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Noncancerous pelvic conditions in premenopausal women are common and burdensome. Although a number of minimally invasive and nonsurgical treatment approaches have emerged,1–7 hysterectomy continues to be widely used to treat these problems. In 2004, 617,000 hysterectomies were performed,8 most commonly for noncancerous conditions, including leiomyomata (60%), pelvic relaxation (11%), pain (9%), and bleeding (8%).9
Although cohort studies and randomized trials have demonstrated the benefits of hysterectomy during the first 1–2 years after surgery,7,10–12 the long-term effect of this common procedure on patient satisfaction, overall health, and health-related quality of life is not well understood. Moreover, sociodemographic, attitudinal, and health-related quality-of-life predictors of future hysterectomy use among sociodemographically diverse women have not been extensively studied.
To better understand the effect of noncancerous pelvic problems on health-related quality of life and sexual functioning over time and identify predictors of use of and longer-term satisfaction with hysterectomy and alternative treatments, we are conducting a longitudinal study of women experiencing pelvic pain, abnormal uterine bleeding, and/or pelvic pressure. Women enrolled in the Study of Pelvic Problems, Hysterectomy, and Intervention Alternatives (SOPHIA) will be followed for up to 8 years. We previously reported on clinical predictors of hysterectomy use among the first half of the women who enrolled in SOPHIA.13 In this report, we present the sociodemographic, clinical, attitudinal, health-related quality-of-life and sexual functioning characteristics of the entire group of 1,493 SOPHIA participants according to their leading symptoms at the time of enrollment. We also describe the association between sociodemographic and clinical characteristics and prior use of and satisfaction with Western and complementary treatments.
MATERIALS AND METHODS
We recruited premenopausal women, aged 31–54 years, who had sought care in the previous year for pelvic pain, abnormal uterine bleeding (heavy, prolonged, or irregular), and/or symptomatic uterine leiomyomata (with abnormal bleeding or pressure) at clinics and practices affiliated with the University of California, San Francisco, San Francisco General Hospital, Kaiser Permanente Northern California, or one of several community hospitals in San Francisco. Patients joined the study at one of two time points: 1998/1999 (Cohort I) or 2003/2004 (Cohort II). Eligibility criteria included neither having previously undergone nor being scheduled to undergo hysterectomy and an ability to speak English, Spanish, or Chinese (Mandarin or Cantonese). Because of our focus on noncancerous conditions, women who had a history of cancer of the reproductive tract were excluded. The study was approved by the University of California Committee on Human Research and the Kaiser Permanente and San Francisco General Hospital Institutional Review Boards.
Potentially eligible participants were identified by searching clinic databases for women who had been seen for one of the conditions in the past 12 months. These women were sent letters describing the study and informing them that a research associate would be calling them unless they returned the enclosed preaddressed and stamped opt-out postcard. At the community practices, flyers with information and contact telephone numbers were posted and distributed. Potentially eligible and interested women were screened by telephone; informed consent was obtained at the beginning of each interview.
Each interview was conducted by a research associate speaking the participant's primary language, using interview materials that were forward- and back-translated into Spanish and Chinese by bilingual, bicultural translators and pretested on 35 women meeting study entry criteria. At the beginning of the interview, each participant was asked about her symptoms and then placed into one of five clinical groups based on the symptoms she was experiencing and diagnoses she had received: 1) pelvic pain only, 2) pelvic pain and abnormal uterine bleeding, with or without leiomyomata, 3) abnormal uterine bleeding without uterine leiomyomata, 4) abnormal uterine bleeding with leiomyomata, or 5) pelvic pressure with leiomyomata. She was then asked to complete an interviewer-administered questionnaire, which asked about sociodemographic, clinical, and attitudinal characteristics, prior treatments and treatment satisfaction, and health-related quality of life and sexual functioning, and a computerized preference-elicitation exercise.
Measures used in Cohort I were expanded upon in Cohort II to gain a deeper understanding of the effect of noncancerous pelvic problems on depression, urinary incontinence, and sexual functioning. To assess the presence of depression, we used the 9-item depression component of the Primary Care Evaluation of Mental Disorders (PRIME-MD) screening instrument,14 a validated diagnostic instrument that has been used to document the prevalence of mental disorders among gynecology patients.15 Urinary incontinence measures included an 9-item measure of urinary symptoms adapted from the Urinary Distress Inventory,16 and a 1-item yes/no global measure of urinary incontinence (“During the past 4 weeks, did you experience any urinary incontinence? By urinary incontinence, we mean involuntary loss of urine with coughing, sneezing, laughing, straining, or movement, or loss of urine before reaching the toilet.”).
