Impact of uterine fibroid symptoms on health-related quality of life of US women: evidence from a cross-sectional survey.

BACKGROUND: Uterine fibroids (UF) are associated with significant health-related quality of life (HRQL) impact. This study examined the impact of UF symptoms on HRQL. METHODS: An online cross-sectional survey of 18 to 49 year old US women was conducted and collected demographics, UF prevalence, symptoms, and HRQL using the UFS-QOL. Descriptive statistics were used to examine the impact of symptom presence, severity, bothersomeness, and number of UF symptoms on HRQL. Analyses were weighted to match the US female population distribution. Multivariate regressions were performed with each subscale as a dependent variable to examine the impact of individual UF symptoms on HRQL. RESULTS: A total of 59,411 (15.5%) panel members completed the prevalence screener; 4848 met inclusion criteria; 955 had UF and no hysterectomy. Mean age was 40.3; 58% were white; 63% were married/civil union. Common UF symptoms were: lower back pain (65%), fatigue/weariness (63%), bloating (61%), pelvic pain/cramping during menses (63%), and heavy bleeding during menses (54%). Mean UFS-QoL subscale scores were significantly (p < .05) worse among women with a UF symptom versus women without the symptom. Women who rated their UF symptoms as severe had significantly (p < .001) worse UFS-QoL scores than women with mild or moderate symptoms. UFS-QoL subscale scores worsened as the number of symptoms increased. In the regressions, the presence of bleeding and non-bleeding symptoms were related to worse UFS-QoL subscale scores. CONCLUSION: HRQL among women with UF was significantly impacted by UF-related symptoms. Greater impact was observed as the number and severity of symptoms increased.

The burden of endometriosis symptoms on health-related quality of life in women in the United States: a cross-sectional study.

INTRODUCTION: To examine the symptomatic burden of endometriosis on health-related quality of life (HRQL) in women in the United States (US). METHODS: A cross sectional web-based survey study was conducted among women using survey panels. The survey included study-specific questions and standardized HRQL questionnaires. Participants reviewed a list of endometriosis symptoms and selected all symptoms they had ever or were currently experiencing. For current symptoms, participants rated the severity and bothersomeness of each symptom. Participants completed the endometriosis health profile (EHP-30) core questionnaire. Descriptive analyzes were performed and multivariate regressions were run with each EHP subscale as a dependent variable to examine the impact of symptoms while controlling for age and comorbid conditions. RESULTS: Mean age of the 1269 women was 34.3 ± 0.3; 78% were white. At least 75% reported having ever experienced: pelvic pain/cramping during their menstrual period, anxiety/stress, lower back pain or fatigue/weariness/anemia. EHP-30 scores ranged from 33.6 (95% CI: 31.4, 35.8) (social support) to 37.8 (95% CI: 35.5, 40.1) (control and powerlessness), indicating moderate HRQL impact. For all but one domain and one symptom, EHP-30 scores were significantly higher (worse) for women who had individual endometriosis-related symptoms than for those who did not. EHP-30 scores consistently deteriorated with each increase in the number of symptoms experienced and by increasing perceived disease severity. Pelvic pain/cramping during menstrual period, irregular periods and general abdominal pain were significantly associated with the EHP-30 domain scores in the regression models. CONCLUSION: Experiencing endometriosis symptoms is associated with lower HRQL. Importantly, as symptom severity and number of symptoms increase, HRQL further deteriorates.

Patient-reported prevalence and symptomatic burden of uterine fibroids among women in the United States: findings from a cross-sectional survey analysis.

