Development and validation of the revised Cedars-Sinai health-related quality of life for rheumatoid arthritis instrument.

OBJECTIVE: To improve accuracy and content coverage of the original 33-item Cedars-Sinai Health-Related Quality of Life for Rheumatoid Arthritis Instrument (CSHQ-RA). METHODS: A total of 312 RA patients from 55 sites were screened in a 24-week trial. Patients completed an expanded 48-item version of the CSHQ-RA, Medical Outcomes Study Short Form 36 (MOS SF-36), and Stanford Health Assessment Questionnaire (HAQ) Disability Index at 5 visits. The revised CSHQ-RA was created based on response frequencies and distributions, item-to-item correlation, factor and Rasch analysis, and input from experts. Psychometric evaluation included internal consistency, test-retest reliability, convergent and discriminant validity, and responsiveness. Minimum clinically important difference (MCID) was also measured. RESULTS: Response rates were 93% at baseline and 71% at 12 weeks. Eighty-one percent of respondents at baseline were women, mean +/- SD age was 52 +/- 12 years, and mean +/- SD duration of RA was 10.8 +/- 10.4 years. The revised CSHQ-RA included 36 items measuring 7 domains (4 original and 3 new). All Cronbach's alpha coefficients were >0.8, indicating good internal consistency. Test-retest reliability measured intraclass correlation coefficients, which ranged from 0.86 to 0.95. All 7 domains correlated significantly with the MOS SF-36 and HAQ, indicating good convergent validity. Analysis of variance of disability group scores showed good discriminant validity (P < 0.0001). The MCIDs ranged from 6.2 for social well-being to 14.8 for pain/discomfort. CONCLUSION: The revised CSHQ-RA was validated using a broader RA patient population. It captures 3 additional domains (social well-being, pain/discomfort, and fatigue), which allow for measuring all important aspects of health-related quality of life.

Validation of a rheumatoid arthritis health-related quality of life instrument, the CSHQ-RA.

OBJECTIVE: To test the validity and reliability of a newly developed disease-specific multidimensional quality of life instrument: the Cedars-Sinai Health-Related Quality of Life Instrument (CSHQ-RA). METHODS: A total of 350 rheumatoid arthritis (RA) patients were asked to complete the CSHQ-RA at 2 time points (4 weeks apart). Patients also completed the Medical Outcomes Study Short Form 36 (SF-36) and the Stanford Health Assessment Questionnaire (HAQ) Disability Index (DI) at the second time point. Construct validity was tested, using Pearson's correlations, by comparing subscale scores on the CSHQ-RA to those obtained from the mental component summary (MCS) and physical component summary (PCS) of the SF-36. HAQ DI scores were used to assess the discriminant validity of the CSHQ-RA. Intraclass correlation coefficients (ICCs) were used to assess test-retest reliability. RESULTS: Response rates for the first and second survey were 83% (291) and 93% (276), respectively; 84% of respondents were women, and mean age was 57 years. Mean scores +/- SDs on instruments were: HAQ 0.73 +/- 0.69; MCS 49 +/- 12; and PCS 33 +/- 11. Pearson's correlations between the CSHQ-RA subscale scores and the SF-36 scores ranged from 0.55 to 0.76 (P < 0.001). Analysis of variance indicate that scores on the CSHQ-RA discriminated between levels of physical disability as measured by the HAQ (P < 0.001). Test-retest reliability was demonstrated in the instrument's subscale scores (ICC 0.70-0.90). CONCLUSION: These results support the construct validity, discriminant validity, and reliability of the CSHQ-RA as a measure that captures the impact of RA on patients' health-related quality of life.

Health-related quality of life in men with metastatic prostate cancer: the misleading effect of lead-time bias.

