Metabolic syndrome is prevalent and undiagnosed in clients attending private practice physiotherapy: a cross-sectional study.

OBJECTIVES: To determine the prevalence of metabolic syndrome in clients presenting for primary care physiotherapy within private practice settings, and the factors that may be associated with metabolic syndrome. The secondary aim was to determine client's attitudes towards lifestyle change. DESIGN: A cross-sectional study in which self-report and biometric data were collected. The study was conducted in physiotherapy private practices across metropolitan and regional areas, Australia. PARTICIPANTS: 230 clients (mean age 54 (SD18) years, 64% women) presenting for physiotherapy participated. MAIN OUTCOME MEASURES: Participant socio-demographic and lifestyle characteristics were collected. Metabolic syndrome presence was determined by the existence of three or more risk factors on physical examination and capillary blood sample: abdominal obesity, hypertension, elevated random blood glucose, elevated triglycerides and/or reduced HDL cholesterol. RESULTS: Thirty-seven percent of participants had metabolic syndrome, but none knew they had it. Metabolic syndrome was associated with older age and poorer socio-economic status and may have been associated with lower levels of physical activity but not diet. Of those identified as having hypertension and elevated triglycerides, many were undiagnosed (56% and 29% respectively). CONCLUSION: Metabolic syndrome is prevalent and undiagnosed in clients attending private practice physiotherapy. Clients felt lifestyle change was important and they were willing to make changes. This study highlights the need for greater screening of metabolic risk factors in primary care and presents an opportunity for physiotherapists in private practice to identify risk and intervene to improve the overall health of their clients and contribute to chronic disease prevention. CONTRIBUTION OF THE PAPER.

"You don't know what you don't know": Knowledge, attitudes, and current practice of physiotherapists in recognising and managing metabolic syndrome, a mixed methods study.

OBJECTIVES: To determine the knowledge, attitudes, and current practice of primary care physiotherapists in recognising and managing clients with metabolic syndrome. DESIGN: Mixed-methods research design comprising an online survey and focus groups. PARTICIPANTS: Australian and English physiotherapists (n = 183) working in a primary care setting responded to the survey. Twelve physiotherapists participated in focus groups. RESULTS: Metabolic syndrome was not on physiotherapists radar. They did not screen for metabolic syndrome nor provide management for it in primary care. Although most physiotherapists had some awareness of metabolic syndrome, they were not knowledgeable. Physiotherapists reported a need to focus on their clients' presenting condition, and there was uncertainty on whether metabolic syndrome management was within their scope of practice. Despite this, physiotherapists felt they had an important role to play in exercise and physical activity prescription for chronic disease management and were keen to further their knowledge and skills related to metabolic syndrome. Survey responses and focus group data were convergent. CONCLUSION: Physiotherapists working in primary care settings are well-placed to identify metabolic risk factors in their clients and provide physical activity interventions to enhance management but currently lack knowledge to embed this in clinical practice. Training and resources are required to enable physiotherapists to identify and manage metabolic syndrome within their practice. CONTRIBUTION OF PAPER.

"It Makes You Feel Alive and Younger but It's Stressful My Back and Legs Ache": A Focus Group Study Encouraging Resistance Training Around Retirement.

Muscle weakness is a key component of age-related conditions such as sarcopenia and frailty. Resistance training is highly effective at preventing and treating muscle weakness; however, few adults meet recommended levels. Retirement may be a key life-stage to promote resistance training. We carried out a virtual focus group study to explore motivators and barriers to resistance training around the time of retirement, with the aim of determining strategies and messages to increase its uptake. The five focus groups (n = 30) were recorded, transcribed and thematically analysed. We found that resistance training was positively viewed when associated with immediate and long-term health and wellbeing benefits and had a social dimension; but there was a lack of understanding as to what constitutes resistance training, the required intensity level for effects; the role of pain; and the consequences of muscle weakness.

Physiotherapy-Led Health Promotion Strategies for People with or at Risk of Cardiovascular Diseases: A Scoping Review.

