Completion of CONSORT-PRO checklist by primary and secondary outcome designation
| CONSORT-PRO item | Primary outcome 7 (24.14) | Secondary outcome 22 (75.86) | Total 29 (100) | |||
| Complete | Not complete | Complete | Not complete | Complete | Not complete | |
| n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
| Introduction | ||||||
| P1b. Abstract—PRO as primary/secondary endpoint* | 7 (100) | 0 (0) | 10 (45.45) | 12 (54.55) | 17 (58.62) | 12 (41.38) |
| 2a. Rationale for including PRO endpoint (1) | 4 (57.14) | 3 (42.86) | 7 (31.82) | 15 (68.18) | 11 (37.93) | 18 (62.07) |
| P2bi. PRO hypothesis present (0.5) | 0 (0) | 7 (100) | 2 (9.09) | 20 (90.91) | 2 (6.9) | 27 (93.1) |
| P2bii. PRO domains in hypothesis (0.5) | 0 (0) | 7 (100) | 0 (0) | 22 (100) | 0 (0) | 29 (100) |
| Methods | ||||||
| P6ai. Evidence of PRO instrument validity | 7 (100) | 0 (0) | 19 (86.36) | 3 (13.64) | 26 (89.66) | 3 (10.34) |
| P6aii. Statement of the person completing the questionnaire | 5 (71.43) | 2 (28.57) | 9 (40.91) | 13 (59.09) | 14 (48.28) | 15 (51.72) |
| P6aiii. Mode of administration (paper, e-PRO) | 0 (0) | 7 (100) | 1 (4.55) | 21 (95.45) | 1 (3.45) | 28 (96.55) |
| P7a. How sample size was determined (not required unless PRO is a primary endpoint)* | 5 (71.43) | 2 (28.57) | – | – | 5 (71.43) | 2 (28.57) |
| P12a. Statistical approach for dealing with missing data (imputation, exclusion, other) | 1 (14.29) | 6 (85.71) | 4 (18.18) | 18 (81.82) | 5 (17.24) | 24 (82.76) |
| Results | ||||||
| 13ai. Report no. questionnaires submitted/available for analysis at baseline | 3 (42.86) | 4 (57.14) | 12 (54.55) | 10 (45.45) | 15 (51.72) | 14 (48.28) |
| 13aii. Report no. questionnaires submitted/available for analysis principal time point for analysis | 2 (28.57) | 5 (71.43) | 8 (36.36) | 14 (63.64) | 10 (34.48) | 19 (65.52) |
| 15.Demographics table includes baseline PRO | 6 (85.71) | 1 (14.29) | 20 (90.91) | 2 (9.09) | 26 (89.66) | 3 (10.34) |
| 16.Number of pts (denominator) included in each PRO analysis | 1 (14.29) | 6 (85.71) | 7 (31.82) | 15 (68.18) | 8 (27.59) | 21 (72.41) |
| 17ai. PRO results reported for the hypothesized domains and time point specified in the hypothesis—OR—reported for each domain of the PRO questionnaire if no PRO hypothesis provided | 2 (28.57) | 5 (71.43) | 4 (18.18) | 18 (81.82) | 6 (20.69) | 23 (79.31) |
| 17aii. Results include CI, effect size or some other estimate of precision | 7 (100) | 0 (0) | 18 (81.82) | 4 (18.18) | 25 (86.21) | 4 (13.79) |
| 18.Results of any subgroup/adjusted/exploratory analyses | 5 (71.43) | 2 (28.57) | 6 (27.27) | 16 (72.73) | 11 (37.93) | 18 (62.07) |
| Discussion | ||||||
| P20. PRO study limitations | 7 (100) | 0 (0) | 16 (72.73) | 6 (27.27) | 23 (79.31) | 6 (20.69) |
| P21. Implications of PRO results for generalizability, clinical practice | 4 (57.14) | 3 (42.86) | 8 (36.36) | 14 (63.64) | 12 (41.38) | 17 (58.62) |
| 22.PROs interpreted in relation to clinical outcomes | 6 (85.71) | 1 (14.29) | 7 (31.82) | 15 (68.18) | 13 (44.83) | 16 (55.17) |
*Item P7a only applies to PROs identified as a primary outcome.
CONSORT, Consolidated Standards of Reporting Trials; PRO, patient-reported outcome.