scholarly journals Safety and efficacy of cardiovascular medication in women and men; the added value of clinical care data

10.33540/720 ◽  
2021 ◽  
Author(s):  
◽  
Sophie Heleen Bots
2019 ◽  
Vol 5 (1) ◽  
pp. 00016-2019 ◽  
Author(s):  
Karlijn Hummelink ◽  
Mirte Muller ◽  
Theodora C. Linders ◽  
Vincent van der Noort ◽  
Petra M. Nederlof ◽  
...  

ObjectivesMolecular profiling of tumours has become the mainstay of diagnostics for metastasised solid malignancies and guides personalised treatment, especially in nonsmall cell lung cancer (NSCLC). In current practice, it is often challenging to obtain sufficient tumour material for reliable molecular analysis. Cell-free DNA (cfDNA) in blood or other bio-sources could present an alternative approach to obtain genetic information from the tumour. In a retrospective cohort we analysed the added value of cfDNA analysis in pleural effusions for molecular profiling.MethodsWe retrospectively analysed both the supernatant and the cell pellet of 44 pleural effusions sampled from 39 stage IV patients with KRAS (n=23) or EGFR (n=16) mutated tumours to detect the original driver mutation as well as for EGFR T790M resistance mutations. Patients were diagnosed with either NSCLC (n=32), colon carcinoma (n=4), appendiceal carcinoma (n=2) or adenocarcinoma of unknown primary (n=1). Samples collected in the context of routine clinical care were stored at the Netherlands Cancer Institute biobank. We used droplet digital PCR for analysis.ResultsThe driver mutation could be detected in 36 of the 44 pleural effusions by analysis of both the supernatant (35 out of 44 positive) and the cell pellet (31 out of 44 positive). In seven out of 20 pleural effusions from patients with EGFR mutation-positive tumours, a T790M mutation was detected. All seven supernatants and cell pellets were positive.ConclusionscfDNA in pleural effusion can be used to detect driver mutations as well as resistance mechanisms like EGFR T790M in pleural effusion with high accuracy and is therefore a valuable bio-source.


2020 ◽  
Vol 5 ◽  
pp. 13
Author(s):  
Paul Turner ◽  
Elizabeth A. Ashley ◽  
Olivier J. Celhay ◽  
Anousone Douangnouvong ◽  
Raph L. Hamers ◽  
...  

Background: Antimicrobial resistance (AMR) / drug resistant infections (DRIs) are a major global health priority. Surveillance data is critical to inform infection treatment guidelines, monitor trends, and to assess interventions. However, most existing AMR / DRI surveillance systems are passive and pathogen-based with many potential biases. Addition of clinical and patient outcome data would provide considerable added value to pathogen-based surveillance. Methods: The aim of the ACORN project is to develop an efficient clinically-oriented AMR surveillance system, implemented alongside routine clinical care in hospitals in low- and middle-income country settings. In an initial pilot phase, clinical and microbiology data will be collected from patients presenting with clinically suspected meningitis, pneumonia, or sepsis. Community-acquired infections will be identified by daily review of new admissions, and hospital-acquired infections will be enrolled during weekly point prevalence surveys, on surveillance wards. Clinical variables will be collected at enrolment, hospital discharge, and at day 28 post-enrolment using an electronic questionnaire on a mobile device. These data will be merged with laboratory data onsite using a flexible automated computer script. Specific target pathogens will be Streptococcus pneumoniae, Staphylococcus aureus, Salmonella spp., Klebsiella pneumoniae, Escherichia coli, and Acinetobacter baumannii. A bespoke browser-based app will provide sites with fully interactive data visualisation, analysis, and reporting tools. Discussion: ACORN will generate data on the burden of DRI which can be used to inform local treatment guidelines / national policy and serve as indicators to measure the impact of interventions. Following development, testing and iteration of the surveillance tools during an initial six-month pilot phase, a wider rollout is planned.


BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e023810 ◽  
Author(s):  
Tine Van Bortel ◽  
Nuwan Darshana Wickramasinghe ◽  
Antony Morgan ◽  
Steven Martin

ObjectiveTo provide an up-to-date overview of health assets in a global context both from a theoretical perspective and its practical applications to address health inequalities and achieve sustainable health.DesignA systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Data sourcesA comprehensive search, including 10 electronic bibliographic databases and hand searches, was undertaken to capture the wide range of terms associated with ‘health assets’ and ‘asset-based approaches to health’.Eligibility criteriaAny peer-reviewed published and grey literature in English related to ‘health assets’ or ‘assets’ in a ‘health’ context was included without any date, country or study design restrictions and the quality of evidence was appraised according to the Oxford Level of Evidence.OutcomesA broad consideration of all outcome measures including clinical outcomes, patient-level, community-level and population-level impacts and costs, was adopted.Results478 publications were included. Health assets were researched in 40 countries, predominantly in the West such as the USA and the UK. A number of broad health assets were identified including community and individual assets. Even though research was conducted in a number of different settings, most occurred in the community, clinical, care or educational settings. A wide variety of interventions and approaches were implemented, most commonly related to education and/or training, asset mapping or asset approaches.ConclusionsGlobally, authors most often referred to general ‘health assets’, ‘assets’ or some form of ‘community asset’ in relation to health. Overall, the idea of health assets is framed within a positive paradigm focusing on health creation rather than curative approaches. The sustained credibility of the global ‘health assets’ literature depends on future research on definitional, theoretical and evaluative issues in order to convince policy-makers and service commissioners of its necessity and added value to the traditional deficit approach.


