Deen 2012.
Methods |
Study design: patient‐randomized trial Unit of allocation: patient Unit of analysis: patient Power calculation: done |
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Participants |
Care setting: primary care; specialized care and ambulatory care (health center); USA Health professionals: not mentioned in paper Patients: 279; no one particular type of clinical condition; 103 males and 176 females |
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Interventions |
Four arms:
Quote: "Individuals agreeing to participate provided informed consent and were then randomly assigned to one of 4 groups: no intervention (control = data collection and doctor visit), pre‐visit exposure to a PAI, pre‐visit exposure to the DA, and pre‐visit exposure to both DA and the intervention (DA + PAI). The DA selected for this project, ..., to impart general information to patients about their role in gaining information and care within a medical setting." page 179 |
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Outcomes | Patient Activation Measure (PAM); the fostering by healthcare professional of active participating of patients in the decision‐making process. | |
Notes |
Additional information Number of approached patients (eligible): 945 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 | Quote: "Individuals agreeing to participate provided informed consent and were then randomly assigned to one of 4 groups." page 179 |
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: no information about the number of participants excluded in the analysis in the study arms. Exclusion of participants after the randomization may not preserve the benefit of randomization. |
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 | Quote: "Pre and post‐visit data were collected in the CHC waiting room prior to and following a physician visit" |
Protection against contamination? | High risk | Comment: It was the patients who were randomised |
Baseline characteristics patients | High risk | Comment: gender and race/ethinicty were not evenly distributed across the study arms (page 182). Moreover, PAM scores were associated with ethnicity (table 1). Analysis did not adjust for these variables. |
Baseline characteristics healthcare professionals | Unclear risk | Comment: No report of characteristics |