3167.0: Monday, October 22, 2001 - 5:15 PM

Abstract #30994

Lessons Learned: Recruiting and Enrollment in CAM Trials

Suzanna M. Zick, ND, MPH, Elena Gillespie, Keith Aaronson, MD, MS, and Martin Stevens, MD. U of M CAM Research Center, University of Michigan CAM Research Center, 715 E. Huron Street, Suite 1 West, Ann Arbor, MI 48104, 734-998-7715, szick@umich.edu

. Methods: Analysis of the number of patients screened and recruited in two contrasting alternative medicine trials. Additionally, analysis of why patients chose not to participate in CAM trials. Results: In a trial examining the use of an herbal product for individuals with congestive heart failure (CHF) roughly 88 % of known eligible patients decided to participate in the trial and only 5 % of all patients screened gave lack of interest in the trial as a reason for non-participation. In contrast, two recent trials (SOLVD & MERIT-HF) of patients with symptomatic CHF had lower rates of known eligible patients agreeing to participate (63 %) and at least 11 % of all patients screened gave lack of interest in the trial as a reason for non-participation. More dramatically, in a study assessing the effectiveness of a bioenergy technique in the management of chronic pain approximately 96 % of known eligible patients decided to participate in the trial compared to only 10 % of known eligible patients from similar populations approached for trials at the same tertiary care facility. In the bioenergy trial 33 % of patients screened refused participation due to the distance and travel time involved, making it the primary reason for refusal. The frequency and length of visits involved in the application of a manual technique was the next most frequently stated reason for non-participation (31%). A small percent of patients (< 2%) refused on the basis of their religious beliefs.

Learning Objectives: To compare and contrast the unique aspects of recruiting and enrollment of patients in CAM trials compared to allopathic trials.

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
Disclosure not received
Relationship: Not Received.

Handout (.ppt format, 184.5 kb)

The 129th Annual Meeting of APHA