Development of a Core Outcome Set in the Clinical Trials of Traditional Chinese Medicine for Stroke: A Study Protocol

Zhang, Ting; Li, Xuechao; Zhao, Liang; Zhang, Jiaoyan; Tian, Jinhui; Zhang, Junhua

doi:10.3389/fmed.2022.753138

Cited by 4 publications

(8 citation statements)

References 34 publications

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“…Although several COS have been developed for stroke,8 9 32–34 most have focused on western medicine32–34 or evaluated the clinical effectiveness of TCM therapy 8 9. Because clinical trials and HTA have very different purposes, there are substantial discrepancies in the selection of outcome set.…”

Section: Discussionmentioning

confidence: 99%

“…Extensive clinical trials and systematic reviews have been conducted to assess the effectiveness, safety and economics of TCM/integrative medicines in the treatment of stroke. However, the number of clinical studies that can provide high-quality evidence remains limited7 mainly because of substantial variations in the outcome measures used in clinical studies 8–10. For western medicine, the Core Outcome Measures in Effectiveness Trials (COMET) initiative has promoted the application of core outcome sets (COS),11 to improve the consensus on the selection of outcome measurements used in clinical trials.…”

Section: Introductionmentioning

confidence: 99%

“…Generally, the COS identify the minimum set of outcomes that should be measured and reported in clinical trials of a specific disease. To address the heterogeneity in measuring and reporting outcomes in TCM, some COS have been developed specifically for TCM clinical trials but with limited emphasis on TCM syndromes 8 9…”

Section: Introductionmentioning

confidence: 99%

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Protocol of the development of a core outcome set for stroke in multidimensional value assessment of traditional Chinese medicine

Yuan,

Yang,

et al. 2024

BMJ Open

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IntroductionStroke is the most common cause of death in China. In Chinese clinical practise, traditional Chinese medicine (TCM) and integrative medicine have been widely used as adjuvant therapies for the treatment of stroke. However, their clinical effectiveness, particularly their clinical value, has been inconsistent in the literature mainly because various outcome measures have been used and reported in clinical research. Hence, obtaining a comprehensive list of outcomes for TCM value assessment is crucial for a multidimensional value assessment. Therefore, the main objective of this protocol was to develop an outcome set used in health technology assessment (HTA) decision-making for TCM treatment of stroke.Methods and analysisThe outcome set will be developed in four phases: (1) we will perform a systematic literature review to identify candidate outcomes that have been previously measured in published studies; (2) we will develop a comprehensive list of outcome measures by conducting a multistakeholder semistructured interview; (3) we will conduct two-round Delphi surveys to prioritise outcomes for each HTA domain; and (4) we will finalise the outcome sets by holding a ratification meeting with multiple stakeholder groups. The developed outcome set should be measured and reported as the minimum set of outcomes for HTA assessment for the TCM treatment of acute ischaemic stroke (AIS).Ethics and disseminationThis protocol was reviewed and approved by the Institutional Review Board of the Minhang Hospital of Fudan University. Our findings will be shared at academic conferences and in peer-reviewed publications.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Protocol of the development of a core outcome set for stroke in multidimensional value assessment of traditional Chinese medicine

Yuan,

Yang,

et al. 2024

BMJ Open

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“…This study systematically evaluated the clinical RCTs of TCM in addressing DPN, a significant complication of diabetes, using an evidence mapping approach. Despite the breadth of studies in this area, challenges such as inconsistent trial designs, predominant focus on standalone TCM treatments, varied intervention methods, and restricted evaluation metrics remain ( Zhang et al, 2021 ).…”

Section: Discussionmentioning

confidence: 99%

Evidence mapping of traditional Chinese medicine in diabetic peripheral neuropathy treatment

Fu,

Wang,

et al. 2024

Front. Pharmacol.

