Relevant Professional Societies Research Articles

Imaging in crystal arthropathies

Crystal arthropathies present a complex entity for radiological diagnostics, often reflecting rheumatologic and other diseases. Over the past decades, the evidence and applicability of various radiological techniques, with and without the use of ionizing radiation, have significantly evolved. This article provides an overview of the current evidence on the use of different modalities and their advantages and disadvantages for the diagnosis and therapy monitoring of crystal arthropathies, based on the latest guidelines from relevant professional societies. In addition to established methods such as X-ray, ultrasound and MRI, this work also addresses newer methods such as dual-energy computed tomography (CT) and photon-counting CT.

Guidelines and regulations applicable to vitro diagnostic tests in the UK: a scoping review

ObjectiveTo describe recommendations applicable to new diagnostic and screening tests brought to market in the UK as of 01 June 2023; and extract agreements, disagreements and gaps.DesignExtant regulations, recommendations and...

Verification of the analytical performance of the serum CA 125 assay on the Abbott Alinity ci®: Experience of the biochemistry laboratory of the Mohammed VI university hospital of Oujda

The aim of our work was to evaluate the analytical performance of CA 125 determination by a two-step immunoassay using microparticle chemiluminescence immunoassay (CMIA) technology, in accordance with the Scope A criteria of the guide of the verification/validation of medical biology methods. We evaluated the repeatability and the intermediate precision of the CA 125 assay.The results obtained are very satisfactory for the three levels (low, medium and high), both for intermediate fidelity, with coefficients of variation (CV) of 2.68%, 1.62% and 2.11% respectively, and for repeatability, with coefficients of variation of CV1 = 2.17%, CV2 = 2.04%, and CV3 = 1.38% respectively. The results obtained made it possible to verify the method's performance and compare it with the analytical objectives set in order to meet the regulatory and normative requirements set by the supplier and learned societies. The achieved results facilitated the verification of the method's performance and its comparison with the analytical objectives established, aligning with regulatory and normative requirements outlined by the supplier and relevant professional learned societies.

Advertisement by medical facilities as an opportunity route of APOE genetic testing in Japan: a website analysis

The APOE-ε4 allele(s) is a strong risk factor for Alzheimer’s disease (AD). A significant point of access for this allele testing is through services provided by medical facilities in Japan, which advertise out-of-insurance APOE testing on their websites. There is a concern that website advertisements for APOE testing may influence the ability for individuals to adequately self-determine whether to undergo APOE testing. We conducted a cross-sectional survey on medical facility websites in Japan advertising APOE genetic testing. We predefined desirable features for advertisement descriptions based on legal regulations and guidelines published by relevant professional societies and evaluated each website according to these features. We identified 220 medical facilities that had posted advertisements on their websites for the provision of APOE genetic testing, of which 85% were small clinics. Contact information, details, and costs of testing were described in most of the websites. Meanwhile, features such as “explaining APOE as a risk gene,” “notes on interpreting APOE results,” or “explaining examination methods” (e.g., blood sampling) were described to a variable degree depending on individual facilities. “Notes on genetic testing” or “referring to genetic counseling” were hardly referred to, and specialists with appropriate expertise were considered to participate in clinical practice in approximately one-third of these facilities providing APOE testing services. These website evaluation results showed moderate to substantial reliability between independent raters. These results suggest that self-determination of pursuing out-of-insurance APOE testing at some medical facilities in Japan may possibly be influenced in an inappropriate manner, at least in its entry route of taking the test.

Interrogating Pharmacogenetics Using Next-Generation Sequencing.

Pharmacogenetics or pharmacogenomics (PGx) is the study of the role of inherited or acquired sequence change in drug response. With the rapid evolution of molecular techniques, bioinformatic tools, and increased throughput of functional genomic studies, the discovery of PGx associations and clinical implementation of PGx test results have now moved beyond a handful variants in single pharmacogenes and multi-gene panels that interrogate a few pharmacogenes to whole-exome and whole-genome scales. Although some laboratories have adopted next-generation sequencing (NGS) as a testing platform for PGx and other molecular tests, most clinical laboratories that offer PGx tests still use targeted genotyping approaches. This article discusses primarily the technical considerations for clinical laboratories to develop NGS-based PGx tests including whole-genome and whole-exome sequencing analyses and highlights the challenges and opportunities in test design, content selection, bioinformatic pipeline for PGx allele and diplotype assignment, rare variant classification, reporting, and briefly touches a few additional areas that are important for successful clinical implementation of PGx results. The accelerated speed of technology development associated with continuous cost reduction and enhanced ability to interrogate complex genome regions makes it inevitable for most, if not all, clinical laboratories to transition PGx testing to an NGS-based platform in the near future. It is important for laboratories and relevant professional societies to recognize both the potential and limitations of NGS-based PGx profiling, and to work together to develop a standard and consistent practice to maximize the variant or allele detection rate and utility of PGx testing.

