A core outcome set for localised prostate cancer effectiveness trials.
Author(s)
Type
Journal Article
Abstract
OBJECTIVE: To develop a core outcome set (COS) applicable for effectiveness trials of all interventions for localised prostate cancer. Many treatments exist for localised prostate cancer, although it is unclear which offers the optimal therapeutic ratio; which is confounded by inconsistencies in the selection, definition, measurement and reporting of outcomes in clinical trials. PATIENTS, SUBJECTS AND METHODS: A list of 79 outcomes was derived from a systematic review of published localised prostate cancer effectiveness studies and semi-structured interviews with 15 patients with prostate cancer patients. A two-stage consensus process involving 118 patients and 56 international healthcare professionals (HCPs; cancer specialist nurses, urological surgeons and oncologists) was undertaken, consisting of a three-round Delphi survey followed by a face-to-face consensus panel meeting of 13 HCPs and eight patients. RESULTS: The final COS included 19 outcomes. In all, 12 apply to all interventions: death from prostate cancer, death from any cause, local disease recurrence, distant disease recurrence/metastases, disease progression, need for salvage therapy, overall quality of life, stress urinary incontinence, urinary function, bowel function, faecal incontinence, and sexual function. Seven were intervention-specific: perioperative deaths (surgery), positive surgical margin (surgery), thromboembolic disease (surgery), bothersome or symptomatic urethral or anastomotic stricture (surgery), need for curative treatment (active surveillance), treatment failure (ablative therapy), and side-effects of hormonal therapy (hormone therapy). The UK-centric participants may limit the generalisability to other countries, but trialists should reason why the COS would not be applicable. The default position should not be that a COS developed in one country will automatically not be applicable elsewhere. CONCLUSION: We have established a COS for trials of effectiveness in localised prostate cancer, applicable across all interventions that should be measured in all localised prostate cancer effectiveness trials.
Date Issued
2017-05-03
Date Acceptance
2017-03-27
Citation
BJU International, 2017, 120 (5B), pp.E64-E79
ISSN
1464-4096
Publisher
Wiley
Start Page
E64
End Page
E79
Journal / Book Title
BJU International
Volume
120
Issue
5B
Copyright Statement
This is the peer reviewed version of the following article: MacLennan, S., Williamson, P. R., Bekema, H., Campbell, M., Ramsay, C., N'Dow, J., MacLennan, S., Vale, L., Dahm, P., Mottet, N., Lam, T. and the COMPACTERS Study Group (2017), A core outcome set for localised prostate cancer effectiveness trials. BJU Int, which has been published in final form at https://dx.doi.org/10.1111/bju.13854. This article may be used for non-commercial purposes in accordance With Wiley Terms and Conditions for self-archiving.
Subjects
Delphi survey
clinical trials
consensus group meeting
consensus process
core outcome set
localised prostate cancer
Publication Status
Published