Table 3.
NHLBI tool for quality assessment of included studies.
| Criteria | Kirch et al. (30) | Paquette et al. (31) | Stendell-Hollis et al. (32) | Woerdeman et al. (33) | Aghasi et al. (34) | Asadi et al. (35) | |
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| 1. | Was the study described as randomised, a randomised trial, a randomised clinical trial, or an RCT? |
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| 2. | Was the method of randomization adequate (i.e., use of randomly generated assignment)? |
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| 3. | Was the treatment allocation concealed (so that assignments could not be predicted)? |
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| 4. | Were study participants and providers blinded to treatment group assignment? |
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| 5. | Were the people assessing the outcomes blinded to the participants’ group assignments? |
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| 6. | Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)? |
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| 7. | Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment? |
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| 8. | Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower? |
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| 9. | 9. Was there high adherence to the intervention protocols for each treatment group? |
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| 10. | Were other interventions avoided or similar in the groups (e.g., similar background treatments)? |
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| 11. | Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants? |
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| 12. | Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power? |
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| 13. | Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)? |
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| 14. | Were all randomszed participants analysed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis? |
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+, yes;
, no;
?, cannot determine;
a, not applicable;
r, not reported.