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Journal of the Neurological Sciences Nov 2022Stroke screening tools should have good diagnostic performance for early diagnosis and a proper therapeutic plan. This paper describes and compares various diagnostic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Stroke screening tools should have good diagnostic performance for early diagnosis and a proper therapeutic plan. This paper describes and compares various diagnostic tools used to identify stroke in emergency departments and prehospital setting.
METHODS
The meta-analysis was conducted according to the Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) guidelines. The PubMed and Scopus databases were searched until December 31, 2021, for studies published on stroke screening tools. These tools' diagnostic performance (sensitivity and specificity) was pooled using a bivariate random-effects model whenever appropriate.
RESULTS
Eleven screening tools for stroke were identified in 29 different studies. The various tools had a wide range of sensitivity and specificity in different studies. In the meta-analysis, the Cincinnati Pre-hospital Stroke Scale, Face Arm Speech Test, and Recognition of Stroke in the Emergency Room (ROSIER) had sensitivity (between 83 and 91%) but poor specificity (all below 64%). When comparing all the tools, ROSIER had the highest sensitivity 90.5%. Los Angeles Pre-hospital Stroke Screen performed best in terms of specificity 88.7% but had low sensitivity (73.9%). Melbourne Ambulance Stroke Screen had a balanced performance in terms of sensitivity (86%) and specificity (76%). Sensitivity analysis consisting of only prospective studies showed a similar range of sensitivity and specificity.
CONCLUSION
All the stroke screening tools included in the review were comparable, but no clear superior screening tool could be identified. Simple screening tools like Cincinnati prehospital stroke scale (CPSS) have similar performance compared to more complex tools.
Topics: Humans; Prospective Studies; Severity of Illness Index; Stroke; Emergency Service, Hospital; Mass Screening; Sensitivity and Specificity; Emergency Medical Services
PubMed: 36201961
DOI: 10.1016/j.jns.2022.120423 -
Journal of Family Psychology : JFP :... Jun 2022Reports an error in "High sensitivity and specificity screening for clinically significant intimate partner violence" by Richard E. Heyman, Katherine J. W. Baucom, Shu...
Reports an error in "High sensitivity and specificity screening for clinically significant intimate partner violence" by Richard E. Heyman, Katherine J. W. Baucom, Shu Xu, Amy M. Smith Slep, Jeffery D. Snarr, Heather M. Foran, Michael F. Lorber, Alexandra K. Wojda and David J. Linkh (, 2021[Feb], Vol 35[1], 80-91). In the article, the affiliation of Heather M. Foran was incorrectly listed as "Family Translational Research Group, New York University." Her correct affiliation is "Institute for Psychology, University of Klagenfurt, and Institute for Psychology, University of Braunschweig." In addition, there were two errors in Table 3 whereby the last row of column 1 should have been labeled "Any of the two items" rather than "Both items," and the final subheading should have read "Female → Male psychological CS-IPV (Male report) rather than "Male → Female psychological CS-IPV (Male report)." Finally, in the Supplemental Material, the second item of the "Screener for Clinically Significant IPV-Psychological" questionnaire should have been deleted. The online version of this article has been corrected. (The following abstract of the original article appeared in record 2020-51524-001). The U.S. Preventive Services Task Force has recommended that clinicians screen patients for intimate partner violence (IPV). This article aims to develop and test the first screeners for clinically significant physical and psychological IPV (i.e., acts meeting criteria in the International Classification of Diseases (11th ed.; ICD-11; World Health Organization, 2019) and the (5th ed.; DSM-5; American Psychiatric Association, 2013). The goal was to derive screeners that (1) are maximally brief, while still achieving high sensitivity and specificity; (2) assess perpetration and victimization when either men or women are reporting; and (3) use ICD-11/ criteria as the reference standard. Random samples of active duty service members at 82 installations worldwide were obtained via e-mail invitation (2006: = 54,543; 2008: = 48,909); their response rates were excellent for long general population surveys with no payment (2006: 44.7%, 2008: 49.0%). The population of spouses at the participating installation was invited by mailed postcard (2006: = 19,722; 2008: = 12,127; response rates-2006: 12.3%, 2008: 10.8%). Clinically significant physical intimate partner violence can be effectively screened with as few as four items, with sensitivities > 90% and specificities > 95%; clinically significant psychological intimate partner violence can be screened with two items. Men and women can be screened with equivalent accuracy, as can those committing the violence and those victimized by it. (PsycInfo Database Record (c) 2022 APA, all rights reserved).
