Consolidated Health Economic Evaluation Reporting Standards in Neurosurgery

Consolidated Health Economic Evaluation Reporting Standards

Economic evaluations of health interventions pose a particular challenge for reporting. There is also a need to consolidate and update existing guidelines and promote their use in a user friendly manner. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines efforts into one current, useful reporting guidance. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication.


The increasing number of treatment options and the high costs associated with epilepsy have fostered the development of economic evaluations in epilepsy. It is important to examine the availability and quality of these economic evaluations and to identify potential research gaps. As well as looking at both pharmacologic (antiepileptic drugs [AEDs]) and nonpharmacologic (e.g., epilepsy surgeryketogenic dietvagus nerve stimulation) therapies, a review of Wijnen et al., examines the methodologic quality of the full economic evaluations included. Literature search was performed in MEDLINE, EMBASE, NHS Economic Evaluation Database (NHS EED), Econlit, Web of Science, and CEA Registry. In addition, Cochrane Reviews, Cochrane DARE and Cochrane Health Technology Assessment Databases were used. To identify relevant studies, predefined clinical search strategies were combined with a search filter designed to identify health economic studies. Specific search strategies were devised for the following topics: (1) AEDs, (2) patients with cognitive deficits, (3) elderly patients, (4) epilepsy surgery, (5) ketogenic diet, (6) vagus nerve stimulation, and (7) treatment of (non)convulsive status epilepticus. A total of 40 publications were included in this review, 29 (73%) of which were articles about pharmacologic interventions. Mean quality score of all articles on the Consensus Health Economic Criteria (CHEC)-extended was 81.8%, the lowest quality score being 21.05%, whereas five studies had a score of 100%. Looking at the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), the average quality score was 77.0%, the lowest being 22.7%, and four studies rated as 100%. There was a substantial difference in methodology in all included articles, which hampered the attempt to combine information meaningfully. Overall, the methodologic quality was acceptable; however, some studies performed significantly worse than others. The heterogeneity between the studies stresses the need to define a reference case (e.g., how should an economic evaluation within epilepsy be performed) and to derive consensus on what constitutes “standard optimal care” 1).


The in-hospital treatment of patients with traumatic brain injury (TBI) is considered to be expensive, especially in patients with severe traumatic brain injury. To improve future treatment decision-making, resource allocation and research initiatives, a study of van Dijck et al., from The Netherlands reviewed the in-hospital costs for patients with s-TBI and the quality of study methodology.

systematic review was performed using the following databases: PubMedMEDLINEEmbaseWeb of ScienceCochrane libraryCENTRALEmcarePsycINFOAcademic Search Premier and Google ScholarArticles published before August 2018 reporting in-hospital acute care costs for patients with s-TBI were included. Quality was assessed by using a 19-item checklist based on the CHEERS statement.

Twenty-five out of 2372 articles were included. In-hospital costs per patient were generally high and ranged from $2,130 to $401,808. Variation between study results was primarily caused by methodological heterogeneity and variable patient and treatment characteristics. The quality assessment showed variable study quality with a mean total score of 71% (range 48% – 96%). Especially items concerning cost data scored poorly (49%) because data source, cost calculation methodology and outcome reporting were regularly unmentioned or inadequately reported.

Healthcare consumption and in-hospital costs for patients with s-TBI were high and varied widely between studies. Costs were primarily driven by the length of stay and surgical intervention and increased with higher TBI severity. However, drawing firm conclusions on the actual in-hospital costs of patients sustaining s-TBI was complicated due to variation and inadequate quality of the included studies. Future economic evaluations should focus on the long-term cost-effectiveness of treatment strategies and use guideline recommendations and common data elements to improve study quality 2).

