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MS213100 | ***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 It is not established to what extent caloric intake must be reduced to lower oxidative stress in humans . The aim of this study was to determine the effect of short-term , moderate caloric restriction on markers of oxidative stress and inflammation in overweight and obese premenopausal women . Material s/ Methods R and omized trial comparison of 25 % caloric restriction ( CR ) or control diet in 40 overweight or obese women ( body mass index 32±5.8 kg/m2 ) observed for 28 days and followed for the next 90 days . Weight , anthropometry , vali date d markers of oxidative stress ( F2-isoprostane ) and inflammation ( C-reactive protein ) , adipokines , hormones , lipids , interleukins , and blood pressure were assessed at baseline , during the intervention , and at follow-up . Results Baseline median F2-isoprostane concentration ( 57.0 , IQR = 40.5–79.5 ) in the CR group was 1.75-fold above average range for normal weight women ( 32.5 pg/ml ) . After starting of the caloric restriction diet , F2-isoprostane levels fell rapidly in the CR group , reaching statistical difference from the control group by day 5 ( median 33.5 , IQR = 26.0–48.0 , P<0.001 ) and remained suppressed while continuing on the caloric restriction diet . Three months after resuming a habitual diet , concentrations of F2-isoprostane returned to baseline elevated levels in ∼80 % of the women . Conclusions Oxidative stress can be rapidly reduced and sustained through a modest reduction in caloric intake suggesting potential health benefits in overweight and obese women . Trial Registration Clinical trials.gov The purpose of this trial was to determine whether exercise without weight loss would reduce F2-isoprostanes in previously sedentary young women . Participants ( N=319 ) were r and omized to four months of 150min/week aerobic exercise or a control group . Plasma free F2-isoprostanes were measured by gas chromatography-mass spectrometry . Other assessment s included fitness and % body fat . Intervention groups were compared with stratification by quartiles of baseline plasma F2-isoprostane . This stratified comparison was linearly adjusted for baseline plasma F2-isoprostane and we also used baseline plasma F2-isoprostane as a propensity score to balance the intervention . Training result ed in significant improvements in aerobic fitness ( 0.88 METs ) and body fat percent ( 1 % ) in exercisers compared to controls ( p<0.001 ) . The exercise group had significantly higher mean baseline plasma F2-isoprostanes ( 79.1 vs 67.9pg/mL ) than the control group in the highest quartile of baseline plasma F2-isoprostanes . Within this highest quartile , exercise led to a greater decline in plasma F2-isoprostanes ( -20.2±2.5pg/mL ) than control ( -7.4±2.5pg/mL ) ; with adjustment for baseline plasma F2-isoprostanes and in the balanced groups , this difference was reduced but remained significant . Four months of exercise training result ed in significant reductions of systemic oxidative stress only among previously sedentary young women who were in the highest quartile of plasma F2-isoprostanes at baseline ( ≥57pg/mL ) . Our findings indicate that the benefits of aerobic exercise in reducing systemic oxidative stress may be limited to those who present higher baseline levels of plasma F2-isoprostanes Objective Investigate the effects of 12 months of dietary weight loss and /or aerobic exercise on leukocyte telomere length in postmenopausal women . Design and Methods 439 overweight or obese women ( 50–75 y ) were r and omized to : i ) dietary weight loss ( N=118 ) ; ii ) aerobic exercise ( N=117 ) , iii ) diet + exercise ( N=117 ) , or iv ) control ( N=87 ) . The diet intervention was a group-based program with a 10 % weight loss goal . The exercise intervention was 45 mins/day , 5 days/week of moderate-to-vigorous aerobic activity . Fasting blood sample s were taken at baseline and 12 months . DNA was extracted from isolated leukocytes and telomere length was measured by quantitative-polymerase chain reaction ( qPCR ) . Mean changes were compared between groups ( intent-to-treat ) using generalized estimating equations . Results Baseline telomere length was inversely associated with age ( r=−0.12 p<0.01 ) and positively associated with maximal oxygen uptake ( r=0.11 , p=0.03 ) , but not with BMI or % body fat . Change in telomere length was inversely correlated with baseline telomere length ( r=−0.47 , p<0.0001 ) . No significant difference in leukocyte telomere length was detected in any intervention group compared to controls , nor was the magnitude of weight loss associated with telomere length at 12 months . Conclusions Twelve-months of dietary weight loss and exercise did not change telomere length in postmenopausal women Oxidative stress is higher in obese diabetic than in non-diabetic subjects . This pilot study evaluates oxidative stress during short-term administration of a very low calorie diet in obese persons . Nine obese Type 2 diabetic patients ( age 55+/-5 years , BMI 35.9+/-1.9 kg/m2 ) and nine obese non-diabetic control subjects ( age 52+/-6 years , BMI 37.3+/-2.1 kg/m2 ) were treated by a very low calorie diet ( 600 kcal daily ) during 8 days stay in the hospital . Serum cholesterol , triglycerides , non-esterified fatty acids ( NEFA ) , beta-hydroxybutyrate ( B-HB ) , ascorbic acid ( AA ) , alpha-tocopherol ( AT ) , plasma malondialdehyde ( MDA ) and superoxide dismutase ( SOD ) activity in erythrocytes were measured before and on day 3 and 8 of very low calorie diet administration . A decrease of serum cholesterol and triglyceride concentrations on day 8 was associated with a significant increase of NEFA ( 0.30+/-0.13 vs. 0.47+/-0.11 micromol/l , p<0.001 ) and B-HB ( 0.36+/-.13 vs. 2.23+/-1.00 mmol/l , p<0.001 ) in controls but only of B-HB ( 1.11+/-0.72 vs. 3.02+/-1.95 mmol/l , p<0.001 ) in diabetic patients . A significant decrease of plasma MDA and serum AT together with an increase of SOD activity and AA concentration ( p<0.01 ) was observed in control persons , whereas an increase of SOD activity ( p<0.01 ) was only found in diabetic patients after one week of the very low calorie diet . There was a significant correlation between NEFA or B-HB and SOD activity ( p<0.01 ) . We conclude that one week of a very low calorie diet administration decreases oxidative stress in obese non-diabetic but only partly in diabetic persons . Diabetes mellitus causes a greater resistance to the effects of a low calorie diet on oxidative stress Oxidative stress , a potential mechanism linking obesity and cancer , results from an imbalance between activation/inactivation of reactive oxygen species , byproducts of cellular metabolism . In a r and omized controlled trial , we investigated effects of diet and /or exercise on biomarkers of oxidative stress . A total of 439 overweight/obese [ body mass index ( BMI ) > 25 kg/m2 ] postmenopausal women , ages 50 of 75 years , were r and omized to 12 months of ( i ) reduced-calorie weight loss diet ( “ diet ” ; n = 118 ) ; ( ii ) moderate-to-vigorous intensity aerobic exercise ( “ exercise ” ; n = 117 ) ; ( iii ) combined diet and exercise intervention ( “ diet + exercise ” ; n = 117 ) ; or ( iv ) control ( n = 87 ) . Outcomes were circulating markers of oxidative stress , including fluorescent oxidation products ( FOP ) , F2-isoprostanes , and oxidized low-density lipoprotein ( LDL ) . On average , participants were 57.9 years , with a BMI of 30.9 kg/m2 . F2-isprostanes were significantly reduced in the diet ( −22.7 % , P = 0.0002 ) and diet + exercise ( −23.5 % , P < 0.0001 ) arms versus controls ( −2.99 % ) and nonsignificantly reduced in the exercise arm ( −14.5 % , P = 0.01 ) . Participants r and omized to the diet and diet + exercise arms had significant increases in levels of FOP [ control −5.81 % ; diet + 14.77 % ( P = 0.0001 ) ; diet + exercise + 17.45 % , ( P = 0.0001 ) ] . In secondary analyses , increasing weight loss was statistically significantly associated with linear trends of greater reductions in oxidized LDL and in F2-isoprostanes and increases in FOP . Compared with controls , exercise participants whose maximal oxygen consumption increased had significant decreases in levels of F2-isoprostanes and in oxidized LDL and increases in FOP . Dietary weight loss , with or without exercise , significantly reduced some markers of oxidative stress in postmenopausal women . Cancer Prev Res ; 9(11 ) ; 835–43 . © 2016 AACR AIM Effects of dietary weight loss on endothelial function , particularly when combined with exercise training , is largely unknown in type 2 diabetes . We sought to determine whether aerobic exercise training provided any additional improvements in endothelial function , oxidative stress or other established markers of cardiovascular risk when combined with an energy-restricted diet in patients with type 2 diabetes . METHODS In a parallel study design , 29 sedentary , overweight and obese patients with type 2 diabetes ( age 52.4 + /- 1.4 years and BMI 34.2 + /- 0.9 kg/m(2 ) ) were r and omized to a 12-week moderate energy-restricted diet ( ~5000 kJ/day and approximately 30 % energy deficit ) with or without aerobic exercise training [ diet only ( D ) , n = 16 and diet plus exercise ( DE ) , n = 13 ] . Body weight , cardiovascular risk markers , malondialdehyde ( MDA , oxidative stress marker ) , 24-h urinary nitrate/nitrite and flow-mediated dilatation ( FMD ) of the brachial artery were measured pre- and postintervention . RESULTS Both interventions reduced body weight ( D 8.9 % , DE 8.5 % , time effect p < 0.001 ) . Significant reductions in body fat , waist circumference , blood pressure , glycated haemoglobin , glucose , insulin resistance , lipids and MDA and increases in urinary nitrite/nitrate were observed in both groups ( time effect p < or = 0.05 ) ; however , these changes were not different between treatments . At baseline , FMD was similar in both groups ( D 2.5 + /- 0.9 % , DE 4.2 + /- 1.2 % ; p = 0.25 ) and did not change after the interventions ( p = 0.59 ) . CONCLUSIONS These results suggest that lifestyle interventions incorporating diet with or without exercise improve glycaemic control , reduce oxidative stress and improve other cardiovascular risk factors but do not improve FMD in obese subjects with type 2 diabetes INTRODUCTION Maintenance of normal weight and higher levels of physical activity are associated with a reduced risk of several types of cancer . Because genomic instability is regarded as a hallmark of cancer development , one proposed mechanism is improvement of DNA repair function . We investigated links between dietary weight loss , exercise , and str and break rejoining in an ancillary study to a r and omized-controlled trial . METHODS Overweight/obese postmenopausal women ( n = 439 ) were r and omized to the following : a ) reduced calorie weight loss diet ( " diet , " n = 118 ) , b ) moderate- to vigorous-intensity aerobic exercise ( " exercise , " n = 117 ) , c ) a combination ( " diet + exercise , " n = 117 ) , or d ) control ( n = 87 ) . The reduced calorie diet had a 10 % weight loss goal . The exercise intervention consisted of 45 min of moderate to vigorous aerobic activity 5 d·wk for 12 months . DNA repair capacity was measured in a subset of 226 women at baseline and 12 months from cryopreserved peripheral mononuclear cells using the comet assay . Anthropometric and body composition measures were performed at baseline and 12 months . RESULTS DNA repair capacity did not change significantly with any of the 12-month interventions compared with control ; there were also no significant changes when stratified by changes in body composition or aerobic fitness ( V˙O2max ) . At baseline , DNA repair capacity was positively associated with weight , body mass index , and fat mass ( r = 0.20 , P = 0.00
Output:
| Results : Across a broad range of intervention design s , diet- , exercise- , surgery- , balloon-induced weight loss regimens decreased oxidative stress measures .
Conclusion : While this systematic review supports a role for intentional weight loss in reducing obesity-associated oxidative stress , it is not clear whether the effects are primary outcomes or secondary to improvement in obesity-associated insulin resistance and /or chronic inflammation . |
MS213101 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: In the voluntary contractions , output force can be maintained constant although the inhibitory influences exerted by pain on muscle activity . We investigated changes in the spontaneous and evoked activity of the abductor digiti minimi muscle ( ADM ) and the biceps brachii muscle ( BIC ) in healthy volunteers during constant force noxious contraction , result ing from chemically activated nociceptive afferents . EMG-force relationship , motor-evoked response ( MEP ) to transcranial magnetic stimulation and determinism ( DET ) of surface EMG signals during constant force contraction was analyzed before , during and after chemically induced tonic activation of their nociceptive afferents . Under constant force contraction , amplitude of surface EMG signal decreased in BIC and increased in ADM during pain with respect to control condition . In both muscles , the size of motor-evoked potential ( MEP ) induced by transcranial magnetic stimulation ( TMS ) of the primary motor cortex was significantly higher during pain than in control . Level of determinism extracted from surface EMG signal by non-linear method was similarly and significantly increased in both muscles during pain stimulation . Finally , nociceptive stimulation caused a decline in steadiness of the force exerted by ADM and BIC . These results are interpreted in terms of increased corticospinal synchronizing inputs . The possibility that it may play a role in governing force production to counteract pain inhibitory influences on motor system is considered The human cerebral processing of noxious input from skin and muscle was compared with the use of positron emission tomography with intravenous H2(15)O to detect changes in regional cerebral blood flow ( rCBF ) as an indicator of neuronal activity . During each of eight scans , 11 normal subjects rated the intensity of stimuli delivered to the nondominant ( left ) forearm on a scale ranging from 0 to 100 with 70 as pain threshold . Cutaneous pain was produced with a high-energy CO2 laser stimulator . Muscle pain was elicited with high-intensity intramuscular electrical stimulation . The mean ratings of perceived intensity for innocuous and noxious stimulation were 32.6 + /- 4.5 ( SE ) and 78.4 + /- 1.7 for cutaneous stimulation and 15.4 + /- 4.2 and 73.5 + /- 1.4 for intramuscular stimulation . The pain intensity ratings and the differences between noxious and innocuous ratings were similar for cutaneous and intramuscular stimuli ( P > 0.05 ) . After stereotactic registration , statistical pixel-by-pixel summation ( Z score ) and volumes-of-interest ( VOI ) analyses of subtraction images were performed . Significant increases in rCBF to both noxious cutaneous and intramuscular stimulation were found in the contralateral secondary somatosensory cortex ( SII ) and inferior parietal lobule [ Brodmann area ( BA ) 40 ] . Comparable levels of rCBF increase were found in the contralateral anterior insular cortex , thalamus , and ipsilateral cerebellum . Noxious cutaneous stimulation caused significant activation in the contralateral lateral prefrontal cortex ( BA 10/46 ) and ipsilateral premotor cortex ( BA 4/6 ) . Noxious intramuscular stimulation evoked rCBF increases in the contralateral anterior cingulate cortex ( BA 24 ) and subsignificant responses in the contralateral primary sensorimotor cortex ( MI/SI ) and lenticular nucleus . These activated cerebral structures may represent those recruited early in nociceptive processing because both forms of stimuli were near pain threshold . Correlation analyses showed a negative relationship between changes in rCBF for thalamus and MI/SI for cutaneous stimulation , and positive relationships between thalamus and anterior insula for both stimulus modalities . Direct statistical comparisons between innocuous cutaneous and intramuscular stimulation with the use of Z scores and VOI analyses showed no reliable differences between these two forms of noxious stimulation , indicating a substantial overlap in brain activation pattern . The comparison of noxious cutaneous and intramuscular stimulation indicated more activation in the premotor cortex , SII , and prefrontal cortex with cutaneous stimulation , but these differences did not reach statistical significance . The similar cerebral activation patterns suggest that the perceived differences between acute skin and muscle pain are mediated by differences in the intensity and temporospatial pattern of neuronal activity within similar sets of forebrain structures Although pathological muscle pain involves a significantly larger population than any other pain condition , the central mechanisms are less explored than those of cutaneous pain . The aims of the study were to establish the pain matrix for muscle pain in the full head volume and , further , to explore the possibility of a functional segregation to nonpainful and painful stimuli within the area of the parasylvian cortex corresponding to the secondary somatosensory area . Additionally , we speculate that a r and omization of nonpainful and painful stimuli may target specific structures related to stimulus salience . We used event-related functional magnetic resonance imaging ( MRI ) and the high sensitivity of the 3-T MRI scanner to study the central processing of acute muscle pain induced by intramuscular electrostimulation . Brief nonpainful and painful stimuli ( 1-ms duration , interstimulus interval = 12 s ) were r and omly applied to the left abductor pollicis brevis of 10 subjects . The data disclose a pain matrix for muscle pain similar to that for cutaneous pain . Individual analysis suggests separate representations within the area bounded by the upper bank of the Sylvian fissure ( SF ) and the circular sulcus of insula ( CSI ) . Nonpainful stimulation activated the superficial parietal operculum adjoining the SF , while the painful condition additionally targeted the deeper parietal operculum bordering the CSI . R and omization of stimuli of different intensities likely introduces cognitive components that engage neural substrates servicing the appreciation of stimulus salience in the context of affect-laden pain imposition Abstract All pain is unpleasant , but different perceptual and emotional qualities are characteristic of pain originating in different structures . Pain of superficial ( cutaneous ) origin usually is sharp and restricted , whereas pain of deep origin ( muscle/viscera ) generally is dull and diffuse . Despite the differences it has been suggested previously that all pain is mediated by an invariant set ( ‘ neuromatrix ’ ) of brain structures . However , we report here , using functional magnetic resonance imaging ( fMRI ) , that striking regional differences in brain activation patterns were the rule . Signal differences were found in regions implicated in emotion ( perigenual cingulate cortex ) , stimulus localization and intensity ( somatosensory cortex ) and motor control ( motor cortex , cingulate motor area ) . Further , most fMRI signal changes matched perceived changes in pain intensity . These findings clearly indicate that distinct neural activity patterns in distinct sets of brain structures are evoked by pain originating from different tissues of the body . Further , we suggest that these differences underlie the different perceptual and emotional reactions evoked by deep versus superficial pain OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity Training is a mainstay in the clinical management of neck pain , yet , effects of various training protocol s are only small to moderate and improvements are required . Previous investigations of the nervous system indicate a correlation between neuroplastic adaptation to training and functional recovery . The interaction between neck pain and training thus needs further exploration . This was a r and omized experimental study of the effects of experimental neck pain and training on corticomotor excitability . Healthy volunteers were r and omized to training and experimental neck pain , training and no pain , and pain and no training . Primary endpoints were corticomotor excitability assessed by transcranial magnetic stimulation and electromyography measured as changes in amplitudes and latencies of motor evoked potentials ( MEPs ) , recorded at baseline and after 30 min , 1 h , and 1 week . Additionally , correlations between changes in MEPs and motor learning , effects of pain and concomitant neck training on pain , muscle strength , and fatigue were investigated . Data were analyzed by repeated measurement ANOVA , paired t tests , Grubbs ' outlier test and correlation coefficients . Results indicated that neck pain and training significantly enhanced the inhibition of the amplitudes of the MEPs for 1 week . The results indicate that moderate neck pain and training induce long-lasting inhibition of the corticomotor pathways . This inhibition may limit the outcome of neck training in painful conditions in contrast to pain-free training conditions Earlier investigations have shown that stimulation of peripheral afferent nerves induces prolonged changes in the excitability of the human motor cortex . The present study compared the effect of experimental pain and non-painful conditioning stimulation on motor evoked potentials ( MEPs ) elicited by transcranial magnetic stimulation ( TMS ) in the relaxed first dorsal interosseous ( FDI ) and flexor carpi ulnaris ( FCU ) muscles . The MEPs were measured in 10 healthy subjects , and stimulus-response curves were generated before and after each of four stimulation paradigms conducted in r and om order on separate occasions : ( a ) control ; ( b ) " dual stimulation " consisting of electrical stimulation of the FDI motor point paired with TMS ; ( c ) painful infusion of hypertonic saline in the FDI muscle ; and ( d ) pain combined with dual stimulation . There were no significant changes in FDI MEPs following the control paradigm , and dual stimulation induced an increase in the FDI MEPs only inconsistently . In contrast , the painful stimulation and the combined pain and dual stimulation paradigms were followed by significant suppression of the FDI MEPs at higher stimulus intensities . No changes were observed in the FCU MEPs following the four paradigms . In two additional subjects , the responses evoked in FDI by direct stimulation of the descending corticospinal tracts were significantly depressed following painful stimulation of the FDI , although the ulnar-evoked M-waves remained constant . It is concluded that muscle pain is followed by a period with profound depression of MEPs amplitudes in the resting muscle , but that these changes are at least in part due to a lasting depression of the excitability of the motoneurones in the spinal cord . Hence , painful stimulation differs from non-painful , repetitive stimulation , which facilitates the corticomotor pathway UNLABELLED Excitability of the motor cortex can be suppressed during muscle pain . Yet the mechanisms are largely unknown . Short interval intracortical inhibition ( SICI ) and intracortical facilitation ( ICF ) were examined as possible c and i date mechanisms to underpin this change . SICI and ICF were investigated in 11 healthy individuals before , during and after infusion of hypertonic saline into right first dorsal interosseous ( FDI ) . Using paired-pulse transcranial magnetic stimulation ( TMS ) , interstimulus intervals of 2 , 3 , and 13 ms were investigated . Pain intensity and quality were recorded using a 10-cm visual analogue scale and the McGill Pain Question naire . Resting motor threshold and motor-evoked potentials ( MEPs ) to single TMS stimuli were recorded before and after pain . Electromyographic recordings were made from right FDI and abductor digiti minimi . Participants reported an average pain intensity of 5.8 ( 1.6 ) cm . MEP amplitudes decreased in both muscles . Compared with the pre-pain condition , SICI was increased following pain , but not during . ICF was decreased both during and after pain when compared with the pre-pain condition . These findings suggest that muscle pain differentially modulates SICI and ICF . Although the functional relevance is unknown , we hypothesize decreased facilitation and increased inhibition may contribute to the restriction of movement of a painful body part . PERSPECTIVE This article provides evidence for decreased intracortical facilitation and increased short interval intracortical inhibition in response to muscle pain . This finding is
Output:
| Meta-analyses of TMS and EEG data revealed moderate to strong evidence of reduced S1 and corticomotor excitability during and following the resolution of muscle pain .
Overall , the findings of this review indicate reduced S1 and corticomotor activity during and after resolution of acute muscle pain , mechanisms that could plausibly underpin altered sensorimotor function in pain .
Through meta-analyses we evaluate the strength of evidence concerning the direction and temporal profile of the S1/M1 response to acute muscle pain |
MS213102 | ***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 an intervention to improve food label knowledge and skills in diabetes management among older adults with diabetes mellitus . DESIGN A r and omized pretest-posttest control group design was used . SUBJECTS/ SETTING Participants ( 48 experimental , 50 control ) were aged 65 years and older with type 2 diabetes for 1 year or longer ; 93 participants ( 95 % ) completed the study , conducted in an outpatient setting . INTERVENTION The intervention included 10 weekly group sessions led by a dietitian . Information processing , learning theory , and Social Cognitive Theory principles were used in program development and evaluation . MAIN OUTCOME MEASURES Participants ' knowledge , outcome expectations ( expected results of behavior ) , self-efficacy , and decision-making skills were assessed . Instrument validity and reliability were established before program evaluation . STATISTICAL ANALYSES PERFORMED Factor analysis identified underlying factor structures . Analysis of covariance with pretest score as covariate was used to compare groups at posttest . Paired t tests compared results within groups . RESULTS Two factors were identified for outcome expectations ( positive and negative ) and for self-efficacy ( promoters of and barriers to diabetes management ) . The experimental group had greater improvement in total knowledge scores ( mean + /- st and ard error of the mean : 7.8+/-0.7 ) than the control group ( 0.2+/-0.7 ) ( P < .0001 ) , positive outcome expectations ( 0.59+/-0.15 vs 0.06+/-0.15 , P = .01 ) , promoters of diabetes management ( 0.83+/-0.12 vs -0.09+/-0.18 , P < or = .001 ) and decision-making skills ( 5.1+/-0.5 vs 0.3+/-0.5 , P < .0001 ) and greater reduction in barriers to diabetes management ( 1.1+/-0.16 vs 0.34+/-0.16 , P < .01 ) . No significant difference in negative outcome expectations occurred between groups at posttest . APPLICATIONS/ CONCLUSIONS Older adults with diabetes can benefit from nutrition education design ed to improve knowledge and skills necessary for diabetes management Purpose . Examine the effects of three iterative tailored feedback letters addressing smoking ; physical activity ; and fruit , vegetable , and fat intake , and test the additional effects of providing feedback on action plans . Design . A tailored , print-based intervention was developed and tested in a r and omized control trial with a posttest after 9 months . Setting . A total of 2827 respondents agreed to participate . They were recruited from a r and om sample of 35,000 addresses obtained through the Dutch national telephone company . Subjects . The mean age was 49 years , and 55 % were female . Intervention . The experimental group received three printed tailored letters , and the control group received three printed generic letters . Respondents from the experimental group r and omly received either a third letter with tailored information or tailored information and action-planning feedback . Measures . The question naire assessed physical activity ; smoking ; consumption of fruit , vegetables and fat ; motivational determinants ; action plans ; and demographics . Results . Tailored information result ed in more improvement over time than generic information for the intake of fruit , vegetables , and fat and for physical activity . No differences between the conditions were found for smoking because of high cessation rates in all conditions . Action-planning feedback did not increase the effects . Conclusions . Tailored lifestyle information can be effective for adults in changing nutrition behavior and physical activity BACKGROUND Few primary care physicians routinely counsel for exercise , despite the benefits of physical activity and the high prevalence of inactivity . The objective of this study is to assess the effectiveness of Physician-Based Assessment and Counseling for Exercise ( PACE ) , a brief , behavior-based tool for primary care providers counseling healthy adults . METHODS This study is a r and omized controlled trial of 812 patients age 30 years or older registered for well visits at 32 primary care physician offices at a staff model health maintenance organization . Intervention physicians were trained to deliver PACE exercise counseling protocol s at the index visit , and one reminder telephone call occurred at 1 month . An enhanced intervention group received additional activity reminders . RESULTS At the 6-month follow-up , the control group did not differ significantly from the intervention group for energy expended ( 2,048 kcal/week versus 2,108 kcal/ week , P = 0.77 ) , time spent in walking or other moderate to vigorous activities ( 202 min/week versus 187 min/ week , P = 0.99 ) , mental health , physical function , or behaviors previously shown to predict activity change . Among the intervention patients , the stages-of-change score for Contemplators increased significantly compared with controls ( P = 0.03 ) , but without a significant change in energy expended . Baseline levels of physical activity counseling were high ( 50 % ) , as were baseline patient physical activity levels ( 61 % exercised at least three times a week ) . CONCLUSIONS These results suggest that a one-time PACE counseling session with minimal reinforcement , in a setting with high baseline levels of activity , does not further increase activity . The finding that Contemplators advanced in stage of behavior change suggests that further studies are needed to examine long-term , repeated counseling interventions Background Although experts cl aim that computer-tailored interventions provided over the Internet have great potential to promote health behavior change , few studies have tested the efficacy of computer-tailored lifestyle interventions online-delivered over the Internet . Purpose To evaluate the short-term ( 1 month ) efficacy of an Internet-delivered , computer-tailored lifestyle intervention targeting saturated fat intake , physical activity ( PA ) , and smoking cessation , and to evaluate exposure to the intervention . Methods A pretest – posttest r and omized controlled trial with an intervention group and a no intervention waiting list control group was conducted . Self-reported behavior and determinants were assessed at baseline and 1 month follow-up . Exposure to the intervention was monitored through server registration s. The data were analyzed using multiple linear and logistic regression analysis . Results The intervention result ed in a significantly lower self-reported saturated fat intake ( b = −0.76 , p < 0.01 ) and a higher likelihood of meeting the PA guidelines among respondents who were insufficiently active at baseline ( OR = 1.34 , 95%CI = 1.001–1.80 ) . No significant intervention effects were found for self-reported smoking status . Of the participants , 81 % actually visited the website . Conclusions The Internet-delivered , computer-tailored lifestyle intervention was effective in reducing self-reported saturated fat intake and in increasing self-reported PA among participants who completed the study Sedentary behavior among older adults increases risk for chronic diseases . Physicians in a primary care setting can play an important role in promoting physical activity adoption among their older patients . The Physically Active for Life ( PAL ) project was a r and omized , controlled trial comparing the efficacy of brief physician-delivered physical activity counseling to usual care on self-reported physical activity levels . The physical activity counseling was based on the Transtheoretical Model of Change and social learning theory . Twenty-four community-based primary care medical practice s were recruited into the study ; 12 were r and omized to the Intervention condition and 12 to the Control condition . Physicians in the Intervention practice s received training in the delivery of brief physical activity counseling . Subjects in the Intervention practice s ( n=181 ) received brief activity counseling matched to their stage of motivational readiness for physical activity , a patient manual , a follow-up appointment with their physician to discuss activity counseling , and newsletter mailings . Subjects in the Control practice s ( n=174 ) received st and ard care . Measures of motivational readiness for physical activity and the Physical Activity Scale for the Elderly ( PASE ) were administered to subjects in both conditions at baseline , 6 weeks following their initial appointment , and at 8 months . Results showed that at the 6-week follow-up , subjects in the Intervention condition were more likely to be in more advanced stages of motivational readiness for physical activity than subjects in the Control condition . This effect was not maintained at the 8 month follow-up and the intervention did not produce significant changes in PASE scores . Results suggest that more intensive , sustained interventions may be necessary to promote the adoption of physical activity among sedentary , middle-aged , and older adults in primary care medical practice Purpose The purpose of this study was to evaluate the community-based Chronic Disease Self-management Program ( CDSMP ) and the Spanish- language version ( Tom and o Control de Su Salud ) programs as delivered in setting s along the Texas/New Mexico/Mexico border . The programs had proven effective in r and omized trials , and the authors wished to determine if they would be as effective when administered by others to different population s. Methods The El Paso Diabetes Association administered the CDSMP and Tom and o to 445 persons with chronic illness ( two thirds with diabetes ) in Texas , New Mexico , and Mexico . Four-month and 1-year outcomes were compared to baseline using t tests of change scores . Regression models were used to test whether baseline demographics and self-efficacy were associated with positive outcomes of the programs . Results Participants showed improvements in health behaviors , health status , and self-efficacy at both 4 month and 1 year . Baseline self-efficacy and 4-month change in self-efficacy were significantly associated with improved 1- year outcomes . Conclusions The CDSMP and Tom and o are effective when used in setting s other than that of the original study for population s other than those for which they were initially developed This study compared the efficacy of two low-cost interventions for physical activity adoption . Sedentary ( N=194 ) adults recruited through newspaper advertisements were r and omized to receive either a motivationally-matched , individually-tailored intervention ( IT ) or a st and ard self-help intervention ( ST ) . Assessment s and interventions were delivered by repeated mailings at baseline , one , three , and six months . Participants were assessed regarding current physical activity behavior , motivational readiness to adopt regular physical activity , and psychological constructs associated with physical activity participation ( e.g. self-efficacy , decisional balance ) . Repeated measures analyses of variance ( ANOVAs ) revealed significant increases in physical activity participation between baseline and six months for both groups with a significantly greater increase among IT participants . The IT group outperformed the ST group on all primary outcome measures : ( a ) minutes of physical activity per week , ( b ) reaching Centers for Disease Control and American College of Sports Medicine ( CDC/ACSM ) recommended minimum physical activity criteria , and ( c ) achieving the Action stage of motivational readiness for physical activity adoption . Both groups showed significant improvement between baseline and six months on the psychological constructs associated with physical activity adoption ( e.g. self-efficacy ) , with no significant differences observed between the treatment groups . Utilizing computer expert systems and self-help manuals to provide individually-tailored , motivationally-matched interventions appears to be an effective , low-cost approach for enhancing physical activity participation in the community BACKGROUND Rates of physical inactivity and poor nutrition , which are 2 of the most important modifiable risk factors for cardiovascular disease in women , are substantial . Even so , studies of interventions design ed to improve lifestyle behaviors in women have been limited and often confined to particular geographical areas . OBJECTIVE To evaluate the effect of Choose to Move on increasing women 's physical activity , improving their knowledge of heart disease and stroke , and improving their nutrition . PARTICIPANTS AND METHODS A prospect i ve , nonr and omized , 12-week educational intervention design ed by the American Heart Association for women across the United States . Participants received a welcome kit and manual with weekly information about how to manage cardiovascular disease risk factors and how to build a support system for lifestyle change . Women ( N = 23 171 ) aged 25 years or older were recruited by direct mail , the media , health care providers , and other means . Follow-up evaluations were returned from 6389 women at 2 weeks , 5338 at 4 weeks , 4209 at 8 weeks , 3916 at 10 weeks , and 3775 at 12 weeks . Participants self-reported their physical activity , diet , and knowledge about heart disease , stroke , and related symptoms . RESULTS Ninety percent of the participants were white and 56 % were aged between 35 and 54 years . Among the participants who completed the week 12 follow-up evaluation , the percentage who reported being active ( at least moderate exercise > or = 5 times per week or > 2(1/2 ) hours per week for the past 1 to 6 months ) increased from 32 % at baseline to 67 % at the program 's end ( P = .001 ) . Participants currently limiting excess calories or fat increased from 72 % to 91 % at week 10 follow-up evaluation ( P = .001 ) . The proportion correctly identifying heart disease as the leading cause of death increased from 84 % to 91 % at week 10 follow-up evaluation ( P<.001 ) . CONCLUSIONS Women who completed the Choose to Move program evaluation reported that they significantly increased their levels of physical activity , reduced their consumption of high-fat foods , and increased their knowledge and awareness of cardiovascular disease risk and its symptoms . This program provides an important model for public health , voluntary , and other health organizations of population -based , targeted low-cost self-help programs that support the Healthy People 2010 objectives for physical activity , nutrition , and cardiovascular health Chronic obstructive pulmonary disease ( COPD ) is disabling , with symptoms such as chronic cough , phlegm , wheezing , shortness of breath and increased infections of the respiratory passage . The aim was to examine
Output:
| Most of the studies ( 71 % , 37/52 ) demonstrated an improvement in health literacy , in particular interventions of a moderate to high intensity .
Non medical health care providers were effective in improving health literacy .
However this was confounded by intensity of intervention .
Provider barriers impacted on their relationship with patients .
Conclusion Capacity to provide interventions of sufficient intensity is an important condition for effective health literacy support for lifestyle change . |
MS213103 | ***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 was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms , quality of life , and costs , and to investigate the effect of patient preference on uptake and outcome of treatment . Methods A pragmatic , multi-centre r and omised controlled trial in five British National Health Service physiotherapy departments . 174 women with stress and /or urge incontinence were r and omised to receive treatment from a physiotherapist delivered in a group or individual setting over three weekly sessions . Outcome were measured as Symptom Severity Index ; Incontinence-related Quality of Life question naire ; National Health Service costs , and out of pocket expenses . Results The majority of women expressed no preference ( 55 % ) or preference for individual treatment ( 36 % ) . Treatment attendance was good , with similar attendance with both service delivery models . Overall , there were no statistically significant differences in symptom severity or quality of life outcomes between the models . Over 85 % of women reported a subjective benefit of treatment , with a slightly higher rating in the individual compared with the group setting . When all health care costs were considered , average cost per patient was lower for group sessions ( Mean cost difference £ 52.91 95 % , confidence interval ( £ 25.82 - £ 80.00 ) ) . Conclusion Indications are that whilst some women may have an initial preference for individual treatment , there are no substantial differences in the symptom , quality of life outcomes or non-attendance . Because of the significant difference in mean cost , group treatment is recommended . Trial Registration Trial Registration number : IS RCT N PURPOSE to compare the effects of functional electrostimulation of the pelvic floor and therapy with cones in women with stress urinary incontinence ( SUI ) . METHODS r and omized clinical study for which 45 patients with SUI were selected . The effects of functional electrostimulation of the pelvic floor were evaluated in the SUI treatment of 24 women , with the use of clinical data ( micturition diary , pad test and a question naire about quality of life - I-QoL ) . The patients were su bmi tted to two 20 ' weekly sessions for four consecutive months , under the supervision of a physiotherapist . The electrode used had 10 cm length and 3.5 cm width with a double metallic ring and a cylindrical shape , positioned in the medium third of the vagina . The electric parameters used were : intensity varying from 10 to 100 mA and 50 Hz of fixed frequency , with pulse duration of 1 ms . Also , we evaluated 21 patients who were su bmi tted to vaginal cone treatment . The cone therapy was done with two 45 minute sessions per week . The cones ' weight varied from 20 to 100 gr . RESULTS there was no difference between the outcomes of electrostimulation of the pelvic floor and the vaginal cones for the treatment of SUI ( p>0.05 ) . After four months , there was a significant improvement in the I-QoL index of the patients treated both with electrostimulation ( 40.3 versus 82.9 ) or with the cones ( 47.7 versus 84.1 ) . There was a significant decrease in pad weight in both groups , measured before and after the treatment ( 28.5 and 32 g versus 2.0 and 3.0 g for the electrostimulation and cone group , respectively ) . Finally , there was a significant decrease in the number of urinary leakage evaluated by the micturition diary in both groups ( p<0.0001 ) . CONCLUSIONS both electrostimulation and vaginal cones were effective in the treatment of women with SUI OBJECTIVE To evaluate the effects of surface electrical stimulation ( SES ) and to compare them with the effects of the intravaginal electrical stimulation ( IVES ) in women with stress urinary incontinence ( SUI ) . STUDY DESIGN This r and omized controlled study included 48 women aged over 50 years , who complained of SUI evaluated according to two structured questions of King 's Health Question naire ( KHQ ) and who had not previously undergone physical therapy for SUI . The calculation of the sample size estimated a sample of 45 volunteers with a significance level of 5 % and statistical power of 90 % . The women were r and omized to : Surface Electrical Stimulation Group ( SESG ) ( n=15 ) , Intravaginal Electrical Stimulation Group ( IVESG ) ( n=15 ) and Control Group ( CG ) ( n=15 ) . Subjects in the intervention groups were treated with the same parameters of electrical stimulation for 12 sessions . The SESG had four silicone electrodes fixed in the suprapubic and ischial tuberosity regions . The IVES group used an intravaginal electrode . The CG did not receive any treatment during the corresponding time . They were evaluated before and after treatment by a physical therapist who was blind to group allocation . The primary outcomes were urinary leakage , pressure and strength of pelvic floor muscle ( PFM ) contraction . The secondary outcome was quality of life ( QOL ) evaluated by KHQ . Forty-five women completed the study and were included in the analysis . Statistical analysis was performed using the Wilcoxon test for intragroup analysis and Kruskal-Wallis and Mann-Whitney tests for intergroup analysis ( p<0.05 ) . RESULTS There was significant improvement in urinary loss and pressure of contraction in the SESG and IVESG . PFM strength increased only in the IVESG . Intergroup analysis found differences after the treatment in : urinary leakage between the SESG and CG ( p<0.001 ) and the IVESG and CG ( p<0.001 ) . Regarding QOL , there was significant reduction in the incontinence impact , limitations of daily activities , physical limitation , emotion , sleep and disposition and severity domains in the SESG ( all p<0.02 ) and IVESG ( all p<0.04 ) after the treatments . CONCLUSION SES and IVES are important treatments to improve the SUI . Both improved the QOL , urinary leakage , and strength and pressure of PFM contraction PURPOSE To compare the effectiveness of pelvic floor exercises , electrical stimulation , vaginal cones , and no active treatment in women with urodynamic stress urinary incontinence . PATIENTS AND METHODS One hundred eighteen subjects were r and omly selected to recieve pelvic floor exercises ( n=31 ) , ES ( n=30 ) , vaginal cones ( n=27 ) , or no treatment ( untreated control ) ( n=30 ) . Women were evaluated before and after completion of six months of treatment by the pad test , quality of life question naire ( I-QOL ) , urodynamic test , voiding diary , and subjective response . RESULTS In the objective evaluation , we observed a statistically significant reduction in the pad test ( p=0.003 ) , in the number of stress urinary episodes ( p<0.001 ) , and a significant improvement in the quality of life ( p<0.001 ) in subjects who used pelvic floor exercises , electrical stimulation , and vaginal cones compared to the control group . No significant difference was found between groups in the urodynamic parameters . In the subjective evaluation , 58 % , 55 % , and 54 % of women who had used pelvic floor exercises , electrical stimulation , and vaginal cones , respectively , reported being satisfied after treatment . In the control group , only 21 % patients were satisfied with the treatment . CONCLUSION Based on this study , pelvic floor exercises , electrical stimulation , and vaginal cones are equally effective treatments and are far superior to no treatment in women with urodynamic stress urinary incontinence Introduction and hypothesisPelvic floor muscle training ( PFMT ) is a treatment for stress urinary incontinence ( SUI ) that can be done individually or in a group . The aim of this study was to compare these two types of treatment . Methods Sixty women 30 to 75 years old with SUI were r and omly assigned to participate in the two groups . They were evaluated before and after the treatment with the Oxford grading system , pad test , voiding diary , and the King ’s Health Question naire . Results Both groups experienced significant reductions in urinary leakage as measured by the pad test and bladder diary . A negative pad test was observed in about 50 % of patients in both groups . There were statistically significant improvements in both muscle strength and quality of life . When the groups were compared , there were no differences in the results between them . Conclusions Individual treatment and group PFMT appear to be equally effective for improving SUI Abstract Objective : To compare the effect of pelvic floor exercises , electrical stimulation , vaginal cones , and no treatment for genuine stress incontinence . Design : Stratified , single blind , r and omised controlled trial . Setting : Multicentre . Participants : 107 women with clinical ly and urodynamically proved genuine stress incontinence . Mean ( range ) age was 49.5 ( 24 - 70 ) years , and mean ( range ) duration of symptoms 10.8 ( 1 - 45 ) years . Interventions : Pelvic floor exercise ( n=25 ) comprised 8 - 12 contractions 3 times a day and exercise in groups with skilled physical therapists once a week . The electrical stimulation group ( n=25 ) used vaginal intermittent stimulation with the MS 106 Twin at 50 Hz 30 minutes a day . The vaginal cones group ( n=27 ) used cones for 20 minutes a day . The untreated control group ( n=30 ) was offered the use of a continence guard . Muscle strength was measured by vaginal squeeze pressure once a month . Main outcome measures : Pad test with st and ardised bladder volume , and self report of severity . Results : Improvement in muscle strength was significantly greater ( P=0.03 ) after pelvic floor exercises ( 11.0 cm H2O ( 95 % confidence interval 7.7 to 14.3 ) before v 19.2 cm H2O ( 15.3 to 23.1 ) after ) than either electrical stimulation ( 14.8 cm H2O ( 10.9 to 18.7 ) v 18.6 cm H2O ( 13.3 to 23.9 ) ) or vaginal cones ( 11.8 cm H2O ( 8.5 to 15.1 ) v 15.4 cm H2O ( 11.1 to 19.7 ) ) . Reduction in leakage on pad test was greater in the exercise group ( −30.2 g ; −43.3 to 16.9 ) than in the electrical stimulation group ( −7.4 g ; −20.9 to 6.1 ) and the vaginal cones group ( −14.7 g ; −27.6 to −1.8 ) . On completion of the trial one participant in the control group , 14 in the pelvic floor exercise group , three in the electrical stimulation group , and two in the vaginal cones group no longer considered themselves as having a problem . Conclusion : Training of the pelvic floor muscles is superior to electrical stimulation and vaginal cones in the treatment of genuine stress incontinence Introduction and hypothesisTo compare the effects of pelvic floor muscle training ( PFMT ) , with or without biofeedback ( BF ) , for stress urinary incontinence ( SUI ) , focusing on condition-specific quality of life ( QOL ) outcomes . Methods Women with SUI were r and omized to PFMT with BF ( BF group , n = 23 ) or without BF ( PFMT group , n = 23 ) for 12 weeks . As primary outcome measures , subjective symptoms and QOL were assessed by the King ’s Health Question naire ( KHQ ) and International Consultation on Incontinence Question naire-Short Form ( ICIQ-SF ) . A voiding diary , 1-h pad test , and measurement of PFM strength were secondary outcome measures . Changes in the primary and secondary outcomes were assessed before and after 12 weeks ’ exercise training . Results Of the 9 domains of the KHQ , the scores of 5 significantly decreased in the PFMT group , and the scores of 7 significantly decreased in the BF group . All ICIQ-SF items and the total score significantly decreased in both groups after therapy . The number of incontinence episodes significantly decreased in the PFMT group , and tended to decrease in the BF group , but this was not significant ( P = 0.054 ) . The leakage volume in the 1-h pad test tended to decrease in both groups , but was not significant . Maximum vaginal squeeze pressure significantly increased in both groups . There were no significant inter-group differences in the changes in any of the parameters assessed . Conclusions The results indicate that PFMT is effective for treating SUI . There is no apparent add-on effect of BF training in short-term follow-up OBJECTIVE : The aim of this study was to compare the effectiveness of multimodal supervised physiotherapy programs with the absence of treatment among women with persistent postnatal stress urinary incontinence . METHODS : This was a single-blind r and omized controlled trial . Sixty-four women with stress urinary incontinence were r and omly assigned to 8 weeks of either multimodal pelvic floor rehabilitation ( n = 21 ) , multimodal pelvic floor rehabilitation with abdominal muscle training ( n = 23 ) , or control non – pelvic floor rehabilitation ( n = 20 ) . The primary outcome measure consisted of a modified 20-minute pad test . The secondary outcome measures included a Visual Analog Scale describing the perceived burden of incontinence , the Urogenital Distress Inventory , the Incontinence Impact Question naire , and pelvic floor muscle function measurements . RESULTS : Two patients dropped out , leaving 62 for analysis . At follow-up , more than 70 % of the women in the treatment groups ( 14/20 in the pelvic floor and 17/23 in the pelvic floor plus abdominal group ) were continent on pad testing compared with 0 % of women in the control
Output:
| Combining biofeedback with PFMT had an uncertain effect on QoL ( MD = -4.4 points ; CI 95 % = -16.69 to 7.89 points ) , but better results on the pad test , although with elevated heterogeneity ( MD = 0.9 g ; 95%CI = 0.71 to 1,10 g ) ; group PFMT was not less efficacious than individual treatment , and home PFMT was not consistently worse than supervised PFMT .
Both intravaginal and superficial electrical stimulation ( IES and SES ) were better than no treatment for QoL and pad test .
The association of IES with PFMT may improve the efficacy of the latter for QoL and pad test , but the results of individual studies were not consistent .
Thus , there is evidence of the use of PFMT on the treatment of SUI , with and without biofeedback |
MS213104 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: PURPOSE The purpose of this r and omized trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction for Breast Cancer ( MBSR[BC ] ) program in improving psychological and physical symptoms and quality of life among breast cancer survivors ( BCSs ) who completed treatment . Outcomes were assessed immediately after 6 weeks of MBSR(BC ) training and 6 weeks later to test efficacy over an extended timeframe . PATIENTS AND METHODS A total of 322 BCSs were r and omly assigned to either a 6-week MBSR(BC ) program ( n = 155 ) or a usual care group ( n = 167 ) . Psychological ( depression , anxiety , stress , and fear of recurrence ) and physical symptoms ( fatigue and pain ) and quality of life ( as related to health ) were assessed at baseline and at 6 and 12 weeks . Linear mixed models were used to assess MBSR(BC ) effects over time , and participant characteristics at baseline were also tested as moderators of MBSR(BC ) effects . RESULTS Results demonstrated extended improvement for the MBSR(BC ) group compared with usual care in both psychological symptoms of anxiety , fear of recurrence overall , and fear of recurrence problems and physical symptoms of fatigue severity and fatigue interference ( P < .01 ) . Overall effect sizes were largest for fear of recurrence problems ( d = 0.35 ) and fatigue severity ( d = 0.27 ) . Moderation effects showed BCSs with the highest levels of stress at baseline experienced the greatest benefit from MBSR(BC ) . CONCLUSION The MBSR(BC ) program significantly improved a broad range of symptoms among BCSs up to 6 weeks after MBSR(BC ) training , with generally small to moderate overall effect sizes In a r and omized controlled design , this study tested the efficacy of a theoretically based uncertainty management intervention delivered to older long-term breast cancer survivors . The sample included 509 recurrence-free women ( 360 Caucasian , 149 African-American women ) with a mean age of 64 years ( S.D.=8.9 years ) who were 5 - 9 years post-treated for breast cancer . Women were r and omly assigned to either the intervention or usual care control condition . The intervention was delivered during four weekly telephone sessions , in which study nurses guided cancer survivors in the use of audiotaped cognitive-behavioral strategies to manage uncertainty about recurrence , and a self-help manual design ed to help women underst and and manage long-term treatment side effects and other symptoms . Treatment outcome data on uncertainty management were gathered at pre-intervention and 10-months afterward . Repeated measures MANOVA evaluating treatment group , ethnic group , and treatment by ethnic interaction effects indicated that training in uncertainty management result ed in improvements in cognitive reframing , cancer knowledge , patient-health care provider communication , and a variety of coping skills . Results are discussed in terms of the importance of theory-based interventions for cancer survivors that target triggers of uncertainty about recurrence and in terms of ethnic differences in response to the intervention Purpose : The purpose of this sub study of a large r and omized controlled trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction ( Breast Cancer ) ( MBSR[BC ] ) program compared to usual care ( UC ) in normalizing blood levels of pro-inflammatory cytokines among breast cancer survivors ( BCS ) . Method : A total of 322 BCS were r and omized to either a 6-week MBSR(BC ) program or a UC . At baseline and 6 and 12 weeks , 10 ml of venous blood and demographic and clinical data were collected and /or up date d. Plasma cytokines ( interleukin [IL]-1β , IL-6 , IL-10 , tumor necrosis factor [ TNF ] α , transforming growth factor [ TGF ] β1 , soluble tumor necrosis factor receptor [ sTNFR ] 1 ) were assayed . Linear mixed models were used to assess cytokine levels across three time points ( baseline and 6 and 12 weeks ) by group ( MBSR[BC ] vs. UC ) . Results : Of the six measured cytokines , three were nondetectable at rates greater than 50 % ( IL-10 , IL-1β , TGF-β1 ) and , because of overall low prevalence , were not analyzed further . For the remaining cytokines ( TNFα , IL-6 , sTNFR1 ) , results showed that TNFα and IL-6 increased during the follow-up period ( between 6 and 12 weeks ) rather than during the MBSR(BC ) training period ( between baseline and 6 weeks ) , while sTNFR1 levels did not change significantly across the 12-week period . Conclusions : Study results suggest that MBSR(BC ) affects cytokine levels in BCS , mainly with increases in TNFα and IL-6 . The data further suggest that B-cell modulation may be a part of immune recovery during breast cancer management and that increases in TNFα and IL-6 may be markers for MBSR(BC)-related recovery Background : Recent literature has indicated that a significant percentage of oncology patients describe finding some benefit ( e.g. , improved personal growth , sense of meaning , and enhanced interpersonal relationships ) in the cancer experience . However , few studies have investigated the role of group-based psychosocial interventions in improving benefit finding ( BF ) , and virtually none have investigated these constructs in men . Purpose : This study examined whether a cognitive-behavioral stress management ( CBSM ) intervention improves BF and quality of life ( QoL ) in men recovering from treatment for localized prostate cancer . Methods : Participants in this study were 191 men ( M age = 65.1 ) treated with radiation or radical prostatectomy for clinical ly localized ( i.e. , Stage I or II ) prostate cancer . Participants were primarily non-Hispanic White ( 40 % ) or Hispanic ( 41 % ) , followed by Black ( 18 % ) and other ethnicity ( 1 % ) , were an average of 65.1 years old ( SD = 7.7 ) , and earned an average of $ 47,800 annually ( SD = $ 41,000 ) . Participants were r and omized to either a 10-week group-based cognitive-behavioral stress management intervention or a half-day educational seminar as a control condition . All participants provided demographic information and completed the Positive Contributions Scale-Cancer to assess BF , the Functional Assessment of Cancer Therapy to measure quality of life , and a measure of perceived stress management skills . Structural equation modeling was utilized for all analyses . Results : Results indicated that the CBSM condition led to increases in BF and QoL and that these changes were mediated by the development of stress management skills . Conclusions : Results support the use of group-based cognitive-behavioral interventions in promoting QoL and BF in this population Background There are few interventions for couples facing cancer . Purpose This study aims to investigate the utility of providing dyadic skills to these couples . Methods Woman recently diagnosed with breast or gynecological cancer and their partners were r and omly assigned to either a couple-skills intervention ( Side by Side ) or to cancer education ( Couples Control Program ) . Assessment s with self-report and behavioral observation of both partners were conducted four times over 16 months . Results Multilevel analyses of data from 72 participating couples suggest that females receiving Side by Side showed larger reductions in fear of progression , and couples reported less avoidance in dealing with the cancer , more posttraumatic growth , and better relationship skills relative to the Couples Control Program . All differences favoring Side by Side disappeared by 16 months after the diagnosis . ConclusionS hort-term changes in functioning may be improved by enhancing couples ’ dyadic skills during acute medical treatment of the disease 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 OBJECTIVE In a pilot r and omized controlled trial , examine the feasibility and preliminary efficacy of an 8-week , mindfulness training program ( Mindfulness Based Stress Reduction ) in a sample of men on active surveillance on important psychological outcomes including prostate cancer anxiety , uncertainty intolerance and posttraumatic growth . METHODS Men were r and omized to either mindfulness ( n = 24 ) or an attention control arm ( n = 19 ) and completed self-reported measures of prostate cancer anxiety , uncertainty intolerance , global quality of life , mindfulness and posttraumatic growth at baseline , 8 weeks , 6 months and 12 months . RESULTS Participants in the mindfulness arm demonstrated significant decreases in prostate cancer anxiety and uncertainty intolerance , and significant increases in mindfulness , global mental health and posttraumatic growth . Participants in the control condition also demonstrated significant increases in mindfulness over time . Longitudinal increases in posttraumatic growth were significantly larger in the mindfulness arm than they were in the control arm . CONCLUSIONS While mindfulness training was found to be generally feasible and acceptable among participants who enrolled in the 8-week intervention as determined by completion rates and open-ended survey responses , the response rate between initial enrollment and the total number of men approached was lower than desired ( 47 % ) . While larger sample sizes are necessary to examine the efficacy of mindfulness training on important psychological outcomes , in this pilot study posttraumatic growth was shown to significantly increase over time for men in the treatment group . Mindfulness training has the potential to help men cope more effectively with some of the stressors and uncertainties associated with active surveillance . Copyright © 2016 John Wiley & Sons , PURPOSE / OBJECTIVES To determine whether breast cancer survivors ( BCSs ) who received an uncertainty management intervention , compared to an attention control condition , would have less uncertainty , better uncertainty management , fewer breast cancer-specific concerns , and more positive psychological outcomes . DESIGN A 2 × 2 r and omized block , repeated- measures design , with data collected at baseline and two other points postintervention , as well as a few days before or after either a mammogram or oncologist visit . SETTING Rural and urban clinical and community setting s. SAMPLE 313 female BCSs aged 50 or younger ; 117 African Americans and 196 Caucasians . METHODS Participants were blocked on ethnicity and r and omly assigned to intervention or control . The intervention , consisting of a scripted CD and a guide booklet , was supplemented by four scripted , 20-minute weekly training calls conducted by nurse interventionists . The control group received the four scripted , 20-minute weekly training calls . MAIN RESEARCH VARIABLES Uncertainty in illness , uncertainty management , breast cancer-specific concerns , and positive psychological outcomes . FINDINGS BCSs who received the intervention reported reductions in uncertainty and significant improvements in behavioral and cognitive coping strategies to manage uncertainty , self-efficacy , and sexual dysfunction . CONCLUSIONS The intervention was effective as delivered in managing uncertainties related to being a younger BCS . IMPLICATION S FOR NURSING The intervention can realistically be applied in practice because of its efficient and cost-effective nature requiring minimal direct caregiver involvement . The intervention allows survivors who are having a particular survival issue at any given point in time to access information , re sources , and management strategies . KNOWLEDGE TRANSLATION Material s tested in CD and guide booklet format could be translated into online format for survivors to access as issues arise during increasingly lengthy survivorship periods . Material s could be downloaded to a variety of electronic devices , fitting with the information needs and management styles of younger BCSs OBJECTIVE Among the most prevalent and distressing concerns endorsed by breast cancer survivors is fear of cancer recurrence ( FOR ) , and one of the most salient facets is the worry that a recurrence of cancer could cause one 's death . The primary goal of the present study was to test the effects of a brief , low-cost gratitude intervention on overall FOR and death-related FOR , positing pursuit of meaningful goals as a theoretically driven putative mediator . To replicate published tests of similar gratitude-eliciting interventions , positive affect ( PA ) was also considered as an outcome . METHOD Sixty-seven women with early stage breast cancer were r and omly assigned to either a
Output:
| CONCLUSIONS Mind-body interventions are efficacious for reducing FCR , with small-to-medium effect sizes that persist after intervention delivery ends . |
MS213105 | ***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: We have review ed the clinical and pathological diagnoses of 143 cases of parkinsonism seen by neurologists associated with the movement disorders service at The National Hospital for Neurology and Neurosurgery in London who came to neuropathological examination at the United Kingdom Parkinson 's Disease Society Brain Research Centre , over a 10-year period between 1990 and the end of 1999 . Seventy-three ( 47 male , 26 female ) cases were diagnosed as having idiopathic Parkinson 's disease ( IPD ) and 70 ( 42 male , 28 female ) as having another parkinsonian syndrome . The positive predictive value of the clinical diagnosis for the whole group was 85.3 % , with 122 cases correctly clinical ly diagnosed . The positive predictive value of the clinical diagnosis of IPD was extremely high , at 98.6 % ( 72 out of 73 ) , while for the other parkinsonian syndromes it was 71.4 % ( 50 out of 70 ) . The positive predictive values of a clinical diagnosis of multiple system atrophy ( MSA ) and progressive supranuclear palsy ( PSP ) were 85.7 ( 30 out of 35 ) and 80 % ( 16 out of 20 ) , respectively . The sensitivity for IPD was 91.1 % , due to seven false-negative cases , with 72 of the 79 pathologically established cases being diagnosed in life . For MSA , the sensitivity was 88.2 % ( 30 out of 34 ) , and for PSP it was 84.2 % ( 16 out of 19 ) . The diagnostic accuracy for IPD , MSA and PSP was higher than most previous prospect i ve clinicopathological series and studies using the retrospective application of clinical diagnostic criteria . The seven false-negative cases of IPD suggest a broader clinical picture of disease than previously thought acceptable . This study implies that neurologists with particular expertise in the field of movement disorders may be using a method of pattern recognition for diagnosis which goes beyond that inherent in any formal set of diagnostic criteria Few detailed clinico-pathological correlations of Parkinson 's disease have been published . The pathological findings in 100 patients diagnosed prospect ively by a group of consultant neurologists as having idiopathic Parkinson 's disease are reported . Seventy six had nigral Lewy bodies , and in all of these Lewy bodies were also found in the cerebral cortex . In 24 cases without Lewy bodies , diagnoses included progressive supranuclear palsy , multiple system atrophy , Alzheimer 's disease , Alzheimer-type pathology , and basal ganglia vascular disease . The retrospective application of recommended diagnostic criteria improved the diagnostic accuracy to 82 % . These observations call into question current concepts of Parkinson 's disease as a single distinct morbid entity Overdiagnosis of Parkinson 's disease ( PD ) is suggested by specialist review of community diagnosis , and in postmortem studies . In specialist centers 4 to 15 % of patients entered into clinical trials as early PD do not have functional imaging support for a PD diagnosis . In a European multicenter , prospect i ve , longitudinal study , we compared clinical diagnosis with functional SPECT imaging using [123I]FP-CIT ( DaTSCAN , GE Healthcare ) . Repeat observations were performed over 3 years in patients with tremor and /or parkinsonism in whom there was initial diagnostic uncertainty between degenerative parkinsonism and nondegenerative tremor disorders . Video-recording of clinical features was scored independently of functional imaging results by two blinded clinicians at 36 months (= gold st and ard clinical diagnosis ) . Three readers , unaware of the clinical diagnosis , classified the images as normal or abnormal by visual inspection . The main endpoint was the sensitivity and specificity of SPECT imaging at baseline compared with the gold st and ard . In 99 patients completing the three serial assessment s , on-site clinical diagnosis overdiagnosed degenerative parkinsonism at baseline in diagnostically uncertain cases compared with the gold st and ard clinical diagnosis ( at 36 months ) , the latter giving a sensitivity of 93 % and specificity of 46 % . The corresponding baseline [123I]FP-CIT SPECT results showed a mean sensitivity of 78 % and a specificity of 97 % . Inter-reader agreement for rating scans as normal or abnormal was high ( Cohen 's kappa = 0.94 - 0.97 ) Background This study examines the clinical accuracy of movement disorder specialists in distinguishing tremor dominant Parkinson 's disease ( TDPD ) from other tremulous movement disorders by the use of st and ardised patient videos . Patients and methods Two movement disorder specialists were asked to distinguish TDPD from patients with atypical tremor and dystonic tremor , who had no evidence of presynaptic dopaminergic deficit ( subjects without evidence of dopaminergic deficit ( SWEDDs ) ) according to 123I-N-ω-fluoro-propyl- 2β-carbomethoxy-3β-(4-iodophenyl ) nortropane ( [ 123I ] FP-CIT ) single photon emission computed tomography ( SPECT ) , by ‘ blinded ’ video analysis in 38 patients . A diagnosis of parkinsonism was made if the step 1 criteria of the Queen Square Brain Bank criteria for Parkinson 's disease were fulfilled . The review er diagnosis was compared with the working clinical diagnosis drawn from the medical history , SPECT scan result , long term follow-up and in some cases the known response to dopaminergic medications . This comparison allowed a calculation for false positive and false negative rate of diagnosis of PD . Results High false positive ( 17.4 - 26.1 % ) and negative ( 6.7 - 20 % ) rates were found for the diagnosis of PD . The diagnostic distinction of TDPD from dystonic tremor was reduced by the presence of dystonic features in treated and untreated PD patients . Conclusion Clinical distinction of TDPD from atypical tremor , monosymptomatic rest tremor and dystonic tremor can be difficult due to the presence of parkinsonian features in tremulous SWEDD patients . The diagnosis of bradykinesia was particularly challenging . This study highlights the difficulty of differentiation of some cases of SWEDD from PD CONTEXT Pramipexole and levodopa are effective medications to treat motor symptoms of early Parkinson disease ( PD ) . In vitro and animal studies suggest that pramipexole may protect and that levodopa may either protect or damage dopamine neurons . Neuroimaging offers the potential of an objective biomarker of dopamine neuron degeneration in PD patients . OBJECTIVE To compare rates of dopamine neuron degeneration after initial treatment with pramipexole or levodopa in early PD by means of dopamine transporter imaging using single-photon emission computed tomography ( SPECT ) with 2beta-carboxymethoxy-3beta(4-iodophenyl)tropane ( beta-CIT ) labeled with iodine 123 . DESIGN Sub study of a parallel-group , double-blind r and omized clinical trial . SETTING AND PATIENTS Eighty-two patients with early PD who were recruited at 17 clinical sites in the United States and Canada and required dopaminergic therapy to treat emerging disability , enrolled between November 1996 and August 1997 . INTERVENTIONS Patients were r and omly assigned to receive pramipexole , 0.5 mg 3 times per day with levodopa placebo ( n = 42 ) , or carbidopa/levodopa , 25/100 mg 3 times per day with pramipexole placebo ( n = 40 ) . For patients with residual disability , the dosage was escalated during the first 10 weeks , and subsequently , open-label levodopa could be added . After 24 months of follow-up , the dosage of study drug could be further modified . MAIN OUTCOME MEASURES The primary outcome variable was the percentage change from baseline in striatal [(123)I]beta-CIT uptake after 46 months . The percentage changes and absolute changes in striatal , putamen , and cau date [(123)I]beta-CIT uptake after 22 and 34 months were also assessed . Clinical severity of PD was assessed using the Unified Parkinson Disease Rating Scale ( UPDRS ) 12 hours off anti-PD medications . RESULTS Sequential SPECT imaging showed a decline in mean ( SD ) [(123)I]beta-CIT striatal uptake from baseline of 10.3 % ( 9.8 % ) at 22 months , 15.3 % ( 12.8 % ) at 34 months , and 20.7 % ( 14.4 % ) at 46 months-approximately 5.2 % per year . The mean ( SD ) percentage loss in striatal [(123)I]beta-CIT uptake from baseline was significantly reduced in the pramipexole group compared with the levodopa group : 7.1 % ( 9.0 % ) vs 13.5 % ( 9.6 % ) at 22 months ( P = .004 ) ; 10.9 % ( 11.8 % ) vs 19.6 % ( 12.4 % ) at 34 months ( P = .009 ) ; and 16.0 % ( 13.3 % ) vs 25.5 % ( 14.1 % ) at 46 months ( P = .01 ) . The percentage loss from baseline in striatal [(123)I]beta-CIT uptake was correlated with the change from baseline in UPDRS at the 46-month evaluation ( r = - 0.40 ; P = .001 ) . CONCLUSIONS Patients initially treated with pramipexole demonstrated a reduction in loss of striatal [(123)I]beta-CIT uptake , a marker of dopamine neuron degeneration , compared with those initially treated with levodopa , during a 46-month period . These imaging data highlight the need to further compare imaging and clinical end points of PD progression in long-term studies CONTEXT Since there is no diagnostic biological marker for Parkinson disease ( PD ) , the diagnosis is based on the results of clinical assessment . The accuracy of diagnosis improves with time and repeated assessment s. Studies that require only inclusion of early cases of PD present a diagnostic challenge . Previous studies concluded that initial diagnoses of PD made by general neurologists were incorrect in 24 % to 35 % of the cases when patients were examined at autopsy . Experts in movement disorders are expected to have greater accuracy of initial diagnosis of PD . OBJECTIVE To determine the evolution of clinical diagnosis in patients with early PD made initially by experts in PD . DESIGN Eight hundred patients with mild parkinsonian symptoms ( Hoehn and Yahr stage 1 or 2 ) who received a diagnosis of PD less than 5 years before the beginning of the study were included in the original Deprenyl and Tocopherol Antioxidative Therapy for Parkinson 's Disease study . These patients were followed up prospect ively with repeated clinical assessment s. The following clinical criteria were used to reassess the initial diagnosis : investigator 's confidence in the diagnosis of PD , presence of atypical clinical features , findings of imaging studies , response to levodopa , and results of autopsy examinations . RESULTS The mean + /- SD duration of illness in the 800 cases at enrollment was 2.2+/-1.3 years , and the mean + /- SD Hoehn and Yahr stage was 1.6+/-0.5 . The mean + /- SD follow-up was 6.0+/-1.4 years ( range , 0.2 - 7.6 years ) . In 5 cases , PD was not confirmed at autopsy , and in 15 patients , the results of imaging studies indicated the presence of other pathological conditions . Of the 550 cases treated with levodopa , 49 ( 8.9 % ) had little or no improvement ; 6 of these cases overlap with either autopsy or imaging study exclusion criteria . Two other cases had at least 4 of the 6 atypical clinical features arguing against the diagnosis of PD . Thus , of the 800 patients , 65 ( 8.1 % ) did not have PD according to the study criteria . Compared with those patients with the final diagnosis of PD , in the diagnoses of 60 patients without autopsy , the duration of symptoms ( mean + /- SD , 7.2+/-2.0 years vs. 8.3+/-1.9 years ; P<.001 ) and the duration of follow-up ( 5.3+/-1.6 years vs. 6.1+/-1.3 years ; P<.001 ) were shorter . CONCLUSIONS We found that 65 ( 8.1 % ) of patients initially diagnosed as having PD were later found to have an alternate diagnosis based on multifactorial clinical diagnostic criteria . This alternate diagnosis indicated that experts in PD changed their diagnoses infrequently during the 7.6-year follow-up BACKGROUND Despite the known benefit of levodopa in reducing the symptoms of Parkinson 's disease , concern has been expressed that its use might hasten neurodegeneration . This study assessed the effect of levodopa on the rate of progression of Parkinson 's disease . METHODS In this r and omized , double-blind , placebo-controlled trial , we evaluated 361 patients with early Parkinson 's disease who were assigned to receive carbidopa-levodopa at a daily dose of 37.5 and 150 mg , 75 and 300 mg , or 1
Output:
| Our systematic review indicates that DAT SPECT imaging seems to be accurate to detect nigrostriatal cell loss in patients with parkinsonism |
MS213106 | ***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 psychopharmacotherapy of somatoform disorders ( SD ; ICD-10 : F45 ) has been less frequently investigated and is not as well established as in other ( neurotic ) disorders of ICD-10 section F4 , i.e. generalized anxiety disorder ( GAD ; ICD-10 : F41.1 ) . The atypical compound opipramol is very often used to treat SD and GAD in clinical practice in Germany . However , state-of-the-art controlled clinical trials have not yet been performed . OBJECTIVES Two clinical trials were performed with the aim of confirming the efficacy and tolerability of opipramol in SD and GAD . METHODS Both trials were performed as r and omized , double-blind , placebo-controlled , multicenter studies . While the GAD trial was a three-arm study with opipramol ( 200 mg/day ) vs. placebo and alprazolam ( 2 mg/day ) for 28 days , the SD trial was a placebo-controlled two-arm study with a treatment duration of 42 days . Each group consisted of about 100 patients . RESULTS Significant differences ( alpha = 0.05 ) were found for the primary efficacy criteria ( HAMA total score in GAD , HAMA somatic subscore in SD ) and most of the secondary criteria in favor of the active drug therapies . Considerable differences between the psychopathology of SD and GAD were detected . CONCLUSION The well-tolerated anxiolytic opipramol is the first psychotropic drug with proven efficacy in somatoform disorders with effects on symptoms of somatization , anxiety , and depression . The compound is also effective and safe in GAD & NA ; In the double‐blind placebo‐controlled study presented here , the effects were investigated of a low dose of amitriptyline ( 75 mg ) in patients with chronic pain of various origins . The active drug was superior to placebo in reducing pain intensity . The reduction was small . In the second treatment week , the amitriptyline treated patients slept longer . No differences between active drug and placebo were found with respect to daily activities or use of analgesics . Based on our data and those of other studies , it is concluded that amitriptyline ( and other antidepressants ) in low doses does have a positive effect on the intensity and some other aspects of chronic pain , but that the effect is modest . It must be kept in mind that chronic pain is a very treatment‐resistant condition . Therefore , even modest positive effects may be worthwhile OBJECTIVE This pilot study explored the efficacy and tolerability of extended-release venlafaxine ( venlafaxine ER ) in anxious and /or depressed patients with multisomatoform disorder ( MSD ) . METHOD This 12-week , multicenter , r and omized , double-blind study evaluated adult primary care out patients with MSD and comorbid major depressive disorder , generalized anxiety disorder , or social anxiety disorder ( DSM-IV criteria ) . The intent-to-treat population included 112 patients ( venlafaxine ER , N = 55 ; placebo , N = 57 ) . The primary efficacy variable was the change in the 15-item Patient Health Question naire ( PHQ-15 ) somatic symptom severity score . Secondary outcomes included the Hamilton Rating Scale for Depression ( HAM-D-17 ) and for Anxiety ( HAM-A ) , Clinical Global Impressions-Severity of Illness ( CGI-S ) and -Improvement ( CGI-I ) scales , McGill Quality of Life Question naire Physical Symptoms Scale ( MQOL-PS ) , and Medical Outcomes Study Short-Form 36-Item question naire ( MOS SF-36 ) . Data were collected from April 2003 to December 2003 . RESULTS The decline by week 12 in PHQ-15 scores was significant ( p < .0001 ) in both groups ; however , the difference between the venlafaxine ER and placebo groups ( -8.3 vs. -6.6 , respectively ) was not ( p = .097 ) . Improvement was greater with venlafaxine ER than placebo on the PHQ-15 pain subscale ( p = .03 ) , SF-36 bodily pain scale ( 26.1 vs. 14.5 , p = .03 ) , MQOL-PS ( -11.7 vs. -6.0 , p = .02 ) , HAM-A psychic anxiety subscale ( p = .02 ) , SF-36 mental component summary ( p = .03 ) , time to response ( 54 vs. 71 days , p = .01 ) , and CGI-I scale ( p = .009 ) . Venlafaxine ER was generally well tolerated . CONCLUSION These results suggest that venlafaxine ER may be effective in relieving some types of somatic physical symptoms , particularly pain , in patients with depression and /or anxiety disorders Abstract Rationale and objective . Preliminary data have shown that St John 's wort might possess some specific efficacy in patients with somatoform complaints . Therefore , the efficacy of the Hypericum extract LI 160 in patients with somatoform disorders should be studied in a double-blind placebo-controlled fashion . Methods . This was a multicentre , r and omised , placebo controlled , 6-week trial comparing the efficacy of LI 160 ( 600 mg/day ) and placebo in 151 out- patients suffering from somatization disorder ( ICD-10 : F45.0 ) , undifferentiated somatoform disorder ( F45.1 ) , or somatoform autonomic dysfunctions ( F45.3 ) . The primary outcome measure was the decrease of the Hamilton Anxiety Scale , subfactor somatic anxiety ( HAMA-SOM ) , during the trial period . Results . LI 160 was superior effective concerning the primary outcome criterion HAMA-SOM [ decrease from 15.39 ( SD 2.68 ) to 6.64 ( 4.32 ) in the Hypericum group and from 15.55 ( 2.94 ) to 11.97 ( 5.58 ) in the placebo group ( statistically significant difference , P=0.001 ) ] . This was corroborated by the result of a statistically significant superior efficacy in the outcome criteria additionally used such as Clinical Global Impression , HAMA-total score , HAMA , subscore psychic anxiety , Hamilton Depression Scale , Self-Report Symptom Inventory 90 items – revised ( SCL-90-R ) , and SCL-90-R , subscore somatic anxiety . The efficacy of LI 160 was preserved after splitting the population in those with mild and those with severe depressive symptoms . Tolerability of LI 160 was excellent . Conclusion . The data from this trial show excellent efficacy and tolerability for LI 160 in somatoform disorders . The efficacy is independent of an existing depressive mood . This is the first study showing the efficacy of a drug in patients with somatisation disorder independent of depressive symptomatology The reduction of pain by two antidepressants , clomipramine and mianserin , was , in this study on 253 patients with chronic idiopathic pain syndrome , found to be not better than a placebo when all patients were compared independently of the classification of pain . The improvement rate was around 40 % after 6 weeks of treatment when using a 50 % or better reduction in pain level . However , in patients who fulfilled a checklist definition of minor to major depression ( 30 % of the total patient material ) clomipramine was superior to mianserin and placebo with an improvement rate of 75 % after 6 weeks . Using pain curves over time as outcome measure in the various clinical pain categories it was found that both mianserin and clomipramine seemed superior to placebo in patients with tension headache , but in patients with low back pain syndrome placebo was superior to the two antidepressants . No difference among the three treatments was found in patients with burning mouth syndrome or in patients with abdominal pain . These differences underline the importance of study ing specific pain syndromes rather than composite groups of patients with idiopathic pain . The clinical significance of these pain curves needs further placebo controlled investigations The effects of domperidone , a peripherally acting dopamine antagonist , were compared with those of placebo in a double-blind r and omized study in 16 patients with idiopathic gastric stasis , chronic symptoms of “ nonulcer dyspepsia ” ( including nausea , vomiting , and abdominal pain ) , and altered gastroduodenal motility . Patients received either domperidone or placebo orally ( 20 mg before meals and at bedtime ) for six weeks . Symptoms were assessed by daily diaries kept by the patients for two weeks while receiving no medication for their gastrointestinal complaints ( baseline ) , and throughout the six-week treatment phase . Studies of gastric emptying of a radiolabeled solid-phase meal were performed at baseline and six weeks after treatment . All patients had delayed gastric emptying at baseline , defined as a half-emptying time of more than mean + 1 sd ( from studies of normal controls ) . An 18- to 24-hr recording of gastroduodenal motor function during fasting was also performed at baseline and after six weeks of either domperidone or placebo treatment . After six weeks of treatment , the symptom scores significantly improved in the domperidone group ( P<0.05 ) , but not in the placebo group . Gastroduodenal motor activity was unchanged from baseline recordings after six weeks . Solid-phase gastric emptying also showed no improvement in either the domperidone or placebo group of patients . Although domperidone therapy had no significant effect on motility , it appears to be an effective drug for the treatment of the symptoms of nonulcer dyspepsia Abstract Objectives : To compare the efficacy and tolerability of Hypericum perforatum ( St John 's wort extract ) with imipramine in patients with mild to moderate depression . Design : R and omised , multicentre , double blind , parallel group trial . Setting : 40 outpatient clinics in Germany . Participants : 324 out patients with mild to moderate depression . Intervention : 75 mg imipramine twice daily or 250 mg hypericum extract ZE 117 twice daily for 6 weeks . Main outcome measures : Hamilton depression rating scale , clinical global impression scale , and patient 's global impression scale . Results : Among the 157 participants taking hypericum mean scores on the Hamilton depression scale decreased from 22.4 at baseline to 12.00 at end point ; among the 167 participants taking imipramine they fell from 22.1 to 12.75 . Mean clinical global impression scores at end point were 2.22 out of 7 for the hypericum group and 2.42 for the imipramine group . On the 7 point self assessment s of global improvement completed by participants ( score of 1 indicating “ very much improved ” and 7 indicating “ very much deteriorated ” ) mean scores were 2.44 in the hypericum group and 2.60 in the imipramine group . None of the differences between treatment groups were significant . However , the mean score on the anxiety-somatisation subscale of the Hamilton scale ( 3.79 in the hypericum group and 4.26 in the imipramine group ) indicated a significant advantage for hypericum relative to imipramine . Mean scores on the 5 point scale used by participants to assess tolerability ( score of 1 indicating excellent tolerability and 5 indicating very poor tolerability ) were better for hypericum ( 1.67 ) than imipramine ( 2.35 ) . Adverse events occurred in 62/157 ( 39 % ) participants taking hypericum and in 105/167 ( 63 % ) taking imipramine . 4 ( 3 % ) participants taking hypericum withdrew because of adverse events compared with 26 ( 16 % ) taking imipramine . Conclusions : This Hypericum perforatum extract is therapeutically equivalent to imipramine in treating mild to moderate depression , but patients tolerate hypericum better Pain possesses both sensory and affective dimensions , which are highly correlated yet distinct . Comparison of these dimensions within experimental pain setting s has result ed in the construct of relative unpleasantness . Relative unpleasantness is defined as the amount of affective unpleasantness elicited for a given sensory magnitude . The aim of this study was to determine the relationship between affective and sensory components of evoked pain in subjects with fibromyalgia ( FM ) and healthy controls . Here we show that patients with FM unexpectedly display less relative unpleasantness than healthy controls in response to r and om noxious pressure stimuli . Relative unpleasantness was not correlated with distress , anxiety , or depression , which were pronounced in the FM group . Clinical pain in patients with FM was perceived to be more unpleasant than the evoked pain stimuli . These results are consistent with the concept that chronic pain may reduce the relative unpleasantness of evoked pain sensations BACKGROUND The German National Health Interview and Examination Survey ( GHS ) is the first government m and ated nationwide study to investigate jointly the prevalence of somatic and mental disorders within one study in the general adult population in Germany . This paper reports results from its Mental Health Supplement ( GHS-MHS ) on 4-week 12-month , and selected lifetime prevalence of a broad range of DSM-IV mental disorders , their co-morbidity and correlates in the community . METHODS The sample of the GHS-MHS ( n=4181 ; multistage stratified r and om sample drawn from population registries ; conditional response rate : 87.6 % ) can be regarded as representative for the German population aged 18 - 65 . Diagnoses are based on fully structured computer assisted clinical interviews ( M-CIDI ) , conducted by clinical ly trained interviewers
Output:
| The current review found very low- quality evidence for NGAs and low- quality evidence for NPs being effective in treating somatoform symptoms in adults when compared with placebo .
Furthermore , the significant effects of antidepressant treatment have to be balanced against the relatively high rates of adverse effects .
Adverse effects produced by medication can have amplifying effects on symptom perceptions , particularly in people focusing on somatic symptoms without medical causes .
We can only draw conclusions about short-term efficacy of the pharmacological interventions because no trial included follow-up assessment s. For each of the comparisons where there were available data on acceptability rates ( NGAs versus placebo , NPs versus placebo , TCAs versus other medication , and antidepressants versus a combination of an antidepressant and an antipsychotic ) , no clear differences between the intervention and comparator were found . |
MS213107 | ***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 Approximately 80 percent of pregnant women suffer by some degree of nausea and vomiting . But the treatment of nausea and vomiting of pregnancy is rarely successful . Objectives The aim of this study was evaluation the effect of mint on nausea and vomiting during pregnancy that its treatment in some recent research has been effective . Material s and Methods In this double blind RCT , 60 pregnant women with nausea and vomiting of pregnancy were sample d and divided into two groups with Block-r and omized method . mint group , in addition to giving the routine training , for four consecutive nights , before sleeping , a bowel of water whit four drops of pure mint essential oil placed on the floor near their beds and in control groups were used four drops of normal saline . The severity of nausea by using Visual Analog Scale ( VAS ) and severity of vomiting by counting the number of its in 7 days prior , 4 days during , and 7 days after intervention were assessed . Results The results showed that the severity of nausea and vomiting did not differ between the two groups in 7days before and after intervention by using repeated measurement test . But during intervention , the severity of nausea showed a decreasing trend ( especially in 4th night ) in the mint and an increasing trend in the control group . The severity of nausea within 7 days after the intervention had a decreasing trend in both groups ; however , the intensity was lower in the mint than saline group but not statically significant . No meaningful relationship has been detected during and after intervention for the intensity of vomiting . Conclusions The results of study showed that peppermint essential oil has n't the effect on nausea and vomiting of pregnancy OBJECTIVE To evaluate the effectiveness of Diclectin ( doxylamine succinate 10 mg-pyridoxine hydrochloride 10 mg , delayed-release preparation ) as compared with placebo for nausea and vomiting of pregnancy . STUDY DESIGN A r and omized , double-blind , multicenter placebo controlled trial study ing pregnant women suffering from nausea and vomiting of pregnancy , analyzed by intention to treat . Women received Diclectin ( n = 131 ) or placebo ( n = 125 ) for 14 days . Nausea and vomiting of pregnancy symptoms were evaluated daily using the pregnancy unique quantification of emesis scale . RESULTS Diclectin use result ed in a significantly larger improvement in symptoms of nausea and vomiting of pregnancy compared with placebo based on both the pregnancy unique quantification of emesis score ( -4.8 ± 2.7 vs -3.9 ± 2.6 ; P = .006 ) and quality of life . After the trial , 64 ( 48.9 % ) women receiving Diclectin asked to continue compassionate use of their medication , as compared with 41 ( 32.8 % ) of placebo-treated women ( P = .009 ) . CONCLUSION Diclectin delayed release formulation of doxylamine succinate and pyridoxine hydrochloride is effective and well tolerated in treating nausea and vomiting of pregnancy This study assesses the effects of ginger on nausea and vomiting caused by pregnancy and compares it with metoclopramide medicine . This study was a r and omized double-blind controlled trial . Metoclopramide , Ginger and placebo were putted in similar capsules . The medicines were administered three times a day . Then the Rhodes question naire was completed and its score were calculated . Data were analyzed by Chi square test , ANOVA and Repeated measurement . The intensity of changes in nausea , vomiting and Rhodes during study were statistically different in two groups of ginger and metoclopramide compared with placebo ( p < 0.05 ) , but it was not statistically significant between two groups of ginger and metoclopramide . According to our study , ginger is less effective than metoclopramide in reducing nausea and vomiting but it could be a good alternative for metoclopramide OBJECTIVES Recent studies have concluded that acupuncture is safe in the h and s of a qualified practitioner . This study assessed the risk of adverse effects of acupuncture administered during pregnancy . METHODS 593 women with nausea and vomiting in early pregnancy volunteered to participate in a r and omised controlled trial , conducted at the Women 's and Children 's Hospital , in South Australia . Patients were given either traditional acupuncture , formula acupuncture , sham acupuncture or no acupuncture . OUTCOME MEASURES Data were collected on perinatal outcome , congenital abnormalities , pregnancy complications and the newborn . RESULTS No differences were found between study groups in the incidence of perinatal outcome , congenital abnormalities , pregnancy complications and other infant outcomes . CONCLUSION Our findings suggest that no serious adverse effects arise from acupuncture administered in early pregnancy OBJECTIVE Hyperemesis gravidarum , a severe form of nausea and vomiting due to pregnancy for which there is no proven pharmacological treatment , is the third leading cause for hospitalization during pregnancy . Corticosteroids are commonly used for the treatment of nausea and vomiting due to cancer chemotherapy – induced emesis and might prove useful in hyperemesis gravidarum . METHODS A r and omized , double-blind , placebo-controlled trial was conducted in 126 women who previously had not responded to outpatient therapy for hyperemesis gravidarum during the first half of pregnancy . Intravenous methylprednisolone ( 125 mg ) was followed by an oral prednisone taper ( 40 mg for 1 day , 20 mg for 3 days , 10 mg for 3 days , 5 mg for 7 days ) versus an identical-appearing placebo regimen . All women also received promethazine 25 mg and metoclopramide 10 mg intravenously every 6 hours for 24 hours , followed by the same regimen administered orally as needed until discharge . The primary study outcome was the number of women requiring rehospitalization for hyperemesis gravidarum . RESULTS A total of 110 women delivered at our hospital and had pregnancy outcomes available for analysis ; 56 were r and omized to corticosteroids and 54 were administered placebo . Nineteen women in each study group required rehospitalization ( 34 % versus 35 % , P = .89 , for corticosteroids versus placebo , respectively ) . CONCLUSION The addition of parenteral and oral corticosteroids to the treatment of women with hyperemesis gravidarum did not reduce the need for rehospitalization later in pregnancy Background . To determine whether low dosages of prednisolone are effective in the treatment of out patients with hyperemesis gravidarum Objective To compare the effectiveness of acupressure and vitamin B6 in the outpatient treatment of nausea and vomiting in early pregnancy . Study design Pregnant volunteers with symptoms of mild to moderate nausea and vomiting between 6 and 12 weeks ’ gestation participated in a 7-day clinical trial . Participants were r and omly assigned to receive a device for acupressure therapy and placebo drug or an otherwise identical but non-stimulating placebo device and vitamin B6 . The primary outcome measure was self-recorded symptoms according to Rhodes index . Secondary outcome measures were weight gain and medication use . Results The mean change in Rhodes index was not significantly different between the two groups . There were no statistically significant differences in weight gain and medication use between the two groups . Conclusion Acupressure therapy is not more effective than vitamin B6 in reducing nausea and vomiting in symptomatic women in the first trimester of pregnancy BACKGROUND Although the effectiveness of prednisolone therapy for severe hyperemesis gravidarum has been demonstrated , there is no consensus on how to assess severity to justify such treatment , nor any information on whether such therapy affects birth weight . AIM To document the effect of prednisolone therapy in women with defined severity of hyperemesis gravidarum . DESIGN Single centre , observational study of 30 consecutive pregnancies complicated by hyperemesis and weight loss of > 5 % of pre-pregnant weight between April 1995 and July 2000 . Comparison of birth weight with a contemporaneous control series of women admitted with hyperemesis that was judged insufficiently severe to require steroids . RESULTS Treatment with prednisolone 10 mg tid rapid resolved nausea and vomiting , allowing discharge in 3 ( range 1 - 6.5 ) days . Steroid therapy , which was reduced in a stepwise manner , was discontinued at a median gestation of 20 weeks . Maternal weight gain in pregnancy was restored to normal . Median birth weight in the severe , steroid-treated group was 3.33 ( range 2.80 - 3.27 ) kg vs. 3.27 ( range 3.04 - 3.53 ) kg in the less severe group . CONCLUSION Weight loss > 5 % served as a criterion to define a subset of women with severe hyperemesis gravidarum . In these women , steroid therapy was uniformly successful result ing in the prompt resolution of symptoms . Steroid therapy did not affect birth weight OBJECTIVE Our purpose was to investigate the efficacy of P6 acupressure in reducing or relieving symptoms of nausea with or without vomiting and retching during pregnancy . STUDY DESIGN Symptomatic pregnant volunteers ( n=161 ) participated in a 7-day community-based clinical trial . All participants were assigned to one of three groups ( i.e. , P6 acupressure , placebo [ acupressure b and s inappropriately placed ] , or control ) on the basis of a process of blocked r and omization . Data were analyzed by error bar charts and analysis of variance of difference scores . RESULTS Of 161 women , 149 ( 92.5 % ) completed the protocol . Irrespective of group assignment , participants reported significant decreases in nausea ( p<0.0009 ) and vomiting or retching ( p<0.0009 ) . However , there was no differential treatment effect as a result of acupressure . CONCLUSION There was no apparent medical benefit from the use of P6 acupressure . Our findings differ from other recently published studies that did not include a control group In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias Objective To determine the effectiveness of ginger for the treatment of nausea and vomiting of pregnancy . Methods Women with nausea and vomiting of pregnancy , who first attended an antenatal clinic at or before 17 weeks ' gestation , were invited to participate in the study . During a 5-month period , 70 eligible women gave consent and were r and omized in a double-masked design to receive either oral ginger 1 g per day or an identical placebo for 4 days . Subjects grade d the severity of their nausea using visual analog scales and recorded the number of vomiting episodes in the previous 24 hours before treatment , and again during 4 consecutive days while taking treatment . At a follow-up visit 7 days later , five-item Likert scales were used to assess the severity of their symptoms . Results All participants except three in the placebo group remained in the study . The visual analog scores of posttherapy minus baseline nausea decreased significantly in the ginger group ( 2.1 ± 1.9 ) compared with the placebo group ( 0.9 ± 2.2 , P = .014 ) . The number of vomiting episodes also decreased significantly in the ginger group ( 1.4 ± 1.3 ) compared with the placebo group ( 0.3 ± 1.1 , P < .001 ) . Likert scales showed that 28 of 32 in the ginger group had improvement in nausea symptoms compared with 10 of 35 in the placebo group ( P < .001 ) . No adverse effect of ginger on pregnancy outcome was detected . Conclusion Ginger is effective for relieving the severity of nausea and vomiting of pregnancy OBJECTIVE The aim of this study was to determine the effects of ginger in nausea and vomiting of pregnancy . DESIGN This was a single blind clinical trial study . SETTING The study was conducted in a selected prenatal care clinic of Isfahan City hospitals . SUBJECTS The subjects included 67 pregnant women who complained of nausea and vomiting from Isfahan city hospitals participated in the study . INTERVENTION The participants were r and omly assigned to two groups , an experimental group and a control group . The groups were matched according to the age , gestational age , parity , occupational status , and educational level of the participants . The experimental group received ginger 250 mg capsules for 4 days , and the control group received placebo with the same prescription form . OUTCOME MEASURES Effects of treatment of nausea were evaluated twice daily for 4 days by a before- and -
Output:
| Diclectin ® [ Duchesnay Inc. ; doxylamine succinate ( 10 mg ) plus pyridoxine hydrochloride ( 10 mg ) slow release tablet ] is more effective than placebo and ondansetron is more effective at reducing nausea than pyridoxine plus doxylamine .
Diclectin before symptoms of NVP begin for women at high risk of severe NVP recurrence reduces risk of moderate/severe NVP compared with taking Diclectin once symptoms begin .
Promethazine is as , and ondansetron is more , effective than metoclopramide for severe NVP/HG .
I.v .
fluids help correct dehydration and improve symptoms .
Dextrose saline may be more effective at reducing nausea than normal saline .
Transdermal clonidine patches may be effective for severe HG .
Enteral feeding is effective but extreme method treatment for very severe symptoms .
Day case management for moderate/severe symptoms is feasible , acceptable and as effective as inpatient care .
The economic analysis was limited by lack of effectiveness data , but comparison of costs between treatments highlights the implication s of different choices .
There was evidence of some improvement in symptoms for some treatments , but these data may not be transferable across disease severities . |
MS213108 | ***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: Nursing students ' disinterest in caring for elders presents health care challenges . As the aged population increases , nursing faculty are challenged to improve students ' attitudes toward elder care . Reed 's self-transcendence theory guided this pilot study with nursing students ( n=22 ) who implemented either a Creative-Bonding Intervention ( CBI ) or a Friendly Visit ( FV ) at senior citizen centers to test the effect of creative approaches on student self-transcendence and attitudes toward elders . Demographic data , a revised Kogan 's Attitudes toward Old People statements , and Reed 's Self-transcendence Scale were analyzed with descriptive , paired t test , ANCOVA , and Pearson correlation statistics . Results demonstrated significant differences in attitudes in the FV and changes in the expected directions in the CBI group . Self-transcendence had no significant changes . Valuable information was provided by students ' comments about the interventions . Reed 's belief that self-transcendence is present regardless of age was supported . Future studies are suggested with an increased sample size , a combined CBI/FV intervention , and supportive help during students ' intervention delivery Recent studies encourage educators in nursing to use innovative and non-traditional teaching methods , such as using popular movies , posters , portfolios and surfing the internet , to stimulate students ' interest , participation and interaction to enhance academic performance as well as knowledge retention . In this , descriptive cross-sectional study , we used self-administered question naires with statements grade d on 5-points Likert scale ( quantitative measures ) and open-ended questions ( qualitative measures ) , to assess the feasibility and students ' perceptions regarding the use of Lance Armstrong 's autobiography of surviving against cancer as a teaching tool . At the beginning of the lecture copies of selected chapters from : " It 's Not About the Bike ; My Journey Back to Life " [ Armstrong , L. , Jenkins , S. 2001 . It 's Not About The Bike : My Journey Back To Life . Yellow Jersey Press , R and om House ( Pty ) Limited , Great Britain ] , were given to students . Willing students were requested to read for the whole class while the lecturer interjected periodically to explain and expound on certain pharmacological concepts . Eighty percent ( 80 % ) of participants felt that the use of an autobiography stimulated their interesting in cancer drugs and 84 % agreed/strongly agreed that it contributed to their knowledge of pharmacology . Using Lance Armstrong 's autobiography of survival to teach cytotoxic drugs is a worthwhile and rewarding exercise from the student nurses ' perspective In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias The challenges of providing exemplary undergraduate nursing education can not be underestimated in an era when burnout and negative mood states predictably lead to alarming rates of academic as well as career attrition . While the multi-dimensional nature of this complex issue has been extensively eluci date d , few rational strategies exist to reverse a disheartening trend recognizable early in the educational process that subsequently threatens to undermine the future viability of quality healthcare . This controlled prospect i ve crossover study examined the impact of a 6-session Recreational Music-making ( RMM ) protocol on burnout and mood dimensions as well as Total Mood Disturbance ( TMD ) in first year associate level nursing students . A total of 75 first year associate degree nursing students from Allegany College of Maryl and ( ACM ) participated in a 6-session RMM protocol focusing on group support and stress reduction utilizing a specific group drumming protocol . Burnout and mood dimensions were assessed with the Maslach Burnout Inventory and the Profile of Mood States respectively . Statistically significant reductions of multiple burnout and mood dimensions as well as TMD scores were noted . Potential annual cost savings for the typical associate degree nursing program ( $ 16,800 ) and acute care hospital ( $ 322,000 ) were projected by an independent economic analysis firm . A cost-effective 6-session RMM protocol reduces burnout and mood dimensions as well as TMD in associate degree nursing students Undergraduate students often request " h and s-on " research experience but seldom have the time and opportunity during a one-semester introductory course to participate in such a project . The purpose s of this educational approach , implemented during a beginning research class for baccalaureate nursing students , were to provide an opportunity for students to participate in an experimental research study , and test the effect of a creative arts intervention on students ' stress , anxiety , and emotions . Students design ed , participated in , and analyzed the results of the project . The intervention significantly reduced stress and anxiety and increased positive emotions in this student population , while providing a creative research experience . For future use , the intervention may be helpful with a variety of vulnerable groups The effects of a creative reflective clinical experience on psychiatric nursing students ' empathy was examined using a mixed- method approach . The Interpersonal Reactivity Index ( IRI ) was used to measure empathy in students ( N = 73 ) in a baccalaureate nursing program . The control group ( n = 44 ) completed a conventional 14-week clinical experience , whereas the comparison group ( n = 29 ) experienced a community psychosocial program for 4 of the weeks . Comparison group participants completed a creative reflective assignment to represent the life experience of a client with mental illness . To further underst and empathy , a constructivist approach with purposive sampling was used to examine students ' perceptions . Four themes emerged : having expectations , building relationships , changing perceptions , and gaining underst and ing through creative expression . Trends were noted , although no statistically significant differences in IRI scores were found for either group . However , this article argues that the use of a creative reflective assignment reduces stigma and promotes empathy The purpose of this project was to examine the effect of Narrative Pedagogy in nursing education on students ' ability to move toward cognitive and ethical maturity and thereby increase their autonomy in nursing practice . Students taking a class using Narrative Pedagogy demonstrated " entry " and " exit " mean scores that showed marginal and statistically significant ( p < 0.05 ) improvement on the Measure of Intellectual Development and the California Critical Thinking Disposition Inventory . Using nonparametric and parametric analyses of variance , there was minor improvement on both scales in cognitive and ethical maturity and the disposition to think critically in the intervention group . For all variables , there were no significant differences between the control group and the intervention group , with or without adjustment for age , the only significant covariate . The cognitive and ethical growth documented by either instrument is probably not large enough to be considered practically significant in terms of movement toward autonomous practice This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence The aim of the study was to develop an educational tool consisting of selection s of paintings in order to complement theoretical knowledge regarding non-verbal communication . Another aim was to investigate students ' opinions of the educational tool . A visual art programme which introduced student nurses to varying facial expressions in art reproductions was developed as a complement to textbooks on nonverbal communication . Participants were student nurses from two nursing schools in Sweden . Data were collected over a period of two years ( 1998 - 2000 ) in the second year of the 3-year undergraduate programme . Participants were able to infer whether a positive or negative message had been given to the depicted person . Participants ' evaluations of the programme were expressed in positive terms In an effort to bridge the gap in learning in the affective domain , nurse educators must underst and and develop meaningful teaching strategies . Specific strategies design ed to facilitate cognitive underst and ing of the affective response can be found in entertainment films . The findings of this study suggest that the use of entertainment films with guidance is effective in teaching empathetic responses . The continued study of the complex phenomenon in developing an underst and ing of the many variables that comprise not only the experience of empathy , but also the transference of the experience into helping interventions A r and omized study was performed to investigate whether a teaching intervention program using a reproduction of Edvard Munch 's painting , " The Sick Girl , " stimulated student nurses to engage in learning about empathy . A control group was used to control for effects of the visual art dialogues in the intervention group . The study was undertaken at a university college of health science in Sweden . Data were collected from student nurses ( n = 144 ) during their first study year . The result showed a significant improvement in the visual art group compared with the matched control group . Students in the visual art group were more engaged in learning about empathy when measured with the Wheel Question naire parameters of structure , motivation , and emotional investment . The present study supported the idea that Edvard Munch 's painting could be used in nurse education complementary to theoretical knowledge on empathy to stimulate student nurses to engage in empathy learning Visual art dialogues were used in student nurses ' education as a teaching and learning complement to theoretical knowledge of nursing care . An intervention group as well as a control group discussed what was characteristic of good nursing care . The control group was used to control for the effects of visual art dialogues in the intervention group . The study was undertaken at two university colleges of health sciences in Sweden . Data were collected from student nurses ( n = 267 ) during their first year of study . The Wheel Question naire was used in the intervention group and control group . It measured three aspects of student nurses ' perception of nursing situations : structure , the extent of emotional involvement , and motivation . The results showed statistical differences ( one way ANOVA ) between the intervention group in which visual art dialogues were implemented and the control group . Students in the intervention group , compared to the control group , were more structured , motivated and emotionally balanced when they expressed the elements most typical of good nursing care . They showed personal readiness in caring situations
Output:
| The two synthesized findings revealed that art forms could create meaning and inspire learning in undergraduate nursing education and that ABP can develop important learner outcomes /competencies for professional nursing .
The narrative synthesis suggested that ABP improved nursing students ' knowledge acquisition , level of empathy , attitude toward others , emotional states , level of reflective practice , learning behaviors and aspects of cognitive/ethical maturity .
When the QL and QN findings were interpreted as a whole , ABP appeared to facilitate learning in the cognitive and affective domains and may be especially useful in addressing the affective domain .
Nurse educators should consider using ABP as students found that this approach offered a meaningful way of learning and result ed in the development of important competencies for professional nursing .
The QN studies provide a very low level of evidence that ABP improved students ' knowledge acquisition , level of empathy , attitude toward others , emotional states , level of reflective practice , learning behaviors and aspects of cognitive/ethical maturity .
Although the QN findings can inform future research , the evidence is not robust enough to demonstrate improved outcomes |
MS213109 | ***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 : Allergen-specific immunotherapy ( SIT ) is a highly effective treatment for allergic diseases , but the underlying mechanisms are unclear . In this study , we investigated the effects of cluster SIT with Dermatophagoides pteronyssinus ( Der p ) on IL-10-secreting type I T regulatory ( Tr1 ) cells in Der p-sensitized patients with allergic rhinitis . Methods : This was a prospect i ve r and omized study involving 68 participants ( aged 18–60 years ) of whom 38 were patients with allergic rhinitis and received Der p-SIT for 1 year and 30 were nonallergic controls . IL-10+IL-4–CD4 + T cells were measured by flow cytometry for the patient group at baseline and at the end of 1 year of SIT , and for nonallergic controls . Similarly , IL-10 in supernatants from allergen-stimulated peripheral blood mononuclear cell ( P BMC ) cultures were measured by ELISA , and the suppressive effect of Tr1 cells on cell proliferation and cytokine release ( IFN-γ and IL-4 ) in P BMC s was estimated in cultures from both groups . Allergen-specific serum IgE and IgG4 were also assessed by RAST and ELISA for the SIT group . Results : The levels of IL-10-secreting Tr1 cells , IgG4 and allergen-induced IL-10 synthesis from P BMC cultures were significantly increased and the function of Tr1 cells was enhanced after 1 year of SIT compared to baseline levels . In contrast , the level of IgE was not significantly changed . Conclusion : These data suggest that the cluster Der p-SIT may enhance the frequency and function of IL-10-secreting Tr1 cells BACKGROUND Data on the long-term effects of sublingual immunotherapy ( SLIT ) are sparse , and the optimal duration of treatment is a matter of debate . OBJECTIVE We sought to prospect ively evaluate the long-term effect of SLIT given for 3 , 4 , or 5 years and to compare the effect of those different duration s. METHODS In this prospect i ve open controlled study we followed up patients with respiratory allergy who were monosensitized to mites for 15 years . The subjects were divided in 4 groups receiving drug therapy alone or SLIT for 3 , 4 , or 5 years . Clinical scores , skin sensitizations , methacholine reactivity , and nasal eosinophil counts were evaluated every year during the winter months . The clinical effect was considered to persist until clinical scores remained at less than 50 % of the baseline value , and then patients underwent another course of SLIT . RESULTS Seventy-eight patients were enrolled , and 59 completed the study . In the 12 control subjects no relevant change in clinical scores was seen throughout the study . In the patients receiving SLIT for 3 years , the clinical benefit persisted for 7 years . In those receiving immunotherapy for 4 or 5 years , the clinical benefit persisted for 8 years . New sensitizations occurred in all the control subjects over 15 years and in less than a quarter of the patients receiving SLIT ( 21 % , 12 % , and 11 % , respectively ) . The second course of vaccination induced a benefit more rapidly than the first course . The behavior of bronchial hyperreactivity and nasal eosinophils paralleled the clinical score . CONCLUSION Under the present conditions , it can be suggested that a 4-year duration of SLIT is the optimal choice because it induces a long-lasting clinical improvement similar to that seen with a 5-year course and greater than that of a 3-year vaccination BACKGROUND Subcutaneous allergen-specific immunotherapy ( SIT ) has an early onset of action , whereas repeated injections and safety concerns have limited its use in the pediatric age group . Meanwhile , the improved safety profile of the sublingual route has been accepted as an alternative despite its relatively late onset of action . OBJECTIVE We sought to improve the efficacy and safety of SIT with a combination of the subcutaneous route in the build-up phase and sublingual maintenance in comparison with the sublingual or subcutaneous routes alone . METHODS Fifty-one house dust mite-sensitized children with mild-to-moderate asthma were r and omized into one of 4 groups to receive either ( 1 ) subcutaneous immunotherapy ( SCIT ) , ( 2 ) sublingual immunotherapy ( SLIT ) , ( 3 ) SCIT plus SLIT , or ( 4 ) pharmacotherapy . Clinical parameters were evaluated at baseline and months 1 , 4 , 12 , and 18 . Allergen-specific immunoglobulin levels and allergen-induced IL-5 , IL-10 , IL-13 , IL-17 , TGF-β , and IFN-γ levels were evaluated as well . RESULTS In the SCIT and SCIT plus SLIT groups , the number of asthma attacks and inhaled corticosteroid dosage decreased compared with baseline values at the months 4 , 12 , and 18 but only at month 12 in the SLIT group . The improvement in visual analog scores for rhinitis was significant only in the SCIT plus SLIT group . Increases in the levels of regulatory and T(H)1 cytokines were observed both in the SCIT and SLIT groups , with some differences in dynamics . Antigen-specific IgG(4 ) levels increased in the SCIT and SCIT plus SLIT groups but not in the SLIT group . Clinical symptom scores were correlated positively with IL-5 levels and negatively with antigen-specific IgG(4 ) , IFN-γ , and TGF-β levels . CONCLUSION Our novel regimen of immunotherapy , SCIT plus SLIT , appeared promising in that it successfully combined the advantages of the 2 alternatives : rapid onset and potency in SCIT and safety and avoidance of injections in SLIT BACKGROUND Icatibant , a bradykinin B(2 ) receptor antagonist , inhibits the reduction in nasal patency after challenge with house dust mite antigen in sensitive subjects and abolishes the nasal hyperresponsiveness induced by platelet-activating factor in nonatopic subjects . OBJECTIVE We sought to investigate the effect of icatibant on the response to nasal antigen challenge in subjects with seasonal allergic rhinitis . METHODS Patients allergic to grass pollen antigen ( n = 9 - 13 ) were included in a double-blind , r and omized-block , placebo-controlled , crossover study outside the pollen season . Subjects first received an intranasal spray of icatibant ( 200 microg per nostril ) or a saline control . Subjects were then challenged with antigen or diluent ( control ) , and their responses were monitored by using acoustic rhinometry . Six hours later , nasal lavage fluid was collected and quantified for inflammatory cells and various inflammatory mediators ( kinin , eosinophil cationic protein , IL-5 , and IL-8 ) . At 24 hours , the response of the nasal airways to 200 microg of histamine was assessed , and a further nasal lavage was carried out . RESULTS Antigen challenge caused a significant increase in nasal obstruction and albumin extravasation , which was not affected by icatibant . Nasal hyperresponsiveness to histamine was present 24 hours after antigen and was abolished by pretreatment with icatibant . Icatibant also reduced the antigen-induced increase in eosinophils , eosinophil cationic protein , kinin , and IL-8 in nasal lavage fluid . CONCLUSION Pretreatment with icatibant does not affect the acute inflammatory response in seasonal allergic rhinitis . However , our results imply the involvement of kinins and the bradykinin B(2 ) receptor in the development of antigen-induced hyperresponsiveness and the associated eosinophilia in the human nasal airway Live Lactobacillus paracasi 33 ( LP33 ) may effectively improve the quality of life for patients with perennial allergic rhinitis . It has been demonstrated that heat-killed lactic acid bacteria ( LAB ) suppress specific immunoglobulin E synthesis and stimulate interleukin-12 production in animals . The aim of this study was , therefore , to evaluate the efficacy of heat-killed LP33 in the treatment of allergic rhinitis induced by house-dust-mite in human subjects . A total of 90 patients were enrolled in a r and omized , double blind , placebo-controlled trial and assigned to three treatment groups . Patients in groups A and B received two capsules per day of live or heat-killed LAB ( 5 x 10(9 ) colony-forming units/capsule ) , respectively , over a period of 30 days while those in Group C received placebo capsules . A modified question naire on pediatric rhinoconjunctivitis-related quality of life was administered to all subjects or their parents during each clinical visit . The overall quality of life score decreased for groups A and B , as compared with the placebo group , in terms of both frequency ( 9.47 + /- 2.89 , 6.30 + /- 2.19 , vs. -3.47 + /- 1.53 , respectively ; p < 0.0001 ) and level of bother ( 5.91 + /- 3.21 , 6.04 + /- 2.44 , vs. -2.80 + /- 1.64 , respectively ; p = 0.004 ) after the 30-day treatment . The efficacy of the heat-killed LP33 was not inferior to the live variant . No obvious side effects were reported for either active treatment group during the study period . Our results suggest that heat-killed LP33 can effectively improve the overall quality of life for patients with allergic rhinitis , and that it may be efficacious as an alternative treatment BACKGROUND House dust mite ( HDM ) allergy is associated with persistent allergic rhinitis ( AR ) and allergic asthma . OBJECTIVE To investigate the efficacy and safety of a SQ HDM sublingually administered immunotherapy tablet ( ALK , Hørsholm , Denmark ) in adults and adolescents with HDM respiratory allergic disease and report the AR results . METHODS Six hundred four subjects at least 14 years old with HDM AR and mild to moderate HDM allergic asthma were r and omized 1:1:1:1 to double-blinded daily treatment with 1 , 3 , 6 SQ-HDM or placebo . End-of-treatment rhinoconjunctivitis symptoms and medication score were predefined extrapulmonary end points . A subgroup analysis was conducted post hoc in subjects with a total combined rhinitis score ( TCRS ) > 0 ( ie , with AR symptoms and /or AR medication use during the 4-week baseline period ) . The subgroup was comprised of 498 subjects ( 82 % ) . RESULTS In the subgroup , the absolute difference in end-of-treatment TCRS between 6 SQ-HDM and placebo was -0.78 ( 95 % confidence interval -1.47 to -0.07 , relative difference 28.8 % , P = .0357 ) . Furthermore , a significant difference was found for the total score of the Rhinitis Quality of Life Question naire with St and ardized Activities RQLQ(S ) and for the individual domains : activities , sleep , non-nose and non-eye symptoms , and nasal symptoms . For the TCRS and Rhinitis Quality of Life Question naire score , a dose response was seen , with numerically lower , nonsignificant differences for 1 and 3 SQ-HDM . The predefined analysis for the entire trial population showed no statistically significant difference between the placebo and actively treated groups . No safety concerns were observed . CONCLUSION Efficacy in mild to severe AR of 6 SQ-HDM compared with placebo was demonstrated by statistically significant improvements in TCRS and Rhinitis Quality of Life Question naire score in subjects with AR present at baseline . The treatment was well tolerated . TRIAL REGISTRATION EudraCT , no 2006 - 001795 - 20 ; Clinical Trials.gov , identifier NCT00389363 BACKGROUND Both SCIT ( subcutaneous immunotherapy ) and SLIT ( sublingual immunotherapy ) have clinical and immunologic efficacy in children with rhinitis and asthma but comparative studies are scarce . OBJECTIVE To investigate the clinical and immunological efficacy of mite-specific SLIT and SCIT in children with rhinitis and asthma . METHOD Thirty children monosensitized to house dust mite were r and omized to receive either active SCIT or SLIT or placebo for 1 yr in a double-blind double-dummy placebo controlled design ( Yukselen A et al. , Int Arch Allergy Immunol 2012 ; 157:288 - 298 ) . Thereafter , the placebo group was r and omized to receive SCIT or SLIT , and for 1 yr all patients received active treatment with SCIT or SLIT . Symptom scores , drug usage , titrated skin prick tests , nasal and bronchial allergen provocation doses , serum house dust mite-specific immunglobulin E , sIgG4 , IL-10 and IFN- g levels were evaluated . RESULTS The reduction of clinical scores with SLIT was more evident after 2 years of treatment in comparison to both the baseline and DBPC phase of the study . The change in titrated skin prick tests and nasal provocative doses was more prominent with both SCIT and SLIT at the end of the open phase . Although the increase inbronchial provocative doses was not significant at the end of the first year of treatment with SLIT , it reached a statistically significant difference after two years of treatment . CONCLUSION The clinical efficacy of SLIT is more prominent at the end of the second year , although this improvement is
Output:
| Conclusions : SLIT tablets effectively relieve rhinitis symptoms in adults with allergic rhinitis . |
MS213110 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND AND AIM While lispro insulin has been reported to lower postpr and ial blood glucose concentrations , less consistent effects have been shown for glycosylated hemoglobin ( HbA1c ) levels . Aim of this study was to determine whether pre-meal association of NPH , an intermediate-acting insulin , with lispro improves overall glycemic control in type 1 diabetic patients . METHODS AND RESULTS Eighty-five type 1 diabetic patients were studied in a multicenter r and omized comparative ( human regular vs lispro insulin ) crossover ( 3-month ) study in which NPH insulin was given as a dinner or bedtime injection and at breakfast and lunch if necessary . The number of injections was kept constant : 42 % and 58 % of patients injected insulin 3 and 4 times per day , respectively . Fasting and prepr and ial blood glucose levels were similar , while postpr and ial levels improved after lispro compared to human regular insulin ( breakfast : 8.28 + /- 2.39 vs 9.28 + /- 2.72 mmol/l ; lunch : 8.33 + /- 2.67 vs 9.06 + /- 2.67 mmol/l , dinner : 8.06 + /- 2.72 vs 9.28 + /- 2.44 mmol/l , ANOVA : p = 0.003 ) . HbA1c also improved after lispro : 8.1 + /- 0.9 vs 8.3 + /- 0.8 % , p < 0.05 . The rate of hypoglycemia was similar . Patients showed better acceptance of lispro treatment ( p < 0.001 ) . CONCLUSIONS Lispro improves overall blood glucose control in type 1 diabetic patients without increasing the incidence of hypoglycemia . This can be achieved by an optimal combination of lispro insulin with NPH whenever the time intervals between meals are too long BACKGROUND Although insulin lispro ( insulin LP ) has been shown to improve postpr and ial blood glucose ( BG ) control and reduce hypoglycemic episodes in adult patients with type I diabetes , there appear to have been few clinical studies focusing on its use in adolescents . OBJECTIVE This study compared the effects of insulin LP with those of regular human insulin ( insulin R ) on postpr and ial BG control and hypoglycemia in adolescents with type diabetes . METHODS In this crossover , open-label study , adolescents between the ages of 9 and 18 years who had reached Tanner stage II puberty were r and omized to receive either insulin LP immediately before meals or insulin R 30 to 45 minutes before meals , in addition to daily intermediate-acting insulin . After 4 months , patients were switched to the alternate treatment sequence . Eight-point BG profiles , hypoglycemia rate , and glycosylated hemoglobin ( HbA1c ) were measured at baseline and end point . RESULTS Four hundred eighty-one adolescents participated in the study at 53 investigative sites in 15 countries ; 463 were r and omized to treatment ( 228 insulin LP , 235 insulin R ) , and 457 completed the study . Insulin LP given before breakfast result ed in significantly lower mean ( + /-SD ) 2-hour postpr and ial BG levels compared with insulin R ( 9.7 + /- 4.0 mmol/L vs 10.6 + /- 4.3 mmol/L , respectively ; P < 0.001 ) . Insulin LP given before dinner result ed in significantly lower 2-hour postpr and ial BG levels compared with insulin R ( 8.6 + /- 3.5 mmol/L vs 9.3 + /- 3.7 mmol/L ; P = 0.003 ) . No differences were seen between treatments in 2-hour postpr and ial BG levels after the midday meal . Mean baseline HbA1c values were similar between sequence groups , and no between-group difference in HbA1c was observed at end point ( insulin LP , 8.69 % + /- 1.52 % ; insulin R , 8.70 % + /- 1.65 % ) . Treatment with insulin LP result ed in a significantly lower incidence of hypoglycemic episodes per patient per 30 days compared with insulin R ( 4.02 + /- 4.5 vs 4.37 + /- 4.5 , respectively ; P = 0.023 ) and significantly fewer hypoglycemic episodes between midnight and 6 AM ( 1.0 + /- 1.9 vs 1.7 + /- 2.6 ; P < 0.001 ) . CONCLUSIONS In adolescents with type 1 diabetes , insulin LP significantly improved postpr and ial glycemic control and reduced episodes of nocturnal hypoglycemia compared with insulin R. Insulin LP was well tolerated and effective as part of an intensified insulin regimen in this study population Lispro ( LP ) and regular human ( HR ) insulins were compared in Type 1 diabetic ( T1DM ) patients on either a Mediterranean diet or normal diet . Twelve T1DM patients were recruited and r and omized into two groups of 6 , groups A and B. They were treated in different sequences ( in 3-month intervals for 1 year ) . Group A : LP insulin and normal diet , LP insulin and Mediterranean diet , regular insulin and Mediterranean diet , regular insulin and normal diet . Group B : regular insulin and normal diet , regular insulin and Mediterranean diet , LP insulin and Mediterranean diet , LP insulin and normal diet . Each patient was treated with rapid acting insulin , either LP insulin or HR insulin , before each main meal and a dose of slow acting insulin at bedtime . Every 15 days the glycemic control , the incidence and frequency of hypoglycemic episodes , and any adverse events were evaluated . Every 3 months , hematology and a chemistry panel , pre- and post-pr and ial glycemic and insulinemic profiles were evaluated in all patients . HbA1c levels significantly decreased in LP patients on normal diet , post-pr and ial glycemic levels were significantly lower in LP than in HR patients from 30 min onwards , 15-min post-pr and ial insulin levels higher in LP- than in HR-treated patients , and hypoglycemic episodes were significantly less in LP- than in HR-treated patients . LP insulin , irrespective of the type of diet , results in more effective glycemic control , significantly reduces hypoglycemic episodes as opposed to traditional insulin therapy and seems to be more effective with a normal diet than with a Mediterranean diet The absorption of regular human insulin from subcutaneous injection sites is delayed due to the self-association of insulin to multimeric forms . The insulin analogue insulin lispro has a weak self-association and a fast absorption rate . We examined the safety and efficacy of insulin lispro in the premeal treatment of patients with diabetes mellitus . A 12-month study was performed in 336 patients with insulin-dependent diabetes mellitus ( IDDM ) and 295 patients with non-insulin-dependent diabetes mellitus ( NIDDM ) . The patients were r and omized to inject either regular human insulin 30 to 45 minutes before eating , or insulin lispro immediately before each meal , in addition to basal insulin . The postpr and ial rise in serum glucose was lower in patients receiving insulin lispro than in those receiving regular human insulin therapy . At end point the increment was significantly lower at 1 hour ( 35 % ) and at 2 hours ( 64 % ) after the meal in IDDM patients ; in NIDDM patients , the increment was nonsignificantly lower at 1 hour ( 19 % ) and significantly lower at 2 hours ( 48 % ) . IDDM patients receiving insulin lispro achieved significantly lower glycated hemoglobin ( HbA1c ) levels in patients receiving regular human insulin ( 8.1 % vs 8.3 % ) . In NIDDM patients , HbA1c levels decreased equally in both treatment groups . Due to its fast absorption rate , insulin lispro improves postpr and ial control in diabetes . Insulin lispro can be considered one step toward optimal insulin therapy and improved patient convenience Summary Recombinant DNA technology allows the production of insulin analogues with faster absorption rates from subcutaneous tissue as compared to soluble human insulin . The human insulin analogue B10Asp ( mono/dimeric ) is absorbed twice as fast as soluble human insulin ( hexameric ) . A double blind , r and omised crossover study with a 1-month run-in period and two 2-month treatment periods was performed in 21 male insulin-dependent diabetic ( IDDM ) patients aged 18–40 years in order to compare the metabolic control obtained with equimolar doses of the analogue B10Asp vs soluble human insulin ( Actrapid ) given as mealtime insulin and intermediate acting isophane insulin ( Protaphane ) at bedtime . At the end of each 2-month study period , the patients were admitted to the metabolic ward . We found significantly higher plasma insulin/analogue levels after breakfast , lunch and dinner with B10Asp as compared to Actrapid ( p<0.05 ) . The plasma insulin/analogue levels were significantly lower before lunch and dinner with B10Asp as compared to Actrapid ( p<0.05 ) . Also , the plasma insulin/analogue level tended to be lower at bedtime when comparing B10Asp to Actrapid . The 24-h blood glucose profiles showed identical fasting blood glucose , significantly lower blood glucose after breakfast with the analogue ( p<0.05 ) , no differences in blood glucose after lunch and dinner but a significantly higher blood glucose at midnight using the analogue ( p<0.05 ) . The overall 24-h mean blood glucose concentrations , the daily insulin dose , HbA1c , diet , home blood glucose monitoring and frequency of hypoglycaemia were almost identical in the two treatment periods . In conclusion , the overall glycaemic control remained unchanged and quite good when Actrapid was exchanged dose for dose with the insulin analogue B10Asp in IDDM patients treated with a basal bolus regime IMPORTANCE Type 1 diabetes has historically been associated with a significant reduction in life expectancy . Major advances in treatment of type 1 diabetes have occurred in the past 3 decades . Contemporary estimates of the effect of type 1 diabetes on life expectancy are needed . OBJECTIVE To examine current life expectancy in people with and without type 1 diabetes in Scotl and . We also examined whether any loss of life expectancy in patients with type 1 diabetes is confined to those who develop kidney disease . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort of all individuals alive in Scotl and with type 1 diabetes who were aged 20 years or older from 2008 through 2010 and were in a nationwide register ( n=24,691 contributing 67,712 person-years and 1043 deaths ) . MAIN OUTCOMES AND MEASURES Differences in life expectancy between those with and those without type 1 diabetes and the percentage of the difference due to various causes . RESULTS Life expectancy at an attained age of 20 years was an additional 46.2 years among men with type 1 diabetes and 57.3 years among men without it , an estimated loss in life expectancy with diabetes of 11.1 years ( 95 % CI , 10.1 - 12.1 ) . Life expectancy from age 20 years was an additional 48.1 years among women with type 1 diabetes and 61.0 years among women without it , an estimated loss with diabetes of 12.9 years ( 95 % CI , 11.7 - 14.1 ) . Even among those with type 1 diabetes with an estimated glomerular filtration rate of 90 mL/min/1.73 m2 or higher , life expectancy was reduced ( 49.0 years in men , 53.1 years in women ) giving an estimated loss from age 20 years of 8.3 years ( 95 % CI , 6.5 - 10.1 ) for men and 7.9 years ( 95 % CI , 5.5 - 10.3 ) for women . Overall , the largest percentage of the estimated loss in life expectancy was related to ischemic heart disease ( 36 % in men , 31 % in women ) but death from diabetic coma or ketoacidosis was associated with the largest percentage of the estimated loss occurring before age 50 years ( 29.4 % in men , 21.7 % in women ) . CONCLUSIONS AND RELEVANCE Estimated life expectancy for patients with type 1 diabetes in Scotl and based on data from 2008 through 2010 indicated an estimated loss of life expectancy at age 20 years of approximately 11 years for men and 13 years for women compared with the general population without type 1 diabetes AIMS Despite considerable experience with insulin lispro , few blinded comparisons with soluble insulin are available . This study compared insulin lispro with human soluble insulin in patients with Type 1 diabetes m
Output:
| Conclusions Short-acting insulin analogues are superior to regular human insulin in T1DM patients for the following outcomes : total hypoglycemic episodes , nocturnal hypoglycemia , severe hypoglycemia , postpr and ial glucose , and HbA1c |
MS213111 | ***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 test whether adding mobile application coaching and patient/provider web portals to community primary care compared with st and ard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A cluster-r and omized clinical trial , the Mobile Diabetes Intervention Study , r and omly assigned 26 primary care practice s to one of three stepped treatment groups or a control group ( usual care ) . A total of 163 patients were enrolled and included in analysis . The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period . Secondary outcomes were changes in patient-reported diabetes symptoms , diabetes distress , depression , and other clinical ( blood pressure ) and laboratory ( lipid ) values . Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support . Patients received automated , real-time educational and behavioral messaging in response to individually analyzed blood glucose values , diabetes medications , and lifestyle behaviors communicated by mobile phone . Providers received quarterly reports summarizing patient ’s glycemic control , diabetes medication management , lifestyle behaviors , and evidence -based treatment options . RESULTS The mean declines in glycated hemoglobin were 1.9 % in the maximal treatment group and 0.7 % in the usual care group , a difference of 1.2 % ( P = 0.001 ) over 12 months . Appreciable differences were not observed between groups for patient-reported diabetes distress , depression , diabetes symptoms , or blood pressure and lipid levels ( all P > 0.05 ) . CONCLUSIONS The combination of behavioral mobile coaching with blood glucose data , lifestyle behaviors , and patient self-management data individually analyzed and presented with evidence -based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year OBJECTIVE —The purpose of this study was to determine whether implementation of a multicomponent organizational intervention can produce significant change in diabetes care and outcomes in community primary care practice s. RESEARCH DESIGN AND METHODS —This was a group-r and omized , controlled clinical trial evaluating the practical effectiveness of a multicomponent intervention ( TRANSLATE ) in 24 practice s. The intervention included implementation of an electronic diabetes registry , visit reminders , and patient-specific physician alerts . A site coordinator facilitated previsit planning and a monthly review of performance with a local physician champion . The principle outcomes were the percentage of patients achieving target values for the composite of systolic blood pressure ( SBP ) < 130 mmHg , LDL cholesterol < 100 mg/dl , and A1C < 7.0 % at baseline and 12 months . Six process measures were also followed . RESULTS —Over 24 months , 69,965 visits from 8,405 adult patients with type 2 diabetes were recorded from 238 health care providers in 24 practice s from 17 health systems . Diabetes process measures increased significantly more in intervention than in control practice s , giving net increases as follows : foot examinations 35.0 % ( P < 0.0.001 ) ; annual eye examinations 25.9 % ( P < 0.001 ) ; renal testing 28.5 % ( P < 0.001 ) ; A1C testing 8.1%(P < 0.001 ) ; blood pressure monitoring 3.5 % ( P = 0.05 ) ; and LDL testing 8.6 % ( P < 0.001 ) . Mean A1C adjusted for age , sex , and comorbidity decreased significantly in intervention practice s ( P < 0.02 ) . At 12 months , intervention practice s had significantly greater improvement in achieving recommended clinical values for SBP , A1C , and LDL than control clinics ( P = 0.002 ) . CONCLUSIONS — Introduction of a multicomponent organizational intervention in the primary care setting significantly increases the percentage of type 2 diabetic patients achieving recommended clinical outcomes BACKGROUND Our objective was to test the effect of physicians providing brief health lifestyle counseling to patients with type 2 diabetes mellitus during usual care visits . METHODS We conducted a r and omized controlled trial of a 12-month intervention at 2 large community health centers , enrolling 310 patients with a body mass index ( calculated as weight in kilograms divided by height in meters squared ) of 25 or greater . In the intervention group , self-management goals for nutrition and physical activity were set using a tailored computer program . Goals were then review ed at each clinic visit by physicians . The control group received only printed health education material s. The main outcome measures included change in physical activity and body weight . RESULTS In the intervention group , recommended levels of physical activity increased from 26 % at baseline to 53 % at 12 months ( P < .001 ) compared with controls ( 30 % to 37 % ; P= .27 ) , and 32 % of patients in the intervention group lost 6 or more pounds at 12 months compared with 18.9 % of controls ( odds ratio , 2.2 ; P= .006 ) . CONCLUSION A brief intervention to increase the dialogue between patients and health care providers about behavioral goals can lead to increased physical activity and weight loss Purpose : Physicians and patients frequently miss opportunities to improve the quality of care of diabetes , primarily because of the complexity of managing many risk factors over many years with many other providers . Electronic decision support is a potential way to improve prescribing and quality of care . Shared care , meaning patients and physicians sharing access to the patient ’s status compared to recommended targets , is thought to improve outcomes as are supportive reminders . Our objective was to rigorously evaluate whether an electronic medical record (EMR)-linked , individualized electronic diabetes tracker with automated telephone reminders could improve the quality of diabetes management in primary care . Methods : Community-based family physicians across Ontario who were already using EMRs in their practice , were recruited . Patient and physician versions of a Web-based diabetes tracker , the ( COMPETE II Diabetes Tracker ( CIIDT ) system , were developed . The main tracker page showed all 13 monitoring variables – the patient ’s recent values , both process ( when last checked ) and outcome ( the result ) , target values for process and outcome , and short advisory messages , with red/yellow/green highlighting to indicate urgency of review . Links to best evidence guidelines and patient re sources were provided . The physician view appeared as an overlay in a corner of their own electronic medical record ( N = 6 EMR products ) . Intervention patients were linked to a voice biometric-enabled automated telephone reminder system ( ATRS ) for medications , labs and visits . Consenting patients with diabetes were r and omized to the CIIDT-ATRS intervention or usual care ( neither ) . Since the study was relatively short ( 6 months follow-up ) , the primary outcome was a composite score of process quality – the quality of monitoring the variables compared to target . Secondary outcomes included clinical outcomes plus evaluations of the tracker and ATRS , and impact on health information privacy . Results : Forty-eight physicians ( mean age ( SD ) = 45.2 ( 10.0 ) , 38.2 % female ) were recruited and 511 patients ( mean age ( SD ) = 60.3 ( 12.4 ) , 49.6 % female , 78 % completed high school ) were r and omized . Only 46.1 % of patients used the Internet at least monthly so print versions of their recent information were sent to them prior to their physician visits . There were frequent technical problems with the Web-based tracker and a lack of data integration between the various EMRs and the tracker . Despite problems , the primary outcome of composite score of physician visits , and checks of blood pressure ( BP ) , LDL cholesterol , HbA1C , microalbuminuria , BMI , feet and eyes , showed a highly statistically significant improvement in the intervention group compared to control ( p<0.0001 ) . There were also highly statistically significant improvements in actual blood pressure ( -2.68 mm diastolic BP , p=0.007 ) and in HbA1C ( -.2 % , p=0.001 ) . 75.9 % of intervention patients were as satisfied or more satisfied with their care since the use of the tracker system and 62.5 % voted to continue to receive ATRS reminders . 22.4 % of patients felt that , in general , the risk of possible loss of confidentiality outweighed the benefits that computers could bring to their health . Over the course of the study , physicians developed a more favourable attitude towards the benefits vs risks of computerized systems in healthcare . Discussion : Despite considerable technical challenges for both patients and physicians , we have demonstrated that the care of a complex chronic disease can be improved with electronic tracking and decision support for both physician and patient . This is one of the first r and omized trial to demonstrate success in routine , community-based primary care . Funding Source : Grant from the Canada Health Infostructure Partnerships Program , Health Canada . References : 1 . Branger PJ . van't Hooft A. van der Wouden JC . Moorman PW . van Bemmel JH . Shared care for diabetes : supporting communication between primary and secondary care . International Journal of Medical Informatics 1999 ; 53:133 - 42 . 2 . Jerant AF . Hill DB . Does the use of electronic medical records improve surrogate patient outcomes in outpatient setting s ? Journal of Family Practice 2000;49:349 - 57 . * Dr Lee is deceased BACKGROUND Optimal care for patients with diabetes is difficult to achieve in clinical practice . OBJECTIVE To evaluate the impact of a registry and decision support system on processes of care , and physiologic control . PARTICIPANTS R and omized trial with clustering at the practice level , involving 7,412 adults with diabetes in 64 primary care practice s in the Northeast . INTERVENTIONS Provider decision support ( reminders for overdue diabetes tests , alerts regarding abnormal results , and quarterly population reports with peer comparisons ) and patient decision support ( reminders and alerts ) . MEASUREMENTS AND MAIN RESULTS Process and physiologic outcomes were evaluated in all subjects . Functional status was evaluated in a r and om patient sample via question naire . We used multiple logistic regression to quantify the effect , adjusting for clustering and potential confounders . Intervention subjects were significantly more likely to receive guideline -appropriate testing for cholesterol ( OR = 1.39 ; [ 95%CI 1.07 , 1.80 ] P = 0.012 ) , creatinine ( OR = 1.40 ; [ 95%CI 1.06 , 1.84 ] P = 0.018 ) , and proteinuria ( OR = 1.74 ; [ 95%CI 1.13 , 1.69 ] P = 0.012 ) , but not A1C ( OR = 1.17 ; [ 95 % CI 0.80 , 1.72 ] P = 0.43 ) . Rates of control of A1C and LDL cholesterol were similar in the two groups . There were no differences in blood pressure , body mass index , or functional status . CONCLUSIONS A chronic disease registry and decision support system based on easily obtainable laboratory data was feasible and acceptable to patients and providers . This system improved the process of laboratory monitoring in primary care , but not physiologic control OBJECTIVE —The Diabetes Care Protocol combines task delegation ( a practice nurse ) , computerized decision support , and feedback every 3 months . We studied the effect of the Diabetes Care Protocol on A1C and cardiovascular risk factors in type 2 diabetic patients in primary care . RESEARCH DESIGN AND METHODS —In a cluster r and omized trial , mean changes in cardiovascular risk factors between the intervention and control groups after 1 year were calculated by generalized linear models . RESULTS —Throughout the Netherl and s , 26 intervention practice s included 1,699 patients and 29 control practice s 1,692 patients . The difference in A1C change was not significant , whereas total cholesterol , LDL cholesterol , and blood pressure improved significantly more in the intervention group . The 10-year coronary heart disease risk estimate of the UK Prospect i ve Diabetes Study improved 1.4 % more in the intervention group . CONCLUSIONS —Delegation of routine diabetes care to a practice nurse combined with computerized decision support and feedback did not improve A1C but reduced cardiovascular risk in type 2 diabetes patients OBJECTIVE To evaluate whether an electronic reminder integrated into a routine computer system increases the use of antiplatelet drugs for diabetic patients among Italian general practitioners ( GPs ) . RESEARCH DESIGN AND METHODS A r and omized controlled trial was carried out among 300 GPs and their patients selected from the Health Search Data base . Among these , 150 GPs ( intervention group ) received instructions to activate an electronic reminder plus a letter summarizing the beneficial effects of antiplatelet drugs in diabetic patients with at least one additional cardiovascular risk factor ( " high risk " ) , whereas the other 150 GPs ( control group ) received only the letter . The electronic reminder , integrated into a st and ard software system for the management of the daily clinical practice , was displayed when every participating GP opened the medical record of diabetic patients aged > or = 30 years . Only high-risk diabetic patients were included in the analysis . Patients were considered under antiplatelet treatment if they received two or more prescriptions at baseline and during the follow-up . RESULTS We selected 15,343 high-risk diabetic patients , 7,313 belonging to GPs of the control group and 8,030 belonging to GPs of the intervention group . Overall , 1,
Output:
| Triglycerides and practitioner performance tended to favour computerized clinical decision support systems although results were too heterogeneous to pool . |
MS213112 | ***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 Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review ABSTRACT The beneficial effects of probiotic Enterococcus spp . in different hosts , such as mice and humans , have previously been reported in several studies . However , studies of large domestic animals , as well as challenge studies with pathogenic microorganisms , are very rare . Here , we investigated the influence of oral treatment of pigs with the probiotic bacterium Enterococcus faecium NCIMB 10415 on Salmonella enterica serovar Typhimurium DT104 infections in weaning piglets . Clinical symptoms , fecal excretion , the organ distribution of Salmonella , and the humoral immune response ( immunoglobulin G [ IgG ] , IgM , and IgA levels ) in serum were examined . A pool of 89 piglets was r and omly divided into probiotic and control groups . The probiotic group received a feed supplement containing E. faecium starting on day 14 postpartum prior to challenge with Salmonella serovar Typhimurium DT104 at 28 days postpartum . After challenge with Salmonella serovar Typhimurium DT104 , piglets in both groups showed no severe clinical signs of salmonellosis . However , fecal excretion and colonization of Salmonella in organs were significantly greater in piglets fed E. faecium . Likewise , the humoral immune response against Salmonella ( serum IgM and IgA levels ) was significantly greater in the probiotic group animals than in control animals . The results of this study suggest that E. faecium NCIMB 10415 treatment enhanced the course of infection in weaning piglets challenged with Salmonella serovar Typhimurium DT104 . However , the probiotic treatment also appeared to result in greater production of specific antibodies against Salmonella serovar Typhimurium DT104 ABSTRACT Contamination of meat products with food-borne pathogens usually results from the carcass coming in contact with the feces of an infected animal during processing . In the case of Salmonella , pigs can become colonized with the organism during transport and lairage from contaminated trailers and holding pens , result ing in increased pathogen shedding just prior to processing . Increased shedding , in turn , amplifies the likelihood of carcass contamination by magnifying the amount of bacteria that enters the processing facility . We conducted a series of experiments to test whether phage therapy could limit Salmonella infections at this crucial period . In a preliminary experiment done with small pigs ( 3 to 4 weeks old ; 30 to 40 lb ) , administration of an anti-Salmonella phage cocktail at the time of inoculation with Salmonella enterica serovar Typhimurium reduced Salmonella colonization by 99.0 to 99.9 % ( 2- to 3-log reduction ) in the tonsils , ileum , and cecum . To test the efficacy of phage therapy in a production-like setting , we inoculated four market-weight pigs ( in three replicates ) with Salmonella enterica serovar Typhimurium and allowed the challenged pigs to contaminate a holding pen for 48 h. Sixteen naïve pigs were r and omly split into two groups which received either the anti-Salmonella phage cocktail or a mock treatment . Both groups of pigs were comingled with the challenged pigs in the contaminated pen . Treatment with the anti-Salmonella phage cocktail significantly reduced cecal Salmonella concentrations ( 95 % ; P < 0.05 ) while also reducing ( numerically ) ileal Salmonella concentrations ( 90 % ; P = 0.06 ) . Additional in vitro studies showed that the phage cocktail was also lytic against several non-Typhimurium serovars Recent research has shown that much preharvest Salmonella enterica infection in pigs occurs immediately before slaughter during this rest period in the contaminated abattoir holding pens . The objective of this study was to evaluate a potential intervention strategy to reduce the prevalence of S. enterica-positive pigs at slaughter , which consisted of resting pigs prior to slaughter on their transport vehicle , instead of in the abattoir holding pen . Additionally , the effect of transportation of pigs from farm to the abattoir on S. enterica prevalence was investigated . A total of 120 animals were included in the experiment , divided in four replicates ( n = 30 pigs per replicate ) . Fecal sample s were collected from each animal at the farm and at the abattoir , where 15 r and omly chosen pigs were unloaded and moved to a holding pen , while the remaining 15 pigs stayed in the transport trailer . After approximately 1.5 h of resting , both groups were slaughtered . Sample s collected included distal ileum portion , cecal contents , and ileocecal lymph node . The overall S. enterica prevalence ( pigs positive in at least one of the sample s collected at slaughter ) was higher for pigs held in the abattoir pens ( 40.7 % versus 13.3 % , P < 0.05 ) . There was no difference ( P > 0.05 ) for the S. enterica prevalence before and after transportation from farm to abattoir ( 5.8 % versus 0.8 % , respectively ) . This study demonstrates that resting pigs on the transport vehicle has the potential to decrease S. enterica levels entering the abattoir This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence A mucosal competitive exclusion culture has been shown to reduce or eliminate Salmonella spp . in poultry . Using similar techniques , a mucosal competitive exclusion culture from swine ( MCES ) was produced from the cecum of a 6-week-old pig . Suckling pigs were inoculated with 5 ml of MCES by oral gavage within 6 h postfarrowing ( PF ) and again at 24 h PE All pigs were challenged with 10(3 ) CFU of Salmonella Choleraesuis at 48 h PF by intranasal instillation , including pigs from two sows that had not been given MCES . Clinical signs and rectal swabs were monitored daily , and pigs were allowed to suckle throughout the experiment . All pigs underwent necropsy on day 7 PF , and presence of Salmonella was determined in both qualitative ( 10 tissues ) and quantitative ( two tissues ) sample s. Clinical signs were inapparent in all pigs throughout the experiment . Recovery of Salmonella from rectal swabs was variable . However , 28 % of the gut tissues were positive from the MCES-treated pigs versus 79 % from the control pigs . A 2- to 5-log10 reduction of Salmonella in the cecal contents or ileocolic junction was observed in the MCES-treated pigs when compared with the controls . These data indicate that use of MCES may be a useful approach for control of Salmonella To estimate the global burden of nontyphoidal Salmonella gastroenteritis , we synthesized existing data from laboratory-based surveillance and special studies , with a hierarchical preference to ( 1 ) prospect i ve population -based studies , ( 2 ) " multiplier studies , " ( 3 ) disease notifications , ( 4 ) returning traveler data , and ( 5 ) extrapolation . We applied incidence estimates to population projections for the 21 Global Burden of Disease regions to calculate regional numbers of cases , which were summed to provide a global number of cases . Uncertainty calculations were performed using Monte Carlo simulation . We estimated that 93.8 million cases ( 5th to 95th percentile , 61.8 - 131.6 million ) of gastroenteritis due to Salmonella species occur globally each year , with 155,000 deaths ( 5th to 95th percentile , 39,000 - 303,000 deaths ) . Of these , we estimated 80.3 million cases were foodborne . Salmonella infection represents a considerable burden in both developing and developed countries . Efforts to reduce transmission of salmonellae by food and other routes must be implemented on a global scale Nontyphoidal salmonellosis is the second most frequently reported zoonotic disease in the European Union ( EU ) and is considered to be a major threat to human health worldwide . The most reported Salmonella serovar in the EU is S. Enteritidis , mainly associated with egg contamination , followed by S. Typhimurium , with the latter being the most predominant serovar isolated from pork . These findings suggest that reducing the Salmonella contamination in the pork production might be a good strategy to prevent and control human salmonellosis in the EU . Recently , a quantitative microbial risk assessment ( QMRA ) has been developed to assess the risks for human salmonellosis due to home consumption of fresh minced pork meat in Belgium . The newly developed risk model is called the METZOON model . In the current study , the METZOON model was used to evaluate the effectiveness of different hypothetical Salmonella mitigation strategies implemented at different stages of the minced pork production and consumption chain by means of a scenario analysis . To efficiently evaluate the mitigation strategies , model results were obtained by running simulations using the r and omized complete block design . The effectiveness of a mitigation strategy is expressed using point and interval estimates of the effect size for dependent observations , expressed as the st and ardized difference in population means . The results indicate that the most effective strategies are taken during the slaughter processes of polishing , evisceration , and chilling , and during postprocessing , whereas interventions in the primary production and at the beginning of the slaughter process seem to have only a limited effect . Improving consumer awareness is found to be effective as well This study was design ed to compare Salmonella enterica prevalence in sows held in a holding pen at the abattoir for approximately 2 h ( hold sows ) with sows slaughtered immediately after transport to the abattoir ( no-hold sows ) . Cull sows ( n = 160 ) were sample d from four sampling periods over 8 weeks ( February to March 2002 ) at the abattoir . Sows originated from an integrated swine farm and were sent to a live-hog market and then to the slaughter facility . Before testing , sows entered the abattoir pen and four 100-cm2 four-ply gauze squares were placed r and omly on the pen floor for S. enterica culture . Sows were alternatively assigned to the hold or no-hold group . Sample s collected from sows during slaughter were ileocecal lymph node , cecal contents , transverse colon contents , subiliac lymph node , sponge swabs of the left and right carcass section ( 300 cm2 ) , and chopped meat . Overall , S. enterica was isolated from 44 % ( 35 of 80 ) of the no-hold sows , which was significantly less ( P < 0.05 ) than 59 % ( 47 of 80 ) of the held sows . Also , no-hold sows had a lower cecal content prevalence ( 39 % , 31 of 80 ) compared with that ( 55 %
Output:
| We hypothesize that the presence of absence of one or more of these predictors across studies could help to explain the inconsistent and /or non-significant findings reported for some interventions applied at lairage |
MS213113 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A multicentre clinical trial , including 19 centres in 13 countries , assessed the contraceptive efficacy and clinical acceptability of a Silastic 382 vaginal ring releasing 20 micrograms of levonorgestrel for at least 90 days . A total of 1005 women entered the study and 8176.74 woman-months of experience was gathered . The rate of intrauterine pregnancy at one year of use was 3.6 per 100 women ( 95 % confidence interval 2.2 - 5.0 ) , and of ectopic pregnancy , 0.2 % ( one case ) . The principal reasons for discontinuation were menstrual disturbances ( 17.2 % at one year ) , vaginal symptoms ( 6.0 % ) and repeated expulsion of the ring ( 7.1 % ) . The pregnancy rate with this 20 micrograms levonorgestrel-releasing vaginal ring compares favourably with that of a low estrogen combination oral contraceptive tested by WHO and is less than half that of a progestogen-only oral contraceptive in a WHO r and omized study . It is concluded that the WHO intravaginal ring releasing an average of 20 micrograms of levonorgestrel per 24 hours is an effective method of contraception for at least one year of use OBJECTIVE To compare the effects of a pill containing drospirenone with those of a combined contraceptive vaginal ring on the lipid and carbohydrate metabolism and on the surrogate markers of arterial function . SETTING Bologna University School of Medicine . PATIENT(S ) Thirty-seven women with polycystic ovary syndrome ( PCOS ) were r and omly su bmi tted to drospirenone+ethinylestradiol ( group I ; n=19 ) or combined contraceptive vaginal ring ( group II ; n=18 ) therapy . The duration of the study was 6 months . INTERVENTION(S ) The effect of treatments was assessed after 6 months of therapy . MAIN OUTCOME MEASURE(S ) Utero-ovarian ultrasound analysis and color Doppler evaluation of uterine and stromal ovarian arteries . In addition , analysis of brachial artery flow-mediated vasodilatation and 24-hour ambulatory blood pressure monitoring were performed . Fasting blood sample s were drawn for testing biochemical and hormonal parameters and nitrites/nitrates . RESULT ( S ) Both treatments improved hirsutism , hyper and rogenemia , and ultrasound and color Doppler ovarian parameters . Both drospirenone+ethinylestradiol or contraceptive vaginal ring induced a slight but significant increase of diurnal and 24-hour blood pressure . Although both therapies worsened the lipid profile , the oral pill administration was associated with a more evident increase of circulating triglycerides . The 6-month treatment with the vaginal ring significantly improved the area under the curve for glucose , insulin , and C-peptide , whereas the drospirenone+ethinylestradiol pill induced an increase in the insulinogenic index and homeostatic model assessment estimate for insulin resistance values . CONCLUSION ( S ) Vaginal hormonal contraception appears to be preferable to oral ethinylestradiol + drospirenone administration in hyperinsulinemic patients with PCOS Background It is increasingly acknowledged that ‘ acceptability ’ should be considered when design ing , evaluating and implementing healthcare interventions . However , the published literature offers little guidance on how to define or assess acceptability . The purpose of this study was to develop a multi-construct theoretical framework of acceptability of healthcare interventions that can be applied to assess prospect i ve ( i.e. anticipated ) and retrospective ( i.e. experienced ) acceptability from the perspective of intervention delivers and recipients . Methods Two methods were used to select the component constructs of acceptability . 1 ) An overview of review s was conducted to identify systematic review s that cl aim to define , theorise or measure acceptability of healthcare interventions . 2 ) Principles of inductive and deductive reasoning were applied to theorise the concept of acceptability and develop a theoretical framework . Steps included ( 1 ) defining acceptability ; ( 2 ) describing its properties and scope and ( 3 ) identifying component constructs and empirical indicators . Results From the 43 review s included in the overview , none explicitly theorised or defined acceptability . Measures used to assess acceptability focused on behaviour ( e.g. dropout rates ) ( 23 review s ) , affect ( i.e. feelings ) ( 5 review s ) , cognition ( i.e. perceptions ) ( 7 review s ) or a combination of these ( 8 review s).From the methods described above we propose a definition : Acceptability is a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate , based on anticipated or experienced cognitive and emotional responses to the intervention . The theoretical framework of acceptability ( TFA ) consists of seven component constructs : affective attitude , burden , perceived effectiveness , ethicality , intervention coherence , opportunity costs , and self-efficacy . Conclusion Despite frequent cl aims that healthcare interventions have assessed acceptability , it is evident that acceptability research could be more robust . The proposed definition of acceptability and the TFA can inform assessment tools and evaluations of the acceptability of new or existing interventions In sub-Saharan Africa , HIV incidence and prevalence remain disproportionately high among women . Vaginal rings ( VRs ) have been formulated for the delivery of antiretroviral-based microbicides , and their favorable safety and tolerability profiles reported in clinical studies . Although the concept of drug release through a VR has existed since 1970 , and VRs have been marketed since 1992 for contraceptive or hormone replacement purpose s , VR use as a microbicide delivery system is a novel application . This is the first study to evaluate VR adherence among African women in the context of its potential use as an HIV prevention method , to examine predictors of adherence , and to describe clinical or context ual reasons for VR removals or nonadherence . This was a r and omized trial of the safety and acceptability of a placebo VR worn for 12 weeks in 170 HIV-negative , African women aged 18–35 in four clinic sites in South Africa and Tanzania . The findings suggest that adherence to VR use in the context of HIV prevention trials in these communities should be high , thereby enabling more accurate assessment of an active microbicide safety and efficacy End-user input is critical to inform development of multi purpose prevention technology ( MPT ) products that prevent HIV and pregnancy . The TRIO Study , conducted in Kenya and South Africa , enrolled 277 HIV-negative women aged 18–30 in a r and omized cross-over study to use each placebo MPT ( daily oral tablets , monthly injections , and monthly vaginal ring ) for one month . At the end of each month , participants rated how much they liked using the product on a 5-point Likert scale ( 5 = liked very much ) . We compared mean ratings using paired t-tests and examined sociodemographic- , attribute- , and behavior-related characteristics associated with ratings using multivariable linear regression and data from in-depth interviews . After use , mean ratings were significantly higher for injections [ 4.3 ( SD = 1.0 ) ] compared with tablets [ 3.0 ( SD = 1.3 ) ] and rings [ 3.3 ( SD = 1.4 ) ] ( p < 0.001 ) ; mean ratings for rings were significantly higher than for tablets ( p = 0.013 ) . Mean ratings of a hypothetical active MPT increased for all products after the one-month period of use , with the greatest increase for rings , the least familiar product . In multivariable analysis , acceptability of key product attributes ( e.g. , product look ) were associated with a significant increase of ≥ 1 point in the mean rating across all three products ( p ≤ 0.001 ) . Perceived ability to use the product without partner knowledge was associated with a higher mean rating for rings ( b = 0.50 ; p = 0.006 ) . The acceptability of product attributes contributed significantly to the rating of all products , highlighting the value of choice in pregnancy and HIV prevention to accommo date diverse users Abstract Introduction Preventing HIV and unintended pregnancies are key global health priorities . To inform product rollout and to underst and attributes of future multi purpose prevention technologies ( MPT ) associated with preference and use , we evaluated three placebo delivery forms : daily oral tablets , a monthly vaginal ring , and two monthly intramuscular injections in TRIO , a five‐month study among young Kenyan and South African women . Methods HIV‐negative , sexually active , non‐pregnant women aged 18 to 30 were enrolled and r and omized to use each placebo delivery form for one month ( stage 1 ) . Then , participants chose one product to use for two additional months ( stage 2 ) . We assessed safety , product ranking , choice , and use . We examined demographic and behavioural correlates of choice and , reciprocally , unwillingness to use in the future with logistic regression models . Results 277 women enrolled , 249 completed stage 1 and 246 completed stage 2 . Median age was 23 years , 49 % were Kenyan and 51 % were South African . Three participants became pregnant during the study and one participant HIV‐seroconverted . There were 18 product‐related adverse events , six tablets‐related , 11 ring‐related , and one injection‐related . After trying each product , 85 % preferred a TRIO product over condoms . Injections were chosen most ( 64 % , 95 % confidence interval ( CI ) 58 % , 70 % ; p < 0.001 ) , and by more South Africans than Kenyans ( odds ratio ( OR ) 2.01 , 95 % CI : 1.17 , 3.43 ; p = 0.01 ) . There was no significant difference in choosing tablets versus ring ( 21 % , 95 % CI : 16 % , 26 % vs. 15 % , 95 % CI : 11 % , 20 % ; p = 0.11 ) . Tablet and ring adherence , based on direct observations and self‐reports , improved over time . However , participants ’ self‐reported use of tablets did not match objective data from the electronic dose monitoring device . Participants were fully compliant with injections . Conclusion In this population at risk for HIV and pregnancy , all participants agreed to choose and use a placebo MPT delivery form . A majority of participants preferred TRIO products to male condoms , an existing MPT . Injections were most liked and best used , however , they are years away from reaching the clinics . In the meantime , exp and ing the availability of tablets and giving access to rings can begin to fulfill the promise of choice for HIV prevention technologies and inform the development of suitable delivery forms as MPT PURPOSE A crossover study was carried out in 405 couples to compare women 's difficulties with three different devices that could be used to administer a microbicide and to evaluate adherence to use and preference for any one of the devices . METHODS Couples used a single size diaphragm , a vaginal ring or disposable applicators for 1 month each in a r and omly assigned order . RESULTS Few women reported difficulty using the applicators or the ring ; however , almost two-thirds reported difficulty using the diaphragm . Approximately 5 % , 10 % and 40 % of the women and a similar but slightly lower percentage of their partners reported incorrect use of the applicator , vaginal ring and diaphragm , respectively . About half the women preferred the vaginal ring , while around half the men preferred the applicator . CONCLUSION The release of microbicides from a vaginal ring is a lead worth pursuing . The diaphragm is the only one of the three devices that also offers mechanical protection , but it requires greater investment in patient education to ensure adherence to use 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 open-label , r and omized study compared the pharmacokinetics of ethinylestradiol ( EE ) from the contraceptive vaginal ring NuvaRing ( 15 microg EE/day ) , the transdermal patch ( 20 microg EE/day ) and a combined oral contraceptive ( COC ) containing 30 microg EE . After 2 - 8 weeks of synchronization by COC treatment , subjects were r and omized to 21 days of treatment with NuvaRing , patch or COC . Analysis of area under the EE concentration-versus-time curve ( AUC ) during 21 days of treatment showed that exposure to EE in the NuvaRing group was 3.4 times lower than in the patch group ( p < .05 ) and 2.1 times lower than in the pill group ( p < .05 ) . Serum EE levels of subjects showed much lower variation with NuvaRing than with the patch or the COC . Thus , exposure to EE was significantly lower with NuvaRing than with the patch and pill methods , demonstrating that NuvaRing is a low-estrogen-dose contraceptive method that also results in low estrogen exposure OBJECTIVE To assess the efficacy , tolerability , and acceptance of a vaginal ring delivering the equivalent of 50 or 100 microg per day of estradiol ( E2 ) , compared with placebo , for relief of moderate to severe vasomotor symptoms and urogenital symptoms in postmenopausal women . METHODS Women with moderate to severe vasomotor symptoms ( seven or more per day or 56 per week average ) received 13 weeks of treatment with a vaginal ring delivering 50
Output:
| Acceptability improved over time both within studies ( as women gained VR experience and worries diminished ) , and over chronological time ( as the device was popularized ) .
