Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study

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Abstract

Objective

To improve the quality and consistency of intervention development reporting in health research.

Design

This was a consensus exercise consisting of two simultaneous and identical three-round e-Delphi studies (one with experts in intervention development and one with wider stakeholders including funders, journal editors and public involvement members), followed by a consensus workshop. Delphi items were systematically derived from two preceding systematic reviews and a qualitative interview study.

Participants

Intervention developers (n=26) and wider stakeholders (n=18) from the UK, North America and Europe participated in separate e-Delphi studies. Intervention developers (n=13) and wider stakeholders (n=13) participated in a 1-day consensus workshop.

Results

e-Delphi participants achieved consensus on 15 reporting items. Following feedback from the consensus meeting, the final inclusion and wording of 14 items with description and explanations for each item were agreed. Items focus on context, purpose, target population, approaches, evidence, theory, guiding principles, stakeholder contribution, changes in content or format during the development process, required changes for subgroups, continuing uncertainties, and open access publication. They form the GUIDED (GUIDance for the rEporting of intervention Development) checklist, which contains a description and explanation of each item, alongside examples of good reporting.

Conclusions

Consensus-based reporting guidance for intervention development in health research is now available for publishers and researchers to use. GUIDED has the potential to lead to greater transparency, and enhance quality and improve learning about intervention development research and practice.

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Guidance on how to develop complex interventions to improve health and healthcare

Alicia O'Cathain, Liz Croot, Edward Duncan … (2019)

Objective To provide researchers with guidance on actions to take during intervention development. Summary of key points Based on a consensus exercise informed by reviews and qualitative interviews, we present key principles and actions for consideration when developing interventions to improve health. These include seeing intervention development as a dynamic iterative process, involving stakeholders, reviewing published research evidence, drawing on existing theories, articulating programme theory, undertaking primary data collection, understanding context, paying attention to future implementation in the real world and designing and refining an intervention using iterative cycles of development with stakeholder input throughout. Conclusion Researchers should consider each action by addressing its relevance to a specific intervention in a specific context, both at the start and throughout the development process.

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GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research

S Staniszewska, J. Brett, I Simera … (2017)

Background While the patient and public involvement (PPI) evidence base has expanded over the past decade, the quality of reporting within papers is often inconsistent, limiting our understanding of how it works, in what context, for whom, and why. Objective To develop international consensus on the key items to report to enhance the quality, transparency, and consistency of the PPI evidence base. To collaboratively involve patients as research partners at all stages in the development of GRIPP2. Methods The EQUATOR method for developing reporting guidelines was used. The original GRIPP (Guidance for Reporting Involvement of Patients and the Public) checklist was revised, based on updated systematic review evidence. A three round Delphi survey was used to develop consensus on items to be included in the guideline. A subsequent face-to-face meeting produced agreement on items not reaching consensus during the Delphi process. Results One hundred forty-three participants agreed to participate in round one, with an 86% (123/143) response for round two and a 78% (112/143) response for round three. The Delphi survey identified the need for long form (LF) and short form (SF) versions. GRIPP2-LF includes 34 items on aims, definitions, concepts and theory, methods, stages and nature of involvement, context, capture or measurement of impact, outcomes, economic assessment, and reflections and is suitable for studies where the main focus is PPI. GRIPP2-SF includes five items on aims, methods, results, outcomes, and critical perspective and is suitable for studies where PPI is a secondary focus. Conclusions GRIPP2-LF and GRIPP2-SF represent the first international evidence based, consensus informed guidance for reporting patient and public involvement in research. Both versions of GRIPP2 aim to improve the quality, transparency, and consistency of the international PPI evidence base, to ensure PPI practice is based on the best evidence. In order to encourage its wide dissemination this article is freely accessible on The BMJ and Research Involvement and Engagement journal websites. Electronic supplementary material The online version of this article (doi:10.1186/s40900-017-0062-2) contains supplementary material, which is available to authorized users.

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Six steps in quality intervention development (6SQuID)

Daniel Wight, Erica Wimbush, Ruth Jepson … (2015)

Improving the effectiveness of public health interventions relies as much on the attention paid to their design and feasibility as to their evaluation. Yet, compared to the vast literature on how to evaluate interventions, there is little to guide researchers or practitioners on how best to develop such interventions in practical, logical, evidence based ways to maximise likely effectiveness. Existing models for the development of public health interventions tend to have a strong social-psychological, individual behaviour change orientation and some take years to implement. This paper presents a pragmatic guide to six essential Steps for Quality Intervention Development (6SQuID). The focus is on public health interventions but the model should have wider applicability. Once a problem has been identified as needing intervention, the process of designing an intervention can be broken down into six crucial steps: (1) defining and understanding the problem and its causes; (2) identifying which causal or contextual factors are modifiable: which have the greatest scope for change and who would benefit most; (3) deciding on the mechanisms of change; (4) clarifying how these will be delivered; (5) testing and adapting the intervention; and (6) collecting sufficient evidence of effectiveness to proceed to a rigorous evaluation. If each of these steps is carefully addressed, better use will be made of scarce public resources by avoiding the costly evaluation, or implementation, of unpromising interventions.

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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): 8 April 2020

Volume: 10

Issue: 4

Electronic Location Identifier: e033516

Affiliations

[1 ]departmentNursing, Midwifery and Allied Health Professional Research Unit , University of Stirling , Stirling, UK

[2 ]departmentSchool of Health and Related Research , University of Sheffield , Sheffield, UK

[3 ]departmentLeeds Institute of Clinical Trials, School of Medicine , University of Leeds , Leeds, UK

[4 ]departmentHealth Economics and Decision Science, School of Health and Related Research , University of Sheffield , Sheffield, UK

[5 ]departmentBristol Medical School , University of Bristol , Bristol, UK

[6 ]departmentPsychology , University of Southampton , Southampton, UK

[7 ]departmentSchool of Health Sciences , University of Bristol , Bristol, UK

Author notes

[Correspondence to ] Dr Edward Duncan; edward.duncan@ 123456stir.ac.uk

Author information

Edward Duncan http://orcid.org/0000-0002-3400-905X

Alicia O'Cathain http://orcid.org/0000-0003-4033-506X

Katrina M Turner http://orcid.org/0000-0002-6375-2918

Pat Hoddinott http://orcid.org/0000-0002-4372-9681

Article

Publisher ID: bmjopen-2019-033516

DOI: 10.1136/bmjopen-2019-033516

PMC ID: 7245409

PubMed ID: 32273313

SO-VID: 177c1c0c-7de8-4be5-a427-75aeba1426b7

License:

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

History

Date received : 08 August 2019

Date revision received : 10 January 2020

Date accepted : 19 February 2020

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100000265, Medical Research Council;

Award ID: MR/N015339/1

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ScienceOpen disciplines: Medicine

Keywords: intervention development,reporting guidance,delphi,consensus

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ScienceOpen disciplines: Medicine

Keywords: intervention development, reporting guidance, delphi, consensus

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Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study

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Most cited references 34

Guidance on how to develop complex interventions to improve health and healthcare

GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research

Six steps in quality intervention development (6SQuID)

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Cited by 109

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