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Background Coronavirus disease (COVID‐19) is related to several extrapulmonary disorders; however, little is known about the clinical, laboratory, and histopathological characteristics of pernio‐like skin lesions associated with COVID‐19 infection. Objective To evaluate and summarize the clinical, laboratory, and histopathological characteristics of pernio‐like lesions reported in the literature. Methods We conducted a search of the PubMed, SciELO, and ScienceDirect databases for articles published between January 1, 2020 and November 30, 2020, following the PRISMA recommendations (PROSPERO registration ID: CRD42020225055). The target population was individuals with suspected or laboratory‐confirmed COVID‐19 with pernio‐like lesions. Observational studies, research letters, and case/series reports were all eligible for inclusion. Observational studies were evaluated using a random‐effects model to calculate the weighted mean prevalence, overall mean, and 95% confidence interval. We evaluated case studies using the chi‐square test for dichotomous variables and the Mann‐Whitney test for continuous variables. Results A total of 187 patients from case reports and 715 patients from 18 observational studies were included. The mean age of patients was 16.6 years (range 14.5‐18.8). Feet were affected in 91.4% (87.0‐94.4%) of patients in observational studies. The proportion of patients with a positive RT‐PCR test was less than 15%. Lesion topography and morphology were associated with age. Conclusion Lesions mostly occurred in pediatric patients, and the morphological characteristics tended to differ between pediatric and non‐pediatric populations. There is a possible multifactorial component in lesion pathophysiology. The non‐positivity of laboratory tests does not exclude an association with COVID‐19. Pernio‐like lesions may be a late manifestation of COVID‐19.

Objectives The food that people and animals consume leaves microscopic traces on teeth in predictable ways, and analyses of these markings-known as dental microwear analyses-allow us to reverse engineer the characteristics of diet. However, the microwear features of modern human diets are most often interpreted through the lens of ethnographic records. Given the subtle variation within human diets when compared to other species, we need better models of how foods and processing techniques produce marks on teeth. Here, we report on the second study to target the occlusal surface microwear of living human populations, and the first to target populations other than foragers. Methods We collected 150 dental impressions from five Kenyan communities: El Molo, Turkana (Kerio), Luhya (Webuye), Luhya (Port Victoria), and Luo (Port Victoria), representing a range of subsistence strategies and associated staple diets-fishing, pastoralism, and agriculture. Our results suggest that the occlusal microwear of these groups records differences in diet. However, biofilm obscured most of the molds obtained despite the steps taken to remove it, resulting in only 38 usable surfaces. Results Due to the biofilm problem and final sample size, the analysis did not have enough power to demonstrate the differences observed statistically. The results and problems encountered are here explained. Conclusions Considering that in vivo studies of dental microwear texture analysis have the potential to increase our understanding of the association between patterns of dental microwear and complex, mixed human diets, resolution of the current pitfalls of the technique is critical.

Summary Background and objectives Due to the development of new anti‐psoriatic drugs in combination with improved structures for implementation throughout Germany, the medical care of psoriasis patients has markedly improved. In this study we investigated the real‐life utilization of the health care system and identified reasons for dissatisfaction in affected individuals. Patients and methods This non‐interventional cross‐sectional study was conducted as an anonymous online survey from 12/2018 to 01/2019 in Germany. Participants with a self‐reported physician‐confirmed diagnosis of psoriasis and symptoms answered questions about their disease, its influence on daily life and their medical care. Results 649 participants with a mean age of 42.5 ± 13.7 years and equal gender distribution (male: 50.2 %) were evaluated. 54.1 % received medical treatment at the time of the study, 45.9 % did not. Among the participants with medical care, 59.3 % were only moderately or less satisfied with their treatment. Reasons for dissatisfaction with the medication included lack of efficacy and side effects. Participants without medical treatment specified a physician’s lack of time as a main reason for not seeking medical help. Conclusions Despite the availability of efficient therapeutic options in Germany, many individuals with psoriasis are not satisfied. This under‐treated group was identified as a new target population.

Despite efforts taken by the Government of India, still mothers and new-borns are excluded from the postnatal care services, especially during the critical first 24 h after delivery. Hence, we have done this study to find the determinants of postnatal care for mothers and new-borns in India. We have analysed the NFHS-4 data gathered from Demographic Health Survey programme. Stratification and clustering in the sample design was accounted using svyset command. Point estimates were reported as proportions with 95% Confidence Interval (CI). In total, 190,797 women who had at least one live birth were included. About 25.2% and 27.1% of the new-born received post-natal care within 24 and 48 h of delivery. The proportion of women who received post-natal care within 24 and 48 h after delivery was 63.4% and 65.2% respectively. Higher socioeconomic status, women living in Southern region, utilization of proper antenatal and intranatal care, and Caesarian mode of delivery had significantly higher postnatal care coverage among mothers and new-borns. This finding informs the policy makers regarding the status of postnatal care coverage, that can be incorporated to identify target populations for further strengthening of service delivery.

Human Papillomavirus (HPV) vaccines are safe and are highly effective in reducing the prevalence of HPV infections and subsequent HPV associated diseases in the target population. A systematic review and meta-analysis was carried out searching electronic databases for articles published between January 2007 and September 2020 reporting the prevalence estimates of vaccine HPV (vHPV) types in women who had received one or more doses of quadrivalent or bivalent vaccines. This systematic review was based on standard systematic review guidelines and the meta-analysis was performed by pooling the HPV vaccine type prevalence data with 95% confidence interval (CI) among 16,929 young women who had received the prophylactic HPV vaccines before the age of 27 years. The overall pooled prevalence of vHPV types was.0.04 (95% CI: 0.02, 0.05). The meta-analysis concludes that prophylactic HPV vaccination before the age of 27 years results in a decline of vHPV types in young women.

