Incontinence-specific quality of life measures used in trials of treatments for female urinary incontinence: a systematic review (original) (raw)
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Quality of Life Research, 2008
Objectives To evaluate the measurement properties of the EuroQoL EQ-5D and two condition-specific patientreported outcome measures-the Symptom Severity Index (SSI) and the Urinary Incontinence-Specific Quality of Life instrument (I-QoL)-in women with urinary incontinence. Methods A questionnaire comprising all instruments was completed by women taking part in a clinical trial of physiotherapy for urinary incontinence. Follow-up questionnaires were at 6 weeks and 5 months. Data quality, internal consistency reliability, validity and responsiveness were assessed. Results One hundred and seventy-four patients taking part in the clinical trial completed the questionnaire. Instruments had low levels of missing data. The EQ-5D had a large ceiling effect and poor responsiveness. The SSI had poor validity and responsiveness. The I-QoL had levels of reliability that supported application in group assessment, and in some cases, individual assessment, and good evidence of validity. The I-QoL was the most responsive instrument at both 6 weeks and 5 months. Conclusion The I-QoL was the best performing instrument and is recommended as a continence-specific measure of quality of life in a clinical trial setting. The SSI and EQ-5D are not recommended. Alternative generic instruments, which support economic evaluation, require further evaluation in trials of female urinary incontinence.
Neurourology and Urodynamics, 2021
AimThis systematic review aims to identify disease‐specific and generic quality of life (QoL) outcome measurement instruments used in populations of women with urinary incontinence (UI) and to determine the most psychometrically robust and appropriate disease‐specific and generic tools for measuring the quality of life in this population.MethodsA systematic search was conducted of PubMed, Embase, SCIELO, and CINAHL databases for studies evaluating measurement properties of QoL instruments in women with UI. The methodological quality of studies and the quality of measurement properties were evaluated using the COnsensus‐based Standards for the selection of health status Measurement INtruments (COSMIN) checklist and quality criteria. Overall, evidence for measurement properties was graded using the modified grading of recommendations, assessment, development & evaluation approach.ResultsA total of 73 studies were included, and 27 specific and 6 generic instruments were identified. The...
Symptom severity and QOL scales for urinary incontinence
Gastroenterology, 2004
Symptoms of incontinence are common, particularly among older people, and incontinence can have a severe effect on the quality of life of some individuals at any age. A number of treatments are available, most of which aim to reduce the occurrence of incontinent episodes or to limit the effects of the disorder on everyday life. In research and clinical practice, it is essential that the symptoms and effects of incontinence be properly assessed and recorded. The only valid means of measuring patients' perspectives is through the use of psychometrically robust self-report questionnaires. Incontinence may be experienced as part of the symptom complex of a range of conditions (e.g., benign prostatic diseases or fistulas), and the effect of incontinence on quality of life varies depending on the severity of the condition and other psychosocial and medical factors. Questionnaires with acceptable levels of psychometric testing are identified and recommended for use in clinical practice and research investigations according to the following categories: (1) questionnaires to assess symptoms of incontinence, (2) generic health-related quality-of-life questionnaires to assess the effect of incontinence on quality of life, and (3) incontinence-specific measures to assess the effect and bothersomeness of incontinence on quality of life.
Urology, 2004
Objectives. To correlate the clinical and urodynamic parameters with two measures of incontinence-specific quality of life (QOL), to describe the changes in those measures after treatment, and to explore the factors determining these changes. Methods. A total of 82 incontinent women (mean age 52 years, range 28 to 80) underwent urodynamics testing and a 48-hour pad test. They also completed the frequency/volume chart, estimated the degree of bother from urinary incontinence using the visual analog scale (VAS), and completed a validated QOL instrument-the Urinary Incontinence Severity Score (UISS). Sixty-nine women were re-evaluated 13 months (range 6 to 21) after treatment. Results. A greater degree of disability from urinary incontinence as measured by the VAS correlated with a lower maximal urethral closure pressure (r ϭ Ϫ0.29, P Ͻ0.01), greater detrusor pressure (r ϭ 0.30, P Ͻ0.05), and amount of urine leakage (r ϭ 0.46, P Ͻ0.001). The UISS correlated poorly with the urodynamic and frequency/volume chart findings. A greater amount of urine leakage was the best predictor of QOL impairment as measured by the UISS (beta 0.25; P ϭ 0.034). The change in urine leakage best predicted the change in the UISS (beta 0.30; P ϭ 0.024) and the change in the VAS (beta 0.48; P ϭ 0.001). Conclusions. The response to the question "How bothered are you by incontinence at this moment?" best reflects the severity of urinary incontinence measured objectively. Urodynamic parameters correlated poorly with incontinence-specific QOL measure. Of the clinical objective measures of the severity of urinary incontinence, the amount of leakage in the pad test was the best, although modest, predictor of QOL impairment. The change in urine leakage best predicted the change in QOL scores and VAS 1 year after beginning treatment. UROLOGY 63: 67-72, 2004. © 2004
2009
Aims: To compare the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) with the Incontinence Severity Index (ISI), and to propose intervals for four severity levels of ICIQ-UI SF. Methods: Cross-sectional, Internet-based study of 1,812 women responding to a general health questionnaire. Four severity levels for the ICIQ-UI SF scores were constructed by iteratively adjusting the ranges for these levels until maximum Kappa scores were obtained when cross-tabulated with the ISI in a random sample of half of the women with urinary incontinence. Using these intervals, weighted Kappa was calculated for the remaining women as a validation process. Results: Three hundred forty-three women had urinary incontinence, and completed the ISI and the ICIQ-UI SF. A high correlation between the ISI and ICIQ-UI SF scores with versus without the QoL item was found (Spearman's rho ¼ 0.62, P < 0.01 vs. rho ¼ 0.71, P < 0.01, respectively). Maximum Kappa with quadratic weighting was obtained for the following scale for the ICIQ-UI SF: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21) (Kappa ¼ 0.61), and without the QoL item: slight (1-3), moderate (4-5), severe (6-9) and very severe (10-11) (Kappa ¼ 0.71) in the development sample. Correspondingly, for the validating sample, maximum Kappa with quadratic weighting was 0.61 and 0.74. Conclusions: A high correlation between the ICIQ-UI SF and the ISI was found. The ICIQ-UI SF may be divided into the following four severity categories: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21). Neurourol. Urodynam. 28:411-415, 2009.