Women expressed preferences for accessible , long-acting , partner-approved methods that prevent both HIV and pregnancy , can be used without partner knowledge , and have no impact on sex and few side effects .
This systematic review suggests that most LMIC women users have a positive view of the VR that increases with familiarity of use ; and , that many would consider the VR an acceptable future delivery device for HIV prevention or other indications |
MS213114 | ***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 examine the relationship of early human embryonic development with the level of reactive oxygen species ( ROS ) in the culture media on the first day ( day 1 ROS ) after insemination . DESIGN A prospect i ve study . SETTING Patients undergoing assisted reproduction in a teaching hospital . PATIENT(S ) Patients undergoing conventional IVF ( n = 104 ; 115 cycles ) and intracytoplasmic sperm injection ( ICSI ) ( n = 91 ; 96 cycles ) were included . Both fertilization and early cultures were performed in human tubal fluid with 5 % serum substitute supplement . INTERVENTION(S ) Day 1 ROS levels in the central well ( sample ) and the outer well ( control ) of each embryo culture dish were measured after overnight incubation by chemiluminescence assay using luminol as the probe . MAIN OUTCOME MEASURE(S ) Fertilization rate and embryo quality at day 3 and 5 were recorded for each cycle . Age , parity , and demographic features were also compared . RESULT ( S ) High day 1 ROS levels in culture media were associated with low blastocyst rate , low fertilization rate , low cleavage rate , and high embryonic fragmentation with ICSI but not with conventional IVF . High day 1 ROS levels in culture media were associated with lower pregnancy rates in both IVF and ICSI cycles . CONCLUSION ( S ) Reactive oxygen species generated in culture media by day 1 may be an important biochemical marker for early embryonic growth . Increased embryonic fragmentation and slow cleavage rate may be partially attributed to early exposure of embryos to high ROS levels in ICSI cycles . Differential growth of ICSI embryos incubated under identical conditions may be in part due to differences in ROS levels of the culture medium surrounding these embryos A prospect i ve , r and omized study of 158 patients undergoing in-vitro fertilization ( IVF ) and embryo transfer was conducted to evaluate whether a shortened exposure of oocytes to spermatozoa enhances oocyte development , and subsequently influences the IVF outcome . A comparison was made between conventional treatment time and shorter exposure of retrieved oocytes to spermatozoa . Fertilization and cleavage rates , embryo quality , implantation and pregnancy rates in the study group ( short exposure ) versus controls ( st and ard IVF procedure ) were evaluated . Fertilization ( 56 versus 61 % ) and cleavage rates ( 96 versus 92 % ) were similar in the two groups respectively . However , embryo quality was significantly higher in the study group ( P < 0.05 ) . Moreover , the pregnancy and implantation rates were significantly increased ( 42.4 versus 26 % per embryo transfer , and 16 versus 10 % respectively ; P < 0.05 ) . Our results demonstrated that shorter exposure of oocytes to spermatozoa is superior to the st and ard time in IVF and may have a favourable effect on implantation rates by improving embryo quality OBJECTIVE To confirm whether brief exposure of human oocytes to spermatozoa in vitro results in equivalent fertilization rates and possibly better quality embryos than overnight coincubation and to determine if there was a difference in outcome with regard to the type of culture medium used . DESIGN Prospect i ve distribution of gametes between treatments in sequential patients . SETTING Assisted reproductive technology program in private hospital . PATIENT(S ) Consecutively treated subfertile couples entering an infertility program . INTERVENTION(S ) Assisted reproductive technology treatment for infertility involving oocyte retrieval and in vitro fertilization . MAIN OUTCOME MEASURE(S ) When possible , the outcome of fertilization and embryo quality were compared when gametes were coincubated for 1 hour or overnight . Two different formulations of human tubal fluid were compared in some cases . RESULT ( S ) There was no statistically significant difference in fertilization rates between a brief or overnight coincubation of gametes or between the two treatment groups with regard to the type of culture medium used . The quality of the embryos was significantly better in the 1-hour exposure group . The embryos in Basal XI human tubal fluid medium were of significantly better morphological quality than their siblings in D3 + human tubal fluid medium . CONCLUSION ( S ) Coincubation of oocytes and spermatozoa for a shorter period produced embryos of superior morphological quality than the generally accepted overnight protocol . A simple glucose and phosphate-free human tubal fluid medium result ed in early cleavage embryos of better morphological quality than a medium supplemented with glucose , taurine , and glutathione Human oocyte development was evaluated after a reduced time exposure to spermatozoa in vitro . A total of 119 patients were assigned to two study groups in a r and omized prospect i ve study in which each patient 's oocytes were exposed to spermatozoa for either 1 h ( group 1 - 58 patients ) or the st and ard 16 h incubation period ( group 2 - 61 patients ) . The fertilization rate obtained in group 1 was higher than in group 2 ( 285/393 , 73 % , and 272/410 , 66 % respectively ) , suggesting that the spermatozoa-oocyte interaction occurs within 1 h. This was confirmed in a study in vitro using fluorescently labelled spermatozoa and normal oocyte-cumulus complexes . Spermatozoa enter the cumulus complex within 15 min , traverse the cumulus layer within 3 h , and first appear in the oocyte cortex at 4 h post-insemination . The incidence of polyspermy was higher in oocytes exposed to spermatozoa for 16 h ( 3 % ) than for 1 h ( 1 % ) . There was no difference in the cleavage rate or morphological characteristics of embryos from both study groups . However , when evaluating the timing of embryo development , group 1 generated a significantly higher percentage of four to five cell embryos when compared to group 2 ( 55 versus 39 % ; P < 0.001 ) , documented at 40 h post-insemination . The implantation and pregnancy rates for group 1 were 11 and 28 % , while the corresponding rates for group 2 were 8 and 15 % . This suggests that a reduced exposure of oocyte to spermatozoa favours embryo viability , possibly due to a decrease in potential damage from sperm metabolic waste products OBJECTIVE To examine the effects of increased sperm DNA damage in relation to seminal oxidative stress in men with idiopathic and male factor infertility . Prospect i ve study . SETTING S Infertility clinic at a tertiary care academic institution . PATIENT(S ) Ninety-two infertile men with normal female partners . Sixteen fertile donors served as the control group . INTERVENTION(S ) St and ard semen analysis and assessment of levels of seminal oxidative stress . Assisted reproductive techniques in 33 of the 92 patients ( IUI [ n = 19 ] , IVF [ n = 10 ] , and intracytoplasmic sperm injection [ n = 4 ] ) . MAIN OUTCOME MEASURE(S ) Sperm DNA damage by sperm chromatin structure assay . Results were expressed as DNA fragmentation index . RESULT ( S ) Patients were classified as having either idiopathic ( n = 23 ) or male factor infertility ( n = 69 ) . Patients with idiopathic and male factor infertility had significantly higher DNA fragmentation index and oxidative stress compared with the case of fertile donors . A clinical pregnancy was achieved in 9 ( 27 % ) of 33 patients with assisted reproductive techniques . Significantly higher DNA fragmentation index and oxidative stress were found in men who failed to initiate a pregnancy after assisted reproductive techniques ( n = 24 ) , compared with the cases of those who succeeded and of the fertile donors . DNA fragmentation index was correlated positively with oxidative stress ( r = 0.27 ) , and negatively with fertilization ( r = -0.70 ) and embryo quality ( r = -0.70 ) . CONCLUSION ( S ) Sperm DNA damage is significantly increased in men with idiopathic and male factor infertility and in men who failed to initiate a pregnancy after assisted reproductive techniques . Such an increase may be related to high levels of seminal oxidative stress Purpose : Recent studies showed a beneficial effect of reducing the time of sperm – oocyte interaction on fertilization , division , and implantation rates of the oocytes obtained from r and omized patients . In the present study , the effects of reduced insemination time on fertilization and embryo development were evaluated by using sibling oocytes from the same patient . Methods : A total of 464 oocytes from 36 patients was r and omly allocated to be inseminated for either 1 hr ( reduced ) or 18 hr ( regular ) . Results : Fertilization rates were not significantly different between reduced ( 135/229 ; 59 % ) and regular ( 150/235 ; 64 % ) groups . Cleavage rates and embryo quality were similar in both groups . A total of 135 embryos ( 73 from the reduced and 62 from the regular group ) was transferred to 36 patients . Thirty-four embryos implanted in 18 patients ( 25.2 % implantation and 50.0 % pregnancy rates ) . Conclusions : Fertilization , cleavage , and embryo development from 1-hr insemination is comparable , not superior , to those from an 18-hr insemination time , which is commonly used in in vitro fertilization programs . These data suggest that reduced insemination time can be used during in vitro fertilization to avoid unnecessarily longer exposure to spermatozoa BACKGROUND Traditionally oocytes have been exposed to sperm overnight , for 16 - 20 h. This long period of co-incubation , however , has been shown to create problems with high levels of reactive oxygen species ( ROS ) , which may affect embryo viability and cause hardening of the zona pellucida . Recently , a positive effect of reducing the co-incubation time to 90 - 120 min was reported . The objective of this study was to evaluate whether a further reduction of the co-incubation period could benefit the outcome of IVF . METHODS In this prospect i ve study , 777 sibling oocytes from 81 women undergoing IVF were divided via alternate allocation to co-incubation for either 30 s ( ultrashort co-incubation ) ( group A ) or for 90 min ( st and ard co-incubation ) ( group B ) . Endpoints were normal fertilization ( two-pronuclear , 2PN ) , polyspermy ( > 2PN ) , embryo quality ( EQ ) , clinical pregnancy ( CP ) and implantation ( IR ) . RESULTS The normal fertilization rates of the two groups were comparable : group A 58.6 % versus group B 58.0 % . Significantly lower rates of polyspermy were seen in group A compared to group B ( 2.8 versus 7.2 % , P = 0.008 ) . No statistically significant differences in EQ , CP or IR were seen . CONCLUSION This is the first study demonstrating the achievement of good fertilization rates in IVF with ultrashort co-incubation . Significantly lower rates of polyspermy were seen in the group with ultrashort compared to the st and ard co-incubation group . Further studies are , however , needed in order to evaluate whether ultrashort co-incubation has any effect on the outcome of IVF Altering the coincubation time for spermatozoa and oocytes in vitro leads to varying results . Some authors suggest that longer exposure of spermatozoa to oocytes through coincubation is detrimental to fertilization and /or embryo development , possibly because of reactive oxygen species produced by the spermatozoa ( 1–5 ) . Other studies indicate that a decreased exposure time does not alter fertilization rates ( 3,6–9 ) and may even improve such rates ( 10–13 ) . In this report , we describe the results of our r and omized study on the effects of two coincubation times on in vitro fertilization ( IVF ) rates and embryo quality OBJECTIVE To evaluate sperm DNA fragmentation and semen parameters to diagnose male factor infertility and predict pregnancy after IVF . DESIGN Prospect i ve study . SETTING Academic research laboratory . PATIENT(S ) Seventy-five couples undergoing IVF and 28 fertile donors . INTERVENTION(S ) Sperm DNA fragmentation was measured by the alkaline Comet assay in semen and sperm after density gradient centrifugation ( DGC ) . Binary logistic regression was used to analyze odds ratios ( OR ) and relative risks ( RR ) for IVF outcomes . MAIN OUTCOME MEASURE(S ) Semen parameters and sperm DNA fragmentation in semen and DGC sperm compared with fertilization rates , embryo quality , and pregnancy . RESULT ( S ) Men with sperm DNA fragmentation at more than a diagnostic threshold of 25 % had a high risk of infertility ( OR : 117.33 , 95 % confidence interval [ CI ] : 12.72 - 2,731.84 , RR : 8.75 ) . Fertilization rates and embryo quality decreased as sperm DNA fragmentation increased in semen and DGC sperm . The risk of failure to achieve a pregnancy increased when sperm DNA fragmentation exceeded a prognostic threshold value of 52 % for semen ( OR : 76.00 , CI : 8.69 - 1,714.44 , RR : 4.75 ) and 42 % for DGC sperm ( OR : 24.18 , CI : 2.
Output:
| This review has provided evidence that brief co-incubation of sperm and oocytes may improve the ongoing pregnancy and clinical pregnancy rates for infertile women undergoing IVF cycles . |
MS213115 | ***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 : No r and omised studies have addressed whether self-management for asthma can be successfully delivered by community pharmacists . Most r and omised trials of asthma self-management have recruited participants from secondary care ; there is uncertainty regarding its effectiveness in primary care . A r and omised controlled study was undertaken to determine whether a community pharmacist could improve asthma control using self-management advice for individuals recruited during attendance at a community pharmacy . Methods : Twenty four adults attending a community pharmacy in Tower Hamlets , east London for routine asthma medication were r and omised into two groups : the intervention group received self-management advice from the pharmacist with weekly telephone follow up for 3 months and the control group received no input from the pharmacist . Participants self-completed the North of Engl and asthma symptom scale at baseline and 3 months later . Results : The groups were well matched at baseline for demographic characteristics and mean ( SD ) symptom scores ( 26.3 ( 4.8 ) and 27.8 ( 3.7 ) in the intervention and control groups , respectively ) . Symptom scores improved in the intervention group and marginally worsened in the control group to 20.3 ( 4.2 ) and 28.1 ( 3.5 ) , respectively ( p<0.001 ; difference adjusted for baseline scores = 7.0 ( 95 % CI 4.4 to 9.5 ) . Conclusions : A self-management programme delivered by a community pharmacist can improve asthma control in individuals recruited at a community pharmacy . Further studies should attempt to confirm these findings using larger sample s and a wider range of outcome measures The complex intervention methodology framework defines the iterative process for developing and evaluating complex interventions in healthcare , but advice on implementation research was not included until the 2008 up date . Our recent systematic review of implementation studies identified significant problems with reporting st and ards , including inconsistent terminology and crucial information that was missing or unclear . Introduction of reporting checklists has st and ardized the reporting of r and omized controlled trials and other types of studies , and there is a need for similar guidance for reporting implementation studies . Key st and ards might include an explicit evidence base from a r and omized controlled trial or guideline recommendation ; recruitment to the clinical service , not the research ; at least some outcomes at the population level using routinely collected data ; and a description of the setting and the process of implementing the service . The complex intervention framework currently illustrates a cycle of development and evaluation , which includes implementation as a final step . We propose that the research underpinning implementation should be visualized as a second interrelated cycle . Just as the " phase III cycle " includes the iterative steps of development and piloting , a similar process may be needed to translate the intervention into a practical service that can be tested in a phase IV implementation study 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 pharmacists would have asthma patients allocated to enhanced ( pharmaceutical ) care ( EC ) or usual care ( UC ) . Pharmacists less experienced were clustered by geography and had their pharmacies r and omized to two levels of care ; each pharmacy then had patients r and omized to EC versus control , UC versus control or EC versus UC depending on their pharmacy r and omization . Six hundred thirty-one patients provided consent , of which 225 in EC or UC were analyzed for all outcomes . Patients were followed for one year . RESULTS Compared with patients in the UC group , the results of those in the EC group were as follows : symptom scores decreased by 50 % ; peak flow readings increased by 11 % ; days off work or school were reduced by approximately 0.6 days/month ; use of inhaled beta-agonists was reduced by 50 % ; overall quality of life improved by 19 % , and the specific domains of activity limitations , symptoms and emotional function also improved ; initial knowledge scores doubled ; emergency room visits decreased by 75 % ; and medical visits decreased by 75 % . A patient satisfaction survey revealed that the population was extremely pleased with their pharmacy services . Cost analysis reinforces the EC model , which is more cost effective than UC in terms of most direct and indirect costs in asthma patients . CONCLUSION Specially trained community pharmacists in Canada , using a pharmaceutical care-based protocol , can produce impressive improvements in clinical , economic and humanistic outcome measures in asthma patients . The health care system needs to produce incentives for such care Background : Despite national disease management plans , optimal asthma management remains a challenge in Australia . Community pharmacists are ideally placed to implement new strategies that aim to ensure asthma care meets current st and ards of best practice . The impact of the Pharmacy Asthma Care Program ( PACP ) on asthma control was assessed using a multi-site r and omised intervention versus control repeated measures study design . Methods : Fifty Australian pharmacies were r and omised into two groups : intervention pharmacies implemented the PACP ( an ongoing cycle of assessment , goal setting , monitoring and review ) to 191 patients over 6 months , while control pharmacies gave their usual care to 205 control patients . Both groups administered question naires and conducted spirometric testing at baseline and 6 months later . The main outcome measure was asthma severity/control status . Results : 186 of 205 control patients ( 91 % ) and 165 of 191 intervention patients ( 86 % ) completed the study . The intervention result ed in improved asthma control : patients receiving the intervention were 2.7 times more likely to improve from “ severe ” to “ not severe ” than control patients ( OR 2.68 , 95 % CI 1.64 to 4.37 ; p<0.001 ) . The intervention also result ed in improved adherence to preventer medication ( OR 1.89 , 95 % CI 1.08 to 3.30 ; p = 0.03 ) , decreased mean daily dose of reliever medication ( difference −149.11 μg , 95 % CI −283.87 to −14.36 ; p = 0.03 ) , a shift in medication profile from reliever only to a combination of preventer , reliever with or without long-acting β agonist ( OR 3.80 , 95 % CI 1.40 to 10.32 ; p = 0.01 ) and improved scores on risk of non-adherence ( difference −0.44 , 95 % CI −0.69 to −0.18 ; p = 0.04 ) , quality of life ( difference −0.23 , 95 % CI −0.46 to 0.00 ; p = 0.05 ) , asthma knowledge ( difference 1.18 , 95 % CI 0.73 to 1.63 ; p<0.01 ) and perceived control of asthma question naires ( difference −1.39 , 95 % CI −2.44 to −0.35 ; p<0.01 ) . No significant change in spirometric measures occurred in either group . Conclusions : A pharmacist-delivered asthma care programme based on national guidelines improves asthma control . The sustainability and implementation of the programme within the healthcare system remains to be investigated Education on optimal medication use is an essential strategy to improve asthma control . The current authors investigated whether pharmacist interventions , focused on appropriate use of asthma medication and tailor-made to the patient 's current asthma control , would improve asthma control in adult patients . A 6-month r and omised , controlled , parallel-group trial was conducted in 66 community pharmacies in Belgium . Patients were r and omly assigned to receive usual pharmacist care ( n = 94 ) or a pre-defined pharmacist intervention ( n = 107 ) . This intervention mainly focused on improving inhalation technique and medication adherence . Primary outcome was the level of asthma control , as assessed by the Asthma Control Test ® ( ACT ) . Mean ACT scores did not change from baseline for both study groups . However , a pre-defined subgroup analysis of patients having insufficiently controlled asthma at baseline showed that the intervention had significantly increased the ACT score after 6 months compared with usual care . The intervention also reduced , for the complete study group , reliever medication use and the frequency of night-time awakenings due to asthma . Inhalation technique and adherence to controller medication were significantly better in the intervention group . In conclusion , pragmatic community pharmacy-based programmes can significantly improve therapeutic outcomes in adult asthma patients RATIONALE , AIMS AND OBJECTIVES DEPICT ( Descriptive Elements of Pharmacist Intervention Characterization Tool ) was created in response to the frequently reported issue of poor intervention description across studies assessing the impact of clinical pharmacy activities . The aim of this study was to create an improved version of DEPICT ( i.e. DEPICT 2 ) to better characterize clinical pharmacy services in order to ensure consistent reporting , therefore enhancing reproducibility of interventions in practice . METHOD A qualitative approach through a thematic content analysis was performed to identify components of pharmacist interventions described in 269 r and omized controlled trials . A preliminary version of DEPICT 2 was applied independently by two authors to a r and om sample of 85 of the 269 RCTs and reliability determined by the prevalence-adjusted bias-adjusted kappa ( PABAK ) or the intraclass correlation coefficient ( ICC ) . The final version of DEPICT 2 was compared against DEPICT 1 . RESULTS The final version of DEPICT 2 comprised 146 items and 11 domains . The inter-rater agreement analysis showed that DEPICT presented good to optimal reproducibility , with a mean PABAK value of 0.87 ( 95 % CI 0.85 - 0.89 ) and a mean ICC value of 0.88 ( 95 % CI 0.62 - 1.14 ) . The mean difference between items checked in the two versions ( DEPICT 2 - DEPICT 1 ) was 10.58 ( 95 % CI 9.55 - 11.61 ) , meaning that approximately 11 more components were identified in the new version of DEPICT . CONCLUSIONS DEPICT 2 is a reliable tool to characterize components of clinical pharmacy services , which should be used to ensure consistent reporting of interventions to allow their reproducibility in practice Objective To assess the impact of an intervention initiated by community pharmacists , involving the provision of educational material and general practitioner ( GP ) referral , on asthma knowledge and self-reported asthma control and asthma-related quality of life ( QOL ) in patients who may have suboptimal management of their asthma , as evidence d by pharmacy dispensing records . Setting Community pharmacies throughout Tasmania , Australia . Methods Forty-two pharmacies installed a software application that data mined dispensing records and generated a list of patients with suboptimal asthma management , as indicated by having three or more canisters of inhaled short-acting beta-2-agonists dispensed in the preceding 6 months . Identified patients were r and omised to an intervention or control group . At baseline , intervention patients were mailed intervention packs consisting of a letter encouraging them to see their GP for a review , educational material , asthma knowledge , asthma control and asthma-related QOL question naires , and a letter with a dispensing history to give to their GP . Pharmacists were blinded to the control patients ’ identities for 6 months , after which time intervention patients were sent repeat question naires , and control patients were sent intervention packs . Main outcome measures Asthma knowledge , asthma control and asthma-related QOL scores . Results Thirty-five pharmacies completed the study , providing 706 intervention and 427 control patients who were eligible to receive intervention packs . Intervention patients ’ asthma control and asthma-related QOL scores at 6 months were significantly higher compared to the control patients ( P < 0.01 and P < 0.05 , respectively ) and to the intervention patients ’ baseline scores ( P < 0.001 and P < 0.05 , respectively ) . Symptom-related QOL was significantly higher compared to the control patients ( P < 0.01 ) and activities-related QOL significantly improved compared to baseline ( P < 0.05 ) . No significant change was observed in asthma knowledge . Conclusion The results suggest that community pharmacists are ideally placed to identify patients with suboptimal asthma management and refer such patients for a review by their GP . This type of collaborative intervention can significantly improve self-reported asthma control and asthma-related QOL in patients identified as having suboptimal management of their asthma . A larger trial is needed to confirm the effects are real and sustained Objectives To implement and assess hospital-based pharmaceutical care services for patients with asthma . Methods A prospect i ve , r and omized , controlled study was conducted in Shaab teaching hospital , Khartoum , Sudan . Patients were allocated r and omly either in the intervention group ( 60 ) or control group ( 40 ) patients . The drug therapy of asthma for the patients in the intervention group was review ed by a trained pharmacist , and interventions were suggested to the attending physicians for the identified problems . Intervention patients received comprehensive medication couns
Output:
| Pharmacists ' interventions in asthma management are complex .
Structured educational programs and patient counseling appear to be the most frequent core components of pharmacists ' interventions .
However , most studies failed to report the intervention dose sufficiently to be reproduced . |
MS213116 | ***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 determine whether prenatal corticosteroid therapy would reduce the incidence of neonatal necrotizing enterocolitis ( NEC ) , we assigned a total of 466 women admitted in premature labor either to receive placebo ( group A , n = 256 ) , if delivery was expected to occur within 24 hours of admission , or to receive betamethasone ( group B , n = 210 ) if delivery was expected to take place more than 24 hours after admission . All women were free of severe medical complications or drug therapy ; cases of intrauterine growth retardation or premature rupture of the membranes were excluded . Their newborn infants , excluding malformed , congenitally infected , and growth-retarded infants , were enrolled in the study unless they had died before the age of 10 postnatal days . Babies born to group A mothers ( n = 248 ) were further assigned to a treatment group ( group A1 , n = 130 ) receiving dexamethasone , 2 mg/kg/day by intravenous injection during the first 7 days of life , or to a control group ( group A2 , n = 118 ) receiving 10 % dextrose solution placebo . Group B infants ( prenatal betamethasone , n = 205 ) received neither treatment nor placebo . The incidence of NEC in group A1 was 6.9 % ( 9/130 ) , and in group A2 it was 14.4 % ( 17/118 ) ( p less than 0.05 ) . In group B the incidence was 3.4 % ( 7/205 ) ; this was much lower than in group A2 ( p less than 0.01 ) and lower than in group A combined ( 10.4 % ) ( p less than 0.01 ) . There was no death from NEC and no surgical intervention among group B patients . The mortality rate for group A1 ( 11 % ) was lower than for group A2 ( 56 % ) ( p less than 0.02 ) . There were fewer indications for surgical intervention for NEC in group A1 than in group A2 . Histologic studies confirmed bowel ischemia in all specimens analyzed . These data support the hypothesis that the incidence of NEC is significantly reduced after prenatal steroid treatment . Although postnatal therapy with steroids does not decrease the incidence as effectively as prenatal therapy , it improves clinical outcome of NEC A double-blind study was design ed to investigate the effects of antenatal glucocorticoids on the incidence of respiratory distress syndrome ( RDS ) in 128 premature human infants . There was a significant reduction ( P<0.05 ) in the incidence of RDS in the betamethasone-treated infants to 8.7 % compared to an incidence of 22.6 % in the saline-treated controls and 25.0 % in infants whose mothers received methylprednisolone . The effectiveness of betamethasone in reducing RDS was limited to premature infants delivered to mothers with intact fetal membranes and with an initial L/S ratio less than 2.0 . The time between administration of the glucocorticoid and delivery did not significantly affect the incidence of RDS in this study . The failure of methylprednisolone to reduce the development of RDS in premature infants suggests its potential use in maternal therapy during pregnancy with minimal effects on fetal maturation The objective of the series was to study the effect of prenatal dexamethasone therapy on the growth and neurological development of preterm children until the age of 2 years . Eighty‐two children with a mean gestational age of 30 ( 24–33 ) weeks and a mean weight of 1291 ( 530–2360 ) g at birth , treated antenatally with either dexamethasone ( n= 50 ) or placebo ( n= 32 ) , were examined at the adjusted age of 24 months by a paediatric neurologist , a neuropsychologist and a speech therapist . Neurological development was defined as normal if all scores of neuropaediatric , neuropsychological and verbal tests were within the normal range . Normal neurological development was found in 52 % of the dexamethasone‐treated and in 34 % of the placebo‐treated children . The incidence of cerebral palsy was 10 % in the dexamethasone group and 22 % in the placebo group . Minor developmental delay was found in 42 % of dexamethasone‐treated and in 53 % of placebo‐treated children . Our follow‐up results indicate that the beneficial effect of prenatal glucocorticoid treatment on cerebral complications I intraventricular haemorrhage or periventricular leucomalacia ) demonstrated during the neonatal period may be followed by a lower incidence of cerebral palsy in surviving premature children Objective To assess the efectiveness of corticosteroids in patients with preterm premature rupture of membranes ( PROM ) after treatment with a broad-spectrum antibiotic , ampicillin-sulbactam . Methods A r and omized clinical trial of corticosteroids in patients with preterm PROM was undertaken after treating these patients for a minimum of 12 hours with ampicillin-sulbactam . No digital vaginal examinations were performed on these patients . Antbiotics were continued for 7 days and the steroids were repeated weekly . No tocolytics were used . The primary outcome measure was the incidence of respiratory distress syndrome ( RDS ) . Secondary outcome measures included latency period and neonatal and maternal infectious morbidity . Results Seventy-seven patients were enrolled and data about their pregnancies were analyzed . No statistically significant difference in latency period was noted ( 14.7 days in the steroid group , 15.8 days in the no-steroid group ) . Both neonatal and maternal infectious morbidity were similar . A significant reduction in the incidence of RDS ( 18.4 versus 43.6 % , P = .03 ) were observed in the steroid group . Conclusion These data suggest that treating preterm PROM patients with a broad-spectrum antibiotic before corticosteroids decreases RDS without apparent adverse sequelae BACKGROUND Infants who are born at 34 to 36 weeks of gestation ( late preterm ) are at greater risk for adverse respiratory and other outcomes than those born at 37 weeks of gestation or later . It is not known whether betamethasone administered to women at risk for late preterm delivery decreases the risks of neonatal morbidities . METHODS We conducted a multicenter , r and omized trial involving women with a singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation who were at high risk for delivery during the late preterm period ( up to 36 weeks 6 days ) . The participants were assigned to receive two injections of betamethasone or matching placebo 24 hours apart . The primary outcome was a neonatal composite of treatment in the first 72 hours ( the use of continuous positive airway pressure or high-flow nasal cannula for at least 2 hours , supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 4 hours , extracorporeal membrane oxygenation , or mechanical ventilation ) or stillbirth or neonatal death within 72 hours after delivery . RESULTS The primary outcome occurred in 165 of 1427 infants ( 11.6 % ) in the betamethasone group and 202 of 1400 ( 14.4 % ) in the placebo group ( relative risk in the betamethasone group , 0.80 ; 95 % confidence interval [ CI ] , 0.66 to 0.97 ; P=0.02 ) . Severe respiratory complications , transient tachypnea of the newborn , surfactant use , and bronchopulmonary dysplasia also occurred significantly less frequently in the betamethasone group . There were no significant between-group differences in the incidence of chorioamnionitis or neonatal sepsis . Neonatal hypoglycemia was more common in the betamethasone group than in the placebo group ( 24.0 % vs. 15.0 % ; relative risk , 1.60 ; 95 % CI , 1.37 to 1.87 ; P<0.001 ) . CONCLUSIONS Administration of betamethasone to women at risk for late preterm delivery significantly reduced the rate of neonatal respiratory complications . ( Funded by the National Heart , Lung , and Blood Institute and the Eunice Kennedy Shriver National Institute of Child Health and Human Development ; Clinical Trials.gov number , NCT01222247 . ) Antenatal steroid therapy reduces the incidence of respiratory distress syndrome ( RDS ) in premature infants . However , animal studies showed a decrease in lung cell number and lower lung weights in fetal rabbits exposed to hydrocortisone . This prompted us to measure flows and lung volumes ( by spirometry and helium-dilution method ) in children greater than 6 years who were part of a study by the Collaborative Group on Antenatal Steroid Therapy . The effect of antenatal steroids on subsequent pulmonary function had not previously been studied . Of the 158 children originally enrolled before birth , a total of 8 dexamethasone (DEX)- and 11 placebo-treated children were still local residents and fulfilled the criteria of the study ( gestational age , 28 - 34 weeks ; DEX/placebo treatment 1 - 7 days before delivery ) . Mean heights and weights were normal with no significant differences between the groups . Pulmonary function tests showed no differences in lung volumes or expiratory flows between the children whose mothers had received antenatal DEX and those who had received placebo . These results indicate no adverse effect of antenatal DEX on subsequent lung volumes and expiratory flows in childhood Potential side effects of antenatal administration of corticosteroids to prevent neonatal respiratory distress syndrome were studied in 10- to 12-year-old children whose mothers had participated in a r and omized , double-blind , placebo-controlled trial of betamethasone . The children had a general physical examination ; parents were interviewed about the medical history of their child with special attention to infectious diseases ; growth data were collected ; and a developmental neurological examination , an ophthalmological examination , and a lung function test were conducted . In the corticosteroid group significantly more hospital admissions because of infectious diseases during the first years of life were reported . On the other variables no differences between the corticoid and the placebo groups were found OBJECTIVE To study late side effects of antenatal corticosteroid treatment on health and sexual development in subjects 20 to 22 years old . METHODS A follow-up study among young adults whose mothers had , because of a threatening delivery , participated in a r and omized , double-blind , placebo- controlled trial of betamethasone to prevent neonatal respiratory distress syndrome . Measurements were taken on general health , growth , development in puberty , reproductivity , genital or gynecological complaints , gender development , sexual orientation , sex-specific cognitive functioning , and psychoneuroticism . In addition , some measurements were performed on family diseases , socioeconomic status , and education . RESULTS No differences were found between the corticosteroid-treated and placebo groups as to medical or psychological variables . In general , the subjects were healthy and had normal intellectual capacities . Groups did not differ on gender development , sexual orientation , sex-specific cognitive functioning , and psychoneuroticism . Systolic blood pressure was significantly lower in the corticosteroid group , but the groups did not differ as to diastolic blood pressure . CONCLUSIONS Our 20-year follow-up study indicates that 1 course of antenatally administered corticosteroid to prevent respiratory distress syndrome does not have adverse effects up to adulthood A prospect i ve double-blind r and omized clinical trial was carried out to determine whether glucocorticoid treatment reduces the risk of respiratory distress syndrome ( RDS ) in prematurely born infants . There were 127 infants born to 122 mothers who received either steroid ( dexamethasone phosphate ) or placebo . No differences between groups occurred in risk factors for RDS ( eg , prepartum asphyxia , male sex , cesarean section ) . When those who received a full course of dexamethasone therapy were compared with those who received placebo , a significant reduction was found in risk , severity , and deaths due to RDS . An increased incidence of infection in mothers treated with steroid was evident , particularly after premature rupture of membranes . We conclude that steroids are effective in reducing risk of RDS , but safer and more efficacious approaches for the prevention of RDS should be sought In a large multicentered , collaborative r and omized and blinded trial utilizing antenatal corticosteroids , the goals included determining the effectiveness of these agents in accelerating lung maturation , as well as monitoring any short-term or long-term adverse effects of this treatment on the parturient , fetus , and /or infant . More than 100 specific items , pertaining to diagnoses , complications , and outcomes were recorded for the 696 mothers enrolled in the study and their 745 infants . A significantly decreased incidence of necrotizing enterocolitis ( P = .002 ) was found in the infants treated with steroids . The possibility of accelerated intestinal maturation induced by antenatal maternal steroid therapy exists . This treatment regimen is particularly attractive as adverse aspects of steroid therapy at the dosage utilized have not been demonstrated In a prospect i ve , r and omized , double‐blind , multicentre trial the effect of antenatal treatment with betamethasone phosphate was compared with placebo in the prevention of
Output:
| No increased risk in maternal death was observed .
Evidence from this up date supports the continued use of a single course of antenatal corticosteroids to accelerate fetal lung maturation in women at risk of preterm birth .
A single course of antenatal corticosteroids could be considered routine for preterm delivery . |
MS213117 | ***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 our prospect i ve , controlled study was to determine whether providing the results of a psychiatric screening instrument , the General Health Question naire ( GHQ ) , to emergency physicians would result in a change in the detection and management of patients with psychosocial problems . Five hundred ninety-nine emergency department patients were enrolled , 242 in the control and 357 in the intervention group . Noncritical patients , selected by presenting complaint , were given the GHQ to complete before physician evaluation ; those whose GHQ scores were high ( 10 or higher ) were identified as having a greater likelihood of having psychosocial problems . During the intervention phase , physicians were provided the patient 's GHQ score before beginning their evaluation , as well as a specific mechanism for psychosocial referral . A significantly greater proportion of patients with high GHQ scores in both study groups were judged by physicians to have a psychiatric problem ( P less than .0001 ) . During the intervention phase , patients with high scores more frequently were assigned a psychiatric diagnosis ( 14.1 % vs 7.7 % ) and received psychosocial referral ( 36.1 % vs 5.7 % ) . However , only the latter difference was statistically significant ( P less than .0001 ) . The majority ( 85.7 % ) of patients offered psychosocial referral accepted their referral . There was no difference in the number of laboratory tests ordered or medical/surgical referrals requested between patients in the control or intervention groups with high scores . Therefore , providing GHQ results to emergency physicians led to more frequent psychiatric diagnoses and psychosocial referrals of patients with high GHQ scores but did not alter their medical management The objective was to assess the potential benefits of the routine use of the MOS SF-36 Health Survey ( SF-36 ) in the care of ambulatory patients . The design was a longitudinal , prospect i ve , r and omized , controlled study set in the outpatient neurology clinic at the New Engl and Medical Center . There were 163 consecutive patients with epilepsy who had 210 follow-up visits with one of two epileptologists . The patients completed the SF-36 before the patient-physician encounter and the forms were optically scanned . The SF-36 results of the intervention group patients were given to the physicians before the encounter and withheld for control group patients . For intervention group patients , the physicians completed a question naire assessing the impact of the SF-36 on the process of care . After the visit , all patients completed a satisfaction question naire . The main outcome measures were the physicians ' responses to st and ardized questions about the usefulness of the SF-36 for communication with and management of epilepsy patients and the patients ' responses to st and ardized questions about their satisfaction with care . The physicians indicated that the SF-36 provided new information in 63 % of the intervention group encounters . A change in therapy was prompted in 13 % . The physicians rated the SF-36 as at least moderately useful for communication in 14 % of the encounters and to management in 8 % . The lower ( indicating worse health status ) the patients ' SF-36 scale scores , the more useful the SF-36 results were rated by the physicians for communication and management . It was concluded that the routine use of health status measures may enhance patients ' care This study was design ed to test the short-term effects of health assessment on the process of care and patient satisfaction . The 29 Chart physicians used the Dartmouth COOP Charts to measure their adult patients ' health status during a single clinical encounter ; the 27 control clinicians used no measure of health status . We compared the change between baseline and post-intervention information for a sample of all study clinicians ' patients . Most of the patients were female ( 67 % ) , well educated ( 70 % had at least a college education ) and young ( approximately 90 % were aged 59 years or younger ) . We found that the ordering of tests and procedures for women was increased by exposure to the COOP Charts ( 52 % vs. 35 % ; p<0.01 ) ; the effect in men was not as significant ( 37 % vs. 23 % : p=0.06 ) . Although women reported no change in satisfaction with care , men cl aim ed that the clinician helped in the management of pain ( p=0.02 ) . We conclude that the use of health status measures during a single clinical encounter in an HMO changes clinician test ordering behaviour and may improve the help male patients receive for pain conditions . The long-term impact of these management changes is not known Objectives : To measure the prevalence of high scores on the Geriatric Depression Scale in an inpatient unit for older people and assess whether administration of this instrument increased the use of antidepressant medication . Design : R and omized controlled trial . Setting : Inpatient unit for assessment , treatment and rehabilitation of older adults in a district hospital . Subjects : Consecutive admissions to the inpatient unit were approached . Of 198 people , 100 gave consent and were r and omized to receive the intervention . Interventions : The Geriatric Depression Scale and the Folstein Mini-mental State Examination were administered to the intervention group . The Nottingham Instrumental Activities of Daily Living question naire and the Folstein Mini-mental State Examination were administered to the placebo group . The scores of these instruments and a copy of the completed instrument were placed in the subject 's case notes . For those subjects r and omized to receive the Geriatric Depression Scale an interpretation of the score was written in the case notes . Main outcome measures : The primary outcome measure was whether antidepressant medication was listed on the discharge summary for the admission . Other outcome measures were death , readmission and use of antidepressant medication three months after administration of the instruments . Results : There was a prevalence of Geriatric Depression Scale scores greater than 10 of 52 % in the 50 people administered this instrument . Six out of 46 people administered the Geriatric Depression Scale , who were discharged in the study period , were on antidepressant medication at discharge . Three out of 47 people administered the placebo instrument were on antidepressant medication at discharge . The absolute difference in proportions was 6.7 % , 95 % confidence interval 19 to – 5.3 % . Conclusions : A high proportion of patients admitted to an inpatient unit for assessment , treatment and rehabilitation scored in the depressed range on the Geriatric Depression Scale ; however , use of the Geriatric Depression Scale in this clinical setting did not increase the use of antidepressant medication . This may be because the instrument is too nonspecific The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas OBJECTIVE A r and omized controlled trial was conducted to examine the clinical effectiveness of providing general practitioners ( GPs ) with the results of a self-administered computerized assessment of common mental disorders . METHOD Attenders at a general practice in a deprived inner city area of South London were identified using case finding question naires . Six hundred and eighty-one subjects were r and omly allocated to three groups which differed in the information provided to the GP : 1 ) no additional information was given to the GP ; 2 ) the results of the 12 item General Health Question naire ( GHQ ) were given to the GP ( the GHQ is a paper and pencil question naire that assesses common mental disorders ) ; 3 ) the results of a self-administered computerized assessment ( PROQSY ) of common mental disorders were provided for the GP . RESULTS Clinical outcome was assessed using the 12-item GHQ . Consultations with the GP , prescriptions and referrals within and outside the practice were also recorded . The group in whom the GP received the results of the computerized assessment showed a modest clinical improvement , relative to the other two groups after 6 weeks . There was no difference in clinical outcome between the groups at 6 months . There appeared to be no increase in consultations or prescriptions in the computerized assessment group . CONCLUSIONS Self-administered computerized assessment s for psychiatric disorder have potential as a means of improving the clinical outcome of patients in primary care . It is likely that the effectiveness of the approach would be greatly increased by linking the results of computerized assessment s to clinical practice guidelines , tailored to the individual patient by means of computerized technology OBJECTIVE : To improve functional status among primary care patients .INTERVENTION : 1 ) Computer-generated feedback to physicians about the patient ’s functional status , the patient ’s self-reported “ chief complaint , ” and problem-specific re source and management suggestions ; and 2 ) two brief interactive educational sessions for physicians . DESIGN : R and omized controlled trial . SETTING : University primary care clinic . PARTICIPANTS : All 73 internal medicine houseofficers and 557 of their new primary care patients . MEASURES : 1 ) Change in patient functional status from enrollment until six months later , using the Functional Status Question naire ( FSQ ) ; 2 ) management plans and additional information about functional status abstract ed from the medical record ; and 3 ) physician attitude about whether internists should address functional status problems . RESULTS : Emotional well-being scores improved significantly for the patients of the experimental group physicians compared with those of the control group physicians ( p<0.03 ) . Limitations in social activities indicated as “ due to health ” decreased among the elderly ( > 70 years of age ) individuals in the experimental group compared with the control group ( p<0.03 ) . The experimental group physicians diagnosed more symptoms of stress or anxiety than did the control group physicians ( p<0.001 ) and took more actions recommended by the feedback form ( p<0.02 ) . CONCLUSIONS : Computer-generated feedback of functional status screening results accompanied by re source and management suggestions can increase physician diagnoses of impaired emotional well-being , can influence physician management of functional status problems , and can assist physicians in improving emotional well-being and social functioning among their patients OBJECTIVE : To describe primary care physicians ’ clinical decision making regarding late-life depression . DESIGN : Longitudinal collection of data regarding physicians ’ clinical assessment s and the volume and content of patients ’ ambulatory visits as part of a r and omized clinical trial of a physician-targeted intervention to improve the treatment of late-life depression . SETTING : Academic primary care group practice . PATIENTS / PARTICIPANTS : One-hundred and eleven primary care physicians who completed a structured question naire to describe their clinical assessment s immediately following their evaluations of 222 elderly patients who had reported symptoms of depression on screening question naires . EVTERVENTIONS : Intervention physicians were provided with their patient ’s score on the Hamilton Depression rating scale ( HAM-D ) and patient-specific treatment recommendations prior to completing the question naire regarding their clinical assessment .MAIN RESULTS : Those physicians not provided HAM-D scores were just as likely to rate their patients as depressed , as determined by specific query of these physicians regarding their clinical assessment s. A physician ’s clinical rating of likely depression did not consistently result in the formulation of treatment intentions or actions . Treatment intentions and actions were facilitated by provision of treatment algorithms , but treatment was received by fewer than half of the patients whom physicians intended to treat . Barriers to treatment appear to include both physician and patient doubts about treatment benefits . CONCLUSIONS : Lack of recognition of depressive symptoms did not appear to be the primary barrier to treatment . Recognition of symptoms and access to treatment algorithms did not consistently result in progression to subsequent stages in treatment decision making . More research is needed to determine how patients and physicians weigh the potential risks and benefits of treatment and how accurately they make these judgments The study assessed the effect of screening for mental disorder by means of the General Health Question naire ( GHQ ) on the rate of detection of mental disorder by fourteen physicians in a primary -care clinic . After completing the GHQ , patients were r and omised into control ( 722 patients ) and experimental ( 730 patients ) groups . GHQ results of the experimental group were made available to the physicians ; those of the control group were not . Sociodemographic factors influenced the physicians ' rate of diagnosis of mental disorders ( rates were lower for men , students , and patients with at least a partial college education than in subjects who had a low income , less than 7 years of school , or were widowed ) but there was no difference between control and experimental groups ( 16.8 % vs 16.0 % ) . Among patients with a prior diagnosis of a mental disorder , twice as many were found to have mental disorders by the physicians as by the GHQ ( 70 % vs 33 % ) CONTEXT Care of patients with depression in managed primary care setting s often fails to meet guideline st and ards , but the long-term impact of quality improvement ( QI ) programs for depression care in such setting s is unknown . OBJECTIVE To determine if QI programs in managed care practice s for depressed primary care patients improve quality of care , health outcomes , and employment . DESIGN R and omized controlled trial initiated from June 1996 to March 1997 . SETTING Forty-six primary care clinics
Output:
| There is substantial evidence that routinely administered case finding/screening question naires for depression have minimal impact on the detection , management or outcome of depression by clinicians . |
MS213118 | ***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 evaluated the motor and sensory block duration s and the postoperative analgesic effects of adding dexmedetomidine to levobupivacaine for sub-Tenon ’s block anesthesia in patients undergoing vitreoretinal surgery . Motor and sensory block duration s were considered as a primary end point . METHODS : Sixty ASA physical status I to III patients subjected to vitreoretinal surgery under sub-Tenon ’s block anesthesia were r and omly divided equally into 2 groups , depending on the local anesthesia solution used , to receive 4 mL of 0.75 % levobupivacaine plus 15 IU hyaluronidase diluted with 1 mL normal saline ( group L ) or 4 mL of 0.75 % levobupivacaine plus 15 IU hyaluronidase and 20 & mgr;g dexmedetomidine diluted with 1 mL normal saline ( group LD ) . The total volume of the local anesthesia solution used was 5 mL. Motor block and sensory block duration s were evaluated until the return of normal motor and sensory functions . The sedation level was assessed during the surgery period and 24 hours postoperatively , together with the degree of postoperative pain . The total diclofenac consumption ( milligrams ) and the number of patients ( % ) who required tramadol were recorded . The sleep quality of the first postoperative night was assessed using the Consensus Sleep Diary . RESULTS : Dexmedetomidine provided significantly longer motor block duration ( 371.90 ± 48.10 vs 264.13 ± 41.48 minutes , P = 0.001 ) and significantly longer sensory block duration ( 499.10 ± 51.76 vs 344.33 ± 45.46 minutes , P = 0.001 ) compared with levobupivacaine alone . Furthermore , the patients in the dexmedetomidine group achieved significantly ( P < 0.0001 ) greater levels of sedation during the surgery period and for 12 hours postoperatively together with significantly ( P < 0.0001 ) lower values of verbal numeric rating scale of pain between the periods from 4 to 12 hours postoperatively compared with the patients in the levobupivacaine group . There was significantly ( P = 0.001 ) less diclofenac consumed ( mg ) in the dexmedetomidine group . The patients in the dexmedetomidine group reported significantly higher rates of good sleep quality on the first postoperative night ( 70 % ) compared with those in the levobupivacaine group ( 30 % ; P < 0.0001 ) . CONCLUSIONS : For patients undergoing vitreoretinal surgery , adding 20 & mgr;g of dexmedetomidine to levobupivacaine for sub-Tenon ’s block anesthesia in vitreoretinal surgery extended the motor and sensory block duration s and provided more effective postoperative analgesia with improvement in the sleep quality in the first postoperative night compared with levobupivacaine alone Background Apha-2 agonists are combined with local anesthetics to extend the duration of regional anesthesia . We evaluated the effect of combining dexmedetomidine with levobupivacine with respect to duration of motor and sensory block and duration of analgesia . Methods Sixty patients scheduled for elective forearm and h and surgery were divided into two equal groups in a r and omized double blind fashion . The patients received brachial plexus block via supraclavicular route with the help of nerve stimulator . In group L ( n=30 ) 35cc of levobupivacaine with 1ml of isotonic saline and in group LD ( n=30 ) 35cc of levobupivacine with 1 ml of ( 100 microgram ) of dexmedetomidine was given . Duration of motor and sensory block and time to first rescue analgesia were recorded . Data analysis was done by SPSS version 16.0 [ SPSS Inc ILLINOIS , USA , 2008 ] . Categorical variables were analyzed using Pearson”s Chi-square test . Normally distributed numerical variables were analyzed using unpaired “ t ” test . Skewed numerical variables within the group were analyzed using Man-Whitney “ U ” test . All tests were two tailed . Statistical significance was defined as P<0.05 . Results Sensory and motor block duration s were longer in group LD as compared to L ( P<0.01 ) . Duration of analgesia was significantly longer in group LD as compared to group L ( p<0.05 ) . Conclusion Dexmedetomidine added to levobupivacaine in supraclavicular brachial plexus block prolongs the duration of block and the duration of postoperative analgesia Background : Perineural and IV dexmedetomidine have each been suggested to prolong the duration of analgesia when administered in conjunction with peripheral nerve blocks . In the first r and omized , triple-masked , placebo-controlled trial to date , the authors aim ed to define and compare the efficacy of perineural and IV dexmedetomidine in prolonging the analgesic duration of single-injection interscalene brachial plexus block ( ISB ) for outpatient shoulder surgery . Methods : Ninety-nine patients were r and omized to receive ISB using 15 ml ropivacaine , 0.5 % , with 0.5 & mgr;g/kg dexmedetomidine administered perineurally ( DexP group ) , intravenously ( DexIV group ) , or none ( control group ) . The authors sequentially tested the joint hypothesis that dexmedetomidine prolongs the duration of analgesia and reduces the 24-h cumulative postoperative morphine consumption . Motor blockade , pain severity , hemodynamic variations , opioid-related side effects , postoperative neurologic symptoms , and patient satisfaction were also evaluated . Results : Ninety-nine patients were analyzed . The duration of analgesia was 10.9 h ( 10.0 to 11.8 h ) and 9.8 h ( 9.0 to 10.6 h ) for the DexP and DexIV groups , respectively , compared with 6.7 h ( 5.6 to 7.8 ) for the control group ( P < 0.001 ) . Dexmedetomidine also reduced the 24-h cumulative morphine consumption to 63.9 mg ( 58.8 to 69.0 mg ) and 66.2 mg ( 60.6 to 71.8 mg ) for the DexP and DexIV groups , respectively , compared with 81.9 mg ( 75.0 to 88.9 mg ) for the control group ( P < 0.001 ) . DexIV was noninferior to DexP for these outcomes . Both dexmedetomidine routes reduced the pain and opioid consumption up to 8 h postoperatively and did not prolong the duration of motor blockade . Conclusion : Both perineural and IV dexmedetomidine can effectively prolong the ISB analgesic duration and reduce the opioid consumption without prolonging motor blockade Aims and Objectives : Supplementation of dexmedetomidine produces a dose-dependent sedation , anxiolysis and analgesia without respiratory depression . This study was conducted to evaluate the possible effect of dexmedetomidine as an adjuvant to levobupivacaine for supraclavicular brachial plexus block in upper limb surgery . Setting s and Design : Tertiary care institute , Department of Anaesthesiology and Intensive Care , a placebo-controlled study . Material s and Methods : After obtaining Ethical Committee approval , a r and omized , double-blind , placebo-controlled study was conducted on sixty American Society of Anesthesiologists physical status I and II patients in the age group of 18–60 years , divided r and omly into two groups , Group I received 30 ml of 0.5 % levobupivacaine with 1 ml of isotonic sodium chloride solution and Group II received 30 ml of 0.5 % levobupivacaine and 1 ml ( 100 mcg ) of dexmedetomidine for supraclavicular brachial plexus block . The onset and duration of sensory and motor blockade , duration of analgesia ( DOA ) and any adverse effects were noted . At the end of the study , data were compiled and analyzed using appropriate statistical tests . The value of P < 0.05 was considered significant . Results : Demographic profile was comparable in both the groups . The time to onset of sensory and motor block was 10.54 ± 2.333 min and 12.21 ± 2.529 min in Group I while it was 3.24 ± 0.951 min and 2.83 ± 1.197 min in Group II , respectively . The duration of sensory and motor block was 7.79 ± 2.007 h and 9.18 ± 1.701 h in Group I , and it was 16.31 ± 2.606 h and 17.52 ± 2.098 h in Group II , respectively . The DOA was 678.68 ± 20.492 min in Group I and 1273.79 ± 83.139 min in Group II . On statistical comparison , these values were highly significant ( P < 0.001 ) . Side effects such as nausea , vomiting , hypoxemia , pruritis , or urinary retention were not observed in either of the groups . Conclusion : Dexmedetomidine shortens the onset time for sensory and motor block significantly and prolongs DOA as well when used with levobupivacaine for supraclavicular brachial plexus block , without increasing the incidence of any adverse effects BACKGROUND There is little systematic research on the efficacy and tolerability of the addition of adjunctive analgesic agents in paravertebral analgesia . The addition of adjunctive analgesics , such as fentanyl and clonidine , to local anesthetics has been shown to enhance the quality and duration of sensory neural blockades , and decrease the dose of local anesthetic and supplemental analgesia . OBJECTIVES Investigation of the safety and the analgesic efficacy of adding 1 μg/kg dexmedetomidine to bupivacaine 0.25 % in thoracic paravertebral blocks ( PVB ) in patients undergoing modified radical mastectomy . STUDY DESIGN A r and omized , double-blind trial . SETTING Academic medical center . METHODS Sixty American Society of Anesthesiologists physical status -I - III patients were r and omly assigned to receive thoracicPVB with either 20 mL of bupivacaine 0.25 % ( Group B , n = 30 ) , or 20 mL of bupivacaine 0.25 % + 1 μg/kg dexmedetomidine ( Group BD , n= 30 ) . Assessment parameters included hemodynamics , sedation score , pain severity , time of first analgesics request , total analgesic consumption , and side effects in the first 48 hours . RESULTS There was a significant reduction in pulse rate and diastolic blood pressure starting at 30 minutes in both groups , but more evidence d in group BD ( P < 0.001 ) . Intraoperative Systolic blood pressure showed a significant reduction at 30 minutes in both groups ( P < 0.001 ) then returned to baseline level at 120 minutes in both groups . There was a significant increase in pulse rate starting 2 hours postoperative until 48 hours postoperatively in group B but only after 12 hours until 48 hours in group BD ( P < 0.001 ) . The time of the first rescue analgesic requirement was significantly prolonged in the group BD ( 8.16 ± 42 hours ) in comparison to group B ( 6.48 ± 5.24 hours ) ( P = 0.04 ) . The mean total consumption of intravenous tramadol rescue analgesia in the postanesthesia care unit in the firtst 48 hours postoperatively was significantly decreased in group BD ( 150.19 ± 76.98 mg ) compared to group B ( 194.44 ± 63.91 mg ) ( P = 0.03 ) . No significant serious adverse effects were recorded during the study . LIMITATIONS This study is limited by its sample size . CONCLUSION The addition of dexmedetomidine 1 μg/kg to bupivacaine 0.25 % in thoracic PVB in patients undergoing modified radical mastectomy improves the quality and the duration of analgesia and also provides an analgesic sparing effect with no serious side effects This week , a series of four articles considers the place of the r and omised controlled trial as we approach the second century of experience with the concept . Its basic principle is genuine uncertainty as to which treatment arm of the trial it would be in a patient 's best interests to enter . This is not necessarily an easy concept to transmit , Background and Aims : Different additives have been used to prolong brachial plexus block . We evaluated the effect of adding dexmedetomidine to ropivacaine for supraclavicular brachial plexus blockade . The primary endpoints were the onset and duration of sensory and motor block and duration of analgesia . Material s and Methods : A total of 84 patients ( 20 - 50 years ) posted for elective forearm and h and surgery under supraclavicular brachial plexus block were divided into two equal groups ( Group R and RD ) in a r and omized , double-blind fashion . In group RD ( n = 42 ) 30 ml 0.
Output:
| This meta- analysis demonstrated that DEX in combination with local anaesthetics increases postoperative analgesia for around 5 h. However , there are higher risks of intraoperative hypotension and bradycardia .
Initial evidence suggests no difference in the duration of analgesia associated with systemic or perineural DEX . |
MS213119 | ***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 research on schizophrenia indicates that cognitive deficits in this illness are important predictors of functional outcome , highlighting the need for treatments that have a positive impact on cognitive function . Here we explore the hypothesis that acute administration of d-amphetamine can improve cognitive function in individuals with schizophrenia who are well-treated with typical antipsychotics , as well as in healthy controls performing under dual task conditions design ed to elicit performance deficits analogous to those found in schizophrenia . METHODS Ten individuals with schizophrenia taking haldol or prolixin and 22 healthy controls performed spatial working memory , language production , and Stroop tasks under both placebo and 0.25 mg/kg of D-amphetamine . RESULTS D-Amphetamine improved reactions times on the spatial working memory and Stroop tasks for both individuals with schizophrenia and controls , and improved working memory accuracy in schizophrenia . In addition , D-amphetamine improved language production for both individuals with schizophrenia and controls . CONCLUSIONS These results provide support for the hypothesis that the adjunctive administration of dopamine agonist can improve cognitive in individuals with schizophrenia taking typical antipsychotics . The results are discussed in terms of their implication s for underst and ing the nature of working memory deficits in schizophrenia , and potential future avenues for cognitive enhancement in this illness OBJECTIVE Despite a prevailing assumption that adult ADHD is a childhood-onset neurodevelopmental disorder , no prospect i ve longitudinal study has described the childhoods of the adult ADHD population . The authors report follow-back analyses of ADHD cases diagnosed in adulthood , alongside follow-forward analyses of ADHD cases diagnosed in childhood , in one cohort . METHOD Participants belonged to a representative birth cohort of 1,037 individuals born in Dunedin , New Zeal and , in 1972 and 1973 and followed to age 38 , with 95 % retention . Symptoms of ADHD , associated clinical features , comorbid disorders , neuropsychological deficits , genome-wide association study -derived polygenic risk , and life impairment indicators were assessed . Data sources were participants , parents , teachers , informants , neuropsychological test results , and administrative records . Adult ADHD diagnoses used DSM-5 criteria , apart from onset age and cross- setting corroboration , which were study outcome measures . RESULTS As expected , childhood ADHD had a prevalence of 6 % ( predominantly male ) and was associated with childhood comorbid disorders , neurocognitive deficits , polygenic risk , and residual adult life impairment . Also as expected , adult ADHD had a prevalence of 3 % ( gender balanced ) and was associated with adult substance dependence , adult life impairment , and treatment contact . Unexpectedly , the childhood ADHD and adult ADHD groups comprised virtually nonoverlapping sets ; 90 % of adult ADHD cases lacked a history of childhood ADHD . Also unexpectedly , the adult ADHD group did not show tested neuropsychological deficits in childhood or adulthood , nor did they show polygenic risk for childhood ADHD . CONCLUSIONS The findings raise the possibility that adults presenting with the ADHD symptom picture may not have a childhood-onset neurodevelopmental disorder . If this finding is replicated , then the disorder 's place in the classification system must be reconsidered , and research must investigate the etiology of adult ADHD IMPORTANCE Attention-deficit/hyperactivity disorder ( ADHD ) is now recognized to occur in adulthood and is associated with a range of negative outcomes . However , less is known about the prospect i ve course of ADHD into adulthood , the risk factors for its persistence , and the possibility of its emergence in young adulthood in non clinical population s. OBJECTIVE To investigate childhood risk factors and young adult functioning of individuals with persistent , remitted , and late-onset young adult ADHD . DESIGN , SETTING , AND PARTICIPANTS The study sample was the Environmental Risk ( E-Risk ) Longitudinal Twin Study , a nationally representative birth cohort of 2232 twins born in Engl and and Wales from January 1 , 1994 , to December 4 , 1995 . Evaluation of childhood ADHD ( ages 5 , 7 , 10 , and 12 years ) included prenatal and perinatal factors , clinical characteristics , and aspects of the family environment . Among participants aged 18 years , ADHD symptoms and associated impairment , overall functioning , and other mental health disorders were examined . Data analysis was conducted from February 19 to September 10 , 2015 . MAIN OUTCOMES AND MEASURES Attention-deficit/hyperactivity disorder according to DSM-IV diagnostic criteria in childhood and DSM-5 diagnostic criteria in young adulthood . RESULTS Of 2232 participants in the E-Risk Study , 2040 were included in the present analysis . In total , 247 individuals met diagnostic criteria for childhood ADHD ; of these , 54 ( 21.9 % ) also met diagnostic criteria for the disorder at age 18 years . Persistence was associated with more symptoms ( odds ratio [ OR ] , 1.11 [ 95 % CI , 1.04 - 1.19 ] ) and lower IQ ( OR , 0.98 [ 95 % CI , 0.95 - 1.00 ] ) . At age 18 years , individuals with persistent ADHD had more functional impairment ( school/work : OR , 3.30 [ 95 % CI , 2.18 - 5.00 ] , home/with friends : OR , 6.26 [ 95 % CI , 3.07 - 12.76 ] ) , generalized anxiety disorder ( OR , 5.19 [ 95 % CI , 2.01 - 13.38 ] ) , conduct disorder ( OR , 2.03 [ 95 % CI , 1.03 - 3.99 ] ) , and marijuana dependence ( OR , 2.88 [ 95 % CI , 1.07 - 7.71 ] ) compared with those whose ADHD remitted . Among 166 individuals with adult ADHD , 112 ( 67.5 % ) did not meet criteria for ADHD at any assessment in childhood . Results from logistic regressions indicated that individuals with late-onset ADHD showed fewer externalizing problems ( OR , 0.93 [ 95 % CI , 0.91 - 0.96 ] ) and higher IQ ( OR , 1.04 [ 95 % CI , 1.02 - 1.07 ] ) in childhood compared with the persistent group . However , at age 18 years , those with late-onset ADHD demonstrated comparable ADHD symptoms and impairment as well as similarly elevated rates of mental health disorders . CONCLUSIONS AND RELEVANCE We identified heterogeneity in the DSM-5 young adult ADHD population such that this group consisted of a large , late-onset ADHD group with no childhood diagnosis , and a smaller group with persistent ADHD . The extent to which childhood-onset and late-onset adult ADHD may reflect different causes has implication s for genetic studies and treatment of ADHD PURPOSE To estimate the risk of schizophrenia in adulthood among children and adolescents with ADHD compared to the background population . SUBJECTS/ MATERIAL S AND METHODS Two hundred and eight youths with ADHD ( 183 boys ; 25 girls ) were followed prospect ively . Diagnoses of schizophrenia were obtained from The Danish Psychiatric Central Register . The relative risk ( RR ) of schizophrenia for cases with ADHD , compared to the normal population , was calculated as risk ratios . Hazard ratios ( HR 's ) by Cox regression were calculated in the predictor analyses . RESULTS Mean age for ADHD cases at follow-up was 31.1years . Schizophrenia diagnoses were given to 3.8 % of these cases . Compared to the general population , RR of schizophrenia in cases with ADHD was 4.3 ( 95 % CI 1.9 - 8.57 ) . DISCUSSION AND CONCLUSION This prospect i ve follow-up study found children with ADHD to be at higher risk of later schizophrenia than controls . If replicated , these results warrant increased focus on the possible emergence symptoms of schizophrenia or schizophreniform psychosis during clinical follow-up of patients with ADHD The goal of this study was to investigate the characteristics of schizophrenic patients with a history of childhood attention deficit hyperactivity disorder ( ADHD ) . The study was performed on 37 adolescent patients meeting the DSM-III-R criteria for schizophrenia and ADHD and 40 controls with schizophrenia only . Schizophrenic patients who were diagnosed in childhood as suffering from ADHD had more prominent developmental disturbances in infancy , more insidious course of schizophrenia , failed to respond to neuroleptics and had poorer outcome as compared to patients with schizophrenia only . The results of this study indicate that schizophrenia subsequent to childhood ADHD has a poor prognosis as compared to schizophrenia only
Output:
| Conclusions We demonstrate a greater presence of ADHD symptomatology in SCZ compared to that reported for ADHD in the general population . |
MS213120 | ***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 Seroma is a virtually unavoidable early sequela after TEP hernioplasty . This r and omised controlled trial evaluated the outcomes of preperitoneal closed-system suction drainage in laparoscopic totally extraperitoneal ( TEP ) hernioplasty for inguinal hernia . Methods Ninety patients aged 18–80 years who presented to our hospital between May 2016 and February 2017 with primary unilateral inguinal hernia were r and omised into the preperitoneal drain and no-drain groups . The primary outcome was seroma size on postoperative day 6 . Secondary outcomes included clinical seroma formation and seroma size on day 1 , day 6 , 1 and 7 months postoperatively , length of postoperative stay , pain score , and recurrence . Results There was no significant difference in age , sex , co-morbidities , hernia side , mean hernia size , operating time , fixation adjuncts , or postoperative stay . The overall incidence of clinical seroma formation was 25.6 % on postoperative day 1 , 60.3 % on postoperative day 6 , 13.2 % 1 month and 0 % 7 months postoperatively . The mean drain output was 57.9 ml . The drain group had significantly fewer patients with seroma on day 1 ( 6 vs 14 , p = 0.022 ) and day 6 ( 17 vs 30 , p = 0.000 ) , and a smaller mean seroma size on days 1 and 6 ( p = 0.000 ) . Subgroup analysis showed that sac ligation versus reduction , peritoneal perforation , and fixation adjuncts had no significant effects on seroma formation or size . There is a trend of lower early post-operation VAS score and more urinary retention in drain group was observed but not reaching statistical significance . No differences in postoperative pain score or complications were observed at 1 and 7 months ’ post operation . Conclusions Preperitoneal drainage for 23 h after laparoscopic TEP hernioplasty for inguinal hernia can effectively decrease seroma formation in the early postoperative period , and potentially improving postoperative pain . The benefit is short-term and no significant difference was demonstrated after 1-month post operations . This tradition technique applied to novel operative repair of inguinal hernia is safe and feasible with no significant morbidity demonstrated . Preperitoneal drainage after TEP can be considered as an option to improve patient satisfactions and recovery in selected patient group for maximal benefit , especially for those with prolonged operation which may associate with higher chance of seroma formation BACKGROUND Massive incarcerated scrotal hernias are usually managed by an open method . Some experienced surgeons have successfully attempted laparoscopic management of such cases . Total extraperitoneal repair ( TEP ) is the laparoscopic technique of choice for the repair of groin hernia . Many authors have suggested that transabdominal preperitoneal ( TAPP ) is the preferred approach to these hernias . The purpose of this study is to show our results of TEP repair of giant scrotal hernias . PATIENTS AND METHODS In the present study a total of 21 ( 20 patients ) out of 291 groin hernias ( 185 patients ) were included and evaluated prospect ively . TEP was successful in 14 ( 66.6 % ) with a conversion to TAPP in 4 ( 19.04 % ) and open procedure in 3 ( 14.28 % ) cases , respectively . Postoperative complications included scrotal hematoma in 5 ( 25 % ) , spermatic cord edema in 6 ( 30 % ) , and seroma in 14 ( 70 % ) patients . There was no recurrence of hernia noticed during mean follow-up of 36 months ( range , 22 - 51 ) . CONCLUSION Laparoscopic TEP repair was successful with excellent outcome in the management of massive incarcerated groin hernia in the h and s of an experienced laparoscopic surgeon Purpose Seroma is among the most common complications of laparoscopic total extraperitoneal ( TEP ) for especially large indirect inguinal hernia , and may be regarded as a recurrence by some patients . A potential area localized behind the mesh and extending from the inguinal cord into the scrotum may be one of the major etiological factors of this complication . Our aim is to describe a novel technique in preventing pseudorecurrence by using fibrin sealant to close that potential dead space . Methods Forty male patients who underwent laparoscopic TEP for indirect inguinal hernia with at least 100-mL volume were included in this prospect i ve clinical study . While fibrin sealant was used to close the potential dead space in the study group , nothing was used in the control group . The volume of postoperative fluid collection on ultrasound was compared between the groups . Results Patient characteristics and the volumes of hernia sac were similar between the 2 groups . The mean volume of postoperative fluid collection was found as 120.2 mL in the control group and 53.7 mL in the study group , indicating a statistical significance ( P < 0.001 ) . Conclusion Minimizing the potential dead space with a fibrin sealant can reduce the amount of postoperative fluid collection , namely the incidence of pseudorecurrence Abstract Introduction : Endoscopic repair was introduced for use with inguinal hernia therapy more than 10 years ago . The technique as well as the indications for this method are debated , however . As a borderline inguinal hernia situation , the scrotal hernia in particular evokes vehement objections to an endoscopic procedure because of the anticipated problems and complications in dissecting the extended hernia sac . The efficiency of the laparoscopic transabdominal preperitoneal ( TAPP ) technique in the treatment of scrotal hernia therefore is discussed in this article . methods : Laparoscopic hernia repair ( TAPP ) has been performed in our department since 1993 . Data are collected by a prospect i ve documentation of operative and follow-up results . For evaluation , a comparison of scrotal and normal hernia repair was performed . Results : Between April 1993 and June 1998 the TAPP technique was used to treat 191 scrotal hernias , 42 ( 22 % ) of which were recurrent hernias . The median operating time for a nomal inguinal hernia repair was 45 min , whereas scrotal hernias required a median of 65 min and irreducible scrotral hernias a median of 68.5 min . Major complications were observed in 1.6 % of scrotal and 0.6 % of normal inguinal hernia repairs . The most frequent scrotal hernia repair problem was the formation of a seroma , 10.5 % of which had to be avacuated . During a follow-up period of 30 months , we found a total of two recurrences ( 1.05 % ) . Conclusion : In scrotal hernia repair , TAPP is not associated with higher complication rates and can be performed with efficiency comparable with that in normal inguinal hernia repair Introduction Seroma is a frequent complication of endoscopic totally extraperitoneal ( TEP ) mesh repair of direct inguinal hernia that may cause discomfort and anxiety . Its volume is proportional to the size of the preperitoneal dead space created after the reduction of the hernia . Attempts to reduce its incidence have included tacking the transversalis fascia ( TF ) to the pubic ramus or closed suction drainage of the preperitoneal space . Both of these techniques are not without problems . The aim of this study was to evaluate the efficiency of a new alternate technique that must be safe and easily reproducible , using a widely available and inexpensive pre-tied suture loop ( Endoloop ® Ligature ) for plication of the weakened TF . Methods This is a prospect i ve study of consecutive patients diagnosed with inguinal hernia during a 33-month period and eligible for endoscopic TEP repair . A single surgeon performed all operations . Each of the M2 or M3 direct defects , according to the European Hernia Society ( EHS ) , were systematic ally closed prior to the introduction of the prosthetic mesh and as follows : grasping and inversion of the attenuated TF at its apex , using a laparoscopic forceps and plication of the TF by placing a tight Endoloop of Polydioxanone ( PDS ) at its base . All meshes were secured with fibrin sealant only . Patients were review ed in the clinic 2 and 6 weeks after the operation . Further follow-up was scheduled if it was deemed necessary . The primary post-operative outcome parameter was seroma formation ; secondary outcome parameters included groin pain , surgical complications , and recurrence . Results Two hundred and fifty hernia repairs were prospect ively recorded during this period . All procedures were carried out endoscopically . Seventy-nine patients with 94 direct inguinal hernias were selected in a sequential manner . There were 75 males and four females , with a median age of 57 years . Of those , 55 were combined with an indirect inguinal defect . In total , Endoloops of PDS were used to close the weakened TF in 76 cases ( 30 M3 , 44 M2 , and two M1 ) . Only one patient ( 1.3 % ) complained of a residual seroma formation , which was still clinical ly present at 3 months post-operatively , but was not symptomatic . There were only two minor post-operative complications , which occurred in the same patient and were not related to the Endoloop technique . Finally , no patient complained of chronic groin pain and there was no hernia recurrence after a median follow-up of 18 months . Conclusions The primary closure of direct inguinal hernia defects with a pre-tied suture loop during endoscopic TEP repair is safe , efficient , and very reliable for the prevention of post-operative seroma formation , without increasing the risk of developing chronic groin pain or hernia recurrence . This technique should be the preferred method over stapling of the TF or the insertion of a closed suction drainage device in such a situation Background : Because it mimics a postoperative recurrence of hernia , seroma has been a concern to patients . There has been no consensus on the management of this condition after endoscopic totally extraperitoneal inguinal hernioplasty ( TEP ) . The objectives of the present study were to evaluate the incidence and treatment of seroma after TEP . Risk factors for the development of seroma were also examined . Methods : A total of 450 consecutive patients who underwent TEP between June 1999 and May 2002 were recruited . All data were collected prospect ively . The outcomes of patients who developed seromas were compared to those without this postoperative complication . Regression analysis was performed to identify independent risk factors for seroma formation . Results : The overall incidence of seroma formation was 7.2 % ( n = 40 ) . The postoperative recovery of patients was not influenced by the development of seroma . The mean size of the seromas was 3.8 cm . Adopted treatment strategies included observation ( n = 29 ) , oral lysozyme ( n = 10 ) , and percutaneous aspiration ( n = 3 ) , but neither of the two interventions appeared to be effective . The seromas resolved spontaneously by an average of 2.4 ( mean ) months . Significant clinical factors associated with seroma formation included old age , large hernial defects , an extension of the hernia into the scrotum , and the presence of a residual distal indirect sac . By logistic regression , a large hernial defect and an extension of the hernia into the scrotum were found to be independent risk factors for seroma formation . Conclusions : Although seroma is a frequent minor morbidity after TEP , it has no impact on postoperative recovery . Because all seromas invariably resolve , expectant treatment with observation is recommended . Inguinoscrotal hernia carries a four-fold increased risk of developing seroma after TEP Purpose Seroma is a frequent postoperative complication after laparoscopic direct inguinal hernia repair ( both in TAPP and TEP ) . There are several methods to address this problem ; however , these techniques are not without problems . The purpose of this study was to introduce and evaluate a new technique to address this problem . Methods This is a prospect i ve study of consecutive patients . All patients diagnosed with direct inguinal hernias eligible for laparoscopic repair were included . A single surgeon performed all the included operations . During laparoscopic inguinal hernia repair ( TAPP or TEP ) , we closed the direct hernia defect with barbed sutures around the transversalis fascia , inverted the apex of the attenuated transversalis fascia , and sutured it at the base to completely eradicate the defect cavity . Prosthetic mesh was not additionally fixed in all patients . The primary postoperative outcome parameter was seroma formation , and secondary outcome parameters included groin pain , surgical complications , and hernia recurrence . Results Twenty-five male patients with 36 sides of direct hernias were included in this study , and all procedures were carried out laparoscopically and successfully . Only one patient developed significant seroma , which resolved 1 month later . The early postoperative pain was minimal , and no recurrence and chronic pain occurred during the follow-up period ( 4–13 months ) . Conclusions The present direct inguinal hernia defect closing technique with barbed suture is a simple , easily reproducible , and effective method for the prevention of seroma formation Abstract Background The seroma generated between the abdominal viscera and the prosthesis ( retroprosthetic seroma ) , after laparoscopic ventral hernia repair ( LVHR ) with the implant of an intraperitoneal mesh is an unknown entity with few references in the literature . Our objective is to analyze its incidence , clinical repercussions and course of retroprosthetic seroma during the first 3 months post-operation and the factors related to its appearance , such as the relationship to preprosthetic seroma , the size of the prosthesis and
Output:
| ConclusionS eroma formation is a natural process that can not be completely prevented following laparoscopic inguinal hernioplasty , especially in patients with direct and large indirect inguinal hernias .
Some intraoperative adjunctive techniques are effective in reducing clinical ly palpable seroma formation in select patients . |
MS213121 | ***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 R and omized efficacy clinical trials conducted in research setting s may not accurately reflect the benefits of tobacco dependence treatments when used in real-world clinical setting s. Effectiveness trials ( eg , in primary care setting s ) are needed to estimate the benefits of cessation treatments in real-world use . METHODS A total of 1346 primary care patients attending routine appointments were recruited by medical assistants in 12 primary care clinics . Patients were r and omly assigned to 5 active pharmacotherapies : 3 monotherapies ( nicotine patch , nicotine lozenge , and bupropion hydrochloride sustained release [ SR ] ) and 2 combination therapies ( patch + lozenge and bupropion SR + lozenge ) . Patients were referred to a telephone quit line for cessation counseling . Primary outcomes included 7-day point prevalence abstinence at 1 week , 8 weeks , and 6 months after quitting and number of days to relapse . RESULTS Among 7128 eligible smokers ( > or = 10 cigarettes per day ) attending routine primary care appointments , 1346 ( 18.9 % ) were enrolled in the study . Six-month abstinence rates for the 5 active pharmacotherapies were the following : bupropion SR , 16.8 % ; lozenge , 19.9 % ; patch , 17.7 % ; patch + lozenge , 26.9 % ; and bupropion SR + lozenge , 29.9 % . Bupropion SR + lozenge was superior to all of the monotherapies ( odds ratio , 0.46 - 0.56 ) ; patch + lozenge was superior to patch and bupropion monotherapies ( odds ratio , 0.56 and 0.54 , respectively ) . CONCLUSIONS One in 5 smokers attending a routine primary care appointment was willing to make a serious quit attempt that included evidence -based counseling and medication . In this comparative effectiveness study of 5 tobacco dependence treatments , combination pharmacotherapy significantly increased abstinence compared with monotherapies . Provision of free cessation medications plus quit line counseling arranged in the primary care setting holds promise for assisting large numbers of smokers to quit . Trial Registration clinical trials.gov Identifier : NCT00296647 AIM To examine changes in nicotine withdrawal , nicotine craving , self-efficacy to quit smoking , and perceived control over withdrawal symptoms as predictors of smoking cessation following behavioral counseling and nicotine replacement therapy in a sample of smokers . DESIGN AND SETTING The data were ascertained from a r and omized effectiveness trial comparing nicotine patch to nicotine lozenge . Predictors of smoking cessation were assessed at baseline and 5 weeks post-baseline , and 24-hour point prevalence abstinence , biochemically confirmed , was assessed at the end-of-treatment ( week 15 ) and 6 months after a target quit date ( week 27 ) . PARTICIPANTS 642 treatment-seeking smokers r and omized to 12 weeks of nicotine patch or nicotine lozenge . FINDINGS Participants who showed a greater increase in self-efficacy to quit smoking ( OR=1.09 , 95 % CI : 1.02 - 1.16 , p=.01 ) and perceived control over withdrawal symptoms ( OR=1.02 , 95 % CI : 1.00 - 1.04 , p=.05 ) were significantly more likely to have quit smoking at week 15 . Participants who showed a greater increase in self-efficacy to quit smoking ( OR=1.04 , 95 % CI : 1.01 - 1.06 , p=.01 ) were significantly more likely to have quit smoking at week 27 . Changes in withdrawal symptoms and craving were not related to week 15 or week 27 abstinence rates . CONCLUSIONS The results highlight two relatively under-studied potential psychological predictors of abstinence following treatment for nicotine dependence . Behavioral counseling interventions to promote smoking cessation should help smokers develop confidence in their ability to quit smoking and increase their sense of control over withdrawal symptoms to increase their chances for cessation IMPORTANCE The US Food and Drug Administration adopted labeling for nicotine patches to allow use beyond the st and ard 8 weeks . This decision was based in part on data showing increased efficacy for 24 weeks of treatment . Few studies have examined whether the use of nicotine patches beyond 24 weeks provides additional therapeutic benefit . OBJECTIVE To compare 8 ( st and ard ) , 24 ( extended ) , and 52 ( maintenance ) weeks of nicotine patch treatment for promoting tobacco abstinence . DESIGN , SETTING , AND PARTICIPANTS We recruited 525 treatment-seeking smokers for a r and omized clinical trial conducted from June 22 , 2009 , through April 15 , 2014 , through 2 universities . INTERVENTIONS Smokers received 12 smoking cessation behavioral counseling sessions and were r and omized to 8 , 24 , or 52 weeks of nicotine patch treatment . MAIN OUTCOMES AND MEASURES The primary outcome was 7-day point prevalence abstinence , confirmed with breath levels of carbon monoxide at 6 and 12 months ( intention to treat ) . RESULTS At 24 weeks , 21.7 % of participants in the st and ard treatment arm were abstinent , compared with 27.2 % of participants in the extended and maintenance treatment arms ( χ(2)(1 ) = 1.98 ; P = .17 ) . In a multivariate model controlled for covariates , participants in the extended and maintenance treatment arms reported significantly greater abstinence rates at 24 weeks compared with participants in the st and ard treatment arm ( odds ratio [ OR ] , 1.70 [ 95 % CI , 1.03 - 2.81 ] ; P = .04 ) , had a longer duration of abstinence until relapse ( β = 21.30 [ 95 % CI , 10.30 - 32.25 ] ; P < .001 ) , reported smoking fewer cigarettes per day if not abstinent ( mean [ SD ] , 5.8 [ 5.3 ] vs 6.4 [ 5.1 ] cigarettes per day ; β = 0.43 [ 95 % CI , 0.06 - 0.82 ] ; P = .02 ) , and reported more abstinent days ( mean [ SD ] , 80.5 [ 38.1 ] vs 68.2 [ 43.7 ] days ; OR , 1.55 [ 95 % CI , 1.06 - 2.26 ] ; P = .02 ) . At 52 weeks , participants in the maintenance treatment arm did not report significantly greater abstinence rates compared with participants in the st and ard and extended treatment arms ( 20.3 % vs 23.8 % ; OR , 1.17 [ 95 % CI , 0.69 - 1.98 ] ; P = .57 ) . Similarly , we found no difference in week 52 abstinence rates between participants in the extended and st and ard treatment arms ( 26.0 % vs 21.7 % ; OR , 1.33 [ 95 % CI , 0.72 - 2.45 ] ; P = .36 ) . Treatment duration was not associated with any adverse effects or adherence to the counseling regimen , but participants in the maintenance treatment arm reported lower adherence to the nicotine patch regimen compared with those in the st and ard and extended treatment arms ( mean [ SD ] , 3.94 [ 2.5 ] , 4.61 [ 2.0 ] , and 4.7 [ 2.4 ] patches/wk , respectively ; F2,522 = 6.03 ; P = .003 ) . CONCLUSIONS AND RELEVANCE The findings support the safety of long-term use of nicotine patch treatment , although they do not support efficacy beyond 24 weeks of treatment in a broad group of smokers . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01047527 Background The use of nicotine replacement therapy before quitting smoking is called nicotine preloading . St and ard smoking cessation protocol s suggest commencing nicotine replacement therapy only on the first day of quitting smoking ( quit day ) aim ing to reduce withdrawal symptoms and craving . However , other , more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after . Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward . A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed . Methods / Design This is a study protocol for a multicenter , non-blinded , r and omized controlled trial based in the United Kingdom , enrolling 1786 smokers who want to quit , funded by the National Institute for Health Research , Health Technology Assessment program , and sponsored by the University of Oxford . Participants will primarily be recruited through general practice s and smoking cessation clinics , and r and omized ( 1:1 ) either to use 21 mg nicotine patches , or not , for four weeks before quitting , whilst smoking as normal . All participants will be referred to receive st and ard smoking cessation service support . Follow-ups will take place at one week , four weeks , six months and 12 months after quit day . The primary outcome will be prolonged , biochemically verified six-month abstinence . Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration , side effects , costs of treatment , and markers of potential mediators and moderators of the preloading effect . Discussion This large trial will add substantially to evidence on the effectiveness of nicotine preloading , but also on its cost effectiveness and potential mediators , which have not been investigated in detail previously . A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample , and the multicentre design means that knowledge can be shared between recruitment teams . The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of st and ard smoking cessation service practice .Trial registration Current Controlled Trials IS RCT N33031001 . Registered 27 April 2012 BACKGROUND Smoking is considered as an addiction to nicotine for most subjects consuming 10 cigarettes or more per day . Hence , nicotine replacement therapy by way of gum , patch , or spray has been advocated . The rationale of this study is to evaluate the possible beneficial effects of adding nicotine gum to the routine of subjects using the nicotine patch . The effect of the nicotine patch against the placebo , both groups receiving placebo nicotine gum , has also been assessed . METHODS Healthy subjects ( 374 ) were r and omized at their work- setting in a 1-year double-blind placebo-controlled trial : 149 subjects to active nicotine patch + active gum ( group 1 ) , 150 to active nicotine patch + placebo gum ( group 2 ) , and 75 to placebo patch + gum ( group 3 ) . Treatment duration was 12 weeks with a 16-hr transdermal patch of 15 mg , followed by a 6 + 6-weeks weaning period on respectively 10 and 5 mg patches . Gum use was not restricted during the first 6 months , with recommendations to use at least four pieces a day . A strict definition of smoking abstinence was used in this study , which did not allow smoking any cigarette after Week 1 . Nonsmoking status at each visit , as reported by the subjects , was verified by CO below 10 ppm in expired air . RESULTS Abstinence rates in group 1 against group 2 were 34.2 and 22.7 % ( P = 0.027 ) at 12 weeks , 27.5 and 15.3 % ( P = 0.010 ) at 24 weeks , and 18.1 and 12.7 % ( P = 0.191 ) at 52 weeks . In group 3 , abstinence rates were 17.3 , 14.7 , and 13.3 % respectively at 12 , 24 , and 52 weeks . Using logistic regression with adjustment for six baseline covariates , odds ratios for abstinence ( with 95 % CI ) were computed . For group 1/group 2 , OR at 12 , 24 , and 52 weeks were 1.72 ( 1.03 - 2.94 ) ( P = 0.039 ) , 2.04 ( 1.14 - 3.57 ) ( P = 0.018 ) , and 1.47 ( 0.76 - 2.76 ) ( P = 0.125 ) . No significant differences in OR were observed when comparing groups 2 and 3 . Time to relapse is significantly longer in group 1 as compared to that of group 2 ( P = 0.041 ) , whereas no significant differences between groups 2 and 3 were observed . No significant differences between the three groups in systemic and local adverse drug events were observed . CONCLUSION Adding active gum use to active patch use in subjects smoking 10 cigarettes or more a day increased abstinence rates , which are statistically significant up to 24 weeks Objective To assess the impact of instructional guidance in
Output:
| Five studies comparing 4 mg gum to 2 mg gum found a benefit of the higher dose ( RR 1.43 , 95 % CI 1.12 to 1.83 , 5 studies , 856 participants ; I2 = 63 % ) ; however , results of a subgroup analysis suggest that only smokers who are highly dependent may benefit .
Most comparisons found no evidence of an effect on cardiac AEs , SAEs or withdrawals .
There is high-certainty evidence that using combination NRT versus single-form NRT , and 4 mg versus 2 mg nicotine gum , can increase the chances of successfully stopping smoking .
There was no clear evidence of superiority for 42/44 mg over 21/22 mg ( 24-hour ) patches .
Using a fast-acting form of NRT , such as gum or lozenge , result ed in similar quit rates to nicotine patches . |
MS213122 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective To evaluate the effect of 8-week moderate intensity aerobic ( heart-rate reserve 40–60 % ) exercise on neuropathy quality of life in type 2 diabetes . Methods A single blind , parallel-group , r and omized controlled trial was carried out in a tertiary setting . People with type 2 diabetes were eligible for the study if they had clinical neuropathy which was defined by a minimum score of seven on the Michigan diabetic neuropathy score . Following which , the patients were r and omly assigned to an 8-week program by a computer-generated r and om number tables to intervention or control group . Repeated measure analysis of variance was used for data analysis ( p < 0.05 was considered significant ) . Results There were 47 participants in the control group and 40 participants in the study group after r and omization but 37 from the control group and 29 from the intervention group completed the final analysis . The two groups had a significant difference , pre – post intervention in scores of pain ( F = 7 , p = 0.01 ) , sensory symptoms ( F = 4.60 , p = 0.04 ) , restricted activities of daily living ( F = 4.97 , p = 0.03 ) , disruptions in social relationships ( F = 5.43 , p = 0.02 ) , specific impact on quality of life ( F = 9.28 , p < 0.001 ) overall quality of life ( F = 28.72 , p < 0.001 ) , and total score ( F = 31.10 , p < 0.001 ) . Degrees of freedom for all the components were 1 , 62 . Conclusion Moderate intensity aerobic exercise is cornerstone in improving the quality of life of individuals with peripheral neuropathy in type 2 diabetes Abstract Complex regional pain syndrome type I ( CRPS-I ) highly affects patients ' ability to perform daily life activities . Pain-related fear might be a key target to reduce disability in chronic pain . Current treatments aim ing at reducing pain show little improvements on pain and disability , whereas novel exposure-based treatments targeting pain-related fears have shown to be promising . We conducted a r and omized controlled trial ( N = 46 ) comparing exposure in vivo ( EXP ) with pain-contingent treatment as usual ( TAU ) , for CRPS-I patients with at least moderate levels of pain-related fear . Primary outcome is self-reported disability , for upper and lower extremity , respectively . Secondary outcomes are self-reported pain-intensity , pain-catastrophizing , perceived harmfulness of physical activity , and health-related quality of life . Pretreatment to posttreatment and pretreatment to 6-month follow-up change scores were tested using r and omization-based inference . EXP was superior to TAU in reducing upper extremity disability from pretreatment to posttreatment ( between-group difference , 1.082 ; 95 % confidence interval [ CI ] , 0.563 - 1.601 ; P < 0.001 ) and from pretreatment to 6-month follow-up ( 1.303 ; 95 % CI , 0.917 - 1.690 ; P < 0.001 ) . EXP was superior in reducing lower extremity disability from pretreatment to 6-month follow-up ( 3.624 ; 95 % CI , 0.467 - 6.781 ; P = 0.02 ) , but not from pretreatment to posttreatment ( 3.055 ; 95 % CI , −0.018 to 6.128 ; P = 0.054 ) . All secondary outcomes significantly favored EXP pretreatment to posttreatment , as well as pretreatment to 6-month follow-up . Exposure to daily activities shows to be more effective than a protective pain-contingent TAU in reducing self-reported disability in daily life of CRPS-I patients with at least moderate levels of pain-related fear PURPOSE The aim of this study was to determine the effects of Tai Chi exercise on glucose control , neuropathy scores , balance , and quality of life in patients with type 2 diabetes and neuropathy . METHODS A pretest-posttest design with a nonequivalent control group was utilized to recruit 59 diabetic patients with neuropathy from an outpatient clinic of a university hospital . A st and ardized Tai Chi for diabetes program was provided , which comprised 1 hour of Tai Chi per session , twice a week for 12 weeks . Outcome variables were fasting blood glucose and glycosylated hemoglobin for glucose control , the Semmes-Weinstein 10-g monofilament examination scores and total symptom scores for neuropathy , single leg stance for balance , and the Korean version of the SF-36v2 for quality of life . Thirty-nine patients completed the posttest measures after the 12-week Tai Chi intervention , giving a 34 % dropout rate . RESULTS The mean age of the participants was 64 years , and they had been diagnosed with type 2 diabetes for more than 12 years . The status was significantly better for the participants in the Tai Chi group ( n=20 ) than for their control ( i.e. , nonintervention ) counterparts ( n=19 ) in terms of total symptom scores , glucose control , balance , and quality of life . CONCLUSION Tai Chi improved glucose control , balance , neuropathic symptoms , and some dimensions of quality of life in diabetic patients with neuropathy . Further studies with larger sample s and long-term follow-up are needed to confirm the effects of Tai Chi on the management of diabetic neuropathy , which may have an impact on fall prevention in this population Aims /hypothesisStructured exercise is considered a cornerstone in type 2 diabetes treatment . However , adherence to combined resistance and endurance type exercise or medical fitness intervention programmes is generally poor . Group-based brisk walking may represent an attractive alternative , but its long-term efficacy as compared with an individualised approach such as medical fitness intervention programmes is unknown . We compared the clinical benefits of a 12-month exercise intervention programme consisting of either brisk walking or a medical fitness programme in type 2 diabetes patients . Methods We r and omised 92 type 2 diabetes patients ( 60 ± 9 years old ) to either three times a week of 60 min brisk walking ( n = 49 ) or medical fitness programme ( n = 43 ) . Primary outcome was the difference in changes in HbA1c values at 12 months . Secondary outcomes were differences in changes in blood pressure , plasma lipid concentrations , insulin sensitivity , body composition , physical fitness , programme adherence rate and health-related quality of life . Results After 12 months , 18 brisk walking and 19 medical fitness participants were still actively participating . In both programmes , 50 and 25 % of the dropout was attributed to overuse injuries and lack of motivation , respectively . Intention-to-treat analyses showed no important differences between brisk walking and medical fitness programme in primary or secondary outcome variables . Conclusions /interpretationThe prescription of group-based brisk walking represents an equally effective intervention to modulate glycaemic control and cardiovascular risk profile in type 2 diabetes patients when compared with more individualised medical fitness programmes . Future exercise intervention programmes should anticipate the high attrition rate due to overuse injuries and motivation problems & NA ; Fear of (re)injury/movement has been identified as a potential predictor of chronic disability in complex regional pain syndrome type I ( CRPS‐I ) . In order to reduce pain‐related fears and pain disability , grade d exposure in vivo ( GEXP ) is likely to be an appropriate treatment . Indeed , there is evidence that in chronic pain patients reporting substantial fear of (re)injury/movement , GEXP is successful in reducing pain disability . However , the efficacy of exposure‐based protocol s in the treatment of CRPS‐I patients for reducing pain disability has not been tested . The main research question of this study was whether the reduction of pain‐related fear through GEXP also result ed in a decrease of disability in a subgroup of patients with CRPS‐I who report substantial pain‐related fear . A single‐case experimental ABCD‐ design was used with r and om determination of the start of the intervention . Eight patients with CRPS‐I were included in the study . To assess daily changes in pain intensity , pain‐related fear , pain catastrophizing , and activity goal achievement , a diary was used . St and ardized question naires of pain‐related fear , pain disability , and self‐reported signs and symptoms of CRPS‐I were administered before and after each intervention , and at 6‐month follow‐up . The current study supports a GEXP approach to chronic CRPS‐I. The GEXP was successful in decreasing levels of self‐reported pain‐related fear , pain intensity , disability , and physiological signs and symptoms . These results support the hypothesis that the meaning people attach to a noxious stimulus influences its experienced painfulness , and that GEXP activates cortical networks and reconciles motor output and sensory feedback & NA ; Since pain‐related fear may contribute to the development and maintenance of chronic low back pain ( CLBP ) , an exposure in vivo treatment ( EXP ) was developed for CLBP patients . We examined the effectiveness as well as specific mediating mechanisms of EXP versus operant grade d activity ( GA ) directly and 6 months post‐treatment in a multi‐centre r and omized controlled trial . In total , 85 patients suffering from disabling non‐specific CLBP reporting at least moderate pain‐related fear were r and omly allocated to EXP or GA . It was demonstrated that EXP , despite excelling in diminishing pain catastrophizing and perceived harmfulness of activities , was equally effective as GA in improving functional disability and main complaints , although the group difference almost reached statistical significance favouring EXP . Both treatment conditions did not differ in pain intensity and daily activity levels either . Nor was EXP superior to GA in the subgroup of highly fearful patients . Irrespective of treatment , approximately half the patients reported clinical ly relevant improvements in main complaints and functional disability , although for the latter outcome the group difference was almost significant favouring EXP . Furthermore , the effect of EXP relative to GA on functional disability and main complaints was mediated by decreases in catastrophizing and perceived harmfulness of activities . In sum , this study demonstrates that up to 6 months after treatment EXP is an effective treatment , but not more effective than GA , in moderately to highly fearful CLBP patients , although its superiority in altering pain catastrophizing and perceived harmfulness of activities is clearly established . Possible explanations for these findings are discussed OBJECTIVE To evaluate the effect of moderate intensity aerobic exercise ( 40%-60 % of Heart Rate Reserve ( HRR ) ) on diabetic peripheral neuropathy . METHODS A parallel-group , r and omized controlled trial was carried out in a tertiary health care setting , India . The study comprised of experimental ( moderate intensity aerobic exercise and st and ard care ) and control groups ( st and ard care ) . Population with type 2 diabetes with clinical neuropathy , defined as a minimum score of seven on the Michigan Diabetic Neuropathy Score ( MDNS ) , was r and omly assigned to experimental and control groups by computer generated r and om number tables . RANOVA was used for data analysis ( p<0.05 was significant ) . RESULTS A total of 87 patients with DPN were evaluated in the study . After r and omization there were 47 patients in the control group and 40 patients in the experimental group . A comparison of two groups using RANOVA for anthropometric measures showed an insignificant change at eight weeks . For distal peroneal nerve 's conduction velocity there was a significant difference in two groups at eight weeks ( p<0.05 ) , Degrees of freedom (Df)=1 , 62 , F=5.14 , and p=0.03 . Sural sensory nerve at eight weeks showed a significant difference in two groups for conduction velocity , Df = 1 , 60 , F=10.16 , and p=0.00 . Significant differences in mean scores of MDNS were also observed in the two groups at eight weeks ( p value significant<0.05 ) . CONCLUSION Moderate intensity aerobic exercises can play a valuable role to disrupt the normal progression of DPN in type 2 diabetes Background and objectiveS everal cognitive – behavioral factors contribute to the persistence of pain disability in patients with chronic back pain . Fear-avoidance beliefs and fear of movement/(re)injury in particular have been shown to be strong predictors of physical performance and pain disability . Patients reporting substantial pain-related fear might benefit from exposure in vivo to a set of individually tailored , fear-eliciting , and hierarchically ordered physical movements rather than more general grade d activity . Patients and interventions Six consecutive patients with chronic low back pain who reported substantial fear of movement/(re)injury were included in the study . After a no-treatment baseline measurement period , the patients were r and omly assigned to one of two interventions . In the first intervention , patients received exposure in vivo first , followed by grade d activity . In the second intervention , the sequence of treatment modules was reversed . Before each treatment module , treatment credibility was assessed . Daily measures of pain-related fear , pain catastrophizing , and pain intensity were completed using visual analog scales . In addition , st and ardized measures of pain disability , pain-related fear , and pain vigilance were taken before and after each treatment module and at the 1-year follow-up . To obtain more objective data on actual activity levels , an ambulatory activity monitor was carried by the patients during 1 week before and after each treatment module . Results Time series analysis of the daily measures showed that improvements in pain-related fear and pain catastrophizing occurred only during the exposure in vivo and not during the grade d activity , irrespective of the treatment order . Analysis of the pretreatment to post-treatment differences also revealed that decreases in pain-related fear also concurred with decreases in pain disability and pain vigil
Output:
| Conclusions Based on increasing knowledge in the domain of chronic pain , it could be assumed that integrated rehabilitation treatments for patients with PDN are beneficial .
