Do participant treatment preferences shape shoulder pain trial outcomes?

In 2004, Thomas, et. al., conducted clinical trials, understanding the nuances of participant treatment preferences is pivotal, as they can significantly shape the outcomes observed. In a recent study focusing on shoulder pain management, researchers delved into how initial treatment preferences among participants influenced functional outcomes and subsequent treatment preferences.

Led by Elaine Thomas and her colleagues, the study was nested within a larger multicenter randomized controlled trial (RCT) comparing steroid injections to physiotherapy for unilateral shoulder pain. Conducted across nine general practices in north Staffordshire, the study enrolled 207 adults.

Participants’ treatment preferences and disability scores were assessed at two critical junctures: prior to randomization and at a 6-month follow-up post-randomization. A positive functional outcome was defined as a reduction of at least half in the disability score at the 6-month mark.

Initial findings revealed diverse pre-randomization preferences: 40% favored injection, 20% preferred physiotherapy, while 40% expressed no clear preference. Strikingly, participants who had expressed a treatment preference prior to randomization were more likely to achieve a favorable outcome compared to those who had not (62% vs. 48%).

However, the preference for the received treatment did not seem to confer additional benefit among those who had expressed a preference. Interestingly, at the 6-month mark, participants who experienced a positive outcome were more inclined to endorse the treatment they were randomized to, regardless of their initial preference or whether they actually received their preferred treatment.

This nuanced analysis underscores the intricate interplay between treatment preferences and outcomes in clinical trials. While pre-treatment preferences may indeed influence outcomes, the study highlights that actual treatment outcomes exert a stronger influence on subsequent treatment preferences. These findings provide empirical support for the assertion that participant treatment preferences can significantly impact the results of RCTs, shedding light on the complexity of patient involvement in medical research.

Reference: Thomas, E., Croft, P. R., Paterson, S. M., Dziedzic, K., & Hay, E. M. (2004). What influences participants’ treatment preference and can it influence outcome? Results from a primary care-based randomised trial for shoulder pain. British Journal of General Practice54(499), 93-96.

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