Design and powering of cystic fibrosis clinical trials using pulmonary exacerbation as an efficacy endpoint.

BACKGROUND: Reduction in pulmonary exacerbations is an important efficacy endpoint for CF clinical studies. Powering exacerbation endpoints requires estimation of the future exacerbation incidence in CF study populations, but rates differ across the population. METHODS: We have estimated exacerbation rates for Epidemiologic Study of CF subpopulations stratified by age, FEV(1)% predicted, sex, weight-for-age percentile, respiratory signs and symptoms, and history of exacerbation and bacterial culture. Sample sizes required to attain 80% power to detect exacerbation reductions of 20% to 80% in 1:1 randomized studies of 3 to 12 month duration were determined. Exacerbation treatments with "any" antibiotic (new oral quinolone, new inhaled antibiotic, or intravenous (IV) antibiotic) and with IV antibiotics were studied. RESULTS: At all ages, decreased FEV(1), female sex, exacerbation history, and Pseudomonas aeruginosa culture history were associated with increased treatment for exacerbation. CONCLUSIONS: These data should assist investigators in the design of future CF exacerbation studies.

Design and powering of cystic fibrosis clinical trials using rate of FEV(1) decline as an efficacy endpoint.

BACKGROUND: Rate of lung function decline (RLFD) (as FEV(1) percent predicted/yr) is a robust measure of CF therapeutic efficacy rarely used as a study endpoint, in part due to uncertainty of sample size requirements. METHODS: Sample size requirements for 1:1 randomizations to detect RLFD treatment effects from 20% to 80% were assessed in Epidemiologic Study of CF (ESCF) patients. Effects of measuring FEV(1) 1-4 times per year in studies of 1- to 4-year durations were assessed in 399 patients age ≥ 6 years with FEV(1) ≥ 70%. Impacts of inclusion/exclusion based on risk factors in 2369 ESCF patients were assessed over 1.5 years using semi-annual FEV(1) measures. RESULTS: Increasing study duration and exclusion of lower risk patients (e.g., no P. aeruginosa infection) both substantially reduced requirements. CONCLUSIONS: CF RLFD studies of 1.5 years in duration appear feasible provided that investigators account for the beneficial effects of subject inclusion/exclusion based on risk factors in power estimates.

Gout Assessment Questionnaire: Initial results of reliability, validity and responsiveness.

We evaluated the psychometric properties of a new gout-specific patient reported outcomes questionnaire. The Gout Assessment Questionnaire (GAQ) and the SF-36 were administered to 126 subjects in a multicenter Phase II program of febuxostat, an investigational treatment for hyperuricemia (serum uric acid >8.0 mg/dl) in patients with chronic gout. The questionnaire was administered at baseline and 1, 6 and 12 months later. The majority of subjects, mean age 54 years, were male, Caucasian and had experienced a gout flare within the last year. Seven domains were identified, all met criteria for reliability and validity. Cronbach's alpha ranged from 0.78 to 0.97. Pearson correlations between GAQ and SF-36 scales were generally low to moderate, with the highest correlation between Gout Pain and Severity and SF-36 Bodily Pain, r = 0.45. Guyatt's statistic (measure of responsiveness) ranged from 0.24 to 1.00 at 12 months. Minimal clinically important differences ranged from 2 (Gout Concern) to 10 points (Productivity). The GAQ has acceptable psychometric properties. Further research is required to confirm results, which may provide more information to improve the GAQ for use in clinical trials.

TENOR risk score predicts healthcare in adults with severe or difficult-to-treat asthma.

The aim of the present study was to predict which patients with severe or difficult-to-treat asthma are at highest risk for healthcare utilisation can be predicted so as to optimise clinical management. Data were derived from 2,821 adults with asthma enrolled in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study. Multiple potential predictors were assessed at baseline using a systematic algorithm employing stepwise logistic regression. Outcomes were asthma-related hospitalisations or emergency department (ED) visits within 6 months following baseline. Overall, 239 subjects (8.5%) reported hospitalisation or ED visits at follow-up. Predictors retained after multivariate analysis were as follows: younger age; female sex; non-white race; body mass index > or =35 kg x m(-2); post-bronchodilator per cent predicted forced vital capacity <70%; history of pneumonia; diabetes; cataracts; intubation for asthma; and three or more steroid bursts in the prior 3 months. A final risk score derived from the logistic regression model ranged from 0-18 and was highly predictive (c-index: 0.78) of hospitalisation or ED visits. This tool was re-tested in a prospective validation using outcomes at 12- to 18-months follow-up among the same cohort (c-index: 0.77). The risk score derived is a clinically useful tool for assessing the likelihood of asthma-related hospitalisation or emergency department visits in adults with severe and difficult-to-treat asthma.

