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Selected Works of Sally Lord
Article
Setting analytical performance specifications based on outcome studies - is it possible?
Clinical Chemistry and Laboratory Medicine (2015)
  • Andrea Rita Horvath, Prince of Wales Hospital
  • Patrick Bossuyt, University of Amsterdam
  • Sverre Sandberg, University of Bergen
  • Andrew St John, ARC Consulting
  • Phillip Monaghan, The Christie Hospital NHS Foundation Trust
  • Wilma Verhagen-Kamerbeek, Roche Diagnostics International
  • Lieselotte Lennartz, Abbott Diagnostics
  • Christa Cobbaert, Leiden University
  • Christoph Ebert, Roche Diagnostics
  • Sally Lord, The University of Notre Dame Australia
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Abstract
The 1st Strategic Conference of the European Federation
of Clinical Chemistry and Laboratory Medicine proposed
a simplified hierarchy for setting analytical performance
specifications (APS). The top two levels of the 1999
Stockholm hierarchy, i.e., evaluation of the effect of analytical
performance on clinical outcomes and clinical decisions
have been proposed to be replaced by one outcomebased
model. This model can be supported by: (1a) direct
outcome studies; and (1b) indirect outcome studies investigating
the impact of analytical performance of the test
on clinical classifications or decisions and thereby on the
probability of patient relevant clinical outcomes.
This paper reviews the need for outcome-based specifications,
the most relevant types of outcomes to be considered,
and the challenges and limitations faced when
setting outcome-based APS. The methods of Model 1a
and b are discussed and examples are provided for how
outcome data can be translated to APS using the linked
evidence and simulation or decision analytic techniques.
Outcome-based APS should primarily reflect the clinical
needs of patients; should be tailored to the purpose,
role and significance of the test in a well defined clinical
pathway; and should be defined at a level that achieves
net health benefit for patients at reasonable costs. Whilst
it is acknowledged that direct evaluations are difficult and
may not be possible for all measurands, all other forms
of setting APS should be weighed against that standard,
and regarded as approximations. Better definition of the
relationship between the analytical performance of tests
and health outcomes can be used to set analytical performance
criteria that aim to improve the clinical and costeffectiveness
of laboratory tests.
Disciplines
Publication Date
2015
DOI
10.1515/cclm-2015-0214
Citation Information
Horvath, A., Bossuyt, P., Sandberg, S., St John, A., Monaghan, P., Verhagen-Kamerbeek, W., Lennartz, L., Cobbaert, C., Ebert, C., and Lord, S. (2015). Setting analytical performance specifications based on outcome studies - is it possible? Clinical Chemistry and Laboratory Medicine, 53(6), 841-848. DOI: 10.1515/cclm-2015-0214