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1.
N Engl J Med ; 388(24): 2219-2229, 2023 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-37092792

RESUMO

BACKGROUND: Traumatic acute subdural hematomas frequently warrant surgical evacuation by means of a craniotomy (bone flap replaced) or decompressive craniectomy (bone flap not replaced). Craniectomy may prevent intracranial hypertension, but whether it is associated with better outcomes is unclear. METHODS: We conducted a trial in which patients undergoing surgery for traumatic acute subdural hematoma were randomly assigned to undergo craniotomy or decompressive craniectomy. An inclusion criterion was a bone flap with an anteroposterior diameter of 11 cm or more. The primary outcome was the rating on the Extended Glasgow Outcome Scale (GOSE) (an 8-point scale, ranging from death to "upper good recovery" [no injury-related problems]) at 12 months. Secondary outcomes included the GOSE rating at 6 months and quality of life as assessed by the EuroQol Group 5-Dimension 5-Level questionnaire (EQ-5D-5L). RESULTS: A total of 228 patients were assigned to the craniotomy group and 222 to the decompressive craniectomy group. The median diameter of the bone flap was 13 cm (interquartile range, 12 to 14) in both groups. The common odds ratio for the differences across GOSE ratings at 12 months was 0.85 (95% confidence interval, 0.60 to 1.18; P = 0.32). Results were similar at 6 months. At 12 months, death had occurred in 30.2% of the patients in the craniotomy group and in 32.2% of those in the craniectomy group; a vegetative state occurred in 2.3% and 2.8%, respectively, and a lower or upper good recovery occurred in 25.6% and 19.9%. EQ-5D-5L scores were similar in the two groups at 12 months. Additional cranial surgery within 2 weeks after randomization was performed in 14.6% of the craniotomy group and in 6.9% of the craniectomy group. Wound complications occurred in 3.9% of the craniotomy group and in 12.2% of the craniectomy group. CONCLUSIONS: Among patients with traumatic acute subdural hematoma who underwent craniotomy or decompressive craniectomy, disability and quality-of-life outcomes were similar with the two approaches. Additional surgery was performed in a higher proportion of the craniotomy group, but more wound complications occurred in the craniectomy group. (Funded by the National Institute for Health and Care Research; RESCUE-ASDH ISRCTN Registry number, ISRCTN87370545.).


Assuntos
Craniotomia , Craniectomia Descompressiva , Hematoma Subdural Agudo , Humanos , Craniotomia/efeitos adversos , Craniotomia/métodos , Craniectomia Descompressiva/efeitos adversos , Craniectomia Descompressiva/métodos , Escala de Resultado de Glasgow , Hematoma Subdural Agudo/cirurgia , Qualidade de Vida , Estudos Retrospectivos , Crânio/cirurgia , Resultado do Tratamento , Retalhos Cirúrgicos/cirurgia
2.
Neurosurg Rev ; 47(1): 363, 2024 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-39060778

RESUMO

The importance of social media has seen a dramatic increase in recent times, but much about its influence in academia is still unknown. To date, no comparative studies analysing the effect of social media promotion on citation counts have been undertaken in neurosurgical publishing. We randomized 177 articles published in Acta Neurochirurgica from May to September 2020. The 89 articles in the intervention group received a standardized social media promotion through one post on our official Twitter/X account, whereas the 88 articles in the control group did not receive any social media promotion. Citation counts, website visits and PDF downloads were tracked at one and two years post-promotion. We found no significant difference in number of citations at one year post-promotion (Intervention: 1.85 ± 3.94 vs. Control: 2.67 ± 6.65, p = 0.322) or at two years (5.35 ± 7.39 vs. 7.09 ± 12.1, p = 0.249). Similarly, no difference was detected in website visits at one (587.46 ± 568.04 vs. 590.65 ± 636.25, p = 0.972) or two years (865.79 ± 855.80 vs. 896.31 ± 981.97, p = 0.826) and PDF downloads at one (183.40 ± 152.02 vs. 187.78 ± 199.01, p = 0.870) or two years (255.99 ± 218.97 vs. 260.97 ± 258.44, p = 0.890). In a randomized study, a structured promotion of general neurosurgical articles on Twitter/X did not significantly impact citation count, website visits, or PDF downloads compared to no social media promotion. Combined with published evidence to date, the impact of social media on citation counts in academic publishing ultimately remains unclear.


Assuntos
Neurocirurgia , Editoração , Mídias Sociais , Humanos , Publicações Periódicas como Assunto
3.
Acta Neurochir (Wien) ; 166(1): 250, 2024 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-38833024