Health-Related quality-of-life and quality-days incrementally gained in symptomatic nonerosive GERD patients treated with lansoprazole or ranitidine.

Eight-hundred forty-nine patients with symptomatic nonerosive GERD from two clinical trials of lansoprazole 15 mg daily (LAN 15) and lansoprazole 30 mg daily (LAN 30) vs ranitidine 150 mg twice a day (RAN 150) completed a health-related quality-of-life (HRQoL) questionnaire at baseline and four and eight weeks after treatment. The questionnaire included the Short-Form 12, GERD symptoms, eating symptoms, social restrictions, problems with sleep, work disability, treatment satisfaction, and associated importance weights items. Both LAN groups reported greater, although not significant, improvement from baseline to week 8 versus RAN 150 in the majority of HRQoL scales. Treatment satisfaction was significantly higher at week 8 in both LAN groups. Quality-days incrementally gained analysis showed that both LAN groups gained significantly more quality days than RAN 150. Patients taking lansoprazole 15 or 30 mg daily reported better outcomes than those receiving ranitidine 150 twice a day over the eight-week study.

The association between socioeconomic status, health insurance coverage, and quality of life in men with prostate cancer.

The objective of this study was to examine the effect of socioeconomic status and insurance status on health-related quality of life (HRQOL) outcomes in men with prostate cancer. The design was a retrospective cohort study using multiple sites, including both academic and private practice settings. A cohort of 860 men with newly diagnosed, biopsy-proven prostate cancer of any stage was identified within CaPSURE, a longitudinal disease registry of prostate cancer patients. HRQOL was assessed with validated instruments, including the RAND 36-item Health Survey (SF-36) and the UCLA Prostate Cancer Index. Covariates included insurance status, education level, annual income, age, stage, comorbidity, Gleason grade, baseline PSA, marital status, ethnicity and primary treatment. HRQOL measurements were taken at 3-6-month intervals. Analysis of covariance was used to determine the effect of SES and insurance status on the HRQOL domains at baseline and over time. Patients with lower annual income had significantly lower baseline HRQOL scores in the all of the domains of the SF-36 and four of eight disease-specific HRQOL domains. No relationship was seen between annual income and HRQOL outcomes over time. Conversely, health insurance status was associated with HRQOL over time, but not at baseline. Health insurance status appears to have a unique effect on general HRQOL outcomes in men after treatment for prostate cancer. This study confirms the commonly held belief that patients of lower SES tend to have worse quality of life at baseline and following treatment for their disease. These findings have important ramifications for clinicians, researchers and policy makers.

Quality of life before death for men with prostate cancer: results from the CaPSURE database.

PURPOSE: We examined changes in health related quality of life during the 12 months before death in men with prostate cancer. MATERIALS AND METHODS: We studied patients from CapSure, which is a longitudinal observational cohort of men with biopsy proved prostate cancer treated in community and academic urology practices across the United States. Of all men in the cohort who died while being followed for prostate cancer 131 who had submitted health related quality of life surveys during the 6 months before death were included in this analysis. Health related quality of life was measured with the RAND 36-Item Health Survey, an established validated instrument that comprises 4 physical and 4 mental domains. RESULTS: On univariate analysis all 8 domains of the 36-Item Health Survey substantially decreased in the final year of life. On multivariate analysis only physical function decreased more rapidly in men dying of prostate cancer compared to those dying of other cancer or benign causes. CONCLUSIONS: Quality of life begins a steady and inexorable decline in the final 12 months of life in men with prostate cancer. Increased attention to quality of life changes may provide new clinical opportunities to enhance quality of care in the final year of life in these men.

Motivational antecedents to contraceptive method change following a pregnancy scare: a couple analysis.

