Use of Sham Interventions in Randomized Controlled Trials in Neurosurgery.

BACKGROUND: The use of sham interventions in randomized controlled trials (RCTs) is essential to minimize bias. However, their use in surgical RCTs is rare and subject to ethical concerns. To date, no studies have looked at the use of sham interventions in RCTs in neurosurgery. METHODS: This study evaluated the frequency, type, and indication of sham interventions in RCTs in neurosurgery. RCTs using sham interventions were also characterized in terms of design and risk of bias. RESULTS: From a total of 1,102 identified RCTs in neurosurgery, 82 (7.4%) used sham interventions. The most common indication for the RCT was the treatment of pain (67.1%), followed by the treatment of movement disorders and other clinical problems (18.3%) and brain injuries (12.2%). The most used sham interventions were saline injections into spinal structures (31.7%) and peripheral nerves (10.9%), followed by sham interventions in cranial surgery (26.8%), and spine surgery (15.8%). Insertion of probes or catheters for a sham lesions was performed in 14.6%.In terms of methodology, most RCTs using sham interventions were double blinded (76.5%), 9.9% were single blinded, and 13.6% did not report the type of blinding. CONCLUSION: Sham-controlled RCTs in neurosurgery are feasible. Most aim to minimize bias and to evaluate the efficacy of pain management methods, especially in spinal disorders. The greatest proportion of sham-controlled RCTs involves different types of substance administration routes, with sham surgery the less commonly performed.

Electronic search strategies fail to identify randomized controlled trials (RCTs) in neurosurgery.

Randomized controlled trials (RCTs) are the gold standard studies to evaluate the efficacy of therapeutic interventions. Although they are frequently identified through open searches in electronic databases, no studies have evaluated how easy it is to identify RCTs in neurosurgery using electronic search strategies. The present study evaluated the sensitivity and specificity of different search strategies applied to commonly used databases to identify RCTs in neurosurgery. The total number of RCTs in neurosurgery published between 1960 and 2013 was determined through a detailed search involving open keyword searches in PubMed, Cochrane Library and Center for Reviews and Dissemination (CRD) databases, a PubMed search based on clinical entity-related keywords and hand-searches on the reference list of identified articles. The sensitivity and specificity were calculated for the open keyword searches on PubMed, the Cochrane Library and the CRD database and for the Cochrane's HSSS, based on the total number of the identified RCTs. Compared to the total of 1102 RCTs identified, PubMed open search yielded 4660 articles, among which 365 were RCTs (sensitivity: 33.1%; specificity: 7.8%). Cochrane open search yielded 621 among which 36 were RCTs (sensitivity: 3.2%; specificity: 5.8%) and CRD open search returned 78 articles, among which 4 were RCTs (sensitivity: 0.4% sensitivity; specificity: 5.1%). The Cochrane HSSS retrieved 10702 results, among which 340 were RCTs (sensitivity: 30.9%; specificity: 3.2%). Most RCTs in neurosurgery cannot be identified by commonly used search strategies, which emphasizes the need to improve their indexing.

Treatment of childhood diffuse brain stem tumors: comparison of results in different treatment modalities.

BACKGROUND: Diffuse brainstem tumors in children are rare and its treatment is controversial. Although radiotherapy (RT) used to be the treatment of choice, results remained unsatisfactory. The association of RT with other therapies is common, but lacks scientific data regarding its efficacy. Comparison of results of irradiation alone versus combined treatment modalities is crucial in improving survival. METHOD: The authors reviewed twenty-four patients with diffuse brainstem tumors, with mean age of 7 years, treated from December 90 to November 99, at the University of Sao Paulo, Brazil. These patients were subdivided in four groups according to the treatment option at the onset of symptoms. Four patients were treated with radiation alone (total dose of 50 Gy to 62.4 Gy), 6 patients with chemotherapy and radiation, 8 with tamoxifen and radiation and 6 with tamoxifen, radiation and chemotherapy. The results of the different groups were them compared. FINDINGS: Clinical response was observed in 83.3% of our children, briefly followed by progressive disease. Mean survival was 17 months with no statistically significant differences among the groups. Four patients were alive at the end of the study, with a mean survival of 32.4 months, all of them received combined therapy, but with no statistically significant differences. CONCLUSIONS: Neither the association of radiation therapy with chemotherapy, tamoxifen nor both have showed survival improvement. The prognosis of these patients remains very poor and only investigational trials would justify a highly aggressive approach.

Endoscopic third ventriculostomy in children younger than 1 year of age.

OBJECT: The authors analyzed data obtained in 36 patients younger than 1 year of age who were treated with endoscopic third ventriculostomy (ETV) for obstructive hydrocephalus at their institution. METHODS: There were 17 boys and 19 girls who ranged in age from 3 days to 11 months (mean 4.7 months). The causes of the hydrocephalus were Chiari Type II malformation (11 cases), aqueductal stenosis (11 cases), and other (14 cases). The success rate was 64% (p < 0.05, confidence interval 0.48-0.8) and there were four complications, mainly meningitis. The follow-up period ranged from 22 to 69 months (mean 47.4 months). CONCLUSIONS: Based on the 64% success rate in children younger than 1 year of age, ETV should be the treatment of choice for obstructive hydrocephalus in this age group, although larger studies involving specific causes of hydrocephalus are needed.