Attitudes and beliefs about pelvic problems and their treatments were measured in Cohort I by using a series of statements addressing themes that emerged during focus group discussions. Participants were asked to indicate their level of agreement with these statements using 7-point response options (1=strongly disagree to 7=strongly agree). In Cohort II we expanded the attitude measures to include additional scales and individual items used in a separate cohort study to predict satisfaction with progestin treatment for abnormal uterine bleeding.17 Factor analysis18 of the attitude statements common to both cohorts yielded three interpretable factors: “Benefits of Not Having a Uterus,” consisting of three items (“menstruation is one of the downsides of being a woman,” “the uterus is useless to women who have completed childbearing,” “if I had a hysterectomy I would feel happy not to have to worry about birth control”); “Hysterectomy Concerns,” consisting of three statements about feeling older, violated, and sad about losing one's fertility if one had a hysterectomy, and “Value of Uterus,” which included two statements about the perceived importance of having a uterus for sexual enjoyment and its role in feeling complete as a woman. All three scales were scored as the unweighted average of the responses to the individual items.
We asked each participant about her current and prior use of treatments for her uterine condition, including hormones, analgesics, dilation and curettage, myomectomy, uterine artery embolization, endometrial ablation, acupuncture, and medicinal herbs. She then was asked to rate how satisfied she was with the Western and complementary alternative treatments she had tried.
Overall health-related quality-of-life in Cohort I was measured by using the Medical Outcomes Study (MOS)19 Short Form (SF)-12,20 three items adapted from the Maine10 and Maryland21 Women's Health Studies, and a Pelvic Problem Impact Questionnaire adapted from the Urinary Incontinence Impact Questionnaire.16 For Cohort II, we added the complete MOS SF-36 scale,22 and the 5-item version of the MOS health distress scale.23 All health-related qualify-of-life scales were transformed to 0-to-100 scales, with 100 denoting optimal functioning.
In Cohort I we assessed sexual functioning by asking participants questions about the importance of sex in their lives and the frequency of sexual desire and activity. Because of our interest in further understanding the effect of noncancerous pelvic problems on sexual functioning, in Cohort II we administered the MOS Sexual Problems Scale24 and four other validated scales measuring sexual desire, orgasm frequency and quality, satisfaction with sex, and body image.25,26 All sexual function scales were scored by taking the unweighted average of responses to the individual items and transforming them to a 0-to-100 scale. Higher scores denoted more optimal functioning (eg, fewer sex problems, more desire, greater orgasm frequency and quality, more satisfaction, and more positive body image). Psychometric properties of all scales are reported in the Appendix, available online at www.greenjournal.org/cgi/content/full/110/3/633/DC1.
We used the time tradeoff metric to measure preferences or utilities for current health.27 This metric quantifies preferences for experienced or hypothetical health outcomes by asking individuals how many years of their lives they would be willing to give up to live their remaining years without the symptoms or health condition being assessed. Values range from 0=dead to 1=ideal health in the absence of the condition or outcome being assessed. To assess their current health utility, each SOPHIA participant was asked to consider a choice between living her full remaining life with the symptoms she was experiencing and living a shorter life without those symptoms. The number of years she was willing to give up to achieve “ideal health” (no symptoms) was varied until she reached a point of indifference between the two choices. The time tradeoff utility for her current health was then calculated as the reduced life expectancy with no symptoms divided by her full life expectancy with symptoms at her indifference point.
