Understanding Patient Values and the Manifestations in Clinical Research with Traditional Chinese Medicine—With Practical Suggestions for Trial Design and Implementation

Objective. To define patient values, identify their manifestations in a randomized clinical trial, and investigate the possible implications for clinical research of traditional Chinese medicine.Methods. We categorized patient values manifestations into patient choice, preference, compliance, and patient-reported outcomes and summarized the underlying personal values through purposeful electronic searches for relevant reports. By hypothesizing a set of positive versus negative circumstances occurring in the enrollment, intervention allocation, treatment, and the follow-up stage of a trial, it is possible to discuss the potential implications of patient values manifestation on a trial with traditional Chinese medicine.Results. Patient values and its manifestations are ubiquitous in the process of clinical research with traditional Chinese medicine. These values may provide motivation for participation or engender the internal and external validity of the study.Conclusions. Trialists should attach sufficient importance to the needs and concerns of individual participant. To incorporate patient values into the design and conduct of a clinical study with traditional Chinese medicine, researchers are recommended to adopt participant-friendly design and use patient-reported outcomes, take convenience-for-patients measures, and help foster rational beliefs and behaviors of trial participants.

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Is Traditional Chinese Medicine Use Associated with Worse Patient-reported Outcomes among Chinese American Rheumatology Patients?

The Journal of Rheumatology ◽

10.3899/jrheum.181148 ◽

2019 ◽

Vol 46 (12) ◽

pp. 1634-1639 ◽

Cited By ~ 1

Author(s):

Kai Sun ◽

Jackie Szymonifka ◽

Henghe Tian ◽

Yaju Chang ◽

Jennifer C. Leng ◽

...

Keyword(s):

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Rheumatic Disease ◽

Patient Reported Outcomes ◽

Multivariable Analysis ◽

Chinese American ◽

Chinese Americans ◽

The United States ◽

Targeted Interventions ◽

Patient Reported

Objective.Chinese Americans are a fast-growing immigrant group with more severe rheumatic disease manifestations than whites and often a strong cultural preference for traditional Chinese medicine (TCM). We aimed to examine TCM use patterns and association with patient-reported outcomes (PRO) among Chinese American rheumatology patients.Methods.Chinese Americans actively treated for systemic rheumatic diseases were recruited from urban Chinatown rheumatology clinics. Data on sociodemographics, acculturation, clinical factors, and TCM use (11 modalities) were gathered. Self-reported health status was assessed using Patient Reported Outcomes Measurement Information System (PROMIS) short forms. TCM users and nonusers were compared. Factors independently associated with TCM use were identified using multivariable logistic regression.Results.Among 230 participants, median age was 57 years (range 20–97), 65% were women, 71% had ≤ high school education, 70% were on Medicaid insurance, 47% lived in the United States for ≥ 20 years, and 22% spoke English fluently. Half used TCM in the past year; these participants had worse self-reported anxiety, depression, fatigue, and ability to participate in social roles and activities compared with nonusers. In multivariable analysis, TCM use was associated with belief in TCM, female sex, ≥ 20 years of US residency, reporting Western medicine as ineffective, and shorter rheumatic disease duration.Conclusion.Among these Chinese American rheumatology patients, TCM users had worse PRO in many physical and mental health domains. TCM use may be a proxy for unmet therapeutic needs. Asking about TCM use could help providers identify patients with suboptimal health-related quality of life who may benefit from targeted interventions.

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