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Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women.

ABSTRACT: Missing data is frequently observed in clinical trials; high rates of missing data may jeopardize trial outcome validity.We determined the rates of missing data over time, by type of data collected and compared demographic and clinical factors associated with missing data among women who participated in two large randomized clinical trials of surgery for stress urinary incontinence, the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Sling (TOMUS).The proportions of subjects who attended and missed each follow-up visit were calculated. The chi-squared test, Fisher's exact test and t test were used to compare women with and without missing data, as well as the completeness of the data for each component of the composite primary outcome.Data completeness for the primary outcome computation in the TOMUS trial (62.3%) was nearly double that in the SISTEr trial (35.7%). The follow-up visit attendance rate decreased over time. A higher proportion of subjects attended all follow-up visits in the TOMUS trial and overall there were fewer missing data for the period that included the primary outcome assessment at 12 months. The highest levels of complete data for the composite outcome variables were for the symptoms questionnaire (SISTEr 100 %, TOMUS 99.8%) and the urinary stress test (SISTEr 96.1%, TOMUS 96.7%). In both studies, the pad test was associated with the lowest levels of complete data (SISTEr 85.1%, TOMUS 88.3%) and approximately one in ten subjects had incomplete voiding diaries at the time of primary outcome assessment. Generally, in both studies, a higher proportion of younger subjects had missing data. This analysis lacked a patient perspective as to the reasons for missing data that could have provided additional information on subject burden, motivations for adherence and study design. In addition, we were unable to compare the effects of the different primary outcome assessment time-points in an identically designed trial.Missing visits and data increased with time. Questionnaire data and physical outcome data (urinary stress test) that could be assessed during a visit were least prone to missing data, whereas data for variables that required subject effort while away from the research team (pad test, voiding diary) were more likely to be missing. Older subjects were more likely to provide complete data.

SUBMITTER: Brubaker L

PROVIDER: S-EPMC4506720 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women.

Brubaker Linda L Litman Heather J HJ Kim Hae-Young HY Zimmern Philippe P Dyer Keisha K Kusek John W JW Richter Holly E HE Stoddard Anne A

International urogynecology journal 20150324 8

<h4>Introduction and hypothesis</h4>Missing data is frequently observed in clinical trials; high rates of missing data may jeopardize trial outcome validity.<h4>Purpose</h4>We determined the rates of missing data over time, by type of data collected and compared demographic and clinical factors associated with missing data among women who participated in two large randomized clinical trials of surgery for stress urinary incontinence, the Stress Incontinence Surgical Treatment Efficacy Trial (SIS ...[more]

PMID: 25800900

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Project description:ObjectivesTo compare the effectiveness and safety of surgical interventions for women with stress urinary incontinence.DesignSystematic review and network meta-analysis.Eligibility criteria for selecting studiesRandomised controlled trials evaluating surgical interventions for the treatment of stress urinary incontinence in women.MethodsIdentification of relevant randomised controlled trials from Cochrane reviews and the Cochrane Incontinence Specialised Register (searched May 2017), which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Medline In-Process, Medline Epub Ahead of Print, CINAHL, ClinicalTrials.gov, and WHO ICTRP. The reference lists of relevant articles were also searched. Primary outcomes were "cure" and "improvement" at 12 months, analysed by means of network meta-analyses, with results presented as the surface under the cumulative ranking curve (SUCRA). Adverse events were analysed using pairwise meta-analyses. Risk of bias was assessed using the Cochrane risk of bias tool. The quality of evidence for network meta-analysis was assessed using the GRADE approach.Results175 randomised controlled trials assessing a total of 21?598 women were included. Most studies had high or unclear risk across all risk of bias domains. Network meta-analyses were based on data from 105 trials that reported cure and 120 trials that reported improvement of incontinence symptoms. Results showed that the interventions with highest cure rates were traditional sling, retropubic midurethral sling (MUS), open colposuspension, and transobturator MUS, with rankings of 89.4%, 89.1%, 76.7%, and 64.1%, respectively. Compared with retropubic MUS, the odds ratio of cure for traditional sling was 1.06 (95% credible interval 0.62 to 1.85), for open colposuspension was 0.85 (0.54 to 1.33), and for transobtrurator MUS was 0.74 (0.59 to 0.92). Women were also more likely to experience an improvement in their incontinence symptoms after receiving retropubic MUS or transobturator MUS compared with other surgical procedures. In particular, compared with retropubic MUS, the odds ratio of improvement for transobturator MUS was 0.76 (95% credible interval 0.59 to 0.98), for traditional sling was 0.69 (0.39 to 1.26), and for open colposuspension was 0.65 (0.41 to 1.02). Quality of evidence was moderate for retropubic MUS versus transobturator MUS and low or very low for retropubic MUS versus the other two interventions. Data on adverse events were available mainly for mesh procedures, indicating a higher rate of repeat surgery and groin pain but a lower rate of suprapubic pain, vascular complications, bladder or urethral perforation, and voiding difficulties after transobturator MUS compared with retropubic MUS. Data on adverse events for non-MUS procedures were sparse and showed wide confidence intervals. Long term data were limited.ConclusionsRetropubic MUS, transobturator MUS, traditional sling, and open colposuspension are more effective than other procedures for stress urinary incontinence in the short to medium term. Data on long term effectiveness and adverse events are, however, limited, especially around the comparative adverse events profiles of MUS and non-MUS procedures. A better understanding of complications after surgery for stress urinary incontinence is imperative.Systematic review registrationPROSPERO CRD42016049339.

