| Methods |
Study design: cluster‐randomized trial
Unit of allocation: practice
Unit of analysis: provider and patient
Power calculation: done |
| Participants |
Care setting: primary care and ambulatory care, USA
Health professionals: 117, various types (physician, nurse practitioner, physician assistant (see study protocol page 3)); fully trained and in training
Patients: 301; depression; male and female |
| Interventions |
Single intervention: patient‐mediated intervention
Quote: "Clinicians in the intervention group were to use the decision aid during the consultation with their patients..." page 1764
Usual care (control):
Quote: "...whereas clinicians in the control arm did not have access to the decision aid (usual care)." page 1764 |
| Outcomes |
OPTION (continuous) |
| Notes |
Additional information
Number of approached practices (eligible): not reported
Number of patients per physician: 2, number of patients per practice: 34; number of clinician per practice: 7 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Comment: insufficient information to make a judgement. |
| Allocation concealment (selection bias) |
Low risk |
Quote: "The lead study statistician therefore stratified practices by their history of accrual and the presence of the DIAMOND [Depression Improvement Across Minnesota ‐ Offering New Direction]
program (a practice redesign initiative to improve depression care present in numerous Minnesota practices at the time of the study), and centrally randomized practices within these strata to either care with or without Depression Medication Choice." page 1763 |
| Blinding (performance bias and detection bias)
Observer‐based outcome |
High risk |
Quote: "Study team members, practices, and clinicians were aware of the assigned arms." page 8 |
| Incomplete outcome data (attrition bias)
Observer‐based outcome |
Low risk |
Comment: "There was no difference in the attrition of participants or completeness of the data across arms (Figure 2)." page 11 |
| Selective reporting (reporting bias) |
Low risk |
Comment: The study protocol is available and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way. |
| Other bias |
Low risk |
Comment: No evidence of other risk of biases. |
| Baseline measurement?
Observer‐based outcome |
Unclear risk |
Comment:No baseline measure of our primary outcome. |
| Protection against contamination? |
Low risk |
Comment: practices were randomized. |
| Baseline characteristics patients |
Low risk |
Comment: reported and similar (See table 1). |
| Baseline characteristics healthcare professionals |
Low risk |
Comment: reported and similar (See table 1). |
