Table 2 Results of trials with enhanced consent form intervensions
Standard control | Sample size | Understanding scores, % | ||||||
|---|---|---|---|---|---|---|---|---|
Source | Intervention | Population | Scenario | Control | Intervention | P Value | ||
Paris et al., 2010 | Y | Simplified paper document with systematic readability improvement | Patients with stroke, DM, or OSAS | Simulated | 115 | 67 | 69 | NS |
Y | Simplified paper document developed by a working group of clinical research nurse, IRB member, and healthy volunteer | Patients with stroke, DM, or OSAS | Simulated | 114 | 67 | 69 | NS | |
Campbell et al., 2008 | N | Simplified text in booklet format with color. 7th grade reading level | Healthy volunteers | Simulated | 146 | 64 | 85 | <0.001 |
Walters and Hamrell, 2008 | Y | Simplified paper document. 6th grade reading level | Healthy volunteers | Simulated | 317 | 77 | 79 | NS* |
Paris et al., 2007 | Y | Simplified paper document with systematic readability improvement | Healthy volunteers | Simulated | 99 | 78 | 82 | ≤0.05 |
Y | Simplified paper document developed by a working group of clinical research nurse, IRB member, and healthy volunteer | Healthy volunteers | Simulated | 101 | 78 | 83 | ≤0.017 | |
Y | Simplified paper document developed by a working group and by systematic readability improvement | Healthy volunteers | Simulated | 100 | 78 | 82 | ≤0.05 | |
Campbell et al., 2004 | Y | Simplified paper document with revised layout, text styling, and added pictures | Parents of pediatric patients | Simulated | 119 | 47 | 53 | NS |
Agre and Rapkin, 2003 | N | Simplified paper document presented in booklet form with summary section. 8th grade reading level | Patients with cancer and healthy volunteers | Real | 221 | 69 | 70 | NS |
Coyne et al., 2003 | Y° | Simplified paper document with revised text styling, page layout, and language. 7th grade reading level. Organized in Q/A format° | Patients with cancer | Real | 207 | 69 | 72 | NS‡ |
Dresden and Levitt, 2001 | N | Simplified paper document with revised layout, text styling, and language | Patients in the E.R. | Simulated | 100 | 72 | 88 | <0.0001 |
Stiles et al., 2001 | Y° | Simplified paper document with text styling and graphics° | Patients with mental illness and healthy volunteers | Simulated | 227 | 81 | 81 | NS |
Bjorn et al., 1999 | N | Leaflet used by pharmacology company with revised language, style and layout. Hypertension scenario | Healthy volunteers | Simulated | 135 | 48 | 56 | <.05 |
N | Leaflet used by pharmacology company with revised language, style and layout. Sterilization scenario | Healthy volunteers | Simulated | 100 | NA | NA | NS | |
Murphy et al., 1999 | N | Simplified paper document. 6th grade reading level with text styling and illustrations | Women at risk for HIV | Simulated | 141 | 70 | 83 | 0.0001 |
Davis et al., 1998 | Y | Revised with patient input, readability improved from college to 7th grade level, shortened, booklet format, graphics | Patients and healthy volunteers | Simulated | 183 | 56 | 58 | NS |
Rogers et al., 1998 | Y° | Consent required to “opt out” of study, rather than “opt in”° | Recent mothers | Real | 44 | 30 | 47 | <0.02 |
Taub et al., 1987 | Y | Simplified paper document. 7th grade reading level | Elderly volunteers | Real | 235 | 68 | 70 | NS |
N | Standard or simplified paper document with “Letter Gothic”, enlarged font | Elderly volunteers | Real | 235 | 71 | 65 | NS* | |
N | Standard or simplified paper document with “Orator”, enlarged all-caps font | Elderly volunteers | Real | 235 | 71 | 70 | NS | |
Taub et al., 1986 | Y | Simplified paper document. 7th grade reading level | Patients with heart disease | Real | 188 | 71 | 74 | NS |
Epstein and Lasagna, 1969 | Y | Simplified paper document. Shorter with succinct phrasing | Hospital Employees | Simulated | 44 | 45 | 67 | <.001 |