Velikova 2004.

Study characteristics
Methods	Randomised trial, UK
Participants	286 cancer patients visiting the Leeds cancer centre. mean age participants 54.9years. 73% female.
Interventions	Use of health‐related quality‐of‐life (HRQL) data in oncology practice.   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), Hospital Anxiety and Depression Scale (HADS) Constructs measured: Health related Quality of Life, Symptoms, Functioning Instrument categories/domains: Domain/Disease specific (mental health, cancer)   Administration features Where PROMs administered: Clinical setting (e.g. waiting room, office, etc) and non‐clinical setting How administered: Self‐administered, Interviewer‐administered Format of PROMs questionnaire(s): Electronic, Paper   Feedback features Format of PROMs feedback: Paper How often information fed back: Before every encounter for approximately 6 months Who information fed back to: Clinicians Information fed back: Scores, Previous scores, Interpretation guidance
Outcomes	Main outcomes: HRQOL over time using FACT, physician‐patient communication, clinical management measured by content analysis of audiotaped‐recorded encounters.
Notes	The study was supported by Cancer Research UK; National Lotteries Charities Board; National Health Service Research and Development. The study period was not reported. The authors declared no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The random assignment was stratified by site of cancer in random permuted blocks. Random assignment was carried out by telephone, by the Administrative Office at Cancer Research UK Centre
Allocation concealment (selection bias)	Unclear risk	No mention of who knew about the allocations
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	All baseline assessments were of similar levels
Baseline characteristics similar	Low risk	All baseline characteristics were similar between the groups
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Intention‐to‐treat analysis
Was study protected against contamination	Unclear risk	Unsure as to whether contamination could be possible
Selective reporting (reporting bias)	Unclear risk	Unclear whether selective reporting took place