Picardi 2016.

Study characteristics
Methods	Randomised trial, Italy
Participants	115 patients in 13 primary care practices who screened positive for depression and did not report suicidal ideation.
Interventions	Those who screened positive and did not report suicidal ideation were randomised to an intervention group (communication of the result and offer of psychiatric evaluation and treatment free of charge; 56) or a control group (no feedback on test result for 3 months; 59).   Intervention features Single complex feedback (multiple PROMs at a single time)  PROM(s) used as intervention: The 5‐item version of the PC‐SAD (PC‐SAD5), WHOQOL‐Bref Constructs measured: Health related Quality of Life, 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: Electronic How often information fed back: Once Who information fed back to: Clinicians Information fed back: Scores
Outcomes	Main outcomes: depression (PC‐SAD), QoL (WHOQOL‐Bref)
Notes	The study was funded by Italian Ministry of Health in the framework of the ‘Programma Ricerca Finalizzata 2006’. The study ran from January2009 to June 2010.  Conflicts of interest were not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated simple randomisation list.
Allocation concealment (selection bias)	Low risk	Participants were given an envelope containing a sociodemographic form and the Primary Care Screener for Affective Disorders (PC‐SAD) and WHOQOL‐Bref questionnaires to complete. Participants placed the completed questionnaires back in the envelope, and they put it in a transparent drop box located in the waiting room. The PC‐SAD was scored through an automated system by a researcher who was not involved in subsequent assessments.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to nature of intervention not possible to blind patients and personnel.
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	No significant differences in baseline.
Baseline characteristics similar	Low risk	Baseline characteristics of the study and control providers are reported and similar.
Incomplete outcome data (attrition bias) All outcomes	Low risk	87% of randomised patients (intervention group,N = 46; control group,N = 54) completed the 3‐month assessment.
Was study protected against contamination	Low risk	Control group had no access to the intervention.
Selective reporting (reporting bias)	Low risk	None apparent.