***TASK*** the task is to summarize an input biomedical literature 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 examine the effect of weekly completion of a patient-held  quality -of-life ( QOL ) diary in routine oncology practice for palliative care patients . PATIENTS AND METHODS In a pragmatic r and omized controlled trial , 115 patients with inoperable lung cancer were r and omly assigned to receive either st and ard care or a structured QOL diary ( European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 and the related lung cancer module LC13 ) that they completed at home each week for 16 weeks . Patients were encouraged to share the QOL information with health professionals involved in their care . Changes in QOL over time ( measured by the Functional Assessment of Cancer Therapy-Lung question naire and the Palliative Care Quality of Life Index ) , discussion of patient problems , and satisfaction with communication and general care were assessed at baseline and at 2 and 4 months after baseline . RESULTS Analysis of QOL indicated a small but consistent difference between patients in the diary group and the st and ard care group . The diary group had a poorer QOL in many domains . Two different QOL summary scores ( total and overall QOL ) indicated a statistically significant between-group difference . No effects were found in relation to satisfaction with care , communication , or the discussion of patient problems . CONCLUSION The regular completion of a QOL question naire without appropriate feedback to health care professionals and without the provision of appropriate support may have a negative impact on inoperable lung cancer patients . Further research should focus on identifying features such as feedback loops that are required for the successful and meaningful use of QOL question naires in routine patient care Background This study assessed the effectiveness of computerized measurement and feedback of health-related quality of life ( HRQoL ) in daily clinical practice in patients with chronic liver disease . Methods One hundred and sixty-two patients ( 61 % men ; mean age 47.5 years ) regularly completed computerized HRQoL question naires before each consultation for the duration of 1 year . Six physicians were r and omly assigned to the experimental group and received an instant online graphical output of data . Five other physicians were r and omly assigned to the control group and conducted their consultations as usual . Differences between groups on generic- and disease-specific HRQoL , patient management , and patient satisfaction with the consultation were assessed , as were physicians ’ experiences with HRQoL data and effects on their consultations . Results No direct effect of the experimental condition on patients ’ HRQoL was found . However , an interaction effect of the experimental condition and age was found : older patients in the experimental group had significantly better disease-specific HRQoL ( F = 4.16 ; P = 0.04 ) and generic mental HRQoL ( F = 4.62 ; P = 0.03 ) than patients in the control group . Also , male patients in the experimental group had better generic mental HRQoL than patients in the control group ( F = 6.10 ; P = 0.02 ) . Physicians in the experimental group altered their treatment policy significantly more often than did physicians in the control group ( z = −3.73 , P = 0.00 ) , and their experiences with the availability of HRQoL information were generally positive . The scores on patient satisfaction with the consultation did not differ significantly between the experimental and control groups ( z = −1.20 , P = 0.23 ) . Conclusions Computerized measurement and feedback of HRQoL  in a daily clinical practice of an outpatient department of hepatology did not improve HRQoL for the entire group of chronic liver patients but , rather , improved disease-specific HRQoL of older patients with chronic liver disease and mental HRQoL of older patients and male patients with chronic liver disease . It also had an effect on patient 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 Statistical tests help distinguish true differences ( associations ) from chance and result in a P value which is an estimation of probability that the results are due to chance . An arbitrary test threshold value ( eg , usually alpha = .05 ) is used to distinguish results that are assumed to be due to chance from the results that are due to other factors . The bottom line : If the probability that the results are due to chance is less than the threshold value ( P < .05 ) , it is assumed the differences are due to these other factors ( eg , true differences in treatment effects ) . However , we may be wrong 5 % of the time . Significance testing in itself does not take into account factors which may bias study results . The possible exception to this is multivariate analysis , which is a subject for future articles . Sample size and r and om variation play an important role in whether a result is statistically significant or not and , together with expected effect size , whether the study is “ powered ” to detect statistical differences . A statistically significant result does not “ prove ” anything and does not establish a causal relationship between the exposure and outcome . The finding of an “ association ” does not mean that the association is causal in most instances . This is a topic for future articles . Although a result may be statistically significant , the effect size ( ie , magnitude of the effect ) may not be biologically or clinical ly important . In critiquing , design ing , and reporting studies , the minimal clinical ly important difference is important to consider . While statistical testing is an important part of research analysis , its limitations , uses , and misuses need to be considered in order to put results of a study in the proper context . In the next issue , we tackle the topic of confounding , an important source of potential bias which needs to be considered in all studies regardless of design PURPOSE Although patient-reported cancer symptoms and quality -of-life issues ( SQLIs ) have been promoted as essential to a comprehensive assessment , efficient and efficacious methods have not been widely tested in clinical setting s. