Multisource solid waste development of low-carbon ultra-light foamed insulation materials: A feasibility study.

The continuous increase in building energy consumption, and the increasing types and quantities of solid waste have seriously hindered the rapid development of social economy. Therefore, reducing building energy consumption while realizing the recycling of waste has become the mainstream topic of environmental protection construction in the new era. An alkali-activated ultra-light foamed insulation material (AFIM) for building walls was prepared using EPS particles as lightweight aggregates. The effects of EPS dosage, particle size, and gradation on the compressive strength, dry density, thermal conductivity, and volumetric water absorption of AFIM were studied. The results showed that while ensuring good mechanical properties of AFIM, EPS particles can significantly reduce the dry density, thermal conductivity, and volumetric water absorption of AFIM. Excitingly, the optimal thermal conductivity and dry density of AFIM were 0.0408 W/(m·K) and 127.03 kg/m3, respectively. The microscopic morphology results showed that there was good compatibility between EPS particles and AFIM slurry, and the interface transition zone (ITZ) between them was dense and without obvious cracks. In addition, the feasibility of AFIM was evaluated from four aspects: performance, energy consumption, carbon emissions, and life cycle cost (LCC). It was encouraged that the performance of AFIM was comparable to that of traditional insulation materials, and showed significant advantages in energy conservation, emission reduction and economic benefits compared to traditional insulatin materials.

A feasibility assessment of real-world data capabilities for monitoring vaccine safety and effectiveness in China: Human papillomavirus vaccination in the Yinzhou district as a use case.

BACKGROUND: Real-world data (RWD) are increasingly used to generate real-world evidence (RWE) of vaccine safety and effectiveness for regulatory purposes. Assessing feasibility of using RWD sources prior to implementing observational studies is recommended. As a use case, we described the process and findings of a feasibility assessment to identify reliable and relevant data sources for monitoring the safety and effectiveness of the AS04-HPV-16/18 human papillomavirus (HPV) vaccine in China. METHODS: Iterative multi-step process: (1) targeted literature review and data source mapping; (2) expert opinion from national RWD experts; (3) survey to evaluate the identified data source operational infrastructure; and (4) continuous appraisal of published studies using the identified data source. RESULTS: The Yinzhou Regional Health Information Platform (YRHIP) was identified as a data source of main interest, based on its large population coverage, high cervical cancer screening rates, and availability of adult electronic immunization records. Field meetings with national RWD experts confirmed its suitability for post-authorization vaccine studies. Survey results showed that exposure data and relevant safety and effectiveness endpoints were recorded and linkable at the individual level across the platform. Iterative appraisal of emerging evidence from the literature corroborated these findings. CONCLUSIONS: This feasibility assessment indicates that the YRHIP has the capacity to capture demographic, exposure, outcome and other data required to generate RWE on HPV vaccine safety and effectiveness in China. Studies using the YRHIP to monitor the AS04-HPV-16/18 vaccine in routine use building on this feasibility assessment are ongoing.

Scoping review and characteristics of publicly available checklists for assessing clinical trial feasibility.

BACKGROUND: Whether there is sufficient capacity and capability for the successful conduct and delivery of a clinical trial should be assessed by several stakeholders according to transparent and evidence-based criteria during trial planning. For this openly shared, user-tested, and validated tools are necessary. Therefore, we systematically examined the public availability and content of checklists which assess the study-level feasibility in the planning phase of clinical trials. METHODS: In our scoping review we systematically searched Medline, EMBASE, and Google (last search, June 2021). We included all publicly available checklists or tools that assessed study level feasibility of clinical trials, examined their content, and checked whether they were user-tested or validated in any form. Data was analysed and synthesised using conventional content analysis. RESULTS: A total of 10 publicly available checklists from five countries were identified. The checklists included 48 distinct items that were classified according to the following seven different domains of clinical trial feasibility: regulation, review and oversight; participant recruitment; space, material and equipment; financial resources; trial team resources; trial management; and pilot or feasibility studies. None of the available checklists appeared to be user-tested or validated. CONCLUSIONS: Although a number of publicly available checklists to assess the feasibility of clinical trials exist, their reliability and usefulness remain unclear. Openly shared, user-tested, and validated feasibility assessment tools for a better planning of clinical trials are lacking.

