Dipsticks and point-of-care Microscopy to reduce antibiotic use in women with an uncomplicated Urinary Tract Infection (MicUTI): protocol of a randomised controlled pilot trial in primary care
Peter K KurotschkaGábor BorgulyaE. BucherIsabell EndrichAdolfo FigueirasJochen GensichenAlastair D HayAlexander HapfelmeierChristian KretzschmannOliver KurzaiThiên‐Trí LâmOrietta MassiddaLinda SanftenbergGuido SchmiemannAntonius SchneiderAnne SimmenrothStefanie StarkLisette WarkentinMark H. EbellIldikó Gágyor
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Introduction Uncomplicated urinary tract infections (uUTIs) in women are common infections encountered in primary care. Evidence suggests that rapid point-of-care tests (POCTs) to detect bacteria and erythrocytes in urine at presentation may help primary care clinicians to identify women with uUTIs in whom antibiotics can be withheld without influencing clinical outcomes. This pilot study aims to provide preliminary evidence on whether a POCT informed management of uUTI in women can safely reduce antibiotic use. Methods and analysis This is an open-label two-arm parallel cluster-randomised controlled pilot trial. 20 general practices affiliated with the Bavarian Practice-Based Research Network (BayFoNet) in Germany were randomly assigned to deliver patient management based on POCTs or to provide usual care. POCTs consist of phase-contrast microscopy to detect bacteria and urinary dipsticks to detect erythrocytes in urine samples. In both arms, urine samples will be obtained at presentation for POCTs (intervention arm only) and microbiological analysis. Women will be followed-up for 28 days from enrolment using self-reported symptom diaries, telephone follow-up and a review of the electronic medical record. Primary outcomes are feasibility of patient enrolment and retention rates per site, which will be summarised by means and SDs, with corresponding confidence and prediction intervals. Secondary outcomes include antibiotic use for UTI at day 28, time to symptom resolution, symptom burden, number of recurrent and upper UTIs and re-consultations and diagnostic accuracy of POCTs versus urine culture as the reference standard. These outcomes will be explored at cluster-levels and individual-levels using descriptive statistics, two-sample hypothesis tests and mixed effects models or generalised estimation equations. Ethics and dissemination The University of Würzburg institutional review board approved MicUTI on 16 December 2022 (protocol n. 109/22-sc). Study findings will be disseminated through peer-reviewed publications, conferences, reports addressed to clinicians and the local citizen’s forums. Trial registration number ClinicalTrials.gov NCT05667207 .Keywords:
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Background: Use of point-of-care testing (POCT) in primary care has increased. There is a need for high-quality field evaluation of POCT before deployment can be considered. Method: A POCT system for C-reactive protein was evaluated in a routine general practice setting. The standard laboratory method was a dry slide method based in a routine hospital laboratory. Results: Scatterplots for both venous and capillary blood POCT system results versus the standard laboratory assay produced correlation coefficients of greater than 0·96. Bland-Altman plots indicated that 95% of venous and capillary POCT results fell within ±10 mg/L of the mean value with no clinically significant difference from laboratory results. Conclusions: The POCT system performed reliably in a routine general practice setting with satisfactory performance against an accepted laboratory method.
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POCT（point of care testing）は，臨床現場で検査が即時に行われ，結果が即時に臨床に利用されるシステムである．救急医療では，臨床検査には，①迅速性，②簡便性，③随時性ならびに④反復性を求められるが，POCTはこれらの全ての要件を満たしている．一方，急性冠症候群の診療における第一選択の心筋マーカーは心筋トロポニン，特に高感度トロポニンである．高感度トロポニン上昇例では，心筋梗塞とそれ以外の病態に起因する心筋傷害との鑑別が不可欠である．
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There has been much interest in improving the accuracy and speed with which chest pain patients presenting to the emergency department are diagnosed and treated. Recently, attention has been directed toward alternative site or point-of-care testing for biochemical markers of myocardial cell necrosis in addition to traditional diagnostic methodologies. The various point-of-care cardiac marker devices available and their potential applications are discussed. Regulatory and quality management issues related of point-of-care testing are reviewed.
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Objective Observation has led us to believe that urinary tract infections (UTI) may be difficult to diagnose from a dilute urine specimen. We conducted this study to determine the effect of urine concentration on identifying UTI based on urinalysis (UA) results. Methods We reviewed the UA results of febrile children under 36 months of age with positive urine cultures. We …
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Point-of-care testing provides current, accurate information relating to thrombosis and hemostasis in patients. Several forces are driving point-of-care testing, particularly economic factors and improved technology. Point-of-care testing has the potential to improve patient management and to decrease integrated costs, although this remains to be shown. For such testing to be successful, the technology must be complemented by hospital-wide point-of-care testing programs. The role of the laboratorian and pathologist will become important for coordinating programs, maintaining quality assurance, and promoting quality improvement.
