Original Research
Gynecology
Responsiveness and minimally important difference of SF-6D and EQ-5D utility scores for the treatment of pelvic organ prolapse

Presented in part at PFD Week 2017, Providence, RI, Oct. 3, 2017.
https://doi.org/10.1016/j.ajog.2018.11.1094Get rights and content

Background

Utility preference scores are standardized, generic, health-related quality of life (HRQOL) measures that quantify disease severity and burden and summarize morbidity on a scale from 0 (death) to 1 (optimal health). Utility scores are widely used to measure HRQOL and in cost-effectiveness research.

Objective

To determine the responsiveness, validity properties, and minimal important difference (MID) of utility scores, as measured by the Short Form 6D (SF-6D) and EuroQol (EQ-5D), in women undergoing surgery for pelvic organ prolapse (POP).

Materials and Methods

This study combined data from 4 large, U.S., multicenter surgical trials enrolling 1321 women with pelvic organ prolapse. We collected condition-specific quality of life data using the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). A subset of women completed the SF6D; women in 2 trials also completed the EQ5D. Mean utility scores were compared from baseline to 12 months after surgery. Responsiveness was assessed using effect size (ES) and standardized response mean (SRM). Validity properties were assessed by (1) comparing changes in utility scores at 12 months between surgical successes and failures as defined in each study, and (2) correlating changes in utility scores with changes in the PFDI and PFIQ. MID was estimated using both anchor-based (SF-36 general health global rating scale “somewhat better” vs “no change”) and distribution-based methods.

Results

The mean SF-6D score improved 0.050, from 0.705 ± 0.126 at baseline to 0.761 ± 0.131 at 12 months (P < .01). The mean EQ-5D score improved 0.060, from 0.810 ± 0.15 at baseline to 0.868 ± 0.15 at 12 months (P < .01). The ES (0.13–0.61) and SRM (0.13–0.57) were in the small-to-moderate range, demonstrating the responsiveness of the SF-6D and EQ-5D similar to other conditions. SF-6D and EQ-5D scores improved more for prolapse reconstructive surgical successes than for failures. The SF-6D and EQ-5D scores correlated with each other (r = 0.41; n = 645) and with condition-specific instruments. Correlations with the PFDI and PFIQ and their prolapse subscales were in the low to moderate range (r = 0.09–0.38), similar to other studies. Using the anchor-based method, the MID was 0.026 for SF-6D and 0.025 for EQ-5D, within the range of MIDs reported in other populations and for other conditions. These findings were supported by distribution-based estimates.

Conclusion

The SF-6D and EQ-5D have good validity properties and are responsive, preference-based, utility and general HRQOL measures for women undergoing surgical treatment for prolapse. The MIDs for SF-6D and EQ-5D are similar and within the range found for other medical conditions.

Section snippets

Study design and participants

This study is a retrospective analysis that combined data from 4 large, U.S., multicenter POP surgical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)−sponsored Pelvic Floor Disorders Network (PFDN). The 4 trials were Outcomes following vaginal prolapse repair and mid urethral sling (OPUS),8 Operations and pelvic muscle training in the management of apical support loss (OPTIMAL),9 Colpopexy and Urinary Reduction Effort (CARE),10

Results

The methods and results of OPUS, OPTIMAL, CARE, and COLPO have been previously published.8, 9, 10, 11 These 4 studies enrolled a total of 1314 women (Table 1). The SF-6D was included in all 4 studies; the EQ-5D was included in CARE and COLPO. Women who had utility data at 12 months for the SF-6D (n = 1100) and EQ-5D (n = 715) were included in the current analysis. We included 410 of 466 women (88%) from OPUS, 309 of 374 (83%) from OPTIMAL, 284 of 322 (88%) from CARE and 118 of 152 (78%) from

Comment

This study shows that the SF-6D and EQ-5D have good validity properties and are responsive instruments for measuring the effect of reconstructive surgical treatment for POP. We observed moderate correlations of the SF-6D and EQ-5D scores with each other and condition-specific measures of POP symptoms and QOL, the PFDI and PFIQ, similar to other studies, demonstrating concurrent validity.7 For women undergoing reconstructive pelvic surgery for POP, scores for both instruments improved at 12

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    M.D.B reports Royalties from Elsevier, UpToDate; H.E.R. reports the following: Pelvalon, Consultant and grant support, Renovia, Consultant; Royalties from UptoDate; Travel funds IUGA; and Travel funds, ICS; NICHD, NIA, PCORI. A.G. reports Ninomed stock ownership. J.P.S. reports research support from Site PI for Myrbetriq trial supported by Astellas. R.G.R is DSMB chair for the TRANSFORM trial sponsored by American Medical Systems, and reports Stipend and travel from ABOG and IUGA and Royalties from Uptodate. The other authors report no conflict of interest.

    Financial support for this project was provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health (5U24HD069031-07).

    Cite this article as: Harvie HS, Honeycutt AA, Neuwahl SJ, et al. Responsiveness and minimally important difference of SF-6D and EQ-5D utility scores for the treatment of pelvic organ prolapse. Am J Obstet Gynecol 2019;220:265.e1-11.

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