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. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

Deen 2012.

Methods Study design: patient‐randomized trial
Unit of allocation: patient
Unit of analysis: patient
Power calculation: done
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
Interventions Four arms:
  • Pptient‐mediated intervention (decision aid (DA) and patient activation (PA))

  • patient‐mediated intervention ( PA)

  • patient‐mediated intervention (DA)

  • control (doctor visit)


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
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
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