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

Barton 2016.

Methods Study design: non‐randomized trial
Unit of allocation: patient
Unit of analysis: patient
Power calculation: done
Participants Care setting: ambulatory care, specialized care, USA
Health professionals: unclear type; fully trained
Patients: 166; rheumatoid arthritis; male and female
Interventions Single intervention ‐ patient‐mediated intervention: (adapted guide prior to visit)Patient‐mediated intervention
 Quote: "Briefly, the existing AHRQ guide was discussed in patient and clinician focus groups; transcripts and field notes were analyzed and informed the content of the adapted guide, which included chapters on “What is RA?” and “What can RA medicines do for you?” The design and development process for RA Choice was based on a tool created for diabetes mellitus medications for use in the clinic to facilitate a conversation between clinician and patient. Tool development involved field‐testing low‐fidelity prototypes (drafts or incomplete versions) in real clinical encounters followed by modifications and iterative field testing." page 891. "All participating clinicians received brief (5 minutes), in‐person training about RA Choice." page 891
Single intervention ‐ patient‐mediated intervention: (adapted guide + decision aid during visit )
 Literacy‐appropriate medication guide and decision aid (RA Choice)
Single intervention ‐ patient‐mediated intervention: Control Group
Quote: "Patients received existing medication guide prior to clinic visit." page 889
Outcomes The Interpersonal Processes of Care (IPC) (Continous)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "We used this method rather than randomizing by physician to allow for the broadest possible group of physicians to participate in arm 3, to allow for additional time to complete the design and testing of materials, and to avoid contamination of the groups." page 890
Allocation concealment (selection bias) High risk Quote: "After completing enrollment for the control group, patients were enrolled into arm 2, in which patients received the adapted guide prior to the clinic visit, and then into arm 3, where patients received the adapted guide prior to the visit and the decision aid (used in the clinical encounter). We used this method rather than randomizing by physician to allow for the broadest possible group of physicians to participate in arm 3, to allow for additional time to complete the design and testing of materials, and to avoid contamination of the groups." page 890
Blinding (performance bias and detection bias) 
 Participant‐reported outcome Unclear risk Comment: insufficient information to make a judgement.
Incomplete outcome data (attrition bias) 
 Participant‐reported outcome Unclear risk Comment: insufficient information to make a judgement.
Selective reporting (reporting bias) Unclear risk Comment: study protocol not available.
Other bias Low risk Comment: no evidence of other risk of biases.
Baseline measurement? 
 Participant‐reported outcome Unclear risk Comment: no baseline measure of our primary outcome.
Protection against contamination? Low risk Quote: "We used this method rather than randomizing by physician to allow for the broadest possible group of physicians to participate in arm 3, to allow for additional time to complete the design and testing of materials, and to avoid contamination of the groups" page 890
Baseline characteristics patients Low risk Quote: "There were no significant differences in characteristics across the 3 study arms with the exception of sex (more women in arms 1 and 3; P 5 0.02) and clinic site (78% in arm 1 were from the county hospital compared to 60% each in arms 2 and 3) the possibility that patients enrolled in arm 1 may have differed in characteristics from those in arm 2 or 3; however, the only significant differences were in sex and clinic site 2‐ Adjusted models control for clinic site and sex." page 893
Baseline characteristics healthcare professionals Unclear risk Comment: No report of characteristics