There is no literature to support this and more research should be done on integrated biopsychosocial interventions in patients with PDN . |
MS213123 | ***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 Low socio-economic status ( SES ) is an established risk factor of suicidal behaviours , but it is unknown to what extent its association is direct , indirect or confounded , given its strong association to mental health . We aim ed to ( I ) estimate the prevalence of suicidal behaviours ; ( II ) describe relevant risk factors ; and ( III ) investigate direct and indirect effects of SES on suicidal behaviours . METHODS We used cross-sectional community survey data of adults from r and omly selected South East London households ( SELCoH ) . Suicidal outcome measures replicated the 2007 Adult Psychiatric Morbidity Survey in Engl and ( APMS ) . Lifetime prevalence was described by socio-demographics , SES , mental health indicators , and life events . Structured symptom screens and a drug use question naire measured mental health . Structural equation models estimated direct and indirect effects of a latent SES variable on suicidal ideation and suicide attempts , adjusting for covariates . RESULTS 20.5 % ( 95 % CI : 18.4 - 22.7 ) reported suicidal ideation and 8.1 % ( 95 % CI : 6.8 - 9.7 ) reported suicide attempts ( higher than APMS estimates : 13.7 % , 4.8 % , respectively ) . Unadjusted risk factors included poor mental health , low SES , and non-married/non-cohabitating relationship status . Black African ethnicity was protective , and women reported more suicide attempts . SES was directly associated to suicide attempts , but not suicidal ideation . SES had indirect effects on suicidal outcomes via mental health and life events . LIMITATIONS The cross-sectional design and application of measures for different time periods did not allow for causal inferences . CONCLUSIONS Suicidal behaviours were more prevalent than in the general UK population . Interventions targeting low SES individuals may prove effective in preventing suicide attempts Purpose Previous cross-sectional studies have indicated that homeless individuals may present with high rates of suicidal ideation , which are strongly associated with completed suicide . We conducted the first known longitudinal study of suicidal ideation in the homeless . Methods We used data collected over 24 months in the Vancouver At Home project ( N = 497 ) , comprised two r and omized-controlled trials of housing interventions for homeless individuals with mental disorders . Presence of suicidal ideation was determined using the Colorado symptom index . Results Suicidal ideation significantly decreased over time [ odds ratio ( OR ) = 0.31 at 24 months , 95 % confidence interval ( CI ) 0.21–0.46 ] . Baseline diagnoses of mood ( OR = 2.18 , 95 % CI 1.48–3.21 ) and anxiety disorders ( OR = 2.05 , 95 % CI 1.42–2.97 ) , as well as depressive mood ( OR = 2.52 , 95 % CI 1.90–3.33 ) , use of any substance ( OR = 1.59 , 95 % CI 1.09–2.32 ) , and polysubstance use ( OR = 1.90 , 95 % CI 1.40–2.60 ) were significantly associated with suicidal ideation in the multivariate model . Baseline diagnosis of a psychotic disorder ( protective effect ) , daily substance use , intravenous drug use , recent arrest , multiple physical illnesses and history of traumatic brain injury were significantly associated with suicidal ideation in the unadjusted model only . Conclusions Interventions targeting depressive symptoms and substance use could help decrease suicide risk in homeless individuals . Mental health services need to be tailored to address the complex needs of socially marginalized individuals . Trial registration Current controlled trials : IS RCT N57595077 ( Vancouver At Home study : Housing First plus Assertive Community Treatment versus congregate housing plus supports versus treatment as usual ) and IS RCT N66721740 ( Vancouver At Home study : Housing first plus intensive case management versus treatment as usual ) . Assigned 9 Oct. 2012 Background People with severe mental disorders are associated with increased risk of suicide and suicide attempts compared to the general population . In low and middle-income countries , research concerning suicide attempts and completed suicide among people living with severe mental disorder is limited . The objective of this study was to assess suicide and attempts in people with severe mental disorder at Amanuel Mental Specialized Hospital , Addis Ababa , Ethiopia . Methods Institution-based cross-sectional study was conducted in August – September 2016 . Patients with schizophrenia and bipolar disorder were selected using systematic r and om-sampling technique . The composite international diagnostic interview was used to assess suicide that was administered by psychiatry professionals . Substance use disorder was assessed through face-to-face interviews using structured clinical interview of DSM-IV . Results A total of 542 ( 272 schizophrenia + 270 bipolar disorder ) patients were included in the study . One hundred nineteen ( 43.75 % ) of schizophrenic participants and 128 ( 47.1 % ) of bipolar participants have suicidal ideation . Fifty-six ( 20.7 % ) of schizophrenic participants and 58 ( 21.3 % ) of bipolar participants have suicidal attempt . Among the schizophrenic and bipolar patients who had suicidal ideation , 31.8 and 32.60 % had co-morbid substance use disorder , respectively . Conclusion In this study , which was performed in Ethiopia , suicidal ideation and attempt were shown to be common problems in people with schizophrenia and bipolar disorder . Co-morbid substance use disorder was a more frequent phenomenon among patients with suicidal ideation and attempt . Attention should be given to screen and assess suicidal ideation and attempt in persons with schizophrenia and bipolar disorder ABSTRACT Background : Traumatic life events have been associated with increased risk of various psychiatric disorders , even suicidality . Our aim was to investigate the association between different traumatic life events and suicidality , by type of event and gender . Methods : Women attending a cancer screening programme in Icel and ( n = 689 ) and a r and om sample of men from the general population ( n = 709 ) were invited to participate . In a web-based question naire , life events were assessed with the Life Stressor Checklist – Revised , and the Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition ( DSM-5 ) criterion was used to identify traumatic life events . Reports of lifetime suicidal thoughts , self-harm with suicidal intent and suicide attempt were considered as lifetime suicidality . We used Poisson regression , adjusted for demographic factors , to express relative risks ( RRs ) as a measure of the associations between traumatic events and suicidality . Results : Response rate was 66 % ( 922/1398 ) . The prevalence of lifetime traumatic events was 76 % among women and 77 % among men . Lifetime suicidality was 11 % among women and 16 % among men . An overall association of having experienced traumatic life events with suicidality was observed [ RR 2.05 , 95 % confidence interval ( CI ) 1.21–3.75 ] , with a stronger association for men ( RR 3.14 , 95 % CI 1.25–7.89 ) than for women ( RR 1.45 , 95 % CI 0.70–2.99 ) . Increased likelihood for suicidality was observed among those who had experienced interpersonal trauma ( RR 2.97 , 95 % CI 1.67–5.67 ) , childhood trauma ( RR 4.09 , 95 % CI 2.27–7.36 ) and sexual trauma ( RR 3.44 , 95 % CI 1.85–6.37 ) , with a higher likelihood for men . In addition , an association between non-interpersonal trauma and suicidality was noted among men ( RR 3.27 , 95 % CI 1.30–8.25 ) but not women ( RR 1.27 , 95 % CI 0.59–2.70 ) . Conclusion : Findings indicate that traumatic life events are associated with suicidality , especially among men , with the strongest association for interpersonal trauma
Output:
| The current review revealed a remarkably higher magnitude of suicidal ideation and attempt among homeless people as compared to the estimated prevalence in the general population . |
MS213124 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives To investigate the association between long term intake of individual saturated fatty acids ( SFAs ) and the risk of coronary heart disease , in two large cohort studies . Design Prospect i ve , longitudinal cohort study . Setting Health professionals in the United States . Participants 73 147 women in the Nurses ’ Health Study ( 1984 - 2012 ) and 42 635 men in the Health Professionals Follow-up Study ( 1986 - 2010 ) , who were free of major chronic diseases at baseline . Main outcome measure Incidence of coronary heart disease ( n=7035 ) was self-reported , and related deaths were identified by search ing National Death Index or through report of next of kin or postal authority . Cases were confirmed by medical records review . Results Mean intake of SFAs accounted for 9.0 - 11.3 % energy intake over time , and was mainly composed of lauric acid ( 12:0 ) , myristic acid ( 14:0 ) , palmitic acid ( 16:0 ) , and stearic acid ( 18:0 ; 8.8 - 10.7 % energy ) . Intake of 12:0 , 14:0 , 16:0 and 18:0 were highly correlated , with Spearman correlation coefficients between 0.38 and 0.93 ( all P<0.001 ) . Comparing the highest to the lowest groups of individual SFA intakes , hazard ratios of coronary heart disease were 1.07 ( 95 % confidence interval 0.99 to 1.15 ; Ptrend=0.05 ) for 12:0 , 1.13 ( 1.05 to 1.22 ; Ptrend<0.001 ) for 14:0 , 1.18 ( 1.09 to 1.27 ; Ptrend<0.001 ) for 16:0 , 1.18 ( 1.09 to 1.28 ; Ptrend<0.001 ) for 18:0 , and 1.18 ( 1.09 to 1.28 ; Ptrend<0.001 ) for all four SFAs combined ( 12:0 - 18:0 ) , after multivariate adjustment of lifestyle factors and total energy intake . Hazard ratios of coronary heart disease for isocaloric replacement of 1 % energy from 12:0 - 18:0 were 0.92 ( 95 % confidence interval 0.89 to 0.96 ; P<0.001 ) for polyunsaturated fat , 0.95 ( 0.90 to 1.01 ; P=0.08 ) for monounsaturated fat , 0.94 ( 0.91 to 0.97 ; P<0.001 ) for whole grain carbohydrates , and 0.93 ( 0.89 to 0.97 ; P=0.001 ) for plant proteins . For individual SFAs , the lowest risk of coronary heart disease was observed when the most abundant SFA , 16:0 , was replaced . Hazard ratios of coronary heart disease for replacing 1 % energy from 16:0 were 0.88 ( 95 % confidence interval 0.81 to 0.96 ; P=0.002 ) for polyunsaturated fat , 0.92 ( 0.83 to 1.02 ; P=0.10 ) for monounsaturated fat , 0.90 ( 0.83 to 0.97 ; P=0.01 ) for whole grain carbohydrates , and 0.89 ( 0.82 to 0.97 ; P=0.01 ) for plant proteins . Conclusions Higher dietary intakes of major SFAs are associated with an increased risk of coronary heart disease . Owing to similar associations and high correlations among individual SFAs , dietary recommendations for the prevention of coronary heart disease should continue to focus on replacing total saturated fat with more healthy sources of energy BACKGROUND The high consumption of low-fat and nonfat dairy products is associated with reduced risk of high blood pressure . OBJECTIVE We aim ed to investigate whether the solitary addition of nonfat dairy products to the normal routine diet was capable of lowering blood pressure in middle-aged and older adults with elevated blood pressure . DESIGN With the use of a r and omized , crossover intervention- study design , 49 adults ( 56 % women ) with elevated blood pressure ( mean ± SEM age : 53 ± 2 y ; systolic blood pressure : 135 ± 1 ; diastolic blood pressure : 80 ± 1 mm Hg ) underwent a high-dairy condition ( + 4 servings conventional nonfat dairy products/d ) and isocaloric no-dairy condition ( + 4 servings fruit products/d ) in which all dairy products were removed . Both dietary conditions lasted 4 wk with a 2-wk washout before crossing over into the alternate condition . RESULTS The high-dairy condition produced reductions in systolic blood pressure ( 135 ± 1 to 127 ± 1 mm Hg ) and pulse pressure ( 54 ± 1 to 48 ± 1 mm Hg ) ( both P < 0.05 ) . The hypotensive effects were observed within 3 wk after the initiation of the dietary intervention and in both casual seated and ambulatory ( 24-h ) measurements ( P < 0.05 ) . Pulse pressure was increased after the removal of all dairy products in the no-dairy condition ( 54 ± 1 to 56 ± 1 mm Hg ; P < 0.05 ) . There were no changes in diastolic blood pressure after either dietary condition . CONCLUSION We concluded that the solitary manipulation of conventional dairy products in the normal routine diet would modulate blood pressure in middle-aged and older adults with prehypertension and hypertension . This trial was registered at clinical trials.gov as NCT01577030 BACKGROUND AND AIMS The prevalence of type 2 diabetes ( T2DM ) is increasing . Several studies have suggested a beneficial effect of several major dairy nutrients on insulin production and sensitivity . Conversely , harmful effects have been suggested as well . This study aim ed to investigate the impact of the full-range of dairy products and its association with incidence T2DM in Dutch adults aged ≥55 years participating in the Rotterdam Study . METHODS AND RESULTS Dairy intake was assessed with a vali date d FFQ , including total , skimmed , semi-skimmed , full-fat , fermented , and non-fermented dairy , and subclasses of these product groups . Verified prevalent and incident diabetes were documented . Cox proportional hazards regression and spline regression were used to analyse data , adjusting for age , sex , alcohol , smoking , education , physical activity , body mass index , intake of total energy , energy-adjusted meat , and energy-adjusted fish intake . Median total dairy intake was 398 g/day ( IQR 259 - 559 g/day ) . Through 9.5 ± 4.1 years of follow-up , 393 cases of incident T2DM were reported . Cox and spline regression did not point towards associations of total dairy consumption , dairy consumption based on fat content , non-fermented or fermented dairy consumption , or individual dairy product consumption with incident T2DM . The HR for total dairy intake and T2DM was 0.93 ( 95 % CI : 0.70 - 1.23 ) in the upper quartile ( P-for trend 0.76 ) . CONCLUSIONS This prospect i ve cohort study did not point towards an association between dairy consumption and T2DM The association between consumption of full-fat dairy foods and CVD may depend partly on the nature of products and may not apply to low-fat dairy foods . Increased circulating levels of inflammatory biomarkers after consumption of dairy product-rich meals suggest an association with CVD . In the present study , we tested the effects of low-fat and full-fat dairy diets on biomarkers associated with inflammation , oxidative stress or atherogenesis and on plasma lipid classes . Within full-fat dairy diets , we also compared fermented v. non-fermented products . In a r and omised cross-over study , twelve overweight/obese subjects consumed during two 3-week periods two full-fat dairy diets containing either yogurt plus cheese ( fermented ) or butter , cream and ice cream ( non-fermented ) or a low-fat milk plus yogurt diet , with the latter being consumed between and at the end of the full-fat dairy dietary periods . The concentrations of six inflammatory and two atherogenic biomarkers known to be raised in CVD were measured as well as those of plasma F2-isoprostanes and lipid classes . The concentrations of six of the eight biomarkers tended to be higher on consumption of the low-fat dairy diet than on that of the fermented dairy diet and the concentrations of two plasmalogen lipid classes reported to be associated with increased oxidisability were also higher on consumption of the low-fat dairy diet than on that of the fermented dairy diet ( P < 0.001 ) , although plasma F2-isoprostane concentrations did not differ on consumption of any of the diets . On the other h and , the concentrations of plasma sphingomyelin and IL-6 were significantly higher on consumption of the non-fermented dairy diet than on that of the low-fat dairy diet ( P < 0.02 ) . In conclusion , short-term diets containing low-fat dairy products did not lead to a more favourable biomarker profile associated with CVD risk compared with the full-fat dairy products , suggesting that full-fat fermented dairy products may be the more favourable BACKGROUND & AIMS Nonalcoholic fatty liver disease ( NAFLD ) is associated with increased risk of hepatic , cardiovascular , and metabolic diseases . High-protein diets , rich in methionine and branched chain amino acids ( BCAAs ) , apparently reduce liver fat , but can induce insulin resistance . We investigated the effects of diets high in animal protein ( AP ) vs plant protein ( PP ) , which differ in levels of methionine and BCAAs , in patients with type 2 diabetes and NAFLD . We examined levels of liver fat , lipogenic indices , markers of inflammation , serum levels of fibroblast growth factor 21 ( FGF21 ) , and activation of signaling pathways in adipose tissue . METHODS We performed a prospect i ve study of individuals with type 2 diabetes and NAFLD at a tertiary medical center in Germany from June 2013 through March 2015 . We analyzed data from 37 subjects placed on a diet high in AP ( rich in meat and dairy foods ; n = 18 ) or PP ( mainly legume protein ; n = 19 ) without calorie restriction for 6 weeks . The diets were isocaloric with the same macronutrient composition ( 30 % protein , 40 % carbohydrates , and 30 % fat ) . Participants were examined at the start of the study and after the 6-week diet period for body mass index , body composition , hip circumference , resting energy expenditure , and respiratory quotient . Body fat and intrahepatic fat were detected by magnetic resonance imaging and spectroscopy , respectively . Levels of glucose , insulin , liver enzymes , and inflammation markers , as well as individual free fatty acids and free amino acids , were measured in collected blood sample s. Hyperinsulinemic euglycemic clamps were performed to determine whole-body insulin sensitivity . Subcutaneous adipose tissue sample s were collected and analyzed for gene expression patterns and phosphorylation of signaling proteins . RESULTS Postpr and ial levels of BCAAs and methionine were significantly higher in subjects on the AP vs the PP diet . The AP and PP diets each reduced liver fat by 36%-48 % within 6 weeks ( for AP diet P = .0002 ; for PP diet P = .001 ) . These reductions were unrelated to change in body weight , but correlated with down-regulation of lipolysis and lipogenic indices . Serum level of FGF21 decreased by 50 % in each group ( for AP diet P < .0002 ; for PP diet P < .0002 ) ; decrease in FGF21 correlated with loss of hepatic fat . In gene expression analyses of adipose tissue , expression of the FGF21 receptor cofactor β-klotho was associated with reduced expression of genes encoding lipolytic and lipogenic proteins . In patients on each diet , levels of hepatic enzymes and markers of inflammation decreased , insulin sensitivity increased , and serum level of keratin 18 decreased . CONCLUSIONS In a prospect i ve study of patients with type 2 diabetes , we found diets high in protein ( either animal or plant ) significantly reduced liver fat independently of body weight , and reduced markers of insulin resistance and hepatic necroinflammation . The diets appear to mediate these changes via lipolytic and lipogenic pathways in adipose tissue . Negative effects of BCAA or methionine were not detectable . FGF21 level appears to be a marker of metabolic improvement . Clinical Trials.gov ID NCT02402985 BACKGROUND Dairy product intake may be inversely associated with risk of type 2 diabetes ,
Output:
| In fact , the weight of evidence from recent large and well-controlled studies , systematic review s , and meta-analyses of both observational studies and r and omized controlled trials indicates that full-fat dairy products , particularly yogurt and cheese , do not exert the detrimental effects on insulin sensitivity , blood lipid profile , and blood pressure as previously predicted on the basis of their sodium and saturated fat contents ; they do not increase cardiometabolic disease risk and may in fact protect against cardiovascular disease and type 2 diabetes . |
MS213125 | ***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 Three clinical trials on the use of tamoxifen to prevent breast cancer have reported mixed results . The overall evidence supports a reduction in the risk of breast cancer , but whether this benefit outweighs the risks and side-effects associated with tamoxifen is unclear . METHODS We undertook a double-blind placebo-controlled r and omised trial of tamoxifen , 20 mg/day for 5 years , in 7152 women aged 35 - 70 years , who were at increased risk of breast cancer . The primary outcome measure was the frequency of breast cancer ( including ductal carcinoma in situ ) . Analyses were by intention to treat after exclusion of 13 women found to have breast cancer at baseline mammography . FINDINGS After median follow-up of 50 months ( IQR 32 - 67 ) , 69 breast cancers had been diagnosed in 3578 women in the tamoxifen group and 101 in 3566 in the placebo group ( risk reduction 32 % [ 95 % CI 8 - 50 ] ; p=0.013 ) . Age , degree of risk , and use of hormone-replacement therapy did not affect the reduction . Endometrial cancer was non-significantly increased ( 11 vs 5 ; p=0.2 ) and thromboembolic events were significantly increased with tamoxifen ( 43 vs 17 ; odds ratio 2.5 [ 1.5 - 4.4 ] , p=0.001 ) , particularly after surgery . There was a significant excess of deaths from all causes in the tamoxifen group ( 25 vs 11 , p=0.028 ) . INTERPRETATION Prophylactic tamoxifen reduces the risk of breast cancer by about a third . Temporary cessation of tamoxifen should be considered and the use of appropriate antithrombotic measures is recommended during and after major surgery or periods of immobilisation . Prophylactic use of tamoxifen is contraindicated in women at high risk of thromboembolic disease . The combined evidence indicates that mortality from non-breast-cancer causes is not increased by tamoxifen . The overall risk to benefit ratio for the use of tamoxifen in prevention is still unclear , and continued follow-up of the current trials is essential BACKGROUND Ipsilateral breast tumor recurrence ( IBTR ) is the most common failure event after lumpectomy for ductal carcinoma in situ ( DCIS ) . We evaluated invasive IBTR ( I-IBTR ) and its influence on survival among participants in two National Surgical Adjuvant Breast and Bowel Project ( NSABP ) r and omized trials for DCIS . METHODS In the NSABP B-17 trial ( accrual period : October 1 , 1985 , to December 31 , 1990 ) , patients with localized DCIS were r and omly assigned to the lumpectomy only ( LO , n = 403 ) group or to the lumpectomy followed by radiotherapy ( LRT , n = 410 ) group . In the NSABP B-24 double-blinded , placebo-controlled trial ( accrual period : May 9 , 1991 , to April 13 , 1994 ) , all accrued patients were r and omly assigned to LRT+ placebo , ( n=900 ) or LRT + tamoxifen ( LRT + TAM , n = 899 ) . Endpoints included I-IBTR , DCIS-IBTR , contralateral breast cancers ( CBC ) , overall and breast cancer-specific survival , and survival after I-IBTR . Median follow-up was 207 months for the B-17 trial ( N = 813 patients ) and 163 months for the B-24 trial ( N = 1799 patients ) . RESULTS Of 490 IBTR events , 263 ( 53.7 % ) were invasive . Radiation reduced I-IBTR by 52 % in the LRT group compared with LO ( B-17 , hazard ratio [ HR ] of risk of I-IBTR = 0.48 , 95 % confidence interval [ CI ] = 0.33 to 0.69 , P < .001 ) . LRT + TAM reduced I-IBTR by 32 % compared with LRT + placebo ( B-24 , HR of risk of I-IBTR = 0.68 , 95 % CI = 0.49 to 0.95 , P = .025 ) . The 15-year cumulative incidence of I-IBTR was 19.4 % for LO , 8.9 % for LRT ( B-17 ) , 10.0 % for LRT + placebo ( B-24 ) , and 8.5 % for LRT + TAM . The 15-year cumulative incidence of all contralateral breast cancers was 10.3 % for LO , 10.2 % for LRT ( B-17 ) , 10.8 % for LRT + placebo ( B-24 ) , and 7.3 % for LRT + TAM . I-IBTR was associated with increased mortality risk ( HR of death = 1.75 , 95 % CI = 1.45 to 2.96 , P < .001 ) , whereas recurrence of DCIS was not . Twenty-two of 39 deaths after I-IBTR were attributed to breast cancer . Among all patients ( with or without I-IBTR ) , the 15-year cumulative incidence of breast cancer death was 3.1 % for LO , 4.7 % for LRT ( B-17 ) , 2.7 % for LRT + placebo ( B-24 ) , and 2.3 % for LRT + TAM . CONCLUSIONS Although I-IBTR increased the risk for breast cancer-related death , radiation therapy and tamoxifen reduced I-IBTR , and long-term prognosis remained excellent after breast-conserving surgery for DCIS BACKGROUND Inadequate surgical excision with residual involvement of resection margins by tumour after breast conservation results in increased local recurrence rates . To reduce this risk positive margins are , therefore , usually excised . Systemic treatment with tamoxifen or chemotherapy reduces local recurrence , along with radiotherapy . However , no studies to date have examined the correlation between chemoendocrine treatment , together with radiotherapy , and local relapse in patients with unexcised involved resection margins , having had breast conservation treatment . PATIENTS AND METHODS The histopathology reports were review ed of 184 patients who were treated from June 1991 to August 1995 within our r and omised study of neoadjuvant versus adjuvant chemoendocrine therapy with mitozantrone and methotrexate ( 2 M ) + /- mitomycin-C ( 3 M ) and tamoxifen , used concurrently with radiation following conservation surgical treatment . Histological resection margin was considered positive if ductal carcinoma in situ ( DCIS ) or invasive carcinoma was present microscopically less than 1 mm from the excision margin . RESULTS Although 38 % of patients had unexcised microscopically involved margins , local relapse rate as first site of relapse was only 1.9 % after a median follow up of 57 months . There was no difference in distant relapse ( P = 0.2 ) and survival ( P = 0.5 ) between the positive and negative margins groups . CONCLUSIONS The presence of positive unexcised margins does not have a significant effect on outcome in patients who are treated with chemoendocrine therapy together with radiotherapy . Further clinical trials are required We have investigated primary ductal carcinomas in situ ( DCIS ) of the breast and their local recurrences after breast-conserving therapy ( BCT ) for histological characteristics and marker expression . Patients who were r and omized in the EORTC trial 10853 ( wide local excision versus excision plus radiotherapy ) and who developed a local recurrence were identified . Histology was review ed for 116 cases ; oestrogen and progesterone receptor status , and HER2/neu and p53 overexpression were assessed for 71 cases . Comparing the primary DCIS and the invasive or non-invasive recurrence , concordant histology was found in 62 % , and identical marker expression in 63 % . Although 11 % of the recurrences developed at a distance from the primary DCIS , nearly all these showed the same histological and immunohistochemical profile . 5 patients developed well-differentiated DCIS or grade I invasive carcinoma after poorly differentiated DCIS . Although these recurrences occurred in the same quadrant as the primary DCIS , they may be considered as second primary tumours . Only 4 patients developed poorly differentiated DCIS or grade III invasive carcinoma after well differentiated DCIS . We conclude that in most cases the primary DCIS and its local recurrence are related histologically or by marker expression , suggesting that local recurrence usually reflects outgrowth of residual DCIS ; progression of well differentiated DCIS towards poorly differentiated DCIS or grade III invasive carcinoma is a non-frequent event . © 2001 Cancer Research PURPOSE N-(4-hydroxyphenyl ) retinamide ( ¿ 4-HPR , Fenretinide ; R.W. Johnson Pharmaceutical Research Institute , Springhouse , PA ) and tamoxifen ( TAM ) have synergistic antitumor and chemopreventive activity against mammary cancer in pre clinical studies . We performed a pilot study of this combination in women at high risk for developing breast cancer . PATIENTS AND METHODS Thirty-two women were treated with four cycles of 4-HPR , 200 mg orally ( PO ) for 25 days of each 28-day cycle , and TAM , 20 mg PO once daily for 23 months beginning after 1 month of 4-HPR alone . Tolerability , dark adaptometry , tissue biopsies , and retinoid plasma concentrations ( Cp ) were evaluated . RESULTS Symptomatic reversible nyctalopia developed in two patients ( 6 % ) on 4-HPR , but 16 ( 73 % ) of 22 patients had reversible changes in dark adaptation , which correlated with relative decrease in Cp retinol ( P < /=.01 ) . Four patients stopped treatment for side effects , and 84 % of patients had hot flashes . Other commonly reported ( grade < /= 2 ) reversible toxicities included skin and ocular dryness , fatigue , and mood changes . Serum high-density lipoprotein increased and cholesterol decreased from baseline to month 4 . Baseline mean + /- SD Cp retinol was 708 + /- 280 ng/mL. Mean + /- SD Cp of 4-HPR , N-(4-methoxyphenyl ) retinamide ( 4-MPR ) , and retinol after 1 month of 4-HPR were 0.34 + /- 0.21 micromol/L , 0.28 + /- 0.21 micromol/L , and 282 + /- 127 ng/mL , respectively . Mean retinoid Cps did not change after 3 months of 4-HPR + TAM . CONCLUSIONS TAM administration did not affect Cp 4-HPR or 4-MPR . Reversible nyctalopia correlated with relative decrease in Cp retinol but was not symptomatic for most patients . TAM + 4-HPR has acceptable tolerability for this high-risk cohort BACKGROUND Initial results from the first International Breast Cancer Intervention Study ( IBIS-I ) found that tamoxifen reduced the risk of invasive estrogen receptor (ER)-positive tumors by 31 % in women at increased risk for breast cancer , but most of the follow-up at this time was during the active treatment phase . We report an up date d analysis of IBIS-I that focuses on the period after active treatment was completed , a time for which little evidence from other trials is available . METHODS A total of 7145 women who were aged 35 - 70 years and at increased risk of breast cancer were r and omly assigned to receive either tamoxifen ( 20 mg/day ) or placebo for 5 years . The primary outcome measure was the incidence of breast cancer ( including ductal carcinoma in situ ) , but side effects were also investigated . Relative risks were computed as the ratio of incidence rates . All statistical tests were two-sided . RESULTS After a median follow-up of 96 months after r and omization , 142 breast cancers were diagnosed in the 3579 women in the tamoxifen group and 195 in the 3575 women in the placebo group ( 4.97 versus 6.82 per 1000 woman-years , respectively ; risk ratio [ RR ] = 0.73 , 95 % confidence interval [ CI ] = 0.58 to 0.91 , P = .004 ) . The prophylactic effect of tamoxifen was fairly constant for the entire follow-up period , and no diminution of benefit was observed for up to 10 years after r and omization . However , side effects in the tamoxifen group were much lower after completion of the active treatment period than during active treatment . For example , deep-vein thrombosis and pulmonary embolism were statistically significantly higher in the tamoxifen arm than in the placebo arm during active treatment ( 52 versus 23 cases , RR = 2.26 , 95 % CI = 1.36 to 3.87 ) but not after tamoxifen was stopped ( 16 versus 14 cases , RR = 1.14 , 95 % CI = 0.52 to 2.53 ) . The two arms did not differ in the risk of ER-negative invasive tumors ( 35 in each arm , RR = 1.00 , 95 % CI = 0.61 to 1.65 ) across the entire follow-up period , but the risk of ER-positive invasive breast cancer
Output:
| While tamoxifen after local excision for DCIS ( with or without adjuvant radiotherapy ) reduced the risk of recurrent DCIS ( in the ipsi- and contralateral breast ) , it did not reduce the risk of overall mortality |
MS213126 | ***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 Febuxostat , a novel nonpurine selective inhibitor of xanthine oxidase , is a potential alternative to allopurinol for patients with hyperuricemia and gout . METHODS We r and omly assigned 762 patients with gout and with serum urate concentrations of at least 8.0 mg per deciliter ( 480 micromol per liter ) to receive either febuxostat ( 80 mg or 120 mg ) or allopurinol ( 300 mg ) once daily for 52 weeks ; 760 received the study drug . Prophylaxis against gout flares with naproxen or colchicine was provided during weeks 1 through 8 . The primary end point was a serum urate concentration of less than 6.0 mg per deciliter ( 360 micromol per liter ) at the last three monthly measurements . The secondary end points included reduction in the incidence of gout flares and in tophus area . RESULTS The primary end point was reached in 53 percent of patients receiving 80 mg of febuxostat , 62 percent of those receiving 120 mg of febuxostat , and 21 percent of those receiving allopurinol ( P<0.001 for the comparison of each febuxostat group with the allopurinol group ) . Although the incidence of gout flares diminished with continued treatment , the overall incidence during weeks 9 through 52 was similar in all groups : 64 percent of patients receiving 80 mg of febuxostat , 70 percent of those receiving 120 mg of febuxostat , and 64 percent of those receiving allopurinol ( P=0.99 for 80 mg of febuxostat vs. allopurinol ; P=0.23 for 120 mg of febuxostat vs. allopurinol ) . The median reduction in tophus area was 83 percent in patients receiving 80 mg of febuxostat and 66 percent in those receiving 120 mg of febuxostat , as compared with 50 percent in those receiving allopurinol ( P=0.08 for 80 mg of febuxostat vs. allopurinol ; P=0.16 for 120 mg of febuxostat vs. allopurinol ) . More patients in the high-dose febuxostat group than in the allopurinol group ( P=0.003 ) or the low-dose febuxostat group discontinued the study . Four of the 507 patients in the two febuxostat groups ( 0.8 percent ) and none of the 253 patients in the allopurinol group died ; all deaths were from causes that the investigators ( while still blinded to treatment ) judged to be unrelated to the study drugs ( P=0.31 for the comparison between the combined febuxostat groups and the allopurinol group ) . CONCLUSIONS Febuxostat , at a daily dose of 80 mg or 120 mg , was more effective than allopurinol at the commonly used fixed daily dose of 300 mg in lowering serum urate . Similar reductions in gout flares and tophus area occurred in all treatment groups OBJECTIVE To determine if lowering of serum uric acid ( SUA ) concentrations below 6 mg/dl or longer duration of lowered SUA will result in depletion of urate crystals from the knee joints and prevent further attacks of gout . METHODS A prospect i ve study was initiated 10 years ago at Philadelphia VA Medical Center to attempt to maintain SUA levels of patients with crystal proven gout at < 6.0 mg/dl . We recalled all 57 patients who were available during 1999 . Patients were divided into 2 groups : Group A , with SUA still > 6 mg/dl , and Group B , with SUA < or = 6 mg/dl . A knee joint aspirate was requested from all asymptomatic Group B patients and many in Group A. Aspirates were examined by polarized light microscopy for identification of crystals . RESULTS There were no differences between the groups in age , sex , duration of gout , or serum creatinine . Group A ( n = 38 ) had a mean of 6 attacks of gout for the recent year , those with tophi having the most frequent attacks . Among the 16 patients in this group who agreed to knee aspiration , monosodium urate ( MSU ) crystals were found in 14 , although they were asymptomatic at the time . Nineteen patients ( Group B ) were able to maintain serum urate levels < or = 6 mg/dl for > 12 months . Nearly half of them had no attack of gout for 2 or more years , with a mean of 1 attack in the last year for the whole group . Three patients in whom tophi were found did not have major flares of gout within the past year . Knee joint aspiration was done on 16 asymptomatic patients . Seven ( 44 % ) still had MSU crystals present in their knees . Patients in this group who were taking prophylactic colchicine did not differ with respect to the character of synovial fluid from those who had discontinued it for up to several years , although the frequency of attacks was less in those who continued colchicine . CONCLUSION A majority of patients were able to deplete urate crystal stores in their knee joint fluids when their SUA levels were kept to < or = 6 mg/dl for several years . The mechanisms for persistence in some patients , and whether such crystals have clinical implication s , are not known . Patients with chronic gout need serum urate concentrations to be kept low to prevent further attacks Introduction The purpose of this study was to compare urate-lowering ( UL ) efficacy and safety of daily febuxostat and allopurinol in subjects with gout and serum urate ( sUA ) ≥ 8.0 mg/dL in a six-month trial . Methods Subjects ( n = 2,269 ) were r and omized to febuxostat 40 mg or 80 mg , or allopurinol 300 mg ( 200 mg in moderate renal impairment ) . Endpoints included the proportion of all subjects with sUA < 6.0 mg/dL and the proportion of subjects with mild/moderate renal impairment and sUA < 6.0 mg/dL. Safety assessment s included blinded adjudication of each cardiovascular ( CV ) adverse event ( AE ) and death . Results Comorbidities included : renal impairment ( 65 % ) ; obesity ( 64 % ) ; hyperlipidemia ( 42 % ) ; and hypertension ( 53 % ) . In febuxostat 40 mg , febuxostat 80 mg , and allopurinol groups , primary endpoint was achieved in 45 % , 67 % , and 42 % , respectively . Febuxostat 40 mg UL was statistically non-inferior to allopurinol , but febuxostat 80 mg was superior to both ( P < 0.001 ) . Achievement of target sUA in subjects with renal impairment was also superior with febuxostat 80 mg ( 72 % ; P < 0.001 ) compared with febuxostat 40 mg ( 50 % ) or allopurinol ( 42 % ) , but febuxostat 40 mg showed greater efficacy than allopurinol ( P = 0.021 ) . Rates of AEs did not differ across treatment groups . Adjudicated ( APTC ) CV event rates were 0.0 % for febuxostat 40 mg and 0.4 % for both febuxostat 80 mg and allopurinol . One death occurred in each febuxostat group and three in the allopurinol group . Conclusions Urate-lowering efficacy of febuxostat 80 mg exceeded that of febuxostat 40 mg and allopurinol ( 300/200 mg ) , which were comparable . In subjects with mild/moderate renal impairment , both febuxostat doses were more efficacious than allopurinol and equally safe . At the doses tested , safety of febuxostat and allopurinol was comparable . Clinical Trial Registration BACKGROUND Conflicting reports exist in the medical literature regarding the association between industry funding and published research findings . In this study , we examine the association between industry funding and the statistical significance of results in recently published medical and surgical trials . METHODS We examined a consecutive series of 332 r and omized trials published between January 1999 and June 2001 in 8 leading surgical journals and 5 medical journals . Each eligible study was independently review ed for method ological quality using a 21-point index with 5 domains : r and omization , outcomes , eligibility criteria , interventions and statistical issues . Our primary analysis included studies that explicitly identified the primary outcome and reported it as statistically significant . For studies that did not explicitly identify a primary outcome , we defined a " positive " study as one with at least 1 statistically significant outcome measure . We used multivariable regression analysis to determine whether there was an association between reported industry funding and trial results , while controlling for study quality and sample size . RESULTS Among the 332 r and omized trials , there were 158 drug trials , 87 surgical trials and 87 trials of other therapies . In 122 ( 37 % ) of the trials , authors declared industry funding . An unadjusted analysis of this sample of trials revealed that industry funding was associated with a statistically significant result in favour of the new industry product ( odds ratio [ OR ] 1.9 , 95 % confidence interval [ CI ] 1.3 - 3.5 ) . The association remained significant after adjustment for study quality and sample size ( adjusted OR 1.8 , 95 % CI 1.1 - 3.0 ) . There was a nonsignificant difference between surgical trials ( OR 8.0 , 95 % CI 1.1 - 53.2 ) and drug trials ( OR 1.6 , 95 % CI 1.1 - 2.8 ) , both of which were likely to have a pro-industry result ( relative OR 5.0 , 95 % CI 0.7 - 37.5 , p = 0.14 ) . INTERPRETATION Industry-funded trials are more likely to be associated with statistically significant pro-industry findings , both in medical trials and surgical interventions The diurnal change of sUA and the effect of febuxostat on this change were investigated in 10 patients with gout and /or hyperuricemia . The diurnal sUA change after the last dose during the 4‐week treatment phase ( 20 mg , QD ) was almost the same as the pre‐treatment value . Considering the dose , the AUCobs and C max of unchanged drug in patients with gout and /or hyperuricemia were estimated to be similar to those of healthy male adults . The results show that a 6‐week treatment with febuxostat is safe and well‐tolerated in the target patient population for this drug OBJECTIVE Gout affects approximately 1 - 2 % of the American population . Current options for treating hyperuricemia in chronic gout are limited . The purpose of this study was to assess the safety and efficacy of febuxostat , a nonpurine selective inhibitor of xanthine oxidase , in establishing normal serum urate ( sUA ) concentrations in gout patients with hyperuricemia ( > or=8.0 mg/dl ) . METHODS We conducted a phase II , r and omized , double-blind , placebo-controlled trial in 153 patients ( ages 23 - 80 years ) . Subjects received febuxostat ( 40 mg , 80 mg , 120 mg ) or placebo once daily for 28 days and colchicine prophylaxis for 14 days prior to and 14 days after r and omization . The primary end point was the proportion of subjects with sUA levels < 6.0 mg/dl on day 28 . RESULTS Greater proportions of febuxostat-treated patients than placebo-treated patients achieved an sUA level < 6.0 mg/dl at each visit ( P < 0.001 for each comparison ) . The targeted sUA level was attained on day 28 in 0 % of those taking placebo and in 56 % of those taking 40 mg , 76 % taking 80 mg , and 94 % taking 120 mg of febuxostat . The mean sUA reduction from baseline to day 28 was 2 % in the placebo group and 37 % in the 40-mg , 44 % in the 80-mg , and 59 % in the 120-mg febuxostat groups . Gout flares occurred with similar frequency in the placebo ( 37 % ) and 40-mg febuxostat ( 35 % ) groups and with increased frequency in the higher dosage febuxostat groups ( 43 % taking 80 mg ; 55 % taking 120 mg ) . During colchicine prophylaxis , gout flares occurred less frequently ( 8 - 13 % ) . Incidences of treatment-related adverse events were similar in the febuxostat and placebo groups . CONCLUSION Treatment with febuxostat result ed in a significant reduction of sUA levels at all dosages . Febuxostat therapy was safe and well tolerated Objective . To determine longterm urate-lowering efficacy and clinical benefits and safety of therapy with febuxostat or allopurinol in subjects with gout . Methods . Subjects ( n = 1086 ) in this open-label extension study were assigned to fixed-dose daily urate-lowering
Output:
| Although the incidence of gout flares requiring treatment may be increased in patients taking febuxostat compared to placebo or allopurinol during early treatment , no such increase in gout flares was observed in the long-term follow-up study when compared to allopurinol .
Febuxostat at any dose was shown to be beneficial in achieving serum uric acid levels < 6.0 mg/dL and reducing serum uric acid levels in the period from baseline to final visit when compared to placebo and to allopurinol . |
MS213127 | ***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: Goal Aim of this study is to assess the feasibility of substituting sodium phosphate ( NaP ) with polyethylene glycol (PEG)-boosters in the protocol preparation for PillCam Colon Capsule Endoscopy ( CCE ) . Background CCE represents a new diagnostic , endoscopic technology for colonic exploration . Bowel preparation for CCE is necessary not only to clean the colon , but also to promote capsule propulsion . For this reason , NaP boosters have been added to a 4 L PEG-preparation . NaP has been recently related with major side-effects . Study Forty patients were prospect ively r and omized to St and ard ( n=20 ) or Modified ( n=20 ) regimen . St and ard regimen included clear liquid diet , 4 L of PEG , and 1 or 2 NaP boosters . In the Modified regimen , NaP boosters were substituted by 1 or 2 PEG boosters ; 4 senna tablets and a low-residue diet were also included . Patients underwent CCE and conventional colonoscopy , carried out on the same day . CCE excretion rate , colon transit time , colon cleansing , and accuracy were evaluated . Results Hundred percent and 75 % of CCE were excreted with the St and ard and Modified regimen , respectively ( P=0.02 ) . Mean±SE colonic transit time of capsule was 2.17±1.43 hours in the St and ard group , and 5.32±2.53 hours in the Modified group ( P<0.001 ) . Adequate preparation was achieved in 42.5 % of the cases , without statistically significant difference between the 2 groups ( 35 % vs. 53 % ; P = NS ) . CCE sensitivity and specificity for ≥6 mm polyps were 63 % and 87 % , without difference between the 2 groups . Conclusions The exclusion of NaP booster from CCE preparation result ed into a clinical ly meaningful reduction of the capsule excretion rate that was only partially compensated by the PEG booster BACKGROUND AND STUDY AIMS Population -based screening for colorectal cancer is widely recommended , with conventional colonoscopy considered to be the preferred diagnostic modality . However , compliance with screening colonoscopy is low and manpower capacity is limited . Capsule endoscopy might therefore represent a desirable alternative strategy . PATIENTS AND METHODS The PillCam Colon capsule endoscope was prospect ively tested in a multicenter setting . The indications for endoscopy in the enrolled patients included colorectal cancer screening ( 43 % ) , postpolypectomy surveillance ( 26 % ) , and lower gastrointestinal signs and symptoms ( 31 % ) . Study subjects underwent colon preparation and then ingested the capsule on the morning of the examination , with conventional colonoscopy being performed the same day . The PillCam Colon capsule findings were review ed by three experts in capsule endoscopy who were blinded to the conventional colonoscopy findings . RESULTS A total of 91 subjects were enrolled in three Israeli centers ( 55 men , 36 women ; mean age 57 ) , and the results were evaluable in 84 cases . The capsule was excreted within 10 hours in 74 % of the patients and reached the rectosigmoid colon in the other 16 % . Of the 84 evaluable patients , 20 ( 24 % ) had significant findings , defined as at least one polyp of 6 mm or more in size or three or more polyps of any size : 14/20 ( 70 % ) were identified with the capsule and 16/20 ( 80 % ) were identified by conventional colonoscopy . Polyps of any size were found in 45 patients , 34/45 ( 76 % ) found by the capsule and 36/45 ( 80 % ) by conventional colonoscopy . In comparison with conventional colonoscopy , false-positive findings on PillCam Colon capsule examination were recorded in 15/45 cases ( 33 % ) . There were no adverse events related to the capsule endoscopy . CONCLUSIONS PillCam Colon capsule endoscopy appears to be a promising new modality for colonic evaluation . Further improvements in the procedure will probably increase capsule examination completion and polyp detection rates . Additional studies are needed to evaluate the accuracy of PillCam Colon endoscopy in other patient population s with different prevalence levels of colonic disease BACKGROUND & AIMS The efficacy of screening colonoscopy in first-degree relatives ( FDRs ) of patients with colorectal cancer ( CRC ) is limited by suboptimal uptake . We compared screening uptake of colon capsule endoscopy ( CCE ) vs colonoscopy in this population . METHODS We performed a prospect i ve study of 329 asymptomatic FDRs of patients with CRC who were r and omly assigned to groups examined by CCE ( PillCam , second generation ; n = 165 ) or colonoscopy ( n = 164 ) at a tertiary hospital in Spain from July 2012 through December 2013 . Crossover was permitted for patients who did not wish to undergo the assigned procedure . Subjects assigned to CCE who had a significant lesion ( polyp ≥ 10 mm , > 2 polyps of any size , or CRC ) were invited to undergo colonoscopy . RESULTS One hundred twenty subjects in the CCE group and 113 in the colonoscopy group were eligible for inclusion . In the intention-to-screen analysis , uptake was similar between groups ( 55.8 % CCE vs 52.2 % colonoscopy ; odds ratio [ OR ] , 0.86 ; 95 % confidence interval [ CI ] , 0.51 - 1.44 ; P = .57 ) ; 57.4 % of subjects crossed over from the CCE group , and 30.2 % crossed over from the colonoscopy group ( OR , 3.11 ; 95 % CI , 1.51 - 6.41 ; P = .002 ) . Unwillingness to repeat bowel preparation in the case of a positive result was the main reason that subjects assigned to the CCE group crossed over ; fear of colonoscopy was the reason that most patients in this group crossed over . A significant lesion was detected in 14 subjects ( 11.7 % ) in the CCE group and 13 subjects ( 11.5 % ) in the colonoscopy group ( OR , 1.02 ; 95 % CI , 0.45 - 2.26 ; P = .96 ) . CONCLUSIONS In a prospect i ve study , similar numbers of FDRs of patients with CRC assigned to undergo CCE or colonoscopy agreed to participate , but most preferred to undergo colonoscopy . CCE was as effective as colonoscopy in detecting significant lesions ; it could be a valid rescue strategy for subjects who reject screening colonoscopy . Clinical Trials.gov number : NCT01557101 Background Colonoscopy ( CSPY ) for colorectal cancer screening has several limitations . Colon Capsule Endoscopy ( PillCam Colon , CCE ) was compared to CSPY under routine screening conditions . Methods We performed a prospect i ve , single-center pilot study at a University Hospital . Data were obtained from November 2007 until May 2008 . Patients underwent CCE on Day 1 and CSPY on Day 2 . Outcomes were evaluated regarding sensitivity and specificity of polyp detection rate , with a significance level set at > 5 mm . Results 59 individuals were included in this study , the results were evaluable in 56 patients ( males 34 , females 22 ; median age 59 ) . CCE was complete in 36 subjects . Polyp detection rate for significant polyps was 11 % on CSPY and 27 % on CCE.6/56 ( 11 % ) patients had polyps on CSPY not detected on CCE ( miss rate).Overall sensitivity was 79 % ( 95 % confidence interval [ CI ] , 61 to 90 ) , specificity was 54 % ( 95 % CI , 35 to 70 ) , positive predictive value ( PPV ) was 63 % and negative predictive value ( NPV ) was 71 % . Adjusted to significance of findings , sensitivity was 50 % ( 95 % CI , 19 to 81 ) , specificity was 76 % ( 95 % CI , 63 to 86 ) , PPV was 20 % and NPV was 93 % . Conclusion In comparison to the gold st and ard , the sensitivity of CCE for detection of relevant polyps is low , however , the high NPV supports its role as a possible screening tool . Trial Registration NCT00991003 BACKGROUND Colon capsule endoscopy ( CCE ) is a new procedure for colon imaging . Limited information is available regarding visualization of flat colon lesions and patient acceptability in Japan . OBJECTIVE The aims of this study were to evaluate the sensitivity of CCE in detecting polyps and other lesions compared with optical colonoscopy ( OC ) and to evaluate its safety and acceptability in a cohort of Japanese patients . DESIGN A prospect i ve , open-label , clinical study in Japan . SETTING Multicenter . PATIENTS Patients referred for OC because of personal history of polyps ≥6 mm or any other colon lesion that required endoscopic or surgical treatment . INTERVENTIONS CCE followed by therapeutic colonoscopy . MAIN OUTCOME MEASUREMENTS The primary endpoint was per-patient sensitivity of CCE in detecting significant colon lesion . The secondary endpoints were CCE safety and patient acceptability . RESULTS Sixty-six of the 72 patients enrolled in the study were evaluated for efficacy . The per-patient sensitivity was 94 % ( 95 % confidence interval [ CI ] , 88.2%-99.7 % ) . The per-polyp sensitivity was 86.6 % ( 95 % CI , 81.3%-91.9 % ) when pathology-confirmed polyps were considered true positives . There were no adverse events related to CCE , and the acceptability of CCE was high . LIMITATIONS All patients had previously confirmed colon lesions , which may have falsely elevated the sensitivity of CCE . CONCLUSION CCE had a high sensitivity for detecting significant colon lesions . CCE was safe and had a high level of patient acceptability . ( CLINICAL TRIAL REGISTRATION NUMBER University Hospital Medical Information Network , UMIN000007258 . ) BACKGROUND & AIMS Capsule colonoscopy is a minimally invasive imaging method . We measured the accuracy of this technology in detecting polyps 6 mm or larger in an average-risk screening population . METHODS In a prospect i ve study , asymptomatic subjects ( n = 884 ) underwent capsule colonoscopy followed by conventional colonoscopy ( the reference ) several weeks later , with an endoscopist blinded to capsule results , at 10 centers in the United States and 6 centers in Israel from June 2011 through April 2012 . An unblinded colonoscopy was performed on subjects found to have lesions 6 mm or larger by capsule but not conventional colonoscopy . RESULTS Among the 884 subjects enrolled , 695 ( 79 % ) were included in the analysis of capsule performance for all polyps . There were 77 exclusions ( 9 % ) for inadequate cleansing and whole-colon capsule transit time fewer than 40 minutes , 45 exclusions ( 5 % ) before capsule ingestion , 15 exclusions ( 2 % ) after ingestion and before colonoscopy , and 15 exclusions ( 2 % ) for site termination . Capsule colonoscopy identified subjects with 1 or more polyps 6 mm or larger with 81 % sensitivity ( 95 % confidence interval [ CI ] , 77%-84 % ) and 93 % specificity ( 95 % CI , 91%-95 % ) , and polyps 10 mm or larger with 80 % sensitivity ( 95 % CI , 74%-86 % ) and 97 % specificity ( 95 % CI , 96%-98 % ) . Capsule colonoscopy identified subjects with 1 or more conventional adenomas 6 mm or larger with 88 % sensitivity ( 95 % CI , 82%-93 ) and 82 % specificity ( 95 % CI , 80%-83 % ) , and 10 mm or larger with 92 % sensitivity ( 95 % CI , 82%-97 % ) and 95 % specificity ( 95 % CI , 94%-95 % ) . Sessile serrated polyps and hyperplastic polyps accounted for 26 % and 37 % , respectively , of false-negative findings from capsule analyses . CONCLUSIONS In an average-risk screening population , technically adequate capsule colonoscopy identified individuals with 1 or more conventional adenomas 6 mm or larger with 88 % sensitivity and 82 % specificity . Capsule performance seems adequate for patients who can not undergo colonoscopy or who had incomplete colonoscopies . Additional studies are needed to improve capsule detection of serrated lesions . Clinical trials.gov number : NCT01372878 Objective In case of incomplete colonoscopy , several radiologic methods have traditionally been used , but more recently , capsule endoscopy was also shown to be accurate . Aim of this study was to compare colon capsule endoscopy ( CCE ) and CT colonography ( CTC ) in a prospect i ve cohort of patients with incomplete colonoscopy . Design Consecutive patients with a previous incomplete colonoscopy underwent CCE and CTC followed by colonoscopy in case of positive findings on either test ( polyps/mass lesions ≥6 mm ) . Clinical follow-up was performed in the other cases to rule
Output:
| The sensitivity in detection of polyps > 6 mm and > 10 mm increased substantially between development of first-generation and second-generation colon capsules .
High specificity values for detection of polyps by CCE-2 seem to be achievable with a 10-mm cutoff and in a screening setting |
MS213128 | ***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 A subset of fibromyalgia ( FM ) patients have a dysfunctional hypothalamic-pituitary-insulin-like growth factor 1 ( IGF-1 ) axis , as evidence d by low serum levels of IGF-1 and a reduced growth hormone ( GH ) response to physiologic stimuli . There is evidence that pyridostigmine ( PYD ) improves the acute response of GH to exercise in FM patients . The purpose of this study was to evaluate the clinical effectiveness of 6 months of PYD and group exercise on FM symptoms . METHODS FM patients were r and omized to 1 of the following 4 groups : PYD plus exercise , PYD plus diet recall but no exercise , placebo plus exercise , and placebo plus diet recall but no exercise . The primary outcome measures were the visual analog scale ( VAS ) score for pain , tender point count , and total myalgic score . Secondary outcome measures were the total score on the Fibromyalgia Impact Question naire ( FIQ ) and FIQ VAS scores for individual symptoms ( fatigue , poor sleep , stiffness , and anxiety ) , as well as quality of life ( QOL ) and physical fitness ( lower body strength/endurance , upper and lower body flexibility , balance , and time on the treadmill ) . RESULTS A total of 165 FM patients completed baseline measurements ; 154 ( 93.3 % ) completed the study . The combination of PYD and exercise did not improve pain scores . PYD groups showed a significant improvement in sleep and anxiety in those who completed the study and in QOL in those who complied with the therapeutic regimen as compared with the placebo groups . Compared with the nonexercise groups , the 2 exercise groups demonstrated improvement in fatigue and fitness . PYD was generally well tolerated . CONCLUSION Neither the combination of PYD plus supervised exercise nor either treatment alone yielded improvement in most FM symptoms . However , PYD did improve anxiety and sleep , and exercise improved fatigue and fitness . We speculate that PYD may have improved vagal tone , thus benefiting sleep and anxiety ; this notion warrants further study A h and exerciser with an electronic counter and a visual display was used to measure compliance objective ly , to investigate the effects of visual feedback on compliance , and to assess the impact of exercise on seven mild and five moderate rheumatoid arthritis patients . A multiple time-series design varying the onset of the visual display was utilized . Compliance was assessed weekly over the 7 weeks of the study . Pretest and posttest measures of various indicators of h and functioning were taken by an occupational therapist . Visual display of the number of exercises completed decreased the number of noncompliant patients from six to two , with the maximum degree of noncompliance reduced from 44 to 5 % . Thus the use of visual display is effective in producing compliance to exercise regimens . In light of the small sample size , however , no definitive conclusions can be drawn regarding the effects of exercise on h and functioning Adjustments for making multiple comparisons in large bodies of data are recommended to avoid rejecting the null hypothesis too readily . Unfortunately , reducing the type I error for null associations increases the type II error for those associations that are not null . The theoretical basis for advocating a routine adjustment for multiple comparisons is the “ universal null hypothesis ” that “ chance ” serves as the first-order explanation for observed phenomena . This hypothesis undermines the basic premises of empirical research , which holds that nature hollows regular laws that may he studied through observations . A policy of not making adjustments for multiple comparisons is preferable because it will lead to fewer errors of interpretation when the data under evaluation are not r and om numbers but actual observations on nature . Furthermore , scientists should not he so reluctant to explore leads that may turn out to he wrong that they penalize themselves by missing possibly important findings OBJECTIVE To evaluate the feasibility of 8 months of supervised exercise therapy in warm water and its effects on the impact of fibromyalgia on physical and mental health and physical fitness in affected women . METHODS Thirty women with fibromyalgia were r and omly assigned to an exercise therapy group ( n = 15 ) or a control group ( inactive ) ( n = 15 ) . The impact of fibromyalgia on physical and mental health was assessed using the Fibromyalgia Impact Question naire and the anxiety state with State-Trait Anxiety Inventory . Physical fitness was measured using the following tests : Canadian Aerobic Fitness ; h and -grip dynamometry ; 10-metre walking ; 10-step stair-climbing and blind 1-leg stance . RESULTS After 8 months of training , the exercise therapy group improved compared with the control group in terms of physical function ( 20 % ) , pain ( 8 % ) , stiffness ( 53 % ) , anxiety ( 41 % ) , depression ( 27 % ) , Fibromyalgia Impact Question naire total scores ( 18 % ) , State-Trait Anxiety Inventory score ( 22 % ) , aerobic capacity ( 22 % ) , balance ( 30 % ) , functional capacity for walking ( 6 % ) , stair-climbing with no extra weight ( 14 % ) and stair-climbing 10 kg-weighted ( 25 % ) . CONCLUSION Eight months of supervised exercise in warm water was feasible and led to long-term improvements in physical and mental health in patients with fibromyalgia at a similar magnitude to those of shorter therapy programmes To compare the use of r and omized controls ( RCTs ) and historical controls ( HCTs ) for clinical trials , we search ed the literature for therapies studied by both methods . We found six therapies for which 50 RCTs and 56 HCTs were reported . Forty-four of 56 HCTs ( 79 percent ) found the therapy better than the control regimen , but only 10 of 50 RCTs ( 20 percent ) agreed . For each therapy , the treated patients in RCTs and HCTs of the same therapy was largely due to differences in outcome for the control groups , with HCT control patients generally doing worse than the RCT control groups . Adjustment of the outcomes of the HCTs for prognostic factors , when possible , did not appreciably change the results . The data suggest that biases in patient selection may irretrievably weight the outcome of HCts in favor of new therapies . RCTs may miss clinical ly important benefits because of inadequate attention to sample size . The predictive value of each might be improved by reconsidering the use of p less than 0.05 as the significance level for all types of clinical trials , and by the use of confidence intervals around estimates of treatment effects This study addressed a method ological gap by comparing psychological and social outcomes of exercise in green outdoors versus built indoors setting s , whilst rigorously controlling exercise mode and intensity . The hypotheses were that greater improvements or more desirable values for directed attention , mood , perceived exertion , social interaction time , intention for future exercise behaviour and enjoyment would be associated with outdoors compared to indoors exercise . Following a baseline session , paired participants completed two conditions of 15 min of cycling on an ergometer placed outside in a natural environment and inside in a laboratory setting in a r and omized , counter-balanced order . At pre- and post-exercise , directed attention was measured with the digit span backwards task , and mood was assessed with the Profile of Mood States . During the exercise session , visual and verbal interactions were recorded by means of experimenter observations . After each exercise session , participants provided self-reports of their enjoyment of the exercise , perceived exertion and intention for future exercise in the same environment . Social interaction time was significantly greater during outdoors exercise versus indoors ; on average , participants engaged in three minutes more social interaction during exercise outdoors compared to indoors . Social interaction time significantly predicted intention for future exercise in the outdoors condition , but did not in the indoor condition . There was a significant time by condition interaction for directed attention . Scores worsened in the indoors condition , but improved in the outdoors condition . There was no statistically-significant time by condition interaction for mood and no significant difference between conditions for either perceived exertion or intention . Taken together , these findings show that exercise in a natural environment may promote directed attention and social interactions , which may positively influence future exercise intentions BACKGROUND AND PURPOSE The purpose s of this study were : ( 1 ) to assess the effectiveness of a 16-week progressive program of home-based , videotape-based , low-impact aerobic exercise on physical function and signs and symptoms of fibromyalgia in previously sedentary women aged 20 to 55 years and ( 2 ) to compare the effects of 1 long exercise bout versus 2 short exercise bouts per training day ( fractionation ) on physical function , signs and symptoms of fibromyalgia , and exercise adherence . SUBJECTS One hundred forty-three sedentary women were r and omly assigned to 1 of 3 groups : a group who trained using a long bout of exercise ( LBE group , n=51 ) , a group who trained using short bouts of exercise ( SBE group , n=56 ) , and a group who performed no exercise ( NE group , n=36 ) . METHODS The SBE group exercised twice daily , and the LBE group worked out once daily . Both groups progressed in total daily training duration from 10 to 30 minutes , 3 to 5 times a week , for 16 weeks . Physical and psychological well-being , symptoms , and self-efficacy were evaluated using a multivariate analysis of variance . RESULTS Dropout rates for the NE , SBE , and LBE groups were 14 % , 38 % , and 29 % , respectively . The NE group differed from the LBE group in disease severity , self-efficacy , and psychological well-being ( midtest , efficacy analysis ) and from the SBE group in disease severity and self-efficacy ( posttest , efficacy analysis ) . Exercise adherence was greater for the LBE group than for the SBE group between weeks 5 and 8 of the training program . No other differences between exercise groups were found . DISCUSSION AND CONCLUSION Progressive , home-based , low-impact aerobics improved physical function and fibromyalgia symptoms minimally in participants who completed at least two thirds of the recommended exercise . Fractionation of exercise training provided no advantage in terms of exercise adherence , improvements in fibromyalgia symptoms or physical function . High attrition rates and problems with exercise adherence were experienced in both exercise groups OBJECTIVES To evaluate the effects of a 16-week exercise therapy in a chest-high pool of warm water through applicable tests in the clinical practice on the global symptomatology of women with fibromyalgia ( FM ) and to determine exercise adherence levels . DESIGN A r and omized controlled trial . SETTING Testing and training were completed at the university . PARTICIPANTS Middle-aged women with FM ( n=60 ) and healthy women ( n=25 ) . INTERVENTION A 16-week aquatic training program , including strength training , aerobic training , and relaxation exercises . MAIN OUTCOME MEASURES Tender point count ( syringe calibrated ) , health status ( Fibromyalgia Impact Question naire ) ; sleep quality ( Pittsburgh Sleep Quality Index ) ; physical ( endurance strength to low loads tests ) , psychologic ( State Anxiety Inventory ) , and cognitive function ( Paced Auditory Serial Addition Task ) ; and adherence 12 months after the completion of the study . RESULTS For all the measurements , the patients showed significant deficiencies compared with the healthy subjects . Efficacy analysis ( n=29 ) and intent-to-treat analysis ( n=34 ) of the exercise therapy was effective in decreasing the tender point count and improving sleep quality , cognitive function , and physical function . Anxiety remained unchanged during the follow-up . The exercise group had a significant improvement of health status , not associated exclusively with the exercise intervention . There were no changes in the control group . Twenty-three patients in the exercise group were exercising regularly 12 months after completing the program . CONCLUSIONS An exercise therapy 3 times a week for 16 weeks in a warm pool could improve most of the symptoms of FM and cause a high adherence to exercise in unfit women with heightened FM symptomatology . The therapeutic intervention 's effects can be assessed through applicable tests in the clinical practice OBJECTIVES To examine the effects of a supervised aerobic exercise programme on heart rate variability ( HRV ) parameters and symptom severity in women with fibromyalgia ( FM ) . METHODS Thirty-two women with FM were r and omly allocated to one of two groups : aerobic exercise ( AE ) or usual care control for 24 weeks . Women allocated to AE performed two aerobic exercise sessions per week of 45 - 60 min duration including 15 - 20 min of steady-state aerobic exercise at 60 - 65 % of predicted maximum heart rate ( HRmax ) and 15 min of interval training at 75 - 80 % HRmax ( six repetitions of 1.5 min , with 1 min interpolated rest intervals ) . Cardiac autonomic modulation was assessed using power spectral analysis of HRV . Symptom severity was assessed by a 10 cm visual analogue scale ( VAS ) for pain , sleep disturbances , stiffness , anxiety and depression . RESULTS After 24 weeks , the women in the exercise group showed an increase ( 4.8 ± 0.2 to 5.2 ± 0.2 ) in total power ( LnTP , p<0.001 ) , low frequency power ( LnLF , p<0.01 ) , high frequency power ( LnHF , p<0.001 ) , and the root-mean-square of successive R-R intervals ( rMSSD , p<0.001 ) . In addition , significant group-by-time interaction effects were observed for LnHF ( p=0.036 ) and LnLF/HF ( p=0.014 ) . Improvements in anxiety and depression were also observed in AE versus control patients . CONCLUSIONS These results show that a programme of aerobic exercise training induced changes in cardiac autonomic nervous system modulation in FM and that these changes in HRV parameters were accompanied by changes in anxiety
Output:
| CONCLUSIONS Exercise is associated with reductions in anxiety among adults with selected types of AORD . |
MS213129 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE The 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 PURPOSE To assess the relationships between player characteristics ( including age , playing experience , ethnicity , and physical fitness ) and in-season injury in elite Australian football . DESIGN Single-cohort , prospect i ve , longitudinal study . METHODS Player characteristics ( height , body mass , age , experience , ethnicity , playing position ) , preseason fitness ( 6-min run , 40-m sprint , 6 × 40-m sprint , vertical jump ) , and in-season injury data were collected over 4 seasons from 1 professional Australian football club . Data were analyzed for 69 players , for a total of 3879 player rounds and 174 seasons . Injury risk ( odds ratio [ OR ] ) and injury severity ( matches missed ; rate ratio [ RR ] ) were assessed using a series of multilevel univariate and multivariate hierarchical linear models . RESULTS A total of 177 injuries were recorded with 494 matches missed ( 2.8±3.3 matches/injury ) . The majority ( 87 % ) of injuries affected the lower body , with hamstring ( 20 % ) and groin/hip ( 14 % ) most prevalent . Nineteen players ( 28 % ) suffered recurrent injuries . Injury incidence was increased in players with low body mass ( OR=0.887 , P=.005 ) , with poor 6-min-run performance ( OR=0.994 , P=.051 ) , and playing as forwards ( OR=2.216 , P=.036 ) . Injury severity was increased in players with low body mass ( RR=0.892 , P=.008 ) , tall stature ( RR=1.131 , P=.002 ) , poor 6-min-run ( RR=0.990 , P=.006 ) , and slow 40-m-sprint ( RR=3.963 , P=.082 ) performance . CONCLUSIONS The potential to modify intrinsic risk factors is greatest in the preseason period , and improvements in aerobic-running fitness and increased body mass may protect against in-season injury in elite Australian football Talent identification ( TID ) is a pertinent component of the sports sciences , affording practitioners the opportunity to target developmental interventions to a select few ; optimising financial investments . However , TID is multi-componential , requiring the recognition of immediate and prospect i ve performance . The measurement of athletic movement skill may afford practitioners insight into the latter component given its augmented relationship with functional sport specific qualities . It is currently unknown whether athletic movement skill is a discriminant quality in junior Australian football ( AF ) . This study aim ed to discriminate talent identified junior AF players from their non-talent identified counterparts using a fundamental gross athletic movement assessment . From a total of 50 under 18 ( U18 ) AF players ; two groups were classified a priori based on selection level ; talent identified ( n = 25 ; state academy representatives ) and non-talent identified ( n = 25 ; state-based competition representatives ) . Players performed a fundamental gross athletic movement assessment based on the Athletic Ability Assessment ( AAA ) , consisting of an overhead squat , double lunge ( left and right legs ) , single leg Romanian deadlift ( left and right legs ) , and a push up ( six movement criterions ) . Movements were scored across three assessment points using a three-point scale ( result ing in a possible score of nine for each movement ) . A multivariate analysis of variance revealed significant between group effects on four of the six movement criterions ( d = 0.56 - 0.87 ; p = 0.01 - 0.02 ) . Binary logistic regression models and a receiver operating characteristic curve inspection revealed that the overhead squat score provided the greatest group discrimination ( β(SE ) = -0.89(0.44 ) ; p < 0.05 ) , with a score of 4.5 classifying 64 % and 88 % of the talent identified and non-talent identified groups , respectively . Results support the integration of this assessment into contemporary talent identification approaches in junior AF , as it may provide coaches with insight into a juniors developmental potential Objective : To evaluate the effectiveness of a preseason physical training programme that taught l and ing and falling skills in improving l and ing skills technique and preventing injury in junior elite Australian football players . Methods : 723 male players who participated in an under 18 elite competition were studied prospect ively in a non-r and omised controlled trial over two consecutive football seasons . There were 114 players in the intervention group and 609 control players . The eight session intervention programme taught players six l and ing , falling , and recovery skills , which were considered fundamental for safe l and ing in Australian football . L and ing skills taught in these sessions were rated for competence by independent and blinded assessors at baseline and mid-season . Results : Evaluation of l and ing skills found no significant differences between the groups at baseline . Evaluation after the intervention revealed overall improvement in l and ing skills , but significantly greater improvement in the intervention group ( z = −7.92 , p = 0.001 ) . Players in the intervention group were significantly less likely ( relative rate 0.72 , 95 % confidence interval 0.52 to 0.98 ) to sustain an injury during the season than the control group . In particular , the time to sustaining a l and ing injury was significantly less for the intervention group ( relative rate 0.40 , 95 % confidence interval 0.17 to 0.92 ) compared with the control group . Conclusions : L and ing and falling ability can be taught to junior elite Australian football players . Players in the intervention group were protected against injury , particularly injuries related to l and ing and falls Abstract Gaudion , SL , Doma , K , Sinclair , W , Banyard , HG , and Woods , CT . Identifying the physical fitness , anthropometric and athletic movement qualities discriminant of developmental level in elite junior Australian football : implication s for the development of talent . J Strength Cond Res 31(7 ) : 1830–1839 , 2017—This study aim ed to identify the physical fitness , anthropometric and athletic movement qualities discriminant of developmental level in elite junior Australian football ( AF ) . From a total of 77 players , 2 groups were defined according to their developmental level ; under 16 ( U16 ) ( n = 40 , 15.6 to 15.9 years ) , and U18 ( n = 37 , 17.1 to 17.9 years ) . Players performed a test battery consisting of 7 physical fitness assessment s , 2 anthropometric measurements , and a fundamental athletic movement assessment . A multivariate analysis of variance tested the main effect of developmental level ( 2 levels : U16 and U18 ) on the assessment criterions , whilst binary logistic regression models and receiver operating characteristic ( ROC ) curves were built to identify the qualities most discriminant of developmental level . A significant effect of developmental level was evident on 9 of the assessment s ( d = 0.27–0.88 ; p ⩽ 0.05 ) . However , it was a combination of body mass , dynamic vertical jump height ( nondominant leg ) , repeat sprint time , and the score on the 20-m multistage fitness test that provided the greatest association with developmental level ( Akaike 's information criterion = 80.84 ) . The ROC curve was maximized with a combined score of 180.7 , successfully discriminating 89 and 60 % of the U18 and U16 players , respectively ( area under the curve = 79.3 % ) . These results indicate that there are distinctive physical fitness and anthropometric qualities discriminant of developmental level within the junior AF talent pathway . Coaches should consider these differences when design ing training interventions at the U16 level to assist with the development of prospect i ve U18 AF players Hamstring muscle strain is the most prevalent injury in Australian Rules Football , accounting for 16 % of play ing time missed as a result of injury . Thirty-seven pro fessional footballers from an Australian Football League team had preseason measurements of ham string and quadriceps muscle concentric peak torque at 60 , 180 , and 300 deg/sec measured on a Cybex 340 dynamometer . Players were studied prospect ively throughout the 1995 season . During that time , six play ers sustained clinical ly diagnosed hamstring muscle injuries that caused them to miss match-playing time . The injured hamstring muscles were all weaker than in the opposite leg in absolute values and hamstring-to- quadriceps muscle ratios . According to our t-test re sults , hamstring muscle injury was significantly asso ciated with a low hamstring-to-quadriceps muscle peak torque ratio at 60 deg/sec on the injured side and a low hamstring muscle side-to-side peak torque ratio at 60 deg/sec . Flexibility ( as measured by the sit- and -reach test ) did not correlate with injury . Discriminant-function analysis using the two significant ratio variables re sulted in a canonical correlation with injury of 0.4594 and correctly classified legs into injury groups with 77.4 % success . These results indicate that preseason isokinetic testing of professional Australian Rules foot ballers can identify players at risk of developing ham string muscle strains Purpose Knowledge of aerobic performance capacity allows for the optimisation of training programs in aerobically dominant sports . Maximal aerobic speed ( MAS ) is a measure of aerobic performance ; however , the time and personnel dem and s of establishing MAS are considerable . This study aim ed to determine whether time-trials ( TT ) , which are shorter and less onerous than traditional MAS protocol s , may be used to predict MAS . Methods 28 Australian Rules football players completed a test of MAS , followed by TTs of six different distances in r and om order , each separated by at least 48 h. Half of the participants completed TT distances of 1200 , 1600 and 2000 m , and the others completed distances of 1400 , 1800 and 2200 m. Results Average speed for the 1200 and 1400 m TTs were greater than MAS ( P < 0.01 ) . Average speed for 1600 , 1800 , 2000 and 2200 m TTs were not different from MAS ( P > 0.08 ) . Average speed for all TT distances correlated with MAS ( r = 0.69–0.84 ; P < 0.02 ) , but there was a negative association between the difference in average TT speed and MAS with increasing TT distance ( r = −0.79 ; P < 0.01 ) . Average TT speed over the 2000 m distance exhibited the best agreement with MAS . Conclusions MAS may be predicted from the average speed during a TT for any distance between 1200 and 2200 m , with 2000 m being optimal . Performance of a TT may provide a simple alternative to traditional MAS testing OBJECTIVES Australian Football ( AF ) is a collision sport containing high injury rates in junior competition . Successful performance at the elite junior level not only requires superior specific football knowledge and skills , but also well developed fitness qualities . However , no studies have examined the link between physical fitness qualities and injury in AF . DESIGN Prospect i ve cohort . METHODS Injury data were collected through the use of a Player Movement Record ( PMR ) and a st and ardized Injury Report Form ( IRF ) . Fitness test data was collected during the pre-season of the 2010 and 2011 seasons . RESULTS 382 players consented to participate in the study . The cohort experienced an injury incidence rate of 24.29/st and ardized club ( 40 players/club ) . A faster 5-m sprint was associated with ' injury status ' ( p=0.0
Output:
| Conclusions Talent pathway players exhibit similar mean test scores irrespective of the physical test , with the exception of 20-m sprint and VJ .
Physical tests can discriminate between local participation level players but are less useful within the AFL talent pathway |
MS213130 | ***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 Cryopreservation of embryos may lead to zona hardening that may compromise in vivo hatching and implantation following thawing and transfer . Assisted hatching ( AH ) has been advocated as a means of assisting the natural hatching process and enhancing implantation . METHODS The aim of this study was to assess in a prospect i ve r and omized manner the effect of laser-assisted hatching ( LAH ) on implantation as well as clinical and multiple pregnancy rates ( the primary outcome ) after the transfer of frozen-thawed embryos . All embryos were thawed the day before transfer , and LAH was performed the next day on embryos that cleaved . Control group consisted of embryos that were transferred without AH . RESULTS The performance of LAH significantly increased implantation ( 9.9 versus 20.1 % , P < 0.01 ) , clinical pregnancy ( 27.3 versus 40.9 , P < 0.05 ) and multiple pregnancy rates ( 16 versus 40.3 % , P < 0.07 ) . In the LAH group , significantly more excess embryos that were left in culture hatched in vitro . CONCLUSIONS LAH improves the outcome of frozen-thawed embryo transfer when performed before transfer on embryos that were allowed to cleave Abstract Purpose : The role of assisted hatching in good-prognosis IVF patients was evaluated in a prospect i ve , r and omized , controlled pilot study , which was followed by a retrospective observational series . Methods : After assisted hatching was proved successful in a mouse embryo study , 20 good-prognosis IVF patients were r and omly assigned to either assisted hatching ( 13 ) or no assisted hatching ( 7 ; the controls ) . Following this series , 27 good-prognosis IVF patients were retrospectively evaluated to determine the outcome with assisted hatching . Results : In the prospect i ve study , clinical pregnancies result ed from 3 ( 23 % ) of 13 patients in the hatching group , compared to 3 ( 43 % ) of 7 in the control group . Implantation rates were similar : 9.6 % in the hatching group and 10.7 % in the controls . In the retrospective series , the 11.1 % implantation rate with assisted hatching was significantly less than the 42.9 % implantation rate seen with traditional IVF . Conclusions : Implantation and pregnancy rates are high in young women undergoing traditional IVF . Assisted hatching is not beneficial in these patients OBJECTIVE To develop a new approach to partial zona dissection of oocytes and embryos for facilitating preimplantation genetic sampling and assisted hatching . DESIGN Controlled clinical study . SETTING Preimplantation genetic diagnosis and IVF program , Reproductive Genetics Institute/IVF Illinois , Chicago , Illinois . PATIENT(S ) Three hundred forty patients undergoing IVF in whom preimplantation genetic diagnosis or assisted hatching was required . INTERVENTION(S ) Three-dimensional partial zona dissection and conventional partial zona dissection were performed , with the use of a simple microneedle , on embryos before preimplantation genetic sampling or on day 3 of embryo development before ET . MAIN OUTCOME MEASURE(S ) Pregnancy rate , implantation rate , and ease of preimplantation genetic sampling . RESULT ( S ) A pregnancy rate of 42 % and an embryo implantation rate of 17.6 % were obtained in the group in which three-dimensional partial zona dissection was performed , compared with a pregnancy rate of 33 % and an implantation rate of 14.7 % in the control group , which underwent conventional partial zona dissection . Preimplantation genetic sampling can be performed without distortion of the blastomere configuration in the embryo . CONCLUSION ( S ) Three-dimensional partial zona dissection is a safe and simple mechanical means of creating an opening sufficient for the atraumatic removal of material from oocytes and embryos for preimplantation genetic diagnosis and assisted hatching Purpose The aim of this study was to determine if the size of zona pellucida thinning area by laser assisted hatching could affect the rates of pregnancy and implantation for vitrified-warmed embryo transfers at the cleavage-stage . Methods A total of 120 vitrified-warmed cleavage-stage embryo transfers were r and omly assigned to either quarter or half of zona pellucida thinning group . Results The rates of clinical pregnancy ( 46.7 versus 25.0 % ) and implantation ( 32.0 versus 16.2 % ) were significantly greater in the half thinning group than in the quarter thinning group ( P = 0.0218 and P = 0.0090 , respectively ) . Conclusions The results of this investigation show that , in vitrified-warmed embryo transfers at the cleavage-stage , the size of zona pellucida thinning area by laser assisted hatching impacts the rate of clinical pregnancy and implantation and that half of zona pellucida thinning significantly increases both of these results compared with quarter of zona pellucida thinning OBJECTIVE To assess the effect of augmenting IVF with assisted hatching in the treatment of patients with repeated IVF failures . DESIGN Prospect i ve r and omized study . SETTING Division of Reproductive Endocrinology and Infertility of National Taiwan University Hospital . PATIENT(S ) From July 1993 to February 1996 , 49 patients with repeatedly failed IVF were treated with assisted hatching and were compared with 51 control subjects without assisted hatching . INTERVENTION(S ) Assisted hatching . MAIN OUTCOME MEASURE(S ) Pregnancy rate and implantation rate per embryo after IVF-ET or IVF-tubal ET ( TET ) were measured . RESULT ( S ) The pregnancy rate ( PR ) in the assisted hatching group was found to be 36.7 % compared with 19.6 % in the control group , but the difference was not significant . When only patients receiving IVF-ET were considered , it was observed that the PR was significantly higher in the assisted hatching group than the control group ( 42.4 % versus 16.1 % ) . With IVF-TET however , the PR was found to be similar in both assisted hatching and control groups ( 25.0 % and 25.0 % , respectively ) . The rate of embryonic implantation in the IVF-ET patients was 11.0 % , which was significantly higher than that of control embryos ( 3.7 % ) . CONCLUSION ( S ) These results implied that IVF-ET , combined with assisted hatching , may improve the PR and implantation rate in patients with repeated IVF failures , but the same was not true in the case of IVF-TET In two separate prospect ively r and omized trials , intracytoplasmic sperm injection ( ICSI ) cycles were studied in a controlled manner to monitor the effects of either bovine oviductal epithelial cell co-culture ( n = 119 ) or assisted hatching by zona drilling ( n = 100 ) . In the first study , immediately following ICSI , all eggs were placed directly either onto partial monolayers of bovine oviductal cells or into regular culture medium . Although the embryo developmental rate was apparently compromised in part by the presence of the co-culture cells , ultimately there were no significant differences in either the viable pregnancy rate ( 31.6 % co-culture versus 29.0 % control ) or the embryonic implantation rate ( 11.4 % co-culture versus 13.6 % control ) . Assisted hatching also had no significant impact on ICSI cycle outcome in terms of either the viable pregnancy rate ( 30.0 % assisted hatching versus 32.0 % control ) or the embryonic implantation rate ( 8.5 % assisted hatching versus 13.5 % control ) . However , in female patients aged > or = 35 years , assisted hatching appeared to convey a marginally significant benefit in terms of both the viable pregnancy rate ( 35.5 % assisted hatching versus 11.1 % control ) and the embryonic implantation rate ( 10.3 % assisted hatching versus 3.1 % control ) . It seems that the overall improvement of ICSI cycle outcome can not be achieved by the general application of either co-culture or assisted hatching . Nevertheless , it is possible that there remain specific patient groups that might benefit from selected use of either of these modalities BACKGROUND Assisted hatching ( AH ) in fresh embryo transfer ( ET ) cycles increases the implantation and pregnancy rates , especially in women with a poor prognosis , repeated implantation failures and in older women . Little information exists in the literature regarding the role of AH in frozen-thawed embryo transfer ( FET ) cycles . METHODS Embryos were cryopreserved at the cleavage stage . On the day of FET , 160 patients were r and omized according to a computer-generated r and omization list in sealed envelopes into the AH group and the control group . The patients and the clinicians were blinded to the group assigned . In the AH group , the outer half of the zona pellucida over a quarter of the diameter of zona was removed using a 1480 nm non-contact laser . RESULTS The two groups were comparable in terms of demographic characteristics , ovarian response of the stimulated cycle and quality of fresh and frozen-thawed embryos . No differences in implantation , pregnancy and multiple pregnancy rates were found between the two groups . There was a non-significant trend of a higher implantation rate in the AH group when the zona thickness was > or = 16 mm . CONCLUSION Laser AH did not improve the implantation rate of FET cycles and should not be performed routinely in all frozen-thawed embryos at the cleavage stage OBJECTIVE To evaluate the overall effect of assisted hatching ( AH ) on the implantation , pregnancy , and live birth rates in women undergoing intracytoplasmic sperm injection ( ICSI ) cycles ; and to determine the effect of AH on the cytogenetic outcome ( chromosomal constitution ) of pregnancy . DESIGN Prospect i ve , r and omized study . SETTING Academic research environment . PATIENT(S ) A total of 172 couples were enrolled in the study . INTERVENTION(S ) Assisted hatching was carried out on day-3 ICSI embryos . MAIN OUTCOME MEASURE(S ) Implantation , clinical pregnancy , and live birth rates ; cytogenetic analysis of abortuses and umbilical cord blood sample s from newborns . RESULT ( S ) Biochemical , clinical , and ongoing pregnancy rates were not significantly different between the AH and control groups . The implantation rate was higher in the AH group than in the control group ( 16 % vs. 8 % ) , especially in women aged > or = 35 years . Postnatal umbilical cord blood sample s were collected and cytogenetically analyzed from 39 live births ( 20 from the AH group , 19 from the control group ) . Two abnormal karyotypes were found ( one AH , one control ) . There were seven spontaneous losses during the study interval . Six of the abortuses underwent cytogenetic study ( five AH , one control ) , and four were found to have an abnormal karyotype ( three AH , one control ) . CONCLUSION We found that AH improves implantation rates of ICSI cycles and seems to be most effective in women aged > or = 35 years . A larger sample size is needed to determine whether AH improves the take-home-baby rate . Assisted hatching did not affect the rate of chromosomal abnormalities in live births in this study OBJECTIVE The aims of this study were to compare preimplantation embryo quality in intracytoplasmic sperm injection ( ICSI ) with st and ard IVF and to examine the impact of age and number and quality of embryos transferred on implantation and pregnancy . DESIGN Retrospective , controlled clinical study . SETTING Academic tertiary center . PATIENT(S ) We examined 211 consecutive couples undergoing ICSI who were matched with 211 couples undergoing IVF therapy during the same time frame . INTERVENTION(S ) In vitro embryo culture . MAIN OUTCOME MEASURE(S ) Day 3 embryo quality as judged by the number of blastomeres and morphology scoring . RESULT ( S ) Patients undergoing ICSI had a significantly reduced number of embryos with good morphology and cleavage compared with IVF cases . Nevertheless , pregnancy and abortion rates were similar when adjusted by age and number of embryos transferred . Average cleavage status and age were significant predictors of implantation . Women of advanced age had significantly lower embryo cleavage and implantation rates . CONCLUSION ( S ) [ 1 ] The cleaving status of day 3 embryos is a valuable , although limited , indicator of implantation outcome . [ 2 ] In vitro fertilization-derived embryos had better cleavage rates and morphology scores than ICSI-derived embryos ; however , the implantation potential was similar for both groups . [ 3 ] The age-related decline in implantation rate was associated with impaired embryo growth rates BACKGROUND Assisted hatching ( AH ) in fresh embryo transfer ( ET ) could be associated with increased implantation rates . However , very few prospect i ve r and omized studies have specifically addressed the issue of AH during frozen-thawed embryo transfers ( FET ) cycles , those that have reported controversial results . The aim of this study was to evaluate the benefit of an enzymatic zona pellucida treatment of frozen-thawed embryos before transfer . METHODS This was a prospect i
Output:
| This up date has demonstrated that whilst assisted hatching ( AH ) does appear to offer a significantly increased chance of achieving a clinical pregnancy , the extent to which it may do so only just reaches statistical significance .
The ' take home ' baby rate was still not proven to be increased by AH .
The included trials provided insufficient data to investigate the impact of AH on several important outcomes .
Most trials still failed to report on live birth rates |
MS213131 | ***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 objectives of this prospect i ve cohort study , conducted in New Haven , Connecticut , from 1998 to 2004 , were to describe disability states experienced by older persons , to evaluate the rate of transitions between states and the duration of disability episodes , and to determine whether these findings differ on the basis of physical frailty -- a condition of low physical capacity and vulnerability to adverse functional outcomes . Participants included 754 persons aged 70 years or older who were initially independent in four key activities of daily living : bathing , dressing , walking , or transferring . Disability was assessed during monthly telephone interviews for a median of 60 months , and participants were classified each month according to the following four states : no disability , mild disability ( one or two activities ) , severe disability ( three or four activities ) , and death . Transitions between states of disability and independence were common , with a majority of both frail and nonfrail participants experiencing at least one transition . The rate of transitions varied greatly among individuals . Nonfrail participants had lower rates of transition from less to more disability , higher rates of transition from more to less disability , and slightly shorter duration s of disability . To fully underst and the disabling process , investigators and clinicians must consider the episodic and recurrent nature of disability OBJECTIVE To test the feasibility of two models of home meal delivery with Meals-on-Wheels ( MOW ) applicants who were identified as being malnourished or " at-risk " as determined by the vali date d Mini Nutritional Assessment ( MNA ) . DESIGN A 6-month , prospect i ve comparative study of two nutrition intervention models with data collection at baseline , 3 months , and 6 months . R and omized treatment assignment was followed , with a few exceptions linked to particular client circumstances . SUBJECTS A total of 203 older adults ( age range = 60 to 90 years ) newly applying for homebound meal service were enrolled . At baseline , the body mass index ( BMI ) was 26.3+/-7.2 ( mean+/-SD ) in the " Traditional " MOW model ( 101 subjects including 30 malnourished ) , and the BMI was 27.6+/-9.0 in the " New " MOW model ( 102 subjects including 26 malnourished ) ( P = ns ) . INTERVENTION Study participants received either the Traditional MOW program of five hot meals per week , meeting 33 % of the Daily Reference Intake ( DRI ) or the restorative , comprehensive New MOW program of three meals and two snacks per day , 7 days a week , meeting 100 % of the DRI . Assessment s were conducted in the home of the participants . Main outcome measures The MNA was used to evaluate nutritional risk and status of participants at baseline , 3 months , and 6 months . St and ardized functional impairment scales , Activities of Daily Living ( ADL ) , and Instrumental Activities of Daily Living ( IADL ) evaluated limitations in activities of daily living and life management skills . Statistical analysis Comparisons between treatment groups were calculated with t tests or Wilcoxon rank-sum tests when appropriate . Comparisons among time periods between treatment groups were conducted with repeated measures analysis of variance . A general linear model was used to evaluate the relationship between change in functional status and BMI , controlling for sex . RESULTS The New MOW group gained significantly more weight between baseline and 3 months than did the Traditional MOW group ( 2.78 lb vs -1.46 lb , respectively , P = .0120 ) and again between baseline and 6 months ( 4.30 lb vs -1.72 lb , respectively , P = .0004 ) . MNA improved faster in the New MOW group . Functional change appeared to be related more to BMI and age than to treatment intervention . The malnourished participants in both groups took longer to affect positive change in nutrition measurements , with the New MOW group showing the most improvement over the 6-month measurement period . Both delivery models were well accepted . CONCLUSIONS Applicants for home meal delivery have varying nutrition needs . By addressing nutritional risk , interventions can be targeted to meet these needs . A new , restorative , comprehensive meal program improved nutritional status and decreased nutritional risk and can possibly impact independence and functionality BACKGROUND The Short Physical Performance Battery ( SPPB ) , which includes walking , balance , and chair st and s tests , independently predicts mobility disability and activities of daily living disability . To date , however , there is no definitive evidence from r and omized controlled trials that SPPB scores can be improved . Our objective was to assess the effect of a comprehensive physical activity ( PA ) intervention on the SPPB and other physical performance measures . METHODS A total of 424 sedentary persons at risk for disability ( ages 70 - 89 years ) were r and omized to a moderate-intensity PA intervention or a successful aging ( SA ) health education intervention and were followed for an average of 1.2 years . RESULTS The mean baseline SPPB score on a scale of 0 - 12 , with 12 corresponding to highest performance , was 7.5 . At 6 and 12 months , the PA versus SA group adjusted SPPB ( + /- st and ard error ) scores were 8.7 + /- 0.1 versus 8.0 + /- 0.1 , and 8.5 + /- 0.1 versus 7.9 + /- 0.2 , respectively ( p < .001 ) . The 400-meter walking speed was also significantly improved in the PA group . The PA group had a lower incidence of major mobility disability defined as incapacity to complete a 400-meter walk ( hazard ratio = 0.71 , 95 % confidence interval = 0.44 - 1.20 ) . CONCLUSIONS A structured PA intervention improved the SPPB score and other measures of physical performance . An intervention that improves the SPPB performance may also offer benefit on more distal health outcomes , such as mobility disability OBJECTIVE To determine whether a home-based physical therapy ( PT ) program prevented decline in several higher-level measures of physical function among physically frail , community-living older persons . DESIGN R and omized controlled trial . SETTING General community . PARTICIPANTS Persons ( N=188 ) who were physically frail and aged 75 years or older . INTERVENTION A home-based PT program ( ie , prehabilitation ) that focused primarily on improving underlying impairments in physical capabilities . MAIN OUTCOME MEASURES Self-reported instrumental activities of daily living ( IADLs ) ; mobility , as determined by a modified version of the Performance Oriented Mobility Assessment ; timed rapid gait and timed chair st and s ; and integrated physical performance , as determined by a modified version of the Physical Performance Test , were assessed at baseline , 7 months , and 12 months . RESULTS As compared with participants in the educational control group , participants in the intervention group had reductions in IADL disability of 17.7 % at 7 months ( P=.036 ) and 12.0 % at 12 months ( P=.143 ) and had gains , ranging from 7.2 % to 15.6 % , in mobility and integrated physical performance at 7 and 12 months . CONCLUSIONS Our home-based prehabilitation program offered modest but consistent benefits for the prevention of decline in several higher-level measures of physical function OBJECTIVE To evaluate the impact of nutritional supplementation on nutritional status , muscle strength , perceived health , and functional status in a population of community-living , frail , undernourished elderly people . DESIGN A 16-week intervention study in which subjects were r and omized to an experimental or a control group and visited in their home on a monthly basis . Outcome variables were measured at the start and end of the study at subjects ' homes by a dietitian blinded to treatment assignment . SUBJECTS/ SETTING 83 elderly people ( experimental group : n=42 ; control group : n=41 ; mean age=80+/-7 years ) receiving community home-care services and at high risk for undernutrition . INTERVENTION Provision of a nutrient-dense protein-energy liquid supplement and encouragement to improve intake from other foods . OUTCOME MEASURES Anthropometric indexes , h and grip strength , isometric elbow flexion and leg extension strength , lower extremity function , perceived health , and functional status . STATISTICAL ANALYSES Study groups were compared on an " intention to treat " basis using analysis of variance for repeated measures and unpaired and paired t tests and their nonparametric equivalents where appropriate . RESULTS Total energy intake ( 1,772 vs 1,440 kcal ; P<.001 ) and weight gain ( 1.62 vs 0.04 kg ; P<.001 ) were higher in the supplemented group . No significant changes were observed with respect to other anthropometric indexes , muscle strength , or functional variables ; however , beneficial effects were observed in emotional role functioning ( P<0.01 ) and number of days spent in bed ( P=.04 ) . APPLICATIONS/ CONCLUSIONS Nutrition intervention is feasible in free-living , frail , undernourished elderly people and results in significant improvement of nutritional status with respect to energy and nutrient intake and weight gain . Weight loss can be stopped and in some cases reversed ; however , increased physical activity may also be required to improve health and functional status OBJECTIVES Although deficits in skeletal muscle strength , gait , balance , and oxygen uptake are potentially reversible causes of frailty , the efficacy of exercise in reversing frailty in community-dwelling older adults has not been proven . The aim of this study was to determine the effects of intensive exercise training ( ET ) on measures of physical frailty in older community-dwelling men and women . DESIGN R and omized controlled trial . SETTING Medical school research center . PARTICIPANTS One hundred fifteen sedentary men and women ( mean age + /- st and ard deviation = 83 + /- 4 ) with mild to moderate physical frailty , as defined by two of the following three criteria : Modified Physical Performance Test ( modified PPT ) score between 18 and 32 , peak oxygen uptake ( VO2 peak ) between 10 and 18 mL/kg/min , and self-report of difficulty or assistance with one basic activity of daily living ( ADL ) , or two instrumental ADLs . INTERVENTION Participants were r and omly assigned to a control group that performed a 9-month low-intensity home exercise program ( control ) or an exercise-training program ( ET ) . The control intervention primarily consisted of flexibility exercises . ET began with 3 months of flexibility , light-resistance , and balance training . During the next 3 months , resistance training was added , and , during the next 3 months , endurance training was added . MEASUREMENTS Modified PPT score , VO2 peak , performance of ADLs as measured by the Older Americans Re sources and Services instrument , and the Functional Status Question naire ( FSQ ) . RESULTS ET result ed in significantly greater improvements than home exercise in three of the four primary outcome measures . Adjusted 95 % confidence bounds on the magnitude of improvement in the ET group compared with the control group were 1.0 to 5.2 points for the modified PPT score , 0.9 to 3.6 mL/kg/min for VO2 peak , and 1.6 to 4.9 points for the FSQ score . CONCLUSIONS Our results show that intensive ET can improve measures of physical function and pre clinical disability in older adults who have impairments in physical performance and oxygen uptake and are not taking hormone replacement therapy better than a low-intensity home exercise program OBJECTIVE To determine the effects of center-based exercise on physical performance in older persons at risk for decline in physical functioning . DESIGN R and omized controlled trial . SETTING Senior centers . PARTICIPANTS A total of 155 community-dwelling persons , 78.7 % women , ages 70 years and older ( mean + /- st and ard deviation , 77.0+/-4.5y ) , with mobility impairments . INTERVENTION Intervention volunteers ( n=80 ) exercised at a center ( endurance , strength , balance , flexibility ) 3 times weekly , for months 1 to 6 ; once weekly , for months 7 to 12 with home exercise 2 sessions a week ; and at home only , for months 13 to 18 . Home control volunteers ( n=75 ) were instructed in home endurance exercise . MAIN OUTCOME MEASURES MacArthur battery , Physical Performance Test ( PPT-8 ) , and 6-Minute Walk Test ( 6MWT ) at baseline and 3 , 6 , 12 , and 18 months . RESULTS MacArthur battery scores improved in intervention compared with home control at 3 , 6 , and 12 months ( repeated- measures analysis of variance : group x time , P<.05 ) but not 18 months . PPT-8 and 6MWT did not improve . Intervention group assignment , younger age , and better baseline physical function and self-perceived health were independent predictors of long-term MacArthur battery score improvement . CONCLUSIONS Compared with home control , center-based exercise improved gait , chair rise time , and balance over 1 year . Improvements were not sustained with transition to home exercise for months 13 to 18 . Classes may be necessary to maintain improvements in older persons attending center-based exercise PURPOSE To determine how often disability in essential activities of daily living develops insidiously , and to evaluate whether the likelihood of insidious disability differs on the basis of physical frailty . METHODS We conducted a prospect i ve study of 754 nondisabled , community-living persons aged 70 years or older . Participants were categorized according to the presence or absence of physical frailty , which was defined on the basis of gait speed . Participants were subsequently followed with monthly telephone interviews for 3 years to determine the occurrence of disability in bathing , dressing , walking , or transferring , and to ascertain exposure to precipitating
Output:
| Results No evidence was found for the effect of nutritional interventions on disability measures .
There was no evidence for the effect of single lower extremity strength training on disability .
Differences between the multi-component interventions in e.g. individualization , duration , intensity and setting hamper the interpretation of the elements that consistently produced successful outcomes .
Conclusion There is an indication that relatively long-lasting and high-intensive multicomponent exercise programs have a positive effect on ADL and IADL disability for community-living moderate physically frail older persons . |
MS213132 | ***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: Relationships among risky sexual behaviors , other problem behaviors , and the family and peer context were examined for two sample s of adolescents . Many adolescents reported behaviors ( e.g. , promiscuity or nonuse of condoms ) which risked HIV or other sexually transmitted disease infection . Such risky behaviors were significantly intercorrelated . Consistent condom use was rare among those whose behavior otherwise entailed the greatest risk of infection . In both sample s , an index of high-risk sexual behavior was significantly related to antisocial behavior , cigarette smoking , and illicit drug or alcohol use . Social context variables , including family structure , parenting practice s , and friends ' engagement in problem behaviors , were associated with high-risk sexual behavior . Finally , for sexually active adolescents , problem behaviors and social context variables were predictive of nonuse of condoms . Results were consistent across the two studies and regression weights held up well under cross-validation This study tested the effectiveness of a prevention curriculum , All Stars , as implemented in a year-long school-based after school program and provides an independent replication of the effects of All Stars on targeted mediators and problem behaviors using an experimental methodology . Middle school students ( N = 447 ) who registered for the after school program were r and omly assigned to the experimental or control condition . The sample included approximately equal proportions of males and females , was 70 % African American , and 59 % of the students received subsidized meals at school . All Stars was delivered with reasonable integrity to the program design , although with lower quality than reported in earlier efficacy trials . However , actual student exposure to the program was lower than expected due to low levels of attendance in the after school program . Students who ever attended received an average of 16 h of All Stars instruction . Results showed no differences between the treatment and control students at post-test on any of the outcomes or mediators . Further , no positive effects were found for youths receiving higher dosage , higher quality program delivery , or both . Insufficient time to achieve high quality implementation in the after school context and potential deviancy training are suggested as reasons for the failure to replicate positive program effects 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 We developed a 9-week after-school , small group , activities-based intervention focused on enhancing youth 's abilities to imagine themselves as successful adults and connecting these future imagines to current school involvement . We describe and evaluate this programme comparing three cohorts of urban African American middle school students ( n=62 experimental , n=146 control ) , controlling for sex and previous school involvement . By the end of the school year , intervention youth reported more bonding to school , concern about doing well in school , " balanced " possible selves , plausible strategies to attain these possible selves , better school attendance , and for boys , less trouble at school Experiences that are deeply engaging and enjoyable , engender full concentration , and present a balance between challenge and skill promote children 's development . This chapter describes a study that sought to identify the kinds of setting s and activities that foster engagement and , by extension , positive youth development . The after-school experiences of 191 ethnically diverse youth living in three states , some of whom participated in after-school programs and some of whom did not , were studied . Youth were equipped with logbooks and watches that were programmed to signal at r and om times . When signaled , youth recorded their location , social partners , activity , and feelings . The study found pervasive differences in the experiences at programs and elsewhere . Youth spent more time in academic and arts enrichment , organized sports and physical activities , community service , and homework at programs versus elsewhere , and they spent less time eating and watching TV at programs . They also reported higher levels of motivation , engagement , and positive affect at programs . At the same time , there were few differences in activities , emotions , effort , or motivation of program participants and non participants when both groups were elsewhere . The similarities in these experiences while elsewhere suggest that the program context , not differences in youth characteristics or interests , was responsible for the feelings of engagement that were reported at programs After school programs ( ASPs ) are popular and receive substantial public funding . Aside from their child-care and supervision value , ASPs often provide youth development and skill-building activities that might reduce delinquent behavior . These possibilities and the observation that arrests for juvenile crime peak between 2 p.m. and 6 p.m. on school days have increased interest in the delinquency prevention potential of ASPs . This study examined effects of participation in ASPs conducted in Maryl and during the 1999 - 2000 school year and the mechanism through which such programs may affect delinquent behavior . Results imply that participation reduced delinquent behavior for middle-school but not for elementary-school-aged youths . This reduction was not achieved by decreasing time spent unsupervised or by increasing involvement in constructive activities , but by increasing intentions not to use drugs and positive peer associations . Effects on these outcomes were strongest in programs that incorporated a high emphasis on social skills and character development Objective : This pilot study tests the feasibility and preliminary efficacy of an after-school treatment program for middle schoolers with ADHD using a r and omized clinical trial design . Method : A total of 23 students with ADHD ( 25 % female , 48 % African American ) from a large public middle school were r and omly assigned to a 10-week program or to community comparison . Manualized treatment targeted educational , social , and recreational skills , homework completion , and school and home behavior . Parents participated . Results : Recruitment and r and omization targets were easily met ( 87 % completion ) . Parent and teacher satisfaction was positive . Small to medium treatment effects result ed despite greater medication use in the control group , with improvements in functioning for the program-treated youth or absence of deterioration relative to the comparison group . Conclusion : Despite testing an abbreviated version of the after-school program ( < 5 months ) , this study reveals feasibility and palatability for this intervention and modest beneficial effects on behavioral and academic outcomes . ( J. of Att . Dis . 2008 ; 12(3 ) 207 - 217 BACKGROUND AND OBJECTIVE To conduct a pilot study to compare the frequency of errors that accompany single vs. double data extraction , compare the estimate of treatment effect derived from these methods , and compare the time requirements for these methods . METHODS Review ers were r and omized to the role of data extractor or data verifier , and were blind to the study hypothesis . The frequency of errors associated with each method of data extraction was compared using the McNemar test . The data set for each method was used to calculate an efficacy estimate by each method , using st and ard meta-analytic techniques . The time requirement for each method was compared using a paired t-test . RESULTS Single data extraction result ed in more errors than double data extraction ( relative difference : 21.7 % , P = .019 ) . There was no substantial difference between methods in effect estimates for most outcomes . The average time spent for single data extraction was less than the average time for double data extraction ( relative difference : 36.1 % , P = .003 ) . CONCLUSION In the case that single data extraction is used in systematic review s , review ers and readers need to be mindful of the possibility for more errors and the potential impact these errors may have on effect estimates
Output:
| Mean effects were small and non-significant for attendance and externalizing behaviors .
A moderate to large amount of heterogeneity was present ; however , no moderator variable tested explained the variance between studies . |
MS213133 | ***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: OBJECTIVE The aims of the study were to assess factors responsible for the reduction of preoperative anxiety in patients undergoing breast and abdominal surgeries . In particular , we investigated whether question prompt lists ( QPL ) , patients ' knowledge , or the communication skills of surgeons had effects on anxiety reduction . METHODS Patients were r and omly assigned to QPL and control groups . Anxiety was assessed on the State Trait Anxiety Inventory . RESULTS Both groups showed significant reduction in anxiety between initial consultation and one day prior to surgery , with QPL patients showing a trend towards a greater reduction of anxiety after surgery and a significant reduction at the first outpatient follow-up . Satisfaction with consultation and the doctor 's ability to answer questions concerning diagnosis , and treatment were significantly associated with anxiety reduction . CONCLUSION Effective anxiety reduction hinged on doctors ' communication abilities and patients ' satisfaction with the consultation Active participation in the medical consultation has been demonstrated to benefit aspects of patients ’ subsequent psychological well-being . We investigated two interventions promoting patient question -asking behaviour . The first was a question prompt sheet provided before the consultation , which was endorsed and worked through by the clinician . The second was a face to face coaching session exploring the benefits of , and barriers to , question -asking , followed by coaching in question -asking behaviour employing rehearsal techniques . Sixty patients with heterogeneous cancers , seeing two medical oncologists for the first time , were r and omly assigned to one of three groups : two intervention groups and one control group . Sociodemographic variables and anxiety were assessed prior to the intervention which preceded the consultation . The consultations were audiotaped and subsequently analysed for question -asking behaviour . Anxiety was assessed again immediately following the consultation . Question naires to assess patient satisfaction , anxiety and psychological adjustment were sent by mail 2 weeks following the consultation . Presentation and discussion of the prompt sheet significantly increased the total number of questions asked and the number of questions asked regarding tests and treatment . Coaching did not add significantly to the effects of the prompt sheet . Psychological outcomes were not different among the groups . We conclude that a question prompt sheet addressed by the doctor is a simple , inexpensive and effective means of promoting patient question asking in the cancer consultation Patient participation in medical consultations has been demonstrated to benefit their subsequent psychological well being . Question asking is one way in which patients can be active . We investigated 2 means of promoting cancer patient question asking . One was the provision of a question prompt sheet to patients prior to their initial consultation with their oncologist . The second was the active endorsement and systematic review of the question prompt sheet by their oncologist . 318 patients with heterogeneous cancers , seeing one of 5 medical and 4 radiation oncologists for the first time , were r and omised to either receive or not receive a question prompt sheet . Doctors were r and omised to either proactively address or passively respond to the question prompt sheet in the subsequent consultation . Anxiety was assessed prior to the consultation . Consultations were audiotaped and content analysed . Anxiety was assessed again immediately following the consultation . Within the next 10 days patients completed question naires assessing information needs , anxiety and satisfaction and were given a structured telephone interview assessing information recall . Patients provided with a question prompt sheet asked more questions about prognosis compared with controls and oncologists gave significantly more prognostic information to these patients . Provision of the question prompt sheet prolonged consultations and increased patient anxiety ; however , when oncologists specifically addressed the prompt sheet , anxiety levels were significantly reduced , consultation duration was decreased and recall was significantly improved . A patient question prompt sheet , used proactively by the doctor , is a powerful addition to the oncology consultation . © 2001 Cancer Research Campaign Background . This investigation examined factors affecting patient involvement in consultations to decide local treatment for early breast cancer and the effectiveness of two methods of preconsultation education aim ed at increasing patient participation in these discussion This study was conducted to evaluate the feasibility of using a computer intervention to enhance communication between healthcare professionals and women with breast cancer . Additional aims were to measure the extent to which women achieved their preferred decisional roles and satisfaction with the clinical medical appointment . This two-arm r and omized clinical trial design included a convenience sample of 749 women with breast cancer attending 3 urban Canadian outpatient oncology clinics . Most women were older than 50 years and had a high school diploma or greater ( 57 % ) . Women in the control group completed measures of decision preference before their clinic appointments . Women in the intervention group were encouraged to use the information and decision preference profiles generated by the computer program at their clinic appointments . Levels of involvement in decision making and satisfaction were measured after the clinic appointments . Results showed that although the majority of women in both groups did assume their preferred roles in decision making , a significantly higher proportion of women in the intervention group reported playing a more passive role than originally planned . Both groups reported high satisfaction levels . Future research is required to study how this computer intervention could be used by clinicians to provide information and decision support to these women The purpose of this study was to determine the helpfulness of a prompt sheet versus a general information sheet for patient communication with physicians . Sixty women with breast cancer attending their first outpatient consultation with a breast medical oncologist were r and omized to receive either a prompt sheet ( PS ) or a general information ( GI ) sheet regarding breast cancer . Analysis of the results found that helpfulness of the written material was rated higher in the PS group ( 8.5 + /- 2 ) than the GI group ( 6.2 + /- 3.6 ) , P = 0.005 . The mean score of helpfulness in communicating with physicians was 7.9 + /- 2.4 and 5.7 + /- 3.8 , respectively , P = 0.01 . There were no significant differences between the groups in the average total number of questions asked by the patients or average physician or patient speaking time . We conclude that a disease-specific prompt sheet provided before medical encounters may assist in communication between patients and physicians OBJECTIVE The objective of this study was to evaluate the patients ' perception of the usefulness of a question prompt sheet ( QPS ) in facilitating the involvement of advanced cancer patients during consultation . METHODS Advanced cancer patients attending their first consultation after diagnosis were r and omly assigned to the intervention group ( received QPS and a hospital introduction sheet ( HIS ) ) or the control group ( received HIS only ) . Analysis was conducted on an intention-to-treat basis . The primary outcome measure was patient rating of the usefulness of the material ( s ) ( numerical rating scale of 0 - 10 ) . RESULTS Sixty-three advanced cancer patients ( 72.4 % response rate ) were enrolled and analyzed . Nearly three-quarters of patients in both groups read the material ( s ) before consultation . The rated usefulness of the material ( s ) for asking questions of physicians was significantly higher in the intervention group than in controls ( 4.4 ± 3.6 and 2.7 ± 2.8 , respectively ; p = 0.033 ) . The mean score of the usefulness of the material ( s ) for underst and ing the treatment plan tended to be higher in the intervention group than in the controls ( 4.9 ± 3.6 and 3.3 ± 2.8 ; p = 0.051 ) . The mean score of willingness to use the material ( s ) in the future was significantly higher in the intervention group than in the controls ( 5.3 ± 3.8 and 2.8 ± 2.8 ; p = 0.006 ) . There were no significant differences between the groups in the average total number of questions asked by patients ( median , 1.0 ; interquartile range in both groups , 2.0 ) . CONCLUSIONS QPS provided before oncology consultation may be useful for advanced cancer patients , on the other h and , it did not directly promote patient confidence to ask questions A r and omized pre- and post-test control group design was conducted in 12 oncology wards to investigate the effectiveness of an intervention , existing of a communication skills training with web-enabled video feedback and a Question Prompt Sheet ( QPS ) , which aim ed to improve patient education to older cancer patients ( ≥65 years ) . The effects were studied by analyzing question naires and video recordings of patient education sessions preceding chemotherapy with 210 different patients . Patients ' recall of information was the primary outcome of the study . Recall was checked against the actual communication in the video-recordings . Moreover , communication skills were assessed by observing the extent to which nurses implemented 67 communication aspects , categorized in seven dimensions , using the QUOTE(chemo ) . Experimental nurses demonstrated a significant intervention effect on communicating realistic expectations . Within-group improvements were measured in the experimental group for tailored communication , affective communication and interpersonal communication . Although the use of a QPS significantly increased question asking , only limited results were found on older patients ' recall scores . The overall proportion recall of recommendations showed a marginally significant pre-/post-change in proportion recall in favour of the experimental group and there was a significant pre-/post-change in two out of six sub-categories . The results indicate that nurses ' communication skills can be improved by communication skills training . More research is needed to underst and the difficult relationship between patient-provider communication and recall of information PURPOSE To determine whether provision of a question prompt list ( QPL ) influences advanced cancer patients ' /caregivers ' questions and discussion of topics relevant to end-of-life care during consultations with a palliative care ( PC ) physician . PATIENTS AND METHODS This r and omized controlled trial included patients r and omly assigned to st and ard consultation or provision of QPL before consultation , with endorsement of the QPL by the physician during the consultation . Consecutive eligible patients with advanced cancer referred to 15 PC physicians from nine Australian PC services were invited to participate . Consultations were audiotaped , transcribed , and analyzed by blinded coders ; patients completed question naires before , within 24 hours , and 3 weeks after the consultation . RESULTS A total of 174 patients participated ( 92 QPL , 82 control ) . Compared with controls , QPL patients and caregivers asked twice as many questions ( for patients , ratio , 2.3 ; 95 % CI , 1.7 to 3.2 ; P < .0001 ) , and patients discussed 23 % more issues covered by the QPL ( 95 % CI , 11 % to 37 % ; P < .0001 ) . QPL patients asked more prognostic questions ( ratio , 2.3 ; 95 % CI , 1.3 to 4.0 ; P = .004 ) and discussed more prognostic ( ratio , 1.43 ; 95 % CI , 1.1 to 1.8 , P = .003 ) and end-of-life issues ( 30 % v 10 % ; P = .001 ) . Fewer QPL patients had unmet information needs about the future ( 21 = 4.14 ; P = .04 ) , which was the area of greatest unmet information need . QPL consultations ( average , 38 minutes ) were longer ( P = .002 ) than controls ( average , 31 minutes ) . No differences between groups were observed in anxiety or patient/physician satisfaction . CONCLUSION Providing a QPL and physician endorsement of its use assists terminally ill cancer patients and their caregivers to ask questions and promotes discussion about prognosis and end-of-life issues , without creating patient anxiety or impairing satisfaction This study aims to develop and pilot a question prompt sheet to assist esophageal cancer patients to obtain desired information in the consultation in which potentially curative esophagectomy is discussed . Whether a prompt sheet affected patients ' question asking , the number and scope of topics discussed , the length of the consultation , and patients ' satisfaction is investigated . Patients ( n= 30 ) were r and omized either to receive care as usual ( control group ) or to receive a prompt sheet ( intervention group ) . All patients completed a baseline question naire , their consultations were audio-recorded and content-coded , and they received a structured telephone interview 2 days after the consultation to assess satisfaction . Patients provided with the prompt sheet marked a median of 19 questions . They asked significantly more questions as compared with patients in the control group ( median of 12 vs. 8 questions ) . Questions mainly addressed treatment options and procedures . No differences were found with regard to consultation length and patient satisfaction . Our results suggest that providing patients with a simple , easy-to-implement tool such as a question prompt is appreciated and helps patients to ask more questions during the consultation without increasing the length of the consultation OBJECTIVE Does decision navigation ( DN ) increase prostate cancer patients ' confidence and certainty in treatment decisions , while reducing regret associated with the decisions made ? METHODS Two hundred eighty-nine newly diagnosed prostate cancer patients were eligible . 123 consented and were r and omised to usual care ( n = 60 ) or navigation ( n = 63 ) . The intervention involved a ' navigator ' guiding the patient in creating a personal question list for a consultation and providing a CD and typed summary of the consultation to patients , the general practitioner and physician . The primary outcome was decisional self efficacy . Secondary outcomes included decisional conflict ( DCS ) and decisional regret ( RS ) . Measures of mood ( Hospital Anxiety and Depression Scale ) and adjustment ( Mental Adjustment to Cancer Scale ) were included to detect potential adverse effects of the intervention . RESULTS ANOVA showed a main effect for the group ( F = 7.161 , df 1 , p = 0.009 ) . Post hoc comparisons showed significantly higher decisional self efficacy in the navigated patients post-consultation and 6 months later . Decisional conflict was lower for navigated patients initially ( t = 2.005 , df = 105 , p = 0.047 ) , not at follow-up ( t = 1.969 , df = 109 , p = 0.052 ) . Regret scores were significantly lower in the navigation group compared to the controls 6 months later ( t = -2.130 , df = 100 , p = 0.036 ) . There was no impact of the intervention on mood or adjustment . CONCLUSION Compared to control patients , navigated patients were more confident in making decisions about cancer treatment , were more certain they had made the right decision after the consult
Output:
| The majority of QPL interventions were given to patients before their consultation in hardcopy .
It is suggested that characteristics of a QPL intervention ( i.e. , the number of questions on a QPL and provider training ) can influence its effectiveness .
Question Prompt List interventions are effective in improving communication , psychological and cognitive outcomes of cancer patients |
MS213134 | ***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 —17&bgr;-Estradiol ( E2 ) offers cardiovascular protection in young female animals and postmenopausal women . In contrast , r and omized trials of menopausal hormones performed in older women have shown harm or no cardiovascular benefit . We hypothesize that E2 effects on vascular inflammation are age dependent . Approach and Results —Young ( 10 weeks ) and aged ( 52 weeks ) female C57BL/6 mice were used as source for primary cultures of bone marrow – derived macrophages ( BMMs ) and vascular smooth muscle cells ( VSMCs ) . E2 pretreatment of cells derived from young mice attenuated C-reactive protein (CRP)–induced expression of inflammatory mediators . In contrast , E2 pretreatment of cells from aged mice did not alter ( BMMs ) or paradoxically exaggerated ( VSMCs ) inflammatory mediator response to CRP . Using E2 receptor ( ER ) knockout mice , we demonstrated that E2 regulates inflammatory response to CRP in BMMs via ER&agr ; and in VSMCs via ER&bgr;. BMMs derived from aged ( versus young ) mice expressed significantly less ER&agr ; mRNA and protein . A selective lig and of the novel ER GPR30 reproduced the E2 effects in BMMs and VSMCs . Unlike in young mice , E2 did not reduce neointima formation in ligated carotid arteries of aged CRP transgenic mice . Conclusions —E2 attenuates inflammatory response to CRP in BMMs and VSMCs derived from young but not aged mice and reduces neointima formation in injured carotid arteries of young but not aged CRP transgenic mice . ER&agr ; expression in BMMs is greatly diminished with aging . These data suggest that vasoprotective effects of E2 are age dependent and may explain the vasotoxic effects of E2 seen in clinical trials of postmenopausal women We have demonstrated that long-term 17β-estradiol attenuated fibrosis after myocardial infa rct ion , but recent evidence suggests that estrogen mediates more rapid cellular effects . RhoA has been shown to play a role in the control of myocardial fibrosis by regulating the actin-regulatory protein cofilin . We sought to eluci date whether RhoA activity regulates estradiol-induced fibrosis after infa rct ion in ovariectomized female rats . Twenty-four hours after coronary ligation , female Wistar rats were r and omized into control or estradiol treatment for 4 weeks starting from 2 weeks after bilateral ovariectomy . There were similar infa rct sizes among the infa rct ed groups . Myocardial fibrosis was significantly reduced , as measured by hydroxyproline content , Sirius Red staining and actin polymerization after administering estradiol . Estradiol treatment was associated with RhoA/Rho kinase inhibition evidence d by increased phosphorylation of RhoA and decreased phosphorylation of downstream factors including cofilin . Administration of PPT , a specific ERα agonist , or a membrane impermeable estrogen – albumin construct also inhibited cofilin phosphorylation , suggesting that cofilin phosphorylation is achieved through the recruitment of a membrane ERα . The ERβ-selective agonist , DPN , did not alter cofilin phosphorylation levels , but the ER antagonist , ICI 182,780 increased cofilin phosphorylation levels . G-15 ( an inhibitor of G-protein coupled estrogen receptor ) did not affect the phosphorylation as compared with estradiol alone . The inhibitor of Rho kinase , Y-27632 , attenuated cofilin phosphorylation levels , similar to the effect produced by estradiol . These results indicate that chronic use of estradiol after infa rct ion attenuates cardiac fibrosis by inhibiting RhoA/ROCK/cofilin pathway , which is exerted through membrane ERα-mediated receptor mechanism . Key MessagePostinfa rct ion was associated with increased cardiac fibrosis . Myocardial fibrosis was significantly reduced after administering estradiol (E2).Administration of the membrane ERα agonist PPT or E2-BSA inhibited cofilin phosphorylation . Combination of E2 and Y-27632 did not enhance the attenuation of cofilin phosphorylation . Chronic use of E2 attenuated cardiac fibrosis by inhibiting the RhoA/ROCK/cofilin pathway via ERα BACKGROUND Environmental and genetic factors contribute to the development of complex diseases such as myocardial infa rct ion ( MI ) , the leading cause of death in men and women . Women develop MI approximately 10 years later than men , a difference that could be explained by the genes coding for the estrogen receptors . Single nucleotide polymorphisms ( SNPs ) in the ESR2 gene may affect susceptibility for MI in a sex-dependent manner . METHODS A nested case-control design was used to analyze 3 polymorphisms of the ESR2 gene and their associated haplotypes in 710 myocardial infa rct ion cases from the REGICOR ( Registre Gironí del Corazón ) study and 2379 controls r and omly selected in a representative population of a Spanish cross-sectional study . RESULTS The rs1271572 T allele was significantly more common in patients who developed MI ( P < 0.001 ) . No association was observed for rs1256049 or rs4986938 . Assuming a dominant model of inheritance , the association , as determined by logistic multivariate regression after adjustment for conventional cardiac risk factors , remained statistically significant in men [ odds ratio ( OR ) 1.65 , 95 % CI 1.18 - 2.30 ; P = 0.003 ) but not in women ( P = 0.754 ) . A very common haplotype encompassing the rs1271572 variant was also associated with the risk of MI in the overall population ( OR 1.41 , 95 % CI 1.06 - 1.87 ; P = 0.020 ) and in men ( OR 1.57 , 95 % CI 1.12 - 2.21 ; P = 0.009 ) . CONCLUSIONS The rs1271572 SNP T variant was associated with increased risk of MI in a Spanish population , and this association was found to be limited to men only . Sex differences in the genetic risk merit further investigation OBJECTIVE Hormone therapy ( HT ) has been suggested to improve vascular function and inflammation in menopausal women , although not consistently . We aim ed to investigate the effects of HT on endothelial function and inflammation , especially sCD40L , in early menopausal women , and the effect of common estrogen receptor ( ER ) polymorphisms on vascular responses to HT . STUDY DESIGN Eighty-four early menopausal women ( <3 years in menopause ) with menopausal complaints eligible for HT . Forty women received transdermal 17β-estradiol plus cyclical micronized progesterone for 3 months while 44 did not ( controls ) . MAIN OUTCOME MEASURES Brachial artery flow-mediated dilation ( FMD ) and vascular inflammation markers ( sICAM , sP-Selectin and sCD40L ) . Genetic polymorphisms of ERα ( PvuII 454 - 397T > C and XbaI 454 - 351A > G ) and ERβ ( AluI 1730A > G ) were also assessed . RESULTS The two groups did not differ at baseline . Following HT , vasomotor complaints ' severity , blood pressure , LDL , sCD40L , sICAM and sP-Selectin decreased and FMD increased compared to controls ( P<0.05 for all ) . ERβ AluI A allele presence was the most important independent predictor of HT-induced increase in FMD while ERα XbaI A allele was the only independent predictor of decrease in sCD40L . CONCLUSIONS Short-term HT in early menopausal women improved endothelial function and inflammation . Specific ER polymorphisms that were found to be main determinants of HT-induced effects on endothelium could identify subgroups of women who may benefit the most from HT
Output:
| ERβ seems to possess multiple functions in the female cardiovascular system . |
MS213135 | ***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: Freeman et al. demonstrated that detection sensitivity for a low contrast Gabor stimulus improved in the presence of flanking , collinearly oriented grating stimuli , but only when observers attended to them . By recording visual event-related potentials ( ERPs ) elicited by a Gabor stimulus , we investigated whether this context ual cueing effect involves changes in the short-latency afferent visual signal from V1 that have a stimulus onset latency between 60 and 80 ms and /or longer-latency changes from visual cortex . Under dual-task conditions , the subjects performed contrast discrimination for a central Gabor and an orientation judgment for a pre-specified subset of the flanking Gabors . On r and om trials , the central Gabor could be collinearly or orthogonally oriented with respect to the attended flankers . Subjects showed improvements in discriminating the contrast of the central grating when it was oriented collinearly with the attended flankers . The ERP difference between attending to collinear versus orthogonal flankers manifested as a positive polarity response at occipital electrodes with a latency of 180 - 250 ms after stimulus onset . No shorter-latency context ual cueing differences were observed in the ERPs . The ERP latency profile of the context ual cueing effect argues against the hypothesis that short-latency afferent activity from V1 is the stage of processing at which attention can influence neuronal lateral interactions . However , the scalp voltage distribution of the longer-latency context ual cueing effect is similar to the one generated by the early phasic stimulus onset activity from V1 . These findings leave open the possibility that V1 is involved in the attentional modulation of lateral interactions but that this has a longer time course , likely being mediated by re-afferent inputs from later stages of the visual pathway In 3 studies , the authors investigated the functional role of psychological resilience and positive emotions in the stress process . Studies 1a and 1b explored naturally occurring daily stressors . Study 2 examined data from a sample of recently bereaved widows . Across studies , multilevel r and om coefficient modeling analyses revealed that the occurrence of daily positive emotions serves to moderate stress reactivity and mediate stress recovery . Findings also indicated that differences in psychological resilience accounted for meaningful variation in daily emotional responses to stress . Higher levels of trait resilience predicted a weaker association between positive and negative emotions , particularly on days characterized by heightened stress . Finally , findings indicated that over time , the experience of positive emotions functions to assist high-resilient individuals in their ability to recover effectively from daily stress . Implication s for research into protective factors that serve to inhibit the scope , severity , and diffusion of daily stressors in later adulthood are discussed Objective : According to the attention network approach , attention is best understood in terms of three functionally and neuroanatomically distinct networks — alerting , orienting , and executive attention . An important question is whether the experience of emotion differentially influences the efficiency of these networks . Method : This study examines 180 participants were r and omly assigned to a happy , sad , or control condition and undertook a modified version of the Attention Network Test . Results : The results showed no effect of happiness or sadness on alerting , orienting , or executive attention . However , sad participants showed reduced intrinsic alertness . Conclusion : This suggests that sadness reduces general alertness rather than impairing the efficiency of specific attention networks . ( J. of Att . Dis . 2010 ; 13(6 ) 629 - 639 The spatial distribution of visual attention was investigated by measuring target detectability ( d ' ) and event-related brain potentials ( ERPs ) to stimuli at varying distances from an attended locus . Vertical bars were flashed rapidly in r and om order to 1 of 3 locations : one in each of the lateral visual fields and one on the vertical meridian above the fixation point . Subjects maintained eye fixation while directing their attention to 1 of the 3 locations for the duration of each 1.75 min run . Their primary task was to detect infrequent , shorter target bars at the attended location . A secondary task was to respond to shorter target bars at either of the 2 unattended locations if they ' happened to notice them ' ( without trying to detect them ) . ERPs and d ' scores were obtained to the lateral field stimuli both when they were specifically attended ( primary task ) , as well as when attention was focused upon midline or opposite-field flashes ( secondary task ) . Both d ' scores and the amplitudes of the P135 and N190 waves decreased progressively as attention was directed to locations increasingly distant from a given lateral stimulus . These results support ' gradient ' models of the spatial distribution of visual attention Recent theory suggests that positive psychological processes integral to health may be energized through the self-reinforcing dynamics of an upward spiral to counter emotion dysregulation . The present study examined positive emotion – cognition interactions among individuals in partial remission from depression who had been r and omly assigned to treatment with mindfulness-based cognitive therapy ( MBCT ; n = 64 ) or a waitlist control condition ( n = 66 ) . We hypothesized that MBCT stimulates upward spirals by increasing positive affect and positive cognition . Experience sampling assessed changes in affect and cognition during 6 days before and after treatment , which were analyzed with a series of multilevel and autoregressive latent trajectory models . Findings suggest that MBCT was associated with significant increases in trait positive affect and momentary positive cognition , which were preserved through autoregressive and cross-lagged effects driven by global emotional tone . Findings suggest that daily positive affect and cognition are maintained by an upward spiral that might be promoted by mindfulness training 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 The broaden- and -build theory of positive emotions predicts that positive emotions broaden the scopes of attention and cognition , and , by consequence , initiate upward spirals toward increasing emotional well-being . The present study assessed this prediction by testing whether positive affect and broad-minded coping reciprocally and prospect ively predict one another . One hundred thirty-eight college students completed self-report measures of affect and coping at two assessment periods 5 weeks apart . As hypothesized , regression analyses showed that initial positive affect , but not negative affect , predicted improved broad-minded coping , and initial broad-minded coping predicted increased positive affect , but not reductions in negative affect . Further mediational analyses showed that positive affect and broad-minded coping serially enhanced one another . These findings provide prospect i ve evidence to support the prediction that positive emotions initiate upward spirals toward enhanced emotional well-being . Implication s for clinical practice and health promotion are discussed The influence of mood states on the propensity to use heuristics as expressed in stereotypes was examined using signal detection statistics . Participants experienced happy , neutral , or sad moods and " remembered " whether names connoting race ( African American , European American ) belonged to social categories ( criminal , politician , basketball player ) . Positive mood increased reliance on heuristics , indexed by higher false identification of members of stereotyped groups . Positive mood lowered sensitivity ( d ' ) , even among relative experts , and shifted bias ( beta ) or criterion to be more lenient for stereotypical names . In contrast , sad mood did not disrupt sensitivity and , in fact , revealed the use of a stricter criterion compared with baseline mood . Results support theories that characterize happy mood as a mental state that predisposes reliance on heuristics and sad mood as dampening such reliance Emotional states are known to influence how people process relevant information . Here , we address the impact of emotional state on irrelevant information . In this experiment , participants were r and omly assigned to a neutral or positive mood induction , and then completed a task that involved viewing a sequence of overlapping pictures and words . They were instructed to attend to the pictures and ignore the distracting words . Following a filled interval , implicit memory for the distracting words was tested using a word fragment completion task . Individuals in the positive mood group showed increased implicit memory for previously irrelevant information compared to those in the neutral mood group . These findings are consistent with the view that positive mood broadens attention to include encoding of irrelevant information in the environment , and this can impact subsequent performance Two studies tested the hypothesis that certain positive emotions speed recovery from the cardiovascular sequelae of negative emotions . In Study 1 , 60 subjects ( Ss ) viewed an initial fear-eliciting film , and were r and omly assigned to view a secondary film that elicited : ( a ) contentment ; ( b ) amusement ; ( c ) neutrality ; or ( d ) sadness . Compared to Ss who viewed the neutral and sad secondary films , those who viewed the positive films exhibited more rapid returns to pre-film levels of cardiovascular activation . In Study 2 , 72 Ss viewed a film known to elicit sadness . Fifty Ss spontaneously smiled at least once while viewing this film . Compared to Ss who did not smile , those who smiled exhibited more rapid returns to pre-film levels of cardiovascular activation . We discuss these findings in terms of emotion theory and possible health-promoting functions of positive emotions Research shows that positive mood can serve to broaden the scope of attention at both the perceptual and conceptual level ( e.g. , increasing the size of spatial attentional focus and semantic access to remote associates ) . We investigated whether this relaxation of attentional filters by positive affect reduces their selectivity for basic visual features . We induced positive , neutral , or negative affect and asked observers to identify a target motion direction in a series of rapid r and om moving dot displays . Using a reverse correlation method , we examined the differential effects of emotion on observers ' perceptual tuning curves for motion direction . Here we find that positive affect reduces selectivity for motion direction by broadening observers ' perceptual tuning relative to both neutral and negative affect conditions . These findings provide the first behavioral evidence that positive emotion influences selectivity for basic visual features through modulation of tuning properties We have used fMRI to examine the nature of the changes that occur in the human visual cortex when an observer attends to a particular location in the visual image . Previous studies have shown that the magnitude of the response to a visual stimulus is increased when the observer attends to the stimulus . We show that , in addition , attention to a particular location results in a widespread suppression of activity levels at all other locations . This suggests that a key mechanism of attentional modulation may be that spontaneous ( baseline ) levels of neural activity are adjusted in a position-dependent manner across the entire visual field Emotional experience in healthy men has been shown to rely on a brain network including subcortical as well as cortical areas in a complex interaction , which may be substantially influenced by many internal personal and external factors such as individuality , gender , stimulus material and task instructions . The divergent results may be interpreted by taking these considerations into account . Hence , many aspects remain to be clarified in characterizing the neural correlates underlying the subjective experience of emotion . One unresolved question refers to the influence of emotion quality on the cerebral substrates . Hence , 26 male healthy subjects were investigated with functional magnetic resonance imaging during st and ardized sad and happy mood induction as well as a cognitive control task to explore brain responses differentially involved in positive and negative emotional experience . Sad and happy mood in contrast to the control task produced similarly significant activations in the amygdala-hippocampal area extending into the parahippocampal gyrus as well as in the prefrontal and temporal cortex , the anterior cingulate , and the precuneus . Significant valence differences emerged when comparing both tasks directly . More activation has been demonstrated in the ventrolateral prefrontal cortex ( VLPFC ) , the anterior cingulate cortex ( ACC ) , the transverse temporal gyrus , and the superior temporal gyrus during sadness . Happiness , on the other h and , produced stronger activations in the dorsolateral prefrontal cortex ( DLPFC ) , the cingulate gyrus , the inferior temporal gyrus , and the cerebellum . Hence , negative and positive moods reveal distinct cortical activation foci within a common neural network , probably making the difference between qualitatively different emotional feelings Many previous studies have demonstrated that the visual N1 component is larger for attended-location stimuli than for unattended-location stimuli . This difference is observed typically only for tasks involving a discrimination of the attended-location stimuli , suggesting that the N1 wave reflects a discrimination process that is applied to the attended location . The present study tested this hypothesis by examining the N1 component elicited by attended stimuli under conditions that either required or did not require the subject to perform a discrimination . Specifically , the N1 elicited by foveal stimuli during choice-reaction time ( RT ) tasks was compared with the N1 elicited by identical stimuli during simple-RT tasks . In three experiments , a larger posterior N1 was observed in choice-RT tasks than in simple-RT tasks , even when several potential confounds were eliminated ( e.g. , arousal and motor preparation ) . This N1 discrimination effect was observed even when no motor response was required and was present for both color- and form-based discriminations . Moreover , this discrimination effect was equally large for easy and difficult discriminations , arguing against a simple re source -based explanation of the present results . Instead , the results of this study are consistent with the hypothesis that the visual N1 component reflects the operation of a discrimination process within the focus of attention Attending a certain region in space enhances activity in visual areas retinotopically mapped to this region ; stimuli presented in this region are preferentially processed . The zoom lens model of visual attention proposes that the attended region can be adjusted in size and predict
Output:
| While several studies reported a broadening of attention , others found that positive mood led to a more diffuse information processing style .
Positive mood appears to lessen attention selectivity in a way that is context -specific and bound to limitations .
This novel model is able to accommo date discrepant findings , seeks to translate the phenomenon of the so-called broadening of attention with positive mood into functional terms , and provides plausible neurobiological mechanisms underlying this effect , suggesting a crucial role of the anterior and posterior cingulate cortex in this interaction |
MS213136 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: One hundred and three patients with hemispheric supratentorial glioblastoma multiforme were studied . All patients were operated on and a histologic diagnosis of glioblastoma multiforme was made . Patients were r and omly placed in one of three treatment schedules within 3 weeks of surgery : Group A : combined radiation therapy and drug ( CCNU ) therapy ( 26 cases ) ; Group B : CCNU given orally every 6–8 weeks ( 27 cases ) ; Group C : st and ard radiation therapy alone ( 50 cases ) . All patients were periodically controlled by clinical and instrumental ( EEG , scan , EMG , CAT ) evaluations ; laboratory data examinations were also frequently performed . The treatment results have been evaluated according to length of survival , social quality of life , and positive or negative response to chemotherapy . In our opinion the clinical findings are interesting but the statistical results are somewhat negative , especially when the groups of patients are not homogeneous The Radiation Therapy Oncology Group ( RTOG ) and the Eastern Cooperative Oncology Group ( ECOG ) conducted a phase III trial in patients with malignant gliomas to evaluate 4 treatment arms : 1 ) 60 Gy to the whole brain ; 2 ) 60 Gy plus 10-Gy boost ; 3 ) 60 Gy plus carmustine ( BCNU ) ; and 4 ) 60 Gy plus semustine plus dacarbazine . Between September 1974 and March 1979 , 626 patients with malignant gliomas were treated on protocol RTOG 7401/ECOG 1374 . Each institution chose a subset of the treatments to which the patients would be r and omized . Patients were stratified according to subset and r and omized to the 4 treatment arms . There were no differences in survival among treatment arms . For patients greater than 60 years of age , the addition of chemotherapy to radiation therapy did not improve survival . For patients aged 40 - 60 years , there was a statistically significant increase in overall survival when BCNU was added to 60 Gy ( P less than .01 ) , with an increase in 2-year survival from 8 % to 23 % . This beneficial effect of BCNU is apparent in both histological groups ( astrocytoma with atypical or anaplastic foci and glioblastoma multiforme ) . Although few confirmatory autopsies are available , long-term survival in patients with astrocytomas with atypical and anaplastic foci who were treated with 60 Gy plus BCNU ( 5-yr survival , 22 % ) suggests no significant late CNS toxicity , compared to 60 Gy alone ( 5-yr survival , 15 % ) . This is confirmed by comparable neurological function in long-term survivors A controlled , prospect i ve , r and omized study evaluated the use of 1,3-bis(2-chloroethyl)-1-nitrosourea ( BCNU ) and /or radiotherapy in the treatment of patients who were operated on and had histological confirmation of anaplastic glioma . A total of 303 patients were r and omized into this study , of whom 222 ( 73 % ) were within the Valid Study Group ( VSG ) , having met the protocol criteria of neuropathology , corticosteroid control , and therapeutic approach . Patients were divided into four r and om groups , and received BCNU ( 80 mg/sq m/day on 3 successive days every 6 to 8 weeks ) , and /or radiotherapy ( 5000 to 6000 rads to the whole brain through bilateral opposing ports ) , or best conventional care but no chemotherapy or radiotherapy . Analysis was performed on all patients who received any amount of therapy ( VSG ) and on the Adequately Treated Group ( ATG ) , who had received 5000 or more rads radiotherapy , two or more courses of chemotherapy , and had a minimum survival of 8 or more weeks ( the interval that would have been required to have received either the radiotherapy or chemotherapy ) . Median survival of patients in the VSG was , best conventional care : 14 weeks ( ATG : 17.0 weeks ) ; BCNU : 18.5 weeks ( ATG : 25.0 weeks ) ; radiotherapy : 35 weeks ( ATG : 37.5 weeks ) ; and BCNU plus radiotherapy : 34.5 weeks ( ATG : 40.5 weeks ) . All therapeutic modalities showed some statistical superiority compared to best conventional care . There was no significant difference between the four groups in relation to age distribution , sex , location of tumor , diagnosis , tumor characteristics , signs or symptoms , or the amount of corticosteroid used . An analysis of prognostic factors indicates that the initial performance status ( Karnofsky rating ) , age , the use of only a surgical biopsy , parietal location , the presence of seizures , or the involvement of cranial nerves II , III , IV , and VI are all of significance . Toxicity included acceptable , reversible thrombocytopenia and leukopenia An attempt was made to evaluate the potential advantages of chemotherapy in the treatment of 62 patients with glioblastoma . Twenty-four of the 62 patients received adjuvant nitrosourea chemotherapy with carmustine ( BCNU ) , lomustine ( CCNU ) , or semustine ( methyl CCCNU ) in addition to surgery and radiotherapy . Thirty-three of the 62 patients were involved in a controlled , prospect i ve , r and omly allocated study . Quality or quantity of survival was not prolonged in patients who received chemotherapy . Age greater than 64 years , a severe postoperative neurological deficit , or the onset of symptoms less than 12 months prior to surgery were associated with a worse prognosis . The valid evaluation of the effect of a form of treatment on survival in patients with glioblastoma is contingent on the regorous avoidance of preselected factors that may predispose the treated group to a more favorable prognosis This prospect i ve and r and omized trial reports the effects of three chemotherapeutic regimens on three different clinical parameters in adults with supratentorial malignant brain gliomas : 1 ) duration of the interval between surgery and relapse ( the " free interval " ) ; 2 ) total survival time ; and 3 ) rate and length of objective remissions . All patients were irradiated with 5500 to 6000 rads after neurosurgery aim ed at an optimum removal . The administration of VM-26 , 60 mg/sq m on Day 1 , plus CCNU , 130 mg/sq m on Day 2 , repeated every 6 weeks , had no significant effect on the length of the free interval between surgery and relapse . Thus , the median duration of this period was 39 weeks in the group of 61 patients who received adjuvant chemotherapy and 30 weeks in 55 controls without treatment . Neither was the total survival time prolonged by the administration of early chemotherapy . The best prognostic factor for the duration of the free interval and survival was age : patients under 50 years old survived statistically significantly longer . The rate of the objective remission , defined as a clear-cut clinical improvement persisting 6 weeks after complete discontinuation of steroids , was measured after tumor relapse . In patients who were not previously treated with chemotherapy , CCNU alone or VM-26 plus CCNU produced objective remissions in only 15 % of treated patients . Out of 17 cases treated previously by VM-26 plus CCNU , none responded to procarbazine after relapse Forty-one consecutive patients with supratentorial primary brain tumors ( 38 Grade III and IV astrocytomas , one giant-cell astrocytoma , and two cases with insufficient tissue for diagnosis ) were r and omly allocated within 2 weeks of surgery to one of three therapeutic groups . Group 1 ( 15 patients ) received radiation therapy totaling 4000 to 4500 rads in 4 to 5 weeks . Group 2 ( 13 patients ) received 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea CCNU ) 130 mg/sq m orally every 6 weeks . Group 3 ( 13 patients ) received radiation therapy plus CCNU as for Groups 1 and 2 . When the disease progressed , patients in Groups 1 and 2 were crossed over to receive CCNU and irradiation respectively . The median survival time in these groups was 188 , 259 , and 252 days , and the mean survival 263 , 262 , and 329 days . The median time from diagnosis to crossover ( Groups 1 and 2 ) or to progression ( Group 3 ) was 163 , 99 , and 220 days , and the mean time was 172 , 108 , and 231 days . There was no statistically significant difference between the means or medians in any of these situations From September , 1972 to December , 1976 , 102 consecutive patients operated on for glioblastoma multiforme were r and omized , after total or subtotal tumor resection , to receive irradiation alone , irradiation plus BCNU or irradiation plus CCNU . BCNU and CCNU adjuvant chemotherapy was repeated every 6 - -8 weeks as long as the patients remained in complete remission . Patients were comparable for median age , type of surgery , and histological grade III and IV . Radiotherapy was administered at the tumor dose of about 5000 rads in all three groups . The percent of optimal dose administered was 96 % for BCNU and 93 % for CCNU . In the group treated with radiotherapy alone ( 32 cases ) the median survival was 10.5 months , while in the groups treated with BCNU ( 34 cases ) and CCNU ( 36 cases ) the median survival was 12 and 16 months , respectively . Both relapse-free ( P = 0.05 ) and total survival ( P = 0.03 ) were significantly improved only in patients who were treated with radiotherapy plus CCNU compared to patients receiving radiotherapy alone after surgery . Present results show that in resectable glioblastoma multiforme , a slightly improved survival rate can be achieved by the prolonged use of adjuvant CCNU following maximal surgical resection and radiotherapy . The cure rate was not improved BACKGROUND A r and omised controlled trial of radiotherapy alone versus radiotherapy with concomitant and adjuvant temozolomide for patients with glioblastoma showed that survival was higher for patients assigned combination treatment compared with those assigned st and ard radiotherapy alone . This paper reports the health-related quality of life ( HRQOL ) of the patients in this trial . METHODS 573 patients with newly diagnosed glioblastoma were r and omly allocated either radiotherapy alone or radiotherapy and temozolomide . The primary endpoint was survival , and HRQOL was a secondary endpoint . We assessed HRQOL at baseline and at every 3 months during treatment until progression using the European Organisation for Research and Treatment of Cancer ( EORTC ) quality of life question naire core-30 ( QLQ-C30 ) and the EORTC brain cancer module ( EORTC BN-20 ) . We calculated changes from baseline score for seven predefined HRQOL measures ( fatigue , overall health , social function , emotional function , future uncertainty , insomnia , and communication deficit ) and differences between groups for these measures at every time point . The significance of , and proportions of patients with , improved HRQOL scores -- defined as a change of 10 points or more -- were recorded . This trial is registered on the US National Cancer Institute website http://www.cancer.gov/ search /New Clinical Trials , NCT00006353 . FINDINGS Baseline question naires were available for 490 ( 86 % ) patients . Baseline HRQOL scores did not differ between groups . At first follow-up , groups differed only in social functioning , favouring the radiotherapy-only group ( mean score 79.0 [ SD 3.2 ] for patients assigned radiotherapy vs 67.4 [ 2.7 ] for those assigned radiotherapy and temozolomide ; difference between groups 11.6 points [ 95 % CI 3.5 - 19.7 ] , p=0.0052 ) . Over subsequent assessment s , HRQOL was much the same between treatment groups . INTERPRETATION Addition of temozolomide during and after radiotherapy for patients with newly diagnosed glioblastoma significantly improved survival without a negative effect on HRQOL The authors report 63 patients with biopsy-proved malignant ( Grade s 3 and 4 ) astrocytomas who were r and omly placed in one of three treatment schedules within 2 weeks of surgery . One group ( 22 patients ) received radiation therapy alone ; the second group ( 22 patients ) received 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea ( CCNU ) orally at intervals of 8 weeks ; and the third group ( 19 patients ) received combined radiation and drug therapy . Patients who received radiation therapy , with or without the drug , had a significantly longer survival than did those who received the drug alone . There was no difference in survival between the two groups who received radiation . The nitrosourea derivative CCNU does not seem to be an effective agent in the therapy of primary malignant brain tumors Dianhydrogalactitol was the most active of 177 agents tested against a mouse ependymoblastoma tumor . We conducted a prospect ively r and omized trial comparing whole-brain irradiation alone vs identical irradiation plus dianhydrogalactitol in 42 patients with grade 3 and 4 supratentorial astrocytomas . Patients receiving dianhydrogalactitol in addition to irradiation had a significantly longer median survival time ( 67 vs 35 weeks ) than did patients receiving only irradiation . The major toxic effect of dianhydrogalactitol is hematologic suppression of a cumulative nature . Dianhydrogal
Output:
| CONCLUSION Concomitant temozolomide during radiotherapy and post-radiation adjuvant temozolomide is recommended for all patients ages 18 - 70 with newly diagnosed glioblastoma multiforme who are fit for radical therapy ( ECOG 0 - 1 ) .