2017 ◽  
Vol 34 (08) ◽  
pp. 826-832 ◽  
Author(s):  
Laura Riley ◽  
Alison Cahill ◽  
Richard Beigi ◽  
Renate Savich ◽  
George Saade

AbstractIn February 2015, given high rates of use of medications by pregnant women and the relative lack of data on safety and efficacy of many drugs utilized in pregnancy, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Society for Maternal-Fetal Medicine (SMFM), the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Pediatrics (AAP) convened a group of experts to review the “current” state of the clinical care and science regarding medication use during the perinatal period. The expert panel chose select medications to demonstrate what existing safety and efficacy data may be available for clinicians and patients when making decisions about use in pregnancy or lactation. Furthermore, these example medications also provided opportunities to highlight where data are lacking, thus forming a list of research gaps. Last, after reviewing the existing vaccine safety surveillance system as well as the legislative history surrounding the use of drugs for pediatric diseases, the expert panel made specific recommendations concerning policy efforts to stimulate more research and regulatory attention on drugs for pregnant and lactating women.


2020 ◽  
Vol 5 ◽  
pp. 13 ◽  
Author(s):  
Paul Turner ◽  
Elizabeth A. Ashley ◽  
Olivier J. Celhay ◽  
Anousone Douangnouvong ◽  
Raph L. Hamers ◽  
...  

Background: Antimicrobial resistance (AMR) / drug resistant infections (DRIs) are a major global health priority. Surveillance data is critical to inform infection treatment guidelines, monitor trends, and to assess interventions. However, most existing AMR / DRI surveillance systems are passive and pathogen-based with many potential biases. Addition of clinical and patient outcome data would provide considerable added value to pathogen-based surveillance. Methods: The aim of the ACORN project is to develop an efficient clinically-oriented AMR surveillance system, implemented alongside routine clinical care in hospitals in low- and middle-income country settings. In an initial pilot phase, clinical and microbiology data will be collected from patients presenting with clinically suspected meningitis, pneumonia, or sepsis. Community-acquired infections will be identified by daily review of new admissions, and hospital-acquired infections will be enrolled during weekly point prevalence surveys, on surveillance wards. Clinical variables will be collected at enrolment, hospital discharge, and at day 28 post-enrolment using an electronic questionnaire on a mobile device. These data will be merged with laboratory data onsite using a flexible automated computer script. Specific target pathogens will be Streptococcus pneumoniae, Staphylococcus aureus, Salmonella spp., Klebsiella pneumoniae, Escherichia coli, and Acinetobacter baumannii. A bespoke browser-based app will provide sites with fully interactive data visualisation, analysis, and reporting tools. Discussion: ACORN will generate data on the burden of DRI which can be used to inform local treatment guidelines / national policy and serve as indicators to measure the impact of interventions. Following development, testing and iteration of the surveillance tools during an initial six-month pilot phase, a wider rollout is planned.


2020 ◽  
Vol 47 (12) ◽  
pp. 1822-1830
Author(s):  
Shanthini Kasturi ◽  
John B. Wong ◽  
Lisa A. Mandl ◽  
Timothy E. McAlindon ◽  
Amy LeClair

ObjectiveTo identify rheumatologists’ views on perceived barriers and facilitators to the clinical implementation of patient-reported outcome measures (PROM).MethodsSemistructured interviews were conducted with academically affiliated clinical rheumatologists. Interviews were audio-recorded and transcribed. Deidentified transcripts were independently coded and analyzed for themes.ResultsFifteen attending rheumatologists, 8 women (53%) and 7 men (47%) with a mean of 17.3 years in practice (range 5–43) at 2 urban academic medical centers, participated in interviews. Rheumatologists identified several barriers to integrating PROM in clinical care, highlighting physician buy-in and culture change as significant challenges beyond logistical considerations. They further underscored the lack of effective interventions and resources for addressing the domains of most interest to patients. Physicians also recognized significant benefits of PROM in clinical care, including contributing to the clinical impression by providing the patient perspective, and promoting agenda setting by uncovering “unspoken questions.” They additionally noted that PROM could support treatment planning, build patient-physician relationships, and facilitate patient engagement. Participants suggested that technology, physician education, and team-based care could facilitate the effective implementation of PROM.ConclusionRheumatologists identified multiple mechanisms through which PROM could augment clinical care, but also noted several obstacles to implementation, questioning the added value of PROM and the limited availability of interventions to improve patient-centered outcomes. Programs seeking to successfully integrate PROM to enhance patient-centered care and meet quality benchmarks should prioritize physician buy-in and training, and provide resources to address the outcomes that are measured.


