Committee Opinions Research Articles

Maximizing virtual meetings and conferences: a review of best practices.

PurposeIn the current COVID-19 pandemic, it is more important than ever to maximize communication in the scientific and medical community. In the context of academic meetings and conferences, there is the growing need for a set of guidelines secondary to the COVID-19 pandemic, and the growing environmental and economic challenges that large academic and medical conferences face. These Virtual Meetings Best Practices were established in response to the scant evidence and guidance on the topic.MethodsThese best practice guidelines were developed from a scoping review of peer-reviewed literature, grey literature and lay literature. MEDLINE and Embase databases were scoped for relevant, non-duplicate articles. For lay articles, Google searches were utilized. The recommendations that comprise this document are a compilation of nonexperimental descriptive studies (e.g. case studies) and expert committee reports, opinions and/or experience of respected authorities, and lay articles.ResultsWe identified four phases of the meeting cycle: Pre-planning considerations, Planning, Accomplishing conference goals through execution, gauging Response and Engaging the target audience for future cycles (PrePARE). Akin to the Plan, Do, Study, Act Cycle of quality improvement interventions, this document is meant to drive meaningful initial and subsequent interventions in the meetings of the medical and academic community. This covers actions and preparation for registration, scheduling, speakers, attendees, event type, technology, monetization/marketing, dealing with disruptions, post-event deliverables, response and engagement strategies. Enhanced access to integrated, high-quality and efficient virtual meetings will establish a new norm as an effective alternative for innovative health research, education and information dissemination in orthopaedics and beyond.ConclusionsGiven the uncertainty of whether large in-person gatherings will be permitted, advisable or responsible later into the summer of 2020 and beyond, these guidelines will aid events being converted and scheduled as virtual-only meetings. As we move forward in the era of increased utility and utilization of virtual conferencing, these guidelines will serve as a benchmark and standard for surgeons in the field.Electronic supplementary materialThe online version of this article (10.1007/s00264-020-04615-9) contains supplementary material, which is available to authorized users.

Intention to treat: obstetrical management at the threshold of viability

Despite medical advances in the care of extremely preterm neonates and growing acceptance of resuscitation at 23 and even 22 weeks gestation, controversy remains concerning the use of antepartum obstetric intervention s that are intended to improve outcomes in the setting of anticipated extremely preterm birth. In the absence of demonstrated benefit at <23 weeks gestation and with uncertain benefit at 23 weeks gestation, previous obstetric committee opinions have advised against their use at these gestational ages. The purpose of this study was to review the use of obstetric intervention s at the threshold of viability based on neonatal resuscitation plan and to review the odds of survival to neonatal intensive care unit discharge based on use of obstetric intervention s with adjustment for neonatal factors. This retrospective study of 6 study centers reviewed pregnant patients who were admitted between 22+0/7 and 24+6/7 weeks gestation facing delivery from 2011-2015. Patients with known anomalies or missing data were excluded. Records were reviewed for demographics, resuscitation plan, and obstetric intervention s. Mode of delivery, delivery room care, and final infant dispositions were recorded. Multiple gestations were included as 1 pregnancy in regard to the use of obstetric intervention s and were excluded from survival analysis. Four hundred seventy-eight mothers met the inclusion criteria. When resuscitation was planned, mothers were more likely to receive all conventional obstetric intervention s (antenatal steroids, magnesium sulfate for neuroprotection, tocolytics, and Group Beta Streptococcus prophylaxis), regardless of gestational age at admission, and were more likely to be delivered by cesarean section (P<.05). Analyzed as a group, when antenatal steroids, magnesium sulfate, tocolytics and Group Beta Streptococcus prophylaxis were administered, the odds of survival to neonatal intensive care unit discharge increased for newborn infants who were born at 22 (odds ratio, 11.33; 95% confidence interval, 1.405-91.4) and 23 weeks gestation (odds ratio, 15.5; 95% confidence interval, 3.747-64.11; P<.05). In singletons, the odds of survival to neonatal intensive care unit discharge was not improved by cesarean delivery vs vaginal delivery, even after adjustment for the use of additional interventions, weight, gender, and gestational age (odds ratio, 1.0; 95% confidence interval, 0.59-1.8; P=.912). In this study, when postnatal resuscitation was planned at 22 and 23 weeks gestation, women were more likely to receive antenatal steroids, magnesium sulfate, and antibiotics; provision of this bundle imparted survival benefit at 23 weeks gestation but could not be demonstrated at 22 weeks gestation because of the small sample size. These findings support of neonate-oriented obstetric interventions in the setting of delivery at 23 weeks gestation when resuscitation is planned and further exploration of optimal obstetric care when resuscitation of infants who were born at 22 weeks gestation is anticipated.

