Project description:Dentistry has entered an era of personalized/precision care in which targeting care to groups, individuals, or even tooth surfaces based on their caries risk has become a reality to address the skewed distribution of the disease. The best approach to determine a patient's prognosis relies on the development of caries risk prediction models (CRPMs). A desirable model should be derived and validated to appropriately discriminate between patients who will develop disease from those who will not, and it should provide an accurate estimation of the patient's absolute risk (i.e., calibration). However, evidence suggests there is a need to improve the methodological standards and increase consistency in the way CRPMs are developed and evaluated. In fact, although numerous caries risk assessment tools are available, most are not routinely used in practice or used to influence treatment decisions, and choice is not commonly based on high-quality evidence. Research will propose models that will become more complex, incorporating new factors with high prognostic value (e.g., human genetic markers, microbial biomarkers). Big data and predictive analytic methods will be part of the new approaches for the identification of promising predictors with the ability to monitor patients' risk in real time. Eventually, the implementation of validated, accurate CRPMs will have to follow a user-centered design respecting the patient-clinician dynamic, with no disruption to the clinical workflow, and needs to operate at low cost. The resulting predictive risk estimate needs to be presented to the patient in an understandable way so that it triggers behavior change and effectively informs health care decision making, to ultimately improve caries outcomes. However, research on these later aspects is largely missing and increasingly needed in dentistry.
Project description:Prioritization of diversity, equity, and inclusion in all facets of our work is long overdue for the clinical pharmacology community. Increasing diversity in clinical research will deepen our understanding of nuanced patient populations and help improve all patient outcomes. Fostering an inclusive and diverse workforce will lead to broader perspectives that can better inform critical decisions and create work environments where everyone can thrive. In this call to action, we invite you to join us.
Project description:Worldwide, lifestyle and resource disparities among adolescents contribute to unmet health needs, which have crucial present and future public health implications for both adolescents and broader communities. Risk of infection among adolescents is amplified by biological, behavioral, and environmental factors; however, infectious diseases to which adolescents are susceptible are often preventable with vaccines. Beyond these concerns, there is a lack of knowledge regarding adolescent vaccination and disease risk among parents and adolescents, which can contribute to low vaccine uptake. Promising efforts have been made to improve adolescent vaccination by programs with motivational drivers and comprehensive communication with the public. In May 2017, a multidisciplinary group of experts met in Amsterdam, Netherlands, to discuss adolescent vaccine uptake, as part of an educational initiative called the Advancing Adolescent Health Spring Forum. This article presents consensus opinions resulting from the meeting, which pertain to the burden of vaccine-preventable diseases among adolescents, reasons for low vaccine uptake, and common characteristics of successful strategies for improving adolescent vaccination.Conclusion: There is an urgent "call to action," particularly targeting healthcare providers and public health authorities, for the prioritization of adolescent vaccination as a necessary element of preventive healthcare in this age group.What is Known:• Despite increased risk of certain infectious diseases, adolescent vaccination uptake remains low.What is New:• Barriers to adolescent vaccine uptake include lack of information regarding vaccines and disease risk, health system inadequacies, and insufficient healthcare follow-up.• Successful efforts to improve adolescent vaccine uptake need cohesive leadership and involvement of multiple stakeholders, as well as youth-friendly messaging; healthcare providers and policymakers should prioritize adolescent vaccination and implement proven program strategies to improve adolescent health worldwide.
Project description:The oversupply of postdoctoral scholars relative to available faculty positions has led to calls for better assessment of career outcomes. Here, we report the results of a study of postdoctoral outcomes at the University of California, San Francisco, and suggest that institutions have an obligation to determine where their postdoc alumni are employed and to share this information with current and future trainees. Further, we contend that local efforts will be more meaningful than a national survey, because of the great variability in training environment and the classification of postdoctoral scholars among institutions. We provide a framework and methodology that can be adopted by others, with the goal of developing a finely grained portrait of postdoctoral career outcomes across the United States.
