human
***TASK*** the task is to summarize an input biomedical literature 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 provide information on the frequency and reasons for outcome reporting bias in clinical trials . Design Trial protocol s were compared with subsequent publication(s ) to identify any discrepancies in the outcomes reported , and telephone interviews were conducted with the respective trialists to investigate more extensively the reporting of the research and the issue of unreported outcomes . Participants Chief investigators , or lead or co authors of trials , were identified from two sources : trials published since 2002 covered in Cochrane systematic review s where at least one trial analysed was suspected of being at risk of outcome reporting bias ( issue 4 , 2006 ; issue 1 , 2007 , and issue 2 , 2007 of the Cochrane library ) ; and a r and om sample of trial reports indexed on PubMed between August 2007 and July 2008 . Setting Australia , Canada , Germany , the Netherl and s , New Zeal and , the United Kingdom , and the United States . Main outcome measures Frequency of incomplete outcome reporting — signified by outcomes that were specified in a trial ’s protocol but not fully reported in subsequent publications— and trialists ’ reasons for incomplete reporting of outcomes . Results 268 trials were identified for inclusion ( 183 from the cohort of Cochrane systematic review s and 85 from PubMed ) . Initially , 161 respective investigators responded to our requests for interview , 130 ( 81 % ) of whom agreed to be interviewed . However , failure to achieve subsequent contact , obtain a copy of the study protocol , or both meant that final interviews were conducted with 59 ( 37 % ) of the 161 trialists . Sixteen trial investigators failed to report analysed outcomes at the time of the primary publication , 17 trialists collected outcome data that were subsequently not analysed , and five trialists did not measure a prespecified outcome over the course of the trial . In almost all trials in which prespecified outcomes had been analysed but not reported ( 15/16 , 94 % ) , this under-reporting result ed in bias . In nearly a quarter of trials in which prespecified outcomes had been measured but not analysed ( 4/17 , 24 % ) , the “ direction ” of the main findings influenced the investigators ’ decision not to analyse the remaining data collected . In 14 ( 67 % ) of the 21 r and omly selected PubMed trials , there was at least one unreported efficacy or harm outcome . More than a quarter ( 6/21 , 29 % ) of these trials were found to have displayed outcome reporting bias . Conclusion The prevalence of incomplete outcome reporting is high . Trialists seemed generally unaware of the implication s for the evidence base of not reporting all outcomes and protocol changes . A general lack of consensus regarding the choice of outcomes in particular clinical setting s was evident and affects trial design , conduct , analysis , and reporting The aim of the study was to evaluate the effects of the use of progressive muscle relaxation training ( PMRT ) on anxiety and quality of life in colorectal cancer patients after stoma surgery . A r and omised controlled trial was used with repeated measures assessment over 10 weeks post-stoma surgery . Fifty-nine patients participated in the study and were r and omised to a  control group receiving routine care ( n=30 ) and an  experimental group receiving routine care and PMRT  through  two teaching sessions and practice at home for the first 10 weeks . The State-Trait Anxiety Inventory and two Quality of Life Scales were used to collect the data of interest in three occasions , namely during hospitalisation , at week 5 and at week 10 post-surgery . The use of PMRT significantly decreased state anxiety and improved generic quality of life in the experimental group ( P<0.05 ) , especially in the domains of physical health , psychological health , social concerns and environment . Social relationships decreased in both groups . In relation to the disease-specific quality of life measure , differences were observed only in the 10-week assessment , with the experimental group reporting better quality of life at 10 weeks , but not over time as compared to the control group . The use of PMRT should be incorporated in the long-term care of colorectal cancer patients , as it can improve their psychological health and quality of life . This may be a cost-effective intervention that needs minimal training and could easily be offered to those patients that they would like to use it as part of the specialist care provided to stoma patients AIM This paper is a report of a study to describe the efficacy of cognitive behavioural therapy for insomnia on fatigue , mood and quality of life in breast cancer survivors . BACKGROUND Women who