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BREATHLEssness in INDIA (BREATHE-INDIA)–Study protocol for the co-design of a community breathlessness intervention in India using realist methods and intervention mapping

Clark, Joseph; Salins, Naveen; Pearson, Mark; Spathis, Anna; Currow, David C.; Williams, Siân; Johnson, Miriam


Naveen Salins

Anna Spathis

David C. Currow

Siân Williams


Background Breathlessness that persists despite treatment of causal disease(s) is disabling, associated with high therapy-related costs and poor socioeconomic outcomes. Low resource countries bear a disproportionate burden of respiratory problems, often characterised by disabling breathlessness. Low-cost self-management breathlessness-targeted interventions are effective and deliverable in community settings but have been developed in high-income countries. We aim to understand how breathlessness self-management works in ‘real life’ populations and cultural contexts, to develop programme theory and co-design a prototype intervention to improve persistent breathlessness management in India. Methods and analysis Using a Realist approach, Intervention Mapping and the Medical Research Council Complex Intervention Framework we will undertake two phases of work supported by our Expert Group (of respiratory, primary, palliative care physicians) and key stakeholder groups (opinion leader clinicians, community health workers and people with lived experiences of breathlessness). 1) Realist review and evaluation to identify and refine evidence and theory for breathlessness self-management, producing intervention and implementation programme theory. We will identify literature through our Expert Group, scoping searches and systematic searches (Medline, Ebscohost, CINAHL, Scopus, Psychinfo). We will map intervention components to ‘what works, for whom, and where.’ 2) Intervention development using Intervention Mapping to map intervention and implementation programme theory to intervention components, develop materials to support intervention delivery, and co-design a prototype educational intervention ready for early acceptability and delivery-feasibility testing and evaluation planning in India. Use of stakeholder groups is to allow people with experience of breathlessness and/or its management to contribute their views on content developed by our team based upon review of secondary data sources. Experts and Stakeholders are therefore not research subjects but are included as extended members of the study team and will not follow informed consent procedures. Experts and stakeholders will be acknowledge in outputs arising from our project if they wish to be. Our review conduct will be consistent with RAMESES quality standards. Discussion At the conclusion of our study, we will have co-designed a breathlessness intervention for use in the community setting in India ready for further evaluation of: effectiveness, socioeconomic outcomes, acceptability and transferability to other low resource settings.


Clark, J., Salins, N., Pearson, M., Spathis, A., Currow, D. C., Williams, S., & Johnson, M. (2023). BREATHLEssness in INDIA (BREATHE-INDIA)–Study protocol for the co-design of a community breathlessness intervention in India using realist methods and intervention mapping. PLoS ONE, 18(11 November), Article e0293918.

Journal Article Type Article
Acceptance Date Oct 21, 2023
Online Publication Date Nov 2, 2023
Publication Date Nov 2, 2023
Deposit Date Jan 20, 2024
Publicly Available Date Jan 23, 2024
Journal PLoS ONE
Print ISSN 1932-6203
Electronic ISSN 1932-6203
Publisher Public Library of Science
Peer Reviewed Peer Reviewed
Volume 18
Issue 11 November
Article Number e0293918
Public URL


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Copyright Statement
Copyright: © 2023 Clark et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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