Abstract
BACKGROUND: Family caregivers in neuro-oncology consistently report high levels of unmet support needs, yet intervention trials and effective support options are scarce. To raise the standard of caregiver-related research reporting in neuro-oncology, the Response Assessment in Neuro-Oncology (RANO-) Cares working group has been established. We investigated the current state of methodological quality of reporting on neuro-oncology caregiver outcomes in randomized controlled trials (RCTs). MATERIAL AND METHODS: A systematic literature review (PubMed/Medline, Embase, Web of Science, Emcare, Cochrane Library, PsycINFO; July 2023) was performed to evaluate to what extent RCTs assessing outcomes of family caregivers of adult primary brain tumour patients adhere to minimum reporting standards. Using Covidence, screening and data extraction was done by two researchers independently, with a third guiding consensus. 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 (PRO) reporting was used to review each article. Risk of bias was assessed per RCT. RESULTS: Fifteen publications (12 RCTs) included 684 neuro-oncology caregivers, with low overall risk of bias. Ten publications (66%) reported on caregiver outcomes as a primary aim, of which eight (80%) satisfied ≥2/3 of the key methodological criteria. Of the five secondary analysis reports (33%) two (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. Unpublished outcome measures were seldom supplied as supplementary material (2/12 publications, 16%). CONCLUSION: 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 evidence-based, clinical practice.