The Minimum Clinically Important Difference of the International Consultation on Incontinence Questionnaires (ICIQ-UI SF and ICIQ-LUTSqol) - 06/11/19
, Men Long Liong 3, Ka Keat Lim 4, Wing Seng Leong 5, Kah Hay Yuen 1Abstract |
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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| Ethics:The study was approved by the Joint Ethics Committee of the School of Pharmaceutical Sciences, Universiti Sains Malaysia-Hospital Lam Wah Ee on Clinical Studies (USM-HLWE/IEC/2013[0006]). All participants provided written informed consent. |
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| Conflicts of Interest:This study used data from a randomized clinical trial sponsored by QRS International. Renly Lim was a PhD student who received a research allowance from QRS International during her PhD candidature. All other authors declare that they have no competing interests. |
Vol 133
P. 91-95 - novembre 2019 Retour au numéro
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