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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.From 2011-2012, men aged80 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.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];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.

Purpose Medical schools must have clear policies and procedures for promotion and tenure (P&T) of faculty. Social media and digital scholarship (SMDS) is an emerging form of scholarship capable of reaching audiences quickly, conveniently, and in a wide variety of formats. It is unclear how frequently SMDS is considered during P&T reviews. The authors sought to determine whether current P&T guidelines at medical schools consider SMDS. Method The authors acquired P&T guidelines from any U.S. Liaison Committee on Medical Education-accredited medical school (or their governing university) that were available online between October and December 2020. Using an iterative process, they developed a bank of keywords that were specific to SMDS or that could include SMDS between October and December 2020. The authors searched each school's guidelines for each keyword and determined whether the word was being used in relation to crediting faculty for SMDS in the context of P&T procedures. The primary outcome measure was the dichotomous presence or absence of SMDS-specific keywords in each school's P&T guidelines. Results The authors acquired P&T guidelines from 145/154 (94%) medical schools. After removing duplicate documents, the authors considered 139 guidelines. The keyword bank included 59 terms, of which 49 were specific to SMDS and 10 were umbrella terms that could be inclusive of SMDS. Of the 139 guidelines, 121 (87%) contained at least one SMDS-specific keyword. Schools had a median of 3 SMDS-specific keywords in their P&T guidelines. Conclusions As the presence and impact of SMDS increases, schools should provide guidance on its role in the P&T process. Faculty should receive clear guidance on how to document quality SMDS for their promotion file.

Background Nursing homes (NHs) are high risk settings for COVID. Staff are the primary source for introducing COVID into a NH. Preventing staff from working when ill is key to resident safety. NH staff face significant socioeconomic pressures that may influence their willingness to report COVID symptoms. Understanding the drivers behind unreported illness can inform ways to prevent working when ill. Methods We conducted a confidential survey of 120 COVID-positive NH staff in Orange County, CA from Dec ‘20-Feb ‘22 to quantify the frequency and drivers of unreported COVID symptoms. We designed a 40-item survey to assess demographics, course of illness, symptom reporting behavior, and monetary, logistic, and emotional (stigma/fear) barriers to reporting using a 5-point Likert scale. Recruitment flyers were shared with all 70 NHs in the county and referrals were accepted from NH leadership. Participants received $50 for completing the 20-30 min phone-based survey. We calculated summary statistics, transformed all data to a 0-100 scale, assessed the reliability of each factor related to reporting at the group level using Cronbach’s alpha, and assessed discriminant validity with t-tests comparing responses among subsets expected to differ. Results Table 1 shows participant characteristics. 49% of surveys were during the 2020-21 winter wave and 51% were during the Delta/Omicron waves, with a relatively even distribution of certified nursing assistants (CNAs), nurses, and non-frontline staff. Most cases (70%) were detected by routine testing at the NH and most (63%) had ≥1 symptom prior to their test. Only 39% disclosed their symptom to a supervisor. It is unknown how many staff would have disclosed symptoms if they were not captured during routine testing. Responses were consistent across 15 discrete factors with Cronbach alpha >0.7. Overall, fear and encouragement from supervisors were the most salient factors for speaking up about COVID symptoms (Table 2). Responses varied between the two waves and between frontline vs non-frontline workers. Conclusion Frequent surveillance testing of NH staff during a pandemic is critical due to many factors that drive reluctance to speak up about potential symptoms. Encouragement from supervisors to report symptoms and stay home when ill may improve NH safety. Disclosures Gabrielle M. Gussin, MS, Medline: Conducted studies in which hospitals and nursing homes received contributed antiseptic and/or environmental cleaning products|Stryker: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic products|Xttrium Laboratories: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic products Raveena D. Singh, MA, Medline: Conducted studies in which hospitals and nursing homes received contributed antiseptic and/or environmental cleaning products|Stryker: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic products|Xttrium Laboratories: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic products Raheeb Saavedra, AS, Medline: Conducted studies in which hospitals and nursing homes received contributed antiseptic and/or environmental cleaning products|Stryker: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic products|Xttrium Laboratories: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic products Susan S. Huang, MD, MPH, Medline: Conducted studies in which hospitals and nursing homes received contributed antiseptic and/or environmental cleaning products|Molnlyke: Conducted clinical studies in which hospitals received contributed antiseptic product|Stryker: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic products|Xttrium Laboratories: Conducted clinical studies in which hospitals and nursing homes received contributed antiseptic product.

Sexual dysfunction, including erectile dysfunction and loss of libido, are common among men undergoing treatment for localized prostate cancer. Both local treatments and systemic androgen deprivation therapy may contribute to these outcomes and are differentially indicated based on disease characteristics. We sought to compare sexual function through 5 years after radiation treatment with and without androgen deprivation therapy in men with good baseline sexual function to better understand long-term effects in this understudied subset of patients. We retrospectively reviewed a prospectively assembled population-based cohort of men who underwent radiation with and without androgen deprivation therapy for intermediate or high-risk localized prostate cancer. Sexual function was assessed longitudinally over 5 years. Men with erections sufficient for intercourse at baseline were selected for inclusion. Out of 167 patients included, 73 underwent radiation alone and 94 received androgen deprivation therapy plus radiation (51 with intermediate and 43 with high-risk disease). Androgen deprivation therapy use was associated with worse sexual function through 1 year regardless of disease risk. This difference was no longer statistically significant at 3 years in the intermediate-risk group. Compared to radiation alone, androgen deprivation therapy in high-risk disease was associated with worse sexual function at 3 years (effect: −20.3 points, CI [−31.8, −8.8], p

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.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.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.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.

