was sample d at baseline ( 13 to 16 weeks ; 6 days of gestation ) and at 29 to 32 weeks . We analyzed subgingival plaque sample s from women who experienced fetal loss , delivered a live preterm infant ( preterm women ) , or delivered a full-term infant ( full-term women ) . Sample s were analyzed using quantitative polymerase chain reaction . Associations between preterm birth and bacterial counts and percentages were tested using multiple linear regression . RESULTS No significant differences were observed at baseline between preterm and full-term women for any measured bacterial species or group of species , after accounting for multiple comparisons . Changes in bacterial counts and proportions during pregnancy also were not associated with birth outcomes . In full-term and preterm women , periodontal therapy significantly reduced ( P < 0.01 ) counts of all target species except for A. actinomycetemcomitans . CONCLUSIONS In pregnant women with periodontitis , non-surgical periodontal therapy significantly reduced levels of periodontal pathogens . Baseline levels of selected periodontal pathogens or changes in these bacteria result ing from therapy were not associated with preterm birth BACKGROUND Preterm low birth weight was reported to be related to periodontal infections that might influence the fetus-placenta complex . The aim of this study was to provide periodontal treatment for pregnant women and to evaluate if this treatment can interfere with pregnancy duration and weight of the newborn . METHODS The sample consisted of 450 pregnant women who were under prenatal care at a polyclinic in Três Corações , Brazil . Women with risk factors , such as systemic alterations ( ischemic cardiopathy , hypertension , tuberculosis , di
Output:
| Meta- analysis using this methodology concluded that there is no benefit for periodontal treatment to reduce complications of pregnancy . |
MS212253 | ***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 Near-infrared spectroscopy ( NIRS ) noninvasively measures peripheral tissue oxygen saturation ( StO2 ) . NIRS may be utilized along with a vascular occlusion test , in which limb blood flow is temporarily occluded and released , to quantify a tissue bed 's rate of oxygen exchange during ischemia and recovery . The objective of this study was to test the hypothesis that NIRS-derived StO2 measures ( StO2 initial , StO2 occlusion and StO2 recovery ) identify patients who are in shock and at increased risk of organ dysfunction ( Sequential Organ Failure Assessment ( SOFA ) score ≥ 2 at 24 hours ) and dying in the hospital . Methods This prospect i ve , observational study comprised a convenience sample of three cohorts of adult patients ( age > 17 years ) at three urban university emergency departments : ( 1 ) a septic shock cohort ( systolic blood pressure < 90 after fluid challenge ; the " SHOCK " cohort , n = 58 ) , ( 2 ) a sepsis without shock cohort ( the " SEPSIS " cohort , n = 60 ) and emergency department patients without infection ( n = 50 ) . We measured the StO2 initial , StO2 occlusion and StO2 recovery slopes for all patients . Outcomes were sepsis syndrome severity , organ dysfunction ( SOFA score at 24 hours ) and in-hospital mortality . Results Among the 168 patients enrolled , mean initial StO2 was lower in the SHOCK cohort than in the SEPSIS cohort ( 76 % vs 81 % ) , with an impaired occlusion slope ( -10.2 and 5.2%/minute vs -13.1 and 4.4%/minute ) and an impaired recovery slope ( 2.4 and 1.6%/second vs 3.9 and 1.7%/second ) ( P < 0.001 for all ) . The recovery slope was well-correlated with SOFA score at 24 hours ( -0.35 ; P < 0.001 ) , with a promising area under the curve ( AUC ) for mortality of 0.81 . The occlusion slope correlation with SOFA score at 24 hours was 0.21 ( P < 0.02 ) , with a fair mortality AUC of 0.70 . The initial StO2 was significantly but less strongly correlated with SOFA score at 24 hours ( -0.18 ; P < 0.04 ) , with a poor mortality AUC of 0.56 . Conclusions NIRS measurements for the StO2 initial , StO2 occlusion and StO2 recovery slope were abnormal in patients with septic shock compared to sepsis patients . The recovery slope was most strongly associated with organ dysfunction and mortality . Further validation is warranted . Trial registration Introduction The aim of this study was to evaluate the effects of red blood cell ( RBC ) transfusions on muscle tissue oxygenation , oxygen metabolism and microvascular reactivity in critically ill patients using near-infrared spectroscopy ( NIRS ) technology . Methods This prospect i ve , observational study included 44 consecutive patients hospitalized in the 31-bed , medical-surgical intensive care unit of a university hospital with anemia requiring red blood cell transfusion . Thenar tissue oxygen saturation ( StO2 ) and muscle tissue hemoglobin index ( THI ) were measured using a tissue spectrometer ( InSpectra ™ Model 325 ; Hutchinson Technology Inc. , Hutchinson , MN , USA ) . A vaso-occlusive test was performed before and 1 hour after RBC transfusion by rapid inflation of a pneumatic cuff around the upper arm . The following variables were recorded : THI , the StO2 desaturation slope during the occlusion ( % /minute ) and the StO2 upslope of the reperfusion phase following the ischemic period ( % /second ) . Muscle oxygen consumption ( NIR VO2 ; arbitrary units ) was calculated as the product of the inverse StO2 desaturation slope and the mean THI over the first minute of arterial occlusion . Results Blood transfusion result ed in increases in hemoglobin ( from 7.1 ( 6.7 to 7.7 ) to 8.4 ( 7.1 to 9 ) g/dl ; P < 0.01 ) and in oxygen delivery ( from 306 ( 259 to 337 ) to 356 ( 332 to 422 ) ml/minute/m2 ; P < 0.001 ) . However , systemic VO2 was unchanged . RBC transfusion did not globally affect NIRS-derived variables , but there was considerable interindividual variation . Changes in the StO2 upslope of the reperfusion phase after transfusion were negatively correlated with baseline StO2 upslope of the reperfusion phase ( r2 = 0.42 ; P < 0.0001 ) . Changes in NIR VO2 after transfusion were also negatively correlated with baseline NIR VO2 ( r2 = 0.48 ; P = 0.0015 ) . There were no correlations between RBC storage time and changes in StO2 slope or NIR VO2 . Conclusions Muscle tissue oxygenation , oxygen consumption and microvascular reactivity are globally unaltered by RBC transfusion in critically ill patients . However , muscle oxygen consumption and microvascular reactivity can improve following transfusion in patients with alterations of these variables at baseline Introduction The prognostic value of continuous monitoring of tissue oxygen saturation ( StO2 ) during early goal -directed therapy of critically ill patients has not been investigated . We conducted this prospect i ve study to test the hypothesis that the persistence of low StO2 levels following intensive care admission is related to adverse outcome . Methods We followed 22 critically ill patients admitted with increased lactate levels ( > 3 mmol/l ) . Near-infrared spectroscopy ( NIRS ) was used to measure the thenar eminence StO2 and the rate of StO2 increase ( RincStO2 ) after a vascular occlusion test . NIRS dynamic measurements were recorded at intensive care admission and each 2-hour interval during 8 hours of resuscitation . All repeated StO2 measurements were further compared with Sequential Organ Failure Assessment ( SOFA ) , Acute Physiology and Chronic Health Evaluation ( APACHE ) II and hemodynamic physiological variables : heart rate ( HR ) , mean arterial pressure ( MAP ) , central venous oxygen saturation ( ScvO2 ) and parameters of peripheral circulation ( physical examination and peripheral flow index ( PFI ) ) . Results Twelve patients were admitted with low StO2 levels ( StO2 < 70 % ) . The mean scores for SOFA and APACHE II scores were significantly higher in patients who persisted with low StO2 levels ( n = 10 ) than in those who exhibited normal StO2 levels ( n = 12 ) at 8 hours after the resuscitation period ( P < 0.05 ; median ( interquartile range ) : SOFA , 8 ( 7 to 11 ) vs. 5 ( 3 to 8) ; APACHE II , 32(24 to 33 ) vs. 19 ( 15 to 25 ) ) . There was no significant relationship between StO2 and mean global hemodynamic variables ( HR , P = 0.26 ; MAP , P = 0.51 ; ScvO2 , P = 0.11 ) . However , there was a strong association between StO2 with clinical abnormalities of peripheral perfusion ( P = 0.004 ) , PFI ( P = 0.005 ) and RincStO2 ( P = 0.002 ) . The persistence of low StO2 values was associated with a low percentage of lactate decrease ( P < 0.05 ; median ( interquartile range ) : 33 % ( 12 to 43 % ) vs. 43 % ( 30 to 54 % ) ) . Conclusions We found that patients who consistently exhibited low StO2 levels following an initial resuscitation had significantly worse organ failure than did patients with normal StO2 values , and found that StO2 changes had no relationship with global hemodynamic variables Objective : This study aim ed to investigate , in patients with severe sepsis , the correlation between central venous oxygen saturation and tissue oxygen saturation at different levels . Design : Prospect i ve observational study . Setting : General intensive care unit at an academic medical center in France . Patients : Thirty-eight patients with underresuscitated severe sepsis and septic shock on intensive care unit admission . Interventions : None . Measurements and Main Results : During early resuscitation according to the 6-hr bundles of the Surviving Sepsis Campaign guidelines , tissue oxygen saturation was recorded every other hour at the level of the thenar , masseter , and deltoid muscles along with central hemodynamics , arterial lactate concentrations , and central venous oxygen saturation . Over the 6-hr resuscitation period , thenar tissue oxygen saturation was consistently higher than masseter tissue oxygen saturation ( p = .04 ) and deltoid tissue oxygen saturation ( p = .002 ) , and masseter tissue oxygen saturation was consistently higher than deltoid tissue oxygen saturation ( p = .04 ) . Receiver operating characteristic curves analyses showed that masseter tissue oxygen saturation was better predictor of central venous oxygen saturation > 70 % than thenar tissue oxygen saturation ( area under the curve , 0.80 ; 95 % confidence interval 0.71−0.89 vs. 0.67 ; 95 % confidence interval 0.56–0.77 ; p = .02 ) . The crude 28-day mortality was 36.8 % . Receiver operating characteristic curve analysis showed that masseter tissue oxygen saturation ( area under the curve 0.87 ; 0.75−0.98 ) and deltoid tissue oxygen saturation ( area under the curve 0.88 ; 0.77−0.98 ) but not thenar tissue oxygen saturation ( area under the curve 0.66 ; 0.46–0.86 ) or central venous oxygen saturation ( area under the curve 0.56 ; 0.38–0.80 ) were strong predictors of 28-day mortality . Conclusions : This study suggested that in the early 6-hr resuscitation period , masseter tissue oxygen saturation accurately identified patients with severe sepsis and central venous oxygen saturation > 70 % . Both masseter tissue oxygen saturation and deltoid tissue oxygen saturation but not central venous oxygen saturation or thenar tissue oxygen saturation are strong predictors of 28-day mortality BACKGROUND : Tissue oximetry ( StO2 ) plus a vascular occlusion test is a noninvasive technology that targets indices of oxygen uptake and delivery . We hypothesize that prehospital tissue oximetric values and vascular occlusion test response can predict the need for in-hospital lifesaving interventions ( LSI ) . METHODS : We conducted a prospect i ve , blinded observational study to evaluate StO2 slopes to predict the need for LSI . We calculated the DeO2 slope using Pearson 's coefficients of regression ( r2 ) for the first 25 % of descent and the ReO2 slope using the entire recovery interval . The primary outcome was LSI defined as the need for emergent operation or transfusion in the first 24 hours of hospitalization . We created multivariable logistic regression models using covariates of age , sex , vital signs , lactate , and mental status . RESULTS : We assessed StO2 in a convenience sample of 150 trauma patients from April to November of 2009 . In-hospital mortality was 3 % ( 95 % confidence interval [ CI ] , 1.1–7.6 ) ; 31 % ( 95 % CI , 24–39 ) were admitted to the intensive care unit , 6 % ( 95 % CI , 2.8–11.1 ) had an emergent operation , and 10 % ( 95 % CI , 5.7–15.9 ) required transfusion . Decreasing DeO2 was associated with a higher proportion of patients requiring LSI . In the multivariate model , the association between the need for LSI and DeO2 , Glasgow Coma Scale , and age persists . CONCLUSION : Prehospital DeO2 is associated with need for LSI in our trauma population . Further study of DeO2 is warranted to determine whether it can be used as an adjunct triage criterion or an endpoint for resuscitation . LEVEL OF EVIDENCE : III , observational study BACKGROUND In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock , mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal -directed therapy ( EGDT ) , in which intravenous fluids , vasopressors , inotropes , and blood transfusions were adjusted to reach central hemodynamic targets , than among those receiving usual care . We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary . METHODS In 31 emergency departments in the United States , we r and omly assigned patients with septic shock to one of three groups for 6 hours of resuscitation : protocol -based EGDT ; protocol -based st and ard therapy that did not require the placement of a central venous catheter , administration of inotropes , or blood transfusions ; or usual care . The primary end point was 60-day in-hospital mortality . We tested sequentially whether protocol -based care ( EGDT and st and ard-
Output:
| StO2 more rapidly identifies occult shock in human patients compared to traditional methods , which can lead to earlier intervention in these patients .
VETERINARY DATA SYNTHESIS Veterinary studies involving tissue oxygen monitoring are limited , but the technology may have utility for identification of hemorrhagic shock earlier than changes in base excess , blood lactate concentration , or other traditional perfusion parameters .
CONCLUSION Tissue oxygen monitoring is most commonly performed utilizing a noninvasive , portable monitor , which provides real-time , continuous , repeatable StO2 measurements .
A decline in StO2 is an early indicator of shock in both human and veterinary patients .
Low StO2 values in human patients are associated with increased morbidity , mortality , and length of hospitalization , as well as the development of multiple organ system dysfunction and surgical site infections |
MS212254 | ***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: OBJECTIVES To examine the effects of progressive muscle relaxation and guided imagery on psychological and physiologic outcomes in adults with cardiovascular disease who were participating in a phase II cardiac rehabilitation program . To examine tension levels , practice patterns , and perceived helpfulness of the intervention reported by subjects . DESIGN Prospect i ve , quasi-experimental , with r and om group assignment within sites . Independent replication and extension of a study by Bohachik ( 1984 ) . SETTING Four midwestern hospital-based phase II cardiac rehabilitation programs . PATIENTS Fifty patients who within the preceding 12 weeks had had acute myocardial infa rct ion or coronary artery bypass surgery or both , studied during 6 weeks of participation in a phase II cardiac rehabilitation program . OUTCOME MEASURES Psychological measures included state and trait anxiety scores on the State-Trait Anxiety Inventory and reported symptoms on the Symptom Checklist-90-Revised . Physiologic measures were resting heart rate and blood pressure . Subjective tension levels before and after home practice , practice patterns , and perceived helpfulness of the intervention were examined . INTERVENTION Individual instruction session in progressive muscle relaxation and guided imagery at the phase II cardiac rehabilitation program , followed by daily home practice with audiotape instructions over a 6-week period . RESULTS No statistical differences at the p < or = 0.05 level were found in state anxiety scores or reported symptoms at study exit . However , reductions in mean subscale scores for interpersonal sensitivity ( t [ 19 ] = 2.11 , p < or = 0.05 ) and depression ( t [ 19 ] = 2.07 , p < or = 0.05 ) by paired t tests were found for the relaxation group ( RG ) . The two groups differed at study exit in resting heart rate ( t [ 42 ] = -2.02 , p < or = 0.05 ) by independent t tests and in systolic blood pressure ( F [ 1,42 ] = 5.13 , p < or = 0.05 ) by analysis of covariance . The RG had a mean resting heart rate 8.6 beats/min lower than that of the control group ( CG ) and also had within-group reductions in mean heart rate ( t [ 19 ] = 2.09 , p < or = 0.05 ) by paired t tests . Contrary to expectation , the CG had a 3.5 mm Hg lower mean systolic blood pressure and within-group reductions in systolic ( t [ 22 ] = 3.02 , p < 0.01 ) and diastolic ( t [ 22 ] = 3.83 , p < 0.01 ) blood pressure by paired t tests . CG subjects had a greater number of dose increases in cardiac medications and fewer dose reductions than did RG subjects , who also had a higher number of dose reductions . RG subjects reported frequent practice of the technique , rated it as helpful , and reported lower subjective tension levels after practice . CONCLUSIONS Findings in this study did not support those of Bohachik ( who reported lowered state anxiety and fewer somatization , interpersonal sensitivity , and depression symptoms ) . More instruction sessions on the relaxation method may have result ed in more positive outcomes . However , the within-group scores for interpersonal sensitivity and depression , the reduction in heart rate , and the receptivity of subjects to this intervention suggest that it may be a feasible and helpful adjunctive therapy for participants in a phase II cardiac rehabilitation program BACKGROUND There have been six r and omized controlled trials of psychological therapy with generalized anxiety disorder ( GAD ) using DSM-III-R and DSM-IV . All have used the Trait version of the Spielberger State-Trait Anxiety Inventory ( STAI-T ) as one of several outcome measures . Each study , however , employed different methods of calculating the clinical significance of outcomes making it difficult to reach a balanced appraisal of the efficacy of psychological treatment . METHODS Raw data on STAI-T scores at pre- , post- and follow-up were obtained for each of the six studies ( total N = 404 ) . Jacobson methodology for defining clinical ly significant change ( criterion c , reliable change index = 8 , cut-off point = 46 ) was used to allocate each patient to one of four outcomes : worse , unchanged , improved and recovered . The proportion of patients in each category was calculated for treatment conditions in each study and also for aggregate data across types of treatment . RESULTS A recovery rate of 40 % was found for the sample as a whole with 12 of the 20 treatment conditions obtaining very modest recovery rates of 30 % or less . Two treatment approaches -- individual cognitive behavioural therapy and applied relaxation -- do relatively well with overall recovery rates at 6-month follow-up of 50 - 60 % . CONCLUSIONS Jacobson methodology , in distinguishing between improvement and recovery on a st and ardized measure of general vulnerability to anxiety , provides a stringent but clinical ly more meaningful evaluation of the efficacy of psychological therapies with GAD than has been available hitherto . Systematic focus on either excessive worry or physiological arousal gives worthwhile results The purpose of this study was to evaluate the effect of stress management training on quality of life , functional capacity , and heart rate variability in elderly patients with New York Heart Association class I-III congestive heart failure ( CHF ) . While substantial research exists on stress management training for patients with coronary heart disease , there are few data on the value of psychosocial training on patients with CHF . Thirty-three multiethnic patients ( mean age , 66+/-9 years ) were assigned through incomplete r and omization to one of two treatment groups or a wait-listed control group . The 14 participants who completed the treatment attended eight training sessions during a 10-week period . The training consisted of 75-minute sessions adapted from the Freeze-Frame stress management program developed by the Institute of HeartMath . Subjects were assessed at baseline and again at the completion of the training . Depression , stress management , optimism , anxiety , emotional distress , and functional capacity were evaluated , as well as heart rate variability . Significant improvements ( p<0.05 ) were noted in perceived stress , emotional distress , 6-minute walk , and depression , and positive trends were noted in each of the other psychosocial measures . The 24-hour heart rate variability showed no significant changes in autonomic tone . The authors noted that CHF patients were willing study participants and their emotional coping and functional capacity were enhanced . This program offers a simple and cost-effective way to augment medical management of CHF . Given the incompleteness of CHF medical management and the exploding interest in complementary medical intervention , it seems imperative that further work in psychosocial treatment be undertaken One hundred fifty-six myocardial infa rct ion patients were r and omly assigned to either exercise plus relaxation and breathing therapy ( treatment A , n = 76 ) or to exercise training only ( treatment B , n = 80 ) . Effects on exercise testing showed a more pronounced training bradycardia and a remarkable improvement in ST abnormalities in treatment A ( p less than 0.005 ) . A model was developed to integrate the various exercise parameters into a single measure for training benefit . Approximately half the patients showed a training success , with a more positive and less negative outcome in treatment A ( p = 0.09 ) . The odds for failure were 0.25 for treatment A and 0.51 for treatment B ( odds ratio : 2.04 ; 95 % confidence interval , 0.94 to 4.6 ) . Thus the risk of failure was reduced by half when relaxation was added to exercise training . These results indicate that exercise training is not successful in all MI patients and that relaxation therapy enhances training benefit The objective of this study was to assess the impact of group-based stress management training on emotional well-being , functional status , social activity and chest pain in cardiac patients , within a r and omized controlled trial . Fifty acute myocardial infa rct ion and 50 coronary artery bypass patients were r and omized to experimental ( 27 myocardial infa rct ion and 23 coronary artery bypass ) and control ( 23 myocardial infa rct ion and 27 coronary artery bypass ) groups 3 months after infa rct ion or surgery . Experimental patients underwent a 10-week relaxation-based stress management programme , while the controls received normal care . Following assessment at the end of the treatment period , controls were offered the stress management programme . Follow-up data were collected 6 months post-treatment from both groups . Significantly greater improvements in emotional well-being as assessed on the Hospital Anxiety and Depression scale ( P < 0.005 ) and the Psychological General Well-being Index ( P < 0.001 ) were found in the experimental than control groups , and improvements were maintained at 6 month follow-up . Greater improvements were also recorded in experimental than control groups in activities of daily living ( P < 0.005 ) , satisfaction with health ( P < 0.025 ) , reports from spouses or relatives of patients ' emotional state ( P < 0.001 ) , and in disruption due to chest pain ( P < 0.001 ) . Similar responses to stress management were observed in myocardial infa rct ion and coronary artery bypass patients . When controls underwent treatment , they too showed significant reductions in anxiety and depression , but no changes in social or functional status . We conclude that stress management training may lead to improvements in the quality of life of myocardial infa rct ion and coronary artery bypass patients . Such programmes might usefully be made available even to patients who have participated in formal rehabilitation The authors report on the influence of autogenous training on blood pressure at rest and under stress conditions in patients with coronary heart disease following coronary bypass operation . We investigated the influence of autogenous training on the microcirculation and the left ventricular ejection fraction ( LVEF ) as well . The results showed a significant decrease in blood pressure at rest and also an increase of muscle circulation F and of LVEF OBJECTIVES To determine if cardiorespiratory biofeedback increases heart rate variability ( HRV ) in patients with documented coronary artery disease ( CAD ) . BACKGROUND Diminished HRV has been associated with increased cardiac morbidity and mortality . Evidence suggests that various lifestyle changes and pharmacologic therapies can improve HRV . The objective of this study was to determine if biofeedback increases HRV in patients with CAD . METHODS Patients with established CAD ( n = 63 ; mean age , 67 years ) were r and omly assigned to conventional therapy or to 6 biofeedback sessions consisting of abdominal breath training , heart and respiratory physiologic feedback , and daily breathing practice . HRV was measured by the st and ard deviation of normal-to-normal QRS complexes ( SDNN ) at week 1 ( pretreatment ) , week 6 ( after treatment ) , and week 18 ( follow-up ) . RESULTS Baseline characteristics were similar for the treatment and control groups . The SDNN for the biofeedback and control groups did not differ at baseline or at week 6 but were significantly different at week 18 . The biofeedback group showed a significant increase in SDNN from baseline to week 6 ( P < .001 ) and to week 18 ( P = .003 ) . The control subjects had no change from baseline to week 6 ( P = .214 ) and week 18 ( P = .27 ) . CONCLUSIONS Biofeedback increases HRV in patients with CAD and therefore may be an integral tool for improving cardiac morbidity and mortality rates OBJECTIVES Autogenic training ( AT ) is a method of autosuggestion with some potential for reducing anxiety . This study tests whether AT lowers anxiety levels experienced by patients undergoing coronary angioplasty . METHODS Fifty-nine patients were r and omly assigned to receive regular AT or no such therapy as an adjunct to st and ard care for 5 months . The primary outcome measure was State Anxiety at 2 months . Qualitative information was generated by face-to-face interviews . RESULTS State Anxiety showed a significant intergroup difference both at 2 and 5 months . This finding was corroborated by secondary outcome measures , for example , quality of life , and by qualitative information about patients ' experiences . The results do not allow us to determine whether the observed effects are specific to AT or of a nonspecific nature . CONCLUSIONS Our results suggest that AT may have a role in reducing anxiety of patients undergoing coronary angioplasty OBJECTIVE To conduct a feasibility study on stress management for patients with heart disease ; more specifically , to test the availability of patients , determine dropout rates , and investigate the sensitivity to change of a large number of psychologic and biologic stress indexes . DESIGN R and om assignment , two-group clinical trial . SETTING Pacific Northwest university-affiliated teaching hospital . PATIENTS Forty-five patients with heart disease ( mean age 56 years ) , who either had a myocardial infa rct ion or coronary bypass surgery . OUTCOME MEASURES Hostility , subjective distress , resting electrocardiogram , resting blood pressure and blood pressure reactivity to a psychologic stressor , and blood lipid , cortisol , and catecholamine levels . INTERVENTION Patients were r and omly assigned to either ( 1 ) exercise rehabilitation ( ER ) and an 8-week stress management ( SM ) program ( ER + SM ) or ( 2 ) ER only . Although the recruitment rate was satisfactory , 67 % of patients assigned to the control condition and 40 % of the SM subjects were not available for posttesting . RESULTS Computed effect sizes indicated that blood pressure reactivity to a psychologic challenge was reduced after treatment in the ER + SM group but not in ER group . The ER + SM group showed improvement in perceived health status and had clinical ly meaningful reductions in triglyceride levels , whereas the ER group did not . The ER group had a reduction in high-density lipoproteins , whereas the high-density lipoprotein levels of the ER + SM group did not change . CONCLUSIONS Patients r and omly assigned to a control condition may be less
Output:
| No effect was found on blood pressure or cholesterol .
Psychological outcome : state anxiety was reduced , trait anxiety was not , depression was reduced .
Cardiac effects : the frequency of occurrence of angina pectoris was reduced , the occurrence of arrhythmia and exercise induced ischaemia were reduced .
Return to work was improved .
Cardiac events occurred less frequently , as well as cardiac deaths .
With the exception of resting heart rate , the effects were small , absent or not measured in studies in which abbreviated relaxation therapy was given .
No difference was found between the effects of full or exp and ed relaxation therapy .
Conclusion Intensive supervised relaxation practice enhances recovery from an ischaemic cardiac event and contributes to secondary prevention . |
MS212255 | ***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 purpose of this study was to determine whether women in labor report less pain when they are in a vertical ( sitting or st and ing ) position than in a horizontal ( side-lying or supine ) position . Pain scores were obtained from 60 women in early labor ( dilation 2 - 5 cm ) who alternated between the two positions . The results show that about 35 % of women feel less front pain and 50 % feel less back pain when they are in a vertical position than in a horizontal position . The decrease in continuous back pain ( 83 % ) was particularly impressive , but the front and back pains associated with contractions were significantly diminished as well . These results , taken together with those of earlier studies , indicate that many women in early labor have less pain and are generally more comfortable in a vertical than in a horizontal position . Since early labor comprises a substantial proportion of the entire process of labor and delivery , any simple procedure which alleviates pain without danger to mother or child , such as shifting from a horizontal to a vertical position , should be promoted and employed There has been a relatively recent interest in alternative birthing techniques , including increased maternal mobility during labor . This literature review was pursued to evaluate the effect of upright maternal posture and ambulation on the first stage of labor . Although previous review s frequently assume that maternal ambulation speeds labor progress , the data presented in this review are not conclusive as to whether the upright maternal posture or ambulation during the first stage of labor shortens labor length or improves fetal outcome . However , it is clear that ambulation in labor is not harmful either to the mother or fetus . In addition , many investigators have reported that mobility in labor results in greater maternal comfort and ability to tolerate labor and decreased use of anesthesia and analgesia . Thus , acceptance of mobility in labor by patients and staff is generally reported . This information can serve as a guide to clinical management . However , there is a need for further analysis of the effect of maternal ambulation during labor , and specific suggestions for research are presented The cl aim that an upright maternal posture during labour improves the efficiency of the uterus to the benefit of both mother and fetus has been investigated in a r and omised prospect i ve study . 40 patients undergoing induction of labour were allocated to a recumbent group or an upright group . No differences were found between the groups in the length of labour , mode of delivery , requirements of oxytocic and analgesic drugs , or fetal and neonatal condition . Our data do not support calls to change conventional intrapartum nursing attitudes OBJECTIVE Our purpose was to test the hypothesis that the supine versus the lateral position is associated with a greater decrement in cardiac output after epidural analgesia in labor . STUDY DESIGN Twenty-one normal term subjects were r and omized to the left lateral or supine position in early labor . Cardiac output measured by the acetylene rebreathing method , stroke volume , heart rate , mean arterial pressure , and systemic vascular resistance were obtained at 5-minute intervals , beginning before a 500 ml intravenous fluid bolus ( baseline ) and ending 45 minutes after epidural injection . RESULTS Mean baseline supine versus lateral group differences were significant for 21 % lower cardiac output , 21 % lower stroke volume , 19 % higher mean arterial pressure , 50 % higher systemic vascular resistance , and equivalent heart rate . In the supine group fluid bolus result ed in significantly increased cardiac output and stroke volume , decreased mean arterial pressure and systemic vascular resistance , and unchanged heart rate . In the supine group cardiac output and stroke volume decreased significantly after epidural injection . The lateral position group exhibited no hemodynamic alterations after fluid bolus or epidural . CONCLUSIONS In contrast to the lateral position , the supine position is associated with a significant postepidural decrement in cardiac output , not identified by a change in heart rate . This likely reflects an inability to maintain stable preload volume in the supine position BACKGROUND Childbirth is an important life event for which a positive experience is important to many women . METHODS As secondary outcomes from the r and omised controlled Comparative Obstetric Mobile Epidural Trial , various aspects of satisfaction were assessed in women who had one of three types of regional analgesia ( two of which were low-dose techniques and a high-dose control using 0.25 % epidural bupivacaine ) and a comparison group who did not have epidural analgesia , shortly after delivery and 12 months later . RESULTS The predominant finding was satisfaction with spontaneous vaginal delivery whatever the mode of analgesia . The overall immediate and long-term satisfaction was similar for all three neuraxial techniques . Satisfaction with the speed of pain relief and the amount of mobility were significantly greater for the combined spinal-epidural technique compared with the low-dose infusion ( P<0.001 ) . The degree of control felt by women who had combined spinal-epidural analgesia was greater than with the high-dose ( P<0.05 ) . Women in the non-epidural comparison group did not report a greater feeling of control . Among those who delivered spontaneously , more women in the combined spinal-epidural group ( 30 % ) felt in full control compared with the high-dose group ( 17 % ) ( P<0.05 ) . By comparison 22 % in the low-dose infusion group and only 15 % who had no epidural felt in full control . CONCLUSIONS Whilst satisfaction with the experience of childbirth appears intimately related to the attainment of a spontaneous delivery , mobile epidurals enhance women 's feeling of control in labour and are popular for future choice of regional analgesia Telemetry and conventional cardiotocography were compared by monitoring the labor of 60 patients with an uneventful pregnancy and delivery in the 38th-42nd week of pregnancy . 31 patients were monitored by telemetry and 29 by cardiotocography . The patients were matched for age ( + /- 5 years ) , duration of pregnancy ( + /- 7 days ) and parity ( I or II ) . The husb and attended labor and delivery in 42 % of the cases in the telemetry group and in 59 % of the cases in the control group . Induction of labor by amniotomy was performed in 32 % of the cases in the telemetry group and in 24 % of the cases in the cardiotocography group . The patients monitored subjective pain every half hour during the opening phase . The telemetric patients were encouraged to sit or walk during the first stage . No maternal or fetal complications occurred . All infants were born in good condition with APGAR scores greater than or equal to 7 recorded at one and five minutes . There were 4 operative deliveries in the telemetry group and 5 in the control group . Indications for these were maternal or uterine exhaustion with the exception of two control patients where fetal asphyxia was suspected . The duration of the first stage of labor did not differ significantly between the telemetry and the cardiotocography groups . The telemetric patients received less analgesics than the controls but this difference was not significant . In spite of less analgesia in the telemetry group , the secondparas of the telemetry group experienced significantly less ( p less than 0.01 ) labor pain than the controls . In addition , the secondparas of the telemetry group considered the present labor less painful than the previous one significantly more often than the controls . Among the primiparous patients there was no difference in the amount of pain experienced by the patients Our purpose was to study the feasibility and results of encouraging ambulation during the first stage of labor in routine obstetric practice . Six-hundred and thirty low risk mothers with intact membranes were r and omized into an ambulant and a control group . The results in the ambulant group were not better than in the control group . Our study suggests that , in principle ambulation may be beneficial , but that the concomitant changes in practice should be different from those in our study A prospect i ve study of 300 consecutive deliveries has been made to assess the benefits and acceptability of ambulation during spontaneous labour . Ambulation during the first stage occurred in 48 patients with 55 non‐ambulant patients acting as controls . No difference in the length of first or second stage , incidence of fetal distress or mode of delivery was observed . In spite of the lack of apparent advantage to the fetal condition , ambulation was acceptable to both patients and nursing staff and should not be discouraged Objectives To determine whether snoring , sleep position , and other sleep practice s in pregnant women are associated with risk of late stillbirth . Design Prospect i ve population based case-control study . Setting Auckl and , New Zeal and Participants Cases : 155 women with a singleton late stillbirth ( ≥28 weeks ’ gestation ) without congenital abnormality born between July 2006 and June 2009 and booked to deliver in Auckl and . Controls : 310 women with single ongoing pregnancies and gestation matched to that at which the stillbirth occurred . Multivariable logistic regression adjusted for known confounding factors . Main outcome measure Maternal snoring , daytime sleepiness ( measured with the Epworth sleepiness scale ) , and sleep position at the time of going to sleep and on waking ( left side , right side , back , and other ) . Results The prevalence of late stillbirth in this study was 3.09/1000 births . No relation was found between snoring or daytime sleepiness and risk of late stillbirth . However , women who slept on their back or on their right side on the previous night ( before stillbirth or interview ) were more likely to experience a late stillbirth compared with women who slept on their left side ( adjusted odds ratio for back sleeping 2.54 ( 95 % CI 1.04 to 6.18 ) , and for right side sleeping 1.74 ( 0.98 to 3.01 ) ) . The absolute risk of late stillbirth for women who went to sleep on their left was 1.96/1000 and was 3.93/1000 for women who did not go to sleep on their left . Women who got up to go to the toilet once or less on the last night were more likely to experience a late stillbirth compared with women who got up more frequently ( adjusted odds ratio 2.28 ( 1.40 to 3.71 ) ) . Women who regularly slept during the day in the previous month were also more likely to experience a late stillbirth than those who did not ( 2.04 ( 1.26 to 3.27 ) ) . Conclusions This is the first study to report maternal sleep related practice s as risk factors for stillbirth , and these findings require urgent confirmation in further studies An investigation was conducted on the maintenance of control in labor , using a 28-item revised Labor Agentry Scale with an estimated reliability of .98 . Thirty low-risk subjects who had attended prenatal classes were r and omly allocated during labor to either the control group , which received st and ard electronic fetal monitoring , or the experimental group , which received radiotelemetric fetal monitoring . Significant differences ( The purpose of this study was to determine if women who assumed upright positions during the phase of maximum slope would have a shorter phase of maximum slope in their labor and experience more comfort than women who assumed recumbent positions . Forty laboring women were r and omly assigned to either an upright or recumbent position group . Subjects assumed the positions of their assigned group during the phase of maximum slope in their labor ( cervical dilatation from 4 cm to 9 cm ) . Every hour during the phase of maximum slope , each subject was examined vaginally to determine her cervical dilatation and assessed for her level of comfort using the Maternal Comfort Assessment Tool . Women in the upright position group had a significantly shorter phase of maximum slope in labor , but did not significantly differ in comfort level from women in the recumbent group . Newborn Apgar scores were not significantly different between the two groups . Nurses need to be aware that the upright labor positions have the distinct advantages of facilitating efficient uterine contractions and reducing the duration of the phase of maximum slope in labor , with no increase in the discomfort experienced or adverse effect on newborn well-being Background Ambulatory epidural analgesia ( AEA ) is a popular choice for labor analgesia because ambulation reportedly increases maternal comfort , increases the intensity of uterine contractions , avoids inferior vena cava compression , facilitates fetal head descent , and relaxes the pelvic musculature , all of which can shorten labor . However , the preponderance of evidence suggests that ambulation during labor is not associated with these benefits . The purpose of this study is to determine whether ambulation with AEA decreases labor duration from the time of epidural insertion to complete cervical dilatation . Methods In this prospect i ve , r and omized study , 160 nulliparous women with AEA were r and omly assigned to one of two groups : AEA with ambulation and AEA without ambulation . AEA blocks were initiated with 15–20 ml ropivacaine ( 0.07 % ) plus 100 & mgr;g fentanyl , followed by a continuous infusion of 0.07 % ropivacaine plus 2 & mgr;g/ml fentanyl at 15–20 ml/h . Maternal measured variables included ambulation time , time from epidural insertion to complete dilatation , stage II duration , pain Visual Analogue Scale scores , and mode of delivery . APGAR scores were recorded at 1 and 5 min . Results are expressed as mean ± SD or median and analyzed using the t test , chi-square , or the Mann – Whitney test at P ≤ 0.05 . Results The ambulatory group walked 25.0 ± 23.3 min , sat upright 40.3 ± 29.7 min , or both . Time from epidural insertion to complete dilatation was 240.9 ± 146.1 min in the ambulatory group and 211.9 ± 133.9 min in the nonambulatory group ( P = 0.206 ) . Conclusion Ambulatory epidural analgesia with walking or sitting does not shorten labor duration from the time of epidural insertion to complete cervical dilatation BACKGROUND Dense perineal block from epidural analgesia increases the risk of urinary catheterization in
Output:
| There were no significant differences between groups for other outcomes including duration of the second stage of labour , or other outcomes related to the well being of mothers and babies .
AUTHORS ' CONCLUSIONS There is clear and important evidence that walking and upright positions in the first stage of labour reduces the duration of labour , the risk of caesarean birth , the need for epidural , and does not seem to be associated with increased intervention or negative effects on mothers ' and babies ' well being . |
MS212256 | ***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 majority of clinical trials of cognitive-behavioral therapy ( CBT ) for schizophrenia have used individual therapy to target positive symptoms . Promising results have been found , however , for group CBT interventions and other treatment targets like psychosocial functioning . CBT for functioning in schizophrenia is based on a cognitive model of functional outcome in schizophrenia that incorporates dysfunctional attitudes ( eg , social disinterest , defeatist performance beliefs ) as mediators between neurocognitive impairment and functional outcome . In this report , 18 clinical trials of CBT for schizophrenia that included measures of psychosocial functioning were review ed , and two-thirds showed improvements in functioning in CBT . The cognitive model of functional outcome was also tested by examining the relationship between social disinterest attitudes and functional outcome in 79 people with schizophrenia r and omized to either group cognitive-behavioral social skills training or a goal -focused supportive contact intervention . Consistent with the cognitive model , lower social disinterest attitudes at baseline and greater reduction in social disinterest during group therapy predicted better functional outcome at end of treatment for both groups . However , the groups did not differ significantly with regard to overall change in social disinterest attitudes during treatment , suggesting that nonspecific social interactions during group therapy can lead to changes in social disinterest , regardless of whether these attitudes are directly targeted by cognitive therapy interventions OBJECTIVE This study evaluated the effects of the illness management and recovery program on mental illness and functional outcomes of persons with serious mental illness who were receiving supportive housing services . METHODS A r and omized controlled trial was conducted with 104 persons with serious mental illness who were assigned either to illness management classes for six months or to a waitlist control group , with follow-up assessment s conducted six months posttreatment . Assessment s included self-reports , nonblinded clinical ratings , and blinded interview ratings and included the domains of illness management , symptoms , psychosocial functioning , hospitalizations , and substance abuse and dependence . RESULTS Participants assigned to the program showed significantly greater improvements than the control group in self-reported and clinician ratings of illness management , interview-based ratings of symptoms on the Brief Psychiatric Rating Scale , and interview-based ratings of psychosocial functioning on the abbreviated Quality of Life Scale . Participants in both groups improved in self-ratings of symptom distress and had low rates of hospitalization and substance abuse over the course of the study . CONCLUSIONS The results suggest that the program was effective at improving illness management and functional outcomes for persons with serious mental illness who were receiving supportive housing services OBJECTIVE This study examined the effectiveness of an Internet parenting education and support intervention among mothers with a serious mental illness ( SMI ) . METHODS Sixty mothers diagnosed with a schizophrenia spectrum or mood disorder who had primary /shared custody for a child 18 or younger were enrolled in a r and omized controlled trial ( RCT ) with two conditions . The experimental condition involved participation in the online parental education course and a listserv co-moderated by a parent with a mental illness and a mental health professional . The control condition involved participation in online education healthy lifestyle course . St and ardized measures were used at baseline and 3 months to assess outcomes . Using an intent-to-treat approach , group differences over time were assessed using a two-tailed independent sample t test on all dependent variables , including parental efficacy , skills , coping , support , and stress . RESULTS Participation in an online parenting intervention for mothers with a SMI enhanced parenting and coping skills , and decreased parental stress . No support was found for improved efficacy or support . CONCLUSION This RCT establishes that mothers with a SMI are interested in and capable of receiving online parenting education and support . Findings demonstrate that an online parenting intervention can improve parenting and coping skills and decrease parental stress Objectives : To investigate the effectiveness of a long established intervention , occupational therapy for people with psychotic conditions , and to inform future research design s. Design : A pilot r and omized controlled trial . Setting : Two community mental health teams in a UK city . Participants : Forty-four adults with schizophrenia or other psychotic conditions , and functional problems . Interventions : Twelve months of individualized occupational therapy in community setting s , as an adjunct to usual care and compared to treatment as usual . A two to one r and omization ratio was used in favour of occupational therapy . Outcome measures : Social Functioning Scale , Scale for the Assessment of Negative Symptoms and employment . Results : Both groups ' scores on Social Functioning Scale and Scale for the Assessment of Negative Symptoms showed significant improvement over 12 months . The Social Functioning Scale overall mean difference for occupational therapy was 2.33 , P=0.020 and for treatment as usual was 6.17 , P=0.023 . The Scale for the Assessment of Negative Symptoms total mean difference for occupational therapy was -16.25 , P<0.001 and for treatment as usual was -17.36 , P= 0.011 . There were no differences between the two groups on any of the outcome measures . After 12 months the occupational therapy group showed clinical ly significant improvements that were not apparent in the control group . These were in four subscales of the Social Functioning Scale : relationships , independence performance , independence competence and recreation . Out of 30 people receiving occupational therapy those with a clinical level of negative symptoms reduced from 18 ( 64 % ) to 13 ( 46 % ) , P=0.055 . Conclusion : This pilot study suggested that individualized occupational therapy may contribute to recovery but more focus is recommended on people 's cognitive abilities and employment BAKGROUND To investigate the efficacy of the " Life Adaptation Skills Training ( LAST ) " program for persons with depression . METHODS Sixty-eight subjects with depressive disorder were recruited from psychiatric outpatient clinics in Taipei city and were r and omly assigned to either an intervention group ( N=33 ) , or a control group ( N=35 ) . The intervention group received 24-sessions of the LAST program , as well as phone contact mainly related to support for a total of 24 times . The control group only received phone contact 24 times . The primary outcome measure utilized was the World Health Organization Quality of Life-BREF-Taiwan version . Secondary outcome measures included the Occupational self- assessment , the Mastery scale , the Social support question naire , the Beck anxiety inventory , the Beck depression inventory-II , and the Beck scale for suicide ideation . The mixed-effects linear model was applied to analyze the incremental efficacy of the LAST program , and the partial eta squared ( ηp(2 ) ) was used to examine the within- and between- group effect size . RESULTS The subjects who participated in the LAST program showed significant incremental improvements with moderate to large between-group effect sizes on their level of anxiety ( -5.45±2.34 , p<0.05 ; ηp(2)=0.083 ) and level of suicidal ideation ( -3.09±1.11 , p<0.01 ; ηp(2)=0.157 ) when compared to the control group . The reduction of suicidal ideations had a maintenance effect for three months after the end of intervention ( -3.44±1.09 , p<0.01 ) , with moderate between-group effect sizes ( ηp(2)=0.101 ) . Both groups showed significant improvement on overall QOL , overall health , physical QOL , psychological QOL , level of anxiety , and level of depression . The within-group effect sizes achieved large effects in the intervention group ( ηp(2)=0.328 - 0.544 ) , and were larger than that of the control group . LIMITATIONS A small sample size in the study , a high dropout rate , lower compliance rates for the intervention group , and lacking of true control group . CONCLUSIONS The occupation-based LAST program , which focuses on lifestyle rearrangement and coping skills enhancement , could significantly improve the level of anxiety and suicidal ideations for persons with depression BACKGROUND Social cognition difficulties in schizophrenia are seen as a barrier to recovery . Intervention tackling problems in this domain have the potential to facilitate functioning and recovery . Social Cognition and Interaction Training ( SCIT ) is a manual-based psychological therapy design ed to improve social functioning in schizophrenia . AIMS The aim of this study is to evaluate the feasibility and acceptability of a modified version of SCIT for inpatient forensic wards . The potential benefits of the intervention were also assessed . METHOD This study is a r and omized single blind controlled design , with participants r and omized to receive SCIT ( N = 21 ) or treatment as usual ( TAU ; N = 15 ) . SCIT consisted of 8-week therapy sessions twice per week . Participants were assessed at week 0 and one week after the intervention on measures of social cognition . Feasibility was assessed through group attendance and attrition . Participant acceptability and outcome was evaluated through post-group satisfaction and achievement of social goals . RESULTS The intervention was well received by all participants and the majority reported their confidence improved . The SCIT group showed a significant improvement in facial affect recognition compared to TAU . Almost all participants agreed they had achieved their social goal as a result of the intervention . CONCLUSIONS It is feasible to deliver SCIT in a forensic ward setting ; however , some adaptation to the protocol may need to be considered in order to accommo date for the reduced social contact within forensic wards . Practice of social cognition skills in real life may be necessary to achieve benefits to theory of mind and attributional style Sleep disturbance is a common problem associated with depression , and cognitive-behavioral therapy ( CBT ) is a more common behavioral intervention for sleep problems . The present study compares the effect of a newly developed Chinese Chan-based intervention , namely Dejian mind-body intervention ( DMBI ) , with the CBT on improving sleep problems of patients with depression . Seventy-five participants diagnosed with major depressive disorder were r and omly assigned to receive 10 weekly sessions of CBT or DMBI , or placed on a waitlist . Measurements included ratings by psychiatrists who were blinded to the experimental design , and a st and ardized question naire on sleep quantity and quality was obtained before and after the 10-week intervention . Results indicated that both the CBT and DMBI groups demonstrated significantly reduced sleep onset latency and wake time after sleep onset ( effect size range = 0.46–1.0 , P ≤ 0.05 ) as compared to nonsignificant changes in the waitlist group ( P > 0.1 ) . Furthermore , the DMBI group , but not the CBT or waitlist groups , demonstrated significantly reduced psychiatrist ratings on overall sleep problems ( effect size = 1.0 , P = 0.00 ) and improved total sleep time ( effect size = 0.8 , P = 0.05 ) after treatment . The present findings suggest that a Chinese Chan-based mind-body intervention has positive effects on improving sleep in individuals with depression OBJECTIVE We evaluated the effects of cognitive behavioral therapy for insomnia ( CBT-I ) in in patients with a diagnosis of depression and comorbid insomnia . METHOD This study used a prospect i ve , parallel-group design . The experimental group received CBT-I for no more than 90 min once weekly for 6 weeks and the control group only have health education manuals for insomnia . The following question naires were administered at baseline : the Hamilton Rating Scale for Depression ( HAM-D ) , Dysfunctional Beliefs and Attitudes about Sleep ( DBAS ) , Presleep Arousal Scale ( PSAS ) , Sleep Hygiene Practice ( SHP ) , and Pittsburgh Sleep Quality Index . The question naires were readministered after the completion of the 6-wk CBT-I intervention and 1 month following the completion of CBT-I , to determine the effects of the CBT-I intervention over time . The analysis of Generalized Estimation Equations was identified the difference between the experimental group and the control group by controlling for the variables in BZD dose and propensity score of gender , age , and the scores for the DBAS-16 , PSAS , SHPS , and HAM-D. RESULTS Consequently , the significant difference in the PSQI scores was observed at the 1-month follow-up assessment however , no significant intergroup difference in the PSQI scores was found at the completion of the CBT-I intervention between two groups . CONCLUSIONS As a conclusion , we found that overall sleep quality significantly improved in patients who received CBT-I after we controlled for the BZD dose and propensity score , which suggests that CBT-I may represent a useful clinical strategy for improving sleep quality in patients with depression and comorbid insomnia The aim of this study was to evaluate the impact of a sailing rehabilitation program on the quality of life ( QoL ) in a sample of patients with severe mental disorders . The study adopted a r and omized , crossover , waiting-list controlled design . The participants enrolled in the study were out patients diagnosed with severe chronic mental disorders . The participants ( N=40 ) exposed to rehabilitation with sailing took part in a series of supervised cruises near the gulf of Cagliari , South Sardinia , and showed a statistically significant improvement of their quality of life compared to the control group . This improvement was comparable to the improvement in psychopathologic status and social functioning as shown in a previous report of the same research project . The improvement was maintained at follow-up only during the trial and for a few months later : after 12 months , patients returned to their baseline values and their quality of life showed a worsening trend . This is the first study to show that rehabilitation with sailing may improve the quality of life of people with severe chronic mental disorders . In all likelihood , a program grounded on learning how to manage a sailing vessel - during which patients perform cruises that emphasize the exploration of the marine environment by sailing - might be interesting enough and capture the attention of
Output:
| The review yielded strong evidence for psychoeducation and occupation‐ and cognitive‐based interventions , moderate evidence for skills‐based interventions , and limited evidence for technology‐supported interventions .
NA ; Effective occupational therapy interventions help people with SMI to engage in everyday living activities , leisure , social participation , and rest and sleep |
MS212257 | ***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: Background Persistent pain is a challenging clinical problem after breast cancer treatment . After surgery , inflammatory pain and nociceptive input from nerve injury induce central sensitization which may play a role in the genesis of persistent pain . Using quantitative sensory testing , we tested the hypothesis that adding COX-2 inhibition to st and ard treatment reduces hyperalgesia after breast cancer surgery . A secondary hypothesis was that patients developing persistent pain would exhibit more postoperative hyperalgesia . Methods 138 women scheduled for lumpectomy/mastectomy under general anesthesia with paravertebral block were r and omized to COX-2 inhibition ( 2x40 mg parecoxib on day of surgery , thereafter 2x200 mg celecoxib/day until day five ) or placebo . Preoperatively and 1 , 5 , 15 days and 1 , 3 , 6 , 12 months postoperatively , we determined electric and pressure pain tolerance thresholds in dermatomes C6/T4/L1 and a 100 mm VAS score for pain . We calculated the sum of pain tolerance thresholds and analyzed change in these versus preoperatively using mixed models analysis with factor medication . To assess hyperalgesia in persistent pain patients we performed an additional analysis on patients reporting VAS>30 at 12 months . Results 48 COX-2 inhibition and 46 placebo patients were analyzed in a modified intention to treat analysis . Contrary to our primary hypothesis , change in the sum of tolerance thresholds in the COX-2 inhibition group was not different versus placebo . COX-2 inhibition had an effect on pain on movement at postoperative day 5 ( p<0.01 ) . Consistent with our secondary hypothesis , change in sum of pressure pain tolerance thresholds in 11 patients that developed persistent pain was negative versus patients without pain ( p<0.01 ) from day 5 to 1 year postoperatively . Conclusions Perioperative COX-2 inhibition has limited value in preventing sensitization and persistent pain after breast cancer surgery . Central sensitization may play a role in the genesis of persistent postsurgical pain In a clinical double-blind study , the analgesic efficacy and the side-effects of nimesulide ( Aulin , CAS 51803 - 78 - 2 ) and naproxen administered to 68 patients affected by advanced cancer pain were compared . Patients were treated with non-steroidal anti-inflammatory drugs according to the first step of the pharmacological analgesic scale of the WHO . The dose administered was 200 mg b.i.d . ( every 12 h ) for nimesulide and 500 mg b.i.d . ( every 12 h ) for naproxen . From this study the analgesic effect and the tolerability of the two drugs appeared to be similar . Both drugs result ed to be effective with a low incidence of adverse events that may be related to their use The analgesic efficacy of ketorolac tromethamine was compared to placebo in 126 patients suffering moderate or severe chronic pain due to cancer in a double-blind parallel r and omized study . Ketorolac was administered intramuscularly in doses of 10 , 30 or 90 mg . Pain intensity and pain relief were assessed for 6 hours by scoring st and ard verbal scales and an overall assessment of the medication was given by the patients and the observer on completion of the study . Each dose of ketorolac was statistically superior to placebo for the sum of pain intensity difference ( SPID ) but no difference was seen between the three ketorolac regimens . When the ketorolac groups are combined , there was a significantly better pain relief as compared to placebo . The global evaluation scores were also statistically superior in the ketorolac groups combined than in the placebo group . A total of 15 patients reported minor adverse events , 10 being after ketorolac doses . This study shows that single intramuscular doses of ketorolac of 10 mg and above are effective in the relief of cancer pain , and are associated with a low incidence of side-effects Objectives This study aims to evaluate the efficacy of methadone as substitute for morphine and to investigate if the addition of acetaminophen could reduce the time to attain an equianalgesic dose of methadone and /or to improve the level of pain control in oncologic patients . Patients and methods Fifty patients on stable doses of morphine for 1 week were switched to methadone using a “ stop – start ” strategy and r and omized in a double-blind fashion to receive either acetaminophen ( 750 mg PO every 6 hours ) or placebo for a 7-day period . We collected data regarding level of pain , side effects , and quality of life . Results Substitution of morphine for methadone result ed in a significant reduction in constipation ( p < 0.001 ) and xerostomia ( p = 0.03 ) . There was also an improvement in the numeric pain scale ( p = 0.03 ) as well as a significant improvement in the functional level and symptomatology according to the QLQ-C30 question naire . Addition of acetaminophen did not improve pain control or reduce the time of stabilization of analgesia once methadone was introduced . At the end of the study , most patients ( 70.8 % , p = 0.001 ) preferred methadone to morphine . Conclusions Early switching from morphine to methadone was a safe and efficient strategy for the reduction of side effects and improvement of analgesia , allowing for a comfortable dosing regimen . In this scenario , the association with acetaminophen did not improve pain control or reduce the time to achieve an equianalgesic dose of methadone Benzydamine hydrochloride rinse reduced pain associated with radiation mucositis when it was used during the course of radiation therapy . Fewer patients using benzydamine rinse required systemic analgesics . All patients using benzydamine tolerated the rinse well and continued with regular rinsing throughout the course of radiation therapy . Benzydamine hydrochloride is currently undergoing clinical trials in the United States for application for approval from the Food and Drug Administration The role of non-steroidal anti-inflammatory drugs ( NSAIDs ) in cancer pain has been well established in the treatment of mild pain and in association with opioids in the treatment of moderate to severe pain . The aim of this study was to verify the effects of NSAIDs on morphine escalation in advanced cancer patients with pain followed-up at home and to assess the pharmacoeconomic implication s. A prospect i ve r and omised controlled study was carried out in 156 consecutive advanced cancer patients with pain followed-up at home in the period December 1999-December 2000 . In this group of patients , 47 were selected with pain progression after 1 week of opioid stabilisation . Patients were r and omly assigned to one of two groups : group ' O ' patients were treated with continuing opioid escalation according to their clinical needs ; group ' OK ' received ketorolac 60 mg/daily orally ( p.o . ) in three doses and then continued opioid escalation according to their clinical situation . Performance status , doses of morphine before and after starting treatment , mean weekly pain intensity ( assessed by means of a numerical scale from 0 to 10 ) , mean weekly symptoms intensity , adverse effects and pain mechanisms were recorded . Moreover , drug costs per day in both groups were calculated . Patients who received ketorolac in addition to morphine showed a better analgesia after a week in comparison to the group treated with morphine only ( P=0.005 ) . Thereafter , morphine escalation was slower and the maximum morphine dose was lower in the group treated with ketorolac . The incidence and the severity of gastric discomfort was more evident in patients treated with ketorolac , while constipation was significantly increased in patients who received morphine only . Drug costs per day were similar in both groups ; statistical differences were observed in patients who started on lower morphine doses ( < 100 mg/daily ) in the two groups ( 4.3 in the ketorolac-morphine group versus 3.4 in the morphine group ; P=0.012 ) . The use of NSAIDs reduces the need for an opioid dose escalation or allows the use of lower doses . Their use is associated with a more intense gastric discomfort , but results in less opioid-related constipation . The eventual additive cost for NSAIDs therapy is negligible , especially in patients taking high doses of morphine In a controlled double blind study of analgesics for the pain of gastrointestinal cancer , aspirin ( 650 mg ) was significantly more effective than placebo and superior to orally used codeine sulfate ( 60 mg ) . The effectiveness of aspirin was not specific for carcinoma of the pancreas , however , because the same pattern of pain relief was found in colonic carcinoma Introduction Adjunct nonopioid analgesics may improve pain control in patients with cancer needing morphine or its derivates . Dypirone is a cheap nonopioid analgesic widely used in many countries . Objective The objective of the study was to evaluate , whenever morphine was started , if associating dipyrone with it would improve pain control and if this effect was time dependent . Material s and methods This is a double-blind placebo-controlled r and omized crossover study . Thirty-four ambulatory cancer patients experiencing cancer-related pain for which oral morphine was to be started at the dose of 10 mg orally ( PO ) every 4 h were r and omized to take either dipyrone 500 mg PO every 6 h or placebo . After 48 h , patients would be switched from dipyrone to placebo and vice versa . Pain was the primary outcome and was measured using a visual analogue scale before starting medications , at 48 and 96 h. Results We r and omized 16 patients to start with placebo ( group 1 ) and 18 with dipyrone ( group 2 ) . Pain scores for groups 1 and 2 were at baseline : 7.31 ± 0.29 vs 6.88 ± 0.28 ( p = 0.3 ) , at 48 h : 7.06 ± 0.32 vs 5.5 ± 0.31 ( p = 0.001 ) , and at 96 h : 3.18 ± 0.39 vs 1.94 ± 0.37 ( p = 0.03 ) . Both groups had significant improvements in pain scores after introducing dipyrone ( p < 0.001 , for both ) . Main toxicities were nausea , vomiting , epigastric pain , and myalgias . Twenty-eight patients chose dipyrone , four placebo , and two were indifferent . Conclusions We conclude that dipyrone adds significantly to the analgesic effect of morphine and , when given at the time of starting morphine , results in better pain scores even after dipyrone is discontinued Objective The present study aim ed to examine the effectiveness of intravenous administration of paracetamol added to morphine in the control of cancer pain and its possible contribution as reduction of opioid consumption and opioid-related side effects . Material s and methods A total of 43 patients with chronic cancer pain without neuropathic origin aged between 18 and 76 years and receiving step 2 treatment according to the World Health Organization analgesic ladder were included . Patients were r and omized to receive intravenous administration of saline ( control ) or 1 g of paracetamol on top of morphine . Visual analog scale ( VAS ) , patient rating index ( PRI ) , Eastern Cooperative Oncology Group ( ECOG ) status , patient satisfaction , and safety were evaluated . Main results Both treatments result ed in improved VAS and PRI scores compared to baseline . However , groups did not differ in terms of VAS and PRI scores , morphine consumption , side-effect frequencies , laboratory values , ECOG status , and patient satisfaction . Conclusions Although safe and there are signals for a true analgesic efficacy , our results failed to confirm any benefits of add-on treatment with intravenous administration of paracetamol . However , the study was underpowered , and future studies in this important area need to be wary of background noise and the risk of a type II error As professionals , we want to use the best treatments ; as patients , we want to be given them . Knowing whether an intervention works ( or does not work ) is fundamental to clinical decision making . However , clinical decision making involves more than simply taking published results of research directly to the bedside . Physicians need to consider how similar their patients are to those in the published studies , to take the values and preferences of their patients into account , and to consider their own experience with a given test or treatment . Evidence from clinical research is becoming increasingly important in medical- practice decisions as more and better evidence is published . But when is the evidence strong enough to justify changing a practice ? Individual studies that involve only small numbers of patients may have results that are distorted by the r and om play of chance and thus lead to less than optimal decisions . As is clear from other papers in this series , systematic review s identify , critically appraise , and review all the relevant studies on a clinical question and are more likely to give a valid answer . They use explicit methods and quality st and ards to reduce bias . Their results are the closest we can come to reaching the truth given our current state of knowledge . The questions about an intervention that a systematic review should answer are the following : 1 . Does it work ? 2 . If it works , how well does it work in general and compared with placebo , no treatment , or other interventions that are currently in use ? 3 . Is it safe ? 4 . Will it be safe and effective for my patients ? Whereas the critical appraisal and qualitative synthesis provided by review articles can be interpreted directly , the numerical products of quantitative review s can be more difficult to underst and and apply in daily clinical practice . This paper provides guidance on how to interpret the numerical and statistical results of systematic review s , translate these results into more underst and able terms , and apply them directly to individual patients .
Output:
| There was no convincing evidence for satisfactory pain relief by acetaminophen alone or in combination with strong opioids .
We found substantial evidence of moderate quality for a satisfactory pain relief in cancer by non-steroidal anti-inflammatory drugs ( NSAIDs ) , flupirtine , and dipyrone compared with placebo or other analgesics .
There was no evidence for a superiority of one specific non-opioid .
There was moderate quality of evidence for a similar pain reduction by NSAIDs in the usual dosage range compared with up to 15 mg of morphine or opioids of equianalgesic potency .
The combination of NSAID and step III opioids showed a beneficial effect , without a decreased tolerability .
There is scarce evidence concerning the combination of NSAIDs with weak opioids .
Non-steroidal anti-inflammatory drugs , flupirtine , and dipyrone can be recommended for the treatment of cancer pain either alone or in combination with strong opioids .
The use of acetaminophen in the palliative setting can not be recommended .