Assessment of the feasibility of developing a clinical pathway using a clinical order log.

A clinical pathway (CP) is a tool for effectively managing a care process. There are several research efforts on developing clinical pathways (CPs) in the process mining domain. However, the nature of the data affects data analysis results, and patient clinical variability makes it challenging to develop CPs. Thus, it is crucial to determine candidate care processes that can be standardized as CPs before applying process mining techniques. This paper proposed a method for assessing CP feasibility regarding clinical complexity using clinical order logs from electronic health records. The proposed method consists of data preparation, activity & trace homogeneity evaluations, and process inspection using process mining. Each step consists of metrics to measure the homogeneity of processes and a visualization method to demonstrate the diversity of processes based on the log. The case study was conducted with five surgical groups of patients from a tertiary hospital in South Korea to validate the proposed method. The five groups of patients were successfully assessed. In addition, the visualization methods helped clinical experts grasp the diversity of care processes.

Linking electronic health data in pharmacoepidemiology: Appropriateness and feasibility.

PURPOSE: To provide guidance on data linkage appropriateness and feasibility to plan purposeful and sustainable new linkages that advance pharmacoepidemiology and healthcare research. Planning a new data linkage requires careful evaluation to weigh the resources required with the potential overall benefits. METHODS: In response to an International Society for Pharmacoepidemiology (ISPE) call for manuscripts, a working group comprised of members from academic, industry, and government determined priority content areas; appropriateness and feasibility of data linkage was selected. Within this topic, scientific and operational considerations were determined, reviewed, and formulated into key areas, and translated into 12 consensus recommendations. RESULTS: Guidance for feasibility assessment was categorized into five key areas: (1) research objectives and justification; (2) data quality and completeness; (3) the linkage process; (4) data ownership and governance; and (5) overall value added by linkage. Within these key areas, recommendations to consider prior to initiation were developed to evaluate suitability of the linkage to meet research objectives, assess source data completeness and population coverage, and ensure well-defined data governance standards and protections. When creating novel linked datasets, researchers must assess the feasibility of both scientific (data quality and linkage methods) and operational (access, data use and transfer, governance, and cost) aspects. CONCLUSIONS: The data linkage feasibility assessment considerations outlined can be used as a guide when designing sustainable linked data resources to generate actionable evidence in healthcare research. These recommendations were constructed for wide applicability and can be adapted depending on the geographic, structural, and data components of the linkage.

Adapting and implementing training, guidelines and treatment cards to improve primary care-based hypertension and diabetes management in a fragile context: results of a feasibility study in Sierra Leone.

BACKGROUND: Sierra Leone, a fragile country, is facing an increasingly significant burden of non-communicable diseases (NCDs). Facilitated by an international partnership, a project was developed to adapt and pilot desktop guidelines and other clinical support tools to strengthen primary care-based hypertension and diabetes diagnosis and management in Bombali district, Sierra Leone between 2018 and 2019. This study assesses the feasibility of the project through analysis of the processes of intervention adaptation and development, delivery of training and implementation of a care improvement package and preliminary outcomes of the intervention. METHODS: A mixed-method approach was used for the assessment, including 51 semi-structured interviews, review of routine treatment cards (retrieved for newly registered hypertensive and diabetic patients from June 2018 to March 2019 followed up for three months) and mentoring data, and observation of training. Thematic analysis was used for qualitative data and descriptive trend analysis and t-test was used for quantitative data, wherever appropriate. RESULTS: A Technical Working Group, established at district and national level, helped to adapt and develop the context-specific desktop guidelines for clinical management and lifestyle interventions and associated training curriculum and modules for community health officers (CHOs). Following a four-day training of CHOs, focusing on communication skills, diagnosis and management of hypertension and diabetes, and thanks to a CHO-based mentorship strategy, there was observed improvement of NCD knowledge and care processes regarding diagnosis, treatment, lifestyle education and follow up. The intervention significantly improved the average diastolic blood pressure of hypertensive patients (n = 50) three months into treatment (98 mmHg at baseline vs. 86 mmHg in Month 3, P = 0.001). However, health systems barriers typical of fragile settings, such as cost of transport and medication for patients and lack of supply of medications and treatment equipment in facilities, hindered the optimal delivery of care for hypertensive and diabetic patients. CONCLUSION: Our study suggests the potential feasibility of this approach to strengthening primary care delivery of NCDs in fragile contexts. However, the approach needs to be built into routine supervision and pre-service training to be sustained. Key barriers in the health system and at community level also need to be addressed.

