Developing and evaluating complex interventions: updating medical Research Council guidance to take account of new methodological and theoretical approaches
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An explicit focus on implementation and economic aspects early during treatment development has been recommended.
“An explicit focus on implementation and economic aspects early during treatment development has been recommended.44 45”
From Development, evaluation and implementation of a digital behavioural health treatment for chronic pain: study protocol of the multiphase DAHLIA project (2022) · cites this paper as [45]
The DAHLIA approach is in line with the widely used MRC/NIHR framework by considering contextual and economical aspects, building on theory, involving stakeholders, and refining the intervention.
“The DAHLIA approach is also in line with the widely used MRC/NIHR framework by considering contextual and economical aspects, building on theory, involving stakeholders, and refining the intervention.26 45”
From Development, evaluation and implementation of a digital behavioural health treatment for chronic pain: study protocol of the multiphase DAHLIA project (2022) · cites this paper as [45]
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“The latest draft of the MRC’s guidelines for the development of complex interventions suggests realist evaluation for questions related to how context influences interventions and what ‘unseen mechanisms’ are involved in making an intervention work (21).”
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“Such factors are important to consider when conducting a literature search and review as part of developing complex interventions [29].”
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“26 45 Due to the ambitious and multifaceted nature of the project, several inherent challenges and risks should also be acknowledged.”
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“The Medical Research Council (MRC) has introduced a framework for the development of complex interventions through to evaluation and implementation, with new updated guidance soon to be published in the imminent future.(44,45) It details how interventions should be evidence based with the use of 2 DIGITAL HEALTH”
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“According to the UK Medical Research Council framework, pilot testing is a prerequisite for the success of an intervention [40].”
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“The complexity resides in the variety of behaviours required by participants in the intervention, the groups or organisational levels targeted, the potentially large number of outcomes and the degree of flexibility permitted by the intervention [3], all of which are associated with emergent phenomena that are difficul…”
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“Including logic model as part of the process evaluation would also assist in mapping the range of factors that contribute to changes in intervention outcomes.”
Drewelow, E., Ritzke, M., Altiner, A., Icks, A., Montalbo, J., Kalitzkus, V., Löscher, S., Pashutina, Y., Fleischer, S., Abraham, J., et al. (2022) · PEC Innovation · doi:10.1016/j.pecinn.2022.100032 · Cited by 12 · see citing works
“This process was conducted according to the first two stages of the Medical Research Council (MRC) framework by Craig [16] and its further development [17,18].”
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“The intervention development and following feasibility study also followed the revised MRC Framework for Complex Interventions [22] and guidance on developing complex interventions [23].”
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Reeve, J., & Cheon, S. H. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.035 · Cited by 9 · see citing works
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“A causal link between an exposure (e.g., to some feature of an intervention) and an outcome [14] Moderator—Factor that increases or decreases the level of influence of an intervention or strategy, for example, connectivity within the organisational network structure [17] Motivation – “all those…”
BackgroundMethodInfluentialEvaluation of Behavior Change Interventions
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BackgroundMethodDoren, S. V., Hermans, K., & Declercq, A. (2021) · BMC Health Services Research · doi:10.1186/s12913-021-06453-w · Cited by 7 · see citing works
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“Indeed, it is increasingly questioned whether RCTs are appropriate in the field of OHM [32, 43].”
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Addressing Underserved Populations and Disparities in Behavior Change
Schüz, B., & Hooper, M. W. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.027 · Cited by 5 · see citing works
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Ahern, M., Dean, C. M., Dear, B. F., Willcock, S., & Hush, J. M. (2022) · Australian Journal of Primary Health · doi:10.1071/py21206 · Cited by 5 · see citing works
Changing Behavior in the Digital Age
Kavanagh, D. J. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108677318.029 · Cited by 4 · see citing works
Armitage, S., McColl, E., Kolehmainen, N., & Rapley, T. (2020) · Health Expectations · doi:10.1111/hex.13180 · Cited by 4 · see citing works
Cordero, J., Mochache, V., Boydell, V., Addah, M. A., McMullen, H., Monyo, A., Mrema, S., Nai, D., Shamba, D., & Steyn, P. (2022) · International Journal for Equity in Health · doi:10.1186/s12939-022-01718-0 · Cited by 3 · see citing works
“There have been calls to move away from the view that experimental designs are the only approach and that RCTs generate the best quality evidence [30, 31].”
Lin, R. S. Y., Yu, D. S. F., Chau, P. H., & Li, P. W. C. (2021) · Journal of Advanced Nursing · doi:10.1111/jan.14871 · Cited by 4 · see citing works
Battel, I., Arienti, C., Levack, W., Kiekens, C., & Négrini, S. (2024) · Cochrane Evidence Synthesis and Methods · doi:10.1002/cesm.70000 · Cited by 3 · see citing works
“…delivering and receiving the intervention, as well as the degree of collaboration and adherence to the intervention; the number of cycles and levels of the process; the different settings; and/or the permitted level of flexibility in the delivery of the intervention or its components [10, 18, 23].”
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“The interventions included in this study are complex in character [42].”
MethodFlood, M., Gleeson, L. L., Flynn, S. M., Ennis, M., Ludlow, A., Sweeney, F. F., Holton, A. E., Morgan, S., Clarke, C., Carroll, P., et al. (2022) · Elsevier eBooks · doi:10.1016/b978-0-323-91888-6.00011-9 · Cited by 3 · see citing works
- Authors
- Skivington, K., Matthews, L., Craig, P., Simpson, S., & Moore, L.
- Affiliations
- University of Glasgow (GB)
- Corresponding author
- Skivington, Kathryn
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2018-11
- Volume
- 392
- Pages
- S2
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2900704124
- Cited by
- 137
- References
- 0
- Citations by year
- 2026: 4 · 2025: 5 · 2024: 8 · 2023: 7 · 2022: 14 · 2021: 21 · 2020: 68 · 2019: 8
- FWCI
- 37.19
- Type
- journal article
- Language
- en
- Open access
- green
- eprints.gla.ac.uk
- Licence
- Locations
- The Lancet (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion, cc-by-sa)
- Funders
- MRC Strategic Award (MC_PC_13027)
- CSO programme grants (MC_UU_12017/14, SPHSU14, MC_UU_12017/15, SPHSU15)
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Social Sciences › Decision Sciences › Management Science and Operations Research › Evaluation and Performance Assessment
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- complex interventions, complex systems science, program theory, natural experiment, research prioritization, intervention development
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