Summary of the Best Evidence for Nutritional Support in Patients with Acute Gastrointestinal Graft-Versus-Host Disease

[Abstract] Objective: To retrieve, evaluate and integrate the best evidence summary of nutritional support for patients with acute gastrointestinal graft-versus-host disease after hematopoietic stem cell transplantation at home and abroad. Methods: According to the “6S” model, domestic and foreign computer decision support systems, guideline networks, websites of relevant professional societies or institutions, professional books, and comprehensive databases were systematically searched to screen literatures related to nutritional support for patients with acute gastrointestinal graft-versus-host disease, including guidelines, clinical decision-making, evidence summary, expert consensus, expert opinion, systematic review, and original research. The search time limit was from the establishment of the database to March 2023. Five researchers evaluated the quality of the literature, extracted evidence and integrated it. Results: A total of 12 articles were included, including 1 clinical decision, 4 guidelines, 1 evidence summary, 1 expert consensus, 3 systematic reviews, 1 cohort study, 1 expert opinion,. A total of 14 best evidences were summarized from 4 aspects, including scientific diet and tolerance assessment, nutrient selection, nutritional support method selection, and multidisciplinary cooperation. Conclusions: This study systematically integrates the relevant evidence of nutritional support in patients with acute gastrointestinal graft-versus-host disease, and can provide evidence-based evidence for nutritional support in patients with acute gastrointestinal graft-versus-host disease. When applying evidence, it is recommended that clinical nurses comprehensively consider the actual clinical situation and the wishes of patients, and carefully select evidence. Keywords acute gastrointestinal graft-versus-host disease，nutritional support，malnutrition，evidence-based nursing

How are students learning to care for people with disabilities?: exploring the curriculum design of a sample of disability electives offered by US health professions schools

Purpose There is an increased demand among health professions students for disability-focused training. We aimed to characterize the development and structure of a sample of disability electives offered at health professions schools in the United States. Materials and Methods A survey was developed to capture data on the curriculum design of disability electives offered at health professions schools across the United States. The primary outcome measures were elective development, elective structure, learner and instructor demographics, disability inclusion, and evaluation methodologies. A cross-sectional survey study was conducted, during which the survey was distributed to relevant professional societies focused on disability advocacy within healthcare. Results Data were collected on fifteen disability electives. Most electives were developed within the past four years, and many electives were initiated by students. The structure, duration, and evaluation methodology of electives were highly variable. Most electives took the form of a longer didactic-based course or a shorter clinical experience. All electives involved people with disabilities in some capacity. Conclusions Disability electives fill an important gap in disability education at some health professions schools. Elective directors should have an increased focus on assessing student learning and ensuring that people with disabilities are involved in elective design and instruction.

(519) Quantifying Census Demographics and Career Satisfaction Among Urologists Who Treat Male Sexual Health

