Table 2.
Percent of Respondents Who Answered Correctly to Understanding Items by Scenario
| Scenarioa | Commonly Usedb | Random Assignmentc | Extra Thingsd | |||
|---|---|---|---|---|---|---|
| Percent (95% CI) | pe | Percent (95% CI) | pe | Percent (95% CI) | pe | |
| Medical Records: Blood Clot |
77 (73–81) | 0.01 | 24 (20–28) | 0.31 | 57 (52–62) | 0.31 |
| GN | 85 (78–92) | 29 (20–38) | 60 (51–70) | |||
| O | 77 (69–85) | 18 (11–26) | 53 (43–63) | |||
| O+I | 80 (72–88) | 22 (13–30) | 51 (41–61) | |||
| WC-MR | 66 (57–75) | 25 (17–33) | 62 (53–71) | |||
| Medical Records: UTI |
80 (76–84) | 0.08 | 23 (19–27) | 0.38 | 56 (51–60) | 0.67 |
| GN | 72 (64–81) | 28 (19–36) | 53 (43–62) | |||
| O | 86 (79–92) | 25 (17–33) | 61 (51–70) | |||
| O + I | 83 (76–91) | 20 (12–27) | 56 (46–66) | |||
| MC - MR | 80 (72–88) | 19 (11–27) | 54 (44–63) | |||
| Individual Randomization: Blood Clot |
83 (79–86) | 0.22 | 58 (54–63) | <0.001 | 51 (47–56) | 0.92 |
| GN | 78 (68–87) | 61 (50–72) | 49 (38–60) | |||
| O | 86 (79–93) | 72 (64–81) | 53 (43–62) | |||
| O + I | 84 (75–93) | 67 (56–78) | 56 (44–67) | |||
| WC(C) | 87 (81–94) | 48 (39–58) | 51 (41–60) | |||
| WC(I) | 76 (66–86) | 39 (28–51) | 49 (37–61) | |||
| Individual Randomization: UTI |
82 (78–85) | 0.03 | 57 (52–61) | 0.03 | 59 (54–64) | 0.49 |
| GN | 74 (65–83) | 64 (54–74) | 53 (43–63) | |||
| O | 76 (67–85) | 54 (44–65) | 59 (49–69) | |||
| O + I | 87 (80–95) | 67 (56–77) | 65 (55–76) | |||
| WC(C) | 88 (81–95) | 43 (32–55) | 55 (44–66) | |||
| WC(I) | 86 (79–94) | 54 (43–65) | 63 (52–73) | |||
| Cluster Randomization: Surgical Rods |
82 (79–85) | 0.21 | 46 (42–50) | 0.13 | 60 (55–65) | 0.32 |
| GN | 85 (80–90) | 51 (45–58) | 62 (56–69) | |||
| NO/POST | 80 (75–86) | 42 (35–49) | ||||
| OPT-Out | 79 (73–85) | 45 (38–52) | 58 (51–64) | |||
| Cluster Randomization: Needles |
78 (75–81) | 0.99 | 55 (51–59) | 0.27 | 72 (68–76) | 0.73 |
| GN | 78 (72–84) | 59 (53–66) | 71 (65–77) | |||
| NO/POST | 78 (72–83) | 54 (48–61) | ||||
| OPT-Out | 78 (73–84) | 52 (45–58) | 73 (67–78) | |||
POST, post-study notification; GN, general notification; GN-OO, general notification with the option to exclude their medical records from the study; O, oral consent; O+I, oral consent and a 1-page study information sheet; WC (MR), written consent for medical record review; WC (I), written consent detailing the incremental risks; WC (C), written consent detailing incremental and clinical risks. See Appendix A for more information.
“In this imaginary research study, are both of the [medicines/needles/rods] commonly used to treat [specify condition]?” (Responses: Yes, No)
“If you were a participant in the research study, how would your [medicine/needle/rod] be chosen?” [Responses: Doctor chooses, Doctor and I choose together, Randomly (like flipping a coin), Unsure]
“Besides being examined by the doctor, undergoing any tests necessary for your clinical care, having the study explained to you, receiving an information sheet, and following your prescribed treatment plan, do you recall any extra things you would have to do as part of the study?” (Responses: Yes, No, Unsure)
Chi-square P value testing the null hypothesis that the number of correct understanding responses is the same for every method of notification and authorization within scenario.