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Psychiatric disorders and reoffending risk in individuals with community sentences in Sweden: a national cohort study.
BACKGROUND: Community sentences are widely used in many countries, often comprising the majority of criminal justice sanctions. Psychiatric disorders are highly prevalent in community-sentenced populations and are thus potential targets for treatment interventions designed to reduce reoffending. We examined the association between psychiatric disorders and reoffending in a national cohort of individuals given community sentences in Sweden, with use of a sibling control design to account for unmeasured familial confounding. METHODS: We did a longitudinal cohort study of 82 415 individuals given community sentences between Nov 1, 1991, and Dec 31, 2013, in Sweden using data from population-based registers. We calculated hazard ratios (HRs) for any reoffending and violent reoffending with Cox regression models. We compared community-sentenced siblings with and without psychiatric disorders to control for potential familial confounding. Additionally, we calculated population attributable fractions to assess the contribution of psychiatric disorders to reoffending behaviours. The primary outcomes of the study were any (general) reoffending and violent reoffending. FINDINGS: Between Nov 1, 1991, and Dec 31, 2013, those given community sentences who were diagnosed with any psychiatric disorder had an increased reoffending risk in men (adjusted HR 1·59, 95% CI 1·56-1·63 for any reoffending; 1·60, 1·54-1·66 for violent reoffending) and women (1·71, 1·61-1·82 for any reoffending; 2·19, 1·88-2·54 for violent reoffending). Risk estimates remained elevated after adjustment for familial confounding. Schizophrenia spectrum disorders, personality disorders, and substance use disorders had stronger associations with violent reoffending than did other psychiatric disorders. Assuming causality, the adjusted population attributable risk of psychiatric disorders on violent reoffending was 8·3% (95% CI 6·6-10·0) in the first 2 years of community follow-up in men and 30·9% (22·7-39·0) in women. INTERPRETATION: Psychiatric disorders were associated with an increased risk of any reoffending and violent reoffending in the community-sentenced population. The magnitude of the association between psychiatric disorders and reoffending varied by individual diagnosis. Substance use disorders had the highest absolute and relative risks. Most of the increased risk for any reoffending in individuals with psychiatric disorders could be attributed to comorbid substance misuse. Given their high prevalence, substance use disorders should be the focus of treatment programmes in community-sentenced populations. FUNDING: Wellcome Trust.
Given the current ageing population, by 2025, there will be over 1 million people with dementia in the UK. Large numbers of people provide informal care to people with dementia. The economic, social and psychological needs of carers of people with dementia can be huge. The networked society oﬀers theoretical beneﬁts to these carers, but also potential threats. In this chapter, these issues are examined with reference to previous studies of networked interventions to support carers of people with dementia. Information and communication technologies (ICTs) can support the expert carer to become informed, engage with others and organise socially and politically; the removal of traditional access barriers can reduce the isolation of carers through facilitating interaction with peers for social support, and with health, social and commercial organisations for the remote delivery of services; remote monitoring can allow caring at a distance and can provide visual and geographical monitoring as well as being linked to assistive devices and smart home technology. However, problems can be created through such issues as digital exclusion, digital abuse, depersonalisation and threats to privacy.
Travelling by public and personal transport is an important part of modern life. Travel phobia is a common and disabling problem characterized by strong fear and avoidance of travel. It can interfere severely with the individual’s occupational and social functioning. In clinical settings, fear of travel may present either as the main problem (i.e., as a specific phobia) or as part of another anxiety disorder (e.g., agoraphobia, claustrophobia). It may also develop as a response to experiencing a traumatic event when travelling (e.g., assault, terrorist attack, or severe accident). For example, it has been observed that driving phobias are common after road traffic accidents and can occur in the context of, or independently of, post-traumatic stress disorder (PTSD; Mayou, Bryant, and Ehlers, 2001).