Screening for lung cancer (LC) by low-dose computed tomography (LDCT) has been demonstrated to reduce LC mortality in randomized clinical trials (RCTs), and its implementation is in preparation in many countries. However, definition of the target population, which was based on various combinations of age ranges and definitions of heavy smoking in the RCTs, is subject to ongoing debate. Using epidemiological data from Germany, we aimed to estimate prevalence of preclinical LC and positive predictive value (PPV) of LDCT in potential target populations defined by age and smoking history. Populations aged 50 to 69, 55 to 69, 50 to 74 and 55 to 79 years were considered in this analysis. Sex-specific prevalence of preclinical LC was estimated using LC incidence data within those age ranges and annual transition rates from preclinical to clinical LC obtained by meta-analysis. Prevalence of preclinical LC among heavy smokers (defined by various pack-year thresholds) within those age ranges was estimated by combining LC prevalence in the general population with proportions of heavy smokers and relative risks for LC among them derived from epidemiological studies. PPVs were calculated by combining these prevalences with sensitivity and specificity estimates of LDCT. Estimated prevalence of LC was 0.3% to 0.5% (men) and 0.2% to 0.3% (women) in the general population and 0.8% to 1.7% in target populations of heavy smokers. Estimates of PPV of LDCT were

GUIDELINE TITLE 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC) Expert Panel Working Group1 RELEASE DATE: Online: December 3, 2020 PRIOR VERSIONS: 1991, 1997, 2002, 2007 DEVELOPER: NAEPPCC Expert Panel Working Group (referred to as "the Expert Panel") of the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health FUNDING SOURCE: NHLBI of the National Institutes of Health TARGET POPULATION: Adults and children with asthma and recurrent wheezing.

With a sample of 125 adults under community supervision (71.20% male, 76.00% White, mean age = 33.17 years), this study evaluated need-to-service matching using an evaluation framework from implementation science. Need-to-service matching is a case management strategy intended to align service referrals in case plans with justice-involved persons' criminogenic needs. The results indicated that need-to-service matching reached a high percentage of its target population at 81.70%. Within criminogenic need areas, good match frequencies ranged from 80.00% in family/marital problems to 98.29% in alcohol/drug problems. Clinical staff also met the adherence benchmark applied by the current study, which required a 75.00% match between individuals' criminogenic needs and the services they received. Justice-involved persons had, on average, 90.46% of their criminogenic needs matched with at least one service referral. Over-prescription of services (i.e., recommendation of services that were not needed) was high, with frequencies in need areas ranging from 60.98% in education/employment to 82.21% in antisocial patterns. Methods from implementation science are useful for structuring evaluations of need-to-service matching, understanding implementation success and failure, and generating recommendations for improving implementation practice. The field would benefit greatly from benchmarks for need-to-service matching evaluation elements.

Randomised clinical trial (RCT) is the best study design to evaluate the effect of the treatment and preventive healthcare procedures. The effects of the tested treatments on patient's health are compared in terms of outcomes, which are used to evaluate the participants' health changes. However, these outcomes should be relevant for the target population. In that way, RCTs represent the type of primary study design that provides the most reliable evidence to implement therapies into the clinical practice. In this review, an outline of some aspects related to the choice of RCTs' outcomes was presented, focusing on the conduction of relevant trials in Paediatric Dentistry. The importance and necessity of defining a primary outcome were addressed, preferentially a clinically relevant endpoint. The patients should perceive this outcome, and changes in this variable should reflect directly patient's health improvement or impairment. Moreover, considerations about the objective or subjective variables, use of surrogate outcomes, and the increasing tendency to develop core outcome sets were also presented in this review. The main idea of this manuscript is the RCTs must evaluate outcomes relevant to the children's oral health in order to contribute to the implementation of treatments in the evidence-based health practice.

Aim This paper aims to study the correlation between religiosity and research misconduct in graduate nursing students and determine other factors that may have an impact on research misconduct in graduate nursing students. Design A cross‐sectional descriptive study was used to collect data from 49 graduate nursing students. Method The target population comprised all graduate nursing students enrolled at Jordan University of Science and Technology, Jordan. Participants who met the criteria were approached by the researcher and given a letter that provided detailed information about the study, and their informed consent was obtained. The questionnaire was consisted of three parts: a demographic datasheet, research misconduct tool and a religiosity questionnaire. Results The results demonstrated a significant interaction between perceptions about research misconduct and one of predictors such as religiosity, where higher religiosity was associated with perceiving research misconduct as a critical issue.

Cardiovascular diseases constitute one of the main aetiologies of mortality among patients with cancer. Population ageing and cancer survival rate improvements have resulted in the coexistence of cardiovascular diseases and malignancies in an increasing number of patients. With the diversity in treatments and the introduction of new drug lines, multiple mechanisms of cardiovascular injury have been recognized in these patients. Cardio‐oncology is an emerging entity introduced to provide a proper solution to the several challenges encountered in the management of patients with cancer and cardiac involvement. This review will assess the logical grounds for establishing a cardio‐oncology unit, describe the main objectives and the detailed responsibilities in such systems, and outline the target population. Furthermore, the importance of research and appropriate data collection will be highlighted. Lastly, the special considerations and modifications required for setting up such centres in the developing countries are discussed.

Background The purpose of this article is to investigate the link between women's autonomy and their utilization of antenatal, natal and post-natal healthcare services in Tajikistan. Previous studies focused only on a single dimension of such services, for instance, utilization of antenatal care. By contrast, we explore antenatal, natal and post-natal healthcare services utilization using the number of indicator for each of the dimensions. Methods Data come from two national surveys that were conducted in 2012 and 2017. The target population is women of reproductive age (16-49) who were married or cohabitating with a partner (N = 7540). Several regression models were estimated to quantify association between women's autonomy and the utilization. Results Lack of women's autonomy is associated with a lower probability of: (a) having had at least four antenatal check-ups during pregnancy, (b) beginning first antenatal check-up early, (c) delivering in a healthcare facility, (d) having the skilled attendance during pregnancy, (e) having a mother post-delivery check-up, and (f) having a child post-delivery check-up. The size effect of women's autonomy is stronger than that of well-developed precursors of utilization such as poverty and mothers' education. Conclusion Women autonomy should be improved to achieve higher rates of child and maternal healthcare utilization. Studies of maternal and child healthcare utilization should control explicitly for women's autonomy.

