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  • 1
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    Research protocol: Cervical Arthroplasty Cost Effectiveness Study (CACES): economic evaluation of anterior cervical discectomy with arthroplasty (ACDA) versus anterior cervical discectomy with fusion (ACDF) in the surgical treatment of cervical degenerative disc disease — a randomized controlled trial
    Springer Science and Business Media LLC ; 2022
    In:  Trials Vol. 23, No. 1 ( 2022-08-26)
    Details
    In: Trials, Springer Science and Business Media LLC, Vol. 23, No. 1 ( 2022-08-26)
    Abstract: To date, there is no consensus on which anterior surgical technique is more cost-effective in treating cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multi-level symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and/or myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). The extent to which kinematics, surgery-induced fusion, natural history, and progression of disease play a role in the development of CASP remains unclear. Anterior cervical discectomy with arthroplasty (ACDA) is another treatment option that is thought to reduce the incidence of CASP by preserving motion in the operated segment. While ACDA is often discouraged, as the implant costs are higher while the clinical outcomes are similar to ACDF, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long term. Methods and analysis In this randomized controlled trial, patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and/or myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a healthcare and societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months until 4 years post-surgery. Discussion High-quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking; to date, there are no prospective trials from a societal perspective. Considering the aging of the population and the rising healthcare costs, there is an urgent need for a solid clinical cost-effectiveness trial addressing this question. Trial registration ClinicalTrials.gov NCT04623593. Registered on 29 September 2020.
    Type of Medium: Online Resource
    ISSN: 1745-6215
    URL: Article
    DOI: 10.1186/s13063-022-06574-5
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2040523-6
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  • 2
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    Advocating uniformity in spine surgery: a practical disease-specific guideline for trial-based economic evaluations
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 7 ( 2023-07), p. e073535-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 7 ( 2023-07), p. e073535-
    Abstract: Despite the availability of general and national guidelines for the conduct and reporting of economic evaluations, there is heterogeneity in economic evolutions concerning spine surgery. This is partly the result of differing levels of adherence to the existing guidelines and the lack of disease-specific recommendations for economic evaluations. The extensive heterogeneity in study design, follow-up duration and outcome measurements limit the comparability of economic evaluations in spine surgery. This study has three objectives: (1) to create disease-specific recommendations for the design and conduct of trial-based economic evaluations in spine surgery, (2) to define recommendations for reporting economic evaluations in spine surgery as a complement to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 checklist and (3) to discuss methodological challenges and defining the need for future research. Design A modified Delphi method according to the RAND/UCLA Appropriateness Method. Setting A four-step process was followed to create and validate disease-specific statements and recommendations for the conduct and reporting of trial-based economic evaluations in spine surgery. Consensus was defined as 〉 75% agreement. Participants A total of 20 experts were included in the expert group. Validation of the final recommendations was obtained in a Delphi panel, which consisted of 40 researchers in the field who were not included in the expert group. Primary and secondary outcome measures The primary outcome measure is a set of recommendations for the conduct and reporting, as a complement to the CHEERS 2022 checklist, of economic evaluations in spine surgery. Results A total of 31 recommendations are made. The Delphi panel confirmed consensus on all of the recommendations in the proposed guideline. Conclusion This study provides an accessible and practical guideline for the conduct of trial-based economic evaluations in spine surgery. This disease-specific guideline is a complement to existing guidelines, and should aid in reaching uniformity and comparability.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2023-073535
    DOI: 10.1136/bmjopen-2023-073535.supp2
    DOI: 10.1136/bmjopen-2023-073535.supp3
    DOI: 10.1136/bmjopen-2023-073535.supp4
    DOI: 10.1136/bmjopen-2023-073535.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2599832-8
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  • 3
