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. 2021 Oct 12;2021(10):CD011589. doi: 10.1002/14651858.CD011589.pub2

Mazonson 1996.

Study characteristics
Methods Randomised trial, USA
Participants 573 adult patients with depression or anxiety.
Interventions Patient‐reported mental health information was fedback to clinicians.
 
Intervention features
Single complex feedback (multiple PROMs at a single time)
PROM(s) used as intervention: Anxiety and Depression Symptom Checklist (SCL‐90‐R), Functioning and well‐being measures (SF‐36), Diagnostic Interview schedule (DIS)
Constructs measured: Symptoms, Functioning
Instrument categories/domains: Generic, Domain/Disease specific (mental health)
 
Administration features
Where PROMs administered: Clinical setting (e.g. waiting room, office, etc)
How administered: Self‐administered
Format of PROMs questionnaire(s): Paper
 
Feedback features
Format of PROMs feedback: Paper
How often information fed back: Once
Who information fed back to: Clinicians
Information fed back: Scores, Previous scores, Interpretation guidance, Management recommendations
Outcomes Main outcomes: notation in chart, mental health referral, psychotropic medications.
Other outcomes: any hospitalisation, any office visit
Notes The study was supported by Upjohn Company, Kalamazoo, Mich. The study period was not reported. Conflicts of interest were not reported. 
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomly assigned
Allocation concealment (selection bias) High risk Patients were assiigned based on the assignment of the primary care physicians practice group
Blinding of participants and personnel (performance bias)
All outcomes High risk Physician practices rather than patients were randomised
Blinding of outcome assessment (detection bias)
All outcomes High risk Due to nature of the intervention blinding of outcomes not possible: PROM used for feedback also used to assess outcome, patients were aware they received the intervention.
Baseline outcome measurements similar Low risk Adjusted for analysis
Baseline characteristics similar Low risk There were no statistically significant differences between the intervention and control groups
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Not clearly reported
Was study protected against contamination Low risk To minimise contamination physicians and physician extenders were randomised to intervention or control by physician‐call group
Selective reporting (reporting bias) High risk None reported