Expert Advisory Board Research Articles

Black Women's Perspectives on Structural Racism across the Reproductive Lifespan: A Conceptual Framework for Measurement Development.

Exposures to structural racism has been identified as one of the leading risk factors for adverse maternal and infant health outcomes among Black women; yet current measures of structural racism do not fully account for inequities seen in adverse maternal and infant health outcomes between Black and white women and infants. In response, the purpose of this study was to conceptualize structural racism from the perspectives of Black women across the reproductive lifespan and its potential impact on adverse maternal and infant health outcomes. We conducted a series of focus groups with 32 Black women across the reproductive lifespan (5 preconception, 13 pregnant, and 14 postpartum). Study criteria including self-identifying as Black, residing in Oakland or Fresno, California and representing one of three reproductive life tracks (preconception, pregnant, postpartum). We consulted with study participants and an expert advisory board to validate emergent domains of structural racism. Nine domains of structural racism emerged from a ground theory constant comparative analysis: Negative Societal Views; Housing; Medical Care; Law Enforcement; Hidden Resources; Employment; Education, Community Infrastructure; and Policing Black Families. Findings from this study suggest that there is an interplay among structural racism, and social and structural determinants of health which has negative impacts on Black women's sexual and reproductive health. Furthermore, findings from this study can be used to develop more comprehensive medical assessments and policies to address structural racism experienced by Black women across the reproductive lifespan.

Healthcare for patients with inflammatory bowel disease in Russian Federation in 2015—2021: information from the Healthcare Expert Advisory Board of the Social Policy Committee of the Federation Council

Healthcare for patients with inflammatory bowel disease in Russian Federation in 2015—2021: information from the Healthcare Expert Advisory Board of the Social Policy Committee of the Federation Council

Cost of chronic red blood cell transfusion in the Brazilian private healthcare sector from a payer perspective

Objective: In the private healthcare sector in Brazil, the dearth of information regarding transfusion cost may compromise the management of conditions requiring long-term transfusion. Therefore, the present study aimed to estimate the cost of chronic red blood cell (RBC) transfusion in this context. Methods: A payer perspective was chosen for the analysis. A survey performed by an expert advisory board gathered information on the amounts reimbursed by health plans to blood centers per outpatient transfusion of a single RBC bag in multitransfused patients. Survey results were contrasted to RBC transfusion cost calculated using Brazilian Hierarchical Classification of Medical Procedures (CBHPM) parameters from 2018 and 2010, the latter suggested by the advisory board as more accurately reflecting market prices. Results: Six blood centers in the South and Southeast of Brazil were surveyed. The median amount reimbursed per RBC unit was R$ 1,066.44 (interquartile range: R$ 665.00-1,252.00). The mean amount reimbursed was R$ 959.54 ± R$ 337.14 (minimum: R$ 295.00 – maximum: R$ 1,980.00). Using 2018 CBHPM parameters, the cost of transfusing one RBC unit was calculated as R$ 1,905.18. Using 2010 CBHPM parameters, the cost was R$ 1,119.69 per RBC unit. Conclusions: Analyses using 2018 CBHPM parameters may lead to overestimation of transfusion cost. The best estimate for outpatient transfusion of one RBC bag in the private health care sector in Brazil lies between the observed reimbursed values and 2010 CBHPM cost. The present results provide valuable information for future cost-effectiveness analyses focusing on disorders whose treatment involves routine RBC transfusion.

Cognitive and Emotional Factors and Pain-Related Outcomes in Youth with Sickle Cell Disease