receive primary treatment for breast cancer often complain of insomnia . Rarely evaluated in insomnia intervention studies is the effect of cognitive behavioural treatment on the psychosocial outcomes of fatigue , mood and quality of life . METHOD Data were collected between December 2002 and March 2004 with 72 women who were at least 3 months post-completion of primary treatment without current evidence of disease . Women were r and omly assigned to either the cognitive behavioural therapy for insomnia group , which received stimulus control instructions , sleep restriction therapy and sleep education and hygiene , or the component control group which received sleep education and hygiene only . The 10-week study consisted of 2 weeks of pre-treatment , 6 weeks of treatment and 2 weeks of post-treatment . Fatigue , mood and quality of life were measured at pre- and post-treatment . FINDINGS Women receiving cognitive behavioural therapy for insomnia had significant improvements in fatigue , trait anxiety , depression and quality of life . The component control group also had statistically significant increases in quality of life , with a trend suggestive of lower depression at post-treatment . CONCLUSION Globally , as the number of survivors in this population continues to grow , it is imperative that nurses continue testing interventions that may positively affect quality of life and the commonly experienced symptoms of fatigue , anxiety and depression BACKGROUND Major depressive disorder severely impairs the quality of life of patients with medical disorders such as cancer , but evidence to guide its management is scarce . We aim ed to assess the efficacy and cost of a nurse-delivered complex intervention that was design ed to treat major depressive disorder in patients who have cancer . METHODS We did a r and omised trial in a regional cancer centre in Scotl and , UK . 200 out patients who had cancer with a prognosis of greater than 6 months and major depressive disorder ( identified by screening ) were eligible and agreed to take part . Their mean age was 56.6 ( SD 11.9 ) years , and 141 ( 71 % ) were women . We r and omly assigned 99 of these participants to usual care , and 101 to usual care plus the intervention , with minimisation for sex , age , diagnosis , and extent of disease . The intervention was delivered by a cancer nurse at the centre over an average of seven sessions . The primary outcome was the difference in mean score on the self-reported Symptom Checklist-20 depression scale ( range 0 to 4 ) at 3 months after r and omisation . Analysis was by intention to treat . This trial is registered as IS RCT N84767225 . FINDINGS Primary outcome data were missing for four patients . For 196 patients for whom we had data at 3 months , the adjusted difference in mean Symptom Checklist-20 depression score , between those who received the intervention and those who did not , was 0.34 ( 95 % CI 0.13 - 0.55 ) . This treatment effect was sustained at 6 and 12 months . The intervention also improved anxiety and fatigue but not pain or physical functioning . It cost an additional pound sterling 5278 ( US$ 10 556 ) per quality -adjusted life-year gained . INTERPRETATION The intervention-Depression Care for People with Cancer-offers a model for the management of major depressive disorder in patients with cancer and other medical disorders who are attending specialist medical services that is feasible , acceptable , and potentially cost effective 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 . A propos du traitement de la detresse psychosociale chez les patients atteints de cancer : l'entrainement aux aptitudes a faire face a une situation fut trouve plus efficace que le groupe de therapie de OBJECTIVE --To determine the effect of adjuvant psychological therapy on the quality of life of patients with cancer . DESIGN -- Prospect i ve r and omised controlled trial comparing the quality of life of patients receiving psychological therapy  with that of patients receiving no therapy  , measured before therapy , at eight weeks , and at four months of follow up . SETTING --CRC Psychological Medicine Group of Royal Marsden Hospital . PATIENTS --174 patients aged 18 - 74 attending hospital with a confirmed diagnosis of malignant disease , a life expectancy of at least 12 months , or scores on various measures of psychological morbidity above previously defined cut off points . INTERVENTION -- Adjuvant psychological therapy , a brief , problem focused , cognitive-behavioural treatment programme specifically design ed for the needs of individual cancer patients . MAIN OUTCOME MEASURES --Hospital anxiety and depression scale , mental adjustment to cancer scale , Rotterdam symptom checklist , psychosocial adjustment to illness scale . RESULTS --156 ( 90 % ) patients completed the eight