Girgis 2009.

Study characteristics
Methods	Randomised trial, Australia
Participants	356 patients with non‐localised breast or colorectal cancer within 6 months of diagnosis Usual care mean age 57.4 years female 71.8% O/GP mean age 58.3 years female 72.3% TCW mean age 57.8 years female 72.5%
Interventions	Feedback of PROs via either a telephone caseworker or a oncologist/GP Anxiety and depression (HADS) Quality of Life (EORTC version 3) Perceived needs (Suportive Needs Survey‐Short Form)   Intervention features Multiple complex feedback (multiple PROMs at multiple times)  PROM(s) used as intervention: European Organisation for Research and Treatment of Cancer (EORTC QLQ‐C30), 34‐item Supportive Needs Survey‐SF (perceived needs), 10 items from the Needs Assessment for Advanced Cancer Patients Questionnaire (other prevalent needs) Constructs measured: Health related Quality of Life, Symptoms, Functioning Instrument categories/domains: Domain/Disease specific (cancer)   Administration features Where PROMs administered: Non‐clinical setting How administered: Interviewer‐administered Format of PROMs questionnaire(s): Electronic   Feedback features Format of PROMs feedback: Electronic, Paper How often information fed back: 3 times (baseline, 3 months, and 6 months) Who information fed back to: Clinicians Information fed back: Scores, Interpretation guidance, Management recommendations
Outcomes	Main outcome: impact of supportive care models Other outcomes: anxiety and depression (HADS), quality of Life (EORTC version 3), perceived needs (Suportive Needs Survey‐Short Form). The study period is not reported. The authors declare no conflicts of interest.
Notes	The study was funded by National Health and Medical Research Council of Australia Palliative Care Research (grant# 300807; Medical Benefits Fund of Australia; Hunter Medical Research Institute (infrastructure support); Afaf Girgis
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation performed quote: "using a computer‐generated algorithm".
Allocation concealment (selection bias)	Low risk	Computer‐generated randomisation at baseline
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	Unclear risk	No baseline outcome scores provided ‐ only at T2 and T3 in table 1
Baseline characteristics similar	Low risk	Paper states quote: "All groups had similar baseline demographic and clinical characteristics" (table provided).
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not reported
Was study protected against contamination	Unclear risk	GPs and oncologists nominated by control groups participants but intervention participants allocated case workers ‐ unclear as to whether either group could have had access to the other information
Selective reporting (reporting bias)	Unclear risk	Unclear whether selective reporting took place