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  • 1
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    Calcitonin measurement in pediatrics: reference ranges are gender-dependent, validation in medullary thyroid cancer and thyroid diseases
    Walter de Gruyter GmbH ; 2019
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 57, No. 8 ( 2019-07-26), p. 1242-1250
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 57, No. 8 ( 2019-07-26), p. 1242-1250
    Abstract: There is only limited information on serum reference ranges of calcitonin (CT) in infants, children and adolescents. This gap hampers valid diagnostics in patients with multiple endocrine neoplasia type 2 (MEN 2) and planned prophylactic thyroidectomy. In addition, age-dependent reference ranges for CT are necessary to define a cure in medullary thyroid carcinoma (MTC). We asked whether the reference ranges for CT levels were age- and gender-dependent in the serum of a pediatric cohort. Methods A total of 6090 serum samples of 2639 subjects of the LIFE-Child cohort aged between 1 month and 17.9 years were analyzed by the CT electrochemiluminescence immunoassay (ECLIA). Reference intervals were estimated using the LMS method. For clinical validation the serum of 28 patients (61 samples) with MEN 2 and 106 patients (136 samples) with thyroid diseases were analyzed. Results CT levels showed a clear age- and gender-dependence with significantly higher values in boys (p 〈 0.01). An accelerated decline of CT levels from newborn to children at the age of 4 and 5 years was observed for both sexes. A cure for MTC was demonstrated in 71% of MEN 2 patients after thyroidectomy, whereas 5 patients remained suspicious for micrometastasis or relapse. Only 1.5% of our patients with thyroid diseases revealed increased CT levels. Conclusions This is the largest study to establish novel pediatric reference ranges from the CT values of healthy subjects. It allows a precise laboratory monitoring of CT in pediatric patients with MEN 2. Thyroid diseases did not have a relevant influence on CT levels in our pediatric cohort.
    Type of Medium: Online Resource
    ISSN: 1437-4331 , 1434-6621
    URL: Article
    DOI: 10.1515/cclm-2018-1186
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2019
    detail.hit.zdb_id: 1492732-9
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  • 2
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    Higher troponin T serum concentrations in hospital patients without diagnosed cardiac diseases compared to a population-based cohort
    Walter de Gruyter GmbH ; 2023
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 61, No. 11 ( 2023-10-26), p. 2046-2052
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 61, No. 11 ( 2023-10-26), p. 2046-2052
    Abstract: Upper reference limits of high-sensitivity cardiac troponin T (hs-cTnT) are derived from healthy, population-based cohorts, and are frequently exceeded in hospitalized patients. In this study we aim to systematically examine the differences between in-hospital patients with no diagnosed cardiac diseases and a population-based cohort. Methods Retrospective analyses were performed in two independent cohorts. We included 5,652 participants of the prospective population-based LIFE cohort as well as 9,300 patients having been treated at our hospital between 2014 and 2021. In both cohorts, subjects with diagnosed or suspected cardiac diseases were excluded. We used Spearman’s rank correlation for correlation analyses of hs-cTnT serum concentrations and age. Sex- and age-adjusted 99th percentiles for hs-cTnT in subjects with preserved renal function were obtained in both cohorts. Results In both cohorts, hs-cTnT serum concentrations positively correlated with age. Male sex was associated with higher hs-cTnT serum concentrations. Persons treated in hospital showed significantly higher hs-cTnT concentrations in females and males aged above 50. While in the population-based cohort only 99th percentile hs-cTnT results of females aged above 70 and males aged above 60 years exceeded the assay’s upper reference limit, the 99th percentiles of in-hospital females over 40 years and males of all age groups exceeded this threshold. Conclusions Besides age and sex, hospitalization per se is correlated with higher serum concentrations of hs-cTnT in most age groups. Our results indicate, that unconditionally applying current hs-cTnT cut-offs to inpatients might overestimate myocardial infarction and potentially lead to overdiagnosis.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2023-0040
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2023
    detail.hit.zdb_id: 1492732-9
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  • 3
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    The Clinical Decision Support System AMPEL for Laboratory Diagnostics: Implementation and Technical Evaluation
    JMIR Publications Inc. ; 2021
