Table 2.
Characteristics of included pragmatic trials
| Characteristic | Number of trials (n=63) |
|---|---|
| Study population | |
| Number of participants: median (IQR) | 511 (241, 822) |
| Length of follow-up in months: median (IQR) | 12 (6, 24) |
| % Female: median (IQR) | 55% (40, 64) |
| % Female excluding women’s health studies | 49% (40, 60) |
| Race/ethnicity information reported | 19 (30%) |
| Number of treatment arms | |
| 2 | 39 (62%) |
| 3 | 14 (22%) |
| 4 or more | 10 (16%) |
| Intervention | |
| Medication | 18 (29%)* |
| Surgical protocol | 13 (21%) |
| Medical device | 12 (19%)* |
| Treatment protocol | 8 (13%) |
| Counseling or therapy | 5 (8%) |
| Diagnostic test | 4 (6%) |
| Other | 4 (6%) |
| Specialty | |
| Cardiovascular disease | 8 (13%) |
| Infectious disease | 7 (11%) |
| Reproductive health | 7 (11%) |
| Primary care | 7 (11%) |
| Orthopedics | 6 (10%) |
| Psychiatry | 5 (8%) |
| Other | 23 (37%) |
| Primary outcome | |
| Symptom severity or resolution | 38 (60%) |
| Mortality or survival (including live birth) | 8 (13%) |
| Adverse events | 4 (6%) |
| Health care utilization | 4 (6%) |
| Biomarker | 4 (6%) |
| Prevention | 3 (5%) |
| Adherence | 2 (3%) |
| Primary outcome type | |
| Continuous | 28 (44%) |
| Binary | 27 (43%) |
| Time to event | 8 (13%) |
| Trial objective | |
| Superiority only | 45 (71%) |
| +safety | 9 (14%) |
| +non-inferiority | 2 (3%) |
| Non-inferiority only | 6 (10%) |
| +safety | 1 (2%) |
*
One trial assessed both medication and medical device
IQR: Interquartile range