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

Background Financial toxicity is emerging as an important patient-centered outcome and is understudied in prostate cancer patients. We sought to understand the association between financial burden and treatment regret in men with localized prostate cancer to better evaluate the role of financial discussions in patient counseling. Methods Utilizing the Comparative Effectiveness Analysis of Surgery and Radiation dataset, we identified all men accrued between 2011 and 2012 who underwent surgery, radiation, or active surveillance for localized prostate cancer. Financial burden and treatment regret were assessed at 3- and 5-year follow-up. The association between financial burden and regret was assessed using multivariable longitudinal logistic regression controlling for demographic and disease characteristics, treatment, functional outcomes, and patient expectations. Results Of the 2924 eligible patients, regret and financial burden assessments for 3- and/or 5-year follow-up were available for 81% (n = 2359). After adjustment for relevant covariates, financial burden from “finances in general” was associated with treatment regret at 3 years (odds ratio [OR] = 2.47, 95% confidence interval [CI] = 1.33 to 4.57; P = .004); however, this association was no longer statistically significant at 5-year follow-up (OR = 1.19, 95% CI = 0.56 to 2.54; P = .7). Conclusions In this population-based sample of men with localized prostate cancer, we observed associations between financial burden and treatment regret. Our findings suggest indirect treatment costs, especially during the first 3 years after diagnosis, may impact patients more profoundly than direct costs and are important for inclusion in shared decision making.

PURPOSE: We aim to compare patient-reported mental health outcomes for men undergoing treatment for localized prostate cancer, longitudinally over 5 years. MATERIALS & METHODS: We conducted a prospective population-based analysis using the Comparative Effectiveness Analysis of Surgery and Radiation study (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 clinicopathologic characteristics, and treatment approach. RESULTS: 2742 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.

PurposeThe 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 methodsUsing 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.ResultsFor 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.ConclusionsOur 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.

Prior studies have shown significant variability in the quality of prostate cancer care in the US with questionable associations between quality measures and patient reported outcomes. We evaluated the impact of compliance with nationally recognized radiation therapy (RT) quality measures on patient-reported health-related quality of life (HRQOL) outcomes in the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) cohort.CEASAR is a population-based, prospective cohort study of men with localized prostate cancer from which we identified 649 who received primary RT and completed HRQOL surveys for inclusion. Eight quality measures were identified based on national guidelines. We analyzed the impact of compliance with these measures on HRQOL assessed by the 26-item Expanded Prostate Index Composite at pre-specified intervals up to 5 years after treatment. Multivariable analysis was performed controlling for demographic and clinicopathologic features.Among eligible participants, 566 (87%) patients received external beam radiation therapy and 83 (13%) received brachytherapy. Median age was 69 years (interquartile range: 64-73), 33% had low-, 43% intermediate-, and 23% high-risk disease. 28% received care non-compliant with at least one measure. In multivariable analyses, while some statistically significant associations were identified, there were no clinically significant associations between compliance with evaluated RT quality measures and patient reported urinary irritative, urinary incontinence, bowel, sexual or hormonal function.Compliance with RT quality measures was not meaningfully associated with patient-reported outcomes after prostate cancer treatment. Further work is needed to identify patient-centered quality measures of prostate cancer care.

Importance Treatment-related regret is an integrative, patient-centered measure that accounts for morbidity, oncologic outcomes, and anxiety associated with prostate cancer diagnosis and treatment. Objective To assess the association between treatment approach, functional outcomes, and patient expectations and treatment-related regret among patients with localized prostate cancer. Design, setting, and participants This population-based, prospective cohort study used 5 Surveillance, Epidemiology, and End Results (SEER)-based registries in the Comparative Effectiveness Analysis of Surgery and Radiation cohort. Participants included men with clinically localized prostate cancer from January 1, 2011, to December 31, 2012. Data were analyzed from August 2, 2020, to March 1, 2021. Exposures Prostate cancer treatments included surgery, radiotherapy, and active surveillance. Main outcomes and measures Patient-reported treatment-related regret using validated metrics. Regression models were adjusted for demographic and clinicopathologic characteristics, treatment approach, and patient-reported functional outcomes. Results Among the 2072 men included in the analysis (median age, 64 [IQR, 59-69] years), treatment-related regret at 5 years after diagnosis was reported in 183 patients (16%) undergoing surgery, 76 (11%) undergoing radiotherapy, and 20 (7%) undergoing active surveillance. Compared with active surveillance and adjusting for baseline differences, active treatment was associated with an increased likelihood of regret for those undergoing surgery (adjusted odds ratio [aOR], 2.40 [95% CI, 1.44-4.01]) but not radiotherapy (aOR, 1.53 [95% CI, 0.88-2.66]). When mediation by patient-reported functional outcomes was considered, treatment modality was not independently associated with regret. Sexual dysfunction, but not other patient-reported functional outcomes, was significantly associated with regret (aOR for change in sexual function from baseline, 0.65 [95% CI, 0.52-0.81]). Subjective patient-perceived treatment efficacy (aOR, 5.40 [95% CI, 2.15-13.56]) and adverse effects (aOR, 5.83 [95% CI, 3.97-8.58]), compared with patient expectations before treatment, were associated with treatment-related regret. Other patient characteristics at the time of treatment decision-making, including participatory decision-making tool scores (aOR, 0.80 [95% CI, 0.69-0.92]), social support (aOR, 0.78 [95% CI, 0.67-0.90]), and age (aOR, 0.78 [95% CI, 0.62-0.97]), were significantly associated with regret. Results were comparable when assessing regret at 3 years rather than 5 years. Conclusions and relevance The findings of this cohort study suggest that more than 1 in 10 patients with localized prostate cancer experience treatment-related regret. The rates of regret appear to differ between treatment approaches in a manner that is mediated by functional outcomes and patient expectations. Treatment preparedness that focuses on expectations and treatment toxicity and is delivered in the context of shared decision-making should be the subject of future research to examine whether it can reduce regret.