Children with sickle cell disease (SCD) experience acute episodes of pain that may require visits to emergency department (ED) or hospitalizations. SCD is associated with cognitive deficits that are particularly evident in domains of executive functioning (e.g., attention, working memory). Many patients/parents also report emotional concerns related to SCD. It is not known the degree to which these concerns impact disease self-management and healthcare utilization. This study investigated cognitive and emotional factors as contributors to pain-related healthcare utilization (visits to ED and hospitalizations) in children with SCD. The cohort included 112 youth with SCD (all genotypes) between ages 7-16 years who received care at Children's National Hospital in Washington, DC. Measures of socioeconomic status (e.g., parent education, family income, 1- vs. 2-parent households), cognitive abilities, and emotional functioning were extracted from an existing database of participants who had previously enrolled in the IRB approved study of computerized working memory training. Cognitive measures included the Wechsler Intelligence Scale for Children (WISC-V) Full Scale IQ and attention, working memory, and executive functioning tests from Cogstate, a computerized cognitive assessment. Emotional functioning was measured using the Worry 1 (i.e., anxiety about SCD) and Emotions (i.e., frustration and anger about SCD) domains of both the child- and parent-rated Pediatric Quality of Life Inventory Sickle Cell Disease Module. Healthcare utilization was measured through chart review, separated into ED visits for pain and hospitalizations for pain 1 year and 3 years after enrollment. The mean age of participants was 10.61 (SD=2.91) year with majority being females (n=65; 58%). Eighty-three (74%) had sickle cell anemia (HbSS or HbSβ0 thalassemia). The median number of ED visits for pain was 1 visit (IQR=2) across 1 year after enrollment and 3 visits (IQR=6) across 3 years after enrollment. The median number of hospital admissions for pain was 0 admissions (IQR=1) across 1 year after enrollment and 1 admission (IQR=4) across 3 years after enrollment (pain hospitalizations = 1; IQR=4). Linear regression models were applied to explore whether cognitive and emotional variables were predictive of healthcare utilization for pain. Variables included in the final model were selected by using the Akaike information criterion. Results indicated that attentional abilities were significantly associated with ED visits and hospitalizations for pain, both at 1 year and 3 years after enrollment (p's<.009), such that better performance on the Cogstate attention task was associated with fewer ED visits and hospitalizations. Child-rated emotional quality of life significantly predicted ED visits for pain over 1 year (b=-0.004, p=.049) and hospitalizations for pain over 3 years (b=-0.006, p=.013), such that higher emotional quality of life was predictive of fewer ED visits and hospitalizations. Parent-rated child emotional quality of life was also predictive of hospitalizations for pain over 3 years (b=-0.007, p=.020). Neither SCD genotype nor socioeconomic status significantly impacted healthcare utilization. Results demonstrate that children's cognitive and emotional functioning play an important role in pain management and should be an integral part of comprehensive pain management plans for children with SCD. Attentional abilities emerged as a reliable predictor of pain-related healthcare utilization and may signal that poor attention makes it difficult to implement strategies to distract from pain. It could also suggest that children with poor attention have greater difficulty with behavioral aspects of disease self-management (e.g., medication adherence, avoiding pain triggers). These are important considerations, given that youth with SCD are at risk for disease-related neurological sequelae including reduced attentional abilities. Emotional functioning (specifically, frustration and anger about SCD) also predicted healthcare utilization for pain, highlighting the potential impact of stress on pain onset and management. Clinicians and researchers should consider cognitive and emotional factors when evaluating risk for pain in SCD and incorporate these factors when developing strategies to reduce healthcare utilization and costs. Disclosures Darbari: Hilton Publishing: Consultancy, Other: Expert advisory board for developing gaming app for SCD; Global blood therapeutics: Consultancy, Honoraria, Other: participated in advisory board meeting ; Novartis: Consultancy, Honoraria, Other: steering committee for SPARTAN study .

Advancing Social Mission in Nursing Education: Recommendations From an Expert Advisory Board

Social mission refers to a set of concepts and perspectives that promote health equity in health care delivery and within health professions. Little is known about social mission within the context of nursing education. This article clarifies the role of social mission in nursing education, offers current applications, and identifies future opportunities to maximize social mission within nursing to foster a more just culture of health. A multidisciplinary advisory board of experts in nursing education convened to review pertinent literature, current case exemplars, and craft a conceptual framework of social mission in nursing education. The resulting framework consisted of three action-oriented domains to implement social mission into nursing education: board accreditation, curriculum building and faculty training, and developing institutional culture. Successful implementation of social mission into nursing education, and subsequently the nursing workforce, offers the opportunity to further embed equity into health care. [J Nurs Educ. 2020;59(8):433-438.].

Highlights of an Expert Advisory Board on Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD) in Latin America.

