Abstract
BackgroundDrawing conclusions from systematic reviews of test accuracy studies without considering the methodological quality (risk of bias) of included studies may lead to unwarranted optimism about the value of the test(s) under study. We sought to identify to what extent the results of quality assessment of included studies are incorporated in the conclusions of diagnostic accuracy reviews.MethodsWe searched MEDLINE and EMBASE for test accuracy reviews published between May and September 2012. We examined the abstracts and main texts of these reviews to see whether and how the results of quality assessment were linked to the accuracy estimates when drawing conclusions.ResultsWe included 65 reviews of which 53 contained a meta-analysis. Sixty articles (92%) had formally assessed the methodological quality of included studies, most often using the original QUADAS tool (n = 44, 68%). Quality assessment was mentioned in 28 abstracts (43%); with a majority (n = 21) mentioning it in the methods section. In only 5 abstracts (8%) were results of quality assessment incorporated in the conclusions. Thirteen reviews (20%) presented results of quality assessment in the main text only, without further discussion. Forty-seven reviews (72%) discussed results of quality assessment; the most frequent form was as limitations in assessing quality (n = 28). Only 6 reviews (9%) further linked the results of quality assessment to their conclusions, 3 of which did not conduct a meta-analysis due to limitations in the quality of included studies. In the reviews with a meta-analysis, 19 (36%) incorporated quality in the analysis. Eight reported significant effects of quality on the pooled estimates; in none of them these effects were factored in the conclusions.ConclusionWhile almost all recent diagnostic accuracy reviews evaluate the quality of included studies, very few consider results of quality assessment when drawing conclusions. The practice of reporting systematic reviews of test accuracy should improve if readers not only want to be informed about the limitations in the available evidence, but also on the associated implications for the performance of the evaluated tests.
Highlights
Drawing conclusions from systematic reviews of test accuracy studies without considering the methodological quality of included studies may lead to unwarranted optimism about the value of the test(s) under study
We examined the main body of the review to check if the methodological quality of included studies was assessed, which tool had been used to assess quality, how results of quality assessments were presented, if the quality of studies had influenced the decision to perform a meta-analysis, if and how an assessment of quality was incorporated into the analysis, and if and how the results of quality assessment were discussed and eventually used in drawing conclusions about the test
Sixty-five reviews were eventually included in this study on quality assessment
Summary
Drawing conclusions from systematic reviews of test accuracy studies without considering the methodological quality (risk of bias) of included studies may lead to unwarranted optimism about the value of the test(s) under study. Limitations in the design and conduct of the study may lead to overestimation of the accuracy of the test under study [5,6] This is of concern, because tests introduced in practice based on weak evidence may lead to misdiagnosis, improper management of patients and, subsequently, poor health outcomes [7,8,9]. The Quality Assessment for Diagnostic Accuracy Studies tool (QUADAS) has been developed and introduced to evaluate the methodological quality of studies included in systematic reviews of test accuracy [10]. The revised instrument considers methodological quality in terms of risk of bias and concerns regarding the applicability of findings to the research question It does so in four key domains: patient selection, index test, reference test, and patient flow [11].
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