Promoting the process of determining brain death through standardized training.

Objective: This study aims to explore the training mode for brain death determination to ensure the quality of subsequent brain death determination. Methods: A four-skill and four-step (FFT) training model was adopted, which included a clinical neurological examination, an electroencephalogram (EEG) examination, a short-latency somatosensory evoked potential (SLSEP) examination, and a transcranial Doppler (TCD) examination. Each skill is divided into four steps: multimedia theory teaching, bedside demonstration, one-on-one real or dummy simulation training, and assessment. The authors analyzed the training results of 1,577 professional and technical personnel who participated in the FFT training model from 2013 to 2020 (25 sessions), including error rate analysis of the written examination, knowledge gap analysis, and influencing factors analysis. Results: The total error rates for all four written examination topics were < 5%, at 4.13% for SLSEP, 4.11% for EEG, 3.71% for TCD, and 3.65% for clinical evaluation. The knowledge gap analysis of the four-skill test papers suggested that the trainees had different knowledge gaps. Based on the univariate analysis and the multiple linear regression analysis, among the six factors, specialty categories, professional and technical titles, and hospital level were the independent influencing factors of answer errors (p < 0.01). Conclusion: The FFT model is suitable for brain death (BD) determination training in China; however, the authors should pay attention to the professional characteristics of participants, strengthen the knowledge gap training, and strive to narrow the difference in training quality.

Making co-creation operational: A RECONECT seven-steps-pathway and practical guide for co-creating nature-based solutions.

Co-creation as a practice of collaborative product or service development is not a novel concept, however its application in the field of nature-based solutions (NBS) requires a certain level of knowledge, expertise and capacity building to ensure a shared understanding and collaborative dialogue. NBS are defined as cost-effective and ecosystem-based solutions to solving sustainability challenges and climate-change pressures through embedding a more citizen-oriented engagement within its implementation. Although some co-creation principles and guidelines are scientifically well elaborated, only a few of them was put into practice. Thus there is still a need for making them clearer and more feasible to a broad range of stakeholders from the non-scientific community. This problem is mostly caused by the lack of easy-to use framework / strategy for organizing a co-creation and selecting the appropriate co-creation activity for the certain purpose of the NBS realization process. It includes making a right decision on what particular tools, how and with what groups of stakeholders can be applied in a certain case and by the availability of particular resources. For this purpose, a stepwise pathway/guide on how participatory approach can be incorporated into the whole process of NBS co-creation was developed within the RECONECT project. The main innovative contribution of this work is to propose the following ready-to-use solutions:•detailed seven-steps-co-creation pathway and practical recommendations for NBS design and implementation;•multidimensional and comprehensive decision-making matrix consisting of 88 tools for selecting the most suitable solution (tool) according to the particular co-creation goal, available resources and capacities;•additional resources to facilitate and operationalise the co-creation process at each stage of NBS development, offered in the form of a Toolbox.

CO-Creation and Evaluation of Food Environments to Advance Community Health (COACH).

Introduction: Food environments are a key determinant of food intake and diet-related health. This paper describes the development of an iterative, adaptive, context-specific framework for health-enabling food environments embedded in cocreation theory. Methods: A 3-stage multimethod framework for the coproduction and prototyping of public health interventions was followed in an iterative manner during the development of the framework. These 3 stages were (1) evidence review, including systematic review, consultation with experts, and observation of current work; (2) codesign of the framework prototype with multiple stakeholders; and (3) coproduction through refinement of the prototype through stakeholder workshops and expert reviews with incorporation of researcher notes and workshop evaluation. We use the term prototype during the development phase and the term framework to report on the final product. Results: COACH (CO-creation and evaluation of food environments to Advance Community Health) is a process framework that describes what best practice application of cocreation in health-enabling food retail environments should involve. COACH consists of 10 interdependent factors within a 4-phase continuous quality improvement cycle. The 4 phases of the cycle are engagement and governance establishment, communication and policy alignment, codesign and implementation, and monitoring and evaluation. Conclusions: Utilizing cocreation theory represents an innovative step in research and practice to improve the healthiness of food retail environments. COACH provides a specific, unique, and comprehensive guide to the utilization of cocreation to improve the healthiness of food environments in practice.

