ObjectiveWith the growing prevalence of overweight and obesity, medical students should be prepared to engage in weight management and obesity-related communications in order to prevent patients from ...having stigmatising experiences. In addition, medical students should have training to reduce anti-fat prejudices.DesignCross-sectional proof of concept study.SettingUniversity Hospital Tuebingen, Germany.Participants246 participants (207 second-year medical students, 13 standardised patients (SPs) and 22 teachers) took part in the study.Primary and secondary outcome measuresThe primary outcome was the assessment of degree of reality of the encounter with the SP wearing an obesity simulation suit (OSS). The secondary outcome was the evaluation of students’ awareness and prejudice against patients with obesity in a simulated role play. Additionally, a description of the advantages and disadvantages when using such a teaching tool is delivered.ResultsThe OSS contributed to a realistic perception of the patient group depicted in a role play according to students, teachers and SPs. OSS body mass index estimation by students, teachers and SPs correctly was over 30 kg/m2—thus in the range of obesity. In a selected subscale of the Anti-Fat Attitudes Test, students showed significantly stronger anti-fat stigmatisation compared with teachers and SPs.ConclusionsAn OSS worn by an SP is a valuable teaching tool to raise awareness about patients with obesity. It gives a realistic picture of the encounter. Stigmatisation was low in general but was especially present in the students. Further research should include intervention studies to address this issue.
Offers Primary-Care Providers Access to Expert, Current Research and Practice Guidelines Allowing Them to Confidently Support Children Who Present with Symptoms of Autism Coauthored by the premier ...expert on autism in the United States and an experienced academic and practicing pediatrician, this volume provides concise and practical information based on the most up-to-date research and clinical experience for primary caregivers around the world. In an environment full of contesting theories and advice, this book provides the gold standard of current research and practice for primary care providers Shows clinicians how to most effectively use evidence-based techniques Links to video lectures by Dr. Volkmar provided Topic covered include: Screening and Diagnosis Associated Medical Conditions Providing Medical Care Working with Families and Schools Behavioral Issues and Interventions Medications Changes with Age Did You Know? This book is available as a Wiley E-Text. The Wiley E-Text is a complete digital version of the text that makes time spent studying more efficient. Course materials can be accessed on a desktop, laptop, or mobile device—so that learning can take place anytime, anywhere. A more affordable alternative to traditional print, the Wiley E-Text creates a flexible user experience: Access on-the-go Highlight and take notes Search across content Save money! The Wiley E-Text can be purchased in the following ways: Check with your bookstore for available e-textbook options Directly from: www.wiley.com/x
Next-Generation Risk Assessment (NGRA) aims to implement New Approach Methodologies (NAMs) into risk assessment and to rely on new in vivo testing in animals only as a last resort. However, various ...technical and regulatory hurdles impede their regulatory implementation. Assumptions about the public's expectations could act as barriers to the acceptance of NAMs. This study aimed at investigating public views of animal testing and potential alternatives, namely in vitro and in silico testing. An online survey was conducted (N = 965). The results suggest that people make trade-offs, as they experience negative affect regarding in vivo testing, which partly might explain their openness regarding certain alternatives. In vitro tests were attributed the highest ability to determine harmful effects of chemicals for different endpoints, followed by in vivo and in silico tests. Our results further showed that many people accept chemicals to be only tested with alternatives, with highest acceptance for household consumer products, food contact material or building materials and less accepting for medicines and foods. This article addresses potential challenges that might arise from public perceptions and thus, contributes to the bottom-up initiatives to overcome the hurdles to the implementation of NAMs in regulatory risk assessment.
•Acceptability of in vivo testing was low, but highest for medicine and food.•In vitro tests elicited the highest expected ability to determine harmful effects.•Testing substances with alternatives to in vivo tests did not elicit public concern.•People apply affect and trust heuristics when confronted with different tests.
Healthcare issues for children on the autism spectrum Volkmar, Fred R; Wiesner, Lisa A; Westphal, Alexander
Current opinion in psychiatry,
2006-July, 2006-Jul, 2006-07-00, 20060701, Volume:
19, Issue:
4
Journal Article
Peer reviewed
PURPOSE OF REVIEWWe provide a summary of issues relevant to healthcare and health delivery in autism and related disorders, with a focus on work published in the past 5 years.