Aim: To assess health care professionals’ (HCP) perceptions of feasibility, acceptability, and impacts of a new digital patient-reported outcome (PRO) dialogue tool in routine diabetes care. Methods: A single-arm implementation study (MPRODIA) evaluating use of a PRO tool by 33 HCP in routine multi-sector diabetes care. Intervention: Persons with diabetes (PWD) filled out a digital questionnaire about health, well-being and self-care 1-8 days prior to the visit and their HCP used a PRO dialogue dashboard in the visit to facilitate a collaborative, person-centered dialogue. Primary outcome in this sub study was HCP responses to a clinical end-of-study Likert-Scale and Free-Text evaluation survey. Quantitative and explanatory qualitative data analyses were done with SPSS 25.0/Nvivo 12. Results: 33 HCP at 7 unique sites used PRO in 474 diabetes visits and completed the end-of-study survey. 80% were diabetes specialized, 67% saw>10 PWD/week, 33% had Conclusions: HCP in both municipality and hospital settings found a new digital PRO diabetes tool to be highly acceptable and value-adding by improving the active participation of PWD and the delivery of quality person-centered care. Disclosure S. E. Skovlund: None. D. M. Hessler: Consultant; Self; Eli Lilly and Company. S. H. Kaplan: None. N. Ejskjaer: None. C. Glümer: None. S. H. Nielsen: None. D. B. Berthelsen: None. H. Perrild: n/a. N. C. Balk-møller: None. L. Nørgaard: None. L. Troelsen: None. A. Pietraszek: None. Funding Danish Health Data Authority

The purpose of this study is to compare postoperative pain scores between children undergoing tonsillectomy and adenoidectomy (TA) surgery and their parents, identify potential predictors for this disagreement, and determine possible impact on analgesic administration.This is a prospective longitudinal study conducted with children undergoing outpatient TA in 4 major tertiary hospitals and their parents. Children and their parents were enrolled prior to surgery and completed baseline psychological instruments assessing parental anxiety (STAI), parental coping style (MBSS), child temperament (EAS) and parental medication administration attitude questionnaire (MAQ). Postoperatively, parents and children completed at-home pain severity ratings (Faces Pain Scale-Revised, children; Numeric Rating Scale, parents) on postoperative recovery days 1, 2, and 3, reflecting an overall pain level for the past 24 h. Parents also completed a log of analgesic administration. Based on postoperative pain scores, parent-child dyads were classified as overestimators (i.e., parents rated their child's pain higher than children rated their own pain), in agreement (i.e., rating in agreement), or underestimators (i.e., parents rated their child's pain lower than children rated their own pain).A significant proportion of parent-child pairs disagreed on pain ratings on postoperative days 1-3 (30.05%-35.95%). Of those pairs in disagreement, the majority of parents overestimated their child's pain on all three postoperative days, specifically such that a total of 24-26% parents overestimated their child's pain on postoperative days 1, 2, and 3. Repeated measures ANOVA demonstrated that parents in the overestimator group administered higher, though still within safe limits, amounts of ibuprofen and oxycodone (mg/day) than did the underestimator or agreement groups. Multiple regression models showed hospital site as the only independent predictor for postoperative pain rating disagreement between children and parents.Since parents overestimate their child's postoperative pain and may administer more analgesics to their child, it is essential to develop a standardized method of child pain assessment and a tailored recommended postoperative analgesic regimen amongst medical providers for children undergoing TA.

