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Article: PRAgmatic Clinical Trial Design of Integrative MediCinE (PRACTICE): A Focus Group Series and Systematic Review on Trials of Diabetes and Kidney Disease

TitlePRAgmatic Clinical Trial Design of Integrative MediCinE (PRACTICE): A Focus Group Series and Systematic Review on Trials of Diabetes and Kidney Disease
Authors
Keywordsintegrative medicine
method
qualitative
pragmatic
clinical trial
Issue Date2021
PublisherFrontiers. The Journal's web site is located at http://www.frontiersin.org/Medicine
Citation
Frontiers in Medicine, 2021, v. 8, p. article no. 668913 How to Cite?
AbstractBackground: 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.
Persistent Identifierhttp://hdl.handle.net/10722/303972
ISSN
2023 Impact Factor: 3.1
2023 SCImago Journal Rankings: 0.909
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorChan, KW-
dc.contributor.authorLee, PW-
dc.contributor.authorLeung, CPS-
dc.contributor.authorLaw, YK-
dc.contributor.authorGao, L-
dc.contributor.authorChan, GCW-
dc.contributor.authorYiu, WH-
dc.contributor.authorLam, TP-
dc.contributor.authorTang, SCW-
dc.date.accessioned2021-09-23T08:53:25Z-
dc.date.available2021-09-23T08:53:25Z-
dc.date.issued2021-
dc.identifier.citationFrontiers in Medicine, 2021, v. 8, p. article no. 668913-
dc.identifier.issn2296-858X-
dc.identifier.urihttp://hdl.handle.net/10722/303972-
dc.description.abstractBackground: 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.-
dc.languageeng-
dc.publisherFrontiers. The Journal's web site is located at http://www.frontiersin.org/Medicine-
dc.relation.ispartofFrontiers in Medicine-
dc.rightsThis Document is Protected by copyright and was first published by Frontiers. All rights reserved. It is reproduced with permission.-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectintegrative medicine-
dc.subjectmethod-
dc.subjectqualitative-
dc.subjectpragmatic-
dc.subjectclinical trial-
dc.titlePRAgmatic Clinical Trial Design of Integrative MediCinE (PRACTICE): A Focus Group Series and Systematic Review on Trials of Diabetes and Kidney Disease-
dc.typeArticle-
dc.identifier.emailChan, KW: chriskwc@hku.hk-
dc.identifier.emailYiu, WH: whyiu@hku.hk-
dc.identifier.emailLam, TP: tplam@hku.hk-
dc.identifier.emailTang, SCW: scwtang@hku.hk-
dc.identifier.authorityLam, TP=rp00386-
dc.identifier.authorityTang, SCW=rp00480-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.3389/fmed.2021.668913-
dc.identifier.pmid34513860-
dc.identifier.pmcidPMC8429603-
dc.identifier.scopuseid_2-s2.0-85114815349-
dc.identifier.hkuros325546-
dc.identifier.volume8-
dc.identifier.spagearticle no. 668913-
dc.identifier.epagearticle no. 668913-
dc.identifier.isiWOS:000697591200001-
dc.publisher.placeSwitzerland-

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