TABLE 5.

Quality of IL-6 accuracy studies for diagnosing early-onset neonatal sepsis from 1990 to 2020 according to the STARD criteria (Standards of Reporting Diagnostic Accuracy Studies).

Quality of reporting of IL-6 accuracy studies for diagnosing early-onset neonatal infection
Category and item no.	YES	NO
Methods—participants
Describe the study population:
1A. The inclusion and exclusion criteria	22	9
1B. Setting, and locations where data were collected	31	0
Describe participant recruitment:
2A. Was enrollment of patients based only on clinical signs suggesting infection?	9	22
2B. Were such patients consecutively enrolled?	2	7
2C. Was enrollment of patients based only on maternal risk factors for infection?	7	24
2D. Were such patients consecutively enrolled?	3	4
2E. Were patients identified by searching hospital records?	2	29
2F. Did the study include both patients already diagnosed with sepsis and participants in whom sepsis had been excluded?	3	28
Describe data collection:
3. Was data collection planned before the index test and reference standard were performed (prospective study)?	15	16
Test methods
Methods pertaining to the reference standard and the index test:
4A. Was a composite reference standard used to identify all newborns with sepsis, and verify index test results in infected babies?	29	2
4B. Was a reference standard used to exclude sepsis?	14	17
4C. Was a composite reference standard used to identify all newborns without sepsis, and verify index test results in uninfected babies?	3	11
4D. Did the index test or its comparator form part of the reference standard?	10	21
5. Were categories of results of the index test (including cutoffs) and the reference standard defined after obtaining results?	29	2
6. Did the study report the number, training, and expertise of the persons executing and reading the index tests and the reference standard?	7	24
7. Was there blinding to results of the index test and the reference standard?	11	20
Statistical methods
8. Describe the statistical methods used to quantify uncertainty (i.e., 95% confidence intervals)?	5	26
9. Describe methods for calculating test reproducibility	14	17
Results—participants and test results
10A. Describe when the study was done, including beginning and ending dates of recruitment	28	3
10B. Did the study report clinical and demographic (postnatal hours or days, gestational age, birth weight, gender) features in those with and without sepsis?	22	9
10C. Did the study report distribution of illness severity scores in those with and without sepsis?	3	28
11. Report the number of participants satisfying the criteria for inclusion that did or did not undergo the index tests and/or or the reference standard; describe why participants failed to receive either test.	11	20
12. Report a cross-tabulation of the results (including indeterminate and missing results) by the results of the reference standard; for continuous results report the distribution of the test results by the results of the reference standard	23	8
Results—estimates
13. Report measures of statistical uncertainty (i.e., 95% confidence intervals)	5	26
14. Report how indeterminate results, missing responses and outliers of index tests were handled	8	23
15. Report estimates of test reproducibility	14	17