- Email: [email protected]
Patient satisfaction and disease specific quality of life after uterine artery embolization
American Journal of Obstetrics and Gynecology (2004) 190, 1697e706
www.elsevier.com/locate/ajog
Patient satisfaction and disease specific quality of life after uterine artery embolization Wendy J. Smith, MD, MPH,a Elizabeth Upton, MS,b Elizabeth J. Shuster, MS,c Arnold J. Klein, MD,d Martin L. Schwartz, MD, PhDa Departments of Obstetrics and Gynecology,a and Radiology,d Northwest Permanente PC, Portland, Ore; Pacific University, School of Physician Assistants,b Forest Grove, Ore; Center for Health Research, Kaiser Permanente,c Portland, Ore
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– KEY WORDS Uterine artery embolization Fibroids Quality of life Satisfaction
Objectives: This study was undertaken to evaluate changes in fibroid specific symptom severity and health-related quality of life (HRQOL) after uterine artery embolization (UAE) and to consider the impact of these changes on satisfaction with the procedure. Study design: A validated, fibroid specific, symptom, and HRQOL questionnaire was mailed to 80 women who had undergone UAE from 1998 through 2002. Pre- and postprocedure symptom severity and HRQOL scores were obtained. The primary outcome measure was change in fibroid symptoms and HRQOL after UAE. Secondary outcomes included objective measures of patient satisfaction, and the decrease in uterine volume after UAE. Results: Questionnaires were completed by 64 women (80.0%) at a mean of 32.1 months from UAE (range: 57.5-6 months). After UAE, mean uterine volume decreased by 26.3% (95% CI 19.6-33.0), and 17 of 79 women (21.5%) underwent an additional procedure after a mean of 18.6 months. Symptom severity scores decreased by a mean of 35.2% (95% CI 29.3-41.1) and HRQOL scores increased by a mean of 35.7% (95% CI 28.9-42.4). Satisfaction with UAE was correlated with the change in symptom severity and HRQL scores (P ! .0001 and P = .0004, respectively) and the decrease in uterine volume after UAE (P = .0196). Conclusion: Women who undergo UAE have a significant decrease in symptom severity and increase in HRQOL, associated with high levels of satisfaction with the procedure, even when subsequent therapies are pursued. Ó 2004 Elsevier Inc. All rights reserved.
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Uterine fibroids affect between 20% and 50% of adult women, and fibroid-related symptoms, including
Presented at the Seventieth Annual Meeting of the Pacific Coast Obstetrical and Gynecological Society, September 16-21, 2003, Anchorage, Alaska. Reprints are not available from the authors. 0002-9378/$ - see front matter Ó 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.ajog.2004.02.043
bleeding, pain, pressure, and urinary symptoms result in an estimated 2 to 4 million person-days per year lost.1 Roughly, 200,000 to 400,000 surgical procedures are performed each year in the United States for symptomatic fibroids and an additional 3 to 7 million person-days are lost after surgery.1 Uterine artery embolization (UAE) is an alternative to hysterectomy, myomectomy, myolysis, and hormonal therapy for the treatment of
1698 symptomatic uterine fibroids. The potential advantages of UAE include a decreased cost and more rapid recovery compared with conventional therapies.2,3 In the assessment of disease severity, management, and therapeutic outcomes, clinicians tend to rely on objective clinical measures, such as hemoglobin levels and clinical or radiological change in uterine size.4 Women who are deciding their own plan of care for symptomatic fibroids may dispute the relevance of these measures.5 The major objective of any therapy for nonmalignant disease is to improve the patient’s health-related quality of life (HRQOL) by alleviating the symptoms associated with that condition.6 Studies evaluating the HRQOL both before hysterectomy and within the postoperative period indicate a negative impact on the health/functioning dimension of a woman’s quality of life, relative to asymptomatic controls.7 However, HRQOL assessments at 6 months and 1 year after hysterectomy are similar to controls.6 Thus, a HRQOL assessment is a useful tool to evaluate therapeutic outcomes in the treatment of nonmalignant disease. Studies evaluating outcomes and effectiveness of uterine artery embolization have used inconsistent and variable outcome criteria making direct comparisons between studies difficult.8 Most reports measure the success of UAE by the incidence of short-term complications, length of hospital stay, radiologic changes in uterine and/or fibroid volume, changes in symptomatology, and a review of subjective comments after the procedure.8-16 Only 1 study has evaluated changes in HRQOL measures in women who underwent UAE with the use of a validated health status questionnaire17; a second study used a nonvalidated, numerical rating scale to assess the impact of fibroid symptoms on women’s lives before and after UAE.18,19 In both studies a significant improvement in mean scores was noted after UAE, but with 6 months or less follow-up. To date, only 2 studies have reported on any UAE outcomes greater than 24 months after the procedure.10,20 In 1999, an expert panel convened and developed recommendations for UAE reporting standards and the direction of future research.1,21 As a result the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire, a validated, fibroid specific, symptom and HRQOL instrument, was developed.22 The UFS-QOL offers a reliable and reproducible measure of patientreported disease impact and outcome assessment after uterus-sparing therapies for fibroids. To date, there have been no published reports that used the UFS-QOL in this manner. The purpose of this study was to evaluate changes in fibroid-specific and HRQOL associated with UAE by using the UFS-QOL, and to consider the impact of specific factors, including the changes in symptom severity, HRQOL, and uterine size after UAE on patient satisfaction measures.
Smith et al
Material and methods Participants A total of 81 women underwent 82 UAE procedures at the Northwest Region of Kaiser Permanente between 1998 and 2002. All women who underwent embolization had symptomatic uterine fibroids encompassing menorrhagia, pain, pressure, or mass effects. Outcome data were obtained after a minimum of 6 months after UAE (range: 6.0-57.5 months). A full description of the UAE procedure and outcomes from the first 35 cases was previously published.14 Modifications in the procedure since the initial report include a change from the use of polyvinyl alcohol particles to tris-acryl gelatin microspheres (Embosphere, Biosphere Medical, Rockland, Mass) beginning with subject 54 in December 2000.
Assessments The Kaiser Permanente institutional review board approved the study. Surveys were mailed to 80 women (1 patient died of breast cancer approximately 2 years after the procedure). Postprocedural outcomes were available for all but 2 of the 81 patients who had undergone UAE either through survey contact or a computerized patient database; 1 patient had left the health plan immediately after her UAE procedure and could not be located, another left the plan 2 years after her procedure and thus, 1 year of follow-up is missing. The mailed survey consisted of the 37-question UFS-QOL (after obtaining permission for its use by the authors) modified to obtain fibroid specific symptom and HRQOL scores for each patient both before (by asking for a retrospective assessment) and after her UAE procedure, simultaneously. The self-administered questionnaire has 8 symptom and 29 HRQOL items; the HRQOL scale is comprised of 6 subscalesdconcern, activities, energy/mood, control, self-consciousness, and sexual function.22 Six additional questions (available on request) addressed issues of expectation for the procedure and satisfaction with the outcome. All response options were presented as 5level Likert scales. For the UFS-QOL, a score of 1 represented ‘‘none of the time’’ for the symptom frequency and HRQOL items, or ‘‘not at all’’ for the symptom severity items (in response to ‘‘how distressed were you...’’). For the satisfaction items, a score of 1 indicated dissatisfaction. Women who had had another procedure performed after UAE, including hysterectomy, myomectomy, or repeat embolization, were asked to respond to the post-UAE questions by recalling the 3 months before their subsequent procedure.