OBJECTIVE: To ascertain whether the difference in health-related quality of life, which appears to be worse in men with metastatic prostate cancer when the metastases are noted at initial diagnosis than during follow-up after treatment for clinically localized disease, can be attributed to previous local control or to some form of measurement bias. PATIENTS AND METHODS: We analysed by univariate and multivariate methods 375 men with metastatic prostate cancer who were enrolled in CaPSURE, a national observational cohort of patients with prostate cancer treated in community and academic settings throughout the USA. In particular, we assessed whether group differences in health-related quality of life were explained by the timing of metastatic diagnosis in the course of their disease. Health-related quality of life was measured with the RAND 36-Item Health Survey (SF-36). RESULTS: After controlling for relevant covariates (age, comorbidity and ethnicity), multivariate models suggested that men whose metastases were noted at the time of initial diagnosis scored 5-15 points worse in all eight domains of the SF-36. CONCLUSION: Men who are diagnosed with metastatic prostate cancer during the follow-up after treatment for clinically localized disease report a better quality of life than those who are metastatic at the time of diagnosis, not because the primary treatment confers any benefit but because they are followed more closely over time and diagnosed with metastases earlier in the course of their disease. This apparent difference in quality of life is an effect of lead-time bias in the diagnosis of metastasis.

Health related quality of life differences between black and white men with prostate cancer: data from the cancer of the prostate strategic urologic research endeavor.

PURPOSE: Understanding the potential consequences of racial differences in prostate cancer outcomes, from survival rates to quality of life considerations, is important for the clinician and patient. We examined demographic, clinical and health related quality of life data comparing black with white patients just after treatment of prostate cancer and 1 year later. MATERIALS AND METHODS: We analyzed data on 1,178 patients who were newly diagnosed with prostate cancer in the Cancer of the Prostate Strategic Urologic Research Endeavor, a national observational database of men recruited from 35 community and academic urology practices throughout the United States. Patient demographics, clinical characteristics and validated health related quality of life questionnaires were reviewed. A total of 958 white and 161 black patients with prostate cancer who completed at least 2 surveys were compared. RESULTS: The black patients were younger, and had lower income and education levels than white patients. Controlling for age, education and income differences, black patients generally had worse clinical characteristics at presentation and lower baseline health related quality of life data scores in most generic and disease specific categories at treatment. The most notable exception was sexual function, which was the only score that was higher in black patients at treatment. With time, health related quality of life improved in both groups but black patients had slower rates of improvement for general health, bodily pain, physical function, role function, disease worry and bowel function. They continued to have higher sexual function. CONCLUSIONS: Significant differences exist in clinical presentation, sociodemographic characteristics, and health related quality of life between black and white men with prostate cancer. These health related quality of life differences remain after treatment. Physicians should not assume that outcomes in black men would be similar to other patients.

A review of the direct costs of rheumatoid arthritis: managed care versus fee-for-service settings.

Rheumatoid arthritis (RA) is a prevalent condition associated with pain, joint destruction and morbidity. Direct healthcare costs are 2 to 3 times higher than average costs for individuals of similar age and gender. Furthermore, utilisation and costs rise with age and disease duration. Managed care has become an increasingly popular way to organise and finance the delivery of healthcare. Studies comparing the quality of care in health maintenance organisations and fee-for-service settings have found few differences in outcomes, although reduced costs have been attributed to lower hospitalisation rates in patients with RA. We reviewed 10 studies of the direct costs of RA. In 1996 dollars, direct costs ranged from $US 2,299 per person per year in Canada to $US 13,549 in a US study focusing on patients who have been hospitalised only. Surprisingly, the contributions to direct costs--hospital care, medications and physician visits--remained relatively stable over time and the setting of care. Hospitalisation costs were the highest component of direct costs accounting, generally, for 60% or more of costs while only approximately 10% of patients with RA were hospitalised. The only exception was a managed care setting where hospitalisation costs were 16% of total direct costs. In managed care settings, costs of medications were proportionately higher than in fee-for-service settings. We conclude that in studies of the direct costs of RA the components of costs have remained relatively stable over time. This may change with the development and growing use of new RA medications including cyclo-oxygenase 2 inhibitors, interleukins, cytokines, treatments that inhibit tumour necrosis factor, and combination therapies. The effectiveness of managed care in controlling direct costs needs to be evaluated in more targeted studies.

Predicting risk of prostate specific antigen recurrence after radical prostatectomy with the Center for Prostate Disease Research and Cancer of the Prostate Strategic Urologic Research Endeavor databases.

