Gutteling 2008.

Study characteristics
Methods	Randomised trial. the Netherlands
Participants	162 adults (mean age 48 years)
Interventions	Computerized HRQOL assessment completed and feedback graphically to clinicians.   Intervention features Multiple complex feedback (multiple PROMs at multiple times)  PROM(s) used as intervention: 12‐Item Short Form Survey (SF‐12), PCS Physical Component Summary, MCS Mental Component Summary, LDSI 2.0 Liver Disease Symptom Index 2.0 Constructs measured: Health related Quality of Life, Symptoms, Functioning Instrument categories/domains: Generic, Domain/Disease specific (liver disease, mental health)   Administration features Where PROMs administered: Clinical setting How administered: Self‐administered Format of PROMs questionnaire(s): Electronic   Feedback features Format of PROMs feedback: Electronic How often information fed back: Before each consultation for the duration of one year Who information fed back to: Clinicians Information fed back: Scores, Previous scores, Interpretation guidance
Outcomes	Main outcomes: generic HRQOL (measured with the SF‐12), disease‐specific HRQOL (measured with the LDSI 2.0)
Notes	No funding declared. The study was initiated between September 2004 and September 2005. Conflicts of interest were not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Restricted randomisation procedure through blocking
Allocation concealment (selection bias)	High risk	Due to cluster‐randomised design not possible to conceal allocation from clinicians.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the intervention, it was impossible to blind physicians to group assignment
Blinding of outcome assessment (detection bias) All outcomes	High risk	The PROM used for feedback was also used for outcome assessment
Baseline outcome measurements similar	Low risk	Adjusted for analysis
Baseline characteristics similar	Low risk	There were statistically significant differences between the intervention and control groups
Incomplete outcome data (attrition bias) All outcomes	Low risk	Out of 327, 162 patients were included in the data analyses
Was study protected against contamination	Low risk	physicians rather than patients were randomly assigned to either the intervention or control group.
Selective reporting (reporting bias)	Low risk	None reported