Auvinen 2004.
| Methods | Randomized to decision aid vs usual care | |
| Participants | 103 + 100 men newly diagnosed with prostate cancer in Finland | |
| Interventions | DA: pamphlet patient decision aid created for study on options' outcomes, outcome probability, guidance Comparator: usual care by clinical guideline | |
| Outcomes | Primary outcome: uptake of options Secondary outcome: participation in decision making Other outcomes (from Huang 2014): death (5 years), disease‐free survival (10‐years), biochemical failure (serum PSA elevation) (5 years), biochemical failure‐free survival (5 years), disease progression (5 years), disease progression‐free survival (5 years) (data from 104 + 106 men) |
|
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Auvinen 2001, p 2: "randomized centrally, using software based on a random number generator"; no blocking used Auvinen 2004, (primary study), p 1: "randomized using a computer algorithm based on random numbers" |
| Allocation concealment (selection bias) | Unclear risk | Auvinen 2001,p 2, Patients and Methods: randomized centrally at the Finnish Cancer Registry Auvinen 2004, (primary study), p 1: randomized centrally Comment: central allocation confers low risk |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Auvinen 2001, p 3: "recognized carry‐over effect because same physician in charge for intervention and control groups, diminish contrast between groups, as these physicians were more motivated to inform patients than those physicians not participating" Auvinen 2004 (primary study): no blinding but primary outcome is choice of treatment for prostate, objectively recorded. But unsure how physicians may have influenced decisions |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | No blinding but primary outcome is choice of treatment for prostate, objectively recorded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Auvinen 2001, p 3: flow‐chart "Imbalance in the numbers of patients between the arms within two hospitals. Not expected to affect the results in any way"; "some participants refused to give informed consent, health deterioration, not seen by urologist" (p 4) Auvinen 2004 (primary study), p 2: flow diagram and results; low attrition and consistent between groups |
| Selective reporting (reporting bias) | Unclear risk | No indication that trial registered in central trials registry. Auvinen 2001, p 2: "The study protocol was approved by an ethical committee in each participating hospital" Auvinen 2004 (primary study), p 1: "The study protocol was approved by the institutional review board at each participating hospital" |
| Other bias | Low risk | Appears to be free of other potential biases |