Patient-reported Outcomes After External Beam Radiotherapy With Low Dose Rate Brachytherapy Boost vs Radical Prostatectomy for Localized Prostate Cancer: Five-year Results From a Prospective Comparative Effectiveness Study.

PURPOSE: Data comparing radical prostatectomy and external beam radiation therapy with low dose rate brachytherapy boost are lacking. To better guide shared decision making regarding treatment, we compared patient reported outcomes through 5 years following radical prostatectomy or external beam radiation therapy with low dose rate brachytherapy boost for localized prostate cancer. MATERIALS AND METHODS: From 2011-2012, men aged <80 years with localized prostate adenocarcinoma were enrolled and followed longitudinally. Patient reported outcomes included the Expanded Prostate Index Composite. Regression models adjusted for baseline scores and covariates were constructed. RESULTS: The study population included 112 men treated with external beam radiation therapy with low dose rate brachytherapy boost and 1,553 treated with radical prostatectomy. Compared to radical prostatectomy, external beam radiation therapy with low dose rate brachytherapy boost was associated with clinically meaningful worse urinary irritative/obstructive (adjusted mean score difference [95% confidence interval]: 5.0 [-8.7, -1.3]; P = .008 at 5 years) and better urinary incontinence function (13.3 [7.7, 18.9]; P < .001 at 5 years) through 5 years. Urinary function bother was similar between groups (P > .4 at all timepoints). Treatment with external beam radiation therapy with low dose rate brachytherapy boost was associated with worse bowel function (-4.0 [-6.9, -1.1]; P = .006 at 5 years) through 5 years compared to radical prostatectomy. Treatment with external beam radiation therapy with low dose rate brachytherapy boost was associated with better sexual function at 1 year (12.0 [6.5, 17.5]; P < .001 at 1 year) compared to radical prostatectomy, but there was insufficient evidence to reject the supposition that no difference was seen at 3 or 5 years. CONCLUSIONS: Compared to radical prostatectomy, external beam radiation therapy with low dose rate brachytherapy boost was associated with clinically meaningful worse urinary irritative/obstructive and bowel functions but better urinary incontinence function through 5 years after treatment. These patient-reported functional outcomes may clarify treatment expectations and help inform treatment choices for localized prostate cancer.

Association between Treatment for Localized Prostate Cancer and Mental Health Outcomes.

PURPOSE: We aimed to compare patient-reported mental health outcomes for men undergoing treatment for localized prostate cancer longitudinally over 5 years. MATERIALS AND METHODS: We conducted a prospective population-based analysis using the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study. Patient-reported depressive symptoms (Centers for Epidemiologic Studies Depression [CES-D]) and domains of the Medical Outcomes Study 36-item Short Form survey evaluating emotional well-being and energy/fatigue were assessed through 5 years after treatment with surgery, radiotherapy (with or without androgen deprivation therapy) and active surveillance. Regression models were adjusted for outcome-specific baseline function, demographic and clinicopathological characteristics, and treatment approach. RESULTS: A total of 2,742 men (median [quartiles] age 64 [59-70]) met inclusion criteria. Baseline depressive symptoms, as measured by the CES-D, were low (median 4, quartiles 1-8) without differences between groups. We found no effect of treatment modality on depressive symptoms (p=0.78), though older age, poorer health, being unmarried and baseline CES-D score were associated with declines in mental health. There was no clinically meaningful association between treatment modality and scores for either emotional well-being (p=0.81) or energy/fatigue (p=0.054). CONCLUSIONS: This prospective, population-based cohort study of men with localized prostate cancer showed no clinically important differences in mental health outcomes including depressive symptoms, emotional well-being, and energy/fatigue according to the treatment received (surgery, radiotherapy, or surveillance). However, we identified a number of characteristics associated with worse mental health outcomes including: older age, poorer health, being unmarried, and baseline CES-D score which may allow for early identification of patients most at risk of these outcomes following treatment.

The role of parental health and distress in assessing children's health status.

PURPOSE: The purpose of the study was to examine the contributions of parents' health and distress to parent's and children's assessments of children's health. METHODS: We used baseline data from a longitudinal study of 364 children (ages 4-12) about to undergo surgery and their parents in a Southern California pediatric hospital. We used the 20-item child self-reported CHRIS 2.0 general health and the parallel parent-reported measure of the child's health, along with a measure of parental distress about the child's health were administered in the perioperative period. Other measures included parents' physical and mental health, quality of life, distress over their child's health, and number and extent of other health problems of the child and siblings. RESULTS: On average, parents' reports about the child were consistently and statistically significantly higher than children's self-reports across all sub-dimensions of the CHRIS 2.0 measure. Parents' personal health was positively associated with their reports of the child's health. More distressed parents were closer to the child's self-reports, but reported poorer personal health. CONCLUSION: Parent-child differences in this study of young children's health were related to parental distress. Exploring the nature of the gap between parents and children in assessments of children's health could improve effective clinical management for the child and enhance family-centered pediatric care. Future studies are needed to assess the generalizability of CHRIS 2.0 to other health settings and conditions and to other racial/ethnic groups.

