Systematic review of international Delphi surveys for core outcome set development: representation of international patients

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Abstract

Objectives

A core outcome set (COS) describes a minimum set of outcomes to be reported by all clinical trials of one healthcare condition. Delphi surveys are frequently used to achieve consensus on core outcomes. International input is important to achieve global COS uptake. We aimed to investigate participant representation in international Delphi surveys, with reference to the inclusion of patients and participants from low and middle income countries as stakeholders (LMICs).

Design

Systematic review.

Data sources

EMBASE, Medline, Web of Science, COMET database and hand-searching.

Eligibility criteria

Protocols and studies describing Delphi surveys used to develop an international COS for trial reporting, published between 1 January 2017 and 6 June 2019.

Data extraction and synthesis

Delphi participants were grouped as patients or healthcare professionals (HCPs). Participants were considered international if their country of origin was different to that of the first or senior author. Data extraction included participant numbers, country of origin, country income group and whether Delphi surveys were translated. We analysed the impact these factors had on outcome prioritisation.

Results

Of 90 included studies, 69% (n=62) were completed and 31% (n=28) were protocols. Studies recruited more HCPs than patients (median 60 (IQR 30–113) vs 30 (IQR 14–66) participants, respectively). A higher percentage of HCPs was international compared with patients (57% (IQR 37–78) vs 20% (IQR 0–68)). Only 31% (n=28) studies recruited participants from LMICs. Regarding recruitment from LMICs, patients were under-represented (16% studies; n=8) compared with HCPs (22%; n=28). Few (7%; n=6) studies translated Delphi surveys. Only 3% studies (n=3) analysed Delphi responses by geographical location; all found differences in outcome prioritisation.

Conclusions

There is a disproportionately lower inclusion of international patients, compared with HCPs, in COS-development Delphi surveys, particularly within LMICs. Future international Delphi surveys should consider exploring for geographical and income-based differences in outcome prioritisation.

PROSPERO registration number

CRD42019138519.

Related collections

Most cited references 106

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The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration.

Alessandro Liberati, Douglas G. Altman, Jennifer Tetzlaff … (2009)

Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement--a reporting guideline published in 1999--there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.

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The COMET Handbook: version 1.0

Paula Williamson, Douglas G. Altman, Heather Bagley … (2017)

The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1978-4) contains supplementary material, which is available to authorized users.

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Developing core outcome sets for clinical trials: issues to consider

Paula Williamson, Douglas G. Altman, Jane Blazeby … (2012)

The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2020

Publication date (Electronic): 23 November 2020

Volume: 10

Issue: 11

Electronic Location Identifier: e040223

Affiliations

[1 ] departmentAcademic Foundation Doctor, Department of Surgery and Cancer , Imperial College London , London, UK

[2 ] departmentSenior Research Fellow, Centre for Academic Child Health , University of Bristol , Bristol, UK

[3 ] departmentConsultant Paediatric Anaesthetist and Lead Children's Burns Research Centre , University Hospitals Bristol NHS Foundation Trust , Bristol, UK

[4 ] departmentSenior Research Fellow , Bristol Centre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol , Bristol, UK

Author notes

[Correspondence to ] Dr Amber E Young; amber.young1@ 123456nhs.net

Author information

Alice Lee http://orcid.org/0000-0002-8492-837X

Amber E Young http://orcid.org/0000-0001-7205-492X

Article

Publisher ID: bmjopen-2020-040223

DOI: 10.1136/bmjopen-2020-040223

PMC ID: 7684826

PubMed ID: 33234639

SO-VID: acf35669-0202-4ef5-9967-4603feff65b3

License:

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 07 May 2020

Date revision received : 20 August 2020

Date accepted : 06 October 2020

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special-feature unlocked

ScienceOpen disciplines: Medicine

Keywords: delphi,core outcome set,patient and public involvement,low and middle income countries,international

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ScienceOpen disciplines: Medicine

Keywords: delphi, core outcome set, patient and public involvement, low and middle income countries, international

Systematic review of international Delphi surveys for core outcome set development: representation of international patients

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Abstract

Objectives

Design

Data sources

Eligibility criteria

Data extraction and synthesis

Results

Conclusions

PROSPERO registration number

Related collections

The International Journal of Person Centered Medicine

Most cited references 106

The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration.

The COMET Handbook: version 1.0

Developing core outcome sets for clinical trials: issues to consider

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