***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 comparative effectiveness of treatments for prostate cancer that is detected by prostate-specific antigen ( PSA ) testing remains uncertain . METHODS We compared active monitoring , radical prostatectomy , and external-beam radiotherapy for the treatment of clinical ly localized prostate cancer . Between 1999 and 2009 , a total of 82,429 men 50 to 69 years of age received a PSA test ; 2664 received a diagnosis of localized prostate cancer , and 1643 agreed to undergo r and omization to active monitoring ( 545 men ) , surgery ( 553 ) , or radiotherapy ( 545 ) . The primary outcome was prostate-cancer mortality at a median of 10 years of follow-up . Secondary outcomes included the rates of disease progression , metastases , and all-cause deaths . RESULTS There were 17 prostate-cancer-specific deaths overall : 8 in the active-monitoring group ( 1.5 deaths per 1000 person-years ; 95 % confidence interval [ CI ] , 0.7 to 3.0 ) , 5 in the surgery group ( 0.9 per 1000 person-years ; 95 % CI , 0.4 to 2.2 ) , and 4 in the radiotherapy group ( 0.7 per 1000 person-years ; 95 % CI , 0.3 to 2.0 ) ; the difference among the groups was not significant ( P=0.48 for the overall comparison ) . In addition , no significant difference was seen among the groups in the number of deaths from any cause ( 169 deaths overall ; P=0.87 for the comparison among the three groups ) . Metastases developed in more men in the active-monitoring group ( 33 men ; 6.3 events per 1000 person-years ; 95 % CI , 4.5 to 8.8 ) than in the surgery group ( 13 men ; 2.4 per 1000 person-years ; 95 % CI , 1.4 to 4.2 ) or the radiotherapy group ( 16 men ; 3.0 per 1000 person-years ; 95 % CI , 1.9 to 4.9 ) ( P=0.004 for the overall comparison ) . Higher rates of disease progression were seen in the active-monitoring group ( 112 men ; 22.9 events per 1000 person-years ; 95 % CI , 19.0 to 27.5 ) than in the surgery group ( 46 men ; 8.9 events per 1000 person-years ; 95 % CI , 6.7 to 11.9 ) or the radiotherapy group ( 46 men ; 9.0 events per 1000 person-years ; 95 % CI , 6.7 to 12.0 ) ( P<0.001 for the overall comparison ) . CONCLUSIONS At a median of 10 years , prostate-cancer-specific mortality was low irrespective of the treatment assigned , with no significant difference among treatments . Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring . ( Funded by the National Institute for Health Research ; ProtecT Current Controlled Trials number , IS RCT N20141297 ; Clinical Trials.gov number , NCT02044172 . ) The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care The purpose of this study was to compare the quality of life ( QOL ) in patients with localized prostate cancer ( PC ) after intensity-modulated radiation therapy assisted with a fluoroscopic real-time intensity-modulated radiation therapy ( RT-IMRT ) tumor-tracking system versus the QOL after radical prostatectomy ( RP ) .  Between 2003 and 2006 , 71 patients were enrolled in this longitudinal prospect i ve study . Each patient was allowed to decide which treatment modality they would receive . Of the 71 patients , 23 patients underwent RT-IMRT , while 48 opted for RP . No patient received neo-adjuvant or adjuvant hormone therapy . The global QOL and disease-specific-QOL were evaluated before treatment and again at 1 , 3 and 5 years after treatment . There was no significant difference in the background characteristics between the two groups . The 5-year biochemical progression-free survival was 90 % in the RT-IMRT and 79 % in the RP group . In the RT-IMRT group , there was no significant deterioration of the global QOL or disease-specific QOL through 5 years post-treatment . In the RP group , the urinary function , sexual function , and sexual bother indicators significantly deteriorated after treatment . Urinary and sexual function was significantly better in the RT-IMRT group at 1 , 3 and 5 years post-treatment compared to the RP group . RT-IMRT may be a preferable treatment for localized PC because of similar efficacy to RP but better post-treatment QOL BACKGROUND Radical prostatectomy reduces mortality among men with localized prostate cancer ; however , important questions regarding long-term benefit remain . METHODS Between 1989 and 1999 , we r and omly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy and followed them through the end of 2012 . The primary end points in the Sc and inavian Prostate Cancer Group Study Number 4 ( SPCG-4 ) were death from any cause , death from prostate cancer , and the risk of metastases . Secondary end points included the initiation of and rogen-deprivation therapy . RESULTS During 23.2 years of follow-up , 200 of 347 men in the surgery group and 247 of the 348 men in the watchful-waiting group died . Of the deaths , 63 in the surgery group and 99 in the watchful-waiting group were due to prostate cancer ; the relative risk was 0.56 ( 95 % confidence interval [ CI ] , 0.41 to 0.77 ; P=0.001 ) , and the absolute difference was 11.0 percentage points ( 95 % CI , 4.5 to 17.5 ) . The number needed to treat to prevent one death was 8 . One man died after surgery in the radical-prostatectomy group . And rogen-deprivation therapy was used in fewer patients who underwent prostatectomy ( a difference of 25.0 percentage points ; 95 % CI , 17.7 to 32.3 ) . The benefit of surgery with respect to death from prostate cancer was largest in men younger than 65 years of age ( relative risk , 0.45 ) and in those with intermediate-risk prostate cancer ( relative risk , 0.38 ) . However , radical prostatectomy was associated with a reduced risk of metastases among older men ( relative risk , 0.68 ; P=0.04 ) . CONCLUSIONS Extended follow-up confirmed a substantial reduction in mortality after radical prostatectomy ; the number needed to treat to prevent one death continued to decrease when the treatment was modified according to age at diagnosis and tumor risk . A large proportion of long-term survivors in the watchful-waiting group have not required any palliative treatment . ( Funded by the Swedish Cancer Society and others . ) Objective . To evaluate long-term r and omized comparisons of patient-reported outcome of symptoms and health-related quality of life ( HRQoL ) in men with localized prostate cancer 10 years after external beam radiotherapy ( RT ) or watchful waiting ( WW ) .  