Cardiovascular diseases (CVD) are prevalent and lead to high morbidity and mortality globally. Physiotherapists regularly interact with patients with or at risk of CVDs (pwCVDs). This study aimed to assess the nature of existing evidence, interventional approaches used, and the population groups included in physiotherapy-led health promotion (PLHP) for pwCVDs. The scoping review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines. Medline, PubMed, Web of Science, Cochrane Central Register of Controlled Trials, CINAHL, and PEDro databases were searched from inception until June 2023. Two reviewers independently screened the titles, abstracts, and full text and conducted data extraction. All conflicts were resolved with a third reviewer. A total of 4992 records were identified, of which 20 full-text articles were included in the review. The studies had varied populations, including those with stroke, coronary artery diseases, peripheral artery diseases, hypertension, diabetes, and multiple CVD risk factors. The interventions ranged from exercise and physical activity programmes, dietary interventions, education, and counselling sessions with various supplementary approaches. Most interventions were short-term, with less than 12 months of follow-up. Interventions were personalised and patient-centred to promote adherence and health behaviour change. Among the included studies, 60% employed experimental designs, with the remainder using quasi-experimental designs. Although a wide range of PLHP strategies have been used for pwCVDs, exercise and physical activity were employed in 85% of the included studies. Other components of health promotion, such as sleep, smoking, and alcohol abuse, should be investigated within PLHP.

Trust and trustworthy artificial intelligence: A research agenda for AI in the environmental sciences.

Demands to manage the risks of artificial intelligence (AI) are growing. These demands and the government standards arising from them both call for trustworthy AI. In response, we adopt a convergent approach to review, evaluate, and synthesize research on the trust and trustworthiness of AI in the environmental sciences and propose a research agenda. Evidential and conceptual histories of research on trust and trustworthiness reveal persisting ambiguities and measurement shortcomings related to inconsistent attention to the contextual and social dependencies and dynamics of trust. Potentially underappreciated in the development of trustworthy AI for environmental sciences is the importance of engaging AI users and other stakeholders, which human-AI teaming perspectives on AI development similarly underscore. Co-development strategies may also help reconcile efforts to develop performance-based trustworthiness standards with dynamic and contextual notions of trust. We illustrate the importance of these themes with applied examples and show how insights from research on trust and the communication of risk and uncertainty can help advance the understanding of trust and trustworthiness of AI in the environmental sciences.

External Quality Assessment Data for Investigation of von Willebrand Disease: Focus on Relative Utility of Contemporary Functional von Willebrand Factor Assays. The United Kingdom National External Quality Assessment Scheme (UK NEQAS) Experience.

Von Willebrand disease (VWD) is one of the most common hereditary bleeding disorders. Effective management of patients and their families depends on accurate diagnosis and subtype classification, and quality assurance including participation in proficiency testing programs is essential to ensure the accuracy of the panel of assays required to achieve this diagnosis. We report here findings from recent external quality assessment (EQA) exercises, as well as from a questionnaire about diagnostic practices employed by centers in the United Kingdom National Quality Assessment Scheme (UK NEQAS) performing von Willebrand factor (VWF) assays. Plasma samples from donors with VWD, "normal" donors, the International Society for Thrombosis and Haemostasis Scientific Subcommittee (ISTH SSC) plasma standard, and whole blood samples were sent to participants in the UK NEQAS BC program for VWF investigation. Calibration of lot#5 of the ISTH SSC plasma standard was shown to give improved comparability between the recovered value from an EQA exercise and the assigned potency for VWF activity assays. Diagnostic accuracy and precision amongst UK NEQAS participants was good, with an average 99% of centers reporting the correct interpretation for normal, type 1 and type 2 VWD samples, 100% diagnostic accuracy for centers performing FVIII binding assays, and good agreement amongst centers performing multimeric analysis. Genetic analysis of the VWF gene by specialist centers demonstrated errors in the genotyping process in one center, but also demonstrated failings in the interpretation of results in other centers. Despite evidence of good laboratory accuracy and precision in their assays, a questionnaire identified marked variation in diagnostic criteria employed, underlining the importance of guidelines to support the diagnosis of VWD.