BackgroundChronic obstructive pulmonary disease (COPD) is a preventable and usually progressive lung disease that affects millions of people worldwide and is the sixth leading cause of death in the Americas. Viral and bacterial respiratory tract infections and air pollution may cause acute exacerbations of COPD (AE-COPD) ranging from mild, moderate to severe. The greatest proportion of the overall COPD burden on the health system is due to disease exacerbations. There is limited evidence regarding the etiology and burden of AE-COPD in Latin America (LATAM).MethodsTo respond to this gap in evidence, an Advisory Board with regional pneumologists and infectious disease experts was convened in September 2018 in Panama City, Panama, to: 1) review the burden of AE-COPD in LATAM; 2) evaluate the etiology of AE-COPD in LATAM; and 3) assess and compare the local/regional guidelines to confirm the etiology, characterize, and manage AE-COPD.ResultsThe results of the meeting showed that there is a high prevalence of AE-COPD in LATAM countries, limited evidence on etiology data, and discrepancies in the case definitions and symptomology (ie, severity) classifications used in LATAM.ConclusionThe Advisory Board discussions further resulted in recommendations for future research on the impact on the epidemiology and burden of disease, on establishing standardized AE-COPD case definition guidelines, and on studying the etiology of both moderate and severe AE-COPD cases.

Complex clinical scenarios with the use of direct oral anticoagulants in patients with atrial fibrillation: amultidisciplinary expert advisory board.

The risk of developing atrial fibrillation (AF) and the risk of stroke both increase with advancing age. As such, many individuals have, or will develop, an indication for oral anticoagulation to reduce the risk of stroke. Currently, a large number of anticoagulants are available, including vitamin K antagonists, direct thrombin or factor Xa inhibitors (the last two also referred to as direct oral anticoagulants or DOACs), and different dosages are available. Of the DOACs, rivaroxaban can be obtained in the most different doses: 2.5 mg, 5 mg, 15 mg and 20 mg. Many patients develop co-morbidities and/or undergo procedures that may require the temporary combination of anticoagulation with antiplatelet therapy. In daily practice, clinicians encounter complex scenarios that are not always described in the treatment guidelines, and clear recommendations are lacking. Here, we report the outcomes of a multidisciplinary advisory board meeting, held in Utrecht (The Netherlands) on 3 June 2019, on decision making in complex clinical situations regarding the use of DOACs. The advisory board consisted of Dutch cardiovascular specialists: (interventional) cardiologist, internist, neurologist, vascular surgeon and general practitioners invited according to personal title and specific field of expertise.

Clinical efficacy assessment in severe vernal keratoconjunctivitis: preliminary validation of a new penalties-adjusted corneal fluorescein staining score

ABSTRACT Introduction and objective: Vernal keratoconjunctivitis (VKC) is a rare allergic eye condition that occurs in children and is characterised by a combination of debilitating symptoms. Repeated use of topical corticosteroid rescue therapy is often necessary in severe forms. This study aims to assess the validity of a new composite endpoint: the penalties-adjusted corneal staining score (PACS-S) proposed as primary endpoint in VEKTIS trial evaluating the efficacy of a new corticosteroid-sparing treatment, VERKAZIA® (ciclosporin 1 mg/ml eye drops), in severe VKC patients. Methodology: This research comprised a systematic literature review to identify efficacy endpoints being proposed in clinical trials for pediatric patients with severe VKC, followed by a remote expert advisory board assessing the validity of the PACS-S. Results: While no agreed or validated endpoint for assessing efficacy in VKC was identified when VEKTIS trial started, the experts’ board acknowledged a high face validity of PACS-S as a subjective integrated measure matching the current clinical practice. A fair external validity was considered with regards to VEKTIS trial secondary endpoints. Conclusion: PACS-S appears to be a reliable, valid and clinically meaningful primary endpoint that allows significant improvement over existing endpoints in severe VKC trials. Additional research is needed to validate this endpoint.