One of the challenges in the design of confirmatory trials is to deal with uncertainties regarding the optimal target population for a novel drug. Adaptive enrichment designs (AED) which allow for a data-driven selection of one or more pre-specified biomarker subpopulations at an interim analysis have been proposed in this setting but practical case studies of AEDs are still relatively rare. We present the design of an AED with a binary endpoint in the highly dynamic setting of cancer immunotherapy. The trial was initiated as a conventional trial in early triple-negative breast cancer but amended to an AED based on emerging data external to the trial suggesting that PD-L1 status could be a predictive biomarker. Operating characteristics are discussed including the concept of a minimal detectable difference, that is, the smallest observed treatment effect that would lead to a statistically significant result in at least one of the target populations at the interim or the final analysis, respectively, in the setting of AED., 10 pages, 1 figures

BACKGROUND: Excess days in acute care (EDAC) after total joint arthroplasty (TJA) represent a large economic burden. We developed an Orthopedic EDAC program that triages TJA patients to the appropriate service line (orthopedic vs medicine) and level of care (observation vs inpatient) on re-presentation. We developed and used evidence-based protocols for the treatment of TJA patients who are rehospitalized. METHODS: We defined Orthopedic EDAC as the length of stay (LOS) during readmission and observation stays. Our target population included TJA and revision TJA patients. Patients between April 2016 and September 2017 and between October 2017 and September 2018 were defined as pre-implementation and postimplementation of the Orthopedic EDAC program, respectively. RESULTS: A total of 2,662 patients underwent TJA and revision TJA during the pre-implementation and postimplementation periods. Twenty-three patients were managed on observation status during the study period. Readmissions decreased from 49 (6.1%) during preimplementation to 37 (2.0%) during post-implementation (P = .004). By design, more rehospitalized patients were on the orthopedic surgery service after implementation of the Orthopedic EDAC program (n = 49; 70%) versus before (n = 22; 35%; P = .028). EDAC LOS decreased from 7.75 days to 4.73 days (P = .005). CONCLUSION: In this single-center, before-after pilot of a novel Orthopedic EDAC program, we demonstrated a reduction in readmissions and Orthopedic EDAC LOS, as well as improved continuity of care for TJA patients on representation. Journal of Hospital Medicine 2020;15:XXXXXX. © 2020 Society of Hospital Medicine

Background Blood flow restriction exercise has increasingly broad applications among healthy and clinical populations. Ensuring the technique is applied in a safe, controlled, and beneficial way for target populations is essential. Individualized cuff pressures are a favored method for achieving this. However, there remains marked inconsistency in how individualized cuff pressures are applied. Objectives To quantify the cuff pressures used in the broader blood flow restriction exercise literature, and determine whether there is clear justification for the choice of pressure prescribed. Methods Studies were included in this review from database searches if they employed an experimental design using original data, involved either acute or chronic exercise using blood flow restriction, and they assessed limb or arterial occlusion pressure to determine an individualized cuff pressure. Methodologies of the studies were evaluated using a bespoke quality assessment tool. Results Fifty-one studies met the inclusion criteria. Individualized cuff pressures ranged from 30% to 100% arterial occlusion pressure. Only 7 out of 52 studies attempted to justify the individualized cuff pressure applied during exercise. The mean quality rating for all studies was 11.1 ± 1.2 out of 13. Conclusions The broader blood flow restriction exercise literature uses markedly heterogeneous prescription variables despite using individualized cuff pressures. This is problematic in the absence of any clear justification for the individualized cuff pressures selected. Systematically measuring and reporting all relevant acute responses and training adaptations to the full spectrum of BFR pressures alongside increased clarity around the methodology used during blood flow restriction exercise is paramount.

Beans are noted for their beneficial effects on blood glucose for persons with type 2 diabetes mellitus (T2DM). However, little is known about dietitian attitudes and perceptions, self‐efficacy, or counseling practices about beans in T2DM management. Through an online survey, the attitudes and perceptions dietitians have toward the role of beans in managing T2DM were examined. The practice intentions for advising T2DM clients about beans, perceived self‐efficacy for counseling on general nutrition topics and specifically on beans, were evaluated. While the target population was dietitians, all persons on the Arizona Dietetic Association and the Arizona School Nutrition Association listservs received a direct email invitation for an online survey on foods and chronic disease. There was no mention of beans or pulses to reduce bias toward bean advocates. Of the 302 dietitian respondents, over 66% counseled clients with T2DM. Fewer clinical counseling dietitians recommended beans to control blood glucose (p = .041) or to increase fiber (p, Scientific evidence supports that eating beans is helpful in managing type 2 diabetes with adults. This study investigated Registered Dietitians' (RDs) views on beans and if they recommended to persons with type 2 diabetes. Findings suggest that RDs who do not counsel for diabetes in clinical settings are more likely to recommend them to clients.

Clinical studies, especially randomized, controlled trials, are essential for generating evidence for clinical practice. However, generalizability is a long‐standing concern when applying trial results to real‐world patients. Generalizability assessment is thus important, nevertheless, not consistently practiced. We performed a systematic review to understand the practice of generalizability assessment. We identified 187 relevant articles and systematically organized these studies in a taxonomy with three dimensions: (i) data availability (i.e., before or after trial (a priori vs. a posteriori generalizability)); (ii) result outputs (i.e., score vs. nonscore); and (iii) populations of interest. We further reported disease areas, underrepresented subgroups, and types of data used to profile target populations. We observed an increasing trend of generalizability assessments, but

Comparable performance indicators for breast cancer screening in the European Union (EU) have not been previously reported. We estimated adjusted breast cancer screening positivity rate (PR) and detection rates (DR) to investigate variation across EU countries. For the age 50-69 years, the adjusted EU-pooled PR for initial screening was 8.9% (cross-programme variation range 3.2-19.5%) while DR of invasive cancers was 5.3/1,000 (range 3.8-7.4/1,000) and DR of ductal carcinoma in situ (DCIS) was 1.3/1,000 (range 0.7-2.7/1,000). For subsequent screening, the adjusted EU-pooled PR was 3.6% (range 1.4-8.4%), the DR was 4.0/1,000 (range 2.2-5.8/1,000) and 0.8/1,000 (range 0.5-1.3/1,000) for invasive and DCIS, respectively. Adjusted performance indicators showed remarkable heterogeneity, likely due to different background breast cancer risk and awareness between target populations, and also different screening protocols and organisation. Periodic reporting of the screening indicators permits comparison and evaluation of the screening activities between and within countries aiming to improve the quality and the outcomes of screening programmes. Cancer Screening Registries would be a milestone in this direction and EU Screening Reports provide a fundamental contribution to building them.

