Accuracy of periocular lesion assessment using telemedicine.

OBJECTIVES: To assess the agreement in diagnosis and management plans reached between clinicians reviewing eyelid lesions remotely and in face-to-face clinics. METHODS: In this single-centre observational case series, data were prospectively collected on 50 consecutive adults referred with eyelid lesions suitable to be seen by a nurse. A proforma was completed to gather salient information. A nurse specialist saw patients in face-to-face clinics and collected information using the proforma, devising a diagnosis and management plan. Photographs of the eyelid lesions were taken by a medical photographer. A subsequent remote review was completed by an oculoplastic consultant using the proforma information and photographs in the absence of the patient. The diagnosis and management plan constructed by the nurse specialist were compared with those reached by the consultant. RESULTS: Complete data were available for 44 consecutive cases. There was an overall 91% agreement (40 cases out of 44) between the diagnoses reached by the nurse specialist, and the remote reviewer; kappa coefficient 0.88 (95% CI 0.76 to 0.99). There was an overall 82% agreement (36 out of 44 cases) in the management plans devised by the nurse-led clinic and remote reviewer; kappa coefficient 0.74 (95% CI 0.58 to 0.90). The average time taken for a remote reviewer to reach a diagnosis and management plan was 1 min and 20 s. CONCLUSIONS: This study evaluated the feasibility of assessing eyelid lesions using asynchronous telemedicine. There was overall a high rate of concordance in the diagnosis reached, and management devised between the clinic and remote review.

Real-Life Incentives Driving Public-Private Partnership in Diagnostic Services.

BACKGROUND: Diagnostic services are highly critical in the success of treatment processes, overly costly nonetheless. Accordingly, hospitals generally seek the private partnership in the provision of such services. This study intends to explore the incentives owned by both public and private sector in their joint provision of diagnostic services under the public-private partnership agreement. METHOD: A qualitative, exploratory study was employed in Tehran hospitals from October 2017 to March 2018. Around 25 face-to-face, semi-structured interviews were conducted with the purposively recruited hospital managers, heads of diagnostic services and managers of private companies. Interviews were transcribed and analyzed using conventional content analysis, assisted by "MAXQDA-12". RESULTS: Three main categories and nine sub-categories represented the incentives of public sector, and four main categories and seven sub-categories signified those of private sector. The incentives of public sector included the status-quo remediation, upstream requirements, and personal reasons. As such, the individual, social and economic incentives and legal constraints were driving the behavior of the private sector. CONCLUSIONS: Financial problem and gain were the most noted incentives by the partners. Attention to the either side's incentives and aims is likely to ensure the durability and effectiveness of such partnerships in the health sector.

My Experience with SARS-CoV-2, with a Focus on Testing.

Testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) got off to a slow start in the United States. In this commentary, I describe my experience with CoV disease 2019 (COVID-19), with a focus on being tested at the University of North Carolina-Chapel Hill Respiratory Diagnostic Center on its inaugural day.

The First Quarter of SARS-CoV-2 Testing: the University of Washington Medicine Experience.

In early March 2020, the University of Washington Medical Center clinical virology laboratory became one of the first clinical laboratories to offer testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). When we first began test development in mid-January, neither of us believed there would be more than 2 million confirmed SARS-CoV-2 infections nationwide or that we would have performed more than 150,000 real-time PCR (RT-PCR) tests, with many more to come. This article will be a chronological summary of how we rapidly validated tests for SARS-CoV-2, increased our testing capacity, and addressed the many problems that came up along the way.

The importance of intra- and inter-institutional networks for capacity building in severe acute respiratory syndrome coronavirus 2 reverse transcription polymerase chain reaction services: experience from an oncology centre in eastern India.

