Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South Africa.

BACKGROUND: In 2018, the World Health Organization commenced a multi-country validation study of the Cepheid GeneXpert for a range of molecular-based point-of-care (POC) tests in primary care settings. One study arm focused on the evaluation of POC tests for screening 'women at risk' for chlamydia (CT), gonorrhoea (NG) and trichomonas (TV) in four countries - Australia, Guatemala, Morocco and South Africa. METHODS: Study participants completed a pre-test questionnaire which included demographics, clinical information and general questions on POC testing (POCT). Two vaginal swab samples (either self-collected or clinician collected) from each patient were tested on the GeneXpert at the POC and at a reference laboratory using quality-assured nucleic acid amplification tests (NAATs). RESULTS: One thousand three hundred and eighty-three women were enrolled: 58.6% from South Africa, 29.2% from Morocco, 6.2% from Guatemala, and 6.0% from Australia. 1296 samples for CT/NG and 1380 samples for TV were tested by the GeneXpert and the reference NAAT. The rate of unsuccessful tests on the GeneXpert was 1.9% for CT, 1.5% for NG and 0.96% for TV. The prevalence of CT, NG and TV was 31%, 13% and 23%, respectively. 1.5% of samples were positive for all three infections; 7.8% were positive for CT and NG; 2.4% were positive for NG and TV; and 7.3% were positive for CT and TV. Compared to reference NAATs, pooled estimates of sensitivity for the GeneXpert tests were 83.7% (95% confidence intervals 69.2-92.1) for CT, 90.5% (85.1-94.1) for NG and 64.7% (58.1-70.7) for TV (although estimates varied considerably between countries). Estimates for specificity were ≥96% for all three tests both within- and between-countries. Pooled positive and negative likelihood ratios were: 32.7 ([CI] 21.2-50.5) and 0.17 (0.08-0.33) for CT; 95.3 (36.9-245.7) and 0.10 (0.06-0.15) for NG; and 56.5 (31.6-101.1) and 0.35 (0.27-0.47) for TV. CONCLUSION: This multi-country evaluation is the first of its kind world-wide. Positive likelihood ratios, as well as specificity estimates, indicate the GeneXpert POC test results for CT, NG and TV were clinically acceptable for ruling in the presence of disease. However, negative likelihood ratios and variable sensitivity estimates from this study were poorer than expected for ruling out these infections, particularly for TV. TRIAL REGISTRATION: Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee, as well as local ethics committees from all participating countries.

Quality control and external quality assessment for the independent clinic-based evaluation of point-of-care testing to detect Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in eight countries.

BACKGROUND: Sexually transmitted infections caused by Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) remain significant global health problems. The World Health Organization (WHO) has recently conducted a multi-faceted, multi-country validation study (ProSPeRo), which included an evaluation of the Xpert CT/NG and Xpert TV assays on the GeneXpert system (Cepheid, Sunnyvale, Ca., USA) in clinic-based settings across eight countries. To support the study, a training and quality management system was implemented and evaluated. METHODS: A comprehensive training program for the study was developed. Quality control (QC) and external quality assessment (EQA) samples were provided by an accredited quality assurance provider. QC testing was conducted at 14 point-of-care testing (POCT) clinics, while EQA samples were tested by the POCT sites and a reference laboratory supporting each clinic. RESULTS: For QC testing, concordance with the expected results for CT and NG was > 99% and rates of unsuccessful tests were < 4%. For TV testing, concordance was similar (97%), but rates of unsuccessful tests were high (18%), particularly in the 'TV negative' sample. For EQA testing initially conducted in 2018, concordance was 100% for CT and NG, and 90% for TV for the reference laboratory group (which used non-GeneXpert systems). Concordance for the POCT group was also high (> 94%) for all analytes, but this cohort (which used GeneXpert systems) exhibited a high rate of unsuccessful TV tests. All but one of these unsuccessful tests was subcategorised as 'invalid'. CONCLUSIONS: The high level of concordance for QC and EQA testing confirm that the trained operators at the POC clinical sites were competent to conduct POC testing and that the training and quality systems implemented for the ProSPeRo study were effective. The quality materials used were satisfactory for CT and NG but exhibited poor performance for TV testing on the GeneXpert system. The WHO should continue to work with industry and EQA providers to provide improved materials that are reliable, stable and cost effective for quality management, as it seeks to rollout molecular-based STI POCT in non-laboratory-based settings. TRIAL REGISTRATION: Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee.

