Comparative Effectiveness of Surgery for Traumatic Acute Subdural Hematoma in an Aging Population

Essen, Thomas A. van; Dijkman, Mark D.; Cnossen, Maryse C.; Moudrous, Walid; Ardon, Hilko; Schoonman, Guus; Peul, Wilco C.; Lingsma, Hester F.; Ruiter, Godard C.W. de

doi:10.1089/neu.2018.5869

Cited by 21 publications

(15 citation statements)

References 42 publications

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“…IV analysis is becoming more popular in TBI research. Several recently published TBI studies analyzed effectiveness at the hospital level, 47 – 50 and a large European CER study is planning to use hospital-level analysis to assess effectiveness of many TBI interventions. 51 Previous studies typically divided hospitals into groups (e.g.…”

Section: Discussionmentioning

confidence: 99%

Adjusting for confounding by indication in observational studies: a case study in traumatic brain injury

Cnossen¹,

Essen²,

Ceyisakar³

et al. 2018

CLEP

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IntroductionObservational studies of interventions are at risk for confounding by indication. The objective of the current study was to define the circumstances for the validity of methods to adjust for confounding by indication in observational studies.Patients and methodsWe performed post hoc analyses of data prospectively collected from three European and North American traumatic brain injury studies including 1,725 patients. The effects of three interventions (intracranial pressure [ICP] monitoring, intracranial operation and primary referral) were estimated in a proportional odds regression model with the Glasgow Outcome Scale as ordinal outcome variable. Three analytical methods were compared: classical covariate adjustment, propensity score matching and instrumental variable (IV) analysis in which the percentage exposed to an intervention in each hospital was added as an independent variable, together with a random intercept for each hospital. In addition, a simulation study was performed in which the effect of a hypothetical beneficial intervention (OR 1.65) was simulated for scenarios with and without unmeasured confounders.ResultsFor all three interventions, covariate adjustment and propensity score matching resulted in negative estimates of the treatment effect (OR ranging from 0.80 to 0.92), whereas the IV approach indicated that both ICP monitoring and intracranial operation might be beneficial (OR per 10% change 1.17, 95% CI 1.01–1.42 and 1.42, 95% CI 0.95–1.97). In our simulation study, we found that covariate adjustment and propensity score matching resulted in an invalid estimate of the treatment effect in case of unmeasured confounders (OR ranging from 0.90 to 1.03). The IV approach provided an estimate in the similar direction as the simulated effect (OR per 10% change 1.04–1.05) but was statistically inefficient.ConclusionThe effect estimation of interventions in observational studies strongly depends on the analytical method used. When unobserved confounding and practice variation are expected in observational multicenter studies, IV analysis should be considered.

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Section: Discussionmentioning

confidence: 99%

Adjusting for confounding by indication in observational studies: a case study in traumatic brain injury

Cnossen¹,

Essen²,

Ceyisakar³

et al. 2018

CLEP

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“…Since the BTF guideline, which was based on merely retrospective studies with small or selected study populations that were performed more than 10 years before the guideline,5 10 11 46 there have been only some comparative studies. In our own retrospective analyses, early ASDH evacuation might be associated with lower odds of mortality and unfavourable outcome (GOS ≦3) 41. This is the first report showing an effect estimate of surgery for ASDH.…”

Section: Discussionmentioning

confidence: 68%

“…Importantly, the effect of surgery is probably not uniform, as is suggested by empirical evidence41 42 and by clinical experience. Therefore, effect modification by the following variables will be tested using interaction terms: GCS of ≥9, haematoma size >10 mm in diameter, midline shift >5 mm, time to treatment and baseline prognostic risk 30…”

Section: Methods and Designmentioning

confidence: 99%

Comparative effectiveness of surgery in traumatic acute subdural and intracerebral haematoma: study protocol for a prospective observational study within CENTER-TBI and Net-QuRe