Statistics Demographic, baseline, and follow-up clinical data were summarized with the use of frequency, percentiles, and
1699
Smith et al means. Measurements of uterine size were based on ultrasound measurements before and at least 1 month after UAE. Uterine volumes were calculated by using the formula V = length ! depth ! width ! 0.5233 for an ellipsoid shape. The UFS-QOL scales and subscales were scored separately for each respondent before and after UAE as previously described.22 Two-tailed paired Student t tests were performed on all HRQOL and symptom severity scores to assess the change from baseline to time of survey completion, with P values of less than .05 considered statistically significant. A ‘‘global satisfaction score’’ was developed in a post hoc analysis by using the average scores from the 5 survey questions concerning patient satisfaction. These 5 variables were accurately summarized as a single variable as confirmed by the Cronbach coefficient alpha test. Pearson correlation coefficients were calculated to evaluate associations between each of the outcome measures, including percent change in uterine volume, HRQOL, and symptom severity scores, and satisfaction. All statistical analyses were completed with the use of the SAS system, version 8.2 for Windows (SAS, Cary NC).
Results Demographic and clinical outcome data A total of 79 UAE patients received questionnaires (1 was returned as undeliverable) and 64 women returned completed surveys (80.0%) between February and April 2003. The mean interval from procedure to survey completion was 32.1 G 13.5 months (range 6.0-57.5). The baseline patient demographic data is presented in Table I. Bilateral uterine artery embolization was accomplished in 91.4% (74/81) of cases; 1 patient who had a unilateral embolization procedure underwent a subsequent embolization of her contralateral artery because of persistent symptoms 9 months after the index procedure. There were no major complications; however, 11 women (13.6%) were hospitalized for the management of pain or low-grade fevers for a mean of 1.6 nights within 1 week of the UAE. There was a 26.3% reduction in mean uterine volume (678.4-504.2 cm3) after an average of 4.3 months after UAE. At a mean of 11.2 months from UAE, the mean uterine volume was 454.7 cm3, a 40.7% reduction from baseline. Of the 79 women for whom follow-up was available, 17 (21.5%) underwent a subsequent procedure for their symptomatic fibroids; 12 had hysterectomies, 4 had myomectomies, and 1 had a repeat UAE procedure. The mean time from UAE to subsequent treatment was 18.6 months (range 7.0-30.0). Women who had another procedure were significantly younger than those who did not, with a mean age of 42.5 years (95% CI 39.8-45.2) versus 46.6 years (95% CI 45.5-47.7). Their mean uter-
Table I
Baseline patient data (n = 81)
Category Demographics Mean age at UAE (y) Ethnicity (%) White Black Hispanic Asian Mean parity Mean BMI Normal weight (18.5-24.9) (%) Overweight (25.0-29.9) (%) Obese (R30.0) (%) Mean clinical uterine size (wks) Menopausal status (%) Premenopausal Postmenopausal Patient history (%) Presenting symptoms Menorrhagia Pain Pressure/mass symptoms Previous treatment Birth control pills or progestin Lupron Myomectomy Endometrial ablation Imaging data Mean uterine volume (cm3)
45.6 (32-56) 80.8 9.6 8.2 1.4 1 (0-7) 27.4 (20.4-47.0) 41.9 30.6 27.4 14.7 93.8 6.2
84.0 38.3 48.1 43.2 9.9 4.9 3.7 678.4 (97.8-2366.0)
Data in parentheses is the range. BMI, Body mass index.
ine volume before the UAE procedure was greater at 798.8 cm3 than women who did not undergo another procedure (648.8 cm3); however, this difference was not statistically significant (P = .3235). The initial mean uterine volume after UAE in women who had a subsequent procedure was 650.5 cm3, representing a 21.0% reduction from baseline. Women who did not undergo an additional procedure had a mean uterine volume of 457.3 cm3 after UAE, representing a 27.9% reduction from baseline. However, neither the follow-up mean uterine volume nor the percent reduction from baseline was statistically significant between the 2 groups of women (P = .2108 and P = .3951, respectively).
Mean scale and change scores Table II. contains data on both the mean scores and change scores of the symptom severity and quality of life scales from the baseline and post-UAE assessments. In all instances, mean symptom severity and HRQOL scores were improved at the follow-up assessment. All change scores from baseline to post-UAE reached statistical significance (P ! .0001). The concern subscale,
1700 Table II
Smith et al Quality of life scores
Scale
Baseline (n = 64) Mean G SD
Post-UAE (mean = 32.1 mos) Mean G SD
Change from baseline to Post-UAE Mean G SD
P value (Paired t test)
Symptom severity (range 0-100)*y Concern (range 0-100)zx Activities (range 0-100)zx Energy/mood (range 0-100)zx Control (range 0-100)zx Self-conscious (range 0-100)zx Sexual function (range 0-100)zx HRQL total (range 0-100)zx
61.61 38.83 44.81 48.90 48.75 47.14 48.17 44.92
26.42 82.27 84.71 79.85 82.27 73.31 78.28 80.58
35.19 e43.44 e39.89 e30.96 e33.51 e26.17 e30.11 e35.66
!.0001 !.0001 !.0001 !.0001 !.0001 !.0001 !.0001 !.0001
G G G G G G G G
20.95 30.31 29.48 31.68 31.10 31.57 32.87 25.24
G G G G G G G G
23.38 22.48 24.29 25.67 25.85 28.91 26.80 23.66
G G G G G G G G
23.58 31.48 30.46 29.66 30.52 29.24 33.15 27.10
* Higher score values indicate greater symptom severity or bother. y Positive change score represents improved functioning. z Higher score values indicate better HRQOL. x Negative change score represents improved functioning.
which focuses on concern regarding soiling garments, the inconvenience of carrying sanitary protection, and anxiety about the unpredictable onset of menses had both the lowest mean baseline score (indicating worse symptom-related quality of life) and the greatest change from baseline to post-UAE score. Women who had another treatment for their fibroids after UAE were found to have significantly different results in all scores when compared with women who did not undergo a second procedure. The mean change from baseline to post-UAE symptom severity in women who did not have another therapy was 40.4 (95% CI 34.146.8), whereas that in women having another treatment was 16.5 (95% CI 5.8-27.2) (P = .0004). The mean change for total HRQL score for the former group was e41.6 (95% CI e48.6 to e34.6) and for the latter group was e14.5 (95% CI e29.2-0.2; P = .0020) indicating a less improved HRQOL after UAE in the group of women who eventually had another procedure.