High-throughput, accurate, cost-effective and rapid testing for severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) is the need of the hour in face of the global coronavirus disease pandemic. This target is achievable, within a relatively short time through capacity building of reverse transcription polymerase chain reaction (RT-PCR) tests by utilising the strengths of intra and inter institutional networks. These networks act as force multiplier for vital resources which are required for capacity building, namely, leadership, expertise, equipment, space, infection control inputs and human resources. In this article, we report the experience of capacity building for delivery of RT-PCR tests for SARS CoV-2 from a cancer hospital in Eastern India. The relevance, mode of operation and value addition of this essential public health service are discussed in the context of inter departmental collaboration and interaction with other institutes through the existing diagnostic, surveillance and infection control networks. This networking model for service development and delivery could be used by other centres.

A Public Health Laboratory Response to the Pandemic.

An outbreak of coronavirus disease 2019 (COVID-19) caused by a novel coronavirus (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]) began in Wuhan, Hubei, China, in December 2019 and spread rapidly worldwide. The response by the Alberta Precision Laboratories, Public Health Laboratory (ProvLab), AB, Canada, included the development and implementation of nucleic acid detection-based assays and dynamic changes in testing protocols for the identification of cases as the epidemic curve increased exponentially. This rapid response was essential to slow down and contain transmission and provide valuable time to the local health authorities to prepare appropriate response strategies. As of May 24, 2020, 236,077 specimens were tested, with 6,475 (2.74%) positives detected in the province of Alberta, Canada. Several commercial assays are now available; however, the response from commercial vendors to develop and market validated tests is a time-consuming process. In addition, the massive global demand made it difficult to secure a reliable commercial supply of testing kits and reagents. A public health laboratory serves a unique and important role in the delivery of health care. One of its functions is to anticipate and prepare for novel emerging pathogens with a plan for pandemic preparedness. Here, we outline the response that involved the development and deployment of testing methodologies that evolved as SARS-CoV-2 spread worldwide, the challenges encountered, and mitigation strategies. We also provide insight into the organizational structure of how a public health response is coordinated in Alberta, Canada, and its benefits.

Tuberculosis, HIV, and viral hepatitis diagnostics in eastern Europe and central Asia: high time for integrated and people-centred services.

Globally, high rates (and in the WHO European region an increasing prevalence) of co-infection with tuberculosis and HIV and HIV and hepatitis C virus exist. In eastern European and central Asian countries, the tuberculosis, HIV, and viral hepatitis programmes, including diagnostic services, are separate vertical structures. In this Personal View, we consider underlying reasons for the poor integration for these diseases, particularly in the WHO European region, and how to address this with an initial focus on diagnostic services. In part, this low integration has reflected different diagnostic development histories, global funding sources, and sample types used for diagnosis (eg, typically sputum for tuberculosis and blood for HIV and hepatitis C). Cooperation between services improved as patients with tuberculosis needed routine testing for HIV and vice versa, but financial, infection control, and logistical barriers remain. Multidisease diagnostic platforms exist, but to be used optimally, appropriate staff training and sensible understanding of different laboratory and infection control risks needs rapid implementation. Technically these ideas are all feasible. Poor coordination between these vertical systems remains unhelpful. There is a need to increase political and operational integration of diagnostic and treatment services and bring them closer to patients.

Point-of-care testing by healthcare workers for detection of meticillin-resistant Staphylococcus aureus, Clostridioides difficile, and norovirus.

