Increasing value and reducing waste by optimizing the development of complex interventions: enriching the development phase of the Medical Research Council (MRC) Framework.
Open accessAbstract
BACKGROUND: 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. OBJECTIVE: We therefore propose to enrich the development phase of the MRC Framework by adding crucial elements to improve the likelihood of success and enhance the fit with clinical practice METHODS: Based on existing intervention development guidance and synthesis, a comprehensive iterative intervention development approach is proposed. Examples from published reports are presented to illustrate the methodology that can be applied within each element to enhance the intervention design. RESULTS: A comprehensive iterative approach is presented by combining the elements of the MRC Framework development phase with essential elements from existing guidance including: problem identification, the systematic identification of evidence, identification or development of theory, determination of needs, the examination of current practice and context, modelling the process and expected outcomes leading to final element: the intervention design. All elements are drawn from existing models to provide intervention developers with a greater chance of producing an intervention that is well adopted, effective and fitted to the context. CONCLUSION: This comprehensive approach of developing interventions will strengthen the internal and external validity, minimize research waste and add value to health care research. In complex interventions in health care research, flaws in the development process immediately impact the chances of success. Knowledge regarding the causal mechanisms and interactions within the intended clinical context is needed to develop interventions that fit daily practice and are beneficial for the end-user.
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Bleijenberg et al. suggest using structured methodological frameworks such as Intervention Mapping that fulfills MRC quality criteria on intervention development.
“In order to overcome these shortcomings, Bleijenberg et al. (31) suggest using structured methodological frameworks such as the Intervention Mapping (IM) that fulfills the Medical Research Council’s (MRC) quality criteria on intervention development (31, 32).”
From Developing a mechanism-based therapy for acute psychiatric inpatients with psychotic symptoms: an Intervention Mapping approach (2023) · cites this paper as [31]
The Background and §2.3 propose a systematic approach that combines the MRC development phase with elements of existing intervention-development guidance. The paper cites a book on Intervention Mapping, but our copy does not specifically recommend Intervention Mapping as the framework to use or say that it fulfills MRC quality criteria. (LLM, conf=0.82)
Experimental — accuracy not yet measuredThe PRECEDE-model allowed the synthetization of multi-level data and an in-depth understanding of the situation necessary for identifying evidence-based change mechanisms.
“The PRECEDE-model allowed us the synthetization of multi-level data and an in-depth understanding of our situation necessary for identifying evidence-based change mechanisms (31).”
From Developing a mechanism-based therapy for acute psychiatric inpatients with psychotic symptoms: an Intervention Mapping approach (2023) · cites this paper as [31]
Section 2.3.6 (page unavailable) says modelling can synthesize evidence to identify modifiable determinants and intervention points. The cited paper does not identify the PRECEDE model or show that it enabled the citing authors’ synthesis of multi-level data and understanding of their situation; a search for “PRECEDE” found no matching passage. (LLM, conf=0.78)
Experimental — accuracy not yet measuredAn intervention black box makes it difficult to understand why specific therapy components did not work in a clinical trial.
“An “intervention black box” then makes it difficult to understand why specific therapy components didn’t work in a clinical trial (31).”
From Developing a mechanism-based therapy for acute psychiatric inpatients with psychotic symptoms: an Intervention Mapping approach (2023) · cites this paper as [31]
Neglecting the development phase can lead to inefficient treatments because of poor problem definition, insufficient attention to evidence and context needs, missing model, and unsound selection of change mechanisms.
“Neglecting the actual development phase can be problematic, as a poor problem definition, insufficient attention to existing evidence and context needs, a missing model underlying the intervention, and an unsound selection of hypothesized change mechanisms can lead to inefficient treatments (30–32).”
