Dowrick 1995b.

Study characteristics
Methods	Randomised trial, UK
Participants	179 adults with a positive depression screen attending primary care.
Interventions	Feedback plus additional interventions (patients and clinicians).   Intervention features Single simple feedback (one PROM at a single time) PROM(s) used as intervention: Beck Depression Inventory (BDI) Constructs measured: Symptoms Instrument categories/domains: Domain/Disease specific (mental health)   Administration features Where PROMs administered: Clinical  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, Interpretation guidance
Outcomes	Main outcome: depression scores (measured with the BDI‐21)
Notes	No funding declared. The study was conducted in 1993. The authors reported no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Participants were randomly subdivided on a 6:5 ratio (to allow later diagnoses to be discounted in assessing changes in depressing status)
Allocation concealment (selection bias)	Low risk	Allocated using sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible due to study design (intervention group received graphical summary of questionnaire results)
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	There were no statistically significant differences between the intervention and control groups
Baseline characteristics similar	Low risk	There were no significant differences between the two groups in terms of age, gender, civil, employment or physical health status.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	An ‘intention‐to‐treat’ analysis was performed
Was study protected against contamination	High risk	The researcher performing the interview and analysing the data were aware that the patient was a participant in the study
Selective reporting (reporting bias)	Low risk	All relevant outcomes in the methods section are reported in the results section