Nassar 2007.
Methods | Randomized to decision aid vs usual care | |
Participants | 102 + 98 women diagnosed with a breech presentation from 34 weeks gestation considering external cephalic version in Australia | |
Interventions | DA: 24‐page booklet, 30‐minute audio‐CD and worksheet; clinical problem, outcome probability, explicit values clarification, opinions of others', guidance (Ottawa Decision Support Framework) Comparator: usual care counselling and information on the management of breech presentation |
|
Outcomes | Primary outcomes: knowledge, decisional conflict, anxiety, satisfaction with the decision, Secondary outcomes: preferred role in decision making, preferred choice |
|
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "[R]andomly generated using computer and stratified by parity and center using random variable block sizes" (p 2) |
Allocation concealment (selection bias) | Low risk | "[P]articipants were randomized by telephoning a remote, central location" (p 2) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Womens were not blinded ‐ unclear if this would introduce bias to outcome assessed |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Unclear blinding but outcomes were objectively measured and not subjective to interpretation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up because of onset of labour or incomplete data forms (p 3). Baseline characteristics are included and equal. Minimum of 84 participants in each study group achieved; p 4 ‐ flow diagram |
Selective reporting (reporting bias) | Low risk | ISRCTN14570598 |
Other bias | Low risk | "Maternal characteristics and baseline measures of cognitive and affective outcomes were comparable between groups" (p 3 Results, Table 1) "Blinding clinicians and employment of a research midwife to interact with women" (p 6) |