There is a lack of evidence regarding pain treatment by non-opioids in specific cancer entities |
MS212258 | ***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: BACKGROUND The clinical oral examination ( COE ) is the criterion st and ard for the initial detection of oral lesions that harbor dysplasia or oral squamous cell carcinoma ( OSCC ) at an early stage when they are most treatable . The authors conducted a systematic review to assess the effectiveness of the COE in predicting histologic diagnosis of dysplasia or OSCC . METHODS The authors conducted automated search es of PubMed , Web of Knowledge , and the Cochrane Library from 1966 through 2010 for r and omized controlled trials and observational studies that included the terms " oral mucosal lesion screening " and " oral lesions . " They determined the quality ( sensitivity , specificity , positive predictive value , negative predictive value and diagnostic odds ratio ) of selected studies by using the Quality Assessment of Diagnostic Accuracy Studies tool . RESULTS The overall diagnostic odds ratio was 6.1 ( 95 % confidence interval , 2.1 - 17.6 ) ; therefore , the COE was considered to have poor overall performance as a diagnostic method for predicting dysplasia and OSCC . CLINICAL IMPLICATION S On the basis of the available literature , the authors determined that a COE of mucosal lesions generally is not predictive of histologic diagnosis . The fact that OSCCs often are diagnosed at an advanced stage of disease indicates the need for improving the COE and for developing adjuncts to help detect and diagnose oral mucosal lesions BACKGROUND The aim of this prospect i ve study was to evaluate the efficacy of a new form of autofluorescence imaging and tissue reflectance spectroscopy ( Identafi , DentalEZ ) in examining patients with oral mucosal lesions . METHODS The authors examined 88 patients with 231 oral mucosal lesions by conventional oral examination ( COE ) using white-light illumination and ×2.5 magnification loupes , followed by examination using Identafi . The authors noted fluorescence visualization loss , the presence of blanching , and diffuseness of vasculature . They performed incisional biopsies to provide definitive histopathologic diagnosis . RESULTS Identafi 's white light produced lesion visibility and border distinctness equivalent to COE . Identafi 's violet light displayed a sensitivity of 12.5 % and specificity of 85.4 % for detection of oral epithelial dysplasia ( OED ) . The authors noted visible vasculature using the green-amber light in 40.9 % of lesions . CONCLUSIONS Identafi 's intraoral white light provided detailed visualization of oral mucosal lesions comparable with examination using an extraoral white-light source with magnification . A high level of clinical experience is required to interpret the results of autofluorescence examination as the violet light displayed low sensitivity for detection of OED . The green-amber light provided additional clinical information in relation to underlying vasculature and inflammation of lesions . PRACTICAL IMPLICATION S Examination using Identafi can provide clinicians with more clinical data than a st and ard COE with yellow inc and escent light , but the clinical and optical findings should be interpreted as a whole and not in isolation . Clinicians should use the light features of Identafi in a sequential and differential manner The prognosis for patients with oral squamous cell carcinoma remains poor despite advances in multimodal treatment concepts . Early diagnosis and treatment is the key to improved patient survival . A device ( VELscope ) that uses autofluorescence technology , allowing direct fluorescence visualization of the oral cavity , might be a useful tool for oral cancer detection or as an adjunct to st and ard clinical examination . A total of 289 patients with oral premalignant lesions were r and omly divided into two groups for clinical examination of precancerous oral lesions . In group 1 , 166 patients were examined conventionally with white light , and in group 2 , 123 patients were examined with the autofluorescence visualization device ( VELscope ) in addition to the white light examination . Biopsies were obtained from all suspicious areas identified in both examination groups ( n=52 ) . In the first step , baseline characteristics of the two groups ( only white light vs. white light and VELscope ) were compared to exclude selection bias . In the second step , for the group examined with white light and VELscope ( 123 patients ) , the diagnostic strategies were compared with regard to sensitivity and specificity using biopsy as the gold st and ard . The results showed that using the VELscope leads to higher sensitivity ( 100 % instead of 17 % ) , but to lower specificity ( 74 % instead of 97 % ) . Thus , we can conclude that the VELscope is a useful new diagnostic device for detection of oral cancer diseases The survival of patients with oral cancer is decreased by locoregional recurrence after an initial multimodal treatment . In order to identify lesions in the oral cavity for a possible recurrence , clinical evaluation as well as MRI or CT scanning is advised . The evaluation of mucosa lesions is hampered by changes related to radio- and chemotherapy as well as reconstruction with tissue flaps . Several techniques for easier identification of tissue abnormalities in the oral cavity have been advocated as adjuncts in order to facilitate identification . Especially methods using altered tissue fluorescence have gained much interest during the last decade . The aim of our prospect i ve study was to evaluate fluorescence properties of undiagnosed mucosa lesions with the VELscope device in patients with multimodal treated oral cancer prior to histological confirmation . In total , 41 patients with a history of oral squamous cell carcinomas ( OSCC ) ( 19 females and 22 males ) with undiagnosed mucosa lesions where included in the study . After clinical evaluation , examination and documentation using the VELscope ® device were performed . Then , an incisional biopsy was performed . An autofluorescence loss indicating a malignant or dysplastic mucosa condition could be detected in six patients ( 14.6 % ) ; however , only one OSCC and one SIN revealed a complete autofluorescence loss . In four patients , OSCC was present in lesions with retained autofluorescence . Sensitivity and specificity for the VELscope ® examination to identify malignant oral lesions by autofluorescence were 33.3 and 88.6 % , respectively . The positive and negative predictive values were 33.3 and 88.6 % , respectively . No statistical correlation between gender and lesion appearance versus autofluorescence loss could be detected . In contrast to mucosa lesions in patients with no prior treatment , the autofluorescence evaluation with the VELscope reveals no additional information in our analysis . Accordingly , invasive biopsies as gold st and ard are still needed to get sufficient evidence regarding potential malignancy in patients after multimodal treatment for oral cancer BACKGROUND An expert panel convened by the American Dental Association ( ADA ) Council on Scientific Affairs and the Center for Evidence -Based Dentistry conducted a systematic review and formulated clinical recommendations to inform primary care clinicians about the potential use of adjuncts as triage tools for the evaluation of lesions , including potentially malignant disorders ( PMDs ) , in the oral cavity . TYPES OF STUDIES REVIEW ED This is an up date of the ADA 's 2010 recommendations on the early diagnosis of PMDs and oral squamous cell carcinoma . The authors conducted a systematic search of the literature in MEDLINE and Embase via Ovid and the Cochrane Central Register of Controlled Trials to identify r and omized controlled trials and diagnostic test accuracy studies . The authors used the Grading of Recommendations Assessment , Development and Evaluation approach to assess the certainty in the evidence and to move from the evidence to the decisions . RESULTS The panel formulated 1 good practice statement and 6 clinical recommendations that concluded that no available adjuncts demonstrated sufficient diagnostic test accuracy to support their routine use as triage tools during the evaluation of lesions in the oral cavity . For patients seeking care for suspicious lesions , immediate performance of a biopsy or referral to a specialist remains the single most important recommendation for clinical practice . In exceptional cases , when patients decline a biopsy or live in rural areas with limited access to care , the panel suggested that cytologic testing may be used to initiate the diagnostic process until a biopsy can be performed ( conditional recommendation , low- quality evidence ) . CONCLUSIONS AND PRACTICAL IMPLICATION S The authors urge clinicians to remain alert and take diligent action when they identify a PMD . The authors emphasize the need for counseling because patients may delay diagnosis because of anxiety and denial OBJECTIVE AND STUDY DESIGN Several noninvasive adjunctive methods have been proposed for identification of potentially malignant mucosa lesions . The VELscope is an optical device for detecting spatial changes in mucosa autofluorescence caused by premalignant lesions in conjunction with an intraoral exam . The aim of our prospect i ve study was to correlate loss of autofluorescence from undiagnosed mucosa lesions with histology . RESULTS In total 64 patients considered at risk for squamous cell carcinoma ( 20 had previous OSCC ) were included in the study . Regions with fluorescence visualization loss were considered as malignant or dysplastic . All patients underwent biopsy after VELscope examination . In 22 patients ( 34.4 % ) a loss of autofluorescence indicating a squamous intraepithelial neoplasia ( SIN ) or malignant mucosal lesion was detected . The sensitivity of identification of malignant and dysplastic areas with the VELscope was 100 % and the specificity was 80.8 % , respectively , compared with histology as gold st and ard . The positive predictive value was 54.5 % and the negative predictive value was 100 % respectively . CONCLUSION Evaluation of autofluorescence imaging with VELscope can assist in the identification of malignant and potentially malignant oral lesions from normal mucosa in high-risk patients but does not help discriminating benign lesions from malignant or premalignant mucosal conditions BACKGROUND To analyze the efficacy of fluorescence visualization in early detection of oral early neoplastic processes when used by an inexperienced and an adept oral examiner . METHODS A dental student and an expert professional in oral diagnosis examined 15 r and omly selected patients using conventional oral examination and fluorescence visualization search ing for early signs of epithelial dysplasia and oral potentially malignant disorders . Patients detected with oral lesions in any of examinations were su bmi tted to incisional biopsy for definitive diagnosis . RESULTS Taking histopathologic analysis as Gold St and ard , sensitivity , specificity , positive and negative predictive values and accuracy of inexperienced examiner for detecting both epithelium dysplasia and oral potentially malignant disorders increased when using fluorescence visualization compared to conventional white light examination , matching the same values found for expert professional in oral diagnosis . Furthermore , it was possible to observe discrete increase in the efficacy of expert professional 's examination when using fluorescence visualization . CONCLUSION This study indicates fluorescence visualization is capable of improve inexperienced professionals ' efficacy for early detecting oral lesions more prone to be dysplastic and oral potentially malignant disorders Objective . Although approved by the US Food and Drug Administration for clinical use , the utility of h and held tissue reflectance and autofluorescence devices for screening head and neck cancer patients is poorly defined . There is limited published evidence regarding the efficacy of these devices . The authors investigated the sensitivity and specificity of these modalities compared with st and ard examination . Study Design . Prospect i ve , cross-sectional analysis . Setting . Tertiary care medical center . Subjects and Methods . Patients who were treated previously for head and neck cancer ( n = 88 ) between 2009 and 2010 were included . Patients were screened using white light visualization ( st and ard of care ) and compared with tissue reflectance and autofluorescence visualization . Screening results were compared with biopsy or long-term follow-up . Results . Autofluorescence visualization had a specificity of 81 % and a sensitivity of 50 % for detecting oral cavity cancer , whereas white light visualization had a specificity of 98 % and a sensitivity of 50 % . Tissue reflectance visualization had low sensitivity ( 0 % ) and good specificity ( 86 % ) . The power of this study was insufficient to compare the positive and negative predictive values of st and ard white light examination ( 50 % and 98 % , respectively ) to tissue autofluorescence ( 11 % and 97 % ) or reflectance ( 0 % and 95 % ) . In addition , stratification by previous radiation therapy found no statistically significant difference in screening results . Conclusion . St and ard clinical lighting has a higher specificity than tissue reflectance and autofluorescence visualization for detection of disease in patients with a history of head and neck cancer . This study does not support the added costs associated with these devices OBJECTIVE To determine the usefulness of the VELscope in detecting malignant and premalignant oral cavity lesions . STUDY DESIGN Prospect i ve clinical study . SETTING Head and neck oncology clinic at an academic tertiary care centre . SUBJECTS AND METHODS Eighty-five patients with a history of smoking , alcohol use , and /or head and neck cancer were recruited into the study . The VELscope was used to examine patients ' oral cavities after a clinical examination . Biopsies were then taken from suspicious areas . RESULTS Of the 85 patients included in the study , 33 underwent biopsies prompted by a clinical examination , the VELscope
Output:
| Optical fluorescence imaging demonstrated positive results , with higher sensitivity scores , increased lesion detection and visualisation than comprehensive oral examination alone in the clinical evaluation of oral squamous cell carcinoma and oral potentially malignant disorders . |
MS212259 | ***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: Although melatonin and cognitive-behavioural therapy have shown efficacy in treating sleep disorders in children with autism spectrum disorders , little is known about their relative or combined efficacy . One hundred and sixty children with autism spectrum disorders , aged 4 - 10 years , suffering from sleep onset insomnia and impaired sleep maintenance , were assigned r and omly to either ( 1 ) combination of controlled-release melatonin and cognitive-behavioural therapy ; ( 2 ) controlled-release melatonin ; ( 3 ) four sessions of cognitive-behavioural therapy ; or ( 4 ) placebo drug treatment condition for 12 weeks in a 1 : 1 : 1 : 1 ratio . Children were studied at baseline and after 12 weeks of treatment . Treatment response was assessed with 1-week actigraphic monitoring , sleep diary and sleep question naire . Main outcome measures , derived actigraphically , were sleep latency , total sleep time , wake after sleep onset and number of awakenings . The active treatment groups all result ed in improvements across all outcome measures , with moderate-to-large effect sizes from baseline to a 12-week assessment . Melatonin treatment was mainly effective in reducing insomnia symptoms , while cognitive-behavioural therapy had a light positive impact mainly on sleep latency , suggesting that some behavioural aspects might play a role in determining initial insomnia . The combination treatment group showed a trend to outperform other active treatment groups , with fewer dropouts and a greater proportion of treatment responders achieving clinical ly significant changes ( 63.38 % normative sleep efficiency criterion of > 85 % and 84.62 % , sleep onset latency < 30 min ) . This study demonstrates that adding behavioural intervention to melatonin treatment seems to result in a better treatment response , at least in the short term OBJECTIVE Sleep difficulties are common reasons why parents seek medical intervention in children with autism spectrum disorders ( ASDs ) . We determined whether a pamphlet alone could be used by parents to help their child ’s insomnia . METHODS Thirty-six children with ASD , ages 2 to 10 years , were enrolled . All had prolonged sleep latency confirmed by actigraphy showing a mean sleep latency of 30 minutes or more . Parents were r and omly assigned to receive the sleep education pamphlet or no intervention . Children wore an actigraphy device to record baseline sleep parameters , with the primary outcome variable being change in sleep latency . Actigraphy data were collected a second time 2 weeks after the parent received the r and omization assignment and analyzed by using Student ’s t test . Parents were also asked a series of questions to gather information about the pamphlet and its usefulness . RESULTS Although participants r and omized to the 2 arms did not differ statistically in age , gender , socioeconomic status , total Children ’s Sleep Habits Question naire score , or actigraphy parameters , some differences may be large enough to affect results . Mean change in sleep-onset latency did not differ between the r and omized groups ( pamphlet versus no pamphlet ) . Parents commented that the pamphlet contained good information , but indicated that it would have been more useful to be given specific examples of how to take the information and put it into practice . CONCLUSIONS A sleep education pamphlet did not appear to improve sleep latency in children with ASDs Objective : Sleep problems are common in children with autism spectrum disorders ( ASD ) and ADHD and impact adversely on child and parent well-being . The study evaluated the efficacy of a brief behavioral sleep intervention in children with comorbid ADHD – ASD . Method : A sub sample of children with ADHD – ASD ( n = 61 ; 5 - 13 years ; 89 % male ) participating in the Sleeping Sound With ADHD study were included in the current investigation . The sub sample comprised of 28 children r and omized to the sleep intervention group , while 33 were r and omized to usual clinical care . The intervention consisted of two clinical consultations and a follow-up phone call covering sleep hygiene and st and ardized behavioral strategies . Results : Children with ADHD – ASD who received the intervention had large improvements in sleep problems and moderate improvements in child behavioral functioning 3 and 6 months post-r and omization . Conclusion : These findings suggest that a brief behavioral sleep intervention can improve sleep problems in children with ADHD – ASD OBJECTIVES A large percentage of children with autism spectrum disorders ( ASD ) have bedtime and sleep disturbances . However , the treatment of these disturbances has been understudied . The purpose of our study was to develop a manualized behavioral parent training ( BPT ) program for parents of young children with ASD and sleep disturbances and to test the feasibility , fidelity , and initial efficacy of the treatment in a small r and omized controlled trial ( RCT ) . PARTICIPANTS AND METHODS Parents of a sample of 40 young children diagnosed with ASD with an average age of 3.5years were enrolled in our study . Participants were r and omized to either the BPT program group or a comparison group who were given nonsleep-related parent education . Each participant was individually administered a 5-session program delivered over the 8-week study . Outcome measures of feasibility , fidelity , and efficacy were collected at weeks 4 and 8 after the baseline time point . Children 's sleep was assessed by parent report and objective ly by actigraphy . RESULTS Of the 20 participants in each group , data were available for 15 participants r and omized to BPT and 18 participants r and omized to the comparison condition . Results supported the feasibility of the manualized parent training program and the comparison program . Treatment fidelity was high for both groups . The BPT program group significantly improved more than the comparison group based on the primary sleep outcome of parent report . There were no objective changes in sleep detected by actigraphy . CONCLUSIONS Our study is one of few RCTs of a BPT program to specifically target sleep disturbances in a well-characterized sample of young children with ASD and to demonstrate the feasibility of the approach . Initial efficacy favored the BPT program over the comparison group and suggested that this manualized parent training approach is worthy of further examination of the efficacy within a larger RCT
Output:
| Here we provide initial synthesis ed quantitative evidence of the effectiveness of behavioural interventions for treating sleep problems in children with ASD . |
MS212260 | ***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: BACKGROUND Recently concluded multicenter studies have shown that none of an array of echocardiographic indicators of ventricular dyssynchrony have enough sensitivity and specificity for predicting response to cardiac resynchronization therapy ( CRT ) . Inotropic contractile reserve ( ICR ) on dobutamine stress echocardiography can differentiate viable myocardium from scar and is a predictor of improvement in regional and global left ventricular function in patients with cardiomyopathy . Its role in patients undergoing CRT is unknown . The aim of this study was to evaluate the role of ICR in predicting response to CRT in patients with markedly remodeled left ventricles . METHODS Fifty-four patients ( mean age , 69±11 years ; 63 % men ) referred for clinical ly indicated CRT were evaluated . All patients underwent low-dose dobutamine stress echocardiography to assess for ICR , defined as an improvement in contractility in more than five of 16 left ventricular segments . RESULTS During a mean follow-up period of 206±167 days , 31 patients ( 57 % ) were responders , as defined by a 5-point increase in ejection fraction after CRT . The presence of ICR was a stronger predictor of response to CRT ( area under the curve , 0.94 ; χ2=39.0 ; P<.0001 ) compared with dyssynchrony ( area under the curve , 0.74 ; χ2=10.07 ; P=.002 ) . It was a significant predictor of response ( odds ratio , 2.84 ; 95 % confidence interval , 1.59 to 5.09 ; P<.0001 ) , even after controlling for the other predictors , and provided incremental prognostic value beyond that provided by QRS duration and dyssynchrony ( increase in area under the curve from 0.47 to 0.75 to 0.93 ; P=.030 and P=.008 ) . CONCLUSIONS In patients referred for CRT , ICR was a stronger predictor of response and provided incremental value beyond that of current known predictors of response to CRT ( dyssynchrony and QRS duration ) . Dobutamine stress echocardiography may have an important role in identifying CRT responders , and further multicenter studies are needed to confirm this AIMS Contradicting reports have been published regarding the relation between a dobutamine-induced increase in either cardiac dyssynchrony or left-ventricular ejection fraction ( LVEF ) and the response to cardiac resynchronization therapy ( CRT ) . Using apical rocking ( ApRock ) as surrogate dyssynchrony parameter , we investigated the dobutamine stress echocardiography (DSE)-induced changes in left-ventricular ( LV ) dyssynchrony and LVEF and their potential pathophysiological interdependence . METHODS AND RESULTS Fifty-eight guideline -selected CRT c and i date s were prospect ively enrolled for low-dose DSE . Dyssynchrony was quantified by the amplitude of ApRock . An LVEF increase during stress of > 5 % was regarded significant . Scar burden was assessed by magnetic resonance imaging . Mean follow-up after CRT implantation was 41 ± 13 months for the occurrence of cardiac death . ApRock during DSE predicted CRT response ( AUC 0.88 , 95 % CI 0.77 - 0.99 , P < 0.001 ) and correlated inversely with changes in EF ( r = -0.6 , P < 0.001 ) . Left-ventricular ejection fraction changes during DSE were not associated with CRT response ( P = 0.082 ) . Linear regression analysis revealed an inverse association of LVEF changes during DSE with both , total scar burden ( B = -2.67 , 95CI -3.77 to -1.56 , P < 0.001 ) and the DSE-induced change in ApRock amplitude ( B = -1.23 , 95 % CI -1.53 to -0.94 , P < 0.001 ) . Kaplan-Meier analysis revealed that DSE-induced increase in ApRock , but not LVEF , was associated with improved long-term survival . CONCLUSION During low-dose DSE in CRT c and i date s with baseline dyssynchrony , myocardial contractile reserve predominantly results in more dyssynchrony , but less in an increase in LVEF . Dyssynchrony at baseline and its dobutamine-induced changes are predictive of both response and long-term survival following CRT Background — Data from single-center studies suggest that echocardiographic parameters of mechanical dyssynchrony may improve patient selection for cardiac resynchronization therapy ( CRT ) . In a prospect i ve , multicenter setting , the Predictors of Response to CRT ( PROSPECT ) study tested the performance of these parameters to predict CRT response . Methods and Results — Fifty-three centers in Europe , Hong Kong , and the United States enrolled 498 patients with st and ard CRT indications ( New York Heart Association class III or IV heart failure , left ventricular ejection fraction ≤35 % , QRS ≥130 ms , stable medical regimen ) . Twelve echocardiographic parameters of dyssynchrony , based on both conventional and tissue Doppler – based methods , were evaluated after site training in acquisition methods and blinded core laboratory analysis . Indicators of positive CRT response were improved clinical composite score and ≥15 % reduction in left ventricular end-systolic volume at 6 months . Clinical composite score was improved in 69 % of 426 patients , whereas left ventricular end-systolic volume decreased ≥15 % in 56 % of 286 patients with paired data . The ability of the 12 echocardiographic parameters to predict clinical composite score response varied widely , with sensitivity ranging from 6 % to 74 % and specificity ranging from 35 % to 91 % ; for predicting left ventricular end-systolic volume response , sensitivity ranged from 9 % to 77 % and specificity from 31 % to 93 % . For all the parameters , the area under the receiver-operating characteristics curve for positive clinical or volume response to CRT was ≤0.62 . There was large variability in the analysis of the dyssynchrony parameters . Conclusion — Given the modest sensitivity and specificity in this multicenter setting despite training and central analysis , no single echocardiographic measure of dyssynchrony may be recommended to improve patient selection for CRT beyond current guidelines . Efforts aim ed at reducing variability arising from technical and interpretative factors may improve the predictive power of these echocardiographic parameters in a broad clinical setting OBJECTIVE To underst and whether patients with post-ischemic dilated cardiomyopathy and myocardial viability ( MV ) could benefit from cardiac resynchronization therapy ( CRT ) in terms of clinical , echocardiographic and neuro- hormonal parameters compared to patients without MV . METHODS One hundred and four consecutive patients were enrolled in a prospect i ve observational cohort study . Using dobutamine stress echocardiography , 2 groups were identified : group A of 51 patients with MV and group B of 53 patients without MV . All patients were implanted with biventricular pacing devices combined with an internal cardioverter-defibrillator . Clinical , echocardiographic and neuro-hormonal parameters were evaluated at baseline and at six month follow-up . Analysis of variance for repeated measures on each variable suggestive of remodeling was performed . We considered responder every patient with : decrease of > 15 % in left ventricular volumes and /or improvement in left ventricular ejection fraction of > 5 % in addition to NYHA class improvement . RESULTS All the variables improved in both groups ( time effect ) . Comparing the two groups ( group effect ) , the following variables were significantly better in group A : N-terminal pro-B-type natriuretic peptide ( p=0.02 ) , NYHA class ( p=0.003 ) , reverse remodeling ( RR ) ( p=0.007 ) , dP/dt ( p=0.005 ) , left ventricular ejection fraction ( p=0.009 ) , 3rd sound ( p=0.01 ) , and left ventricular end-systolic volume after the first week ( p=0.035 ) . RR occurred at the first week after CRT only in Group A and was maintained for all the time of this study . The maximum difference of the decrease of left ventricular volumes between the two groups occurred after the first week ( p<0.001 ) . CONCLUSION Patients with MV responded better than patients without MV with a significant improvement after the first week from CRT BACKGROUND The clinical response to biventricular pacing is unpredictable , especially in patients with ischemic cardiomyopathy . OBJECTIVES The purpose of this study was to prospect ively examine the relationship between the extent of myocardial viability and the response to cardiac resynchronization therapy . METHODS Twenty-one patients with ischemic left ventricular ( LV ) dysfunction ( left ventricular ejection fraction [ LVEF ] 21 + /- 5 % ) , New York Heart Association ( NYHA ) functional class III-IV , and QRS > 120 ms received biventricular devices . Myocardial viability was assessed by myocardial contrast echocardiography , and a perfusion score index ( PSI ) was calculated from summed segmental perfusion scores . LV performance was assessed by echocardiography on the day after implantation and at 6 months . RESULTS PSI was closely correlated with acute improvement in LVEF ( P = .003 , r = 0.65 ) , stroke volume ( P = .02 , r = 0.54 ) , and end-systolic volume ( P = .05 , r = -0.49 ) . PSI also correlated with early diastolic LV relaxation ( E ' , P < .05 , r = 0.50 ) and global myocardial performance or Tei index ( P = .003 , r = 0.63 ) . By multiple linear regression analysis , PSI provided incremental predictive value to the degree of dyssynchrony , measured by tissue Doppler imaging , for predicting improvement in LVEF . At 6 months , PSI remained positively correlated with improvement in ventricular performance and with reduction in LV end-diastolic dimension ( P = .003 , r = -0.68 ) . PSI also influenced the clinical variables of NYHA class , 6-minute walk distance , quality -of-life score , and number of hospitalizations for heart failure . CONCLUSION In patients with ischemic cardiomyopathy , the extent of myocardial viability predicts acute and long-term improvement in LV performance , exercise tolerance , and reduction in LV end-diastolic dimension with biventricular pacing A substantial proportion of patients who meet the current guidelines for cardiac resynchronization therapy ( CRT ) fail to respond to this pacing modality . Although appropriate patient selection and left ventricular ( LV ) lead location have been ascribed as determinants of CRT response , the interaction among contractile reserve , dynamics of dyssynchrony , and lead location is not well understood . The present study prospect ively evaluated the effect of contractile reserve and dobutamine-induced changes in LV synchrony , in relation to the LV lead location , as predictors of the response to CRT . In the present study , 31 patients were prospect ively evaluated and underwent low-dose dobutamine echocardiography . The dobutamine-induced increase in ejection fraction ( contractile reserve [ CR ] ) was measured , and the most mechanically delayed segment was identified to classify patients into 2 groups . Group 1 had a CR of > 20 % and a LV lead position concordant with the mechanically delayed segment . Group 2 included the remaining patients ( i.e. , low CR , discordant LV lead position , or both ) . Patients in group 1 were significantly more likely to have an echocardiographic response at 6 months ( 80 % of group 1 vs 29 % of group 2 , p = 0.018 ) and had an improved 2-year heart failure hospitalization-free survival rate ( 90 % in group 1 vs 33 % in group 2 , p = 0.006 ) . In conclusion , low-dose dobutamine echocardiography provides information that can help to predict responders to CRT . The response rates and heart failure hospitalization-free survival were improved in those patients with a CR > 20 % and an LV lead tip concordant with the most delayed mechanical segment BACKGROUND Cardiac resynchronization therapy ( CRT ) is effective in selected patients with heart failure ( HF ) . Nevertheless , the nonresponder rate remains high . The low-dose dobutamine stress-echo ( DSE ) test detects the presence of left ventricular ( LV ) contractile reserve ( LVCR ) in HF patients of any etiology and may be useful in predicting response to resynchronization . OBJECTIVE The purpose of this study was to present the results of the LODO-CRT trial , which evaluated whether LVCR presence at baseline increases the chances of response to CRT . METHODS LODO-CRT is a multicenter prospect i ve study that enrolled CRT c and i date s according to guidelines . LVCR presence was defined as an LV ejection fraction increase > 5 units during DSE test . CRT response is assessed at 6-month follow-up as an LV end-systolic volume reduction ≥10 % . RESULTS Two hundred seventy-one patients were enrolled . The DSE test was feasible without complications in 99 % of patients . Nine patients died from noncardiac disease , and 31 presented inadequate data . Two hundred thirty-one patients were included in the analysis . Mean patient age was 67 ± 10 years ; 95 % were in New York Heart Association class III , and 42 % had HF of
Output:
| The presence of global contractile reserve at baseline , as assessed by dobutamine stress echocardiography , is associated with a higher chance of CRT response in patients with heart failure |
MS212261 | ***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: Pediatric patients who undergo posterior spinal fusion surgery to correct scoliosis often require multiple blood transfusions . Tranexamic acid is a synthetic antifibrinolytic drug that reduces transfusion requirements in cardiac surgery and total knee arthroplasty . We evaluated the efficacy of prophylactic tranexamic acid to reduce perioperative blood transfusion requirements in a prospect i ve , double-blinded , placebo control study . Forty patients , 9–18 yr of age , were r and omized to either tranexamic acid ( initial dose of 10 mg/kg and infusion of 1 mg · kg−1 · h−1 ) or placebo ( isotonic saline ) . Perioperative management was st and ardized . A uniform transfusion threshold for noncell saved red blood cells was 7.0 g/dL. The total amount of blood transfused in the perioperative period was significantly reduced in the Tranexamic group ( P = 0.045 ) . No thrombotic complications were detected in either group . The administration of prophylactic tranexamic acid in patients with scoliosis undergoing posterior spinal fusion surgery has the potential to reduce perioperative blood transfusion requirements Background : Previous studies have noted that the use of antifibrinolytic medications can help reduce blood loss and transfusion requirements during cardiac , total joint arthroplasty , and spine surgery . Tranexamic acid ( TXA ) has been investigated in these patient groups but consensus with respect to the dosing regimen has not been achieved , especially in the pediatric scoliosis literature . The purpose of this study was to compare the effects of 2 TXA dosing regimens on reducing transfusion requirements . Methods : A retrospective chart review was performed on all idiopathic scoliosis patients undergoing posterior spinal instrumentation and fusion from 2005 to 2006 to determine total perioperative transfusion requirements . Transfusion requirements for those patients receiving either a low ( 10 mg/kg loading , 1 mg/kg/h infusion ) or high ( 20 mg/kg loading , 10 mg/kg/h infusion ) dose of TXA were compared . Results : High-dose TXA ( n = 11 ) showed a trend toward a reduction in transfusion requirements compared with the low dose ( n = 15 ) for idiopathic scoliosis patients undergoing posterior only instrumentation and fusion ( 687.9 ± 778.1 mL vs 1372.6 ± 1077.3 mL ; P = 0.07 ; 95 % confidence interval for the mean difference , −66.3 mL to 1435.7 mL ) . Although substantial , this difference was underpowered to show a difference . Conclusions : The use of the higher dose of TXA result ed in a 50 % reduction in transfusion requirements for idiopathic scoliosis patients . Given previous studies , there appears to be a dose-response effect . A prospect i ve dose-ranging study is now required to determine the optimal dose for pediatric patients with idiopathic scoliosis . Level of Evidence : III , retrospective cohort study Background : Excessive bleeding often occurs during pediatric scoliosis surgery and is attributed to numerous factors , including accelerated fibrinolysis . The authors hypothesized that administration of tranexamic acid would reduce bleeding and transfusion requirements during scoliosis surgery . Methods : Forty-four patients scheduled to undergo elective spinal fusion were r and omly assigned to receive either 100 mg/kg tranexamic acid before incision followed by an infusion of 10 mg · kg−1 · h−1 during surgery ( tranexamic acid group ) or 0.9 % saline ( placebo group ) . General anesthesia was administered according to a st and ard protocol . Blood loss , transfusion requirements , coagulation parameters , and complications were assessed . Results : In the tranexamic acid group , blood loss was reduced by 41 % compared with placebo ( 1,230 ± 535 vs. 2,085 ± 1,188 ml ; P < 0.01 ) . The amount of blood transfused did not differ between groups ( 615 ± 460 vs. 940 ± 718 ml ; P = 0.08 ) . Administration of tranexamic acid was a multivariate predictor of blood loss , as was American Society of Anesthesiologists physical status and preoperative platelet count . No apparent adverse drug effects occurred in any patient . Conclusion : Intraoperative administration of tranexamic acid significantly reduces blood loss during spinal surgery in children with scoliosis BACKGROUND Aprotinin and epsilon aminocaproic acid are antifibrinolytic agents used to reduce postoperative blood loss after cardiopulmonary bypass . We compared low dose aprotinin with epsilon aminocaproic acid and a combination of the two agents to reduce postoperative blood loss in infants with congenital cyanotic heart disease undergoing corrective surgical procedures . METHODS This prospect i ve study was conducted r and omly on 300 children . Group I ( n = 80 ) acted as the control and did not receive either of the study drugs . Group II ( n = 100 ) received low dose aprotinin , group III ( n = 60 ) received epsilon aminocaproic acid , and group IV ( n = 60 ) received a combination of the two antifibrinolytic agents . RESULTS The control group had the longest time for sternal closure , maximum blood loss at 24 hours , and greatest requirements for packed red blood cells and platelets . Fibrinogen levels were significantly lower , and levels of fibrin breakdown products were significantly higher compared with the groups given either or both of the antifibrinolytics . CONCLUSIONS Epsilon aminocaproic acid is as efficacious as low dose aprotinin in reducing postoperative blood loss and packed red blood cell and platelet requirements in children with congenital cyanotic heart disease . The combination of the two was slightly more effective UNLABELLED In this prospect i ve cohort study of 548 children undergoing open-heart surgery , we evaluated demographic and perioperative factors to identify variables associated with perioperative blood loss and blood product transfusions . Using multivariate analysis , younger patient age was found to be the variable most significantly associated with bleeding and transfusions . Higher preoperative hematocrit , complex surgery , lower platelet count during cardiopulmonary bypass ( CPB ) , and longer duration of deep hypothermic circulatory arrest were also significantly associated with bleeding and transfusion . Excessive postoperative chest tube ( CT ) drainage was associated with intraoperative bleeding . Independently associated variables accounted for 76 % of the variability in CT output measured after 2 h in intensive care . Patients were subdivided into children aged < or = 1 yr ( infants ) and children > 1 yr ; infants bled more intraoperatively ( P<0.005 ) ; had greater cumulative CT output at 2 , 6 , 12 , and 24 h ( P<0.0001 ) ; and received more blood products ( P<0.0001 ) . Factors associated with bleeding and transfusions varied with patient age . Lower body core temperature during CPB was highly associated with blood loss and transfusions in infants , whereas resternotomy , preoperative congestive heart failure , and prolonged duration of CPB were significant factors associated with bleeding and transfusions in children > 1 yr old . IMPLICATION S Knowledge of the factors associated with blood loss and blood product transfusions can help to identify children at risk of excessive bleeding after open-heart surgery Background : Surgical correction of craniosynostosis in children is associated with substantial intraoperative bleeding . Tranexamic acid ( TXA ) decreases intraoperative blood loss during cardiac or orthopedic surgery in children . We hypothesized that intraoperative TXA would reduce blood transfusion relative to placebo in patients pretreated with erythropoietin . Methods : Forty consecutive children , American Society of Anesthesiologists status 1 or 2 , scheduled to undergo surgical correction of craniosynostosis were r and omly assigned to receive either intravenous TXA or saline , 0.9 % , intraoperatively . All children received preoperative erythropoietin ( 600 U/kg once a week for 3 weeks before surgery ) . Perioperative blood loss , number and volume of transfusions , percentage of children who underwent transfusion , and side effects were noted after surgery and at the end of the study . Surgeon satisfaction and cost of treatment were also recorded . Results : There was no significant difference between groups in demographic or surgical data . In the TXA group , the volume of packed erythrocytes transfused was significantly reduced by 85 % ( from 11 to 1.6 ml/kg ) intraoperatively and by 57 % ( from 16.6 to 7.2 ml/kg ) throughout the study period ( P < 0.05 ) . Compared with the placebo group , the percentage of children requiring blood transfusion was lower in the TXA group during surgery ( 9 [ 45 % ] of 20 vs. 2 [ 11 % ] of 19 children ; P < 0.05 ) and during the whole study period ( 14 [ 70 % ] of 20 vs. 7 [ 37 % ] of 19 ; P < 0.05 ) . Preoperative and postoperative hematologic parameters were comparable in both groups . There were no adverse events . Conclusion : In children undergoing surgical correction of craniosynostosis and pretreated with erythropoietin , intraoperative TXA reduces the transfusion requirement Study Design . A retrospective study of the effectiveness of Amicar ( epsilon aminocaproic acid ) . Objective . Evaluate the effectiveness of Amicar in decreasing perioperative blood loss and transfusion requirements in same-day anterior ( ASF ) and posterior spinal fusion ( PSF ) with segmental spinal instrumentation ( SSI ) for idiopathic scoliosis . Summary of Background Data . Preliminary prospect i ve , prospect i ve r and omized double-blind , and fibrinogen studies have demonstrated Amicar to be effective in decreasing perioperative blood loss in patients with idiopathic scoliosis undergoing PSF with SSI . Increased fibrinogen secretion is a possible explanation . Methods . There were 73 consecutive patients divided into 3 study groups based on the administration of Amicar : Group 1 ( n = 16 ) , no Amicar ; Group 2 ( n = 18 ) , Amicar for the PSF with SSI only ; and Group 3 ( n = 39 ) , Amicar for both ASF and PSF with SSI . All patients were managed using the same general anesthesia technique , intraoperative procedure , postoperative care path , and indications for transfusion ( hemoglobin < 7g/dL ) . Total perioperative blood loss ( estimated intraoperative blood loss for both procedures and measured postoperative chest tube and PSF wound suction drainage ) and total transfusion requirements between groups were compared using one-way ANOVA . Results . There were statistically significant decreases in mean estimated intraoperative PSF with SSI , total perioperative blood loss , and transfusion requirements in the 2 Amicar groups . However , Amicar had no significant effect on estimated intraoperative ASF blood loss , chest tube drainage , or PSF wound suction drainage . Total perioperative blood loss and transfusion requirements ( cell saver , autologous , directed , and allogeneic blood ) were : 3442.8 ± 1344.0 mL and 1537.1 ± 905.1 mL in Group 1 ; 2089.8 ± 684.0 mL and 485.2 ± 349.8 mL in Group 2 ; and 2184.1 ± 1163.7 mL and 531.5 ± 510.5 mL in Group 3 . There were no Amicar related complications . Conclusion . Amicar was highly effective in decreasing total perioperative blood loss and transfusion requirements in same-day ASF and PSF with SSI for idiopathic scoliosis . It results in less preoperative autologous blood donation , perioperative blood transfusion , costs , and potential transfusion-related complications . It was mosteffective in decreasing intraoperative estimated PSF with SSI blood loss . It had no significant effect during the ASF , postoperative chest tube , or PSF wound suction drainage . We now recommend that it be used for the PSF with SSI procedure only We performed a prospect i ve , r and omized , placebo-controlled , double-blind trial to assess the efficacy of aprotinin in 61 children ( median age 3.7 yr ) undergoing reoperative open heart surgery ( OHS ) . Three demographically similar groups were studied : large-dose aprotinin ( ALD ) , small-dose aprotinin ( ASD ) , and placebo ( P ) . Over the first 24 postoperative hours fewer patients in the aprotinin groups received packed red cells ( ALD , 53 % ; ASD , 89 % ; and P , 95 % ; P = 0.001 ) , platelets ( ALD , 32 % ; ASD , 50 % ; and P , 65 % ; P = 0.04 ) , and fresh frozen plasma ( ALD , 16 % ; ASD , 17 % ; and P , 60 % ; P = 0.003 ) than placebo patients . Most importantly , aprotinin patients had fewer exposures to banked blood components ( ALD , median 1 U ; and ASD , median 2 U ) than P ( median 6 U ; P
Output:
| Antifibrinolytics are effective in reducing blood loss and transfusion requirements in major pediatric surgery .
TXA and EACA also appear to have reasonable side-effect profiles . |
MS212262 | ***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 A r and omised trial was performed on patients presenting to hospital with an exacerbation of chronic obstructive pulmonary disease ( COPD ) to compare outcomes in those managed at home with support with those admitted to hospital in the st and ard manner . METHODS Over an 18 month period all patients presenting to the Royal Infirmary of Edinburgh on weekdays ( n=718 ) with a diagnosis of an exacerbation of COPD were assessed for inclusion in the trial . Patients with impaired level of consciousness , acute confusion , acute changes on radiography , or an arterial pH of < 7.35 or with other serious medical or social reasons for admission were excluded . Patients r and omised to home support were discharged with an appropriate treatment package ( antibiotics , corticosteroids , nebulised bronchodilators and , if necessary , home oxygen ) . They were visited by a nurse the following day and thereafter at intervals of 2 - 3 days until recovery when they were discharged from follow up . Parallel observations were made on patients allocated to normal hospital admission up to the point of discharge . Patients in both groups were assessed at home eight weeks after the initial assessment . RESULTS Among weekday patients 353 ( 50 % ) were considered obligatory admissions , 140 ( 19 % ) were admitted because of co-morbidity , 17 ( 2 % ) because of poor social circumstances , and 24 ( 3 % ) did not consent to the trial . The remaining 184 ( 26 % ) were r and omised ( 2:1 ) either to home support or to a st and ard hospital admission . The median time to discharge was 7 days for the home support group and 5 days for the admitted group ( p<0.01 ) ; 25 % of the home support group and 34 % of the admitted group were readmitted before the final assessment at eight weeks ( p>0.05 ) . There were no significant differences between the groups in attendances by GPs and carers or in health status measured eight weeks after the initial assessment . Satisfaction with the service was good . The mean total health service cost per patient was estimated as 877 pounds sterling for the home support group and 1753 pounds sterling for the admitted group . CONCLUSIONS This study shows that home supported discharge is a well tolerated , safe , and economic alternative to hospital admission for a proportion of patients referred to hospital for admission for an exacerbation of COPD The aim of the present prospect i ve multicentric study was to develop a simple rule for the prediction of poor outcome in patients presenting to emergency departments with initially non-life threatening-chronic obstructive pulmonary disease ( COPD ) exacerbations in a real-life setting . All patients with an acute exacerbation of COPD visiting the emergency departments of 103 hospitals during a 3-month period were included , except those who immediately required intensive care unit admission and /or ventilatory support . The data collected included patient characteristics , in-hospital outcomes ( mortality and length of stay ) and mode of discharge ( unsupported or need for post-hospital assistance ) . The in-hospital mortality rate was 7.4 % ( 59 out of 794 ) . Independent prognostic factors were age , number of clinical signs of severity ( among cyanosis , impaired neurological status , lower limb oedema , asterixis and use of accessory inspiratory or expiratory muscles ) and dyspnoea grade in the stable state . The need for post-hospital support was also predicted by female sex . In order to construct and vali date a prediction score for mortality based on these items , patients were r and omly allocated to a derivation and a validation cohort . The prediction score showed good discrimination , with a c-statistic of 0.79 in the derivation cohort and 0.83 in the validation cohort . Thus simple purely clinical factors can reliably predict the risk of death and requirement for post-hospital support in an initially non-life threatening-acute exacerbation of chronic obstructive pulmonary disease . Their use needs to be prospect ively vali date Background Exacerbations of Chronic Obstructive Pulmonary Disease ( COPD ) are the main cause for hospitalisation . These hospitalisations result in a high pressure on hospital beds and high health care costs . Because of the increasing prevalence of COPD this will only become worse . Hospital at home is one of the alternatives that has been proved to be a safe alternative for hospitalisation in COPD . Most schemes are early assisted discharge schemes with specialised respiratory nurses providing care at home . Whether this type of service is cost-effective depends on the setting in which it is delivered and the way in which it is organised . Methods / Design GO AHEAD ( Assessment Of Going Home under Early Assisted Discharge ) is a 3-months , r and omised controlled , multi-centre clinical trial . Patients admitted to hospital for a COPD exacerbation are either discharged on the fourth day of admission and further treated at home , or receive usual inpatient hospital care . Home treatment is supervised by general nurses . Primary outcome is the effectiveness and cost effectiveness of an early assisted discharge intervention in comparison with usual inpatient hospital care for patients hospitalised with a COPD exacerbation . Secondary outcomes include effects on quality of life , primary informal caregiver burden and patient and primary caregiver satisfaction . Additionally , a discrete choice experiment is performed to provide insight in patient and informal caregiver preferences for different treatment characteristics . Measurements are performed on the first day of admission and 3 days , 7 days , 1 month and 3 months thereafter . Ethical approval has been obtained and the study has been registered . Discussion This article describes the study protocol of the GO AHEAD study . Early assisted discharge could be an effective and cost-effective method to reduce length of hospital stay in the Netherl and s which is beneficial for patients and society . If effectiveness and cost-effectiveness can be proven , implementation in the Dutch health care system should be considered . Trial registration Netherl and s Trial Register NTR1129 BACKGROUND We have previously reported the use of a hospital based respiratory nurse service ( Acute Respiratory Assessment Service , ARAS ) to support home treatment of patients with exacerbations of chronic obstructive pulmonary disease ( COPD ) . A controlled trial was undertaken to compare early discharge with home treatment supported by respiratory nurses with conventional hospital management of patients admitted with exacerbations of COPD . METHODS Patients with COPD admitted as emergencies were identified the next working day . They were eligible for inclusion in the study if the differential diagnosis included an exacerbation of COPD , but were excluded if other medical conditions or acidotic respiratory failure required inpatient investigation or management . Of 360 patients review ed , 209 were being assessed for other active medical problems and were excluded , 33 potential participants were already involved in research studies and so were ineligible , and 37 did not wish to participate in the study . Eighty one patients were r and omised to receive conventional inpatient care ( n=40 ) or to planned early discharge the next working day ( n=41 ) . Those discharged early continued treatment at home under the supervision of specialist respiratory nurses . Outcome measures were readmission , additional hospital days , and deaths within 60 days of initial admission . Process measures included number of visits , duration of follow up by the respiratory nurse , and additional treatment provided to support early discharge . RESULTS On an intention to treat basis , a policy of early discharge reduced inpatient stay from a mean of 6.1 ( range 1–13 ) days with conventional management to 3.2 ( 1–16 ) days with an early discharge policy . Twelve patients ( 30 % conventional management , 29.3 % early discharge ) were readmitted in each group giving a mean difference in readmission of 0.7 % ( 95 % CI of the difference –19.2 to 20.6 ) . In the conventional management group readmitted patients spent a mean of 8.75 additional days in hospital compared with 7.83 days in the early discharge group , giving a mean difference of 0.92 days ( 95 % CI of the difference –6.5 to 8.3 ) . There were two deaths ( 5 % ) in the conventional management group and one ( 2.4 % ) in the early discharge group , a mean difference of 2.6 % ( 95 % CI of the difference –5.7 to 10.8 ) . CONCLUSIONS Patients with acute exacerbations of COPD uncomplicated by acidotic respiratory failure or other medical problems can be discharged home earlier than is current practice with support by visiting respiratory nurses . No difference was found in the subsequent need for readmission It was postulated that home hospitalisation ( HH ) of selected chronic obstructive pulmonary disease ( COPD ) exacerbations admitted at the emergency room ( ER ) could facilitate a better outcome than conventional hospitalisation . To this end , 222 COPD patients ( 3.2 % female ; 71±10 yrs ( mean±sd ) ) were r and omly assigned to HH ( n=121 ) or conventional care ( n=101 ) . During HH , integrated care was delivered by a specialised nurse with the patient 's free-phone access to the nurse ensured for an 8‐week follow-up period . Mortality ( HH : 4.1 % ; controls : 6.9 % ) and hospital readmissions ( HH : 0.24±0.57 ; controls : 0.38±0.70 ) were similar in both groups . However , at the end of the follow-up period , HH patients showed : 1 ) a lower rate of ER visits ( 0.13±0.43 versus 0.31±0.62 ) ; and 2 ) a noticeable improvement of quality of life ( Δ St George 's Respiratory Question naire ( SGRQ ) , −6.9 versus −2.4 ) . Furthermore , a higher percentage of patients had a better knowledge of the disease ( 58 % versus 27 % ) , a better self-management of their condition ( 81 % versus 48 % ) , and the patient 's satisfaction was greater . The average overall direct cost per HH patient was 62 % of the costs of conventional care , essentially due to fewer days of inpatient hospitalisation ( 1.7±2.3 versus 4.2±4.1 days ) . A comprehensive home care intervention in selected chronic obstructive pulmonary disease exacerbations appears as cost effective . The home hospitalisation intervention generates better outcomes at lower costs than conventional care Objectives To determine the effectiveness of early assisted discharge for chronic obstructive pulmonary disease ( COPD ) exacerbations , with home care provided by generic community nurses , compared with usual hospital care . Design Prospect i ve , r and omised controlled and multicentre trial with 3-month follow-up . Setting Five hospitals and three home care organisations in the Netherl and s. Participants Patients admitted to the hospital with an exacerbation of COPD . Patients with no or limited improvement of respiratory symptoms and patients with severe unstable comorbidities , social problems or those unable to visit the toilet independently were excluded . Intervention Early discharge from hospital after 3 days inpatient treatment . Home visits by generic community nurses . Primary outcome measure was change in health status measured by the Clinical COPD Question naire ( CCQ ) . Treatment failures , readmissions , mortality and change in generic health-related quality of life ( HRQL ) were secondary outcome measures . Results 139 patients were r and omised . No difference between groups was found in change in CCQ score at day 7 ( difference in mean change 0.29 ( 95 % CI −0.03 to 0.61 ) ) or at 3 months ( difference in mean change 0.04 ( 95 % CI –0.40 to 0.49 ) ) . No difference was found in secondary outcomes . At day 7 there was a significant difference in change in generic HRQL , favouring usual hospital care . Conclusions While patients ’ disease-specific health status after 7-day treatment tended to be somewhat better in the usual hospital care group , the difference was small and not clinical ly relevant or statistically significant . After 3 months , the difference had disappeared . A significant difference in generic HRQL at the end of the treatment had disappeared after 3 months and there was no difference in treatment failures , readmissions or mortality . Early assisted discharge with community nursing is feasible and an alternative to usual hospital care for selected patients with an acute COPD exacerbation . Trial registration : Netherl and sTrialRegister NTR 1129 BACKGROUND The study was conducted to investigate the safety of " hospital at home " versus hospital care . MATERIAL S AND METHODS It was a prospect i ve r and omised controlled trial . Patients with an exacerbation of chronic obstructive pulmonary disease ( COPD ) were included and r and omised to supported discharge ( n = 22 ) or to conventional in-patient care ( n = 22 ) . Outcome measures were readmissions , complications , mortality within 60 days of initial admission . RESULTS 390 patients ( COPD ) were admitted and 44 patients ( 12 % ) were included in the study . In the home treatment period 2 patients ( 9 % ) were readmitted . One patient ( 4.5 % ) died 2 weeks after discharge from the home treatment . In the follow-up period 3 patients in the home treated group were readmitted 7 times ( 31.8 % ) , and 7 patients in the conventional in-patient group were readmitted 9 times ( 40.9 % ) . There were 14 complications ( 63.6 % ) in the home treated group and 15 complications ( 68.3 % ) in the conventional in-patient group . The length of hospital stays in the supported discharged group were shorter ( 1.3 ( std = 0.5 ) versus 3.7 ( std = 2.8 ) days , p = 0.002 ) . After discharge a respiratory nurse visited supported discharged patients at home during 5.1 days ( min
Output:
| Costs were lower for ESD/HAH than UC .
