Comparison of subjects’ perception of potential direct benefit and reported bases for that perception, by motivation and doctor status
| Motivation | Doctor status | |||
|---|---|---|---|---|
| Responses (n (%)) | Direct personal benefit n=54* | Altruism/dual n=35* | Own doctor n=39* | Other n=49* |
| Realistically, what do you think the chances are of your PD improving (or slowing down)? | ||||
| No chance at all | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Very low chance | 1 (1.9) | 1 (2.9) | 0 (0) | 2 (4.1) |
| Modest chance | 11 (20.4) | 9 (25.7) | 9 (23.1) | 11 (22.4) |
| Good chance | 19 (35.2) | 8 (22.9) | 12 (30.8) | 15 (30.6) |
| Very good chance | 19 (35.2) | 12 (34.3) | 14 (35.9) | 16 (32.7) |
| Gives quantitative answer greater than 50% | 2 (3.7) | 3 (8.6) | 3 (7.7) | 2 (4.1) |
| Tried not to think about it or go in with expectations | 1 (1.9) | 2 (5.7) | 1 (2.6) | 2 (4.1) |
| Other | 1 (1.9) | 0 (0) | 0 (0) | 1 (2.0) |
| What is the basis for your belief concerning the chance of benefit?† | ||||
| Information about Phase 1 results and/or Phase I related reasons (eg, through researchers, discussion w/Phase 1 subject, or own research) | 37 (40.2) | 14 (24.6) | 21 (33.3) | 28 (33.3) |
| Subject's own confidence in the science behind the procedure or some scientific aspects of the study | 12 (13.0) | 8 (14.0) | 7 (11.1) | 13 (15.5) |
| Reputation of/confidence/trust in research team; Trust in the research process in general | 9 (9.8) | 8 (14.0) | 10 (15.9) | 6 (7.1) |
| Information gathered by the subjects on their own | 12 (13.0) | 9 (15.8) | 6 (9.5) | 15 (17.9) |
| Chance benefit not stated explicitly by researchers or ICF, but inferred based on what researchers said | 3 (3.3) | 3 (5.3) | 2 (3.2) | 4 (4.8) |
| Based on fact that sponsor's invested lots of time and/or money on the study | 4 (4.3) | 1 (1.8) | 3 (4.8) | 2 (2.4) |
| Gut feeling, intuition, optimism | 8 (8.7) | 7 (12.3) | 8 (12.7) | 7 (8.3) |
| Other | 7 (7.6) | 7 (12.3) | 6 (9.5) | 9 (10.7) |
| Is this belief (chance for direct personal benefit) based on something the researchers said or did or on what you read in the informed consent?‡ | ||||
| Yes | 13 (24.5) | 2 (5.9) | 7 (18.4) | 7 (14.6) |
| No | 39 (73.6) | 29 (85.3) | 27 (71.1) | 41 (85.4) |
| Can't recall/not sure | 1 (1.9) | 3 (8.8) | 4 (10.5) | 0 (0) |
| Do you recall what the researchers told you/what the informed consent stated, in regards to your chance for benefit?§ | ||||
| Researchers were negative about likelihood of direct personal benefit or downplayed likelihood of benefit | 7 (15.9) | 2 (6.9) | 5 (15.2) | 4 (10.5) |
| Researchers were positive about likelihood of direct personal benefit | 9 (20.5) | 1 (3.4) | 5 (15.2) | 5 (13.2) |
| Researchers didn't give any specific or general indication of probability of direct personal benefit | 23 (52.3) | 23 (79.3) | 19 (57.6) | 26 (68.4) |
| Can't recall | 5 (11.4) | 3 (10.3) | 4 (12.1) | 3 (7.9) |
*Denominator varies because of missing data for some questions.
†For this question, numbers refer to comments, not subjects; some subjects made more than one comment.
‡Fisher's exact test (yes vs all other responses): direct personal benefit versus altruism/dual, p=0.04; own doctor versus other, p=0.77.
§Fisher's exact test (2×4): direct personal benefit versus altruism/dual, p=0.08; own doctor versus other, p=0.81.
PD, Parkinson's disease; ICF, informed consent form.