Early vs Delayed Transurethral Surgery in Acute Urinary Retention: Does Timing Make a Difference?

PURPOSE: Our goal was to compare outcomes of early vs delayed transurethral surgery for benign prostatic hyperplasia after an episode of acute urinary retention compared to men without preoperative acute retention. MATERIALS AND METHODS: We conducted a retrospective cohort analysis using data from the New York Statewide Planning and Research Cooperative System from 2002-2016. We identified men ≥40 years old who underwent primary ambulatory transurethral resection or photoselective vaporization of the prostate, assessing surgical failure as time to reoperation or recatheterization. We categorized presurgical acute urinary retention by number of episodes: none (reference), 1, or ≥2 precatheterizations, and time from first retention episode to surgery: none (reference), 0-6 months, and >6 months. We used Fine-Gray competing-risk models to predict surgical failure at 10 years, with presurgical acute retention as the primary predictor, adjusted for age, race, insurance, Charlson Comorbidity Index score, preoperative urinary infection, and procedure type, with death as the competing risk. RESULTS: Among 17,474 patients undergoing transurethral surgery, 10% had preoperative acute retention with a median time to surgery of 2.4 months (IQR: 1-18). Among men with preoperative retention, 37% had ≥6 months of delay to surgery. The 10-year cumulative treatment failure rate was 17.2% among catheter naïve men vs 34.0% with ≥2 precatheterizations and 32.9% with ≥6 months delay to surgery. Delays from catheterization to surgery were associated with higher rates of treatment failure (<6 months SHR 1.49, P < .001; ≥6 months SHR 2.11, P < .001) vs catheter naïve men. CONCLUSIONS: Preoperative acute urinary retention and delay to surgery once catheterized are associated with poorer long-term postoperative outcomes after surgery for benign prostatic hyperplasia.

A Claims Based Assessment of Reoperation and Acute Urinary Retention after Ambulatory Transurethral Surgery for Benign Prostatic Hyperplasia.

PURPOSE: We evaluated real-world use of common transurethral prostate procedures in the ambulatory surgical setting and compare subsequent rates of tr!eatment failure. MATERIALS AND METHODS: Using the New York Statewide Planning and Research Cooperative System database we identified men 40 years old or older undergoing ambulatory surgeries categorized as transurethral resection of the prostate, photoselective vaporization of the prostate, endoscopic enucleation or other (transurethral incision, microwave/radiofrequency ablation) from 2010 to 2016. Multivariate Cox proportional hazards regression was used to predict treatment failure, defined as reoperation or postoperative acute urinary retention greater than 30 days after procedure. RESULTS: We identified 15,982 men, median age 69 years (IQR 63-76), 61% of whom underwent photoselective vaporization of the prostate, 36% transurethral resection of the prostate, 1.5% endoscopic enucleation and 1.5% other transurethral prostate procedures from 2010 to 2016. At 7 years cumulative failure rates were 15.3% (transurethral resection of the prostate), 13.9% (photoselective vaporization of the prostate), 6.7% (endoscopic enucleation) and 17.8% (other procedures). Compared to transurethral resection of the prostate, photoselective vaporization of the prostate was not associated with increased hazards of treatment failure HR 1.07 (95% CI 0.93-1.22). Compared to transurethral resection of the prostate, endoscopic enucleation was associated with a nonsignificant trend toward lower treatment failure (HR 0.67, 95% CI 0.36-1.22), while other surgical modalities were associated with significantly higher treatment failure (HR 1.68. 95% CI 1.12-2.52). Among men treated from 2011 to 2012, endoscopic enucleations were associated with significantly lower failure than transurethral resection of the prostate (HR: 0.24, 95% CI 0.06-0.97). CONCLUSIONS: Supporting the generalizability of previous randomized trial findings, in real-world practice we found no differences in treatment failure up to 7 years after photoselective vaporization of the prostate or transurethral resection of the prostate. By comparison, endoscopic enucleation, although underused, may be associated with lower rates of treatment failure than transurethral resection of the prostate.

Prostate-specific antigen testing after the US Preventive Services Task Force recommendation: a population-based analysis of electronic health data.

