Risk of venous thromboembolism among women receiving ospemifene: a comparative observational study.

Introduction: The primary aim of this study was to compare the incidence of venous thromboembolism (VTE) among women initiating ospemifene vs other selective estrogen receptor modulator (SERM) therapies for estrogen-deficiency conditions or breast cancer prevention, and vs women with untreated vulvar and vaginal atrophy (VVA). The secondary objective examined numerous additional safety outcomes. Methods: This was a retrospective cohort study using the IBM Watson MarketScan claims database. Women receiving ospemifene, another SERM, or with a new diagnosis of VVA with no treatment from 1 May 2013 to 2 October 2018 were followed through the claims for incident adverse outcomes. The primary outcome was the first occurrence of VTE following cohort entry; secondary outcomes included cerebrovascular events and other adverse events potentially associated with SERM use. Cox models compared the risk of VTE between ospemifene and comparators, using a variety of approaches to control for confounding. Results: The incidence of VTE during the first continuous treatment episode was 3.39 (95% confidence interval [CI]: 1.55-6.43) events per 1,000 person-years (PY) for ospemifene (N = 8977), 11.30 (95% CI: 8.81-14.28) events per 1,000 PY for comparator SERM (N = 12,621), and 10.92 (95% CI: 10.49-11.37) events per 1,000 PY for untreated VVA (N = 242,488). Cox models indicated no increase in risk of VTE for ospemifene vs other SERMs (hazard ratio [HR]: 0.40, 95% CI: 0.19-0.82), and vs untreated VVA (HR: 0.47, 95% CI: 0.24-0.91). Conclusion: This real-world safety analysis found no increase in risk of VTE or other adverse events with use of ospemifene in postmenopausal women. Plain Language Summary: Introduction: This study assessed the risk of venous thromboembolism (VTE) among women treated with ospemifene or another selective estrogen receptor modulator (SERM) therapy and women with untreated vulvar and vaginal atrophy (VVA). Numerous additional safety outcomes were examined.Methods: This study was conducted in the IBM Watson MarketScan claims database. Women receiving ospemifene, another SERM, or with a new diagnosis of VVA with no treatment from 1 May 2013 to 2 October 2018 were followed through the claims for adverse outcomes, including VTE, cerebrovascular events (such as stroke), and other outcomes that might occur with use of a SERM. The analyses compared the risk of VTE between ospemifene and the other two groups, using methods that accounted for differences in patient characteristics between the groups. Because few women over 72 years old used ospemifene, the main analyses examined women aged 54-72 years.Results: The analyses included 8,977 ospemifene users, 12,621 other SERM users, and 242,488 women with untreated VVA. Among women aged 54-72 years, only 9 experienced a VTE during ospemifene treatment, while 55 other SERM users and 1,788 women with untreated VVA had a VTE. The analyses that accounted for differences between the groups confirmed that the risk of VTE was no higher in ospemifene users than in either comparison group.Conclusion: This real-world safety analysis found no increase in risk of VTE or other adverse events with use of ospemifene in postmenopausal women.

Addressing Code Red for humans and the planet: We are in this together.

Climate change is one of the greatest threats to human health. It is not surprising that following one of the hottest years on record (2019) and wildfires on almost all continents that the 2021 Intergovernmental Panel on Climate Change and the 2021 Lancet Countdown on Climate Change identified a Code Red for humanity and for a healthy future. In addition, just prior to the November 2021 Conference of the Parties (COP26), the World Health Organization released its Special Report, The Health Argument for Climate Action, in which the global health community provided 10 recommendations for policymakers and governments for greener, cleaner and more sustainable action to ensure a healthy and just future. There is thus an urgent need for socially and environmentally accountable health professions education to pick up the pace in terms of climate change, planetary health and/or sustainable health care integration in curricula. Considerable work has already been undertaken by faculty and students. As we are in this together, students and faculty can collaborate and build upon the work already undertaken to ensure universities are social and environmentally accountable.

Harmonizing allergy care-integrated care pathways and multidisciplinary approaches.