Abstract Introduction The AUA Census offers broad insight into urology, however, there is limited information reported regarding sub-specialists. We designed a survey to capture similar data among urologists who treat male sexual health, including demographics, clinical practice characteristics, and job satisfaction. Objective To characterize the demographics, practice characteristics and job satisfaction of providers who treat male sexual health. Methods A survey was developed and distributed to all relevant professional urological societies for male sexual health providers, including GURS, ISSM, SMSNA and SUPS. Averages, modes, counts, and ranges were examined. The survey remains open and additional responses are expected. Preliminary analysis as of June 15, 2022, yielded 76 responses; 58 were complete. Results The survey remains open and additional responses are expected. Preliminary analysis as of June 15, 2022, yielded 76 responses; 58 were complete. Demographics: The average age of respondents is 42 years old. 52 (89.6%) respondents self-identify as male, 6 (10.4%) as female. 67% of respondents identify as white (n=39), 7% identify as Asian (n=4), 7% identify as Black or African American (n=4), 2% identify as American Indian/Native American or Alaskan Native (n=1) and 17% preferred not to select a race or selected “other” (n=10); respondents were able to select more than one racial identity. 16% of respondents identified themselves as having Hispanic ethnicity (n=9). 84% of respondents are married (n=49) with 21% divorced or currently going through a divorce (n=12). On average, respondents have 1.5 children (range: 0-3, mode: 2). Work-life: The majority (58%) of respondents work in academic practice (n=34). 19% work in private practice (n=11). Employed physician, multispecialty, solo and hybrid private-VA practices make up the remaining 22% (n=4, 5, 3, 1 respectively). 72% of respondents practice in cities with a population greater than 500,000 (n=42), 12% work in cities with populations between 100,000 – 500,000 (n=7), 14% serve towns of less than 100,00 (n=8). Satisfaction: The survey asked providers binary yes/no questions about career satisfaction. 88% affirmed “I would pursue this career again” (yes, n=51; no, n=7). 69% affirmed “I am satisfied with my current level of compensation” (yes, n=40; no, n=18). 52% affirmed “I am satisfied with my current work-life balance” (yes, n=30; no, n=28). Female responders were significantly more likely to indicate that they are dissatisfied with work-life balance (p=0.0074).100% of female respondents reported dissatisfaction compared to 42% of males. Conclusions To our knowledge, this survey is the first survey exclusively of male sexual health providers. Among survey respondents, the average practitioner is white, male, and married with two children under 18. They are in the first half of their career at an academic institution in an urban area. Although nearly 90% would choose their career again, 50% are dissatisfied with work-life balance. Gender has a significant impact on satisfaction. While averages reflect low diversity within the field, they suggest that gender parity is on track with national trends while racial and ethnic diversity may exceed that of general urology (ref 1). Disclosure No

Whole-course management strategies for gastroesophageal reflux disease: an evidence mapping study based on clinical practice guidelines

Gastroesophageal reflux disease (GERD) is one of the most common digestive diseases with high incidence, complicated clinical symptoms, difficulties in standard treatment, and heavy medical burden. At present, some GERD-relevant clinical practice guidelines (CPGs) have been issued by different countries and academic organizations, but some recommendations were inconsistent, which has caused some problems for the current clinical whole-course management of GERD. To summarize the relevant evidence among the CPGs on GERD and formulate the whole- course management strategies, we included GERD-relevant CPGs published or updated after 2010 by searching websites of guidelines, relevant professional societies, and electronic databases. We extracted the recommendations and summarized the evidence from the aspects of symptoms, epidemiology, diagnosis and treatment, which was presented in the form of evidence mapping. We included 24 CPGs, including three in Chinese and 21 in English. The clinical practice management strategies of GERD were formulated based on the evidence from the aspects of clinical symptoms, diagnostic methods, medical treatment, anti-reflux surgery and endoscopic treatment, psychological treatment, and traditional Chinese medicine treatment.

International Cross-Sectional Survey of Bullying, Undermining, and Harassment in the Vascular Workplace

Bullying, undermining behaviour, and harassment (BUH) may exist in healthcare settings, impacting on patient care. The aim of this international study was to evaluate the characteristics of BUH experienced by physicians treating vascular diseases at various career stages. This was an anonymous international structured non-validated cross-sectional survey distributed via relevant professional societies in collaboration with the Research Collaborative in Peripheral Artery Disease. The survey was disseminated through societies' newsletters, emails, and social media. Data were collected online, allowing free text entries alongside structured multiple choice questions based on previous surveys. Demographics, geographical information, and data relating to stage/environment of training were collected. Of 587 respondents from 28 countries, 86% were working in vascular surgery, mostly at a university hospital (56%); 81% were aged between 31 and 60 years, 57% were working as a consultant, and 23% as a resident. Respondents were mostly white (83%), male (63%), heterosexual (94%), and without disability (96%). Overall, 253 (43%) reported experiencing BUH personally, 75% had witnessed BUH toward colleagues, and 51% witnessed these in the last 12 months. Female sex and non-white ethnicity were associated with BUH (53% vs. 38% and 57% vs. 40% respectively; p < .001 in both cases). While working as consultant, 171 (50%) reported experiencing BUH, more often among females, non-heterosexuals, those who were not working in their country of birth, and non-white people. Specialty and hospital type were not associated with BUH. BUH remains a major problem in the vascular workplace. Female sex, non-heterosexuality, and non-white ethnicity are associated with BUH at various career stages.

