Recommendations For Use Research Articles

The specifics of functioning of the active homing head exposed to ground surface clutter

Based on the determined ground surface clutter spectrum, we analyse the specific features of functioning of the active homing head (AHH) in relation to different types of radiated signals. With respect to AHH functioning, the paper gives recommendations for use of target data acquired against the Earth's background by monopulse synthetic aperture radars.

Délais administratifs des RTU, effet sur l’accès à l’innovation dans le mélanome

Melanoma has benefited in recent years from therapeutic innovations, which have improved overall survival of patients. France has developed a regulatory arsenal allowing faster access to innovative drugs before marketing authorization: temporary authorization for use (ATU) and temporary recommendation for use (RTU). We describe here the decision-making processes that led to the non-publication of the decree on the funding of three RTU in adjuvant melanoma therapy: nivolumab, pembrolizumab and the combination of dabrafenib and trametinib, and we analyse the fate of these drugs in order to quantify the potential loss of chance. On 03AUG2018, the French National Agency for Medicines and Health Product Safety (ANSM) published 3 RTU in order to give rapid access to major innovations in adjuvant melanoma therapy: nivolumab, pembrolizumab and the combination of dabrafenib and trametinib. These drugs have respectively demonstrated reductions in the risk of recurrence by 35%, 43% and 55% for target populations of 2200, 1900 and 650 patients per year. Despite a favourable opinion on reimbursement from the French National Authority for Health (HAS), the decrees on reimbursement will never be published, prohibiting the use of these products before the marketing authorisation, and depriving many patients of a potential cure. Despite a favourable opinion from scientists and health agencies for the rapid availability of a drug, the French public health code does not systematically imply access to a therapeutic innovation. The reform of access to innovation implemented on 01JUL2021 may help tackle this issue.

Happy Seeder Technologies in Punjab State of India: Lessons Learned from Farmers

Happy seeder has emerged as a way for a sustainable production system under the present rice-wheat cropping system in Punjab. The present survey was conducted during season 2019, comprising 50 randomly selected farmers on happy rabi seeder technology in Punjab, India, to understand the status, economic benefits, ease of access and complexity of technology, recommended practices (POP) followed and reasons for the non-adoption of recommended practices. The majority of the respondents used happy seeders in their field on a rent basis. The majority of the respondents (84 percent) observed a decrease in yield and net income by adopting a happy seeder, whereas input expenditures were reduced while using a happy seeder. The survey further revealed that the majority of the respondents applied more than the recommended dose of nitrogenous fertilizers and more seed rate. Refinement needs to be done in recommendations of use of happy seeder. Necessary incentives by way of subsidy and low rent on happy seeders to increase adoption of this technology should be made available by the concerned agencies.

Pulmonary artery catheterization in acute myocardial infarction complicated by cardiogenic shock: A review of contemporary literature.

Acute myocardial infarction (AMI) with left ventricular (LV) dysfunction patients, the most common cause of cardiogenic shock (CS), have acutely deteriorating hemodynamic status. The frequent use of vasopressor and inotropic pharmacologic interventions along with mechanical circulatory support (MCS) in these patients necessitates invasive hemodynamic monitoring. After the pivotal Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness trial failed to show a significant improvement in clinical outcomes in shock patients managed with a pulmonary artery catheter (PAC), the use of PAC has become less popular in clinical practice. In this review, we summarize currently available literature to summarize the indications, clinical relevance, and recommendations for use of PAC in the setting of AMI-CS.

Biometric personal data and their use in the investigation of criminal offences

The article is devoted to the analysis of biometric personal data, which is proposed to be considered as a source of information about a person and used during pre-trial investigation of criminal offences. The relevance of the research topic lies in the need to develop an optimal mechanism for using biometric personal data in the activities of pre-trial investigation bodies. The purpose of the research is to analyse the current international and national legislation on determining the place of biometric personal data in the criminal record system, implement their classification and provide recommendations for use by state bodies and individuals. To achieve this goal, the work used dialectical, historical-legal, formal-logical, dogmatic, structural-system and comparative-legal methods. It is proved that various types of biometric personal data accumulated in the criminal record system can be successfully used in the process of investigating criminal offences, and in some cases by individuals within the limits of their statutory powers. It was noted that along with the positive results of such activities, there are certain risks, namely, the presence of a threat of leakage and access to biometric data by unauthorized persons, as evidenced by the negative judicial practice of individual countries regarding unsatisfactory collection, processing, storage and use of biometric personal data. Taking into account the above, it is stated that the collection, processing and use of biometric personal data for the purpose of their use in the investigation of criminal offences must meet certain requirements, namely: the owner of the database of biometric personal data should only be the state represented by a special state body. Accordingly, the state should ensure the storage and protection of biometric personal data