Understanding the Needs and Priorities of People Living with Persistent Pain and Long-Term Musculoskeletal Conditions during the COVID-19 Pandemic-A Public Involvement Project.

BACKGROUND: Critiques of public involvement (PI) are associated with failing to be inclusive of under-represented groups, and this leads to research that fails to include a diversity of perspectives. AIM: The aim of this PI project was to understand the experiences and priorities of people from three seldom-heard groups whose musculoskeletal pain may have been exacerbated or treatment delayed due to COVID-19. Engaging representatives to report diverse experiences was important, given the goal of developing further research into personalised and integrated care and addressing population health concerns about access and self-management for people with musculoskeletal pain. METHODS: The project was approved via Sheffield Hallam University Ethics but was exempt from further HRA approval. A literature review was conducted, followed by informal individual and group discussions involving professionals and people with lived experience of (a) fibromyalgia pain, (b) those waiting for elective surgery and (c) experts associated with the care home sector. Findings from the literature review were combined with the insights from the public involvement. Resulting narratives were developed to highlight the challenges associated with persistent pain and informed the creation of consensus statements on the priorities for service improvement and future research. The consensus statements were shared and refined with input from an expert steering group. RESULTS: The narratives describe pain as a uniformly difficult experience to share with professionals; it is described as exhausting, frustrating and socially limiting. Pain leads to exclusion from routine daily activities and often resigns people to feeling and being unwell. In all cases, there are concerns about accessing and improving services and critical issues associated with optimising physical activity, functional wellbeing and managing polypharmacy. Exercise and/or mobilisation are important and commonly used self-management strategies, but opportunity and advice about safe methods are variable. Services should focus on personalised care, including self-management support and medication management, so that people's views and needs are heard and validated by health professionals. CONCLUSIONS: More research is needed to explore the most effective pain management strategies, and public involvement is important to shape the most relevant research questions. Health and care systems evaluation is also needed to address the scale of the population health need. The pandemic appears to have highlighted pre-existing shortcomings in holistic pain management.

Physical activity promotion by GPs: a cross-sectional survey in England.

BACKGROUND: Physical activity (PA) contributes to the prevention and management of many health conditions. Primary care practitioners have an important role to play in supporting people to be physically active. AIM: This study had the following three aims: 1) to explore GPs' awareness and knowledge of the PA guidelines; 2) to assess GPs' confidence in promoting PA; and 3) to explore factors that influence PA promotion among GPs. DESIGN & SETTING: Cross-sectional survey, using secondary analysis. METHOD: UK-based GPs were invited to take part in an online survey in January 2021. Demographic questions were followed by nine multiple choice questions. Categorical data were analysed using descriptive statistics, and open-ended data were analysed using content analysis and inductive coding. RESULTS: In total, 839 GPs based in England completed the survey. Most GP responders (98.9%) believed that PA was important, yet only 35.7% reported being at least 'somewhat familiar' with current PA guidance. Despite this, 74.1% of GPs reported feeling confident raising the topic of PA with their patients. Barriers included lack of time, perceptions of patient attitude and risk, language issues, and COVID-19. Key facilitators were identified and 'Couch to 5k' and the 'parkrun practice' initiatives were the most widely used support tools. CONCLUSION: GPs value PA yet well-known barriers exist to embedding promotion into primary care. As primary care reconfigures, there is an opportunity to embed PA into systems, services, and processes.

Advantages of external quality assessment-EQA programs.