Information Sources and Decision-Making in Neurosurgery: Results of a Survey of Members of the Brazilian Neurosurgery Society

Introduction In all surgical disciplines, including neurosurgery, there are questions about the level of evidence supporting surgical practices and the mechanisms and adequacy of knowledge translation. Objectives To assess the perception of Brazilian neurosurgeons of information sources and decision-making mechanisms related to their medical practices. Methods An online questionnaire was sent to the 2,400 members of the Brazilian Neurosurgical Society. Results A total of 32% of the neurosurgeons completed the questionnaire, 53% had more than 10 years experience, 67% had worked in public hospitals, 34% had performed spine surgeries, and 30% had performed brain tumor surgeries. The therapeutic decisions were based mostly on internship learning (54%) and personal professional experience (52%). The most common information sources were scientific abstracts (53%) and the Internet (47%). A total of 89% believed that evidence-based medicine was relevant, 93% believed protocols or guidelines were necessary, and 74% subscribed to a medical journal. Nonetheless, only 43% had protocols implemented in their services, 93% highly valued a surgeon's personal experience, and 63% showed little familiarity with the interpretation of scientific concepts in the literature. Among the respondents, 83% were willing to try an innovative treatment alternative if it was shown to improve clinical outcomes and reduce severe complications. Conclusions The disparity in the responses highlights the need to implement recommendations that improve decision-making mechanisms.

Introdução Em todas as disciplinas cirúrgicas, incluindo a neurocirurgia, existem questões sobre o nível de evidência que apoia as práticas cirúrgicas e os mecanismos e adequação da translação do conhecimento. Objetivos Avaliar a percepção de fontes de informação e mecanismos de tomada de decisão dos neurocirurgiões brasileiros em relação às práticas médicas. Métodos Um questionário on-line foi enviado aos 2.400 membros da Sociedade Brasileira de Neurocirurgia. Resultados Um total de 32% dos neurocirurgiões preencheram o questionário, 53% tinham mais de 10 anos de experiência, 67% trabalharam em hospitais públicos, 34% realizaram cirurgia de coluna, e 30%, de cérebro. As decisões terapêuticas basearam-se principalmente no aprendizado de estágio (54%) e na experiência profissional pessoal (52%). As fontes de informação mais comuns foram resumos científicos (53%) e a Internet (47%). Um total de 89% acreditava que a medicina baseada em evidências era relevante, 93% acreditavam que protocolos ou diretrizes eram necessários, e 74% tinham assinaturas de uma revista médica. No entanto, apenas 43% apresentaram protocolos implementados em seus serviços, 93% valorizaram a experiência pessoal de um cirurgião, e 63% mostraram pouca familiaridade com a interpretação de conceitos científicos na literatura. Entre os respondentes, 83% estavam dispostos a tentar uma alternativa de tratamento inovador se este demonstrasse melhorar os resultados clínicos e reduzir as complicações graves. Conclusões A disparidade nas respostas destaca a necessidade de implementar recomendações que melhorem os mecanismos de tomada de decisão.

Fungal meningoencephalitis caused by Alternaria: a clinical case.

Cerebral phaeohyphomycosis is an infrequent infectious condition associated with a high mortality rate. The authors describe a very rare case that occurred in an immunocompetent 18-year-old man who developed severe meningoencephalitis and arachnoiditis caused by Alternaria alternata, which were diagnosed in the context of difficult-to-treat hydrocephalus. Etiological diagnosis was made based on fungal culture and histopathologic examination. Empirical treatment consisted of an early aggressive antifungal combination therapy consisting of intravenous liposomal amphotericin B (5 mg/kg per day) and voriconazole (4 mg/kg every 12 h), which initially induced a favorable response. Following the fungus identification, the choice for the combination of posaconazole (400 mg every 12 h) plus flucytosine (4000 mg/day) proved to be effective in the suppression of the signs and symptoms of this uncommon cerebral mycosis. At a 12-month follow-up visit no recurrence had occurred and posaconazole was then stopped.

Cavernoma familiar / Familial cavernoma

Angiomas cavernosos ou simplesmente cavernomas são má-formações vasculares congênitas raras, acometendo 0,5% da população, podendo apresentar-se sob as formas esporádica e familiar. Quando acomete indivíduos de uma mesma família é denominado cavernomatose cerebralfamiliar (CCF), tendo sua transmissão autossômica dominante com penetração incompleta associada a mutações no locus CCF1 no cromossomo 7. A CCF acomete, em geral, vários indivíduos de uma mesma família, grande parte desses com lesões múltiplas, algumas vezes até com aparecimento tardio. Essas características apontam para a necessidade de uma abordagem diferenciada de indivíduos com cavernomas múltiplos esuas famílias. Relatamos o caso de um paciente de 5 anos de idade, com três cavernomas cerebrais, e sua irmã de 3 anos, com outra lesão. Discutimos o tratamento e o seguimento deles e de sua família, propondo sugestões para a abordagem da CCF.

Cavernous hemangiomas or simply cavernomas are rare congenital vascular malformations mostly located in the central nervous system, which prevalence is close to 0.5% in the general population.They can present itself either as a sporadic case or in a familial form. The familial form is called familial cerebral cavernomatosis (FCC), having an autossomical dominant inheritance with incomplete penetration associated to mutations of the CCF1 locus on chromossome 7. In general, CCF is present in many individuals of a given family, mostly with multiple lesions, some of those even with a late onset. These characteristics imply the need of a special approach towards diagnosis and treatment of patients with multiple cavernomas and their families. We report the case of a 5 year-old boy with three cerebral cavernomas and of his 3 year-old sisterwith another lesion. The treatment and the management of familiar forms of cavernomas are discussed.