This is the second in a series of four papers updating the European Cystic Fibrosis Society (ECFS) standards for the care of people with CF. This paper focuses on establishing and maintaining health. The guidance is produced using an evidence-based framework and with wide stakeholder engagement, including people from the CF community. Authors provided a narrative description of their topic and statements, which were more directive. These statements were reviewed by a Delphi exercise, achieving good levels of agreement from a wide group for all statements. This guidance reinforces the importance of a multi-disciplinary CF team, but also describes developing models of care including virtual consultations. The framework for health is reinforced, including the need for a physically active lifestyle and the strict avoidance of all recreational inhalations, including e-cigarettes. Progress with cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy is reviewed, including emerging adverse events and advice for dose reduction and interruption. This paper contains guidance that is pertinent to all people with CF regardless of age and eligibility for and access to modulator therapy.
BACKGROUND AND PURPOSE: Neurological disorders constitute a significant portion of the global disease burden, affecting >30% of the world's population. This prevalence poses a substantial threat to global health in the foreseeable future. A lack of awareness regarding this high burden of neurological diseases has led to their underrecognition, underappreciation, and insufficient funding. Establishing a strategic and comprehensive research agenda for brain-related studies is a crucial step towards aligning research objectives among all pertinent stakeholders and fostering greater societal awareness. METHODS: A scoping literature review was undertaken by a working group from the European Academy of Neurology (EAN) to identify any existing research agendas relevant to neurology. Additionally, a specialized survey was conducted among all EAN scientific panels, including neurologists and patients, inquiring about their perspectives on the current research priorities and gaps in neurology. RESULTS: The review revealed the absence of a unified, overarching brain research agenda. Existing research agendas predominantly focus on specialized topics within neurology, resulting in an imbalance in the number of agendas across subspecialties. The survey indicated a prioritization of neurological disorders and research gaps. CONCLUSIONS: Building upon the findings from the review and survey, key components for a strategic and comprehensive neurological research agenda in Europe were delineated. This research agenda serves as a valuable prioritization tool for neuroscientific researchers, as well as for clinicians, donors, and funding agencies in the field of neurology. It offers essential guidance for creating a roadmap for research and clinical advancement, ultimately leading to heightened awareness and reduced burden of neurological disorders.
- MeSH
- Global Burden of Disease MeSH
- Humans MeSH
- Nervous System Diseases * epidemiology therapy MeSH
- Neurology * MeSH
- Research MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Europe MeSH
Clinical guidelines are evidence-based recommendations developed by healthcare organizations or expert panels to assist healthcare providers and patients in making appropriate and reliable decisions regarding specific health conditions, aiming to enhance the quality of healthcare by promoting best practices, reducing variations in care, and at the same time, allowing tailored clinical decision-making. European Hernia Society (EHS) guidelines aim to provide surgeons a reliable set of answers to their pertinent clinical questions and a tool to base their activity as experts in the management of abdominal wall defects. The traditional approach to guideline production is based on gathering key opinion leader in a particular field, to address a number of key questions, appraising papers, presenting evidence and produce final recommendations based on the literature and consensus. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) method offers a transparent and structured process for developing and presenting evidence summaries and for carrying out the steps involved in developing recommendations. Its main strength lies in guiding complex judgments that balance the need for simplicity with the requirement for complete and transparent consideration of all important issues. EHS guidelines are of overall good quality but the application of GRADE method, began with EHS guidelines on open abdomen, and the increasing adherence to the process, has greatly improved the reliability of our guidelines. Currently, the need to application of this methodology and the creation of stable and dedicated group of researchers interested in following GRADE in the production of guidelines has been outlined in the literature. Considering that the production of clinical guidelines is a complex process, this paper aim to highlights the primary features of guideline production, GRADE methodology, the challenges associated with their adoption in the field of hernia surgery and the project of the EHS to establish a stable guidelines committee to provide technical and methodological support in update of previously published guideline or the creation of new ones.
