Practical considerations for spirometry during the COVID-19 outbreak: Literature review and insights.

BACKGROUND: As the Coronavirus disease 2019 (COVID-19) is spreading worldwide, countries are dealing with different phases of the pandemic. Lately, scientific evidence has been growing about the measures for reopening respiratory outpatient services during the COVID-19 pandemic. We aim to summarize the key differences and similarities among recommendations by different national and international organizations. METHODS: We searched on Google and Pubmed for recently published National and International Recommendations/Guidelines/Position Papers from professional organizations and societies, offering a guidance to physicians on how to safely perform pulmonary function testing during COVID-19 pandemic. We also searched for spirometry manufacturers' operational indications. RESULTS: Indications on spirometry were released by the Chinese Task force, the American Thoracic Society, the European Respiratory Society, the Thoracic Society of Australia and New Zealand, the Société de Pneumologie de Langue Française, the Spanish Societies (Sociedad Espanola de Neumologia y Cirugia Toracica, Sociedad Espanola de Alergologia e Inmunologia Clinica, Asociacion de Especialistas en Enfermeria del trabajo, Asociacion de Enfermeria Comunitaria), the Sociedade Portuguesa de Pneumologia, the British Thoracic Society/Association for Respiratory Technology & Physiology, the Irish Thoracic Society, the Sociedad Uruguaya de Neumologia, the Italian Thoracic Society and the Italian Respiratory Society, Cleveland Clinic and Nebraska Medical Center. Detailed technical recommendations were found on manufacturers' websites. We found several similarities across available guidelines for safely resuming pulmonary function services, as well as differences in criteria for selecting eligible patients for which spirometry is deemed essential and advice which was not homogenous on room ventilation precautions. CONCLUSIONS: This study shows a synthesis of national/international guidelines allowing practicing physicians to adapt and shape the way to organize their outpatient services locally. There is generally good agreement on the importance of limiting pulmonary function testing to selected cases only. However, significant differences concerning the subsets of candidate patients, as well as on the management of adequate room ventilation, were observed.

Nota técnica nº 010/2020 ­ SAMU/DAPM/SUE/SES: Recomendações sobre ventilação mecânica e utilização de equipamentos ventiladores pulmonares / Technical note nº 010/2020 - SAMU / DAPM / SUE / SES: Recommendations on mechanical ventilation and use of ventilator equipment

Adoção de medidas preventivas e estabelece recomendações para ventilação mecânica, e utilização de ventiladores pulmonares no SAMU. No serviço há modelos diversos de ventiladores pulmonares, para utilização nos pacientes que necessitam de suporte ventilatório durante os atendimentos e/ou transportes, inclusive pacientes suspeitos ou confirmados para COVID-19.

Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System.

It is important to identify, assess, and address current barriers to implementation of post-approval changes that are intended to ensure continued (uninterrupted) operations and drive innovation and continual improvement in a maximally efficient, agile, and flexible pharmaceutical manufacturing sector. Leveraging the International Conference for Harmonisation Quality Guideline Q10 provides regulatory relief when it comes to addressing changes related to excipients, specifically excipient supplier's name and address changes, which will ensure a sustainable, reliable global supply and the availability of high quality product to patients through the entire commercial lifecycle of a product without extensive regulatory oversight.

Practice Variation in Vena Cava Filter Use Among Trauma Centers in the National Trauma Database.

BACKGROUND: Agreement regarding indications for vena cava filter (VCF) utilization in trauma patients has been in flux since the filter's introduction. As VCF technology and practice guidelines have evolved, the use of VCF in trauma patients has changed. This study examines variation in VCF placement among trauma centers. MATERIALS AND METHODS: A retrospective study was performed using data from the National Trauma Data Bank (2005-2014). Trauma centers were grouped according to whether they placed VCFs during the study period (VCF+/VCF-). A multivariable probit regression model was fit to predict the number of VCFs used among the VCF+ centers (the expected [E] number of VCF per center). The ratio of observed VCF placement (O) to expected VCFs (O:E) was computed and rank ordered to compare interfacility practice variation. RESULTS: In total, 65,482 VCFs were placed by 448 centers. Twenty centers (4.3%) placed no VCFs. The greatest predictors of VCF placement were deep vein thrombosis, spinal cord paralysis, and major procedure. The strongest negative predictor of VCF placement was admission during the year 2014. Among the VCF+ centers, O:E varied by nearly 500%. One hundred fifty centers had an O:E greater than one. One hundred sixty-nine centers had an O:E less than one. CONCLUSIONS: Substantial variation in practice is present in VCF placement. This variation cannot be explained only by the characteristics of the patients treated at these centers but could be also due to conflicting guidelines, changing evidence, decreasing reimbursement rates, or the culture of trauma centers.

