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

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.