RECENT FINDINGSAutism ...has a strong genetic basis as evidenced by the high recurrence rate in families and its associations with Fragile X syndrome and tuberous sclerosis. Early diagnosis of autism is important, given the potential for improvement with intervention. Although its associations have been reported with events such as measles–mumps–rubella immunization, large-scale studies have not supported such links. Controlled drug trials have increased in frequency and drug treatment may be helpful in addressing frequently associated behavioural and emotional difficulties. Alternative treatments are frequently preferred by parents.
SUMMARYKnowledge of autism among healthcare professionals has increased but gaps remain. Physicians and other professionals can facilitate the delivery of healthcare services to individuals with autism. Awareness of empirically validated treatments will facilitate work with individuals with autism and related disorders as well as with their families.
Contract Development and Manufacturing Organizations (CDMOs) that manufacture large, diverse portfolio of chemical and pharmaceutical substances require pragmatic risk‐based decisions with respect to ...the safe carry‐over between different chemical entities, as well as for worker protection. Additionally, CDMOs may not have access to primary study data, or data are generally lacking for a specific substance. While pharmaceuticals require the establishment of health‐based exposure limits (HBELs) (e.g., occupational exposure limits OELs and permitted daily exposure PDE limits), the limits for nonhazardous substances could be set in a protective and pragmatic way by using default values, when internally required. Because there is no aligned definition provided by authorities, nor agreed default values for nonhazardous substances, we provide a decision tree in order to help qualified experts (such as qualified toxicologists) to identify the group of nonhazardous substances and to assign default HBEL values for specific routes of exposure. The nonhazardous substances discussed within this publication are part of the following subgroups: (I) inactive pharmaceutical ingredients, (II) pharmaceutical excipients or cosmetic ingredients, (III) substances Generally Recognized as Safe (GRAS), and (IV) food ingredients, additives, and contact materials. The proposed default limit values are 1 mg/m3 for the OEL and 50 mg/day for the PDE oral and intravenous (IV) route.
Contract Development and Manufacturing Organizations (CDMOs) work with a large, diverse portfolio of pharmaceutical substances, thus, often need a pragmatic approach to apply risk‐based decisions for patient and worker safety during manufacturing in multipurpose facilities. This work provides guidance on identifying and setting default health‐based exposure limits (HBELs) for defined nonhazardous substances in pharmaceutical manufacturing in line with regulatory guidelines.
Over the past 20 years, schistosomiasis control has been scaled up. Preventive chemotherapy with praziquantel is the main intervention. We aimed to assess the effect of preventive chemotherapy on ...schistosomiasis prevalence in sub-Saharan Africa, comparing 2000–10 with 2011–14 and 2015–19.
In this spatiotemporal modelling study, we analysed survey data from school-aged children (aged 5–14 years) in 44 countries across sub-Saharan Africa. The data were extracted from the Global Neglected Tropical Diseases database and augmented by 2018 and 2019 survey data obtained from disease control programmes. Bayesian geostatistical models were fitted to Schistosoma haematobium and Schistosoma mansoni survey data. The models included data on climatic predictors obtained from satellites and other open-source environmental databases and socioeconomic predictors obtained from various household surveys. Temporal changes in Schistosoma species prevalence were estimated by a categorical variable with values corresponding to the three time periods (2000–10, 2011–14, and 2015–19) during which preventive chemotherapy interventions were scaled up.
We identified 781 references with relevant geolocated schistosomiasis survey data for 2000–19. There were 19 166 unique survey locations for S haematobium and 23 861 for S mansoni, of which 77% (14 757 locations for S haematobium and 18 372 locations for S mansoni) corresponded to 2011–19. Schistosomiasis prevalence among school-aged children in sub-Saharan Africa decreased from 23·0% (95% Bayesian credible interval 22·1–24·1) in 2000–10 to 9·6% (9·1–10·2) in 2015–19, an overall reduction of 58·3%. The reduction of S haematobium was 67·9% (64·6–71·1) and that of S mansoni 53·6% (45·2–58·3) when comparing 2000–10 with 2015–19.
Our model-based estimates suggest that schistosomiasis prevalence in sub-Saharan Africa has decreased considerably, most likely explained by the scale-up of preventive chemotherapy. There is a need to consolidate gains in the control of schistosomiasis by means of preventive chemotherapy, coupled with other interventions to interrupt disease transmission.
European Research Council and WHO.
