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Table 4 Proposed modifications to the QUADAS background document*

From: Evaluation of QUADAS, a tool for the quality assessment of diagnostic accuracy studies

13. Were uninterpretable/intermediate test results reported?

c. How to score this item

If it is clear that all test results, including uninterpretable/indeterminate/intermediate are reported then this item should be scored as "yes". If the authors do not report any uninterpretable/indeterminate/intermediate results, and if results are reported for all patients who were described as having been entered into the study then this item should also be scored as "yes". If you think that such results occurred but have not been reported then this item should be scored as "no". If it is not clear whether all study results have been reported then this item should be scored as "unclear".

14. Were withdrawals from the study explained?

c. How to score this item

If it is clear what happened to all patients who entered the study, for example if a flow diagram of study participants is reported, then this item should be scored as "yes". If the authors do not report any withdrawals and if results are available for all patients who were reported to have been entered into the study then this item should also be scored as "yes". If it appears that some of the participants who entered the study did not complete the study, i.e. did not receive both the index test and reference standard, and these patients were not accounted for then this item should be scored as "no". If it is not clear whether all patients who entered the study were accounted for then this item should be scored as "unclear".

* Proposed changes are highlighted in bold

  1. *Each of these items were rated from 1–5 where 1 is strongly disagree (very poor) and 5 is strongly agree (excellent)