Frosch 2008a.
| Methods | Randomized to decision aid vs. decision aid + chronic disease trajectory vs chronic disease trajectory vs usual care (Internet information) | |
| Participants | 155 + 152 + 153 + 151 men considering prostate cancer screening | |
| Interventions | DA: information on options' outcomes, clinical problem, outcome probabilities, others' opinions Comparator 1: information on options' outcomes, clinical problem, outcome probabilities, others' opinions, explicit values clarification (utilities for outcomes associated with prostate cancer) Comparator 2: explicit values clarification (utilities for outcomes associated with prostate cancer) Comparator 3: usual care using public information on prostate cancer screening on American Cancer Society and Centers for Disease Control and Prevention websites 2005‐2006 |
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| Outcomes | Primary outcomes: knowledge, actual option, decisional conflict Secondary outcomes: concern about prostate cancer, treatment preference if prostate cancer diagnosed |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer algorithm randomly assigned participants to the 4 study groups |
| Allocation concealment (selection bias) | Low risk | Revealed after signed consent and completed baseline measures |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Accessed a secure Internet site that hosted all study materials; participants had unlimited access to assigned intervention, unclear blinding of personnel |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Unclear blinding but outcomes were measured via questionnaires and not subjective to interpretation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Used intention‐to‐treat analysis; imputed missing data for participants who did not complete follow‐up assessments; minimal attrition |
| Selective reporting (reporting bias) | Unclear risk | No indication of published protocol |
| Other bias | Low risk | Appears to be free of other potential biases |