Correlations Table III lists the Pearson correlation coefficients for several primary and secondary outcome measures. The change in symptom severity score from baseline to post-UAE was significantly associated with the change in total HRQL score from these assessment points (P % .0001). Neither the change in symptom severity score nor the change in HRQL score was associated with the percentage of change (decrease) in uterine volume from pre-UAE to initial post-UAE measurement (P = .1617 and P = .2101, respectively. The global satisfaction score after UAE was significantly associated with the percent change in uterine volume (P = .0196) and the change in symptom severity and total HRQL scores (P % .0001 and P = .0004, respectively). However, satisfaction was not associated with the time since UAE was performed (P = .4569) or with baseline, preprocedure symptom severity (P = .3395) or HRQL (P = .9366) scores.
Expectation and satisfaction scores Patient expectation for and satisfaction with their UAE procedure is displayed in the Figure. More than 60% of respondents were very certain that UAE would improve their fibroid-related symptoms. All the respondents would recommend UAE to a friend with the same problems. In addition, 80% would probably or definitely choose UAE again for symptom treatment and only 1.6% would definitely not choose the procedure again. The mean value of the ‘‘global satisfaction score’’ was 3.975 on a 5-level Likert scale. Women who had another treatment for their fibroids after UAE were found to have a significantly lower global satisfaction score (mean 3.2; 95% CI 2.7-3.7) when compared with women who did not undergo a second procedure (mean 4.2; 95% CI 3.9-4.4; P = .002).
Comment The optimal treatment for benign uterine conditions, such as leiomyomata, is uncertain and may vary from woman to woman. Although fibroids are usually not life threatening, related symptoms, including bleeding, mass effects, and pain have a negative impact on a woman’s HRQOL, relative to women without the condition.22 Surgical treatments, including hysterectomy and myomectomy, are effective in some women; however, many women desire nonsurgical options that reduce symptoms and improve quality of life.4-7,20,23 Our study, and others, indicates that UAE is such an option.18,19 The clinical outcomes of our subjects after UAE were similar to that of other published reports.9,10,12,13,19
1701
Smith et al
Figure
Table III
Expectation for and satisfaction with UAE.
Pearson correlation coefficients Time since UAE procedure
Time since UAE procedure Percent change uterine volume* Change in total HRQL score Change in symptom severity score Global satisfaction score
1.00000 0.05948 0.6273 0.08826 0.4880 0.13476 0.2884 0.09465 0.4569
Percent change uterine volume 0.05948 0.6273 1.00000 0.17167 0.2101 0.19134 0.1617 0.31390 0.0196
Change in total HRQL score 0.08826 0.4880 0.17167 0.2101 1.00000 0.75000 !0.0001 0.43137 0.0004
Change in symptom severity score
Global satisfaction score
0.13476 0.2884 0.19134 0.1617 0.75000 !.0001 1.00000
0.09465 0.4569 0.31390 0.0196 0.43137 0.0004 0.60113 !.0001 1 .00000
0.60113 0.0001
Shaded values indicate statistical significance (P value ! .05). * Percent change in uterine volume measured from pre-UAE volume to first post-UAE volume (mean decrease in volume = 26.3%).
Because few prior studies contain follow-up data beyond 6 months to 2 years from UAE, it is difficult to compare our incidence of additional therapy for persistent or recurrent fibroid symptoms pursued after the index procedure with that of others. However, Broder et al20 describes 51 women who had undergone UAE an average of 46 months previously. Twenty-nine percent of this group had further invasive therapy after UAE, including 6 hysterectomies, 8 myomectomies, and 1 re-
peat embolization. The average time from UAE to subsequent procedure was not reported. Our incidence rate of 21.5% over a mean of 32.1 months with an average time to subsequent procedure of 18.6 months compares with their result. The primary goals of our study were to determine whether UAE could measurably reduce fibroid specific symptom severity and whether symptom changes occurring after UAE could significantly have an impact on
1702 HRQOL. We found that women who underwent UAE had significantly decreased fibroid-specific symptom severity and improved HRQOL, relative to their baseline measures. Even women who eventually had another therapy for their fibroid symptoms showed a statistically significant decrease in symptom severity and improvement in HRQOL. It is difficult to compare our subjects’ symptom severity and total HRQL scores before and after UAE with those of the only other currently published HRQOL study evaluating UAE using a standardized HRQOL instrument because the instruments used were different.17 Although the UFS-QOL was developed from this original questionnaire, only low-to-moderate correlations between the UFS-QOL and SF-36 (used in the previously published study) were found.22 Nonetheless, Spies et al17 did discover significantly improved functioning in almost every HRQOL and fibroid-specific symptom subscale at 3 and 6 months after UAE. In developing the UFS-QOL, the authors evaluated the discriminant validity of the questionnaire by comparing the results between women with symptomatic fibroids and normal women; the former were found to have a significantly higher symptom severity score and lower HRQL scores, indicating lower functioning, than controls.22 We found that the women who underwent UAE had even higher symptom severity scores and lower HRQL scores at baseline (before UAE) than the study sample of Spies et al.17 After UAE, all our subjects’ scores indicated improved functioning and were closer to those of the normal controls than the women with fibroids in the study or Spies et al. Spies et al determined that the concern and control subscales of the UFS-QOL were the most affected by fibroid-specific symptoms. Our study confirmed that the mean baseline value of the concern subscale demonstrated the lowest HRQOL score in our pre-UAE patients and that UAE resulted in the greatest improvement in this subscale. Patient satisfaction with UAE has been assessed by many studies evaluating patient outcomes after the procedure, but it has rarely been measured in a fashion that is reproducible or that allows for comparison with other studies.8-17,19 Our global satisfaction score consisting of 5 easily standardized questions could be adopted to assess satisfaction for any therapeutic option for a specific condition and thus allow for direct comparisons. In our study, the global satisfaction score was highly correlated with the change in total HRQL score and the change in symptom severity score, as well as the percent change in uterine volume after UAE. In contrast, the percent change in uterine volume after UAE was not directly related to either the change in symptom severity or total HRQL score. Thus, the global satisfaction score reflected the primary outcomes of interest after UAE, both clinical and patient-based, better than any of the other measures.
Smith et al There are several important limitations of this retrospective study. First, the baseline UFS-QOL was administered after the UAE procedure, and thus the data are subject to a potential recall bias. However, if recall bias were impacting the baseline data, we might expect to see a direct relationship between the global satisfaction score with the pre-UAE symptom severity and total HRQL scores. Although the global satisfaction score is associated with both the post-UAE symptom severity and total HRQL scores (P ! .0001 for both), it was not related to the pre-UAE scores (P = .3395 and P = .9366) suggesting a limited effect of recall bias. In the future, we plan to complete a prospective analysis. Secondly, the UFS-QOL was administered over varying times from the UAE procedure. Although the time interval between UAE and survey completion was not associated with changes in symptom severity, total HRQL, or the global satisfaction scores, administering the instrument at standardized times would allow for more uniform measures and avoid this potential bias. In addition, uncollected data from the surveys of nonrespondents may represent another source of bias. Available clinical outcomes from the majority of nonrespondents indicate that the mean percent decrease in uterine volume was smaller than that of respondents (5.5% vs 30.3%). Thus, we may anticipate that nonrespondents would have a lower global satisfaction score than respondents. Interestingly, nonrespondents were no more likely to have undergone a subsequent therapy for their fibroids than respondents. Further, women who elect to undergo UAE may not represent all women who have symptomatic fibroids. Thus, our results may not be generalizable to all women who have from this condition. Finally, the lack of significant associations between many of the outcome variables may be secondary to our small sample size and the possibility of type 2 error. This study provides additional data on the longterm outcomes of uterine artery embolization and demonstrates the first application of a newly developed HRQOL instrument specific to women with fibroids to evaluate the effectiveness of a therapy for this condition. Further, we developed a satisfaction score that is highly correlated with important outcomes and could serve as a tool to allow for comparisons of patient satisfaction across treatment options. Each woman must decide which, if any, treatment she will undergo for symptomatic fibroids. This decision may be based on a variety of factors and outcome measures, each of which carry its own unique weight for an individual woman. Although most outcome studies for UAE emphasize the percent change in uterine volume or short-term complication rates after the procedure, these outcomes may be of lesser value to patient decision making than the procedure’s ability to change her quality of life. Determining and creating more consistent measures of important patient outcomes for therapeutic alternatives for the
1703
Smith et al treatment of symptomatic fibroids should be our emphasis in the future.
