Table 2.

Checklist for the most relevant aspects of comparative effectiveness research for Chinese medicine clinical studies

Designing comparative effectiveness research (CER) studie
1. Stakeholder involvement	All relevant stakeholders are involved in identification of research topic, plan and design of CER, interpretation of results
2. Efficacy-effectiveness continuum	Location on the efficacy-effectiveness continuum is determined for participant selection/eligibility criteria, treatment protocol, practitioner expertise, outcomes, and setting in which the study is conducted
3. Study design	Designs for multi-component interventions should be considered
Study population
4. Eligibility criteria	Should be as broad as possible in the context of available resources - Study population includes both CM-naïve and CM-non- naïve patients
5. Diagnoses	Recruitment of patients should follow Western diagnoses - CM diagnoses should be done whenever possible
6. Patient recruitment	Patients are recruited from site(s) where the treatment is usually provided
Treatment, expertise, and setting
7. Defining treatments	If intervention involves multi-component treatment the combination should be plausible and feasible in usual care - non-CM best practice alternatives are based on guidelines or broad expert consensus
8. Acupuncture	See [9]
9. Qi gong/tai chi	Style and setting should reflect typical community-based programs
10. Herbal medicine	Local and national regulations should be taken into account
11. Treatment documentation	Documentation reflects which treatments were received by all groups (interventions and co-interventions)
Outcomes
12. Measures	Widely accepted or standardized outcome measure used - secondary outcomes capture relevant patient-centered dimensions for the condition under study
13. Timing	Assessment schedule is balanced allowing study to acquire relevant data without substantial disruption of treatment or setting
Study design and statistical analysis
14. Allocation	Allocation is concealed - stratification for subgroups and/or dynamic allocation for key characteristics are used
15. Blinding	Outcome data are kept inaccessible to practitioners - blinded outcome rater is used if possible
16. Preferences/expectation	Preferences and expectations are measured at baseline
17. Sample size	Sample size takes patient heterogeneity into account - required sample size is feasible - Study has enough power for planned subgroup analyses
18. Subgroups	Relevant subgroups are pre-planned - exploratory subgroup analysis is mentioned in study aims
19. Statistical analysis	Intention-to-treat analyses are planned - relevant subgroup analyses are planned - data analyses are adjusted for stratification variables, baseline differences and relevant confounders
Economic evaluations
20. Relevance	Setting reflects reality in clinical practice
21. Methodological approach	Standard methods for economic evaluations are used - sensitivity analysis is employed for all relevant stakeholder perspectives - relevant subgroups are identified
22. Observation time	Long-term observation (≥12 months) are planned if possible
Publications
23. Guidelines	Relevant guidelines (CONSORT) are consulted and followed
24. Content	Statements of how and why this is CER are included - study setting (including practitioner selection procedure) is described in detail - treatment group description from informed consent is provided - comparison groups are described in detail - data are provided on all interventions and co-interventions received - relevant subgroup analyses are reported

CM, Chinese medicine; CONSORT, Consolidated Standards of Reporting Trials.