Table 2

List of validity criteria operationalised for papers reporting on the accuracy of urine dipsticks in the diagnosis of Urinary Tract Infections (UTI) or Bacteriuria

Criteria of internal validity (IV)

Positive score

Valid reference standard

(semi-)quantitative (2 points) ot dipslide culture (1 point)

Definition of cut-off point for reference standard

definition of Urinary Tract Infection/Bacteriuria by colony forming units per ml (1 point)

Blind measurement of index test and reference test

in both directions (2 points) or only index or reference test

Avoidance of verification bias

assessment by reference standard independent from index test results (1 point)

Index test interpreted independently of all clinical information

explicitly mentioned in the publication or urine samples from mixed out-patient populations examined in a general laboratory (1 point)


prospective (consecutive series) (1 point) or retrospective collection of data (0 points)

Criteria of external validity (EV)

1 Spectrum of disease

in- and/or exclusion criteria mentioned (1 point)

2 Setting

enough information to identify setting (1 point) (community through tertiary care)

3 Previous tests/referral filter

details give about clinical and other diagnostic information as to which the index test is being evaluated (symptomatic or asymptomatic patients (1 point)

4 Duration of illness before diagnosis

duration mentioned (1 point)

5 Co-morbid conditions

details given (type of population) (1 point)

6 Demographic information

age (1 point) and/ or gender (1 point) data provided

7 Execution of index test

information about standard procedure directly or indirectly available, urine collection procedure, first voided urine, distribution of micro-organisms, procedure of contaminated urine samples, time of transportation of urine sample, way of reading index test, persons reading index test (1 point each)

8 Explicitation of cut-off point of index test

trace, 2 or more + (1 point if applicable)

9 Percentage missing

if appropriate: missings mentioned (1 point)

10 Reproducibility of index test

reproducibility studied or reference mentioned (1 point)

Blinding (IV3): When information about blinding of measurements was not given and the dipstick was performed in another setting than the culture, we assumed blind assessment of the index test versus the reference test but not vice versa. Explicitation of the cut-off point (EV8) was only necessary for the leukocyte-esterase measurement.

DevillĂ© et al. BMC Medical Research Methodology 2002 2:9   doi:10.1186/1471-2288-2-9

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