We have reached single-visit testing, diagnosis, and treatment for hepatitis C infection, now what?

INTRODUCTION: Progress toward hepatitis C virus (HCV) elimination is impeded by low testing and treatment due to the current diagnostic pathway requiring multiple visits leading to loss to follow-up. Point-of-care testing technologies capable of detecting current HCV infection in one hour are a 'game-changer.' These tests enable diagnosis and treatment in a single visit, overcoming the barrier of multiple visits that frequently leads to loss to follow-up. Combining point-of-care HCV antibody and RNA tests should improve cost-effectiveness, patient/provider acceptability, and testing efficiency. However, implementing HCV point-of-care testing programs at scale requires multiple considerations. AREAS COVERED: This commentary explores the need for point-of-care HCV tests, diagnostic strategies to improve HCV testing, key considerations for implementing point-of-care HCV testing programs, and remaining challenges for point-of-care testing (including operator training, quality management, connectivity and reporting systems, regulatory approval processes, and the need for more efficient tests). EXPERT OPINION: It is exciting that single-visit testing, diagnosis, and treatment for HCV infection have been achieved. Innovations afforded through COVID-19 should facilitate the accelerated development of low-cost, rapid, and accurate tests to improve HCV testing. The next challenge will be to address barriers and facilitators for implementing point-of-care testing to deliver them at scale.

Flexible and Innovative Connectivity Solution to Support National Decentralized Infectious Diseases Point-of-Care Testing Programs in Primary Health Services: Descriptive Evaluation Study.

BACKGROUND: Molecular point-of-care (POC) testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) has been available in regional and remote primary health services in Australia as part of a decentralized POC testing program since 2016 and for SARS-CoV-2 from 2020. As there was no suitable existing connectivity infrastructure to capture and deliver POC test results to a range of end users, a new system needed to be established. OBJECTIVE: The aim of the study is to design, implement, and optimize a connectivity system to meet clinical management, analytical quality management, and public health surveillance needs. METHODS: We used commercially available e-messaging technology coupled with adapted proprietary software to integrate a decentralized molecular POC testing platform (GeneXpert) in primary health services and interface with end-user databases. This connectivity infrastructure was designed to overcome key barriers to the implementation, integration, and monitoring of these large multijurisdictional infectious disease POC testing networks. Test result messages were tailored to meet end-user needs. Using centrally captured deidentified data, we evaluated the time to receipt of test results and completeness of accompanying demographic data. RESULTS: From January 2016 to April 2020, we operationalized the system at 31 health services across 4 jurisdictions and integrated with 5 different patient management systems to support the real-time delivery of 29,356 CT/NG and TV test results to designated recipients (patient management system and local clinical and central program databases). In 2019, 12,105 CT/NG and TV results were delivered, and the median time to receipt of results was 3.2 (IQR 2.2-4.6) hours, inclusive of test runtime. From May 2020 to August 2022, we optimized the system to support rapid scale-up of SARS-CoV-2 testing (105 services; 6 jurisdictions; 71,823 tests) and additional sexually transmissible infection testing (16,232 tests), including the electronic disease-specific notifications to jurisdictional health departments and alerts for connectivity disruption and positive results. In 2022, 19,355 results were delivered with an overall median transmission time of 2.3 (IQR 1.4-3.1) hours, 2.2 (IQR 1.2-2.3) hours for SARS-CoV-2 (n=16,066), 3.0 (IQR 2.0-4.0) hours for CT/NG (n=1843), and 2.6 (IQR 1.5-3.8) hours for TV (n=1446). Demographic data (age, sex, and ethnicity) were completed for 99.5% of test results in 2022. CONCLUSIONS: This innovative connectivity system designed to meet end-user needs has proven to be sustainable, flexible, and scalable. It represents the first such system in Australia established independent of traditional pathology providers to support POC testing in geographically dispersed remote primary health services. The system has been optimized to deliver real-time test results and has proven critical for clinical, public health, and quality management. The system has significantly supported equitable access to rapid diagnostics for infectious diseases across Australia, and its design is suitable for onboarding other POC tests and testing platforms in the future.

Performance of four regression frameworks with varying precision profiles in simulated reference material commutability assessment.

