Adoption Of Guidelines Research Articles

WHO's adoption of SAGER guidelines and GATHER: setting standards for better science with sex and gender in mind

WHO's adoption of SAGER guidelines and GATHER: setting standards for better science with sex and gender in mind

Imaging Practices in Patients with Plasma Cell Dyscrasias across the Asian Myeloma Network - Survey Results and Recommendations

Objective: Though consensus imaging guidelines from International Myeloma Working Group (IMWG) for the detection of bone and marrow lesions in plasma cell disorders are available, significant challenges remain in adoption of such guidelines in Asia. The objectives of this study were: (1) To survey, document and evaluate the imaging practices in plasma cell disorders across Asian Myeloma Network (AMN) member countries and (2) To identify factors influencing decision making in choosing the imaging modalities with a view to explore barriers and solutions. Methods: AMN Members from China, Japan, Republic of Korea, Malaysia, Taiwan, Thailand and Singapore participated in the bone imaging work group organized during the 6 th AMN summit in Sep 2022 at Singapore. Members discussed the prevailing bone imaging practices and how they relate to IMWG recommendations. A bone imaging survey questionnaire was then designed from these inputs and circulated to the wider AMN members. The results were collated and analyzed. Results & Discussion: Forty-Eight responses were received from 37 public tertiary or academic hospitals, 9 from peripheral hospitals and 2 from private hospitals. With regards to precursor plasma cell disorders (MGUS / SMM Vs MM), the preferred imaging modalities for screening bone disease in patients suspected to have myeloma were skeletal survey (SS) (n=13, 27%), whole body low dose CT (WBLDCT) (n=13, 27%) and PET CT (n=14, 29%). The preferred mode for 1 st line imaging in patients with confirmed newly diagnosed myeloma was PET CT (n=25, 52%) however half of the participants opted for SS (n=7, 15%), WBLDCT (n=10, 21%) and whole-body MRI (WBMRI) (n=6, 13%). Using SS prior to myeloma treatment or to differentiate SMM from MM can lead to significant under-recognition of bone disease and its consequences on disease classification and impact on treatment. Centers which are performing SS but have compatible CT scanners could consider adopting a WBLDCT protocol which is relatively easy and cost-effective. Preferred first-line imaging options for Plasmacytoma and EMD were largely appropriate with 70-80% opting for PET CT or WBMRI. However, for response assessment in MM, the majority chose PET CT or MRI, some members or institutions are still using SS or WBLDCT. While CT scan might be able to show some sclerotic healing or a worsening lytic component, SS is unlikely to provide any useful information in this situation and should be avoided to reduce unnecessary radiation exposure. At least 5 participants indicated that they do not perform routine imaging in newly diagnosed multiple myeloma for disease response assessment. Barriers identified in establishing cross-sectional imaging service include lack of financial reimbursement or subsidies, equipment, or personnel availability like the presence of nuclear medicine or specialized radiologists. While 81% of participants reported financial reimbursements for SS, only about 50% reported subsidies for WBMRI (56%) or PET CT (54%). One shortfall of this study is that our survey was conducted within the framework of an academic myeloma community and while it may not be representative of the practices in the whole region, the use of sub-optimal imaging like SS underlines the need for standardisation and adoption of cross-sectional imaging. Conclusion: There is considerable variation in imaging practices for precursor plasma cell disorders and myeloma in centres across Asia. Resource limitation, specifically lack of financial subsidies for imaging, infrastructure or lack of experienced personnel all remain as major challenges in the implementation of standardized imaging practice for myeloma in Asia. However increased adoption of cross-sectional imaging in large tertiary centres are to be welcomed and suggest that in these centres, practices do closely mirror those in the IMWG recommendations. Increasing awareness of the potentially catastrophic nature of myeloma bone disease and the preventive role that cross sectional imaging could provide, representations and dialogues with healthcare funders to this aspect of myeloma care, incorporation of low dose CT protocols to help move away from skeletal survey in centres which already have CT scanners as well as myeloma patient and Physician education could all be useful tools to enhance bone imaging standards in Asia.

