Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.

Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological, and pharmaceutical data to simulate and predict drug behavior in vivo. Effective utilization of PBBM requires a consistent approach to model development, verification, validation, and application. Currently, only one country has a draft guidance document for PBBM, whereas other major regulatory authorities have had limited experience with the review of PBBM. To address this gap, industry submitted confidential PBBM case studies to be reviewed by the regulatory agencies; software companies committed to training. PBBM cases were independently and collaboratively discussed by regulators, and academic colleagues participated in some of the discussions. Successful bioequivalence "safe space" industry case examples are also presented. Overall, six regulatory agencies were involved in the case study exercises, including ANVISA, FDA, Health Canada, MHRA, PMDA, and EMA (experts from Belgium, Germany, Norway, Portugal, Spain, and Sweden), and we believe this is the first time such a collaboration has taken place. The outcomes were presented at this workshop, together with a participant survey on the utility and experience with PBBM submissions, to discuss the best scientific practices for developing, validating, and applying PBBMs. The PBBM case studies enabled industry to receive constructive feedback from global regulators and highlighted clear direction for future PBBM submissions for regulatory consideration.

Barriers to the quality delivery of seasonal malaria chemoprevention in Chad and Burkina Faso: a qualitative exploration of caregivers and community distributors' perspectives.

BACKGROUND: Recommended since 2012 by the World Health Organization (WHO), seasonal malaria chemoprevention (SMC) is a community-based intervention to prevent malaria in children in African regions where malaria transmission follows a seasonal pattern. Following the publication of consolidated WHO guidelines for malaria, SMC is expected to reach more children in new geographies in future years. Though SMC has been shown to reduce malaria-related morbidity and mortality, there is potential for quality improvement of the intervention implementation. Assisted by ten quality standards from a framework developed by Malaria Consortium, this paper aims to better understand the quality of SMC implementation and identify potential barriers to quality delivery of SMC. METHODS: A qualitative thematic analysis on data collected after the annual SMC rounds implemented in Burkina Faso and Chad in 2019 was conducted. Sixteen focus group discussions conducted with caregivers and community distributors were analysed. Three selected quality standards for SMC delivery; planning and enumeration; community engagement; and administration of SMC medicines provided overarching quality themes under which subthemes were identified. RESULTS: Eight subthemes relating to the three quality standards were identified. Although SMC was well accepted by communities in both settings, common barriers to the quality delivery of SMC were identified including difficulty ensuring adherence to the SMC administration protocol; difficulties reaching mobile populations; concerns around adverse drug reactions; rumours, and concerns about SMC safety; and community distributors' working conditions. Context-specific barriers included: the suboptimal timeliness of the SMC round in Burkina Faso, and the lack of involvement of female caregivers in mobilization activities in Chad. CONCLUSION: In the context of increased adoption of SMC, this paper provides relevant insights and recommendations for the improved implementation of SMC programmes. These include the integration of strategies addressing communities' concerns around adverse drug reactions, gender-specific mobilization strategies, and attention to community distributors' working conditions. It also highlights the importance and utility of further, robust research on the quality of SMC delivery.