RESUMO

INTRODUCTION: Systematic reviews (SRs) and meta-analyses (MAs) are methods of data analysis used to synthesize information presented in multiple publications on the same topic. A thorough understanding of the steps involved in conducting this type of research and approaches to data analysis is critical for appropriate understanding, interpretation, and application of the findings of these reviews. METHODS: We reviewed reference texts in clinical neuroepidemiology, neurostatistics and research methods and other previously related articles on meta-analyses (MAs) in surgery. Based on existing theories and models and our cumulative years of expertise in conducting MAs, we have synthesized and presented a detailed pragmatic approach to interpreting MAs in Neurosurgery. RESULTS: Herein we have briefly defined SRs sand MAs and related terminologies, succinctly outlined the essential steps to conduct and critically appraise SRs and MAs. A practical approach to interpreting MAs for neurosurgeons is described in details. Based on summary outcome measures, we have used hypothetical examples to illustrate the Interpretation of the three commonest types of MAs in neurosurgery: MAs of Binary Outcome Measures (Pairwise MAs), MAs of proportions and MAs of Continuous Variables. Furthermore, we have elucidated on the concepts of heterogeneity, modeling, certainty, and bias essential for the robust and transparent interpretation of MAs. The basics for the Interpretation of Forest plots, the preferred graphical display of data in MAs are summarized. Additionally, a condensation of the assessment of the overall quality of methodology and reporting of MA and the applicability of evidence to patient care is presented. CONCLUSION: There is a paucity of pragmatic guides to appraise MAs for surgeons who are non-statisticians. This article serves as a detailed guide for the interpretation of systematic reviews and meta-analyses with examples of applications for clinical neurosurgeons.


Assuntos
Metanálise como Assunto , Neurocirurgia , Procedimentos Neurocirúrgicos , Humanos , Procedimentos Neurocirúrgicos/métodos , Revisões Sistemáticas como Assunto/métodos , Interpretação Estatística de Dados
4.
Neurocrit Care ; 2024 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-38811514

RESUMO

BACKGROUND: Numerous trials have addressed intracranial pressure (ICP) management in neurocritical care. However, identifying its harmful thresholds and controlling ICP remain challenging in terms of improving outcomes. Evidence suggests that an individualized approach is necessary for establishing tolerance limits for ICP, incorporating factors such as ICP waveform (ICPW) or pulse morphology along with additional data provided by other invasive (e.g., brain oximetry) and noninvasive monitoring (NIM) methods (e.g., transcranial Doppler, optic nerve sheath diameter ultrasound, and pupillometry). This study aims to assess current ICP monitoring practices among experienced clinicians and explore whether guidelines should incorporate ancillary parameters from NIM and ICPW in future updates. METHODS: We conducted a survey among experienced professionals involved in researching and managing patients with severe injury across low-middle-income countries (LMICs) and high-income countries (HICs). We sought their insights on ICP monitoring, particularly focusing on the impact of NIM and ICPW in various clinical scenarios. RESULTS: From October to December 2023, 109 professionals from the Americas and Europe participated in the survey, evenly distributed between LMIC and HIC. When ICP ranged from 22 to 25 mm Hg, 62.3% of respondents were open to considering additional information, such as ICPW and other monitoring techniques, before adjusting therapy intensity levels. Moreover, 77% of respondents were inclined to reassess patients with ICP in the 18-22 mm Hg range, potentially escalating therapy intensity levels with the support of ICPW and NIM. Differences emerged between LMIC and HIC participants, with more LMIC respondents preferring arterial blood pressure transducer leveling at the heart and endorsing the use of NIM techniques and ICPW as ancillary information. CONCLUSIONS: Experienced clinicians tend to personalize ICP management, emphasizing the importance of considering various monitoring techniques. ICPW and noninvasive techniques, particularly in LMIC settings, warrant further exploration and could potentially enhance individualized patient care. The study suggests updating guidelines to include these additional components for a more personalized approach to ICP management.

5.
Emerg Med J ; 41(7): 409-414, 2024 Jun 20.
Artigo em Inglês | MEDLINE | ID: mdl-38388191

RESUMO

BACKGROUND: Trauma accounts for a huge burden of disease worldwide. Trauma systems have been implemented in multiple countries across the globe, aiming to link and optimise multiple aspects of the trauma care pathway, and while they have been shown to reduce overall mortality, much less is known about their cost-effectiveness and impact on morbidity. METHODS: We performed a systematic review to explore the impact the implementation of a trauma system has on morbidity, quality of life and economic outcomes, in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All comparator study types published since 2000 were included, both retrospective and prospective in nature, and no limits were placed on language. Data were reported as a narrative review. RESULTS: Seven articles were identified that met the inclusion criteria, all of which reported a pre-trauma and post-trauma system implementation comparison in high-income settings. The overall study quality was poor, with all studies demonstrating a severe risk of bias. Five studies reported across multiple types of trauma patients, the majority describing a positive impact across a variety of morbidity and health economic outcomes following trauma system implementation. Two studies focused specifically on traumatic brain injury and did not demonstrate any impact on morbidity outcomes. DISCUSSION: There is currently limited and poor quality evidence that assesses the impact that trauma systems have on morbidity, quality of life and economic outcomes. While trauma systems have a fundamental role to play in high-quality trauma care, morbidity and disability data can have large economic and cultural consequences, even if mortality rates have improved. The sociocultural and political context of the surrounding healthcare infrastructure must be better understood before implementing any trauma system, particularly in resource-poor and fragile settings. PROSPERO REGISTRATION NUMBER: CRD42022348529 LEVEL OF EVIDENCE: Level III.


