Significant Turning Point: Common Buzzard (Buteo buteo) Exposure to Second-Generation Anticoagulant Rodenticides in the United Kingdom.

Second-generation anticoagulant rodenticides (SGARs) are widely used to control rodent populations, resulting in the serious secondary exposure of predators to these contaminants. In the United Kingdom (UK), professional use and purchase of SGARs were revised in the 2010s. Certain highly toxic SGARs have been authorized since then to be used outdoors around buildings as resistance-breaking chemicals under risk mitigation procedures. However, it is still uncertain whether and how these regulatory changes have influenced the secondary exposure of birds of prey to SGARs. Based on biomonitoring of the UK Common Buzzard (Buteo buteo) collected from 2001 to 2019, we assessed the temporal trend of exposure to SGARs and statistically determined potential turning points. The magnitude of difenacoum decreased over time with a seasonal fluctuation, while the magnitude and prevalence of more toxic brodifacoum, authorized to be used outdoors around buildings after the regulatory changes, increased. The summer of 2016 was statistically identified as a turning point for exposure to brodifacoum and summed SGARs that increased after this point. This time point coincided with the aforementioned regulatory changes. Our findings suggest a possible shift in SGAR use to brodifacoum from difenacoum over the decades, which may pose higher risks of impacts on wildlife.

Increasing adolescents' physical activity levels through a comprehensive school-based physical activity program: study protocol of the cluster randomized controlled trial Active School.

BACKGROUND: The positive effects of regular physical activity on children and adolescents' physical and mental health are well-established. Despite these health benefits, most Swiss adolescents do not meet WHO's recommended level of physical activity, which includes a daily minimum of 60 min of moderate-to-vigorous physical activity. Due to their inclusivity, schools are identified as a key setting to promote physical activity. Recently, the comprehensive school physical activity program (CSPAP), in which teachers as physical activity leaders (PALs) play a crucial role to advance comprehensive school-based physical activity promotion, has been discussed. However, such comprehensive approaches are still lacking in Switzerland, and specific PAL trainings do not exist. Therefore, the aim of this study is to implement and evaluate Active School, a comprehensive school-based physical activity program for Swiss secondary schools with integrated PAL training. METHODS/DESIGN: A cluster randomized controlled trial (RCT) involving 12 secondary schools (6 experimental, 6 waiting control schools) will assess baseline data and effectiveness of Active School at 12 and 24 months. Active School includes five components based on the CSPAP. Each school is encouraged to set individual physical activity goals in this regard. This process is guided by the PALs, who will participate in professional development training before and during Active School implementation. As a primary outcome, students' moderate-to-vigorous physical activity will be assessed via accelerometers. As secondary outcomes, inactivity, light physical activity, step counts, aerobic fitness and coordination will be measured, and students' general wellbeing, learning behavior, and multiple psychosocial measures related to physical activity will be assessed by questionnaires. The effectiveness evaluation is accompanied by a process evaluation that focuses on the implementation outcomes of dose of delivery, reach, feasibility, and sustainability. A mixed methods approach, including ripple effect mapping, will be employed to reconstruct and understand the implementation process. DISCUSSION: This study will be the first to implement and evaluate a CSPAP in the Swiss school system. The specific PAL training and the simultaneous application of effectiveness and process evaluation are considered strengths of the study. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00033362). Date of registration: January 25, 2024. Retrospectively registered.

Has Regulatory Action Reduced Human Exposure to Flame Retardants?

