Overinterpretation of Clinical Applicability in Molecular Diagnostic Research
Open Access
- 1 April 2009
- journal article
- research article
- Published by Oxford University Press (OUP) in Clinical Chemistry
- Vol. 55 (4), 786-794
- https://doi.org/10.1373/clinchem.2008.121517
Abstract
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.Keywords
Funding Information
- Instituto de Salud Carlos III
This publication has 22 references indexed in Scilit:
- Reporting of Human Genome Epidemiology (HuGE) association studies: An empirical assessmentBMC Medical Research Methodology, 2008
- Enabling personalized cancer medicine through analysis of gene-expression patternsNature, 2008
- Assessing the social meaning, value and implications of research in genomicsJournal of Epidemiology and Community Health, 2007
- Is Molecular Profiling Ready for Use in Clinical Decision Making?The Oncologist, 2007
- The Proteomic Search for Diagnostic BiomarkersMolecular & Cellular Proteomics, 2006
- Molecular BiasEuropean Journal of Epidemiology, 2005
- Running before we can walk?Nature, 2004
- Methodology in Diagnostic Laboratory Test Research in Clinical Chemistry and Clinical Chemistry and Laboratory MedicineClinical Chemistry, 2004
- Effect of interpretive bias on research evidenceBMJ, 2003
- The winding road towards evidence based diagnosesJournal of Epidemiology and Community Health, 2002