scholarly journals Preclinical Validation of a Novel Injection-Molded Swab for the Molecular Assay Detection of SARS-CoV-2

Diagnostics ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. 206
Author(s):  
Chiara E. Ghezzi ◽  
Devon R. Hartigan ◽  
Justin P. Hardick ◽  
Rebecca Gore ◽  
Miryam Adelfio ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Medical Devices ◽  
Clinical Studies ◽  
Cost Effective ◽  
Care Providers ◽  
Nasal Tissue ◽  
Significant Difference ◽  
Injection Molded ◽  
Development And Validation

During the COVID-19 public health emergency, many actions have been undertaken to help ensure that patients and health care providers have timely and continued access to high-quality medical devices to respond effectively. The development and validation of new testing supplies and equipment, including collection swabs, has helped to expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 emergency. Here, we report the initial validation of a new injection-molded anterior nasal swab, ClearTip™, that was experimentally validated in a laboratory setting as well as in independent clinical studies in comparison to gold standard flocked swabs. We have also developed an in vitro anterior nasal tissue model which offers a novel, efficient, and clinically relevant validation tool to replicate the clinical swabbing workflow with high fidelity, while being accessible, safe, reproducible, and time- and cost-effective. ClearTip™ displayed greater inactivated virus release in the benchtop model, confirmed by its greater ability to report positive samples in a small clinical study in comparison to flocked swabs. We also quantified the detection of biological materials, as a proxy for viral material, in multi-center pre-clinical and clinical studies which showed a statistically significant difference in one study and a reduction in performance in comparison to flocked swabs. Taken together, these results emphasize the compelling benefits of non-absorbent injection-molded anterior nasal swabs for COVID-19 detection, comparable to standard flocked swabs. Injection-molded swabs, as ClearTip™, could have the potential to support future swab shortages, due to its manufacturing advantages, while offering benefits in comparison to highly absorbent swabs in terms of comfort, limited volume collection, and potential multiple usage.

scholarly journals Preclinical and clinical validation of a novel injected molded swab for molecular assay detection of SARS-CoV-2 virus

2021 ◽  
Author(s):  
Chiara Elia Ghezzi ◽  
Devon R Hartigan ◽  
Justin Hardick ◽  
Rebecca Gore ◽  
Miryam Adelfio ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Medical Devices ◽  
Clinical Studies ◽  
Nasal Swab ◽  
Cost Effective ◽  
Slight Reduction ◽  
Care Providers ◽  
Significant Difference ◽  
Injection Molded

During the COVID-19 public health emergency, many actions have been undertaken to help ensure that patients and health care providers had timely and continued access to high-quality medical devices to respond effectively. The development and validation of new testing supplies and equipment, including collection swab, help expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 emergency. Here, we report the validation of a new injection-molded anterior nasal swab, ClearTip™, that was experimentally validated in a laboratory setting as well as in independent clinical studies in comparison to gold standard flocked swabs. We have also developed an in vitro anterior nasal tissue model, that offers an efficient and clinically relevant validation tool to replicate with high fidelity the clinical swabbing workflow, while being accessible, safe, reproducible, time and cost effective. ClearTi™ displayed a greater efficiency of release of inactivated virus in the benchtop model, confirmed by greater ability to report positive samples in a clinical study in comparison to flocked swabs. We also quantified in multi-center pre-clinical and clinical studies the detection of biological materials, as proxy for viral material, that showed a statistically significant difference in one study and a slight reduction in performance in comparison to flocked swabs. Taken together these results underscore the compelling benefits of non-absorbent injected molded anterior nasal swab for COVID-19 detection, comparable to standard flocked swabs. Injection-molded swabs, as ClearTip™, could have the potential to support future swab shortage, due to its manufacturing advantages, while offering benefits in comparison to highly absorbent swabs in terms comfort, limited volume collection, and potential multiple usage.

scholarly journals A descriptive analysis of end-of-life discussions for high-grade glioma patients

2021 ◽  
Author(s):  
Ai Chikada ◽  
Sayaka Takenouchi ◽  
Yoshiki Arakawa ◽  
Kazuko Nin
Keyword(s):  
End Of Life ◽  
Health Care Providers ◽  
Patient Participation ◽  
High Grade Glioma ◽  
Team Approach ◽  
High Grade ◽  
Care Providers ◽  
Patient Goals ◽  
Significant Difference ◽  
Eol Care