Flame retardant (FR) exposure has been linked to several environmental and human health effects. Because of this, the production and use of several FRs are regulated globally. We reviewed the available records of polybrominated diphenyl ethers (PBDEs) and hexabromocyclododecanes (HBCDDs) in human breast milk from literature to evaluate the efficacy of regulation to reduce the exposure of FRs to humans. Two-hundred and seven studies were used for analyses to determine the spatial and temporal trends of FR exposure. North America consistently had the highest concentrations of PBDEs, while Asia and Oceania dominated HBCDD exposure. BDE-49 and -99 indicated decreasing temporal trends in most regions. BDE-153, with a longer half-life than the aforementioned isomers, typically exhibited a plateau in breast milk levels. No conclusive trend could be established for HBCDD, and insufficient information was available to determine a temporal trend for BDE-209. Breakpoint analyses indicated a significant decrease in BDE-47 and -99 in Europe around the time that regulation has been implemented, suggesting a positive effect of regulation on FR exposure. However, very few studies have been conducted globally (specifically in North America) after 2013, during the time when the most recent regulations have been implemented. This meta-analysis provides insight into global trends in human exposure to PBDEs and HBCDD, but the remaining uncertainty highlights the need for ongoing evaluation and monitoring, even after a compound group is regulated.

Improved Anthropogenic Mercury Emission Inventories for China from 1980 to 2020: Toward More Accurate Effectiveness Evaluation for the Minamata Convention.

Anthropogenic mercury (Hg) emission inventories are crucial for the effectiveness evaluation of the Minamata Convention on Mercury. In this study, we developed an integrated Dynamic Inventory for Mercury Emission (DIME) model and improved the accuracy of emission estimates for primary sources in China. Long-term historical speciated Hg emission inventories for China were established. The total Hg emissions increased from 217.0 t in 1980 to 357.8 t in 2020 with a peak value of 506.6 t in 2010. Three stages with distinct leading drivers were identified. At Stage 1 (1980-1997), Hg emissions doubled with the rapid growth of economy; the driver was offset by the increase of dust and SO2 control measures at Stage 2 (1997-2010) except for cement production; and co-benefits from strict control measures induced the decoupling of Hg emissions from the economy at Stage 3 (2010-2020). The ultralow emission (ULE) retrofits in key industries had pronounced Hg removal efficiencies. Large emission reduction potential still exists in the cement industry. The improved emission estimation methods for key sectors, the consistency in methodology for historical Hg emission inventories, and the more accurate spatial distribution of speciated Hg emissions in this study provide a practical toolkit for the effectiveness evaluation of the Minamata Convention.

Cost-effectiveness analysis of COVID-19 tests in the unified health system.

BACKGROUND: To evaluate the cost-effectiveness ratio and economic impact of the Rapid Antigen Test (TR-Ag) to replace RT-PCR for the detection of the new Coronavirus in the Unified Health System (SUS). METHODS: This is a cost-effectiveness analysis. Clinical protocols were used for the diagnosis of COVID-19 at the São José Municipal Hospital, located in the city of Itaberá-SP. The Incremental Cost-Effectiveness Ratio (ICER) was divided into two scenarios. In the first, the accuracy reported by the test manufacturers was included, and in the second, the cost resulting from a systematic review. Both were compared with the performance of the RT-PCR test. The increase in diagnoses was chosen as a health outcome and absenteeism was used as a criterion for assessing the economic impact. RESULTS: The analysis resulted in incremental cost-effectiveness ratios of R$ 42,136.67 and R$ 68,329.73 for every thousand tests, according to the accuracy of the manufacturers' TR-Ag tests and what is reported in the literature in relation to RT-PCR, respectively. The average value found for the RT-PCR test (R$ 202.87) represents an increase of 165.32% in cost in relation to the value found for the TR-Ag. 4,305 tests were performed between April 2020 and December 2021 at the referral hospital. Also, maintaining the use of RT-PCR as the first choice for diagnosing COVID-19 and regulating absenteeism in the economically active population could have an impact of up to R$ 1,022,779.68 on municipal management. CONCLUSION: It is concluded that the TR-Ag are configured as a cost-effective alternative for the SUS in the detection of the new Coronavirus. The strategy becomes economically favorable for the expansion of testing, combating the COVID-19 pandemic and reducing the impact on the local economy. However, studies are needed to validate the accuracy of the tests so that economic evaluations on the subject are more assertive.

Evaluation of the Effectiveness of Telehealth Chronic Disease Management System: Systematic Review and Meta-analysis.