The spectrum of pyridoxine dependent epilepsy across the age span: A nationwide retrospective observational study

BackgroundPyridoxine-dependent epilepsy (PDE) is a rare seizure disorder usually presenting with neonatal seizures. Most cases are caused by biallelic pathogenic ALDH7A1variants. While anti-seizure medications are ineffective, pyridoxine provides seizure control, and dietary interventions may be of benefit. As the natural history beyond adolescence is insufficiently explored, our study aimed to assess the spectrum of PDE at various ages in Norway. MethodsPatients were ascertained by contacting all Norwegian paediatric, neurological, and neurohabilitation departments and relevant professional societies. Medical records were collected and reviewed. ResultsWe identified 15 patients treated for PDE; 13 had ALDH7A1 variants (PDE-ALDH7A1), one had PNPO deficiency, and in one, aetiology remained obscure. Of those with PDE-ALDH7A1, 12 were alive at time of study; five were > 18 years old and six were < 4 years. Median age was 10 years (range 2 months–53 years). Estimated minimum prevalence was 6.3/million among children and 1.2/million among adults. Ten had seizure onset on the first day of life. Perinatal complications and neuroradiological abnormalities suggested additional seizure aetiologies in several patients. Pyridoxine had immediate effect in six, while six had delayed (>1 h) or uncertain effect. Median delay from first seizure to continuous treatment was 11 days (range 0–42). Nine experienced breakthrough seizures with intercurrent disease or due to pyridoxine discontinuation. Cognitive outcomes ranged from normal to severe intellectual disability. The condition appeared to remain stable in adult life. SignificanceWe found a much higher prevalence of PDE-ALDH7A1 in children relative to adults, suggesting previous underdiagnosis and early mortality. Perinatal complications are common and can delay diagnosis and initiation of pyridoxine treatment. Lifelong and continuous treatment with pyridoxine is imperative. Due to better diagnostics and survival, the number of adult patients is expected to rise.

Controversy and Consensus on Indications for Sperm DNA Fragmentation Testing in Male Infertility: A Global Survey, Current Guidelines, and Expert Recommendations.

Sperm DNA fragmentation (SDF) testing was recently added to the sixth edition of the World Health Organization laboratory manual for the examination and processing of human semen. Many conditions and risk factors have been associated with elevated SDF; therefore, it is important to identify the population of infertile men who might benefit from this test. The purpose of this study was to investigate global practices related to indications for SDF testing, compare the relevant professional society guideline recommendations, and provide expert recommendations. Clinicians managing male infertility were invited to take part in a global online survey on SDF clinical practices. This was conducted following the CHERRIES checklist criteria. The responses were compared to professional society guideline recommendations related to SDF and the appropriate available evidence. Expert recommendations on indications for SDF testing were then formulated, and the Delphi method was used to reach consensus. The survey was completed by 436 experts from 55 countries. Almost 75% of respondents test for SDF in all or some men with unexplained or idiopathic infertility, 39% order it routinely in the work-up of recurrent pregnancy loss (RPL), and 62.2% investigate SDF in smokers. While 47% of reproductive urologists test SDF to support the decision for varicocele repair surgery when conventional semen parameters are normal, significantly fewer general urologists (23%; p=0.008) do the same. Nearly 70% would assess SDF before assisted reproductive technologies (ART), either always or for certain conditions. Recurrent ART failure is a common indication for SDF testing. Very few society recommendations were found regarding SDF testing. This article presents the largest global survey on the indications for SDF testing in infertile men, and demonstrates diverse practices. Furthermore, it highlights the paucity of professional society guideline recommendations. Expert recommendations are proposed to help guide clinicians.

Controversy and Consensus on the Management of Elevated Sperm DNA Fragmentation in Male Infertility: A Global Survey, Current Guidelines, and Expert Recommendations.

