Table 1.
SAM+CAM and SMOG scores for informed consent materials by type of form
| SAM+CAM Scores a |
Mean SAM+CAM Score (SD) |
SMOG Readability Score (SD) |
|||
|---|---|---|---|---|---|
| Type of Material | N (%) |
Adequate N (%) |
Superior N (%) |
||
|
Adult Participant Consent Forms | |||||
| Multiple consent b | 9 (9) | 0 | 9 (100) | 80 (6) | 12 (2) |
| Intervention c | 22 (23) | 3 (14) | 19 (86) | 80 (8) | 12 (2) |
| Survey | 3 (3) | 0 | 3 (100) | 74 (3) | 12 (0.6) |
| Interview | 4 (4) | 0 | 4 (100) | 78 (7) | 10 (2) |
| Focus group | 5 (5) | 0 | 5 (100) | 75 (4) | 12 (1) |
| Audio-recording of clinic visit | 1 (1) | 1 (100) | 0 | 40 | 16 |
| Biospecimen | 2 (2) | 1 (50) | 1 (50) | 74 (8) | 13 (2) |
| Innovative method | 3 (3) | 1 (33) | 2 (67) | 75 (5) | 12 (1) |
| Subtotal | 49 (50) | 6 (12) | 43 (88) | 78 (9) | 12 (2) |
|
Adult Participant Assent Forms | |||||
| Survey | 1 (1) | 1 (100) | 0 | 68 | 12 |
| Interview (community leader) | 1 (1) | 1 (100) | 0 | 59 | 13 |
| Focus group | 1 (1) | 1 (100) | 0 | 68 | 13 |
| Multiple assent b | 4 (4) | 0 | 4 (100) | 76 (2) | 12 (0.5) |
| Intervention | 2 (2) | 2 (100) | 0 | 55 (0.3) | 14 (3) |
| Subtotal | 9 (9) | 5 (56) | 4 (44) | 68 (9) | 13 (1) |
|
Staff or Provider Consent Forms | |||||
| Survey | 1 (1) | 1 (100) | 0 | 68 | 10 |
| Interview | 4 (4) | 1 (25) | 3 (75) | 74 (6) | 11 (2) |
| Focus group | 1 (1) | 1 (100) | 0 | 68 | 11 |
| Intervention | 1 (1) | 0 | 1 (100) | 73 | 11 |
| Audio-recording of clinic visit | 2 (2) | 1 (50) | 1 (50) | 71 (3) | 12 (1) |
| Subtotal | 9 (9) | 4 (44) | 5 (56) | 72 (4) | 11 (2) |
|
Staff or Provider Assent Forms | |||||
| Survey | 4 (4) | 1 (25) | 3 (75) | 75 (5) | 12 (0.5) |
| Interview | 1 (1) | 0 | 1 (100) | 73 | 12 |
| Subtotal | 5 (5) | 1 (20) | 4 (80) | 75 (4) | 12 (2) |
| Child Assent | |||||
| Focus group | 2 (2) | 1 (50) | 1 (50) | 71 (10) | 11 (3) |
| Intervention | 3 (3) | 3 (100) | 0 | 67 (3) | 10 (0.6) |
| Subtotal | 5 (5) | 4 (80) | 1 (20) | 68 (6) | 10 (2) |
| Addenda d | |||||
| 20 (21) | 17 (85) | 3 (15) | 61 (11) | 13 (2) | |
| Total | 97 (100) | 37 (38) | 60 (62) | 72 (11) | 12 (2) |
Abbreviations: SAM+CAM = the Suitability and Comprehensibility Assessment of Materials, SD = standard deviation, SMOG = Simple Measure of Gobbledygook
Notes:
The SAM+CAM percentage scores were calculated by dividing the sum of ratings by the total possible ratings, and are grouped as follows: 0–39% = not suitable; 40–69% = adequate; and 70–100% = superior. “Not suitable” means not suitable for an audience with low health literacy. None of the materials we reviewed received a SAM+CAM score of “not suitable.”
These forms asked people to consent to more than one study procedure: for example, an interview, a survey, and access to medical records.
Intervention studies typically included an educational session and some other variable (such as a special diet for participants) manipulated by the investigators. These studies often required multiple procedures, such as a survey, an interview, and a blood draw. The consent forms often mentioned randomization.
These included HIPAA forms, flyers, brochures, and other materials used to enhance the consent process.