Reporting standards in randomized controlled trials involving neuro-oncology caregivers: A systematic review report from the RANO-Cares working group.

Abstract

Background: Family caregivers in neuro-oncology (eg, spouse, family member, friend to a patient) have high unmet support needs, yet intervention trials and effective support options are scarce. The Response Assessment in Neuro-Oncology (RANO)-Cares working group investigated the methodological quality of neuro-oncology caregiver outcomes reporting in randomized controlled trials (RCTs).

Methods: A systematic review was performed to evaluate to what extent RCTs assessing outcomes of caregivers of adult primary brain tumor patients adhere to minimum reporting standards. A 33-item checklist (23 applicable to secondary analysis reports) based on the International Society for Quality of Life Research (ISOQOL) criteria for patient-reported outcome reporting was used. Risk of bias was assessed per RCT.

Results: Fifteen publications from 11 unique RCTs included 676 neuro-oncology caregivers, with low overall risk of bias. Ten publications (66%) reported on caregiver outcomes as a primary aim, of which 8 (80%) satisfied ≥2/3 of the key methodological criteria. Of the 5 secondary analysis reports (33%), 2 (40%) met ≥2/3 of applicable key criteria. Criteria often not reported adequately included sample size calculations (reported adequately in n = 8, 53%), participant flow (n = 9, 60%) window for data collection (n = 1, 6%), and extent of (n = 10, 66%), reasons for (n = 9, 60%), and statistical approaches in dealing with (n = 4, 26%) missing data.

Conclusions: Whilst there are opportunities to enhance reporting standards, RCTs that include neuro-oncology caregiver outcomes generally adhere to high-quality reporting standards and have low risk of bias, indicating good potential to impact clinical practice.