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Urinary tract infection (UTI) is defined as the presence of bacteria in urine along with symptoms of infection.UTIs occurs in 1.1% of girls and 1.4% of boys in the first year of life. The aim of the study was to assessthe usefulness of measurement of pro-inflammatory interleukin (IL)-6 and IL -8 concentrations in the urineand serum of children with UTI. A total of Eighty serum sample and seventy tow urine sample have beencollected from children with urinary tract infection, Their age ranged between 33days- 12 years old, fifty sixchildren of the same age collected as controls .Urine and serum IL-6 and IL-8 concentrations of both groupswere measured and compared. Urine and serum concentrations of IL -8 were significantly higher in childrenwith UTI compared with controls group (P = 0.0001, P = 0.0002) respectively, while there was no significantdifferent in urine and serum concentration of IL-6 of children with UTI and controls group(P = 0.1199 , P=0.572) respectively. The results demonstrate that IL-8 is a good biomarker for urinary tract infection, whileIL-6 is not.
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Aim: Bedside or point-of-care testing (POCT) provides immediate results, allowing for rapid clinical decision making and management of critically ill patients. IL-6 is a central mediator in cytokine release syndrome and sepsis, two potentially life-threatening events. A real-time point-of-care measurement of IL-6 readily available in hospitals and/or to clinicians could provide a valuable tool for decision making. Materials & methods: An IL-6 assay is developed on a POCT device (Proxim, CA, USA), with comparison data measured by ELISA, Ella, and the Roche Cobas. Results: Samples evaluated on a Proxim POCT device showed good correlation with data from multiple platforms. Conclusions: An IL-6 point-of-care assay was developed as potential tool for rapid clinical decision making and management of patients with sepsis and/or cytokine release syndrome.
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PART I. INTRODUCTIONPoint-of-Care Testing in the 21st CenturyGoals and Guidelines for Point-of-Care TestingPrinciples of the Hybrid LaboratoryPrinciples of Anticoagulation and Sample TransportScientific Principles of Point-of-Care Whole-Blood AnalysisDry Reagent Prothrombin Time and Other Hemostasis MethodsImmunoassays for Point-of-Care TestingAdvantages and Disadvantages of Point-of-Care Instruments PART II. POINT-OF-CARE TESTING IN THE HOSPITAL AND CLINICAL PRACTICEPoint-of-Care Hematology, Hemostasis, and Thrombolysis TestingPoint-of-Care Testing in Surgery, Intensive Care, and Cardiopulmonary ResuscitationPoint-of-Care Testing in Emergency MedicineOn-Site Evaluation of Chest Pain Using Biochemical Markers of Myocardial InjuryBedside Testing, Glucose Monitoring, and Diabetes ManagementNursing Strategies for Point-of-Care TestingPoint-of-Care Testing for Infectious DiseasesMolecular Diagnosis at the Point of CarePoint-of-Care Drug TestingPoint-of-Care Testing for Body FluidsEx Vivo and In Vivo Monitoring of Prematures and NeonatesPoint-of-Care Testing in the Children's Hospital PART III. POINT-OF-CARE TESTING IN THE HEALTH SYSTEM, COMMUNITY, AND FIELDPoint-of-Care Testing in Primary Care Networks and Managed CarePoint-of-Care testing in the Veteran's Affairs SystemPoint-of-Care Testing in the Community Health SystemPatient Self-Testing and Self-Management of Oral Anticoagulation with Point-of-Care TestingHome-Based Point-of-Care TestingAdvances in the Physician Office Laboratory PART IV. MANAGEMENT, PERFORMANCE, ACCREDITATION, AND EDUCATIONAssessing Point-of-Care Testing ProgramsQuality Management and Administration of Point-of-Care ProgramsRegulation, Accreditation, and EducationMeeting JCAHO Standards for the Hospital SettingPoint-of-Care Testing and the American College of PathologistsFDA Regulation of Home-Use In Vitro Diagnostic DevicesRegulatory Qualification of New Point-of-Care Diagnostic Devices PART V. INFORMATION, SECURITY, AND KNOWLEDGE SYSTEMSInformatics and Data ManagementInformation Systems for Point-of-Care Testing in Critical CareSecurity, Validation, and ConnectivityThe Role of the Clinical Data Repository in Point-of-Care TestingElectronic Consultation and TelemedicineInternet-Based Disease Management for Home Care and Self-Testing PART VI. ECONOMICS, OUTCOME, AND OPTIMIZATIONBilling for Point-of-Care TestingThe Role of Point-of-Care Testing in Care PathsHealth and Disease Management: The Role of Point-of-Care TestingImproving Economic Outcomes by Algorithmic Diagnosis of Myocardial InfarctionUsing Lactate to Predict Patient OutcomesImproving Medical and Economic Outcomes with Point-of-Care Testing INDE
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