RéSUMé EN FRANçAIS: BACKGROUND: Recommandée depuis 2012 par l'Organisation mondiale de la santé (OMS), la chimioprévention du paludisme saisonnier (CPS) est une intervention communautaire visant à prévenir le paludisme chez les enfants dans les régions d'Afrique où la transmission du paludisme suit un schéma saisonnier. Suite à la publication des lignes directrices consolidées de l'OMS sur le paludisme, la CPS devrait toucher davantage d'enfants dans de nouvelles zones géographiques dans les années à venir. Bien qu'il ait été démontré que la CPS réduisait la morbidité et la mortalité liées au paludisme, il y a du potentiel pour améliorer la qualité de l'implémentation l'intervention. En s'appuyant sur un cadre de normes de qualité de la CPS développé par le Malaria Consortium, cette publication vise à mieux comprendre la qualité de la mise en œuvre de la CPS et à identifier les obstacles potentiels à la qualité de la mise en œuvre de la CPS. METHODS: Une étude qualitative basée sur l'analyse secondaire des données collectées après les tournées annuelles du SMC mises en œuvre au Burkina Faso et au Tchad en 2019 a été menée. Une analyse thématique de 16 discussions de groupe menées avec des parents/tuteurs et des distributeurs communautaires a été faite. Trois des éléments clés du cadre des normes de qualité pour le déploiement de la CPS ont fourni les thèmes de qualité principaux sous lesquels les sous-thèmes identifiés ont été placés. RéSULTATS: Huit sous-thèmes relatifs aux normes de qualité ; la planification, la sensibilisation et l'engagement des communautés ainsi que l'administration des médicaments de la CPS ont été identifiés. Bien que la CPS ait été bien acceptée par les communautés dans les deux contextes, des obstacles communs à la qualité du déploiement de la CPS ont été identifiés, notamment : la difficulté d'assurer le respect du protocole d'administration de la CPS; atteindre les populations mobiles ; les préoccupations concernant les effets indésirables des médicaments ; les rumeurs et les préoccupations concernant le SMC; et les conditions de travail des distributeurs communautaires. D'autres barrières spécifiques au contexte de déploiement ont été identifiées, telles que le choix sous-optimal de la période de déploiement au Burkina Faso ou le manque d'implication des mères/tutrices dans les activités de mobilisation au Tchad. CONCLUSION: Dans le contexte de l'adoption croissante de la CPS, cette publication fournit des informations et des recommandations pertinentes pour l'amélioration de la mise en œuvre des programmes de CMS, telles que l'intégration de stratégies répondant aux préoccupations des communautés concernant les effets indésirables des médicaments, les stratégies de mobilisation spécifiques au genre, et/ou l'attention portée aux conditions de travail des distributeurs communautaires. Cette publication souligne également l'importance et l'utilité des recherches en cours sur la qualité du déploiement de la CPS.

RESUMO EM PORTUGUêS: INTRODUçãO: Recomendada desde 2012 pela Organização Mundial de Saúde (OMS), a quimioprevenção sazonal do paludismo (SMC) é uma intervenção de base comunitária para prevenir o paludismo em crianças em zonas da África onde a transmissão do paludismo segue um padrão sazonal. Após a publicação das diretrizes consolidadas da OMS sobre o paludismo, espera-se que a SMC chegue a mais crianças em novas zonas geográficas nos próximos anos. Embora se tenha demonstrado que a SMC reduz a morbilidade e a mortalidade causadas pelo paludismo, há potencial para melhorar a qualidade da implementação da intervenção. Com ajuda dum quadro de padrões de qualidade para a SMC desenvolvido pelo Malaria Consortium, a presente publicação visa compreender melhor a qualidade da implementação da SMC e identificar potenciais barreiras à qualidade da implementação da SMC. MéTODOS: Foi realizado um estudo qualitativo baseado na análise secundária dos dados recolhidos após as rondas anuais da SMC implementadas no Burkina Faso e no Chade em 2019. Foi efectuado uma análise temática de 16 discussões de grupos focais realizadas com cuidadores e distribuidores comunitários. Tres padrões do quadro de normas de qualidade para a implementação da SMC forneceu os principais temas de qualidade sob os quais os subtemas identificados foram colocados. RESULTADOS: Foram identificados oito sub-temas relacionados com padrões de qualidade; planeamento; sensibilização e envolvimento da comunidade; e administração de drogas da SMC. Embora a SMC tenha sido bem aceita pelas comunidades em ambos os contextos, foram identificadas barreiras comuns à implementação duma SMC de qualidade, incluindo: a dificuldade de assegurar o cumprimento do protocolo de administração da SMC; atingir populações móveis; preocupações com reacções adversas aos medicamentos; rumores e preocupações com a SMC; e as condições de trabalho dos distribuidores comunitários. Foram identificados outros obstáculos específicos ao contexto de implantação, tais como a escolha subaproveitada do período de implantação no Burkina Faso ou a falta de envolvimento das cuidadoras femininas nas actividades de mobilização no Chade. CONCLUSãO: No contexto do aumento da adopção da SMC, esta publicação fornece informações e recomendações relevantes para melhorar a implementação de programas de SMC, tais como estratégias integradoras que abordam as preocupações da comunidade sobre reacções adversas aos medicamentos, estratégias de mobilização específicas de género, e/ou atenção às condições de trabalho dos distribuidores comunitários. Salienta igualmente a importância e a utilidade das investigaçãos em curso sobre a qualidade da implementação da SMC.

