Background. Whole medicine and health systems like traditional and complementary medicine systems (T&CM) are part of healthcare around the world. One key feature of T&CM is its focus on patient-centered and multimodal care and the integration of intercultural perspectives in a wide range of settings. It may contribute to good health and well being for people as part of the Sustainable Development Goals of the United Nations. The authentic, rigorous, and fair evaluation of such a medical system, with its inherent complexity and individualization, imposes methodological challenges. Hence, we propose a broad research strategy to test and characterize its possible contribution to health. Methods. To develop a research strategy for a specific T&CM system, Anthroposophic Medicine (AM), applying multimodal integrative healthcare based on a four-level concept of man, we used a three-phase consensus process with experts and key stakeholders, consisting of (1) premeeting methodological literature and AM research review and interviews to supplement or revise items of the research strategy and tailor them to AM research, (2) face-toface consensus meetings further developing and tailoring the strategy, and (3) postmeeting feedback and review, followed by finalization. Results. Currently, AM covers many fields of medical specialties in varied levels of healthcare settings, such as outpatient and inpatient; primary, secondary, and tertiary care; and health education and pedagogy. It is by definition integrated with conventional medicine in the public healthcare system. It applies specific medicines, nursing techniques, arts therapies, eurythmy therapy, rhythmical massage, counseling, and psychotherapy, and it is provided by medical doctors, nurses, therapists, midwives, and nutritionists. A research strategy authentic to this level of complexity should comprise items with a focus on (I) efficacy and effectiveness, divided into (a) evaluation of the multimodal and multidisciplinary medical system as a whole, or of complex multimodal therapy concept, (b) a reasonable amount of methodologically rigorous, confirmatory randomized controlled trials on exemplary pharmacological and nonpharmacological therapies and indications, (c) a wide range of interventions and patient-centered care strategies with less extensive formats like well-conducted small trails, observational studies, and high quality case reports and series, or subgroup analyses from whole-system studies, or health service research; (II) safety; (III) economics; (IV) evidence synthesis; (V) methodologic issues; (VI) biomedical, physiological, pharmacological, pharmaceutical, psychological, anthropological, and nosological issues as well as innovation and development; (VI) patient perspective and involvement, public needs, and ethics; (VII) educational matters and professionalism; and (IX) disease prevention, health promotion, and public health.
Conclusion The research strategy extends to and complements the prevailing hierarchical system by introducing a broad “evidence house” approach to evaluation, something many health technology assessment boards today support. It may provide transparent and comprehensive insight into potential benefits or risks of AM. It can serve as a framework for an evidence-informed approach to AM for a variety of stakeholders and collaborating networks with the aim of improving global health.