There is a wide time gap between the publication of evidence and the application of new knowledge into routine clinical practice. The consequence is sub-optimal outcomes, particularly concerning for long-term relapsing/remitting conditions such as allergic diseases. In response, there has been a proliferation of published guidelines which systematically review evidence for the gold-standard management of most allergic disorders. However, this has not necessarily been followed by improved outcomes, partly due to a lack of coordination across the patient pathway. This has become known as the "second translational gap". A proposed solution is the development and implementation of integrated care pathways (ICPs) to optimize patient outcomes, with the notion that evidence-based medicine requires evidence-based implementation. ICP implementation is shown to improve short-term outcomes for acute conditions and routine surgery, including reduced length of hospital stay, improved documentation and improved patient safety. However, this improvement is not reflected in patient experience or patient-centered functional outcomes. The implementation of life-long, cost-effective interventions within comprehensive pathways requires a deep appreciation for complexity within allergy care. We promote an evidence-based methodology for the implementation of ICPs for allergic disorders in which all stakeholders in allergy care are positioned equally and encouraged to contribute, particularly patients and their caregivers. This evidence-based process commences with scoping the unmet needs, followed by stakeholder mapping. All stakeholders are invited to meetings to develop a common vision and mission through the generation of action/effect diagrams which helps build concordance across the agencies. Dividing the interventions into achievable steps and reviewing with plan/do/study/act cycles will gradually modify the pathway to achieve the best outcomes. While the management guidelines provide the core knowledge, the key component of implementation involves education, training, and support of all healthcare professionals (HCPs), patients and their caregivers. The pathways should define the level of competence required for each clinical task. It may be useful to leave the setting of care delivery or the specific HCP involved undefined to account for variable patterns of health service delivery as well as local socioeconomic, ethnic, environmental, and political imperatives. In all cases, where competence is exceeded, it is necessary to refer to the next stage in the pathway. The success and sustainability of ICPs would ideally be judged by patient experience, health outcomes, and health economics. We provide examples of successful programs, most notably from Finland, but recommend that further research is required in diverse settings to optimize outcomes worldwide.

Allergy education and training for physicians.

The increasing prevalence of allergic diseases has placed a significant burden on global healthcare and society as whole. This has necessitated a rapid development of "allergy" as a specialist area. However, as allergy is so common and, for most, relatively easy to diagnose and control, all clinicians need to have basic knowledge and competence  to manage  mild disease and recognize when referral is required. The allergology specialty has not yet been recognized in many countries and even where allergy is fully recognized as a specialty, the approach to training in allergy differs significantly. In the light of recent developments in allergy diagnosis and management, there is an urgent need to harmonize core competences for physicians, as well as the standardization of core principles for medical education and post-graduate training in allergy. All physicians and allied health professionals must appreciate the multidisciplinary team (MDT) approach to allergy, which is key to achieving the highest standards in holistic care. Due to worldwide variation in resources and personnel, some MDT roles will need to be absorbed by the treating physician or other healthcare professionals. We draw particular attention to the role of psychological input for all allergy patients, dietetic input in the case of food allergy and patient education to support all patients in the supported self-management of their condition on a daily basis. A strong appreciation of these multidisciplinary aspects will help physicians provide quality patient-centered care. We consider that harmonization of allergy components within undergraduate curricula is crucial to ensure all physicians develop the appropriate allergy-related knowledge and skills, particularly in light of inconsistencies seen in the primary care management of allergy. This review from the World Allergy Organization (WAO) Education and Training Committee also outlines allergy-related competences required of physicians working with allergic patients and provides recommendations to promote harmonization of allergy training and practice worldwide.

AMEE Consensus Statement: Planetary health and education for sustainable healthcare.

The purpose of this Consensus Statement is to provide a global, collaborative, representative and inclusive vision for educating an interprofessional healthcare workforce that can deliver sustainable healthcare and promote planetary health. It is intended to inform national and global accreditation standards, planning and action at the institutional level as well as highlight the role of individuals in transforming health professions education. Many countries have agreed to 'rapid, far-reaching and unprecedented changes' to reduce greenhouse gas emissions by 45% within 10 years and achieve carbon neutrality by 2050, including in healthcare. Currently, however, health professions graduates are not prepared for their roles in achieving these changes. Thus, to reduce emissions and meet the 2030 Sustainable Development Goals (SDGs), health professions education must equip undergraduates, and those already qualified, with the knowledge, skills, values, competence and confidence they need to sustainably promote the health, human rights and well-being of current and future generations, while protecting the health of the planet.The current imperative for action on environmental issues such as climate change requires health professionals to mobilize politically as they have before, becoming strong advocates for major environmental, social and economic change. A truly ethical relationship with people and the planet that we inhabit so precariously, and to guarantee a future for the generations which follow, demands nothing less of all health professionals.This Consensus Statement outlines the changes required in health professions education, approaches to achieve these changes and a timeline for action linked to the internationally agreed SDGs. It represents the collective vision of health professionals, educators and students from various health professions, geographic locations and cultures. 'Consensus' implies broad agreement amongst all individuals engaged in discussion on a specific issue, which in this instance, is agreement by all signatories of this Statement developed under the auspices of the Association for Medical Education in Europe (AMEE).To ensure a shared understanding and to accurately convey information, we outline key terms in a glossary which accompanies this Consensus Statement (Supplementary Appendix 1). We acknowledge, however, that terms evolve and that different terms resonate variably depending on factors such as setting and audience. We define education for sustainable healthcare as the process of equipping current and future health professionals with the knowledge, values, confidence and capacity to provide environmentally sustainable services through health professions education. We define a health professional as a person who has gained a professional qualification for work in the health system, whether in healthcare delivery, public health or a management or supporting role and education as 'the system comprising structures, curricula, faculty and activities contributing to a learning process'. This Statement is relevant to the full continuum of training - from undergraduate to postgraduate and continuing professional development.