Quality parameters for the medicinal plant Drosera rotundifolia L.: A new approach with established techniques.

Monographs of the European Pharmacopoeia (Ph. Eur.) are the basis for quality control of medicinal plants and therefore important to ensure the consistency, quality, safety, and efficacy of phytopharmaceuticals. The traditional medicinal plant sundew (Drosera sp.) has disappeared from therapy due to nature conservation, but can now be cultivated sustainably on rewetted peatland. However, currently there is no valid Ph. Eur. monograph for the quality control of Droserae herba. In this study, sundew material from different species and sources was investigated with the aim of developing quality control methods based on the Ph. Eur. and defining a uniform quality standard for Droserae herba. It was possible to distinguish between sundew species of different quality, using macroscopic, microscopic, and chromatographic methods. Special emphasis was laid on the content of flavonoids and naphthoquinones as important quality parameters as their content differed between the sundew species. The differences in content and toxicity result in the recommendation that only round-leaved sundew (Drosera rotundifolia L.) should be used as a medicinal plant for the production of phytopharmaceuticals in the future.

Applying water quality standards to pollution from diffuse sources.

Water quality standards are instrumental in evaluating the status of water bodies, and in providing protective and restorative endpoints. To date, much of the infrastructure used to implement water quality standards has been directed towards remediating and managing pollution from point source discharges. However, pollution from diffuse sources is the leading cause of water quality impairment, especially by nutrients. Although the effects of nutrient enrichment on streams is well studied, and ecological thresholds identified, those thresholds have not been widely adopted as standards primarily because they are not attainable by point sources. Clearly, a framework for adopting and applying standards to manage pollution from diffuse sources needs to be decoupled from those intended for point sources. This paper argues for a relatively unstructured distributional approach to predict how ecological responses might shift in response to management of diffuse sources. The approach calls for first developing a deterministic model of stressor and response variables, followed by a reformulation as a Bayesian model. In the case here, a structural equation model was developed that linked nutrient enrichment, habitat quality, and chloride and manganese concentrations to an index of macroinvertebrate quality. Results from the Bayesian representation suggest that in landscapes where the drainage network has been highly modified for agricultural production, reduction in total phosphorus alone is expected to have a modest (but non-trivial) effect on macroinvertebrate condition, shifting the distribution of scores up by 1 point. The addition of habitat restoration is likely to shift the distribution upwards by 4 points, an effect size observed in Ohio, USA from other large-scale restoration efforts.

Temporal variations in micropollutant inlet concentrations matter when planning the design and compliance assessment of stormwater control measures.

Stormwater Control Measures (SCMs) contribute to reducing micropollutant emissions from separate sewer systems. SCM planning and design are often performed by looking at the hydrological performance. Assessment of pollutant removal and the ability to comply with discharge concentration limits is often simplified due to a lack of data and limited monitoring resources. This study analyses the impact of using different time resolutions of input stormwater concentrations when assessing the compliance of SCMs against water quality standards. The behaviour of three indicator micropollutants (MP - Copper, Diuron, Benzo[a]pyrene) was assessed in four SCM archetypes, which were defined to represent typical SCM removal processes. High resolution MP data were extrapolated by using high resolution (2 min) measurements of TSS over a long period (343 events). The compliance assessment showed that high resolution input concentrations can result in a different level of compliance with water quality standards, especially when discharged concentrations are close to the limit values. This study underlines the importance of considering the high temporal variability of stormwater micropollutants when planning and designing SCMs to identify the most effective solutions for stormwater pollution management and to ensure a thorough consideration of all the environmental implications.

