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 |
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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 |