Abstract Background End-of-life discussions (EOLDs) in patients with high-grade glioma (HGG) have not been well described. Therefore, this study examined the appropriateness of timing and the extent of patient involvement in EOLDs and their impact on HGG patients. Methods A cross-sectional survey was conducted among 105 bereaved families of HGG patients at a university hospital in Japan between July and August 2019. Fisher’s exact test and the Wilcoxon rank-sum test were used to assess the association between patient participation in EOLDs and their outcomes. Results In total, 77 questionnaires were returned (response rate 73%), of which 20 respondents replied with refusal documents. Overall, 31/57 (54%) participated in EOLDs at least once in acute hospital settings, and a significant difference was observed between participating and nonparticipating groups in communicating the patient’s wishes for EOL care to the family (48% vs 8%, P = .001). Moreover, >80% of respondents indicated that the initiation of EOLDs during the early diagnosis period with patients and families was appropriate. Most EOLDs were provided by neurosurgeons (96%), and other health care providers rarely participated. Additionally, patient goals and priorities were discussed in only 28% of the EOLDs. Patient participation in EOLDs was not associated with the quality of EOL care and a good death. Conclusions Although participation in EOLDs is relatively challenging for HGG patients, this study showed that participation in EOLDs may enable patients to express their wishes regarding EOL care. It is important to initiate EOLDs early on through an interdisciplinary team approach while respecting patient goals and priorities.

scholarly journals The Role of Obesity in Predicting the Clinical Outcomes of COVID-19

Obesity Facts ◽  
2021 ◽  
pp. 1-9
Author(s):  
Serdar Sahin ◽  
Havva Sezer ◽  
Ebru Cicek ◽  
Yeliz Yagız Ozogul ◽  
Murat Yildirim ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Health Care Providers ◽  
Study Groups ◽  
Normal Weight ◽  
Overweight And Obesity ◽  
Care Providers ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Group D

<b><i>Introduction:</i></b> The aim of this was to describe the predictors of mortality related to COVID-19 infection and to evaluate the association between overweight, obesity, and clinical outcomes of COVID-19. <b><i>Methods:</i></b> We included the patients &#x3e;18 years of age, with at least one positive SARS-CoV-2 reverse transcriptase-polymerase chain reaction. Patients were grouped according to body mass index values as normal weight &#x3c;25 kg/m<sup>2</sup> (Group A), overweight from 25 to &#x3c;30 kg/m<sup>2</sup> (Group B), Class I obesity 30 to &#x3c;35 kg/m<sup>2</sup> (Group C), and ≥35 kg/m<sup>2</sup> (Group D). Mortality, clinical outcomes, laboratory parameters, and comorbidities were compared among 4 groups. <b><i>Results:</i></b> There was no significant difference among study groups in terms of mortality. Noninvasive mechanical ventilation requirement was higher in group B and D than group A, while it was higher in Group D than Group C (Group B vs. Group A [<i>p</i> = 0.017], Group D vs. Group A [<i>p</i> = 0.001], and Group D vs. Group C [<i>p</i> = 0.016]). Lung involvement was less common in Group A, and presence of hypoxia was more common in Group D (Group B vs. Group A [<i>p</i> = 0.025], Group D vs. Group A [<i>p</i> &#x3c; 0.001], Group D vs. Group B [<i>p</i> = 0.006], and Group D vs. Group C [<i>p</i> = 0.014]). The hospitalization rate was lower in Group A than in the other groups; in addition, patients in Group D have the highest rate of hospitalization (Group B vs. Group A [<i>p</i> &#x3c; 0.001], Group C vs. Group A [<i>p</i> &#x3c; 0.001], Group D vs. Group A [<i>p</i> &#x3c; 0.001], Group D vs. Group B [<i>p</i> &#x3c; 0.001], and Group D vs. Group C [<i>p</i> = 0.010]). <b><i>Conclusion:</i></b> COVID-19 patients with overweight and obesity presented with more severe clinical findings. Health-care providers should take into account that people living with overweight and obesity are at higher risk for COVID-19 and its complications.

scholarly journals A comparison of women’s expectations of labour and birth with the experiences in primiparas and multiparas with normal vaginal delivery

2016 ◽  
Vol 4 (1) ◽  
pp. 16-25 ◽  
Author(s):  
Manijeh Pirdil ◽  
Leila Pirdel
Keyword(s):  
Health Care ◽  
Vaginal Delivery ◽  
Health Care Providers ◽  
Normal Vaginal Delivery ◽  
Care Providers ◽  
Medical College ◽  
Childbirth Experience ◽  
Significant Difference ◽  
Negative Expectations

