Project

AMPEL CDSS

Goal: Background
Laboratory diagnostics are essential for diagnosis, initiation of therapy, and monitoring of patients. Laboratory results that are overlooked or incorrectly interpreted lead to adverse events and endanger patient safety. Clinical decision support systems (CDSSs) may facilitate appropriate interpretation of results and subsequent medical response.

Objectives
The research project on digital laboratory medicine (AMPEL) aims at developing a CDSS based on laboratory diagnostics, which supports practitioners in ensuring the necessary medical consequences.

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Project log

Maria Schmidt
added a research item
Acute kidney injury (AKI) is a common disease, with high morbidity and mortality rates. In this study, we investigated the potential influence of sex and age on laboratory diagnostics and outcomes. It is known that serum creatinine (SCr) has limitations as a laboratory diagnostic parameter for AKI due to its dependence on muscle mass, which may lead to an incorrect or delayed diagnosis for certain patient groups, such as women and the elderly. Overall, 7592 cases with AKI, hospitalized at the University of Leipzig Medical Center (ULMC) between 1st January 2017 and 31st December 2019, were retrospectively analyzed. The diagnosis and staging of AKI were performed according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, based on the level and dynamics of SCr. The impact of sex and age was analyzed by the recalculation of a female to male and an old to young SCr using the CKD-EPI equation. In our study cohort progressive AKI occurred in 19.2% of all cases (n = 1458). Female cases with AKI were underrepresented (40.4%), with a significantly lower first (−3.5 mL/min) and last eGFR (−2.7 mL/min) (p < 0.001). The highest incidence proportion of AKI was found in the [61–81) age group in female (49.5%) and male (52.7%) cases. Females with progressive AKI were underrepresented (p = 0.04). By defining and staging AKI on the basis of relative and absolute changes in the SCr level, it is more difficult for patients with low muscle mass and, thus, a lower baseline SCr to be diagnosed by an absolute SCr increase. AKIN1 and AKIN3 can be diagnosed by a relative or absolute change in SCr. In females, both stages were less frequently detected by an absolute criterion alone (AKIN1 ♀ 20.2%, ♂ 29.5%, p < 0.001; AKIN3 ♀ 13.4%, ♂ 15.2%, p < 0.001). A recalculated SCr for females (as males) and males (as young males) displayed the expected increase in AKI occurrence and severity with age and, in general, in females. Our study illustrates how SCr, as the sole parameter for the diagnosis and staging of AKI, bears the risk of underdiagnosis of patient groups with low muscle mass, such as women and the elderly. A sex- and age-adapted approach might offer advantages.
Maria Schmidt
added a research item
Objectives 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.
Felix Eckelt
added a research item
Background Laboratory diagnostics are essential for diagnosis, initiation of therapy, and monitoring of patients. Laboratory results that are overlooked or incorrectly interpreted lead to adverse events and endanger patient safety. Clinical decision support systems (CDSSs) may facilitate appropriate interpretation of results and subsequent medical response.Objectives The research project on digital laboratory medicine (AMPEL) aims at developing a CDSS based on laboratory diagnostics, which supports practitioners in ensuring the necessary medical consequences.Materials and methodsA literature review of CDSSs describes the current state of research. The research project AMPEL is presented with its objectives, challenges, and first results. Furthermore, the development of a framework and reporting system is illustrated through the clinical example of severe hypokalemia.Results and conclusionThrough interdisciplinary development and constant optimization, a specific CDSS with high acceptance among clinicians was developed. Initial results in the case of severe hypokalemia show a positive effect on patient care. Thereby, more complex frameworks such as sepsis diagnostics or acute coronary syndrome are implemented. The limited availability of standardized and digital clinical data is challenging. In addition to the application of classic decision trees in CDSS, the use of machine learning offers a promising perspective for future developments.
Daniel Steinbach
added a research item
Preprint of the development and external validation of an machine learning model to predict sepsis with ICU admission based only on complete blood counts. The results demonstrate that routine CBC results could significantly improve diagnosis of sepsis when combined with machine learning. The CBC model can facilitate early sepsis prediction in non-ICU patients with high robustness in external validations. Its implementation in clinical decision support systems has strong potential to provide an essential time advantage and increase patient safety.
Maria Schmidt
added a research item