Wolbachia are maternally inherited endosymbiotic bacteria found within many insect species. Aedes mosquitoes experimentally infected with Wolbachia are being released into the field for Aedes‐borne disease control. These Wolbachia infections induce cytoplasmic incompatibility which is used to suppress populations through incompatible matings or replace populations through the reproductive advantage provided by this mechanism. However, the presence of naturally occurring Wolbachia in target populations could interfere with both population replacement and suppression programs depending on the compatibility patterns between strains. Aedes aegypti were thought to not harbor Wolbachia naturally but several recent studies have detected Wolbachia in natural populations of this mosquito. We therefore review the evidence for natural Wolbachia infections in A. aegypti to date and discuss limitations of these studies. We draw on research from other mosquito species to outline the potential implications of natural Wolbachia infections in A. aegypti for disease control. To validate previous reports, we obtained a laboratory population of A. aegypti from New Mexico, USA, that harbors a natural Wolbachia infection, and we conducted field surveys in Kuala Lumpur, Malaysia, where a natural Wolbachia infection has also been reported. However, we were unable to detect Wolbachia in both the laboratory and field populations. Because the presence of naturally occurring Wolbachia in A. aegypti could have profound implications for Wolbachia‐based disease control programs, it is important to continue to accurately assess the Wolbachia status of target Aedes populations., We review the evidence for natural Wolbachia infections in Aedes aegypti mosquitoes and attempt to validate previous previous reports through screening of laboratory and field populations. We detected no Wolbachia infection and therefore discuss the limitations of current studies and describe the evidence needed by future studies.

This report is part of the Echinococcus multilocularis surveillance scientific reports which are presented annually by EFSA to the European Commission and are intended to assess the sampling strategy, data collection and detection methods used by Finland, Ireland, United Kingdom (Northern Ireland) and Norway in their respective surveillance programmes. The surveillance programmes of these four countries were evaluated by checking the information submitted by each of them and verifying that the technical requirements were fulfilled as laid down in Commission Delegated Regulation (EU) 2018/772 of 21 November 2017 supplementing Regulation (EU) No 576/2013 of the European Parliament and of the Council with regard to preventive health measures for the control of Echinococcus multilocularis infection in dogs, and repealing Delegated Regulation (EU) No 1152/2011. The information was divided in four different categories for assessment: the type and sensitivity of the detection method, the selection of the target population, the sampling strategy and the methodology. For each category, the main aspects that need to be considered in order to accomplish the technical requirements of the legislation were checked against compliance of several criteria. Three of the countries participating in this surveillance (Finland, Ireland and Norway (mainland)) succeeded in the fulfilment of the technical legal requirements foreseen in Commission Delegated Regulation (EU) 2018/772 concerning these four different categories. Northern Ireland did not fulfil those requirements, not even assuming a diagnostic test sensitivity value of 0.99 (value provided by the national reference laboratory, higher than the conservative sensitivity value suggested by EFSA, i.e. 0.78). None of the four countries recorded positive samples in the 12‐month reporting period.

GUIDELINE TITLE: Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: A revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists RELEASE DATE: Online: March 19, 2020 PRIOR VERSION: 2009 DEVELOPERS: American Society of Health-System Pharmacists (ASHP), the Infectious Diseases Society of America (IDSA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP) FUNDING SOURCE: ASHP, IDSA, PIDS, SIDP TARGET POPULATION: Adults, children, and neonates treated for documented or presumed methicillin-resistant Staphylococcus aureus infection

Serological testing is increasingly recognized as a useful tool for management of the COVID‐19 pandemic.1 Cross‐sectional serosurveys provide information on exposure levels in a target population, which is helpful for designing public health strategies to blunt community transmission.2 This article is protected by copyright. All rights reserved.

The Virtual Population (ViP) phantoms have been used in many dosimetry studies, yet, to date, anatomical phantom uncertainty in radiofrequency (RF) research has largely been neglected. The objective of this study is to gain insight, for the first time, regarding the uncertainty in RF-induced fields during magnetic resonance imaging associated with tissue assignment and segmentation quality and consistency in anatomical phantoms by evaluating the differences between two generations of ViP phantoms, ViP1.x and ViP3.0. The RF-induced 10g-average electric (E-) fields, tangential E-fields distribution along active implantable medical devices (AIMD) routings, and estimated AIMD heating were compared for five phantoms that are part of both ViP1.x and ViP3.0. The results demonstrated that differences exceeded 3 dB (-29%, +41%) for local quantities and 1 dB (±12% for field, ±25% for power) for integrated and volume-averaged quantities (e.g., estimated AIMD-heating and 10 g-average E-fields), while the variation across different ViP phantoms of the same generation can exceed 10 dB (-68% and +217% for field, -90% and +900% for power). In conclusion, the anatomical phantom uncertainty associated with tissue assignment and segmentation quality/consistency is larger than previously assumed, i.e., 0.6 dB or ±15% (k = 1) for AIMD heating. Further, multiple phantoms based on different volunteers covering the target population are required for quantitative analysis of dosimetric endpoints, e.g., AIMD heating, which depend on patient anatomy. Phantoms with the highest fidelity in tissue assignment and segmentation should be used, as these ensure the lowest uncertainty and possible underestimation of exposure. To verify that the uncertainty decreases monotonically with improved phantom quality, the evaluation of differences between phantom generations should be repeated for any improvement in segmentation. Bioelectromagnetics. 2019;40:458-471. © 2019 Bioelectromagnetics Society.