In network meta-analysis (NMA), we synthesize all relevant evidence about health outcomes with competing treatments. The evidence may come from randomized clinical trials (RCT) or non-randomized studies (NRS) as individual participant data (IPD) or as aggregate data (AD). We present a suite of Bayesian NMA and network meta-regression (NMR) models allowing for cross-design and cross-format synthesis. The models integrate a three-level hierarchical model for synthesizing IPD and AD into four approaches. The four approaches account for differences in the design and risk of bias (RoB) in the RCT and NRS evidence. These four approaches variously ignoring differences in RoB, using NRS to construct penalized treatment effect priors and bias-adjustment models that control the contribution of information from high RoB studies in two different ways. We illustrate the methods in a network of three pharmacological interventions and placebo for patients with relapsing-remitting multiple sclerosis. The estimated relative treatment effects do not change much when we accounted for differences in design and RoB. Conducting network meta-regression showed that intervention efficacy decreases with increasing participant age. We also re-analysed a network of 431 RCT comparing 21 antidepressants, and we did not observe material changes in intervention efficacy when adjusting for studies' high RoB. We re-analysed both case studies accounting for different study RoB. In summary, the described suite of NMA/NMR models enables inclusion of all relevant evidence while incorporating information on the within-study bias in both observational and experimental data and enabling estimation of individualized treatment effects through the inclusion of participant characteristics. This article is protected by copyright. All rights reserved.
Stakeholder Perspectives of Clinical Artificial Intelligence Implementation: Systematic Review of Qualitative Evidence.
BACKGROUND: The rhetoric surrounding clinical artificial intelligence (AI) often exaggerates its effect on real-world care. Limited understanding of the factors that influence its implementation can perpetuate this. OBJECTIVE: In this qualitative systematic review, we aimed to identify key stakeholders, consolidate their perspectives on clinical AI implementation, and characterize the evidence gaps that future qualitative research should target. METHODS: Ovid-MEDLINE, EBSCO-CINAHL, ACM Digital Library, Science Citation Index-Web of Science, and Scopus were searched for primary qualitative studies on individuals' perspectives on any application of clinical AI worldwide (January 2014-April 2021). The definition of clinical AI includes both rule-based and machine learning-enabled or non-rule-based decision support tools. The language of the reports was not an exclusion criterion. Two independent reviewers performed title, abstract, and full-text screening with a third arbiter of disagreement. Two reviewers assigned the Joanna Briggs Institute 10-point checklist for qualitative research scores for each study. A single reviewer extracted free-text data relevant to clinical AI implementation, noting the stakeholders contributing to each excerpt. The best-fit framework synthesis used the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework. To validate the data and improve accessibility, coauthors representing each emergent stakeholder group codeveloped summaries of the factors most relevant to their respective groups. RESULTS: The initial search yielded 4437 deduplicated articles, with 111 (2.5%) eligible for inclusion (median Joanna Briggs Institute 10-point checklist for qualitative research score, 8/10). Five distinct stakeholder groups emerged from the data: health care professionals (HCPs), patients, carers and other members of the public, developers, health care managers and leaders, and regulators or policy makers, contributing 1204 (70%), 196 (11.4%), 133 (7.7%), 129 (7.5%), and 59 (3.4%) of 1721 eligible excerpts, respectively. All stakeholder groups independently identified a breadth of implementation factors, with each producing data that were mapped between 17 and 24 of the 27 adapted Nonadoption, Abandonment, Scale-up, Spread, and Sustainability subdomains. Most of the factors that stakeholders found influential in the implementation of rule-based clinical AI also applied to non-rule-based clinical AI, with the exception of intellectual property, regulation, and sociocultural attitudes. CONCLUSIONS: Clinical AI implementation is influenced by many interdependent factors, which are in turn influenced by at least 5 distinct stakeholder groups. This implies that effective research and practice of clinical AI implementation should consider multiple stakeholder perspectives. The current underrepresentation of perspectives from stakeholders other than HCPs in the literature may limit the anticipation and management of the factors that influence successful clinical AI implementation. Future research should not only widen the representation of tools and contexts in qualitative research but also specifically investigate the perspectives of all stakeholder HCPs and emerging aspects of non-rule-based clinical AI implementation. TRIAL REGISTRATION: PROSPERO (International Prospective Register of Systematic Reviews) CRD42021256005; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=256005. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/33145.
