Defining ranges for certainty ratings of diagnostic accuracy: A GRADE concept paper.

Monica Hultcrantz, Reem A Mustafa, Mariska M G Leeflang, Valéry Lavergne, Kelly Estrada-Orozco, Mohammed T Ansari, Ariel Izcovich, Jasvinder Singh, Lee Yee Chong, Anne Rutjes, Karen Steingart, Airton Stein, Nigar Sekercioglu, Ingrid Arévalo Rodriguez, Rebecca L Morgan, Gordon Guyatt, Patrick Bossuyt, Miranda W Langendam, Holger J Schünemann

Research output: Contribution to journalArticlepeer-review

28 Citations (Scopus)

Abstract

OBJECTIVE

To clarify how the Grading of Recommendations Assessment, Development and Evaluation (GRADE) concept of certainty of evidence applies to certainty ratings of test accuracy.

STUDY DESIGN AND SETTING

After initial brainstorming with GRADE Working Group members, we iteratively refined and clarified the approaches for defining ranges when assessing the certainty of evidence for test accuracy within a systematic review, health technology assessment, or guidelines.

RESULTS

Ranges can be defined both for single test accuracy and for comparative accuracy of multiple tests. For systematics reviews and health technology assessments, approaches for defining ranges include some that do not require value judgments regarding downstream health outcomes. Key challenges arise in the context of a guideline that requires ranges for sensitivity and specificity that are set considering possible effects on all critical outcomes. We illustrate possible approaches and provide an example from a systematic review of a direct comparison between two test strategies.

CONCLUSIONS

This GRADE concept paper provides a framework for assessing, presenting, and making decisions based on the certainty of evidence for test accuracy. More empirical research is needed to support future GRADE guidance on how to best operationalize the candidate approaches.

Original languageEnglish
Pages (from-to)138-148
Number of pages11
JournalJournal of Clinical Epidemiology
Volume117
Early online date18 May 2019
DOIs
Publication statusPublished - 1 Jan 2020

Keywords

  • Certainty of evidence
  • GRADE
  • Guidelines
  • Health technology assessments
  • Systematic reviews
  • Test accuracy

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