ESD/HAH is safe in selected patients with an AE COPD . |
MS212263 | ***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 Subjects with a mild cognitive impairment ( MCI ) have a memory impairment beyond that expected for age and education yet are not demented . These subjects are becoming the focus of many prediction studies and early intervention trials . OBJECTIVE To characterize clinical ly subjects with MCI cross-sectionally and longitudinally . DESIGN A prospect i ve , longitudinal inception cohort . SETTING General community clinic . PARTICIPANTS A sample of 76 consecutively evaluated subjects with MCI were compared with 234 healthy control subjects and 106 patients with mild Alzheimer disease ( AD ) , all from a community setting as part of the Mayo Clinic Alzheimer 's Disease Center/Alzheimer 's Disease Patient Registry , Rochester , Minn. MAIN OUTCOME MEASURES The 3 groups of individuals were compared on demographic factors and measures of cognitive function including the Mini-Mental State Examination , Wechsler Adult Intelligence Scale-Revised , Wechsler Memory Scale-Revised , Dementia Rating Scale , Free and Cued Selective Reminding Test , and Auditory Verbal Learning Test . Clinical classifications of dementia and AD were determined according to the Diagnostic and Statistical Manual of Mental Disorders , Revised Third Edition and the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer 's Disease and Related Disorders Association criteria , respectively . RESULTS The primary distinction between control subjects and subjects with MCI was in the area of memory , while other cognitive functions were comparable . However , when the subjects with MCI were compared with the patients with very mild AD , memory performance was similar , but patients with AD were more impaired in other cognitive domains as well . Longitudinal performance demonstrated that the subjects with MCI declined at a rate greater than that of the controls but less rapidly than the patients with mild AD . CONCLUSIONS Patients who meet the criteria for MCI can be differentiated from healthy control subjects and those with very mild AD . They appear to constitute a clinical entity that can be characterized for treatment interventions Intima-media thickness ( IMT ) is increasingly used as a surrogate end point of vascular outcomes in clinical trials aim ed at determining the success of interventions that lower risk factors for atherosclerosis and associated diseases ( stroke , myocardial infa rct ion and peripheral artery diseases ) . The necessity to promote further criteria to distinguish early atherosclerotic plaque formation from thickening of IMT and to st and ardize IMT measurements is expressed through this up date d consensus . Plaque is defined as a focal structure that encroaches into the arterial lumen of at least 0.5 mm or 50 % of the surrounding IMT value or demonstrates a thickness > 1.5 mm as measured from the media-adventitia interface to the intima-lumen interface . St and ard use of IMT measurements is based on physics , technical and disease-related principles as well as agreements on how to perform , interpret and document study results . Harmonization of carotid image acquisition and analysis is needed for the comparison of the IMT results obtained from epidemiological and interventional studies around the world . The consensus concludes that there is no need to ‘ treat IMT values ’ nor to monitor IMT values in individual patients apart from exceptions named , which emphasize that inside r and omized clinical trials should be performed . Although IMT has been suggested to represent an important risk marker , according to the current evidence it does not fulfill the characteristics of an accepted risk factor . St and ardized methods recommended in this consensus statement will foster homogenous data collection and analysis . This will help to improve the power of r and omized clinical trials incorporating IMT measurements and to facilitate the merging of large data bases for meta-analyses A , Delecluse C et al. Habitual level of physical activity and muscle fatigue of the elbow flexor muscles in older men . L et al. Lower extremity performance is associated with daily life physical activity in individuals with and without peripheral arterial disease . Muscle strength in the triceps surae and objective ly measured customary walking activity in men and women over 65 years of age . A short physical performance battery assessing lower extremity function : association with self-reported disability and prediction of mortality and nursing home admission . The association between physical function and lifestyle activity and exercise in the health , aging and body composition study . Effect of exercise on ease in performing activities of daily living and instrumental activities of daily living from age 70 to 77 : the Jerusalem longitudinal study . Rennie KL et al. Validity and repeatability of a simple index derived from the short physical activity question naire used in the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) study . SIR — The Folstein Mini-Mental State Examination ( MMSE ) , developed in 1975 as a bedside test of cognitive function , has been extensively used in clinical practice and research and is widely accepted as a clinical tool for diagnosing and monitoring dementia [ 1 ] . Despite its low sensitivity and specificity ( 0.56 and 0.73 , respectively , in one recent study ) [ 2 ] , comparable tools , including the Modified MMSE of Teng and Chui [ 3 ] have not received such widespread acceptance . It contains 11 questions that test orientation , registration , attention , calculation , recall , language and visuospatial functioning , with a maximum score of 30 . It takes minutes to administer and is practical for routine clinical use . Most questions are administered verbally . Hearing loss reduces performance on the verbal parts of the examination even in cognitively intact patients , with potential diagnostic error and alteration of management [ 4 ] . This is of concern , as hearing impairment affects over one-fourth of people over 65 years of age , and half of those over 75 years in most industrialised nations [ 5 ] . Uhlmann [ 6 ] tested 71 Alzheimer 's disease subjects with varying levels of hearing , using both written and st and ard versions of the MMSE . Paradoxically , they found that hearing-impaired subjects scored higher in the st and ard than the written version , while subjects with normal hearing performed better using the written version , although these findings were not statistically significant . We ( M.M. ) developed a written version of the MMSE , found it clinical ly useful , and report here an evaluation of its performance in a hospital-based population Background : The cognitive continuum in the elderly population can be conceptually divided into those who are functioning normally ( control subjects ) , those with a mild cognitive impairment ( MCI ) , and those with probable AD . Objectives : To test the hypothesis that the annualized rates of hippocampal atrophy differ as a function of both baseline and change in clinical group membership ( control , MCI , or AD ) . Methods : The authors identified 129 subjects from the Mayo Clinic AD Research Center/AD Patient Registry who met established criteria for normal control subjects , MCI , or probable AD , both at entry and at the time of a subsequent clinical follow-up evaluation 3 ± 1 years later . Each subject underwent an MRI examination of the head at the time of the initial assessment and at follow-up clinical assessment ; the annualized percentage change in hippocampal volume was computed . Subjects who were classified as controls or patients with MCI at baseline could either remain cognitively stable or could decline to a lower functioning group over the period of observation . Results : The annualized rates of hippocampal volume loss for each of the three initial clinical groups decreased progressively in the following order : AD > MC > control . Within the control and MCI groups , those who declined had a significantly greater rate of volume loss than those who remained clinical ly stable . The mean annualized rates of hippocampal atrophy by follow-up clinical group were : control-stable 1.73 % , control-decliner 2.81 % , MCI-stable 2.55 % , MCI-decliner 3.69 % , AD 3.5 % . Conclusion : Rates of hippocampal atrophy match both baseline cognitive status and the change in cognitive status over time in elderly persons who lie along the cognitive continuum from normal to MCI to AD Cerebral white matter lesions ( WML ) seen on magnetic resonance imaging scans are associated with cardiovascular disease and vascular risk factors . To assess the association between WML and atherosclerosis , we studied 111 people , aged 65 to 85 years , r and omly sample d , and stratified by age and sex , from participants in the Rotterdam Study . Cerebral T2-weighted magnetic resonance images in the axial plane were obtained for all subjects . Carotid atherosclerosis was ultrasonographically assessed by the presence of stenosis , measurement of intima to media wall thickness ( IMT ) , and the presence of atherosclerotic plaques . A possible or definite myocardial infa rct ion on an electrocardiogram was used as an indicator of coronary atherosclerosis . The ankle to arm systolic blood pressure ratio ( ABI ) was determined , and peripheral arterial disease was defined as an ABI lower than 0.90 in at least one side . Carotid atherosclerosis was significantly more pronounced in people with WML . The difference in common carotid IMT was 0.13 mm ( 95 % confidence interval [ CI ] 0.04 - 0.21 ) , whereas the odds ratio of WML associated with plaques in the carotid bifurcation was 3.9 . The degree of internal carotid artery stenosis was not , however , associated with WML . The mean ABI was significantly lower in people with WML than in those without lesions with a difference of -0.11 ( 95 % CI -0.21 to -0.01 ) . The odds ratio of WML associated with peripheral arterial disease and a possible or definite myocardial infa rct ion was 2.4 and 3.1 , respectively . We conclude that atherosclerosis , indicated by increased common carotid IMT , carotid plaques , and a lower ABI , is related to WML To evaluate the association between common carotid intima-media thickness and noninvasively assessed atherosclerosis elsewhere in the carotid artery , we used data from the Rotterdam Study , a single-center population -based , prospect i ve follow-up study among 7983 subjects aged 55 years or older . Baseline measurements included ultrasonographic evaluation of the vessel wall characteristics of the carotid arteries , that is , assessment of the presence of atherosclerotic lesions , measurement of common carotid intima-media thickness , and determination of the presence of hemodynamically significant stenosis . The present analysis is based on data obtained from the first 1000 participants . The results were adjusted for age and gender . An increase of 1 st and ard deviation in common carotid intima-media thickness ( 0.19 mm ) doubled the risk of plaques in the carotid bifurcation : odds ratio 2.0 ( 95 % confidence interval ( CI ) : 1.6 , 2.4 ) . For hemodynamically significant stenosis of the right internal carotid artery ( > or = 50 % ) , a 1.4 ( 95 % CI : 1.0 , 2.0 ) increased risk was found . The risk of atherosclerotic plaques in the bifurcation in subjects with an intima-media thickness above 0.89 mm ( upper quintile ) relative to those with an intima-media thickness below 0.63 mm ( lowest quintile ) was 6.0 ( 95 % CI : 3.5 , 10.2 ) . For internal carotid artery stenosis , a relative risk of 2.8 ( 95 % CI 0.5 , 15.7 ) was found . The findings of the present study provide evidence that increased common carotid intima-media thickness indicates atherosclerosis at other sites of the carotid artery . This study lends support to the view that noninvasively assessed increased intima-media thickness of the distal common carotid artery is an indicator of generalized atherosclerosis Stroke is considered the second most common cause of dementia , but the magnitude of the risk posed by stroke has not been fully clarified . The aim of this study was to determine the long-term risk of developing dementia after stroke onset in a hospitalized cohort . We prospect ively examined 185 nondemented patients aged ≥60 years hospitalized with ischemic stroke and 241 age-matched nondemented controls without stroke from the same community using neurologic , neuropsychological , and functional assessment s given annually . Using criteria modified from the DSM-III-R , we diagnosed incident dementia based on the annual examination findings . We used life-table methods to estimate incidence in the two groups , Kaplan-Meier analysis to determine the proportion surviving without dementia , and Cox proportional-hazards analysis to compute the relative risk ( RR ) of dementia after 1 to 4 years of follow-up . The incidence of dementia was 8.4 per 100 person-years in the stroke group and 1.3 per 100 person-years in the control group . After 52 months of follow-up , the cumulative proportion ( ±SE ) surviving without dementia was 66.3 ± 5.5 % for stroke and 90.3 ± 4.3 % for control subjects . The RR of dementia associated with stroke compared with controls was 5.5 ( 95 % CI , 2.5 to 11.1 ) after adjusting for demographic factors . Older age at stroke onset and fewer years of education were significant covariates , but sex and race were not . A low score on the Mini-Mental State Examination at baseline was a significant predictor when added to this model . We conclude that ischemic stroke in elderly persons increases the long-term risk of developing dementia by approximately five-fold compared with those without stroke . Age , education , and baseline intellectual function contribute independently to that risk The agreement between neuropsychologists identifying cognitive impairment ( CI ) in older adults was examined , as were factors influencing the classification process . Twenty four ne
Output:
| However , currently no definitive evidence of an association between increased IMT and cognitive impairment can be established . |
MS212264 | ***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 This single-blind r and omised clinical trial compared osteopathic manipulative treatment with chemonucleolysis ( used as a control of known efficacy ) for symptomatic lumbar disc herniation . Forty patients with sciatica due to this diagnosis ( confirmed by imaging ) were treated either by chemonucleolysis or manipulation . Outcomes ( leg pain , back pain and self-reported disability ) were measured at 2 weeks , 6 weeks and 12 months . The mean values for all outcomes improved in both groups . By 12 months , there was no statistically significant difference in outcome between the treatments , but manipulation produced a statistically significant greater improvement for back pain and disability in the first few weeks . A similar number from both groups required additional orthopaedic intervention ; there were no serious complications . Crude cost analysis suggested an overall financial advantage from manipulation . Because osteopathic manipulation produced a 12-month outcome that was equivalent to chemonucleolysis , it can be considered as an option for the treatment of symptomatic lumbar disc herniation , at least in the absence of clear indications for surgery . Further study into the value of manipulation at a more acute stage is warranted BACKGROUND Shock-absorbing and biomechanic shoe orthoses are frequently used in the prevention and treatment of back and lower extremity problems . One review concludes that the former is clinical ly effective in relation to prevention , whereas the latter has been tested in only 1 r and omized clinical trial , concluding that stress fractures could be prevented . OBJECTIVES To investigate if biomechanic shoe orthoses can prevent problems in the back and lower extremities and if reducing the number of days off-duty because of back or lower extremity problems is possible . DESIGN Prospect i ve , r and omized , controlled intervention trial . STUDY SUBJECTS One female and 145 male military conscripts ( aged 18 to 24 years ) , representing 25 % of all new conscripts in a Danish regiment . METHOD Health data were collected by question naires at initiation of the study and 3 months later . Custom-made biomechanic shoe orthoses to be worn in military boots were provided to all in the study group during the 3-month intervention period . No intervention was provided for the control group . Differences between the 2 groups were tested with the chi-square test , and statistical significance was accepted at P < .05 . Risk ratio ( RR ) , risk difference ( ARR ) , numbers needed to prevent ( NNP ) , and cost per successfully prevented case were calculated . OUTCOME VARIABLES Outcome variables included self-reported back and /or lower extremity problems ; specific problems in the back or knees or shin splints , Achilles tendonitis , sprained ankle , or other problems in the lower extremity ; number of subjects with at least 1 day off-duty because of back or lower extremity problems and total number of days off-duty within the first 3 months of military service because of back or lower extremity problems . RESULTS Results were significantly better in an actual-use analysis in the intervention group for total number of subjects with back or lower extremity problems ( RR 0.7 , ARR 19 % , NNP 5 , cost 98 US dollars ) ; number of subjects with shin splints ( RR 0.2 , ARR 19 % , NNP 5 , cost 101 US dollars ) ; number of off-duty days because of back or lower extremity problems ( RR 0.6 , ARR < 1 % , NNP 200 , cost 3750 US dollars ) . In an intention-to-treat analysis , a significant difference was found for only number of subjects with shin splints ( RR 0.3 , ARR 18 % , NNP 6 cost 105 US dollars ) , whereas a worst-case analysis revealed no significant differences between the study groups . CONCLUSIONS This study shows that it may be possible to prevent certain musculoskeletal problems in the back or lower extremities among military conscripts by using custom-made biomechanic shoe orthoses . However , because care-seeking for lower extremity problems is rare , using this method of prevention in military conscripts would be too costly . We also noted that the choice of statistical approach determined the outcome OBJECTIVES This level II outcome study was conducted to examine the efficacy and toxicity of a diagnostic and treatment protocol using electrodermal screening ( EDS ) in allergy/sensitivity patients . METHODS Ninety-six patients with a diagnosis of allergy or sensitivity entered the study between 1994 and 1998 ; 90 participants completed the study . All participants followed the same protocol , and all interactions were with a single clinician at a single site . The Allergy Symptom Severity Index ( ASSI ) was developed to record symptomatic information . EDS - conductance measurement 1/ ( - of specific acupuncture points was used as an objective endpoint ( indicator of outcome ) and for identification of antigens , according to Voll criteria . All measurements were taken before and after treatment , and EDS was carried out at all treatment sessions . Outcome criteria suggesting efficacy were reduction in ASSI score , reduction in number of items testing positive , and normalization of conductance measurements . A statistical analysis of the outcomes was performed using the student 's paired t-test . RESULTS There was a statistically significant change in pre- and post-treatment measurements of the ASSI . The conductance measurements normalized and the number of items testing positive decreased compared to pre-treatment testing . In addition to these parameters , 87.2 percent of subjects rated efficacy as good to excellent , and less than one-percent rated the outcome as poor . The outcome demonstrated longevity , meaning that people who had their post-treatment evaluation up to three years after primary treatment were still showing minimal ASSI scores , with no additional treatment . The treatment appeared to work equally well across age groups and gender . Forty-eight percent of participants had an aggravation of symptoms after treatment , lasting an average of 10 hours , with reactions described as mild to moderate . Average cost of the desensitization protocol ( all costs included ) was $ 822.16 . CONCLUSIONS This protocol demonstrated efficacy without serious toxicity and no long-term adverse effects . It is natural , non-invasive , and does not require long periods of avoidance of offending foods or environmental stimuli . The desensitization protocol is a low-cost , effective therapy for the treatment of patients suffering from symptoms of allergy/sensitivity disease Postoperative oral nutritional supplementation has been shown to be of clinical benefit . This study examined the clinical effects and cost of administration of oral supplements both before and after surgery BACKGROUND Re source -based relative value scales ( RBRVS ) have become a st and ard method for identifying costs and determining reimbursement for physician services . Development of RBRVS systems and methods are review ed , and the RBRVS concept of physician " work " is defined . OBJECTIVE Results of work and time inputs from chiropractic physicians are compared with those reported by osteopathic and medical specialties . Last , implication s for reimbursement of chiropractic fee services are discussed . METHODS Total work , intraservice work , and time inputs for clinical vignettes reported by chiropractic , osteopathic , and medical physicians are compared . Data for chiropractic work and time reports were drawn from a national r and om sample of chiropractors conducted as part of a 1997 workers ' compensation chiropractic fee schedule development project . Medical and osteopathic inputs were drawn from RBRVS research conducted at Harvard University under a federal contract reported in 1990 . Both data sets used the same or similar clinical vignettes and similar methods . Comparisons of work and time inputs are made for clinical vignettes to assess whether work reported by chiropractors is of similar magnitude and variability as work reported by other specialties . RESULTS Chiropractic inputs for vignettes related to evaluation and management services are similar to those reported by medical specialists and osteopathic physicians . The range of variation between chiropractic work input and other specialties is of similar magnitude to that within other specialties . Chiropractors report greater work input for radiologic interpretation and lower work input for manipulation services . CONCLUSIONS Chiropractors seem to perform similar total " work " for evaluation and management services as other specialties . No basis exists for excluding chiropractors from using evaluation and management codes for reimbursement purpose s on grounds of dissimilar physician time or work estimates . Greater work input by chiropractors in radiology interpretation may be related to a greater importance placed on findings in care planning . Consistently higher reports for osteopathic work input on manipulation are likely attributable to differences in reference vignettes used in the respective population s. Research with a common reference vignette used for manipulation providers is recommended , as is development of a single generic approach to coding for manipulation services Purpose . To determine whether practice of the Transcendental Meditation ( TM ) technique can affect medical expenses . Design . The evaluation was a quasi experimental , longitudinal , cost-minimization study . Setting . Province of Quebec , Canada . Subjects . This study involved 1418 Quebec health insurance enrollees who practice d the TM technique compared with 1418 subjects who were r and omly selected from enrollees of the same age , sex , and region . TM subjects had chosen to begin the technique prior to learning about and choosing to enter the study . Measures . This 14-year , pre- and postintervention study retrospectively assessed government payments to physicians for treating the TM and comparison groups . Other medical expense data for individuals were unavailable . Data were inflation-adjusted . For each subject , least squares regression slopes were calculated to estimate pre- and postintervention annual rates of change in payments . We compared the groups ' means and 1 % , 5 % , and 10 % trimmed means ( robust estimators ) of the slopes . Results . Before starting meditation , the yearly rate of increase in payments between groups was not significantly different ( p > .17 ) . After commencing meditation , the TM group 's mean payments declined 1 % to 2 % annually . The comparison group 's payments increased up to 11 . 73 % annually over 6 years . There was a 13 . 78 % mean annual difference ( p = .0017 ) . Conclusions . The results suggest that the TM technique reduced payments to physicians between 5 % and 13 % annually relative to comparison subjects over 6 years . R and omized studies are recommended OBJECTIVES To measure the marginal costs of providing complementary medicine services ( mostly homoeopathy ) in outpatient clinics for patients with rheumatoid arthritis ( RA ) and to illustrate how parameters to which the cost of complementary medicine may be sensitive can be identified . DESIGN Retrospective , observational costing study . SETTING The outpatient clinic of the Royal London Homoeopathic Hospital . SUBJECTS R and om sample of 89 patients from the 427 ( RA ) patients attending outpatient clinics from April 1995 to March 1996 . MAIN OUTCOME MEASURES The marginal costs incurred by the hospital of treating 89 patients attending outpatient clinics and the relative contribution of the different re sources to the total costs . RESULTS The total costs of treating 89 patients were 7,124 Pounds of which 543 Pounds was assumed to be fixed and the remainder variable . The marginal costs of treating additional patients , starting from zero patients treated , are presented . Consultation time ( doctors and dietician ) contributed to 29 % of the total costs , non-conventional drugs contributed to 22 % of the total costs . CONCLUSIONS Underst and ing the marginal costs of providing complementary care to RA patients will inform the debate over whether these therapies are likely to be cost-effective . In addition , those who would like to explore the practicalities of establishing a service involving complementary medicine will gain an underst and ing of the likely provider costs . The cost of complementary medicine appears to be most sensitive to the time spent with the patient by the doctor Abstract Objective : To evaluate the cost effectiveness of physiotherapy , manual therapy , and care by a general practitioner for patients with neck pain . Design : Economic evaluation alongside a r and omised controlled trial . Setting : Primary care . Participants : 183 patients with neck pain for at least two weeks recruited by 42 general practitioners and r and omly allocated to manual therapy ( n=60 , spinal mobilisation ) , physiotherapy ( n=59 , mainly exercise ) , or general practitioner care ( n=64 , counselling , education , and drugs ) . Main outcome measures : Clinical outcomes were perceived recovery , intensity of pain , functional disability , and quality of life . Direct and indirect costs were measured by means of cost diaries that were kept by patients for one year . Differences in mean costs between groups , cost effectiveness , and cost utility ratios were evaluated by applying non-parametric bootstrapping techniques . Results : The manual therapy group showed a faster improvement than the physiotherapy group and the general practitioner care group up to 26 weeks , but differences were negligible by follow up at 52 weeks . The total costs of manual therapy ( € 447 ; £ 273 ; $ 402 ) were around one third of the costs of physiotherapy ( € 1297 ) and general practitioner care ( € 1379 ) . These differences were significant : P<0.01 for manual therapy versus physiotherapy and manual therapy versus general practitioner care and P=0.55 for general practitioner care versus physiotherapy . The cost effectiveness ratios and the cost utility ratios showed that manual therapy was less costly and more effective than physiotherapy or general practitioner care . Conclusions : Manual therapy ( spinal mobilisation ) is more effective and less costly for treating neck pain than physiotherapy or care by a general practitioner . What is already known on this topic The cost of treating neck pain is considerable Many conservative interventions are available , such as prescription drugs , yet their cost effectiveness has not been evaluated No r and omised trials of conservative treatment for neck pain have so far included an economic evaluation What this study adds Manual therapy is more effective and less costly than physiotherapy or care by a general practitioner for treating neck pain Patients undergoing manual therapy recovered more quickly than those
Output:
| These exemplary studies indicate CAM therapies that may be considered cost-effective compared to usual care for various conditions : acupuncture for migraine , manual therapy for neck pain , spa therapy for Parkinson 's , self-administered stress management for cancer patients undergoing chemotherapy , pre- and post-operative oral nutritional supplementation for lower gastrointestinal tract surgery , biofeedback for patients with " functional " disorders ( eg , irritable bowel syndrome ) , and guided imagery , relaxation therapy , and potassium-rich diet for cardiac patients . |
MS212265 | ***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 purpose of this study was to evaluate the haemodynamic changes during induction , as well as the speed and quality of recovery when propofol ( vs thiopentone and /or halothane ) was used for induction and maintenance of anaesthesia in paediatric out patients . One hundred unmedicated children , 3–12-yr-old , scheduled for ambulatory surgery were studied . The most common surgical procedures performed were eye muscle surgery ( 42 % ) , plastic surgery ( 21 % ) , dental restoration ( 15 % ) , and urological procedures ( 15 % ) . The children were r and omized to an anaesthetic regimen for induction/maintenance as follows : propofol/propofol infusion ; propofol/halothane ; thiopentone/halothane ; halothane for both induction and maintenance . Succinylcholine 1.5 mg · kg−1 was used to facilitate tracheal intubation and N2O/O2 were used as the carrier gases in each case . All maintenance drugs were titrated according to the clinical response of the patient to prevent movement and /or maintain BP ± 20 % of baseline . Two patients ( 4 % ) who received propofol expressed discomfort during injection . The mean propofol dose required to prevent movement was 267 ± 83 μg · kg−1 · min−1 . The overall pattern of haemodynamic changes , as well as awakening ( extubation ) times were not different among the four groups . Children who received propofol recovered faster ( 22 vs 29–36 min ) ( P < 0.05 ) , were discharged home sooner ( 101 vs 127–144 min ) ( P < 0.05 ) , and had less postoperative vomiting ( 4 vs 24–48 % ) ( P < 0.05 ) than all others . There were no serious complications or adverse postoperative sequelae in any of the patients in the study . It is concluded that induction and maintenance of anaesthesia with propofol is a well-tolerated anaesthetic technique in children , and is associated with faster recovery and discharged as well as less vomiting than when halothane is used . RésuméL’objet de cette étude est d’évaluer les changements hémodynamiques à l’induction ainsi que la vitesse et la qualité du réveil , lorsque le propofol ( versus thiopental et/ou halothane ) est utilisé pour l’induction et l’entretien de l’anesthésie d’enfants en ambulatoire . On a étudié 100 enfants dépourvus de traitement , entre 3 et 12 ans , programmés pour une chirurgie ambulatoire . Les chirurgies les plus habituelles sont la cure de strabisme ( 42 % ) , la chirurgie plastique ( 21 % ) , la restauration dentaire ( 15 % ) et les interventions urologiques ( 15 % ) . Les enfants sont distribués aléatoirement pour une anesthésie d’induction/entretien comme suit : propofol/infusion de propofol ; propofol/ halothane ; thiopental/halothane ; halothane pour l’induction et l’entretien . On a utilisé la succinylcholine 1,5 mg · kg−1 pour faciliter l’intubation trachéale et le N2O/O2 est utilisé comme véhicule gazeux dans tous les cas . Pour l’entretien de l’anesthésie , les agents sont titrés en fonction de la réponse clinique du patient afin de prévoir les mouvements et/ou de maintenir la pression artérielle à ±20 % de la valeur de base . Deux patients ( 4 % ) ont manifesté un inconfort pendant l’injection de propofol . La dose moyenne de propofol requise pour prévenir le mouvement est de 267 ± 83 μg · kg−1 · min−1 . Autant le profil général des variations hémodynamiques que le moment du réveil ( extubation ) sont identiques dans les quatre groupes . Les enfants qui reçoivent le propofol se réveillent plus vite ( 22 secondes versus 29–36 min ) , ( P < 0,05 ) sont renvoyés plus tôt à la maison ( 101 versus 127–144 min ) ( P < 0,05 ) et ont moins de vomissements post-opératoires ( 4 versus 24–48 % ) ( P < 0,05 ) . Il n’y a pas eu de complications sérieuses ni de séquelles postopératoires chez aucun des patients de l’étude . On en conclut que l’induction et l’entretien de l’anesthésie avec le propofol est une technique bien tolérée chez l’enfant , associée avec un réveil et un départ plus rapides ainsi que des vomissements moindres que lors de l’utilisation d’halothane The incidence of postoperative nausea and vomiting and requirements for anti-emetic medication were assessed in 80 female patients undergoing day-case anaesthesia during assisted conception therapy . Anaesthesia was induced with alfentanil 50 μg · kg−1 and propofol 1 mg · kg−1 ; atracurium 0.5 mg · kg−1 was given to facilitate tracheal intubation . The patients were allocated to receive either total intravenous maintenance of anaesthesia with an infusion of propofol and increments of alfentanil ( Group P ) or inhalational maintenance of anaesthesia with nitrous oxide and enflurane ( Group E ) . Postoperative nausea , retching , vomiting , requirements for anti-emetic therapy , and unplanned admission for overnight stay in hospital were recorded . Overall incidence of nausea was 64 % in group E and 39 % in Croup P ( P < 0.05 ) . Incidence of vomiting was 67 % in Group E and 34 % in Group P ( P < 0.05 ) . Metoclopramide was requested by 62 % of patients in Group E , and 32 % of those in Group P ( P < 0.05 ) ; 21 % of the patients in Group E were admitted to hospital overnight , while only 5 % of the patients in Group P required unscheduled admission to hospital ( P < 0.05 ) . We conclude that total intravenous anaesthesia with propofol and alfentanil is superior to inhalational maintenance with nitrous oxide and enflurane in that it is associated with less nausea and vomiting , less requirement for anti-emetic medication , and a lower probability of unplanned admission to hospital after day-care gynaecological surgery . RésuméL’incidence de nausées et vomissements en période postopératoire et le besoin de médication antiémétique a été évalué chez 80 patientes devant subir une anesthésie ( cas d’un jour ) pendant une séance de conception assistée . L’induction de l’anesthésie s’est faite à l’aide d’alfentanil 50 μg · kg−1 et de propofol 1 mg · kg−1 ; l’intubation endotrachéale a été facilitée à l’aide d’atracurium 0,5 mg · kg−1 . L’anesthésie était maintenue soit à l’aide d’une technique intraveineuse totale , en utilisant une infusion de propofol et des bolus d’alfentanil ( groupe P ) , soit à l’aide d’une technique d’inhalation en utilisant le protoxyde d’azote et l’enflurane ( groupe E ) . Pendant la période postopératoire , les nausées , les efforts de vomissement , les vomissements , le besoin de thérapie antiémétique , et les admissions hospitalières imprévues pour une nuit étaient notés . L’incidence globale de nausées était de 64 % dans le groupe E et 39 % dans le groupe P ( P < 0,05 ) . L’incidence de vomissements était de 67 % dans le groupe E et de 34 % dans le groupe P ( P < 0,05 ) . Soixante-deux pourcent des patientes du groupe E ont dem and é du métoclopramide , comparativement à 32 % du groupe P ( P < 0,05 ) ; 21 % des patientes du grope E ont été admises à l’hôpital pour une nuit , t and is que seulement 5 % des patientes du groupe P l’ont été ( P < 0,05 ) . Nous concluons que l’anesthésie à l’aide d’une technique intraveineuse totale , avec propofol et alfentanil , est supérieure à une anesthésie par inhalation à l’aide de protoxyde d’azote et d’enflurane car elle est associée à une incidence moins élevée de nausées et vomissements , un besoin moindre de médication antiémétique , et une probabilité plus faible d’admissions hospitalières imprévues après une chirurgie gynécologique d’un jour This study was an authors comparison of the effects of and recovery from anesthesia in healthy , premedicated pediatric out patients who received either inhaled anesthetics ( group 1 ) or propofol ( group 2 ) . Group 1 ( n = 68 ) averaged 3.8 + /- 0.2 yr and weighed 17.7 + /- 0.8 kg , whereas group 2 ( n = 75 ) averaged 3.3 + /- 0.2 yr and weighed 16.3 + /- 0.6 kg . The incidence of vomiting in the Postanesthetic Care Unit ( PACU ) and from discharge to the first postoperative morning was lower in the group receiving propofol ( 0 % and 18 % ) than in the group receiving volatile agents ( 7 % and 34 % , P < 0.05 ) . The incidence of airway obstruction during induction of anesthesia was higher ( 34 % vs 10 % , P < 0.01 ) in children receiving inhaled agent . Withdrawal of the extremity with propofol injection occurred in 14 ( 19 % ) patients . Arterial blood pressure was higher at loss of consciousness , laryngoscopy , and tracheal intubation in group 2 ( P < 0.01 ) . The length of time from the end of surgery to extubation of the trachea , recovery scores , and length of time spent in the PACU and the Day Surgery Unit were the same in the two groups . Pain scores obtained in the PACU were not different . The data indicate that propofol can be used safely to induce and maintain anesthesia in healthy pediatric out patients . This coupled with the low incidence of vomiting and airway obstruction in the propofol group suggests distinct and compelling reasons to consider using the drug in this patient population STUDY OBJECTIVES To assess the quality of anesthesia and recovery and the frequency of postanesthetic retching and vomiting with propofol anesthesia for pediatric strabismus surgery . DESIGN R and omized , open , prospect i ve study . SETTING University hospital . PATIENTS Forty children scheduled for strabismus surgery . INTERVENTIONS The 40 patients were all premedicated with oral midazolam and received intraoperative opioids . They were divided into two groups : Twenty children received propofol at induction , followed by maintenance of anesthesia with propofol infusion and an oxygen-nitrous oxide ( O2-N2O ) mixture . The other 20 children received thiopental sodium at induction , followed by isoflurane in an O2-N2O mixture . MEASUREMENTS AND MAIN RESULTS At induction , pain and spontaneous movements were seen significantly more with propofol ( 11 of 20 vs. 0 of 20 for pain and 13 of 20 vs. 0 of 20 for spontaneous movements ; p < 0.001 ) , whereas thoracic rigidity was observed only with thiopental sodium ( 4 of 20 ) . During maintenance of anesthesia , significantly more oculocardiac reflexes were seen with propofol ( 10 of 20 vs. 3 of 20 ; p < 0.02 ) . The interval between termination of anesthesia and extubation was significantly shorter with propofol ( 13 minutes vs. 16 minutes ; p < 0.02 ) . For the first 24 hours after surgery , significantly less retching and vomiting were observed in the propofol group ( 4 of 20 vs. 11 of 20 ; p = 0.02 ) . CONCLUSIONS Propofol induction and maintenance of anesthesia for strabismus surgery in children significantly lowers the frequency of postanesthetic retching and vomiting , but propofol is associated with pain and spontaneous movements at induction and a high frequency of oculocardiac reflexes during maintenance infusion We have compared the recovery profiles of 163 healthy Chinese children after general anaesthesia for minor surgical procedures . Patients were allocated r and omly to receive one of four anaesthetic techniques : propofol infusion for induction and maintenance using a pharmacokinetic model-controlled syringe pump set initially at a target concentration of 8 micrograms ml-1 and then adjusted according to clinical requirements ; propofol 2.5 - 3.5 mg kg-1 , thiopentone 4 - 5 mg kg-1 or 2 - 3 % halothane for induction of anaesthesia followed by 1 - 2 % halothane for maintenance of anaesthesia . All patients breathed a mixture of 70 % nitrous oxide in oxygen through a laryngeal mask airway and received an appropriate regional anaesthetic block
Output:
| The effect of propofol on PONV was dependent mainly on the method of administration , time of measurement and range of control event rates .
In all other situations the difference between propofol and control may have reached statistical significance but was of doubtful clinical relevance . |
MS212266 | ***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: Background Illiteracy , a universal problem , limits the utilization of the most widely used short cognitive tests . Our objective was to assess and compare the effectiveness and cost for cognitive impairment ( CI ) and dementia ( DEM ) screening of three short cognitive tests applicable to illiterates . Methods Phase III diagnostic test evaluation study was performed during one year in four Primary Care centers , prospect ively including individuals with suspicion of CI or DEM . All underwent the Eurotest , Memory Alteration Test ( M@T ) , and Phototest , applied in a balanced manner . Clinical , functional , and cognitive studies were independently performed in a blinded fashion in a Cognitive Behavioral Neurology Unit , and the gold st and ard diagnosis was established by consensus of expert neurologists on the basis of these results . Effectiveness of tests was assessed as the proportion of correct diagnoses ( diagnostic accuracy [ DA ] ) and the kappa index of concordance ( k ) with respect to gold st and ard diagnoses . Costs were based on public prices at the time and hospital accounts . Results The study included 139 individuals : 47 with DEM , 36 with CI , and 56 without CI . No significant differences in effectiveness were found among the tests . For DEM screening : Eurotest ( k = 0.71 [ 0.59–0.83 ] , DA = 0.87 [ 0.80–0.92 ] ) , M@T ( k = 0.72 [ 0.60–0.84 ] , DA = 0.87 [ 0.80–0.92 ] ) , Phototest ( k = 0.70 [ 0.57–0.82 ] , DA = 0.86 [ 0.79–0.91 ] ) . For CI screening : Eurotest ( k = 0.67 [ 0.55–0.79 ] ; DA = 0.83 [ 0.76–0.89 ] ) , M@T ( k = 0.52 [ 0.37–0.67 ] ; DA = 0.80 [ 0.72–0.86 ] ) , Phototest ( k = 0.59 [ 0.46–0.72 ] ; DA = 0.79 [ 0.71–0.86 ] ) . There were no differences in the cost of DEM screening , but the cost of CI screening was significantly higher with M@T ( 330.7±177.1 € , mean±sd ) than with Eurotest ( 294.1±195.0 € ) or Phototest ( 296.0±196.5 € ) . Application time was shorter with Phototest ( 2.8±0.8 min ) than with Eurotest ( 7.1±1.8 min ) or M@T ( 6.8±2.2 min ) . Conclusions Eurotest , M@T , and Phototest are equally effective . Eurotest and Phototest are both less expensive options but Phototest is the most efficient , requiring the shortest application time INTRODUCTION The changeover to the new currency has meant that the Money test , a screening test for dementia with a number of advantages over those currently available , is now of no use . AIMS Our aim was to perform a preliminary evaluation of the Eurotest , which is a version of the Money test adapted to the new currency system . SUBJECTS AND METHODS DESIGN phase I , diagnostic evaluation ( convenience sampling ; pre-test prevalence 50 % ) . SUBJECTS > 65 years with no sensory deficit ; 30 with mild dementia and 30 without dementia . METHOD evaluation of socio-demographic variables and of mini-mental performance ( MMSE ) , Pfeiffer 's test ( SPMSQ ) , the seven-minute test ( 7MT ) and Eurotest . Statistical study : comparison between groups using t test and chi squared , depending on the variables ; determination of diagnostically useful parameters and ROC curves , with their respective 95 % confidence intervals ; linear regression study with a step by step strategy . RESULTS The groups did not differ as regards age , sex , level of schooling , degree of literacy , employment and knowledge of money systems . The Eurotest has a sensitivity of 0.93 ( 0.76 - 0.99 ) and a specificity of 0.87 ( 0.68 - 0.96 ) , which is similar to that of the MMSE and the 7MT . The Eurotest ( 6.77 + /- 1.65 min ) takes less time than the 7MT ( 8.87 + /- 1.81 min ) and is not modified by the subject 's clinical situation . The level of schooling does not affect the results of the Eurotest . CONCLUSIONS The Eurotest is simple , quick , valid , useful and is unaffected by the level of schooling , which are features that make it a valid alternative to the tests currently available Background To assess and compare the effectiveness and costs of Phototest , Mini Mental State Examination ( MMSE ) , and Memory Impairment Screen ( MIS ) to screen for dementia ( DEM ) and cognitive impairment ( CI ) . Methods A phase III study was conducted over one year in consecutive patients with suspicion of CI or DEM at four Primary Care ( PC ) centers . After undergoing all screening tests at the PC center , participants were extensively evaluated by research ers blinded to screening test results in a Cognitive-Behavioral Neurology Unit ( CBNU ) . The gold st and ard diagnosis was established by consensus of expert neurologists . Effectiveness was assessed by the proportion of correct diagnoses ( diagnostic accuracy [ DA ] ) and by the kappa index of concordance between test results and gold st and ard diagnoses . Costs were based on public prices and hospital accounts . Results The study included 140 subjects ( 48 with DEM , 37 with CI without DEM , and 55 without CI ) . The MIS could not be applied to 23 illiterate subjects ( 16.4 % ) . For DEM , the maximum effectiveness of the MMSE was obtained with different cutoff points as a function of educational level [ k = 0.31 ( 95 % Confidence interval [ 95%CI ] , 0.19 - 0.43 ) , DA = 0.60 ( 95%CI , 0.52 - 0.68 ) ] , and that of the MIS with a cutoff of 3/4 [ k = 0.63 ( 95%CI , 0.48 - 0.78 ) , DA = 0.83 ( 95%CI , 0.80 - 0.92 ) ] . Effectiveness of the Phototest [ k = 0.71 ( 95%CI , 0.59 - 0.83 ) , DA = 0.87 ( 95%CI , 0.80 - 0.92 ) ] was similar to that of the MIS and higher than that of the MMSE . Costs were higher with MMSE ( 275.9 ± 193.3 € [ mean ± sd euros ] ) than with Phototest ( 208.2 ± 196.8 € ) or MIS ( 201.3 ± 193.4 € ) , whose costs did not significantly differ . For CI , the effectiveness did not significantly differ between MIS [ k = 0.59 ( 95%CI , 0.45 - 0.74 ) , DA = 0.79 ( 95%CI , 0.64 - 0.97 ) ] and Phototest [ k = 0.58 ( 95%CI , 0.45 - 0.74 ) , DA = 0.78 ( 95%CI , 0.64 - 0.95 ) ] and was lowest for the MMSE [ k = 0.27 ( 95%CI , 0.09 - 0.45 ) , DA = 0.69 ( 95%CI , 0.56 - 0.84 ) ] . Costs were higher for MMSE ( 393.4 ± 121.8 € ) than for Phototest ( 287.0 ± 197.4 € ) or MIS ( 300.1 ± 165.6 € ) , whose costs did not significantly differ . Conclusion MMSE is not an effective instrument in our setting . For both DEM and CI , the Phototest and MIS are more effective and less costly , with no difference between them . However , MIS could not be applied to the appreciable percentage of our population who were illiterate OBJECTIVE Fototest is a short simple test , applicable to illiterate subjects and not influenced by educational level . The purpose of this study is to assess its validity for cognitive impairment ( CI ) and dementia ( DEM ) under routine clinical practice conditions . MATERIAL AND METHODS A cross-sectional , multicentre and naturalistic study conducted in General Neurology clinics . The subjects were , over 60 years old , with a previously established diagnosis of no cognitive impairment ( NoCI ) , cognitive impairment without dementia ( CInoDEM ) , or dementia ( DEM ) . The discriminant validity was assessed using the area under the ROC curve ( AUC ) , sensitivity ( Sn ) , specificity ( Sp ) , and probability coefficients . Partial correlations were calculated , adjusted for age , sex and education level with Eurotest , verbal fluency test ( VFT ) and Global Deterioration Scale ( GDS ) score to evaluate the concurrent and construct validity . RESULTS Nineteen neurologists included a total of 589 subjects : 361 NoCI , 106 CINoDEM and 122 DEM . The discriminant value was better for DEM ( AUC 0.94 ± 0.02 ) than for CI ( 0.86 ± 0.02 ) . For DEM the best cut-off point was 26/27 ( Sn=0.88 [ 95 % CI , 0.93 - 0.97 ] , Sp=0.87 [ 95 % CI , 0.84 - 0.90 ] ) ; and for CI , 28/29 ( Sn=0.71 [ 95 % CI , 0.65 - 0.77 ] , Sp=0.84 [ 95 % CI , 0.80 - 0.88 ] ) . Fototest showed a high and significant correlation with Eurotest ( r=0.70 ± 0.02 ) , VFT ( r=0.68 ± 0.02 ) and the GDS score ( r=-0.77 ± 0.02 ) . CONCLUSION The Fototest showed adequate validity for CI and DEM in general Neurology clinics in an extensive and wide geographical area INTRODUCTION The recently developed Phototest is a simple , easy and very brief ( <3 minutes ) test with theoretical advantages over available dementia screening tests . Our objective was to evaluate its diagnostic accuracy under routine clinical conditions . MATERIAL AND METHODS A phase II cross-sectional validation study of diagnostic tests was performed in a sample of 308 patients referred to a general neurology department and in a group of 70 healthy individuals . The diagnostic accuracy ( DA ) of the Phototest was assessed and compared with that of the Eurotest and a verbal fluency test ( VFT ) in relation to the clinical diagnosis of dementia ( DEM ) and cognitive impairment ( CI ) by calculating the area under the ROC curve ( aROC ) and determining Sensitivity ( Se ) , Specificity ( Sp ) and likelihood ratios . RESULTS The total sample comprised 225 subjects without CI ( NOR ) , 58 with CI and without DEM and 95 with DEM . Phototest results showed a normal distribution in NOR subjects ( 33.4 + /- 3.9 [ mean + /- st and ard desviation ] ) and were not influenced by educational variables . The DA of the Phototest for DEM and CI ( 0.95 + /- 0.01 [ aRO C+/- Se ] ) was similar to that of the Eurotest and higher for both tests than that of the VFT . The cutoff points of 25/26 for DEM ( Se=0.88 [ 0.80 - 0.94 ] , Sp=0.90 [ 0.86- 0.93 ] ) and 28/29 for CI ( Se=0.90 [ 0.84 - 0.94 ] , Sp=0.90 [ 0.83 - 0.93 ] ) maximised the sum of Se and Sp . CONCLUSIONS The Phototest is a very short test of easy application that is applicable to illiterate subjects , uninfluenced by educational variables and useful to identify CI and DEM in routine clinical practice
Output:
| Conclusion Phototest has good diagnostic accuracy for dementia and cognitive impairment .
It is brief , simple and can be used in illiterate persons .
This makes it suitable for use in primary care setting s and /or in subjects with low educational level |
MS212267 | ***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 authors compared the accuracy of conventionally prepared smears and smears prepared by an automated , fluid-based , thin-layer processing device in the detection of cytologic abnormalities . A total of 3218 patients from five centers took part in this study , in which a single cervical sample was split into a matched pair . The conventional smear was made in the routine fashion ; the remainder of the cells on the sampling device were rinsed into a transport-fixation fluid . A slide was then prepared from the solution using the thin-layer processor . Diagnostic findings identified on the two preparations were compared in a blinded fashion , and a discrepancy resolution procedure was used to eliminate screening differences . Overall , there was a high correlation in the diagnoses of the two methods . For low- grade or more severe disease , the thin-layer method result ed in a 13 % increase in the rate of detection , as compared with the conventional Papanicolaou smear technique OBJECTIVE To obtain preliminary data on the Roche CytoRich thin-layer system for the preparation of gynecologic cytology specimens , derived from a pre clinical startup evaluation of the instrument and comparing the CytoRich method to conventional smears . STUDY DESIGN At six different clinical sites , 286 pairs of conventional and CytoRich slides derived from the same patient sample were compared for the following : final Bethesda classification diagnosis , specimen adequacy and presence of microorganisms . RESULTS The study showed agreement between the methods for an exact Bethesda diagnosis in 78 % and agreement within one Bethesda diagnosis category in 95 % . The CytoRich method diagnosed more cases of squamous intraepithelial lesion ( SIL ) than did the conventional method , and the differences in SIL detection were statistically significant . The CytoRich method identified similar numbers of cases with microorganisms as did the conventional smears , and the CytoRich system improved overall specimen adequacy as compared to the conventional method , with fewer cases of unsatisfactory and less-than-optimal smears . CONCLUSION The CytoRich method may improve the overall sensitivity and specificity of the cervical cytology procedure . Clinical trials to verify these preliminary data are ongoing OBJECTIVE To examine the efficacy of the ThinPrep method , an automated , fluid-based technique for the collection and preparation of exfoliated and aspirated cells in cervical cytology . STUDY DESIGN A total of 251 patients participated . From each patient a sample was obtained by scraping with a wooden spatula , split and prepared with both conventional Papanicolaou and ThinPrep methods . In the ThinPrep processor , epithelial cells were homogenized in a vial of preservative solution and r and omly sample d onto a microscopic slide . From a single vial of sample suspension a series of 10 ThinPrep slides of the same quality were made . All cells were concentrated within an approximately 20-mm-diameter circle in a uniform , thin layer on the ThinPrep slide . RESULTS Twenty-five percent of the screening area , 10 % of the epithelial cells observed and 50 % of the screening time were required to arrive at a final diagnosis as compared with the Papanicolaou smear . Virtually complete concurrence was ascertained between the Papanicolaou and ThinPrep diagnoses , for direct agreement of 95.3 % and agreement within one diagnostic grade of 99.5 % . CONCLUSION An overall improvement was ascertained in the preparation of microscopic slides and the recognition of abnormal cells with the ThinPrep method OBJECTIVE To compare the AutoCyte PREP direct-to-vial procedure to the conventional Pap smear in two large and similar patient groups compiled from the testing experience of three cytology laboratories in Switzerl and and France . STUDY DESIGN R and omly selected , large patient groups were evaluated using either the conventional Pap smear or the AutoCyte PREP direct-to-vial liquid-based preparation . Results were then compared statistically as to disease detection and sample adequacy . RESULTS Specimen adequacy was greatly improved in the group tested with the AutoCyte PREP . PREP also demonstrated a significant reduction in ASCUS and ASCUS : LSIL+ ratios . The three laboratories participating in this review found significantly improved detection of both low and high grade SIL . Routine use of AutoCyte PREP for cervical cytology screening offers substantial improvements in adequacy and disease detection OBJECTIVE To compare the cytologic diagnoses and specimen adequacy of the ThinPrep Pap Test with historical data within a distinct patient population to assess test performance and its impact on clinical practice . STUDY DESIGN A total of 16,314 ThinPrep Pap tests were processed and evaluated at Fletcher Allen Health Care over a seven-month period . A subset of 8,574 tests from a selected provider group ( cohort ) was compared to the historical conventional cervical cytologic smear data from the cohort population for both cytologic diagnoses and specimen adequacy . The cohort consisted of 12 practice groups , including 60 physicians and providers , utilizing the ThinPrep Pap Test as their primary cervical cancer screening sampling technique . Cytologic diagnoses and specimen adequacy were classified using the Bethesda system . RESULTS Using a three-tiered diagnostic system similar to the Cytyc clinical trials ( within normal limits [ WNL ] , atypical squamous cells of undetermined significance [ASCUS]/atypical gl and ular cells of undetermined significance [ AGUS ] and low grade squamous intraepithelial lesion and higher [LSIL]+ ) , the ThinPrep method increased the percentage of cases that could be definitively diagnosed as WNL by 1.71 % , lowered the percentage of ambiguous or borderline cases diagnosed as ASCUS/AGUS by 26.59 % and increased the percentage of cases diagnostic of LSIL+ by 52.15 % in the cohort population . Further subdivision by the Bethesda classification showed that the identification of infectious agents increased 25.51 % and the detection of high grade squamous intraepithelial lesion/carcinoma increased 55.14 % . Concurrently , cases reported as benign cellular changes ( reactive/reparative ) decreased 23.1 % , and the percentage of cases reported as unsatisfactory/"limited by ... " was reduced 52.71 % . Histologic correlation of cases reported as squamous intraepithelial lesion revealed that the percentage of patients with subsequent benign biopsies was reduced by 31.7 % utilizing the ThinPrep technique . Further , the percentage of ThinPrep patients with histologically confirmed cervical intraepithelial neoplasia ( CIN ) 1 and CIN 2/3 increased by 16.3 % and 9.3 % , respectively . CONCLUSION Implementation of the ThinPrep Pap Test result ed in statistically significant improvements in both diagnostic yield and specimen adequacy , as seen by others in clinical trials . Comparison of results to historical data within a cohort population reinforced earlier data and lent further support to the cl aim that the ThinPrep Pap Test is " significantly more effective " than the conventional smear in clinical practice OBJECTIVE To eliminate the disadvantages and inherent bias of split- sample studies by evaluating the relative performance of monolayers and conventional cervical cytologic smears in a single laboratory through evaluation of two large and similar , r and omly derived patient groups from the same geographical and demographically similar population . STUDY DESIGN Two r and omly created large patient groups from the same population were evaluated using conventional microscopic screening . One group was tested using the conventional smear . The other was evaluated using only the new liquid-preservative-based CytoRich preparation ( AutoCyte , Inc. , Elon College , North Carolina , U.S.A. ) with the intended direct-tovial cell collection method . Results were then compared statistically as to disease detection and sample adequacy . RESULTS Age comparisons between the two groups demonstrated equivalency . Specimen adequacy was greatly improved in the group tested with the CytoRich monolayer preparation . The monolayer group also demonstrated a significant reduction in ambiguous atypical squamous cells of undetermined significance /atypical gl and ular cells of undetermined significance diagnoses and a threefold increase in the detection of squamous intraepithelial lesion and cancer . CONCLUSION Routine use of homogeneous monolayer preparations as a total replacement for the conventional smear can be expected to dramatically improve specimen adequacy and sensitivity of the conventional smear alone . Direct-to-vial use of the new monolayer preparation generated significantly better results than those shown in any of the earlier split- sample trials OBJECTIVE To compare the CytoRich system with conventional cervical cytology in a university medical center hospital laboratory . STUDY DESIGN The CytoRich system combines liquid preservation , selective reduction of blood/inflammation , thin-layer preparation and discrete staining . Two thous and thirty-two parallel conventional and CytoRich sample s were examined as part of a multicenter trial of the CytoRich/AutoCyte systems . Same-patient conventional and CytoRich slides were su bmi tted to separate cytotechnologists blindly . The results were compared , and all nonmatching sample pairs were review ed again . A consensus diagnosis was derived for all cases . The initial readings of the CytoRich and conventional smears were compared with each other and with the consensus diagnosis . RESULTS Of the 148 squamous intraepithelial lesions ( SILs ) found by either method , 85 % were found by CytoRich , while only 58.5 % were found by conventional smear . As compared with the consensus diagnosis , CytoRich slides had 86.7 % sensitivity for SIL and 99.1 % specificity , while the conventional slides had 63.6 % sensitivity and 99.7 % specificity . Consensus review result ed in upgrading to SIL in 1.8 % of conventional slides and 1.4 % of CytoRich slides . The biopsy correlation results were similar for the two methods . CONCLUSION The CytoRich system affords excellent cellular presentations and superior sensitivity for SILs when compared to the conventional technique OBJECTIVE To assess specimen adequacy of the ThinPrep slide preparation method in routine use . STUDY DESIGN Two studies , a feasibility study of 299 women and a clinical study of 499 women , were conducted . A broom-type collection device was used and rinsed directly into Pre-servCyt vials . Slides were prepared with the ThinPrep 2000 device , screened and classified according to the Bethesda System . The proportion of ThinPrep slides described as " Satisfactory But Limited By : No Endocervical Component ( SBLB : No ECC ) " was then compared to the proportion of SBLB : No ECC slides found on conventional smears in a previously conducted clinical trial of over 7,000 patients . RESULTS For the feasibility study the proportion of ThinPrep slides described as SBLB : No ECC was 9.36 % as compared to the clinical trial combined rate of 9.4 % for conventional smears . For the clinical study , 4.96 % of ThinPrep slides were SBLB : No ECC as compared to the 4.4 % SBLB : No ECC rate for conventional smears from the same clinical trial . The proportions were statistically equivalent for both studies . CONCLUSION It is expected that the rate of representing endocervical component will be maintained when the ThinPrep preparation method is used routinely in place of the conventional cytologic smear method Several studies have examined the role of tests for human papillomavirus ( HPV ) in screening for cervical cancer but as yet the relevance is unclear . We looked at HPV testing for types 16 , 18 , 31 , and 33 on material taken at the time of a cervical smear in 2009 eligible women having routine screening . Women with any degree of dyskaryosis or high levels of one of these HPV types were referred for colposcopy . 44 % of the cervical intraepithelial neoplasia ( CIN ) lesions of grade 2/3 detected had negative cytology and were found only by HPV testing . A further 22 % of the CIN 2/3 lesions were positive for HPV but showed only borderline or mild cytological changes . The positive predictive value of HPV testing was 42 % , which was similar to that for moderate dyskaryosis . HPV types 16 and 31 were more sensitive and specific for CIN 2/3 than were types 18 or 33 . However , 25 % of the CIN 2/3 lesions were not detected by these four HPV tests . We suggest that HPV testing could usefully augment but not replace conventional cytology . These results should stimulate a much larger r and omised trial to assess the impact of these improved CIN 2/3 detection rates on the subsequent incidence of invasive cancer Objective To compare the cytologic diagnoses and specimen adequacy of a fluid-based , thin-layer preparation and conventional Papanicolaou tests . Methods A total of 7360 women from six separate sites — three screening centers and three hospitals — participated in split- sample /matched-pair , double-masked clinical trials . A conventional Papanicolaou test was performed , after which residual material on the sampling device was rinsed into a fluid preservative from which a thin-layer slide ( ThinPrep ) was prepared using the ThinPrep 2000 automated slide processor ( Cytyc Corp. , Boxborough , MA ) . Conventional and ThinPrep slides were read independently . Cytologic diagnoses and specimen adequacy were classified using the Bethesda system . Results For the three screening centers , 65 % more diagnoses of low- grade squamous intraepithelial lesions and higher were made on the ThinPrep slides ( P < .001 ) ; for the three hospital centers , 6 % more of these diagnoses were made with the ThinPrep method ( P = .294 ) . Comparison of specimen adequacy showed a significant increase in satisfactory spec
Output:
| Effectiveness There is some evidence that liquid-based cytological methods offer the following advantages over traditional smear techniques : • a reduction in the proportion of inadequate specimens • an improvement in sensitivity • a possible reduction in specimen interpretation times .
Conclusions From the evidence available , it is likely that the liquid-based cytology technique will reduce the number of false-negative test results , reduce the number of unsatisfactory specimens and may decrease the time needed for examination of specimens by cytologists .
In this review , it became clear that increasing the coverage of the programme , and the use of more effective cervical specimen collection devices are also important ways of reducing the burden of the invasive cervical cancer . |
MS212268 | ***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 whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than acupuncture that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries Abstract Varicella , or chickenpox , is very communicable and has been shown to be transmitted to nearly 90 % of household contacts . Severe varicella infections with fatal complications have been noted in children receiving corticosteroids despite the administration of varicella-zoster immune globulin ( VZIG ) . The use of post-exposure acyclovir prophylaxis in immunocompetent children exposed to a household contact with varicella has been shown to decrease the transmission rate of varicella significantly . We studied the safety and efficacy of acyclovir prophylaxis as an adjunctive preventive measure in 8 children ( 10 separate exposures ) receiving corticosteroids for renal disease . Four children ( 6 separate exposures ) served as controls . No adverse reactions were reported with the acyclovir prophylaxis . The maximum change between pre- and study serum creatinine levels was 0.1 mg/dl . None of the 8 patients who received acyclovir prophylaxis developed chickenpox . One of these 8 patients developed humoral immunity to varicella despite the absence of clinical infection . One of 4 patients who received VZIG prophylaxis alone developed chickenpox . These data support the use of acyclovir prophylaxis as an adjunctive measure to VZIG for the prevention of potentially serious varicella infection in children receiving steroids BACKGROUND Respiratory tract infections are among the most common diseases both in adults and children . METHODS This multicentre study , was carried out in 212 patients ( 118 adults with chronic respiratory diseases and 94 children with recurrent respiratory infections ) at six Italian study centres . It was performed to establish the efficacy of Lantigen B for the prevention of bacterial complications and /or reduction of associated symptoms . Lantigen B is an oral product based on bacterial lysates of six different inactivated strains commonly involved in respiratory tract infections . RESULTS The results of prophylactic treatment with Lantigen B in the population investigated were as follows : - the mean incidence of recurrence in the pediatric patients over the 6-month observation period of the study was 1.643 in the placebo group and 1.211 in the Lantigen B group ( a relative reduction of 35.7 % ) ; - the mean incidence of recurrence in the adult patients over the 6-month observation period of the study was 0.73 in the placebo group and 0.56 in the Lantigen B group ( a relative reduction of 30.4 % ) . The improvement in other important parameters , such as the number of days with a high temperature , cough , and catarrh in the children and objective clinical findings at the lymph nodes of the neck , chest , and pharyngotonsillar region in the adults , provides further evidence of the efficacy of Lantigen B. CONCLUSIONS This study demonstrates Lantigen B 's effectiveness in the prevention of bacterial complications and suggests that it can be used in patients who are particularly at risk of infection ( children , the elderly , diabetics , and immunocompromised patients ) or those in whom an infection might aggravate a clinical picture that is already inherently complicated ( diabetics again , but also patients with heart , kidney , or liver disease ) Infection has been recognized as an important cause of morbidity and mortality in children with nephrotic syndrome . However , the incidence and severity of infection and the mechanisms responsible for the increased susceptibility to infection are still unclear in adults . We studied 86 consecutive adult patients with nephrotic syndrome but no diabetic nephropathy . Risk factors for infection were evaluated by logistic regression analysis . Infections were found in 16 patients ( 19 % ) , of whom six died of infection and two developed end-stage renal failure associated with infection . The relative risk for bacterial infection among patients with serum immunoglobulin G ( IgG ) levels below 600 mg/dL was 6.74 compared with that for patients with serum IgG levels over 600 mg/dL ( 95 % confidence interval , 1.22 to 36.32 ; P = 0.029 ) . In patients with serum creatinine levels over 2.0 mg/dL , the relative risk of bacterial infection was 5.31 compared with patients with serum creatinine levels below 2.0 mg/dL ( 95 % confidence interval , 1.08 to 26.09 ; P = 0.040 ) . Intravenous immunoglobulin ( 10 to 15 g ) was administered prospect ively every 4 weeks to 18 patients with serum IgG levels below 600 mg/dL until serum IgG levels increased to over 600 mg/dL. Administration of immunoglobulin result ed in a decreased rate of bacterial infections to a level equal to that in patients with endogenous levels over 600 mg/dL. These data indicate that hypogammaglobulinemia and renal insufficiency are independent risk factors for bacterial infection in adult patients with nephrotic syndrome . The effects of intravenous immunoglobulin suggest that maintenance of serum IgG levels over 600 mg/dL may reduce the risk of infection Abstract Renal-biopsy specimens from Nigerian children with the nephrotic syndrome were studied by fluorescence microscopy after staining with fluorescein isothiocyanate-labelled antibodies against human immunoglobulins and complement ( β-1-C ) . In all patients bound immunoglobulin and complement were observed , characteristically in the form of granular deposits along the glomerular capillary walls . Electron microscopy showed deposition of immune complexes along the epithelial side of the glomerular basement membrane , and reactive changes in epithelial and endothelial cells . Antibody eluted from the kidney of one patient gave precipitates with preparations containing Plasmodium malariœ antigens , but no reaction with P. falciparum or normal kidney antigens . Immune complexes containing P. malariœ antigen are thought to play a causal role in the aetiology of the nephrotic syndrome of African children Children with sickle cell anemia have an increased susceptibility to bacterial infections , especially to those caused by Streptococcus pneumoniae . We therefore conducted a multicenter , r and omized , double-blind , placebo-controlled clinical trial to test whether the regular , daily administration of oral penicillin would reduce the incidence of documented septicemia due to S.pneumoniae in children with sickle cell anemia who were under the age of three years at the time of entry . The children were r and omly assigned to receive either 125 mg of penicillin V potassium ( 105 children ) or placebo ( 110 children ) twice daily . The trial was terminated 8 months early , after an average of 15 months of follow-up , when an 84 percent reduction in the incidence of infection was observed in the group treated with penicillin , as compared with the group given placebo ( 13 of 110 patients vs. 2 of 105 ; P = 0.0025 ) , with no deaths from pneumococcal septicemia occurring in the penicillin group but three deaths from the infection occurring in the placebo group . On the basis of these results , we conclude that children should be screened in the neonatal period for sickle cell hemoglobinopathy and that those with sickle cell anemia should receive prophylactic therapy with oral penicillin by four months of age to decrease the morbidity and mortality associated with pneumococcal septicemia OBJECTIVE To evaluate the safety and immunogenicity of varicella vaccine in children with nephrotic syndrome , including those taking low-dose , alternate-day prednisone . STUDY DESIGN Prospect i ve , open-label , multicenter clinical trial of varicella vaccine in a 2-dose regimen in US and Canadian children ( 12 months to < 18 years ) with nephrotic syndrome . Varicella Zoster Virus ( VZV ) antibody levels were measured after the first and second vaccine dose and yearly for 2 years . Patients were monitored for adverse reactions to vaccine , exposure to varicella , dermatomal zoster , and chickenpox . RESULTS Twenty-nine children , mean age 4.9 ( SD 1.9 ) years , 45 % receiving every-other-day steroids , received 2 vaccine doses . All patients seroconverted and had VZV antibody levels considered protective against breakthrough varicella ( > or=5 gpELISA units ) after 2 doses . At 2-year follow-up , all patients retained detectable antibody , and 91 % ( 21 of 23 ) had levels > or=5 gpELISA units . There were no adverse events associated with vaccination . CONCLUSIONS Varicella vaccine was generally well tolerated and highly immunogenic in children with nephrotic syndrome , including those on low-dose , alternate-day prednisone In order to study the preventive efficiency of IVIgG on nosocomial infection(NI ) , 54 cases of the children with nephrotic syndrome(NS ) were r and omly divided into 2 groups , test group(n = 22 ) and control group(n = 32 ) . Routine treatment was adopted to all cases . Besides the routine treatment , the test group was injected with IVIgG(100 - 300 mg.kg-1.d-1 ) for 2 - 3 days . The results showed that the NI rate of test group ( 13.6 % ) was significantly lower than that of the control(46.88 % ) ( P < 0.05 ) , and the hospital days of the test group(27.33 + /- 15.51 ) d was significantly shorter than that of the control(64.50 + /- 18.52 ) d ( P < 0.05 ) . These suggest that IVIgG , as one of the ways to prevent NI , can improve the immune state and effectively prevent the NI in the children with NS
Output:
| REVIEW ERS ' CONCLUSIONS IVIG , thymosin and TIAOJINING may have positive effects on prevention of nosocomial or unspecified infection with no obvious serious adverse events in children with nephrotic syndrome .
However the method ological quality of all trials was poor , the sample sizes small and all studies were from China , and thus there is no strong evidence on the effectiveness of these interventions |
MS212269 | ***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 Pressure ulcers are an important source of morbidity and suffering for patients and a formidable burden on caregivers . OBJECTIVES To assess the impact of a feeding formula enriched with fish oil on healing of preexisting pressure ulcers and serum levels of C-reactive protein in critical care patients . METHODS Adult patients with pressure ulcers grade II or higher were r and omly allocated to receive either a formula enriched with fish oil or an isocaloric control formula . Wound healing was assessed by using the Pressure Ulcer Scale for Healing tool on days 7 , 14 , and 28 . Blood levels of C-reactive protein were measured on days 0 , 7 , and 14 . RESULTS Baseline demographics did not differ between the study ( n = 20 ) and the control ( n = 20 ) groups . The mean score on the ulcer healing tool increased significantly ( P = .02 ) from day 0 to day 28 in the control group ( from 9.25 [ SD , 2.12 ] to 10.75 [ SD , 3.41 ] ) compared with the study group ( from 9.10 [ SD , 2.84 ] to 9.40 [ SD , 3.72 ] ) . Mean levels of C-reactive protein decreased significantly ( P= .02 ) from day 0 to day 14 in the study group ( from 191 [ SD , 104.4 ] mg/L to 111.7 [ SD , 97.8 ] mg/L ) compared with the control group ( from 145 [ SD , 90 ] mg/L to 139 [ SD , 62 ] mg/L ) . CONCLUSION Administration of a feeding formula enriched with fish oil was associated with decreased progression of pressure ulcers and a decrease in blood concentrations of C-reactive protein BACKGROUND & AIMS Nutrients putatively implicated in pressure ulcer healing were evaluated in a clinical setting . METHODS Sixteen in patients with a stage 2 , 3 or 4 pressure ulcer r and omised to receive daily a st and ard hospital diet ; a st and ard diet plus two high-protein/energy supplements ; or a st and ard diet plus two high-protein/energy supplements containing additional arginine ( 9 g ) , vitamin C ( 500 mg ) and zinc ( 30 mg ) . Nutritional status measurements ( dietary , anthropometric and biochemical ) and pressure ulcer size and severity ( by PUSH tool ; Pressure Ulcer Scale for Healing ; 0=completely healed , 17=greatest severity ) were measured weekly for 3 weeks . RESULTS Patients ' age and BMI ranges were 37 - 92 years and 16.4 - 28.1 k g/m2 ) respectively . Baseline PUSH scores were similar between groups ( 8.7+/-0.5 ) . Only patients receiving additional arginine , vitamin C and zinc demonstrated a clinical ly significant improvement in pressure ulcer healing ( 9.4+/-1.2 vs. 2.6+/-0.6 ; baseline and week 3 , respectively ; P<0.01 ) . All patient groups presented with low serum albumin and zinc and elevated C-reactive protein . There were no significant changes in biochemical markers , oral dietary intake or weight in any group . CONCLUSIONS In this small set of patients , supplementary arginine , vitamin C and zinc significantly improved the rate of pressure ulcer healing . The results need to be confirmed in a larger study Measuring progress toward healing is fundamental to the management of pressure ulcers . A method to assess progress of an individual ulcer over time is lacking . Given the limitations of currently available instruments and the need for a precise and practical method of monitoring healing in clinical practice , the National Pressure Ulcer Advisory Panel initiated the development of a new tool for measuring pressure ulcer healing . The key elements in developing an instrument include simplicity of use in clinical setting s , validity for measuring whether ulcers are improving or worsening , and sensitivity to changes in the ulcer between observations . A new tool incorporating surface area , exu date amount , and surface appearance is proposed . Content validity , correlation validity , prospect i ve validity , and sensitivity to change can be met by the proposed Pressure Ulcer Scale for Healing instrument AIMS To investigate whether a nutritional intervention in older women and men with femoral neck fracture had an effect on postoperative complications during hospitalization and on nutritional status at a four-month follow-up . METHODS The design was a r and omized controlled trial . The present study sample consisted of 157 patients aged 70 years and above with femoral neck fracture . The nutritional intervention included , among other things , a nutritional journal to detect nutrition deficiencies and protein-enriched meals for at least four days postoperatively . Further , at least two nutritional and protein drinks were served each day during the whole hospitalization and other factors that would influence the patient 's nutrition were also considered and dealt with . Postoperative complications were registered and patients were assessed using the Mini Nutritional Assessment ( MNA ) scale , including body mass index ( BMI ) , on admission and at a four-month follow-up . RESULTS Malnutrition was common and low MNA scores were associated with postoperative complications such as delirium and decubitus ulcers . There were significantly fewer days of delirium in the intervention group , seven patients in the intervention group developed decubitus ulcers vs. 14 patients in the control group and the total length of hospitalization was shorter . There were no detectable significant improvements regarding nutritional parameters between the intervention and the control group at the four-month follow-up but men improved their mean BMI , body weight and MNA scores in both the intervention and the control groups while women deteriorated in both groups . CONCLUSIONS Malnutrition was common among older people with hip fractures admitted to hospital . The nutritional intervention might have contributed to the patients suffering fewer days with delirium , fewer decubitus ulcers and shorter hospitalization but did not improve the long-term nutritional status , at least not in women . RELEVANCE TO CLINICAL PRACTICE This nutritional intervention , which was included in a multifactorial multidisciplinary intervention , is inexpensive and relatively easy to implement . It has significant effects on complications but no long-term effect on nutritional parameters , at least not in women UNLABELLED Bedsores prevention is part of the specific role of the nurse , as defined namely in the order 84 - 869 of the 17 . July 1984 . The analysis of the risk factors for the appearance of bedsores shows that immobilization , reduction of mobility linked to vigilance disorders and the urinary and faecal incontinence are major elements which justify protocol s of well defined local cares . More recently , the role of undernutrition was highlighted but the recommendations lack accuracy . The proteino-energizing undernutrition is frequent among the elderly patients in hospital , reaching 60 % of all the patients in the department of acute affections . The association of a constituted bedsore and of clinical and /or biological scars of protein-energizing undernutrition is demonstrated and justifies a re-feeding of the patients suffering from bedsores . On the other h and , although a bad nutrition state seems to favour the appearance of a bedsore , it is not proved that the nutrition intensification associating the diagnosis of an under-nutrition and the starting of an adapted re-feeding ( with enriched food or assistance ) decreases the actual incidence of the bedsores . A prospect i ve , multicentered , r and omized survey was therefore proposed . Its aim was to study the Influence of Nutrition in the Bedsores Prevention among the Elderly Patients in hospitals , suffering from acute affections . This research follows upon the preventions audits of bedsores and the nutrition protocol started up in a department of geriatrics intern medicine in the Regional Center of Geriatrics of Bordeaux . CONCLUSION Two results must be retained in this nursing survey . It gave the possibility of calling into question the professional experience of the nursing teams which participated to the research and to up date their knowledge in the field of the bedsores prevention . They could thus be acquainted with the existence of the grids which evaluate the risk of bedsore , the dependence or even the nutrition supply and to assess the interest for improving the cares quality . On the other h and , we highlighted the possibility of increasing the energy and protein supply by a distribution of enriched food supplements . Moreover , this action has had a beneficial influence in the bedsores prevention among the old people Pressure sores are a frequent problem , especially in elderly patients . Nutritional status may influence the incidence , progression and severity of pressure sores , data , however , are contradictory ( 1 ) . The purpose of this study was to determine the effect of supplemental feeding on the nutritional status and the development and severity of pressure sores . The effect of supplemental feeding overnight ( tube + ) on patients with a fracture of the hip and a high pressure-sore risk score , was studied in a r and omized clinical trial . The control group ( tube - ) had no supplemental feeding . After informed consent , 140 patients were r and omized , and 129 of these took part in the trial ( 62 tube + , and 67 tube - ) . Protein and energy intake , haemoglobin , serum albumin , total serum protein and pressure-sore grade were measured at admission and after 1 and 2 weeks . Of the 62 patients r and omized for tube feeding ( tube + ) , only 25 tolerated their tube for more than 1 week and 16 for 2 weeks . Nevertheless , energy and protein intake was significantly higher in the tube + group ( P < 0.001 ) . This , however , did not significantly influence total serum protein , serum albumin and development and severity of pressure sores after 1 and 2 weeks . Comparison of the actually tube fed group ( n=25 at 1 week , n = 16 at 2 weeks ) and the control group showed a 2 - 3 times higher protein and energy intake ( P < 0.0001 ) , and a significantly higher total serum protein and serum albumin after 1 and 2 weeks in the actually tube fed group ( all P < 0.001 ) . Pressure-sore development and severity were not significantly influenced in the actually tube fed group . We conclude that we were not able to show a significant decrease in development and severity of pressure sores , because the nasogastric tube for supplemental feeding was not well tolerated in this patient group . Nevertheless , tube feeding overnight does result in a significant higher protein and energy intake , and has a significant effect on nutritional status in the actually tube-fed group . Other means of supplemental feeding will have to be used in order to answer the question of whether supplemental feeding can decrease development and severity of pressure sores 59 elderly patients ( mean age 82 ) with femoral neck fractures were r and omised into two groups . 27 patients received daily an oral nutrition supplement ( 250 ml , 20 g protein , 254 kcal ) for a mean of 32 days ; 32 patients acted as controls . On admission most patients had nutritional deficiencies . Despite being offered adequate quantities , nutritional requirements were not met during the hospital stay . Clinical outcome was significantly better in the supplemented group ( 56 % favourable course vs 13 % in controls ) during the stay in the convalescent hospital . The rates of complications and deaths were also significantly lower in supplemented patients ( 44 % vs 87 % ) . 6 months after the fracture the rates of complications and mortality were significantly lower in supplemented patients ( 40 % vs 74 % ) . The median duration of hospital stay was significantly shorter in the supplemented group ( 24 vs 40 days ) . Thus the clinical outcome of elderly patients with femoral neck fracture can be improved by once daily dietary oral supplementation Objectives : To identify independent predictors for development of pressure ulcers in hospitalized patients and to develop a simple prediction rule for pressure ulcer development . Design : The Prevention and Pressure Ulcer Risk Score Evaluation ( prePURSE ) study is a prospect i ve cohort study in which patients are followed up once a week until pressure ulcer occurrence , discharge from hospital , or length of stay over 12 weeks . Data were collected between January 1999 and June 2000 . Setting : Two large hospitals in the Netherl and s. Participants : Adult patients admitted to the surgical , internal , neurological and geriatric wards for more than 5 days were eligible . A consecutive sample of 1536 patients was visited , 1431 ( 93 % ) of whom agreed to participate . Complete follow up data were available for 1229 ( 80 % ) patients . Main outcome measures : Occurrence of a pressure ulcer grade 2 or worse during admission to hospital . Results : Independent predictors of pressure ulcers were age , weight at admission , abnormal appearance of the skin , friction and shear , and planned surgery in coming week . The area under the curve of the final prediction rule was 0.70 after bootstrapping . At a cut off score of 20 , 42 % of the patient weeks were identified as at risk for pressure ulcer development , thus correctly identifying 70 % of the patient weeks in which a pressure ulcer occurred . Conclusion : A simple clinical prediction rule based on five patient characteristics may help to identify patients at increased risk for pressure ulcer development and in need of preventive measures Protein energy malnutrition is an important determinant of clinical outcome in older patients after hip fracture , but the effectiveness of nutritional support programs in routine clinical practice is controversial . We performed a prospect i ve , r and omized , controlled clinical trial to determine if nutritional supplementation decreased fracture-related complications in a selection of otherwise healthy patients with hip fractures . Patients were r and omized to intervention or control groups . The control group ( n = 40 ) was given ordinary hospital food and
Output:
| There was no clear evidence of an improvement in pressure ulcer healing from the nutritional supplements evaluated in any of these individual studies .
