Detmar 2002.

Study characteristics
Methods	Randomised trial, the Netherlands
Participants	214 adult patients undergoing outpatient palliative chemotherapy after at least 2 cycles of chemotherapy Mean age 57 years Female 76%
Interventions	HRQL (QLQ‐C30 version 3.0) with feedback for physician and patient before consultation Patient management (with audiotapes of consultations) Physician's awareness of patients' health problems (comparing COOP and WONCA between physician and patient) Patients self‐reported HRQL (SF‐36) Patient and physician evaluation of intervention (questionnaire and telephone interview regarding their experience with the intervention)   Intervention features Multiple complex feedback (multiple PROMs at multiple times)  PROM(s) used as intervention: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire‐Core 30 (QLQ‐C30) Constructs measured: Health related Quality of Life, Symptoms, Functioning Instrument categories/domains: Domain/Disease specific (cancer)   Administration features Where PROMs administered: Clinical setting How administered: Self‐administered Format of PROMs questionnaire(s): Paper   Feedback features Format of PROMs feedback: Paper How often information fed back: At 3 successive outpatient visits Who information fed back to: Clinicians, Patients Information fed back: Scores, Previous scores, Interpretation guidance
Outcomes	Main outcome: patient‐physician communication Other outcomes: physician awareness of patients' HRQL (agreement between physician and patients' reporting of problems)
Notes	The study was supported by the Dutch Cancer Society. The study ran from June 1996 to June 1998. Conflicts of interest were not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Cross‐over design and the physicians took part in both the intervention and control
Allocation concealment (selection bias)	High risk	Not possible to blind clinicians due to study design.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible due to study design (intervention group received graphical summary of questionnaire results)
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	Table 1 shows similar baseline results of the outcome measurements
Baseline characteristics similar	Low risk	Table provided and paper states: "The intervention and control groups were well‐balanced on variables except primary diagnosis, with the control group having proportionally more breast cancer patients than the intervention group."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comparisons were made between those complete datasets and those who did not complete the follow‐ups
Was study protected against contamination	High risk	Cross‐over design so contamination likely
Selective reporting (reporting bias)	Low risk	None apparent.