BACKGROUND: Long-term daily health monitoring and management play a more significant role in telehealth management systems nowadays, which require evaluation indicators to present patients' general health conditions and become applicable to multiple chronic diseases. OBJECTIVE: This study aims to evaluate the effectiveness of subjective indicators of telehealth chronic disease management system (TCDMS). METHODS: We selected Web of Science, ScienceDirect, Scopus, Cochrane library, IEEE, and Chinese National Knowledge Infrastructure and Wanfang, a Chinese medical database, and searched papers published from January 1, 2015, to July 1, 2022, regarding randomized controlled trials on the effectiveness of the telehealth system on patients with chronic diseases. The narrative review summarized the questionnaire indicators presented in the selected studies. In the meta-analysis, Mean Difference (MD) and Standardized Mean Difference (SMD) with a 95% CI were pooled depending on whether the measurements were the same. Subgroup analysis was conducted if the heterogeneity was significant, and the number of studies was sufficient. RESULTS: Twenty RCTs with 4153 patients were included in the qualitative review. Seventeen different questionnaire-based outcomes were found, within which quality of life, psychological well-being (including depression, anxiety, and fatigue), self-management, self-efficacy, and medical adherence were most frequently used. Ten RCTs with 2095 patients remained in meta-analysis. Compared to usual care, telehealth system can significantly improve the quality of life (SMD 0.44; 95% CI 0.16-0.73; P=.002), whereas no significant effects were found on depression (SMD -0.25; 95% CI -0.72 to 0.23; P=.30), anxiety (SMD -0.10; 95% CI -0.27 to 0.07; P=.71), fatigue (SMD -0.36; 95% CI -1.06 to 0.34; P<.001), and self-care (SMD 0.77; 95% CI -0.28-1.81; P<.001). In the subdomains of quality of life, telehealth statistically significantly improved physical functioning (SMD 0.15; 95% CI 0.02 to 0.29; P=.03), mental functioning (SMD 0.37; 95% CI 0.13-0.60; P=.002), and social functioning (SMD 0.64; 95% CI 0.00-1.29; P=.05), while there was no difference on cognitive functioning (MD 8.31; 95% CI -7.33 to 23.95; P=.30) and role functioning (MD 5.30; 95% CI -7.80 to 18.39; P=.43). CONCLUSIONS: TCDMS positively affected patients' physical, mental, and social quality of life across multiple chronic diseases. However, no significant difference was found in depression, anxiety, fatigue, and self-care. Subjective questionnaires had the potential ability to evaluate the effectiveness of long-term telehealth monitoring and management. However, further well-designed experiments are warranted to validate TCDMS's effects on subjective outcomes, especially when tested among different chronically ill groups.

Economic evaluation of fluoride varnish application in preschoolers: A systematic review.

BACKGROUND: Fluoride varnish (FV) is a convenient way of professionally applying fluoride in preschoolers. However, its modest anticaries effect highlights the need for economic evaluations. AIM: To assess economic evaluations reporting applications of FV to reduce caries incidence in preschoolers. DESIGN: We included full economic evaluations with preschool participants, in which the intervention was FV and the outcome was related to dentin caries. We searched in CENTRAL; MEDLINE via PubMed; WEB OF SCIENCE; EMBASE; SCOPUS; LILACS; BBO; and BVS Economia em saúde, OpenGrey, and EconoLit. Clinical trial registers, thesis and dissertations, and meeting abstracts were hand searched, as well as 11 dental journals. Risk of bias in the included studies was assessed using the Philips' and Drummond's (full and simplified) tools. RESULTS: Titles and abstracts of 2871 articles were evaluated, and 200 were read in full. Eight cost-effectiveness studies were included: five modeling and three within-trial evaluations. None of the studies gave sufficient information to allow a thorough assessment using the bias tools. We did not combine the results of the studies due to the great heterogeneity among them. Four studies reported that FV in preschool children was a cost-effective measure, but in one of these studies, sealants and fluoride toothpaste were more cost-effective measures than the varnish, and three studies used limited data that compromised the generalizability of their results. The other four studies showed a large increase in costs due to the application of varnish and/or low cost-effectiveness. CONCLUSION: We did not find convincing overall evidence that applying FV in preschoolers is an anticaries cost-effective measure. The protocol of this systematic review is available at Open Science Framework (https://osf.io/xw5va/).

