ResearchPad - safety https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Zinc isotope variations in archeological human teeth (Lapa do Santo, Brazil) reveal dietary transitions in childhood and no contamination from gloves]]> https://www.researchpad.co/article/elastic_article_14585 Zinc (Zn) isotope ratios of dental enamel are a promising tracer for dietary reconstruction in archeology, but its use is still in its infancy. A recent study demonstrated a high risk of Zn contamination from nitrile, and latex gloves used during chemical sample preparation. Here we assess the potential impact of the use of such gloves during enamel sampling on the Zn isotope composition of teeth from a population of early Holocene hunter gatherers from Lapa do Santo, Lagoa Santa, Minas Gerais, Brazil. We first examined the amount of Zn and its isotopic composition released from the gloves used in this study by soaking them in weak nitric acid and water. We compared Zn isotope ratios obtained from teeth that were sampled wearing nitrile, latex or no gloves. Finally, we performed a linear mixed model (LMM) to investigate post hoc the relationship between the gloves used for sampling and the Zn isotope variability in dental enamel. We found that the gloves used in this study released a similar amount of Zn compared to previous work, but only in acidic solution. Zn isotope ratios of teeth and the LMM identified no sign of significant Zn coming from the gloves when teeth were handled for enamel sampling. We hypothesize that Zn in gloves is mostly released by contact with acids. We found that the main source of Zn isotope variability in the Lapa do Santo population was related to the developmental stage of the tooth tissues sampled. We report identical results for two individuals coming from a different archeological context. Tooth enamel formed in utero and/or during the two first years of life showed higher Zn isotope ratios than enamel formed after weaning. More work is required to systematically investigate if Zn isotopes can be used as a breastfeeding tracer.

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<![CDATA[Preventing airborne infection]]> https://www.researchpad.co/article/elastic_article_13563 Good ventilation is essential in indoor spaces including planes

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<![CDATA[Battle Buddies: Rapid Deployment of a Psychological Resilience Intervention for Health Care Workers During the Coronavirus Disease 2019 Pandemic]]> https://www.researchpad.co/article/N1a6a301b-c6ff-4054-aac9-7873ac5fa3ee The outbreak of the coronavirus disease 2019 (COVID-19) and its rapid global spread have created unprecedented challenges to health care systems. Significant and sustained efforts have focused on mobilization of personal protective equipment, intensive care beds, and medical equipment, while substantially less attention has focused on preserving the psychological health of the medical workforce tasked with addressing the challenges of the pandemic. And yet, similar to battlefield conditions, health care workers are being confronted with ongoing uncertainty about resources, capacities, and risks; as well as exposure to suffering, death, and threats to their own safety. These conditions are engendering high levels of fear and anxiety in the shortterm, and place individuals at risk for persistent stressexposure syndromes, subclinical mental health symptoms, and professional burnout in the longterm. Given the potentially wide-ranging mental health impact of COVID-19, protecting health care workers from adverse psychological effects of the pandemic is critical. Therefore, we present an overview of the potential psychological stress responses to the COVID-19 crisis in medical providers and describe preemptive resilience-promoting strategies at the organizational and personal level. We then describe a rapidly deployable Psychological Resilience Intervention founded on a peersupport model (Battle Buddies) developed by the United States Army. This intervention—the product of a multidisciplinary collaboration between the Departments of Anesthesiology and Psychiatry & Behavioral Sciences at the University of Minnesota Medical Center—also incorporates evidence-informed “stress inoculation” methods developed for managing psychological stress exposure in providers deployed to disasters. Our multilevel, resource-efficient, and scalable approach places 2 key tools directly in the hands of providers: (1) apeersupport Battle Buddy; and (2) adesignated mental health consultant who can facilitate training in stress inoculation methods, provide additional support, or coordinate referral for external professional consultation. In parallel, we have instituted a voluntary research data-collection component that will enable us to evaluate the intervention’s effectiveness while also identifying the most salient resilience factors for future iterations. It is our hope that these elements will provide guidance to other organizations seeking to protect the well-being of their medical workforce during the pandemic. Given the remarkable adaptability of human beings, we believe that, by promoting resilience, our diverse health care workforce can emerge from this monumental challenge with new skills, closer relationships, and greater confidence in the power of community.

