Criteria | Yes | No | Other (CD,NR,NA) |
---|---|---|---|
1. Was the study question or objective clearly stated? | |||
2. Were eligibility/selection criteria for the study population prespecified and clearly described? | |||
3. Were the participants in the study representative of those who would be eligible for the test/service/intervention in the general or clinical population of interest? | |||
4. Were all eligible participants that met the prespecified entry criteria enrolled? | |||
5. Was the sample size sufficiently large to provide confidence in the findings? | |||
6. Was the test/service/intervention clearly described and delivered consistently across the study population? | |||
7. Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? | |||
8. Were the people assessing the outcomes blinded to the participants' exposures/interventions? | |||
9. Was the loss to follow-up after baseline 20% or less? Were those lost to follow-up accounted for in the analysis? | |||
10. Did the statistical methods examine changes in outcome measures from before to after the intervention? Were statistical tests done that provided p values for the pre-to-post changes? | |||
11. Were outcome measures of interest taken multiple times before the intervention and multiple times after the intervention (i.e. did they use an interrupted time-series design)? | |||
12. If the intervention was conducted at a group level (e.g. a whole hospital, a community, etc.) did the statistical analysis take into account the use of individual-level data to determine effects at the group level? |
Guidance for each question available at https://www.nhlbi.nih.gov/health-topics/study-quality-assessment-tools.
CD: cannot determine; NA: not applicable; NR: not reported.