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BMJ readers are suggesting a number of solutions to wrong results
affecting biochemistry results (1). Elsewhere (2), some of the
correspondents state on the same topic that “the users of diagnostic
reagents, and of the measurement data obtained with them, must recognise
their responsibility to provide laboratory data that do not violate
patients' safety and the quality of clinical research”.
In my opinion, this sentence reveals a problem that goes far beyond
interferences in immunoassays. That theme relates to the accuracy of
tests, where “accuracy” means the proximity to the truth and the word
“test” can be referred “to any method for obtaining additional information
on a patient’s health status”(3). As Joseph Watine states to the point in
this journal (4) “Published reports on diagnostic accuracy of medical
tests frequently fail to adhere to minimal clinical epidemiological
standards, and such failures lead to overly optimistic assessments of
evaluated tests”.
Such could be the situation in case-control studies, in which “the
results are based on a comparison of people who obviously have the disease
with normal volunteers who clearly do not”(5). When the validation of a
diagnostic test is so affected by spectrum bias, or sample size is too
small, even the mentioned immunochemical interferences can most likely
overlooked.
So, that biochemistry problem looks the tip of the iceberg.
Accordingly, I think the cooperation to be implemented should be much
wider than interdepartmental, like that suggested by Bonini and Plebani in
their response to the above article (1). Clinical and laboratory-medicine
societies should be invested with correct performing and reporting
diagnostic studies in every field, because targets are common. One
important aspect of this cooperation could be the translation of most
crucial pieces of literature from English into national languages. While
waiting the results of novel trends in education this seems to me a major
requirement in Italy.
(3) The STARD Group. Towards complete and accurate reporting of
studies on diagnostic accuracy: the STARD initiative (test version,
November 2001) http://www.consort-statement.org/
(4) Watine J.What about studies of diagnostic accuracy? (e-response
to Smith R.A plea to authors: ensure your studies comply with
guidelines.BMJ 2002;324:314 http://bmj.com/cgi/content/full/324/7333/314
)
(5) Haynes RB. Keeping up to date with the best evidence concerning
diagnostic tests. In: Diagnostic strategies for common medical problems,
p. 36-45. Black, Bordley, Tape, Panzer Eds (2nd Ed, 1999). American
College of Physicians, Philadelphia.
What’s wrong, where it is, how to let people be informed about
Sir,
BMJ readers are suggesting a number of solutions to wrong results
affecting biochemistry results (1). Elsewhere (2), some of the
correspondents state on the same topic that “the users of diagnostic
reagents, and of the measurement data obtained with them, must recognise
their responsibility to provide laboratory data that do not violate
patients' safety and the quality of clinical research”.
In my opinion, this sentence reveals a problem that goes far beyond
interferences in immunoassays. That theme relates to the accuracy of
tests, where “accuracy” means the proximity to the truth and the word
“test” can be referred “to any method for obtaining additional information
on a patient’s health status”(3). As Joseph Watine states to the point in
this journal (4) “Published reports on diagnostic accuracy of medical
tests frequently fail to adhere to minimal clinical epidemiological
standards, and such failures lead to overly optimistic assessments of
evaluated tests”.
Such could be the situation in case-control studies, in which “the
results are based on a comparison of people who obviously have the disease
with normal volunteers who clearly do not”(5). When the validation of a
diagnostic test is so affected by spectrum bias, or sample size is too
small, even the mentioned immunochemical interferences can most likely
overlooked.
So, that biochemistry problem looks the tip of the iceberg.
Accordingly, I think the cooperation to be implemented should be much
wider than interdepartmental, like that suggested by Bonini and Plebani in
their response to the above article (1). Clinical and laboratory-medicine
societies should be invested with correct performing and reporting
diagnostic studies in every field, because targets are common. One
important aspect of this cooperation could be the translation of most
crucial pieces of literature from English into national languages. While
waiting the results of novel trends in education this seems to me a major
requirement in Italy.
Thanks,
Giuseppe Giocoli, MD
Gruppo di lavoro EBM –AMCLI
gioco.en@numerica.it
(1) Ismail AAA, Barth JH. Wrong biochemistry results. BMJ 2001; 323:
705-6 (and ensuing e-responses at
http://bmj.com/cgi/content/full/324/7334/422/a#Fu1)
(2) Lindstedt G, Frändberg S.Unreliable immunoassays, patients'
safety, and clinical research. . Lancet 2002; 359: 356-7.
http://pdf.thelancet.com/pdfdownload?uid=llan.359.9303.correspondence.19...
(3) The STARD Group. Towards complete and accurate reporting of
studies on diagnostic accuracy: the STARD initiative (test version,
November 2001) http://www.consort-statement.org/
(4) Watine J.What about studies of diagnostic accuracy? (e-response
to Smith R.A plea to authors: ensure your studies comply with
guidelines.BMJ 2002;324:314 http://bmj.com/cgi/content/full/324/7333/314
)
(5) Haynes RB. Keeping up to date with the best evidence concerning
diagnostic tests. In: Diagnostic strategies for common medical problems,
p. 36-45. Black, Bordley, Tape, Panzer Eds (2nd Ed, 1999). American
College of Physicians, Philadelphia.
Competing interests: No competing interests