Permitted Daily Exposure Limits (PDEs) are set for Active Pharmaceutical Ingredients (APIs) to control cross-contamination when manufacturing medicinal products in shared facilities. With the lack of ...official PDE lists for pharmaceuticals, PDEs have to be set by each company separately. Although general rules and guidelines for the setting of PDEs exist, inter-company variations in the setting of PDE occur and are considered acceptable within a certain range. To evaluate the robustness of the PDE approach between different pharmaceutical companies, data on PDE setting of five marketed APIs (amlodipine, hydrochlorothiazide, metformin, morphine, and omeprazole) were collected and compared. Findings show that the variability between PDE values is within acceptable ranges (below 10-fold) for all compounds, with the highest difference for morphine due to different Point of Departures (PODs) and Adjustment Factors (AFs). Factors of PDE variability identified and further discussed are: (1) availability of data, (2) selection of POD, (3) assignment of AFs, (4) route-to-route extrapolation, and (5) expert judgement and differences in company policies. We conclude that the investigated PDE methods and calculations are robust and scientifically defensible. Additionally, we provide further recommendations to harmonise PDE calculation approaches across the pharmaceutical industry.
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•Study compares PDE values for five APIs among companies•POD and AF selection impact PDE variability up to 10-fold•Morphine shows highest PDE difference due to diverse data•PDE calculation methods evaluated show robustness and defensibility•Recommendations are presented for harmonizing PDE calculation approaches
Due to newly introduced EU GMP (Good Manufacturing Practice) guideline for Medicinal Products for Human and Veterinary use, product specific permitted daily exposure (PDE) for toxicological ...evaluation in multi-purpose facilities are required within a documented process for risk assessment. European Medicines Agency (EMA) guidance on setting PDE limits so far focused on systemic administration routes such as intravenous (IV), oral or inhalation. This article provides guidance on setting PDE values for risk management purposes in multi-purpose facilities for active pharmaceutical ingredients (APIs) applied as topical otic drugs to the outer ear canal. The therewith determined PDE otic, is used for the calculation of maximum safe carry-over (MSC) in manufacturing scenarios where a topical otic product is manufactured followed by another topical otic product.
Autism is in the public spotlight now more than ever as new research and information appears almost daily. Although in many ways this is a positive development it also presents challenges to families ...and practitioners who want to keep up with the latest developments and are left to sift through new information by themselves to see what is credible and relevant for them.Each of us needs a personal research assistant who can determine which information we need to pay attention to and let us know how it might affect our daily work and the children we are living with or serve.Since we each don’t have our own research assistants on staff, I am delighted to recommend this wonderful book by Fred Volkmar and Lisa Wiesner. Both of these talented professional leaders have combined their scientific skills and understanding of the field with great practical experience and ideas about how research can be translated into clinical practice. The result is a book that provides the best and most comprehensive information about recent scientific developments and a splendid practical guide for how they are being implemented and what we are learning in the process. The issues are presented in all of their complexity but translated into language that is clear, direct, and easy to follow. The format also lends itself to understanding the complex issues and their implications through excellent charts, question and answer sections, and chapters that vary from describing diagnostic issues to stating very specifically how to expand and evaluate the services one is receiving. The comprehensive references and lists of additional resources also add greatly to the overall package.As a professional dedicated to understanding scientific advances and helping families and teachers to utilize them most effectively, I am very pleased to have an ally like this book available. I am very grateful to the authors for providing a very credible, practical, and relevant addition to our field to help the many advocates and family practitioners to better understand the exciting new developments and how they can be implemented in our day to day work. Those taking the time to read through this superb volume will find it time well spent that pays back dividends in many different ways. —FOREWORD by Gary B. Mesibov, Ph.D., Professor and Director of TEACCH, Treatment and Education of Autistic and Related Communication Handicapped Children University of North Carolina at Chapel Hill
Autism in a 15-Month-Old Child Klin, Ami; Chawarska, Katarzyna; Paul, Rhea ...
The American journal of psychiatry,
11/2004, Volume:
161, Issue:
11
Journal Article, Conference Proceeding
Peer reviewed
Autism is a developmental disorder marked by severe deficits in reciprocal social interaction, communication, and imagination as well as repetitive and restricted patterns of interests and behavior. ...Klin et al describe the findings of an interdisciplinary developmental disabilities evaluation of a 15-month-old girl with autism.
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