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Asia-Pacific Journal of Ophthalmology... 2019Retinopathy of prematurity (ROP) is a leading cause of preventable childhood blindness worldwide. Barriers to ROP screening and difficulties with subsequent evaluation... (Review)
Review
Retinopathy of prematurity (ROP) is a leading cause of preventable childhood blindness worldwide. Barriers to ROP screening and difficulties with subsequent evaluation and management include poor access to care, lack of physicians trained in ROP, and issues with objective documentation. Digital retinal imaging can help address these barriers and improve our knowledge of the pathophysiology of the disease. Advancements in technology have led to new, non-mydriatic and mydriatic cameras with wider fields of view as well as devices that can simultaneously incorporate fluorescein angiography, optical coherence tomography (OCT), and OCT angiography. Image analysis in ROP is also being employed through smartphones and computer-based software. Telemedicine programs in the United States and worldwide have utilized imaging to extend ROP screening to infants in remote areas and have shown that digital retinal imaging can be reliable, accurate, and cost-effective. In addition, tele-education programs are also using digital retinal images to increase the number of healthcare providers trained in ROP. Although indirect ophthalmoscopy is still an important skill for screening, digital retinal imaging holds promise for more widespread screening and management of ROP.
Topics: Health Services Accessibility; Humans; Image Processing, Computer-Assisted; Infant, Newborn; Neonatal Screening; Ophthalmoscopy; Reproducibility of Results; Retinopathy of Prematurity; Telemedicine; Tomography, Optical Coherence
PubMed: 31037876
DOI: 10.22608/APO.201963 -
American Journal of Clinical Pathology Jul 2019To provide a clinical laboratory perspective on the Verifying Accurate Leading-edge IVCT Development Act (VALID) discussion draft. This potential legislative effort, if... (Review)
Review
OBJECTIVES
To provide a clinical laboratory perspective on the Verifying Accurate Leading-edge IVCT Development Act (VALID) discussion draft. This potential legislative effort, if enacted, would overhaul the regulatory oversight of in vitro diagnostics (IVDs) in the United States and create a single system for regulation of conventional IVDs and laboratory-developed tests (LDTs).
METHODS
A concise literature-based review of LDT regulation is presented followed by a discussion of key concerns pertinent to clinical laboratories that should be considered in future IVD regulatory reform efforts.
RESULTS
Key issues identified include the importance of fostering innovation, preserving patient safety, protecting the practice of laboratory medicine, and minimizing undue regulatory burden. Clinical laboratories are not equivalent to manufacturing facilities and would therefore encounter challenges in implementing device-centric regulatory oversight models.
CONCLUSIONS
It is imperative that a clinical laboratory perspective on LDTs is understood and incorporated prior to advancement of future legislative proposals.
Topics: Clinical Laboratory Services; Diagnostic Tests, Routine; Humans; United States; United States Food and Drug Administration
PubMed: 31242284
DOI: 10.1093/ajcp/aqz096 -
Diagnosis (Berlin, Germany) Jun 2018Laboratory services around the world are undergoing substantial consolidation and changes through mechanisms ranging from mergers, acquisitions and outsourcing,... (Review)
Review
Laboratory services around the world are undergoing substantial consolidation and changes through mechanisms ranging from mergers, acquisitions and outsourcing, primarily based on expectations to improve efficiency, increasing volumes and reducing the cost per test. However, the relationship between volume and costs is not linear and numerous variables influence the end cost per test. In particular, the relationship between volumes and costs does not span the entire platter of clinical laboratories: high costs are associated with low volumes up to a threshold of 1 million test per year. Over this threshold, there is no linear association between volumes and costs, as laboratory organization rather than test volume more significantly affects the final costs. Currently, data on laboratory errors and associated diagnostic errors and risk for patient harm emphasize the need for a paradigmatic shift: from a focus on volumes and efficiency to a patient-centered vision restoring the nature of laboratory services as an integral part of the diagnostic and therapy process. Process and outcome quality indicators are effective tools to measure and improve laboratory services, by stimulating a competition based on intra- and extra-analytical performance specifications, intermediate outcomes and customer satisfaction. Rather than competing with economic value, clinical laboratories should adopt a strategy based on a set of harmonized quality indicators and performance specifications, active laboratory stewardship, and improved patient safety.