From Developing a mechanism-based therapy for acute psychiatric inpatients with psychotic symptoms: an Intervention Mapping approach (2023) · cites this paper as [31]
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Cites
Developing and evaluating complex interventions: the new Medical Research Council guidance
Craig, P., Dieppe, P., Macintyre, S., Michie, S., Nazareth, I., & Petticrew, M. (2008) · BMJ · doi:10.1136/bmj.a1655 · Cited by 10,995 · see citing works
Hoffmann, T. C., Glasziou, P. P., Boutron, I., Milne, R., Perera, R., Moher, D., Altman, D. G., Barbour, V., Macdonald, H., Johnston, M., et al. (2014) · BMJ · doi:10.1136/bmj.g1687 · Cited by 10,548 · see citing works
Process evaluation of complex interventions: Medical Research Council guidance
Moore, G. F., Audrey, S., Barker, M., Bond, L., Bonell, C., Hardeman, W., Moore, L., O'Cathain, A., Tinati, T., Wight, D., et al. (2015) · BMJ · doi:10.1136/bmj.h1258 · Cited by 6,204 · see citing works
Avoidable Waste in the Production and Reporting of Research Evidence
Chalmers, I., & Glasziou, P. (2009) · The Lancet · doi:10.1097/aog.0b013e3181c3020d · Cited by 2,136 · see citing works
Planning health promotion programs an intervention mapping approach
Bartholomew, L. K., Parcel, G. S., Kok, G., & Gottlieb, N. (2006) · Cited by 2,038 · see citing works
Planning Health Promotion Programs: An Intervention Mapping Approach
Hicking-Woodison, L. (2017) · Nursing Standard · doi:10.7748/ns.32.6.33.s38 · Cited by 1,843 · see citing works
Increasing value and reducing waste in research design, conduct, and analysis
Ioannidis, J. P. A., Greenland, S., Hlatky, M. A., Khoury, M. J., Macleod, M. R., Moher, D., Schulz, K. F., & Tibshirani, R. (2014) · The Lancet · doi:10.1016/s0140-6736(13)62227-8 · Cited by 1,597 · see citing works
Development of a theory of implementation and integration: Normalization Process Theory
May, C. R., Mair, F., Finch, T., MacFarlane, A., Dowrick, C., Treweek, S., Rapley, T., Ballini, L., Ong, B. N., Rogers, A., et al. (2009) · Implementation Science · doi:10.1186/1748-5908-4-29 · Cited by 1,409 · cited 1× · see citing works
“For example, the Normalization Process Theory (NPT) can help to understand implementation of complex interventions because it focuses on action rather than attitudes (May et al., 2009; May, 2013).”
BackgroundReducing waste from incomplete or unusable reports of biomedical research
Glasziou, P., Altman, D. G., Bossuyt, P., Boutron, I., Clarke, M., Julious, S., Michie, S., Moher, D., & Wager, E. (2014) · The Lancet · doi:10.1016/s0140-6736(13)62228-x · Cited by 1,319 · see citing works
De Silva, M. J., Breuer, E., Lee, L., Asher, L., Chowdhary, N., Lund, C., & Patel, V. (2014) · Trials · doi:10.1186/1745-6215-15-267 · Cited by 738 · see citing works
Lewin, S., Glenton, C., & Oxman, A. D. (2009) · BMJ · doi:10.1136/bmj.b3496 · Cited by 678 · see citing works
Towards a general theory of implementation
May, C. (2013) · Implementation Science · doi:10.1186/1748-5908-8-18 · Cited by 656 · see citing works
Why Most Clinical Research Is Not Useful
Ioannidis, J. P. A. (2016) · PLOS Medicine · doi:10.1371/journal.pmed.1002049 · Cited by 655 · see citing works
Six steps in quality intervention development (6SQuID)
Wight, D., Wimbush, E., Jepson, R., & Doi, L. (2016) · Journal of Epidemiology and Community Health · doi:10.1136/jech-2015-205952 · Cited by 496 · see citing works
Glenton, C., Colvin, C., Carlsen, B., Swartz, A., Lewin, S., Noyes, J., & Rashidian, A. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010414.pub2 · Cited by 454 · see citing works
Complex Interventions in Health
Richards, D. A. (2015) · Routledge eBooks · doi:10.4324/9780203794982 · Cited by 332 · see citing works
Self-citationMöhler, R., Köpke, S., & Meyer, G. (2015) · Trials · doi:10.1186/s13063-015-0709-y · Cited by 317 · see citing works
Do Self-Management Interventions Work in Patients With Heart Failure?
