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AbstractObjectiveTo determine whether the addition of placental growth factor (PlGF) measurement to current clinical assessment of women with suspected pre-eclampsia before 37 weeks' gestation would reduce maternal morbidity without increasing neonatal morbidity.DesignStepped wedge cluster randomised control trial from 29 June 2017 to 26 April 2019.SettingNational multisite trial in seven maternity hospitals throughout the island of IrelandParticipantsWomen with a singleton pregnancy between 20+0 to 36+6 weeks’ gestation, with signs or symptoms suggestive of evolving pre-eclampsia. Of the 5718 women screened, 2583 were eligible and 2313 elected to participate.InterventionParticipants were assigned randomly to either usual care or to usual care plus the addition of point-of-care PlGF testing based on the randomisation status of their maternity hospital at the time point of enrolment.Main outcomes measuresCo-primary outcomes of composite maternal morbidity and composite neonatal morbidity. Analysis was on an individual participant level using mixed-effects Poisson regression adjusted for time effects (with robust standard errors) by intention-to-treat.ResultsOf the 4000 anticipated recruitment target, 2313 eligible participants (57%) were enrolled, of whom 2219 (96%) were included in the primary analysis. Of these, 1202 (54%) participants were assigned to the usual care group, and 1017 (46%) were assigned the intervention of additional point-of-care PlGF testing. The results demonstrate that the integration of point-of-care PlGF testing resulted in no evidence of a difference in maternal morbidity—457/1202 (38%) of women in the control group versus 330/1017 (32%) of women in the intervention group (adjusted risk ratio (RR) 1.01 (95% CI 0.76 to 1.36), P=0.92)—or in neonatal morbidity—527/1202 (43%) of neonates in the control group versus 484/1017 (47%) in the intervention group (adjusted RR 1.03 (0.89 to 1.21), P=0.67).ConclusionsThis was a pragmatic evaluation of an interventional diagnostic test, conducted nationally across multiple sites. These results do not support the incorporation of PlGF testing into routine clinical investigations for women presenting with suspected preterm pre-eclampsia, but nor do they exclude its potential benefit.Trial registrationClinicalTrials.gov NCT02881073.

Multiplexed point-of-care testing (xPOCT), which is simultaneous on-site detection of different analytes from a single specimen, has recently gained increasing importance for clinical diagnostics, with emerging applications in resource-limited settings (such as in the developing world, in doctors’ offices, or directly at home). Nevertheless, only single-analyte approaches are typically considered as the major paradigm in many reviews of point-of-care testing. Here, we comprehensively review the present diagnostic systems and techniques for xPOCT applications. Different multiplexing technologies (e.g., bead- or array-based systems) are considered along with their detection methods (e.g., electrochemical or optical). We also address the unmet needs and challenges of xPOCT. Finally, we critically summarize the in-field applicability and the future perspectives of the presented approaches. Simultaneous on-site measurement of different substances from a single sample, called multiplexed point-of-care testing, has recently become more and more important for in vitro diagnostics. The major aim for the development of xPOCT systems is the smart combination of a high-performing device with a low system complexity. Thus, the on-site tests are realized in a short time by non-experts and ensure comparable results with clinical and central laboratory findings. A multiplexing capability of up to 10 analytes has been sufficient for many recent xPOCT applications. The future of xPOCT devices will be driven by novel biotechnologies (e.g., aptamers) or targets (e.g., circulating RNAs or tumor cells, exosomes, and miRNAs), as well as applications like personalized medicine, homecare monitoring, and wearables.