Five-year outcomes from a prospective comparative effectiveness study evaluating external-beam radiotherapy with or without low-dose-rate brachytherapy boost for localized prostate cancer.

BACKGROUND: To inform patients who are in the process of selecting prostate cancer treatment, the authors compared disease-specific function after external-beam radiotherapy (EBRT) alone versus EBRT plus a low-dose-rate (LDR) brachytherapy boost (EBRT-LDR). METHODS: For this prospective study, men who had localized prostate cancer in 2011 and 2012 were enrolled. Assessments at baseline, 0.5, 1, 3, and 5 years included the patient-reported Expanded Prostate Index Composite, the 36-item Medical Outcomes Study Short-Form Health Survey, and treatment-related regret. Regression models were adjusted for baseline function and for patient and treatment characteristics. The minimum clinically important difference in scores on the Expanded Prostate Index Composite 26-item instrument was from 5 to 7 for urinary irritation and from 4 to 6 for bowel function. RESULTS: Six-hundred ninety-five men met inclusion criteria and received either EBRT (n = 583) or EBRT-LDR (n = 112). Patients in the EBRT-LDR group were younger (median age, 66 years [interquartile range [IQR], 60-71 years] vs 69 years [IQR, 64-74 years]; P < .001), were less likely to receive pelvic radiotherapy (10% vs 18%; P = .040), and had higher baseline 36-item Medical Outcomes Study Short-Form Health Survey physical function scores (median score, 95 [IQR, 86-100] vs 90 [IQR, 70-100]; P < .001). Over a 3-year period, compared with EBRT, EBRT-LDR was associated with worse urinary irritative scores (adjusted mean difference at 3 years, -5.4; 95% CI, -9.3, -1.6) and bowel function scores (-4.1; 95% CI, -7.6, -0.5). The differences were no longer clinically meaningful at 5 years (difference in urinary irritative scores: -4.5; 95% CI, -8.4, -0.5; difference in bowel function scores: -2.1; 95% CI, -5.7, -1.4). However, men who received EBRT-LDR were more likely to report moderate or big problems with urinary function bother (adjusted odds ratio, 3.5; 95% CI, 1.5-8.2) and frequent urination (adjusted odds ratio, 2.6; 95% CI, 1.2-5.6) through 5 years. There were no differences in survival or treatment-related regret between treatment groups. CONCLUSIONS: Compared with EBRT alone, EBRT-LDR was associated with clinically meaningful worse urinary irritative and bowel function over 3 years after treatment and more urinary bother at 5 years. LAY SUMMARY: In men with prostate cancer who received external-beam radiation therapy (EBRT) with or without a brachytherapy boost (EBRT-LDR), EBRT-LDR was associated with clinically worse urinary irritation and bowel function through 3 years but resolved after 5 years. Men who received EBRT-LDR continued to report moderate-to-big problems with urinary function bother and frequent urination through 5 years. There was no difference in treatment-related regret or survival between patients who received EBRT and those who received EBRT-LDR. These intermediate-term estimates of function may facilitate counseling for men who are selecting treatment.

Patient-Reported Financial Toxicity Associated with Contemporary Treatment for Localized Prostate Cancer.

PURPOSE: Contemporary treatment modalities for localized prostate cancer provide comparable overall and cancer-specific survival. However, the degree of financial burden imposed by treatment, the factors contributing to that burden, and how different treatments compare with regard to financial toxicity remain poorly understood. MATERIALS AND METHODS: The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study enrolled men with localized prostate cancer from 2011 to 2012. Questionnaires were collected at 6, 12, 36, and 60 months after enrollment. Differences in patient-reported financial burden were compared between active surveillance, radical prostatectomy, and external beam radiotherapy using multivariable logistic regression. RESULTS: Among 2,121 patients meeting inclusion criteria, 15% reported large or very large burden of treatment costs within 6 months, declining to 3% by year 5. When controlling for age, education, income and other covariates, external beam radiotherapy was associated with greater financial burden than active surveillance and radical prostatectomy at 1 year (OR 2.2, 95% CI 1.2-4.1 and OR 1.5, 95% CI 1.0-2.3, respectively) and 3 years (OR 3.1 95% CI 1.1-8.8 and OR 2.1, 95% CI 1.2-3.7, respectively). Radical prostatectomy and active surveillance had similar rates of financial burden at all time points. Age, race, education, and D'Amico risk group were associated with financial burden. CONCLUSIONS: External beam radiotherapy was associated with the highest financial burden, even when controlling for age, education and income. Prospective studies that directly measure out-of-pocket and indirect costs and account more thoroughly for baseline socioeconomic differences are warranted in order to identify those most at risk.

