Research Article: Protocol of the development of a core outcome set for stroke in multidimensional value assessment of traditional Chinese medicine
Abstract:
Introduction Stroke 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 analysis The 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 dissemination This 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.
Introduction:
Stroke is ranked as the leading cause of death in China and the second leading cause of death globally. Stroke is associated with the highest loss of disability-adjusted life years (DALYs) among all diseases. 1 Due to cerebral blood circulation disorders, it is critical to ensure blood supply to the cerebral tissue during the acute stage of stroke, particularly for acute ischaemic stroke (AIS). 2 Traditional Chinese medicine (TCM) and integrative medicine, including acupuncture, Tuina (Chinese massage), fumigation…
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