- Publication type
- Journal Article MeSH
Phthalic acid isomers are the monomers of phthalate molecules, also known as phthalic acid esters, widely employed in the plastics industry. This study aims to investigate the biodegradation of phthalic acid (PA) and terephthalic acid (TPA) by five industry-borne Comamonas testosteroni strains: 3APTOL, 3ABBK, 2B, 3A1, and C8. To assess the ability of C. testosteroni strains to biodegrade phthalic acid isomers in fermentation media, an analytical method was employed, consisting of high-performance liquid chromatography (HPLC) analyses. Subsequently, molecular screening of the genomic and plasmid DNA was conducted to identify the degradative genes responsible for the breakdown of these chemicals. The genes of interest, including ophA2, tphA2, tphA3, pmdA, and pmdB, were screened by real-time PCR. The five C. testosteroni strains effectively degraded 100% of 100 mg/L PA (p = 0.033) and TPA (p = 0.0114). Molecular analyses indicated that all C. testosteroni strains contained the pertinent genes at different levels within their genomes and plasmids, as reflected in the threshold cycle (Ct) values. Additionally, DNA temperature of melting (Tm) analyses uncovered minor differences between groups of genes in genomic and plasmid DNA. C. testosteroni strains could be excellent candidates for the removal of phthalic acid isomers from environmental systems.
BACKGROUND: Monitoring effectiveness of pertussis vaccines is necessary to adapt vaccination strategies. PERTINENT, Pertussis in Infants European Network, is an active sentinel surveillance system implemented in 35 hospitals across six EU/EEA countries. We aim to measure pertussis vaccines effectiveness (VE) by dose against hospitalisation in infants aged <1 year. METHODS: From December 2015 to December 2019, participating hospitals recruited all infants with pertussis-like symptoms. Cases were vaccine-eligible infants testing positive for Bordetella pertussis by PCR or culture; controls were those testing negative to all Bordetella spp. For each vaccine dose, we defined an infant as vaccinated if she/he received the corresponding dose >14 days before symptoms. Unvaccinated were those who did not receive any dose. We calculated (one-stage model) pooled VE as 100*(1-odds ratio of vaccination) adjusted for country, onset date (in 3-month categories) and age-group (when sample allowed it). RESULTS: Of 1,393 infants eligible for vaccination, we included 259 cases and 746 controls. Median age was 16 weeks for cases and 19 weeks for controls (p < 0.001). Median birth weight and gestational age were 3,235 g and week 39 for cases, 3,113 g and week 39 for controls. Among cases, 119 (46 %) were vaccinated: 74 with one dose, 37 two doses, 8 three doses. Among controls, 469 (63 %) were vaccinated: 233 with one dose, 206 two doses, 30 three doses. Adjusted VE after at least one dose was 59 % (95 %CI: 36-73). Adjusted VE was 48 % (95 %CI: 5-71) for dose one (416 eligible infants) and 76 % (95 %CI: 43-90) for dose two (258 eligible infants). Only 42 infants were eligible for the third dose. CONCLUSIONS: Our results suggest moderate one-dose and two-dose VE in infants. Larger sample size would allow more precise estimates for dose one, two and three.