Sperm DNA fragmentation (SDF) has been associated with male infertility and poor outcomes of assisted reproductive technology (ART). The purpose of this study was to investigate global practices related to the management of elevated SDF in infertile men, summarize the relevant professional society recommendations, and provide expert recommendations for managing this condition. An online global survey on clinical practices related to SDF was disseminated to reproductive clinicians, according to the CHERRIES checklist criteria. Management protocols for various conditions associated with SDF were captured and compared to the relevant recommendations in professional society guidelines and the appropriate available evidence. Expert recommendations and consensus on the management of infertile men with elevated SDF were then formulated and adapted using the Delphi method. A total of 436 experts from 55 different countries submitted responses. As an initial approach, 79.1% of reproductive experts recommend lifestyle modifications for infertile men with elevated SDF, and 76.9% prescribe empiric antioxidants. Regarding antioxidant duration, 39.3% recommend 4-6 months and 38.1% recommend 3 months. For men with unexplained or idiopathic infertility, and couples experiencing recurrent miscarriages associated with elevated SDF, most respondents refer to ART 6 months after failure of conservative and empiric medical management. Infertile men with clinical varicocele, normal conventional semen parameters, and elevated SDF are offered varicocele repair immediately after diagnosis by 31.4%, and after failure of antioxidants and conservative measures by 40.9%. Sperm selection techniques and testicular sperm extraction are also management options for couples undergoing ART. For most questions, heterogenous practices were demonstrated. This paper presents the results of a large global survey on the management of infertile men with elevated SDF and reveals a lack of consensus among clinicians. Furthermore, it demonstrates the scarcity of professional society guidelines in this regard and attempts to highlight the relevant evidence. Expert recommendations are proposed to help guide clinicians.

Delabeling penicillin and other antibiotic allergies in solid organ transplantation patients.

Immunocompromised populations including solid organ transplant (SOT) recipients have a high likelihood of need for antibiotic therapy for treatment of infection as well as for prophylaxis. Antibiotic allergy is commonly reported and often leads to the use of alternative, second-line antibiotics, which have been associated with poor outcomes, increased adverse effects, and higher cost. Formal allergy assessment and allergy testing can serve as an important antimicrobial stewardship tool in optimizing antibiotic regimens for this patient population. A PubMed search with relevant keywords was performed. Review of relevant professional society guidelines was also performed. Documented penicillin and sulfonamide allergies are common impediments to the treatment and prophylaxis of immunocompromised populations, but are rarely formally evaluated in practice; however, there is evidence that most patients with documented allergy to these antibiotics can, in fact, tolerate penicillins and sulfonamide antibiotics. Implementation of an antibiotic allergy evaluation and testing program has been shown to increase the use of first-line antibiotics and can be cost saving. Antibiotic allergies have significant clinical consequences, especially in immunocompromised populations. Evaluation of these allergies to prevent the avoidance of first-line antibiotics should be a standard part of the workflow for these patients, prior to transplant. Programs can be tailored to the available personnel and resources of the organization.

Protocol for the development of a core domain set for individuals with ankle osteoarthritis

BackgroundAnkle osteoarthritis (OA) is a debilitating health condition that is increasing in prevalence. Currently, there are no evidence-based guidelines for managing ankle OA. One of the current challenges to establishing guidelines is the lack of a widely agreed-upon set of outcome measures that are consistently used in ankle OA research. Without a set of agreed-upon outcome measures, it is difficult to synthesise clinical trial outcomes through meta-analysis—an essential element of evidence-informed practice. In order to develop an appropriate set of outcome measures for ankle OA, it is important first to develop a core domain set. In this protocol, we describe the methodological approach that we will use to develop such a core domain set for ankle OA.MethodsWe established an international steering committee to guide the development of a core domain set for ankle OA. The core domain set development will follow a multi-staged approach consisting of three phases, involving participation by patients and clinicians/healthcare professionals. In phase 1, a list of candidate domains will be gleaned from (a) a scoping review of outcome measures used in ankle OA research, (b) qualitative interviews with individuals with ankle OA, and (c) qualitative interviews with healthcare professionals with expertise in ankle OA. In phase 2, the steering committee will review and generate a list of candidate domains from those gleaned in phase 1. In phase 3, this list of candidate domains will be considered in a Delphi process to reach a consensus on a core domain set. We anticipated this will involve 3 rounds of surveys.ConclusionThis protocol describes the methods that will be used to develop a core domain set of health-related aspects for ankle OA. Importantly, it will include both healthcare professional and patient involvement. This is a prerequisite step to developing a core outcome set for ankle OA that should be reported in all clinical trials for ankle OA. The findings will be widely disseminated across peer-refereed publication(s) and national and international conferences, as well as via relevant professional societies, patient support group organisations, and social media platforms.Project registrationThis project is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database on 17 March 2021. https://www.comet-initiative.org/Studies/Details/1837.

