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

Myers 2011.

Methods Study design: patient‐randomized trial
Unit of allocation: patient
Unit of analysis: patient
Power calculation: unclear
Participants Setting of care: primary care, ambulatory care, USA
Healthcare professionals: 22 physicians; fully trained (board certified practitioners)
Patients: 313; eligible for prostate cancer screening; males
Interventions Multifaceted intervention: Including patient‐mediated interventions (pamphlet and counseling) and reminders (prompting)
Quote: "... mailed a12‐page information brochure on prostate cancer and screening to all participants." page 241
"The nurse educators met EI Group men at the office visit, reviewed the content of the mailed booklet, and conducted a structured decision counselling session about prostate cancer. [The nurses] elicited factors that were likely to influence the participant's screening decision, align with their relative influence and strength. Then nurse educator then used a hand‐held computer with a pre‐programmed algorithm to compute each participants's decision preference score ..." page 241
"... the nurse educator also placed a generic note on each EI group participant's medical chart to prompt the physician to discuss prostate cancer screening." page 241
Multifaceted intervention: Including patient‐mediated interventions and reminders (prompting) (control). The brochure and the prompt were the same as those in the intervention group.
Outcomes Informed decision‐making scale; SDM is assessed as the fostering by healthcare professionals of active participation of patients in the decision‐making process.
Notes Additional information
Number of approached patients (eligible): 1245
Number of patients per physician: median number of patients per physician is 8.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Using a system of sealed envelopes, the nurse educator then determined the participants's study group assignment to either …" page 241
Allocation concealment (selection bias) Low risk Quote: "Using a system of sealed envelopes, the nurse educator then determined the participants's study group assignment to either …" page 241
Blinding (performance bias and detection bias) 
 Observer‐based outcome Unclear risk Comment: not specified in the paper.
Incomplete outcome data (attrition bias) 
 Observer‐based outcome Unclear risk Comment: for the entire study, there was an over 90% follow‐up, however, only 50% audio‐recorded encounters (46% in SI group, 55% in EI group); 84% of the audio.
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? 
 Observer‐based outcome Unclear risk Comment: not specified in the paper.
Protection against contamination? High risk Quote: "Certain patients in either the groups received their unassigned interventions." page 242
Baseline characteristics patients Low risk Comment: "The data show that the two groups were well balanced on all the measured variables." page 242 (table 2)
Baseline characteristics healthcare professionals Unclear risk Comment: no report of characteristics.