OBJECTIVES: This research aimed to fill a current knowledge gap, namely the current scope of clinical role of paramedics in primary care, in relation to specific constructs such a level of education and clinical experience. SETTING: The survey was distributed to paramedics in primary care across the UK through the College of Paramedics. PARTICIPANTS: A total of 341 surveys were returned (male=215). 90% of responses were from paramedics in England, 1.7% from paramedics in Northern Ireland, 4.6% from paramedics in Scotland and 2.9% from paramedics in Wales. This represents approximately 33% of the primary care paramedic workforce in England and Wales. Estimates for percentages in Northern Ireland and Scotland are unavailable due to the lack of workforce datasets capturing paramedics in primary care. RESULTS: Considerable variation was found in job titles, level of education and provision of clinical supervision of paramedics in primary care. Differing levels of practice were noted, despite guidance documents that attempt to standardise the role. Statistical analysis of quantitative data highlighted that relationships exist between paramedic clinical exposure in primary care, level of education, and ability of independently prescribe medicines and the extent to which clinical presentations are seen and examinations performed. However, free-text responses indicated that challenges in relation to access to further education and clinical supervision to support clinical development resulted in frustration for paramedics who work in this setting. CONCLUSIONS: As well as offering an insight into the demographics of the primary care paramedic work force, there is indication of the clinical scope of role undertaken in this setting. Based on our findings, we recommend changes to education and support, governance and legislation to ensure paramedics employed in primary care can work to achieve the full extent of their professional capability.
Evidence of lifestyle interventions in a pregnant population with chronic hypertension and/or pre-existing diabetes: A systematic review and narrative synthesis.
BACKGROUND: Pregnant people with chronic hypertension, pre-existing diabetes or both are at high risk of developing cardiovascular disease. Lifestyle interventions play an important role in disease management in non-pregnant populations. AIM: To review the existing evidence of randomised controlled trials (RCTs) that examine lifestyle interventions in pregnant people with chronic hypertension and/or pre-existing diabetes. METHODS: A systematic review and narrative synthesis was conducted. Five electronic databases were searched from inception to April 2021 for RCTs evaluating antenatal lifestyle interventions in people with chronic hypertension and/or pre-existing diabetes with outcomes to include weight or blood pressure change. RESULTS: Nine randomised controlled trials including 7438 pregnant women were eligible. Eight studies were mixed pregnant populations that included women with chronic hypertension and/or pre-existing diabetes. One study included only pregnant women with pre-existing diabetes. Intervention characteristics and procedures varied and targeted diet, physical activity and/or gestational weight. All studies reported weight and one study reported blood pressure change. Outcome data were frequently unavailable for the subset of women of interest, including subgroup data on important pregnancy and birth complications. Eligibility criteria were often ambiguous and baseline data on chronic hypertension was often omitted. CONCLUSION: A lack of primary interventional trials examining the effect of lifestyle interventions on weight and blood pressure outcomes in pregnant populations with chronic hypertension and/or pre-existing diabetes was evident. Lifestyle modification has the potential to alter disease progression. Future trials should address the ambiguity and frequent exclusion of these important populations.
Weight regain and mental health outcomes following behavioural weight management programmes: A systematic review with meta-analyses.
Behavioural weight management programmes (BWMPs) lead to weight loss but subsequent weight regain may harm mental health outcomes. We searched for randomised trials of BWMPs in adults with overweight/obesity with follow-up ≥12 months from baseline that measured weight change both at and after programme-end. We included only studies reporting mental health at or after programme-end. We meta-analysed changes in various mental health outcomes using a random-effects model by nature of the comparator group and by time since programme end. Subgroup analysis explored heterogeneity. We used mixed models and meta-regression to analyse the association between change in weight and change in depression and/or anxiety over time, with higher scores indicating greater depression and/or anxiety. We included 47 studies. When comparing BWMPs (diet and/or exercise) to control, most estimates included the possibility of no difference, but pooled estimates for psychological wellbeing, self-esteem and mental-health composite scores at programme-end, anxiety at 1-6 months, and depression at 7-12 months after programme-end suggested improvements in intervention arms relative to control, with 95% CIs excluding no difference. Pooled estimates found no evidence that BWMPs harmed mental health at programme end or beyond. Mental health composite scores at programme-end favoured diet and exercise interventions over diet alone, with 95% CIs excluding no difference. All other measures and timepoints included the possibility of no difference or could not be meta-analysed due to high heterogeneity or a paucity of data. Mixed models and meta-regression of the association between change in depression and/or anxiety scores over time, and change in weight, were inconclusive. Despite weight regain after BWMPs, our meta-analyses found no evidence of mental health harm and some evidence that BWMPs may improve some dimensions of mental health at and after programme-end.