PURPOSE: To estimate the prevalence of women diagnosed with uterine fibroids and the associated symptom burden in the US. PATIENTS AND METHODS: Responses of women aged 18-54 years, who completed an online survey, were analyzed. Data were weighted based on age, education, race, geographic region, income, and propensity score to derive national estimates of the prevalence of women diagnosed with uterine fibroids and associated symptom burden. Weighted means and percentages were reported. Prevalence across age and ethnic groups was examined. Symptom burden among women with and without uterine fibroids was compared using weighted logistic regressions. RESULTS: Of 59,411 respondents who met study inclusion criteria, 7.7% reported receiving a diagnosis of uterine fibroids. Of these, 5,670 women (1,402 in the uterine fibroid group and 4,268 in the control group) were excluded from analysis because they had a hysterectomy. Among the non-hysterectomized study participants, 3,031 self-reported a diagnosis of uterine fibroids (prevalence: 5.8%, 95% confidence interval [CI]: 5.5%-6.1%); prevalence increased as women aged and was greatest in the 50-54 age group (11.4%; 95% CI: 10.4%-12.4%). In addition, prevalence was greater in black vs white women (9.8%; 95% CI: 8.7%-11.0% vs 5.4%; 95% CI: 5.1%-5.7%). A greater percentage of women with uterine fibroids (vs those without) experienced severe heavy menstrual bleeding (16.7% vs 7.7%), severe constipation/bloating/diarrhea (7.7% vs 4.7%), severe passage of clots (6.7% vs 2.4%), severe spotting/bleeding between periods (1.7% vs 1.0%), and severe pelvic pressure (1.6% vs 0.6%). Among uterine fibroid patients with these typical uterine fibroid-related symptoms, 56.4%, 32.3%, 26.4%, 25.8%, and 20.4% reported heavy menstrual bleeding, passage of clots, spotting/bleeding between periods, constipation/bloating/diarrhea, and pelvic pressure, respectively, as extremely bothersome. CONCLUSION: Uterine fibroids impose a heavy burden on women aged 18-54 years in the US.

Prevalence and Symptomatic Burden of Diagnosed Endometriosis in the United States: National Estimates from a Cross-Sectional Survey of 59,411 Women.

BACKGROUND/AIMS: To estimate the prevalence of diagnosed endometriosis (DE) in women in the United States and assess the associated symptomatic burden. METHODS: An online, cross-sectional survey of women aged 18-49 years was conducted from August 6, 2012, through November 14, 2012. Survey data (weighted by age, race, education, income, geographical distribution, and propensity score) were used to estimate the prevalence and symptomatic burden of DE in women in the United States. Weighted logistic regressions were used to assess differences in symptom burden between women with and without endometriosis. RESULTS: The prevalence of DE was estimated at 6.1% (2,922 of 48,020 women surveyed); 52.7% of women were 18-29 years of age when they were diagnosed with endometriosis. Most (86.2%) women experienced symptoms before diagnosis. More women with (vs. without) DE had menstrual pelvic pain/cramping (52.7 vs. 45.2%), non-menstrual pelvic pain/cramping (36.7 vs. 14.3%), infertility (11.6 vs. 3.4%), and dyspareunia (29.5 vs. 13.4%). Women with endometriosis were also more likely to report severe symptoms (OR (95% CI) 2.7 (2.3-3.1) for menstrual pelvic pain/cramping, 2.2 (1.7-2.9) for non-menstrual pelvic pain/cramping, and 2.4 (1.8-3.2) for dyspareunia). CONCLUSION: The prevalence of DE among US women is notable, and affected women experience a substantial symptom burden.

Temporal trends and predictors of salvage cancer treatment after failure following radical prostatectomy or radiation therapy: an analysis from the CaPSURE registry.