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<![CDATA[Ensuring the Biologic Safety of Plasma-Derived Therapeutic Proteins]]> https://www.researchpad.co/article/N280e5fe2-eb10-456e-93cd-524ecfba37e4

Human plasma-derived proteins, such as immunoglobulins, coagulation factors, α1-antitrypsin, fibrin sealants, and albumin, are widely used as therapeutics for many serious and life-threatening medical conditions. The human origin of these proteins ensures excellent efficacy and compatibility but may also introduce the risk of unintentional disease transmission. Historically, only viruses, particularly hepatitis and HIV, have posed serious threats to the safety of these therapeutics. Fortunately, between 1970 and 1990, the molecular biology of each of the major viruses was elucidated. These advances led to the development and implementation of effective donor screening tests, mainly based on immunoassays and nucleic acid testing, which resulted in a significant reduction of disease transmission risk. In addition, viral inactivation and removal steps were implemented and validated by manufacturers, further reducing the risk associated with known, as well as unidentified, viruses. Since the late 1990s, a different class of transmissible agent, referred to as prions, has been identified as a new risk for disease transmission. However, prion diseases are very rare, and prion transmission through plasma-derived proteins has not been reported to date. The prion-related risk is minimized by deferring donors with certain key risk factors, and by the manufacturing processes that are capable of removing prions. Advances in science and pathogen safety-related technology, compliance with good manufacturing practices by manufacturers, and increasingly stringent regulatory oversight, has meant that plasma-derived proteins have been developed into today’s highly effective therapeutics with very low risk of disease transmission.

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<![CDATA[Controlling infectious disease outbreaks in low-income and middle-income countries]]> https://www.researchpad.co/article/N804ec1c0-28cf-4562-8560-b4581e4c5b60

When an infectious disease outbreak is detected or suspected, a healthcare facility’s infection control personnel should be notified and an outbreak control team formed that is pertinent to the size and severity of the outbreak and healthcare facility. Management of an infectious disease outbreak in a middle- or low-income country is challenging. Cost-effective recommendations that are easy to carry out and that have been stratified according to the type of infection and prevention and control intervention used are provided in this paper and constitute basic practices.

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<![CDATA[Environmental Cleaning in Resource-Limited Settings]]> https://www.researchpad.co/article/Nd4de28fb-af94-4138-903e-f0c52431c1fd

Opinion statement

Purpose of review

Environmental surfaces in healthcare facilities, particularly in a patient room, are a critical pathway for healthcare-associated pathogen transmission. Despite well-established guides and recommendations regarding environmental surface cleaning and disinfection, there are several challenges in resource-limited settings. This viewpoint article will discuss the practice of environmental cleaning in resource-limited settings including challenges and relationship between environment and healthcare-associated infections in this setting and outlines pre-requisites to overcome these challenges.

Recent findings

Despite several barriers and challenges, environmental cleaning is a crucial component to help reduce transmission of healthcare-associated infections and multi-drug-resistant pathogens as well as emerging infectious disease-associated pathogens in resource-limited settings. However, there is a need to develop a multi-modal strategy together with a mechanism for monitor and feedback to improve the practices of environmental cleaning in resource-limited settings.

Summary

Additional researches on the barriers and implementation gaps and the role of collaborative network as well as how to apply technology would provide significant insights on the practices of environmental cleaning in resource-limited settings.

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<![CDATA[Impact of law enforcement and increased traffic fines policy on road traffic fatality, injuries and offenses in Iran: Interrupted time series analysis]]> https://www.researchpad.co/article/N9254ca97-b759-40e9-8001-23227e05911a

Background

Road traffic law enforcement was implemented on 1st April 2011 (the first intervention) and traffic ticket fines have been increased on 1st March 2016 (the second intervention) in Iran. The aim of the current study was to evaluate the effects of the law enforcement on reduction in the incidence rate of road traffic fatality (IRRTF), the incidence rate of road traffic injuries (IRRTI) and the incidence rate of rural road traffic offenses (IRRRTO) in Iran.

Methods

Interrupted time series analysis was conducted to evaluate the impact of law enforcement and increased traffic tickets fines. Monthly data of fatality on urban, rural and local rural roads, injuries with respect to gender and traffic offenses namely speeding, illegal overtaking and tailgating were investigated separately for the period 2009–2016.

