Minimal important difference and patient acceptable symptom state for PFDI-20 and POPDI-6 in POP surgery

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ORIGINAL ARTICLE

Minimal important difference and patient acceptable symptom state for PFDI-20 and POPDI-6 in POP surgery Päivi K. Karjalainen 1,2

&

Nina K. Mattsson 2,3 & Jyrki T. Jalkanen 4,5 & Kari Nieminen 5,6 & Anna-Maija Tolppanen 7

Received: 14 July 2020 / Accepted: 19 August 2020 # The Author(s) 2020

Abstract Introduction and hypothesis Patient-reported outcome measures are fundamental tools when assessing effectiveness of treatments. The challenge lies in the interpretation: which magnitude of change in score is meaningful for the patients? The minimal important difference (MID) is defined as the smallest difference in score that patients perceive as important. The Patient Acceptable Symptom State (PASS) represents the value of score beyond which patients consider themselves well. We aimed to determine the MID and PASS for Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Organ Prolapse Distress Inventory6 (POPDI-6) in pelvic organ prolapse (POP) surgery. Methods We used data from 2704 POP surgeries from a prospective, population-based cohort. MID was determined with three anchor-based and one distribution-based method. PASS was defined using two different methods. Medians of the estimates were identified. Results The MID estimates with (1) mean change, (2) receiver-operating characteristic (ROC) curve, (3) 75th percentile, and (4) distribution-based method varied between 22.9–25.0 (median 24.2) points for PFDI-20 and 9.0–12.5 (median 11.3) for POPDI-6. The PASS cutoffs with (1) 75th percentile and (2) ROC curve method varied between 57.7–62.5 (median 60.0) for PFDI-20 and 16.7–17.7 (median 17.2) for POPDI-6. Conclusion A mean difference of 24 points in the PFDI-20 or 11 points in the POPDI-6 can be used as a clinically relevant difference between groups. Postoperative scores ≤ 60 for PFDI-20 and ≤ 17 for POPDI-6 signify acceptable symptom state. Keywords Minimal important difference . Patient-acceptable symptom state . Pelvic Floor Distress Inventory-20 . Pelvic Organ Prolapse Distress Inventory-6 . Pelvic organ prolapse surgery

Abbreviations PROM Patient-reported outcome measure MID Minimal important difference PASS Patient-acceptable symptom state PFDI-20 Pelvic Floor Distress Inventory-20 POP Pelvic organ prolapse

POPDI-6 ROC SD SEM SDC ICC

Pelvic Organ Prolapse Distress Inventory-6 Receiver-operating characteristics Standard deviation Standard error of measurement Smallest detectable change Intraclass correlation coefficient

Presentations Abstract accepted for oral presentation at the 45th Annual Meeting of International Urogynecology Association, Hague, The Netherlands, August 29–September 4, 2020 * Päivi K. Karjalainen [email protected]

4

Central Finland Hospital District, Jyväskylä, Finland

5

Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland

1

Department of Obstetrics and Gynecology, Central Finland Central Hospital, Keskussairaalantie 19, 40620 Jyväskylä, Finland

6

Department of Obstetrics and Gynecology, Tampere University Ho