Committee Opinions and Treasury Regulation: Tax Lawyer Ethics, 1965–1985

At the beginning of the 21st century, tax lawyers are subject to complex and technical professional regulation. While the incremental changes in this regulation often prompt considerable debate at the time the change emerges, the intellectual history of those debates and changes has only recently begun to be written. In a prior article, I explored these developments in the period 1945-1965, documenting a tax professionalism that tended to be patriotic, philosophical, and pragmatic. In this Article, I turn to the subsequent 20 years, documenting the domination of the professional debates by committees and the ascent of a significantly more constrained and technically oriented professionalism.

Congenital Heart Disease: Prenatal Diagnosis and Genetic Associations.

Congenital heart disease (CHD) is a common cause of neonatal morbidity and mortality. Several genetic abnormalities have been linked to congenital cardiac disease. When diagnosed prenatally, appropriate evaluation can help optimize neonatal outcomes. The objective of this review is to identify appropriate prenatal genetic testing when congenital cardiac defects are identified antenatally. This review also identifies specific congenital cardiac defects that are associated with fetal aneuploidy and genetic syndromes. A MEDLINE search of "genetic testing" or "microarray" and "congenital heart disease" and specific conditions reported in the review was performed. The evidence cited in this review includes case reports or case series (4) textbooks (3), systematic reviews (1), expert committee opinions (10), and 37 additional peer-reviewed journal articles that were original research or expert summaries. When CHD is identified through prenatal screening, patients should be referred for genetic counseling and offered appropriate genetic testing. Prenatal diagnosis of genetic syndromes related to CHD and close communication between obstetric, genetic, and pediatric providers can help optimize outcomes for both mother and baby.

Évaluation de l’utilisation par les pharmaciens hospitaliers des avis émis par la Haute Autorité de santé et des outils économiques qui leur sont proposés

In French hospitals, the supply and management of drugs are missions of pharmacists. The aim of this study is to assess the use of efficacy and economics opinions of the Haute Autorite de santé (HAS) in hospital referencing of drugs in France in 2017. A questionnaire for hospital pharmacists was developed to establish their knowledge and their uses of Transparency Commission and Economic and Public Health Evaluation Committee opinions. This survey was distributed by the ADIPH association in July 2017. This questionnaire included 35 questions. Despite the health professional are more and more interesting by economics analysis, only 30% of hospitals pharmacists of this panel declared to use HAS economic opinions (versus 80% for Transparency Commission opinions). Among these pharmacists, 86% used this report in the hospital referencing of drugs. Through this analysis, some prospects for improvement can be seen in the health professional formation, cost-effectiveness report publication and the use of cost-effectiveness analysis. This study is an overview of the use of opinions provided by the HAS. This thesis established a basis to reflection on the use of economics reports and models in the hospital decisions.