Development and initial validation of self-report measures of general health, preoperative anxiety, and postoperative pain in young children using computer-administered animation.

BACKGROUND: For young children, existing measures of children's health-related quality of life must be parent-reported or interviewer-administered for those who cannot read or complete measures independently. Parents' and childrens' reports about the child's health have been shown to disagree. AIMS: (a) To test the reliability and validity of an animated, computer-administered Child Health Rating Inventories (CHRIS2.0) among children aged 4-12 undergoing surgery; and (b) to develop and test two CHRIS measures of preoperative anxiety and postoperative pain management. METHODS: We conducted a longitudinal cohort study of a diverse group of 542 children aged 4-12 undergoing surgery. We compared the CHRIS measures to Pediatric Quality of Life Inventory (PedsQL), the Functional Disabilities Inventory (FDI), State-Trait Anxiety Inventory for children (STAI-CH), and the Parent Postoperative Pain Measure (PPPM). RESULTS: Factor analyses supported the construct validity of the 12-item general physical health and the 8-item mental health CHRIS scales, as well as a composite 20-item scale, and the CHRIS preoperative anxiety and postoperative pain scales. Internal consistency reliability for all CHRIS scales exceeded the standard for group comparisons (Cronbach's α ≥0.70). The CHRIS general health composite was significantly correlated with composite PedsQL and FDI (r = 0.28, P < .001 and r = 0.43, P < .001, respectively). The CHRIS peri-operative anxiety measure was significantly correlated with the STAI-CH (r = 0.44, P < .001), as was the CHRIS postoperative pain scale with the PPPM (r = 0.52, P < .001). CONCLUSIONS: The CHRIS measures were reliable and valid in this diverse sample of young children (4-12). Because CHRIS measures are self-administered, scored in real time, and run on multiple different platforms, this approach provides a feasible method for the collection of health-related quality of life in young children and those with limited literacy. Our data indicate that this approach is psychometrically sound and has the potential for adding the child's voice to pediatric outcomes.

Assessing the Quality of Surgical Care for Clinically Localized Prostate Cancer: Results from the CEASAR Study.

PURPOSE: Prior studies suggest that nationally endorsed quality measures for prostate cancer care are not linked closely with outcomes. Using a prospective, population based cohort we measured clinically relevant variation in structure, process and outcome measures in men undergoing radical prostatectomy. MATERIALS AND METHODS: The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) Study enrolled men with clinically localized prostate cancer diagnosed from 2011 to 2012 with 1,069 meeting the final inclusion criteria. Quality of life was assessed using the Expanded Prostate Index Composite (EPIC-26) and clinical data by chart review. Six quality measures were assessed, including pelvic lymphadenectomy with risk of lymph node involvement 2% or greater, appropriate nerve sparing, negative surgical margins, urinary and sexual function, treatment by high volume surgeon, and 30-day and 1-year complications. Receipt of high quality care was compared across categories of race, age, surgeon volume and surgical approach via multivariable analysis. RESULTS: There were no significant differences in quality across race, age or surgeon volume strata, except for worse urinary incontinence in Black men. However, robotic surgery patients experienced fewer complications (3% vs 9.3% short-term and 11% vs 16% long-term), were more likely to be treated by a high volume surgeon (47% vs 25%) and demonstrated better sexual function. CONCLUSIONS: In this cohort we did not identify meaningful variation in quality of care across racial groups, age groups and surgeon volume strata, suggesting that men are receiving comparable quality of care across these strata. However, we did find variation between open and robotic surgery with fewer complications, improved sexual function and increased use of high volume surgeons in the robotic group, possibly reflecting differences in quality between approaches, differences in practice patterns and/or biases in patient selection.

Patient-Reported Outcomes Through 5 Years for Active Surveillance, Surgery, Brachytherapy, or External Beam Radiation With or Without Androgen Deprivation Therapy for Localized Prostate Cancer.