Project description:BackgroundHypertension is a leading cause of cardiovascular disease (CVD) and affects nearly one in two adults in the United States when defined as a blood pressure of at least 130/80 mm Hg or on antihypertensive medication (Virani et al., 2021, Circulation, 143, e254). Long-standing disparities in hypertension awareness, treatment, and control among racial and ethnic populations exist in the United States. High-quality evidence exists for how to prevent and control hypertension and for the role nurses can play in this effort. In response to the 2020 Surgeon General's Call to Action to Control Hypertension, nursing leaders from 11 national organizations identified the critical roles and actions of nursing in improving hypertension control and cardiovascular health, focusing on evidence-based nursing interventions and available resources.AimsTo develop a unified "Call to Action for Nurses" to improve control of hypertension and cardiovascular health and provide information and resources to execute this call.MethodsThis paper outlines roles that registered nurses, advanced practice nurses, schools of nursing, professional nursing organizations, quality improvement nurses, and nursing researchers can play to control hypertension and prevent CVD in the United States. It describes evidence-based interventions to improve cardiovascular health and outlines actions to bring hypertension and CVD to the forefront as a national priority for nursing.Linking evidence to actionEvidence-based interventions exist for nurses to lead efforts to prevent and control hypertension, thus preventing much CVD. Nurses can take actions in their communities, their healthcare setting, and their organization to translate these interventions into real-world practice settings.
Project description:ObjectivesBiologic therapies are emerging as an option to treat a subset of patients with severe asthma, however no direct comparison between these agents has been conducted. Furthermore, heterogeneity of outcomes in clinical trials makes it difficult to compare these agents and traditional therapies. The extent to which this heterogeneity exists has major implications for evidence-based decisions and is yet to be fully reported. We conducted a literature search to examine outcomes currently being used in clinical trials for asthma.Data sourcesThe Cochrane Library and Clinicaltrials.gov were searched for clinical trials of asthma interventions.Study selectionsWe limited our search to phase 2 through 4 clinical trials in adults, as early-phase trials tend to have pharmacodynamic and pharmacokinetic endpoints as primary outcomes. Interventions for acute exacerbations were excluded.ResultsWe identified 117 studies and subsequently identified 111 outcomes. The most prevalent outcomes were asthma control and symptom severity, FEV1, and change in ACQ scale. Twenty patient-reported outcomes instruments were identified and de-facto standard asthma outcomes and PROs were under-reported in examined literature. Existing quality of life tools did not capture the day-to-day experience or the unique treatment burden from oral corticosteroids for patient with severe asthma. Compounding the absence of trials directly comparing therapies, the significant variation we identified in outcome definitions and measurement create hurdles to effectively compare traditional and biologic therapies.ConclusionWith the growing number of clinical trials evaluating advanced therapies such as biologics, a wide range of primary and secondary outcomes are evaluated. A core outcome set created by relevant stakeholders is needed to collectively evaluate pooled outcomes in order to allow more meaningful comparisons of asthma therapies and to incorporate the patient experience.
Project description:This article highlights the importance of diphtheria-tetanus-acellular pertussis (with reduced antigen content, dTap) vaccination in preventing pertussis, a respiratory infection that is still widespread and easily transmitted. In particular, it highlights the need to receive a booster vaccination throughout life to maintain high antibody levels, which decrease through time. This document collects the opinions that emerged from the comparison between major Italian experts in the field of vaccination. This working group was created to promote a "call to action", aimed at raising awareness among all institutions, public health authorities, and health workers involved in the vaccination process, about the importance of dTap vaccine administration and with the mindset of implementing the strategic vaccination plan provided by the National Vaccine Plan (NVP). In fact, despite this vaccine being included in the NVP, there are some issues attributable to the practice of vaccination (local health authorities, vaccination centers, occupational health services, gynecology centers, societies of work). Therefore, it is necessary that the Ministry defines the vaccination coverage objectives, identifies the groups of subjects who should receive the booster vaccine (subjects exposed to greater risk of infection, subjects over 60, pregnant women), and applies all the necessary measures to encourage the implementation of this practice.
