Chancen und Risiken von e-Health in der Labormedizin

Orth, Matthias; Aufenanger, Johannes; Hoffmann, Georg; Lichtinghagen, Ralf; Stiegler, Yuriko; Peetz, D.; Gese, für die Sektion Labormanagement der Deutschen Vereinten

doi:10.1515/labmed-2016-0040

Cited by 4 publications

(2 citation statements)

References 49 publications

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“…As digitalization of medicine increases, so does the need for standardized laboratory results for long-term storage in electronic health and patient files [1]. At its core, it is mainly about the medical interpretability of quantitative measured results against the background of analytical and biological variability -and all that in the most diverse context possible: from the one-time intake status in an emergency room to the long-term monitoring of the chronically ill, as well as from simple lifestyle counseling at the gym to assessing the critical situation of an intensive-care patient.…”

Section: Introductionmentioning

confidence: 99%

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The zlog value as a basis for the standardization of laboratory results

Hoffmann¹,

Klawonn

Lichtinghagen

et al. 2017

LaboratoriumsMedizin

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Background:With regard to the German E-Health Law of 2016, the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) has been invited to develop a standard procedure for the storage and transmission of laboratory results. We suggest the commonly used z-transformation.Methods:This method evaluates by how many standard deviations (SDs) a given result deviates from the mean of the respective reference population. We confirm with real data that laboratory results of healthy individuals can be adjusted to a normal distribution by logarithmic transformation.Results:Thus, knowing the lower and upper reference limits LL and UL, one can transform any result x into a zlog value using the following equation:$\eqalign{ {\rm{zlog}} = & {\rm{(log(x)}}-{\rm{(log(LL)}} + {\rm{log(UL))/2)\cdot3}}{\rm{.92/(log(UL)}} \cr -{\bf{ }}{\rm{log(LL))}} \cr} $The result can easily be interpreted, as its reference interval (RI) is –1.96 to +1.96 by default, and very low or high results yield zlog values around –5 and +5, respectively. For intuitive data presentation, the zlog values may be transformed into a continuous color scale, e.g. from blue via white to orange.Using the inverse function, any zlog value can then be translated into the theoretical result of an analytical method with another RI:(1)$${\rm{x}} = {\rm{L}}{{\rm{L}}^{0.5 - {\rm{zlog}}/3.92}} \cdot {\rm{U}}{{\rm{L}}^{0.5 + {\rm{zlog}}/3.92}}$$Conclusions:Our standardization proposal can easily be put into practice and may effectively contribute to data quality and patient safety in the frame of the German E-health law. We suggest for the future that laboratories should provide the zlog value in addition to the original result, and that the data transmission protocols (e.g. HL7, LDT) should contain a special field for this additional value.

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Section: Introductionmentioning

confidence: 99%

“…It is submitted in support of standardized electronic storage and communication of laboratory results regardless of the methodology and unit employed in the respective case. The proposal is based on published work done by various working groups of the DGKL [1,9,[12][13][14][15].…”

Section: Introductionmentioning

confidence: 99%

The zlog value as a basis for the standardization of laboratory results

Hoffmann¹,

Klawonn

Lichtinghagen

et al. 2017

LaboratoriumsMedizin

Self Cite

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Direct-to-consumer laboratory testing (DTCT): challenges and implications for specialists in laboratory medicine

Orth

Vollebregt²,

Trenti

et al. 2022

Clinical Chemistry and Laboratory Medicine (CCLM)

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In vitro diagnostics (IVD) testing is a powerful tool for medical diagnosis, and patients‘ safety is guaranteed by a complex system of personnel qualification of the specialist in laboratory medicine, of process control, and legal restrictions in healthcare, most of them under national regulation. Direct-to-consumer laboratory testing (DTCT) is testing ordered by the consumer and performed either by the consumer at home or analysis of self-collected samples in a laboratory. However, since DTCT are not always subject to effective competent authority oversight, DTCT may pose risks to lay persons using and relying on it for healthcare decision-making. Laboratory medicine specialists should be very cautious when new DTCTs are introduced. As qualified professionals, they should feel obliged to warn and educate patients and the public about the risks of inappropriate and harmful DTCT.

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Der zlog-Wert als Basis für die Standardisierung von Laborwerten

Hoffmann¹,

Klawonn

Lichtinghagen

et al. 2017

LaboratoriumsMedizin

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ZusammenfassungHintergrundIm Zuge des deutschen E-Health-Gesetzes von 2016 wurde die DGKL aufgefordert, Vorschläge für die standardisierte Speicherung und Übermittlung von Labordaten zu erarbeiten. Wir schlagen dafür die in der Statistik weit verbreitete z-Transformation vor.MethodenMan erhält mit diesem Verfahren einen Relativwert, der angibt, um wie viele Standardabweichungen ein Messwert vom Mittelwert des Referenzkollektivs abweicht. Anhand realer Daten belegen wir die Annahme, dass die Werte gesunder Referenzpersonen durch logarithmische Transformation einer Normalverteilung angenähert werden können.ErgebnisseKennt man somit die Unter- und Obergrenze UG und OG des Referenzintervalls, so kann man jedes Laborergebnis mit folgender Gleichung transformieren:$\eqalign{ & {\rm{zlog}} = {\rm{(log(x)}}-{\bf{ }}{\rm{(log(UG)}} + {\rm{log(OG))/2)}} \cdot {\rm{3,92/(log(OG)}} \cr & & -{\bf{ }}{\rm{log(UG))}} \cr} $Der zlog-Wert ist leicht interpretierbar: Sein Referenzintervall liegt methodenunabhängig stets zwischen –1,96 und +1,96; stark erniedrigte oder erhöhte Laborergebnisse führen zu zlog-Werten um –5 bzw. +5. Für eine intuitive Befunddarstellung kann man zlog-Werte auch in eine kontinuierliche Farbskala, z. B. von Blau über Weiß bis Orange umrechnen.Mithilfe der Umkehrfunktion lässt sich aus dem zlog-Wert auch das theoretische Resultat einer Messmethode mit einem anderen Referenzintervall berechnen:${\rm{x}} = {\rm{U}}{{\rm{G}}^{0,5{\bf{ }} - {\bf{ }}{\rm{zlog}}/3,92}} \cdot {\rm{O}}{{\rm{G}}^{0,5{\bf{ }} + {\bf{ }}{\rm{zlog}}/3,92}}$SchlussfolgerungUnser Standardisierungsvorschlag ist ein leicht realisierbarer und effektiver Beitrag zur Verbesserung der Datenqualität und Patientensicherheit im Rahmen des E-Health-Gesetzes. Es wird gefordert, dass alle Labore künftig zusätzlich zum Originalwert den zlog-Wert zur Verfügung stellen und dass in die Protokolle für die elektronische Labordatenübertragung (HL7, LDT) ein eigenes Feld für diesen zusätzlichen Wert eingefügt wird.

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Chancen und Risiken von e-Health in der Labormedizin

Cited by 4 publications

References 49 publications

The zlog value as a basis for the standardization of laboratory results

The zlog value as a basis for the standardization of laboratory results

Direct-to-consumer laboratory testing (DTCT): challenges and implications for specialists in laboratory medicine

Der zlog-Wert als Basis für die Standardisierung von Laborwerten

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