The 2021 Dutch Working Party on Antibiotic Policy (SWAB) guidelines for empirical antibacterial therapy of sepsis in adults

BackgroundThe Dutch Working Party on Antibiotic Policy (SWAB) in collaboration with relevant professional societies, has updated their evidence-based guidelines on empiric antibacterial therapy of sepsis in adults.MethodsOur multidisciplinary guideline committee generated ten population, intervention, comparison, and outcome (PICO) questions relevant for adult patients with sepsis. For each question, a literature search was performed to obtain the best available evidence and assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. The quality of evidence for clinically relevant outcomes was graded from high to very low. In structured consensus meetings, the committee formulated recommendations as strong or weak. When evidence could not be obtained, recommendations were provided based on expert opinion and experience (good practice statements).ResultsFifty-five recommendations on the antibacterial therapy of sepsis were generated. Recommendations on empiric antibacterial therapy choices were differentiated for sepsis according to the source of infection, the potential causative pathogen and its resistance pattern. One important revision was the distinction between low, increased and high risk of infection with Enterobacterales resistant to third generation cephalosporins (3GRC-E) to guide the choice of empirical therapy. Other new topics included empirical antibacterial therapy in patients with a reported penicillin allergy and the role of pharmacokinetics and pharmacodynamics to guide dosing in sepsis. We also established recommendations on timing and duration of antibacterial treatment.ConclusionsOur multidisciplinary committee formulated evidence-based recommendations for the empiric antibacterial therapy of adults with sepsis in The Netherlands.

Patients with lung disease caused by non-tuberculous mycobacteria in Germany: a trans-sectoral patient-oriented care concept

ZusammenfassungEinleitung Die heutige Versorgungssituation von Patienten mit einer durch nichttuberkulöse Mykobakterien verursachten Lungenerkrankung (NTM-LD) in Deutschland ist durch eine späte Diagnose, eine zumeist schlechte Prognose, vorzeitige Behandlungsabbrüche und hohe Folgekosten gekennzeichnet. V.a. bedingt durch eine erhöhte Anzahl von Krankenhausaufenthalten, sind die GKV-relevanten direkten Kosten (9.093,20 € Patient/Jahr) gegenüber typischen zugrundeliegenden Erkrankungen (z.B. Asthma: 706,00 € Patient/Jahr) erhöht. Ursachen einer Fehlversorgung sind eine unzureichende Differenzialdiagnostik, zumeist fehlende Überweiserstrukturen sowie eine eingeschränkte transsektorale Kommunikation aufgrund fehlender Vergütungsstrukturen. Die Befolgung von Behandlungsempfehlungen ist oft unzureichend und erschwert zusätzlich eine ausreichende, zweckmäßige und wirtschaftliche Versorgung. Methodik Zur Entwicklung des Versorgungskonzeptes wurden relevante Fachgesellschaften und Patientenorganisationen zur Versorgungssituation von NTM-LD befragt. Darauf folgend wurden 20 NTM-LD-Patienten, 5 niedergelassene Pneumologen und 8 Experten zur Ermittlung des derzeitigen Patientenweges in einem explorativen qualitativen Gespräch interviewt. Auf Grundlage der gewonnen Erkenntnisse wurde das vorliegende Versorgungskonzept durch die Autoren in einem Expertengremium entwickelt. Ergebnis Regionale Kompetenzzentren sollen Expertise bündeln und die Versorgungsqualität durch routinemäßige Konsultation und Einbeziehung in die Diagnose, Entscheidung der Behandlungsbedürftigkeit, Therapieeinleitung, Kontrolluntersuchungen und Feststellung des Therapieerfolges sowie durch eine adäquate Nachverfolgung der Patienten sicherstellen. Der überweisende Pneumologe wird weiterhin fallspezifisch die wohnortnahe Therapiebegleitung in einem präferierten Konzept der gemeinsamen Versorgung („shared-care“) übernehmen. Die Etablierung von klaren Überweiserstrukturen und Fallidentifikationskriterien helfen den niedergelassenen Leistungserbringern, Patienten unter Risiko frühzeitig in das Versorgungssystem einzubeziehen. Patienten und Pneumologen ohne spezielle NTM-Expertise müssen auf die Versorgungswege und die Schwere von NTM-LD sensibilisiert werden. Fazit Der erhöhten Morbidität und Mortalität von NTM-LD-Patienten muss mit einem patientenorientierten, interdisziplinären und transsektoralen Versorgungskonzept begegnet werden. Für ein bundesweites Pilotprojekt einer optimierten Versorgung von NTM-LD-Patienten wird daher ein Versorgungssystem mit klaren Überweiserstrukturen und Behandlungsabläufen vorgeschlagen

Regulatory Information and Guidance on Biosimilars and Their Use Across Europe: A Call for Strengthened One Voice Messaging.