There is currently no clear evidence of a benefit associated with nutritional interventions for either the prevention or treatment of pressure ulcers . |
MS212270 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Residual renal function ( RRF ) in end-stage renal disease is clinical ly important as it contributes to adequacy of dialysis , quality of life , and mortality . This study was conducted to determine the predictors of RRF loss in a national r and om sample of patients initiating hemodialysis and peritoneal dialysis . The study controlled for baseline variables and included major predictors . The end point was loss of RRF , defined as a urine volume < 200 ml/24 h at approximately 1 yr of follow-up . The adjusted odds ratios ( AOR ) and P values associated with each of the demographic , clinical , laboratory , and treatment parameters were estimated using an " adjusted " univariate analysis . Significant variables ( P < 0.05 ) were included in a multivariate logistic regression model . Predictors of RRF loss were female gender ( AOR = 1.45 ; P < 0.001 ) , non-white race ( AOR = 1.57 ; P = < 0.001 ) , prior history of diabetes ( AOR = 1.82 ; P = 0.006 ) , prior history of congestive heart failure ( AOR = 1.32 ; P = 0.03 ) , and time to follow-up ( AOR = 1.06 per month ; P = 0.03 ) . Patients treated with peritoneal dialysis had a 65 % lower risk of RRF loss than those on hemodialysis ( AOR = 0.35 ; P < 0.001 ) . Higher serum calcium ( AOR = 0.81 per mg/dl ; P = 0.05 ) , use of an angiotensin-converting enzyme inhibitor ( AOR = 0.68 ; P < 0.001 ) . and use of a calcium channel blocker ( AOR = 0.77 ; P = 0.01 ) were independently associated with decreased risk of RRF loss . The observations of demographic groups at risk and potentially modifiable factors and therapies have generated testable hypotheses regarding therapies that may preserve RRF among end-stage renal disease patients Objective The goals for maintenance dialysis treatment are to improve patient survival , reduce patient morbidity , and improve patient quality of life . This is the first r and omized prospect i ve study comparing automated peritoneal dialysis ( APD ) and continuous ambulatory peritoneal dialysis ( CAPD ) treatment with respect to quality of life and clinical outcomes in relation to therapy costs . Design A prospect i ve , r and omized multicenter study . Setting Three Danish CAPD units . Patients Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included in the study . Twenty-five patients completed the study . Interventions After r and omization , 17 patients were allocated to APD treatment and 17 patients to CAPD treatment for a period of 6 months . Medical and biochemical parameters were evaluated at monthly controls in the CAPD units . Quality -of-life parameters were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey question naire supplemented with disease- and treatment-specific questions . Therapy costs were compared by evaluating dialysis-related expenses . Main Outcome Measures Quality -of-life parameters , dialysis-related complications , dialysis-related expenses . Results The quality -of-life studies showed that significantly more time for work , family , and social activities was available to patients on APD compared to those on CAPD ( p < 0.001 ) . Although the difference was not significant , there was a tendency for less physical and emotional discomfort caused by dialysis fluid in the APD group . Sleep problems , on the other h and , tended to be more marked in the APD group . Any positive effect of APD compared to CAPD on dialysis-related hospital days or complication rates could not be confirmed . With larger patient sample s , it is possible , however , that a significant difference might have been achieved . The running costs for APD treatment were US $ 75 per day and for CAPD treatment US $ 61 per day . Conclusion If APD treatment can help to keep selected patients vocationally or socially active , paying the extra cost seems reasonable Both CAPD-Y and CCPD have been reported to reduce the high peritonitis rate of conventional CAPD . As peritonitis was the major complication of CAPD in our centre , both modifications were introduced in 1987 . Initially , treatment modalities were allocated to patients based on their ( doctor 's ) preference . A remarkable difference in peritonitis rate was encountered between patients on CCPD and those on CAPD-Y ( 0.6 vs 1.2 episodes a year ) . As patient selection and doctor 's preference might have contributed to this hopeful result , a prospect i ve study was started . From January 1988 on , all new patients were at r and om assigned to CAPD-Y or CCPD in order to study the incidence of peritonitis in relation to the treatment modality . Up till November 1 , 1990 , 26 patients enrolled in the CAPD-Y group ( follow-up of 292 patient months ) , and 30 patients in the CCPD group ( follow-up of 337 patient months ) . This ongoing study reveals that CCPD patients remained peritonitis free significantly longer than those on CAPD-Y ( quartile time to first peritonitis greater than 12 vs 3 months , p less than 0.05 ) , and had a significantly lower peritonitis incidence ( median time to second peritonitis 18 vs 6 months , p = 0.016 ) . In conclusion , in an unselected patient population CCPD was accompanied with a significant lower peritonitis incidence than Several centers have reported a lower rate of peritonitis among adult patients on continuous cyclic peritoneal dialysis ( CCPD ) as compared to those undergoing continuous ambulatory peritoneal dialysis ( CAPD ) . Preliminary results of our ongoing prospect i ve r and omized study comparing CAPD-Y with CCPD also suggest a lower peritonitis incidence among CCPD-treated patients . To investigate whether the two dialysis regimens could result in differences in local host defense , we studied peritoneal macrophage ( PMO ) function and effluent opsonic activity in eight patients established on CAPD-Y matched with eight chronic CCPD patients . Since short and long dwell times are inherent to both dialysis modalities , and we previously found that dwell time has an impact on PMO function and effluent opsonic activity , patients were studied after both a short ( 4 hr ) and a long ( 15 hr ) dwell time . In both groups PMO phagocytic capacity increased significantly with dwell time ( 39 + /- 3.3 % at 4 hr vs. 58 + /- 4.2 % at 15 hr in CAPD patients , and 40 + /- 3.9 vs. 72 + /- 3.3 % in CCPD patients ; P less than 0.01 ) , as did PMO peak chemiluminescence response ( 31 + /- 4.9 vs. 77 + /- 7.2 counts.min-1/10(4 ) cells in CAPD , and 22 + /- 3.9 vs. 109 + /- 21.2 counts.min-1/10(4 ) cells in CCPD ; P less than 0.01 ) and effluent opsonic activity ( 41 + /- 7.6 vs. 73 + /- 5.8 % in CAPD and 39 + /- 6.2 vs. 70 + /- 5.9 % in CCPD ; P less than 0.01 ) . However , no significant difference was found in either variable between CAPD and CCPD patients when dwell times were equal . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Fluid and sodium removal rates may not be equivalent in patients undergoing automated peritoneal dialysis ( APD ) and continuous ambulatory peritoneal dialysis ( CAPD ) . This may influence compared cardiovascular outcomes in both groups . METHODS The authors compared prospect ively the time courses of ultrafiltration , sodium removal , and residual renal function ( RRF ) in a group of incident patients treated with CAPD ( n = 53 ) or APD ( n = 51 ) for at least 1 year ( mean follow-up , 28.9 months ; range , 13 to 62 ) . The authors analyzed potential effects of these factors on blood pressure ( BP ) control and cardiovascular morbidity and mortality . RESULTS Ultrafiltration and sodium removal rates were consistently lower in APD patients ( mean differences , 236 mL/d ; P = 0.012 , and 36 mmol/d ; P = 0.018 , respectively , end of first year ) . Moreover , univariate and multivariate analysis indicated that APD therapy results in a moderate , but significantly faster decline of RRF than CAPD therapy . Analysis of clinical outcomes showed that CAPD ( versus APD ) therapy or higher ultrafiltration or sodium removal rates were associated with a better time course of systolic , but not diastolic , BP . We were unable to identify PD modality , ultrafiltration , or sodium removal rates as independent predictors of cardiovascular morbidity and mortality . CONCLUSION Ultrafiltration and sodium removal rates are consistently lower in incident APD patients than in their counterparts undergoing CAPD . Moreover , RRF declines faster during APD than during CAPD therapy , although this difference may be partially counteracted by a detrimental effect of ultrafiltration on RRF . Aside from a better control of systolic BP in CAPD patients , these differences do not portend significant cardiovascular consequences during the first years of PD therapy Objectives To compare sodium removal in continuous ambulatory peritoneal dialysis ( CAPD ) and automated peritoneal dialysis ( APD ) patients , and to identify the main factors that modify Na removal in clinical practice in these patients . Design Study in three steps . Cross-sectional observational ( Study A ) , and longitudinal interventional ( Studies B and C ) . Patients and Methods First ( Study A ) we carried out a cross-sectional survey of Na removal in 63 patients on CAPD and 78 patients on APD . Second ( Study B ) , we studied Na removal in 32 patients before and after changing from CAPD to APD therapy . Finally ( Study C ) , we analyzed the impact on Na removal of introducing icodextrin for the long dwell in 16 patients undergoing CAPD or APD . Results In Study A , total Na removal averaged 210 mmol/day for CAPD patients and 91 mmol/day for APD patients ( p < 0.001 ) ; Na removal was < 100 mmol/day in 7.1 % of CAPD patients and 56.4 % of APD patients . Multivariate analysis identified ultrafiltration [ B = 125 mmol/day , 95 % confidence interval ( CI ) 110 , 140 ] , CAPD therapy ( B = 60 mmol/day , 95%CI 37 , 83 ) , and residual diuresis ( B = 51 mmol/L , 95%CI 34 , 69 ) as independent predictors of Na removal ( adjusted r2 = 0.76 ) . For APD patients , longer nocturnal dwell times and performing a supplementary diurnal exchange were also independently associated with higher Na removal rates . In Study B , Na removal decreased from 192 to 92 mmol/day ( median ) after the change to APD ( p = 0.02 ) . In Study C , peritoneal Na removal increased from 98 to 148 mmol/day ( median ) ( p = 0.04 ) after introducing icodextrin . Conclusions St and ard APD schedules are frequently associated with poor Na removal rates . For any degree of ultrafiltration , Na removal is better in CAPD than in APD . Icodextrin , supplementary diurnal exchanges , and longer nocturnal dwell times improve Na removal in APD . Sodium removal can be estimated from ultrafiltration in patients on CAPD , but must be specifically monitored in patients on APD An increasing number of patients are prescribed a continuous-cycling regimen because st and ard manual peritoneal-dialysis exchanges alone are not sufficient in achieving adequate dialysis as defined by the Dialysis Outcome Quality Initiative . Consequently , the number of patients on continuous-cycler therapy is increasing . There is controversy as to whether there are differences in the development of peritonitis between patients maintained on manual therapy and those on continuous cycling therapy . As a result , we retrospectively review ed the charts of all cycler peritoneal dialysis ( CPD ) patients maintained on either manual peritoneal dialysis ( Baxter UltraBag ; Group I ) or continuous cycler peritoneal dialysis ( Baxter HomeChoice Cycler ; Group II ) between 1 June 1994 and 31 December 1996 . A total of 239 patients were in Group I and 106 in Group II . Both groups were similar in age , race , gender , and presence of diabetes mellitus , coronary artery disease , peripheral vascular disease , and gastrointestinal disease . There was no difference in the overall rate of peritonitis between the two groups of patients [ 1 episode in 10.4 patient-months ( Group I ) vs. 1 in 10.0 patient-months ( Group II ) ; -0.01843 to 0.02619 ] . The rates of Staphylococcus aureus peritonitis [ 1 episode in 48.5 patient-months ( Group I ) vs. 1 in 141.8 patient months ( Group II
Output:
| Another study found that patients on APD had significantly more time for work , family and social activities .
AUTHORS ' CONCLUSIONS APD has not been shown to have significant advantages over CAPD in terms of important clinical outcomes .
APD may however be considered advantageous in select group of patients such as in the younger PD population and those in employment or education due to its psychosocial advantages . |
MS212271 | ***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 Amplification of the human epidermal growth factor receptor type 2 ( HER2 , also called HER2/neu ) gene and overexpression of its product in breast-cancer cells may be associated with responsiveness to anthracycline-containing chemotherapy regimens . METHODS In the r and omized , controlled Mammary.5 trial , we studied 639 formalin-fixed paraffin-embedded specimens obtained from 710 premenopausal women with node-positive breast cancer who had received either cyclophosphamide , epirubicin , and fluorouracil ( CEF ) or cyclophosphamide , methotrexate , and fluorouracil ( CMF ) as adjuvant chemotherapy . HER2 amplification or overexpression was evaluated with the use of fluorescence in situ hybridization , immunohistochemical analysis , and polymerase-chain-reaction analysis . RESULTS Amplification of HER2 was associated with a poor prognosis regardless of the type of treatment . In patients whose tumors showed amplification of HER2 , CEF was superior to CMF when assessed on the basis of relapse-free survival ( hazard ratio , 0.52 ; 95 percent confidence interval , 0.34 to 0.80 ; P=0.003 ) and overall survival ( hazard ratio , 0.65 ; 95 percent confidence interval , 0.42 to 1.02 ; P=0.06 ) . For women whose tumors lacked amplification of HER2 , CEF did not improve relapse-free survival ( hazard ratio for relapse , 0.91 ; 95 percent confidence interval , 0.71 to 1.18 ; P=0.49 ) or overall survival ( hazard ratio for death , 1.06 ; 95 percent confidence interval , 0.83 to 1.44 ; P=0.68 ) . The adjusted hazard ratio for the interaction between treatment and HER2 amplification was 1.96 for relapse-free survival ( 95 percent confidence interval , 1.15 to 3.36 ; P=0.01 ) and 2.04 for overall survival ( 95 percent confidence interval , 1.14 to 3.65 ; P=0.02 ) . CONCLUSIONS Amplification of HER2 in breast-cancer cells is associated with clinical responsiveness to anthracycline-containing chemotherapy . ( cancer.gov number , NCI-V90 - 0027 . ) BACKGROUND The use of high-dose adjuvant chemotherapy for high-risk primary breast cancer is controversial . We studied its efficacy in patients with 4 to 9 or 10 or more tumor-positive axillary lymph nodes . METHODS Patients younger than 56 years of age who had undergone surgery for breast cancer and who had no distant metastases were eligible if they had at least four tumor-positive axillary lymph nodes . Patients in the conventional-dose group received fluorouracil , epirubicin , and cyclophosphamide ( FEC ) every three weeks for five courses , followed by radiotherapy and tamoxifen . The high-dose treatment was identical , except that high-dose chemotherapy ( 6 g of cyclophosphamide per square meter of body-surface area , 480 mg of thiotepa per square meter , and 1600 mg of carboplatin per square meter ) with autologous peripheral-blood hematopoietic progenitor-cell transplantation replaced the fifth course of FEC . RESULTS Of the 885 patients , 442 were assigned to the high-dose group and 443 to the conventional-dose group . After a median follow-up of 57 months , the actuarial 5-year relapse-free survival rates were 59 percent in the conventional-dose group and 65 percent in the high-dose group ( hazard ratio for relapse in the high-dose group , 0.83 ; 95 percent confidence interval , 0.66 to 1.03 ; P=0.09 ) . In the group with 10 or more positive nodes , the relapse-free survival rates were 51 percent in the conventional-dose group and 61 percent in the high-dose group ( P=0.05 by the log-rank test ; hazard ratio for relapse , 0.71 ; 95 percent confidence interval , 0.50 to 1.00 ) . CONCLUSIONS High-dose alkylating therapy improves relapse-free survival among patients with stage II or III breast cancer and 10 or more positive axillary lymph nodes . This benefit may be confined to patients with HER-2/neu-negative tumors PURPOSE In 1992 , the Early Breast Cancer Trialists ' Collaborative Group reported that a meta- analysis of six r and omized trials in European and North American women begun from 1948 to 1972 demonstrated disease-free and overall survival benefit from adjuvant ovarian ablation . Approximately 350,000 new cases of breast cancer are diagnosed annually in premenopausal Asian women who have lower levels of estrogen than western women . PATIENTS AND METHODS From 1993 to 1999 , we recruited 709 premenopausal women with operable breast cancer ( 652 from Vietnam , 47 from China ) to a r and omized clinical trial of adjuvant oophorectomy and tamoxifen ( 20 mg orally every day ) for 5 years or observation and this combined hormonal treatment on recurrence . At later date s estrogen- and progesterone-receptor protein assays by immunohistochemistry were performed for 470 of the cases ( 66 % ) . RESULTS Treatment arms were well balanced . With a median follow-up of 3.6 years , there have been 84 events and 69 deaths in the adjuvant treatment group and 127 events and 91 deaths in the observation group , with 5-year disease-free survival rates of 75 % and 58 % ( P = .0003 unadjusted ; P = .0075 adjusted ) , and overall survival rates of 78 % and 70 % ( P = .041 unadjusted ) for the adjuvant and observation groups , respectively . Only patients with hormone receptor-positive tumors benefited from the adjuvant treatment . In Vietnam , for women unselected for hormone receptor status , a cost-effectiveness analysis suggests that this intervention costs $ 350 per year of life saved . CONCLUSION Vietnamese and Chinese women with hormone receptor-positive operable breast cancer benefit from adjuvant treatment with surgical oophorectomy and tamoxifen The aim of this study was to test the hypothesis of Goldie and Coldman that the use of non-cross-resistant regimens of chemotherapy could lead to maximal anti-tumour effect . We compared st and ard CMF ( cyclophosphamide , methotrexate , fluorouracil ) with alternating CMF/EV ( epirubicin , vincristine ) in the adjuvant therapy of early breast cancer . Stage II premenopausal node-positive or post-menopausal node-positive oestrogen receptor-negative and stage III breast cancer patients were eligible for the study . From January 1985 to December 1990 , 220 patients were r and omised ( 115 to CMF and 105 to CMF/EV ) . Toxicity was mild ; neurotoxicity , vomiting and hair loss were more frequent in the CMF/EV group , while permanent amenorrhoea , diarrhoea , stomach ache and minor infections occurred more often in the CMF arm . At a follow-up of 48 months , 113 patients ( 51.4 % ) had had recurrence ( 62 on CMF and 51 on CMF/EV ) and 54 ( 24.5 % ) had died ( 30 on CMF and 24 on CMF/EV ) . There was no significant difference in disease-free and overall survival between the two arms . After adjusting for menopausal status and stage , the relative risk ( RR ) of recurrence for CMF/EV patients was 0.93 ( 95 % CL 0.64 - 1.35 ) , while the RR of death was 0.85 ( 95 % CL 0.49 - 1.47 ) . In conclusion , the Goldie-Coldman model of alternating therapy is not confirmed in this trial of adjuvant therapy of early breast cancer , although in view of its design a difference of less than 20 % in 3 year disease-free survival could not be excluded The National Surgical Adjuvant Breast and Bowel Project ( NSABP ) implemented protocol B-15 to compare 2 months of Adriamycin ( doxorubicin ; Adria Laboratories , Columbus , OH ) and cyclophosphamide ( AC ) with 6 months of conventional cyclophosphamide , methotrexate , and fluorouracil ( CMF ) in patients with breast cancer nonresponsive to tamoxifen ( TAM , T ) . A second aim was to determine whether AC followed in 6 months by intravenous ( IV ) CMF was more effective than AC without reinduction therapy . Through 3 years of follow-up , findings from 2,194 patients indicate no significant difference in disease-free survival ( DFS , P = .5 ) , distant disease-free survival ( DDFS , P = .5 ) or survival ( S , P = .8 ) among the three groups . Since the outcome from AC and CMF was almost identical , the issue arises concerning which regimen is more appropriate for the treatment of breast cancer patients . AC seems preferable since , following total mastectomy , AC was completed on day 63 versus day 154 for conventional CMF ; patients visited health professionals three times as often for conventional CMF as for AC ; women on AC received therapy on each of 4 days versus on each of 84 days for conventional CMF ; and nausea-control medication was given for about 84 days to conventional CMF patients versus for about 12 days to patients on AC . The difference in the amount of alopecia between the two treatment groups was less than anticipated . While alopecia was almost universally observed following AC therapy , 71 % of the CMF patients also had hair loss and , in 41 % , the loss was greater than 50 % . This study and NSABP B-16 , which evaluates the worth of AC therapy in TAM-responsive patients , indicate the merit of 2 months of AC therapy for all positive-node breast cancer patients BACKGROUND Overexpression of the erbB-2 protein by breast cancer cells has been suggested to be a predictor of response to doxorubicin . A retrospective study was design ed to test this hypothesis . METHODS In National Surgical Adjuvant Breast and Bowel Project protocol B-11 , patients with axillary lymph node-positive , hormone receptor-negative breast cancer were r and omly assigned to receive either L-phenylalanine mustard plus 5-fluorouracil ( PF ) or a combination of L-phenylalanine mustard , 5-fluorouracil , and doxorubicin ( PAF ) . Tumor cell expression of erbB-2 was determined by immunohistochemistry for 638 of 682 eligible patients . Statistical analyses were performed to test for interaction between treatment and erbB-2 status ( positive versus negative ) with respect to disease-free survival ( DFS ) , survival , recurrence-free survival ( RFS ) , and distant disease-free survival ( DDFS ) . Reported P values are two-sided . RESULTS Overexpression of erbB-2 ( i.e. , positive immunohistochemical staining ) was observed in 239 ( 37.5 % ) of the 638 tumors studied . Overexpression was associated with tumor size ( P=.02 ) , lack of estrogen receptors ( P=.008 ) , and the number of positive lymph nodes ( P=.0001 ) . After a mean time on study of 13.5 years , the clinical benefit from doxorubicin ( PAF versus PF ) was statistically significant for patients with erbB-2-positive tumors -- DFS : relative risk of failure (RR)=0.60 ( 95 % confidence interval [CI]=0.44 - 0.83 ) , P=.001 ; survival : RR=0.66 ( 95 % CI=0.47 - 0.92 ) , P = .01 ; RFS : RR=0.58 ( 95 % CI=0.42 - 0.82 ) , P=.002 ; DDFS : RR=0.61 ( 95 % CI=0.44 - 0.85 ) , P=.003 . However , it was not significant for patients with erbB-2-negative tumors-DFS : RR=0.96 ( 95 % CI=0.75 - 1.23 ) , P=.74 ; survival : RR = 0.90 ( 95 % CI=0.69 - 1.19 ) , P=.47 ; RFS : RR=0.88 ( 95 % CI=0.67 - 1.16 ) , P=.37 ; DDFS : RR=1.03 ( 95 % CI=0.79 - 1.35 ) , P=.84 . Interaction between doxorubicin treatment and erbB-2 overexpression was statistically significant for DFS ( P=.02 ) and DDFS ( P=.02 ) but not for survival ( P= .15 ) or RFS ( P=.06 ) . CON
Output:
| HER2/neu overexpression and /or amplification was associated with greater efficacy of the anthracycline or taxane regimen .
Conclusions Current evidence supports the conclusion that the benefit of both anthracycline-based and taxane-based adjuvant chemotherapy is associated on HER2/neu status , with patients with HER2/neu-positive cancers benefiting more from these therapies than those with HER2/neu-negative cancers |
MS212272 | ***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: 19.552 R.P. is 2-Dimethylsulphamoyl-10 - 3(4(2-palmitoyloxyethyl ) piperidino-(1 ) ) propyl phenothiazine . It is the palmitic ester of 19.366 R.P. with rhe proposed generic name of pipotiazine . The substances were developed by the Rh6ne-Poulenc laboratories . Pipotiazine has neuroleptic properties , pharmacological studies and clinical trials indicating an effect in many ways resembling that of thioproperazine . The palmitic ester was developed in a search for a suitable depot preparation with a long duration of action . Pilot trials indicated a potent neuroleptic effect and marked depot properties . The pilot trials suggested that it might be sufficient to give injections of 19.552 R.P. at intervals of 4 weeks . A depot preparation with such a duration of action would have important advantages in the long-term treatment of chronic psychoses . I t could provide a very suitable pivot around which the necessary after-care of discharged patients could be organized , and in the hospital it could represent an effective and convenient way of administering the necessary neuroleptic treatment . With this background it w-as decided to try 19.552 R.P. in Opd01 Sykehus , a regional mental hospital in Norway . The trial aim ed to answer the following questions 1 . Twenty-one schizophrenic or schizoaffective patients with histories of cannabis abuse and operationally-defined syndromes of post-psychotic depression completed a double-blind trial of adjunctive imipramine added to their on-going medication regimen of fluphenazine decanoate and benztropine . 2 . The imipramine-treated patients had superior global outcome . 3 . Subscales suggested that specific improvement occurred in imipramine-treated patients in the domain of depression-like features . 4 . Psychotic symptomatology was not found to be exacerbated by the imipramine Undertaken in the context of a controlled drug trial involving newly admitted psychiatric hospital patients , this study compared the effectiveness of a " Doctor 's Choice " ( DC ) method of administering psychotropic drugs versus an experimentally determined treatment regimen employing r and om assignment and double-bline procedures . The 32-day drug trial sought to determine the comparative effectiveness of thioridazine-placebo , thioridazine-chlordiazepoxide , and thioridazine-imipramine , with the daily dosage of openly administered thioridazine ranging from 100 to 900 mg and dosages for chlordiazepoxide and imipramine , administered in a double-blind fashion , fixed at daily dosages of 30 and 75 mg , respectively . DC medication , consisting of a choice ( by a research physician ) of any of the three experimental medications determined on the basis of judged clinical need , was added as a fourth treatment category for present purpose s. Criteria of effectiveness included st and arized psychiatric rating scales and global measures of imporvement completed by research team members and ward physicians . Outcome results for the DC group compared to those for a single control group made up of individuals matched with DC patients on the basis of drug assignment indicated an essentially similar clinical effectiveness under both DC and control treatment conditions . Generalization of the finding was limited by the fact that the main treatment effect , attributable to thioridazine , overshadowed the more subtle action of the ancillary drugs Two drug trials in schizoaffective patients are reported . Nineteen " schizomanic " patients were treated for one month , on a double blind basis , with chlorpromazine or lithium and 41 " schizodepressive " patients with amitriptyline , chlorpromazine or both . In the schizodepressive patients there was a trend to a better response to chlorpromazine , but drug response generally was poor , only 20 per cent of patients recovering within the month . In the schizomanic patients lithium seemed as effective as chlorpromazine , which supports the view that these patients were suffering from a variant of mania BACKGROUND Schizophrenic patients have high rates of cigarette smoking compared with the general population . We compared sustained-release ( SR ) bupropion with placebo for smoking cessation in patients with schizophrenic disorders . We also examined how antipsychotic class predicts smoking cessation outcomes with bupropion . METHODS Thirty-two subjects meeting DSM-IV criteria for schizophrenia or schizoaffective disorder and nicotine dependence were r and omized to bupropion SR ( BUP , 300 mg/day ) or placebo ( PLA ) . Outcomes included treatment retention , smoking abstinence rates , expired breath carbon monoxide ( CO ) levels , psychotic symptoms , and medication side effects . RESULTS Bupropion significantly increased trial endpoint 7-day point prevalence smoking abstinence rates compared with placebo [ BUP , 8/16 ( 50.0 % ) , PLA , 2/16 ( 12.5 % ) ; chi(2 ) = 5.24 , df = 1 , p < .05 ] , and reduced CO levels during the trial [ Medication x Time interaction ; Z = 3.09 , p < .01 ] . Positive schizophrenia symptoms were not altered by BUP , but negative symptoms were significantly reduced . Atypical antipsychotic drug treatment enhanced smoking cessation responses to BUP . Major side effects were dry mouth , gastrointestinal symptoms , headache , and insomnia . CONCLUSIONS Our results suggest that 1 ) BUP enhances smoking abstinence rates compared with PLA in nicotine-dependent schizophrenic smokers ; 2 ) BUP is well-tolerated and safe for use in these patients ; and 3 ) atypical antipsychotics may enhance smoking cessation outcomes with BUP 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 negative symptoms of schizophrenia remain a major clinical challenge . Reboxetine is an antidepressant whose major mechanism of action is as a noradrenergic reuptake inhibitor . This study was a 6-week r and omized placebo-controlled trial of reboxetine or placebo add on to haloperidol 5 mg in the treatment of 30 patients with DSM-IV schizophrenia . The trial failed to demonstrate any significant difference between the placebo and reboxetine groups on any of the outcome measures . This trial does not suggest that increased noradreneregic drive mediated by reuptake inhibition in patients taking dopamine antagonists is of therapeutic value in schizophrenia The beneficial effect of atypical antipsychotic drugs ( APDs ) in treatment-resistant schizophrenia patients has been attributed , mostly , to their relatively high serotonergic (5-HT)2 to dopaminergic (D)2 receptor blockade ratio . We hypothesized that a combination of typical APDs ( D2 antagonists ) and mianserin , a potent 5-HT2 antagonist , might also exert superior efficacy in this population . Eighteen in patients with treatment-resistant schizophrenia who had an acute psychotic exacerbation of the disorder received , in a double-blind design , 30 mg/day mianserin ( n = 9 ) or placebo ( n = 9 ) in conjunction with typical neuroleptics [ haloperidol ( n = 9 ) or perphenazine ( n = 9 ) ] . Clinical status was evaluated before , during , and at the end of 6 weeks of combined treatment with the Brief Psychiatric Rating Scale ( BPRS ) , Scale for the Assessment of Positive Symptoms ( SAPS ) , Scale for the Assessment of Negative Symptoms and Hamilton Rating Scale for Depression . The typical APD/mianserin group exhibited significantly greater improvement in total BPRS scores ( 17.6 % versus 5.5%;P = 0.03 ) and a trend towards greater improvement in SAPS scores ( 35.3 % versus 13.0%;P = 0.07 ) . Our study indicates that patients with chronic treatment-resistant schizophrenia who have an acute psychotic exacerbation ( ‘ acute-on-chronic ’ ) may benefit from the addition of a potent 5-HT2 blocker , such as mianserin , to typical antipsychotics . Our findings may further emphasize the contribution of enhanced 5-HT2 blockade to the ‘ atypicality ’ of the atypical APDs and to their greater efficacy in alleviating symptoms of chronic treatment-resistant schizophrenia & NA ; The efficacy and safety of adding fluvoxamine to antipsychotic treatment in schizophrenic patients with mixed positive and negative symptoms was examined . Fifty‐three patients selected for persistent negative and positive symptoms who were receiving antipsychotic treatment were r and omly allocated to additional fluvoxamine ( 50‐100 mg / day ) or placebo in a double‐blind manner . Fluvoxamine was associated with significant improvement in negative symptoms ( Scale for the Assessment of Negative Symptoms ) compared to placebo . The combination was well tolerated . Fluvoxamine augmentation of antipsychotics is safe in chronic schizophrenic patients with mixed positive and negative symptoms and may ameliorate negative symptoms in such patients Following a 2-week placebo lead-in , schizophrenic patients were r and omly assigned to fluoxetine 20 mg/day or placebo added to depot neuroleptic for a 6-week , double blind trial . All patients had received a stable dose of depot neuroleptic for at least 6 months and did not meet criteria for depression . Serum sample s were obtained at baseline and at weeks 4 and 6 . Scores on the negative symptom subscale of the Brief Psychiatric Rating Scale ( BPRS ) were significantly lower at week 6 , controlling for baseline scores , in patients receiving fluoxetine ( n=20 ) compared to patients receiving placebo ( n=21 ) . Measures of psychosis , depression , global functioning and extrapyramidal symptoms ( EPS ) did not differ between groups at week 6 . Fluoxetine administration was associated with a mean 65 % increase in serum fluphenazine concentrations in 15 patients and a mean 20 % increase in serum haloperidol concentrations in three patients . The change in negative symptoms at week 6 did not correlate with serum concentrations of fluoxetine or norfluoxetine , but did inversely correlate withS-norfluoxetine , an active stereoisomer of fluoxetine . For these chronically ill patients , fluoxetine significantly improved negative symptoms and did not worsen EPS , despite causing substantial elevation in serum concentrations of neuroleptics Four patients with chronic schizophrenia were treated with a combination of fluvoxamine , haloperidol , and benztropine . The combination significantly impaired performance on tests of delayed recall memory and attentional function . Haloperidol concentrations in serum were monitored in three patients and were robustly elevated by fluvoxamine Forty-six schizophrenic or schizoaffective patients with operationally defined episodes of postpsychotic depression were assessed for previous histories of substance abuse . Thirty-five percent had histories of previous cannabis ( marijuana ) abuse . Additionally , 13 % had also abused cocaine , 13 % amphetamines , 11 % hallucinogens , 4 % sedatives , and 2 % opiates . Patients with histories of substance abuse were younger and showed higher index ratings on a subscale of endogenous depressive features . These findings are considered in the context of a possible self-medication hypothesis of substance abuse . A history of substance abuse did not appear to be a contraindication to a therapeutic trial of adjunctive imipramine ( Ciba Geigy Corp. , Summit , NJ ) for postpsychotic depression Eighty-seven predominantly withdrawn chronic male schizophrenics were r and omly assigned to one of three treatment groups . After a two-week course of placebo administration treatment was started with matching tablets containing either amitriptyline 25 mg.+perphenazine 4 mg . , perphenazine 4 mg . , or placebo . For the first five weeks of the trial the dose was one tablet t.i.d . , and for the second five weeks , 2 tablets t.i.d . Neither the nursing staff nor the doctors concerned knew which tablets were which . Wing Scale Form A ( completed by two psychiatrists independently ) and Form B ( filled in by a senior nurse ) yielded very similar results , rating the effectiveness of the three treatments as amitriptyline/perphenazine > perphenazine > Analysis of variance of overall improvement and of individual symptoms revealed that differences between doctors ' assessment s were insignificant . Patients taking amitriptyline/perphenazine showed a significant weight gain . Regular blood examination revealed no abnormalities . The withdrawn , inert hospitalized male schizophrenic constitutes a difficult problem to many workers in the psychiatric field . The encouraging fact emerged from this clinical trial that symptoms such as flattening and incongruity of affect , sometimes made worse by long-term administration of tranquilizing drugs ,
Output:
| The combination of antipsychotics and antidepressants may be effective in treating negative symptoms of schizophrenia , but the amount of information is currently too limited to allow any firm conclusions . |
MS212273 | ***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 High dose methotrexate ( HD-MTX ) , used in the treatment of children with acute lymphoblastic leukemia ( ALL ) , is moderately emetogenic . First generation 5-HT(3 ) receptor antagonists are effective prophylactic agents but require multiple administrations . Palonosetron has a half life of 36 - 42 hours and has higher affinity and selectivity to the 5-HT(3 ) receptor . Adult studies have demonstrated that palonosetron is both more effective and require fewer administrations than first generation 5-HT(3 ) receptor antagonists . The purpose of this study was to examine the effect of a single dose of palonosetron ( 5 µg/kg ) for the prevention of chemotherapy-induced nausea and vomiting in children 18 years of age with ALL treated with HD-MTX , 5 g/m(2 ) . PROCEDURE Between January 2010 and December 2010 , 138 courses , originating from 53 children , were included from four Danish Childhood Cancer Centers . Information regarding emetic episodes , rescue therapy , and nausea were recorded prospect ively on question naires . RESULTS Complete response ( no emesis and no rescue therapy ) was achieved in 84.1 % of courses during the acute ( 0 - 24 hours post-chemotherapy ) and in 60.1 % during the delayed phase ( 24 - 66 hours post-chemotherapy ) . 92.0 % of courses were free of emesis during the acute , and 86.2 % were free of emesis during the delayed phase . 76.8 % of courses were free of nausea during the acute , and 78.3 % were free of nausea during the delayed phase . CONCLUSIONS A single dose of palonosetron -- without concomitant corticosteroid -- was effective in preventing both acute and delayed phase CINV in majority of children with ALL treated with HD-MTX Palonosetron is a potent , selective 5-HT(3 ) receptor antagonist effective in the prevention of acute and delayed chemotherapy-induced nausea and vomiting . In practice , 5-HT(3 ) receptor antagonists , including palonosetron , are often coadministered with dexamethasone over approximately 15 minutes , although the approval of palonosetron was based on administration as a 30-second infusion . This open-label , r and omized , 2-way crossover trial compared the pharmacokinetics and safety of palonosetron 0.25 mg administered as a 15-minute 50-mL intravenous infusion with a 30-second 5-mL infusion . Aside from an anticipated 40 % decrease in maximum plasma concentration after a 15-minute infusion , the pharmacokinetics of palonosetron ( including area under the plasma concentration-time curve [ AUC ] , plasma elimination half-life , total body clearance , and apparent volume of distribution at steady state ) were similar for both treatments . Both treatments were well tolerated , with no significant changes in vital signs or electrocardiograms . Palonosetron infused over 15 minutes is well tolerated , with an AUC(0-infinity ) equivalent to a 30-second infusion Chemotherapy-induced nausea and vomiting is ranked among the worst side effects of chemotherapy . NEPA is an oral fixed-dose combination antiemetic under development , consisting of netupitant 300 mg , a highly selective NK1 receptor antagonist ( RA ) , and palonosetron 0.5 mg , a pharmacologically and clinical ly distinct 5-HT3 RA . Although palonosetron is not associated with relevant ECG effects , this study evaluated cardiovascular safety of netupitant in combination with palonosetron , as well as its tolerability . This r and omised , placebo- and positively controlled study in 197 subjects included 4 treatment groups : placebo , 200 mg netupitant + 0.5 mg palonosetron ( NEPA200/0.5 ) , 600 mg netupitant + 1.5 mg palonosetron ( NEPA600/1.5 , a supratherapeutic dose ) , and 400 mg moxifloxacin . Assessment s included a 24-h baseline ECG recording , followed by a single dose of treatment and ECG measurements for 2 days . Mean placebo-corrected time-averaged changes from baseline were similar in NEPA200/0.5 and NEPA600/1.5 groups primarily for individually heart rate-corrected QT interval ( QTcI : + 4.7 and + 3.6 ms , respectively ) and for heart rate ( HR : –3.3 bpm and –3.0 bpm ) , PR interval ( –0.4 ms and 0.2 ms ) , and QRS interval ( 1 ms and 0.5 ms ) . The time-matched analysis showed no upper confidence interval > 10 ms , with no suggestion of a QTc effect by pharmacokinetic-pharmacodynamic modeling for parent/metabolites . Moxifloxacin showed the expected placebo-corrected change from baseline ( + 8.4 ms time average ) and the expected profile to establish assay sensitivity . No new morphologic changes of clinical relevance were observed . Treatment-related adverse events were comparable among groups . This study showed that NEPA treatments produced no significant effects on QTcI , HR , PR interval , QRS interval , and cardiac morphology relative to placebo , even at supratherapeutic doses BACKGROUND Although currently available 5-hydroxytryptamine type 3 receptor ( 5-HT3 ) antagonists are effective , not all patients receiving these agents achieve adequate control of chemotherapy-induced nausea and vomiting ( CINV ) . Palonosetron , a potent and highly selective 5-HT3 antagonist with a strong affinity for 5-HT3 and a prolonged plasma elimination half-life , may provide a longer duration of action than other approved agents . PATIENTS AND METHODS One hundred and sixty-one patients were r and omly assigned to receive a single intravenous bolus dose of palonosetron ( 0.3 , 1 , 3 , 10 , 30 or 90 microg/kg ) before administration of highly emetogenic chemotherapy , with no pretreatment with corticosteroids . RESULTS The four highest doses of palonosetron were similarly effective during the first 24 h , producing clearly higher complete response ( CR ) ( no emesis , no rescue medication ) rates in the 3 , 10 , 30 and 90 microg/kg groups ( 46 % , 40 % , 50 % and 46 % , respectively ) than in the 0.3 - 1 microg/kg group ( 24 % ) of evaluable patients ( n = 148 ) . The 3 microg/kg dose was identified as the lowest effective dose . A single dose of palonosetron showed prolonged efficacy in preventing delayed emesis , with approximately one-third of patients who received palonosetron 10 or 30 microg/kg maintaining a CR throughout the 7-day period following chemotherapy administration . Dose-proportional increases in pharmacokinetic parameters and a long plasma half-life ( 43.7 - 128 h ) were observed . Palonosetron was well-tolerated , with no dose-response effect evident for the incidence or intensity of adverse events . CONCLUSIONS Palonosetron is an effective and well-tolerated agent for the prevention of CINV following highly emetogenic chemotherapy , with 3 and 10 microg/kg identified as the lowest effective palonosetron doses This study evaluated the safety and pharmacokinetics of consecutive multiple-day dosing of palonosetron . Sixteen healthy subjects received an intravenous bolus dose of palonosetron 0.25 mg ( n = 12 ) or placebo ( n = 4 ) daily for 3 consecutive days . Safety was evaluated throughout the study . Serial plasma sample s were collected on days 1 and 3 for pharmacokinetic determinations . Three days of dosing with palonosetron 0.25 mg was safe and well tolerated . There were no clinical ly significant changes from baseline in laboratory values , vital signs , physical examinations , or electrocardiogram intervals . Plasma palonosetron concentrations declined in a biphasic manner , measurable up to 168 hours after dosing on day 3 . Mean terminal phase elimination half-life after day 3 dosing was 42.8 hours . The 2.1-fold accumulation of palonosetron in plasma following 3 daily doses was predictable based on elimination half-life of approximately 40 hours , and the maximum plasma concentration remained below the maximum plasma concentration previously observed after a single , well-tolerated 0.75 mg intravenous bolus dose of palonosetron BACKGROUND Chemotherapy-induced nausea and vomiting ( CINV ) in children is a major side effect despite the use of combination antiemetic drugs . OBJECTIVE To compare the efficacy and safety profile of palonosetron , a second-generation 5-hydroxytryptamine-3 ( 5-HT3 ) receptor antagonist , with ondansetron in the prevention of CINV in children . METHODS A prospect i ve , r and omized , crossover study was conducted in patients aged 2 - 18 years . 160 chemotherapy cycles , consisting of chemotherapy drugs with moderate- and high-emetogenic potential , were studied . The study group received a single dose of intravenous ( IV ) palonosetron 5 mcg/kg , and the st and ard group received IV ondansetron 5 mg/m2 every 8 hours while receiving chemotherapy . The patients were observed for vomiting , use of rescue antiemetic medications , and nausea from Day 1 0 - 72 hours after completion of each chemotherapy cycle . All adverse events during the study period were recorded . RESULTS The overall percentage of patients with complete response ( CR ) in the palonosetron and ondansetron groups were 60 % and 56.2 % , respectively ( 𝑃 = .631 ) . The CR rates in the palonosetron and ondansetron groups were 75 % and 70 % , respectively , in the acute phase ( 𝑃 = .479 ) , and 68.8 % and 65 % , respectively , in the delayed phase ( 𝑃 = .614 ) . There was no statistically significant difference in the CR rates cross both groups . CONCLUSION A single dose of palonosetron is noninferior to ondansetron in the prevention of CINV in children and can be considered as an alternative antiemetic drug . There was no significant difference in adverse effects between the palonosetron and ondansetron group ABSTRACT Background : Palonosetron is a second-generation 5-HT3 receptor antagonist with a prolonged duration of action and higher receptor binding affinity than first-generation agents ( ondansetron , granisetron , and dolasetron ) . Aprepitant is a selective antagonist of substance P/neurokinin 1 that augments the benefit of 5-HT3 receptor antagonists in the prevention of chemotherapy-induced nausea and vomiting . Methods : This r and omized , open-label , two-way , crossover trial was design ed to evaluate the effect of oral aprepitant on the pharmacokinetics and safety of a single intravenous ( IV ) dose of palonosetron in 12 healthy subjects . Treatment A consisted of a single IV bolus dose of palonosetron 0.25 mg on day 1 . Treatment B added oral aprepitant 125 mg on day 1 ( 30 minutes prior to palonosetron ) and 80 mg on days 2 and 3 . Blood for pharmacokinetic evaluations was collected through 168 hours after palonosetron administration on days 1 and 15 ; safety was monitored through day 22 . Results : Mean plasma concentration-time plots for palonosetron were virtually identical for palonosetron administered alone or with concomitant aprepitant . The ratio of geometric least-square mean values ( with : without aprepitant ) for Cmax was 98.6 % ( 90 % confidence interval [ CI ] : 61.8–157 % ) , and for AUC0–∞ the ratio was 101 % ( 90 % CI : 85.6–119 % ) . With and without aprepitant coadministration , respectively , mean plasma elimination half-life was 40 hours and 43 hours ( difference : –3.0 hours ; p = 0.348 ) , mean total body clearance was 130 mL/min and 136 mL/min ( difference : –5.6 mL/min ; p = 0.735 ) , and mean volume of distribution at steady-state was 410.9 L and 442.3 L ( difference : –31.4 L ; p = 0.463 ) . Palonosetron alone and the palonosetron/aprepitant regimen were well tolerated . Conclusion : These results indicate no significant differences in pharmacokinetic parameters for palonosetron between the two treatments , and suggest that palonosetron can be safely coadministered with aprepitant with no alterations in the expected safety profile and no dosage adjustment necessary Antiemetic treatment compliance is important to prevent chemotherapy‐induced nausea and vomiting , a feared chemotherapy side effect . NEPA , a new or
Output:
| The recommendations were based on three systematic review s. Substantive changes were made to the guideline recommendations including the inclusion of palonosetron to the 5-HT3 antagonists recommended for children receiving highly emetogenic chemotherapy ( HEC ) and the recommendation of aprepitant for children 6 months of age or older receiving HEC . |
MS212274 | ***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: Allogeneic marrow transplantation can cure sickle cell disease ; however , HLA-matched donors are difficult to find , and the toxicities of myeloablative conditioning are prohibitive for most adults with this disease . We developed a nonmyeloablative bone marrow transplantation platform using related , including HLA-haploidentical , donors for patients with sickle cell disease . The regimen consisted of antithymocyte globulin , fludarabine , cyclophosphamide , and total body irradiation , and graft-versus-host disease prophylaxis with posttransplantation high-dose cyclophosphamide , mycophenolate mofetil , and tacrolimus or sirolimus . After screening 19 patients , we transplanted 17 , 14 from HLA-haploidentical and 3 from HLA-matched related donors . Eleven patients engrafted durably . With a median follow-up of 711 days ( minimal follow up 224 days ) , 10 patients are asymptomatic , and 6 patients are off immunosupression . Only 1 patient developed skin-only acute graft-versus-host disease that resolved without any therapy ; no mortality was seen . Nonmyeloablative conditioning with posttransplantation high-dose cyclophosphamide exp and s the donor pool , making marrow transplantation feasible for most patients with sickle cell disease , and is associated with a low risk of complications , even with haploidentical related donors . Graft failure , 43 % in haploidentical pairs , remains a major obstacle but may be acceptable in a fraction of patients if the majority can be cured without serious toxicities BACKGROUND The use of inhaled glucocorticoids for persistent asthma causes a temporary reduction in growth velocity in prepubertal children . The result ing decrease in attained height 1 to 4 years after the initiation of inhaled glucocorticoids is thought not to decrease attained adult height . METHODS We measured adult height in 943 of 1041 participants ( 90.6 % ) in the Childhood Asthma Management Program ; adult height was determined at a mean ( ±SD ) age of 24.9±2.7 years . Starting at the age of 5 to 13 years , the participants had been r and omly assigned to receive 400 μg of budesonide , 16 mg of nedocromil , or placebo daily for 4 to 6 years . We calculated differences in adult height for each active treatment group , as compared with placebo , using multiple linear regression with adjustment for demographic characteristics , asthma features , and height at trial entry . RESULTS Mean adult height was 1.2 cm lower ( 95 % confidence interval [ CI ] , -1.9 to -0.5 ) in the budesonide group than in the placebo group ( P=0.001 ) and was 0.2 cm lower ( 95 % CI , -0.9 to 0.5 ) in the nedocromil group than in the placebo group ( P=0.61 ) . A larger daily dose of inhaled glucocorticoid in the first 2 years was associated with a lower adult height ( -0.1 cm for each microgram per kilogram of body weight ) ( P=0.007 ) . The reduction in adult height in the budesonide group as compared with the placebo group was similar to that seen after 2 years of treatment ( -1.3 cm ; 95 % CI , -1.7 to -0.9 ) . During the first 2 years , decreased growth velocity in the budesonide group occurred primarily in prepubertal participants . CONCLUSIONS The initial decrease in attained height associated with the use of inhaled glucocorticoids in prepubertal children persisted as a reduction in adult height , although the decrease was not progressive or cumulative . ( Funded by the National Heart , Lung , and Blood Institute and the National Center for Research Re sources ; CAMP Clinical Trials.gov number , NCT00000575 . ) IMPORTANCE Myeloablative allogeneic hematopoietic stem cell transplantation ( HSCT ) is curative for children with severe sickle cell disease , but toxicity may be prohibitive for adults . Nonmyeloablative transplantation has been attempted with degrees of preparative regimen intensity , but graft rejection and graft-vs-host disease remain significant . OBJECTIVE To determine the efficacy , safety , and outcome on end-organ function with this low-intensity regimen for sickle cell phenotype with or without thalassemia . DESIGN , SETTING , AND PARTICIPANTS From July 16 , 2004 , to October 25 , 2013 , 30 patients aged 16 - 65 years with severe disease enrolled in this nonmyeloablative transplant study , consisting of alemtuzumab ( 1 mg/kg in divided doses ) , total-body irradiation ( 300 cGy ) , sirolimus , and infusion of unmanipulated filgrastim mobilized peripheral blood stem cells ( 5.5 - 31.7 × 10(6 ) cells/kg ) from human leukocyte antigen-matched siblings . MAIN OUTCOMES AND MEASURES The primary end point was treatment success at 1 year after the transplant , defined as a full donor-type hemoglobin for patients with sickle cell disease and transfusion independence for patients with thalassemia . The secondary end points were the level of donor leukocyte chimerism ; incidence of acute and chronic graft-vs-host disease ; and sickle cell-thalassemia disease-free survival , immunologic recovery , and changes in organ function , assessed by annual brain imaging , pulmonary function , echocardiographic image , and laboratory testing . RESULTS Twenty-nine patients survived a median 3.4 years ( range , 1 - 8.6 ) , with no nonrelapse mortality . One patient died from intracranial bleeding after relapse . As of October 25 , 2013 , 26 patients ( 87 % ) had long-term stable donor engraftment without acute or chronic graft-vs-host disease . The mean donor T-cell level was 48 % ( 95 % CI , 34%-62 % ) ; the myeloid chimerism levels , 86 % ( 95 % CI , 70%-100 % ) . Fifteen engrafted patients discontinued immunosuppression medication with continued stable donor chimerism and no graft-vs-host disease . The normalized hemoglobin and resolution of hemolysis among engrafted patients were accompanied by stabilization in brain imaging , a reduction of echocardiographic estimates of pulmonary pressure , and allowed for phlebotomy to reduce hepatic iron . The mean annual hospitalization rate was 3.23 ( 95 % CI , 1.83 - 4.63 ) the year before , 0.63 ( 95 % CI , 0.26 - 1.01 ) the first year after , 0.19 ( 95 % CI , 0 - 0.45 ) the second year after , and 0.11 ( 95 % CI , 0.04 - 0.19 ) the third year after transplant . For patients taking long-term narcotics , the mean use per week was 639 mg ( 95 % CI , 220 - 1058 ) of intravenous morphine-equivalent dose the week of their transplants and 140 mg ( 95 % CI , 56 - 225 ) 6 months after transplant . There were 38 serious adverse events : pain and related management , infections , abdominal events , and sirolimus related toxic effects . CONCLUSIONS AND RELEVANCE Among 30 patients with sickle cell phenotype with or without thalassemia who underwent nonmyeloablative allogeneic HSCT , the rate of stable mixed-donor chimerism was high and allowed for complete replacement with circulating donor red blood cells among engrafted participants . Further accrual and follow-up are required to assess longer-term clinical outcomes , adverse events , and transplant tolerance . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00061568 Prior studies of asthma in children with sickle cell disease ( SCD ) were based on reports of a doctor‐diagnosis of asthma with limited description of asthma features . Doctor‐diagnoses of asthma may represent asthma or wheezing unrelated to asthma . Objectives of this study were to determine if asthma characteristics are present in adults with a doctor‐diagnosis of asthma and /or wheezing , and to examine the relationship between doctor‐diagnosis of asthma , wheezing and SCD morbidity . This was an observational cohort study of 114 adults with SCD who completed respiratory symptom question naires and had serum IgE measurements . A subset of 79 participants completed pulmonary function testing . Survival analysis was based on a mean prospect i ve follow‐up of 28 months and data were censored at the time of death or loss to follow‐up . Adults reporting a doctor‐diagnosis of asthma ( N = 34 ) were more likely to have features of asthma including wheeze , eczema , family history of asthma , and an elevated IgE level ( all P < 0.05 ) . However , there was no difference in pain or ACS rate , lung function , or risk of death between adults with and without a doctor‐diagnosis of asthma . In contrast , adults who reported recurrent , severe episodes of wheezing ( N = 34 ) , regardless of asthma , had twice the rates of pain and ACS , decreased lung function and increased risk of death compared with adults without recurrent , severe wheezing . Asthma features were not associated with recurrent , severe wheezing . Our data suggest that wheezing in SCD may occur independently of asthma and is a marker of disease severity . Am . J. Hematol . 2011 . © 2011 Wiley‐Liss , Pain and acute chest syndrome ( ACS ) episodes are 2 of the most common causes of hospitalization in children with sickle cell anemia ( SCA ) . However , very few potentially modifiable risk factors for either condition have been identified . In this prospect i ve infant cohort study , we tested the hypothesis that asthma is associated with an increased incidence rate of pain and ACS episodes . An infant cohort was composed of 291 African American children with hemoglobin SS enrolled in the Cooperative Study for Sickle Cell Disease before age 6 months and followed beyond age 5 years . Asthma was defined by a physician diagnosis , an acute asthma event , or use of prescription asthma medications . The incidence rates of ACS and painful episodes were compared for children with and without asthma . A clinical diagnosis of asthma was made in 17 % of the cohort . Asthma was associated with more frequent ACS episodes ( 0.39 vs 0.20 events per patient year , P < .001 ) and painful episodes ( 1.39 vs 0.47 events per patient year , P < .001 ) . In conclusion , in children with SCA , asthma is associated with an increased incidence of sickle cell disease-related morbidity , including ACS and painful episodes An analysis of a prospect i ve cohort of individuals with sickle cell anemia ( SCA ) , enrolled from birth through adulthood , was conducted to determine if asthma is a risk factor for death in SCA . All-cause mortality was determined for participants after adjusting for known risk factors for death in SCA . The study included 1,963 individuals who were followed for 18,495 patient-years . After controlling for established risk factors , individuals with SCA and asthma had a more than two-fold higher risk of mortality ( hazard ratio 2.36 , 95 % CI 1.21 to 4.62 , p=0.01 ) . To summarize , asthma is a risk factor for death in SCA
Output:
| The presence of asthma or asthma symptom(recurrentwheezing ) , significantly increases the risk ofSCD-relatedmorbidity4 and mortality.5 - 7However , the guideline doesnotprovide anyapproach to screen and treat asthma orasthma-like symptoms . |
MS212275 | ***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 efficacy of an interactive self-help workbook in reducing distress , and improving quality of life ( QOL ) and coping for women recently diagnosed with breast cancer . DESIGN R and omised controlled trial comparing the use of the workbook and that of an information booklet . PARTICIPANTS AND SETTING 49 women with Stage 0 to II breast cancer diagnosed in the previous month and recruited from 1 February 2007 to 1 February 2008 , in two urban Australian public hospitals . MAIN OUTCOME MEASURES The primary outcome measures were depression , anxiety , and posttraumatic stress . Secondary outcomes included QOL , body image , and the coping styles helplessness/hopelessness , cognitive avoidance and anxious preoccupation . RESULTS After controlling for baseline levels , interactions at 3-month follow-up showed that participants in the workbook group had significantly lower levels of posttraumatic stress ( F[1,89 ] = 7.01 ; P = 0.01 ) , helplessness/hopelessness ( F [ 1,89 ] = 4.75 ; P = 0.03 ) , and cognitive avoidance ( F [ 1,89 ] = 4.95 ; P = 0.03 ) than those in the control ( information booklet ) group . However , women in the workbook group had significantly poorer body image than those in the control group ( F [ 1,89 ] = 6.43 ; P = 0.01 ) . At 6 months , only the body image interaction remained significant ( F [ 1,93 ] = 7.44 ; P = 0.01 ) . CONCLUSION These results suggest that a self-help workbook can be an effective , short-term intervention for improving posttraumatic stress , cognitive avoidance , and certain depressive symptoms in women recently diagnosed with breast cancer . However , issues related to body image need to be dealt with differently . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Background The p value obtained from a significance test provides no information about the magnitude or importance of the underlying phenomenon . Therefore , additional reporting of effect size is often recommended . Effect sizes are theoretically independent from sample size . Yet this may not hold true empirically : non-independence could indicate publication bias . Methods We investigate whether effect size is independent from sample size in psychological research . We r and omly sample d 1,000 psychological articles from all areas of psychological research . We extracted p values , effect sizes , and sample sizes of all empirical papers , and calculated the correlation between effect size and sample size , and investigated the distribution of p values . Results We found a negative correlation of r = −.45 [ 95 % CI : −.53 ; −.35 ] between effect size and sample size . In addition , we found an inordinately high number of p values just passing the boundary of significance . Additional data showed that neither implicit nor explicit power analysis could account for this pattern of findings . Conclusion The negative correlation between effect size and sample s size , and the biased distribution of p values indicate pervasive publication bias in the entire field of psychology Melanoma accounts for > 79 % of skin cancer‐related deaths , although it accounts for only 4 % of skin cancer incidence . Given the potential for lethality , it is likely that patients with melanoma may experience significant emotional distress . The current study was design ed to determine the effect of a cognitive‐behavioral intervention on distress and health‐related quality of life ( HRQOL ) in patients with melanoma who had medium‐to‐high distress OBJECTIVE The aim is to evaluate the effectiveness of a manualized 12-week supportive-expressive group therapy program among primary breast cancer patients treated in community setting s , to determine whether highly distressed patients were most likely to benefit and whether therapist 's training or experience was related to outcome . METHOD Three hundred and fifty-three women within one year of diagnosis with primary breast cancer were r and omly assigned to receive supportive-expressive group therapy or to an education control condition . Participants were recruited from two academic centers and nine oncology practice s , which were members of NCI 's Community Clinical Oncology Program ( CCOP ) and were followed over 2 years . RESULTS A 2x2x19 analysis of variance was conducted with main effects of treatment condition , cohort , and baseline distress and their interactions . There was no main effect for treatment condition after removing one subject with an extreme score . Highly distressed women did not derive a greater benefit from treatment . Therapist training and psychotherapy experience were not associated with a treatment effect . CONCLUSIONS This study provides no evidence of reduction in distress as the result of a brief supportive-expressive intervention for women with primary breast cancer . Future studies might productively focus on women with higher initial levels of distress BACKGROUND As cancer mortality rates improve in Singapore , there is an increasing need to improve the transition to posttreatment survivorship care . This study aim ed to evaluate the effectiveness of a psychoeducation group ( PEG ) intervention program compared with usual care to reduce distress for physical symptom and psychological aspects in Asian breast cancer survivors who have completed adjuvant chemotherapy . METHODS This was a r and omized , controlled trial comprising 72 Asian early stage breast cancer survivors who were r and omized into the PEG ( n = 34 ) or the control ( n = 38 ) arm . The participants in the PEG arm underwent a weekly multidisciplinary PEG program delivered in a group format over 3 weeks coupled with cultural adaptation . Both arms were assessed at baseline and 2 months after intervention using the Rotterdam Symptom Checklist , Beck Anxiety Inventory , and EORTC QLQ-C30 . A satisfaction question naire was also conducted among those survivors who have participated in the PEG program . Effective sizes were calculated using Cohen d. RESULTS The mean age ± SD of all participants was 53.0 ± 8.9 years , with the majority being Chinese ( 84.7 % ) and Malay ( 6.9 % ) , and clinical characteristics were well balanced in both arms . Compared to the control arm , the PEG arm showed a significantly greater reduction in physical symptom distress ( d = 0.76 , P = .01 ) and fatigue ( d = 0.49 , P = .04 ) . The 82.4 % of the participants in the intervention group responded to the satisfaction question naire , and the majority ( 92.9 % ) agreed that the overall duration of the PEG intervention program was appropriate . CONCLUSIONS A culturally adapted PEG program was effective in reducing physical symptom distress in Asian breast cancer survivors . ( Clinical Trials.gov : NCT02600299 ) Background Web and mobile technologies appear to hold promise for delivering evidence -informed and evidence -based intervention to cancer survivors and others living with trauma and other psychological concerns . Health-space.net was developed as a comprehensive online social networking and coping skills training program for cancer survivors living with distress . Purpose The purpose of this study was to evaluate the effects of a 12-week social networking intervention on distress , depression , anxiety , vigor , and fatigue in cancer survivors reporting high levels of cancer-related distress . Methods We recruited 347 participants from a local cancer registry and internet , and all were r and omized to either a 12-week waiting list control group or to immediate access to the intervention . Intervention participants received secure access to the study website , which provided extensive social networking capabilities and coping skills training exercises facilitated by a professional facilitator . Results Across time , the prevalence of clinical ly significant depression symptoms declined from 67 to 34 % in both conditions . The health-space.net intervention had greater declines in fatigue than the waitlist control group , but the intervention did not improve outcomes for depression , trauma-related anxiety symptoms , or overall mood disturbance . For those with more severe levels of anxiety at baseline , greater engagement with the intervention was associated with higher levels of symptom reduction over time . Conclusions The intervention result ed in small but significant effects on fatigue but not other primary or secondary outcomes . Results suggest that this social networking intervention may be most effective for those who have distress that is not associated with high levels of anxiety symptoms or very poor overall psychological functioning . Trial Registration NumberThe trial was registered with the Clinical Trials.gov data base ( Clinical Trials.gov # NCT01976949 ) OBJECTIVE To compare in a multicenter r and omized controlled trial the benefits in terms of anxiety regulation of a 15-session single-component group intervention ( SGI ) based on support with those of a 15-session multiple-component structured manualized group intervention ( MGI ) combining support with cognitive-behavioral and hypnosis components . METHODS Patients with nonmetastatic breast cancer were r and omly assigned at the beginning of the survivorship period to the SGI ( n = 83 ) or MGI ( n = 87 ) . Anxiety regulation was assessed , before and after group interventions , through an anxiety regulation task design ed to assess their ability to regulate anxiety psychologically ( anxiety levels ) and physiologically ( heart rates ) . Question naires were used to assess psychological distress , everyday anxiety regulation , and fear of recurrence . Group allocation was computer generated and concealed till baseline completion . RESULTS Compared with patients in the SGI group ( n = 77 ) , patients attending the MGI group ( n = 82 ) showed significantly reduced anxiety after a self-relaxation exercise ( P = .006 ) and after exposure to anxiety triggers ( P = .013 ) and reduced heart rates at different time points throughout the task ( P = .001 to P = .047 ) . The MGI participants also reported better everyday anxiety regulation ( P = .005 ) , greater use of fear of recurrence-related coping strategies ( P = .022 ) , and greater reduction in fear of recurrence-related psychological distress ( P = .017 ) compared with the SGI group . CONCLUSIONS This study shows that an MGI combining support with cognitive-behavioral techniques and hypnosis is more effective than an SGI based only on support in improving anxiety regulation in patients with breast cancer To compare the effectiveness of individual support , group rehabilitation and a combination of the two in improving health-related quality of life ( HRQOL ) and psychological well-being in cancer patients during 24 months after diagnosis , as compared with st and ard care ( SC ) . Furthermore , to compare the study sample and a r and om sample of the Swedish population with regard to HRQOL . A total of 481 consecutive patients , newly diagnosed with cancer , were r and omly assigned to one of the four alternatives . Data on HRQOL and psychological well-being were collected at baseline and after 3 , 6 , 12 and 24 months . The interventions did not improve HRQOL or psychological well-being , as compared with SC . At 3 months , the study sample reported an HRQOL comparable with the normal population . Many cancer patients are able to manage their cancer-related concerns with the support available from SC . However , it is reasonable to assume that the findings suffer from a lack of data from especially vulnerable patients and a possible Hawthorne effect . It can not be concluded that cancer patients have no need for additional psychosocial interventions . Future projects should include screening and target interventions for those at risk for significant and prolonged psychological distress BACKGROUND The aim of this study was to assess the efficacy of meaning-centered group psychotherapy for cancer survivors ( MCGP-CS ) to improve personal meaning , compared with supportive group psychotherapy ( SGP ) and care as usual ( CAU ) . METHOD A total of 170 cancer survivors were r and omly assigned to one of the three study arms : MCGP-CS ( n = 57 ) ; SGP ( n = 56 ) ; CAU ( n = 57 ) . The primary outcome measure was the Personal Meaning Profile ( PMP ; total score ) . Secondary outcome measures were subscales of the PMP , psychological well-being ( Scales of Psychological Well-being ; SPWB ) , post-traumatic growth ( Posttraumatic Growth Inventory ) , Mental Adjustment to Cancer ( MAC ) , optimism ( Life Orientation Test-Revised ) , hopelessness ( Beck 's Hopelessness Scale ) , psychological distress ( anxiety and depression , Hospital Anxiety and Depression Scale ; HADS ) and quality of life ( European Organization for Research and Treatment of Cancer Quality of Life Question naire ; EORTC QLQ-C30 ) . Outcome measures were assessed before r and omization , post-intervention , and after 3 and 6 months of follow-up ( FU ) . RESULTS Linear mixed model analyses ( intention-to-treat ) showed significant differences between MCGP-CS , SGP and CAU on the total PMP score , and on (sub)scales of the PMP , SPWB , MAC and HADS . Post-hoc analyses showed significantly stronger treatment effects of MCGP-CS compared with CAU on personal meaning ( d = 0.81 ) , goal -orientedness ( d = 1.07 ) , positive relations ( d = 0.59 ) , purpose in life ( d = 0.69 ) ; fighting spirit ( d = 0.61 ) ( post-intervention ) and helpless/hopeless ( d = -0.87 ) ( 3 months FU ) ; and distress ( d = -0.6 ) and depression ( d = -0.38 ) ( 6 months FU ) . Significantly stronger effects of MCGP-CS compared with SGP were found on personal growth ( d = 0.57 ) ( 3 months FU ) and environmental mastery ( d = 0.66 ) ( 6 months FU ) . CONCLUSIONS MCGP-CS is an effective intervention for cancer survivors to improve personal meaning , psychological well-being and mental adjustment to cancer in the short term , and to reduce psychological distress in the long run INTRODUCTION Gaining regular insight into the nature and severity of distress by a psychosocial nurse coupled with referral to psychosocial and /or paramed
Output:
| Low psychological distress at baseline and non evidence -based interventions were the main factors identified for low effectiveness . |
MS212276 | ***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 Cognitive training ( CT ) offers a potential approach for dementia prevention and maintenance of cognitive function in older adults . Online delivery provides a cost-effective means of implementing CT compared with in-person interventions , with the potential of providing an effective public health intervention for risk reduction . METHODS A double-blind 6-month online r and omized controlled trial in adults older than 50 r and omized to General CT , Reasoning CT , or control . The primary outcome was instrumental activities of daily living ( IADL ) in adults older than 60 . Secondary outcomes were reasoning , verbal short-term memory , spatial working memory , verbal learning ( VL ) , and digit vigilance in adults older than 50 . Secondary analyses were performed with a group defined as showing age-associated impairment in reasoning according to baseline scores in this domain . RESULTS A total of 2912 adults older than 60 ( 6742 > 50 ) participated . General and reasoning packages conferred benefit to IADL ( P = .008 , P = .011 ) , reasoning ( P < 0.0001 , P < .0001 ) , and VL ( P = .007 , P = .008 ) at 6 months . Benefit in reasoning was evident from 6 weeks . Other benefits developed over 6 months . Analysis of participants with age-associated impairment also showed the same pattern of benefit . A clear dose-response effect was seen . CONCLUSIONS Online CT confers significant benefit to cognition and function in older adults , with benefit favoring the Reasoning package . Scale of benefit is comparable with in-person training , indicating its potential as a public health intervention . Impact on the group with age-associated impairment indicates a particular sensitivity to this at-risk group , which merits further investigation BACKGROUND Home-based computerised cognitive training ( CCT ) is ineffective at enhancing global cognition , a key marker of cognitive ageing . OBJECTIVES To test the effectiveness of supervised , group-based , multidomain CCT on global cognition in older adults and to characterise the dose-response relationship during and after training . DESIGN A r and omised , double-blind , longitudinal , active-controlled trial . SETTING Community-based training centre in Sydney , Australia Participants : Eighty nondemented community-dwelling older adults ( mean age = 72.1 , 68.8 % females ) with multiple dementia risk factors but no major neuropsychiatric or sensory disorder . Of the 80 participants admitted to the study , 65 completed post-training assessment and 55 were followed up one year after training cessation . INTERVENTIONS Thirty-six group-based sessions over three months of either CCT targeting memory , speed , attention , language and reasoning tasks , or active control training comprising audiovisual educational exercises . MEASUREMENTS Primary outcome was change from baseline in global cognition as defined by a composite score of memory , speed and executive function . Secondary outcome was 15-month change in Bayer Activities of Daily Living from baseline to one year post-training . RESULTS Intention-to-treat analyses revealed significant effects on global cognition in the cognitive training group compared to active control after three weeks of training ( ES = 0.33 , P=.039 ) that increased after 3 months of training ( ES = 0.49 , P=.003 ) and persisted three months after training cessation ( ES = 0.30 , P=0.023 ) . Significant and durable improvements were also noted in memory and processing speed . Dose-response characteristics differed among cognitive domains . Training effects waned gradually but residual gains were noted twelve months post-training . No significant effects on activities of daily living were noted and there were no adverse effects . CONCLUSIONS In older adults with multiple dementia risk factors , group-based CCT is a safe and effective intervention for enhancing overall cognition , memory and processing speed . Dose-response relationships vary for each cognitive domain , vital information for clinical and community implementation and further trial design Introduction Cognitive training improves cognitive performance and delays functional impairment , but its effects on dementia are not known . We examined whether three different types of cognitive training lowered the risk of dementia across 10 years of follow-up relative to control and if greater number of training sessions attended was associated with lower dementia risk . Methods The Advanced Cognitive Training in Vital Elderly ( NCT00298558 ) study was a r and omized controlled trial ( N = 2802 ) among initially healthy older adults , which examined the efficacy of three cognitive training programs ( memory , reasoning , or speed of processing ) relative to a no-contact control condition . Up to 10 training sessions were delivered over 6 weeks with up to four sessions of booster training delivered at 11 months and a second set of up to four booster sessions at 35 months . Outcome assessment s were taken immediately after intervention and at intervals over 10 years . Dementia was defined using a combination of interview- and performance-based methods . Results A total of 260 cases of dementia were identified during the follow-up . Speed training result ed in reduced risk of dementia ( hazard ratio [ HR ] 0.71 , 95 % confidence interval [ CI ] 0.50–0.998 , P = .049 ) compared to control , but memory and reasoning training did not ( HR 0.79 , 95 % CI 0.57–1.11 , P = .177 and HR 0.79 , 95 % CI 0.56–1.10 , P = .163 , respectively ) . Each additional speed training session was associated with a 10 % lower hazard for dementia ( unadjusted HR , 0.90 ; 95 % CI , 0.85–0.95 , P < .001 ) . Discussion Initially , healthy older adults r and omized to speed of processing cognitive training had a 29 % reduction in their risk of dementia after 10 years of follow-up compared to the untreated control group BACKGROUND / OBJECTIVES There is no consensus on the efficacy of cognitive training in persons with mild cognitive impairment ( MCI ) because of the paucity of well- design ed r and omized controlled trials . The objective was to assess the effect of memory training on the cognitive functioning of persons with MCI and its durability and to evaluate whether this effect generalizes to daily life and whether positive effects could be obtained from psychosocial intervention . DESIGN Single-blind r and omized controlled trial . SETTING Research centers of the Institut Universitaire de Gériatrie de Montréal and Institut Universitaire en Santé Mentale de Québec . PARTICIPANTS Older adults meeting criteria for amnestic MCI ( N = 145 ) . INTERVENTION Participants were r and omized to cognitive training , a psychosocial intervention , or a no-contact control condition . Interventions were provided in small groups in eight 2-hour sessions . MEASUREMENT Outcome measures were immediate and delayed composite performance memory scores , psychological health ( depression , anxiety , well-being ) , and generalization effects of the intervention ( strategy use in everyday life , difficulties in complex activities of daily living , memory complaints ) . Testing was administered before training and immediately , 3 months , and 6 months after training . RESULTS Participants in the cognitive training condition improved on the delayed composite memory score and on strategy use in everyday life . Improvement was maintained at the 3- and 6-month follow-up assessment s. Participants in the psychosocial and no-contact conditions did not show any significant improvement . CONCLUSION Cognitive training improves the memory of persons with amnestic MCI . The effect persists over a 6-month period , and learned strategies are used in everyday life . Cognitive training is a valid way to promote cognition in MCI The purpose of the present investigation was to examine the impact of speed of processing training on the cognitive and everyday abilities of older adults with initial processing speed or processing difficulty . Participants were r and omized to either a speed of processing intervention or a social- and computer-contact control group . Results indicate that speed of processing training not only improves processing speed , as indicated by performance on the Useful Field of View test ( UFOV ® ) , but also transfers to certain everyday functions , as indicated by improved performance on Timed Instrumental Activities of Daily Living ( Timed IADL ) . Transfer of speed of processing training to other cognitive domains was not evident . This study provides additional evidence that speed of processing training has the potential to enhance everyday functions that maintain independence and quality of life , particularly when the training is targeted toward individuals who most need it . Further study is needed to learn about the long-term effects of such training in relation to everyday abilities CONTEXT Cognitive function in older adults is related to independent living and need for care . However , few studies have addressed whether improving cognitive functions might have short- or long-term effects on activities related to living independently . OBJECTIVE To evaluate whether 3 cognitive training interventions improve mental abilities and daily functioning in older , independent-living adults . DESIGN R and omized , controlled , single-blind trial with recruitment conducted from March 1998 to October 1999 and 2-year follow-up through December 2001 . SETTING AND PARTICIPANTS Volunteer sample of 2832 persons aged 65 to 94 years recruited from senior housing , community centers , and hospital/clinics in 6 metropolitan areas in the United States . INTERVENTIONS Participants were r and omly assigned to 1 of 4 groups : 10-session group training for memory ( verbal episodic memory ; n = 711 ) , or reasoning ( ability to solve problems that follow a serial pattern ; n = 705 ) , or speed of processing ( visual search and identification ; n = 712 ) ; or a no-contact control group ( n = 704 ) . For the 3 treatment groups , 4-session booster training was offered to a 60 % r and om sample 11 months later . MAIN OUTCOME MEASURES Cognitive function and cognitively dem and ing everyday functioning . RESULTS Thirty participants were incorrectly r and omized and were excluded from the analysis . Each intervention improved the targeted cognitive ability compared with baseline , durable to 2 years ( P<.001 for all ) . Eighty-seven percent of speed- , 74 % of reasoning- , and 26 % of memory-trained participants demonstrated reliable cognitive improvement immediately after the intervention period . Booster training enhanced training gains in speed ( P<.001 ) and reasoning ( P<.001 ) interventions ( speed booster , 92 % ; no booster , 68 % ; reasoning booster , 72 % ; no booster , 49 % ) , which were maintained at 2-year follow-up ( P<.001 for both ) . No training effects on everyday functioning were detected at 2 years . CONCLUSIONS Results support the effectiveness and durability of the cognitive training interventions in improving targeted cognitive abilities . Training effects were of a magnitude equivalent to the amount of decline expected in elderly persons without dementia over 7- to 14-year intervals . Because of minimal functional decline across all groups , longer follow-up is likely required to observe training effects on everyday function We investigated the potential benefits of a novel cognitive-training protocol and an aerobic exercise intervention , both individually and in concert , on older adults ' performances in laboratory simulations of select real-world tasks . The cognitive training focused on a range of cognitive processes , including attentional coordination , prospect i ve memory , and retrospective-memory retrieval , processes that are likely involved in many everyday tasks , and that decline with age . Primary outcome measures were 3 laboratory tasks that simulated everyday activities : Cooking Breakfast , Virtual Week , and Memory for Health Information . Two months of cognitive training improved older adults ' performance on prospect ive-memory tasks embedded in Virtual Week . Cognitive training , either alone or in combination with 6 months of aerobic exercise , did not significantly improve Cooking Breakfast or Memory for Health Information . Although gains in aerobic power were comparable with previous reports , aerobic exercise did not produce improvements for the primary outcome measures . Discussion focuses on the possibility that cognitive-training programs that include explicit strategy instruction and varied practice context s may confer gains to older adults for performance on cognitively challenging everyday tasks OBJECTIVES To determine the effects of cognitive training on cognitive abilities and everyday function over 10 years . DESIGN Ten-year follow-up of a r and omized , controlled single-blind trial ( Advanced Cognitive Training for Independent and Vital Elderly ( ACTIVE ) ) with three intervention groups and a no-contact control group . SETTING Six U.S. cities . PARTICIPANTS A volunteer sample of 2,832 persons ( mean baseline age 73.6 ; 26 % African American ) living independently . INTERVENTION Ten training sessions for memory , reasoning , or speed of processing ; four sessions of booster training 11 and 35 months after initial training . MEASUREMENTS Objective ly measured cognitive abilities and self-reported and performance-based measures of everyday function . RESULTS Participants in each intervention group reported less difficulty with instrumental activities of daily living ( IADLs ) ( memory : effect size = 0.48 , 99 % confidence interval ( CI ) = 0.12 - 0.84 ; reasoning : effect size = 0.38 , 99 % CI = 0.02 - 0.74 ; speed of processing : effect size = 0.36 , 99 % CI = 0.01 - 0.72 ) . At a mean age of 82 , approximately 60 % of trained participants , versus 50 % of controls ( P < .05 ) , were at or above their baseline level of self-reported IADL function at 10 years . The reasoning and speed-of-processing interventions maintained their effects on their targeted cognitive abilities at 10 years ( reasoning : effect size = 0.23 , 99 % CI = 0.09 - 0.38 ; speed of processing : effect size = 0.66 , 99 % CI =
Output:
| While variation in study protocol , outcome measurement , and effect size reporting precluded further inferential statistical analysis , our review found a sizable number of studies showing improvement in IADL .