Characteristics, healthcare utilization, and outcomes of patients with HER2-low breast cancer.

Treatment for HER2-low [defined as ImmunoHistoChemistry (IHC) 1 + or 2 + and negative/normal in Situ Hybridization (ISH)] breast cancer patients is rapidly evolving, yet we lack critical information about the HER2-low population. We conducted a retrospective cohort study of women aged 18years or older diagnosed with breast cancer between 2010 and 2016 in North Carolina. Analyses were conducted for the overall cohort and a stage IV sub-cohort. We examined demographic and clinical characteristics, and characterized prevalence of HER2-low disease and healthcare utilization. We estimated adjusted rate ratios for the association between HER2 classifications and utilization outcomes, and hazard ratios for 3-year all cause mortality (stage IV only). The overall and stage IV cohorts included 12,965 and 635 patients, respectively. HER2-low patients represented more than half of both cohorts (59% overall, 53% stage IV). HER2-low patients were more likely than IHC 0 patients to have hormone receptor (HR)-positive disease. In the stage IV cohort, HER2-low patients were more likely to be Black (26% vs. 16% IHC 0, p = 0.0159). In both cohorts, rates of hospitalizations were slightly higher among HER2-low patients. There were no survival differences between HER2-low and IHC 0 among stage IV patients. New treatment options for HER2-low breast cancer may have potential for significant impact at the population level particularly for patients with stage IV disease. In light of racial differences between HER2-low and IHC 0 patients observed in our cohort, research- and practice-based efforts to ensure equitable adoption of new treatment guidelines for patients with HER2-low metastatic breast cancer will be essential.

A Review of the Ethics of Artificial Intelligence and Its Applications in the United States

This study is focused on the ethics of Artificial Intelligence and its application in the United States, the paper highlights the impact AI has in every sector of the US economy and multiple facets of the technological space and the resultant effect on entities spanning businesses, government, academia, and civil society. There is a need for ethical considerations as these entities are beginning to depend on AI for delivering various crucial tasks, which immensely influence their operations, decision-making, and interactions with each other. The adoption of ethical principles, guidelines, and standards of work is therefore required throughout the entire process of AI development, deployment, and usage to ensure responsible and ethical AI practices. Our discussion explores eleven fundamental 'ethical principles' structured as overarching themes. These encompass Transparency, Justice, Fairness, Equity, Non-Maleficence, Responsibility, Accountability, Privacy, Beneficence, Freedom, Autonomy, Trust, Dignity, Sustainability, and Solidarity. These principles collectively serve as a guiding framework, directing the ethical path for the responsible development, deployment, and utilization of artificial intelligence (AI) technologies across diverse sectors and entities within the United States. The paper also discusses the revolutionary impact of AI applications, such as Machine Learning, and explores various approaches used to implement AI ethics. This examination is crucial to address the growing concerns surrounding the inherent risks associated with the widespread use of artificial intelligence.

Systematic Review and Meta-Analysis of Nonoperative Management for SVS Grade II Blunt Traumatic Aortic Injury

SVS Grade II blunt traumatic aortic injury is defined as intramural hematoma with or without external contour abnormality. It is uncertain whether this aortic injury pattern should be treated with endovascular stent-grafting or nonoperative measures. Since the adoption of the SVS Guidelines on endovascular repair of blunt traumatic aortic injury, the practice pattern for management of grade II injuries has been heterogenous. The objective of the study was to report natural history outcomes of grade II blunt traumatic aortic injury. A systematic review of published traumatic aortic injury studies was performed. Online database searches were current to November 2022. Eligible studies included data on aortic injuries that were both managed nonoperatively and classified according to the SVS 2011 Guidelines. Data points on all-cause mortality, aorta-related mortality and early aortic intervention were extracted and underwent meta-analysis. The methodology was conducted in accordance with PRISMA guidance. Thirteen studies were included in the final analysis with a total of 204 cases of SVS grade II blunt traumatic aortic injury treated nonoperatively. The outcomes rates were estimated at 10.4% (95% CI 6.7% - 14.9%) for all-cause mortality, 2.9% (95% CI 1.1% - 5.7%) for aorta-related mortality and 3.3% (95% CI 1.4% - 6.2%) for early aortic intervention. The studies included in the analysis were of fair quality with a mean Downs and Black score 15 (±1.8). Grade II blunt traumatic aortic injury follows a relatively benign course with few instances of aortic-related mortality. Death in the setting of this injury pattern is more often attributable to sequelae of multisystem trauma and not directly related to aortic injury. The current data supports nonoperative management and imaging surveillance for grade II blunt traumatic aortic injury instead of endovascular repair. Longer-term effects on the aorta at the site of injury are unknown.