Project description:Coronavirus disease 2019 (COVID-19) has affected more than 96 million people worldwide, leading the World Health Organization (WHO) to declare a pandemic in March 2020. Although an optimal medical treatment of COVID-19 remains uncertain, an unprecedented global effort to develop an effective vaccine hopes to restore pre-pandemic conditions. Since cancer patients as a group have been shown to be at a higher risk of severe COVID-19, the development of safe and effective vaccines is crucial. However, cancer patients may be underrepresented in ongoing phase 3 randomised clinical trials investigating COVID-19 vaccines. Therefore, we encourage stakeholders to provide real-time data about the characteristics of recruited participants, including clearly identifiable subgroups, like cancer patients, with sample sizes large enough to determine safety and efficacy. Moreover, we envisage a prompt implementation of suitable registries for pharmacovigilance reporting, in order to monitor the effects of COVID-19 vaccines and immunisation rates in patients with cancer. That said, data extrapolation from other vaccine trials (e.g. anti-influenza virus) showed a favourable safety and efficacy profile for cancer patients. On the basis of the evidence discussed, we believe that the benefits of the vaccination outweigh the risks. Consequently, healthcare authorities should prioritise vaccinations for cancer patients, with the time-point of administration agreed on a case-by-case basis. In this regard, the American Society of Clinical Oncology and the European Society of Medical Oncology are advocating for cancer patients a high priority status, in the hope of attenuating the consequences of the pandemic in this particularly vulnerable population.
Project description:BackgroundComorbidities can complicate the management of severe asthma; therefore, the presence of comorbid conditions or traits often need to be considered when considering treatment options for patients with severe asthma. The aim of this analysis is to investigate the efficacy of mepolizumab in patients with severe eosinophilic asthma and comorbidities.MethodsThis was a post hoc analysis (GSK ID:209140) of data from the Phase IIb/III studies DREAM, MENSA, SIRIUS, and MUSCA. Patients aged ≥ 12 years with severe eosinophilic asthma were randomized to: mepolizumab 750, 250, or 75 mg intravenously or placebo (DREAM); mepolizumab 75 mg intravenously or 100 mg subcutaneously or placebo (MENSA); or mepolizumab 100 mg subcutaneously or placebo (SIRIUS and MUSCA) every 4 weeks for 24 weeks in SIRIUS and MUSCA, 32 weeks in MENSA or 52 weeks in DREAM. In this analysis the primary endpoint was the annual rate of clinically significant exacerbations; secondary endpoints were Asthma Control Questionnaire-5 score, St George's Respiratory Questionnaire total score, and pre-bronchodilator forced expiratory volume in 1 s at study end. Subgroups were based on comorbidities at baseline.ResultsOverall, 1878 patients received placebo (n = 689) or mepolizumab (n = 1189). Across all comorbidity subgroups mepolizumab reduced the rate of clinically significant exacerbations by 44-68% versus placebo, improved Asthma Control Questionnaire-5 score by 0.27-0.59 points, and improved St George's Respiratory Questionnaire total score by 5.0-11.6 points. Pre-bronchodilator forced expiratory volume in 1 s was improved by 27.1-286.9 mL in all but one comorbidity subgroup, the diabetes mellitus subgroup.ConclusionsMepolizumab reduces exacerbations, and improves asthma control, health-related quality of life, and lung function in patients with severe eosinophilic asthma despite comorbid conditions, including upper respiratory conditions, psychopathologies, cardiovascular conditions, gastroesophageal reflux disease, diabetes mellitus, and obesity.Trial registrationhttps://clinicaltrials.gov/ DREAM, MEA112997/NCT01000506; MENSA, MEA115588/NCT01691521; SIRIUS, MEA115575/NCT01842607; MUSCA, 200862/NCT02281318.
Project description:Traditional clinical trial eligibility criteria restrict study populations, perpetuating enrollment disparities. We aimed to assess implementation of modernized eligibility criteria guidelines among pancreatic cancer (PC) clinical trials. Interventional PC trials in the United States since January 1, 2014, were identified via clinicaltrials.gov with December 31, 2017, as the transition for pre- and postguidance eras. Trials were assessed for guideline compliance and compared using Fisher exact test. In total, 198 trials were identified: 86 (43.4%) were pre- and 112 (56.6%) postguidance era. Improvements were seen in allowing patients with history of HIV (8.6% vs 43.8%; P < .0001), prior cancer (57.0% vs 72.3%; P = .034), or concurrent and/or stable cancer (2.1% vs 31.1%; P < .0001) to participate. Most (>95%) trials were compliant with laboratory reference ranges, QT interval corrected for heart rate (QTc) cutoffs, and rationalizing excluding prior therapies both pre- and postguidance eras. However, overall compliance with modernized criteria remains poor. We advocate for stakeholders to update protocols and scrutinize traditionally restrictive eligibility criteria.