Preferred Reporting Items for Overviews of Reviews (PRIOR): a protocol for development of a reporting guideline for overviews of reviews of healthcare interventions

BackgroundOverviews of reviews (i.e., overviews) compile information from multiple systematic reviews to provide a single synthesis of relevant evidence for healthcare decision-making. Despite their increasing popularity, there are currently no systematically developed reporting guidelines for overviews. This is problematic because the reporting of published overviews varies considerably and is often substandard. Our objective is to use explicit, systematic, and transparent methods to develop an evidence-based and agreement-based reporting guideline for overviews of reviews of healthcare interventions (PRIOR, Preferred Reporting Items for Overviews of Reviews).MethodsWe will develop the PRIOR reporting guideline in four stages, using established methods for developing reporting guidelines in health research. First, we will establish an international and multidisciplinary expert advisory board that will oversee the conduct of the project and provide methodological support. Second, we will use the results of comprehensive literature reviews to develop a list of prospective checklist items for the reporting guideline. Third, we will use a modified Delphi exercise to achieve a high level of expert agreement on the list of items to be included in the PRIOR reporting guideline. We will identify and recruit a group of up to 100 international experts who will provide input into the guideline in three Delphi rounds: the first two rounds will occur via online survey, and the third round will occur during a smaller (8 to 10 participants) in-person meeting that will use a nominal group technique. Fourth, we will produce and publish the PRIOR reporting guideline.DiscussionA systematically developed reporting guideline for overviews could help to improve the accuracy, completeness, and transparency of overviews. This, in turn, could help maximize the value and impact of overviews by allowing more efficient interpretation and use of their research findings.

LBA4_PR - Nivolumab (NIVO) + low-dose ipilimumab (IPI) vs platinum-doublet chemotherapy (chemo) as first-line (1L) treatment (tx) for advanced non-small cell lung cancer (NSCLC): CheckMate 227 part 1 final analysis

LBA4_PR - Nivolumab (NIVO) + low-dose ipilimumab (IPI) vs platinum-doublet chemotherapy (chemo) as first-line (1L) treatment (tx) for advanced non-small cell lung cancer (NSCLC): CheckMate 227 part 1 final analysis

Secondary research uses of residual newborn screening dried bloodspots: a scoping review

PurposeResidual newborn screening dried bloodspots (DBS) are a valuable resource for research but the extent, type, and nature of uses are unknown. The objective of this research was to systematically review the published literature about secondary research uses of residual DBS using a scoping review protocol. MethodsA total of 654 publications meeting the inclusion criteria with a 94% interrater reliability were identified. A coding template was created with input from expert advisory board to summarize the data. Electronic literature search of Ovid MEDLINE, Embase (via Embase.com), CINAHL (EBSCO),and Science and Social Sciences Citation Indices (via Web of Science) was conducted. ResultsA large proportion of the secondary research with DBS was conducted within the United States (30%). The number of published studies utilizing DBS are increasing each year, primarily with observational or case–control designs. Only a small number of studies reported whether or not consent was obtained and if the DBS were identifiable or not. ConclusionOutcomes of this research indicate that residual DBS are well utilized worldwide for research addressing individual and public health issues. Future analyses will summarize outcomes of disease-specific research and provide evidence of the use of residual DBS in research on health outcomes.

Contextual determinants of CHILDREN\u2019S health care and policy in Europe

BackgroundThe main objective of this study was to explore the contextual determinants of child health policies.MethodsThe Horizon 2020 Models of Child Health Appraised (MOCHA) project has one Country Agent (CA) in all 30 EU and EEA countries. A questionnaire designed by MOCHA researchers as a semi-structured survey instrument asked CAs to identify and report the predominating public and professional discussions related to child health services within the last 5 years in their country and the various factors which may have influenced these. The survey was issued to CAs following validation by an independent Expert Advisory Board. The data were collected between July and December 2016.The data was qualitatively analysed using software Nvivo11 for data coding and categorization and constructing the scheme for identified processes or elements.ResultsContextual determinants of children’s health care and policy were grouped into four categories. 1) Socio-cultural determinants: societal activation, awareness, communication, trust, freedom, contextual change, lifestyle, tolerance and religion, and history. 2) Structural determinants which were divided into: a) external determinants related to elements indirectly correlated with health care and b) internal determinants comprising interdependent health care and policy processes. 3) International determinants such as cross-nationality of child health policy issues. 4) The specific situational determinants: events which contributed to intensification of debates which were reflected by behavioural, procedural, institutional and global factors.ConclusionsThe influence of context across European countries, in the process of children’s health policy development is clearly evident from our research. A number of key categories of determinants which influence child health policy have been identified and can be used to describe this context. Child health policy is often initiated in reaction to public discontentment. The multiple voices of society resulted, amongst others, in the introduction of new procedures, action plans and guidelines; raising levels of awareness, intensifying public scrutiny, increasing access and availability of services and provoking introduction of structural changes or withdrawing unfavourable changes.

