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

Rand 1988.

Study characteristics
Methods Randomised trial, USA
Participants 32 residents and 1040 patients visiting a family practice site. Participants were mainly between the ages of 18 to 40 years and female
Interventions Participants in the experimental group were provided feedback on the GHQ by the residents.
 
Intervention features
Single simple feedback (one PROM at a single time)
PROM(s) used as intervention: GHQ‐28
Constructs measured: Symptoms
Instrument categories/domains: 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
Outcomes Main outcomes: psychiatric screening (GHQ), chart audit form (psychologic or psychiatric of condition, and patient demographics (sex, race, age))
Notes The study was funded by University of Alabama and College of Community Health Sciences Research Grants Committees. The study period was not reported. The authors declared no conflicts of interest.
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation method not specified.
Allocation concealment (selection bias) High risk Allocation concealment not possible due to cluster‐randomisation
Blinding of participants and personnel (performance bias)
All outcomes High risk Not possible to blind physicians
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 Outcome measurements were similar at baseline.
Baseline characteristics similar Low risk Table is provided and paper states that no significant differences between groups were found.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Missing data were not mentioned in terms of how it was handled statistically
Was study protected against contamination Low risk Sites were randomised but it was not clear whether the sites were in contact with each other
Selective reporting (reporting bias) Low risk None apparent.