    In:  JMIR Medical Informatics Vol. 9, No. 6 ( 2021-6-3), p. e20407-
    Details
    In: JMIR Medical Informatics, JMIR Publications Inc., Vol. 9, No. 6 ( 2021-6-3), p. e20407-
    Abstract: Laboratory results are of central importance for clinical decision making. The time span between availability and review of results by clinicians is crucial to patient care. Clinical decision support systems (CDSS) are computational tools that can identify critical values automatically and help decrease treatment delay. Objective With this work, we aimed to implement and evaluate a CDSS that supports health care professionals and improves patient safety. In addition to our experiences, we also describe its main components in a general manner to make it applicable to a wide range of medical institutions and to empower colleagues to implement a similar system in their facilities. Methods Technical requirements must be taken into account before implementing a CDSS that performs laboratory diagnostics (labCDSS). These can be planned within the functional components of a reactive software agent, a computational framework for such a CDSS. Results We present AMPEL (Analysis and Reporting System for the Improvement of Patient Safety through Real-Time Integration of Laboratory Findings), a labCDSS that notifies health care professionals if a life-threatening medical condition is detected. We developed and implemented AMPEL at a university hospital and regional hospitals in Germany (University of Leipzig Medical Center and the Muldental Clinics in Grimma and Wurzen). It currently runs 5 different algorithms in parallel: hypokalemia, hypercalcemia, hyponatremia, hyperlactatemia, and acute kidney injury. Conclusions AMPEL enables continuous surveillance of patients. The system is constantly being evaluated and extended and has the capacity for many more algorithms. We hope to encourage colleagues from other institutions to design and implement similar CDSS using the theory, specifications, and experiences described in this work.
    Type of Medium: Online Resource
    ISSN: 2291-9694
    URL: Article
    DOI: 10.2196/20407
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2021
    detail.hit.zdb_id: 2798261-0
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  • 4
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    Challenge in hyponatremic patients – the potential of a laboratory-based decision support system for hyponatremia to improve patient’s safety
    Walter de Gruyter GmbH ; 2023
    In:  Clinical Chemistry and Laboratory Medicine (CCLM) Vol. 61, No. 6 ( 2023-05-25), p. 1025-1034
    Details
    In: Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 61, No. 6 ( 2023-05-25), p. 1025-1034
    Abstract: Hyponatremia is the most frequent electrolyte disorder in hospitalized patients with increased mortality and morbidity. In this study, we evaluated the follow-up diagnostic, the risk of inadequate fast correction and the outcome of patients with profound hyponatremia (pHN), defined as a blood sodium concentration below 120 mmol/L. The aim was to identify a promising approach for a laboratory-based clinical decision support system (CDSS). Methods This retrospective study included 378,980 blood sodium measurements of 83,315 cases at a German tertiary care hospital. Hospitalized cases with pHN (n=211) were categorized into two groups by the time needed for a follow-up measurement to be performed (time to control, TTC) as either 〈 12 h (group 1: “TTC≤12 h”, n=118 cases) or 〉 12 h (group 2: “TTC 〉 12 h”, n=93 cases). Length of hospital stay, sodium level at discharge, ward transfers, correction of hyponatremia, and risk of osmotic demyelination syndrome (ODS) due to inadequate fast correction were evaluated with regard to the TTC of sodium blood concentration. Results pHN was detected in 1,050 measurements (0.3%) in 211 cases. Cases, in which follow-up diagnostics took longer (TTC 〉 12 h), achieved a significantly lower sodium correction during their hospitalization (11.2 vs. 16.7 mmol/L, p 〈 0.001), were discharged more frequently in hyponatremic states ( 〈 135 mmol/L; 58 (62.4%) vs. 43 (36.4%), p 〈 0.001) and at lower sodium blood levels (131.2 vs. 135.0 mmol/L, p 〈 0.001). Furthermore, for these patients there was a trend toward an increased length of hospital stay (13.1 vs. 8.5 days, p=0.089), as well as an increased risk of inadequate fast correction (p 〈 0.001). Conclusions Our study shows that less frequent follow-up sodium measurements in pHN are associated with worse outcomes. Patients with a prolonged TTC are at risk of insufficient correction of hyponatremia, reduced sodium values at discharge, and possible overcorrection. Our results suggest that a CDSS that alerts treating physicians when a control time of 〉 12 h is exceeded could improve patient care in the long term. We are initiating a prospective study to investigate the benefits of our self-invented CDSS ( www.ampel.care ) for patients with pHN.