References 1. Broder MS, Harris K, Morton SC, Sherbourne C, Brook RH. Uterine artery embolization: a systematic review of the literature and proposal for research. In: RAND report MR-1158. Santa Monica: RAND; 1999. 2. Al-Fozan H, Dufort J, Kaplow M, Valenti D, Tulandi T. Cost analysis of myomectomy, hysterectomy and uterine artery embolization. Am J Obstet Gynecol 2002;187:1401-4. 3. Baker CM, Winkel CA, Subramanian S, Spies JB. Estimated costs for uterine artery embolization and abdominal myomectomy for uterine leiomyomata: a comparative study at a single institution. J Vasc Interv Radiol 2002;13:1207-10. 4. Naughton MJ, Mcbee WL. Health-related quality of life after hysterectomy. Clin Obstet Gynecol 1997;40:947-57. 5. Nevadunsky NS, Bachmann GA, Nosher J, Yu T. Women’s decision-making determinants in choosing uterine artery embolization for symptomatic fibroids. J Reprod Med 2001;46:870-4. 6. Rock JA. Quality-of-life assessment in gynecologic surgery. J Reprod Med 2001;46:515-9. 7. Rannestad T, Eikeland O, Helland H, Qvarnstrom U. The quality of life in women suffering from gynecological disorders is improved by means of hysterectomy: absolute and relative differences between pre- and postoperative measures. Acta Obstet Gynecol Scand 2001;80:46-51. 8. Pinto I, Chimeno P, Romo A, Pau´l L, Haya J, de la Cal MA, Bajo J. Uterine fibroids: Uterine artery embolization versus abdominal hysterectomy for treatment: a prospective, randomized, and controlled clinical trial. Radiology 2003;226:425-31. 9. Brunereau L, Herbreteau D, Gallas S, Cottier J, Lebrun J, Tranquart F, et al. Uterine artery embolization in the primary treatment of uterine leiomyomas: technical features and prospective follow-up with clinical and sonographic examinations in 58 patients. AJR Am J Roentgenol 2000;175:1267-72. 10. Spies JB, Ascher SA, Roth AR, Kim J, Levy EB, Gomez-Jorge J. Uterine artery embolization for leiomyomata. Obstet Gynecol 2001;98:29-34. 11. Pelage J, Le Dref O, Soyer P, Kardache M, Dahan H, Abitbol M, et al. Fibroid-related menorrhagia: treatment with superselective embolization of the uterine arteries and midterm follow-up. Radiology 2000;215:428-31. 12. Goodwin SC, McLucas B, Lee M, Chen G, Perrella R, Vedantham S, et al. Uterine artery embolization for the treatment of uterine leiomyomata: midterm results. J Vasc Interv Radiol 1999;10: 1159-65. 13. Spies JB, Roth AR, Jha RC, Gomez-Jorge J, Levy EB, Chang TC, et al. Leiomyomata treated with uterine artery embolization: factors associated with successful symptom and imaging outcome. Radiology 2002;222:45-52. 14. Klein A, Schwartz ML. Uterine artery embolization for the treatment of uterine fibroids: an outpatient procedure. Am J Obstet Gynecol 2001;184:1556-63. 15. Hutchins FL, Worthington-Kirsch R, Berkowitz RP. Selective uterine artery embolization as primary treatment for symptomatic leiomyomata uteri. J Am Assoc Gynecol Laparosc 1999;6:279-84. 16. Watson GMT, Watson WJ. Uterine artery embolisation for the treatment of symptomatic fibroids in 114 women: reduction in size of the fibroids and women’s views of the success of the treatment. BJOG 2002;109:129-35. 17. Spies JB, Warren EH, Mathias SD, Walsh SM, Roth AR, Pentecost MJ. Uterine fibroid embolization: measurement of
18.
19.
20.
21.
22.
23.
health-related quality of life before and after therapy. J Vasc Interv Radiol 1999;10:1293-303. Pron G, Cohen M, Soucie J, Garvin G, Vanderburgh L, Bell S. The Ontario uterine fibroid embolization trial: part 1, baseline patient characteristics, fibroid burden, and impact on life. Fertil Steril 2003;79:112-9. Pron G, Bennett J, Common A, Wall J, Asch M, Sniderman K. The Ontario uterine fibroid embolization trial: part 2, uterine fibroid reduction and symptom relief after uterine artery embolization for fibroids. Fertil Steril 2003;79:120-7. Broder MS, Goodwin S, Chen G, Tang LJ, Costantino MM, Nguyen MH, et al. Comparison of long-term outcomes of myomectomy and uterine artery embolization. Obstet Gynecol 2002;100:864-8. Broder MS, Landow WJ, Goodwin SC, Brook RH, Sherbourne CD, Harris K. An agenda for research into uterine artery embolization:results of an expert panel conference. J Vasc Interv Radiol 2000;11:509-15. Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol 2002;99:290-300. Kjerulff KH, Rhodes JC, Lagenberg PW, Harvey LA. Patient satisfaction with results of hysterectomy. Am J Obstet Gynecol 2000;183:1440-7.
Editor’s note: This manuscript was revised after these discussions were presented.