Jonkman, N. H., Westland, H., Groenwold, R. H. H., Ågren, S., Atienza, F., Blue, L., de la Porte, P. W. F. B., DeWalt, D. A., Hebert, P. L., Heisler, M., et al. (2016) · Circulation · doi:10.1161/circulationaha.115.018006 · Cited by 317 · see citing works
Self-citationHardeman, W., Sutton, S., Griffin, S., Johnston, M., White, A., Wareham, N. J., & Kinmonth, A. L. (2005) · Health Education Research · doi:10.1093/her/cyh022 · Cited by 311 · see citing works
Wells, M., Williams, B., Treweek, S., Coyle, J., & Taylor, J. (2012) · Trials · doi:10.1186/1745-6215-13-95 · Cited by 297 · see citing works
Petticrew, M. P., Rehfuess, E. A., Noyes, J., Higgins, J. P. T., Mayhew, A., Tomás Pantoja, C., Shemilt, I., & Sowden, A. J. (2013) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2013.06.005 · Cited by 292 · see citing works
When are complex interventions 'complex'? When are simple interventions 'simple'?
Petticrew, M. P. (2011) · European Journal of Public Health · doi:10.1093/eurpub/ckr084 · Cited by 250 · see citing works
Howick, J., Glasziou, P., & Aronson, J. K. (2009) · Journal of the Royal Society of Medicine · doi:10.1258/jrsm.2009.090020 · Cited by 217 · see citing works
Taking healthcare interventions from trial to practice
Glasziou, P., Chalmers, I., Altman, D. G., Bastian, H., Boutron, I., Brice, A., Jamtvedt, G., Farmer, A., Ghersi, D., Groves, T., et al. (2010) · BMJ · doi:10.1136/bmj.c3852 · Cited by 209 · see citing works
The development of evidence‐based nursing interventions: methodological considerations
van Meijel, B., Gamel, C. J., Swieten-Duijfjes, B. V., & Grypdonck, M. (2004) · Journal of Advanced Nursing · doi:10.1111/j.1365-2648.2004.03171.x · Cited by 166 · see citing works
Chen, Y.-F., Madan, J. J., Welton, N. J., Yahaya, I., Aveyard, P. N., Bauld, L., Wang, D., Fry-Smith, A., & Munafo, M. R. (2012) · Health Technology Assessment · doi:10.3310/hta16380 · Cited by 165 · see citing works
O’Cathain, A., Thomas, K. J., Drabble, S. J., Rudolph, A., Goode, J., & Hewison, J. (2014) · Health Technology Assessment · doi:10.3310/hta18380 · Cited by 159 · see citing works
How to Adapt Effective Programs for Use in New Contexts
Card, J. J., Solomon, J., & Cunningham, S. D. (2009) · Health Promotion Practice · doi:10.1177/1524839909348592 · Cited by 126 · see citing works
The Systematic Development of Nursing Interventions
Whittemore, R., & Grey, M. J. (2002) · Journal of Nursing Scholarship · doi:10.1111/j.1547-5069.2002.00115.x · Cited by 115 · see citing works
Baxter, S. K., Blank, L., Woods, H. B., Payne, N., Rimmer, M., & Goyder, E. (2014) · BMC Medical Research Methodology · doi:10.1186/1471-2288-14-62 · Cited by 114 · see citing works
Mohler, R. A., Bartoszek, G., Köpke, S., & Meyer, G. (2011) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2011.08.003 · Cited by 109 · see citing works
Developing complex interventions for nursing: a critical review of key guidelines
Corry, M., Clarke, M. J., While, A., & Lalor, J. (2013) · Journal of Clinical Nursing · doi:10.1111/jocn.12173 · Cited by 109 · see citing works
Designing effective nursing interventions
Conn, V. S., Rantz, M., Wipke‐Tevis, D. D., & Maas, M. L. (2001) · Research in Nursing & Health · doi:10.1002/nur.1043 · Cited by 102 · see citing works
Barriers and motivators of adherence to prophylactic treatment in haemophilia: a systematic review
Schrijvers, L. H., Uitslager, N., Schuurmans, M. J., & Fischer, K. (2013) · Haemophilia · doi:10.1111/hae.12079 · Cited by 96 · see citing works
Self-citationSoares, M. O., Welton, N. J., Harrison, D. A., Peura, P. K., Shankar‐Hari, M., Harvey, S. E., Madan, J. J., Ades, A. E., Palmer, S., & Rowan, K. (2012) · Health Technology Assessment · doi:10.3310/hta16070 · Cited by 91 · see citing works