BACKGROUND: Prostate cancer treatment after failure of primary therapy by either radical prostatectomy or radiation therapy can vary greatly. This study sought to determine trends and predictors of salvage treatment after failure of primary treatment in a community cohort over the past 10 years. METHODS: From the community-based Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) database, 6275 patients were identified who initiated a form of primary treatment for prostate cancer; 839 of these were identified as failing treatment by biochemical recurrence or initiation of secondary treatment between 2000 and 2010. Salvage therapy was categorized as either systemic, local, or none. Patient characteristics were tested for association with salvage therapy using analysis of variance, Pearson chi-square tests, and multinomial logistic regression analysis. RESULTS: Of the 839 patients identified as failing therapy, 390 (47%), 146 (17%), and 303 (36%) received systemic, local, or no salvage therapy, respectively. Type of primary treatment received was associated with type of salvage therapy (P < .01). There has been an increasing trend in the use of local salvage therapy over the past 10 years (P = .04). Primary treatment type and biopsy Gleason score were significantly associated with type of salvage therapy. CONCLUSIONS: The use of local salvage therapy has increased over the past decade, whereas the use of systemic salvage therapy has declined. Primary treatment is an important factor in determining which type of salvage therapy a patient will receive.

Patient demographics, quality of life, and disease features of men with newly diagnosed prostate cancer: trends in the PSA era.

OBJECTIVE: To describe how demographic and diagnostic characteristics of men with prostate cancer in the United States have changed since 1999, using data from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) registry. METHODS: The medical records of patients enrolled in CaPSURE between 1999 and 2011 were evaluated. Baseline demographics, disease features, and imaging use were assessed. Mantel-Haenszel chi-square was used to test for trends across diagnostic years. RESULTS: Between 1999 and 2011, a total of 9572 patients were diagnosed with prostate cancer and enrolled in CaPSURE at community (36), academic (3), and Veteran's Affairs (4) hospitals. Over the study period, mean age at diagnosis decreased, P <.01. In 2008-2011, a significant increase in diagnostic Gleason 7 or higher was observed relative to 1999-2001 (50% vs 36%, P <.01), congruent with recent guideline modifications of the Gleason classification system. An increase in the mean number of diagnostic biopsy cores (13.3 vs 8.3, P <.01) was also observed. A significant decrease in use of any imaging modality was seen (19% vs 45%, P <.01). Average pretreatment urinary and bowel function scores did not change, although there were significant increases in sexual function observed overall (P <.01). CONCLUSION: In the United States, several trends in the demographics and disease profile of men with newly diagnosed prostate cancer were observed over the past 12 years. Decreased imaging use and increased number of cores taken during diagnostic biopsy are in line with national urologic guidelines on prostate cancer diagnosis and management.

Chronic kidney disease in gout in a managed care setting.

BACKGROUND: To study the prevalence of chronic kidney disease (CKD) and its impact on allopurinol dosing and uric acid control among patients with gout. METHODS: This was a retrospective study using data from a large US health plan. Claims and laboratory data were analyzed for enrollees from the health plan database from January 2002 through December 2005. Patients with gout were identified from pharmacy and medical claims data based on the presence of codes for gout medication or gout diagnosis. Severity of CKD was determined using the estimated glomerular filtration rate (eGFR). Allopurinol titration was defined as a change in average daily dose from first prescription to last prescription of ≥ 50 mg. RESULTS: A total of 3,929 patients were identified for inclusion in this study, 39% of whom had CKD (based on having an eGFR < 90 mL/min/1.73 m2). Subjects with CKD were older (p < 0.01) and more likely to be women (p < 0.01), had a greater number of comorbid conditions (p < 0.01), and were more likely to be prescribed allopurinol (p < 0.01) compared to those with no CKD. The average starting dose of allopurinol was lower among those with CKD, and it decreased with worsening kidney function. Among the 3,122 gout patients who used allopurinol, only 25.6% without CKD and 22.2% with CKD achieved a serum uric acid concentration of < 6.0 mg/dL (p = 0.0409). Also, only 15% of allopurinol users had an upward dose titration (by ≥50 mg), but the average increase in dose did not differ significantly between those with and without CKD. CONCLUSIONS: About two out of every five patients with gout in this population had CKD. Allopurinol doses were not adjusted in the majority of CKD patients. Serum uric acid control in gout was poor among patients without CKD and even worse among those with CKD.

Add-back therapy use and its impact on LA persistence in patients with endometriosis.

