Protocol of the Development of a Core Outcome Set for Ischemic Stroke in Clinical Trials of Chinese Medicine

Table 1

The COS-STAD recommendations.

Domains	No.	Methodology	Notes
Scope specification	1	The research or practice setting(s) in which the COS is to be applied.	The IS-CM-COS will be applied in research studies or routine clinical care.
	2	The health condition(s) covered by the COS.	The disease covered by the COS will be ischemic stroke.
	3	The population(s) covered by the COS.	The target patients will be all adults aged above 18 years old with ischemic stroke of different stages.
	4	The intervention(s) covered by the COS.	The interventions that will be covered by the COS are CM-related therapies.
Stakeholders involved	5	Those who will use the COS in research.	CM clinical researchers, methodologists, statistical experts, etc., will participate in the COS development.
	6	Healthcare professionals with experience of patients with the condition.	Healthcare professionals will include CM clinical experts, neurologists, and nurses.
	7	Patients with the condition or their representatives.	Patients with ischemic stroke will be included in the COS development.
Consensus process	8	The initial list of outcomes considered both healthcare professionals’ and patients’ views.	The initial list of outcomes included in the COS will be identified through a systemic literature review and interviews.
	9	A scoring process and consensus definition were described a priori.	A Delphi survey and consensus meeting will be adopted to select the outcomes.
	10	Criteria for including/dropping/adding outcomes were described a priori.	The criteria for including, dropping, or adding new outcomes will be the 9-point Likert scale recommended by the GRADE working group.
	11	Care was taken to avoid ambiguity of language used in the list of outcomes.	The language and medical terms in our COS will ensure uniformity of the outcome terms.

Note. Our COS will be developed following the above 11 standards. The 11 minimum reporting standards are recommended to evaluate the methodology quality of the COS study. COS: core outcome set; GRADE: Grading of Recommendations Assessment, Development and Evaluation; and CM: Chinese medicine.