Assuntos
Ferimentos e Lesões , Humanos , Ferimentos e Lesões/economia , Morbidade/tendências , Qualidade de Vida , Análise Custo-Benefício , Centros de Traumatologia/organização & administração , Centros de Traumatologia/economia
6.
N Engl J Med ; 383(27): 2616-2627, 2020 12 31.
Artigo em Inglês | MEDLINE | ID: mdl-33326713

RESUMO

BACKGROUND: Chronic subdural hematoma is a common neurologic disorder that is especially prevalent among older people. The effect of dexamethasone on outcomes in patients with chronic subdural hematoma has not been well studied. METHODS: We conducted a multicenter, randomized trial in the United Kingdom that enrolled adult patients with symptomatic chronic subdural hematoma. The patients were assigned in a 1:1 ratio to receive a 2-week tapering course of oral dexamethasone, starting at 8 mg twice daily, or placebo. The decision to surgically evacuate the hematoma was made by the treating clinician. The primary outcome was a score of 0 to 3, representing a favorable outcome, on the modified Rankin scale at 6 months after randomization; scores range from 0 (no symptoms) to 6 (death). RESULTS: From August 2015 through November 2019, a total of 748 patients were included in the trial after randomization - 375 were assigned to the dexamethasone group and 373 to the placebo group. The mean age of the patients was 74 years, and 94% underwent surgery to evacuate their hematomas during the index admission; 60% in both groups had a score of 1 to 3 on the modified Rankin scale at admission. In a modified intention-to-treat analysis that excluded the patients who withdrew consent for participation in the trial or who were lost to follow-up, leaving a total of 680 patients, a favorable outcome was reported in 286 of 341 patients (83.9%) in the dexamethasone group and in 306 of 339 patients (90.3%) in the placebo group (difference, -6.4 percentage points [95% confidence interval, -11.4 to -1.4] in favor of the placebo group; P = 0.01). Among the patients with available data, repeat surgery for recurrence of the hematoma was performed in 6 of 349 patients (1.7%) in the dexamethasone group and in 25 of 350 patients (7.1%) in the placebo group. More adverse events occurred in the dexamethasone group than in the placebo group. CONCLUSIONS: Among adults with symptomatic chronic subdural hematoma, most of whom had undergone surgery to remove their hematomas during the index admission, treatment with dexamethasone resulted in fewer favorable outcomes and more adverse events than placebo at 6 months, but fewer repeat operations were performed in the dexamethasone group. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Dex-CSDH ISRCTN number, ISRCTN80782810.).


Assuntos
Dexametasona/uso terapêutico , Glucocorticoides/uso terapêutico , Hematoma Subdural Crônico/tratamento farmacológico , Administração Oral , Idoso , Terapia Combinada , Dexametasona/administração & dosagem , Dexametasona/efeitos adversos , Pessoas com Deficiência , Feminino , Glucocorticoides/administração & dosagem , Glucocorticoides/efeitos adversos , Hematoma Subdural Crônico/complicações , Hematoma Subdural Crônico/mortalidade , Hematoma Subdural Crônico/cirurgia , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Reoperação/estatística & dados numéricos , Índice de Gravidade de Doença , Resultado do Tratamento
7.
Pituitary ; 26(6): 645-652, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37843726

RESUMO

PURPOSE: Heterogeneous reporting in baseline variables in patients undergoing transsphenoidal resection of pituitary adenoma precludes meaningful meta-analysis. We therefore examined trends in reported baseline variables, and degree of heterogeneity of reported variables in 30 years of literature. METHODS: A systematic review of PubMed and Embase was conducted on studies that reported outcomes for transsphenoidal surgery for pituitary adenoma 1990-2021. The protocol was registered a priori and adhered to the PRISMA statement. Full-text studies in English with > 10 patients (prospective), > 500 patients (retrospective), or randomised trials were included. RESULTS: 178 studies were included, comprising 427,659 patients: 52 retrospective (29%); 118 prospective (66%); 9 randomised controlled trials (5%). The majority of studies were published in the last 10 years (71%) and originated from North America (38%). Most studies described patient demographics, such as age (165 studies, 93%) and sex (164 studies, 92%). Ethnicity (24%) and co-morbidities (25%) were less frequently reported. Clinical baseline variables included endocrine (60%), ophthalmic (34%), nasal (7%), and cognitive (5%). Preoperative radiological variables were described in 132 studies (74%). MRI alone was the most utilised imaging modality (67%). Further specific radiological baseline variables included: tumour diameter (52 studies, 39%); tumour volume (28 studies, 21%); cavernous sinus invasion (53 studies, 40%); Wilson Hardy grade (25 studies, 19%); Knosp grade (36 studies, 27%). CONCLUSIONS: There is heterogeneity in the reporting of baseline variables in patients undergoing transsphenoidal surgery for pituitary adenoma. This review supports the need to develop a common data element to facilitate meaningful comparative research, trial design, and reduce research inefficiency.