Recent International Conference on Harmonization (ICH) guidelines provide pharmaceutical companies with regulatory justifications to pursue various global drug‐development pathways, in some of which “local” dose‐ranging and/or pivotal phase III studies are skipped. We examined the association between the clinical development pathway and postmarketing safety in Japan for 177 new molecular entities approved between 2004 and 2013 focusing on dose setting histories for each drug. The risk of drug‐related deaths was higher when companies did not conduct local (i.e., Japanese) dose‐ranging studies and/or pivotal studies. Even when local dose‐ranging studies were conducted, the risk remained higher in some drugs for which the approved dose in Japan was set equal to that in the United States. Drugs developed under a bridging strategy tended to show lower risks. These results suggested that local clinical studies may play a substantial role in achieving optimization of postmarketing drug use in each local target population.

Nonhuman animal research and phase I healthy-volunteer clinical trials are both critical components of testing the safety of investigational drugs as part of the development of new pharmaceuticals. In addition, these types of research share important structural features, as both take place in confinement and both use subjects that are dissimilar to the target population. By mobilizing a model-organism framework for phase I trials, we employ concepts and mechanisms typical to animal research to query gaps in the human subjects ethics and policy framework. By bringing these two research worlds together, we aim to illustrate how the model-organism framework can enhance healthy volunteers’ welfare during trials, improve research oversight, and more critically assess the science value of current phase I trials.

Self‐medication can facilitate patients’ access to medicinal products, save time, and reduce financial and health‐care service use burden. On the other hand, irresponsible use of self‐medications can result in adverse consequences. Self‐medication is common among different demographic groups including pregnant women. In general, medicinal products might have harmful effects on mothers and baby. This study aimed to assess self‐medication practices among pregnant women in the northern region of Jordan. A cross‐sectional study was conducted on pregnant women attending outpatient clinics in the northern region of Jordan. Self‐medication practices among the target population were assessed using a survey questionnaire that was administered through interviewer‐assisted mode. Data were collected between December 2019 and September 2020, and descriptive statistics and inferential analysis were applied. A total of 1,313 pregnant women were surveyed (response rate = 95.50%). Self‐medication and the use of herbal remedies were practiced by 33.10% and 32.14% of the participant, respectively. Headaches and general pains were the most frequently reported conditions treated by self‐medication practice with either conventional medicinal products or herbal remedies. The gravidity (≥4) and the gestational stage (≥28 weeks) were the predictors of self‐medication practice. This study showed that self‐medication was not widely practiced by pregnant women in the northern region of Jordan. Disease simplicity and previous history were the main motives for self‐medicating. Efforts should be made by health‐care providers to address pregnant women and educate them to increase their awareness about the unsafe use of medicines and the harmful effects on fetus., A cross‐sectional study conducted at the Northern region of Jordan showed that 33.1% of pregnant women practiced self‐medication during their pregnancy. Health‐care providers need to be actively involved in educating pregnant women and raising their awareness about the safe utilization of medicines during pregnancy.

GUIDELINE TITLE: American Society of Hematology 2020 Guidelines for Sickle Cell Disease: Management of Acute and Chronic Pain RELEASE DATE: June 19, 2020 PRIOR VERSION: Not applicable DEVELOPER: American Society of Hematology Guideline Panel on Sickle Cell Disease-Related Pain FUNDING SOURCE: American Society of Hematology TARGET POPULATION: Adult and pediatric patients with a history of sickle cell disease with acute and chronic pain.

GUIDELINE TITLE American College of Gastroenterology: Upper Gastrointestinal and Ulcer Bleeding RELEASE DATE: May 1, 2021 PRIOR VERSION(S): March 1, 2012 DEVELOPER: American College of Gastroenterology Practice Parameters Committee FUNDING SOURCE: American College of Gastroenterology TARGET POPULATION: Adult patients with overt upper gastrointestinal bleeding.

Compared with drugs from the blockbuster era, recently authorized drugs and those expected in the future present a heterogenous mix of chemicals, biologicals, and cell and gene therapies, a sizable fraction being for rare diseases, and even individualized treatments or individualized combinations. The shift in the nature of products entails secular trends for the definitions of "drugs" and "target population" and for clinical use and evidence generation. We discuss that the lessons learned from evidence generation for 20th century medicines may have limited relevance for 21st century medicines. We explain why the future is not about randomized controlled trials (RCTs) vs. real-world evidence (RWE) but RCTs and RWE-not just for the assessment of safety but also of effectiveness. Finally, we highlight that, in the era of precision medicine, we may not be able to reliably describe some small treatment effects-either by way of RCTs or RWE.

Objectives Multiple regression approaches for estimating body mass by somatometry typically use stature and biiliocristal breadth. However, these measures were obtained largely from Europeans, Africans, and Indo-Mediterraneans, whereas mid-latitude Asians were not broadly reflected. Thus, new estimation formulas for circum-Pacific Asians were devised, and the accuracy was evaluated using raw individual data. Materials and methods Targeting Asians in the traditional society or before the 1960s and performing multiple regression analysis (MRA) with body weight as the objective variable, and stature, body breadth, and product of head length/breadth (HLBpr) as explanatory variables. The target population was divided into four climate groups, and the formulas were prepared for each sex or the combined-sexes. Results The MRA by stature and body breadth indicated significant multiple correlation coefficients (R) in many formulas. R was higher in the combined-sexes. Among the four climate groups, the temperate group showed the highest R. In the East/Southeast Asians, R exceeded 0.8 in the MRA by stature and HLBpr. Substituting the raw data of 19th-century Japanese males, the temperate group formulas presented the least error, and the error in all the formulas using body breadth was Conclusions As body mass index varies significantly depending on some climatic factors, estimation formulas mixed with various climate groups are not desirable because of the large errors. For the mid-latitude Asians, the temperate group formulas are expected to have a smaller error; however, in the group where the proportion of underweight individuals was originally high, any formula tends to be overestimated.