PURPOSE: This study describes longitudinal trends in the use of prostate-specific antigen (PSA)-based testing in two geographically distinct healthcare systems following the 2011 US Preventive Services Task Force (USPSTF) recommendations against routine PSA screening. METHODS: We analyzed population-based health claims data from 253,139 men aged 40-80 who were enrolled at two US healthcare systems. We assessed trends in the percentage of eligible men receiving ≥ 1 PSA test per year by time period (2000-2008, 2009-2011, 2012-2014), age (40-54, 55-69, 70-80), and race (white, black, other, unknown), and conducted a joinpoint regression analysis. RESULTS: Men aged 55-69 and 70-80 years of all races had similar use of PSA testing between 2000 and 2011, ranging between 47 and 56% of eligible men by year, while only 22-26% of men aged 40-54 had a PSA test per year during this period. Overall, the percentage of men receiving at least one PSA test per year decreased by 26% between 2009-2011 and 2012-2014, with similar trends across race and age groups. PSA testing declined significantly after 2011 (annual percent change = - 11.28). CONCLUSIONS: Following the 2011 USPSTF recommendations against routine PSA screening, declines in PSA testing were observed among men of all races and across all age groups in two large US healthcare systems.

High Real-World Medication Adherence and Durable Clinical Benefit in Medicare Patients Treated with 5-Alpha Reductase Inhibitors for Benign Prostatic Hyperplasia.

PURPOSE: Although clinical trials demonstrate 5-alpha reductase inhibitors are efficacious treatments for benign prostatic hyperplasia, they have low reported medication adherence outside of clinical trials. We evaluated real-world drug adherence and clinical outcomes in Medicare patients with lower urinary tract symptoms from benign prostatic hyperplasia managed with 5-alpha reductase inhibitor therapy. MATERIALS AND METHODS: Using health care and pharmacy claims from Partners Healthcare Medicare Accountable Care Organization enrollees (January 2009 to July 2018), we identified men initiating a 5-alpha reductase inhibitor for benign prostatic hyperplasia with more than 1 medication dispensation. Adherence was calculated as an 80% or greater proportion of days covered. A Cox proportional hazards model was used to evaluate the primary outcome of treatment failure, defined as any benign prostatic hyperplasia related surgery. RESULTS: Among 3,107 men initiating 5-alpha reductase inhibitor therapy for benign prostatic hyperplasia and filling at least 2 prescriptions, 74.9% had high medication adherence during the first year. Patients with low adherence had 29% higher hazards of undergoing surgical intervention (95% CI 1.02-1.59, p=0.036) after adjusting for age, benign prostatic hyperplasia severity, presence of hematuria, bladder stones and type of 5-alpha reductase inhibitors. The presence of bladder stones (HR 1.70, 95% CI 1.02-2.86, p=0.04) and finasteride vs dutasteride use (HR 1.41, 95% CI 1.01-1.98, p=0.05) were also risk factors for surgical intervention. CONCLUSIONS: Among Medicare patients 5-alpha reductase inhibitor treatment adherence was high and associated with lower hazards of surgical intervention. 5-Alpha reductase inhibitor therapy may be more feasible for older men with benign prostatic hyperplasia than previously reported and demonstrates modest clinical benefit.

Patient-reported functional health and well-being outcomes with drug therapy: a systematic review of randomized trials using the SF-36 health survey.

OBJECTIVES: To evaluate the responsiveness of the SF-36 Health Survey in drug trials and to determine how often clinically efficacious treatments produce meaningful functional health changes across medical conditions. RESEARCH DESIGN: We conducted a systematic review of randomized, double-blind, placebo-controlled drug trials published from 1995 to 2011 that documented results for primary clinical endpoints and SF-36 outcomes. PubMed and a database of SF-36 publications were searched. We evaluated responsiveness as concordance (both statistically significant or both nonsignificant) between primary clinical and SF-36 outcomes. To determine how often SF-36 physical and mental component summary (PCS, MCS) score changes were of meaningful magnitude, mean net of placebo changes with treatment were compared against the developer's recommended 3-point threshold for a minimal important difference (MID) across groups of medical conditions. RESULTS: Of 805 screened trials, 185 met eligibility criteria. Primary clinical and SF-36 outcomes were concordant in 151 trials (82%). Among clinically efficacious trials, 58% reported net mean SF-36 improvements ≥MID threshold; however, SF-36 changes were often modest (PCS IQR, 1.6-4.1; MCS IQR, 0.8-3.5). Variations in treatment impact were apparent across conditions. Clinically efficacious therapies for rheumatoid arthritis, psoriatic arthritis, and psoriasis consistently achieved the largest SF-36 improvements, with 87% exceeding MID, whereas no efficacious therapies for peripheral arterial disease or chronic obstructive pulmonary disease achieved MID threshold. CONCLUSIONS: The SF-36 responds to treatment impact, distinguishing drug therapies that, on average, produce meaningful functional health benefits. Overall, just over half of clinically efficacious trials report meaningful functional health improvements, and results vary widely by medical condition.