We calculated means, standard deviations, and percentages for sociodemographic, clinical, and attitudinal characteristics for the entire group, and health-related quality of life and sexual functioning characteristics for the five clinical subgroups. We then fit multivariable logistic regression models of outcomes describing satisfaction with Western treatments and complementary or other treatments. Explanatory variables included sociodemographic, clinical, and other variables that we hypothesized were associated with these outcomes. A backward elimination procedure removed nonsignificant explanatory variables (P>.15) from multivariable models. Because the data contained missing values, we fit all models to 20 multiply imputed data sets created with SAS PROC MI (SAS 9.1, 2006; SAS Institute Inc, Cary, NC). The imputation model included all variables included in Tables 1 through 3 and was fit separately for each cohort. Imputed values for binary and categorical variables were rounded and truncated to the nearest category.28,29 Parameters and standard errors were estimated by combining results across the 20 imputed data sets, following Rubin's rules.30,31
To recruit participants for the SOPHIA study, we mailed letters to 7,770 women (4,349 in 1998/1999 and 3,421 in 2003/2004). Contact was established with 5,829 women, of whom 3,261 were found to be eligible and 1,493 enrolled. The most common reasons for declining participation were lack of time or interest. The SOPHIA enrollees constituted a sociodemographically diverse group of women receiving care at a wide range of practice types, including a closed-panel health maintenance organization (Kaiser Permanente Northern California, 41.7%), an academic institution (University of California, San Francisco, 29.4%), a county facility (San Francisco General Hospital, 21.2%), or one of a number of community practices (7.7%). The mean age at the time of enrollment was 42.5 years. About half (54.0%) of these women were married or living with a partner, and half (53.6%) had previously given birth. All four major racial or ethnic groups were well represented. One quarter (23.7%) of the participants were born outside of the United States, with 10.7% electing to be interviewed in Spanish or Chinese. Overall, half (51.3%) did not have college degrees, and all income and occupational prestige categories also were well represented.
More than two thirds of these women were experiencing heavy or frequent bleeding (71.0%) and/or pelvic pain (72.5%) at enrollment (Table 1).14,32 About a third (32.7%) had pelvic pressure. Many reported other bothersome symptoms, including dyspareunia (10.8%), menstrual cramps (27.8%), and lower back pain (38.1%). Most (82.7%) reported that their pelvic symptoms were only somewhat or not at all resolved. In addition, 40.2% reported experiencing urinary incontinence in the past 4 weeks, and 12.6% met Patient Health Questionnaire criteria for major depressive disorder.
The majority (58.2%) of SOPHIA enrollees indicated that they were willing to consider a hysterectomy. Many (30.8%) reported desiring a future pregnancy, including 24.4% of the women who were willing to consider hysterectomy. Although the mean scores on the attitude measures were all near 4, the neutral position on these 1-to-7 scales, there was substantial variation in these attitudes, and in each case the full range of response options were endorsed. The mean Benefits of Not Having a Uterus score was 3.8, for example, with 17.1% scoring in the 1-to-2 range, indicating a fair amount of disagreement with this construct, and 11.0% generating scores between 6 and 7, indicating strong endorsement. The Concerns About Hysterectomy Scale yielded a mean score of 4.0, with 23.3% endorsing having substantial concerns and 23.2% scoring between 1 and 2, indicating lack of concern. Finally, the mean score on the Value of Having a Uterus Scale was 4.5; and 36.3% endorsed this concept while 12.7% had scores in the 1-to-2 range.
Participants in SOPHIA were experiencing substantial effects of their condition on their health-related quality of life and sexual functioning (Table 2). Depending on their presenting symptoms, 60.3–76.7% reported feeling “mixed” or “somewhat” or “very dissatisfied” with their symptoms. Mean Pelvic Problem Impact Questionnaire scores ranged from 26 to 39, suggesting that symptoms were having a moderate amount of effect on activities, roles, and emotional states. Less than half (42.0%) of the women in the combined cohort reported that their overall health was excellent or very good, and only 17.0% were satisfied with their health. Mean SF-12 Mental Component Summary scores and Physical Component Summary scores ranged from 41 to 44 and 43 to 49, respectively, and mean current health utility scores ranged from 0.78 to 0.88.
A quarter (24.1%) of the SOPHIA participants reported that they had not had sexual activity with or without a partner in the 4 weeks before study enrollment. Lack of sexual activity among these women was attributed to pelvic problems (32.9%), to lack of a partner (28.8%), and to sex not being an important part of life (18.8%). A third (32.1%) of the SOPHIA participants reported that their ability to have and enjoy sex had worsened in the past 6 months, with 15.7% reporting substantial worsening. Moreover, 42.3% of the SOPHIA enrollees felt that their pelvic problems were interfering “quite a bit” or “a great deal” with sex. Mean scores on the sexual functioning and body image scales ranged from 48.1 to 75.5, indicating substantial impairment in these domains.
Not surprisingly, given their efficacy for pain and bleeding, nonsteroidal anti-inflammatory agents were used by most participants (77.0%, Table 3). Although dilation and curettage was the most common surgical treatment (17.1%), a similar number (17.9%) had tried acupuncture, and many more (36.3%) had tried herbs for their pelvic problem. Treatment satisfaction rates ranged from 20.0% for dilation and curettage to 58.2% for opiates, while the rate of bothersome adverse effects ranged from 2.5% for Kegel exercises to 79.4% for gonadotropin-releasing hormone agonists. The highest rates of substantial worsening in sexual functioning were reported by women who were using gonadotropin-releasing hormone agonists (50.0%) as well as those who were using progestin pills and implants (25.6%).
