Bozic 2013.
Study characteristics | ||
Methods | RCT | |
Participants | 95 (coaching + decision aid) versus 103 (usual care) patients with a primary diagnosis of osteoarthritis of the hip or knee seeing an orthopaedic surgeon for the first time for this problem, and no history of a lower‐extremity joint arthroplasty and considered medically appropriate for total joint arthroplasty | |
Interventions | Intervention: Shared decision making intervention. decision aid (DVD, booklet), communication aid, question listing with coach, taped consultation, surgeon's dictated note Comparator: Usual care. Map, directions, one‐page info on signs and symptoms, diagnosis and treatment options for hip and knee osteoarthritis |
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Outcomes | Primary: Informed decision (knowledge) Secondary: Treatment choice (uptake), patient and provider satisfaction with the process of using shared decision making tools, length of consultation time |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “The randomization was blocked with use of random permuted blocks in groups of four, six, or eight to help ensure that the groups were balanced” (p. 1634). |
Allocation concealment (selection bias) | Low risk | “Patients were randomized to either the intervention group or the control group with use of the sealed envelop method” (p. 1634). |
Blinding of participants and personnel (performance bias) ‐ Study Level | Unclear risk | “[S]urgeons were not blinded to the intervention” (p. 1635). Knowing the allocation could be due to greater investment in decision‐making. Insufficient information to make a judgement |
Blinding of outcome assessment (detection bias) ‐ Study Level | Low risk | Outcomes were objectivelymeasured and not subject to interpretation. |
Incomplete outcome data (attrition bias) ‐ Study level | Unclear risk | 62% (123/198) retention rate, therefore, high attrition rate ‐ however the attrition was balanced between groups. |
Selective reporting (reporting bias) | Low risk | Protocol available |
Other bias | Low risk | Appeared to be free of other sources of bias |