INTRODUCTION: The first external quality assessment (EQA) in Thrombosis and Haemostasis was elaborated over 20 years ago, and since then, several national and international EQA institutions have been established. AIM: Display the benefits of EQA programs. METHODS: The spectrum of EQA action was evaluated ranges from improving the performance of the local laboratory to highlighting inadequate diagnostic tests that need to be replaced by new technologies. RESULTS: The first result approach is related to a national management of quality in laboratories. In recent years, Brazil has invested in an EQA program to aid public policy in the laboratory area. During this period, a group of haemostasis laboratory specialists were invited to manage the results and help the Ministry of Health with applying these results as a strategy to improve laboratories. Thus, in collaboration with NEQAS-BC, the University of Campinas - UNICAMP, established a Brazilian EQA program for Blood Coagulation. The second result approach is related to FVIII inhibitor assay performance evaluation, which is another type of EQA program benefit. Despite the assay being considered the gold standard to measure neutralised immunoglobulins for FVIII since 1975, over 40 years ago, the test still has a high coefficient of variation. Results from NEQAS-BC and WFH IEQAS program demonstrate the inter-laboratory variation across the United Kingdom over the last years and among emergent countries. CONCLUSION: The EQA programs have an important educational role in helping countries manage their public policy and in the international inquiry regarding the necessity of new technologies in haemostasis.

Von Willebrand factor assays in patients with acquired immune thrombotic thrombocytopenia purpura treated with caplacizumab.

Acquired immune thrombotic thrombocytopenic purpura (iTTP) is a rare disease with a poor prognosis if undiagnosed. It is caused by autoantibody production to the von Willebrand factor (VWF) cleaving protease, A disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13). Caplacizumab, an immunoglobulin directed to the platelet glycoprotein Ibα receptor of VWF, has been reported to induce quicker resolution of iTTP compared to placebo. The laboratory measurement of VWF activity was significantly reduced in clinical trials of caplacizumab. Several VWF assays are available in the UK and this study investigated whether differences in VWF parameters were present in 11 patients diagnosed with iTTP and treated with daily caplacizumab. Chromogenic factor VIII activity, VWF antigen, collagen binding activity, VWF multimers and six VWF activity assays were measured prior to caplacizumab therapy and on several occasions during treatment. VWF antigen and collagen binding activity levels were normal or borderline normal in all patients. Ultra-large molecular weight multimers were present in all patients following treatment. VWF activity assays were normal or reduced during treatment, but this was reagent and patient dependant. In the unusual scenario of a caplacizumab-treated patient requiring measurement of VWF activity, it is important that laboratories understand how their local reagents perform as results cannot be predicted.

Multicenter performance evaluation and reference range determination of a new one-stage factor VIII assay.

INTRODUCTION: We conducted a multicenter evaluation of a new one-stage factor VIII (FVIII) assay (Roche Diagnostics), intended for the quantitative assessment of FVIII activity. We evaluated the analytical performance of the FVIII assay on the cobas t 711 analyzer. METHODS: Experiments performed at three laboratories used 3.2% citrated residual or commercially purchased plasma samples. Five human plasma pools and two controls were used to determine assay within-run and within-laboratory precision, and total reproducibility; coefficients of variation (CVs) and/or standard deviations (SDs) were calculated. Lot-to-lot variability and method comparison (vs Coagulation FVIII Deficient Plasma/Dade Actin FS Activated PTT reagent/Standard Human Plasma Calibrator on the Sysmex CS-5100 analyzer; Siemens Healthineers) were evaluated by Passing-Bablok and Deming regression, respectively, and Pearson's r calculated. Assay-specific reference range was determined using 199 fresh plasma samples from healthy adults, not receiving anticoagulants. RESULTS: Across sites, SDs for repeatability were 0.016-0.046 for samples with ≤1.0 international units (IU)/dL FVIII activity; CVs were 0.9%-3.8% for samples with >1.0 IU/dl activity. Among samples with mean FVIII activity 0.344-133 IU/dl, good intermediate precision (SD 0.020 for samples with 0.344 IU/dl activity; CV 1.8%-4.7%) and good total reproducibility (CV 2.0%-13.3%) were observed. The FVIII assay showed excellent lot-to-lot variability (Pearson's r = .999) and good correlation with the comparator assay (Pearson's r = .993-.996). The reference range for FVIII activity was 82.2-218.0 IU/dl. CONCLUSION: The one-stage FVIII assay demonstrated robust analytical performance on the cobas t 711 analyzer, supporting its use in routine laboratory practice.

