Development and validation of methods for assessing the quality of diagnostic accuracy studies [printed text] / P. Whiting, Author ; A.W.S. Rutjes, Author ; J. Dinnes, Author ; J.B. Reitsma, Author ; P.M.M. Bossuyt, Author ; J. Kleijnen, Author . - Winchester [United Kingdom] : National Coordinating Centre for Health Technology Assessment, 2004 . - XI, 248 p. : Ill. ; A4. ISSN : 1366-5278 : € 0,00 Languages : English ( eng)
| Descriptors: |
Classification
W 82 Biomedical technology (General)
Indexation
Diagnostic Tests Routine ; Evidence-Based Medicine ; Great Britain ; Humans ; Quality Assurance, Health Care
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| Abstract: |
OBJECTIVES:
To develop a quality assessment tool which will be used in systematic reviews to assess the quality of primary studies of diagnostic accuracy.
DATA SOURCES:
Electronic databases including MEDLINE, EMBASE, BIOSIS and the methodological databases of both CRD and the Cochrane Collaboration.
REVIEW METHODS:
Three systematic reviews were conducted to provide an evidence base for the development of the quality assessment tool. A Delphi procedure was used to develop the quality assessment tool and the information provided by the reviews was incorporated into this. A panel of nine experts in the area of diagnostic accuracy studies took part in the Delphi procedure to agree on the items to be included in the tool. Panel members were also asked to provide feedback on various other items and whether they would like to see the development of additional topic and design specific items. The Delphi procedure produced the quality assessment tool, named the QUADAS tool, which consisted of 14 items. A background document was produced describing each item included in the tool and how each of the items should be scored.
RESULTS:
The reviews produced 28 possible items for inclusion in the quality assessment tool. It was found that the sources of bias supported by the most empirical evidence were variation by clinical and demographic subgroups, disease prevalence/severity, partial verification bias, clinical review bias and observer/instrument variation. There was also some evidence of bias for the effects of distorted selection of participants, absent or inappropriate reference standard, differential verification bias and review bias. The evidence for the effects of other sources of bias was insufficient to draw conclusions. The third review found that only one item, the avoidance of review bias, was included in more than 75% of tools. Spectrum composition, population recruitment, absent or inappropriate reference standard and verification bias were each included in 50-75% of tools. Other items were included in less than 50% of tools. The second review found that the quality assessment tool should have the potential to be discussed narratively, reported in a tabular summary, used as recommendations for future research, used to conduct sensitivity or regression analyses and used as criteria for inclusion in the review or a primary analysis. This suggested that some distinction is needed between high- and low-quality studies. Component analysis was considered the best approach to incorporate quality into systematic reviews of diagnostic studies and this was taken into consideration when developing the tool.
CONCLUSIONS:
This project produced an evidence-based quality assessment tool to be used in systematic reviews of diagnostic accuracy studies. Through the various stages of the project the current lack of such a tool and the need for a systematically developed validated tool were demonstrated. Further work to validate the tool continues beyond the scope of this project. The further development of the tool by the addition of design- and topic-specific criteria is proposed. |
| Contents note: |
Glossary and list of abbreviations vii -- Executive summary xi -- 1 Background 1 -- Evaluation methods for diagnostic tests 1 -- Systematic reviews of diagnostic tests 1 -- Quality of diagnostic studies 1 -- Quality assessment tools to assess -- diagnostic studies 2 -- Assessment tool validation 2 -- Using quality assessment in diagnostic -- test reviews 2 -- STAndards for Reporting Diagnostic -- Accuracy (STARD) project 3 -- 2 Research questions 5 -- 3 Approach 7 -- 4 General methods 9 -- Classification of bias 9 -- Spectrum composition 9 -- Index test and reference standard 11 -- Interpretation 12 -- Analysis 13 -- Research planning (objective 3 only) 13 -- 5 Objective 1: Review the literature on the -- concepts underlying diagnostic research -- and identify the main factors that can bias -- the results of diagnostic studies 15 -- Methods 15 -- Results 16 -- Discussion 26 -- Conclusion 29 -- 6 Objective 2: Examine how quality assessment -- has been handled in systematic reviews 31 -- Methods 31 -- Results 32 -- Discussion 37 -- Conclusion 38 -- 7 Objective 3: Examine existing methods or -- assessment tools that have been used to -- assess the quality of diagnostic research, and -- any evidence on which they are based 39 -- Methods 39 -- Results 40 -- Discussion 46 -- Conclusions 48 -- 8 Objective 4: Develop a new evidence-based -- assessment tool for the quality assessment -- of diagnostic studies 49 -- Preliminary conceptual decisions 49 -- Item generation and assessment of item -- face validity 50 -- Delphi procedure 51 -- 9 QUADAS background document 59 -- Background to the tool 59 -- Aims of the tool 59 -- The quality assessment tool 60 -- Explanation of items included in the -- quality assessment tool and guide to -- scoring items 60 -- 10 Discussion and proposals for further -- work 67 -- Acknowledgements 69 -- References 71 -- Appendix 1 Search strategies 81 -- Appendix 2 Data extraction tables: -- objective 1 83 -- Appendix 3 Data extraction tables: -- objective 2 109 -- Appendix 4 Data extraction tables: -- objective 3 137 -- Appendix 5 Members of the advisory -- panel 185 -- Appendix 6 Delphi questionnaires 187 -- Health Technology Assessment reports -- published to date 235 -- Health Technology Assessment -- Programme 245
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| Link for e-copy: |
http://www.hta.ac.uk/fullmono/mon825.pdf |
| Format of e-copy: |
PDF [Open Access] (950 GB) |
| Record link: |
https://kce.docressources.info/index.php?lvl=notice_display&id=2596 |
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