Project description:BackgroundSurgical interventions for the treatment of stress urinary incontinence (SUI) in women are commonly employed following the failure of minimally invasive therapies. Due to the limited information available on the relative cost-effectiveness of available surgeries for treating SUI, a de novo economic analysis was conducted to assess costs and effects of all relevant surgeries. To inform the economic analysis, the objective of this review was to identify and assess the quality of existing economic evaluation studies on different surgical interventions for the treatment of SUI in women.MethodsThe following databases were searched during the review process: Medical Literature Analysis and Retrieval System Online (MEDLINE), MEDLINE In-Process, Excerpta Medica Database (Embase), National Health Service Economic Evaluation Database (NHS EED), and Health Management Information Consortium and Cost-Effectiveness Analysis Registry (CEA registry). The key criteria for inclusion were that the study population included women with SUI and that the surgical interventions considered were utilised as either a primary or a follow-up surgery. The review included only full economic evaluations. Studies were quality assessed using the Drummond checklist for economic evaluations. No quantitative synthesis of the results by meta-analysis was conducted due to the high methodological heterogeneity.ResultsTwenty-six economic evaluations were included, of which 13 were model-based analyses. Surgical treatments assessed most frequently were mid-urethral slings and open and laparoscopic colposuspension. There were some differences in the methodological approaches taken, including differences in type of economic analysis, perspective, time horizon, types of resource use, and costs and outcomes that were included in the analysis. The majority of studies conducted a cost-utility analysis from a health system perspective and applied a time horizon of between 1 and 5 years. The cost-effectiveness results suggest that single-incision mini-sling and mid-urethral slings are among the most cost-effective options.ConclusionsThe review has shown that methods used for the economic evaluation of surgical treatments for SUI vary widely in terms of study design, analysis type, compared alternatives, time horizon, costing methodologies and effect outcomes. Future economic evaluation studies on surgical treatments for SUI may be improved by the application of available guidelines.Systematic review registrationRegistered in PROSPERO in 2016, CRD42016049339.

Project description:BackgroundEpidemiological studies on urinary incontinence that used a validated international standard questionnaire are limited in Japan, and few studies have examined the sociodemographic and behavioral correlates of urinary incontinence.ObjectiveThe aim of this study was to estimate the prevalence of urinary incontinence according to the Japanese version of the International Consultation on Incontinence Questionnaire-Short Form, and its sociodemographic and behavioral correlates among Japanese women.DesignA web-based cross-sectional study.MethodsA randomly sampled cross-sectional Internet survey was conducted in Japan among 3030 women aged 20-64 years. The International Consultation on Incontinence Questionnaire-Short Form score, sociodemographic, body mass index, medical and childbirth history, practice of pelvic floor muscle training, and medical care use were obtained. Descriptive statistics, the chi-square test, and forced-entry logistic regression analysis were used in data analysis.ResultsParticipants' average age was 43.4 years, and the response rate was 32.9%. The prevalence of urinary incontinence was 25.5%, and it increased with age. Stress urinary incontinence was the most common subtype (57.4%), followed by urge urinary incontinence (20.3%) and mixed urinary incontinence (16.7%). Less than 5% of those with urinary incontinence had experience with pelvic floor muscle training and medical care use. Middle-aged and older (p < 0.001), overweight and obesity (p < 0.001), vaginal delivery status (p < 0.001), low back pain (p = 0.008), and previous pelvic floor muscle training engagement (p < 0.001) were significantly associated with urinary incontinence.ConclusionIncreasing population awareness of urinary incontinence from an early age and developing effective interventions for the identified at-risk groups, such as the middle-aged and older, those with overweight and obesity, and those with previous pregnancies, are urgently needed.

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Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women.

Publications

Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women.

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