Preexisting Neuropsychiatric Conditions and Associated Risk of Severe COVID-19 Infection and Other Acute Respiratory Infections.
Importance: Evidence indicates that preexisting neuropsychiatric conditions confer increased risks of severe outcomes from COVID-19 infection. It is unclear how this increased risk compares with risks associated with other severe acute respiratory infections (SARIs). Objective: To determine whether preexisting diagnosis of and/or treatment for a neuropsychiatric condition is associated with severe outcomes from COVID-19 infection and other SARIs and whether any observed association is similar between the 2 outcomes. Design, Setting, and Participants: Prepandemic (2015-2020) and contemporary (2020-2021) longitudinal cohorts were derived from the QResearch database of English primary care records. Adjusted hazard ratios (HRs) with 99% CIs were estimated in April 2022 using flexible parametric survival models clustered by primary care clinic. This study included a population-based sample, including all adults in the database who had been registered with a primary care clinic for at least 1 year. Analysis of routinely collected primary care electronic medical records was performed. Exposures: Diagnosis of and/or medication for anxiety, mood, or psychotic disorders and diagnosis of dementia, depression, schizophrenia, or bipolar disorder. Main Outcomes and Measures: COVID-19-related mortality, or hospital or intensive care unit admission; SARI-related mortality, or hospital or intensive care unit admission. Results: The prepandemic cohort comprised 11 134 789 adults (223 569 SARI cases [2.0%]) with a median (IQR) age of 42 (29-58) years, of which 5 644 525 (50.7%) were female. The contemporary cohort comprised 8 388 956 adults (58 203 severe COVID-19 cases [0.7%]) with a median (IQR) age of 48 (34-63) years, of which 4 207 192 were male (50.2%). Diagnosis and/or treatment for neuropsychiatric conditions other than dementia was associated with an increased likelihood of a severe outcome from SARI (anxiety diagnosis: HR, 1.16; 99% CI, 1.13-1.18; psychotic disorder diagnosis and treatment: HR, 2.56; 99% CI, 2.40-2.72) and COVID-19 (anxiety diagnosis: HR, 1.16; 99% CI, 1.12-1.20; psychotic disorder treatment: HR, 2.37; 99% CI, 2.20-2.55). The effect estimate for severe outcome with dementia was higher for those with COVID-19 than SARI (HR, 2.85; 99% CI, 2.71-3.00 vs HR, 2.13; 99% CI, 2.07-2.19). Conclusions and Relevance: In this longitudinal cohort study, UK patients with preexisting neuropsychiatric conditions and treatments were associated with similarly increased risks of severe outcome from COVID-19 infection and SARIs, except for dementia.
The Use of Multi-Criteria Decision Analysis (MCDA) to Support Decision-Making in Healthcare: an Updated Systematic Literature Review.
<h4>Background</h4>Multi-Criteria Decision Analysis (MCDA) is increasingly used for decision-making in healthcare. However, its application in different decision-making contexts is still unclear.<h4>Objectives</h4>To provide a comprehensive review of MCDA studies performed in healthcare and to summarise its application in different decision contexts.<h4>Methods</h4>We updated a systematic review conducted in 2013 by searching EMBASE, Medline and Google Scholar for MCDA-based evaluations in healthcare, published in English between August 2013 and November 2020. We also expanded the search by reviewing grey literature found via Trip Medical Database and Google, published between January 1990 and November 2020. A comprehensive template was developed to extract information about the decision context, criteria, methods, stakeholders involved, and the sensitivity analyses conducted.<h4>Results</h4>From the 4,295 identified studies, 473 studies were eligible for full-text review after assessing titles and abstracts. Of those, 228 studies met inclusion criteria and underwent data extraction. The use of MCDA continues to grow in healthcare literature, with most (49%) of the studies informing priority-setting decisions. Safety, cost and quality of care delivery are the most frequently used criteria, although there are considerable differences across decision contexts. Almost half of the MCDA studies used the linear-additive model while, scales and the analytic hierarchy process were the most used techniques for scoring and weighting, respectively. Considerable flaws in the application and reporting of the methods were found.<h4>Conclusions</h4>A guide on how to conduct and report MCDA that acknowledges the particularities of the different decision contexts and methods needs to be developed.