week trial ; follow up data at four months were obtained for 137 patients ( 79 % ) . At eight weeks , patients receiving therapy had significantly higher scores than control patients on fighting spirit and significantly lower scores on helplessness , anxious preoccupation , and fatalism ; anxiety ; psychological symptoms ; and on orientation towards health care . These differences indicated improvement in each case . At four months , patients receiving therapy had significantly lower scores than controls on anxiety ; psychological symptoms ; and psychological distress . Clinical ly , the proportion of severely anxious patients dropped from 46 % at baseline to 20 % at eight weeks and 20 % at four months in the therapy group and from 48 % to 41 % and to 43 % respectively among controls . The proportion of patients with depression was 40 % at baseline , 13 % at eight weeks , and 18 % at four months in the therapy group and 30 % , 29 % , and 23 % respectively in controls . CONCLUSIONS --Adjuvant psychological therapy produces significant improvement in various measures of psychological distress among cancer patients . The effect of therapy observed at eight weeks persists in some but not all measures at four month follow up PURPOSE Chronic insomnia is highly prevalent in cancer patients .  Cognitive-behavioral therapy ( CBT ) is considered the treatment of choice for chronic primary insomnia . However , no r and omized controlled study has been conducted on its efficacy for  insomnia secondary to cancer . Using a r and omized controlled design , this study conducted among breast cancer survivors evaluated the effect of CBT on sleep , assessed both subjectively and objective ly , and on hypnotic medication use , psychological distress , and quality of life . PATIENTS AND METHODS Fifty-seven women with insomnia caused or aggravated by breast cancer were r and omly assigned to CBT ( n = 27 ) or a waiting-list control condition ( n = 30 ) . The treatment consisted of eight weekly sessions administered in a group and combined the use of stimulus control , sleep restriction , cognitive therapy , sleep hygiene , and fatigue management . Follow-up evaluations were carried out 3 , 6 , and 12 months after the treatment . RESULTS Participants who received the insomnia treatment had significantly better subjective sleep indices ( daily sleep diary , Insomnia Severity Index ) , a lower frequency of medicated nights , lower levels of depression and anxiety , and greater global quality of life at post-treatment compared with participants of the control group after their waiting period . Results were more equivocal on polysomnographic indices . Therapeutic effects were well maintained up to 12 months after the intervention and generally were clinical ly significant . CONCLUSION This study supports the efficacy of CBT for insomnia secondary to breast cancer Eighteen patients who had undergone stoma surgery were assessed with respect to their anxiety level and self-reported quality of life ( QoL ) on three occasions ; namely , immediately after surgery , 5 weeks after surgery , and 10 weeks after surgery . The patients were r and omised into a control group ( n = 10 ) and an experimental group ( n = 8) . A 20-min set of audiotaped instructions on progressive muscle relaxation training ( PMRT ) was given to the patients in the experimental group for home practice . Assessment instructions included the Chinese State-Trait Anxiety Inventory ( C-STAI ) , the Quality of Life Index for Colostomy ( QoL-Colostomy ) and the Hong Kong Chinese version of the World Health Organisation Quality of Life Scale ( WHOQoL ) . Results indicated that there was a significant decrease in both the C-STAI score ( F = 4.66 , P < 0.05 ) and the WHOQoL score ( F = 4.74 , P < 0.05 ) in the experimental group . Among the domains of WHOQoL , a significant difference was shown in physical health/independence and general perception of QoL , with the experimental group demonstrating better functioning . For the QoL-Colostomy , however , there was no significant difference between the control and experimental groups . The results suggest that the use of PMRT could enhance quality of life and decrease state anxiety in patients after stoma surgery The efficacy of problem-solving therapy ( PST ) to reduce psychological distress was assessed among a sample of 132 adult cancer patients . A second condition provided PST for both the patient and a significant other . At posttreatment , all participants receiving PST fared significantly better than waiting list control patients . Further , improvements in problem solving were found to correlate significantly with improvements in psychological distress and overall quality of life . No differences in symptom reduction were identified between the 2 treatment protocol s. At a 6-month follow- 