Cost-effectiveness and Acceptance in Children and Parents of the Hall Technique: Systematic Review of Clinical Trials.

AIMS: The purpose of this systematic review was to evaluate the cost-effectiveness and acceptance of children and their parents of the Hall technique (HT) for dental rehabilitation in pediatric dentistry. BACKGROUND: The approach of the HT is that of minimally invasive treatment of the dental element and is used exclusively on primary molars. Various studies in the literature point to HT as a restorative option well accepted by children and parents and quite predictable, with low retreatment rates and good cost-effectiveness for the management of primary molars with carious lesions. However, no systematic review in the literature has approached randomized clinical trials on these topics to produce a high level of evidence and help establish clinical HT protocols. REVIEW RESULTS: Eight articles were selected for the systematic review. The HT was more cost-effective than procedures using other restorative materials. Regarding acceptance, in terms of esthetics, high percentages of satisfaction were reported for parents and children, with a divergence between studies in the comparison of esthetic preference with atraumatic restorative treatment. However, when considering crown cementation pain, comfort, anxiety, preference, and satisfaction, the HT was generally better evaluated when compared to other restorative materials. CONCLUSION: The HT is an excellent restorative option when considering cost-effectiveness and acceptance and is recommended for use in daily clinical practice. CLINICAL SIGNIFICANCE: Results indicate that HT is superior to other restorative materials regarding its acceptance by children and parents in terms of pain, comfort, anxiety, and crown preference and satisfaction. There were also high percentages of satisfaction with esthetics. Hall technique may initially appear expensive for dentists, but its effectiveness over time and the lesser need for consultations and reinventions ensure better cost-benefit than other restorative materials. How to cite this article: Valentim FB, Moreira KMS, Carneiro VC, et al. Cost-effectiveness and Acceptance in Children and Parents of the Hall Technique: Systematic Review of Clinical Trials. J Contemp Dent Pract 2023;24(12):1016-1025.

Enhancing Scientific Support for the Stockholm Convention's Implementation: An Analysis of Policy Needs for Scientific Evidence.

The Stockholm Convention is key to addressing the global threats of persistent organic pollutants (POPs) to humanity and the environment. It has been successful in identifying new POPs, but its national implementation remains challenging, particularly by low- and middle-income Parties. Concerted action is needed to assist Parties in implementing the Convention's obligations. This analysis aims to identify and recommend research and scientific support needed for timely implementation of the Convention. We aim this analysis at scientists and experts from a variety of natural and social sciences and from all sectors (academia, civil society, industry, and government institutions), as well as research funding agencies. Further, we provide practical guidance to scientists and experts to promote the visibility and accessibility of their work for the Convention's implementation, followed by recommendations for sustaining scientific support to the Convention. This study is the first of a series on analyzing policy needs for scientific evidence under global governance on chemicals and waste.

A Real-Time Effectiveness Evaluation Method for Remote Sensing Satellite Clusters on Moving Targets.

Recently, remote sensing satellites have become increasingly important in the Earth observation field as their temporal, spatial, and spectral resolutions have improved. Subsequently, the quantitative evaluation of remote sensing satellites has received considerable attention. The quantitative evaluation method is conventionally based on simulation, but it has a speed-accuracy trade-off. In this paper, a real-time evaluation model architecture for remote sensing satellite clusters is proposed. Firstly, a multi-physical field coupling simulation model of the satellite cluster to observe moving targets is established. Aside from considering the repercussions of on-board resource constraints, it also considers the consequences of the imaging's uncertainty effects on observation results. Secondly, a moving target observation indicator system is developed, which reflects the satellite cluster's actual effectiveness in orbit. Meanwhile, an indicator screening method using correlation analysis is proposed to improve the independence of the indicator system. Thirdly, a neural network is designed and trained for stakeholders to realize a rapid evaluation. Different network structures and parameters are comprehensively studied to determine the optimized neural network model. Finally, based on the experiments carried out, the proposed neural network evaluation model can generate real-time, high-quality evaluation results. Hence, the validity of our proposed approach is substantiated.

