Tolstrup 2020.
Study characteristics | ||
Methods | Randomised trial, Denmark. | |
Participants | 146 patients with multiple myeloma receiving immunotherapy. | |
Interventions | Symptom report using the PRO‐CTCAE with clinician feedback versus usual care. Intervention features Multiple complex feedback (multiple PROMs at multiple times) PROM(s) used as intervention: Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Event (PRO‐CTCAE) Constructs measured: Symptoms Instrument categories/domains: Generic, Domain/Disease specific (mental health) Administration features Where PROMs administered: Unclear How administered: Self‐administered Format of PROMs questionnaire(s): Electronic Feedback features Format of PROMs feedback: Unclear How often information fed back: Patients reported symptoms weekly but not clear if they were also fed back weekly Who information fed back to: Clinicians Information fed back: Unclear |
|
Outcomes | Main outcome: number of Grade 3 or 4 adverse events assessed by the Common Terminology for Cancer Adverse Events. | |
Notes | The study was funded by the Danish Cancer Society. The study period was not reported. Conflicts of interest were not reported. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information. |
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 | Insufficient information. |
Baseline outcome measurements similar | Low risk | Baseline outcome measurements are similar. |
Baseline characteristics similar | Unclear risk | Baseline characteristics are similar. Statistical tests conducted. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information. |
Was study protected against contamination | High risk | Single‐centre study. Clinicians can treat patients in intervention and control group. |
Selective reporting (reporting bias) | Low risk | Pre‐publication information available. |