How systematic reviews cause research waste
Roberts, I., & Ker, K. (2015) · The Lancet · doi:10.1016/s0140-6736(15)00489-4 · Cited by 83 · see citing works
Searching for the Intervention in Intervention Research Reports
Conn, V. S., Cooper, P. S., Ruppar, T. M., & Russell, C. L. (2008) · Journal of Nursing Scholarship · doi:10.1111/j.1547-5069.2007.00206.x · Cited by 74 · see citing works
Bleijenberg, N., ten Dam, V. H., Drubbel, I., Numans, M. E., de Wit, N. J., & Schuurmans, M. J. (2013) · Journal of Nursing Scholarship · doi:10.1111/jnu.12023 · Cited by 51 · see citing works
Self-citationA systematic review of therapeutic interventions for poststroke depression and the role of nurses
Ginkel, J. M. D. M., Gooskens, F., Schuurmans, M. J., Lindeman, E., Hafsteinsdøttir, T. B., & on Behalf of the Rehabilitation Guideline Stroke Working Group (2010) · Journal of Clinical Nursing · doi:10.1111/j.1365-2702.2010.03402.x · Cited by 48 · see citing works
Self-citationBleijenberg, N., ten Dam, V. H., Steunenberg, B., Drubbel, I., Numans, M. E., de Wit, N. J., & Schuurmans, M. J. (2013) · Journal of Advanced Nursing · doi:10.1111/jan.12110 · Cited by 47 · see citing works
Self-citationEttema, R. G. A., Koeven, H. V., Peelen, L. M., et al. (2013) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2013.05.011 · Cited by 46 · see citing works
Self-citationUnravelling adherence to prophylaxis in haemophilia: a patients’ perspective
Schrijvers, L. H., Kars, M. C., Beijlevelt, M., Peters, M., Schuurmans, M. J., & Fischer, K. (2015) · Haemophilia · doi:10.1111/hae.12660 · Cited by 43 · see citing works
Self-citationDesigning nursing interventions
Aranda, S. K. (2008) · Collegian Journal of the Royal College of Nursing Australia · doi:10.1016/j.colegn.2007.11.002 · Cited by 42 · see citing works
Pregnancy After Miscarriage: Balancing Between Loss of Control and Searching for Control
Ockhuijsen, H. D. L., van den Hoogen, A., Boivin, J., Macklon, N. S., & de Boer, F. (2014) · Research in Nursing & Health · doi:10.1002/nur.21610 · Cited by 33 · see citing works
Ludvigsen, M. S., Meyer, G., Hall, E. O. C., et al. (2013) · Pflege · doi:10.1024/1012-5302/a000292 · Cited by 30 · see citing works
Bleijenberg, N., Boeije, H., Onderwater, A. T., & Schuurmans, M. J. (2015) · Journal of Gerontological Nursing · doi:10.3928/00989134-20150814-03 · Cited by 26 · see citing works
Self-citationStanton, L., & Raftery, J. P. (2011) · Trials · doi:10.1186/1745-6215-12-109 · Cited by 25 · see citing works
Klinke, M. E., Hafsteinsdøttir, T. B., Þorsteinsson, B., & Jónsdóttir, H. (2013) · Journal of Clinical Nursing · doi:10.1111/jocn.12401 · Cited by 21 · see citing works
Ettema, R. G., Hoogendoorn, M. E., Kalkman, C. J., & Schuurmans, M. J. (2014) · European Journal of Cardiovascular Nursing · doi:10.1177/1474515113511715 · Cited by 21 · see citing works
Self-citationModelling process and outcomes in complex interventions
Sermeus, W. (2015) · doi:10.4324/9780203794982-23 · Cited by 14 · see citing works
Research to meet the needs of the NHS: a review of published NIHR HTA clinical trials
Young, A. J., Milne, R., Raftery, J. P., et al. (2011) · Trials · doi:10.1186/1745-6215-12-s1-a86 · Cited by 3 · see citing works
Soares, M., Welton, N. J., Harrison, D. A., et al. (2012) · Cited by 1 · see citing works
Flagged first, then by citations
Research works printed but not linked: 5
- Conn, V.S., Rantz, M.J., Wipke-Tevis, D.D., Maas, M.L., 2001a. Designing effective nur- sing interventions. Res. Nurs. Health 24 (5), 433-442.
