Table 3.
Reporting standards for PRO data [11]
| Number of PROs n = 35 (%) | |
|---|---|
| PROs identified in the abstract as a primary or secondary outcome | 9 (25.7) |
| Rationale for PRO assessment provided | 9 (25.7) |
| PRO hypothesis stated in background/objectives | 5 (14.3) |
| PROs used in eligibility/stratification criteria | 0 (0) |
| Evidence of chosen PRO instrument’s validity and reliability provided | 7 (20) |
| Reporting of the person completing the PRO: | 19 (54.3) |
| Method of data collection | |
| Paper | 13 (37.1) |
| Telephone | 1 (2.9) |
| Electronic | 0 (0) |
| Other | 1 (2.9) |
| Not reported | 20 (57.1) |
| Explicit statement of statistical approaches for dealing with missing data | 1 (2.9) |
| Baseline data collected | 11 (31.4) |
| Reporting of number of patients completing PROMs at follow-upa | 13 (13.1) |
| Additional analyses reported, included distinction between pre-specified and exploratory | 0 (0) |
| PRO-specific limitations provided | 8 (22.6) |
| PRO data interpreted alongside clinical outcomes | 27 (74.3) |
aFrom 99 follow-up time points