Developing and employing a 'responsive manualization' in the 'Acupuncture Approaches to Decrease Disparities in Outcomes of Pain Treatment' comparative effectiveness study

Objective: The aim of this article is to describe the process used to develop an acupuncture therapy manual for a large effectiveness trial comparing individual care against group care for chronic pain in an underserved population. The design needed to not only ensure research consistency and replicability but also be 'responsive' to real world heterogeneous and evolving presentations in challenging physical settings. Background: Chronic pain is prevalent in the United States. While acupuncture is effective for chronic pain, minority, ethnically diverse and lower socioeconomic populations have limited access. Group acupuncture is proposed as a lower cost option to facilitate access in safety net settings, but research on the effectiveness of group versus individual acupuncture is lacking. Methods: We engaged a modified Delphi process with expert practitioners from diverse backgrounds who were experienced in individual and group practice. All contributions were recorded and collated for second- and third-round consensus discussions that included contributions by the trial's research acupuncturists. Results: A 'responsive manual' flow chart was created with suggested sequencing that included interviews concurrent with palpation, Tui na, Gua sha, acupuncture needling, ear treatment, basic recommendations and options for departure with rationale. The manual was implemented by six research acupuncturists in five primary care settings in the Bronx, New York, with weekly team meetings to discuss manual use. There were no serious adverse events (AE) and few minor AE reported in this trial. Conclusion: A 'responsive manual' can be structured and implemented that is not only consistent and replicable but also flexible to accommodate the real-world clinical needs of practitioners and patients in challenging physical settings.