BackgroundThe role of pelvic irradiation in men receiving external beam radiotherapy (EBRT) for prostate cancer is unclear, in part due to a lack of data on patient-reported outcomes. We sought to compare functional outcomes for men receiving prostate and pelvic versus prostate-only radiotherapy, longitudinally over 5 years.Materials and methodsWe performed a population-based, prospective cohort study of men with clinically-localized prostate cancer undergoing EBRT. We examined the effect of prostate and pelvic (n = 102) versus prostate-only (n = 485) radiotherapy on patient-reported disease-specific (using the Expanded Prostate Cancer Index Composite[EPIC]-26) and general health-related (using the SF-36) function, over 5 years. Regression models were adjusted for outcome-specific baseline function, clinicopathologic characteristics, and androgen deprivation therapy (ADT).Results587 men (median [quartiles] age 69 [64-73] years) met inclusion criteria and completed ≥1 post-treatment survey. More men treated with prostate and pelvic radiotherapy had high-risk disease (58% vs. 18%, P < 0.01) and received ADT (75% vs. 41%, P < 0.01). These men reported worse sexual (6 months-5 years), hormonal (at 6 months), and physical (6 months-5 years) function. Accounting for baseline function, patient and tumor characteristics, and use of ADT, pelvic irradiation was not associated with statistically or clinically significant differences in bowel function, urinary incontinence, irritative voiding symptoms or sexual function through 5-years (all P > 0.05). Marginally clinically important differences were noted in hormonal function at 3-years (adjusted mean difference 4.7, 95% confidence interval [1.2-8.3]; minimally clinically important difference (MCID) 4 to 6) and 5-years (4.2, [0.4-8.0]) following treatment. After adjustment, there was a transient statistically significant, but not clinically important, difference in emotional well-being at 6 months (3.0, [0.19-5.8]; MCID 6) that resolved by 1 year and no differences in physical functioning or energy and fatigue.ConclusionThis prospective, population-based cohort study of men with localized prostate cancer treated with EBRT, showed no clinically important differences in disease-specific or general health-related quality of life with the addition of pelvic irradiation to prostate radiotherapy, supporting the use of pelvic radiotherapy when it may be of clinical benefit, such as men with increased risk of nodal involvement.

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.

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.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.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.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.

Aim: To develop a protocol and set of purpose-built psychometric PRO evaluation questionnaires for a national multi-sector study to evaluate feasibility, acceptability, validity, barriers, facilitators and perceived value of the National Danish PRO diabetes intervention (PRO diabetes questionnaire and dialogue tool) in Denmark. Methods: The protocol was designed through a participatory process with People With Diabetes (PWD), multi-disciplinary representatives of diabetes centres and municipality diabetes rehabilitation centres from 3 regions of Denmark. Hypotheses and assessment tools were guided by formative qualitative research. The intervention involved that PWD fill out the PROM prior to their visit and the Health Care Professional (HCP) uses a PRO IT dialogue tool to collaboratively evaluate needs and plan care. Results: The pragmatic mixed-methods study protocol involved hypothesis testing and exploratory research: 1) PRO-DIA-READY Scales for Clinic and HCP PRO-Diabetes Readiness (incl. structural/process indicators of person-centred care). 2) 6-item PRO-EVAL-P Scale completed by PWD after the PROM. 3) 8-item PROCON-EVAL-HCP and 13-item PROCON-EVAL-PWD scales completed by HCPs and PWD after the visit, 4) Clinician rating scales of PROM validity 5) Semi-structured interview/group workshop guides for PWD, Caregivers (CG), multi-disciplinary HCPs, and administrators based on RE-AIM: Reach, Effectiveness, Adoption, Implementation and Maintenance, 6) HCP/PWD Follow-Up Impact Questionnaires (incl. active participation, person-centred care, care utilisation and outcomes). Newly designed evaluation scales were analyzed psychometrically. Conclusions: A protocol and new psychometric assessment tools for evaluation of validity, readiness, acceptability and impact of PRO in diabetes care were developed and successfully applied in large scale in Denmark. The new tools are available for comparative PRO research studies. Disclosure S.E. Skovlund: None. L. Boel: None. N.C. Balk-Møller: None. P.M. Højholt: None. D.B. Berthelsen: None. C. Glümer: None. H. Perrild: None. D.M. Hessler: Consultant; Self; Eli Lilly and Company. S.H. kaplan: None. P.O. Jakobsen: None. N. Ejskjaer: None. Funding Danish Health Data Board

Introduction and objectiveThe timing of radiotherapy (RT) after prostatectomy is controversial, and its effect on sexual, urinary, and bowel function is unknown. This study seeks to compare patient-reported functional outcomes after radical prostatectomy (RP) and postprostatectomy radiation as well as elucidate the timing of radiation to allow optimal recovery of function.MethodsThe Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, observational study of men with localized prostate cancer. Patient-reported sexual, urinary, and bowel functional outcomes were measured using the 26-item Expanded Prostate Index Composite at baseline and at 6, 12, 36, and 60 months after enrollment. Functional outcomes were compared among men undergoing RP alone, post-RP adjuvant radiation (RP + aRT), and post-RP salvage radiation (RP + sRT) using multivariable models controlling for baseline clinical, demographic, and functional characteristics.ResultsAmong 1,482 CEASAR participants initially treated with RP for clinically localized prostate cancer, 11.5% (N = 170) received adjuvant (aRT, N = 57) or salvage (sRT, N = 113) radiation. Men who received post-RP RT had worse scores in all domains (sexual function [-9.0, 95% confidence interval {-14.5, -3.6}, P < 0.001], incontinence [-8.8, {-14.0, -3.6}, P < 0.001], irritative voiding [-5.9, {-9.0, -2.8}, P < 0.001], bowel irritative [-3.5, {-5.8, -1.2}, P = 0.002], and hormonal function [-4.5, {-7.2, -1.7}, P = 0.001]) compared to RP alone at 5 years of follow-up. Compared to men treated with RP alone in an adjusted linear model, sRT was associated with significantly worse scores in all functional domains. aRT was associated with significantly worse incontinence, urinary irritation, and hormonal function domain scores compared to RP alone at 5 years of follow-up. On multivariable modeling, RT administered approximately 24 months after RP was associated with the smallest decline in sexual domain score, with an adjusted mean decrease of 8.85 points (95% confidence interval [-19.8, 2.1]) from post-RP, pre-RT baseline.ConclusionsIn men with localized prostate cancer, post-RP RT was associated with significantly worse sexual, urinary, and bowel function domain scores at 5 years compared to RP alone. Radiation delayed for approximately 24 months after RP may be optimal for preserving erectile function compared to radiation administered closer to the time of RP.

