The DOI matches its Crossref record; 15 of the 15 references it cites were found in a registry or an index.
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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“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]
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In the citing paper
“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]
Experimental — accuracy not yet measuredThe check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“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]
Experimental — accuracy not yet measuredIn the citing paper
“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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Citations
Cites
Assessing the quality of reports of randomized clinical trials: Is blinding necessary?
Jadad, A. R., Moore, R. A., Carroll, D., Jenkinson, C., Reynolds, D. J. M., Gavaghan, D. J., & McQuay, H. J. (1996) · Controlled Clinical Trials · doi:10.1016/0197-2456(95)00134-4 · Cited by 17,582
Zhang, Q., Wang, C., Zheng, M., Li, Y., Li, J., Zhang, L., Shang, X., & Yan, C. (2014) · Cerebrovascular Diseases · doi:10.1159/000369778 · Cited by 11,609
Health Measurement Scales: A Practical Guide to Their Development and Use
Streiner, D. L., Norman, G. R., & Cairney, J. (1989) · Cited by 9,595
Schulz (1995) · doi:10.1001/jama.1995.03520290060030 · Cited by 5,634
Dong, Y., Hao, L., Shi, Z., Wang, G., Zhang, Z., & Han, C. (2013) · Urologia Internationalis · doi:10.1159/000351405 · Cited by 4,557
Assessing the quality of controlled clinical trials
Jüni, P., Altman, D. G., & Egger, M. (2001) · BMJ · doi:10.1136/bmj.323.7303.42 · Cited by 3,309
The Hazards of Scoring the Quality of Clinical Trials for Meta-analysis
Jüni, P. (1999) · JAMA · doi:10.1001/jama.282.11.1054 · Cited by 1,981
Systematic Reviews in Health Care: Meta‐analysis in Context
Pittler, M. (2010) · Focus on Alternative and Complementary Therapies · doi:10.1111/j.2042-7166.2002.tb05479.x · Cited by 1,639
Systematic Reviews in Health Care. Meta-analysis in Context.
Kleijnen, J., & Antes, G. (2002) · International Journal of Epidemiology · doi:10.1093/ije/31.3.697 · Cited by 1,374
Self-citationSystematic reviews of evaluations of diagnostic and screening tests
Deeks, J. J. (2001) · BMJ · doi:10.1136/bmj.323.7305.157 · Cited by 1,345
Research works printed but not linked: 3
- 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
- Whiting P, Dinnes J, Rutjes AWS, Reitsma JB, M BP, Kleijnen J: A systematic review of how quality assessment has been handled in systematic reviews of diagnostic tests. submitted
- Kerr M: The Delphi Process. The Delphi Process 2002. 2001, City: Remote and Rural Areas Research Initiative, NHS in Scotland, avaliable online at http://www.rararibids.org.uk/documents/bid79-delphi.htm
Cited by
Sorted by citations
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-citationShea, B. J., Reeves, B. C., Wells, G., Thuku, M., Hamel, C., Moran, J., Moher, D., Tugwell, P., Welch, V., Kristjansson, E., et al. (2017) · BMJ · doi:10.1136/bmj.j4008 · Cited by 10,636
SYRCLE’s risk of bias tool for animal studies
Hooijmans, C. R., Rovers, M. M., de Vries, R. B., Leenaars, M., Ritskes-Hoitinga, M., & Langendam, M. W. (2014) · BMC Medical Research Methodology · doi:10.1186/1471-2288-14-43 · Cited by 4,415
ROBIS: A new tool to assess risk of bias in systematic reviews was developed
Whiting, P., Savović, J., Higgins, J. P. T., Caldwell, D. M., Reeves, B. C., Shea, B., Davies, P., Kleijnen, J., & Churchill, R. (2016) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2015.06.005 · Cited by 2,272
Self-citationZeng, X., Zhang, Y., Kwong, J. S. W., Zhang, C., Li, S., Sun, F., Niu, Y., & Du, L. (2015) · Journal of Evidence-Based Medicine · doi:10.1111/jebm.12141 · Cited by 2,082
Metadata
- 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
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