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PurposeThe long-term effects of neoadjuvant androgen deprivation therapy (NADT) with radiation therapy on participant-reported health-related quality of life (HRQOL) have not been characterized in prospective multicenter studies. We evaluated HRQOL for 2 years among participants undergoing radiation therapy (RT) with or without NADT for newly diagnosed, early-stage prostate cancer.Methods and materialsWe analyzed longitudinal cohort data from the Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium to ascertain the HRQOL trajectory of men receiving NADT with external beam RT (EBRT) or brachytherapy. HRQOL was measured using the expanded prostate cancer index composite 26-item questionnaire at 2, 6, 12, and 24 months after the initiation of NADT. We used the χ2 or Fisher exact test to compare the shift in percentages between groups that did or did not receive NADT. Analyses were conducted at the 2-sided 5% significance level.ResultsFor subjects receiving EBRT, questions regarding the ability to have an erection, ability to reach an orgasm, quality of erections, frequency of erections, ability to function sexually, and lack of energy were in a significantly worse dichotomized category for the patients receiving NADT. Comparing the baseline versus 24-month outcomes, 24%, 23%, and 30% of participants receiving EBRT plus NADT shifted to the worse dichotomized category for the ability to reach an orgasm, quality of erections, and ability to function sexually compared with 14%, 13%, and 16% in the EBRT group, respectively.ConclusionsCompared with baseline, at 2 years, participants receiving NADT plus EBRT compared with EBRT alone had worse HRQOL, as measured by the ability to reach orgasm, quality of erections, and ability to function sexually. However, no difference was found in the ability to have an erection, frequency of erections, overall sexual function, hot flashes, breast tenderness/enlargement, depression, lack of energy, or change in body weight. The improved survival in intermediate- and high-risk patients receiving NADT and EBRT necessitates pretreatment counseling of the HRQOL effect of NADT and EBRT.

To establish validity for the Pelvic Floor Disorders Network (PFDN) self-administered Adaptive Behavior Index (ABI) and to assess whether ABI assesses known discordance between severity of pelvic floor symptoms and self-reported bother.In addition to the ABI questionnaire, participants in 1 of 6 Pelvic Floor Disorders Network trials completed condition-specific measures of pretreatment symptom severity (including Pelvic Floor Distress Inventory; PFDI) and health-related quality of life (Pelvic Floor Impact Questionnaire; PFIQ). The final survey was developed from an iterative process using subject and expert endorsement, factor analyses, and response distributions. Domains were created using a development cohort (n = 304 women), reliability and validity were established using a validation cohort (n = 596 women), and test-retest reliability was assessed (n = 111 women).Factor analyses supported an 11-item avoidance domain and a 6-item hygiene domain. Cronbach' alphas were 0.88 and 0.68, respectively. Test-retest reliability was 0.84 for both domains. Construct validity was demonstrated in correlations between the ABI domains and baseline PFDI and PFIQ (r values, 0.43-0.79 with all P values

PurposeHarms of prostate cancer treatment on urinary health related quality of life have been thoroughly studied. In this study we evaluated not only the harms but also the potential benefits of prostate cancer treatment in relieving the pretreatment urinary symptom burden.Materials and methodsIn American (1,021) and Spanish (539) multicenter prospective cohorts of men with localized prostate cancer we evaluated the effects of radical prostatectomy, external radiotherapy or brachytherapy in relieving pretreatment urinary symptoms and in inducing urinary symptoms de novo, measured by changes in urinary medication use and patient reported urinary bother.ResultsUrinary symptom burden improved in 23% and worsened in 28% of subjects after prostate cancer treatment in the American cohort. Urinary medication use rates before treatment and 2 years after treatment were 15% and 6% with radical prostatectomy, 22% and 26% with external radiotherapy, and 19% and 46% with brachytherapy, respectively. Pretreatment urinary medication use (OR 1.4, 95% CI 1.0-2.0, p = 0.04) and pretreatment moderate lower urinary tract symptoms (OR 2.8, 95% CI 2.2-3.6) predicted prostate cancer treatment associated relief of baseline urinary symptom burden. Subjects with pretreatment lower urinary tract symptoms who underwent radical prostatectomy experienced the greatest relief of pretreatment symptoms (OR 4.3, 95% CI 3.0-6.1), despite the development of deleterious de novo urinary incontinence in some men. The magnitude of pretreatment urinary symptom burden and beneficial effect of cancer treatment on those symptoms were verified in the Spanish cohort.ConclusionsMen with pretreatment lower urinary tract symptoms may experience benefit rather than harm in overall urinary outcome from primary prostate cancer treatment. Practitioners should consider the full spectrum of urinary symptom burden evident before prostate cancer treatment in treatment decisions.

