INDEX Study

(IdentifyiNg and assessing different approaches to DEveloping compleX interventions)


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Summary


The aim of this study is to produce guidance for researchers on how to develop complex interventions to improve health or health care outcomes. The objectives are to: 1. Identify and describe the different approaches taken to intervention development, the rationales for their use, and any implications for the future utility of the interventions. 2. Compare and contrast different intervention development approaches, the methods of data collection and analysis they used, considering strengths and limitations overall and for different contexts. 3. Understand the history and challenges of intervention development from the perspectives of experienced researchers and wider stakeholders e.g. research funders, public and patient representatives. 4. Measure stakeholder consensus on the key aspects of intervention development and explore the reasons for any lack of consensus. 5. Offer guidance to researchers on good practice, with examples from different approaches.

The design is a sequential mixed methods study in 3 phases. In phase 1 we will undertake three systematic reviews of literature on intervention development. The first will identify different approaches and methods in primary intervention research and expert description and critiques. The second will be an in-depth analysis of the application of primary intervention development research to improve health or health care outcomes. The third will be a review of a sample of successful interventions and the intervention development approaches they used. In phase 2 we will identify the challenges of intervention development in a qualitative interview study, and consider with stakeholders how to bring together the learning from our data collection. In phase 3 we will undertake a consensus exercise to identify core aspects of intervention development.


Objectives

The aim is to produce guidance for researchers on how to develop complex interventions to improve health or health care outcomes. The objectives are to:

1. Identify and describe the different approaches taken to intervention development, the rationales for their use, and any implications for the future utility of the interventions.

2. Compare and contrast different intervention development approaches, and their methods of data collection and analysis, considering strengths and limitations overall and for different contexts.

3. Understand the history and challenges of intervention development from the perspectives of experienced researchers and wider stakeholders.

4. Measure stakeholder consensus on the key aspects of intervention development and explore the reasons for any lack of consensus.

5. Offer guidance to researchers on good practice, with examples from different approaches.


Ethics and research governance

NHS Ethics approval is not necessary because no patients will be interviewed. All documentation in the review will be in the public domain. We will apply to the University of Sheffield ethics committee to ensure that any ethical or governance issues relevant to the study are identified and adhered to.


Sponsor


MRC logo


Team


PI: prof. Alicia O’Cathain – University of Sheffield

Co-applicants:   

dr. Elizabeth Croot – University of Sheffield
dr. Edward Duncan – University of Stirling
prof. Pat Hoddinott – University of Stirling
prof. Lucy Yardley – University of Southampton   
dr. Katrina Turner - University of Bristol

University of Stirling Researcher: dr. Nikki Rousseau

University of Sheffield Researcher: dr. Katie Sworn

Administrative Assistant: Veronica Fibisan – Sheffield

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Timetable

Period Stage
Apr-Dec 2016 Ethics application
Undertake data collection for reviews
Apr -Mar 2017 Early qualitative interviews
Preliminary typology development
Sept -Mar 2017 Data extraction from review
May 2017 Stakeholder workshop
Apr 2017 - Aug 2017 Analysis of review data
Mar 2017 - Jan 2018 Further qualitative interviews and analysis
July-Jan 2018 eDelphi x 2
Dec 2018 Consensus Implementation Workshop
Feb-Mar 2018 Production of guidance and dissemination
Mar 2018 Impact workshop


For further details about this study, please contact Veronica Fibisan, administrator assistant at v.fibisan@sheffield.ac.uk.