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 | |