Abstract
BackgroundTo put statistically significant changes in patient reported outcome measurement (PROM) questionnaires into a clinical perspective, the concept of the minimal clinically important difference (MCID) can be used. AimTo determine the MCID for the summary score for sexually active (SA) women of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), a validated instrument which assesses sexual functioning (SF) for patients suffering from a symptomatic pelvic floor disorder. MethodsPatients participating in a multicentre prospective cohort study comparing pessary therapy with surgery for a symptomatic pelvic organ prolapse (POP) filled in the PISQ-IR at baseline and 12 months’ follow-up. We used both an anchor-based as well as a distribution-based method to calculate the MCID for both treatment groups. The Patient Global Impression of Improvement (PGI-I) questionnaire and PISQ-IR question 19a about satisfaction with sexual functioning were used as anchors. For the distribution-based approach we used the effect size (ES). OutcomesMCID for the SA summary score of the PISQ-IR. ResultsData of 243 women were used to calculate the MCID. In the pessary group, Kendall's tau-b correlation coefficients between the PISQ-IR summary score and both anchors were below the cut-off of 0.21, which implies the anchors cannot be used to calculate an MCID. In our surgery group, the PISQ-IR question 19a met the anchor criteria and 0.31 points increase in the PISQ-IR summary score was equal to an improvement of 1 point on question 19a about satisfaction with sexual functioning. Clinical implicationsFuture research on this subject should focus on clinical relevance of results rather than statistical significance only. Strengths & LimitationsOur main strength is the fact that we used both anchor-based and distribution-based methods to determine our MCID. Secondly, we set out to determine an MCID for both treatment groups separately, which relatively enhances the generalisability of our results. A limitation is that we were not able to estimate an MCID for the pessary group.Pruijssers B, van der Vaart L, Milani F, et al. Minimal Clinically Important Difference (MCID) for the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire – IUGA Revised (PISQ-IR). J Sex Med 2021;18:1265–1270. ConclusionWe estimated the MCID for the PISQ-IR SA summary score to be 0.31 in our surgery group.
Highlights
Pelvic organ prolapse (POP) is a common condition in women, which can cause bothersome symptoms like feeling or seeing a bulge in the vagina, urinary, and/or faecal incontinence and sexual dysfunction.[1,2] Treatment success is assessed using patient reported outcome measures (PROM)
These patient reported outcome measurement (PROM) can be based on a single question reflecting reported improvement or on a validated disease specific quality of life questionnaire which covers a broader area of symptoms
One of the most important aspects of PROMs is that the potential change they measure needs to be viewed in terms of clinical relevance, and not just statistical significance
Summary
Pelvic organ prolapse (POP) is a common condition in women, which can cause bothersome symptoms like feeling or seeing a bulge in the vagina, urinary, and/or faecal incontinence and sexual dysfunction.[1,2] Treatment success is assessed using patient reported outcome measures (PROM) These PROM can be based on a single question reflecting reported improvement or on a validated disease specific quality of life questionnaire which covers a broader area of symptoms. Methods: Patients participating in a multicentre prospective cohort study comparing pessary therapy with surgery for a symptomatic pelvic organ prolapse (POP) filled in the PISQ-IR at baseline and 12 months’ follow-up We used both an anchor-based as well as a distribution-based method to calculate the MCID for both treatment groups. Conclusion: We estimated the MCID for the PISQ-IR SA summary score to be 0.31 in our surgery group
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