Feasibility Assessment of a Fine-Grained Access Control Model on Resource Constrained Sensors.

Upcoming smart scenarios enabled by the Internet of Things (IoT) envision smart objects that provide services that can adapt to user behavior or be managed to achieve greater productivity. In such environments, smart things are inexpensive and, therefore, constrained devices. However, they are also critical components because of the importance of the information that they provide. Given this, strong security is a requirement, but not all security mechanisms in general and access control models in particular are feasible. In this paper, we present the feasibility assessment of an access control model that utilizes a hybrid architecture and a policy language that provides dynamic fine-grained policy enforcement in the sensors, which requires an efficient message exchange protocol called Hidra. This experimental performance assessment includes a prototype implementation, a performance evaluation model, the measurements and related discussions, which demonstrate the feasibility and adequacy of the analyzed access control model.

Importance of feasibility assessments before implementing non-interventional pharmacoepidemiologic studies of vaccines: lessons learned and recommendations for future studies.

PURPOSE: Investigational and marketed vaccines are increasingly evaluated, and manufacturers are required to put in place mechanisms to monitor long-term benefit-risk profiles. However, generating such evidence in real-world settings remains challenging, especially when rare adverse events are assessed. Planning of an appropriate study design is key to conducting a valid study. The aim of this paper is to illustrate how feasibility assessments support the generation of robust pharmacoepidemiological data. METHODS: Following an initiative launched by the International Society for Pharmacoepidemiology in May 2014, a working group including members of the private and public sectors, was formed to assess the value of conducting feasibility assessments as a necessary step before embarking on larger-scale post-licensure studies. Based on five real-life examples of feasibility assessments, lessons learned and recommendations were issued by the working group to support scientific reasoning and decision making when designing pharmacoepidemiologic vaccine studies. RESULTS: The working group developed a toolbox to provide a pragmatic approach to conducting feasibility assessments. The toolbox contains two main components: the scientific feasibility and the operational feasibility. Both components comprise a series of specific questions aimed at overcoming methodological and operational challenges. CONCLUSIONS: A feasibility assessment should be formalized as a necessary step prior to the actual start of any pharmacoepidemiologic study. It should remain a technical evaluation and not a hypothesis testing. The feasibility assessment report may facilitate communication with regulatory agencies toward improving the quality of study protocols and supporting the endorsement of study objectives and methods addressing regulatory commitments. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

Feasibility of "Symptom Discovery," a Longitudinal and Comprehensive Data Collection Tool During COVID-19.

There are few patient- or public-facing tools for longitudinal and comprehensive symptom assessment, especially when faced with an uncharacterized condition such as COVID-19 or a chronic condition in which symptoms have not been adequately specified. To address this need, we developed the Symptom Discovery mobile application and tested its feasibility with the US public early in the COVID-19 pandemic. Although there were challenges, results showed feasibility and acceptance.

Potential data for feasibility assessment and deployment of a 6.7 MW floating solar PV plant in Hatirjheel Lake, Dhaka, Bangladesh.