Concordant care in sentinel lymph node omission following Choosing Wisely® recommendations at a comprehensive cancer center

BackgroundIn 2016, the SSO and ABIM released a Choosing Wisely® guideline stating SLNB can be safely omitted in women ≥70 with HR ​+ ​HER-invasive breast cancer. No study evaluating concordance of care with this guideline has been performed within a comprehensive cancer center. MethodsFrom 2005 to 2020, there were 382 patients with cT1-2N0 invasive carcinoma ER+/PR+ and HER2-identified as having undergone SLNB. These patients were then separated into two groups; those in the pre-guideline concordance cohort (2005–2015) and those in the post-guideline concordance (2016–2020) cohort. Axillary management concordance was trended over time. Results382 patients from 2005 to 2020 with HR ​+ ​HER- IBC were identified. No difference was seen in SLNB pre-versus post-guidelines (p ​= ​0.35). Increased concordance was noted as age increased (p ​= ​0.0068) and adjuvant radiation therapy exclusion (p ​< ​0.0001) post-guideline release. Concordance improved over the years post-guideline release (R2 ​= ​0.45). ConclusionsSurgical guideline adoption occurs over time but may also be affected by outside decisions and factors. Further study into patterns of guideline adoption may facilitate improving adherence to guidelines.

Prevalence and Sociodemographic Correlates of Meeting the 24-Hour Movement Guidelines Among Low-Income Brazilian Older Adults With Chronic Diseases.

This study examined the prevalence and sociodemographic correlates of meeting individual behavior and 24-hr movement behavior guidelines among Brazilian older adults with chronic diseases. The sample comprised 273 older adults aged ≥60years (80.2% women) with chronic diseases from Recife, Pernambuco, Brazil. Sociodemographic variables were self-reported, while 24-hr movement behaviors were assessed by accelerometry. Participants were classified as meeting (or not meeting) individual and integrated recommendations for moderate-to-vigorous physical activity (MVPA), sedentary behavior, and sleep duration. No participant met the 24-hr movement behavior guidelines, while only 8.4% met integrated MVPA/sleep recommendations. The prevalence of meeting recommendations of MVPA, sedentary behavior, and sleep was 28.9%, 0.4%, and 32.6%, respectively. Discrepancies according to sociodemographic variables on meeting MVPA recommendations existed. The findings show the need for dissemination and implementation strategies to foster adoption of the 24-hr movement behavior guidelines among Brazilian older adults with chronic diseases.

The need to develop tailored tools for improving the quality of thematic bibliometric analyses: Evidence from papers published in Sustainability and Scientometrics

AbstractPurposeThe aim of this article is to explore up to seven parameters related to the methodological quality and reproducibility of thematic bibliometric research published in the two most productive journals in bibliometrics, Sustainability (a journal outside the discipline) and Scientometrics, the flagship journal in the field.Design/methodology/approachThe study identifies the need for developing tailored tools for improving the quality of thematic bibliometric analyses, and presents a framework that can guide the development of such tools. A total of 508 papers are analysed, 77% of Sustainability, and 23% published in Scientometrics, for the 2019-2021 period.FindingsAn average of 2.6 shortcomings per paper was found for the whole sample, with an almost identical number of flaws in both journals. Sustainability has more flaws than Scientometrics in four of the seven parameters studied, while Scientometrics has more shortcomings in the remaining three variables.Research limitationsThe first limitation of this work is that it is a study of two scientific journals, so the results cannot be directly extrapolated to the set of thematic bibliometric analyses published in journals from all fields.Practical implicationsWe propose the adoption of protocols, guidelines, and other similar tools, adapted to bibliometric practice, which could increase the thoroughness, transparency, and reproducibility of this type of research.Originality/valueThese results show considerable room for improvement in terms of the adequate use and breakdown of methodological procedures in thematic bibliometric research, both in journals in the Information Science area and journals outside the discipline.

