Table 2.
Overall quality of reporting rating using items from 2013 CONSORT-PRO extension items
| Item No. | Description of CONSORT-PRO criteria | No. of trials in which item was correctly reported | No. of trials in which judges were concordant (before disagreement solved) | ||
|---|---|---|---|---|---|
| n | % (95% CI) | n | % (95% CI) | ||
| Title and abstract | |||||
| P1ba | Identification of PROs in abstract as primary or secondary outcome | 11 | 27.5 (14.6-43.9) | 31 | 70.5 (54.8-83.2) |
| Introduction | |||||
| 2a | Background and rationale for PROs assessment | 14 | 31.8 (18.6-47.6) | 37 | 84.1 (69.9-93.4) |
| P2bia | Statement of PROs hypothesis | 4 | 10.0 (2.8-23.7) | 30 | 68.2 (52.4-81.4) |
| P2biia | Identification of PROs relevant domains | 1 | 2.5 (0.0-13.2) | 34 | 77.3 (62.2-88.5) |
| Methods | |||||
| 4aa | PROs used in eligibility criteria or stratification criteria | 1 | 100.0 (2.5-100.0) | 43 | 97.7 (88.0-100.0) |
| P6ai | Evidence of PRO instrument validity and reliability | 20 | 45.5 (30.4-61.2) | 36 | 81.8 (67.3-91.8) |
| P6aii | Statement of person completing PROs | 16 | 36.4 (22.4-52.2) | 34 | 77.3 (62.2-88.5) |
| P6aiii | Methods of data collection (paper, telephone, electronic, other) | 3 | 6.8 (1.4-18.7) | 41 | 93.2 (81.3-98.6) |
| 7aa | How sample size was determined (not required unless PRO is primary end point) | 2 | 100.0 (15.8-100.0) | 43 | 97.7 (88.0-100.0) |
| Randomization | |||||
| P12a | Statistical approaches for dealing with missing data are explicitly stated | 6 | 13.6 (5.2-27.4) | 34 | 77.3 (62.2-88.5) |
| Results | |||||
| 13ai | Description of number of PRO outcome data at baseline | 24 | 54.6 (38.9-69.6) | 31 | 70.5 (54.8-83.2) |
| P13aii | Description of number of PRO outcome data at subsequent time points | 19 | 43.2 (28.4-59.9) | 28 | 63.6 (47.8-77.6) |
| 15 | Table showing baseline PRO data | 16 | 36.4 (22.4-52.2) | 28 | 63.6 (47.8-77.6) |
| 16 | Number of patients included in each PRO analysis | 17 | 38.6 (24.4-54.5) | 27 | 61.4 (45.5-75.6) |
| 17a | For each targeted domain, results for each group, estimated effect size, and its precision (eg, 95% CI) | 13 | 29.6 (16.8-45.2) | 29 | 65.9 (50.1-79.5) |
| 18a | Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory | 4 | 100.0 (39.8-100.0) | 30 | 68.2 (52.4-81.4) |
| Discussion | |||||
| P20 | Limitations of PRO components explicitly discussed | 14 | 31.8 (18.6-47.6) | 35 | 79.5 (64.7-90.2) |
| P21 | Generalizability issues related to PRO results should be discussed | 12 | 27.3 (15.0-42-8) | 35 | 79.5 (64.7-90.2) |
| 22 | Clinical significance of PRO findings should be discussed | 20 | 45.5 (30.4-61.2) | 32 | 72.7 (57.2-85.0) |
PRO-specific extension statements are prefaced by the letter P.
Abbreviations: CONSORT, Consolidated Standards of Reporting Trials; PROs, patient-reported outcomes.
aPercentages calculated only among trials for which the item was applicable.