Table 4.
Attributes needed for assessing external validity or generalizability
| Attribute | N(%) Dossiers |
|---|---|
| N intervention centers | |
| N centers not reported | 24/290 (8.3) |
| Single center | 133/266 (50.0) |
| Multi-site | 133/266 (50.0) |
| Median number of centers (range) | 12 (2–217) |
| 2–5 centers | 40/133 (30.1) |
| 6–10 | 23/133 (17.3) |
| >10 | 70/133 (52.6) |
| Eligibility criteria for inclusion of intervention centers (multi-center trials only) | |
| Not reported | 117/133 (88.0) |
| Inclusion criteria described | 16/133 (12.0) |
| N surgeons/interventionists | |
| N interventionists not reported | 225/290 (77.6) |
| N interventionists reported | 65/290 (22.4) |
| Single interventionist | 31/65 (47.7) |
| Multiple interventionists | 34/65 (52.3) |
| Median number interventionists (range) | 3.5 (2–66) |
| 2–5 interventionists | 21/34 (61.8) |
| 6–10 | 7/34 (20.6) |
| >10 | 6/34 (17.6) |
| Eligibility criteria for inclusion of interventionists (multi-interventionist trials only) | |
| Not reported | 20/34 (58.8) |
| Inclusion criteria described | 14/34 (41.2) |
| Pre-trial standardization of operative technique (multi-interventionist trials only) | |
| Not reported | 26/34 (76.5) |
| Described critical elements of technique | 8/34 (23.5) |
| Assessment of interventionist fidelity to standardized operative technique (multi-interventionist trials only) | |
| Not reported | 31/34 (91.2) |
| Assessment method described | 3/34 (8.8) |
| Sponsor role in conduct of trial (Out of trials reporting commercial sponsorship only) | |
| Trial design | 26/89 (29.2) |
| Data analysis | 31/89 (34.8) |
| Preparation of manuscript | 29/89 (32.6) |
| Size of trial | |
| Median number of trial participants (range) | 121.5 (30–3,120) |
| 30 participants | 4/290 (1.4) |
| 31–60 | 56/290 (19.3) |
| 61–100 | 59/290 (20.3) |
| 101–200 | 63/290 (21.7) |
| >200 | 108/290 (37.2) |