OBJECTIVES: One approach to assessing reference material (RM) commutability and agreement with clinical samples (CS) is to use ordinary least squares or Deming regression with prediction intervals. This approach assumes constant variance that may not be fulfilled by the measurement procedures. Flexible regression frameworks which relax this assumption, such as quantile regression or generalized additive models for location, scale, and shape (GAMLSS), have recently been implemented, which can model the changing variance with measurand concentration. METHODS: We simulated four imprecision profiles, ranging from simple constant variance to complex mixtures of constant and proportional variance, and examined the effects on commutability assessment outcomes with above four regression frameworks and varying the number of CS, data transformations and RM location relative to CS concentration. Regression framework performance was determined by the proportion of false rejections of commutability from prediction intervals or centiles across relative RM concentrations and was compared with the expected nominal probability coverage. RESULTS: In simple variance profiles (constant or proportional variance), Deming regression, without or with logarithmic transformation respectively, is the most efficient approach. In mixed variance profiles, GAMLSS with smoothing techniques are more appropriate, with consideration given to increasing the number of CS and the relative location of RM. In the case where analytical coefficients of variation profiles are U-shaped, even the more flexible regression frameworks may not be entirely suitable. CONCLUSIONS: In commutability assessments, variance profiles of measurement procedures and location of RM in respect to clinical sample concentration significantly influence the false rejection rate of commutability.

29th Annual GP2A Medicinal Chemistry Conference.

The 29th Annual GP2A (Group for the Promotion of Pharmaceutical chemistry in Academia) Conference was a virtual event this year due to the COVID-19 pandemic and spanned three days from Wednesday 25 to Friday 27 August 2021. The meeting brought together an international delegation of researchers with interests in medicinal chemistry and interfacing disciplines. Abstracts of keynote lectures given by the 10 invited speakers, along with those of the 8 young researcher talks and the 50 flash presentation posters, are included in this report. Like previous editions, the conference was a real success, with high-level scientific discussions on cutting-edge advances in the fields of pharmaceutical chemistry.

The BACH project protocol: an international multicentre total Bile Acid Comparison and Harmonisation project and sub-study of the TURRIFIC randomised trial.

OBJECTIVES: Multicentre international trials relying on diagnoses derived from biochemical results may overlook the importance of assay standardisation from the participating laboratories. Here we describe a study protocol aimed at harmonising results from total bile acid determinations within the context of an international randomised controlled Trial of two treatments, URsodeoxycholic acid and RIFampicin, for women with severe early onset Intrahepatic Cholestasis of pregnancy (TURRIFIC), referred to as the Bile Acid Comparison and Harmonisation (BACH) study, with the aims of reducing inter-laboratory heterogeneity in total bile acid assays. METHODS: We have simulated laboratory data to determine the feasibility of total bile acid recalibration using a reference set of patient samples with a consensus value approach and subsequently used regression-based techniques to transform the data. RESULTS: From these simulations, we have demonstrated that mathematical recalibration of total bile acid results is plausible, with a high probability of successfully harmonising results across participating laboratories. CONCLUSIONS: Standardisation of bile acid results facilitates the commutability of laboratory results and collation for statistical analysis. It may provide the momentum for broader application of the described techniques in the setting of large-scale multinational clinical trials dependent on results from non-standardised assays.

A decentralised point-of-care testing model to address inequities in the COVID-19 response.

The COVID-19 pandemic is growing rapidly, with over 37 million cases and more than 1 million deaths reported by mid-October, 2020, with true numbers likely to be much higher in the many countries with low testing rates. Many communities are highly vulnerable to the devastating effects of COVID-19 because of overcrowding in domestic settings, high burden of comorbidities, and scarce access to health care. Access to testing is crucial to globally recommended control strategies, but many communities do not have adequate access to timely laboratory services. Geographic dispersion of small populations across islands and other rural and remote settings presents a key barrier to testing access. In this Personal View, we describe a model for the implementation of decentralised COVID-19 point-of-care testing in remote locations by use of the GeneXpert platform, which has been successfully scaled up in remote Aboriginal and Torres Strait Islander communities across Australia. Implementation of the decentralised point-of-care testing model should be considered for communities in need, especially those that are undertested and socially vulnerable. The decentralised testing model should be part of the core global response towards suppressing COVID-19.

The Benefits and Challenges of Point-of-Care Testing in Rural and Remote Primary Care Settings in Australia.