Discussion DR MARTHA GOETSCH, Portland, Ore. This study examined patient satisfaction after UAE and succeeded in gathering data on a large group at a later point after embolization than other studies to date. It did not collect comparisons before and after embolization for each patient, as it was based on recollected preprocedure information, but the findings showed the usefulness of their questionnaire that is a validated tool to assess quality of life in women with fibroids. It showed clear differences in symptoms and quality of life in those who though the procedure succeeded compared with the group that had such continued problems that they underwent major surgery or repeat embolization within 2.5 years. What was the motivation for those choosing embolization? The overriding wishes described by this cohort were to avoid surgery and have a short recovery. The majority also wished to keep their uterus, but this was the third reason in order of priority. The study highlights interesting value judgments. Naturally, it is the patient who should judge her quality of life. Fibroids did not need to become small for women to believe that their result was worthwhile. Indeed, the average reduction in size was 40%, leaving many women with sizable masses but high satisfaction scores. This challenges the notion that we surgeons may hold that definitive and permanent cure is worth a lot, namely, invasive surgery and weeks of recovery.
www.elsevier.com/locate/ajog
Patient satisfaction and disease specific quality of life after uterine artery embolization Wendy J. Smith, MD, MPH,a Elizabeth Upton, MS,b Elizabeth J. Shuster, MS,c Arnold J. Klein, MD,d Martin L. Schwartz, MD, PhDa Departments of Obstetrics and Gynecology,a and Radiology,d Northwest Permanente PC, Portland, Ore; Pacific University, School of Physician Assistants,b Forest Grove, Ore; Center for Health Research, Kaiser Permanente,c Portland, Ore
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– KEY WORDS Uterine artery embolization Fibroids Quality of life Satisfaction
Objectives: This study was undertaken to evaluate changes in fibroid specific symptom severity and health-related quality of life (HRQOL) after uterine artery embolization (UAE) and to consider the impact of these changes on satisfaction with the procedure. Study design: A validated, fibroid specific, symptom, and HRQOL questionnaire was mailed to 80 women who had undergone UAE from 1998 through 2002. Pre- and postprocedure symptom severity and HRQOL scores were obtained. The primary outcome measure was change in fibroid symptoms and HRQOL after UAE. Secondary outcomes included objective measures of patient satisfaction, and the decrease in uterine volume after UAE. Results: Questionnaires were completed by 64 women (80.0%) at a mean of 32.1 months from UAE (range: 57.5-6 months). After UAE, mean uterine volume decreased by 26.3% (95% CI 19.6-33.0), and 17 of 79 women (21.5%) underwent an additional procedure after a mean of 18.6 months. Symptom severity scores decreased by a mean of 35.2% (95% CI 29.3-41.1) and HRQOL scores increased by a mean of 35.7% (95% CI 28.9-42.4). Satisfaction with UAE was correlated with the change in symptom severity and HRQL scores (P ! .0001 and P = .0004, respectively) and the decrease in uterine volume after UAE (P = .0196). Conclusion: Women who undergo UAE have a significant decrease in symptom severity and increase in HRQOL, associated with high levels of satisfaction with the procedure, even when subsequent therapies are pursued. Ó 2004 Elsevier Inc. All rights reserved.
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Uterine fibroids affect between 20% and 50% of adult women, and fibroid-related symptoms, including
Presented at the Seventieth Annual Meeting of the Pacific Coast Obstetrical and Gynecological Society, September 16-21, 2003, Anchorage, Alaska. Reprints are not available from the authors. 0002-9378/$ - see front matter Ó 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.ajog.2004.02.043
bleeding, pain, pressure, and urinary symptoms result in an estimated 2 to 4 million person-days per year lost.1 Roughly, 200,000 to 400,000 surgical procedures are performed each year in the United States for symptomatic fibroids and an additional 3 to 7 million person-days are lost after surgery.1 Uterine artery embolization (UAE) is an alternative to hysterectomy, myomectomy, myolysis, and hormonal therapy for the treatment of
1698 symptomatic uterine fibroids. The potential advantages of UAE include a decreased cost and more rapid recovery compared with conventional therapies.2,3 In the assessment of disease severity, management, and therapeutic outcomes, clinicians tend to rely on objective clinical measures, such as hemoglobin levels and clinical or radiological change in uterine size.4 Women who are deciding their own plan of care for symptomatic fibroids may dispute the relevance of these measures.5 The major objective of any therapy for nonmalignant disease is to improve the patient’s health-related quality of life (HRQOL) by alleviating the symptoms associated with that condition.6 Studies evaluating the HRQOL both before hysterectomy and within the postoperative period indicate a negative impact on the health/functioning dimension of a woman’s quality of life, relative to asymptomatic controls.7 However, HRQOL assessments at 6 months and 1 year after hysterectomy are similar to controls.6 Thus, a HRQOL assessment is a useful tool to evaluate therapeutic outcomes in the treatment of nonmalignant disease. Studies evaluating outcomes and effectiveness of uterine artery embolization have used inconsistent and variable outcome criteria making direct comparisons between studies difficult.8 Most reports measure the success of UAE by the incidence of short-term complications, length of hospital stay, radiologic changes in uterine and/or fibroid volume, changes in symptomatology, and a review of subjective comments after the procedure.8-16 Only 1 study has evaluated changes in HRQOL measures in women who underwent UAE with the use of a validated health status questionnaire17; a second study used a nonvalidated, numerical rating scale to assess the impact of fibroid symptoms on women’s lives before and after UAE.18,19 In both studies a significant improvement in mean scores was noted after UAE, but with 6 months or less follow-up. To date, only 2 studies have reported on any UAE outcomes greater than 24 months after the procedure.10,20 In 1999, an expert panel convened and developed recommendations for UAE reporting standards and the direction of future research.1,21 As a result the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire, a validated, fibroid specific, symptom and HRQOL instrument, was developed.22 The UFS-QOL offers a reliable and reproducible measure of patientreported disease impact and outcome assessment after uterus-sparing therapies for fibroids. To date, there have been no published reports that used the UFS-QOL in this manner. The purpose of this study was to evaluate changes in fibroid-specific and HRQOL associated with UAE by using the UFS-QOL, and to consider the impact of specific factors, including the changes in symptom severity, HRQOL, and uterine size after UAE on patient satisfaction measures.
Smith et al
Material and methods Participants A total of 81 women underwent 82 UAE procedures at the Northwest Region of Kaiser Permanente between 1998 and 2002. All women who underwent embolization had symptomatic uterine fibroids encompassing menorrhagia, pain, pressure, or mass effects. Outcome data were obtained after a minimum of 6 months after UAE (range: 6.0-57.5 months). A full description of the UAE procedure and outcomes from the first 35 cases was previously published.14 Modifications in the procedure since the initial report include a change from the use of polyvinyl alcohol particles to tris-acryl gelatin microspheres (Embosphere, Biosphere Medical, Rockland, Mass) beginning with subject 54 in December 2000.
Assessments The Kaiser Permanente institutional review board approved the study. Surveys were mailed to 80 women (1 patient died of breast cancer approximately 2 years after the procedure). Postprocedural outcomes were available for all but 2 of the 81 patients who had undergone UAE either through survey contact or a computerized patient database; 1 patient had left the health plan immediately after her UAE procedure and could not be located, another left the plan 2 years after her procedure and thus, 1 year of follow-up is missing. The mailed survey consisted of the 37-question UFS-QOL (after obtaining permission for its use by the authors) modified to obtain fibroid specific symptom and HRQOL scores for each patient both before (by asking for a retrospective assessment) and after her UAE procedure, simultaneously. The self-administered questionnaire has 8 symptom and 29 HRQOL items; the HRQOL scale is comprised of 6 subscalesdconcern, activities, energy/mood, control, self-consciousness, and sexual function.22 Six additional questions (available on request) addressed issues of expectation for the procedure and satisfaction with the outcome. All response options were presented as 5level Likert scales. For the UFS-QOL, a score of 1 represented ‘‘none of the time’’ for the symptom frequency and HRQOL items, or ‘‘not at all’’ for the symptom severity items (in response to ‘‘how distressed were you...’’). For the satisfaction items, a score of 1 indicated dissatisfaction. Women who had had another procedure performed after UAE, including hysterectomy, myomectomy, or repeat embolization, were asked to respond to the post-UAE questions by recalling the 3 months before their subsequent procedure.
