Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys

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Abstract

Background

There are numerous challenges in including patients in a core outcome set (COS) study, these can vary depending on the patient group. This study describes current efforts to include patients in the development of COS, with the aim of identifying areas for further improvement and study.

Methods

Using the COMET database, corresponding authors of COS projects registered or published from 1 January 2013 to 2 February 2017 were invited via a personalised email to participate in a short online survey. The survey and emails were constructed to maximise the response rate by following the academic literature on enhancing survey responses. Personalised reminder emails were sent to non-responders. This survey explored the frequency of patient input in COS studies, who was involved, what methods were used and whether or not the COS development was international.

Results

One hundred and ninety-two COS developers were sent the survey. Responses were collected from 21 February 2017 until 7 May 2017. One hundred and forty-six unique developers responded, yielding a 76% response rate and data in relation to 195 unique COSs (as some developers had worked on multiple COSs). Of focus here are their responses regarding 162 COSs at the published, completed or ongoing stages of development. Inclusion of patient participants was indicated in 87% (141/162) of COSs in the published completed or ongoing stages and over 94% (65/69) of ongoing COS projects. Nearly half (65/135) of COSs included patient participants from two or more countries and 22% (30/135) included patient participants from five or more countries. The Delphi survey was reported as being used singularly or in combination with other methods in 85% (119/140) of projects. Almost a quarter (16/65) of ongoing studies reported using a combination of qualitative interviews, Delphi survey and consensus meeting.

Conclusions

These findings indicated that the Delphi survey is the most popular method of facilitating patient participation, while the combination of qualitative interviews, Delphi survey and consensus meetings is the most popular combination of methods. The increased inclusion of patient participants in the development of COSs is encouraging, as is the international approach to COS development that some developers are adopting.

Electronic supplementary material

The online version of this article (10.1186/s13063-018-2493-y) contains supplementary material, which is available to authorized users.

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Most cited references 12

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Core Outcome Set-STAndards for Development: The COS-STAD recommendations

Jamie Kirkham, Katherine Davis, Douglas G. Altman … (2017)

Background The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR]). Methods and findings An international group of experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives produced the COS-STAD recommendations to help improve the quality of COS development and support the assessment of whether a COS had been developed using a reasonable approach. An open survey of experts generated an initial list of items, which was refined by a 2-round Delphi survey involving nearly 250 participants representing key stakeholder groups. Participants assigned importance ratings for each item using a 1–9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. The Delphi survey was followed by a consensus discussion with the study management group representing multiple stakeholder groups. COS-STAD contains 11 minimum standards that are the minimum design recommendations for all COS development projects. The recommendations focus on 3 key domains: the scope, the stakeholders, and the consensus process. Conclusions The COS-STAD project has established 11 minimum standards to be followed by COS developers when planning their projects and by users when deciding whether a COS has been developed using reasonable methods.

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Choosing Important Health Outcomes for Comparative Effectiveness Research: A Systematic Review

Elizabeth Gargon, Binu Gurung, Nancy Medley … (2014)

Background A core outcome set (COS) is a standardised set of outcomes which should be measured and reported, as a minimum, in all effectiveness trials for a specific health area. This will allow results of studies to be compared, contrasted and combined as appropriate, as well as ensuring that all trials contribute usable information. The COMET (Core Outcome Measures for Effectiveness Trials) Initiative aims to support the development, reporting and adoption of COS. Central to this is a publically accessible online resource, populated with all available COS. The aim of the review we report here was to identify studies that sought to determine which outcomes or domains to measure in all clinical trials in a specific condition and to describe the methodological techniques used in these studies. Methods We developed a multi-faceted search strategy for electronic databases (MEDLINE, SCOPUS, and Cochrane Methodology Register). We included studies that sought to determine which outcomes/domains to measure in all clinical trials in a specific condition. Results A total of 250 reports relating to 198 studies were judged eligible for inclusion in the review. Studies covered various areas of health, most commonly cancer, rheumatology, neurology, heart and circulation, and dentistry and oral health. A variety of methods have been used to develop COS, including semi-structured discussion, unstructured group discussion, the Delphi Technique, Consensus Development Conference, surveys and Nominal Group Technique. The most common groups involved were clinical experts and non-clinical research experts. Thirty-one (16%) studies reported that the public had been involved in the process. The geographic locations of participants were predominantly North America (n = 164; 83%) and Europe (n = 150; 76%). Conclusions This systematic review identified many health areas where a COS has been developed, but also highlights important gaps. It is a further step towards a comprehensive, up-to-date database of COS. In addition, it shows the need for methodological guidance, including how to engage key stakeholder groups, particularly members of the public.

