***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: 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 Background R and omized controlled trials ( RCTs ) have reported improved or unchanged three-year survival following  laparoscopic colon resection ( LCR ) for colon cancer compared with that following open resection ( OCR ) . The aim of this study was to determine health-related quality of life ( HRQL ) in patients r and omized to laparoscopic or open resection for colon cancer . Methods In total , 285 patients ( 130 LCR , 155 OCR ) from seven Swedish centers were included .  HRQL was assessed preoperatively and at 2 , 4 , and 12 weeks postoperatively with the EQ-5D and EORTC QLQ-C30 instruments . Results The LCR patients did significantly better on the social function component of the EORTC QLQ-C30 at two and four weeks and on the role function component at two weeks . Conclusion Laparoscopic resection for colon cancer improved quality of life during the first postoperative month UNLABELLED The st and ard of reporting of r and omized controlled trials ( RCTs ) is important to the interpretation of outcomes such as health-related quality of life ( HRQL ) . HRQL is used increasingly as an outcome in clinical cancer trials . DESIGN All 1997 issues of 36 selected journals were h and search ed to identify original articles that included the term " quality of life " in the title , abstract , keywords or methods . Studies were included if they were RCTs and addressed cancer-related topics . A checklist to assess the adequacy of reporting of HRQL was developed based on a guideline previously published by an expert panel . Two unblinded review ers applied the  quality of life reporting ( QLR ) and CONSORT checklists  , along with an instrument to assess the likelihood of bias to each selected RCT . RESULTS 72 articles were identified of which 20 were RCTs and cancer-related . For these 20 reports the median number of items in the QLR checklist that were adequately reported is 42 % ( range 15 % to 85 % ) . The median number of items in the CONSORT checklist that were adequately reported is 70 % ( range 47 % to 95 % ) . The mean score for the instrument to assess the likelihood for bias is 2.6 ( 95 % CI 2 . 08 - 3.12 ) . CONCLUSIONS The current st and ard of reporting of HRQL needs to be improved . Major deficiencies that should be addressed are failure to provide a rationale for HRQL assessment and inadequate description of methodology . Development and application of structured formats for presentation of HRQL may help to improve the st and ard of reporting of HRQL in the literature BACKGROUND Colonic stenting as a bridge to elective surgery is an alternative for emergency surgery in patients with acute malignant colonic obstruction , but its benefits are uncertain . We aim ed to establish whether colonic stenting has better health outcomes than does emergency surgery . METHODS Patients with acute obstructive left-sided colorectal cancer were enrolled from 25 hospitals in the Netherl and s and r and omly assigned ( 1:1 ratio ) to receive colonic stenting as a bridge to elective surgery or emergency surgery . The r and omisation sequence was computer generated with permuted blocks and was stratified by centre ; treatment allocation was concealed by use of a web-based application . Investigators and patients were unmasked to treatment assignment . The primary outcome was mean global health status during a 6-month follow-up , which was assessed with the QL2 subscale of the European Organisation for Research and Treatment of Cancer quality -of-life question naire ( EORTC QLQ-C30 ) . Analysis was by intention to treat . This study is registered , number IS RCT N46462267 . FINDINGS Between March 9 , 2007 , and Aug 27 , 2009 , 98 patients were assigned to receive colonic stenting ( n=47 patients ) or emergency surgery ( n=51 ) . Two successive interim analyses showed increased 30-day morbidity in the colonic stenting group , with an absolute risk increase of 0.19 ( 95 % CI -0.06 to 0.41 ) in analysis of the first 60 patients ( 14 of 28 patients receiving colonic stenting vs 10 of 32 receiving emergency surgery ) , and an absolute risk increase of 0.19 ( -0.01 to 0.37 ) in analysis of the first 90 patients ( 23 of 47 patients vs 13 of 43 ) . In accordance with the advice of the data safety monitoring committee , the study was suspended on Sept 18 , 2009 , and ended on March 12 , 2010 . At the final analysis of 98 patients , mean global health status during follow-up was 63.0 ( SD 23.8 ) in the colonic stenting group and 61.4 ( SD 21.9 ) in the emergency surgery group ; after adjustment for baseline values , mean global health status did not differ between treatment groups ( -4.7 , 95 % CI -14.8 to 5.5 , p=0.36 ) . No difference was recorded between treatment groups in 30-day mortality ( absolute risk difference -0.01 , 95 % CI -0.14 to 0.12 , p=0.89 ) , overall mortality ( -0.02 , -0.17 to 0.14 , p=0.84 ) , morbidity ( -0.08 , -0.27 to 0.11 , p=0.43 ) , and stoma rates at latest follow-up ( 0.09 , -0.10 to 0.27 , p=0.35 ) . However , the emergency surgery group had an increased stoma rate directly after initial intervention ( 0.23 , 0.04 to 0.40 , p=0.016 ) and a reduced frequency of stoma-related problems ( between-group difference -12.0 , -23.7 to -0.2 , p=0.046 ) . The most common serious adverse