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Selecting clinically relevant populations for reference intervals

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Published/Copyright: June 1, 2005

Abstract

The selection of individuals to represent a group for any purpose can commit the effort to success or failure from the very outset. The description of this group must reflect what is, in reality, the purpose for which the group is being studied. Considering that reference intervals are designed to assist clinicians during diagnostic triage, criteria must reflect the nature of the subjects entering the system for care. The majority of people seeking care have non-life-threatening, yet troublesome complaints. In other words, persons who are in a reasonable state of health and who are not suffering from significant illness. Therefore the relevant cohort should fit this description, not individuals who lack any clinical or laboratory issues. Our focus is to employ reference intervals to exclude disease and not to define normality. Normality in the eyes of statisticians is quite different from the word as viewed by clinical staff, yet the term is used interchangeably without concern for its ultimate use. As a result medicine today stumbles over this issue at every turn. Scientists and artists do not speak the same language.

Compounding this awkward situation has been the conviction that by increasing laboratory precision and accuracy, the utility of laboratory data, reference intervals in particular, will improve clinical understanding. This has, after many years, not proven to be the case. What has become very evident, however, is that unsustainably large sums of money are being devoted to improving laboratory performance. To what end, when we are unable to grasp the significance of what is available now including published reference intervals for common test values?

A realistic perspective on the value of prevailing laboratory performance, as illustrated by reference intervals, must be adopted. The obligation of laboratories, its regulators and professional groups is to create a sustainable mechanism to provide clinically usable information, in a timely and affordable manner, to our population and to those legions of less fortunate humans.

Published Online: 2005-6-1
Published in Print: 2004-7-5

Copyright © 2004 by Walter de Gruyter GmbH & Co. KG

Articles in the same Issue

  1. Editors introduction
  2. Reference values: from philosophy to a tool for laboratory medicine
  3. The evolution of the reference value concept
  4. Normality: the unreachable star?
  5. Selecting clinically relevant populations for reference intervals
  6. The IFCC recommendation on estimation of reference intervals. The RefVal Program
  7. Graphical interpretation of confidence curves in rankit plots
  8. Partitioning biochemical reference data intosubgroups: comparison of existing methods
  9. Parametric methods for estimating covariate-dependent reference limits
  10. Reference regions of two or more dimensions
  11. Should we maintain the 95 percent reference intervals in the era of wellness testing? A concept paper
  12. Clinical interpretation of reference intervals and reference limits. A plea for assay harmonization
  13. Inherent biological variation and reference values
  14. Intraindividual reference values
  15. Guideline for the production of multicentre physiological reference values using the same measurement system. A proposal of the Catalan Association for Clinical Laboratory Sciences
  16. Proposal for guidelines to establish common biological reference intervals in large geographical areas for biochemical quantities measured frequently in serum and plasma
  17. Reference intervals for plasma proteins: similarities and differences between adult Caucasian and Asian Indian males in Yorkshire, UK
  18. Diagnostic and epidemiological implications of regional differences in serum concentrations of proteins observed in six Asian cities
  19. Study of reference values and biological variation: a necessity and a model for Preventive Medicine Centers
  20. Creation of a low-risk reference group and referenceinterval of fasting venous plasma glucose
  21. Establishment of a serum thyroid stimulating hormone (TSH) reference interval in healthy adults. The importance of environmental factors, including thyroid antibodies
  22. Difficulties in establishing reference intervals for special fluids: the example of 5-hydroxyindoleacetic acid and homovanillic acid in cerebrospinal fluids
  23. Metrological traceability of calibration in the estimation and use of common medical decision-making criteria
  24. Creation of the necessary analytical quality for generating and using reference intervals
  25. Analytical quality specifications for common reference intervals
  26. Design of internal quality control for reference value studies
  27. The NEXUS vision: an alternative to the reference value concept
  28. Meetings and Awards
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