PURPOSE: Biostatistical models to predict stage or outcome in patients with clinically localized prostate cancer with pretreatment prostate specific antigen (PSA), Gleason sum on biopsy or prostatectomy specimen, clinical or pathological stage and other variables, including ethnicity, have been developed. However, to date models have relied on small subsets from academic centers or military populations that may not be representative. Our study validates and updates a model published previously with the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE, UCSF, Urology Outcomes Research Group and TAP Pharmaceutical Products, Inc.), a large multicenter, community based prostate cancer database and Center for Prostate Disease Research (CPDR), a large military database. MATERIALS AND METHODS: We validated a biostatistical model that includes pretreatment PSA, highest Gleason sum on prostatectomy specimen, prostatectomy organ confinement status and ethnicity, including white and black patients. We then revised it with the Cox regression analysis of the combined 503 PSA era surgical cases from the CPDR prospective cancer database and 1,012 from the CaPSURE prostate cancer outcomes database. RESULTS: The original equation with 3 risk groups stratified CaPSURE cases into distinct categories with 7-year disease-free survival rates of 72%, 42.1% and 27.6% for low, intermediate and high risk men, respectively. Parameter estimates obtained from a Cox regression analysis provided a revised model equation that calculated the relative risk of recurrence as: exponent (exp)[(0.54 x Race) + (0.05 x sigmoidal transformation of PSA [PSA(ST)]) + (0.23 x Postop Gleason) + (0.69 x Pathologic stage). The relative risk of recurrence, as calculated by the aforementioned equation, was used to stratify the cases into 4 risk groups. Very low-4.7 or less, low-4.7 to 7.1, high-7.1 to 16.7 and very high-greater than 16.7, and patients at risk had 7-year disease-free survival rates of 85.4%, 66.0%, 50.6% and 21.3%, respectively. CONCLUSIONS: With a broad cohort of community based, academic and military cases, we developed an equation that stratifies men into 4 discrete risk groups of recurrence after radical prostatectomy and confirmed use of a prior 3 risk group model. Although the variables of ethnicity, pretreatment PSA, highest Gleason sum on prostatectomy specimen and organ confinement status on surgical pathology upon which the model is based are easily obtained, more refined modeling with additional variables are needed to improve prediction of intermediate risk in individuals.

The effect of androgen deprivation therapy on health-related quality of life in men with prostate cancer.

Treatment for prostate cancer has a significant impact on health-related quality of life (HRQOL). We examined HRQOL in a cohort of men receiving androgen deprivation therapy (ADT) and a cohort who opted for surveillance. The cohort consisted of 1178 newly diagnosed patients from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) database (a national longitudinal registry of patients with prostate cancer). General and disease-specific HRQOL outcomes were measured with validated instruments (the SF-36 and University of California at Los Angeles [UCLA] Prostate Cancer Index) at study entry and quarterly thereafter. Individuals were grouped by initial treatment: ADT, surveillance, radical prostatectomy, or radiation therapy. There were 106 men who selected surveillance, 167 men receiving ADT, 351 men treated by radical prostatectomy, and 75 men receiving radiation therapy in the first year after diagnosis. Mean age at diagnosis was 73 years of age, with surveillance patients the oldest and radical prostatectomy patients the youngest. Men receiving ADT reported poorer urinary and sexual function and a higher rate of urinary and sexual bother than patients selecting surveillance. ADT and surveillance HRQOL scores remained low (ie, poorer function) in the year after treatment, whereas men undergoing radical prostatectomy showed improvement in these scales. Patients who received ADT had reduced energy, poorer sexual and urinary function, and were more bothered by their urine and sexual function than patients undergoing other treatments, except surveillance. Longer follow-up time after start of ADT and surveillance is needed to discern the impact of comorbidities on HRQOL.

Androgen deprivation therapy for patients with clinically localized (stages T1 to T3) prostate cancer and for patients with biochemical recurrence after radical prostatectomy.

Recently published studies suggest a benefit for androgen deprivation therapy (ADT) delivered early in the course of prostate cancer. However, the use of ADT specifically in patients with clinically localized disease or biochemical-disease recurrence after local therapy is not well defined. Potential candidates for primary ADT include patients who are poor candidates for definitive local therapy because of advanced age or comorbid conditions, as well as patients with significant local disease who refuse standard therapy. Treatment strategies designed to minimize the side effects of prolonged therapy, such as intermittent ADT or antiandrogen monotherapy, show promise as alternatives to continuous ADT in some patients. The role of ADT in patients with clinically localized and recurrent prostate cancer, whether it is delivered in a continuous or intermittent fashion, must be determined in randomized, prospective trials.

