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A rational model for assessing and evaluating complex interventions in health care
Open accessAbstract
BACKGROUND: Understanding how new clinical techniques, technologies and other complex interventions become normalized in practice is important to researchers, clinicians, health service managers and policy-makers. This paper presents a model of the normalization of complex interventions. METHODS: Between 1995 and 2005 multiple qualitative studies were undertaken. These examined: professional-patient relationships; changing patterns of care; the development, evaluation and implementation of telemedicine and related informatics systems; and the production and utilization of evidence for practice. Data from these studies were subjected to (i) formative re-analysis, leading to sets of analytic propositions; and to (ii) a summative analysis that aimed to build a robust conceptual model of the normalization of complex interventions in health care. RESULTS: A normalization process model that enables analysis of the conditions necessary to support the introduction of complex interventions is presented. The model is defined by four constructs: interactional workability; relational integration; skill set workability and contextual integration. This model can be used to understand the normalization potential of new techniques and technologies in healthcare settings CONCLUSION: The normalization process model has face validity in (i) assessing the potential for complex interventions to become routinely embedded in everyday clinical work, and (ii) evaluating the factors that promote or inhibit their success and failure in practice.
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In the citing paper
“A selection of approaches took a wider perspective and looked at whether the initiative benefits were perceived by staff and other stakeholders as valuable [8, 30, 42, 51, 61-63].”
From Navigating the sustainability landscape: a systematic review of sustainability approaches in healthcare (2018) · cites this paper as [51]
In the citing paper
“As an applied theoretical model, the NPM was restricted to a specific field of activity: the operationalization of complex healthcare interventions [7].”
From Development of a theory of implementation and integration: Normalization Process Theory (2009) · cites this paper as [7]
In the citing paper
“By the end of 2006, the NPM in its published form [7] was sufficient as a set of conceptual tools to analyse specific processes, and it has been successfully applied to this purpose [32-36].”
From Development of a theory of implementation and integration: Normalization Process Theory (2009) · cites this paper as [7]
In the citing paper
“1. A complex intervention is disposed to normalization if it confers an interactional advantage in flexibly accomplishing congruence and disposal;”
From Development of a theory of implementation and integration: Normalization Process Theory (2009) · cites this paper as [7]
In the citing paper
“4. A complex intervention is disposed to normalization if it confers an advantage on an organization in flexibly executing and realizing work.”
From Development of a theory of implementation and integration: Normalization Process Theory (2009) · cites this paper as [7]
In the citing paper
“2. A complex intervention is disposed to normalization if it equals or improves accountability and confidence within networks;”
From Development of a theory of implementation and integration: Normalization Process Theory (2009) · cites this paper as [7]
In the citing paper
“The development of a set of explanatory ideas around normalization has shifted from an initial set of empirical generalizations presented as synthetic propositions or assertions [17], to a robust conceptual model that presented generalizable propositions [7], and finally to a middle-range theory that offers a set of mechanism-based explanations for processes of implementation, embedding, and integ”
From Development of a theory of implementation and integration: Normalization Process Theory (2009) · cites this paper as [7]
In the citing paper
“3. A complex intervention is disposed to normalization if it is calibrated to an agreed skill-set at a recognizable location in the division of labour;”
From Development of a theory of implementation and integration: Normalization Process Theory (2009) · cites this paper as [7]
In the citing paper
“The theory recognises the complex nature of healthcare work and the human relationships on which that work depends, but it lacks a theoretical perspective on the technology itself and remains explicitly couched in assumptions of 'rationality' rather than in normative concerns about what constitutes good clinical practice.52”
In the citing paper
“The precursor to NPT, normalization process model (NPM), originated from a large body of work on eHealth and was developed to explain the observation that many eHealth initiatives failed to embed into routine practice [112,113].”