Background Shared decision making to guide treatment of localized prostate cancer requires delivery of the anticipated quality of life (QOL) outcomes of contemporary treatment options (including radical prostatectomy [RP], intensity-modulated radiation therapy [RT], and active surveillance [AS]). Predicting these QOL outcomes based on personalized features is necessary. Objective To create an easy-to-use tool to predict personalized sexual, urinary, bowel, and hormonal function outcomes after RP, RT, and AS. Design, setting, and participants A prospective, population-based cohort study was conducted utilizing US cancer registries of 2563 men diagnosed with localized prostate cancer in 2011–2012. Intervention Patient-reported urinary, sexual, and bowel function up to 5 yr after treatment. Outcome measurements and statistical analysis Patient-reported urinary, sexual, bowel, and hormonal function through 5 yr after treatment were collected using the 26-item Expanded Prostate Index Composite (EPIC-26) questionnaire. Comprehensive models to predict domain scores were fit, which included age, race, D'Amico classification, body mass index, EPIC-26 baseline function, treatment, and standardized scores measuring comorbidity, general QOL, and psychosocial health. We reduced these models by removing the instrument scores and replacing D'Amico classification with prostate-specific antigen (PSA) and Gleason score. For the final model, we performed bootstrap internal validation to assess model calibration from which an easy-to-use web-based tool was developed. Results and limitations The prediction models achieved bias-corrected R-squared values of 0.386, 0.232, 0.183, 0.214, and 0.309 for sexual function, urinary incontinence, urinary irritative, bowel, and hormonal domains, respectively. Differences in R-squared values between the comprehensive and parsimonious models were small in magnitude. Calibration was excellent. The web-based tool is available at https://statez.shinyapps.io/PCDSPred/. Conclusions Functional outcomes after treatment for localized prostate cancer can be predicted at the time of diagnosis based on age, race, PSA, biopsy grade, baseline function, and a general question regarding overall health. Providers and patients can use this prediction tool to inform shared decision making. Patient summary In this report, we studied patient-reported sexual, urinary, hormonal, and bowel function through 5 yr after treatment with radical prostatectomy, radiation therapy, or active surveillance for localized prostate cancer. We developed a web-based predictive tool that can be used to predict one's outcomes after treatment based on age, race, prostate-specific antigen, biopsy grade, pretreatment baseline function, and a general question regarding overall health. We hope both patients and providers can use this tool to better understand expected outcomes after treatment, further enhancing shared decision making between providers and patients.

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.

OBJECTIVES/HYPOTHESIS We developed and validated a septal deformity grading (SDG) system that accounts for anatomic location and grading of deformity severity. STUDY DESIGN Retrospective cohort study. METHODS Subjects were patients with nasal obstruction presenting to University of California, Irvine Medical Center. Subjects were given pre- and postoperative Nasal Obstruction Symptom Evaluation (NOSE) questionnaires and were evaluated by a facial plastic surgeon using our septal deformity grading (SDG) system. Validity and reliability analyses were conducted on the SDG results. Statistical analyses were conducted on SDG and NOSE data to assess and compare instruments, and to validate the SDG instrument using the NOSE instrument. RESULTS One hundred thirty-five patients met inclusion criteria. Cronbach's α was ≥ 0.7 for SDG and pre- and postoperative NOSE scores. There was a significant difference in pre- and postoperative NOSE scores (Z score = -7.21, P

Introduction: Little is known about differences in patient reported outcomes between contemporary external beam radiation therapy for localized prostate cancer that delivers higher doses of...

