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

Steven MacLennan, Hendrika J. Bekema, Paula R. Williamson, Marion K. Campbell, Fiona Stewart, Sara J. MacLennan, James M. O. N'Dow, Thomas B. L. Lam*

*Corresponding author for this work

Research output: Contribution to journalLiterature review

29 Citations (Scopus)
5 Downloads (Pure)

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/Design: 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.

Discussion: 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.

Original languageEnglish
Article number76
Number of pages10
JournalTrials
Volume16
DOIs
Publication statusPublished - 4 Mar 2015

Keywords

  • core outcome set
  • systematic review
  • semi-structured interviews
  • Delphi
  • consensus methods
  • treatment for localised prostate cancer
  • radical prostatectomy
  • clinical-trials
  • United-Kingdom
  • management
  • cohort
  • rates
  • risk
  • men

Cite this

@article{b047a53021eb44ce8926ad9b7436dbf5,
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/Design: 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.Discussion: 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.",
keywords = "core outcome set, systematic review, semi-structured interviews, Delphi, consensus methods, treatment for localised prostate cancer, radical prostatectomy, clinical-trials, United-Kingdom, management, cohort, rates, risk, men",
author = "Steven MacLennan and Bekema, {Hendrika J.} and Williamson, {Paula R.} and Campbell, {Marion K.} and Fiona Stewart and MacLennan, {Sara J.} and N'Dow, {James M. O.} and Lam, {Thomas B. L.}",
note = "Acknowledgements We would like to thank Professor Craig Ramsay, Professor Luke Vale, and Professor Vikki Entwistle for their comments on earlier drafts of the protocol. This study is funded by the Cancer Research Aberdeen and North East Scotland (CRANES) charity. Paula Williamson would like to acknowledge funding from the European Union Seventh Framework Programme (FP7/2007-2013, FP7/2007-2011) under grant agreement number 305081 for the COMET initiative, which provided support for this work.",
year = "2015",
month = "3",
day = "4",
doi = "10.1186/s13063-015-0598-0",
language = "English",
volume = "16",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",

}

TY - JOUR

T1 - A core outcome set for localised prostate cancer effectiveness trials

T2 - protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey

AU - MacLennan, Steven

AU - Bekema, Hendrika J.

AU - Williamson, Paula R.

AU - Campbell, Marion K.

AU - Stewart, Fiona

AU - MacLennan, Sara J.

AU - N'Dow, James M. O.

AU - Lam, Thomas B. L.

N1 - Acknowledgements We would like to thank Professor Craig Ramsay, Professor Luke Vale, and Professor Vikki Entwistle for their comments on earlier drafts of the protocol. This study is funded by the Cancer Research Aberdeen and North East Scotland (CRANES) charity. Paula Williamson would like to acknowledge funding from the European Union Seventh Framework Programme (FP7/2007-2013, FP7/2007-2011) under grant agreement number 305081 for the COMET initiative, which provided support for this work.

PY - 2015/3/4

Y1 - 2015/3/4

N2 - 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/Design: 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.Discussion: 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.

AB - 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/Design: 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.Discussion: 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.

KW - core outcome set

KW - systematic review

KW - semi-structured interviews

KW - Delphi

KW - consensus methods

KW - treatment for localised prostate cancer

KW - radical prostatectomy

KW - clinical-trials

KW - United-Kingdom

KW - management

KW - cohort

KW - rates

KW - risk

KW - men

U2 - 10.1186/s13063-015-0598-0

DO - 10.1186/s13063-015-0598-0

M3 - Literature review

VL - 16

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 76

ER -