Quality items | Adequate* | |
---|---|---|
Research protocol | N. | % |
Description of inclusion and rejection criteria for patient selection (28) | 23 | 82 |
Number and description of patients eligible not accepted (28) | 16 | 57 |
Daily amount and timing of therapeutic regimen (28) | 26 | 93 |
Physical appearance of placebo/control similar to the treatment (21) | 16 | 76 |
Taste of placebo/control similar to the treatment (21) | 10 | 48 |
Description and appropriate use of methods for assuring masking of randomization (28) | 21 | 75 |
Patients masked treatment (27) | 18 | 67 |
Observers masked to treatment (27) | 17 | 63 |
Observers masked to results (28) | 6 | 21 |
Prior estimate of sample size and power calculation (28) | 15 | 54 |
Definition of criteria for stopping the trial (28) | 11 | 39 |
Test of validity of randomization through description of relevant demographic and prognostic variables in experimental and control group (28) | 24 | 86 |
Methods used to evaluate success of masking (20) | 15 | 75 |
Methods used to ascertain compliance to treatment (0) | - | - |
Laboratory tests to evaluate absorption or pharmacological effect of the treatment (16) | 2 | 13 |
More than one observer evaluating subjective endpoints (23) | 2 | 19 |
Data analysis and presentation | Â | Â |
Start and stop dates (28) | 20 | 71 |
Analysis of results of randomization through baseline comparability of the study groups (28) | 17 | 61 |
Presentation of test statistics and P-value (28) | 26 | 93 |
Discussion of ß error in negative trials (17) | 3 | 18 |
Calculation of estimate of variance and/or confidence limits of trials endpoints (28) | 10 | 36 |
Regression/correlation analysis (25) | 12 | 48 |
Overall assessment of quality of statistical analysis (28) | 1 | 4 |
Number of patients who withdrew and the reasons why (28) | 25 | 89 |
Ways withdrawals were handled (23) | 1 | 4 |
Side effects reported and analyzed (28) | 6 | 21 |
Analysis of subgroups not specified at the beginning of the study (retrospective analysis) (28) | 2 | 7 |