Kuppermann 2014.
Methods | Randomized to decision aid vs usual care | |
Participants | 375 + 369 11‐week pregnant women who had not yet undergone prenatal screening or diagnostic testing | |
Interventions | DA: describes clinical condition, options, outcome probabilities, values clarification Comparator: usual care |
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Outcomes | Primary outcomes: invasive prenatal diagnostic testing (3 to 6 months) Secondary outcomes: testing strategy undergone (3 to 6 months), knowledge (3 to 6 months), accurate risk perception (procedure related miscarriage, DS affected fetus) (3 to 6 months), decisional conflict (3 to 6 months), decisional regret (3 to 6 months) |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A computer generated random allocation sequence assigned participants to experimental groups within permuted blocks of random size, with a 1:1 allocation ratio, stratified by age, clinical site, parity, and interviewer" (p 1211) |
Allocation concealment (selection bias) | Low risk | "The randomization code was not available to any study‐related personnel until data analysis was complete" (p 1211) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Different research associates facilitated baseline and follow‐up interviews and medical record review to ensure blinding to the randomization assignment" (p 1211) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Different research associates facilitated baseline and follow‐up interviews and medical record review to ensure blinding to the randomization assignment" (p 1211) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar attrition in both groups. "[A]ll reported analyses were based on a modified intention‐to‐treat sample" (p 1211) |
Selective reporting (reporting bias) | Low risk | Trial registered |
Other bias | Low risk | Appears to be free of other sources of bias |