|
| Section 1: Internal validity* |
|
| Item | Description |
|
| 1.1 | Study addresses appropriate, clearly focused question. |
| 1.2 | Treatment group assignment is randomized. |
| 1.3 | Adequate concealment method is used. |
| 1.4 | Subjects and investigators are kept “blind” about treatment allocation. |
| 1.5 | Treatment and control groups are similar at the start of the trial. |
| 1.6 | Only difference between groups is the treatment under investigation. |
| 1.7 | Outcomes are measured in a standard, valid, and reliable way. |
| 1.8 | What percentage of subjects in each treatment arm dropped out before the study was completed (i.e., record %)? |
| 1.9 | All subjects are analyzed in the groups to which they were randomly allocated (intention to treat analysis). |
| 1.10 | If the study is multisite, results are comparable for all sites. |
|
|
Section 2: Overall assessment** |
|
|
How well was the study done to minimize bias? How valid is the study? Code ++, +, or − |
|
|
*Each item in Section 1 is to be evaluated using these criteria: |
| (i) | Well covered |
| (ii) | Adequately addressed |
| (iii) | Poorly addressed |
| (iv) | Not addressed (i.e., not mentioned, or indicates that this aspect was ignored) |
| (v) | Not reported (i.e., mentioned, but insufficient detail to allow assessment) |
| (vi) | Not applicable |
|
|
**The overall assessment uses the following ratings. |
| ++ | All or most of the criteria have been fulfilled. Where they have not been fulfilled the conclusions of the study or review are thought very unlikely to alter. |
| + | Some of the criteria have been fulfilled. Those criteria that have not been fulfilled or not adequately described are thought unlikely to alter the conclusions. |
| − | Few or no criteria fulfilled. The conclusions of the study are thought likely or very likely to alter. |
|
