title: Trial outcomes and information for clinical decision-making: a comparative study of opinions of health professionals.
abstract: Trials are robust sources of data for clinical practice; however, trial outcomes may not reflect what is important to communicate for decision-making. The study compared clinicians' views of outcomes to include in a core outcome set for colorectal cancer (CRC) surgery, with what clinicians considered important information for clinical practice (core information).
  
  
  
  Potential outcome/information domains were identified through systematic literature reviews, reviews of hospital information leaflets and interviews with patients. These were organized into six categories and used to design a questionnaire survey that asked surgeons and nurses from a sample of CRC centers to rate the importance of each domain as an outcome or as information on a nine-point Likert scale. Respondents were re-surveyed (round 2) following group feedback (Delphi methods). Comparisons were made by calculating the difference in mean scores between the outcomes and information domains, and paired t tests were used to explore the difference between mean scores of the six outcome/information categories.
  
  
  
  Data sources identified 1216 outcome/information items for CRC surgery that informed a 94-item questionnaire. First-round questionnaires were returned from 63/81 (78 %) of centers. Clinicians rated 76/94 (84 %) domains of higher importance to measure in trials than information to communicate to patients in round 1. This was reduced to 24/47 (51 %) in round 2. The greatest difference was evident in domains regarding survival, which was rated much more highly as a trial outcome than an important piece of information for decision-making (difference in mean 2.3, 95 % CI 1.9 to 2.8, p <0.0001). Specific complications and quality-of-life domains were rated similarly (difference in mean 0.18, 95 % CI -0.1 to 0.4, p = 0.2 and difference in mean 0.2, 95 % CI -0.1 to 0.5, p = 0.2, respectively).
  
  
  
  Whilst clinicians want to measure key outcomes in trials, they rate these as less important to communicate in decision-making with patients. This discrepancy needs to be explored and addressed to maximize the impact of trials on clinical practice.
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. angus.mcnair@bristol.ac.uk.|Severn School of Surgery, Bristol, UK. angus.mcnair@bristol.ac.uk.
authors.forename: Angus G K
authors.initials: AG
authors.lastname: McNair
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: Sara T
authors.initials: ST
authors.lastname: Brookes
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.|Division of Surgery Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Robert N
authors.initials: RN
authors.lastname: Whistance
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.|Division of Surgery Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Rachael O
authors.initials: RO
authors.lastname: Forsythe
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: Rhiannon
authors.initials: R
authors.lastname: Macefield
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: Jonathan
authors.initials: J
authors.lastname: Rees
authors.affiliation: Colorectal Cancer Patient Representative, North Bristol NHS Trust, Bristol, UK.
authors.forename: James
authors.initials: J
authors.lastname: Jones
authors.affiliation: Colorectal Cancer Patient Representative, North Bristol NHS Trust, Bristol, UK.
authors.forename: George
authors.initials: G
authors.lastname: Smith
authors.affiliation: Department of General Surgery, North Bristol NHS Trust, Bristol, UK.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Pullyblank
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: Kerry N L
authors.initials: KN
authors.lastname: Avery
authors.affiliation: Colorectal Surgery Unit, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Thomas
authors.affiliation: Colorectal Surgery Unit, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Sylvester
authors.affiliation: Colorectal Consumer Liaison Group, National Cancer Research Institute, London, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Russell
authors.affiliation: Colorectal Consumer Liaison Group, National Cancer Research Institute, London, UK.
authors.forename: Alfred
authors.initials: A
authors.lastname: Oliver
authors.affiliation: Academic Department of Surgery, University of Birmingham, Birmingham, UK.
authors.forename: Dion
authors.initials: D
authors.lastname: Morton
authors.affiliation: Department of Surgery, St Mark's Hospital and Academic Institute, Harrow, UK.
authors.forename: Robin
authors.initials: R
authors.lastname: Kennedy
authors.affiliation: Academic Surgical Unit, St James' University Hospital NHS Trust, Leeds, UK.
authors.forename: David G
authors.initials: DG
authors.lastname: Jayne
authors.affiliation: Centre for Ethics in Medicine, University of Bristol, Bristol, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Huxtable
authors.affiliation: Colorectal Site Specific Group, Somerset, Wiltshire, Avon and Gloucestershire, South West Cancer Network, Taunton, UK.
authors.forename: Rowland
authors.initials: R
authors.lastname: Hackett
authors.affiliation: Centre for Statistics in Medicine and Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Dutton
authors.affiliation: Department of Colorectal Surgery, Plymouth Hospitals NHS Trust, Plymouth, UK.
authors.forename: Mark G
authors.initials: MG
authors.lastname: Coleman
authors.affiliation: Colorectal Surgery Unit, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Mia
authors.initials: M
authors.lastname: Card
authors.affiliation: Clinical Trials Research Unit, University of Leeds, Leeds, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Brown
authors.affiliation: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.|Division of Surgery Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Jane M
authors.initials: JM
authors.lastname: Blazeby
mesh_terms: D000328:Adult; D001291:Attitude of Health Personnel; D000066491:Clinical Decision-Making; D003082:Colectomy / Q000009:adverse effects; D015179:Colorectal Neoplasms / Q000473:pathology / Q000601:surgery*; D003697:Delphi Technique; D019317:Evidence-Based Medicine; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D009726:Nurses / Q000523:psychology*; D018579:Patient Selection; D011183:Postoperative Complications / Q000209:etiology; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D066231:Surgeons / Q000523:psychology*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome