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

Mullan 2009.

Methods Study design: clinician‐randomized trial
Unit of allocation: clinicians
Unit of analysis: patient
Power calculation: done
Participants Setting of care: primary care, ambulatory care, USA
Healthcare professionals: 40; various healthcare professional and inter‐professional (physicians, physicians assistant, nurse practitioners managing diabetes); Fully trained and residents
Patients: 85; diabetes type 2; males and females
Interventions Multifaceted intervention: patient‐mediated intervention (decision aid used during the clinical encounter); and educational training (how to use decision aid)
Quote: "[The Diabetes Medication choice decision aid tool]  is designed to enable clinicians to discuss with patients the potential advantages and disadvantages of adding an [antihyperglycemics pharmaceutical] agent." page 1562
« Ideally, the clinician presents all 6 cards [describing the possible side effect of the medication] to the patient and asks which of the cards the patient would like to discuss first. After reviewing and discussing the cards that the patient and the clinician choose [what] to discuss." page 1562
Quote; "The patient receives a copy of the cards in the form of a take‐home pamphlet." page 1562
"Clinicians randomised to the intervention arm received a brief demonstration from the study coordinator on how to use the decision aid prior to meeting the first enrolled patient." page 1562
Single intervention (control): patient‐mediated intervention (decision aid). Quote: "... 12‐page general pamphlet on oral antihyperglycemics medication to take home." page 1562
Outcomes OPTION (continuous, score) and validated pictorial instrument ; SDM is assessed as the fostering by healthcare professionals of active participation of patients in the decision‐making process.
Notes Additional information
Number of approached patients (eligible): 1341
Number of patients per physician: at least one, page 1563
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A computer‐generated allocation sequence, unavailable to personnel enrolling patients or clinicians, randomized clinicians to intervention (decision aid) or usual care and was accessed by the study coordinators via telephone." page 1562
Allocation concealment (selection bias) Low risk Quote: "A computer‐generated allocation sequence, unavailable to personnel enrolling patients or clinicians, randomized clinicians to intervention (decision aid) or usual care and was accessed by the study coordinators via telephone." page 1562
Blinding (performance bias and detection bias) 
 Observer‐based outcome 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) 
 Observer‐based outcome Low risk Comment: 18 vs 16 visits were recorded. In both groups reasons were either because patient/clinician did not wish to be recorded or technical difficulties.
Incomplete outcome data (attrition bias) 
 Participant‐reported outcome Low risk Comment: lost to follow‐up patients were balanced in number and reasons across groups (fig 2).
Selective reporting (reporting bias) High risk Comment: the PROM was not reported (validated pictorial instrument).
Other bias Low risk Comment: no evidence of other risk of biases.
Baseline measurement? 
 Observer‐based outcome Unclear risk Comment: not specified in the paper.
Baseline measurement? 
 Participant‐reported outcome Unclear risk Comment: not specified in the paper.
Protection against contamination? Unclear risk Comment: unit of allocation is the clinician and not separated by primary care and family medicine sites.
Baseline characteristics patients Low risk Comment: see table 1.
Baseline characteristics healthcare professionals Unclear risk Comment: insufficient data about provider in table 1. There are more physicians and nurses in the DA group.