Psychometric validation of the O'leary-Sant interstitial cystitis symptom index in a clinical trial of pentosan polysulfate sodium.

The O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) has been proposed as a treatment outcome measure in interstitial cystitis (IC). The psychometric properties of the ICSI were assessed for reliability and validity in a randomized, double-blind clinical study of 300, 600, and 900 mg daily dose of pentosan polysulfate sodium (PPS) in patients with IC. The ICSI contains 4 items that measure urgency and frequency of urination, nighttime urination, and pain or burning. The ICSI index score is the sum of the item scores (range: 0-20). ICSI scores were obtained at baseline, 4, 8, 12, 16, 24, and 32 weeks of treatment. Patients' overall ratings of improvement of symptoms (PORIS) scores evaluating improvements in pain, urgency, and overall IC symptoms were also collected except at baseline. A total of 376 patients were included in the analysis. Psychometric properties evaluated included variability (range), test-retest reliability (intraclass correlation coefficient [ICC]), internal consistency (the Cronbach alpha), construct validity (convergent, discriminant), responsiveness, and clinically meaningful change. The ICSI items and index score had good variability and test-retest reliability. The ICSI demonstrated internal consistency reliability and was responsive to change. Participants indicating a 75% improvement in PORIS had a 48% mean reduction in the ICSI score, while participants reporting 100% improvement in PORIS had a 77% mean reduction in the ICSI score. The ICSI is a valid, reliable, and responsive measure of change in IC symptoms. This outcome measure should be utilized in future treatment outcomes studies in IC.

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.

Under staging and under grading in a contemporary series of patients undergoing radical prostatectomy: results from the Cancer of the Prostate Strategic Urologic Research Endeavor database.

PURPOSE: We determined the prevalence of under staging and under grading in contemporary patients undergoing radical prostatectomy in academic and community based urology practices, and defined important predictors of under staging in this population. MATERIALS AND METHODS: We compared clinical T stage and biopsy Gleason score with pathological T stage and prostatectomy Gleason score in 1,313 patients enrolled in the Cancer of the Prostate Strategic Urologic Research Endeavor database, a longitudinal registry of patients with prostate cancer, who underwent radical prostatectomy, including 53% since 1995. Under grading was determined for the primary and secondary Gleason patterns and defined as a biopsy Gleason pattern of 1 to 3 that became pathological Gleason pattern 4 or 5. Under staging was defined as a clinically organ confined tumor that was extraprostatic stages pT3 to 4 or N+ at radical prostatectomy. Univariate and multivariate analysis was performed to determine important risk factors for under staging and significant risk factors were used to identify the likelihood of under staging in clinically relevant patient subgroups. The importance of the percent of positive biopsies in regard to the likelihood of under staging was determined by assigning patients to previously described risk groups based on serum prostate specific antigen (PSA) at diagnosis and biopsy Gleason score. RESULTS: Under grading of primary and secondary Gleason patterns occurred in 13% and 29% of patients, respectively, while under staging occurred in 24%. Univariate and multivariate analysis revealed that PSA at diagnosis, biopsy Gleason score and the percent of positive biopsies were significant predictors of under staging. The percent of positive biopsies appeared to be most important for predicting the likelihood of extraprostatic disease extension in intermediate or high risk disease based on serum PSA at diagnosis and biopsy Gleason grade. CONCLUSIONS: The prevalence of under grading and under staging in contemporary patients undergoing radical prostatectomy may be lower than previously reported. PSA at diagnosis, biopsy Gleason score and the percent of positive biopsies are important predictors of under staging. The percent of positive biopsies should be incorporated into risk assessment models of newly diagnosed prostate cancer.

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.

An instrument to measure patient satisfaction with healthcare in an observational database: results of a validation study using data from CaPSURE.