Background: Maternal childbirth expectations play an important role in determining a woman’s response to her childbirth experience. Women need to be helped to develop realistic and positive expectations and identify the factors that influence these expectations.Objective: The aim of this study was to compare woman’s expectations and experiences of childbirth.Methods: This descriptive-comparative study was carried out in Tabriz Alzahra Hospital from 2006 to 2007. For this purpose, a total of 600 primiparas and multiparas women who were candidates for vaginal delivery, were randomly selected and interviewed. The data were collected by questionnaire.Results: Comparison of the means of mothers expectation and experience of labor and birth between the two groups demonstrated a statistically significant difference (p<0.05). The findings indicated a number of differences exist between primiparas and multiparas women in relation to expectations and experiences of birth when compare two groups. The majority of women had negative expectations and experiences of childbirth.Conclusion: The evaluation and understanding of birth expectations and experiences as positive and negative is priority of maternity system. Antenatal educators need to ensure that pregnant women are appropriately prepared for what might actually happen to limit this expectation-experience gap. Health-care providers should improve the quality of antenatal care which can change negative childbirth expectations and experiences of womenJournal of Kathmandu Medical College, Vol. 4(1) 2015, 16-25

scholarly journals The Effect of "Pathway" to Diagnosis for Childhood ITP on Caregiver Quality of Life at Time of Diagnosis

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2174-2174
Author(s):  
Michelle Neier ◽  
Michele P. Lambert ◽  
Rachael F. Grace ◽  
Kerry Hege ◽  
Stephanie Chiu ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Provider ◽  
Health Care Providers ◽  
Care Provider ◽  
Research Funding ◽  
Care Providers ◽  
Significant Difference ◽  
Time To Diagnosis ◽  
The Impact

Background: Immune thrombocytopenia (ITP) is an immune mediated bleeding disorder characterized by isolated thrombocytopenia. ITP can have a variety of presentations from asymptomatic to life threatening bleeding. Although childhood ITP is most often a self-resolving illness which can be closely observed without intervention, it can be associated with significant impact on quality of life (QoL). Prospective studies of QoL in ITP patients show that there is not always a correlation with treatment or disease severity. The pathway from initial presentation to final diagnosis varies and may include encounters with emergency room, primary care or specialty providers. There have been no published studies to date showing the impact of factors prior to the diagnosis of ITP on treatment decision making and QoL. Objective: To identify the role of physician-patient and physician-caregiver interactions on the QoL and emotional well-being of patients and their families. Ascertaining the impact of pre-diagnosis factors may provide an opportunity to improve access and quality of care provided. Methods: The ITP Consortium of North America (ICON) "Pathways" study was a multicenter observational prospective cohort study focused on the pathways to diagnosis of ITP. The study was supported by a Foundation for Morristown Medical Center Research Fund Grant. Subjects were included if they had presumed primary ITP and were age >12 months to <18 years. Subjects were excluded if they had secondary ITP, including Evans syndrome. Treatment was determined by the physician. Subjects were consented and presented with questionnaires to be completed at the conclusion of the initial hematology visit. The hematologist also completed survey data at that time. Survey data forms included demographic form, physician form, Peds QL Family Impact Questionnaire, Kids ITP tools (KIT) Parent Impact Report and parent proxy report, and child (patient) KIT self-report. There was a parent questionnaire which included a question about worry with a scale from 0 to 10. Study data were collected and managed using REDCap electronic data capture tools hosted at Atlantic Health System. Correlation between variables were calculated using Pearson coefficient or Spearman's rho depending on the distribution of the data variables. Results: Sixty subjects and caregivers were enrolled at 6 ICON centers; 52 were eligible for inclusion. The majority (40%) had Grade 1 bleeding. Most patients (82%) were seen in outpatient hematology clinic by the hematologist and had been referred by the emergency room (73%). The median time to consultation with a hematologist from onset of symptoms was 7 days (1-199) and the median time to diagnosis by hematologist from initial contact with a health care provider was 5 days (0-154). Most subjects had seen 2 health care providers prior to the hematologist. KIT proxy report cumulative scores were a mean of 76.03 (SD 14.72). There was no significant difference between the time to diagnosis or the time from initial encounter with health care provider to hematologist and initial level of worry (p=0.70 and 0.90, respectively). There was also no significant difference between the time to diagnosis or the time from initial encounter with health care provider to hematologist and KIT proxy scores (p=0.96 and 0.50, respectively). However, there was a significant decline in level of worry (scale 0-10) prior to the hematologist visit (median 8, range 1-10) to after the visit (median 4, range 1-10). The association between number of medical providers encountered prior to diagnosis and KIT proxy scores was not significant (p=0.45) (Table). Conclusions: In this study at 6 teaching institutions, we were unable to detect a significant difference in proxy-reported KIT scores relative to the number of health care providers seen or time from diagnosis until the first encounter with the hematologist. We were, however, able to detect a significant change in the level of caregiver worry pre- and post- visit with the pediatric hematologist, supporting a benefit of specialist care to the caregivers of children with ITP. This study was limited by its small sample size and retrospective design. ITP is considered a benign disease but is associated with a significant amount of worry and impact on QoL for patients and caregivers which warrants further investigation. Disclosures Lambert: CSL Behring: Consultancy; Amgen: Consultancy, Other; Bayer: Other: Ad boards; Novartis: Other: Ad boards, Research Funding; Shionogi: Consultancy; Kedrion: Consultancy; Sysmex: Consultancy; AstraZeneca: Research Funding; PDSA: Research Funding. Grace:Agios Pharmaceuticals, Inc: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Research Funding.