Optimizing Clinical and Cost Outcomes for Patients on Enteral Nutrition Support for Treatment of Exocrine Pancreatic Insufficiency: Proceedings from an Expert Advisory Board Meeting.

Overview of exocrine pancreatic insufficiency (EPI) and related issues The pancreas, an essential part of the gastrointestinal (GI) system, is functionally composed of exocrine and endocrine constituents. Because there is minimal anatomic separation of the exocrine and endocrine pancreatic function, disease states that cause disruption or damage in one component of the organ may lead to defects in the other component.8 EPI is a relatively uncommon but severe condition that is associated with a variety of complex disorders such as cystic fibrosis (CF), pancreatic cancer, gastric/pancreatic surgery, short bowel syndrome, and chronic pancreatitis. Physiological and biochemical effects of EPI include decreased production and secretion of lipase, increased lipase destruction and degradation, and GI motility disorders. The deficiency in pancreatic enzymes (lipase, amylase, protease) results in impaired digestion and subsequent absorption of all nutrients, fats and fat-soluble vitamins being the most clinically relevant.8 Steatorrhea, diarrhea, weight loss, abdominal discomfort, and bloating are hallmarks of EPI. In addition to lifestyle modification (eg, alcohol abstinence, frequent low-volume meals), the typical treatment for EPI is pancreatic enzyme replacement therapy (PERT), the clinical efficacy of which is inconsistent.9 Left untreated, or inadequately controlled, the condition leads to increasingly severe GI symptoms, reduced caloric intake, and inability to gain and/or maintain weight, placing the patient at risk for malnutrition. Malabsorption of fats dramatically increases the risk for malnutrition in patients with EPI.10 Because malnutrition further compromises treatment for the medical conditions underlying EPI, enteral nutrition (EN) becomes a vital therapeutic intervention for stabilizing body mass index (BMI) in some cases.3 EN formulas contain fats as well as carbohydrates, proteins, vitamins, and minerals to help prevent or address nutritional deficiencies related to malabsorption. Nutrition support therapy is more complex than commonly appreciated, particularly when prescribed for patients with EPI. Severely pancreatic insufficient patients are unable to digest and absorb long-chain triglycerides contained in EN formulas – particularly healthy fats such as docosahexanoic acid (DHA) and eicosapentaenoic acid (EPA). Currently, there is no published evidence to support the use of any Food and Drug Administration (FDA)-approved PERT products in enteral feedings, and existing clinical guidelines do not support administration of enzymes by mixing them into EN formulas.3 Factors such as care settings and nutritional formula types must be considered on a case-by-case basis, and complications must be anticipated and avoided; for example, the use of crushed PERT capsule contents in enteral feedings, or capsule contents administered directly though the feeding tube, causes tube clogging and requires frequent monitoring.11 From the patient perspective, some with CF rely on nocturnal EN for adequate caloric intake to maintain and hopefully improve BMI and lung function. Following pancreatic and other GI surgeries, EN is essential for patients who experience gastroparesis and are unable to tolerate oral meals. Lacking an appetite for food, patients with pancreatic cancer often use EN to prevent cachexia. EN is helpful for some patients with cerebral palsy who experience pain while eating solid food.

Developing educational modules to enhance care of aged and dying inmates: Set-up phase.

The purpose of this article is to explain the strategies used in the "Set-up" phase of developing computer-based education on the care and management of incarcerated people who are older and/or dying. Public health nurses have an opportunity to support efforts in educating corrections staff to enhance health care for older and dying inmates. Such endeavors can promote social justice through inmates receiving evidence-based care that parallels that received by the community at large. "Set-up" is the first of four phases in the Institute for Healthcare Improvement's Framework for Going to Full Scale. Our design approach was threefold and included an environmental scan, a modified Delphi survey, and a usability study. An expert advisory board was consulted throughout the Set-up Phase. Participants for the Delphi Survey had expertise in geriatrics and corrections health care. Usability testing was conducted at two State Correctional Institutions. The Delphi Survey consisted of three Qualtrics surveys. Usability testing examined navigability; detected problems; observed time spent solving problems; identified problem severity; and developed recovery strategies. The Set-up established proof of concept, three prototype modules, and a specifications document to guide future programming. In addition, a Technology Niche Analyses® provided a preliminary commercialization plan (NIH, 2017). The Set-up phase has been instrumental in exposing the available infrastructure for dissemination of an educational product within corrections and may be a first step in addressing public health concerns on issues in aging. Commercial feasibility of the program and the need for continued research for Developing the Scalable Unit were established.

