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1. Was the study question or objective clearly stated? |
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2. Were eligibility/selection criteria for the study population prespecified and clearly described? |
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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? |
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4. Were all eligible participants that met the prespecified entry criteria enrolled? |
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5. Was the sample size sufficiently large to provide confidence in the findings? |
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6. Was the test/service/intervention clearly described and delivered consistently across the study population? |
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7. Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? |
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8. Were the people assessing the outcomes blinded to the participants' exposures/interventions? |
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9. Was the loss to follow-up after baseline 20% or less? Were those lost to follow-up accounted for in the analysis? |
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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? |
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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)? |
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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? |
Prospective cohort study design23
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Selection |
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1) Representativeness of the exposed cohort |
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2) Selection of the non-exposed cohort |
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3) Ascertainment of exposure |
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4) Demonstration that outcome of interest was not present at the start of the study |
Comparability |
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1) Comparability of cohorts on the basis of the design or analysis controlled for confounders |
Outcome |
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1) Assessment of outcome |
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2) Was follow-up long enough for outcomes to occur |
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3) Adequacy of follow-up of cohorts |
Randomized controlled trial study design22
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1) Random sequence generation |
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2) Allocation concealment |
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3) Selective reporting |
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4) Other sources of bias |
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5) Blinding (participants and personnel) |
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6) Blinding (outcome assessment) |
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7) Incomplete outcome |