Aims The aims of this work were to translate, culturally adapt and evaluate the reliability and validity of the Chinese version of the Self-Management and Transition to Adulthood with Rx = Treatment Questionnaire. Background Children and young people with chronic diseases are expected to start self-managing their diseases and have a smooth and coordinated transition from paediatric- to adult-oriented care. Design This study involved the cultural adaptation of a questionnaire into Chinese and examined its factor structure. Methods This was a multicentre cross-sectional study of children and young people/adolescents (8-18 years) who were diagnosed with chronic diseases in China from June 2016 to December 2018. Exploratory and confirmatory factor analyses were performed to analyse the questionnaire's validity. Results Four major factors were identified in the Chinese version of the questionnaire, and it had a good fit to the target population. The internal reliability was good. All factors were positively and strongly correlated with the total score. The t test revealed that the Medication Management score was not significantly different between two age groups (8-11 and 12-18 years), but the scores of the other factors and overall scale were lower in the 8-11 years age group. Conclusion The Chinese version of the questionnaire has good reliability and validity in the Chinese context.

At the request of the European Commission, EFSA prepared the general guidelines for surveys of plant pests, describing the legal, international and scientific context in which the surveys are designed, the basic principles implemented for surveillance of quarantine pests and introducing the concepts needed for the design of statistically sound and risk-based surveys. Three types of specific surveys are addressed: detection surveys for substantiation of pest freedom, delimiting surveys for determining the boundaries of an infested zone, and monitoring surveys for prevalence estimation when measuring the progress of eradication measures or for confirming a low pest prevalence area. For each survey, the survey parameters are introduced and their interactions analysed showing the importance of the assumptions that are taken for each one of them: (i) the aims of the survey are defined as the confidence of detecting a given pest prevalence (design prevalence), this reflects the trade-off between the acceptable level of the risk and availability of resources that determine the strength of the evidence to support the conclusion of the survey; (ii) the target population is addressed in terms of its structure and size, including the risk factors; and (iii) the method sensitivity is defined as the combination of the sampling effectiveness and the diagnostic sensitivity. EFSA’s RiBESS+ tool is introduced for calculating the sample size using the survey parameters as input values for a statistically sound and risk-based survey design. The mathematical principles behind the tool are in line with the International Standards for Phytosanitary Measures. The survey design is flexible and can be tailored to each pest and specific situation in the Member States. Once the survey is implemented following this approach, the conclusions allow surveys to be compared across time and space, contributing to the harmonisation of surveillance activities across the EU Member States.

From the mid-20th century, accumulating evidence has supported the introduction of screening for cancers of the cervix, breast, colon and rectum, prostate (via shared decisions), and lung. The opportunity to detect and treat precursor lesions and invasive disease at a more favorable stage has contributed substantially to reduced incidence, morbidity, and mortality. However, as new discoveries portend advancements in technology and risk-based screening, we fail to fulfill the greatest potential of the existing technology, in terms of both full access among the target population and the delivery of state-of-the art care at each crucial step in the cascade of events that characterize successful cancer screening. There also is insufficient commitment to invest in the development of new technologies, incentivize the development of new ideas, and rapidly evaluate promising new technology. In this report, the authors summarize the status of cancer screening and propose a blueprint for the nation to further advance the contribution of screening to cancer control.

Aims Presentations of intoxicated patients to hospital are frequent and increasing. We aimed to review the existing evidence that the presence of inpatient clinical toxicology services reduces use of resources without impacting on the care of these patients. Methods We conducted a literature search using the Cochrane Library, PubMed, and Embase for articles that measured length of stay (and other outcomes) for the target population, with toxicology services as an intervention. The articles were reviewed with respect to the ROBINS-I tool. Results Seven relevant articles were identified. Six of these studies demonstrated reduced hospital length of stay for intoxicated patients in hospitals with inpatient toxicology services. None of the articles demonstrated a detriment in morbidity or mortality. There were also improvements in other resource-related outcomes. Conclusions The presence of inpatient toxicology services appears to improve resource utilization, in reduction of length of stay, as well as a number of other related outcomes. It does this without compromising on patient morbidity or mortality. Thus, it should be considered as a potential model of care for future toxicology services, especially with current trends of increasing demand for service efficiency.

This paper investigates the landscape of state‐level adaptation planning in the United States. We answer three primary research questions: First, how are states planning for climate change? Second, who are states targeting for climate adaptation? Third, what tools are states using to motivate climate adaptation efforts? We develop and implement a coding scheme using Schneider and Ingram’s Social Construction Framework (SCF) to characterize variation in 2033 individual adaptation goals mentioned in all 14 American states with explicit adaptation plans. We use these data to understand the types of tools used to motivate different actors (governmental, private, nonprofit) to adapt to climate change. We find that the most frequent target of state adaptation planning is the state itself, which provides an opportunity to extend the SCF to a target group often not mentioned in public policy. Specifically, we find that states target themselves with mandates or tools designed to acquire information. Other stakeholders in adaptation are more likely to be the targets of capacity building tools. Private actors are the only population more likely to be targeted by incentives. The project expands the Social Construction Framework to include targets and tools of planning efforts. Practically, our article offers a methodology by which to compare the vastly heterogeneous efforts to adapt to climate change at the subnational level. 本文考查了美国各州的气候适应计划。作者回答了三个主要研究问题：第一，各州如何制定气候变化方面的计划？第二，各州针对气候适应的目标对象是谁？第三，各州使用何种工具来激励气候适应相关工作？通过使用施耐德和英格兰姆的社会建构框架（Social Construction Framework，SCF），作者提出并实施了一项编码方案，用于描述14个具备明确适应计划的美国州在2033个适应目标之间存在的变化。作者使用这些数据以理解在激励不同行动者（来自政府、私人或非营利组织）适应气候变化时应用的工具类型。作者发现，州适应计划最常将各州本身作为目标，因为后者提供机会将SCF带给在公共政策中较少提到的目标群体。具体而言，作者发现，各州用指令或工具（用于获取信息）将自身设为目标。适应计划中的其他利益相关者更可能成为能力建设工具的目标。私人行动者是唯一更可能被激励手段设为目标的群体。本文将社会建构框架扩大，它包括了气候适应计划相关工作的目标和应用的工具。实际上，本文提供了一种方法论，通过此方法论可以比较各区域在适应气候变化上所做的极其不同的努力。 Este documento investiga el panorama de la planeacion a la adaptacion a nivel estatal en los Estados Unidos. Respondemos tres interrogantes primordiales de investigacion: Primero, ?como estan planificando los estados para el cambio climatico? Segundo, ?que poblaciones son el objetivo de la adaptacion al clima? Tercero, ?que herramientas estan usando los estados para motivar a los esfuerzos de adaptacion al clima? Desarrollamos e implementamos un esquema de codificacion al utilizar el Marco Teorico de la Construccion Social de Schneider e Ingram (SCF) para caracterizar la variacion en 2033 objetivos individuales de adaptacion mencionados en todos los 14 estados de EE. UU. que tienen planes de adaptacion especificos. Utilizamos estos datos para comprender los tipos de herramientas que se usan para motivar a los diferentes actores (gubernamental, privado, sin fin de lucro) para la adaptacion al cambio climatico. Hallamos que el objetivo mas frecuente de la planeacion estatal para la adaptacion es el estado en si, lo cual proporciona una oportunidad para extender el SCF a un grupo destinario que no es mencionado publicamente con frecuencia. Especificamente, hallamos que los estados se ponen como objetivo a si mismos mediante el uso de mandatos o herramientas designadas para la adquisicion de informacion. Otros afectados de la adaptacion son mas propensos a ser objetivos de herramientas de construccion de capacidad. Los actores privados son la unica poblacion que es mas propensa a ser objetivo de los incentivos. El proyecto expande el Marco Teorico de la Construccion Social para incluir objetivos y herramientas de los esfuerzos de planeacion. Practicamente, nuestro articulo ofrece una metodologia mediante la cual se pueden comparar los esfuerzos mayormente heterogeneos para adaptarse al cambio climatico a nivel subnacional.