Temozolomide may be considered in other situations ( i.e. , ECOG 2 , biopsy only , age > 70 , intermediate grade glioma ) , but there is no high-level evidence to support this decision .
Moreover , there are few data on long-term toxicities or quality of life with temozolomide .
Adjuvant chemotherapy may be an option for younger patients with anaplastic ( grade 3 ) astrocytoma and patients with pure or mixed oligodendroglioma . |
MS213137 | ***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 — Cardiac stress testing in patients at low risk for acute coronary syndrome is associated with increased false-positive test results , unnecessary downstream procedures , and increased cost . We judged it unlikely that patient preferences were driving the decision to obtain stress testing . Methods and Results — The Chest Pain Choice trial was a prospect i ve r and omized evaluation involving 204 patients who were r and omized to a decision aid or usual care and were followed for 30 days . The decision aid included a 100-person pictograph depicting the pretest probability of acute coronary syndrome and available management options ( observation unit admission and stress testing or 24–72 hours outpatient follow-up ) . The primary outcome was patient knowledge measured by an immediate postvisit survey . Additional outcomes included patient engagement in decision making and the proportion of patients who decided to undergo observation unit admission and cardiac stress testing . Compared with usual care patients ( n=103 ) , decision aid patients ( n=101 ) had significantly greater knowledge ( 3.6 versus 3.0 questions correct ; mean difference , 0.67 ; 95 % CI , 0.34–1.0 ) , were more engaged in decision making as indicated by higher OPTION ( observing patient involvement ) scores ( 26.6 versus 7.0 ; mean difference , 19.6 ; 95 % CI , 1.6–21.6 ) , and decided less frequently to be admitted to the observation unit for stress testing ( 58 % versus 77 % ; absolute difference , 19 % ; 95 % CI , 6%–31 % ) . There were no major adverse cardiac events after discharge in either group . Conclusions — Use of a decision aid in patients with chest pain increased knowledge and engagement in decision making and decreased the rate of observation unit admission for stress testing . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01077037 PURPOSE To examine the impact of a personal health record ( PHR ) in patients with hypertension measured by changes in biological outcomes , patient empowerment , patient perception of quality of care , and use of medical services . METHODS A cluster-r and omized effectiveness trial with PHR and no PHR groups was conducted in two ambulatory clinics . 453 of 1686 ( 26.4 % ) patients approached were included in the analyses . A PHR tethered to the patient 's electronic medical record ( EMR ) was the primary intervention and included security measures , patient control of access , limited transmission of EMR data , blood pressure ( BP ) tracking , and appointment assistance . BP was the main outcome measure . Patient empowerment was assessed using the Patient Activation Measure and Patient Empowerment Scale . Quality of care was assessed using the Clinician and Group Assessment Score ( CAHPS ) and the Patient Assessment of Chronic Illness Care . Frequency of use of medical services was self-reported . RESULTS No impact of the PHR was observed on BP , patient activation , patient perceived quality , or medical utilization in the intention-to-treat analysis . Sub- analysis of intervention patients self-identified as active PHR users ( 25.7 % of those with available information ) showed a 5.25-point reduction in diastolic BP . Younger age , self-reported computer skills , and more positive provider communication ratings were associated with frequency of PHR use . CONCLUSIONS Few patients provided with a PHR actually used the PHR with any frequency . Thus simply providing a PHR may have limited impact on patient BP , empowerment , satisfaction with care , or use of health services without additional education or clinical intervention design ed to increase PHR use . CLINICAL TRIAL REGISTRATION NUMBER http:// Clinical Trials.gov Identifier : NCT01317537 Decision aids in North American breast cancer out patients have been shown to assist with treatment decision making and reduce decisional conflict . To date , appropriate delivery formats to effectively increase patient participation in newly diagnosed breast cancer in patients have not been investigated in the context of German health care provision . The impact of a decision aid intervention was studied in patients ( n=111 ) with a strong suspicion of breast cancer in a r and omised controlled trial . The primary outcome variable was decisional conflict . Participants were followed up 1 week post-intervention with a retention rate of 92 % . Analyses revealed that the intervention group felt better informed ( ηp2=0.06 ) but did not experience an overall reduction in decisional conflict as compared with the control group . The intervention had no effect on uptake rates of treatment options , length of consultation with the surgeon , time point of treatment decision making , perceived involvement in decision making , neither decision related nor general patient satisfaction . Patients who received the decision aid intervention experienced a small benefit with regards to how informed they felt about advantages and disadvantages of relevant treatment options . Results are discussed in terms of context ual factors and individual differences as moderators of treatment decision aid effectiveness Background —Percutaneous coronary intervention ( PCI ) for stable coronary artery disease does not reduce the risk of death and myocardial infa rct ion compared with optimal medical therapy ( OMT ) , but many patients think otherwise . PCI Choice , a decision aid ( DA ) , was design ed for use during the clinical visit and includes information on quality of life and mortality outcomes for PCI with OMT versus OMT alone for stable coronary artery disease . Methods and Results —We conducted a r and omized trial to assess the impact of the PCI Choice DA compared with usual care when there is a choice between PCI and optimal medical therapy . Primary outcomes were patient knowledge and decisional conflict , and the secondary outcome was an objective measure of shared decision making . A total of 124 patients were eligible for final analysis . Knowledge was higher among patients receiving the DA compared with usual care ( 60 % DA ; 40 % usual care ; P=0.034 ) , and patients felt more informed ( P=0.043 ) . Other measures of decisional quality were not improved , and engagement of the patient by the clinician in shared decision making did not change with use of the DA . There was evidence that clinicians used the DA as an educational tool . Conclusions —The PCI Choice DA improved patient knowledge but did not significantly impact decisional quality . Further work is needed to effectively address clinician knowledge gaps in shared decision-making skills , even in the context of carefully design ed DAs . Clinical Trial Registration —URL : https://www . clinical trials.gov/. Unique identifier : NCT01771536 Background Professional societies recommend shared decision making ( SDM ) for prostate cancer screening , however , most efforts have promoted informed rather than shared decision making . The objective of this study is to 1 ) examine the effects of a prostate cancer screening intervention to promote SDM and 2 ) determine whether framing prostate information in the context of other clearly beneficial men ’s health services affects decisions . Methods We conducted two separate r and omized controlled trials of the same prostate cancer intervention ( with or without additional information on more clearly beneficial men ’s health services ) . For each trial , we enrolled a convenience sample of 2 internal medicine practice s , and their interested physicians and male patients with no prior history of prostate cancer ( for a total of 4 practice s , 28 physicians , and 128 men across trials ) . Within each practice site , we r and omized men to either 1 ) a video-based decision aid and research er-led coaching session or 2 ) a highway safety video . Physicians at each site received a 1-hour educational session on prostate cancer and SDM . To assess intervention effects , we measured key components of SDM , intent to be screened , and actual screening . After finding that results did not vary by trial , we combined data across sites , adjusting for the r and om effects of both practice and physician . Results Compared to an attention control , our prostate cancer screening intervention increased men ’s perceptions that screening is a decision ( absolute difference + 41 % ; 95 % CI 25 to 57 % ) and men ’s knowledge about prostate cancer screening ( absolute difference + 34 % ; 95 % CI 19 % to 50 % ) , but had no effect on men ’s self-reported participation in shared decisions or their participation at their preferred level . Overall , the intervention decreased screening intent ( absolute difference −34 % ; 95 % CI −50 % to −18 % ) and actual screening rates ( absolute difference −22 % ; 95 % CI −38 to −7 % ) with no difference in effect by frame . Conclusions SDM interventions can increase men ’s knowledge , alter their perceptions of prostate cancer screening , and reduce actual screening . However , they may not guarantee an increase in shared decisions . Trial registration # Background Patient-centered diabetes care requires shared decision making ( SDM ) . Decision aids promote SDM , but their efficacy in nonacademic and rural primary care clinics is unclear . Methods We cluster-r and omized 10 practice s in a concealed fashion to implement either a decision aid ( DA ) about starting statins or one about choosing antihyperglycemic agents . Each practice served as a control group for another practice implementing the other type of DA . From April 2011 to July 2012 , 103 ( DA=53 ) patients with type 2 diabetes participated in the trial . We used patient and clinician surveys administered after the clinical encounter to collect decisional outcomes ( patient knowledge and comfort with decision making , patient and clinician satisfaction ) . Medical records provided data on metabolic control . Pharmacy fill profiles provided data for estimating adherence to therapy . Results Compared to usual care , patients receiving the DA were more likely to report discussing medications ( 77 % vs. 45 % , p<.001 ) , were more likely to answer knowledge questions correctly ( risk reduction with statins 61 % vs. 33 % , p=.07 ; knowledge about options 57 % vs. 33 % , p=.002 ) and were more engaged by their clinicians in decision making ( 50 . vs. 28 , difference 21.4 ( 95 % CI 6.4 , 36.3 ) , p=.01 ) . We found no significant impact on patient satisfaction , medication starts , adherence or clinical outcomes , in part due to limited statistical power . Conclusion DAs improved decisional outcomes without significant effect on clinical outcomes . DAs design ed for point-of-care use with type 2 diabetes patients promoted shared decision making in nonacademic and rural primary care practice s . Trial Registration OBJECTIVE To test the effect of three questions ( what are my options ? what are the benefits and harms ? and how likely are these ? ) , on information provided by physicians about treatment options . METHODS We used a cross-over trial using two unannounced st and ardized patients ( SPs ) simulating a presentation of mild-moderate depression . One SP was assigned the intervention role ( asking the questions ) , the other the control role . An intervention and control SP visited each physician , order allocated r and omly . The study was conducted in family practice s in Sydney , Australia , during 2008 - 09 . Data were obtained from consultation audio-recordings . Information about treatment options and patient involvement were analyzed using the Assessing Communication about Evidence and Patient Preferences ( ACEPP ) tool and the OPTION tool . RESULTS Thirty-six SP visits were completed ( 18 intervention , 18 control ) . Scores were higher in intervention consultations than controls : ACEPP scores 21.4 vs. 16.6 , p<0.001 , difference 4.7 ( 95 % CI 2.3 - 7.0 ) and OPTION scores 36 vs. 25 , p=0.001 , difference 11.5 ( 95 % CI 5.1 - 17.8 ) , indicating greater information provision and behavior supporting patient involvement . CONCLUSION Asking these three questions improved information given by family physicians and increased physician facilitation of patient involvement . Practice implication s. These questions can drive evidence -based practice , strengthen patient-physician communication , and improve safety and quality Purpose . To conduct a pilot test of a decision aid design ed to help patients choose among currently recommended colorectal cancer screening programs . Methods . R and omized controlled trial comparing a patient decision aid based on multi criteria decision-making theory with a simple educational intervention . Patient population . 96 patients at average risk for colorectal cancer seen in an Internal Medicine practice in Rochester , New York . Outcome measures . The two primary outcome measures were patient decision process and the decision outcome . Patient decision process was assessed using the decisional conflict scale . Decision outcome was defined as the proportion of colorectal cancer screening plans carried out . Results . After controlling for the effects of the physicians in a factorial analysis of variance , patients who used the decision aid had lower decisional conflict regarding colorectal cancer screening decisions ( F ratio6.47 , P = 0.01 ) due to increased knowledge , better clarity of values , and higher ratings of the quality of the decisions they made . There was no difference between the groups in decision outcomes : 52 % of patients in the control group and 49 % in the experimental group completed planned screening tests ( P = 1.0 ) . Conclusions . In a pilot study , a multi criteria -based patient decision aid for colorectal cancer screening improved patients ’ decision-making processes but had no effect on the implementation of screening plans Purpose Many patients with schizophrenia have a desire for shared decision-making ( SDM ) . However , in clinical practice SDM often does not take place . One cause might be that many patients behave passively in the medical encounter , therefore not facilitating SDM . It was the aim of the study to evaluate the effects of a patient directed SDM-training on patients ’ communicative behavior in the consultation , their attitudes towards decision-making and their long-term adherence . Methods R and omized-controlled trial comparing a five-session SDM-training for in patients with schizophrenia with five sessions of non-specific group training . The SDM-training sessions included motivational ( e.g. prospect s of participation , patient rights ) and behavioral aspects ( e.g. role plays ) and addressed important aspects of the patient – doctor interaction such as question asking or giving feedback . Results N = 264 patients were recruited in four psychiatric hospitals in Germany . The SDM-training yielded no group differences regarding the main outcome measure ( treatment adherence ) at 6 and 12
Output:
| There was insuffient information to determine the effects on decision regret , physical or mental health-related quality of life , or consultation length or costs . |
MS213138 | ***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: Rheumatoid arthritis ( RA ) is associated with high rates of cardiovascular events mainly due to coronary and cerebrovascular atherosclerotic disease . Asymmetric ( ADMA ) and symmetric ( SDMA ) dimethylarginines are endogenous inhibitors of nitric oxide synthase and have been repeatedly linked with adverse cardiovascular outcomes in the general population and various disease setting s. Alanine – glyoxylate aminotransferase 2 ( AGTX2 ) is considered an alternative metabolic pathway contributing to the clearance of dimethylarginines in humans . The aim of the current study was to investigate the effect of specific AGXT-2 gene polymorphisms on circulating levels of ADMA or SDMA in patients with RA . Serum ADMA and SDMA levels were measured in 201 individuals with RA [ median age : 67 years ( IQR : 59–73 ) , 155 females ] . Two single nucleotide polymorphisms ( SNPs ) in the AGXT-2 gene — rs37369 and rs28305—were genotyped . Distributions of SDMA and ADMA were skewed , hence comparisons across the gene polymorphisms were performed using Kruskal – Wallis tests , and summarized using medians and interquartile ranges . Univariable analysis did not demonstrate a significant difference in the levels of SDMA or ADMA amongst the different genotypic groups of either rs37369AGXT2 ( p = 0.800 , 0.977 ) or rs28305AGXT2 ( p = 0.463 , 0.634 ) . In multivariable analyses , ADMA levels were found to be significantly associated with erythrocyte sedimentation rate and estimated glomerular filtration rate , whilst SDMA levels were significantly associated with estimated glomerular filtration rate and quantitative insulin sensitivity check index . After adjustments for these factors , the relationship between the AGXT2 gene variants and both ADMA and SDMA remained non-significant . Our study in a well-characterized RA population did not show an association between serum concentrations of dimethylarginines and genetic variants of the AGXT2 gene BACKGROUND Asymmetric dimethylarginine ( ADMA ) is associated with endothelial injury . Increased ADMA levels are found in rheumatoid arthritis ( RA ) and ankylosing spondylitis ( AS ) . We set out to assess the ADMA and symmetric dimethylarginine ( SDMA ) levels in AS , RA , and healthy controls , and in the anti-TNF treated patients with active AS . METHODS In 78AS patients and 29 RA patients who were anti-TNF treatment naive at baseline , along with 23 healthy control subjects , we assessed erythrocyte sedimentation rate ( ESR ) , high-sensitivity C-reactive protein ( hsCRP ) , ADMA , and SDMA . For AS patients , the Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , back pain VAS and patient 's global activity of disease were calculated . After 6 months , we repeated the assessment in 30 out of the 78 AS patients in whom the anti-TNF treatment was initiated . RESULTS The baseline mean ( SD ) plasma ADMA concentration of AS patients was 0.64 ( 0.19 ) μmol/l and did not differ from controls ( 0.65 [ 0.19 ] μmol/l , p > 0.05 ) . In the RA group , ADMA concentration was higher than in controls ( 0.77 vs. 0.65 μmol/l , p < 0.05 ) . Both at baseline and at follow-up , ADMA levels correlated positively with BASDAI ( R = 0.52 , p = 0.02 , and R = 0.47 , p = 0.04 , baseline and follow-up , respectively ) . Six months of anti-TNF treatment did not influence ADMA concentration ( 0.51 [ 0.12 ] vs. 0.51 [ 0.11 ] μmol/l , p = 0.70 ) . CONCLUSION An absence of changes in plasma ADMA levels in the anti-TNF treated AS group despite the improvement in disease activity ( BASDAI ) and inflammation ( ESR , CRP ) may suggest either a lack of effect , or , even if such an effect were to take place , it needs not imply measurable changes in blood ADMA We explored the role of asymmetrical dimethylarginine ( ADMA ) as a cause of endothelial dysfunction induced by systemic inflammation . In vitro data suggest that ADMA bioavailability is regulated by proinflammatory stimuli , but it is unclear whether ADMA is a link between inflammation and endothelial dysfunction in humans . In study 1 we recruited 351 patients with coronary artery disease ( CAD ) and 87 healthy controls . In study 2 we recruited 69 CAD , 69 healthy , and 10 patients with rheumatoid arthritis , whereas in study 3 , 22 healthy and 70 CAD subjects were r and omly assigned to Salmonella typhii vaccination ( n=11 healthy and n=60 CAD ) or placebo ( n=11 healthy and n=10 CAD ) . Circulating interleukin 6/ADMA and flow-mediated dilation ( FMD ) were measured at 0 and 8 hours . In study 1 , ADMA was inversely correlated with FMD in healthy individuals and CAD patients ( P<0.0001 for both ) . However , interleukin 6 was inversely correlated with FMD ( P<0.0001 ) in healthy subjects but not in CAD patients . The positive correlation between ADMA and interleukin 6 was stronger in healthy ( r=0.515 ; P<0.0001 ) compared with CAD ( r=0.289 ; P=0.0001 ) subjects . In study 2 , both patients with rheumatoid arthritis and CAD had higher interleukin 6 ( P<0.0001 ) and ADMA ( P=0.004 ) but lower FMD ( P=0.001 ) versus healthy subjects . In study 3 , vaccination increased interleukin 6 in healthy ( P<0.001 ) and CAD ( P<0.001 ) subjects . FMD was reduced in healthy subjects ( P<0.05 ) , but its reduction in CAD was borderline . Vaccination increased ADMA only in healthy subjects ( P<0.001 ) . Systemic , low- grade inflammation leads to increased ADMA that may induce endothelial dysfunction . This study demonstrated that ADMA may be a link between inflammation and endothelial dysfunction in humans OBJECTIVE The aim of the present study was to investigate the associations of cumulative inflammatory burden ( assessed by serial measurements of inflammatory markers ) and classical cardiovascular disease ( CVD ) risk factors with asymmetric dimethylarginine ( ADMA ) in a large prospect i ve cohort of patients with established RA . METHODS Two hundred and one RA patients [ 155 females , median age 67 years ( range 59 - 73 ) ] were assessed at baseline ( 2006 ) for the presence of classical CVD risk factors and determination of systemic inflammation by CRP and ESR . Global CVD risk was identified by the Framingham Risk Score and the Reynolds Risk Score . At follow-up ( 2012 ) , ADMA levels were measured by ELISA . A quarterly measurement of CRP and ESR for each year the patient was in the study was used to produce an average area under the curve ( AAUC ) for ESR and CRP . RESULTS Regression analysis revealed that baseline ESR in 2006 and the AAUC of ESR and CRP all had significant positive relationships with current ADMA ( P = 0.004 , P < 0.001 and P = 0.002 , respectively ) . Baseline CRP in 2006 was not a significant predictor of ADMA ( P = 0.093 ) , although this relationship was in the same direction as the other factors . These results remained consistent after adjustment for classical CVD risk factors . CONCLUSION Cumulative inflammatory burden is positively associated with ADMA levels , suggesting a potential pathogenic mechanism through which chronic systemic inflammation exerts deleterious effects on nitric oxide metabolism and endothelial homeostasis . This association is independent of classical CVD risk factors OBJECTIVES The present study was design ed to test the hypothesis that long-term dietary supplementation with the nitric oxide precursor L-arginine would enhance vascular or platelet-derived nitric oxide activity , or both , and thereby inhibit platelet reactivity in hypercholesterolemic humans . BACKGROUND We have shown that reduced vascular activity of nitric oxide in hypercholesterolemic rabbits can be restored by L-arginine supplementation . The improvement in nitric oxide activity is associated with an inhibition of platelet aggregation ex vivo . This effect is most likely due to increased elaboration of endothelium- or platelet-derived nitric oxide , or both , because the inhibition of platelet reactivity was associated with elevation of intraplatelet cyclic guanosine monophosphate and was reversed by the nitric oxide synthase antagonist N-methyl-arginine . METHODS In a double-blinded , r and omized , placebo-controlled trial , hypercholesterolemic patients were assigned to L-arginine hydrochloride , 8.4 g/day orally , or placebo for 2 weeks . Platelet-rich plasma was obtained for aggregometry induced by collagen ( 1 to 10 micrograms/ml ) at four points : baseline , after 2 weeks of treatment , after a 2-week washout and after a long-term washout of 16 weeks on average . Aggregation was quantified by light transmittance and expressed as a percent transmittance observed with platelet-poor plasma . RESULTS Compared with normocholesterolemic control subjects , platelets from hypercholesterolemic subjects stimulated with 5 micrograms/ml of collagen showed increased aggregability ( 68.6 % in hypercholesterolemic patients vs. 54.5 % in normocholesterolemic control subjects , p < or = 0.02 ) . After 2 weeks of treatment with L-arginine ( but not placebo ) , platelet reactivity was modestly reduced ; this effect persisted for 2 weeks after discontinuation of arginine ( 52.6 % in arginine-treated patients vs. 65.1 % in normocholesterolemic control subjects , p = 0.07 ) . After 18 weeks ( i.e. , 16 weeks after discontinuing arginine treatment ) , the platelets of hypercholesterolemic patients once again became hyperaggregable , and the extent of platelet aggregation was significantly increased compared with the 4-week point ( 73.6 % after vs. 52.6 % during arginine treatment , p < 0.01 ) . No significant change in platelet reactivity was seen in placebo-treated hypercholesterolemic patients throughout the study . L-Arginine treatment was well tolerated without side effects . CONCLUSIONS This double-blinded , placebo-controlled study demonstrates that dietary supplementation with L-arginine can modestly attenuate the increased platelet reactivity seen in hypercholesterolemic patients . The data are consistent with our previous studies in hypercholesterolemic animals , demonstrating that L-arginine restores endogenous nitric oxide activity and inhibits platelet aggregation . Enhancement of endogenous nitric oxide activity is a potential novel therapeutic strategy worthy of further study Objectives . Impaired endothelial function represents the early stage of atherosclerosis , which is typically associated with systemic inflammatory diseases like rheumatoid arthritis ( RA ) . As modulators of endothelial nitric oxide synthase expression , asymmetric-dimethylarginine ( ADMA ) and apelin might be measured in the blood of RA patients to detect early atherosclerotic changes . We conducted a prospect i ve , case-control study to investigate serum ADMA and apelin profiles of patients with early-stage RA ( ERA ) before and after disease-modifying antirheumatic drug ( DMARD ) therapy . Methods . We enrolled 20 consecutively diagnosed , treatment-naïve patients with ERA and 20 matched healthy controls . Serum ADMA and apelin levels and the 28-joint disease activity scores ( DAS28 ) were assessed before and after 12 months of DMARDs treatment . All patients underwent ultrasonographic assessment for intima-media tickness ( IMT ) evaluation . Results . In the ERA group , ADMA serum levels were significantly higher than controls at baseline ( P = 0.007 ) and significantly decreased after treatment ( P = 0.012 versus controls ) . Baseline serum apelin levels were significantly decreased in this group ( P = 0.0001 versus controls ) , but they were not significantly altered by treatment . IMT did not show significant changes . Conclusions . ERA is associated with alterations of serum ADMA and apelin levels , which might be used as biomarkers to detect early endothelial dysfunction in these patients Chronic inflammatory diseases such as rheumatoid arthritis ( RA ) are associated with accelerated atherosclerosis and increased morbidity and mortality for cardiovascular events . Asymmetric dimethyl arginine ( ADMA ) , an endogenous inhibitor of nitric oxide synthase , contributes to the impairment of endothelial function , the earlier and reversible stage of atherosclerotic plaque formation . Since tumor necrosis factor ( TNF ) inhibits enzymatic degradation of ADMA , anti-TNF agents could restore its physiological level .
Output:
| Circulating ADMA levels are higher in RA patients compared with healthy controls .
In addition , ADMA levels are influenced by age , disease duration and disease activity |
MS213139 | ***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 Afghanistan 's national guidelines recommend chloroquine for the treatment of Plasmodium vivax infection , the parasite responsible for the majority of its malaria burden . Chloroquine resistance in P. vivax is emerging in Asia . Therapeutic responses across Afghanistan have not been evaluated in detail . Methods Between July 2007 and February 2009 , an open-label , r and omized controlled trial of chloroquine and dihydroartemisinin-piperaquine in patients aged three months and over with slide-confirmed P. vivax mono-infections was conducted . Consistent with current national guidelines , primaquine was not administered . Subjects were followed up daily during the acute phase of illness ( days 0 - 3 ) and weekly until day 56 . The primary endpoint was the overall cumulative parasitological failure rate at day 56 after the start of treatment , with the hypothesis being that dihydroartemisinin-piperaquine was non-inferior compared to chloroquine ( Δ = 5 % difference in proportion of failures ) . Results Of 2,182 individuals with positive blood films for P. vivax , 536 were enrolled in the trial . The day 28 cure rate was 100 % in both treatment groups . Parasite clearance was more rapid with dihydroartemisinin-piperaquine than chloroquine . At day 56 , there were more recurrent infections in the chloroquine arm ( 8.9 % , 95 % CI 6.0 - 13.1 % ) than the dihydroartemisinin-piperaquine arm ( 2.8 % , 95 % CI 1.4 - 5.8 % ) , a difference in cumulative recurrence rate of 6.1 % ( 2-sided 90%CI + 2.6 to + 9.7 % ) . The log-rank test comparing the survival curves confirmed the superiority of dihydroartemisinin-piperaquine over chloroquine ( p = 0.003 ) . Multivariate analysis showed that a lower initial haemoglobin concentration was also independently associated with recurrence . Both regimens were well tolerated and no serious adverse events were reported . Conclusions Chloroquine remains an efficacious treatment for the treatment of vivax malaria in Afghanistan . In a setting where radical therapy can not be administered , dihydroartemisinin-piperaquine provides additional benefit in terms of post-treatment prophylaxis , reducing the incidence of recurrence from 4 - 8 weeks after treatment . Trial Registration The trial was registered at Clinical Trials.gov under identifier NCT00682578 Background There is general international agreement that the importance of vivax malaria has been neglected , and there is a need for new treatment approaches in an effort to progress towards control and elimination in Latin America . This open label r and omized clinical trial evaluated the efficacy and safety of three treatment regimens using either one of two fixed dose artemisinin-based combinations or chloroquine in combination with a short course of primaquine ( 7–9 days : total dose 3–4.2 mg/kg ) in Brazil . The primary objective was establishing whether cure rates above 90 % could be achieved in each arm . Results A total of 264 patients were followed up to day 63 . The cure rate of all three treatment arms was greater than 90 % at 28 and 42 days . Cure rates were below 90 % in all three treatment groups at day 63 , although the 95 % confidence interval included 90 % for all three treatments . Most of the adverse events were mild in all treatment arms . Only one of the three serious adverse events was related to the treatment and significant drops in haemoglobin were rare . Conclusion This study demonstrated the efficacy and safety of all three regimens that were tested with 42-day cure rates that meet World Health Organization criteria . The efficacy and safety of artemisinin-based combination therapy regimens in this population offers the opportunity to treat all species of malaria with the same regimen , simplifying protocol s for malaria control programmes and potentially contributing to elimination of both vivax and falciparum malaria . Trial registration BACKGROUND Antimalarial drug resistance is now well established in both Plasmodium falciparum and Plasmodium vivax . In southern Papua , Indonesia , where both strains of plasmodia coexist , we have been conducting a series of studies to optimize treatment strategies . METHODS We conducted a r and omized trial that compared the efficacy and safety of dihydroartemisinin-piperaquine ( DHP ) with artesunate-amodiaquine ( AAQ ) . The primary end point was the overall cumulative parasitological failure rate at day 42 . RESULTS Of the 334 patients in the evaluable patient population , 185 were infected with P. falciparum , 80 were infected with P. vivax , and 69 were infected with both species . The overall parasitological failure rate at day 42 was 45 % ( 95 % confidence interval [ CI ] , 36%-53 % ) for AAQ and 13 % ( 95 % CI , 7.2%-19 % ) for DHP ( hazard ratio [ HR ] , 4.3 ; 95 % CI , 2.5 - 7.2 ; P<.001 ) . Rates of both recrudescence of P. falciparum infection and recurrence of P. vivax infection were significantly higher after receipt of AAQ than after receipt of DHP ( HR , 3.4 [ 95 % CI , 1.2 - 9.4 ] and 4.3 [ 95 % CI , 2.2 - 8.2 ] , respectively ; P<.001 ) . By the end of the study , AAQ recipients were 2.95-fold ( 95 % CI , 1.2- to 4.9-fold ) more likely to be anemic and 14.5-fold ( 95 % CI , 3.4- to 61-fold ) more likely to have carried P. vivax gametocytes . CONCLUSIONS DHP was more effective and better tolerated than AAQ against multidrug-resistant P. falciparum and P. vivax infections . The prolonged therapeutic effect of piperaquine delayed the time to P. falciparum reinfection , decreased the rate of recurrence of P. vivax infection , and reduced the risk of P. vivax gametocyte carriage and anemia Background The Bangladeshi national treatment guidelines for uncomplicated malaria follow WHO recommendations but without G6PD testing prior to primaquine administration . A prospect i ve observational study was conducted to assess the efficacy of the current antimalarial policy . Methods Patients with uncomplicated malaria , confirmed by microscopy , attending a health care facility in the Chittagong Hill Tracts , Bangladesh , were treated with artemether-lumefantrine ( days 0–2 ) plus single dose primaquine ( 0.75mg/kg on day2 ) for P. falciparum infections , or with chloroquine ( days 0–2 ) plus 14 days primaquine ( 3.5mg/kg total over 14 days ) for P. vivax infections . Hb was measured on days 0 , 2 and 9 in all patients and also on days 16 and 30 in patients with P. vivax infection . Participants were followed for 30 days . The study was registered with the clinical trials website ( NCT02389374 ) . Results Between September 2014 and February 2015 a total of 181 patients were enrolled ( 64 % P. falciparum , 30 % P. vivax and 6 % mixed infections ) . Median parasite clearance times were 22.0 ( Interquartile Range , IQR : 15.2–27.3 ) hours for P. falciparum , 20.0 ( IQR : 9.5–22.7 ) hours for P. vivax and 16.6 ( IQR : 10.0–46.0 ) hours for mixed infections . All participants were afebrile within 48 hours , two patients with P. falciparum infection remained parasitemic at 48 hours . No patient had recurrent parasitaemia within 30 days . Adjusted male median G6PD activity was 7.82U/gHb . One male participant ( 1/174 ) had severe G6PD deficiency ( < 10 % activity ) , five participants ( 5/174 ) had mild G6PD deficiency ( 10–60 % activity ) . The Hb nadir occurred on day 2 prior to primaquine treatment in P. falciparum and P. vivax infected patients ; mean fractional fall in Hb was -8.8 % ( 95%CI -6.7 % to -11.0 % ) and -7.4 % ( 95%CI : -4.5 to -10.4 % ) respectively . Conclusion The current antimalarial policy remains effective . The prevalence of G6PD deficiency was low . Main contribution to haemolysis in G6PD normal individuals was attributable to acute malaria rather than primaquine administration . Trial Registration Clinical Trials.gov Background Recent efforts in malaria control have result ed in great gains in reducing the burden of Plasmodium falciparum , but P. vivax has been more refractory . Its ability to form dormant liver stages confounds control and elimination efforts . To compare the efficacy and safety of primaquine regimens for radical cure , we undertook a r and omized controlled trial in Ethiopia . Methods and findings Patients with normal glucose-6-phosphate dehydrogenase status with symptomatic P. vivax mono-infection were enrolled and r and omly assigned to receive either chloroquine ( CQ ) or artemether-lumefantrine ( AL ) , alone or in combination with 14 d of semi-supervised primaquine ( PQ ) ( 3.5 mg/kg total ) . A total of 398 patients ( n = 104 in the CQ arm , n = 100 in the AL arm , n = 102 in the CQ+PQ arm , and n = 92 in the AL+PQ arm ) were followed for 1 y , and recurrent episodes were treated with the same treatment allocated at enrolment . The primary endpoints were the risk of P. vivax recurrence at day 28 and at day 42 . The risk of recurrent P. vivax infection at day 28 was 4.0 % ( 95 % CI 1.5%–10.4 % ) after CQ treatment and 0 % ( 95 % CI 0%–4.0 % ) after CQ+PQ . The corresponding risks were 12.0 % ( 95 % CI 6.8%–20.6 % ) following AL alone and 2.3 % ( 95 % CI 0.6%–9.0 % ) following AL+PQ . On day 42 , the risk was 18.7 % ( 95 % CI 12.2%–28.0 % ) after CQ , 1.2 % ( 95 % CI 0.2%–8.0 % ) after CQ+PQ , 29.9 % ( 95 % CI 21.6%–40.5 % ) after AL , and 5.9 % ( 95 % CI 2.4%–13.5 % ) after AL+PQ ( overall p < 0.001 ) . In those not prescribed PQ , the risk of recurrence by day 42 appeared greater following AL treatment than CQ treatment ( HR = 1.8 [ 95 % CI 1.0–3.2 ] ; p = 0.059 ) . At the end of follow-up , the incidence rate of P. vivax was 2.2 episodes/person-year for patients treated with CQ compared to 0.4 for patients treated with CQ+PQ ( rate ratio : 5.1 [ 95 % CI 2.9–9.1 ] ; p < 0.001 ) and 2.3 episodes/person-year for AL compared to 0.5 for AL+PQ ( rate ratio : 6.4 [ 95 % CI 3.6–11.3 ] ; p < 0.001 ) . There was no difference in the occurrence of adverse events between treatment arms . The main limitations of the study were the early termination of the trial and the omission of haemoglobin measurement after day 42 , result ing in an inability to estimate the cumulative risk of anaemia . Conclusions Despite evidence of CQ-resistant P. vivax , the risk of recurrence in this study was greater following treatment with AL unless it was combined with a supervised course of PQ . PQ combined with either CQ or AL was well tolerated and reduced recurrence of vivax malaria by 5-fold at 1 y. Trial registration Clinical Trials.gov The efficacy of chloroquine in the treatment of Plasmodium vivax malaria is declining on the Northwestern border of Thail and . This r and omized controlled trial in 500 adults and children shows that dihydroartemisinin-piperaquine is a safe and effective alternative treatment BACKGROUND Plasmodium knowlesi commonly causes severe malaria in Malaysian Borneo , with high case-fatality rates reported . We compared risk , spectrum , and outcome of severe disease from P. knowlesi , Plasmodium falciparum , and Plasmodium vivax and outcomes following introduction of protocol s for early referral and intravenous artesunate for all severe malaria . METHODS From September 2010 to October 2011 we prospect ively assessed nonpregnant patients aged ≥12 years admitted to Queen Elizabeth Hospital ( QEH ) , Sabah , with polymerase chain reaction-confirmed Plasmodium monoinfection .
Output:
| In this study , we observed the risk of P. vivax recurrence at day 42 to be significantly lower following treatment with DP compared with AL , reflecting the longer period of post-treatment prophylaxis ; this risk was reduced substantially by coadministration with PQ .
We found that delaying P. vivax recurrence was associated with a small but significant improvement in haemoglobin .
These results highlight the benefits of PQ radical cure and also the provision of blood-stage antimalarial agents with prolonged post-treatment prophylaxis |
MS213140 | ***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 Acute chest pain ( ACP ) is a leading cause of hospital emergency unit consultation . As there are various underlying conditions , ranging from musculoskeletal disorders to acute coronary syndrome ( ACS ) , thorough clinical diagnostics are warranted . The aim of this prospect i ve study was to assess whether reproducible chest wall tenderness ( CWT ) on palpation in patients with ACP can help to rule out ACS . Methods In this prospect i ve , double-blinded diagnostic study , all consecutive patients assessed in the emergency unit at the University Hospital Zurich because of ACP between July 2012 and December 2013 were included when a member of the study team was present . Reproducible CWT on palpation was the initial step and was recorded before further examinations were initiated . The final diagnosis was adjudicated by a study -independent physician . Results 121 patients ( 60.3 % male , median age 47 years , IQR 34–66.5 years ) were included . The prevalence of ACS was 11.6 % . Non-reproducible CWT had a high sensitivity of 92.9 % ( 95 % CI 66.1 % to 98.8 % ) for ACS and the presence of reproducible CWT ruled out ACS ( p=0.003 ) with a high negative predictive value ( 98.1 % , 95 % CI 89.9 % to 99.7 % ) . Conversely non-reproducible CWT ruled in ACS with low specificity ( 48.6 % , 95 % CI 38.8 % to 58.5 % ) and low positive predictive value ( 19.1 % , 95 % CI 10.6 % to 30.5 % ) . Conclusions This prospect i ve diagnostic study supports the concept that reproducible CWT helps to rule out ACS in patients with ACP in an early stage of the evaluation process . However , ACS and other diagnoses should be considered in patients with a negative CWT test . Trial registration number Clinical Trial.gov : NCT01724996 Background GlycA , a novel protein glycan biomarker of N‐acetyl side chains of acute‐phase proteins , was recently associated with incident cardiovascular disease ( CVD ) in healthy women . Whether GlycA predicts CVD events in the setting of statin therapy in men and women without CVD but with evidence of chronic inflammation is unknown . Methods and Results In the Justfication for the Use of Statins in Prevention : an Intervention Trial Evaluating Rosuvastatin ( JUPITER ) trial ( NCT00239681 ) , participants with low‐density lipoprotein cholesterol < 130 mg/dL and high‐sensitivity C‐reactive protein ( hsCRP ) ≥2 mg/L were r and omized to rosuvastatin 20 mg/day or placebo . GlycA was quantified by nuclear magnetic resonance spectroscopy in 12 527 before r and omization and 10 039 participants at 1 year . A total of 310 first primary CVD events occurred during maximum follow‐up of 5.0 years ( median , 1.9 ) . GlycA changed minimally after 1 year on study treatment : 6.8 % and 4.7 % decrease in the rosuvastatin and placebo groups , respectively . Overall , baseline GlycA levels were associated with increased risk of CVD : multivariable‐adjusted hazard ratio ( HR ) per SD increment , 1.20 ( 95 % CI , 1.08–1.34 ; P=0.0006 ) . After additionally adjusting for hsCRP , this was slightly attenuated ( HR , 1.18 ; 95 % CI , 1.04–1.35 ; P=0.01 ) . On‐treatment GlycA levels were also associated with CVD ; corresponding multivariable‐adjusted HRs per SD before and after additionally adjusting for hsCRP : 1.27 ( 95 % CI , 1.13–1.42 ; P<0.0001 ) and 1.24 ( 95 % CI , 1.07–1.44 ; P=0.004 ) , respectively . Tests for heterogeneity by treatment arm were not significant ( P for interaction , > 0.20 ) . Conclusion In the JUPITER trial , increased levels of GlycA were associated with an increased risk of CVD events independent of traditional risk factors and hsCRP . Clinical Trials Registration URL : http://www . clinical trials.gov . Unique identifier : NCT00239681 BACKGROUND Atorvastatin , rosuvastatin and pitavastatin are available for intensive , aggressive low-density lipoprotein cholesterol (LDL-C)-lowering therapy in clinical practice . The objective of the R and omized Head-to-Head Comparison of Pitavastatin , Atorvastatin , and Rosuvastatin for Safety and Efficacy ( Quantity and Quality of LDL ) ( PATROL ) Trial was to compare the safety and efficacy of atorvastatin , rosuvastatin and pitavastatin head to head in patients with hypercholesterolemia . This is the first prospect i ve r and omized multi-center trial to compare these strong statins ( UMIN Registration No : 000000586 ) . METHODS AND RESULTS Patients with risk factors for coronary artery disease and elevated LDL-C levels were r and omized to receive atorvastatin ( 10mg/day ) , rosuvastatin ( 2.5mg/day ) , or pitavastatin ( 2mg/day ) for 16 weeks . Safety was assessed in terms of adverse event rates , including abnormal clinical laboratory variables related to liver and kidney function and skeletal muscle . Efficacy was assessed by the changes in the levels and patterns of lipoproteins . Three hundred and two patients ( from 51 centers ) were enrolled , and these 3 strong statins equally reduced LDL-C and LDL particles , as well as fast-migrating LDL ( modified LDL ) by 40 - 45 % . Newly developed pitavastatin was non-inferior to the other 2 statins in lowering LDL-C. There were no differences in the rate of adverse drug reactions among the 3 groups , but HbA(1c ) was increased while uric acid was decreased in the atorvastatin and rosuvastatin groups . CONCLUSIONS The safety and efficacy of these 3 strong statins are equal . It is suggested that the use of these 3 statins be completely dependent on physician discretion based on patient background OBJECTIVES The purpose of this study was to determine the efficacy and safety of radial versus femoral access in women undergoing coronary angiography/intervention . BACKGROUND The risk of bleeding and vascular access site complications are higher in women than in men . METHODS In a pre-specified RIVAL ( RadIal Vs femorAL access for coronary intervention ) subgroup analysis , we compared outcomes in women ( n=1,861 ) and men ( n=5,160 ) r and omized to radial versus femoral access . RESULTS Overall , women were at higher risk of major vascular complications compared with men ( 4.7 % vs. 1.7 % ; p<0.0001 ) . Major vascular complications were significantly reduced with radial access in women ( 3.1 % vs. 6.1 % ; hazard ratio [ HR ] : 0.5 ; 95 % confidence interval [ CI ] : 0.32 to 0.78 ; p=0.002 ) and in men ( 0.7 % vs. 2.8 % ; HR : 0.27 ; 95 % CI : 0.17 to 0.45 ; p<0.0001 ; interaction p=0.092 ) . Crossover rates were higher with radial compared with femoral access in women ( 11.1 % vs. 1.9 % ; HR : 5.88 ; p<0.0001 ) and men ( 6.3 % vs. 1.9 % ; HR : 3.32 ; p<0.0001 ; interaction p=0.054 ) . Percutaneous coronary intervention ( PCI ) success rates were similar irrespective of access site ( women : HR : 1.05 ; p=0.471 ; men : HR : 1.00 ; p=0.888 ; interaction p=0.674 ) , with no differences in PCI complications . In multivariable analyses , female sex was an independent predictor of major vascular complications ( HR : 2.39 ; 95 % CI : 1.76 to 3.25 ; p<0.0001 ) . There were consistent findings for women and men , with no difference for the primary composite endpoint of death , myocardial infa rct ion , stroke , and non-coronary artery bypass grafting bleeding ( women : 3.9 % vs. 5.0 % ; HR : 0.77 ; 95 % CI : 0.50 to 1.19 ; men : 3.54 % vs. 3.5 % ; HR : 1.00 ; 95 % CI : 0.75 to -1.34 ; interaction p=0.325 ) . CONCLUSIONS Women undergoing coronary angiography and PCI have a higher risk of vascular access site complications compared with men , and radial access is an effective method to reduce these complications BACKGROUND Statin therapy reduces low-density lipoprotein ( LDL ) cholesterol levels and the risk of cardiovascular events , but whether the addition of ezetimibe , a nonstatin drug that reduces intestinal cholesterol absorption , can reduce the rate of cardiovascular events further is not known . METHODS We conducted a double-blind , r and omized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter ( 1.3 to 2.6 mmol per liter ) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter ( 1.3 to 3.2 mmol per liter ) if they were not receiving lipid-lowering therapy . The combination of simvastatin ( 40 mg ) and ezetimibe ( 10 mg ) ( simvastatin-ezetimibe ) was compared with simvastatin ( 40 mg ) and placebo ( simvastatin monotherapy ) . The primary end point was a composite of cardiovascular death , nonfatal myocardial infa rct ion , unstable angina requiring rehospitalization , coronary revascularization ( ≥30 days after r and omization ) , or nonfatal stroke . The median follow-up was 6 years . RESULTS The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter ( 1.4 mmol per liter ) in the simvastatin-ezetimibe group , as compared with 69.5 mg per deciliter ( 1.8 mmol per liter ) in the simvastatin-monotherapy group ( P<0.001 ) . The Kaplan-Meier event rate for the primary end point at 7 years was 32.7 % in the simvastatin-ezetimibe group , as compared with 34.7 % in the simvastatin-monotherapy group ( absolute risk difference , 2.0 percentage points ; hazard ratio , 0.936 ; 95 % confidence interval , 0.89 to 0.99 ; P=0.016 ) . Rates of prespecified muscle , gallbladder , and hepatic adverse effects and cancer were similar in the two groups . CONCLUSIONS When added to statin therapy , ezetimibe result ed in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes . Moreover , lowering LDL cholesterol to levels below previous targets provided additional benefit . ( Funded by Merck ; IMPROVE-IT Clinical Trials.gov number , NCT00202878 . ) Objectives We prospect ively compared the preventive effects of rosuvastatin and atorvastatin on contrast-induced nephropathy ( CIN ) in patients with chronic kidney disease ( CKD ) undergoing percutaneous coronary intervention ( PCI ) . Methods We enrolled 1078 consecutive patients with CKD undergoing elective PCI . Patients in Group 1 ( n = 273 ) received rosuvastatin ( 10 mg ) , and those in group 2 ( n = 805 ) received atorvastatin ( 20 mg ) . The primary end-point was the development of CIN , defined as an absolute increase in serum creatinine ≥0.5 mg/dL , or an increase ≥25 % from baseline within 48–72 h after contrast medium exposure . Results CIN was observed in 58 ( 5.4 % ) patients . The incidence of CIN was similar in patients pretreated with either rosuvastatin or atorvastatin ( 5.9 % vs. 5.2 % , p = 0.684 ) . The same results were also observed when using other definitions of CIN . Clinical and procedural characteristics did not show significant differences between the two groups ( p>0.05 ) . Additionally , there were no significant inter-group differences with respect to in-hospital mortality rates ( 0.4 % vs. 1.5 % , p = 0.141 ) , or other in-hospital complications . Multivariate logistic regression analysis revealed that rosuv
Output:
| Our systematic review and meta- analysis showed that , compared with the conventional dose , the loading dose of rosuvastatin was more beneficial to patients with ACS in China and is suitable for clinical application . |
MS213141 | ***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 Despite its effectiveness , methadone maintenance is rarely provided in American correctional facilities . This study is the first r and omized clinical trial in the US to examine the effectiveness of methadone maintenance treatment provided to prisoners with pre-incarceration heroin addiction . METHODS A three-group r and omized controlled trial was conducted between September 2003 and June 2005 . Two hundred eleven Baltimore pre-release inmates who were heroin dependent during the year prior to incarceration were enrolled in this study . Participants were r and omly assigned to the following : counseling only : counseling in prison , with passive referral to treatment upon release ( n=70 ) ; counseling+transfer : counseling in prison with transfer to methadone maintenance treatment upon release ( n=70 ) ; and counseling+methadone : methadone maintenance and counseling in prison , continued in a community-based methadone maintenance program upon release ( n=71 ) . RESULTS Two hundred participants were located for follow-up interviews and included in the current analysis . The percentages of participants in each condition that entered community-based treatment were , respectively , counseling only 7.8 % , counseling+transfer 50.0 % , and counseling+methadone 68.6 % , p<.05 . All pairwise comparisons were statistically significant ( all ps<.05 ) . The percentage of participants in each condition that tested positive for opioids at 1-month post-release were , respectively , counseling only 62.9 % , counseling+transfer 41.0 % , and counseling+methadone 27.6 % , p<.05 , with the counseling only group significantly more likely to test positive than the counseling+methadone group . CONCLUSIONS Methadone maintenance initiated prior to or immediately after release from prison appears to have beneficial short-term impact on community treatment entry and heroin use . This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories Background Approximately 10 million Americans enter jails annually . The Centers for Disease Control and Prevention now recommends routine opt-out HIV testing in these setting s. The logistics for performing routine opt-out HIV testing within jails , however , remain controversial . The objective of this study was to evaluate the optimal time to routinely HIV test newly incarcerated jail detainees using an opt-out strategy . Methods This prospect i ve , controlled trial of routine opt-out HIV testing was conducted among 298 newly incarcerated male inmates in an urban men 's jail in New Haven , Connecticut . 298 sequential entrants to the men 's jail over a three week period in March and April 2008 were assigned to be offered routine opt-out HIV testing at one of three points after incarceration : immediate ( same day , n = 103 ) , early ( next day , n = 98 ) , or delayed ( 7 days , n = 97 ) . The primary outcome was the proportion of men in each group consenting to testing . Results Routine opt-out HIV testing was significantly higher for the early ( 53 % : AOR = 2.6 ; 95 % CI = 1.5 to 4.7 ) and immediate ( 45 % : AOR = 2.3 ; 95 % CI = 1.3 to 4.0 ) testing groups compared to the delayed ( 33 % ) testing group . The immediate and early testing groups , however , did not significantly differ ( p = 0.67 ) . In multivariate analyses , factors significantly associated with routine opt-out HIV testing were assignment to the ‘ early ’ testing group ( p = 0.0003 ) and low ( bond ≥$5,000 , immigration or federal charges or pre-sentencing > 30 days ) likelihood of early release ( p = 0.04 ) . Two subjects received preliminary positive results and one of them was subsequently confirmed HIV seropositive . Conclusions In this men 's jail where attrition was high , routine opt-out HIV testing was not only feasible , but result ed in the highest rates of HIV testing when performed within 24 hours of incarceration . Trial Registration Clinical Trials.gov Background Ten million Americans enter jails annually . The objective was to evaluate new CDC guidelines for routine opt-out HIV testing and examine the optimal time to implement routine opt-out HIV testing among newly incarcerated jail detainees . Methods This prospect i ve , controlled trial of routine opt-out HIV testing was conducted among 323 newly incarcerated female inmates in Connecticut 's only women 's jail . 323 sequential entrants to the women 's jail over a five week period in August and September 2007 were assigned to be offered routine opt-out HIV testing at one of three points after incarceration : immediate ( same day , n = 108 ) , early ( next day , n = 108 ) , or delayed ( 7 days , n = 107 ) . The primary outcome was the proportion of women in each group consenting to testing . Results Routine opt-out HIV testing was significantly highest ( 73 % ) among the early testing group compared to 55 % for immediate and 50 % for 7 days post-entry groups . Other factors significantly ( p = 0.01 ) associated with being HIV tested were younger age and low likelihood of early release from jail based on bond value or type of charge for which women were arrested . Conclusions In this correctional facility , routine opt-out HIV testing in a jail setting was feasible , with highest rates of testing if performed the day after incarceration . Lower testing rates were seen with immediate testing , where there is a high prevalence of inability or unwillingness to test , and with delayed testing , where attrition from jail increases with each passing day . Trial Registration Clinical Trials.gov BACKGROUND We aim ed to assess audio-computer-assisted self-interviewing ( audio-CASI ) as a method of reducing under-reporting of HIV risk behaviour among injecting drug users . METHODS Injecting drug users were interviewed at syringe-exchange programmes in four US cities . Potential respondents were r and omly selected from participants in the syringe exchanges , with weekly alternate assignment to either traditional face-to-face interviews or audio-CASI . The question naire included items on sociodemographic characteristics , drug use , and HIV risk behaviours for 30 days preceding the interview . We calculated odds ratios for the difference in reporting of HIV risk behaviours between interview methods . FINDINGS 757 respondents were interviewed face-to-face , and 724 were interviewed by audio-CASI . More respondents reported HIV risk behaviours and other sensitive behaviours in audio-CASI than in face-to-face interviews ( odds ratios for reporting of rented or bought used injection equipment in audio-CASI vs face-to-face interview 2.1 [ 95 % CI 1.4 - 3.3 ] p=0.001 ; for injection with borrowed used injection equipment 1.5 [ 1.1 - 2.2 ] p=0.02 ; for renting or selling used equipment 2.3 [ 1.3 - 4.0 ] p=0.003 ) . INTERPRETATION Although validation of these self-reported behaviours was not possible , we propose that audio-CASI enables substantially more complete reporting of HIV risk behaviour . More complete reporting might increase underst and ing of the dynamics of HIV transmission and make the assessment of HIV-prevention efforts easier BACKGROUND Antiretroviral pre-exposure prophylaxis reduces sexual transmission of HIV . We assessed whether daily oral use of tenofovir disoproxil fumarate ( tenofovir ) , an antiretroviral , can reduce HIV transmission in injecting drug users . METHODS In this r and omised , double-blind , placebo-controlled trial , we enrolled volunteers from 17 drug-treatment clinics in Bangkok , Thail and . Participants were eligible if they were aged 20 - 60 years , were HIV-negative , and reported injecting drugs during the previous year . We r and omly assigned participants ( 1:1 ; blocks of four ) to either tenofovir or placebo using a computer-generated r and omisation sequence . Participants chose either daily directly observed treatment or monthly visits and could switch at monthly visits . Participants received monthly HIV testing and individualised risk-reduction and adherence counselling , blood safety assessment s every 3 months , and were offered condoms and methadone treatment . The primary efficacy endpoint was HIV infection , analysed by modified intention-to-treat analysis . This trial is registered with Clinical Trials.gov , number NCT00119106 . FINDINGS Between June 9 , 2005 , and July 22 , 2010 , we enrolled 2413 participants , assigning 1204 to tenofovir and 1209 to placebo . Two participants had HIV at enrolment and 50 became infected during follow-up : 17 in the tenofovir group ( an incidence of 0·35 per 100 person-years ) and 33 in the placebo group ( 0·68 per 100 person-years ) , indicating a 48·9 % reduction in HIV incidence ( 95 % CI 9·6 - 72·2 ; p=0·01 ) . The occurrence of serious adverse events was much the same between the two groups ( p=0·35 ) . Nausea was more common in participants in the tenofovir group than in the placebo group ( p=0·002 ) . INTERPRETATION In this study , daily oral tenofovir reduced the risk of HIV infection in people who inject drugs . Pre-exposure prophylaxis with tenofovir can now be considered for use as part of an HIV prevention package for people who inject drugs . FUNDING US Centers for Disease Control and Prevention and the Bangkok Metropolitan Administration AIMS To examine the long-term impact of methadone maintenance treatment ( MMT ) on mortality , re-incarceration and hepatitis C seroconversion in imprisoned male heroin users . DESIGN , SETTING AND PARTICIPANTS The study cohort comprised 382 imprisoned male heroin users who had participated in a r and omized controlled trial of prison-based MMT in 1997/98 . Subjects were followed-up between 1998 and 2002 either in the general community or in prison . MEASUREMENTS All-cause mortality , re-incarceration , hepatitis C and HIV serostatus and MMT retention . FINDINGS There were no deaths recorded while subjects were enrolled in MMT . Seventeen subjects died while out of MMT , representing an untreated mortality rate of 2.0 per 100 person-years ( 95 % CI , 1.2 - 3.2 ) . Re-incarceration risk was lowest during MMT episodes of 8 months or longer ( adjusted hazard ratio 0.3 ( 95 % CI , 0.2 - 0.5 ; P < 0.001 ) , although MMT periods 2 months or less were associated with greatest risk of re-incarceration ( P < 0.001 ) . Increased risk of hepatitis C seroconversion was significantly associated with prison sentences of less than 2 months [ adjusted hazard ratio 20 ( 95 % CI , 5 - 76 ; < P = 0.001 ) ] and MMT episodes less than 5 months [ adjusted hazard ratio 4.2 ( 95 % CI , 1.4 - 12.6 ; P = 0.01 ) ] . Subjects were at greatest risk of MMT dropout during short prison sentences of 1 month or less ( adjusted hazard ratio 10.4 ( 95 % CI , 7.0 - 15.7 ; P < 0.001 ) . HIV incidence was 0.3 per 100 person-years ( 95 % CI , 0.03 - 0.99 ) . CONCLUSIONS Retention in MMT was associated with reduced mortality , re-incarceration rates and hepatitis C infection . Prison-based MMT programmes are integral to the continuity of treatment needed to ensure optimal outcomes for individual and public health This study examined benefits of methadone maintenance among prerelease prison inmates . Incarcerated males with preincarceration heroin dependence ( n = 197 ) were r and omly assigned to ( a ) group educational counseling ( counseling only ) ; ( b ) counseling , with opportunity to begin methadone maintenance on release ( counseling + transfer ) ; or ( c ) counseling and methadone maintenance in prison , with opportunity to continue methadone maintenance on release ( counseling + methadone ) . At 90-day follow-up , counseling + methadone participants were significantly more likely than counseling-only and counseling + transfer participants to attend drug treatment ( p = .0001 ) and less likely to be reincarcerated ( p = .019 ) . Counseling + methadone and counseling + transfer participants were significantly less likely ( all ps < .05 ) to report heroin use , cocaine use , and criminal involvement than counseling-only participants . Follow-up is needed to determine whether these findings hold over a longer period AIMS Recent studies have demonstrated the efficacy of both methadone and buprenorphine when used with opioid dependent men transitioning from prison to the community , but no studies have been conducted with women in the criminal justice ( CJ ) system . The aim of this study was to determine the efficacy of buprenorphine for relapse prevention among opioid dependent women in the CJ system transitioning back to the community . METHODS 36 women under CJ supervision were recruited from an inpatient drug treatment facility that treats CJ individuals returning back to the community . Nine were enrolled in an open label buprenorphine arm then
Output:
| Numerous interventions may reduce HIV-related risks among adults with criminal justice involvement . |
MS213142 | ***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 Objective : To assess three prescribing strategies for sore throat . Design : R and omised follow up study . Setting : 11 general practice s in the South and West region . Subjects : 716 patients aged 4 years and over with sore throat and an abnormal physical sign in the throat ; 84 % had tonsillitis or pharyngitis . Patients were r and omised to three groups : prescription for antibiotics for 10 days ( group 1 , 246 patients ) ; no prescription ( group 2 , 230 patients ) ; or prescription for antibiotics if symptoms were not starting to settle after three days ( group 3 ; 238 patients ) . Main outcome measures : Duration of symptoms ; satisfaction and compliance with and perceived efficacy of antibiotics ; time off school or work . Outcomes were documented in 582 subjects ( 81 % ) . Results : Median duration of antibiotic use differed significantly in the three groups ( 10 v 0 v 0 days , P<0.001 ) ; 69 % of patients in group 3 did not use their prescription . The proportion of patients better by day 3 did not differ significantly ( 37 % v 35 % v 30 % , P=0.28 ) , nor did the duration of illness ( median 4 v 5 v 5 days , P=0.39 ) , days off work or school ( median 2 v 2 v 1 , P=0.13 ) , or proportion of patients satisfied ( 96 % v 90 % v 93 % , P=0.09 ) , although group 1 had fewer days of fever ( median 1 v 2 v 2 days , P=0.04 ) . More patients in group 1 thought the antibiotics were effective ( 87 % v 55 % v 60 % , P<0.001 ) and intended coming to the doctor in future attacks ( 79 % v 54 % v 57 % , P<0.001 ) . “ Legitimation ” of illness — to explain to work or school ( 60 % ) or family or friends (37%)–was an important reason for consultation . Patients who were more satisfied got better more quickly , and satisfaction related strongly to how well the doctor dealt with patient 's concerns . Conclusion : Prescribing antibiotics for sore throat only marginally affects the resolution of symptoms but enhances belief in antibiotics and intention to consult in future when compared with the acceptable strategies of no prescription or delayed prescription . Psychosocial factors are important in the decision to see a general practitioner and in predicting the duration of illness . Key messages Sore throat is one of the commonest presentations of upper respiratory illness to general practitioners , and attendance is increasing Prescribing antibiotics for sore throat does not reduce the extent and duration of symptoms Prescribing antibiotics enhances belief in antibiotics and intention to consult Legitimation of illness is an important reason for attending the doctor Satisfaction predicts duration of illness and closely relates to how well concerns are dealt with — unless patients are very ill , general practitioners should consider exploring concerns and should avoid or delay prescribing OBJECTIVE To vali date a score based on clinical symptoms and signs for the identification of group A Streptococcus ( GAS ) infection in general practice patients with score throat . DESIGN A single throat swab was used as the gold st and ard for diagnosing GAS infection . Clinical information was recorded by experienced family physicians on st and ardized encounter forms . Score criteria were identified by means of logistic regression modelling of data from patients enrolled in the first half of the study . The score was then vali date d among the remaining patients . SETTING University-affiliated family medicine centre in Toronto . PATIENTS A total of 521 patients aged 3 to 76 years presenting with a new upper respiratory tract infection from December 1995 to February 1997 . OUTCOME MEASURES Sensitivity , specificity and likelihood ratios for identification of GAS infection with the score approach compared with throat culture . Proportion of patients prescribed antibiotics , throat culture use , and sensitivity and specificity with usual physician care and with score-based recommendations were compared . RESULTS A score was developed ranging in value from 0 to 4 . The sensitivity of the score for identifying GAS infection was 83.1 % , compared with 69.4 % for usual physician care ( p = 0.06 ) ; the specificity values of the 2 approaches were similar . Among patients aged 3 to 14 years , the sensitivity of the score approach was higher than that of usual physician care ( 96.9 % v. 70.6 % ) ( p < 0.05 ) . The proportion of patients receiving initial antibiotic prescriptions would have been reduced 48 % by following score-based recommendations compared with observed physician prescribing ( p < 0.001 ) , without any increase in throat culture use . CONCLUSIONS An age-appropriate sore throat score identified GAS infection in children and adults with sore throat better than usual care by family physicians , with significant reductions in unnecessary prescribing of antibiotics . A r and omized trial comparing the 2 approaches is recommended to determine the ability of the score approach to reduce unnecessary prescribing of antibiotics during routine clinical encounters The data for medical decision analyses are often unreliable . Traditional sensitivity analysis --varying one or more probability or utility estimates from baseline values to see if the optimal strategy changes -- is cumbersome if more than two values are allowed to vary concurrently . This paper describes a practical method for probabilistic sensitivity analysis , in which uncertainties in all values are considered simultaneously . The uncertainty in each probability and utility is assumed to possess a probability distribution . For ease of application we have used a parametric model that permits each distribution to be specified by two values : the baseline estimate and a bound ( upper or lower ) of the 95 percent confidence interval . Following multiple simulations of the decision tree in which each probability and utility is r and omly assigned a value within its distribution , the following results are recorded : ( a ) the mean and st and ard deviation of the expected utility of each strategy ; ( b ) the frequency with which each strategy is optimal ; ( c ) the frequency with which each strategy " buys " or " costs " a specified amount of utility relative to the remaining strategies . As illustrated by an application to a previously published decision analysis , this technique is easy to use and can be a valuable addition to the armamentarium of the decision analyst BACKGROUND Primary prevention of acute rheumatic fever requires antibiotic treatment of acute streptococcal pharyngitis . In developing countries , clinicians must rely on clinical guidelines for presumptive treatment of streptococcal pharyngitis since bacterial culture and rapid diagnostic tests are not feasible . We evaluated the WHO Acute Respiratory Infection guideline in a large urban paediatric clinic in Egypt . METHODS Children between 2 and 13 years of age who had a sore throat and pharyngeal erythema were enrolled in the study . Clinical , historical , and demographic information was recorded and a throat culture for group A beta-haemolytic streptococci was done . Sensitivity ( % of true-positive throat cultures ) and specificity ( % of true-negative throat cultures ) were calculated for each clinical feature . The effect of various guidelines on correct presumptive treatment for throat-culture status was calculated . FINDINGS Of 451 children with pharyngitis , 107 ( 24 % ) had group A beta-haemolytic streptococci on throat culture . A purulent exu date was seen in 22 % ( 99/450 ) of these children and this sign was 31 % sensitive and 81 % specific for a positive culture . The WHO Acute Respiratory Infections ( ARI ) guidelines , which suggest treatment for pharyngeal exu date plus enlarged and tender cervical node , were 12 % sensitive and 94 % specific ; 13/107 children with a positive throat culture would correctly receive antibiotics and 323/344 with a negative throat culture would , correctly , not receive antibiotics . Based on our data we propose a modified guideline whereby exu date or large cervical nodes would indicate antibiotic treatment , and this guideline would be 84 % sensitive and 40 % specific ; 90/107 children with a positive throat culture would correctly receive antibiotics and 138/344 with a negative throat culture would , correctly , not receive antibiotics . INTERPRETATION The WHO ARI clinical guideline has a high specificity but low sensitivity that limits the unnecessary use of antibiotics , but does not treat 88 % of children with a positive streptococcal throat culture who are at risk of acute rheumatic fever . A modified guideline may be more useful in this population . Prospect i ve studies of treatment guidelines from many regions are needed to assess their use since the frequency of pharyngitis varies BACKGROUND Sore throat is very common in general practice and is usually caused by viral infection . Nevertheless , up to 95 % of patients may be treated with antibiotics . Previous diagnostic systems have not transferred well from one area to another because of an inability to allow for changing prevalence of streptococcus . AIM To measure the occurrence rates of symptoms and signs in sore throat patients with and without streptococcal infection , and to develop a Bayesian scoring system which is easily adapted for prevalence to predict if patients have bacterial infection . METHOD Occurrence rates of symptoms and signs were measured for 206 patients with sore throat symptoms over a 3-year period . Bayesian probability scores ( B-scores ) for each data item were calculated from the ocurrence rates in the patients with positive throat cultures for group A streptococci and the rates in patients with negative throat cultures . The B-score values were then used to predict the probability of positive culture for each patient . RESULTS The streptococcal throat B-score system predicted positive culture with a sensitivity of 71 % and a specificity of 71 % . In comparison , the unaided general practitioners predicted infection with a sensitivity of 61 % and a specificity of 65 % . If the B-score prediction had been used to decide on treatment , more patients with streptococci present on culture would have been treated with antibiotic ( 71 % instead of 68 % ) and appreciably fewer patients with negative streptococcal cultures would have been treated ( 29 % instead of 59 % ) . CONCLUSION Use of the B-score system could result in significant savings in unnecessary antibiotic prescription , and unnecessary throat swab cultures , while achieving better levels of treatment Abstract Objective : To assess whether treatment with penicillin for three days and the traditional treatment for seven days were equally as effective at accelerating resolution of symptoms in patients with sore throat compared with placebo . Design : R and omised double blind placebo controlled trial . Setting : 43 family practice s in the Netherl and s. Participants : 561 patients , aged 15 - 60 years , with sore throat for less than seven days and at least three of the four Centor criteria —that is , history of fever , absence of cough , swollen tender anterior cervical lymph nodes , and tonsillar exu date . 142 patients were excluded for medical reasons and 73 needed penicillin . Interventions : Patients were r and omly assigned to penicillin V for seven days , penicillin V for three days followed by placebo for four days , or placebo for seven days . Main outcome measures : Resolution of symptoms in the first week , eradication of bacteria after two weeks , and recurrences of sore throat after two , four , and six months . Results : Symptoms resolved 1.9 and 1.7 days earlier in patients taking penicillin for seven days than in those taking penicillin for three days or placebo respectively . Symptoms resolved 2.5 days earlier in patients with group A streptococci and 1.3 days earlier in patients with high colony counts of non-group A streptococci . 23 ( 13 % ) of the placebo group had to be given antibiotics later in the week because of clinical deterioration ; three developed a peritonsillar abscess . The eradication rate for group A streptococci was 72 % in the seven day penicillin group , 41 % in the three day penicillin group , and 7 % in the placebo group . Sore throat recurred more often in the three day penicillin group than in the seven day penicillin or placebo groups . Conclusion : Penicillin treatment for seven days was superior to treatment for three days or placebo in resolving symptoms of sore throat in patients with group A streptococcal pharyngitis and , possibly , in those with non-group A streptococcal pharyngitis The usefulness of clinical and laboratory findings for prediction of the presence of Group A streptococci on throat culture and of an increase in antistreptococcal antibodies was investigated in 693 adult patients . Several findings were shown to increase the likelihood of streptococcal isolation , alone and in combination : tonsillar exu date , tonsillar enlargement , tender anterior cervical adenopathy , myalgias , and a positive throat culture in the preceding year . Compared with a frequency of 9.7 % in all patients , the probabilities of a positive culture were quite different ( ranging from 2 to 53 % ) in subgroups of patients with different combinations of these clinical findings . The results of a leukocyte count and measurement of C-reactive protein added little additional predictive information . While clinical findings can never predict perfectly the results of a throat culture , they nevertheless can provide useful information — particularly in tending to “ rule out ” streptococcal infection — in adult patients with pharyngitis An optical immunoassay ( OIA ) has been reported to be more sensitive than conventional culture for the detection of Group A Streptococcus , eliminating the need for culture . We attempted to confirm the sensitivity and specificity through a labor
Output:
| Little evidence suggests that treatment prevents glomerulonephritis ( 18 - 20 ) . |
MS213143 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND AND OBJECTIVE To conduct a pilot study to compare the frequency of errors that accompany single vs. double data extraction , compare the estimate of treatment effect derived from these methods , and compare the time requirements for these methods . METHODS Review ers were r and omized to the role of data extractor or data verifier , and were blind to the study hypothesis . The frequency of errors associated with each method of data extraction was compared using the McNemar test . The data set for each method was used to calculate an efficacy estimate by each method , using st and ard meta-analytic techniques . The time requirement for each method was compared using a paired t-test . RESULTS Single data extraction result ed in more errors than double data extraction ( relative difference : 21.7 % , P = .019 ) . There was no substantial difference between methods in effect estimates for most outcomes . The average time spent for single data extraction was less than the average time for double data extraction ( relative difference : 36.1 % , P = .003 ) . CONCLUSION In the case that single data extraction is used in systematic review s , review ers and readers need to be mindful of the possibility for more errors and the potential impact these errors may have on effect estimates Background Quality indicator collection and feedback improves stroke care . We sought to determine whether quality improvement training plus indicator feedback was more effective than indicator feedback alone in improving inpatient stroke indicators . Methods We conducted a cluster-r and omised quality improvement trial , r and omising hospitals to quality improvement training plus indicator feedback versus indicator feedback alone to improve deep vein thrombosis ( DVT ) prophylaxis and dysphagia screening . Intervention sites received collaborative-based quality improvement training , external facilitation and indicator feedback . Control sites received only indicator feedback . We compared indicators pre-implementation ( pre-I ) to active implementation ( active-I ) and post-implementation ( post-I ) periods . We constructed mixed-effect logistic models of the two indicators with a r and om intercept for hospital effect , adjusting for patient , time , intervention and hospital variables . Results Patients at intervention sites ( 1147 admissions ) , had similar race , gender and National Institutes of Health Stroke Scale scores to control sites ( 1017 admissions ) . DVT prophylaxis improved more in intervention sites during active-I period ( ratio of ORs 4.90 , p<0.001 ) , but did not differ in post-I period . Dysphagia screening improved similarly in both groups during active-I , but control sites improved more in post-I period ( ratio of ORs 0.67 , p=0.04 ) . In logistic models , the intervention was independently positively associated with DVT performance during active-I period , and negatively associated with dysphagia performance post-I period . Conclusion Quality improvement training was associated with early DVT improvement , but the effect was not sustained over time and was not seen with dysphagia screening . External quality improvement programmes may quickly boost performance but their effect may vary by indicator and may not sustain over time
Output:
| Although similarities were found , no approaches contained the same combination of the constructs nor did any single approach capture all identified constructs .
From these results , a consoli date d framework for sustainability constructs in healthcare was developed .
Conclusions Choosing a sustainability method can pose a challenge because of the diverse approaches reported in the literature . |
MS213144 | ***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: Thirty subjects were exposed to low frequency sinusoidal and r and om whole body vibration in the vertical direction , 0.3 m/sec2 ( rms ) . Changes in wakefulness during 15 min vibration were compared to changes occurring during corresponding pauses without exposure . Measurements were made on EEG and ECG . Exposure to whole body vibration was found to be correlated with reduction in wakefulness . This effect , verified by an increase of theta and decrease of alpha activity , was greater during sinusoidal than r and om vibration Objective This investigation was to assess the effect of different vibration frequencies on heart rate variability ( HRV ) and driving fatigue in healthy subjects during simulated driving , by the use of power spectrum analysis and subjective evaluation . Material s and methods Sixty healthy subjects ( 29.6±3.3 years ) were r and omly divided into three groups , A , B and C , and the subjects of each group participated in the simulated driving for 90 min with vertical sinusoidal vibration ( acceleration 0.05 g ) of 1.8 Hz ( group A ) , 6 Hz ( group B ) and no vibration ( group C ) , respectively . Low-frequency ( LF ) and high-frequency ( HF ) components of HRV , reflecting sympathetic and parasympathetic activities , and the LF : HF ratio , indicating sympathovagal balance , were measured throughout all periods . All indices of HRV were calculated in the pre-experiment period , mid-experiment period and end-experiment period , and were analyzed by repeated measures analysis of variance . Subjective responses to a question naire were obtained after the simulated task for the three groups . Results Significant differences in all indices of HRV were observed between different experiment periods and between any two groups . The ratings of subjective fatigue exhibited significant differences between any two groups . Conclusion The drivers ’ fatigue ratings were associated with vibration frequencies in simulated driving . The study quantitatively demonstrated that different effects on autonomic nerve activities were induced by different vibration frequencies We investigated the impact of mental fatigue on exploration in a complex computer task . The exploration behavior of participants who underwent a fatigue manipulation ( N = 36 ) was compared with that of a control ( nonfatigued ) group ( N = 32 ) . A distinction was also made between participants with high or low levels of general computer experience . Results showed that fatigued participants used significantly less systematic exploration and made more errors than did nonfatigued participants . Fatigued participants with low computer experience also showed significantly more rigid behavior than did the other participants . No differences were found on the number of subtasks solved . Compared with low-experience participants , highly experienced participants showed significantly more systematic exploration , less un systematic trial and error , solved more subtasks , and made fewer errors ( marginally significant p = .056 ) . Findings were interpreted as the result of reduced task engagement under fatigue and reduced involvement of executive control on behavior . Actual or potential applications of this research include guidelines to prevent detrimental effects of mental fatigue on exploration behavior OBJECTIVES Disability retirement may increase as the work force ages , but there is little information on factors associated with retirement because of disability . This is the first prospect i ve population -based study of predictors of disability retirement including information on workplace , socioeconomic , behavioral , and health-related factors . METHODS The subjects were 1038 Finnish men who were enrolled in the Kuopio Ischemic Heart Disease Risk Factor Study , who were 42 , 48 , 54 , or 60 years of age at the beginning of the study , and who participated in a 4-year follow-up medical examination . RESULTS Various job characteristics predicted disability retirement . Heavy work , work in uncomfortable positions , long workhours , noise at work , physical job strain , musculoskeletal strain , repetitive or continuous muscle strain , mental job strain , and job dissatisfaction were all significantly associated with the incidence of disability retirement . The ability to communicate with fellow workers and social support from supervisors tended to reduce the risk of disability retirement . The relationships persisted after control for socioeconomic factors , prevalent disease , and health behavior , which were also associated with disability retirement . CONCLUSIONS The strong associations found between workplace factors and the incidence of disability retirement link the problem of disability retirement to the problem of poor work conditions This study addressed the prevalence of working overtime in relation to psychosocial work characteristics and need for recovery . More precisely , the aim of this study was to find out ( 1 ) whether a relationship exists between working overtime and psychosocial work characteristics ( job dem and s and job control ) , ( 2a ) whether a relationship exists between working overtime and need for recovery , and finally ( 2b ) whether such a relationship depends on job type ( a specific combination of job dem and s and job control ) . The study sample ( N=1,473 ) consisted of a national r and om sample of office-based municipal administration employees who worked full-time . These employees completed a question naire on working conditions , overtime and need for recovery , among other things . Overtime was especially common in jobs characterised by high dem and s. The analyses showed that working overtime is not associated with a higher need for recovery in the total study population . However , there was a positive relationship between overtime hours and need for recovery in high strain jobs ( high dem and s , low control ) . Furthermore , there was a positive relationship between structural overtime and need for recovery in active jobs ( high dem and s , high control ) . The relationship between overtime and need for recovery seems to be dependent upon working conditions ; indicators of overtime were associated with a higher need for recovery only for employees who experienced high job dem and s. Longitudinal research within a heterogeneous sample will be necessary to draw firm conclusions about causality with respect to the relationship between overtime , need for recovery and working conditions Study objective : To examine whether the effects of work stress on sickness absence vary by the level of control the employees have over their working times . Design : Prospect i ve cohort study . A survey of job strain , effort-reward imbalance , and control over daily working hours and days off was carried out in 2000–01 . The survey responses were linked with registered data on the number of medically certified ( > 3 days ) sickness absences from one year before the survey until the end of 2003 . The mean follow up period was 28.2 ( SD 8.1 ) months . Adjustments were made for demographics and behavioural health risks . Aggregated measures of worktime control according to workplaces were used to control for differences in reactivity and response style . Setting : Ten towns in Finl and . Participants : 16 139 public sector employees who had no medically certified sickness absences in the year preceding the survey . Main results : Among the women , individually measured control over daily working hours and days off moderated the association between work stress and sickness absence . The combination of high stress and good worktime control was associated with lower absence rates than a combination of high stress and poor worktime control . This finding was replicated in the analyses using workplace aggregates of worktime control . Among the men , the findings were less consistent and not replicable using aggregated measures of worktime control . Conclusions : Good control over working times reduces the adverse effect of work stress on sickness absence especially among female employees We investigated whether fatigue during prolonged exercise in uncompensable hot environments occurred at the same critical level of hyperthermia when the initial value and the rate of increase in body temperature are altered . To examine the effect of initial body temperature [ esophageal temperature ( Tes ) = 35.9 + /- 0.2 , 37.4 + /- 0 . 1 , or 38.2 + /- 0.1 ( SE ) degrees C induced by 30 min of water immersion ] , seven cyclists ( maximal O2 uptake = 5.1 + /- 0.1 l/min ) performed three r and omly assigned bouts of cycle ergometer exercise ( 60 % maximal O2 uptake ) in the heat ( 40 degrees C ) until volitional exhaustion . To determine the influence of rate of heat storage ( 0.10 vs. 0.05 degrees C/min induced by a water-perfused jacket ) , four cyclists performed two additional exercise bouts , starting with Tes of 37.0 degrees C. Despite different initial temperatures , all subjects fatigued at an identical level of hyperthermia ( Tes = 40 . 1 - 40.2 degrees C , muscle temperature = 40.7 - 40.9 degrees C , skin temperature = 37.0 - 37.2 degrees C ) and cardiovascular strain ( heart rate = 196 - 198 beats/min , cardiac output = 19.9 - 20.8 l/min ) . Time to exhaustion was inversely related to the initial body temperature : 63 + /- 3 , 46 + /- 3 , and 28 + /- 2 min with initial Tes of approximately 36 , 37 , and 38 degrees C , respectively ( all P < 0.05 ) . Similarly , with different rates of heat storage , all subjects reached exhaustion at similar Tes and muscle temperature ( 40.1 - 40.3 and 40 . 7 - 40.9 degrees C , respectively ) , but with significantly different skin temperature ( 38.4 + /- 0.4 vs. 35.6 + /- 0.2 degrees C during high vs. low rate of heat storage , respectively , P < 0.05 ) . Time to exhaustion was significantly shorter at the high than at the lower rate of heat storage ( 31 + /- 4 vs. 56 + /- 11 min , respectively , P < 0.05 ) . Increases in heart rate and reductions in stroke volume paralleled the rise in core temperature ( 36 - 40 degrees C ) , with skin blood flow plateauing at Tes of approximately 38 degrees C. These results demonstrate that high internal body temperature per se causes fatigue in trained subjects during prolonged exercise in uncompensable hot environments . Furthermore , time to exhaustion in hot environments is inversely related to the initial temperature and directly related to the rate of heat storage Daytime performance changes were examined during chronic sleep restriction or augmentation and following subsequent recovery sleep . Sixty-six normal volunteers spent either 3 ( n = 18 ) , 5 ( n= 16 ) , 7 ( n = 16 ) , or 9 h ( n = 16 ) daily time in bed ( TIB ) for 7 days ( restriction/augmentation ) followed by 3 days with 8 h daily TIB ( recovery ) . In the 3-h group , speed ( mean and fastest 10 % of responses ) on the psychomotor vigilance task ( PVT ) declined , and PVT lapses ( reaction times greater than 500 ms ) increased steadily across the 7 days of sleep restriction . In the 7- and 5-h groups speed initially declined , then appeared to stabilize at a reduced level ; lapses were increased only in the 5-h group . In the 9-h group , speed and lapses remained at baseline levels . During recovery , PVT speed in the 7- and 5-h groups ( and lapses in the 5-h group ) remained at the stable , but reduced levels seen during the last days of the experimental phase , with no evidence of recovery . Speed and lapses in the 3-h group recovered rapidly following the first night of recovery sleep ; however , recovery was incomplete with speed and lapses stabilizing at a level comparable with the 7- and 5-h groups . Performance in the 9-h group remained at baseline levels during the recovery phase . These results suggest that the brain adapts to chronic sleep restriction . In mild to moderate sleep restriction this adaptation is sufficient to stabilize performance , although at a reduced level . These adaptive changes are hypothesized to restrict brain operational capacity and to persist for several days after normal sleep duration is restored , delaying recovery The effects of mental fatigue on planning and preparation for future actions were examined , using a task switching paradigm . Fatigue was induced by " time on task , " with subjects performing a switch task continuously for 2 hr . Subjects had to alternate between tasks on every second trial , so that a new task set was required on every second trial . Manipulations of response-stimulus intervals ( RSIs ) were used to examine whether subjects prepared themselves for the task change . Behavioral measurements , event-related potentials ( ERPs ) , and mood question naires were used to assess the effects of mental fatigue . Reaction times ( RTs ) were faster on trials in which no change in task set was required in comparison with switch trials , requiring a new task set . Long RSIs were used efficiently to prepare for the processing of subsequent stimuli . With increasing mental fatigue , preparation processes seemed to become less adequate and the number of errors increased . A clear poststimulus parietal negativity was observed on repetition trials , which reduced with time on task . This attention-related component was less pronounced in switch trials ; instead , ERPs elicited in switch trials showed a clear frontal negativity . This negativity was also diminished by time on task . ERP differences between repetition and switch trials became smaller with increasing time on task Abstract Objective : To examine the association between work stress , according to the job strain model and the effort-reward imbalance model , and the risk of death from cardiovascular disease . Design : Prospect i ve cohort study . Baseline examination in 1973 determined cases of cardiovascular disease , behavioural and biological risks , and stressful characteristics of work . Biological risks were measured at 5 year and 10 year follow up . Setting : Staff of a company in the metal industry in Finl and . Participants : 812 employees ( 545 men , 267 women ) who were free from cardiovascular diseases at baseline . Main outcome measure : Cardiovascular mortality 1973 - 2001 from the national mortality register . Results : Mean length of follow up was 25.6 years . After adjustment for age and sex , employees with high job strain , a combination of high dem and s at work and low job control , had a 2.2-fold ( 95 % confidence interval 1.2 to 4.2 ) cardiovascular mortality risk compared with their colleagues with low job strain . The corresponding risk ratio for employees with effort-reward imbalance ( low salary , lack of social approval , and few career opportunities relative to efforts required at work )
Output:
| RESULTS The drivers of fatigue with the greatest effect sizes include sleep deprivation and work environment factors such as noise , vibration , and temperature .
The most significant outcomes of fatigue include short-term cognitive and physical degradation and , to a lesser extent , error , injury , and illness . |
MS213145 | ***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 risk for skin cancer is increased among older males and outdoor workers who have high levels of ultraviolet ( UV ) exposure . Purpose This study was design ed to examine the long-term efficacy of UV photography interventions on male outdoor workers , the potential mediators of its impact , and the efficacy of UV photography and skin cancer vs. aging information with this population . Methods One hundred forty-eight male outdoor workers were r and omly assigned to one of four intervention conditions or a control condition in a two by two plus one factorial design . The men in the intervention conditions received or did not receive a UV photo of their face and watched either a photoaging or skin cancer educational video . Participants completed pre-intervention , immediate post-intervention , and 2-month and 1-year follow-up assessment s. Results Analysis of covariance and structural equation modeling revealed that participants in the UV photography and cancer information interventions reported higher levels of sun protection cognitions , which were significant partial mediators of increases in sun protection behaviors and decreases in skin color . Conclusions This study provides evidence for effective sun protection interventions on male outdoor workers that may help reduce skin cancer risk OBJECTIVES We examined whether US Postal Service letter carriers who received a sun safety intervention would wear wide-brim hats and sunscreen significantly more often than those who did not receive the intervention . METHODS We used a 2-group r and omized design with 2662 evaluation cohort participants from 70 US postal stations . Evaluations were conducted at baseline , 3 months , 1 year , and 2 years . Question naire items assessed occupational use of sun-screen and wide-brim hats . The 2-year sun safety intervention included the provision of wide-brim hats , accessible sunscreen , reminders , and 6 educational sessions . RESULTS At the 3-month follow-up evaluations , the odds ratio ( OR ) for regular sun-screen use was 2.8 times higher among the intervention group than among the control group ( 95 % confidence interval [CI]=2.2 , 3.5 ) ; at the 2-year follow-up evaluations , the rate was still significantly higher ( OR=2.0 ; 95 % CI=1.6 , 2.6 ) . Intervention group participants also had significantly higher rates of hat use , with the differences remaining consistent across all follow-ups ( OR=2.9 ; 95 % CI=2.3 , 3.6 ) . CONCLUSIONS The intervention should be disseminated to postal stations nationwide and possibly to other occupational groups that work outdoors BACKGROUND Aquatic staff , including lifeguards , are exposed to intense sunlight for many hours each day and are likely to be at a relatively high risk for developing skin cancer . However , no interventions have been specifically directed to staff at outdoor swimming pool sites . METHODS We conducted a r and omized controlled trial among aquatic staff at 28 outdoor pool sites in Hawaii and Massachusetts . Intervention pools received sun protection education and control pools received education on child injury prevention . Staff in both arms received orientation sessions and led instruction during swim lessons . Analysis of covariance was used to compare and test for changes in outcome variables ( sun protection habits and sunburning rates of aquatic staff ) and pool protection policies . Surveys were completed at the beginning and end of the summer . RESULTS Surveys were completed by 220 aquatics staff at baseline ; 194 surveys were completed at posttest . Compared with staff at control pools , sun protection policies ( P < 0.04 ) and sunburning rates ( P < 0.05 ) improved at sun protection pools from baseline to posttest . However , the difference in the mean score of all sun protection habits between the two study groups was nonsignificant . CONCLUSION The Pool Cool sun protection intervention had significant effects on lifeguards ' sunburn rates and pool sun safety policies but did not improve reported sun protection behaviors . More intensive strategies may be needed to influence aquatics workers who have already begun to adopt skin cancer prevention practice ABSTRACT A successful occupational sun-protection program was translated to 67 ski areas where the effectiveness of two dissemination strategies was assessed . An industry professional association distributed material s to the resorts . Half of the resorts received the basic dissemination strategy ( BDS ) in which the material s were simply distributed to the resorts . In a r and omized trial , the BDS was compared with an enhanced dissemination strategy ( EDS ) that added interpersonal contact with managers . Employees ( n = 2,228 ) at worksites that received the EDS had elevated program exposure ( 74.0 % at EDS vs. 57.5 % at BDS recalled a message ) . Exposure increased at two levels of program use : from less than four ( 55 % exposed ) to four to eight ( 68 % ) and to nine or more ( 82 % ) program items in use . More employees exposed to messages engaged in sun-safety behaviors than those unexposed . At worksites using nine or more items ( versus 4–8 or < 4 ) , employees engaged in additional sun-safety behaviors . Program effects were strongly mediated by increased self-efficacy . Partnerships with industry associations facilitate dissemination of evidence -based programs . Dissemination methods are needed to maximize implementation and exposure to reduce health risk behaviors Men over the age of 45 present with thicker , more advanced melanomas than younger people . A r and omised trial was conducted in this group to evaluate whether an educational brochure would increase knowledge about melanoma and the ability to recognise and discriminate between pigmented skin lesions . Men in an industrial complex were allocated to an intervention group ( n = 110 ) and two control groups ( n = 96 and n = 108 ) . The intervention group was given two educational brochures about melanoma . Their effect on knowledge and ability to detect pigmented lesions was assessed by a question naire and a self-examination body chart given before the brochure , and at four weeks and three months after return of the brochure . The control groups did not receive any educational material , but control group 2 received the question naire and chart . At the end of the study all participants were examined for pigmented lesions by doctors , whose counts were compared with those of the participants . There was a significant ( 19.8 per cent ) increase in knowledge about melanoma in the intervention group ( but not in the control groups ) , except for discrimination of photos of benign and malignant lesions . The educational material did not improve the ability of those in the intervention group to recognise and count their pigmented lesions nor to discriminate between benign and malignant pigmented lesions . The increased knowledge about melanoma was retained for at least three months OBJECTIVE To assess individual time-related ( time-stamped ) UV radiation ( UVR ) dose pattern and sun exposure behavior . DESIGN Open prospect i ve observational study . SETTING University hospital . Study Subjects Two hundred eighty-five Danish volunteers with apparently healthy skin : children , adolescents , indoor workers , sun worshippers , golfers , and gardeners ( age range , 4 - 68 years ) . Measurements We developed a personal electronic UVR dosimeter in a wristwatch ( SunSaver ) and measured continuously time-related UVR doses in st and ard erythema dose ( SED ) and corresponding sun exposure behavior from diaries , result ing in 346 sun-years ( median , 119 days ) . The estimated yearly UVR doses were calculated based on personal and ambient measured doses . RESULTS The median estimated yearly UVR dose was 173 SEDs ( range , 132 SEDs [ indoor workers]-224 SEDs [ gardeners ] ) , with no significant difference by age ( P = .25 ) or sex ( P = .75 ) . The SED of girls ( 175 SEDs ) was significantly ( P = .04 ) higher than that of boys ( 116 SEDs ) . Subjects younger than 20 years had an increase of 5 SEDs per year ( P = .03 ) . Sunbathing or exposing shoulders ( risk behavior ) outside the beach result ed in a median of 2.5 SEDs per day in northern Europe and 3.2 SEDs per day in southern Europe ; however , at the beach , corresponding values were 4.6 and 6.9 SEDs per day . Children and adolescents received more than half their total UVR dose at the beach . Sunburning doses above 10 SEDs per day were connected with sunbathing or exposing shoulders . Of the UVR dose , 50 % was received between noon and 3 PM . Only the gardeners received most of their UVR dose ( 55 % ) on working days . CONCLUSIONS High UVR doses are connected with risk behavior , except for outdoor workers . There is no need to change sun exposure habits on days without risk behavior OBJECTIVES Outdoor workers are at high risk of developing skin cancer . Primary prevention in this group can potentially reduce the incidence of skin cancer , and also potentiates the spontaneous remission of existing solar keratoses . A r and omized controlled trial was conducted to evaluate a solar protection intervention targeting outdoor workers . METHODS Outdoor workers were r and omly allocated to an intervention ( n = 65 ) or control group ( n = 77 ) . The intervention group received individual skin screening by a dermatologist and participated in an education session . Pre- and posttest outcome measures included solar protection behavior ( assessed using a vali date d diary ) , knowledge , and attitudes . RESULTS There was a significant increase ( 16 % ) in the percentage of outdoor workers who were using a high level of solar protection at posttest compared to pretest in the intervention group , but there was no change in the control group . Although both groups improved in their knowledge score , the intervention group showed a significantly greater improvement at posttest . No changes in attitudes were detected . CONCLUSIONS The findings suggest that changes in solar protection are achievable with outdoor workers Health communication campaigns intended to reduce chronic and severe exposure to ultraviolet radiation in sunlight and prevent skin cancer are a national priority . Outdoor workers represent an unaddressed , high-risk population . Go Sun Smart ( GSS ) , a worksite sun safety program largely based on the diffusion-of-innovations theory , was evaluated in a pair-matched , group-r and omized , pretest-posttest controlled design enrolling employees at 26 ski areas in Western North America . Employees at the intervention ski areas were more aware of GSS ( odds ratio [ OR ] = 8.27 , p < .05 ) and reported less sunburning ( adjusted OR = 1.63 , p < .05 ) at posttest than employees at the control areas . A dose response was evident ( OR = 1.46 , p < .05 ) with greater observed program implementation associated with fewer sunburns among employees . Program awareness per se was not predictive ( p > .05 ) of reduced sunburning in a mediational analysis . Analyses of nonrespondents , including intent-to-treat analyses , further supported the success of GSS Abstract Objectives : A grade d worksite intervention program to improve sun protection and skin cancer awareness of outdoor workers was implemented and evaluated longitudinally over a period of 20 months . Methods : Outdoor male workers ( 144/213 recruits ) from geographically separated units of the Israel National Water Company were allocated to complete ( n = 37 ) , partial ( n = 72 ) or minimal ( n = 35 ) intervention groups . Subsequent to the assignment and training of local safety officers , an educational and medical screening package was provided to the corresponding groups either once , or repeatedly a year later . Personal sun protective gear was provided upon repeated intervention . Outcome measures were evaluated through self-response question naires administered prior to the first intervention pulse , and 8 months after the first and second interventions . Results : A 15–61 % improvement in sun-protection habits was noted in the entire study population 8 months after initialization , compared to no sunscreen use , 20 % sun-exposed skin area and highest mean occupational exposure dose of 1.68 MED/day at pre-test . An even greater use of sunscreen was evident 1 year later in the complete and partial intervention groups , + 80 % and + 52 % , respectively . The baseline rate of self-examination of the skin in the same two groups ( 49 % ) increased significantly at post-test ( + 71 % and + 53 % , respectively ) . Conclusions : This integrated intervention program led to significantly improved sun protection and skin cancer awareness . Repeated intervention combined with the supply of sun-protective gear contributed to an even greater impact BACKGROUND Skin cancer is the most common form of cancer in the United States and one of the most preventable . Prevention programs for children at outdoor recreation sites may influence not only the youth , but the staff , or caregivers , as well . By teaching children about sun protection , staff may also change their sun protection behaviors . OBJECTIVE We report on the impact of a childhood skin cancer prevention program ( SunSmart ) on staff at outdoor recreation sites where a child-focused intervention was conducted . METHODS The intervention included staff training , on-site activities delivered by staff , distribution of sunscreen , and the promotion of sun-safe environments . It was hypothesized that by teaching children about sun protection , staff would change their sun protection behaviors . A r and omized trial at 14 recreation sites ( n = 176 staff ) in Hawaii tested the efficacy of education only , and education plus environmental changes , compared with a control condition . RESULTS Results showed significant positive changes in knowledge , sun protection habits , norms , and sun protection policies . The education plus environment group was not superior to education alone . CONCLUSION Changes in staff behavior and attitudes are important for their own health , as positive role models , and for the dissemination of skin cancer control programs
Output:
| Large studies with extended follow-up times demonstrated the efficacy of educational and multi-component interventions to increase sun protection , with some higher use of personal protective equipment such as sunscreen .
However , there is less evidence for the effectiveness of policy or specific intervention components . |
MS213146 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: A continuing challenge in weight loss treatment is attaining maintenance of weight loss . The goal of this study was to develop a counseling method that would assist African American breast cancer survivors with weight loss maintenance . In this pilot study , 31 obese breast cancer survivors were recruited . Individualized , dietitian-led counseling by telephone and free Weight Watchers coupons were provided to all participants for 18 months . At the 6-month time point , women were r and omized to receive spirituality counseling or not in addition to the st and ard program . The spirituality counseling was delivered via telephone using an 8-step framework . Subjects were asked to utilize daily meditation or prayer , daily readings , and the recording of thoughts in a journal . Mean weight loss from baseline to 6 months was a modest 2.0 % of baseline weight . From 6 to 18 months , there was no further weight change in the spirituality arm and a gain of 0.7 % in the dietitian-only arm . Despite little effect on weight loss , it did appear that spirituality counseling positively affected spiritual well-being ( FACIT-Sp ) scores and dietary quality . The spirituality counseling framework therefore may be further refined and useful for other health promotion studies with African American population This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS Boston University Patricia Cortes Harvard University Claudia Goldin Swarthmore College Jennifer PURPOSE Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer . The Exercise and Nutrition to Enhance Recovery and Good Health for You ( ENERGY ) study is the largest weight loss intervention trial among survivors of breast cancer to date . METHODS In this multicenter trial , 692 overweight/obese women who were , on average , 2 years since primary treatment for early-stage breast cancer were r and omly assigned to either a group-based behavioral intervention , supplemented with telephone counseling and tailored newsletters , to support weight loss or a less intensive control intervention and observed for 2 years . Weight and blood pressure were measured at 6 , 12 , 18 , and 24 months . Longitudinal mixed models were used to analyze change over time . RESULTS At 12 months , mean weight loss was 6.0 % of initial weight in the intervention group and 1.5 % in the control group ( P<.001 ) . At 24 months , mean weight loss in the intervention and control groups was 3.7 % and 1.3 % , respectively ( P<.001 ) . Favorable effects of the intervention on physical activity and blood pressure were observed . The weight loss intervention was more effective among women older than 55 years than among younger women . CONCLUSION A behavioral weight loss intervention can lead to clinical ly meaningful weight loss in overweight/obese survivors of breast cancer . These findings support the need to conduct additional studies to test methods that support sustained weight loss and to examine the potential benefit of intentional weight loss on breast cancer recurrence and survival The goal of evidence -based medicine is ultimately to improve patient outcomes and quality of care . Systematic review s of the available published evidence are required to identify interventions that lead to improvements in behavior , health , and well-being . Authoritative literature review s depend on the quality of published research and research reports . The Consoli date d St and ards for Reporting Trials ( CONSORT ) Statement ( www.consort-statement.org ) was developed to improve the design and reporting of interventions involving r and omized clinical trials ( RCTs ) in medical journals . We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence -based practice . Additional behavioral medicine-specific guidelines ( e.g. , treatment adherence ) are also presented . Use of these guidelines by clinicians , educators , policymakers , and research ers who design , report , and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice The purpose of the study is to evaluate the performance of theoretically-derived mediators of health behavior change . Participants were university seniors ( 184 females ; 154 males ) r and omly assigned to an intervention course design ed to promote physical activity or to a control course . Five physical activity outcomes and nine psychosocial mediating variables were assessed at baseline and the end of the 16-week course . For women , the intervention had significant effects on five of the mediators , including self-efficacy for making time , self-efficacy for resisting relapse , social support from friends , and experiential and behavioral processes of change . Among men , the intervention improved use of behavioral processes of change but also had the unintended effect of increasing perceived barriers to activity . For women , significant contributors to regressions explaining physical activity change were social support from friends ( for total activity ) and change in self-efficacy for resisting relapse ( for vigorous exercise ) . For men , significant explanatory variables included change in enjoyment ( for total activity ) , change in self-efficacy for resisting relapse ( for strength exercise ) , and change in benefits ( for moderate intensity activity ) . For both sexes , there were significant findings in the unexpected direction . Across the five physical activity outcomes , hypothesized mediators were inconsistent and weak contributors to the models . Investigating mediators of behavior change has the potential to stimulate improvements in theories and interventions Obese breast cancer survivors have increased risk of recurrence and death compared to their normal weight counterparts . Rural women have significantly higher obesity rates , thus weight control intervention may be a key strategy for prevention of breast cancer recurrence in this population . This one-arm treatment study examined the impact of a group-based weight control intervention delivered through conference call technology to obese breast cancer survivors living in remote rural locations . The intervention included a reduced calorie diet incorporating prepackaged entrees and shakes , physical activity gradually increased to 225 min/week of moderate intensity exercise , and weekly group phone sessions . Outcomes included anthropomorphic , diet , physical activity , serum biomarker , and quality of life changes . Ninety-one percent of participants ( 31 of 34 ) attended > 75 % of intervention sessions and completed post-treatment data collection visits . At 6 months , significant changes were observed for weight ( −12.5 ± 5.8 kg , 13.9 % of baseline weight ) , waist circumference ( −9.4 ± 6.3 cm ) , daily energy intake ( −349 ± 550 kcal/day ) , fruits , and vegetables ( + 3.7 ± 4.3 servings/day ) , percent kcal from fat ( −12.6 ± 8.6 % ) , physical activity ( + 1235 ± 832 kcal/week ; all P values < 0.001 ) , as well as significant reductions in fasting insulin ( 16.7 % reduction , P = 0.006 ) , and leptin ( 37.1 % reduction , P < 0.001 ) . Significant improvements were also seen for quality of life domains including mood , body image , and sexuality . In conclusion , the intervention produced > 10 % weight loss as well as significant improvements across multiple endpoints . The group phone-based treatment delivery approach may help disseminate effective weight control intervention to hard-to-reach breast cancer survivors OBJECTIVE Obesity is associated with poorer breast cancer outcomes and losing weight postdiagnosis may improve survival . As Hispanic and black women have poorer breast cancer prognosis than non-Hispanic whites diagnosed at similar age and stage , and have higher rates of obesity , effective weight loss strategies are needed . We piloted a r and omized , waitlist-controlled , crossover study to examine the effects and feasibility of the commercial Curves weight loss program among Hispanic , African American and Afro-Caribbean breast cancer survivors . DESIGN AND METHODS Women with stage 0-IIIa breast cancer ≥ 6 months posttreatment , sedentary , and BMI ≥ 25 kg/m(2 ) were r and omized to the immediate arm ( IA ) : 6 months of the Curves program followed by 6 months of observation ; or the waitlist control arm ( WCA ) : 6 months of observation followed by 6 months of the Curves program . The Curves program uses a 30-min exercise circuit and a high-vegetable/low-fat/calorie-restricted diet . RESULTS A total of 42 women enrolled ( 79 % Hispanic , 21 % black ) , mean age 51 ( range 32 - 69 ) and mean BMI 33.2(± 5.9 ) kg/m(2 ) ; 91 % were retained at month 12 . At month 6 , women in the IA lost an average 3.3 % ( ± 3.5 % ) of body weight ( range : 1.7 % gain to 10.6 % loss ) , as compared with 1.8 % ( ± 2.9 % ) weight loss in the WCA ( P = 0.04 ) . At month 12 , on average women in the IA regained some but not all of the weight lost during the first 6 months ( P = 0.02 ) . CONCLUSIONS Minority breast cancer survivors were recruited and retained in a weight loss study . Six months of the Curves program result ed in moderate weight loss , but weight loss was not maintained postintervention . Future interventions should identify methods to increase uptake and maintenance of weight loss behaviors OBJECTIVE The majority of endometrial cancer survivors ( ECS ) are obese and at risk for premature death . The purpose of this study was to evaluate an intervention for ECS to promote weight loss and a healthy lifestyle . METHODS Early stage overweight and obese ( body mass index ≥ 25 ) ECS ( N=75 ) were r and omized to a 6-month lifestyle intervention ( LI ) or usual care ( UC ) . The LI group received education and counseling for six months ( 10 weekly followed by 6 bi-weekly sessions ) . Weight change at 12 months was the primary endpoint . Secondary outcomes included fruit/vegetable servings/day and physical activity ( PA ) . Multiple imputations were used for missing data and mixed models were used to analyze changes from baseline . RESULTS Adherence was 84 % and follow-up data were available from 92 % of participants at 6 months and 79 % at 12 months . Mean [ 95 % CI ] difference in weight change between LI and UC groups at 6 months was -4.4 kg [ -5.3 , -3.5 ] , p<0.001 and at 12 months was -4.6 kg [ -5.8 , -3.5 ] , p<0.001 . Mean [ 95 % CI ] difference in PA minutes between groups at 6 months was 100 [ 6 , 194 ] , p=0.038 and at 12 months was 89 [ 14 , 163 ] , p=0.020 . Mean difference in kilocalories consumed was -217.8 ( p<0.001 ) at 6 months and -187.2 ( p<0.001 ) at 12 months . Mean [ 95 % CI ] difference in fruit and vegetable servings was 0.91 servings/day at 6 months and 0.92 at 12 months ( p<0.001 ) . CONCLUSIONS Behavior change and weight loss are achievable in overweight and obese ECS , however , the clinical implication s of these changes are unknown and require a larger trial with longer follow-up PURPOSE Diet and exercise interventions have been tested in cancer survivors as a means to reduce late effects and comorbidity , but few have assessed adherence and health outcomes long term . METHODS Between July 2005 and May 2007 , the Reach Out to Enhance Wellness ( RENEW ) trial accrued 641 locoregionally staged , long-term ( ≥ 5 years from diagnosis ) colorectal , breast , and prostate cancer survivors in the United States ( 21 states ) , Canada , and the United Kingdom . All participants were sedentary ( < 150 minutes of physical activity [ PA ] a week ) , overweight or obese ( body mass index , 25 to 40 kg/m(2 ) ) , and over age 65 years . The trial tested a diet-exercise intervention delivered via mailed print material s and telephone counseling . RENEW used a wait-list control , cross-over design ( ie , participants received the year-long intervention immediately or after a 1-year delay ) , which allowed the opportunity to assess program efficacy ( previously reported primary outcome ) , durability , and reproducibility ( reported herein ) . Measures included diet quality ( DQ ) , PA , BMI , and physical function ( PF ) . RESULTS No significant relapse was observed in the immediate-intervention arm for DQ , PA , and BMI ; however , rates of functional decline increased when the intervention ceased . From year 1 to year 2 , significant improvements were observed in the delayed-intervention arm ; mean change scores in behaviors and BMI and PF slopes were as follows : DQ score , 5.2 ( 95 % CI , 3.4 to 7.0 ) ; PA , 45.8 min/wk ( 9
Output:
| Implication s for cancer survivorsThis study contributed to increasing knowledge on the optimal strategy to achieve weight loss , which is recommended for overweight cancer survivors to improve health outcomes |
MS213147 | ***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: The purpose of this study was to estimate the national prevalence of childhood asthma and other allergic diseases in Korea , and to determine potential risk factors for the diseases . Stratified r and om sample s of 42,886 were selected from 34 elementary ( 6 - 12 yr olds ) and 34 middle schools ( 12 - 15 yr olds ) nationwide , and 38,955 were in the final analysis . The Korean-translated modified version of the International Study of Asthma and Allergies in Childhood question naire was used in this cross-sectional survey . Twelve-month prevalences of the symptoms of asthma , rhinoconjunctivitis , and flexural eczema were 8.7 % , 10.5 % , 7.3 % in 6 - 12 yr olds , and 8.2 % , 10.0 % , 3.9 % in 12 - 15 yr olds , respectively . For allergic conjunctivitis , food allergy , and drug allergy , the prevalences in 6 - 12 yr olds were 11.2 % , 6.5 % , and 1.5 % , respectively . Asthma and flexural eczema decreased significantly with age . Other significant risk factors were also noted . For 6 - 12 yr-old asthma , adjusted odds ratio ( aOR ) of body mass index was 1.21 with 95 % confidence interval ( CI ) 1.0 - 1.48 , aOR of passive smoking was 1.37 with 95%CI 1.24 - 1.51 , aOR of carpet use was 1.28 with 95%CI 1.10 - 1.49 . For 6 - 12 yr-old eczema , aOR of affluence was 1.22 with 95%CI 1.07 - 1.39 . The control of obesity and passive smoking would be the most important preventive measures of allergic diseases The chemokine ( C-X-C motif ) receptor 3 ( CXCR3 ) gene , on chromosome Xq13 , is known to have critical roles in inflammatory and immune responses . In an effort to discover polymorphisms have been implicated in asthma , we investigated the genetic polymorphisms in CXCR3 to evaluate it as a potential c and i date gene for a host genetic study of asthma . Statistical analysis revealed that one SNP in intron 1 , c.12 + 234 G > A , showed significant association with the risk of asthma development ( P = 0.007 , OR = 0.81 ) . By subgroup analyses stratified by gender and atopic status , the genetic effect of c.12 + 234 G > A on asthma was more apparent among male atopic subjects ( P = 0.0009 , OR = 0.61 ) . Our findings suggest that polymorphisms in CXCR3 might be one of the genetic factors for the risk of asthma development , especially in male atopic subjects . CXCR3 variation/haplotype information identified in this study will provide valuable information and insight into strategies for the control of asthma and its subgroup , atopy BACKGROUND It is important to diagnose asthma at an early stage as early treatment may improve the prognosis in the long term . However , many patients do not present at an early stage of the condition so the physician may have difficulty with the diagnosis . A study was therefore undertaken to compare the proportion of patients who underpresented their respiratory symptoms with the proportion of underdiagnosed cases of asthma by the general practitioner ( GP ) . A secondary aim was to investigate whether bad perception of dyspnoea by the patient was a determining factor in the underpresentation of asthma symptoms to the GP . METHODS A r and om sample of 1155 adult subjects from the general population in the eastern part of the Netherl and s was screened for respiratory symptoms and lung function and the results were compared with the numbers of asthma related consultations registered in the medical files of the GP . In subjects with reduced lung function the ability to perceive dyspnoea was investigated during a histamine provocation test in subjects who did and did not report their symptoms to their GP . RESULTS Of the r and om sample of 1155 subjects 86 ( 7 % ) had objective airflow obstruction ( forced expiratory volume in one second ( FEV1 ) below the reference value corrected for age , length , and sex minus 1.64SD on two occasions ) and had symptoms suggestive of asthma . Of these 86 subjects only 29 ( 34 % ) consulted the GP , which indicates underpresentation by 66 % of patients . Of all subjects with objective airflow obstruction who presented to their GP with respiratory symptoms , 23 ( 79 % ) were recorded in the medical files as having asthma , indicating underdiagnosis by the GP in 21 % of cases . Of the subjects with objective airflow obstruction who visited the GP with respiratory symptoms 6 % had bad perception of dyspnoea compared with 26 % of those who did not present to the GP in spite of airflow obstruction ( χ2 = 3.02 , p = 0.08 ) . CONCLUSIONS Underpresentation to GPs of respiratory symptoms by asthmatic patients contributes significantly to the problem of underdiagnosis of asthma . Underdiagnosis by the GP seems to play a smaller role . Furthermore , there are indications that underpresentation of symptoms by the patient is at least partly explained by a worse perception of dyspnoea Background Recent investigations have demonstrated that spider mites are important allergens in the development of asthma in fruit‐cultivating farmers
Output:
| Disease severity , level of control , and symptom state were all found to negatively impact the quality of life of asthmatics . |
MS213148 | ***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 authors sought to examine whether levels of dehydroepi and rosterone are abnormal in depression . METHODS Three groups of subjects aged 20 - 64 were studied : 44 major depressives , 35 subjects with partially or completely remitted depression , matched as far as possible for age and drug treatment , and 41 normal control subjects . Dehydroepi and rosterone and cortisol in saliva were determined from specimens taken at 8:00 AM and 8:00 PM on 4 days . RESULTS The mean age of the three groups did not differ . Dehydroepi and rosterone was lowered at 8:00 AM and 8:00 PM compared with control subjects . Values for the remitted group were intermediate . Dehydroepi and rosterone levels at 8:00 AM correlated negatively with severity of depression and were not related to drug treatment or smoking , but decreased with age ( as expected ) . Cortisol was elevated in depression in the evening . The molar cortisol/dehydroepi and rosterone ratio also differentiated those with depression from the control group . CONCLUSIONS Lowered dehydroepi and rosterone levels are an additional state abnormality in adult depression . Adrenal steroid changes are thus not limited to cortisol . Because dehydroepi and rosterone may antagonize some effects of cortisol and may have mood improving properties , these findings may have significant implication s for the pathophysiology of depression Background Puberty is a multifaceted developmental process that begins in late-childhood with a cascade of endocrine changes that ultimately lead to sexual maturation and reproductive capability . The transition through puberty is marked by an increased risk for the onset of a range of health problems , particularly those related to the control of behaviour and emotion . Early onset puberty is associated with a greater risk of cancers of the reproductive tract and cardiovascular disease . Previous studies have had method ological limitations and have tended to view puberty as a unitary process , with little distinction between adrenarche , gonadarche and linear growth . The Childhood to Adolescence Transition Study ( CATS ) aims to prospect ively examine associations between the timing and stage of the different hormonally-mediated changes , as well as the onset and course of common health and behavioural problems that emerge in the transition from childhood to adolescence . The initial focus of CATS is on adrenarche , the first hormonal process in the pubertal cascade , which begins for most children at around 8 years of age . Methods / Design CATS is a longitudinal population -based cohort study . All Grade 3 students ( 8–9 years of age ) from a stratified cluster sample of schools in Melbourne , Australia were invited to take part . In total , 1239 students and a parent/guardian were recruited to participate in the study . Measures are repeated annually and comprise student , parent and teacher question naires , and student anthropometric measurements . A saliva sample was collected from students at baseline and will be repeated at later waves , with the primary purpose of measuring hormonal indices of adrenarche and gonadarche . Discussion CATS is uniquely placed to capture biological and phenotypic indices of the pubertal process from its earliest manifestations , together with anthropometric measures and assessment of child health and development . The cohort will provide rich detail of the development , lifestyle , external circumstances and health of children during the transition from childhood through to adolescence . Baseline associations between the hormonal measures and measures of mental health and behaviour will initially be examined cross-sectionally , and then in later waves longitudinally . CATS will make a unique contribution to the underst and ing of adrenarche and puberty in children ’s health and development PURPOSE Mental and behavioral disorders increase in prevalence with the passage through puberty . Yet the first symptoms for many children emerge between seven and 11 years , before the pubertal rise in gonadal hormones . A possibility that symptom onset may be linked to the adrenarchal rise in and rogens has been little explored . METHODS The Childhood to Adolescence Transition Study recruited a stratified r and om sample of 1,239 eight-nine year olds from primary schools in Melbourne , Australia . Saliva sample s were assayed for dehydroepi and rosterone , dehydroepi and rosterone-sulphate ( DHEA-S ) , and testosterone . Emotional and behavioral problems were assessed through parental report on the Strengths and Difficulties Question naire . RESULTS In males , high levels of all and rogens were associated with greater total difficulties and peer problems . Higher dehydroepi and rosterone and testosterone were associated with emotional symptoms and DHEA-S with conduct problems . In females , DHEA-S was associated with peer problems . CONCLUSIONS In late childhood , and rogens are associated with emotional and behavioral problems in males , raising a possibility that the adrenarchal transition plays a contributing role . If so , the late primary school years may prove to be an important phase for preventing the onset of mental health and behavioral problems in boys Life history theorists have proposed that humans have evolved to be sensitive to specific features of early childhood environments and that exposure to different environments biases children toward development of different reproductive strategies , including differential pubertal timing . The current research provides a longitudinal test of this theory . Assessment s of family environments , based on interviews with mothers and fathers , were conducted in preschool , and children were then followed prospect ively through middle childhood . Adrenal hormones were assayed in a selected sub sample of 120 children ( 73 girls ) at age 7 , and parent and child reports of secondary sexual characteristics were collected in the full female sample of 180 girls at age 11 . Higher quality parental investment ( from both mothers and fathers ) and less father-reported Marital Conflict/Depression forecast later adrenarche . Older age at menarche in mothers , higher socioeconomic status , greater mother-based Parental Supportiveness , and lower third- grade body mass index each uniquely and significantly predicted later sexual development in daughters . Consistent with a life history perspective , quality of parental investment emerged as a central feature of the proximal family environment in relation to pubertal timing The steroid hormones , cortisol and dehydroepi and rosterone ( DHEA ) are the two main peripheral secretory products of the hypothalamic-pituitary-adrenal stress-neuroendocrine axis . The diurnal pattern of cortisol secretory activity has been well characterised . Various aspects of this pattern have been related to time of awakening , light exposure , psychological dimensions of affect , immune function and systemic health and well-being . DHEA is also an important adrenocortical steroid whose secretory activity has been related to immune function , psychological and health variables . The most pronounced feature of the diurnal cortisol cycle is a burst of secretory activity following awakening with a diurnal decline thereafter . We mapped DHEA secretory activity onto this cycle by measuring both steroids in saliva sample s collected at distinct time points over the diurnal cycle , synchronised to awakening . Both steroids , particularly DHEA , showed stability across days of sample collection . A main distinction between cortisol and DHEA was that although DHEA was elevated in post-awakening sample s compared with later in the day there was no evidence of an awakening stimulatory burst of DHEA secretory activity . Although DHEA in many respects paralleled cortisol secretory activity there was some dissociation ; mean levels were positively but not tightly correlated . The secretory pattern of DHEA is very stable whereas cortisol secretory activity seems more sensitive to day-to-day variability The aim of this study was to investigate associations between specific mental health problems and pubertal stage in (pre)adolescents participating in the Dutch prospect i ve cohort study TRAILS ( first assessment : N=2230 , age 11.09±0.56 , 50.8 % girls ; second assessment : N=2149 , age 13.56±0.53 , 51.0 % girls ) . Mental health was assessed by the Youth Self-Report , pubertal ( Tanner ) stage by parent-rated drawings of secondary sex characteristics . Overall , higher Tanner stages were related to more reported tiredness , irritability , rule-breaking behaviors , and substance use ; and fewer fears and somatic complaints . Girls showed increases in social uncertainty , depressed mood , and worries ; boys a decrease in self-criticism . Increasing problems during puberty were mostly related to the process of physical maturation , whereas decreasing problems were rather related to general age-related developments . Pubertal timing was associated with different symptoms than pubertal status or age . Puberty seems to affect girls more negatively than boys BACKGROUND The evidence for a role of and rogens in human aggression is less convincing than in animals . We examined the relationship between and rogens and aggression in prepubertal boys who were diagnosed as suffering from severe aggression and antisocial behavior . METHODS Plasma levels of testosterone ( T ) , and rostenedione ( A ) , and dehydroepi and rosterone sulphate ( DHEAS ) were measured in 15 boys with a conduct disorder ( CD ) and 25 normal control ( NC ) boys . Parents and teachers of the children rated the intensity of aggression and delinquency over the last 6 months . RESULTS CD boys had significantly higher levels of DHEAS and marginally significantly higher levels of A ; there were no differences in T. Moreover , DHEAS levels were significantly positively correlated with the intensity of aggression and delinquency as rated by both parents and teachers . CONCLUSIONS The results suggest that adrenal and rogen functioning plays an important role in the onset and maintenance , of aggression in young boys OBJECTIVE Early pubertal timing in girls is associated with psychosocial problems throughout adolescence , but it is unclear whether these problems persist into young adulthood . The authors analyzed outcomes in adolescence and young adulthood in girls in a longitudinal study . METHOD The data for this study were from the prospect i ve population -based Great Smoky Mountains Study ( N=1,420 ) , which initially recruited children at ages 9 , 11 , and 13 and followed them into young adulthood . Pubertal timing was defined on the basis of self-reported Tanner stage and age at menarche . Outcome measures included functioning related to crime , substance use , school/peer problems , family relationships , sexual behavior , and mental health in adolescence ( ages 13 to 16 ) as well as crime , substance use , education/socioeconomic status , sexual behavior , and mental health in young adulthood ( ages 19 and 21 ) . RESULTS In adolescence , early-maturing girls displayed higher levels of self-reported criminality , substance use problems , social isolation , early sexual behavior , and psychiatric problems . By young adulthood , most of these differences had attenuated . Functioning for early maturers improved in some areas ; in others , on-time and late maturers had caught up with their early-maturing peers . Nevertheless , early-maturing girls , particularly those with a history of adolescent conduct disorder , were more likely to be depressed in young adulthood compared to their counterparts . Early maturers were also more likely to have had many sexual partners . CONCLUSIONS The effects of early pubertal timing on adolescent psychosocial problems were wide ranging but diminished by young adulthood for all but a small group Dehydroepi and rosterone sulfate ( DHEAS ) , which is of almost exclusive adrenal origin , is important for the and rogen status in women and prepubertal children , and DHEAS assays are used in the investigation of hyper and rogenism . There are conflicting reports concerning a diurnal variation in serum DHEAS . Although of adrenocortical origin , serum DHEAS levels are decreased by oral contraceptives ( OCs ) . DHEAS is strongly bound to serum albumin and has a very low metabolic clearance rate . The present study was performed in order to investigate whether a diurnal variation in serum DHEAS exists and , if so , whether this diurnal variation and the decreased DHEAS levels following OC use are related to alterations in adrenocortical steroids or to changes in serum albumin . Serum concentrations of DHEAS , dehydroepi and rosterone ( DHEA ) , cortisol and albumin were determined in blood sample s taken every half hour over a 24-h period in 10 healthy women before and during use of combined OCs . Significant and frequently synchronous diurnal variations in serum DHEAS and albumin were found before as well as during OC use . These variations were not synchronous with the diurnal variation in DHEA . OCs significantly decreased serum DHEAS and albumin levels . A multiple regression analysis showed changes in albumin to be the most decisive factor for the diurnal variation as and for OC-induced changes in DHEAS . Changes in serum DHEAS during the day and following OC use are related to alterations in its main binding protein , serum albumin , rather than to changes in adrenocortical steroid secretion
Output:
| In general , studies showed that earlier timing of adrenarche was associated with greater mental health symptoms , and there is emerging support that brain development plays a role in this relationship . |
MS213149 | ***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: Little is known about the cognitive factors associated with adherence to antiestrogen therapy . Our objective was to investigate the association between domain-specific cognitive function and adherence among women in a clinical prevention trial of oral antiestrogen therapies . We performed a secondary analysis of Co-STAR , an ancillary study of the STAR breast cancer prevention trial in which postmenopausal women at increased breast cancer risk were r and omized to tamoxifen or raloxifene . Co-STAR enrolled nondemented participants ≥65 years old to compare treatment effects on cognition . The cognitive battery assessed global cognitive function ( Modified Mini-Mental State Exam ) , and specific cognitive domains of verbal knowledge , verbal fluency , figural memory , verbal memory , attention and working memory , spatial ability , and fine motor speed . Adherence was defined by a ratio of actual time taking therapy per protocol ≥80 % of expected time . Logistic regression was used to evaluate the association between cognitive test scores and adherence to therapy . The mean age of the 1,331 Co-STAR participants was 67.2 ± 4.3 years . Mean 3MS score was 95.1 ( 4.7 ) and 14 % were nonadherent . In adjusted analyses , the odds of nonadherence were lower for those with better scores on verbal memory [ OR ( 95 % confidence interval ) : 0.75 ( 0.62–0.92 ) ] . Larger relative deficits in verbal memory compared with verbal fluency were also associated with nonadherence [ 1.28 ( 1.08–1.51 ) ] . Among nondemented older women , subtle differences in memory performance were associated with medication adherence . Differential performance across cognitive domains may help identify persons at greater risk for poor adherence . Cancer Prev Res ; 7(1 ) ; 161–8 . © 2013 AACR Background . Patients cite " forgetting " as a reason for nonadherence to highly active antiretroviral therapy ( HAART ) . We measured the effect of a memory-prompting device on adherence to HAART in memory-intact and memory-impaired human immunodeficiency virus (HIV)-infected subjects . Methods . The study was a prospect i ve , r and omized , controlled trial involving 64 HIV-infected adults . The intervention was the Disease Management Assistance System ( DMAS ) device , combined with monthly adherence counseling . Control subjects received only adherence counseling . The DMAS was programmed with HAART regimen data to provide verbal reminders at dosing times . Adherence was measured for 24 weeks using electronic drug exposure monitor ( eDEM ) caps . Results . A total of 58 subjects completed the 24-week study period ; 28 were HAART naive ( 12 DMAS users and 16 control subjects ) . Mean adherence scores did not differ significantly between DMAS users ( 80 % ) and control subjects ( 65 % ) . Post hoc analysis of 31 memory-impaired subjects ( 14 DMAS users and 17 control subjects ) revealed significantly higher adherence rates among DMAS users ( 77 % ) , compared with control subjects ( 57 % ) ( P=.001 ) . However , analysis of memory-intact subjects showed that adherence was not significantly improved for DMAS users ( 83 % ) , compared with control subjects ( 77 % ) ( P=.25 ) . At week twelve , 38 % of the DMAS users and 14 % of the control subjects had an undetectable plasma HIV RNA load ( P=.014 ) , and at week 24 , the plasma HIV RNA load was undetectable for 34 % of the DMAS users and 38 % of the control subjects ( P=.49 ) . CD4(+ ) cell counts did not differ between the study arms . Virological and immunological responses were not related to DMAS use in memory-impaired subjects . Conclusion . The DMAS prompting device improved adherence for memory-impaired subjects but not for memory-intact subjects BACKGROUND : Non-adherence in hypertension is a global problem and promoting adherence is necessary to decrease cardiovascular mortality . AIMS : The purpose of this paper is to examine the measurement of adherence to medication taking in hypertensive patients . Adherence was evaluated primarily by means of MEMS ( Medication Event Monitoring System , Aprex Corporation , Fremont , California ) an electronic system that records the date and time of opening of the study medication container . Additional measurements such as change in urinary potassium level , capsule count , client self report and physician estimate of adherence were recorded . METHODS : A r and omised clinical trial was used to assign patients to receive the study medication ( potassium ) or placebo . Descriptive statistics were used to answer the research questions . Frequency and percentage of responses to different measures of adherence were carried out as well as correlation between the measures . RESULTS : One hundred and seven subjects between the ages of 26 and 80 participated in the clinical trial . The results showed that adherence measures varied with lowest adherence from two items of self-report related to forgetfulness ( 46 and 55 % ) and stringent electronic monitoring with the MEMS ( 58 % ) to percentages in the 80–90 range for other self-report items and the general adherence scale . Electronic monitoring correlated best with capsule count at visit 5 . Implication s for health care providers are discussed OBJECTIVE The aim of this study was to prospect ively examine the influence of cognitive , medical , behavioral , and social risk factors on medication nonadherence in community-dwelling older adults with cognitive impairment . METHODS A sample of 339 elderly participants with cognitive impairment , who lived alone and took at least one medication , underwent baseline assessment which included the five subscales of the Dementia Rating Scale ( DRS ) , number of medications , retrospective medication nonadherence , amount of formal and informal assistance , functional impairment , depression , perception of social re sources , comorbidity , and alcohol consumption . The outcome was medication nonadherence during the 12-month prospect i ve period as reported by the participants ' primary care physicians and caregivers at three-month intervals . RESULTS Fifty-nine participants ( 17.4 % ) had , at least , one report of medication nonadherence . Logistic regression analyses indicated for every point increase on the DRS Conceptualization subscale ( OR = 1.14 ; 95 % CI = 1.02 - 1.27 ) , there was a 14 % increase in the odds of nonadherence . For every point increase on the DRS Memory subscale ( OR = 0.89 ; 95 % CI = 0.81 - 0.97 ) and DRS Initiation/Perseveration subscale ( OR = 0.93 ; 95 % CI = 0.87 - 1.00 ) , there was an 11 % decrease and 7 % decrease in the odds , respectively . Having at least one previous occurrence of medication nonadherence ( OR = 2.61 ; 95 % CI = 1.18 - 5.62 ) and taking at least four medications ( OR = 2.58 ; 95 % CI = 1.31 - 5.29 ) , both increased the odds by over 2.5-fold . CONCLUSIONS Our unique finding that better conceptualization predicted nonadherence has important implication s for healthcare providers ' approaches to improve adherence in older adults with cognitive impairment . Replication in future studies is warranted OBJECTIVE Medication nonadherence has been a persistent problem over the past three decades ; forgetting and being distracted from regular routines are the barriers most frequently cited by patients . Prior research on cognitive function and medication adherence has yielded mixed results . DESIGN This report compares findings of three studies : All were longitudinal , two were r and omized controlled intervention trials , and one was descriptive . Sample s of adult patients taking once daily lipid-lowering medication , diabetic patients with comorbid conditions on complex regimens , and early stage breast cancer patients on hormonal therapy completed similar batteries of st and ardized , valid , neuropsychological tests at baseline . MAIN OUTCOME MEASURES Adherence to medication regimens , over time , was tracked with electronic event monitors . RESULTS Medication nonadherence was prevalent in all studies . Deficits in attention/mental flexibility and /or working memory predicted nonadherence in all studies ; impaired executive function was related to poor adherence in one study . CONCLUSION These findings suggest that better mental efficiency may be the key to better medication adherence with any regimen , and that targeted cognitive functions , which can be easily and quickly assessed , may identify patients at risk of poor adherence regardless of diagnosis or regimen
Output:
| New-learning , memory and executive functioning were associated with improved adherence and formed the focus of most studies .
Multiple factors were identified as modulators of non-adherence .
