Davison 1997.
Methods |
Study design: patient‐randomized trial Unit of allocation: patient Unit of analysis: patient Power calculation: not clear |
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Participants |
Care setting: specialized care and ambulatory care (Winnipeg Community Clinic); Canada
Health professionals: 2; urologist; fully trained Patients: 60; prostate cancer; men |
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Interventions |
Single intervention; patient‐mediated intervention (individual empowerment sessions) This session helped them to think on how to discuss with the doctor what treatment is best for them and what questions to ask the physician. Single intervention (control); patient‐mediated intervention (information package) A list of questions, also found in the empowerment session. |
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Outcomes | Perceived level of control in the decision‐making process (categorical); joint process between healthcare professionals and patients to make decisions | |
Notes |
Additional information Number of approached patients (eligible): 60 Number of patients per physician: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The group to which subjects were assigned was predetermined by a block randomization procedure" n.p. |
Allocation concealment (selection bias) | Unclear risk | Comment: not specified in the paper. |
Blinding (performance bias and detection bias) Participant‐reported outcome | Unclear risk | Comment: not specified in the paper. |
Incomplete outcome data (attrition bias) Participant‐reported outcome | Low risk | Comment: for our primary outcome (n = 60). |
Selective reporting (reporting bias) | Unclear risk | Comment: no evidence that outcomes were selectively reported, but no protocol. |
Other bias | Low risk | Comment: no evidence of other risk of biases. |
Baseline measurement? Participant‐reported outcome | Low risk | Quote: "At the pre‐test, no significant differences were found between the role preference of the groups (Chi2 = 4.365, P = 0.113)." page 194 |
Protection against contamination? | High risk | Comment: it was the patients who were randomized in one community clinic. |
Baseline characteristics patients | Low risk | Quote: "The two groups were not significantly different from one another with reference to: age category, years of education, education category, marital status, residence, days from first interview, and intended/received treatment" n.p. |
Baseline characteristics healthcare professionals | Unclear risk | Comment: no report of characteristics. |