PurposeWe examined the relationship between glycemic control and urinary tract infections in women with type 1 diabetes mellitus.Materials and methodsWomen enrolled in the Epidemiology of Diabetes Interventions and Complications study, the observational followup of the Diabetes Control and Complications Trial, were surveyed to assess the rate of physician diagnosed urinary tract infections in the preceding 12 months. The relationship between glycated hemoglobin levels and number of urinary tract infections in the previous 12 months was assessed using a multivariable Poisson regression model.ResultsA total of 572 women were evaluated at year 17. Mean age was 50.7 ± 7.2 years, mean body mass index was 28.6 ± 5.9 kg/m(2), mean type 1 diabetes duration was 29.8 ± 5.0 years and mean glycated hemoglobin was 8.0% ± 0.9%. Of these women 86 (15.0%) reported at least 1 physician diagnosed urinary tract infection during the last 12 months. Higher glycated hemoglobin levels were significantly associated with number of urinary tract infections such that for every unit increase (1%) in recent glycated hemoglobin level, there was a 21% (p=0.02) increase in urinary tract infection frequency in the previous 12 months after adjusting for race, hysterectomy status, urinary incontinence, sexual activity in the last 12 months, peripheral and autonomic neuropathy, and nephropathy.ConclusionsThe frequency of urinary tract infections increases with poor glycemic control in women with type 1 diabetes. This relationship is independent of other well described predictors of urinary tract infections and suggests that factors directly related to glycemic control may influence the risk of lower urinary tract infections.

ObjectiveTo establish a score threshold that constitutes a clinically relevant change for each domain of the Expanded Prostate Cancer Index Composite (EPIC) Short Form (EPIC-26). Although its use in clinical practice and clinical trials has increased worldwide, the clinical interpretation of this 26-item disease-specific patient-reported quality of life questionnaire for men with localized prostate cancer would be facilitated by characterization of score thresholds for clinically relevant change (the minimally important differences [MIDs]).MethodsWe used distribution- and anchor-based approaches to establish the MID range for each EPIC-26 domain (urinary, sexual, bowel, and vitality/hormonal) based on a prospective multi-institutional cohort of 1201 men treated for prostate cancer between 2003 and 2006 and followed up for 3 years after treatment. For the anchor-based approach, we compared within-subject and between-subject score changes for each domain to an external "anchor" measure of overall cancer treatment satisfaction.ResultsWe found the bowel and vitality/hormonal domains to have the lowest MID range (a 4-6 point change should be considered clinically relevant), whereas the sexual domain had the greatest MID values (10-12). Urinary incontinence appeared to have a greater MID range (6-9) than the urinary irritation/obstruction domain (5-7).ConclusionUsing 2 independent approaches, we established the MIDs for each EPIC-26 domain. A definition of these MID values is essential for the researcher or clinician to understand when changes in symptom burden among prostate cancer survivors are clinically relevant.

ObjectivesTo assess the impact of ambulatory surgery centers (ASCs) on rates of hospital-based outpatient procedures and adverse events.Data sourcesTwenty percent national sample of Medicare beneficiaries.Study designA retrospective study of beneficiaries undergoing outpatient surgery between 2001 and 2010. Health care markets were sorted into three groups-those with ASCs, those without ASCs, and those where one opened for the first time. Generalized linear mixed models were used to assess the impact of ASC opening on rates of hospital-based outpatient surgery, perioperative mortality, and hospital admission.Principal findingsAdjusted hospital-based outpatient surgery rates declined by 7 percent, or from 2,333 to 2,163 procedures per 10,000 beneficiaries, in markets where an ASC opened for the first time (p  .4 for test between slopes).ConclusionsThe opening of an ASC in a Hospital Service Area resulted in a decline in hospital-based outpatient surgery without increasing mortality or admission. In markets where facilities opened, procedure growth at ASCs was greater than the decline in outpatient surgery use at their respective hospitals.