Cognitive training may have some benefit in improving IADL function in older adults without major neurocognitive disorder . |
MS212277 | ***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 . Studies have shown decreases in N30 somatosensory evoked potential ( SEP ) peak amplitudes following spinal manipulation ( SM ) of dysfunctional segments in sub clinical pain ( SCP ) population s. This study sought to verify these findings and to investigate underlying brain sources that may be responsible for such changes . Methods . Nineteen SCP volunteers attended two experimental sessions , SM and control in r and om order . SEPs from 62-channel EEG cap were recorded following median nerve stimulation ( 1000 stimuli at 2.3 Hz ) before and after either intervention . Peak-to-peak amplitude and latency analysis was completed for different SEPs peak . Dipolar models of underlying brain sources were built by using the brain electrical source analysis . Two-way repeated measures ANOVA was used to assessed differences in N30 amplitudes , dipole locations , and dipole strengths . Results . SM decreased the N30 amplitude by 16.9 ± 31.3 % ( P = 0.02 ) , while no differences were seen following the control intervention ( P = 0.4 ) . Brain source modeling revealed a 4- source model but only the prefrontal source showed reduced activity by 20.2 ± 12.2 % ( P = 0.03 ) following SM . Conclusion . A single session of spinal manipulation of dysfunctional segments in sub clinical pain patients alters somatosensory processing at the cortical level , particularly within the prefrontal cortex OBJECTIVE The purpose of this study was to determine if high-velocity , low-amplitude spinal manipulation ( SM ) altered the effects of corticospinal excitability on motoneuron activity innervating the paraspinal muscles . In a previous study using transcranial magnetic stimulation ( TMS ) , augmentation of motor-evoked potentials ( MEPs ) from the gastrocnemius muscle after lumbar SM was reported . To date , there is no known report of the effect of SM on paraspinal muscle excitability . METHODS The experimental design was a prospect i ve physiologic evaluation of the effects of SM on corticospinal excitability in asymptomatic subjects . The TMS-induced MEPs were recorded from relaxed lumbar erector spinae muscles of 72 asymptomatic subjects . The MEP amplitudes were evaluated pre-SM and post-SM or conditions involving prethrust positioning and joint loading or control . RESULTS There was a transient increase in MEP amplitudes from the paraspinal muscles as a consequence of lumbar SM ( F([6,414 ] ) = 8.49 ; P < .05 ) without concomitant changes after prethrust positioning and joint loading or in control subjects ( P > .05 ) . These data findings were substantiated by a significant condition x time interaction term ( F([12,414 ] ) = 2.28 ; P < .05 ) . CONCLUSIONS These data suggest that there is a postsynaptic facilitation of alpha motoneurons and /or corticomotoneurons innervating paraspinal muscles as a consequence of SM . It appears that SM may offer unique sensory input to the excitability of the motor system as compared to prethrust positioning and joint loading and control conditions Purpose The primary purpose of this study was to investigate whether a single session of spinal manipulation ( SM ) increases strength and cortical drive in the lower limb ( soleus muscle ) of elite Taekwondo athletes . Methods Soleus-evoked V-waves , H-reflex and maximum voluntary contraction ( MVC ) of the plantar flexors were recorded from 11 elite Taekwondo athletes using a r and omized controlled crossover design . Interventions were either SM or passive movement control . Outcomes were assessed at pre-intervention and at three post-intervention time periods ( immediate post , post 30 min and post 60 min ) . A multifactorial repeated measures ANOVA was conducted to assess within and between group differences . Time and session were used as factors . A post hoc analysis was carried out , when an interactive effect was present . Significance was set at p ≤ 0.05 . Results SM increased MVC force [ F(3,30 ) = 5.95 , p < 0.01 ] , and V-waves [ F(3,30 ) = 4.25 , p = 0.01 ] over time compared to the control intervention . Between group differences were significant for all time periods ( p < 0.05 ) except for the post60 force measurements ( p = 0.07 ) . Conclusion A single session of SM increased muscle strength and corticospinal excitability to ankle plantar flexor muscles in elite Taekwondo athletes . The increased MVC force lasted for 30 min and the corticospinal excitability increase persisted for at least 60 min Significance Functional MRI ( fMRI ) is 25 years old , yet surprisingly its most common statistical methods have not been vali date d using real data . Here , we used resting-state fMRI data from 499 healthy controls to conduct 3 million task group analyses . Using this null data with different experimental design s , we estimate the incidence of significant results . In theory , we should find 5 % false positives ( for a significance threshold of 5 % ) , but instead we found that the most common software packages for fMRI analysis ( SPM , FSL , AFNI ) can result in false-positive rates of up to 70 % . These results question the validity of a number of fMRI studies and may have a large impact on the interpretation of weakly significant neuroimaging results . The most widely used task functional magnetic resonance imaging ( fMRI ) analyses use parametric statistical methods that depend on a variety of assumptions . In this work , we use real resting-state data and a total of 3 million r and om task group analyses to compute empirical familywise error rates for the fMRI software packages SPM , FSL , and AFNI , as well as a nonparametric permutation method . For a nominal familywise error rate of 5 % , the parametric statistical methods are shown to be conservative for voxelwise inference and invalid for clusterwise inference . Our results suggest that the principal cause of the invalid cluster inferences is spatial autocorrelation functions that do not follow the assumed Gaussian shape . By comparison , the nonparametric permutation test is found to produce nominal results for voxelwise as well as clusterwise inference . These findings speak to the need of validating the statistical methods being used in the field of neuroimaging Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials Background This systematic review up date d and extended the " UK evidence report " by Bronfort et al. ( Chiropr Osteopath 18:3 , 2010 ) with respect to conditions/ interventions that received an ' inconclusive ’ or ' negative ’ evidence rating or were not covered in the report . Methods A literature search of more than 10 general medical and specialised data bases was conducted in August 2011 and up date d in March 2013 . Systematic review s , primary comparative studies and qualitative studies of patients with musculoskeletal or non-musculoskeletal conditions treated with manual therapy and reporting clinical outcomes were included . Study quality was assessed using st and ardised instruments , studies were summarised , and the results were compared against the evidence ratings of Bronfort . These were either confirmed , up date d , or new categories not assessed by Bronfort were added . Results 25,539 records were found ; 178 new and additional studies were identified , of which 72 were systematic review s , 96 were r and omised controlled trials , and 10 were non-r and omised primary studies . Most ' inconclusive ’ or ' moderate ’ evidence ratings of the UK evidence report were confirmed . Evidence ratings changed in a positive direction from inconclusive to moderate evidence ratings in only three cases ( manipulation/mobilisation [ with exercise ] for rotator cuff disorder ; spinal mobilisation for cervicogenic headache ; and mobilisation for miscellaneous headache ) . In addition , evidence was identified on a large number of non-musculoskeletal conditions not previously considered ; most of this evidence was rated as inconclusive . Conclusions Overall , there was limited high quality evidence for the effectiveness of manual therapy . Most review ed evidence was of low to moderate quality and inconsistent due to substantial method ological and clinical diversity . Areas requiring further research are highlighted Background In r and omised trials , rather than comparing r and omised groups directly some research ers carry out a significance test comparing a baseline with a final measurement separately in each group . Methods We give several examples where this has been done . We use simulation to demonstrate that the procedure is invalid and also show this algebraically . Results This approach is biased and invalid , producing conclusions which are , potentially , highly misleading . The actual alpha level of this procedure can be as high as 0.50 for two groups and 0.75 for three . Conclusions R and omised groups should be compared directly by two- sample methods and separate tests against baseline are highly misleading OBJECTIVE The aim of the study was to examine the effects of a high-velocity , low-amplitude ( HVLA ) manipulation to the lumbosacral joint on corticospinal excitability , as measured by motor evoked potentials ( MEPs ) using transcranial magnetic stimulation , and spinal reflex excitability , as measured by the Hoffman reflex ( H-reflex ) . METHODS In a r and omized , controlled , crossover design , 14 asymptomatic volunteers ( mean age , 23 ± 5.4 years ; 10 men ; 4 women ) were measured for MEPs and H-reflexes immediately before and after a r and omly allocated intervention . The interventions consisted of HVLA applied bilaterally to the lumbosacral joint and a control intervention . Participants returned a week later , and the same procedures were performed using the other intervention . Data for H-reflex and MEP amplitudes were normalized to the M-wave maximum amplitude and analyzed using 2-way analysis of variance with repeated measures . RESULTS A significant interaction of treatment by time was found for MEP ( F(1,13 ) = 4.87 , P = .04 ) , and post hoc analyses showed that the MEP/M-wave maximum ratio decreased significantly in the HVLA treatment ( P = .02 ; effect size , 0.68 ) . For H-reflex , there was a significant effect of time ( F(1,13 ) = 8.186 , P = .01 ) and treatment and time interaction ( F(1,13 ) = 9.05 , P = .01 ) , with post hoc analyses showing that H-reflexes were significantly reduced after the HVLA manipulation ( P = .004 ; effect size , 0.94 ) . There were no significant changes in MEP latency or silent period duration . CONCLUSION An HVLA manipulation applied to the lumbosacral joint produced a significant decrease in corticospinal and spinal reflex excitability , and no significant change occurred after the control intervention . The changes in H-reflexes were larger than those in MEPs , suggesting a greater degree of inhibition at the level of the spinal cord BACKGROUND The physiologic mechanism by which spinal manipulation may reduce pain and muscular spasm is not fully understood . One such mechanistic theory proposed is that spinal manipulation may intervene in the cycle of pain and spasm by affecting the resting excitability of the motoneuron pool in the spinal cord . Previous data from our laboratory indicate that spinal manipulation leads to attenuation of the excitability of the motor neuron pool when assessed by means of peripheral nerve Ia-afferent stimulation ( Hoffmann reflex ) . OBJECTIVE The purpose of this study was to determine the effects of lumbar spinal manipulation on the excitability of the motor neuron pool as assessed by means of transcranial magnetic stimulation . METHODS Motor-evoked potentials were recorded subsequent to transcranial magnetic stimulation . The motor-evoked potential peak-to-peak amplitudes in the right gastrocnemius muscle of healthy volunteers ( n = 24 ) were measured before and after homolateral L5-S1 spinal manipulation ( experimental group ) or side-posture positioning with no manipulative thrust applied ( control group ) .
Output:
| Conclusion The available evidence suggests that changes occur in ‘ brain function ’ in response to spinal manipulation but are inconsistent across and - sometimes - within studies .
Conclusion La littérature scientifique suggère que des changements neurophysiologiques surviennent au niveau du cerveau en réponse à la manipulation vertébrale mais , de façon inconsistante .
Ainsi , il est prématuré d’attribuer à la manipulation vertébrale des bénéfices cliniques via un effet sur le cerveau |
MS212278 | ***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 recent studies have found that moderate intensity exercise is an effective intervention strategy for preventing falls in older people . However , research is required to determine whether supervised group exercise programmes , conducted in community setting s with at-risk older people referred by their health care practitioner are also effective in improving physical functioning and preventing falls in this group . OBJECTIVES to determine whether participation in a weekly group exercise programme with ancillary home exercises over one year improves balance , muscle strength , reaction time , physical functioning , health status and prevents falls in at-risk community-dwelling older people . METHODS the sample comprised 163 people aged over 65 years identified as at risk of falling using a st and ardised assessment screen by their general practitioner or hospital-based physiotherapist , residing in South Western Sydney , Australia . Subjects were r and omised into either an exercise intervention group or a control group . Physical performance and general health measures were assessed at baseline and repeated 6-months into the trial . Falls were measured over a 12-month follow-up period using monthly postal surveys . RESULTS at baseline both groups were well matched in their physical performance , health and activity levels . The intervention subjects attended a median of 23 exercise classes over the year , and most undertook the home exercise sessions at least weekly . At retest , the exercise group performed significantly better than the controls in three of six balance measures ; postural sway on the floor with eyes open and eyes closed and coordinated stability . The groups did not differ at retest in measures of strength , reaction time and walking speed or on Short-Form 36 , Physical Activity Scale for the Elderly or fear of falling scales . Within the 12-month trial period , the rate of falls in the intervention group was 40 % lower than that of the control group ( IRR=0.60 , 95 % CI 0.36 - 0.99 ) . CONCLUSIONS these findings indicate that participation in a weekly group exercise programme with ancillary home exercises can improve balance and reduce the rate of falling in at-risk community dwelling older people OBJECTIVES To compare the effectiveness of tai chi and low-level exercise in reducing falls in older adults ; to determine whether mobility , balance , and lower limb strength improved and whether higher doses of tai chi result ed in greater effect . DESIGN R and omized controlled trial . SETTING Eleven sites throughout New Zeal and . PARTICIPANTS Six hundred eighty-four community-residing older adults ( mean age 74.5 ; 73 % female ) with at least one falls risk factor . INTERVENTION Tai chi once a week ( TC1 ) ( n = 233 ) ; tai chi twice a week ( TC2 ) ( n = 220 ) , or a low-level exercise program control group ( LLE ) ( n = 231 ) for 20 wks . MEASUREMENTS Number of falls was ascertained according to monthly falls calendars . Mobility ( Timed-Up- and -Go Test ) , balance ( step test ) , and lower limb strength ( chair st and test ) were assessed . RESULTS The adjusted incident rate ratio ( IRR ) for falls was not significantly different between the TC1 and LLE groups ( IRR = 1.05 , 95 % confidence interval ( CI ) = 0.83 - 1.33 , P = .70 ) or between the TC2 and LLE groups ( IRR = 0.88 , 95 % CI = 0.68 - 1.16 , P = .37 ) . Adjusted multilevel mixed-effects Poisson regression showed a significant reduction in logarithmic mean fall rate of -0.050 ( 95 % CI = -0.064 to -0.037 , P < .001 ) per month for all groups . Multilevel fixed-effects analyses indicated improvements in balance ( P < .001 right and left leg ) and lower limb strength ( P < .001 ) but not mobility ( P = .54 ) in all groups over time , with no differences between the groups ( P = .37 ( right leg ) , P = .66 ( left leg ) , P = .21 , and P = .44 , respectively ) . CONCLUSION There was no difference in falls rates between the groups , with falls reducing similarly ( mean falls rate reduction of 58 % ) over the 17-month follow-up period . Strength and balance improved similarly in all groups over time Purpose : To assess some fall-related clinical variables ( balance , gait , fear of falling , functional autonomy , self-actualization and self-efficacy ) that might explain the fact that supervised Tai Chi has a better impact on preventing falls compared to a conventional physiotherapy program . Methods : The participants ( 152 older adults over 65 who were admitted to a geriatric day hospital program ) were r and omly assigned to either a supervised Tai Chi group or the usual physiotherapy . The presence of the clinical variables related to falls was evaluated before the intervention ( T1 ) , immediately after ( T2 ) , and 12 months after the end of the intervention ( T3 ) . Results : Both exercise programs significantly improved fall-related outcomes but only the Tai Chi intervention group decreased the incidence of falls . For both groups , most variables followed the same pattern , i.e. showed significant improvement with the intervention between T1 and T2 , and followed by a statistically significant decrease at the T3 evaluation . However , self-efficacy was the only variable that improved solely with the Tai Chi intervention ( p = 0.001 ) . Conclusions : The impact of supervised Tai Chi on fall prevention can not be explained by a differential effect on balance , gait and fear of falling . It appeared to be related to an increase of general self-efficacy , a phenomenon which is not seen in the conventional physiotherapy program . Implication s for Rehabilitation Each participant received a multidisciplinary intervention with either Tai Chi or physical therapy . Both interventions were associated with improved balance , gait , less fear of falling , improved functional autonomy and greater self actualisation . Only Tai Chi decreased the incidence of falls which appeared to be related to self-efficacy . Tai Chi seems to be a good alternative to physical therapy exercises to prevent falls in frail older people CONTEXT Because Tai Chi ( TC ) is beneficial to elders without cognitive impairment ( CI ) , it also may benefit elders with CI . But elders with CI have generally been excluded from TC studies because many measurement tools require verbal reports that some elders with CI are unable to provide . OBJECTIVES To test the efficacy of a TC program in improving pain and other health outcomes in community-dwelling elders with knee osteoarthritis ( OA ) and CI . METHODS This pilot cluster-r and omized trial was conducted between January 2008 and June 2010 ( Clinical Trials.gov Identifier : NCT01528566 ) . The TC group attended Sun style TC classes , three sessions a week for 20 weeks ; the control group attended classes providing health and cultural information for the same length of time . Measures included the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) pain , physical function and stiffness subscales ; the Get Up and Go test ; the Sit-to-St and test ; and the Mini-Mental State Examination ( MMSE ) , administered at baseline , every four weeks during the intervention and at the end of the study ( post-test ) . RESULTS Eight sites participated in either the TC group ( four sites , 28 participants ) or control group ( four sites , 27 participants ) . The WOMAC pain ( P = 0.006 ) and stiffness scores ( P = 0.010 ) differed significantly between the two groups at post-test , whereas differences between the two groups in the WOMAC physical function score ( P = 0.071 ) and the MMSE ( P = 0.096 ) showed borderline significance at the post-test . WOMAC pain ( P = 0.001 ) , physical function ( P = 0.021 ) , and stiffness ( P ≤ 0.001 ) scores improved significantly more over time in the TC group than in controls . No adverse events were found in either group . CONCLUSION Practicing TC can be efficacious in reducing pain and stiffness in elders with knee OA and CI Balance ability decreases with age , which results in an increased risk of falls for people over age 65 . Tai Chi exercise appears to offer potential benefits in the reduction of falls for the elderly . The purpose of the present study was to examine the effects of extended ( 6- and 12-month ) Tai Chi exercise interventions on balance and selected motor functions for senior citizens . Forty-seven subjects were recruited from two local senior centers . Twenty of them ( M = 71.8 years , SD = 7.1 ) , 11 in the Tai Chi exercise group and 9 in the control group , completed the pre- , mid- and post-tests over 12 months on five selected functional performance tests : static balance , dynamic balance , choice reaction time , heel-rise strength , and ankle flexibility . The Tai Chi group was provided with a one-hour Tai Chi exercise session per week for 12 months ; the control group did not participate in any exercise program . Results showed that static balance improved significantly after a 6-month Tai Chi intervention . Moreover , the Tai Chi group maintained a higher level in the test performance compared with the control group at the end of the 12-month intervention , but there was no significant difference between the two groups . Data suggested that Tai Chi exercise intervention could produce a positive influence on balance control for the elderly over a prolonged period , but not on muscle strength and ankle flexibility
Output:
| In conclusion , TCC practice was beneficial to improve the balance control ability and flexibility of older adults , which may be the reason of preventing falls |
MS212279 | ***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: It is possible that dietary nitrate ( NO3− ) supplementation may improve both physical and cognitive performance via its influence on blood flow and cellular energetics . Purpose To investigate the effects of dietary NO3− supplementation on exercise performance and cognitive function during a prolonged intermittent sprint test ( IST ) protocol , which was design ed to reflect typical work patterns during team sports . Methods In a double-blind r and omised crossover study , 16 male team-sport players received NO3−-rich ( BR ; 140 mL day−1 ; 12.8 mmol of NO3− ) , and NO3−-depleted ( PL ; 140 mL day−1 ; 0.08 mmol NO3− ) beetroot juice for 7 days . On day 7 of supplementation , subjects completed the IST ( two 40-min “ halves ” of repeated 2-min blocks consisting of a 6-s “ all-out ” sprint , 100-s active recovery and 20 s of rest ) , on a cycle ergometer during which cognitive tasks were simultaneously performed . Results Total work done during the sprints of the IST was greater in BR ( 123 ± 19 kJ ) compared to PL ( 119 ± 17 kJ ; P < 0.05 ) . Reaction time of response to the cognitive tasks in the second half of the IST was improved in BR compared to PL ( BR first half : 820 ± 96 vs. second half : 817 ± 86 ms ; PL first half : 824 ± 114 vs. second half : 847 ± 118 ms ; P < 0.05 ) . There was no difference in response accuracy . Conclusions These findings suggest that dietary NO3− enhances repeated sprint performance and may attenuate the decline in cognitive function ( and specifically reaction time ) that may occur during prolonged intermittent exercise The influence of dietary nitrate ( NO3- ) supplementation on indices of maximal sprint and intermittent exercise performance is unclear . PURPOSE To investigate the effects of NO3- supplementation on sprint running performance , and cognitive function and exercise performance during the sport-specific Yo-Yo Intermittent Recovery level 1 test ( IR1 ) . METHODS In a double-blind , r and omized , crossover study , 36 male team-sport players received NO3 - -rich ( BR ; 70 mL·day-1 ; 6.4 mmol of NO3- ) , and NO3 - -depleted ( PL ; 70 mL·day-1 ; 0.04 mmol NO3- ) beetroot juice for 5 days . On day 5 of supplementation , subjects completed a series of maximal 20-m sprints followed by the Yo-Yo IR1 . Cognitive tasks were completed prior to , during and immediately following the Yo-Yo IR1 . RESULTS BR improved sprint split times relative to PL at 20 m ( 1.2 % ; BR 3.98 ± 0.18 vs. PL 4.03 ± 0.19 s ; P < 0.05 ) , 10 m ( 1.6 % ; BR 2.53 ± 0.12 vs. PL 2.57 ± 0.19 s ; P < 0.05 ) and 5 m ( 2.3 % ; BR 1.73 ± 0.09 vs. PL 1.77 ± 0.09 s ; P < 0.05 ) . The distance covered in the Yo-Yo IR1 test improved by 3.9 % ( BR 1422 ± 502 vs. PL 1369 ± 505 m ; P < 0.05 ) . The reaction time to the cognitive tasks was shorter in BR ( 615 ± 98 ms ) than PL ( 645 ± 120 ms ; P < 0.05 ) at rest but not during the Yo-Yo IR1 . There was no difference in response accuracy . CONCLUSIONS Dietary NO3- supplementation enhances maximal sprint and high-intensity intermittent running performance in competitive team sport players . Our findings suggest that NO3- supplementation has the potential to improve performance in single-sprint or multiple-sprint ( team ) sports BACKGROUND Dietary nitrate is receiving increased attention due to its reported ergogenic and cardioprotective properties . The extent to which ingestion of various nitrate-rich vegetables increases postpr and ial plasma nitrate and nitrite concentrations and lowers blood pressure is currently unknown . OBJECTIVE We aim ed to assess the impact of ingesting different nitrate-rich vegetables on subsequent plasma nitrate and nitrite concentrations and resting blood pressure in healthy normotensive individuals . METHODS With the use of a semir and omized crossover design , 11 men and 7 women [ mean ± SEM age : 28 ± 1 y ; mean ± SEM body mass index ( BMI , in kg/m(2 ) ) : 23 ± 1 ; exercise : 1 - 10 h/wk ] ingested 4 different beverages , each containing 800 mg ( ∼12.9 mmol ) nitrate : sodium nitrate ( NaNO3 ) , concentrated beetroot juice , a rocket salad beverage , and a spinach beverage . Plasma nitrate and nitrite concentrations and blood pressure were determined before and up to 300 min after beverage ingestion . Data were analyzed using repeated- measures ANOVA . RESULTS Plasma nitrate and nitrite concentrations increased after ingestion of all 4 beverages ( P < 0.001 ) . Peak plasma nitrate concentrations were similar for all treatments ( all values presented as means ± SEMs : NaNO3 : 583 ± 29 μmol/L ; beetroot juice : 597 ± 23 μmol/L ; rocket salad beverage : 584 ± 24 μmol/L ; spinach beverage : 584 ± 23 μmol/L ) . Peak plasma nitrite concentrations were different between treatments ( NaNO3 : 580 ± 58 nmol/L ; beetroot juice : 557 ± 57 nmol/L ; rocket salad beverage : 643 ± 63 nmol/L ; spinach beverage : 980 ± 160 nmol/L ; P = 0.016 ) . When compared with baseline , systolic blood pressure declined 150 min after ingestion of beetroot juice ( from 118 ± 2 to 113 ± 2 mm Hg ; P < 0.001 ) and rocket salad beverage ( from 122 ± 3 to 116 ± 2 mm Hg ; P = 0.007 ) and 300 min after ingestion of spinach beverage ( from 118 ± 2 to 111 ± 3 mm Hg ; P < 0.001 ) , but did not change with NaNO3 Diastolic blood pressure declined 150 min after ingestion of all beverages ( P < 0.05 ) and remained lower at 300 min after ingestion of rocket salad ( P = 0.045 ) and spinach ( P = 0.001 ) beverages . CONCLUSIONS Ingestion of nitrate-rich beetroot juice , rocket salad beverage , and spinach beverage effectively increases plasma nitrate and nitrite concentrations and lowers blood pressure to a greater extent than sodium nitrate . These findings show that nitrate-rich vegetables can be used as dietary nitrate supplements . This trial was registered at clinical trials.gov as NCT02271633 Dietary nitrate supplementation has been shown to reduce the oxygen ( O2 ) cost of exercise and enhance exercise tolerance in healthy individuals . This study assessed whether similar effects could be observed in individuals with type 2 diabetes ( T2DM ) . In a r and omized , double-blind , placebo-controlled crossover study , 48 participants with T2DM supplemented their diet for 4 days with either nitrate-rich beetroot juice ( 70ml/day , 6.43mmol nitrate/day ) or nitrate-depleted beetroot juice as placebo ( 70ml/day , 0.07mmol nitrate/day ) . After each intervention period , resting plasma nitrate and nitrite concentrations were measured subsequent to participants completing moderate-paced walking . Pulmonary gas exchange was measured to assess the O2 cost of walking . After a rest period , participants performed the 6-min walk test ( 6MWT ) . Relative to placebo , beetroot juice result ed in a significant increase in plasma nitrate ( placebo , 57±66 vs beetroot , 319±110µM ; P < 0.001 ) and plasma nitrite concentration ( placebo , 680±256 vs beetroot , 1065±607nM ; P < 0.001 ) . There were no differences between placebo juice and beetroot juice for the O2 cost of walking ( 946±221 vs 939±223ml/min , respectively ; P = 0.59 ) and distance covered in the 6MWT ( 550±83 vs 554±90 m , respectively ; P = 0.17 ) . Nitrate supplementation did not affect the O2 cost of moderate-paced walking or improve performance in the 6MWT . These findings indicate that dietary nitrate supplementation does not modulate the response to exercise in individuals with T2DM The matching of oxygen supply to neural dem and ( i.e. , neurovascular coupling ( NVC ) ) is an important determinant of cognitive performance . The impact of hypoxia on NVC remains poorly characterized . NVC is partially modulated by nitric oxide ( NO ) , which may initially decrease in hypoxia . This study investigated the effect of acute NO-donor ( nitrate ) supplementation on NVC and cognitive function in hypoxia . Twenty healthy men participated in this r and omized , double-blind , crossover design study . Following normoxic cognitive/NVC testing , participants consumed either nitrate ( NIT ) or a NIT-depleted placebo ( PLA ) . Participants then underwent 120 min of hypoxia ( 11.6 % ± 0.1 % O2 ) and all cognitive/NVC testing was repeated . NVC was assessed as change in middle cerebral artery ( MCA ) blood flow during a cognitive task ( incongruent Stroop ) using transcranial Doppler . Additional computerized cognitive testing was conducted separately to assess memory , executive function , attention , sensorimotor , and social cognition domains . Salivary nitrite significantly increased following supplementation in hypoxia for NIT ( + 2.6 ± 1.0 arbitrary units ( AU ) ) compared with PLA ( + 0.2 ± 0.3 AU ; p < 0.05 ) . Memory performance ( -6 ± 13 correct ) significantly decreased ( p < 0.05 ) in hypoxia while all other cognitive domains were unchanged in hypoxia for both PLA and NIT conditions ( p > 0.05 ) . MCA flow increased during Stroop similarly in normoxia ( PLA + 5 ± 6 cm·s(-1 ) , NIT + 7 ± 7 cm·s(-1 ) ) and hypoxia ( PLA + 5 ± 9 cm·s(-1 ) , NIT + 6 ± 7 cm·s(-1 ) ) ( p < 0.05 ) and this increase was not altered by PLA or NIT ( p > 0.05 ) . In conclusion , acute hypoxia result ed in significant reductions in memory concomitant with preservation of executive function , attention , and sensorimotor function . Hypoxia had no effect on NVC . Acute NIT supplementation had no effect on NVC or cognitive performance in hypoxia BACKGROUND Aging and obesity are associated with raised oxidative stress and a reduction of nitric oxide ( NO ) bioavailability , with subsequent decline in insulin sensitivity and endothelial function . Inorganic nitrate is converted into NO via a 2-step reduction process and may be an effective nutritional intervention to modify vascular and metabolic functions . OBJECTIVES This study tested whether inorganic nitrate supplementation improved glucose disposal and attenuated the acute effects of hyperglycemia on oxidative stress , inflammation , and vascular function in young and old obese participants . METHODS Ten young ( aged 18 - 44 y ) and 10 old ( aged 55 - 70 y ) obese participants consumed 75 g glucose followed by either potassium nitrate ( 7 mg/kg body weight ) or potassium chloride ( placebo ) in a r and omized , double-blind crossover design . Resting blood pressure ( BP ) , endothelial function , and blood biomarkers were measured for 3 h postintervention . Biomarkers included plasma nitrate/nitrite ( NOx ) , glucose , insulin , cyclic GMP , interleukin 6 , 3-nitrotyrosine , E- and P-selectins , intercellular adhesion molecule 3 ( ICAM-3 ) , and thrombomodulin , as well as superoxide in freshly isolated peripheral blood mononuclear cells ( P BMC s ) . RESULTS Inorganic nitrate supplementation did not affect plasma glucose ( P = 0.18 ) or insulin ( P = 0.26 ) responses . The increase in plasma NOx concentrations 3 h after the administration of inorganic nitrate was significantly higher in
Output:
| Nitrate and nitrite supplementation did not modify CBF or CF . |
MS212280 | ***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: OBJECTIVE Most data on the prevalence and behaviour of skin cancers is based on hospital studies . The scarcity of community based general practice skin surveys prompted this study . The aim of the survey was to : record the relative frequency of different skin tumours in an Adelaide general practice and compare these with rates published elsewhere . to record clinical accuracy of diagnosis , infection rates and completeness of excision . METHOD Five year prospect i ve study recording age , sex , site of excision and histological diagnosis of 369 skin excisions in a general practice . A sub study recorded clinical diagnostic accuracy , with subsequent histological diagnosis . RESULTS Non-melanotic skin cancer ( NMSC ) accounted for 59.9 % of the total lesions with basal cell carcinomas ( BCCs ) accounting for 30.6 % , squamous cell carcinomas ( SCCs ) 21.7 % , and intra epithelial cancer 7.6 % . The most frequent excision site was head , neck and face . A total of 75 % of SCCs occurred on sun exposed areas , whereas a significant proportion of BCCs occurred on the shoulder and trunk ( 37.1 % ) ; this agrees with recent trends in Australia . Clinical accuracy when compared with histology was 77 % comparing favourably with other published data . CONCLUSION Skin cancer continues to be a major community health issue in Australia in which general practitioners are heavily involved . Due to their expertise and early intervention at a community level , much is being done to reduce this cost in the community . Further research on NMSC trends are needed , especially in general practice A decision support system for the management of oral hypoglycaemic therapy in type II diabetes was evaluated . The ruleset contained therein forms the basis of a prototype computer programme , but in order to assess the robustness of the individual rules , it was decided it was necessary to use a paper-based form of the ruleset . A nurse with no previous experience of managing type II diabetes was trained to use the system and then undertook the exclusive management of half of all new type II diabetics , from a district population of 300,000 , over a 16-month period . General practice s within this area were divided into two groups , study and control , matching for size , geographical area and st and ards of existing diabetes care . Patients ( n = 102 ) from the study group practice s were then assigned to her care . Those patients ( n = 116 ) in the control group of practice s were treated according to their normal procedures . The decision support system for oral hypoglycaemic therapy was based on the following criteria : the current type of treatment ( six levels ) ; current glycaemic control ( HbA1 and FBS)-whether improving , steady or worsening ; and weight-%IBW , whether rising , steady or falling . Each of these parameters was carefully defined on the basis of established practice and clinical experience . Patients after initial education were seen at their usual clinic by the nurse only , on a monthly basis , until satisfactory glycaemic control was established and thereafter review ed 3 monthly . She was also responsible for ensuring the organisation of Diabetes Annual Review procedures . The medical records of the control group patients were examined at the end of the study and data on glycaemic control and Annual Review s extracted . In the study group 98 % patients achieved HbA1 levels within the normal range and all patients had full annual review s performed . The control practice s achieved much poorer degrees of metabolic control ( P < 0.01 ) and completed fewer annual review s. The study group did not demonstrate a significantly increased frequency of clinical hypoglycaemia consequent upon better blood sugar control . No exceptions to the ruleset , as initially defined , were detected . In conclusion , this decision support system was successful at achieving st and ards of diabetes control and care equal to or better than conventional structures of diabetes care . Implementation of such a system , on a simple computer platform , could greatly assist and possibly improve diabetes management in general practice Objective To evaluate whether nurse run clinics in general practice improve secondary prevention in patients with coronary heart disease . Design R and omised controlled trial . Setting A r and om sample of 19 general practice s in northeast Scotl and . Patients 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease , but without terminal illness or dementia and not housebound . Intervention Nurse run clinics promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures Components of secondary prevention assessed at baseline and one year were : aspirin use ; blood pressure management ; lipid management ; physical activity ; dietary fat ; and smoking status . A cumulative score was generated by counting the number of appropriate components of secondary prevention for each patient . Results There were significant improvements in aspirin management ( odds ratio 3.22 , 95 % confidence interval 2.15 to 4.80 ) , blood pressure management ( 5.32 , 3.01 to 9.41 ) , lipid management ( 3.19 , 2.39 to 4.26 ) , physical activity ( 1.67 , 1.23 to 2.26 ) and diet ( 1.47 , 1.10 to 1.96 ) . There was no effect on smoking cessation ( 0.78 , 0.47 to 1.28 ) . Of six possible components of secondary prevention , the baseline mean was 3.27 . The adjusted mean improvement attributable to intervention was 0.55 of a component ( 0.44 to 0.67 ) . Improvement was found regardless of practice baseline performance . Conclusions Nurse run clinics proved practical to implement in general practice and effectively increased secondary prevention in coronary heart disease . Most patients gained at least one effective component of secondary prevention and , for them , future cardiovascular events and mortality could be reduced by up to a third Although low dose aspirin reduces risk in patients with heart disease , many such patients do not receive daily prophylactic aspirin.1 We report a trial of feedback of general practitioners ' data on aspirin prescribing aim ed at increasing coded aspirin prescribing in patients with heart disease . Computerised practice s were r and omised to receive feedback on their prescribing , either of aspirin for patients with ischaemic heart disease or of hormone replacement therapy for women who had had hysterectomies . We approached 48 practice s in north London ; nine refused , and 11 were excluded . Of the 28 ( 58 % ) practice s in the study , seven were single h and ed and six had five or more partners . All participating practice s used the emis computer system except two that used Paradoc ; both systems yielded sufficiently reliable and comparable data . Eligible practice s had to have computerised information on hysterectomies and ischaemic heart disease and use their systems for repeat prescribing . Practice s were then r and omised by using sealed envelopes to Abstract Objective : To determine whether locally developed guidelines on asthma and diabetes disseminated through practice based education improve quality of care in non-training , inner city general practice s. Design : R and omised controlled trial with each practice receiving one set of guidelines but providing data on the management of both conditions . Subjects:24 inner city , non-training general practice s. Setting : East London . Main outcome measures : Recording of key variables in patient records ( asthma : peak flow rate , review of inhaler technique , review of asthma symptoms , prophylaxis , occupation , and smoking habit ; diabetes : blood glucose concentration , glycaemic control , funduscopy , feet examination , weight , and smoking habit ) ; size of practice disease registers ; prescribing in asthma ; and use of structured consultation “ prompts . ” Results : In practice s receiving diabetes guidelines , significant improvements in recording were seen for all seven diabetes variables . Both groups of practice s showed improved recording of review of inhaler technique , smoking habit , and review of asthma symptoms . In practice s receiving asthma guidelines , further improvement was seen only in recording of review of inhaler technique and quality of prescribing in asthma . Sizes of disease registers were unchanged . The use of structured prompts was associated with improved recording of four of seven variables on diabetes and all six variables on asthma . Conclusions : Local guidelines disseminated via practice based education improve the management of diabetes and possibly of asthma in inner city , non-training practice s. The use of simple prompts may enhance this improvement This study examined the blood pressure ( BP ) control and number of drugs prescribed for a sample of hypertensive patients from 18 practice s in Northeast Engl and . Out of a total of 35,379 registered patients aged 40 - 69 years , 2995 ( 8.5 % ) were on treatment for hypertension . Data was abstract ed from the practice records of a r and om sample of 691 patients . Using British Hypertension Society st and ards , BP control was optimal for systolic pressure ( less than 160 mm Hg ) in 469 ( 68 % ) , and for diastolic pressure ( less than 90 mm Hg ) in 345 ( 50 % ) , but only 269 ( 39 % ) had optimally controlled systolic and diastolic pressures . Sixty-one per cent were taking one drug and 39 % two or more ; 82 % of patients aged 40 - 49 years but only 61 % of those aged 60 - 69 years had optimally controlled systolic pressures . Forty-three per cent of the 40 to 49-year-old group and 56 % of the 60 to 69-year-old group had optimally controlled diastolic pressures . A strong inverse relationship was found between age and systolic BP control but there was no association between age and diastolic pressure or the number of drugs being prescribed . Sub-optimal BP control is a major problem and remedial strategies should stress the greater gain from treating older patients OBJECTIVES To monitor the documentation of blood pressure measurements and other cardiovascular risk factors in general practice patients with hypertension . METHOD Twenty-five case notes of patients diagnosed as hypertensive were r and omly selected from each of 58 participating general practitioners in suburban general practice in Adelaide , South Australia and were monitored by two registered nurses . MAIN OUTCOME MEASURES to assess whether blood pressure readings , weight , smoking history , alcohol intake and family history were documented , and whether electrocardiogram , plasma lipids , urinalysis and biochemical screen ( which includes blood urea nitrogen , creatinine , glucose , electrolytes and uric acid ) had been undertaken . RESULTS Data from 1446 hypertensive patients showed that for the last three blood pressure values recorded , 483 ( 33 % ) had an average level of 140/90 mm Hg or less and 1100 ( 76 % ) had an average of 160/95 mm Hg or less . The other cardiovascular risk factors selected were variably recorded , with biochemical screen being most commonly recorded [ 1198 ( 83 % ) ] and family history [ 423 ( 29 % ) ] the least . CONCLUSIONS Inadequacies in the control of hypertension and in the documentation of other cardiovascular risk factors suggest that further educational initiatives are required in this common chronic illness Initiation , distribution , concomitants and follow-up of cholesterol testing were studied in Grampian . Data were examined for 4979 patients , representing all patients in one year from those general practice s who made exclusive use of the clinical chemistry laboratory for cholesterol testing . A r and om sample of 215 patients was studied in further detail . Age and sex distribution , results of cholesterol tests and their follow-up , nature and results of associated biochemical tests , test initiation , testing rates by practice , and prescription rates of lipid lowering agents by practice were measured . Cholesterol testing was mostly in line with current knowledge of cardiovascular risk , and associated with further cardiovascular and biochemical assessment . There was a 90-fold range in practice cholesterol testing rates , and a similarly wide range in prescription rates of lipid lowering agents ; there was a significant correlation between these . Rates and results of follow-up testing suggests a “ rule of halves ” for cholesterol testing BACKGROUND The appropriateness of epilepsy as a topic for general practice audit activity has been emphasized , but few audits have been undertaken to data and those that have are small scale . Historically , management of epilepsy has been a neglected area , and services for people with epilepsy remain generally poor . AIM The study was design ed to examine the process of care for people with epilepsy through a region-wide audit of general practitioner records . METHOD General practitioners in 31 r and omly selected general practice s in one UK health region undertook a notes audit for all patients identified as having active epilepsy ( patients who had had seizures in the last 2 years , or were currently seizure-free but on antiepileptic medication ) . A st and ard pro forma was used to collect information relating to diagnosis , drug treatment , and primary and secondary care contacts . RESULTS Recording of information in the notes was generally good , but poor for some key items essential to the effective management of the condition ; results suggest that a number of recommendations about provision of care for epilepsy are not being met : in particular , EEG and CT investigations often appear poorly directed ; prescribed antiepileptic therapy is not always optimal ; significant numbers of patients are being treated in hospital by non-neurologists ; there is little evidence of any regular review being undertaken by general practitioners of their patients with epilepsy ; and counselling about the non- clinical aspects of epilepsy often appears inadequate . CONCLUSIONS Despite recommendations in a number of recent reports , gaps and inconsistencies in epilepsy care persist , both at the primary and secondary level . The means by which such shortcomings can be reduced ( e.g. by specialist epilepsy nurses working across the primary - secondary care interface ) should now be systematic ally examined . The study has highlighted a need for
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| This study adopts an overview of the magnitude and the nature of clinical quality problems in general practice in three countries . |
MS212281 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
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Input: OBJECTIVES To determine lower genital tract carriage rates of C. trachomatis , N. gonorrhoeae and bacterial vaginosis among women seeking termination of pregnancy . To compare two clinical management strategies for minimising the risks of infective morbidity after induced abortion . DESIGN Prevalence of infections was assessed by screening women undergoing abortion . Clinical management strategies were compared by a r and omised trial . SETTING The gynaecology departments of four hospitals in Scotl and . PARTICIPANTS 1672 women undergoing induced abortion . INTERVENTIONS Women r and omised to prophylaxis received metronidazole 1 g rectally before abortion plus doxycycline 100 mg twice daily for seven days . Women r and omised to screen- and -treat received appropriate antibiotics only if screening proved positive for one or more infection . MAIN OUTCOME MEASURES Prevalences of infections ; morbidity in the eight weeks following abortion as assessed by reported symptoms , general practitioner consultation and prescription rates and hospital re-attendances ; costs to the NHS of alternative managements . RESULTS Prevalence rates : C. trachomatis 5.6 % ; N gonorrhoeae 0.19 % ; bacterial vaginosis 17.5 % . Overall , women allocated to receive prophylaxis had lower rates of measures of short term infective morbidity than those allocated to screen- and -treat . These differences only reached statistical significance for women who were reported negative on screening . The direct costs to the NHS of prophylaxis and screen- and -treat were calculated to be 8.17 and 18.34 per woman , respectively . CONCLUSIONS Prevalences of lower genital tract infections which have been implicated in increased rates of infective morbidity after abortion are similar to those reported elsewhere . Universal antibiotic prophylaxis is at least as effective as a policy of screen- and -treat in minimising the risk of short term infective morbidity and is far more cost efficient We compared the Gen-Probe transcription-mediated amplification assay ( AMP CT ) , the Abbott LCx assay , and the Roche COBAS AMPLICOR assay for the detection of Chlamydia trachomatis in a mixed population in urine sample s. First-void urine , urethral specimens , and cervical specimens in females were obtained from 1,000 patients ( 544 males and 456 females ) visiting the outpatient sexually transmitted disease clinic of our hospital . The prevalence of C. trachomatis infection was 7.7 % as determined by tissue culture of urethral and cervical specimens . The sensitivities of LCx , COBAS AMPLICOR , and AMP CT compared to cell culture were 79 , 86 , and 78 % , respectively . Sensitivity and specificity were recalculated by using a new " gold st and ard " , i.e. , a sample was considered to be true positive if two or more techniques yielded positive results . Specimens positive only by cell culture or positive in only one commercial amplification technique were retested by a previously described in-house PCR . After discordance analysis the sensitivities of LCx , COBAS AMPLICOR , and AMP CT were 84 , 93 , and 85 % , respectively . Specificity exceeded 99 % for all three assays . With each method the sensitivity was lower for urine sample s from females compared to urine sample s from males . By application of this new gold st and ard , existing differences between methods are highlighted ; future evaluations of new techniques should be vali date d against two or more amplification assays AIM : To test a new assay for the detection of human papillomavirus ( HPV ) DNA , hybrid capture II ( HC II ) , compared with the previous commercialized hybrid capture I ( HC I ) and polymerase chain reaction ( PCR ) results on cervical scrapes from fresh cone excision biopsy sample s. METHODS : The three methods were used on cervical scrapes from 42 fresh cone excision biopsy sample s. There were nine metaplastic and inflammatory lesions , five low grade lesions , and 28 high grade lesions . PCR was performed using the general primers GP5+/GP6 + . The viral load of high risk HPV DNA was estimated by the ratio of relative light units to positive control values in the sample s. RESULTS : The sensitivity of HC I for the detection of high grade lesions was 71.4 % , while it was 92.8 % for HC II and 96.4 % for the PCR . Considering only the absence of detectable cervical in situ neoplasia , the specificity was 88.9 % for HC I , 66.7 % for HC II , and 66.7 % for PCR . With HC II , for a ratio of cervical sample to normal control of > 200 , the sensitivity for the detection of high grade lesion was only 34.6 % with a specificity of 66.7 % . CONCLUSIONS : HPV detection with the HC II assay is more sensitive than the previous HC I and represents a more convenient and easier test than PCR for routine use . Nevertheless the viral load estimated with this test can not be a reliable predictive indicator of high grade lesions CONTEXT Treatment recommendations assume that repeated mass antibiotic distributions can control , but not eradicate or even locally eliminate , the ocular strains of chlamydia that cause trachoma . Elimination may be an important end point because of concern that infection will return to communities that have lost immunity to chlamydia after antibiotics are discontinued . OBJECTIVE To determine whether biannual treatment can eliminate ocular chlamydial infection from preschool children and to compare results with the World Health Organization-recommended annual treatment . DESIGN , SETTING , AND PARTICIPANTS A cluster-r and omized clinical trial of biannual vs annual mass azithromycin administrations to all residents of 16 rural villages in the Gurage Zone , Ethiopia , from March 2003 to April 2005 . INTERVENTIONS At scheduled treatments , all individuals aged 1 year or older were offered a single dose of oral azithromycin either annually or biannually . MAIN OUTCOME MEASURE Village prevalence of ocular chlamydial infection and presence of elimination at 24 months in preschool children determined by polymerase chain reaction , correcting for baseline prevalence . Antibiotic treatments were performed after sample collection s. RESULTS Overall , 14,897 of 16,403 eligible individuals ( 90.8 % ) received their scheduled treatment . In the villages in which residents were treated annually , the prevalence of infection in preschool children was reduced from a mean of 42.6 % ( range , 14.7%-56.4 % ) to 6.8 % ( range , 0.0%-22.0 % ) at 24 months . In the villages in which residents were treated biannually , infection was reduced from 31.6 % pretreatment ( range , 6.1%-48.6 % ) to 0.9 % ( range , 0.0%-4.8 % ) at 24 months . Biannual treatment was associated with a lower prevalence at 24 months ( P = .03 , adjusting for baseline prevalence ) . At 24 months , no infection could be identified in 6 of 8 of those treated biannually and in 1 of 8 of those treated annually ( P = .049 , adjusting for baseline prevalence ) . CONCLUSION Local elimination of ocular chlamydial infection appears feasible even in the most severely affected areas , although it may require biannual mass antibiotic distributions at a high coverage level . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00221364 Background Screening and active case finding for Chlamydia trachomatis ( CT ) is recommended to prevent reproductive morbidity . However insight in community prevalence of gonococcal infections and co-infections with Neisseria gonorrhoea ( NG ) is lacking . Methods Nested study within a large population -based Chlamydia Screening Pilot among 21.000 persons 15–29 year . All CT-positive ( 166 ) and a r and om sample of 605 CT-negative specimens were as well tested for gonococcal infection . Results Overall Chlamydia prevalence in the Pilot was 2.0 % ( 95 % CI : 1.7–2.3 ) , highest in very urban setting s ( 3.2 % ; 95 % CI : 2.4–4.0 ) and dependent of several risk factors . Four gonococcal infections were found among 166 participants with CT infection ( 4/166 = 2.4 % ; 95 % CI : 0.1%–4.7 % ) . All four had several risk factors and reported symptoms . Among 605 CT-negative persons , no infection with NG could be confirmed . Conclusion A low rate of co-infections and a very low community prevalence of gonococcal infections were found in this population based screening programme among young adults in the Netherl and s. Population screening for asymptomatic gonococcal infections is not indicated in the Netherl and s. Although co-infection with gonorrhoea among CT-positives is dependent on symptoms and well-known algorithms for elevated risks , we advise to test all CT-positives also for NG , whether symptomatic or asymptomatic In a prospect i ve study , the Gen-Probe PACE 2 ( GP ) assay was compared with Abbott Laboratories ' ligase chain reaction ( LCR ) assay for the detection of Chlamydia trachomatis . A total of 493 female patients consented to collection of two cervical sample s ; a first-void urine ( FVU ) sample was collected also from 446 of the participants . Cervical sample s were tested by both GP and LCR ; 16 sample s ( 3.1 % ) tested positive by both methods and no discrepant results were observed . All but one of the FVU sample s collected from patients with a positive cervical sample was positive for C. trachomatis by LCR . The stability of FVU sample s over time in the LCR test was also evaluated and proved to be significantly longer than the 4 days stated by the manufacturer . While LCR proved to be highly sensitive in detecting chlamydial infection in FVU sample s , no difference was noted between LCR and GP in the detection of cervical C. trachomatis infection in this study population Two antigen detection systems ( MicroTrak [ MT ] , Syva Co. , Palo Alto , Calif. ; and Chlamydiazyme [ CZ ] , Abbott Laboratories , North Chicago , Ill. ) were compared with semiquantitative culture for diagnosis of chlamydial infection in 1,059 patients . Cultures were done on microtiter plates and blind passaged once . Culture-negative but CZ- or MT-positive specimens were recultured . True positives were positive by either initial or repeat cultures . Of 827 nonpregnant and 231 pregnant patients , 9.1 and 12.1 % , respectively , had positive cultures . Overall sensitivity of the initial culture was 48.5 % without passage and 86.4 % with passage . The sensitivity of CZ was 67 % . The sensitivity of MT in our laboratory was 50 % ; however , further review of these specimens by Syva employees gave a combined sensitivity of 71.6 % . MT and CZ were more sensitive for pregnant patients ( MT , 84.6 % ; CZ , 85.7 % ) than for nonpregnant patients ( MT , 65.5 % ; CZ , 60.0 % ) . All the tests had specificities above 95 % . Of the specimens that were positive after initial culture without subculture , MT-negative specimens had a mean of 3.7 inclusion s in culture , and MT-positive specimens had a mean of 24.8 ( P = 0.002 ) ; CZ-negative specimens had a mean of 4.3 inclusion s , and CZ-positive specimens had a mean of 20.0 ( P = 0.026 ) . In addition , cultures of specimens from pregnant patients had more inclusion s than did those from gynecology patients , but this was not statistically significant ( P = 0.096 ) . No method is ideal ; however , MT and CZ were less sensitive than was this culture system for detecting chlamydial infection in patients in gynecology clinics and were of comparable sensitivity for pregnant patients Objectives : Chlamydia trachomatis ( Chlamydia ) is the most prevalent sexually transmitted bacterial infection and can cause considerable reproductive morbidity in women . Chlamydia screening programmes have been considered but policy recommendations are hampered by the lack of population based data . This paper describes the prevalence of Chlamydia in 15–29 year old women and men in rural and urban areas , as determined through systematic population based screening organised by the Municipal Public Health Services ( MHS ) , and discusses the implication s of this screening strategy for routine implementation . Methods : Stratified national probability survey according to “ area address density ” ( AAD ) . 21 000 r and omly selected women and men in four regions , aged 15–29 years received a home sampling kit . Urine sample s were returned by mail and tested by polymerase chain reaction ( PCR ) . Treatment was via the general practitioner , STI clinic , or MHS clinic . Results : 41 % ( 8383 ) responded by sending in urine and question naire . 11 % ( 2227 ) returned a refusal card . Non-
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| The risk of developing late complications after chlamydia lower genital tract infection appears low .