Floating solar photovoltaic has emerged as a highly sustainable and environmentally friendly solution worldwide from the various clean energy generation technologies. However, the installation of floating solar differs from rooftop or ground-mounted solar due to the significant consideration of the availability of water bodies and suitable climatic conditions. Therefore, conducting a feasibility analysis of the suitable climate is essential for installing a floating solar plant on water bodies. These data are evaluated for the viability of installing a 6.7 MW floating solar power plant on Hatirjheel Lake in Dhaka, Bangladesh. The feasibility analysis incorporated various climatic data, such as temperature, humidity, rainfall, sunshine hours, solar radiation, and windspeed, obtained from Meteonorm 8.1 software and the archive of the Bangladesh Meteorological Department. Besides, this study gathered and analyzed the energy demands of the local grid substation operated by Dhaka Power Distribution Company, to determine the appropriate capacity and architecture of the power plant. The power plant design was conducted using the PVsyst 7.3 software, which determined the necessary equipment quantities, DC energy generation capacity, and the energy injected into the grid in MWh. The study also calculated the Levelized Cost of Energy per kilowatt-hour and the payback period for the system, which indicates the economic viability of installing the system. Furthermore, the acquired dataset possesses significant potential and can be utilized for the establishment of all sorts of solar power plants, including floating solar plants, in any location or body of water within the Dhaka Metropolitan area.

Feasibility assessment of patient-controlled EEG home-monitoring: More results from the HOMEONE study.

OBJECTIVE: The feasibility phase of the HOME (Home-Monitoing and Education) project aims to show the practical feasibility of Electroencephalography (EEG)home-monitoring using a patient-controlled mobile system. Its objective is to assess the potential diagnostic and therapeutic yields of home-monitoring compared to conventional healthcare. METHODS: 16 office-based practitioners chose 97 patients and recorded standard 20-minute EEGs using conventional recorders. After training, the same patients used a patient-controlled mobile dry electrode EEG system in their home environment. The practitioners in charge and two additional raters assessed all recordings. We conducted inter-rater and intra-rater comparisons between the diagnostic findings. RESULTS: 89 patients successfully conducted home-monitoring recordings. The intra-rater comparison results for the diagnostic findings of the conventional recordings and the patient-made recordings show a fair Cohen's kappa value (0.21). Additionally, we documented a change of patient management in 9 cases. CONCLUSIONS: The feasibility of EEG home-monitoring using a patient-controlled device is confirmed. The yield of EEG home-monitoring comprises information that can influence patient management. SIGNIFICANCE: Patient-controlled EEG home-monitoring is feasible as part of routine care for neurological outpatients as its technical efficacy and practical feasibility are shown and significantly positive effects on patient management are evidenced.

Indirect comparisons of siponimod with fingolimod and ofatumumab in multiple sclerosis: assessing the feasibility of propensity score matching analyses.

OBJECTIVE: Head-to-head trials comparing siponimod with fingolimod or ofatumumab in patients with multiple sclerosis (MS) are lacking. Instead, the comparative efficacy of siponimod can be derived from indirect treatment comparisons (ITCs). We assessed the suitability of ITCs leveraging individual patient data from relevant phase III trials across different MS phenotypes. METHODS: One siponimod trial in patients with secondary progressive MS (SPMS), four fingolimod trials (three in relapsing-remitting MS [RRMS], and one in primary progressive MS [PPMS]), and two ofatumumab trials in relapsing MS (RMS) were considered. The suitability of ITCs was evaluated based on trial design, patient eligibility criteria, baseline patient characteristics, placebo response, and outcome definitions for each trial. Analyses deemed feasible were conducted using one-to-one propensity score matching (PSM). RESULTS: An ITC between siponimod in SPMS and either fingolimod in RRMS or ofatumumab in RMS was not feasible because of insufficient overlap in key patient characteristics (e.g. disability level and relapse history) and differences in placebo response. However, a comparison between siponimod in SPMS and fingolimod in PPMS was feasible because of sufficient overlap in eligibility criteria and baseline characteristics. One-to-one PSM demonstrated siponimod was favored relative to fingolimod for time to 6- and 3-month confirmed disability progression though not significantly different (hazard ratio 0.76 [95% confidence interval 0.48-1.20; p-value = .240] and hazard ratio 0.80 [95% confidence interval 0.52-1.22; p-value = .300], respectively). CONCLUSIONS: For trials in MS, clinical phenotype is an important determinant of ITC feasibility. An ITC between siponimod in SPMS and either fingolimod in RRMS or ofatumumab in RMS was not feasible. The only feasible comparison was between siponimod in SPMS and fingolimod in PPMS.