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    Evidence-based recommendations for economic evaluations in spine surgery: study protocol for a Delphi consensus
    BMJ ; 2021
    In:  BMJ Open Vol. 11, No. 12 ( 2021-12), p. e052988-
    Details
    In: BMJ Open, BMJ, Vol. 11, No. 12 ( 2021-12), p. e052988-
    Abstract: Considering the rising global healthcare expenses, economic evaluations are more important than ever. Even though the number of studies regarding costs and cost-effectiveness is increasing, the quality of these studies remains relatively low. This is mainly caused by abundant heterogeneity in methods used for determining, calculating and reporting cost data, despite current general guidelines for the conduct of economic evaluations. Disease-specific recommendations for the conduct of economic evaluations in the field of spine surgery, as complement to existing general guidelines, will ameliorate overall research quality, comparability and interpretability and thus, the overall quality. We aim to provide expert-based recommendations for the design, conduct, and reporting of economic evaluations in spine surgery. Methods and analysis A modified Delphi study will be conducted to formulate expert-based recommendations. The following steps will be taken: (1) The conduct of a systematic review to identify relevant publications and identify relevant authors. Formation of an expert group and a Delphi-panel. (2) Drafting of statements based on articles included in the systematic literature review. Validation of drafted statements by the expert group. Step 2 can be repeated up to three times, statements can be discarded and adjusted in these rounds. Statements with more than 75% agreement will be accepted as consensus statements. (3) Validation of statements by the Delphi-panel. (4) Final recommendations. Ethics and dissemination The underlying work is based on existing literature and published data and does not include participation of patients, and thus does not require ethical review approval. The final recommendations are intended for (clinical) researchers in the field of cost-effectiveness in spine surgery. The Delphi method ensures that the final output reflects the opinions of international participants and gives insight in the adherence level to the recommendations. The aim is to reach uniformity in design, conduct and reporting of these studies, as is currently lacking. This will provide a solid basis to determine cost-effectiveness of spine surgeries and consequently aid to limit the rising healthcare costs. The findings of this study and the final recommendations will be disseminated in conferences and seminars and will be published in an international peer-reviewed journal.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2021-052988
    DOI: 10.1136/bmjopen-2021-052988.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2599832-8
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  • 4
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    Methodology of economic evaluations in spine surgery: a systematic review and qualitative assessment
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 3 ( 2023-03), p. e067871-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 3 ( 2023-03), p. e067871-
    Abstract: The present study is a systematic review conducted as part of a methodological approach to develop evidence-based recommendations for economic evaluations in spine surgery. The aim of this systematic review is to evaluate the methodology and quality of currently available clinical cost-effectiveness studies in spine surgery. Study design Systematic literature review. Data sources PubMed, Web of Science, Embase, Cochrane, Cumulative Index to Nursing and Allied Health Literature, EconLit and The National Institute for Health Research Economic Evaluation Database were searched through 8 December 2022. Eligibility criteria for selecting studies Studies were included if they met all of the following eligibility criteria: (1) spine surgery, (2) the study cost-effectiveness and (3) clinical study. Model-based studies were excluded. Data extraction and synthesis The following data items were extracted and evaluated: pathology, number of participants, intervention(s), year, country, study design, time horizon, comparator(s), utility measurement, effectivity measurement, costs measured, perspective, main result and study quality. Results 130 economic evaluations were included. Seventy-four of these studies were retrospective studies. The majority of the studies had a time horizon shorter than 2 years. Utility measures varied between the EuroQol 5 dimensions and variations of the Short-Form Health Survey. Effect measures varied widely between Visual Analogue Scale for pain, Neck Disability Index, Oswestry Disability Index, reoperation rates and adverse events. All studies included direct costs from a healthcare perspective. Indirect costs were included in 47 studies. Total Consensus Health Economic Criteria scores ranged from 2 to 18, with a mean score of 12.0 over all 130 studies. Conclusions The comparability of economic evaluations in spine surgery is extremely low due to different study designs, follow-up duration and outcome measurements such as utility, effectiveness and costs. This illustrates the need for uniformity in conducting and reporting economic evaluations in spine surgery.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2022-067871