BackgroundOutpatient surgery is increasingly delivered at freestanding ambulatory surgery centers (ASCs), which are thought to deliver quality care at lower costs per episode. The objective of this study was to understand potential facilitators and/or barriers to the introduction of freestanding ASCs in the United States.MethodsThis is an observational study conducted from 2008 to 2010 using a 20% sample of Medicare claims. Potential determinants of ASC dissemination, including population, system, and legal factors, were compared between markets that always had ASCs, never had ASCs, and those that had new ASCs open during the study. Multivariable logistic regression was used to determine characteristics of markets associated with the opening of a new facility in a previously naïve market.ResultsNew ASCs opened in 67 previously naïve markets between 2008 and 2010. ASCs were more likely to open in hospital service areas that were urban (adjusted odds ratio [OR], 4.10; 95% confidence interval [CI], 1.51-10.96), had higher per capita income (adjusted OR, 3.83; 95% CI, 1.43-10.45), and had less competition for outpatient surgery (adjusted OR, 2.13; 95% CI, 1.02-4.45). Legal considerations and latent need, as measured by case volumes of hospital-based outpatient surgery in 2007, were not associated with the opening of a new ASC.ConclusionsFreestanding ASCs opened in advantageous socioeconomic environments with the least amount of competition. Because of their associated efficiency advantages, policy makers might consider strategies to promote ASC diffusion in disadvantaged markets to potentially improve access and reduce costs.

AimsThe Michigan Incontinence Symptom Index (M-ISI) is a validated measure for urinary incontinence. This study evaluates the M-ISI as a screening tool for clinically relevant urinary incontinence in a population-based sample of women.MethodsThe Establishing the Prevalence of Incontinence (EPI) Study is a case-control, population-based study that enrolled women ages 35-64, with and without urinary incontinence. The M-ISI is a validated questionnaire with subdomains for stress and urgency urinary incontinence. Two hundred fourteen EPI subjects underwent a clinical evaluation and urodynamic testing to establish the presence and type of urinary incontinence, and also completed the M-ISI. The M-ISI scores were evaluated using receiver operating characteristic (ROC) curves to determine the optimal diagnostic threshold scores above which women were likely to have clinically relevant urinary incontinence.ResultsThe optimal M-ISI diagnostic threshold scores were determined to be ≥ 3 for the stress urinary incontinence subdomain (area under the curve of 0.79), ≥ 5 for the urgency urinary incontinence subdomain (area under the curve of 0.88), and ≥ 7 for the Total M-ISI score (area under the curve of 0.89). The sensitivity and specificity of the M-ISI questionnaire for stress, urgency, and total urinary incontinence were 77% and 73%, 86% and 76%, and 84% and 75%, respectively.ConclusionsThe M-ISI may be used to screen for clinically relevant urinary incontinence with high sensitivity and specificity among women ages 35-64. A brief, self-administered tool such as the M-ISI can help health care providers identify and manage women with urinary incontinence.

BackgroundThere has been a strong push to move outpatient surgery from hospital settings to ambulatory surgery centers (ASCs). Despite the efficiency advantages of ASCs, many are concerned that these facilities could increase overall utilization.ObjectiveTo assess the impact of ASC opening on rates of outpatient surgery.DesignThis was a retrospective cohort study of Medicare beneficiaries undergoing outpatient surgery between 2001 and 2010. We compared population-based rates of outpatient surgery in Hospital Service Areas (HSAs) with freestanding ASCs to those without. After adjusting for differences using multiple propensity score methods, we assessed the impact of ASC opening in an HSA previously without one on rates of outpatient surgery.SubjectsPatients included were Medicare beneficiaries with Part B eligibility.Main outcome measureAdjusted HSA-level rates of outpatient surgery.ResultsAdjusted outpatient surgery rates increased from 2806 to 3940 per 10,000 and the number of ASC operating rooms grew from 7036 to 11,223 (both P

