***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: PURPOSE To determine the effects of breast cancer-specific print material s and step pedometers on  physical activity ( PA ) and quality of life ( QoL ) in breast cancer survivors . PATIENTS AND METHODS Breast cancer survivors ( N = 377 ) were r and omly assigned to receive one of the following : a st and ard public health recommendation for PA , previously developed breast cancer-specific PA print material s , a step pedometer , or a combination of breast cancer-specific print material s and step pedometers . The primary outcome was self-reported moderate/vigorous PA minutes per week . Secondary outcomes were QoL ( Functional Assessment of Cancer Therapy-Breast ) , fatigue , self-reported brisk walking , and objective step counts . Assessment s were conducted at baseline and postintervention ( 12 weeks ) . RESULTS Attrition was 10.3 % ( 39 of 377 ) . On the basis of linear mixed-model analyses , PA increased by 30 minutes/week in the st and ard recommendation group compared with 70 minutes/week in the print material group ( mean difference , 39 minutes/week ; 95 % CI = -10 to 89 ; d = 0.25 ; P = .117 ) , 89 minutes/week in the pedometer group ( mean difference , 59 minutes/week ; 95 % CI , 11 to 108 ; d = 0.38 ; P = .017 ) , and 87 minutes/week in the combined group ( mean difference , 57 minutes/week ; 95 % CI , 8 to 106 ; d = 0.37 ; P = .022 ) . For brisk walking minutes/week , all three intervention groups reported significantly greater increases than the st and ard recommendation group . The combined group also reported significantly improved QoL ( mean difference , 5.8 ; 95 % CI , 2.0 to 9.6 ; d = 0.33 ; P = .003 ) and reduced fatigue ( mean difference , 2.3 ; 95 % CI , 0.0 to 4.7 ; d = 0.25 ; P = .052 ) compared with the st and ard recommendation group . CONCLUSION Breast cancer-specific PA print material s and pedometers may be effective strategies for increasing PA and QoL in breast cancer survivors . A combined approach appears to be optimal . CLINICAL TRIAL REGISTRATION Clinical Trials.gov Identifier The Sickness Impact Profile ( SIP ) and the  Hospital Anxiety and Depression scale ( HAD ) were used for assessment of physical and psychosocial functioning and emotional distress in patients with small cell lung cancer ( SCLC ) receiving chemotherapy .  Treatment schedules extended over 12 months . Before treatment sixty-two patients , 36 - 80 years of age , completed the  question naires  and a selection of lung cancer symptom items . Approximately 50 % of the patients reported clinical ly significant physical dysfunction , while emotional distress was reported by 25 % and social restraints by 40 % . Self-reported overall dysfunction , as assessed by SIP total index , was clinical ly significant in 60 % of the patients . SIP physical and total indices were strongly related to WHO performance status ( grade 0 - 4 ) . The assessment was subsequently repeated every third month during the treatment period . Overall tumour response rate was 82 % . The changes of physical and psychosocial functioning , as assessed by SIP , were significantly related to tumour response , although a persistent substantial overall dysfunction was shown among 50 % of the responders after 3 months and among c. 40 % after 6 months . In addition to tumour response , pain and appetite changes correlated with the change of overall SIP in multivariate analysis , implying the importance of pain control and appetite stimulating measures for patients with advanced cancer .  Anxiety and depression , as measured by HAD , were reduced in 21 patients who completed 12 months chemotherapy , but only anxiety co-varied with tumour response . The results lend support to the use of the generic SIP and HAD as outcome measures in clinical research with SCLC patients receiving chemotherapy Breast cancer ( BC ) patients experience multiple symptoms as a result of diagnosis and treatment . While surveillance for detecting cancer recurrence is fundamental to follow-up care , managing symptoms , and promoting health behaviors are equally important . UCSF has implemented a secure online health question naire enabling BC patients to provide up date s of their health history and symptoms . We r and omly selected a sample of stage I – III BC patients ( n = 106 ) who completed a question naire before a medical oncology visit between August 2010 and January 2011 and consented to have data used for research . We conducted a chart review calculating the number of symptoms reported in the question naire , the clinic note only , and both question naire and clinic note , excluding chronic symptoms addressed previously . Self-reported data on exercise and alcohol consumption was compared to documentation of these lifestyle factors in clinic notes . Patients reported significantly more symptoms using the online question naire ( mean = 3.8 , range 0–13 ) than were documented by the provider in clinic notes ( mean = 1.8 , range 0–7 ; p < 0.001 for the difference ) . A regression plot comparing the percentage of symptoms agreed upon by the patient and provider and the percentage of symptoms addressed yields a slope of 0.56 ( 95 % CI 0.41–0.71 ) . The number of self-reported symptoms correlates with self-reported Karnofsky scale such that the number of symptoms reported by the patient increases linearly with this score until a threshold and it then plateaus ( p < 0.001 ) . Exercise behavior and alcohol consumption were reported in 100 % of the online question naires , but was documented in only 30/106 ( 28 % ) and 75/106 ( 70 % ) of charts review ed . In 19/75 ( 25 % ) charts with alcohol consumption documented , there was substantial discordance between patient and