van Tol‐Geerdink 2016.
Methods |
Study design: randomized trial Unit of allocation: patient Unit of analysis: patient Power calculation: not done |
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Participants |
Care setting: ambulatory care, specialized care, the Netherlands Health professionals: specialists; fully trained Patients: 240; prostate cancer; male |
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Interventions |
Single intervention: patient‐mediated intervention (decision aid) Quote: ''The decision aid explained that there are different treatment options with different pros and cons. Radial protatectomy and external beam radiotherapy were presented to all patients. A third option, bradytherapy was presented only to eligible patients.'' page 463 Usual care (control) |
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Outcomes | Patient participation (qualitative) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: no information about sequence generation. |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was centralized to avoid allocation bias and was blocked in groups of 3 per hospital, thus stratifying for hospital site." page 461 |
Blinding (performance bias and detection bias) Participant‐reported outcome | High risk | Quote: "Patients and caregivers could not be blinded to the intervention." page 460 |
Incomplete outcome data (attrition bias) Participant‐reported outcome | High risk | Comment: there are losses to follow‐up after randomization and missing data and reasons were not well‐balanced (flow chart of the study). |
Selective reporting (reporting bias) | Unclear risk | Comment: no information about registration of the protocol. |
Other bias | Low risk | |
Baseline measurement? Participant‐reported outcome | Unclear risk | Comment: no outcome measure at baseline. |
Protection against contamination? | High risk | Comment: randomization was done at the patient level. |
Baseline characteristics patients | Low risk | Quote: "Patient characteristics in the decision aid group and the usual care group were comparable for education, age, baseline physical functioning and tumour characteristics." page 465 |
Baseline characteristics healthcare professionals | Unclear risk | Comment: no information about clinicians at baseline. |