Table 4.
Prespecification of outcomes measured with BMDs in the included trials (n = 464 outcomes). For each included trial, we looked for the corresponding entry in a public clinical trial registry (e.g., ClinicalTrials.gov) by looking for the trial registration number reported in the articles on January 2020 (and June 2020 for articles added during peer-review)
| Comparison between outcome definitions in published articles and entries in public trial registries | Number of outcomes (%) | Example |
|---|---|---|
| Impossible because the trial is not registered* | 79 (17) | – |
| Outcome definition is not clear enough for comparison | 54 (14)** |
In the trial [22]: Published outcome: “MVPA was calculated using 3 axes based on 60 s epochs. Freedson-VM cut-off points were used to distinguish between light, moderate and vigorous PA.” Outcome registered: “Objective physical activity (accelerometer data)” |
| Similar outcome definitions reported in the 2 sources | 116 (30)** |
In the trial [23]: Published outcomes: “time with glucose concentration […] hyperglycemic (> 10.0 mmol/L and > 16.7 mmol/L)” Outcomes registered: “Time spent above target glucose (10.0 mmol/l) (180 mg/dl) [Time Frame: 12-week intervention phase]” and “The time with glucose levels in the significant hyperglycemia (glucose levels > 16.7 mmol/l) (300 mg/dl) [Time Frame: 12 week intervention phase]” |
| Outcome definition was modified in the published article | 11 (3)** |
In the trial [24], time frames during which BMD outcome data analyzed were modified; published outcome: “M-value (24 h […], 08.00–12.00 h […], 12.00–24.00 h […], 00.00–06.00 h […])” Outcomes registered: “M-value (24:00, 8:00–12:00, 12:00–24:00, 0:00–8:00)” |
| Outcome in the published article was not registered | 204 (53)** |
Among outcomes registered for the trial [25], only “% time within target range (3.9–10 mmol/L)” and “Incidence rate of hypoglycemic events” were registered. Published article also reported: “% time > 10 mmol/L”; “% time > 15 mmol/L” “% time > 20 mmol/L” and “Mean (SD) glucose values” |
*Including one trial for which the registration number provided in the published article linked to a different study
**Denominator is 385 outcomes for which comparison was possible (464–79)