Abstract
Background: Pragmatic trials inform clinical decision with better generalizability and can bridge different streams of medicine. This study collated the expectations regarding pragmatic trial design of integrative medicine (IM) for diabetes and kidney diseases among patients and physicians. Dissonance between users' perspective and existing pragmatic trial design was identified. The association between risk of bias and pragmatism of study design was assessed.Method: A 10-group semi-structured focus group interview series [21 patients, 14 conventional medicine (ConM) and 15 Chinese medicine (CM) physicians] were purposively sampled from private and public clinics in Hong Kong. Perspectives were qualitatively analyzed by constant comparative method. A systematic search of four databases was performed to identify existing IM pragmatic clinical trials in diabetes or kidney disease. Primary outcomes were the pragmatism, risk of bias, and rationale of the study design. Risk of bias and pragmatism were assessed based on Cochrane risk-of-bias tool and PRECIS-2, respectively. The correlation between risk of bias and pragmatism was assessed by regression models with sensitivity analyses.Results: The subtheme on the motivation to seek IM service was analyzed, covering the perceived limitation of ConM effect, perceived benefits of IM service, and assessment of IM effectiveness. Patients expected IM service to retard disease progression, stabilize concomitant drug dosage, and reduce potential side effects associated with ConM. In the systematic review, 25 studies from six countries were included covering CM, Korean medicine, Ayurvedic medicine, and western herbal medicine. Existing study designs did not include a detailed assessment of concomitant drug change and adverse events. Majority of studies either recruited a non-representative proportion of patients as traditional, complementary, and integrative medicine (TCIM) diagnosis was used as inclusion criteria, or not reflecting the real-world practice of TCIM by completely dropping TCIM diagnosis in the trial design. Consultation follow-up frequency is the least pragmatic domain. Increase in pragmatism did not associate with a higher risk of bias.Conclusion: Existing IM pragmatic trial design does not match the patients' expectation in the analysis of incident concomitant drug change and adverse events. A two-layer design incorporating TCIM diagnosis as a stratification factor maximizes the generalizability of evidence and real-world translation of both ConM and TCIM.
Highlights
Pragmatic trials evaluate the effectiveness of interventions in the real-world setting aiming to inform clinical decision and implementation with better generalizability [1, 2]
Majority of patients had poor glycemic control (71.4%), with stage 2–4 chronic kidney disease (CKD) (95.2%) and albuminuria (90.5%); 4.8% of patients reached end-stage kidney failure, 57.1% (n = 8/14) of conventional medicine (ConM) physicians specialized in internal medicine, 42.9% (n = 6/14) of ConM physicians specialized in family medicine or practiced as general practitioners, 42.9% (n = 6/14) of ConM physicians received Chinese medicine (CM) education, and all (n = 15) CM physicians received substantial credit bearing ConM education from their undergraduate study
To facilitate the implementation of evidence to integrative medicine (IM) service, we propose not to include TCIM-specific diagnosis in the inclusion/exclusion criteria of IM pragmatic trials to maximize the representation of the study population of interest [49]
Summary
Pragmatic trials evaluate the effectiveness of interventions in the real-world setting aiming to inform clinical decision and implementation with better generalizability [1, 2]. There are continuous concerns on the conventional evidence-based paradigm building on meta-analyses and randomized controlled trials with limited personalized design (e.g., prespecified subgroup analysis, responder analysis), such as being over-concentrated in population-based assessment [14, 15], over-standardized treatment [15, 16], and lacking personalization [17]. This affected the clinical utility of the evidence [18] and was contradicted with many core principles of TCIM. The association between risk of bias and pragmatism of study design was assessed
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