- MeSH
- Hospitalization MeSH
- Infant MeSH
- Humans MeSH
- Whooping Cough * epidemiology prevention & control MeSH
- Pertussis Vaccine MeSH
- Sentinel Surveillance MeSH
- Case-Control Studies MeSH
- Vaccination methods MeSH
- Check Tag
- Infant MeSH
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: Treatment with cladribine tablets (CladT), an immune reconstitution therapy for relapsing multiple sclerosis (RMS), involves two short courses of treatment in Year 1 and Year 2. Most patients achieve sustained efficacy with CladT, but a small proportion may experience new disease activity (DA). Following completion of the indicated dose, physicians may have questions relating to the long-term management of these patients. Since the EU approval of CladT over 5 years ago, real-world evidence (RWE) is increasing and may provide some insights and guidance for clinical practice. We describe a systematic literature review (SLR) of RWE and provide expert opinions relating to six questions regarding the long-term use of CladT. METHODS: Pertinent clinical questions were developed by a steering committee (SC) of 14 international multiple sclerosis (MS) experts regarding breakthrough DA in Year 1, new DA after 2 years or more of treatment, long-term management of stable patients, and whether additional courses of CladT may be required or safe. An SLR was performed in EMBASE and PubMed using the population, intervention, comparators, outcomes, study design (PICOS) framework to identify relevant studies within the last 15 years. Searches of key congress proceedings for the last 2-3 years were also performed. Following review of the results and RWE, the SC drafted and agreed on expert opinion statements for each question. RESULTS: A total of 35 publications reporting RWE for CladT were included in this review. In the real world, breakthrough DA in Year 1 is of low incidence (1.1-21.9%) but can occur, particularly in patients switching from anti-lymphocyte trafficking agents. In most patients, this DA did not lead to treatment discontinuation. Reported rates of DA after the full therapeutic effect of CladT has been achieved (end of Year 2, 3 or 4) range from 12.0 to 18.7% in the few studies identified. No RWE was identified to support management decisions for stable patients in Year 5 or later. Views among the group were also diverse on this question and voting on expert opinion statements was required. Only two studies reported the administration of additional courses of CladT, but detailed safety outcomes were not provided. CONCLUSIONS: RWE for the long-term use of CladT in the treatment of RMS is increasing, however, gaps in knowledge remain. Where possible, the RWE identified through the SLR informed expert statements, but, where RWE is still lacking, these were based solely on experiences and opinion, providing some guidance on topics and questions that occur in daily clinical practice. More real-world studies with longer-term follow-up periods are needed and highly anticipated.
BACKGROUND: In Africa, no cerebral aneurysm treatment guidelines exist. Epidemiology, management, and outcomes after aneurysmal subarachnoid hemorrhage (aSAH) remain poorly understood, with many underdiagnosed cases. Muhimbili Orthopaedic and Neurosurgery Institute (MOI) is the only neurosurgical referral center in Tanzania. The aim of this study is to describe the current aSAH management with regional outcomes and limitations. METHODS: Patients with aSAH confirmed by computed tomography/magnetic resonance angiography between February 2019 and June 2021 were retrospectively studied. The analyzed parameters included demographics, clinical/radiologic characteristics, injury characteristics, and the modified Rankin Scale (mRS) score. RESULTS: In total, 22 patients, with a female/male ratio of 1.4 and a median age of 54 years (interquartile range [IQR], 47.2-63 years) harboring 24 aneurysms were analyzed. Thirteen patients (59.1%) paid out of pocket. The median distance traveled by patients was 537 km (IQR, 34.7-635 km). The median time between admission and treatment was 12 days (IQR, 3.2-39 days). The most common symptoms were headache (n = 20; 90.9%) and high blood pressure (n = 10; 45.4%). Nine patients (40.9%) had Fisher grade 1 and 12 (54.5%) World Federation of Neurosurgical Societies grade I. The most common aneurysms were of the middle cerebral artery (7/29.2%). Fourteen patients (63.6%) underwent clipping; of those, only 4 (28.6%) were operated on within 72 hours. Mortality was 62.5% in the nonsurgical group. Among clipped patients, 78.6% showed favorable outcomes, with no mortality. Endovascular treatment is not available in Tanzania. CONCLUSIONS: To our best knowledge, this is the first study highlighting aSAH management in Tanzania, with its assets and shortcomings. Our data show pertinent differences among international treatment guidelines, with the resultant outcomes, such as high preoperative mortality resulting from delayed/postponed treatment. Regional difficult circumstances notwithstanding, our long-term goal is to significantly improve the overall management of aSAH in Tanzania.