Lead Extraction-Indications, Procedure, and Future Directions.

Cardiac implantable electronic device (CIED) implantation has steadily increased in the United States owing to increased life expectancy, better access to health care, and the adoption of updated guidelines. Transvenous lead extraction (TLE) is an invasive technique for the removal of CIED devices, and the most common indications include device infections, lead failures, and venous occlusion. Although in-hospital and procedure-related deaths for patients undergoing TLE are low, the long-term mortality remains high with 10-year survival reported close to 50% after TLE. This is likely demonstrative of the increased burden of comorbidities with aging. There are guidelines provided by various professional societies, including the Heart Rhythm Society, regarding indications for lead extraction and management of these patients. In this paper, we will review the indications for CIED extraction, procedural considerations, and management of these patients based upon the latest guidelines.

Prevalence and correlates of meeting the Canadian 24-hour movement guidelines among a sample of Canadian parents during the COVID-19 pandemic

BackgroundParents’ own movement behaviours can influence those of their children, thus contributing to the health and well-being of the whole family. Parents experienced a shift in work and childcare responsibilities during the COVID-19 pandemic. This may have led to a reduction in their healthy movements. This study examined the prevalence and correlates of meeting vs. not meeting the individual and combined recommendations within the Canadian 24-hour movement guidelines for adults among a sample of Canadian parents during the second wave (October 2020) of the COVID-19 pandemic.MethodsParents of children aged 5–17 years (n = 1,477) responded to a cross-sectional survey conducted in October 2020. A total of 21 self-reported correlates, including parental and child demographics, and change in family movement behaviours/characteristics were assessed. Parental movement behaviours were reported and classified as meeting or not meeting each of the guidelines. Associations between correlates and meeting each of the guidelines were examined using multiple logistic regression.ResultsThe proportion of parents who met the moderate-vigorous physical activity (MVPA), recreational screen time, sleep duration and combined guidelines were 21.2, 51.0, 66.1, and 9.1%, respectively. Being a parent ≥ 45 years old, having a university education, and higher levels of outdoor play were associated with meeting the combined guidelines. Age, dwelling type, family hobbies, and outdoor play were associated with meeting the MVPA recommendation. Employment status, education level, dog ownership, children’s age, family physical activity, and levels of distress were associated with meeting the recreational screen time recommendation. Geographical region, dwelling type, and levels of distress were associated with meeting the sleep duration recommendation.ConclusionsFew Canadian parents were meeting the combined 24-hour movement guidelines recommendations for MVPA, recreational screen time, and sleep six months into the COVID-19 pandemic. Several socio-demographic, behavioural, and COVID-19-related factors emerged as significant correlates of meeting vs. not meeting the individual and/or combined recommendations within the guidelines. The findings provide various avenues for which to target future movement behaviour interventions and guideline adoption for parents.

Advancing co-production for transformative change by synthesizing guidance from case studies on the sustainable management and governance of natural resources

