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Cost-Effectiveness Analysis to Inform Randomized Controlled Trial Design in Chronic Pain Research: Methods for
Haley Rafferty1, Elisa Rocha1, Paola Gonzalez-Mego1,2
1Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Charlestown, MA, USA.
Principles and Practice of Clinical Research (2015)
|December 23, 2022
Summary
Cost-effectiveness analysis (CEA) can objectively design randomized controlled trials (RCTs), determining if a run-in (RI) period is cost-effective for chronic pain (CP) RCTs. Results show RI periods are more cost-effective with lower patient adherence and higher treatment costs.
Area of Science:
- Clinical trial design
- Health economics
- Pain research
Background:
- Run-in (RI) periods in randomized controlled trials (RCTs) aim to improve validity but their use in chronic pain (CP) RCTs is debated.
- Cost-effectiveness analysis (CEA) is typically used for evaluating RCT outcomes, not for designing RCTs.
Purpose of the Study:
- To present a step-by-step method for objectively designing RCTs using CEA.
- To determine the cost-effectiveness of including a RI period in CP RCTs.
Main Methods:
- Applied CEA methodology to data from noninvasive brain stimulation CP RCTs.
- Focused on defining the CEA research question, identifying RCT phases and costs, discounting, modeling RCT stochasticity, and performing sensitivity analyses.
- Assessed average and incremental cost-effectiveness ratios for various RCT designs with and without RI periods.
Main Results:
- Demonstrated the impact of varying factors like institution numbers, patient capacity, cost/effectiveness discounts, component costs, and patient adherence on RI and no-run-in (NRI) designs.
- Showcased that lower patient adherence, lower baseline assessment costs, and higher treatment costs necessitate RI periods for cost-effectiveness in CP RCTs compared to NRI designs.
Conclusions:
- CEA methods enable clinical trialists to optimize CP RCT study designs.
- Informed decisions regarding the inclusion or exclusion of RI periods can be made using CEA.
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