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. 2017 Apr 12;2017(4):CD001431. doi: 10.1002/14651858.CD001431.pub5

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
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)
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