Assuntos
Adenoma , Neoplasias Hipofisárias , Humanos , Adenoma/cirurgia , Adenoma/patologia , Neoplasias Hipofisárias/cirurgia , Neoplasias Hipofisárias/patologia , Estudos Prospectivos , Estudos Retrospectivos , Resultado do Tratamento
8.
Pituitary ; 26(2): 171-181, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36862265

RESUMO

PURPOSE: Transsphenoidal surgery is an established treatment for pituitary adenomas. We examined outcomes and time points following transsphenoidal surgery for pituitary adenoma to identify reporting heterogeneity within the literature. METHODS: A systematic review of studies that reported outcomes for transsphenoidal surgery for pituitary adenoma 1990-2021 were examined. The protocol was registered a priori and adhered to the PRISMA statement. Studies in English with > 10 patients (prospective) or > 500 patients (retrospective) were included. RESULTS: 178 studies comprising 427,659 patients were included. 91 studies reported 2 or more adenoma pathologies within the same study; 53 studies reported a single pathology. The most common adenomas reported were growth hormone-secreting (n = 106), non-functioning (n = 101), and ACTH-secreting (n = 95); 27 studies did not state a pathology. Surgical complications were the most reported outcome (n = 116, 65%). Other domains included endocrine (n = 104, 58%), extent of resection (n = 81, 46%), ophthalmic (n = 66, 37%), recurrence (n = 49, 28%), quality of life (n = 25, 19%); and nasal (n = 18, 10%). Defined follow up time points were most reported for endocrine (n = 56, 31%), extent of resection (n = 39, 22%), and recurrence (n = 28, 17%). There was heterogeneity in the follow up reported for all outcomes at different time points: discharge (n = 9), < 30 days (n = 23), < 6 months (n = 64), < 1 year (n = 23), and > 1 year (n = 69). CONCLUSION: Outcomes and follow up reported for transsphenoidal surgical resection of pituitary adenoma are heterogenous over the last 30 years. This study highlights the necessity to develop a robust, consensus-based, minimum, core outcome set. The next step is to develop a Delphi survey of essential outcomes, followed by a consensus meeting of interdisciplinary experts. Patient representatives should also be included. An agreed core outcome set will enable homogeneous reporting and meaningful research synthesis, ultimately improving patient care.


Assuntos
Adenoma , Neoplasias Hipofisárias , Humanos , Neoplasias Hipofisárias/cirurgia , Neoplasias Hipofisárias/patologia , Estudos Retrospectivos , Estudos Prospectivos , Qualidade de Vida , Resultado do Tratamento , Adenoma/cirurgia , Adenoma/patologia , Medidas de Resultados Relatados pelo Paciente
9.
Acta Neurochir (Wien) ; 165(12): 3573-3581, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37843607

RESUMO

BACKGROUND: Social media (SoMe) use, in all of its forms, has seen massively increased throughout the past two decades, including academic publishing. Many journals have established a SoMe presence, yet the influence of promotion of scientific publications on their visibility and impact remains poorly studied. The European Journal of Neurosurgery «Acta Neurochirurgica¼ has established its SoMe presence in form of a Twitter account that regularly promotes its publications. We aim to analyze the impact of this initial SoMe campaign on various alternative metrics (altmetrics). METHODS: A retrospective analysis of all articles published in the journal Acta Neurochirurgica between May 1st, 2018, and April 30th, 2020, was performed. These articles were divided into a historical control group - containing the articles published between May 1st, 2018, and April 30th, 2019, when the SoMe campaign was not yet established - and into an intervention group. Several altmetrics were analyzed, along with website visits and PDF downloads per month. RESULTS: In total, 784 articles published during the study period, 128 (16.3%) were promoted via Twitter. During the promotion period, 29.7% of published articles were promoted. Overall, the published articles reached a mean of 31.3 ± 50.5 website visits and 17.5 ± 31.25 PDF downloads per month. Comparing the two study periods, no statistically significant differences in website visits (26.91 ± 32.87 vs. 34.90 ± 61.08, p = 0.189) and PDF downloads (17.52 ± 31.25 vs. 15.33 ± 16.07, p = 0.276) were detected. However, overall compared to non-promoted articles, promoted articles were visited (48.9 ± 95.0 vs. 29.0 ± 37.0, p = 0.005) and downloaded significantly more (25.7 ± 66.7 vs. 16.6 ± 18.0, p = 0.045) when compared to those who were not promoted during the promotion period. CONCLUSIONS: We report a 1-year initial experience with promotion of a general neurosurgical journal on Twitter. Our data suggest a clear benefit of promotion on article site visits and article downloads, although no single responsible element could be determined in terms of altmetrics. The impact of SoMe promotion on other metrics, including traditional bibliometrics such as citations and journal impact factor, remains to be determined.


