Assessing the reporting quality of adult neuro-oncology protocols, abstracts, and trials: Adherence to the SPIRIT and CONSORT statements.

Background: Comprehensive and transparent reporting of clinical trial activity is important. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and Consolidated Standards of Reporting Trials (CONSORT) 2010 statements define the items to be reported in clinical trial protocols and randomized controlled trials, respectively. The aim of this methodological review was to assess the reporting quality of adult neuro-oncology trial protocols and trial result articles. Methods: Adult primary and secondary brain tumor phase 3 trial protocols and result articles published after the introduction of the SPIRIT 2013 statement, were identified through searches of 4 electronic bibliographic databases. Following extraction of baseline demographic data, the reporting quality of independently included trial protocols and result articles was assessed against the SPIRIT and CONSORT statements respectively. The CONSORT-A checklist, an extension of the CONSORT 2010 statement, was used to specifically assess the abstract accompanying the trial results article. Percentage adherence (standard deviation [SD]) was calculated for each article. Results: Seven trial protocols, and 36 trial result articles were included. Mean adherence of trial protocols to the SPIRIT statement was 79.4% (SD: 0.11). Mean adherence of trial abstracts to CONSORT-A was 75.3% (SD: 0.12) and trial result articles to CONSORT was 74.5% (SD: 0.10). Conclusion: The reporting quality of adult neuro-oncology trial protocols and trial result articles requires improvement to ensure comprehensive and transparent communication of planned neuro-oncology clinical trials and results within the literature. Raising awareness by clinical triallists and implementing mandatory evidence of proof of adherence by journals should improve reporting quality.

Intracranial Empyemas in the COVID-19 Era: A New Phenomenon? A Paediatric Case Series and Review of the Literature.

INTRODUCTION: We present the largest series of paediatric intracranial empyemas occurring after COVID-19 infection to date, and discuss the potential implications of the pandemic on this neurosurgical pathology. METHODS: Patients admitted to our centre between January 2016 and December 2021 with a confirmed radiological diagnosis of intracranial empyema were retrospectively reviewed, excluding non-otorhinological source cases. Patients were grouped according to onset before or after onset of the COVID-19 pandemic and COVID-19 status. A literature review of all post-COVID-19 intracranial empyemas was performed. SPSS v27 was used for statistical analysis. RESULTS: Sixteen patients were diagnosed with intracranial empyema: n = 5 prior to 2020 and n = 11 after, resulting in an average annual incidence of 0.3% prior to onset of the pandemic and 1.2% thereafter. Of those diagnosed since the pandemic, 4 (25%) were confirmed to have COVID-19 on recent PCR test. Time from COVID-19 infection until empyema diagnosis ranged from 15 days to 8 weeks. Mean age for post-COVID-19 cases was 8.5 years (range: 7-10 years) compared to 11 years in non-COVID cases (range: 3-14 years). Streptococcus intermedius was grown in all cases of post-COVID-19 empyema, and 3 of 4 (75%) post-COVID-19 cases developed cerebral sinus thromboses, compared to 3 of 12 (25%) non-COVID-19 cases. All cases were discharged home with no residual deficit. CONCLUSION: Our post-COVID-19 intracranial empyema series demonstrates a greater proportion of cerebral sinus thromboses than non-COVID-19 cases, potentially reflecting the thrombogenic effects of COVID-19. Incidence of intracranial empyema at our centre has increased since the start of the pandemic, causes of which require further investigation and multicentre collaboration.

Opportunities and challenges for the development of "core outcome sets" in neuro-oncology.

Core Outcome Sets (COS) define minimum outcomes to be measured and reported in clinical effectiveness trials for a particular health condition/health area. Despite recognition as critical to clinical research design for other health areas, none have been developed for neuro-oncology. COS development projects should carefully consider: scope (how the COS should be used), stakeholders involved in development (including patients as both research partners and participants), and consensus methodologies used (typically a Delphi survey and consensus meeting), as well as dissemination plans. Developing COS for neuro-oncology is potentially challenging due to extensive tumor subclassification (including molecular stratification), different symptoms related to anatomical tumor location, and variation in treatment options. Development of a COS specific to tumor subtype, in a specific location, for a particular intervention may be too narrow and would be unlikely to be used. Equally, a COS that is applicable across a wider area of neuro-oncology may be too broad and therefore lack specificity. This review describes why and how a COS may be developed, and discusses challenges for their development, specific to neuro-oncology. The COS under development are briefly described, including: adult glioma, incidental/untreated meningioma, meningioma requiring intervention, and adverse events from surgical intervention for pediatric brain tumors.

Experiences, perceptions and potential impact of community-based mentor mothers supporting pregnant and postpartum women with HIV in Kenya: a mixed-methods study.

