Abstract
BackgroundQUADOMICS is an adaptation of QUADAS (a quality assessment tool for use in systematic reviews of diagnostic accuracy studies), which takes into account the particular challenges presented by ‘-omics’ based technologies. Our primary objective was to evaluate the applicability and consistency of QUADOMICS. Subsequently we evaluated and describe the methodological quality of a sample of recently published studies using the tool.Methodology/Principal Findings45‘-omics’- based diagnostic studies were identified by systematic search of Pubmed using suitable MeSH terms (“Genomics”, “Sensitivity and specificity”, “Diagnosis”). Three investigators independently assessed the quality of the articles using QUADOMICS and met to compare observations and generate a consensus. Consistency and applicability was assessed by comparing each reviewer's original rating with the consensus. Methodological quality was described using the consensus rating. Agreement was above 80% for all three reviewers. Four items presented difficulties with application, mostly due to the lack of a clearly defined gold standard. Methodological quality of our sample was poor; studies met roughly half of the applied criteria (mean ± sd, 54.7±18.4%). Few studies were carried out in a population that mirrored the clinical situation in which the test would be used in practice, (6, 13.3%); none described patient recruitment sufficiently; and less than half described clinical and physiological factors that might influence the biomarker profile (20, 44.4%).ConclusionsThe QUADOMICS tool can consistently be applied to diagnostic ‘-omics’ studies presently published in biomedical journals. A substantial proportion of reports in this research field fail to address design issues that are fundamental to make inferences relevant for patient care.
Highlights
Technological advances in the past 20 years have permitted large-scale parallel measurements of biochemical and cellular constituents for study as a unified whole, spurring what may be referred to as the ‘-omics’ revolution. [1,2,3] By adding the suffix ‘omics’, we can refer to the comprehensive study of almost any cellular constituent
The study consisted of two parts: 1) the evaluation of the applicability and consistency of the QUADOMICS tool, and 2) the evaluation of the methodological quality of a selection of recent published studies
The lack of an independent reference test is a common problem in studies that seek to validate the diagnostic application of new ‘-omics’ based technologies and it contributed to difficulties in the application of the QUADOMICS items that refer to the reference standard
Summary
Technological advances in the past 20 years have permitted large-scale parallel measurements of biochemical and cellular constituents for study as a unified whole, spurring what may be referred to as the ‘-omics’ revolution. [1,2,3] By adding the suffix ‘omics’, we can refer to the comprehensive study of almost any cellular constituent. Transcriptomics refers to analysis of total mRNA expression and proteomics refers to the analysis of the proteome, the total protein content The coupling of these high throughput technologies with computer-assisted discrimination systems may substantially influence the future of clinical diagnosis, leading to diagnostic tests based on multi-marker patterns, biomarker profiles or signatures, rather than on a single alteration [1,4]. QUADOMICS is an adaptation of QUADAS (a quality assessment tool for use in systematic reviews of diagnostic accuracy studies), which takes into account the particular challenges presented by ‘-omics’ based technologies. We evaluated and describe the methodological quality of a sample of recently published studies using the tool
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