Beyond Efficacy and Effectiveness: Conducting Economic Analyses During Clinical Trials

Few studies have examined cost issues in the field of dysphagia. This study presents cost data collected during a clinical trial in speech–language pathology, demonstrating the types of cost analyses that can be conducted and highlighting obstacles and issues facing investigators who seek to conduct economic analyses in this arena. Seventy-nine patients were enrolled in the clinical trial to assess the impact of a swallowing intervention on swallowing and speech function. The patients were at least one year past treatment for head and neck cancer. No significant intervention differences were detected in these outcomes. A companion economic analysis was conducted in 37 of these patients using patient diaries and followup with identified health care providers. Analyses indicated that (1) the intervention did not significantly reduce health care expenditures; (2) indirect costs and costs of hospitalizations are both important factors to consider during a trial; and (3) health care costs of this population are high relative to the rest of the U.S. population. Attrition from the overall study population can pose a serious threat to the viability of an economic study. The article concludes with a discussion of how these issues can be addressed in future studies.This research was supported by NIH/NCI P01 CA40007 and NIDCD U01 DC03206.