Table 7 Quality rating by applying the NHLBI study quality assessment tool for before-after studies
Question | Yes | No | Cannot Determine/Not-recorded/Not-Available |
|---|---|---|---|
1. Was the study question or objective clearly stated? | 45 | 1 | 0 |
2. Were eligibility/selection criteria for the study population prespecified and clearly described? | 44 | 2 | 0 |
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? | 46 | 0 | 0 |
4. Were all eligible participants that met the prespecified entry criteria enrolled? | 14 | 13 | 19 |
5. Was the sample size sufficiently large to provide confidence in the findings? | 10 | 5 | 31 |
6. Was the test/service/intervention clearly described and delivered consistently across the study population? | 40 | 6 | 0 |
7. Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? | 46 | 0 | 0 |
8. Were the people assessing the outcomes blinded to the participants' exposures/interventions? | 0 | 46 | 0 |
9. Was the loss to follow-up after baseline 20% or less? Were those lost to follow-up accounted for in the analysis? | 34 | 4 | 8 |
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? | 45 | 1 | 0 |
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)? | 34 | 11 | 1 |
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? | 0 | 1 | 45 |