- Conn, V.S., Rantz, M.J., Wipke-Tevis, D.D., Maas, M.L., 2001b. Designing effective nur- sing interventions. Res. Nurs. Health 24 (5), 433-442.
- Glasziou, P., Chalmers, I., Altman, D.G., et al., 2010b. Taking healthcare interventions from trial to practice. BMJ 341, c3852. http://dx.doi.org/10.1136/bmj.c3852. · DOI · Paper page
- Richards, D.A., Hallberg, I.R., 2015b. Complex Interventions in Health: An Overview of Research Methods. Routledge.
- WHO, 2001. World Health Organization International Classification of Functioning, Disability and Health. World Health Organization, geneva, pp. 1-303.
Cited by
Sorted by citations
Guidance on how to develop complex interventions to improve health and healthcare
O"Cathain, A., Croot, L., Duncan, E., Rousseau, N., Sworn, K., Turner, K. M., Yardley, L., & Hoddinott, P. (2019) · BMJ Open · doi:10.1136/bmjopen-2019-029954 · Cited by 1,591 · see citing works
Korpershoek, Y. J. G., Hermsen, S., Schoonhoven, L., Schuurmans, M. J., & Trappenburg, J. C. A. (2020) · Journal of Medical Internet Research · doi:10.2196/15449 · Cited by 78 · see citing works
Self-citationSmit, L. C., Dikken, J., Schuurmans, M. J., de Wit, N. J., & Bleijenberg, N. (2020) · BMJ Open · doi:10.1136/bmjopen-2020-039681 · Cited by 42 · see citing works
Self-citationOlafsdottir, S. A., Jonsdottir, H., Bjartmarz, I., Magnusson, C., Caltenco, H., Kytö, M., Maye, L., McGookin, D., Arnadottir, S. A., Hjaltadottir, I., et al. (2020) · BMC Health Services Research · doi:10.1186/s12913-020-05432-x · Cited by 20 · see citing works
Rognsvåg, T., Lindberg, M. F., Lerdal, A., Stubberud, J., Furnes, O., Holm, I., Indrekvam, K., Lau, B., Rudsengen, D., Skou, S. T., et al. (2021) · BMC Health Services Research · doi:10.1186/s12913-021-07177-7 · Cited by 18 · see citing works
Gussmann, E., Lucae, S., Falkai, P., Padberg, F., Egli, S., & Kopf-Beck, J. (2023) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2023.1160075 · Cited by 2 · see citing works
“An “intervention black box” then makes it difficult to understand why specific therapy components didn’t work in a clinical trial (31).”
BackgroundMethodInfluential
- Authors
- Bleijenberg, N., de Man-van Ginkel, J. M., Trappenburg, J. C. A., Ettema, R. G. A., Sino, C. G., Heim, N., Hafsteindóttir, T. B., Richards, D. A., & Schuurmans, M. J.
- Affiliations
- University of Applied Sciences Utrecht (NL)
- Utrecht University (NL)
- University of Exeter (GB)
- Corresponding author
- Bleijenberg, Nienke
- ORCID
- Venue
- International Journal of Nursing Studies
- Publisher
- Elsevier BV
- Published
- 2018-03
- Volume
- 79
- Pages
- 86-93
- ISSN
- 0020-7489 (ISSN-L)
- OpenAlex
- W2771761888
- Cited by
- 334
- References
- 52
- Citations by year
- 2026: 28 · 2025: 34 · 2024: 38 · 2023: 43 · 2022: 70 · 2021: 62 · 2020: 35 · 2019: 20 · 2018: 4
- FWCI
- 26.04
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- International Journal of Nursing Studies (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Open Research Exeter (University of Exeter) (publishedVersion, cc-by-nc-nd)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- Figshare (submittedVersion)
- Funders
- National Institute for Health and Care Research (NF-SI-0514-10037, NF-SI-0611-10203)
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Health Sciences › Health Professions › General Health Professions › Health Sciences Research and Education
- Keywords
- intervention development, complex interventions, MRC framework, research waste, intervention design, needs assessment, contextual analysis, causal mechanisms, research validity, health care research
- MeSH terms
- Waste Management, Biomedical Research
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