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature 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 provide information on the frequency and reasons for outcome reporting bias in clinical trials . Design Trial protocol s were compared with subsequent publication(s ) to identify any discrepancies in the outcomes reported , and telephone interviews were conducted with the respective trialists to investigate more extensively the reporting of the research and the issue of unreported outcomes . Participants Chief investigators , or lead or co authors of trials , were identified from two sources : trials published since 2002 covered in Cochrane systematic review s where at least one trial analysed was suspected of being at risk of outcome reporting bias ( issue 4 , 2006 ; issue 1 , 2007 , and issue 2 , 2007 of the Cochrane library ) ; and a r and om sample of trial reports indexed on PubMed between August 2007 and July 2008 . Setting Australia , Canada , Germany , the Netherl and s , New Zeal and , the United Kingdom , and the United States . Main outcome measures Frequency of incomplete outcome reporting — signified by outcomes that were specified in a trial ’s protocol but not fully reported in subsequent publications— and trialists ’ reasons for incomplete reporting of outcomes . Results 268 trials were identified for inclusion ( 183 from the cohort of Cochrane systematic review s and 85 from PubMed ) . Initially , 161 respective investigators responded to our requests for interview , 130 ( 81 % ) of whom agreed to be interviewed . However , failure to achieve subsequent contact , obtain a copy of the study protocol , or both meant that final interviews were conducted with 59 ( 37 % ) of the 161 trialists . Sixteen trial investigators failed to report analysed outcomes at the time of the primary publication , 17 trialists collected outcome data that were subsequently not analysed , and five trialists did not measure a prespecified outcome over the course of the trial . In almost all trials in which prespecified outcomes had been analysed but not reported ( 15/16 , 94 % ) , this under-reporting result ed in bias . In nearly a quarter of trials in which prespecified outcomes had been measured but not analysed ( 4/17 , 24 % ) , the “ direction ” of the main findings influenced the investigators ’ decision not to analyse the remaining data collected . In 14 ( 67 % ) of the 21 r and omly selected PubMed trials , there was at least one unreported efficacy or harm outcome . More than a quarter ( 6/21 , 29 % ) of these trials were found to have displayed outcome reporting bias . Conclusion The prevalence of incomplete outcome reporting is high . Trialists seemed generally unaware of the implication s for the evidence base of not reporting all outcomes and protocol changes . A general lack of consensus regarding the choice of outcomes in particular clinical setting s was evident and affects trial design , conduct , analysis , and reporting The aim of the study was to evaluate the effects of the use of progressive muscle relaxation training ( PMRT ) on anxiety and quality of life in colorectal cancer patients after stoma surgery . A r and omised controlled trial was used with repeated measures assessment over 10 weeks post-stoma surgery . Fifty-nine patients participated in the study and were r and omised to a  control group receiving routine care ( n=30 ) and an  experimental group receiving routine care and PMRT  through  two teaching sessions and practice at home for the first 10 weeks . The State-Trait Anxiety Inventory and two Quality of Life Scales were used to collect the data of interest in three occasions , namely during hospitalisation , at week 5 and at week 10 post-surgery . The use of PMRT significantly decreased state anxiety and improved generic quality of life in the experimental group ( P<0.05 ) , especially in the domains of physical health , psychological health , social concerns and environment . Social relationships decreased in both groups . In relation to the disease-specific quality of life measure , differences were observed only in the 10-week assessment , with the experimental group reporting better quality of life at 10 weeks , but not over time as compared to the control group . The use of PMRT should be incorporated in the long-term care of colorectal cancer patients , as it can improve their psychological health and quality of life . This may be a cost-effective intervention that needs minimal training and could easily be offered to those patients that they would like to use it as part of the specialist care provided to stoma patients AIM This paper is a report of a study to describe the efficacy of cognitive behavioural therapy for insomnia on fatigue , mood and quality of life in breast cancer survivors . BACKGROUND Women who receive primary