BackgroundBeyond evaluation and approval, European and national regulators have a key role in providing reliable information on biosimilars and the science underpinning their development, approval, and use.ObjectivesThis study aims to (i) review biosimilar information and guidance provided by EMA and national medicines agencies and (ii) explore stakeholder perspectives on the role of regulators in enabling acceptance and use of biosimilars.MethodsThis study consists of (i) a comparative review of regulatory information and position statements across medicine agencies (n = 32) and (ii) qualitative interviews with stakeholders in Europe (n = 14).ResultsThe comparative analysis showed that regulatory information and guidance about biosimilars offered by national medicines agencies in Europe varies, and is limited or absent in multiple instances. Approximately 40% (13/31) of the national medicines agencies' websites did not offer any information regarding biosimilars, and for about half (15/31) no educational materials were provided. Only less than half of national medicines agencies provided guidance on biosimilar interchangeability and switching (8/31 and 12/31, respectively). Among the national medicines agencies that did offer guidance, the extent (e.g., elaborate position vs. brief statement) and content (e.g., full endorsement vs. more cautious) of the guidance differed substantially. Countries that have a strong involvement in EU level biosimilar regulatory activities generally had more elaborate information nationally. Interviewees underwrote the need for (national) regulators to intensify biosimilar stakeholder guidance, especially in terms of providing clear positions regarding biosimilar interchangeability and switching, which in turn can be disseminated by the relevant professional societies more locally.ConclusionThis study revealed that, despite strong EU-level regulatory biosimilar guidance, guidance about biosimilars, and their use differs considerably across Member States. This heterogeneity, together with the absence of a clear EU-wide position on interchangeability, may instill uncertainty among stakeholders about the appropriate use of biosimilars in practice. Regulators should strive for a clear and common EU scientific position on biosimilar interchangeability to bridge this gap and unambiguously inform policy makers, healthcare professionals, and patients. Furthermore, there is a clear opportunity to expand information at the national level, and leverage EU-developed information materials more actively in this regard.

S3 guideline Allergy Prevention.

S3 guideline Allergy Prevention.

Mental health during pregnancy and early childhood: recommendations from evidence-based guidelines

Abstract Background Mental health problems are common during pregnancy and after birth and are therefore often addressed in the context of antenatal and postnatal care. The project is an update of previous work and aimed at identifying and summarising screening and counselling recommendations from evidence-based guidelines. Mental health was defined broadly and included topics such as substance use and domestic violence. Methods Relevant guidelines were identified by searching 2 databases (G-I-N, TRIP Database) and websites of relevant institutions and professional societies. Guidelines, that were published or updated within the last 5 years and fulfilled methodological quality criteria, were included. Results A total of 52 guidelines from 16 different institutions fulfilled the inclusion criteria. The guidelines (predominantly) advocate the following mental health screenings: Interviewing about psychosocial stress factors and support needs during pregnancy and after birth; screening for postpartum depression and anxiety disorders; interviewing pregnant women about substance use (smoking, alcohol, drugs) and appropriate counselling. With regard to domestic violence and child welfare risks, some guidelines recommend routine screening and some recommend increased awareness of signs and symptoms by health workers. Routine screening for specific mental and behavioural disorders in children is not recommended by included guidelines; however, if there are indications and symptoms, clarification should take place and attention should be paid to signs and symptoms during preventive examinations. Conclusions The included guidelines recommend screening and/or counselling for the majority of the topics addressed. The results of the report can be used as a basis for decision-making for updating national antenatal care and screening programmes. Key messages The majority of the included evidence-based guidelines strongly recommend addressing mental health issues during pregnancy and after birth by offering screening and/or counselling. The recommendations from evidence-based guidelines can serve as a decision support for developing national antenatal and postnatal care programmes.