Minimal Clinically Important Difference (MCID) for the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire – IUGA Revised (PISQ-IR)

Abstract

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. Conclusion:We estimated the MCID for the PISQ-IR SA summary score to be 0.31 in our surgery group.

Patient-Reported Outcome Measures for Use in Women With Pelvic Organ Prolapse

“…62 Floor or ceiling effect was reported for only five patient-reported outcomes (the ABI, 58 ePAQ-PF, 38,53 PISQ-12, 52 PISQ-IR, 24 and SPS-Q 22 ). The minimal clinical important difference was reported for only seven patient-reported outcomes: the APFQ POP domain (minimal clinical important difference 1.0 using an a priori value and anchor-based methods), 13,15 the EQ-5 (minimal clinical important difference 0.025 through anchor and distribution based), 35 all domains of the PFDI-20 (minimal clinical important difference 13.5, 24, and 45 through anchor and distribution based), 19,39,59 PFIQ-7 (minimal clinical important difference 36 through anchor based), 19 PISQ (minimal clinical important difference 6 through anchor based), 43 PISQ-IR (minimal clinical important difference 0.3 through anchor and distribution based), 48 and SF-6 (minimal clinical important difference 0.026 through anchor and distribution based). 35 Minimal clinical important difference quality was rated as very good for all of these except the APFQ (one inadequate, one adequate) and the PISQ-IR (adequate).…”

“…17,19,23,[29][30][31]34,37,39,59,61 The PISQ had 14 total across all versions: two for the original PISQ, 2,43 seven for the PISQ-12, 12,31,40,44,45,50,52 and five for the PISQ-IR (Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised). 24,48,51,63 The PFIQ (Pelvic Floor Impact Questionnaire) had 10 total across all versions: four for the original PFIQ 1,20,40,60 and six for the PFIQ-7. 17,19,[29][30][31]34 The SF (Short Form Dimensions) had three total studies across two versions: one for the SF-12 and two for SF-6.…”

“…26 The PFBQ had one study reporting measurement properties of content or face validity, construct validity (very good), criterion validity (adequate), reliability (very good), and internal consistency (very good). 46 The PISQ-IR had five studies reporting content of face validity (two studies), 48,51 criterion validity (one study, adequate), 51 reliability (one study, very good), 51 internal consistency (one study, very good), 51 and responsiveness (three studies: two adequate, one doubtful). 24,32,51 The ePAQ-PF (Electronic Personal Assessment Questionnaire—Pelvic Floor), EPIQ (Epidemiology of Prolapse and Incontinence Questionnaire), FASS (FIGO Prolapse Assessment Scoring System), ITSQ (Integral Theory System Questionnaire), PIKQ (Prolapse and Incontinence Knowledge Questionnaire), and POP-SS (Pelvic Organ Prolapse Symptom Score) had data on four measurement properties each.…”

A literature review on vaginal dilator use

“…40 The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) is seven to twenty questions and is valid in female patients with sexual dysfunction with diagnoses of pelvic floor dysfunction in nine languages. 41 This test is validated in patients who are sexually active and not sexually active and has a cutoff score of 2.68. 42 The mean clinically important difference for this PROM is 0.31 points for each corresponding scale of 0-4.…”

“…42 The mean clinically important difference for this PROM is 0.31 points for each corresponding scale of 0-4. 41 Given the UIHC PFPT patient population, the use of the FSFI-6 would increase treatment time with patients as it is the shortest PROM. The PISQ-IR would also be a viable alternative for females with sexual disfunction as it is valid in the sexually active and non-sexually active patient populations and correlates well with the FSFI.…”