SWAT model application for evaluating agricultural conservation practice effectiveness in reducing phosphorous loss from the Western Lake Erie Basin.

Lake Erie is threatened by eutrophication and harmful algal blooms due to excess nutrient loading from agricultural sources. Agricultural conservation practices (ACPs) have been developed and implemented to reduce nutrient losses but estimating ACP effectiveness is challenging. The Soil and Water Assessment Tool (SWAT) has been used to investigate ACP effectiveness for water quality improvement. Many SWAT applications have been developed by different investigators to evaluate ACP effectiveness for reducing nutrient, particularly phosphorus (P), loading in the agriculturally-dominated Western Lake Erie Basin (WLEB). Our objective is to establish what has been achieved by past modeling research and make suggestions for future applications and improvements. We synthesized the findings of 28 SWAT modeling studies within the WLEB. Models generally performed satisfactorily against accepted criteria for streamflow and sediment, but performance for P loads, like soluble reactive P, was mostly "unsatisfactory". The "unsatisfactory" performance maybe due to imperfections and idealizations in model formulations and/or parameterization. Thus, simulations of P transport and transformation processes need improvement. In addition, model parameter selection is the key part of model set-up. Most SWAT modeling studies used default values during initial set-up, then performed calibration and validation. It was found that the calibrated P related parameter values varied widely across different studies, even within the same watershed with some values unrealistic for the study areas. The phenomena of different combinations of model parameters producing similar outputs indicates equifinality. Equifinality in the baseline model may impact results when ACPs are incorporated. Furthermore, the unrealistic values used in ACP assessment undermine the credibility of ACP effectiveness. Future model applications should try to re-examine the calibrated P parameters and make sure they are realistic for the study area as well as reduce equifinality by constraining the model with characterization of watershed conditions, better understanding of hydrologic processes, and parameter values based on real-world observations. In summary, future model applications should focus on improving P transport and transformation processes, using measured watershed characteristics for parameterization, and improving reflections of climate change, which could result in more accurate assessments of ACP effectiveness to meet targeted goals.

Estimation of the Width of Uncertainty in Care Consumption and Costs When Using Common Data Collection Tools in Economic Evaluations: A Benchmark for Sensitivity Analyses.

OBJECTIVES: This study aimed to evaluate the uncertainty related to the use of common collection tools to assess costs in economic evaluations compared with an exhaustive administrative database. METHODS: A pragmatic study was performed using preexisting cost-effectiveness studies. Patients were probabilistically matched with themselves in the French National Health Data System (Système National des Données de Santé [SNDS]), and all their reimbursed hospital and ambulatory care data during the study were extracted. Outcomes included the ratio of the number of each type of resources consumed using trial data (case report forms for ambulatory care and local hospital data for hospital care) versus the SNDS and the ratio of corresponding costs. Mean ratios and 95% confidence intervals (CIs) were calculated using bootstrapping. The impact of the collection tool on the result of the economic evaluation was calculated with the difference in costs between the 2 treatment arms with both collection methods. RESULTS: Five cost-effectiveness studies were included in the analysis. A total of 397 patients had the SNDS hospital data, and 321 had ambulatory care data. Common collection tools underestimated hospital admissions by 13% (95% CI 8-20), corresponding costs by 5% (95% CI 2-14), and ambulatory acts by 41% (95% CI 33-51), with large variations in costs depending on the study. There was no change in the economic conclusion in any study. CONCLUSIONS: The use of common collection tools underestimates healthcare resource consumption and its associated costs, particularly for ambulatory care. Our results could provide useful evidence-based estimates to inform sensitivity analyses' parameters in future cost-effectiveness analyses.