Co-production has become paramount for scientists, practitioners and social groups of Indigenous peoples and local communities of rural and urban areas to deliver transformative changes that enhance sustainability. Co-production should result in knowledge that is credible, legitimate and usable to enable sustainable outcomes effectively. However, this is not always the case due to challenges related to differences between scientific and Indigenous and local knowledge, as well as inherent power imbalances. The literature emphasises that these challenges are often triggered by rigid scientific theories and postures, dominant practices, and time-money limitations that co-production projects involve. This happens despite the adoption of guidelines recommended in the literature. We investigate the role of these challenges and guidelines in the generation of credible, legitimate, usable, and effective knowledge. We analyse this role in 13 co-production cases focused on sustainable transformative changes linked with the management and governance of natural resources across the globe. Despite challenges varying between groups and contexts, credibility, usability, and effectiveness are promoted simultaneously, especially when co-production empowers social actors via legitimate processes. Scientists and practitioners do so, through creative and flexible reshaping of existing knowledge and worldviews with a focus on common goals that link sustainability and livelihoods. They conceptualise a mutual understanding of knowledge and that is deemed trustworthy feasible to use in their socioecological context. Our findings complement existing scholarship on co-production, exploring the credibility of situated knowledge and its practical effectiveness together with its commonly addressed legitimacy and usability. A focus on the practices of different actors, including dynamics that are external to co-production, and changes in the scientific and social status quo, are needed to advance co-production effectiveness.

Adherence to the Canadian Thoracic Society Chronic Obstructive Pulmonary Disease Pharmacotherapy Guidelines in a real-world hospital setting

RATIONALE The Canadian Thoracic Society (CTS) publishes chronic obstructive pulmonary disease (COPD) guidelines with recommendations regarding which inhaled pharmacotherapy to prescribe. A minimal amount is known about the implementation of these guidelines in routine clinical practice. OBJECTIVES The main goals of this review were to assess the adherence to the CTS COPD pharmacotherapy guidelines in a real-world setting of patients with a severe exacerbation, to determine predictors of increased guidelines adoption, and to review if subjects leaving the hospital without recommended inhaled therapy had a higher rate of readmission for COPD within 30 days. METHODS Patients treated in 2022 at Montfort Hospital for a COPD exacerbation (hospitalization or emergency department) were reviewed. Medication lists at the time of presentation and discharge were charted in addition to patient clinical characteristics and COPD admissions up to 30 days after the initial assessment. A comparison of COPD patients with and without recommended inhaled therapy optimization was performed. MEASUREMENTS AND MAIN RESULTS A total of 214 patients were admitted for a COPD exacerbation. From this sample, 111 were candidates for review of their inhaled therapy as per the CTS guidelines; however, only 22 (20%) received recommended optimization. Subjects who were admitted to inpatient units and those with spirometry results on file were more likely to receive appropriate pharmacotherapy at discharge (both p = 0.02). Patients not optimized as per the guidelines were at higher risk of readmission for a COPD exacerbation within 30 days (p = 0.02). CONCLUSIONS Adherence to the CTS COPD pharmacotherapy guidelines was low in a real-world hospital setting. Interventions that would help increase their adoption would result in improved patient outcomes.

Enhancing Ada Compliance for Websites and Online Applications: A Heuristic Evaluation Approach

The guidance provided by the ADA regarding online applications can be unclear and has led to the adoption of Web Content Accessibility Guidelines (WCAG) 2.0 and Section 508 of the Rehabilitation Act of 1973 as the standards for assessing online accessibility and achieving ADA compliance. While these standards are helpful, they are not perfect and have faced criticism due to usability concerns. As a result, our objective is to create review heuristics that combine the guidance of WCAG 2.0 and Section 508, which can serve as a practical and effective tool for assessing web ADA compliance. The heuristics function similar to a usability heuristic evaluation, which has been proven successful for decades. This article will first focus on developing the ADA compliance heuristics, then it demonstrates the use of the heuristics.

Projected impact of guidelines on incidence of venous thromboembolism after cesarean delivery in the United States

