title: A core outcome set for localised prostate cancer effectiveness trials: protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey.
abstract: BACKGROUND
  Prostate cancer is a growing health problem worldwide. The management of localised prostate cancer is controversial. It is unclear which of several surgical, radiotherapeutic, ablative, and surveillance treatments is the most effective. All have cost, process and recovery, and morbidity implications which add to treatment decision-making complexity for patients and healthcare professionals. Evidence from randomised controlled trials (RCTs) is not optimal because of uncertainty as to what constitutes important outcomes. Another issue hampering evidence synthesis is heterogeneity of outcome definition, measurement, and reporting. This project aims to determine which outcomes are the most important to patients and healthcare professionals, and use these findings to recommend a standardised core outcome set for comparative effectiveness trials of treatments for localised prostate cancer, to optimise decision-making.
  
  
  METHODS
  The range of potentially important outcomes and measures will be identified through systematic reviews of the literature and semi-structured interviews with patients. A consultation exercise involving representatives from two key stakeholder groups (patients and healthcare professionals) will ratify the list of outcomes to be entered into a three round Delphi study. The Delphi process will refine and prioritise the list of identified outcomes. A methodological substudy (nested RCT design) will also be undertaken. Participants will be randomised after round one of the Delphi study to one of three feedback groups, based on different feedback strategies, in order to explore the potential impact of feedback strategies on participant responses. This may assist the design of a future core outcome set and Delphi studies. Following the Delphi study, a final consensus meeting attended by representatives from both stakeholder groups will determine the final recommended core outcome set.
  
  
  CONCLUSIONS
  This study will inform clinical practice and future trials of interventions of localised prostate cancer by standardising a core outcome set which should be considered in comparative effectiveness studies for localised prostate cancer.
authors.affiliation: Academic Urology Unit, University of Aberdeen, Cornhill Road, Aberdeen, UK, AB25 2ZD. steven.maclennan@abdn.ac.uk.
authors.forename: Steven
authors.initials: S
authors.lastname: MacLennan
authors.affiliation: Department of Critical Care, University of Groningen, University Medical Center Groningen, Hanzleplein, Groningen, The Netherlands, 9700 RB. hjbekema@gmail.com.
authors.forename: Hendrika J
authors.initials: HJ
authors.lastname: Bekema
authors.affiliation: Department of Biostatistics, University of Liverpool, Crown Street, Liverpool, UK, L69 3BX. P.R.Williamson@liverpool.ac.uk.
authors.forename: Paula R
authors.initials: PR
authors.lastname: Williamson
authors.affiliation: Health Services Research Unit, University of Aberdeen, Cornhill Road, Aberdeen, UK, AB25 2ZD. m.k.campbell@abdn.ac.uk.
authors.forename: Marion K
authors.initials: MK
authors.lastname: Campbell
authors.affiliation: Academic Urology Unit, University of Aberdeen, Cornhill Road, Aberdeen, UK, AB25 2ZD. fiona.stewart@abdn.ac.uk.
authors.forename: Fiona
authors.initials: F
authors.lastname: Stewart
authors.affiliation: Academic Urology Unit, University of Aberdeen, Cornhill Road, Aberdeen, UK, AB25 2ZD. s.maclennan@abdn.ac.uk.
authors.forename: Sara J
authors.initials: SJ
authors.lastname: MacLennan
authors.affiliation: Academic Urology Unit, University of Aberdeen, Cornhill Road, Aberdeen, UK, AB25 2ZD. j.ndow@abdn.ac.uk.|Department of Urology, Aberdeen Royal Infirmary, Foresterhill Road, Aberdeen, UK, AB25 2ZD. j.ndow@abdn.ac.uk.
authors.forename: James M O
authors.initials: JM
authors.lastname: N'Dow
authors.affiliation: Academic Urology Unit, University of Aberdeen, Cornhill Road, Aberdeen, UK, AB25 2ZD. thomasbllam@abdn.ac.uk.|Department of Urology, Aberdeen Royal Infirmary, Foresterhill Road, Aberdeen, UK, AB25 2ZD. thomasbllam@abdn.ac.uk.
authors.forename: Thomas B L
authors.initials: TB
authors.lastname: Lam
mesh_terms: D002985:Clinical Protocols; D003697:Delphi Technique; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D011471:Prostatic Neoplasms / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D000078202:Systematic Reviews as Topic