Street 1995.
Methods |
Study design: patient‐randomized trial Unit of allocation: patient Unit of analysis: patient Power calculation: not done |
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Participants |
Care setting: specialized care and ambulatory care (Scott and White clinic and Hospital (Texas)); USA Health professionals: 10; various type of physician (4 medical oncologists, 2 radiation oncologists, 4 surgeons); fully trained Patients; 60; breast cancer; female |
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Interventions |
Single‐intervention: patient‐mediated intervention (Interactive multimedia program (decision aid));15‐20 minutes. Quote: "The program "Options for treating breast cancer" is an interactive program using a touch‐screen monitor containing audio‐visual elements. It provides an introductions, elaborate the problem, treatment options and provides testimonies of other women's experiences." page 2277 Single‐intervention (control): patient‐mediated intervention (brochure (decision aid)) Quote: "This is an eight page brochure entitled "Care of patients with early breast cancer". It contains comments by other women, elaborates the problem and presents treatment options. The medical information is the same in both the multimedia format and the brochure format." page 2278 |
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Outcomes | Perceived decision control (continuous); joint process between healthcare professionals and patients to make decisions. | |
Notes |
Additional information Number of approached patients (eligible): not reported 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) | Unclear risk | Comment: patients were randomized but the method was unspecified. |
Allocation concealment (selection bias) | Unclear risk | Comment: not specified in the paper. |
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: not specified in the paper. |
Selective reporting (reporting bias) | High risk | Comment: patient participation in the consultations was not reported in each study group but according to age and education (contrary to the hypotheses 2). Thus, we are not able to see if patient using the computer program will be more involved in the DM than will patients reading the brochure. |
Other bias | Low risk | Comment: no evidence of other risk of biases |
Baseline measurement? Participant‐reported outcome | Unclear risk | Comment: not specified in the paper. |
Protection against contamination? | High risk | Comment: outcome is patient reported and the intervention is patient allocated. Consequently patients could discuss the intervention among themselves. |
Baseline characteristics patients | Low risk | Quote: "… there were no significant differences between the multimedia or brochure group with respect to the patient's age, education, disease stage, or ethnicity." page 2277 |
Baseline characteristics healthcare professionals | Unclear risk | Comment: no report of characteristics. |