Psychiatric reform needs good planning-anational, federal, and regional responsibility

While the German mental health system is extensive and well differentiated, at the same time it is fragmented and lacks coordination. Services do not necessarily follow regional demand. They are not sufficiently integrated into the local social infrastructure. Competition and market mechanisms obstruct cooperation in regional networks. Service management proposed by the 1975 German psychiatric reform ("enquete") has proven to be dysfunctional.This article explores the question of what is necessary to allocate available resources for treatment and care according to modern service concepts and both ethical and professional standards adequately.Based on several years of observation and of playing an active part on the national, federal, and local level, this paper presents concepts of coordination and planning of community mental health services over the last 40years. As aresult, four topics of mental health service planning are presented: individual need for support, institutional quality development, regional networking, and political frameworks.More than ever, psychiatric reform is in need of good planning. Asuggested concept integrates the following: (1)good planning of individual assistance, (2)organizational development of mental health services, (3)cooperation in regional networks, and (4)apolitical framework. Thus, national, federal, and regional activities should be sustainably aligned. We recommend aworking group integrating national, federal, and regional policy makers - backed by atrialogic expert advisory board.

Quality management for academic laboratories: burden or boon? Professional quality management could be very beneficial for academic research but needs to overcome specific caveats.

EMBO Reports (2018) e47143 Basic and translational biomedical research explores biological and pathophysiological mechanisms with the aim of developing novel therapies, preventive measures, and diagnostics to improve human health. Disappointingly, however, most new therapies fail when they are tested in clinical trials. Although the causes of this “translational attrition” are diverse and often rooted in the complexity of the underlying biology, it has also become clear that methodology is a major issue. The “translational roadblock”, along with what has been dubbed a “reproducibility crisis” [1], has fueled discussions about the reliability and reproducibility of biomedical research in general. There is strong evidence that weaknesses in planning, conducting, analyzing, and (non)reporting of research [2], as well as misidentification or contamination of reagents, biologicals, and cell lines [3], are prevalent factors. Meta‐research has shown that these problems can lead to an inflation of effect size and false positives and consequently decrease the reproducibility and predictiveness of research results. At the same time, the increasing methodological complexity combined with the immense proliferation in research outputs greatly complicates the production and evaluation of reliable evidence. Pressure to publish and hypercompetition for resources further compromise the robustness and rigor of research. Arguably, basic and translational biomedical research has a quality problem. In the 1970s, US cars had major quality problems. By comparison, Japanese cars were much more reliable. The introduction of rigorous quality management in the production process was largely credited for this competitive advantage, which helped the Japanese car industry to dominate the market for decades to come. By now, most industries, including US car manufacturers, the health and pharmaceutical industries as well as clinical medicine, have established sophisticated quality management systems (QMS) on which they spend several percent of their budget. Clearly, these investments pay off as companies …

Überlegungen des Expertenbeirats zu Anträgen im Rahmen des Innovationsfonds

The “Innovation Fund” provides incentives for the development and testing of healthcare innovations in the area of the statutory health insurance with the aim to improve the quality of care in Germany. Over a period of initially four years (2016-19), 300 million Euro will be allocated annually to projects on “innovative forms of healthcare provision” and “health services research”. Using a formalized procedure, the ten-member expert advisory board appointed by the German Federal Ministry of Health (BMG) assess all applications on the basis of various criteria for scientific quality, potential of innovation, relevance for health service delivery, and implementability. The present discussion paper sets out important considerations for submission and assessment and puts them up for discussion.(As supplied by the authors)

Integrating Palliative Care Into the Care of Neurocritically Ill Patients: A Report From the Improving Palliative Care in the ICU Project Advisory Board and the Center to Advance Palliative Care.

