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Assessing the certainty of evidence of test accuracy studies when there are challenges with establishing a reference standard-response to comments from Dr. Reed

  • Reem A. Mustafa
    Correspondence
    Corresponding author. Division of Nephrology and Hypertension, Professor of Population Health, Director, Outcomes and Implementation Research, JGKI, University of Kansas Medical Center, 3901 Rainbow Blvd, MS3002, Kansas City, KS 66160, USA. Tel.: + 913 588 6048; fax: + 1 913 588 6074.
    Affiliations
    Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Centre, 3901 Rainbow Blvd, MS3002, Kansas City, KS 61160, USA

    Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada
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  • Holger J. Schünemann
    Affiliations
    Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada

    Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8 Ontario, Canada

    Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele (Milano), Italy

    Institute for Evidence in Medicine, Medical Center and Faculty of Medicine, University of Freiburg, Freiburg, Germany
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Published:December 19, 2022DOI:https://doi.org/10.1016/j.jclinepi.2022.11.018
Assessing the certainty of evidence of test accuracy studies when there are challenges with establishing a reference standard-response to comments from Dr. Reed
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      We appreciate Dr. Reed's response and agree with him that better collaboration on defining criteria for developing reference standards for assessing the accuracy of diagnostic imaging when a gold standard cannot be used is needed. We have made early conceptual progress in earlier papers on rating the certainty but the issue raised is an important one [
      • Schunemann H.J.
      • Mustafa R.A.
      • Brozek J.
      • Steingart K.R.
      • Leeflang M.
      • Murad M.H.
      • et al.
      GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables.
      J Clin Epidemiol. 2020; 122: 142-152
      ,
      • Schunemann H.J.
      • Mustafa R.A.
      • Brozek J.
      • Steingart K.R.
      • Leeflang M.
      • Murad M.H.
      • et al.
      GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy.
      J Clin Epidemiol. 2020; 122: 129-141
      ,
      • Mustafa R.A.
      • Wiercioch W.
      • Ventresca M.
      • Brozek J.
      • Schünemann H.J.
      DU-Diagnosis expert group
      Decision making about healthcare-related tests and diagnostic test strategies. Paper 5: a qualitative study with experts suggests that test accuracy data alone is rarely sufficient for decision making.
      J Clin Epidemiol. 2017; 92: 47-57
      ,
      • Schunemann H.J.
      • Mustafa R.
      • Brozek J.
      [Diagnostic accuracy and linked evidence–testing the chain].
      Z Evid Fortbild Qual Gesundhwes. 2012; 106: 153-160
      ]. However, we still believe that diagnostic imaging faces similar issues as other areas, for example, the diagnosis of tuberculosis through new molecular tests where reference standards may not be the gold standard. Thus, the methodological challenges will be similar although the topics to be addressed in diagnostic imaging are specific. We are looking forward to working together on these challenges in the Grading of Recommendations, Assessment, Development and Evaluation project group on tests and diagnosis with Dr. Reed and others.
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      References

        • Schunemann H.J.
        • Mustafa R.A.
        • Brozek J.
        • Steingart K.R.
        • Leeflang M.
        • Murad M.H.
        • et al.
        GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables.
        J Clin Epidemiol. 2020; 122: 142-152
        View in Article
        • Schunemann H.J.
        • Mustafa R.A.
        • Brozek J.
        • Steingart K.R.
        • Leeflang M.
        • Murad M.H.
        • et al.
        GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy.
        J Clin Epidemiol. 2020; 122: 129-141
        View in Article
        • Mustafa R.A.
        • Wiercioch W.
        • Ventresca M.
        • Brozek J.
        • Schünemann H.J.
        • DU-Diagnosis expert group
        Decision making about healthcare-related tests and diagnostic test strategies. Paper 5: a qualitative study with experts suggests that test accuracy data alone is rarely sufficient for decision making.
        J Clin Epidemiol. 2017; 92: 47-57
        View in Article
        • Schunemann H.J.
        • Mustafa R.
        • Brozek J.
        [Diagnostic accuracy and linked evidence–testing the chain].
        Z Evid Fortbild Qual Gesundhwes. 2012; 106: 153-160
        View in Article

      Article info

      Publication history

      Published online: December 19, 2022
      Accepted: November 24, 2022

      Publication stage

      In Press Journal Pre-Proof

      Footnotes

      Conflict of interest: None to declare.

      Identification

      DOI: https://doi.org/10.1016/j.jclinepi.2022.11.018

      Copyright

      © 2022 Elsevier Inc. All rights reserved.

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