Article
Dipsticks and point-of-care Microscopy to reduce antibiotic use in women with an uncomplicated Urinary Tract Infection (MicUTI): randomised controlled pilot trial in primary care – preliminary results
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Authors
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Peter K. Kurotschka
- Universitätsklinikum Würzburg, Institut für Allgemeinmedizin, Würzburg, Deutschland
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Gábor Borgulya
- Universitätsklinikum Würzburg, Institut für Allgemeinmedizin, Würzburg, Deutschland
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Eva Bucher
- Universitätsklinikum Würzburg, Institut für Allgemeinmedizin, Würzburg, Deutschland
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Adolfo Figueiras
- University of Santiago de Compostela, Department of Preventive Medicine and Public Health, Santiago de Compostela, Spanien
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Jochen Gensichen
- Klinikum der Universität München, LMU München, Institut für Allgemeinmedizin, München, Deutschland
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Alastair D. Hay
- University of Bristol, Centre for Academic Primary Care, Bristol Medical School: Population Health Sciences, Department of Community Based Medicine, Bristol, Großbritannien
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Alexander Hapfelmeier
- Technische Universität München, Institut für Allgemeinmedizin, Institute of AI and Informatics in Medicine, München, Deutschland
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Christian Kretzschmann
- Universitätsklinikum Würzburg, Institut für Allgemeinmedizin, Würzburg, Deutschland
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Oliver Kurzai
- Universität Würzburg, Institut für Hygiene und Mikrobiologie, Würzburg, Deutschland
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Thien-Tri Lam
- Universität Würzburg, Institut für Hygiene und Mikrobiologie, Würzburg, Deutschland
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Kathrin Lasher
- Universitätsklinikum Würzburg, Institut für Allgemeinmedizin, Würzburg, Deutschland
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Orietta Massidda
- University of Trento, Department of Cellular, Computational and Integrative Biology, Interdepartmental Center of Medical Sciences (CISMed), Trento, Italien
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Linda Sanftenberg
- Klinikum der Universität München, LMU München, Institut für Allgemeinmedizin, München, Deutschland
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Guido Schmiemann
- Universität Bremen, Institute of Public Health and Nursing Research (IPP), Bremen, Deutschland
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Antonius Schneider
- Technische Universität München, Institut für Allgemeinmedizin, München, Deutschland
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Anne Simmenroth
- Universitätsklinikum Würzburg, Institut für Allgemeinmedizin, Würzburg, Deutschland
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Stefanie Stark
- Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
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Lisette Warkentin
- Universitätsklinikum Erlangen, Allgemeinmedizinisches Institut, Erlangen, Deutschland
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Mark H Ebell
- University of Georgia, Department of Epidemiology and Biostatistics, USA
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Ildikó Gágyor
- Universitätsklinikum Würzburg, Institut für Allgemeinmedizin, Würzburg, Deutschland
| Published: | September 23, 2024 |
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Outline
Text
Background: Rapid point-of-care tests (POCTs) to detect erythrocytes and bacteria in urine may help general practitioners to identify women with acute cystitis in whom non-antibiotic treatments could be adopted safely.
Research question: Is a primary care cluster randomized controlled trial (RCT) on a POCT based management to detect erythrocytes and bacteria in urine feasible?
Methods: Two-arm parallel 1:1 cluster RCT. 20 general practices of the Bavarian Practice-Based Research Network were randomly assigned to deliver patient management based on phase-contrast microscopy and dipsticks or to provide usual care. Urine samples were obtained for POCTs (intervention arm) and microbiological analysis. Women were followed-up for 28 days using symptom diaries, telephone calls and electronic medical record reviews. Primary outcomes were recruitment and retention rates. Data are analyzed via mixed-effects models. At the end of patient enrollment, clinicians were interviewed to gain further insides on feasibility. Notes are analyzed via qualitative content analysis.
Results: 154 patients were recruited across 20 general practices over 8 months. The median number of recruited patients per site was 7 (IQR 4–11). Of those, 137 (88%) had a complete follow-up. Clinicians described the restrictive inclusion/exclusion criteria as hampering the recruitment process. Further results will be presented at the congress (analyses in progress).
Discussion: The intervention and the trial procedures were proven feasible. However, cluster size varied (range 1–15), so that a confirmatory cluster RCT would probably need a sample size too big to be efficient. In the context of German primary care, an individual RCT should be the preferred study design whenever outcomes are measured at the individual level. If this is not feasible due to contamination, cross-over or stepped-wedge cluster RCT designs may be alternative, more efficient, options.
Take Home Message for the practice: Phase-contrast microscopy was seen as a useful and rapid tool to detect bacteria in urine and may help physicians in counseling women with uUTI.