Assuntos
Mídias Sociais , Humanos , Estudos Retrospectivos , Bibliometria , Fator de Impacto de Revistas , Publicações
10.
Acta Neurochir (Wien) ; 165(11): 3217-3227, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37747570

RESUMO

PURPOSE: Evidence regarding the effect of surgery in traumatic intracerebral hematoma (t-ICH) is limited and relies on the STITCH(Trauma) trial. This study is aimed at comparing the effectiveness of early surgery to conservative treatment in patients with a t-ICH. METHODS: In a prospective cohort, we included patients with a large t-ICH (< 48 h of injury). Primary outcome was the Glasgow Outcome Scale Extended (GOSE) at 6 months, analyzed with multivariable proportional odds logistic regression. Subgroups included injury severity and isolated vs. non-isolated t-ICH. RESULTS: A total of 367 patients with a large t-ICH were included, of whom 160 received early surgery and 207 received conservative treatment. Patients receiving early surgery were younger (median age 54 vs. 58 years) and more severely injured (median Glasgow Coma Scale 7 vs. 10) compared to those treated conservatively. In the overall cohort, early surgery was not associated with better functional outcome (adjusted odds ratio (AOR) 1.1, (95% CI, 0.6-1.7)) compared to conservative treatment. Early surgery was associated with better outcome for patients with moderate TBI and isolated t-ICH (AOR 1.5 (95% CI, 1.1-2.0); P value for interaction 0.71, and AOR 1.8 (95% CI, 1.3-2.5); P value for interaction 0.004). Conversely, in mild TBI and those with a smaller t-ICH (< 33 cc), conservative treatment was associated with better outcome (AOR 0.6 (95% CI, 0.4-0.9); P value for interaction 0.71, and AOR 0.8 (95% CI, 0.5-1.0); P value for interaction 0.32). CONCLUSIONS: Early surgery in t-ICH might benefit those with moderate TBI and isolated t-ICH, comparable with results of the STITCH(Trauma) trial.


Assuntos
Tratamento Conservador , Hemorragia Intracraniana Traumática , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Escala de Coma de Glasgow , Hematoma/cirurgia , Hemorragia Cerebral/cirurgia
11.
Br J Neurosurg ; : 1-11, 2023 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-37698133

RESUMO

BACKGROUND: The increased popularity of cycling is leading to an anticipated increase in cycling-related traffic accidents and a need to better understand the demographics and epidemiology of craniospinal injuries in this vulnerable road user group. This study aims to systematically investigate and characterise cycling-related head and spine injuries seen in the Major Trauma Centre for the Eastern region, which has the highest cycling rates in the UK. METHODS: We performed a retrospective cohort study comparing the incidence, patterns, and severity of head and spine injuries in pedal cyclists presenting to the Major Trauma Centre in Cambridge between January 2012 and December 2020. Comparisons of injury patterns, characteristics, and associations were made according to mechanism of injury, helmet use, patient age and gender. RESULTS: A total of 851 patients were admitted after being involved in cycling-related collisions over the study period, with 454 (53%) sustaining head or spine injuries. The majority of victims (80%) were male and in mid-adulthood (median age 46 years). Head injuries were more common than spine injuries, with the most common head injuries being intracranial bleeds (29%), followed by skull fractures (12%), and cerebral contusions (10%). The most common spine injuries were cervical segment fractures, particularly C6 (9%), C7 (9%), and C2 (8%). Motorised collisions had a higher prevalence of spine fractures at each segment (p < 0.001) and were associated with a higher proportion of multi-vertebral fractures (p < 0.001). These collisions were also associated with impaired consciousness at the scene and more severe systemic injuries, including a lower Glasgow coma scale (R = -0.23, p < 0.001), higher injury severity score (R = 0.24, p < 0.001), and longer length of stay (R = 0.21, p < 0.001). Helmet use data showed that lack of head protection was associated with more severe injuries and poorer outcomes. CONCLUSION: As cycling rates continue to increase, healthcare providers may expect to see an increase in bicycle-related injuries in their practice. The insights gained from this study can inform the treatment of these injuries while highlighting the need for future initiatives aimed at increasing road safety and accident prevention.


Study of 851 cycling-related trauma patients in Cambridge, UK, shows high rates of head & spine injuries.Motorised collisions were associated with more severe injuries and impaired consciousness at the scene.The lack of helmet use was linked to more severe head injuries and impaired consciousness, but not to a longer hospital stay.Rising cycling rates may lead to increased incidence of these injuries in clinical practice.Our findings may be relevant for clinicians treating cycling-related traumatic injuries to head and spine.

12.
Ann Surg ; 275(1): 73-79, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-33856386

RESUMO

OBJECTIVE: To extend the IDEAL framework for device innovation, IDEAL-D, to include the preclinical stage of development (stage 0). BACKGROUND: In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety. METHODS: Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate. The group conducted a series of discussions following the principles used in the development of the original IDEAL framework. Importantly, IDEAL aims for maximal transparency, optimal validity in the evaluation of primary effects, and minimization of potential risk to patients or others. The proposals were subjected to further review and editing by members of the IDEAL Council before a final consensus version was adopted. RESULTS: In considering which studies are required before a first-in-human study, we have: (1) classified devices according to what they do and the risks they carry, (2) classified studies according to what they show about the device, and (3) made recommendations based on the principle that the more invasive and high risk a device is, the greater proof required of their safety and effectiveness before progression to clinical studies (stage 1). CONCLUSIONS: The proposed recommendations for preclinical evaluation of medical devices represent a proportionate and pragmatic approach that balances the de-risking of first-in-human translational studies against the benefits of rapid translation of new devices into clinical practice.