Towards a common framework for defining ancillary material quality across the development spectrum.

Ancillary materials (AMs) play a critical role in the manufacture of cell and gene therapies, and best practices for their quality management are the subject of ongoing discussion. Given that the final product cannot be sterilized, AM quality becomes increasingly critical to the clinical advancement of cell and gene therapies. Despite a lack of direct legislative direction regarding AM quality, internationally harmonized guidance is available from several industry-standard bodies that describe the principles and application of a risk-based approach to AM qualification and related supply-chain risk management. According to a best-practice risk-based approach, AMs must be adequately qualified to a degree that reflects the level of risk the material presents to patient safety and the drug product's specification. This general approach can be implemented in different ways, and balancing quality with cost of goods is critical to the cost-effective manufacture of advanced therapy medicinal products. In some cases, it may be preferable or necessary to use AMs that are produced in compliance with current Good Manufacturing Practice. However, developers may be able to suppress manufacturing costs without undermining safety or regulatory compliance in the case that a material presents a lower risk profile. Despite a great deal of attention and interest in the quality of AMs in the cell and gene therapy space, there is still a need for greater harmonization to create a shared understanding of what constitutes a risk-based approach to AM production and sourcing. In this article, we propose a staged approach to AM quality that achieves a balance between the competing demands of risk mitigation and cost of goods containment at the various stages of AM quality development. Our novel, heuristic framework for communication among AM suppliers, users and regulators aims to bring down development and manufacturing costs and lessen the workload around regulatory compliance.

Supply Chains in Healthcare Organizations: Lessons Learned from Recent Shortages.

This paper examines the need for better management of supply chains in healthcare facilities. Recent shortages have highlighted the need for better supply chain systems. The reasons for the shortages are false scarcity, natural disasters, medical lawsuits, production process problems, and group purchasing organizations (GPO). These problems have occurred with increasing frequency. There are three possible solutions available to handle the shortages. First, better use of supply chain management, including multiple suppliers and safety stock. Second, there needs to be better cooperation between suppliers, consumers, and government entities. Finally, healthcare facilities should develop teams of individuals responsible for monitoring critical areas and developing contingency plans.

Factors Influencing Use of Continuous Physiologic Monitors for Hospitalized Pediatric Patients.

OBJECTIVES: Continuous physiologic monitors (CPMs) generate frequent alarms and are used for up to 50% of children who are hospitalized outside of the ICU. Our objective was to assess factors that influence the decision to use CPMs. METHODS: In this qualitative study, we used group-level assessment, a structured method designed to engage diverse stakeholder groups. We recruited clinicians and other staff who work on a 48-bed hospital medicine unit at a freestanding children's hospital. We developed a list of open-ended prompts used to address CPM use on inpatient units. Demographic data were collected from each participant. We conducted 6 sessions to permit maximum participation among all groups, and themes from all sessions were merged and distilled. RESULTS: Participants (n = 78) included nurses (37%), attending physicians (17%), pediatric residents (32%), and unit staff (eg, unit coordinator; 14%). Participants identified several themes. First, there are patient factors (eg, complexity and instability) for which CPMs are useful. Second, participants perceived that alarms have negative effects on families (eg, anxiety and sleep deprivation). Third, CPMs are often used as surrogates for clinical assessments. Fourth, CPM alarms cause anxiety and fatigue for frontline staff. Fifth, the decision to use CPMs should be, but is not often, a team decision. Sixth, and finally, there are issues related to the monitor system's setup that reduces its utility. CONCLUSIONS: Hospital medicine staff identified patient-, staff-, and system-level factors relevant to CPM use for children who were hospitalized. These data will inform the development of system-level interventions to improve CPM use and address high alarm rates.