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Driving up the quality and relevance of research through the use of agreed core outcomes.

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

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Author and article information

Contributors

Alice M. Biggane: abiggane@liverpool.ac.uk

Lucy Brading: lbrading@liverpool.ac.uk

Philippe Ravaud: philippe.ravaud@aphp.fr

Bridget Young: Bridget.Young@liverpool.ac.uk

Paula R. Williamson: prw@liverpool.ac.uk

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 17 February 2018

Publication date PMC-release: 17 February 2018

Publication date Collection: 2018

Volume: 19

Electronic Location Identifier: 113

Affiliations

[1 ]ISNI 0000 0004 1936 8470, GRID grid.10025.36, Department of Biostatistics, , University of Liverpool, ; Liverpool, UK

[2 ]ISNI 0000000121866389, GRID grid.7429.8, INSERM, U1153 Epidemiology and Biostatistics Sorbonne Paris Cité Research Center (CRESS), Methods of therapeutic evaluation of chronic diseases Team (METHODS), ; 75014 Paris, France

[3 ]ISNI 0000 0001 2188 0914, GRID grid.10992.33, Paris Descartes University, Sorbonne Paris Cité, ; Paris, France

[4 ]ISNI 0000 0004 1936 8470, GRID grid.10025.36, Institute of Psychology Health and Society/North West Hub for Trials Methodology Research, , University of Liverpool, ; Liverpool, UK

[5 ]ISNI 0000000121866389, GRID grid.7429.8, Centre de Recherche Epidémiologie et Statistique, INSERM U1153, ; Paris, France

[6 ]Cochrane France, Paris, France

[7 ]Centre d’Épidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris, 75004 Paris, France

[8 ]ISNI 0000000419368729, GRID grid.21729.3f, Department of Epidemiology, Mailman School of Public Health, , Columbia University, ; New York, NY USA

[9 ]ISNI 0000 0004 1936 8470, GRID grid.10025.36, Department of Psychological Sciences and MRC North West Hub for Trials Methodology Research, , University of Liverpool, ; Liverpool, UK

[10 ]ISNI 0000 0004 1936 8470, GRID grid.10025.36, MRC North West Hub for Trials Methodology Research, Department of Biostatistics, , University of Liverpool, ; Liverpool, UK

Article

Publisher ID: 2493

DOI: 10.1186/s13063-018-2493-y

PMC ID: 5816387

PubMed ID: 29454368

SO-VID: ec69dfd3-bd0c-4985-9932-8b2cdb79c989

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 12 October 2017

Date accepted : 22 January 2018

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100010665, H2020 Marie Skłodowska-Curie Actions;

Award ID: 676207

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: delphi,survey,patient engagement,patient participation,core outcome sets

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ScienceOpen disciplines: Medicine

Keywords: delphi, survey, patient engagement, patient participation, core outcome sets

Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys

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Abstract

Background

Methods

Results

Conclusions

Electronic supplementary material

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European Yearbook of the History of Psychology

Most cited references 12

Core Outcome Set-STAndards for Development: The COS-STAD recommendations

Choosing Important Health Outcomes for Comparative Effectiveness Research: A Systematic Review

Driving up the quality and relevance of research through the use of agreed core outcomes.

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