Clinical added value of drugs: An empirical survey of French transparency committee opinions

To identify criteria used by French health authorities to assess the clinical added value (ASMR) of drugs seeking reimbursement. We conducted a systematic review of the opinions of the transparency committee (TC) of the French national authority for health (HAS) between March, 2014 and October, 2016 in ten therapeutic areas. TC opinions content was coded and analysed using descriptive statistics and logistic models. The database comprised 160 opinion texts, which included ASMR assessments using a 5 level scale (1=highest ASMR 5=no ASMR). Main elements that were linked with ASMR 1,2,3,4 as compared to ASMR 5 were appraisal of the medical need, population size (<5000 patients), and clinical relevance of the evaluated results. The factors associated with ASMR 4 as compared to ASMR 1-3 were the safety profile and clinical relevance of the results. However, the factors associated with ASMR level varied according to the therapeutic area considered. The assessment of the drug ASMR conducted by the French transparency commission of the HAS appears to be at least in part determined by criteria (medical need, population size) which reflect the burden of the disease but not reflect the ASMR of the medicine assessed. Other criteria used for the assessment of ASMR are not clearly defined and depend on the therapeutic domain. The lack of sufficient clarity and consistency in assessment of ASMR complicate the decision making process for drug development. Moreover, this situation can be a barrier for a harmonized process of ASMR assessment at European level.

PSY109 - WHAT INTERPRETATION OF ICERS IN ORPHAN DISEASES? A FRENCH EXAMPLE

In France, the cost-effectiveness analysis (CEA) submitted by manufacturers, to the French National Authority for Health (HAS), is reviewed by the Committee of Economic and Public Health (CEESP) which then leads to an “efficiency opinion”. ICERs from these economic evaluations allow the price fixing. However, the interpretation of ICERs is difficult in particular in the case of orphan diseases due to no willingness to pay threshold value and no characterized level of ICERs. The aim of this study is to assess ICERs of orphan diseases and critiques issued by the CEESP. This study was based on a developed database analyzing available “efficiency opinion” issued by the CEESP. This IQVIA board allows to analyze ICERs of orphan drugs and critiques issued by the CEESP. Orphan drugs were identified through transparency committee opinions. In France, 58 efficiency reports were published by the HAS between 2014 and 2018 including 12 orphan drugs in different therapeutic area: haematology treatments (N=4), cardiology treatments (N=2), oncology treatment (N=1), pneumology treatment (N=1), endocrinology treatment (N=1) and a musculoskeletal treatment (N=1). ICERs of orphan drugs ranged from 33,127€/QALY to 2,661,514€/QALY. Among the 4 heamatology drugs, only defibrotide was cost-effective with an ICER of 33,273€/QALY. For cardiology treatments, macitentan and riociguat indicated in pulmonary arterial hypertension had ICERs of 85,359€/QALY and 108,876€/QALY, respectively. However, only two ICERs of orphan drugs from French cost-effectiveness analyses have been criticized. These drugs were riociguat with an ICER of 108 876€/QALY and nusinersen sodium with an ICER of 2,661,514€/QALY. Both ICERs were considered extremely high by the CEESP despite no characterized level of ICERs. Although, no willingness to pay threshold value is clearly specified in France in 2018, efficiency opinions may be used by the Economic Committee for Medicinal Products (CEPS) for the price fixing.

Establishing the global working group on Reproductive and Developmental Environmental Health (RDEH): practicum of a global resource.

Advocacy, training, and research for the prevention of adverse health effects from environmental exposure are the major foci of the International Federation of Gynecology and Obstetrics (FIGO) Reproductive and Developmental Environmental Health (RDEH) Working Group. A critical need for a consistent global effort to address these threats to human reproductive and developmental health was identified after the publication of influential committee opinions (ACOG, Obstet Gynecol, 2013; FIGO, Int J Gynaecol Obstet, 2015) and the assembling of the FIGO 2015 Pre-Congress Workshop, “Summit on Shaping Our Planetary Legacy: Setting an Agenda for Environmental Reproductive Health.” RDEH’s goals are to convene experts of diverse backgrounds to generate evidence-based knowledge and propose solutions to the increasing threats of harmful environmental chemicals to global human reproduction and development by prevention of harm through education, research, and advocacy. This practicum is a guide for establishing a global task force, such as FIGO RDEH, for developing collaboration among experts across disciplines and time zones, and for building accessible and vital databases.