Background: The emergence of Integrated Care Systems (ICSs) across England poses an additional challenge and responsibility for local commissioners to accelerate the implementation of integrated care programmes and improve the overall efficiency across the system. To do this, ICS healthcare commissioners could learn from the experience of the former local commissioning structures and identify areas of improvement in the commissioning process. This study describes the investment decision process in integrated care amid the transition toward ICSs, highlights challenges, and provides recommendations to inform ICSs in their healthcare commissioning role. Methods: Twenty-six semi-structured interviews were conducted with local commissioners and other relevant stakeholders in South East England in 2021. Interviews were supplemented with literature. Results: England's local healthcare commissioning has made the transition towards a new organisational architecture, with some integrated care programmes running, and a dual top-down and bottom-up prioritisation process in place. The commissioning and consequent development of integrated care programmes have been hindered by various barriers, including difficulties in accessing and using information, operational challenges, and resource constraints. Investment decisions have mainly been driven by national directives and budget considerations, with a mixture of subjective and objective approaches. A systematic and data-driven framework could replace this ad-hoc prioritisation of integrated care and contribute to a more rational and transparent commissioning process. Conclusion: The emerging ICSs seem to open an opportunity for local commissioners to strengthen the commissioning process of integrated care with evidence-based priority-setting approaches similar to the well-established health technology assessment framework at the national level.
BackgroundSince 1993, Colombia has had a mandatory social health insurance scheme that aims to provide universal health coverage to all citizens. However, some contributory regime participants purchase voluntary private health insurance (VPHI) to access better quality health services (i. e., physicians and hospitals), shorter waiting times, and a more extensive providers' network. This article aims to estimate the price elasticity of demand for the VPHI market in Colombia.MethodsWe use data from the 2016-2017 consumer expenditure national survey and apply a Heckman selection model to address the selection problem into purchasing private insurance. Using the estimation results to further estimate the price semi-elasticity for VPHI, we then calculate the price elasticity for the households' health expenditure and acquisition of VHPI.ResultsOur main findings indicate that a 1% VPHI price increase reduces the proportion of households affiliated to a VPHI in the country by about 2.32% to 4.66%, with robust results across sample restrictions. There are relevant differences across age groups, with younger households' heads being less responsive to VPHI price changes.ConclusionsWe conclude that the VPHI demand in Colombia is noticeably elastic, and therefore tax policy changes can have a significant impact on public health insurance expenditures. The government should estimate the optimal VPHI purchase in order to reduce any welfare loss that the current arrangement might be generating.
BackgroundThe negative association between income inequality and health has been known in the literature as the Income Inequality Hypothesis (IIH). Despite the multiple studies examining the validity of this hypothesis, evidence is still inconclusive, and the debate remains unsolved. In addition, relatively few studies have focused their attention on developing or emerging economies, where levels of inequality tend to be the highest in the world. This work examines the statistical association between income inequality and self-rated health status in Colombia, a highly unequal Latin American country.MethodsTo explore whether this association is present in the general population or whether it is only confined to the bottom of the income distribution, we use data from the 2011-2019 National Quality of Life Survey. Multiple probit estimations are considered for testing the robustness of the IIH.ResultsEvidence favouring the IIH was found, even after controlling for individual income levels, average regional income, and socioeconomic characteristics. The link between income inequality and the probability of reporting poor health seems to be present across all income quintiles. However, the magnitude of such association is considerably smaller when using inequality measures with relatively greater sensitivity to income differences among the rich.ConclusionsThe association between regional income inequality and individual's self-rated health status in Colombia is not only confined to low-income individuals but extends across all socioeconomic strata. This association is robust to the income inequality measure implemented, the income-unit of analysis, and changes in the sample. It is suggested that reducing income disparities can potentially contribute to improving individual's health.