References

1)

Wijnen BFM, van Mastrigt GAPG, Evers SMAA, Gershuni O, Lambrechts DAJE, Majoie MHJM, Postulart D, Aldenkamp BAP, de Kinderen RJA. A systematic review of economic evaluations of treatments for patients with epilepsy. Epilepsia. 2017 May;58(5):706-726. doi: 10.1111/epi.13655. Epub 2017 Jan 18. Review. PubMed PMID: 28098939.
2)

van Dijck JTJM, Dijkman MD, Ophuis RH, de Ruiter GCW, Peul WC, Polinder S. In-hospital costs after severe traumatic brain injury: A systematic review and quality assessment. PLoS One. 2019 May 9;14(5):e0216743. doi: 10.1371/journal.pone.0216743. eCollection 2019. PubMed PMID: 31071199.

Epilepsy after cranioplasty

Epilepsy after cranioplasty

Among the several cranioplasty complicationsepilepsy is a common complication with an incidence of 14.8-33.0% 1) 2).

Antiepileptic drugs can effectively reduce the occurrence of seizure3).

Systematic review

Seizures are a recognised complication of cranioplasty but its incidence and risk factors in TBI patients are unclear. Accurate prognostication can help direct prophylactic and treatment strategies for seizures. In a systematic review, Spencer et al., aimed to evaluate current literature on these factors. A PROSPERO-registered systematic review was performed in accordance with PRISMA guidelines. Data was synthesised qualitatively and quantitatively in meta-analysis where appropriate. A total of 8 relevant studies were identified, reporting 919 cranioplasty patients. Random-effects meta-analysis reveals a pooled incidence of post-cranioplasty seizures (PCS) of 5.1% (95% CI 2.6-8.2%). Identified risk factors from a single study included increasing age (OR 6.1, p = 0.006), contusion at cranioplasty location (OR 4.8, p = 0.015), and use of monopolar diathermy at cranioplasty (OR 3.5, p = 0.04). There is an association between an extended DC-cranioplasty interval and PCS risk although it did not reach statistical significance (p = 0.062). Predictive factors for PCS are poorly investigated in the TBI population to date. Heterogeneity of included studies preclude meta-analysis of risk factors. Further studies are required to define the true incidence of PCS in TBI and its predictors, and trials are needed to inform management of these patients. 4).

Case series

Two hundred and thirty-eight patients who received cranioplasty following craniectomy between January 2012 and December 2014 were included in a study. The risk factors of the patients with early and late post-cranioplasty seizures were compared to those with no post-cranioplasty seizures.

Seizures (73/238, 30.3%) were the most common complication after cranioplasty. Of these 73 patients, 17 (7.1%) had early post-cranioplasty seizures and 56 (23.5%) had late post-cranioplasty seizures. Early post-cranioplasty seizures were related to a longer interval between craniectomy and cranioplasty (P = 0.006), artificial materials (P < 0.001), and patients with late post-craniectomy seizures (P = 0.001). Late post-cranioplasty seizures were related to the presence of neurological deficits (P = 0.042). After stepwise logistic regression analysis, a longer interval between craniectomy and cranioplasty (P = 0.012; OR: 1.004, 95% CI: 1.001-1.007) and late post-craniectomy seizures (P = 0.033; OR: 4.335, 95% CI: 1.127-16.675) were independently associated with early post-cranioplasty seizures.

Delayed cranioplasty procedures and seizures before cranioplasty were significantly associated with early post-cranioplasty seizures. Further studies are warranted to investigate whether early surgery after craniectomy can reduce the risk of early post-cranioplasty seizures 5).


A retrospective study, covering the period between January 2008 and July 2015, compared postcranioplasty seizures (PCS) in postcranioplasty patients. Postcranioplasty seizures risk factors included diabetes mellitus, hypertension, time between DC and cranioplasty, duraplasty material, cranioplasty contusion location, electrocautery method, PCS type, and infection. Multivariate logistic regression analysis was performed and confidence intervals (CIs) were calculated (95% CI).