Results of our analyses of the association between SOPHIA participants' characteristics and their satisfaction with prior Western and other treatments are presented in Table 4.33 In univariable analyses, several clinical and health-related quality-of-life variables, along with education and site for care, were associated with treatment satisfaction. Multivariable analyses yielded significant independent associations of Western treatment satisfaction with lower educational attainment, greater symptom resolution, higher Physical Component Summary scores, and less symptom interference with sex. Independent associations of satisfaction with complementary and other treatments were found with lower income, less educational attainment, fewer Western medicines and more alternative treatments tried, greater symptom resolution, and higher Mental Component Summary scores. Race/ethnicity also was found to be a significant independent predictor of satisfaction with complementary and other treatments, with Asian and white women having lower odds of being satisfied than African-American women.
We have successfully recruited a diverse group of women seeking care for noncancerous pelvic problems in a number of different practice settings. The 1,493 women who enrolled in SOPHIA represent a broad spectrum of experience with symptoms and prior treatments and a wide range of attitudes toward the uterus and hysterectomy as a treatment for pelvic problems. Over time we hope to identify risk factors for poor outcomes of hysterectomy and alternatives, as well as to identify groups of women who are most likely to benefit from these interventions.
Results of this cross-sectional analysis demonstrate the profound effect that noncancerous pelvic problems have on health and well-being. The mean SF-12 Mental Component Summary (40.9 to 43.7) and Physical Component Summary (43.1 to 48.6) scores of the SOPHIA participants were substantially lower than population norms for noninstitutionalized women aged 40–49 years (49.7 and 49.54, respectively)34 and similar to those of women with chronic hepatitis C.35 Mean current health time tradeoff scores ranged from 0.78 (bleeding and pain) to 0.88 (leiomyomata with pressure) and were similar to the time tradeoff utilities that have been reported for primary care patients experiencing chronic medical conditions, including depression (0.86),36 untreated erosive esophagitis (0.87),37 and rheumatoid arthritis (0.78).38
Sexual functioning emerged as a particularly important domain in all symptom groups. Most participants agreed that sex was an important part of life, but many were dissatisfied with their sex lives, felt that their ability to have and enjoy sex had worsened in the past 6 months, and attributed this dissatisfaction to their pelvic problems. Mean scores on the Medical Outcomes Study Sexual Problems Scale and the other sexual functioning scales were somewhat better than baseline scores for women who participated in two previous studies of women with abnormal uterine bleeding (who were experiencing heavy abnormal uterine bleeding for an average of 11 days per month), but substantially worse than the scores those women reported 2 years postrandomization to hysterectomy or expanded medical treatment.11,26
We were able to identify some potentially important correlates of treatment satisfaction in our cohort, including several health-related quality-of-life variables that are independently associated with satisfaction with Western and complementary treatments used before study enrollment. These included better overall mental and physical health and less pelvic problem interference with sex, further underscoring the important role that health-related quality of life and sexual functioning plays in patients' experiences of successful compared with ineffective treatment.
Importantly, these initial findings are not sufficient to change clinical practice. Future SOPHIA study reports will explore the extent to which symptoms, health-related quality of life, and sexual functioning change over time and predict use of and satisfaction with hysterectomy and alternative treatments for noncancerous pelvic problems. Knowledge of the likely treatment outcomes will enable providers to counsel their patients toward more informed decisions regarding treatment.
Although investigators increasingly use health-related quality-of-life and sexual functioning outcomes as measures of the effectiveness of specific interventions for pelvic problems,11,26,39–42 little is known about the long-term effect of these conditions and their treatments. Understanding is also limited concerning the role that health-related quality of life and sexual functioning, as well as patient preferences and attitudes, might play in future treatment decisions and long-term treatment satisfaction. By grouping SOPHIA participants according to their diagnoses and symptoms at baseline, we have created subcohorts of women with pelvic pain, abnormal uterine bleeding, or pelvic pressure or a combination of these, including women with symptomatic leiomyomata, who will be followed for up to 8 years. The SOPHIA study will shed important new light on the natural history and the effectiveness of condition-specific treatments for these common symptoms and diagnoses.
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