treatment for breast cancer often complain of insomnia . Rarely evaluated in insomnia intervention studies is the effect of cognitive behavioural treatment on the psychosocial outcomes of fatigue , mood and quality of life . METHOD Data were collected between December 2002 and March 2004 with 72 women who were at least 3 months post-completion of primary treatment without current evidence of disease . Women were r and omly assigned to either the cognitive behavioural therapy for insomnia group , which received stimulus control instructions , sleep restriction therapy and sleep education and hygiene , or the component control group which received sleep education and hygiene only . The 10-week study consisted of 2 weeks of pre-treatment , 6 weeks of treatment and 2 weeks of post-treatment . Fatigue , mood and quality of life were measured at pre- and post-treatment . FINDINGS Women receiving cognitive behavioural therapy for insomnia had significant improvements in fatigue , trait anxiety , depression and quality of life . The component control group also had statistically significant increases in quality of life , with a trend suggestive of lower depression at post-treatment . CONCLUSION Globally , as the number of survivors in this population continues to grow , it is imperative that nurses continue testing interventions that may positively affect quality of life and the commonly experienced symptoms of fatigue , anxiety and depression BACKGROUND Major depressive disorder severely impairs the quality of life of patients with medical disorders such as cancer , but evidence to guide its management is scarce . We aim ed to assess the efficacy and cost of a nurse-delivered complex intervention that was design ed to treat major depressive disorder in patients who have cancer . METHODS We did a r and omised trial in a regional cancer centre in Scotl and , UK . 200 out patients who had cancer with a prognosis of greater than 6 months and major depressive disorder ( identified by screening ) were eligible and agreed to take part . Their mean age was 56.6 ( SD 11.9 ) years , and 141 ( 71 % ) were women . We r and omly assigned 99 of these participants to usual care , and 101 to usual care plus the intervention , with minimisation for sex , age , diagnosis , and extent of disease . The intervention was delivered by a cancer nurse at the centre over an average of seven sessions . The primary outcome was the difference in mean score on the self-reported Symptom Checklist-20 depression scale ( range 0 to 4 ) at 3 months after r and omisation . Analysis was by intention to treat . This trial is registered as IS RCT N84767225 . FINDINGS Primary outcome data were missing for four patients . For 196 patients for whom we had data at 3 months , the adjusted difference in mean Symptom Checklist-20 depression score , between those who received the intervention and those who did not , was 0.34 ( 95 % CI 0.13 - 0.55 ) . This treatment effect was sustained at 6 and 12 months . The intervention also improved anxiety and fatigue but not pain or physical functioning . It cost an additional pound sterling 5278 ( US$ 10 556 ) per quality -adjusted life-year gained . INTERPRETATION The intervention-Depression Care for People with Cancer-offers a model for the management of major depressive disorder in patients with cancer and other medical disorders who are attending specialist medical services that is feasible , acceptable , and potentially cost effective 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 . A propos du traitement de la detresse psychosociale chez les patients atteints de cancer : l'entrainement aux aptitudes a faire face a une situation fut trouve plus efficace que le groupe de therapie de OBJECTIVE --To determine the effect of adjuvant psychological therapy on the quality of life of patients with cancer . DESIGN -- Prospect i ve r and omised controlled trial comparing the quality of life of patients receiving psychological therapy  with that of patients receiving no therapy  , measured before therapy , at eight weeks , and at four months of follow up . SETTING --CRC Psychological Medicine Group of Royal Marsden Hospital . PATIENTS --174 patients aged 18 - 74 attending hospital with a confirmed diagnosis of malignant disease , a life expectancy of at least 12 months , or scores on various measures of psychological morbidity above previously defined cut off points . INTERVENTION -- Adjuvant psychological therapy , a brief , problem focused , cognitive-behavioural treatment programme specifically design ed for the needs of individual cancer patients . MAIN OUTCOME MEASURES --Hospital anxiety and depression scale , mental adjustment to cancer scale , Rotterdam symptom checklist , psychosocial adjustment to illness scale . RESULTS --156 ( 90 % ) patients completed the eight week trial ; follow