Evaluating measurement variability in clinical investigations: the case of ultrasonic estimation of urinary bladder volume. 1997

K S Khan, and P F Chien, and M R Honest, and G R Norman
Department of Obstetrics and Gynaecology, Ninewells Hospital, Dundee, Scotland, UK.

OBJECTIVE To evaluate the quality of studies seeking to establish measurement properties (reliability and validity) of ultrasonic estimation of urinary bladder volume. METHODS Online searching of the MEDLINE database between 1966 and 1995, and scanning of bibliography of known studies on ultrasonic bladder volume estimation. Study selection and study quality assessment were performed independently by two reviewers. Each article was evaluated for suitability of the reference standard, adequacy of reported blinding of the observers and appropriateness of the statistical index of concordance. The last two of these guidelines were applied to reliability studies (evaluating the relation among observed ultrasonic estimations), and all three guidelines were applied to validity studies (evaluating the relation of ultrasonic estimation with a definitive measurement). METHODS One hundred and twenty-five participants enrolled in the five reliability studies and 769 participants in the 27 validity studies selected for appraisal of their quality. METHODS Rate of study compliance with preset criteria for high quality. RESULTS None of the studies complied with all of the criteria for high methodologic quality. In the five reliability studies, investigators did not report adequate blinding of observers in three (60%) and an appropriate index of reliability was not used in any. Among the 27 validity studies, there was a lack of a suitable reference standard in 6 (22%), an inadequate blinding in 25 (93%), and an inappropriate index of validity in all (100%). CONCLUSIONS Based on our guidelines for quality assessment, a large proportion of studies on measurement properties was found to have inadequate methods, raising concern about the credibility of the reliability and validity estimates reported. These deficiencies highlight the lack of rigour employed in the design, conduct and analysis of reliability and validity studies, which has the potential for leading to patient mismanagement due to biases in the assessment of measurement variability in clinical investigations.

UI MeSH Term Description Entries
D012016 Reference Values The range or frequency distribution of a measurement in a population (of organisms, organs or things) that has not been selected for the presence of disease or abnormality. Normal Range,Normal Values,Reference Ranges,Normal Ranges,Normal Value,Range, Normal,Range, Reference,Ranges, Normal,Ranges, Reference,Reference Range,Reference Value,Value, Normal,Value, Reference,Values, Normal,Values, Reference
D001743 Urinary Bladder A musculomembranous sac along the URINARY TRACT. URINE flows from the KIDNEYS into the bladder via the ureters (URETER), and is held there until URINATION. Bladder,Bladder Detrusor Muscle,Detrusor Urinae,Bladder Detrusor Muscles,Bladder, Urinary,Detrusor Muscle, Bladder,Detrusor Muscles, Bladder
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012680 Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) Specificity,Sensitivity,Specificity and Sensitivity
D014463 Ultrasonography The visualization of deep structures of the body by recording the reflections or echoes of ultrasonic pulses directed into the tissues. Use of ultrasound for imaging or diagnostic purposes employs frequencies ranging from 1.6 to 10 megahertz. Echography,Echotomography,Echotomography, Computer,Sonography, Medical,Tomography, Ultrasonic,Ultrasonic Diagnosis,Ultrasonic Imaging,Ultrasonographic Imaging,Computer Echotomography,Diagnosis, Ultrasonic,Diagnostic Ultrasound,Ultrasonic Tomography,Ultrasound Imaging,Diagnoses, Ultrasonic,Diagnostic Ultrasounds,Imaging, Ultrasonic,Imaging, Ultrasonographic,Imaging, Ultrasound,Imagings, Ultrasonographic,Imagings, Ultrasound,Medical Sonography,Ultrasonic Diagnoses,Ultrasonographic Imagings,Ultrasound, Diagnostic,Ultrasounds, Diagnostic

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