Effects of additive corticosteroid therapy on 90-day survival in patients with community-onset pneumonia

IntroductionSystemic corticosteroid therapy is occasionally used as an additive therapy, especially for patients with severe pneumonia. However, its recommendation for use in patients with pneumonia varies worldwide, and its efficacy is unclear. MethodsAdult Japanese patients hospitalized with community-onset pneumonia between January and December 2012 were analyzed using the Diagnostic Procedure Combination database. The patients were classified into mild-to-moderate and severe groups using the A-DROP (age, dehydration, respiration, orientation, and blood pressure) system. The 90-day survival rate was evaluated between the presence or absence of corticosteroid treatment using the Kaplan-Meier method in the overall, mild-to-moderate and severe groups, respectively. The patients’ clinical characteristics were adjusted between the two groups using the inverse probability of treatment weighting method. ResultsAmong 123,811, 110,534 patients were classified as mild-to-moderate grade (corticosteroid group: 8,465, non-corticosteroid group: 102,069) and 13,277 patients were classified as severe grade (corticosteroid group: 1,338, non-corticosteroid group: 11,939). The 90-day survival rate was higher in the non-corticosteroid group than in the corticosteroid group in patients with pneumonia of overall grade (weighted hazard ratio [HR]: 1.36; P < 0.001) and those with mild-to-moderate grade (weighted HR: 1.46; P < 0.001). However, there were no significant differences in the outcomes between the two groups in those with severe grade (weighted HR: 1.08; P = 0.38). ConclusionsAdditive systemic corticosteroid therapy may be related to poor 90-day prognosis in patients with mild-to-moderate grade community-onset pneumonia, although it may not be positively associated with its prognosis in those with severe grade.

13. The Efficacy and Effectiveness of Pneumococcal Vaccines against Pneumococcal Pneumonia among Adults: A Systematic Review and Meta-Analysis

BackgroundTwo pneumococcal vaccines are currently recommended for use in U.S. adults: 23-valent pneumococcal polysaccharide vaccine (PPSV23) and 13-valent pneumococcal conjugate vaccine (PCV13). Recommendations for adult PCV13 use were supported by a large randomized-controlled trial (RCT) demonstrating PCV13 efficacy against pneumococcal pneumonia (PnPn) and vaccine-type (VT) PnPn in older adults. New pneumococcal conjugate vaccines are expected to be licensed for adults in late 2021 and recommendations for use among adults will be reviewed and revised, as needed. We conducted a systematic review to summarize evidence on the vaccine efficacy and effectiveness (VE) of PPSV23 and PCV13 against PnPn among adults.MethodsWe conducted a search of literature published from 1998 to February 2021 on PCV13 and PPSV23 VE studies using eight reference databases. Studies targeting adults with immunocompromising conditions were excluded. VE results with 95% confidence intervals (CI) were abstracted and stratified by vaccine product, outcome evaluated (PnPn and VT PnPn), study design, and effect measure. When applicable, random effects models were used to estimate pooled VE and I-squared statistic was reported to assess heterogeneity.ResultsOf 3,422 screened studies, we included 15 studies: three on PCV13 and 12 on PPSV23 (Table 1). In addition to the RCT, we identified two observational studies for PCV13 (Table 1); however, pooled VE of the observational studies was not estimated due to differences in methods for reporting results. Pooled PPSV23 VE against PnPn from two RCTs was 63% (95% CI: 31, 80 I2=0%). Pooled VE of PPSV23 against VT PnPn from three observational studies was 18% (95% CI: -35, 35 I2=38%). PPSV23 effectiveness against PnPn was limited with a pooled VE of 25% (95% CI: 7, 39 I2=78%) from nine observational studies. ConclusionFindings from observational studies supported PCV13 VE against VT PnPn reported in the RCT. Differences in the study design made the magnitude of PPSV23 effectiveness against PnPn and VT PnPn difficult to assess; however, findings from recent observational studies suggest PPSV23 provides limited protection against VT PnPn.Disclosures All Authors: No reported disclosures