Background Data on the prevalence and disease management of chronic urticaria (CU) and chronic spontaneous urticaria (CSU) in the pediatric population are scarce. This study assessed the prevalence of CU and CSU, and disease management among pediatric patients (0-17 years). Methods A physician-based online survey was conducted in 5 European countries (United Kingdom, Germany, Italy, France, and Spain) assessing the annual diagnosed prevalence, disease characteristics, and treatment patterns in the target population. Results are based on physician responses and analyzed using descriptive statistics. Prevalence estimates were calculated based on the number of CU/CSU pediatric patients diagnosed, seen, and treated by the respondents and extrapolated to the total pediatric population from each country. Results Across 5 European countries, the one-year diagnosed prevalence of CU and CSU in pediatric patients was 1.38% (95% CI, 0.94-1.86) and 0.75% (95% CI, 0.44-1.08), respectively. Angioedema was reported in 6%-14% of patients. A large proportion of CSU pediatric patients (40%-60%) were treated with H1-antihistamines at approved dose and 16%-51% received H1-antihistamines at higher doses. Approximately 1/3 of pediatric CSU patients remained uncontrolled with H1-antihistamines at approved/higher doses. Other prescribed treatments were oral corticosteroids (10%-28%) and topical creams (15%-26%). Conclusions This study revealed a prevalence of CSU among pediatric population comparable to adults and also suggested an unmet need for approved treatments for inadequately controlled pediatric CSU patients. It is truly of concern that harmful (oral steroids) or insufficient (topical creams) treatments were frequently used despite better and guideline-recommended alternatives.

Fungal infection in cystic fibrosis (CF) is a recognized challenge, with many areas requiring further investigation. Consensus definitions exist for allergic bronchopulmonary aspergillus in CF, but the full scope of clinically relevant non-allergic fungal disease in CF-asymptomatic colonization, transient or chronic infection localized to endobronchial mucus plugs or airway tissue, and invasive disease-is yet to be clearly defined. Recent advances in mycological culture and non-culture identification have expanded the list of both potential pathogens and community commensals in the lower respiratory tract. Here we aim to outline the current understanding of fungal presence in the CF respiratory tract, risk factors for acquiring fungi, host-pathogen interactions that influence the role of fungi from bystander to pathogen, advances in the diagnostic approaches to isolating and identifying fungi in CF respiratory samples, challenges of classifying clinical phenotypes of CF patients with fungi, and current treatment approaches. Development and validation of biomarkers characteristic of different fungal clinical phenotypes, and controlled trials of antifungal agents in well-characterized target populations, remain central challenges to surmount and goals to be achieved.

AimsThe Think Tank aimed to discuss the pitfalls and advantages of current definitions in terms of research and management of underactive bladder (UAB). UAB broadly defines a symptom complex of bladder emptying problems and does not indicate a specific pathology. Detrusor underactivity (DU) is a urodynamic diagnosis from pressure-flow studies. The correlation of UAB with DU remains to be precisely determined. MethodsThe presentations and subsequent discussion, leading to research recommendations during the Think Tank of the International Consultation on Incontinence Research Society in Bristol, 2017, are summarized. ResultsTo develop more specific individualized management strategies, the Think Tank panel proposed (i) that, since defining a single type of index patient to represent all UAB will not fulfill all clinical research needs, several index patients should be defined by phenotyping of patients with UAB, including, children, young men and women, elderly male and female patients with co-existing DU and detrusor overactivity, and neurological patients with UAB; (ii) prospective longitudinal studies to assess the natural history of UAB, in the different target populations, based on different UAB phenotypes, should be initiated; (iii) DU should be precisely defined by urodynamic parameters; and (iv) work to develop validated specific questionnaires combined with non-invasive tests for screening, diagnosis and follow up, needs to be continued. ConclusionsThe precise relationship of UAB to DU remains to be defined. Phenotyping patients with UAB/DU, performing prospective trials of natural history, and developing symptom questionnaires and diagnostic investigations will improve our ability to identify and treat UAB/DU.

