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APHA Scientific Session and Event Listing

Recorded presentation

Adele Mattinat Spegman, PhD, RN, Mitchell Haas, DC, and Bonnie Ganger. Center for Outcomes Studies, Western States Chiropractic College, 2900 NE 132nd Avenue, Portland, OR 97214, 503.251.2809, aspegman@wschiro.edu

The current emphasis on quality healthcare is propelled, in part, by consumers' scrutiny of options and rising healthcare costs. This issue is especially important for health care disciplines that typically manage patients with multiple care visits. Our preliminary research suggested a dose-response relationship with chiropractic care for chronic headache.

The current study, for which data collection is nearing completion, has provided valuable lessons about the complex challenges of conducting open-label clinical trials as community-based research. The design must address various threats to internal validity: participants' perception of expectation, enthusiasm, and attention; providers' expectations, study fatigue, and intervention drift. Randomization can also be compromised by the difficulties of blinding both the participant and provider to treatment group assignments and masking the placebo treatments.

This presentation describes the approaches used to minimize threats to internal validity. Data are reported regarding the successful controlling of participants' expectations and perceptions of doctor's enthusiasm, and protocol adherence. We will also discuss the impact of provider training and an approach to double-blinded randomization. Insights from this discussion will be extended to the larger arena CAM research.

This research was supported by a grant from the National Center for Complementary and Alternative Medicine, National Institutes of Health (R21 AT002324).

Learning Objectives:

• List five threats to internal validity when clinical trials are conducted in community settings.
• Discuss three issues unique to double-blinded RTCs of a manipulative modality.
• Identify three purposes for conducting provider training throughout the data collection period.

Keywords: Chiropractic, Alternative Medicine/Therapies

Presenting author's disclosure statement:

Any relevant financial relationships? No

Recorded presentation