Portuguese validation of the Urinary Incontinence-Specific Quality-of-Life Instrument: I-QOL
International Urogynecology Journal, 2009
Introduction and hypothesis Our objective was to translate and validate a Portuguese version of the Urinary Incontinence-Specific Quality-of-Life Instrument (I-QOL), a questionnaire that is widely used in clinical trials. Methods Fifty patients completed the same questionnaire twice at a 2-week interval. During the first visit, we conducted a face-to-face interview and collected demographic data. The King's Health Questionnaire was completed during the same visit for comparisons.
Quality of Life Research, 2005
Urinary incontinence (UI) has substantial and important impacts on health-related quality of life. The purpose of this research is to report the psychometric performance of 15 different language versions of the Incontinence-specific Quality of Life (I-QOL) measure, a patient-reported outcome measure specific to stress, urge and mixed urinary incontinence. The multi-national dataset consisted of data from four clinical trials for stress incontinent females and from two additional population studies, enrolling women with stress, urge and mixed UI. All enrolled patients completed the I-QOL and comparative measures at baseline. The clinical trial populations had multiple administrations up to 12 weeks, and the two population studies included a shorter retest. Country-specific psychometric testing for validity, reliability, and responsiveness followed standardized procedures. Confirmatory factor analyses were performed to assess the I-QOL subscales. The I-QOL measurement model was confirmed as three subscales. Summary and subscale scores for the 15 versions were internally consistent (alpha values = 0.91-0.96) and reproducible (ICC = 0.72-0.97). Using changes in the independent measures of incontinence episode frequency standardized response means were predominantly strong (ranged 0.71-1.05) across 13 versions (out of 15) in association with these measures and effect sizes. These additional language versions of the I-QOL instrument demonstrate psychometric properties similar to the original version. The I-QOL has shown good results in both community studies and clinical trials with varying types and severity of urinary incontinence. It is a reliable and valid measure of HRQOL, suitable for use in a variety of international settings.
Neurourology and Urodynamics, 2002
Aims. To evaluate two quality of life measures for urinary incontinence (UI) in Scottish females. Methods. Three groups with UI from two regions in Scotland were studied. Two groups were receiving treatment for incontinence; the third was not. Women completed the UDI and IIQ twice to allow assessment of test-retest reliability and validity. Treatment groups completed the questionnaires again, postintervention, to assess ability of the measures to detect change. Other measures used to assess validity were the SF-36, HADS, weight of urine leaked, and number of incontinence episodes. By design, the three subject groups di¡ered signi¢cantly in their characteristics, ensuring a diverse sample of women. Results. Analysis of reliability showed a clinically trivial but statistically signi¢cant decrease in total UDI (mean, À6.1; 95% CI, À11.0 to À1.5) and IIQ (mean, À9.7; 95% CI, À15.5 to À3.9) scores between test and retest assessments, possibly due to a research e¡ect. Most items of the UDI (18 of 19) and IIQ (28 of 30) performed very well on test-retest. The UDI and IIQ were valid in that higher scores (indicating more bothersomeness of symptoms/impact on daily living) were associated with greater severity of UI. Additionally the IIQ showed the expected associations with measures of anxiety and health status. Conclusions. Both the UDI and IIQ detected changes in women's conditions due to intervention. The measures had good psychometric properties, including test-retest reliability, across subject groups.
Introduction: Urinary incontinence is a common health, physical, and social problem in the world. There is an urgent need of effective questionnaires for its evaluation in Iranian women. Aim: The present study aimed to assess validity and reliability of the adapted and translated version of the Incontinence Impact Questionnaire (IIQ-7) and the Urogenital Distress Inventory (UDI-6) in the Persian language. Materials and Methods: This cross-sectional study was conducted from April to October 2015. A sample of 200 consecutive women who participated in this study filled the final version of the questionnaires. Eligible samples were divided into two groups (with and without UI). Standard forward-backward procedure was applied for translating the questionnaires into Persian. Reliability was assessed using test/retest reliability and internal consistency. In addition, validity was evaluated using face and content validity, comparison with known groups, and convergent validity. Results: Two hundred women participated in this study and filled both the questionnaires. Both the normal and incontinent groups had 100 subjects. Mean age of the respondents was 47.52±9.84 years. The content validity analysis produced favourable results. IIQ and UDI successfully discriminated the two groups. There was a significant negative correlation between the two questionnaires and all subscales of the Short Form Health Survey (SF-36). The Cronbach’s alpha coefficient for UDI-6 and IIQ-7 was 0.88 and 0.95, respectively. The Intraclass Correlations (ICC) scores for the Persian language versions were 0.96 for UDI-6 and 0.97 for IIQ-7. Conclusion: This study demonstrated that the newly developed Persian language version of IIQ-7 and UDI-6 are short, valid, and reliable methods for assessing the quality of life of women with UI.