Whole Systems Research Methods in Health Care: A Scoping Review

Abstract

Objectives: This scoping review evaluates two decades of methodological advances made by “whole systems research” (WSR) pioneers in the fields of traditional, complementary, and integrative medicine (TCIM). Rooted in critiques of the classical randomized controlled trial (RCT)'s suitability for evaluating holistic, complex TCIM interventions, WSR centralizes the principle of “model validity,” representing a “fit” between research design and therapeutic paradigm. Design: In consultation with field experts, 41 clinical research exemplars were selected for review from across 13 TCIM disciplines, with the aim of mapping the range and methodological characteristics of WSR studies. Using an analytic charting approach, these studies' primary and secondary features are characterized with reference to three focal areas: research method, intervention design, and outcome assessment. Results: The reviewed WSR exemplars investigate a wide range of multimodal and multicomponent TCIM interventions, typified by wellness-geared, multitarget, and multimorbid therapeutic aims. Most studies include a behavioral focus, at times in multidisciplinary or team-based contexts. Treatments are variously individualized, often with reference to “dual” (biomedical and paradigm-specific) diagnoses. Prospective and retrospective study designs substantially reflect established biomedical research methods. Pragmatic, randomized, open label comparative effectiveness designs with “usual care” comparators are most widely used, at times with factorial treatment arms. Only two studies adopt a double-blind, placebo-controlled RCT format. Some cohort-based controlled trials engage nonrandomized allocation strategies (e.g., matched controls, preference-based assignment, and minimization); other key designs include single-cohort pre–post studies, modified n-of-1 series, case series, case report, and ethnography. Mixed methods designs (i.e., qualitative research and economic evaluations) are evident in about one-third of exemplars. Primary and secondary outcomes are predominantly assessed, at multiple intervals, through patient-reported measures for symptom severity, quality of life/wellness, and/or treatment satisfaction; some studies concurrently evaluate objective outcomes. Conclusions: Aligned with trends emphasizing “fit-for-purpose” research designs to study the “real-world” effectiveness of complex, personalized clinical interventions, WSR has emerged as a maturing scholarly discipline. The field is distinguished by its patient-centered salutogenic focus and engagement with nonbiomedical diagnostic and treatment frameworks. The rigorous pursuit of model validity may be further advanced by emphasizing complex analytic models, paradigm-specific outcome assessment, inter-rater reliability, and ethnographically informed designs. Policy makers and funders seeking to support best practices in TCIM research may refer to this review ...

Research-related attitudes among Chinese medicine students at a Canadian college: a mixed-methods study

“…The issue of model validity, representing an appropriate “‘fit’ between a study’s design and the conceptual and clinical features of the studied intervention’s underlying or originating paradigm,” has been discussed at length in the traditional and complementary medicine literature, 10 including with specific reference to acupuncture and East Asian medicine 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21. The importance of ‘whole systems’ or ‘whole practice’-based clinical research, which moves beyond studying isolated modalities using placebo controls to instead evaluate the real-world effectiveness of complex, individualized interventions, continues to be centralized by the Society for Acupuncture Research, and appears to be receiving renewed attention from the National Center for Complementary and Integrative Health in the United States 22 As Wayne and colleagues note, 2 research coursework at institutions training practitioners of traditional and complementary medicine has the potential to make significant contributions to CAM [complementary and alternative medicine] research, especially toward ensuring that clinical research adequately reflects clinical practice.…”

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“…This content included an outline of the history and methodology of scientific research as it has been applied to the field of Chinese medicine. Topics covered included the purpose and weaknesses of the placebo-controlled trial methodology, [27][28][29] the development of pragmatic clinical trial models, 29 comparative effectiveness methodology, whole systems research, 30 mixed methods, and the use of outcome measures beyond those focused on the condition under investigation, such as quality-of-life measures. A similar approach was used to develop a research course for students at a Canadian Chinese medicine college.…”

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“…While the older NCCAM terminology focused more on whole medical systems as unique wholes, the newer NCCIH terminology has focused on how T&CM practices from whole medical systems can be successfully incorporated into traditional Western medicine to improve outcomes in health care using evidenced-based assessment methods (Ijaz et al, 2019). Likewise, the focus of NCCIH is moving away from the complete utilization of a whole medical system apart from Western medicine to researching which aspects of these whole medical systems have clinically based evidence for their use and incorporation into Western medical treatments.…”

“…Ritenbaugh et al defined a whole system of healing as "an approach in which practitioners apply bodies of knowledge and associated practices in order to maximize the patient's capacity to achieve mental and physical balance and restore their own health, using individualized, non-reductionist approaches to diagnosis and treatment" (Ritenbaugh et al, 2003, p. 32). Using this foundation, T&CM interventions focus on helping patients to learn individualized new behaviors and fostering experiences and lifestyle approaches that promote disease prevention as well as healing (Ijaz et al, 2019). Review and assessment of whole medical systems include integrating a "whole person assessment of a patient's physical, mental, emotional, and psychosocial wellbeing," with a focus on patient preferences, priorities, and values in their treatment design (Ijaz et al, 2019, p. S22).…”