Importance: Understanding adverse effects of contemporary treatment approaches for men with favorable-risk and unfavorable-risk localized prostate cancer could inform treatment selection. Objective: To compare functional outcomes associated with prostate cancer treatments over 5 years after treatment. Design, Setting, and Participants: Prospective, population-based cohort study of 1386 men with favorable-risk (clinical stage cT1 to cT2bN0M0, prostate-specific antigen [PSA] ≤20 ng/mL, and Grade Group 1-2) prostate cancer and 619 men with unfavorable-risk (clinical stage cT2cN0M0, PSA of 20-50 ng/mL, or Grade Group 3-5) prostate cancer diagnosed in 2011 through 2012, accrued from 5 Surveillance, Epidemiology and End Results Program sites and a US prostate cancer registry, with surveys through September 2017. Exposures: Treatment with active surveillance (n = 363), nerve-sparing prostatectomy (n = 675), external beam radiation therapy (EBRT; n = 261), or low-dose-rate brachytherapy (n = 87) for men with favorable-risk disease and treatment with prostatectomy (n = 402) or EBRT with androgen deprivation therapy (n = 217) for men with unfavorable-risk disease. Main Outcomes and Measures: Patient-reported function, based on the 26-item Expanded Prostate Index Composite (range, 0-100), 5 years after treatment. Regression models were adjusted for baseline function and patient and tumor characteristics. Minimum clinically important difference was 10 to 12 for sexual function, 6 to 9 for urinary incontinence, 5 to 7 for urinary irritative symptoms, and 4 to 6 for bowel and hormonal function. Results: A total of 2005 men met inclusion criteria and completed the baseline and at least 1 postbaseline survey (median [interquartile range] age, 64 [59-70] years; 1529 of 1993 participants [77%] were non-Hispanic white). For men with favorable-risk prostate cancer, nerve-sparing prostatectomy was associated with worse urinary incontinence at 5 years (adjusted mean difference, -10.9 [95% CI, -14.2 to -7.6]) and sexual function at 3 years (adjusted mean difference, -15.2 [95% CI, -18.8 to -11.5]) compared with active surveillance. Low-dose-rate brachytherapy was associated with worse urinary irritative (adjusted mean difference, -7.0 [95% CI, -10.1 to -3.9]), sexual (adjusted mean difference, -10.1 [95% CI, -14.6 to -5.7]), and bowel (adjusted mean difference, -5.0 [95% CI, -7.6 to -2.4]) function at 1 year compared with active surveillance. EBRT was associated with urinary, sexual, and bowel function changes not clinically different from active surveillance at any time point through 5 years. For men with unfavorable-risk disease, EBRT with ADT was associated with lower hormonal function at 6 months (adjusted mean difference, -5.3 [95% CI, -8.2 to -2.4]) and bowel function at 1 year (adjusted mean difference, -4.1 [95% CI, -6.3 to -1.9]), but better sexual function at 5 years (adjusted mean difference, 12.5 [95% CI, 6.2-18.7]) and incontinence at each time point through 5 years (adjusted mean difference, 23.2 [95% CI, 17.7-28.7]), than prostatectomy. Conclusions and Relevance: In this cohort of men with localized prostate cancer, most functional differences associated with contemporary management options attenuated by 5 years. However, men undergoing prostatectomy reported clinically meaningful worse incontinence through 5 years compared with all other options, and men undergoing prostatectomy for unfavorable-risk disease reported worse sexual function at 5 years compared with men who underwent EBRT with ADT.

Interpretation of Domain Scores on the EPIC-How Does the Domain Score Translate into Functional Outcomes?

PURPOSE: The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring health related quality of life. However, the relationship between domain scores and functional outcomes remains unclear, leading to potential confusion about expectations after treatment. For instance, does a sexual function domain score of 80 mean that a patient can achieve erection sufficient for intercourse? Consequently we sought to determine the relationship between the domain score and the response to obtaining the best possible outcome for each question. MATERIALS AND METHODS: Using data from the CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study, a multicenter, prospective study of men diagnosed with localized prostate cancer, we analyzed 11,464 EPIC-26 questionnaires from a total of 2,563 men at baseline through 60 months of followup who were treated with robotic prostatectomy, radiotherapy or active surveillance. We dichotomized every item into its best possible outcome and assessed the percent of men at each domain score who achieved the best result. RESULTS: For every EPIC-26 item the frequency of the best possible outcome was reported by domain score category. For example, a score of 80 to 100 on sexual function corresponded to 97% of men reporting erections sufficient for intercourse while at a score of 40 to 60 only 28% reported adequate erections. Also, at a score of 80 to 100 on the urinary incontinence domain 93% of men reported rarely or never leaking vs 6% at a score of 61 to 80. CONCLUSIONS: Our findings indicate a novel way to interpret EPIC-26 domain scores, demonstrating large variations in the percent of respondents reporting the best possible outcomes over narrow domain score differences. This information may be valuable when counseling men on treatment options.