AimsTo develop a clinically relevant, easy to use, and validated instrument for assessing severity and bother related to urinary incontinence.MethodsSurvey items were piloted and refined following psychometric principles in five separate patient cohorts. Patient and expert endorsement of items, factor analyses, Spearman rank correlations and response distributions were employed for item selection. Formal reliability and validity evaluation were conducted for the final questionnaire items.ResultsExpert physicians and patient focus groups confirmed face and content validity for the measure. A 10-item measure called the Michigan Incontinence Symptom Index (M-ISI) was developed with two domains: a Total M-ISI Domain consisting of subdomains for stress urinary incontinence, urgency urinary incontinence, and pad use, and a Bother Domain. High construct validity was demonstrated with a Cronbach's alpha for the Total M-ISI Domain (items 1-8) of 0.90 and for the Bother Domain (items 9-10) of 0.82. Cronbach's alpha for the subdomains were all > 0.85. Construct validity, convergent and divergent validity, internal discriminant validity, and predictive validity were all robust. The minimally important difference for the measure was determined to be 4 points (out of 32) for the Total M-ISI Severity Domain, and 1-2 points (out of 8-12) for the individual subdomains.ConclusionsThe M-ISI is a parsimonious measure that has established reliability and validity on several levels and complements current clinical evaluative methods for patients with urinary incontinence.

ObjectiveTo determine the effect of an ambulatory surgery center (ASC) opening in a healthcare market on utilization and quality of outpatient urologic surgery.MethodsThis is a retrospective cohort study of Medicare beneficiaries undergoing outpatient urologic surgery from 2001 to 2010. Markets were classified into 3 groups based on ASC status (ie, those with ASCs, those without ASCs, and those where ASCs were introduced). Multiple propensity score methods adjusted for differences between markets and general linear mixed models determined the effect of ASC opening on utilization and quality, defined by mortality and hospital admission within 30 days of the index procedure.ResultsDuring the study period, 195 ASCs opened in markets previously without one. Rates of hospital-based urologic surgery in markets where ASCs were introduced declined from 221 to 214 procedures per 10,000 beneficiaries in the 4 years after baseline. In contrast, rates in the other 2 market types increased over the same period (P.5).ConclusionThe introduction of an ASC into a healthcare market lowered rates of outpatient urologic surgery performed in the more expensive hospital setting. This redistribution was not associated with declines in quality or with greater growth in overall outpatient surgery use.

PurposeAfter being diagnosed with prostate cancer men must assimilate information regarding the cancer. Satisfaction with information reflects the evaluation of information sources used before treatment to select a therapy. We describe the use and helpfulness of several information sources available to prostate cancer survivors. We also identified factors associated with satisfaction with information.Materials and methodsA total of 1,204 men with newly diagnosed prostate cancer were enrolled in the prospective, multicenter Prostate Cancer Outcomes and Satisfaction with Therapy Quality Assessment study. The validated satisfaction with information domain of the Service Satisfaction Scale-Cancer was administered to subjects 2 months after treatment. The relationship between several factors, such as demographics, socioeconomic factors, cancer severity and types of information sources, and satisfaction with information were evaluated using multiple regression.ResultsSources of information endorsed by subjects varied by race, education and study site. The most helpful sources were treatment description by the treating physician (33.1%), Internet sites (18.9%) and books (18.1%). In multiple variable models patient age (p = 0.005) and information provided by the physician regarding outcomes in their patients (p = 0.01) were independently associated with patient satisfaction with the information provided.ConclusionsVarious information sources were used and endorsed as helpful by subjects, although results for physician patients was the only source independently associated with satisfaction with information. Providing patients with information about possible or expected courses of care and outcomes may improve satisfaction.