Bladder trabeculation (BT) is commonly noted on cystogram images of patients with neurogenic bladder (NB). BT is associated with a hostile bladder often requiring prompt, more aggressive management. We aimed to define and validate a reliable grading system for BT severity. The proposed grading system will improve clinicians and radiologist's communication and serve as a foundation for future studies in the field of NB. The study was conducted in two phases: 1) Development of a grading system for BT and 2) testing of the proposed grading system for reliability and validity. Agreement between raters was assessed using Cohen's Kappa. Inter-rater reliability and intra-rater reliability was assessed using intra-class correlation coefficients (ICC) and Spearman's p (rho) correlation coefficient. The content of the grading system was assessed for face validity by senior pediatric urology and radiology experts. We observed inter-rater reliability with ICC of 0.998 (95%CI 0.996-0.999, p 0.001), and a Cohen's Kappa ranging from 0.795 to 1.0, p 0.001 and Spearman's p (rho) correlation coefficient ranging from 0.910 to 1.0, p 0.001 between raters on the decided grades of BT. In conclusion, we established a defined grading system for BT severity that has substantial inter/intra-rater reliability and validity. This grading system could be useful for improving clinician and radiologist's communication about the status of a child's bladder wall and serve as a foundation for future studies assessing severity of NB.

Objective To evaluate the influence of psychosocial factors such as prostate cancer (PCa) anxiety, social support, participation in medical decision-making (PDM), and educational level on patient decisions to discontinue PCa active surveillance (AS) in the absence of disease progression. Methods The Comparative Effectiveness Analysis of Surgery and Radiation study is a prospective, population-based cohort study of men with localized PCa diagnosed in 2011-2012. PCa anxiety, social support, PDM, educational level, and patient reasons for discontinuing AS were assessed through patient surveys. A Cox proportional hazards model examined the relationship between psychosocial variables and time to discontinuation of AS. Results Of 531 patients on AS, 165 (30.9%) underwent treatment after median follow-up of 37 months. Whereas 69% of patients cited only medical reasons for discontinuing AS, 31% cited at least 1 personal reason, and 8% cited personal reasons only. Patients with some college education discontinued AS significantly earlier (hazard ratio: 2.0, 95% confidence interval: 1.2, 3.2) than patients with less education. PCa anxiety, social support, and PDM were not associated with seeking treatment. Conclusion We found that 31% of men who choose AS for PCa discontinue AS within 3 years. Eight percent of men who sought treatment did so in the absence of disease progression. Education, but not psychosocial factors, seems to influence definitive treatment-seeking. Future research is needed to understand how factors unrelated to disease severity influence treatment decisions among patients on AS to identify opportunities to improve adherence to AS.

Urologists have been criticized for overtreating men with low risk prostate cancer and for passively observing older men with higher risk disease. Proponents of active surveillance for low risk disease and critics of watchful waiting for higher risk disease have advocated for more judicious use of observation. Thus, we compared 2 population based cohorts to determine how expectant management has evolved during the last 2 decades.A total of 5,871 men with localized prostate cancer were enrolled in the PCOS (Prostate Cancer Outcomes Study) or the CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study. We compared the use of definitive treatment vs expectant management (watchful waiting or active surveillance) across cohorts, focusing on the influence of disease risk, age and comorbidities.Use of watchful waiting or active surveillance was similar in PCOS and CEASAR (14% in each). Compared to the PCOS, more men in the CEASAR study with low risk disease selected watchful waiting or active surveillance (25% vs 15%, respectively), whereas fewer men with intermediate (7% vs 14%) and high risk (3% vs 10%) disease chose watchful waiting or active surveillance (p0.001 for each). The association of disease risk with watchful waiting or active surveillance was significantly larger in CEASAR than in PCOS (OR 7.3, 95% CI 3.4 to 15.7). Older age was associated with watchful waiting or active surveillance in both cohorts but there was no association between comorbidity and watchful waiting or active surveillance in the CEASAR study.Use of watchful waiting or active surveillance was more aligned with disease risk in CEASAR compared to PCOS, suggesting there has been a pivot from watchful waiting to active surveillance. While older men were more likely to be observed, comorbidity had little, if any, influence.

Although comorbidities have a well-known impact on the functional recovery of patients with disorders of consciousness, including coma, vegetative state (VS), and minimally conscious state (MCS), a specific tool for their assessment in this challenging group of patients is lacking. For this aim, a multistep process was used to develop and validate the Comorbidities Coma Scale (CoCoS) in a sample of 162 patients with a diagnosis of coma, VS or MCS admitted to four Acute Inpatient Rehabilitation Units. To establish the psychometric properties of the scale, content validity, and internal consistency were investigated through Exploratory Factor Analysis in the whole sample (n = 162). Interrater reliability, assessed by the weighted Cohen's kappa (Kw), and concurrent validity of the scale as compared to the Greenfield Scale, assessed by ρ Spearman's correlation coefficient, were investigated in a subsample of patients (n = 52) within two of the above units. Our findings provided evidence of a good content validity of the scale, with the identification of a 12-factor structure representing the different comorbid dimensions of the target population. Inter-rater reliability was excellent in both the rehabilitation units where the assessment was made [Kw 0.98 (95% CI 0.96–0.99)]. CoCoS total scores correlated significantly with total scores of the Greenfield Scale (ρ = 0.932, 95% CI 0.89–0.96; P < 0.0001) indicating that CoCoS has concurrent validity while being more informative about the specific pattern of comorbidities of these challenging patients. The CoCos is a new tool which standardizes the approach to assessment of comorbid conditions and reliably identifies the category and severity of each comorbidity detected. It may be used for both clinical and research applications.

