A Successful Strategy for Recruiting Elderly Patients with Mild Hyperparathyroidism into a Randomized Controlled Trial

Abstract

ABSTRACT Objective Effective strategies that improve the inclusion of older persons in clinical trials are needed to better characterize and treat chronic conditions that affect elderly patients. Especially challenging is the recruitment of the elderly into treatment trials for chronic conditions with vague symptoms, as is the case for primary hyperparathyroidism. The incidence of primary hyperparathyroidism increases with age, and the disease may present with symptoms that are difficult to objectively measure but contribute to decline of function and quality of life. Understanding the optimal treatment of primary hyperparathyroidism necessitates inclusion of greater numbers of older persons in treatment trials. As a part of our study of asymptomatic hyperparathyroidism, we also devised a strategy to recruit and retain older persons in a randomized surgical trial for primary hyperparathyroidism. Design Individuals greater than 60 years of age who did not meet established criteria for surgical intervention for primary hyperparathyroidism were offered the opportunity to participate in a clinical study evaluating the benefits of immediate minimally invasive parathyroidectomy (MIP) vs medical observation. Intervention Strategies to encourage participation and compliance included compensation for incidental expenses of lodging, meals, and travel for clinic visits related to the study as well as regular interaction with an experienced study coordinator. Measurements Study participation included formal neurocognitive evaluations, functional magnetic resonance brain imaging, functional performance batteries, and sleep studies over a 6-month period. Results Thirty-five individuals ranging in age from 61 to 79 years were screened for participation. Nine individuals were ineligible, and 14 of eligible individuals consented to participate in the study. Among the 12 eligible individuals who declined to participate, the most common reason identified was distance to study center. Conclusion We report an effective strategy to recruit a substantial proportion of eligible elderly individuals as subjects in a study of treatment strategies for a medical condition with few overt symptoms.