First look at new 2018 joint ESH/ESC Guidelines on diagnosis and management of hypertension

Systemic hypertension (HTN) is the most prevalent non-communicable disease and the leading cause for major cardiovascular events, renal failure and cognitive decline. The World Health Organization showed that HTN is a key area of concern for healthcare and identified this condition as one of the primary targets for intervention to reduce global morbidity and mortality. The hard-hitting AHA/ACC Guidelines on management of High blood pressure in adults published in 2017 shocked medical community and enforced reconsidering overall significance HTN once again due to the large pool of newly diagnosed individuals and higher healthcare costs. Ensuing debates around Task Force committee opinions were fomenting at every scientific session related to cardiac diseases throughout first half-year 2018 and beyond the lecture halls as well. Thus all attendees at the 28th European Congress on Hypertension and Cardiovascular Protection held in Barcelona, Spain in June were captivated with the European expert’s presented preview of the new 2018 ESH/ESC joint clinical Guidelines on diagnosis and management of HTN. This short review highlights the bullet points presented before fulltext publication. The chapters on diagnosis, risk stratification, blood pressure treatment target ranges had undergone minor but crucial corrections. Key changes include medical treatment of uncomplicated HTN and drug therapy in special groups with major comorbidities, management of resistant HTN, device-based HTN therapy and adherence interventions.

OBGYN screening for environmental exposures: A call for action.

BackgroundPrenatal exposures have known adverse effects on maternal and neonatal outcomes. Professional societies recommend routine screening for environmental, occupational, and dietary exposures to reduce exposures and their associated sequelae.ObjectiveOur objective was to determine the frequency of environmental exposure screening by obstetricians and gynecologists (OBGYNs) at initial patient visits.Study designPracticing OBGYNs were approached at the University of Colorado and by social media. The survey instrument queried demographics, environmental literacy, and screening practices. Statistical analysis was performed using Chi-square and two-sample t-test.ResultsWe received 312 online survey responses (response rate of 12%). Responding OBGYNs were predominantly female (96%), board-certified (78%), generalists (65%) with a mean age of 37.1 years. Fewer than half of physicians screened for the following factors: occupational exposures, environmental chemicals, air pollution, pesticide use, personal care products, household cleaners, water source, use of plastics for food storage, and lead and mercury exposure. Eighty five percent of respondents reported that they did not feel comfortable obtaining an environmental history and 58% respondents reported that they performed no regular screening of environmental exposures. A higher frequency of screening was associated with > 4 years of practice (p = 0.001), and having read the environmental committee opinion (p = <0.001).ConclusionThe majority of OBGYNs did not incorporate screening for known environmental exposures into routine practice. Reading the environmental committee opinions was strongly and significantly associated with a higher rate of screening. Improving physician comfort in counseling patients may enhance screening for exposures that affect reproductive health.

