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) |
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 |