Pancreas units within gastroenterology departments. Organizational and operational standards for a patient-centered service. / Las unidades de páncreas en los servicios de aparato digestivo. Estándares de organización y funcionamiento para un servicio centrado en el paciente.

The Asociación Española de Pancreatología (AESPANC), Asociación Española de Gastroenterología (AEG), and Sociedad Española de Patología Digestiva (SEPD) have developed a consensus document on the standards and recommendations they consider essential for the organization of pancreas units (PUs) within gastroenterology services (GSs) in order to conduct their activities in an efficient, high-quality manner. The consensus document defines PUs and lays down standards relating to their organization, structure, service portfolio, processes, and teaching and research activities. Standards have been categorized as mandatory (requirements to be met to qualify for certification by the scientific societies responsible for the standards) or recommendations. Standards should be updated at most within five years based on the experience gained in Spanish PUs and the advance of knowledge regarding pancreas disease. Development of health outcome indicators, including patient-reported outcome measures (PROMs), is considered a relevant challenge, as is evidence on the association of PU structure and activity standards with health outcomes.

Characterization of Prototype Gummy Formulations Provides Insight into Setting Quality Standards.

Gummy formulations are considered suitable alternatives to traditional oral dosage forms like tablets and capsules due to their merits that include chewability, softness/flexibility, improved drug release, administration without water, appealing organoleptic properties, better patient compliance, easy preparation and usefulness for persons of different ages (e.g. children). Though there is increasing interest in gummy formulations containing drugs, measurable parameters, and specification limits for evaluating their quality are scarce. Quality check forms an essential part of the pharmaceutical development process because drug products must be distributed as consistently stable, safe, and therapeutically effective entities. Consequently, some quality parameters that could contribute to the overall performance of typical gummy formulations were investigated employing six brands of non-medicinal gummies as specimens. Accordingly, key physicochemical and micromechanical characteristics namely adhesiveness (0.009 - 0.028 mJ), adhesive force (0.009 - 0.055 N), chewiness (2.780 - 6.753 N), cohesiveness (0.910 - 0.990), hardness (2.984 - 7.453 N), springiness (0.960 - 1.000), and resilience (0.388 - 0.572), matrix firmness - compression load (2.653 - 6.753 N) and work done (3.288 - 6.829 mJ), rupture (5.315 - 29.016 N), moisture content (< 5%), weight uniformity (< 2.5 g; < 7.5% deviation), and intraoral dissolution pH (≥ 3.5 ≤ 6.8) were quantified to identify measures that may potentially function as specification limits and serve as prospective reference points for evaluating the quality of gummy formulations. Findings from this work contribute to ongoing efforts to standardize the quality control strategies for gummy formulations, particularly those intended for oral drug delivery.

[Establishment and Optimization of Quality Standards for the Traditional Tibetan Medicine Preparation of Liuwei Nengxiao Pills]. / è—è¯å ­å‘³èƒ½æ¶ˆä¸¸è´¨é‡æ ‡å‡†çš„å»ºç«‹ä¸Žä¼˜åŒ–.

Objective: To establish quality standards for Liuwei Nengxiao pills, to optimize the quality control method, and to provide references for the quality control of Liuwei Nengxiao pills. Methods: Chebula, dried ginger, and Tibetan liqueur root in Liuwei Nengxiao pills of different batch numbers were analyzed by thin layer chromatography (TLC). Then, the content of chrysophanol in the preparation was determined by high performance liquid chromatography (HPLC). Furthermore, a series of methodological validation, including the investigation of the linear relationship, precision, stability, and reproducibility and sample recovery test, were performed to verify the reliability of the results. Results: The TLC identification method was easy to perform and demonstrated high specificity, clear spots, and good separation effect. In addition, the negative controls showed no interference. The HPLC method showed high accuracy. The results of methodological validation showed that the peak area of chrysophanol had a good linear relationship (r2=1.0) in the range of 0.06-0.80 µg, presenting good precision (with the relative standard deviation being lower than 2.0%), good stability and reproducibility (with the relative standard deviation being lower than 1.0%), and an average recovery rate of 100.8%. Conclusion: TLC and HPLC are easy to perform, showing high accuracy and reproducibility. The quality standards established are scientific, reasonable, stable, and feasible, providing references for the quality control of Liuwei Nengxiao pills.