Parental satisfaction of child's perioperative care.

BACKGROUND: Satisfaction in the hospital setting is an important component of both hospital funding and patient experience. When it comes to a child's hospital experience, parent satisfaction of their child's perioperative care is also necessary to understand. However, little research has been conducted on the predictors of this outcome. Therefore, the purpose of this current study was to validate a priori selected predictors for parental satisfaction in their child's perioperative process. METHODS: Eight hundred and ten pediatric patients who underwent tonsillectomy and adenoidectomy surgery and their parents were included in this study. The primary outcome was assessed using a 21-item parent satisfaction questionnaire resulting in three satisfaction scores: overall care satisfaction, OR/induction satisfaction, and total satisfaction. RESULTS: Descriptive statistics and correlational analysis found that sedative-premedication, parental presence at anesthesia induction, child social functioning, parental anxiety, and language were all significant predictors of various components of the satisfaction score. Regression models, however, revealed that only parent anxiety and child social functioning remained significant predictors such that parents who reported lower state anxiety (OR/induction satisfaction: OR = 0.975, 95% CI [0.957, 0.994]; total satisfaction: OR = 0.968, 95% CI [0.943, 0.993]) and who had higher socially functioning children (overall care satisfaction: OR = 1.019, 95% CI [1.005, 1.033]; OR/induction satisfaction: OR = 1.011, 95% CI [1.000, 1.022]) were significantly more satisfied with the perioperative care they received. CONCLUSION: Lower parent anxiety and higher child social functioning were predictive of higher parental satisfaction scores.

Association Between Radiation Therapy, Surgery, or Observation for Localized Prostate Cancer and Patient-Reported Outcomes After 3 Years.

Importance: Understanding the adverse effects of contemporary approaches to localized prostate cancer treatment could inform shared decision making. Objective: To compare functional outcomes and adverse effects associated with radical prostatectomy, external beam radiation therapy (EBRT), and active surveillance. Design, Setting, and Participants: Prospective, population-based, cohort study involving 2550 men (≤80 years) diagnosed in 2011-2012 with clinical stage cT1-2, localized prostate cancer, with prostate-specific antigen levels less than 50 ng/mL, and enrolled within 6 months of diagnosis. Exposures: Treatment with radical prostatectomy, EBRT, or active surveillance was ascertained within 1 year of diagnosis. Main Outcomes and Measures: Patient-reported function on the 26-item Expanded Prostate Cancer Index Composite (EPIC) 36 months after enrollment. Higher domain scores (range, 0-100) indicate better function. Minimum clinically important difference was defined as 10 to 12 points for sexual function, 6 for urinary incontinence, 5 for urinary irritative symptoms, 5 for bowel function, and 4 for hormonal function. Results: The cohort included 2550 men (mean age, 63.8 years; 74% white, 55% had intermediate- or high-risk disease), of whom 1523 (59.7%) underwent radical prostatectomy, 598 (23.5%) EBRT, and 429 (16.8%) active surveillance. Men in the EBRT group were older (mean age, 68.1 years vs 61.5 years, P < .001) and had worse baseline sexual function (mean score, 52.3 vs 65.2, P < .001) than men in the radical prostatectomy group. At 3 years, the adjusted mean sexual domain score for radical prostatectomy decreased more than for EBRT (mean difference, -11.9 points; 95% CI, -15.1 to -8.7). The decline in sexual domain scores between EBRT and active surveillance was not clinically significant (-4.3 points; 95% CI, -9.2 to 0.7). Radical prostatectomy was associated with worse urinary incontinence than EBRT (-18.0 points; 95% CI, -20.5 to -15.4) and active surveillance (-12.7 points; 95% CI, -16.0 to -9.3) but was associated with better urinary irritative symptoms than active surveillance (5.2 points; 95% CI, 3.2 to 7.2). No clinically significant differences for bowel or hormone function were noted beyond 12 months. No differences in health-related quality of life or disease-specific survival (3 deaths) were noted (99.7%-100%). Conclusions and Relevance: In this cohort of men with localized prostate cancer, radical prostatectomy was associated with a greater decrease in sexual function and urinary incontinence than either EBRT or active surveillance after 3 years and was associated with fewer urinary irritative symptoms than active surveillance; however, no meaningful differences existed in either bowel or hormonal function beyond 12 months or in in other domains of health-related quality-of-life measures. These findings may facilitate counseling regarding the comparative harms of contemporary treatments for prostate cancer.

The Comparative Harms of Open and Robotic Prostatectomy in Population Based Samples.