This review highlights a gap in knowledge on how specific cognitive domains contribute to medication non-adherence amongst CI population s , and demonstrates the current focus is limited to two domains : memory and executive functioning |
MS213150 | ***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: Most patients with advanced or metastatic cancer experience pain and despite several guidelines , undertreatment is well documented . A multicenter , open-label , prospect i ve , non-r and omised study was launched in Italy in 2006 to evaluate the epidemiology , patterns and quality of pain care of cancer patients . To assess the adequacy of analgesic care , we used a st and ardised measure , the pain management index ( PMI ) , that compares the most potent analgesic prescribed for a patient with the reported level of the worst pain of that patient together with a selected list of clinical indicators . A total of 110 centres recruited 1801 valid cases . 61 % of cases were received a WHO-level III opioid ; 25.3 % were classified as potentially undertreated , with wide variation ( 9.8–55.3 % ) according to the variables describing patients , centres and pattern of care . After adjustment with a multivariable logistic regression model , type of recruiting centre , receiving adjuvant therapy or not and type of patient recruited ( new or already on follow-up ) had a significant association with undertreatment . Non-compliance with the predefined set of clinical indicators was generally high , ranging from 41 to 76 % . Despite intrinsic limitations of the PMI that may be considered as an indicator of the poor quality of cancer pain care , results suggest that the recourse to WHO third-level drugs still seems delayed in a substantial percentage of patients . This delay is probably related to several factors affecting practice in participating centres and suggests that the quality of cancer pain management in Italy deserves specific attention and interventions aim ed at improving patients ’ outcomes CONTEXT Published literature has not defined the effectiveness of st and ardized educational tools that can be self-administered in the general oncology population with pain . OBJECTIVES We sought to determine if an educational intervention consisting of a video and /or booklet for adults with cancer pain could improve knowledge and attitudes about cancer pain management , pain levels , pain interference , anxiety , quality of life , and analgesic use . METHODS Eligible participants had advanced cancer , a pain score > /=2 of 10 in the last week , English proficiency , an estimated prognosis of more than one month , and were receiving outpatient cancer treatment at participating hospitals . Participants completed baseline assessment s and then were r and omly allocated to receive a booklet , a video , both , or neither , in addition to st and ard care . Outcome measures at two and four weeks included the Barriers Question naire ( BQ ) , Brief Pain Inventory , Global Quality of Life Scale , and Hospital Anxiety and Depression Scale . Adequacy of analgesia and severity of pain were assessed with the Pain Management Index and a daily pain diary . RESULTS One hundred fifty-eight participants were recruited from 21 sites over 42 months . Baseline mean barriers scores were lower than reported in previous Australian studies at 1.33 ( st and ard deviation : 0.92 ) . Mean average pain and worst pain scores improved significantly in patients receiving both the video and booklet by 1.17 ( st and ard error [ SE ] : 0.51 , P=0.02 ) and 1.12 ( SE : 0.57 , P=0.05 ) , respectively , on a 0 - 10 scale . The addiction subscale of the BQ score was improved by 0.44 ( SE : 0.19 ) for participants receiving any part of the intervention ( P=0.03 ) . CONCLUSION Provision of a video and /or booklet for people with cancer pain was a feasible and effective adjunct to the management of cancer pain PURPOSE An American Society of Clinical Oncology ( ASCO ) provisional clinical opinion ( PCO ) offers timely clinical direction to ASCO 's membership following publication or presentation of potentially practice -changing data from major studies . This PCO addresses the integration of palliative care services into st and ard oncology practice at the time a person is diagnosed with metastatic or advanced cancer . CLINICAL CONTEXT Palliative care is frequently misconstrued as synonymous with end-of-life care . Palliative care is focused on the relief of suffering , in all of its dimensions , throughout the course of a patient 's illness . Although the use of hospice and other palliative care services at the end of life has increased , many patients are enrolled in hospice less than 3 weeks before their death , which limits the benefit they may gain from these services . By potentially improving quality of life ( QOL ) , cost of care , and even survival in patients with metastatic cancer , palliative care has increasing relevance for the care of patients with cancer . Until recently , data from r and omized controlled trials ( RCTs ) demonstrating the benefits of palliative care in patients with metastatic cancer who are also receiving st and ard oncology care have not been available . RECENT DATA Seven published RCTs form the basis of this PCO . PROVISIONAL CLINICAL OPINION Based on strong evidence from a phase III RCT , patients with metastatic non-small-cell lung cancer should be offered concurrent palliative care and st and ard oncologic care at initial diagnosis . While a survival benefit from early involvement of palliative care has not yet been demonstrated in other oncology setting s , substantial evidence demonstrates that palliative care-when combined with st and ard cancer care or as the main focus of care-leads to better patient and caregiver outcomes . These include improvement in symptoms , QOL , and patient satisfaction , with reduced caregiver burden . Earlier involvement of palliative care also leads to more appropriate referral to and use of hospice , and reduced use of futile intensive care . While evidence clarifying optimal delivery of palliative care to improve patient outcomes is evolving , no trials to date have demonstrated harm to patients and caregivers , or excessive costs , from early involvement of palliative care . Therefore , it is the Panel 's expert consensus that combined st and ard oncology care and palliative care should be considered early in the course of illness for any patient with metastatic cancer and /or high symptom burden . Strategies to optimize concurrent palliative care and st and ard oncology care , with evaluation of its impact on important patient and caregiver outcomes ( eg , QOL , survival , health care services utilization , and costs ) and on society , should be an area of intense research . NOTE ASCO 's provisional clinical opinions ( PCOs ) reflect expert consensus based on clinical evidence and literature available at the time they are written and are intended to assist physicians in clinical decision making and identify questions and setting s for further research . Because of the rapid flow of scientific information in oncology , new evidence may have emerged since the time a PCO was su bmi tted for publication . PCOs are not continually up date d and may not reflect the most recent evidence . PCOs can not account for individual variation among patients and can not be considered inclusive of all proper methods of care or exclusive of other treatments . It is the responsibility of the treating physician or other health care provider , relying on independent experience and knowledge of the patient , to determine the best course of treatment for the patient . Accordingly , adherence to any PCO is voluntary , with the ultimate determination regarding its application to be made by the physician in light of each patient 's individual circumstances . ASCO PCOs describe the use of procedures and therapies in clinical trials and can not be assumed to apply to the use of these interventions in the context of clinical practice . ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO 's PCOs , or for any errors or omissions BACKGROUND No study has so far addressed whether differences do exist in the management of cancer-related pain in patients admitted to oncology and non-oncology setting s. PATIENTS AND METHODS A multicentre cross-sectional study in 48 Italian hospitals has enrolled 819 patients receiving analgesic therapy for cancer-related pain . Demographics and clinical and analgesic therapy information have been prospect ively collected by st and ardized forms . Adequacy of pain management has been evaluated by the Pain Management Index ( PMI ) . RESULTS Differences in the analgesic drug administration according to setting s of care have been evident , non-opioids more frequently being administered in non-oncology units ( 19.6 % versus 7.0 % ; P < 0.0001 ) , while strong opioids are more frequently used in the oncology units ( 69.5 % versus 51.9 % ; P < 0.0001 ) . The number of patients receiving inadequate therapy ( PMI < 0 ) has lowered in oncology compared with non-oncology units ( 11.3 % versus 18.8 % ; P = 0.0024 ) . Results of multiple logistic regression analysis have shown that the admission to non-oncology setting [ odds ratio ( OR ) = 1.75 , 95 % confidence interval ( CI ) = 1.15 - 2.67 ; P = 0.0096 ] and the absence of metastatic disease ( OR = 1.60 , 95 % CI = 1.04 - 2.44 ; P = 0.0317 ) were independent factors associated with an increased risk of receiving an inadequate analgesic therapy . CONCLUSION Oncology wards provide the most adequate st and ard of analgesic therapy for cancer-related pain & NA ; Two hundred and sixty‐three ambulatory patients older than 21 years of age who were attending clinics at an oncology hospital in San Juan , Puerto Rico , were studied . They completed a question naire ( BQ‐PR ) that measures 8 concerns about reporting pain and using analgesics , such as fears of addiction and tolerance and the belief that reporting pain can distract a physician from focusing on curing one 's disease . Ninety percent of the patients had at least some concern about each of the 8 topics , and mean scores on the 8 subscales were near the midpoint on a 0–5 scale . There were significant inverse relationships between level of education , income , and BQ‐PR total score . Those persons who experienced cancer‐related pain on the day they completed the question naire were categorized as using adequate versus not adequate analgesic medication , a determination that was based on a comparison of their level of pain to the medication they were using . Those who were not using adequate analgesic medication had higher BQ‐PR total scores than did those who were using adequate medication Few studies have evaluated sex differences in the adequacy of pain management in cancer . Existing studies have been marked by method ological limitations and results have been mixed . The present study sought to determine whether sex was associated with pain severity and pain management in cancer patients newly referred by their primary oncology team to a multidisciplinary cancer pain clinic . One hundred thirty-one cancer patients completed the Brief Pain Inventory-Short Form and medical chart review was conducted to obtain patients ' clinical characteristics and pain treatment data . There were no differences between males and females in ratings of worst pain in the last week . Females were significantly less likely to have been prescribed high potency opioids by their primary oncology team and significantly more likely to report inadequate pain management as measured by Pain Management Index scores . These results suggest a sex bias in the treatment of cancer pain and support the routine examination of the effect of sex in cancer pain research OBJECTIVE This analysis , carried out in the context of a wider observational prospect i ve study , tried to explore whether four World Health Organization/step-III opioids ( morphine , oxycodone , fentanyl , and buprenorphine ) had different effectiveness when using several different outcomes and endpoints . DESIGN Cross-sectional and longitudinal design . SETTING Oncologic , palliative , and pain centers in Italy . PATIENTS Two hundred fifty-eight cancer patients monitored over a 3-week follow-up program . Intervention . Not applicable . OUTCOME MEASURES The analgesic efficacy was assessed using effectiveness endpoints , such as pain intensity , pain intensity difference ( PID ) , proportion of nonresponders ( NR ) and full-responders ( FR ) subjects , percentage of switches and dose escalation . RESULTS Mean values of PID led to differences among opioids ranging from 10 % to 30 % . FR ( PID ≥ 30 % ) were more frequent in buprenorphine-fentanyl-oxycodone groups than in morphine ; NR ( PID ≤ 0 % ) were variable . The percentage of switches result ed three times more frequent when using morphine than buprenorphine ( 24.4 % vs 8.6 % ) . An increase of dose ≥ 5 % a day was observed in 33.3 % of fentanyl patients vs 15 % of buprenorphine . As a whole , opioids show some different behaviors on the basis of the considered endpoints . CONCLUSIONS The observed results , even if the small sample size and the nature itself of the study do not allow a definitive evaluation of the effectiveness of the drugs , underline a degree of variability among opioids and address toward a correct planning of a comparative r and omized clinical trial that is now underway in Italy . For this reason , a confirmative effectiveness r and omized controlled trial is required PURPOSE S Determine adequacy of management of pain secondary to bone metastases by physicians referring to specialized outpatient palliative radiotherapy ( RT ) clinics in Canada ; compare geographic differences in adequacy of pain management and pain severity between these cohorts ; compare results with published international literature . METHODS Prospect ively collected data from three participating centers were used to calculate the Pain Management Index ( PMI ) by subtracting the patient-rated pain score at time of initial clinic visit from the analgesic score . Scores were 0 , 1 , 2 , and 3 when patients reported no pain ( 0 ) , mild ( 1 - 4 ) , moderate ( 5 - 6 ) , or severe pain ( 7 - 10 ) , respectively , on the Edmonton Symptom Assessment System or Brief Pain Inventory . Analgesic scores of 0 , 1 , 2 , and 3 were assigned for no pain medication , nonopioids , weak opioids , and strong opioids respectively . A negative PMI suggests inadequate pain management . R
Output:
| Analysis of 46 articles published from 1994 to 2013 using the PMI to assess the adequacy of analgesic therapy suggests the quality of pharmacologic pain management has improved .
However , approximately one third of patients still do not receive pain medication proportional to their pain intensity |
MS213151 | ***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 r and omized clinical trial was undertaken to compare the effectiveness of two partial denture design s , one with I-bar ( bar ) and the other with circumferential retainers ( circumferential ) , in 134 patients with Kennedy class I and class II edentulous conditions . A total of 30 partial dentures were considered failures , five because of abutment failures and 25 because of the lack of removable partial denture use for eating . The 5-year success rate of 71.3 % for the circumferential design did not differ significantly from the 76.6 % for the bar design ( p > 0.05 ) . There were no discernible changes in the nine periodontal health components of abutment teeth with either of the two design s after 60 months . The results indicate that the two design s do not differ significantly in terms of success rates , maintenance care , and effects on abutment teeth . A well-constructed removable partial denture of either design , supported by favorable abutments and accompanied by a regular recall program offers a satisfactory treatment modality Objectives The study was design ed to provide clinical outcome data for two treatments of the shortened dental arch ( SDA ) . Material and Methods In a multicenter r and omized controlled clinical trial , patients with complete molar loss in one jaw were provided with either a partial removable dental prosthesis ( PRDP ) retained with precision attachments or treated according to the SDA concept preserving or restoring a premolar occlusion . No implants were placed . The primary outcome was tooth loss . Results Of 152 treated patients , 132 patients reached the 5-year examination . Over 5 years , 38 patients experienced tooth loss . For the primary outcome tooth loss , the Kaplan – Meier survival rates at 5 years were 0.74 ( 95 % CI 0.64 , 0.84 ) in the PRDP group and 0.74 ( 95 % CI 0.63 , 0.85 ) in the SDA group . For tooth loss in the study jaw , the survival rates at 5 years were 0.88 ( 95 % CI 0.80 , 0.95 ) in the PRDP group and 0.84 ( 95 % CI 0.74 , 0.93 ) in the SDA group . The differences were not significant . No Cox regression models of appropriate fit explaining tooth loss on the patient level could be found . Conclusions The overall treatment goals of a sustainable oral rehabilitation and the avoidance of further tooth loss over longer periods were not reliably achievable . The influence of the type of prosthetic treatment on tooth loss might have been overestimated . Clinical Relevance Regarding our results , the patient ’s view will gain even more importance in the clinical decision between removable and fixed restorations in SDAs Removable partial dentures may adversely affect remaining tissues and have a low prevalence of use . This r and omized controlled trial was design ed to compare the time to survival of cantilever resin-bonded fixed partial dentures and conventional removable partial dentures to restore shortened lower dental arches . We r and omly allocated 25 male and 35 female patients ( median age , 67 years ) to fixed or removable partial denture groups of 30 persons , matched for age and sex . Survival of the prostheses was assessed , based on listed criteria , at each review or when problems arose . Although the removable partial denture group required rather more maintenance visits , the difference in survival rates was not statistically significant ( hazard ratio = 0.59 , with 95 % CI 0.27 , 1.29 ) . In the absence of significant differences in five-year survival , the reported advantages of fixed partial dentures , including reduced maintenance frequency , offer positive support for the use of resin-bonded fixed partial dentures STATEMENT OF PROBLEM It is important to evaluate the long-term clinical performance of resin-bonded fixed partial dentures and extracoronal attachments for removable prostheses . PURPOSE A prospect i ve , long-term clinical study was conducted to evaluate the success of resin-bonded fixed partial dentures since 1985 and of resin-bonded extracoronal attachments from 1987 . METHODS Until 1993 , a total of 130 resin-bonded fixed partial dentures had been seated in 101 patients , as well as 12 removable partial dentures ( RPDs ) with 24 extracoronal retainers in 10 patients . The clinical treatment protocol and the laboratory procedures were st and ardized . By the end of 1993 , it was possible to reexamine 98 patients with a total of 127 resin-bonded fixed partial dentures and all 10 patients with removable partial dentures . The average time in function for the resin-bonded fixed partial dentures at the time of examination was 3.4 years and 2.3 years for the removable restorations . RESULTS During the period of observation , one retainer failed on six of the resin-bonded fixed partial dentures , which represents a failure rate of 4.7 % . Debonding of extracoronal attachments was recorded for 8.3 % of the total number of retainers . CONCLUSION The resin-bonded fixed partial denture technique can be considered to be a clinical ly reliable method of treatment , and permits the expansion of indications beyond a classical three-unit resin-bonded fixed partial denture . Long-term clinical success of removable partial dentures with resin-bonded extracoronal retainers warrants additional clinical studies Five Veterans Administration centers have participated in a study to determine whether fixed partial dentures ( FPDs ) supported by blade implants offer an acceptable substitute for m and ibular unilateral or bilateral distal-base extension removable partial dentures ( RPDs ) . The study design and methodology have been described in Part I. A total of 232 patients received comprehensive dental care including RPDs for 118 patients and FPDs for 114 . Prespecified criteria determined treatment failures . During the 60-month period , treatment failures occurred in 19 FPD patients and 30 RPD patients . Ten FPD failures occurred before and nine after the FPD insertion . Five RPD failures were caused by abutment tooth loss and 25 for not using the RPD while eating . Life table analysis showed 5-year success rates of 84.2 % for the FPD and 74 % for the RPD . The 17.9 % higher FPD success rate in Kennedy class II patients was both statistically and clinical ly significant . Excluding the 10 early failures , the 5-year FPD success rate was 91.5 % . Of the 170 attempted implants , 26 failed , including 12 before the FPD fabrication . Radiographic assessment s by a panel of three judges showed no bone deterioration during baseline to 60 months in 29.6 % , slight in 25.4 % , moderate in 15.9 % , marked in 27 % , and severe deterioration in 2.1 % of the implant posts CONTEXT Removable partial dentures used to restore the shortened lower dental arch may adversely affect the remaining natural teeth and are associated with a low prevalence of use . OBJECTIVE To report the findings for caries incidence 2 years after restoration of lower shortened arches with bilateral cantilever resin-bonded bridges ( RBBs ) and conventional partial dentures ( RPDs ) . DESIGN R and omised controlled trial . SETTING Secondary care PATIENTS 25 male and 35 female subjects of median age 67 years . were r and omly allocated to ' bridge ' and ' denture ' treatment groups of 30 patients each matched for age and sex . Caries incidence was recorded during dental examinations 3 months , 1 and 2 years after insertion of new lower prostheses . INTERVENTIONS Cantilever RBBs and conventional RPDs with cast metal frameworks . RESULTS There was a highly significant difference in the frequency of new caries lesions , 11 and 51 in the bridge and denture groups respectively ( P < 0.01 ) . 20 out of 27 bridge patients and 9 of 23 denture patients had no caries experience . Multivariate modeling identified treatment group as the only significant predictor of caries occurrence . CONCLUSIONS Two years after restoration of lower shortened arches for an elderly sample of patients , there was a significantly greater incidence of new and recurrent caries lesions in subjects restored with RPDs compared with cantilever RBBs This study examined the success of titanium ( Ti ) removable partial dentures ( RPDs ) compared with that of cobalt-chromium ( Co-Cr ) RPDs using a r and omized controlled clinical trial . Thirty-eight RPD patients were provided with either Co-Cr ( 20 patients ) or Ti ( 18 patients ) RPDs . The total numbers of dentures was 31 ( 13 maxillary , 18 m and ibular ) for Co-Cr and 23 ( 11 maxillary , 12 m and ibular ) for Ti . Patients were review ed for 24 months following denture issue . After the initial 12 months , 20 clinical problems were recorded and became the criteria for subsequent assessment . Incidence of failure was analysed using both Fisher 's exact test and the chi square test at a significance level of P<0.05 . Fracture of retainers in both metals occurred only in the first 12 months . Some failure types presented at significantly higher levels in the first 12 months but there were no significant differences between the two in all the criteria examined between the 12- and the 24-month review s. Although differences existed in failure types between Co-Cr and Ti RPDs during the early review stages , the overall success rate of Ti RPDs was comparable with that of Co-Cr RPDs after 24 months . The higher incidence of failures in Ti RPDs prior to the 12-month review suggests the importance of taking its lower rigidity into account when design ing RPDs PURPOSE The aim of this study was to quantify and compare the clinical performance of cast conical double crown-retained removable partial dentures ( C-RPDs ) and electroplated double crown-retained removable partial dentures ( EP-RPDs ) . MATERIAL S AND METHODS A total of 60 RPDs were placed in 54 patients . Participants were r and omly assigned to two study groups ( C-RPD and EP-RPD ) . Altogether , 217 abutment teeth were provided with double crowns . Patients were reexamined after 6 , 12 , 24 , and 36 months . The main endpoints were the survival times of RPDs and abutment teeth ; secondary endpoints included failure of the facing , loss of cementation of primary crowns , and postprosthetic endodontic treatment . Chi-square tests were used to evaluate group differences regarding characteristics of patients and RPDs . Survival differences were investigated using the log-rank test and Cox regression ; secondary endpoints were assessed using logistic regression . RESULTS After 36 months , survival was 100 % for C-RPDs and 93.3 % for EP-RPDs . Cumulative survival for abutment teeth was 97.3 % ( C-RPDs ) and 96.2 % ( EP-RPDs ) . Survival differences between the two study groups did not reach statistical significance . The survival of abutments depended on tooth vitality and position ; for example , the hazard of tooth loss was 676 % higher for nonvital teeth . No differences were found between study groups regarding facing failure , decementation of primary crowns , or postprosthetic endodontic treatment . CONCLUSIONS Vitality and position are important to the survival of teeth supporting partial dentures . Longer follow-up and larger patient collectives are needed to evaluate possible differences between cast conical and electroplated telescopic double crown-retained partial dentures Prosthesis function and dental conditions were observed for 5 years in 27 elderly patients treated with m and ibular cantilevered fixed partial dentures ( FPDs ) and in 26 elderly patients treated with distal-extension removal partial dentures ( RPDs ) . All patients were treated with a complete upper denture . The patients were assigned r and omly into two treatment groups that had the same composition with regard to sex , age , and distribution of teeth . The patients were under supervised oral hygiene and prosthodontic care . Clinical examination of prostheses , masticatory system , periodontal status , and caries was carried out yearly . Oral hygiene was good , and the periodontal status was maintained in both groups . Caries was observed six times more frequently in the RPD group than in the group with fixed restorations , however . Occlusal and functional conditions deteriorated in the RPD group only . Eight of 42 fixed partial dentures ( 19 % ) failed ; of these , six were recemented with composite resin . Generally the need for dental and prosthetic follow-up treatment was more pronounced in the RPD group than in the FPD group
Output:
| The better the pre-treatment and supportive care is , the smaller the differences are .
The results for the parameters probing depth and radiological bone loss were inconclusive .
Gingival recessionGingival recession seemed to be favored by a m and ibular sublingual bar .
Compared to fixed restorations , removable restorations seemed to be associated with a more pronounced need for dental treatment .
Stringent pre-treatment and supportive care reduced the complication rates .
Clinical relevance Within the limitations of this study , it would be correct to state that removable dental prostheses require intensive maintenance .
Suitable pre-treatment and supportive care can lower the complication rates , in the absence of which they constitute trigger factors for ( additional ) biological complications |
MS213152 | ***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: Large wounds result ing from severe injuries are generally treated with extended reconstructive operations ( e.g. , free flaps ) , which are accompanied by long hospitalizations and risks of infection , thrombosis , and flap loss . Integra is a collagen template that can be used for reconstruction of defects . The take rate and the rate of infection are essential for the successful use of Integra ( Johnson and Johnson , Hamburg , Germany ) . Whether the take rate and integration of Integra could be improved with the use of fibrin glue and negative-pressure therapy was assessed . Between January of 2002 and December of 2002 , patients with large defects who underwent Integra grafting for reconstruction were r and omly divided into groups receiving either a new treatment with fibrin glue-anchored Integra and postoperative negative-pressure therapy or conventional treatment . Demographic features , cause of the wound , location of the wound , take rate , complications of Integra coverage , time from Integra coverage to skin transplantation , and functional and aesthetic results were assessed . Twelve patients ( with similar group distributions with respect to sex , age , and location and cause of the injury ) were included in the study . The take rate was 78 ± 8 percent in the conventional treatment group and 98 ± 2 percent in the fibrin/negative-pressure therapy group ( p < 0.003 ) . The mean period from Integra coverage to skin transplantation was 24 ± 3 days in the conventional treatment group but only 10 ± 1 days in the fibrin/negative-pressure therapy group ( p < 0.002 ) . The decrease in the interval between coverage with Integra and skin transplantation result ed in shorter hospital stays . The use of fibrin glue and negative-pressure therapy in combination with Integra could shorten the period from coverage to integration , which would be beneficial in terms of decreased risks of infection , thrombosis , and catabolism . Therefore , it is suggested that Integra be used in combination with fibrin glue and negative-pressure therapy to improve clinical outcomes and shorten hospital stays , with decreased risks of accompanying complications Background : Vacuum-assisted closure therapy is a relatively new concept described in the literature that increases wound-healing capacity . The authors aim ed to investigate the effect of vacuum-assisted closure therapy on wound healing , granulation tissue formation , bacterial clearance , pain , time involvement of the staff , and total costs in all types of wounds in comparison with modern wound dressings . Methods : Sixty-five patients with a chronic or acute wound were r and omized to initial treatment with vacuum-assisted closure or modern dressings . The authors ’ primary endpoint was a granulated wound or a wound ready for skin grafting or healing by secondary intention . Results : The time to the primary endpoint with vacuum-assisted closure therapy was not significantly shorter , except for patients with cardiovascular disease and /or diabetics . Vacuum-assisted closure therapy did not result in significantly faster granulation or wound surface reduction or better bacterial clearance , but patient comfort was an important advantage . Time involvement and costs of nursing staff were significantly lower for the vacuum-assisted closure therapy , but overall costs were similar for both groups . Conclusions : With vacuum-assisted closure therapy , wound healing is at least as fast as with modern wound dressings . Especially cardiovascular and diabetic patients benefit from this therapy . The total costs of vacuum-assisted closure are comparable to those of modern wound dressings , but the advantage is its comfort for patients and nursing staff Vacuum-assisted closure has become a new technique in the challenging management of contaminated , acute , and chronic wounds . Although promising clinical results have been described , scientific proof to substantiate the mechanism of action of this therapy is scarce . In the present study , we examined whether the positive effect on wound healing found in vacuum-assisted closure-treated wounds could be explained by an effect on the bacterial load . Fifty-four patients who needed open wound management before surgical closure were included in this study . Wounds were r and omized to either vacuum-assisted closure therapy ( n= 29 ) or treatment by conventional moist gauze therapy ( n= 25 ) . Healing was characterized by development of a clean granulating wound bed ( " ready for surgical therapy " ) and reduction of wound surface area . To quantify bacterial load , biopsies were collected . No significant difference was found in time needed to reach " ready for surgical therapy " comparing both therapies . Wound surface area reduction was significantly larger in vacuum-assisted closure-treated wounds : 3.8 + /- 0.5 percent/day ( mean + /- SEM ) compared to conventional-treated wounds ( 1.7 + /- 0.6 percent/day ; p < 0.05 ) . The total quantitative bacterial load was generally stable in both therapies . However , nonfermentative gram negative bacilli showed a significant decrease in vacuum-assisted closure-treated wounds ( p < 0.05 ) , whereas Staphylococcus aureus showed a significant increase in vacuum-assisted closure-treated wounds ( p < 0.05 ) . In conclusion , this study shows a positive effect of vacuum-assisted closure therapy on wound healing , expressed as a significant reduction of wound surface area . However , this could not be explained by a significant quantitative reduction of the bacterial load OBJECTIVE Topical negative pressure ( TNP ) ( vacuum therapy ) is frequently used in the management of acute , traumatic , infected and chronic full-thickness wounds . This prospect i ve clinical r and omised trial compared the costs of TNP with conventional therapy ( moist gauze ) in the management of full-thickness wounds that required surgical closure . METHOD The direct medical costs of the total number of re sources needed to achieve a healthy , granulating wound bed that was ' ready for surgical therapy ' were calculated . RESULTS Fifty-four patients admitted to a department of plastic and reconstructive surgery were recruited into the trial . Cost analysis showed significantly higher mean material expenses for wounds treated with TNP ( 414euros+/-229euros [ SD ] ) compared with conventional therapy ( 15euros+/-11euros ; p<0.0001 ) , but significantly lower mean nursing expenses ( 33euros+/-31 euros and 83euros+/-58euros forTNP and conventional therapy respectively ; p<0.0001 ) . Hospitalisation costs were lower in theTNP group ( 1788euros+/-1060euros ) than in the conventional treatment group ( 2467euros+/-1336euros ; p<0.043 ) due to an on average shorter duration until they were'ready for surgical therapy ' . There was no significant difference in total costs per patient between the two therapies ( 2235euros+/-1301euros for TNP versus 2565euros+/-1384euros for conventional therapy ) . CONCLUSION TNP had higher material costs . However , these were compensated by the lower number of time-consuming dressing changes and the shorter duration until they were ' ready for surgical therapy ' , result ing in the therapy being equally as expensive as conventional moist gauze . DECLARATION OF INTEREST This work was partly supported by the Plastic and Reconstructive Surgery Esser Foundation , and KCI Medical , Houten , The Netherl and s. The authors have no conflicts of interest Topical negative pressure has been demonstrated to improve graft take in a number of noncomparative studies . This study aim ed to assess whether split-thickness skin graft take is improved qualitatively or quantitatively with topical negative pressure therapy compared with st and ard bolster dressings . A blinded , prospect i ve , r and omized trial was conducted of 22 adult in patients of Liverpool Hospital between July of 2001 and July of 2002 who had wounds requiring skin grafting . After grafting , each wound half was r and omized to receive either a st and ard bolster dressing or a topical negative pressure dressing . Skin graft assessment was performed at 2 weeks by a single observer blinded to the r and omization . Two patients were lost to follow-up and were excluded from the study . There were 20 patients ( 12 men and eight women ) in the study group . The median patient age was 64 years ( range , 27 to 88 years ) , and the mean wound size was 128 cm2 ( range , 35 to 450 cm2 ) . The wound exposed subcutaneous fat in eight patients , muscle in six patients , paratenon in four patients , and deep fascia in two patients . At 2 weeks , wounds that received a topical negative pressure dressing had a greater degree of epithelialization in six cases ( 30 percent ) , the same degree of epithelialization in nine cases ( 45 percent ) , and less epithelialization in five cases ( 25 percent ) compared with their respective control wounds . Graft quality following topical negative pressure therapy was subjectively determined to be better in 10 cases ( 50 percent ) , equivalent in seven cases ( 35 percent ) , and worse in three cases ( 15 percent ) . Although the quantitative graft take was not significant , the qualitative graft take was found to be significantly better with the use of topical negative pressure therapy ( p < 0.05 ) . Topical negative pressure significantly improved the qualitative appearance of split-thickness skin grafts as compared with st and ard bolster dressings Objectives : To evaluate the impact of negative pressure wound therapy ( NPWT ) after severe open fractures on deep infection . Design : Prospect i ve r and omized study . Setting : Academic level I trauma center . Patients / Participants : Fifty-nine patients with 63 severe high-energy open fractures were enrolled in this study , with data available on 58 patients with 62 open fractures . Intervention : Twenty-three patients with 25 fractures r and omized to the control group and underwent initial irrigation and debridement followed by st and ard fine mesh gauze dressing , with repeat irrigation and debridement every 48 - 72 hours until wound closure . Thirty-five patients r and omized to the NPWT group and had identical treatment except that NPWT was applied to the wounds between irrigation and debridement procedures until closure . Main Outcome Measurements : The presence or absence of deep wound infection or osteomyelitis , wound dehiscence , and fracture union were primary outcome measures . Results and Conclusions : Control patients developed 2 acute infections ( 8 % ) and 5 delayed infections ( 20 % ) , for a total of 7 deep infections ( 28 % ) , whereas NPWT patients developed 0 acute infections , 2 delayed infections ( 5.4 % ) , for a total of 2 deep infections ( 5.4 % ) . There is a significant difference between the groups for total infections ( P = 0.024 ) . The relative risk ratio is 0.199 ( 95 % confidence interval : 0.045 - 0.874 ) , suggesting that patients treated with NPWT were only one-fifth as likely to have an infection compared with patients r and omized to the control group . NPWT represents a promising new therapy for severe open fractures after high-energy trauma Objectives : To investigate negative pressure wound therapy ( NPWT ) to prevent wound dehiscence and infection after high-risk lower extremity trauma . Design : Prospect i ve r and omized multicenter clinical trial . Setting : Four Level I trauma centers . Patients / Participants : Blunt trauma patients with one of three high-risk fracture types ( tibial plateau , pilon , calcaneus ) requiring surgical stabilization . Intervention : Incisional NPWT ( Group B ) was applied to the closed surgical incisions of patients r and omized to the study arm of this trial , whereas st and ard postoperative dressings ( Group A ) were applied to the control patients . Main Outcome Measures : Acute and chronic wound dehiscence and infection . Results : Two hundred forty-nine patients with 263 fractures have enrolled in this study with 122 r and omized to Group A ( controls ) and 141 to Group B ( NPWT ) . There was no difference between the groups in the distribution of calcaneus ( 39 % ) , pilon ( 17 % ) , or tibial plateau ( 44 % ) fractures . There were a total of 23 infections in Group A and 14 in Group B , which represented a significant difference in favor of NPWT ( P = 0.049 ) . The relative risk of developing an infection was 1.9 times higher in control patients than in patients treated with NPWT ( 95 % confidence interval , 1.03–3.55 ) . Conclusions : There have been no studies evaluating incisional NPWT as a prophylactic treatment to prevent infection and wound dehiscence of high-risk surgical incisions . Our data demonstrate that there is a decreased incidence of wound dehiscence and total infections after high-risk fractures when patients have NPWT applied to their surgical incisions after closure . There is also a strong trend for decreases in acute infections after NPWT . Based on our data in this multicenter prospect i ve r and omized clinical trial , NPWT should be considered for high-risk wounds after severe skeletal trauma INTRODUCTION Open tibial fractures are associated with a high incidence of mainly osteomyelitis . Negative pressure wound therapy ( NPWT ) is a novel form of treatment that uses subatmospheric pressure to effect early wound healing . OBJECTIVES AND STUDY DESIGN To determine the effect of NPWT on incidence of deep infections/osteomyelitis after open tibial fractures using a prospect i ve r and omized study design . MATERIAL S AND METHODS Ninety-three open tibial f
Output:
| There is moderate-certainty evidence for no clear difference between NPWT and st and ard care on the proportion of wounds healed at six weeks for open fracture wounds .
There is moderate-certainty evidence that NPWT is not a cost-effective treatment for open fracture wounds .
It is uncertain whether there is a difference in risk of wound infection , adverse events , time to closure or coverage surgery , pain or health-related quality of life between NPWT and st and ard care for any type of open traumatic wound |
MS213153 | ***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 African American men with hypertension in low socioeconomic urban population s achieve poor rates of hypertension control and suffer early from its complications . METHODS In a r and omized clinical trial with 309 hypertensive urban African American men aged 21 to 54 years , we evaluated the effectiveness of a more intensive comprehensive educational-behavioral-pharmacologic intervention by a nurse practitioner-community health worker-physician ( NP/CHW/MD ) team and a less intensive education and referral intervention in controlling blood pressure ( BP ) and minimizing progression of left ventricular hypertrophy ( LVH ) and renal insufficiency . Changes in BP , left ventricular mass ( LVM ) , and serum creatinine from baseline to 36 months were compared between groups . RESULTS At 36 months , the mean systolic BP/diastolic BP change from baseline was -7.5/-10.1 mm Hg for the more intensive group and + 3.4/-3.7 mm Hg for the less intensive group ( P = .001 and .005 for between-group differences in systolic BP and diastolic BP , respectively ) . The proportion of men with controlled BP ( < 140/90 mm Hg ) was 44 % in the more intensive group and 31 % in the less intensive group ( P = .045 ) . The LVM was significantly lower in the more intensive group than in the less intensive group ( more intensive , 274 g ; less intensive , 311 g ; P = .004 ) . There was a trend toward slowing of the progression of renal insufficiency ( incidence of 50 % increase in serum creatinine ) in the more intensive group compared to the less intensive group ( more intensive , 5.2 % ; less intensive , 8.0 % ; P = .08 ) . CONCLUSIONS During 36 months , the more intensive intervention led to a lower BP and decreased progression of LVH in a sample of hypertensive young African American men Coronary atherosclerotic disease remains the leading cause of death in the United States despite a considerable decrease in mortality rates since the 1980s ( 1 ) . This decrease in the rate of death from ischemic heart disease is attributable in part to the now-established technologies of invasive cardiac procedures : cardiac catheterization , percutaneous transluminal coronary angioplasty , and coronary artery bypass grafting ( 2 ) . Unfortunately , as with many health indicators and health services , improvements in both the mortality rate from coronary disease and rates of invasive cardiac procedures among black persons have lagged behind those of white persons ( 1 , 3 - 10 ) . Although previous work documented ethnic differences in use of cardiac procedures , the studies were limited by cross-sectional design , examination of a few selected practice setting s , or exclusion of potentially confounding clinical and socioeconomic variables ( 11 - 24 ) . Furthermore , previous research has not addressed whether or which factors can alter trends in use of cardiac procedures and thus narrow disparity among ethnic groups . We hypothesized that the large variation in use of cardiac procedures between black persons and white persons would decrease with acquisition of adequate health insurance when this occurs in conjunction with development of a serious illness . Increased use of cardiac procedures among black persons may follow attainment of health insurance or establishment of a regular source of medical care . Once serious illness occurs , avoidance of discretionary procedures because of increased risk for complications may lead to a relative decrease in use of procedures among white persons , especially if procedures were previously overused . End-stage renal disease ( ESRD ) is a significant illness in which patients are at high risk for cardiovascular disease ; patients with ESRD almost always acquire Medicare health insurance and enter a comprehensive system of care . Cross-sectional research suggests that access to dialysis and physician visits improved after enactment of the Medicare program ( 25 , 26 ) . We used the progression of patients from chronic renal failure to ESRD as a natural experiment to examine whether ethnic differences in use of cardiovascular procedures narrow with initiation of long-term dialysis and coincident acquisition of insurance . Methods Study Design and Patients We performed a national longitudinal cohort study in patients with chronic renal failure and ascertained use of cardiovascular procedures before ( baseline ) and after ( follow-up ) development of ESRD . To be eligible for inclusion in the study , patients had to have new-onset ESRD in 1986 or 1987 , be either black or white , and be at least 18 years of age . We followed patients for up to 7 years : until death , renal transplantation , or the end of the study on 31 December 1992 . Data Collection We used data from the Case Mix Severity Study of the United States Renal Data System ( USRDS ) . The USRDS is a national research organization created and funded by the National Institutes of Health to assemble information on ESRD incidence , prevalence , treatment , morbidity , and mortality . The primary purpose of the Case Mix Severity Study , conducted from 1989 to 1991 , was to provide prevalence data on the frequency of various comorbid conditions that commonly occur in ESRD . The Case Mix Severity Study used a two-stage r and om sampling method of patients and dialysis units to obtain a 5 % national r and om sample of patients with incident ESRD in 1986 to 1987 ( 27 ) . Abstract ers review ed medical charts in dialysis units to identify patients ' clinical and socioeconomic status by using a st and ardized instrument that recorded information obtained shortly before development of ESRD and initiation of dialysis . Variables included information about health insurance , education , marital status , employment status , type of employment , medical history of coronary disease , coronary risk factors , comorbid conditions , and physical examination and laboratory data . Data on medical evidence of ESRD , as part of the USRDS , provided baseline sociodemographic information on date of birth , sex , ethnic group , and date of ESRD onset . For data sources in the 7-year follow-up period after the onset of ESRD , we used Medicare hospitalization records that provided the date of admission , date of discharge , and procedure and diagnosis codes for each hospitalization . Medicare registry data provided the date s of renal transplant or death . Consequently , we could identify patient admissions at any acute care hospital in the United States over the course of the study and link medical record abstract ion data to Medicare registry and hospitalization files . Medicare hospitalization and registry data were assembled 3 years after the end of follow-up to provide complete records . Outcome Measures For receipt of a cardiac procedure before onset of ESRD , we used evidence of cardiac catheterization , angioplasty , or coronary artery bypass grafting from medical record abstract ion . For longitudinal outcomes after the onset of ESRD and initiation of dialysis , we used the first evidence of these cardiac procedures from hospitalization records . The following codes from the International Classification of Diseases , Ninth Revision , Clinical Modification [ ICD-9-CM ] , were used : for cardiac catheterization , codes 37.21 , 37.23 , and 88.57 to 88.59 ; for angioplasty , codes 36.01 , 36.02 and 36.05 ; and for coronary artery bypass grafting , codes 36.10 to 36.19 ( 28 ) . In the primary longitudinal analysis , we did not examine patients who had already undergone a cardiac procedure at baseline because , by definition , they had already had access to a procedure . These patients were included in sensitivity analyses . For both baseline and follow-up analyses , we also separately examined receipt of diagnostic procedures ( cardiac catheterization ) and therapeutic procedures ( angioplasty and coronary artery bypass grafting ) . Furthermore , as a follow-up outcome , we examined the specific case of receipt of a cardiac procedure within 90 days after admission for a primary diagnosis of coronary artery disease ( ICD-9-CM codes 411.1 , 411.81 , 411.89 , 410 , 413 , and 414 ) or acute myocardial infa rct ion ( ICD-9-CM codes 410.x ) as a proxy measure of clinical appropriateness ( 12 , 13 , 29 ) . Statistical Analyses Primary Analysis We performed bivariate analyses with the chi-square and Student t-tests to investigate differences in baseline socioeconomic and clinical characteristics between black persons and white persons and to examine the relations between individual clinical and socioeconomic characteristics and the outcomes of receipt of a cardiac procedure at baseline and at follow-up . We then developed a logistic regression model to examine whether receipt of a cardiovascular procedure at baseline varied by ethnic group while adjusting for explanatory or potentially confounding socioeconomic and clinical variables . We constructed the model with covariates that were significantly associated with receipt of a cardiac procedure in bivariate analyses or variables that were deemed clinical ly relevant for the analyses . Our explanatory demographic and socioeconomic variables were age , ethnic group , sex , type of health insurance at baseline ( private , Medicaid , Medicare , or no insurance ) , education ( high school graduate ) , type of employment ( white collar , blue collar , or other ) , employment status ( employed , retired or disabled , or unemployed ) , marital status ( single , married , or previously married ) , and region of the United States ( northeast , southeast , midwest , west , or southwest ) . Clinical variables were coronary artery disease ( history of myocardial infa rct ion or angina ) , hypertension ( Fifth Joint National Committee on Hypertension criteria for hypertension steps 1 and above or history of hypertension ) , history of smoking , elevated cholesterol level ( > 5.2 mmol/L [ > 200 mg/dL ] ) , elevated triglyceride level ( > 2.8 mmol/L [ > 2.5 g/L ] ) , diabetes mellitus ( history of diabetes or receiving medication for diabetes ) , obesity ( body mass index>27.8 kg/m2 for men and > 27.3 kg/m2 for women or nutritional status described as obese ) , cerebrovascular disease ( history of stroke ) , congestive heart failure ( history of congestive heart failure ) , history of a malignant condition , low serum albumin level ( < 30 g/L ) , and type of dialysis ( hemodialysis or peritoneal dialysis ) ( 30 ) . To identify receipt of a cardiovascular procedure during follow-up , we constructed a similar logistic regression model . In this model , we included adjustment for the number of days at risk for having a cardiac procedure , because black persons who receive dialysis live longer than white persons who undergo this treatment ( 31 - 33 ) . We also performed stratified subgroup analyses by year of follow-up and by insurance status at baseline ; in these analyses , we modified the models to include key but fewer variables because of the smaller number of patients in each stratum . Adding variables to these models in separate analyses did not appreciably change the point estimates . Finally , we developed a Cox proportional-hazards model to examine time to receipt of a cardiovascular procedure during follow-up for white persons compared with black persons . In addition to the explanatory variables in the other models , we included time-dependent covariates for specific comorbid diseases during follow-up in this model so that we could account not only for baseline conditions but also for conditions that may have developed after the onset of ESRD and could have decreased or increased the likelihood of an invasive cardiac procedure . For time-dependent covariates , we used evidence of hospital admission for cerebrovascular disease ( ICD-9-CM codes 430 to 438 ) , malignant conditions ( ICD-9-CM codes 140 to 172.9 , 174 to 195.8 , 196 to 199.1 , and 200 to 208.9 ) , and peripheral vascular disease ( ICD-9-CM codes 440.2 , 443.8 to 444.0 , and 444.22 to 444.81 ) . We also We tested the short-term efficacy and feasibility of two stress education approaches toe the treatment of mild hypertension in older African Americans . This was a r and omized , controlled , single-blind trial with 3 months of follow-up in primary care , inner-city health center . Of 213 African American men and women screened , 127 individuals ( aged 55 to 85 years with initial diastolic pressure of 90 to 109 mm Hg , systolic pressure of < or = 189 mm Hg , and final baseline blood pressure of < or = 179/104 mm Hg ) were selected . Of these , 16 did not complete follow-up blood pressure measurements . Mental and physical stress reduction approaches ( Transcendental Meditation and progressive muscle relaxation ) were compared with a lifestyle modification education control program and with each other . The primary outcome measures were changes in clinic diastolic and systolic pressures from baseline to final follow-up , measured by blinded observers . The secondary measures were linear blood pressure trends , changes in home blood pressure , and intervention compliance . Adjusted for significant baseline differences and compared with control , Transcendental Meditation reduced systolic pressure by 10.7 mm Hg ( P < .0003 ) and diastolic pressure by 6.4 mm Hg ( P < .00005 ) . Progressive muscle relaxation lowered systolic pressure by 4.7 mm Hg ( P = 0054 ) and diastolic pressure by 3.3 mm Hg ( P < .02 ) . The reductions in the Transcendental Meditation group were significantly greater
Output:
| On average , these health care interventions improved the quality of care for racial/ethnic minorities , improved health outcomes ( such as diabetes control and reduced diabetes complications ) , and possibly reduced health disparities in quality of care .
There is evidence supporting the use of interventions that target patients ( primarily through culturally tailored programs ) , providers ( especially through one-on-one feedback and education ) , and health systems ( particularly with nurse case managers and nurse clinicians ) . |
MS213154 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The aim of this study was to evaluate the effect of maternal use of chewing gums containing combinations of xylitol , sorbitol , chlorhexidine , and fluoride on salivary mutans streptococci ( MS ) counts and caries prevalence in the mothers ' 3-year-old children . After screening 416 women with newborn babies , 173 mothers with high counts of salivary MS were r and omly assigned into 3 experimental chewing gum groups containing ( A ) xylitol ( n=61 ) , ( B ) chlorhexidine/xylitol/sorbitol ( n=55 ) , and ( C ) sodium fluoride/xylitol/sorbitol ( n=57 ) . Mothers with low or medium MS counts formed a reference group ( D ) without any intervention ( n=232 ) . The participants in the experimental groups were instructed to chew one piece of the gum for 5 min 3 times a day . The chewing regimen started when the child was 6 months old and was terminated 1 year later . The outcome measures were salivary MS counts and caries prevalence at the age of 3 years . Bacterial enumeration was carried out with a chair-side technique and caries ( defs ) was scored by clinical examination . Medium and high counts of salivary MS were found in 13 % , 16 % , and 22 % in groups A , B , and C , respectively . The mean defs was 0.1 in group A , 0.2 in group B , and 0.4 in group C. The differences concerning salivary MS and caries were not statistically significant . The MS counts and caries prevalence in children of mothers with low MS counts ( group D ) were similar to those found in groups A and B. In conclusion , lower but non-significant levels of salivary MS and dental decay were observed in 3-year-old children to mothers who used high-content xylitol gums compared with those who used lower amounts of xylitol . The efficiency of this type of targeted intervention in a low-caries community may be question ed Background Maaori are the Indigenous people of New Zeal and and do not enjoy the same oral health status as the non-Indigenous majority . To overcome oral health disparities , the life course approach affords a valid foundation on which to develop a process that will contribute to the protection of the oral health of young infants . The key to this process is the support that could be provided to the parents or care givers of Maaori infants during the pregnancy of the mother and the early years of the child . This study seeks to determine whether implementing a kaupapa Maaori ( Maaori philosophical viewpoint ) in an early childhood caries ( ECC ) intervention reduces dental disease burden among Maaori children . The intervention consists of four approaches to prevent early childhood caries : dental care provided during pregnancy , fluoride varnish application to the teeth of children , motivational interviewing , and anticipatory guidance . Methods / design The participants are Maaori women who are expecting a child and who reside within the Maaori tribal area of Waikato-Tainui . This r and omised-control trial will be undertaken utilising the principles of kaupapa Maaori research , which encompasses Maaori leadership , Maaori relationships , Maaori customary practice s , etiquette and protocol . Participants will be monitored through clinical and self-reported information collected throughout the ECC intervention . Self-report information will be collected in a baseline question naire during pregnancy and when children are aged 24 and 36 months . Clinical oral health data will be collected during st and ardised examinations at ages 24 and 36 months by calibrated dental professionals . All participants receive the ECC intervention benefits , with the intervention delayed by 24 months for participants who are r and omised to the control-delayed arm . Discussion The development and evaluation of oral health interventions may produce evidence that supports the application of the principles of kaupapa Maaori research in the research processes . This study will assess an ECC intervention which could provide a meaningful approach for Maaori for the protection and maintenance of oral health for Maaori children and their family , thus reducing oral health disparities . Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) : ACTRN12611000111976 Background Poor oral health , such as periodontal ( gum ) disease , has been found to be associated with an increased risk of adverse pregnancy outcomes including preterm birth , low birth weight , and neonatal and infant mortality , especially in low- and middle-income countries . However , there is little or no access to preventive dental care in most low- and middle-income countries . We propose to develop and test a “ Mouth Rinse Intervention ” among pregnant women to prevent the progression of periodontal disease during pregnancy and reduce adverse birth and neonatal outcomes in a rural county of China . Methods / Design This is a r and omized controlled clinical trial . A sample of 468 ( 234 in each arm of the study ) women in early pregnancy with periodontal disease will be recruited for the study . Periodontal disease will be diagnosed through the methods of Periodontal Screening and Recording . All women diagnosed with periodontal disease will be r and omly allocated into the intervention or control group . Women assigned in the intervention group will be provided with non-alcohol antimicrobial mouth rinse containing cetylpyridinium chloride throughout the pregnancy and oral health education . Women in the control group will receive a package of tooth brush and paste , plus oral hygiene education . Women will be followed-up to childbirth until the 42nd day postpartum . The main outcomes include mean birthweight ( gram ) and mean gestational age ( week ) . Discussion Compared with conventional mechanical ‘ scaling and root planning ’ periodontal treatment during pregnancy , our proposed mouth rinse intervention could be a simple , cost-effective , and sustainable solution to improve both mother ’s oral health and neonate outcomes . If the mouth rinse is confirmed to be effective , it would demonstrate great potential for the application in other low- or middle-income countries to prevent adverse birth outcomes such as preterm birth and low birth weight and to reduce neonatal and infant mortality . Trial registration This trial was registered with Chinese Clinical Trial Registry ( ChiCTR ) : ( # ChiCTR-TRC-13003768 ) on November 06 , 2013 A long-term prospect i ve , r and omized dietary intervention to prevent exposure of children to the known atherosclerosis risk factors ( the STRIP baby project ) was started when the age of the children was 7 months . The aim of this sub study was to analyze the oral effects of the dietary intervention in the children and their parents when the children had reached the age of 3 years . Every fifth family of the main study was invited to this sub study ( n = 179 ) . Those studied ( n = 148 ) represented well the intervention and the control groups and both genders in terms of intake of saturated fatty acids , the dietary polyunsaturated fatty acid to saturated fatty acid ( PUFA/SAFA ) ration and serum cholesterol and HDL cholesterol concentrations . Though no difference was found in sucrose consumption between the intervention and the control groups , the intervention children received relatively ( in E% ) more energy from carbohydrates than the control children ( p < 0.005 ) , used absolutely ( in g ) and relatively ( in E% ) less fat ( p < 0.05 ) and had a higher PUFA/SAFA ratio in their diet ( p < 0.001 ) . Of the 3-year-old children 93 % were caries free , and dental decay was a prevalent in the intervention as in the control children . Control children brushed their teeth unassisted more often than the intervention children ( p < 0.05 ) . The intervention fathers also received more energy ( in E% ) from carbohydrates ( p < 0.01 ) , the intervention mothers used less fat ( p < 0.05 ) and had a higher PUFA/SAFA ratio in the diet ( p < 0.05 ) than the control fathers and mothers , respectively . Dental and periodontal health of the intervention and control parents ( n = 250 , 84 % attending , mean + /- SD age : 34.2 + /- 54.5 years also showed no differences even though the control parents had more commonly last visited a dentist over 3 years before this examination ( p < 0.05 ) . We conclude that a 29-month period of a low-saturated-fat , low-cholesterol but high-carbohydrate diet as advocated in the STRIP baby trial does not seem to have harmful effects on the oral health of the children or their parents . Minor untoward differences had occurred in the dental health behavior of the control children and their parents OBJECTIVE To examine the effect of a nutrition and hygiene education intervention on oral health behaviour and whether early onset of caries was related to child growth in rural Ug and a. METHODS Follow-up study of a cluster-r and omised controlled trial conducted between October 2013 and January 2015 . Data were available from 399 mother/child pairs ( 203 in the intervention and 198 in the control group ) of the original trial ( 78 % ) when the children were 36 months old . Oral health behaviour was evaluated using question naires . Photographs of the maxillary anterior teeth were examined for unmistakably carious lesions , and 115 water sample s from the study area were analysed for fluoride concentration . RESULTS The frequency of cleaning of the child 's teeth at 36 months was about twice as high in the intervention as in the control group ( 84.3 % vs. 46.6 % ; P = 0.0001 ) . Cavitated carious lesions occurred more frequently in the control than the intervention group ( 27.8 % vs. 18.2 % ; P = 0.04 ) . Extraction of ' false teeth ' ( ebiino ) , a painful and crude traditional operation , was profoundly reduced in the intervention group ( 8.9 % vs. 24.7 % ; P = 0.001 ) . There was no evidence of association between the occurrence of caries and child growth . CONCLUSIONS The education intervention improved oral hygiene practice s and reduced the development and progression of caries and extraction of ebiino . Early childhood caries was not clearly associated with child growth OBJECTIVE To investigate the impact of an integrated oral health promotion intervention , within the Syrian national immunisation programme , which provided free preventive dental health products , without health workers ' counselling , on one-year-old infants ' tooth-brushing and bottle-feeding termination practice s. RESEARCH DESIGN a r and omised controlled parallel-group trial . SETTING A maternal and child health centre in Sweida city , Syria . PARTICIPANTS 92 mothers of one-year-old infants , attending an infant vaccination clinic , were allocated into three groups : Test , Control One and Control Two . INTERVENTIONS The Test group received an oral health promotion package including an infant oral health pamphlet , a baby toothbrush , fluoride toothpaste ( 1,000 mg/L ) and a trainer cup , without health workers ' counselling . Control One received only the pamphlet , whilst Control Two received no intervention . MAIN OUTCOME MEASURES after one month , the presence of old plaque on infants ' primary teeth was checked , to assess tooth-brushing behaviour . Also , a mothers ' self-completed question naire was administered to assess bottle-feeding use . RESULTS The response rate was 100 % and the attrition rate was zero . There were differences in tooth-brushing and bottle-feeding termination practice s between the three groups ( P⟩0.001 ) . Infants in the Test group were less likely to have old plaque and more likely to stop bottle-feeding than their counterparts in the two control groups . There were no differences in the abovementioned outcomes between the two control groups . CONCLUSIONS Providing free preventive dental health products , without health worker 's counselling , in an integrated oral health promotion intervention , was an effective measure to promote infants ' tooth-brushing and bottle-feeding termination practice s. These findings should be supported by long-term follow up studies 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
Output:
| Moderate-certainty evidence suggests that providing advice on diet and feeding to pregnant women , mothers or other caregivers with children up to the age of one year probably leads to a slightly reduced risk of early childhood caries ( ECC ) . |
MS213155 | ***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: Importance Epicutaneous immunotherapy may have potential for treating peanut allergy but has been assessed only in pre clinical and early human trials . Objective To determine the optimal dose , adverse events ( AEs ) , and efficacy of a peanut patch for peanut allergy treatment . Design , Setting , and Participants Phase 2b double-blind , placebo-controlled , dose-ranging trial of a peanut patch in peanut-allergic patients ( 6 - 55 years ) from 22 centers , with a 2-year , open-label extension ( July 31 , 2012-July 31 , 2014 ; extension completed September 29 , 2016 ) . Patients ( n = 221 ) had peanut sensitivity and positive double-blind , placebo-controlled food challenges to an eliciting dose of 300 mg or less of peanut protein . Interventions R and omly assigned patients ( 1:1:1:1 ) received an epicutaneous peanut patch containing 50 & mgr;g ( n = 53 ) , 100 & mgr;g ( n = 56 ) , or 250 & mgr;g ( n = 56 ) of peanut protein or a placebo patch ( n = 56 ) . Following daily patch application for 12 months , patients underwent a double-blind , placebo-controlled food challenge to establish changes in eliciting dose . Main Outcomes and Measures The primary efficacy end point was percentage of treatment responders ( eliciting dose : ≥10-times increase and /or reaching ≥1000 mg of peanut protein ) in each group vs placebo patch after 12 months . Secondary end points included percentage of responders by age strata and treatment-emergent adverse events ( TEAEs ) . Results Of 221 patients r and omized ( median age , 11 years [ quartile 1 , quartile 3 : 8 , 16 ] ; 37.6 % female ) , 93.7 % completed the trial . A significant absolute difference in response rates was observed at month 12 between the 250-&mgr;g ( n = 28 ; 50.0 % ) and placebo ( n = 14 ; 25.0 % ) patches ( difference , 25.0 % ; 95 % CI , 7.7%-42.3 % ; P = .01 ) . No significant difference was seen between the placebo patch vs the 100-&mgr;g patch . Because of statistical testing hierarchical rules , the 50-&mgr;g patch was not compared with placebo . Interaction by age group was only significant for the 250-&mgr;g patch ( P = .04 ) . In the 6- to 11-year stratum , the response rate difference between the 250-&mgr;g ( n = 15 ; 53.6 % ) and placebo ( n = 6 ; 19.4 % ) patches was 34.2 % ( 95 % CI , 11.1%-57.3 % ; P = .008 ) ; adolescents/adults showed no difference between the 250-&mgr;g ( n = 13 ; 46.4 % ) and placebo ( n = 8 ; 32.0 % ) patches : 14.4 % ( 95 % CI , −11.6 % to 40.4 % ; P = .40 ) . No dose-related serious AEs were observed . The percentage of patients with 1 or more TEAEs ( largely local skin reactions ) was similar across all groups in year 1 : 50-&mgr;g patch = 100 % , 100-&mgr;g patch = 98.2 % , 250-&mgr;g patch = 100 % , and placebo patch = 92.9 % . The overall median adherence was 97.6 % after 1 year ; the dropout rate for treatment-related AEs was 0.9 % . Conclusions and Relevance In this dose-ranging trial of peanut-allergic patients , the 250-&mgr;g peanut patch result ed in significant treatment response vs placebo patch following 12 months of therapy . These findings warrant a phase 3 trial . Trial Registration clinical trials.gov Identifier : Background : Peanut allergy is common , life‐threatening , and without therapeutic options . We evaluated peanut epicutaneous immunotherapy ( EPIT ) by using Viaskin Peanut for peanut allergy treatment . Objective : We sought to evaluate the clinical , safety , and immunologic effects of EPIT for the treatment of peanut allergy . Methods : In this multicenter , double‐blind , r and omized , placebo‐controlled study , 74 participants with peanut allergy ( ages 4‐25 years ) were treated with placebo ( n = 25 ) , Viaskin Peanut 100 & mgr;g ( VP100 ; n = 24 ) or Viaskin Peanut 250 & mgr;g ( VP250 ; n = 25 ; DBV Technologies , Montrouge , France ) . The primary outcome was treatment success after 52 weeks , which was defined as passing a 5044‐mg protein oral food challenge or achieving a 10‐fold or greater increase in successfully consumed dose from baseline to week 52 . Adverse reactions and mechanistic changes were assessed . Results : At week 52 , treatment success was achieved in 3 ( 12 % ) placebo‐treated participants , 11 ( 46 % ) VP100 participants , and 12 ( 48 % ) VP250 participants ( P = .005 and P = .003 , respectively , compared with placebo ; VP100 vs VP250 , P = .48 ) . Median change in successfully consumed doses were 0 , 43 , and 130 mg of protein in the placebo , VP100 , and VP250 groups , respectively ( placebo vs VP100 , P = .014 ; placebo vs VP250 , P = .003 ) . Treatment success was higher among younger children ( P = .03 ; age , 4‐11 vs > 11 years ) . Overall , 14.4 % of placebo doses and 79.8 % of VP100 and VP250 doses result ed in reactions , predominantly local patch‐site and mild reactions ( P = .003 ) . Increases in peanut‐specific IgG4 levels and IgG4/IgE ratios were observed in peanut EPIT‐treated participants , along with trends toward reduced basophil activation and peanut‐specific TH2 cytokines . Conclusions : Peanut EPIT administration was safe and associated with a modest treatment response after 52 weeks , with the highest responses among younger children . This , when coupled with a high adherence and retention rate and significant changes in immune pathways , supports further investigation of this novel therapy BACKGROUND Epicutaneous allergen administration using a patch may be an alternative to subcutaneous or sublingual immunotherapy . OBJECTIVE To optimize treatment dose and to demonstrate the efficacy and safety of epicutaneous immunotherapy . METHODS This monocentric , placebo-controlled , double-blind trial included 132 patients with grass pollen-induced rhinoconjunctivitis . In February 2008 , patients were r and omly allocated to receive placebo or 3 different doses of allergen . Before and during the pollen season 2008 , patients received 6 weekly patches . Efficacy was assessed 4 to 5 months later ( n = 110 ) and during the pollen season of the treatment-free follow-up year in 2009 ( n = 93 ) . The primary outcome was patient-reported changes in hay fever symptoms assessed by a visual analog scale . Secondary outcome measures were weekly visual analog scale symptom scores during pollen season , use of rescue medication , changes in conjunctival and skin reactivity , as well as safety . RESULTS Hay fever symptoms during the pollen season were reduced by more than 30 % in 2008 and by 24 % in 2009 in the high-dose group as compared with that in the placebo group , and the alleviation of symptoms in the follow-up year was dependent on the treatment dose . Higher allergen doses were associated with drug-related adverse events ( AEs ) , predominantly manifested by pruritus , erythema , wheal , or eczema . Eleven systemic AEs of grade s 1 to 2 required treatment and led to study exclusion . The dropout rate due to AEs was 8.3 % . No drug-related serious AE was recorded . CONCLUSION Epicutaneous immunotherapy is safe and efficacious in a dose-dependent manner after 6 patches only BACKGROUND Subcutaneous allergen-specific immunotherapy is an effective treatment of IgE-mediated allergies , but it requires repeated allergen injections with a risk of systemic allergic reactions . Transcutaneous immunotherapy may improve patient compliance and safety . OBJECTIVE To assess the safety and efficacy of epicutaneous allergen immunotherapy . METHODS This monocentric , placebo-controlled , double-blind trial was conducted from March 2006 to December 2007 at the University Hospital Zurich . Thirty-seven adult patients with positive skin prick and nasal provocation tests to grass pollen were r and omized to receive patches containing either allergen ( n = 21 ) or placebo ( n = 16 ) . Treatment took place before and during the pollen season 2006 , and follow-up visits took place before ( n = 26 ) and after the pollen season 2007 ( n = 30 ) . The primary outcome measures were nasal provocation tests . RESULTS Allergen-treated patients showed significantly decreased scores in nasal provocation tests in the first ( P < .001 ) and second year ( P = .003 ) after treatment . In contrast , placebo-treated patients had decreased scores in the first treatment year , 2006 ( P = .03 ) , but the effect diminished in the second year ( P = .53 ) . Although improvement of nasal provocation test scores was not significantly better in the verum versus placebo group , the overall treatment success was rated significantly higher by the allergen-treated group than by the placebo group ( 2006 , P = .02 ; 2007 , P = .005 ) . No severe adverse events were observed . Occurrence of eczema after allergen patch applications proved stimulation of specific T-cell responses , but was noted as an adverse effect of the treatment . CONCLUSION Epicutaneous allergen immunotherapy is a promising strategy to treat allergies and merits further investigation Importance There are currently no approved treatments for peanut allergy . Objective To assess the efficacy and adverse events of epicutaneous immunotherapy with a peanut patch among peanut-allergic children . Design , Setting , and Participants Phase 3 , r and omized , double-blind , placebo-controlled trial conducted at 31 sites in 5 countries between January 8 , 2016 , and August 18 , 2017 . Participants included peanut-allergic children ( aged 4 - 11 years [ n = 356 ] without a history of a severe anaphylactic reaction ) developing objective symptoms during a double-blind , placebo-controlled food challenge at an eliciting dose of 300 mg or less of peanut protein . Interventions Daily treatment with peanut patch containing either 250 & mgr;g of peanut protein ( n = 238 ) or placebo ( n = 118 ) for 12 months . Main Outcomes and Measures The primary outcome was the percentage difference in responders between the peanut patch and placebo patch based on eliciting dose ( highest dose at which objective signs/symptoms of an immediate hypersensitivity reaction developed ) determined by food challenges at baseline and month 12 . Participants with baseline eliciting dose of 10 mg or less were responders if the posttreatment eliciting dose was 300 mg or more ; participants with baseline eliciting dose greater than 10 to 300 mg were responders if the posttreatment eliciting dose was 1000 mg or more . A threshold of 15 % or more on the lower bound of a 95 % CI around responder rate difference was prespecified to determine a positive trial result . Adverse event evaluation included collection of treatment-emergent adverse events ( TEAEs ) . Results Among 356 participants r and omized ( median age , 7 years ; 61.2 % male ) , 89.9 % completed the trial ; the mean treatment adherence was 98.5 % . The responder rate was 35.3 % with peanut-patch treatment vs 13.6 % with placebo ( difference , 21.7 % [ 95 % CI , 12.4%-29.8 % ; P < .001 ] ) . The prespecified lower bound of the CI threshold was not met . TEAEs , primarily patch application site reactions , occurred in 95.4 % and 89 % of active and placebo groups , respectively . The all-causes rate of discontinuation was 10.5 % in the peanut-patch group vs 9.3 % in the placebo group . Conclusions and Relevance Among peanut-allergic children aged 4 to 11 years , the percentage difference in responders at 12 months with the 250-&mgr;g peanut-patch therapy vs placebo was 21.7 % and was statistically significant , but did not meet the prespecified lower bound of the confidence interval criterion for a positive trial result . The clinical relevance of not meeting this lower bound of the
Output:
| Conclusion : The systematic review suggests that EPIT might induce desensitization in peanut allergy and an increased risk of local AEs . |
MS213156 | ***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: STATEMENT OF PROBLEM Treatment of tooth loss in the anterior maxilla can involve difficult functional , esthetic , and psychologic problems , especially in young patients with otherwise good dentition . PURPOSE The purpose of this study was to provide a preliminary comparative evaluation of two implants ( ITI and Astra ) in single-tooth restorations . MATERIAL AND METHODS This prospect i ve study of 102 single-tooth replacements with 56 ITI and 46 Astra dental implants was performed in 82 patients at the Finnish Student Health Service Foundation . One Astra implant was lost before loading . The overall survival rate of the implants was 97.8 % for Astra implants and 100 % for the ITI system . After the initial healing period of at least 6 months , the remaining 101 implants ( 56 ITI , 45 Astra ) were free of periimplant infection and revealed no detectable mobility . Radiographs did not reveal signs of periimplant radiolucencies . All 101 implants received single-tooth crowns . RESULTS Periimplant parameters and acceptable implant function were examined and demonstrated satisfactory results with preestablished clinical parameters and radiographs at 1 year . During the observation time the mean marginal bone loss was 0.13 mm with Astra implants and 0.11 mm with ITI implants . Subjectively all patients were satisfied with their single-tooth restorations supported by either ITI or Astra dental implants . CONCLUSION The favorable results of this short-term study support the application of the two implant systems for single-tooth restorations , especially in the anterior region of the maxilla PURPOSE To evaluate the influence of macro- and microstructure of the implant surface at the marginal bone level after functional loading . MATERIAL S AND METHODS Sixty-eight patients were r and omly assigned to 1 of 3 groups . The first group received 35 implants with a machined neck ( Ankylos ) ; the second group , 34 implants with a rough-surfaced neck ( Stage 1 ) ; and the third , 38 implants with a rough-surfaced neck with microthreads ( Oneplant ) . Clinical and radiographic examinations were conducted at baseline ( implant loading ) and 3 , 6 , and 12 months postloading . Two-way repeated analysis of variance ( ANOVA ) was used to test the significance of marginal bone change of each tested group at baseline , 3 , 6 , and 12 month follow-ups and 1-way ANOVA was also used to compare the bone loss of each time interval within the same implant group ( P < .05 ) . RESULTS At 12 months , significant differences were noted in the amount of alveolar bone loss recorded for the 3 groups ( P < .05 ) . The group with the rough-surfaced microthreaded neck had a mean crestal bone loss of 0.18 + /- 0.16 mm ; the group with the rough-surfaced neck , 0.76 + /- 0.21 mm ; and the group with the machined neck , 1.32 + /- 0.27 mm . In the rough-surfaced group and the rough-surfaced microthreaded group , no statistically significant changes were observed after 3 months , whereas the machined-surface group showed significant bone loss for every interval ( P < .05 ) . DISCUSSION To minimize marginal bone loss , in addition to the use of a rough surface at the marginal bone level , a macroscopic modification such as the addition of microthreads could be recommended . A rough surface and microthreads at the implant neck not only reduce crestal bone loss but also help with early biomechanical adaptation against loading in comparison to the machined neck design . CONCLUSION A rough surface with microthreads at the implant neck was the most effective design to maintain the marginal bone level against functional loading BACKGROUND Brånemark fixtures were originally placed in two stages , whereas titanium plasma-sprayed ( TPS ) solid-screws are placed in one stage . Long-term survival rates for both types of implants are excellent . Excellent survival rates have also been reported for machined screw-shaped ( MS ) titanium implants placed in one stage . A small number of studies have compared different implant systems and methods of implant placement . PURPOSE The purpose of this study is to report clinical outcomes from a prospect i ve longitudinal , multicenter study comparing Brånemark MS fixtures ( Nobel Biocare , Yorba Linda , California , USA ) placed in either one or two stages with a one-stage TPS system ( ITI Straumann , Waldenburg , Switzerl and ) . METHODS A protocol was design ed to compare implant survival rates , changes in crestal bone for titanium MS fixtures placed in one and two stages , and plasma-sprayed solid-screw fixtures placed in one surgical stage . Twenty-nine patients ranging in age from 24 to 82 years received MS fixtures in one stage . The average age for males was 58 years ( n = 11 ) , whereas the ages for females ( n = 18 ) ranged from 15 to 84 years ( average 58 years ) . Twenty-nine patients received machined titanium fixtures placed in two stages . There were 20 females ranging in age from 23 to 74 years ( average 54 years ) and 9 females ranging from 24 to 74 years ( average 46 years ) . Twenty-five patients received TPS fixtures . There were 15 males , ranging in age from 57 to 79 ( average 70 ) , and 10 females , ranging in age from 40 to 83 years ( average 62 years ) . Bone quality and quantity were determined from radiographs and during site preparation . Patient age , sex , location of implant placement according to jaw , length of fixtures , and number of lost fixtures were entered onto computer code sheets and continuously entered into a locked computer system . For one- and two-stage MS fixtures , nonst and ardized periapical radiographs were taken at abutment connection and follow-up . Solid screws were x-rayed at prostheses connection and follow-up . The average time between implant restoration and radiographic follow-up was 15 months . The x-rays were scanned into a computer , and a program design ed to measure radiographs was used to determine changes in crestal bone . Measurements for one- and two-stage MS fixtures were made from the top of the implant shoulder to the first bone to implant contact mesial and distally . Plasma-sprayed screws were measured from the bottom of the implant to the coronal most bone to implant contacts mesial and distally . Mesial-distal radiographic measurements were averaged and changes were compared using the t-test for related sample s. RESULTS This report presents data from the 2- to 3-year follow-up examinations . Twenty-nine patients received 80 one-stage MS fixtures . Between 0 and 1 year , two fixtures were lost , result ing in a 97.5 % cumulative survival rate ( CSR ) . The CSR remained unchanged through the 2- to 3-year follow-up . Twenty-eight patients received 78 two-stage MS fixtures . One implant was lost prior to loading and two were lost between 0- and 1-year follow-up , yielding a 96.2 % CSR at the end of 1 year . The CSR remained unchanged through the 2- to 3-year follow-up . Twenty-three patients received 78 solid-screw plasma-sprayed screws . One implant was lost prior to loading and one between the 0- to 1-year follow-up , accounting for a 97.4 % CSR at the 2- to 3-year follow-up . Changes in bone crest measurements for one-stage titanium threaded fixtures were insignificant ( -0.11 mm , p = .08 , maxillary ; 0.07 mm , p = .42 , m and ibular ) . For two-stage MS fixtures , crestal bone loss was insignificant in maxillae ( -0.16 mm , p = .92 ) and significant in m and ibles ( -0.43 mm , p = .000 ) . There was significant bone loss for TPS implants in maxillae and m and ibles ( maxillae , 1.31 mm , p = .04 ; m and ibles , 0.98 mm , p = .000 ) . CONCLUSIONS Cumulative survival rates for MS fixtures placed in one and two stages as well as one-stage TPS screws up to the 2- to 3-year follow-up examination were similar , indicating excellent clinical results . Radiographic measurements for changes in crestal bone loss were clinical ly insignificant for fixtures placed in one stage . For two-stage fixtures , maxillary changes were insignificant , whereas m and ibular bone loss was statistically significant but clinical ly insignificant . Changes in crestal bone loss for TPS implants were statistically significant BACKGROUND Interest in the use of one-stage surgery and immediate loading of oral implants has lately been increasing . PURPOSE The aim of this study was to compare the 3-year results of one-stage surgery versus two-stage surgery , early loading versus loading after a 3-month healing period , and the use of one-piece implants versus the use of two-piece implants . MATERIAL S AND METHODS The study included 108 patients with edentulous m and ibles . Each patient was treated with four Brånemark System implants ( Nobel Biocare AB , Göteborg , Sweden ) and with full fixed prostheses . Patients were consecutively treated and were distributed in four groups : group A ( one-stage surgery ) , group B ( control group with two-stage surgery ) , group C ( one-piece implants ) , and group D ( early loading ) . In groups A and B Brånemark St and ard implants and st and ard abutments were used . In group C the conical one-piece Brånemark implant was used , and in group D the patients had Brånemark System Mk III implants together with multiunit abutments . All patients were observed for 3 years . RESULTS Of the 432 inserted implants , 24 were lost . Survival rates in the three experimental groups ranged from 93.2 to 93.3 % whereas the survival rate in group B ( the control group with two-stage surgery ) was 97.5 % . The differences between the groups were not statistically significant . The changes in marginal bone level were measured from fixture insertion to the final follow-up at 3 years . The bone loss in group D ( early loading ) was significantly less than in group B ( the control group ) whereas there were no differences in marginal bone change between the other groups . CONCLUSIONS Early loading seemed to give good results in the anterior part of the m and ible . The survival rate of the early-loaded implants did not significantly differ from that of implants inserted with the conventional two-stage procedure , but the mean marginal bone loss around the surviving implants was less with early loading BACKGROUND Many longitudinal studies of different implant systems have been published but few controlled r and omized investigations have been reported . A 1-year report of a comparative study of ITI Dental Implant System implants ( Straumann AG , Waldenburg , Switzerl and ) and Brånemark System implants ( Nobel Biocare AB , Gothenburg , Sweden ) has been published by the present authors . This paper is a 3-year follow-up of that r and omized study . PURPOSE The aim of the study was to compare the outcome of fixed partial prostheses supported by ITI or Brånemark implants . The outcome was evaluated primarily in terms of survival rates and changes in marginal bone level . MATERIAL AND METHODS The study group comprised 28 patients with anterior residual dentition in the maxilla . The patients were provided with two to four implants on each side of the dentition and were r and omly allocated to Brånemark implants or ITI implants ; 77 ITI implants and 73 Brånemark implants were inserted . After 6 months abutment connections were made to both ITI and Brånemark implants . All patients were provided with fixed partial prostheses of gold-ceramic . The patients were followed up annually with clinical and radiographic examinations for 3 years RESULTS Two Brånemark implants and two ITI implants were lost . The Brånemark implants were lost before loading whereas the ITI implants were lost because of periimplantitis . The survival rate for both groups was 97.3 % . The mean marginal bone level of the Brånemark implants was situated 1.8 mm from the reference point at both the baseline and the 3-year examinations . The corresponding values for the ITI implants were 1.4 mm at baseline and 1.3 mm after 3 years . There was no significant difference between the implant systems with regard to bone level or bone level change . A steady state of the marginal bone level was calculated to have been reached after 3 years for 95.5 % of the Brånemark implants and 87.1 % of the ITI implants . Periimplantitis ( infection including pus and bone loss ) was observed with seven ITI implants but with none of the Brånemark implants . This difference was statistically significant . CONCLUSIONS No statistically significant differences were found between the implants studied , except for the frequency of periimplantitis , which was higher for the ITI implants . The survival rates were high , and the marginal bone loss was small for both systems In the present multi-center study , non-submerged ITI implants were prospect ively followed to evaluate their long-term prognosis in fully and partially edentulous patients . In a total of 1003 patients , 2359 implants were consecutively inserted . Following a healing period of 3 - 6 months , the successfully integrated implants were restored with 393 removable and 758 fixed restorations . Subsequently , all consecutive implants were documented annually up to
Output:
| No statistically significant differences in bone loss and survival rates were detected between BL and TL dental implants over a short-term observation period ( 1 to 3 years ) .
Thus , both implant systems fulfill the requirements for the replacement of missing teeth in implant dentistry |
MS213157 | ***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 aims of the present study were to compare the effects of 1 ) training at 90 and 100 % sprint velocity and 2 ) supervised versus unsupervised sprint training on soccer-specific physical performance in junior soccer players . Young , male soccer players ( 17 ±1 yr , 71 ±10 kg , 180 ±6 cm ) were r and omly assigned to four different treatment conditions over a 7-week intervention period . A control group ( CON , n=9 ) completed regular soccer training according to their teams ’ original training plans . Three training groups performed a weekly repeated-sprint training session in addition to their regular soccer training sessions performed at A ) 100 % intensity without supervision ( 100UNSUP , n=13 ) , B ) 90 % of maximal sprint velocity with supervision ( 90SUP , n=10 ) or C ) 90 % of maximal sprint velocity without supervision ( 90UNSUP , n=13 ) . Repetitions x distance for the sprint-training sessions were 15x20 m for 100UNSUP and 30x20 m for 90SUP and 90UNSUP . Single-sprint performance ( best time from 15x20 m sprints ) , repeated-sprint performance ( mean time over 15x20 m sprints ) , countermovement jump and Yo-Yo Intermittent Recovery Level 1 ( Yo-Yo IR1 ) were assessed during pre-training and post-training tests . No significant differences in performance outcomes were observed across groups . 90SUP improved Yo-Yo IR1 by a moderate margin compared to controls , while all other effect magnitudes were trivial or small . In conclusion , neither weekly sprint training at 90 or 100 % velocity , nor supervised sprint training enhanced soccer-specific physical performance in junior soccer players The aim of this study was to compare the effects of high-intensity aerobic interval and repeated-sprint ability ( RSA ) training on aerobic and anaerobic physiological variables in male football players . Forty-two participants were r and omly assigned to either the interval training group ( ITG , 4 x 4 min running at 90 - 95 % of HRmax ; n = 21 ) or repeated-sprint training group ( RSG , 3 x 6 maximal shuttle sprints of 40 m ; n = 21 ) . The following outcomes were measured at baseline and after 7 weeks of training : maximum oxygen uptake , respiratory compensation point , football-specific endurance ( Yo-Yo Intermittent Recovery Test , YYIRT ) , 10-m sprint time , jump height and power , and RSA . Significant group x time interaction was found for YYIRT ( p = 0.003 ) with RSG showing greater improvement ( from 1917 + /- 439 to 2455 + /- 488 m ) than ITG ( from 1846 + /- 329 to 2077 + /- 300 m ) . Similarly , a significant interaction was found in RSA mean time ( p = 0.006 ) with only the RSG group showing an improvement after training ( from 7.53 + /- 0.21 to 7.37 + /- 0.17 s ) . No other group x time interactions were found . Significant pre-post changes were found for absolute and relative maximum oxygen uptake and respiratory compensation point ( p < 0.05 ) . These findings suggest that the RSA training protocol used in this study can be an effective training strategy for inducing aerobic and football-specific training adaptations The purpose of this study was to compare the physiologic effects of a program of combined running and weight training ( RUN-CWT ) with a program of circuit weight training ( CWT ) . Thirty-six females ( X age = 35.7 yr ) and 41 males ( X age = 36.1 yr ) were r and omly assigned to RUN-CWT , CWT , and control groups . The training groups participated in 12-wk programs , 3 d . wk-1 . Three circuits of 10 weight-training exercises were completed with 12 - 15 repetitions performed in 30 s at 40 % of one-repetition maximum at each station . The 30-min RUN-CWT program included 30 s of running on an indoor track following each CWT station , whereas the 22.5 min CWT program included a 15-s rest period between stations . The RUN-CWT groups had a significant ( + 17 % ) increase in VO2max ( females 30.5 - 35.7 ml . kg-1 . min-1 and males 39.7 - 46.3 ml . kg-1 . min-1 ) and strength ( females + 24 % and males + 21 % ) , and a significant decrease in body fat percentage ( females -3.2 % and males -4.1 % ) . The CWT groups also increased significantly in VO2max ( + 12 % ) and strength ( + 17 % ) and decreased in body fat ( -3.0 % ) . The controls did not change significantly in any variable . Statistically , one training program was not shown to be superior to the other ; thus , both programs of RUN-CWT and CWT were effective in improving measures of physical fitness The effects of a 12-week low resistance circuit weight training ( CWT ) on cardiovascular and muscular fitness were studied in 90 healthy sedentary adults . The subjects were r and omized into three equally fit groups : CWT , Endurance ( END ) and Control ( CON ) according to their maximal aerobic power ( VO2max ) . Both training groups exercised for 12 weeks , 3 days a week in sessions of 40 min , with a heart rate ( HR ) level of 70 - 80 % HRmax . The CWT group trained with air resistance machines . Heart rate was controlled by setting the speed of movement . The END group walked , jogged , cross-country skied or cycled . The net differences ( between pre- and posttraining changes ) between the CWT and CON groups was statistically significant for VO2max ( 2.45 ml x min(-1 ) x kg(-1 ) , 95 % CI 1.1 ; 3.8 ) , for abdominal muscles ( 3.7 reps , CI 0.3 ; 7.1 ) , for push-ups ( 1.1 reps , CI 0.2 ; 2.1 ) , and for kneeling ( 2.25 reps , CI 0.01 ; 4.5 ) . The net difference ( between pre- and posttraining changes ) in the END and CON groups was statistically significant for VO2max ( 2.75 ml(-1 ) x min(-1 ) x kg(-1 ) , 95 % CI 0.9 ; 4.6 ) , and kneeling ( 3.0 reps , CI 0.7 ; 5.3 ) . Low resistance CWT with moderately hard HR level has effects comparable to an equal amount of endurance training on the cardiovascular fitness of sedentary adults . The CWT model was benefical also on muscular fitness . Based on the results , this type of exercise can be recommended for beginners because of its multilevel effects Objectives . The aim was to investigate the effects of three different types of resistance training implementation . Design . R and omized controlled trial . Methods . Inactive , overweight women ( n = 143 ) , mean BMI 31.3 ± 5.2 kg/m2 , mean age 39.9 ± 10.5 years , were r and omized to one of the following groups : A ( BodyPump group training ) , B ( individual follow-up by a personal trainer ) , C ( nonsupervised exercise ) , or D ( controls ) . The intervention included 12 weeks of 45–60 minutes ' full-body resistance training three sessions per week . The outcomes in this paper are all secondary outcome measures : exercise motivation , self-perceived health , and quality of life . Results . Adherence averaged 26.1 ± 10.3 of 36 prescribed sessions . After the intervention period , all three training groups ( A – C ) had better scores on exercise motivation ( A = 43.9 ± 19.8 , B = 47.6 ± 15.4 , C = 48.4 ± 17.8 ) compared to the control group ( D ) ( 26.5 ± 18.2 ) ( p < 0.001 ) . Groups B and C scored better on self-perceived health ( B = 1.9 ± 0.8 , C = 2.3 ± 0.8 ) , compared to group D ( 3.0 ± 0.6 ) ( p < 0.001 ) . For quality of life measurement , there was no statistically significant difference between either intervention groups or the control . Conclusions . Resistance training contributed to higher scores in important variables related to exercise motivation and self-perceived health . Low adherence showed that it was difficult to motivate previously inactive , overweight women to participate in regular strength training Thirty-five healthy men were matched and r and omly assigned to one of four training groups that performed high-intensity strength and endurance training ( C ; n = 9 ) , upper body only high-intensity strength and endurance training ( UC ; n = 9 ) , high-intensity endurance training ( E ; n = 8) , or high-intensity strength training ( ST ; n = 9 ) . The C and ST groups significantly increased one-repetition maximum strength for all exercises ( P < 0.05 ) . Only the C , UC , and E groups demonstrated significant increases in treadmill maximal oxygen consumption . The ST group showed significant increases in power output . Hormonal responses to treadmill exercise demonstrated a differential response to the different training programs , indicating that the underlying physiological milieu differed with the training program . Significant changes in muscle fiber areas were as follows : types I , IIa , and IIc increased in the ST group ; types I and IIc decreased in the E group ; type IIa increased in the C group ; and there were no changes in the UC group . Significant shifts in percentage from type IIb to type IIa were observed in all training groups , with the greatest shift in the groups in which resistance trained the thigh musculature . This investigation indicates that the combination of strength and endurance training results in an attenuation of the performance improvements and physiological adaptations typical of single-mode training The purpose of the study was to evaluate the effects of circuit training ( CT ) and treadmill exercise performed at matched rates of oxygen consumption and exercise duration on elevated post-exercise oxygen consumption ( EPOC ) in untrained women , while controlling for the menstrual cycle . Eight , untrained females ( 31.3±9.1 years ; 2.04±0.26 l min−1 estimated VO2max ; BMI = 24.6±3.9 kg/m2 ) volunteered to participate in the study . Testing was performed during the early follicular phase for each subject to minimize hormonal variability between tests . Subjects performed two exercise sessions approximately 28 days apart . Resting , supine energy expenditure was measured for 30 min preceding exercise and for 1 h after completion of exercise . Respiratory gas exchange data were collected continuously during rest and exercise periods via indirect calorimetry . CT consisted of three sets of eight common resistance exercises . Pre-exercise and exercise oxygen consumption was not different between testing days ( P>0.05 ) . Thus , exercise conditions were appropriately matched . Analysis of EPOC data revealed that CT result ed in a significantly higher ( p<0.05 ) oxygen uptake during the first 30 min of recovery ( 0.27±0.01 l min−1 vs 0.23±0.01 l min−1 ) ; though , at 60 min , treatment differences were not present . Mean VO2 remained significantly higher ( 0.231±0.01 l min−1 ) than pre-exercise measures ( 0.193±0.01 l min−1 ) throughout the 60-min EPOC period ( p<0.05 ) . Heart rate , RPE , VE and RER were all significantly greater during CT ( p<0.05 ) . When exercise VO2 and exercise duration were matched , CT was associated with a greater metabolic disturbance and cost during the early phases of EPOC Background : Aerobic training ( AT ) and circuit weight training ( CWT ) improve peak oxygen uptake ( VO2peak ) . During CWT the circulatory system is exposed to higher pressure , which could induce left ventricle morphological adaptations , possibly distinct from those derived from aerobic training . Objective : To compare the effects of aerobic training and CWT upon morphological and functional cardiac adaptations detected by magnetic resonance imaging . Methods : Twenty healthy sedentary individuals were r and omly assigned to participate in a 12-week programme of aerobic training ( n = 6 ) , CWR ( n = 7 ) or no intervention ( n = 7 , controls ) . Training programmes consisted of 36 sessions , 35 min each , 3 times per week , at 70 % of maximal heart rate , and CWT included series of resistance exercises performed at 60 % of 1 maximal repetition . Cardiopulmonary exercise testing and cardiac magnetic resonance imaging were performed before and after the intervention . Results : There was a similar improvement in VO2peak following aerobic training ( mean ( SD ) increment : 12 (4)% ) and CWT ( 12 (4)% ) , while there was no change in the control group . Aerobic training ( 12 (6)% ) and CWT ( 16 (5)% ) improved strength in the lower limbs , and only CWT result ed in improvement of 13 (4)% in the strength of the upper limbs . However , there were no detectable changes in left ventricular mass , end-diastolic volume , stroke volume or ejection fraction . Conclusion : In previously sedentary individuals , short-term CWT and aerobic training induce similar improvement in functional capacity without any adaptation in cardiac morphology detectable by cardiac magnetic resonance imaging Alcaraz , PE , Perez-Gomez , J , Chav
Output:
| Significant increases in maximum oxygen uptake and one-repetition maximum bench press were observed following resistance circuit-based training .
Conclusions The meta- analysis showed that resistance circuit-based training , independent of the protocol used in the studies , is effective in increasing maximum oxygen uptake and one-repetition maximum bench press in healthy adults .
However , its effect appears to be larger depending on the population and training characteristics .
However , the lower participant ’s baseline fitness level may explain the lighter optimal loads used in the circuit training studies where greater strength gains were reported |
MS213158 | ***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 Interferon-based hepatitis C virus ( HCV ) therapy is safe and effective among people receiving opioid substitution therapy ( OST ) , but treatment uptake remains low . Our aim was to evaluate the impact of OST and drug use during therapy on completion , adherence , sustained virologic response ( SVR12 ) , and safety of ledipasvir/sofosbuvir ± ribavirin . METHODS The phase 3 ION studies evaluated a fixed-dose combination of ledipasvir/sofosbuvir ± ribavirin administered for 8 , 12 , or 24 weeks in patients with chronic HCV genotype 1 . People with clinical ly significant drug use ( prior 12 months ) or noncannabinoids detected at screening by urine drug tests ( not explained by prescriptions ) were ineligible . Stored sample s were available from ION-1 for retrospective testing for illicit drugs by enzyme-linked immunosorbent assay . RESULTS Among 1952 patients enrolled in the ION studies , 4 % ( n = 70 ) were receiving OST . Among those receiving ( n = 70 ) and not receiving OST ( n = 1882 ) , there was no difference in treatment completion ( 97 % vs 98 % ; P = .40 ) , ≥80 % adherence ( 93 % vs 92 % ; P = 1.00 ) , SVR12 ( 94 % vs 97 % ; P = .28 ) , and serious adverse events ( 4 % vs 3 % ; P = .43 ) , respectively . Among participants in the ION-1 trial , 23 % ( n = 196 ) used illicit drugs during therapy ( 15 % cannabinoids alone ; 8 % other illicit drugs ± cannabinoids ) . There was no difference in treatment completion , ≥80 % adherence , SVR12 , or serious AEs in those with no drug use during treatment compared with those who used cannabinoids and /or other illicit drugs . No cases of HCV reinfection were observed in the 24 weeks following treatment . CONCLUSIONS OST and drug use during HCV therapy did not impact treatment completion , adherence , SVR12 , or safety . CLINICAL TRIALS REGISTRATION ION-1 ( NCT01701401 ) ; ION-2 ( NCT01768286 ) ; and ION-3 ( NCT01851330 ) In this analysis of the ASTRAL trials ( non-opioid substitution therapy [ OST ] , n = 984 ; OST , n = 51 ) evaluating the once-daily , pan-genotypic regimen of sofosbuvir/velpatasvir for hepatitis C virus infection , OST did not impact completion , adherence , sustained virologic response ( SVR12 ) , or safety . SVR12 was 96 % ( 95 % confidence interval , 87 % , > 99 % ) in those receiving OST BACKGROUND A barrier to hepatitis C virus ( HCV ) treatment among people who inject drugs ( PWID ) has been a concern that interferon-based HCV treatment may increase injecting risk behaviours . This study evaluated recent ( past month ) injecting risk behaviours during follow-up among PWID that did and did not receive HCV treatment . METHODS The Australian Trial in Acute Hepatitis C ( ATAHC ) was a prospect i ve study of natural history and treatment of recent HCV infection . Analyses were performed using generalized estimating equations . RESULTS Among 124 participants with a history of injecting drug use ( median age 32 years ) , 69 % were male , and 68 % were treated for HCV infection . HCV treatment was not associated with an increase in recent injecting drug use ( adjusted odds ratio ( aOR ) 1.06 , 95 % CI 0.93 , 1.21 ) or recent used needle and syringe borrowing during follow-up ( aOR 0.99 , 95 % CI 0.89 , 1.08 ) . HCV treatment was associated with a decrease in recent ancillary injecting equipment sharing during follow-up ( aOR 0.85 , 95 % CI 0.74 , 0.99 ) . Further , among treated participants who remained in follow-up ( n=24 ) , ancillary injecting equipment sharing significantly decreased from 54 % at enrolment to 17 % during follow-up ( P=0.012 ) . CONCLUSIONS HCV treatment was not associated with drug use or used needle and syringe borrowing during follow-up , but was associated with decreased ancillary injecting equipment sharing during follow-up . Programs to enhance HCV assessment and treatment among PWID should be exp and ed , given that HCV treatment does not lead to increases in injecting risk behaviours and has previously been demonstrated to be safe and effective among PWID Background Hepatitis C virus ( HCV ) infection is common in persons who inject drugs ( PWID ) . Objective To evaluate elbasvir-grazoprevir in treating HCV infection in PWID . Design R and omized , placebo-controlled , double-blind trial . ( Clinical Trials.gov : NCT02105688 ) . Setting Australia , Canada , France , Germany , Israel , the Netherl and s , New Zeal and , Norway , Spain , Taiwan , the United Kingdom , and the United States . Patients 301 treatment-naive patients with chronic HCV genotype 1 , 4 , or 6 infection who were at least 80 % adherent to visits for opioid agonist therapy ( OAT ) . Intervention The immediate-treatment group ( ITG ) received elbasvir-grazoprevir for 12 weeks ; the deferred-treatment group ( DTG ) received placebo for 12 weeks , no treatment for 4 weeks , then open-label elbasvir-grazoprevir for 12 weeks . Measurements The primary outcome was sustained virologic response at 12 weeks ( SVR12 ) , evaluated separately in the ITG and DTG . Other outcomes included SVR24 , viral recurrence or reinfection , and adverse events . Results The SVR12 was 91.5 % ( 95 % CI , 86.8 % to 95.0 % ) in the ITG and 89.5 % ( 95 % CI , 81.5 % to 94.8 % ) in the active phase of the DTG . Drug use at baseline and during treatment did not affect SVR12 or adherence to HCV therapy . Among 18 patients with posttreatment viral recurrence through 24-week follow-up , 6 had probable reinfection . If the probable reinfections were assumed to be responses , SVR12 was 94.0 % ( CI , 89.8 % to 96.9 % ) in the ITG . One patient in the ITG ( 1 of 201 ) and 1 in the placebo-phase DTG ( 1 of 100 ) discontinued treatment because of an adverse event . Limitation These findings may not be generalizable to PWID who are not receiving OAT , nor do they apply to persons with genotype 3 infection , a common strain in PWID . Conclusion Patients with HCV infection who were receiving OAT and treated with elbasvir-grazoprevir had high rates of SVR12 , regardless of ongoing drug use . These results support the removal of drug use as a barrier to interferon-free HCV treatment for patients receiving OAT . Primary Funding Source Merck &
Output:
| However , theoretical model projections suggest that substantial reductions in HCV transmission among PWID will require both traditional harm reduction/ primary prevention and HCV treatment scale-up [ 13,14 ] . |
MS213159 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background There is some evidence that school-based interventions are effective in preventing childhood obesity . However , longer term outcomes , equity of effects and cost-effectiveness of interventions have not been assessed . The aim of this trial is to assess the clinical and cost-effectiveness of a multi-component intervention programme targeting the school and family environment through primary schools , in preventing obesity in 6–7 year old children , compared to usual practice . Methods This cluster r and omised controlled trial is set in 54 primary schools within the West Midl and s , UK , including a multi-ethnic , socioeconomically diverse population of children aged 6–7 years . The 12-month intervention consists of healthy diet and physical activity promotion . These include : activities to increase time spent doing physical activity within the school day , participation in the ‘ Villa Vitality ’ programme ( a programme that is delivered by an iconic sporting institution ( Aston Villa Football Club ) , which provides interactive learning opportunities for physical activity and healthy eating ) , healthy cooking skills workshops in school time for parents and children , and provision of information to families signposting local leisure opportunities . The primary ( clinical ) outcome is the difference in body mass index ( BMI ) z-scores between arms at 3 and 18 months post-intervention completion . Cost per Quality Adjusted Life Year ( QALY ) will also be assessed . The sample size estimate ( 1000 children split across 50 schools at follow-up ) is based on 90 % power to detect differences in BMI z-score of 0.25 ( estimated ICC ≤ 0.04 ) , assuming a correlation between baseline and follow-up BMI z-score of 0.9 . Treatment effects will be examined using mixed model ANCOVA . Primary analysis will adjust for baseline BMI z-score , and secondary analysis will adjust for pre-specified baseline school and child level covariates . Discussion The West Midl and s ActiVe lifestyle and healthy Eating in School children ( WAVES ) study is the first trial that will examine the cost-effectiveness and long term outcomes of a childhood obesity prevention programme in a multi-ethnic population , with a sufficient sample size to detect clinical ly important differences in adiposity . The intervention was developed using the Medical Research Council framework for complex interventions , and outcomes are measured objective ly , together with a comprehensive process evaluation . Trial registration Current Controlled Trials IS RCT N97000586 ( registered May 2010 ) Objective To investigate the effectiveness of a school based intervention to increase physical activity , reduce sedentary behaviour , and increase fruit and vegetable consumption in children . Design Cluster r and omised controlled trial . Setting 60 primary schools in the south west of Engl and . Participants Primary school children who were in school year 4 ( age 8 - 9 years ) at recruitment and baseline assessment , in year 5 during the intervention , and at the end of year 5 ( age 9 - 10 ) at follow-up assessment . Intervention The Active for Life Year 5 ( AFLY5 ) intervention consisted of teacher training , provision of lesson and child-parent interactive homework plans , all material s required for lessons and homework , and written material s for school newsletters and parents . The intervention was delivered when children were in school year 5 ( age 9 - 10 years ) . Schools allocated to control received st and ard teaching . Main outcome measures The pre-specified primary outcomes were accelerometer assessed minutes of moderate to vigorous physical activity per day , accelerometer assessed minutes of sedentary behaviour per day , and reported daily consumption of servings of fruit and vegetables . Results 60 schools with more than 2221 children were recruited ; valid data were available for fruit and vegetable consumption for 2121 children , for accelerometer assessed physical activity and sedentary behaviour for 1252 children , and for secondary outcomes for between 1825 and 2212 children for the main analyses . None of the three primary outcomes differed between children in schools allocated to the AFLY5 intervention and those allocated to the control group . The difference in means comparing the intervention group with the control group was –1.35 ( 95 % confidence interval –5.29 to 2.59 ) minutes per day for moderate to vigorous physical activity , –0.11 ( –9.71 to 9.49 ) minutes per day for sedentary behaviour , and 0.08 ( –0.12 to 0.28 ) servings per day for fruit and vegetable consumption . The intervention was effective for three out of nine of the secondary outcomes after multiple testing was taken into account : self reported time spent in screen viewing at the weekend ( –21 ( –37 to –4 ) minutes per day ) , self reported servings of snacks per day ( –0.22 ( –0.38 to –0.05 ) ) , and servings of high energy drinks per day ( –0.26 ( –0.43 to –0.10 ) ) were all reduced . Results from a series of sensitivity analyses testing different assumptions about missing data and from per protocol analyses produced similar results . Conclusion The findings suggest that the AFLY5 school based intervention is not effective at increasing levels of physical activity , decreasing sedentary behaviour , and increasing fruit and vegetable consumption in primary school children . Change in these activities may require more intensive behavioural interventions with children or upstream interventions at the family and societal level , as well as at the school environment level . These findings have relevance for research ers , policy makers , public health practitioners , and doctors who are involved in health promotion , policy making , and commissioning services . Trial registration Current Controlled Trials IS RCT N50133740 Background Schools are key setting s for childhood obesity prevention , and the location for many intervention studies . This qualitative study aims to explore parent and child experiences of the WAVES study obesity prevention intervention , in order to gain underst and ing of the mechanisms by which the intervention results in behaviour change , and provide context to support interpretation of the main trial results . Methods Focus groups were held with 30 parents and 62 children ( aged 6 - 7 years ) from primary schools in the West Midl and s , UK . Data analysis ( conducted using NVivo 10 ) was guided by the Framework Approach . Results Three over-arching themes were identified : ‘ Impact ’ , ‘ Sustainability ’ and ‘ Responsibilities ’ , under which sub-themes were determined . Participants were supportive of the school-based intervention . Parental involvement and the influential role of the teacher were seen as key ingredients for success in promoting consistent messages and empowering some parents to make positive behavioural changes at home . Parents recognised that whilst they held the primary responsibility for obesity prevention in their children , they faced a number of barriers to healthier lifestyles , and agreed that schools have an important role to play . Conclusions This study enabled us to better underst and aspects of the WAVES study intervention programme that have the potential to initiate positive behaviour changes in families , and indicated that a combination of pathways influenced such changes . Pathways included : increasing capability through improving knowledge and skills of children and parents ; increasing motivation through parental empowerment and role modelling ; and the direct provision of opportunities to lead healthier lifestyles . Strategies to sustain behaviour changes , and the school role in supporting these , are important considerations OBJECTIVE To examine whether dietary intake reported by school-aged children relates to the chronological period of data collection . DESIGN Cross-sectional surveys in 39 countries in different monthly periods of the 2009 - 2010 school year . SETTING S Question naires were completed in schools anonymously . PARTICIPANTS Children from 39 countries , aged 11 , 13 , and 15 years ( n = 209,320 ) . MAIN OUTCOME MEASURES Daily consumption of fruits , vegetables , sweets , and soft drinks , derived from a food frequency question naire . ANALYSIS Multivariate logistic regression ( applied for 3 countries ) ; 2-level r and om intercept logistic regression ( applied for 36 countries ) . RESULTS Monthly variations in food intake among students from Canada , Engl and , and Norway , where data collection took place almost all months of the school year , revealed significantly lower daily consumption of food items in January to February . A 2-level r and om intercept logistic regression model for 36 countries , where question naires were administered in relatively shorter periods , indicated the lowest likelihood of fruit and soft drink consumption when the data were collected in March to April ( β = -0.30 ; P = .006 , compared with October to December ) and in January to February ( β = -0.65 ; P = .018 , compared with May to June ) , respectively . CONCLUSIONS AND IMPLICATION S The chronological period of data collection must be considered when comparing children 's reported food consumption , but this effect is small relative to cross-national variations in dietary patterns BACKGROUND / OBJECTIVES Childhood obesity is a major public health concern but evidence -based approaches to tackle this epidemic sustainably are still lacking . The Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS ( IDEFICS ) study investigated the aetiology of childhood obesity and developed a primary prevention programme . Here , we report on the effects of the IDEFICS intervention on indicators of body fatness . SUBJECTS/ METHODS The intervention modules addressed the community , school and parental level , focusing on diet , physical activity and stress-related lifestyle factors . A cohort of 16,228 children aged 2 - 9.9 years - about 2000 per country - was equally divided over intervention and control regions . ( Participating countries were Sweden , Germany , Estonia , Hungary , Cyprus , Italy , Spain and Belgium . ) We compared the prevalence of overweight/obesity and mean values of body mass index z-score , per cent body fat and waist-to-height ratio over 2 years of follow-up . Mixed models adjusting for age and socioeconomic status of the parents and with an additional r and om effect for country accounted for the clustered study design . RESULTS The prevalence of overweight and obesity increased in both the intervention and control group from 18.0 % at baseline to 22.9 % at follow-up in the control group and from 19.0 % to 23.6 % in the intervention group . The difference in changes between control and intervention was not statistically significant . For the cohort as a whole , the changes in indicators of body fatness did not show any clinical ly relevant differences between the intervention and control groups . Changes in favour of intervention treatment in some indicators were counterbalanced by changes in favour of the control group in some other indicators . CONCLUSIONS Over the 2-year-observation period , the IDEFICS primary prevention programme for childhood obesity has not been successful in reducing the prevalence of overweight and obesity nor in improving indicators of body fatness in the target population as a whole Background The implementation of a complex intervention is heavily influenced by individual context . Variation in implementation and tailoring of the intervention to the particular context will occur , even in a trial setting . It is recognised that in trials , evaluating the process of implementation of a complex intervention is important , yet process evaluation methods are rarely reported . The WAVES study is a cluster r and omised controlled trial to evaluate the effectiveness of an obesity prevention intervention programme targeting children aged 6 - 7 years , delivered by teachers in primary schools across the West Midl and s , UK . The intervention promoted activities encouraging physical activity and healthy eating . This paper presents the methods used to assess implementation of the intervention . Methods Previous literature was used to identify the dimensions of intervention process and implementation to be assessed , including adherence , exposure , quality of delivery , participant responsiveness , context , and programme differentiation . Results Multiple methods and tools were developed to capture information on all these dimensions . These included observations , logbooks , qualitative evaluation , question naires and research team reflection . Discussion Data collection posed several challenges , predominantly when relying on teachers to complete paperwork , which they saw as burdensome on top of their teaching responsibilities . However , the use of multiple methods helped to ensure data on each dimension , where possible , was collected using more than one method . This also allowed for triangulation of the findings when several data sources on any one dimension were available . Conclusions We have reported a comprehensive approach to the assessment of the implementation and processes of a complex childhood obesity prevention intervention within a cluster r and omised controlled trial . These approaches can be transferred and adapted for use in other complex intervention trials . Trial registration numberIS RCT Objective To assess feasibility and acceptability of a multifaceted , culturally appropriate intervention for preventing obesity in South Asian children , and to obtain data to inform sample size for a definitive trial . Design Phase II feasibility study of a complex intervention . Setting 8 primary schools in inner city Birmingham , UK , within population s that are predominantly South Asian . Participants 1090 children aged 6–8 years took part in the intervention . 571 ( 85.9 % from South Asian background ) underwent baseline measures . 85.5 % ( n=488 ) were followed up 2 years later . Interventions The 1-year intervention consisted of school-based and family-based activities , targeting dietary and physical activity behaviours . The intervention was modified and refined throughout the period of delivery . Main outcome measures Acceptability and feasibility of the intervention and of measurements required to assess outcomes in a definitive trial . The difference in body mass index ( BMI ) z-score between arms was used to inform sample size calculations for a definitive trial . Results Some intervention components ( increasing school physical activity opportunities , family cooking skills workshops , signposting of local leisure facilities and attending day event at a football club ) were feasible and acceptable . Other components were acceptable , but not feasible . Promoting walking groups was neither acceptable nor feasible . At follow-up , children in the intervention compared with the control group were less likely to be obese ( OR 0.41 ; 0.19 to 0.89 ) , and had lower adjusted BMI z-score ( −0.15 kg/m2 ; 95 % CI −0.27 to −0.03 ) . Conclusions The feasibility study informed components for an intervention programme . The
Output:
| The primary analyses suggest that this experiential focused intervention had no statistically significant effect on BMI z score or on preventing childhood obesity .
Schools are unlikely to impact on the childhood obesity epidemic by incorporating such interventions without wider support across multiple sectors and environments .
Correspondence to : P Adab [email protected] Cite this as : BMJ 2018;360:k211 http://dx.doi.org/10.1136/bmj.k211 Accepted : 19 December 2017 WhAT IS AlReAdy knoWn on ThIS TopIC Comprehensive systematic review s have suggested that school based interventions could be effective in preventing childhood obesity in high income countries Heterogeneity in intervention components and outcomes limit practical recommendations Furthermore , inconsistent findings in relation to differential effects on subgroups , and impact on inequalities , limited data on potential harms , process measures , and long term effects , as well as lack of data on cost effectiveness , restrict interpretation and wider applicability WhAT ThIS STudy AddS The WAVES study evaluated a theoretically informed , skills based intervention targeting children ’s diet and physical activity behaviours through schools and families It did not result in any meaningful effect on adiposity , dietary intake , or physical activity after 15 or 30 months Although such interventions can fulfil the responsibility of schools for wider education , without upstream support they are unlikely to halt the childhood obesity |
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Input: BACKGROUND There is increasing awareness of the prognostic value of residual symptomatology in affective disorders and of the need for specific therapeutic strategies in this phase of illness . The aims of the study were to apply a novel , short-term psychotherapeutic approach for increasing well-being , based on Ryff 's conceptual model , to remitted patients with affective disorders and to compare the results with those obtained with symptom-oriented cognitive behavioural strategies . METHODS Twenty patients with affective disorders ( major depression , panic disorder with agoraphobia , social phobia , generalized anxiety disorder , obsessive-compulsive disorder ) who had been successfully treated by behavioural or pharmacological methods were r and omly assigned to a well-being enhancing therapeutic strategy ( well-being therapy ) or cognitive-behavioural treatment of residual symptoms . RESULTS Both well-being and cognitive-behavioural therapies were associated with a significant reduction of residual symptoms . However , a significant advantage of well-being therapy over cognitive-behavioural strategies was observed with observer-rated methods . DISCUSSION These preliminary results suggest the feasibility of well-being therapy in the residual stage of affective disorders . Further research should determine its value as a relapse-preventive strategy in specific mood and anxiety disorders Abract Fifty-four children and adolescents ( age 8–17 ) were assessed two years after a clinical intervention trial of cognitive-behavioural vs. non-focused treatment for depression . Eleven ( 20.4 % ) subjects fulfilled criteria for depression , while 21 ( 38.9 % ) reported significant depressive symptoms during the previous year . Seventeen young people ( 31.5 % ) had a psychiatric disorder ( including depression ) . Overall , the sample maintained the improvement since the termination of treatment , without detecting specific treatment effects . Presence of depression at two-year follow-up was best predicted by self-esteem ratings before and after treatment , and co-morbidity at post-treatment . Depression in young life carries a high risk of recurrence , despite initial remission . Continuation or preventative treatment for young people at risk of relapse needs development and evaluation OBJECTIVE To determine whether continuation of cognitive-behavioral therapy ( CBT-C ) could prevent relapse in adolescent psychiatric patients who had remitted from major depressive disorder ( MDD ) . METHOD Seventeen patients who continued to have CBT-C for 6 months after remission from MDD were compared with a historical control group of 12 cases who had no further treatment after remission . RESULTS Only 1 of the 17 cases who continued with CBT-C dropped out . The cumulative relapse risk during CBT-C was significantly lower ( 0.2 ) than it had been in the historical control group ( 0.5 ) . CONCLUSIONS CBT-C warrants further investigation in a r and omized , controlled trial OBJECTIVE This paper presents retrospective and prospect i ve data regarding time course parameters of major depressive disorder ( MDD ) in community adolescents ( 14 to 18 years old ) : time to onset and recovery and , among those who recovered , time to recurrence . METHOD Diagnostic interviews were conducted with 1,508 r and omly selected high school students . Three hundred sixty-two had experienced at least one past or current episode of MDD . RESULTS Mean age at onset of first episode was 14.9 ( SD = 2.8 ) . Early MDD onset was associated with female gender and suicidal ideation . MDD episode duration ranged from 2 to 520 weeks , with a mean of 26.4 weeks ( SE = 3.3 ) and a median of 8.0 weeks . Longer episodes were observed in those whose depression occurred early ( at or before age 15 ) , whose depression had been accompanied by suicidal ideation , and for whom treatment was sought . Of the adolescents who recovered , 5 % relapsed within 6 months , 12 % within 1 year , and approximately 33 % within 4 years . Shorter time to recurrence was associated with prior suicidal ideation and attempt and with later first onset . CONCLUSIONS Risk of MDD is low in childhood , increasing substantially with adolescence . The majority of episodes in community adolescents are relatively brief , although the risk of recurrence is substantial . Suicidal behaviors are important mediators of episode duration and of recurrence OBJECTIVE This study evaluated efficacy of a manual-based bereavement group intervention for children who suffered suicide of a parent or sibling . METHOD Seventy-five families ( 102 children ) were screened from medical examiners ' lists of suicide victims . Fifty-two families ( 75 children ) were eligible and assigned in alternating order to receive ( 27 families , 39 children ) or not to receive ( 25 families , 36 children ) the intervention . Intervention efficacy was evaluated as change in children 's symptoms of anxiety , depression , posttraumatic stress , social adjustment , and parents ' depressive symptoms from initial to outcome assessment s. RESULTS Changes in anxiety and depressive symptoms were significantly greater among children who received the intervention than in those who did not . A greater dropout of children assigned not to receive ( 75 % ) than to receive ( 18 % ) intervention led to an imbalance in retention of intervention and nonintervention participants . CONCLUSIONS A bereavement group intervention focusing on reactions to death and suicide and strengthening coping skills can lessen distress of children bereaved after parental or sibling suicide . Such intervention may prevent future morbidities Twenty families participated in a r and om assignment trial of two cognitive psychoeducational preventive interventions for families with parental affective disorder . Twelve families were assigned to a clinician-based intervention and eight to a lecture-based intervention , with assessment prior to intervention and an average of 18 weeks following intervention . Both groups were satisfied and believed they received help from the intervention . The clinician-based group was significantly more satisfied overall , and reported significantly more changes in both behaviors and attitudes about their illness from pre- to postintervention . Both groups showed significant decrease in degree of upset over issues of concern from pre- to postintervention . The clinician-based group reported receiving significantly more help with their primary concern . The implication s of these findings are discussed Thirty-seven families who had a child between the ages of 8 and 15 ( mean age = 12.0 years ) and had at least one parent , who had experienced a recent episode of affective disorder were assigned r and omly to one of two psychoeducational interventions . The interventions ( clinician-facilitated or lecture-group discussion ) were design ed to prevent childhood depression and related problems through decreasing the impact of related risk factors and encouraging resiliency-promoting behaviors and attitudes . They were similar in content but differed in the level of the children 's involvement and the degree to which the families ' individual life experiences were linked to the educational material . Assessment s included st and ard diagnostic and social functioning instruments and interviews design ed specifically for this project to assess behavior and attitude change . Each parent and child was individually assessed by separate assessors who were blind to information about the other family members . Parent participants in both groups reported being satisfied with the intervention . Clinician group participants reported a significantly larger number of overall changes , as well as higher levels of change regarding communications about the illness with their children and increased underst and ing by the children of their illness . Significantly more children in the clinician group also reported they gained a better underst and ing of parental affective illness as a result of their participation in the project This paper describes the development and preliminary efficacy of a program design ed to prevent depressive symptoms in at-risk 10 - 13 year-olds , and relates the findings to the current underst and ing of childhood depression . The treatment targets depressive symptoms and related difficulties such as conduct problems , low academic achievement , low social competence , and poor peer relations , by proactively teaching cognitive techniques . Children were identified as ' at-risk ' based on depressive symptoms and their reports of parental conflict . Sixty-nine children participated in treatment groups and were compared to 73 children in control groups . Depressive symptoms were significantly reduced and classroom behavior was significantly improved in the treatment group as compared to controls at post-test . Six-month follow-up showed continued reduction in depressive symptoms , as well as significantly fewer externalizing conduct problems , as compared to controls . The reduction in symptoms was most pronounced in the children who were most at risk This study explored the intervention processes of an indicated prevention program for high-risk youth . It was hypothesized that intervention effects would be influenced by the direct and mediating effects of teacher social support on both peer group support and perceived personal control . In turn , personal control was hypothesized to mediate between teacher and peer group support , contributing to reductions in depression and suicide risk behaviors . The hypotheses were tested using a three-wave , longitudinal design incorporating data from preintervention , 5-month follow-up , and 10-month follow-up assessment s of 106 high-risk youth divided into three comparison groups : two experimental , one control . For the two intervention groups , there were direct and /or indirect effects of teacher and peer group support on personal control , depression , and suicide risk behaviors . The general hypothesis that personal control mediates between support re sources and reductions in depression and suicide risk behaviors received partial support across the study groups BACKGROUND Adolescent offspring of depressed parents are at high risk for development of depression . Cognitive restructuring therapy holds promise for preventing progression to depressive episodes . METHODS A r and omized , controlled trial was conducted to prevent depressive episodes in at-risk offspring ( aged 13 - 18 years ) of adults treated for depression in a health maintenance organization ( HMO ) . Potential adult cases were found by review ing the HMO pharmacy records for dispensation of antidepressant medication and the mental health appointment system . Medical charts were review ed for a depression diagnosis . Recruitment letters signed by treating physicians were mailed to adults . Eligible offspring had subdiagnostic depressive symptoms insufficient to meet full DSM-III-R criteria for affective disorder and /or a past mood disorder . These youth were r and omized to usual HMO care ( n = 49 ) or usual care plus a 15-session group cognitive therapy prevention program ( n = 45 ) . RESULTS We detected significant treatment-by-time ( program ) effects for the Center for Epidemiological Studies Depression Scale ( P=.005 ) and the Global Assessment of Functioning scores ( P = .04 ) . Survival analysis of incident major depressive episodes during a median 15-month follow-up found a significant advantage ( P = .003 ) for the experimental condition ( 9.3 % cumulative major depression incidence ) compared with the usual-care control condition ( 28.8 % ) . CONCLUSION A brief , group cognitive therapy prevention program can reduce the risk for depression in the adolescent offspring of parents with a history of depression OBJECTIVES This investigation attempted to prevent unipolar depressive episodes in a sample of high school adolescents with an elevated risk of depressive disorder . METHOD Adolescents at risk for future depressive disorder by virtue of having elevated depressive symptomatology were selected with a two-stage case-finding procedure . The Center for Epidemiologic Studies -Depression Scale ( CES-D ) was administered to 1,652 students ; adolescents with elevated CES-D scores were interviewed with the Schedule for Affective Disorders and Schizophrenia for School-Age Children . Subjects with current affective diagnoses were referred to nonexperimental services . The remaining 150 consenting subjects were considered at risk for future depression and r and omized to either a 15-session cognitive group prevention intervention or an " usual care " control condition . Subjects were reassessed for DSM-III-R diagnostic status after the intervention and at 6- and 12-month follow-up points . RESULTS Survival analyses indicated a significant 12-month advantage for the prevention program , with affective disorder total incidence rates of 14.5 % for the active intervention , versus 25.7 % for the control condition . No differences were detected for nonaffective disorders across the study period . CONCLUSION Depressive disorder can be successfully prevented among adolescents with an elevated future risk OBJECTIVE To examine long-term effects of two forms of preventive intervention design ed to increase families ' underst and ing of parental affective disorder and to prevent depression in children . METHOD Thirty-six families who had a nondepressed child between ages 8 and 15 years and a parent who had experienced affective disorder were enrolled and r and omly assigned to either a clinician-facilitated intervention or a lecture discussion group . Each parent and child were assessed prior to r and omization , after intervention , and approximately 1 1/2 years after enrollment . Assessment s included st and ard diagnostic interviews , measures of child and family functioning , and interviews about experience of parental affective disorder and intervention effects . RESULTS Children in the clinician-facilitated group reported greater underst and ing of parental affective disorder , as rated by self-report , rater-generated scales , and parent report , and had better adaptive functioning after intervention . Parents in the clinician-facilitated intervention group reported significantly more change . CONCLUSION Findings from both interventions support the value of a future-oriented resiliency-based approach . The greater effects of the clinician-facilitated intervention support the need for linking cognitive information to families ' life experience and involving children directly in order to achieve long-term effects PURPOSE To evaluate a program design ed to help high school students with depressive symptomology to effectively cope . DESIGN Two-phase experimental study . METHODS Rural high school students ( N = 222 ) , ages 14 through 19 years , were surveyed to identify teens with depressive symptomatology , identify stressful life events
Output:
| While small effect sizes were reported , these were associated with a significant reduction in depressive episodes .
The only analysis in which there was significant statistical heterogeneity was the sub-group analysis by gender where there was variability in the response to different programmes for both girls and boys .
For the most part funnel plots indicate findings are robust for short term effects with no publication bias evident .
Given the gender differences in prevalence , and the change in these that occurs in adolescence with a disproportionate increase in prevalence rates for girls , it is likely that girls and boys will respond differently to interventions . |
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Input: Background Hydrotherapy is highly valued by people with rheumatoid arthritis yet few studies have compared the benefits of exercises in heated water against exercises on l and . In particular , data on quality of life is rarely reported . This is especially important because patients treated with hydrotherapy often report an enhanced sense of well-being . We report a r and omised controlled trial in which we compared the effects of hydrotherapy with exercises on l and on overall response to treatment , physical function and quality of life in patients with rheumatoid arthritis . Methods One hundred and fifteen patients with RA were r and omised to receive a weekly 30-minute session of hydrotherapy or similar exercises on l and for 6 weeks . Our primary outcome was a self-rated global impression of change – a measure of treatment effect on a 7-point scale ranging from 1(very much worse ) to 7 ( very much better ) assessed immediately on completion of treatment . Secondary outcomes including EuroQol health related quality of life , EuroQol health status valuation , HAQ , 10 metre walk time and pain scores were collected at baseline , after treatment and 3 months later . Binary outcomes were analysed by Fisher 's exact test and continuous variables by Wilcoxon or Mann-Whitney tests . Results Baseline characteristics of the two groups were comparable . Significantly more patients treated with hydrotherapy ( 40/46 , 87 % ) were much better or very much better than the patients treated with l and exercise ( 19/40 , 47.5 % ) , p < 0.001 Fisher 's exact test . Eleven patients allocated l and exercise failed to complete treatment compared with 4 patients allocated hydrotherapy ( p = 0.09 ) . Sensitivity analyses confirmed an advantage for hydrotherapy if we assumed non-completers would all not have responded ( response rates 70 % versus 38 % ; p < 0.001 ) or if we assumed that non-completers would have had the same response as completers ( response rates 82 % versus 55 % p = 0.002 ) . Ten metre walk time improved after treatment in both cases ( median pre-treatment time for both groups combined 10.9 seconds , post-treatment 9.1 s , and 3 months later 9.6 s ) . There was however no difference between treatment groups . Similarly there were no significant differences between groups in terms of changes to HAQ , EQ-5D utility score , EQ VAS and pain VAS . Conclusion Patients with RA treated with hydrotherapy are more likely to report feeling much better or very much better than those treated with l and exercises immediately on completion of the treatment programme . This perceived benefit was not reflected by differences between groups in 10-metre walk times , functional scores , quality of life measures and pain scores OBJECTIVE To evaluate the short term efficacy of a community based physical therapy ( PT ) program for people with rheumatoid arthritis ( RA ) through a single blind r and omized controlled trial . METHODS Adults with active RA were referred by their physician for community based PT . Participants were r and omized to either an immediate intervention group [ experimental group ( EG ) ] or a wait list control group ( CG ) . The intervention was a st and ardized program of education and exercise consisting of at least 4 visits or 3 h of PT over 6 weeks . Baseline , 6 , and 12 week assessment s were by a blinded independent assessor . The primary outcome instrument was the Stanford Arthritis Self-Efficacy Scale ( SES ) and secondary outcome measures included the ACREU Rheumatoid Arthritis Knowledge Question naire ( KQ ) and visual analog scale for pain ( VAS ) . Duration of morning stiffness , grip strength , and tender joint count were also collected at each assessment . Outcome analysis was conducted using analysis of variance . RESULTS Of 150 eligible and r and omized participants , 127 completed the study according to protocol . Baseline analysis showed no differences between the EG and CG for demographics , disease status , or other characteristics . At the 6 week assessment , primary outcome analysis for those who completed the protocol identified a mean change ( improvement ) of 13.5 % in the EG and 5.8 % in the CG , representing a 7.7 % difference in change scores between the 2 groups [ F(1,121 ) = 6.03 ; p = 0.015 ] . A statistically significant difference in change scores was also identified for the KQ [ F(1,120 ) = 6.67 ; p = 0.011 ] , but not for the VAS . Disease status measures did not change , except for duration of morning stiffness , which improved by 68.8 min in the EG and 8.3 min in the CG ( F(1,121 ) = 4.50 ; p = 0.036 ] . CONCLUSION Four hours of a community based PT intervention delivered over 6 weeks significantly improved self-efficacy , disease management knowledge and morning stiffness in people with RA OBJECTIVES The aim of this study was to evaluate the effects of moderately intensive pool exercise therapy on patients with rheumatoid arthritis ( RA ) . METHODS Forty-six patients with chronic RA were r and omly assigned to a treatment group and a control group . The treatment group ( n = 20 ) exercised in a temperate pool twice a week for 12 weeks . The control group ( n = 23 ) continued with their previous activities . Aerobic capacity , measured by means of a submaximum bicycle test , and the physical component of the SF-36 were chosen as the primary outcome measures . Two tests of muscle endurance were chosen as the secondary outcome measure . Additional functional tests and instruments were included . RESULTS No significant differences between the groups were found for the primary outcome measures . Significant improvements in the following aspects of muscular function ( P < 0.05 ) were found in the treatment group when their performance was compared with that of the control group : isometric shoulder endurance , grip force , dynamic endurance of lower extremities ( chair test ) and muscle function of lower extremities . Significant improvements were also found for vitality ( SF-36 ) compared with the control group . The improvements in the training group were maintained for 3 months . CONCLUSIONS Pool exercise therapy of moderate intensity significantly improved muscle endurance in the upper and lower extremities in patients with RA , while no impact on aerobic capacity was found . However , the study population was small and there is a need for further studies with larger population The effects of detraining subsequent to strength training on neuromuscular function were examined in 39 recent-onset rheumatoid arthritis ( RA ) patients . Eighteen age- and sex-matched healthy people ( H ) served as controls . Patients were r and omly allocated either to the experimental group ( PE ) , who carried out progressive strength training for 6 months , or to the control group ( PC ) , who maintained only their habitual physical activities . After 6 months , PE returned to their earlier physical activities and strength training was terminated . At baseline , the maximal strength of the trunk extensors ( not significant ) , grip strength and maximal dynamic strength and the shape of the force-time curve of the knee extensors were lower in PE and PC ( P < 0.05 - 0.001 ) than in H. Strength training in PE led to remarkable increases ( P < 0.05 - 0.001 ) in the maximal strength of all muscle groups without changes in the shape of the force-time curve . The increases in muscle strength in PE obtained by strength training were lost to a great degree during the detraining period for the isometric trunk extension ( P < 0.01 ) and flexion ( P < 0.01 ) strength and for the dynamic knee extension strength ( P < 0.05 ) , but not for the grip strength . In PC , trunk extension and flexion strength decreased significantly throughout the study period . At the post-test , all the strength values in both patient groups were much lower than in H. RA is a chronic disease which seems to need continuous physical exercise with sufficient intensity to minimize/prevent the loss of muscle strength and functional capacity OBJECTIVE To evaluate the effects of a 12 month , weight bearing , aerobic exercise program on disease activity , physical function , and bone mineral density ( BMD ) in women with rheumatoid arthritis ( RA ) taking low dose prednisone . METHODS A group of women with RA ( n = 23 ) not receiving steroid therapy and in American College of Rheumatology functional class I or II was compared to 30 steroid treated patients with similar demographics . The latter group was r and omized to usual care ( n = 16 ) or an aerobic , weight bearing exercise program ( n = 14 ) 3 times a week for 12 months . All subjects were recruited from an outpatient rheumatology clinic or physical therapy department and met the study inclusion criteria . Outcome measures included disease activity ( erythrocyte sedimentation rate , active joint count ) , physical function ( Health Assessment Question naire disability index , activity level ) and BMD of the spine and femoral neck ( by dual energy projection radiology ) . RESULTS Subjects in the exercise group had a small but nonsignificant decrease in disease activity and statistically significant improvements in function ( p = 0.05 ) and activity levels ( p = 0.05 ) . BMD remained unchanged in the exercise group , decreased significantly ( p = 0.004 ) in the nonsteroid comparison group ( hip ) , and changed nonsignificantly in the control group . However , between-group changes in spinal BMD of the steroid treated groups was not significant ( p = 0.09 ) . CONCLUSION Women with RA taking low dose steroid therapy can safely participate in a dynamic , weight bearing exercise program with positive effects on their physical function , activity and fitness levels , and BMD with no exacerbation of disease activity OBJECTIVE To investigate the effect of long term high intensity weightbearing exercises on radiological damage of the joints of the h and s and feet in patients with rheumatoid arthritis ( RA ) . METHODS Data of the 281 completers of a 2 year r and omised controlled trial comparing the effects of usual care physical therapy ( UC ) with high intensity weightbearing exercises were analysed for the rate of radiological joint damage ( Larsen score ) of the h and s and feet . Potential determinants of outcome were defined : disease activity , use of drugs , change in physical capacity and in bone mineral density , and attendance rate at exercise sessions . RESULTS After 2 years , the 136 participants in high intensity weightbearing exercises developed significantly less radiological damage than the 145 participants in UC . The mean ( SD ) increase in damage was 3.5 ( 7.9 ) in the exercise group and 5.7 ( 10.2 ) in the UC group , p = 0.045 . Separate analysis of the damage to the h and s and feet suggests that this difference in rate of increase of damage is more pronounced in the joints of the feet than in the h and s. The rate of damage was independently associated with less disease activity , less frequent use of glucocorticoids , and with an improvement in aerobic fitness . CONCLUSION The progression of radiological joint damage of the h and s and feet in patients with RA is not increased by long term high intensity weightbearing exercises . These exercises may have a protective effect on the joints of the feet OBJECTIVE To investigate the effects of a 21-week concurrent strength and endurance training protocol on physical fitness profile in women with early or longst and ing rheumatoid arthritis ( RA ) compared with healthy subjects . METHODS Twenty-three female patients with RA volunteered for the study . Twelve had early RA and eleven had longst and ing RA . Twelve healthy women served as controls . Maximal strength of different muscle groups was measured by dynamometers , walking speed with light cells , and vertical squat jump on the force platform to mirror explosive force . Maximal oxygen uptake was measured by gas analyzer . Six training sessions ( 3 strength training and 3 endurance training ) were carried out in a 2-week period for 21 weeks . RESULTS The training led to large gains in maximal strength both in women with RA and in healthy women ( P < 0.043 - 0.001 ) . The strength gains were accompanied by increases in walking speed ( P < 0.034 - 0.001 ) and vertical squat jump ( P < 0.034 - 0.001 ) . Significant improvements also occurred in maximal aerobic capacity in all groups ( P < 0.023 - 0.014 ) . CONCLUSIONS Both early and longst and ing RA patients with stable disease can safely improve all characteristics of their physical fitness profile using a progressive concurrent strength and endurance training protocol OBJECTIVES To compare quadriceps sensorimotor function , lower limb functional performance and disability in patients with rheumatoid arthritis ( RA ) and healthy subjects , and to investigate the efficacy and safety of a brief rehabilitation regime . METHODS Quadriceps strength , voluntary activation , proprioceptive acuity and the aggregate time [ aggregate functional performance time ( AFPT ) ] taken to perform four common activities [ aggregate functional performance time ( AFPT ) ] were compared between 103 RA patients who had lower limb involvement and 25 healthy subjects . In addition , disability ( Health Assessment Question naire ) , clinical disease activity and the plasma concentration of proinflammatory cytokines were measured in the RA patients . In a follow-on r and omized controlled trial of rehabilitation , these variables were used as baseline data for 93 of the RA patients , who were r and omized to a rehabilitation or a control group . Changes in the variables were analysed within and between groups . RESULTS Compared with healthy subjects , RA patients had weaker quadriceps [ mean difference 157 N ; 95 % confidence interval ( CI ) 125 - 189 ] , poorer activation ( 8 % , 95 % CI 4.5 - 15 ) and proprioceptive acuity ( 0.8 degrees , 95 % CI 0.4 - 1.3 ) and took longer to perform the AFPT ( 34 s , CI 23.5 - 44.