Laboratory coagulation tests and recombinant porcine factor VIII: A United Kingdom Haemophilia Centre Doctors' Organisation guideline.

INTRODUCTION: Acquired haemophilia A (AHA) is a rare bleeding disorder caused by development of auto-antibodies to endogenous coagulation factor VIII (FVIII). Recombinant porcine factor VIII (rpFVIII) is currently licensed only for the management of bleeding in patients with AHA. Regular monitoring of rpFVIII is recommended to assess treatment effectiveness. AIM: This guideline from the United Kingdom Haemophilia Centre Doctors' Organisation (UKHCDO) examines the current publications in the area and aims to offer advice for the laboratory monitoring of rpFVIII in patients with AHA. METHODS: A review of the current literature was undertaken followed by critical review by the authors. RESULTS/CONCLUSIONS: A validated one-stage clotting FVIII assay is recommended for the measurement and regular monitoring of rpFVIII. Assessment of cross-reacting rpFVIII inhibitors by one-stage porcine Bethesda assay should be performed as part of the initial diagnosis of AHA or prior to treatment with rpFVIII. Available data show that chromogenic FVIII assays underestimate rpFVIII and this should be considered if measurement of rpFVIII is required in patients receiving Emicizumab.

External quality assessment for one-stage and chromogenic factor IX assays in samples containing Alprolix (rFIXFc) or Idelvion (rIX-FP) and evidence that UK National External Quality Assessment Scheme for blood coagulation samples are commutable with patient samples.

INTRODUCTION: There may be clinically relevant differences between results of different FIX assays in samples containing extended half life FIX concentrates requiring regular surveillance of assay results through proficiency testing exercises. Control materials used in proficiency testing must be commutable, that is have the same inter-assay properties as those demonstrated by authentic clinical samples when measured by different analytical methods. METHODS: We assessed relationships between results with different FIX assays and commutability of UK National External Quality Assessment Scheme (NEQAS) materials containing rIX-FP (Idelvion) or rFIXFc (Alprolix) by comparing results obtained using widely used one-stage and chromogenic assays during a proficiency testing exercise with results obtained when analysing a series of individual patient samples using the same assay systems. NEQAS samples prepared by addition of either Idelvion or Alprolix to FIX deficient plasma were sent to 76 haemophilia centres in Europe. A total of 18 Idelvion and 22 Alprolix patient samples were assayed in a single centre. Two chromogenic and two one-stage assays were compared. RESULTS: The pattern of results obtained for NEQAS samples and patient samples was similar. In all cases, the NEQAS sample data point was within the scatter of patient sample data in plots of patient sample results showing one-stage assay results using Synthasil or Actin FS plotted against chromogenic assay results with Biophen or Rox chromogenic FIX kits. CONCLUSION: This indicates that the NEQAS samples containing Idelvion or Alprolix were commutable and therefore suitable for use in proficiency testing exercises.

The Active Hospital pilot: A qualitative study exploring the implementation of a Trust-wide Sport and Exercise Medicine-led physical activity intervention.

BACKGROUND: In 2017 Public Health England and Sport England commissioned a Consultant-led Sport and Exercise Medicine (SEM) pilot to test the feasibility and acceptability of embedding physical activity interventions in secondary care clinical pathways. The aim of this paper is to report qualitative findings exploring the experience of healthcare professionals (HCPs) and patients involved in the Active Hospital pilot. METHODS: Qualitative data was collected by semi-structured interviews with Active Hospital pilot SEM Consultants, and staff and patients involved in three clinical pathways. Interviews with SEM Consultants explored the experience of developing and implementing the pilot. Interviews with staff and patients explored the experience of delivering and receiving Active Hospital interventions. Data were analysed thematically. RESULTS: Interviews identified the importance of the Active Hospital pilot being Consultant-led for the following reasons; i) having trusting relationships with decision makers, ii) having sufficient influence to effect change, iii) identifying champions within the system, and iv) being adaptable to change and ensuring the programme fits within the wider strategic frameworks. HCPs emphasised the importance of the Active Hospital interventions fitting easily within existing work practices, the need for staff training and to tailor interventions for individual patient needs. The Active Hospital pilot was well received by patients, however a lack of dedicated resource and capacity to deliver the intervention was highlighted as a challenge by both patients and HCPs. CONCLUSION: The SEM Consultants' ability to navigate the political climate of a large National Health Service (NHS) Trust with competing agendas and limited resource was valuable. The interventions were well received and a valued addition to usual clinical care. However, implementation and ongoing delivery of the pilot encountered challenges including lack of capacity within the system and delays with recruiting to the delivery teams in each pathway.