Results

Results showed a reduction in the incidence rate of total road traffic fatality (IRTRTF), the incidence rate of rural road traffic fatality (IRRRTF) and the incidence rate of urban road traffic fatality (IRURTF) by –21.44% (–39.3 to –3.59, 95% CI), –21.25% (–31.32 to –11.88, 95% CI) and –26.75% (–37.49 to –16, 95% CI) through the first intervention which resulted in 0.383, 0.255 and 0.222 decline in casualties per 100 000 population, respectively. Conversely, no reduction was found in the incidence rate of local rural road traffic fatality (IRLRRTF) and the IRRTI. Second intervention was found to only affect the IRURTF with –26.75% (–37.49 to –16, 95% CI) which led to 0.222 casualties per 100 000 population. In addition, a reduction effect was observed on the incidence rate of illegal overtaking (IRIO) and the incidence rate of speeding (IRS) with –42.8% (–57.39 to –28.22, 95% CI) and –10.54% (–21.05 to –0.03, 95% CI which implied a decrease of 415.85 and 1003.8 in monthly traffic offenses per 100 000 vehicles), respectively.

Conclusion

Time series analysis suggests a decline in IRTRTF, IRRRTF, and IRURTF caused by the first intervention. However, the second intervention found to be only effective in IRURTF, IRIO, and IRS with the implication that future initiatives should be focused on modifying the implementation of the traffic interventions.

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<![CDATA[The priority setting of factors affecting a crash severity using the Analytic Network Process]]> https://www.researchpad.co/article/Nc9fa09a3-8ff5-49e0-a0a8-61405ec8eb61

Abstract:

Background:

The original step in reducing crash severity is recognition of the involved factors. The aim of this paper is to prioritize the factors affecting crashes severity. The current study was carried out in 2018 in Iran.

Methods:

The present cross-sectional study focuses on factors affecting the crash severity. Due to the compli-cated nature of traffic accidents, Multi-Criteria Decision-Making methods can be considered as an effective approach. In this work, the factors affecting a crash severity were identified and then attained factors were scored by ten traffic safety experts. To prioritize and weigh these factors, the Analytic Network Process method and Super Decisions program were used.

Results:

The results showed four main factors and 60 sub-factors in which the main factors in the order of priority were the safety (the most important sub-factor: speed over the upper limit), the other fac-tors (the most important sub-factor: road user type), the health (the most important sub-factor: drowsiness), and the environment (the most important sub-factor: slipping the road).

Conclusions:

In order to control the crash severity, the presented factors in this study could help traffic safety experts to prioritize and perform controlling actions.

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<![CDATA[Prevalence and pattern of domestic accidents in the field practice area of Jawaharlal Institute of Urban Health Centre, Puducherry: a cross-sectional analytical study]]> https://www.researchpad.co/article/N252d449f-451c-46a4-a000-03d9d035333c

Abstract:

Background:

Injuries constitute around 16% of the total disease burden in India with respect to Disability-Adjusted Life Years. More than two third of these injuries are unintentional and occur at household level. Domestic accidents are preventive and can be drastically reduced by effective measures and safety consciousness. This study aims to find the prevalence of domestic accidents, the household safety practices and their association with socio demographic factors in selected urban wards of Puducherry.

Methods:

A population-based cross sectional analytical study was conducted in the service area of Jawaharlal Institute of Postgraduate Medical Education and Research Urban Health Centre, Puducherry, in June 2018. Data regarding self-reported domestic accidents in the last one year were collected using a structured questionnaire and assessment of household hazards was done after examining the houses.

Results:

Among the 578 randomly selected households, 393(68%) belonged to nuclear families, 486(84%) had pucca houses and in 339(59%) overcrowding was present. 59(10.2%) households reported domestic accidents – of which 25(42%) had adult victims, 22(37%) were due to falls, 27(45%) had upper limb injuries and 25(43%) occurred in kitchen. On assessment of safety practices, 121(21%) houses had doors with stoppers, 394(68%) had items scattered on living room floor while 128(24%) and 160(30%) had grab bars and doormat in bathrooms respectively. Domestic accidents were more prevalent among overcrowded households - Prevalence Ratio: 1.74 ([95% CI: 1.02 – 2.98], p = 0.04).