A comparison of low‐cost behavioral observation software applications for handheld computers and recommendations for use

AbstractIn the field of animal behavior and behavioral ecology, many standardized methods to observe animal behavior were established in the last decades. While the protocols remained similar, behavioral researchers can take advantage of technological advancements to enter observations directly onto a handheld computer (phone, tablet, etc.), saving time and potentially increasing fidelity of recordings. However, we now have the choice between many different platforms for recording behavioral observations. Our challenge is choosing the most appropriate platform that fits a particular study question, research design, budget, and desired amount of preparatory time. Here, we review six low‐cost software applications for handheld computers that are available for real‐time entry of behavioral observations: Animal Behaviour Pro, Animal Observer, BORIS, CyberTracker, Prim8, and ZooMonitor. We discuss the preliminary decisions that have to be made about the study design, and we assess the six applications by providing the advantages and disadvantages of each platform and an overall application comparison. In our supplemental material, we illustrate the setup and data collection routines, and how to customize certain platforms so they will work more effectively for particular study aims or sampling methods. Our goal is to help researchers make calculated decisions about what behavioral observation platform is best for their study system and question.

Drone versus ambulance for blood products transportation: an economic evaluation study

BackgroundMedical transportation is an essential step in health care services, and includes ground, air and water transportation. Among the important uses of medical transportation is the delivery of blood products in the event of a clinical emergency. Drone technology is the latest technological advancement that may revolutionize medical transportation globally. Nonetheless, its economic evaluation is scant and insufficient, whilst its cost-effectiveness remains controversial. The aim of this study was to compare the cost-effectiveness of drone transportation versus the ambulance.MethodsThe setting of the study was within a developing nation. An economic evaluation study of drone versus ambulance for emergency blood products transportation between the Sabah Women and Children Hospital (SWACH) and the Queen Elizabeth II Hospital (QEH2) on Borneo Island was conducted using the Cost-Effectiveness Analysis (CEA) technique. The total cost of each mode of transportation was calculated using the Activity Based Costing (ABC) method. Travel time was used as a denominator to estimate the Incremental Cost Effectiveness Ratio (ICER).ResultsFor one clinical emergency in SWACH, a round trip of blood products transportation from SWACH to QEH2 costs RM1,266.02 (USD307.09) when using the ambulance, while the drone costs RM1,313.28 (USD319.36). The travel time for the drone was much shorter (18 min) compared to the ambulance (34 min). The Cost-Effectiveness Ratio (CER) of ambulance transportation was RM37.23 (USD9.05) per minute whilst the CER of drone transportation was RM72.96 (USD17.74) per minute. The ICER of drone versus ambulance was − 2.95, implying an increase of RM2.95 in cost for every minute saved using a drone instead of an ambulance.ConclusionAlthough drone transportation of blood products costs more per minute compared to the ambulance, the significantly shorter transport time of the drone offset its cost. Thus, we believe there is good economic potential for drone usage for blood products transportation in developing nations particularly if the drone price decreases and its operational lifespan increases. Our limitation of a non-clinical denominator used in this study leads to the recommendation for use of clinical outcomes in future studies.

Implementing Risk-Sharing Arrangements for Innovative Medicines: The Experience in Catalonia (Spain)

ObjectivesPublications assessing health and economic outcomes of risk-sharing arrangements (RSAs) are limited. Better knowledge of these outcomes would shed light on the pertinence of such arrangements, informing design improvements for the future. The aim of the study is to describe the different types of RSAs implemented in Catalonia and their health and economic outcomes. MethodsRetrospective descriptive analysis of RSAs implemented from January 2016 to December 2019 in the Catalan Health Service, CatSalut. Individual RSAs were reviewed and categorized according to standard RSA guidelines. Relevant health and economic outcomes pertaining to the RSAs were analyzed using aggregate data recorded in Catalan central registries. ResultsA total of 15 RSAs were implemented over the study period (10 of which are still ongoing). A total of 8 consisted of performance-linked reimbursements (PLRs) and 7 of cost-sharing arrangements (CSAs). The arrangements were implemented in the oncohematology (n = 11), rare disease (n = 3), and neurology (n = 1) areas. A total of 951 patients were included in PLR and 73% achieved the target health outcomes. Total medication costs were €9 295 755 of which 11% were refunded to CatSalut. CSAs involved 2066 patients and resulted in overall refunds of €1 349 564 (2.61%) for CatSalut. ConclusionsBoth PLRs and CSAs were used to manage the different uncertainties related to accessing innovative medicines in Catalonia. The data generated provide relevant information to inform decision-making, allowing an adaptation of the initial recommendation for use and access. Additional efforts are required to increase the RSA assessments and their publication.