Tracking POPs in Global Air from the First 10 Years of the GAPS Network (2005 to 2014).

The Global Atmospheric Passive Sampling (GAPS) network, initiated in 2005 across 55 global sites, supports the global monitoring plan (GMP) of the Stockholm Convention on Persistent Organic Pollutants (POPs) by providing information on POP concentrations in air on a global scale. These data inform assessments of the long-range transport potential of POPs and the effectiveness evaluation of chemical regulation efforts, by observing changes in concentrations over time. Currently, measurements spanning 5-10 sampling years are available for 40 sites from the GAPS Network. This study was the first time that POP concentrations in air were reported on a global scale for an extended time period and the first to evaluate worldwide trends with an internally consistent sample set. For consistency between sampling years, site- and sample specific sampling rates were calculated with a new, public online model, which accounts for the effects of wind speed variability. Concentrations for legacy POPs in air between 2005 and 2014 show different trends for different organochlorine pesticides (OCPs) and polychlorinated biphenyls (PCBs). The POPs discussed in this study were chosen due to being the most frequently detected, with detection at the majority of sites. PCB, endosulfan, and hexachlorocyclohexane (HCH) concentrations in air are decreasing at most sites. The global trends reflect global sources and recycling of HCH, ongoing emissions from old stockpiles for PCBs, and recent use restrictions for endosulfan. These chlorinated OCPs continue to present exposure threat to humans and ecosystems worldwide. Concentrations of other OCPs, such as chlordanes, heptachlor and dieldrin, are steady and/or declining slowly at the majority of sites, reflecting a transition from primary to secondary sources (i.e., re-emission from reservoirs where these POPs have accumulated historically) which now control ambient air burdens.

Effectiveness Evaluation Method of Application of Mobile Communication System Based on Factor Analysis.

The application mode of army mobile communication networks is closely related to combat mission and application environment. Different combat missions and application environments result in different network structures and different service priorities, which requires a semi-automatic system to support the network scheme design. Therefore, evaluating the efficiency of network schemes generated by automatic planning is a problem that needs to be urgently addressed. In the past, researchers have proposed a variety of methods to evaluate the effectiveness of mobile communication systems, most of which are based on simulation methods and ignore the historical data of network usage. This paper studies an effectiveness evaluation method of mobile communication network design schemes and proposes a design scheme for the evaluation and optimization of network plans. Furthermore, the improved method of effectiveness evaluation based on factor analysis is discussed in detail. The method not only effectively uses historical data but also reduces the amount of data collection and calculation. In order to adapt to the preference requirements of different task scenarios, a decision preference setting method based on cluster analysis is proposed, which can render the output optimization result more reasonable and feasible.

Jamming Strategy Optimization through Dual Q-Learning Model against Adaptive Radar.

Modern adaptive radars can switch work modes to perform various missions and simultaneously use pulse parameter agility in each mode to improve survivability, which leads to a multiplicative increase in the decision-making complexity and declining performance of the existing jamming methods. In this paper, a two-level jamming decision-making framework is developed, based on which a dual Q-learning (DQL) model is proposed to optimize the jamming strategy and a dynamic method for jamming effectiveness evaluation is designed to update the model. Specifically, the jamming procedure is modeled as a finite Markov decision process. On this basis, the high-dimensional jamming action space is disassembled into two low-dimensional subspaces containing jamming mode and pulse parameters respectively, then two specialized Q-learning models with interaction are built to obtain the optimal solution. Moreover, the jamming effectiveness is evaluated through indicator vector distance measuring to acquire the feedback for the DQL model, where indicators are dynamically weighted to adapt to the environment. The experiments demonstrate the advantage of the proposed method in learning radar joint strategy of mode switching and parameter agility, shown as improving the average jamming-to-signal radio (JSR) by 4.05% while reducing the convergence time by 34.94% compared with the normal Q-learning method.

[Effectiveness of an educational video about infant crying on prevention of shaken baby syndrome among pregnant Japanese women and their partners].