    DOI: 10.1136/bmjopen-2022-067871.supp1
    DOI: 10.1136/bmjopen-2022-067871.supp2
    DOI: 10.1136/bmjopen-2022-067871.supp3
    DOI: 10.1136/bmjopen-2022-067871.supp4
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2599832-8
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  • 5
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    Low-Threshold-For-Surgery Versus Primarily-Conservative Treatment for Odontoid Fractures in the Elderly: Evaluating Practice Variation in The Netherlands
    SAGE Publications ; 2023
    In:  Global Spine Journal
    Details
    In: Global Spine Journal, SAGE Publications
    Abstract: Retrospective cohort study. Objectives Odontoid fractures are the most common cervical spine fractures in the elderly. The optimal treatment remains controversial. The aim of this study was to compare results of a low-threshold-for-surgery strategy (surgery for dislocated fractures in relatively healthy patients) to a primarily-conservative strategy (for all patients). Methods Patient records from 5 medical centers were reviewed for patients who met the selection criteria (e.g. age ≥55 years, type II/III odontoid fractures). Demographics, fracture types/characteristics, fracture union/stability, clinical outcome and mortality were compared. The influence of age on outcome was studied (≥55-80 vs ≥80 years). Results A total of 173 patients were included: 120 treated with low-threshold-for-surgery (of which 22 primarily operated, and 23 secondarily) vs 53 treated primarily-conservative. No differences in demographics and fracture characteristics between the groups were identified. Fracture union (53% vs 43%) and fracture stability (90% vs 85%) at last follow-up did not differ between groups. The majority of patients (56%) achieved clinical improvement compared to baseline. Analysis of differences in clinical outcome between groups was infeasible due to data limitations. In both strategies, patients ≥80 years achieved worse union (64% vs 30%), worse stability (97% vs 77%), and – as to be expected – increased mortality 〈 104 weeks (2% vs 22%). Conclusions Union and stability rates did not differ between the treatment strategies. Advanced age (≥80 years) negatively influenced both radiological outcome and mortality. No cases of secondary neurological deficits were identified, suggesting that concerns for the consequences of under-treatment may be unjustified.
    Type of Medium: Online Resource
    ISSN: 2192-5682 , 2192-5690
    URL: Article
    DOI: 10.1177/21925682231194818
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2648287-3
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  • 6
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    Ethics of Deep Brain Stimulation in Adolescent Patients with Refractory Tourette Syndrome: a Systematic Review and Two Case Discussions
    Springer Science and Business Media LLC ; 2018
    In:  Neuroethics Vol. 11, No. 2 ( 2018-7), p. 143-155
    Details
    In: Neuroethics, Springer Science and Business Media LLC, Vol. 11, No. 2 ( 2018-7), p. 143-155
    Type of Medium: Online Resource
    ISSN: 1874-5490 , 1874-5504
    URL: Article
    DOI: 10.1007/s12152-018-9359-6
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2018
    detail.hit.zdb_id: 2421622-7
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  • 7
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    Ossification of the posterior longitudinal ligament at the craniocervical junction presenting with Brown-Séquard syndrome: A case report
    Scientific Scholar ; 2021
    In:  Surgical Neurology International Vol. 12 ( 2021-10-06), p. 501-
    Details
    In: Surgical Neurology International, Scientific Scholar, Vol. 12 ( 2021-10-06), p. 501-
    Abstract: Several case reports about spinal cord compression due to hyperostosis at the craniocervical junction are available. However, compression at C1-C2 solely due to ossification of the posterior longitudinal ligament (OPLL) is rare. Case Description: A 50-year-old Asian male, with a history of lumbar spinal canal stenosis, presented with a progressive quadriparesis within 3 months. Imaging showed central OPLL at the C1-C2 level contributing to severe spinal cord compression. The patient improved neurologically after a C1-C2 laminectomy. Conclusion: A patient presented with a progressive Brown-Séquard syndrome due to OPLL at the craniocervical junction (C1-C2 level) and improved following a decompressive laminectomy.
    Type of Medium: Online Resource
    ISSN: 2152-7806
    URL: Article
    DOI: 10.25259/SNI_704_2021
    Language: English
    Publisher: Scientific Scholar
    Publication Date: 2021
    detail.hit.zdb_id: 2567759-7
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