Optimal practices for the management of hereditary transthyretin amyloidosis: real-world experience from Japan, Brazil, and Portugal.

Hereditary transthyretin (ATTRv) amyloidosis is a rare and autosomal dominant disorder associated with mutations in the transthyretin gene. Patients present with diverse symptoms related to sensory, motor, and autonomic neuropathy, as well as gastrointestinal, ocular, cardiac, renal and orthopedic symptoms, resulting from the deposition of transthyretin amyloid fibrils in multiple organs. The progressive nature of ATTRv amyloidosis necessitates pre- and post-onset monitoring of the disease. This review article is primarily based on a collation of discussions from a medical advisory board meeting in August 2021. In this article, we summarize the best practices in amyloidosis centers in three major endemic countries for ATTRv amyloidosis (Japan, Brazil, and Portugal), where most patients carry the Val30Met mutation in the transthyretin gene and the patients' genetic background was proven to be the same. The discussions highlighted the similarities and differences in the management of asymptomatic gene mutation carriers among the three countries in terms of the use of noninvasive tests and tissue biopsies and timing of starting the investigations. In addition, this article discusses a set of practical tests and examinations for monitoring disease progression applicable to neurologists working in diverse medical settings and generalizable in non-endemic countries and areas. This set of assessments consists of periodic (every 6 to 12 months) evaluations of patients' nutritional status and autonomic, renal, cardiac, ophthalmologic, and neurological functions. Physical examinations and patient-reported outcome assessments should be also scheduled every 6 to 12 months. Programs for monitoring gene mutation carriers and robust referral networks can aid in appropriate patient management in pre- to post-onset stages. For pre- and post-symptom onset testing for ATTRv amyloidosis, various noninvasive techniques are available; however, their applicability differs depending on the medical setting in each country and region, and the optimal option should be selected in view of the clinical settings, medical environment, and available healthcare resources in each region.

Consensus on the management of platinum-sensitive high-grade serous epithelial ovarian cancer in Lebanon.

Ovarian cancer is the most lethal gynecologic cancer. The high grade serous epithelial (HGSE) subtype is the most aggressive and it often presents at advanced stages, while screening programs have not proven beneficial. Management of the advanced stages (FIGO III and IV), which constitute the majority of diagnoses, usually consists of platinum-based chemotherapy and cytoreductive surgery (primary or interval) followed by maintenance therapy. Currently, the standard-of-care for advanced newly diagnosed HGSE ovarian cancer, as per international medical societies, starts with upfront cytoreductive surgery, followed by platinum-based chemotherapy (mostly carboplatin and paclitaxel) and/or anti-angiogenic agent bevacizumab, then maintenance therapy with a poly(ADP-ribose) polymerase (PARP) inhibitor with/without/or bevacizumab (continued). PARP inhibitor use depends on the patient's genetic signature, mainly the breast cancer gene (BRCA) mutation and the homologous recombination deficiency (HRD) status. Therefore, genetic testing is recommended at diagnosis to inform treatment and prognosis. In line with the evolving standard-of-care for ovarian cancer, a panel of experts in treating advanced ovarian cancer convened to lay down practical recommendations on the management of advanced ovarian cancer in Lebanon; since the currently applicable guidelines by the Lebanese Ministry of Public Health for cancer treatment have not been updated yet to reflect the treatment paradigm shift brought upon by the development and approval of PARP inhibitors. The current work reviews the leading clinical trials on PARP inhibitors (as maintenance for newly diagnosed advanced and platinum-sensitive relapsed ovarian cancer), presents international recommendations, and proposes treatment algorithms for optimal local practice.

