Mishel 2009.
Study characteristics | ||
Methods | RCT | |
Participants | 93 (coaching + written information + video) + 74 (control) men with prostate cancer staging (T1a, b, c or T2a, b), Gleason score less than 10, prostate‐specific antigen level less than 20, at least 10 days before the treatment consultation appointment. There was a second intervention group with 89 + a support person receiving the same intervention (results not reported in this review). | |
Interventions | Intervention: booklet on prostate cancer "Treatment Choices for Early Stage Prostate Cancer: Patients' Questions ‐ Doctors' Answers" from members of the Radiation Oncology Research Unit in Canada (before it was changed to be a patient decision aid), digital video disc presenting communication strategies, 4 decision‐coaching telephone calls by trained nurse Control: handout on staying healthy during treatment |
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Outcomes | Primary: uncertainty management: problem‐solving subscale, patient‐provider communication subscale, prostate cancer knowledge scale Secondary: patients' perception of self‐communication, types of information used and its helpfulness, decisional regret, mood disturbances, quality of life |
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Notes | No patients were partners on the research team; trial registration not reported; funded by the NIH NINR; research ethics approval obtained; no reported conflicts of interest | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The design for the study was a 3 x 2 randomized block, repeated measures design with three levels of the intervention: (treatment direct, treatment supplemented and control) and two levels of ethnicity (Caucasian and African‐American). Patients were randomly assigned to one of the treatment groups or to the control groups." No further information provided |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) ‐ Study Level | Unclear risk | No information provided |
Blinding of outcome assessment (detection bias) ‐ Study Level | Unclear risk | No information provided |
Incomplete outcome data (attrition bias) ‐ Study level | Unclear risk | Numbers analysed or lost to follow‐up after baseline not reported. No information provided, no flow chart |
Selective reporting (reporting bias) | Unclear risk | No information about study registration or protocol publication given |
Other bias | Low risk | Appeared to be free from other potential bias |