Article type
Year
Abstract
Background: A QUADAS tool was recently developed1 to assess the quality of diagnostic studies, and could be applied to evaluate screening tests. The Canadian Agency for Drugs and Technologies in Health (CADTH) undertook a health technology assessment (HTA) report evaluating the efficacy and cost-effectiveness of tandem mass spectrometry (MS/MS) in newborn screening for medium chain acyl~CoA dehydrogenase deficiency (MCADD).
Objectives: To assess the quality of studies of newborn screening for MCADD using the QUADAS tool.
Methods: Relevant literature was obtained by searching electronic databases and websites using a pre-defined strategy. The QUADAS tool consists of 14 questions that can be answered as yes (Y), no (N) or unclear (U), covering bias (items 3, 4, 5, 6, 7, 10, 11, 12, 14), variability (items 1, 2) and quality of reporting (items 8, 9, 13).
Results: Fourteen studies were subjected to quality assessment. Of the tool's 14 questions, items 5, 6, 11 and 12 are more specific for diagnostic testing than screening tests. Only 14% (2/14) of the studies scored Y on variability items 1 and 2. Among bias related items 3, 4, 7, 10 and 14, items 3, 7 and 10 were scored Y from 78.6% (11/14), 78.6% (11/14) and 100% (14/14) of the studies, respectively, indicating that most studies used an appropriate reference standard to classify the target condition correctly, although none of the studies reported about withdrawals (item 14) or the time between the reference standard and the screening test (item 4). Item 13 for reporting of uninterpretable/ intermediate test results scored N in all studies. Only 43% (6/14) and 21% (3/14) of the studies described sufficient detail of the screening test (item 8) and reference standard (item 9), respectively.
Conclusions: Studies on newborn screening for MCADD scored poorly on some items covering bias, variability and reporting of the QUADAS tool.
References
1. Whiting P, Rutjes AWS, Reitsma JB, Bossuyt PMM, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Medical Research Methodology 2003; 3:25.
Objectives: To assess the quality of studies of newborn screening for MCADD using the QUADAS tool.
Methods: Relevant literature was obtained by searching electronic databases and websites using a pre-defined strategy. The QUADAS tool consists of 14 questions that can be answered as yes (Y), no (N) or unclear (U), covering bias (items 3, 4, 5, 6, 7, 10, 11, 12, 14), variability (items 1, 2) and quality of reporting (items 8, 9, 13).
Results: Fourteen studies were subjected to quality assessment. Of the tool's 14 questions, items 5, 6, 11 and 12 are more specific for diagnostic testing than screening tests. Only 14% (2/14) of the studies scored Y on variability items 1 and 2. Among bias related items 3, 4, 7, 10 and 14, items 3, 7 and 10 were scored Y from 78.6% (11/14), 78.6% (11/14) and 100% (14/14) of the studies, respectively, indicating that most studies used an appropriate reference standard to classify the target condition correctly, although none of the studies reported about withdrawals (item 14) or the time between the reference standard and the screening test (item 4). Item 13 for reporting of uninterpretable/ intermediate test results scored N in all studies. Only 43% (6/14) and 21% (3/14) of the studies described sufficient detail of the screening test (item 8) and reference standard (item 9), respectively.
Conclusions: Studies on newborn screening for MCADD scored poorly on some items covering bias, variability and reporting of the QUADAS tool.
References
1. Whiting P, Rutjes AWS, Reitsma JB, Bossuyt PMM, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Medical Research Methodology 2003; 3:25.