Assuntos
Equipamentos e Provisões , Pesquisa Translacional Biomédica , Desenho de Equipamento , Segurança de Equipamentos , Equipamentos e Provisões/classificação , Humanos , Medição de Risco
13.
Pituitary ; 25(4): 673-683, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-35838913

RESUMO

PURPOSE: Pituitary adenomas affect patients' quality-of-life (QoL) across several domains, with long-term implications even following gross-total resection or disease remission. While clinical outcomes can assess treatment efficacy, they do not capture variations in QoL. We present the development and validation of a patient reported outcome measure (PROM) for patients with pituitary adenomas undergoing transsphenoidal surgery. METHODS: The COSMIN checklist informed the development of the pituitary outcome score (POS). Consecutive patients undergoing surgical treatment for suspected pituitary adenoma at a single centre were included prospectively. An expert focus group and patient interviews informed item generation. Item reduction was conducted through exploratory factor analysis and expert consensus, followed by assessment of the tool's validity, reliability, responsiveness, and interpretability. RESULTS: 96 patients with a median age of 50 years validated the POS. The final questionnaire included 25 questions with four subscales: EQ-5D-5L-QoL, Visual Symptoms, Endocrine Symptoms and Nasal Symptoms. CONCLUSION: The POS is the first validated PROM for patients undergoing transsphenoidal surgery for a pituitary adenoma. This PROM could be integrated into contemporary practice to provide patient-centred outcomes assessment for this patient group, aligning more closely with patient objectives.


Assuntos
Adenoma , Neoplasias Hipofisárias , Adenoma/cirurgia , Humanos , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Neoplasias Hipofisárias/cirurgia , Qualidade de Vida , Reprodutibilidade dos Testes , Estudos Retrospectivos , Resultado do Tratamento
14.
Neurol Sci ; 43(1): 427-434, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33891187

RESUMO

INTRODUCTION: Chronic subdural haematoma (CSDH) is one of the most common neurosurgical pathologies. The recurrence of chronic subdural haematomas is an important concern, considering that elderly patients are the most affected and reoperations in these patients may represent a risk of neurological and clinical complications. In accordance with the inflammatory theory regarding CSDH and its recurrence, we aimed to evaluate the role of an inflammatory marker, neutrophil-to-lymphocyte ratio (NLR), as a risk factor and prognostic variable for CSDH recurrence. METHODS: We performed a cohort study of adult patients operated for post-traumatic CSDH traumatic CSDH between January 2015 and December 2019 in our neurotrauma unit, whose data was retrospectively retrieved. We excluded patients with previous inflammatory or infectious diseases as well as use of anticoagulant/antiplatelet medications. Neutrophil and lymphocyte counts were obtained 24 h preoperatively and 48-72 h postoperatively. The primary endpoint was symptomatic recurrence of CSDH up to 1 year after the surgery. An independent sample was used to validate the findings. RESULTS: The testing sample comprised 160 patients (59.4% male, mean age 69.3 ± 14.3 years, recurrence rate 22.5%). Postoperative neutrophil count and NLR were higher in those who recurred, as well as the neutrophils (median 1.15 vs 0.96, p = 0.022) and NLR (median 1.29 vs 0.79, p = 0.001) postoperative-to-preoperative ratios. Preoperative laboratory parameters or other baseline variables were not associated with recurrence. Postoperative NLR ratio (each additional unit, OR 2.53, 95% CI 1.37-4.67, p = 0.003) was independently associated with recurrence. The best cut-off for the postoperative NLR ratio was 0.995 (AUC-ROC 0.67, sensitivity 63.9%, specificity 76.6%). Postoperative NLR ratio ≥ 1 (i.e. a post-operative NLR that does not decrease compared to the preoperative value) was associated with recurrence (OR 4.59, 95% CI 2.00-10.53, p < 0.001). The validation sample analysis (66 patients) yielded similar results (AUC-ROC 0.728, 95% CI 0.594-0.862, p = 0.002) and similar cut-off (≥ 1.05, sensitivity 77.8%, specificity 66.7%). CONCLUSION: NLR ratio can be a useful parameter for the prediction of post-traumatic CSDH recurrence. This hypothesis was validated in an independent sample and the accuracy was moderate.


Assuntos
Hematoma Subdural Crônico , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Hematoma Subdural Crônico/cirurgia , Humanos , Linfócitos , Masculino , Pessoa de Meia-Idade , Neutrófilos , Complicações Pós-Operatórias/epidemiologia , Recidiva , Estudos Retrospectivos , Fatores de Risco
15.
Acta Neurochir (Wien) ; 164(1): 61-77, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34854993

