Evidence map›Paper›PMID 41974548›Full record

ArticleBMJ open2026

Development of a CORe outcome set for clinical trials of RECTal cancer treatment: protocol for the CORRECT initiative.

Richard Garfinkle, Manju George, Krishan Jethwa, Peter Johansen, Mary Lakaszawski, Arun Nagarajan, Neil Smart, Patricia Sylla, Te Vuong, Marylise Boutros and 1 more

Abstract read
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Richard GarfinkleDivision of Colon and Rectal Surgery, Jewish General Hospital, Montreal, Québec, Canada richard.garfinkle@mail.mcgill.ca.ORCID http://orcid.org/0000-0002-8052-778X
Manju GeorgePaltown Development Foundation/COLONTOWN, Crownsville, Maryland, USA.
Krishan JethwaDepartment of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Peter JohansenDepartment of Anthropology, McGill University, Montreal, Québec, Canada.
Mary LakaszawskiDepartment of Surgery, Mount Sinai Hospital, New York City, New York, USA.
Arun NagarajanDepartment of Haematology-Oncology, Cleveland Clinic Florida, Weston, Florida, USA.
Neil SmartDepartment of Colorectal Surgery, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
Patricia SyllaDivision of Colon and Rectal Surgery, Mount Sinai Hospital, New York City, New York, USA.
Te VuongDepartment of Radiation Oncology, Jewish General Hospital, Montreal, Québec, Canada.
Marylise BoutrosDepartment of Colorectal Surgery, Cleveland Clinic Florida, Weston, Florida, USA.ORCID http://orcid.org/0000-0001-8006-321X
Dean A FergussonClinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID http://orcid.org/0000-0002-3389-2485

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWith the rapidly changing landscape of rectal cancer treatment, it is becoming increasingly challenging for clinicians to interpret and synthesise the vast amount of high-quality evidence being generated. A core outcome set (COS) for clinical trials in rectal cancer would help address issues surrounding outcome selection and reporting. The purpose of this research project is to develop a COS to be used in research comparing different treatment paradigms in the management of rectal cancer. METHODS AND ANALYSIS: This will be a mixed-methods project, including a systematic review, semi-structured interviews and a Delphi consensus process. The project was designed in accordance with the COMET (Core Outcome Measures in Effectiveness Trials) Handbook, which provides a framework for COS development based on existing evidence. A multidisciplinary Study Advisory Group, composed of rectal cancer providers, methodologists and patients, will oversee the project. A systematic review will be performed to identify an inclusive list of outcomes reported by researchers in previous rectal cancer trials. Outcomes will be collapsed into various core areas and domains according to the OMERACT Filter V.2.0. Semi-structured interviews with rectal cancer survivors and their partners/caregivers will help identify additional patient-centric outcomes not captured in the systematic review. Finally, after a final list of outcomes is generated, patients and healthcare professionals will be invited to participate in a Delphi process to develop the final COS. ETHICS AND DISSEMINATION: The study has received full approval with the Research Ethics Committee at the Integrated Health and Social Services Network for West-Central Montreal (health network responsible for the Jewish General Hospital) (REC: 2025-4377) and the Institutional Review Board of the Mount Sinai School of Medicine (IRB: STUDY-25-00515). The results of this study will be presented at national and international meetings and a manuscript will be submitted for publication in a high-impact surgery and/or oncology peer-reviewed journal. TRIAL REGISTRATION NUMBER: The study was registered in the COMET database in December 2023 (https://www.comet-initiative.org/Studies/Details/2941). The full systematic review protocol, along with the search strategy and inclusion/exclusion criteria, was registered online in September 2023 (researchregistry.com; reviewregistry1705).

Indexed as

Clinical Trials as TopicOutcome Assessment, Health CareRectal NeoplasmsDelphi TechniqueHumansResearch DesignSystematic Reviews as TopicAdult oncologyColorectal surgeryDelphi Technique

Identifiers

PMID41974548
PMCPMC13084911

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.