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 |
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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. |
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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 |