RESUMO

BACKGROUND: To examine published data and assess evidence relating to safety and efficacy of surgical management of symptomatic pineal cysts without hydrocephalus (nhSPC), we performed a systematic review of the literature and meta-analysis. METHODS: Following the PRISMA guidelines, we searched Pubmed and SCOPUS for all reports with the query 'Pineal Cyst' AND 'Surgery' as of March 2021, without constraints on study design, publication year or status (PROSPERO_CRD:42,021,242,517). Assessment of 1537 hits identified 26 reports that met inclusion and exclusion criteria. RESULTS: All 26 input studies were either case reports or single-centre retrospective cohorts. The majority of outcome data were derived from routine physician-recorded notes. A total of 294 patients with surgically managed nhSPC were identified. Demographics: Mean age was 29 (range: 4-63) with 77% females. Mean cyst size was 15 mm (5-35). Supracerebellar-infratentorial approach was adopted in 90% of cases, occipital-transtentorial in 9%, and was not reported in 1%. Most patients were managed by cyst resection (96%), and the remainder by fenestration. Mean post-operative follow-up was 35 months (0-228). PRESENTATION: Headache was the commonest symptom (87%), followed by visual (54%), nausea/vomit (34%) and vertigo/dizziness (31%). Other symptoms included focal neurology (25%), sleep disturbance (17%), cognitive impairment (16%), loss of consciousness (11%), gait disturbance (11%), fatigue (10%), 'psychiatric' (2%) and seizures (1%). Mean number of symptoms reported at presentation was 3 (0-9). OUTCOMES: Improvement rate was 93% (to minimise reporting bias only consecutive cases from cohort studies were considered, N = 280) and was independent of presentation. Predictors of better outcomes were large cyst size (OR = 5.76; 95% CI: 1.74-19.02) and resection over fenestration (OR = 12.64; 3.07-52.01). Age predicted worse outcomes (OR = 0.95; 0.91-0.99). Overall complication rate was 17% and this was independent of any patient characteristics. Complications with long-term consequences occurred in 10 cases (3.6%): visual disturbance (3), chronic incisional pain (2), sensory disturbance (1), fatigue (1), cervicalgia (1), cerebellar stroke (1) and mortality due to myocardial infarction (1). CONCLUSIONS: Although the results support the role of surgery in the management of nhSPCs, they have to be interpreted with a great deal of caution as the current evidence is limited, consisting only of case reports and retrospective surgical series. Inherent to such studies are inhomogeneity and incompleteness of data, selection bias and bias related to assessment of outcome carried out by the treating surgeon in the majority of cases. Prospective studies with patient-reported and objective outcome assessment are needed to provide higher level of evidence.


Assuntos
Cistos , Hidrocefalia , Glândula Pineal , Adulto , Cistos/cirurgia , Feminino , Humanos , Hidrocefalia/etiologia , Hidrocefalia/cirurgia , Masculino , Glândula Pineal/cirurgia , Estudos Prospectivos , Estudos Retrospectivos , Resultado do Tratamento
16.
Acta Neurochir (Wien) ; 164(4): 1115-1123, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35039959

RESUMO

INTRODUCTION: Depending on severity of presentation, pituitary apoplexy can be managed with acute surgery or non-operatively. We aim to assess long-term tumour control, visual and endocrinological outcomes following pituitary apoplexy with special emphasis on patients treated non-operatively. METHODS: Multicentre retrospective cohort study. All patients with symptomatic pituitary apoplexy were included. Patients were divided into 3 groups: group 1: surgery within 7 days; group 2: surgery 7 days-3 months; group 3: non-operative. Further intervention for oncological reasons during follow-up was the primary outcome. Secondary outcome measures included visual and endocrinological function at last follow-up. RESULTS: One hundred sixty patients were identified with mean follow-up of 48 months (n = 61 group 1; n = 34 group 2; n = 64 group 3). Factors influencing decision for surgical treatment included visual acuity loss (OR: 2.50; 95% CI: 1.02-6.10), oculomotor nerve palsy (OR: 2.80; 95% CI: 1.08-7.25) and compression of chiasm on imaging (OR: 9.50; 95% CI: 2.06-43.73). Treatment for tumour progression/recurrence was required in 17%, 37% and 24% in groups 1, 2 and 3, respectively (p = 0.07). Urgent surgery (OR: 0.16; 95% CI: 0.04-0.59) and tumour regression on follow-up (OR: 0.04; 95% CI: 0.04-0.36) were independently associated with long-term tumour control. Visual and endocrinological outcomes were comparable between groups. CONCLUSION: Urgent surgery is an independent predictor of long-term tumour control following pituitary apoplexy. However, 76% of patients who successfully complete 3 months of non-operative treatment may not require any intervention in the long term.


Assuntos
Apoplexia Hipofisária , Neoplasias Hipofisárias , Acidente Vascular Cerebral , Humanos , Apoplexia Hipofisária/diagnóstico por imagem , Apoplexia Hipofisária/cirurgia , Neoplasias Hipofisárias/complicações , Neoplasias Hipofisárias/diagnóstico por imagem , Neoplasias Hipofisárias/cirurgia , Estudos Retrospectivos , Acidente Vascular Cerebral/complicações , Resultado do Tratamento
18.
BMC Public Health ; 21(1): 618, 2021 03 30.
Artigo em Inglês | MEDLINE | ID: mdl-33785012

