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The choice of study designs of diagnostic accuracy using Borrelia specific IgG and IgM antibodies for the diagnosis of Lyme borreliosis
Ram Benny Dessau, Alice Raffetin, Randi Eikeland, Volker Fingerle, Anna J. Henningsson, Klaus-Peter Hunfeld, Benoit Jaulhac, Reto Lienhard, Per-Eric Lindgren, Franc Strle, 2025, review article

Abstract: Background: Laboratory diagnosis of Lyme borreliosis (LB) is used in a variety of clinical settings where a range of other diagnoses may be considered. Therefore, it is essential that diagnostic accuracy studies and literature reviews consider information from different types of studies and choices of sample groups. The quality of patient selection is important to minimize the risk of misclassification. This narrative review was inspired by systematic reviews where nearly all studies on the diagnostic accuracy for LB tests were determined as biased and having low quality based solely on study design considerationsdnot the clinical relevance. Objectives: To propose flexible design and interpretation of studies used to assess diagnostic accuracy in clinical microbiology. Sources: Criteria for rating the quality of studies were discussed among the ESCMID study group for LB ESGBOR (The ESCMID study group for Lyme borreliosis). The literature was searched for similar methodological discussions. Content: Knowledge of antibody reactivity in the background population across various clinical patient groups with and without infection should consider variations in clinical presentation and duration of disease. Case-control studies are the most frequently used design and were judged particularly instrumental in assessing serologic testing. However, clinical and epidemiological studies not specifically intended for diagnostic accuracy may also contribute estimates of sensitivity and specificity. Systematic reviews should focus on the application of the diagnostic assay for the individual patient in various clinical settings, rather than seeking an unbiased average. Different LB sample groups and controls for test panels are discussed. Implications: Case-control (two-gate design) studies, case series, and seroprevalence studies representing the range of LB in different populations are necessary to assess the diagnostic accuracy of serological tests for LB. A broader range of studies should be considered for inclusion in systematic reviews of diagnostic accuracy
Keywords: case-control design, cross-sectional design, diagnostic accuracy, diagnostic antibody tests, diagnostic test accuracy, Lyme borreliosis, research design, serology, systematic review
Published in DiRROS: 09.03.2026; Views: 411; Downloads: 326
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2.
European society of clinical microbiology and infectious diseases guidelines for antimicrobial stewardship in emergency departments (endorsed by European association of hospital pharmacists)
Teske Schoffelen, Cihan Papan, Elena Carrara, Khalid Eljaaly, Paul Mical, Emma Keuleyan, Alejandro Martin Quirós, Nathan Peiffer-Smadja, Bojana Beović, 2024, review article

Abstract: Scope: This European Society of Clinical Microbiology and Infectious Diseases guideline provides evidence-based recommendations to support a selection of appropriate antibiotic use practices for patients seen in the emergency department (ED) and guidance for their implementation. The topics addressed in this guideline are (a) Do biomarkers or rapid pathogen tests improve antibiotic prescribing and/or clinical outcomes? (b) Does taking blood cultures in common infectious syndromes improve antibiotic prescribing and/or clinical outcomes? (c) Does watchful waiting without antibacterial therapy or with delayed antibiotic prescribing reduce antibiotic prescribing without worsening clinical outcomes in patients with specific infectious syndromes? (d) Do structured culture follow-up programs in patients discharged from the ED with cultures pending improve antibiotic prescribing? Methods: An expert panel was convened by European Society of Clinical Microbiology and Infectious Diseases and the guideline chair. The panel selected in consensus the four most relevant antimicrobial stewardship topics according to pre-defined relevance criteria. For each main question for the four topics, a systematic review was performed, including randomized controlled trials and observational studies. Both clinical outcomes and stewardship process outcomes related to antibiotic use were deemed relevant. The literature searches were conducted between May 2021 and March 2022. In April 2022, the panel members were formally asked to suggest additional studies that were not identified in the initial searches. Data were summarized in a meta-analysis if possible or otherwise summarized narratively. The certainty of the evidence was classified according to the Grading of Recommendations Assessment, Development and Evaluation criteria. The guideline panel reviewed the evidence per topic critically appraising the evidence and formulated recommendations through a consensus-based process. The strength of the recommendations was classified as strong or weak. To substantiate the implementation process, implementation trials or observational studies describing facilitators/barriers for implementation were identified from the same searches and were summarized narratively. Recommendations: The recommendations on the use of biomarkers and rapid pathogen diagnostic tests focus on the initiation of antibiotics in patients admitted through the ED. Their effect on the discontinuation or de-escalation of antibiotics during hospital stay was not reported, neither was their effect on hospital infection prevention and control practices. The recommendations on watchful waiting (i.e. withholding antibiotics with some form of follow-up) focus on specific infectious syndromes for which the primary care literature was also included. The recommendations on blood cultures focus on the indication in three common infectious syndromes in the ED explicitly excluding patients with sepsis or septic shock. Most recommendations are based on very low and low certainty of evidence, leading to weak recommendations or, when no evidence was available, to best practice statements. Implementation of these recommendations needs to be adapted to the specific settings and circumstances of the ED. The scarcity of high-quality studies in the area of antimicrobial stewardship in the ED highlights the need for future research in this field.
Keywords: antimicrobial stewardship, blood cultures, culture follow-up, diagnostic tests, emergency department, guideline, implementation, rapid tests, recommendations, watchful waiting
Published in DiRROS: 09.03.2026; Views: 506; Downloads: 603
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