OBJECTIVE: To validate a satisfaction measure for use in longitudinal, prospective studies of patient care. STUDY DESIGN: Patients with biopsy-confirmed prostate cancer (n = 228) who were enrolled in CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) completed a self-administered questionnaire that included a health-related quality-of-life and satisfaction measure. A subset of patients completed the questionnaire again within 30 days. METHODS: The satisfaction measure contained 6 individual subscales: overall satisfaction with care, contact with providers, confidence in providers, communication skills, humaneness, and a summary scale. Six items surveyed patients' willingness to participate in decision making (participatory style), and these were averaged into a single score. Variability, reliability, stability, and validity were evaluated. RESULTS: Responses to the items varied substantially. The overall satisfaction scale demonstrated good internal consistency reliability (Cronbach alpha = 0.82) and moderate test-retest reliability (0.62), and it could discriminate between groups of individuals expected to differ with regard to satisfaction (by age and disease stage). Subscale internal consistency reliability (0.37-0.54) and stability (0.38-0.63) were weaker, suggesting that only a single scale should be reported. The participatory scale performed poorly and could not be recommended for future use. CONCLUSION: The overall satisfaction measure developed for this study demonstrated good reliability and validity and should be useful in other population-based studies in conjunction with other outcome measures.

Patterns of treatment of patients with prostate cancer initially managed with surveillance: results from The CaPSURE database. Cancer of the Prostate Strategic Urological Research Endeavor.

PURPOSE: We determined the demographic and clinical profile of men who elect surveillance as the initial management of prostate cancer as well as the incidence and predictors of secondary treatment of these patients. MATERIALS AND METHODS: The Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE) is a national disease registry of patients with various stages and treatments of prostate cancer. Using this database of 4,458 men we identified 329 (8.2%) who elected surveillance as the initial management of prostate cancer. Patients choosing watchful waiting were compared to other CaPSURE participants using the chi-square test. The likelihood of treatment initiation in the watchful waiting group was calculated using the Kaplan-Meier method. After adjusting for patient age, race, prostate specific antigen (PSA) at diagnosis, clinical T stage and total Gleason score the Cox proportional hazards regression model was used to determine significant predictors of treatment initiation. RESULTS: Compared with others in the database, patients on watchful waiting were more likely to be 75 years old or older (51% versus 16%, p <0.001), white (93% versus 85%, p <0.001), and have lower serum PSA (p <0.001), organ confined disease (97% versus 88%, p <0.001) and a total Gleason score of 7 or less (97% versus 88%, p <0.001). In the watchful waiting group there was a 52% likelihood of treatment initiation within 5 years of the diagnosis. Significant predictors of secondary treatment were age younger than 65 years and elevated serum PSA at diagnosis. Neither race, extraprostatic stage cT3 disease nor higher total Gleason score was a significant predictor of treatment. CONCLUSIONS: Men who elect initial watchful waiting for prostate cancer tend to be older, have lower serum PSA and more favorable disease characteristics than those who seek treatment. PSA at diagnosis is the dominant factor for predicting secondary treatment.

Quantifying comorbidity in a disease-specific cohort: adaptation of the total illness burden index to prostate cancer.

OBJECTIVES: Numerous studies have demonstrated the importance of comorbid illness when analyzing medical outcomes. The purpose of this study was to adapt a generic comorbidity index, the Total Illness Burden Index (TIBI), for use in men with prostate cancer, and to evaluate the usefulness of the new instrument in adjusting for the impact of comorbidity on functional outcomes in a prostate cancer cohort. METHODS: The TIBI uses patients' self-report of symptoms and diagnoses to determine not only the presence but also the severity of comorbidities in each of 16 body system domains. To create the TIBI-P (prostate cancer modification), some domains were added and others were modified according to clinical criteria. The TIBI-P was completed by 1638 men with prostate cancer followed up longitudinally in 29 urology practices in the United States. TIBI-P scores were calculated for each patient and analyzed with scores on the SF-36 quality-of-life questionnaire and with patient report of days confined to bed. RESULTS: After adjusting for age and income, lower SF-36 scale scores and increases in confinement to bed were associated with a greater burden of comorbid illness as measured by the TIBI-P, independent of the extent of prostate cancer. The TIBI-P explained 24% of the variance in the SF-36 physical functioning domain score. CONCLUSIONS: The TIBI-P is a powerful measure of the impact of comorbid illness on the quality of life and functioning among patients with prostate cancer. This index may prove valuable in research on clinical and economic outcomes of prostate cancer.

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.

