Abstract
OBJECTIVES: Claudication, a symptom commonly associated with peripheral artery disease, affects approximately 30-40% of adults in the United States. A decision analysis is needed to integrate data, information, and knowledge from multiple sources about the stages of a patient's journey in this condition to assess the optimal treatment approach. METHODS: We designed a decision model including patient perspective and outcomes of claudication, peripheral vascular intervention, open surgical bypass, chronic limb-threatening ischemia, and amputation. Time horizon was 2 years and tradeoffs were expressed as "cost-effectiveness," with "cost" taken as number of procedures, and "effectiveness," the amount of time in claudication and/or recovery. The treatment alternatives were peripheral vascular intervention within 6 months of initial diagnosis of claudication (early peripheral vascular intervention) or peripheral vascular intervention >6 months after claudication diagnosis (to allow for guideline-directed conservative therapy first). Probabilities were derived from 100% Medicare fee-for-service claims data between January 2017 and December 2021. A Markov model was designed and populated for the 2 scenarios. The main outcomes included the estimated number of peripheral vascular interventions, estimated number of open bypass procedures, and total time in claudication. Using Monte Carlo Simulation, 1,000,000 patients were run through the model for the 2-year time horizon. Sensitivity analysis using propensity score matching was conducted to control for baseline differences between groups, matching patients on age, sex, race, and comorbidities. RESULTS: A cohort comprising 445,305 patients newly diagnosed with claudication was identified, exhibiting a mean age of 76.2 years. Among these patients, 12,102 (2.7%) underwent early peripheral vascular intervention, whereas 433,203 (97.3%) had no early peripheral vascular intervention. The simulation demonstrated that patients who underwent an early peripheral vascular intervention experienced an estimated average of 3.6 peripheral vascular interventions over the 2 years, whereas those who did not undergo early peripheral vascular intervention averaged 0.3 PVIs over 2 years. Moreover, patients who underwent early peripheral vascular intervention were projected to undergo an average of 1.7 open bypass procedures subsequent to the initial diagnosis of claudication, whereas those who did not receive early peripheral vascular intervention were expected to undergo 0.8 open bypass procedures. The duration of time spent in a state of claudication was observed to be 190 days for patients who underwent early peripheral vascular intervention, in contrast to 360 days for those who did not receive early peripheral vascular intervention. After controlling for baseline characteristics such as age, sex, race, and comorbidities, the results remained consistent in the propensity score matched groups. CONCLUSION: Our novel methodology used claims data to arrive at day-to-day transitions to assess the impact of early peripheral vascular intervention in the management of claudication among patients. Our findings reinforce professional guidelines that early peripheral vascular intervention may not confer beneficial outcomes to patients, potentially leading to adverse effects and necessitating further interventions. This study underscores the significance of health care informatics in harnessing data, technology, and analytical methodologies to enhance decision-making processes, optimize resource allocation, improve the quality-of-care delivery, and promote evidence-based practices within the health care domain.