Cross study heterogeneity has limited the evidence based evaluation of middle meningeal artery embolization (MMAE) as a treatment for chronic subdural hematoma (CSDH). Ongoing trials and prospective studies suggest that heterogeneity in upcoming publications may detract from subsequent meta-analyses and systemic reviews. This study aims to describe this data heterogeneity to promote harmonization with common data elements (CDEs) in publications. ClinicalTrials.gov and PubMed were searched for published or ongoing prospective trials of MMAE. The Nested Knowledge AutoLit living review platform was utilized to classify endpoints from randomized control trials (RCTs) and prospective cohort studies comparing MMAE with other treatments. The qualitative synthesis feature was used to determine cross study overlap of outcome related data elements. Eighteen studies were included: 12 RCTs, two non-randomized controlled studies, two prospective single arm trials, one combined prospective and retrospective controlled study, and one prospective cohort study. The most commonly reported data element was recurrence (15/18), but seven heterogenous (non-comparable) definitions were used for ‘recurrence’. Mortality was reported in 10/18 studies, but no common timepoint was reported in more than four studies. Re-intervention and CSDH volume were reported in eight studies, CSDH width in seven, and no other outcome was common across more than five studies. There was significant heterogeneity in data element collection even among prospective registered trials of MMAE. Even among CDEs, variation in definition and timepoints prevented harmonization. A standardized approach based on CDEs may be necessary to facilitate future meta-analyses and evidence driven evaluation of MMAE treatment of CSDH.
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GA and SG contributed equally.
Contributors All authors contributed to the study design and drafting of the manuscript. Search was completed by KMK, screening of articles by CS and DL, data extraction by GA, SG, KMK, and RT, with quality control by NH, SG, JF, and JH. Statistical analysis was provided by JP, and all authors contributed to feedback and finalization of the manuscript.
Funding Funding for the research and data gathering efforts were provided by Balt USA Inc.
Competing interests JJH is a consultant for Medtronic and MicroVention and is a member of the scientific and medical advisory board for iSchemaView. KMK works for and holds equity in Nested Knowledge Inc, works for Conway Medical LLC, and holds equity in Superior MedicalExperts Inc. NH works for and holds equity in Nested Knowledge Inc. ES and LS work for Nested Knowledge Inc. DFK has the following conflicts: ownership in Nested Knowledge Inc, Superior Medical Experts Inc, and Conway Medical LLC; research support from Microvention, Balt USA, and Medtronic. JF has the following conflicts: Imaging Core Lab for EMBOLISE (sponsor: Medtronic); research support from German Ministry of Science and Education (BMBF), German Ministry of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions- und Förderbank (IFB), Medtronic, Microvention, Route92, and Stryker; consultant for Acandis, Bayer, Boehringer Ingelheim, Cerenovus, Covidien, Medtronic, Medina, Microvention, Penumbra, Phenox, Stryker, and Transverse Medical; stock holder in Tegus Medical; deputy editor of J Neurointerv Surg. ASA is the primary investigator of the STEM Trial.
Provenance and peer review Not commissioned; externally peer reviewed.
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