Impact of Quality Standards on Stroke Management and Outcome Requires Appropriately Designed Studies.

How to cite this article: Mehri S, Finsterer J. Impact of Quality Standards on Stroke Management and Outcome Requires Appropriately Designed Studies. Indian J Crit Care Med 2024;28(4):406-407.

Quality standards for the care of people with giant cell arteritis in secondary care.

OBJECTIVE: GCA is the commonest primary systemic vasculitis in adults, with significant health economic costs and societal burden. There is wide variation in access to secondary care GCA services, with 34% of hospitals in England not having any formal clinical pathway. Quality standards provide levers for change to improve services. METHODS: The multidisciplinary steering committee were asked to anonymously put forward up to five aspects of service essential for best practice. Responses were qualitatively analysed to identify common themes, subsequently condensed into domain headings, and ranked in order of importance. Quality standards and metrics for each domain were drafted, requiring a minimum 75% agreement. RESULTS: 13 themes were identified from the initial suggestions. Nine quality standards with auditable metrics were developed from the top 10 themes. Patient Access, glucocorticoid use, pathways, ultrasonography, temporal artery biopsy, PET scan access, rheumatology/ophthalmology expertise, education, multidisciplinary working have all been covered in these quality standards. Access to care is a strand that has run through each of the developed standards. An audit tool was developed as part of this exercise. CONCLUSION: These are the first consensus auditable quality standards developed by clinicians from rheumatology and ophthalmology, nursing representatives and involvement of a patient charity. We hope that these standards will be adopted by commissioning bodies to provide levers for change from the improvement of patient care of individuals with GCA.

Enabling national improvement in quality of care for renal colic.

OBJECTIVES: To report the results of a clinical audit conducted by the British Association of Urological Surgeons (BAUS) of ureteric stone care pathways, with results reported with reference to national quality standards. PATIENTS AND METHODS: The BAUS conducted a clinical audit of all patients presenting as an emergency to 107 hospitals in England during November 2020 with ureteric stones. All patients were followed up until 31 March 2021 and the inpatient and outpatient management received was recorded. RESULTS: Data for 2192 patients across 117 units were submitted. The median (interquartile range [IQR]) number of patients per unit was 16 (9-27); 70% of patients were male and the median (IQR) patient age was 46 (34-59) years. Initial management was conservative treatment for 70% of patients. Overall, primary shockwave lithotripsy was performed in 34% of patients and primary ureteroscopy in 23% of cases when surgical intervention was required to treat the stone. However, 40% of patients in whom active intervention was appropriate underwent placement of a temporizing ureteric stent rather than undergo definitive surgical intervention at the outset. Female patients were less likely to have a computed tomography (CT) scan of the kidneys, ureters and bladder performed within 24 h of presentation (13% vs 7.3% for men [chi-squared P = 0.01]) and to be given correct analgesia (66% vs 73% for men [chi-squared P = 0.03]). Patients aged 60 years or older were also significantly less likely to be offered nonsteroidal anti-inflammatory drug analgesia appropriately. In total, 87% of patients had their calcium measured within the last 2 years and 73% of patients had evidence of being offered stone prevention diet and fluid advice. CONCLUSIONS: The audit demonstrates that the National Institute of Health and Care Excellence Quality Standards are both measurable and achievable. However, there was considerable variation in the delivery of these standards, including with regard to sex and age, highlighting inequalities for patient care across the UK.

Towards a better consideration of endocrine disruption within the technical guidance for deriving environmental quality standards.