In this study we develop and then test a couple model of contraceptive method choice decision-making following a pregnancy scare. The central constructs in our model are satisfaction with one's current method and confidence in the use of it. Downstream in the decision sequence, satisfaction and confidence predict desires and intentions to change methods. Upstream they are predicted by childbearing motivations, contraceptive attitudes, and the residual effects of the couples' previous method decisions. We collected data from 175 mostly unmarried and racially/ethnically diverse couples who were seeking pregnancy tests. We used LISREL and its latent variable capacity to estimate a structural equation model of the couple decision-making sequence leading to a change (or not) in contraceptive method. Results confirm most elements in our model and demonstrate a number of important cross-partner effects. Almost one-half of the sample had positive pregnancy tests and the base model fitted to this subsample indicates less accuracy in partner perception and greater influence of the female partner on method change decision-making. The introduction of some hypothesis-generating exogenous variables to our base couple model, together with some unexpected findings for the contraceptive attitude variables, suggest interesting questions that require further exploration.

Urinary function and bother after radical prostatectomy or radiation for prostate cancer: a longitudinal, multivariate quality of life analysis from the Cancer of the Prostate Strategic Urologic Research Endeavor.

PURPOSE: We measure the effect of time on urinary function and bother during the first 2 years following treatment for early stage prostate cancer. MATERIALS AND METHODS: We studied urinary function and bother in 564 men recently diagnosed with early stage prostate cancer and treated with radiotherapy or radical prostatectomy with or without nerve sparing. Outcomes were assessed with the UCLA Prostate Cancer Index, which is a validated, health related quality of life instrument that includes these 2 domains. To minimize the influence of other factors we adjusted for age, co-morbidity, general health, pad use, anticholinergics or procedures for urethral stricture. All subjects were drawn from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), which is a national longitudinal database. RESULTS: Urinary function improved with time during the first year after surgery but remained fairly constant during year 2. Urinary function remained stable throughout the 2 years after radiation. Urinary bother was worse after radiation throughout the 2 years, although it improved markedly by the end of year 1. Age, ethnicity and co-morbidity did not impact urinary function or bother but being married did have an advantage. CONCLUSIONS: Patients undergoing surgery or radiation showed different longitudinal profiles of urinary function and bother during the first 2 years after treatment.

A comparison of patient and partner responses to a brief sexual function questionnaire.

PURPOSE: Patient self-administered questionnaires have recently been developed to assess sexual function in men with erectile dysfunction. However, it may also be important to assess satisfaction with and any improvements in sexual function from the perspective of the female partner. We report the results of a brief 3-item questionnaire developed for the female partner and its association with an 11-item questionnaire developed for men with erectile dysfunction. MATERIALS AND METHODS: Men and their female partners each self-administered a brief sexual function questionnaire several times during a clinical trial of an experimental treatment for erectile dysfunction. Items addressed the frequency and firmness of erection, and satisfaction with sex life on a 5-point Likert scale with responses ranging from 0 to 4. We compared mean values of the 3 items common to each questionnaire by respondent, and also analyzed item and scale correlations using weighted kappa statistics and/or the Pearson correlation coefficient. RESULTS: Data from 389 pairs were available. Generally patient results were fairly consistent with those of partners. Men reported slightly more frequent erection (1.6 versus 1.5), identical firmness of erection (1.2) and less satisfaction (1.2 versus 1.4) than partners. Weighted kappas of the 3 items ranged from 0.47 to 0.61, representing good agreement. The Pearson correlations were slightly higher. Internal consistency reliability using Cronbach's alpha of the 3-item scale was 0.69 (0.77 for patient and 0.81 for partner). CONCLUSIONS: These data support the use of patient and partner assessments of sexual function in clinical trials of erectile dysfunction.

Sexual function and bother after radical prostatectomy or radiation for prostate cancer: multivariate quality-of-life analysis from CaPSURE. Cancer of the Prostate Strategic Urologic Research Endeavor.

OBJECTIVES: To measure the effect of treatment choice (pelvic irradiation [XRT] versus radical prostatectomy [RP] with or without nerve sparing) on sexual function and sexual bother during the first 2 years after treatment. METHODS: We studied sexual function and sexual bother in 438 men recently diagnosed with early-stage prostate cancer and treated with XRT or RP with or without nerve sparing. Outcomes were assessed with the University of California, Los Angeles Prostate Cancer Index, a validated health-related quality-of-life instrument that includes these two domains. To minimize the influence of other factors, we adjusted for age, comorbidity, general health, and previous treatment for erectile dysfunction. All subjects were drawn from CaPSURE, a national, longitudinal data base. RESULTS: Sexual function improved over time during the first year in all treatment groups; however, during the second year, sexual function began to decline in the XRT group. Older patients who received XRT showed substantial declines in sexual function throughout the 2 years, and older patients who underwent RP experienced a return of very low baseline sexual function. Sexual function was improved by the use of nerve-sparing procedures or erectile aids. Alterations in sexual bother were ameliorated by many factors, including age, general health perceptions, and sexual function. CONCLUSIONS: Patients undergoing XRT or RP with or without nerve sparing all showed comparable rates of improvement in sexual function during the first year after treatment for early-stage prostate cancer. However, in the second year after treatment, patients treated with XRT began to show declining sexual function; patients treated with RP did not.