Association of BCG Vaccine Treatment With Death and Dementia in Patients With Non-Muscle-Invasive Bladder Cancer.

Importance: The BCG vaccine-used worldwide to prevent tuberculosis-confers multiple nonspecific beneficial effects, and intravesical BCG vaccine is currently the recommended treatment for non-muscle-invasive bladder cancer (NMIBC). Moreover, BCG vaccine has been hypothesized to reduce the risk of Alzheimer disease and related dementias (ADRD), but previous studies have been limited by sample size, study design, or analyses. Objective: To evaluate whether intravesical BCG vaccine exposure is associated with a decreased incidence of ADRD in a cohort of patients with NMIBC while accounting for death as a competing event. Design, Setting, and Participants: This cohort study was performed in patients aged 50 years or older initially diagnosed with NMIBC between May 28, 1987, and May 6, 2021, treated within the Mass General Brigham health care system. The study included a 15-year follow-up of individuals (BCG vaccine treated or controls) whose condition did not clinically progress to muscle-invasive cancer within 8 weeks and did not have an ADRD diagnosis within the first year after the NMIBC diagnosis. Data analysis was conducted from April 18, 2021, to March 28, 2023. Main Outcomes and Measures: The main outcome was time to ADRD onset identified using diagnosis codes and medications. Cause-specific hazard ratios (HRs) were estimated using Cox proportional hazards regression after adjusting for confounders (age, sex, and Charlson Comorbidity Index) using inverse probability scores weighting. Results: In this cohort study including 6467 individuals initially diagnosed with NMIBC between 1987 and 2021, 3388 patients underwent BCG vaccine treatment (mean [SD] age, 69.89 [9.28] years; 2605 [76.9%] men) and 3079 served as controls (mean [SD] age, 70.73 [10.00] years; 2176 [70.7%] men). Treatment with BCG vaccine was associated with a lower rate of ADRD (HR, 0.80; 95% CI, 0.69-0.99), with an even lower rate of ADRD in patients aged 70 years or older at the time of BCG vaccine treatment (HR, 0.74; 95% CI, 0.60-0.91). In competing risks analysis, BCG vaccine was associated with a lower risk of ADRD (5-year risk difference, -0.011; 95% CI, -0.019 to -0.003) and a decreased risk of death in patients without an earlier diagnosis of ADRD (5-year risk difference, -0.056; 95% CI, -0.075 to -0.037). Conclusions and Relevance: In this study, BCG vaccine was associated with a significantly lower rate and risk of ADRD in a cohort of patients with bladder cancer when accounting for death as a competing event. However, the risk differences varied with time.

Primary care physician's (PCP) perceived value of patient-reported outcomes (PROs) in clinical practice: a mixed methods study.