Endocrine-disrupting chemicals (EDCs) are a reason for growing concern because of their substantial and long-lasting deleterious effects on human health and wildlife populations. These include direct effects on aquatic organisms and may be a concern to species feeding on the aquatic food chains and water, including humans. In the European Community, the dedicated legislative tools to protect the aquatic environment and human health from contaminants released to surface waters is the Water Framework Directive (WFD). The achievement of protection goals is assessed through the comparison of concentrations measured in the media and thresholds of no effect called Environmental Quality Standards (EQSs). As EDCs are explicitly mentioned in the WFD, an analysis of the state of the art was undertaken on how far and how consistently ED properties were considered in the derivation of EQS values. Our results reveal substantial heterogeneity according to substance and that among substances with ED evidences, EQSs have been derived without considering ED properties for 70% of them. A methodology to better consider endocrine disrupting properties is proposed and includes a logical and systematic approach to derive EQSs with a proposal to specify additional assessment factors based on the specific hazard and potential uncertainty.

Hospital accreditation: an umbrella review.

Hospital accreditation is an established quality improvement intervention. Despite a growing body of research, the evidence of effect remains contested. This umbrella review synthesizes reviews that examine the impacts of hospital accreditation with regard to health-care quality, highlighting research trends and knowledge gaps. Terms specific to the population: 'hospital' and the intervention: 'accreditation' were used to search seven databases: CINAHL (via EBSCOhost), Embase, Medline (via EBSCOhost), PubMed, Scopus, the Cochrane Database of Systematic Reviews, and the Joanna Briggs Institute (JBI) EBP Database (via Ovid). 2545 references were exported to endnote. After completing a systematic screening process and chain-referencing, 33 reviews were included. Following quality assessment and data extraction, key findings were thematically grouped into the seven health-care quality dimensions. Hospital accreditation has a range of associations with health system and organizational outcomes. Effectiveness, efficiency, patient-centredness, and safety were the most researched quality dimensions. Access, equity, and timeliness were examined in only three reviews. Barriers to robust original studies were reported to have impeded conclusive evidence. The body of research was largely atheoretical, incapable of precisely explaining how or why hospital accreditation may actually influence quality improvement. The impact of hospital accreditation remains poorly understood. Future research should control for all possible variables. Research and accreditation program development should integrate concepts of implementation and behavioural science to investigate the mechanisms through which hospital accreditation may enable quality improvement.

Quality Assurance Standards for Outreach Cleft Lip and Cleft Palate Repair Programs in Low-Resource Settings.

BACKGROUND: Comprehensive cleft care is a multidisciplinary team endeavor. While untreated craniofacial conditions have multiple undue repercussions, cleft care in outreach settings can be fraught with significant perioperative morbidity risks. AIM: Propose updated quality assurance standards addressing logistic and operational considerations essential for the delivery of safe and effective cleft lip and /or palate (CL/P) care in low and middle-income countries (LMICs) settings. METHODS: Based on American Cleft Palate-Craniofacial Association (ACPA) quality standards, published literature, published protocols by Global Smile Foundation (GSF), and the senior author's three-decade experience, updated standards for outreach cleft care were synthesized. RESULTS: Ten axes for safe, effective, and sustainable cleft lip and palate care delivery in underserved settings were generated: 1) site assessment, 2) establishment of community partnerships, 3) team composition and credentialing, 4) team training and mission preparation, 5) implementation of quality assurance guidelines, operative safety checklists, and emergency response protocols, 6) immediate and long-term postoperative care, 7) medical record keeping, 8) outcomes evaluation, 9) education, and 10) capacity building and sustainability. Subsequent analysis further characterized essential components of each of those ten axes to delineate experience derived and evidence-based recommendations. DISCUSSION: Quality assurance guidelines are essential for the safe delivery of comprehensive cleft care to patients with CL/P in any setting. Properly designed surgical outreach programs relying on honest community partnerships can be effectively used as vehicles for local capacity building and the establishment of sustainable cleft care ecosystems.

Air pollution trends and exceedances: ozone and particulate matter outlook in Brazilian highly urbanized zones.