Development of a health-related quality-of-life questionnaire for individuals with gastroesophageal reflux disease: a validation study.

This study was conducted to test the psychometric properties of a newly developed health-related quality-of-life (HRQoL) questionnaire. A total of 172 symptomatic GERD patients completed a 57-item questionnaire (containing the SF-12; symptom frequency/bothersomeness; problems related to activities, sleep, work disability; overall HRQoL; and treatment satisfaction) at baseline, week 1 [retest (N = 25)], and week 4 [follow-up (N = 100)]. Internal-consistency reliability was acceptable for most scales (range: 0.74-0.92). Test-retest reliability was acceptable for most scales (ICC: 0.74-0.85). Construct validity was demonstrated based on observed correlations. Known-groups validity was upheld, as patients who experienced more symptom days and patients who reported higher pain reported worse HRQoL than those with less symptoms or less severe pain. When categorized according to change in pain severity, Guyatt's statistic for the "improved" and "worse" groups demonstrated responsiveness, although many of the scales for the "stable" group were also responsive. In conclusion, the HRQoL questionnaire was found to be reliable, valid, and responsive.

A comparison of two approaches for assessing patient importance weights to conduct an Extended Q-TWiST analysis.

OBJECTIVE: Patient-centered methods for evaluating treatments require validated preference-elicitation techniques. We describe the validation of two preference-elicitation approaches for use in an Extended Q-TWiST treatment evaluation. The first method was an "idiographic" approach, which attempts to capture intra-individual differences in the degree to which each domain distracted from and interfered with life activities. The second method, a Likert-scaled approach, asks patients to evaluate the importance of each quality-of-life (QOL) domain. METHODS: Patient-reported QOL and preferences were assessed in participants with gastroesophageal reflux disease at baseline (n = 172), one week (n = 25), and 4 weeks after baseline (n = 100). RESULTS: Both approaches demonstrated high internal consistency and the ability to discriminate known groups based on reported pain and number of days with symptoms. The idiographic approach exhibited responsiveness, although it was more highly correlated with QOL than the Likert-scaled approach. The Likert-scaled approach had good face validity but demonstrated low reliability compared to the idiographic approach. CONCLUSIONS: Both preference-elicitation methods exhibited promise as well as limitations. Future research should focus on increasing the reliability of the Likert-scaled approach, reducing the overlap between the idiographic approach and QOL, and examining the relationship between reliability and responsiveness for a range of illness trajectories.

Probabilistic sensitivity analysis incorporating the bootstrap: an example comparing treatments for the eradication of Helicobacter pylori.

Decision-analytic models are frequently used to evaluate the relative costs and benefits of alternative therapeutic strategies for health care. Various types of sensitivity analysis are used to evaluate the uncertainty inherent in the models. Although probabilistic sensitivity analysis is more difficult theoretically and computationally, the results can be much more powerful and useful than deterministic sensitivity analysis. The authors show how a Monte Carlo simulation can be implemented using standard software to perform a probabilistic sensitivity analysis incorporating the bootstrap. The method is applied to a decision-analytic model evaluating the cost-effectiveness of Helicobacter pylori eradication. The necessary steps are straightforward and are described in detail. The use of the bootstrap avoids certain difficulties encountered with theoretical distributions. The probabilistic sensitivity analysis provided insights into the decision-analytic model beyond the traditional base-case and deterministic sensitivity analyses and should become the standard method for assessing sensitivity.

Approaches to missing data inference results from CaPSURE: an observational study of patients with prostate cancer.