    Type of Medium: Online Resource
    ISSN: 1434-6621 , 1437-4331
    URL: Article
    DOI: 10.1515/cclm-2022-0883
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2023
    detail.hit.zdb_id: 1492732-9
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  • 5
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    Age-Related Association of Calcitonin with Parameters of Anthropometry, Bone and Calcium Metabolism during Childhood
    S. Karger AG ; 2020
    In:  Hormone Research in Paediatrics Vol. 93, No. 6 ( 2020), p. 361-370
    Details
    In: Hormone Research in Paediatrics, S. Karger AG, Vol. 93, No. 6 ( 2020), p. 361-370
    Abstract: 〈 b 〉 〈 i 〉 Introduction: 〈 /i 〉 〈 /b 〉 The thyroid parafollicular hormone calcitonin (CT) shows particularly high blood levels in early childhood, a period of high bone turnover, which decrease with increasing age. Data about the physiological role of CT during infancy, childhood, and adolescence are contradictory or lacking. 〈 b 〉 〈 i 〉 Objective: 〈 /i 〉 〈 /b 〉 We hypothesize that CT demonstrates age-related correlations with parameters of bone growth and turnover as well as with parameters of calcium homeostasis. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 5,410 measurements of anthropometric data and venous blood samples were collected from 2,636 participants of the LIFE Child study, aged 2 months–18 years. Univariate correlations and multiple regression analysis were performed between serum CT and anthropometric indicators (height standard deviation scores [SDS] and BMI-SDS), markers of calcium (Ca) homeostasis (Ca, parathyroid hormone, 25-OH vitamin D, and phosphate [P] ), bone formation (procollagen type 1 N-terminal propeptide [P1NP], osteocalcin), and bone resorption (β-CrossLaps). 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 CT was significantly associated with Ca (β = 0.26, 〈 i 〉 p 〈 /i 〉 & #x3c; 0.05) and P1NP/100 (β = 0.005, 〈 i 〉 p 〈 /i 〉 & #x3c; 0.05) in children aged 2 months–1.1 years. These relations were independent of age and sex and could not be confirmed in children aged 1.1–8 years. Independent of age, sex, puberty, P, and height SDS CT showed a significant positive relation to Ca (β = 0.26; 〈 i 〉 p 〈 /i 〉 & #x3c; 0.001) in children aged 8–18 years. 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 Our findings suggest a unique association between CT and Ca in periods of rapid bone growth and point to a possible involvement of CT in promoting bone formation during the first year of life.
    Type of Medium: Online Resource
    ISSN: 1663-2818 , 1663-2826
    URL: Article
    DOI: 10.1159/000512107
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2020
    detail.hit.zdb_id: 2540224-9
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  • 6
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    Acute kidney injury and its progression in hospitalized patients—Results from a retrospective multicentre cohort study with a digital decision support system
    Public Library of Science (PLoS) ; 2021
    In:  PLOS ONE Vol. 16, No. 7 ( 2021-7-12), p. e0254608-
    Details
    In: PLOS ONE, Public Library of Science (PLoS), Vol. 16, No. 7 ( 2021-7-12), p. e0254608-
    Abstract: In this retrospective multicentric cohort study, we evaluate the potential benefits of a clinical decision support system (CDSS) for the automated detection of Acute kidney injury (AKI). A total of 80,389 cases, hospitalized from 2017 to 2019 at a tertiary care hospital (University of Leipzig Medical Center (ULMC)) and two primary care hospitals (Muldentalkliniken (MTL)) in Germany, were enrolled. AKI was defined and staged according to the Kidney disease: improving global outcomes (KDIGO) guidelines. Clinical and laboratory data was automatically collected from electronic patient records using the frameworks of the CDSS. In our cohort, we found an overall AKI incidence proportion of 12.1%. We identified 6,393/1,703/1,604 cases as AKI stage 1/2/3 (8.0%/2.1%/2.0%, respectively). Administrative coding with N17 (ICD-10-GM) was missing in 55.8% of all AKI cases with the potential for additional diagnosis related groups (DRG) reimbursement of 1,204,200 € in our study. AKI was associated with higher hospital mortality, increased length of hospitalisation and more frequent need of renal replacement therapy. A total of 19.1% of AKI cases (n = 1,848) showed progression to higher AKI stages (progressive AKI) during hospitalization. These cases presented with considerably longer hospitalization, higher rates of renal replacement therapy and increased mortality (p 〈 0.001, respectively). Furthermore, progressive AKI was significantly associated with sepsis, shock, liver cirrhosis, myocardial infarction, and cardiac insufficiency. AKI, and especially its progression during hospitalization, is strongly associated with adverse outcomes. Our automated CDSS enables timely detection and bears potential to improve AKI outcomes, notably in cases of progressive AKI.
