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. 2021 Oct 12;2021(10):CD011589. doi: 10.1002/14651858.CD011589.pub2

Rosenbloom 2007.

Study characteristics
Methods Randomised trial, USA
Participants 213 adults with metastatic breast, lung or colorectal cancer
Interventions 3 arm: usual care, HRQL assessment, HRQL assessment + structured interview and discussion.
 
Intervention features
Multiple complex feedback (multiple PROMs at multiple times) 
PROM(s) used as intervention: Functional Assessment of Cancer Therapy‐General (FACT‐G), Functional Living Index‐Cancer (FLIC), Brief Profile of Mood States (Brief POMS‐17)
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) 
How administered: Self‐administered and interviewer‐administered
Format of PROMs questionnaire(s): Unclear
 
Feedback features
Format of PROMs feedback: Unclear
How often information fed back: Baseline and 1, 2, 3, 6 months
Who information fed back to: Clinicians, Patients
Information fed back: Scores, Previous scores
Outcomes HRQL: Functional Living Index Cancer (FLIC); Brief Profile of Mood States (Brief POMS‐17) for distress outcomes; Medical Outcomes Study Patient Satisfaction Questionnaire‐ III (PSQ‐III) for satisfaction with medical treatment. Lastly a composite clinical treatment change variable was computed.
Notes Study was funded by American Cancer Society (grant #PBR 6132); National Cancer Institute (grant #R29 CA51926).The study was conducted between 1990 and 1992.  Conflicts of interest were not reported. 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation procedure not stated.
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 Not possible due to study design
Blinding of outcome assessment (detection bias)
All outcomes High risk Not possible due to study design
Baseline outcome measurements similar Low risk All baseline assessments were of similar levels
Baseline characteristics similar Low risk Table of patient demographics and clinical characteristics provided. No significant P values returned.
Incomplete outcome data (attrition bias)
All outcomes Low risk Missing data was examined using AUC and models created to which there were no significant differences found
Was study protected against contamination Low risk Data from the control group (non‐assessment control) were not shared with the treatment nurses
Selective reporting (reporting bias) Low risk Unclear whether selective reporting took place