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. |