Article type
Abstract
Background: High-quality evidence is required to make informed decisions and develop tailored healthcare services. Commonly, these actions are based on findings from randomized controlled trials (RCTs), but ethical issues, costs, timing, or complexity can require different research approaches. According to Cochrane Rehabilitation’s definition for research purposes, rehabilitation is inherently complex. Experiences developed in this context, with the need to investigate complexity, eventually with study designs different from RCTs, could be usefully translated into other fields.
Objectives: To review the Medical Research Council-National Institute of Health Research’s latest framework (MRC-NIHR) for developing and evaluating complex interventions from the rehabilitation perspective.
Methods: Drawing from existing literature, frameworks, and discussions with experts, we proposed new research approaches to complex interventions in rehabilitation. The identified domains are accompanied by methodological considerations highlighting strengths and weaknesses. Furthermore, future perspectives and clinical implications are discussed along with examples of application from the rehabilitation field.
Results: We reviewed the 2021 version of the MRC-NIHR framework developed to identify key questions about complex interventions and to design and conduct research with diverse perspectives and appropriate choice of methods. It identified 4 interrelated and overlapping phases: 1) development or identification of the intervention, 2) feasibility, 3) evaluation, and 4) implementation, with different methods and tools to address each phase. Illustrative examples of application in rehabilitation plus main strengths and limitations are provided for each study design, demonstrating the potential benefits of the MRC-NIHR framework in developing evidence when RCTs are not applicable (Table 1).
Conclusions: The application of the MRC-NIHR framework approach is important to provide new robust evidence about complex interventions, including rehabilitation, because there are circumstances where RCTs are not applicable, feasible, or adequate for estimating real clinical impact. We aimed to strengthen methodological approaches used to estimate effects when RCTs cannot be conducted to facilitate more robust evidence production, in rehabilitation but also in other fields with similar shortcomings.
Relevance and importance to patients: The application of new research approaches in fields where RCTs are not always the optimal study design could promote the production of more informative, trustworthy evidence for patients.
Objectives: To review the Medical Research Council-National Institute of Health Research’s latest framework (MRC-NIHR) for developing and evaluating complex interventions from the rehabilitation perspective.
Methods: Drawing from existing literature, frameworks, and discussions with experts, we proposed new research approaches to complex interventions in rehabilitation. The identified domains are accompanied by methodological considerations highlighting strengths and weaknesses. Furthermore, future perspectives and clinical implications are discussed along with examples of application from the rehabilitation field.
Results: We reviewed the 2021 version of the MRC-NIHR framework developed to identify key questions about complex interventions and to design and conduct research with diverse perspectives and appropriate choice of methods. It identified 4 interrelated and overlapping phases: 1) development or identification of the intervention, 2) feasibility, 3) evaluation, and 4) implementation, with different methods and tools to address each phase. Illustrative examples of application in rehabilitation plus main strengths and limitations are provided for each study design, demonstrating the potential benefits of the MRC-NIHR framework in developing evidence when RCTs are not applicable (Table 1).
Conclusions: The application of the MRC-NIHR framework approach is important to provide new robust evidence about complex interventions, including rehabilitation, because there are circumstances where RCTs are not applicable, feasible, or adequate for estimating real clinical impact. We aimed to strengthen methodological approaches used to estimate effects when RCTs cannot be conducted to facilitate more robust evidence production, in rehabilitation but also in other fields with similar shortcomings.
Relevance and importance to patients: The application of new research approaches in fields where RCTs are not always the optimal study design could promote the production of more informative, trustworthy evidence for patients.