Carrier screening. Disease prevention vs cost effectiveness

Patients come to fertility specialists to increase the probability of having a healthy child. According to the Online Mendelian Inheritance of Man there are nearly 24,000 heritable disease and phenotypes with which physicians and patients must contend. The American College of Obstetricians and Gynecologists have recently published committee opinions which add expanded carrier screening as an acceptable and recommended method of preconception screening. This allows traditional methods of ethnic based screening to be supplanted by more universal methods. In the face of data which shows that self-reported ethnicity can change with time and is impacted by the individual's culture, religion, language, behavior and psychology, this takes an uncertain factor off the table for patients and providers. Further, in the era of increased cost efficiency in genomic medicine, expanded carrier screening presents an increasingly cost effective method of preconception counseling. The curation of these panels needs to be an area of great focus and continued maintenance. It is recommended that these conditions have a carrier frequency of >1:100, have a well-defined phenotype, have a detrimental effect on quality of life, cause cognitive or physical impairment, require surgical or medical intervention, and have early onset in life. As we continue to discover new genetic causes of disease these panels will inevitably evolve. The identification of carrier status in couples allows for enhanced clinical decisions to be made. This includes options such as preimplantation genetic diagnosis, use of donor gametes, adoptions, or even a discussion about discontinuing effort to build a family. Traditionally utilization of PGD in at risk couples has been low given the limits of IVF including time, low success rates, high cost, and multiple gestation risk. However, with modern IVF, many of these concerns are greatly diminished allowing for more access to couples to this technology. For the clinician, this paradigm which avoids the need for ethnic based assessment allows for improved liability coverage and presents a cost effective approach to care when the cost of traditional screening methods in addition to the healthcare savings when heretofore undiagnosed carrier states result in an affected child are calculated. Reducing the burden to both patients and providers will likely lead to continued increased utilization in preconception care.

What's New in Prenatal Genetics? A Review of Current Recommendations and Guidelines.

The rapid development of prenatal genetic testing and screening tools and choices constantly challenges clinicians to stay up to date on current best practice. We sought to review, compare, and summarize recent national society guidelines on prepregnancy genetic screening and prenatal diagnosis for aneuploidy with a focus on changes and additions to previous guidelines. We performed a descriptive review of 8 recently published (2016-2017) national guidelines and updates on prenatal genetic screening and testing including American Congress of Obstetricians and Gynecologists committee opinions and practice bulletins, Society for Maternal-Fetal Medicine consult series publications, and an American College of Medical Genetics and Genomics position statement. Topics included carrier screening, cell-free DNA screening, chromosomal microarray analysis, next-generation sequencing, and prenatal diagnostic testing. The recommendations in these publications were compared, and the additions and changes to previous recommendations and guidelines were summarized. Recent publications contain many updates and changes to previous screening and testing strategies, most of which are consistent between professional societies. Although many new technologies have been integrated into prenatal diagnosis, some newer technologies are not yet routinely recommended for widespread use, often because of lack of clinical trials and validation studies. Prenatal screening and testing options are rapidly expanding. To provide best-practice prenatal care, obstetric care providers should educate themselves about the most up-to-date recommendations and be prepared to interpret and apply these guidelines to their patients. Society guidelines are largely in agreement.

An OPT-OUT approach to expanded carrier screening (ECS) informs patient and clinician decision making and identifies more preimplantation genetic diagnosis (PGD) appropriate cases

Patients seek fertility care to increase the probability of having a healthy child. ACOG recently published committee opinions which highlight the use of ECS in the era of genomic medicine as a crucial part of preconception counseling that should be offered before a pregnancy is conceived. For patients seeking infertility care a unique opportunity exists for this counseling, screening, and, if appropriate, treatment in the form of PGD. We sought to determine whether an opt-in or an opt-out approach to ECS identified more carriers and PGD appropriate cases.

The environmental injustice of beauty: framing chemical exposures from beauty products as a health disparities concern

The obstetrics-gynecology community has issued a call to action to prevent toxic environmental chemical exposures and their threats to healthy human reproduction. Recent committee opinions recognize that vulnerable and underserved women may be impacted disproportionately by environmental chemical exposures and recommend that reproductive health professionals champion policies that secure environmental justice. Beauty product use is an understudied source of environmental chemical exposures. Beauty products can include reproductive and developmental toxicants such as phthalates and heavy metals; however, disclosure requirements are limited and inconsistent. Compared with white women, women of color have higher levels of beauty product-related environmental chemicals in their bodies, independent of socioeconomic status. Even small exposures to toxic chemicals during critical periods of development (such as pregnancy) can trigger adverse health consequences (such as impacts on fertility and pregnancy, neurodevelopment, and cancer). In this commentary, we seek to highlight the connections between environmental justice and beauty product-related chemical exposures. We describe racial/ethnic differences in beauty product use (such as skin lighteners, hair straighteners, and feminine hygiene products) and the potential chemical exposures and health risks that are associated with these products. We also discuss how targeted advertising can take advantage of mainstream beauty norms to influence the use of these products. Reproductive health professionals can use this information to advance environmental justice by being prepared to counsel patients who have questions about toxic environmental exposures from beauty care products and other sources. Researchers and healthcare providers can also promote health-protective policies such as improved ingredient testing and disclosure for the beauty product industry. Future clinical and public health research should consider beauty product use as a factor that may shape health inequities in women's reproductive health across the life course.

