title: Patient-reported outcomes in randomised controlled trials of colorectal cancer: an analysis determining the availability of robust data to inform clinical decision-making.
abstract: OBJECTIVE
  Randomised controlled trials (RCTs) are the most robust study design measuring outcomes of colorectal cancer (CRC) treatments, but to influence clinical practice trial design and reporting of patient-reported outcomes (PROs) must be of high quality. Objectives of this study were as follows: to examine the quality of PRO reporting in RCTs of CRC treatment; to assess the availability of robust data to inform clinical decision-making; and to investigate whether quality of reporting improved over time.
  
  
  METHODS
  A systematic review from January 2004-February 2012 identified RCTs of CRC treatment describing PROs. Relevant abstracts were screened and manuscripts obtained. Methodological quality was assessed using International Society for Quality of Life Research-patient-reported outcome reporting standards. Changes in reporting quality over time were established by comparison with previous data, and risk of bias was assessed with the Cochrane risk of bias tool.
  
  
  RESULTS
  Sixty-six RCTs were identified, seven studies (10 %) reported survival benefit favouring the experimental treatment, 35 trials (53 %) identified differences in PROs between treatment groups, and the clinical significance of these differences was discussed in 19 studies (29 %). The most commonly reported treatment type was chemotherapy (n = 45; 68 %). Improvements over time in key methodological issues including the documentation of missing data and the discussion of the clinical significance of PROs were found. Thirteen trials (20 %) had high-quality reporting.
  
  
  CONCLUSIONS
  Whilst improvements in PRO quality reporting over time were found, several recent studies still fail to robustly inform clinical practice. Quality of PRO reporting must continue to improve to maximise the clinical impact of PRO findings.
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. jonathan.rees@bristol.ac.uk.|University Hospitals Bristol NHS Foundation Trust, Bristol, UK. jonathan.rees@bristol.ac.uk.
authors.forename: Jonathan R
authors.initials: JR
authors.lastname: Rees
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
authors.forename: Katie
authors.initials: K
authors.lastname: Whale
authors.affiliation: Department of Surgery, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Fish
authors.affiliation: Institute of Applied Health Sciences, University of Aberdeen Medical School, Aberdeen, Scotland, UK.|Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Technology and Science, Trondheim, Norway.
authors.forename: Peter
authors.initials: P
authors.lastname: Fayers
authors.affiliation: Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA) Central Office, Rome, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Cafaro
authors.affiliation: Department of Surgery, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Pusic
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.|University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Jane M
authors.initials: JM
authors.lastname: Blazeby
authors.affiliation: Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA) Central Office, Rome, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
mesh_terms: D000066491:Clinical Decision-Making; D015179:Colorectal Neoplasms / Q000628:therapy*; D006801:Humans; D063868:Patient Outcome Assessment; D011379:Prognosis; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012107:Research Design / Q000592:standards*
keywords: Cancer; Colorectal; Health-related quality of life; Patient-reported outcomes; Randomised; Trails