Background Point-of-care testing (PoCT) is an increasingly important diagnostic tool in the healthcare system for accessible pathology testing in hospital, primary care, and community care settings. Clear regulation and governance models are important to ensure quality of PoCT results for patient care. Methods This review aimed to identify existing regulation and guidelines for management of PoCT and how this has been implemented within Australian healthcare services. We conducted a search of academic publications in PubMed and grey literature (national, state, and independent organisations) and other publicly available information from internet searches for governance of PoCT in Australia. Relevant data from these sources were extracted and narratively synthesised. Results Forty-seven sources (17 studies from PubMed, 30 grey literature) were included in the final review. Of the grey literature sources, fifteen current PoCT governance documents comprising of six standards, five guidelines and four frameworks at the international, national and jurisdictional level were included with an increasing number of grey literature sources since the onset of the COVID-19 pandemic in 2020. The seventeen included research articles were categorised according to implementation barriers and facilitators with the themes of workforce, clinical governance, PoCT workflow, and cost. An understanding of the clinical and cultural context for PoCT was the most frequently reported facilitator of PoCT, while the most frequently reported barrier was related to inadequate data management. Conclusion This review demonstrated limited and inconsistent sources on regulatory and governance models for implementing and managing PoCT in Australia. Identified PoCT programs showcased diverse implementation and governance models to support quality PoCT, with few reporting formal accreditation. Streamlined, practical regulation and governance for PoCT may increase adoption across healthcare settings while ensuring quality results and meeting the needs of patients and healthcare practitioners.

High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART) initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit. RapIT (Rapid Initiation of Treatment) was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa, a primary health clinic (PHC) and a hospital-based HIV clinic. Adult (≥18 y old), non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Patients in the rapid-initiation arm of the study (\"rapid arm\") received a point-of-care (POC) CD4 count if needed; those who were ART-eligible received a POC tuberculosis (TB) test if symptomatic, POC blood tests, physical exam, education, counseling, and antiretroviral (ARV) dispensing. Patients in the standard-initiation arm of the study (\"standard arm\") followed standard clinic procedures (three to five additional clinic visits over 2-4 wk prior to ARV dispensing). Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (≤400 copies/ml) within 10 mo of study enrollment. Secondary outcomes included initiation of ART ≤90 d of study enrollment, retention in care, time to ART initiation, patient-level predictors of primary outcomes, prevalence of TB symptoms, and the feasibility and acceptability of the intervention. A survival analysis was conducted comparing attrition from care after ART initiation between the groups among those who initiated within 90 d. Three hundred and seventy-seven patients were enrolled in the study between May 8, 2013 and August 29, 2014 (median CD4 count 210 cells/mm3). In the rapid arm, 119/187 patients (64%) initiated treatment and were virally suppressed at 10 mo, compared to 96/190 (51%) in the standard arm (relative risk [RR] 1.26 [1.05-1.50]). In the rapid arm 182/187 (97%) initiated ART ≤90 d, compared to 136/190 (72%) in the standard arm (RR 1.36, 95% confidence interval [CI], 1.24-1.49). Among 318 patients who did initiate ART within 90 d, the hazard of attrition within the first 10 mo did not differ between the treatment arms (hazard ratio [HR] 1.06; 95% CI 0.61-1.84). The study was limited by the small number of sites and small sample size, and the generalizability of the results to other settings and to non-research conditions is uncertain. Offering single-visit ART initiation to adult patients in South Africa increased uptake of ART by 36% and viral suppression by 26%. This intervention should be considered for adoption in the public sector in Africa. ClinicalTrials.gov NCT01710397, and South African National Clinical Trials Register DOH-27-0213-4177.

Infectious virus outbreaks pose a significant challenge to public healthcare systems. Early and accurate virus diagnosis is critical to prevent the spread of the virus, especially when no specific vaccine or effective medicine is available. In clinics, the most commonly used viral detection methods are molecular techniques that involve the measurement of nucleic acids or proteins biomarkers. However, most clinic‐based methods require complex infrastructure and expensive equipment, which are not suitable for low‐resource settings. Over the past years, smartphone‐based point‐of‐care testing (POCT) has rapidly emerged as a potential alternative to laboratory‐based clinical diagnosis. This review summarizes the latest development of virus detection. First, laboratory‐based and POCT‐based viral diagnostic techniques are compared, both of which rely on immunosensing and nucleic acid detection. Then, various smartphone‐based POCT diagnostic techniques, including optical biosensors, electrochemical biosensors, and other types of biosensors are discussed. Moreover, this review covers the development of smartphone‐based POCT diagnostics for various viruses including COVID‐19, Ebola, influenza, Zika, HIV, et al. Finally, the prospects and challenges of smartphone‐based POCT diagnostics are discussed. It is believed that this review will aid researchers better understand the current challenges and prospects for achieving the ultimate goal of containing disease‐causing viruses worldwide. This review summarizes the latest development of virus detection techniques, with the special focus on smartphone‐based viral diagnostics whose advances have enabled laboratory‐based molecular detections to be performed with plug‐and‐play stand‐alone devices. Discussion on challenges and future perspectives of smartphone‐based viral diagnostics is highlighted, which might push the development of mobile diagnostics forward with scientific and available guidance.

