Table 1.

Checklist for CER relevant aspects for acupuncture clinical studies

Designing CER studies
Stakeholder involvement	□ All relevant stakeholders are involved in
	□ Identification of research topic
	□ Plan and design of CER
	□ Interpretation of results
Efficacy-effectiveness continuum	□ Study location on the efficacy-effectiveness continuum is determined for participant selection/eligibility criteria, treatment protocol, practitioner expertise, outcomes, setting in which the study is conducted.
Study population
Eligibility criteria	□ Study population reflects those who usually receive this treatment
	□ Study population includes both acupuncture- naïve and acupuncture-non-naïve patients
Patient recruitment	□ Patients are recruited from site where the treatment is usually employed
Treatment protocol, expertise, and setting
Acupuncture intervention	□ Adequate consensus procedure is used to define intervention
Comparison groups	□ Adequate consensus procedure used to define comparison(s)
	□ Definitions and details for terms such as “usual care” provided
Treatment documentation	□ Documentation reflects which treatments were received in all groups (interventions and co-interventions)
Outcomes
Measures	□ Widely accepted or standardized outcome measure used
	□ Secondary outcomes capture relevant patient-centered dimensions for the condition under study
Timing	□ Assessment schedule is balanced gaining study relevant data without substantially disrupting treatment protocol or setting
Study design and statistical analysis
Allocation	□ Allocation is concealed
	□ Stratification for subgroups or dynamic allocation for key characteristics used
Blinding	□ Outcome data inaccessible to practitioners
	□ Blinded outcome rater, if possible, used
Preferences/ expectation	□ Preferences and expectations measured at baseline
Sample size	□ Sample size takes patient heterogeneity into account
	□ Required sample size is feasible
	□ Study has enough power for planned subgroup analyses
Subgroups	□ Relevant subgroups preplanned (e.g. gender)
	□ Exploratory subgroup analysis mentioned in study aims
Statistical analysis	□ Intention-to-treat analyses planned
	□ Relevant subgroup analyses planned
	□ Adjusted for stratification variables, baseline differences and relevant confounders
	□ Setting reflects reality in clinical practice
Methodological approach	□ Standard methods for economic evaluations used
	□ Sensitivity analysis for all relevant stakeholder perspectives
	□ Relevant subgroups identified
Observation time	□ In chronic diseases long-term observation (≥ 12 months), if possible, planned
Guidelines	□ Relevant guidelines (e.g. CONSORT) consulted and followed
Content	□ Stated how and why this is CER
	□ Study setting (incl. procedure of practitioner selection) described in detail
	□ Treatment group description from informed consent provided
	□ Comparison groups described in detail
	□ Data provided on all interventions and co-interventions received
	□ Relevant subgroup analyses reported