scholarly journals Has Metal-On-Metal Resurfacing Been a Cost-Effective Intervention for Health Care Providers?—A Registry Based Study

PLoS ONE ◽  
2016 ◽  
Vol 11 (11) ◽  
pp. e0165021
Author(s):  
Ruth Pulikottil-Jacob ◽  
Martin Connock ◽  
Ngianga-Bakwin Kandala ◽  
Hema Mistry ◽  
Amy Grove ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Cost Effective ◽  
Effective Intervention ◽  
Care Providers ◽  
Metal On Metal

Perceived Health Status in Rural Manufacturing Workers

2018 ◽  
Vol 67 (2) ◽  
pp. 78-86
Author(s):  
Stacy Logsdon ◽  
M. Laurie Branstetter ◽  
Eve Main
Keyword(s):  
Health Status ◽  
Occupational Health ◽  
Health Care Providers ◽  
Retrospective Chart Review ◽  
Perceived Health ◽  
Care Providers ◽  
Perceived Health Status ◽  
Biometric Data ◽  
Objective Health ◽  
Significant Difference

Manufacturing workers comprise 8.8% of the total U.S. workforce representing a sizable population for disease prevention and health promotion by occupational health nurses within worksite wellness programs. The purpose of this study was to examine the relationship between perceived health status and objective health status including existing chronic disease among rural manufacturing workers. Rural manufacturing workers ( n = 114) completed a general health survey and consented to a retrospective chart review. All were participants in a direct incentive wellness program with biometric data available. The majority of participants were males between the ages of 46 and 60 years, and nearly half of the sample had a college degree. A statistically significant difference was observed between number of chronic diseases and lower perceived health status. These findings have implications for occupational health nurses and other health care providers to identify workers at risk for chronic illness through self-perceived health status assessment.

scholarly journals Flavonoids and Their Anti-Diabetic Effects: Cellular Mechanisms and Effects to Improve Blood Sugar Levels

Biomolecules ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. 430 ◽  
Author(s):  
AL-Ishaq ◽  
Abotaleb ◽  
Kubatka ◽  
Kajo ◽  
Büsselberg
Keyword(s):  
Health Care Providers ◽  
Molecular Mechanisms ◽  
Glucose Transporter ◽  
Kinase Inhibitor ◽  
Current Knowledge ◽  
Care Providers ◽  
Hepatic Enzymes ◽  
Positive Role ◽  
Dietary Flavonoids

Diabetes mellitus (DM) is a prevailing global health metabolic disorder, with an alarming incidence rate and a huge burden on health care providers. DM is characterized by the elevation of blood glucose due either to a defect in insulin synthesis, secretion, binding to receptor, or an increase of insulin resistance. The internal and external factors such as obesity, urbanizations, and genetic mutations could increase the risk of developing DM. Flavonoids are phenolic compounds existing as secondary metabolites in fruits and vegetables as well as fungi. Their structure consists of 15 carbon skeletons and two aromatic rings (A and B) connected by three carbon chains. Flavonoids are furtherly classified into 6 subclasses: flavonols, flavones, flavanones, isoflavones, flavanols, and anthocyanidins. Naturally occurring flavonoids possess anti-diabetic effects. As in vitro and animal model’s studies demonstrate, they have the ability to prevent diabetes and its complications. The aim of this review is to summarize the current knowledge addressing the antidiabetic effects of dietary flavonoids and their underlying molecular mechanisms on selected pathways: Glucose transporter, hepatic enzymes, tyrosine kinase inhibitor, AMPK, PPAR, and NF-κB. Flavonoids improve the pathogenesis of diabetes and its complications through the regulation of glucose metabolism, hepatic enzymes activities, and a lipid profile. Most studies illustrate a positive role of specific dietary flavonoids on diabetes, but the mechanisms of action and the side effects need more clarification. Overall, more research is needed to provide a better understanding of the mechanisms of diabetes treatment using flavonoids.

