Renly Lim1, Men Long Liong2, Ka Keat Lim3, Wing Seng Leong4, Kah Hay Yuen5. 1. School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia; Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia. Electronic address: renly_lim@hotmail.com. 2. Department of Urology, Island Hospital, Penang, Malaysia. 3. Programme in Health Services and Systems Research, Duke University-National University of Singapore (Duke-NUS) Medical School, Singapore. 4. Department of Urology, Lam Wah Ee Hospital, Penang, Malaysia. 5. School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia.
Abstract
OBJECTIVE: To estimate the minimum clinically important difference (MCID) of the International Consultation on IncontinenceQuestionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) using both anchor-based and distribution-based methods for women with stress urinary incontinence undergoing nonsurgical treatment. MATERIALS AND METHODS: Data from a randomized clinical trial evaluating efficacy of a nonsurgical intervention in women with stress urinary incontinence were used for analyses. The overall score of ICIQ-UI SF ranges from 0 to 21, with greater values indicating increased severity. The ICIQ-LUTSqol ranges from 19 to 76, with greater values indicating increased impact on quality of life. Instruments used in the anchor-based method were the Patient Global Impression of Improvement, patient satisfaction, 1-hour pad test and the incontinence episode frequency. The distribution-based method used an effect size of 0.5 standard deviation. Triangulation of findings was used to converge on a single value of MCID. RESULTS: At 12-month post-treatment, 106 (88.3%) participants completed the follow-up and were included in the analysis. Anchor-based MCIDs of the ICIQ-UI SF were between 3.4 and 4.4, while the distribution-based MCID was 1.7. Anchor-based MCIDs of the ICIQ-LUTSqol were between 4.8 and 6.9, while the distribution-based MCID was 5.2. Triangulation of findings showed that MCIDs of 4 for ICIQ-UI SF and 6 for ICIQ-LUTSqol were the most appropriate. CONCLUSION: For women undergoing nonsurgical treatments for incontinence, reductions of 4 and 6 points in ICIQ-UI SF and ICIQ-LUTSqol, respectively are perceived as clinically meaningful.
RCT Entities:
OBJECTIVE: To estimate the minimum clinically important difference (MCID) of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) using both anchor-based and distribution-based methods for women with stress urinary incontinence undergoing nonsurgical treatment. MATERIALS AND METHODS: Data from a randomized clinical trial evaluating efficacy of a nonsurgical intervention in women with stress urinary incontinence were used for analyses. The overall score of ICIQ-UI SF ranges from 0 to 21, with greater values indicating increased severity. The ICIQ-LUTSqol ranges from 19 to 76, with greater values indicating increased impact on quality of life. Instruments used in the anchor-based method were the Patient Global Impression of Improvement, patient satisfaction, 1-hour pad test and the incontinence episode frequency. The distribution-based method used an effect size of 0.5 standard deviation. Triangulation of findings was used to converge on a single value of MCID. RESULTS: At 12-month post-treatment, 106 (88.3%) participants completed the follow-up and were included in the analysis. Anchor-based MCIDs of the ICIQ-UI SF were between 3.4 and 4.4, while the distribution-based MCID was 1.7. Anchor-based MCIDs of the ICIQ-LUTSqol were between 4.8 and 6.9, while the distribution-based MCID was 5.2. Triangulation of findings showed that MCIDs of 4 for ICIQ-UI SF and 6 for ICIQ-LUTSqol were the most appropriate. CONCLUSION: For women undergoing nonsurgical treatments for incontinence, reductions of 4 and 6 points in ICIQ-UI SF and ICIQ-LUTSqol, respectively are perceived as clinically meaningful.
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