Why STARDaki Was Developed
A systematic review of 107 AKI biomarker studies revealed critical gaps in reporting quality, motivating the need for standardized reporting guidance.
Acute kidney injury (AKI) affects 5–12% of hospitalized patients and over 50% of ICU patients. While biomarkers offer promise for early detection, existing studies are heterogeneous and poorly reported.
We systematically reviewed 107 AKI biomarker diagnostic accuracy studies and found that on average, only 54.5% of STARD 2015 items were properly reported. Critical methodological details—such as blinding of reference standard assessors, sample size justification, and handling of indeterminate results—were frequently missing. The wide performance ranges observed across studies are not shortcomings of individual biomarkers but a predictable consequence of heterogeneous reporting.
STARD 2015 Compliance & QUADAS-2 Assessment
Systematic Review
- 13,057 articles identified across PubMed, Embase, Cochrane Library, Web of Science
- 107 studies included; 19 for descriptive analysis
- 48-hour sampling-to-diagnosis window for biomarker evaluation
- STARD 2015 and QUADAS-2 quality assessment
Delphi Consensus
- 17-member panel from 10 countries across Europe, North America, Asia
- RAND/UCLA Appropriateness Method with iterative surveys
- Round 1: mean 4.66 (AR 95%) → Round 2 confirmed: mean 4.54 (AR 94%)
- Final 30-element checklist approved by unanimous vote
Detailed supporting information—including complete search strategies, individual study quality assessments, and Delphi survey materials—is available in the supplementary materials.
