Article type
Abstract
"Background: There is an increasing need for rehabilitation research. Rehabilitation interventions are distinct from other healthcare interventions (i.e., pharmaceuticals), because they are complex and multimodal, tailored to patients’ needs and involve diverse practitioners. It is therefore difficult to develop rehabilitation interventions and rigorously test them in research. To date, we lack a framework to guide their development.
Objectives: To develop a structured framework to guide the development, study and implementation of interventions for rehabilitation. A framework for rehabilitation research that builds on sequential steps will allow researchers to develop theoretically and clinically sound interventions and test them in a methodologically rigorous manner. Using the framework may improve rehabilitation research outcomes and prevent research waste.
Methods: We propose adapting the Idea, Development, Exploration, Assessment and Long-term follow-up (IDEAL) for surgical procedures and IDEAL-Physio Frameworks to the discipline-inclusive IDEAL-Rehab Framework to help address unique challenges and opportunities provided by rehabilitation interventions. The Framework has distinct stages: 1) Pre-clinical - defining the procedure and considering feasibility, risks and safety; 2) Idea (I) - proof of concept studies, case reports; 3) Development (D) - with iterative procedural changes, case studies; 4) Exploration (E) - comparative evaluation pilot/feasibility studies; 5) Assessment (A) - comparative effectiveness testing using RCTs, observational designs, target trial emulation; and 6) Long-term Study (L) - adverse event surveillance, registries/databases. The proposed adaptation of the IDEAL Framework was conceptualized by a core team of multi-professional rehabilitation providers and scientists. A larger expert panel, attending the 5th Cochrane Rehabilitation Methodology Meeting in 2023, provided feedback via manuscript review, post-oral presentation, and group discussion. The IDEAL Framework, revised according to rehabilitation implementation and practice expertise, and supplemented with concepts from the UK Medical Research Council (MRC) Framework for complex interventions, informed the current iteration of the IDEAL-Rehab Framework (Figure 1).
Conclusions:
Relevance for patients: The IDEAL-Rehab Framework promotes a structured and transparent approach to develop interventions for rehabilitation by testing clinical utility in a progression of study designs. This work is the precursor and impetus to a modified-Delphi study with the objective of developing a final, trans-disciplinary and internationally informed comprehensive IDEAL-Rehab Framework.
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Objectives: To develop a structured framework to guide the development, study and implementation of interventions for rehabilitation. A framework for rehabilitation research that builds on sequential steps will allow researchers to develop theoretically and clinically sound interventions and test them in a methodologically rigorous manner. Using the framework may improve rehabilitation research outcomes and prevent research waste.
Methods: We propose adapting the Idea, Development, Exploration, Assessment and Long-term follow-up (IDEAL) for surgical procedures and IDEAL-Physio Frameworks to the discipline-inclusive IDEAL-Rehab Framework to help address unique challenges and opportunities provided by rehabilitation interventions. The Framework has distinct stages: 1) Pre-clinical - defining the procedure and considering feasibility, risks and safety; 2) Idea (I) - proof of concept studies, case reports; 3) Development (D) - with iterative procedural changes, case studies; 4) Exploration (E) - comparative evaluation pilot/feasibility studies; 5) Assessment (A) - comparative effectiveness testing using RCTs, observational designs, target trial emulation; and 6) Long-term Study (L) - adverse event surveillance, registries/databases. The proposed adaptation of the IDEAL Framework was conceptualized by a core team of multi-professional rehabilitation providers and scientists. A larger expert panel, attending the 5th Cochrane Rehabilitation Methodology Meeting in 2023, provided feedback via manuscript review, post-oral presentation, and group discussion. The IDEAL Framework, revised according to rehabilitation implementation and practice expertise, and supplemented with concepts from the UK Medical Research Council (MRC) Framework for complex interventions, informed the current iteration of the IDEAL-Rehab Framework (Figure 1).
Conclusions:
Relevance for patients: The IDEAL-Rehab Framework promotes a structured and transparent approach to develop interventions for rehabilitation by testing clinical utility in a progression of study designs. This work is the precursor and impetus to a modified-Delphi study with the objective of developing a final, trans-disciplinary and internationally informed comprehensive IDEAL-Rehab Framework.
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