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Anogenital Distance and Perineal Measurements of the Pelvic Organ Prolapse POP Quantification System
Published on: September 20, 2018
Minimal Clinically Important Difference (MCID) for the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function
Bente Pruijssers1, Lisa van der Vaart2, Fred Milani3
1Department of Obstetrics and Gynecology, University Medical Center, Utrecht, The Netherlands.
Background:
To 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.
Aim:
To 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.
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. 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).
Outcomes:
MCID for the SA summary score of the PISQ-IR.
Results:
Data 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 Implications:
Future research on this subject should focus on clinical relevance of results rather than statistical significance only.
Strengths & Limitations:
Our 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.
Conclusion:
We estimated the MCID for the PISQ-IR SA summary score to be 0.31 in our surgery group.
Insights
The minimal clinically important difference (MCID) for the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) summary score in sexually active women undergoing surgery was determined to be 0.31. This finding helps contextualize patient-reported outcomes in clinical practice.
Area of Science:
- Urogynecology
- Sexual Health
- Clinical Outcomes Research
Background:
- Patient-reported outcome measurement (PROM) questionnaires track changes in patient health.
- The minimal clinically important difference (MCID) translates statistically significant changes into clinical relevance.
- MCID is crucial for interpreting the clinical significance of PROM data.
Purpose of the Study:
- To determine the MCID for the summary score of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR).
- To assess sexual functioning (SF) in sexually active (SA) women with symptomatic pelvic floor disorders.
- To provide clinical context for changes in PISQ-IR scores.
Main Methods:
- A multicentre prospective cohort study compared pessary therapy with surgery for symptomatic pelvic organ prolapse (POP).
- The PISQ-IR was administered at baseline and 12 months.
- Both anchor-based (using PGI-I and PISQ-IR question 19a) and distribution-based (effect size) methods were employed to calculate MCID.
Main Results:
- Data from 243 women were analyzed.
- In the surgery group, PISQ-IR question 19a met anchor criteria.
- An increase of 0.31 points in the PISQ-IR summary score corresponded to a 1-point improvement in sexual satisfaction.
Conclusions:
- The MCID for the PISQ-IR SA summary score in the surgery group was estimated at 0.31.
- This value aids in understanding the clinical importance of sexual function improvements after POP treatment.
- Future research should prioritize clinical relevance over statistical significance.
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