OBJECTIVE: There are multiple reasons for missing data in observational studies; excluding patients with missing data can lead to significant bias. In this study, we evaluated several methods for assigning missing values to health service utilisation. DESIGN AND SETTING: Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) is a US national database of men with prostate cancer. Physician visits and diagnostic tests for 342 patients newly diagnosed with prostate cancer were evaluated. PATIENTS AND PARTICIPANTS: Patients were followed for a full year (observed data, n = 228) and patients with incomplete data (predicted data, n = 114) were included. INTERVENTIONS: We used the following approaches for imputing missing data: assigning the group mean, a time-specific mean, a patient-specific mean, a stratified mean (by age, localised disease and insurance status) and carrying the last observation forward and/or backward. MAIN OUTCOME MEASURES AND RESULTS: All prediction strategies resulted in higher estimates (19.3 to 23.1) for annual physician visits than was observed (17.1 +/- 15.5), and differences were statistically significant for both the last observation carried forward (23.1 +/- 15.5) and the patient's individual mean (22.7 +/- 36.1) when predicting physician visits. The same strategies had higher predicted values for x-rays (1.8 +/- 5.1 and 1.8 +/- 4.4 vs 1.1 +/- 1.9 for the observed group), although the last observation carried forward was not statistically different from the observed value. CONCLUSIONS: We were unable to identify a single optimal strategy. However, imputation from individual means and the last observation carried forward methods did not perform as well as the other strategies. While the differences observed in this study were small, we anticipate that with increased length of follow-up and more dropouts, there would be greater differences among strategies.

Dopamine receptor genes are associated with age at first sexual intercourse.

The dopaminergic system in the brain seems to play an important role in the regulation of sexual behaviour. The relationship between genes for the D1, D2 and D4 dopamine receptors and age at first sexual intercourse (AFSI) was examined in a sample of 414 non-Hispanic, European-American men and women. A significant association was observed between a DRD2 allele and AFSI and an even stronger association when the DRD2 allele was interacted with a DRD1 allele. A constrained regression model was constructed predicting AFSI using sex and a group of nine psychosocial variables as predictors. Adding the DRD2 and the DRD2-by-DRD1 predictors to this model increased the explained variance by 23 and 55%, respectively. Although these findings suggest a stronger association among males than among females, further research will be necessary to clarify this question, as well as to establish whether the observed association holds in other racial/ethnic groups.

PIP: The dopaminergic system in the brain appears to play an important role in regulating sexual behavior. Specifically, findings to date suggest a major role for dopaminergic receptors in both the preparatory and consummatory phase of male sexual behavior, while its role in female sexual behavior is less conclusive. Findings also indicate that the D(2) subtype of dopamine receptor plays a key role in the control of male sexual behavior, although a D(1) and D(2) subtype interaction is suggested. The relationship between genes for the D(1), D(2), and D(4) dopamine receptors and age at first sexual intercourse (AFSI) was examined in a sample of 414 non-Hispanic, European-American, middle-class, married men and women in Santa Clara County, California. The men and women were of mean ages 31.6 and 29.6 years, respectively. A significant association was found between the DRD2 allele and AFSI, and an even stronger association when the DRD2 allele was interacted with a DRD1 allele. A constrained regression model was constructed predicting AFSI using sex and a group of 9 psychosocial variables as predictors. Adding the DRD2 and the DRD2-by-DRD1 predictors to the model increased the explained variance by 23% and 55%, respectively. While these findings suggest a stronger association among males than among females, further research is needed, as well as to establish whether the observed association holds in other racial/ethnic groups.

A health-related quality-of-life instrument for symptomatic patients with endometriosis: a validation study.

OBJECTIVE: This study was designed to evaluate the reliability, validity, and responsiveness of a newly developed, health-related quality-of-life measure. STUDY DESIGN: A total of 137 women (122 from a Phase III clinical trial and 15 from a private practice setting) with endometriosis completed the questionnaire several times. RESULTS: Reproducibility and internal-consistency reliability were acceptable with intraclass correlation coefficients ranging from 0.94 to 1.00 and Cronbach's alpha coefficients ranging from 0.84 to 0.97. Construct validity was demonstrated on the basis of correlations between items and scales. Health-related quality of life varied in a consistent manner according to clinician-rated measures of pelvic pain and dysmenorrhea and patient-reported levels of endometriosis pain, but no relationship emerged according to the revised American Fertility Society classification. In general, the questionnaire was moderately to highly responsive to change. CONCLUSION: This is the first comprehensive health-related quality-of-life questionnaire available for use with endometriosis patients that has demonstrated reliability, validity, and responsiveness.

Epidemiological trends and financial outcomes in radical prostatectomy among Medicare beneficiaries, 1991 to 1993.