Conclusions:

The prevalence of domestic accidents was 10.2% in the present study. It was reported mostly among the adults and in the kitchen, with falls being the most common cause and upper limbs injury being commonest. Most of the houses had objects lying scattered on the floor hindering movement; and stoppers and grab bars were missing from the doors and bathrooms respectively. Overcrowding was significantly associated with domestic accidents.

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<![CDATA[Infliximab-induced Depression and Suicidal Behavior in Adolescent with Crohn’s Disease]]> https://www.researchpad.co/article/N6243ed77-1904-482b-aee3-a6394f2e7afb

Introduction:

Infliximab, an anti-inflammatory agent, is used to treat various autoimmune disorders. There are at least 3 reports of severe psychiatric adverse effects of the drug, including suicidal behaviors in adults and psychosis in adult and adolescent patients. We report a case of an adolescent who developed depression and suicidal behaviors shortly after beginning infliximab. Although there have been reports of adolescents developing acute psychosis shortly after starting infliximab, this is, to our knowledge, the first report of adolescent suicidal behavior in the setting of infliximab treatment.

Methods:

We describe a patient’s presentation and clinical course, as well as existing reports of adverse psychiatric effects of infliximab.

Results:

A 16-year-old male with a 2-year history of disabling symptoms and complications of Crohn’s disease was initiated on a trial of infliximab. Within days of the first infliximab infusion, he experienced symptoms of depression, which intensified over weeks and resulted in a serious suicide attempt. The patient was treated with fluoxetine, melatonin, and psychotherapy, which effectively managed his infliximab-induced depressive disorder with suicidal thoughts and behaviors. Posttreatment, he tolerated additional infliximab infusions without the recurrence of psychiatric symptoms.

Conclusions:

Treatment with infliximab may rarely and suddenly cause severe and potentially life-threatening psychiatric symptoms. Therefore, youth with chronic illnesses considered for infliximab treatment should be screened for preexisting, as well as for a family history of, psychiatric disorders and suicidal behavior.

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<![CDATA[Near Miss in Intraoperative Magnetic Resonance Imaging: A Case for In Situ Simulation]]> https://www.researchpad.co/article/N4390de29-bafd-496c-a0e7-81a770d28c17

Introduction:

Pediatric patients in intraoperative magnetic resonance imaging (iMRI) settings are at high risk for morbidity should an adverse event occur. We describe an experience in the iMRI scanner where no harm occurred, yet revealed an opportunity to improve the safety of patients utilizing the iMRI. The perioperative quality improvement team, resuscitation team, and radiology nurse leadership collaborated to understand the process better through in situ simulation.

Methods:

After a problem analysis, the team planned an in situ, high-fidelity simulation with predefined learning objectives to identify previously overlooked opportunities for improvement. The iMRI simulation had unique considerations, including the use of a magnetic resonance imaging (MRI)-compatible mannequin and ensuring participants' safety. Audiovisual equipment was placed in strategic locations to record the MRI and operating room (OR) segments of the simulation, and trained health-care simulation experts provided debriefing.

Results:

After completion of the iMRI simulation, the quality improvement team solicited feedback from participants and reviewed the video-recorded simulation. Several opportunities for improvement surrounding staff responsibilities and unique aspects of the iMRI environment were identified.

Conclusions:

iMRI in situ simulation has not been previously described. It presents unique challenges given the integration of personnel from OR and radiology environments, anesthetized patients, and risks from the high-powered MRI magnet. Other institutions utilizing hybrid ORs with iMRI may consider conducting in situ simulations using the described methods.

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<![CDATA[Onsite investigation at a mail-order hatchery following a multistate Salmonella illness outbreak linked to live poultry—United States, 2018]]> https://www.researchpad.co/article/Nc0c78a3b-3374-4fea-afdf-f3f17d8de412