OBJECTIVES: Persistence and compliance in women with endometriosis who are receiving gonadotropin-releasing hormone agonists (GnRH-a) may be limited by its hypoestrogenic side effects. Use of concomitant therapy with norethindrone acetate (NA), estrogen, estrogen/progestin combinations, or other progestin (i.e., 'add-back therapy' [ABT]) is recommended to alleviate these side effects. This retrospective study evaluated ABT utilization and its effect on compliance and persistence in patients with endometriosis taking the GnRH-a leuprolide acetate (LA) depot suspension. METHODS: A retrospective analysis of a large pharmacy claims database identified patients who started LA therapy from 2002 to 2004 for the treatment of endometriosis. Patients were identified as having received ABT if they started 7 days before, or within 45 days of the last LA fill. RESULTS: A total of 1285 women with endometriosis who began using LA were identified with 12 months of evaluable data: 211 (16.4%) used concomitant NA therapy, 116 (9.0%) used concomitant estrogen-based therapy, 28 (2.2%) used concomitant combination estrogen- and progestin-based therapies, 56 (4.4%) used concomitant progestin-based therapy, and 874 (68.0%) did not use any ABT. Mean (+/-SD) LA persistence in women receiving NA-based ABT was 5.83 +/- 2.98 months, compared with 4.25 +/- 2.62 months for those not using ABT (P < 0.0001). Average medication possession ratio was 0.43 +/- 0.20 for women receiving NA-based ABT versus 0.32 +/- 0.18 for those not receiving any ABT (P < 0.0001). Patients < 30 years of age were most likely to continue therapy longer and have greater compliance compared with the older age group cohorts (P < 0.01). Patients who used ABT continued to do so for 3.79 +/- 3.21 months. LIMITATIONS: Limitations of this study include those associated with the use of retrospective claims databases: It does not include any information regarding the patient's pain symptoms, disease severity, or other factors, which could correlate to compliance and persistence. CONCLUSIONS: Among women using LA therapy for endometriosis, only 32% used any type of ABT, and these patients had significantly higher persistence and compliance with LA therapy compared to no ABT user group.

Impact of noncompliance with urate-lowering drug on serum urate and gout-related healthcare costs: administrative claims analysis.

OBJECTIVE: To determine the association between allopurinol compliance and serum urate (sUA) level; and examine the association between sUA and gout-related healthcare costs in a large managed care population. RESEARCH DESIGN AND METHODS: This retrospective administrative claims analysis examined subjects with gout (> or = 2 medical claims with ICD-9-CM diagnosis code 274.xx or > or = 1 claim with a gout diagnosis and > or = 1 pharmacy claim for allopurinol, probenecid, colchicine, or sulfinpyrazone) between January 1, 2002 and March 31, 2004. Each subject was observed during 1-year pre-index and 1-year post-index periods. MAIN OUTCOME MEASURES: Outcomes were allopurinol medication possession ratio (MPR) and compliance (MPR > or = 0.80), sUA (mg/dL), and gout-related healthcare costs. 'Post-allopurinol' sUA was measured during three periods after the first observed allopurinol fill: 30-89 days; 90-149 days; > or = 150 days. A baseline sUA on or before the start of the post-index period was also identified. Outcomes were stratified by post-allopurinol or baseline sUA and compliance. Generalized linear modeling (GLM) regression measured the impact of baseline sUA on gout-related healthcare costs, controlling for demographic and health status variables. RESULTS: The study sample comprised 18,243 subjects with mean age of 53.9 years. In all, 55% (n = 10,073) of subjects used allopurinol. There were 1473 (8.1%) subjects with a post-allopurinol sUA and 2438 (13.4%) subjects with a baseline sUA result. Among all subjects with a post-allopurinol sUA, 45.6% were compliant; between 49.3% and 56.8% of compliant subjects had an sUA < 6.0 mg/dL compared with 22.5-27.8% of non-compliant subjects, depending on the post-allopurinol time period (all p < 0.001). GLM results showed gout-related costs associated with baseline sUA > or = 6.0 and < 9.0 mg/dL were 58% higher (95% confidence interval (CI): 1.012 -2.456; p = 0.044) than were costs for sUA < 6.0 mg/dL. There was no significant difference in gout-related costs between baseline sUA < 6.0 mg/dL and > or = 9.0 mg/dL. CONCLUSIONS: Analysis revealed an important associations between allopurinol compliance, sUA, and gout-related costs: compliance was positively associated with favorable sUA (<6.0 mg/dL) in unadjusted comparisons. GLM showed that baseline sUA < 6.0 was inversely associated with gout-related costs relative to baseline sUA > or = 6.0 and <9.0 mg/dL. Nevertheless, a substantial portion of subjects, even compliant ones, did not achieve sUA < 6.0 mg/dL. These results should be interpreted carefully in light of study limitations, including incomplete laboratory data, the potentially incorrect inference that medications were taken as prescribed, and lack of generalizability from Medicare managed care enrollees to the broader Medicare population.