In screening programmes , chlamydia antibody testing , as an intermediate marker for potential adverse sequelae , might enable more precise estimates |
MS212282 | ***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 Seeking screening and treatment for chlamydia ( CT ) and gonorrhea ( GC ) by young women is critical to reduction of asymptomatic cervicitis and its complications . OBJECTIVES To evaluate the efficacy of a client-centered motivational behavioral intervention ( MBI ) , to promote seeking of sexually tranmitted infection ( STI ) checkups by young women . METHODS Three hundred seventy-six of 770 eligible sexually active , nonpregnant , English-speaking women ( mean age 18.5 years ) were recruited from an urban reproductive health clinic and r and omized to two groups : intervention plus st and ard care ( MBI ) or st and ard care alone ( SC ) . MBI ( two sessions plus booster ) was based on the Transtheoretical Model of Change and employed motivational interviewing . Outcome measures monitored for 12 months included : client-initiated clinic visits for STI checkups in response to seven high-risk sexual behaviors by self-report ( primary ) , consistent condom use , number of CT and GC episodes , and movement along the stages of change obtained at baseline and 6- and 12-month follow-up assessment s ( secondary ) . Analyses included chi-square , logistic regression , and generalized estimating equations . RESULTS At baseline , more than 70 % endorsed the action stage of change for seeking STI checkups for three of seven high-risk sexual behaviors . No significant differences were noted between the two groups for the primary or secondary outcomes . Across groups , having multiple partners and being pregnant or thinking one might be pregnant were associated with STI checkups . CONCLUSIONS This is the first known client-centered clinical trial to promote STI screening . Risk-taking and health-seeking behaviors are complex and interrelated with STI and pregnancy concerns . The intervention may have an effect if it is targeted to women in a less medically connected community-based sample BACKGROUND The ability of specific behaviour-change interventions to reduce HIV infection in young people remains question able . Since January 1999 , an adolescent sexual and reproductive health ( SRH ) intervention has been implemented in ten r and omly chosen intervention communities in rural Tanzania , within a community r and omised trial ( see below ; NCT00248469 ) . The intervention consisted of teacher-led , peer-assisted in-school education , youth-friendly health services , community activities , and youth condom promotion and distribution . Process evaluation in 1999 - 2002 showed high intervention quality and coverage . A 2001/2 intervention impact evaluation showed no impact on the primary outcomes of HIV seroincidence and herpes simplex virus type 2 ( HSV-2 ) seroprevalence but found substantial improvements in SRH knowledge , reported attitudes , and some reported sexual behaviours . It was postulated that the impact on " upstream " knowledge , attitude , and reported behaviour outcomes seen at the 3-year follow-up would , in the longer term , lead to a reduction in HIV and HSV-2 infection rates and other biological outcomes . A further impact evaluation survey in 2007/8 ( approximately 9 years post-intervention ) tested this hypothesis . METHODS AND FINDINGS This is a cross-sectional survey ( June 2007 through July 2008 ) of 13,814 young people aged 15 - 30 y who had attended trial schools during the first phase of the MEMA kwa Vijana intervention trial ( 1999 - 2002 ) . Prevalences of the primary outcomes HIV and HSV-2 were 1.8 % and 25.9 % in males and 4.0 % and 41.4 % in females , respectively . The intervention did not significantly reduce risk of HIV ( males adjusted prevalence ratio [ aPR ] 0.91 , 95%CI 0.50 - 1.65 ; females aPR 1.07 , 95%CI 0.68 - 1.67 ) or HSV-2 ( males aPR 0.94 , 95%CI 0.77 - 1.15 ; females aPR 0.96 , 95%CI 0.87 - 1.06 ) . The intervention was associated with a reduction in the proportion of males reporting more than four sexual partners in their lifetime ( aPR 0.87 , 95%CI 0.78 - 0.97 ) and an increase in reported condom use at last sex with a non-regular partner among females ( aPR 1.34 , 95%CI 1.07 - 1.69 ) . There was a clear and consistent beneficial impact on knowledge , but no significant impact on reported attitudes to sexual risk , reported pregnancies , or other reported sexual behaviours . The study population was likely to have been , on average , at lower risk of HIV and other sexually transmitted infections compared to other rural population s , as only youth who had reached year five of primary school were eligible . CONCLUSIONS SRH knowledge can be improved and retained long-term , but this intervention had only a limited effect on reported behaviour and no significant effect on HIV/STI prevalence . Youth interventions integrated within intensive , community-wide risk reduction programmes may be more successful and should be evaluated . TRIAL REGISTRATION Clinical Trials.gov CONTEXT Adolescent females often have questions or concerns about their contraceptive methods , and they may discontinue use if these questions are not answered . Little evidence exists on whether follow-up phone calls to address young women 's concerns can help sustain contraceptive use . METHODS Between 2005 and 2007 , a total of 805 females aged 14 - 18 attending a reproductive health clinic in San Francisco were r and omly assigned to receive either regular clinic services or regular clinic services plus nine follow-up phone calls over 12 months . The young women were surveyed at baseline and roughly six , 12 and 18 months later to measure condom and contraceptive use , rates of pregnancy and STDs , and other outcomes and mediators . Multiple linear and logistic regression repeated measures analyses were used to assess the program 's effects . RESULTS Clinic counselors completed only 2.7 calls per patient , and made 7.8 attempts for every completed call . Although contraceptive use increased from baseline to follow-up at six months in both groups , levels of condom and contraceptive use , and rates of pregnancy and STDs , did not differ between the intervention and control groups at any of the follow-up assessment s. Moreover , the intervention did not improve clinic utilization or satisfaction or have consistent positive effects on participants ' attitudes . CONCLUSIONS Reaching young women by phone after a clinic visit for contraception is challenging and does not appear to provide significant benefits beyond those provided by basic clinic services . More intensive interventions may be needed to markedly change adolescent sexual and contraceptive behavior OBJECTIVE To determine whether condom use among high-risk female adolescents could be increased by a behavioral intervention , with the use of infection with Chlamydia trachomatis as a biomarker of condom practice s. DESIGN Prospect i ve , r and omized , controlled intervention . SETTING Urban family planning and sexually transmitted disease clinics . PARTICIPANTS Two hundred nine female adolescents , aged 15 through 19 years , who were treated for C. trachomatis genitourinary infection , were r and omly assigned to st and ard ( control ) or experimental ( behavioral intervention ) groups . One hundred twelve subjects returned for follow-up 5 to 7 months after enrollment and comprise the study subjects . MEASUREMENTS Subjects completed a multiinstrument question naire measuring sexual behavior , condom practice s , attitudes and beliefs , cognitive complexity , sociodemographics , and motivation at enrollment and follow-up . Endourethral and endocervical sites were sample d for C. trachomatis . RESULTS Among the 112 subjects who returned for repeated examination , those who had received the experimental intervention reported increased use of condoms by their sexual partners for protection against sexually transmitted diseases ( odds ratio = 2.4 ; p = 0.02 ) and for vaginal intercourse ( odds ratio = 3.1 ; p = 0.005 ) at the 6-month follow-up . Multivariable logistic regression analysis controlling for condom use at enrollment demonstrated that the experimental intervention ( odds ratio = 2.8 ; p = 0.03 ) and the higher cognitive complexity ( odds ratio = 4.6 ; p = 0.02 ) independently contributed to greater condom use at follow-up . Despite greater use of condoms among the group who had received the intervention , use remained inconsistent and rates of reinfection with C. trachomatis were not significantly different ( 26 % vs 17 % ; p = 0.3 ) . CONCLUSION Although a brief behavioral intervention among high-risk female adolescents can increase condom use by their sexual partners , incident infection does not appear to be reduced , because condom use remained inconsistent PURPOSE To evaluate an intervention ( based on one which had previously been successful in reducing adolescent human immunodeficiency virus ( HIV ) risk behaviors in the United States ) among adolescents residing in Namibia , a country located in sub-Saharan Africa . METHODS A r and omized trial of a 14-session face-to-face intervention emphasizing abstinence and safer sex was conducted among 515 youth ( median age 17 years ; median grade 11 ) attending 10 secondary schools located in two districts in Namibia . Knowledge , attitudes , intentions , and HIV risk behaviors were assessed at baseline and in the immediate postintervention period . RESULTS Knowledge increased significantly among intervention compared to control youth ( 88 % vs. 82 % ; correct responses , p < .0001 ) . At postintervention follow-up , more intervention than control youth believed that they could be intimate without having sex , could have a girlfriend or boyfriend for a long time without having sex , could explain the process of impregnation , knew how to use a condom , and could ask for condoms in a clinic . Fewer intervention than control youth believed that if a girl refused to have sex with her boyfriend it was permissible for him to strike her , and that condoms took away a boy 's pleasure . More intervention than control youth anticipated using a condom when they did have sex , and fewer expected to drink alcohol . Finally , after intervention , there was a trend for increased condom use . There were significant gender-related differences at baseline , although intervention impact was generally equivalent . CONCLUSIONS These findings provide support for the judicious adaptation of successful Western HIV prevention programs in other cultural setting s. A single intervention approach appears to be effective in short-term follow-up with both genders BACKGROUND The American Academy of Pediatrics , the Special Supplemental Nutrition Program for Women , Infants , and Children ( WIC ) , and the World Health Organization recommend that infants receive only breast milk or formula for the first 4 to 6 months of life , followed by the introduction of complementary foods . Despite these recommendations , many infants , particularly those with adolescent mothers , receive solid foods ( often cereal mixed with formula in a bottle ) and liquids other than formula or breast milk in the first few weeks of life . Decisions on early feeding are often guided by gr and mothers and influenced by beliefs that infants need complementary food to counteract signals of hunger , reduce crying , and sleep through the night . OBJECTIVE This investigation evaluated the efficacy of an intervention to delay the early introduction of complementary feeding among first-time , black , adolescent mothers living in multigenerational households . The intervention focused on reducing the cultural barriers to the acceptance of the recommendations of the American Academy of Pediatrics , WIC , and World Health Organization on complementary feeding by highlighting 3 topics : 1 ) recognition of infants ' cues ; 2 ) nonfood strategies for managing infant behavior ; and 3 ) mother-gr and mother negotiation strategies . The intervention was delivered through a mentorship model in which a videotape made by an advisory group of black adolescent mothers was incorporated into a home-visiting program and evaluated through a r and omized , controlled trial . METHODS One hundred eighty-one first-time , low-income , black mothers < 18 years old , living in multigenerational households were recruited from 3 urban hospitals . Infants were born at term , with birth weight appropriate for gestational age and no congenital problems . Shortly after delivery , mothers and gr and mothers completed a baseline assessment and mothers were r and omized into an intervention or control group . Intervention group mothers received home visitation every other week for 1 year . At 3 months , a subset of 121 adolescent mothers reported on their infant 's intake through a food frequency question naire . Mothers who fed their infant only breast milk , formula , or water were classified as optimal feeders . Mothers who provided complementary foods other than breast milk , formula , or water were classified as less optimal feeders . RESULTS Sixty-one percent of the infants received complementary foods before 3 months old . Multivariate hierarchical logistic regression was used to evaluate the determinants of being in the optimal versus less optimal feeders group . After controlling for infant age and family income , mothers of infants in the optimal feeders group were more likely to report accurate messages from WIC regarding the timing of complementary food and nearly 4 times more likely to be in the intervention group . The most common complementary food was cereal mixed with formula in the bottle . CONCLUSIONS The success of this relatively brief intervention demonstrates the importance of using ecological theory and ethnographic research to design interventions that enable participants to alter their behavior in the face of contradictory cultural norms . The intervention focused on interpreting infants ' cues , nonfood methods of managing infant behavior , and mother-gr and mother negotiations . It was delivered through methods that were familiar and acceptable to adolescent mothers-a mentorship model incorporating home visits and videotape . The skill-oriented aspects of the intervention delivered in a culturally sensitive context may have enabled the young mothers to follow the guidelines that they received from WIC and from their pediat
Output:
| The trials showed or reported no significant difference between study groups for pregnancy or HIV , but favorable effects were evident for some STI .
We found few studies and little clinical evidence of effectiveness for interventions promoting condom use for dual protection .
We did not find favorable results for pregnancy or HIV , and only found some for other STI .
Effective interventions for improving condom use are needed to prevent pregnancy and HIV/STI transmission . |
MS212283 | ***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 : To compare the postpartum pelvic floor function of women with sutured second-degree perineal lacerations , unsutured second-degree perineal lacerations , and intact perineums . Methods : A prospect i ve cohort of nurse-midwifery patients consented to mapping of genital trauma at birth and an assessment of postpartum pelvic floor outcomes . Women completed vali date d question naires for perineal pain and urinary and anal incontinence at 12 weeks postpartum and underwent physical examination to assess pelvic floor strength and anatomy at 6 weeks postpartum . Results : One hundred seventy-two of 212 ( 80 % ) eligible women provided follow-up assessment data at 6 or 12 weeks postpartum . Women with an intact perineum ( n = 89 ) used fewer analgesics ( P < .002 ) and had lower pain scores at the time of hospital discharge than women with second-degree lacerations ( sutured , n = 46 ; unsutured , n = 37 ; intact , n = 89 ) ( P ≤ .02 ) . The sutured group was more likely to use analgesics ( 52 % ) than the unsutured ( 35 % ) or intact ( 23 % ) groups at time of hospital discharge ( P < .002 ) , although pain scores were not different between sutured and unsutured groups . Postpartum reports of urinary or anal incontinence , sexual inactivity , or sexual function scores did not vary between groups . Weak pelvic floor exercise strength was more common among the women with second-degree lacerations compared with women with an intact perineum ( 53 % vs. 28 % ; P = .03 ) but did not differ between sutured ( 58 % ) and unsutured ( 47 % ) groups ( P = not significant ) . Likewise , perineal body or genital hiatus measurements did not vary between groups ( P = not significant ) . Conclusions : Women with sutured lacerations report increased analgesic use at the time of hospital discharge compared with women with intact perineums or unsutured lacerations . At 12 weeks postpartum , no differences were noted between groups regarding complaints of urinary or anal incontinence , sexual inactivity , or sexual function In a prospect i ve clinical investigation of 2,144 deliveries , we eluci date the indications for episiotomy and how different methods of anesthesia affect the frequency of episiotomy and the perineal problems after episiotomy compared with those after spontaneous perineal laceration . We found a significantly higher infection rate ( p less than 0.001 ) and a longer healing period in the episiotomy group . These differences remain even if only primigravida or the indication , imminent perineal laceration , is studied . The results indicate that many women will unnecessarily suffer after an episiotomy . The patient 's subjective problems are significantly increased , both immediately and at the 3-month postoperative follow-up Objective To assess the long term implication s of four alternative approaches to postpartum perineal repair . BACKGROUND The full extent of genital tract trauma in spontaneous births is not well documented . The purpose of this study was to describe the range and extent of childbirth trauma and related postnatal pain using data from a large r and omized clinical trial of perineal management techniques ( n = 5471 ) . METHODS Descriptive analysis was conducted on trial participants who delivered spontaneously at term and were examined by their midwife after birth ( n = 5404 ) . Data are reported for sites of trauma , and the relation to episiotomy , suturing , and maternal reports of pain at 2 days , 10 days , and 3 months after birth . RESULTS Eighty-five percent of all women experienced some form of trauma , with first- or second-degree perineal lacerations occurring in two-thirds of women and outer vaginal tears occurring in one-half . Tears to the rectum and vaginal vault were more common with episiotomy . Nearly all unsutured trauma was restricted to perineal first- or second-degree , outer vaginal , and labial sites . Pain declined over time , and a gradient in pain was observed according to the site and complexity of trauma . CONCLUSIONS Genital tract trauma is extremely common with spontaneous vaginal birth . Effective measures to prevent or reduce its occurrence would benefit many new mothers Objective . Surgical repair of perineal lesions after delivery is frequently associated with pain and discomfort , interfering with the normal activities of the puerperium . The aim of this study was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular suture , regarding the incidence of pain and wound complications . Study design . R and omized clinical trial . Setting . Tertiary care university hospital . Material and methods . One hundred women having mediolateral episiotomy at vaginal delivery were enrolled . They were r and omized to receive skin adhesive ( n = 53 ) or subcuticular suture ( n = 47 ) for closure of perineal skin . The main outcome measure was self‐evaluated pain in the 30 days following delivery . Secondary outcome measures were technical difficulties reported with the procedure , duration of surgical repair , wound complications observed at 42–68 hours post‐partum and re‐initiation of sexual activity by 30 days post‐partum . Results . No significant differences were observed between the two groups in incidence of technical difficulties and failed procedures , pain during the procedure , wound complications at hospital discharge , self‐evaluated measures of pain at 7 and 30 days or re‐initiation of sexual activity by 30 days post‐partum . The skin adhesive group had a significantly shorter mean duration of the procedure ( four minutes less ) . Conclusion . Perineal skin closure using adhesive glue is faster than subcuticular suture , and associated with a similar incidence of complications and pain in the first 30 days The association between episiotomy and severe ( third- and fourth-degree ) perineal lacerations was studied in 24,114 women . The overall rates of severe lacerations were 8.3 and 1.5 % for primiparous and multiparous women , respectively . Women who had midline episiotomies were nearly 50 times more likely and women who had mediolateral episiotomies were over eight times more likely to suffer a severe laceration than were women who did not undergo an episiotomy . Severe lacerations were also more common after use of forceps , in occiput transverse and posterior presentations , among women with smaller pelvic outlet measurements or lower prepregnant weight , and with larger fetuses . The same factors that caused a woman to have an increased risk of laceration also made performance of an episiotomy more likely . After statistical adjustment for these risk factors , mediolateral episiotomy was associated with a 2.5-fold reduction in the risk of severe lacerations among primiparous women , and a statistically nonsignificant 2.4-fold increase among multiparous women , compared with no episiotomy . Midline episiotomy was associated with statistically significant 4.2- and 12.8-fold increases in the risk of lacerations among primiparous and multiparous women , respectively . We conclude that the risks and benefits of midline episiotomy should be evaluated in a r and omized clinical trial that compares policies of “ usual ” versus conservative use of episiotomy Summary . Histoacryl‐tissue adhcsive ( B. Braun Melsungen AG W. Germany ) was used in place of skin sutures ( 2/0 chromic catgut , Ethicon Ltd , Edinburgh , Scotl and ) for episiotomy repair in a group of 20 women . This group was compared with two groups of women undergoing first and repeat episiotomy . Variables analysed included pain in the episiotomy site , pain while walking , sitting , sleeping , lying down , breast‐feeding , micturating and defaecating . The Histoacryl group was superior with regard to all the variables . This simple , new method can reduce pain and inconvenience for patients , especially following the first delivery Objective To compare the effect of two methods of perineal management used during spontaneous vaginal delivery on the prevalence of perineal pain reported at 10 days after birth OBJECTIVES The purpose of the study was to evaluate the use of enbucrilate tissue adhesive compared with subcuticular polyglycolic acid sutures in episiotomy wound closure . METHODS In a prospect i ve controlled trial , two groups were studied after undergoing an episiotomy skin wound repair using either enbucrilate tissue adhesive ( n=32 ) or a subcuticular polyglycolic acid suture ( n=30 ) . The variables measured included pain scores during selected activities in the first 5 postnatal days , the time taken to become pain free after childbirth and the time taken to resume pain free sexual intercourse . Suitable patients were invited by the midwives to participate in the trial . If they gave consent to the trial , the gynecologist was contacted . If available , he would perform a repair using enbucrilate tissue adhesive . If he was not available , one of the midwives would perform a repair using subcuticular polyglycolic acid sutures . In this group , 90 % of the women were recruited and sutured by one midwife . RESULTS Patients treated with enbucrilate were found to have significantly less postnatal pain while walking , became pain free in a shorter period ( mean=25 days vs. 18 days ; P<0.01 ) and were able to resume pain-free intercourse sooner ( mean=34 days vs. 52 days ; P<0.001 ) . CONCLUSIONS Tissue adhesives incorporate the qualities of an ideal skin-closure material . The results demonstrate their advantage over the current st and ard suture-based methods of repair in the perineum . The use of adhesives merits further evaluation Objective To examine differences in outcome between primiparous women who do and who do not have suturing to first or second degree perineal lacerations sustained during spontaneous vaginal births after 37 weeks of gestation Summary . Three methods of episiotomy repair were r and omly assigned after 900 consecutive deliveries . The three procedures were : ( 1 ) continuous No. 00‐plain catgut in the vagina ; No. 00‐plain catgut interrupted stiches in the perineal muscles and fascia , and No. 00‐nylon interrupted stiches in the skin . ( 2 ) The same technique as in ( l ) , but with No. 0‐polyglycolic acid ( Dexon ) in all layers . ( 3 ) The suture material as in ( 2 ) , but used with a subcuticular technique . The women treated with method 3 reported statistically significant less pain and disabilities in the early puerperium . Three months after delivery 262 women ( 33 % ) still had perineal complaints which could be directly related to the episiotomy in 25 % ( 8 % of total number ) . The group treated with method 3 had the best long‐term results and we conclude that the subcuticular technique using polyglycolic acid should be the method of choice BACKGROUND Midwives tend to leave minor perineal lacerations to heal spontaneously , and clinical experience and studies show that women can suffer from their stitched lacerations . The study purpose was to determine any differences in the healing process and experience of minor perineal lacerations when they were sutured or not sutured . METHODS Eighty term pregnant primiparas with minor perineal lacerations of grade s I-II were r and omized after childbirth . The experimental group was nonsutured and the control group was sutured . A follow-up examination was performed at 2 to 3 days , 8 weeks , and 6 months after the delivery . Participants were asked about the type of discomfort , and the effect of the laceration on breastfeeding and sexual intercourse . RESULTS No significant differences were found in the healing process . The type of pain differed between the groups , but the amount of discomfort was the same . The sutured group had to visit the midwife more often because of discomfort from the stitches . Sixteen percent of the women in the sutured group , but none in the nonsutured group ( p = 0.0385 ) , considered that the laceration had had a negative influence on breastfeeding . CONCLUSIONS Minor perineal lacerations can be left to heal spontaneously . The benefits for the woman include the possibility of having a choice , avoiding the discomfort of anesthesia and suturing , providing positive affects on breastfeeding One thous and women were allocated at r and om to one of two perineal management policies , both intended to minimise trauma during spontaneous vaginal delivery . In one the aim was to restrict episiotomy to fetal indications ; in the other the operation was to be used more liberally to prevent perineal tears . The result ant episiotomy rates were 10 % and 51 % respectively . An intact perineum was more common among those allocated to the restrictive policy . This group experienced more perineal and labial tears , however , and included four of the five cases of severe trauma . There were no significant differences between the two groups either in neonatal state or in maternal pain and urinary symptoms 10 days and three months post partum . Women allocated to the restrictive policy were more likely to have resumed sexual intercourse within a month after delivery . These findings provide little support either for liberal use of episiotomy or for cl aims that reduced use of the operation decreases postpartum morbidity Changes in sexual function are common in postpartum women . In this comparative , descriptive study , a prospect i ve cohort of midwifery patients consented to documentation of genital trauma at birth and assessment of sexual function at 3 months postpartum . The impact of spontaneous genital trauma on postpartum sexual function was the focus of the study . Trauma was categorized into minor trauma ( no trauma or first-degree perineal or other trauma that was not sutured ) or major trauma ( second- , third- , or fourth-degree lacerations or any trauma that required suturing ) . Women who underwent episiotomy or operative delivery
Output:
| There is limited evidence available from RCTs to guide the choice between surgical or non-surgical repair of first- or second-degree perineal tears sustained during childbirth .
Therefore , at present there is insufficient evidence to suggest that one method is superior to the other with regard to healing and recovery in the early or late postnatal periods .
Until further evidence becomes available , clinicians ' decisions whether to suture or not can be based on their clinical judgement and the women 's preference after informing them about the lack of long-term outcomes and the possible chance of a slower wound healing process , but possible better overall feeling of well being if left un-sutured |
MS212284 | ***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: Colorectal carcinoma ranks as the second most common cancer and the second leading cause of cancer death in the United States . Hispanics are less likely than their non‐Hispanic white counterparts to have ever received a fecal occult blood test ( FOBT ) or sigmoidoscopy/colonoscopy . Little is known about the barriers to screening in the Hispanic population This study aim ed to identify the social , cultural and psychological characteristics influencing behaviour in a cancer mass screening campaign in a French population . The intention to take a screening test and actually doing it was studied , in particular . A self reported- question naire was mailed in December 1992 to a r and om sample of people living in Caen ( western France ) , and aged from 45 - 74 years . The sample was formed by r and om selection from electoral registers . The study was population based , in the Caen area , department of Calvados , France . The question naire comprised 26 open and close questions . Starting in February 1993 , the occult blood screening test ( haemoccult IIR ) for colorectal cancer was offered by general practitioners ( GPs ) , occupational health doctors and pharmacists in the Caen area to all those aged 45 - 74 years . From 1 February 1993 to 30 June 1994 , the data on the mass screening campaign were central ized and the study population divided into those who took the screening test and those who did not . Of the 1,129 persons contacted , 645 ( 57.1 % ) returned the question naire . After exclusions , 585 question naires were used for analysis . The results show that whether a person will actually take a screening test can not be predicted from their intention to do so . The sociodemographic and cultural characteristics influencing the intention to take the test differ from those influencing execution of the test . Among the variables tested here , the following four sociodemographic and cultural characteristics were independently predictive of actually taking the screening test for colorectal cancer : compliance with the health insurer 's advice ; low or medium sociodemographic status , living with a partner ( or widowhood ) ; and not knowing someone with cancer . The analysis of the quantitative and qualitative differences between the intention to take the test and actually doing it could eluci date the reasons underlying refusal . Poor screening compliance has multiple causes . A record of intention to take a screening test alone is not appropriate . This type of study should no longer be carried out to determine the mechanisms underlying behaviour towards secondary prevention Objective — To survey screening practice s , knowledge , and attitudes towards screening among first degree relatives of people with colon cancer . Setting — A r and om sample of people with colon cancer listed on the New South Wales ( NSW ) Cancer Registry were mailed a question naire to be passed on to an appropriate first degree relative . Methods — Two hundred and twenty five first degree relatives completed a self administered question naire . Results — Although there were high levels of awareness about colorectal cancer , and attitudes towards colorectal cancer were generally positive , screening rates were low , and only three relatives had been screened in accordance with current Australian recommendations . Factors associated with previous participation in any type of screening test ( usually once ) included receiving a medical recommendation to screen , having more than one relative with colorectal cancer , being a sibling of the relative with colon cancer , the relative with cancer being female , and perceiving screening as messy , but not painful . Conclusions — Strategies to enhance screening awareness and participation among relatives need to be considered . This study provides some insight into factors to be considered in developing awareness programmes . Further research is required to explore these factors , and to identify ways to overcome barriers BACKGROUND Breast cancer is the most prevalent malignancy among women in Israel , and routine screening is recommended for early detection . In 1997 , a health management organization primary care centre in rural Israel established a 1-year programme wherein family physicians were encouraged to remind their patients to undergo breast cancer examinations . This study evaluates the impact of the physicians ' intervention on patient compliance . METHODS Family practitioners from two practice s were requested to discuss the importance of early breast cancer detection with all eligible patients who visited the clinic for any reason and to assist them in scheduling an appointment for screening . The files of the patients who received the recommendation were stamped accordingly . On completion of the programme , the physicians ' files were audited , and the potential c and i date s for breast cancer screening were divided into two groups : those who had received the intervention ( n = 251 ) and those who had not ( n = 187 ) ; results were also compared with those of a third group of patients who had gone for an examination on their own initiative ( n = 100 ) prior to the study ( i.e. did not require intervention ) . A r and om sample of half the patients also completed an ad hoc question naire covering sociodemographic variables and the impact of the doctors ' intervention on their behaviour . RESULTS Patients in the intervention group showed a significantly greater change in behaviour regarding breast cancer screening than the controls ( 32 % versus 13 % , P = 0.001 ) . This change was manifested particularly in the group of women aged 50 - 74 years who received the recommendation for mammography to be performed ( according to the guidelines ) . CONCLUSION Although this is a study in only two practice s , the results suggest that primary care physicians can significantly alter the behaviour of their patients regarding regular breast examinations . The use of a special reminder can also help the individual doctor to ensure that each patient has been properly instructed BACKGROUND An explanatory framework referred to as the Preventive Health Model was used to identify factors associated with prospect i ve adherence to colorectal cancer screening . METHODS Data on sociodemographic , psychosocial , social influence , and program factors were collected via telephone survey for 501 older adult members of an independent practice association-type health maintenance organization . Subjects were later mailed fecal occult blood tests for completion and return . Adherence was defined as the return of the tests within 90 days . RESULTS Structural analysis shows that for men ( N = 145 ) , perceived self-efficacy ( OR = 1.4 ) , salience and coherence of testing ( OR = 2.3 for a 5-point increment on a 30-point scale ) , and exposure to health education interventions ( OR = 6.8 ) were significant independent predictors of intention to adhere and of adherence . Among women ( N = 185 ) , predictors were age ( OR = 1.8 ) and salience and coherence of testing ( OR = 1.8 for a 5-point increment on a 30-point scale ) . CONCLUSIONS These findings indicate that for both men and women , adherence is influenced strongly by the extent to which the behavior is judged to make sense in everyday life . It also appears that additional education and encouragement may persuade men and younger women to participate in screening BACKGROUND Even though colorectal cancer ( CRC ) screening tests for persons 50 years of age or over are recommended to reduce colorectal cancer mortality , screening rates remain disturbingly low . METHODS Using r and om digit dialing , 355 telephone interviews were conducted with black and white men and women , 50 - 79 years of age , who resided in Genesee County , Michigan . The Health Belief Model provided the framework to assess attitudes and practice s regarding CRC screening . RESULTS For both endoscopic procedures , significantly higher percentages of whites than blacks were aware of the screening procedure ( P < 0.05 ) . Overall , fewer than 30 % of respondents were adherent to current CRC screening guidelines . Adherence was lowest for black females : 21 % for fecal occult blood test , 20 % for flexible sigmoidoscopy , and 12 % for colonoscopy . Black males compared to black females were about 2.8 times more likely to have had either flexible sigmoidoscopy or colonoscopy ( P < 0.05 ) . Physician recommendation was a powerful motivator to screening . Two consistent barriers to screening were the belief that : ( a ) the test is not needed ; and ( b ) the test is embarrassing . CONCLUSIONS Interventions directed at physicians and patients are essential to enhance CRC screening rates . CRC survival rates may be improved by physician-guided promotion of screening that focuses on identified barriers
Output:
| There were important inconsistencies among studies in the factors that were associated with screening .
Receiving recommendations from clinicians was the most consistent predictor identified across studies .
The review also revealed a consistent pattern of association with predictors related to familial aspects of CRC , such as strength of family history , and relationship to the affected relative .
Among the psychological constructs , " social influence " emerged as the most consistent predictor of screening participation .
This review provides evidence that clinicians , as well as use of family history and social networks , offer the most promising avenues to promoting and improving screening participation by individuals at increased risk of colorectal cancer |
MS212285 | ***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 Glucosamine and chondroitin sulfate are used to treat osteoarthritis . The multicenter , double-blind , placebo- and celecoxib-controlled Glucosamine/chondroitin Arthritis Intervention Trial ( GAIT ) evaluated their efficacy and safety as a treatment for knee pain from osteoarthritis . METHODS We r and omly assigned 1583 patients with symptomatic knee osteoarthritis to receive 1500 mg of glucosamine daily , 1200 mg of chondroitin sulfate daily , both glucosamine and chondroitin sulfate , 200 mg of celecoxib daily , or placebo for 24 weeks . Up to 4000 mg of acetaminophen daily was allowed as rescue analgesia . Assignment was stratified according to the severity of knee pain ( mild [ N=1229 ] vs. moderate to severe [ N=354 ] ) . The primary outcome measure was a 20 percent decrease in knee pain from baseline to week 24 . RESULTS The mean age of the patients was 59 years , and 64 percent were women . Overall , glucosamine and chondroitin sulfate were not significantly better than placebo in reducing knee pain by 20 percent . As compared with the rate of response to placebo ( 60.1 percent ) , the rate of response to glucosamine was 3.9 percentage points higher ( P=0.30 ) , the rate of response to chondroitin sulfate was 5.3 percentage points higher ( P=0.17 ) , and the rate of response to combined treatment was 6.5 percentage points higher ( P=0.09 ) . The rate of response in the celecoxib control group was 10.0 percentage points higher than that in the placebo control group ( P=0.008 ) . For patients with moderate-to-severe pain at baseline , the rate of response was significantly higher with combined therapy than with placebo ( 79.2 percent vs. 54.3 percent , P=0.002 ) . Adverse events were mild , infrequent , and evenly distributed among the groups . CONCLUSIONS Glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee . Exploratory analyses suggest that the combination of glucosamine and chondroitin sulfate may be effective in the subgroup of patients with moderate-to-severe knee pain . ( Clinical Trials.gov number , NCT00032890 . ) Background Pharmacological treatment for osteoarthritis ( OA ) can be divided into two groups : symptom-modifying drugs and disease-modifying drugs . Symptom-modifying drugs are currently the prescription of choice for patients with OA , as disease-modifying drugs are not yet available in usual care . However , there has recently been a lot of debate about glucosamine sulphate ( GS ) , a biological agent that is thought to have both symptom-modifying and disease-modifying properties . This assumption has yet to be proved . The objective of this article is to present the design of a blind r and omised clinical trial that examines the long-term symptom-modifying and disease-modifying effectiveness of GS in patients with hip OA . This trial is ongoing and will finish in March 2006 . Methods / design Patients with hip OA meeting the ACR- criteria are r and omly allocated to either 1500 mg of oral GS or placebo for the duration of two years . The primary outcome measures , which are joint space narrowing ( JSN ) , and change in the pain and function score of the Western Ontario McMaster Universities Osteoarthritis index ( WOMAC ) , are determined at baseline and after two years of follow-up during the final assessment . Intermediate measures at three-month intervals throughout the trial are used to study secondary outcome measures . Secondary outcome measures are changes in WOMAC stiffness score , quality of life , medical consumption , side effects and differences in biomarker CTX-II Summary A new preparation of pure glucosamine sulphate , in injectable and oral form , was investigated in a controlled clinical trial in patients with osteoarthrosis . Two groups of 15 in- patients received either 400 mg glucosamine sulphate daily ( 12by the intramuscular and 3 by the intra-articular route ) for 7 days , followed by 2 weeks at 1.5 g daily of oral glucosamine sulphate in 3 divided doses , or an intramuscular injection daily of a piperazine/chlorbutanol combination for 7 days , followed by oral placebo during the following 2 weeks . Semi-quantitative scoring of pain at rest and during active and passive movements , of restricted function and , where possible , of walking time over 20 metres , were taken as therapeutic activity indices , and tested before and after 1 and 3 weeks of treatment . Patients were positively question ed daily for possible intolerance symptoms . Laboratory tests were recorded before and after treatment . With both initial parenteral treatments , each symptom significantly improved , wit BACKGROUND Treatment of osteoarthritis is usually limited to short-term symptom control . We assessed the effects of the specific drug glucosamine sulphate on the long-term progression of osteoarthritis joint structure changes and symptoms . METHODS We did a r and omised , double-blind placebo controlled trial , in which 212 patients with knee osteoarthritis were r and omly assigned 1500 mg sulphate oral glucosamine or placebo once daily for 3 years . Weightbearing , anteroposterior radiographs of each knee in full extension were taken at enrolment and after 1 and 3 years . Mean joint-space width of the medial compartment of the tibiofemoral joint was assessed by digital image analysis , whereas minimum joint-space width -- ie , at the narrowest point -- was measured by visual inspection with a magnifying lens . Symptoms were scored by the Western Ontario and McMaster Universities ( WOMAC ) osteoarthritis index . FINDINGS The 106 patients on placebo had a progressive joint-space narrowing , with a mean joint-space loss after 3 years of -0.31 mm ( 95 % CI -0.48 to -0.13 ) . There was no significant joint-space loss in the 106 patients on glucosamine sulphate : -0.06 mm ( -0.22 to 0.09 ) . Similar results were reported with minimum joint-space narrowing . As assessed by WOMAC scores , symptoms worsened slightly in patients on placebo compared with the improvement observed after treatment with glucosamine sulphate . There were no differences in safety or reasons for early withdrawal between the treatment and placebo groups . INTERPRETATION The long-term combined structure-modifying and symptom-modifying effects of gluosamine sulphate suggest that it could be a disease modifying agent in osteoarthritis BACKGROUND Conventional symptomatic treatments for osteoarthritis do not favorably affect disease progression . The aim of this r and omized , placebo-controlled trial was to determine whether long-term ( 3-year ) treatment with glucosamine sulfate can modify the progression of joint structure and symptom changes in knee osteoarthritis , as previously suggested . METHODS Two hundred two patients with knee osteoarthritis ( using American College of Rheumatology criteria ) were r and omized to receive oral glucosamine sulfate , 1500 mg once a day , or placebo . Changes in radiographic minimum joint space width were measured in the medial compartment of the tibiofemoral joint , and symptoms were assessed using the algo-functional indexes of Lequesne and WOMAC ( Western Ontario and McMaster Universities ) . RESULTS Osteoarthritis was of mild to moderate severity at enrollment , with average joint space widths of slightly less than 4 mm and a Lequesne index score of less than 9 points . Progressive joint space narrowing with placebo use was -0.19 mm ( 95 % confidence interval , -0.29 to -0.09 mm ) after 3 years . Conversely , there was no average change with glucosamine sulfate use ( 0.04 mm ; 95 % confidence interval , -0.06 to 0.14 mm ) , with a significant difference between groups ( P = .001 ) . Fewer patients treated with glucosamine sulfate experienced predefined severe narrowings ( > 0.5 mm ) : 5 % vs 14 % ( P = .05 ) . Symptoms improved modestly with placebo use but as much as 20 % to 25 % with glucosamine sulfate use , with significant final differences on the Lequesne index and the WOMAC total index and pain , function , and stiffness subscales . Safety was good and without differences between groups . CONCLUSION Long-term treatment with glucosamine sulfate retarded the progression of knee osteoarthritis , possibly determining disease modification OBJECTIVE To assess whether improvement in knee pain biased the determination of the structure-modifying effect reported for glucosamine sulfate in two recent 3-year , r and omised , placebo-controlled clinical trials , in which conventional st and ing antero-posterior full extension knee radiographs were used for the measurement of joint space narrowing , and in which pain relief might have improved knee full extension . DESIGN Patients completing the 3-year treatment course were selected based on a WOMAC pain decrease at least equal to the mean improvement in the glucosamine sulfate arms in either of the original studies , irrespective of treatment with glucosamine sulfate or placebo ( drug responders or placebo responders ) . In a second approach , 3-year completers were selected if their baseline st and ing knee pain ( item # 5 of the WOMAC pain scale ) was ' severe ' or ' extreme ' and improved by any degree at the end of the trials . In both cases , changes in minimum joint space width were compared between treatment groups . RESULTS Global knee pain was mild-to-moderate in the two study population s and in all patient subsets identified . There were obviously more pain improvers in the glucosamine sulfate subsets ( N=76 in the two studies combined ) than in the placebo subsets ( N=57 ) , but WOMAC pain scores improved to the same extent , which was as large as over 50 % relative to baseline . Nevertheless , the placebo subsets in both studies underwent an evident mean ( SD ) joint space narrowing , which in the pooled analysis of both studies was -0.22 ( 0.80 ) mm , and was not observed with glucosamine sulfate : + 0.15 ( 0.60 ) mm ( P=0.003 vs placebo ) . Similar results were found in the smaller subsets with > or = severe baseline st and ing knee pain that improved after 3 years , with a joint space narrowing nevertheless of -0.28 ( 0.76 ) mm with placebo ( N=26 ) , not observed with glucosamine sulfate : + 0.21 ( 0.68 ) mm ( N=31 ; P=0.014 vs placebo ) . CONCLUSIONS Knee pain relief did not bias the report of a structure-modifying effect of glucosamine sulfate in two recent long-term trials using conventional st and ing antero-posterior radiographs , possibly due to the mild-to-moderate patient characteristics OBJECTIVE To assess the effects of the prescription formulation of glucosamine sulfate ( 1,500 mg administered once daily ) on the symptoms of knee osteoarthritis ( OA ) during a 6-month treatment course . METHODS Three hundred eighteen patients were enrolled in this r and omized , placebo-controlled , double-blind trial in which acetaminophen , the currently preferred medication for symptomatic treatment of OA , was used as a side comparator . Patients were r and omly assigned to receive oral glucosamine sulfate 1,500 mg once daily ( n = 106 ) , acetaminophen 3 gm/day ( n = 108 ) , or placebo ( n = 104 ) . The primary efficacy outcome measure was the change in the Lequesne index after 6 months . Secondary parameters included the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) and response according to the Osteoarthritis Research Society International criteria . These outcome measures were assessed using an intent-to-treat analysis . RESULTS At baseline , the study patients had moderately severe OA symptoms ( mean Lequesne index approximately 11 points ) . Glucosamine sulfate was more effective than placebo in improving the Lequesne score , with a final decrease of 3.1 points , versus 1.9 with placebo ( difference between glucosamine sulfate and placebo -1.2 [ 95 % confidence interval -2.3 , -0.8 ] ) ( P = 0.032 ) . The 2.7-point decrease with acetaminophen was not significantly different from that with placebo ( difference -0.8 [ 95 % confidence interval -1.9 , 0.3 ] ) ( P = 0.18 ) . Similar results were observed for the WOMAC . There were more responders to glucosamine sulfate ( 39.6 % ) and acetaminophen ( 33.3 % ) than to placebo ( 21.2 % ) ( P = 0.004 and P = 0.047 , respectively , versus placebo ) . Safety was good , and was comparable among groups . CONCLUSION The findings of this study indicate that glucosamine sulfate at the oral once-daily dosage of 1,500 mg is more effective than placebo in treating
Output:
| Some studies suggest that glucosamine may provide greater benefit to patients with less severe radiographic osteoarthritis than to patients with more severe disease ( 5 , 6 ) . |
MS212286 | ***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 Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use . Dabigatran is a new oral direct thrombin inhibitor . METHODS In this noninferiority trial , we r and omly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive , in a blinded fashion , fixed doses of dabigatran--110 mg or 150 mg twice daily -- or , in an unblinded fashion , adjusted-dose warfarin . The median duration of the follow-up period was 2.0 years . The primary outcome was stroke or systemic embolism . RESULTS Rates of the primary outcome were 1.69 % per year in the warfarin group , as compared with 1.53 % per year in the group that received 110 mg of dabigatran ( relative risk with dabigatran , 0.91 ; 95 % confidence interval [ CI ] , 0.74 to 1.11 ; P<0.001 for noninferiority ) and 1.11 % per year in the group that received 150 mg of dabigatran ( relative risk , 0.66 ; 95 % CI , 0.53 to 0.82 ; P<0.001 for superiority ) . The rate of major bleeding was 3.36 % per year in the warfarin group , as compared with 2.71 % per year in the group receiving 110 mg of dabigatran ( P=0.003 ) and 3.11 % per year in the group receiving 150 mg of dabigatran ( P=0.31 ) . The rate of hemorrhagic stroke was 0.38 % per year in the warfarin group , as compared with 0.12 % per year with 110 mg of dabigatran ( P<0.001 ) and 0.10 % per year with 150 mg of dabigatran ( P<0.001 ) . The mortality rate was 4.13 % per year in the warfarin group , as compared with 3.75 % per year with 110 mg of dabigatran ( P=0.13 ) and 3.64 % per year with 150 mg of dabigatran ( P=0.051 ) . CONCLUSIONS In patients with atrial fibrillation , dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin , as well as lower rates of major hemorrhage . Dabigatran administered at a dose of 150 mg , as compared with warfarin , was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage . ( Clinical Trials.gov number , NCT00262600 . BACKGROUND Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects . The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known . METHODS We conducted a r and omized , double-blind , double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation ( median follow-up , 2.8 years ) . The primary efficacy end point was stroke or systemic embolism . Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period . The principal safety end point was major bleeding . RESULTS The annualized rate of the primary end point during treatment was 1.50 % with warfarin ( median time in the therapeutic range , 68.4 % ) , as compared with 1.18 % with high-dose edoxaban ( hazard ratio , 0.79 ; 97.5 % confidence interval [ CI ] , 0.63 to 0.99 ; P<0.001 for noninferiority ) and 1.61 % with low-dose edoxaban ( hazard ratio , 1.07 ; 97.5 % CI , 0.87 to 1.31 ; P=0.005 for noninferiority ) . In the intention-to-treat analysis , there was a trend favoring high-dose edoxaban versus warfarin ( hazard ratio , 0.87 ; 97.5 % CI , 0.73 to 1.04 ; P=0.08 ) and an unfavorable trend with low-dose edoxaban versus warfarin ( hazard ratio , 1.13 ; 97.5 % CI , 0.96 to 1.34 ; P=0.10 ) . The annualized rate of major bleeding was 3.43 % with warfarin versus 2.75 % with high-dose edoxaban ( hazard ratio , 0.80 ; 95 % CI , 0.71 to 0.91 ; P<0.001 ) and 1.61 % with low-dose edoxaban ( hazard ratio , 0.47 ; 95 % CI , 0.41 to 0.55 ; P<0.001 ) . The corresponding annualized rates of death from cardiovascular causes were 3.17 % versus 2.74 % ( hazard ratio , 0.86 ; 95 % CI , 0.77 to 0.97 ; P=0.01 ) , and 2.71 % ( hazard ratio , 0.85 ; 95 % CI , 0.76 to 0.96 ; P=0.008 ) , and the corresponding rates of the key secondary end point ( a composite of stroke , systemic embolism , or death from cardiovascular causes ) were 4.43 % versus 3.85 % ( hazard ratio , 0.87 ; 95 % CI , 0.78 to 0.96 ; P=0.005 ) , and 4.23 % ( hazard ratio , 0.95 ; 95 % CI , 0.86 to 1.05 ; P=0.32 ) . CONCLUSIONS Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes . ( Funded by Daiichi Sankyo Pharma Development ; ENGAGE AF-TIMI 48 Clinical Trials.gov number , NCT00781391 . ) OBJECTIVES This study assessed the feasibility of implanting a device in the left atrial appendage ( LAA ) in patients with atrial fibrillation ( AF ) to prevent thromboembolic stroke . BACKGROUND Meta-analyses confirmed that in cases of left atrial thrombus in nonrheumatic AF patients approximately 90 % of them are in the LAA . METHODS The WATCHMAN Left Atrial Appendage System ( Atritech Inc. , Plymouth , Minnesota ) is a nitinol device implanted percutaneously to seal the LAA . Patients were followed by clinical and transesophageal echocardiography at 45 days and 6 months with annual clinical follow-up thereafter . RESULTS Sixty-six patients underwent device implantation . Mean follow-up was 740 + /- 341 days . At 45 days , 93 % ( 54 of 58 ) devices showed successful sealing of LAA according to protocol . Two patients experienced device embolization , both successfully retrieved percutaneously . No embolizations occurred in 53 patients enrolled after modification of fixation barbs . There were 2 cardiac tamponades , 1 air embolism , and 1 delivery wire fracture ( first generation ) with surgical explantation but no long-term sequelae for the patient . Four patients developed a flat thrombus layer on the device at 6 months that resolved with additional anticoagulation . Two patients experienced transient ischemic attack , 1 without visible thrombus . There were 2 deaths , neither device related . Autopsy documented a stable , fully endothelialized device 9 months after implantation . No strokes occurred during follow-up despite > 90 % of patients with discontinuation of anticoagulation . CONCLUSIONS Preliminary data suggest LAA occlusion with the WATCHMAN System to be safe and feasible . A r and omized study is ongoing comparing oral anticoagulation with percutaneous closure BACKGROUND Currently , 2 different left atrial appendage ( LAA ) closure systems are available for stroke prevention in nonvalvular atrial fibrillation but comparative data are lacking . OBJECTIVES To prospect ively compare procedural data and patient outcome for 2 contemporary LAA closure systems and to investigate an alternative antithrombotic treatment regimen in high-risk patients . METHODS Patients with nonvalvular atrial fibrillation , with high risk for stroke , and who either had contraindication or were not willing to accept oral anticoagulation were prospect ively enrolled . Watchman ( Boston Scientific , Natick , MA ; group A ) or Amplatzer Cardiac Plug ( St Jude Medical , Minneapolis , MN ; group B ) devices were implanted . All patients received antithrombotic therapy for 6 weeks . After repeat transesophageal echocardiography , patients were switched to aspirin . RESULTS Eighty patients were enrolled . There was no statistical difference in patient characteristics in groups A and B : CHA2DS2VASC score : 4.1 ± 1.5 versus 4.5 ± 1.8 ; HASBLED score : 3.1 ± 1.1 versus 3.1 ± 1.1 , respectively . LAA closure was achieved in 78 of 80 patients ( 98 % ) ( group A : 38 of 40 [ 95 % ] vs group B : 40 of 40 [ 100 % ] ) . There was no difference in procedure time ( group A : 48 ± 16 minutes vs group B : 47 ± 15 minutes ; P = .69 ) and fluoroscopy time ( group A : 6.0 ± 4.7 minutes vs group B : 7.3 ± 4.4 minutes ; P = .25 ) . Major complications included 1 air embolism and delayed tamponade in each group . After 6 weeks , 1 device dislodgment and 4 device-related thrombi were detected . Ninety-four percent of the patients ( 73 of 77 ) were switched to aspirin after 6 weeks . During a median follow-up of 364 days ( Q1-Q3 : 283 - 539 days ) , no systemic embolism occurred , but 3 patients died ( heart failure : n = 2 ; bleeding : n = 1 ) . CONCLUSIONS Implantation of both LAA closure devices can be performed with high success rates in high-risk patients . Postprocedural 6 weeks antithrombotic therapy followed by aspirin therapy needs to be confirmed in a larger study BACKGROUND Atrial fibrillation ( AF ) is the most common sustained cardiac arrhythmia and it is associated with an increased stroke risk , due mainly to cardiac embolism from the left atrial appendage ( LAA ) . Percutaneous LAA closure is a method to reduce stroke risk in AF without using anticoagulant agents . In this study we report data from an Italian experience with the LAA occluder Amplatzer Cardiac Plug ( ACP ) device ( Aga Medical Corporation , Plymouth , MN , USA ) . METHODS The study was design ed to evaluate the safety of LAA closure using ACP and the efficacy of the procedure in preventing strokes during a 1-year follow-up . Patients with permanent or paroxysmal AF , high stroke risk , and contraindication to warfarin therapy were selected for the procedure . RESULTS The LAA closure was attempted in 37 patients and succeeded in 34 cases ( 91.9 % ) . Four patients experienced serious complications ( one cardiac tamponade requiring pericardiocentesis , two device embolizations , one low-rate response AF requiring artificial pacing ) . During a 1-year follow-up , ischemic stroke occurred in one of 34 patients , result ing in a stroke rate of 2.94 % ; thus there was a stroke rate reduction of 50.2 % and 26.5 % compared to the expected stroke rate , according to CHADS2 and CHA2 DS2 VASc score . None of the patients who received ACP experienced major bleeding during the follow-up . CONCLUSION LAA closure using ACP is a relatively feasible procedure which can be performed by highly experienced operators to reduce stroke rate in patients with AF , high stroke risk , and contraindication to oral anticoagulants OBJECTIVES The purpose of this study was to assess the safety and efficacy of left atrial appendage ( LAA ) closure in nonvalvular atrial fibrillation ( AF ) patients ineligible for warfarin therapy . BACKGROUND The PROTECT AF ( Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation ) trial demonstrated that LAA closure with the Watchman device ( Boston Scientific , Natick , Massachusetts ) was noninferior to warfarin therapy . However , the PROTECT AF trial only included patients who were c and i date s for warfarin , and even patients r and omly assigned to the LAA closure arm received concomitant warfarin for 6 weeks after Watchman implantation . METHODS A multicenter , prospect i ve , nonr and omized study was conducted of LAA closure with the Watchman device in 150 patients with nonvalvular AF and CHADS₂ ( congestive heart failure , hypertension , age ≥75 years , diabetes mellitus
Output:
| Although superiority of LAAO over NOACs was not demonstrated by RCTs in terms of stroke prevention , LAAO was found to be consistently associated with a lower rate of both thromboembolic and hemorrhagic events as compared with NOACs in observational studies |
MS212287 | ***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: CONTEXT The worldwide epidemic of diabetes mellitus is increasing the burden of cardiovascular disease , the leading cause of death among persons with diabetes . The independent effect of diabetes on mortality following acute coronary syndromes ( ACS ) is uncertain . OBJECTIVE To evaluate the influence of diabetes on mortality following ACS using a large data base spanning the full spectrum of ACS . DESIGN , SETTING , AND PATIENTS A subgroup analysis of patients with diabetes enrolled in r and omized clinical trials that evaluated ACS therapies . Patients with ACS in 11 independent Thrombolysis in Myocardial Infa rct ion ( TIMI ) Study Group clinical trials from 1997 to 2006 were pooled , including 62,036 patients ( 46,577 with ST-segment elevation myocardial infa rct ion [ STEMI ] and 15,459 with unstable angina/non-STEMI [ UA/NSTEMI ] ) , of whom 10 613 ( 17.1 % ) had diabetes . A multivariable model was constructed to adjust for baseline characteristics , aspects of ACS presentation , and treatments for the ACS event . MAIN OUTCOME MEASURES Mortality at 30 days and 1 year following ACS among patients with diabetes vs patients without diabetes . RESULTS Mortality at 30 days was significantly higher among patients with diabetes than without diabetes presenting with UA/NSTEMI ( 2.1 % vs 1.1 % , P < .001 ) and STEMI ( 8.5 % vs 5.4 % , P < .001 ) . After adjusting for baseline characteristics and features and management of the ACS event , diabetes was independently associated with higher 30-day mortality after UA/NSTEMI ( odds ratio [ OR ] , 1.78 ; 95 % confidence interval [ CI ] , 1.24 - 2.56 ) or STEMI ( OR , 1.40 ; 95 % CI , 1.24 - 1.57 ) . Diabetes at presentation with ACS was associated with significantly higher mortality 1 year after UA/NSTEMI ( hazard ratio [ HR ] , 1.65 ; 95 % CI , 1.30 - 2.10 ) or STEMI ( HR , 1.22 ; 95 % CI , 1.08 - 1.38 ) . By 1 year following ACS , patients with diabetes presenting with UA/NSTEMI had a risk of death that approached patients without diabetes presenting with STEMI ( 7.2 % vs 8.1 % ) . CONCLUSION Despite modern therapies for ACS , diabetes confers a significant adverse prognosis , which highlights the importance of aggressive strategies to manage this high-risk population with unstable ischemic heart disease Background — The antiplatelet effects of the Platelet Inhibition and Patient Outcomes ( PLATO ) trial dose of ticagrelor in patients nonresponsive to clopidogrel and after they switch agents are unknown . Methods and Results — Patients with stable coronary artery disease on aspirin therapy received a 300-mg clopidogrel load ; nonresponders were identified by light transmittance aggregometry . In a 2-way crossover design , nonresponders ( n=41 ) and responders ( n=57 ) r and omly received clopidogrel ( 600 mg/75 mg once daily ) or ticagrelor ( 180 mg/90 mg twice daily ) for 14 days during period 1 . In period 2 , all nonresponders switched treatment ; half of the responders continued the same treatment , whereas the others switched treatment . Inhibition of platelet aggregation was higher in nonresponders treated with ticagrelor compared with clopidogrel ( P<0.05 ) . Treatment with ticagrelor among nonresponders result ed in a > 10 % , > 30 % , and > 50 % decrease in platelet aggregation from baseline in 100 % , 75 % , and 13 % of patients , respectively . Platelet aggregation fell from 59±9 % to 35±11 % in patients switched from clopidogrel to ticagrelor and increased from 36±14 % to 56±9 % in patients switched from ticagrelor to clopidogrel ( P<0.0001 for both ) . Platelet reactivity was below the cut points previously associated with ischemic risk measured by light transmittance aggregometry , VerifyNow P2Y12 assay , and vasodilator-stimulated phosphoprotein phosphorylation in 98 % to 100 % of patients after ticagrelor therapy versus 44 % to 76 % of patients after clopidogrel therapy . Conclusions — Ticagrelor therapy overcomes nonresponsiveness to clopidogrel , and its antiplatelet effect is the same in responders and nonresponders . Nearly all clopidogrel nonresponders and responders treated with ticagrelor will have platelet reactivity below the cut points associated with ischemic risk . Clinical Trial Registration — http://www . clinical trials.gov . Unique Identifier : NCT00642811 OBJECTIVE It has been postulated that prasugrel might be the preferred treatment option in diabetes mellitus ( DM ) patients with acute coronary syndrome ( ACS ) undergoing percutaneous coronary intervention ( PCI ) . We aim ed to compare the pharmacodynamic action of ticagrelor versus prasugrel . RESEARCH DESIGN AND METHODS In a prospect i ve , single-center , single-blind , crossover study , 30 consecutive ACS patients with DM who had been pretreated with clopidogrel were r and omized to either 90 mg ticagrelor twice daily or 10 mg prasugrel once daily with a 15-day treatment period . Platelet reactivity ( PR ) was assessed with the VerifyNow P2Y12 function assay , measured in P2Y12 reaction units ( PRU ) . RESULTS PR was significantly lower after ticagrelor ( 45.2 PRU [ 95 % CI 27.4–63.1 ] ) compared with prasugrel ( 80.8 PRU [ 63.0–98.7 ] ) , with a least squares mean difference of –35.6 PRU ( −55.2 to −15.9 , P = 0.001 ) . High PR rate was 0 % for ticagrelor and 3.3 % for prasugrel ( P = 1.0 ) . CONCLUSIONS In DM patients with ACS who had been pretreated with clopidogrel and who undergo PCI , ticagrelor achieves a significantly higher platelet inhibition than prasugrel . Both antiplatelet agents effectively treat high PR . The relevance of these findings to the clinical efficacy and safety of ticagrelor and prasugrel in DM patients needs further elucidation Aims Patients with diabetes mellitus ( DM ) have increased platelet reactivity and reduced platelet response to clopidogrel compared with patients without DM . Prasugrel , a more potent antiplatelet agent , is associated with greater reductions in ischaemic events compared with clopidogrel , particularly in patients with DM . The aim of this study was to perform serial pharmacodynamic assessment s of prasugrel with high-dose clopidogrel in patients with DM . Methods and results Optimizing anti-Platelet Therapy In diabetes MellitUS (OPTIMUS)-3 was a prospect i ve , r and omized , double-blind , crossover study in patients with type 2 DM and coronary artery disease ( CAD ) . Patients ( n= 35 ) were r and omly assigned to either prasugrel 60 mg loading dose (LD)/10 mg maintenance dose ( MD ) or clopidogrel 600 mg LD/150 mg MD over two 1-week treatment periods separated by a 2-week washout period . Platelet function was assessed by VerifyNow ® P2Y12 assay , light transmission aggregometry , and vasodilator-stimulated phosphoprotein phosphorylation at 0 , 1 , 4 , and 24 h and 7 days . Greater platelet inhibition by VerifyNow ® P2Y12 was achieved by prasugrel compared with clopidogrel at 4 h post-LD ( least squares mean , 89.3 vs. 27.7 % , P < 0.0001 ; primary endpoint ) . The difference in platelet inhibition between prasugrel and clopidogrel was significant from 1 h through 7 days ( P < 0.0001 ) . Similar results were obtained using all other platelet function measures . Prasugrel result ed in fewer poor responders at all time points irrespective of definition used . Conclusion In patients with type 2 DM and CAD , st and ard-dose prasugrel is associated with greater platelet inhibition and better response profiles during both the loading and maintenance periods when compared with double-dose clopidogrel . Clinical trial identifier : www . clinical trials.gov — In acute coronary syndromes ( ACS ) , a dual antiplatelet regimen with an adenosine diphosphate ( ADP ) receptor antagonist plus aspirin has become the cornerstone of treatment . The third-generation thienopyridine prasugrel and the cyclopentyl-triazolo-pyrimidine ticagrelor provide a greater , more rapid and consistent platelet inhibition compared to their predecessor clopidogrel . Based on their advantages over clopidogrel in two l and mark studies , both drugs received a class I recommendation for their use in ACS patients with and without ST segment elevation . Due to differences in ACS population s and conditions investigated , the relative merits of ticagrelor versus prasugrel in the treatment of ACS patients with planned invasive strategy can not be reliably estimated from independent trials . To date , no direct head-to-head comparison of ticagrelor and prasugrel in terms of clinical outcome exists . The aim of this multicenter , r and omized , open-label trial is to assess whether ticagrelor is superior to prasugrel in ACS patients with planned invasive strategy Background —Ticagrelor and prasugrel provide stronger platelet inhibition compared with clopidogrel . Direct pharmacodynamic comparison between them has not yet been reported in ST-segment – elevation myocardial infa rct ion patients . Methods and Results —In a prospect i ve , single-center , single-blind study , 55 out of 117 ( 47 % ) screened consecutive ST-segment – elevation myocardial infa rct ion patients undergoing primary percutaneous coronary intervention were r and omized to either ticagrelor 180 mg loading followed by 90 mg bid , or prasugrel 60 mg loading followed by 10 mg od for 5 days . Platelet reactivity ( PR ) was assessed with the VerifyNow P2Y12 function assay and the Multiplate Analyzer at 0 , 1 , 2 , 6 , 24 hours , and 5 days postr and omization . The primary end point , PR with VerifyNow at hour 1 , did not differ significantly between patients r and omized to ticagrelor versus prasugrel ( 257.3 P2Y12 reaction unit [ PRU ] , 95 % CI 230.8–283.8 versus 231.3 PRU , 95 % CI 205.3–257.4 ; P=0.2 ) . PR did not differ at 2 , 6 , and 24 hours , although at day 5 it was lower with ticagrelor than prasugrel ( 25.6 PRU , 95 % CI 12.3–38.9 versus 50.3 PRU , 95 % CI 36.4–64.1 ; P=0.01 ) . At hour 2 , high on-treatment PR rates ( cutoff 208 PRU ) were 46.2 % and 34.6 % for ticagrelor and prasugrel , respectively , decreased significantly thereafter , whereas did not differ significantly between the 2 agents at all the time points of the study . Conclusions —In patients with ST-segment – elevation myocardial infa rct ion undergoing primary percutaneous coronary intervention , both ticagrelor and prasugrel exhibit an initial delay in the onset of their antiplatelet action . Ticagrelor did not appear superior to prasugrel in reducing PR during the first 24 hours of ST-segment – elevation myocardial infa rct ion . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT01463163 BACKGROUND Patients ' responses to oral antiplatelet therapy are subject to variation . Bedside monitoring offers the opportunity to improve outcomes after coronary stenting by individualizing therapy . METHODS We r and omly assigned 2440 patients scheduled for coronary stenting at 38 centers to a strategy of platelet-function monitoring , with drug adjustment in patients who had a poor response to antiplatelet therapy , or to a conventional strategy without monitoring and drug adjustment . The primary end point was the composite of death , myocardial infa rct ion , stent thrombosis , stroke , or urgent revascularization 1 year after stent implantation . For patients in the monitoring group , the VerifyNow P2Y12 and aspirin point-of-care assays were used in the catheterization laboratory before stent implantation and in the outpatient clinic 2 to 4 weeks later . RESULTS In the monitoring group , high platelet reactivity in patients taking c
Output:
| This meta- analysis shows the addition of a P2Y12 inhibitor is superior to placebo , with a trend favouring the use of prasugrel in patients with diabetes with ACS , particularly those undergoing PCI |
MS212288 | ***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 determine the prevalence of amblyopia and refractive errors among 7 to 12-year-old primary school children in Tehran , Iran . Methods : This population -based cross-sectional study included 2,410 r and omly selected students . Visual acuity was tested using an E-chart on Yang vision tester . Refractive errors were measured by photorefractometry and cycloautorefraction . Strabismus was checked using cover test . Direct ophthalmoscopy was used to assess the anterior segment , lens opacities , red reflex and fundus . Functional amblyopia was defined as best corrected visual acuity ≤20/40 in one or both eyes with no anatomical problems . Results : Amblyopia was present in 2.3 % ( 95 % CI : 1.8 % to 2.9 % ) of participants with no difference between the genders . Amblyopic subjects were significantly younger than non-amblyopic children ( P=0.004 ) . Overall , 15.9 % of hyperopic and 5.9 % of myopic cases had amblyopia . The prevalence of hyperopia ≥+2.00D , myopia ≤-0.50D , astigmatism ≥0.75D , and anisometropia ( ≥1.00D ) was 3.5 % , 4.9 % , 22.6 % , and 3.9 % , respectively . With increasing age , the prevalence of myopia increased ( P<0.001 ) , that of hyperopia decreased ( P=0.007 ) , but astigmatism showed no change . Strabismus was found in 2.3 % of cases . Strabismus ( OR=17.9 ) and refractive errors , especially anisometropia ( OR=12.87 ) and hyperopia ( OR=11.87 ) , were important amblyogenic risk factors . Conclusion : The high prevalence of amblyopia in our subjects in comparison to developed countries reveals the necessity of timely and sensitive screening methods . Due to the high prevalence of amblyopia among children with refractive errors , particularly high hyperopia and anisometropia , provision of glasses should be specifically attended by parents and supported by the Ministry of Health and insurance organizations Purpose : Strabismus and anisometropia are the most common causes of amblyopia . It can be easily prevented or treated if detected early . With the changing socio-cultural-economic milieu of the society , the perspectives of strabismus in society are gradually changing but still adequate knowledge , awareness , and attitude of parents toward strabismus will help in preventing amblyopia and aid in the proper psychosocial adaptation of such children . This study aim ed to assess knowledge and attitude of parents toward children suffering from strabismus . Methods : A prospect i ve study was carried out from January 1 to February 29 , 2016 , through a structured question naire to assess the level of knowledge and attitude of parents of children suffering from strabismus . Results : One hundred and twenty parents of children with strabismus were interviewed through a question naire . Education level of 78 parents was less than graduation ( 60 % ) and of 42 parents ( 40 % ) was graduation or higher . The majority of the parents , i.e. , 116 ( 96.67 % ) were bothered due to strabismus . One hundred and one ( 84.17 % ) parents felt that their child 's strabismus was noticed by others during interaction . Seventy-four ( 61.67 % ) parents felt that their children will have difficulty in making friends . Ninety ( 75 % ) parents felt uncomfortable if someone asked something about their child 's strabismus . One hundred and ten ( 91.67 % ) parents considered strabismus as cosmetic stigma . Conclusion : Some parents , especially from the lower educated segment , had poor underst and ing of strabismus , thus result ing in late presentation and ineffective counter measures . The key to prevent strabismic amblyopia and its psychosocial impacts is to provide health education regarding strabismus PURPOSE To study the prevalence and causes of bilateral and unilateral blindness in an elderly urban Danish population . METHODS Data originated from a Danish epidemiologic cross-sectional r and om sample population eye survey conducted during the years 1986 - 1988 . The population consisted of 1,000 inhabitants aged 60 to 80 years in Copenhagen . The participants underwent an extensive ophthalmologic examination . A participation rate of 96.9 % was achieved . Any blindness was defined as best-corrected visual acuity ( VA ) worse than 0.05 ( the WHO criteria ) and VA of 0.1 or worse ( the National criteria ( NC ) of blindness ) . RESULTS The prevalence rates of bilateral and unilateral blindness were , respectively , 0.53 % and 3.38 % according to WHO , but 1.06 % and 4.44 % using NC . Bilateral blindness rose significantly with age ( p=0.02 ) . According to NC , age-related macular degeneration ( AMD ) was the leading cause of bilateral blindness , accounting for 60 % of all blind persons . Glaucoma , myopic macular degeneration , cataract and retinitis pigmentosa were jointly the second most common cause , each accounting for 10 % of all bilaterally blind persons . Diabetic retinopathy was not a cause of bilateral blindness . Amblyopia was the most frequent , AMD the second most frequent , and diabetic retinopathy was among the third most common cause of unilateral blindness accounting for , respectively , 28.60 % , 16.66 % and 9.52 % of all unilateral blindness . CONCLUSIONS Blindness was associated with increasing age . A calculation indicates that among Danes aged 60 to 80 years 7,736 are bilaterally blind and 35,503 suffer from unilateral blindness . This study highlights AMD as the most important cause OBJECTIVE To determine the prevalence of and factors associated with amblyopia in a rural Chinese population . DESIGN Population -based , cross-sectional study . PARTICIPANTS Six thous and eight hundred thirty Han Chinese aged 30 years or more , recruited from Yongnian County , H and an , Hebei Province , China . METHODS Thirteen villages in the Yongnian County of H and an were selected r and omly , and residents of these selected villages 30 years of age or older were invited to participate in the H and an Eye Study . Participants underwent a comprehensive eye examination , including st and ardized visual acuity ( VA ) tests using logarithm of the minimum angle of resolution charts . Prevalence rates were age- and gender-st and ardized to the 2000 China census . MAIN OUTCOME MEASURES The proportion of rural Chinese population aged 30 years or older with amblyopia . Unilateral amblyopia was diagnosed if best-corrected VA ( BCVA ) was 20/32 or worse in the amblyopic eye and was not attributable directly to any underlying structural abnormality of the eye or visual pathway . Bilateral amblyopia was diagnosed if BCVA was 20/32 or less in both eyes and if there was a history of form deprivation during the sensitive period of visual development , such as media opacities or high , uncorrected ametropia . RESULTS Amblyopia was diagnosed in 205 participants , with an age- and gender-adjusted prevalence of 2.8 % . Of these , 1.7 % were unilateral cases and 1.1 % were bilateral cases . Underlying causes included anisometropia ( 67.3 % ) , strabismus ( 5.4 % ) , mixed strabismus and anisometropia ( 4.4 % ) , visual deprivation ( 9.8 % ) , astigmatism association ( 9.8 % ) , and other ( 3.4 % ) . Of the amblyopia cases , 47.6 % were hypermetropic . CONCLUSIONS In this rural Chinese population , 2.8 % of adults 30 to 80 years of age had amblyopia , a prevalence rate broadly consistent with that of most other studies . One third of the cases were bilateral , and anisometropia was the most common cause of this condition Aim : To determine the prevalence of refractive errors among schoolchildren in urban and rural areas of Dezful County , Iran . Methods : In a cross-sectional study , using r and om cluster sampling , 5721 Dezful schoolchildren were selected from 39 clusters . The participants in the study totalled 5544 ; 3673 elementary and middle school students and 1871 high school students . For the former group , cycloplegic refraction and for the latter , non-cycloplegic refraction was tested . In all participants , uncorrected visual acuity and best corrected visual acuity were determined , and those with a visual acuity of 20/40 or worse , underwent a complete ophthalmic examination to determine the cause of visual impairment . A spherical equivalent of −0.5 diopter ( D ) or worse was defined as myopia , + 2.0 D or more was defined as hyperopia , and a cylinder refraction greater than 0.75 D was considered astigmatism . Results : The uncorrected visual acuity was 20/40 or worse in the better eye of 224 schoolchildren ( 3.8 % of participants ) . This figure ( percentage ) was 14 ( 0.03 % ) based on their best corrected visual acuity and 96 ( 1.7 % ) with their presenting vision . According to results of cycloplegic refraction , 3.4 % ( 95 % confidence interval ( CI ) , 2.5 to 4.4 ) of the primary and middle school students were myopic and 16.6 % ( 95 % CI , 13.6 to 19.7 ) were hyperopic . For high school students , these rates were 2.1 % ( 95 % CI , 0.7 to 3.5 ) and 33.0 % ( 95 % CI , 24.9 to 41.1 ) , respectively , with non-cycloplegic refraction . In the multivariate logistic regression for primary and middle school students , myopia was correlated with age ( p = 0.030 ) , and hyperopia was correlated with age ( p<0.001 ) and area of residence ( p = 0.007 ) . In high school students , hyperopia again showed a correlation with their area of residence ( p = 0.029 ) . Conclusion : The present study reveals the considerable prevalence rates of refractive errors among schoolchildren in Dezful County and the high rate of an unmet need for their correction . Although myopia is not very prevalent , the high rate of hyperopia in the studied population emphasises its need for attention Objective : To estimate the distribution and predictors of some common visual problems ( strabismus , amblyopia , hypermetropia ) within a population -based cohort of children at the age of 7 years . Methods : Children participating in a birth cohort study were examined by orthoptists who carried out cover/uncover , alternate cover , visual acuity and non-cycloplegic refraction tests . Prospect ively collected data on potential risk factors were available from the study . Results : Data were available for 7825 seven-year-old children . 2.3 % ( 95 % CI 2.0 % to 2.7 % ) had manifest strabismus , 3.6 % ( 95 % CI 3.3 % to 4.1 % ) had past/present amblyopia , and 4.8 % ( 95 % CI 4.4 % to 5.3 % ) were hypermetropic . Children from the lowest occupational social class background were 1.82 ( 95 % CI 1.03 % to 3.23 % ) times more likely to be hypermetropic than children from the highest social class . Amblyopia ( p = 0.089 ) and convergent strabismus ( p = 0.066 ) also tended to increase as social class decreased . Conclusions : Although strabismus has decreased in the UK , it and amblyopia remain common problems . Children from less advantaged background s were more at risk of hypermetropia and to a lesser extent of amblyopia and convergent strabismus . Children ’s eye-care services may need to take account of this socio-economic gradient in prevalence to avoid inequity in access to care Purpose : To determine the prevalence of amblyopia , anisometropia , and strabismus in schoolchildren of Shiraz , Iran . Material s and Methods : A r and om cluster sampling was used in a cross-sectional study on schoolchildren in Shiraz . Cycloplegic refraction was performed in elementary and middle school children and high school students had non-cylcoplegic refraction . Uncorrected visual acuity ( UCVA ) and best corrected visual acuity ( BCVA ) were recorded for each participant . Anisometropia was defined as spherical equivalent ( SE ) refraction difference 1.00D or more between two eyes . Amblyopia was distinguished as a reduction of BCVA to 20/30 or less in one eye or 2-line interocular optotype acuity differences in the absence of pathological causes . Cover test was performed for investigating of strabismus . Results : Mean age of 2638 schoolchildren was 12.5 years ( response rate = 86.06 % ) . Prevalence of anisometropia was 2.31 % ( 95 % confidence interval [ CI ] , 1.45 to 3.16 ) . 2.29 % of schoolchildren ( 95 % CI , 1.46 to 3.14 ) were amblyopic . The prevalence of amblyopia in boys and girls was 2.32 %
Output:
| Conclusions The prevalence of amblyopia in Iran is very different . |
MS212289 | ***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: Filariasis control programmes are moving towards a strategy of repeated single-dose mass treatment of endemic population s. Using a combination , such as albendazole ( ALB ) to diethylcarbamazine ( DEC ) gives both macrofilaricidal and anti-helmintic activity . However , the safety of the combination versus DEC alone should be established in field studies in large population s prior to incorporation into national programmes . The present study compared the safety , tolerability , and efficacy of single doses of DEC 6 mg/kg + ALB placebo with DEC 6 mg/kg + ALB 400 mg in population s living in two filariasis endemic villages in the district of Wardha in western India . The study was double blind , parallel group , and r and omized . Safety and tolerability study were studied in males and females older than 5 years . Safety was assessed by monitoring if adverse events ( AEs ) over 5 days affected daily acivities . Subjects in the 2 treatment groups experienced insignificantly different effects on daily activities and the combination was shown to be safe . Efficacy was evaluated by microfilaraemia ( Mf ) , immunochromatographic test ( ICT ) and ultrasonography ( USG ) at 0 , 3 , 6 , and 12 months of follow up . The efficacy study enrolled 103 male patients ( aged 18 - 50 years ) in microfilariae positive , clinical disease and asymptomatic , amicrofilaremic groups . There was no significant difference in efficacy between groups at 12 months . Within the Mf positive group , significant differences were seen in microfilaraemia ( P < 0.001 ) with both treatments , and in USG ( P < 0.001 and P < 0.004 respectively ) , at 12 months . The present field study has shown the combination of DEC + ALB to be as safe as the single drug DEC and thus the combination can be put in use in the national filariasis control programmes . Both drugs were adequately absorbed . The study at present does not provide evidence for the greater efficacy of the combination at 12 months follow up . While the safety of the combination has been ascertained , the incorporation or otherwise of ALB into national programmes for greater efficacy must await results of studies with longer follow up 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 This r and omized , placebo-controlled trial investigated the efficacy and nutritional benefit of combining chemotherapeutic treatment for intestinal helminths ( albendazole ) and lymphatic filariasis ( ivermectin ) . Children were infected with Ascaris ( 29.2 % ) , Trichuris ( 42.2 % ) , and hookworm ( 6.9 % ) , with 54.7 % of children having one or more of these parasites . Wuchereria bancrofti microfilaria were found in 13.3 % of the children . Children were r and omly assigned to treatment with placebo , albendazole , ivermectin , or combined therapy . Combination treatment reduced the prevalence of Trichuris infections significantly more than either drug alone . Combination therapy also significantly reduced the prevalence and density of W. bancrofti microfilaremia compared with placebo or ivermectin alone . Only combination therapy result ed in significantly greater gains in height ( hookworm-infected children ) or weight ( Trichuris-infected children ) compared with the placebo group . Combined albendazole and ivermectin was a more efficacious treatment for intestinal helminth and W. bancrofti infections in children and result ed in nutritional benefits not found with either drug alone Although current programmes to eliminate lymphatic filariasis have made significant progress it may be necessary to use different approaches to achieve the global goal , especially where compliance has been poor and ‘ hot spots ’ of continued infection exist . In the absence of alternative drugs , the use of higher or more frequent dosing with the existing drugs needs to be explored . We examined the effect of higher and /or more frequent dosing with albendazole with a fixed 300 mg dose of diethylcarbamazine in a Wuchereria bancrofti endemic area in Odisha , India . Following screening , 104 consenting adults were r and omly assigned to treatment with the st and ard regimen annually for 24 months ( S1 ) , or annually with increased dose ( 800 mg albendazole)(H1 ) or with increased frequency ( 6 monthly ) with either st and ard ( S2 ) or increased ( H2 ) dose . Pre-treatment microfilaria counts ( GM ) ranged from 348 to 459 mf/ml . Subjects were followed using microfilaria counts , OG4C3 antigen levels and ultrasound scanning for adult worm nests . Microfilarial counts tended to decrease more rapidly with higher or more frequent dosing at all time points . At 12 months , Mf clearance was marginally greater with the high dose regimens , while by 24 months , there was a trend to higher Mf clearance in the arm with increased frequency and 800 mg of albendazole ( 76.9 % ) compared to other arms , ( S1:64 % , S2:69.2 % & H1:73.1 % ) . Although higher and /or more frequent dosing showed a trend towards a greater decline in antigenemia and clearance of “ nests ” , all regimens demonstrated the potential macrofilaricidal effect of the combination . The higher doses of albendazole did not result in a greater number or more severe side effects . The alternative regimens could be useful in the later stages of existing elimination programmes or achieving elimination more rapidly in areas where programmes have yet to start Background Chronic parasitic infections are associated with active immunomodulation which may include by-st and er effects on unrelated antigens . It has been suggested that pre-natal exposure to parasitic infections in the mother impacts immunological development in the fetus and hence the offspring ’s response to vaccines , and that control of parasitic infection among pregnant women will therefore be beneficial . Methodology /Principal findings We used new data from the Entebbe Mother and Baby Study , a trial of anthelminthic treatment during pregnancy conducted in Ug and a , to further investigate this hypothesis . 2705 mothers were investigated for parasitic infections and then r and omised to albendazole ( 400 mg ) versus placebo and praziquantel ( 40mg/kg ) during pregnancy in a factorial design . All mothers received sulfadoxine/pyrimethamine for presumptive treatment of malaria . Offspring received Exp and ed Programme on Immunisation vaccines at birth , six , 10 and 14 weeks . New data on antibody levels to diphtheria toxin , three pertussis antigens , Haemophilus influenzae type B ( HiB ) and Hepatitis B , measured at one year ( April 2004 –May 2007 ) from 1379 infants were analysed for this report . Additional observational analyses relating maternal infections to infant vaccine responses were also conducted . Helminth infections were highly prevalent amongst mothers ( hookworm 43.1 % , Mansonella 20.9 % , Schistosoma mansoni 17.3 % , Strongyloides 11.7 % , Trichuris 8.1 % ) and 9.4 % had malaria at enrolment . In the trial analysis we found no overall effect of either anthelminthic intervention on the measured infant vaccine responses . In observational analyses , no species was associated with suppressed responses . Strongyloidiasis was associated with enhanced responses to pertussis toxin , HiB and Hep B vaccine antigens . Conclusions / Significance Our results do not support the hypothesis that routine anthelminthic treatment during pregnancy has a benefit for the infant ’s vaccine response , or that maternal helminth infection has a net suppressive effect on the offspring ’s response to vaccines . Trial Registration IS RCT N.com IS RCT The efficacy of two strategies for control of Bancroftian filariasis using selective rather than community-wide diethylcarbamazine ( DEC ) chemotherapy was evaluated and compared in two endemic communities of north-eastern Tanzania , with pretreatment microfilariae ( mf ) prevalences of 22 % and 38 % , and geometric mean intensities ( GMIs ) of 668 mf/ml and 735 mf/ml of blood . All mf-positive cases in the first community were offered treatment with 6 mg of DEC/kg of body weight a day for 12 days ( group 1 ) , and those in the second community were offered treatment with two doses of 6 mg of DEC/kg of body weight at an interval of six months ( group 2 ) . The effect of treatment was followed both among those treated and at the community level . In treated individuals , there was a rapid decrease in the mf load that was significantly greater among those receiving the 12-day st and ard dose . One year after the start of treatment , the mf clearance rates were 59 % and 39 % and the GMIs were reduced by 99 % and 97 % among treated individuals in groups 1 and 2 , respectively . However , at the community level , the mf prevalences were 16.3 % and 27.9 % ( reduced by 27 % and 26 % ) and the GMIs were 129 mf/ml and 224 mf/ml ( reduced by 81 % and 70 % ) one year after the start of treatment with the two regimens , respectively , suggesting that transmission continued at a significant level in the villages after treatment . The limitations of selective chemotherapy are discussed , and it is argued that strategies based on mass DEC chemotherapy would be more effective in reducing the microfilarial load in the community and thereby in reducing transmission Forty male Polynesian W. bancrofti carriers with mf counts greater than or equal to 20/ml were treated with a single ivermectin 50 , 100 , 150 or 200 mcg/kg dose . Following therapy , mf levels fell to less than 1 % of pretreatment levels in the carriers treated with the 3 highest doses . After one month , negativation rate was 40 % in patients treated with a 50 mcg/kg dose , significantly lower than in patients treated with higher doses . Recurrence of microfilaremia was observed by 3 months , mf recurrence percentages were significantly lower in patients treated with the 3 highest doses than in patients treated with a 50 mcg/kg dose . At 6 months , mf recurrence percentages reached 49.8 , 12.6 , 14 and 5.4 % of pretreatment levels in carriers treated with 50 , 100 , 150 and 200 mcg/kg , respectively . No significant difference was observed between mf levels by group at 6 and 12 months . With respect to efficacy , a dose greater than or equal to 100 mcg/kg appeared superior to 50 mcg/kg dose ; no significant difference between the 3 highest doses was observed . Some patients developed headache , myalgia and fever within 24 hours following therapy , none of adverse reactions were considered serious . In vector Ae . polynesiensis fed on carriers 6 months after treatment , average numbers of mf ingested and average numbers of L3 cephalic larvae were lower than those observed in mosquitoes fed on non-treated carriers with comparable mf counts . ( ABSTRACT TRUNCATED AT 250 WORDS Integrated chemotherapy of neglected tropical diseases ( NTD ) through mass drug administration given as a single dose would increase treatment coverage and cost-effectiveness . This study reports on the safety of a combination of albendazole , ivermectin and praziquantel in the treatment of lymphatic filariasis ( LF ) , schistosomiasis and soil-transmitted helminthiasis ( STH ) in infected children . In this r and omised , controlled , single-blinded clinical trial conducted in 235 primary school children aged 5 - 18 years in Yumbe District in Northern Ug and a , the triple combination therapy was compared with the current NTD programme regimen . Liver function testing was performed for all children who received combined therapy . The study included 48 children with LF alone , 60 children with schistosomiasis ( Schistosoma mansoni ) , 41 children with STH , 49 children with schistosomiasis + LF and 37 children with all three types of infection . Children were closely monitored by a paediatrician for any adverse reactions for 7 days . No serious adverse events were experienced . However , 4 of 18 children in the test group and 2 of 3 children in the control group who did not report any ill conditions before treatment developed adverse drug reactions . The combined and conventional therapies were found to be equally safe . The efficacies of both therapies were comparable and satisfactory . [ Clinical Trials.gov identifier : NCT01050517 ] Background Once interruption of transmission of lymphatic filariasis is achieved , morbidity prevention and management becomes more important . A study in Brugia malayi filariasis from India has shown sub- clinical lymphatic pathology with potential reversibility . We studied a Wuchereria bancrofti infected population , the major contributor to LF globally . Methods Children aged 5–18 years from Odisha , India were screened for W. bancrofti infection and disease . 102 infected children , 50 with filarial disease and 52 without symptoms were investigated by lymphoscintigraphy and then r and omized to receive a supervised single oral dose of DE
Output:
| For mf density there is no trend , with some trials reporting a greater reduction in mf density with albendazole and others a greater reduction with the control group .
