Table 1: Modified Downs and Black checklist.
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Reporting |
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1. Is the objective of the study clearly described? |
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2. Are the main outcomes to be measured clearly described in the Introduction or Methods section? |
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3. Were inclusion and exclusion criteria clearly stated? |
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4. Are the characteristics of the patients included clearly described? |
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5. Is the Class III malocclusion fully described? |
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6. Are the interventions of interest clearly described? |
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7. Are the distributors of principal confounders in each group of subjects to be compared clearly described? |
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8. Are the main findings of the study clearly described? |
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9. Does the study provide estimates of the random variability in the data for the main outcomes? |
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10. Have all important adverse events that may be a consequence of the intervention been reported? |
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11. Have the characteristics of patients lost to follow-up been described? |
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12. Have actual probability values been reported for the main outcomes except where the probability value is less than 0.001? |
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External validity |
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13. Were the patients asked to participate in the study representative of the entire population from which they were recruited? |
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14. Were those subjects who were prepared to participate representative of the entire population from which they were recruited? |
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15. Were the staff, places, and facilities where the patients were treated, representative of the treatment the majority of patients receive? |
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Internal validity – bias |
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16. Was an attempt made to blind those measuring the main outcome of the intervention? |
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17. If any of the results of the study were based on “data dredging”, was that made clear? |
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18. Do the analyses adjust for different lengths of follow-up of patients? |
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19. Were the statistical tests used to assess the main outcomes appropriate? |
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20. Was compliance with the intervention reliable? |
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21. Were the main outcomes measures used accurate (valid and reliable)? |
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Internal validity – confounding |
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22. Were the patients in different intervention groups recruited from the same population? |
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23. Were the baseline characteristics comparable? |
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24. Were study subjects in different intervention groups recruited over the same period of time? |
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25. Was there adequate adjustment for confounding in the analyses from which the main findings were drawn? |
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26. Were losses of patients to follow-up taken into account? |
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Power |
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27. Prior estimate of sample size |