Of 270 patients, 32 exhibited initial PCS onset postcranioplasty with 11.9% incidence (32/270). Patients fell into immediate (within 24 hours), early (from 1 to 7 days), and late (after 7 days) PCS groups with frequencies of 12, 5, and 15 patients, respectively. Generalized, partial, and mixed seizure types were observed in 13, 13, and 6 patients, respectively. Multivariate logistic regression analysis showed increased risk with increasing age (>50 years). Cranioplasty contusion location, precranioplasty deficits, duraplasty material, and monopolar electrocautery were predictive of PCS onset (P < 0.05). Increased DC to cranioplasty interval increased risk but was not statistically significant (P = 0.062).

Understanding risk factors for PCS will benefit the management of cranioplasty patients 6).

References

1)

L. Lee, J. Ker, B.L. Quah, N. Chou, D. Choy, T.T. Yeo, A retrospective analysis and review of an institution’s experience with the complications of cranioplasty, Br. J. Neurosurg. 27 (2013) 629e635.
2)

A. Pechmann, C. Anastasopoulos, R. Korinthenberg, V. van Velthoven-Wurster, J. Kirschner, Decompressive craniectomy after severe traumatic brain injury in children: complications and outcome, Neuropediatrics 46 (2015) 5e12.
3)

Chen F, Duan Y, Li Y, Han W, Shi W, Zhang W, Huang Y. Use of an antiepileptic drug to control epileptic seizures associated with cranioplasty: A Randomised Controlled Trial. Int J Surg. 2017 Feb 18. pii: S1743-9191(17)30140-1. doi: 10.1016/j.ijsu.2017.02.017. [Epub ahead of print] PubMed PMID: 28223259.
4)

Spencer R, Manivannan S, Sharouf F, Bhatti MI, Zaben M. Risk factors for the development of seizures after cranioplasty in patients that sustained traumatic brain injury: A systematic review. Seizure. 2019 Mar 21;69:11-16. doi: 10.1016/j.seizure.2019.03.014. [Epub ahead of print] Review. PubMed PMID: 30952091.
5)

Shih FY, Lin CC, Wang HC, Ho JT, Lin CH, Lu YT, Chen WF, Tsai MH. Risk factors for seizures after cranioplasty. Seizure. 2019 Mar;66:15-21. doi: 10.1016/j.seizure.2018.12.016. Epub 2018 Dec 19. PubMed PMID: 30772643.
6)

Wang H, Zhang K, Cao H, Zhang X, Li Y, Wei Q, Zhang D, Jia Q, Bie L. Seizure After Cranioplasty: Incidence and Risk Factors. J Craniofac Surg. 2017 Sep;28(6):e560-e564. doi: 10.1097/SCS.0000000000003863. PubMed PMID: 28796104.

Cranioplasty materials

Cranioplasty materials

Available evidence on the safety of cranioplasty materials is limited due to a large diversity in study conduct, patients included and outcomes reported. Autologous bone grafts appear to carry a higher failure risk than allografts. Future publications concerning cranioplasties will benefit by a standardized reporting of surgical procedures, outcomes and graft materials used 1).

A literature review in 2016 emphasizes the benefits and weaknesses of each considered material commonly used for cranioplasty, especially in terms of infectious complications, fractures, and morphological outcomes.As regards the latter, this appears to be very similar among the different materials when custom three-dimensional modeling is used for implant development, suggesting that this criterion is strongly influenced by implant design. However, the overall infection rate can vary from 0% to 30%, apparently dependent on the type of material used, likely in virtue of the wide variation in their chemico-physical composition. Among the different materials used for cranioplasty implants, synthetics such as polyetheretherketonepolymethylmethacrylate, and titanium show a higher primary tear resistance, whereas hydroxyapatite and autologous bone display good biomimetic properties, although the latter has been ascribed a variable reabsorption rate of between 3% and 50%. In short, all cranioplasty procedures and materials have their advantages and disadvantages, and none of the currently available materials meet the criteria required for an ideal implant. Hence, the choice of cranioplasty materials is still essentially reliant on the surgeon’s preference 2).


In 19th century, the use of bone from different donor sites, such as ribs or tibia, gained wide population.

