Protocol for the development of a core outcome set and reporting guidelines for locoregional treatment in neoadjuvant systemic breast cancer treatment trials: The PRECEDENT Project

Shelley Potter, Kerry N L Avery, Rosina Ahmed, Jana De Boniface, Sanjoy Chatterjee, David Dodwell, Peter Dubsky, Hiroji Iwata, Michael Y Jiang, Han-Byoel Lee, Mairead MacKenzie, Fiorita Poulakaki, Andrea Richardson, Karla Sepulveda, Andrew Spillane, Alastair Thompson, Gustavo Werutsky, Jean Wright, Nicholas Zendkowski, Katherine CowanStuart McIntosh*

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

Abstract

Introduction

Neoadjuvant systemic anticancer therapy (neoSACT) is increasingly used in the treatment of early breast cancer. Response to therapy is prognostic and allows locoregional and adjuvant systemic treatments to be tailored to minimise morbidity and optimise oncological outcomes and quality of life. Accurate information about locoregional treatments following neoSACT is vital to allow translation of downstaging benefits into practice and facilitate meaningful interpretation of oncological outcomes, particularly locoregional recurrence. Reporting of locoregional treatments in neoSACT studies, however, is currently poor. Development of a core outcome set (COS) and reporting guidelines is one strategy by which this may be improved.

Methods and analysis

A COS for reporting of locoregional treatment (surgery and radiotherapy) in neoSACT trials will be developed in accordance with COMET (Core Outcome Measures in Effectiveness Trials) and COS-STAD (Core Outcome Set- Standards for Development) guidelines. Reporting guidance will be developed concurrently.

The project will have three phases:
1. Generation of a long list of relevant outcome domains and reporting items from a systematic review of published neoSACT studies and interviews with key stakeholders. Identified items and domains will be categorised and formatted into Delphi consensus questionnaire items.
2. At least two rounds of an international online Delphi survey in which at least 250 key stakeholders (surgeons/oncologists/radiologists/pathologists/trialists/methodologists) will score the importance of reporting each outcome.
3. A consensus meeting with key stakeholders to discuss and agree the final COS and reporting guidance.

Ethics and dissemination

Ethical approval for the consensus process will be obtained from the Queen’s University Belfast Faculty Ethics committee. The COS/reporting guidelines will be presented at international meetings and published in peer-reviewed journals. Dissemination materials will be produced in collaboration with our steering group and patient advocates so the results can be shared widely.

Registration: The study has been prospectively registered on the COMET website (https://www.comet-initiative.org/Studies/Details/2854).
Original languageEnglish
JournalBMJ Open
Publication statusAccepted/In press - 3 Apr 2024

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