Output:
| This systematic review suggests that the majority of patients with RA should be encouraged to undertake aerobic and /or strength training exercise . |
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Input: This study was design ed to determine the safety and efficacy of the combination therapy of gemcitabine plus carboplatin when used as a second-line treatment in patients with metastatic breast cancer ( MBC ) . From February 2002 to May 2003 , 30 previously treated patients with adenocarcinoma of the breast received gemcitabine 1000 mg/m2 on days 1 and 8 plus carboplatin to an area under the curve ( AUC ) of 5 on day 1 . The carboplatin dose was changed to an AUC of 4.5 because of toxicity , with cycles repeated every 3 weeks . Among 30 patients enrolled , 25 were assessable for response rate ( RR ) . There was no complete response ; 9 patients ( 30 % ) had partial response , for an overall RR of 30 % . The median time to progression for the study group was 20.47 weeks ( range , 8 - 46 weeks ) . Treatment-related toxicities included grade 3/4 neutropenia in 50 % of patients ( 20 % of whom had febrile neutropenia ) , grade 3/4 anemia in 26.6 % of patients , and grade 3/4 thrombocytopenia in 30 % . Eleven patients ( 36.67 % ) had grade 1 alopecia , and 1 patient ( 3.33 % ) had grade 2 alopecia . Moderate nausea was observed in 8 patients ( 26.67 % ) , and vomiting occurred in 7 patients . Four patients had asthenia and 3 ( 10 % ) experienced stomatitis . Three patients discontinued treatment because of hematologic toxicity ( thrombocytopenia ) and 2 patients are still receiving treatment . Carboplatin plus gemcitabine is an active combination for patients with MBC despite significant but manageable hematologic toxicity PURPOSE This study was design ed to determine whether increasing the dose of doxorubicin in or adding paclitaxel to a st and ard adjuvant chemotherapy regimen for breast cancer patients would prolong time to recurrence and survival . PATIENTS AND METHODS After surgical treatment , 3,121 women with operable breast cancer and involved lymph nodes were r and omly assigned to receive a combination of cyclophosphamide ( C ) , 600 mg/m(2 ) , with one of three doses of doxorubicin ( A ) , 60 , 75 , or 90 mg/m(2 ) , for four cycles followed by either no further therapy or four cycles of paclitaxel at 175 mg/m(2 ) . Tamoxifen was given to 94 % of patients with hormone receptor-positive tumors . RESULTS There was no evidence of a doxorubicin dose effect . At 5 years , disease-free survival was 69 % , 66 % , and 67 % for patients r and omly assigned to 60 , 75 , and 90 mg/m(2 ) , respectively . The hazard reductions from adding paclitaxel to CA were 17 % for recurrence ( adjusted Wald chi(2 ) P = .0023 ; unadjusted Wilcoxon P = .0011 ) and 18 % for death ( adjusted P = .0064 ; unadjusted P = .0098 ) . At 5 years , the disease-free survival ( + /- SE ) was 65 % ( + /- 1 ) and 70 % ( + /- 1 ) , and overall survival was 77 % ( + /- 1 ) and 80 % ( + /- 1 ) after CA alone or CA plus paclitaxel , respectively . The effects of adding paclitaxel were not significantly different in subsets defined by the protocol , but in an unplanned subset analysis , the hazard ratio of CA plus paclitaxel versus CA alone was 0.72 ( 95 % confidence interval , 0.59 to 0.86 ) for those with estrogen receptor-negative tumors and only 0.91 ( 95 % confidence interval , 0.78 to 1.07 ) for patients with estrogen receptor-positive tumors , almost all of whom received adjuvant tamoxifen . The additional toxicity from adding four cycles of paclitaxel was generally modest . CONCLUSION The addition of four cycles of paclitaxel after the completion of a st and ard course of CA improves the disease-free and overall survival of patients with early breast cancer Abstract A phase II study was conducted to evaluate the activity and toxicity profile of the combination of docetaxel and gemcitabine in anthracycline-resistant advanced breast cancer ( ABC ) . Thirty-nine eligible patients with a median performance status of I ( range , 0–2 ) were enrolled in the study . Treatment consisted of docetaxel 75 mg/m2 in a 1-hr infusion on day 1 preceded by gemcitabine 1000 mg/m2 over 30 min on days 1 and 8 . One hundred eighty-one treatment cycles were administered , 113 ( 62.4 % ) of them at full dose . Relative dose intensity of gemcitabine and of docetaxel was 0.73 and 0.85 , respectively . More common grade 3–4 toxicities included neutropenia ( 49 % ) , anemia ( 10 % ) , fatigue ( 10 % ) , nausea/vomiting ( 8 % ) , and alopecia ( 77 % ) . Seven patients were hospitalized for febrile neutropenia . Granulocyte colony-stimulating factor ( G-CSF ) administration was required in 90 % of patients . Overall , 14 patients ( 36 % ) responded , 3 ( 7.5 % ) of them completely . Median duration of response was 10.3 months ( range , 4.6–17.5 + ) . Median time to progression was 7 months ( range , 0.2–17.5 + ) and median survival 12.7 months ( range , 2-–20.5 + ) . In conclusion , the combination of docetaxel and gemcitabine , as used in the present study , has moderate activity in anthracycline-resistant ABC . Future studies should incorporate prophylactic administration of G-CSF to reduce the incidence of febrile neutropenia and maintain dose intensity BACKGROUND We wanted to assess the toxicity and efficacy of paclitaxel plus gemcitabine in advanced breast cancer and to confirm whether circulating HER2 extracellular domain ( ECD ) correlates with treatment response . PATIENTS AND METHODS Forty-three patients received paclitaxel 150 mg/m2 followed by gemcitabine 2500 mg/m2 , both on day 1 of 14-day cycles , with a maximum of eight cycles . Serum levels of HER2 ECD were assessed by ELISA . RESULTS All patients were evaluable for toxicity and 42 for efficacy . Overall toxicity was low . Grade 3 neutropenia occurred in 12 % of patients and grade 4 in 17 % , and other grade 3 toxicities in < 5 % . One patient had an allergic infusion reaction . Overall response rate was 71 % [ 95 % confidence interval ( CI ) 62 % to 81 % ] , with 11 patients achieving a complete response ( 26 % ) . With a median follow-up of 26 months , the median time to progression was 16.6 months . Response rate correlated significantly with HER2 ECD , with 42 % of HER2 ECD-positive patients responding versus 83 % of HER2 ECD-negative patients ( P = 0.02 ) . Furthermore , response duration was shorter in patients with positive HER2 ECD levels ( 7.9 versus 14.4 months ; P = 0.04 ) . CONCLUSIONS Paclitaxel plus gemcitabine given as an every 2-weeks schedule is a well tolerated and active regimen in advanced breast carcinoma . This is an attractive combination to use when anthracyclines are not indicated , such as in HER2 positive cases that receive trastuzumab . In addition , elevated levels of HER2 ECD adversely affect the efficacy of treatment PURPOSE Using a 2 x 2 factorial design , we studied the adjuvant chemotherapy of women with axillary node-positive breast cancer to compare sequential doxorubicin ( A ) , paclitaxel ( T ) , and cyclophosphamide ( C ) with concurrent doxorubicin and cyclophosphamide ( AC ) followed by paclitaxel ( T ) for disease-free ( DFS ) and overall survival ( OS ) ; to determine whether the dose density of the agents improves DFS and OS ; and to compare toxicities . PATIENTS AND METHODS A total of 2,005 female patients were r and omly assigned to receive one of the following regimens : ( I ) sequential A x 4 ( doses ) -- > T x 4 -- > C x 4 with doses every 3 weeks , ( II ) sequential A x 4 -- > T x 4 -- > C x 4 every 2 weeks with filgrastim , ( III ) concurrent AC x 4 -- > T x 4 every 3 weeks , or ( IV ) concurrent AC x 4 -- > T x 4 every 2 weeks with filgrastim . RESULTS A protocol -specified analysis was performed at a median follow-up of 36 months : 315 patients had experienced relapse or died , compared with 515 expected treatment failures . Dose-dense treatment improved the primary end point , DFS ( risk ratio [ RR ] = 0.74 ; P = .010 ) , and OS ( RR = 0.69 ; P = .013 ) . Four-year DFS was 82 % for the dose-dense regimens and 75 % for the others . There was no difference in either DFS or OS between the concurrent and sequential schedules . There was no interaction between density and sequence . Severe neutropenia was less frequent in patients who received the dose-dense regimens . CONCLUSION Dose density improves clinical outcomes significantly , despite the lower than expected number of events at this time . Sequential chemotherapy is as effective as concurrent chemotherapy PURPOSE A multicenter Phase II trial was performed to investigate the efficacy and tolerance of combined docetaxel and gemcitabine + /- recombinant human granulocyte colony-stimulating factor ( G-CSF ) in patients with metastatic breast cancer . PATIENTS AND METHODS Fifty-two patients participated in this trial , 51 of whom are evaluable for response . Thirty-eight patients received this combination as first-line chemotherapy , and 14 patients received this combination as second-line chemotherapy , including 10 patients who had failed anthracyclines . Therapy consisted of 1500 mg/m2 gemcitabine and 50 mg/m2 docetaxel , both administered on days 1 and 15 every 4 weeks . Depending on the absolute neutrophil counts on the day of scheduled chemotherapeutic drug administration , a 5-day course of 5 microg/kg G-CSF was given . RESULTS The overall response rate was 60.5 % ( 95 % confidence interval , 43.4 - 75.9 % ) in patients receiving docetaxel plus gemcitabine as first-line chemotherapy , including 4 complete responses ( 10.5 % ) and 19 partial remissions ( 50 % ) ; 9 patients ( 24 % ) had disease stabilization , and only 5 ( 13 % ) progressed . Second-line treatment with this regimen result ed in 6 of 14 ( 43 % ) objective responses , 5 had stable disease , and 3 progressive disease . The median time to progression was 8.5 months in the first-line setting and 6.6 months in the second-line setting , respectively . After a median follow-up time of 15 months , 36 patients ( 69 % ) are still alive with metastatic disease . Myelosuppression was commonly observed ; WHO grade 3 or 4 neutropenia , however , occurred in only 15 ( 29 % ) patients and was complicated by septicemia in 2 cases ; grade 3 anemia was seen in 1 patient ( 2 % ) . Severe ( grade 3 ) nonhematological toxicity except for alopecia was rarely observed and included nausea/vomiting in 3 ( 6 % ) , stomatitis in 2 ( 4 % ) , anaphylaxis in 2 , and peripheral neuropathy , skin toxicity , and increase of liver enzymes each in one patient . CONCLUSION Our data suggest that docetaxel and gemcitabine with and without G-CSF is an effective and fairly well-tolerated regimen for the treatment of advanced breast cancer . It might be particularly useful in patients exposed previously to adjuvant or palliative anthracyclines and /or alkylating agents Purpose : Advanced breast cancer ( ABC ) is an incurable disease . St and ard first-line treatment for patients with HER-2/neu overexpressing tumors includes the combination of the humanized monoclonal antibody trastuzumab with chemotherapy , mainly paclitaxel . This combination is the first to demonstrate a survival advantage in this group of patients . To improve on these results , we investigated a triplet , paclitaxel-gemcitabine-trastuzumab ( TGH ) , in a phase II study . Patients and Methods : Patients with ABC were accrued to the study . Treatment consisted of paclitaxel 80 mg/m2/week , gemcitabine 1000 mg/m2 every 2 weeks , and trastuzumab 4 mg/kg loading dose and then 2 mg/kg/week . Patients were treated on study for a total of 12 weeks . Response evaluation was performed at the end of the 12 weeks . Continuation of treatment beyond the 12
Output:
| Conclusion Available data do not support the acceptance of gemcitabine as a st and ard therapeutic option in women with metastatic breast cancer in the third-line or greater setting , nor should it be considered as first-line therapy in anthracycline naïve women .
Gemcitabine appears to be most effective when administered with a taxane ( docetaxel/paclitaxel ) in the first- or second-line setting , with gemcitabine/taxane combinations representing a viable alternative to currently accepted taxane combinations such as capecitabine/docetaxel .
There is no evidence at this time to support the use of gemcitabine triplets , given the equal efficacy to anthracycline triplets and the added toxicity |
MS213163 | ***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: This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS Boston University Patricia Cortes Harvard University Claudia Goldin Swarthmore College Jennifer The high prevalence of hypercholesterolemia in kidney transplant recipients probably contributes to the high cardiovascular mortality in these patients . Except for diet , there is no generally recommended cholesterol-lowering treatment . We conducted a double-blind , r and omized , placebo-controlled study with low-dose simvastatin in 40 ciclosporin (CS)-treated kidney transplant recipients during 16 weeks , focusing on side effects and dose finding . In the simvastatin group , the mean serum total and LDL cholesterol concentrations decreased by 23 and 33 % , respectively , and the mean serum HDL cholesterol concentration increased by 12 % , after 4 weeks of treatment with simvastatin 10 mg daily . Increasing the dose to 20 mg daily in a few patients only result ed in marginal further reductions of the serum cholesterol concentrations at the expense of doubling the plasma simvastatin 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitory activity concentrations . The differences between the changes in the serum cholesterol concentrations in the simvastatin group and the negligible changes in the placebo group were statistically significant . There was no case of proximal myopathy and the serum creatine kinase concentrations did not differ between treatment groups . In conclusion , low-dose simvastatin appears to be a well tolerated and efficacious cholesterol-lowering treatment in CS-treated kidney transplant recipients . Simvastatin 10 mg daily seems to be the most suitable dose for the majority of these patients Purpose of review To review recent publications concerning the epidemiology and management of cardiovascular disease in the stages of chronic kidney disease . Recent findings Chronic kidney disease is a state of increased risk for atherosclerotic and cardiomyopathic disease . The mechanisms of cardiovascular disease probably change with the different stages of chronic kidney disease . Both proteinuria and decreased glomerular filtration rate are probably independent cardiovascular disease risk factors , although the impact of the latter is modest . Traditional risk factors are important predictors of cardiovascular disease in chronic kidney disease . Recent r and omized controlled trials and cohort studies have supported interventions for smoking cessation , blood pressure control , renin – angiotensin system blockade , the correction of lipid abnormalities , and utilizing antiplatelet agents . Some uraemia-related risk factors predict the development of cardiovascular disease , particularly hypoalbuminaemia , inflammation , anaemia , and homocysteinaemia . However , r and omized controlled trials of anaemia correction and of an increased quantity of dialysis were negative . Summary The role of oxidant stress , divalent ion abnormalities , various lipid abnormalities and other potential factors require further investigation . To determine whether these uraemia-related factors are markers of cardiovascular disease risk or are actually cardiotoxic requires additional r and omized controlled trials The incidence of cardiovascular disease ( CVD ) is very high in patients with chronic kidney ( CKD ) disease and in kidney transplant recipients . Indeed , available evidence for these patients suggests that the 10‐year cumulative risk of coronary heart disease is at least 20 % , or roughly equivalent to the risk seen in patients with previous CVD . Recently , the National Kidney Foundation 's Kidney Disease Outcomes Quality Initiative ( K/DOQI ) published guidelines for the diagnosis and treatment of dyslipidemias in patients with CKD , including transplant patients . It was the conclusion of this Work Group that the National Cholesterol Education Program Guidelines are generally applicable to patients with CKD , but that there are significant differences in the approach and treatment of dyslipidemias in patients with CKD compared with the general population . In the present document we present the guidelines generated by this workgroup as they apply to kidney transplant recipients . Evidence from the general population indicates that treatment of dyslipidemias reduces CVD , and evidence in kidney transplant patients suggests that judicious treatment can be safe and effective in improving dyslipidemias . Dyslipidemias are very common in CKD and in transplant patients . However , until recently there have been no adequately powered , r and omized , controlled trials examining the effects of dyslipidemia treatment on CVD in patients with CKD . Since completion of the K/DOQI guidelines on dyslipidemia in CKD , the results of the Assessment of Lescol in Renal Transplantation ( ALERT ) Study have been presented and published . Based on information from r and omized trials conducted in the general population and the single study conducted in kidney transplant patients , these guidelines , which are a modified version of the K/DOQI dyslipidemia guidelines , were developed to aid clinicians in the management of dyslipidemias in kidney transplant patients . These guidelines are divided into four sections . The first section ( Introduction ) provides the rationale for the guidelines , and describes the target population , scope , intended users , and methods . The second section presents guidelines on the assessment of dyslipidemias ( guidelines 1–3 ) , while the third section offers guidelines for the treatment of dyslipidemias ( guidelines 4–5 ) . The key guideline statements are supported mainly by data from studies in the general population , but there is an urgent need for additional studies in CKD and in transplant patients . Therefore , the last section outlines recommendations for research BACKGROUND Renal transplant recipients are at increased risk of premature cardiovascular disease . Although statins reduce cardiovascular risk in the general population , their efficacy and safety in renal transplant recipients have not been established . We investigated the effects of fluvastatin on cardiac and renal endpoints in this population . METHODS We did a multicentre , r and omised , double-blind , placebo-controlled trial in 2102 renal transplant recipients with total cholesterol 4.0 - 9.0 mmol/L. We r and omly assigned patients fluvastatin ( n=1050 ) or placebo ( n=1052 ) and follow up was for 5 - 6 years . The primary endpoint was the occurrence of a major adverse cardiac event , defined as cardiac death , non-fatal myocardial infa rct ion ( MI ) , or coronary intervention procedure . Secondary endpoints were individual cardiac events , combined cardiac death or non-fatal MI , cerebrovascular events , non-cardiovascular death , all-cause mortality , and graft loss or doubling of serum creatinine . Analysis was by intention to treat . FINDINGS After a mean follow-up of 5.1 years , fluvastatin lowered LDL cholesterol concentrations by 32 % . Risk reduction with fluvastatin for the primary endpoint ( risk ratio 0.83 [ 95 % CI 0.64 - 1.06 ] , p=0.139 ) was not significant , although there were fewer cardiac deaths or non-fatal MI ( 70 vs 104 , 0.65 [ 0.48 - 0.88 ] p=0.005 ) in the fluvastatin group than in the placebo group . Coronary intervention procedures and other secondary endpoints did not differ significantly between groups . INTERPRETATION Although cardiac deaths and non-fatal MI seemed to be reduced , fluvastatin did not generally reduce rates of coronary intervention procedures or mortality . Overall effects of fluvastatin were similar to those of statins in other population During the last decades , transplantation has become an established tool for the treatment of terminal organ failure . Beside immunological factors , hyperlipidemia is the main problem after heart transplantation , causing rapid transplant coronary artery disease ( TxCAD ) and poor long-term prognosis at the beginning of the transplantation . Heart transplant recipients are now effectively treated with lipid lowering substances , of which HMG-CoA-reductase inhibitors are the most potent . However , treatment with these substances correlates with an increased risk for the development of rhabdomyolysis due to therapy with the immunosuppressive cyclosporine A. Our study monitored the safety and efficacy of treatment with the HMG-CoA reductase inhibitor fluvastatin in heart transplant recipients compared to healthy controls . We investigated 10 patients receiving immunosuppressive therapy consisting of cyclosporine A , prednisone , and azathioprine who had increased concentrations of LDL-cholesterol ( LDL-C ) , and 10 age-matched healthy controls . The patients were treated with 40 mg/day fluvastatin for 4 weeks and 20 mg/day for 4 additional weeks . Control individuals received 40 mg/day fluvastatin for 4 weeks only . Parameters of fluvastatin pharmacokinetics ( maximum concentration of the drug ( Cax , ) , time ( tmax ) to reach Cmax , area under the concentration vs. time curve ( AUCOh 24h ) , elimination halflife time ( t,2 ) ) , apparent total body clearance ( CL ) , blood cyclosporine A concentration , plasma lipids , and safety parameters were determined in both study groups at the beginning of the study and after 4 weeks . The latter were determined in the patient group also after 8 and 12 weeks . Treatment with 40 mg/day fluvastatin caused a significant decrease in total cholesterol ( patients : 5.47 ± 1.32 mmol/L vs. 7.30 ± 1.83 mmol/L ; controls : 4.69 ± 0.64 mmolIL vs. 5.81 ± 0.72 mmol/L ) , LDL-C ( patients : 3.28 + 1.25 mmol/L vs. 5.00 ± 1.85 mmol/L ; controls : 2.58 ± 0.63 mmol/L vs. 3.50 ± 0.70 mmolJL ) , and triglycerides ( patients : 1.99 ± 0.77 mmol/L vs. 2.50 ± 1.00 mmol/L ; controls : 1.24 ± 0.46 mmolIL vs. 1.72 ± 0.67 mmol/L ) in both study groups , whereas HDL-C was not significantly changed ( patients : 1.29 ± 0.35 mmol/L vs. 1.17 ± 0.32 mmol/L ; controls : 1.55 ± 0.30 mmol/L vs. 1.53 ± 0.26 mmol/L ) . Values of C,,m , and AUCOh 24h were higher in the patient group than in the control group ( day 1 , patients vs. controls , Cma , : 869.4 ± 604.0 ng/mL vs. 211.9 ± 113.9 ng/mL ; AUCOh24h : 1948.8 ± 1347.9 ng/mL*h vs. 549.4 ± 247.4 ng/mLh ) , whereas the corresponding value of CL was lower in the patient group ( 33.3 ± 24.5 L/h vs. 107.9 ± 95.8 L/h ) , and the values of t , , , . and t,2 showed no differences . In addition , values of C,,m , and AUCOb 24h after administration of 40 mg/day fluvastatin for 4 weeks in both groups were slightly higher than at the beginning , whereas the value of CL was slightly lower ( day 28 , patients vs. controls , C,,a , : 1530.4 ± 960.4 ng/mL vs. 254.7 ± 199.8 ng/mL ; AUCOb-240 : 2615.3 ± 1379.4 ng/mL*h vs. 841.8 ± 421.4 ng/mL*h ; CL : day 28 , 21.4 ± 15.3 L/h vs. 61.5 ± 36.6 L/h ) . Except for an intermittent increase of creatine kinase , safety parameters showed no increases within the observation period . Our data suggest that fluvastatin effectively lowers plasma concentrations of cholesterol and LDL-C in patients after heart transplantation , however , the metabolism of fluvastatin is affected by concomitant therapy with cyclosporine A. Serum concentrations of fluvastatin should be monitored in cases of concomitant therapy with other substances interfering in the metabolism by competing cytochrome enzymes BACKGROUND Patients with chronic kidney disease are at increased risk for cardiovascular disease , but the efficacy and safety of simvastatin and aspirin are unknown in this patient group . METHODS Patients were r and omly assigned in a 2 x 2 factorial design to the
Output:
| The Assessment of Lescol in Renal Transplant trial , the largest trial so far , suggested that dyslipidemia management with statins in RTRs is associated with a significant reduction in the incidence of cardiac death and nonfatal myocardial infa rct ion ( although differences in the combined primary end point were not statistically significant ) . |
MS213164 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Purpose Our intention was to assess the effectiveness of preoperative oral melatonin medication on sedation , sleep quality , and postoperative analgesia in patients undergoing elective prostatectomy . Methods Fifty-two ASA I – II patients undergoing elective prostatectomy were included in this study , r and omly divided into two groups . Patients received an oral placebo ( n = 26 ) or 6 mg melatonin ( n = 26 ) the night before and 1 h before surgery . All patients received a st and ard anesthetic protocol . At the end of surgery , all patients received tramadol i.v . via a PCA device . Extubation time , intraoperative fentanyl consumption , and recovery time were assessed at the end of the operation . Pain scores , tramadol consumption , and sedation scores were assessed at 1 , 2 , 4 , 6 , 12 , 18 , and 24 h postoperatively , and sleep quality and subjective analgesic efficacy were assessed at 24 h after surgery . Results There were no significant differences in demographic data between the groups . Extubation time and recovery time from anesthesia were significantly longer in the melatonin group ( P < 0.05 ) . Intraoperative fentanyl usage , pain scores , and tramadol consumption were significantly lower in the melatonin group ( P < 0.05 ) . The postoperative sleep quality of patients was significantly better in the melatonin group than in the control group ( P < 0.05 ) . Postoperative VAS of pain was significantly lower in the melatonin group compared with the control group at 1 , 2 , 4 , 6 , 12 , 18 , and 24 h postoperatively ( P < 0.05 ) . Subjective analgesic efficacy of patients was significantly different between groups ( P < 0.05 ) . The sedation scores were significantly higher in the melatonin group than in the control group at 1 h and 2 h after surgery ( P < 0.05 ) . Conclusions Preoperative oral melatonin administration decreased pain scores and tramadol consumption and enhanced sleep quality , sedation scores , and subjective analgesic efficacy during the postoperative period We have evaluated the perioperative effects of melatonin with those of midazolam in 75 women in a prospect i ve , r and omized , double-blind , placebo-controlled study . Patients were given sublingual midazolam 15 mg , melatonin 5 mg or placebo , approximately 100 min before a st and ard anaesthetic . Sedation , anxiety and orientation were quantified before , and 10 , 30 , 60 and 90 min after premedication , and 15 , 30 , 60 and 90 min after admission to the recovery room . Psychomotor performance was evaluated at these times also , using the digit-symbol substitution test ( DSST ) and the Trieger dot test ( TDT ) . Patients who received premedication with either midazolam or melatonin had a significant decrease in anxiety levels and increase in levels of sedation before operation compared with controls . Midazolam produced the highest scores for sedation at 30 and 60 min after administration and significant psychomotor impairment in the preoperative period compared with melatonin or placebo . After operation , patients who received midazolam or melatonin premedication had increased levels of sedation at 30 min and impairment in performance on the DSST at 15 , 30 and 90 min compared with controls . There were no significant differences between the three groups for anxiety levels or TDT performance after operation . Amnesia was notable only in the midazolam group for one preoperative event ( entry into the operating room ) . Patient satisfaction was noted in the midazolam and melatonin groups only . We have demonstrated that melatonin can be used effectively for premedication of adult patients The objective of the present study was to assess the toxicology of melatonin ( 10 mg ) , administered for 28 days to 40 volunteers r and omly assigned to groups receiving either melatonin ( N = 30 ) or placebo ( N = 10 ) in a double-blind fashion . The following measurements were performed : polysomnography ( PSG ) , laboratory examinations , including complete blood count , urinalysis , sodium , potassium and calcium levels , total protein levels , albumin , blood glucose , triglycerides , total cholesterol , high-density lipoprotein ( HDL ) , low-density lipoprotein ( LDL ) , and very low-density lipoprotein ( VLDL ) , urea , creatinine , uric acid , glutamic-oxalacetic transaminase ( GOT ) , glutamic-pyruvate transaminase ( GPT ) , bilirubin , alkaline phosphatase , gama-glutamic transaminase ( GGT ) , T3 , T4 , TSH , LH/FSH , cortisol , and melatonin serum concentrations . In addition , the Epworth Somnolence Scale ( ESS ) and a sleep diary ( SD ) were also applied to the volunteers 1 wk before each PSG . In addition , the volunteers were asked about possible side effects ( SE ) that appeared during the treatment . The study was carried out according to the following timetable : Visit 0 , filling out the term of consent and inclusion criteria ; Visit 1 , PSG , laboratory examinations , ESS , SD , melatonin serum concentrations ; Visit 2 , SD , melatonin serum concentrations , SE ; Visit 3 , melatonin serum concentrations , PSG , ESS , SE ; Visit 4 , laboratory examinations , SE , melatonin serum concentrations , SD ; and Visit 5 , PSG , ESS , SE . Analysis of the PSG showed a statistically significant reduction of stage 1 of sleep in the melatonin group . No other differences between the placebo and melatonin groups were obtained . In the present study we did not observe , according to the parameters analyzed , any toxicological effect that might compromise the use of melatonin at a dose of 10 mg for the period of time utilized in this study We have evaluated the level of state and trait anxiety , neuroticism , extroversion and coping style as predictors of the effectiveness of patient-controlled analgesia ( PCA ) in 110 patients undergoing total abdominal hysterectomy . After operation patients were allocated to receive pain control with either PCA or i.m . injections ( IMI ) . Pain was assessed using the short form McGill pain question naire at 6 , 18 and 24 h after operation , and by recording the amount of analgesic consumed in the first 24 h after surgery . Both state anxiety and coping style were significant predictors of postoperative pain , irrespective of the method of analgesia used . Patients using PCA experienced significantly better pain control than those receiving IMI . However , it was those with high levels of state anxiety who experienced the greatest reduction in pain with PCA . In addition to achieving better pain control , patients who received PCA used significantly less analgesia and were discharged earlier than patients who received IMI Aims : To evaluate the effects of melatonin premedication on anxiety and pain scores of patients , operating conditions , and intraocular pressure during cataract surgery under topical anesthesia . Material s and Methods : Sixty patients were r and omly assigned to receive either sublingual melatonin 3 mg or placebo 60 min before surgery . Verbal anxiety scores and verbal pain scores , heart rate , systolic and diastolic blood pressure , intraocular pressure , and quality of operating conditions were recorded . Results : Melatonin significantly reduced the anxiety scores ( median , interquartile range ) from 5 and 5–3 to 3 and 2–4 after premedication and to 3 and 2–3 during surgery and to 0 and 0–1 postoperatively before discharge from the recovery room . There were significant differences between two groups in anxiety scores after premedication ( 95 % CI 3–3.5 ; P = 0.023 ) , intraoperatively ( 95 % CI 2.5–3.5 ; P = 0.007 ) , and postoperatively ( 95 % CI 0.5–1 ; P = 0.007 ) . The surgeon reported better quality of operating conditions in the melatonin group ( P = 0.001 ) . No significant difference in intraoperative and postoperative pain scores , intraocular pressure , heart rate , and systolic and diastolic blood pressure between two groups was recorded . Conclusion : Sublingual melatonin premedication for patients undergoing cataract surgery under topical anesthesia reduced the anxiety scores in patients and provided excellent operating conditions BACKGROUND : The effect of melatonin on the intraoperative requirements for IV anesthetics has not been documented . We studied the effect of melatonin premedication on the propofol and thiopental dose – response curves for abolition of responses to verbal comm and s and eyelash stimulation . METHODS : This prospect i ve , r and omized , double-blind study included 200 adults with ASA physical status I. Patients received either 0.2 mg/kg melatonin or a placebo orally for premedication ( n = 100 per group ) . Approximately 50 min later , subgroups of 10 melatonin and 10 placebo patients were administered various doses of propofol ( 0.5 , 1.0 , 1.5 , 2.0 , or 2.4 mg/kg ) or thiopental ( 2.0 , 3.0 , 4.0 , 5.0 , or 6.0 mg/kg ) for anesthetic induction . The ability of each patient to respond to the comm and , “ open your eyes , ” and the disappearance of the eyelash reflex were assessed 60 s after the end of the injection of propofol or thiopental . Dose – response curves were determined by probit analysis . RESULTS : Melatonin premedication decreased thiopental ED50 values for loss of response to verbal comm and and eyelash reflex from 3.4 mg/kg ( 95%confidence interval , 3.2–3.5 mg/kg ) and 3.7 mg/kg ( 3.5–3.9 mg/kg ) to 2.7 mg/kg ( 2.6–2.9 mg/kg ) and 2.6 mg/kg ( 2.5–2.7 mg/kg ) , respectively ( P < 0.05 ) . Corresponding propofol ED50 values decreased from 1.5 mg/kg ( 1.4–1.6 mg/kg ) and 1.6 mg/kg ( 1.5–1.7 mg/kg ) to 0.9 mg/kg ( 0.8–0.96 mg/kg ) and 0.9 mg/kg ( 0.8–0.95 mg/kg ) , respectively ( P < 0.05 ) . CONCLUSIONS : Melatonin premedication significantly decreased the doses of both propofol and thiopental required to induce anesthesia Background and objectives : Melatonin ( N‐acetyl‐5‐methoxytryptamine ) is the main indolamine secreted by the pineal gl and . Many studies showed that premedication with melatonin is associated with preoperative anxiolysis and sedation without impairment of cognitive and psychomotor skills and without prolonging recovery . We hypothesized that melatonin decreases the amount of propofol required to produce an adequate depth of hypnosis at induction time . Methods : After approval from the research committee of the anaesthesia department , informed written consent was taken from 45 adult patients undergoing different surgical procedures . They were allocated r and omly into three groups according to the premedication . At 100 min preoperatively , premedication was given in the form of oral melatonin 3 mg ( M3 group ) , oral melatonin 5 mg ( M5 group ) or no premedication ( P group ) . After preoxygenation an anaesthesiologist who was blinded to the premedication injected propofol 10 mg over 5 s every 15 s until the bispectral index ( BIS ) score fell to 45 . The total dose of propofol required to achieve a BIS score of 45 was recorded . Response to verbal comm and s and eyelash reflex was evaluated and correlated to the BIS score and propofol dosage . When a BIS score of 45 was reached , tracheal intubation was accomplished after administration of a narcotic and muscle relaxant . Results : The mean ( st and ard devitation ( SD ) ) induction dose of propofol producing a BIS score of 45 was 134 ( 25 ) mg in the placebo group vs. 115 ( 19.5 ) and 114 ( 20.9 ) mg in the M3 and M5 groups , respectively ( P < 0.05 ) . The propofol dose required to achieve loss of eyelash reflex and loss of response to verbal comm and s was more in the placebo group . Anxiety score as assessed by visual analogue scale ( VAS ) scored more in the placebo group than both melatonin groups . Time spent in the recovery room did not differ between the three groups . Conclusion : Melatonin premedication , in an oral dose of either 3 or 5 mg , reduced the required dose of propofol to achieve a BIS score of 45 , reflecting a sufficient level of hypnosis for tracheal intubation without prolongation of postoperative recovery room stay Melatonin has been reported to reduce preoperative anxiety . We performed this study to compare preoperative anxiety in elderly patients receiving melatonin ( M ) or placebo ( P ) . Anxiety was measured in patients aged > 65 yr by a numerical rating scale ( range , 0–10 ) . Each patient was r and omized to receive M 10 m
Output:
| When compared to placebo , melatonin given as premedication ( tablets or sublingually ) can reduce preoperative anxiety in adults ( measured 50 to 100 minutes after administration ) .
Melatonin may be equally as effective as st and ard treatment with midazolam in reducing preoperative anxiety in adults ( measured 50 to 100 minutes after administration ) .
The effect of melatonin on postoperative anxiety ( measured 90 minutes and 6 hours after surgery ) in adults is mixed but suggests an overall attenuation of the effect compared to preoperatively |
MS213165 | ***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 objective of this prospect i ve , r and omized , double-blind study was to evaluate the effect of the addition of mupirocin to the ‘ classical ’ topical SDD regimen ( tobramycin 80 mg , polymyxin E 100 mg , amphotericin B 500 mg ) on the development of ICU-acquired infections due to Gram-positive bacteria . The study was carried out in an intensive care unit ( ICU ) of a 1400-bed community hospital . All patients admitted to the ICU during a 16-month period , who were expected to require mechanical ventilation for more than 24 hours , were r and omized to receive either the ‘ classical ’ SDD regimen ( Group A ) or a modified regimen with mupirocin ( Group B ) . Data from 223 patients requiring mechanical ventilation for at least 48 hours , who were neither infected nor receiving antibiotics on ICU admission , was analysed . A 2 % paste containing tobramycin , polymyxin E and amphotericin B was applied every 6 hours in the oropharynx to the patients in Group A , while in Group B this formula was modified with the addition of 2 % mupirocin . In Group B 0.2 ml of a 2 % mupirocin ointment was also applied four times daily in both nostrils . Patients in Group A received a soft paraffin ointment as a placebo indistinguishable from mupirocin . Patients in both groups received the classic SDD regimen through the nasogastric tube . Systemic antibiotic prophylaxis was not used . Data on lower airway infection , and blood infection , infections of intravascular catheters , antibiotic consumption and expenditures for antibiotics were analysed . The diagnosis of ventilator-associated pneumonia ( VAP ) was based on quantitative cultures of protected specimen brush sample s ( PSB ) or on the results of distal broncho-alveolar lavage ( BAL ) . One hundred and four patients received the ‘ classical ’ SDD and 119 the modified regimen . Overall 29 patients , 20 in Group A and nine in Group B ( p < 0.02 ) had a total of 33 cases of pneumonia . There were 23 episodes of pneumonia in Group A and 10 in Group B ( p < 0.02 ) . Gram-positive bacteria were isolated from sample s in 17 episodes in Group A and six in Group B ( p < 0.02 ) . Staphylococcus aureus was isolated in nine cases of pneumonia in Group A and once in the ‘ mupirocin ’ group ( p < 0.05 ) . MRSA were isolated in seven out of nine cases in Group A and in the only case in Group B. There were no differences in the isolation of Gram-negative bacilli . Antibiotic consumption and cost were lower in Group B. In conclusion , our data show that the topical use of a modified formula of SDD , with the addition of mupirocin to the oral paste and in the anterior nares , is associated with a reduction in lung infections caused by gram-positives and in a reduction in antibiotic consumption and in the overall expenditure for antibiotics BACKGROUND Patients with severe burns are at increased risk of developing methicillin-resistant Staphylococcus aureus ( MRSA ) ventilator-associated pneumonia . This study was design ed to determine whether MRSA pneumonia can be prevented by prophylactic administration of trimethoprim-sulfamethoxazole ( TMP-SMX ) . METHODS We conducted a prospect i ve , r and omized , placebo-controlled study in patients with severe burns ( > or = 20 % ) , who required ventilator support . Prophylaxis was done with oral TMP-SMX ( 80 mg/400 mg ) three times daily for 10 days from 4 to 6 days after burn injury . The incidence of MRSA pneumonia and the side effects were evaluated during the administration period . RESULTS Twenty-one patients were assigned to receive TMP-SMX , and 19 patients to receive placebo . The incidence of MRSA pneumonia was 4.8 % in the TMP-SMX group and 36.8 % in the placebo group , showing a significant difference ( p = 0.017 ) . No major side effects of therapy were seen in the TMP-SMX group . CONCLUSION Prophylactic treatment with TMP-SMX can prevent MRSA pneumonia in severely burned patients IMPORTANCE Infections due to Staphylococcus aureus are serious complications of cardiothoracic surgery . A novel vaccine c and i date ( V710 ) containing the highly conserved S. aureus iron surface determinant B is immunogenic and generally well tolerated in volunteers . OBJECTIVE To evaluate the efficacy and safety of preoperative vaccination in preventing serious postoperative S. aureus infection in patients undergoing cardiothoracic surgery . DESIGN , SETTING , AND PARTICIPANTS Double-blind , r and omized , event-driven trial conducted between December 2007 and August 2011 among 8031 patients aged 18 years or older who were scheduled for full median sternotomy within 14 to 60 days of vaccination at 165 sites in 26 countries . INTERVENTION Participants were r and omly assigned to receive a single 0.5-mL intramuscular injection of either V710 vaccine , 60 μg ( n = 4015 ) , or placebo ( n = 4016 ) . MAIN OUTCOME MEASURES The primary efficacy end point was prevention of S. aureus bacteremia and /or deep sternal wound infection ( including mediastinitis ) through postoperative day 90 . Secondary end points included all S. aureus surgical site and invasive infections through postoperative day 90 . Three interim analyses with futility assessment s were planned . RESULTS The independent data monitoring committee recommended termination of the study after the second interim analysis because of safety concerns and low efficacy . At the end of the study , the V710 vaccine was not significantly more efficacious than placebo in preventing either the primary end points ( 22/3528 V710 vaccine recipients [ 2.6 per 100 person-years ] vs 27/3517 placebo recipients [ 3.2 per 100 person-years ] ; relative risk , 0.81 ; 95 % CI , 0.44 - 1.48 ; P = .58 ) or secondary end points despite eliciting robust antibody responses . Compared with placebo , the V710 vaccine was associated with more adverse experiences during the first 14 days after vaccination ( 1219/3958 vaccine recipients [ 30.8 % ; 95 % CI , 29.4%-32.3 % ] and 866/3967 placebo recipients [ 21.8 % ; 95 % CI , 20.6%-23.1 % ] , including 797 [ 20.1 % ; 95 % CI , 18.9%-21.4 % ] and 378 [ 9.5 % ; 95 % CI , 8.6%-10.5 % ] with injection site reactions and 66 [ 1.7 % ; 95 % CI , 1.3%-2.1 % ] and 51 [ 1.3 % ; 95 % CI , 1.0%-1.7 % ] with serious adverse events , respectively ) and a significantly higher rate of multiorgan failure during the entire study ( 31 vs 17 events ; 0.9 [ 95 % CI , 0.6 - 1.2 ] vs 0.5 [ 95 % CI , 0.3 - 0.8 ] events per 100 person-years ; P = .04 ) . Although the overall incidence of vaccine-related serious adverse events ( 1 in each group ) and the all-cause mortality rate ( 201/3958 vs 177/3967 ; 5.7 [ 95 % CI , 4.9 - 6.5 ] vs 5.0 [ 95 % CI , 4.3 - 5.7 ] deaths per 100 person-years ; P = .20 ) were not statistically different between groups , the mortality rate in patients with staphylococcal infections was significantly higher among V710 vaccine than placebo recipients ( 15/73 vs 4/96 ; 23.0 [ 95 % CI , 12.9 - 37.9 ] vs 4.2 [ 95 % CI , 1.2 - 10.8 ] per 100 person-years ; difference , 18.8 [ 95 % CI , 8.0 - 34.1 ] per 100 person-years ) . CONCLUSIONS AND RELEVANCE Among patients undergoing cardiothoracic surgery with median sternotomy , the use of a vaccine against S. aureus compared with placebo did not reduce the rate of serious postoperative S. aureus infections and was associated with increased mortality among patients who developed S. aureus infections . These findings do not support the use of the V710 vaccine for patients undergoing surgical interventions . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00518687 Background Nosocomial Methicillin-resistant Staphylococcus aureus ( MRSA ) enteritis is rare but can be fatal unless it is detected at an early stage and treated effectively . Dysbiosis of the gut is one of the leading reasons of MRSA enteritis . Fecal microbiota transplantation ( FMT ) is a burgeoning treatment to rectify this imbalance . But the impact of FMT on MRSA enterocoitis is still unknown yet . Methods A total of 5 patients diagnosed as MRSA enteritis during the early postoperative period were given vancomycin 2 g/day for 3 days and FMT for three continuous days as a st and ard treatment . Result There was a 100 % clinical response rate that all the symptoms result ing from MRSA enterocolitis disappeared and MRSA in the feces eliminated clearly . The microbiota profile in feces of the patients also regained balance . Conclusion FMT can be a preferential measure to restore the dysbiosis caused by MSRA enterocolitis BACKGROUND Results of previous single-center , observational studies suggest that daily bathing of patients with chlorhexidine may prevent hospital-acquired bloodstream infections and the acquisition of multidrug-resistant organisms ( MDROs ) . METHODS We conducted a multicenter , cluster-r and omized , nonblinded crossover trial to evaluate the effect of daily bathing with chlorhexidine-impregnated washcloths on the acquisition of MDROs and the incidence of hospital-acquired bloodstream infections . Nine intensive care and bone marrow transplantation units in six hospitals were r and omly assigned to bathe patients either with no-rinse 2 % chlorhexidine-impregnated washcloths or with nonantimicrobial washcloths for a 6-month period , exchanged for the alternate product during the subsequent 6 months . The incidence rates of acquisition of MDROs and the rates of hospital-acquired bloodstream infections were compared between the two periods by means of Poisson regression analysis . RESULTS A total of 7727 patients were enrolled during the study . The overall rate of MDRO acquisition was 5.10 cases per 1000 patient-days with chlorhexidine bathing versus 6.60 cases per 1000 patient-days with nonantimicrobial washcloths ( P=0.03 ) , the equivalent of a 23 % lower rate with chlorhexidine bathing . The overall rate of hospital-acquired bloodstream infections was 4.78 cases per 1000 patient-days with chlorhexidine bathing versus 6.60 cases per 1000 patient-days with nonantimicrobial washcloths ( P=0.007 ) , a 28 % lower rate with chlorhexidine-impregnated washcloths . No serious skin reactions were noted during either study period . CONCLUSIONS Daily bathing with chlorhexidine-impregnated washcloths significantly reduced the risks of acquisition of MDROs and development of hospital-acquired bloodstream infections . ( Funded by the Centers for Disease Control and Prevention and Sage Products ; Clinical Trials.gov number , NCT00502476 . ) BACKGROUND Nasal carriers of Staphylococcus aureus are at increased risk for health care-associated infections with this organism . Decolonization of nasal and extranasal sites on hospital admission may reduce this risk . METHODS In a r and omized , double-blind , placebo-controlled , multicenter trial , we assessed whether rapid identification of S. aureus nasal carriers by means of a real-time polymerase-chain-reaction ( PCR ) assay , followed by treatment with mupirocin nasal ointment and chlorhexidine soap , reduces the risk of hospital-associated S. aureus infection . RESULTS From October 2005 through June 2007 , a total of 6771 patients were screened on admission . A total of 1270 nasal swabs from 1251 patients were positive for S. aureus . We enrolled 917 of these patients in the intention-to-treat analysis , of whom 808 ( 88.1 % ) underwent a surgical procedure . All the S. aureus strains identified on PCR assay were susceptible
Output:
| Mupirocin is effective in preventing S. aureus infections in patients receiving dialysis treatment and in surgical patients , particularly if the patients are carriers of S. aureus .
The combination of mupirocin and chlorhexidine , but not chlorhexidine alone , is also effective against S. aureus infections .
So far , vaccines have not proven successful in protecting against S. aureus infections .
Regarding prophylactic povidone-iodine and systemic antibiotics , there is limited evidence supporting their effectiveness against S. aureus infections .
Antimicrobial honey has not been proven to be more effective or non-inferior to mupirocin in protecting against S. aureus infections .
Conclusions The current evidence supports the use of mupirocin as prophylaxis for preventing infections with S. aureus , particularly in carriers and in the surgical setting or in patients receiving dialysis treatment . |
MS213166 | ***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 Cognitive behavior therapy ( CBT ) is the first-line of treatment for overweight and obesity patients whose problems originate in maladaptive eating habits ( e.g. , emotional eating ) . However , in-person CBT is currently difficult to access by large segments of the population . The proposed SIGMA intervention ( i.e. , the Self-help , Integrated , and Gamified Mobile-phone Application ) is a mHealth intervention based on CBT principles . It specifically targets overweight young adults with underlying maladaptive behaviors and cognitions regarding food . The SIGMA app was design ed as a serious game and intended to work as a st and alone app for weight maintenance or alongside a calorie-restrictive diet for weight loss . It uses a complex and novel scoring system that allows points earned within the game to be supplemented by points earned during outdoor activities with the help of an embedded pedometer . Methods / design The efficacy of the SIGMA mHealth intervention will be investigated within a r and omized , placebo-controlled trial . The intervention will be set to last 2 months with a 3-month follow-up . Selected participants will be young overweight adults with non- clinical maladaptive eating habits embodied by food cravings , binge eating , and emotional eating . The primary outcomes will be represented by changes in ( 1 ) self-reported maladaptive thoughts related to eating and body weight , ( 2 ) self-reported maladaptive eating behaviors in the range of urgent food cravings , emotional eating or binge eating , ( 3 ) as well as biased attentional processing of food items as indexed by reaction times . Secondary outcomes will be represented by changes in weight , Body Mass Index , general mood , and physical activity as indexed by the number of steps per day . Discussion Through an evidence -based cognitive behavioral approach and a user-friendly game interface , the SIGMA intervention offers a significant contribution to the development of a cost-effective and preventive self-help tool for young overweight adults with maladaptive eating habits . Trial registration IS RCT N , ID : 70907354 . Registered on 6 February 2017 . The IS RCT N registration is in line with the World Health Organization Trial Registration Data Set . The present paper represents the original version of the protocol . Any changes to the protocol will be communicated to IS RCT Background Prevention and management of work-related stress and related mental problems is a great challenge . Mobile applications are a promising way to integrate prevention strategies into the everyday lives of citizens . Objective The objectives of this study was to study the usage , acceptance , and usefulness of a mobile mental wellness training application among working-age individuals , and to derive preliminary design implication s for mobile apps for stress management . Methods Oiva , a mobile app based on acceptance and commitment therapy ( ACT ) , was design ed to support active learning of skills related to mental wellness through brief ACT-based exercises in the daily life . A one-month field study with 15 working-age participants was organized to study the usage , acceptance , and usefulness of Oiva . The usage of Oiva was studied based on the usage log files of the application . Changes in wellness were measured by three vali date d question naires on stress , satisfaction with life ( SWLS ) , and psychological flexibility ( AAQ-II ) at the beginning and at end of the study and by user experience question naires after one week ’s and one month ’s use . In-depth user experience interviews were conducted after one month ’s use to study the acceptance and user experiences of Oiva . Results Oiva was used actively throughout the study . The average number of usage sessions was 16.8 ( SD 2.4 ) and the total usage time per participant was 3 hours 12 minutes ( SD 99 minutes ) . Significant pre-post improvements were obtained in stress ratings ( mean 3.1 SD 0.2 vs mean 2.5 SD 0.1 , P=.003 ) and satisfaction with life scores ( mean 23.1 SD 1.3 vs mean 25.9 SD 0.8 , P=.02 ) , but not in psychological flexibility . Oiva was perceived easy to use , acceptable , and useful by the participants . A r and omized controlled trial is ongoing to evaluate the effectiveness of Oiva on working-age individuals with stress problems . Conclusions A feasibility study of Oiva mobile mental wellness training app showed good acceptability , usefulness , and engagement among the working-age participants , and provided increased underst and ing on the essential features of mobile apps for stress management . Five design implication s were derived based on the qualitative findings : ( 1 ) provide exercises for everyday life , ( 2 ) find proper place and time for challenging content , ( 3 ) focus on self-improvement and learning instead of external rewards , ( 4 ) guide gently but do not restrict choice , and ( 5 ) provide an easy and flexible tool for self-reflection Our recent work ( Boyle , Earle , LaBrie , & Smith , 2017 ) showed that the efficacy of personalized normative feedback-based ( PNF ) college alcohol interventions can be improved through the addition of gamified elements including points , chance , competition , and personal avatars . However , participants in that study were compensated with subject pool credit . In the current study , we piloted an up grade d , smartphone-based version of the game , which was design ed to be truly self-sustaining ( i.e. , engaging enough that students play voluntarily without the presence of external motivators ) . First-year students were invited to play the game weekly for six rounds , with participants su bmi tting and voting on their own questions each week and receiving a novel type of feedback in addition to st and ard descriptive PNF : opposite peers ' judgments of participants ' self-reported drinking behavior , or reflective norms . With no play-based incentives , 222 first-year college students voluntarily played the game , CampusG AND R. ANCOVA models revealed that , relative to participants r and omized to receive feedback on control topics during the three intervention rounds , those who received both descriptive and reflective feedback on peer alcohol use had significantly reduced normative perceptions and reduced alcohol use two months post intervention . This was especially true among heavy drinkers . The results suggest that our gamified " G AND R " approach shows promise as a self-sustaining intervention and , further , that high-risk drinkers may benefit disproportionately from this methodology . Thus , self-sustaining interventions represent an encouraging avenue for future research and development and may hold the potential to impact risky college drinking on a large scale Gamified interventions exploit the motivational characteristics of a game in order to provide prevention information and promote behavior change . Despite the modest effect sizes observed in increasingly popular web-based personalized normative feedback ( PNF ) alcohol interventions for college students , previous research has yet to consider how gamification might be used to enhance efficacy . This study examines whether a novel , gamified PNF intervention format , which includes a point-based reward system , the element of chance , and personal icons to visually represent users , is more effective in reducing short-term alcohol use than the st and ard web-based style of PNF currently used on college campuses . Two-hundred and thirty-seven college students were r and omly assigned to receive either a st and ard brief , web-based PNF alcohol intervention or the same alcohol intervention components delivered within a Facebook-connected social game called CampusG AND R ( Gamified Alcohol Norm Discovery and Readjustment ) . In both study conditions participants answered identical questions about their perceptions of peer drinking norms and own drinking and then received the same PNF slides . Two weeks following PNF delivery , participants again reported their perceptions of peers ' alcohol use and own drinking . Students in the CampusG AND R condition reported significantly reduced peer drinking norms and alcohol use at the two-week follow-up relative to students who received identical PNF delivered by st and ard online survey . Further , a mediation model demonstrated that this effect was driven by larger reductions in perceived drinking norms among participants assigned to receive CampusG AND R , relative to control . As web-based PNF is becoming an increasingly universal prevention strategy , findings from this study suggest gamification may represent one method by which intervention efficacy could be substantially improved . The potential method ological and economic benefits associated with gamified PNF interventions are emphasized and directions for future research are discussed Background Virtual reality ( VR ) is not commonly used in clinical rehabilitation , and commercial VR gaming systems may have mixed effects in patients with stroke . Therefore , we developed RehabMaster ™ , a task-specific interactive game-based VR system for post-stroke rehabilitation of the upper extremities , and assessed its usability and clinical efficacy . Methods A participatory design and usability tests were carried out for development of RehabMaster with representative user groups . Two clinical trials were then performed . The first was an observational study in which seven patients with chronic stroke received 30 minutes of RehabMaster intervention per day for two weeks . The second was a r and omised controlled trial of 16 patients with acute or subacute stroke who received 10 sessions of conventional occupational therapy only ( OT-only group ) or conventional occupational therapy plus 20 minutes of RehabMaster intervention ( RehabMaster + OT group ) . The Fugl-Meyer Assessment score ( FMA ) , modified Barthel Index ( MBI ) , adverse effects , and drop-out rate were recorded . Results The requirements of a VR system for stroke rehabilitation were established and incorporated into RehabMaster . The reported advantages from the usability tests were improved attention , the immersive flow experience , and individualised intervention . The first clinical trial showed that the RehabMaster intervention improved the FMA ( P = .03 ) and MBI ( P = .04 ) across evaluation times . The second trial revealed that the addition of RehabMaster intervention tended to enhance the improvement in the FMA ( P = .07 ) but did not affect the improvement in the MBI . One patient with chronic stroke left the trial , and no adverse effects were reported . Conclusions The RehabMaster is a feasible and safe VR system for enhancing upper extremity function in patients with stroke In recent years , there has been increasing discussion of the limitations of traditional r and omized controlled trial ( RCT ) method ologies for the evaluation of eHealth and mHealth interventions , and in particular , the requirement that these interventions be locked down during evaluation . Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment , often leading to validation of tools that are out date d by the time that trial results are published . Furthermore , because behavioral intervention technologies change frequently during real-world deployment , even if a tested intervention were deployed in the real world , its shelf life would be limited . We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles ( rather than a specific locked-down version of the intervention ) , allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles , while continuously improving the functionality and maintaining technological currency . This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles ( TIPs ) aim ed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition . The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology Background Virtual reality exposure therapy ( VRET ) has been shown to be as effective as traditional forms of in vivo exposure therapy for the treatment of specific phobias . However , as with in vivo exposure , VRET still involves relatively high costs and limited accessibility which makes it prohibitive for a large part of the population . Innovative methods using smartphone applications ( apps ) may improve accessibility and scalability of VRET . The aim of this study is to evaluate 0Phobia , a gamified self-guided VRET for acrophobia that is delivered through a smartphone app in combination with rudimentary cardboard virtual reality ( VR ) goggles . Methods / design Participants ( N = 180 , aged 18–65 years ) with acrophobia symptoms will be recruited from the Dutch general population and r and omized to either 0Phobia ( n = 90 ) or a waitlist control condition ( n = 90 ) . 0Phobia will be delivered over a period of 3 weeks and includes psychoeducation , VR exposure , cognitive techniques , monitoring of symptoms , and relapse prevention . The primary outcome measure will be the Acrophobia Question naire . Secondary outcome measures will include user-friendliness , symptoms of anxiety , depression , and mastery . Assessment s will take place online at baseline , directly after the intervention ( post test ) and at follow-up ( 3 months ) . Discussion This study capitalizes on novel technology and recent scientific advances to develop an affordable and scalable treatment modality . Trial registration Netherl and s Trial Register : NTR6442 . Registered on 29 June 2017
Output:
| The most commonly observed gamification elements were levels or progress feedback , points or scoring , rewards or prizes , narrative or theme , personalization , and customization ; the least commonly observed elements were artificial assistance , unlockable content , social cooperation , exploratory or open-world approach , artificial challenge , and r and omness .
The most commonly observed mental health and well-being domains were anxiety disorders and well-being , whereas the least commonly observed domains were conduct disorder and bipolar disorders .
Conclusions Our findings suggest that the current application of gamification to apps and technologies for improving mental health and well-being does not align with the trend of positive reinforcement critiqued in the greater health and well-being literature .
We also observed overlap between the most commonly used gamification techniques and existing behavior change frameworks . |
MS213167 | ***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 Experimental studies have reported associations between short-term exposure to natural outdoor environments ( NOE ) and health benefits . However , they lack insight into mechanisms , often have low external and ecological validity , and have rarely focused on people with some psycho-physiological affection . The aim of this study was to use a r and omized , case-crossover design to investigate : ( i ) the effects of unconstrained exposure to real natural and urban environments on psycho-physiological indicators of people with indications of psychological distress , ( ii ) the possible differential effects of 30 and 30 + 180 minutes exposures , and ( iii ) the possible mechanisms explaining these effects . Material and methods People ( n = 26 ) with indications of psychological distress were exposed to green ( Collserola Natural Park ) , blue ( Castelldefels beach ) and urban ( Eixample neighbourhood ) environments in Catalonia . They were exposed to all environments in groups for a period of 30 + 180 minutes between October 2013 and January 2014 . During the exposure period , participants were instructed to do what they would usually do in that environment . Before , during ( at 30 and 30 + 180 minutes ) and after each exposure , several psycho-physiological measures were taken : mood ( measured as Total Mood Disturbance , TMD ) , attention capacity ( measured as backwards digit-span task ) , stress levels ( measures as salivary cortisol ) , systolic and diastolic blood pressure , heart rate , autonomous nervous system ( assessed as heart rate variability and the indicators : low frequency power ( LF ) , high frequency power ( HF ) , ratio between LF and HF ( LF : HF ) , and coefficients of component variance of LF , HF , and LF : HF ) . We also measured several potential mediators : air pollution , noise , physical activity , social interactions , and self-perceived restoration experience . Results When compared with responses to urban environment , we found statistically significantly lower TMD [ -4.78 ( -7.77 , -1.79 ) points difference ] , and salivary cortisol [ -0.21 ( -0.34 , -0.08 ) log nmol/L ] in the green exposure environment , and statistically significantly lower TMD [ -4.53 ( -7.57 , -1.49 ) points difference ] , and statistically significant favourable changes in heart rate variability indicators ( specifically LF : HF and CCV-LF : HF with around -0.20 points of difference of the indicators ) in the blue exposure environment . Physical activity and self-perceived restoration experience partially mediated the associations between NOE and TMD . Physical activity and air pollution partially mediated the associations between NOE and heart rate variability . Discussion and conclusions This study extends the existing evidence on the benefits of NOE for people 's health . It also suggests NOE potential as a preventive medicine , specifically focusing on people with indications of psychological distress . Trial registration Clinical trials.gov In recent times , attention has been focused on the role of urban green spaces in promoting human health and well-being . However , there is a lack of evidence -based research on the physiological effects of walking in urban green areas . This study aim ed to clarify the physiological and psychological effects of walking in urban parks during fall . Twenty-three males ( mean age 22.3 ± 1.2 years ) were instructed to walk predetermined 15-min courses in an urban park and in a nearby city area ( control ) . Heart rate and heart rate variability were measured to assess physiological responses , and the semantic differential method , Profile of Mood States , and State-Trait Anxiety Inventory were used to measure psychological responses . We observed that walking in an urban park result ed in a significantly lower heart rate , higher parasympathetic nerve activity , and lower sympathetic nerve activity than walking through the city area . In subjective evaluations , participants were more “ comfortable , ” “ natural , ” “ relaxed , ” and “ vigorous ” after a walk in the urban park . Furthermore , they exhibited significantly lower levels of negative emotions and anxiety . These findings provide scientific evidence for the physiological and psychological relaxation effects of walking in urban parks during fall Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design MOTIVATION Modern data acquisition based on high-throughput technology is often facing the problem of missing data . Algorithms commonly used in the analysis of such large-scale data often depend on a complete set . Missing value imputation offers a solution to this problem . However , the majority of available imputation methods are restricted to one type of variable only : continuous or categorical . For mixed-type data , the different types are usually h and led separately . Therefore , these methods ignore possible relations between variable types . We propose a non-parametric method which can cope with different types of variables simultaneously . RESULTS We compare several state of the art methods for the imputation of missing values . We propose and evaluate an iterative imputation method ( missForest ) based on a r and om forest . By averaging over many unpruned classification or regression trees , r and om forest intrinsically constitutes a multiple imputation scheme . Using the built-in out-of-bag error estimates of r and om forest , we are able to estimate the imputation error without the need of a test set . Evaluation is performed on multiple data sets coming from a diverse selection of biological fields with artificially introduced missing values ranging from 10 % to 30 % . We show that missForest can successfully h and le missing values , particularly in data sets including different types of variables . In our comparative study , missForest outperforms other methods of imputation especially in data setting s where complex interactions and non-linear relations are suspected . The out-of-bag imputation error estimates of missForest prove to be adequate in all setting s. Additionally , missForest exhibits attractive computational efficiency and can cope with high-dimensional data . AVAILABILITY The package missForest is freely available from http://stat.ethz.ch/CRAN/. CONTACT [email protected] ; The prevalence of depression may be affected by changes in psychiatric practice s and the availability of online mental health information in the past two decades . This study aim ed to evaluate the aggregate prevalence of depression in communities from different countries between 1994 and 2014 and to explore the variations in prevalence stratified by geographical , method ological and socio-economic factors . A total of 90 studies were identified and met the inclusion criteria ( n = 1,112,573 adults ) with 68 studies on single point prevalence , 9 studies on one-year prevalence , and 13 studies on lifetime prevalence of depression . A r and om-effects model meta- analysis that was performed to calculate the aggregate point , one-year and lifetime prevalence of depression calculated prevalences of 12.9 % , 7.2 % and 10.8 % respectively . Point prevalence of depression was significantly higher in women ( 14.4 % ) , countries with a medium human development index ( HDI ) ( 29.2 % ) , studies published from 2004 to 2014 ( 15.4 % ) and when using self-reporting instruments ( 17.3 % ) to assess depression . Heterogeneity was identified by meta-regression and subgroup analysis , and response rate , percentage of women and year of publication , respectively , were determined contribute to depression prevalence . This meta- analysis allows benchmarking of the prevalence of depression during the era when online health information emerged , facilitating future comparisons Introduction Exposure to nature may reduce stress in low-income parents . This prospect i ve r and omized trial compares the effect of a physician ’s counseling about nature with or without facilitated group outings on stress and other outcomes among low-income parents . Material s and methods Parents of patients aged 4–18 years at a clinic serving low-income families were r and omized to a supported park prescription versus independent park prescription in a 2:1 ratio . Parents in both groups received physician counseling about nature , maps of local parks , a journal , and pedometer . The supported group received additional phone and text reminders to attend three weekly family nature outings with free transportation , food , and programming . Outcomes measured in parents at baseline , one month and three months post-enrollment included : stress ( using the 40-point Perceived Stress Scale [ PSS10 ] ) ; park visits per week ( self-report and journaling ) ; loneliness ( modified UCLA-Loneliness Scale ) ; physical activity ( self-report , journaling , pedometry ) ; physiologic stress ( salivary cortisol ) ; and nature affinity ( vali date d scale ) . Results We enrolled 78 parents , 50 in the supported and 28 in the independent group . One-month follow-up was available for 60 ( 77 % ) participants and three-month follow up for 65 ( 83 % ) . Overall stress decreased by 1.71 points ( 95 % CI , -3.15 , -0.26 ) . The improvement in stress did not differ significantly by group assignment , although the independent group had more park visits per week ( mean difference 1.75 ; 95 % CI [ 0.46 , 3.04 ] , p = 0.0085 ) . In multivariable analysis , each unit increase in park visits per week was associated with a significant and incremental decrease in stress ( change in PSS10–0.53 ; 95 % CI [ -0.89 , -0.16 ] ; p = 0.005 ) at three months . Conclusion While we were unable to demonstrate the additional benefit of group park visits , we observed an overall decrease in parental stress both overall and as a function of numbers of park visits per week . Paradoxically the park prescription without group park visits led to a greater increase in weekly park visits than the group visits . To underst and the benefits of this intervention , larger trials are needed . Trial registration Clinical Trials.gov OBJECTIVE To investigate the effects of short-term forest bathing on human health . METHODS Twenty healthy male university students participated as subjects and were r and omly divided into two groups of 10 . One group was sent on a two-night trip to a broad-leaved evergreen forest , and the other was sent to a city area . Serum cytokine levels reflecting inflammatory and stress response , indicators reflecting oxidative stress , the distribution of leukocyte subsets , and plasma endothelin-1 ( ET-1 ) concentrations were measured before and after the experiment to evaluate the positive health effects of forest environments . A profile of mood states ( POMS ) evaluation was used to assess changes in mood states . RESULTS No significant differences in the baseline values of the indicators were observed between the two groups before the experiment . Subjects exposed to the forest environment showed reduced oxidative stress and pro-inflammatory level , as evidence d by decreased malondialdehyde , interleukin-6 , and tumor necrosis factor a levels compared with the urban group . Serum cortisol levels were also lower than in the urban group . Notably , the concentration of plasma ET-1 was much lower in subjects exposed to the forest environment . The POMS evaluation showed that after exposure to the forest environment , subjects had lower scores in the negative subscales , and the score for vigor was increased . CONCLUSION Forest bathing is beneficial to human health , perhaps through preventive effects related to several pathological factors Aims : To assess the relationship between green space proximity , use of green space and depressive symptoms and perceived general health among a r and om sample men and women . Methods : Cross-sectional study of a population -based sample of 6,944 45–72 year old Kaunas city residents . Self-reported question naires provided information on sociodemographic variables , health behaviours , depressive symptoms and poor and very poor perceived general health . Residential proximity to green spaces was defined as living less than 300 m , within interval of 300–999 m , and equal or more than 1 km from a park . The use of the park was divided into two categories : no park use or use < 4hrs/week and use of the park ≥4 h/week . The study received approval from the Kaunas Regional Research Ethics Committee . Multiple logistic regression assessed the associations controlling for confounding variables . Results : The prevalence of depressive symptoms and poor and or very poor perceived general health was higher in women than in men . The association between the use of the park and residential proximity to the park revealed that women living > 300 m from a green space and who used the space ≥4 h/week showed higher odds 1.92 ( 1.11–3.3 ) and 1.68 ( 0.81–3.48 ) of depressive symptoms and poor and very poor perceived general health as compared to those who used the park < 4 hrs/week and residential proximity was > 300 m. Conclusions : The results of our study confirmed an association between use of the green space , residential proximity , and depressive symptoms and poor and very poor perceived general health among women only 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 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 Intervent
Output:
| A small effect was found for reduction in depressive mood following exposure to the natural environment . |
MS213168 | ***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: This prospect i ve , controlled study compared cold compressive dressings with wool and crepe in the postoperative management of patients undergoing total knee replacement ( TKR ) . Forty TKR patients were assessed for blood loss , pain , swelling , and range of motion . Patients in the cold compression group had less blood loss through suction drainage ( 982 mL versus 768 mL ) . A higher proportion of patients in the treatment group did not require blood transfusion postoperatively . Mean opiate requirements were lower in the cold compression group ( 0.57 versus 0.71 mg/kg/48 hours ) . The cold compression device appeared to reduce blood loss and pain following TKR Sixty patients undergoing total knee replacement were r and omized to receive either a cold compression dressing ( Cryo/Cuff , Aircast , UK ) or a modified Robert Jones b and age immediately after surgery . The cold compression dressing was used for a minimum of 6 h per day throughout the hospital stay , and the modified Robert Jones b and age remained in place for 48 h from the time of operation . The 2 groups of patients were compared during their hospital stay for blood loss , range of movement , pain scores and need for analgesia . No difference was found between the 2 groups except for less blood loss in the surgical drains in the cold compression group ( P<0.05 ) . Postoperative complications were seen in both groups , but no complication was associated with either the cold compression dressing or the modified Robert Jones b and age . RésuméEtude r and omisée de 60 patients qui , immédiatement après une arthroplastie totale du genou ont eu soit un pansement compressif froid de type “ Cryocuff ” soit un pansement compressif de type Robert Jones . Le pansement froid a été utilisé 6 heures par jour pendant la durée de l'hospitalisation t and is que le pansement compressif de type Robert Jones a été laisse en place pendant 48 heures après l'opération . Aucune différence statistiquement significative n'a pu être mise en évidence entre les deux groupes , à l'exception des pertes sanguines dans le drainage , moins importantes dans le premier groupe de patients . Nous avons eu des complications post opératoires dans les deux groupes mais aucune corrélation n'a pu être établie entre ces complications et le type de b and age appliqué BACKGROUND AND PURPOSE Owing to a scarcity of clinical research , evidence -based clinical guidelines are not available to guide physiotherapy rehabilitation after total knee replacement surgery . This is despite the fact that , annually , over 20000 patients in Australia , over 300 000 patients in North America and 36 000 patients in the UK potentially require rehabilitation at this time to regain functional independence and to resume recreational and work-related physical activities . This survey of clinicians aim ed to describe st and ard ( usual ) care after total knee replacement in Australia and to provide possible explanations for practice variance , if such variation exists . METHOD A nationwide postal survey involving public and privately funded hospital physiotherapy departments was conducted . Purposive sampling was used to r and omly select hospitals from the National Joint Replacement Registry . A series of closed and open-ended protocol -based questions were asked . RESULTS A response rate of 65 % ( 65/100 ) was obtained . Elements of consistency and diversity across the acute and post-acute phases were evident . Consistent findings included the provision of gait retraining and exercise prescription in the acute period , the requirement for independent ambulation as a criterion for discharge from acute care and the routine referral to ongoing outpatient or community-based physiotherapy . Less consistency was reported for the use of continuous passive motion and cryotherapy in the acute phase , the modes of ongoing rehabilitation , discharge from rehabilitation criteria and the tools for measuring outcomes . Both institutional and non-institutional factors appeared to explain the demonstrated practice variation . CONCLUSIONS In order to propagate evidence -based practice guidelines and uniformity in care , well- design ed clinical trials are required to identify cost-effective rehabilitation programmes after total knee replacement Three rehabilitation modalities relating to in-hospital postoperative care following unilateral total knee arthroplasty ( UTKA ) were studied regarding their effect on pain management and UTKA outcome : ( 1 ) continuous passive motion ( CPM ) ; ( 2 ) CPM with transcutaneous electrical nerve stimulation ( TENS ) ; and ( 3 ) CPM with continuous cooling pad ( CCP ) . Phase I : CPM . Twenty-two UTKA patients were r and omized into two postoperative care groups : ( 1 ) 12 with CPM ; and ( 2 ) 10 with no CPM . Total hospitalization pain medication consumption was significantly less for the CPM group ( P less than .05 ) . Phase II : CPM With TENS . Forty-eight UTKA patients were r and omized into three postoperative care groups : ( 1 ) 18 with an ipsilateral thigh TENS unit delivering sensory threshold stimulation ; ( 2 ) 18 with a subthreshold TENS unit ; and ( 3 ) 12 with no TENS unit . All groups used CPM . No significant difference was found regarding pain medication consumption . Phase III : CPM With CCP . Thirty consecutive UTKA patients were divided into two postoperative care groups : ( 1 ) 15 with a CCP unit ; and ( 2 ) 15 with no CCP unit . Both groups used CPM . No significant difference was found regarding total or intramuscular hospitalization pain medication consumption . However , oral hospitalization pain medication consumption was significantly less for the CCP group ( P less than .01 ) . This postoperative UTKA study demonstrates significantly decreased total in-hospital pain medication consumption when comparing CPM vs no CPM , significantly decreased oral in-hospital pain medication consumption when comparing CPM with CCP vs CPM without CCP , but no difference when comparing CPM with TENS vs CPM without TENS . ( ABSTRACT TRUNCATED AT 250 WORDS Fifty total hip arthroplasty ( THA ) patients and 24 total knee arthroplasty ( TKA ) patients were r and omized in a controlled study to examine the effects of cold therapy ( via thermal blankets ) in the postoperative period . The postoperative hospital stay was significantly shorter for the cold-therapy ( 50 degrees F ) compared with control ( 70 degrees F ) groups ( by 1.4 days , P = 0.03 ) for THA patients . There was a similar but nonsignificant trend observed in the TKA groups ( 1.5 days shorter , P = 0.19 ) . Total knee arthroplasty patients using cold therapy achieved independent ambulation an average of 1 day sooner than TKA control patients , but this difference did not reach statistical significance ( P = 0.08 ) . There were no statistically significant differences between the control groups or the test groups for both THA and TKA patients in narcotic usage , postoperative range-of-motion ( ROM ) , or rate of progression of ROM Most literature reporting the impressive results from knee and hip replacement derives from international data . Few Australian studies have comprehensively compared outcomes after joint replacement up to 1 year . This paper compares the patterns of recovery across physical and patient-centred outcomes following knee or hip replacement in an Australian cohort . One hundred and twenty-two consecutive patients undergoing knee or hip replacement were prospect ively followed . Serial assessment s were conducted ( preoperatively , and 2 , 6 , 12 , 26 and 52 weeks post-surgery ) . Joint pain , patient 's global improvement , timed mobility , and complications were monitored . English-proficient patients completed WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index ) and SF-36v2 ( Medical Outcomes Short-Form 36 version 2 ) question naires . At 1 year , 81 % ( 55 knee , 44 hip ) were available for follow-up . Significant , large improvements ( up to 254 % ) were evident for most outcomes . Global improvement was reported by 97 % . Recovery for both surgical groups was greatest within the first 26 weeks , but hip patients improved more quickly in most outcomes . Wound disturbances were the most common complication ( 23 in total , 23 % ) and 13 patients ( 13 % ) were readmitted for complications . Recovery patterns were similar to that observed elsewhere . The physical and patient-centred outcomes provide a useful Australian reference for clinicians of the temporal aspects of recovery as well the differences between hip and knee surgeries . Complication and readmission rates appeared high , possibly partly explained by the rigorous capture method Cryotherapy is a common modality used after arthroscopic procedures . The current authors investigated whether regions deeper than the lateral gutter experience similar temperature reductions with cryotherapy , supporting a more global temperature effect on the synovium . Thermocouple probes were arthroscopically placed intraarticularly in the medial gutter and suprapatellar pouch after routine knee arthroscopy . Twelve patients were divided into two groups for temperature measurement during 2 hours . Ice was applied only for the first hour in Group 1 ( n = 6 ) and only for the second hour in Group 2 ( n = 6 ) . The medial gutter and suprapatellar pouch had significant decreases ( average , 2.7 ° –5 ° C ) in the temperature when ice was applied and a significant increase ( average , 1.7 ° –3 ° C ) in the temperature without ice . Also , the temperatures in the medial gutter and suprapatellar pouch correlated with each other . At 1 hour , the mean difference between ice versus no ice was on average 6 ° C. Cryotherapy globally decreased intraarticular temperature in the absence of hemarthrosis Of all arthroscopic procedures , lateral retinacular release carries the greatest potential for morbidity . Complication rates of up to 7.2 % have been reported , secondary to intraoperative and postoperative hematoma formation . A prospect i ve double-blind study was conducted in which patients were r and omly assigned to one of two groups treated with or without cold therapy for 24 hours postoperatively , subsequent to arthroscopic lateral retinacular release utilizing electrosurgery . Seventy-four percent of the patients treated with cold therapy had good to excellent results postoperatively , and none had significant complications . Thirty-two percent of the patients treated without cold therapy had good to excellent results postoperatively , and two patients experienced significant complications in this group In spite of its widespread use after orthopaedic procedures , the literature evaluating the clinical efficacy of cryotherapy is controversial . The purpose of this prospect i ve r and omized trial was to compare two different temperatures for administering cryotherapy after total knee arthroplasty with regards to short-term postoperative outcomes . Sixty-four subjects were assigned either the 45 degrees F group or the 75 degrees F group . Subjects in the 45 degrees group were as likely to report a lower pain score at the time of follow-up compared to the 75 degrees group . Our results demonstrate no additional analgesic effect associated with the lower temperature of cryotherapy . Postoperative narcotic consumption , postoperative drainage , self-reported knee function , and range of motion were not affected by the different cryotherapy temperatures . No adverse effects were reported with the cryotherapy treatment OBJECTIVE Increasing attention has been given to the assessment of patient satisfaction as a way to monitor quality of care in hospital setting s. Postoperative patient satisfaction has been thought to be related to level of pain intensity , expectations of outcome , perceived concern by the staff , and helpfulness of treatments . The aim of this study is to develop a simple , reliable measure to assess pain and satisfaction in postsurgical patients and to examine factors related to patient satisfaction . DESIGN A satisfaction question naire was developed for this study and administered to 119 patients who had undergone a major orthopedic surgical procedure . The majority of the patients were diagnosed with osteoarthritis and reported moderate to severe preoperative pain . The 13-item measure was found to be reliable ( test-retest r = .86 ; interexaminer r = .98 ) , valid ( exploratory factor analyses ; intercorrelations ) , and easy to administer . RESULTS Results showed that the majority of the patients were satisfied with their care ( 91 % ) , postoperative pain intensity ( 94 % ) , and the way they were treated by the physicians and nurses ( 98 % ) . Patients with low postoperative pain ratings who perceived that the physicians and nurses showed concern with how much pain they were feeling reported greatest satisfaction with their care ( p < .001 ) . In general , lower postoperative pain ratings were the best predictors of satisfaction and helpfulness of treatment . Preoperative pain status , expected level of postoperative pain , and time waiting for pain medication after a request was made were not significantly correlated with ratings of postoperative pain or satisfaction . CONCLUSIONS These results highlight the important influence of adequate treatment of postoperative pain and perceived concern by the hospital staff on patient satisfaction Ninety consecutive patients undergoing primary knee arthroplasty received local cryotherapy 72 hours after surgery for pain relief . Thermal-pad circulating temperatures were r and omly assigned to 50 degrees , 60 degrees , or 70 degrees F ( room temperature ) . Pain relief was monitored using patient-controlled analgesia machines . The amount of morphine received and number of attempts per hour were statistically analyzed with relation to temperature group , age , sex , weight , side , and diagnosis . The amount of morphine injected was positively correlated to the number of attempts per hour and moderately correlated to body weight . There was no correlation between thermal-pad temperature or any other parameter and the amount of morphine injected after surgery The efficacy of a cold compressive dressing after total knee arthroplasty ( TKA ) was prospect ively studied in 105 knees in 76 patients . All components were cemented . All patients were placed in continuous passive motion machines after operation . A cold compressive Cryocuff dressing was applied to 50 knees after operation
Output:
| Cryotherapy result ed in small benefits in blood loss and discharge knee range of motion .
There were no benefits in transfusion and analgesia requirements , pain , swelling , length of stay , and gains in knee range of motion after discharge .
Despite some early gains , cryotherapy after TKA yields no apparent lasting benefits .
The current evidence does not support the routine use of cryotherapy after TKA |
MS213169 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: OBJECTIVE To assess the impact of a school-based nutrition education intervention aim ed at increasing the consumption of fruits and vegetables . DESIGN The intervention programme increased the provision of fruits and vegetables in schools and provided a range of point-of-purchase marketing material s , newsletters for children and parents , and teacher information . Curriculum material s at age 6 - 7 and 10 - 11 years were also developed and utilised . Evaluation was undertaken with groups of younger ( aged 6 - 7 years ) and older ( aged 10 - 11 years ) children . Methods included 3-day dietary records with interview and cognitive and attitudinal measures at baseline , with follow-up at 9 months , in intervention and control schools . SETTING The work was undertaken in primary schools in Dundee , Scotl and . SUBJECTS Subjects comprised 511 children in two intervention schools with a further 464 children from two schools acting as controls . RESULTS Children ( n=64 ) in the intervention schools had an average increase in fruit intake ( 133+/-1.9 to 183+/-17.0 g day(-1 ) ) that was significantly ( P<0.05 ) greater than the increase ( 100+/-11.7 to 107+/-14.2 g day(-1 ) ) estimated in children ( n=65 ) in control schools . No other changes in food or nutrient intake were detected . Increases in scores for variables relating to knowledge about fruits and vegetables and subjective norms were also greater in the intervention than in the control group , although taste preferences for fruits and vegetables were unchanged . CONCLUSIONS It is concluded that a whole school approach to increasing intakes of fruits and vegetables has a modest but significant effect on cognitive and attitudinal variables and on fruit intake BACKGROUND The consumption of beverages that contain sugar is associated with overweight , possibly because liquid sugars do not lead to a sense of satiety , so the consumption of other foods is not reduced . However , data are lacking to show that the replacement of sugar-containing beverages with noncaloric beverages diminishes weight gain . METHODS We conducted an 18-month trial involving 641 primarily normal-weight children from 4 years 10 months to 11 years 11 months of age . Participants were r and omly assigned to receive 250 ml ( 8 oz ) per day of a sugar-free , artificially sweetened beverage ( sugar-free group ) or a similar sugar-containing beverage that provided 104 kcal ( sugar group ) . Beverages were distributed through schools . At 18 months , 26 % of the children had stopped consuming the beverages ; the data from children who did not complete the study were imputed . RESULTS The z score for the body-mass index ( BMI , the weight in kilograms divided by the square of the height in meters ) increased on average by 0.02 SD units in the sugar-free group and by 0.15 SD units in the sugar group ; the 95 % confidence interval ( CI ) of the difference was -0.21 to -0.05 . Weight increased by 6.35 kg in the sugar-free group as compared with 7.37 kg in the sugar group ( 95 % CI for the difference , -1.54 to -0.48 ) . The skinfold-thickness measurements , waist-to-height ratio , and fat mass also increased significantly less in the sugar-free group . Adverse events were minor . When we combined measurements at 18 months in 136 children who had discontinued the study with those in 477 children who completed the study , the BMI z score increased by 0.06 SD units in the sugar-free group and by 0.12 SD units in the sugar group ( P=0.06 ) . CONCLUSIONS Masked replacement of sugar-containing beverages with noncaloric beverages reduced weight gain and fat accumulation in normal-weight children . ( Funded by the Netherl and s Organization for Health Research and Development and others ; DRINK Clinical Trials.gov number , NCT00893529 . ) Objective : To assess the efficacy of a school-based intervention programme to reduce the prevalence of overweight in 6 to 10-year-old children . Design : Cluster-r and omized , controlled study .Subjects : A total of 3135 boys and girls in grade s 1–4 were included in the study . Methods : Ten schools were selected in Stockholm county area and r and omized to intervention ( n=5 ) and control ( n=5 ) schools . Low-fat dairy products and whole-grain bread were promoted and all sweets and sweetened drinks were eliminated in intervention schools . Physical activity ( PA ) was aim ed to increase by 30 min day−1 during school time and sedentary behaviour restricted during after school care time . PA was measured by accelerometry . Eating habits at home were assessed by parental report . Eating disorders were evaluated by self-report . Results : The prevalence of overweight and obesity decreased by 3.2 % ( from 20.3 to 17.1 ) in intervention schools compared with an increase of 2.8 % ( from 16.1 to 18.9 ) in control schools ( P<0.05 ) . The results showed no difference between intervention and controls , after cluster adjustment , in the longitudinal analysis of BMI sds changes . However , a larger proportion of the children who were initially overweight reached normal weight in the intervention group ( 14 % ) compared with the control group ( 7.5 % ) , P=0.017 . PA did not differ between intervention and control schools after cluster adjustment . Eating habits at home were found to be healthier among families with children in intervention schools at the end of the intervention . There was no difference between children in intervention and control schools in self-reported eating disorders . Conclusions : A school-based intervention can reduce the prevalence of overweight and obesity in 6 to 10-year-old children and may affect eating habits at home . The effect of the intervention was possibly due to its effect on healthy eating habits at school and at home rather than on increased levels of PA OBJECTIVE To examine change in high school students ' beverage consumption patterns pre- and post-intervention of reduced availability of sugar-sweetened beverages ( SSB ) and diet soda in school food venues . DESIGN A prospect i ve , quasi-experimental , nonr and omized study design . SETTING Public high schools . PARTICIPANTS A convenience sample from control ( n = 221 ) and intervention ( n = 235 ) high schools . INTERVENTION Schools aim ed to reduce ( n = 4 ) or not change ( n = 3 ) availability of SSB and diet soda in food venues for 1 school year . MAIN OUTCOME MEASURES Subjects ' beverage servings/day was determined from a food frequency question naire pre- and post-intervention . ANALYSIS Two-by-two mixed analysis of variance model compared pre- to post-intervention servings/day between control and intervention subjects , stratified by gender . RESULTS Consumption of SSB decreased in both intervention and control boys ( F = 53.69 , P < .05 ) and girls ( F = 22.87 , P < .05 ) . Intervention girls decreased diet soda consumption as compared to control girls ( F = 6.57 , P < .05 ) . CONCLUSION AND IMPLICATION S Reducing availability of SSB in schools did not result in a greater decrease in SSB consumption by intervention as compared to control subjects . The impact of reducing availability of SSB at school may be limited . A better underst and ing of beverage consumption patterns may be needed to determine the efficacy of school food policies on those youth susceptible to obesity BACKGROUND . The prevalence and seriousness of childhood obesity has prompted calls for broad public health solutions that reach beyond clinic setting s. Schools are ideal setting s for population -based interventions to address obesity . OBJECTIVE . The purpose of this work was to examine the effects of a multicomponent , School Nutrition Policy Initiative on the prevention of overweight ( 85.0th to 94.9th percentile ) and obesity ( > 95.0th percentile ) among children in grade s 4 through 6 over a 2-year period . METHODS . Participants were 1349 students in grade s 4 through 6 from 10 schools in a US city in the Mid-Atlantic region with ≥50 % of students eligible for free or reduced-price meals . Schools were matched on school size and type of food service and r and omly assigned to intervention or control . Students were assessed at baseline and again after 2 years . The School Nutrition Policy Initiative included the following components : school self- assessment , nutrition education , nutrition policy , social marketing , and parent outreach . RESULTS . The incidences of overweight and obesity after 2 years were primary outcomes . The prevalence and remission of overweight and obesity , BMI z score , total energy and fat intake , fruit and vegetable consumption , body dissatisfaction , and hours of activity and inactivity were secondary outcomes . The intervention result ed in a 50 % reduction in the incidence of overweight . Significantly fewer children in the intervention schools ( 7.5 % ) than in the control schools ( 14.9 % ) became overweight after 2 years . The prevalence of overweight was lower in the intervention schools . No differences were observed in the incidence or prevalence of obesity or in the remission of overweight or obesity at 2 years . CONCLUSION . A multicomponent school-based intervention can be effective in preventing the development of overweight among children in grade s 4 through 6 in urban public schools with a high proportion of children eligible for free and reduced-priced school meals BACKGROUND Consumption of sugar-sweetened beverages may cause excessive weight gain . We aim ed to assess the effect on weight gain of an intervention that included the provision of noncaloric beverages at home for overweight and obese adolescents . METHODS We r and omly assigned 224 overweight and obese adolescents who regularly consumed sugar-sweetened beverages to experimental and control groups . The experimental group received a 1-year intervention design ed to decrease consumption of sugar-sweetened beverages , with follow-up for an additional year without intervention . We hypothesized that the experimental group would gain weight at a slower rate than the control group . RESULTS Retention rates were 97 % at 1 year and 93 % at 2 years . Reported consumption of sugar-sweetened beverages was similar at baseline in the experimental and control groups ( 1.7 servings per day ) , declined to nearly 0 in the experimental group at 1 year , and remained lower in the experimental group than in the control group at 2 years . The primary outcome , the change in mean body-mass index ( BMI , the weight in kilograms divided by the square of the height in meters ) at 2 years , did not differ significantly between the two groups ( change in experimental group minus change in control group , -0.3 ; P=0.46 ) . At 1 year , however , there were significant between-group differences for changes in BMI ( -0.57 , P=0.045 ) and weight ( -1.9 kg , P=0.04 ) . We found evidence of effect modification according to ethnic group at 1 year ( P=0.04 ) and 2 years ( P=0.01 ) . In a prespecified analysis according to ethnic group , among Hispanic participants ( 27 in the experimental group and 19 in the control group ) , there was a significant between-group difference in the change in BMI at 1 year ( -1.79 , P=0.007 ) and 2 years ( -2.35 , P=0.01 ) , but not among non-Hispanic participants ( P>0.35 at years 1 and 2 ) . The change in body fat as a percentage of total weight did not differ significantly between groups at 2 years ( -0.5 % , P=0.40 ) . There were no adverse events related to study participation . CONCLUSIONS Among overweight and obese adolescents , the increase in BMI was smaller in the experimental group than in the control group after a 1-year intervention design ed to reduce consumption of sugar-sweetened beverages , but not at the 2-year follow-up ( the prespecified primary outcome ) . ( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; Clinical Trials.gov number , NCT00381160 . ) Objective The objective of this study is to assess population -level trends in children 's dietary intake and weight status before and after the implementation of a provincial school nutrition policy in the province of Nova Scotia , Canada . Method Self-reported dietary behavior and nutrient intake and measured body mass index were collected as part of a population -level study with grade 5 students in 2003 ( n = 5215 ) and 2011 ( 5508 ) , prior to and following implementation of the policy . We applied r and om effects regression methods to assess the effect of the policy on dietary and health outcomes . Results In 2011 , students reported consuming more milk products , while there was no difference in mean consumption of vegetables and fruits in adjusted models . Adjusted regression analysis revealed a statistically significant decrease in sugar-sweetened beverage consumption . Despite significant temporal decreases in dietary energy intake and increases in diet quality , prevalence rates of overweight and obesity continued to increase . Conclusion This population -level intervention research suggests a positive influence of school nutrition policies on diet quality , energy intake and healthy beverage consumption , and that more action beyond schools is needed to curb the increases in the prevalence of childhood obesity The aim of this study was to evaluate and compare the effectiveness of two primary school-based interventions on children 's fruit and vegetable ( F&V ) consumption on the long term ( 2 years after the start of the interventions ) . Six primary
Output:
| Conclusion National school F&V provision and SSB restriction policies implemented in elementary , middle , and high schools could improve diet and BMI in children and reduce CMD mortality later in life |
MS213170 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: A prospect i ve study of 110 unselected patients with suspected acute appendicitis comprised ultrasonography and parameters of inflammation -- c-reactive protein , white blood cell count , erythrocyte sedimentation rate and Yersinia antibody titer . The results were compared with the initial clinical diagnosis . Acute appendicitis was confirmed in 28 cases ( prevalence 25.4 % ) . The negative laparotomy rate was 11.4 % and the appendiceal perforation rate 10.7 % Clinical judgment and ultrasonography were statistically highly significant as predictors of acute appendicitis , whereas the indications given by c-reactive protein and white blood cell count did not reach statistical significance Headache following lumbar puncture is a well known and well described complication . Various manoeuvres have been tried to prevent post lumbar puncture headache -- the commonest being bed rest for 4 to 24 hours following lumbar puncture , though its value is question able . R and omised controlled clinical trial was done to evaluate the effect of 24 hours bed rest on the incidence and severity of post lumbar puncture headaches . Two hundred and eight patients were r and omly allocated to either the ambulant or the bed rest group . Patients were interviewed by a single investigator on days 0 , 1 , 2 and 7 about the presence and nature of headache . Other relevant clinical and laboratory data pertaining to the lumbar puncture was collected . The overall incidence of post lumbar puncture headache was 17 % ; 15 % in the ambulant and 18 % in the bed rest group . Of the patients who had headaches , severe headache was observed in 57 % in the ambulant and 12 % in the bed rest group ( p = 0.02 ) . Other variables did not alter the outcome of headaches . Bed rest does not appear to alter the incidence of post lumbar puncture headaches , but reduces the severity in those who get headaches , after a lumbar puncture The diagnostic value of C-reactive protein ( CRP ) , total white blood cell ( WBC ) count , total neutrophil count , and neutrophil differential count were evaluated in a prospect i ve blinded study of 204 patients su bmi tted with the tentative diagnosis of acute appendicitis . The laboratory tests were performed on blood sample s obtained at the time of admission , and the results were stored until the patients were discharged . One hundred patients were operated on : 59 had appendicitis , 3 had other surgically correctable diseases , and 38 had a superfluous exploration . All 104 nonoperated patients recovered spontaneously . The sensitivity , specificity , and predictive values of single tests and test combinations were calculated at different cutoff levels . Using st and ard reference intervals , WBC count demonstrated the best sensitivity ( 83 percent ) and predictive value of a negative result ( 88 percent ) . Combining the tests by an “ or ” rule enhanced the sensitivity to 100 percent , employing WBC count or CRP or neutrophil percentage above the reference range ( triple test ) , but at the expense of the predictive value of a positive test ( 37 percent ) . It was concluded that both single tests and combined tests are of limited value in predicting acute appendicitis . However , the same triple test combination proved a predictive value of a negative result at 100 percent ( 95 percent confidence limits 92 to 100 percent ) , indicating that acute appendicitis is unlikely when these tests are simultaneously negative . The triple test combination was valid in 32 percent of the patients who were free from appendicitis . In the study group , 10 of the patients ( 25 percent ) who had a superfluous exploration had a negative triple test , and they might have avoided surgery if it had been used . Therefore , the triple test is recommended as a help in reducing the significant rate of negative laparotomies in patients suspected of having acute appendicitis The clinical diagnosis of appendicitis needs to be improved , as up to 40 % of explorations for suspected appendicitis are unnecessary . The use of body temperature and laboratory examinations as diagnostic aids in the management of these patients is controversial . The diagnostic power of these variables compared to that of the disease history and clinical findings is not well studied . In this study we prospect ively assessed and compared the diagnostic value of 21 elements of the history , clinical findings , body temperature , and laboratory examinations in 496 patients with suspected appendicitis . The diagnostic value of each variable was compared from the area under the receiver operating characteristic ( ROC ) curve and the likelihood ratios ( LR ) . Logistic regression was used to analyze the diagnostic value of a combination of variables and to analyze independent relations . No single variable had sufficiently high discriminating or predicting power to be used as a true diagnostic test . The inflammatory variables ( temperature , leukocyte and differential white blood cell ( WBC ) counts , C-reactive protein ) had discriminating and predicting powers similar to those of the clinical findings ( direct and rebound abdominal tenderness and guarding ) . Anorexia , nausea , and right-sided rectal tenderness had no diagnostic value . The leukocyte and differential WBC counts , C-reactive protein , rebound tenderness , guarding , and gender were independent predictors of appendicitis with a combined ROC area of 0 . 93 for appendicitis . This showed that inflammatory variables contain important diagnostic information , especially with advanced appendicitis . They should therefore always be included in the diagnostic workup in patients with suspected appendicitis The total leucocyte count ( TLC ) and neutrophil percentage ( NP ) were studied prospect ively in 1032 patients who underwent appendicectomy for suspected acute appendicitis . On histopathological study of the resected appendices , 97 patients had normal appendices , and 935 patients had acutely inflamed , gangrenous or perforated appendicitis . Statistically more patients with appendicitis had either raised TLC or raised NP compared with patients with normal appendices ( P less than 0.001 ) , and also compared with 357 patients who were admitted with right lower quadrant abdominal pain but were not subjected to operation ( P less than 0.001 ) . The sensitivity and specificity of raised TLC in diagnosing appendicitis for patients who underwent appendicectomy were 81.4 % and 77.3 % , respectively . Sensitivity increased when either raised TLC or raised NP were used , but specificity decreased . In contrast , sensitivity decreased when both raised TLC and raised NP were used together , but specificity increased . Raised TLC , preferably combined with raised NP , is a useful diagnostic aid in acute appendicitis . The TLC and NP , however , should only be interpreted in the light of physical findings in patients with suspected appendicitis because these blood tests have false positive and false negative results In this single-blind , r and omized study of post-lumbar-puncture headache ( PPH ) in 300 neurologic in patients the significance of body posture after lumbar puncture ( LP ) was evaluated . Immediate mobilization was compared with bed rest for 6 h ( 3 h prone followed by 3 h supine posture ) . Contrary to the widely held belief , this investigation did not show significant differences between recumbent and ambulant patients as to frequency of PPH in the total material ( 39 % versus 35 % ) or when men ( 31 % versus 29 % ) and women ( 48 % versus 41 % ) were evaluated separately . Headache associated with nausea was significantly more frequent in the recumbent than in the ambulant patients both in the total material ( 23 % versus 13 % ) and in women ( 35 % versus 16 % ) . Thus , immediate mobilization seems to be preferable after LP A r and omised study was carried out to compare the efficacy of the gum elastic bougie and the stylet in a simulated difficult intubation . A laryngoscopy assessment , as described by Cormack and Lehane , was made in 100 patients . A Grade 3 view was then simulated . In the Bougie First Group ( 50 patients ) two attempts were made to pass a gum elastic bougie and a tracheal tube into the trachea . If these first two attempts were not successful , two further attempts at intubation were allowed with a stylet placed in the tracheal tube . In the Stylet First Group ( 50 patients ) the order was reversed . After two attempts the tube was correctly placed in the trachea in 96 % of cases in the Bougie First Group compared to only 66 % of cases in the Stylet First Group ( p < 0.001 ) . We recommend that a gum elastic bougie should be readily available and that anaesthetists should use it in preference to a stylet whenever a good view of the glottis is not immediately available Abstract Lumbar puncture was performed on 100 neurological patients by one investigator , using one needle size . 50 patients were kept ambulant and the other 50 , who were comparable in age , sex , and neuroticism , were given 24 hours ' bed rest . The incidence of post-lumbar-puncture headache did not differ significantly between the two groups A r and omized study of 110 patients undergoing their first diagnostic lumbar puncture was performed to compare the effect of immediate mobilization with 4 hours bed rest on the incidence of post lumbar puncture headache . There was no difference between the mobile ( n = 54 ) and bed rest ( n = 56 ) groups in the incidence of post lumbar puncture headache ( 32 % versus 31 % , respectively ) . We conclude that bed rest following lumbar puncture may be an unnecessary imposition on the patient , as well as on nursing staff
Output:
| Comment(s ) No papers were found that involved physiotherapy treatment of Bell ’s palsy in the acute setting .
The above paper describes significant differences in the outcomes used for patients with long term facial nerve palsy using electrical stimulation , however this was not a rigorous study .
c CLINICAL BOTTOM LINE There is no evidence to suggest that either exercises or electrical stimulation is beneficial to patients with acute Bell ’s palsy .
Evidence does exist to justify the use of electrical stimulation in patients with long term Bell ’s palsy , although the study could have been more rigorous .
Clinical Rehabilitation 1987;1:265–71 .
bestbets.org : Odds on favourite for evidence in emergency medicine reaches the worldwide web . |
MS213171 | ***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: Background Gastrojejunostomy ( GJJ ) and stent placement are the most commonly used palliative treatments for malignant gastric outlet obstruction ( GOO ) . In a recent r and omized trial , stent placement was preferred in patients with a relatively short survival and GJJ in patients with a longer survival . As health economic aspects have only been studied in general terms , we estimated the cost of GJJ and that of stent placement in such patients . Methods In the SUSTENT study , patients were r and omized to GJJ ( n = 18 ) or stent placement ( n = 21 ) . Pancreatic cancer was the most common cause of GOO . We compared initial costs and costs during follow-up . For cost-effectiveness , the incremental cost-effectiveness ratio was calculated . Results Food intake improved more rapidly after stent placement than after GJJ , but long-term relief of obstructive symptoms was better after GJJ . More major complications ( P = 0.02 ) occurred and more re interventions were performed ( P < 0.01 ) after stent placement than after GJJ . Initial costs were higher for GJJ compared to stent placement ( € 8315 vs. € 4820 , P < 0.001 ) . We found no difference in follow-up costs . Total costs per patient were higher for GJJ compared to stent placement ( € 12433 vs. € 8819 , P = 0.049 ) . The incremental cost-effectiveness ratio of GJJ compared to stent placement was € 164 per extra day with a gastric outlet obstruction scoring system ( GOOSS ) ≥2 adjusted for survival . Conclusions Medical effects were better after GJJ , although GJJ had higher total costs . Since the cost difference between the two treatments was only small , cost should not play a predominant role when deciding on the type of treatment assigned to patients with malignant GOO ( IS RCT N 06702358 ) Background Gastric outlet obstruction poses diagnostic and therapeutic challenges to general surgeons practicing in re source -limited countries . There is a paucity of published data on this subject in our setting . This study was undertaken to highlight the etiological spectrum and treatment outcome of gastric outlet obstruction in our setting and to identify prognostic factors for morbidity and mortality . Methods This was a descriptive prospect i ve study which was conducted at Bug and o Medical Centre between March 2009 and February 2013 . All patients with a clinical diagnosis of gastric outlet obstruction were , after informed consent for the study , consecutively enrolled into the study . Statistical data analysis was done using SPSS computer software version 17.0 . Results A total of 184 patients were studied . More than two-third of patients were males . Patients with malignant gastric outlet obstruction were older than those of benign type . This difference was statistically significant ( p < 0.001 ) . Gastric cancer was the commonest malignant cause of gastric outlet obstruction where as peptic ulcer disease was the commonest benign cause . In children , the commonest cause of gastric outlet obstruction was congenital pyloric stenosis ( 13.0 % ) . Non-bilious vomiting ( 100 % ) and weight loss ( 93.5 % ) were the most frequent symptoms . Eighteen ( 9.8 % ) patients were HIV positive with the median CD 4 + count of 282 cells/μl . A total of 168 ( 91.3 % ) patients underwent surgery . Of these , gastro-jejunostomy ( 61.9 % ) was the most common surgical procedure performed . The complication rate was 32.1 % mainly surgical site infections ( 38.2 % ) . The median hospital stay and mortality rate were 14 days and 18.5 % respectively . The presence of postoperative complication was the main predictor of hospital stay ( p = 0.002 ) , whereas the age > 60 years , co-existing medical illness , malignant cause , HIV positivity , low CD 4 count ( < 200 cells/μl ) , high ASA class and presence of surgical site infection significantly predicted mortality ( p < 0.001 ) . The follow up of patients was generally poor as more than 60 % of patients were lost to follow up . Conclusion Gastric outlet obstruction in our setting is more prevalent in males and the cause is mostly malignant . The majority of patients present late with poor general condition . Early recognition of the diagnosis , aggressive resuscitation and early institution of surgical management is of paramount importance if morbidity and mortality associated with gastric outlet obstruction are to be avoided Background We prospect ively compared laparoscopic gastrojejunostomy with duodenal stenting as a means of palliating malignant gastric outflow obstruction . Methods A total of 27 patients with malignant gastric outflow obstruction were r and omized to either laparoscopic gastrojejunostomy ( LGJ ) or duodenal stenting ( DS ) over a 3-year period . Results Thirteen patients underwent successful LGJ and 10 had successful DS . Eight patients had complications after LGJ , but none had complications after DS . Patients who underwent LGJ had a significant increase in visual analog pain score at day 1 ( p = 0.05 ) , and also had a longer hospital stay compared to those who underwent DS ( 11.4 vs. 5.2 days , p = 0.02 ) . After DS , patients experienced an improvement in physical health at 1 month as measured using the Short Form-36 ( SF-36 ) question naire ( p < 0.01 ) . There was no change following LGJ . Conclusion Duodenal stenting is a safe means of palliating malignant gastric outflow obstruction . It offers significant advantages for patients compared with minimal-access surgery BACKGROUND Both gastrojejunostomy ( GJJ ) and stent placement are commonly used palliative treatments of obstructive symptoms caused by malignant gastric outlet obstruction ( GOO ) . OBJECTIVE Compare GJJ and stent placement . DESIGN Multicenter , r and omized trial . SETTING Twenty-one centers in The Netherl and s. PATIENTS Patients with GOO . INTERVENTIONS GJJ and stent placement . MAIN OUTCOME MEASUREMENTS Outcomes were medical effects , quality of life , and costs . Analysis was by intent to treat . RESULTS Eighteen patients were r and omized to GJJ and 21 to stent placement . Food intake improved more rapidly after stent placement than after GJJ ( GOO Scoring System score > or = 2 : median 5 vs 8 days , respectively ; P < .01 ) but long-term relief was better after GJJ , with more patients living more days with a GOO Scoring System score of 2 or more than after stent placement ( 72 vs 50 days , respectively ; P = .05 ) . More major complications ( stent : 6 in 4 patients vs GJJ : 0 ; P = .02 ) , recurrent obstructive symptoms ( stent : 8 in 5 patients vs GJJ : 1 in 1 patient ; P = .02 ) , and re interventions ( stent : 10 in 7 patients vs GJJ : 2 in 2 patients ; P < .01 ) were observed after stent placement compared with GJJ . When stent obstruction was not regarded as a major complication , no differences in complications were found ( P = .4 ) . There were also no differences in median survival ( stent : 56 days vs GJJ : 78 days ) and quality of life . Mean total costs of GJJ were higher compared with stent placement ( $ 16,535 vs $ 11,720 , respectively ; P = .049 [ comparing medians ] ) . Because of the small study population , only initial hospital costs would have been statistically significant if the Bonferroni correction for multiple testing had been applied . LIMITATIONS Relatively small patient population . CONCLUSIONS Despite slow initial symptom improvement , GJJ was associated with better long-term results and is therefore the treatment of choice in patients with a life expectancy of 2 months or longer . Because stent placement was associated with better short-term outcomes , this treatment is preferable for patients expected to live less than 2 months . ( CLINICAL TRIAL REGISTRATION NUMBER IS RCT N 06702358 . ) BACKGROUND Gastroenterostomy was the palliative treatment of choice in patients with malignant unresectable gastric outlet obstruction . Palliative endoscopic treatment of malignant gastric outlet obstruction with endoluminal self-exp and ing metallic stents is nowadays a well-established procedure . PATIENTS AND METHODS Eighteen patients referred for treatment with diagnosis of malignant strictures of the antro-pyloric tract presenting at an advanced unresectable stage . The patients were r and omly assigned into two treatment groups ( endoscopic vs. surgery ) according to r and om-number tables . The length of procedure , morbidity and mortality rate , restoration of oral intake and gastric emptying at 8 , 15 days and 3 months from treatment and hospital stay were assessed . RESULTS Endoscopic group : The median length of procedure was 40 minutes . No death and one minor complication ( 11.1 % ) was reported . Mean time for oral intake was 2.1 days . Gastric emptying was satisfactory in 88.9 % after 8 days and in 100 % of patients after 15 days and 3 months . The median hospital stay was 3.1 days . Surgery group : The median length of the operation was 93 minutes . No mortality was reported . One patient ( 11.1 % ) developed anastomotic bleeding which required relaparotomy . Mean time for oral intake was 6.3 days . Gastric emptying was satisfactory in 66.7 % of patients after 8 days , in 88.9 % after 15 days and in 100 % after 3 months . The median hospital stay was 10 days . CONCLUSION There were no statistically significant differences between the 2 groups even with respect to morbidity , mortality , delayed gastric emptying and clinical outcomes at 3-month follow-up . Endoscopic stenting was significantly more effective with respect to operative time , restoration of oral intake and median hospitalization . Our results would suggest that endoscopically placed metal stents offer an effective alternative to surgical palliation in patients with unresectable malignant strictures BACKGROUND Gastrojejunostomy and stentplacement are the most commonly used treatments for malignant gastric outlet obstruction ( GOO ) . The preference for either treatment largely depends on the expected survival . Our objective was to investigate predictors of survival in patients with malignant GOO and to develop a model that could aid in the decision for either gastrojejunostomy or stentplacement . METHODS Prognostic factors for survival were collected from a literature search and evaluated in our patient population , which included 95 retrospectively and 56 prospect ively followed cases . All 151 patients were treated with gastrojejunostomy or stentplacement . RESULTS A higher WHO performance score was the only significant prognostic factor for survival in our multivariable analysis ( HR 2.2 95%CI 1.7 - 2.9 ) , whereas treatment for obstructive jaundice , gender , age , metastases , weight loss , level of obstruction and pancreatic cancer were not . A prognostic model that includes the WHO score was able to distinguish patients with a poor survival ( WHO score 3 - 4 , median survival : 31 days ) from those with a relatively intermediate or good survival ( WHO score 2 , median survival : 69 and WHO score 0 - 1 , median survival : 139 days , respectively ) . CONCLUSIONS Only the WHO score is a significant predictor of survival in patients with malignant GOO . A simple prognostic model is able to guide the palliative treatment decision for either gastrojejunostomy ( WHO score 0 - 1 ) or stentplacement ( WHO 3 - 4 ) in patients with malignant GOO BACKGROUND Malignant gastric outlet obstruction is often treated by stent placement . OBJECTIVE To investigate the outcomes of stent placement in the palliative treatment of malignant neoplasms . DESIGN Prospect i ve , observational , multicenter registry . SETTING Six tertiary care centers in 5 countries . PATIENTS A total of 108 adult patients with malignant gastric outlet obstruction . INTERVENTIONS Placement of an uncovered , self-exp and able , metal duodenal stent . MAIN OUTCOME MEASUREMENTS The primary endpoint was stent patency at 14 days after stent implantation . Secondary endpoints included stent patency at 1 , 2 , 3 , and 6 months , gastric outlet obstruction scoring system ( GOOSS ) scores at 14 days and 1 , 2 , 3 , and 6 months after stent deployment , technical success , adverse events , and patient survival ( ie , confirmed duration of the implant ) . RESULTS Technical success was achieved in 99.1 % of stent placements . Stent patency at 14 days was 94.6 % . Kaplan-Meier estimates of stent patency were 92.9 % at 1 month , 86.2 % at 2 months , 81.9 % at 3 months , and 63.4 % at 6 months . At 14 days , GOOSS scores increased by a median of 1 point . The overall GI adverse event rate was 32.4 % ; however , the stent-related adverse event rate was 19.4 % . The median implant duration was 47 days ( range 0 -
Output:
| The meta- analysis of surgical and endoscopic stent treatment showed no difference in the technical success and overall number of complications .
Conclusions : In the palliation of malignant GOO , covered SEMS had higher migration and lower obstruction rates when compared with uncovered stents .
Surgery is associated with lower reintervention rates than stents |
MS213172 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: In three parallel groups , brief and intermittent administration and withdrawal of triazolam , 0.5 mg , temazepam , 30 mg , and placebo were assessed in a 12‐night sleep laboratory study of 18 subjects with insomnia . With this intermittent schedule both drugs improved sleep , with about a one‐third reduction in total wake time ; this reduction was significant for temazepam but not for triazolam . Even though the periods of drug administration were quite brief , withdrawal of triazolam consistently produced rebound insomnia , with increases in total wake time above baseline of 61 % and 51 % , respectively , for the first night of each withdrawal period . With temazepam this effect was more variable , with total wake time increased only with the second withdrawal period ( 39 % ) . Thus these findings indicate that even under conditions of brief , intermittent use and withdrawal , triazolam and , to a lesser degree , temazepam produce rebound insomnia after abrupt withdrawal , thereby predisposing to drug‐taking behavior and increasing the potential for drug dependence BACKGROUND In view of the high co-occurrence of depression and insomnia , a novel way to reduce the risk of escalating depression might be to offer an insomnia intervention . We aim ed to assess whether an online self-help insomnia program could reduce depression symptoms . METHODS We did this r and omised controlled trial at the Australian National University in Canberra , Australia . Internet users ( aged 18 - 64 years ) with insomnia and depression symptoms , but who did not meet criteria for major depressive disorder , were r and omly assigned ( 1:1 ) , via computer-generated r and omisation , to receive SHUTi , a 6 week , modular , online insomnia program based on cognitive behavioural therapy for insomnia , or HealthWatch , an interactive , attention-matched , internet-based placebo control program . R and omisation was stratified by age and sex . Telephone-based interviewers , statisticians , and chief investigators were masked to group allocation . The primary outcome was depression symptoms at 6 months , as measured with the Patient Health Question naire ( PHQ-9 ) . The primary analysis was by intention to treat . This trial is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12611000121965 . FINDINGS Between April 30 , 2013 , and June 9 , 2014 , we r and omly assigned 1149 participants to receive SHUTi ( n=574 ) or HealthWatch ( n=575 ) , of whom 581 ( 51 % ) participants completed the study program assessment s at 6 weeks and 504 ( 44 % ) participants completed 6 months ' follow-up . SHUTi significantly lowered depression symptoms on the PHQ-9 at 6 weeks and 6 months compared with HealthWatch ( F[degrees of freedom 2,640·1]=37·2 , p<0·0001 ) . Major depressive disorder was diagnosed in 22 ( 4 % ) participants at 6 months ( n=9 in the SHUTi group and n=13 in the HealthWatch group ) , with no superior effect of SHUTi versus HealthWatch ( Fisher 's exact test=0·52 ; p=0·32 ) . No adverse events were reported . INTERPRETATION Online cognitive behaviour therapy for insomnia treatment is a practical and effective way to reduce depression symptoms and could be capable of reducing depression at the population level by use of a fully automatised system with the potential for wide dissemination . FUNDING Australian National Health and Medical Research Council Forty-five adults with primary insomnia received cognitive-behavioral therapy ( CBT ) implemented in a group therapy format , in individual face-to-face therapy or through brief individual telephone consultations . The results indicate that CBT was effective in improving sleep parameters with all 3 methods of treatment implementation , and there was no significant difference across methods of implementation . All 3 treatment modalities produced improvements in sleep that were maintained for 6 months after treatment completion . These results suggest that group therapy and telephone consultations represent cost-effective alternatives to individual therapy for the management of insomnia OBJECTIVE The aim of this study was to investigate the potential of mindfulness-based stress reduction ( MBSR ) as a treatment for chronic primary insomnia . DESIGN A r and omized controlled trial was conducted . SETTING The study was conducted at a university health center . PATIENTS Thirty adults with primary chronic insomnia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders , Text Revision , 4th Edition were r and omized 2:1 to MBSR or pharmacotherapy ( PCT ) . INTERVENTIONS Mindfulness-based stress reduction , a program of mindfulness meditation training consisting of eight weekly 2.5 hour classes and a daylong retreat , was provided , with ongoing home meditation practice expectations during three-month follow-up ; PCT , consisting of three milligrams of eszopiclone ( LUNESTA ) nightly for eight weeks , followed by three months of use as needed . A 10-minute sleep hygiene presentation was included in both interventions . MAIN OUTCOMES The Insomnia Severity Index ( ISI ) , Pittsburgh Sleep Quality Index ( PSQI ) , sleep diaries , and wrist actigraphy were collected pretreatment , posttreatment ( eight weeks ) , and at five months ( self-reports only ) . RESULTS Between baseline and eight weeks , sleep onset latency ( SOL ) measured by actigraphy decreased 8.9 minutes in the MBSR arm ( P < .05 ) . Large , significant improvements were found on the ISI , PSQI , and diary-measured total sleep time , SOL , and sleep efficiency ( P < .01 , all ) from baseline to five-month follow-up in the MBSR arm . Changes of comparable magnitude were found in the PCT arm . Twenty-seven of 30 patients completed their assigned treatment . This study provides initial evidence for the efficacy of MBSR as a viable treatment for chronic insomnia as measured by sleep diary , actigraphy , well-vali date d sleep scales , and measures of remission and clinical recovery 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 CONTEXT Insomnia is a common condition in older adults and is associated with a number of adverse medical , social , and psychological consequences . Previous research has suggested beneficial outcomes of both psychological and pharmacological treatments , but blinded placebo-controlled trials comparing the effects of these treatments are lacking . OBJECTIVE To examine short- and long-term clinical efficacy of cognitive behavioral therapy ( CBT ) and pharmacological treatment in older adults experiencing chronic primary insomnia . DESIGN , SETTING , AND PARTICIPANTS A r and omized , double-blinded , placebo-controlled trial of 46 adults ( mean age , 60.8 y ; 22 women ) with chronic primary insomnia conducted between January 2004 and December 2005 in a single Norwegian university-based outpatient clinic for adults and elderly patients . INTERVENTION CBT ( sleep hygiene , sleep restriction , stimulus control , cognitive therapy , and relaxation ; n = 18 ) , sleep medication ( 7.5-mg zopiclone each night ; n = 16 ) , or placebo medication ( n = 12 ) . All treatment duration was 6 weeks , and the 2 active treatments were followed up at 6 months . MAIN OUTCOME MEASURES Ambulant clinical polysomnographic data and sleep diaries were used to determine total wake time , total sleep time , sleep efficiency , and slow-wave sleep ( only assessed using polysomnography ) on all 3 assessment points . RESULTS CBT result ed in improved short- and long-term outcomes compared with zopiclone on 3 out of 4 outcome measures . For most outcomes , zopiclone did not differ from placebo . Participants receiving CBT improved their sleep efficiency from 81.4 % at pretreatment to 90.1 % at 6-month follow-up compared with a decrease from 82.3 % to 81.9 % in the zopiclone group . Participants in the CBT group spent much more time in slow-wave sleep ( stages 3 and 4 ) compared with those in other groups , and spent less time awake during the night . Total sleep time was similar in all 3 groups ; at 6 months , patients receiving CBT had better sleep efficiency using polysomnography than those taking zopiclone . CONCLUSION These results suggest that interventions based on CBT are superior to zopiclone treatment both in short- and long-term management of insomnia in older adults . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00295386 Adolescence is a time of change that can be both exciting and stressful . In this review , we focus on the central role that disturbed sleep and daytime sleepiness occupies in interactions involving substance abuse and negative health , social , and emotional outcomes . As a means of improving sleep and lowering risk for recidivism of substance abuse , we developed and implemented a six-session group treatment to treat sleep disturbances in adolescents who have received treatment for substance abuse . The components of the treatment are stimulus control instructions , use of bright light to regularize sleep , sleep hygiene education , cognitive therapy , and Mindfulness-Based Stress Reduction . Preliminary evidence indicates that participants who completed four or more sessions in the treatment program showed improved sleep and that improving sleep may lead to a reduction in substance abuse problems at the 12-month follow-up PURPOSE To determine the feasibility and pilot a sleep education program in New Zeal and high school students . METHODS A parallel , two-arm r and omized controlled pilot trial was conducted . High school students ( 13 to 16 years ) were r and omly allocated to either a classroom-based sleep education program intervention ( n = 15 ) or to a usual curriculum control group ( n = 14 ) . The sleep education program involved four 50-minute classroom-based education sessions with interactive groups . Students completed a 7-day sleep diary , a sleep question naire ( including sleep hygiene , knowledge and problems ) at baseline , post-intervention ( 4 weeks ) and 10 weeks follow-up . RESULTS An overall treatment effect was observed for weekend sleep duration ( F 1,24 = 5.21 , p = 0.03 ) . Participants in the intervention group slept longer during weekend nights at 5 weeks ( 1:37 h : min , p = 0.01 ) and 10 weeks : ( 1:32 h : min , p = 0.03 ) compared to those in the control group . No differences were found between groups for sleep duration on weekday nights . No significant differences were observed between groups for any of the secondary outcomes ( sleep hygiene , sleep problems , or sleep knowledge ) . CONCLUSIONS A sleep education program appears to increase weekend sleep duration in the short term . Although this program was feasible , most schools are under time and re source pressure , thus alternative methods of delivery should be assessed for feasibility and efficacy . Larger trials of longer duration are needed to confirm these findings and determine the sustained effect of sleep education on sleep behavior and its impact on health and psychosocial outcomes . COMMENTARY A commentary on this article appears in this issue on page 793 PURPOSE To estimate prevalence and chronicity of insomnia and the impact of chronic insomnia on health and functioning of adolescents . METHODS Data were collected from 4175 youths 11 - 17 at baseline and 3134 a year later sample d from managed care groups in a large metropolitan area . Insomnia was assessed by youth-reported DSM-IV symptom criteria . Outcomes are three measures of somatic health , three measures of mental health , two measures of substance use , three measures of interpersonal problems , and three of daily activities . RESULTS Over one
Output:
| Gains were generally maintained over time . |
MS213173 | ***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 examine the extent to which district health teams could reduce the burden of malaria , a continuing major cause of mortality and morbidity , in a situation where severe re source constraints existed and integrated care was provided . METHODS Antimalarial drugs were prepackaged into unit doses in an attempt to improve compliance with full courses of chemotherapy . FINDINGS Compliance improved by approximately 20 % in both adults and children . There were 50 % reductions in cost to patients , waiting time at dispensaries and drug wastage at facilities . The intervention , which tended to improve both case and drug management at facilities , was well accepted by health staff and did not involve them in additional working time . CONCLUSION The prepackaging of antimalarials at the district level offers the prospect of improved compliance and a reduction in the spread of resistance We investigated the impact of pre-packaging antimalarial drugs and counselling on compliance with treatment of malaria at the Adult Outpatient Department of Port Moresby General Hospital . Adult patients who were prescribed st and ard antimalarial drugs following clinical and microscopic diagnosis of malaria were r and omly assigned to one of three groups : an intervention group , where pre-packaging and counselling instructions were applied ; control group A , with counselling but no pre-packaging ; and control group B , with neither counselling nor pre-packaging . Patients were interviewed on two occasions , day 1 of treatment and day 4 post treatment . Of a total of 436 patients , 322 patients ( 179 males and 143 females ) completed the study . Our data indicate an increase of 18 % in compliance with treatment in the intervention group and 16 % in control group A , when compared with control group B. While compliance with treatment was gender independent , the language spoken and used for giving instructions and counselling may have influenced patients ' behaviour on prescribed medication . The results of our study indicate that a simple pre-packaging system and proper counselling could improve compliance with antimalarial drug treatment . As an additional beneficial observation , pre-packaging is likely to eliminate errors and possible contamination of the products during dispensing Described are the results of a trial carried out from January to June 1996 in southern Malawi to determine the effectiveness of a treatment pack for infants and children under the age of 6 years , who presented as emergencies to rural health centres with presumptive diagnoses of severe/cerebral malaria or meningitis . Each complete treatment pack ( approximate cost , US$ 6 ) contained , inter alia , intramuscular quinine , intramuscular choloramphenicol , dextrose , paraldehyde , a nasogastric tube , prepacked syringes , and sterile water . A modified coma score and drug dosage nomogram were also included in the package . Despite a considerable drop in overall mortality , problems arose with regard to the incomplete treatment of possible meningitis and in the development of a rational referral policy A study conducted in 1994 showed that the use of blister packs containing antimalarial drugs significantly increased patients ' compliance , compared with traditional means of dispensing drugs in a paper envelope . The present study assessed patients ' compliance and compared the difference between 3-day chloroquine and 8-day primaquine courses of treatment for vivax malaria . The level of real compliance was determined by making the drugs with phenobarbital , and measuring its level in the blood following treatment . The results show that blister packaging significantly improved patients ' compliance ( p < 0.001 ) over traditional means of dispensing antimalarial drugs ; there was no difference in treatment compliance between 3-day and 8-day courses when the drugs were in blister packs . However , with ordinary packaging the treatment compliance rate for an 8-day course was significantly less than for a 3-day course ( P < 0.05 ) This article reports a r and omized controlled trial design ed to test the effects of special packaging of antihypertensive medication on compliance and blood pressure control . One hundred eighty subjects who had exhibited elevated blood pressure greater than 90 mmHg in the two years prior to the study were recruited from patients receiving care at a community hospital-based family medicine practice . After completing preenrollment interviews and blood pressure measurements , subjects were r and omly assigned to receive their antihypertensive medications either in the usual vials or in special unit dose-reminder packaging . Follow-up interviews , pill counts , and blood pressure measurements were performed at three-month intervals . There were no statistically significant differences between the control and experimental groups with regard to age , sex , race , employment , education , marital status , insurance coverage , or blood pressure regimens . Prior to the intervention , the experimental group had slightly lower diastolic blood pressure and reported better compliance than the control group . Analyses performed on 165 subjects completing the first follow-up visit revealed no significant improvements in blood pressure control or compliance for patients receiving special medication packaging . While some patients found it easy to remember to take pills packaged using this format , they also found the packages somewhat more difficult and inconvenient to use . In contrast to previously reported work , this study did not demonstrate any significant improvement in compliance with special packaging of antihypertensive medications OBJECTIVE : The aim of this study was to compare cure rates of Helicobacter pylori ( H. pylori ) infection , compliance , and side effects in patients given 10 days of omeprazole 20 mg b.d . , amoxycillin 500 mg t.d.s . , and metronidazole 400 mg t.d.s . ( OAM ) or 10 days OAM plus compliance enhancing measures . METHODS : A total of 119 H. pylori-positive patients were prospect ively r and omized to receive either 10 days OAM or 10 days OAM plus compliance enhancing measures ( medication in a dose dispensing unit , medication chart , an information sheet about H. pylori treatment , and phone call 2 days after starting therapy ) . H. pylori eradication was assessed by 13C-UBT at least 4 wk after cessation of therapy , compliance by phone interview on the last day of therapy and returned pill count , and side effects by phone interview and returned side effects form . RESULTS : In 113 patients attending 13C-UBT H. pylori was eradicated in 51 of 57 patients ( 89.5 % ) after 10 days OAM and in 48 of 56 ( 85.7 % ) after 10 days OAM plus compliance enhancing measures ( p= 0.54 ) . In both groups 97 % of medications were taken . Side effects were common ( 82 % of patients ) . Both side effects ( p= 0.001 ) and ulcer versus nonulcer at endoscopy ( p= 0.016 ) were independent predictors of treatment failure ; side effects also predicted noncompliance ( p= 0.02 ) . CONCLUSIONS : Ten days of OAM was effective for H. pylori eradication in our clinical population . Patient compliance was excellent and attempts to increase compliance had no impact on outcome or compliance . Side effects were very common and were significantly associated with treatment failure and decreased compliance Three studies were carried out to determine the need , acceptability , and efficacy of adding mefloquine to artemisinin derivatives ( AD ) for the first-line treatment of uncomplicated falciparum malaria . The first was a retrospective study of 255 basic health workers which showed that their recommendation of AD to patients depended on their level of training . None of the paramedics/midwives and only 9 % of 129 doctors had prescribed AD , and no one had recommended AD in combination with mefloquine ; 72 % of patients used courses that were too short for parasitological cure . To promote the addition of mefloquine to AD regimens we conducted intervention workshops with health care providers and subsidized the cost of mefloquine to patients . In the second study , we interviewed 200 patients before and after the intervention to evaluate drug compliance with full doses of AD and use of subsidized mefloquine . After the intervention , we found that only 3.6 % had used mefloquine and 62 % had taken non-curative doses of AD . In the third study , we provided blister packs of medication in daily doses and compared the intake of AD + placebo ( 158 patients ) with that of AD + mefloquine ( 222 patients ) for 5 days . The compliance with both regimens was 99 % . Blood smears for parasites on day 28 showed one positive in the AD + mefloquine group and 7 positive in the AD group . We conclude that provision of blister packs of daily doses is a very effective way to improve compliance with short courses and drug combinations , but the efficacy of the combination in Myanmar in this particular study was only marginally higher than that of AD alone Summary : Fifty‐three hospital out patients with epilepsy were r and omly allocated to either a control or an intervention group . Patients in the intervention group were subjected to a combination of compliance‐improving strategies : patient counselling , a special medication container , self‐recording of medication intake and seizures , and mailed reminders to collect prescription refills and attend clinic appointments . Compliance with anticonvulsant therapy ( as measured by plasma anticonvulsant levels and prescription refill frequencies ) , and seizure frequency , were evaluated in each patient prior to intervention and 6 months afterwards . Patient compliance and clinical control improved significantly in the intervention group patients . Seizure frequency was , on average , halved following intervention . Compliance and seizure frequency were unaltered in the control group . Intervention failed to improve clinic appointment keeping . Poor compliance with drug therapy commonly confounds the treatment of epilepsy . This study shows that compliance can be improved and seizure frequency lessened by strategies that are easily incorporated into the routine management of epileptic patients Malaria is a major cause of morbidity and mortality among children under five in sub-Saharan Africa . Prompt diagnosis and adequate treatment of acute clinical episodes are essential to reduce morbidity and prevent complications and mortality . In many countries , chloroquine syrup is the mainstay of malaria treatment for children under five . Not only is syrup more expensive than tablets , adherence to the prescribed dose at home is a problem because mothers use wrongly sized measuring devices or have difficulty with the instructions . We investigated the impact of introducing pre-packed tablets for children on adherence to treatment and compared the total cost of the tablets with that of syrup . Children aged 0 - -5 years diagnosed with malaria at the clinic over a 6-week period received either pre-packed tablets or syrup by r and om assignment . The principal caregivers were interviewed at home on day 4 after attending the clinic . Of the 155 caregivers given pre-packed tablets , 91 % ( n=141 ) adhered to the recommended dosage , while only 42 % ( n=61 ) of 144 who were provided syrup did . Only 20 % of caregivers who received syrup used an accurate 5 ml measure . The cost of treatment with tablets was about one-quarter that of syrup and 62 % ( n=96 ) of caregivers preferred tablets . Pre-packed chloroquine tablets are a viable alternative to syrup The combination of artesunate and mefloquine is currently one of the most effective treatments against multidrug-resistant Plasmodium falciparum malaria . To improve patient compliance to such a combination , the two agents have been combined in a prepacked single blister . Patients were instructed to simultaneously co-administer the drugs once a day for three days . In the present r and omized , double-blind , parallel group , comparative , single center study in Thail and , this concept was investigated in 204 adults and children with acute , uncomplicated P. falciparum malaria . Patients were r and omized into two treatment groups and received once a day over a three-day period the following : Group A received artesunate , 4 - 5 mg/kg/day , and mefloquine , total dose = 25 mg/kg , approximately 8.5 mg/kg/day , simultaneously . Group B received artesunate , 4 - 5 mg/kg/day , and mefloquine , total dose = 25 mg/kg , sequentially ( i.e. , no mefloquine dose on the first day , 15 mg/kg on the second day , and 10 mg/kg on the third day ) . Both treatment groups showed no relevant differences in baseline demographic and clinical characteristics . Intent-to-treat analysis revealed a cure rate at day 28 ( primary endpoint ) of 100 % in group A and 99 % in group B ( difference not significant ) . The secondary endpoints of mean time to fever clearance ( group A = 34 hours , group B = 31 hours ) and mean time to parasite clearance ( group A = 44 hours group B = 48 hours ) were similar between groups ( both differences not significant ) . Tolerability was good in both treatment groups , with no difference in the overall incidence of adverse events . There was a low incidence of nausea/vomiting ( 4.9 % in both groups ) and central nervous system side effects ( 4.9 % in group A versus 8.8 % in group B ) . These were comparable between groups and generally of a mild nature . The three-day combination of artesunate and mefloquine ( Artequin , Mepha , Ltd. , Aesch , Switzerl and ) with the introduction of mefloquine on day 1 offers a practical dosing regimen that is highly effective and well tolerated in patients of different ages with uncomplicated P. falciparum malaria . It is likely that the prepacked blister approach translates clinical ly into a better patient compliance , thereby contributing to limit the development of drug resistance In rural , malaria-endemic Burkina Faso , we evaluated the impact of the use of pre-packaged antimalarial drugs ( PPAM ) , by mothers in the home , on the progression of
Output:
| There is insufficient evidence to determine the effect of unit-dose packaged antimalarial drugs on treatment failure . |
MS213174 | ***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 : Patients report that the prophylactic consumption of a proton pump inhibitor minimizes gastrointestinal symptoms expected to be provoked by late‐night food and alcohol consumption . The efficacy of this practice has not been studied formally OBJECTIVES : Perception of sensations arising from the gastrointestinal tract may be diminished in obese subjects and thus facilitate overeating . Alternatively , excess food intake may cause gastrointestinal ( GI ) symptoms in obese patients . We evaluated the relationship between body mass index ( BMI ) and specific GI symptoms in the community . METHODS : Residents of Olmsted County , MN were selected at r and om to receive by mail one of two vali date d question naires . The association of reported GI symptoms with BMI ( kg/m2 ) was assessed using a logistic regression analysis adjusting for age , gender , psychosomatic symptom score , and alcohol and tobacco use . RESULTS : Response rate was 74 % ( 1,963 of 2,660 ) . The prevalence of obesity ( BMI ≥ 30 kg/m2 ) was 23 % . There was a positive relationship between BMI and frequent vomiting ( p = 0.02 ) , upper abdominal pain ( p = 0.03 ) , bloating ( p = 0.002 ) , and diarrhea ( p = 0.01 ) . The prevalence of frequent lower abdominal pain , nausea , and constipation was increased among obese ( BMI ≥ 30 kg/m2 ) compared to normal weight participants , however , no significant association was found between BMI and these symptoms . CONCLUSIONS : In the community , increasing BMI is associated with increased upper GI symptoms , bloating , and diarrhea . Clarification of the cause- and -effect relationships and the mechanisms of these associations require further investigation BACKGROUND & AIMS Data on the association between erosive esophagitis and obesity are inconsistent because of variations in study population s and methods used to determine obesity . METHODS Participants in a prospect i ve health-screening cohort underwent esophagogastroduodenoscopy and computed tomography . The association between erosive esophagitis and obesity ( measured by body mass index [ BMI ] , waist circumference , and abdominal visceral adipose tissue volume ) was estimated with odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) , adjusting for confounding factors . We also analyzed the association between obesity and erosive esophagitis by sex . RESULTS The prevalence of erosive esophagitis was 9.3 % ( 495/5329 ) . The OR for erosive esophagitis correlated with obesity measured by BMI , waist circumference , and abdominal visceral adipose tissue volume ( P < .001 for each factor ) . The multivariate OR for erosive esophagitis was 1.97 ( 95 % CI : 1.34 - 2.90 ) for a visceral adipose tissue volume of 500 - 999 cm(3 ) , 2.27 ( 95 % CI : 1.51 - 3.39 ) for 1000 - 1499 cm(3 ) , and 2.94 ( 95 % CI : 1.87 - 4.62 ) for ≥1500 cm(3 ) , compared with participants who had visceral adipose tissue volumes less than 500 cm(3 ) . When measures of obesity were analyzed simultaneously , abdominal visceral adipose tissue volume , but not BMI or waist circumference , was associated with erosive esophagitis . The 3 measures of obesity were significantly associated with erosive esophagitis in males , but only visceral adipose tissue volume was associated with erosive esophagitis in females ( P = .002 ) . CONCLUSIONS In contrast to BMI or waist circumference , abdominal visceral adipose tissue volume is associated with an increased risk of erosive esophagitis in males and females Background —Although fatty foods are commonly considered detrimental in patients with reflux disease , no objective data exist that substantiate this belief . Aims —To investigate the effect of fat on gastro-oesophageal reflux and lower oesophageal sphincter ( LOS ) motor activity . Subjects — Thirteen healthy subjects and 14 patients with reflux disease . Methods —Oesophageal pH , LOS , and oesophageal pressures were recorded for 180 minutes after a high fat ( 52 % fat ) and a balanced ( 24 % fat ) meal ( both 3.18 MJ ) on two different occasions . Eight controls and seven patients were studied in the recumbent position and the others in the sitting position . Results —The percentage of time at pH less than 4 and the rate of reflux episodes were higher ( p<0.01 ) in the patients than in the healthy subjects ( mean 14.1 % versus 1.7 % and 4.4/h versus 0.8/h respectively ) , as was the percentage of transient LOS relaxations associated with reflux ( 62 % versus 32 % , p<0.01 ) . The high fat meal did not increase the rate of reflux episodes nor exposure to oesophageal acid in either group regardless of body posture . The rate of transient LOS relaxations , their association with reflux , and basal LOS pressure were also unaffected . Conclusions —Increasing fat intake does not affect gastro-oesophageal reflux or oesophagogastric competence for at least three hours after a meal Background / Aims : In obesity , many gastro-oesophageal reflux promoting factors are present . Weight reduction is advised to symptomatic overweight subjects . The aim of the present study was to investigate the influences of untreated obesity , weight loss , and chronic gastric balloon distension on the lower oesophageal sphincter ( LOS ) function . Methods : Patients entering a r and omized , double-blind , sham-controlled study of balloon treatment , consisting of 4 months of either sham balloon or balloon treatment followed by 4 months of balloon treatment . Manometry and 24-hour pH measurements were performed at the start of the study and after 13 and 26 weeks . Results : Before treatment , LOS dysfunction was present in 7 of 32 patients ( 21.9 % ) . Increased upright and supine reflux was present in 8 patients ( 25 % ) . Sham treatment result ed in a weight loss of 9.7 % with improved LOS function ( a significant 0.6-cm increase in LOS length and a non-significant 2.6 mm Hg higher LOS pressure ) and in a significantly decreased upright reflux ( acid reflux time decreasing from 8.0 to 5.5 % and number of meal-related and postpr and ial reflux episodes decreasing from 49 to 32 ) . These improved values deteriorated after 4 months of balloon placement , with significantly increasing total , upright , and supine reflux to 7.5 , 7.6 , and 6.7 % of the time , respectively , with oesophageal lesions after an overall 17.8 % weight loss . Four months of balloon treatment induced a similar weight loss ( 9.9 % ) with significantly increased supine reflux from 1.6 to 6.7 % of the time . After a second 4-month balloon period and an overall 13.8 % weight loss , LOS and reflux values returned towards baseline values . A comparison of both groups demonstrated the adverse effects of balloon positioning after a period of substantial sham-induced weight loss . Conclusions : Impaired LOS function and increased gastro-oesophageal reflux were observed in one quarter of the untreated obese subjects . Weight loss ameliorated manometry and pH values , but subsequent balloon positioning tended to counteract these beneficial changes . In patients on balloon treatment from the start , adverse effects seemed to wear off with prolonged treatment Smoking has been shown to be a factor in acid peptic disease . A recent U.S. multicenter trial investigating use of ranitidine in the treatment of gastroesophageal reflux disease provided an opportunity to compare smokers and nonsmokers with regard to demographic features , manifestations of disease , and symptomatic response to treatment . A comparison of characteristics of smokers and nonsmokers revealed similar pretrial clinical findings . No significant differences between groups were found with regard to previous complications or recent symptoms of gastroesophageal reflux disease . There were also no significant differences in the way smokers and nonsmokers responded to treatment . Subjects on ranitidine , regardless of their smoking status , showed significantly greater improvement in heartburn symptoms and consumed less antacid than subjects who received placebo . Results of these analyses indicate that smoking as an independent variable was not related to symptomatic response or esophageal healing and that ranitidine was similarly effective in decreasing heartburn symptoms in smokers and nonsmokers STUDY OBJECTIVE To test the potential of distance running to induce reflux in healthy subjects and the ability of ranitidine to decrease esophageal acid exposure . DESIGN A r and omized , single-blind , crossover study . Objective assessment of reflux was done using an ambulatory intra-esophageal pH monitor during both a baseline hour and 1 hour of running on 2 days of testing . SUBJECTS Fourteen normal volunteers ( 10 men , four women ) between 22 and 37 years of age were studied . All volunteers ran regularly , completing an average of 20 miles weekly for at least 6 months . INTERVENTIONS Ranitidine , 300 mg orally , or an identical placebo was administered after a low-fat breakfast just before the baseline hour of pH recording . SETTING Esophageal motility and pH probe placement was done in the gastroenterology unit at Bowman Gray Medical Center . Running was done on local jogging trials . MEASUREMENTS AND MAIN RESULTS There was more gastroesophageal reflux during running than during the baseline hour when reflux was measured at a pH threshold of 3.0 , 4.0 , or 5.0 ( P less than 0.05 ) . Reflux episodes were usually associated with belching . Ranitidine , 300 mg administered orally 1 hour before running , significantly ( P less than 0.05 ) reduced the amount of esophageal acid exposure during running . CONCLUSIONS Gastroesophageal reflux occurs during running in healthy volunteers . It is usually associated with belching . Acid suppression with ranitidine decreases intraesophageal acid exposure during running ( P less than 0.05 ) OBJECTIVES : Prospect i ve evidence supporting lifestyle modifications , including avoidance of late evening meals , for gastroesophageal reflux disease ( GERD ) sufferers is lacking . The aim of this study was to determine the difference of supine esophageal acid exposure in patients consuming an early or late st and ard meal relative to bedtime . METHODS : This is a prospect i ve , r and omized unblinded crossover trial . Thirty-two patients with typical reflux symptoms were enrolled and r and omized to consume a st and ard meal either at 6 h or 2 h prior to going to bed for 2 consecutive nights . Acid exposure was measured for 48-h using a Bravo wireless pH system . Reflux symptom frequency and severity were recorded . RESULTS : Thirty patients successfully completed the study ( 63 % male , 70 % white , mean age 46 [ 24–74 ] , mean body mass index [ BMI ] 28 kg/m2 [ 18–40 ] ) . EGD revealed esophagitis in 37 % and hiatal hernia ( HH ) in 47 % of patients . Following the late evening meal , there was significantly more supine reflux ( P = 0.002 ) when compared to the early meal . Significantly more supine reflux was also noted following the late evening meal in patients with HH , in overweight individuals ( 25 ≤ BMI ≤ 29.9 ) , and those reporting heartburn as their chief complaint . Patients with esophagitis had more supine reflux following both the late and early evening meals . There was no significant difference in total symptom score between the 2 days . CONCLUSIONS : GERD patients consuming a late-evening meal had significantly greater supine acid reflux compared to when they consumed an early meal , especially in overweight patients , and in patients with esophagitis or HH . These findings support the recommendations to our GERD patients to eat dinner early and to lose weight In order to establish whether alcohol in amounts in amounts customarily imbibed during social drinking causes gastro-oesophageal reflux , 12 healthy young individuals , without symptoms of gastro-oesophageal reflux , were studied twice . Each time , distal oesophageal pH was monitored continuously for three hours after a st and ard meal which included either 180 ml 100 proof vodka or 180 ml water . The order of studies with and without alcohol was r and om . Peak blood alcohol concentrations ranged between 0.63 and 1.29 g/l . Eleven of the 12 subjects refluxed more after alcohol ; and the difference in mean reflux scores for studies with and without alcohol was highly significant . We conclude that relatively modest quanttities of alcohol induce gastro-oesophageal reflux in healthy people This study examines whether eating food at different times has differential effects on intragastric pH. Experiments were done in 23 healthy volunteers ( 1
Output:
| There is recent good evidence that weight reduction and smoking cessation are beneficial in reducing GORD symptoms .
