Challenges in developing national orthopedic health research agendas in the Netherlands: process overview and recommendations.

Growing demand for clinical research to improve evidence-based medicine in daily medical practice led to healthcare evaluation, which assesses the effectiveness of the existing care. The first step is identifying and prioritizing the most important evidence uncertainties. A health research agenda (HRA) can be valuable and helps determine funding and resource allocation, aiding researchers and policymakers to design successful research programs and implement the results in daily medical practice. We provide an overview of the development process of the first 2 HRAs within orthopedic surgery in the Netherlands and the following research process. In addition, we developed a checklist with recommendations for the future development of an HRA. This perspective guides the development of highquality and widely supported nationwide HRAs, including preparatory actions. This improves the uptake of evidence uncertainties in a successful research program and disseminates evidence-based literature in daily medical practice to improve patient care.

Cost-Effectiveness of Urea Excipient-Based Drug-Coated Balloons for Chronic Limb-Threatening Ischemia from Femoropopliteal Disease in the Netherlands and Germany.

PURPOSE: Drug-coated balloons (DCBs) for femoropopliteal peripheral artery disease have been shown to be clinically superior and cost-effective compared to conventional percutaneous transluminal angioplasty (PTA). However, few studies enrolled patients with chronic limb-threatening ischemia (CLTI). Our objective was to study the cost-effectiveness of endovascular treatment with versus without DCB in CLTI patient populations in the Netherlands and Germany. MATERIAL AND METHODS: Target lesion revascularization (TLR) and major amputation rates were obtained from the CLTI subgroup of the IN.PACT Global study. Rates for "status quo" treatment involving PTA with primary or bailout stenting were derived from systematic literature search. Costs and cost-effectiveness were calculated using a decision-analytic Markov model considering, in the base case, a 2-year horizon, and strategy-specific quality-adjusted life year (QALY) gains calculated from survival and health state-specific utilities. A willingness-to-pay threshold of €50,000/QALY was assumed, and extensive sensitivity analyses were performed. RESULTS: Model-projected 24-month probabilities of TLR were 26.2% and 32.8% for treatment with and without DCB, and probabilities for amputation were 2.8% and 11.9%, respectively. DCB added 0.017 QALYs while saving €1,030 in the Dutch setting and €513 in the German setting, respectively. DCB was found dominant or cost-effective across a wide range of assumptions. CONCLUSION: Urea excipient drug-coated balloon therapy for treating CLTI from femoropopliteal artery disease is associated with improved patient outcomes and expected overall cost savings to payers in the Dutch and German healthcare systems, rendering it a cost-effective and likely dominant treatment strategy.