Multicenter inter-examiner agreement trial for the validation of simplified POPQ system
ABSTRACT The primary aim of this study was to evaluate the inter-examiner agreement of a previously described simplified pelvic organ prolapse quantification (S-POP) system in a multicenter, prospective, randomized, blinded fashion. Pelvic organ prolapse quantification (POPQ) system's use in daily practice is hampered due to perceived complexity and difficulty of use. The S-POP was introduced in order to make the POPQ user-friendly and increase its usage (Swift et al. in Int Urogynecol J 17(6):615-620, 2006).
Five hundred eleven subjects underwent two separate pelvic exams in random order by two blinded examiners employing the S-POP at 12 centers around the world. Data were compared using weighted kappa statistics.
The weighted kappa statistics for the inter-examiner reliability of the S-POP were 0.87 for the overall stage, 0.89 and 0.81 for the anterior and posterior vaginal walls, 0.82 for the apex/cuff 0.89, and 0.84 for the cervix and vaginal fornix, respectively.
There is an almost perfect inter-examiner agreement of the S-POP system for the overall stage and each point within the system.
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ABSTRACT: Urinary incontinence is an important health problem to the individual sufferer and to health services. Stress and stress predominant mixed urinary incontinence are increasingly managed by surgery due to advances in surgical techniques. Despite the lack of evidence for its clinical utility, most clinicians undertake invasive urodynamic testing (IUT) to confirm a functional diagnosis of urodynamic stress incontinence before offering surgery for this condition. IUT is expensive, embarrassing and uncomfortable for women and carries a small risk. Recent systematic reviews have confirmed the lack of high quality evidence of effectiveness.The aim of this pilot study is to test the feasibility of a future definitive randomised control trial that would address whether IUT alters treatment decisions and treatment outcome in these women and would test its clinical and cost effectiveness. This is a mixed methods pragmatic multicentre feasibility pilot study with four components:-(a) A multicentre, external pilot randomised trial comparing basic clinical assessment with non-invasive tests and IUT. The outcome measures are rates of recruitment, randomisation and data completion. Data will be used to estimate sample size necessary for the definitive trial.(b) Qualitative interviews of a purposively sampled sub-set of women eligible for the pilot trial will explore willingness to participate, be randomised and their overall trial experience.(c) A national survey of clinicians to determine their views of IUT in this context, the main outcome being their willingness to randomise patients into the definitive trial.(d) Qualitative interviews of a purposively sampled group of these clinicians will explore whether and how they use IUT to inform their decisions. The pilot trial will provide evidence of feasibility and acceptability and therefore inform the decision whether to proceed to the definitive trial. Results will inform the design and conduct of the definitive trial and ensure its effectiveness in achieving its research aim. Current Controlled Trials ISRCTN71327395 assigned 7th June 2010.Trials 07/2011; 12(1):169. DOI:10.1186/1745-6215-12-169 · 1.73 Impact Factor
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ABSTRACT: This study was conducted to determine the differences in the inter-observer agreement of the simplified Pelvic Organ Prolapse Quantification (POP-Q) system from center to center in a large international multicenter study. This is a secondary analysis of the results of a large prospective single blind multicenter trial studying the inter-observer agreement of a simplified POP-Q exam. Twelve centers from four continents with a total of 511 subjects were included in this study. The number of subjects recruited per center ranged from 20 to 81. Each patient was independently examined by two investigators, with examination order randomly assigned and investigators blinded to each other's result. The weighted kappa statistic was used to evaluate the inter-observer agreement. Good and significant associations were observed on the anterior, posterior, and apical segments. Six out of 11 sites did not provide adequate number of subjects with prior hysterectomy for weighted kappa statistics or achieve significance regarding vaginal cuff measurement. The simplified POP-Q demonstrated good inter-examiner agreement across multiple centers.International Urogynecology Journal 11/2011; 23(5):579-84. DOI:10.1007/s00192-011-1593-y · 1.96 Impact Factor