up data at four months were obtained for 137 patients ( 79 % ) . At eight weeks , patients receiving therapy had significantly higher scores than control patients on fighting spirit and significantly lower scores on helplessness , anxious preoccupation , and fatalism ; anxiety ; psychological symptoms ; and on orientation towards health care . These differences indicated improvement in each case . At four months , patients receiving therapy had significantly lower scores than controls on anxiety ; psychological symptoms ; and psychological distress . Clinical ly , the proportion of severely anxious patients dropped from 46 % at baseline to 20 % at eight weeks and 20 % at four months in the therapy group and from 48 % to 41 % and to 43 % respectively among controls . The proportion of patients with depression was 40 % at baseline , 13 % at eight weeks , and 18 % at four months in the therapy group and 30 % , 29 % , and 23 % respectively in controls . CONCLUSIONS --Adjuvant psychological therapy produces significant improvement in various measures of psychological distress among cancer patients . The effect of therapy observed at eight weeks persists in some but not all measures at four month follow up PURPOSE Chronic insomnia is highly prevalent in cancer patients .  Cognitive-behavioral therapy ( CBT ) is considered the treatment of choice for chronic primary insomnia . However , no r and omized controlled study has been conducted on its efficacy for  insomnia secondary to cancer . Using a r and omized controlled design , this study conducted among breast cancer survivors evaluated the effect of CBT on sleep , assessed both subjectively and objective ly , and on hypnotic medication use , psychological distress , and quality of life . PATIENTS AND METHODS Fifty-seven women with insomnia caused or aggravated by breast cancer were r and omly assigned to CBT ( n = 27 ) or a waiting-list control condition ( n = 30 ) . The treatment consisted of eight weekly sessions administered in a group and combined the use of stimulus control , sleep restriction , cognitive therapy , sleep hygiene , and fatigue management . Follow-up evaluations were carried out 3 , 6 , and 12 months after the treatment . RESULTS Participants who received the insomnia treatment had significantly better subjective sleep indices ( daily sleep diary , Insomnia Severity Index ) , a lower frequency of medicated nights , lower levels of depression and anxiety , and greater global quality of life at post-treatment compared with participants of the control group after their waiting period . Results were more equivocal on polysomnographic indices . Therapeutic effects were well maintained up to 12 months after the intervention and generally were clinical ly significant . CONCLUSION This study supports the efficacy of CBT for insomnia secondary to breast cancer Eighteen patients who had undergone stoma surgery were assessed with respect to their anxiety level and self-reported quality of life ( QoL ) on three occasions ; namely , immediately after surgery , 5 weeks after surgery , and 10 weeks after surgery . The patients were r and omised into a control group ( n = 10 ) and an experimental group ( n = 8) . A 20-min set of audiotaped instructions on progressive muscle relaxation training ( PMRT ) was given to the patients in the experimental group for home practice . Assessment instructions included the Chinese State-Trait Anxiety Inventory ( C-STAI ) , the Quality of Life Index for Colostomy ( QoL-Colostomy ) and the Hong Kong Chinese version of the World Health Organisation Quality of Life Scale ( WHOQoL ) . Results indicated that there was a significant decrease in both the C-STAI score ( F = 4.66 , P < 0.05 ) and the WHOQoL score ( F = 4.74 , P < 0.05 ) in the experimental group . Among the domains of WHOQoL , a significant difference was shown in physical health/independence and general perception of QoL , with the experimental group demonstrating better functioning . For the QoL-Colostomy , however , there was no significant difference between the control and experimental groups . The results suggest that the use of PMRT could enhance quality of life and decrease state anxiety in patients after stoma surgery The efficacy of problem-solving therapy ( PST ) to reduce psychological distress was assessed among a sample of 132 adult cancer patients . A second condition provided PST for both the patient and a significant other . At posttreatment , all participants receiving PST fared significantly better than waiting list control patients . Further , improvements in problem solving were found to correlate significantly with improvements in psychological distress and overall quality of life . No differences in symptom reduction were identified between the 2 treatment protocol s. At a 6-month follow- 
    Output:
    