Objectives　Previous studies have shown that educating new mothers or pregnant women about infant crying, may prevent shaken baby syndrome (SBS). However, no studies in Japan have examined the effectiveness of educational materials during pregnancy. This study aims to determine whether pregnant women and their partners improve their knowledge about infant crying and SBS, after watching an educational video created by the Ministry of Health, Labour, and Welfare.Methods　The study was conducted from April 1, 2013, to March 31, 2014, in 46 municipalities nationwide. Pregnant women and their partners, who participated in prenatal classes, watched the educational video and responded to pre- and post-questionnaires that included questions about: the characteristics of parents and family, and knowledge about infant crying and SBS. Out of the 4769 respondents who completed the questionnaires, responses of 4647 respondents with knowledge about infant crying and SBS were analyzed. We asked six questions about infant crying, such as "When an infant cries it is always a sign that something is wrong", and two questions about SBS, such as "Shaking a baby is a good way to help a baby stop crying" using a 4-point Likert scale (0-3 points). The total scores were calculated and placed within the range of 0 to 100, where higher scores indicated better knowledge. These scores were then compared for the pre- and post-conditions. Furthermore, a stratified analysis was performed based on respondents' characteristics and a regression analysis was conducted to examine the differences in knowledge categorized by these characteristics.Results　The scores displayed a significant increase in knowledge about infant crying and SBS by 17.5 points (95% CI; 17.1-17.9) and 6.8 points (95% CI; 6.3-7.2) respectively, after watching the educational video. The results of the stratified analysis found that the effect of the intervention did not differ depending on characteristics such as age, sex, education, and prevalence of depression. Furthermore, our regression analysis on the scores of knowledge about infant crying and SBS found that the increases in knowledge were more pronounced among males and couples having their first child. Increase in knowledge about infant crying was more pronounced among those who were not depressed, while increase in knowledge about SBS was more pronounced among those who answered "unexpected but happy" for their feelings about pregnancy.Conclusion　The educational video on infant crying and shaken baby syndrome was effective in increasing knowledge about infant crying and SBS among couples during pregnancy, regardless of their characteristics.

[Use of exercise tests and physical training in pulmonary rehabilitation]. / Ispol'zovanie nagruzochnykh testov i fizicheskikh trenirovok v legochnoi reabilitatsii.

The use of pulmonary rehabilitation reduces symptoms, improves life quality and exercise tolerance. The article presents indications for physical training, their characteristics and assessment of their effectiveness in the rehabilitation of patients with chronic lung diseases. It was noted that the execution of exercise tests (a monitoring with a progressive load increase on a bicycle ergometer or treadmill, a test with a constant load, a 6-minute walk test, a shuttle test with an increasing load and a shuttle test with a constant load) is appropriate for physical training before rehabilitation course. Physical endurance training programs are an essential component of pulmonary rehabilitation. Strength training, flexibility training and upper limb exercises give a good additional effect. To assess the effectiveness after rehabilitation programs, it is advisable to perform tests with physical activity. To assess the effectiveness of rehabilitation, the constant load exercise test and the constant load shuttle test are more sensitive to changes than the increasing load tests.

Pre/post effectiveness evaluation of updated additional risk minimisation measures for an orphan disease: Myozyme (alglucosidase alfa) Safety Information Packet.

