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. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

van Tol‐Geerdink 2016.

Methods Study design: randomized trial
Unit of allocation: patient
Unit of analysis: patient
Power calculation: not done
Participants Care setting: ambulatory care, specialized care, the Netherlands
Health professionals: specialists; fully trained
Patients: 240; prostate cancer; male
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)
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.