CONTEXT.­: Point-of-care (POC) testing has significant potential application in rural and remote Australian communities where access to laboratory-based pathology testing is often poor and the burden of chronic, acute, and infectious disease is high. OBJECTIVE.­: To explore the clinical, operational, cultural, and cost benefits of POC testing in the Australian rural and remote health sector and describe some of the current challenges and limitations of this technology. DATA SOURCES.­: Evidence-based research from established POC testing networks for chronic, acute, and infectious disease currently managed by the International Centre for Point-of-Care Testing at Flinders University are used to highlight the experience gained and the lessons learned from these networks and, where possible, describe innovative solutions to address the current barriers to the uptake of POC testing, which include governance, staff turnover, maintaining training and competency, connectivity, quality testing, sustainable funding mechanisms, and accreditation. CONCLUSIONS.­: Point-of-care testing can provide practical and inventive opportunities to revolutionize the delivery of pathology services in rural and remote sectors where clinical need for this technology is greatest. However, many barriers to POC testing still exist in these settings, and the full potential of POC testing cannot be realized until these limitations are addressed and resolved.

Sustained Quality and Service Delivery in an Expanding Point-of-Care Testing Network in Remote Australian Primary Health Care.

CONTEXT.­: Since 2008, the Northern Territory Point-of-Care Testing Program has improved patient access to pathology testing for acute and chronic disease management for remote health services. OBJECTIVE.­: To evaluate the analytical quality, service delivery, and clinical utility of an expanding remote point-of-care testing network. DESIGN.­: Four years (2016-2019) of data on analytical quality, test numbers, and training statistics and 6 months of clinical point-of-care testing data from Abbott i-STATs at remote health services throughout the Northern Territory were analyzed to assess analytical performance, program growth, and clinical utility. RESULTS.­: From 2016 to 2019, point-of-care test numbers increased, with chemistry and blood gas testing more than doubling to 8500 and 6000 tests, respectively, troponin I testing almost doubling (to 6000), and international normalized ratio testing plateauing at 8000 tests. Participation in quality control and proficiency testing was high, with quality comparable to laboratory-based analytical goals. A shift toward flexible training and communication modes was noted. An audit of point-of-care test results demonstrated elevated creatinine, associated with chronic kidney disease management, as the most common clinically actionable patient result. CONCLUSIONS.­: The Northern Territory Point-of-Care Testing Program provides high quality point-of-care testing within remote primary health services for acute and chronic patient management and care. Clinical need, sound analytical performance, flexibility in training provision, and effective support services have facilitated the sustainability of this expanding point-of-care testing model in the remote Northern Territory during the past 11 years.

Statistical methods used in the estimation of age-specific paediatric reference intervals for laboratory blood tests: A systematic review.

INTRODUCTION: There is an emerging realisation that paediatric reference intervals (RIs) estimated using discrete age-groups may be misleading, especially close to age cut-off values. This limitation has been addressed by estimating RIs that vary continuously with age. This systematic review examines the range of statistical methods used over the past 25 years for estimation of age-specific RIs, and identifies trends in usage and reporting. METHODS: Literature searches were conducted using predefined search criteria for original publications between 1993 and 2018 on the MEDLINE and Embase databases. Data related to sample size, treatment of age (as categorical or continuous), and statistical methods were extracted from the selected publications. RESULTS: A total of 238 publications were reviewed. Not all publications reported the statistical methods used in different steps. Among the publications, 167 (70%) reported discrete age-group RIs, 54 (23%) reported continuous RIs and 17 (7%) reported both types of RIs. The nonparametric statistical method was commonly used for discrete age-group RIs (64%, n = 117), whereas a wide variety of curve-fitting approaches, including Cole's lambda-mu-sigma method (28%, n = 20), parametric curve-based methods (28%, n = 20), generalised additive model for location, scale and shape method (13%, n = 9) and quantile regression (11%, n = 8) were used for continuous RIs. CONCLUSIONS: Improvement in the reporting of statistical methods used for estimating age-specific paediatric RIs is required. There has been insufficient uptake of methods for producing continuous RIs, especially for biomarkers that display strong age-dependence.

Validation of the HAPPI Kids Continuous Age-Specific Pediatric Reference Intervals.

