The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews
Open accessAbstract
BACKGROUND: In the era of evidence based medicine, with systematic reviews as its cornerstone, adequate quality assessment tools should be available. There is currently a lack of a systematically developed and evaluated tool for the assessment of diagnostic accuracy studies. The aim of this project was to combine empirical evidence and expert opinion in a formal consensus method to develop a tool to be used in systematic reviews to assess the quality of primary studies of diagnostic accuracy. METHODS: We conducted a Delphi procedure to develop the quality assessment tool by refining an initial list of items. Members of the Delphi panel were experts in the area of diagnostic research. The results of three previously conducted reviews of the diagnostic literature were used to generate a list of potential items for inclusion in the tool and to provide an evidence base upon which to develop the tool. RESULTS: A total of nine experts in the field of diagnostics took part in the Delphi procedure. The Delphi procedure consisted of four rounds, after which agreement was reached on the items to be included in the tool which we have called 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 the items 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.
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According to QUADAS guidelines, samples should be collected at a consistent phase of the cycle and results should be corrected for the cycle phases.
“Firstly, according to QUADAS (Quality Assessment of Diagnostic Accuracy Studies) guidelines [15,16], samples should be collected at a consistent phase of the cycle and results should be corrected for the cycle phases.”
From A high sensitivity assay is more accurate than a classical assay for the measurement of plasma CRP levels in endometriosis (2011) · cites this paper as [16]
The Results section’s Users’ guide to QUADAS discusses the timing of an index test relative to a reference standard, not collection at a consistent cycle phase. Searches for cycle-phase sampling and adjustment found no passage in our copy recommending either practice. (LLM, conf=0.74)
Experimental — accuracy not yet measuredSamples were collected at a well defined phase of the cycle and results were corrected for cycle phase, as recommended by the QUADAS guidelines.
“In our study, samples were collected at a well defined phase of the cycle and results were corrected for cycle phase, as recommended by the QUADAS (Quality Assessment of Diagnostic Accuracy Studies) guidelines [15,16].”
From A high sensitivity assay is more accurate than a classical assay for the measurement of plasma CRP levels in endometriosis (2011) · cites this paper as [16]
The QUADAS tool (Results, Table 2) asks whether the interval between an index test and a reference standard is short enough to avoid a change in the target condition. The Users’ guide discusses that timing issue, but the passages found for cycle phase and adjustment do not address collecting samples at a defined cycle phase or correcting results for it. Our copy therefore does not verify the specific recommendation attributed to QUADAS. (LLM, conf=0.76)
Experimental — accuracy not yet measuredThe quality of initially chosen studies was assessed using the QUADAS checklist.
“The quality of the initially chosen studies was assessed and analyzed to support the inclusion / exclusion process. The used critical appraisal tool was a quality assessment of diagnostic accuracy studies (QUADAS) checklist.”
From Interoperability of heterogeneous health information systems: a systematic literature review (2023) · cites this paper as [12]
Accepted guidelines are available to appraise the methodological quality of clinical trials (e.g., Delphi List [9]) or diagnostic studies (QUADAS [10]).
“Accepted guidelines are available to appraise the methodological quality of clinical trials (e.g., Delphi List [9]) or diagnostic studies (QUADAS [10]).”
From Evaluation of the methodological quality of systematic reviews of health status measurement instruments (2009) · cites this paper as [10]
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- Whiting P Rutjes A Dinnes J Reitsma JB Bossuyt P Kleijnen J A systematic review of existing quality assessment tools used to assess the quality of diagnostic research submitted
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- Authors
- Whiting, P., Rutjes, A. W., Reitsma, J. B., Bossuyt, P. M., & Kleijnen, J.
- Affiliations
- University of York (GB)
- Amsterdam UMC Location University of Amsterdam (NL)
- Corresponding author
- Whiting, Penny
- Venue
- BMC Medical Research Methodology
- Published
- 2003-11-10
- Volume
- 3
- Issue
- 1
- Pages
- 25-25
- ISSN
- 1471-2288 (ISSN-L)
- PMC
- PMC305345
- OpenAlex
- W2147493587
- Cited by
- 3,592
- References
- 15
- Citations by year
- 2026: 40 · 2025: 69 · 2024: 102 · 2023: 81 · 2022: 109 · 2021: 123 · 2020: 146 · 2019: 127 · 2018: 183 · 2017: 202 · 2016: 202 · 2015: 281 · 2014: 289 · 2013: 337 · 2012: 338
- FWCI
- 11.13
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Medical Research Methodology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, other-oa)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
- Bristol Research (University of Bristol) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Funders
- Health Technology Assessment Programme
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Keywords
- QUADAS, quality assessment tools, diagnostic accuracy studies, systematic reviews, Delphi consensus, verification bias, review bias, reference materials, study withdrawal, indeterminate results, test execution
- MeSH terms
- Diagnosis, Humans, Quality Control, Surveys and Questionnaires, Reference Standards, Review Literature as Topic, Reproducibility of Results, Bias, Evidence-Based Medicine
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.
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