Topics: Clinical Laboratory Services; Clinical Laboratory Techniques; Commerce; Diagnostic Errors; Health Facility Merger; Humans; Outcome Assessment, Health Care; Quality Indicators, Health Care
PubMed: 29813029
DOI: 10.1515/dx-2018-0019 -
Deutsches Arzteblatt International Feb 2023
Topics: Humans; Infant, Newborn; Neonatal Screening; Hearing; Mass Screening
PubMed: 37005719
DOI: 10.3238/arztebl.m2022.0269 -
The Lancet. Global Health Nov 2021
Topics: Delivery of Health Care; Diagnostic Services; Drugs, Essential; Guidelines as Topic; Humans; World Health Organization
PubMed: 34678179
DOI: 10.1016/S2214-109X(21)00467-8 -
International Journal of Laboratory... Jun 2023Contemporary full spectrum or "spectral" flow cytometry is a recently developed technology that allows for high-dimensional flow cytometric analyses of cells and... (Review)
Review
Contemporary full spectrum or "spectral" flow cytometry is a recently developed technology that allows for high-dimensional flow cytometric analyses of cells and particles in suspension. This single-cell technology has gained popularity in research settings because it can conservatively detect 35 or more antigens simultaneously in a single-tube assay format. Recently, spectral flow cytometry has obtained regulatory approval for use as an in vitro diagnostic device in China and Europe, enabling use of this technology in some clinical flow cytometry laboratories. The purpose of this review is to describe the basic principles of conventional and spectral flow cytometry, contrasting these two technologies. To illustrate the analytic power of spectral flow cytometry, we provide an example of spectral flow cytometry data analyses and the use of a machine learning algorithm to harvest the vast amount of information contained within large spectral flow cytometry datasets. Finally, we discuss the advantages of spectral flow cytometry adoption in clinical laboratories and preliminary studies comparing the performance of this technology relative to conventional flow cytometers that are currently used in clinical laboratory environments.
Topics: Humans; Flow Cytometry; Laboratories, Clinical; Clinical Laboratory Services; Algorithms; Europe
PubMed: 37211417
DOI: 10.1111/ijlh.14098 -
European Journal of Human Genetics :... Jul 2023The UK National Diagnostic Service for Ehlers-Danlos Syndromes (EDS) was established in 2009 for the rare types of EDS. Vascular EDS (vEDS) is an inherited connective... (Review)
Review
The UK National Diagnostic Service for Ehlers-Danlos Syndromes (EDS) was established in 2009 for the rare types of EDS. Vascular EDS (vEDS) is an inherited connective tissue disorder caused by pathogenic variants in the COL3A1 gene. Associated tissue fragility affects multiple organ systems, increasing the risk of blood vessel dissection and rupture, with potentially fatal consequences. The diagnosis of vEDS has improved with advances in genetic testing, however this is most often suspected following an acute event. We provide data on the clinical features of vEDS for 180 patients (full cohort) seen in our service with confirmed molecular diagnoses. Increased awareness of this rare condition will prompt genetic testing essential to confirm the diagnosis. Outcomes are improved by early diagnosis followed by appropriate management. Fragile connective tissues make invasive procedures potentially dangerous, particularly in an emergency setting. Lifestyle advice from a young age can help acceptance and understanding of the diagnosis and inform choices. There is currently limited evidence for the use of drug therapy to reduce vascular events. We report on the incidence of vascular events in 126 patients (statistical analysis cohort) in our care and the use of medication. Our retrospective data showed that those patients on a long-term angiotensin II receptor blocker and/or beta-blocker had fewer vascular events than those not on cardiac medication who received the same lifestyle and emergency care advice.
Topics: Humans; Ehlers-Danlos Syndrome, Type IV; Retrospective Studies; Ehlers-Danlos Syndrome; Genetic Testing; United Kingdom; Collagen Type III
PubMed: 36977837
DOI: 10.1038/s41431-023-01343-7 -
Infectious Diseases of Poverty Feb 2020Diagnostics are essential for identifying and controlling diseases. However, limited access to diagnostics hinders public health efforts in many settings. Social... (Review)
Review
BACKGROUND
Diagnostics are essential for identifying and controlling diseases. However, limited access to diagnostics hinders public health efforts in many settings. Social innovation may provide a framework for expanding access to diagnostics in the global south. Here social innovation is defined as implementing a known public health tool via a novel, community-driven technique.
