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Table 1 Proportion of reporting of the items in the STARD statement, overall and in a total of 103 diagnostic studies involving rheumatoid arthritis by STARD score group

From: The reporting quality of studies investigating the diagnostic accuracy of anti-CCP antibody in rheumatoid arthritis and its impact on diagnostic estimates

STARD*items

Overall % of reporting item n = 103

% of reporting item

P-value‡

  

Lower quality articles (score < 9) n = 50

Higher quality articles (score ≥ 9) n = 53

 

METHODS

    

1. The study population: The inclusion and exclusion criteria, setting and locations where the data were collected.

88.3

78.0

98.1

0.002

2. Participant recruitment: Was recruitment based on presenting symptoms, results from previous tests, or the fact that the participants had received the index tests or the reference standard?

98.1

98.0

98.1

0.999

3. Participant sampling: Was the study population a consecutive series of participants defined by the selection criteria in item 3 and 4? If not, specify how participants were further selected.

89.3

88.0

90.6

0.756

4. Data collection: Was data collection planned before the index test and reference standard were performed (prospective study) or after (retrospective study)?

95.1

90.0

100.0

0.024

5. The reference standard and its rationale.

74.8

52.0

96.2

<0.01

6. Technical specifications of material and methods involved including how and when measurements were taken, and/or cite references for index tests and reference standard.

57.3

48.0

66.0

0.075

7. Definition of and rationale for the units, cut-offs and/or categories of the results of the index tests and the reference standard.

77.7

68.0

86.8

0.032

8. The number, training and expertise of the persons executing and reading the index tests and the reference standard.

20.4

8.0

32.1

0.003

9. Whether or not the readers of the index tests and reference standard were blind (masked) to the results of the other test and describe any other clinical information available to the readers.

18.4

12.0

24.5

0.130

10. Methods for calculating or comparing measures of diagnostic accuracy, and the statistical methods used to quantify uncertainty (e.g. 95% confidence intervals).

90.3

82.0

98.1

0.007

11. Methods for calculating test reproducibility, if done. #

88.0

100.0

86.4

0.999

RESULTS

    

12. When study was done, including beginning and ending dates of recruitment.

41.7

26.0

56.6

0.003

13. Clinical and demographic characteristics of the study population (e.g. age, sex, spectrum of presenting symptoms, comorbidity, current treatments, recruitment centers).

87.4

78.0

96.2

0.007

14. The number of participants satisfying the criteria for inclusion that did or did not undergo the index tests and/or the reference standard; describe why participants failed to receive either test (a flow diagram is strongly recommended).

12.6

2.0

22.6

0.002

15. Time interval from the index tests to the reference standard, and any treatment administered between.

27.2

12.0

41.5

0.001

16. Distribution of severity of disease (define criteria) in those with the target condition; other diagnoses in participants without the target condition.

53.4

46.0

60.4

0.169

17. A cross tabulation of the results of the index tests (including indeterminate and missing results) by the results of the reference standard; for continuous results, the distribution of the test results by the results of the reference standard.

94.2

92.0

96.2

0.428

18. Any adverse events from performing the index tests or the reference standard.

11.7

10.0

13.2

0.761

19. Estimates of diagnostic accuracy and measures of statistical uncertainty (e.g. 95% confidence intervals).

74.8

54.0

94.3

<0.01

20. How indeterminate results, missing responses and outliers of the index tests were handled.

7.8

6.0

9.4

0.716

21. Estimates of variability of diagnostic accuracy between subgroups of participants, readers or centers, if done. #

100.0

100.0

100.0

-

22. Estimates of test reproducibility, typically imprecision (as CV) at 2 or 3 concentrations, if done. #

96.0

100.0

95.5

0.999

  1. (Lower quality articles, score < 9 and higher quality articles, score ≥ 9).
  2. # for smaller number of articles (n = 25 articles for items 11 & 22), (n = 23 articles for item 21).
  3. ‡ P values were obtained from Fisher’s exact test in order to express the association between proportions for reporting an item across the two groups of articles.
  4. * STARD = Standards for Reporting of Diagnostic Accuracy.