Diagnosis and management of patients with stage III non­small cell lung cancer: A joint statement by the Lebanese Society of Medical Oncology and the Lebanese Pulmonary Society (Review).

Proper management of stage III non-small cell lung cancer (NSCLC) might result in a cure or patient long-term survival. Management should therefore be preceded by adequate and accurate diagnosis and staging, which will inform therapeutic decisions. A panel of oncologists, surgeons and pulmonologists in Lebanon convened to establish a set of recommendations to guide and unify clinical practice, in alignment with international standards of care. Whilst chest computerized tomography (CT) scanning remains a cornerstone in the discovery of a lung lesion, a positron-emission tomography (PET)/CT scan and a tumor biopsy allows for staging of the cancer and defining the resectability of the tumor(s). A multidisciplinary discussion meeting is currently widely advised for evaluating patients on a case-by-case basis, and should include at least the treating oncologist, a thoracic surgeon, a radiation oncologist and a pulmonologist, in addition to physicians from other specialties as needed. The standard of care for unresectable stage III NSCLC is concurrent chemotherapy and radiation therapy, followed by consolidation therapy with durvalumab, which should be initiated within 42 days of the last radiation dose; for resectable tumors, neoadjuvant therapy followed by surgical resection is recommended. This joint statement is based on the expertise of the physician panel, available literature and evidence governing the treatment, management and follow-up of patients with stage III NSCLC.

Medical nutrition therapy in patients receiving ECMO: Evidence-based guidance for clinical practice.

Patients receiving extracorporeal membrane oxygenation (ECMO) inherit substantial disease-associated metabolic, endocrinologic, and immunologic modifications. Along with the technical components of ECMO, the aforementioned alterations may affect patients' needs and feasibility of adequate macronutrient and micronutrient supply and intake. Thus, patients receiving ECMO are at increased risk for iatrogenic malnutrition and require targeted individual medical nutrition therapy (MNT). However, specific recommendations for MNT in patients receiving ECMO are limited and, with some exceptions, based on an evidence base encompassing general patients who are critically ill. Consequently, clinician decision-making for MNT in patients receiving ECMO is unguided, which may further increase nutrition risk, culminating in iatrogenic malnutrition and ultimately affecting patient outcomes. The purpose of this article is to provide educational background and highlight specific points for MNT in adult patients receiving ECMO, which might serve as evidence-based guidance to develop institutional standard operating procedures and nutrition protocols for daily clinical practice.

A clinician's guide for administration of high-concentration and facilitated subcutaneous immunoglobulin replacement therapy in patients with primary immunodeficiency diseases.

Immunoglobulin replacement therapy is the standard-of-care treatment for patients with primary immunodeficiency diseases who have impaired antibody production and function. Clinicians and patients may consider intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) options, and each route may offer different benefits for the individual. IVIG requires fewer infusion sites and less frequent infusions than some formulations of SCIG. However, SCIG does not require venous access, is associated with fewer systemic adverse infusion reactions than IVIG, and can independently be self-administered at home. Importantly, tailoring treatment experiences to the needs of the individual may improve treatment adherence and quality of life for patients with primary immunodeficiency diseases who often rely on long-term or lifelong treatment. This review aims to educate United States (US) healthcare providers on the administration process of SCIG, with a focus on more concentrated formulations of SCIG and facilitated SCIG. It provides practical guidance on initiating, optimizing, and monitoring SCIG therapy. The advantages and disadvantages of the different treatment options are also presented for discussion between the patient and clinician.

Menstrual management among adolescent girls in Uttar Pradesh, India: An examination of interpersonal and mediated communication as delivery mechanisms for practical guidance.