Correction to ‘Molecular structure, DNA binding mode, photophysical properties and recommendations for use of SYBR Gold’

Correction to ‘Molecular structure, DNA binding mode, photophysical properties and recommendations for use of SYBR Gold’

ESCMID COVID-19 living guidelines: drug treatment and clinical management

ScopeIn January 2021, the ESCMID Executive Committee decided to launch a new initiative to develop ESCMID guidelines on several COVID-19-related issues, including treatment of COVID-19. MethodsAn ESCMID COVID-19 guidelines task force was established by the ESCMID Executive Committee. A small group was established, half appointed by the chair, and the remaining selected with an open call. Each panel met virtually once a week. For all decisions, a simple majority vote was used. A long list of clinical questions using the PICO (population, intervention, comparison, outcome) format was developed at the beginning of the process. For each PICO, two panel members performed a literature search with a third panellist involved in case of inconsistent results. Voting was based on the GRADE approach. Questions addressed by the guideline and recommendationsA synthesis of the available evidence and recommendations is provided for each of the 15 PICOs, which cover use of hydroxychloroquine, bamlanivimab alone or in combination with etesevimab, casirivimab combined with imdevimab, ivermectin, azithromycin and empirical antibiotics, colchicine, corticosteroids, convalescent plasma, favipiravir, remdesivir, tocilizumab and interferon β-1a, as well as the utility of antifungal prophylaxis and enoxaparin. In general, the panel recommended against the use of hydroxychloroquine, ivermectin, azithromycin, colchicine and interferon β-1a. Conditional recommendations were given for the use of monoclonal antibodies in high-risk outpatients with mild–moderate COVID-19, and remdesivir. There was insufficient evidence to make a recommendation for use of favipiravir and antifungal prophylaxis, and it was recommended that antibiotics should not be routinely prescribed in patients with COVID-19 unless bacterial coinfection or secondary infection is suspected or confirmed. Tocilizumab and corticosteroids were recommended for treatment of severe COVID-19 but not in outpatients with non-severe COVID-19. ScopeThe aim of the present guidance is to provide evidence-based recommendations for management of adults with coronavirus disease 2019 (COVID-19). More specifically, the goal is to aid clinicians managing patients with COVID-19 at various levels of severity including outpatients, hospitalized patients, and those admitted to intensive care unit. Considering the composition of the panel, mostly clinical microbiologists or infectious disease specialists with no pulmonology or intensive care background, we focus only on pharmacological treatment and do not give recommendations on oxygen supplement/support. Similarly, as no paediatricians were included in the panel; the recommendations are only for adult patients with COVID-19. Considering the current literature, no guidance was given for special populations such as the immunocompromised.

Analytical formalism for calculations of parameters needed for quantitative analysis by X-ray photoelectron spectroscopy

Analytical formalism for calculations of parameters needed for quantitative analysis by X-ray photoelectron spectroscopy

The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5-11 Years - United States, November 2021.

The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. On August 23, 2021, the Food and Drug Administration (FDA) approved a Biologics License Application (BLA) for use of the Pfizer-BioNTech COVID-19 vaccine, marketed as Comirnaty (Pfizer, Inc.), in persons aged ≥16 years (1). The Pfizer-BioNTech COVID-19 vaccine is also recommended for adolescents aged 12-15 years under an Emergency Use Authorization (EUA) (1). All persons aged ≥12 years are recommended to receive 2 doses (30 μg, 0.3 mL each), administered 3 weeks apart (2,3). As of November 2, 2021, approximately 248 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged ≥12 years in the United States.* On October 29, 2021, FDA issued an EUA amendment for a new formulation of Pfizer-BioNTech COVID-19 vaccine for use in children aged 5-11 years, administered as 2 doses (10 μg, 0.2 mL each), 3 weeks apart (Table) (1). On November 2, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation† for use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years for the prevention of COVID-19. To guide its deliberations regarding recommendations for the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework§ and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.¶ The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years under an EUA is interim and will be updated as additional information becomes available. The Pfizer-BioNTech COVID-19 vaccine has high efficacy (>90%) against COVID-19 in children aged 5-11 years, and ACIP determined benefits outweigh risks for vaccination. Vaccination is important to protect children against COVID-19 and reduce community transmission of SARS-CoV-2.