BACKGROUND: Cognitive behavioural therapy (CBT) is commonly used to treat cancer patients with psychological disorders such as depression. There has been little qualitative research exploring the experience of therapists delivering CBT to patients with advanced cancer and long-term health conditions generally. Therapists' views may help identify difficulties in delivering therapy and how these may be overcome. The aim of this study was to inform practice by qualitatively exploring the experiences of therapists delivering CBT to patients with advanced cancer. DESIGN: Sixteen semi-structured interviews were conducted with therapists from Increasing Access to Psychological Therapy (IAPT) services in London, UK, who had delivered CBT to patients enrolled on the CanTalk trial. Interviews were recorded, transcribed, and analysed using framework analysis. RESULTS: Therapists reported positive experiences when working with the target population. Flexibility, adaptability, and a consideration of individual needs were identified as important when delivering CBT, but the rigidity of IAPT policies and demand for services were perceived as problematic. Although therapists reported adequate training, specialist supervision was desired when delivering therapy to this complex population. CONCLUSION: IAPT therapists can deliver CBT to advanced cancer patients, given therapists positive experiences evident in the present study. However, it was concluded that additional service and modifications of therapy may be needed before positive outcomes for both therapists and patients can be achieved.

Context Although the subjective trauma exposure criterion was removed from the DSM-5 criteria set for posttraumatic stress disorder (PTSD), emerging literature suggests that peritraumatic distress may be useful in predicting outcomes after exposure to a stressful event. Method We conducted a comprehensive review of the literature examining the association between peritraumatic distress and PTSD and other psychiatric outcomes. The 57 studies herein varied in both experimental design and target populations. Results Forty-eight studies found associations between peritraumatic distress and PTSD outcome measures, 23 found associations between peritraumatic distress and other psychiatric outcomes, and three found associations between peritraumatic distress and PTSD-related symptoms or other psychiatric outcomes after non-Criterion A stressful events by DSM-5 criteria. Conclusion Peritraumatic distress is associated with PTSD symptom severity, other psychiatric symptoms, and severity of PTSD-related symptoms after exposure to non-Criterion A events, suggesting that peritraumatic distress is a risk factor for various psychiatric outcomes and furthering our understanding of the impact of subjective experience on trauma psychopathology.

International audience; Background - In occupational epidemiology, a male-centered perspective often predominates. We aimed to describe current research practices in terms of gender consideration at different stages of epidemiological studies. Methods - A systematic review of occupational lung cancer publications indexed in PubMed was conducted over the period 2003-2014. Articles were described according to the sex composition of their study sample. Results - In 243 studies, 7 (3%) were women-only, 101 (41%) were mixed, with a disproportionate men-to-women ratio (P50 = 3.5; P75 = 12.4). A shift was observed from mixed and unspecified source populations to men-only final samples. Our results also suggest implicit generalization of results from men-only studies, a lack of tests of interaction and often unjustified sex-adjustment for mixed studies. Conclusions - The lower proportion of women in studies cannot be fully explained by their under-representation in the target populations, since there were large numbers of women among both potentially exposed workers and patients diagnosed with lung cancer.

OBJECTIVES 'Get an early check - chrysanthemum tea' was a multimedia campaign promoting HIV testing targeting Chinese-speaking men who have sex with men (MSM) in Hong Kong, China. It ran from October to December 2015. This study was carried out to investigate the level of campaign exposure among Chinese-speaking MSM in Hong Kong and the association between uptake of HIV testing in the last 6 months and campaign exposure. METHODS A cross-sectional survey was conducted 6 months after the campaign was launched. Participants were Hong Kong Chinese-speaking men aged ≥18 years who had had anal or oral sex with at least one man in their lifetime. A total of 153 eligible participants completed the anonymous self-administered questionnaire. RESULTS Among the participants, 45.8% had been exposed to the campaign and 43.1% had taken up HIV testing in the last 6 months. In multivariate logistic regression analysis, exposure to the campaign [multivariate odds ratio (ORm) 2.55; 95% confidence interval (CI) 1.25, 5.19] and having had anal intercourse with a nonregular sex partner (ORm 2.36; 95% CI 1.05, 5.31) in the last 6 months were significantly associated with uptake of HIV testing in the last 6 months. CONCLUSIONS The campaign had relatively good reach in the target population and may have been useful to encourage them to take up HIV testing. Future campaigns promoting HIV testing among MSM in Hong Kong are still needed. Such programmes should consider making use of viral videos, having a longer project duration and developing culturally sensitive materials for non-Chinese-speaking MSM.

Guideline title Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Release date February 15, 2018 PRIOR VERSIONS: Cohen SH, Gerding DN, Johnson S, et al; Society for Healthcare Epidemiology of America; Infectious Diseases Society of America. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010; 31:431-55.Gerding DN, Johnson S, Peterson LR, et al. Clostridium difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol 1995;16:459-477. Developer IDSA and SHEA. Funding source Support for this guideline was provided by the IDSA and SHEA. Target population Children and adults with Clostridium difficile infections.

Capacity-oriented approaches to health interventions seek to empower the target population or community to manage the health issue themselves using resources they can control. Positive deviance, resilience and asset-based approaches are three such methods of developing and implementing health interventions. This study aimed to review the efficacy of interventions explicitly applying these methods in addressing childhood obesity using adiposity as the primary outcome, measured by standardized body mass index. The search strategy was developed and implemented across four electronic databases. Of the 181 records identified and screened, 11 studies were identified as using a capacity-oriented approach overall. Asset-based approaches (n = 8 studies) consisted of 47 880 participants, positive deviance (n = 2 studies) consisted of 781 participants, and resilience-based interventions (n = 1 study) consisted of 35 participants. The asset-based approaches were mixed, with three of the eight studies showing a significant reduction in adiposity, while the other five did not find a difference. The positive deviance and resilience-based studies showed signs of efficacy in reducing adiposity. There was significant design heterogeneity across studies, and varied interpretations and definitions of the approaches were used. Further work should attempt to achieve some consensus on the use of these approaches to facilitate comparison and advance the science of capacity-oriented interventions for childhood obesity.

GUIDELINE TITLE: Anaphylaxis—A 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis RELEASE DATE: April 2020 PRIOR VERSION: Anaphylaxis – a 2019 practice parameter and GRADE analysis DEVELOPER: American Academy of Allergy, Asthma & Immunology (AAAAI) and the American College of Allergy, Asthma, and Immunology (ACAAI) FUNDING SOURCE: None TARGET POPULATION: Adult and pediatric patients with anaphylaxis