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.
View the protocol at: http://www.trialsjournal.com/content/16/1/76
To develop a core outcome set (COS) applicable for effectiveness trials of all interventions for localised prostate cancer.
ContributorsSteven MacLennan* , Paula R. Williamson†, Hanneke Bekema‡, Marion Campbell§, Craig Ramsay§, James N’Dow*¶, Sara MacLennan*, Luke Vale**, Philipp Dahm††,‡‡, Nicolas Mottet§§, Thomas Lam*¶ and on behalf of the COMPACTERS Study Group1: Paul Abel, Hashim U. Ahmed, Gary Akehurst, Robert Almquist, Karl Beck, David Budd, Steven Canfield, James Catto, Philip Cornford, William Cross, Alexander Ewen, Judith Grant, Rakesh Heer, David Hurst, Rob Jones, Roger Kockelbergh, Andrew Mackie, Graham MacDonald, Alan McNeill, Malcolm Mason, Sam McClinton, Duncan McLaren, Hugh Mostafid, Ian Pearce, Linda Pennet, Justine Royle, Hans Schreuder, Grant D. Stewart, Henk van der Poel, Kevin Wardlaw, Thomas Wiegel
Disease Category: Cancer, Urology
Disease Name: Prostate cancer
Age Range: 45 - 75
Sex: Male
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Service providers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review
- Interview
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 was undertaken, consisting of a three-round Delphi survey followed by a face-to-face consensus panel meeting of 13 HCPs and eight patients.