INTRODUCTION: To facilitate best possible patient care, reference intervals (RIs) adopted by a laboratory must be appropriate for the population demographics and, where applicable, the analytical principle and/or the analytical instrument used. While guidelines from the Clinical and Laboratory Standard Institute (CLSI) recommend a validation process for discrete RIs, there are no current recommendations for the validation process for continuous RIs. This study aimed to validate recently published, HAPPI Kids continuous RIs, in a routine laboratory. METHODS: Initially, the difference in test results between the primary study laboratory that contributed to previous RIs development and a routine laboratory was assessed using specimens from 77 children tested in both laboratories using the Siemens ADVIA 1800 or Centaur/XP/XPT. Later, validation of the HAPPI Kids RIs was undertaken using 279 pediatric samples tested on the same analyzer type in the routine laboratory. The previously published RIs were validated if more than 90% of results in the routine laboratory were within the RIs. RESULTS: There was minimal evidence of clinically significant differences in test results between the primary and routine laboratories. The continuous RIs were validated after initial analysis for 16 of the 18 biochemistry analytes tested, and after secondary analysis for the remaining 2 analytes. CONCLUSION: This study validates the HAPPI Kids RIs in a routine laboratory, satisfying the laboratory accreditation requirements for evaluation, implementation, and sourcing of RIs. In addition, this study presents a modification of the current CLSI method for validation of continuous RIs that will benefit routine laboratories in general.

Paediatric Reference Intervals: Current Status, Gaps, Challenges and Future Considerations.

Establishing paediatric reference intervals (RIs) is a challenging task due to difficulties in subject recruitment, collection of adequate blood volume, and the inherent physiological changes of many biomarkers with age. Despite these challenges, several national and international initiatives have demonstrated: (a) the feasibility of prospectively designed paediatric RI studies; (b) the development of continuous RIs; and (c) the comparison of reference values across analyser types to harmonise paediatric RIs. Whilst these studies have improved the interpretation of paediatric test results and compliance with international accreditation (ISO15189) requirements, several gaps and challenges in translating current paediatric RIs into routine laboratory practice remain. Future priorities for paediatric RI studies include: (a) determination of the impact of discrete versus continuous RIs, analyser-specific versus harmonised RIs, and prospective collection versus data mining on the proportion of results outside the RIs; (b) understanding the clinical implications of analyser-to-analyser variation in reference values and use of evidence-based paediatric harmonised RIs where applicable; (c) adaptation of laboratory information systems to incorporate continuous RIs; (d) further understanding of the biological variation in paediatric biomarkers; (e) studies to address the paucity of accurate data for neonatal RI development; (f) periodic demonstration of RIs being clinically 'fit-for purpose'; and (g) agreement and policy updates for use of modern, best practice statistical methods in estimation of paediatric RIs. Furthermore, in vitro diagnostic manufacturers may require incentivised paediatric RI studies and publications through co-ordinated grants and collaboration at end-user sites to reduce the burden on sole users.

Reference intervals for serum cystatin C in neonates and children 30 days to 18 years old.

BACKGROUND: Serum cystatin C (CysC) is a promising biomarker of kidney function, which has higher accuracy and sensitivity when compared with creatinine. To better utilize serum CysC in clinical practice, this study aimed to establish continuous paediatric reference intervals (RIs) for serum CysC. METHODS: The study subjects consisted of healthy term neonates and children aged 30 days to 18 years. Venous blood samples were collected and serum CysC levels were measured using the immunoturbidimetric measurement principle. Fractional polynomial regression model and quantile regression was applied in the statistical analysis to generate continuous RIs. RESULTS: A total of 378 samples with equal numbers of males and females were analysed for serum CysC. No outliers were found in this analysis. The continuous RIs are presented as equations and graphical scatterplots. CONCLUSIONS: This study established continuous paediatric reference intervals (RIs) for serum CysC in healthy term neonates and children. The continuous RIs generated from this study show age-based dynamic changes as well as blood group and gender-specific differences for serum CysC. Graphical abstract.

Routine free thyroxine reference intervals are suboptimal for monitoring children on thyroxine replacement therapy and target intervals need to be assay-specific.