ObjectivesMany patients presenting with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in primary care do not benefit from antibiotics. Excessive use wastes resources, promotes antimicrobial resistance and can harm patients.DesignWe conducted a within-trial economic evaluation, using a UK National Health Service perspective, as part of the multicentre, parallel-arm, open, individually randomised, controlled PACE trial.SettingParticipating general practices in primary care.ParticipantsPACE included 324 and 325 consenting participants presenting with AECOPD in the usual-care and CRP-guided groups, respectively.InterventionWe assessed the cost-effectiveness (CE) of a C-reactive protein point-of-care-test (CRP-POCT) in addition to usual clinical assessment to guide antibiotic prescribing for AECOPD in primary care.Primary and secondary outcome measuresA cost-effectiveness analysis (CEA) of incremental cost per 1% antibiotic consumption reduction at 4 weeks and a cost-utility analysis (CUA) at 6 months were performed, based on a modified intention-to-treat population. Sensitivity analyses assessed the impact of uncertainty on the results. CE acceptability curves represent the probability of CRP-POCT being cost-effective at different willingness-to-pay (WTP) thresholds.ResultsBoth groups had similar clinical outcomes, but a 20% absolute reduction in antibiotic consumption was observed in the CRP-guided group. CRP-POCT costs of £11.31 per test were largely offset by savings in healthcare resource use related to COPD. The mean incremental CE ratios of CRP-POCT were £120 per 1% absolute reduction in antibiotic consumption at 4 weeks and £1054 per quality-adjusted life-year (QALY) gained at 6 months. Sensitivity analysis showed that the CEA results were most affected by changes in healthcare costs, while CUA was sensitive due to marginal differences in costs and outcomes. There is a 73% probability of CRP-POCT being cost-effective at WTP ≤£20 000 per QALY gained.ConclusionCRP-POCT is a cost-effective intervention for safely reducing antibiotic consumption in patients with AECOPD.Trial registration number ISRCTN24346473

Sexually transmitted infections (STIs) are among the most common communicable diseases globally and are associated with significant morbidity and mortality worldwide. Point-of-care tests have the potential to revolutionize the prevention and control of STIs by enabling rapid diagnosis and early treatment of infections, thus interrupting transmission and preventing the sequelae of untreated infections. Currently, there are several point-of-care (POC) tests available for the diagnosis of Treponema pallidum, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections, although these tests differ with regard to their performance, turnaround time, and cost. To provide an updated review of the POC tests available and under development for the diagnosis of T pallidum, C trachomatis, N gonorrhoeae, and T vaginalis infections, to discuss the context for which these tests might be used, and to highlight future directions for test development. We reviewed the literature pertaining to the recent development and performance evaluations of POC tests for the diagnosis of syphilis, chlamydia, gonorrhea, and trichomonas. Recently, there has been rapid development of new POC tests for STIs. Although there are inexpensive, rapid, and accurate POC tests available for syphilis, there are few such tests available for the diagnosis of chlamydia, gonorrhea, or trichomonas, and currently none with the ability to detect antimicrobial resistance in N gonorrhoeae. Research evaluating implementation strategies for the currently available tests and the development of additional POC tests that are rapid, accurate, and affordable are urgently needed to address the rising number of STIs worldwide.