Laboratory issues in gene therapy and emicizumab.

The treatment options for the haemostatic disorders, haemophilia A and haemophilia B, have progressed rapidly over the last decade. The introduction of extended half-life recombinant factor VIII (FVIII) and factor IX (FIX) concentrates to replace these missing clotting factors highlighted discordance between one-stage activated partial thromboplastin time (APTT)-based clotting factor assays and chromogenic factor assays with some products. This raised awareness of the importance of investigation of potential reagent or assay differences by pharmaceutical companies. In 2017, the FVIII mimetic, emicizumab, was approved as a prophylactic treatment for haemophilia A patients with anti-FVIII inhibitors. The mechanism of action of emicizumab causes interference with some commonly used haemostasis tests including the APTT and its associated one-stage APTT-based clotting assays. Chromogenic assays may also be affected but this is dependent on the particular constituents of the reagents. Chromogenic assays containing human factor IXa (FIXa) and factor X (FX) are sensitive to the presence of emicizumab but those containing bovine FIXa and FX are unaffected. Many haemostasis laboratories have been required to evaluate new assays to enable accurate monitoring of emicizumab in patient plasma. A number of gene therapy approaches have been trialled in both haemophilia A and haemophilia B but there are scant data published on the measurement of FVIII and FIX in these patients and whether there are discrepancies between reagents or assay methodologies.

Effects of Enriched Physical Activity Environments on Balance and Fall Prevention in Older Adults: A Scoping Review.

The incidence of falling, due to aging, is related to both personal and environmental factors. There is a clear need to understand the nature of the major risk factors and design features of a safe and navigable living environment for potential fallers. The aim of this scoping review was to identify studies that have examined the effectiveness of environments, which promote physical activity and have an impact on falls prevention. Selected studies were identified and categorized into four main topics: built environment, environment modifications, enriched environments, and task constraints. The results of this analysis showed that there are a limited number of studies aiming to enhance dynamic postural stability and fall prevention through designing more functional environments. This scoping review study suggests that the design of interventions and the evaluation of an environment to support fall prevention are topics for future research.

Effects of Emicizumab on APTT, FVIII assays and FVIII Inhibitor assays using different reagents: Results of a UK NEQAS proficiency testing exercise.

INTRODUCTION: Emicizumab (Hemlibra: Roche Switzerland) is a, humanized, bi-specific monoclonal modified immunoglobulin G4 (IgG4) which binds human FX, FIX and activated FIX (FIXa) to mimic activated FVIII activity. AIM: Evaluate the effects of emicizumab on the APTT, surrogate FVIII activity and FVIII inhibitor results. METHODS: Two samples were provided, one obtained from an emicizumab treated severe haemophilia A patient with FVIII inhibitors and one constructed by in vitro addition of emicizumab using plasma from a severe haemophilia A patient without FVIII inhibitors. An APTT screen, surrogate FVIII and FVIII inhibitor tests were performed on both samples by participating centres. RESULTS: APTT results were below the lower limit of normal range. Chromogenic FVIII assay results with the Hyphen/Biophen human component-based assay gave higher than expected coefficient of variation (CV) results, 38%-40%. The modified one-stage FVIII assay with emicizumab calibrators showed similar results regardless of the APTT reagent. Inhibitor assay median results for sample S18:23 = 1.43 BU (range 0.9-3.0 BU/ml, CV 38%). S18:24 was classified as below the lower limit of detection. CONCLUSION: APTT screens showed a consistent shortening. Unmodified one-stage Factor VIII assay results were remarkably high. APTT-based assays are unsuitable for measurement of coagulation factors or inhibitors in patients treated with emicizumab. Bovine origin chromogenic assays are insensitive to emicizumab and should be used to monitor FVIII levels/FVIII inhibitors in emicizumab treated patients. Product-specific calibrators should be implemented to reduce result variability.