From Web-Based Interventions for Behavior Change and Self-Management: Potential, Pitfalls, and Progress (2012) · cites this paper as [113]
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Mwanga, J. R., Hokororo, A., Ndosi, H., Masenge, T. J., Kalabamu, F. S., Tawfik, D. S., Mediratta, R. P., Rozenfeld, B., Berg, M., Smith, Z. H., et al. (2024) · BMC Health Services Research · doi:10.1186/s12913-024-11554-3 · Cited by 5
Rahayu, U., Ibrahim, K., & Herman, H. (2025) · Journal of Multidisciplinary Healthcare · doi:10.2147/jmdh.s523495 · Cited by 5
Hoffrén‐Mikkola, M., Eloranta, S., Teeri, S., Mikkola, T., & Komulainen, M. (2024) · International Journal of Older People Nursing · doi:10.1111/opn.12604 · Cited by 5
Bø, K.-E., Halvorsen, K. H., Le, A. Y.-N., & Lehnbom, E. C. (2024) · BMC Health Services Research · doi:10.1186/s12913-024-11014-y · Cited by 5
Gavin, J. P., Clarkson, P., Muckelt, P. E., Eckford, R., Sadler, E., McDonough, S., & Barker, M. E. (2024) · PLoS ONE · doi:10.1371/journal.pone.0307493 · Cited by 5
Leitch, S. V., Smith, A. J., Crengle, S. M., & Stokes, T. (2021) · Implementation Science Communications · doi:10.1186/s43058-021-00120-1 · Cited by 5
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HB-HTA as an implementation problem in Polish health policy
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MacFarlane, A. E., & Brún, M. O.-D. (2009) · University of Limerick Institutional Repository (University of Limerick) · doi:10.34961/7287 · Cited by 5
May, C. R., Albers, B., Bracher, M., Finch, T. L., Gilbert, A. W., Girling, M., Greenwood, K., MacFarlane, A. E., Mair, F. S., May, C., et al. (2021) · Research Square · doi:10.21203/rs.3.rs-870733/v1 · Cited by 5
Self-citationDelivering remote pulmonary rehabilitation in Bangladesh: a mixed-method feasibility study
Habib, G. M., Uzzaman, N., Rabinovich, R., Akhter, S., Sultana, M., Ali, M., & Pinnock, H. (2025) · Journal of Global Health · doi:10.7189/jogh.15.04002 · Cited by 5
Providing Outpatient Oncology Mental Health Support: Understanding Staff Perspectives
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Kumar, M. B., Mulongo, C. M., Pincerato, L., Vita, M. V. D., Saidi, S., Gakii, Y., Morino, G., & Kumar, P. A. (2024) · Oxford Open Digital Health · doi:10.1093/oodh/oqae037 · Cited by 5
Metadata
- Authors
- May, C.
- Affiliations
- Newcastle University (GB)
- Corresponding author
- May, Carl
- ORCID
- May, Carl
- Venue
- BMC Health Services Research
- Published
- 2006-12
- Volume
- 6
- Issue
- 1
- Pages
- 86-86
- ISSN
- 1472-6963 (ISSN-L)
- OpenAlex
- W1487109350
- Cited by
- 447
- References
- 90
- Citations by year
- 2026: 10 · 2025: 22 · 2024: 21 · 2023: 17 · 2022: 29 · 2021: 40 · 2020: 27 · 2019: 13 · 2018: 18 · 2017: 28 · 2016: 23 · 2015: 25 · 2014: 31 · 2013: 21 · 2012: 21
- FWCI
- 32.02
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Health Services Research (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed (publishedVersion)
- ePrints Soton (University of Southampton) (acceptedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Newcastle University ePrints (Newcastle Univesity)
- Funders
- University of Toronto
- Economic and Social Research Council (RES-000-27-0084)
- 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
- Social Sciences › Business, Management and Accounting › Management Information Systems › Information Systems Theories and Implementation
- Keywords
- complex interventions, telemedicine, professional-patient relationship, evidence-based practice, relational integration, contextual integration
- MeSH terms
- Chronic Disease, Depression, Diffusion of Innovation, United Kingdom, Humans, Outcome and Process Assessment, Health Care, Sociology, Medical, Systems Analysis, Technology Assessment, Biomedical, Reproducibility of Results, Low Back Pain, Models, Organizational, Telemedicine, Evidence-Based Medicine, Qualitative Research
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