A health related quality of life measure for use in patients with urge urinary incontinence: a validation study.

OBJECTIVE: Urge incontinence has substantial impact on health related quality of life (HRQOL). The purpose of this research was to test the psychometric properties of the Urge-Incontinence Impact Questionnaire (U-IIQ) and Urge-Urinary Distress Inventory (U-UDI). METHODS: The U-IIQ and the U-UDI were incorporated in a single arm study of an investigational once-a-day formulation of oxybutynin (Ditropan XL) for urge incontinence. The U-IIQ contains 7 scales scored separately: Travel, Activities, Physical activities, Feelings, Relationships, Sexual function and Nighttime bladder control. We also calculated a single index score. The U-UDI contains 9 items summarized in a single score that measures the extent to which incontinence symptoms bother patients and an urge symptoms summary score. Patients completed the questions at: start of baseline week, end of baseline week, week 4 and week 12 (final dose). RESULTS: The questions were completed by the 257 patients enrolled in the study (91% female, mean age = 60 years). All item responses showed good variability. Internal-consistency reliability was very good (Cronbach's alpha = 0.82-0.96). Test-retest reliability was good for all scales ([ICC] = 0.68-0.83). Discriminant validity was noted for all scales for patients with and without frequent incontinence (p < or = 0.006 all scales). All scales demonstrated responsiveness to change over time (Guyatt's statistic = magnitude of -1.04 - magnitude of -1.71). CONCLUSIONS: Psychometric testing indicated that the scales measured distinct and relevant domains of HRQOL for patients with urge incontinence, and that these two instruments are reliable, valid, and responsive to change in this condition.

A health-related quality of life measure for use in patients with onychomycosis: a validation study.

Onychomycosis is a common nail disorder associated with pain, discomfort and varying degrees of physical impairment and loss of dexterity. Psychological and social limitations result from reactions of others to visible impairment. The goal of this research is to validate a questionnaire to measure the impact of toenail onychomycosis on health-related quality of life (HRQoL). One hundred and fifty onychomycosis patients were enrolled in an observational study at eight sites in the US. Attending physicians reported information on clinical status at enrolment. Patients completed a questionnaire covering HRQoL that included general and disease-specific items measuring the impact of onychomycosis on activities and appearance, plus problems and symptoms associated with toenail infection. The subscales of the instrument showed high internal consistency reliability (range = 0.63-0.95). Construct validity reflected the close association of physical functioning scores with onychomycosis impairment. Test-Retest reliability was good to excellent for all scales (ICC = 0.52-0.89). Discriminant validity was evidenced by persons who are younger and female reporting worse disease-specific HRQoL. Responsiveness to clinical change was noted for all disease-specific scale scores for improved patients. This instrument has demonstrated reliability, validity and responsiveness for use in observational and clinical studies of toenail onychomycosis patients. Data indicate that onychomycosis patients report significant pain and discomfort reflecting the need for HRQoL measurement.

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.

Changes in health-related quality of life in the first year after treatment for prostate cancer: results from CaPSURE.

OBJECTIVES: Treatment for prostate cancer has a significant impact on health-related quality of life (HRQOL). We examined HRQOL immediately after diagnosis and treatment and 1 and 2 years after treatment for a cohort of men with early and late-stage prostate cancer. METHODS: We studied 692 men enrolled in CaPSURE, a large national observational data base of patients with prostate cancer. General and disease-specific HRQOL were measured with validated instruments at study entry and quarterly thereafter. Individuals were grouped by initial treatment: radical prostatectomy, radiotherapy, hormonal therapy, and observation (ie, no treatment in first year). Trends in HRQOL scores were evaluated immediately after treatment through 2 years, adjusting for age and length of follow-up. RESULTS: Patients who underwent radical prostatectomy demonstrated statistically significant increases in functioning in general and in disease-specific components during the year after treatment when compared with scores immediately after treatment. Patients receiving radiotherapy and hormonal therapy had significant improvements in patient reports of health change during the year. CONCLUSIONS: Patients undergoing radical prostatectomy have low HRQOL scores just after treatment in almost all general and disease-specific areas, but at 1 year there is a sharp improvement. Patients undergoing observation, radiotherapy, or hormonal therapy remain stable over time. All treatment groups continue to have decrements in sexual function.