BACKGROUND: The feasibility of introducing three separate Cepheid GeneXpert® assays was assessed: Xpert SA Nasal Complete, Xpert C. difficile, and Xpert Norovirus for point-of-care testing (POCT) on a ward in a district general hospital. AIM: To establish a seven-day/24 h POCT service for meticillin-resistant Staphylococcus aureus (MRSA), Clostridioides difficile, and norovirus operated solely by healthcare workers (HCWs). METHODS: The Cepheid GeneXpert assays performance characteristics were assessed by comparing the assays to traditional central laboratory methods in terms of clinical turnaround times, hands-on time, number of process steps, time to result and diagnostic accuracy. HCW feedback was collected to consider the potential added value of applying this technology to improve patient flow and clinical care. FINDINGS: In total 1170 tests were carried out over the 16-month study period. The assays significantly reduced hands-on time, process steps, and time to result for identification of all three micro-organisms. Overall agreement with central laboratory testing was >98% for all three assays. Staff members fed back that POCT had a positive impact in terms of clinical utility. CONCLUSION: Xpert SA Nasal Complete for MRSA detection, Xpert C. difficile, and Xpert Norovirus can be used as POCT solely by HCWs in a ward setting. Each assay was used throughout a seven-day/24 h period with potential positive impact on bed management and patient care.

Access to Comprehensive Services for Advanced Liver Disease in the Veterans Health Administration.

BACKGROUND: The Veterans Health Administration (VHA) provides care to the one of the largest cohorts of patients with advanced liver disease (ALD) in the USA. AIMS: We performed a national survey to assess system-wide strengths and barriers to care for Veterans with ALD in this national integrated healthcare setting. METHODS: A 52-item survey was developed to assess access and barriers to care in Veterans with ALD. The survey was distributed to all VHA medical centers in 2015. Results were analyzed using descriptive statistics. RESULTS: One hundred and fifty-three sites responded to this survey. Multidisciplinary services were available on-site at > 80% of sites. Ninety-five percent of sites had mental health and addictions treatment available, with 14% co-locating these services within the liver clinic. Few sites (< 25%) provided pharmacologic treatment for alcohol use disorder in primary care or hepatology settings. Seventy-two percent of sites reported at least one barrier to liver-related care. Of the sites reporting at least one barrier, 53% reported barriers to liver transplant referral, citing complex processes and lack of staff/resources to coordinate referrals. Palliative care was widely available, but 61% of sites reported referring < 25% of their patients with ALD for palliative services. CONCLUSION: Multidisciplinary services for Veterans with ALD are widely available at VHA sites, though barriers to optimal care remain. Opportunities for improvement include the expansion of providers with hepatology expertise, integrating pharmacotherapy for alcohol use disorder into hepatology and primary care, streamlining the transplant referral process, and expanding palliative care referrals for patients with ALD.

Interdependence of diagnostics and epidemiology, a European perspective: Position paper on the need for an intrinsic cooperation and data sharing.

For some well-known pathogens like influenza or RSV, diagnostic and epidemiological data is available and continuously complement each other. For most other pathogens however, data is not always available or severely delayed. Furthermore, clinical data is needed to assess the burden of disease, which will enhance awareness and help to gain knowledge on emerging pathogens. In this position paper, we discuss the interdependence of diagnostics and epidemiology from a European perspective. In 2004, the European Centre for Disease Prevention and Control (ECDC) was founded to coordinate European wide surveillance and control. At present however, the ECDC still relies on university hospitals, public health institutions and other diagnostic institutions. Close collaboration between all stakeholders across Europe is therefore complex, but necessary to optimize the system for the individual patient. From the diagnostic side, data on detected pathogens should be shared with relevant health institutions in real-time. From the public health side, collected information should be made accessible for diagnostic and clinical institutions in real-time. Subsequently, this information needs to be disseminated across relevant medical disciplines to reach its full potential.

A fetal alcohol spectrum disorder diagnostic service and beyond: Outcomes for families.

