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Overinterpretation of Clinical Applicability in Molecular Diagnostic Research

¹ Public Health Department, Miguel Hernández University, Alicante, Spain [CIBER en Epidemiología y Salud Pública (CIBERESP)]; ² Institut Municipal d’Investigació Mèdica, Facultat de Medicina, Universitat Autònoma de Barcelona, Spain [CIBER en Epidemiología y Salud Pública (CIBERESP)];³ Cancer and Environmental Epidemiology Area, National Centre for Epidemiology, Instituto de Salud Carlos III, Madrid, Spain [CIBER en Epidemiología y Salud Pública (CIBERESP)];⁴ Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.

^aAddress correspondence to this author at: Public Health Department, Miguel Hernández University, E-03550 Alicante, Spain. Fax +34 965 919551; e-mail lparker{at}umh.es.

Background: We evaluated whether articles on molecular diagnostic tests interpret appropriately the clinical applicability of their results.

Methods: We selected original-research articles published in 2006 that addressed the diagnostic value of a molecular test. We defined overinterpretation of clinical applicability by means of prespecified rules that evaluated study design, conclusions regarding applicability, presence of statements suggesting the need for further clinical evaluation of the test, and diagnostic accuracy. Two reviewers independently evaluated the articles; consensus was reached after discussion and arbitration by a third reviewer.

Results: Of 108 articles included in the study, 82 (76%) used a design that used healthy controls or alternative-diagnosis controls, only 15 (11%) addressed a clinically relevant population similar to that in which the test might be applied in practice, 104 articles (96%) made definitely favorable or promising statements regarding clinical applicability, and 61 (56%) of the articles apparently overinterpreted the clinical applicability of their findings. Articles published in journals with higher impact factors were more likely to overinterpret their results than those with lower impact factors (adjusted odds ratio, 1.71 per impact factor quartile; 95% CI, 1.09–2.69; P = 0.020). Overinterpretation was more common when authors were based in laboratories than in clinical settings (adjusted odds ratio, 18.7; 95% CI, 1.41–249; P = 0.036).

Conclusions: Although expectations are high for new diagnostic tests based on molecular techniques, the majority of published research has involved preclinical phases of research. Overinterpretation of the clinical applicability of findings for new molecular diagnostic tests is common.