Man‐Son‐Hing 1999.
Methods | Randomized to decision aid vs usual care | |
Participants | 139 + 148 patients on atrial fibrillation trial considering continuing on aspirin vs change to Warfarin in Canada | |
Interventions | DA: audiotape booklet on options' outcomes, clinical problem, outcome probability, explicit values clarification, others' opinions, guidance (Ottawa Decision Support Framework) Comparator: usual care | |
Outcomes | Primary outcomes: uptake of options, adherence Secondary outcomes: help with making a decision, knowledge, accurate risk perceptions, decisional conflict, satisfaction with decision making process, role in decision making |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated scheme (p 2) |
Allocation concealment (selection bias) | Low risk | Administered from a central location (p 2) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unclear blinding however, "contamination, physicians may have provided DA information to patients receiving usual care" (p 7) |
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 | Unclear risk | P 4, fig 2 flow chart. Reasons for attrition not mentioned. Baseline data not included. |
Selective reporting (reporting bias) | Unclear risk | No information provided |
Other bias | Low risk | No other potential risks of bias |