Thomson 2007.
Methods | Randomized to decision aid vs usual care by clinical guidelines | |
Participants | 69 + 67 patients with atrial fibrillation considering treatment options in the UK | |
Interventions | DA (in consultation): computerized decision on options' outcomes, clinical problem, outcome probabilities, explicit values clarification, guidance/coaching by physician Comparator: guidelines applied as direct advice |
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Outcomes | Primary outcome: decisional conflict Secondary outcomes: anxiety, knowledge, resource use, choice, health outcomes (stroke, transient ischaemic attack, bleeding events) |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "[E]lectronically‐generated random permuted blocks via a web‐based randomisation service" (p 2, Recruitment and randomization) |
Allocation concealment (selection bias) | Low risk | "[E]lectronically‐generated random permuted blocks via a web‐based randomisation service" (p 2, Recruitment and randomization) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Physicians were blinded. Unclear if patients are blinded and how that may affect the outcome |
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 | See flow diagram |
Selective reporting (reporting bias) | Low risk | ISRCTN24808514 |
Other bias | Low risk | Baseline characteristics similar, sample size similar, not stopped early |