Outcome Reporting Variability in Trials of Chinese Medicine for Hyperlipidemia: A Systematic Review for Developing a Core Outcome Set

Table 1

Outcome domains, definitions, number of individual outcome measurements in each domain, and frequency of outcomes reported of each domain.

Theme	Outcome domain	Definition of outcome domain	No. of outcomes	Frequency of outcomes reported
Total			452	27,328
I. Death	1. Mortality related outcomes	Outcomes related to short- and long-term survival/death rates and cause of death	2	4
II. Physiological/clinical	2. Pathological or pathophysiological outcomes	Outcomes related to the reporting of blood, or biochemical measures, within standard clinical practice or research	303	17,036
	3. Response rate related outcomes	Measures of disease recurrence or disease progression	23	2,835
	4. Cardiovascular events	Death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, unstable angina requiring hospitalization, coronary revascularization procedures, peripheral revascularization procedures, heart failure requiring hospitalization, stent thrombosis, and transient ischemic attack [1]	1	10
	5. Symptom or function related outcomes	Signs and symptoms of disease reported by clinicians	55	1,358
III. Adverse events	6. Adverse event or safety related outcomes	Forms of short-term and long-term complications	56	6,063
IV. Life impact	7. Patient-reported outcomes	Outcomes reported by patients themselves	10	19
V. Resource use	8. Resource utilization related outcomes	Economic outcomes related to healthcare	2	3

[1] Sabatine MS, Giugliano RP, Wiviott SD, et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med, 2015, 372:1500–1509.