Whole Systems Research Methods in Health Care: A Scoping Review.

Area of Science:

• Methodological advances in Traditional, Complementary, and Integrative Medicine (TCIM) research.

Background:

• Classical randomized controlled trials (RCTs) face limitations in evaluating complex, holistic TCIM interventions.
• Whole Systems Research (WSR) addresses these limitations by centering "model validity," ensuring research design aligns with therapeutic paradigms.

Purpose of the Study:

• To conduct a scoping review of methodological advancements in WSR over two decades.
• To map the range and characteristics of WSR studies across 13 TCIM disciplines.

Main Methods:

• Reviewed 41 clinical research exemplars of WSR.
• Utilized an analytic charting approach to characterize studies based on research method, intervention design, and outcome assessment.

Main Results:

• WSR studies examine diverse multimodal TCIM interventions with wellness, multitarget, and multimorbid aims, often including behavioral and individualized components.
• Pragmatic, comparative effectiveness designs and single-cohort pre-post studies are common; few RCTs use double-blind, placebo-controlled formats.
• Patient-reported outcomes (symptom severity, quality of life, satisfaction) are primary, often supplemented by objective measures and mixed methods.

Conclusions:

• WSR is a maturing discipline focused on "fit-for-purpose" research for real-world effectiveness of complex, personalized TCIM.
• The field emphasizes patient-centered, salutogenic approaches and nonbiomedical frameworks.
• Advancements may include complex analytic models, paradigm-specific outcomes, and ethnographically informed designs for policy makers and funders.