French Health Technology Assessment of Antineoplastic Drugs Indicated in the Treatment of Solid Tumours: Perspective for Future Trends.

BackgroundFrance is one of the European countries that spend the most on oncology drugs. To keep pharmaceutical expenditure under control, Health Authorities highly scrutinize market access of costly medicines.ObjectiveTo assess current and future trends in French health technology assessment (HTA) of antineoplastic drugs indicated in the treatment of solid tumours.MethodsA review of the SMR and ASMR drivers of the Transparency Committee (CT) opinions issued for antineoplastic drugs indicated in the treatment of solid tumours and approved between 2009 and 2014 was performed to assess current trends in French health technology assessment (HTA), complemented by an expert board consultation to capture the critical issues on the future of antineoplastic drugs HTA.ResultsThirty-one drugs indicated for the treatment of solid tumours were identified (77 % targeted therapies). Initial CT assessments were available for 26 drugs. Four key items in the CT assessment were identified: 1) Clinical trial methodology; 2) Acceptance of progression-free survival (PFS) as a valuable endpoint; 3) Transferability of clinical trials in clinical practice; 4) Unpredictability of CT decisions. Experts raised the important development of personalised medicines in oncology and key challenges for oncology products to generate information expected from HTA perspective.ConclusionThe French system remains committed to its values and philosophy (access of all innovations for everybody) which are threatened by the increasing launch of innovative therapies and budget constraint. Both HTA decision framework evolution and revision of the current pricing process should be considered in France to cope with these new challenges.Electronic supplementary materialThe online version of this article (doi:10.1007/s11523-015-0411-8) contains supplementary material, which is available to authorized users.

Improving Clinical Practice Guidelines for Practicing Cardiologists

Cardiac-related clinical practice guidelines have become an integral part of the practice of cardiology. Unfortunately, these guidelines are often long, complex, and difficult for practicing cardiologists to use. Guidelines should be condensed and their format upgraded, so that the key messages are easier to comprehend and can be applied more readily by those involved in patient care. After presenting the historical background and describing the guideline structure, we make several recommendations to make clinical practice guidelines more user-friendly for clinical cardiologists. Our most important recommendations are that the clinical cardiology guidelines should focus exclusively on (1) class I recommendations with established benefits that are supported by randomized clinical trials and (2) class III recommendations for diagnostic or therapeutic approaches in which quality studies show no benefit or possible harm. Class II recommendations are not evidence based but reflect expert opinions related to published clinical studies, with potential for personal bias by members of the guideline committee. Class II recommendations should be published separately as "Expert Consensus Statements" or "Task Force Committee Opinions," so that both majority and minority expert opinions can be presented in a less dogmatic form than the way these recommendations currently appear in clinical practice guidelines.

Noninvasive prenatal testing in China: Future detection of rare genetic diseases?

Noninvasive prenatal testing (NIPT) provides an innovative method to detect genetic conditions in fetuses using a maternal blood sample, thus avoiding the risk of miscarriage associated with traditional invasive procedures. Since 80% of rare diseases are genetic diseases, NIPT has the potential to detect rare genetic diseases early on and it has been used in many countries and regions. Since China has the world's largest population of patients with rare diseases, NIPT has been implemented in China since 2010. However, the regulations governing NIPT in China are weak and NIPT oversight and research are still lacking. Strict registration is needed to ensure the quality of NIPT, additional certification can help a developer/manufacturer of an NIPT test to compile clinical data and to improve innovation, and academic societies can provide committee opinions that are suited to the current situation in China. These efforts may improve regulations governing NIPT and NIPT oversight and research in China. With these improvements, NIPT may offer promise in terms of the early detection of rare diseases.