Central hypothyroidism is a condition where there is (qualitatively or quantitatively) TSH deficiency, leading to reduced thyroid hormone production. In such patients, serum TSH does not accurately reflect the adequacy of thyroxine replacement, as the log-linear relationship between thyrotropin (TSH) and free thyroxine (FT4) is lost. We aimed to prospectively determine the optimal physiological FT4 treatment range for children treated for primary hypothyroidism, based on their serum TSH concentrations. This information could be used to guide optimal therapy for all children on thyroxine replacement, including those with central hypothyroidism. In total, sixty children (median age: 11 years, range: 11 months to 18 years) were recruited over 21 months. They were prescribed a stable dose of thyroxine for at least 6-8 weeks prior to a thyroid function test that consisted of serum TSH, FT4 and free triiodothyronine (FT3) measurements. The serum sample for the thyroid function tests was collected before ingestion of the daily dose, i.e. the trough concentration, and measured using Beckman Coulter UniCel DxI 800 instrument, Siemens Advia Centaur, Roche Cobas, Abbott Architect, Ortho Clinical Diagnostics Vitros 5600 (Ortho-Clinical Diagnostics, Raritan, NJ) platforms. The FT4 and FT3 reference intervals showed significant inter-method difference. The lower limit of the FT4 reference intervals were generally shifted mildly higher when the TSH concentration of the children were restricted from 0.5-5.0 mIU/L to 0.5-2.5 mIU/L. By contrast, the upper limit of the FT3 and FT4 reference intervals were relatively stable for the different TSH concentrations. Assay-specific target ranges for optimal thyroxine therapy are required until FT4 assay standardisation is realised.

Reference Values for 30 Common Biochemistry Analytes Across 5 Different Analyzers in Neonates and Children 30 Days to 18 Years of Age.

BACKGROUND: Age-specific reference intervals (RIs) have been developed for biochemistry analytes in children. However, the ability to interpret results from multiple laboratories for 1 individual is limited. This study reports a head-to-head comparison of reference values and age-specific RIs for 30 biochemistry analytes for children across 5 analyzer types. METHODS: Blood was collected from healthy newborns and children 30 days to <18 years of age. Serum aliquots from the same individual were analyzed on 5 analyzer types. Differences in the mean reference values of the analytes by the analyzer types were investigated using mixed-effect regression analysis and by comparing maximum variation between analyzers with analyte-specific allowable total error reported in the Westgard QC database. Quantile regression was used to estimate age-specific RIs using power variables in age selected by fractional polynomial regression for the mean, with modification by sex when appropriate. RESULTS: The variations of age-specific mean reference values between analyzer types were within allowable total error (Westgard QC) for most analytes, and common age-specific reference limits were reported as functions of age and/or sex. Analyzer-specific reference limits for all analytes on 5 analyzer types are also reported as functions of age and/or sex. CONCLUSIONS: This study provides quantitative and qualitative measures of the extent to which results for individual children can or cannot be compared across analyzer types, and the feasibility of RI harmonization. The reported equations enable incorporation of age-specific RIs into laboratory information systems for improving evidence-based clinical decisions in children.

Lower limb vascular assessment techniques of podiatrists in the United Kingdom: a national survey.

BACKGROUND: Podiatric vascular assessment practices in the United Kingdom (UK) are currently unknown. This study aimed to describe the current practices for performing lower limb vascular assessments by podiatrists in the UK, and, to investigate the effect of practitioner characteristics, including education level and practice setting, on the choice of tests used for these assessments. METHODS: A cross-sectional observational online survey of registered podiatrists in the UK was conducted using SurveyMonkey® between 1st of July and 5th of October 2018. Item content related to: practitioner characteristics, vascular testing methods, barriers to completing vascular assessment, interpretation of vascular assessment techniques, education provision and ongoing management and referral pathways. Descriptive statistics were performed, and multinomial logistic regression analyses were used to determine whether practitioner characteristics could predict the choice of vascular tests used. RESULTS: Five hundred and eighty five participants accessed the online survey. After drop-outs and exclusions, 307 participants were included in the analyses. Comprehensive vascular assessments had most commonly been performed once (15.8%) or twice (10.4%) in the past week. The most common indicators for performing vascular assessment were symptoms of suspected claudication (89.3%), suspected rest pain (86.0%) and history of diabetes (85.3%). The most common barrier to performing vascular assessment was time constraints (52.4%). Doppler examination (72.3%) was the most frequently reported assessment type, with ankle-brachial index (31.9%) and toe brachial index (5.9%) less frequently performed. There were variable interpretations of vascular test results. The most common topic for education was smoking cessation (69.5%). Most participants (72.2%) were confident in determining ongoing management, with the majority referring to the patient's general practitioner (67.6%). Practitioner characteristics did not predict the types of vascular tests performed. CONCLUSION: The majority of vascular assessments currently performed by podiatrists in the UK are inconsistent with UK or international vascular guidelines and recommendations. Despite this, most podiatrists felt confident in diagnosing, referring and managing patients with peripheral arterial disease (PAD), however many felt they needed more education to feel confident to assist patients with PAD to manage their cardiovascular risk factors.