Objectives: Disinvestment is critical for ensuring the long-term sustainability of health-care services. Key barriers to disinvestment are heterogeneity between research and clinical settings, absence of evidence of effectiveness of some health technologies, and exposure of patients and organizations to risks and poor outcomes. We aimed to develop a feasible research design that can evaluate disinvestment in health technologies of uncertain effectiveness or cost-effectiveness.
Study design and setting: This article (1) establishes the need for disinvestment methodologies, (2) identifies the ethical concerns and feasibility constraints of conventional research designs for this issue, (3) describes the planning, implementation, and analytical framework for a novel disinvestment-specific study design, and (4) describes potential limitations in application of this design.
Results: The stepped-wedge, roll-in cluster randomized controlled trial can facilitate the disinvestment process, whereas generating evidence to determine whether the decision to disinvest was sound in the clinical environment. A noninferiority research paradigm may be applied to this methodology to demonstrate that the removal of a health technology does not adversely affect outcomes.
Conclusion: This research design can be applied across multiple fields and will assist determination of whether specific health technologies are clinically effective, cost-effective, and safe.
Keywords: Comparative efficacy; Disinvestment; Health; Non-inferiority; Roll-in; Stepped wedge.
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