PURPOSE: We define epidemiological trends in radical prostatectomy among Medicare beneficiaries in the United States, describe related financial reimbursement to hospitals and physicians, and determine how many men received adjuvant therapy with androgen ablation or pelvic irradiation from 1991 to 1993. MATERIALS AND METHODS: We examined radical prostatectomy claims from a national 5% simple random sample (688,000 men) of 1991, 1992 and 1993 data on Medicare beneficiaries from the Health Care Financing Administration. We determined rates of radical prostatectomies among patients stratified by age, race and geographical region, and measured the fraction of men who had claims submitted for postoperative therapies for prostate cancer. We also collected financial information for Medicare parts A and B to estimate federal government economic burden from radical prostatectomy in this population. RESULTS: Among the 5,016 patients identified with Medicare claims for radical prostatectomy during 1991 to 1993 the rate peaked at 284/100,000 men in 1992 before declining the next year. For the youngest Medicare beneficiaries the rate increased 233% from 1991 to 1992 and 156% from 1992 to 1993. White men had a higher rate than nonwhite men in all 3 years but only in nonwhite men did the rate continue to rise during the study period. Geographical variations greater than 2-fold were noted. Total Medicare expenditures for radical prostatectomy were $194.2 million in 1991, $277.8 million in 1992 and $230.8 million in 1993. During 1991 to 1993 hospitals received more than three-fourths of total Medicare payments for radical prostatectomy, while physicians received less than one-fourth. More than 23% of men undergoing radical prostatectomy received subsequent therapy with gonadotropin releasing hormone agonists, bilateral orchiectomy and/or pelvic irradiation within 3 years of radical prostatectomy. CONCLUSIONS: Radical prostatectomy represents a significant burden on the federal health care dollar and does not appear to be as definitively curative as expected.

Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine.

PURPOSE: To compare pain-related treatment satisfaction, patient-perceived side effects, functioning, and well-being in patients with advanced cancer who were receiving either transdermal fentanyl (Duragesic, Janssen Pharmaceuticals, Titusville, NJ) or sustained-release oral forms of morphine (MS Contin, Perdue Frederick Co, Norwalk, CT, or Oramorph SR, Roxanne Laboratories, Columbus, OH). PATIENTS AND METHODS: A total of 504 assessable cancer patients participated in this cross-sectional, quality-of-life study. Relevant elements of four validated scales were used--the Functional Assessment of Cancer Therapy-General (FACT-G) scale, the Brief Pain Inventory (BPI), the Medical Outcomes Study (MOS) questionnaire, and the Memorial Symptom Assessment Scale (MSAS)--as well as original scales that were developed and validated for this study. RESULTS: The majority of patients in both treatment groups had late-stage (IV/D) cancer. Patients who received transdermal fentanyl were more satisfied overall with their pain medication than those who received sustained-release oral forms of morphine (P = .035). Fentanyl patients also experienced a significantly lower frequency (P < .002) and impact (P < .001) of pain medication side effects. These results occurred despite the fact that cancer patients who received fentanyl were significantly older (P < .001) and had significantly lower functioning and well-being scores (P = .001). Measures of pain intensity, sleep adequacy, and symptoms demonstrated no significant differences between treatment groups. CONCLUSION: These data suggest that patients are more satisfied with transdermal fentanyl compared with sustained-release oral forms of morphine. A lower frequency and reduced impact of side effects with transdermal fentanyl may be one reason cancer patients who receive fentanyl are more satisfied with their pain management.

Quality of life, health care utilization, and costs among women undergoing hysterectomy in a managed-care setting.

OBJECTIVE: We compared quality of life, utilization, and costs for women undergoing elective abdominal, laparoscopically assisted vaginal, or vaginal hysterectomy within a managed-care organization. STUDY DESIGN: A prospective study of 287 women who underwent an elective hysterectomy was performed. RESULTS: Patients undergoing a vaginal hysterectomy reported returning to normal activity levels sooner and had more favorable quality-of-life scores than did those undergoing laparoscopically assisted vaginal hysterectomy or abdominal hysterectomy. Laparoscopically assisted vaginal hysterectomy was often nearly as favorable as vaginal hysterectomy, particularly at 28 days after the operation, whereas the abdominal hysterectomy group consistently reported the poorest postoperative quality-of-life scores. No significant differences were noted in utilization or costs in the 60-day preoperative period, whereas hospitalization and postoperative costs were highest among the abdominal hysterectomy group and lowest for those undergoing a vaginal hysterectomy. CONCLUSIONS: Vaginal hysterectomy resulted in better quality-of-life outcomes and lower utilization and costs compared with laparoscopically assisted vaginal or abdominal hysterectomy.