This finding is consistent in trials evaluating albendazole alone , or added to DEC or ivermectin .
The review raises questions over whether albendazole has any important contribution to the elimination of lymphatic filariasis . |
MS212290 | ***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 Several controlled studies provide evidence that treatment with interferon beta in patients with a first event suggestive of multiple sclerosis ( MS ) delays conversion to clinical ly definite MS ( CDMS ) . Our aim was to determine whether early initiation of treatment with interferon beta prevents development of confirmed disability in MS . METHODS In the initial placebo-controlled phase of the double-blinded BENEFIT study , patients with a first event suggestive of MS and a minimum of two clinical ly silent lesions in MRI were r and omised to receive either interferon beta-1b 250 microg ( n=292 ) or placebo ( n=176 ) subcutaneously every other day for 2 years , or until diagnosis of CDMS . Patients were then eligible to enter the follow-up phase with open-label interferon beta-1b . In the current prospect ively planned analysis 3 years after r and omisation , the effects of early interferon beta-1b treatment were compared with those of delayed treatment initiated after diagnosis of CDMS or after 2 years on the study . The primary outcomes of this ITT analysis were time to diagnosis of CDMS , time to confirmed exp and ed disability status scale ( EDSS ) progression , and score on a patient-reported functional assessment scale ( FAMS-TOI ) . This trial is registered with Clinical Trials.gov , number NCT00185211 . FINDINGS Of the 468 patients originally r and omised , 418 ( 89 % ) entered the follow-up phase ; 392 ( 84 % ) completed 3 years ' post-r and omisation follow-up . After 3 years , 99 ( 37 % ) patients in the early group developed CDMS compared with 85 ( 51 % ) patients in the delayed treatment group . Early treatment reduced the risk of CDMS by 41 % ( hazard ratio 0.59 , 95 % CI 0.44 - 0.80 ; p=0.0011 ; absolute risk reduction 14 % ) compared with delayed treatment . Over 3 years , 42 ( 16 % ) patients in the early group and 40 ( 24 % ) in the delayed group had confirmed EDSS progression ; early treatment reduced the risk for progression of disability by 40 % compared with delayed treatment ( 0.60 , 0.39 - 0.92 ; p=0.022 ; absolute risk reduction 8 % ) . The FAMS-TOI score was high and stable in both groups over the 3-year period ( p=0.31 ) . INTERPRETATION Our data suggest that early initiation of treatment with interferon beta-1b prevents the development of confirmed disability , supporting its use after the first manifestation of relapsing-remitting MS Objective Early treatment following a first clinical demyelinating event ( FCDE ) delays further disease activity in patients with multiple sclerosis ( MS ) . This study determined the effects of early versus delayed treatment ( DT ) with subcutaneous interferon ( sc IFN ) β-1a 44 μg in patients with an FCDE up to 60 months postr and omisation . Methods Patients who completed the 24-month double-blind REFLEX ( REbif FLEXible dosing in early MS ) study entered an extension ( REFLEXION , REbif FLEXible dosing in early MS extensION ) : patients initially r and omised to sc IFN β-1a and not reaching clinical ly definite MS ( clinical ly definite MS , CDMS ( second attack or sustained Exp and ed Disability Status Scale ( EDSS ) score increase ) ) continued original treatment ( three times weekly ( tiw ) or once weekly ( qw ) ) ; placebo patients switched to tiw ( DT ) ; patients with CDMS switched to tiw . Clinical , MRI and adverse event data up to month 60 are reported . Results 402/517 ( 77.8 % ) REFLEX patients entered REFLEXION ( DT , n=133 ; tiw , n=127 ; qw , n=142 ) . At month 60 , cumulative probability of CDMS was : DT 44.6 % ; qw 40.7 % ( nominal p=0.084 vs DT ) ; tiw 39.2 % ( nominal p=0.032 vs DT ) . Cumulative probability of McDonald MS conversion ( CDMS or new MRI activity ) at month 60 was also reduced for tiw versus DT ( nominal p<0.001 ) . At month 60 , mean cumulative numbers of new T2 , gadolinium-enhancing and T1 hypointense lesions were lower with sc IFN β-1a qw ( nominal p<0.05 ) and tiw versus DT ( nominal p<0.001 ) ; T2 and T1 hypointense lesion volume change was lower for sc IFN β-1a tiw versus DT ( nominal p<0.01 ) . Treatment was well tolerated ; fewer patients receiving tiw versus qw were positive for neutralising or binding antibodies . Conclusions Over 5 years in patients presenting with an FCDE , early sc IFN β-1a tiw administration versus DT prolonged time to CDMS and McDonald MS , and reduced overall MRI activity . Trial registration number NCT00813709 ; Results BACKGROUND Several studies have confirmed the predictive value of baseline and follow-up magnetic resonance ( MR ) imaging variables for conversion to clinical ly definite multiple sclerosis ( CDMS ) , depending on the population , follow-up duration , and treatment intervention . However , the timing of follow-up imaging and the effect of treatment intervention on the predictive value of baseline MR imaging variables require further elucidation . OBJECTIVES To assess the prognostic value of baseline MR imaging variables for conversion to CDMS over 3 years and whether this was affected by treatment intervention and ( 2 ) to assess the increased risk for conversion posed by dissemination in time on follow-up MR imaging . DESIGN Cohort study . SETTING Multicenter r and omized clinical trial . PATIENTS Four hundred sixty-eight patients with a clinical ly isolated syndrome who had an initial clinical demyelinating event within the past 60 days who received early treatment ( 3 years of interferon beta-1b ) or delayed treatment ( placebo first , followed by > or = 1 year of interferon beta-1b ) . Intervention Magnetic resonance imaging . Main Outcome Measure Time to CDMS . RESULTS The overall conversion rate to CDMS was 42 % . Barkhof criteria with the strongest prognostic value were the presence at baseline of at least 9 T2-weighted lesions ( hazard ratio [ HR ] , 1.64 ; 95 % confidence interval [ CI ] , 1.15 - 2.33 ; P = .006 ) and at least 3 periventricular lesions ( 1.66 ; 1.14 - 2.41 ; P = .009 ) . No specific advantage was noted in using a fixed cutoff of at least 3 Barkhof criteria ( HR , 1.31 ; 95 % CI , 0.95 - 1.79 ; P = .10 ) . The prognostic value of all MR imaging criteria was unaffected by treatment intervention ( P > or = .20 for all ) . Dissemination in time result ed in increased risk for CDMS only in patients without dissemination in space at baseline and was most informative at the 9-month MR imaging ( HR , 2.72 ; 95 % CI , 1.26 - 5.87 ; P = .01 ) . CONCLUSIONS The modified Barkhof criteria showed moderate predictive value for conversion to CDMS , although all patients had received interferon beta-1b therapy for at least 1 year . The predictive value was unaffected by treatment intervention . Follow-up MR imaging was most informative after 9 months in patients without dissemination in space at baseline Objective To examine the long-term impact of early treatment initiation of interferon beta-1b ( IFNB1b , Betaferon/Betaseron ) in patients with a first event suggestive of multiple sclerosis ( MS ) . Methods In the original placebo-controlled phase of BENEFIT , patients were r and omised to IFNB1b 250 μg or placebo subcutaneously every other day . After 2 years or diagnosis of clinical ly definite MS ( CDMS ) , all patients were offered open-label IFNB1b treatment for a maximum duration of 5 years . Thereafter , patients were enrolled in an observational extension study for up to 8.7 years . Results Of the initial 468 patients , 284 ( 60.7 % ; IFNB1b : 178 ( 61.0 % of the original arm ) , placebo : 106 ( 60.2 % of original arm ) ) were enrolled in the extension study . 94.2 % of patients were receiving IFNB1b . Patients originally r and omised to IFNB1b had a reduced risk of developing CDMS by 32.2 % over the 8-year observation period ( HR 0.678 ; 95 % CI 0.525 to 0.875 ; p=0.0030 ) , a longer median time to CDMS by 1345 days ( 95 % CI 389 to 2301 ) , and a lower annualised relapse rate ( 0.196 ( 95 % CI 0.176 to 0.218 ) versus 0.255 ( 95 % CI 0.226 to 0.287 ) , p=0.0012 ) , with differences mainly emerging in the first year of the study . Cognitive outcomes remained higher in the early treated patients . EDSS remained low over time with a median of 1.5 in both arms . Conclusions These 8-year results provide further evidence supporting early initiation of treatment with IFNB1b in patients with a first event suggestive of MS BACKGROUND Cladribine provides immunomodulation through selective targeting of lymphocyte subtypes . We report the results of a 96-week phase 3 trial of a short-course oral tablet therapy in patients with relapsing-remitting multiple sclerosis . METHODS We r and omly assigned 1326 patients in an approximate 1:1:1 ratio to receive one of two cumulative doses of cladribine tablets ( either 3.5 mg or 5.25 mg per kilogram of body weight ) or matching placebo , given in two or four short courses for the first 48 weeks , then in two short courses starting at week 48 and week 52 ( for a total of 8 to 20 days per year ) . The primary end point was the rate of relapse at 96 weeks . RESULTS Among patients who received cladribine tablets ( either 3.5 mg or 5.25 mg per kilogram ) , there was a significantly lower annualized rate of relapse than in the placebo group ( 0.14 and 0.15 , respectively , vs. 0.33 ; P<0.001 for both comparisons ) , a higher relapse-free rate ( 79.7 % and 78.9 % , respectively , vs. 60.9 % ; P<0.001 for both comparisons ) , a lower risk of 3-month sustained progression of disability ( hazard ratio for the 3.5-mg group , 0.67 ; 95 % confidence interval [ CI ] , 0.48 to 0.93 ; P=0.02 ; and hazard ratio for the 5.25-mg group , 0.69 ; 95 % CI , 0.49 to 0.96 ; P=0.03 ) , and significant reductions in the brain lesion count on magnetic resonance imaging ( MRI ) ( P<0.001 for all comparisons ) . Adverse events that were more frequent in the cladribine groups included lymphocytopenia ( 21.6 % in the 3.5-mg group and 31.5 % in the 5.25-mg group , vs. 1.8 % ) and herpes zoster ( 8 patients and 12 patients , respectively , vs. no patients ) . CONCLUSIONS Treatment with cladribine tablets significantly reduced relapse rates , the risk of disability progression , and MRI measures of disease activity at 96 weeks . The benefits need to be weighed against the risks . ( Clinical Trials.gov number , NCT00213135 . Natural history studies have identified factors that predict evolution to multiple sclerosis or risk of disability accumulation over time . Although these studies are based on large multicentre cohorts with long follow-ups , they have limitations such as lack of st and ardized protocol s , a retrospective data collection or lack of a systematic magnetic resonance imaging acquisition and analysis protocol , often result ing in failure to take magnetic resonance and oligoclonal b and s into account as joint covariates in the prediction models . To overcome some of these limitations , the aim of our study was to identify and stratify baseline demographic , clinical , radiological and biological characteristics that might predict multiple sclerosis development and disability accumulation using a multivariate approach based on a large prospect i ve cohort of patients with clinical ly isolated syndromes . From 1995 to 2013 , 1058 patients with clinical ly isolated syndromes were included . We evaluated the influence of baseline prognostic factors on the risk for developing clinical ly definite multiple sclerosis , McDonald multiple sclerosis , and disability accumulation ( Exp and ed Disability Status Scale score of 3.0 ) based on univariate ( hazard ratio with 95 % confidence intervals ) and multivariate ( adjusted hazard ratio with 95 % confidence intervals ) Cox regression models . We ultimately included 1015 patients followed for a mean of 81 ( st and ard deviation = 57 ) months . Female/male ratio was 2.1 . Females exhibited a similar risk of conversion to multiple sclerosis
Output:
| We found no differences between the included drugs with respect to the hazard of conversion to CDMS .
Very low- quality evidence suggests a small and uncertain benefit with early treatment compared with placebo in reducing disability-worsening and relapses .
The advantage of early treatment compared with delayed on disability-worsening was heterogeneous depending on the actual drug used and based on very low- quality evidence .
Low- quality evidence suggests that the chances of relapse are less with early treatment compared with delayed .
Early treatment reduced the hazard of conversion to CDMS compared either with placebo , no treatment or delayed treatment , both in short- and long-term follow-up .
Low- quality evidence suggests that early treatment is associated with fewer participants with at least one serious AE compared with placebo .
Very low- quality evidence suggests that , compared with placebo , early treatment leads to more withdrawals or treatment discontinuation due to AEs . |
MS212291 | ***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 This r and omized controlled study evaluated the efficacy of intravenous patient-controlled analgesia ( IV-PCA ) with fentanyl and ketorolac for neurosurgical patients , and compared the effectiveness of IV-PCA with intermittent analgesics injection . Methods The patients undergoing craniotomy were r and omly assigned to two groups . Patients of group P ( n = 53 ) received fentanyl ( 0.2 µg/kg/hr ) and ketorolac ( 0.3 mg/kg/hr ) via IV-PCA , and those of group N ( n = 53 ) received intermittent fentanyl or ketorolac injection as needed . Pain was evaluated using a 0 - 10 visual analogue scale ( VAS ) at postoperative 1 , 4 , and 24 hr . The amount of infused analgesic drugs , Glasgow Coma Scale ( GCS ) score , systolic arterial pressure , heart rate , respiratory rate , and the incidence of nausea and miosis were measured at the same time points . Results Although VAS of pain ( VASp ) was comparable at postoperative 1 hr ( P = 0.168 ) between the two groups , the group P had significantly lower VASp at postoperative 4 hr ( P = 0.007 ) and 24 hr ( P = 0.017 ) . In group P , less analgesic drugs were administered at postoperative 1 hr , and more analgesic drugs were administered at postoperative 24 hr . There were no differences between two groups with respect to nausea , GCS , systolic arterial pressure , and heart rate . IV-PCA did not further incur respiratory depression or miosis . Conclusions IV-PCA with fentanyl and ketorolac after craniotomy is more effective analgesic technique , without adverse events , than the intermittent administration of analgesics OBJECTIVE Postcraniotomy headache causes considerable pain and can be difficult to treat . We therefore tested the hypothesis that a single 100-mg preoperative dose of diclofenac reduces the intensity of postcraniotomy headache , and reduces analgesic requirements . METHODS 200 patients having elective craniotomies were r and omly assigned to diclofenac ( n = 100 ) or control ( n = 100 ) . Pain severity was assessed by an independent observer using a 10-cm-long visual analog scale the evening of surgery , and on the 1st and 5th postoperative days . Analgesics given during the first five postoperative days were converted to intramuscular morphine equivalents . Results were compared using Mann-Whitney-tests ; P < 0.05 was considered statistically significant . RESULTS Baseline and surgical characteristics were comparable in the diclofenac and control groups . Visual analog pain scores were slightly , but significantly lower with diclofenac at all times ( means and 95 % confidence intervals ) : the evening of surgery , 2.47 ( 1.8 - 3.1 ) vs. 4 . 37 ( 5.0 - 3.7 ) , ( P < 0.001 ) ; first postoperative day , 3.98 ( 3.4 - 4.6 ) vs. 5.6 ( 4.9 - 6.2 ) cm ( P < 0.001 ) and 5th postoperative day : 2.8 ( 2.2 - 3.4 ) vs. 4.0 ± ( 3.3 - 4.7 ) cm ( P = 0.013 ) . Diclofenac reduced systemic analgesic requirements over the initial five postoperative days ( mean and 95 % CI ) : 3.3 ( 2.6 - 3.9 ) vs. 4.3 ( 3.5 - 5.1 ) mg morphine equivalents ( P < 0.05 ) . CONCLUSIONS Preoperative diclofenac administration reduces postcraniotomy headache and postoperative analgesic requirements - a benefit that persisted throughout five postoperative days Introduction Acute pain is common during the endotracheal extubation period , and is related to complications and adverse outcomes . Patients with delayed extubation after craniotomy are vulnerable to pain and complications of extubation . However , pain control during extubation is still inadequate . Remifentanil , a new opioid with rapid onset and short duration of action , provides adequate analgesia during procedures with minimal effect of respiratory depression . Methods and analysis The study is a prospect i ve , r and omised , double-blinded , controlled parallel-group design . Patients with delayed extubation after intracranial surgery are screened daily . Adult patients ready for extubation are enrolled and assigned r and omly to one of the two treatment study groups , labelled as the ‘ Remi group ’ or ‘ Saline group ’ . Patients in the Remi group receive an intravenous bolus dose of remifentanil 0.5 μg/kg over 60 s followed by a continuous infusion 0.05 μg/kg/min for 20 min . Patients in the Saline group receive an intravenous infusion of 0.9 % sodium chloride at a volume and rate equal to that of remifentanil . Pain intensity is measured by the visual analogue scale ( VAS ) pain score . Adverse events during drug infusion are documented and reported . Patients will be followed up until hospital discharge , death or 60 days after the trial intervention on a first come , first served basis . Details of the incidence of reintubation and reoperation within 72 h after extubation , length of stay in the intensive care unit and hospital and mortality are collected . The primary end point is the incidence of severe pain ( defined as a VAS pain score more than 5 cm ) during the periextubation period ( defined as the period of time from immediately before extubation to 20 min after extubation ) . Ethics and dissemination The study was approved by the Institutional Review Board ( IRB ) of the Beijing Tiantan Hospital , Capital Medical University . The study findings will be disseminated through peer- review ed publications and conference presentations . Trial registration number Clinical Trials ( NCT ) : ChiCTR-PRC-13003879 Background : Gender differences in access to high quality care for chronic illnesses have been suggested yet little work in this potentially vital area of health care ine quality has been undertaken in Africa . We explored the influence of patient gender on the care of people with diabetes within a multi- method , national study of diabetes management in primary care in Tunisia . Methods : Method ologies used were quantitative ( nationwide r and omized study of 2160 medical records ) and qualitative ( participant observation , focus groups and interviews of patients and health care professionals ) . Results : Differences in patient characteristics , treatments prescribed , process and outcome data and access to care variables were demonstrated . The most striking disparity found was the high female to male ratio of patients attending for diabetes care ( 61.1 % ) . A number of possible explanations for this emerged : Men were thought to under-attend for practical , financial and behavioural reasons whereas women were thought to have increased morbidity and potentially over-attend for social and psychological reasons . Conclusion : We have demonstrated a number of disparities in the care of men and women with diabetes in Tunisian primary care . In particular , a dual but related problem emerges from the data : more women than men attend for diabetes care and yet women do not get the same level of risk factor control as men . A number of local explanations for these disparities have emerged , which inform our analysis of the impact of gendered beliefs on diabetes care . Strategies to address these disparities will require a careful consideration of local beliefs and practice Context : Scalp infiltration and scalp block are being used to manage postcraniotomy pain . Dexmedetomidine has been successfully used as an adjuvant in regional anesthesia . The study was intended to compare whether addition of dexmedetomidine prolonged the duration of analgesia as well as to compare the two techniques . Aims : The primary objective was to assess whether addition of dexmedetomidine to bupivacaine prolonged the duration of analgesia . The secondary objective was to compare between scalp nerve block and scalp infiltration as techniques for pain relief . Setting s and Design : The r and omized control study was conducted in a tertiary care center from November 2013 to October 2014 . Material s and Methods : A total of 150 American Society of Anesthesiologists Physical Status I – II patients , aged 18–70 years undergoing elective craniotomy were included . Patients were r and omized into three groups of 50 patients , i.e. , Group BI ( bupivacaine infiltration ) , Group BDI ( bupivacaine and dexmedetomidine infiltration ) , and Group BDNB ( bupivacaine and dexmedetomidine scalp nerve block ) . Patient 's pain score , pain-free interval , rescue analgesic requirement , and hemodynamic and respiratory parameters were noted for 48 h. Patients were followed up at 1 and 3 months to assess postcraniotomy pain . Results : Pain-free period was significantly longer in Group BDNB than Groups BDI and BI ( P < 0.0001 ) and pain control was better in dexmedetomidine containing groups than in bupivacaine group ( BI ) ( P < 0.0001 ) . The rescue analgesic requirement was significantly lower in Group BDNB and Group BDI compared to Group BI . Conclusion : The addition of dexmedetomidine ( 1 μg/kg ) to bupivacaine prolonged the pain-free period . Scalp nerve block is a superior technique than scalp infiltration Context A clear preference for intravenous or inhalational anaesthesia has not been established for craniotomy in patients without signs of cerebral hypertension . Objectives The NeuroMorfeo trial was design ed to test equivalence of inhalational and intravenous anaesthesia maintenance techniques in the postoperative recovery of patients undergoing elective supratentorial surgery . Design This trial is a multicentre , r and omised , open-label , equivalence design . A balanced stratified r and omisation scheme was maintained using a central ised r and omisation service . Equivalence was tested using the two one-sided tests procedure . Setting Fourteen Italian neuroanaesthesia centres participated in the study from December 2007 to March 2009 . Patients Adults , 18 to 75 years old , scheduled for elective supratentorial intracranial surgery under general anaesthesia were eligible for enrolment if they had a normal preoperative level of consciousness and no clinical signs of intracranial hypertension . Interventions Patients were r and omised to one of three anaesthesia maintenance protocol s to determine if sevoflurane – remifentanil or sevoflurane – fentanyl were equivalent to propofol – remifentanil . Main outcome measures The primary outcome was the time to achieve an Aldrete postanaesthesia score of at least 9 after tracheal extubation . Secondary endpoints included haemodynamic parameters , quality of the surgical field , perioperative neuroendocrine stress responses and routine postoperative assessment s. Results Four hundred and eleven patients [ 51 % men , mean age 54.8 ( SD 13.3 ) years ] were enrolled . Primary outcome data were available for 380 . Median ( interquartiles ) times to reach an Aldrete score of at least 9 were 3.48 ( 2.02 to 7.56 ) , 3.25 ( 1.21 to 6.45 ) and 3.32 min ( 1.40 to 8.33 ) for sevoflurane – fentanyl , sevoflurane – remifentanil and propofol – remifentanil anaesthesia respectively , which confirmed equivalence using the two one-sided tests approach . Between-treatment differences in haemodynamic variables were small and not clinical ly relevant . Urinary catecholamine and cortisol responses had significantly lower activation with propofol – remifentanil . Postoperative pain and analgesic requirements were significantly higher in the remifentanil groups . Conclusion Equivalence was shown for inhalational and intravenous maintenance anaesthesia in times to reach an Aldrete score of at least 9 after tracheal extubation . Haemodynamic variables , the quality of surgical field and postoperative assessment s were also similar . Perioperative endocrine stress responses were significantly blunted with propofol – remifentanil and higher analgesic requirements were recorded in the remifentanil groups . Trial registration : Eudract 2007–005279 - 32 BACKGROUND Pain after craniotomy is often under-treated . Opiates carry distinct disadvantages . Non-steroidal anti-inflammatory drugs have an anti-platelet action and carry a bleeding risk . Cyclo-oxygenase 2 inhibitors such as parecoxib are not associated with a bleeding risk and would be welcome analgesics if shown to be effective . METHODS In a prospect i ve double-blind , r and omized , placebo-controlled study , we investigated the analgesic effect of a single dose of parecoxib 40 mg given at dural closure in 82 patients undergoing elective craniotomies . Remifentanil was used intraoperatively , and i.v . morphine was titrated to the requirement in the post-anaesthetic unit . On the ward , i.m . morphine 5 mg as required and regular acetaminophen was prescribed . Morphine use and visual analogue pain scores were recorded at 1 , 6 , 12 , and 24 h after surgery . RESULTS Parecoxib reduced pain scores at 6 h and morphine use at 6 and 12 h after operation . However , overall , it had only minimal impact on postoperative
Output:
| There is high- quality evidence that NSAIDs reduce pain up to 24 hours postoperatively .
There is low- quality evidence that scalp blocks and dexmedetomidine may reduce additional analgesics requirements . |
MS212292 | ***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 Systematic monitoring of sedation , pain and delirium in the ICU is of paramount importance in delivering adequate patient care . While the use of systematic monitoring instruments is widely agreed upon , these tools are infrequently implemented into daily ICU care . The aim of this study is to compare the effectiveness of two different training strategies ( training according to the local st and ard vs. modified extended method ) on the implementation rate of scoring instruments on the ICU . Methods In this experimental cohort study we analyzed the frequency of scoring on three surgical ICUs before and after training , and in a 1 year follow-up . A modified extended training included establishing a local support team helping to resolve immediate problems . In addition we evaluated the impact on patients ’ outcome . Results ICUs trained by the modified extended method showed increased documentation rates of all scores per patient and day . In a 1 year follow-up , increased scoring rates for all scores were maintained . Scoring rates with training according to the local st and ard training protocol did not increase significantly . Implementation of delirium and pain monitoring were associated with a decrease in mortality [ odds ratio ( OR ) 0.451 ; 95 % confidence interval ( CI ) : 0.22–0.924 , and , respectively , OR 0.348 ; 95 % CI : 0.140–0.863 ] . Monitoring had no significant influence on ventilation time or ICU length of stay . Conclusions A modified extended training strategy for ICU monitoring tools ( sedation , pain , delirium ) leads to higher intermediate and long-term implementation rates and is associated with improved patient outcome . However , these findings may have been biased by unmeasured confounders Recent studies suggest that delirium is associated with risk of dementia and also acceleration of decline in existing dementia . However , previous studies may have been confounded by incomplete ascertainment of cognitive status at baseline . Herein , we used a true population sample to determine if delirium is a risk factor for incident dementia and cognitive decline . We also examined the effect of delirium at the pathological level by determining associations between dementia and neuropathological markers of dementia in patients with and without a history of delirium . The Vantaa 85 + study examined 553 individuals ( 92 % of those eligible ) aged ≥85 years at baseline , 3 , 5 , 8 and 10 years . Brain autopsy was performed in 52 % . Fixed and r and om-effects regression models were used to assess associations between ( i ) delirium and incident dementia and ( ii ) decline in Mini-Mental State Examination scores in the whole group . The relationship between dementia and common neuropathological markers ( Alzheimer-type , infa rcts and Lewy-body ) was modelled , stratified by history of delirium . Delirium increased the risk of incident dementia ( odds ratio 8.7 , 95 % confidence interval 2.1–35 ) . Delirium was also associated with worsening dementia severity ( odds ratio 3.1 , 95 % confidence interval 1.5–6.3 ) as well as deterioration in global function score ( odds ratio 2.8 , 95 % confidence interval 1.4–5.5 ) . In the whole study population , delirium was associated with loss of 1.0 more Mini-Mental State Examination points per year ( 95 % confidence interval 0.11–1.89 ) than those with no history of delirium . In individuals with dementia and no history of delirium ( n = 232 ) , all pathologies were significantly associated with dementia . However , in individuals with delirium and dementia ( n = 58 ) , no relationship between dementia and these markers was found . For example , higher Braak stage was associated with dementia when no history of delirium ( odds ratio 2.0 , 95 % confidence interval 1.1–3.5 , P = 0.02 ) , but in those with a history of delirium , there was no significant relationship ( odds ratio 1.2 , 95 % confidence interval 0.2–6.7 , P = 0.85 ) . This trend for odds ratios to be closer to unity in the delirium and dementia group was observed for neuritic amyloid , apolipoprotein ε status , presence of infa rcts , α-synucleinopathy and neuronal loss in substantia nigra . These findings are the first to demonstrate in a true population study that delirium is a strong risk factor for incident dementia and cognitive decline in the oldest-old . However , in this study , the relationship did not appear to be mediated by classical neuropathologies associated with dementia Objective : To study the outcome of delirium in elderly hip surgery patients . Design : Prospect i ve matched controlled cohort study . Hip surgery patients ( n = 112 ) aged 70 years and older , who participated in a controlled clinical trial of haloperidol prophylaxis for delirium , were followed for an average of 30 months after discharge . Patients with a diagnosis of dementia or mild cognitive impairment ( MCI ) were identified using psychiatric interviews . Proportions of patients with dementia/MCI were compared across patients who had postoperative delirium and selected control patients matched for preoperatively assessed risk factors who had not developed delirium during index hospitalization . Other outcomes were mortality rate and rate of institutionalization . Results : During the follow-up period , 54.9 % of delirium patients had died compared to 34.1 % of the controls ( relative risk = 1.6 , 95 % CI = 1.0–2.6 ) . Dementia or MCI was diagnosed in 77.8 % of the surviving patients with postoperative delirium and in 40.9 % of control patients ( relative risk = 1.9 , 95 % CI = 1.1–3.3 ) . Half of the patients with delirium were institutionalized at follow-up compared to 28.6 % of the controls ( relative risk = 1.8 , 95 % CI = 0.9–3.4 ) . Conclusion : The risk of dementia or MCI at follow-up is almost doubled in elderly hip surgery patients with postoperative delirium compared with at-risk patients without delirium . Delirium may indicate underlying dementia BACKGROUND International guidelines recommend systematic assessment of pain , agitation/sedation and delirium with vali date d scales for all ICU patients . However , these evaluations are often not done . We have created an e-learning training platform for the continuous medical education , and assessed its efficacy in increasing the use of vali date d tools by all medical and nursing staff of the participating ICUs during their daily practice . METHODS Multicenter , r and omized , before and after study . The eight participating centers were r and omized in two groups , and received training at different times . The use of vali date d tools ( Verbal Numeric Rating or Behavioral Pain Scale for pain ; Richmond Agitation-Sedation Scale for agitation ; Confusion Assessment Method for the ICU for delirium ) was evaluated from clinical data recorded in medical charts during a week , with follow-up up to six months after the training . All the operators were invited to complete a question naire , at baseline and after the training . RESULTS Among the 374 nurses and physicians involved , 140 ( 37.4 % ) completed at least one of the three courses . The assessment of pain ( 38.1 vs. 92.9 % , P<0.01 ) and delirium ( 0 vs. 78.6 % , P<0.01 ) using vali date d tools significantly increased after training . Observation in the follow-up showed further improvement in delirium monitoring , with no signs of extinction for pain and sedation/agitation measurements . CONCLUSIONS This e-learning program shows encouraging effectiveness , and the increase in the use of vali date d tools for neurological monitoring in critically ill patients lasts over time Background Delirium , a common problem among hospitalized elderly patients , is not usually diagnosed by doctors for various reasons . The primary aim of this study was to evaluate the effect of a short training course on the identification of delirium and the diagnostic rate of delirium among hospitalized patients aged ≥65 years . The secondary aim was to identify the risk factors for delirium . Methods A prospect i ve study was conducted in an acute-care hospital in Moscow , Russia . Six doctors underwent a short training course on delirium . Data collected included assessment by the confusion assessment method for the intensive care units , sociodemographic data , functional state before hospitalization , comorbidity , and hospitalization indices ( indication for hospitalization , stay in intensive care unit , results of laboratory tests , length of hospitalization , and in-hospital mortality ) . Results Delirium was diagnosed in 13 of 181 patients ( 7.2 % ) who underwent assessment . Cognitive impairment was diagnosed more among patients with delirium ( 30.0 % vs 6.1 % , P=0.029 ) ; Charlson comorbidity index was higher ( 3.6±2.4 vs 2.3±1.8 , P=0.013 ) ; and Barthel index was lower ( 43.5±34.5 vs 94.1±17.0 , P=0.000 ) . The length of hospitalization was longer for patients with delirium at 13.9±7.3 vs 8.8±4.6 days ( P=0.0001 ) , and two of the 13 patients with delirium died during hospitalization compared with none of the 168 patients without delirium ( P=0.0001 ) . Conclusion Although the rate of delirium was relatively low compared with studies from the West , this study proves that an educational intervention among doctors can bring about a significant change in the diagnosis of the condition This study investigates the relationships between delirium , cognitive impairment and acute illness severity with adverse clinical outcomes ; in-hospital mortality , hospital length of stay , or new entry to a care home . It is a prospect i ve observational study of medical in patients 70 years or older , with repeated measurements of cognition , delirium status , delirium severity , and severity of physical illness every 3 days until the 18th day and then the 28th day of hospitalization . Of 94 participants , 33 had delirium and 14 recovered during their hospitalization . Predictor variables for recovery were initial Mini Mental State Examination ( MMSE ) ( p=0.003 ) and severity of delirium at second assessment ( p=0.02 ) , for mortality initial MMSE ( p=0.002 ) and for discharge to care home were initial delirium status ( p=0.008 ) and age ( p=0.004 ) . Delirious people newly discharged to care homes stayed longer in hospital than those discharged to their previous address ( p=0.016 ) . We conclude that delirium is not a transient disorder . The presence of delirium was not related to measures of the severity of physical illness or disability . High mortality was associated with delirium but was specifically associated with cognitive impairment . Prolonged length of stay of delirious people may depend on discharge destination Background and aims : Delirium is a common postoperative complication in elderly patients which has a serious impact on outcome in terms of morbidity and costs . We examined whether a postoperative multi-factorial intervention program can reduce delirium and improve outcome in patients with femoral neck fractures . Methods : One hundred and ninety-nine patients , aged 70 years and over ( mean age±SD , 82±6 , 74 % women ) , were r and omly assigned to postoperative care in a specialized geriatric ward or a conventional orthopedic ward . The intervention consisted of staff education focusing on the assessment , prevention and treatment of delirium and associated complications . The staff worked as a team , applying comprehensive geriatric assessment , management and rehabilitation . Patients were assessed using the Mini Mental State Examination and the Organic Brain Syndrome Scale , and delirium was diagnosed according to DSM-IV criteria . Results : The number of days of postoperative delirium among intervention patients was fewer ( 5.0±7.1 days vs 10.2±13.3 days , p=0.009 ) compared with controls . A lower proportion of intervention patients were delirious postoperatively than controls ( 56/102 , 54.9 % vs 73/97 , 75.3 % , p=0.003 ) . Eighteen percent in the intervention ward and 52 % of controls were delirious after the seventh postoperative day ( p<0.001 ) . Intervention patients suffered from fewer complications , such as decubitus ulcers , urinary tract infections , nutritional complications , sleeping problems and falls , than controls . Total postoperative hospitalization was shorter in the intervention ward ( 28.0±17.9 days vs 38.0±40.6 days , p=0.028 ) . Conclusions : Patients with postoperative delirium can be successfully treated , result ing in fewer days of delirium , fewer other complications , and shorter length of hospitalization Delirium is a significant problem for older hospitalized people and is associated with poor outcomes . It is poorly recognized and evidence suggests that a major reason is lack of education . Nurses , who are educated about delirium , can play a significant role in improving delirium recognition . This study evaluated the impact of a delirium specific educational website . A cluster r and omized controlled trial , with a pretest/post-test time series design , was conducted to measure delirium knowledge ( DK ) and delirium recognition ( DR ) over three time-points . Statistically significant differences were found between the intervention and non-intervention group . The intervention groups ' DK scores were higher and the change over time results were statistically significant [ T3 and T1 ( t=3.78 p=<0.001 ) and T2 and T1 baseline ( t=5.83 p=<0.0
Output:
| Overall , the majority of studies reported improved outcomes post-intervention .
There was evidence of impact on patient and healthcare outcomes as well as learners ’ behaviour and knowledge .
The current evidence base supports the use of education as an effective non-pharmacological approach to prevent and treat delirium .