Use of Auditory Training and Its Influence on Early Cochlear Implant Outcomes in Adults.

Assess associations between postcochlear implant (CI) auditory training and early outcomes related to speech recognition and CI quality of life (CIQOL). Longitudinal, prospective cohort. Tertiary academic center. Seventy-two adults undergoing cochlear implantation for bilateral severe-to-profound hearing loss. Self-reported use of three categories of auditory training post-CI activation: (1) face-to-face training (e.g., speech pathologist), (2) passive home-based training (e.g., listening to audiobooks), and (3) computer-based training (e.g., interactive software). Change in Consonant-Nucleus-Consonant phoneme (CNCp), CNC word (CNCw), AzBio sentences in quiet, and CIQOL-35 Profile global and domain scores from pre-CI to 3-month post-CI. Of 72 patients, 52 (72.2%) used an auditory training resource. Of all patients, 18.4% used face-to-face training, 58.3% passive home-based training, and 33.3% computer-based training. At 3 months post-CI, use of any training was associated with greater improvement in speech recognition (d-range = 0.57-0.85) and global and domain-specific CIQOL scores, except entertainment (d-range = -0.33 to 0.77). Use of computer-based training demonstrated the greatest effect, with larger improvements in speech recognition (CNCp: d = 0.69[0.03,1.35]; CNCw: d = 0.80[0.14,1.46]; AzBio: d = 1.11[0.44,1.77]) and global and all domain-specific CIQOL scores (d-range = 0.05-1.35). Controlling for age, sex, household income, and use of multiple training resources, computer-based training remained the strongest positive predictor of speech recognition and CIQOL improvement, with significant associations with CNCp (ß = 33.07[1,43,64.719]), AzBio (ß = 33.03[5.71,60.35]), and CIQOL-global (ß = 10.92[1.15,20.70]) score improvement. Our findings provide preliminary evidence-based recommendations for use of specific auditory training resources for new adult CI recipients. Auditory training, especially self-directed computer software, resulted in improved speech recognition and CIQOL outcomes after 3 months and are widely available for CI users.

Patient Characteristics and Temporal Changes in Anticoagulation Treatment Patterns in Patients Diagnosed with Cancer-Associated Thrombosis: An Oscar-US Analysis

