Lugtenberg 2020.
Study characteristics | ||
Methods | Randomised trial, the Netherlands. | |
Participants | 113 patients with Stage I‐IIIB breast cancer treated with chemotherapy. | |
Interventions | Scores from a PROM assessing quality of life, distress, and care needs fed back to clinicians before chemotherapy cycles vs. usual care. Intervention features Multiple complex feedback (multiple PROMs at multiple times) PROM(s) used as intervention: The European Organization for Research and Treatment of Cancer BR‐23 breast cancer questionnaire, The Care Notebook (CNB), The National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT), One free text dialog box (patients were invited to list topics or specific questions they would like to discuss with their HCP during their next hospital visit), One question assessing additional supportive care needs. Constructs measured: Health related Quality of Life, Symptoms, Functioning, other (additional supportive care needs) Instrument categories/domains: Domain/Disease specific (cancer) Administration features Where PROMs administered: Non‐clinical setting How administered: Self‐administered Format of PROMs questionnaire(s): Unclear Feedback features Format of PROMs feedback: Electronic How often information fed back: 3 episodes of recording. Fed back on second and third visit Who information fed back to: Clinicians Information fed back: Scores, Interpretation guidance |
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Outcomes | Primary outcome: number of quality of life topics discussed prior to chemotherapy initiation. | |
Notes | Funded by Dutch Pink Ribbon Foundation and Pfizer, Japan. The study period was not reported. The authors declared no conflicts of interest. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation tool not described. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded by nature of intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
Baseline outcome measurements similar | Low risk | Baseline measurement the same. |
Baseline characteristics similar | Low risk | Baseline characteristics similar. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Missing data not dealt with. |
Was study protected against contamination | High risk | Randomisation at the patient level. |
Selective reporting (reporting bias) | High risk | No protocol. |