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  • Core outcome research measures in anal cancer (CORMAC): protocol for systematic review, qualitative interviews and Delphi survey to develop a core outcome set in anal cancer

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Oncology
Protocol
Core outcome research measures in anal cancer (CORMAC): protocol for systematic review, qualitative interviews and Delphi survey to develop a core outcome set in anal cancer
  1. Rebecca Fish1,2,
  2. Caroline Sanders3,
  3. Paula R Williamson4,5,
  4. Andrew G Renehan1,2
  1. 1 Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
  2. 2 Colorectal and Peritoneal Oncology Centre, Christie NHS Foundation Trust, Manchester, UK
  3. 3 Centre for Primary Care, University of Manchester, Manchester, UK
  4. 4 Department of Biostatistics, University of Liverpool, Liverpool, UK
  5. 5 Medical Research Council North West Hub for Trials Methodology Research, Liverpool, UK
  1. Correspondence to Dr Rebecca Fish; rebecca.fish-2{at}manchester.ac.uk

Abstract

Introduction The incidence of anal squamous cell carcinoma (ASCC) has increased threefold in the last 30 years. Initial treatment is chemoradiotherapy, associated with short-term and long-term side effects. Future therapy innovations aim to reduce morbidity in treatment of early tumours while maintaining treatment efficacy, and to escalate treatment intensity in locally advanced tumours with acceptable quality of life (QoL). However, all phase III randomised controlled trials to-date have utilised different primary outcomes, which hinders evidence synthesis and presents challenges to the selection of optimal outcomes in future trials. No trial comprehensively assessed long-term side effects and QoL, suggesting outcomes reflecting issues important to patients are under-represented. This project aims to determine the priority outcomes for all stakeholders and reach agreement on a standardised core set of outcomes to be measured and reported on in all future ASCC trials.

Methods and analysis A systematic review will identify all outcomes reported in trials and observational studies of chemoradiotherapy as primary treatment for ASCC. Outcomes of importance to patients will be identified through patient interviews. The long list of outcomes generated from the systematic review and interviews will be used to create a two-round Delphi process, including key stakeholders (patients and healthcare professionals). The results of the Delphi will be discussed at a face-to-face consensus meeting. Discussion will focus on outcomes that did not achieve consensus through the Delphi process and conclude with anonymous voting to ratify the final core outcome set (COS).

Ethics and dissemination The final COS will feed directly into the PersonaLising Anal cancer radioTherapy dOse (PLATO) national anal cancer trials and the Association of coloproctologists of Great Britain and Ireland (ACPGBI) supported national anal cancer database. Utilisation of the COS will increase the relevance of research output to all stakeholders and increase the capacity for data synthesis between trials. This study has ethical approval and is registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative.

Trial registration number PROSPERO registration ID: CRD42016036540

  • core outcome set
  • anal cancer
  • patient reported outcomes
  • delphi
  • radiotherapy

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2017-018726

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    Footnotes

    • Twitter @cormacstudy @beccajfish

    • Contributors AGR and PW conceived of the project and are the joint principal investigators for the study. RF is the clinical research fellow for the project, is responsible for management of the project and wrote the protocol and manuscript. AGR, PW and CS provide supervision and have had input to all aspects of the project and have commented on drafts of the manuscript. All authors have read and approved the manuscript.

    • Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1013-32064).

    • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

    • Competing interests None declared.

    • Ethics approval Greater Manchester East REC 15/NW/0971 and Newcastle and North Tyneside REC 16/NE/0392.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.