Table 1 Phase III item-reduced checklist assessed using the within-Task Force pilot
Primary or secondary | Items | Score 1 = ”yes”; 0 = ”no” | Reviewer comments |
|---|---|---|---|
Background/relevance: 3 items (1 primary, 2 secondary) | |||
Primary | 1. Clear underlying hypotheses and specific research questions | ||
Secondary | 2. Relevant population and setting | ||
Secondary | 3. Relevant interventions and outcomes are included | ||
Design 4 items: (2 primary, 2 secondary) | |||
Primary | 1. Evidence of a priori protocol, review of analyses, statistical analysis plan, and interpretation of results | ||
Primary | 2. Comparison groups justified | ||
Secondary | 3. Registration in a public repository with commitment to publish results | ||
Secondary | 4. Data sources that are sufficient to support the studya | ||
Measures: 4 items (2 primary, 2 secondary) | |||
Primary | 1. Was exposure clearly defined, measured and (relevance) justifiedb | ||
Primary | 2. Primary outcomes defined, measured and (relevance) justifiedb | ||
Secondary | 3. Length of observation: Sufficient follow up duration to reliably assess outcomes of interest and long-term treatment effects | ||
Secondary | 4. Sample size: calculated based on clear a priori hypotheses regarding the occurrence of outcomes of interest and target effect of studied treatment versus comparator | ||
Analyses 3 items (1 primary, 2 secondary) | |||
Primary | 1. Thorough assessment of and mitigation strategy for potential confounders | ||
Secondary | 2. Study groups are compared at baseline and analyses of subgroups or interaction effects reported | ||
Secondary | 3. Sensitivity analyses are performed to check the robustness of results and the effects of key assumptions on definitions or outcomes | ||
Results/reporting: 6 items (2 primary, 4 secondary) | |||
Primary | 1. Extensive presentation of results/authors describe the key components of their statistical approachesa | ||
Primary | 2. Were confounder-adjusted estimates of treatment effects reportedb | ||
Secondary | 3. Flow chart explaining all exclusions and individuals screened or selected at each stage of defining the final sample | ||
Secondary | 4. Was follow-up similar or accounted for between groups | ||
Secondary | 5. Did the authors describe the statistical uncertainty of their findings | ||
Secondary | 6. Was the extent of missing data reported | ||
Discussion/interpretation: 4 items (2 primary, 2 Secondary) | |||
Primary | 1. Results consistent with known information or if not, was an explanation provided | ||
Primary | 2. Are the observed treatment effects considered clinically meaningful | ||
Secondary | 3. Discussion of possible biases and confounding factors, especially related to the observational nature of the study | ||
Secondary | 4. Suggestions for future research to challenge, strengthen, or extend the study results | ||
Conflict of interest: (1 primary item) | |||
Primary | 1. Potential conflicts of interest, including study funding, were stated | ||