ABSTRACT

Centers for Disease Control and Prevention (CDC), health departments, and other state and federal partners have linked contact with live poultry to 70 human Salmonella outbreaks in the United States from 2000 to 2017, which resulted in a total of 4,794 illnesses, 894 hospitalizations, and 7 deaths. During human salmonellosis outbreaks environmental sampling is rarely conducted as part of the outbreak investigation. CDC was contacted by state health officials on June 12, 2018, to provide support during an investigation of risk factors for Salmonella infections linked to live poultry originating at a mail-order hatchery. From January 1, 2018, to June 15, 2018, 13 human Salmonella infections in multiple states were attributed to exposure to live poultry from a single hatchery. Two serotypes of Salmonella were associated with these infections, Salmonella Enteritidis and Salmonella Litchfield. Molecular subtyping of the S. Enteritidis clinical isolates revealed they were closely related genetically (within 0 to 9 alleles) by core genome multi-locus sequence typing (cgMLST) to isolates obtained from environmental samples taken from hatchery shipping containers received at retail outlets. Environmental sampling and onsite investigation of practices was conducted at the mail-order hatchery during an investigation on June 19, 2018. A total of 45 environmental samples were collected, and 4 (9%) grew Salmonella. A chick box liner from a box in the pre-shipping area yielded an isolate closely related to the S. Enteritidis outbreak strain (within 1 to 9 alleles by cgMLST). The onsite investigation revealed lapses in biosecurity, sanitation, quality assurance, and education of consumers. Review of Salmonella serotype testing performed by the hatchery revealed that the number of samples and type of samples collected monthly varied. Also, S. Enteritidis was identified at the hatchery every year since testing began in 2016. Recommendations to the hatchery for biosecurity, testing, and sanitation measures were made to help reduce burden of Salmonella in the hatchery and breeding flocks, thereby reducing the occurrence of human illness.

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<![CDATA[Evaluating the relationship between adult attention-deficit/hyperactivity disorder and riding behavior of motorcyclists]]> https://www.researchpad.co/article/5c9e599bd5eed0c4842433e0

Abstract:

Background:

Motorcycling is one of the main causes of injury, and motorcyclists are vulnerable to road traffic injuries. Attention Deficit Hyperactivity Disorder (ADHD) in adults is presumably one of the determinants of road traffic injuries and motorcyclists’ risky behavior. Despite the few studies on the relationship between motorcycle injuries and adult ADHD, their association has not been investigated using standardized instruments. This study aimed to analyze the relationship between motorcyclists’ adult ADHD and risky riding behaviors.

Methods:

This community-based, cross-sectional study was performed on 340 motorcyclists in Bukan city, west Azerbaijan province, Iran in 2015 and 2016 using a cluster-random sampling in seven areas of the city. According to the city map used by Bukan’s Health Centers, the city was divided into 14 clusters. Then, seven clusters (out of 14) were selected randomly. To reach the anticipated sample size, the data were collected from these seven clusters. In this study, the data collection instruments were: standard Motorcycle Rider Behavior Questionnaire (MRBQ), Conners' Adult ADHD Rating Scales (CAARS) questionnaire and a checklist designed by the researchers. The Stata 13 software package was used to analyze the collected data. Pearson correlation coefficient and multiple linear regression were performed to study the linear relationship between ADHD screening and MRBQ scores.

Results:

All 340 participants were male and the mean age was 30.2 years (SD=9.1). In addition, 22.1% of motorcyclists had a history of motorcycle crash. Bivariate analysis showed a significant association between risky riding behaviors and age, motorcycling records, and mean of riding hours per day (P-value less than 0.05). Multivariate analysis confirmed the correlation between ADHD and risky riding behaviors in all subscales (A, B, D) (p less than 0.05).

Conclusions:

Those with a high ADHD screening score are more likely to have risky riding behaviors.

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<![CDATA[Data Omission by Physician Trainees on ICU Rounds*]]> https://www.researchpad.co/article/5c973c64d5eed0c484968642

Supplemental Digital Content is available in the text.

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<![CDATA[Differential completeness of spontaneous adverse event reports among hospitals/clinics, pharmacies, consumers, and pharmaceutical companies in South Korea]]> https://www.researchpad.co/article/5c6f14f7d5eed0c48467abbe