Topics: Bullying; Crime Victims; Female; Humans; Intimate Partner Violence; Male; Mass Screening; Surveys and Questionnaires
PubMed: 35311319
DOI: 10.1037/fam0000974 -
Frontiers in Oncology 2020Quality assured pathology services are integral to provision of optimal management for patients with head and neck cancer. Pathology services vary globally and are... (Review)
Review
Quality assured pathology services are integral to provision of optimal management for patients with head and neck cancer. Pathology services vary globally and are dependent on resources in terms of both laboratory provision and availability of a highly trained and accredited workforce. Ensuring a high-quality pathology service depends largely on close working and effective communication between the clinical team providing treatment and the pathologists providing laboratory input. Laboratory services should be quality assured by achieving external accreditation, most often by conforming to International Organization for Standardization (ISO) standards such as ISO15189 sometimes with ISO17025 or alternatively ISO17020. Quality of diagnostic reporting can be assured by the ISO but clinical teams should endeavor to work with pathologists who engage in continuing professional development, external quality assurance and audit. Research also contributes to diagnostic reporting quality. A number of initiatives in the UK such as the EPSRC/MRC funded Molecular Pathology Nodes and the National Cancer Research Institute Cellular-Molecular Pathology initiative (C-M Path), for example, have linked pathologists, industry and researchers. This has resulted in centers leading in digital innovation, artificial intelligence, translational research and clinical trials supported by pathologists. For rare tumors and contemporary molecular diagnostics, biopsy material can increasingly be shared with expert specialist pathologists working in specialist centers, particularly by using digital pathology platforms with potentially global reach. High quality services for the majority of diagnostic processes required for head and neck cancer management is best provided by local pathologists where communication with the treating team is more effective than with pathologists working in remote centers. Quality assurance is an increasingly important aspect of pathology, assuring not only effective turnaround times and accuracy for the diagnostic service but also high quality consistent reporting for clinical trials where even small pathology errors can potentially produce a significant bias and in the worst case negate the value of a completed trial. Better outcomes have been associated with centers engaged in clinical trials than in non-participating centers. Provision of a quality assured pathology service should extend to both the research and diagnostic services.
PubMed: 32266144
DOI: 10.3389/fonc.2020.00364 -
Biochemistry and Cell Biology =... Dec 2022Direct-to-consumer (DTC) genetic testing is cheaper and more accessible than ever before; however, the intention to combine, reuse, and resell this genetic information...
Direct-to-consumer (DTC) genetic testing is cheaper and more accessible than ever before; however, the intention to combine, reuse, and resell this genetic information as powerful data sets is generally hidden from the consumer. This financial gain is creating a competitive DTC market, reducing the price of whole-genome sequencing (WGS) to under 300 USD. Entering this transition from single-nucleotide polymorphism-based DTC testing to WGS DTC testing, individuals looking for access to their whole-genomic information face new privacy and security risks. Differences between WGS and other methods of consumer genetic tests are left unexplored by regulation, leading to the application of legal data anonymization methods on whole-genome data, and questionable consent methods. Large representative genomic data sets are important for research and improve the standard of medicine and personalized care. However, these data can also be used by market players, law enforcement, and governments for surveillance, population analyses, marketing purposes, and discrimination. Here, we present a summary of the state of WGS DTC genetic testing and its current regulation, through a community-based lens to expose dual-use risks in consumer-facing biotechnologies.
Topics: Humans; Direct-To-Consumer Screening and Testing; Genetic Testing; Genomics; Risk Assessment
PubMed: 35939839
DOI: 10.1139/bcb-2021-0506 -
International Journal of Laboratory... Apr 2024This paper is a report of an ICSH review of policies and practices for internal quality control (IQC) policy for haematology cell counters among regulatory bodies, cell... (Review)
Review
INTRODUCTION
This paper is a report of an ICSH review of policies and practices for internal quality control (IQC) policy for haematology cell counters among regulatory bodies, cell counter manufacturers and diagnostic laboratories. It includes a discussion of the study findings and links to separate ICSH guidance for such policies and practices. The application of internal quality control (IQC) methods is an essential pre-requisite for all clinical laboratory testing including the blood count (Full Blood Count, FBC, or Complete Blood Count, CBC).
METHODS
The ICSH has gathered information regarding the current state of practice through review of published guidance from regulatory bodies, a questionnaire to six major cell counter manufacturers (Abbott Diagnostics, Beckman Coulter, Horiba Medical Diagnostic Instruments & Systems, Mindray Medical International, Siemens Healthcare Diagnostics and Sysmex Corporation) and a survey issued to 191 diagnostic laboratories in four countries (China, Republic of Ireland, Spain and the United Kingdom) on their IQC practice and approach to use of commercial IQC materials.
