Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources
Alana Steffen, Larisa Burke, Heather Pauls, Marie L. Suarez, Yingwei Yao, William H. Kobak, Miho Takayama, Hiroyoshi Yajima, Ted J. Kaptchuk, Nobuari Takakura, Diana J. Wilkie, Judith M. Schlaeger
Abstract
BACKGROUND: Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia. METHODS: Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding. RESULTS: At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments. DISCUSSION: Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.