Statistical Bases of Reference Values in Laboratory Medicine

Harris, Eugene K.; Boyd, James C.

doi:10.1201/9781482273151

Cited by 163 publications

(139 citation statements)

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“…In Bezug zu etablierten Referenz-oder Schwellenwerten erfolgt eine Beurteilung der Messergebnisse individueller Studienteilnehmer und eine Zuordnung zu bestimmten Krankheitsoder Risikogruppen. Auf diese Grundlage wiederum stützen sich Einschätzungen zur Prävalenz bestimmter Gesundheitsstörungen oder Erkrankungsrisiken, sodass die Entscheidungskriterien selbst gut validiert und methodisch abgesichert sein müssen [1].…”

Section: Hintergrund Und Fragestellungunclassified

Biochemical measures in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS)¹

Thierfelder

Dortschy

Hintzpeter

et al. 2008

LaboratoriumsMedizin

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In the framework of the German Health Interview and Examination Survey for Children and Adolescents (KiGGS), a series of clinical chemical parameters was determined in order to provide objective information on health status and particular health risks in addition to parent interview data and anthropometric measurements. In total, 43 parameters covered three areas of particular public health interest: nutrient deficiency, sero-epidemiology of past infectious diseases and immunization status, and risk indicators or risk factors for chronic non-communicable diseases. The parameters were classified into five categories: these reflected the availability of reference ranges or cut-off values that are valid for children and young people, and they also depended on the degree of standardization of each test method. The present paper discusses initial descriptive results for selected parameters representing the various categories. In order to assess the public health significance of the results, and perhaps to derive standard reference ranges relevant to health care, more detailed analyses will be required. As a first step, these will focus on cross-sectional analyses of the association between biochemical parameters and other health-related anthropometric and socio-demographic variables. Intermediate and long-term objectives will include the construction of multidimensional reference ranges taking into account several laboratory parameters and additional clinical information, and the prognostic validation of reference ranges or cut-off values for selected parameters based on follow-up of study participants for clinical outcomes.

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Section: Hintergrund Und Fragestellungunclassified

Biochemical measures in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS)¹

Thierfelder

Dortschy

Hintzpeter

et al. 2008

LaboratoriumsMedizin

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“…Estimation of age-related quantiles followed a proposition of Altman 21 (see also the work by Harris and Boyd 22 ). Cubic regression on log scale yielded the median curve y(t).…”

Section: Statistical Analysesmentioning

confidence: 99%

Cardiac Output and Central Distribution of Blood Flow in the Human Fetus

2001

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Background-The objectives of this study were to establish reference ranges for left and right cardiac output and to investigate blood flow distribution through the foramen ovale, ductus arteriosus, and pulmonary bed in human fetuses. Methods and Results-A prospective study was performed in 222 normal fetuses from 13 to 41 weeks of gestation with high-resolution color Doppler ultrasound. Cardiac output and ductal flow were calculated by use of vessel diameter and the time-velocity integral. Pulmonary blood flow was expressed as the difference between right cardiac output and ductal flow. Foramen ovale flow was estimated as the difference between pulmonary flow and left cardiac output. Gestational age-specific reference ranges are given for left, right, and biventricular output and volume of ductal blood flow, showing an exponential increase with gestational age. Median ratio of right to left cardiac output was 1.42 and was not associated with gestational age. Right cardiac output was 59% and left cardiac output was 41% of biventricular cardiac output. Median biventricular cardiac output was estimated to be 425 mL · min Ϫ1 · kg Ϫ1 fetal weight. Ductal blood flow was 46%, estimated pulmonary flow was 11%, and estimated foramen ovale flow was 33% of biventricular output. Conclusions-The study establishes reference ranges for fetal cardiac output and offers insights into the central blood flow distribution in human fetuses from 13 weeks to term. There is a clear right heart dominance. The estimated ratio of pulmonary blood flow to cardiac output is higher than in fetal lamb studies. (Circulation. 2001;103:1662-1668.)

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“…These sets of 'reference' values or their predecessors, 'normal' values, have been used by physicians for generations to assist them in interpreting biochemical or physiological measurements in patients [3,4]. Advanced theory on statistical approaches for the determination of reference values is available in the books by Harris and Boyd [5] and Horn and Pesce [6]. In addition, the Clinical Laboratory Standards Institute and the International Federation of Clinical Chemistry (IFCC) have issued detailed sets of guidelines regarding the determination of reference limits [7][8][9][10][11][12][13].…”

Section: Introductionmentioning

confidence: 99%

Defining laboratory reference values and decision limits: populations, intervals, and interpretations

Boyd¹

2010

Asian J Androl

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This article provides a brief overview of various approaches that may be utilized for the analysis of human semen test results. Reference intervals are the most widely used tool for the interpretation of clinical laboratory results. Reference interval development has classically relied on concepts elaborated by the International Federation of Clinical Chemistry Expert Panel on Reference Values during the 1980s. These guidelines involve obtaining and classifying samples from a healthy population of at least 120 individuals and then identifying the outermost 5% of observations to use in defining limits for two-sided or one-sided reference intervals. More recently, decision limits based on epidemiological outcome analysis have also been introduced to aid in test interpretation. The reference population must be carefully defined on the basis of the intended clinical use of the underlying test. To determine appropriate reference intervals for use in male ferti lity assessment, a reference population of men with documented time to pregnancy of < 12 months would be most suitable. However, for epidemiological assessment of semen testing results, a reference population made up of unselected healthy men would be preferred. Although reference and decision limits derived for individual semen analysis test results will undoubtedly be the interpretational tools of choice in the near future, in the long term, multivariate methods for the interpretation of semen analysis alone or in combination with information from the female partner seem to represent better means for assessing the likelihood of achieving a successful pregnancy in a subfertile couple.

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Statistical Bases of Reference Values in Laboratory Medicine

Cited by 163 publications

References 0 publications

Biochemical measures in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS)¹

Biochemical measures in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS)¹

Cardiac Output and Central Distribution of Blood Flow in the Human Fetus

Defining laboratory reference values and decision limits: populations, intervals, and interpretations

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Statistical Bases of Reference Values in Laboratory Medicine

Cited by 163 publications

References 0 publications

Biochemical measures in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS)1

Biochemical measures in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS)1

Cardiac Output and Central Distribution of Blood Flow in the Human Fetus

Defining laboratory reference values and decision limits: populations, intervals, and interpretations

Contact Info

Product

Resources

About

Biochemical measures in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS)¹

Biochemical measures in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS)¹