RESUMO

BACKGROUND: Despite current preventative strategies, road traffic collisions (RTCs) and resultant neurotrauma remain a major problem in India. This study seeks to explore local perspectives in the context within which RTCs take place and identify potential suggestions for improving the current status. METHODS: Ten semi-structured interviews were carried out with purposively selected key informants from the city of Visakhapatnam, Andhra Pradesh. Participants were from one of the following categories: commissioning stakeholders; service providers; community or local patient group/advocacy group representatives. Transcripts from these interviews were analysed qualitatively using the Framework Method. RESULTS: Participants felt RTCs are a serious problem in India and a leading cause of neurotrauma. Major risk factors identified related to user behaviour such as speeding and not using personal safety equipment, and the user state, namely drink driving and underage driving. Other reported risk factors included poor infrastructure, moving obstacles on the road such as other vehicles, pedestrians and animals, overloaded vehicles and substandard safety equipment. Participants discussed how RTCs affect not only the health of the casualty, but are also a burden to the healthcare system, families, and the national economy. Although there are ongoing preventative strategies being carried out by both the government and the community, challenges to successful prevention emerged from the interviews which included resource deficiencies, inconsistent implementation, lack of appropriate action, poor governance, lack of knowledge and the mindset of the community and entities involved in prevention. Recommendations were given on how prevention of RTCs and neurotrauma might be improved, addressing the areas of education and awareness, research, the pre-hospital and trauma systems, enforcement and legislation, and road engineering, in addition to building collaborations and changing mindsets. CONCLUSIONS: RTCs remain a major problem in India and a significant cause of neurotrauma. Addressing the identified gaps and shortfalls in current approaches and reinforcing collective responsibility towards road safety would be the way forward in improving prevention and reducing the burden.


Assuntos
Condução de Veículo , Pedestres , Ferimentos e Lesões , Acidentes de Trânsito/prevenção & controle , Cidades , Humanos , Índia/epidemiologia , Ferimentos e Lesões/epidemiologia , Ferimentos e Lesões/prevenção & controle
19.
Acta Neurochir Suppl ; 131: 87-90, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33839825

RESUMO

BACKGROUND: Decompressive craniectomy (DC) may reduce mortality but might increase the number of survivors in a vegetative state. In this study, we assessed the long-term functional outcome of patients undergoing DC in a middle-income country. METHODS: This was a prospective observational study of patients undergoing DC at a single tertiary hospital in southern Brazil between January 2015 and December 2018. RESULTS: Of the 125 patients who were included in this study, 57.6% (72/125) had a traumatic brain injury (TBI), 21.6% (27/125) had a stroke, 19.2% (24/125) had a cerebral hemorrhage (intracerebral or subarachnoid hemorrhage), and 0.8% (1/125) had a cerebral abscess. The mean age was 45.18 ± 19.6 years, and 71% of the patients were men. The mean initial Glasgow Coma Scale (GCS) score was 7.8 ± 3.6. The in-hospital mortality rate was 44.8% (56/125). Of the survivors, 50.7% (35/69) had a favorable outcome 6 months after DC. After multivariate analysis, a lower initial GCS score (7.5 ± 3.6 versus 8.8 ± 3.5, P = 0.007) and older age (49.7 ± 18.9 versus 33.3 ± 16.2 years, P = 0.0001) were associated with an unfavorable outcome. CONCLUSION: Six months after DC, almost half of the patients who survive have a favorable outcome.


Assuntos
Lesões Encefálicas Traumáticas , Craniectomia Descompressiva , Adulto , Idoso , Lesões Encefálicas Traumáticas/epidemiologia , Lesões Encefálicas Traumáticas/cirurgia , Países em Desenvolvimento , Humanos , Masculino , Estudos Retrospectivos , Resultado do Tratamento
20.
Acta Neurochir Suppl ; 131: 79-82, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33839823

RESUMO

After decompressive craniectomy (DC), cranioplasty (CP) can help to normalize vascular and cerebrospinal fluid circulation besides improving the patient's neurological status. The aim of this study was to investigate the effects of CP on cerebral hemodynamics and on cognitive and functional outcomes in patients with and without a traumatic brain injury (TBI). Over a period of 3 years, 51 patients were included in the study: 37 TBI patients and 14 non-TBI patients. The TBI group was younger (28.86 ± 9.71 versus 45.64 ± 9.55 years, P = 0.0001), with a greater proportion of men than the non-TBI group (31 versus 6, P = 0.011). Both groups had improved cognitive outcomes (as assessed by the Mini-Mental State Examination) and functional outcomes (as assessed by the Barthel Index and Modified Rankin Scale) 90 days after CP. In the TBI group, the mean velocity of blood flow in the middle cerebral artery ipsilateral to the cranial defect increased between the time point before CP and 90 days after CP (34.24 ± 11.02 versus 42.14 ± 10.19 cm/s, P = 0.0001). In conclusion, CP improved the neurological status in TBI and non-TBI patients, but an increment in cerebral blood flow velocity after CP occurred only in TBI patients.


Assuntos
Lesões Encefálicas Traumáticas , Lesões Encefálicas , Craniectomia Descompressiva , Procedimentos de Cirurgia Plástica , Lesões Encefálicas Traumáticas/complicações , Lesões Encefálicas Traumáticas/cirurgia , Hemodinâmica , Humanos , Masculino , Crânio/cirurgia
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