Background: Adolescent girls' right to achieve menstrual health and hygiene management (MHHM) healthfully is yet to be realized. One reason is the lack of practical guidance on the procurement, use, and disposal of menstrual products. This study defined interpersonal practical guidance (IPG) as face-to-face communication and mediated practical guidance (MPG) as social and behavior change communication (SBCC) intervention-driven communications through print and media materials. We examine the impact of these two delivery mechanisms of practical guidance on adolescent MHHM knowledge, attitudes, and practices (KAP) following an SBCC intervention in India. Objectives: To understand how IPG and SBCC-driven MPG independently influence adolescent girls' KAP on the procurement, use, and disposal of menstrual products and whether those who receive both IPG and MPG have better KAP related to the procurement, use, and disposal of menstrual cloth or sanitary pads than those who receive only one form of practical guidance or none at all. Methods: Adolescent girls' questionnaire responses from GARIMA's case-comparison evaluation were analyzed using Stata/SE 17 (n = 2,384). Girls were matched on sociodemographic and socioeconomic variables. χ 2 analysis examined relationships between sociodemographic, practical guidance, and KAP variables. Multivariate logistic regression assessed associations between practical guidance and KAP variables. Results: There are significant associations between adolescent girls' KAP depending on whether they received IPG, SBCC-driven MPG, or both. IPG and MPG delivered together has greater odds of predicting correct menstrual management KAP than when delivered separately. These effects were most notable for adolescent girls' knowledge and practices related to using and disposing of menstrual hygiene products. Conclusion: There is urgent need to create positive, sustainable changes to address menstrual health and hygiene management. This study introduces an innovative approach that utilizes interpersonal and mediated communication as mechanisms to deliver practical guidance on menstrual management. Future interventions should implement and evaluate to better understand the role of practical guidance in ensuring all women and girls are prepared to confidently manage their menstrual health.

Egyptian practical guidance in hypertriglyceridemia management 2021.

Hypertriglyceridemia (HTG) is a very common, yet underappreciated problem in clinical practice. Elevated triglyceride (TG) levels are independently associated with atherosclerotic cardiovascular disease (ASCVD) risk. Furthermore, severe HTG may lead to acute pancreatitis. Although LDL-guided statin therapy has improved ASCVD outcomes, residual risk remains. Recent trials have demonstrated that management of high TG levels, in patients already on statin therapy, reduces the rate of major vascular events. Few guidelines were issued, providing important recommendations for HTG management strategies. The goal of treatment is to reduce the risk of ASCVD and acute pancreatitis. The management stands on lifestyle modification, detection of secondary causes of HTG and pharmacological therapy, when indicated. In this guidance we review the causes and classification of HTG and summarize the current methods for risk estimation, diagnosis and treatment. The present guidance provides a focused update on the management of HTG, outlined in a simple user-friendly format, with an emphasis on the latest available data.

Co-creation of practical "how-to guides" for patient engagement in key phases of medicines development-from theory to implementation.