PURPOSE: Robotic assisted radical prostatectomy has largely replaced open radical prostatectomy for the surgical management of prostate cancer despite conflicting evidence of superiority with respect to disease control or functional sequelae. Using population cohort data, in this study we examined sexual and urinary function in men undergoing open radical prostatectomy vs those undergoing robotic assisted radical prostatectomy. MATERIALS AND METHODS: Subjects surgically treated for prostate cancer were selected from 2 large population based prospective cohort studies, the Prostate Cancer Outcomes Study (enrolled 1994 to 1995) and the Comparative Effectiveness Analysis of Surgery and Radiation (enrolled 2011 to 2012). Subjects completed baseline, 6-month and 12-month standardized patient reported outcome measures. Main outcomes were between-group differences in functional outcome scores at 6 and 12 months using linear regression, and adjusting for baseline function, sociodemographic and clinical characteristics. Sensitivity analyses were used to evaluate outcomes between patients undergoing open radical prostatectomy and robotic assisted radical prostatectomy within and across CEASAR and PCOS. RESULTS: The combined cohort consisted of 2,438 men, 1,505 of whom underwent open radical prostatectomy and 933 of whom underwent robotic assisted radical prostatectomy. Men treated with robotic assisted radical prostatectomy reported better urinary function at 6 months (mean difference 3.77 points, 95% CI 1.09-6.44) but not at 12 months (1.19, -1.32-3.71). Subjects treated with robotic assisted radical prostatectomy also reported superior sexual function at 6 months (8.31, 6.02-10.56) and at 12 months (7.64, 5.25-10.03). Sensitivity analyses largely supported the sexual function findings with inconsistent support for urinary function results. CONCLUSIONS: This population based study reveals that men undergoing robotic assisted radical prostatectomy likely experience less decline in early urinary continence and sexual function than those undergoing open radical prostatectomy. The clinical meaning of these differences is uncertain and longer followup will be required to establish whether these benefits are durable.

Impact of Adherence to Quality Measures for Localized Prostate Cancer on Patient-reported Health-related Quality of Life Outcomes, Patient Satisfaction, and Treatment-related Complications.

BACKGROUND AND OBJECTIVE: Quality measures used in pay-for-performance systems are intended to address specific quality goals, such as safety, efficiency, effectiveness, timeliness, equity, and patient-centeredness. Given the small number of narrowly focused measures in prostate cancer care, we sought to determine whether adherence to any of the available payer-driven quality measures influences patient-centered outcomes, including health-related quality of life (HRQOL), patient satisfaction, and treatment-related complications. METHODS: The Comparative Effectiveness Analysis of Surgery and Radiation study is a population-based, prospective cohort study that enrolled 3708 men with clinically localized prostate cancer during 2011 and 2012, of whom 2601 completed the 1-year survey and underwent complete chart abstraction. Compliance with 6 quality indicators endorsed by national consortia was assessed. Multivariable regression was used to determine the relationship between indicator compliance and Expanded Prostate Cancer Index Composite (EPIC-26) instrument summary scores, satisfaction scale scores (service satisfaction scale for cancer care), and treatment-related complications. RESULTS: Overall rates of compliance with these quality measures ranged between 64% and 88%. Three of the 6 measures were weakly associated with 1-year sexual function and bowel function scores (ß=-4.6, 1.69, and 2.93, respectively; P≤0.05), whereas the remaining measures had no significant relationship with patient-reported HRQOL outcomes. Satisfaction scores and treatment-related complications were not associated with quality measure compliance. CONCLUSIONS: Compliance with available nationally endorsed quality indicators, which were designed to incentivize effective and efficient care, was not associated with clinically important changes in patient-centered outcomes (HRQOL, satisfaction, or complications) within 1-year.

Predicting the Risk of Breakthrough Urinary Tract Infections: Primary Vesicoureteral Reflux.

PURPOSE: We constructed a risk prediction instrument stratifying patients with primary vesicoureteral reflux into groups according to their 2-year probability of breakthrough urinary tract infection. MATERIALS AND METHODS: Demographic and clinical information was retrospectively collected in children diagnosed with primary vesicoureteral reflux and followed for 2 years. Bivariate and binary logistic regression analyses were performed to identify factors associated with breakthrough urinary tract infection. The final regression model was used to compute an estimation of the 2-year probability of breakthrough urinary tract infection for each subject. Accuracy of the binary classifier for breakthrough urinary tract infection was evaluated using receiver operator curve analysis. Three distinct risk groups were identified. The model was then validated in a prospective cohort. RESULTS: A total of 252 bivariate analyses showed that high grade (IV or V) vesicoureteral reflux (OR 9.4, 95% CI 3.8-23.5, p <0.001), presentation after urinary tract infection (OR 5.3, 95% CI 1.1-24.7, p = 0.034) and female gender (OR 2.6, 95% CI 0.097-7.11, p <0.054) were important risk factors for breakthrough urinary tract infection. Subgroup analysis revealed bladder and bowel dysfunction was a significant risk factor more pronounced in low grade (I to III) vesicoureteral reflux (OR 2.8, p = 0.018). The estimation model was applied for prospective validation, which demonstrated predicted vs actual 2-year breakthrough urinary tract infection rates of 19% vs 21%. Stratifying the patients into 3 risk groups based on parameters in the risk model showed 2-year risk for breakthrough urinary tract infection was 8.6%, 26.0% and 62.5% in the low, intermediate and high risk groups, respectively. CONCLUSIONS: This proposed risk stratification and probability model allows prediction of 2-year risk of patient breakthrough urinary tract infection to better inform parents of possible outcomes and treatment strategies.