To describe unique features of neurocritical illness that are relevant to provision of high-quality palliative care; to discuss key prognostic aids and their limitations for neurocritical illnesses; to review challenges and strategies for establishing realistic goals of care for patients in the neuro-ICU; and to describe elements of best practice concerning symptom management, limitation of life support, and organ donation for the neurocritically ill. A search of PubMed and MEDLINE was conducted from inception through January 2015 for all English-language articles using the term "palliative care," "supportive care," "end-of-life care," "withdrawal of life-sustaining therapy," "limitation of life support," "prognosis," or "goals of care" together with "neurocritical care," "neurointensive care," "neurological," "stroke," "subarachnoid hemorrhage," "intracerebral hemorrhage," or "brain injury." We reviewed the existing literature on delivery of palliative care in the neurointensive care unit setting, focusing on challenges and strategies for establishing realistic and appropriate goals of care, symptom management, organ donation, and other considerations related to use and limitation of life-sustaining therapies for neurocritically ill patients. Based on review of these articles and the experiences of our interdisciplinary/interprofessional expert advisory board, this report was prepared to guide critical care staff, palliative care specialists, and others who practice in this setting. Most neurocritically ill patients and their families face the sudden onset of devastating cognitive and functional changes that challenge clinicians to provide patient-centered palliative care within a complex and often uncertain prognostic environment. Application of palliative care principles concerning symptom relief, goal setting, and family emotional support will provide clinicians a framework to address decision making at a time of crisis that enhances patient/family autonomy and clinician professionalism.

Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk.

To determine which medications are most commonly used by women in the first trimester of pregnancy and identify the critical gaps in information about fetal risk for those medications. Self-reported first-trimester medication use was assessed among women delivering liveborn infants without birth defects and serving as control mothers in two large case-control studies of major birth defects. The Teratology Information System (TERIS) expert Advisory Board ratings of quality and quantity of data available to assess fetal risk were reviewed to identify information gaps. Responses from 5381 mothers identified 54 different medication components used in the first trimester by at least 0.5% of pregnant women, including 31 prescription and 23 over-the-counter medications. The most commonly used prescription medication components reported were progestins from oral contraceptives, amoxicillin, progesterone, albuterol, promethazine, and estrogenic compounds. The most commonly used over-the-counter medication components reported were acetaminophen, ibuprofen, docusate, pseudoephedrine, aspirin, and naproxen. Among the 54 most commonly used medications, only two had "Good to Excellent" data available to assess teratogenic risk in humans, based on the TERIS review. For most medications commonly used in pregnancy, there are insufficient data available to characterize the fetal risk fully, limiting the opportunity for informed clinical decisions about the best management of acute and chronic disorders during pregnancy. Future research efforts should be directed at these critical knowledge gaps.

Welche Fehler machen Hausärzte? Daten der Gutachter-Kommission der Landesärztekammer Baden-Württemberg

In Germany, medical error reporting systems are well established. They collect information reported principally by physicians. Systematic data collection concerning medical errors is also performed by expert arbitration and advisory boards of the German State Medical Associations. Data base MERS (Medical Error Reporting System); cases from the Expert Arbitration and Advisory Board of the State Baden-Württemberg from the years 2004-2011 (8,042 cases) were evaluated as follows: extraction of the cases from general practitioners (n=307, 4%); categorisation of the type of error and degree of severity; classification according to ICD-10 (International Classification of Diseases); overview of confirmed cases including commentaries of the above board; logistic regression analysis of factors potentially associated with confirmed cases. In 26% (n=80) the board confirmed medical errors. 55% of the errors were assigned to the category "diagnosis" (n=44), 21% to "general therapy" (n=17), 8% to "operative therapy" ("minor surgical operations") (n=6) and 10% to "injections" (n=8). 29% of cases (n=23) were associated with permanent damage or death. The majority of cases could be assigned to ICD-10 categories "I" (cardiovascular system, n=20) and "S-T" or "V-Y" (consequences of external causes or external causes of morbidity and mortality, n=34). No significant associations were found by logistic regression analysis. The rate of confirmed cases corresponds with the rate of all medical disciplines. The presented overview is illustrative and may be of help to avoid errors by using it for continuing medical education.