BACKGROUND: In the era of evidence based medicine, with systematic reviews as itscornerstone, adequate quality assessment tools should be available. There iscurrently a lack of a systematically developed and evaluated tool for theassessment of diagnostic accuracy studies. The aim of this project was to combineempirical evidence and expert opinion in a formal consensus method to develop atool to be used in systematic reviews to assess the quality of primary studies ofdiagnostic accuracy.METHODS: We conducted a Delphi procedure to develop the quality assessment toolby refining an initial list of items. Members of the Delphi panel were experts inthe area of diagnostic research. The results of three previously conductedreviews of the diagnostic literature were used to generate a list of potentialitems for inclusion in the tool and to provide an evidence base upon which todevelop the tool.RESULTS: A total of nine experts in the field of diagnostics took part in theDelphi procedure. The Delphi procedure consisted of four rounds, after whichagreement was reached on the items to be included in the tool which we havecalled QUADAS. The initial list of 28 items was reduced to fourteen items in the final tool. Items included covered patient spectrum, reference standard, disease progression bias, verification bias, review bias, clinical review bias,incorporation bias, test execution, study withdrawals, and indeterminate results.The QUADAS tool is presented together with guidelines for scoring each of theitems included in the tool.CONCLUSIONS: This project has produced an evidence based quality assessment tool to be used in systematic reviews of diagnostic accuracy studies. Further work to determine the usability and validity of the tool continues.
The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews
Rutjes A;
2003-01-01
Abstract
BACKGROUND: In the era of evidence based medicine, with systematic reviews as itscornerstone, adequate quality assessment tools should be available. There iscurrently a lack of a systematically developed and evaluated tool for theassessment of diagnostic accuracy studies. The aim of this project was to combineempirical evidence and expert opinion in a formal consensus method to develop atool to be used in systematic reviews to assess the quality of primary studies ofdiagnostic accuracy.METHODS: We conducted a Delphi procedure to develop the quality assessment toolby refining an initial list of items. Members of the Delphi panel were experts inthe area of diagnostic research. The results of three previously conductedreviews of the diagnostic literature were used to generate a list of potentialitems for inclusion in the tool and to provide an evidence base upon which todevelop the tool.RESULTS: A total of nine experts in the field of diagnostics took part in theDelphi procedure. The Delphi procedure consisted of four rounds, after whichagreement was reached on the items to be included in the tool which we havecalled QUADAS. The initial list of 28 items was reduced to fourteen items in the final tool. Items included covered patient spectrum, reference standard, disease progression bias, verification bias, review bias, clinical review bias,incorporation bias, test execution, study withdrawals, and indeterminate results.The QUADAS tool is presented together with guidelines for scoring each of theitems included in the tool.CONCLUSIONS: This project has produced an evidence based quality assessment tool to be used in systematic reviews of diagnostic accuracy studies. Further work to determine the usability and validity of the tool continues.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