In Brazil, scarce air quality data hinders air pollutant chemical understanding and policy decisions regarding public health and environmental impacts. From this perspective, our study assessed the O3, PM2.5, and PM10 yearly and seasonal trends and also the WHO Air Quality Guidelines 2021 exceedance trends at 40 air quality stations located in four highly urbanized zones in Brazil (Belo Horizonte, São Paulo, Rio de Janeiro, and Espírito Santo) from early 1990s up to 2019. We applied the Mann-Kendall test aligned with Sen's Slope estimator to assess the trends and the Cox-Stuart test to verify the WHO AQG 2021 exceedances trends. Our findings pointed out that the current national legislation is outdated when compared to WHO AQG 2021 values, leading to multiple exceedances episodes. We also found out that 62% of São Paulo's stations presented O3 increasing trends, while in Rio de Janeiro 85.7% presented decreasing trends. The Cox-Stuart test pointed out that PM2.5 exceedance trends showcase positive values, and most of the significative values are located in São Paulo stations. Therefore, we endorse that the national legislation needs to be updated meanwhile the air monitoring network needs to expand its coverage.

Quality Standard for Rehabilitation of Young Deaf Children Receiving Cochlear Implants.

Background and objectives: More and more children with severe-to-profound hearing loss are receiving cochlear implants (CIs) at an early age to improve their hearing and listening abilities, speech recognition, speech intelligibility, and other aspects of spoken language development. Despite this, the rehabilitation outcomes can be very heterogeneous in this population, not only because of issues related to surgery and fitting or the specific characteristics of the child with his/her additional disabilities but also because of huge differences in the quality of the support and rehabilitation offered by the therapist and the family. These quality standards for the rehabilitation of young deaf children receiving CIs are developed within the European KA202 Erasmus+ project "VOICE"-vocational education and training for speech and language therapists and parents for the rehabilitation of children with CIs, Ref. No.: 2020-1-RO01-KA202-080059. Material and methods: To develop these quality standards, we used the input from the face-to-face interviews of 11 local rehabilitation experts in CIs from the four partner countries of the project and the outcomes of the bibliographic analysis of 848 publications retrieved from six databases: Pub Med, Psych Info, CINAHL, Scopus, Eric, and Cochrane. Based on all this information, we created a first set of 32 quality standards over four domains: general, fitting, rehabilitation, and for professionals. Further on, the Delphi method was used by 18 international rehabilitation experts to discuss and agree on these standards. Results: The results from the literature analysis and the interviews show us that more than 90% of the consulted international experts agreed on 29 quality standards. They focus on different aspects of rehabilitation: the multidisciplinary team, their expertise and knowledge, important rehabilitation topics to focus on, and programming issues related to rehabilitation. Conclusions: These quality standards aim to optimize the activity of speech rehabilitation specialists so that they reach the optimal level of expertise. Also presented is the necessary equipment for the IC team to carry out the rehabilitation sessions in good conditions. This set of quality standards can be useful to ensure the appropriate postoperative care of these children. As a result, the rehabilitation process will be more relaxed, and therapists will have the opportunity to focus more on the specific needs of each child, with the provision of quality services, which will result in better results. This theme is particularly complex and dependent on multifactorial aspects of medicine, education, speech therapy, social work, and psychology that are very intricate and interdependent.

Prospect of China's ambient air quality standards.

Ambient air quality standards are the core strategic goal of ambient air quality management. Countries worldwide have given importance to research on the development of ambient air quality standards. To understand the history of the development of China's ambient air quality standards, this study analyzed the background associated with all previous formulations and revisions of the standards, classification of functional areas, standard grading, pollutants, and evolution of the standard limits over the past 40 years. The results show that since the initial release of the "Ambient Air Quality Standard" by China in 1982, it has been supplemented once, revised twice, and modified twice. The first ambient air quality standard specified the standard limits of six pollutants commonly found in ambient air. With the development of ambient air quality management, the number of pollutants has increased to ten. Since the release of the "Ambient Air Quality Standards" in 2012, the ambient air quality in China has significantly improved. However, the proportion of cities meeting these standards is still low. At present, China is suitably positioned to make the standards associated with 24 hr SO2 concentrations more stringent such that it meets the values defined in the World Health Organization (WHO) interim target-2 and the WHO air quality guideline (AQG). We further suggested that the SO2 standard should be revised promptly. Simultaneously, regions with a relatively high proportion of cities meeting the standard are encouraged to introduce more stringent interim target limits in due course to manage the local ambient air quality.