Clinical and physiological studies also suggest that some physical measures as well as modification of meal size and timing can also be beneficial .
However , there is limited evidence for the role of avoiding alcohol and certain dietary ingredients including carbonated drinks , caffeine , fat , spicy foods , chocolate and mint |
MS213175 | ***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 Alzheimer 's disease ( AD ) is estimated to affect up to 11 % of those aged > or = 65 years in the United States , and the number of patients with AD is predicted to increase over the next few decades as the population ages . The substantial social and economic burden associated with AD is well established , with the cost of management increasing as the disease progresses . OBJECTIVE The aim of this study was to evaluate the economic impact of galantamine 16 and 24 mg/d relative to no pharmacologic treatment in the management of mild to moderate AD in the United States based on the concept of need for full-time care ( FTC ) . METHODS Calculations were made using the Assessment of Health Economics in Alzheimer 's Disease model , which applies predictive equations to estimate the need for FTC and the associated costs . The predictive equations were developed from longitudinal data on patients with AD . Inputs to the equations were derived by analyzing the data from 2 r and omized , placebo-controlled , galantamine clinical trials . Re source use ( from a payer perspective ) was estimated from US clinical trial data , and costs were estimated from several US data bases . Analyses were carried out over 10 years , and costs and benefits were discounted at 3 % . RESULTS In the base case , 3.9 to 4.6 patients need to start treatment with galantamine to avoid 1 year of FTC , depending on dose . Treated patients spent 7 % to 8 % more time pre-FTC and 12 % to 14 % less time requiring FTC , result ing in savings of 2408 to 3601 US dollars . Time horizons below 3 years , very high discontinuation rates , or increased survival with galantamine reversed the savings . Conversely , limiting treatment to responders delayed FTC by 6 to 7 months , with savings of approximately 9097 to 11,578 US dollars . CONCLUSIONS These results suggest that use of galantamine in patients with AD in the United States could reduce the use of costly re sources such as formal home care and nursing homes , leading to cost savings over time To investigate whether Galantamine significantly improves the core symptoms of Alzheimer 's disease ( AD ) This 12-week , multinational study compared the tolerability and cognitive effects of donepezil ( up to 10 mg once daily ) and rivastigmine ( up to 6 mg twice daily ) in 111 patients with mild to moderate Alzheimer 's disease . Both medications were administered open label according to recommended dosing regimens from the respective product labelling available during the conduct of the study . More patients in the donepezil group ( 89.3 % ) completed the study compared with the rivastigmine group ( 69.1 % ; p=0.009 ) , and 10.7 % of the donepezil group and 21.8 % of the rivastigmine group discontinued due to adverse events ( AEs ) ; 87.5 % of donepezil-treated patients and 47.3 % of rivastigmine-treated patients remained on the maximum approved dose of each drug at the last study visit . Both groups showed comparable improvements on the ADAS-cog administered by raters blind to study medication at weeks 4 and 12 . Thus , using the recommended dosing schedules , donepezil was better tolerated with fewer discontinuations due to AEs , and both agents improved cognition to a similar extent Objective : To demonstrate the use of cost-effectiveness analysis to assess the economic impact of donepezil in the treatment of mild or moderate AD . Background : Cost-effectiveness analyses show the relationship between re sources used ( costs ) and health benefits achieved ( effects ) for an intervention compared with an alternative strategy . Methods : We developed a model to estimate the incremental cost-effectiveness of donepezil compared with no treatment . We determined costs per quality -adjusted life-years gained , a measurement that enhances the comparability of diverse studies . The model projects the progression of AD patients into more severe disease stages and into nursing homes . Data from a r and omized clinical trial of donepezil were used to assess the drug ’s impact on the 6-week probabilities of progression . Data on the costs and health-related quality of life associated with different disease stages and setting s were taken from published estimates and our companion cross-sectional study , respectively . Results : Donepezil costs are partially offset by a reduction in the costs of care due to enhancement in cognitive functioning and the delay to more costly disease stages and setting s. The magnitude of this cost offset and of the effect of donepezil on health-related quality of life depends on the model ’s assumptions about the duration of the drug effect , where controlled data are lacking . If the drug effect exceeds 2 years , the model predicts that for mild AD the drug would pay for itself in terms of cost offsets . Conclusions : The results of the cost-effectiveness model presented here suggest that donepezil may be cost-effective but additional controlled data on long-term drug efficacy are needed OBJECTIVE To estimate per-patient potential cost savings using rivastigmine in the treatment of Alzheimer 's disease ( AD ) in Canada . BACKGROUND In recent years , new members of a class of pharmaceuticals known as cholinesterase inhibitors have been introduced for the treatment of patients with AD . Two recent studies conducted in the United Kingdom and the United States estimated potential cost savings from the new cholinesterase inhibitor rivastigmine . The present study combined the disease-progression model used in those 2 studies with Canadian costs to estimate per-patient potential savings result ing from the treatment of AD in Canada . METHODS Efficacy data from 2 pivotal , phase III clinical trials of rivastigmine were used in a hazard model of disease progression to estimate long-term differences in cognitive functioning between patients receiving rivastigmine and patients receiving no treatment . We used the Mini-Mental State Examination ( MMSE ) score as our measure of disease progression . We also used Canadian costs of AD care , estimated as a function of MMSE score , to estimate cost savings experienced by treated patients compared with patients receiving no treatment . All costs and cost savings are presented in 1997 Canadian dollars . We used a societal perspective in this analysis . RESULTS Rivastigmine was estimated to delay the transition to more severe stages of AD by up to 188 days for patients with mild AD after 2 years of treatment . For patients with mild-to-moderate and moderate disease , this delay was estimated to be 106 and 44 days , respectively . For patients with the mild stage of AD , estimated average daily cost savings ( excluding the cost of rivastigmine ) ranged from Can $ 0.45 per patient per day at 6 months to Can $ 6.44 per patient per day after 2 years of treatment . For all patients , these estimated average daily cost savings ranged from a low of Can $ 0.71 per patient per day after 6 months of treatment to a high of Can $ 4.93 per patient per day after 2 years . CONCLUSION On average , treatment with rivastigmine yields savings in the direct cost of caring for AD patients that exceed the cost of the drug after 2 years of treatment
Output:
| The key determinants of cost effectiveness were the effectiveness of treatment , the mean treatment cost and the cost savings associated with an expected delay in disease progression .
Conclusions : Results presented in this paper suggest that the use of cholinesterase inhibitors may not be a cost-effective use of NHS re sources .
Guidance from the National Institute for Health and Clinical Effectiveness ( NICE ) in the UK on their judgements surrounding the acceptability of technologies as an effective use of re sources , indicates there would need to be special reasons for accepting cholinesterase inhibitors as a cost-effective use of NHS re sources |
MS213176 | ***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: Unilateral Colles ' fractures in 187 patients over the age of 55 years were studied in a r and omised prospect i ve trial : 97 fractures were minimally displaced and were treated either conventionally or in a crêpe b and age ; 90 displaced Colles ' fractures were reduced and of these 47 were treated conventionally while 43 were encouraged to mobilise the wrist in a cast which restricted extension . Early wrist movement hastened functional recovery and led to earlier resolution of wrist swelling . Discomfort was no greater than in patients who were treated conventionally . The bony deformity , which recurred irrespective of the method of treatment , was not adversely affected by early mobilisation The results of a prospect i ve controlled trial of early mobilisation of Colles ' fractures in the elderly are presented . Early mobilisation produced less pain and a stronger grip . It did not lead to any greater loss of reduction of the fracture . However , there was no significant improvement in the final range of movement of the wrist . Immobilisation of the wrist for six weeks in plaster is extremely inconvenient for the elderly living alone and the patients greatly appreciated the reduction of this period of time to a minimum Twenty-four male New Zeal and rabbits underwent suture repair of a tenotomy of the left achilles tendon . The rabbits were r and omized into two groups of 12 animals ; in group ( A ) , the ankle was immobilized by pinning for 35 days , while in the group ( B ) , the ankle was immobilized for only 14 days followed by active mobilization . Following sacrifice at 35 days postoperatively , the retrieved tendons were evaluated by biomechanical testing and histologic examination . Approximately 50 % of stretching occurred in the first four days ; average overall elongation was 9.5±1.0 mm and 12.7±1.5 mm ( p = 0.102 ) and average stiffness recovery was 67.4±2.0 % and 82.9±1.9 % ( p = 0.0004 ) for groups A and B respectively . Histologically both groups demonstrated traces of disorganized neo-collagen fibers at the repair site as early as the fourth day with subsequent appearance of more mature collagen . The results obtained from our study favor early mobilization of the repaired tendon , which seems to restore the functional properties of the tendons more rapidly than continuous immobilization of an identical surgical repair A question naire was sent out to 59 orthopaedic departments . Seventy-eight percent returned the question naire . Four thous and two hundred ankle fractures are treated annually . Fifty percent are operated on ( range 12.5 - 83 % ) . Large departments are on average more surgically active than smaller ones . The noticeable difference , however , in surgical frequency is not connected to size , function or location of orthopaedic department . All fractures are usually immobilized with a circular plaster b and age . Thirty percent use dynamic b and ages for some stable ankle fractures . Eighty-five percent b and age for six weeks , 15 % for up to eight weeks . Very few allow early mobilization of surgically treated fractures ( 6 % ) . The rest do not allow mobilization until at least three weeks after surgery . Stable fractures are more frequently permitted immediate mobilization . Several r and omized studies recommend that all ankle fractures should be mobilized immediately , surgically treated in a circular plaster b and age , stable fractures in dynamic b and ages In a prospect i ve , r and omized study , 30 patients were evaluated after ankle fracture treated by means of open reduction and internal fixation . The patients were r and omized to either postoperative immobilization in a plaster cast for 6 weeks or early mobilization ( 1–2 weeks after surgery ) in an ankle brace . Both regimens allowed weightbearing . Evaluation after 10 weeks and after 12 months included clinical assessment and isokinetic muscle strength measurements . Patients with impaired ankle function , as shown by means of an ankle score at 12 months , were followed for 3 years . At 10 weeks , impaired muscle torque and restricted range of motion was found on the affected side . This impairment was significantly less in the brace group . At 12 months , range of motion of the ankle and subtalar joints was restored , but dorsiflexion was still better in the brace group . Score values from a functional score did not correlate with muscle strength Two hundred consecutive patients with arthrographically verified rupture of one or both of the lateral ankle ligaments were allocated to treatment with either an operation and a walking cast , walking cast alone , or strapping with an inelastic tape - all for 5 weeks . Eighty-seven percent of the patients attended follow-up after 1 year . Only 5 percent in each treatment group were unsatisfied with the result . There were no differences between the treatment groups in ankle stability or symptoms during different activities , regardless of rupture of the anterior talofibular ligament alone or combined with rupture of the calcaneofibular ligament . However , the patients treated with tape had fewer symptoms , fewer complaints when running , and more ankles recovered to the preinjury state . Therefore , in lateral ankle ligament rupture , tape b and ages seem preferable Ninety consecutive women with unilateral Colles ' fractures were r and omized into two different treatment groups . The control group was treated for 5 weeks in conventional short-arm , below the elbow plaster of Paris casts . The other group ( N = 45 ) was treated similarly in plaster casts for 3 weeks and then had flexible casting applied for the remaining 2 weeks which allowed for early joint mobilization . Functional recovery was assessed by measuring grip strength and joint mobility at intervals over the 3 years . Radiographic and overall assessment s were also made during 3 year course of study . Virtually all patients reported greater comfort after switching to the flexible casting . Mean grip scores and joint mobilities were higher at all time points with early mobilization , reaching levels of statistical significance at 6 months for grip score and at 3 months for joint mobility . By 3 years most differences between treatment groups had resolved . We found no evidence that early mobilization was detrimental to recovery . We conclude that early mobilization is a satisfactory treatment option for Colles ' fracture , and may , in fact , hasten functional recovery Fifty-three patients with dislocated lateral malleolar fractures were r and omly selected after operation for either active ankle movement and weight bearing in an orthosis or no ankle movement but weight bearing in a walking cast . At follow-up examinations after three , six , and 18 months , no differences were found between the groups except for a better linear analogue scale result at three months for the orthosis group . Active ankle movements do not improve the rehabilitation of surgically treated lateral malleolar fractures A prospect i ve r and omised study was performed in order to compare plaster cast with Pliton-80 cast brace with a mobile plastic shoe insert in the treatment of ruptured fibular ankle ligaments . The two treatment groups consisted of 65 patients in each and all were participating in the follow-up sixth months after the accident . There were no statistically significant differences in the overall results between the two treatment groups . Because 1 ) the mobile Pliton-80 b and age subjectively is more acceptable to the patients and -2 ) the disability time in the Pliton-80 group was considerably shorter than in the plaster group -- it was concluded that the mobile Pliton-80 b and age can be recommended as the treatment of ruptures of the fibular ankle ligaments INTRODUCTION Pure posterior dislocation of the elbow is frequent in young subjects . The objective of treatment must be to reduce the dislocation and avoid complications , the most frequent being stiffness , but also elbow instability . The objective of this prospect i ve study was to evaluate the functional and anatomical characteristics of two treatment modalities : plaster immobilization and early mobilization . MATERIAL AND METHODS 50 cases of pure posterior dislocation of the elbow were included in a prospect i ve study and r and omized to two groups : Group I : twenty six cases were treated by reduction under general anaesthesia and plaster immobilization for three weeks , followed by rehabilitation . Group II : twenty four cases were treated by reduction under general anaesthesia , followed by early mobilization . RESULTS We evaluated our results in terms of loss of amplitude of elbow movement ( particularly extension ) , stiffness , instability , relapses , pain and ossification . This study demonstrated better recovery of elbow function in patients treated by early mobilization : 96 % of good results with recovery of normal extension in group II versus 81 % of cases in group I. Stiffness was observed in 19 % of patients in group I versus 4 % in group II ; this difference was very significant . Comparison of pain revealed no significant difference and no relapses , instability or ossifications were observed in either of the two groups . DISCUSSION AND CONCLUSION Early mobilization is superior to plaster immobilization , as it allows recovery of better quality elbow function without inducing instability or recurrence We performed a prospect i ve r and omized study on 60 patients with dorsally displaced extra-articular or noncomminuted intraarticular fractures of the distal radius . All 60 fractures were treated by closed reduction and Kirchner wire trans-styloid fixation . 30 patients had 1 weeks ' postoperative immobilization and 30 patients had 6 weeks ' immobilization . All patients had a clinical and radiographic review at 6 weeks and at 1 year after the operation . Pain , range of movement and grip strength were tested clinical ly , and changes in dorsal tilt , frontal radial deviation , ulnar variance , and radial shortening were assessed radiographically . Rates of complications were the same in both groups . At follow-up , pain was similar in both groups and range of motion and grip strength were somewhat better after early mobilization -- in comparison with the opposite wrist -- but this was statistically significant only for ulnar deviation . The postoperative radiographic reductions were similar in both groups , with no differences in loss of reduction after bone healing . Therefore , in Colles ' fractures , trans-styloid fixation with two K-wires seems to give a stable osteo synthesis , which does not need additional immobilization with a plaster cast A series of 68 undisplaced or minimally displaced Colles ' fractures was r and omized into two groups undergoing treatment with either a plaster cast or an elastic b and age . Pain , function , grip strength , and range of motion were evaluated 1 year later . There was a difference in the functional outcome in favor of the patients treated with an elastic b and age , who did not have more fracture redislocations than those treated with a plaster cast BACKGROUND Different regimens of early motion of the ankle after operative treatment of a ruptured Achilles tendon have been suggested since the late 1980s . However , as far as we know , no controlled studies comparing these regimens with conventional immobilization in a cast have been reported . METHODS In a prospect i ve study , seventy-one patients who had an acute rupture of the Achilles tendon were r and omized to either conventional postoperative management with a cast for eight weeks or early restricted motion of the ankle in a below-the-knee brace for six weeks . The brace was modified with an elastic b and on the posterior surface , in a manner similar to the principle of Kleinert traction . Metal markers were placed in the tendon , and the separation between them was measured on serial radiographs during the first twelve weeks postoperatively . The patients were assessed clinical ly when the cast or brace was removed , at twelve weeks postoperatively , and at a median of sixteen months postoperatively . RESULTS The separation between the markers at twelve weeks postoperatively was nearly identical in the two groups , with a median separation of 11.5 millimeters ( range , zero to thirty-three millimeters ) in the patients managed with early motion of the ankle and nine millimeters ( range , one to forty-one millimeters ) in the patients managed with a cast . The separation was primarily correlated with the initial tautness of the repair ( r[S ] = 0.45 ) . No patient had excessive lengthening of the tendon . The patients managed with early motion had a smaller initial loss in the range of motion , and they returned to work and sports activities sooner than those managed with a cast . Furthermore , there were fewer visible adhesions between the repaired tendon and the skin in the patients managed with early motion , and these patients were subjectively more satisfied with the overall result . The patients in both groups recovered a median of 89 percent of strength of plantar flexion compared with that of the noninjured limb , as measured with an isometric strain-gauge at 15 degrees of dorsiflexion . The heel-rise index was similar for both groups : 0.88 for the patients managed with early motion and 0.89 for those managed with a cast . CONCLUSIONS Early restricted motion appears to shorten the time needed for rehabilitation . There were no complications related to early motion in these patients . However , early unloaded exercises did not prevent muscle atrophy Abstract . The aim of this study was to compare the clinical outcome for patients treated with walking cast immobilization and wrap early mobilization after surgical repair of acute Achilles tendon ruptures . A total of 39 consecutive patients with complete ruptures of the Achilles tendon were identified , treated , and functionally rehabilitated with either a walking cast or a wrap . Because the r and omization was quasi-r and om , chi-square and t-tests were performed to compare the baseline characteristics . A statistically significant difference was present only for the injured side ( p<0.05 ) . Therefore , groups were considered comparable for analysis of outcome . All patients were evaluated at an average follow-up of 6.7 years ( range 5–8 years ) . Functional postoperative treatment with a wrap allowed a significantly shorter hospital stay ( p<0.05 ) as well as a shorter period to return to pre-injury sports level ( p<0.01 ) compared with treatment with a walking cast . According to the modified Rupp score , 91.3 % of patients in the walking cast group had a good or excellent result , as did 93.8 % in the wrap group ( p=0.9 ) . Slight atrophy of the calf muscles was reported in 3 patients in the walking
Output:
| Reported benefits of mobilization included earlier return to work ; decreased pain , swelling , and stiffness ; and a greater preserved range of joint motion .
Early mobilization caused no increased complications , deformity or residual symptoms .
CONCLUSIONS We should not assume any benefit for immobilization after acute upper or lower limb injuries in adults .
Rest appears to be overused as a treatment . |
MS213177 | ***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: Abstract Aims To describe self-care of T2DM patients and to evaluate outcomes associated with self-care in T2DM patients . Methods A multicentre cross-sectional study was conducted on a sample of 302 r and omly selected T2DM patients . Clinical and socio-demographic data were collected by medical records . The Summary of Diabetes Self-care Activities was used to measure self-care about diet , blood testing , exercise and foot care . The EQ-5D was used to measure perceived quality of life . Multiple regression models were used to evaluate the associations between self-care and body mass index ( BMI ) , glycated haemoglobin ( HbA1c ) , presence of diabetes complications and quality of life ( QoL ) . Results Self-care was lower about exercise ( median = 2.0 ) and foot care ( median = 3.5 ) than about diet ( median = 5.2 ) and blood testing ( median = 4.5 ) . HbA1c was associated with diet ( p = 0.025 ) , exercise ( p = 0.017 ) and blood testing ( p = 0.034 ) . BMI was associated with exercise ( p = 0.0071 ) . Diabetes complications were associated with exercise ( p = 0.031 ) and blood testing ( p < 0.009 ) . QoL was associated with exercise ( p < 0.0001 ) , blood testing ( p = 0.032 ) and foot care ( p = 0.013 ) . Conclusions Self-care influences both clinical outcomes and quality of life of T2DM patients . Although exercise is more frequently associated with positive outcomes , it is particularly poor in T2DM population . Blood testing and foot care should be performed to prevent complications and not only when a health problem is already occurred . Interventions aim ed to improve exercise are recommended . Further research is needed to explore barriers to exercise AIM This study describes the development and validation of the Nursing Profession Self-Efficacy Scale . BACKGROUND Self-efficacy can be useful in predicting performance , job satisfaction or well-being . In the nursing field , there is a shortage of studies on self-efficacy with regard to nurses ' global confidence in coping ability across a range of everyday , challenging work situations . METHODS To define the theoretical framework of nursing professional self-efficacy , two focus groups and a literature review were performed . An empirical study was then conducted to test validity and reliability . Face and content validity , construct validity , concurrent validity , internal consistency and test-retest reliability were examined . The content validity index was evaluated by 12 experts who suggested deleting 11 redundant items . The final developed tool was tested for construct analysis using a cross-validation approach , r and omly splitting the overall sample of 917 nurses in two sub-groups . FINDINGS The construct validity indicated two dimensions . The face and content validity were adequate . Test-retest reliability displayed a good stability , and internal consistency ( Cronbach 's α ) was acceptable . Moreover , concurrent validity using the Generalized Self-Efficacy Scale was in line with the theoretical framework . CONCLUSION The scale showed evidence of validity and reliability . The major limitation is the strong influence of the Italian context in the tool development . IMPLICATION S FOR NURSING AND HEALTH POLICY The Nursing Profession Self-Efficacy Scale could be a fruitful tool that facilitates the application of theories ( i.e. social-cognitive theory ) in the nursing field and even development of interventions . Furthermore , a measurement of self-efficacy could be used to predict nursing clinical performance BACKGROUND Burnout ( BO ) is increasingly considered a public health problem : it is not only harmful to the individual , but also for the organization . Therefore , in recent years , research has given particular attention to the study of the phenomenon and its antecedents among the nursing profession . In the last ten years , the literature shows the prevalence of BO in different clinical setting s , but there are few recent data describing the phenomenon and its relationship with educational preventive programs . OBJECTIVES The aims of this study are : a ) to describe the prevalence of nurses ' risk of BO in the northern Italy area b ) to describe nurses ' coping and their perception of the BO antecedents . c ) to describe the effects of education on the nurses ' coping and their recognition of BO antecedents . METHODS The study is structured into two main parts . The first was cross-sectional , the second was prospect i ve . Burnout Potential Inventory ( BPI ) question naire was used in the cross-sectional part to survey risk of BO in three big hospitals in Northern Italy . The Health Profession Stress and Coping Scale ( HPSCS ) was used in the prospect i ve part to survey the nurses ' stress perception and their coping mechanisms in a post-graduate educational program . RESULTS Nurses ' BO risk is within the normal range , although the BPI highlighted three borderline subscales : poor team work , work overload and poor feedback . Post-graduate education had a positive effect on the stress perception , but it is not sufficient to improve coping mechanisms . CONCLUSIONS The study revealed the more stressful work situations and the effect of post-graduate education to prevent the effects of stress . This topic needs further investigation in the light of the result of this study CONTEXT Low literacy is an important barrier for patients with diabetes , but interventions to address low literacy have not been well examined . OBJECTIVE To examine the role of literacy on the effectiveness of a comprehensive disease management program for patients with diabetes . DESIGN , SETTING , AND PARTICIPANTS Analysis of the influence of literacy on glycemic control and systolic blood pressure using data from a r and omized controlled trial ( conducted from February 2001 through April 2003 ) of a comprehensive diabetes management program . Participants were 217 patients aged 18 years or older with type 2 diabetes and poor glycemic control ( glycosylated hemoglobin [ HbA1c ] levels > or = 8.0 % ) and presenting to a US academic general internal medicine practice . INTERVENTIONS All communication to patients was individualized and delivered to enhance comprehension among patients with low literacy . Intervention patients received intensive disease management from a multidisciplinary team . Control patients received an initial management session and continued with usual care . MAIN OUTCOME MEASURES Achievement of goal HbA1c levels and systolic blood pressure at 12-month follow-up for control and intervention patients stratified by literacy status . RESULTS Complete 12-month data were available for 193 patients ( 89 % ) . Among patients with low literacy , intervention patients were more likely than control patients to achieve goal HbA1c levels ( < or = 7.0 % ) ( 42 % vs 15 % , respectively ; adjusted odds ratio [ OR ] , 4.6 ; 95 % confidence interval [ CI ] , 1.3 to 17.2 ; P = .02 ) . Patients with higher literacy had similar odds of achieving goal HbA1c levels regardless of intervention status ( 24 % vs 23 % ; adjusted OR , 1.0 ; 95 % CI , 0.4 to 2.5 ; P = .98 ) . Improvements in systolic blood pressure were similar by literacy status . CONCLUSIONS Literacy may be an important factor for predicting who will benefit from an intervention for diabetes management . A diabetes disease management program that addresses literacy may be particularly beneficial for patients with low literacy , and increasing access to such a program could help reduce health disparities BACKGROUND Although limited health literacy is common in hemodialysis patients , its effects on clinical outcomes are not well understood . STUDY DESIGN Observational study . SETTING & PARTICIPANTS 260 maintenance hemodialysis patients enrolled in a r and omized clinical trial of symptom management strategies from January 2009 through April 2011 . PREDICTOR Limited health literacy . OUTCOMES Dialysis adherence ( missed and abbreviated treatments ) and health re source utilization ( emergency department visits and end-stage renal disease [ESRD]-related hospitalizations ) . MEASUREMENTS We assessed health literacy using the Rapid Estimate of Adult Literacy in Medicine ( REALM ) and used negative binomial regression to analyze the independent associations of limited health literacy with dialysis adherence and health re source utilization over 12 - 24 months . RESULTS 41 of 260 ( 16 % ) patients showed limited health literacy ( REALM score , ≤60 ) . There were 1,152 missed treatments , 5,127 abbreviated treatments , 552 emergency department visits , and 463 ESRD-related hospitalizations . Limited health literacy was associated independently with an increased incidence of missed dialysis treatments ( missed , 0.6 % vs 0.3 % ; adjusted incidence rate ratio [ IRR ] , 2.14 ; 95 % CI , 1.10 - 4.17 ) , emergency department visits ( annual visits , 1.7 vs 1.0 ; adjusted IRR , 1.37 ; 95 % CI , 1.01 - 1.86 ) , and hospitalizations related to ESRD ( annual hospitalizations , 0.9 vs 0.5 ; adjusted IRR , 1.55 ; 95 % CI , 1.03 - 2.34 ) . LIMITATIONS Generalizability and potential for residual confounding . CONCLUSIONS Patients receiving maintenance hemodialysis who have limited health literacy are more likely to miss dialysis treatments , use emergency care , and be hospitalized related to their kidney disease . These findings have important clinical practice and cost implication OBJECTIVES To examine the relationships among patient characteristics , labor inputs , and improvement in glycosylated hemoglobin ( A1C ) level in a successful primary care-based diabetes disease management program ( DDMP ) . STUDY DESIGN We performed subanalyses to examine the relationships among patient characteristics , labor inputs , and improvement in A1C level within a r and omized controlled trial . Control patients received usual care , while intervention patients received usual care plus a comprehensive DDMP . METHODS The primary outcome was improvement in A1C level over 12 months stratified by intervention status and patient characteristics . Process outcomes included the number of actions or contacts with patients , time spent with patients , and number of glucose medication titrations or additions . RESULTS One hundred ninety-three of 217 enrolled patients ( 88.9 % ) had complete 12-month followup data . Patients in the intervention group had significantly greater improvement in A1C level than the control group ( -2.1 % vs -1.2 % , P = .007 ) . In multivariate analysis , no significant differences were observed in improvement in A1C level when stratified by age , race/ethnicity , income , or insurance status , and no interaction effect was observed between any covariate and intervention status . Among intervention patients , we observed similar labor inputs regardless of age , race/ethnicity , sex , education , or whether goal A1C level was achieved . CONCLUSIONS Among intervention patients in a successful DDMP , improvement in A1C level was achieved regardless of age , race/ethnicity , sex , income , education , or insurance status . Labor inputs were similar regardless of age , race/ethnicity , sex , or education and may reflect the nondiscriminatory nature of providing algorithm-based disease management care
Output:
| Areas of consensus are HL definition , HL measurement tools , and the relationship between T2DM patient knowledge ( or literacy ) and his/her HL .
The gaps in knowledge were the assessment of the relations between HL and health outcomes and self-efficacy , the gender differences , the effectiveness of interventions to improve HL , the cost-effectiveness study of interventions to improve HL , and the underst and ing of the influence of organizational environment on HL . |
MS213178 | ***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 Elucidating the neurobiological effects of sleep and waking remains an important goal of the neurosciences . Recently , animal studies indicated that sleep is important for cell membrane and myelin maintenance in the brain and that these structures are particularly susceptible to insufficient sleep . Here , we tested the hypothesis that a day of waking and sleep deprivation would be associated with changes in diffusion tensor imaging ( DTI ) indices of white matter microstructure sensitive to axonal membrane and myelin alterations . Methods Twenty-one healthy adult males underwent DTI in the morning [ 7:30AM ; time point (TP)1 ] , after 14 hours of waking ( TP2 ) , and then after another 9 hours of waking ( TP3 ) . Whole brain voxel-wise analysis was performed with tract based spatial statistics . Results A day of waking was associated with widespread increases in white matter fractional anisotropy , which were mainly driven by radial diffusivity reductions , and sleep deprivation was associated with widespread fractional anisotropy decreases , which were mainly explained by reductions in axial diffusivity . In addition , larger decreases in axial diffusivity after sleep deprivation were associated with greater sleepiness . All DTI changes remained significant after adjusting for hydration measures . Conclusions This is the first DTI study of sleep deprivation in humans . Although previous studies have observed localized changes in DTI indices of cerebral microstructure over the course of a few hours , further studies are needed to confirm widespread DTI changes within hours of waking and to clarify whether such changes in white matter microstructure serve as neurobiological substrates of sleepiness Diffusion-weighted MRI ( DW-MRI ) has become a popular imaging modality for probing the microstructural properties of white matter and comparing them between population s in vivo . However , the contrast in DW-MRI arises from the microscopic r and om motion of water molecules in brain tissues , which makes it particularly sensitive to macroscopic head motion . Although this has been known since the introduction of DW-MRI , most studies that use this modality for group comparisons do not report measures of head motion for each group and rely on registration -based correction methods that can not eliminate the full effects of head motion on the DW-MRI contrast . In this work we use data from children with autism and typically developing children to investigate the effects of head motion on differences in anisotropy and diffusivity measures between groups . We show that group differences in head motion can induce group differences in DW-MRI measures , and that this is the case even when comparing groups that include control subjects only , where no anisotropy or diffusivity differences are expected . We also show that such effects can be more prominent in some white-matter pathways than others , and that they can be ameliorated by including motion as a nuisance regressor in the analyses . Our results demonstrate the importance of taking head motion into account in any population study where one group might exhibit more head motion than the other Few studies have used diffusion tensor imaging ( DTI ) to investigate the micro-structural alterations of WM in patients with restrictive eating disorders ( rED ) , and longitudinal data are lacking . Twelve patients with rED were scanned at diagnosis and after one year of family-based treatment , and compared to twenty-four healthy controls ( HCs ) through DTI analysis . A tract-based spatial statistics procedure was used to investigate diffusivity parameters : fractional anisotropy ( FA ) and mean , radial and axial diffusivities ( MD , RD and AD , respectively ) . Reduced FA and increased RD were found in patients at baseline in the corpus callosum , corona radiata and posterior thalamic radiation compared with controls . However , no differences were found between follow-up patients and controls , suggesting a partial normalization of the diffusivity parameters . In patients , trends for a negative correlation were found between the baseline FA of the right anterior corona radiata and the Eating Disorder Examination Question naire total score , while a positive trend was found between the baseline FA in the splenium of corpus callosum and the weight loss occurred between maximal documented weight and time of admission . A positive trend for correlation was also found between baseline FA in the right anterior corona radiata and the decrease in the Obsessive-Compulsive Inventory Revised total score over time . Our results suggest that the integrity of the limbic – thalamo – cortical projections and the reward-related circuitry are important for cognitive control processes and reward responsiveness in regulating eating behavior BACKGROUND Anorexia nervosa is characterized by extreme low body weight and alterations in affective processing . The subcallosal cingulate regulates affect through wide-spread white matter connections and is implicated in the pathophysiology of anorexia nervosa . OBJECTIVES We examined whether those with treatment refractory anorexia nervosa undergoing deep brain stimulation ( DBS ) of the subcallosal white matter ( SCC ) show : ( 1 ) altered anatomical SCC connectivity compared to healthy controls , ( 2 ) white matter microstructural changes , and ( 3 ) microstructural changes associated with clinical ly-measured affect . METHODS Diffusion magnetic resonance imaging ( dMRI ) and deterministic multi-tensor tractography were used to compare anatomical connectivity and microstructure in SCC-associated white matter tracts . Eight women with treatment-refractory anorexia nervosa were compared to 8 age- and sex-matched healthy controls . Anorexia nervosa patients also completed affect-related clinical assessment s presurgically and 12 months post-surgery . RESULTS ( 1 ) Higher ( e.g. , left parieto-occipital cortices ) and lower ( e.g. , thalamus ) connectivity in those with anorexia nervosa compared to controls . ( 2 ) Decreases in fractional anisotropy , and alterations in axial and radial diffusivities , in the left fornix crus , anterior limb of the internal capsule ( ALIC ) , right anterior cingulum and left inferior fronto-occipital fasciculus . ( 3 ) Correlations between dMRI metrics and clinical assessment s , such as low pre-surgical left fornix and right ALIC fractional anisotropy being related to post-DBS improvements in quality -of-life and depressive symptoms , respectively . CONCLUSIONS We identified widely-distributed differences in SCC connectivity in anorexia nervosa patients consistent with heterogenous clinical disruptions , although these results should be considered with caution given the low number of subjects . Future studies should further explore the use of affect-related connectivity and behavioral assessment s to assist with DBS target selection and treatment outcome The objective was to examine whether cerebral volumes are reduced , and in what regions , in adolescents with anorexia nervosa and to study changes after nutritional recovery . Twelve anorexia nervosa ( DSM-IV ) patients aged 11 - 17 consecutively admitted to an Eating Disorders Unit were assessed by means of psychopathological scales , neuropsychological battery and voxel-based morphometric ( VBM ) magnetic resonance imaging at admission and after 7 months ' follow-up . Nine control subjects of similar age , gender and estimated intelligence level were also studied . The two groups showed differences in gray matter ( F=22.2 ; p<0.001 ) and cerebrospinal fluid ( CSF ) ( F=21.2 ; p<0.001 ) but not in white matter volumes . In anorexic patients , gray matter volume correlated negatively with the copy time from the Rey Complex Figure Test . In the regional VBM study several temporal and parietal gray matter regions were reduced . During follow-up there was a greater global increase in gray matter ( F=10.7 ; p=0.004 ) and decrease in CSF ( F=22.1 ; p=0.001 ) in anorexic patients . The increase in gray matter correlated with a decrease in cortisol ( Spearman correlation=-0.73 ; p=0.017 ) . At follow-up there were no differences in global gray matter ( F=2.1 ; p=0.165 ) , white matter ( F=0.02 , p=0.965 ) or CSF ( F=1.8 ; p=0.113 ) volumes between both groups . There were still some smaller areas , in the right temporal and both supplementary motor area , showing differences between them in the regional VBM study . In conclusion , in adolescent anorexic patients gray matter is more affected than white matter and mainly involves the posterior regions of the brain . Overall gray matter alterations are reversible after nutritional recovery
Output:
| It was less clear whether white matter alterations persist after recovery from anorexia nervosa .
Conclusion White matter microstructure appears to be affected in anorexia nervosa , and these alterations may play a role in the pathophysiology of this eating disorder .
Although we found white matter alterations in bulimia nervosa that were similar to those in anorexia nervosa , white matter changes in bulimia nervosa remain poorly investigated , and these findings were less conclusive . |
MS213179 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Summary Background Many human milk benefits have been well documented ; nevertheless the newborn potential risk to the xenobiotic exposition may be relevant and it requires a biological monitoring in general prevention . Concerning this problem , attention should be paid to mycotoxins and heavy metals . Aim of the study Assessing the presence of the xenobiotics aflatoxins , ochratoxin A , lead and cadmium in human milk , defining their level of contamination and evaluate the potential risk for the newborn derived from this xenobiotic ingestion . Methods A study has been carried out on lactating women r and omly selected in seven hospitals in Lombardy ( Northern Italy ) . Two hundred and forty – seven puerparae were recruited ; 231 women participated in the study . Women ’s milk sample s on the third or fourth day after delivery were tested to determine aflatoxins and ochratoxin A levels . Lead and cadmium were determined in 143 women because supplemental milk could be taken only from these women . Results Aflatoxin B1 ( 11.4 ng/l ) and aflatoxin M1 ( 194 ng/l ) were found only in one sample , while ochratoxin A was detected in 198 sample s ( 85.7 % ) at an average value of 6.01 ± 8.31 ng/l . A total of 75.7 % of sample s were positive for lead ; the cadmium situation was better with 87.4 % of the sample with values below detection limits ( 2 µg/l ) . A high percentage of babies ( 71 % ) are exposed to mycotoxin levels on day 6 greater than the TDI value of 0.2 ng/kg b.w . Lead and cadmium presence in human milk presented risk respectively for 8 % and 0.7 % of newborns on the fourth day ; 9.5 % and 1.4 % on the sixth day . Conclusions The study points out that mycotoxins and lead are present in maternal milk , and the data confirm the need to continue biological monitoring in general prevention
Output:
| Conclusions : Breast milk is a pathway of maternal excretion of cadmium .
It is also a biological indicator of the degree of environmental pollution and cadmium exposure of the lactating woman and the nourished infant . |
MS213180 | ***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 Postoperative delirium and cognitive decline are common in elderly surgical patients after non-cardiac surgery . Despite this prevalence and clinical importance , no specific aetiological factor has been identified for postoperative delirium and cognitive decline . In experimental setting in a rat model , nitrous oxide ( N(2)O ) produces neurotoxic effect at high concentrations and in an age-dependent manner . Whether this neurotoxic response may be observed clinical ly has not been previously determined . We hypothesized that in the elderly patients undergoing non-cardiac surgery , exposure to N(2)O result ed in an increased incidence of postoperative delirium than would be expected for patients not receiving N(2)O. METHODS Patients who were > or=65 yr of age , undergoing non-cardiac surgery and requiring general anaesthesia were r and omized to receive an inhalational agent and either N(2)O with oxygen or oxygen alone . A structured interview was conducted before operation and for the first two postoperative days to determine the presence of delirium using the Confusion Assessment Method . RESULTS A total of 228 patients were studied with a mean ( range ) age of 73.9 ( 65 - 95 ) yr . After operation , 43.8 % of patients developed delirium . By multivariate logistic regression , age [ odds ratio ( OR ) 1.07 ; 95 % confidence interval ( CI ) 1.02 - 1.26 ] , dependence on performing one or more independent activities of daily living ( OR 1.54 ; 95 % CI 1.01 - 2.35 ) , use of patient-controlled analgesia for postoperative pain control ( OR 3.75 ; 95 % CI 1.27 - 11.01 ) and postoperative use of benzodiazepine ( OR 2.29 ; 95 % CI 1.21 - 4.36 ) were independently associated with an increased risk for postoperative delirium . In contrast , the use of N(2)O had no association with postoperative delirium . CONCLUSIONS Exposure to N(2)O result ed in an equal incidence of postoperative delirium when compared with no exposure to OBJECTIVES To determine whether donepezil hydrochloride can reduce the prevalence and severity of delirium in older adults undergoing hip fracture repair . DESIGN Pilot double-masked r and omized placebo-controlled trial . SETTING Large academic medical center . PARTICIPANTS Sixteen individuals aged 70 and older with hip fracture . INTERVENTION Donepezil 5 mg or placebo was r and omly allocated and initiated within 24 hours of surgery , preoperatively or postoperatively . Daily treatment was continued for 30 days or until side effects or the clinical situation required termination . MEASUREMENTS All outcomes were ascertained masked to treatment status . Information on drug tolerability and safety was obtained from the participant , nurse , and medical record . Delirium presence and severity were measured during daily hospital interviews and at 2 , 4 , and 6 weeks after surgery after a st and ardized assessment using the Confusion Assessment Method ( CAM ) and the Memorial Delirium Assessment Scale ( MDAS ) . RESULTS Participants in the donepezil and placebo arms had similar baseline characteristics . Participants in the donepezil arm experienced significantly more side effects . In longitudinal models , there were no significant differences between the donepezil and placebo arms with regard to delirium presence over time ( odds ratio = 0.9 , 95 % confidence interval ( CI ) = 0.4 - 2.3 ) or delirium severity over time ( effect size = -0.2 on 30-point MDAS scale , 95%CI = -1.5 - 1.2 ) . CONCLUSION Participants r and omized to donepezil had no significant improvement in delirium presence or severity but experienced more side effects . Overall , sufficient evidence was not found from this pilot study to warrant a definitive Phase III trial Background and objectives : Postoperative confusion and delirium is a common complication in the elderly with a poorly understood pathophysiology . The aim of this study was to examine whether the type of anaesthesia ( general or regional ) plays a role in the development of cognitive impairment in elderly patients during the immediate postoperative period . Methods : Forty‐seven patients > 60 yr of age and undergoing major surgery were r and omly allocated to receive either regional or general anaesthesia . The mental status of the patients was assessed preoperatively and during the first three postoperative days with the Mini Mental State Examination . The incidence of delirium was also examined during the same period with the use of DSM III criteria . Results : Overall , during the first three postoperative days , the mean Mini Mental State Examination score decreased significantly ( P < 0.001 ) . However , this decline was very significant only in patients assigned to receive general anaesthesia ( P < 0.001 ) compared to regional anaesthesia . Nine patients developed delirium but the type of anaesthesia did not affect its incidence . The only important factor for the development of delirium was pre‐existing cardiovascular disease irrespective of anaesthesia type ( P < 0.025 ) . Conclusions : Elderly patients subjected to general anaesthesia displayed more frequent cognitive impairment during the immediate postoperative period in comparison to those who received a regional technique OBJECTIVE To determine whether limiting intraoperative sedation depth during spinal anesthesia for hip fracture repair in elderly patients can decrease the prevalence of postoperative delirium . PATIENTS AND METHODS We performed a double-blind , r and omized controlled trial at an academic medical center of elderly patients ( > or=65 years ) without preoperative delirium or severe dementia who underwent hip fracture repair under spinal anesthesia with propofol sedation . Sedation depth was titrated using processed electroencephalography with the bispectral index ( BIS ) , and patients were r and omized to receive either deep ( BIS , approximately 50 ) or light ( BIS , > or=80 ) sedation . Postoperative delirium was assessed as defined by Diagnostic and Statistical Manual of Mental Disorders ( Third Edition Revised ) criteria using the Confusion Assessment Method beginning at any time from the second day after surgery . RESULTS From April 2 , 2005 , through October 30 , 2008 , a total of 114 patients were r and omized . The prevalence of postoperative delirium was significantly lower in the light sedation group ( 11/57 [ 19 % ] vs 23/57 [ 40 % ] in the deep sedation group ; P=.02 ) , indicating that 1 incident of delirium will be prevented for every 4.7 patients treated with light sedation . The mean + /- SD number of days of delirium during hospitalization was lower in the light sedation group than in the deep sedation group ( 0.5+/-1.5 days vs 1.4+/-4.0 days ; P=.01 ) . CONCLUSION The use of light propofol sedation decreased the prevalence of postoperative delirium by 50 % compared with deep sedation . Limiting depth of sedation during spinal anesthesia is a simple , safe , and cost-effective intervention for preventing postoperative delirium in elderly patients that could be widely and readily adopted Background Recent studies have indicated that unmanaged pain , both acute and chronic , can affect mental status and might precipitate delirium , especially in elderly patients with hip fractures . The aim of this study was to assess the effectiveness of fascia iliaca compartment block ( FICB ) for prevention of perioperative delirium in hip surgery patients who were at intermediate or high risk for this complication . Material s and methods On admission , all included patients were divided into three groups according to low , intermediate or high risk for perioperative delirium . Eligible patients ( those classified as at intermediate or high risk for developing delirium ) were sequentially r and omly assigned to study treatment ( FICB prophylaxis or placebo ) according to a computer-generated r and omization code . The primary outcome was perioperative delirium . Diagnosis of the syndrome was defined using the Diagnostic and Statistical Manual of Mental Disorders , 4th edition ( DSM-IV ) and Confusion Assessment Method ( CAM ) criteria . Secondary outcome variables were severity of delirium and delirium duration . Results Delirium occurred in 33 ( 15.94 % ) out of 207 patients r and omized to FICB prophylaxis or the placebo group . Incidence of delirium in the FICB prophylaxis group was 10.78 % ( 11/102 ) , significantly different from the incidence ( 23.8 % , 25/105 ) in the placebo group [ relative risk 0.45 , 95 % confidence interval ( CI ) 0.23–0.87 ] . Nine of 17 patients with high risk for delirium and included in the FICB prophylaxis group developed delirium , whereas 10 of 16 high-risk patients included in the placebo group became delirious ( relative risk 0.84 , CI 0.47–1.52 ) . Two of 85 patients with intermediate risk for delirium and included in the FICB prophylaxis group developed delirium , whereas 15 of 89 intermediate-risk patients included in the placebo group became delirious ( relative risk 0.13 , CI 0.03–0.53 ) . Severity of delirium according to the highest value of the DRSR-98 during an episode with delirium in patients in the FICB prophylaxis group was on average 14.34 , versus 18.61 in the placebo group ( mean difference 4.27 , 95 % CI 1.8–5.64 , P < 0.001 ) . Mean duration of delirium in the FICB prophylaxis group was significantly shorter than in the placebo group ( FICB 5.22 days versus placebo 10.97 days , 95 % CI 3.87–7.62 , P < 0.001 ) . Conclusion No significant difference was found among high-risk patients between FICB prophylaxis and placebo groups in terms of delirium incidence . However , FICB prophylaxis significantly prevented delirium occurrence in intermediate-risk patients . Thus FICB prophylaxis could be beneficial , particularly for intermediate-risk patients Background : Intravenous and inhalation anesthesia are commonly used in the clinical setting . Recovery of cognitive function in elderly patients after surgery has received increased attention . In this study , the authors compared recovery of cognitive function in patients after different anesthesia techniques , and investigated which technique is safer . The authors also explored association between apolipoprotein E4 and postoperative cognitive dysfunction in patients undergoing general anesthesia . Methods : A total of 2,000 patients were equally and r and omly divided into intravenous and inhalation anesthesia groups . Total intravenous and inhalation anesthesia were used . Within 10 days after surgery , cognitive function was assessed daily using the Mini-Mental State Examination ( MMSE ) . Restriction fragment length polymorphism of apolipoprotein E gene was analyzed . The primary outcome was MMSE score , frequency distribution of apolipoprotein E alleles and genotypes . P < 0.01 was used as statistically significant . Results : MMSE score in inhalation preoperative baseline group significantly decreased at day 3 after surgery compared with the preoperational and intravenous anesthesia group . The proportion of patients scoring less than 25 points was significantly greater in the inhalation anesthesia group than in the intravenous anesthesia group at 3 days after surgery . In the inhalation anesthesia group , the decrease in MMSE score was closely related with apolipoprotein E & egr;4 allele . In the intravenous anesthesia group , the decrease in MMSE score was not correlated with apolipoprotein E & egr;4 allele . Conclusions : There was a strong association between the apolipoprotein E & egr;4 and postoperative cognitive dysfunction in elderly patients undergoing inhalation anesthetics BACKGROUND Delirium is a serious postoperative condition for which few pharmacologic prevention trials have been conducted . OBJECTIVE The authors tested the efficacy of perioperative olanzapine administration to prevent postoperative delirium in elderly patients after joint-replacement surgery . METHOD The authors conducted a r and omized , double-blind , placebo-controlled , prophylaxis trial at an orthopedic teaching hospital , enrolling 495 elderly patients age ≥65 years , who were undergoing elective knee- or hip-replacement surgery ; 400 patients received either 5 mg of orally-disintegrating olanzapine or placebo just before and after surgery . The primary efficacy outcome was the incidence of ( DSM-III-R ) delirium . RESULTS The incidence of delirium was significantly lower in the olanzapine group than in the placebo group ; this held true for both knee- and hip-replacement surgery . However , delirium lasted longer and was more severe in the olanzapine group . Advanced age , a high level of medical comorbidity , an abnormal albumin level , and having knee-replacement surgery were independent risk factors for postoperative delirium ( Clinical trials.gov Identifier : NCT000699946 ) . CONCLUSION Administration of 10 mg of oral olanzapine perioperatively , versus placebo , was associated with a significantly lower incidence of delirium . These findings suggest that olanzapine prophylaxis of postoperative delirium may be an effective strategy HYPOTHESIS
Output:
| This meta- analysis has shown that peri-operative geriatric consultations with multicomponent interventions and lighter anaesthesia are potentially effective in decreasing the incidence of postoperative delirium |
MS213181 | ***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 Single-modality radiotherapy is still considered st and ard treatment for patients with locally advanced unresectable cancer of the head and neck . As treatment outcome is poor , attempts to integrate chemotherapy into the overall management of these patients are ongoing . PATIENTS AND METHODS A r and omized study was undertaken to compare a sequential with a simultaneous chemoradiotherapy program . Between February 1986 and February 1991 , 93 eligible patients with locally advanced unresectable cancer of the head and neck were stratified by WHO PS , T and N class and primary site and then r and omized to receive either three courses of neoadjuvant chemotherapy with cisplatin ( 100 mg/m2 i.v . d 1 ) and 5-fluorouracil 1000 mg/m2/days 1 - 5 by continuous i.v . infusion every 3 weeks prior to definitive conventional radiotherapy of 65 - 70 Gy ( sequential treatment ) , or cisplatin 100 mg/m2 on days 1 , 22 , 43 given simultaneously for the duration of the same conventional radiotherapy ( simultaneous treatment ) . RESULTS At the end of the entire treatment 18 complete responses ( 47 % ) in the sequential-treatment arm and 18 ( 41 % ) in the simultaneous treatment arm were obtained . No statistically significant differences in the 5-yr progression-free survival , in the median time to loco-regional and distant progression and in the 5-yr overall survival were observed . Leukopenia was more frequent in the simultaneous than in the sequential arm ( p = 0.03 ) , whereas alopecia ( p = 0.008 ) and phlebitis ( p < 0.0001 ) were more frequent in the sequential-treatment arm . A better compliance was associated with the concomitant treatment , with 87 % of the patients completing the entire radiotherapy program versus 63 % of those in the sequential arm ( p = 0.01 ) . CONCLUSIONS In the present study , the two treatment arms showed similar activity ( complete response , progression-free and overall survival rates ) . Compliance to treatment was better in the concomitant arm . These data suggest that concomitant chemo-radiation therapy might be considered an option in unresectable locally advanced cancer of the head and neck . Phase III studies are needed in order to establish the superiority of this combination of cisplatin and radiotherapy versus radiotherapy alone BACKGROUND AND PURPOSE This phase II study evaluated the efficacy and toxicity of weekly cisplatin along with concomitant boost accelerated radiation regimen in patients with locally advanced unresectable head and neck carcinoma . MATERIAL AND METHODS A total of 94 patients ( median age , 58 years ) with UICC stage III ( n = 19 ) and IV ( n = 75 ) cancer of the oropharynx , larynx , hypopharynx and oral cavity were included . Patients received radiotherapy with a concomitant boost scheme ( 1.8 Gy on days 1 - 40 and 1.5 Gy boost on days 25 - 40 with a total dose of 72 Gy ) and concurrent cisplatin , 40 mg/m(2 ) weekly , for the first 4 weeks . RESULTS Most patients ( 95 % ) received both radiation and chemotherapy according to protocol . Toxicity was manageable with grade III mucositis and pharyngeal-oesophageal toxicity in 85 and 50 % of patients , respectively . Haematological toxicity was mild . Four patients ( 4 % ) died due to complications . With a median follow of 41 months , median overall survival and time to progression were 27 and 25 months , respectively . The estimated overall survival at 4 years was 41 % . CONCLUSIONS Concomitant boost accelerated radiation plus concurrent weekly cisplatin is a feasible schedule in patients with locally advanced unresectable head and neck carcinoma , with acceptable toxicity and survival data BACKGROUND Our goal was to evaluate long-term efficacy outcomes of patients with squamous cell carcinoma of the head and neck ( SCCHN ) treated with carboplatin , paclitaxel ( Taxol ) and radiotherapy . PATIENTS AND METHODS We conducted a phase II trial in inoperable patients with locally advanced SCCHN . Carboplatin 100 mg/m(2 ) and paclitaxel 40 mg/m(2 ) were administered i.v . once a week during external beam radiation therapy ( 180 cGy per fraction ) for 6 - 7 weeks . Interstitial brachytherapy was used as a boost in selected patients with primary malignancies of the oral cavity and the oropharynx . RESULTS Fifty-five patients were enrolled . Fifty-two patients ( 95 % ) had stage IV and 51 ( 93 % ) had technically unresectable disease ; 62 % had an oropharyngeal primary site . Twenty-one patients underwent brachytherapy boost . Grade 3 or 4 mucositis occurred in 30 % of patients . One death occurred during treatment that was related to complications of gastrostomy tube placement . Forty of 50 assessable patients ( 80 % ) had an objective response , with a complete response rate of 52 % . With a median follow-up of 69 months for surviving patients , the 5-year progression-free survival was 36 % and the 5-year overall survival was 35 % . Two of the 18 long-term survivors of > 50 months were gastrostomy tube feeding dependent . Patients undergoing brachytherapy boost ( n = 21 ) had similar outcomes compared with the rest of the patients . In multivariate analysis , baseline hemoglobin levels and N stage were predictive of survival . CONCLUSION Treatment with concurrent carboplatin , paclitaxel and radiation is safe and offers curative potential for poor prognosis patients with locally advanced SCCHN We compared concurrent chemoradiotherapy ( CCRT ) with docetaxel , cisplatin ( CDDP ) , and 5-fluorouracil ( 5-FU ) ( TPF ) with CCRT with CDDP , 5-FU , methotrexate and leucovorin ( PFML ) in patients with locally advanced squamous cell carcinoma of the head and neck ( SCCHN ) in terms of safety and efficacy on survival . A total of 100 patients were enrolled . The TPF group received CCRT with the TPF regimen [ docetaxel ( 50 mg/m2 : day 1 ) , CDDP ( 60 mg/m2 : day 4 ) , and continuous 5-FU infusion ( 600 mg/m2/day : days 1–5 ) ] . In the PFML group , patients received CCRT with the PFML regimen [ CDDP ( 60 mg/m2 : day 4 ) ] , continuous 5-FU infusion ( 600 mg/m2/day : days 1–5 ) , methotrexate ( 30 mg/m2 : day 1 ) and leucovorin ( 20 mg/m2/day : days 1–5 ) ] . Both groups received 2 cycles of chemotherapy during definitive radiotherapy . The total radiation dose was between 66.6 and 70.2 Gray . The overall response rates after CCRT were 98 with 90 % of a pathologically complete response ( pCR ) in the TPF group and 94 with 77 % in the PFML group . For grade 3/4 adverse events , mucositis was more frequent in the PMFL group , and the TPF group showed a higher incidence of hematological toxicity . CCRT with TPF or PMFL for advanced SCCHN was tolerable and produced excellent survival rates PURPOSE To select one of two chemoradiotherapy regimens for locally advanced squamous cell carcinoma ( SCC ) of the head and neck as the experimental arm for the next Trans-Tasman Radiation Oncology Group phase III trial . PATIENTS AND METHODS One hundred twenty-two previously untreated patients with stage III/IV SCC of the head and neck were r and omized to receive definitive radiotherapy ( 70 Gy in 7 weeks ) concurrently with either cisplatin ( 75 mg/m(2 ) ) plus tirapazamine ( 290 mg/m(2)/d ) on day 2 of weeks 1 , 4 , and 7 , and tirapazamine alone ( 160 mg/m(2)/d ) on days 1 , 3 , and 5 of weeks 2 and 3 ( TPZ/CIS ) , or cisplatin ( 50 mg/m(2 ) ) on day 1 and infusional fluorouracil ( 360 mg/m(2)/d ) on days 1 through 5 of weeks 6 and 7 ( chemoboost ) . RESULTS Three-year failure-free survival rates were 55 % with TPZ/CIS ( 95 % CI , 39 % to 70 % ) and 44 % with chemoboost ( 95 % CI , 30 % to 60 % ; log-rank P = .16 ) . Three-year locoregional failure-free rates were 84 % in the TPZ/CIS arm ( 95 % CI , 71 % to 92 % ) and 66 % in the chemoboost arm ( 95 % CI , 51 % to 79 % ; P = .069 ) . More febrile neutropenia and grade 3 or 4 late mucous membrane toxicity were observed with TPZ/CIS , while acute skin radiation reaction was more severe and prolonged with chemoboost . Compliance with protocol treatment was satisfactory on both arms . CONCLUSION Both regimens are feasible and are associated with significant but acceptable toxicity profiles in the cooperative group setting . Based on the promising efficacy seen in this trial , TPZ/CIS is being evaluated in a large phase III trial BACKGROUND A r and omized phase 3 trial of the treatment of squamous-cell carcinoma of the head and neck compared induction chemotherapy with docetaxel plus cisplatin and fluorouracil ( TPF ) with cisplatin and fluorouracil ( PF ) , followed by chemoradiotherapy . METHODS We r and omly assigned 501 patients ( all of whom had stage III or IV disease with no distant metastases and tumors considered to be unresectable or were c and i date s for organ preservation ) to receive either TPF or PF induction chemotherapy , followed by chemoradiotherapy with weekly carboplatin therapy and radiotherapy for 5 days per week . The primary end point was overall survival . RESULTS With a minimum of 2 years of follow-up ( > or =3 years for 69 % of patients ) , significantly more patients survived in the TPF group than in the PF group ( hazard ratio for death , 0.70 ; P=0.006 ) . Estimates of overall survival at 3 years were 62 % in the TPF group and 48 % in the PF group ; the median overall survival was 71 months and 30 months , respectively ( P=0.006 ) . There was better locoregional control in the TPF group than in the PF group ( P=0.04 ) , but the incidence of distant metastases in the two groups did not differ significantly ( P=0.14 ) . Rates of neutropenia and febrile neutropenia were higher in the TPF group ; chemotherapy was more frequently delayed because of hematologic adverse events in the PF group . CONCLUSIONS Patients with squamous-cell carcinoma of the head and neck who received docetaxel plus cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy had a significantly longer survival than did patients who received cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy . ( Clinical Trials.gov number , NCT00273546 [ Clinical Trials.gov ] . ) A r and omized phase 2 study was performed to investigate the efficacy/toxicity of combining concomitant boost radiation and weekly carboplatin/paclitaxel with or without amifostine in patients with locally advanced squamous cell carcinoma of the head and neck ( SCCHN ) BACKGROUND A phase II study was conducted using concurrent paclitaxel , carboplatin , and external beam radiotherapy ( RT ) in patients with advanced head and neck cancer . METHODS Forty-three patients ( stage III , n = 12 ; stage IV , n = 31 ) were treated with 8 cycles of weekly paclitaxel ( 60 mg/m(2 ) ) , carboplatin ( area under the curve [ AUC ] = 1 ) , and RT ( 1.8 Gy daily ; total dose , 66 - 72 Gy ) . Patients with initially palpable lymph nodes underwent neck dissection . RESULTS The overall clinical response rate was 91 % ( 65 % complete , 26 % partial ) . Severe mucositis occurred in 37 ( 90 % ) patients , necessitating hospitalization in 13 ( 31 % ) patients . With a median follow-up of 49 months , the locoregional and distant failure rates were 26 % and 21 % , respectively . CONCLUSIONS Concurrent paclitaxel , carboplatin , and RT for advanced head and neck cancer results in high complete response rates . Long-term follow-up has revealed the curative potential of this regimen , though the doses used result ed in unacceptable toxicity BACKGROUND . Simultaneous radiochemotherapy result ed in a significant benefit improving both local control and overall survival in advanced head and neck cancer . In this phase II study the efficacy and tox
Output:
| The improved overall survival observed supports the choice of taxane-based regimens in the concurrent setting but may also reflect the predominance of single arm multi-agent phase II trials in the taxane arm . |
MS213182 | ***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: Abstract Purpose Exercise training as an add-on to medical therapy has been shown to improve exercise capacity , quality of life , and possibly prognosis in patients with pulmonary hypertension ( PH ) . The purpose of this study was to analyze the impact of exercise training on healthcare costs in PH . Methods Estimated healthcare costs have been compared between patients with severe PH under optimized medical therapy only ( control group ) versus patients who received exercise training as an add-on to medical therapy ( training group ) . Cost- analysis included a cost-estimation model of costs for baseline and follow-up visits and all PH-related healthcare events that occurred within the follow-up period . Time to clinical worsening and survival were assessed by clinical records , phone , and /or control visits . Results At baseline , the training ( n = 58 ) and control group ( n = 48 ) did not differ in age , gender , WHO-functional class , 6-min walking distance , hemodynamic parameters , or PH-targeted medication . During a follow-up of 24 ± 12 months , the training group had significantly better survival rates at 1 and 3 years and less worsening events ( death , lung transplantation , hospitalization due to PH , new PAH-targeted medication ) than the control group ( 15 vs. 25 events , p < 0.05 ) , which also led to lower estimated healthcare costs of 657 € within a period of 2 years . Conclusions This is the first study to investigate the cost-effectiveness of exercise training in PH . Due to less worsening events within 2 years , healthcare costs were lower in patients performing exercise training as add-on to medical therapy than in patients with medical treatment only . Further prospect i ve , r and omized studies are needed to confirm these findings Abstract Objectives To evaluate whether careful exercise training improves pulmonary perfusion and blood flow in patients with pulmonary hypertension ( PH ) , as assessed by magnetic resonance imaging ( MR ) . Methods Twenty patients with pulmonary arterial hypertension or inoperable chronic thromboembolic PH on stable medication were r and omly assigned to control ( n = 10 ) or training groups ( n = 10 ) . Training group patients received in-hospital exercise training ; patients of the sedentary control group received conventional rehabilitation . Medication remained unchanged during the study period . Changes of 6-min walking distance ( 6MWD ) , MR pulmonary flow ( peak velocity ) and MR perfusion ( pulmonary blood volume ) were assessed from baseline to week 3 . Results After 3 weeks of training , increases in mean 6MWD ( P = 0.004 ) and mean MR flow peak velocity ( P = 0.012 ) were significantly greater in the training group . Training group patients had significantly improved 6MWD ( P = 0.008 ) , MR flow ( peak velocity −9.7 ± 8.6 cm/s , P = 0.007 ) and MR perfusion ( pulmonary blood volume + 2.2 ± 2.7 mL/100 mL , P = 0.017 ) , whereas the control group showed no significant changes . Conclusion The study indicates that respiratory and physical exercise may improve pulmonary perfusion in patients with PH . Measurement of MR parameters of pulmonary perfusion might be an interesting new method to assess therapy effects in PH . The results of this initial study should be confirmed in a larger study group . Key Points• Quantification of magnetic resonance perfusion is feasible in patients with pulmonary hypertension . • Quantified magnetic resonance perfusion may become useful for non-invasive monitoring of treatment . • Quantification of lung perfusion allows new insights into lung (patho-)physiology of PH . • Careful exercise training improves pulmonary perfusion and blood flow in patients with PH Background — Pulmonary hypertension ( PH ) is associated with restricted physical capacity , limited quality of life , and a poor prognosis because of right heart failure . The present study is the first prospect i ve r and omized study to evaluate the effects of exercise and respiratory training in patients with severe symptomatic PH . Methods and Results — Thirty patients with PH ( 21 women ; mean age , 50±13 years ; mean pulmonary artery pressure , 50±15 mm Hg ; mean World Health Organization [ WHO ] class , 2.9±0.5 ; pulmonary arterial hypertension , n=23 ; chronic thromboembolic PH , n=7 ) on stable disease-targeted medication were r and omly assigned to a control ( n=15 ) and a primary training ( n=15 ) group . Medication remained unchanged during the study period . Primary end points were the changes from baseline to week 15 in the distance walked in 6 minutes and in scores of the Short Form Health Survey quality -of-life question naire . Changes in WHO functional class , Borg scale , and parameters of echocardiography and gas exchange also were assessed . At week 15 , patients in the primary and secondary training groups had an improved 6-minute walking distance ; the mean difference between the control and the primary training group was 111 m ( 95 % confidence interval , 65 to 139 m ; P<0.001 ) . Exercise training was well tolerated and improved scores of quality of life , WHO functional class , peak oxygen consumption , oxygen consumption at the anaerobic threshold , and achieved workload . Systolic pulmonary artery pressure values at rest did not change significantly after 15 weeks of exercise and respiratory training ( from 61±18 to 54±18 mm Hg ) within the training group . Conclusions — This study indicates that respiratory and physical training could be a promising adjunct to medical treatment in severe PH . The effects add to the beneficial results of modern medical treatment Background — Factors that determine survival in pulmonary arterial hypertension ( PAH ) drive clinical management . A quantitative survival prediction tool has not been established for research or clinical use . Methods and Results — Data from 2716 patients with PAH enrolled consecutively in the US Registry to Evaluate Early and Long-Term PAH Disease Management ( REVEAL ) were analyzed to assess predictors of 1-year survival . We identified independent prognosticators of survival and derived a multivariable , weighted risk formula for clinical use . One-year survival from the date of enrollment was 91.0 % ( 95 % confidence interval [ CI ] , 89.9 to 92.1 ) . In a multivariable analysis with Cox proportional hazards , variables independently associated with increased mortality included pulmonary vascular resistance > 32 Wood units ( hazard ratio [ HR ] , 4.1 ; 95 % CI , 2.0 to 8.3 ) , PAH associated with portal hypertension ( HR , 3.6 ; 95 % CI , 2.4 to 5.4 ) , modified New York Heart Association/World Health Organization functional class IV ( HR , 3.1 ; 95 % CI , 2.2 to 4.4 ) , men > 60 years of age ( HR , 2.2 ; 95 % CI , 1.6 to 3.0 ) , and family history of PAH ( HR , 2.2 ; 95 % CI , 1.2 to 4.0 ) . Renal insufficiency , PAH associated with connective tissue disease , functional class III , mean right atrial pressure , resting systolic blood pressure and heart rate , 6-minute walk distance , brain natriuretic peptide , percent predicted carbon monoxide diffusing capacity , and pericardial effusion on echocardiogram all predicted mortality . Based on these multivariable analyses , a prognostic equation was derived and vali date d by bootstrapping technique . Conclusions — We identified key predictors of survival based on the patient 's most recent evaluation and formulated a contemporary prognostic equation . Use of this tool may allow the individualization and optimization of therapeutic strategies . Serial follow-up and re assessment are warranted . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00370214 OBJECTIVE To characterize mortality in persons diagnosed with primary pulmonary hypertension and to investigate factors associated with survival . DESIGN Registry with prospect i ve follow-up . SETTING Thirty-two clinical centers in the United States participating in the Patient Registry for the Characterization of Primary Pulmonary Hypertension supported by the National Heart , Lung , and Blood Institute . PATIENTS Patients ( 194 ) diagnosed at clinical centers between 1 July 1981 and 31 December 1985 and followed through 8 August 1988 . MEASUREMENTS At diagnosis , measurements of hemodynamic variables , pulmonary function , and gas exchange variables were taken in addition to information on demographic variables , medical history , and life-style . Patients were followed for survival at 6-month intervals . MAIN RESULTS The estimated median survival of these patients was 2.8 years ( 95 % Cl , 1.9 to 3.7 years ) . Estimated single-year survival rates were as follows : at 1 year , 68 % ( Cl , 61 % to 75 % ) ; at 3 years , 48 % ( Cl , 41 % to 55 % ) ; and at 5 years , 34 % ( Cl , 24 % to 44 % ) . Variables associated with poor survival included a New York Heart Association ( NYHA ) functional class of III or IV , presence of Raynaud phenomenon , elevated mean right atrial pressure , elevated mean pulmonary artery pressure , decreased cardiac index , and decreased diffusing capacity for carbon monoxide ( DLCO ) . Drug therapy at entry or discharge was not associated with survival duration . CONCLUSIONS Mortality was most closely associated with right ventricular hemodynamic function and can be characterized by means of an equation using three variables : mean pulmonary artery pressure , mean right atrial pressure , and cardiac index . Such an equation , once vali date d prospect ively , could be used as an adjunct in planning treatment strategies and allocating medical re sources Background Advances in the underst and ing and management of pulmonary arterial hypertension have enabled earlier diagnosis and improved prognosis . However , despite best available therapy , symptoms of exertional dyspnoea and fatigue are commonly reported and result in a reduced capacity to perform daily activities and impaired quality of life . Exercise training has demonstrated efficacy in individuals with other respiratory and cardiovascular diseases . Historically , however , exercise training has not been utilised as a form of therapy in pulmonary arterial hypertension due to the perceived risk of sudden cardiac death and the theoretical possibility that exercise would lead to worsening pulmonary vascular haemodynamics and deterioration in right heart function . Now , with the advances in pharmaceutical management , determining the safety and benefits of exercise training in this population has become more relevant . Only three studies of supervised exercise training in pulmonary arterial hypertension have been published . These studies demonstrated improvements in exercise capacity and quality of life , in the absence of adverse events or clinical deterioration . However , these studies have not utilised an outpatient-based , whole body exercise training program , the most common format for exercise programs within Australia . It is uncertain whether this form of training is beneficial and capable of producing sustained benefits in exercise capacity and quality of life in this population . Design / Methods This r and omised controlled trial will determine whether a 12 week , outpatient-based , supervised , whole body exercise training program , followed by a home-based exercise program , is safe and improves exercise capacity and quality of life in individuals with pulmonary arterial hypertension . This study aims to recruit 34 subjects who will be r and omly allocated to the exercise group ( supervised exercise training 3 times a week for 12 weeks , followed by 3 sessions per week of home exercise for 12 weeks ) or the control group ( usual medical care ) . Subjects will be assessed at baseline , 12 weeks and 24 weeks . Discussion This study will determine whether outpatient-based , whole body exercise training is beneficial and safe in individuals with pulmonary arterial hypertension . Additionally , this study will contribute to clinical practice guidelines for this patient population .Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) : The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . Background Aim of this prospect i ve study was to evaluate the effects of exercise training in patients with inoperable or residual chronic thromboembolic pulmonary hypertension ( CTEPH ) . Methods Thirty-five consecutive patients with invasively confirmed inoperable or residual CTEPH ( 16 women;19 men ; mean age 61±15 years , mean pulmonary artery pressure , 63±20 mmHg ; primary inoperable n = 33 , persisting pulmonary hypertension after pulmonary endarterectomy n = 2 ) on stable disease-targeted medication received exercise training in-hospital for 3 weeks and continued at home for 15 weeks . Medication remained unchanged during the study period . Efficacy parameters have been evaluated at baseline , after 3 and 15 weeks by blinded-observers . Survival rate has been evaluated in a follow-up period of median 36.4 months ( interquartile range 26.6–46.6 months ) . Results All patients tolerated exercise training without severe adverse events . Patients significantly improved the mean distance walked in 6 minutes compared to baseline by 61±54 meters after 3 weeks ( p<0.001 ) and by 71±70 meters after 15 weeks ( p = 0.001 ) , as well as scores of quality -of-life question naire , peak oxygen consumption and maximal workload . NT-proBNP improved significantly after 3 weeks of exercise training ( p = 0.046 ) . The 1-year survival rate was 97 % , 2
Output:
| In people with PH , exercise-based rehabilitation results in clinical ly relevant improvements in exercise capacity .
Exercise training was not associated with any serious adverse events .
Whilst most studies reported improvements in HRQoL , these may not be clinical ly important . |
MS213183 | ***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: Summary A prospect i ve r and omized double-blind trial comparing the butyrophenone analogue domperidone ( D ) and the synthetic cannabinoid nabilone ( N ) in the treatment of cytotoxic-induced emesis was conducted in 38 patients receiving highly emetogenic chemotherapy regimens ( 70 % containing cisplatin ) . Patients received 20 mg D or 1 mg N the night before chemotherapy and 8-hourly on each chemotherapy day for two consecutive cycles of treatment . Three of 19 patients r and omized to N completed only one cycle because of disease progression ( 2 ) or subjectively adverse effects ( 1 ) . Four of 19 patients completed only one cycle of D because of lack of efficacy ( 3 ) or chemotherapy toxicity ( 1 ) . In all , 32 cycles of N and 33 cycles of D were evaluable for efficacy . The mean number of vomiting episodes in cycle 1 was 4.76 for N and 12.95 for D ( P<0.02 ) . The corresponding values for cycle 2 were 4.27 and 7.69 ( P>0.10 ) , and for cycles 1 and 2 combined , 4.53 for N and 10.81 for D ( P<0.01 ) . Nausea and food intake scores did not differ significantly , although there was a trend towards less nausea and an increased food intake with N. Subjectively adverse effects were more frequent with N and included drowsiness , dizziness , dry mouth , and postural hypotension . N is superior to D for the control of cytotoxic-induced emesis In a prospect i ve , double-blind study , we have examined the effect of preoperative nabilone on postoperative nausea and vomiting ( PONV ) . Sixty women , less than 70 yr old , undergoing total abdominal hysterectomy , were allocated r and omly to receive either nabilone 2 mg or metoclopramide 10 mg orally 90 min before induction of anaesthesia . The study was design ed to detect a 50 % difference in the incidence of postoperative vomiting between the two groups , with an 80 % power of achieving a statistically significant result at the 5 % level . Data from 53 patients were analysed : the incidences of nausea and vomiting for the metoclopramide group were 70 % and 67 % , respectively ; the corresponding values for the nabilone group were 73 % and 54 % . These differences were not significant A prospect i ve r and omised double blind crossover trial was conducted comparing the new synthetic cannabinoid nabilone with oral domperidone in a group of children receiving repeated identical courses of emetogenic chemotherapy for a variety of malignant diseases . Eighteen of 23 consecutive eligible children , aged 10 months to 17 years , completed the trial . When taking nabilone they experienced significantly fewer vomiting episodes and less nausea , and two thirds expressed a preference for the drug . The most common side effects of treatment with nabilone were somnolence and dizziness , with one patient being disturbed by hallucinations . The results indicate that nabilone is an effective antiemetic for children having chemotherapy , even for young children . It seems to be superior in this respect to domperidone , and although it has a higher incidence of side effects , these are mostly acceptable to patients . It can be recommended as an alternative to conventional antiemetic treatment throughout childhood The antinausea and antivomiting effects of delta-9-tetrahydrocannabinol ( THC ) in children receiving cancer chemotherapy were compared with those of metoclopramide syrup and prochlorperazine tablets in two double-blind studies . THC was found to be a significantly better antinausea and antivomiting agent , but not all patients obtained relief of nausea and vomiting with THC . In some patients , THC enhanced appetite during a course of chemotherapy . In two patients , a " high " associated with THC administrationwas reported . Drowsiness was reported significantly more frequently with THC Nabilone , a synthetic cannabinoid , and Prochlorperazine were compared in a double-blind crossover study of 34 patients with lung cancer undergoing a 3-day schedule of chemotherapy with Cyclophosphamide , Adriamycin and Etoposide . Symptom scores were significantly better for patients on nabilone for nausea , retching and vomiting ( P less than 0.05 ) . Fewer subjects vomited with nabilone ( P = 0.05 ) and the number of vomiting episodes was lower ( P less than 0.05 ) ; no patients on nabilone required additional parenteral anti-emetic . More patients preferred nabilone for anti-emetic control ( P less than 0.005 ) . Adverse effects common with nabilone were drowsiness ( 57 % ) , postural dizziness ( 35 % ) and lightheadedness ( 18 % ) . Euphoria was seen in 14 % and a " high " in 7 % . Erect systolic blood pressure was lower in nabilone patients on Day 1 ( P = 0.05 ) but postural hypotension was a major problem in only 7 % . Nabilone is an effective oral anti-emetic drug for moderately toxic chemotherapy , but the range and unpredictability of its side-effects warrant caution in its use In March 1979 , the Governor of the State of Washington signed legislation establishing a THC/marihuana research program within the Washington State Board of Pharmacy . By November 1980 , approximately 80 physicians had enrolled more than 400 patients on the chemotherapy protocol which r and omly assigned subjects to receive either THC and prochlorperazine or THC and placebo . This report describes the process of implementing the legislation , the administrative and clinical roles of project personnel , and the design of three currently operating protocol FACTORS INFLUENCING PREFERENCE FOR THC vs. COMPAZINE ( prochlorperazine ) as an antiemetic agent during cancer chemotherapy were studied in 139 patients who received both medications in a double-blind r and omized crossover design trial . Nausea reduction was the main determinant of preference . THC preference was associated with more , rather than fewer , drug-related side effects than Compa-zine , particularly sedation . Patients who reported being anxious or depressed did not experience accentuation of their mood states with either regime . Mood effects , nausea reduction , incidence of side effects , and drug preference were the same in patients under and over 50 years of age . Patients with a history of illicit drug use reported fewer side effects from THC , but reported no difference in drug preference or nausea reduction compared to those patients without a history of illicit use The antiemetic effect of oral nabilone , a synthetic cannabinoid , given at a dose of 2 mg every 12 hours was compared to oral slow-release capsules of prochlorperazine given at a dose of 10 mg every 12 hours by a double-blind crossover method in 37 patients receiving cancer chemotherapy . Patients received one of the following as the primary emetic stimulus : high-dose cis-dichlorodiammineplatinum(II ) ( DDP ) , low-dose DDP , mechlorethamine , streptozotocin , actinomycin D , or DTIC . Although results varied according to strength of emetic stimulus received , both nabilone and prochlorperazine appeared to produce antiemetic effects . Eighteen of the 37 patients achieved a complete or partial elimination of symptoms : seven with nabilone alone , three with prochlorperazine alone , and eight with each drug . Nabilone appeared to be the more effective antiemetic for patients who received chemotherapy agents other than high dose DDP ; it was equivalent to prochlorperazine for those who did receive high-dose DDP . Side effects from prochlorperazine were limited to mild drowsiness occurring among 35 % of the patients . The side effects from nabilone were drowsiness and dizziness which occurred frequently and were dose-limiting in 25 % of patients Thirty-two patients were entered into a double blind trial of antiemetic support in patients being treated with cisplatin . Patients were allocated to receive either oral nabilone ( 1 mg 8 hourly ) or intravenous metoclopramide ( 1 mg kg−1 3 hourly ) in r and om order over 4 courses . There was no difference between the two treatments in the overall incidence or severity of vomiting , although a subgroup of patients enjoyed a substantial reduction in episodes of vomiting whilst receiving metoclopramide . Side-effects were predictable from the pharmacology of the drugs Summary Twenty nonseminomatous testicular cancer patients not pretreated with emetogenic chemotherapy were included in a crossover study of antiemetic therapy . Patients were r and omly assigned to receive either nabilone ( 2 × 2 mg/day ) or alizapride ( 3 × 150 mg/day ) prior to beginning lowdose cisplatin chemotherapy . Patients on nabilone had significantly fewer episodes of emesis than those on alizapride ( medians , 1.1 vs 2.9;p<0.01 ) . Nabilone was superior to alizapride in giving complete relief from nausea ( medians , 65 % vs 30%;p<0.01 ) , and was more effective in shortening the duration of nausea ( medians , 1.3 h vs 5.1 h;p<0.01 ) ; however , it caused more adverse effects . It is concluded that nabilone has greater antiemetic activity than alizapride in young patients receiving low-dose cisplatin chemotherapy . Nabilone dosage should be reduced to decrease the incidence and degree of adverse reactions while leaving the definite antiemetic activity unchanged Delta‐9‐tetrahydrocannabinol ( THC ) and prochlorperazine ( Compazine ) were found to be equally efficacious in reducing nausea and vomiting associated with cancer chemotherapy across a wide range of chemotherapeutic regimens and tumor types . Both drugs were administered orally one hour before chemotherapy , then every four hours for a total of four doses . Compazine was administered in a fixed dose of 10 mg ; THC was administered by body surface area ( BSA ) : BSA < 1.4 m2 = 7.5 mg ; BSA 1.4‐1.8 m2 = 10 mg ; and BSA > 1.8 m2 = 12.5 mg . Two hundred and fourteen subjects ( 75 % of whom had previously received Compazine with varying results ) were evaluated employing a double‐blind , crossover design . Additional parameters evaluated were study drug effects on appetite , food intake , mood , activity , relaxation , interaction , and concentration . There were significant drug effects with THC : less ability to concentrate ( P < 0.01 ) , less social interaction ( P < 0.05 ) , and less activity ( P < 0.05 ) . There were no significant differences between the two drugs in the level of food intake or appetite . Patients of all ages did equally well on both drugs . Neither past marijuana use nor past Compazine use were related to study drug efficacy . Those patients who correctly identified their THC cycle did better on THC versus those who could not correctly identify which antiemetic they had received ( P < 0.05 ) . There were more drug‐related effects associated with THC , but these did not reduce the patients ' preference for the drug , and were associated with nausea reduction ( P < 0.05 ) AN ANTI-EMETIC DRUG , NABILONE , a synthetic cannabinoid , has been compared with prochlorperazine in 24 lung cancer patients receiving cancer chemotherapy . Each of the drugs studied was given orally every 12 hours , starting the night before chemotherapy , during one of two consecutive identical chemotherapy cycles in accordance with a double-blind crossover r and om order assignment . Single doses were 2 mg of nabilone , or 15 mg of prochlorperazine . The chemotherapeutic regimens given included the following drugs in various combinations : Cis-platinum , vincristine , cyelophosphamide , adriamycin , vinde-sine , and etoposide ( VP16 ) . Nabilone was significantly superior to prochlorperazine in the reduction of vomiting episodes . Side effects , mainly vertigo , were evident in nearly half of the patients after nabilone , and three patients were withdrawn from the study due to decreased coordination and hallucinations after nabilone . Side effects from prochlorperazine were limited to mild drowsiness in one patient . Two-thirds of the patients preferred nabilone to prochlorperazine . We conclude that nabilone is a moderately effective anti-emetic drug , but that the unpredictability of its side effects call for careful patient information , especially with elderly out patients . We recommend that at least after the first dose of nabilone , the patient should be kept under close observation during 4 hours Eighty evaluable patients receiving chemotherapy were entered on a r and om prospect i ve double-blind study to evaluate the effectiveness of nabilone , a synthetic cannabinoid , compared to prochlorperazine . Most of these patients received cisplatin , a drug that universally produces severe nausea and vomiting , as part of a combination chemotherapy regimen . The patients served as their own controls , receiving either nabilone or prochlorperazine during two consecutive treatment courses with the identical chemotherapy . Side effects consisting of hypotension and lethargy were more pronounced with nabilone . Toxicity , in general , did not preclude antiemetic treatment and in no way interfered with chemotherapy . Sixty patients ( 75 per cent ) reported nabilone to be more effective than prochlorperazine for relief of nausea and vomiting . Of these 60 patients , 46 required further chemotherapy and continued taking nabilone as the antiemetic of choice A r and om- sample , anonymous survey of the members of the American Society of
Output:
| Cannabinoids were not more effective in patients receiving very low or very high emetogenic chemotherapy .
In selected patients , the cannabinoids tested in these trials may be useful as mood enhancing adjuvants for controlling chemotherapy related sickness . |
MS213184 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: CONTEXT Talking about death can be difficult . Without evidence that end-of-life discussion s improve patient outcomes , physicians must balance their desire to honor patient autonomy against a concern of inflicting psychological harm . OBJECTIVE To determine whether end-of-life discussion s with physicians are associated with fewer aggressive interventions . DESIGN , SETTING , AND PARTICIPANTS A US multisite , prospect i ve , longitudinal cohort study of patients with advanced cancer and their informal caregivers ( n = 332 dyads ) , September 2002-February 2008 . Patients were followed up from enrollment to death , a median of 4.4 months later . Bereaved caregivers ' psychiatric illness and quality of life was assessed a median of 6.5 months later . MAIN OUTCOME MEASURES Aggressive medical care ( eg , ventilation , resuscitation ) and hospice in the final week of life . Secondary outcomes included patients ' mental health and caregivers ' bereavement adjustment . RESULTS One hundred twenty-three of 332 ( 37.0 % ) patients reported having end-of-life discussion s before baseline . Such discussion s were not associated with higher rates of major depressive disorder ( 8.3 % vs 5.8 % ; adjusted odds ratio [ OR ] , 1.33 ; 95 % confidence interval [ CI ] , 0.54 - 3.32 ) , or more worry ( mean McGill score , 6.5 vs 7.0 ; P = .19 ) . After propensity-score weighted adjustment , end-of-life discussion s were associated with lower rates of ventilation ( 1.6 % vs 11.0 % ; adjusted OR , 0.26 ; 95 % CI , 0.08 - 0.83 ) , resuscitation ( 0.8 % vs 6.7 % ; adjusted OR , 0.16 ; 95 % CI , 0.03 - 0.80 ) , ICU admission ( 4.1 % vs 12.4 % ; adjusted OR , 0.35 ; 95 % CI , 0.14 - 0.90 ) , and earlier hospice enrollment ( 65.6 % vs 44.5 % ; adjusted OR , 1.65;95 % CI , 1.04 - 2.63 ) . In adjusted analyses , more aggressive medical care was associated with worse patient quality of life ( 6.4 vs 4.6 ; F = 3.61 , P = .01 ) and higher risk of major depressive disorder in bereaved caregivers ( adjusted OR , 3.37 ; 95 % CI , 1.12 - 10.13 ) , whereas longer hospice stays were associated with better patient quality of life ( mean score , 5.6 vs 6.9 ; F = 3.70 , P = .01 ) . Better patient quality of life was associated with better caregiver quality of life at follow-up ( beta = .20 ; P = .001 ) . CONCLUSIONS End-of-life discussion s are associated with less aggressive medical care near death and earlier hospice referrals . Aggressive care is associated with worse patient quality of life and worse bereavement adjustment IMPORTANCE Advance care planning can improve patient-centered care and potentially reduce intensification of care at the end of life . OBJECTIVES To inquire about patients ' advance care planning activities before hospitalization and preferences for care from the perspectives of patients and family members , as well as to measure real-time concordance between expressed preferences for care and documentation of those preferences in the medical record . DESIGN Prospect i ve study . SETTING Twelve acute care hospitals in Canada . PARTICIPANTS Elderly patients who were at high risk of dying in the next 6 months and their family members . MAIN OUTCOME MEASURES Responses to an in-person administered question naire and concordance of expressed preferences and orders of care documented in the medical record . RESULTS Of 513 patients and 366 family members approached , 278 patients ( 54.2 % ) and 225 family members ( 61.5 % ) consented to participate . The mean ages of patients and family members were 80.0 and 60.8 years , respectively . Before hospitalization , most patients ( 76.3 % ) had thought about end-of-life ( EOL ) care , and only 11.9 % preferred life-prolonging care ; 47.9 % of patients had completed an advance care plan , and 73.3 % had formally named a surrogate decision maker for health care . Of patients who had discussed their wishes , only 30.3 % had done so with the family physician and 55.3 % with any member of the health care team . Agreement between patients ' expressed preferences for EOL care and documentation in the medical record was 30.2 % . Family members ' perspectives were similar to those of patients . CONCLUSIONS AND RELEVANCE Many elderly patients at high risk of dying and their family members have expressed preferences for medical treatments at the EOL . However , communication with health care professionals and documentation of these preferences remains inadequate . Efforts to reduce this significant medical error of omission are warranted OBJECTIVE : To describe how medical residents discuss do-not-resuscitate ( DNR ) orders with patients . DESIGN : Prospect i ve observational study . SETTING : Inpatient medical wards of one university tertiary care center , one urban city public hospital , and one Veterans Affairs medical center . PARTICIPANTS : Thirty-one medical residents self-selected 31 of their English-speaking , competent patients , with whom they had DNR discussion s. MEASUREMENTS : Three independent observers rated audiotaped discussion s about DNR orders between the medical residents and their patients . Ratings assessed whether the physicians met st and ard criteria for requesting informed consent ( e.g. , disclosed the nature , benefits , risks , and outcomes ) , addressed the patients ’ values , and attended to the patients ’ emotional concerns . MAIN RESULTS : The physicians often did not provide essential information about cardiopulmonary resuscitation ( CPR ) . While all the physicians mentioned mechanical ventilation , only 55 % mentioned chest compressions and 32 % mentioned intensive care . Only 13 % of the physicians mentioned the patient ’s likelihood of survival after CPR , and no physician used a numerical estimate . The discussion s lasted a median of 10 minutes and were dominated in speaking time by the physicians . The physicians initiated discussion s about the patients ’ personal values and goals of care in 10 % of the cases , and missed opportunities to do so . CONCLUSIONS : Medical ethicists , professional societies , and the public recommend more frequent discussion s about DNR orders . Even when housestaff discuss resuscitation with patients , they may not be accomplishing the goal of increasing patient autonomy . Research and education must focus on improving the quality , as well as the quantity , of these discussion Objective : To evaluate the effect of an intervention on the underst and ing and use of DNR orders by physicians ; to assess the impact of underst and ing the importance of involving competent patients in DNR decisions . Design : Prospect i ve clinical interventional study . Setting : Internal medicine department ( 70 beds ) of the hospital of La Chaux-de-Fonds , Switzerl and . Participants : Nine junior physicians in postgraduate training . Intervention : Information on the ethics of DNR and implementation of new DNR orders . Measurements and main results : Accurate underst and ing , interpretation , and use of DNR orders , especially with respect to the patients ’ involvement in the decision were measured . Junior doctors writing DNR orders had an extremely poor underst and ing of what DNR orders mean . The correct underst and ing of the definition of a DNR order increased from 31 to 93 % ( p<0.01 ) after the intervention and the patients ’ involvement went from 17 % to 48 % ( p<0.01 ) . Physicians estimated that 75 % of their DNR patients were mentally competent at the time of the decision . Conclusion : An intervention aim ed at explaining the ethical principles and the definition of DNR orders improves underst and ing of them , and their implementation , as well as patient participation . Specific efforts are needed to increase the involvement of mentally competent patients in the decision PURPOSE To evaluate the effectiveness of binary content checklists in measuring increasing levels of clinical competence . METHOD Fourteen clinical clerks , 14 family practice residents , and 14 family physicians participated in two 15-minute st and ardized patient interviews . An examiner rated each participant 's performance using a binary content checklist and a global process rating . The participants provided a diagnosis two minutes into and at the end of the interview . RESULTS On global scales , the experienced clinicians scored significantly better than did the residents and clerks , but on checklists , the experienced clinicians scored significantly worse than did the residents and clerks . Diagnostic accuracy increased for all groups between the two-minute and 15-minute marks without significant differences between the groups . CONCLUSION These findings are consistent with the hypothesis that binary checklists may not be valid measures of increasing clinical competence ABSTRACT BACKGROUND The quality of code status discussion s ( CSDs ) is suboptimal as physicians often fail to discuss patients ’ goals of care and resuscitation outcomes . We previously demonstrated that internal medicine residents r and omized to a communication skills intervention scored higher than controls on a CSD checklist using a st and ardized patient . However , the impact of this training on CSD content is unknown . OBJECTIVE Compare CSD content between intervention and control residents . DESIGN We conducted qualitative analysis of simulated CSDs . Augmenting a priori codes with constant comparative analysis , we identified key themes associated with resident determination of code status . We dichotomized each theme as present or absent . We used chi-square tests to evaluate the association between training and presence of each theme . PARTICIPANTS Fifty-six residents rotating on the internal medicine service in July 2010 were r and omized to intervention ( n = 25 ) or control ( n = 31).INTERVENTIONIntervention residents completed CSD skills training ( lectures , deliberate practice , and self- study ) . Six months later , all 56 residents completed a simulated CSD.MAIN MEASUREComparison of key themes identified in CSDs among intervention and controls . KEY RESULTS Fifty-one transcripts were recorded and review ed . Themes identified included : exploration of patient values/ goals , framing code status as a patient decision , discussion of resuscitation outcomes and quality of life , and making a recommendation regarding code status . Intervention residents were more likely than controls to explore patient values/ goals ( p = 0.002 ) and make a recommendation ( p < 0.001 ) ; and less likely to frame the decision as one solely to be made by the patient ( p = 0.01 ) . Less than one-third of residents discussed resuscitation outcomes or quality of life . CONCLUSION Training positively influenced CSD content in key domains , including exploration of patient values/ goals , making a recommendation regarding code status , and not framing code status as solely a patient decision . However , despite the intervention , residents infrequently discussed resuscitation outcomes and quality of life Discussing end-of-life decisions with cancer patients is a crucial skill for physicians . This article reports findings from a pilot study evaluating the effectiveness of a computer-based decision aid for teaching medical students about advance care planning . Second-year medical students at a single medical school were r and omized to use a st and ard advance directive or a computer-based decision aid to help patients with advance care planning . Students ' knowledge , skills , and satisfaction were measured by self-report ; their performance was rated by patients . 121/133 ( 91 % ) of students participated . The Decision-Aid Group ( n = 60 ) outperformed the St and ard Group ( n = 61 ) in terms of students ´ knowledge ( p < 0.01 ) , confidence in helping patients with advance care planning ( p < 0.01 ) , knowledge of what matters to patients ( p = 0.05 ) , and satisfaction with their learning experience ( p < 0.01 ) . Likewise , patients in the Decision Aid Group were more satisfied with the advance care planning method ( p < 0.01 ) and with several aspects of student performance . Use of a computer-based decision aid may be an effective way to teach medical students how to discuss advance care planning with cancer patients BACKGROUND Internal medicine residents are largely unprepared to carry out end-of-life ( EOL ) conversations . There is evidence that these skills can be taught , but data from r and omized controlled trials are lacking . PURPOSE We studied whether a day-long communication skills training retreat would lead to enhanced performance of and confidence with specific EOL conversations . We also studied the effect of the retreat on residents ' ability to respond to patient emotions . METHODS PGY-2 resident volunteers were r and omly assigned to a retreat group or a control group . The retreat involved a combination of teaching styles and skills practice with st and ardized patients . All participants completed question naires and were evaluated carrying out two types of conversations ( breaking bad news or discussing direction of care ) with a st and ardized patient before ( T1 ) and after ( T2 ) the intervention phase . Conversations were audio-taped and later rated by a research er blinded to group assignment and time of assessment . RESULTS Forty-nine residents agreed to r and omization ( 88 % ) with 23 residents r and omized to the retreat group and 26 to the control group . Compared to controls , retreat participants demonstrated higher T2 scores for breaking bad news , discussing direction of care , and responding to emotion . Comparing T2 to T1 , the retreat group 's improvement in responding to emotion was statistically significant . The retreat group 's confidence improved significantly only for the breaking bad news construct . CONCLUSIONS A short course for residents can significantly improve specific elements of resident EOL conversation performance , including the ability to respond to emotional cues IMPORTANCE Communication about end-of-life care is a core clinical skill . Simulation-based training improves skill acquisition , but effects on patient-reported outcomes are unknown . OBJECTIVE To assess the effects of a communication skills intervention for internal medicine and nur
Output:
| Conclusion Very low to low quality evidence suggests that end-of-life communication training may improve healthcare professionals ’ self-efficacy , knowledge , and EoL communication scores compared to usual teaching . |
MS213185 | ***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 Objective : To evaluate a palliative care home support team based on an inpatient unit . Design : R and omised controlled trial with waiting list . Patients in the study group received the service immediately , those in the control group received it after one month . Main comparison point was at one month . Setting - A city of 300 000 people with a publicly funded home care service and about 200 general practitioners , most of whom provide home care . Main outcome measures : Pain and nausea levels were measured at entry to trial and at one month , as were quality of life for patients and care givers ' health . Results : Because of early deaths , problems with recruitment , and a low compliance rate for completion of question naires , the required sample size was not attained . Conclusion : In design ing evaluations of palliative care services , investigators should be prepared to deal with the following issues : attrition due to early death , opposition to r and omisation by patients and referral sources , ethical problems raised by r and omisation of dying patients , the appropriate timing of comparison points , and difficulties of collecting data from sick or exhausted patients and care givers . Investigators may choose to evaluate a service from various perspectives using different methods : controlled trials , qualitative studies , surveys , and audits . R and omised trials may prove to be impracticable for evaluation of palliative care OBJECTIVE To evaluate the use of a multidisciplinary record held by patients with cancer in the community . DESIGN Pragmatic r and omised controlled trial . SETTING The environs of Swansea in south west Wales . PARTICIPANTS 501 patients under the care of the Department of Oncology , Singleton Hospital , Swansea . INTERVENTION A patient held record used by the patient and healthcare professionals . Main outcome measures -Health related quality of life ( EORTC QLQ-C30 ) measured at entry into the study and at 6 months ; patients ' views at 6 months ; healthcare professionals ' views collected after the completion of patient follow up ; NHS re source and booklet use . RESULTS 1148 patients were eligible for the study ; 501 were recruited ( 44 % ) and 344 completed the study ( 172 in each group ) . There was no significant difference between the two groups in change in quality of life or NHS re source use . The patient held record did not have an impact on communication but was significantly helpful to patients in preparing for appointments , reducing difficulties in monitoring their own progress , and helping them to feel more in control ( p<0.05 ) . Fifty three percent of patients would have preferred not to have a patient held record . There was a low level of use of the record by healthcare professionals but most of those who remembered using it indicated that they would prefer patients to have it . CONCLUSIONS The patient held record is valued by some patients and professionals but has no significant impact on the quality of life of patients or NHS re source use . It has a positive impact on quality by helping patients feel more in control and prepare for meetings with healthcare staff . Patients who find it useful tend to be younger and have more professionals involved in their care . It is recommended that it should be made available to patients on request and used by them according to need A logbook , or patient-dossier , was developed , to improve continuity of information in the treatment and care of head- and -neck cancer patients . It contained information modules on different aspects of care , as well as forms to facilitate communication both between patient and care-professional and between the various care-professionals . The logbook 's effectiveness was evaluated in two hospitals in Rotterdam , by comparing outcomes for trial and comparison groups of , respectively , 71 and 54 patients and 59 and 35 care-professionals . Trial patients proved to be better informed , to receive more support and to experience fewer psychosocial problems . Professionals who used the logbook were better informed about their patients , and about the care-activities of fellow-professionals than those who did not . They recognised an improvement in their contact with colleagues and in the harmonisation of their respective care-activities BACKGROUND The burden of cancer care in general practice is increasing . Patient-held records may facilitate effective , coordinated care , but no r and omised controlled trials of their use in cancer care have been conducted , and concerns about possible negative effects remain . AIM To evaluate the use of a supplementary patient-held record in cancer care . METHOD Six hundred and fifty radiotherapy out patients with any form of cancer were r and omised either to hold a supplementary record or to receive normal care . It was explained to record holders that the supplementary record was intended to improve communication with health professionals and act as an aide memoire . After three months , patients ' satisfaction with communication and with participation in their own care were assessed . Global health status , emotional functioning , and cognitive functioning were measured using the European Organization for Research and Treatment of Cancer QLQ-C30 question naire . RESULTS There were no significant differences between groups in any of the outcome measures . Patients in both groups expressed a high level of satisfaction with communication and participation in their care . Mean ( SD ) scores in the intervention and control groups were : global health status , 66.8 ( 24.2 ) and 65.3 ( 23.7 ) ; emotional functioning , 75.0 ( 24.6 ) and 77.4 ( 22.8 ) ; cognitive functioning , 84.5 ( 21.0 ) and 84.0 ( 21.3 ) . CONCLUSION A supplementary patient-held record for radiotherapy out patients appears to have no effect on satisfaction with communication , participation in care , or quality of life The objective of this study was to evaluate a patient-held record ( PHR ) for patients with cancer . A r and omized controlled trial ( RCT ) was conducted of a PHR to be used by patients newly diagnosed with lung or colorectal cancer ( hospital ) , patients with cancer at any stage ( community ) and professionals involved in their care , together with surveys of health professionals to gauge views on PHR . Main outcome measures were patient satisfaction with information and communication , and patient and healthcare professionals ' views of PHR . The only significant difference was 86 % of control compared with 58 % of intervention patients were very satisfied with information received at the end of treatment ( odds ratio 4.4 , 95 % confidence interval 1.2 - 15.6 , P < 0.05 ) . Fifty-three per cent of intervention respondents found the PHR helpful ( 63 % hospital vs. 38 % community patients ) , and 69 % felt that it would be useful to them in the future . Primary healthcare ( PHC ) professionals found the PHR of more benefit than those working in hospitals ( P < 0.05 ) . The PHR did not improve measures of patient satisfaction with information or communication . Despite its limited use by many health professionals , the PHR was well received by recently diagnosed patients , and those who did not receive negative responses to it from staff involved in their care . It was also positively valued by staff in PHC . An evaluation of a customized record provided at the time of diagnosis is warranted The Patient Care Travelling Record ( PCTR ) is a passport-like health-care summary that , in previous research by the authors , has been found to be a feasible and acceptable tool to convey important clinical information about the palliative care patient . This r and omized controlled trial was conducted to determine the effectiveness and efficiency of this Record in improving patient mood , decreasing uncertainty , improving satisfaction with health care , reducing use of health-care services , and maximizing pain control . Eligible patients were r and omized to receive or not receive the PCTR ( completed by nurse or physician and review ed jointly with the patient ) . As baseline entry into the study and then at 1 and 2 months , patients completed measures on level of certainty , mood states , satisfaction with care , levels of pain , and health-care services utilization . During the 2-year study period , only 20 % ( N = 61 ) of the patients enrolled in a palliative care program in Southern Ontario were eligible for the trial . Of these patients , 18 died , 15 declined to participate , and 7 were emotionally unable to complete the question naires . Thus 21 patients completed the trial . With the exception of those age 65 years and over , the patients using the Record reported decreased levels of uncertainty on follow-up . There was no additional use of health-care services , no differences in mood states , pain relief , or satisfaction with health care . It is significant that 80 % of palliative patients were not eligible because their physical and psychological status rendered them insufficiently stable to participate in a research study . Because of their vulnerable status , these patients may be ideal for the utilization of the Record in clinical care . Although research in this palliative care population is challenging due to difficulties with recruitment and high dropout rates due to death , the PCTR , which was previously shown to be acceptable and feasible , has now been shown to be effective in reducing patient uncertainty , specifically for adults under 65 years . Indications for future research are described
Output:
| R and omized trials found an absence of effect , non-experimental evaluations shed light on the conditions for its successful use .
Most patients welcomed introduction of a PHR .
Main problems related to its suitability for different patient groups and the lack of agreement between patients and health professionals regarding its function . |
MS213186 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background and Purpose — After stroke and transient ischemic attack there is a high early risk of recurrent stroke , particularly in large artery disease . It has been suggested more intensive antiplatelet regimens are required , but trial data are lacking . Treatment efficacy can be evaluated using transcranial Doppler detection of embolic signals . Ambulatory transcranial Doppler has recently been developed ; prolonged recording may reduce subject numbers required to determine therapeutic efficacy . In a r and omized trial ( IS RCT N68019845 ) with blinded end point evaluation , we determined whether treatment with dipyridamole or clopidogrel , in addition to aspirin , was more effective at reducing embolization . Methods — Consecutive patients with recent symptomatic carotid stenosis were recruited . Ambulatory transcranial Doppler and platelet aggregometry were performed at baseline and 48 hours . Patients , all on aspirin , were r and omized to dipyridamole or clopidogrel . Recordings were analyzed offline masked to subject identity . Results — Sixty patients were recruited , 30 in each arm . The primary end point of change in embolic signal frequency did not differ between groups ( P=0.36 ) . In patients with embolic signals at baseline , there was no difference in reduction in embolic signal frequency : dipyridamole ( 75.5 ; SD 17.7 % ) versus clopidogrel ( 77.5 ; SD 20.5 % ; P=0.77 ) . Baseline platelet aggregation was not different between regimens , but at 48 hours , adenosine 5′-diphosphate aggregation rate ( but not collagen ) was lower with clopidogrel ( P<0.001 ) . Conclusions — Both dipyridamole and clopidogrel reduced embolization to a similar extent . Embolic signals are strong predictors of future stroke rate in this patient group . Our results suggest these 2 treatment regimens have similar efficacy in early secondary prevention of stroke , although this now needs testing in large Phase III trials The PFA-100 system is a platelet function analyzer design ed to measure platelet-related primary hemostasis . The instrument uses two disposable cartridges : a collagen/epinephrine ( CEPI ) and a collagen/ADP ( CADP ) cartridge . Previous experience has shown that CEPI cartridges detect qualitative platelet defects , including acetylsalicylic acid (ASA)-induced abnormalities , while CADP cartridges detect only thrombocytopathies and not ASA use . In this seven-center trial , 206 healthy subjects and 176 persons with various platelet-related defects , including 127 ASA users , were studied . The platelet function status was determined by a platelet function test panel . Comparisons were made as to how well the defects were identified by the PFA-100 system and by platelet aggregometry . The reference intervals for both cartridges , testing the 206 healthy subjects , were similar to values described in smaller studies in the literature [ mean closure time ( CT ) 132 s for CEPI and 93 s for CADP ] . The use of different lot numbers of cartridges or duplicate versus singleton testing revealed no differences . Compared with the platelet function status , the PFA-100 system had a clinical sensitivity of 94.9 % and a specificity of 88.8 % . For aggregometry , a sensitivity of 94.3 % and a specificity of 88.3 % were obtained . These values are based on all 382 specimens . A separate analysis of sensitivity by type of platelet defect , ASA use versus congenital thrombocytopathies , revealed for the PFA-100 system a 94.5 % sensitivity in identifying ASA users and a 95.9 % sensitivity in identifying the other defects . For aggregometry , the values were 100 % for ASA users and 79.6 % for congenital defects . Analysis of concordance between the PFA-100 system and aggregometry revealed no difference in clinical sensitivity and specificity between the systems ( p > 0.9999 ) . The overall agreement was 87.5 % , with a Kappa index of 0.751 . The two tests are thus equivalent in their ability to identify normal and abnormal platelet defects . Testing 126 subjects who took 325 mg ASA revealed that the PFA-100 system ( CEPI ) was able to detect 71.7 % of ASA-induced defects with a positive predictive value of 97.8 % . The overall clinical accuracy of the system , calculated from the area under the ROC curve , was 0.977 . The data suggest that the PFA-100 system is highly accurate in discriminating normal from abnormal platelet function . The ease of operation of the instrument makes it a useful tool to use in screening patients for platelet-related hemostasis defects Background and Purpose — The annual risk of ischemic stroke distal to ≥50 % asymptomatic carotid stenoses was ≈2 % to 3 % in early cohort studies and subsequent r and omized trials of endarterectomy . This risk might have fallen in recent years owing to improvements in medical treatment , but there are no published prognostic data from studies initiated within the last 10 years . Methods — In a population -based study of all patients with transient ischemic attack ( TIA ) or stroke in the Oxford Vascular Study , we studied the risk of TIA and stroke in patients with ≥50 % contralateral asymptomatic carotid stenoses recruited consecutively from 2002 to 2009 and given intensive contemporary medical treatment . Results — Of 1153 consecutively imaged patients presenting with stroke or TIA , 101 ( 8.8 % ) had ≥50 % asymptomatic carotid stenoses ( mean age , 75 years ; 39 % women ; 40 % age ≥80 years ) . During 301 patient-years of follow-up ( mean , 3 years ) , there were 6 ischemic events in the territory of an asymptomatic stenosis , 1 minor stroke ( initially 50 % to 69 % stenosis ) , and 5 TIAs ( 2 initially 50 % to 69 % stenosis ; 3 to 70 % to 99 % stenosis ) , 3 of which led to subsequent endarterectomy . The average annual event rates on medical treatment were 0.34 % ( 95 % CI , 0.01 to 1.87 ) for any ipsilateral ischemic stroke , 0 % ( 95 % CI , 0.00 to 0.99 ) for disabling ipsilateral stroke , and 1.78 % ( 95 % CI , 0.58 to 4.16 ) for ipsilateral TIA . Conclusions — In the first study of the prognosis of ≥50 % asymptomatic carotid stenosis to be initiated in the last 10 years , the risk of stroke on intensive contemporary medical treatment was low . Larger studies are required to determine whether this apparent improvement in prognosis is generalizable BACKGROUND Few r and omised clinical trials have investigated the use of antithrombotic drugs for early secondary prevention of stroke or transient ischaemic attack in patients with intracranial atherosclerotic stenosis . Microembolic signals , detected by transcranial doppler , are a surrogate marker of future stroke risk and have been used to show treatment efficacy in patients with extracranial carotid stenosis . We aim ed to investigate whether treatment with clopidogrel plus aspirin reduced the number of microembolic signals detected with transcranial doppler ultrasound compared with aspirin alone in patients with recent stroke . METHODS The clopidogrel plus aspirin for infa rct ion reduction in acute stroke or transient ischaemic attack patients with large artery stenosis and microembolic signals ( CLAIR ) trial was a r and omised , open-label , blinded-endpoint trial . Between Oct 28 , 2003 , and Nov 19 , 2008 , patients with acute ischaemic stroke or transient ischaemic attack who had symptomatic large artery stenosis in the cerebral or carotid arteries and in whom microembolic signals were present on transcranial doppler were r and omly assigned within 7 days of symptom onset to receive clopidogrel ( 300 mg for the first day , then 75 mg daily ) plus aspirin ( 75 - 160 mg daily ) or aspirin alone ( 75 - 160 mg daily ) for 7 days . Patients were r and omly assigned in blocks of four or six by use of a r and omisation website . Monitoring of microembolic signals on transcranial doppler was done on days 2 and 7 . The primary endpoint was the proportion of patients who had microembolic signals on day 2 . Analysis was by modified intention to treat . All analyses were done by an investigator masked to both patient identity and the day the recording was taken . This trial is registered with the Centre for Clinical Trials , Chinese University of Hong Kong , number CUHK_CCT00164 . FINDINGS 100 patients were r and omly assigned to clopidogrel plus aspirin ( n=47 ) or aspirin monotherapy ( n=53 ) . 93 of 100 patients had symptomatic intracranial stenosis in either the intracranial internal carotid artery or the middle cerebral artery : 45 of 46 in the dual therapy group and 48 of 52 in the monotherapy group . At day 2 , 14 of 45 patients in the dual therapy group and 27 of 50 patients in the monotherapy group for whom data were available had at least one microembolic signal on transcranial doppler ( relative risk reduction 42.4 % , 95 % CI 4.6 - 65.2 ; p=0.025 ) . Adverse events were similar in the two groups . No patients had intracranial or severe systemic haemorrhage , but two patients in the dual therapy group had minor haemorrhages . INTERPRETATION Combination therapy with clopidogrel and aspirin is more effective than aspirin alone in reducing microembolic signals in patients with predominantly intracranial symptomatic stenosis . Clinical trials are now warranted to investigate whether this combination treatment also results in a reduction in stroke incidence Background — Evidence for efficacy of dual antiplatelet therapy in stroke is limited . Symptomatic carotid stenosis patients are at high risk of early recurrent stroke . In this group , asymptomatic microembolic signals ( MES ) , detected by transcranial Doppler ultrasound ( TCD ) , are markers of future stroke and transient ischemic attack ( TIA ) risk . They offer a surrogate marker to evaluate antiplatelet therapy , but no multicenter study has evaluated the feasibility of this approach . Methods and Results —Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis ( CARESS ) is a r and omized , double-blind study in subjects with recently symptomatic ≥50 % carotid stenosis . Patients were screened with TCD , and if MES were detected , they were r and omized to clopidogrel and aspirin or aspirin monotherapy . Repeated TCD recordings were made on days 2 and 7 . MES were detected in 110 of 230 patients by online analysis at baseline , of whom 107 were r and omized . Intention-to-treat analysis revealed a significant reduction in the primary end point : 43.8 % of dual-therapy patients were MES positive on day 7 , as compared with 72.7 % of monotherapy patients ( relative risk reduction 39.8 % ; 95 % CI , 13.8 to 58.0 ; P=0.0046 ) . The secondary end point of MES frequency per hour was reduced ( compared with baseline ) by 61.4 % ( 95 % CI , 31.6 to 78.2 ; P=0.0013 ) in the dual-therapy group at day 7 and by 61.6 % ( 95 % CI , 34.9 to 77.4 ; P=0.0005 ) on day 2 . There were 4 recurrent strokes and 7 TIAs in the monotherapy group versus no stroke and 4 TIAs in the dual-therapy group that were treatment emergent and ipsilateral to the qualifying carotid stenosis ; 2 additional ipsilateral TIAs occurred before treatment started . MES frequency was greater in the 17 patients with recurrent ipsilateral events compared with the 90 without ( mean±SD : 24.4±27.7 versus 8.9±11.5 per hour ; P=0.0003 ) . Conclusions —In patients with recently symptomatic carotid stenosis , combination therapy with clopidogrel and aspirin is more effective than aspirin alone in reducing asymptomatic embolization . Doppler MES detection is a feasible method to evaluate the efficacy of antiplatelet therapy in multicenter studies Background —Postoperative thromboembolic stroke affects 2 % to 3 % of patients undergoing carotid endarterectomy ( CEA ) and is preceded by 1 to 2 hours of increasing cerebral embolization . Previous work has demonstrated that high rates of postoperative embolization are associated with increased platelet reactivity to adenosine 5′-diphosphate ( ADP ) . Our hypothesis was that preoperative administration of the platelet ADP antagonist clopidogrel could reduce postoperative embolization . Methods and Results —One hundred CEA patients on routine aspirin therapy ( 150 mg ) were r and omized to 75 mg clopidogrel ( n=46
Output:
| Furthermore , pilot data suggest that platelet activation may be increased in recently symptomatic than in asymptomatic severe carotid stenosis .
Excessive platelet activation and platelet hyperreactivity may play a role in the pathogenesis of first or subsequent transient ischemic attack or stroke in patients with moderate or severe carotid stenosis . |
MS213187 | ***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: OBJECTIVE The purpose of this pilot study was to test the effects of guided imagery on blood loss during the third stage of labor . DESIGN AND SETTING This was a three-group r and omized controlled trial . Recruitment was conducted from a university nurse-midwifery practice . SUBJECTS Sixty ( 60 ) women between pregnancy weeks 36 and 38 participated . INTERVENTIONS The women were r and omized into experimental , placebo , and control groups . OUTCOME MEASURES Intrauterine pressure catheters were used to measure uterine contraction frequency and intensity . Blood loss was measured . Analysis of variance was used to compare the three groups on continuous variables . RESULTS Complete data were collected on 41 subjects . No significant differences were found among the groups on demographic or potentially confounding variables . CONCLUSIONS Blood loss was nominally lower in the experimental group , but conclusions can not be drawn due to the sample size This study examined the effects of a yoga program during pregnancy , on maternal comfort , labor pain , and birth outcomes . A r and omized trial was conducted using 74-primigravid Thai women who were equally divided into two groups ( experimental and control ) . The yoga program involved six , 1-h sessions at prescribed weeks of gestation . A variety of instruments were used to assess maternal comfort , labor pain and birth outcomes . The experimental group was found to have higher levels of maternal comfort during labor and 2h post-labor , and experienced less subject evaluated labor pain than the control group . In each group , pain increased and maternal comfort decreased as labor progressed . No differences were found , between the groups , regarding pethidine usage , labor augmentation or newborn Apgar scores at 1 and 5 min . The experimental group was found to have a shorter duration of the first stage of labor , as well as the total time of labor Two studies were conducted to examine the effects of music on analogued labor pain using volunteer nulliparous subjects who were r and omly assigned to treatment groups ( n = 10 per group ) . Assessment s of the treatments were made in a 1-hour session involving twenty 80-second exposures to a laboratory pain stimulus patterned to resemble labor contractions . In the first experiment , it was hypothesized that subjects listening to easy-listening music would report lower pain ratings and cardiovascular responses than subjects listening to rock music , self-selected music , or a dissertation ( placebo-attention ) and subjects in a no-treatment control group . No significant group effects were found ; significant time effects were found for heart rate , systolic and diastolic blood pressure . Subjects spontaneously reported using imagery as a pain reduction technique . In the second study a combination of music and imagery was examined by r and omly assigning subjects to one of five groups : self-generated imagery with music ( SIM ) , guided imagery with music ( GIM ) , self-generated imagery without music ( SI ) , guided imagery without music ( GI ) , or no-treatment control . Again , no significant group effects were obtained . Significant time effects were obtained for heart rate , systolic and diastolic blood pressure CONTEXT A prior national survey documented the high prevalence and costs of alternative medicine use in the United States in 1990 . OBJECTIVE To document trends in alternative medicine use in the United States between 1990 and 1997 . DESIGN Nationally representative r and om household telephone surveys using comparable key questions were conducted in 1991 and 1997 measuring utilization in 1990 and 1997 , respectively . PARTICIPANTS A total of 1539 adults in 1991 and 2055 in 1997 . MAIN OUTCOMES MEASURES Prevalence , estimated costs , and disclosure of alternative therapies to physicians . RESULTS Use of at least 1 of 16 alternative therapies during the previous year increased from 33.8 % in 1990 to 42.1 % in 1997 ( P < or = .001 ) . The therapies increasing the most included herbal medicine , massage , megavitamins , self-help groups , folk remedies , energy healing , and homeopathy . The probability of users visiting an alternative medicine practitioner increased from 36.3 % to 46.3 % ( P = .002 ) . In both surveys alternative therapies were used most frequently for chronic conditions , including back problems , anxiety , depression , and headaches . There was no significant change in disclosure rates between the 2 survey years ; 39.8 % of alternative therapies were disclosed to physicians in 1990 vs 38.5 % in 1997 . The percentage of users paying entirely out-of-pocket for services provided by alternative medicine practitioners did not change significantly between 1990 ( 64.0 % ) and 1997 ( 58.3 % ) ( P=.36 ) . Extrapolations to the US population suggest a 47.3 % increase in total visits to alternative medicine practitioners , from 427 million in 1990 to 629 million in 1997 , thereby exceeding total visits to all US primary care physicians . An estimated 15 million adults in 1997 took prescription medications concurrently with herbal remedies and /or high-dose vitamins ( 18.4 % of all prescription users ) . Estimated expenditures for alternative medicine professional services increased 45.2 % between 1990 and 1997 and were conservatively estimated at $ 21.2 billion in 1997 , with at least $ 12.2 billion paid out-of-pocket . This exceeds the 1997 out-of-pocket expenditures for all US hospitalizations . Total 1997 out-of-pocket expenditures relating to alternative therapies were conservatively estimated at $ 27.0 billion , which is comparable with the projected 1997 out-of-pocket expenditures for all US physician services . CONCLUSIONS Alternative medicine use and expenditures increased substantially between 1990 and 1997 , attributable primarily to an increase in the proportion of the population seeking alternative therapies , rather than increased visits per patient Objective . To study whether use of psychoprophylaxis during labor affects course of labor and experience of childbirth in nulliparous women . Design . Cohort study . Setting . Women were recruited from 15 antenatal clinics in Sweden between October 2005 and January 2007 . Sample . A total of 857 nulliparous women with a planned vaginal delivery . Methods . Using data from a r and omized controlled trial of antenatal education where the allocated groups were merged , we compared course of labor and experience of childbirth between women who used psychoprophylaxis during labor and those who did not . Data were collected by question naires in mid‐pregnancy and three months after birth , and from the Swedish Medical Birth Register . Logistic regression was used to assess associations . Main outcome measures . Mode of delivery , augmentation of labor , length of labor , Apgar score , pain relief and experience of childbirth as measured by the Wijma Delivery Experience Question naire . Results . Use of psychoprophylaxis during labor was associated with a lower risk of emergency cesarean section ( adjusted odds ratio ( OR ) 0.57 ; 95 % confidence interval ( CI ) 0.37–0.88 ) , but an increased risk of augmentation of labor ( adjusted OR 1.68 ; 95 % CI 1.23–2.28 ) . No statistical differences were found in length of labor ( adjusted OR 1.32 ; 95 % CI 0.95–1.83 ) , Apgar score < 7 at five minutes ( adjusted OR 0.82 ; 95 % CI 0.33–2.01 ) , epidural analgesia ( adjusted OR 1.13 ; 95 % CI 0.84–1.53 ) or fearful childbirth experience ( adjusted OR 1.04 ; 95 % CI 0.62–1.74 ) . Conclusion . Psychoprophylaxis may reduce the rate of emergency cesarean section but may not affect the experience of childbirth OBJECTIVE to evaluate a yoga programme provided to primigravidas in the third trimester of pregnancy with the aim of decreasing the discomforts associated with pregnancy and increasing childbirth self-efficacy . DESIGN non-r and omised controlled experimental study . SETTING a hospital in northern Taiwan . PARTICIPANTS the target population was primigravidas at 26 - 28 weeks of gestation ( no high-risk pregnancies ) who had not engaged in regular exercise or yoga for at least one year . The study included 88 individuals ; 43 in the control group and 45 in the experimental group who took part in the prenatal yoga programme . INTERVENTION the duration of the prenatal yoga programme was 12 - 14 weeks , with at least three sessions per week . Each workout lasted for 30 minutes . MEASUREMENTS AND FINDINGS women who took part in the prenatal yoga programme reported significantly fewer pregnancy discomforts than the control group ( 38.28 vs 43.26 , z=-2.58 , p=0.01 ) at 38 - 40 weeks of gestation . The subjects who participated in the yoga programme exhibited higher outcome and self-efficacy expectancies during the active stage of labour ( 104.13 vs 83.53 , t=3.24 , p=0.002 ; 99.26 vs 77.70 , t=3.99 , p ≤ 0.001 ) and the second stage of labour ( 113.33 vs 88.42 , t=3.33 , p=0.002 ; 102.19 vs 79.40 , t=3.71 , p ≤ 0.001 ) compared with the control group . KEY CONCLUSIONS the provision of booklets and videos on yoga during pregnancy may contribute to a reduction in pregnancy discomforts and improved childbirth self-efficacy . IMPLICATION S FOR PRACTICE this yoga programme provides health-care professionals with an evidence -based intervention Objective To evaluate the effect of an antenatal integrative medicine education programme in addition to usual care for nulliparous women on intrapartum epidural use . Design Open-label , assessor blind , r and omised controlled trial . Setting 2 public hospitals in Sydney , Australia . Population 176 nulliparous women with low-risk pregnancies , attending hospital-based antenatal clinics . Methods and intervention The Complementary Therapies for Labour and Birth protocol , based on the She Births and acupressure for labour and birth courses , incorporated 6 evidence -based complementary medicine techniques : acupressure , visualisation and relaxation , breathing , massage , yoga techniques , and facilitated partner support . R and omisation occurred at 24–36 weeks ’ gestation , and participants attended a 2-day antenatal education programme plus st and ard care , or st and ard care alone . Main outcome measures Rate of analgesic epidural use . Secondary : onset of labour , augmentation , mode of birth , newborn outcomes . Results There was a significant difference in epidural use between the 2 groups : study group ( 23.9 % ) st and ard care ( 68.7 % ; risk ratio ( RR ) 0.37 ( 95 % CI 0.25 to 0.55 ) , p≤0.001 ) . The study group participants reported a reduced rate of augmentation ( RR=0.54 ( 95 % CI 0.38 to 0.77 ) , p<0.0001 ) ; caesarean section ( RR=0.52 ( 95 % CI 0.31 to 0.87 ) , p=0.017 ) ; length of second stage ( mean difference=−0.32 ( 95 % CI −0.64 to 0.002 ) , p=0.05 ) ; any perineal trauma ( 0.88 ( 95 % CI 0.78 to 0.98 ) , p=0.02 ) and resuscitation of the newborn ( RR=0.47 ( 95 % CI 0.25 to 0.87 ) , p≤0.015 ) . There were no statistically significant differences found in spontaneous onset of labour , pethidine use , rate of postpartum haemorrhage , major perineal trauma ( third and fourth degree tears/episiotomy ) , or admission to special care nursery/neonatal intensive care unit ( p=0.25 ) . Conclusions The Complementary Therapies for Labour and Birth study protocol significantly reduced epidural use and caesarean section . This study provides evidence for integrative medicine as an effective adjunct to antenatal education , and contributes to the body of best practice evidence . Trial registration number ACTRN12611001126909 OBJECTIVES To examine the effectiveness of a birth ball exercise programme during childbirth by measuring childbirth self-efficacy and childbirth pain . In addition , it tested the mediating effects of childbirth self-efficacy on the relationship between the birth ball exercise programme and childbirth pain . DESIGN R and omised controlled trial . PARTICIPANTS AND SETTING The study was conducted from December 2008 to November 2009 , at two birth units , one at a regional hospital and one at a medical centre , with 600 and 1022 annual births , respectively . One hundred and eighty-eight expectant mothers were recruited ( recruitment rate : 47 % ) and were allocated by block r and omisation into the two arms of the study , but only 48 intervention and 39 control group participants completing the trial . INTERVENTIONS The birth ball exercise programme consisted of a 26-page booklet and a 19-minute videotape , with periodic follow-ups during prenatal checks . All members of the experimental group were asked
Output:
| There is no strong evidence that the effects were any different between groups for satisfaction in childbirth , or for caesarean section rate , need for assisted vaginal delivery or need for pharmacological pain relief .