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment -Cancer ( ESRA-C ) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits . Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians . PATIENTS AND METHODS This r and omized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center .  Patient-reported SQLIs  were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit ( n = 327 ) ; in the control group , no summary was provided ( n = 333 ) . SQLIs were scored for level of severity or distress . One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI . We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians . RESULTS The likelihood of SQLIs being discussed differed by r and omized group and depended on whether an SQLI was first reported as problematic ( P = .032 ) . Clinic visits were similar with regard to duration between groups , and clinicians reported the summary as useful . CONCLUSION The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US r and omized clinical trial Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more PURPOSE This study aim ed to determine whether feeding back patient-reported outcomes ( PROs ) to providers and families of children with advanced cancer improves symptom distress and health-related quality of life ( HRQoL ) . PATIENTS AND METHODS This study was a parallel , multicentered pilot r and omized controlled trial . At most once per week , children age ≥ 2 years old with advanced cancer or their parent completed the  computer-based Pediatric Quality of Life and Evaluation of Symptoms Technology ( PediQUEST ) survey consisting of age- and respondent-adapted versions of the Memorial Symptom Assessment Scale ( MSAS ) , Pediatric Quality of Life Inventory 4.0 Generic Core Scales ( PedsQL4.0 ) , and an  overall Sickness question  . In the intervention group ( n = 51 ) , oncologists and families received printed reports summarizing PROs ; e-mails were sent to oncologists and subspecialists when predetermined scores were exceeded . No feedback was provided in the control  group ( n = 53 ) . Primary outcomes included linear trends of MSAS , PedsQL4.0 total and subscale scores , and Sickness scores during 20 weeks of follow-up , along with child , parent , and provider satisfaction with PediQUEST feedback . RESULTS Feedback did not significantly affect average MSAS , PedsQL4.0 , or Sickness score trends . Post hoc subgroup analyses among children age ≥ 8 years who survived 20 weeks showed that feedback improved PedsQL4.0 emotional ( + 8.1 ; 95 % CI , 1.8 to 14.4 ) and Sickness ( -8.2 ; 95 % CI , -14.2 to -2.2 ) scores . PediQUEST reports were valued by children , parents , and providers and contributed at least sometimes to physician initiation of a psychosocial consult ( 56 % ) . CONCLUSION Although routine feedback of PROs did not significantly affect the child 's symptoms or HRQoL , changes were in expected directions and improvements observed in emotional HRQoL through exploratory analyses were encouraging . Importantly , children , parents , and providers value PRO feedback The potential benefits of health-related quality of life ( HRQL ) assessment in oncology clinical practice include better detection of problems , enhanced disease and treatment monitoring and improved care . However , few empirical studies have investigated the effects of incorporating such assessment s into routine clinical care . Recent r and omized studies have reported improved detection of and communication about patients ' concerns , but few have found effects on patient HRQL or satisfaction . This study examined whether offering interpretive assistance of HRQL results would improve these patient outcomes . Two hundred and thirteen participants with metastatic breast , lung or colorectal cancer were r and omly assigned to one of three conditions : usual care ; HRQL assessment or HRQL assessment followed by a structured interview and discussion . Interviews about patients ' assessment responses were conducted by a research nurse , who then presented HRQL information to the treating nurse . HRQL and treatment satisfaction outcomes were assessed at 3 and 6 months . No significant differences were found between study conditions in HRQL or satisfaction . Results suggest that routine HRQL assessment , even with description of results , is insufficient to improve patient HRQL and satisfaction . It is suggested that positive effects may require supplementing assessment results with specific suggestions for clinical management changes PURPOSE There is growing interest to enhance symptom monitoring during routine cancer care using patient-reported outcomes , but evidence of impact on clinical outcomes is limited . METHODS We r and omly assigned patients receiving routine outpatient chemotherapy for advanced solid tumors at Memorial Sloan Kettering Cancer Center to report 12 common symptoms via tablet computers or to receive usual care consisting of symptom monitoring at the discretion of clinicians . Those with home computers received weekly e-mail prompts to report between visits . Treating physicians received symptom printouts at visits , and nurses received e-mail alerts when participants reported severe or worsening symptoms . The primary outcome was change in health-related quality of life ( HRQL ) at 6 months compared with baseline , measured by the EuroQol EQ-5D Index . Secondary endpoints included emergency room ( ER ) visits , hospitalizations , and survival . R 
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Conclusions Overall , studies that compared PROM to st and ard care either reported a positive effect or were not powered to find pre-specified differences .