Measuring implementation feasibility of clinical decision support alerts for clinical practice recommendations.

OBJECTIVE: The study sought to describe key features of clinical concepts and data required to implement clinical practice recommendations as clinical decision support (CDS) tools in electronic health record systems and to identify recommendation features that predict feasibility of implementation. MATERIALS AND METHODS: Using semistructured interviews, CDS implementers and clinician subject matter experts from 7 academic medical centers rated the feasibility of implementing 10 American College of Emergency Physicians Choosing Wisely Recommendations as electronic health record-embedded CDS and estimated the need for additional data collection. Ratings were combined with objective features of the guidelines to develop a predictive model for technical implementation feasibility. RESULTS: A linear mixed model showed that the need for new data collection was predictive of lower implementation feasibility. The number of clinical concepts in each recommendation, need for historical data, and ambiguity of clinical concepts were not predictive of implementation feasibility. CONCLUSIONS: The availability of data and need for additional data collection are essential to assess the feasibility of CDS implementation. Authors of practice recommendations and guidelines can enable organizations to more rapidly assess data availability and feasibility of implementation by including operational definitions for required data.

Evaluating the Feasibility of Electronic Health Records and Claims Data Sources for Specific Research Purposes.

Data collected in real-world clinical settings are increasingly being used to evaluate therapeutic options. While in its infancy for research assessing effectiveness, especially comparative effectiveness in the regulatory environment, electronic health records (EHR) and administrative insurance claims data are used extensively by both manufacturers and regulators to evaluate post-marketing safety of products in the real world. The feasibility of using these data for analysis in a research study depends on the specific research question and the availability, quality and relevance of the collected data to address the scientific question. It is unlikely that any specific database could be 'qualified' for use across all research questions, even within a specific therapeutic area, due to dependence of feasibility on the elements of the specific research question. This paper describes considerations for determining whether EHR or claims data can be used for specific research purposes. A new structured approach for assessing the feasibility of these data in research is proposed. The framework builds on and considers whether each element of the PICOTS framework for well-structured research questions is adequately captured to allow for viable reliance on EHR and claims data for that specific scientific question. Practical examples and discussion of the limitations of RWD for research are given along with approaches for interpretation of analyses using RWD.

The impact of clinical heterogeneity on conducting network meta-analyses in transthyretin amyloidosis with polyneuropathy.

Objective: The comparative safety and efficacy of tafamidis, patisiran and inotersen treatments for transthyretin amyloidosis with polyneuropathy (ATTR-PN) has not been evaluated in clinical trials. In the absence of head-to-head evidence, indirect treatment comparisons such as network meta-analyses (NMAs) can be performed to evaluate relative effects of treatments. This study aims to assess the feasibility of conducting an NMA of available therapies for ATTR-PN patients.Methods: Pivotal trials for three approved ATTR-PN treatments, tafamidis (Fx-005), patisiran (APOLLO) and inotersen (NEURO-TTR), were compared in terms of study design, baseline population characteristics, outcome definitions and baseline risk. These assessments of heterogeneity informed the decision to perform Bayesian NMAs.Results: Despite similar study designs, clear differences in eligibility criteria between trials were accompanied by imbalances in baseline population characteristics considered to be plausible effect modifiers, such as disease stage and previous treatment. Of the outcomes assessed, only quality of life and adverse events were similarly reported in all trials. Neuropathy outcomes were not evaluated consistently between trials.Conclusions: An NMA of ATTR-PN treatments was not feasible, given the observed cross-trial heterogeneity. This decision highlights the importance of careful consideration for clinical heterogeneity that may threaten the validity of indirect comparisons.

Feasibility of a Low-Fidelity Pediatric Simulation-Based Continuing Education Curriculum in Rural Alaska.