The effect of serum urate on gout flares and their associated costs: an administrative claims analysis.

BACKGROUND: Increased serum urate (sUA) levels (> or =6.0 mg/dL) are associated with increased likelihood of acute gout attacks, or "flares." OBJECTIVES: Identify gout flares with administrative claims data; examine the relationship between sUA and flares; examine the association between sUA and flare-related costs. METHODS: This retrospective administrative claims analysis examined subjects with gout (> or =2 medical claims with ICD-9-CM diagnosis code 274.xx or > or =1 claim with a gout diagnosis and > or =1 pharmacy claim for allopurinol, probenecid, colchicine, or sulfinpyrazone) between January 1, 2002 and March 31, 2004. Each subject was observed during 1-year baseline and 1-year follow-up periods. Gout flares were identified with an algorithm using claims for services associated with flares. Outcomes were sUA (mg/dL) and flare-related health care costs. Logistic regression examined the likelihood of flare; generalized linear modeling regression measured the impact of baseline sUA on flare costs, controlling for demographic and health status variables. RESULTS: The study sample comprised 18,243 subjects with mean age of 53.9 years. sUA was available for 4277 (23%) subjects. Sixty-two percent (11,253) of subjects had > or =1 flare. The number of mean, unadjusted flares increased with sUA. Logistic results showed subjects with baseline sUA > or =6.0 relative to sUA <6.0 had 1.3 times the odds of gout flare (P <0.05). Generalized linear modeling results showed that baseline sUA > or =6.0 was associated with 2.1 to 2.2 times higher flare costs than was baseline sUA <6.0 (P <0.05). CONCLUSIONS: sUA was a significant predictor both of gout flare and related costs. This highlights the importance of gout management strategies aimed at controlling sUA.

Medication compliance and persistence: terminology and definitions.

OBJECTIVE: The aim of the study is to provide guidance regarding the meaning and use of the terms "compliance" and "persistence" as they relate to the study of medication use. METHODS: A literature review and debate on appropriate terminology and definitions were carried out. RESULTS: Medication compliance and medication persistence are two different constructs. Medication compliance (synonym: adherence) refers to the degree or extent of conformity to the recommendations about day-to-day treatment by the provider with respect to the timing, dosage, and frequency. It may be defined as "the extent to which a patient acts in accordance with the prescribed interval, and dose of a dosing regimen." Medication persistence refers to the act of continuing the treatment for the prescribed duration. It may be defined as "the duration of time from initiation to discontinuation of therapy." No overarching term combines these two distinct constructs. CONCLUSIONS: Providing specific definitions for compliance and persistence is important for sound quantitative expressions of patients' drug dosing histories and their explanatory power for clinical and economic events. Adoption of these definitions by health outcomes researchers will provide a consistent framework and lexicon for research.