The DOI matches its Crossref record; 13 of the 13 references it cites were found in a registry or an index.
GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy
Open accessAbstract
OBJECTIVES This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments (HTA) and guideline developers can assess the results and the certainty of evidence (also known as quality of the evidence or confidence in the estimates) of a body of evidence addressing test accuracy (TA). STUDY DESIGN AND SETTING We present an overview of the GRADE approach and guidance for rating certainty in TA in clinical and public health and review the presentation of results of a body of evidence regarding tests. Part 1 of the two parts in this 21st guidance article about how to apply GRADE focuses on understanding study design issues in test accuracy, provide an overiew of the domains and describe risk of bias and indirectness specifically. RESULTS Supplemented by practical examples, we describe how raters of the evidence using GRADE can evaluate study designs focusing on tests and how they apply the GRADE domains risk of bias and indirectness to a body of evidence of TA studies. CONCLUSIONS Rating the certainty of a body of evidence using GRADE in Cochrane and other reviews and World Health Organization and other guidelines dealing with in TA studies helped refining our approach. The resulting guidance will help applying GRADE successfully for questions and recommendations focusing on tests.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies
Whiting, P. F., Rutjes, A. W. S., Westwood, M. E., Mallett, S., Deeks, J. J., Reitsma, J. B., Leeflang, M. M. G., Sterne, J. A. C., Bossuyt, P. M. M., & the QUADAS-2 Group* (2011) · Annals of Internal Medicine · doi:10.7326/0003-4819-155-8-201110180-00009 · Cited by 14,199
Self-citationGRADE guidelines: 1. Introduction—GRADE evidence profiles and summary of findings tables
Guyatt, G., Oxman, A. D., Akl, E. A., Kunz, R., Vist, G., Brozek, J., Norris, S., Falck-Ytter, Y., Glasziou, P., & deBeer, H. (2011) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2010.04.026 · Cited by 10,681
Self-citationWhiting, P., Rutjes, A. W., Reitsma, J. B., Bossuyt, P. M., & Kleijnen, J. (2003) · BMC Medical Research Methodology · doi:10.1186/1471-2288-3-25 · Cited by 3,592
Self-citationTowards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative
Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., Lijmer, J. G., Moher, D., Rennie, D., & de Vet, H. C. W. (2003) · BMJ · doi:10.1136/bmj.326.7379.41 · Cited by 3,215
Self-citationTowards Complete and Accurate Reporting of Studies of Diagnostic Accuracy: The STARD Initiative
Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., Lijmer, J. G., Moher, D., Rennie, D., & de Vet, H. C. W. (2003) · Radiology · doi:10.1148/radiol.2261021292 · Cited by 3,215
Self-citationGRADE guidelines: a new series of articles in the Journal of Clinical Epidemiology
Guyatt, G. H., Oxman, A. D., Schünemann, H. J., Tugwell, P., & Knottnerus, A. (2011) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2010.09.011 · Cited by 3,094
Self-citationGRADE guidelines: 2. Framing the question and deciding on important outcomes
Guyatt, G. H., Oxman, A. D., Kunz, R., Atkins, D., Brozek, J., Vist, G., Alderson, P., Glasziou, P., Falck-Ytter, Y., & Schünemann, H. J. (2011) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2010.09.012 · Cited by 1,911
Self-citationEmpirical evidence of design-related bias in studies of diagnostic tests.