- MeSH
- Intracranial Aneurysm * surgery MeSH
- Middle Aged MeSH
- Humans MeSH
- Neurosurgery * MeSH
- Orthopedics * MeSH
- Retrospective Studies MeSH
- Subarachnoid Hemorrhage * diagnostic imaging surgery MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Tanzania MeSH
Kriemler, Susi, Kastė Mateikaitė-Pipirienė, Alison Rosier, Linda E. Keyes, Peter Paal, Marija Andjelkovic, Beth A. Beidleman, Mia Derstine, Jacqueline Pichler Hefti, David Hillebrandt, Lenka Horakova, and Dominique Jean; for the UIAA MedCom Writing Group on Women's Health in the Mountains. Frostbite and mortality in mountaineering women: a scoping review-UIAA Medical Commission recommendations. High Alt Med Biol. 24:247-258, 2023. Background: The harsh environment of high altitudes (HA) poses many serious health risks for mountaineers, including cold injuries and death. The aim of this work was to review whether female mountaineers are at special risk for frostbite or death at HA compared with their male counterparts. Methods: The UIAA Medical Commission convened an international author team to review women's health issues at HA and to publish updated recommendations. Pertinent literature from PubMed and Cochrane was identified with additional publications found by hand search. The primary search focus was for articles assessing cold injuries and death in women mountaineers at HA. Results: We reviewed the literature and identified 20 relevant studies: 2 studies on frostbite at HA, plus 7 studies and 1 report for death at HA. An additional 10 studies about frostbite at low altitude were included. We found that female mountaineers at HA were at lower risk of death than their male counterparts, but sex differences in frostbite were inconclusive. Conclusions: The frequency of cold injuries and mortality in female mountaineers is not yet well studied, and the studies that have been published tend to lack precise exposure data. More studies and registries with sex-differentiated data are needed.
Koncept farmaceutické péče (FP) existuje jako profesní filozofie již více než 30 let, nicméně po dlouhou dobu bylo pro jeho začlenění do běžné praxe poskytování zdravotní péče učiněno jen málo. Pandemie COVID-19 a s ní spojený zvýšený příliv pacientů do veřejných lékáren (VL) podnítily zkoumání a zavádění nových zdravotnických služeb poskytovaných v rámci VL. Přesto jsou tyto služby lékárenské péče stále nové a pro rozšíření současné role komunitních lékárníků v primární zdravotní péči lze udělat více. Toho lze dosáhnout zlepšením a rozšířením nově zavedených služeb a zároveň začleněním nových služeb ve prospěch veřejného zdraví a snížení výdajů na zdravotní péči, kterým se lze vyhnout. Přestože farmaceutická péče (FP) existuje jako profesní filozofie od roku 1990, pro její začlenění do běžné praxe poskytování zdravotní péče bylo učiněno jen málo. Tento článek přináší přehled informací o přínosech této služby, pokud jde o zdraví pacientů a snížení finančních výdajů souvisejících s nežádoucími účinky léčivých přípravků v prostředí VL. Nežádoucí účinky jsou příčinou značných výdajů na zdravotní péči a potíží pacientů v důsledku příslušných symptomů, návštěv lékaře na pohotovosti a zvýšené míry hospitalizace. Několik studií provedených v mezinárodním měřítku zkoumalo pozitivní dopad farmaceutické péče, kterou vykonávají lékárníci ve VL. Navzdory výsledkům, které někdy vykazují nesouvislý průběh, má FP uplatňovaná za specifických podmínek hmatatelné pozitivní výsledky. U pacientů s městnavým srdečním selháním a diabetes mellitus 2. typu bylo zaznamenáno méně hospitalizací, lepší kontrola symptomů a vyšší adherence ve srovnání s kontrolními skupinami, zatímco studie na pacientech s astmatem odhalila zlepšení inhalačních technik. Všechny intervenční skupiny uváděly zlepšení psychického stavu a lepší porozumění léčbě. Zvláštní zmínka je věnována významu této služby pro pacienty podstupující protinádorovou léčbu a skutečnosti, že lékárníci ve VL mohou hrát klíčovou roli při navrhování, monitorování a změně návrhu těchto léčebných schémat, jejichž složitost a související nežádoucí účinky léčivých přípravků negativně ovlivňují adherenci pacientů. Úloha komunitních lékárníků byla během pandemie velmi důležitá, zejména pro primární péči, a to jak pro pacienty, tak pro systémy zdravotní péče, a zdá se, že bude rozhodující i v období po skončení pandemie. Zvýšená složitost terapie a polyfarmacie vytváří potřebu organizované a aktivní účasti lékárníků na poskytování zdravotní péče tak, aby mohli využívat své znalosti a dovednosti při kontinuální spolupráci s ostatními zdravotnickými pracovníky, a poskytovat tak koordinované služby ve prospěch pacienta.