The Outcomes of a Comprehensive Program for Maintenance of Goldmann Applanation Tonometer.

PRECIS: We checked 190 tonometers every month and repaired faulty ones. Calibration error (CE) frequency reduced from 23% to 0.6% at 1 year. Tonometers needing one or >1 CE repair differed in survival but not in age. PURPOSE: The purpose of this study was to report the outcomes of a comprehensive program to maintain calibration status of the Goldmann applanation tonometer. METHODS: This prospective cohort study was carried out at 2 tertiary eye care referral centers. We included 190 slit-lamp mounted Goldmann applanation tonometers (Model AT 900 C/M). Health care providers (error checking and reporting) and clinical engineers (maintenance) participated. The team carried out CE check once a month, and repair of faulty tonometers, if any, within 24 hours. Failure of tonometer was defined as development of unacceptable CE beyond the third repair. The main outcome measures were the frequency of CE and survival function of the tonometer over 1 year. RESULTS: The median age of the tonometers was 10.7 (range, 0.2 to 25.1) years. The total number of repairs was 86. The proportion (95% confidence interval) of faulty tonometers reduced from 23.1% (17.7, 29.6) in the first month to 0.6% (0.1, 3.3) at 1 year (P<0.01). The median age of the tonometer did not differ between those needing (n=63, 9.4 y) and not needing (n=127, 10.7 y; P=0.24) repair. All tonometers requiring 1 CE repair (n=49, 25.7%) survived until 1 year. The survival of tonometers requiring >1 CE repair (n=14, 7.3%) was 40% at 1 year. CONCLUSIONS: Our in-house program maintained 92.6% tonometers error free. Number of repairs rather than age determined the need for replacement/sending back the tonometer to the manufacturer. Our simple and easy to follow maintenance program has the potential for wide application.

Impact of Nonconcordance With NCCN Guidelines on Resource Utilization, Cost, and Mortality in De Novo Metastatic Breast Cancer.

Background: The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) have directed the care of patients with cancer for >20 years. Payers are implementing guideline-based pathway programs that restrict reimbursement for non-guideline-based care to control costs, yet evidence regarding impact of guidelines on outcomes, including mortality, Medicare costs, and healthcare utilization, is limited. Patients and Methods: This analysis evaluated concordance of first treatment with NCCN Guidelines for women with de novo stage IV metastatic breast cancer (MBC) included within the SEER-Medicare linked database and diagnosed between 2007 and 2013. Cox proportional hazards models were used to evaluate the association between mortality and guideline concordance. Linear mixed-effects and generalized linear models were used to evaluate total cost to Medicare and rates of healthcare utilization by concordance status. Results: We found that 19% of patients (188/988) with de novo MBC received nonconcordant treatment. Patients receiving nonconcordant treatment were more likely to be younger and have hormone receptor-negative and HER2-positive MBC. The most common category of nonconcordant treatment was use of adjuvant regimens in the metastatic setting (40%). Adjusted mortality risk was similar for patients receiving concordant and nonconcordant treatments (hazard ratio [HR], 0.85; 95% confidence limit [CL], 0.69, 1.05). When considering category of nonconcordance, patients receiving adjuvant regimens in the metastatic setting had a decreased risk of mortality (HR, 0.60; 95% CL, 0.43, 0.84). Nonconcordant treatments were associated with $1,867 higher average Medicare costs per month compared with concordant treatments (95% CL, $918, $2,817). Single-agent HER2-targeted therapy was the highest costing category of nonconcordance at $3,008 (95% CL, $1,014, $5,001). Healthcare utilization rates were similar for patients receiving concordant and nonconcordant treatments. Conclusions: Despite a lack of survival benefit, concordant care was associated with lower costs, suggesting potential benefit to increasing standardization of care. These findings may influence policy decisions regarding implementation of pathway programs as health systems transition to value-based models.