Comprehension of Terms Related to Clinical Trial Data
| Terms* | Codebook Definition | Accurate | Not Accurate | Did Not Know | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Overall no. (%) | Physician type | Overall no. (%) | Physician type | Overall No. (%) | Physician type | |||||
| Endo. no. (%) | PCP no. (%) | Endo. no. (%) | PCP no. (%) | Endo. no. (%) | PCP no. (%) | |||||
| N† | 72 (100.0) | 22 (100.0) | 50 (100.0) | |||||||
| Randomized controlled trial (RCT) | Participants are randomly assigned to treatment groups: control (placebo or standard treatment), experimental (receives treatment being assessed). | 45 (62.5) | 15 (68.2) | 30 (60.0) | 24 (33.3) | 7 (31.8) | 17 (34.0) | 2 (2.8) | 0 (0.0) | 2 (4.0) |
| Noninferiority RCT | Conducted to demonstrate that the new treatment is not inferior/clinically worse than standard treatment | 20 (27.8) | 5 (22.7) | 15 (30.0) | 33 (45.8) | 15 (68.2) | 18 (36.0) | 16 (22.2) | 2 (9.1) | 14 (28.0) |
| Noninferiority margin of 10% | Must explain one of the following: | 6 (8.3) | 2 (9.1) | 4 (8.0) | 31 (43.1) | 12 (54.6) | 19 (38.0) | 17 (23.6) | 5 (22.7) | 12 (24.0) |
| –If the difference in the assessed endpoint between the new treatment and the standard treatment is 10% or less, the treatments are considered equal (or the new treatment is non-inferior to, not any worse than the standard treatment). | ||||||||||
| –If the difference is more than 10%, the treatments are not equal/the new treatment is inferior. | ||||||||||
| Adjusted mean | The averages/means have been corrected to account for data imbalances (or covariates/confounding factors) that may have inherently occurred between the two groups. | 2 (2.8) | 0 (0.0) | 2 (4.0) | 24 (33.3) | 8 (36.4) | 16 (32.0) | 46 (63.9) | 14 (63.6) | 32 (64.0) |
| Rerandomization | Part way through the study, some, or all of the participants are randomly assigned again, to either their original group or the other group, for the completion of the study. | 25 (34.7) | 11 (50.0) | 14 (28.0) | 25 (34.7) | 5 (22.7) | 20 (40.0) | 22 (30.6) | 6 (27.3) | 16 (32.0) |
| Intent-to-treat analysis | Results are based on the participants' original random assignment, regardless of whether they completed the protocol or actually received the treatment (all patients enrolled are analyzed at the end of the study). | 10 (13.9) | 7 (31.8) | 3 (6.0) | 33 (45.8) | 11 (50.0) | 22 (44.0) | 28 (38.9) | 4 (18.2) | 24 (48.0) |
| Per-protocol analysis | Only those patients who completed/adhered to the study are included in the analysis. | 0 (0.0) | 0 (0.0) | 0 (0.0) | 34 (47.2) | 10 (45.5) | 24 (48.0) | 37 (51.4) | 12 (54.6) | 25 (50.0) |
| Modified intent to treat | Participants were excluded from the analysis if they did not receive a specified minimum amount of the intended intervention. | 0 (0.0) | 0 (0.0) | 0 (0.0) | 26 (36.1) | 9 (40.9) | 17 (34.0) | 44 (61.1) | 12 (54.6) | 32 (64.0) |
| Last observation carried dorward | The last data point/outcome measurement available for that particular participant is carried forward as the end point, regardless of when the measurement occurred. | 9 (12.5) | 6 (27.3) | 3 (6.0) | 19 (26.4) | 6 (27.3) | 13 (26.0) | 44 (61.1) | 10 (45.5) | 34 (68.0) |
↵* Terms were presented to participants as follow-up probes to the actual promotional materials aimed at health care providers. Responses were coded by two researchers who categorized responses as accurate, not accurate (including incomplete and partially or completely inaccurate responses), or did not know.
↵† Numbers and percentages may not add to total N or 100% due to skip patterns, rounding, and missing values. Missing values occurred due to qualitative nature of study as moderator skipped questions due to time.
Endo, endocrinologist; PCP, primary care physician