Mullan 2009.
Methods |
Study design: clinician‐randomized trial Unit of allocation: clinicians Unit of analysis: patient Power calculation: done |
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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 |
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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 |
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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 |
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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. |