Background: Although guidelines include direct-acting oral anticoagulants (DOACs) as an alternative to low molecular weight heparins (LMWHs) for treatment of cancer associated venous thrombosis (CAT), specific recommendations for selection of patients for DOAC treatment vary. Recommendations for use of DOACs are driven predominantly by perceptions of risk: benefit ratio (often associated with different cancer subtypes). We sought to assess patient characteristics and temporal changes in DOAC (vs. LMWH) utilization in patients being treated in routine practice for CAT.Methods: This analysis is part of the Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States (OSCAR-US) program. OSCAR-US is an ongoing study utilizing longitudinal patient-level medical record data from Optum for 91+ million patients seen at 700+ hospitals and 7,000+ clinics across the US. To be included in the present study, adult patients had to be diagnosed with active (primary or metastatic) cancer, undergone hospitalization, emergency department or observation unit admission associated with a primary International Classification of Diseases (ICD)-9th or -10 th revision diagnosis code for venous thromboembolism (VTE) between January 2013 and September 2020, received a DOAC or LMWH on day 7 of CAT treatment, and been active in the data set for at least 12 months prior to the CAT. Cohort assignment was based upon anticoagulant received on day 7 to increase the study's likelihood of appropriately classifying patients into their intended long-term treatment group. We defined active cancer as any cancer associated with ongoing treatment with chemotherapy, immunotherapy, radiation, or recent surgery; the presence of metastatic disease (regardless of time from initial cancer diagnosis); or provider encounter with a primary diagnosis code for cancer within the 6 months prior to the CAT. We excluded patients with an alternative indication for anticoagulation use or evidence of anticoagulation during the 12 months prior (per written prescription or patient self-report). For this analysis, year of CAT diagnosis was grouped into three mutually exclusive categories (2013-2015, 2016-2018, and 2019-2020) to represent early DOAC availability for VTE, peri-DOAC CAT trials and post-CAT guideline recommendation periods. Categorical data were reported as percentages, while continuous data were reported as means ± standard deviations (SDs). Chi-square and independent sample t-tests were used to test for differences in characteristics and treatment patterns between cohorts.Results: In total, 95,072 adult patients experiencing a VTE-related hospitalization, emergency department or observation unit visit were identified. Of these, 14,377 (15.1%) met our pre-specified criteria for active cancer; including 84.7% who received a cancer treatment modality within 6-months and/or had metastatic disease (Table). Though a majority (76.0%) of patients received parenteral therapy as their first anticoagulant upon CAT diagnosis; on day 7 of CAT management, 5325 (52.0%) were receiving a DOAC and 4925 (48.0%) a LMWH. Mean age of patients was 65.2±13.7 years, body mass index (BMI) was 29.9±7.7 kg/m2 and 55.9% were women. Pulmonary embolism (PE)±deep vein thrombosis (DVT) was present in 47.2% of patients and more frequent in patients treated with LMWH than a DOAC on day 7 (p<0.001). The most common cancer types were lung (18.3%) genitourinary (13.5%), breast (12.7%) and colorectal (10.5%) (Figure). The proportion of patients treated with a DOAC increased substantially for all cancers over the three time periods evaluated (27.5% to 55.9% to 73.2%, p<0.001). This temporal relationship of increasing DOAC use (vs. LMWH) remained consistent across individual cancer subtypes (p<0.001 for all). Mean anticoagulant treatment duration was 193±143 days for the entire cohort and was longer in patients treated with DOACs vs. LMWHs (226±138 vs. 147±138 days, p<0.001).Conclusions: In this US population, DOACs were increasingly being utilized for the management of CAT patients and for longer treatment durations than LMWHs. The finding of increasing frequency in use of DOACs vs. LMWHs appeared consistent across all major cancer subtypes. Given their common use, future analyses should evaluate the real-world effectiveness and safety of DOACs compared to LMWHs within individual cancer subtypes. [Display omitted] DisclosuresColeman: Bayer AG: Consultancy, Honoraria, Research Funding; Janssen Scientific Affairs LLC: Consultancy, Honoraria, Research Funding; Alexion Pharmaceuticals: Research Funding. Abdelgawwad: Bayer AG: Current Employment. Psaroudakis: Bayer AG: Current Employment. Fatoba: Bayer AG: Current Employment. Rivera: Bayer AG: Current Employment. Brobert: Bayer AG: Current Employment.

Biomarker and Companion Diagnostics-A Review of Medicinal Products Approved by the European Medicines Agency.

Background: An increasing number of medicines authorised in Europe recommend or require biomarker-based patient selection. For some of these the use of a companion diagnostic (CDx), a subset of in vitro diagnostics (IVDs), to identify patient populations eligible for a specific medicinal product may be required. The information and recommendations of use of a medicinal product for which a CDx is required is particularly important to healthcare professionals for correct patient identification.Methods: We reviewed the existing information in SmPCs and European Public Assessment Reports (EPARs) of EU medicinal products approved via the centralised procedure at EMA where reference was made to biomarker testing, including by CDx, for patient selection.Results: The results show that varying levels of detail are provided for the biomarker and the diagnostic test, including variability in where the information was presented. The overall results demonstrate transparent but sometimes heterogeneous reporting of CDx in the SmPC and EPAR.Conclusions: With the introduction of the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices, medicines regulatory authorities' will be required to be consulted during the review of CDx conformity assessment and so, there is opportunity for more consistent and transparent information on CDx to be provided in the SmPC and EPAR.

Assessing Glycemic Control Using CGM for Women with Diabetes in Pregnancy.