    Type of Medium: Online Resource
    ISSN: 1932-6203
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    DOI: 10.1371/journal.pone.0254608
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    Language: English
    Publisher: Public Library of Science (PLoS)
    Publication Date: 2021
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  • 7
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    Development, Design and Utilization of a CDSS for Refeeding Syndrome in Real Life Inpatient Care—A Feasibility Study
    MDPI AG ; 2023
    In:  Nutrients Vol. 15, No. 17 ( 2023-08-24), p. 3712-
    Details
    In: Nutrients, MDPI AG, Vol. 15, No. 17 ( 2023-08-24), p. 3712-
    Abstract: Background: The refeeding syndrome (RFS) is an oftentimes-unrecognized complication of reintroducing nutrition in malnourished patients that can lead to fatal cardiovascular failure. We hypothesized that a clinical decision support system (CDSS) can improve RFS recognition and management. Methods: We developed an algorithm from current diagnostic criteria for RFS detection, tested the algorithm on a retrospective dataset and combined the final algorithm with therapy and referral recommendations in a knowledge-based CDSS. The CDSS integration into clinical practice was prospectively investigated for six months. Results: The utilization of the RFS-CDSS lead to RFS diagnosis in 13 out of 21 detected cases (62%). It improved patient-related care and documentation, e.g., RFS-specific coding (E87.7), increased from once coded in 30 month in the retrospective cohort to four times in six months in the prospective cohort and doubled the rate of nutrition referrals in true positive patients (retrospective referrals in true positive patients 33% vs. prospective referrals in true positive patients 71%). Conclusion: CDSS-facilitated RFS diagnosis is possible and improves RFS recognition. This effect and its impact on patient-related outcomes needs to be further investigated in a large randomized-controlled trial.
    Type of Medium: Online Resource
    ISSN: 2072-6643
    URL: Article
    DOI: 10.3390/nu15173712
    Language: English
    Publisher: MDPI AG
    Publication Date: 2023
    detail.hit.zdb_id: 2518386-2
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  • 8
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    Calcitonin and complementary biomarkers in the diagnosis of hereditary medullary thyroid carcinoma in children and adolescents
    Walter de Gruyter GmbH ; 2021
    In:  Journal of Pediatric Endocrinology and Metabolism Vol. 34, No. 12 ( 2021-12-20), p. 1491-1504
    Details
    In: Journal of Pediatric Endocrinology and Metabolism, Walter de Gruyter GmbH, Vol. 34, No. 12 ( 2021-12-20), p. 1491-1504
    Abstract: Medullary thyroid carcinoma (MTC) is a rare malignancy that is effectively curable by surgery. Unlike in adults, hereditary MTC has a predominant role in children. A fast and safe diagnosis is important to assure the good prognosis for the patients. A major cornerstone is the assessment of biomarkers, but the interpretation must respect their pre-, post- and analytical features. Especially calcitonin (Ctn) is a challenging biomarker in daily laboratory diagnostics. However, Ctn is of particular relevance for the diagnostic in MTC. The American Thyroid Association recommends thyroidectomy if the upper reference range of Ctn is exceeded. Interestingly, age-dependent reference ranges for children and adolescents have become available only recently for Ctn assays. With this review, we aim to highlight the importance of a timely diagnosis of MTC in children and adolescents. Content Recent developments in pediatric biochemical diagnostics of MTC were summarized. This includes guidance on interpretation of RET , Ctn, procalcitonin, carcinoembryonic antigen, carbohydrate antigen 19-9, and chromogranin A. Summary Currently, Ctn is the most investigated biomarker in the diagnosis of MTC in children and adolescents. Other biomarkers as PCT suggest complementary evidence about pediatric MTC but their interpretation based largely on adult’s data. A successful treatment of MTC requires, besides results of biomarkers, information about medical history, RET gene analysis and recent guideline knowledge. Outlook More research is required to validate complementary biomarkers of Ctn in children. Additionally, the effect of different confounder on pediatric Ctn levels has to be further clarified.
    Type of Medium: Online Resource
    ISSN: 0334-018X , 2191-0251
    URL: Article
    DOI: 10.1515/jpem-2021-0163
    Language: English
    Publisher: Walter de Gruyter GmbH
    Publication Date: 2021
    detail.hit.zdb_id: 2583847-7
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