NPI Model: Standardised Framework for Evaluating Non-Pharmacological Interventions in the French Health Context Authors
authors
keywords
- Non-pharmacological interventions
- Complex interventions
- Health
- Prevention
- Care
- Framework
- Epistemology
- Methodology
- Ethics
document type
OTHERabstract
Background The term non-pharmacological interventions (NPIs) refers to health prevention and care protocols predominantly with a physical, nutritional or psychosocial focus supervised by a healthcare professional. Unlike drugs and medical devices, no consensual model for evaluating these complex interventions existed prior to the present study because of the heterogeneity in intervention content and study protocols. This heterogeneity limited the transferability of good practices and led to a great deal of mistrust in NPIs among professionals and healthcare users alike. The present study involved the co-construction of a consensual framework for the evaluation of NPIs, which meets both the specificity of these types of interventions and international standards for research in the field of health. Method The study involved all concerned stakeholders in France, including academic and non-academic, researchers, healthcare users, health practitioners, health operators, scientific societies and health authorities. The framework was co-constructed under the direction of a multidisciplinary committee of 22 experts through iterative, open and tracked exchanges, in four successive stages: work performed by a select committee, work performed by a larger committee, open vote by college, and finally, consultation with health authorities and scientific societies. Results The framework for evaluating NPIs, called the ‘NPI Model’, includes 14 ethical invariants and 63 methodological invariants distributed between five types of study: mechanistic, observational, prototypical, intervention, and implementation. It received the support of 28 scientific societies and three French health authorities. Conclusion The creation of a standardized framework for evaluating NPIs in the French context has several advantages, as follows: i) it harmonises and clarifies epistemological, methodological and ethical expectations of NPI evaluation studies for researchers; ii) it ensures greater transferability of study results to real-world clinical use of the relevant NPI; iii) it guarantees that programs for professionals in the healthcare, prevention and social assistance sectors are more operational; iv) it facilitates efficient and safer practices for healthcare users; v) it helps to provide decision-makers and regulators with a greater understanding of NPIs; vi) it ensures more traceable interventions for health operators; vii) it provides solutions that can be better integrated into the financing strategies of insurance and social solidarity systems.