Mental health symptoms and patient-reported diabetes symptom burden: implications for medication regimen changes.

AIMS: To examine the relative contribution of glycaemic control (HbA1C) and depressive symptoms on diabetes-related symptom burden (hypoglycaemia and hyperglycaemia) in order to guide medication modification. METHODS: Secondary analysis of medical records data and questionnaires collected from a racially/ethnically diverse sample of adult patients with type 2 diabetes (n = 710) from seven outpatient clinics affiliated with an academic medical centre over a 1-year period as part of the Reducing Racial Disparities in Diabetes: Coached Care (R2D2C2) study. RESULTS: Results from linear regression analysis revealed that patients with high levels of depressive symptoms had more diabetes-related symptom burden (both hypoglycaemia and hyperglycaemia) than patients with low levels of depressive symptoms (ßs = 0.09-0.17, Ps < 0.02). Furthermore, results from two logistic regression analyses suggested that the odds of regimen intensification at 1-year follow-up was marginally associated with patient-reported symptoms of hypoglycaemia [adjusted odds ratio (aOR) = 1.24, 95% CI: 0.98-1.58; P = 0.08] and hyperglycaemia (aOR = 1.21, 95% CI: 1.00-1.46; P = 0.05), after controlling for patients' HbA1C, comorbidity, insulin use and demographics. These associations, however, were diminished for patients with high self-reported hypoglycaemia and high levels of depressive symptoms, but not low depressive symptoms (interaction terms for hypoglycaemia by depressive symptoms, aOR = 0.98, 95% CI: 0.97-0.99; P = 0.03). CONCLUSIONS: Mental health symptoms are associated with higher levels of patient-reported of diabetes-related symptoms, but the association between diabetes-related symptoms and subsequent regimen modifications is diminished in patients with greater depressive symptoms. Clinicians should focus attention on identifying and treating patients' mental health concerns in order to address the role of diabetes-related symptom burden in guiding physician medication prescribing behaviour.

Revisiting a measure of child postoperative recovery: development of the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery.

BACKGROUND: The Post Hospitalization Behavior Questionnaire (PHBQ) was designed for assessing children's posthospitalization and postoperative new-onset behavioral changes. However, the psychometric properties of the scale have not been re-evaluated in the past five decades despite substantial changes in the practice of surgery and anesthesia. In this investigation, we examined the psychometric properties of the PHBQ to potentially increase the efficacy and relevance of the instrument in current perioperative settings. METHOD: This study used principal components analysis, a panel of experts, Cronbach's alpha, and correlations to examine the current subscale structure of the PHBQ and eliminate items to create the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). Data from previous investigations (N = 1064, Mage  = 5.88) which utilized the PHBQ were combined for the purposes of this paper. RESULTS: A principal components analysis revealed that the original subscale structure of the PHBQ could not be replicated. Subsequently, a battery reduction, which utilized principal components analysis and a panel of experts, was used to eliminate the subscale structure of the scale and reduce the number of items from 27 to 11, creating the PHBQ-AS. The PHBQ-AS demonstrated good internal consistency reliability and concurrent validity with another measure of children's psychosocial and physical functioning. CONCLUSION: Revising the former subscale structure and reducing the number of items in the PHBQ to create the PHBQ-AS may provide a means for reducing the burden of postoperative behavioral assessment through decreasing time of administration and eliminating redundancy of items and allow for more accurate measurement of child postoperative behavioral changes.

Development of a short version of the modified Yale Preoperative Anxiety Scale.