Healthcare professional education has benefits for inpatient delirium care , as shown by the high number of good- quality studies and the majority demonstrating improved outcomes post-intervention . |
MS212293 | ***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 study was conducted to investigate whether the most common injuries in soccer could be prevented , and to determine if a simple question naire could identify players at increased risk . Hypothesis Introduction of targeted exercise programs to male soccer players with a history of previous injury or reduced function in the ankle , knee , hamstring , or groin will prevent injuries . Study Design R and omized controlled trial ; Level of evidence , 2 . Methods A total of 508 players representing 31 teams were included in the study . A question naire indicating previous injury and /or reduced function as inclusion criteria was used to divide the players into high-risk ( HR ) ( 76 % ) and low-risk ( LR ) groups . The HR players were r and omized individually into an HR intervention group or HR control group . Results A total of 505 injuries were reported , sustained by 56 % of the players . The total injury incidence was a mean of 3.2 ( 95 % confidence interval [ CI ] , 2.5–3.9 ) in the LR control group , 5.3 ( 95 % Cl , 4.6–6.0 ) in the HR control group ( P = .0001 vs the LR control group ) , and 4.9 ( 95 % Cl , 4.3–5.6 ) in the HR intervention group ( P = .50 vs the HR control group ) . For the main outcome measure , the sum of injuries to the ankle , knee , hamstring , and groin , there was also a significantly lower injury risk in the LR control group compared with the 2 other groups , but no difference between the HR intervention group and the HR control group . Compliance with the training programs in the HR intervention group was poor , with only 27.5 % in the ankle group , 29.2 % in the knee group , 21.1 % in the hamstring group , and 19.4 % in the groin defined as having carried out the minimum recommended training volume . Conclusion The players with a significantly increased risk of injury were able to be identified through the use of a question naire , but player compliance with the training programs prescribed was low and any effect of the intervention on injury risk could not be detected 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 A soccer-specific balance training has been shown to decrease injury incidence of the anterior cruciate ligament and ankle sprains in r and omized controlled trials . However , hamstring injuries and tendinopathy remain significant issues in soccer . Hypothesis Proprioceptive training can reduce the incidence of hamstring muscle injuries and tendinopathy in elite soccer . There is a dose-effect relationship between balance training duration and injury incidence . Study Design Cohort study ; Level of evidence , 3 . Methods Twenty-four elite female soccer players ( body mass index , 21.7 ± 1.2 ; age , 21 ± 4 years ) of a German premier league soccer team were prospect ively included . Starting in January 2004 , an additional soccer-specific proprioceptive multistation training was initiated over 3 years . Injury data /1000 hours of exposure with documentation of all occurred injuries , detailed training , and match exposure data as well as time loss data were 100 % complete . Results At the end of the 3-year proprioceptive balance training intervention , noncontact hamstring injury rates were reduced from 22.4 to 8.2/1000 hours ( P = .021 ) , patellar tendinopathy from 3.0 to 1.0/1000 hours ( P = .022 ) , and Achilles tendinopathy from 1.5 to 0.0/1000 hours ( P = .035 ) . There was no effect of balance training on contact injuries . Mean time loss of all assessed injuries significantly decreased from 14.4 days during the control period to 1.5 days during intervention periods ( P = .003 ) . The more minutes of balance training performed , the lower the rate of overall injuries ( r = −0.185 , P = .001 ) , hamstring injuries ( r = −0.267 , P = .003 ) , patellar tendinopathy ( r = −0.398 , P = .02 ) , and gastrocnemius strains ( r = −0.342 , P = .002 ) . Conclusion Soccer-specific balance training ( protective balancing ) can reduce noncontact hamstring injuries and patellar and Achilles tendinopathy . A dose-effect relationship between duration of balance training and injury incidence is evident . A proprioceptive training program reduced the rehabilitation time in noncontact injuries , which warrants further investigation Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Background : Muscle injuries constitute a large percentage of all injuries in football . Purpose : To investigate the incidence and nature of muscle injuries in male professional footballers . Study Design : Cohort study ; Level of evidence , 2 . Methods : Fifty-one football teams , comprising 2299 players , were followed prospect ively during the years 2001 to 2009 . Team medical staff recorded individual player exposure and time-loss injuries . The first-team squads of 24 clubs selected by the Union of European Football Associations as belonging to the best European teams , 15 teams of the Swedish First League , and another 15 European teams playing their home matches on artificial turf pitches were included . A muscle injury was defined as “ a traumatic distraction or overuse injury to the muscle leading to a player being unable to fully participate in training or match play . ” Results : In total , 2908 muscle injuries were registered . On average , a player sustained 0.6 muscle injuries per season . A squad of 25 players can thus expect about 15 muscle injuries per season . Muscle injuries constituted 31 % of all injuries and caused 27 % of the total injury absence . Ninety-two percent of all muscle injuries affected the 4 major muscle groups of the lower limbs : hamstrings ( 37 % ) , adductors ( 23 % ) , quadriceps ( 19 % ) , and calf muscles ( 13 % ) . Sixteen percent of the muscle injuries were reinjuries . These reinjuries caused significantly longer absences than did index injuries . The incidence of muscle injury increased with age . When separated into different muscle groups , however , an increased incidence with age was found only for calf muscle injuries and not for hamstring , quadriceps , or hip/groin strains . Conclusion : Muscle injuries are a substantial problem for players and their clubs . They constitute almost one third of all time-loss injuries in men ’s professional football , and 92 % of all injuries affect the 4 big muscle groups in the lower limbs ‘ More research is needed ’ is a most unhelpful conclusion for the clinician reader of a systematic review . Clinicians look to research ers for the ‘ research evidence ’ part of Professor Sackett ’s ‘ three circles ’ of evidence -based practice .1 The clinician can not ignore the patient in front of him or her just because there is no evidence from systematic review s or r and omised controlled trials ( RCTs ): ‘ Kindly forget about your shoulder problem , until we have better research to tell me what to do ’ ? This will not do ! In this editorial , we share three practical tips for authors synthesis ing lower level evidence in systematic review s , when high- quality RCTs are absent . Our goal is to help authors help clinicians help patients . Consider the patient who plays tennis and presents with shoulder pain . Right now , the clinician who is seeking RCT evidence on how to progress from impairment-focused tasks in neutral shoulder positions to high-level , sport-specific tasks will be disappointed . Being able to function in shoulder elevation positions above The purpose was to test the effect of eccentric strength training and flexibility training on the incidence of hamstring strains in soccer . Hamstring strains and player exposure were registered prospect ively during four consecutive soccer seasons ( 1999 - 2002 ) for 17 - 30 elite soccer teams from Icel and and Norway . The first two seasons were used as baseline , while intervention programs consisting of warm-up stretching , flexibility and /or eccentric strength training were introduced during the 2001 and 2002 seasons . During the intervention seasons , 48 % of the teams selected to use the intervention programs . There was no difference in the incidence of hamstring strains between teams that used the flexibility training program and those who did not [ relative risk (RR)=1.53 , P=0.22 ] , nor was there a difference compared with the baseline data ( RR=0.89 , P=0.75 ) . The incidence of hamstring strains was lower in teams who used the eccentric training program compared with teams that did not use the program ( RR=0.43 , P=0.01 ) , as well as compared with baseline data for the same intervention teams ( RR=0.42 , P=0.009 ) . Eccentric strength training with Nordic hamstring lowers combined with warm-up stretching appears to reduce the risk of hamstring strains , while no effect was detected from flexibility training alone . These results should be verified in r and omized clinical trials PURPOSE To analyze the effect of an eccentric-overload training program ( ie , half-squat and leg-curl exercises using flywheel ergometers ) with individualized load on muscle-injury incidence and severity and performance in junior elite soccer players . METHODS Thirty-six young players ( U-17 to U-19 ) were recruited and assigned to an experimental ( EXP ) or control group ( CON ) . The training program consisted of 1 or 2 sessions/wk ( 3 - 6 sets with 6 repetitions ) during 10 wk . The outcome measured included muscle injury ( incidence per 1000 h of exposure and injury severity ) and performance tests ( countermovement jump [ CMJ ] , 10-m and 20-m sprint test ) . RESULTS Between-groups results showed a likely ( ES : 0.94 ) lower number of days of absence per injury and a possible decrement of incidence per 1000 h of match play in EXP than in CON . Regarding muscle performance , a substantial better improvement ( likely to very likely ) was found in 20-m sprint time ( ES : 0.37 ) , 10-m flying-sprint time ( ES : 0.77 ) , and CMJ ( ES : 0.79 ) for EXP than for CON . Within-group analysis showed an unclear effect in each variable in CON . Conversely , substantial improvements were obtained in CMJ ( ES : 0.58 ) , 20-m sprint time ( ES : 0.32 ) , 10-m flying-sprint time ( ES : 0.95 ) , and injury severity ( ES : 0.59 ) in EXP . Furthermore , a possible decrement in total injury incidence was also reported in EXP . CONCLUSIONS The eccentric-based program led to a reduction in muscle-injury incidence and severity and showed improvements in common soccer tasks such as jumping ability and linear-sprinting speed R and omised controlled trials are the best way to compare the effectiveness of different interventions . Only r and omised trials allow valid inferences of cause and effect . Only r and omised trials have the potential directly to affect patient care — occasionally as single trials but more often as the body of evidence from several trials , whether or not combined formally by meta- analysis . It is thus entirely reasonable to require higher st and ards for papers reporting r and omised trials than those describing other types of study . Like all studies , r and omised trials are open to bias if done badly.1 It is thus essential that r and omised trials are done well and reported adequately . Readers should not have to infer what was probably done , they should be told explicitly . Proper methodology should be used and be seen to have been used . Yet review s of published trials have consistently found major deficiencies in reporting,2 3 4 making the task Research and discussion s about injury rates and their prevention in elite football is one of the hottest topics in the medical and sport science literature . Over the past years , there has been an explosion of the number of publications , including surveys,1 observational , retrospective or prospect ive2 studies , training interventions and various types of expert opinions and commentaries.3 This array of information are likely useful to improve our underst and ing of what the best practice s may be and , in turn , increase our ability to better prepare , manage and treat players . However , a recent survey has shown that 83 % of UEFA clubs do not follow evidence d-based prevention programmes.1 It was also shown that hamstring injuries kept increasing over the last 13 years.2 Taken together , those two papers may suggest that the majority of elite club practitioners likely disregard research findings 1 and may therefore be the one to be blamed for those increased injury rates.2 Making supporting staff and coaches responsible for those injuries is easy , especially when considering their perceived typical personality traits ( ie , so-called type 2,4 high egos and little open-mindedness and willingness to learn—‘why could they be bothered applying the new study findings ? ’ ) . While this may be true sometimes , the reality is that The primary purpose of this study was to evaluate whether a preseason strength training programme for the hamstring muscle group - emphasising eccentric overloading - could affect the occurrence and severity of hamstring injuries during the subsequent competition season in elite male soccer players . Thirty players from two of the best premier-
Output:
| We found limited scientific evidence to support exercise-based strategies to prevent muscle injury in elite footballers . |
MS212294 | ***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: Neonatal Group B streptococcal infections may not respond to antimicrobial therapy and have been associated with case fatality rates of 50 per cent or greater . We evaluated the effect on colonization and disease rates of a single intramuscular dose of aqueous penicillin G given at birth in a prospect ively controlled study of 18,738 neonates during a 25-month period . The colonization rate in the mothers was 26.6 per cent , with 50 per cent concordance in the untreated infants and 12.2 per cent in the penicillin-treated infants ( P < 0.001 ) . There was a significant decrease in the incidence of disease caused by all penicillin-susceptible organisms in the penicillin group ( 0.64 vs. 2.26 cases per thous and live births , P = 0.005 ) . Disease caused by penicillin-resistant pathogens was increased in the penicillin-treated group during the first year of the study but was unaffected during the second year . Routine administration of parenteral penicillin at birth can not be recommended until the effect on the incidence of disease caused by penicillin-resistant pathogens is fully defined This prospect i ve study was design ed to identify the role of postnatal penicillin prophylaxis in the prevention of neonatal group B streptococcus ( GBS ) infection . We studied 10 998 infants . Of these , 5389 were in the penicillin prophylaxis group ( PP ) and 5609 infants did not receive penicillin prophylaxis ( NPP ) . Infants were allocated to treatment by month of birth , alternating 3‐mo blocks or 2‐mo blocks to the two groups after the first block was r and omly assigned . The use of PP reduced the incidence of clinical sepsis ( 1.7 % PP versus 2.5 % NPP , p<0.01 ) , GBS infection ( 0.4 % PP versus 0.9 % NPP , p < 0.001 ) and deaths from sepsis ( 0.1 % PP versus 0.3 % NPP , p < 0.05 ) . We conclude that the routine use of postnatal penicillin prophylaxis appears to be effective in reducing the incidence of clinical sepsis and death from sepsis in neonates . □ Antimicrobial prophylaxis , group B streptococcus , neonatal The efficacy of a single dose of aqueous penicillin G in preventing neonatal group-B streptococcal infections was demonstrated in a r and omised study conducted over 41 months . 16 082 infant received a single dose of penicillin within one hour of delivery , and 15 976 infants who received tetracycline ophthalmic ointment served as the control group . Group-B streptococcal systemic infections were significantly less common in the penicillin-treated infants ( 0.6 vs 1.7 cases per 100 live birth , p = 0.004 ) . The incidence of infection caused by penicillin-resistant pathogen was insignificantly increased in the penicillin group ( 2.2 vs 1.6 cases per thous and live birth , p = 0.32 ) . this difference was accounted for almost completely by the events of the first 12 months of the study period when , for unexplained reasons , there was a considerable increase in the number of penicillin-resistant infections in the penicillin group ( 3.6 vs 1.4 cases per 1000 live births , p = 0.09 ) . The mortality associated with penicillin-susceptible pathogens was higher in the control group ( 0.1 vs 0.4 per 1000 live births , p = 0.18 ) . However , the mortality associated with penicillin-resistant pathogens was increased in the penicillin ( 0.4 vs 1.0 per 1000 live births , p = 0.06 ) . The combined mortality rates for all pathogens were not significantly different ( 1.1 vs 0.7 per 1000 liver births , p = 0.27 , for the penicillin and control groups , respectively ) and were nearly equivalent when the excess number of deaths associated with penicillin-resistant infections in the penicillin group during the first study year was excluded from analysis . The incidence of gonococcal ophthalmia and conjunctivitis was unaffected by the use of intramuscular penicillin at birth OBJECTIVE Recommendations for the use of antenatal antibiotics in obstetrics have increased in the past few years , especially for prophylaxis against group B streptococci , for prolongation of the latency time in patients with preterm premature rupture of the membranes , and as an adjuvant treatment in preterm labor . Our objective was to determine whether the use of antenatal ampicillin affects the incidence of and resistance of early-onset neonatal sepsis with organisms other than group B streptococci . STUDY DESIGN A prospect i ve cohort study was performed between January 1 , 1991 , and December 31 , 1996 . Every case of blood culture-proven neonatal sepsis was prospect ively surveyed . The type of bacteria isolated , drug resistance , antenatal antibiotic use and treatment indication , gestational age at delivery , and other antenatal and outcome variables were gathered . Early-onset neonatal sepsis was defined as disease onset within 7 days after birth . RESULTS A total of 42 cases of early-onset neonatal sepsis among 29,897 neonates delivered were found during the 6-year period . Of these , 15 cases were due to group B streptococci and 27 were the result of non-group B streptococcal organisms ( 21 gram-negative rods and 6 gram-positive cocci ) . Among the 27 non-group B streptococcal cases , 15 mothers had received antenatal ampicillin and 13 of the 15 bacterial isolates from these neonates ( 87 % ) were resistant to ampicillin , versus only 2 ampicillin-resistant isolates ( 17 % ) among the 12 cases in which no antenatal antibiotics were administered ( P = .0004 ) . Of the 15 mothers who were treated with ampicillin , 13 received more than 1 dose . In evaluating each year of the study , the overall administration of antibiotics to pregnant women in the antenatal period increased from < 10 % in 1991 to 16.9 % in 1996 . The incidence of early-onset neonatal sepsis with group B streptococci decreased during this time , whereas the incidence of early-onset sepsis with non-group B streptococcal organisms , especially Escherichia coli , increased . CONCLUSIONS The increased administration of antenatal ampicillin to pregnant women may be responsible for the increased incidence of early-onset neonatal sepsis with non-group B streptococcal organisms that are resistant to ampicillin . At this time penicillin G , rather than ampicillin , is therefore recommended for prophylaxis against group B streptococci . In addition , future studies are needed to determine whether alternate approaches , such as immunotherapy or vaginal washing , could be of benefit Abstract . Colonization with group B streptococci of the genital tract was studied in 1115 women during the last trimester of pregnancy . 76 or 6.82 % were found to harbour this bacterium . The incidence of contamination was significantly higher among Belgian women than among parturients of Mediterranean origin ( p < 0.001 ) . It was also more frequent in primigravidae ( p<0.05 ) and in the poorer ( 0.10 < p > 0.05 ) . At the time of admission in the delivery room , it was noticed that rupture of the amniotic membranes for more than 24 hours was more often associated with group B streptococcal carriage by the mother ( p<0.001 ) . 29 out of 68 ( 42.6 % ) infants born to group B streptococci positive mothers were colonized at birth . 67 of them were su bmi tted to a controlled trial of immediate versus delayed penicillin therapy . 44.8 % and 42.1 % of the neonates were contaminated at birth in each group of treatment respectively . No instance of group B streptococcal infection developed in either group . This suggests that immediate therapy with penicillin of infants of group B streptococci positive mothers has no definite advantage upon delayed treatment This document reflects emerging clinical and scientific advances on the date issued and is subject to change . The information should not be construed as dictating an exclusive course of treatment or procedure to be followed . Local institutions can dictate amendments to these opinions . They should be well documented if modified at the local level . None of these contents may be reproduced in any form without prior written permission of the SOGC . This Clinical Practice Guideline has been prepared by the Infectious Disease Committee , review ed by the Infectious Diseases and Immunization and the Fetus and Newborn Committees of the Canadian Paediatric Society , and the SOGC Family Practice Advisory Committee , and approved by the Executive and Council of the Society of Obstetricians and Gynaecologists of Canada . We studied the effect of penicillin on early-onset Group B streptococcal disease over a 52-month period in neonates who were at high risk of infection . Shortly after birth , 1187 neonates weighing 2000 g or less had blood sample s taken for cultures and were r and omized into an early-treatment group ( given intramuscular penicillin G within 60 minutes of birth ) or a control group . The incidence of early-onset disease was 20 per 1000 live births ( 24 of 1187 ) ; the number of infants in the early-treatment group who had disease ( 10 of 589 ) was similar to that in the control group ( 14 of 598 ) . The fatality rates were similar in both groups ( 6 of 10 vs. 8 of 14 ) . Cultures from blood obtained with one hour of birth were positive in 21 of the 24 infants with disease ; 22 of the 24 were symptomatic within four hours of birth . Thus , infection was well established before the first hour of postnatal life . At autopsy , gram-positive cocci were seen in lung sections of four infants in whom cultures of blood obtained after treatment had been sterile ; this indicates that giving routine antibiotic therapy before culture sample s are obtained can obscure bacteriologic diagnosis . We conclude that penicillin given at birth to neonates weighing 2000 g or less does not prevent early-onset streptococcal disease or reduce excess mortality associated with disease Objective To determine the effect of single-dose penicillin given at birth on the rate of early-onset group B streptococcal ( GBS ) invasive disease in an inner-city population . Methods Laboratory-based surveillance of GBS disease from 1972–1994 at Parkl and Memorial Hospital and Children 's Medical Center in Dallas , Texas , was review ed retrospectively . All infants born at Parkl and Memorial Hospital from January 1 , 1972 to December 31 , 1994 , or a total of 259,049 live births , were included . Early-onset ( within 3 days ) GBS disease rates were compared for each of five observation groups to determine the efficacy of a single dose of aqueous penicillin G ( 50,000 U for infants weighing 2000 g or more and 25,000 U for those weighing less than 2000 g ) administered intramuscularly within 1 hour of delivery for prevention of GBS disease . Results The rates of early-onset GBS disease were compared in five observation groups : A ) pre- study , January 1 , 1972 to December 3 , 1977—no GBS prophylaxis ; B ) prospect i ve , controlled intervention study , December 4 , 1977 to May 31 , 1981 , including infants who received a single dose of penicillin at birth ( group B1 ) and those who did not ( group B2 ) ; C ) universal penicillin prophylaxis , June 1 , 1981 to October 31 , 1986 ; and D ) no routine penicillin prophylaxis , November 1 , 1986 to December 31 , 1994 . The incidence of early-onset GBS disease in the penicillin groups ( B1 , C ) was significantly lower than that in the untreated groups ( A , B2 , D ) : 0.25 and 0.63 per 1000 versus 1.59 , 1.19 , and 1.95 per 1000 , respectively ( P ≤ .03 ) . The incidence of late-onset GBS disease was unaffected by penicillin prophylaxis , and there was no increase in the incidence of disease caused by penicillin-resistant pathogens or associated mortality in penicillin-treated infants : 2.2 and 2.1 per 1000 versus 1.6 and 3.3 per 1000 for disease ; 1.0 and 0.5 per 1000 versus 0.4 and 0.3 per 1000 for deaths . Conclusion Universal administration of single-dose pencillin at birth is a safe and effective intervention for the prevention of early-onset GBS
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| REVIEW ERS ' CONCLUSIONS This review does not support the routine use of intramuscular penicillin to prevent EOGBSD in newborn infants . |
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Input: Background Previous qualitative studies have found that exercise may facilitate symptomatic and functional recovery in people with long-term schizophrenia . This study examined the perceived effects of exercise as experienced by people in the early stages of psychosis , and explored which aspects of an exercise intervention facilitated or hindered their engagement . Methods Nineteen semi-structured interviews were conducted with early intervention service users who had participated in a 10-week exercise intervention . Interviews discussed people ’s incentives and barriers to exercise , short- and long-term effects , and opinions on optimal interventions . A thematic analysis was applied to determine the prevailing themes . Results The intervention was perceived as beneficial and engaging for participants . The main themes were ( a ) exercise alleviating psychiatric symptoms , ( b ) improved self-perceptions following exercise , and ( c ) factors determining exercise participation , with three respective sub-themes for each . Conclusions Participants explained how exercise had improved their mental health , improved their confidence and given them a sense of achievement . Autonomy and social support were identified as critical factors for effectively engaging people with first-episode psychosis in moderate-to-vigorous exercise . Implementing such programs in early intervention services may lead to better physical health , symptom management and social functioning among service users . Trial registration Current Controlled Trials IS RCT N09150095 . Registered 10 December 2013 Objective : To examine a 1-year follow-up of a 4-month , controlled clinical trial of exercise and antidepressant medication in patients with major depressive disorder ( MDD ) . Methods : In the original study , 202 sedentary adults with MDD were r and omized to : a ) supervised exercise ; b ) home-based exercise ; c ) sertraline ; or d ) placebo pill . We examined two outcomes measured at 1-year follow-up ( i.e. , 16 months post r and omization ) : 1 ) continuous Hamilton Depression Rating Scale score ; and 2 ) MDD status ( depressed ; partial remission ; full remission ) in 172 available participants ( 85 % of the original cohort ) . Regression analyses were performed to examine the effects of treatment group assignment , as well as follow-up antidepressant medication use and self-reported exercise ( Godin Leisure-Time Exercise Question naire ) , on the two outcomes . Results : In the original study , patients receiving exercise achieved similar benefits compared with those receiving sertraline . At the time of the 1-year follow-up , rates of MDD remission increased from 46 % at post treatment to 66 % for participants available for follow-up . Neither initial treatment group assignment nor antidepressant medication use during the follow-up period were significant predictors of MDD remission at 1 year . However , regular exercise during the follow-up period predicted both Hamilton Depression Rating Scale scores and MDD diagnosis at 1 year . This relationship was curvilinear , with the association concentrated between 0 minute and 180 minutes of weekly exercise . Conclusion : The effects of aerobic exercise on MDD remission seem to be similar to sertraline after 4 months of treatment ; exercise during the follow-up period seems to extend the short-term benefits of exercise and may augment the benefits of antidepressant use . Trial Registration : clinical trials.gov Identifier : NCT00331305 . MDD = major depressive disorder ; HAM-D = Hamilton Depression Rating Scale ; SCID = Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition Axis I Disorders ; PSSS = Perceived Social Support Scale OBJECTIVE The aim of this study was to examine both single and joint associations of physical activity and conventional cardiovascular risk factors with total and cardiovascular mortality among patients with diabetes . RESEARCH DESIGN AND METHODS We prospect ively followed 3,708 Finnish patients with type 2 diabetes aged 25 - 74 years . Physical activity , smoking status , blood pressure , height , weight , and serum cholesterol level were determined at baseline . Cox proportional hazard models were used to estimate single and joint effects of physical activity and other cardiovascular risk factors on the risk of mortality . RESULTS During a mean follow-up of 18.7 years , 1,423 deaths were recorded , 906 of which were due to cardiovascular disease . Moderate or high levels of physical activity were associated with decreased total and cardiovascular mortality , whereas higher levels of BMI and blood pressure and current smoking were associated with increased total and cardiovascular mortality . High serum cholesterol levels also increased cardiovascular mortality . The protective effect of physical activity was consistent in diabetic patients with any levels of BMI , blood pressure , total cholesterol , and smoking . CONCLUSIONS A moderate or high level of physical activity was associated with a reduced risk of total and cardiovascular mortality among patients with type 2 diabetes . The favorable association of physical activity with longevity was observed regardless of the levels of BMI , blood pressure , total cholesterol , and smoking The objective of this multicenter r and omised clinical trial was to examine the effect of exercise versus occupational therapy on mental and physical health in schizophrenia patients Background : Increasingly alarmed by the health risks ( that is , weight gain , elevated lipids , and poor glucose tolerance ) posed by novel antipsychotic medications , clinicians who treat schizophrenia are attempting to help patients improve lifestyle factors . Unfortunately , schizophrenia research has neglected exercise as a legitimate adjunctive treatment for schizophrenia . Objective : To assess the extent to which stable patients with schizophrenia would adhere to an exercise program if offered access to a fitness facility . Methods : Ten of 20 stable patients with schizophrenia or schizoaffective disorder who were treated with olanzapine for at least 4 weeks had the opportunity to receive access to a Young Men 's Christian Association ( YMCA ) fitness facility , based on r and om allocation . The intervention included a free membership to the YMCA for 6 months , with access to all the fitness amenities and equipment . The mean dosage of olanzapine was 11.5 mg daily for the YMCA group . Results : Of the 10 subjects , 2 did not attend at all . One subject met criteria for full attendance for each of the 6 months and lost 15 kg . Dropout rates were as follows : 90 % at 6 months , 70 % at 5 months , and 40 % at 4 months . The main reason they gave for poor attendance was lack of motivation . The mean weight gain was 2 kg in the YMCA group . Conclusion : Most subjects did not regularly exercise or attend . They cited poor motivation as the main reason . The subject who exercised regularly lost a significant amount of weight AIM Initiating antipsychotic medication frequently induces rapid , clinical ly significant weight gain . We aim ed to evaluate the effectiveness of a lifestyle and life skills intervention , delivered within 4 weeks of antipsychotic medication initiation , in attenuating weight gain in youth aged 14 - 25 years with first-episode psychosis ( FEP ) . METHODS We undertook a prospect i ve , controlled study in two early psychosis community services . Intervention participants ( n = 16 ) received a 12-week individualized intervention delivered by specialist clinical staff ( nurse , dietician and exercise physiologist ) and youth peer wellness coaches , in addition to st and ard care . A comparison group was recruited from a similar service and received st and ard care ( n = 12 ) . RESULTS The intervention group experienced significantly less weight gain at 12 weeks compared to st and ard care ( 1.8 kg , 95 % CI -0.4 to 2.8 vs. 7.8 kg , 4.8 - 10.7 , P < 0.001 ) . Thirteen per cent ( 2/16 ) of the intervention group experienced clinical ly significant weight gain ( greater than 7 % of baseline weight ) , while 75 % ( 9/12 ) of the st and ard care group experienced this level of weight gain . Similar positive effects of the intervention were observed for waist circumference . CONCLUSIONS A lifestyle and life skills intervention delivered as part of st and ard care attenuated antipsychotic-induced weight gain in young people with FEP . The intervention was acceptable to the young people referred to the service . Such interventions may prevent the seeding of future disease risk and in the long-term help reduce the life expectancy gap for people living with serious mental illness The purpose of this prospect i ve and observational design study was to assess the feasibility of using a pedometer and step log to explore level of physical activity ( PA ) and to assess motivation to be physically active in adults with schizophrenia . Descriptive statistics were used to analyse data of 7 male and 5 female subjects . Pedometer data indicated that subjects walked an average of 4731.03 ( ±3318.19 ) steps and 5002.58 ( ±3041.03 ) during the first week and second week of the study , respectively . A minimum 30-min walk was recorded on an average of 3.67 ( ±1.82 ) days ( week one ) and 4.5 ( ±1.88 ) days ( week two ) . Step logs , inconsistently maintained by subjects , were not able to be analysed . Examination of the Motives for Physical Activity Measure-Revised ( MPAM-R ) at baseline indicates that exercise fitness and body appearance were subjects ' primary motives for PA participation . Study findings indicate that it is feasible to use a pedometer to monitor the level of PA . However , maintenance of a concurrent step log requires further consideration to determine realistic outcomes . Extrinsically focused motivations for PA in this study sample may predict low PA adherence Individuals with schizophrenia display substantial neurocognitive deficits for which available treatments offer only limited benefits . Yet , findings from studies of animals , clinical and non clinical population s have linked neurocognitive improvements to increases in aerobic fitness ( AF ) via aerobic exercise training ( AE ) . Such improvements have been attributed to up-regulation of brain-derived neurotrophic factor ( BDNF ) . However , the impact of AE on neurocognition , and the putative role of BDNF , have not been investigated in schizophrenia . Employing a proof-of-concept , single-blind , r and omized clinical trial design , 33 individuals with schizophrenia were r and omized to receive st and ard psychiatric treatment ( n = 17 ; " treatment as usual " ; TAU ) or attend a 12-week AE program ( n = 16 ) utilizing active-play video games ( Xbox 360 Kinect ) and traditional AE equipment . Participants completed assessment s of AF ( indexed by VO2 peak ml/kg/min ) , neurocognition ( MATRICS Consensus Cognitive Battery ) , and serum-BDNF before and after and 12-week period . Twenty-six participants ( 79 % ) completed the study . At follow-up , the AE participants improved their AF by 18.0 % vs a -0.5 % decline in the TAU group ( P = .002 ) and improved their neurocognition by 15.1 % vs -2.0 % decline in the TAU group ( P = .031 ) . Hierarchical multiple regression analyses indicated that enhancement in AF and increases in BDNF predicted 25.4 % and 14.6 % of the neurocognitive improvement variance , respectively . The results indicate AE is effective in enhancing neurocognitive functioning in people with schizophrenia and provide preliminary support for the impact of AE-related BDNF up-regulation on neurocognition in this population . Poor AF represents a modifiable risk factor for neurocognitive dysfunction in schizophrenia for which AE training offer a safe , nonstigmatizing , and side-effect-free intervention OBJECTIVE The objective of this study was to evaluate the effectiveness of a fitness health mentor program ( In SHAPE ) in improving physical fitness and weight loss among overweight and obese adults with serious mental illness . METHODS A r and omized controlled trial was conducted with 133 persons with serious mental illness and a body mass index ( BMI ) > 25 who were assigned either to the In SHAPE program ( one year of weekly sessions with a fitness trainer plus a fitness club membership ) or to one year of fitness club membership and education . Assessment s were conducted at baseline and three , six , nine , and 12 months later . RESULTS Participants had a mean baseline weight of 231.8±54.8 pounds and a mean BMI of 37.6±8.2 . At 12-month follow-up , In SHAPE ( N=67 ) compared with fitness club membership and education ( N=66 ) was associated with three times greater fitness club attendance , twice as much participation in physical exercise , greater engagement in vigorous physical activity , and improvement in diet . Twice the proportion of participants ( 40 % versus 20 % ) achieved clinical ly significant improvement in cardiorespiratory fitness ( > 50 m on the six-minute walk test ) . Weight loss and BMI did not differ between groups . Among In SHAPE participants , 49 % achieved either clinical ly significant increased fitness or weight loss ( 5 % or greater ) , and 24 % achieved both clinical ly significant improved fitness and weight loss . CONCLUSIONS The In SHAPE program achieved clinical ly significant reduction in cardiovascular risk for almost one-half of participants at 12 months . Although the intervention showed promise in improving fitness , optimizing weight loss may require additional intensive , multicomponent dietary interventions
Output:
| Many of the desirable outcomes of exercise for people with SMI , such as mood improvement , stress reduction and increased energy , are inversely related to the barriers of depression , stress and fatigue which frequently restrict their participation in exercise .
Providing patients with professional support to identify and achieve their exercise goals may enable them to overcome psychological barriers , and maintain motivation towards regular physical activity |
MS212296 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background — Dabigatran and warfarin have been compared for the treatment of acute venous thromboembolism ( VTE ) in a previous trial . We undertook this study to extend those findings . Methods and Results — In a r and omized , double-blind , double-dummy trial of 2589 patients with acute VTE treated with low-molecular-weight or unfractionated heparin for 5 to 11 days , we compared dabigatran 150 mg twice daily with warfarin . The primary outcome , recurrent symptomatic , objective ly confirmed VTE and related deaths during 6 months of treatment occurred in 30 of the 1279 dabigatran patients ( 2.3 % ) compared with 28 of the 1289 warfarin patients ( 2.2 % ; hazard ratio , 1.08 ; 95 % confidence interval [ CI ] , 0.64–1.80 ; absolute risk difference , 0.2 % ; 95 % CI , −1.0 to 1.3 ; P<0.001 for the prespecified noninferiority margin for both criteria ) . The safety end point , major bleeding , occurred in 15 patients receiving dabigatran ( 1.2 % ) and in 22 receiving warfarin ( 1.7 % ; hazard ratio , 0.69 ; 95 % CI , 0.36–1.32 ) . Any bleeding occurred in 200 dabigatran ( 15.6 % ) and 285 warfarin ( 22.1 % ; hazard ratio , 0.67 ; 95 % CI , 0.56–0.81 ) patients . Deaths , adverse events , and acute coronary syndromes were similar in both groups . Pooled analysis of this study RE-COVER II and the RE-COVER trial gave hazard ratios for recurrent VTE of 1.09 ( 95 % CI , 0.76–1.57 ) , for major bleeding of 0.73 ( 95 % CI , 0.48–1.11 ) , and for any bleeding of 0.70 ( 95 % CI , 0.61–0.79 ) . Conclusion — Dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE . Clinical Trial Registration — URL : www . clinical trials.gov . Unique identifiers : NCT00680186 and NCT00291330 Background — Rivaroxaban and dabigatran are new oral anticoagulants that specifically inhibit factor Xa and thrombin , respectively . Clinical studies on the prevention and treatment of venous and arterial thromboembolism show promising results . A major disadvantage of these anticoagulants is the absence of an antidote in case of serious bleeding or when an emergency intervention needs immediate correction of coagulation . This study evaluated the potential of prothrombin complex concentrate ( PCC ) to reverse the anticoagulant effect of these drugs . Methods and Results — In a r and omized , double-blind , placebo-controlled study , 12 healthy male volunteers received rivaroxaban 20 mg twice daily ( n=6 ) or dabigatran 150 mg twice daily ( n=6 ) for 2½ days , followed by either a single bolus of 50 IU/kg PCC ( Cofact ) or a similar volume of saline . After a washout period , this procedure was repeated with the other anticoagulant treatment . Rivaroxaban induced a significant prolongation of the prothrombin time ( 15.8±1.3 versus 12.3±0.7 seconds at baseline ; P<0.001 ) that was immediately and completely reversed by PCC ( 12.8±1.0 ; P<0.001 ) . The endogenous thrombin potential was inhibited by rivaroxaban ( 51±22 % ; baseline , 92±22 % ; P=0.002 ) and normalized with PCC ( 114±26 % ; P<0.001 ) , whereas saline had no effect . Dabigatran increased the activated partial thromboplastin time , ecarin clotting time ( ECT ) , and thrombin time . Administration of PCC did not restore these coagulation tests . Conclusion — Prothrombin complex concentrate immediately and completely reverses the anticoagulant effect of rivaroxaban in healthy subjects but has no influence on the anticoagulant action of dabigatran at the PCC dose used in this study . Clinical Trial Registration — URL : http://www.trialregister.nl . Unique identifier : NTR2272 BACKGROUND Apixaban , an oral potent reversible direct inhibitor of activated factor X , has shown promise in the prevention of venous thromboembolism following major orthopedic surgery . We conducted a dose-ranging study in patients with deep vein thrombosis . METHODS Consecutive patients with symptomatic deep vein thrombosis were included and r and omized to receive 84 - 91 days of apixaban 5 mg twice-daily , 10 mg twice-daily , or 20 mg once-daily , or low molecular weight heparin ( LMWH ) followed by a vitamin K antagonist ( VKA ) . The primary efficacy outcome was the composite of symptomatic recurrent venous thromboembolism and asymptomatic deterioration of bilateral compression ultrasound or perfusion lung scan . The principal safety outcome was the composite of major and clinical ly relevant , non-major bleeding . RESULTS The mean age of the 520 included patients was 59 years , and 62 % were male . The primary outcome occurred in 17 of the 358 apixaban-treated patients [ 4.7 % , 95 % confidence interval ( CI ) 2.8 - 7.5 % ] and in five of the 118 LMWH/VKA-treated patients ( 4.2 % , 95 % CI 1.4 - 9.6 % ) who were evaluable . The incidence in all three apixaban groups was low and comparable without evidence of a dose response . The principal safety outcome occurred in 28 ( 7.3 % ) of the 385 apixaban-treated patients and in 10 ( 7.9 % ) of the 126 LMWH/VKA-treated patients . No dose response for apixaban was observed . CONCLUSION These observations warrant further evaluation of apixaban in phase III studies . The attractive fixed-dose regimen of this compound may meet the dem and to simplify anticoagulant treatment in patients with established venous thromboembolism BACKGROUND Apixaban , an oral factor Xa inhibitor administered in fixed doses , may simplify the treatment of venous thromboembolism . METHODS In this r and omized , double-blind study , we compared apixaban ( at a dose of 10 mg twice daily for 7 days , followed by 5 mg twice daily for 6 months ) with conventional therapy ( subcutaneous enoxaparin , followed by warfarin ) in 5395 patients with acute venous thromboembolism . The primary efficacy outcome was recurrent symptomatic venous thromboembolism or death related to venous thromboembolism . The principal safety outcomes were major bleeding alone and major bleeding plus clinical ly relevant nonmajor bleeding . RESULTS The primary efficacy outcome occurred in 59 of 2609 patients ( 2.3 % ) in the apixaban group , as compared with 71 of 2635 ( 2.7 % ) in the conventional-therapy group ( relative risk , 0.84 ; 95 % confidence interval [ CI ] , 0.60 to 1.18 ; difference in risk [ apixaban minus conventional therapy ] , -0.4 percentage points ; 95 % CI , -1.3 to 0.4 ) . Apixaban was noninferior to conventional therapy ( P<0.001 ) for predefined upper limits of the 95 % confidence intervals for both relative risk ( < 1.80 ) and difference in risk ( < 3.5 percentage points ) . Major bleeding occurred in 0.6 % of patients who received apixaban and in 1.8 % of those who received conventional therapy ( relative risk , 0.31 ; 95 % CI , 0.17 to 0.55 ; P<0.001 for superiority ) . The composite outcome of major bleeding and clinical ly relevant nonmajor bleeding occurred in 4.3 % of the patients in the apixaban group , as compared with 9.7 % of those in the conventional-therapy group ( relative risk , 0.44 ; 95 % CI , 0.36 to 0.55 ; P<0.001 ) . Rates of other adverse events were similar in the two groups . CONCLUSIONS A fixed-dose regimen of apixaban alone was noninferior to conventional therapy for the treatment of acute venous thromboembolism and was associated with significantly less bleeding ( Funded by Pfizer and Bristol-Myers Squibb ; Clinical Trials.gov number , NCT00643201 ) Background and Purpose — Intracranial hemorrhage is the most devastating complication of anticoagulation . Outcomes associated with different sites of intracranial bleeding occurring with warfarin versus dabigatran have not been defined . Methods — Analysis of 18 113 participants with atrial fibrillation in the R and omized Evaluation of Long-term anticoagulant therapY ( RE-LY ) trial assigned to adjusted-dose warfarin ( target international normalized ratio , 2–3 ) or dabigatran ( 150 mg or 110 mg , both twice daily ) . Results — During a mean of 2.0 years of follow-up , 154 intracranial hemorrhages occurred in 153 participants : 46 % intracerebral ( 49 % mortality ) , 45 % subdural ( 24 % mortality ) , and 8 % subarachnoid ( 31 % mortality ) . The rates of intracranial hemorrhage were 0.76 % , 0.31 % , and 0.23 % per year among those assigned to warfarin , dabigatran 150 mg , and dabigatran 110 mg , respectively ( P<0.001 for either dabigatran dose versus warfarin ) . Fewer fatal intracranial hemorrhages occurred among those assigned dabigatran 150 mg and 110 mg ( n=13 and n=11 , respectively ) versus warfarin ( n=32 ; P<0.01 for both ) . Fewer traumatic intracranial hemorrhages occurred among those assigned to dabigatran ( 11 patients with each dose ) compared with warfarin ( 24 patients ; P<0.05 for both dabigatran doses versus warfarin ) . Independent predictors of intracranial hemorrhage were assignment to warfarin ( relative risk , 2.9 ; P<0.001 ) , aspirin use ( relative risk , 1.6 ; P=0.01 ) , age ( relative risk , 1.1 per year ; P<0.001 ) , and previous stroke/transient ischemic attack ( relative risk , 1.8 ; P=0.001 ) . Conclusions — The clinical spectrum of intracranial hemorrhage was similar for patients given warfarin and dabigatran . Absolute rates at all sites and both fatal and traumatic intracranial hemorrhages were lower with dabigatran than with warfarin . Concomitant aspirin use was the most important modifiable independent risk factor for intracranial hemorrhage The primary objective of this study was to compare the safety of four fixed-dose regimens of edoxaban with warfarin in patients with non-valvular atrial fibrillation ( AF ) . In this 12-week , parallel-group , multicentre , multinational study , 1,146 patients with AF and risk of stroke were r and omised to edoxaban 30 mg qd , 30 mg bid , 60 mg qd , or 60 mg bid or warfarin dose-adjusted to a target international normalised ratio of 2.0 - 3.0 . The study was double-blind to edoxaban dose , but open-label to warfarin . Primary outcomes were occurrence of major and /or clinical ly relevant non-major bleeding and elevated hepatic enzymes and /or bilirubin . Mean age was 65 + /- 8.7 years and 64.4 % were warfarin-naïve . Whereas major plus clinical ly relevant non-major bleeding occurred in 3.2 % of patients r and omised to warfarin , the incidence of bleeding was significantly higher with the edoxaban 60 mg bid ( 10.6 % ; p=0.002 ) and 30 mg bid regimens ( 7.8 % ; p=0.029 ) , but not with the edoxaban 60 mg qd ( 3.8 % ) or 30 mg qd regimens ( 3.0 % ) . For the same total daily dose of 60 mg , both bleeding frequency and trough edoxaban concentrations were higher in the 30-mg bid group than in the 60-mg qd group . There were no significant differences in hepatic enzyme elevations or bilirubin values among the groups . The safety profiles of edoxaban 30 and 60 mg qd in patients with AF were similar to warfarin . In contrast , the edoxaban bid regimens were associated with more bleeding than warfarin . These results
Output:
| The reduced odds of fatal bleeding with NOACs was not demonstrated after controlling for bleeding location .
AUTHOR ’S CONCLUSIONS : The odds ratio calculated in this meta- analysis showed a reduced odds of death in major bleeding associated with NOAC use .
This risk reduction was due to a disproportionate amount of intracranial bleeding in the VKA arms .
For any given bleeding site , there was no evidence of a significant difference in fatal outcomes from bleeds associated with NOAC versus VKA use . |
MS212297 | ***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 implement and evaluate pharmaceutical care services for patients with hyperlipidemias in the community pharmacy setting , to evaluate the results of a pharmaceutical care training process for pharmacists by using an assessment quiz , and to measure patient outcomes result ing from provision of pharmaceutical care to patients with hyperlipidemia . DESIGN : A prospect i ve study was conducted over a 1 -year period . Patients served as their own controls . SETTING : Two independent community pharmacies in Richmond , Virginia . PARTICIPANTS : Twenty-five adult patients with confirmed dyslipidemias completed the study . INTERVENTIONS : Study pharmacists assessed each patient and assisted in setting therapeutic goals ; patients also completed a visit with a registered dietitian . Drug therapy recommendations were made to physicians by the pharmacist when appropriate . Follow-up was scheduled with the pharmacist to ensure positive outcomes and reduce adverse effects . MAIN OUTCOME MEASURES : Fasting lipoprotein profiles were measured initially and at 6 and 12 months . The SF-36 survey , the MacKeigan-Larson satisfaction survey , and a patient opinion survey were administered initially and at the conclusion of the study . RESULTS : Total cholesterol and low-density lipoprotein cholesterol values were significantly decreased at 12 months compared with either the baseline or 6-month values ( p < 0.02 ) . Significant improvement was found in several domains of the surveys ; quality of life , patient satisfaction with pharmacy services , and patient opinions on the role of the pharmacist improved after the intervention . CONCLUSIONS : Pharmaceutical care may positively affect lipid values , quality of life , and patient satisfaction The impacts of two models of pharmacist consultation on patient function and health-related quality of life ( HRQOL ) relative to a control model were studied . Patients in the r and om-assignment study and the areawide study of the Kaiser Permanente/USC Patient Consultation Study were surveyed three times over a two-year period . The patients were receiving pharmaceutical services under the Kaiser Permanente model of consultation ( KP model ) , a state model of consultation , or a control model and were stratified according to prescription drug use . A global visual-analogue scale and Short Form-36 were used to assess HRQOL . In the areawide study , only 2 of 42 comparisons of the effects of the KP or state model on HRQOL were significant ; both were associated with the state model and involved only small increases . In the r and om-assignment study , 3 of 21 estimated effects of the KP model on HRQOL were positive and significant ; 2 of these were significantly different between the KP model and the state model . Although the KP and state models of consultation were associated with some changes in HRQOL , the overall influence was not consistent and not clinical ly important The impacts of three alternative models of pharmacist consultation on the use and cost of health care services were studied . Two studies were conducted concurrently in an HMO over two years . In one , 6000 patients were r and omly assigned to one of three consultation models ; in the other , the three models were implemented in six geographic regions of California ( 4600 patients ) . The models were ( 1 ) consultation about new or changed prescriptions as m and ated by state law ( state model ) , ( 2 ) consultation focused on selected high-risk ambulatory care patients ( Kaiser Permanente [ KP ] model ) , and ( 3 ) a control model . The patients were surveyed three times about their health status and satisfaction , and computerized data on health care use and cost were collected . The effect of the consultation models on the use and cost of health care services was examined across five risk groups that were based on drug-use profiles . An additional 37,750 patients ( 10 % of the patients residing in the areawide study sites ) were included in a supplemental analysis of the use and cost of health care services . There was no indication in the r and om-assignment study that pharmacist consultations affected either drug costs or the cost of office visits . Similar results were found in the areawide study , with the exception that the KP model was associated with lower drug costs than the control model . In the 10 % sample , the KP model appeared to be associated with lower office visit costs but higher drug costs . Both models were associated with a lower likelihood of a hospital admission and with lower total health care costs for some high-risk patients compared with the control model . Counseling patients about their medications may be unlikely to reduce medication costs or the cost of office visits but may reduce the likelihood of hospital admissions and the overall costs of health care services ; a combination of counseling patients at high risk for drug-related problems and counseling all patients about any new or changed prescription should be considered This study evaluated pharmaceutical care as an adjunct to an existing , coordinated-care program at a Regional Diabetes Center . The progress of a control group receiving the st and ard pharmacist instruction was compared with two treatment groups receiving additional small group or individual supplementary education for a 2-month period . Outcome evaluation included assessment of individual diabetes management through blood glucose monitoring and responses on a pretest and posttest question naire . Patients in the treatment groups demonstrated significantly lower average weekly blood glucose levels and a decreased incidence of hyperglycemic episodes compared with the control group . Question naire data for both treatment groups demonstrated a significant increase in patient underst and ing of diabetes medications and medications for associated illnesses , an increase in knowledge about blood glucose monitoring , and a positive difference in perceptions/attitudes toward diabetes and communication with the pharmacist . This approach is consistent with the concept of pharmaceutical care in which the pharmacist helps patients avoid long-term complications and thus improve their quality of life The impact of clinical pharmacists ' consultations on geriatric drug prescribing was studied in a prospect i ve r and omized controlled trial of patients 65 years of age and over discharged on 3 or more medications for chronic conditions from a 450-bed community hospital . The pharmacists provided consultation to experimental patients and their physicians at hospital discharge and at periodic intervals for 3 months postdischarge . Using a st and ardized tool , a physician-pharmacist panel , blinded to study group assignment of patients , evaluated the appropriateness of prescribing for a r and om sample of 236 patients . Eighty-eight percent had at least one or more clinical ly significant drug problems , and 22 % had at least one potentially serious and life-threatening problem . Drug-therapy problems were divided into six categories : 1 ) inappropriate choice of therapy ; 2 ) dosage ; 3 ) schedule ; 4 ) drug-drug interactions ; 5 ) therapeutic duplication ; and 6 ) allergy . Experimental patients were less likely to have one or more prescribing problems in any of the categories ( P = 0.05 ) or in the appropriateness ( P = 0.02 ) or dosage ( P = 0.05 ) categories . A summary score , measuring the appropriateness of the patient 's total drug regimen , indicated that experimental patients ' regimens were more appropriate than those of controls ( P = 0.01 ) . Results of this trial reveal that clinical pharmacists can improve the appropriateness of geriatric drug prescribing in outpatient setting The effects of computerized drug profiles and clinical pharmacist consultation in the internal medicine clinics at a Veterans Administration hospital were studied . Population included patients ( n = 512 ) and physicians ( n = 35 ) of three internal medicine clinics during an eight-week period . The first four weeks were the preintervention period . The second four weeks were the intervention period in which a clinical pharmacist attended one clinic ( A ) and provided drug profiles on all patients . Two other clinics ( B and C ) served as controls . During the intervention , patients in clinic A experienced a significant reduction in prescribing problems as identified by the pharmacist : 49 percent of patients before the intervention versus 9.4 percent after the intervention ( p < 0.001 ) . Patients in clinic B had no significant change in prevalence in the number of problems identified ( 39 versus 40 percent ; NS ) , and patients in clinic C had a significant but less dramatic decrease ( 35 versus 22 percent ; p < 0.05 ) . The proportion of patients in clinic A with net decrease in the number of prescribed medications rose from 7.1 to 34.9 percent ( p < 0.001 ) , with a mean decrease of 0.3 medications per patient . No significant differences in number of prescribed medications were noted in clinics B or C. Accuracy of physician medication charting improved for patients in clinic A from 54 percent of charts with accurate drug lists before the intervention to 78.3 percent after the intervention ( p < 0.001 ) . No significant improvements were noted for clinics B and C. These results suggest that computerized drug profiles together with clinical pharmacist consultation can improve prescribing practice s in a hospital outpatient department . Extracto Los autores estudiaron el efecto de proveer perfiles de medicamentos computerizados y consulta por un farmaceútico clínico en las clínicas de medicina interna de un hospital de la Administración de Veteranos . La población incluyó 512 pacientes y 35 médicos de tres cl***inicas de medicina interna durante un período de ocho semanas . Las primeras cuatro semanas fue el período de pre-intervención . Las siguientes cuatro semanas fue el período de intervención en el cual un farmaceútico clínico asistió a una clínica ( A ) y proveyó perfiles de medicamentos para todos los pacientes , mientras otras dos clínicas ( B y C ) sirvieron de control . Durante la intervención los pacientes en la clínica A experimentaron una reducción significativa en los problemas de prescripción según identificados por el farmaceútico : 49 por ciento de los pacientes antes de la intervención versus 9.4 por ciento después de la intervención . Los pacientes en la clínica B no experimentaron un cambio significativo en la prevalencia del número de problemas identificados . Los pacientes en la clínica C tuvieron una disminución significativa , pero menos dramática . La proporción de pacientes en la clínica A con una disminución neta en el número de medicamentos prescritos aumentó de 7.1 por ciento a 34.9 por ciento con una disminución media de 0.3 medicamentos por paciente . No se observó una diferencia significativa en el número de medicamentos prescritos en las clínicas B y C. La precisión de las notas de medicamentos del médico mejoraron para los pacientes en la clínica A. No se observó una mejoría significativa en las clínicas B y C. Estos result ados sugieren que los perfiles de medicamentos computerizados en adición a consulta por un farmaceútico clínico pueden mejorar los patrones de prescripción en un departamento para pacientes ambulatorios de un hospital . Resume L'étude analyse l'impact de fournir le dossier-médicament des patients et de consulter avec un pharmacien clinique en médecine interne à l'hôpital Veterans Administration . Cinq cent douze sujets ont participé ainsi que les médecins ( n = 35 ) de trois cliniques en médecine interne pendant une période de huit semaines . Les quatre premières semaines constituaient la période pré-intervention . Pendant les dernières quatre semaines ( période d'intervention ) , le pharmacien clinique a participé aux activités d'une clinique ( A ) et a fourni les dossiers-médicaments pour tous les patients , alors que les deux autres cliniques ( B et C ) ont servi de contrôle . Lors de la période d'intervention , il y a eu une baisse significative pour ce qui est des problèmes de prescription pour les patients de la clinique A ( basé sur le critère modifié de King et Cheung ) : 49 pour cent des patients avant l'intervention versus 9.4 pour cent après ( p < 0.001 ) . Les patients de la clinique B n'ont eu aucun changement significatif dans la fréquence du nombre de problèmes identifiés ( 39 vs. 40 pour cent ; NS ) , et les patients de la clinique C ont vu une réduction significative mais moins dramatique ( 35 vs. 22 pour cent ; p < 0.05 ) . La proportion de patients de la clinique A avec une baisse dans le nombre de médicaments prescrits est passé de 7.1 à 34.9 pour cent ( p < 0.001 ) , avec une réduction moyenne de 0.3 médicaments par patient . Aucune différence n'a été notée pour le nombre de médicaments prescrits dans les cliniques B ou C. La précision avec laquelle le médecin a complété les dossiers s'est ameliorée pour les patients de la clinique A allant de 54 pour cent des dossiers ayant une liste correcte de médicaments avant l'intervention à 78.3 pour cent après l'intervention ( p < 0.001 ) . Aucune amélioration significative n'a été observée pour les cliniques B et C. Ces résultats démontrent que les dossiers-médicaments de patients ainsi que les consultations par le pharmacien clinique peuvent améliorer les habitudes de prescription d'un département de cliniques externes d'un hôpital OBJECTIVE : To assess the effectiveness of a pharmaceutical care model on the management of non-insulin-dependent diabetes mellitus ( NIDDM ) in urban African-American patients . DESIGN : Eligible patients were r and omized to either a pharmacist intervention or control group and followed over a 4-month period . Patients in the intervention group received diabetes education , medication counseling , instructions on dietary regulation , exercise , and home blood glucose monitoring , and evaluation and adjustment of their hypoglycemic regimen . Patients in the control group continued to receive st and ard medical care provided by their physicians . SETTING : A university-affiliated internal medicine outpat
Output:
| The other studies supported the exp and ed roles of pharmacists in patient counselling and physician education . |
MS212298 | ***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 aim of this study was to examine whether angiotensin-converting enzyme ( ACE ) inhibition improves coronary endothelial dysfunction in patients with atherosclerosis and its risk factors and whether this was related to the ACE insertion-deletion ( I/D ) polymorphism . METHODS AND RESULTS In 56 patients with atherosclerosis or its risk factors , we studied endothelium-dependent responses with acetylcholine and endothelium-independent function with sodium nitroprusside , before and after ACE inhibition with enalaprilat . Enalaprilat did not alter either resting coronary tone or vasodilation with sodium nitroprusside . However , it potentiated the coronary microvascular and epicardial responses with acetylcholine ; coronary blood flow increased from 82+/-7 to 90+/-8 mL/min ( P=0.05 ) after enalaprilat . Patients with depressed endothelial function ( P<0.001 ) and those with ACE DD or ID genotypes ( P=0.002 ) but not those homozygous for the I allele had the greatest improvement by multivariate analysis . Similarly , acetylcholine-mediated epicardial vasomotion improved in segments that initially constricted ( endothelial dysfunction ) : from -10.1+/-1 % to -1.4+/-2 % ( P<0.001 ) after enalaprilat . No augmentation was observed in segments that dilated ( normal endothelial dysfunction ) with acetylcholine . Patients with the D allele , hypercholesterolemia , and smokers ( all P<0.05 ) had greater improvement . CONCLUSIONS Acute ACE inhibition improves coronary epicardial and microvascular endothelium-dependent vasomotion in patients with atherosclerosis or its risk factors who have endothelial dysfunction and presence of the D allele CONTEXT Observational studies have shown that psychosocial factors are associated with increased risk for cardiovascular morbidity and mortality , but the effects of behavioral interventions on psychosocial and medical end points remain uncertain . OBJECTIVE To determine the effect of 2 behavioral programs , aerobic exercise training and stress management training , with routine medical care on psychosocial functioning and markers of cardiovascular risk . DESIGN , SETTING , AND PATIENTS R and omized controlled trial of 134 patients ( 92 male and 42 female ; aged 40 - 84 years ) with stable ischemic heart disease ( IHD ) and exercise-induced myocardial ischemia . Conducted from January 1999 to February 2003 . INTERVENTIONS Routine medical care ( usual care ) ; usual care plus supervised aerobic exercise training for 35 minutes 3 times per week for 16 weeks ; usual care plus weekly 1.5-hour stress management training for 16 weeks . MAIN OUTCOME MEASURES Self-reported measures of general distress ( General Health Question naire [ GHQ ] ) and depression ( Beck Depression Inventory [ BDI ] ) ; left ventricular ejection fraction ( LVEF ) and wall motion abnormalities ( WMA ) ; flow-mediated dilation ; and cardiac autonomic control ( heart rate variability during deep breathing and baroreflex sensitivity ) . RESULTS Patients in the exercise and stress management groups had lower mean ( SE ) BDI scores ( exercise : 8.2 [ 0.6 ] ; stress management : 8.2 [ 0.6 ] ) vs usual care ( 10.1 [ 0.6 ] ; P = .02 ) ; reduced distress by GHQ scores ( exercise : 56.3 [ 0.9 ] ; stress management : 56.8 [ 0.9 ] ) vs usual care ( 53.6 [ 0.9 ] ; P = .02 ) ; and smaller reductions in LVEF during mental stress testing ( exercise : -0.54 % [ 0.44 % ] ; stress management : -0.34 % [ 0.45 % ] ) vs usual care ( -1.69 % [ 0.46 % ] ; P = .03 ) . Exercise and stress management were associated with lower mean ( SE ) WMA rating scores ( exercise : 0.20 [ 0.07 ] ; stress management : 0.10 [ 0.07 ] ) in a subset of patients with significant stress-induced WMA at baseline vs usual care ( 0.36 [ 0.07 ] ; P = .02 ) . Patients in the exercise and stress management groups had greater mean ( SE ) improvements in flow-mediated dilation ( exercise : mean [ SD ] , 5.6 % [ 0.45 % ] ; stress management : 5.2 % [ 0.47 % ] ) vs usual care patients ( 4.1 % [ 0.48 % ] ; P = .03 ) . In a subgroup , those receiving stress management showed improved mean ( SE ) baroreflex sensitivity ( 8.2 [ 0.8 ] ms/mm Hg ) vs usual care ( 5.1 [ 0.9 ] ms/mm Hg ; P = .02 ) and significant increases in heart rate variability ( 193.7 [ 19.6 ] ms ) vs usual care ( 132.1 [ 21.5 ] ms ; P = .04 ) . CONCLUSION For patients with stable IHD , exercise and stress management training reduced emotional distress and improved markers of cardiovascular risk more than usual medical care alone BACKGROUND The renin-angiotensin system may contribute to atherogenesis through the promotion of endothelial dysfunction . The present study was performed to determine whether angiotensin-1 ( AT(1 ) ) receptor inhibition improves endothelial dysfunction . METHODS AND RESULTS In the femoral circulation of 19 patients with atherosclerosis and of 9 control subjects , we studied microvascular responses to reactive hyperemia , angiotensin II , acetylcholine , and sodium nitroprusside before and after the administration of intra-arterial losartan ( 10 mg ) . Femoral artery flow velocity was measured with a Doppler flow wire , and the femoral vascular resistance index ( FVRI ) was calculated as mean arterial pressure divided by flow velocity . Losartan induced a minor ( 5.9+/-2 % , P=0 . 02 ) reduction in FVRI and inhibited angiotensin II-mediated vasoconstriction in both patient groups ( P<0.01 ) . After the administration of losartan , acetylcholine-mediated vasodilation was augmented in patients ( 44+/-5 % to 58+/-4 % reduction in FVRI with infusion at a rate of 150 microgram/min , P<0.001 ) but not control subjects . Vasodilation during reactive hyperemia was also greater after AT(1 ) receptor inhibition ( P=0.03 ) in patients , but the response to sodium nitroprusside remained unchanged . In a separate group of 31 patients with atherosclerosis , we investigated the effect of 8 weeks of oral losartan therapy on brachial artery flow-mediated vasodilation with the use of high-resolution ultrasound . Oral losartan therapy improved flow-mediated brachial artery dilation ( 1.4+/-0.9 % to 3.2+/-0.8 % , P=0.03 ) but had no effect on the nitroglycerin response . Serum nitrogen oxide levels increased from 21.6+/-1.7 to 26.7+/-2.4 micromol/L ( P=0.008 ) . CONCLUSIONS The results of the present study indicate that inhibition of the AT(1 ) receptor in patients with atherosclerosis reverses endothelial dysfunction by improving NO availability and therefore may have long-term therapeutic benefits Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists Objective : To determine if depression contributes to incident heart disease after accounting for genetic , behavioral , and medical factors associated with both conditions . Methods : We used a prospect i ve twin study with a 12-year follow-up . In 1992 , lifetime diagnosis of depression was assessed in 1159 male-male twins and merged with longitudinal health data from the Vietnam Era Twin Registry Study of Aging . Incident heart disease was defined as having myocardial infa rct ion , heart surgery , or angina at 12-year follow-up when twins were 55.4 years ( st and ard deviation , 2.5 years ) of age . Risks for heart disease were computed in a logistic regression model that included comparing twins at different levels of phenotypic expression of depression and varying levels of genetic vulnerability at the same time adjusting for pertinent covariates . Results : After adjusting for sociodemographics , co-occurring psychopathology , smoking , obesity , diabetes , hypertension , and social isolation , twins at high genetic risk and exposed to depression remained at greater risk of developing ischemic heart disease ( IHD ) ( odds ratio , 2.55 ; 95 % confidence interval , 1.44 - 4.49 ) compared with those at low genetic risk and without phenotypic expression of depression . Odds ratios suggest that twins at genetic liability but without phenotypic expression were at risk of IHD , but the effect was not statistically significant . Conclusions : A history of depression is a risk factor for incident heart disease after adjusting for numerous covariates . Twins with both high genetic vulnerability and phenotypic expression of depression were at greatest risk of IHD . Trends suggest the genetic contribution to IHD that overlaps with depression may partly explain this association , but studies in larger sample s are warranted . IHD = ischemic heart disease ; VET Registry = Vietnam Era Twin Registry ; DSM-III-R = Diagnostic and Statistical Manual , Third Edition , Revised ; VETSA = Vietnam Era Twin Study of Aging ; MZ = monozygotic ; DZ = dizygotic ; MI = myocardial infa rct ion & NA ; Mental stress induces endothelial dysfunction , that is a reduction of the post‐occlusion brachial artery flow‐mediated vasodilation ( FMD ) . This does not occur in subjects highly susceptible to hypnosis ( Highs ) in either the waking or hypnotic state . The aim of the present experiment was to assess whether endothelial dysfunction is also induced by acute nociceptive stimulation and whether high hypnotisability and /or the specific instruction of analgesia prevent its occurrence in awake highly hypnotizable individuals . Thus , nine Highs and nine subjects with low susceptibility to hypnosis ( Lows ) underwent an experimental session including the administration of pressor pain and of pressor pain associated with the instruction of analgesia . Heart rate , basal artery diameters and brachial artery flow‐mediated vasodilation were measured during stimulation and rest conditions . Heart rate exhibited slight changes not modulated by hypnotisability . During painful stimulation both Highs and Lows showed a decrease of FMD , but it was significantly less pronounced in Highs . During the administration of painful stimulation together with the instruction of analgesia , only Highs reported analgesia and their FMD no longer decreased . This study provides the first evidence of pain‐related endothelial dysfunction and extends previous findings concerning a sort of natural protection of Highs against the vascular effects of mental stress to acute pain OBJECTIVES This study was design ed to investigate the role of cortisol in stress-induced endothelial dysfunction and impaired baroreflex sensitivity ( BRS ) by blocking cortisol production with metyrapone before subjecting healthy volunteers to mental stress . BACKGROUND Mental stress raises cortisol levels and is associated with increased coronary heart disease ( CHD ) morbidity and mortality , especially from sudden cardiac death . It also causes endothelial dysfunction and impaired BRS . METHODS We measured brachial artery flow-mediated dilation ( FMD ) , a measure of endothelial function , and BRS in 36 subjects without CHD risk factors who were then r and omized in a double-blind fashion to oral metyrapone 750 mg x 2 or placebo . Five hours later we subjected subjects to mental stress and then remeasured endothelial function and BRS . RESULTS Prestress cortisol levels were significantly higher in the placebo group at 270.5 ( 30.9 ) nmol/l versus 89.1 ( 11.8 ) nmol/l ( p = 0.01 ) , and the increase with stress was higher at 57.9 ( 17.9 ) nmol/l versus 11.2 ( 2.2 ) nmol/l ( p < 0.001 ) . In the placebo group , compared to baseline , FMD and BRS fell significantly from 4.5 % ( 0.7 % ) to 1.4 % ( 1.
Output:
| Circumstantial evidence indicates that mind body therapies may have a therapeutic benefit on endothelial dysfunction , however , the aggregate data from the three small r and omized trials to date do not support this hypothesis . |
MS212299 | ***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 Postoperative surgical site infections are one of the most frequent complications after open abdominal surgery , and triclosan-coated sutures were developed to reduce their occurrence . The aim of the PROUD trial was to obtain reliable data for the effectiveness of triclosan-coated PDS Plus sutures for abdominal wall closure , compared with non-coated PDS II sutures , in the prevention of surgical site infections . METHODS This multicentre , r and omised controlled group-sequential superiority trial was done in 24 German hospitals . Adult patients ( aged ≥18 years ) who underwent elective midline abdominal laparotomy for any reason were eligible for inclusion . Exclusion criteria were impaired mental state , language problems , and participation in another intervention trial that interfered with the intervention or outcome of this trial . A central web-based r and omisation tool was used to r and omly assign eligible participants by permuted block r and omisation with a 1:1 allocation ratio and block size 4 before mass closure to either triclosan-coated sutures ( PDS Plus ) or uncoated sutures ( PDS II ) for abdominal fascia closure . The primary endpoint was the occurrence of superficial or deep surgical site infection according to the Centers for Disease Control and Prevention criteria within 30 days after the operation . Patients , surgeons , and the outcome assessors were masked to group assignment . Interim and final analyses were by modified intention to treat . This trial is registered with the German Clinical Trials Register , number DRKS00000390 . FINDINGS Between April 7 , 2010 , and Oct 19 , 2012 , 1224 patients were r and omly assigned to intervention groups ( 607 to PDS Plus , and 617 to PDS II ) , of whom 1185 ( 587 PDS Plus and 598 PDS II ) were analysed by intention to treat . The study groups were well balanced in terms of patient and procedure characteristics . The occurrence of surgical site infections did not differ between the PDS Plus group ( 87 [ 14·8 % ] of 587 ) and the PDS II group ( 96 [ 16·1 % ] of 598 ; OR 0·91 , 95 % CI 0·66 - 1·25 ; p=0·64 ) . Serious adverse events also did not differ between the groups-146 of 583 ( 25·0 % ) patients treated with PDS Plus had at least one serious adverse event , compared with 138 of 602 ( 22·9 % ) patients treated with PDS II ; p=0·39 ) . INTERPRETATION Triclosan-coated PDS Plus did not reduce the occurrence of surgical site infection after elective midline laparotomy . Innovative , multifactorial strategies need to be developed and assessed in future trials to reduce surgical site infections . FUNDING Johnson & Johnson Medical Limited A r and omized controlled trail in 374 patients requiring emergency appendicectomy to determine the value of topical ampicillin and antiseptic solution of chlorhexidine and cetyl trimethyl ammonium bromide ( Savlon ) in preventing wound infection is reported . The application of 1 g of ampicillin powder to the wound significantly reduced wound infection in perforated appendicitis , but not in unperforated appendicitis . Wound irrigation with 1 per cent cetyl trimethyl ammonium bromide was ineffective in preventing wound infection in all grade s of appendicitis . When wound contamination is difficult to avoid , as in perforated appendicitis , topical ampicillin should be used to reduce the rate of wound infection Objective To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery . Design Multicentre observer blinded r and omised controlled trial . Participants Patients undergoing laparotomy at 21 UK hospitals . Interventions St and ard care or the use of a wound edge protection device during surgery . Main outcome measures Surgical site infection within 30 days of surgery , assessed by blinded clinicians at seven and 30 days and by patient ’s self report for the intervening period . Secondary outcomes included quality of life , duration of stay in hospital , and the effect of characteristics of the patient and operation on the efficacy of the device . Results 760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group . Six patients in the device group and five in the control group did not undergo laparotomy . Fourteen patients , seven in each group , were lost to follow-up . A total of 184 patients experienced surgical site infection within 30 days of surgery , 91/369 ( 24.7 % ) in the device group and 93/366 ( 25.4 % ) in the control group ( odds ratio 0.97 , 95 % confidence interval 0.69 to 1.36 ; P=0.85 ) . This lack of benefit was consistent across wound assessment s performed by clinicians and those reported by patients and across all secondary outcomes . In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device . Conclusions Wound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy , and therefore their routine use for this role can not be recommended . Trial registration Current Controlled Trials IS RCT N This study sought to determine in a district general hospital ( a ) the frequency and nature of bacterial contamination at operation , ( b ) the incidence of consequent infection and ( c ) the prophylactic effect , if any , of inter‐parietal povidone‐iodine against postoperative wound infection This study compared the efficacy of a single intravenous dose of Cefazolin alone or combined with an antibiotic containing preclosure-irrigation solution in patients undergoing cesarean section . A total of 308 patients were prospect ively assigned to two groups by r and omization . Group I received two grams of Cefazolin IV and abdomino-peritoneal irrigation with saline . Group II received one gram of Cefazolin IV and one gram in the saline irrigation solution . The rate of total postoperative morbidity was 2.3 times higher in Group I compared to Group II ( 16/154 or 10.4 % vs 7/154 or 4.5 % ) and morbidity at the operative site was six times higher ( 13/154 or 8.4 % vs 2/154 or 1.3 % ) One hundred ninety patients with peritonitis at the time of abdominal surgery were allocated at r and om to systemic antibiotic treatment alone or systemic antibiotic treatment combined with topical application of antibiotics in the wound at the time of wound closure . The overall wound infection rate was 17 percent without significant difference between the two treatment groups ( P>0.80 ) To evaluate syringe pressure irrigation of the surgical wound to decrease its infection after appendectomy , we design ed a r and omized control trial at the Emergency Department of Mexico City General Hospital , including 350 patients with acute abdomen suggestive of appendicitis , without any other infection clinical ly evident . The trial was r and omized into 2 groups . Group I patients received prophylactic systemic antibiotics before surgery . Group II patients received the same prophylactic systemic antibiotics plus syringe pressure irrigation of the surgical wound with 300 ml of saline solution using a 20-ml syringe with 19-gauge intravenous ( IV ) catheter to measure the incidence of postoperative wound infection . In our results , 283 patients had appendicitis . Of these , 188 were uncomplicated ( 66.4 % ) and 95 ( 33.6 % ) were complicated . Of the complicated cases , 40 were assigned to group I , and of these , 29 ( 72.5 % ) developed wound infection . In group II there were 55 patients and only 9 ( 16.3 % ) developed wound infection after syringe pressure irrigation [ p= 0.000001 ; 95 % confidence interval ( CI ) = 0.02–0.22 ] . We conclude that syringe pressure irrigation of the surgical wound after appendectomy contributes significantly to decrease the incidence of postoperative wound infection in complicated cases . It is a cheap , safe , and accessible method in any surgical room In this prospect i ve , r and omized study of 187 patients undergoing a variety of general surgical procedures , no significant difference could be demonstrated between those patients whose wounds were irrigated with normal saline solution and those whose wounds were irrigated with povidone-iodine . The potential of an alpha or a beta error is discussed No carefully controlled trial of the use of topical ampicillin in cholecystectomy wounds has been described . A series of 100 consecutive cholecystecomies performed by one surgeon using this drug in a double‐blind manner is reported . The efficacy of topical ampicillin in lowering the wound‐infection rate as shown by other authors is not confirmed The wound-infection rate after abdominal operations was compared in 113 patients r and omly allocated to an untreated control group , a group receiving preoperative lincomycin and tobramycin , or a group receiving local instillation of povidone-iodine . The wound-infection rate was 8.1 % in 37 patients receiving antibiotics , 42.1 % in 38 untreated controls , and 39.5 % in 38 patients in the povidone-iodine group The effect of povidone iodine on wound sepsis following gastrointestinal surgery was studied in a trial involving 153 patients of whom 72 had their wounds sprayed with povidone iodine dry powder ( Disadine DP ) and 81 acted as a control group . The infection rate of 9·9 per cent in the patients treated with povidone iodine was significantly lower than that of 24·4 per cent in the control group ( P<0·05 ) . Bacterial contamination of the wound at the time of operation was shown to be of importance , being associated with a 52 per cent infection rate in the control group . However , spraying of contaminated wounds with povidone iodine reduced the infection rate to the significantly lower level of 11 per cent ( P<0·05 ) . We conclude that povidone iodine is a safe and effective means of reducing wound sepsis following gastrointestinal surgery A r and omized stratified clinical trial of topical povidone‐iodine in 627 patients undergoing abdominal procedures demonstrated a reduction in postoperative wound sepsis in female patients , in patients receiving subcutaneous low dose heparin and during the first quarter of the trial when the infection rate in control subjects was high . Overall , there was no significant reduction in wound sepsis after administration of povidone‐iodine due mainly to a high infection rate in povidone‐iodine treated male appendix operations where , by chance , there was an increased incidence of contamination with Bacteroides fragilis Single doses of clindamycin hydrochloride and gentamicin sulfate given preoperatively , combined with intraoperative topical application of povidone-iodine were given to patients with perforated or gangrenous appendicitis . The incidence of wound sepsis was reduced from 36 % to 5 % ; severe infections were reduced from 25 % to 0 % when compared with a control untreated group of patients . When used alone , povidone-iodine had little effect in these patients . No toxic effects of the antibiotics or antiseptic were recorded nor were any resistant strains of pathogenic organisms grown from cultures OBJECTIVE To evaluate whether saline wound irrigation decreases the incidence of wound infection following abdominal gynecologic surgery . METHOD In this prospect i ve r and omized study , 104 patients underwent wound irrigation before wound closure following abdominal gynecologic surgery and 102 patients did not . RESULTS There were no significant differences between the 2 groups in patient characteristics or in factors influencing the incidence of wound infection after abdominal gynecologic surgery . The incidence of wound infection was 10.6 % among women who underwent wound irrigation and 9.8 % among those who did not , and the difference was not statistically significant . CONCLUSION Saline wound irrigation before abdominal wall closure is not helpful in decreasing the incidence of wound infection after abdominal gynecologic surgery In a prospect i ve blind trial in patients undergoing intraabdominal surgery , instillation of povodone iodine ( PVI ) solution into the wound failed to reduce the incidence of wound sepsis The effect of using topical povidone-iodine spray in addition to a single dose of intravenous metronidazole was studied in a clinical trial involving 200 patients undergoing appendicectomy . Despite the metronidazole , patients with perforated or gangrenous appendices still had an unacceptably high rate of wound infection . Overall , no benefit result ed from the addition of the povidone-iodine spray . Sub-dividing the patients according to the macroscopic state of the appendix , the degree of bacterial contamination of the operative wound or the depth of subcutaneous fat also failed to reveal any advantage gained by using the antiseptic The aim of this prospect i ve r and omised study was to estimate the effect of saline wound irrigation before wound closure in the prevention of infection following caesarean delivery . Participants with indications for elective or emergency caesarean section were r and omly allocated to two groups . A total of 260 women who underwent wound irrigation before wound closure and 2
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| Subgroup analyses showed that this effect was strongest in colorectal surgery and that IOWI with antibiotic solutions had a stronger effect than irrigation with PVP-I or saline .
Conclusion These results suggest that IOWI before skin closure represents a pragmatic and economical approach to reduce postoperative SSI after abdominal surgery and that antibiotic solutions seem to be more effective than PVP-I solutions or simple saline , and it might be worth to re-evaluate their use for specific indications |
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