The differential pattern and characteristics of completeness in adverse event (AE) reports generated by hospitals/clinics, pharmacies, consumer and pharmaceutical companies remain unknown. Thus, we identified the characteristics of complete AE reports, compared with those of incomplete AE reports, using a completeness score. We used Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) between January 1, 2016 and December 31, 2016. The completeness score was determined out of a total of 100 points, based on the presence of information on temporal relationships, age and sex of patients, AE progress, name of reported medication, reporting group by profession, causality assessment, and informational text. AE reports were organized into four groups based on affiliation: hospitals/clinics, pharmacies, consumers, and pharmaceutical companies. Affiliations that had median completeness scores greater than 80 points were classified as ‘well-documented’ and these reports were further analyzed by logistic regression to estimate the adjusted odds ratios and 95% confidence intervals. We examined 228,848 individual reports and 735,745 drug-AE combinations. The median values of the completeness scores were the highest for hospitals/clinics (95 points), followed by those for consumers (85), pharmacies (75), and manufacturers (72). Reports with causality assessment of ‘certain’, ‘probable’, or ‘possible’ were more likely to be ‘well-documented’ than reports that had causality assessments of ‘unlikely’. Serious reports of AEs were positively associated with ‘well-documented’ reports and negatively associated with hospitals/clinics.

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<![CDATA[Magnitude of road traffic accident related injuries and fatalities in Ethiopia]]> https://www.researchpad.co/article/5c59fea3d5eed0c4841351e4

Background

In many developing countries there is paucity of evidence regarding the epidemiology of road traffic accidents (RTAs). The study determines the rates of injuries and fatalities associated with RTAs in Ethiopia based on the data of a recent national survey.

Methods

The study is based on the secondary data of the Ethiopian Demographic and Health Survey conducted in 2016. The survey collected information about occurrence injuries and accidents including RTAs in the past 12 months among 75,271 members of 16,650 households. Households were selected from nine regions and two city administrations of Ethiopia using stratified cluster sampling procedure.

Results

Of the 75,271 household members enumerated, 123 encountered RTAs in the reference period and rate of RTA-related injury was 163 (95% confidence interval (CI): 136–195) per 100,000 population. Of the 123 causalities, 28 were fatal, making the fatality rate 37 (95% CI: 25–54) per 100,000 population. The RTA-related injuries and fatalities per 100,000 motor vehicles were estimated as 21,681 (95% CI: 18,090–25,938) and 4,922 (95% CI: 3325–7183), respectively. Next to accidental falls, RTAs were the second most common form of accidents and injuries accounting for 22.8% of all such incidents. RTAs contributed to 43.8% of all fatalities secondary to accidents and injuries. Among RTA causalities, 21.9% were drivers, 35.0% were passenger vehicle occupants and 36.0% were vulnerable road users including: motorcyclists (21.0%), pedestrians (12.1%) and cyclists (2.9%). Approximately half (47.1%) of the causalities were between 15–29 years of age and 15.3% were either minors younger than 15 years or seniors older than 64 years of age. Nearly two-thirds (65.0%) of the victims were males.

Conclusion

RTA-related causalities are extremely high in Ethiopia. Male young adults and vulnerable road users are at increased risk of RTAs. There is a urgent need for bringing road safety to the country's public health agenda.

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<![CDATA[A tolerability assessment of new respiratory protective devices developed for health care personnel: A randomized simulated clinical study]]> https://www.researchpad.co/article/5c3fa600d5eed0c484cab058

Background

U.S. health care personnel (HCP) have reported that some respiratory protective devices (RPD) commonly used in health care have suboptimal tolerability. Between 2012 and 2016, the U.S. National Institute for Occupational Safety and Health, and the Veterans Health Administration collaborated with two respirator manufacturers, Company A and B, to bring new RPD with improved tolerability to the U.S. health care marketplace. The purpose of this study was to compare the tolerability of four new prototype RPD to two models commonly used in U.S. health care delivery.

Methods

A randomized, simulated workplace study was conducted to compare self-reported tolerability of four new prototype RPD (A1, A2, B1, and B2) worn by HCP and two N95 control respirators commonly used in U.S. health care delivery, the 1870 and 1860, manufactured by 3M Corporation. A new survey tool, the Respirator Comfort, Wearing Experience, and Function Instrument (R-COMFI), developed previously in part for the current study, was used as the primary outcome metric. With a maximum total score of 47, lower R-COMFI scores reflected better self-reported tolerability. Poisson regression analyses were used to estimate prototype relative risks compared to controls.

