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

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          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          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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          Most cited references8

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          Taxonomy of approaches to developing interventions to improve health: a systematic methods overview

          Alicia O’Cathain, Liz Croot, Katie Sworn … (2019)
          Background Interventions need to be developed prior to the feasibility and piloting phase of a study. There are a variety of published approaches to developing interventions, programmes or innovations to improve health. Identifying different types of approach, and synthesising the range of actions taken within this endeavour, can inform future intervention development. Methods This study is a systematic methods overview of approaches to intervention development. Approaches were considered for inclusion if they described how to develop or adapt an intervention in a book, website or journal article published after 2007, or were cited in a primary research study reporting the development of a specific intervention published in 2015 or 2016. Approaches were read, a taxonomy of approaches was developed and the range of actions taken across different approaches were synthesised. Results Eight categories of approach to intervention development were identified. (1) Partnership, where people who will use the intervention participate equally with the research team in decision-making about the intervention throughout the development process. (2) Target population-centred, where the intervention is based on the views and actions of the people who will use it. (3) Evidence and theory-based, where the intervention is based on published research evidence and existing theories. (4) Implementation-based, where the intervention is developed with attention to ensuring it will be used in the real world. (5) Efficiency-based, where components of an intervention are tested using experimental designs to select components which will optimise efficiency. (6) Stepped or phased, where interventions are developed with an emphasis on following a systematic set of processes. (7) Intervention-specific, where an approach is constructed for a specific type of intervention. (8) Combination, where existing approaches to intervention development are formally combined. The actions from approaches in all eight categories were synthesised to identify 18 actions to consider when developing interventions. Conclusions This overview of approaches to intervention development can help researchers to understand the variety of existing approaches, and to understand the range of possible actions involved in intervention development, prior to assessing feasibility or piloting the intervention. Findings from this overview will contribute to future guidance on intervention development. Trial registration PROSPERO CRD42017080553. Electronic supplementary material The online version of this article (10.1186/s40814-019-0425-6) contains supplementary material, which is available to authorized users.
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            A Description of Think Aloud Method and Protocol Analysis

            M. Fonteyn, B Kuipers, S. Grobe (1993)
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              Increasing value and reducing waste by optimizing the development of complex interventions: Enriching the development phase of the Medical Research Council (MRC) Framework

              Marieke J Schuurmans, David Richards, Thóra B. Hafsteindóttir … (2018)
              In recent years there has been much emphasis on 'research waste' caused by poor question selection, insufficient attention to previous research results, and avoidable weakness in research design, conduct and analysis. Little attention has been paid to the effect of inadequate development of interventions before proceeding to a full clinical trial.
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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: 2019
                Publication date (Electronic): 15 August 2019
                Volume: 9
                Issue: 8
                Electronic Location Identifier: e029954
                Affiliations
                [1 ] departmentMedical Care Research Unit, School of Health and Related Research , University of Sheffield , Sheffield, UK
                [2 ] departmentNursing, Midwifery and Allied Health Professional Research Unit , University of Stirling , Stirling, UK
                [3 ] departmentSchool of Social and Community Medicine , University of Bristol , Bristol, UK
                [4 ] departmentPsychology , University of Southampton , Southampton, UK
                Author notes
                [Correspondence to ] Professor Alicia O'Cathain; a.ocathain@ 123456sheffield.ac.uk
                Author information
                http://orcid.org/0000-0003-4033-506X
                http://orcid.org/0000-0002-3666-6264
                http://orcid.org/0000-0002-3400-905X
                http://orcid.org/0000-0002-6375-2918
                http://orcid.org/0000-0002-4372-9681
                Article
                Publisher ID: bmjopen-2019-029954
                DOI: 10.1136/bmjopen-2019-029954
                PMC ID: 6701588
                PubMed ID: 31420394
                SO-VID: 9d71ca71-add4-4587-adb6-60f3b60958d9
                Copyright © © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.
                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 : 19 February 2019
                Date revision received : 27 June 2019
                Date accepted : 15 July 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000265, Medical Research Council;
                Award ID: MR/N015339/1
                Categories
                Subject: Research Methods
                Subject: Communication
                Subject: 1506
                Custom metadata
                special-feature unlocked

                ScienceOpen disciplines: Medicine
                Keywords: guidance,health,intervention development
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: guidance, health, intervention development

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