BACKGROUND: The effective impact of patient engagement (PE) across the medicines development continuum is widely acknowledged across diverse health stakeholder groups, including health authorities; however, the practical applications of how to implement meaningful and consistent PE are not always addressed. Guidance for the practical implementation of PE requires granularity, and the need for such guidance has been identified as a priority. We describe the co-production and summarize the content of how-to guides that focus on PE in the early stages of medicines development. METHODS: Multi-stakeholder working groups (WGs) were established by Patient Focused Medicines Development (PFMD) for how-to guide development. How-to guides were co-produced with patients for PE activities identified as priorities through public consultation and by WGs. Guides were developed by applying PE quality guidance and associated quality criteria in an iterative process. How-to guides underwent internal review and validation by experts (ie, those with relevant experience in the particular PE activity or focus area) in specific focus groups and external review and validation through appropriate events and public consultation. RESULTS: Overall, 103 individual contributors from 38 organizations (representing eight stakeholder groups, including patients/patient organizations) and from 14 countries were organized into WGs and workstreams. Each WG comprised 15-30 contributors with PE experience relevant to the specific how-to guide. How-to guides were developed for PE in the early discovery and preclinical phases; PE in the development of a clinical outcomes assessment strategy; and PE in clinical trial protocol design. The how-to guides have a standardized format and structure to promote user familiarity. They provide detailed guidance and examples that are relevant to the individual PE activity and aim to facilitate the practical implementation of PE. CONCLUSIONS: The how-to guides form a comprehensive series of actionable and stepwise resources that build from and integrate the PE quality criteria across the medicines continuum. They will be made freely available through PFMD's Patient Engagement Management Suite ( pemsuite.org ) and shared widely to a variety of audiences in different settings, ensuring access to diverse patient populations. Implementation of these guides should advance the field of PE in bringing new medicines to the market and ultimately will benefit patients. Medicines are developed to help patients improve their health and lives. Many organizations and individuals want to ensure that medicines are developed to meet real patient needs and to address what is most important to patients. Finding out what patients need and what patients want requires good patient engagement, but knowing how to do patient engagement is not always clear. This is because medicines development is complicated, and a lot of different steps, people, and organizations are involved. Patient Focused Medicines Development (PFMD) was established in 2015 to connect individuals and organizations that are committed to making medicines not just for patients but with patients. To do this, PFMD brought together patients and other groups of people with relevant experience and good ideas on how to achieve patient engagement in the real-world setting. Together, PFMD has developed "how-to guides" for patient engagement that cover the main activities along the medicines development process. The guides are free to use and provide practical advice and examples that anyone can use in their patient engagement activities. The how-to guides will also help patients to understand medicines development and how best they can participate in this process to address their needs.

Diagnosis and Management of Heart Failure in Elderly Patients from Hospital Admission to Discharge: Position Paper.

Multidisciplinary management of worsening heart failure (HF) in the elderly improves survival. To ensure patients have access to adequate care, the current HF and French health authority guidelines advise establishing a clearly defined HF patient pathway. This pathway involves coordinating multiple disciplines to manage decompensating HF. Yet, recent registry data indicate that insufficient numbers of patients receive specialised cardiology care, which increases the risk of rehospitalisation and mortality. The patient pathway in France involves three key stages: presentation with decompensated HF, stabilisation within a hospital setting and transitional care back out into the community. In each of these three phases, HF diagnosis, severity and precipitating factors need to be promptly identified and managed. This is particularly pertinent in older, frail patients who may present with atypical symptoms or coexisting comorbidities and for whom geriatric evaluation may be needed or specific geriatric syndrome management implemented. In the transition phase, multi-professional post-discharge management must be coordinated with community health care professionals. When the patient is discharged, HF medication must be optimised, and patients educated about self-care and monitoring symptoms. This review provides practical guidance to clinicians managing worsening HF in the elderly.

Updated International Tuberous Sclerosis Complex Diagnostic Criteria and Surveillance and Management Recommendations.

BACKGROUND: Tuberous sclerosis complex (TSC) is an autosomal dominant genetic disease affecting multiple body systems with wide variability in presentation. In 2013, Pediatric Neurology published articles outlining updated diagnostic criteria and recommendations for surveillance and management of disease manifestations. Advances in knowledge and approvals of new therapies necessitated a revision of those criteria and recommendations. METHODS: Chairs and working group cochairs from the 2012 International TSC Consensus Group were invited to meet face-to-face over two days at the 2018 World TSC Conference on July 25 and 26 in Dallas, TX, USA. Before the meeting, working group cochairs worked with group members via e-mail and telephone to (1) review TSC literature since the 2013 publication, (2) confirm or amend prior recommendations, and (3) provide new recommendations as required. RESULTS: Only two changes were made to clinical diagnostic criteria reported in 2013: "multiple cortical tubers and/or radial migration lines" replaced the more general term "cortical dysplasias," and sclerotic bone lesions were reinstated as a minor criterion. Genetic diagnostic criteria were reaffirmed, including highlighting recent findings that some individuals with TSC are genetically mosaic for variants in TSC1 or TSC2. Changes to surveillance and management criteria largely reflected increased emphasis on early screening for electroencephalographic abnormalities, enhanced surveillance and management of TSC-associated neuropsychiatric disorders, and new medication approvals. CONCLUSIONS: Updated TSC diagnostic criteria and surveillance and management recommendations presented here should provide an improved framework for optimal care of those living with TSC and their families.