There was insufficient evidence for the role of mindfulness and audio-analgesia .
The majority of trials did not report on the safety of the interventions . |
MS213188 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE To investigate the potential gain of the concomitant use of radiotherapy and chemotherapy in improving local control and reducing the need for colostomy , a r and omized phase III trial was performed in patients with locally advanced anal cancer . MATERIAL S AND METHODS From 1987 to 1994 , 110 patients were r and omized between radiotherapy alone and a combination of radiotherapy and chemotherapy . The patients had T3 - 4NO-3 or T1 - 2N1 - 3 anal cancer . Radiotherapy consisted of 45 Gy given in 5 weeks , with a daily dose of 1.8 Gy . After a rest period of 6 weeks , a boost of 20 or 15 Gy was given in case of partial or complete response , respectively . Surgical resection as part of the primary treatment was performed if possible in patients who had not responded 6 weeks after 45 Gy or with residual palpable disease after the completion of treatment . Chemotherapy was given during radiotherapy : 750 mg/m2 daily fluorouracil as a continuous infusion on days 1 to 5 and 29 to 33 , and a single dose of mitomycin 15 mg/m2 administered on day 1 . RESULTS The addition of chemotherapy to radiotherapy result ed in a significant increase in the complete remission rate from 54 % for radiotherapy alone to 80 % for radiotherapy and chemotherapy , and from 85 % to 96 % , respectively , if results are considered after surgical resections . This led to a significant improvement of locoregional control and colostomy-free interval ( P = .02 and P = .002 , respectively ) , both in favor of the combined modality treatment . The locoregional control rate improved by 18 % at 5 years , while the colostomy-free rate at that time increased by 32 % by the addition of chemotherapy to radiotherapy . No significant difference was found when severe side effects were considered , although anal ulcers were more frequently observed in the combined-treatment arm . The survival rate remained similar in both treatment arms . Skin ulceration , nodal involvement , and sex were the most important prognostic factors for both local control and survival . These remained significant after multivariate analysis . The improvement seen in local control by adding chemotherapy to radiotherapy also remained significant after adjusting for prognostic factors in the multivariate analysis . Event-free survival , defined as free of locoregional progression , no colostomy , and no severe side effects or death , showed significant improvement ( P = .03 ) in favor of the combined-treatment modality . The 5-year survival rate was 56 % for the whole patient group . CONCLUSION The concomitant use of radiotherapy and chemotherapy result ed in a significantly improved locoregional control rate and a reduction of the need for colostomy in patients with locally advanced anal cancer without a significant increase in late side effects Ifosfamide ( IFOS ) 5 g/m2 and its parent analog Cyclophosphamide ( CYCLO ) 1.5 g/m2 were studied in a r and omized phase II study , accruing 171 patients with advanced soft tissue sarcoma . Both drugs were administered as 24 hr infusions , every 3 weeks , with comcomitant Mesna 400 mg/m2 i.v . bolus 4 hourly X 9 doses . Twenty-four patients were ineligible and 12 were not evaluable . The groups were well matched for age , previous chemotherapy ( 42 % of the total ) or radiotherapy , the presence of distant metastases and performance status , but there were more females ( 59 % vs. 45 % ) in the IFOS arm . Among the 68 evaluable patients receiving IFOS , there were 2 CR , 10 PR ( overall response 18 % ) , 27 SD and 29 PD . For CYCLO , the corresponding results in 67 patients were 1 CR , 4 PR ( overall response 8 % ) , 23 SD and 39 PD . Using the chi-square test the P values for response rate and linear trend were 0.13 and 0.04 respectively . Response rates were higher for females ( 20 % vs. 5 % , P = 0.01 ) and patients who had not received previous chemotherapy ( 19 % vs. 4 % , P = 0.01 ) . Fourteen of the 17 responses came from a group of 43 females , who had not received previous chemotherapy , for whom the overall response rate was 37.5 % . Remissions were noted in only 4 histological subtypes ( central ly review ed material ) , i.e. , 5 of 17 synovial sarcomas , 7 of 13 mixed mesodermal sarcomas and 2 of 7 fibrosarcomas . One of the 31 leiomyosarcomas responded to Cyclophosphamide . Duration s of response did not differ significantly between the 2 arms -- median 26 , range 10 - 81 + weeks . Leucopenia was significantly more severe on CYCLO , particularly in patients who had received previous chemotherapy ( P = 0.007 ) . Serious infections occurred in approx . 7 % of patients with no difference between the two drugs , although there was one toxic death on CYCLO . Nausea and vomiting were significantly worse on IFOS and alopecia , related in extent to dose , was seen in both arms . Other side-effects , such as hematuria or rises in serum creatinine and encephalopathy , were infrequent and mild . A higher response rate with less myelosuppression suggests that IFOS may have advantages over CYCLO in combination therapy Introduction : Previous data suggest that women may live longer with advanced non-small cell lung cancer ( NSCLC ) than men . We evaluated whether sex affected survival in the Eastern Cooperative Oncology Group ( ECOG ) E1594 trial . E1594 r and omized patients with advanced NSCLC to one of four platinum doublets and found that all four regimens had comparable efficacy . Patients and Methods : Patients in the E1594 data base were divided into male and female cohorts ; response and survival were calculated separately for each cohort . Known prognostic factors and differences in toxicity profiles were compared between the two cohorts . Results : All 1157 eligible patients ( 431 women , 726 men ) from E1594 were included in this analysis . There was no statistically significant difference in performance status , weight loss of > 10 % , stage , or incidence of brain metastases between women and men . Response rates were similar ( 19 % for both ; P = 0.15 ) . The median survival time for women , however , was significantly longer at 9.2 months ( 95 % CI , 8.1–10.4 months ) versus only 7.3 months for men ( 95 % CI , 6.8–8.0 months ) ( P = 0.004 log-rank test ) . Toxicity was generally greater in women than in men . Conclusions : Women in ECOG 1594 had a 1.9-month statistically significant improvement in median survival compared with men , despite similar response rates and greater toxicity and no difference in other known prognostic factors . These data strongly support the significance of sex as a separate prognostic factor in advanced NSCLC and emphasize the importance of sex as a stratification factor in future phase III NSCLC trials UNLABELLED Currently , available chemotherapy regimens for patients with advanced or recurrent endometrial cancer are generally not curative . Thus , there is a need to identify more active single agents in this disease . In this study patients pre-treated and not pre-treated with first line combination chemotherapy were entered into a r and omized phase II study of either cyclophosphamide ( CYCLO ) or Ifosfamide ( IFOS ) . PATIENTS AND METHOD Sixty one eligible patients with recurrent or metastatic histologically proven , adenocarcinoma of the uterine corpus entered the study . The median age at entry was 62 ( range 40 - 74 ) years . Twenty patients ( 33 % ) had prior hormonal treatment and 31 ( 51 % ) prior chemotherapy . CYCLO was given at a dose of 1200 mg/m2 and IFOS at a dose of 5 g/m2 . Both drugs were administered i.v . over 24 hours on day one every three weeks . Adequate pre- and post hydration as well as use of Mesna in the Ifosfamide arm were m and atory . RESULTS A median of two treatment cycles ( range 1 - 12 ) per patient were given . In the chemotherapy-naive patients , in the CYCLO arm two PRs ( RR 14 % , C.I. 2 - 43 % ) were seen and in the IFOS arm two CRs , two PRs , ( RR 25 % , C.I. 7 - 52 % ) were observed . No responses were seen in pre-treated patients . The duration of responses were : 15 + , 7 + months for the CRs , 15 + and 5 months for PRs in IFOS arm and 67 + , 4 months in CYCLO arm . The hematological toxicity was dose-limiting and similar in both treatment arms . No serious non hematological toxicities were reported , but a transient increase of the creatinine blood level was seen in two IFOS patients ( 6 % ) . CONCLUSION Ifosfamide is an active drug in the treatment of chemotherapy-naive patients with advanced endometrial cancer and its application in currently used ( combination ) regimens should be considered BACKGROUND Based on the r and omised Euro-EWING99-R1 trial , vincristine , adriamycin , cyclophosphamide ( VAC ) may be able to replace vincristine , adriamycin , ifosfamide ( VAI ) in the treatment of st and ard-risk Ewing sarcoma . However some heterogeneity of treatment effect by gender was observed . The current exploratory study aim ed at investigating the influence of gender on treatment efficacy and acute toxicity . PATIENTS AND METHODS Impact of gender on event-free survival ( EFS ) , acute toxicity by course , switches between treatment arms and cumulative dose of alkylating agents was evaluated in multivariable models adjusted for age including terms to test for heterogeneity of treatment effect by gender . The analysis of the EFS was performed on the intention-to-treat population . RESULTS EFS did not significantly differ between the 509 males and 347 females ( p=0.33 ) , but an interaction in terms of efficacy was suspected between treatment and gender ( p=0.058 ) : VAC was associated with poorer EFS than VAI in males , hazard ratio ( HR ) (VAC/VAI)=1.37 [ 95 % confidence interval ( CI ) , 0.98 - 1.90 ] , contrasting with HR=0.81 [ 95%CI , 0.53 - 1.24 ] in females . Severe toxicity was more frequent in females , whatever the toxicity type . Thirty patients switched from VAI to VAC ( 9/251 males , 4 % , and 21/174 females , 12 % ) mostly due to renal toxicity , and three from VAC to VAI ( 2/258 males , 0.8 % , and 1/173 females , 0.6 % ) . A reduction of alkylating agent cumulative dose > 20 % was more frequent in females ( 15 % versus 9 % , p=0.005 ) , with no major difference between VAC and VAI ( 10 % versus 13 % , p=0.15 ) . CONCLUSION Differences of acute toxicity rate and cumulative doses of alkylating agents could not explain the marginal interaction observed in the Euro-EWING99-R1 trial data . Effects of gender-dependent polymorphism/activity of metabolic enzymes ( e.g. known for CYP2B6 ) of ifosfamide versus cyclophosphamide should be explored . External data are required to further evaluate whether there is heterogeneity of alkylating agent effect by gender . TRIAL NUMBERS NCT00987636 and EudraCT 2008 - 003658 - 13 BACKGROUND ALCL99 protocol including six courses of chemotherapy derived from the NHL-BFM protocol is widely used for the treatment of paediatric anaplastic large-cell lymphoma . In the ALCL99 trial , patients were r and omised to receive MTX 1 g/m² in 24 hr with intrathecal injection ( MTX1 ) versus MTX 3 g/m² in 3 hr without intrathecal ( MTX3 ) ; then to receive or not vinblastine ( high-risk patients ) . The present study provides information about the acute adverse reactions ( ARs ) during the six courses of the ALCL99 treatment , assesses risk factors for ARs and evaluates the risk of overweight related to treatment . METHODS Data concerning ARs were assessed using CTCv2 and analysed overall and according to the type of course . RESULTS Between 1999 and 2005 , 352 patients were recruited . Toxicity assessed after 2050 courses included grade 4 neutropaenia ( 70 % of courses ) , grade 3 - 4 stomatitis ( 13 % ) , grade 3 - 4 transaminase elevation ( 10 % ) and grade 3 - 4 infection ( 5 % ) . Four patients ( 1 % ) died of toxicity . The toxicity profile differed between courses-A ( significantly more haematological toxicity ) and courses-B ( significantly more stomatitis ) . The percentage of ARs was higher after the first course than after subsequent courses . Severe toxicity was more frequent after MTX1 than after MTX3 courses but did not differ between courses with or without vinblast
Output:
| Our meta- analysis did not confirm the hypothesis of a treatment-by-sex interaction on efficacy or toxicity outcomes |
MS213189 | ***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 optimal way of assessing the impact of pulmonary rehabilitation on functional status in chronic obstructive pulmonary disease ( COPD ) is currently unknown . The minimal clinical ly important difference for the constant work rate cycling exercise test also needs to be investigated to facilitate its interpretation . A study was undertaken to evaluate the changes in the 6-min walking test and in the constant work rate cycle endurance test immediately following and 1 year after pulmonary rehabilitation , together with the importance of these changes in terms of health status in patients with COPD . Methods : Patients with COPD of mean ( SD ) age 65 ( 8) years and mean ( SD ) forced expiratory volume in 1 s ( FEV1 ) 45 (15)% predicted were recruited from a multicentre prospect i ve cohort study and evaluated at baseline , immediately after a pulmonary rehabilitation programme ( n = 157 ) and at 1 year ( n = 106 ) . The 6-min walking test and the cycle endurance test were performed at each evaluation . Health status was evaluated with the St George Respiratory Question naire . Results : Following pulmonary rehabilitation , cycle endurance time increased ( 198 ( 352 ) s , p<0.001 ) and stayed over baseline values at 1 year ( p<0.001 ) . The 6-min walking distance also showed improvements following rehabilitation ( 25 ( 52 ) m , p<0.001 ) but returned to baseline values at the 1-year follow-up . Changes in cycle endurance time were more closely associated with changes in health status than with the 6-min walking test . An improvement of 100–200 s in the cycle endurance time was associated with clinical ly meaningful changes in the St George Respiratory Question naire scores . Conclusions : The cycle endurance test was more responsive than the 6-min walking test in detecting improvement in exercise tolerance following pulmonary rehabilitation , and was also better correlated with improvements in health status . An improvement in the cycle endurance time of 100–200 s appeared to be clinical ly meaningful Objective To evaluate an entirely outpatient-based program of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease COPD , using St . George ’s Respiratory question naire ( SGRQ ) , the 6-minutes walking test ( 6-MWT ) and BODE index as the primary outcome measures . Methods A prospect i ve , parallel-group controlled study of an outpatient rehabilitation program in 80 patients with COPD ( 67 men and 13 women ; mean age 64.8 ± 10.6 years ; FEV1 , 42.8 % ± 7.6 % of the predicted value . The active group ( n = 40 ) took part in a 14-week rehabilitation program [ 3 h/wk , 1.5 h of education and exercise and 1.5 h of cycling ] . The control group ( n = 40 ) was review ed routinely as medical out patients . The following evaluations were carried out at study entry and after14 weeks : ( 1 ) pulmonary function studies ; ( 2 ) 6-minutes walking test 6MWT ; ( 3 ) quality of life ; and ( 4 ) BODE index . Results The following patients completed the study : 35 patients ( 87.5 % ) from the active group ( mean age , 63.7 ± 11.9 years ; mean forced expiratory volume in one second ( FEV1 ) , 41.9 ± 2.6 % of the predicted value ) ; and 36 patients ( 88 % ) from the control group ( mean age , 65.9 ± 10.3 years ; mean FEV1 , 43.33 ± 3.6 % of the predicted value ) . We found no changes in pulmonary function parameters in the active group and the control one at 14weeks . On the other h and , there were significant changes within the components of the SGRQ ( 12.3 for the score total ) for the patients of the active group but not for the patients of the control one ( only 1.5 for the score total ) , we observed also a significant increase in the distance of the 6-MWT in the patients of the active group but not for the patients of the control one , and finally a decrease of two points ( from 6 to 4 ) was noted in the score of the active group ’s BODE index without any change in the control group ’s one . Conclusion An outpatient-based of 14-week rehabilitation program significantly improved the quality of life and exercise tolerance without any change in the pulmonary function in patients with moderate COPD , and there was also a large decrease in the risk of death in rehabilitated patients as measured using the BODE index Changes in health according to World Health Organization ’s International Classification of Functioning , Disability and Health ( ICF ) after four weeks of pulmonary rehabilitation ( PR ) were investigated . Gender differences in the response to PR , and the correlation between improvements in the two components of ICF ( Body functions and Activities and Participation ) were examined . Twenty-two men and 18 women with chronic obstructive pulmonary disease in Global Initiative for Chronic Obstructive Lung Disease ( GOLD ) stage II-IV attended in-patient , multidisciplinary PR consisting of endurance training four to five times/week at 70 % of peak work rate ( WRpeak ) , resistance training three to four times/week at 72 % of 15 repetitions maximum , educational sessions and individual counselling . The results were compared to those of 20 Chronic Obstructive Pulmonary Disease ( COPD ) patients included after the same criteria and investigated while waiting for admission to PR . In the rehabilitation group , we found significant improvements in health related quality of life ( HRQoL ) ( -7 units , St. George ’s Respiratory Question naire ) , arm ( 6 % ) and leg ( 15 % ) maximal voluntary contraction , peak oxygen uptake ( 6 % ) , WRpeak ( 60 % ) and treadmill endurance time ( 93 % ) . At iso-WR , ventilation and dyspnoea were significantly lower , but inspiratory capacity remained unchanged . Improvements in HRQoL correlated with increases in peak ventilation , but not in muscle strength or exercise capacity . Men improved their six-minute walking distance significantly in contrast to women . Clinical ly important improvements in HRQoL were found in two out of three of the men , and one out of three of the women . Four weeks of intensive PR generated significant health effects comparable to longer lasting programmes . Changes in exercise capacity and muscle strength were not related to improvements in HRQoL. The gender differences in the response to PR deserve attention in future studies BACKGROUND Current guidelines on pulmonary rehabilitation ( PR ) recommend upper extremity exercise training ( UEET ) in patients with COPD . However , the literature still questions the effectiveness of systematic UEET in this population . We studied the effects of 15 sessions of unsupported UEET on functional exercise capacity , the ability to perform activities of daily living ( ADL ) , and symptoms perceived during activities involving arms in patients with COPD . METHODS We conducted a r and omized trial that consisted of 3 weeks of inpatient PR , comparing the short-term effects of unsupported UEET plus PR ( intervention group ) to those of PR alone ( control group ) . A change in the 6-min ring test ( 6MRT ) was the primary outcome ; the ADL field test ( four shuttle stations ) , the dyspnea score as assessed by the Medical Research Council scale , the London Chest Activity of Daily Living scale ( LCADL ) , and the distance walked in 6 min served as secondary outcomes of the study . At the 6-month follow-up , we repeated the 6MRT and the LCADL . RESULTS Fifty patients with COPD were r and omly assigned to the two groups and completed the study . At the end of the study period , patients in the intervention group improved in the 6MRT and ADL field test compared with those patients in the control group ( p = 0.018 and p = 0.010 , respectively ) with reduced perception of fatigue ( p < or= 0.006 ) . At the 6-month follow-up , 6MRT ( p = 0.001 ) and LCADL ( p = 0.039 ) scores were still significantly better in the intervention group compared with the control group . CONCLUSIONS Our trial corroborates the effectiveness of unsupported UEET in specifically improving functional exercise capacity of patients with COPD . Moreover , it also provides evidence that this training modality may ameliorate and maintain the patients ' autonomy over and above st and ard PR . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00825032 Background Pulmonary rehabilitation is known to be a beneficial treatment for COPD patients . To date , however , there is no agreement for how long a rehabilitation program should be implemented . In addition , current views are that pulmonary rehabilitation does not improve FEV1 or even slow its decline in COPD patients . The aim of the study was to examine the efficacy of a 3 year outpatient pulmonary rehabilitation ( PR ) program for COPD patients on pulmonary function , exercise capability , and body mass index ( BMI ) . Methods A matched controlled trial was performed with outcome assessment s evaluated at 6 , 12 , 18 , 24 , 30 , and 36 months . Eighty patients with moderate to severe COPD ( age 63 ± 7 years ; FEV1 48 % ± 14 ) were recruited . The control group received st and ard care only , while in addition , the case study group received PR for duration of three years . These groups were matched for age , sex , BMI , FEV1 % and number of pack-years smoked . Results The decline in FEV1 after the three years was significantly lower in the PR group compared to control , 74 ml versus 149 ml , respectively ( p < 0.001 ) . Maximal sustained work and endurance time improved after a short period of PR and was maintained throughout the study , in contrast to the control group ( p < 0.01 ) . A decreased BMI was noted in the control group after three years , while in the PR group a mild improvement was seen ( p < 0.05 ) . Conclusion Three years of outpatient pulmonary rehabilitation result ed in modifying the disease progression of COPD , as well as improving physical performance in these patients BACKGROUND Inhaled hypertonic saline is used for bronchial challenge and sputum induction in patients with chronic obstructive pulmonary disease ( COPD ) . We studied the effects of saline aerosol inhalation before each exercise session in an 8-week pulmonary rehabilitation program . METHODS This was a double-blind r and omized parallel controlled trial , conducted at an out-patient clinic . Sixty-eight subjects with COPD ( mean age 67 + /- 6.5 y , percent of predicted FEV(1 ) 47 + /- 21 ) were r and omized to inhale either 3 % hypertonic saline ( 34 subjects ) or normal saline ( 34 subjects ) before each exercise session in an 8-week exercise program that had 3 sessions per week . We measured 6-min walk distance , dyspnea , and quality of life ( with the Medical Outcomes Study 36-item short-form health survey ) . RESULTS After the 8-week exercise program , both groups ' mean 6-min walk distance had significantly increased : from 195 + /- 92 m to 251 + /- 97 m ( P < .001 ) in the hypertonic-saline group , and from 237 + /- 93 m to 441 + /- 121 m in the normal-saline group ( P < .001 ) . The normal-saline group had greater improvement than the hypertonic-saline group ( P < .001 ) . Dyspnea score improved from 3.1 + /- 0.9 to 2.3 + /- 0.8 ( P < .01 ) in the hypertonic-saline group , and from 3.5 + /- 0.2 to 2.3 + /- 1.0 ( P < .01 ) in the normal-saline group . Quality of life also significantly improved , except for the physical-functioning and social aspect domains in the hypertonic-saline group . Adverse effects ( cough or bronchospasm ) occurred in 4 patients ( 12 % ) in the hypertonic-saline group . CONCLUSIONS The improvement in 6-min walk distance was greater with normal saline than with hypertonic saline . Hypertonic saline was associated with adverse effects . It is unclear whether the only predictor of improved functional exercise capacity was exercise training . ( Clinical Trials.gov number , NCT00639236 . ) OBJECTIVE To determine the safety and usefulness of a home-based pulmonary rehabilitation program for patients with very severe chronic obstructive pulmonary disease ( COPD ) who receive long-term treatment with oxygen . METHODS A r and omized prospect i ve study that included 50 patients with very severe COPD undergoing long-term treatment with oxygen . At the start of the program and after 12 months , the following evaluations were performed : pulmonary function tests , submaximal exercise capability , and quality of life . The rehabilitation program lasted for 1 year , with periodic home visits by a physiotherapist and included respiratory reeducation training of the respiratory muscles and muscular training . RESULTS Forty-two patients completed the study ( 27 in the rehabilitation group and 15 in the control group ) . There were no initial differences between the 2 groups . No complications arising from the performance of the exercises were observed . The rehabilitation group showed a clinical ly significant increase in the distance covered in the 6-minute walk test ( 313 ± 72 m vs 392 ± 82 m , P = .0001 ) and a clinical ly significant reduction in
Output:
| The st and ard rehabilitation programs showed positive effects on all of the outcomes evaluated , except for mortality ( because of the small number of analyses ) .
However , we found no differences among the various rehabilitation programs regarding their effects on the outcomes studied .
Rehabilitation programs can be considered important tools for the treatment of COPD . |
MS213190 | ***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 Patients with genotype 1 hepatitis C virus ( HCV ) who do not have a sustained response to therapy with peginterferon alfa and ribavirin have a low likelihood of success with retreatment . METHODS We r and omly assigned patients with HCV genotype 1 who had not had a sustained virologic response after peginterferon alfa-ribavirin therapy to one of four treatment groups : 115 patients to the T12PR24 group , receiving telaprevir ( 1125-mg loading dose , then 750 mg every 8 hours ) for 12 weeks and peginterferon alfa-2a ( 180 microg per week ) and ribavirin ( 1000 or 1200 mg per day , according to body weight ) for 24 weeks ; 113 patients to the T24PR48 group , receiving telaprevir for 24 weeks and peginterferon alfa-2a and ribavirin for 48 weeks ( at the same doses as in the T12PR24 group ) ; 111 patients to the T24P24 group , receiving telaprevir and peginterferon alfa-2a for 24 weeks ( at the same doses as in the T12PR24 group ) ; and 114 patients to the PR48 ( or control ) group , receiving peginterferon alfa-2a and ribavirin for 48 weeks ( at the same doses as in the T12PR24 group ) . The primary end point was sustained virologic response ( undetectable HCV RNA levels 24 weeks after the last dose of study drugs ) . RESULTS The rates of sustained virologic response in the three telaprevir groups--51 % in the T12PR24 group , 53 % in the T24PR48 group , and 24 % in the T24P24 group -- were significantly higher than the rate in the control group ( 14 % ; P<0.001 , P<0.001 , and P=0.02 , respectively ) . Response rates were higher among patients who had previously had relapses than among nonresponders . One of the most common adverse events in the telaprevir groups was rash ( overall , occurring in 51 % of patients , with severe rash in 5 % ) . Discontinuation of study drugs because of adverse events was more frequent in the telaprevir groups than in the control group ( 15 % vs. 4 % ) . CONCLUSIONS In HCV-infected patients in whom initial peginterferon alfa and ribavirin treatment failed , retreatment with telaprevir in combination with peginterferon alfa-2a and ribavirin was more effective than retreatment with peginterferon alfa-2a and ribavirin alone . ( Clinical Trials.gov number , NCT00420784 . A r and om-primed complementary DNA library was constructed from plasma containing the uncharacterized non-A , non-B hepatitis ( NANBH ) agent and screened with serum from a patient diagnosed with NANBH . A complementary DNA clone was isolated that was shown to encode an antigen associated specifically with NANBH infections . This clone is not derived from host DNA but from an RNA molecule present in NANBH infections that consists of at least 10,000 nucleotides and that is positive-str and ed with respect to the encoded NANBH antigen . These data indicate that this clone is derived from the genome of the NANBH agent and are consistent with the agent being similar to the togaviridae or flaviviridae . This molecular approach should be of great value in the isolation and characterization of other unidentified infectious agents BACKGROUND In patients with chronic infection with hepatitis C virus ( HCV ) genotype 1 , treatment with peginterferon alfa and ribavirin for 48 weeks results in rates of sustained virologic response of 40 to 50 % . Telaprevir is a specific inhibitor of the HCV serine protease and could be of value in HCV treatment . METHODS A total of 334 patients who had chronic infection with HCV genotype 1 and had not been treated previously were r and omly assigned to receive one of four treatments involving various combinations of telaprevir ( 1250 mg on day 1 , then 750 mg every 8 hours ) , peginterferon alfa-2a ( 180 microg weekly ) , and ribavirin ( dose according to body weight ) . The T12PR24 group ( 81 patients ) received telaprevir , peginterferon alfa-2a , and ribavirin for 12 weeks , followed by peginterferon alfa-2a and ribavirin for 12 more weeks . The T12PR12 group ( 82 patients ) received telaprevir , peginterferon alfa-2a , and ribavirin for 12 weeks . The T12P12 group ( 78 patients ) received telaprevir and peginterferon alfa-2a without ribavirin for 12 weeks . The PR48 ( control ) group ( 82 patients ) received peginterferon alfa-2a and ribavirin for 48 weeks . The primary end point , a sustained virologic response ( an undetectable HCV RNA level 24 weeks after the end of therapy ) , was compared between the control group and the combined T12P12 and T12PR12 groups . RESULTS The rate of sustained virologic response for the T12PR12 and T12P12 groups combined was 48 % ( 77 of 160 patients ) , as compared with 46 % ( 38 of 82 ) in the PR48 ( control ) group ( P=0.89 ) . The rate was 60 % ( 49 of 82 patients ) in the T12PR12 group ( P=0.12 for the comparison with the PR48 group ) , as compared with 36 % ( 28 of 78 patients ) in the T12P12 group ( P=0.003 ; P=0.20 for the comparison with the PR48 group ) . The rate was significantly higher in the T12PR24 group ( 69 % [ 56 of 81 patients ] ) than in the PR48 group ( P=0.004 ) . The adverse events with increased frequency in the telaprevir-based groups were pruritus , rash , and anemia . CONCLUSIONS In this phase 2 study of patients infected with HCV genotype 1 who had not been treated previously , one of the three telaprevir groups had a significantly higher rate of sustained virologic response than that with st and ard therapy . Response rates were lowest with the regimen that did not include ribavirin . ( Clinical Trials.gov number , NCT00372385 . IMPORTANCE The efficacy of directly acting antiviral agents in interferon-free regimens for the treatment of chronic hepatitis C infections needs to be evaluated in different population s. OBJECTIVE To determine the efficacy and safety of sofosbuvir with weight-based or low-dose ribavirin among a population with unfavorable treatment characteristics . DESIGN , SETTING , AND PATIENTS Single-center , r and omized , 2-part , open-label phase 2 study involving 60 treatment-naive patients with hepatitis C virus ( HCV ) genotype 1 enrolled at the National Institutes of Health ( October 2011-April 2012 ) . INTERVENTIONS In the study 's first part , 10 participants with early to moderate liver fibrosis were treated with 400 mg/d of sofosbuvir and weight-based ribavirin for 24 weeks . In the second part , 50 participants with all stages of liver fibrosis were r and omized 1:1 to receive 400 mg of sofosbuvir with either weight-based or low-dose 600 mg/d of ribavirin for 24 weeks . MAIN OUTCOMES AND MEASURES The primary study end point was the proportion of participants with undetectable HCV viral load 24 weeks after treatment completion ( sustained virologic response of 24 weeks [ SVR24 ] ) . RESULTS In the first part of the study , 9 participants ( 90 % ; 95 % CI , 55%-100 % ) achieved SVR24 . In the second part , 7 participants ( 28 % ) in the weight-based group and 10 ( 40 % ) in the low-dose group relapsed after treatment completion leading to SVR24 rates of 68 % ( 95 % CI , 46%-85 % ) in the weight-based group and 48 % ( 95 % CI , 28%-69 % ; P = .20 ) in the low-dose group . Twenty individuals participated in a pharmacokinetic-viral kinetic sub study , which demonstrated a slower loss rate of infectious virus in relapsers than in participants who achieved SVR ( clearance , 3.57/d vs 5.60/d ; P = .009 ) . The most frequent adverse events were headache , anemia , fatigue , and nausea . There were 7 grade 3 events including anemia , neutropenia , nausea , hypophosphatemia , and cholelithiasis or pancreatitis . No one discontinued treatment due to adverse events . CONCLUSION AND RELEVANCE In a population of patients with a high prevalence of unfavorable traditional predictors of treatment response , a 24-week regimen of sofosbuvir and weight-based or low-dose ribavirin result ed in SVR24 rates of 68 % and 48 % , respectively . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01441180 BACKGROUND Protease inhibitors have improved treatment of infection with hepatitis C virus ( HCV ) , but dosing , a low barrier to resistance , drug interactions , and side-effects restrict their use . We assessed the safety and efficacy of sofosbuvir , a uridine nucleotide analogue , in treatment-naive patients with genotype 1 - 3 HCV infection . METHODS In this two-cohort , phase 2 trial , we recruited treatment-naive patients with HCV genotypes 1 - 3 from 22 centres in the USA . All patients were recruited between Aug 16 , 2010 , and Dec 13 , 2010 , and were eligible for inclusion if they were aged 18 - 70 years , had an HCV RNA concentration of 50,000 IU/mL or greater , and had no cirrhosis . We r and omly allocated all eligible patients with HCV genotype 1 ( cohort A ) to receive sofosbuvir 200 mg , sofosbuvir 400 mg , or placebo ( 2:2:1 ) for 12 weeks in combination with peginterferon ( 180 μg per week ) and ribavirin ( 1000 - 1200 mg daily ) , after which they continued peginterferon and ribavirin for an additional 12 weeks or 36 weeks ( depending on viral response ) . R and omisation was done by use of a computer-generated r and omisation sequence and patients and investigators were masked to treatment allocation until week 12 . Patients with genotypes 2 or 3 ( cohort B ) received open-label sofosbuvir 400 mg plus peginterferon and ribavirin for 12 weeks . Our primary outcomes were safety and tolerability . Secondary efficacy analyses were by intention to treat and endpoints included sustained virological response , defined as undetectable HCV RNA at post-treatment weeks 12 and 24 . This study is registered with Clinical Trials.gov , number NCT01188772 . FINDINGS In cohort A , 122 patients were assigned 200 mg sofosbuvir ( 48 patients ) , 400 mg sofosbuvir ( 48 ) , or placebo ( 26 ) . We enrolled 25 patients into cohort B. The most common adverse events -- fatigue , headache , nausea , and chills -- were consistent with those associated with peginterferon and ribavirin . Eight patients discontinued treatment due to adverse events , two ( 4 % ) receiving sofosbuvir 200 mg , three ( 6 % ) receiving sofosbuvir 400 mg , and three ( 12 % ) receiving placebo . In cohort A , HCV RNA was undetectable at post-treatment week 12 in 43 ( 90 % ; 95 % CI 77 - 97 ) of 48 patients in the 200 mg sofosbuvir group ; 43 ( 91 % ; 80 - 98 ) of 47 patients in the 400 mg sofosbuvir group , and 15 ( 58 % ; 37 - 77 ) of 26 patients in the placebo group . In cohort B , 23 ( 92 % ) of 25 patients had undetectable HCV RNA at post-treatment week 12 . INTERPRETATION Our findings lend support to the further assessment , in phase 2 and 3 trials , of sofosbuvir 400 mg plus peginterferon and ribavirin for 12 weeks in treatment-naive patients with HCV genotype-1 . FUNDING Gilead Sciences All-oral combinations of direct-acting antivirals may improve efficacy and safety outcomes for patients with hepatitis C virus ( HCV ) infection , particularly those who are poor c
Output:
| Simeprevir + pegylated interferon + ribavirin is an alternative for patients with HCV genotype 1 ( SVR , 79%-86 % ) .
AND RELEVANCE New , short- duration , simpler therapies result in high SVR rates for HCV-infected patients .
In conjunction with increased screening for HCV as suggested by recent Centers for Disease Control and Prevention guidelines , availability of new therapies may lead to the treatment of many more people with chronic HCV infection |
MS213191 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: PURPOSE Primary care physicians ( PCPs ) constitute an appropriate target for new interventions and educational campaigns design ed to increase skin cancer screening and prevention . The aim of this r and omized study was to determine whether the adjunct of dermoscopy to the st and ard clinical examination improves the accuracy of PCPs to triage lesions suggestive of skin cancer . PATIENTS AND METHODS PCPs in Barcelona , Spain , and Naples , Italy , were given a 1-day training course in skin cancer detection and dermoscopic evaluation , and were r and omly assigned to the dermoscopy evaluation arm or naked-eye evaluation arm . During a 16-month period , 73 physicians evaluated 2,522 patients with skin lesions who attended their clinics and scored individual lesions as benign or suggestive of skin cancer . All patients were re-evaluated by expert dermatologists at clinics for pigmented lesions . Referral accuracy of both PCP groups was calculated by their scores , which were compared to those tabulated for dermatologists . RESULTS Referral sensitivity , specificity , and positive and negative predictive values were 54.1 % , 71.3 % , 11.3 % , and 95.8 % , respectively , in the naked-eye arm , and 79.2 % , 71.8 % , 16.1 % , and 98.1 % , respectively , in the dermoscopy arm . Significant differences were found in terms of sensitivity and negative predictive value ( P = .002 and P = .004 , respectively ) . Histopathologic examination of equivocal lesions revealed 23 malignant skin tumors missed by PCPs performing naked-eye observation and only six by PCPs using dermoscopy ( P = .002 ) . CONCLUSION The use of dermoscopy improves the ability of PCPs to triage lesions suggestive of skin cancer without increasing the number of unnecessary expert consultations Background Few patients with lower bowel symptoms who consult their general practitioner need a specialist opinion . However data from referred patients suggest that those who are referred would benefit from detailed assessment before referral . Methods A cluster r and omised factorial trial . 44 general practice s in North Trent , UK . Practice s were offered either an electronic interactive referral pro forma , an educational outreach visit by a local colorectal surgeon , both or neither . The main outcome measure was the proportion of cases with severe diverticular disease , cancer or precancerous lesions and inflammatory bowel disease in those referred by each group . A secondary outcome was a referral letter quality score . Semi-structured interviews were conducted to identify key themes relating to the use of the software Results From 150 invitations , 44 practice s were recruited with a total list size of 265,707 . There were 716 consecutive referrals recorded over a six-month period , for which a diagnosis was available for 514 . In the combined software arms 14 % ( 37/261 ) had significant pathology , compared with 19 % ( 49/253 ) in the non-software arms , relative risk 0.73 ( 95 % CI : 0.46 to 1.15 ) . In the combined educational outreach arms 15 % ( 38/258 ) had significant pathology compared with 19 % ( 48/256 ) in the non-educational arms , relative risk 0.79 ( 95 % CI : 0.50 to 1.24 ) . Pro forma practice s documented better assessment of patients at referral . Conclusion There was a lack of evidence that either intervention increased the proportion of patients with organic pathology among those referred . The interactive software did improve the amount of information relayed in referral letters although we were unable to confirm if this made a significant difference to patients or their health care providers . The potential value of either intervention may have been diminished by their limited uptake within the context of a cluster r and omised clinical trial . A number of lessons were learned in this trial of novel innovations OBJECTIVE To investigate whether the observational skills of doctors and nurses can be improved by arts-based observational skills training . METHODS We carried out a cluster design , controlled trial involving 42 general practitioners and 26 primary care nurses in 12 primary care practice s in London . Six practice s were allocated to the intervention arm and 6 to the control arm . The intervention group received 90 minutes of arts-based observational skills training . The control group received practical training in the management of psoriasis . Before and after this , control and intervention participants were asked to describe 3 dermatological photographs . Descriptions were scored blindly against a predetermined marking key . Participants completed a question naire about the intervention , and about their own confidence in diagnosing and referring suspicious pigmented skin lesions . RESULTS Post-intervention scores were significantly higher in the intervention group compared with the control group ( P < 0.001 ) . The majority of participants judged the intervention relevant , enjoyable and valuable . A majority lacked confidence in their dermatological knowledge and skills . DISCUSSION This study provides statistically significant evidence that arts-based observational skills training can improve the observational skills of doctors and nurses . It is important not to overstate the clinical significance of these findings , and to recognise that observational skills are just one of many complex and subtle factors affecting the quality of the clinical process . Further research is needed to assess the existence , nature and clinical significance of longer-term benefits , and to identify differences between professional groups Objectives To evaluate the effects of a brief educational program on beliefs , knowledge , and behaviors related to skin cancer control among internal medicine housestaff and attending physicians . Design R and omized controlled trial . Setting Urban academic general medicine practice . Participants Internal medicine housestaff and attending physicians with continuity clinics at the practice site . InterventionTwo 1-hour educational seminars on skin cancer control conducted jointly by a general internist and a dermatologist . Measurements and main results Self-reported attitudes and beliefs about skin cancer control , ability to identify and make treatment decisions on 18 skin lesions , and knowledge of skin cancer risk factors were measured by a question naire before and after the teaching intervention . Exit surveys of patients at moderate to high risk of skin cancer were conducted 1 month before and 1 month after the intervention to measure physician skin cancer control practice s reported by patients . Eighty-two physicians completed baseline question naires and were enrolled in the study , 46 in the intervention group and 36 in the control group . Twenty-five physicians attended both sessions , 11 attended one , and 10 attended neither . Postintervention , the percentage of physicians feeling adequately trained increased from 35 % to 47 % in the control group ( p=.34 ) and from 37 % to 57 % in the intervention group ( p=.06 ) . Intervention physicians had an absolute mean improvement in their risk factor identification score of 6.7 % , while control physicians ' mean score was unchanged ( p=.06 ) . Intervention and control physicians had similar increases in their postintervention lesion identification and managment scores . Postintervention , the mean proportion of patients per physician stating they were advised to watch their moles increased more among intervention physicians than control physicians ( absolute difference of 19 % vs −8%,p=.04 ) . Other changes in behavior were not significant . Conclusions Although we observed a few modest intervention effects , overall this brief skin cancer education intervention did not significantly affect primary care physicians ’ skin cancer control attitudes , beliefs , knowledge , or behaviors . A more intensive intervention with greater participation may be necessary to show a stronger impact on attitudes and knowledge about skin cancer control among primary care physicians OBJECTIVE To determine whether a distance-learning programme on LUTS provided to the general practitioner affected patient self-management . METHODS A r and omised trial was performed to examine the effects of the distance-learning programme ( an educational package for the GP and a patient information leaflet ) compared with written guidelines on LUTS mailed to the GP . In 63 general practice s ( 32 intervention and 31 control ) across the Netherl and s all patients older than 50 years presenting LUTS for the first time were invited to participate . Main outcome measures were patient evaluation of quality of care received and perceptions of enablement . RESULTS A total of 151 patients was included . The intervention increased patient enablement regarding maintenance of independence ( OR = 3.14 ) and coping with illness ( OR = 2.21 ) . Overall enablement scores were not changed . Patients in the intervention group had more positive evaluations of general practice care received ( OR = 2.28 to 3.95 ) . An explorative analysis suggested that the effects of the intervention were mediated in particular by h and ing out of patient information leaflets . CONCLUSIONS A distance-learning programme on LUTS for general practitioners had positive effects on patient self-management . H and ing out leaflets appeared to be a crucial mediating factor Background : Iron deficiency anaemia ( IDA ) remains the most common cause of anaemia and is frequently secondary to occult gastrointestinal blood loss requiring further investigation . The study was design ed to prospect ively assess the adequacy of investigation of IDA and to establish whether a simple computerised prompt would increase the completeness of investigation of patients presenting to their general practitioners . Patients and methods : All men aged > 20 and women aged > 50 newly found to have a probable IDA ( n=431 ) in primary care were r and omised according to general practice ( n=89 ) to one of two computer generated prompts , by the haematology laboratories in two large district general hospitals . Data were collected 12 months after the index date . The primary outcome measure was the adequacy of investigation of the cause of anaemia . Multiple logistic regression was used to analyse each binary outcome . Results : Two hundred and three ( 47 % ) of 431 patients presenting to their general practitioner with an IDA were adequately managed and 140/357 ( 39 % ) of patients who were otherwise fit for investigation had no tests at all . Twenty one ( 17 % ) of 125 patients who did have adequate investigation at the time of presentation were found to have colorectal cancer . Only 30 % of patients had a confirmed diagnosis within 12 months . The prompt did not affect the level of investigation ( odds ratio 0.88 , 95 % confidence interval ( CI ) 0.60 to 1.29 , p=0.52 ) . The initial prescribing of oral iron was improved ( odds ratio 2.19 , 95 % CI 1.27 to 3.77 , p=0.005 ) , but not the documented prescribing of a full therapeutic course or the use of follow up blood counts . Conclusions : The investigation and management of IDA presenting in general practice remains inadequate and is not improved by a simple management prompt Background Skin surface microscopy ( oil epiluminescence microscopy , dermoscopy , dermatoscopy ) has been shown to increase the diagnostic accuracy of melanoma . However , all studies to date have been in an expert setting The purpose of this study was to determine whether a targeted intervention could improve primary care practitioners ' concordance with guidelines regarding management of women with breast symptoms . One hundred and twelve practitioners from r and omly selected areas around Australia prospect ively audited their investigations for each woman with a new breast symptom over two 12-week periods , before and five months after the release of national guidelines . Between the two audits , doctors received feedback on practice in relation to peers and attended one seminar in their local areas led by specialists from the Royal Australasian College of Physicians and the Royal Australasian College of Surgeons . For five recommendations , there were statistically significant improvements at the second audit in line with st and ard Investigation of a New Breast Symptom ( INBS ) guidelines . All these were for investigations of breast lumps . At first audit , there were seven recommendations where practitioners were already managing more than 80 % of women in accordance with the INBS , and where there were no statistically significant increases in concordance at second audit . Another six recommendations had lower concordance with the recommendations prior to the release of the guidelines and did not significantly improve at second audit . These tended to be for less-common presentations and where clinical findings were not consistent with other test results . We concluded that a targeted intervention improved physician concordance with current best advice for investigating women who present with new breast symptoms in a primary care setting . Further educational programs are needed to improve investigations for rarer symptoms , and to enhance physicians ' confidence in the results of their clinical examinations OBJECTIVE To determine the efficacy of an Internet-based skin cancer triage intervention for physicians . METHODS Physicians were r and omly assigned to an intervention group or a control group . The 14 outcome measures included diagnosis and evaluation planning for malignant melanoma , basal cell carcinoma , and squamous cell carcinoma . RESULTS Forty-six physicians ( 27 of 39 in the intervention group ) completed the program . The intervention group scored significantly higher than did the control group in nine of 14 outcome measures ; this improvement was maintained for five of the nine outcomes . CONCLUSION The Internet intervention improved physicians ' skin cancer diagnosis and evaluation planning test performances Background : Family physicians have an important clinical role in assessment and management of suspicious skin lesions . As a result of a previous needs assessment study , an educational intervention based on audit and feedback with opportunity for reflection on practice was introduced to 46 family physicians r and omly allocated to either an intervention ( 23 ) or control group ( 23 ) . As an educational tool , audit allows doctors to systematic ally review their practice and establish the quality of care they provide . When combined with feedback and comparison of clinical performance with peers or st and ards , it has been shown to increase learning and change behavior . Methods : Data based on their own patients , on the correlation between clinical and histologic diagnosis , and excisions of skin lesions were collated and reported to the intervention group . Results : Despite r and omization of the doctors , the patient population of doctors in the intervention and control groups were significantly different in key characteristics , including the types of skin lesions treated . The intervention group of doctors showed improved performance in providing clinical information on pathology requests and
Output:
| Most studies reported a positive effect on their specified outcomes , although no study measured a direct effect on reducing delay .
CONCLUSION There was no evidence that any intervention directly reduced primary care delay in the diagnosis of cancer .
Limited evidence suggests that complex interventions , including audit and feedback and specific skills training , have the potential to do so |
MS213192 | ***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 Although tests for occult blood in the feces are widely used to screen for colorectal cancers , there is no conclusive evidence that they reduce mortality from this cause . We evaluated a fecal occult-blood test in a r and omized trial and documented its effectiveness . METHODS We r and omly assigned 46,551 participants 50 to 80 years of age to screening for colorectal cancer once a year , to screening every two years , or to a control group . Participants who were screened su bmi tted six guaiac-impregnated paper slides with two smears from each of three consecutive stools . About 83 percent of the slides were rehydrated . Participants who tested positive underwent a diagnostic evaluation that included colonoscopy . Vital status was ascertained for all study participants during 13 years of follow-up . A committee determined causes of death . A single pathologist determined the stage of each tissue specimen . Differences in mortality from colorectal cancer , the primary study end point , were monitored with the sequential log-rank statistic . RESULTS The 13-year cumulative mortality per 1000 from colorectal cancer was 5.88 in the annually screened group ( 95 percent confidence interval , 4.61 to 7.15 ) , 8.33 in the biennially screened group ( 95 percent confidence interval , 6.82 to 9.84 ) , and 8.83 in the control group ( 95 percent confidence interval , 7.26 to 10.40 ) . The rate in the annually screened group , but not in the biennially screened group , was significantly lower than that in the control group . Reduced mortality in the annually screened group was accompanied by improved survival in those with colorectal cancer and a shift to detection at an earlier stage of cancer . CONCLUSIONS Annual fecal occult-blood testing with rehydration of the sample s decreased the 13-year cumulative mortality from colorectal cancer by 33 percent BACKGROUND Flexible sigmoidoscopy ( FS ) has been recommended as a screening method to reduce mortality from colorectal cancer ( CRC ) . The present study evaluates the effect of adding FS to the fecal occult blood test Hemoccult-II ( H-II ) on diagnostic yield of colorectal neoplasia . METHODS A total of 10,978 normal persons aged 50 - 75 years were invited to participate , 5495 persons being allocated at r and om to H-II and FS and 5483 to H-II alone . RESULTS In spite of a lower compliance ( 40 % versus 56 % ) for the combined procedure , the diagnostic yield of colorectal neoplasia was higher than for H-II alone ( 12 CRC versus 4 CRC , and 72 large adenomas versus 14 ) . Within 24 - 62 months after screening there were fewer CRCs detected after H-II + FS than after H-II alone . The stage distribution was less favorable than in screen-detected cases . CONCLUSION One FS may not be an optimal way of screening , but FS deserves to be evaluated in r and omized population studies including repeated H-II tests in the control arm Data are presented on the sensitivity , specificity , and positive predictivity of the Hemoccult test based on the experience of the Minnesota Colon Cancer Control Study , a r and omized clinical trial to determine whether the use of the Hemoccult test can reduce mortality from colorectal cancer . Rehydrating the slides with a drop of water before processing result ed in an increase in positivity ( 2.4 % to 9.8 % ) , and sensitivity ( 80.8 % to 92.2 % ) but a decrease in specificity ( 97.7 % to 90.4 % ) and positive predictivity ( 5.6 % to 2.2 % ) . The effects of age and sex were also evaluated . The test was less specific for men than women ( p = 0.03 ) . Specificity was highest for those less than 60 yr of age and decreased with increasing age ( p = 0.05 ) . The positive predictivity increased with age from 1.6 % for those under 60 yr to 3.6 % for those over 70 yr ( p = 0.0004 ) BACKGROUND Fecal occult-blood testing and sigmoidoscopy have been recommended for screening for colorectal cancer , but the sensitivity of such combined testing for detecting neoplasia is uncertain . At 13 Veterans Affairs medical centers , we performed colonoscopy to determine the prevalence of neoplasia and the sensitivity of one-time screening with a fecal occult-blood test plus sigmoidoscopy . METHODS Asymptomatic subjects ( age range , 50 to 75 years ) provided stool specimens on cards from three consecutive days for fecal occult-blood testing , which were rehydrated for interpretation . They then underwent colonoscopy . Sigmoidoscopy was defined in this study as examination of the rectum and sigmoid colon during colonoscopy , and sensitivity was estimated by determining how many patients with advanced neoplasia had an adenoma in the rectum or sigmoid colon . Advanced colonic neoplasia was defined as an adenoma 10 mm or more in diameter , a villous adenoma , an adenoma with high- grade dysplasia , or invasive cancer . Classification of subjects according to the findings was based on the most advanced lesion . RESULTS A total of 2885 subjects returned the three specimen cards for fecal occult-blood testing and underwent a complete colonoscopic examination . A total of 23.9 percent of subjects with advanced neoplasia had a positive test for fecal occult blood . As compared with subjects who had a negative test for fecal occult blood , the relative risk of advanced neoplasia in subjects who had a positive test was 3.47 ( 95 percent confidence interval , 2.76 to 4.35 ) . Sigmoidoscopy identified 70.3 percent of all subjects with advanced neoplasia . Combined one-time screening with a fecal occult-blood test and sigmoidoscopy identified 75.8 percent of subjects with advanced neoplasia . CONCLUSIONS One-time screening with both a fecal occult-blood test with rehydration and sigmoidoscopy fails to detect advanced colonic neoplasia in 24 percent of subjects with the condition BACKGROUND There is growing evidence that faecal-occult-blood ( FOB ) screening may reduce colorectal cancer ( CRC ) mortality , but this reduction in CRC mortality has not been shown in an unselected population -based r and omised controlled trial . The aim of this study was to assess the effect of FOB screening on CRC mortality in such a setting . METHODS Between February , 1981 , and January , 1991 , 152,850 people aged 45 - 74 years who lived in the Nottingham area of the UK were recruited to our study . Participants were r and omly allocated FOB screening ( 76,466 ) or no screening ( controls ; 76,384 ) . Controls were not told about the study and received no intervention . Screening-group participants were sent a Haemoccult FOB test kit with instructions from their family doctor . FOB tests were not rehydrated and dietary restrictions were imposed only for retesting borderline results . Individuals with negative FOB tests at the first screening , together with those who tested positive but in whom no neoplasia was found on colonoscopy , were invited to take part in further screening every 2 years . Screening was stopped in February , 1995 , by which time screening-group participants had been offered FOB tests between three and six times . Screening-group participants who had a positive test were offered full colonoscopy . All participants were followed up until June , 1995 . The primary outcome measure was CRC mortality . FINDINGS Of the 152,850 individuals recruited to the study , 2599 could not be traced or had emigrated and were excluded from the analysis . Thus , there were 75,253 participants in the screening group and 74,998 controls . 44,838 ( 59.6 % ) screening-group participants completed at least one screening . 28,720 ( 38.2 % ) of these individuals completed all the FOB tests they were offered and 16,118 ( 21.4 % ) completed at least one screening but not all the tests they were offered . 30,415 ( 40.4 % ) did not complete any test . Of 893 cancers ( 20 % stage A ) diagnosed in screening-group participants ( CRC incidence of 1.49 per 1000 person-years ) , 236 ( 26.4 % ) were detected by FOB screening , 249 ( 27.9 % ) presented after a negative FOB test or investigation , and 400 ( 44.8 % ) presented in non-responders . The incidence of cancer in the control group ( 856 cases , 11 % stage A ) was 1.44 per 1000 person-years . Median follow-up was 7.8 years ( range 4.5 - 14.5 ) . 360 people died from CRC in the screening group compared with 420 in the control group-a 15 % reduction in cumulative CRC mortality in the screening group ( odds ratio=0.85 [ 95 % ; CI 0.74 - 0.98 ] , p = 0.026 ) . INTERPRETATION Our findings together with evidence from other trials suggest that consideration should be given to a national programme of FOB screening to reduce CRC mortality in the general population Colorectal cancer ( CRC ) is a major health concern and a leading cause of cancer death in the Western world . The estimated lifetime risk of CRC is 5 % to 6 % , the incidence rate increases sharply after the age of 50 . Approximately 75 % of new cases occur in individuals at average risk [ 1 , 2 ] . Worldwide , it is estimated that there will be over one million new CRC cases in the year 2001 ( personal communication ) , and the annual ageadjusted incidence rate is 57 per 100 000 . Survival is directly related to the extent of disease at the time of diagnosis . Those diagnosed at an advanced stage have an estimated 5-year survival rate of 7 % , in contrast with a survival rate of 92 % for individuals detected at an early stage , since advanced CRC is largely refractory to conventional therapy and is one of the least curable malignancies [ 3 ] . Despite continuing advances in diagnosis and therapy , long-term survival has not improved significantly over the last four decades , and almost 50 % of CRC patients will eventually die of their disease [ 1 , 2 ] . This situation m and ates improvement in the early detection of this surgically curable disease and preventative interventions to reduce the incidence of the disease and its downstream morbidities and mortality . Indeed , given our underst and ing of the pathogenesis of CRC , current screening technologies , and effective preventative interventions , CRC should be highly preventable . Colorectal cancer has become an important issue for physicians and the general population in the last decade , ever since preventative medicine became a key issue in health care . Indeed , CRC is preventable in up to 90 % of cases [ 4 , 5 ] . CRC fulfils the criteria a disease must have for mass screening . Indeed , intestinal tumorigenesis is exceptionally suited for screening , since the adenoma – carcinoma sequence allows the detection and removal of pre-malignant lesions , and it is well established that patients who are maintained free of adenomas by endoscopic polypectomy are generally kept cancer free [ 4 , 6 , 7 ] . A study using Markov chain analysis has found that CRC decreases the life expectancy calculated for the entire US population by 292 days at age 50–54 years and by 70 days at age 70–74 years [ 8 ] . At the same time , an important controversial issue is the optimal screening approach for the averagerisk population at the age of 50 years . Endoscopic screening is undoubtedly the most effective screening method , but its potential disadvantages , such as invasiveness and cost , should be considered . The simplest and most evaluated screening method available for CRC is the fecal occult blood test ( FOBT ) . This periodic stool testing is considered a lowpriced , non-invasive test that requires no cathartic preparation . It can be performed on mailed specimens without a health center visit , and may reflect the full length of the colon . On the other h and , it is a less sensitive method , since many cancers and the large majority of pre-malignant adenomas do not bleed and are therefore missed . Furthermore , high falsepositive rates , due to dietary peroxidases and meat , or frequent and trivial sources of occult bleeding , lead to unnecessary colonoscopies that drive up programmatic costs . The first national screening program with FOBT was introduced in 1977 in Germany . The evaluation of this program was limited because of confidentiality problems . Case – control studies have yielded conflicting results regarding the effectiveness of FOBT as a screening modality [ 9 ] . The rationale for the use of FOBT screening programs is based on three major long-term r and omized trials . Overall , those trials using annual FOBT have reported a 15 % to 33 % reduction in CRC related death ( for review , see reference 10 ) . The Minnesota prospect i ve case – controlled study [ 11 ] is the study that is most cited . It included 46 000 subjects and showed a reduction in CRC mortality , after 13–18 years of follow-up , of 33 % for annual FOBT examination . Biennial testing result
Output:
| Diagnostic case – control studies generally reported higher sensitivities .
Conclusions Immudia HemSp appeared to be the most accurate immunochemical FOBT , however , there was no clear evidence to suggest whether guaiac or immunochemical FOBTs performed better , either from direct or indirect comparisons . |
MS213193 | ***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 Desmopressin-induced release of tissue plasminogen activator from endothelial cells may explain the absence of its hemostatic effect in patients undergoing cardiac surgery . Prior administration of the antifibrinolytic drug tranexamic acid might unmask such an effect , and combination therapy might thereby improve postoperative hemostasis . Methods and Results A double-blinded design r and omly allocated 163 adult patients undergoing coronary revascularization , valve replacement , both procedures , or repair of atrial septal defect to four treatment groups : placebo , tranexamic acid given as 10 mg/kg over 30 minutes followed by 1 mg . kg−1 . hr−1 for 12 hours initiated before skin incision , desmopressin given as 0.3 μg/kg over 20 minutes after protamine infusion , and both drugs . One surgeon performed all operations . Blood loss consisted of mediastinal tube drainage over 12 hours . Follow-up visits sought evidence of myocardial infa rct ion and stroke . Desmopressin decreased neither the 12-hour blood loss nor the amount of homologous red cells transfused . Tranexamic acid alone significantly reduced 12-hour blood loss , by 30%1 ( mean , 318 versus 453 ml ; Conclusions Desmopressin exerts no hemostatic effect , with or without prior administration of antifibrinolytic drug . Prophylactic tranexamic acid alone appears economical and safe in decreasing blood loss and transfusion requirement after cardiac surgery Intraoperatively administered , tranexamic acid ( TA ) does not reduce bleeding in total hip replacement ( THR ) . Therefore , its prophylactic use was attempted in the present study because this has been shown to be more effective in cardiac surgery . We investigated 40 patients undergoing THR in a prospect i ve , r and omized , double-blinded study . Twenty patients received TA given in two bolus doses of 10 mg/kg each , the first just before surgical incision and the second 3 h later . In addition , a continuous infusion of TA , 1.0 mg · kg−1 · h−1 for 10 h , was given after the first bolus dose . The remaining 20 patients formed a control group . Both groups used preoperative autologous blood donation and intraoperative autotransfusion . Intraoperative bleeding was significantly less ( P = 0.001 ) in the TA group compared with the control group ( 630 ± 220 mL vs 850 ± 260 mL ) . Postoperative drainage bleeding was correspondingly less ( P = 0.001 ) ( 520 ± 280 vs 920 ± 410 mL ) . Up to 10 h postoperatively , plasma D-dimer concentration was halved in the TA group compared with the control group . One patient in each group had an ultrasound-verified late deep vein thrombosis . In conclusion , we found TA , administrated before surgical incision , to be efficient in reducing bleeding during THR . Implication s In a prospect i ve , double-blinded study of 40 patients undergoing total hip replacement , the preoperative administration of tranexamic acid reduced bleeding by 35 % , probably by decreasing induced fibrinolysis . Whether tranexamic acid therapy can replace predonation of autologous blood or intraoperative autotransfusion requires further study 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 UNLABELLED Perioperative bleeding following coronary artery bypass grafting ( CABG ) is associated with increased blood product usage . Although aprotonin is effective in reducing perioperative blood loss , excessive cost prohibits routine utilization . Epsilon aminocaproic acid ( EACA ) and tranexamic acid ( TA ) are inexpensive antifibrinolytic agents , which , when given prophylactically , may reduce blood loss . The present study was undertaken to compare the efficacy of TA and EACA in reducing perioperative blood loss . METHODS The study population consisted of first-time CABG patients . Patients were allocated in a prospect i ve double-blind fashion : ( 1 ) group EACA ( loading dose 15 mg/kg , continuous infusion 10 mg/kg per hour for 6 hours , N = 20 ) ; ( 2 ) group TA ( loading dose 15 mg/kg , continuous infusion 1 mg/kg per hour for 6 hours , N = 20 ) ; ( 3 ) control group ( infusion of normal saline for 6 hours , N = 19 ) . RESULTS Treatment groups were similar preoperatively . No significant difference in intraoperative blood loss or perioperative use of blood products was noted . D-dimer concentration was elevated in the control group compared to the EACA and TA groups ( p < 0.05 ) . Group TA had less postoperative blood loss than the EACA and control groups at 6 and 12 hours postoperatively ( p < 0.05 ) . TA had reduced total blood loss ( 600 + /- 49 mL ) postoperatively compared to EACA ( 961 + /- 148 mL ) and control ( 1060 + /- 127 mL , p < 0.05 ) . CONCLUSION TA and EACA effectively inhibited fibrinolytic activity intraoperatively and throughout the first 24 hours postoperatively . TA was more effective in reducing blood loss postoperatively following CABG . This suggests that TA may be beneficial as an effective and inexpensive antifibrinolytic in first-time CABG patients BACKGROUND The transfusion of allogeneic red blood cells and allogeneic coagulation products is associated with risk to the patient and the depletion of an increasingly scarce re source . This prospect i ve , r and omized , double-blind , placebo-controlled trial investigated practice s to avoid transfusion in patients undergoing first-time cardiac surgery . METHODS Patients were r and omized to one of three treatment groups : an aprotinin group , a tranexamic acid group , and a control group receiving normal saline . Intra-operative cell salvage was used for all patients . The primary outcomes were the number of patients exposed to allogeneic red blood cells , allogeneic coagulation products or any allogeneic transfusion ( allogeneic red blood cells and /or allogeneic coagulation products ) . RESULTS Patients were 2.5 times more likely to receive any allogeneic transfusion in the tranexamic group than in the aprotinin group ( 21 patients out of 60 compared with nine out of 60 , respectively ) . The relative risk of any allogeneic transfusion comparing aprotinin with tranexamic acid was 0.43 ( 95 % confidence interval 0.21 - 0.86 ; P=0.019 ) . Patients in the control group were four times more likely to receive any allogeneic transfusion when compared with the aprotinin group ( 37 patients out of 60 compared with nine out of 60 , respectively ) . The relative risk of any allogeneic transfusion comparing aprotinin with control was 0.24 ( 95 % confidence interval 0.13 - 0.46 ; P<0.001 ) . CONCLUSIONS When used in addition to intra-operative cell salvage , aprotinin is the most efficacious pharmacological therapy for reducing patient exposure to any allogeneic transfusion during first-time cardiac surgery 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 We performed a r and omized , double-blind study on the effect of tranexamic acid on blood loss and blood transfusions in 40 primary total hip arthroplasties . Tranexamic acid , 10 mg/kg body weight , or placebo , was given intravenously just before the operation . Blood loss during the operation and postoperatively into the drains was recorded , as also were blood hemoglobin concentrations . Ultrasound examination 1 week postoperatively was done to estimate the blood loss due to remaining hematomas . Total ( operation + drain ) blood loss was 0.76 ( 95 % CI 0.63 - 0.89 ) L in the tranexamic acid group as compared to 1.0 ( CI 0.81 - 1.2 ) L in the placebo group ( p = 0.03 ) . The number of blood transfusions during the day of operation was 2 vs. 10 ( p = 0.07 ) and the total number during the hospital stay was 5 vs. 13 ( p = 0.2 ) . 1 patient in each group had a pulmonary embolism Tranexamic acid was used to reduce postoperative drainage and allogenic blood transfusion requirements in patients undergoing on-pump primary coronary bypass surgery . Over 12 months , 222 patients participated in this prospect i ve , r and omized , placebo-controlled , double-blind study conducted at a tertiary center . Half of the patients were r and omly allocated to receive tranexamic acid as a bolus ( 10 mg·kg−1 ) prior to sternotomy , followed by an infusion ( 1 mg·kg−1·hr−1 ) up to the time of starting of protamine . The other 111 patients received a saline bolus and infusion . Postoperative drainage and transfusion requirements were measured in all patients . Markers of graft patency , hemostasis , hemodynamic stability , and fibrinolysis were evaluated . Chest closure time , renal function parameters , allergic reactions , incidence of stroke , re-exploration , and hospital mortality were also noted . Postoperative drainage was significantly less and blood conservation considerably better when tranexamic acid was used . Post-bypass hemostasis was achieved faster , fibrinolysis was less , and there was no evidence of increased incidence of graft occlusion in the group given tranexamic acid The administration of tranexamic acid ( TA ) prior to cardiopulmonary bypass ( CPB ) has been associated with reduced bleeding during and after cardiac surgery . In a prospect i ve , r and omized , controlled , double-blind clinical trial , adult patients undergoing repeat open heart surgery received TA ( n = 17 ) or an equal volume of saline placebo ( n = 13 ) . In the TA group , a 20-mg/kg intravenous ( IV ) initial dose of TA at skin incision was followed by an infusion of 2 mg centered dot kg-1 centered dot h-1 , which continued for the duration of the surgical procedure . Identical transfusion guidelines were followed in both groups . Routine coagulation tests , D-dimer levels , mediastinal tube drainage , and transfusion requirements were compared . Cumulative postoperative mediastinal tube drainage measured at 24 h was 649 + /- 391 mL ( mean + /- SD ) in the TA group compared with 923 + /- 496 mL in the placebo group ( P < 0.01 ) . Forty-eight- and 72-h mediastinal tube drainage were also significantly less in the TA group ( P < 0.01 ) . Seven of 17 TA patients received no transfusion of allogene
Output:
| The effect of TXA on blood loss did not vary over the range of doses assessed ( 5·5 - 300 mg/kg ) .
CONCLUSION TXA reduces blood loss in surgical patients by about one-third .
A total dose of 1 g appears to be sufficient for most adults .
There is no evidence to support the use of high doses |
MS213194 | ***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 This pharmacologic protection trial was conducted to test the hypothesis that allopurinol , a scavenger and inhibitor of oxygen free radical production , could reduce death , seizures , coma , and cardiac events in infants who underwent heart surgery using deep hypothermic circulatory arrest ( DHCA ) . DESIGN This was a single center , r and omized , placebo-controlled , blinded trial of allopurinol in infant heart surgery using DHCA . Enrolled infants were stratified as having hypoplastic left heart syndrome ( HLHS ) and all other forms of congenital heart disease ( non-HLHS ) . Drug was administered before , during , and after surgery . Adverse events and the clinical efficacy endpoints death , seizures , coma , and cardiac events were monitored until infants were discharged from the intensive care unit or 6 weeks , whichever came first . RESULTS Between July 1992 and September 1997 , 350 infants were enrolled and 348 subsequently r and omized . A total of 318 infants ( 131 HLHS and 187 non-HLHS ) underwent heart surgery using DHCA . There was a nonsignificant treatment effect for the primary efficacy endpoint analysis ( death , seizures , and coma ) , which was consistent over the 2 strata . The addition of cardiac events to the primary endpoint result ed in a lack of consistency of treatment effect over strata , with the allopurinol treatment group experiencing fewer events ( 38 % vs 60 % ) in the entire HLHS stratum , compared with the non-HLHS stratum ( 30 % vs 27 % ) . In HLHS surgical survivors , 40 of 47 ( 85 % ) allopurinol-treated infants did not experience any endpoint event , compared with 27 of 49 ( 55 % ) controls . There were fewer seizures-only and cardiac-only events in the allopurinol versus placebo groups . Allopurinol did not reduce efficacy endpoint events in non-HLHS infants . Treated and control infants did not differ in adverse events . CONCLUSIONS Allopurinol provided significant neurocardiac protection in higher-risk HLHS infants who underwent cardiac surgery using DHCA . No benefits were demonstrated in lower risk , non-HLHS infants , and no significant adverse events were associated with allopurinol treatment.congenital heart defects , hypoplastic left heart syndrome , induced hypothermia , ischemia-reperfusion injury , neuroprotective agents , allopurinol , xanthine oxidase , free radicals , seizures , coma Background : It is unknown whether intraoperative hyperglycemia in infants is associated with worse neurodevelopmental outcomes after low-flow cardiopulmonary bypass ( LF ) , deep hypothermic circulatory arrest ( CA ) , or both . Methods : In a data base review of a prospect i ve trial of 171 infants undergoing arterial switch for D-transposition of the great arteries who were r and omly assigned to predominately LF or CA , glucose was measured after induction ( T1 ) , 5 min after cardiopulmonary bypass onset ( T2 ) , at the onset of CA or LF ( T3 ) , 5 min after CPB resumption ( T4 ) , at rewarming to 32 ° C ( T5 ) , 10 min after cardiopulmonary bypass weaning ( T6 ) , and 90 min after CA or LF ( T7 ) . Outcomes included seizures , electroencephalographic findings , and neurodevelopmental evaluation at 1 , 4 , and 8 yr . Results : Glucose concentrations were affected by support strategy and age at surgery . Lower glucose in the entire group at T6–T7 tended to predict electroencephalographic seizures ( P = 0.06 and P = 0.007 ) but was not related to clinical seizures . Within the predominantly CA group , higher glucose did not correlate with worse outcomes . Rather , it was associated with more rapid electroencephalographic normalization of “ close burst ” and “ relative continuous ” activity at all times except T2 ( P ≤ 0.03 ) , a finding more pronounced in infants aged 7 days old or younger . Intraoperative serum glucose concentrations were unrelated to neurodevelopmental outcomes at ages 1 , 4 , and 8 yr . Conclusions : Low glucose after cardiopulmonary bypass tended to relate to electroencephalographic seizures and slower electroencephalogram recovery , independent of CA duration . High glucose concentrations were not associated with worse neurodevelopmental outcomes . Avoiding hypoglycemia may be preferable to restricting glucose in infants undergoing heart surgery OBJECTIVE : The goal was to examine biochemical , neurophysiologic , anatomic , and clinical changes associated with erythropoietin administration to neonates with hypoxic-ischemic encephalopathy ( HIE ) . METHODS : We conducted a prospect i ve case-control study with 45 neonates in 3 groups , a normal healthy group ( N = 15 ) , a HIE-erythropoietin group ( N = 15 ; infants with mild/moderate HIE who received human recombinant erythropoietin , 2500 IU/kg , subcutaneously , daily for 5 days ) , and a HIE-control group ( N = 15 ; did not receive erythropoietin ) . Serum concentrations of nitric oxide ( NO ) were measured at enrollment for the normal healthy neonates and at enrollment and after 2 weeks for the 2 HIE groups . The 2 HIE groups underwent electroencephalography at enrollment and at 2 to 3 weeks . Brain MRI was performed at 3 weeks . Neurologic evaluations and Denver Developmental Screening Test II assessment s were performed at 6 months . RESULTS : Compared with normal healthy neonates , the 2 HIE groups had greater blood NO concentrations ( P < .001 ) . At enrollment , the 2 HIE groups did not differ in clinical severity , seizure incidence , NO concentrations , or electroencephalographic findings . At 2 weeks of age , electroencephalographic background s improved significantly ( P = .01 ) and NO concentrations decreased ( P < .001 ) in the HIE-erythropoietin group , compared with the HIE-control group ; MRI findings did not differ between groups . At 6 months of age , infants in the HIE-erythropoietin group had fewer neurologic ( P = .03 ) and developmental ( P = .03 ) abnormalities . CONCLUSION : This study demonstrates the feasibility of early administration of human recombinant erythropoietin to term neonates with HIE , to protect against encephalopathy Objectives To evaluate plasma brain specific proteins and cytokines as biomarkers of brain injury in newborns with hypoxic‐ischemic encephalopathy ( HIE ) and , secondarily , to assess the effect of erythropoietin ( Epo ) treatment on the relationship between biomarkers and outcomes . Study design A study of c and i date brain injury biomarkers was conducted in the context of a phase II multicenter r and omized trial evaluating Epo for neuroprotection in HIE . Plasma was collected at baseline ( < 24 hours ) and on day 5 . Brain injury was assessed by magnetic resonance imaging ( MRI ) and neurodevelopmental assessment s at 1 year . The relationships between Epo , brain‐specific proteins ( S100B , ubiquitin carboxy‐terminal hydrolase‐L1 [ UCH‐L1 ] , total Tau , neuron specific enolase ) , cytokines ( interleukin [IL]‐1&bgr ; , IL‐6 , IL‐8 , IL‐10 , IL‐12P70 , IL‐13 , interferon‐gamma [ IFN‐&ggr ; ] , tumor necrosis factor alpha [ TNF‐&agr ; ] , brain‐derived neurotrophic factor [ BDNF ] , monocyte chemoattractant protein‐1 ) , and brain injury were assessed . Results In 50 newborns with encephalopathy , elevated baseline S100B , Tau , UCH‐L1 , IL‐1&bgr ; , IL‐6 , IL‐8 , IL‐10 , IL‐13 , TNF‐&agr ; , and IFN‐&ggr ; levels were associated with increasing brain injury severity by MRI . Higher baseline Tau and lower day 5 BDNF were associated with worse 1 year outcomes . No statistically significant evidence of Epo treatment modification on biomarkers was detected in this small cohort . Conclusions Elevated plasma brain‐specific proteins and cytokine levels in the first 24 hours of life are associated with worse brain injury by MRI in newborns with HIE . Only Tau and BDNF levels were found to be related to neurodevelopmental outcomes . The effect of Epo treatment on the relationships between biomarkers and brain injury in HIE requires further study . Trial registration Clinical Trials.gov : 01913340 Objective : Infants are potentially more susceptible to cell death mediated via glutamate excitotoxicity attributed to cardiopulmonary bypass . We hypothesized that ketamine , via N-methyl D-aspartate receptor blockade and anti-inflammatory effects , would reduce central nervous system injury during cardiopulmonary bypass . Methods : We r and omized 24 infants , without chromosomal abnormalities , to receive ketamine ( 2 mg/kg , n = 13 ) or placebo ( saline , n = 11 ) before cardiopulmonary bypass for repair of ventricular septal defects . Plasma markers of inflammation and central nervous system injury were compared at the end of surgery , and 6 , 24 , and 48 hrs after surgery . Magnetic resonance imaging and spectroscopy before cardiopulmonary bypass and at the time of hospital discharge were performed in a subset of cases and controls ( n = 5 in each group ) . Cerebral hemodynamics were monitored postoperatively using near-infrared spectroscopy , and neurodevelopmental outcomes were assessed using Bayley Scales of Infant Development-II before and 2–3 wks after surgery . Results : Statistically significant differences were noted in preoperative inspired oxygen levels , intraoperative cooling and postoperative temperature , respiratory rate , platelet count , and bicarbonate levels . The peak concentration of C-reactive protein was lower in cases compared to controls at 24 hrs ( p = .048 ) and 48 hrs ( p = .001 ) . No significant differences were noted in the expression of various cytokines , chemokines , S100 , and neuron-specific enolase between the cases and controls . Magnetic resonance imaging with spectroscopy studies showed that ketamine administration led to a significant decrease in choline and glutamate plus glutamine/creatine in frontal white matter . No statistically significant differences occurred between pre- and postoperative Bayley Scales of Infant Development-II scores . Conclusions : We did not find any evidence for neuroprotection or neurotoxicity in our pilot study . A large , adequately powered r and omized control trial is needed to discern the central nervous system effect of ketamine on the developing brain . brain . Trial Registration : The trial is registered at www . Clinical Trials.gov , NCT00556361 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVE : The purpose of this study was to evaluate the efficacy and safety of erythropoietin in neonatal hypoxic-ischemic encephalopathy ( HIE ) , by using a r and omized , prospect i ve study design . METHODS : A total of 167 term infants with moderate/severe HIE were assigned r and omly to receive either erythropoietin ( N = 83 ) or conventional treatment ( N = 84 ) . Recombinant human erythropoietin , at either 300 U/kg ( N = 52 ) or 500 U/kg ( N = 31 ) , was administered every other day for 2 weeks , starting < 48 hours after birth . The primary outcome was death or disability . Neurodevelopmental outcomes were assessed at 18 months of age . RESULTS : Complete outcome data were available for 153 infants . Nine patients dropped out during treatment , and 5 patients were lost to follow-up monitoring . Death or moderate/severe disability occurred for 35 ( 43.8 % ) of 80 infants in the control group and 18 ( 24.6 % ) of 73 infants in the erythropoietin group ( P = .017 ) at 18 months . The primary outcomes were not different between the 2 erythropoietin doses . Subgroup analyses indicated that erythropoietin improved long-term outcomes only for infants with moderate HIE ( P = .001 ) and not those with severe HIE ( P = .227 ) . No negative hematopoietic side effects were observed . CONCLUSION : Repeated , low-dose , recombinant human erythropoietin treatment reduced the risk of disability for infants with moderate HIE , without apparent side effects Background — Complex neonatal cardiac surgery is associated with cerebral injury . In particular , aortic arch repair , requiring either deep hypothermic circulatory arrest ( DHCA ) or ante grade cerebral perfusion ( ACP ) , entails a high risk of perioperative injury . It is unknown whether ACP results in less cerebral injury than D
Output:
| Erytropoietin , ketamine and dextromethorphan showed no neuroprotective effects .
Conclusions : Allopurinol seems promising for future trials in congenital heart disease infants to reduce brain injury given the early neuroprotective effects in hypoplastic left heart syndrome infants . |
MS213195 | ***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: Patients with type 2 diabetes mellitus ( T2DM ) with a glycated haemoglobin ( HbA1c ) level ≥7 and ≤10 % were r and omized to receive empagliflozin 12.5 mg twice daily ( n = 219 ) , 25 mg once daily ( n = 218 ) , 5 mg twice daily ( n = 219 ) or 10 mg once daily ( n = 220 ) , or placebo ( n = 107 ) as add‐on to stable‐dose metformin immediate release ( IR ) twice daily for 16 weeks . The primary endpoint was change from baseline in HbA1c at week 16 . At week 16 , change from baseline in HbA1c with empagliflozin twice daily was non‐inferior to empagliflozin once daily and vice versa . The adjusted mean ( 95 % confidence interval ) difference in change from baseline in HbA1c with empagliflozin 12.5 mg twice daily versus 25 mg once daily was −0.11 % ( −0.26 , 0.03 ) , and with empagliflozin 5 mg twice daily versus 10 mg once daily it was −0.02 % ( −0.16 , 0.13 ) . All empagliflozin regimens were well tolerated ; thus , when used as add‐on to metformin IR in patients with T2DM , the therapeutic effect of empagliflozin twice‐daily and once‐daily regimens can be considered equivalent OBJECTIVE This study compared the efficacy and safety of initial combinations of empagliflozin + metformin with empagliflozin and metformin monotherapy in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS The study r and omized 1,364 drug-naïve patients ( HbA1c > 7.5 to ≤12 % [ > 58 to ≤108 mmol/mol ] ) for 24 weeks to empagliflozin 12.5 mg b.i.d . + metformin 1,000 mg b.i.d . , empagliflozin 12.5 mg b.i.d . + metformin 500 mg b.i.d . , empagliflozin 5 mg b.i.d + metformin 1,000 mg b.i.d . , empagliflozin 5 mg b.i.d . + metformin 500 mg b.i.d . , empagliflozin 25 mg q.d . , empagliflozin 10 mg q.d . , metformin 1,000 mg b.i.d . , or metformin 500 mg b.i.d . The primary end point was change from baseline in HbA1c at week 24 . RESULTS At week 24 , reductions in HbA1c ( mean baseline 8.6–8.9 % [ 70–73 mmol/mol ] ) were −1.9 to −2.1 % with empagliflozin + metformin twice-daily regimens , −1.4 % with both empagliflozin once-daily regimens , and −1.2 to −1.8 % with metformin twice-daily regimens . Reductions in HbA1c were significantly greater with empagliflozin + metformin twice-daily regimens than with empagliflozin once-daily regimens ( P < 0.001 ) and with metformin twice-daily regimens ( P < 0.01 ) . Reductions in weight at week 24 were significantly greater with empagliflozin + metformin twice-daily regimens ( range −2.8 to −3.8 kg ) than with metformin twice-daily regimens ( −0.5 to −1.3 kg ) ( P < 0.001 for all ) . Adverse event ( AE ) rates were similar across groups ( 56.7–66.3 % ) . No hypoglycemic AEs required assistance . CONCLUSIONS Initial combinations of empagliflozin + metformin for 24 weeks significantly reduced HbA1c versus empagliflozin once daily and metformin twice daily , without increased hypoglycemia , reduced weight versus metformin twice daily , and were well tolerated OBJECTIVE To evaluate the effects of canagliflozin , a sodium-glucose cotransporter 2 inhibitor , in type 2 diabetes mellitus inadequately controlled with metformin monotherapy . RESEARCH DESIGN AND METHODS This was a double-blind , placebo-controlled , parallel-group , multicenter , dose-ranging study in 451 subjects r and omized to canagliflozin 50 , 100 , 200 , or 300 mg once daily ( QD ) or 300 mg twice daily ( BID ) , sitagliptin 100 mg QD , or placebo . Primary end point was change in A1C from baseline through week 12 . Secondary end points included change in fasting plasma glucose ( FPG ) , body weight , and overnight urinary glucose-to-creatinine ratio . Safety and tolerability were also assessed . RESULTS Canagliflozin was associated with significant reductions in A1C from baseline ( 7.6–8.0 % ) to week 12 : −0.79 , −0.76 , −0.70 , −0.92 , and −0.95 % for canagliflozin 50 , 100 , 200 , 300 mg QD and 300 mg BID , respectively , versus −0.22 % for placebo ( all P < 0.001 ) and −0.74 % for sitagliptin . FPG was reduced by −16 to −27 mg/dL , and body weight was reduced by −2.3 to −3.4 % , with significant increases in urinary glucose-to-creatinine ratio . Adverse events were transient , mild to moderate , and balanced across arms except for a non – dose-dependent increase in symptomatic genital infections with canagliflozin ( 3–8 % ) versus placebo and sitagliptin ( 2 % ) . Urinary tract infections were reported without dose dependency in 3–9 % of canagliflozin , 6 % of placebo , and 2 % of sitagliptin arms . Overall incidence of hypoglycemia was low . CONCLUSIONS Canagliflozin added onto metformin significantly improved glycemic control in type 2 diabetes and was associated with low incidence of hypoglycemia and significant weight loss . The safety/tolerability profile of canagliflozin was favorable except for increased frequency of genital infections in females OBJECTIVE To evaluate the efficacy and safety of combinations of empagliflozin/linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin . RESEARCH DESIGN AND METHODS Subjects were r and omized to a combination of empagliflozin 25 mg/linagliptin 5 mg ( n = 137 ) , empagliflozin 10 mg/linagliptin 5 mg ( n = 136 ) , empagliflozin 25 mg ( n = 141 ) , empagliflozin 10 mg ( n = 140 ) , or linagliptin 5 mg ( n = 132 ) as add-on to metformin for 52 weeks . The primary end point was change from baseline in HbA1c at week 24 . RESULTS At week 24 , reductions in HbA1c ( mean baseline 7.90–8.02 % [ 62.8–64.1 mmol/mol ] ) with empagliflozin/linagliptin were superior to those with empagliflozin or linagliptin alone as add-on to metformin ; adjusted mean ( SE ) changes from baseline were −1.19 % ( 0.06 ) ( −13.1 mmol/mol [ 0.7 ] ) with empagliflozin 25 mg/linagliptin 5 mg , −1.08 % ( 0.06 ) ( −11.8 mmol/mol [ 0.7 ] ) with empagliflozin 10 mg/linagliptin 5 mg , −0.62 % ( 0.06 ) ( −6.8 mmol/mol [ 0.7 ] ) with empagliflozin 25 mg , −0.66 % ( 0.06 ) ( −7.2 mmol/mol [ 0.7 ] ) with empagliflozin 10 mg , and −0.70 % ( 0.06 ) ( −7.6 mmol/mol [ 0.7 ] ) with linagliptin 5 mg ( P < 0.001 for all comparisons ) . In these groups , respectively , 61.8 , 57.8 , 32.6 , 28.0 , and 36.1 % of subjects with baseline HbA1c ≥7 % ( ≥53 mmol/mol ) had HbA1c < 7 % ( < 53 mmol/mol ) at week 24 . Efficacy was maintained at week 52 . The proportion of subjects with adverse events ( AEs ) over 52 weeks was similar across treatment arms ( 68.6–73.0 % ) , with no hypoglycemic AEs requiring assistance . CONCLUSIONS Combinations of empagliflozin/linagliptin as second-line therapy for 52 weeks significantly reduced HbA1c compared with the individual components and were well tolerated OBJECTIVE To investigate the efficacy , safety , and tolerability of empagliflozin in patients with type 2 diabetes and hypertension . RESEARCH DESIGN AND METHODS Patients ( N = 825 ) with type 2 diabetes and hypertension ( mean seated systolic blood pressure [ SBP ] 130–159 mmHg and diastolic blood pressure [ DBP ] 80–99 mmHg ) were r and omized ( double blind ) to 10 mg or 25 mg empagliflozin or placebo once daily for 12 weeks . RESULTS At week 12 , adjusted mean difference versus placebo in change from baseline in mean 24-h SBP ( ambulatory blood pressure monitoring [ ABPM ] ) was −3.44 mmHg ( 95 % CI −4.78 , −2.09 ) with 10 mg empagliflozin and −4.16 mmHg ( −5.50 , −2.83 ) with 25 mg empagliflozin ( both P < 0.001 ) . At week 12 , adjusted mean difference versus placebo in change from baseline in mean 24-h DBP ( ABPM ) was −1.36 mmHg ( 95 % CI −2.15 , −0.56 ) with 10 mg empagliflozin and −1.72 mmHg ( 95 % CI −2.51 , −0.93 ) with 25 mg empagliflozin ( both P < 0.001 ) . Changes in office BP were consistent with ABPM . Adjusted mean difference versus placebo in change from baseline in HbA1c at week 12 was −0.62 % ( 95 % CI −0.72 , −0.52 ) ( −6.8 mmol/mol [ 95 % CI −7.9 , −5.7 ] ) with 10 mg empagliflozin and −0.65 % ( 95 % CI −0.75 , −0.55 ) ( −7.1 mmol/mol [ 95 % CI −8.2 , −6.0 ] ) with 25 mg empagliflozin ( both P < 0.001 ) . Empagliflozin was well tolerated . One patient on placebo and one patient on 10 mg empagliflozin reported events consistent with volume depletion . CONCLUSIONS Empagliflozin was associated with significant and clinical ly meaningful reductions in BP and HbA1c versus placebo and was well tolerated in patients with type 2 diabetes and hypertension This r and omized , double-blind , placebo-controlled study evaluated the early effects of canagliflozin on blood pressure ( BP ) in patients with type 2 diabetes mellitus ( T2DM ) and hypertension . Patients were r and omized to canagliflozin 300 mg , canagliflozin 100 mg , or placebo for 6 weeks and underwent 24-hour ambulatory BP monitoring before r and omization , on day 1 of treatment , and after 6 weeks . The primary endpoint was change in mean 24-hour systolic BP ( SBP ) from baseline to week 6 . Overall , 169 patients were included ( mean age , 58.6 years ; glycated hemoglobin , 8.1 % ; seated BP 138.5/82.7 mm Hg ) . At week 6 , canagliflozin 300 mg provided greater reductions in mean 24-hour SBP than placebo ( least squares mean -6.2 vs -1.2 mm Hg , respectively ; P=.006 ) . Numerical reductions in SBP were observed with canagliflo
Output:
| No increased risk for either outcome was found when compared with active controls .
Subgroup analysis did show an increased risk of UTI with dapagliflozin only ( RR 1.21 ; 95 % CI 1.02 to 1.43 , I2=0.0 % ) , but no other analysis supported an increased risk of AKI , DKA , UTI or fracture .
CONCLUSIONS Current evidence from RCTs does not suggest an increased risk of harm with SGLT2 inhibitors as a class over placebo or active comparators with respect to AKI , DKA , UTI or fracture .
Dapagliflozin , appears to independently increase the risk of UTI , although the mechanism for this intraclass variation in risk is unclear . |
MS213196 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background There are very few studies on the frequency of breakfast and snack consumption and its relation to fruit and vegetable intake . This study aims to fill that gap by exploring the relation between irregular breakfast habits and snack consumption and fruit and vegetable intake in Tuscan adolescents . Separate analyses were conducted with an emphasis on the potentially modifying factors of sex and age . Methods Data was obtained from the 2010 Tuscan sample of the Health Behaviour in School-aged Children ( HBSC ) study . The HBSC study is a cross-sectional survey of 11- , 13- and 15-year-old students ( n = 3291 ) , selected from a r and om sample of schools . Multivariate logistic regression was used for analyzing the food-frequency question naire . Results A significant relation was found between low fruit and vegetable intake and irregular breakfast habits . Similarly , low fruit intake was associated with irregular snack consumption , whereas vegetable intake did not prove to be directly related to irregular snack consumption . Different patterns emerged when gender and age were considered as modifying factors in the analyses . A statistically significant relation emerged only among female students for irregular breakfast habits and fruit and vegetable intake . Generally , older female participants with irregular breakfast habits demonstrated a higher risk of low fruit and vegetable intake . Age pattern varied between genders , and between fruit and vegetable consumption . Conclusions Results suggest that for those adolescents who have an irregular consumption of breakfast and snacks , fruit intake occurs with a lower frequency . Lower vegetable consumption was associated with irregular breakfast consumption . Gender and age were shown to be moderators and this indicated the importance of analyzing fruit and vegetable intake and meal types separately . This study also confirmed that health-promotion campaigns that aim to promote regular meal consumption and consumption of fruits and vegetables need to take into account gender and age differences in design ing promotional strategies . Future research should identify evidence -based interventions to facilitate the achievement of the Italian guidelines for a healthy diet for fruit , vegetables and meals intake Twenty-nine schoolchildren were tested throughout the morning on 4 successive days , having a different breakfast each day ( either of the cereals Cheerios or Shreddies , glucose drink or No breakfast ) . A series of computerised tests of attention , working memory and episodic secondary memory was conducted prior to breakfast and again 30 , 90 , 150 and 210 min later . The glucose drink and No breakfast conditions were followed by declines in attention and memory , but the declines were significantly reduced in the two cereal conditions . This study provides objective evidence that a typical breakfast of cereal rich in complex carbohydrates can help maintain mental performance over the morning BACKGROUND / OBJECTIVES Aside from the health consequences , observational studies indicate that being overweight may also negatively affect cognitive function . However , existing evidence has to a large extent not controlled for the possible confounding effect of having different lifestyles . Therefore , the objective was to examine the independent associations between weight status and lifestyle indicators with cognitive performance in 8 - 11year old Danish children . SUBJECTS/ METHODS The analyses included 828 children ( measured in 2011 - 2012 ) each having one to three measurement occasions separated by approximately 100days . Dietary intake , physical activity , sedentary time , and sleep duration were measured using dietary records and accelerometers . The Children 's Sleep Habits Question naire was used to access sleep problems and the And ersen test was carried out to estimate cardio-respiratory fitness ( CRF ) . Weight status ( underweight , normal weight , and overweight/obese ) was defined according to body mass index and cognitive performance was assessed using the d2-test of attention , a reading test , and a math test . A linear mixed model including a number of fixed and r and om effects was used to test associations between lifestyle indicators as well as BMI category and cognitive performance . RESULTS After adjustment for demographics , socioeconomics , and multiple lifestyle indicators , normal weight children had higher cognitive test scores than overweight/obese and underweight children of up to 89 % and 48 % of expected learning within one school year ( P<0.05 ) . Daily breakfast consumption , fewer sleep problems , higher CRF , less total physical activity , more sedentary time , and less light physical activity were associated with higher cognitive performance independently of each other in at least one of the three cognitive tests ( P<0.05 ) . CONCLUSIONS Normal weight children had higher cognitive performance compared to overweight/obese as well as underweight children , independent of multiple lifestyle indicators OBJECTIVE . The goal was to determine whether breakfast had effects on the cognitive performance and mood of high school students . METHODS . A crossover trial was performed in boarding schools , involving 104 students between 13 and 20 years of age . The participants were r and omly assigned to 2 equal-size groups on the morning of the first testing day . One half of the total sample received a st and ardized breakfast , whereas the other half received no breakfast . Seven days later , the treatment order was reversed . Measurements of cognitive function included st and ardized tests of attention and concentration , as well as tests of verbal and spatial memory . In addition , mood was rated with a self-administered question naire covering the dimensions of positive and negative affect , information uptake , arousal , and alertness . Statistical analysis consisted of repeated- measures analysis of variance . RESULTS . Breakfast had no effect on sustained attention among high school students . Visuospatial memory was improved in male students . Self-reported alertness improved significantly in the entire study population . Male students reported feeling more positive after consuming breakfast , compared with the fasting condition . CONCLUSIONS . This crossover trial demonstrated positive short-term effects of breakfast on cognitive functioning and self-reported alertness in high school students This study examined the effects of breakfast consumption on cognitive function , mood and blood glucose concentration in adolescent schoolchildren . With the institution 's ethical advisory committee approval , 96 adolescents ( 12 to 15 years old ) completed two r and omly assigned trials ( one following breakfast consumption and one following breakfast omission ) , scheduled 7 days apart . Cognitive function tests ( visual search test , Stroop test and Sternberg paradigm ) , a mood question naire and a finger prick blood sample ( in a subgroup of 60 participants ) were completed immediately following breakfast and 120 min after the baseline measures . Following breakfast consumption , accuracy on the more complex level of the visual search test was higher than following breakfast omission ( p=0.021 ) . Similarly , accuracy on the Stroop test was better maintained across the morning following breakfast consumption when compared to breakfast omission ( p=0.022 ) . Furthermore , responses on the Sternberg paradigm were quicker later in the morning following breakfast consumption , particularly on the more complex levels ( p=0.012 ) . Breakfast consumption also produced higher self-report energy and fullness , lower self-report tiredness and hunger and higher blood glucose concentrations ( all p<0.0005 ) . Overall , the findings of the present study suggest that breakfast consumption enhances cognitive function in an adolescent population when compared to breakfast omission
Output:
| The results of the review of eating breakfast studies showed positive and conclusive effects on cognitive performance , academic achievement , quality of life , well-being and on morbidity risk factors .
Conclusions The overall assessment of the studies indicated positive effects of eating breakfast . |
MS213197 | ***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 Cardiopulmonary bypass ( CPB ) is widely regarded as an important contributor to renal failure , a well recognized complication following coronary artery surgery ( coronary artery bypass grafting ( CABG ) ) . Anecdotally off-pump coronary surgery ( OPCAB ) is considered renoprotective . We examine the extent of renal glomerular and tubular injury in low-risk patients undergoing either OPCAB or on-pump coronary artery bypass ( ONCAB ) . METHODS Forty low-risk patients with normal preoperative cardiac and renal functions awaiting elective CABG were prospect ively r and omized into those undergoing OPCAB ( n=20 ) and ONCAB ( n=20 ) . Glomerular and tubular injury were measured respectively by urinary excretion of microalbumin and retinol binding protein ( RBP ) indexed to creatinine ( Cr ) . Daily measurements were taken from admission to postoperative day 5 . Fluid balance , serum Cr and blood urea were also monitored . RESULTS No mortality or renal complication were observed . Both groups had similar demographic makeup , Parsonnet score , functional status and extent of coronary revascularization ( 2.1+/-1.0 vs. 2.5+/-0.7 grafts ; P=0.08 ) . Serum Cr and blood urea remained normal in both groups throughout the study . A significant and similar rise in urinary RBP : Cr occurred in both groups peaking on day 1 ( 3183+/-2534 vs. 4035+/-4079 ; P=0.43 ) before reapproximating baseline levels . These trends were also observed with urinary microalbumin : Cr ( 5.05+/-2.66 vs. 6.77+/-5.76 ; P=0.22 ) . Group B patients had a significantly more negative fluid balance on postoperative day 2 ( -183+/-1118 vs. 637+/-847 ml ; P=0.03 ) . CONCLUSIONS Although renal complication or serum markers of kidney dysfunction were absent , sensitive indicators revealed significant and similar injury to renal tubules and glomeruli following either OPCAB or ONCAB . These results suggest that avoidance of CPB does not offer additional renoprotection to patients at low risk of perioperative renal insult during CABG BACKGROUND Pulmonary dysfunction is still a major problem in coronary artery bypass grafting ( CABG ) . The purpose of this r and omized study was to determine the effect of different CABG techniques on pulmonary function . METHODS Fifty eight patients with severe obstructive pulmonary disease had elective isolated coronary surgery . The surgical methods for the patients with chronic obstructive pulmonary disease ( COPD ) were st and ard CABG in 18 patients ( group 1 ) , beating heart surgery in 19 patients ( group 2 ) , and minimally invasive direct coronary artery bypass grafting ( MIDCABG ) in 21 patients ( group 3 ) . RESULTS The earliest extubation time was from group 3 ( p < 0.001 ) . The average stay in the intensive care unit was significantly longer in group 1 ( 2.6 + /- 1.5 days ) than in groups 2 ( 1.4 + /- 0.8 days ) and 3 ( 1.1 + /- 0.8 days ) ( p < 0.05 ) . The most prevalent respiratory morbidity was atelectasis that developed in 6 patients from group 1 , in 2 patients from group 2 , and in 3 patients from group 3 . Forced expiratory volumes in 1 second ( FEV1 ) obtained in the second postoperative month were significantly lower than preoperative values only in group 1 ( p < 0.05 ) . Forced vital capacity ( FVC ) values were significantly lower than the preoperative values in all three groups ( p < 0.05 ) . CONCLUSIONS Off-pump bypass surgical procedures are more advantageous than on-pump methods for patients with COPD . These patients can be operated on using the beating heart technique or by using MIDCABG to prevent side effects of CPB on pulmonary function and effects of sternotomy AIMS Uncertainty persists regarding the impact of the off-pump technique on coronary bypass graft patency . The primary objective of this study was to assess coronary artery bypass graft patency in patients r and omized to off-pump and on-pump multivessel coronary artery bypass grafting ( CABG ) . Secondary objectives were clinical outcomes and neuropsychological functioning . METHODS AND RESULTS One hundred and fifty patients were r and omized to off-pump ( n = 75 ) or on-pump CABG ( n = 75 ) . Graft patency was assessed by multidetector computed tomography 5 weeks after surgery . The two groups were similar regarding patients ' characteristics and logistic Euroscore ( 3.6 vs. 3.7 % ) . Mean number of grafts performed was 3.5 ± 0.6 and 3.5 ± 0.6 in off-pump and on-pump , respectively ( P = 0.7 ) . Raw graft patency rate was 89.9 % in off-pump and 95.0 % in on-pump ( OR 2.2 , 95 % CI 1.07 - 4.44 ; P = 0.03 ) . Nineteen ( 27 % ) off-pump and 9 ( 13 % ) on-pump patients had at least one occluded graft ( P = 0.04 ) and the proportion of patent grafts per patient was 0.91 ± 0.2 in off-pump vs. 0.96 ± 0.1 in on-pump ( P = 0.06 ) . However , after adjusting by heparin dose , graft patency was not statistically different between groups ( OR 0.87 , 95 % CI 0.25 - 2.98 , P = 0.83 ) . At 30 days , there was no statistically significant difference in major adverse events and neuropsychological functioning between off-pump and on-pump groups . One-year follow-up showed similar functional class and positive treadmill exercise tests . CONCLUSIONS Under the conditions this trial was conducted , CABG performed off-pump had lower overall graft patency rate than on-pump , which was not statistically different after controlling for total heparin dose . Thirty-day complications , neuropsychological functioning , and one-year clinical and functional outcomes were not statistically different between the two techniques OBJECTIVE Cardiopulmonary bypass ( CPB ) is associated with gut mucosal hypoxia , which may contribute to gastrointestinal complications . We examined gastric mucosal oxygenation together with whole-body oxygen flux in low-risk patients undergoing coronary artery bypass grafting ( CABG ) with and without CPB . METHODS Fifty-four patients undergoing primary CABG by the same surgeon were r and omized into either on-pump ( ONCAB , n=27 ) or off-pump ( OPCAB , n=27 ) groups . The ONCAB group underwent mild hypothermic ( 35 degrees C ) pulsatile CPB with arterial line filtration . Each patient underwent perioperative monitoring with continuous tonometry and cardiac output devices . Gastric intramucosal pH ( pHi ) , gastric-arterial carbon dioxide partial pressure difference ( CO(2 ) gap ) , whole-body oxygen delivery ( DO(2 ) ) and consumption ( VO(2 ) ) and whole-body oxygen extraction fraction were measured at sequential time-points intraoperatively and up to 6 h postoperatively . Anaesthetic management was st and ardized . RESULTS Both groups had similar demographic makeup and extent of revascularization ( ONCAB 2.6+/-0.9 grafts versus OPCAB 2.5+/-0.8 grafts ; P=0.55 ) . The ONCAB group had a mean ( + /-SD ) CPB time of 62+/-25 min and aortic cross-clamp time of 32+/-11 min . In both groups there was a similar and progressive drop in pHi intraoperatively . Postoperatively , there was a gradual separation between the groups with ONCAB patients showing no further decline in pHi , while further deterioration was observed in the OPCAB group up to 6 h postoperatively . There was a significant difference between the groups over time ( P=0.03 ) . There was a corresponding progressive rise in CO(2 ) gap perioperatively in both groups , with ONCAB patients demonstrating superior preservation of gastric mucosal oxygenation in the early postoperative period . Global oxygen utilization measurements showed superior DO(2 ) and VO(2 ) in the OPCAB group throughout the study . CONCLUSIONS Despite superior global oxygen flux associated with beating-heart revascularization , gastric mucosal hypoxia occurred to similar extents in both groups with worsening trends for the OPCAB patients postoperatively . The splanchnic pathophysiology during beating-heart revascularization should be further explored BACKGROUND Coronary artery bypass surgery with cardiopulmonary bypass carries a significant risk of perioperative brain injury . At least 1 % to 5 % will suffer a stroke , and at 3-months postoperatively approximately 30 % are reported to have cognitive impairment assessed by neuropsychologic testing . In off-pump surgery cardiopulmonary bypass is not used and instrumentation on the ascending aorta is reduced . The main aim of this study was to assess if off-pump surgery reduces intraoperative cerebral embolization . METHODS This was a prospect i ve and r and omized study of two comparable groups with regard to age , sex , years of education , preoperative cognitive functioning , and surgical characteristics . Fifty-two patients ( 29 off-pump ) were monitored by the use of transcranial Doppler ultrasound for cerebral microembolization during surgery . Preoperative and postoperative clinical , cerebral magnetic resonance imaging , and neuropsychologic examinations were also carried out . RESULTS There was a significant reduction in the number of cerebral microemboli during off-pump compared with on-pump surgery ( 16.3 [ range 0 to 131 ] versus 90.0 [ range 15 to 274 ] , p < 0.0001 ) . No significant difference with regard to the incidence of neuropsychologic performance ( decline in 29 % off-pump , 35 % on-pump ) or neuroradiologic findings at 3 months was found , and there was no association between the number of cerebral microemboli and cognitive outcome . CONCLUSIONS This study clearly demonstrates that off-pump surgery leads to a reduction in intraoperative cerebral microembolization . A significant reduction in the number of off-pump patients with cognitive decline or ischemic brain lesions on cerebral magnetic resonance imaging could not be demonstrated in this relatively small patient population OBJECTIVE Age is considered to be the strongest predictive factor of postoperative cognitive dysfunction ( POCD ) after cardiac surgery . Coronary artery bypass grafting ( CABG ) without the use of cardiopulmonary bypass is considered to be less harmful to the patient , especially in terms of neurological complications . METHODS The study was a sub- study of the r and omized best bypass surgery trial that compares off-pump to on-pump treatment , with respect to peri- and postoperative morbidity in patients with a moderate to high-predicted preoperative risk . We investigated cognitive outcomes . A total of 120 elderly patients ( mean age 76 years , SD 4.5 years ) underwent cognitive testing before surgery , of which 90 patients ( 47 vs 43 ) were available for retesting at 1 year ( mean 370 days ) postoperatively , using a neuropsychological test battery that included seven parameters from four tests . POCD was defined as the occurrence of at least two deficits out of the seven possible scores . Secondary analysis was performed based on definition of 20 % decline in cognitive scores compared to baseline , and using z-score analysis . RESULTS The incidence of POCD was 19 % ( 95 % CI 9 - 33 ) in the off-pump group and 9 % ( 95 % CI 3 - 22 ) in the on-pump group ( p=0.18 ) . There were no significant differences in the incidence of cognitive decline between the off-pump and on-pump group regardless of the definition applied . CONCLUSIONS We were unable to detect that CABG surgery without cardiopulmonary bypass was associated with significantly better cognitive outcome in elderly high-risk patients 1 year after the operation BACKGROUND The development of new surgical devices and techniques allows off pump coronary artery bypass grafting ( OPCAB ) without the use of CPB and cardioplegia . This study tested whether OPCAB reduces myocardial cell damage , lipid peroxidation and systemic endothelin release when compared to conventional coronary artery bypass grafting . METHODS Twenty-six patients were assigned to either the OPCAB procedure using a suction device and regular sternotomy ( n = 13 ) or were treated conventionally using extracorporeal circulation , blood cardioplegia and hypothermic arrest ( 29 - 31 degrees C ; n = 13 ) . Troponin I and creatine kinase - MB were determined for cardiac specific cell damage . Myocardial and systemic malondialdhyde levels were measured to account for oxyradical mediated lipid peroxidation . Systemic big-endothelin levels were determined as a marker for
Output:
| Our systematic review did not demonstrate any significant benefit of off-pump compared with on-pump CABG regarding mortality , stroke , or myocardial infa rct ion .
In contrast , we observed better long-term survival in the group of patients undergoing on-pump CABG with the use of cardiopulmonary bypass and cardioplegic arrest .
Based on the current evidence , on-pump CABG should continue to be the st and ard surgical treatment .
However , off-pump CABG may be acceptable when there are contraindications for cannulation of the aorta and cardiopulmonary bypass . |
MS213198 | ***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: STUDY OBJECTIVE To assess the ability of endobronchial ultrasonography ( EBUS ) using a guide sheath ( EBUS-GS ) to diagnose peripheral pulmonary lesions . METHOD We devised a technique for EBUS-GS covering a miniature probe , and 150 lesions were evaluated in a prospect i ve open study . In this procedure , the probe covered by a guide sheath is introduced into the lesion via the working channel of a bronchoscope . The probe is withdrawn , while the guide sheath is left in situ . A brush or biopsy forceps is introduced through the guide sheath into the lesion . RESULTS One hundred sixteen of 150 EBUS-GS procedures ( 77 % ) were diagnostic . Cases in which the probe was located within the lesion had a significantly higher diagnostic yield ( 105 of 121 cases , 87 % ) than when the probe was located adjacent to it ( 8 of 19 cases , 42 % ) [ p < 0.0001 , chi(2 ) ] . The diagnostic yield from EBUS-GS in lesions < /= 10 mm ( 16 of 21 lesions , 76 % ) , > 10 to < /= 15 mm ( 19 of 25 lesions , 76 % ; p = 0.99 , chi(2 ) ) , > 15 to < /= 20 mm ( 23 of 35 lesions , 66 % ; p = 0.41 , chi(2 ) ) , and > 20 to < /= 30 mm ( 33 of 43 lesions , 77 % ; p = 0.96 , chi(2 ) ) were similar , demonstrating the efficacy of EBUS-GS even in lesions < /= 10 mm in diameter . In 54 of 81 lesions < /= 20 mm , fluoroscopy was not able to confirm whether the forceps reached the lesion . However , the yield was the same with ( 67 % , 18 of 27 lesions ) and without ( 74 % , 40 of 54 lesions ) successful fluoroscopy ( p = 0.96 , chi(2 ) ) . Moderate bleeding occurred in two patients ( 1 % ) ; there were no other complications . CONCLUSIONS EBUS-GS is a useful method for collecting sample s from peripheral pulmonary lesions , even those too small to be visualized under fluoroscopy BACKGROUND Peripheral pulmonary lesions are technically challenging with conventional bronchoscopy in obtaining tissue diagnosis . The recently developed small-caliber ultrasonographic probe can be introduced via the working channel of a flexible bronchoscope to localize peripheral pulmonary lesions ( PPLs ) prior to transbronchial lung biopsy ( TBLB ) . The endobronchial ultrasound-guided transbronchial lung biopsy ( EBUS-TBLB ) is a new diagnostic method for the diagnosis of pulmonary lesions in our center . OBJECTIVE To evaluate the diagnostic yield of EBUS-TBLB in pulmonary lesions . STUDY DESIGN A prospect i ve cross-sectional study . MATERIAL AND METHOD We enrolled 152 patients with pulmonary lesions that were beyond the segmental bronchus and had no evidence of endobronchial lesion , who underwent bronchoscopy in our center . With EBUS assisted , transbronchial lung biopsy was performed after localizing and measuring distance from the tip of bronchoscope to the lesion . The diagnostic yield was calculated . RESULTS The pulmonary lesions were visible on EBUS image in 98.7 % of cases . The overall diagnostic yield of EBUS-TBLB was 66.4 % . The diagnostic yield in the infiltrative and mass lesions were 86.4 % and 63.1 % , respectively . The lesions which EBUS probe located within it were diagnosed by EBUS-TBLB about 74.8 % . The benign and malignant lesions were diagnosed by EBUS-TBLB about 81.1 % and 58.6 % , respectively . The average EBUS time was 3.55 + /- 2.29 minutes . No complication of EBUS and transbronchial lung biopsy were observed in this study . CONCLUSION EBUS-TBLB is a safe procedure for diagnosing pulmonary lesions . Our results indicate that the EBUS-TBLB improves the diagnostic yield compared to conventional brochoscopy PURPOSE To report results of a 5-year prospect i ve low-dose helical chest computed tomographic ( CT ) study of a cohort at high risk for lung cancer . MATERIAL S AND METHODS After informed written consent was obtained , 1520 individuals were enrolled . Protocol was approved by institutional review board and National Cancer Institute and was compliant with Health Insurance Portability and Accountability Act , or HIPAA . Participants were aged 50 years and older and had smoked for more than 20 pack-years . Participants underwent five annual ( one initial and four subsequent ) CT examinations . A significant downward shift was evaluated in non-small cell lung cancers detected initially from advanced stage down to stage I by using a one-sided binomial test of proportions . Poisson regression and Fisher exact tests were used for comparisons with Mayo Lung Project . RESULTS In 788 ( 52 % ) men and 732 ( 48 % ) women , 61 % ( 927 of 1520 ) were current smokers , and 39 % were former smokers . After five annual CT examinations , 3356 uncalcified lung nodules were identified in 1118 ( 74 % ) participants . Sixty-eight lung cancers were diagnosed ( 31 initial , 34 subsequent , three interval cancers ) in 66 participants . Twenty-eight subsequent cases of non-small cell cancers were detected , of which 17 ( 61 % ; 95 % confidence interval : 41 % , 79 % ) were stage I tumors . Diameter of cancers detected subsequently was 5 - 50 mm ( mean , 14.4 mm ; median , 10.0 mm ) . Analysis for a more than 50 % shift in proportion of stage I non-small cell cancer detection did not show statistical significance . Forty-eight participants died of various causes since enrollment . Lung cancer mortality rate for incidence portion of trial was 1.6 per 1000 person-years . There was no significant difference in lung cancer mortality rates of cancers detected in subsequent examinations between this trial and Mayo Lung Project after separation of participants into subsets ( 2.8 vs 2.0 per 1000 person-years , P = .43 ) . CONCLUSION CT allows detection of early-stage lung cancers . Benign nodule detection rate is high . Results suggest no stage shift STUDY OBJECTIVES We evaluated the feasibility and efficacy of transbronchial biopsy ( TBB ) and bronchial brushing by endobronchial ultrasonography ( EBUS ) with a guide sheath ( GS ) as a guide for diagnosing peripheral pulmonary lesions ( PPLs ) without radiographic fluoroscopy . PATIENTS One hundred twenty-one patients with 123 PPLs ( mean diameter , 31.0 mm ) whose bronchoscopic findings were normal . METHODS An EBUS-GS was inserted and advanced to the PPL without fluoroscopy . Once we obtained the EBUS image , the probe was withdrawn and the GS was left in place . TBB and /or bronchial brushing were performed via the GS . When an EBUS image could not be obtained , we changed to the bronchoscopic examination under fluoroscopy . RESULTS Seventy-six of 123 PPLs ( 61.8 % ) were diagnosed by EBUS-GS guidance without fluoroscopy . The diagnostic yield for PPLs > 20 mm in diameter ( 75.6 % ) was significantly higher than that for those < or= 20 mm in diameter ( 29.7 % ; p < 0.01 ) . The PPLs located in the middle lobe and the lingular segment had significantly higher diagnostic yields ( p < 0.05 ) . When the bronchus leading to the PPL was identified on the CT scan , the yield was 79.2 % . Moreover , the solid lesions had a higher diagnostic yield ( 67.0 % ) compared with nonsolid lesions ( 35.0 % ; p < 0.05 ) . Multivariate analysis revealed that the diameter and the location of the PPL were independent predictors of diagnostic sensitivity by EBUS-GS-guided bronchoscopy ( p < 0.05 ) . CONCLUSIONS EBUS-GS-guided bronchoscopy without the use of radiographic fluoroscopy is effective for diagnosing PPLs . The diameter , location , and CT scan appearance of the PPLs , and the identification of the bronchus leading to the PPLs were valuable as factors related to a higher diagnostic sensitivity with this procedure Transbronchial biopsy ( TBBX ) for peripheral lung lesions is usually performed with the help of fluoroscopy , but the yield varies widely . This feasibility study aim ed to assess the ability of endobronchial ultrasound ( EBUS ) to provide imaging guidance for TBBX . In a prospect i ve study , 50 consecutive patients referred for TBBX for peripheral lesions underwent fluoroscopy-guided and EBUS-guided TBBX in r and om order . Diagnostic yields were compared for both modalities and feasibility was assessed for EBUS . Diagnostic material was obtained in 80 % of patients with EBUS and 76 % of patients with fluoroscopy . There was a nonsignificant trend for EBUS to be better than fluoroscopy for lesions <3 cm in diameter . Four lesions could not be visualised with EBUS . There were no significant complications associated with the use of EBUS . Endobronchial ultrasound-guided transbronchial biopsy is feasible . It appears to be at least equivalent to fluoroscopy without the accompanying radiation exposure . Further large-scale studies are indicated to assess the possible role of endobronchial ultrasound as a potential imaging method of choice for the biopsy of peripheral lung lesions Background : Electromagnetic navigation has been approved for use as an adjunct to st and ard bronchoscopy . The diagnostic yield varies depending on the size of the lesion and successful navigation to the lesion . Objectives : The performance of two different biopsy tools , i.e. catheter aspiration and forceps biopsy , in the diagnosis of small pulmonary nodules ( SPN ) guided by electromagnetic navigational bronchoscopy ( ENB ) was examined . Methods : 54 patients referred for suspected lung cancer underwent ENB and 55 SPN ( <3 cm ) were sample d using both techniques . Endobronchial ultrasound ( EBUS ) was used to verify the accuracy of target lesion localization by ENB . Primary end points of the study were successful navigation to the lesion and a positive diagnosis . Patients were followed until a definitive diagnosis was obtained . Results : All 55 lesions were accessed . Two lesions were excluded from data analysis as the patients were lost to follow-up and their diagnoses could not be confirmed . Of the remaining 53 lesions , 40 sample s ( 75.5 % ) were diagnostic . Compared to forceps biopsy , catheter aspiration was positively correlated with the success rate ( 36/40 vs. 22/40 ; p = 0.035 ) . The diagnostic yield was 93 % when EBUS verified the lesion location after navigation and only 48 % when lesion location was not confirmed . There were no significant complications . Conclusions : ENB is a useful tool in the evaluation of SPN <3 cm in diameter . For malignant lesions , sampling by catheter aspiration is associated with a higher diagnostic yield than sampling by forceps biopsy alone , in particular when EBUS could not confirm lesion location prior to sampling The present study prospect ively evaluated the diagnostic yield and safety of electromagnetic navigation-guided bronchoscopy biopsy , for small peripheral lung lesions in patients where st and ard techniques were nondiagnostic . The study was conducted in a tertiary medical centre on 40 consecutive patients considered unsuitable for straightforward surgery or computed tomography (CT)-guided transthoracic needle aspiration biopsy , due to comorbidities . The lung lesion diameter was mean±sem 23.5±1.5 mm and the depth from the visceral-costal pleura was 14.9±2 mm . Navigation was facilitated by an electromagnetic tracking system which could detect a position sensor incorporated into a flexible catheter advanced through a bronchoscope . Information obtained during bronchoscopy was superimposed on previously acquired CT data . Divergence between CT data and data obtained during bronchoscopy was calculated by the system 's software as a measure of navigational accuracy . All but one of the target lesions was reached and the overall diagnostic yield was 62.5 % ( 25–40 ) . Diagnostic yield was significantly affected by CT-to-body divergence ; yield was 77.2 % when estimated divergence was ≤4 mm . Three pneumothoraces occurred and chest drainage was required in one case . Electromagnetic navigation-guided bronchoscopy has the potential to improve the diagnostic yield of transbronchial biopsies without additional fluoroscopic guidance , and may be useful in the early diagnosis of lung cancer , particularly in nonoperable patients Background : The aim of this study was to evaluate the diagnostic utility of endobronchial ultrasound (EBUS)-guided transbronchial biopsy ( TBB ) using a novel 3.4-mm thin bronchoscope and a 1.4-mm ultrasonic probe for peripheral pulmonary lesions . Methods : A total of 86 patients with suspected peripheral lesions were included in this prospect i ve study . EBUS-TBBs were performed using a prototype 3.4-mm thin bronchoscope
Output:
| Conclusion : Both technologies have a high proportion of successful PPL localization with similar sensitivity for malignancy and accuracy . |
MS213199 | ***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: UNLABELLED Successful treatment of chronic HCV with peginterferon ( PEGIFN ) and ribavirin ( RVN ) is often limited by anemia . We performed the present study to determine if utilizing epoetin alpha ( EPO ) with or without a higher dose of RVN could enhance sustained virologic response ( SVR ) . We r and omized 150 treatment-naive patients with chronic HCV genotype 1 into 3 treatment groups : ( 1 ) PEGIFN alpha-2b ( 1.5 microg/kg/week ) + weight-based RVN ( WBR ) 13.3 mg/kg/day ( 800 to 1400 mg/day ) ; ( 2 ) PEGIFN alpha-2b + WBRVN + EPO ( 40,000 U/week ) ; or ( 3 ) PEGIFN alpha-2b + higher dose WBR 15.2 mg/kg/day ( 1000 to 1600 mg/day ) + EPO . We initiated EPO at the onset of therapy to maintain the hemoglobin between 12 and 15 g/dL. When required , we reduced RVN by 200-mg steps . African Americans compose 36 % of the population . A significantly smaller percentage of group 2 patients had a decline in hemoglobin to less than 10 g/dL ( 9 % versus 34 % ; P < 0.05 ) and required that the RVN dose be reduced ( 10 % versus 40 % ; P < 0.05 ) compared to group 1 patients . Despite this , SVR was similar in these groups ( 19 % to 29 % ) . SVR was significantly greater ( P < 0.05 ) in group 3 patients ( 49 % ) . This result ed from a significant decline ( P < 0.05 ) in relapse rate ; only 8 % versus 38 % for groups 1 and 2 . CONCLUSION We conclude that using EPO in all subjects at the initiation of PEGIFN and RVN treatment will not enhance SVR given the same starting dose of RVN . In contrast , a higher starting dose of RVN was associated with a lower relapse rate and higher rate of SVR BACKGROUND Patients with genotype 1 hepatitis C virus ( HCV ) who do not have a sustained response to therapy with peginterferon alfa and ribavirin have a low likelihood of success with retreatment . METHODS We r and omly assigned patients with HCV genotype 1 who had not had a sustained virologic response after peginterferon alfa-ribavirin therapy to one of four treatment groups : 115 patients to the T12PR24 group , receiving telaprevir ( 1125-mg loading dose , then 750 mg every 8 hours ) for 12 weeks and peginterferon alfa-2a ( 180 microg per week ) and ribavirin ( 1000 or 1200 mg per day , according to body weight ) for 24 weeks ; 113 patients to the T24PR48 group , receiving telaprevir for 24 weeks and peginterferon alfa-2a and ribavirin for 48 weeks ( at the same doses as in the T12PR24 group ) ; 111 patients to the T24P24 group , receiving telaprevir and peginterferon alfa-2a for 24 weeks ( at the same doses as in the T12PR24 group ) ; and 114 patients to the PR48 ( or control ) group , receiving peginterferon alfa-2a and ribavirin for 48 weeks ( at the same doses as in the T12PR24 group ) . The primary end point was sustained virologic response ( undetectable HCV RNA levels 24 weeks after the last dose of study drugs ) . RESULTS The rates of sustained virologic response in the three telaprevir groups--51 % in the T12PR24 group , 53 % in the T24PR48 group , and 24 % in the T24P24 group -- were significantly higher than the rate in the control group ( 14 % ; P<0.001 , P<0.001 , and P=0.02 , respectively ) . Response rates were higher among patients who had previously had relapses than among nonresponders . One of the most common adverse events in the telaprevir groups was rash ( overall , occurring in 51 % of patients , with severe rash in 5 % ) . Discontinuation of study drugs because of adverse events was more frequent in the telaprevir groups than in the control group ( 15 % vs. 4 % ) . CONCLUSIONS In HCV-infected patients in whom initial peginterferon alfa and ribavirin treatment failed , retreatment with telaprevir in combination with peginterferon alfa-2a and ribavirin was more effective than retreatment with peginterferon alfa-2a and ribavirin alone . ( Clinical Trials.gov number , NCT00420784 . UNLABELLED Merimepodib ( MMPD ) is an orally administered , inosine monophosphate dehydrogenase inhibitor that has shown antiviral activity in nonresponders with chronic hepatitis C ( CHC ) when combined with pegylated interferon alfa 2a ( Peg-IFN-alfa-2a ) and ribavirin ( RBV ) . We conducted a r and omized , double-blind , multicenter , phase 2b study to evaluate the antiviral activity , safety , and tolerability of MMPD in combination with Peg-IFN-alfa-2a and RBV in patients with genotype 1 CHC who were nonresponders to prior therapy with Peg-IFN and RBV . Patients received 50 mg MMPD , 100 mg MMPD , or placebo every 12 hours , in addition to Peg-IFN-alfa-2a and RBV , for 24 weeks . Patients with a 2-log or more decrease from baseline or undetectable hepatitis C virus ( HCV ) RNA levels at week 24 were then eligible to continue Peg-IFN-alfa-2a and RBV for a further 24 weeks , followed by 24 weeks of follow-up . The primary efficacy endpoint was sustained virological response ( SVR ) rate at week 72 in all r and omized patients who received at least one dose of study drug and had a history of nonresponse to st and ard therapy . A total of 354 patients were r and omized to treatment ( 117 to placebo ; 119 to 50 mg MMPD ; 118 to 100 mg MMPD ) , and 286 completed the core study . The proportion of patients who achieved SVR was similar among the treatment groups : 6 % ( 6/107 ) for 50 mg MMPD , 4 % ( 5/112 ) for 100 mg MMPD , and 5 % ( 5/104 ) for placebo ( P = 0.8431 ) . Adverse-event profiles for the MMPD combination groups were similar to that for Peg-IFN-alfa and RBV alone . Nausea , arthralgia , cough , dyspnea , neutropenia , and anemia were more common in patients taking MMPD . CONCLUSION The addition of MMPD to Peg-IFN-alfa-2a and RBV combination therapy did not increase the proportion of nonresponder patients with genotype 1 CHC achieving an SVR BACKGROUND In patients with chronic infection with hepatitis C virus ( HCV ) genotype 1 , treatment with peginterferon alfa and ribavirin for 48 weeks results in rates of sustained virologic response of 40 to 50 % . Telaprevir is a specific inhibitor of the HCV serine protease and could be of value in HCV treatment . METHODS A total of 334 patients who had chronic infection with HCV genotype 1 and had not been treated previously were r and omly assigned to receive one of four treatments involving various combinations of telaprevir ( 1250 mg on day 1 , then 750 mg every 8 hours ) , peginterferon alfa-2a ( 180 microg weekly ) , and ribavirin ( dose according to body weight ) . The T12PR24 group ( 81 patients ) received telaprevir , peginterferon alfa-2a , and ribavirin for 12 weeks , followed by peginterferon alfa-2a and ribavirin for 12 more weeks . The T12PR12 group ( 82 patients ) received telaprevir , peginterferon alfa-2a , and ribavirin for 12 weeks . The T12P12 group ( 78 patients ) received telaprevir and peginterferon alfa-2a without ribavirin for 12 weeks . The PR48 ( control ) group ( 82 patients ) received peginterferon alfa-2a and ribavirin for 48 weeks . The primary end point , a sustained virologic response ( an undetectable HCV RNA level 24 weeks after the end of therapy ) , was compared between the control group and the combined T12P12 and T12PR12 groups . RESULTS The rate of sustained virologic response for the T12PR12 and T12P12 groups combined was 48 % ( 77 of 160 patients ) , as compared with 46 % ( 38 of 82 ) in the PR48 ( control ) group ( P=0.89 ) . The rate was 60 % ( 49 of 82 patients ) in the T12PR12 group ( P=0.12 for the comparison with the PR48 group ) , as compared with 36 % ( 28 of 78 patients ) in the T12P12 group ( P=0.003 ; P=0.20 for the comparison with the PR48 group ) . The rate was significantly higher in the T12PR24 group ( 69 % [ 56 of 81 patients ] ) than in the PR48 group ( P=0.004 ) . The adverse events with increased frequency in the telaprevir-based groups were pruritus , rash , and anemia . CONCLUSIONS In this phase 2 study of patients infected with HCV genotype 1 who had not been treated previously , one of the three telaprevir groups had a significantly higher rate of sustained virologic response than that with st and ard therapy . Response rates were lowest with the regimen that did not include ribavirin . ( Clinical Trials.gov number , NCT00372385 . BACKGROUND / AIMS The aim of this study was to increase virologic response rates by individualized treatment according to the early virologic response . METHODS Serum HCV-RNA was frequently quantified in patients with chronic hepatitis C ( n=270 ) treated with peginterferon alfa-2a ( 180 microg/week ) and ribavirin ( 1000 - 1200 mg/day ) . After 6 weeks patients were classified as rapid ( RVR ) , slow ( SPR ) , flat ( FPR ) , or null responders ( NUR ) and r and omized within each viral kinetic class to continue therapy either with an individualized or st and ard regimen . Individualized therapy comprised peginterferon monotherapy ( 48 weeks ) or shorter combination therapy ( 24 weeks ) for RVR , triple therapy with histamine ( 1 mg/day ) ( 48 weeks ) or prolonged combination therapy ( 72 weeks ) for SPR , triple therapy for FPR , and high-dose peginterferon ( 360 microg/week ) plus ribavirin for NUR patients . RESULTS Patients were categorized as RVR ( n=171 ) , SPR ( n=65 ) , FPR ( n=10 ) , or NUR ( n=22 ) . Overall end-of-treatment and sustained virologic response rates were 77 and 60 % in the individualized and 77 and 66 % in the st and ard treatment arm , respectively . Histamine in addition to peginterferon and ribavirin and high-dose peginterferon plus ribavirin did not improve virologic response rates in patients with FPR and NUR , respectively . CONCLUSIONS An improvement in virologic efficacy was not achieved with the available individualized treatment options This study tested the hypothesis that high‐dose peginterferon alfa‐2a ( PEG‐IFNα‐2a ) for the first 12 weeks would increase early and sustained virological response ( SVR ) rates in patients with chronic hepatitis C genotype 1 . Eight hundred ninety‐six patients were r and omized 1:1 to 360 μg ( n = 448 ) or 180 μg ( n = 448 ) PEG‐IFNα‐2a weekly plus ribavirin at 1000‐1200 mg/day for 12 weeks , followed by 36 weeks of 180 μg PEG‐IFNα‐2a weekly plus ribavirin at 1000‐1200 mg/day with 871 patients evaluable for the intention‐to‐treat analysis . Virological responses were assessed by TaqMan ( limit of detection 15 IU/mL ) at week 4 , 8 , 12 , 24 , 48 ( end of therapy ) , and 24 weeks following therapy ( SVR ) . Undetectable hepatitis C virus RNA rates were significantly higher among patients receiving high‐dose
Output:
| Conclusion The mortality rate during PEG-IFN/RBV therapy was acceptably low , but the rate of SAEs was not negligible in a treatment for a benign disease , and the rate was affected by treatment regimens |
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