PurposeWe expanded the clinical usefulness of EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) by evaluating its responsiveness to health related quality of life changes, defining the minimally important differences for an individual patient change in each domain and applying it to a sexual outcome prediction model.Materials and methodsIn 1,201 subjects from a previously described multicenter longitudinal cohort we modeled the EPIC-CP domain scores of each treatment group before treatment, and at short-term and long-term followup. We considered a posttreatment domain score change from pretreatment of 0.5 SD or greater clinically significant and p ≤ 0.01 statistically significant. We determined the domain minimally important differences using the pooled 0.5 SD of the 2, 6, 12 and 24-month posttreatment changes from pretreatment values. We then recalibrated an EPIC-CP based nomogram model predicting 2-year post-prostatectomy functional erection from that developed using EPIC-26.ResultsFor each health related quality of life domain EPIC-CP was sensitive to similar posttreatment health related quality of life changes with time, as was observed using EPIC-26. The EPIC-CP minimally important differences in changes in the urinary incontinence, urinary irritation/obstruction, bowel, sexual and vitality/hormonal domains were 1.0, 1.3, 1.2, 1.6 and 1.0, respectively. The EPIC-CP based sexual prediction model performed well (AUC 0.76). It showed robust agreement with its EPIC-26 based counterpart with 10% or less predicted probability differences between models in 95% of individuals and a mean ± SD difference of 0.0 ± 0.05 across all individuals.ConclusionsEPIC-CP is responsive to health related quality of life changes during convalescence and it can be used to predict 2-year post-prostatectomy sexual outcomes. It can facilitate shared medical decision making and patient centered care.

ObjectiveTo evaluate the immediate effects of neoadjuvant androgen deprivation therapy (NADT) on health-related quality of life (HRQOL) among patients undergoing radiation therapy (RT) for newly diagnosed prostate cancer.MethodsThe Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium is a prospective multi-institutional study. HRQOL is measured with the Expanded Prostate Cancer Index Composite-26 questionnaire. Differences in patient-reported HRQOL were observed between pretreatment and 2 months after NADT start (and before definitive RT) with significant differences evaluated by paired t test.ResultsFrom among 450 patients who completed the Expanded Prostate Cancer Index Composite-26 before and 2 months after NADT start, 71 received NADT before proceeding with definitive RT. Patients receiving NADT experienced significant impairment in vitality/hormonal (P

ObjectivesTo assess trends in the use of sacral neuromodulation and to measure the magnitude of variation in its use across geographic regions.MethodsWe used the State Ambulatory Surgery Database (SASD) from 2002 to 2009 from Florida to identify patients implanted with a neuromodulator. Age- and gender-adjusted rates of implantation were calculated by year and by geographic region, defined by the Hospital Service Area. The coefficient of variation was estimated to quantify the magnitude of variation for different time periods.ResultsAdjusted rates of sacral neuromodulation increased significantly from 1.1 per 100,000 population in 2002 to 10.4 per 100,000 population in 2009. The majority of cases were performed for overactive bladder. There was a very large amount of geographic variation in rates of these procedures as evidenced by the high coefficients of variation: 1.67 (2002 and 2003), 1.70 (2004 and 2005), 1.49 (2006 and 2007), and 1.05 (2008 and 2009).ConclusionsRates of sacral neuromodulation have increased dramatically over the past decade. However, these rates of utilization are highly variable across regions, with some regions performing large numbers of these procedures and other regions performing few to no procedures. This range in practice patterns may reflect medical uncertainty surrounding the role of this procedure.

ObjectiveTo assess the effectiveness of mesh compared with nonmesh slings placed in different surgical settings as measured by the frequency of complications within 1 year.MethodsWe performed a retrospective cohort study of Medicare beneficiaries undergoing sling surgery from 2006 to 2008 in hospital outpatient departments and hospital-based ambulatory surgery centers. Slings were identified and categorized according to the use of mesh by Healthcare Common Procedure Coding System codes and temporary "C" Healthcare Common Procedure Coding System codes. Patients were followed for 1 year after each procedure to identify complications. Logistic models were fit to assess relationships among sling type, surgical setting, and various complications.ResultsWe identified 6,698 Medicare beneficiaries who underwent mesh sling procedures and 445 Medicare beneficiaries who underwent nonmesh sling procedures. The overall frequency of complications was similar between the two groups at 69.8% and 72.6% in the mesh and nonmesh groups, respectively (P=.22). Infectious complications were the most common complication at 45.4% and 50.1% of the mesh and nonmesh groups, respectively (P=.06). Patients undergoing mesh procedures were less likely than patients undergoing nonmesh procedures to require management for bladder outlet obstruction (13.9% compared with 19.3%, adjusted odds ratio [OR] 0.66, 95% confidence interval [CI] 0.52-0.85) and were less likely to have a subsequent sling removal and revision or urethrolysis (2.7% compared with 4.7%, adjusted OR 0.56, 95% CI 0.35-0.89).ConclusionFrequencies of most complications were similar regardless of the use of mesh except for the management of bladder outlet obstruction. These results did not differ based on the surgical setting where the sling procedure was performed.Level of evidenceII.