BACKGROUND: Fetal alcohol spectrum disorder (FASD) is of significant concern for Australians for many reasons, one being Australia's drinking culture which increases the potential for FASD to occur. AIMS: The current study aimed to explore the lived experiences of Australian caregivers who received a FASD diagnosis for a child in their care, usingthe Australian Guide to the Diagnosis of FASD. METHODS AND PROCEDURES: Semi-structured interviews were conducted with seven caregivers whose children were assessed for FASD by a multidisciplinary team. Interviews explored how families experienced the FASD diagnostic process, and sought insight into outcomes for families following diagnosis, particularly in relation to accessing supports and services. OUTCOMES AND RESULTS: Through thematic analysis, five overarching themes were identified: (1) receiving a FASD diagnosis had a positive impact; (2) caregivers' evaluation of assessment process; (3) positive support services relative to FASD; (4) ongoing difficulties regardless of diagnosis; and (5) need for societal knowledge of FASD. CONCLUSIONS AND IMPLICATIONS: Given the global need for standardised FASD diagnostic procedures and accurate reporting of prevalence rates, the current study provides a contribution to the emerging diagnostic FASD literature, and insight into families' experiences who have children diagnosed with FASD. WHAT THIS PAPER ADDS: This study provides additional information to the developing pool of literature attempting to create a typical profile of FASD. Most importantly, this paper highlights the implementation of the Australian Guide to the Diagnosis of FASD, and evaluates caregivers' experiences of their child's FASD assessment process, within a public FASD diagnostic service, using the revised guidelines.

Uptake of peer-led venue-based HIV testing sites in Sweden aimed at men who have sex with men (MSM) and trans persons: a cross-sectional survey.

OBJECTIVES: HIV testing among high-risk groups is a key intervention to diagnose persons living unknowingly with HIV to enable linkage to care and effective antiretroviral treatment. This study aimed to evaluate the uptake of Testpoint, the first large-scale HIV testing programme in Sweden where peer, non-healthcare personnel offered venue-based testing. Testing was performed by staff from the Swedish Foundation for Lesbian, Gay, Bisexual and Transgender Rights (RFSL Sweden) and testing was performed at the RFSL offices, gay clubs and gay cruising areas, as well as at various gay festivals. The test was a rapid test using capillary blood from a finger prick. METHODS: A cross-sectional survey of all persons aged >18 years who came for HIV testing at one of Testpoint's locations in Sweden between 1 February and 31 December 2016. RESULTS: 595 respondents (96% response rate) were included. Five persons were diagnosed with HIV and referred for treatment and care. A fifth of participants had never tested for HIV before. More than half of the participants were foreign born and the median age was 31 years. About one-fifth of participants stated they would not have tested through the healthcare system if Testpoint was not available. CONCLUSIONS: Testpoint reached their target population of young, foreign-born men who have sex with men (MSM) as well as first time testers and persons who stated that they would not have tested within the healthcare system. Such peer HIV testing outside the healthcare setting is a possible way of increasing uptake of testing in high-risk groups.

What is needed now for successful scale-up of screening?

Effective screening for pre-cancerous lesions of the cervix is the only protective intervention that can be offered to women that have not had the opportunity to be vaccinated. Elimination goals are being developed so that by 2030, 70% of women aged 35-45 years should have been screened at least once in a lifetime and 90% of all detected lesions should have been treated. These goals focus on a substantial reduction of cervical cancer burden in low- and middle-income countries (LMICs). Scaling-up screening in these settings may be substantially improved by using self-sampling (SS), human papillomavirus (HPV) testing, and managing screened-positive women with accessible treatment. The implementation of these tools requires minimal health information data for traceability, provider training, community education, operational management and quality control. Cost-effective algorithms tailored to country needs can greatly impact the burden of disease in a limited number of years.

Community based distribution of oral HIV self-testing kits in Zambia: a cluster-randomised trial nested in four HPTN 071 (PopART) intervention communities.