RESULTS
This has revealed diversity both in guidance and in practice around the world. There is diversity in guidance from regulatory organizations in regard to IQC methods each recommends, clinical levels to use and frequency to run commercial controls, and finally recommended sources of commercial controls. The diversity in practice among clinical laboratories spans the areas of IQC methods used, derivation of target values and action limits used with control materials, and frequency of running commercial controls materials.
CONCLUSIONS
These findings and their implications for IQC Practice are discussed in this paper. They are used to inform a separate guidance document, which proposes a harmonized approach to address the issues faced by diagnostic laboratories.
Topics: Humans; Quality Control; Laboratories; Blood Cells; Clinical Laboratory Services; Clinical Laboratory Techniques
PubMed: 38214063
DOI: 10.1111/ijlh.14220 -
European Journal of Human Genetics :... Dec 2022Direct-to-consumer genetic testing (DTC-GT) is becoming increasingly widespread. The aim of this research was to systematically review the literature published on... (Review)
Review
Direct-to-consumer genetic testing (DTC-GT) is becoming increasingly widespread. The aim of this research was to systematically review the literature published on healthcare professionals' knowledge and views about DTC-GT, as an update to a 2012 systematic review. The secondary aim was to assess the knowledge and views of healthcare professionals on the ethical and legal issues pertaining to DTC-GT. A systematic search was performed to identify all relevant studies that have been conducted since 2012. Studies fulfilled the inclusion criteria if they were primary research papers conducted on healthcare professionals about their knowledge and views on health-related DTC-GT. PubMed, Embase, CINAHL, PsycINFO and Medline databases were searched from 2012 to May 2021. Title and abstract were screened, and full texts were reviewed by two study authors independently. New papers included were appraised and data were extracted on study characteristics, knowledge and views on DTC-GT, and ethical and legal issues. A narrative synthesis was conducted. Nineteen new papers were included, along with eight papers from the previous review. There was considerable variation in study participants with differing views, awareness levels, and levels of knowledge about DTC-GT. Genetic counsellors and clinical geneticists generally had more concerns, experience, and knowledge regarding DTC-GT. Ten ethical concerns and four legal concerns were identified. Healthcare professionals' knowledge and experience of DTC-GT, including awareness of DTC-GT ethical and legal concerns, have only minimally improved since the previous review. This emphasises the need for further medical learning opportunities to improve the gaps in knowledge amongst healthcare professionals about DTC-GT.
Topics: Humans; Delivery of Health Care; Direct-To-Consumer Screening and Testing; Genetic Testing; Health Personnel; Morals
PubMed: 36220915
DOI: 10.1038/s41431-022-01205-8 -
Journal of Clinical Virology : the... Aug 2021In 2018, a bi-partisan proposed draft legislation called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was released by Representative Larry Bucshon... (Review)
Review
In 2018, a bi-partisan proposed draft legislation called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act was released by Representative Larry Bucshon (Republican-Indiana) and Diana DeGette, (Democrat-Colorado). The VALID Act attempts to create a new framework for the oversight and regulations of both laboratory-developed testing procedures (commonly known as laboratory-developed tests) and In vitro diagnostic tests by the U.S. Food and Drug Administration. The potential impact of this new law if passed may be significant for clinical laboratories in terms of diagnostic test development and implementation. In this report, we review the background and key information that every clinical virologist should know about the VALID Act.
Topics: Clinical Laboratory Services; Colorado; Diagnostic Tests, Routine; Humans; Laboratories; United States; United States Food and Drug Administration
PubMed: 34243115
DOI: 10.1016/j.jcv.2021.104875 -
The Australian Journal of Rural Health Jun 2020To describe the characteristics of patients who used the Royal Flying Doctor Service dental clinics and determine Royal Flying Doctor Service and non-Royal Flying Doctor...
OBJECTIVE
To describe the characteristics of patients who used the Royal Flying Doctor Service dental clinics and determine Royal Flying Doctor Service and non-Royal Flying Doctor Service dental service provision in mainland Australia.
DESIGN
A prospective cohort study.
SETTING
All Royal Flying Doctor Service dental clinics located throughout rural and remote Australia.
PARTICIPANTS
All patients who accessed an Royal Flying Doctor Service dental clinic from April 2017 to September 2018.
INTERVENTIONS
Royal Flying Doctor Service mobile dental clinics.
