Table 5.
PROEAS item reporting for randomized clinical trials (n = 14)a
| Variable | No. (%) |
|---|---|
| Taxonomy of research objectives | |
| PRO endpoints were specified in the trial protocol | 14 (100) |
| Hypothesis requirement was met as needed | 9 (64.3) |
| Endpoints were used to make appropriate conclusions | 9 (64.3) |
| Direction of the hypothesis was prespecified in the trial protocol if required | 9 (64.3) |
| Clinical relevance for between-group differences was prespecified in the trial protocol | 1 (7.1) |
| Within-treatment group objective stated in the trial protocol | 5 (35.7) |
| Clinical relevance for within-patient or within–treatment group change was predefined in the trial protocol | 7 (50.0) |
| Recommending statistical methods | |
| Statistical test comparing 2 groups done when appropriate | 13 (92.9) |
| Provided P values for statistical significance | 12 (85.7) |
| Tests used adjusted for baseline covariates | 13 (92.9) |
| Tests used handled clustered data (repeated assessments) | 12 (85.7) |
| Correction for multiple testing done appropriately | 3 (21.4) |
| Used at least 1 appropriate statistical test to evaluate the tested outcome | 12 (85.7) |
| Standardizing statistical terms related to missing data | |
| A definition for missing data was reported | 0 |
| Study did not consider PRO assessments for deceased patients as missing data | 1 (7.1) |
| Variable denominator rate reported | 9 (64.3) |
| Fixed denominator rate reported | 6 (42.9) |
| Absolute numbers for both numerators and denominators were reported | 11 (78.6) |
| A CONSORT diagram or table reporting reasons for treatment discontinuation was provided | 9 (64.3) |
| General handling of missing data | |
| Study documented a priori the approach for handling missing data | 4 (28.6) |
| Item-level missing data handled according to the scoring algorithm of the instrument | 3 (21.4) |
| A method that allows the use of all available data was used to approach missing data | 1 (7.1) |
| Study did not use explicit imputation methods unless justified | 7 (50.0) |
| At least 2 different approaches to handle missing data were used | 5 (35.7) |
a
CONSORT = Consolidated Standards of Reporting Trials; PRO = patient-reported outcome; PROEAS = Patient Reported Outcomes Endpoints Analysis Score; SISAQOL = Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data.