clinician reporting . Electronic data collection of BC patient-reported outcomes has a positive effect on symptom management and identification of opportunities for risk-reducing behavior change 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 OBJECTIVE The interpretation of health-related quality of life ( HRQL ) data from clinical trials can be enhanced by underst and ing the degree of change in HRQL scores that is considered meaningful . Our objectives were to combine distribution-based and two anchor-based approaches to identify minimally important differences ( MIDs ) for the 27-item Trial Outcome Index ( TOI ) , the seven-item Social Well-Being ( SWB ) subscale , and the six-item Emotional Well-being ( EWB ) subscale from the Functional Assessment of Cancer Therapy-Biological Response Modifiers ( FACT-BRM ) instrument . METHODS Distribution-based MIDs were based on the st and ard error of measurement . Anchor-based approaches utilized  patient-reported global rating of change ( GRC ) and change in physician-reported performance status rating ( PSR ) .  Correlations and weighted kappa statistics were used to assess association and agreement between the two anchors . FACT-BRM changes were evaluated for three time periods : baseline to month 1 , month 2 to month 3 , and month 5 to month 6 . RESULTS Association between GRC and change in PSR was poor . Correlation between the anchors and HRQL change scores was largest at month 1 and decreased through month 6 . Combining results from all approaches , the MIDs identified were 5 - 8 points for the TOI , 2 points for the SWB subscale , and 2 - 3 points for the EWB subscale . CONCLUSIONS We combined patient-reported estimates , physician-reported estimates , and distribution-based estimates to derive MIDs for HRQL outcomes from the FACT-BRM . These results will enable interpretation of treatment group effects in a clinical trial setting , and they can be used to estimate sample size or power when design ing future studies BACKGROUND Patient-reported outcomes ( PROs ) are essential for evaluating treatment effects on health-related quality of life and symptoms from the patient 's perspective . This study sought to evaluate the psychometric properties of the nine-item Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network Colorectal Cancer Symptom Index ( FCSI-9 ) in a metastatic colorectal cancer ( mCRC ) population . METHODS The FCSI-9 and EQ-5D were administered every 2 - 4 weeks to mCRC subjects in a phase III clinical trial . Three hundred ninety-one mCRC subjects completed the question naires at baseline and at least one follow-up assessment . Internal consistency reliability , test-retest reliability , construct validity , known groups validity , responsiveness , and the minimum important difference ( MID ) of the FCSI-9 were evaluated . RESULTS The internal consistency and test-retest reliability of the FCSI-9 were acceptable ( 0.81 and 0.76 , respectively ) . Construct validity was supported based on moderate correlations with the EQ-5D . Known groups validity was evaluated by examining the FCSI-9 scores of subjects categorized by their Eastern Cooperative Oncology Group performance status ( PS ) score . Subjects with better PS scores reported significantly higher FCSI-9 scores than those with lower PS scores at both baseline and week 8 . Responsiveness , as measured by Guyatt 's statistic , was 0.77 from baseline to week 8 and 0.60 from week 4 to week 12 . Considering all data together , the MID of the FCSI-9 is estimated to be in the range of 1.5 - 3.0 points . CONCLUSION Results provide preliminary evidence of the reliability , validity , and responsiveness of the FCSI-9 The st and ard approach for documenting symptomatic adverse events ( AEs ) in cancer clinical trials involves investigator reporting using the National Cancer Institute 's ( NCI 's ) Common Terminology Criteria for Adverse Events ( CTCAE ) . Because this approach underdetects symptomatic AEs , the NCI issued two contracts to create a patient-reported outcome ( PRO ) measurement system as a companion to the CTCAE , called the PRO-CTCAE . This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties . A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting . For each of these , a PRO-CTCAE plain language term in English and one to three items characterizing the frequency , severity , and /or activity interference of the AE were created , rendering a library of 124 PRO-CTCAE items . These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational , racial , and geographic background s. Favorable measurement properties of the items , including construct validity , reliability , responsiveness , and between-mode equivalence , were determined prospect ively in a demographically diverse population of patients receiving treatments for many different tumor types . A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing . Work is ongoing to translate the PRO-CTCAE into multiple language s and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses . It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research Data from a clinical study of 86 pancreatic cancer patients with involuntary , significant weight loss ( cachexia ) were used to explore the relationship between patient-reported outcomes ( PROs ) and survival . In all , 28 pancreatic cancer patients with cachexia were given gemcitabine ( Gemzar ) plus 3 mg/kg of infliximab ( Remicade ) , 28 were given gemcitabine 
    Output:
    
Irrespective of the method of capturing PROs or FPS , the quantified level of association between these two areas was moderate at best , providing evidence that FPS and PRO assessment s offer unique information to assist clinicians in their decision-making