222534 Challenges in recruiting for a Randomized Controlled Trial at a Complementary and Alternative Medicine Institution

Monday, November 8, 2010

Sivarama Prasad Vinjamury, MD , College of Acupuncture and Oriental Medicine, Southern California University of Health Sciences, Whittier, CA
Bei-Bei (Julia) Wu, MAOM , Southern California University of Health Sciences, Whittier, CA
Randomized Controlled Trials (RCT) are considered as Gold standard in clinical trials because they typically generate evidence of the highest grade. Complementary and Alternative Medicine (CAM) treatments are often required to go through rigorous testing using this model to validate their therapeutic benefits. However, there are many challenges in conducting a RCT in CAM. Double blinding and standardization of CAM specific diagnostic procedures and the selection of treatment and dosage (which are supposed to be individualized) are some of the challenges the researchers struggle with during RCT designing and execution stages. We believe that recruitment is an additional hurdle to be crossed by the investigators if it is conducted at a CAM institution. Unlike conventional medical institutions and secondary or tertiary care centers, the infrastructure, patient flow and funding are scarce at most CAM institutions. Given the limited resources in terms of patients, the investigators are required to depend upon community wide recruitment for specialized conditions such as Fibromyalgia. In this paper, we would like to share our experience of how we overcame the hurdles in recruitment for a RCT that tested the efficacy of acupuncture for treating fibromyalgia. During this trial, we found that registering the trial at clinicaltrials.gov and presenting the trial at fibromyalgia support groups were the two most successful methods of recruitment for this trial. The paper would also discuss the participant referral patterns in addition to successful and unsuccessful recruitment methods used in this clinical trial.

Learning Areas:
Conduct evaluation related to programs, research, and other areas of practice
Public health or related research

Learning Objectives:
Identify the challenges in recruitment for Randomized controlled trials Describe the methods adopted to overcome the challenges in recruitment for a RCT at a CAM institution

Keywords: Challenges and Opportunities, Research

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: Writing this paper and presenting it. I am the PI of this study
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.