Lijmer, J. G. (1999) · JAMA · doi:10.1001/jama.282.11.1061 · Cited by 1,861
Puhan, M. A., Schunemann, H. J., Murad, M. H., Li, T., Brignardello-Petersen, R., Singh, J. A., Kessels, A. G., Guyatt, G. H., & for the GRADE Working Group (2014) · BMJ · doi:10.1136/bmj.g5630 · Cited by 1,812
Self-citationGrading quality of evidence and strength of recommendations for diagnostic tests and strategies
Schünemann, H. J., Oxman, A. D., Brozek, J., Glasziou, P., Jaeschke, R., Vist, G. E., Williams, J. W., Kunz, R., Craig, J., Montori, V. M., et al. (2008) · BMJ · doi:10.1136/bmj.39500.677199.ae · Cited by 1,782
Self-citation
Cited by
False-negative results of initial RT-PCR assays for COVID-19: A systematic review
Arevalo-Rodriguez, I., Buitrago-Garcia, D., Simancas-Racines, D., Zambrano-Achig, P., Del Campo, R., Ciapponi, A., Sued, O., Martinez-García, L., Rutjes, A. W., Low, N., et al. (2020) · PLOS ONE · doi:10.1371/journal.pone.0242958 · Cited by 656
Self-citationASH ISTH NHF WFH 2021 guidelines on the diagnosis of von Willebrand disease
James, P. D., Connell, N. T., Ameer, B., Di Paola, J., Eikenboom, J., Giraud, N., Haberichter, S., Jacobs-Pratt, V., Konkle, B., McLintock, C., et al. (2021) · Blood Advances · doi:10.1182/bloodadvances.2020003265 · Cited by 586
Self-citationKohli, M., Schiller, I., Dendukuri, N., Yao, M., Dheda, K., Denkinger, C. M., Schumacher, S. G., & Steingart, K. R. (2021) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012768.pub3 · Cited by 215
Self-citationShi, C., Goodall, M., Dumville, J., Hill, J., Norman, G., Hamer, O., Clegg, A., Watkins, C. L., Georgiou, G., Hodkinson, A., et al. (2022) · doi:10.1101/2022.02.16.22271062 · Cited by 158
“One reviewer (CS) assessed the certainty of evidence on mean bias by referring to the GRADE approach developed for the test accuracy topic, checked by another reviewer (GN).[28,29] Using this approach the certainty of mean bias findings could be assessed as at high, moderate, low or very low certainty.”
MethodLeung, A. A., Symonds, C. J., Hundemer, G. L., Ronksley, P. E., Lorenzetti, D. L., Pasieka, J. L., Harvey, A., & Kline, G. A. (2022) · Hypertension · doi:10.1161/hypertensionaha.122.19377 · Cited by 89
Metadata
- Authors
- Schünemann, H. J., Mustafa, R. A., Brozek, J., Steingart, K. R., Leeflang, M., Murad, M. H., Bossuyt, P., Glasziou, P., Jaeschke, R., Lange, S., Meerpohl, J., Langendam, M., Hultcrantz, M., Vist, G. E., Akl, E. A., Helfand, M., Santesso, N., Hooft, L., Scholten, R., Rosen, M., Rutjes, A., Crowther, M., Muti, P., Raatz, H., Ansari, M. T., Williams, J., Kunz, R., Harris, J., Rodriguez, I. A., Kohli, M., & Guyatt, G. H.
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2020-06
- Volume
- 122
- Pages
- 129-141
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W3005727251
- Cited by
- 405
- References
- 13
- FWCI
- 28.86
- Type
- journal article
- Language
- en
- Open access
- bronze
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
How to cite
Cite CoChat for the checks on this page, and the paper for its own findings.
- This page
- CoChat. (2026). Citation check: GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy. https://app.cochat.ai/papers/10.1016/j.jclinepi.2019.12.020
- The paper
- Schünemann, H. J., Mustafa, R. A., Brozek, J., Steingart, K. R., Leeflang, M., Murad, M. H., Bossuyt, P., Glasziou, P., Jaeschke, R., Lange, S., Meerpohl, J., Langendam, M., Hultcrantz, M., Vist, G. E., Akl, E. A., Helfand, M., Santesso, N., Hooft, L., Scholten, R., . . . Guyatt, G. H. (2020). GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy. Journal of Clinical Epidemiology. https://doi.org/10.1016/j.jclinepi.2019.12.020
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.