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Objective: Diabetic peripheral neuropathy (DPN) stands as a crucial complication of diabetes, significantly affecting patients’ quality of life. This study aims to elucidate the evidence distribution from clinical randomized controlled trials (RCTs) on DPN treatment with traditional Chinese medicine (TCM) through evidence mapping.Methods: A comprehensive search was conducted from January 2017 to October 2022 in databases such as Wanfang (China Online Journals), CNKI (China National Knowledge Infrastructure), VIP (China Science and Technology Journal Database), SinoMed (Chinese Biomedical Literature Database), PubMed, Web of Science, and Cochrane Library. Literature related to the treatment of DPN with TCM was selected. From the 1,229 RCTs identified over the past 6 years, relevant data were extracted. The evidence mapping approach was utilized, and trends in publications, study scales, intervention types, and evaluation indicators were analyzed using descriptive text combined with tables and bubble charts.Results: Research on the treatment of DPN with TCM is extensive. The publication trend remains relatively stable with predominantly smaller sample sizes. The main treatments encompass oral Chinese medicine and traditional external treatments. The most common evaluation indicators are neurophysiological, efficiency rate, symptom signs, neuropathy scores, and traditional Chinese symptoms, with less focus on psychological status and the ankle-brachial index (ABI).Conclusion: Shedding light on contemporary research, this study explores the current RCTs evaluating TCM’s efficacy in treating DPN. The findings not only highlight the potential role of TCM in addressing diabetic complications but also underscore areas that could benefit from refined research approaches, expanded intervention methods, and broader assessment criteria. Our observations aim to inform and inspire future research directions and clinical practices concerning TCM’s role in managing diabetes-associated complications.

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“…There is no consensus on the optimal sample size for the Delphi study, and based on the content of published literature, sample sizes for health professionals typically range from 30 to 120 participants [22,25,26]. In this study, following the research purpose of the project, we adhered to the principles of authority, representativeness, and regionality.…”

Section: Samplingmentioning

confidence: 99%

Developing a Core Outcome Set for Assessing Clinical Safety Outcomes of Prostate Cancer in Clinical Trials of Traditional Chinese Medicine: Protocol for a Mixed Methods Study (Preprint)

Tian,

Zhang,

Ren

et al. 2023

Preprint

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BACKGROUND Among the common malignant tumors in men worldwide, the incidence of prostate cancer ranks second to lung cancer. This disease will bring an economic burden to patients and their families and can reduce the quality of life of patients. Researchers have conducted numerous clinical trials on the efficacy and safety of different interventions in the treatment of prostate cancer with traditional Chinese medicine (TCM) combined with standard treatment regimens. However, the currently published clinical trials exhibit inconsistent and irregular reporting of outcome measures. OBJECTIVE The objective of this paper is to emphasize the need for a core outcome set (COS) to facilitate future prostate cancer research, aiming to improve the quality of trials and generate high-quality evidence. METHODS This mixed methods project has three phases, as follows: (1) a scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of interventions involving TCM for the treatment of prostate cancer as well as a qualitative component using interviews to obtain the views of patients with prostate cancer, their families, and their caregivers who have a history of TCM treatment; (2) a Delphi survey among stakeholders to prioritize the core outcomes—Participants will include traditional Chinese and Western medicine clinicians in prostate cancer–related directions, nurses, and methodology experts who will participate in 2 rounds of the Delphi method expert consultation to score each outcome in the list of outcome indicators; and (3) a face-to-face consensus meeting to discuss and agree on the final COS for the application of TCM in the treatment of prostate cancer. RESULTS The protocol has been registered in PROSPERO (CRD42022356184) before the start of the review process, and we will initiate the review on August 1, 2023; results should be expected by September 1, 2023. The Delphi survey among stakeholders is expected to start in October 2023. CONCLUSIONS The development of a core outcome set for assessing clinical safety outcomes of prostate cancer in clinical trials of TCM will provide a significant first step to assist Chinese doctors, researchers, and policy makers. CLINICALTRIAL PROSPERO CRD42022356184; https://tinyurl.com/ysakz74r INTERNATIONAL REGISTERED REPORT PRR1-10.2196/46794

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Development of a Core Outcome Set in the Clinical Trials of Traditional Chinese Medicine for Stroke: A Study Protocol

Cited by 4 publications

References 34 publications

Protocol of the development of a core outcome set for stroke in multidimensional value assessment of traditional Chinese medicine

Protocol of the development of a core outcome set for stroke in multidimensional value assessment of traditional Chinese medicine

Evidence mapping of traditional Chinese medicine in diabetic peripheral neuropathy treatment

Developing a Core Outcome Set for Assessing Clinical Safety Outcomes of Prostate Cancer in Clinical Trials of Traditional Chinese Medicine: Protocol for a Mixed Methods Study (Preprint)

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