Background: Recent efforts to study quality improvement (QI) efforts to improve the effectiveness and efficiency of healthcare have raised important questions about ethical boundaries for waiving informed consent. Confusion exists because similar projects can be undertaken for research or QI purposes, a distinction currently used to define Institutional Review Board oversight. However, patients are not aware of such distinctions. We sought to evaluate patients' views of waiving consent for non-invasive projects to improve healthcare quality and delivery. Methods: We developed a 32-item measure of patient thresholds for waiving consent for different types of QI interventions, including those involving changes to: 1) the hospital environment; 2) hospital policies or procedures; 3) objects used by patients; 4) medications or devices; and 5) use of patient information. In a sample of 200 hospitalized patients, we tested and confirmed the reliability and validity of subscales representing each of the 5...

302 Background: Matching of patients with optimal treatment for localized prostate cancer (PCa) requires accurate estimates of risk for progression or recurrence. Traditional risk assessment methods may underestimate risk for certain patient subgroups, (e.g. minorities). In the PMPC study, we replicated an expanded risk model, adding genomic data to improve risk prediction and optimize treatment assignment for PCa. Methods: A prospective cohort of 660 patients with early PCa was identified from 3 teaching hospitals and 2 VA Hospitals in Southern California. Risk model data were collected from electronic medical records, patient questionnaires and tissue-based genomic data provided by GenomeDx. Complexity variables included demographic characteristics, clinical markers (PSA levels, Gleason score), patient-reported health status measures (e.g. comorbidity burden, depression, stress) and Decipher score. We compared individual components of the complexity score for 425 Non-Hispanic White (NHW) and 104 African American (AA) men using t-tests. Composite complexity scores were derived from weights from general linear models. Mean complexity scores were compared using t-tests. Results: Compared with NHW men, AA men had statistically significantly more comorbidity, poorer health ratings, poorer physical functioning, more depression, less energy, more fatigue, more stress and less resilience. More AA men had Gleason scores >6 (60.0%) than NHW men (46.6%), p=.0134. Fewer AA men (41.5%) had ‘low risk’ Decipher scores compared to NHW men (53.8%). More AA men had high complexity scores compared with NHW men (63.4% vs. 45.1%, p=.008), however, there were no statistically significant differences in the proportion of NHW vs. AA men on active surveillance, 46.0% vs. 40.7%, p=.384. Using clinical variables alone there were no significant differences in low risk between NHW and AA men. Conclusions: The addition of genomic data improved the complexity model developed earlier. AA men may be at higher risk for suboptimal treatment than predicted by clinical variables alone. Data from the longitudinal cohort will test accuracy of model prediction for disease progression or recurrence. Clinical trial information: NCT03770351.

PurposeTo compare patient-reported disease-specific functional outcomes after external beam radiation therapy (EBRT) and EBRT combined with low-dose-rate brachytherapy prostate boost (EB-LDR) among men with localized prostate cancer.Methods and materialsThe prospective, population-based Comparative Effectiveness Analysis of Surgery and Radiation study enrolled men with localized prostate cancer in 2011 to 2012. The 26-item Expanded Prostate Cancer Index Composite measured patient-reported disease-specific function at baseline and at 6, 12, and 36months. Higher domain scores indicate better function. Minimal clinically important difference was defined as 6 for urinary incontinence, 5 for urinary irritative function, 4 for bowel function, 12 for sexual function, and 4 for hormonal function. Multivariable linear and logistic regression models were fit to estimate the effect of treatment on patient-reported outcomes.ResultsFive-hundred seventy-eight men received EBRT and 109 received EB-LDR. Median patient age was 69years, and 70% had intermediate- or high-risk disease. Men in the EB-LDR group were younger (P.05). On multivariable analyses, men receiving EB-LDR reported worse urinary irritative function at 6months (adjusted mean difference [AMD] -14.4, P&nbsp

© 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved. Background Despite the paramount importance of patient-reported outcomes, little is known about the evolution of patient-reported urinary and sexual function over time. Objective To evaluate differences in pretreatment urinary and sexual function in two population-based cohorts of men with prostate cancer enrolled nearly 20 yr apart. Design, setting, and participants Patients were enrolled in the Prostate Cancer Outcomes Study (PCOS) or the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study, two population-based cohorts that enrolled patients with incident prostate cancer from 1994 to 1995 and from 2011 to 2012, respectively. Participants completed surveys at baseline and various time points thereafter. Outcome measurements and statistical analysis We performed multivariable logistic and linear regression analysis to investigate differences in pretreatment function between studies. Results and limitations The study comprised 5469 men of whom 2334 (43%) were enrolled in PCOS and 3135 (57%) were enrolled in CEASAR. Self-reported urinary incontinence was higher in CEASAR compared with PCOS (7.7% vs 4.7%; adjusted odds ratio [OR]: 1.83; 95% confidence interval [CI], 1.39-2.43). Similarly, self-reported erectile dysfunction was more common among CEASAR participants (44.7% vs 24.0%) with an adjusted OR of 3.12 (95% CI, 2.68-3.64). Multivariable linear regression models revealed less favorable self-reported baseline function among CEASAR participants in the urinary incontinence and sexual function domains. The study is limited by its observational design and possibility of unmeasured confounding. Conclusions Reporting of pretreatment urinary incontinence and erectile dysfunction has increased over the past two decades. These findings may reflect sociological changes including heightened media attention and direct-to-consumer marketing, among other potential explanations. Patient summary Patient reporting of urinary and sexual function has evolved and is likely contingent on continually changing societal norms. Recognizing the evolving nature of patient reporting is essential in efforts to conduct high-quality, impactful comparative effectiveness research.