BACKGROUND: The modified Yale Preoperative Anxiety Scale (mYPAS) is the current "criterion standard" for assessing child anxiety during induction of anesthesia and has been used in >100 studies. This observational instrument covers 5 items and is typically administered at 4 perioperative time points. Application of this complex instrument in busy operating room (OR) settings, however, presents a challenge. In this investigation, we examined whether the instrument could be modified and made easier to use in OR settings. METHODS: This study used qualitative methods, principal component analyses, Cronbach αs, and effect sizes to create the mYPAS-Short Form (mYPAS-SF) and reduce time points of assessment. Data were obtained from multiple patients (N = 3798; Mage = 5.63) who were recruited in previous investigations using the mYPAS over the past 15 years. RESULTS: After qualitative analysis, the "use of parent" item was eliminated due to content overlap with other items. The reduced item set accounted for 82% or more of the variance in child anxiety and produced the Cronbach α of at least 0.92. To reduce the number of time points of assessment, a minimum Cohen d effect size criterion of 0.48 change in mYPAS score across time points was used. This led to eliminating the walk to the OR and entrance to the OR time points. CONCLUSIONS: Reducing the mYPAS to 4 items, creating the mYPAS-SF that can be administered at 2 time points, retained the accuracy of the measure while allowing the instrument to be more easily used in clinical research settings.

Consideration of comorbidity in risk stratification prior to prostate biopsy.

BACKGROUND: Previously, the patient-reported Total Illness Burden Index for Prostate Cancer (TIBI-CaP) questionnaire and/or the physician-reported Charlson Comorbidity Index (CCI) have provided assessments of competing comorbidity during treatment decisions for patients with prostate cancer. In the current study, the authors used these assessments to determine comorbidity and prognosis before prostate biopsy and the subsequent diagnosis of prostate cancer to identify those patients least likely to benefit from treatment. METHODS: A prospective observational cohort study was performed of 104 participants aged 64.0 years ± 6.5 years from 3 institutions representing different health care delivery systems. Patients were identified before undergoing transrectal ultrasound-guided prostate biopsy and followed for a median of 28 months. Associations between the comorbidity scores and nonelective hospital admissions were investigated using logistic regression and Cox proportional hazards models. RESULTS: Among the 104 patients who underwent prostate biopsy, 2 died during the follow-up period. The overall hospital admission rate was 20% (21 of 104 patients). Higher scores on both the TIBI-CaP (≥ 9) and CCI (≥ 3) were found to be significantly associated with an increased odds for hospital admission (odds ratio, 11.3 [95% confidence interval (95% CI), 2.4-53.6] and OR, 5.7 [95% CI, 1.4-22.4]) and hazards ratios (HRs) for time to hospital admission (HR, 3.8 [95% CI, 1.3-11.2] and HR, 3.2 [95% CI, 1.1-9.1]), respectively. CONCLUSIONS: TIBI-CaP and CCI scores were found to successfully predict which patients were at high risk for nonelective hospital admission. These patients are likely to have poorer health and a potentially shortened lifespan. Therefore, comorbidity analysis using these tools may help to identify those patients who are least likely to benefit from prostate cancer therapy and should avoid prostate biopsy.

Patient complexity and risk factor control among multimorbid patients with type 2 diabetes: results from the R2D2C2 study.

BACKGROUND: Among patients with type 2 diabetes, it is not known whether risk factor control is better or worse for those who also have heart disease, depression, multiple other comorbidities, and associated management challenges. OBJECTIVE: To examine the relationship between this complex constellation of multimorbidities, adherence to treatment and risk factor control among patients with type 2 diabetes, independent of regimen intensity. RESEARCH DESIGN: Observational cross-sectional study. SUBJECTS: A total of 1314 patients with diabetes from the Reducing Racial Disparities in Diabetes Coached Care (R2D2C2) Study. MEASURES: A composite cardiometabolic risk factor profile was the dependent variable. Independent variables included a composite measure of patient complexity, patient-reported adherence to treatment, history of coronary heart disease (CHD), and intensity of medication regimen. RESULTS: A higher proportion of the most complex patient-reported problems with adherence compared with the least complex patients (83.5% vs. 43.3%, P<0.001). Compared with those without a history of CHD, fewer patients with CHD-reported problems with medication adherence (59.3% vs. 69.3%, P<0.01) and had better risk factor control, independent of complexity and regimen intensity. Better risk factor control was independently associated with less patient complexity (P=0.003) and to history of CHD (P=0.01). CONCLUSIONS: The presence of a complex illness profile was associated with poorer control of risk factors. Those with CHD were more adherent to treatment and had better risk factor control. The occurrence of CHD may present an opportunity for physicians to emphasize risk factor management. Diabetes patients with a complex illness profile may be at highest risk for cardiovascular events and in greatest need of prevention of cardiac disease. TRIAL REGISTRATION: Clinicaltrial.gov identifier: NCT01123239.