Timing and extent of thyroid surgery for gene carriers of hereditary C cell disease—a consensus statement of the European Society of Endocrine Surgeons (ESES)

This "consensus statement" aims to summarise the current evidence-based knowledge as to "timing" and planning the "extent" of thyroid surgery in terms of an optimal balance between the prevention of thyroid malignancy (involving metastasis) and the risks associated with more extended surgery (permanent hypoparathyroidism, permanent paralysis of the recurrent laryngeal nerve). Surgery "in time" is influenced by genetic findings and age. Basal (and stimulated) calcitonin levels may individualise the timing and extent of surgery. The review of English-language studies addressing the management of REarranged during Transfection proto-oncogene mutation carriers including the time, extent of thyroid surgery and results. Evidence is mostly obtained from well-designed, non-experimental descriptive investigations, such as comparative, correlation and case-control studies (level III) with a grading of recommendation B, or from expert committee reports or opinions and/or the clinical experience of respected authorities (level IV) with a grading of recommendation C, respectively. "Risk level D" includes multiple endocrine neoplasia 2B cases. Thyroidectomy is recommended within the first year of life, preferably as soon as possible, due to the very early transformation of C cell hyperplasia to more aggressive tumours. Calcitonin levels may be less helpful. In patients with codon 634 mutations (risk level C), thyroidectomy between ages 2 and 4years has been proposed based upon evidence of age-dependent and codon-specific progression of early medullary thyroid cancer. In "risk level B" (codons 609, 611, 618, 620, 630 and 804), tandem mutation (804-778) patients should undergo thyroidectomy before the age of 6years. "Risk level A" includes patients with mutations in codons 321, 515, 533, 600, 603, 606, 635, 649, 666, 768, 776, 790, 791, 804 (single mutation), 833, 844, 861, 891 or 912. Surgery may be postponed until the age of 10years. However, postponing surgery and avoiding central (level VI) neck dissection in patients with risk levels A to C are only justified in families with a less aggressive MTC history and in combination with the results of basal (and calcium- or pentagastrin-stimulated) serum calcitonin levels. The moment of transition from C cell hyperplasia to MTC seems to occur when calcitonin levels rise. In patients with normal basal and stimulated calcitonin levels, the chance of micro-MTC increases significantly. Hereditary C cell disease acts as a model to apply the results of bedside genetic testing, age and calcitonin levels (genotype-age-calcitonin-concept) for the individual timing of thyroid surgery and its extent.

Environmental assessment and exposure control: a practice parameter—furry animals

IaEvidence from meta-analysis of randomized controlled trials IbEvidence from at least 1 randomized controlled trial IIaEvidence from at least 1 controlled study without randomization IIbEvidence from at least 1 other type of quasiexperimental study IIIEvidence from nonexperimental descriptive studies, such as comparative studies IVEvidence from expert committee reports or opinions or clinical experience of respected authorities or both ErratumAnnals of Allergy, Asthma & ImmunologyVol. 109Issue 3PreviewThe list of authors in the article entitled “Environmental assessment and exposure control: a practice parameter—furry animals (Ann Allergy Asthma Immunol 2012;108:223-7.e15)” was incomplete. We have updated the online version of the article with the correct list of authors as follows: Jay M. Portnoy, MD; Kevin Kennedy, MPH; James L. Sublett, MD; Wanda Phipatanakal, MD, MS; Elizabeth Matsui, MD; Charles Barnes, PhD; Carl Grimes, CIEC; J. David Miller, PhD; James M. Seltzer, MD; P. Brock Williams, PhD; Jonathan A. Full-Text PDF

