DIAGNOSTIC ACCURACY STUDIES
The development and validation of methods for assessing the quality and reporting of diagnostic studies
Background
This project aimed to review the literature on the concepts underlying diagnostic research and identify the main factors that can bias the results of diagnostic studies. An examination of how quality assessment has been used in systematic reviews and the existing methods or assessment tools that have been used to assess the quality of diagnostic research, together with any evidence on which they are based was undertaken. A new evidence-based assessment tool for the quality assessment of diagnostic studies was then developed and its reliability and validity was tested by examining the impact of 'low' versus 'high' quality studies on the results of meta-analyses of diagnostic studies.Findings
The 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.
Conducted by: P Whiting1, AWS Rutjes2, J Dinnes3, JB Reitsma2, PMM Bossuyt2, J Kleijnen11. Centre for Reviews and Dissemination; 2. Department of Clinical Epidemiology and Biostatistics, Academic Medical Centre, University of Amsterdam; 3. Wessex Institute for Health Research and Development, University of Southampton
Further details
Project page on HTA Programme websitePublications
Westwood ME, Whiting PF, Kleijnen J. How does study quality affect the results of a diagnostic meta-analysis? BMC Med Res Methodol. 2005;5(1):20
Whiting P, Harbord R, Kleijnen J. No role for quality scores in systematic reviews of diagnostic accuracy studies. BMC Med Res Methodol. 2005; 5:19
Whiting P, Rutjes AWS, Dinnes J, Reitsma JB, Bossuyt PMM, Kleijnen J. Development and validation of methods for assessing the quality of diagnostic accuracy studies. Health Technol Assess. 2004;8(25):1-264
Wilby J, Kainth A, Hawkins N, Epstein D, McIntosh H, McDaid C, Mason A, Golder S, O'Meara S, Sculpher M, Drummond M, Forbes C. A rapid and systematic review of the clinical effectiveness, tolerability and cost effectiveness of newer drugs for epilepsy in adults. Health Technol Assess. 2005;9(15):1-172
Whiting P, Rutjes AWS, Reitsma JB, Bossuyt PMM, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol. 2003;3(1):25
Whiting P, Rutjes AWS, Reitsma JB, Glas AS , Bossuyt PMM, Kleijnen J. Sources of variation and bias in studies of diagnostic accuracy: a systematic review. Ann Intern Med. 2004;140(3):189-202
Whiting PF, Westwood ME, Rutjes AWS, Reitsma JB, Bossuyt PMM, Kleijnen J. Evaluation of QUADAS, a tool for the quality assessment of diagnostic accuracy studies. BMC Med Res Methodol. 2006;6:9Presentations
Glanville J. Finding non-RCT evidence - quality of life studies, diagnostic tests. 2nd InterTASC Workshop; 2002 May; London, UK
Glanville J. Outline of recent research into search filters to identify diagnostic tests]. Health Technology Assessment International (HTAi) Annual Meeting; 2007 June; Barcelona, Spain
Glanville J. Searching for studies for reviews of diagnostic test accuracy - which databases, which filters? 12th Annual Meeting of the UK and Ireland Contributors to the Cochrane Collaboration; 2007 March; Oxford, UK
Glanville J, Ritchie G, Lefebvre C. Do published search filters to identify diagnostic test accuracy studies perform adequately? Health Technology Assessment International (HTAi) Annual Meeting; 2007 June; Barcelona, Spain
Glanville J, Whiting P, Sterne J, Westwood M, Burke M. Which databases should we search to identify diagnostic test accuracy studies? Health Technology Assessment International (HTAi) Annual Meeting; 2007 June; Barcelona, Spain
Rutjes A, Whiting P, Reitsma J, Vlassov V. Quality assessment of studies of diagnostic accuracy included in systematic reviews. 12th Cochrane Colloquium; 2004 October; Ottawa, Canada
Westwood M, Whiting P, Cooper J, Kleijnen J. Using the QUADAS tool in the conduct of systematic reviews of diagnostic tests. 11th Cochrane Colloquium; 2003 October; Barcelona, Spain
Whiting P, Gupta R, Burch J, Kleijnen J, Marson A, Forbes C. What to do with non 2x2 data from a diagnostic systematic review? An example from a review on identifying the seizure focus in patients with epilepsy. 12th Cochrane Colloquium; 2004 October; Ottawa, Canada
Whiting P, Kleijnen J. Scoring the quality of diagnostic accuracy studies: an example using QUADAS. 12th Cochrane Colloquium; 2004 October; Ottawa, Canada
Whiting P, Rutjes A, Reitsma J, Bossuyt P, Kleijnen J. QUADAS: the development of a new tool for the quality assessment of diagnostic accuracy studies. 11th Cochrane Colloquium; 2003 October; Barcelona, Spain
Whiting P, Rutjes A, Reitsma H, Bossuyt P, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. Health Technology Assessment International (HTAi) Annual Meeting; 2004 June; Krakow, Poland
Whiting P, Westwood M, Burke M, Sterne J, Glanville J. Is it necessary to search a wide range of databases to identify diagnostic test accuracy studies? 14th Cochrane Colloquium; 2006 October; Dublin, IrelandFunding
Commissioned by the HTA Programme