System performance evaluation of the cobas t 711 and cobas t 511 coagulation analyzers in routine laboratory settings.

: Utility of coagulation analyzers in real-world settings depends on characteristics that are often not studied comprehensively. This study aimed to investigate the analytical performance, system functionality, practicability, consistency and throughput of two new automated coagulation analyzers in routine laboratory practice. Real-world settings were simulated in three major European hemostasis laboratories and multiple assays were performed in anonymized plasma samples in parallel with routine clinical practice on the cobas t 711 (high-throughput) and cobas t 511 (mid-throughput) analyzers using activated partial thromboplastin time (aPTT), aPTT Lupus, aPTT Screen, Antithrombin (AT), D-Dimer, Fibrinogen, Prothrombin Time (PT)-derived Fibrinogen, PT Owren, PT Rec (recombinant human thromboplastin reagent) and Thrombin Time assays. Precision was tested in a 21-day experiment and accuracy was compared with reference methods of the same laboratory. A number of experiments simulated challenging real-life situations. Pearson's correlation coefficient was more than 0.98 in all assays. Across assays, coefficients of variation ranged from 0.0 to 1.5% for intermediate precision; 0.2 to 3.0% for repeatability and 0.4 to 3.7% for total precision. Good between-run comparability was seen when testing samples under random conditions. Calculated maximum throughput was 197 and 387-402 tests/h for the cobas t 511 and 711 analyzers, respectively. Practicability met or exceeded user expectations in 98% of cases. In a simulated real-life setting of three major laboratories, the new cobas t 511 and cobas t 711 coagulation analyzers demonstrated a good functionality, practicability and performance and the throughput was high.

Evaluating the analytical performance of five new coagulation assays for the measurement of prothrombin time and activated thromboplastin time.

INTRODUCTION: New methods for coagulation tests require careful assessment before routine use. We evaluated the analytical performance of five new coagulation assays for measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT). METHODS: PT Rec, PT Owren, aPTT, aPTT Lupus and aPTT Screen assays (Roche Diagnostics) were evaluated on cobas t 711 and cobas t 511 analysers (Roche Diagnostics) at four European centres. Analytical performance and method comparisons with relevant commercially available assays were performed to Clinical Laboratory Standards Institute guidelines using residual anonymized samples. Lot-to-lot comparison and equivalency of the cobas t analysers were also assessed; reference ranges were determined using samples from apparently healthy volunteers. RESULTS: Overall, coefficients of variation were ≤1.3% for within-run precision and ≤6.3% for total reproducibility across all sites. Deming regression analyses showed good agreement between each assay (cobas t 711) and respective comparator method (Pearson's r: 0.964-0.999, n > 120 samples/assay/site). Passing-Bablok regression analyses demonstrated equivalence of the two cobas t platforms for use with each assay (Pearson's r ≥ 0.995). Lot-to-lot consistency was high for all assays and comparisons (Pearson's r ≥ 0.998). Reference ranges (2.5th-97.5th percentiles; n = 200 samples/assay) in seconds were 8.4-10.6 (PT Rec), 18.2-27.2 (PT Owren), 23.6-30.6 (aPTT), 24.1-31.7 (aPTT Lupus) and 23.9-33.2 (aPTT Screen). CONCLUSION: Based on the excellent analytical performance and good agreement with relevant comparator methods, the five coagulation assays on the novel cobas t 711 and cobas t 511 analysers are suitable for routine use in core laboratories.