466 Levels of Evidence in Endoscopic Ultrasonography (EUS): A Survey of the Literature

EUS has evolved into a valuable implement of modern clinical practice with critical impact on patients' management. We recorded all the studies on EUS published during the last decade and evaluated them in terms of scientific quality based on levels of evidence (LE). All articles on EUS published between January 2001 and June 2010 were retrieved using a Pubmed search. The following classification was used to determine LE. Ia: meta-analysis of randomized controlled trials; Ib: at least one randomized controlled trial; IIa: at least one well designed controlled study without randomization; IIb: at least one other type of well designed quasi-experimental study; III: well designed non-experimental descriptive studies (comparative studies, correlation studies or case studies); IV: expert committee reports or opinions, or clinical experiences of respected authorities. 1,692 relevant papers constituted the material of our analysis. An overview of the studies, according to the subject and LE, is presented in Table 1.Over the course of the past 10 years a progressively increasing number of publications was recorded. Although the majority comprised retrospective studies, reviews and case series, a considerable number of prospective controlled trials, RCTs and meta-analyses was also noted, especially during the last 5 years. These consolidated the value of EUS in the diagnosis and staging of luminal cancers, documented its efficacy in the pancreatobiliary area and the mediastinum, clarified many of the technical aspects of EUS-FNA, and extended the role of EUS towards therapy (celiac plexus neurolysis, fluid drainage, pancreatic tumor ablation).Table 1Levels of Evidence per SubjectIAIBIIAIIBIIIIVTotalPancreatic tumors and cysts2 (0.5%)6 (1.5%)18 (4.5%)52 (12.5%)224 (53.7%)114 (27.3%)416EUS in general⁎Technical aspects of instrumentation and EUS-fine needle aspiration (FNA), complications, sedation., Experimental studies0 (0%)12 (3.9%)12 (3.9%)44 (14.6%)103 (34.3%)130 (43.3%)301Esophageal, Gastric and Rectal cancer9 (3.6%)4 (1.6%)12 (4.8%)43 (17.2%)119 (47.6%)63 (25.2%)250Emerging and Other indications⁎⁎Liver, adrenals, kidneys, celiac ganglia, Barrett's, Crohn's, gastric ulcer, sarcoidosis, ascites.0 (0%)2 (1.4%)10 (7%)37 (26.1%)73 (51.4%)20 (14%)142Extrahepatic biliary tree4 (2.9%)4 (2.9%)17 (12.3%)28 (20.3%)50 (36.2%)35 (25.4%)138Therapeutic EUS2 (1.7%)5 (4.2%)2 (1.7%)14 (11.9%)53 (44.9%)42 (35.6%)118Lung cancer, mediastinum, lymph nodes2 (1.7%)2 (1.7%)12 (10.3%)20 (17.2%)56 (48.3%)24 (20.7%)116Submucosal tumors0 (0%)0 (0%)3 (3.4%)13 (14.6%)53 (59.5%)20 (22.5%)89Chronic and Acute pancreatitis0 (0%)1 (1.2%)8 (9.5%)13 (15.5%)31 (36.9%)31 (36.9%)84Portal hyper tension0 (0%)2 (5.3%)1 (2.6%)11 (28.9%)16 (42.1%)8 (21.1%)38Total19 (1.1%)38 (2.2%)95 (5.6%)275 (16.2%)778 (45.9%)487 (28.8%)1692 Technical aspects of instrumentation and EUS-fine needle aspiration (FNA), complications, sedation. Liver, adrenals, kidneys, celiac ganglia, Barrett's, Crohn's, gastric ulcer, sarcoidosis, ascites. Open table in a new tab The available literature on EUS keeps expanding, encompassing not only its well-established diagnostic role throughout the gastrointestinal tract, but also novel indications and therapeutic interventions. A trend towards well-structured studies, demonstrating the clinical impact of EUS, is now obvious.