Table 1. Design Features of the Pragmatic Randomized Clinical Trials.
| Features | Trials, No. (%) (N = 73) |
|---|---|
| No. of sites | |
| Single center | 24 (33) |
| 2-5 | 9 (12) |
| 6-10 | 11 (15) |
| 11-20 | 7 (10) |
| 21-50 | 13 (18) |
| >50 | 8 (11) |
| Missing data | 1 (1) |
| Country | |
| United Kingdom | 29 (40) |
| United States | 16 (22) |
| The Netherlands | 4 (5) |
| 18 Other countries | 22 (30) |
| >1 Country | 2 (3) |
| Design | |
| Participant-level RCT | 63 (86) |
| Cluster RCT | 10 (14) |
| No. of participants enrolled | |
| <200 | 22 (30) |
| 200-500 | 21 (29) |
| >500 | 30 (41) |
| Length of follow-up, mo | |
| <6 | 25 (34) |
| 6-12 | 31 (43) |
| 13-18 | 6 (8) |
| >18 | 11 (15) |
| No. of arms | |
| 2 | 64 (88) |
| ≥3 | 9 (12) |
| Blinding | |
| Assessor | 31 (43) |
| Double | 5 (7) |
| Participants only | 1 (1) |
| None | 36 (49) |
| Recruitment embedded in health care | |
| Yes | 33 (45) |
| No: Identification through records and invitations | 16 (22) |
| No: Use of advertisements | 7 (10) |
| Unclear | 17 (23) |
| Use of EHR | |
| To recruit and collect data | 7 (10) |
| To recruit | 7 (10) |
| To collect data | 4 (5) |
| Mention of medical records but unclear if EHR | 13 (18) |
| Unclear | 33 (45) |
| Clearly nonea | 9 (12) |
| Type of primary end points used | |
| Clinical | 23 (32) |
| Clinical but self-reported | 12 (16) |
| Diagnostic questionnaires | 11 (15) |
| Quality-of-life scales/questionnaires | 10 (14) |
| Composite | 2 (3) |
| Surrogate | 6 (8) |
| Multiple pimary end points | 5 (7) |
| Others | 4 (5) |
| Therapeutic area | |
| Psychiatry/addiction | 18 (25) |
| Cardiovascular | 8 (11) |
| Gynecology/obstetrics | 5 (7) |
| Infectious diseases | 5 (7) |
| Others | 37 (51) |
| Interventions | |
| Care managementb | 23 (32) |
| Medicines (drugs, biologics) | 11 (15) |
| Psychotherapy | 11 (15) |
| Lifestylec | 4 (5) |
| Professional training | 4 (5) |
| Other | 20 (27) |
| Control | |
| Usual care | 32 (44) |
| Different mode of administration | 26 (36) |
| Different nature of intervention | 6 (8) |
| No intervention or wait-list | 6 (8) |
| Placebo | 1 (1) |
| Different administration or technique plus placebo | 2 (3) |
| Funding source | |
| Public | 58 (79) |
| Public, but supplies provided by industry | 6 (8) |
| Private foundation | 4 (6) |
| Industry | 4 (6) |
| Public and private foundations | 1 (1) |
Abbreviations: EHR, electronic health record; RCT, randomized clinical trial.
a
Three trials were performed involving health care professionals with no health-related outcomes and did not require the use of EHRs.
b
Five trials were performed using only the internet or the phone as an interface.
c
Two trials were performed using only the internet.