Statistics Demographic, baseline, and follow-up clinical data were summarized with the use of frequency, percentiles, and
1699
Smith et al means. Measurements of uterine size were based on ultrasound measurements before and at least 1 month after UAE. Uterine volumes were calculated by using the formula V = length ! depth ! width ! 0.5233 for an ellipsoid shape. The UFS-QOL scales and subscales were scored separately for each respondent before and after UAE as previously described.22 Two-tailed paired Student t tests were performed on all HRQOL and symptom severity scores to assess the change from baseline to time of survey completion, with P values of less than .05 considered statistically significant. A ‘‘global satisfaction score’’ was developed in a post hoc analysis by using the average scores from the 5 survey questions concerning patient satisfaction. These 5 variables were accurately summarized as a single variable as confirmed by the Cronbach coefficient alpha test. Pearson correlation coefficients were calculated to evaluate associations between each of the outcome measures, including percent change in uterine volume, HRQOL, and symptom severity scores, and satisfaction. All statistical analyses were completed with the use of the SAS system, version 8.2 for Windows (SAS, Cary NC).
Results Demographic and clinical outcome data A total of 79 UAE patients received questionnaires (1 was returned as undeliverable) and 64 women returned completed surveys (80.0%) between February and April 2003. The mean interval from procedure to survey completion was 32.1 G 13.5 months (range 6.0-57.5). The baseline patient demographic data is presented in Table I. Bilateral uterine artery embolization was accomplished in 91.4% (74/81) of cases; 1 patient who had a unilateral embolization procedure underwent a subsequent embolization of her contralateral artery because of persistent symptoms 9 months after the index procedure. There were no major complications; however, 11 women (13.6%) were hospitalized for the management of pain or low-grade fevers for a mean of 1.6 nights within 1 week of the UAE. There was a 26.3% reduction in mean uterine volume (678.4-504.2 cm3) after an average of 4.3 months after UAE. At a mean of 11.2 months from UAE, the mean uterine volume was 454.7 cm3, a 40.7% reduction from baseline. Of the 79 women for whom follow-up was available, 17 (21.5%) underwent a subsequent procedure for their symptomatic fibroids; 12 had hysterectomies, 4 had myomectomies, and 1 had a repeat UAE procedure. The mean time from UAE to subsequent treatment was 18.6 months (range 7.0-30.0). Women who had another procedure were significantly younger than those who did not, with a mean age of 42.5 years (95% CI 39.8-45.2) versus 46.6 years (95% CI 45.5-47.7). Their mean uter-
Table I
Baseline patient data (n = 81)
Category Demographics Mean age at UAE (y) Ethnicity (%) White Black Hispanic Asian Mean parity Mean BMI Normal weight (18.5-24.9) (%) Overweight (25.0-29.9) (%) Obese (R30.0) (%) Mean clinical uterine size (wks) Menopausal status (%) Premenopausal Postmenopausal Patient history (%) Presenting symptoms Menorrhagia Pain Pressure/mass symptoms Previous treatment Birth control pills or progestin Lupron Myomectomy Endometrial ablation Imaging data Mean uterine volume (cm3)
45.6 (32-56) 80.8 9.6 8.2 1.4 1 (0-7) 27.4 (20.4-47.0) 41.9 30.6 27.4 14.7 93.8 6.2
84.0 38.3 48.1 43.2 9.9 4.9 3.7 678.4 (97.8-2366.0)
Data in parentheses is the range. BMI, Body mass index.
ine volume before the UAE procedure was greater at 798.8 cm3 than women who did not undergo another procedure (648.8 cm3); however, this difference was not statistically significant (P = .3235). The initial mean uterine volume after UAE in women who had a subsequent procedure was 650.5 cm3, representing a 21.0% reduction from baseline. Women who did not undergo an additional procedure had a mean uterine volume of 457.3 cm3 after UAE, representing a 27.9% reduction from baseline. However, neither the follow-up mean uterine volume nor the percent reduction from baseline was statistically significant between the 2 groups of women (P = .2108 and P = .3951, respectively).
Mean scale and change scores Table II. contains data on both the mean scores and change scores of the symptom severity and quality of life scales from the baseline and post-UAE assessments. In all instances, mean symptom severity and HRQOL scores were improved at the follow-up assessment. All change scores from baseline to post-UAE reached statistical significance (P ! .0001). The concern subscale,
1700 Table II
Smith et al Quality of life scores
Scale
Baseline (n = 64) Mean G SD
Post-UAE (mean = 32.1 mos) Mean G SD
Change from baseline to Post-UAE Mean G SD
P value (Paired t test)
Symptom severity (range 0-100)*y Concern (range 0-100)zx Activities (range 0-100)zx Energy/mood (range 0-100)zx Control (range 0-100)zx Self-conscious (range 0-100)zx Sexual function (range 0-100)zx HRQL total (range 0-100)zx
61.61 38.83 44.81 48.90 48.75 47.14 48.17 44.92
26.42 82.27 84.71 79.85 82.27 73.31 78.28 80.58
35.19 e43.44 e39.89 e30.96 e33.51 e26.17 e30.11 e35.66
!.0001 !.0001 !.0001 !.0001 !.0001 !.0001 !.0001 !.0001
G G G G G G G G
20.95 30.31 29.48 31.68 31.10 31.57 32.87 25.24
G G G G G G G G
23.38 22.48 24.29 25.67 25.85 28.91 26.80 23.66
G G G G G G G G
23.58 31.48 30.46 29.66 30.52 29.24 33.15 27.10
* Higher score values indicate greater symptom severity or bother. y Positive change score represents improved functioning. z Higher score values indicate better HRQOL. x Negative change score represents improved functioning.
which focuses on concern regarding soiling garments, the inconvenience of carrying sanitary protection, and anxiety about the unpredictable onset of menses had both the lowest mean baseline score (indicating worse symptom-related quality of life) and the greatest change from baseline to post-UAE score. Women who had another treatment for their fibroids after UAE were found to have significantly different results in all scores when compared with women who did not undergo a second procedure. The mean change from baseline to post-UAE symptom severity in women who did not have another therapy was 40.4 (95% CI 34.146.8), whereas that in women having another treatment was 16.5 (95% CI 5.8-27.2) (P = .0004). The mean change for total HRQL score for the former group was e41.6 (95% CI e48.6 to e34.6) and for the latter group was e14.5 (95% CI e29.2-0.2; P = .0020) indicating a less improved HRQOL after UAE in the group of women who eventually had another procedure.
Correlations Table III lists the Pearson correlation coefficients for several primary and secondary outcome measures. The change in symptom severity score from baseline to post-UAE was significantly associated with the change in total HRQL score from these assessment points (P % .0001). Neither the change in symptom severity score nor the change in HRQL score was associated with the percentage of change (decrease) in uterine volume from pre-UAE to initial post-UAE measurement (P = .1617 and P = .2101, respectively. The global satisfaction score after UAE was significantly associated with the percent change in uterine volume (P = .0196) and the change in symptom severity and total HRQL scores (P % .0001 and P = .0004, respectively). However, satisfaction was not associated with the time since UAE was performed (P = .4569) or with baseline, preprocedure symptom severity (P = .3395) or HRQL (P = .9366) scores.