Material and methods . Three-year HRQoL and specific symptoms in surviving patients recruited between 1986 and 1996 were previously evaluated in a r and omized trial ; definitive RT versus WW . Two question naires were used : the European Organization for Research and Treatment of Cancer ( EORTC ) QLQ-C30 and the Prostate Cancer Symptom Scale ( PCSS ) . The present study is a prolonged follow-up with the same cohorts . Results . Fifty-four of 72 eligible patients ( 75 % ) returned the question naires at the present follow-up . The median age was 77 years in the RT group and 78 years in the WW group . The median follow-up time from r and omization was 10 years . No differences in HRQoL or bowel symptoms were measured between the RT and WW . Cognitive ( RT ) and physical function ( WW ) decreased between 4 years and 10years . Weak urinary stream differed between the RT and WW groups . Fatigue and nocturia were increased in the RT group , and erections decreased in the WW patients over time . No difference in erectile function was seen between the RT and WW groups ( p=0.292 ) . Conclusion . The pattern of urinary and bowel symptoms and sexual function was rather similar , independent of RT or WW . Treatment with RT had minimal influence on HRQoL , in comparison with that of WW , at 10-year follow-up Abstract The psychometric properties of the Italian version of the Hospital Anxiety and Depression Scale  and its utility as a screening instrument for  anxiety and depression  in a non-psychiatric setting were evaluated . The question naire was administered twice to 197 breast cancer patients r and omised in a phase III adjuvant clinical trial : before the start of  chemotherapy  and at the first follow-up visit . The presence of psychiatric disorders was evaluated at the follow-up visit using the Structured Clinical Interview for DSM-III-R in 132 patients . Factor analyses identified two strictly correlated factors . Crohnbach 's alpha for the anxiety and depression scales ranged between 0.80 and 0.85 . At follow-up , 50 patients ( 38 % ) were assigned a current DSM-III-R diagnosis , in most cases adjustment disorders ( 24 % ) or major depressive disorder ( 10 % ) . Receiver operating characteristics ( ROC ) analysis was used to test the discriminant validity for both anxiety and depressive disorders . The comparison of the areas under the curve ( AUC ) between the two scales did not show any difference in identifying either anxiety ( P=0.855 ) or depressive disorders ( P=0.357 ) . The 14-item total scale showed a high internal consistency ( alpha=0.89 and 0.88 ) and a high discriminating power for all the psychiatric disorders ( AUC=0.89 ; 95 % CI=0.83–0.94 ) . The cut-off point that maximised sensitivity ( 84 % ) and specificity ( 79 % ) was 10 . These results suggest that the total score is a valid measure of emotional distress , so that the Italian version of HADS can be used as a screening question naire for psychiatric disorders . The use of the two subscales as a ' case identifier ' or as an outcome measure should be considered with caution Objective To quantify the risk and severity of negative effects of treatment for localised prostate cancer on long term quality of life . Design Population based , prospect i ve cohort study with follow-up over three years . Setting New South Wales , Australia . Participants Men with localised prostate cancer were eligible if aged less than 70 years , diagnosed between October 2000 and October 2002 , and notified to the New South Wales central cancer registry . Controls were r and omly selected from the New South Wales electoral roll and matched to cases by age and postcode . Main outcome measures General health specific and disease specific function up to three years after diagnosis , according to the 12 item short form health survey and the University of California , Los Angeles prostate cancer index . Results 1642 ( 64 % ) cases and 495 ( 63 % ) eligible and contacted controls took part in the study . After adjustment for confounders , all active treatment groups had low odds of having better sexual function than controls , in particular men on and rogen deprivation therapy ( adjusted odds ratio ( OR ) 0.02 , 95 % CI 0.01 to 0.07 ) . Men treated surgically reported the worst urinary function ( adjusted OR 0.17 , 95 % CI 0.13 to 0.22 ) . Bowel function was poorest in cases who had external beam radiotherapy ( adjusted OR 0.44 , 95 % CI 0.30 to 0.64 ) . General physical and mental health scores were similar across treatment groups , but poorest in men 
    Output:
    
Results from two r and omized-controlled-trials ( RCTs ) and one observational study , comparing HRQoL by primary intervention in localized PC survivors suggest that long-term HRQoL does not differ by intervention .
However , observational studies that included a combination of localized and locally advanced stage PC survivors identified HRQoL differences for various scales including physical well-being , social and role function , vitality , and role emotional .
Robust data from two RCTs and one observational study suggest that HRQoL does not seem to differ by intervention .