Egyptian practical guidance in lipid management 2020.

BACKGROUND: Numerous epidemiological investigations and randomized clinical studies have determined that dyslipidemia is a major contributor to atherosclerotic cardiovascular disease (ASCVD). Consequently, the management of serum cholesterol and low-density lipoprotein levels has become a central objective in the effort to prevent cardiovascular events. MAIN BODY: Many guidelines were issued by different organizations and societies to define patient risk and establish important recommendations for management strategies. Newer cholesterol-lowering agents (non-statin drugs) are described, and their use is directed primarily to secondary prevention in patients at very high risk of new ASCVD. CONCLUSION: The present guidance summarizes the current methods for risk estimation and outlines the most recent data on lipid management in a simple user-friendly format, to improve physician awareness and help implement guidelines in the daily practice.

Palbociclib and beyond for the treatment of HR + HER2- metastatic breast cancer: an Asian-Pacific perspective and practical management guide on the use of CDK4/6 inhibitors.

Breast cancer is the most frequent cancer amongst women worldwide including in Asia where the incidence rate is rapidly increasing. Even with treatment, around 30% of patients with early breast cancer progress to metastatic disease, with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer the most common phenotype. First-line endocrine therapy targeting the estrogen receptor signaling pathway provides a median progression-free survival or time to progression of 6-15 months in HR + HER2- metastatic breast cancer. Recently, cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors, combined with endocrine therapy, have achieved more than two years median progression-free survival in HR + HER2- metastatic breast cancer. However, the characteristics of the Asian breast cancer population differ from those of Western populations and need to be considered when selecting a suitable treatment. Breast cancer is diagnosed at a younger age in Asian populations and late stage at presentation is generally more common in low-/middle-income countries than high-income countries. Consequently, the proportion of premenopausal women with metastatic breast cancer is higher in Asian compared with Western populations. While CDK4/6 inhibitors have been approved in the USA (FDA) since 2015, experience with them in Asia is more limited. We review the experience with the CDK4/6 inhibitor palbociclib in Asian patients with HR + HER2- metastatic breast cancer and provide guidance on the use of palbociclib in these patients.

Sacubitril/valsartan: A practical guide.

Renin-angiotensin-aldosterone system (RAAS) inhibitors are a cornerstone in the treatment of heart failure with reduced ejection fraction (HFrEF). Sacubitril/valsartan modulates the neurohormonal axis by inhibiting both angiotensin receptors and neprilysin, and improves neurohormonal balance more than blocking the RAAS alone. The PARADIGM-HF trial validated this new treatment option for patients with HFrEF. Sacubitril/valsartan was also more effective than enalapril in slowing disease progression by decreasing the risk of worsening heart failure requiring hospitalization or emergency admission and the need for intensified therapy, heart failure devices or cardiac transplantation. More than 70% of patients included in PARADIGM-HF were in NYHA class II, and overall, the results indicate that sacubitril/valsartan should be started in the earliest symptomatic stages of the disease. As PARADIGM-HF has excellent robustness for a cardiovascular trial, sacubitril/valsartan has been included as a new treatment option with a strong level of recommendation in the main international guidelines. This expert task force proposes a practical guide to the use of this new drug that has been endorsed by the Working Group on Heart Failure of the Portuguese Society of Cardiology.

Iron deficiency in chronic heart failure: case-based practical guidance.

