by Deye Ge, Liyan Wu, Jingrong Yang, Jingxian Sun, Jinying Wang, Jingxin Wang, Huihui Song, Ran Wei, Zecheng Xu, Binbin Zhao, Rongfei Sun, Yifei Wang
The U.S. Food and Drug Administration (FDA) approved intravenous edaravone for the treatment of amyotrophic lateral sclerosis (ALS) in 2017, followed by the approval of the oral formulation in 2022. This study aims to utilize the FDA#39;s Adverse Event Reporting System (FAERS) to investigate the spectrum and timing of adverse events (AEs) associated with edaravone administration, employing repeatability analysis, the Reporting Odds Ratio (ROR) approach, Weibull distribution, and stratification methods. The investigation focuses on data collected from the first quarter of 2017 through the fourth quarter of 2024, aiming to identify adverse event signals and their temporal patterns related to both intravenous and oral edaravone administration. In total, 3,262 records of edaravone-related adverse reactions were identified; among these, 1,534 incidents were associated with intravenous administration, while 453 incidents pertained to oral administration. The analysis revealed distinct adverse reaction profiles for the two routes of administration. Notably, the spectrum of adverse reactions resulting from oral administration predominantly involved the respiratory system, digestive system, and skin damage. In contrast, intravenous administration was more frequently linked to complications associated with invasive procedures and local tissue damage. Furthermore, the timing of adverse reactions exhibited significant variability between the two routes. Weibull distribution analysis indicated that the median onset time for adverse reactions following intravenous administration was 35 days, whereas for oral administration, it was 27 days. Both analytical approaches identified early failure signals, suggesting that the risk of adverse events diminishes over time.The COVID-19 pandemic threatened global HIV Test and Treat Efforts. We assessed whether it affected (1) the number of antiretroviral therapy (ART) initiations and (2) the proportion of timely ART initiations in people living with HIV (PLWH) globally.
Quasi-experimental, regression discontinuity design using routinely collected data from HIV clinics.
360 HIV care clinics across primary and secondary levels of care, participating in the International epidemiology Databases to Evaluate AIDS consortium, in 31 countries in Asia, Africa and the Americas.
177 391 PLWH (≥18 years old) who initiated ART 2 years before and 1 year after the onset of the COVID-19 pandemic in their country.
The primary outcome was the number of ART initiations per week; the secondary outcome was the proportion of timely ART initiations (ie, ART initiated within 7 days of enrolment). We assessed changes in these outcomes in the 52 weeks after compared to the 104 weeks before the pandemic onset, defined using each country’s peak Oxford Stringency Index score between January and June 2020.
Among 177 391 newly enrolled PLWH, 129 743 initiated during the pre-pandemic and 47 648 post-pandemic onset. 72.5% of ART initiations were timely pre-pandemic whereas 82.3% were during the pandemic. Absolute number of ART initiations remained stable during the pandemic period in 25 of 31 countries but decreased significantly in six countries: India (–5.0 p, 95% CI –9.2 to –0.7), Rwanda (–10.0 p, –18.6 to –1.4), Malawi (–33.4 p, –54.1 to –12.3), South Africa (–130.8 p, –188.6 to –73.1), Zimbabwe (–12.9 p, –20.0 to –5.8) and Togo (–19.6 p, –39.1 to –0.1). The proportion of timely initiations was stable in all countries except in Kenya (+4.2 pp, 95% CI +0.3 to +8.1) and in Mozambique (+2.7 pp, +0.5 to +4.9), where it increased significantly.
A deeper understanding of the factors that contributed to sustaining ART initiations, particularly in settings with stringent public health and social measures, is needed. These insights should inform preparedness strategies, resource allocation and policy development to ensure continuity of HIV services during future health emergencies, in line with World Health Organisation recommendations.
The use of economic evidence to prioritise vaccines and delivery strategies to optimally use in immunisation systems is becoming a global priority, especially in low- and middle-income countries (LMICs), in view of challenges in funding and the need to make more efficient use of available resources. We undertook a scoping review to identify and synthesise available evidence on strategies that have been used to enhance the use of economic evidence in policy and decision-making in the immunisation ecosystem in LMICs. The review was also used to identify the facilitators and constraints to the use of economic evidence for vaccination policy and decision making in LMICs and the sustainability of the identified strategies.
A scoping literature review was undertaken to generate the evidence. The review adhered to the first five steps of Arksey and O’Malley’s methodological framework (identifying and refining the research questions, identifying relevant articles, selection of studies, data extraction and charting and data synthesis) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews.
Full-text articles were searched on PUBMED, HINARI and DOAJ using different combinations of search words as of 16 December 2024
We included articles from LMICs, including Africa, and global experiences, including those from LMICs. Papers must be written in English or have an English language translation available and published between 1 January 2004 and 16 December 2024.
Two independent reviewers used standardised methods to search, extract, and screen included studies. The findings from the review were summarized in themes that were synthesized qualitatively.
18 eligible articles met the inclusion criteria and were included in the synthesis. It was found that economic evidence was systematically requested and demonstrably influencing vaccine introduction or prioritisation decisions in only eight out of 32 LMIC settings with functional National Immunization Technical Advisory Groups (NITAGs) and in fewer than 20% of documented new vaccine introduction processes since 2015. In the majority of cases, decisions were reported as being driven primarily by disease burden, political priority, donor recommendations or historical precedent, with economic analyses either absent, produced post hoc or acknowledged but not used as a decisive factor.
There is minimal use of evidence from economics in decision-making within the immunisation ecosystem. Expert advisory committees in LMICS can, however, enhance the use of economic evidence in vaccination policy and decision-making. Hence, in order to use economic evidence for decision making, national advisory committees such as NITAGs need enhanced capacity, independence and close collaboration with researchers. LMIC NITAGs could also benefit from tailored adaptations, such as simplified cost-effectiveness tools and regional economic data hubs, to bridge this gap in decision-making and bring economic evidence to the fore of their decisions.
Prehospital notification by emergency medical services (EMS) can activate hospital resources before the patient arrives, which has been shown to improve in-hospital care for stroke patients. Optimising prehospital and handover processes in stroke care requires considering end-user perspectives to enhance acceptance and effectiveness of the developed solutions. The aim of this study was to identify current barriers in the preclinical-clinical phase of stroke care.
Within the investigator-initiated CAEHR project (CArdiovascular diseases—Enhancing Healthcare through cross-sectoral Routine data integration), an interface for transferring data from the electronic prenotification system to the hospital information system is implemented. A mixed-methods approach with semi-structured interviews as well as a cross-sectional online survey was used to gather feedback from healthcare professionals at a single stroke centre in Germany as well as from the participating EMS personnel. Data collection for the interviews was conducted between January and August 2023 and for the online survey between May and September 2023.
Interviews were conducted with 10 healthcare professionals, including seven from the neurological clinic and three from EMS. Additionally, 39 EMS employees took part in a cross-sectional online survey.
Challenges identified were educational and training aspects affecting preclinical processes and patient handover procedures, along with the opportunity for establishing more uniform protocols. Participants emphasised the importance of detailed patient information. Electronic prenotification was seen as an important step regarding structured information transmission, reducing the risk of information loss in stroke care.
The study highlights the importance of addressing organisational processes in addition to technical interfaces for implementing effective stroke care processes.
German Clinical Trials Register, DRKS00029103.