Introduction Simulation-based continuing education (SBCE) is a widely used tool to improve healthcare workforce performance. Healthcare providers working in geographically remote and resource-limited settings face many challenges, including the development and application of SBCE. Here, we describe the development, trial, and evaluation of an SBCE curriculum in an Alaska Native healthcare system with the aim to understand SBCE feasibility and specific limitations. Methods The perceived feasibility and efficacy of incorporating a low-fidelity medical simulation curriculum into this Native Alaskan healthcare system was evaluated by analyzing semi-structured interviews, focus groups, and surveys over a 15-month period (August 2018 - October 2019). Subjects were identified via both convenience and purposive sampling. Included were 40 healthcare workers who participated in the simulation curriculum, three local educators who were trained in and subsequently facilitated simulations, and seven institutional leaders identified as "key informants." Data included surveys with the Likert scale and dichotomous positive or negative data, as well as a thematic analysis of the qualitative portion of participant survey responses, focus group interviews of educators, and semi-structured interviews of key informants. Based on these data, feasibility was assessed in four domains: acceptability, demand, practicality, and implementation. Results Stakeholders and participants had positive buy-in for SBCE, recognizing the potential to improve provider confidence, standardize medical care, and improve teamwork and communication, all factors identified to optimize patient safety. The strengths listed support feasibility in terms of acceptability and demand. A number of challenges in the realms of practicality and implementation were identified, including institutional buy-in, need for a program champion in a setting of staff high turnover, and practicalities of scheduling and accessing participants working in one system across a vast and remote geographic region. Participants perceived the simulations to be effective and feasible. Conclusion While simulation participants valued an SBCE program, institutional leaders and educators identified veritable obstacles to the practical implementation of a structured program. Given the inherent challenges of this setting, a traditional simulation curriculum is unlikely to be fully feasibly integrated. However, due to the overall demand and social acceptability expressed by the participants, innovative ways to deliver simulation should be developed, trialed, and evaluated in the future.

Technologies for Biogas Upgrading to Biomethane: A Review.

The environmental impacts and high long-term costs of poor waste disposal have pushed the industry to realize the potential of turning this problem into an economic and sustainable initiative. Anaerobic digestion and the production of biogas can provide an efficient means of meeting several objectives concerning energy, environmental, and waste management policy. Biogas contains methane (60%) and carbon dioxide (40%) as its principal constituent. Excluding methane, other gasses contained in biogas are considered as contaminants. Removal of these impurities, especially carbon dioxide, will increase the biogas quality for further use. Integrating biological processes into the bio-refinery that effectively consume carbon dioxide will become increasingly important. Such process integration could significantly improve the sustainability of the overall bio-refinery process. The biogas upgrading by utilization of carbon dioxide rather than removal of it is a suitable strategy in this direction. The present work is a critical review that summarizes state-of-the-art technologies for biogas upgrading with particular attention to the emerging biological methanation processes. It also discusses the future perspectives for overcoming the challenges associated with upgradation. While biogas offers a good substitution for fossil fuels, it still not a perfect solution for global greenhouse gas emissions and further research still needs to be conducted.

Prototyping the Automated Food Imaging and Nutrient Intake Tracking System: Modified Participatory Iterative Design Sprint.