et al. 2019

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IntroductionControversy exists about the optimal treatment for patients with a traumatic acute subdural haematoma (ASDH) and an intracerebral haematoma/contusion (t-ICH). Treatment varies largely between different regions. The effect of this practice variation on patient outcome is unknown. Here, we present the protocol for a prospective multicentre observational study aimed at comparing the effectiveness of different treatment strategies in patients with ASDH and/or t-ICH. Specifically, the aims are to compare (1) an acute surgical approach to an expectant approach and (2) craniotomy to decompressive craniectomy when evacuating the haematoma.Methods and analysisPatients presenting to the emergency room with an ASDH and/or an t-ICH are eligible for inclusion. Standardised prospective data on patient and injury characteristics, treatment and outcome will be collected on 1000 ASDH and 750 t-ICH patients in 60–70 centres within two multicentre prospective observational cohort studies: the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) and Neurotraumatology Quality Registry (Net-QuRe). The interventions of interest are acute surgery, defined as surgery directly after the first CT at presentation versus late or no surgery and craniotomy versus decompressive craniectomy. The primary outcome measure is the Glasgow Outcome Score-Extended at 6 months. Secondary outcome measures include in-hospital mortality, quality of life and neuropsychological tests. In the primary analysis, the effect of treatment preference (eg, proportion of patients in which the intervention under study is preferred) per hospital will be analysed with random effects ordinal regression models, adjusted for casemix and stratified by study. Such a hospital-level approach reduces confounding by the indication. Sensitivity analyses will include propensity score matching, with treatment defined on patient level. This study is designed to determine the best acute management strategy for ASDH and t-ICH by exploiting the existing between-hospital variability in surgical management.Ethics and disseminationEthics approval was obtained in all participating countries. Results of surgical management of ASDH and t-ICH/contusion will separately be submitted for publication in a peer-reviewed journal.Trial registration number NCT02210221 and NL 5761.

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“…Indeed, establishing causality based on non-randomized data is often impossible because of confounding by indication. A recent study comparing treatment strategy on a center level rather than on a patient level to reduce confounding by indication showed that an aggressive surgical management strategy was associated with better outcome in an elderly population with t-ASDH [ 30 ]. A systematic review regarding functional outcome of surgically and conservatively treated acute subdural hematoma patients is currently in the making [ 96 ].…”

Section: Discussionmentioning

confidence: 99%

“…Thus, no satisfactory conclusion regarding a preferred treatment strategy can be drawn from these studies. A recent study conducted by the authors, which compared treatment strategy on a center level rather than on a patient level to reduce confounding by indication, showed that an aggressive surgical management strategy was associated with better outcome in an elderly population with traumatic ASDHs [ 30 ]. Few studies have specified the type of intervention, and if they did, they did not address the effectiveness of the procedure [ 25 ].…”

Section: Introductionmentioning

confidence: 99%

Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma (RESET-ASDH trial): study protocol for a pragmatic randomized controlled trial with multicenter parallel group design

Singh¹,

Dijck²,

Essen³

et al. 2022

Trials

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Background The rapidly increasing number of elderly (≥ 65 years old) with TBI is accompanied by substantial medical and economic consequences. An ASDH is the most common injury in elderly with TBI and the surgical versus conservative treatment of this patient group remains an important clinical dilemma. Current BTF guidelines are not based on high-quality evidence and compliance is low, allowing for large international treatment variation. The RESET-ASDH trial is an international multicenter RCT on the (cost-)effectiveness of early neurosurgical hematoma evacuation versus initial conservative treatment in elderly with a t-ASDH Methods In total, 300 patients will be recruited from 17 Belgian and Dutch trauma centers. Patients ≥ 65 years with at first presentation a GCS ≥ 9 and a t-ASDH > 10 mm or a t-ASDH < 10 mm and a midline shift > 5 mm, or a GCS < 9 with a traumatic ASDH < 10 mm and a midline shift < 5 mm without extracranial explanation for the comatose state, for whom clinical equipoise exists will be randomized to early surgical hematoma evacuation or initial conservative management with the possibility of delayed secondary surgery. When possible, patients or their legal representatives will be asked for consent before inclusion. When obtaining patient or proxy consent is impossible within the therapeutic time window, patients are enrolled using the deferred consent procedure. Medical-ethical approval was obtained in the Netherlands and Belgium. The choice of neurosurgical techniques will be left to the discretion of the neurosurgeon. Patients will be analyzed according to an intention-to-treat design. The primary endpoint will be functional outcome on the GOS-E after 1 year. Patient recruitment starts in 2022 with the exact timing depending on the current COVID-19 crisis and is expected to end in 2024. Discussion The study results will be implemented after publication and presented on international conferences. Depending on the trial results, the current Brain Trauma Foundation guidelines will either be substantiated by high-quality evidence or will have to be altered. Trial registration Nederlands Trial Register (NTR), Trial NL9012. ClinicalTrials.gov, Trial NCT04648436.

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Comparative Effectiveness of Surgery for Traumatic Acute Subdural Hematoma in an Aging Population

Cited by 21 publications

References 42 publications

Adjusting for confounding by indication in observational studies: a case study in traumatic brain injury

Adjusting for confounding by indication in observational studies: a case study in traumatic brain injury

Comparative effectiveness of surgery in traumatic acute subdural and intracerebral haematoma: study protocol for a prospective observational study within CENTER-TBI and Net-QuRe

Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma (RESET-ASDH trial): study protocol for a pragmatic randomized controlled trial with multicenter parallel group design

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