The concept of pharmaceutical care (PC) has existed as a professional philosophy for more than 30 years. However, for a long period of time, little had been done for its integration into the regular practice of healthcare provision. The COVID-19 pandemic and the resulting increase in patient influx in the community pharmacies (CP) encouraged the exploration and establishment of new healthcare services provided within the CP. Nevertheless, these services of PC are still novel, and more can be done to expand the community pharmacists’ current role in primary healthcare. This can be achieved by improving and expanding the newly established services, all while incorporating new ones, for the benefit of public health and the reduction of avoidable healthcare expenditures. This article reviews information about the benefits of this service regarding patient health and the reduction of financial expenses pertinent to adverse drug events within the setting of the CP. Adverse drug events account for significant healthcare expenses and patient distress due to relevant symptoms, emergency doctor visits, and increased hospitalization rates. Several studies conducted internationally have investigated the positive impact of PC practiced by community pharmacists. In spite of results sometimes presenting a non-continuous pattern, PC applied under specific conditions has tangible positive outcomes. Congestive heart failure and type 2 diabetes mellitus patients presented fewer hospital admissions, better symptom control, and higher adherence in comparison to control groups, while a study on asthma patients revealed improved inhalation techniques. All intervention groups reported psychological improvement and a better understanding of their treatment. Special reference is made to the importance of this service for patients receiving anti-cancer treatment and how community pharmacists can have a crucial role in designing, monitoring, and re-designing these therapeutic schemes whose complexity and related adverse drug events negatively affect patient adherence. The role of community pharmacists was very important, especially for primary care, for both patients and healthcare systems during the pandemic, and it seems that it will remain decisive in the post-COVID era as well. The increased complexity of therapy and polypharmacy creates the need for organized, active participation of pharmacists in healthcare provision so that they can use their knowledge and skills under continuous cooperation with other healthcare professionals, thus providing coordinated services for the benefit of the patient.
BACKGROUND: PERTINENT is an active hospital-based surveillance system for pertussis in infants. In 2019, four of the six participating European countries recommended pertussis vaccination in pregnancy. Among infants aged <2 months, we measured the vaccine effectiveness (VE) in pregnancy; among infants aged 2-11 months, VE of vaccination in pregnancy and of primary vaccination (PV). METHODS: From December 2015 to 2019, we included all infants aged <1 year presenting with pertussis-like symptoms. Using a test-negative-design, cases were infants testing positive for Bordetella pertussis by PCR or culture. Controls were those testing negative for all Bordetella species. Vaccinated mothers were those who received vaccine in pregnancy. Vaccinated infants were those who received ≥1 dose of PV > 14 days before symptom onset. We excluded infants with unknown maternal or PV status or with mothers vaccinated ≤14 days before delivery. We calculated pooled VE as 100 * (1-odds ratio of vaccination) adjusted for study site, onset date in quarters and infants' age group. RESULTS: Of 829 infants presenting with pertussis-like symptoms, 336 (41%) were too young for PV. For the VE in pregnancy analysis, we included 75 cases and 201 controls. Vaccination in pregnancy was recorded for 9 cases (12%) and 92 controls (46%), adjusted VE was between 75% [95%CI: 35-91%] and 88% [95%CI: 57-96%]. Of 493 infants eligible for PV, we included 123 cases and 253 controls. Thirty-one cases and 98 controls recorded both PV with ≥ 1 dose and vaccination in pregnancy, adjusted VE was between 74% [95%CI: 33-90] and 95% [95%CI: 69-99]; 27 cases and 53 controls recorded PV only, adjusted VE was between 68% [95%CI: 27-86] and 94% [95%CI: 59-99]. CONCLUSION: Our findings suggest that vaccination in pregnancy reduces pertussis incidence in infants too young for PV. In infants aged 2-11 months, PV only and both PV and vaccination in pregnancy provide significant protection against severe pertussis.
- MeSH
- Hospitalization MeSH
- Humans MeSH
- Mothers MeSH
- Whooping Cough * epidemiology MeSH
- Pertussis Vaccine MeSH
- Case-Control Studies MeSH
- Pregnancy MeSH
- Vaccination MeSH
- Check Tag
- Humans MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