In patients with chronic heart failure, iron deficiency, even in the absence of anaemia, can aggravate the underlying disease and have a negative impact on clinical outcomes and quality of life. The 2016 European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure recognize iron deficiency as a co-morbidity in chronic heart failure and recommend iron status screening in all newly diagnosed patients with chronic heart failure. Furthermore, the guidelines specifically recommend considerations of intravenous iron therapy, ferric carboxymaltose, for the treatment of iron deficiency. However, in spite of these recommendations, iron deficiency remains often overlooked and undertreated. This may be due, in part, to the lack of clinical context and practical guidance accompanying the guidelines for the treating physician. Here, we provide practical guidance complemented by a case study to assist and improve the timely diagnosis, treatment, and routine management of iron deficiency in patients with chronic heart failure.

Exploring the Gaps in Practical Ethical Guidance for Animal Welfare Considerations of Field Interventions and Innovations Targeting Dogs and Cats.

Domestic dogs (Canis lupus familiaris) and cats (Felis silvestris catus) are common species targeted by nongovernmental or intergovernmental organizations, veterinarians and government agencies worldwide, for field interventions (e.g., population management, rabies vaccination programs) or innovations (e.g., development of technologies or pharmaceuticals to improve animal welfare). We have a moral responsibility to ensure that the conduct of this work is humane for dogs or cats, and to consider the human communities in which the animals live. Ethical review is widely accepted as being integral to responsible practice, and it is fundamental to good science that underpins innovation. Despite the necessity of field interventions or innovations to advance the welfare of individuals or populations of animals, we found a lack of specific guidance and review processes to help navigate ethical dilemmas surrounding the conduct of such work. This can be detrimental to the wellbeing of animals and their human communities. Here we identify the gaps in existing ethical frameworks (specifically application of Reduction and Refinement principles, challenges of obtaining meaningful informed consent with variations in the quality of human-animal relationships, and limited resources regarding considerations of local stakeholders), and outline the need for additional tools to promote ethical conduct in the field.

Practical guidance on the use of laboratory testing in the management of bleeding in patients receiving direct oral anticoagulants.

Direct oral anticoagulants (DOACs) have demonstrated a favorable benefit-risk profile in several thromboembolic disorders and are increasingly used in routine clinical practice. A number of real-world studies on DOACs are ongoing, and data published so far have shown broadly similar outcomes to those demonstrated in the respective phase III trials. Despite their beneficial attributes, bleeding risk (as with any other anticoagulants) is often a concern for physicians when prescribing DOACs, particularly in elderly patients, those with significant comorbidities, and other high-risk patient populations. Although the absence of routine coagulation monitoring is an advantage of the DOACs, measuring their anticoagulant effect and/or plasma drug levels may be helpful in certain clinical scenarios to help patient management and improve outcomes. In this paper, practical guidance and recommendations are provided for clinical situations in which the test results may aid clinical decision-making, including patients with life-threatening bleeding events, patients without bleeding but with test results indicating a risk of bleeding, for those patients with a suspected thromboembolism while receiving a DOAC, or prior to patients undergoing elective or urgent surgical procedures. Finally, appropriate monitoring of the DOACs could be of substantial benefit to patients, and there is a high potential for development in this area in the future.

Practical guidance on the use of olaparib capsules as maintenance therapy for women with BRCA mutations and platinum-sensitive recurrent ovarian cancer.

Olaparib is the first oral poly(ADP-ribose) polymerase inhibitor to be approved as maintenance monotherapy for treatment of patients with platinum-sensitive relapsed BRCA-mutated (BRCAm) serous ovarian cancer. This review provides practical guidance on the use of olaparib (capsule formulation) in the maintenance setting. The article focuses on the key toxicities that can arise with olaparib therapy and recommendations for their management. Nausea, vomiting, fatigue and anemia are the most commonly reported adverse events in olaparib clinical trials and are generally mild to moderate and transient in nature in most patients. Implementation of an effective and timely management plan can control many of the side effects. It is vital that health care providers effectively communicate the potential side effects of olaparib, as well as educate patients on management strategies to combat these symptoms. To this end, realistic expectations regarding the potential side effects need to be set, with an understanding that dose interruptions and modifications may be required to allow patients to continue receiving treatment.