MAIN BODY
In this article, we discuss three diverse cases that show the potential for using social innovation in diagnostics. The cases chosen for inclusion here demonstrate the importance of social innovation in diagnostics across different geographic, cultural, and health system contexts. They include malaria testing via schools in Malawi, cervical human papillomavirus (HPV) sample self-collection in Peru, and crowdsourcing human immunodeficiency virus (HIV) testing in China. For each case, we present the public health problem and the impact of using social innovation to increase accessibility of diagnostics. We discuss implications of each diagnostic approach and the importance of social innovation in creating these potential solutions. We argue that social innovation is useful in improving the delivery of essential diagnostic tools in low- and middle-income countries.
CONCLUSIONS
Interventions in Malawi, Peru, and China suggest social innovation increases uptake of diagnostics. The same tools and principles utilized in these cases can be adapted for use in other contexts. Such diagnostic innovations may help improve identification of and linkage to care for many diseases. The approach presents a unique opportunity to better address public health issues and increase accessibility in LMIC health systems.
Topics: Diagnostic Services; Humans; Organizational Innovation; Public Health
PubMed: 32070433
DOI: 10.1186/s40249-020-0633-6 -
Bulletin of the World Health... Jun 2023To implement and evaluate a large-scale online cervical cancer screening programme in Hubei Province, China, supported by artificial intelligence and delivered by...
OBJECTIVE
To implement and evaluate a large-scale online cervical cancer screening programme in Hubei Province, China, supported by artificial intelligence and delivered by trained health workers.
METHODS
The screening programme, which started in 2017, used four types of health worker: sampling health workers, slide preparation technicians, diagnostic health workers and cytopathologists. Sampling health workers took samples from the women on site; slide preparation technicians prepared slides for liquid-based cytology; diagnostic health workers identified negative samples and classified positive samples based on the Bethesda System after cytological assessment using online artificial intelligence; and cytopathologists reviewed positive samples and signed reports of the results online. The programme used fully automated scanners, online artificial intelligence, an online screening management platform, and mobile telephone devices to provide screening services. We evaluated the sustainability, performance and cost of the programme.
RESULTS
From 2017 to 2021, 1 518 972 women in 16 cities in Hubei Province participated in the programme, of whom 1 474 788 (97.09%) had valid samples for the screening. Of the 86 648 women whose samples were positive, 30 486 required a biopsy but only 19 495 had one. The biopsy showed that 2785 women had precancerous lesions and 191 had invasive cancers. The cost of screening was 6.31 United States dollars (US$) per woman for the public payer: US$ 1.03 administrative costs and US$ 5.28 online screening costs.
CONCLUSION
Cervical cancer screening using artificial intelligence in Hubei Province provided a low-cost, accessible and effective service, which will contribute to achieving universal cervical cancer screening coverage in China.
Topics: Female; Humans; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Vaginal Smears; Early Detection of Cancer; Artificial Intelligence; China; Mass Screening
PubMed: 37265676
DOI: 10.2471/BLT.22.289061 -
Molecular Genetics & Genomic Medicine Jun 2019The completion of the Human Genome Project in 2003 heralded in a new era marked by remarkable advances in biomedical research leading to the establishment of... (Review)
Review
The completion of the Human Genome Project in 2003 heralded in a new era marked by remarkable advances in biomedical research leading to the establishment of genomics-based translational medicine mainly in the developed world. However, the development of such advances has been hampered in most parts of the developing world due to scarcity of resources and trained personnel. Genetics and genomic medicine are currently in the process of being integrated into the Sri Lankan health care system. These developments have taken place mainly due to the heightened awareness and increasing demands made by the public for provision of genetic diagnostic and therapeutic services in clinical care. Due to the exorbitant costs incurred in the maintenance of these services and the dearth of adequately trained manpower, only a few centers in the country, mainly in Universities or private sector, are currently engaged in providing these services to the public. This article aims to provide an overview of the genetics and genomic medicine services in Sri Lanka from its early developments to the current state.
Topics: Facilities and Services Utilization; Genetic Diseases, Inborn; Genetic Testing; Genetics, Medical; Humans; Sri Lanka
PubMed: 31106988
DOI: 10.1002/mgg3.744