Table 4.
The Downs and Black Quality List [108].
| Subscale | Item | Index | Score | |||||
|---|---|---|---|---|---|---|---|---|
| 5 | 4 | 3 | 2 | 1 | 0 | |||
| Reporting | 1 | Is the hypothesis/aim/objective of the study clearly described? | - | - | - | - | Y | N |
| 2 | Are the main outcomes to be measured clearly described in the Introduction or Methods section? | - | - | - | - | Y | N | |
| 3 | Are the characteristics of the patients included in the study clearly described? | - | - | - | - | Y | N | |
| 4 | Are the interventions of interest clearly described? | - | - | - | - | Y | N | |
| 5 | Are the distributions of principal confounders in each group of subjects to be compared clearly described? | - | - | - | Y | P | N | |
| 6 | Are the main findings of the study clearly described? | - | - | - | - | Y | N | |
| 7 | Does the study provide estimates of the random variability in the data for the main outcomes? | - | - | - | - | Y | N | |
| 8 | Have all important adverse events that may be a consequence of the intervention been reported? | - | - | - | - | Y | N | |
| 9 | Have the characteristics of patients lost to follow-up been described? | - | - | - | - | Y | N | |
| 10 | Have actual probability values been reported (e.g., 0.035 rather than <0.05) for the main outcomes except where the probability value is less than 0.001? | - | - | - | - | Y | N | |
| External Validity | 11 | Were the subjects asked to participate in the study representative of the entire population from which they were recruited? | - | - | - | - | Y | N/UD |
| 12 | Were those subjects who were prepared to participate representative of the entire population from which they were recruited? | - | - | - | - | Y | N/UD | |
| 13 | Were the staff, places, and facilities where the patients were treated, representative of the treatment the majority of patients receive? | - | - | - | - | Y | N/UD | |
| Internal Validity-Bias | 14 | Was an attempt made to blind study subjects to the intervention they have received? | - | - | - | - | Y | N/UD |
| 15 | Was an attempt made to blind those measuring the main outcomes of the intervention? | - | - | - | - | Y | N/UD | |
| 16 | If any of the results of the study were based on “data dredging”, was this made clear? | - | - | - | - | Y | N/UD | |
| 17 | In trials and cohort studies, do the analyses adjust for different lengths of follow-up of patients, or in case-control studies, is the time period between the intervention and outcome the same for cases and controls? | - | - | - | - | Y | N/UD | |
| 18 | Were the statistical tests used to assess the main outcomes appropriate? | - | - | - | - | Y | N/UD | |
| 19 | Was compliance with the intervention/s reliable? | - | - | - | - | Y | N/UD | |
| 20 | Were the main outcome measures used accurate (valid and reliable)? | - | - | - | - | Y | N/UD | |
| Internal Validity-Confounding (Selection Bias) | 21 | Were the patients in different intervention groups (trials and cohort studies) or were the cases and controls (case-control studies) recruited from the same population? | - | - | - | - | Y | N/UD |
| 22 | Were study subjects in different intervention groups (trials and cohort studies) or were the cases and controls (case-control studies) recruited over the same period of time? | - | - | - | - | Y | N/UD | |
| 23 | Were study subjects randomised to intervention groups? | - | - | - | - | Y | N/UD | |
| 24 | Was the randomised intervention assignment concealed from both patients and health care staff until recruitment was complete and irrevocable? | - | - | - | - | Y | N/UD | |
| 25 | Was there adequate adjustment for confounding in the analyses from which the main findings were drawn? | - | - | - | - | Y | N/UD | |
| 26 | Were losses of patients to follow-up taken into account? | - | - | - | - | Y | N/UD | |
| Power | 27 | Did the study have sufficient power to detect a clinically important effect where the probability value for a difference being due to chance is less than 5%? | Size of smallest intervention group | |||||
| > n8 | n7 − n8 | n5 − n6 | n3 − n4 | n1 − n2 | < n1 | |||
-Note: Y: yes; P: partially; N: no; UD: unable to determine.