INTRODUCTION: Community-based mentor mothers (cMMs) are women living with HIV who provide peer support to pregnant/postpartum women living with HIV (PWLWH) to enhance antiretroviral therapy (ART) adherence, retention in care and prevent perinatal transmission of HIV. The goal of this study was to explore the experiences, perceptions, mechanisms and health impact of cMMs on PWLWH in Kenya from the perspective of cMMs. METHODS: We conducted a prospective mixed-methods study in southwestern Kenya in 2015-2018. In the qualitative phase, we completed in-depth interviews with cMMs to explore their perceptions and experiences in supporting PWLWH. Transcripts were broad-coded according to identified themes, then fine-coded using an inductive approach. In the quantitative phase, we analysed medical record data from PWLWH who were randomized in the cMM intervention to examine the impact of cMM visits on optimal prevention of mother-to-child transmission (PMTCT). We used cluster-adjusted generalized estimating equation models to examine relationships with a composite outcome (facility delivery, infant HIV testing, ART adherence and undetectable viral load at 6 weeks postpartum). Finally, qualitative and quantitative results were integrated. RESULTS: Convergence of findings from cMM interviews (n = 24) and PWLWH medical data (n = 589) revealed: (1) The cMM intervention was utilized and perceived as acceptable. PWLWH received, on average, 6.2 of 8 intended home visits through 6 weeks postpartum. (2) The cMMs reported serving as role models and confidantes, supporting PWLWH's acceptance of their HIV status, providing assurances about PMTCT and assisting with male partner disclosure and communication. cMMs also described benefits for themselves, including empowerment and increased income. (3) The cMM visits supported PWLWH's completion of PMTCT steps. Having ≥4 cMM home visits up to 6 weeks postpartum, as compared to <4 visits, was associated with higher likelihood of an optimal PMTCT composite outcome (adjusted relative risk 1.42, p = 0.044). CONCLUSIONS: We found that peer support from cMMs during pregnancy through 6 weeks postpartum was associated with improved uptake of critical PMTCT services and health behaviours and was perceived as beneficial for cMMs themselves. CMM support of PWLWH may be valuable for other low-resource settings to improve engagement with lifelong ART and HIV services among PWLWH.

Electrically assisted pedal cycles: is new legislation required to mitigate increased head injury risk?

OBJECTIVES: Electrically Assisted Pedal Cycles (EAPCs) are pedal bikes that are fitted with a motor that travel at higher speeds than conventional bicycles. Recent international data shows that there is an association with increased severity of injury, particularly in paediatric populations. Currently, EAPCs are subject to the same legislation regarding helmet use as pedal bikes in the UK and EU which does not mandate the use of a helmet. Here we examine safety concerns surrounding EAPCs in the context of existing EU and UK legislation to assess whether changes to these should be made by public health bodies to mitigate the increased risk of injury. METHODS: A retrospective international literature review looking at electric bicycle-related trauma and legislation was conducted using a systematic search of internet databases. Peer-reviewed articles and online resources were reviewed based on relevance to the above objective. RESULTS: EAPCS can travel at up to 17.5 mph, resulting in higher speeds of travel and collision. The use of EAPCs has been associated with increased severity of head injuries. Bicycle helmets have been shown to reduce the severity of head injury in accidents involving both EAPCs and pedal cycles. Healthcare providers should pay extra attention to the possibility of severe injuries when a patient had a bicycle accident with an EAPC, especially in paediatric populations. CONCLUSIONS: Given that EAPCS have been associated internationally with increased severity of head injuries we propose that existing EU and UK legislation may not be fit for purpose with respects to increased EAPC usage and criteria for impact protection of existing helmets. Further research and audit with more accurate recording of data associated with EAPCs use and associated injuries would inform enhanced regulation regarding EAPC usage in the future.

The Influence of Epigenetic Factors in Four Pairs of Twins With Non-Syndromic Craniosynostosis.

The aims of this retrospective case series were to investigate whether twins born with craniosynostosis mirrored each other regarding operative surgery performed, age of undertaking surgery; outcomes in speech, language, and developmental milestones and what environmental factors were present for each set of twins.Case selection was based on clinical and radiographical evidence of craniosynostosis amongst twin sets. The twin sets included were those with craniosynostosis who had different sutures affected or those with the same suture affected but with a varying degree of severity.The presence of the following factors may have played an influential role in the clinical presentation of the twins; these were as follows: a maternal history of smoking, breech presentation, and genetic mutations. It was notable that the overall outcomes for the twins in this study were similar.These cases highlight the multifactorial nature in the development of craniosynostosis and how this influenced the phenotypic presentation of the twins.