MAIN OUTCOME MEASURES
Patient demographics and dental procedures conducted (by age, sex and Indigenous status); and the dental service provision and coverage (Royal Flying Doctor Service and non-Royal Flying Doctor Service) within mainland rural and remote Australia.
RESULTS
There were 8992 patient episodes comprising 3407 individual patients with 27 897 services completed. There were 920 (27%) Indigenous and 1465 (43%) non-Indigenous patients (n = 1022 missing ethnicity data). The mean (SD) age was 31.5 (24.8) years; the age groups 5-9 years and 10-14 years received 17.6% and 15.1% of the services, respectively. There were 1124 (33%) men and 1295 (38%) women (n = 988 with missing sex data). Women were more likely (all P < .05) to receive preventive services, diagnostic services, restorative services, general services, endodontics and periodontics. Men were more likely (both P < .05) to receive oral surgery and prosthodontics. There are many rural and remote people required to travel more than 60 minutes by vehicle to access dental care.
CONCLUSION
Without increasing dental provision and preventive services in rural areas, it seems likely that there are and will be unnecessary oral emergencies and hospitalisations.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aircraft; Australia; Child; Child, Preschool; Cohort Studies; Delivery of Health Care; Dental Care; Dental Clinics; Female; Humans; Infant; Male; Middle Aged; Mobile Health Units; Prospective Studies; Rural Population
PubMed: 32462697
DOI: 10.1111/ajr.12631 -
Journal of Hematopathology Jun 2023The International Consensus Classification (ICC) and World Health Organization (WHO) proposed significant changes to the diagnostic criteria of myelodysplastic syndromes...
The International Consensus Classification (ICC) and World Health Organization (WHO) proposed significant changes to the diagnostic criteria of myelodysplastic syndromes (MDS) in 2022. The impact of these criteria on hematopathology practice is uncertain. This study aims to evaluate the impact of the 2022 ICC and WHO 5th edition classifications on the diagnosis of cytopenias and MDS. Cases from 2021 performed for primary diagnosis of cytopenia(s)/MDS and their clinical, laboratory, and pathologic findings were reviewed and classified according to the new classification systems. The rate of major changes to the diagnosis was determined and potential pitfalls in the diagnostic approach, laboratory workflow, and clinical communication challenges were investigated. A total of 49 cases were recruited. Major changes to the diagnostic entities were made in 18/49 (37%) cases according to the WHO 5th edition, and 23/49 (47%) cases classified according to the ICC. The difference was accounted for by five cases of MDS-EB2 (revised WHO 4th edition) classified as MDS/AML (major change) in the ICC in contrast to no significant change (MDS-IB2) in the WHO 5th edition. MDS-SLD cases were not subject to major reclassification according to either system. The new molecularly defined categories of CCUS/CHIP, MDS-SF3B1, and MDS with biallelic TP53 mutations were almost identically represented in both systems in our cohort. A case of MDS-MLD was reclassified as CMML by both classification systems. There are few but important differences between the new MDS classification systems. A preimplementation assessment is helpful to identify diagnostic and potential clinical impacts of their adoption.
Topics: Humans; Laboratories, Clinical; Consensus; Clinical Laboratory Services; Cytopenia; Myelodysplastic Syndromes; World Health Organization
PubMed: 38175439
DOI: 10.1007/s12308-023-00538-7 -
Pediatrics Mar 2020Next-generation sequencing has revolutionized the diagnostic process, making broadscale testing affordable and applicable to almost all specialties; however, there...
Next-generation sequencing has revolutionized the diagnostic process, making broadscale testing affordable and applicable to almost all specialties; however, there remain several challenges in its widespread implementation. Barriers such as lack of infrastructure or expertise within local health systems and complex result interpretation or counseling make it harder for frontline clinicians to incorporate genomic testing in their existing workflow. The general population is more informed and interested in pursuing genetic testing, and this has been coupled with the increasing accessibility of direct-to-consumer testing. As a result of these changes, primary care physicians and nongenetics specialty providers find themselves seeing patients for whom genetic testing would be beneficial but managing genetic test results that are out of their scope of practice. In this report, we present a practical and centralized approach to providing genomic services through an independent, enterprise-wide clinical service model. We present 4 years of clinical experience, with >3400 referrals, toward designing and implementing the clinical service, maximizing resources, identifying barriers, and improving patient care. We provide a framework that can be implemented at other institutions to support and integrate genomic services across the enterprise.
Topics: Child; Delivery of Health Care; Genetic Testing; Genomics; Humans; Pediatrics
PubMed: 32102930
DOI: 10.1542/peds.2019-0855