Results

Conducted between 2014 and 2015 in two inpatient care rooms at the North Florida/South Georgia Veterans Health System, among 383 participants who enrolled, 335 (87.5%) completed the study. Mean total R-COMFI scores for the 3M 1870, 3M 1860, and prototypes A1, A2, B1, and B2 were 8.26, 9.36, 5.79, 7.70, 6.09, and 5.71, respectively. Compared to the 3M 1870, total R-COMFI unadjusted relative risks (RR) and 95 percent confidence intervals (CI) were A1 (RR 0.70, CI 0.60, 0.82), A2 (RR 0.93, CI 0.82, 1.06), B1 (RR 0.74, CI 0.64, 0.85), and B2 (RR 0.69, CI 0.60, 0.80). Compared to the 3M 1860, prototype total R-COMFI unadjusted RR and 95 percent CI were A1 (RR 0.62, CI 0.53, 0.72), A2 (RR 0.82, CI 0.73, 0.93), B1 (RR 0.65, CI 0.57, 0.74), and B2 (RR 0.61, CI 0.53, 0.70). Similarly, models adjusted for demographic characteristics showed that prototypes A1, B1, and B2 significantly improved tolerability scores compared to both controls, while prototype A2 was significantly improved compared to the 3M 1860.

Conclusions

Compared to the 3M 1870 and 3M 1860, two RPDs commonly used in U.S. health care delivery, tolerability improved for three of four newly developed prototypes in this simulated workplace study. The R-COMFI tool, used in this study to assess tolerability, should be useful for future comparative studies of RPD.

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<![CDATA[Safety and efficacy of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in patients aged 65 years or older]]> https://www.researchpad.co/article/5c3667e9d5eed0c4841a68f0

Finding safe and effective treatments for chronic hepatitis C virus (HCV) infection in the elderly is of clinical interest given the comorbidities and associated polypharmacy in this population. However, the number of patients older than age 65 years enrolled into clinical trials of anti-HCV medications generally have been limited and thus reaching meaningful conclusions for this demographic has been difficult. Glecaprevir/pibrentasvir is a once-daily, all-oral, ribavirin-free, pangenotypic direct-acting antiviral (DAA) combination therapy that has demonstrated high sustained virologic response rates at post-treatment week 12 (SVR12) and a favorable safety profile in patients with chronic HCV infection. This analysis evaluated the safety and efficacy of glecaprevir/pibrentasvir in patients aged ≥65 years. Data were pooled for treatment-naïve and -experienced patients with chronic HCV genotype (GT) 1–6 infections who received glecaprevir/pibrentasvir for 8, 12, or 16 weeks in 9 Phase 2 and 3 trials. SVR12 and adverse events (AEs) were evaluated for patients aged ≥65 versus <65 years. Of the 2369 patients enrolled, 328 (14%) were aged ≥65 years. Among patients aged ≥65 years, 42% and 34% had GT1 and GT2, respectively; 40% were treatment-experienced and 20% had compensated cirrhosis. Glecaprevir/pibrentasvir treatment resulted in SVR12 rates of 97.9% (95% CI, 96.3–99.4; n/N = 321/328) for patients aged ≥65 years and 97.3% (95% CI, 96.6–98.0; n/N = 1986/2041) for patients aged <65 years. The rates were not significantly different between the two age groups (P = 0.555). DAA-related AEs leading to treatment discontinuation, or serious AEs were similarly rare (<0.5%) for patients ≥65 and <65 years old. Glecaprevir/pibrentasvir is an efficacious and well-tolerated treatment option for patients aged ≥65 years with chronic HCV infection.

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<![CDATA[Biological Safety: Principles and Practices, 5th Edition]]> https://www.researchpad.co/article/5c354d22d5eed0c484dd3daf ]]> <![CDATA[Towards a conceptual model for the use of home healthcare medical devices: The multi-parameter monitor case]]> https://www.researchpad.co/article/5c141e93d5eed0c484d2740f

In the last decade there has been an increase in the use of medical devices in the home environment. These devices are commonly the same as those used in hospitals by healthcare professionals. The use of these these devices by lay users outside of a clinical environment may become unsafe. This study presents a methodology that allows decision makers to identify potential risk situations that may arise when lay users operate healthcare medical devices at home. Through a usability study based on the Grounded Theory methodology, we create a conceptual model in which we identified problems and errors related to the use of a multi-parameter monitor in a home environment by a group of lay users. The conceptual model is reified as a graphical representation, which allows stakeholders to identify (i) the weaknesses of the device, (ii) unsafe operation modes, and (iii) the most suitable device for a specific user.

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