Table 2: Risk of bias assessment of included studies using the QUADAS-2 tool.

Study

Patient Selection

Index Test (UPCR)

Reference Standard (24-hr urine)

Flow and Timing

Overall Risk

Substantiation from original study/ rationale

Durnwald & Mercer, 2003[12]

Low

Unclear

Low

Low

Moderate

Prospective design with defined inclusion/exclusion criteria (excluded chronic HTN, renal disease). UPCR obtained before 24-hour urine. Blinding not reported (unclear index text bias).

Leanos-Miranda, et al. 2007 [13]

Low

Low

Low

Low

Low

Large cross-sectional study (>1,000) with clearly defined population and standardized testing. Random urine collected before/after 24-hr collection and physicians blinded to results.

Saikul, et al. 2006 [14]

Unclear

Low

Low

High

High

Clear diagnostic test design with gold standard (>300 mg/24 hr). However, patients excluded for incomplete 24-hr urine collection, introducing flow bias.

Kumari, et al. 2006 [15]

Low

Unclear

Low

Low

Moderate

400 consecutive patients which creates a low selection bias. Prospective design with standardized UPCR cutoff (0.3). Blinding not reported (unclear index text bias).

Saudan, et al. 2005 [16]

Unclear

Unclear

Low

Unclear

Moderate

Uses accepted gold standard (24-hr urine), but limited reporting of enrollment, timing, and blinding.