Franco 2020.

Study characteristics
Methods	Randomised trial. Italy.
Participants	222 patients with uncontrolled epileptic seizures.
Interventions	Assessment of adverse events using the Adverse Event Profile (AEP) and communication of patient scores to treating physicians.    Intervention features Multiple complex feedback (multiple PROMs at multiple times)  PROM(s) used as intervention: 31‐item epilepsy‐specific Quality of Life Inventory ‐ Epilepsy–31 (QOLIE‐31), 19‐item AEP questionnaire, Beck Depression Inventory II (BDI), 5‐digit Clinical Global Impression (CGI) scale Constructs measured: Health related Quality of Life, Symptoms, Functioning Instrument categories/domains: Generic, Domain/Disease specific (epilepsy)   Administration features Where PROMs administered: Clinical setting How administered: Self‐administered Format of PROMs questionnaire(s): Electronic   Feedback features Format of PROMs feedback: Unclear How often information fed back: 0 (enrolment), 6, 12, and 18 months Who information fed back to: Clinicians Information fed back: Scores
Outcomes	Main outcome: adverse events measured by the AEP and quality of life measured by the Quality of Life Inventory for Epilepsy‐31 (QOLIE‐31).
Notes	Funded by the Italian Medicines Agency (Agenzia Italiana del Farmaco [AIFA]) (FARM52K2WM_003) and the University Pavia. The study was conducted between 2006 and 2009. No conflicts of interest are reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation.
Allocation concealment (selection bias)	Low risk	Secure online system delivered allocation.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Nature of intervention.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported.
Baseline outcome measurements similar	Low risk	Measurements the same.
Baseline characteristics similar	Low risk	Characteristics similar.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not reported.
Was study protected against contamination	High risk	Multi‐site no cluster design.
Selective reporting (reporting bias)	Unclear risk	No published protocol.