Table 1.
PROEAS items and the SISAQOL recommended statements they are derived from
| SISAQOL statement | PROEAS item | Points |
|---|---|---|
| Taxonomy of research objectives (7 points) | ||
| RS 1 | PRO endpoints were specified in the protocol | 1 |
| Hypothesis requirement was met as neededa | 1 | |
| Endpoints were used to make appropriate conclusionsb | 1 | |
| RS 2 | Direction of the hypothesis was prespecified in the protocol if required | 1 |
| Clinical relevance for between-group differences was prespecified in the protocol | 1 | |
| RS 3–8 | Within-treatment group objective stated in the protocol | 1 |
| Clinical relevance for within-patient or within–treatment group change was predefined in the protocol | 1 | |
| Recommending statistical methods (6 points) | ||
| RS 10 | Statistical test comparing 2 groups done when appropriate | 1 |
| Provided P values for statistical significance | 1 | |
| Tests used adjusted for baseline covariates | 1 | |
| Tests used handled clustered data (repeated assessments) | 1 | |
| Correction for multiple testing done appropriately | 1 | |
| RS 11–15 | Used at least 1 appropriate statistical test to evaluate the tested outcomec | 1 |
| Standardizing statistical terms related to missing data (6 points) | ||
| RS 16 | A definition for missing data was reported | 1 |
| RS 18 | Study did not consider PRO assessments for deceased patients as missing data | 1 |
| RS 21–22 | Variable denominator rate reported | 1 |
| RS 19–20 | Fixed denominator rate reported | 1 |
| RS 23 | Absolute number for both numerators and denominators were reported | 1 |
| A CONSORT diagram or table reporting reasons for treatment discontinuation was provided | 1 | |
| General handling of missing data (5 points) | ||
| RS 27 | Study documented a priori the approach for handling missing data | 1 |
| RS 28 | Item-level missing data handled according to the scoring algorithm of the instrument | 1 |
| RS 30 | A method that allows the use of all available data was used to approach missing data | 1 |
| RS 31 | Study did not use explicit imputation methods unless justified | 1 |
| RS 32 | At least 2 different approaches to handle missing data were used | 1 |
a
A hypothesis statement was required if PROs were a secondary endpoint and not required if PROs were an exploratory endpoint. CONSORT = Consolidated Standards of Reporting Trials; PRO = patient-reported outcome; PROEAS = Patient Reported Outcomes Endpoints Analysis Score; RS = recommended statement; SISAQOL = Standards in Analyzing Patient-Reported Outcomes and Quality of Life.
b
Comparative conclusions were considered appropriate if PROs were a primary or secondary endpoint only and inappropriate if PROs were exploratory endpoints.
c
Statistical tests were considered appropriate if they met the recommendations of the SISAQOL.