Expectation and satisfaction scores Patient expectation for and satisfaction with their UAE procedure is displayed in the Figure. More than 60% of respondents were very certain that UAE would improve their fibroid-related symptoms. All the respondents would recommend UAE to a friend with the same problems. In addition, 80% would probably or definitely choose UAE again for symptom treatment and only 1.6% would definitely not choose the procedure again. The mean value of the ‘‘global satisfaction score’’ was 3.975 on a 5-level Likert scale. Women who had another treatment for their fibroids after UAE were found to have a significantly lower global satisfaction score (mean 3.2; 95% CI 2.7-3.7) when compared with women who did not undergo a second procedure (mean 4.2; 95% CI 3.9-4.4; P = .002).
Comment The optimal treatment for benign uterine conditions, such as leiomyomata, is uncertain and may vary from woman to woman. Although fibroids are usually not life threatening, related symptoms, including bleeding, mass effects, and pain have a negative impact on a woman’s HRQOL, relative to women without the condition.22 Surgical treatments, including hysterectomy and myomectomy, are effective in some women; however, many women desire nonsurgical options that reduce symptoms and improve quality of life.4-7,20,23 Our study, and others, indicates that UAE is such an option.18,19 The clinical outcomes of our subjects after UAE were similar to that of other published reports.9,10,12,13,19
1701
Smith et al
Figure
Table III
Expectation for and satisfaction with UAE.
Pearson correlation coefficients Time since UAE procedure
Time since UAE procedure Percent change uterine volume* Change in total HRQL score Change in symptom severity score Global satisfaction score
1.00000 0.05948 0.6273 0.08826 0.4880 0.13476 0.2884 0.09465 0.4569
Percent change uterine volume 0.05948 0.6273 1.00000 0.17167 0.2101 0.19134 0.1617 0.31390 0.0196
Change in total HRQL score 0.08826 0.4880 0.17167 0.2101 1.00000 0.75000 !0.0001 0.43137 0.0004
Change in symptom severity score
Global satisfaction score
0.13476 0.2884 0.19134 0.1617 0.75000 !.0001 1.00000
0.09465 0.4569 0.31390 0.0196 0.43137 0.0004 0.60113 !.0001 1 .00000
0.60113 0.0001
Shaded values indicate statistical significance (P value ! .05). * Percent change in uterine volume measured from pre-UAE volume to first post-UAE volume (mean decrease in volume = 26.3%).
Because few prior studies contain follow-up data beyond 6 months to 2 years from UAE, it is difficult to compare our incidence of additional therapy for persistent or recurrent fibroid symptoms pursued after the index procedure with that of others. However, Broder et al20 describes 51 women who had undergone UAE an average of 46 months previously. Twenty-nine percent of this group had further invasive therapy after UAE, including 6 hysterectomies, 8 myomectomies, and 1 re-
peat embolization. The average time from UAE to subsequent procedure was not reported. Our incidence rate of 21.5% over a mean of 32.1 months with an average time to subsequent procedure of 18.6 months compares with their result. The primary goals of our study were to determine whether UAE could measurably reduce fibroid specific symptom severity and whether symptom changes occurring after UAE could significantly have an impact on
1702 HRQOL. We found that women who underwent UAE had significantly decreased fibroid-specific symptom severity and improved HRQOL, relative to their baseline measures. Even women who eventually had another therapy for their fibroid symptoms showed a statistically significant decrease in symptom severity and improvement in HRQOL. It is difficult to compare our subjects’ symptom severity and total HRQL scores before and after UAE with those of the only other currently published HRQOL study evaluating UAE using a standardized HRQOL instrument because the instruments used were different.17 Although the UFS-QOL was developed from this original questionnaire, only low-to-moderate correlations between the UFS-QOL and SF-36 (used in the previously published study) were found.22 Nonetheless, Spies et al17 did discover significantly improved functioning in almost every HRQOL and fibroid-specific symptom subscale at 3 and 6 months after UAE. In developing the UFS-QOL, the authors evaluated the discriminant validity of the questionnaire by comparing the results between women with symptomatic fibroids and normal women; the former were found to have a significantly higher symptom severity score and lower HRQL scores, indicating lower functioning, than controls.22 We found that the women who underwent UAE had even higher symptom severity scores and lower HRQL scores at baseline (before UAE) than the study sample of Spies et al.17 After UAE, all our subjects’ scores indicated improved functioning and were closer to those of the normal controls than the women with fibroids in the study or Spies et al. Spies et al determined that the concern and control subscales of the UFS-QOL were the most affected by fibroid-specific symptoms. Our study confirmed that the mean baseline value of the concern subscale demonstrated the lowest HRQOL score in our pre-UAE patients and that UAE resulted in the greatest improvement in this subscale. Patient satisfaction with UAE has been assessed by many studies evaluating patient outcomes after the procedure, but it has rarely been measured in a fashion that is reproducible or that allows for comparison with other studies.8-17,19 Our global satisfaction score consisting of 5 easily standardized questions could be adopted to assess satisfaction for any therapeutic option for a specific condition and thus allow for direct comparisons. In our study, the global satisfaction score was highly correlated with the change in total HRQL score and the change in symptom severity score, as well as the percent change in uterine volume after UAE. In contrast, the percent change in uterine volume after UAE was not directly related to either the change in symptom severity or total HRQL score. Thus, the global satisfaction score reflected the primary outcomes of interest after UAE, both clinical and patient-based, better than any of the other measures.
Smith et al There are several important limitations of this retrospective study. First, the baseline UFS-QOL was administered after the UAE procedure, and thus the data are subject to a potential recall bias. However, if recall bias were impacting the baseline data, we might expect to see a direct relationship between the global satisfaction score with the pre-UAE symptom severity and total HRQL scores. Although the global satisfaction score is associated with both the post-UAE symptom severity and total HRQL scores (P ! .0001 for both), it was not related to the pre-UAE scores (P = .3395 and P = .9366) suggesting a limited effect of recall bias. In the future, we plan to complete a prospective analysis. Secondly, the UFS-QOL was administered over varying times from the UAE procedure. Although the time interval between UAE and survey completion was not associated with changes in symptom severity, total HRQL, or the global satisfaction scores, administering the instrument at standardized times would allow for more uniform measures and avoid this potential bias. In addition, uncollected data from the surveys of nonrespondents may represent another source of bias. Available clinical outcomes from the majority of nonrespondents indicate that the mean percent decrease in uterine volume was smaller than that of respondents (5.5% vs 30.3%). Thus, we may anticipate that nonrespondents would have a lower global satisfaction score than respondents. Interestingly, nonrespondents were no more likely to have undergone a subsequent therapy for their fibroids than respondents. Further, women who elect to undergo UAE may not represent all women who have symptomatic fibroids. Thus, our results may not be generalizable to all women who have from this condition. Finally, the lack of significant associations between many of the outcome variables may be secondary to our small sample size and the possibility of type 2 error. This study provides additional data on the longterm outcomes of uterine artery embolization and demonstrates the first application of a newly developed HRQOL instrument specific to women with fibroids to evaluate the effectiveness of a therapy for this condition. Further, we developed a satisfaction score that is highly correlated with important outcomes and could serve as a tool to allow for comparisons of patient satisfaction across treatment options. Each woman must decide which, if any, treatment she will undergo for symptomatic fibroids. This decision may be based on a variety of factors and outcome measures, each of which carry its own unique weight for an individual woman. Although most outcome studies for UAE emphasize the percent change in uterine volume or short-term complication rates after the procedure, these outcomes may be of lesser value to patient decision making than the procedure’s ability to change her quality of life. Determining and creating more consistent measures of important patient outcomes for therapeutic alternatives for the
1703
Smith et al treatment of symptomatic fibroids should be our emphasis in the future.