Implementing self-management: a mixed-methods study of women’s experiences of a postpartum hypertension intervention (SNAP-HT)
Abstract Background Self-management strategies are effective in a number of medical conditions; however, implementation studies have demonstrated adoption into clinical practice can be problematic. The process of implementation was explored during a pilot randomised controlled trial evaluating postpartum blood pressure self-management, in women with medicated hypertensive disorders of pregnancy. Methods A mixed methods study using semi-structured interviews with a qualitative and a scored (quantitative) component were undertaken as part of a pilot randomised controlled trial (SNAP-HT) in postnatal women with medicated gestational hypertension or pre-eclampsia. Women were randomised to usual care or blood pressure self-management. Self-management entailed daily home blood pressure monitoring and automated medication reduction via telemonitoring. Women from both groups optionally consented to participate in audio-recorded interviews, at four weeks and six months postpartum. Interview questions were developed to explore the proposed benefits of self-management and the constructs of Normalisation Process Theory. Participants provided a score (Likert scale 1-5) for each question and were encouraged to expand upon these answers through further discussion. The interviews were transcribed and analysed using the framework approach. Results Sixty-eight women, 34 from each randomised group, completed at least one audio-recorded interview. Several overarching themes emerged from analysis of 126 interview transcripts: control; convenience; confidence, communication and knowledge; concern; constraints; and components of the intervention. In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both four weeks and six months: adjusted differences 0.6 (95% confidence interval (CI) 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively. Conclusions Interviews and quantitative data showed that self-management enhanced women’s sense of control, and improved their blood pressure-related anxiety. Prior to taking part, a few women anticipated that home monitoring might increase anxiety, but stated that it had the opposite effect. Self-management was perceived as more flexible, reactive and as enabling more targeted down-titration of medication. These data provide considerable support for blood pressure self-management postpartum, and reinforce the effectiveness of the intervention used in this study. Trial registration Prospectively registered with ClinicalTrials.gov on 07/01/2015 (NCT02333240) https://clinicaltrials.gov/ct2/show/NCT02333240.
Multicenter Diagnostic Evaluation of a Novel Coronavirus Antigen Lateral Flow Test among Symptomatic Individuals in Brazil and the United Kingdom.
The COVID-19 pandemic has led to the commercialization of many antigen-based rapid diagnostic tests (Ag-RDTs), requiring independent evaluations. This report describes the clinical evaluation of the Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Beijing Hotgen Biotech Co., Ltd.), at two sites within Brazil and one in the United Kingdom. The collected samples (446 nasal swabs from Brazil and 246 nasopharyngeal samples from the UK) were analyzed by the Ag-RDT and compared to reverse transcription-quantitative PCR (RT-qPCR). Analytical evaluation of the Ag-RDT was performed using direct culture supernatants of SARS-CoV-2 strains from the wild-type (B.1), Alpha (B.1.1.7), Delta (B.1.617.2), Gamma (P.1), and Omicron (B.1.1.529) lineages. An overall sensitivity and specificity of 88.2% (95% confidence interval [CI], 81.3 to 93.3) and 100.0% (95% CI, 99.1 to 100.0), respectively, were obtained for the Brazilian and UK cohorts. The analytical limit of detection was determined as 1.0 × 103 PFU/mL (Alpha), 2.5 × 102 PFU/mL (Delta), 2.5 × 103 PFU/mL (Gamma), and 1.0 × 103 PFU/mL (Omicron), giving a viral copy equivalent of approximately 2.1 × 104 copies/mL, 9.0 × 105 copies/mL, 1.7 × 106 copies/mL, and 1.8 × 105 copies/mL for the Ag-RDT, respectively. Overall, while a higher sensitivity was claimed by the manufacturers than that found in this study, this evaluation finds that the Ag-RDT meets the WHO minimum performance requirements for sensitivity and specificity of COVID-19 Ag-RDTs. This study illustrates the comparative performance of the Hotgen Ag-RDT across two global settings and considers the different approaches in evaluation methods. IMPORTANCE Since the beginning of the SARS-CoV-2 pandemic, we have witnessed growing numbers of antigen rapid diagnostic tests (Ag-RDTs) being brought to market. In the United Kingdom, this was somewhat controlled indirectly as the government offered free tests from a small number of companies. However, as this has now ceased, individuals are responsible for their own acquisition of test kits. Similarly in Brazil, as of January 2022, pharmacies and other health care retailers are permitted to sell Ag-RDTs directly to the community. Many of these Ag-RDTs have not been externally evaluated, and results are not readily available to the public. Thus, there is now a need for a transparent evaluation of Ag-RDTs with both analytical and clinical evaluation. We present an independent review of the Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Beijing Hotgen Biotech Co., Ltd.), at two sites within Brazil and one in the United Kingdom.