BACKGROUND: The HPTN 071 (PopART) cluster-randomised trial provided door-to-door HIV testing services to a large proportion of individuals residing in 21 intervention communities in Zambia and South Africa from 2014 to 2017 and reached the UNAIDS first 90 target among women in Zambia, yet gaps remained among men and young adults. This cluster-randomised study nested in the HPTN 071 (PopART) trial sought to increase knowledge of HIV status across all groups by offering the choice of oral HIV self-testing in addition to routine door-to-door HIV testing services. METHODS: We nested this cluster-randomised trial in four HTPN 071 (PopART) intervention communities in northern Zambia. 66 zones (clusters) in these communities were randomly allocated (1:1) to either oral HIV self-testing plus routine door-to-door HIV testing services (HIV self-testing group) or the PopART standard of care of door-to-door HIV testing services alone (non- HIV self-testing group) over a 3-month period. All individuals aged 16 years or older were eligible for HIV testing. Randomisation was achieved by randomly selecting one allocation from a list of 10 000 possible allocations during a public ceremony. In HIV self-testing zones, trained lay-counsellors (known as community HIV care providers) visited households and offered eligible individuals the choice of HIV testing using HIV self-testing or routine door-to-door HIV testing services. For individuals aged 18 years or older whose partner was absent during the household visit, an HIV self-test kit could be left for secondary distribution to the absent partner. The primary outcome was knowledge of HIV status (defined as self-reporting HIV positive to the community HIV care providers or accepting an offer of HIV testing services). Outcomes were measured among households that were first visited, and individuals first enumerated as a household member during the HIV self-testing intervention period. We analysed data at the individual level using population-average logistic regression models, accounting for clustering of outcomes by zone, to estimate the effect of the intervention. This trial is registered with ClinicalTrials.gov, number NCT02994329. FINDINGS: Between Feb 1, and April 30, 2017, the community HIV care providers enumerated 13 267 eligible individuals in the HIV self-testing group and 13 706 in the non-HIV self-testing group. After intervention implementation, 9027 (68%) of 13 267 in the HIV self-testing group had knowledge of HIV status compared with 8952 (65%) of 13 706 in the non-HIV self-testing group (adjusted odds ratio 1·30, 95% CI 1·03-1·65; p=0·03). The effect differed by sex (pinteraction=0·01). Among men, knowledge of HIV status was higher in the HIV self-testing group than in the non-HIV self-testing group (3843 [60%] of 6368 vs 3571 [55%] of 6486; adjusted odds ratio 1·31, 95% CI 1·07-1·60; p=0·01). There was no evidence of a between-group difference among female participants. INTERPRETATION: Providing a choice of HIV self-testing during delivery of door-to-door HIV testing services increased knowledge of HIV status, driven by an effect among men. Lay counsellors have a vital role to play in adapting HIV self-testing interventions to local context. FUNDING: The International Initiative for Impact Evaluation (3ie), the Bill & Melinda Gates Foundation, National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, and the President's Emergency Plan for AIDS Relief.

Mind the gap: Improving the performance of the reference laboratory to end-tuberculosis in Armenia.

INTRODUCTION: A one of the step towards achieving TB related targets is to ensure early and quality diagnosis of TB in national laboratories. WHO recommends that all national reference laboratories in TB burden countries strive to reach accreditation by 2025, based on ISO15189:2012 quality management system standard. To identify gaps, progress and evaluated the evolution in implementation QMS we performed a formal assessment of the national TB reference laboratory of Armenia, as well as estimates the specific quality indicators of NRL activity. METHODOLOGY: This is retrospective study cross-sectional study using laboratory data from the National TB Reference Laboratory in Armenia. Quality Management System assessments was conducted twice a year, using TB SLMTA assessment checklist. The sputum rejection and culture rates for quality indicators are calculated and assessed monthly. RESULTS: Compared to the baseline in 2016, there was a quality improvement reflecting the progress from zero to a "one star" in 2018. Areas that reached half of the target score included document and records, management review and responsibilities, evaluation and audits. Sections as "client management and customer service" and "evaluation and audits" stagnated in terms of progress. In terms of NRL performace, all indicators improved except for culture positivity in smear negative tuberculosis. CONCLUSION: Although a quality management system was introduced in the NRL there is now an urgent need to develop and implement an adapted roadmap for Armenia. This will be vital to hasten the much-needed pace towards accreditation.