Adapting to the impact of COVID-19: Sharing stories, sharing practice.

Health Professions' Educators (HPEs) and their learners have to adapt their educational provision to rapidly changing and uncertain circumstances linked to the COVID-19 pandemic. This paper reports on an AMEE-hosted webinar: Adapting to the impact of COVID-19: Sharing stories, sharing practice. Attended by over 500 colleagues from five continents, this webinar focused on the impact of the virus across the continuum of education and training. Short formal presentations on teaching and learning, assessment, selection and postgraduate training generated wide-ranging questions via the Chatbox. A thematic analysis of the Chatbox thread indicated the most pressing concerns and challenges educators were experiencing in having to adapt programmes and learning across the continuum of medical education and training. The main areas of concern were: campus-based teaching and learning; clinical teaching; selection and assessment, and educator needs. While there is clearly no one simple solution to the unprecedented issues medical education and training face currently, there were two over-arching messages. First, this is a time for colleagues across the globe to help and support each other. Second, many local responses and innovations could have the potential to change the shape of medical education and training in the future.

Incidence of venous thromboembolism among postmenopausal women prescribed ospemifene, selective estrogen receptor modulators for noncancer indications, or untreated vulvar and vaginal atrophy.

OBJECTIVE: Ospemifene is a nonsteroidal selective estrogen receptor modulator (SERM) for the treatment of moderate symptomatic vulvar and vaginal atrophy (VVA) due to menopause. A postauthorization safety study is currently examining the incidence of venous thromboembolism (VTE) among postmenopausal women receiving ospemifene or other SERM (raloxifene, bazedoxifene, or tamoxifen, for noncancer indications), or with untreated VVA. METHODS: This interim analysis used the US MarketScan Commercial and Medicare Supplemental claims database from 2013 to 2017 to identify incident VTE. The incidence rate and 95% confidence interval of VTE during the first continuous course of treatment (or continuous untreated time for the untreated cohort) were calculated for each cohort overall and by age group, with sensitivity analyses examining incidence in the short term (up to 90 days) and long term (all available follow-up, regardless of treatment changes). RESULTS: Analyses included 8,188 ospemifene users, 11,777 other SERM users, and 220,242 women with untreated VVA. The incidence per 1,000 person-years and 95% confidence interval of VTE were 3.7 (1.7-7.1) for ospemifene, 11.5 (8.9-14.6) for other SERM, and 11.3 (10.8-11.7) for untreated VVA. Stratification by age and altering the time frame for analysis produced results with similar patterns to the primary analysis. CONCLUSIONS: This interim analysis of an ongoing study suggests a favorable safety profile for ospemifene with respect to VTE. Comparative analyses with covariate adjustment will be performed when data accrual is complete.

Health Professions' Educators' Adaptation to Rapidly Changing Circumstances: The Ottawa 2020 Conference Experience.

This article was migrated. The article was marked as recommended. Most health professions' educators (HPEs) are used to responding to change, whether these are longer term organisational changes or short term crises, e.g. staff or student sickness or technical systems' failures. Most of these changes, whilst they can be frustrating, typically have fairly straightforward and routine solutions. Other wider, environmental changes are also starting to affect educators, learners and the complex education and healthcare systems in which they operate, and these will have great impact in the relatively near future. However, it is the current crisis stemming from the global transmission of the coronavirus COVID-19 which has most recently impacted on HPE on a global scale. Whilst many of us are very used to working virtually and using social media and other activities to work collaboratively, we still tend to rely on regular meetings with friends and colleagues (old and new) around the world at conferences and meetings. Similarly, most universities rely primarily on face to face teaching to provide their programmes, particularly in the early years. The COVID-19 pandemic has put all that into sharp relief, and many of us are having to make quick and sometimes reactive adaptations to our best-laid plans. In this article, we discuss some of our experiences from the recent Ottawa 2020 conference held in Kuala Lumpur from 1-5 March 2020, identifying some of the lessons learned that educators around the world will need to keep in mind as we move into what is currently unchartered territory. The learning lessons from our experience are that safety is paramount, communication and transparency is key; flexibility is needed from all stakeholders; technologies can help, but be realistic; acknowledge the need for psychological adaptation to change and crisis and tap into the wisdom and collegiality of the community. This paper specifically refers to Covid-19 but the learning lessons are applicable to other major challenges and the ideas described transferable to other situations.