References 1. Broder MS, Harris K, Morton SC, Sherbourne C, Brook RH. Uterine artery embolization: a systematic review of the literature and proposal for research. In: RAND report MR-1158. Santa Monica: RAND; 1999. 2. Al-Fozan H, Dufort J, Kaplow M, Valenti D, Tulandi T. Cost analysis of myomectomy, hysterectomy and uterine artery embolization. Am J Obstet Gynecol 2002;187:1401-4. 3. Baker CM, Winkel CA, Subramanian S, Spies JB. Estimated costs for uterine artery embolization and abdominal myomectomy for uterine leiomyomata: a comparative study at a single institution. J Vasc Interv Radiol 2002;13:1207-10. 4. Naughton MJ, Mcbee WL. Health-related quality of life after hysterectomy. Clin Obstet Gynecol 1997;40:947-57. 5. Nevadunsky NS, Bachmann GA, Nosher J, Yu T. Women’s decision-making determinants in choosing uterine artery embolization for symptomatic fibroids. J Reprod Med 2001;46:870-4. 6. Rock JA. Quality-of-life assessment in gynecologic surgery. J Reprod Med 2001;46:515-9. 7. Rannestad T, Eikeland O, Helland H, Qvarnstrom U. The quality of life in women suffering from gynecological disorders is improved by means of hysterectomy: absolute and relative differences between pre- and postoperative measures. Acta Obstet Gynecol Scand 2001;80:46-51. 8. Pinto I, Chimeno P, Romo A, Pau´l L, Haya J, de la Cal MA, Bajo J. Uterine fibroids: Uterine artery embolization versus abdominal hysterectomy for treatment: a prospective, randomized, and controlled clinical trial. Radiology 2003;226:425-31. 9. Brunereau L, Herbreteau D, Gallas S, Cottier J, Lebrun J, Tranquart F, et al. Uterine artery embolization in the primary treatment of uterine leiomyomas: technical features and prospective follow-up with clinical and sonographic examinations in 58 patients. AJR Am J Roentgenol 2000;175:1267-72. 10. Spies JB, Ascher SA, Roth AR, Kim J, Levy EB, Gomez-Jorge J. Uterine artery embolization for leiomyomata. Obstet Gynecol 2001;98:29-34. 11. Pelage J, Le Dref O, Soyer P, Kardache M, Dahan H, Abitbol M, et al. Fibroid-related menorrhagia: treatment with superselective embolization of the uterine arteries and midterm follow-up. Radiology 2000;215:428-31. 12. Goodwin SC, McLucas B, Lee M, Chen G, Perrella R, Vedantham S, et al. Uterine artery embolization for the treatment of uterine leiomyomata: midterm results. J Vasc Interv Radiol 1999;10: 1159-65. 13. Spies JB, Roth AR, Jha RC, Gomez-Jorge J, Levy EB, Chang TC, et al. Leiomyomata treated with uterine artery embolization: factors associated with successful symptom and imaging outcome. Radiology 2002;222:45-52. 14. Klein A, Schwartz ML. Uterine artery embolization for the treatment of uterine fibroids: an outpatient procedure. Am J Obstet Gynecol 2001;184:1556-63. 15. Hutchins FL, Worthington-Kirsch R, Berkowitz RP. Selective uterine artery embolization as primary treatment for symptomatic leiomyomata uteri. J Am Assoc Gynecol Laparosc 1999;6:279-84. 16. Watson GMT, Watson WJ. Uterine artery embolisation for the treatment of symptomatic fibroids in 114 women: reduction in size of the fibroids and women’s views of the success of the treatment. BJOG 2002;109:129-35. 17. Spies JB, Warren EH, Mathias SD, Walsh SM, Roth AR, Pentecost MJ. Uterine fibroid embolization: measurement of
18.
19.
20.
21.
22.
23.
health-related quality of life before and after therapy. J Vasc Interv Radiol 1999;10:1293-303. Pron G, Cohen M, Soucie J, Garvin G, Vanderburgh L, Bell S. The Ontario uterine fibroid embolization trial: part 1, baseline patient characteristics, fibroid burden, and impact on life. Fertil Steril 2003;79:112-9. Pron G, Bennett J, Common A, Wall J, Asch M, Sniderman K. The Ontario uterine fibroid embolization trial: part 2, uterine fibroid reduction and symptom relief after uterine artery embolization for fibroids. Fertil Steril 2003;79:120-7. Broder MS, Goodwin S, Chen G, Tang LJ, Costantino MM, Nguyen MH, et al. Comparison of long-term outcomes of myomectomy and uterine artery embolization. Obstet Gynecol 2002;100:864-8. Broder MS, Landow WJ, Goodwin SC, Brook RH, Sherbourne CD, Harris K. An agenda for research into uterine artery embolization:results of an expert panel conference. J Vasc Interv Radiol 2000;11:509-15. Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol 2002;99:290-300. Kjerulff KH, Rhodes JC, Lagenberg PW, Harvey LA. Patient satisfaction with results of hysterectomy. Am J Obstet Gynecol 2000;183:1440-7.
Editor’s note: This manuscript was revised after these discussions were presented.
Discussion DR MARTHA GOETSCH, Portland, Ore. This study examined patient satisfaction after UAE and succeeded in gathering data on a large group at a later point after embolization than other studies to date. It did not collect comparisons before and after embolization for each patient, as it was based on recollected preprocedure information, but the findings showed the usefulness of their questionnaire that is a validated tool to assess quality of life in women with fibroids. It showed clear differences in symptoms and quality of life in those who though the procedure succeeded compared with the group that had such continued problems that they underwent major surgery or repeat embolization within 2.5 years. What was the motivation for those choosing embolization? The overriding wishes described by this cohort were to avoid surgery and have a short recovery. The majority also wished to keep their uterus, but this was the third reason in order of priority. The study highlights interesting value judgments. Naturally, it is the patient who should judge her quality of life. Fibroids did not need to become small for women to believe that their result was worthwhile. Indeed, the average reduction in size was 40%, leaving many women with sizable masses but high satisfaction scores. This challenges the notion that we surgeons may hold that definitive and permanent cure is worth a lot, namely, invasive surgery and weeks of recovery.