2021 ◽  
Author(s):  
Jordi Heijman ◽  
Henry Sutanto ◽  
Harry J G M Crijns ◽  
Stanley Nattel ◽  
Natalia A Trayanova

Abstract Despite significant advances in its detection, understanding and management, atrial fibrillation (AF) remains a highly prevalent cardiac arrhythmia with major impact on morbidity and mortality of millions of patients. AF results from complex, dynamic interactions between risk factors and comorbidities that induce diverse atrial remodeling processes. Atrial remodeling increases AF vulnerability and persistence, while promoting disease progression. The variability in presentation and wide range of mechanisms involved in initiation, maintenance and progression of AF, as well as its associated adverse outcomes, make the early identification of causal factors modifiable with therapeutic interventions challenging, likely contributing to suboptimal efficacy of current AF management. Computational modeling facilitates the multilevel integration of multiple datasets and offers new opportunities for mechanistic understanding, risk prediction and personalized therapy. Mathematical simulations of cardiac electrophysiology have been around for 60 years and are being increasingly used to improve our understanding of AF mechanisms and guide AF therapy. This narrative review focuses on the emerging and future applications of computational modeling in AF management. We summarize clinical challenges that may benefit from computational modeling, provide an overview of the different in silico approaches that are available together with their notable achievements, and discuss the major limitations that hinder the routine clinical application of these approaches. Finally, future perspectives are addressed. With the rapid progress in electronic technologies including computing, clinical applications of computational modeling are advancing rapidly. We expect that their application will progressively increase in prominence, especially if their added value can be demonstrated in clinical trials.


2021 ◽  
pp. 019459982110042
Author(s):  
Ralph Haddad ◽  
Nadim Khoueir ◽  
Hussein Smaily ◽  
Simon Rassi ◽  
Walid Abou Hamad

Objectives To systematically review the literature to evaluate the indications, safety, and efficacy of the Draf IIb procedure and to evaluate the added advantages of technical factors such as stents and flaps. Data Sources Articles published until July 2019 on Medline and Cochrane databases. Review Methods After a systematic review based on the 2018 PRISMA guidelines was conducted, 26 of 1533 articles were included and reviewed for indications of Draf IIb; surgical technique; use of flaps, stents, grafts, or mitomycin; complications during and after surgery; and success or recurrence rate. Results The main indication for Draf IIb was chronic frontal rhinosinusitis (61.82%). The postoperative patency rate was 87.85%. When flaps/grafts were applied, the rate was 93.5%, but their added value was not statistically significant. Stents could be an alternative for revision surgery. Treating frontal pathologies other than chronic rhinosinusitis was also satisfying. Safety was comparable to Draf III: no perioperative complications were reported, only a few postoperative ones (eyelid ecchymosis and periorbital cellulitis in 0.2% of the cases, hyposmia in 1.55%). Conclusion When properly indicated, Draf IIb frontal drilling is a safe and highly effective surgical technique for frontal pathology treatment, with efficiency and safety comparable to the Draf III, making it a valid option when a bilateral approach is not needed. More studies are required to confirm the added values of flaps, grafts, and stents.


Author(s):  
Frances Sissamis ◽  
Karina Villalba ◽  
Jordan Garcia ◽  
Vickie Melus ◽  
Emily J. Markentell ◽  
...  

Religion can have a favorable impact on individual-level health. The influence of religion on population health, however, remains less clear. This study investigated the association between religion and mortality at the population-level. Using county data, a meta-regression was performed to examine between-county mortality heterogeneity. The percent heterogeneity associated with religion variables were compared to demographics (i.e., place, race, language, age, and gender) and health factors (i.e., individual behaviors, clinical care, social and economic, and physical environment) as predictors of mortality. Religion was measured in terms of adherence (i.e., prevalence attending/belonging to a congregation), congregation density, and the diversity of adherents and congregation by denominations. Results showed counties with lower mortality were associated with higher proportions of religion adherents and a greater diversity of adherents and congregations. Counties with higher mortality were associated with higher religion congregation density. Religion, as a parsimonious multivariate model with all demographic and health factor predictors, had less added value when controlled for individual variables or constructs. The direction of association between religion and mortality was consistent, even when controlling for demographics and health factors, and thus merits further consideration as a population health determinant, as it may play a critical role in understanding other population health outcomes.


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