Abstract
BackgroundIn January 2003, STAndards for the Reporting of Diagnostic accuracy studies (STARD) were published in a number of journals, to improve the quality of reporting in diagnostic accuracy studies. We designed a study to investigate the inter-assessment reproducibility, and intra- and inter-observer reproducibility of the items in the STARD statement.MethodsThirty-two diagnostic accuracy studies published in 2000 in medical journals with an impact factor of at least 4 were included. Two reviewers independently evaluated the quality of reporting of these studies using the 25 items of the STARD statement. A consensus evaluation was obtained by discussing and resolving disagreements between reviewers. Almost two years later, the same studies were evaluated by the same reviewers. For each item, percentages agreement and Cohen's kappa between first and second consensus assessments (inter-assessment) were calculated. Intraclass Correlation coefficients (ICC) were calculated to evaluate its reliability.ResultsThe overall inter-assessment agreement for all items of the STARD statement was 85% (Cohen's kappa 0.70) and varied from 63% to 100% for individual items. The largest differences between the two assessments were found for the reporting of the rationale of the reference standard (kappa 0.37), number of included participants that underwent tests (kappa 0.28), distribution of the severity of the disease (kappa 0.23), a cross tabulation of the results of the index test by the results of the reference standard (kappa 0.33) and how indeterminate results, missing data and outliers were handled (kappa 0.25). Within and between reviewers, also large differences were observed for these items. The inter-assessment reliability of the STARD checklist was satisfactory (ICC = 0.79 [95% CI: 0.62 to 0.89]).ConclusionAlthough the overall reproducibility of the quality of reporting on diagnostic accuracy studies using the STARD statement was found to be good, substantial disagreements were found for specific items. These disagreements were not so much caused by differences in interpretation of the items by the reviewers but rather by difficulties in assessing the reporting of these items due to lack of clarity within the articles. Including a flow diagram in all reports on diagnostic accuracy studies would be very helpful in reducing confusion between readers and among reviewers.
Highlights
Introduction[1,3,4,5,6,7] To remedy this, guidelines have been developed to improve the reporting of randomised controlled trials (CONSORT), diagnostics accuracy studies (STARD), systematic reviews of randomised controlled trials (QUOROM) and observational studies (MOOSE)
State the research questions or study aims, such as estimating diagnostic accuracy 27 (84) 31 (97)0.30 or comparing accuracy between tests or across participant groups.The study population: The inclusion and exclusion criteria, setting and locations 17 (53) 10 (31)0.57 where data were collected.NA from previous tests, or the fact that the participants had received the index tests or the reference standard?Participant sampling: Was the study population a consecutive series of participants 20 (63) 25 (78)0.64 defined by the selection criteria in item 3 and 4? If not, specify how participants were further selected
After the publication of the CONSORT statement in 1996, Moher et al evaluated the quality of reporting in 211 randomised controlled trails published in British Medical Journal, the Journal of the American Medical Association, the Lancet, and the New England Journal of Medicine by using the CONSORT checklist
Summary
[1,3,4,5,6,7] To remedy this, guidelines have been developed to improve the reporting of randomised controlled trials (CONSORT), diagnostics accuracy studies (STARD), systematic reviews of randomised controlled trials (QUOROM) and observational studies (MOOSE). We have evaluated the quality of reporting of 124 diagnostic accuracy studies published in 2000 (PreSTARD evaluation) in 12 medical journals, using the items of the STARD statement. In order to evaluate the improvement of the quality of reporting of diagnostic accuracy studies published after the STARD statement, knowledge of the reproducibility of the assessment of the STARD checklist is needed. Our objective was to investigate the interassessment reproducibility of evaluating the quality of reporting of diagnostic accuracy studies published in 2000, using the items of the STARD statement. The intra- and inter-observer reproducibility was calculated to gain more insight into the sources of variation
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