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Table 2 Checklist for the most relevant aspects of comparative effectiveness research for Chinese medicine clinical studies

From: Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document

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