Knowledge Based Commissioning: Can a National Clinical Effectiveness Policy Be Compatible with Seeking Local Professional Advice?

1996 ◽  
Vol 1 (1) ◽  
pp. 28-34 ◽  
Author(s):  
Peter Littlejohns ◽  
Carol Dumelow ◽  
Sian Griffiths
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Care Providers ◽  
Professional Advice ◽  
Knowledge Based ◽  
Artery Disease ◽  
Health Care Purchasing ◽  
The Right

Objectives: To help develop a means, based on the views of purchasers and providers of health care, of incorporating national research on clinical effectiveness into local professional advisory mechanisms in order to inform health care purchasing and contracting. Methods: Three geographically based multidisciplinary workshops attended by National Health Service (NHS) staff drawn from the principal purchaser and provider groups in one English region were organized around the discussion of three health care purchasing case studies: Coronary artery disease, diabetes and management of clinical depression in general practice. The proceedings were transcribed and analyzed using content analysis methods. Results: 95 people took part. There were major differences between the purchasers' and health care providers' views on the right balance between local and national information and advisory sources for purchasing. In general, providers wanted the provision of advice to purchasers to be local, in which their opinion was sought, either individually or collectively, acted on and the results fed back to them. In contrast, health authority purchasers considered that local professionals were only one source of professional advice, albeit an important one, to be utilized in coming to decisions. General practitioner fundholders as purchasers, however, preferred to rely on their own experiences and contacts with local providers in making purchasing decisions. Conclusions: Professional specialist advisory groups are necessary to inform the purchasing of health care, but should extend beyond advising on the placement of individual contracts. Involving health care providers in all short-term contracting is unlikely to be cost-effective given the time commitment required. The emphasis at purchaser/provider meetings should be on education: Providing an opportunity for purchasers and providers to develop closer relationships to discuss political imperatives and financial constraints; increasing communication and understanding of providers' and purchasers' roles; and providing an environment for professionals and purchasers to share their views on purchasing. As currently presented, elements of the national policies in the NHS advocating the use of both national evidence on clinical effectiveness and local professional advice are contradictory and should be clarified.

scholarly journals Residential transience among US adolescents: association with depression and mental health treatment

2019 ◽  
Vol 28 (6) ◽  
pp. 682-691 ◽  
Author(s):  
C. Glasheen ◽  
V. Forman-Hoffman ◽  
S. Hedden ◽  
T. Ridenour ◽  
J. Wang ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care Providers ◽  
Mental Health Treatment ◽  
Representative Sample ◽  
Care Providers ◽  
Health Treatment ◽  
The Past ◽  
Significant Difference ◽  
Nationally Representative ◽  
To Receive

AbstractAimsResidential instability, including transience (i.e. unusually frequent mobility), is associated with higher risk for emotional and behavioural problems in children and young adults. However, most studies have not compared the effect of recent v. more distal moves on mental health or on mental health treatment. This study examined associations between recent (past year) and distal (past 2–4 years) residential transience and past year major depressive episode (MDE) and mental health treatment in a nationally representative sample of US adolescents aged 12–17.MethodsData are from the 2010–2014 National Surveys on Drug Use and Health (n = ~107 300 adolescents). T-tests were used to examine the prevalence of MDE by number of moves in the past 5 years among a nationally representative sample of adolescents. Additionally, multivariable logistic regression models were used to evaluate the adjusted association between recent (⩾2 moves in the past year) and distal (⩾4 moves in the past 5 years, but no recent transience) and (1) past year MDE and (2) past year mental health treatment among adolescents with MDE.ResultsMDE prevalence increased linearly with number of moves in the past 5 years (p < 0.001). The adjusted odds of MDE were greater among youths with distal transience (adjusted odds ratio (AOR) = 1.25, 95% confidence interval (CI) = 1.09–1.44) and among those with proximal transience (AOR = 1.31, 95% CI = 1.17–1.46), compared with those without transience in the past 5 years. The MDE prevalence did not differ between those with distal and proximal transience (p = 0.163). In youths with past year MDE, the prevalence of past year mental health treatment was greater among those with proximal transience compared with those without transience (AOR = 1.40, 95% CI = 1.15–1.70), but there was no significant difference in treatment among those with distal v. no transience.ConclusionsDistal and recent transience are associated with past year MDE among adolescents. Adolescents with MDE who had recent transience were more likely to receive past year mental health treatment compared with those without transience. However, those with only distal transience were not more likely to receive treatment. Parents, school officials and health care providers should be aware that residential mobility in the past 5 years may indicate increased odds of depression among adolescents even among adolescents whose housing stability has improved in the past year.

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