BACKGROUND: A total of 45% of older adults living in long-term care (LTC) have some form of malnutrition. Several methods of tracking food and fluid intake exist, but they are limited in terms of their accuracy and ease of application. An easy-to-use, objective, accurate, and comprehensive food intake system designed with LTC in mind may provide additional insights regarding nutritional support systems and nutritional interventions. OBJECTIVE: The aim of this study was to conduct a multistage participatory iterative design sprint of a Goldilocks quality horizontal prototype for the Automated Food Imaging and Nutrient Intake Tracking (AFINI-T) system. Specific design objectives included the following: (1) identify practice-relevant problems and solutions through user-centered participatory design, (2) mitigate feasibility-related barriers to uptake, and (3) employ user-centered technology development. METHODS: A 6-stage iterative participatory design sprint was developed and executed. A total of 38 participants and advisors representing 15 distinct roles (eg, personal support worker, nurse, and dietitian) were engaged in the design sprint. Subjective workload (Raw Task Load Index), subjective usability scales, and a modified Ravden checklist were used to assess project advisors' perceptions of the AFINI-T system prototype compared with the current method of food and fluid intake charting. RESULTS: The top priorities for this system were identified as the following: ease of use, high accuracy, system reliability, ease of maintenance, and requirement of integrating with the current PointClickCare system. Data from project advisors informed design decisions leading to a Goldilocks quality horizontal prototype of the AFINI-T system. Compared with the current food and fluid intake charting system, AFINI-T was perceived to have the following: less time demands (t10.8=4.89; P<.001), less effort (t13.5=5.55; P<.001), and less frustration (t13.0=3.80; P=.002). Usability ratings of the AFINI-T prototype were high, with a subjective usability score mean of 89.2 and the highest ratings on a modified Ravden usability checklist of "very satisfactory" for 7 out of 8 sections. CONCLUSIONS: The AFINI-T concept system appears to have good practice relevance as a tool for an intelligent food and fluid intake tracking system in LTC. The AFINI-T concept system may provide improvement over the current system, and advisors are keen to try the AFINI-T system. This research gives tangible examples of how the sprint method can be adapted and applied to the development of novel needs-based application-driven technology.

Extractability-mediated stability bias and hematocrit impact: High extraction recovery is critical to feasibility of volumetric adsorptive microsampling (VAMS) in regulated bioanalysis.

Volumetric absorptive microsampling (VAMS), a new microsampling technique, was evaluated for its potential in supporting regulated bioanalysis. Our initial assessment with MK-0518 (raltegravir) using a direct extraction method resulted in 45-52% extraction recovery, significant hematocrit (Ht) related bias, and more importantly, unacceptable stability (>15% bias from nominal concentration) after 7-day storage. Our investigation suggested that the observed biases were not due to VAMS absorption, sampling techniques, lot-to-lot variability, matrix effect, and/or chemical stability of the compound, but rather the low extraction recovery. An effort to improve assay recovery led to a modified liquid-liquid extraction (LLE) method that demonstrated more consistent performance, minimal Ht impact (Ht ranged from 20 to 65%), and acceptable sample stability. The same strategy was successfully applied to another more hydrophilic model compound, MK-0431 (sitagliptin). These results suggest that the previously observed Ht effect and "instability" were in fact due to inconsistent extractability, and optimizing the extraction recovery to greater than 80% was critical to ensure VAMS performance. We recommend adding Ht-independent recovery as part of feasibility assessment to de-risk the long-term extractability-mediated stability bias before implementing VAMS in regulated bioanalysis.

Feasibility Assessment of a New Surveillance Tool for Respiratory Protective Devices Used in U.S. Healthcare.

BACKGROUND: Respiratory protective devices (RPDs) are used for infection prevention in healthcare settings during routine patient care and public health emergencies. In recent years, healthcare systems have experienced shortages of RPDs during outbreaks of infectious diseases, in part due to a lack of information about their availability. New tools to track RPD inventories may improve accessibility during an emergency. Investigators at Vanderbilt University have identified four major themes that influence RPD use for infection prevention: hospital preparedness, responsiveness to airborne pathogens, potential exposure outcomes, and infection control practices related to respirator effectiveness. Based on these findings, an RPD surveillance tool (RST) was developed to collect and share near real-time data about RPD supplies in healthcare facilities. The objective of this study was to conduct a feasibility assessment of this RST. METHODS: The new online surveillance tool was implemented at four large, urban, acute care U.S. hospitals in January 2014; data was collected about RPD inventory, tracking systems, hospital characteristics, and utility of gathered information. RESULTS: The RST was implemented successfully and without difficulty at hospitals that had 78 to 90 percent occupancy rates. Participating hospitals reported that the RST (1) provided value for benchmarking their RPD supply, (2) promoted understanding about RPD accessibility among hospital systems engaged in infection control, and (3) served as a means to assess RPD program quality. CONCLUSION: Implementation of this newly developed RST is feasible and appears to have utility in U.S. hospitals for tracking and understanding RPD use for routine healthcare delivery and public health emergencies.