BackgroundThere is large variation in recommended for postcesarean delivery venous thromboembolism (VTE) prophylaxis among commonly used guidelines. ObjectivesThe aim of the study is to estimate implications of adoption of VTE prevention guidelines for rates of receipt of VTE prophylactic therapy and VTE following cesarean delivery (CD). MethodsWe used administrative data from the 2015-2019 Nationalwide Readmissions Database to identify cesarean deliveries and rates of VTE stratified by risk factors, leading to different prophylactic strategies based on several national guidelines. We used input parameters from the literature to construct a hybrid decision tree/Markov model to project the implications of guideline adoption on VTE rates for the first 6 weeks following delivery. ResultsAdoption of either the 2011 American College of Obstetricians and Gynecologists or the 2018 American Society for Hematology guidelines would avert a relatively small proportion (5%) of VTE cases, albeit with little low-molecular-weight heparin (LMWH) use (87-115 doses per 1000 CD patients). The 2012 American College of Chest Physicians guidelines were predicted to be more effective at averting VTE (21.2% reduction) with more LMWH usage (570 doses per 1000 deliveries). The 2015 Royal College of Obstetricians and Gynaecologists guidelines and universal use of 6 weeks of LMWH would avert an even larger proportion of cases (37.4% and 57.6%, respectively), at the cost of much higher rates of LMWH utilization (7233 doses per 1000 patients and 38 648 doses per 1000 patients). ConclusionsAdoption of different guidelines would have notably varying implications for clinical practice and potential for alteration of the national rate of VTE following CD.

Review of Statistical and Methodological Issues in the Forensic Prediction of Malingering from Validity Tests: Part II-Methodological Issues.

Forensic neuropsychological examinations to detect malingering in patients with neurocognitive, physical, and psychological dysfunction have tremendous social, legal, and economic importance. Thousands of studies have been published to develop and validate methods to forensically detect malingering based largely on approximately 50 validity tests, including embedded and stand-alone performance and symptom validity tests. This is Part II of a two-part review of statistical and methodological issues in the forensic prediction of malingering based on validity tests. The Part I companion paper explored key statistical issues. Part II examines related methodological issues through conceptual analysis, statistical simulations, and reanalysis of findings from prior validity test validation studies. Methodological issues examined include the distinction between analog simulation and forensic studies, the effect of excluding too-close-to-call (TCTC) cases from analyses, the distinction between criterion-related and construct validation studies, and the application of the Revised Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2) in all Test of Memory Malingering (TOMM) validation studies published within approximately the first 20years following its initial publication to assess risk of bias. Findings include that analog studies are commonly confused for forensic validation studies, and that construct validation studies are routinely presented as if they were criterion-reference validation studies. After accounting for the exclusion of TCTC cases, actual classification accuracy was found to be well below claimed levels. QUADAS-2 results revealed that extant TOMM validation studies all had a high risk of bias, with not a single TOMM validation study with low risk of bias. Recommendations include adoption of well-established guidelines from the biomedical diagnostics literature for good quality criterion-referenced validation studies and examination of implications for malingering determination practices. Design of future studies may hinge on the availability of an incontrovertible reference standard of the malingering status of examinees.

Addressing resistance to adopting relevant health promotion recommendations with strategic health communication

Health promotion is a complex communication process that involves identifying and recommending adoption of the best available evidence-based guidelines for addressing the most dangerous health risks confronting modern society. Despite the steady proliferation of major scientific advances in knowledge about the best available strategies for preventing and responding to many of these health risks, it has been frustratingly difficult to mobilize widespread adoption of recommended evidence-based health promotion guidelines by at-risk populations around the globe. Even worse, there has been a growing number of frustrating instances of active public resistance to adopting evidence-based public health guidelines concerning participation in screening efforts for detecting dangerous health risks as early as possible (when many health risks are most responsive to treatment), getting vaccinated help build public immunity to deadly infectious diseases, actively seeking needed health care to address health problems, following health care recommendations (including adhering with prescribed medications and treatment regimens), as well as integrating important behavioral practices into daily living, such as good nutrition, regular exercise, and strategies to prevent the spread of disease (like social distancing and wearing protective masks in public settings to reduce the spread of airborne infectious diseases). Effective health communication is needed to help members of the public, especially those who are at greatest risk for poor health outcomes (such as elderly, homeless, disenfranchised, disabled, immigrant, and those suffering from multiple co-morbidities) to recognize the seriousness and salience of public health threats, engage in recommended actions to minimize the likelihood of contracting these health problems, and to respond effectively when they encounter serious health risks. This article examines the significant challenges to communicating relevant health information to those who are confronting serious health risks, especially to members of the most vulnerable populations, and suggests strategies for effectively using communication messages and media for promoting adoption of recommended health promotion actions.