Riparian vegetation shade restoration and loss effects on recent and future stream temperatures.

River temperatures are expected to increase this century harming species requiring cold-water habitat unless restoration activities protect or improve habitat availability. Local shading by riparian vegetation can cool water temperatures, but uncertainty exists over the scaling of this local effect to larger spatial extents. We evaluate this issue using a regional spatial stream network temperature model with covariates representing shade effects to predict mean August stream temperatures across 78,195 km of tributaries flowing into the Columbia River in the northwestern US. We evaluate nine scenarios predicting stream temperatures for three riparian shade conditions (current, restored, and no riparian vegetation) within three different climate periods (2000s, 2040s, and 2080s). Results suggest riparian shade restoration (2000s climate) could decrease mean August stream temperatures by 0.62°C across the study network. Under the same restored shade conditions, temperature predictions for tributaries at their confluence with the Columbia River range from 0.02-2.08°C cooler than under current shade conditions. The climate warming effect predicted for the 2040s and 2080s, however, is greater than the cooling effect from restoring riparian shade. Streams less than 10m bankfull width cooled more frequently with riparian shade restoration. In Oregon, the proportion of fish habitat for salmon and trout rearing and migration that meet temperature numeric water quality criteria could be increased by 20% under restored shade conditions although net habitat declines may still occur in the future. We conclude riparian vegetation restoration could partially mitigate future warming and help maintain cold-water habitats that function as thermal refuges if implemented strategically.

Environmental quality standards for agricultural land in China: What should be improved on derivation methodology?

Soil pollution has caused increasingly widespread attention in China. The environmental risk threshold of pollutants is a yardstick to measure soil environmental quality. For decades, plenty of research on soil environmental quality standards (SEQSs) has been carried out, providing scientific basis for the investigation and supervision of soil environmental quality. This paper summaries the development of SEQSs in China, the corresponding influencing factors and methodology of SEQSs derivation. In the current version of SEQSs (GB15618-2018), the thresholds of soil pollutants are derived by the methods of environmental risk assessment, which are more methodologically scientific than geochemical method and ecological effect method used in the previous version (GB15618-1995). Abundant toxicology data on related species is required for risk assessment of soil pollution using extrapolation; however, basic toxicological data is insufficient and few valid data is available at present. Besides, the inadequate consideration on influencing factors for the derivation of soil pollutant threshold would affect the scientificity and rationality of SEQSs, such as biotic factors (species type, test endpoint etc.) and abiotic factors (aging effect, leaching effect, synergistic or antagonistic effects of elements etc.). These problems should be paid close attention in future research on soil environmental quality standards. The contents summarized in this review may provide reference for decision-making on supervision of soil environmental quality and point out important directions for future studies.

[Development of quality standards for patients with rheumatoid arthritis for use in Germany]. / Entwicklung von Qualitätsstandards für die Versorgung von Patient*innen mit rheumatoider Arthritis zur Anwendung in Deutschland.

Despite a qualitatively and structurally good care of patients with rheumatoid arthritis (RA) in Germany, there are still potentially amendable deficits in the quality of care. For this reason, the German Society for Rheumatology (DGRh) has therefore decided to ask a group of experts including various stakeholders to develop quality standards (QS) for the care of patients with RA in order to improve the quality of care. The QS are used to determine and quantitatively measure the quality of care, subject to relevance and feasibility. The recently published NICE and ASAS standards and a systematic literature search were used as the basis for development. A total of 8 QS, now published for the first time, were approved with the intention to measure and further optimize the quality of care for patients with RA in Germany.