Liz Steed1, Karen Heslop-Marshall2, Ratna Sohanpal3, Sarah Saqi-Waseem4, Moira Kelly3, Hilary Pinnock5, Stephanie Taylor3. 1. Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK. e.a.steed@qmul.ac.uk. 2. Newcastle upon Tyne NHS Hospitals Foundation Trust, Chest Clinic, New Victoria Wing RVI Hospital, Queen Victoria Road, Newcastle upon Tyne, NE1 4LP, UK. 3. Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK. 4. University College London Hospitals NHS Foundation Trust, 250 Euston Road, NW1 2PG, London, UK. 5. Allergy and Respiratory Research Group, Usher Institute of Population Health Sciences and Informatics, Doorway 3, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.
Abstract
BACKGROUND: Guidelines now call for a thorough and comprehensive description of the development of healthcare interventions to aid evaluation and understanding of the processes of change. This was the primary aim of this study but we also recognised that effective interventions are commonly not implemented in clinical practice. It is suggested that insufficient attention is given to the implementation process at the development phase of interventions. This study outlines the 5 step iterative process we adopted for considering both implementation and effectiveness issues from the outset of intervention development. We use the development of a complex intervention Tailored intervention for ANxiety and DEpression Management (TANDEM) in patients with chronic obstructive pulmonary disease to illustrate this process. METHODS: Intervention development built upon the Medical Research Council framework for developing complex interventions and the person-based approach for development of behavioural interventions. Building an expert team, specifying theory, qualitative data collection and pre-piloting were all critical steps in our intervention development and are described here. RESULTS: Contact with experts in the field, and explicitly building on previous work, ensured efficiency of design. Qualitative work suggested guiding principles for the intervention such as introducing mood in relation to breathlessness, and providing flexible tailoring to patients' needs, whilst implementation principles focused on training selected respiratory professionals and requiring supervision to ensure standards of care. Subsequent steps of intervention development, pre-piloting and intervention refinement led to an intervention that was deemed acceptable and if successful will be ready for implementation. CONCLUSIONS: The TANDEM study was developed efficiently by building on previous work and considering implementation issues from the outset, with the aim that if shown to be effective it will have more rapid translation in to the health care system with accelerated patient benefits. TRIAL REGISTRATION: ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.
BACKGROUND: Guidelines now call for a thorough and comprehensive description of the development of healthcare interventions to aid evaluation and understanding of the processes of change. This was the primary aim of this study but we also recognised that effective interventions are commonly not implemented in clinical practice. It is suggested that insufficient attention is given to the implementation process at the development phase of interventions. This study outlines the 5 step iterative process we adopted for considering both implementation and effectiveness issues from the outset of intervention development. We use the development of a complex intervention Tailored intervention for ANxiety and DEpression Management (TANDEM) in patients with chronic obstructive pulmonary disease to illustrate this process. METHODS: Intervention development built upon the Medical Research Council framework for developing complex interventions and the person-based approach for development of behavioural interventions. Building an expert team, specifying theory, qualitative data collection and pre-piloting were all critical steps in our intervention development and are described here. RESULTS: Contact with experts in the field, and explicitly building on previous work, ensured efficiency of design. Qualitative work suggested guiding principles for the intervention such as introducing mood in relation to breathlessness, and providing flexible tailoring to patients' needs, whilst implementation principles focused on training selected respiratory professionals and requiring supervision to ensure standards of care. Subsequent steps of intervention development, pre-piloting and intervention refinement led to an intervention that was deemed acceptable and if successful will be ready for implementation. CONCLUSIONS: The TANDEM study was developed efficiently by building on previous work and considering implementation issues from the outset, with the aim that if shown to be effective it will have more rapid translation in to the health care system with accelerated patient benefits. TRIAL REGISTRATION: ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.
Authors: Tammy C Hoffmann; Paul P Glasziou; Isabelle Boutron; Ruairidh Milne; Rafael Perera; David Moher; Douglas G Altman; Virginia Barbour; Helen Macdonald; Marie Johnston; Sarah E Lamb; Mary Dixon-Woods; Peter McCulloch; Jeremy C Wyatt; An-Wen Chan; Susan Michie Journal: BMJ Date: 2014-03-07
Authors: Jacob N de Voogd; Johan B Wempe; Klaas Postema; Eric van Sonderen; Adelita V Ranchor; James C Coyne; Robbert Sanderman Journal: Ann Behav Med Date: 2009-10
Authors: Sergi Blancafort Alias; César Cuevas-Lara; Nicolás Martínez-Velilla; Fabricio Zambom-Ferraresi; Maria Eugenia Soto; Neda Tavassoli; Céline Mathieu; Eva Heras Muxella; Pablo Garibaldi; Maria Anglada; Jordi Amblàs; Sebastià Santaeugènia; Joan Carles Contel; Àlex Domingo; Antoni Salvà Casanovas Journal: Int J Environ Res Public Health Date: 2021-06-02 Impact factor: 3.390