Zusammenfassung In der Gesamtnovelle der Querschnittsleitlinie (QLL) Hämotherapie der Bundesärztekammer (BÄK) 2020 wurde der Hämoglobin-Transfusionstrigger (Hb-Transfusionstrigger) bei akutem Blutverlust ohne zusätzliche Risikofaktoren aufgrund einer Neubewertung der internationalen Evidenz von 3,7 mmol/l (6 g/dl) auf 4,3 mmol/l (7 g/dl) angepasst. Ziel der vorliegenden Studie ist die retrospektive Analyse des Transfusionsverhaltens von EK bezüglich der Maßgaben der QLL. Zu diesem Zweck analysierten wir individuelle Prä- und Posttransfusions-Hb-Werte von Erythrozytenkonzentraten (EK), die im 4. Quartal 2019 (4946 EKs, 129 560 Hb-Werte) und 2020 (5502 EKs, 134 404 Hb-Werte) am Universitätsklinikum Leipzig (UKL) transfundiert wurden. Der mediane Hb-Wert vor der Transfusion betrug 4,3 mmol/l (7 g/dl) (680 medizinische Fälle, die 2724 EK in 1801 Transfusionen im Jahr 2019 erhielten). Von allen Transfusionen im Jahr 2019 zeigten 899 (49,9%) Transfusionen Hb-Werte < 4,3 mmol/l (7 g/dl) vor der Transfusion, während 152 (8,4%) Hb-Werte < 3,7 mmol/l (6 g/dl) aufwiesen. 2020 wurden jeweils vergleichbare Ergebnisse ermittelt. Wir zeigen, dass der mediane Hb-Anstieg nach der Transfusion eines EK 0,6 mmol/l (1 g/dl) betrug. 34,7% aller Transfusionen erreichten den erwarteten Anstieg von 0,6 mmol/l (1 g/dl) pro EK. Der absolute Anstieg nahm bei Transfusionen mit mehreren EK im Vergleich zu Transfusionen mit einem EK nicht linear zu. Der Grad der Hb-Erhöhung korrelierte invers mit dem Hb-Wert vor Transfusion. Der Hb-Wert nach der Transfusion wurde bei 96,3% der Fälle innerhalb von 24 Stunden nach Hämotherapie kontrolliert. Zusammenfassend spiegelt das Transfusionsverhalten generell die Empfehlungen der Leitlinie. Um ein optimiertes, individualisiertes und dennoch restriktives Transfusionsverhalten bei EK zu erreichen, schlagen wir die Implementierung eines klinischen Entscheidungsunterstützungssystems (CDSS) bei Verschreibung jeder einzelnen EK-Transfusion vor, welches Ärzte bei der Einhaltung der Transfusionsleitlinie unterstützt und über Abweichungen informiert.
Maria Schmidt
added a research item
Objective Acute kidney injury (AKI) is a common disease, with high morbidity and mortality rates. In this study, we investigate the potential influence of sex and age on laboratory diagnostic and outcome. It is known that serum creatinine (SCr) has limitations as a laboratory diagnostic parameter for AKI due to its dependence on muscle mass, which may lead to incorrect or delayed diagnosis for certain patient groups, such as women and the elderly. Methods Overall, 7592 cases with AKI, hospitalized at the University of Leipzig Medical Center (ULMC) between 1 st January 2017 and 31 st December 2019, were retrospectively analyzed. Diagnosis and staging of AKI was performed according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, based on the level and dynamics of SCr. The impact of sex and age was analyzed by the recalculation of a female to male and an old to young SCr using the CKD-EPI equation. Results The incidence proportion of AKI in our study cohort was 12.0%, with progressive AKI occurring in 19.2% of these cases (n = 1458). Male cases with AKI were overrepresented (59.6%), with a significantly higher first (+3.5 ml/min) and last eGFR (+2.7 ml/min) (p < 0.001). The highest incidence proportion of AKI was found in the [61–81) age group in female (49.5%) and male (52.7%) cases. Males with progressive AKI were overrepresented (p = 0.04). By defining and staging AKI on the basis of relative and absolute changes in SCr level, it is more difficult for patients with low muscle mass and thus a lower baseline SCr to be diagnosed by an absolute SCr increase. AKIN1 and AKIN3 can be diagnosed by a relative or absolute change in SCr. In females, both stages were less frequently detected by an absolute criterion alone (AKIN1 ♀ 20.2%, ♂ 29.5%, p < 0.001; AKIN3 ♀ 13.4%, ♂ 15.2%, p < 0.001). A recalculated SCr for females (to males) and males (to young males) displayed the expected increase in AKI occurrence and severity with age and in general in females. Conclusion Our study illustrates how SCr as the sole parameter for diagnosis and staging of AKI bears the risk of underdiagnosis of patient groups with low muscle mass, such as women and the elderly. A sex- and age-adapted approach might offer advantages.
Thorsten Kaiser
added a research item
Diagnosehilfe für akutes Nierenversagen Laborbasierter Alarm erhöht die Patientensicherheit Das akute Nierenversagen ist ein Beispiel dafür, wie wichtig bei der stationären Behandlung das rechtzeitige Erkennen einer Erkrankung ist, die ansonsten das Outcome etwa von Operationen erheblich verschlechtert. Unterstützende Algorithmen bieten sich hierfür als Hilfe an.
Maria Schmidt
added 2 research items
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.
Background 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.
Christiane Gärtner
added a research item
Abstract: (1) Background: Highly sensitive cardiac troponin T (hs-cTnT) plays an essential role in the diagnosis of myocardial injury. The upper reference limit of the respective assay is generally applied, irrespective of age, renal function, or sex. We aimed to identify age-adjusted and sex-adjusted upper reference limits in relation to renal function in a large population-based cohort without cardiac diseases. (2) Methods: We included 5428 subjects of the population-based LIFE-Adult cohort, free of diagnosed cardiac diseases. Sex-adjusted and age-adjusted 99th percentiles for hs-cTnT in subjects with preserved renal function were obtained. (3) Results: The hs-cTnT values were higher in men of all age groups. In both sexes, an increasing age positively correlated with higher hs-cTnT values. Hs-cTnT weakly correlated with serum creatinine. The three-dimensional analysis of age, creatinine, and hs-cTnT showed no relevant additional effect of creatinine on hs-cTnT. In men aged above 60 and women above 70, the calculated 99th percentiles clearly exceeded the commonly applied thresholds. (4) Conclusion: Age and sex have a major impact on the serum concentration of hs-cTnT, while renal function does not. We propose to consider age-adjusted and sex-adjusted reference values.
David Kotzerke
added a project goal
Background
Laboratory diagnostics are essential for diagnosis, initiation of therapy, and monitoring of patients. Laboratory results that are overlooked or incorrectly interpreted lead to adverse events and endanger patient safety. Clinical decision support systems (CDSSs) may facilitate appropriate interpretation of results and subsequent medical response.
Objectives
The research project on digital laboratory medicine (AMPEL) aims at developing a CDSS based on laboratory diagnostics, which supports practitioners in ensuring the necessary medical consequences.