Background Antibiotic resistance is threatening to make gonorrhoea untreatable. Point-of-care (POC) tests that detect resistance promise individually tailored treatment, but might lead to more treatment and higher levels of resistance. We investigate the impact of POC tests on antibiotic-resistant gonorrhoea. Methods We used data about the prevalence and incidence of gonorrhoea in men who have sex with men (MSM) and heterosexual men and women (HMW) to calibrate a mathematical gonorrhoea transmission model. With this model, we simulated four clinical pathways for the diagnosis and treatment of gonorrhoea: POC test with (POC+R) and without (POC−R) resistance detection, culture and nucleic acid amplification tests (NAATs). We calculated the proportion of resistant infections and cases averted after 5 years, and compared how fast resistant infections spread in the populations. Results The proportion of resistant infections after 30 years is lowest for POC+R (median MSM: 0.18 % , HMW: 0.12 % ), and increases for culture (MSM: 1.19 % , HMW: 0.13 % ), NAAT (MSM: 100%, HMW: 99.27 % ), and POC−R (MSM: 100%, HMW: 99.73 % ). Per 100 000 persons, NAAT leads to 36 366 (median MSM) and 1228 (median HMW) observed cases after 5 years. Compared with NAAT, POC+R averts more cases after 5 years (median MSM: 3353, HMW: 118). POC tests that detect resistance with intermediate sensitivity slow down resistance spread more than NAAT. POC tests with very high sensitivity for the detection of resistance are needed to slow down resistance spread more than by using culture. Conclusions POC with high sensitivity to detect antibiotic resistance can keep gonorrhoea treatable longer than culture or NAAT. POC tests without reliable resistance detection should not be introduced because they can accelerate the spread of antibiotic-resistant gonorrhoea.

Master high-yield point-of-care ultrasound applications that are targeted specifically to answer questions that arise commonly in the outpatient clinic!Written for primary care providers in Family Medicine, Pediatrics and Internal Medicine, Ultrasound for Primary Care is a practical, easy-to-read guide.

Viscoelastic point-of-care (POC) tests are commonly used to provide prompt diagnosis of coagulopathy and allow targeted treatments in bleeding patients on ECMO. We evaluated the clinical effectiveness of point-of-care (POC) testing for anticoagulation management in patients on extracorporeal membrane oxygenation (ECMO). Systematic review and meta-analysis. Eligible studies evaluating the use of thromboelastography- or thromboelastometry-guided algorithms, anti-factor Xa and platelet function testing were selected after screening the literature from July 1975 to January 2020. Patients on ECMO support. Anticoagulation management on ECMO patients. Rotational thromboelastometry, thromboelastography, alone or combined with platelet function testing. Trials monitoring the anticoagulation effects during ECMO using an anti-factor Xa assay were included in the systematic review. The primary outcomes were bleeding events, surgical revisions, thrombosis events and ECMO circuit change/failure. Secondary outcomes were blood-product transfusions, cerebrovascular accidents, mortality on ECMO, ECMO duration, intensive care unit and hospital discharge rates, and in-hospital mortality. Thirty-one trials enrolling 1684 participants were included in the systematic review. Four trials enrolling 547 subjects were included in the meta-analysis. The use of a POC testing device resulted in improved detection of surgical bleeding (RR: 0.68, 95% CI 0.49 to 0.94, I2 = 0%; χ2 test for heterogeneity, P = 0.02). The use of POC-guided algorithms did not affect bleeding (RR:0.78, 95% CI 0.58 to 1.04, I2 = 47%; χ2 test for heterogeneity, P = 0.09), thrombosis events (RR:1.35, 95% CI 0.86 to 2.12, I2 = 37%; χ2 test for heterogeneity, P = 0.19), or ECMO circuit/change (RR:0.90, 95% CI 0.48 to 1.71, I2 = 28%; χ2 test for heterogeneity, P = 0.75). Routine use of POC tests did not improve the main clinical outcomes beyond suggesting a diagnosis of surgical bleeding in ECMO patients. •This meta-analysis evaluates POC tests for anticoagulation in ECMO.•POC-guided algorithms did not affect bleeding, thrombosis, and ECMO circuit/change.•Use of POC-guided algorithms resulted in a reduction in surgical revision.