Summary 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.

AimsTo 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.MethodsSecondary 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.ResultsResults 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 (βs = 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).ConclusionsMental 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.

The editorialists discuss the synopsis of the joint U.S. Department of Veterans Affairs/U.S. Department of Defense guidelines on management of type 2 diabetes. They also explore the sources of conf...

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.

Understanding the adverse effects of contemporary approaches to localized prostate cancer treatment could inform shared decision making.To compare functional outcomes and adverse effects associated with radical prostatectomy, external beam radiation therapy (EBRT), and active surveillance.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.Treatment with radical prostatectomy, EBRT, or active surveillance was ascertained within 1 year of diagnosis.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.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%).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.

PURPOSE OF STUDY In response to the U.S. Affordable Care Act, the Centers for Medicare & Medicaid Services proposed a change in reimbursement penalties for hospitals beginning October 1, 2012. Reducing the occurrence of unplanned readmissions has become a more urgently focused topic. As part of the health care system, care management aligns with physicians to significantly improve service, financial, and clinical care outcomes. To address the changing health care climate in 2008, care management services were restructured at an academic university medical center located in 1 of the 3 largest counties in California. Changing from a unit-based to a service-based care management model partnered care managers and social workers with physician services. We sought to assess the effect of this change on surrogates for patient experience and clinical quality of care. PRIMARY PRACTICE SETTING Tertiary academic medical center in southern California. METHODOLOGY AND SAMPLE Retrospective data were collected from 2 databases for all hospital patient care services from November 2008 to January 2010 to determine whether clinical quality of care and experiential service improvements were realized. Primary outcomes included all-cause and related readmission rates. Secondary outcomes were Hospital Consumer Assessment of Healthcare Providers and Systems (H-CAHPS) scores. An interrupted time series analysis compared data from the single institution for the diffusion and postintervention periods. RESULTS Comparing data from the diffusion and postintervention periods, the rate of disease-related readmissions decreased significantly (mean 5.43-4.58, p < .05), and all-cause readmissions also decreased, although the difference failed to achieve statistical significance (11.42-10.49, p = .056). H-CAHPS scores with the patient response of "recommend this hospital" was unchanged over the 2 time points (mean 78.9%-77.8%, p = .26731). Data also showed stable care management staffing rates whereas average daily census (ADC) increased over time (ADC 274-297). IMPLICATIONS FOR CASE MANAGEMENT PRACTICE With health reform driving value-driven care transformation, partnering care managers and social workers with physician services has the potential to impact the patient's experience as well as financial and clinical care outcomes. Care managers serve a significant role in improving the clinical quality of care by reinforcing a consistent and clear message by the health care team to the patient during the entire hospitalization, not just at the time of discharge. At one institution, partnering physicians with care managers through the acute care continuum (service-based care management) appeared to reduce readmissions without compromising patient satisfaction. Both readmission reduction and effective patient satisfaction scores impact the Centers for Medicare & Medicaid Services value-based purchasing reimbursement calculations.

Aim: To assess the ability of ENterprising SElective Multi-instrument BLend for hEterogeneity analysis (ENSEMBLE) Minimum Dataset instrument dimensions to discriminate among subgroups of patients expected to have differential outcomes. Materials & methods: Patients with Type 2 diabetes, knee osteoarthritis, ischemic heart disease or heart failure completed a survey designed to represent three dimensions (health, personality and behavior). Health-related outcomes and utilization were investigated using claims data. Discriminant validity and associations between the dimensions and outcomes were assessed. Results: A total of 2625 patients completed the survey. The dimensions discriminated 50–100% of the outcome levels across disease cohorts; behavior dimension scores did not differ significantly among the healthcare utilization level subgroups in any disease cohort. Conclusion: ENSEMBLE Minimum Dataset dimensions discriminated health-related outcome levels among patients with varied diseases.

© Meharry Medical College. Purpose. This study examines the use of complementary and alternative medicine (CAM) by ethnicity/race among patients with type 2 diabetes. Subjects and methods. Four hundred and ten (410) patients with type 2 diabetes recruited from an academic-medical center completed a survey assessing CAM use, diabetes status, and sociodemographic characteristics. Results. Several significant ethnic/racial differences were observed in CAM use (both in the types of providers seen as well as in the herbs and dietary supplements used). Although White patients reported using CAM in addition to their diabetes medication (mean [SD] 4.9 [0.4] on a scale from 1=never to 5=always) more frequently than Mexican American patients (3.1 [1.6], p

BACKGROUND Despite numerous efforts to change healthcare delivery, the profile of disparities in diabetes care and outcomes has not changed substantially over the past decade.

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. Cancer 2013;119:2413-2418. © 2013 American Cancer Society.

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 (β=-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.