A core outcome set for localised prostate cancer effectiveness trials

Steven MacLennan, Paula R. Williamson, Hendrika J Bekema, Marion Campbell, Craig Ramsay, James N'Dow, Sara MacLennan, Luke Vale, Thomas Lam, COMPACTERS study group

Research output: Contribution to journalArticle

15 Citations (Scopus)
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Abstract

Objective: To develop a core outcome set (COS) applicable for effectiveness trials of all interventions for localised prostate cancer.

Background: Many treatments exist for localised prostate cancer, although it is unclear which offers the optimal therapeutic ratio. This is confounded by inconsistencies in the selection, definition, measurement and reporting of outcomes in clinical trials.

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 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 8 patients.

Results: The final COS included 19 outcomes. Twelve 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, 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 which should be measured in all localised prostate cancer effectiveness trials.

This article is protected by copyright. All rights reserved.
Original languageEnglish
Pages (from-to)E64-79
Number of pages16
JournalBJU International
Volume120
Issue number5B
Early online date3 May 2017
DOIs
Publication statusPublished - Nov 2017

Fingerprint

Prostatic Neoplasms
Consensus
Therapeutics
Delivery of Health Care
Recurrence
Salvage Therapy
Fecal Incontinence
Stress Urinary Incontinence
Treatment Failure
Psychological Stress
Disease Progression
Cause of Death
Pathologic Constriction
Quality of Life
Clinical Trials
Hormones
Interviews
Neoplasm Metastasis
Neoplasms

Keywords

  • core outcome set
  • localised prostate cancer
  • clinical trials
  • consensus process
  • Delphi survey
  • consensus group meeting

ASJC Scopus subject areas

  • Medicine(all)

Cite this

A core outcome set for localised prostate cancer effectiveness trials. / MacLennan, Steven; Williamson, Paula R.; Bekema, Hendrika J; Campbell, Marion; Ramsay, Craig; N'Dow, James; MacLennan, Sara; Vale, Luke; Lam, Thomas; COMPACTERS study group.

In: BJU International, Vol. 120, No. 5B, 11.2017, p. E64-79.

Research output: Contribution to journalArticle

MacLennan, Steven ; Williamson, Paula R. ; Bekema, Hendrika J ; Campbell, Marion ; Ramsay, Craig ; N'Dow, James ; MacLennan, Sara ; Vale, Luke ; Lam, Thomas ; COMPACTERS study group. / A core outcome set for localised prostate cancer effectiveness trials. In: BJU International. 2017 ; Vol. 120, No. 5B. pp. E64-79.
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abstract = "Objective: To develop a core outcome set (COS) applicable for effectiveness trials of all interventions for localised prostate cancer.Background: Many treatments exist for localised prostate cancer, although it is unclear which offers the optimal therapeutic ratio. This is confounded by inconsistencies in the selection, definition, measurement and reporting of outcomes in clinical trials.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 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 8 patients.Results: The final COS included 19 outcomes. Twelve 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, 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 which should be measured in all localised prostate cancer effectiveness trials.This article is protected by copyright. All rights reserved.",
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author = "Steven MacLennan and Williamson, {Paula R.} and Bekema, {Hendrika J} and Marion Campbell and Craig Ramsay and James N'Dow and Sara MacLennan and Luke Vale and Thomas Lam and {COMPACTERS study group}",
note = "Acknowledgements The authors wish to thank the following: Heather Bagley and Linda Pennet for their advice and assistance regarding patient and public involvement in research; Janice Forsyth and Sarah Murdoch for their assistance with logistics before and during the consensus meeting; Melanie Harper-Jones and Duncan Appelbe for their support in designing and managing the online Delphi survey and data; Vikki Entwistle for her advice during the protocol development stage; and Jane Blazeby and Liz Gargon for providing advice on Delphi survey and consensus meeting methods. Finally, we would like to thank all patients and HCPs who took part in the interview study and Delphi survey. Funded by Cancer Research Aberdeen and North East Scotland (CRANES) Sonacare Inc Sophiris Biocorp Inc Trod Medical Takeda pharmaceutical / Millenium Astellas Pierre Fabre Sanofi Pasteur",
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AU - MacLennan, Steven

AU - Williamson, Paula R.

AU - Bekema, Hendrika J

AU - Campbell, Marion

AU - Ramsay, Craig

AU - N'Dow, James

AU - MacLennan, Sara

AU - Vale, Luke

AU - Lam, Thomas

AU - COMPACTERS study group

N1 - Acknowledgements The authors wish to thank the following: Heather Bagley and Linda Pennet for their advice and assistance regarding patient and public involvement in research; Janice Forsyth and Sarah Murdoch for their assistance with logistics before and during the consensus meeting; Melanie Harper-Jones and Duncan Appelbe for their support in designing and managing the online Delphi survey and data; Vikki Entwistle for her advice during the protocol development stage; and Jane Blazeby and Liz Gargon for providing advice on Delphi survey and consensus meeting methods. Finally, we would like to thank all patients and HCPs who took part in the interview study and Delphi survey. Funded by Cancer Research Aberdeen and North East Scotland (CRANES) Sonacare Inc Sophiris Biocorp Inc Trod Medical Takeda pharmaceutical / Millenium Astellas Pierre Fabre Sanofi Pasteur

PY - 2017/11

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N2 - Objective: To develop a core outcome set (COS) applicable for effectiveness trials of all interventions for localised prostate cancer.Background: Many treatments exist for localised prostate cancer, although it is unclear which offers the optimal therapeutic ratio. This is confounded by inconsistencies in the selection, definition, measurement and reporting of outcomes in clinical trials.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 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 8 patients.Results: The final COS included 19 outcomes. Twelve 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, 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 which should be measured in all localised prostate cancer effectiveness trials.This article is protected by copyright. All rights reserved.

AB - Objective: To develop a core outcome set (COS) applicable for effectiveness trials of all interventions for localised prostate cancer.Background: Many treatments exist for localised prostate cancer, although it is unclear which offers the optimal therapeutic ratio. This is confounded by inconsistencies in the selection, definition, measurement and reporting of outcomes in clinical trials.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 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 8 patients.Results: The final COS included 19 outcomes. Twelve 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, 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 which should be measured in all localised prostate cancer effectiveness trials.This article is protected by copyright. All rights reserved.

KW - core outcome set

KW - localised prostate cancer

KW - clinical trials

KW - consensus process

KW - Delphi survey

KW - consensus group meeting

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M3 - Article

C2 - 28346770

VL - 120

SP - E64-79

JO - BJU International

JF - BJU International

SN - 1464-4096

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