BACKGROUND: The alglucosidase alfa (Myozyme®) Safety Information Packet ("previous SIP") was updated to improve readability and content ("updated SIP"). We compared the previous and updated SIPs. METHODS: A two-wave pre-post multicountry survey was conducted among health care professionals (HCPs) who prescribed or monitored patients on alglucosidase alfa in the largest European Union ("EU5") countries and Poland. Wave (W) 2 started 15 months after completion of W1 and the implementation of the updated SIP. Changes between the waves were analysed. RESULTS: Forty-six HCPs (34 physicians/12 nurses) participated in W1 and 52 in W2 (42 physicians/10 nurses); 22 participated in both waves. Nonsignificant differences were observed between waves 1 and 2 for awareness (75.6% in W1 and 82.4% in W2) and receipt (77.7% in W1 and 74.5% in W2) of the SIP, reading (88.6% in W1 and 89.5% in W2) and usage (88.2% in W1 and 89.5% in W2) among receivers of the SIP, or the overall knowledge about immunological testing (61.1% in W1 vs 55.1% in W2). Frequency of performance of immunological testing was significantly higher in W2 than in W1 (50.3% vs 34.4%; P = .024) with a tendency for increases in the appropriate performance of all types of testing in W2. CONCLUSIONS: Both versions of the SIP showed relatively high awareness, receipt, reading, and usage, with an overall trend for most measures to improve numerically in W2. The updated SIP did not require further changes.

Linking process indicators and clinical/safety outcomes to assess the effectiveness of abatacept (ORENCIA) patient alert cards in patients with rheumatoid arthritis.

PURPOSE: Patient alert cards (PACs) for abatacept (ORENCIA) inform patients and healthcare professionals (HCPs) about the risk of infections and allergic reactions. The study evaluates the effectiveness of the PACs in rheumatoid arthritis patients and HCPs, using process indicators (awareness, receipt, utility, knowledge, behaviour) and outcomes. METHODS: Surveys of patients and HCPs in five European countries. A retrospective chart review permitted linking clinical and safety outcomes with survey responses. RESULTS: Data on 190 patients and 79 HCPs (50 physicians and 29 nurses) were analysed. Sixty percent of patients were aware of the PAC, of whom 95% had received it. Knowledge of risk of infection was higher among patients who had received the PAC vs those who had not (64% vs 46%; P = .013). Infections leading to hospitalisation increased with decreasing patient survey global scores: scores of ≥67%, 34%-67% and ≤ 33% were associated with hospitalisation rates of 2.5%, 5.2% and 8.4%, respectively (P = .4). Among HCPs 90% were aware and 68% had accessed the PAC. More nurses than physicians were aware (93% vs 88%), had accessed (78% vs 74%), read (90% vs 59%), distributed (81% vs 66%) and explained the content (94% vs 43%) of the PAC. Knowledge of risk of infection was higher among HCPs who had (91%) vs those who had not (73%) accessed the PAC (P = .053). CONCLUSIONS: PACs were effective in improving knowledge of key safety messages in patients and HCPs. This novel study design bridges the gap of linking process indicators with outcomes in the same patients, thereby strengthening the clinical relevance of patient surveys.

The utility of real-world evidence for benefit-risk assessment, communication, and evaluation of pharmaceuticals: Case studies.

PURPOSE: In recent years, novel types of real-world evidence (RWE) have played a role in various decision-making processes relating to medicinal products, including regulatory approval, patient access, health technology assessment, safety monitoring, clinical use, and post-approval lifecycle management. We therefore reviewed the potential utility of RWE in the cycle of medicinal product benefit-risk (BR) assessment, communication/risk minimization and evaluation ("BRACE"). METHODS: A convenience sample of illustrative studies was drawn from the published literature and examined. Specifically, we examined the purpose for using RWE, the type of RWE used, its novelty and how it might be integrated with other data and activities of the BRACE cycle, and how it contributed to regulatory decision-making. RESULTS: Eight studies were selected with each illustrating a different activity in the BRACE cycle ranging from BR assessment in the preapproval setting, post-approval assessment of safety or effectiveness, communicating BR information to patients and healthcare professionals, and evaluating the effectiveness of risk minimization initiatives to support a positive BR balance. CONCLUSIONS: RWE has an important role in informing regulatory decision-making regarding the BR management of medicines. With increasing digitalization, facilitating data collection and stakeholder engagement in health, this role is only expected to expand in the future. To reach the full potential of RWE, both regulators and sponsors will need to be familiar with a range of existing and emerging methods for generating and analyzing such evidence appropriately and achieve convergence regarding how different types of RWE can best be used to inform BR management and decision-making.