ContextSexual function is the health-related quality of life (HRQOL) domain most commonly impaired after prostate cancer treatment; however, validated tools to enable personalized prediction of erectile dysfunction after prostate cancer treatment are lacking.ObjectiveTo predict long-term erectile function following prostate cancer treatment based on individual patient and treatment characteristics.DesignPretreatment patient characteristics, sexual HRQOL, and treatment details measured in a longitudinal academic multicenter cohort (Prostate Cancer Outcomes and Satisfaction With Treatment Quality Assessment; enrolled from 2003 through 2006), were used to develop models predicting erectile function 2 years after treatment. A community-based cohort (community-based Cancer of the Prostate Strategic Urologic Research Endeavor [CaPSURE]; enrolled 1995 through 2007) externally validated model performance. Patients in US academic and community-based practices whose HRQOL was measured pretreatment (N = 1201) underwent follow-up after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer. Sexual outcomes among men completing 2 years' follow-up (n = 1027) were used to develop models predicting erectile function that were externally validated among 1913 patients in a community-based cohort.Main outcome measuresPatient-reported functional erections suitable for intercourse 2 years following prostate cancer treatment.ResultsTwo years after prostate cancer treatment, 368 (37% [95% CI, 34%-40%]) of all patients and 335 (48% [95% CI, 45%-52%]) of those with functional erections prior to treatment reported functional erections; 531 (53% [95% CI, 50%-56%]) of patients without penile prostheses reported use of medications or other devices for erectile dysfunction. Pretreatment sexual HRQOL score, age, serum prostate-specific antigen level, race/ethnicity, body mass index, and intended treatment details were associated with functional erections 2 years after treatment. Multivariable logistic regression models predicting erectile function estimated 2-year function probabilities from as low as 10% or less to as high as 70% or greater depending on the individual's pretreatment patient characteristics and treatment details. The models performed well in predicting erections in external validation among CaPSURE cohort patients (areas under the receiver operating characteristic curve, 0.77 [95% CI, 0.74-0.80] for prostatectomy; 0.87 [95% CI, 0.80-0.94] for external radiotherapy; and 0.90 [95% CI, 0.85-0.95] for brachytherapy).ConclusionStratification by pretreatment patient characteristics and treatment details enables prediction of erectile function 2 years after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer.

OBJECTIVE: To understand the effects of accountable care organizations (ACOs) on use of surgery in patients with Alzheimer disease and related dementias (ADRD). STUDY DESIGN: Retrospective national cohort study of all Medicare beneficiaries identified in a 20% sample between 2010 and 2017. The primary exposure was participation in ACOs. The primary outcome was use of 1 of 6 common surgical procedures (aortic valve replacement [AVR], abdominal aortic aneurysm [AAA] repair, colectomy, carotid artery repair, major joint repair, and prostatectomy). METHODS: Multivariable logistic regression models were fit using beneficiary-year as the unit of analysis to estimate the likelihood of undergoing each procedure among patients with ADRD and without ADRD, stratified by ACO participation. Additional models were fit to determine how the relationship between ACO participation and surgery was altered based on procedure urgency and the availability of minimally invasive technology. RESULTS: Adjusted odds for use of surgery were lower among patients with ADRD compared with patients without ADRD for all procedures. ACO participation had varying impact on patients with ADRD, with higher odds of AVR and major joint surgery and lower odds of carotid artery repair. Availability of minimally invasive technology increased the likelihood of AVR and AAA repair among patients with ADRD; however, ACO participation reduced these effects. The effect of ACO participation on the likelihood of undergoing surgery did not vary by urgency of the procedure. CONCLUSIONS: The likelihood of undergoing surgery is overall lower among patients with ADRD and may vary by ACO participation for specific procedures. [ABSTRACT FROM AUTHOR]