Legare 2012.
| Methods | Cluster‐randomized controlled trial to decision aid vs usual care | |
| Participants | 239+210 adults and children with with a diagnosis of acute respiratory infection (e.g., bronchitis, otitis media, pharyngitis, rhinosinusitis) | |
| Interventions | DA (in consultation): pamphlet on options' outcomes, clinical problem, outcome probabilities, explicit values clarification, guidance and coaching (participating physicians also received training in the form of a 2‐hour online tutorial and a 2‐hour on‐site interactive workshop). Comparator: usual care |
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| Outcomes | Primary outcome: use of antibiotics (immediately post consultation) Secondary outcomes: decisional conflict (immediately post), control preference scale (immediately post), quality of decision (immediately post), adherence to the decision (2 weeks post), repeat consultation (2 weeks post), decisional regret (2 weeks post), quality of life (2 weeks post) and intention to engage in SDM in future consultations regarding antibiotics for acute respiratory infections (2 weeks post) |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A biostatistician used internet‐based software to simultaneously randomize all 12 family practice teaching units to either the intervention group or control group. The teaching units were stratified according to rural or urban location" (p E728) |
| Allocation concealment (selection bias) | Low risk | "A biostatistician used internet‐based software to simultaneously randomize all 12 family practice teaching units to either the intervention group or control group. The teaching units were stratified according to rural or urban location" (p E728) |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Patients with symptoms suggestive of an acute respiratory infection were initially recruited by a RA in the waiting room before consultation with a physician" (p E728) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The biostatistician was unaware of group allocation, the researchers and research assistants who recruited patients and collected data were not" and "Statistical analysis was performed by a statistician who was unaware of the teaching unit allocations" (p E729) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
| Selective reporting (reporting bias) | Low risk | Protocol registered and published |
| Other bias | Low risk | "To avoid contamination bias, access to the online tutorial was denied to providers in the control group during the trial" (p E728) |