events were abscess ( three in the colonic stenting group vs four in the emergency surgery group ) , perforations ( six vs none ) , and anastomotic leakage ( five vs one ) , and the most common adverse events were pneumonia ( three vs one ) and wound infection ( one vs three ) . INTERPRETATION Colonic stenting has no decisive clinical advantages to emergency surgery . It could be used as an alternative treatment in as yet undefined subsets of patients , although with caution because of concerns about tumour spread caused by perforations . FUNDING None Background Postoperative outcomes of patients undergoing laparoscopic-assisted colectomy ( LAC )  have shown modest improvements in recovery but only minimal differences in quality of life ( QOL ) compared with open colectomy . We therefore sought to assess the effect of LAC on QOL in the short and long term , using individual item analysis of multi-item QOL assessment s. Methods QOL variables were analyzed in 449 r and omized patients from the COST trial 93 - 46 - 53 ( INT 0146 ) . Both cross-sectional single-time and change from baseline assessment s were run at day 2 , week 2 , month 2 , and month 18 postoperatively in an intention-to-treat analysis using Wilcoxon rank-sum tests . Stepwise regression models were used to determine predictors of QOL . Results Of 449 colon cancer patients , 230 underwent LAC and 219 underwent open colectomy .  Subdomain analysis revealed a clinical ly moderate improvement from baseline  for LAC in total QOL index at 18 months ( P = 0.02 ) as well as other small symptomatic improvements . Poor preoperative QOL as indicated by a rating scale of ≤ 50 was an independent predictor of poor QOL at 2 months postoperatively . QOL variables related to survival were baseline support ( P = 0.001 ) and baseline outlook ( P = 0.01 ) . Conclusions Eighteen months after surgery , any differences in quality of life between patients r and omized to LAC or open colectomy favored LAC . However , the magnitude of the benefits was small . Patients with poor preoperative QOL appear to be at higher risk for difficult postoperative courses , and may be c and i date s for enhanced ancillary services to address their particular needs BACKGROUND Cetuximab , an IgG1 chimeric monoclonal antibody against epidermal growth factor receptor ( EGFR ) , has activity against colorectal cancers that express EGFR . METHODS From December 2003 to August 2005 , 572 patients who had colorectal cancer expressing immunohistochemically detectable EGFR and who had been previously treated with a fluoropyrimidine , irinotecan , and oxaliplatin or had contraindications to treatment with these drugs underwent r and omization to an initial dose of 400 mg of cetuximab per square meter of body-surface area followed by a weekly infusion of 250 mg per square meter plus best supportive care  ( 287 patients ) or best supportive care alone  ( 285 patients ) . The primary end point was overall survival . RESULTS In comparison with best supportive care alone , cetuximab treatment was associated with a significant improvement in overall survival ( hazard ratio for death , 0.77 ; 95 % confidence interval [ CI ] , 0.64 to 0.92 ; P=0.005 ) and in progression-free survival ( hazard ratio for disease progression or death , 0.68 ; 95 % CI , 0.57 to 0.80 ; P<0.001 ) . These benefits were robust after adjustment in a multivariable Cox proportional-hazards model . The median overall survival was 6.1 months in the cetuximab group and 4.6 months in the group assigned to supportive care alone . Partial responses occurred in 23 patients ( 8.0 % ) in the cetuximab group but in none in the group assigned to supportive care alone ( P<0.001 ) ; the disease was stable in an additional 31.4 % of patients assigned to cetuximab and in 10.9 % of patients assigned to supportive care alone ( P<0.001 ) . Quality of life was better preserved in the cetuximab group , with less deterioration in physical function and global health status scores ( both P<0.05 ) . Cetuximab treatment was associated with a characteristic rash ; a rash of grade 2 or higher was strongly associated with improved survival ( hazard ratio for death , 0.33 ; 95 % CI , 0.22 to 0.50 ; P<0.001 ) . The incidence of any adverse event of grade 3 or higher was 78.5 % in the cetuximab group and 59.1 % in the group assigned to supportive care alone ( P<0.001 ) . CONCLUSIONS Cetuximab improves overall survival and progression-free survival and preserves quality -of-life measures in patients with colorectal cancer in whom other treatments have failed . ( Clinical Trials.gov number , NCT00079066 [ Clinical Trials.gov ] . ) PURPOSE Preoperative short-term radiotherapy improves local control in patients treated with total mesorectal excision ( TME ) . This study was performed to assess the presence and magnitude of long-term side effects of preoperative 5 x 5 Gy radiotherapy and TME . Also , hospital treatment was recorded for diseases possibly related to late side effects of rectal cancer treatment . PATIENTS AND METHODS Long-term morbidity was assessed in patients from the prospect i ve r and omized TME trial , which investigated the efficacy of 5 x 5 Gy before TME surgery 
    Output:
    
Conclusions Whilst improvements in PRO quality reporting over time were found , several recent studies still fail to robustly inform clinical practice .