Florien W Boele, Caroline Hertler, Paula Sherwood, David Cachia, Linda Dirven, Jacob S Young, Tobias Walbert, Macy Stockdill, Eduardo Rodriguez Almaraz, Karin Piil
{"title":"Reporting standards in randomized controlled trials involving neuro-oncology caregivers: A systematic review report from the RANO-Cares working group.","authors":"Florien W Boele, Caroline Hertler, Paula Sherwood, David Cachia, Linda Dirven, Jacob S Young, Tobias Walbert, Macy Stockdill, Eduardo Rodriguez Almaraz, Karin Piil","doi":"10.1093/nop/npae086","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 <i>n</i> = 8, 53%), participant flow (<i>n</i> = 9, 60%) window for data collection (<i>n</i> = 1, 6%), and extent of (<i>n</i> = 10, 66%), reasons for (<i>n</i> = 9, 60%), and statistical approaches in dealing with (<i>n</i> = 4, 26%) missing data.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":19234,"journal":{"name":"Neuro-oncology practice","volume":"12 1","pages":"19-33"},"PeriodicalIF":2.4000,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11798602/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neuro-oncology practice","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/nop/npae086","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍:
Neuro-Oncology Practice focuses on the clinical aspects of the subspecialty for practicing clinicians and healthcare specialists from a variety of disciplines including physicians, nurses, physical/occupational therapists, neuropsychologists, and palliative care specialists, who have focused their careers on clinical patient care and who want to apply the latest treatment advances to their practice. These include: Applying new trial results to improve standards of patient care Translating scientific advances such as tumor molecular profiling and advanced imaging into clinical treatment decision making and personalized brain tumor therapies Raising awareness of basic, translational and clinical research in areas of symptom management, survivorship, neurocognitive function, end of life issues and caregiving