Common data elements reported on middle meningeal artery embolization in chronic subdural hematoma: an interactive systematic review of recent trials

TY - JOUR

T1 - Common data elements reported on middle meningeal artery embolization in chronic subdural hematoma: an interactive systematic review of recent trials

AU - Adusumilli, Gautam

AU - Ghozy, Sherief

AU - Kallmes, Kevin M

AU - Hardy, Nicole

AU - Tarchand, Ranita

AU - Zinn, Caleb

AU - Lamar, Duncan

AU - Singeltary, Emily

AU - Siegel, Lauren

AU - Kallmes, David F

AU - Arthur, Adam S

AU - Gellissen, Susanne

AU - Fiehler, Jens

AU - Heit, Jeremy J

N1 - © Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2022/10

Y1 - 2022/10

N2 - 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.

AB - 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.

KW - Common Data Elements

KW - Embolization, Therapeutic

KW - Hematoma, Subdural, Chronic/diagnostic imaging

KW - Humans

KW - Meningeal Arteries/diagnostic imaging

KW - Prospective Studies

U2 - 10.1136/neurintsurg-2021-018430

DO - 10.1136/neurintsurg-2021-018430

M3 - SCORING: Review article

C2 - 35135849

VL - 14

SP - 1027

EP - 1032

JO - J NEUROINTERV SURG

JF - J NEUROINTERV SURG

SN - 1759-8478

IS - 10

ER -