Impact of the COVID-19 pandemic: The perceptions of health professions educators.

This article was migrated. The article was marked as recommended. What are health professions educators doing during the COVID-19 pandemic? A search of articles in MedEdPublish on the topics of COVID-19 revealed 39 articles published in the first 3 months of the pandemic. Topics included curriculum adaptation, guidelines for using technology, assessment adaptation, impact on students, faculty and career development, and conference adaptation. There was significant overlap among articles, particularly those discussing teaching, learning, and assessment practices. Common themes were adaptation, innovation, remote delivery, flexibility in the face of a pandemic, and how to continue to educate and graduate competent health professionals. All articles were descriptive, and none included data describing efficacy, likely due to the short timeline since the pandemic's inception. Additional study is necessary to produce evidence for the teaching and assessment adaptations described. Some changes are likely to persist longer-term and may outlast the pandemic itself.

How to review a paper on medical education.

This article was migrated. The article was marked as recommended. There has been a substantial increase in the number of medical and health professional education manuscripts being submitted to an increasing number of journals in this field. More reviews and more reviewers are needed to facilitate discussion of both relevance and quality of those manuscripts. MedEdPublish relies on readers and Review Panel members to contribute to this process, thereby helping to maintain standards in medical and health professional education publishing. This article provides guidance that is most relevant to reviewers and potential authors for MedEdPublish, but may be relevant to publishing in other medical and health professional journals.

Sharing stories about medical education in difficult circumstances: Conceptualizing issues, strategies, and solutions.

BACKGROUND: Global economic forces, political decisions, and natural disasters are only some of the factors that affect contemporary healthcare education. Given the centrality of health in all settings, the future of healthcare education depends on how we overcome these difficult circumstances. METHODS: Through a series of collaborative activities involving healthcare educators from around the world and their attempts to overcome these difficulties, the authors have developed a conceptual model centered around the people involved, the impact of culture, and organizations and systems. RESULTS: The model can help to frame discussions and develop strategies about how best we, as a community of health professionals and educators, collaborate and share wisdom, experiences and resources to assist colleagues who might be struggling to deliver education. What has clearly emerged from this work is the centrality of leadership and management in effectively challenging and addressing difficult circumstances. CONCLUSIONS: Contemporary health professions' education leadership needs to be inclusive, mindful, compassionate and caring; echoing and role-modeling how we expect our students to be with patients and colleagues. This means being willing to confront unacceptable behaviors and speak out and challenge authority when needed. It also requires awareness and understanding of the complex systems in which healthcare education is provided.

Opening Editorial - The Importance of the Humanities in Medical Education.

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Concluding Commentary. The Importance of the Humanities in Medical Education: Where are we now?

This article was migrated. The article was marked as recommended. The undergraduate medical curriculum, together with many of the other healthcare curricula, is under a constant state of change. Sometimes that change is for the better, very occasionally less so. Many physicians who graduated more than forty years ago may agree that the humanities were a strong component of the hidden curriculum; the humanities were just there and enhanced many teaching activities (mainly lectures) to a variable state. They were used by a certain proportion of faculty to make their lectures "more exciting", "more real" and "to put them in context". Over time and as new teaching and learning technologies took the place of formal teaching (such as lectures), these humanities approaches and enhancements appeared to become less prominent. This new AMEE MedEdPublish theme - The Importance of the Humanities in Medical Education - has not only demonstrated that the humanities are not gone and lost forever, they were just hidden, but the number of papers received demonstrated that the subject is certainly healthier than expected and suggests the inclusion of the Humanities within all forms of healthcare curricula and training opportunities. This concluding commentary provides an overview of the large number of papers received, explores the various reasons that support the presence of the humanities in the curriculum, provides insight into the ways that the humanities are being taught and finally, provides some direction of the way forward.

Medical education in difficult circumstances: A global responsibility to contribute.

Medical and health professions' education is becoming increasingly standardized across the world in terms of core standards and competencies. Yet, the context in which education and training occurs is far from even. Many educators face challenges in providing health professions' education, ranging from individual challenges and organizational struggles, to working in countries experiencing major conflict or environmental disaster. This commentary sets the scene for an international discussion on might constitute "difficult circumstances" and invites educators from around the world to contribute to the discussion by sharing their stories and suggesting strategies and solutions in a themed issue of MedEdPublish, AMEE's (the Association for Medical Education in Europe) innovative online journal.

Editorial: Medical Education in Difficult Circumstances.

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