Leighl 2011.
Methods |
Study design: patient‐randomized trial Unit of allocation: patient Unit of analysis: patient Power calculation: done |
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Participants |
Care setting: specialized care,aAmbulatory care; Australia, Canada Health professionals: 13 oncologists; fully trained Patients: 207, advanced colorectal cancer; male and female: 120 males, 87 females |
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Interventions |
Multifaceted intervention: Patient‐mediated intervention (decision aid), physician training (educational meeting) Decision aid: booklet with accompanying narration on an audiotape or CD Quote: "The DA used in this study was developed as a booklet with accompanying narration on an audiotape or compact disc for patients to take home ... Oncologists were trained to use the DA during the consultation and instructed to have patients return after the initial consultation for a final treatment decision as part of the study." page 2079 No intervention, (control): standard consultation |
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Outcomes | Modified Control Preferences Scale. Joint process between healthcare professionals and patients to make decisions | |
Notes |
Additional information Number of approached patients (eligible): 229 Number of patients per physician: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization lists, stratified by the consulting oncologists, were computer‐generated…" page 2078 |
Allocation concealment (selection bias) | Low risk | Quote: "…and the code was concealed in a sealed envelope until the time of random assignment." page 2078 |
Blinding (performance bias and detection bias) Participant‐reported outcome | Unclear risk | Comment: not specified in the paper. |
Incomplete outcome data (attrition bias) Participant‐reported outcome | Unclear risk | Comment: losses to follow‐up were balanced in number and percentage across group (overall) but reasons for lost to follow‐up were not reported. Missing data related to our primary outcome are not reported. |
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? Participant‐reported outcome | Low risk | Comment: see table 1 for measurement prior to consultation, page 2078 |
Protection against contamination? | Low risk | Quote: "Those receiving the DA were counselled not to share it with others in the waiting room to avoid contamination of the standard arm. To further minimize contamination between the arms, five consultations were audiotaped before study commencement as a baseline for comparison with consultations in the standard arm." page 2078 |
Baseline characteristics patients | Unclear risk | Comment: "Patient characteristics were well balanced between the groups (Table 2), although more patients randomly assigned to receive the DA reported English as their first language." page 2080. Comment: language may be related to some outcomes namely patient understanding and decision involvement but the authors did not specified if they adjusted that variable in the multivariate analysis. |
Baseline characteristics healthcare professionals | Unclear risk | Comment: no report of characteristics. |