Many different types of materials were used throughout the history of cranioplasty. With the evolving biomedical technology, new materials are available to be used by the surgeons. Although many different materials and techniques had been described, there is still no consensus about the best material, and ongoing researches on both biologic and nonbiologic substitutions continue aiming to develop the ideal reconstruction materials.

Cranioplasty can be performed either with gold-standard, autologous bone flaps and osteotomies or alloplastic materials in skeletally mature patients. Recently, custom computer-generated implants (CCGIs) have gained popularity with surgeons because of potential advantages, which include preoperatively planned contour, obviated donor-site morbidity, and operative time savings. A remaining concern is the cost of CCGI production.

see Autologous bone flap cranioplasty

Synthetic implants

Several materials are available. Each has its advantages and disadvantages. Search is on for an ideal material.

Polymethylmethacrylate cranioplasty and polyetheretherketone (PEEK) are the most commonly applied today.

Celluloid cranioplasty

PEEK cranioplasty

Fiberglass cranioplasty

Polypropylene polyester knitwear

Tantalum cranioplasty

Titanium cranioplasty

Acrylic bone cement


An experimental model was developed in an indoor gun range. CAD cranioplasties with a material thickness of 2-6 mm, made of titanium or PEEK-OPTIMA(®) were fixed in a watermelon and shot at with a .222 Remington rifle at a distance of 30 m distance, a .30-06 Springfield rifle at a distance of 30 m, a Luger 9 mm pistol at a distance of 8 m, or a .375 Magnum revolver at a distance of 8 m. The CAD cranioplasties were subsequently inspected for ballistic effects by a neurosurgeon.

Titanium CAD cranioplasty implants resisted shots from the 9 mm Luger pistol and were penetrated by both the .222 Remington and the .30-06 Springfield rifle. Shooting with the .357 Magnum revolver resulted in the titanium implant bursting. PEEK-OPTIMA(®) implants did not resist bullets shot from any weapon. The implants burst on shooting with the 9 mm Luger pistol, the .222 Remington, the .30-06 Springfield rifle, and the .357 Magnum revolver.

Titanium CAD cranioplasty implants may offer protection from ballistic injuries caused by small caliber weapons fired at short distances. This could provide a life-saving advantage in civilian as well as military combat situations 3).


Methylmethacrylate and porous polyethylene (PP) were resistant to fracture and disruption. MMA provided the greatest neuroprotection, followed by PP. Autologous bone provided the least protection with cranioplasty disruption and severe brain injury occurring in every patient. Brain injury patterns correlated with the degree of cranioplasty disruption regardless of the cranioplasty material. Regardless of the energy of impact, lack of dislodgement generally resulted in no obvious brain injury 4).

Sonolucent cranioplasty

References

1)

van de Vijfeijken SECM, Münker TJAG, Spijker R, Karssemakers LHE, Vandertop WP, Becking AG, Ubbink DT; CranioSafe Group. Autologous bone is inferior to alloplastic cranioplasties Safety of autograft and allograft materials for cranioplasties, a systematic review. World Neurosurg. 2018 Jun 4. pii: S1878-8750(18)31147-1. doi: 10.1016/j.wneu.2018.05.193. [Epub ahead of print] Review. PubMed PMID: 29879511.
2)

Zanotti B, Zingaretti N, Verlicchi A, Robiony M, Alfieri A, Parodi PC. Cranioplasty: Review of Materials. J Craniofac Surg. 2016 Aug 19. [Epub ahead of print] PubMed PMID: 27548829.
3)

Lemcke J, Löser R, Telm A, Meier U. Ballistics for neurosurgeons: Effects of firearms of customized cranioplasty implants. Surg Neurol Int. 2013 Apr 3;4:46. doi: 10.4103/2152-7806.110027. Print 2013. PubMed PMID: 23607068; PubMed Central PMCID: PMC3622352.
4)

Wallace RD, Salt C, Konofaos P. Comparison of Autogenous and Alloplastic Cranioplasty Materials Following Impact Testing. J Craniofac Surg. 2015 Jul;26(5):1551-7. doi: 10.1097/SCS.0000000000001882. PubMed PMID: 26114508.
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