2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV,

The 16th Workshop on Recent Issues in Bioanalysis (16th WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on theICH M10 BMV final guideline (focused on this guideline training, interpretation, adoption and transition); mass spectrometry innovation (focused on novel technologies, novel modalities, and novel challenges); and flow cytometry bioanalysis (rising of the 3rd most common/important technology in bioanalytical labs) were the special features of the 16th edition. As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues. This 2022 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2022 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1A) covers the recommendations on Mass Spectrometry and ICH M10. Part 1B covers the Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine. Part 2 (LBA, Biomarkers/CDx and Cytometry) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 15 of Bioanalysis, issues 15 and 14 (2023), respectively.

2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.

The 16th Workshop on Recent Issues in Bioanalysis (16th WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on ICH M10 BMV final guideline (focused on this guideline training, interpretation, adoption and transition); mass spectrometry innovation (focused on novel technologies, novel modalities, and novel challenges); and flow cytometry bioanalysis (rising of the 3rd most common/important technology in bioanalytical labs) were the special features of the 16th edition. As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues. This 2022 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2022 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations on LBA, Biomarkers/CDx and Cytometry. Part 1 (Mass Spectrometry and ICH M10) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 15 of Bioanalysis, issues 16 and 14 (2023), respectively.

Antibiotic pollution: The forerunner of global health catastrophe?

AbstractThe rapid enhancement in the emergence of resistant bacteria occurring globally has endangered the efficacy of the conventional antibiotics causing threat to human at a large extent. Traces of antimicrobial drugs and their metabolites in various natural environments have resulted in enhancement of antimicrobial resistance (AMR) among the natural flora and fauna of the water resources. Contamination of the environment with antimicrobials encourages the bacteria to evolve ways to acquire competence which may result in the conversion of antibiotic susceptible strains to resistant bacteria. The spread of AMR varies from planktonic to sessile forms of the bacterial species by cross resistance or horizontal gene transfer resulting in blooming populations that would otherwise can be kept in check. This has created a tremendous threat to human health due to the enhancement in the resistance of microorganisms and other microbes to various types of antimicrobial drugs. Rampant use of antibiotics and improper detection of antibiotics from the sewages of the factories has resulted in the enhancement of concentration of antibiotics in the environment. This has resulted in the enhancement of death due to the persistence of such infections those cannot be treated with the conventional drugs causing a global health crisis. Hence, mitigation of this problem is of utmost importance to save lives of human beings and animals. This has forced to find out some alternate way on an urgent basis for risk management including adoption of stringent guidelines for surveillance and monitoring of these industries and development of policies are warranted to develop policies on checking antibiotic pollution as a “One Health Approach”.

Current practices, challenges and new advances in the collection and use of food composition data for Africa

High-quality food composition data are indispensable for improved decision-making in food security, health policy formulation, food labeling, diet formulation, agricultural policymaking, nutrition research, and many other nutrition-related activities. The optimisation of dietary patterns is a powerful tool to reduce the impact of malnutrition on a population’s health and well-being. Many countries in resource-poor settings lack a framework for developing and managing food composition data appropriate for these purposes. In the article, an overview of available food composition tables in Africa and the origin, use and limitations of theses tables are discussed. It is important that those working on any nutrition-related activity for resource-poor settings understand the limitations of current food composition data. Production of high-quality data requires the harmonization and adoption of international standards and guidelines across Africa. Moreover, continuity in the production, compilation and management of high-quality food composition data is challenged by suboptimal capacity building in terms of organizational, institutional and legal framework development. In this perspective article, the authors deliberate on challenges with a focus on Africa, while discussing new advances in food composition activities. Opportunities (such as the Internet of Things (IoT), wearable devices, natural language processing (NLP) and other machine learning techniques) to improve existing resources must be more actively explored and supported.