Diabetes during pregnancy increases the risk of maternal and fetal complications. This article reviews the types of CGM currently available, the glucose metrics which correlate with pregnancy outcomes, endocrine organization recommendations, clinical considerations for CGM implementation, and anticipated directions for future research. CGM use during pregnancy is increasing, and recommendations for use have been incorporated into many organizations' consensus guidelines. Increased time spent within a target range of 63-140mg/dL and lower mean glucose are associated with lower risk of neonatal complications including large for gestational age infants. Use of CGM during pregnancy can detect postprandial and nocturnal hyperglycemia missed by self-monitoring of blood glucose (SMBG) which can be used for prognosis and to guide pharmacologic interventions. The use of continuous glucose monitoring (CGM) during pregnancies complicated by type 1, type 2, and gestational diabetes has been shown to improve outcomes.

Silica Nanoparticles as a Probable Anti-Oomycete Compound Against Downy Mildew, and Yield and Quality Enhancer in Grapevines: Field Evaluation, Molecular, Physiological, Ultrastructural, and Toxicity Investigations.

Downy mildew is the most destructive disease of grapevines in the regions of relatively warm and humid climate causing up to 50% yield losses. Application of silicon- (Si-) based products have been extensively studied against various oomycete, fungal, bacterial, and viral plant diseases, but studies on Si application in their nanosize are limited. In this study, the field application of silica nanoparticles (SiNPs) on Thompson Seedless grapevines (H4 strain) infected with downy mildew was evaluated. In addition, molecular, physiological, ultrastructural, and toxicity investigations were also conducted. The obtained results revealed that spraying of grapevines with SiNPs at 150 ppm significantly overexpressed the transcription factor jasmonate and ethylene-responsive factor 3 recording 8.7-fold, and the defense-related genes β-1,3-glucanase (11-fold), peroxidase (10.7-fold) pathogenesis-related-protein 1 (10.6-fold), and chitinase (6.5-fold). Moreover, a reduction up to 81.5% in the disease severity was achieved in response to this treatment. Shoot length and yield per grapevine were considerably enhanced recording up to 26.3 and 23.7% increase, respectively. The berries quality was also improved. Furthermore, this treatment led to an enhancement in the photosynthetic pigments, induction of phenolic and ascorbic acid contents, an increase in the activity of peroxidase and polyphenol oxidase enzymes, and a reduction in the cellular electrolyte leakage, lipid peroxidation, and H2O2 content. Scanning electron microscopy observations showed an increase up to 86.6% in the number of closed stomata and a reduction up to 55% in the average stomatal pore area in response to this treatment. Observations of the transmission electron microscopy showed ultrastructural alterations in the cells of a grapevine leaf due to the infection with downy mildew, including plasmolysis and disruption of the cellular components, abnormal chloroplasts, and thickening of the cell wall and cell membrane. These abnormal alterations were reduced in response to SiNPs spray. In contrast, this study also showed that this treatment had considerable cytotoxic and genotoxic effects at this direct dose/concentration. So, additional investigations to determine the SiNPs residue in the produced edible plant parts are urgently needed. In addition, the pre-harvest interval, toxicity index, and risk assessment should be evaluated before any recommendation for use.

NOAA and BOEM Minimum Recommendations for Use of Passive Acoustic Listening Systems in Offshore Wind Energy Development Monitoring and Mitigation Programs

Offshore wind energy development is rapidly ramping up in United States (U.S.) waters in order to meet renewable energy goals. With a diverse suite of endangered large whale species and a multitude of other protected marine species frequenting these same waters, understanding the potential consequences of construction and operation activities is essential to advancing responsible offshore wind development. Passive acoustic monitoring (PAM) represents a newer technology that has become one of several methods of choice for monitoring trends in the presence of species, the soundscape, mitigating risk, and evaluating potential behavioral and distributional changes resulting from offshore wind activities. Federal and State regulators, the offshore wind industry, and environmental advocates require detailed information on PAM capabilities and techniques needed to promote efficient, consistent, and meaningful data collection efforts on local and regional scales. PAM during offshore wind construction and operation may be required by the National Oceanic and Atmospheric Administration and Bureau of Ocean Energy Management through project-related permits and approvals issued pursuant to relevant statutes and regulations. The recommendations in this paper aim to support this need as well as to aid the development of project-specific PAM Plans by identifying minimum procedures, system requirements, and other important components for inclusion, while promoting consistency across plans. These recommendations provide an initial guide for stakeholders to meet the rapid development of the offshore wind industry in United States waters. Approaches to PAM and agency requirements will evolve as future permits are issued and construction plans are approved, regional research priorities are refined, and scientific publications and new technologies become available.