BACKGROUND: Patient-reported outcomes (PROs) can promote patient engagement, shared-decision making and improve the overall experience of care. However, PRO integration in the primary care clinical setting is limited. Exploring the perspectives of primary care physicians (PCPs) on PROs is key to understanding how they are being used in the clinical setting. We sought to elucidate this clinical perspective at one of the largest US health systems that has integrated a wide range of PROs into routine primary care. METHODS: Mixed methods study with both anonymous online surveys and in-person qualitative semistructured interviews conducted with PCPs to understand their clinical perspectives on the applications of the existing PROs. PCPs from the 19 affiliated clinics were prompted to complete the survey. Interviewed PCPs were selected via a combination of random and purposive selection from the PCP directory. RESULTS: Of 172 PCPs, 117 (68%) completed the online survey and 28 completed semistructured interviews. Most PCPs (77%) reviewed PRO responses with their patients. PCPs endorsed that PROs improve clinic efficiency and clinical management. However, PCPs have heterogeneous perspectives on the relevance of PROs in clinical practice, likely due to variations in clinic practice. For specific PRO instruments, PCPs reported anxiety and depression screening PROs to be most helpful. PCPs felt that PROs assisted with completing screening questions that are required by regulatory bodies. Barriers to using PROs include poor user-interface for both clinicians and patients and inadequate training. CONCLUSIONS: Most PCPs regularly use PRO data though there are mixed opinions about their clinical relevance. An adaptable, user-friendly PRO system has the potential to have meaningful clinical applications in primary care.

Predicting the 10-year risk of death from other causes in men with localized prostate cancer using patient-reported factors: Development of a tool.

OBJECTIVE: To develop a tool for estimating the 10-year risk of death from other causes in men with localized prostate cancer. SUBJECTS AND METHODS: We identified 2,425 patients from the Surveillance Epidemiology and End Results-Medicare Health Outcomes Survey database, age <80, newly diagnosed with clinical stage T1-T3a prostate cancer from 1/1/1998-12/31/2009, with follow-up through 2/28/2013. We developed a Fine and Gray competing-risks model for 10-year other cause mortality considering age, patient-reported comorbid medical conditions, component scores and items of the SF-36 Health Survey, activities of daily living, and sociodemographic characteristics. Model discrimination and calibration were compared to predictions from Social Security life table mortality risk estimates. RESULTS: Over a median follow-up of 7.7 years, 76 men died of prostate-specific causes and 465 died of other causes. The strongest predictors of 10-year other cause mortality risk included increasing age at diagnosis, higher approximated Charlson Comorbidity Index score, worse patient-reported general health (fair or poor vs. excellent-good), smoking at diagnosis, and marital status (all other vs. married) (all p<0.05). Model discrimination improved over Social Security life tables (c-index of 0.70 vs. 0.59, respectively). Predictions were more accurate than predictions from the Social Security life tables, which overestimated risk in our population. CONCLUSIONS: We provide a tool for estimating the 10-year risk of dying from other causes when making decisions about treating prostate cancer using pre-treatment patient-reported characteristics.

Lack of impact of paramedic training and use of the cincinnati prehospital stroke scale on stroke patient identification and on-scene time.

BACKGROUND AND PURPOSE: The Cincinnati Prehospital Stroke Scale (CPSS) is recommended for emergency medical services use in identifying patients with stroke. Data evaluating its performance in the field are limited. We assessed the impact of training and use of the CPSS on the accuracy of paramedics' stroke patient identification and on-scene time. METHODS: A 1-hour interactive educational presentation on the use of the CPSS was conducted for paramedics transporting patients to an academic medical center. Patients with stroke/transient ischemic attack (TIA) were identified retrospectively from paramedic records and were compared with the hospital's prospective stroke registry for the year before and after the training. RESULTS: There were 154 patients with suspected stroke/transient ischemic attack identified (56% women, 53% white, 44% black, mean age 67+/-16 years). There was no difference in paramedics' use of the CPSS (37.5% versus 23.8%, P=0.123) or accuracy of stroke/TIA patient identification (40.5% versus 38.9%, P=0.859) before and after training. Of responsive patients identified by paramedics as having a stroke/TIA, 57% had an abnormality in at least one CPSS item with no effect on on-scene time (17+/-6 minutes with a normal versus 18+/-6 minutes with an abnormal CPSS, P=0.492). Those with a final diagnosis of stroke/TIA (n=61, 40%) more frequently had at least one abnormal CPSS item (70% versus 30%, P=0.008, sensitivity 0.71, specificity 0.52) with 49% of patients with an abnormality having a discharge diagnosis of stroke/TIA. CONCLUSIONS: Paramedic training in the CPSS, or its use, had no impact on the accuracy of their identification of patients with stroke/TIA or on-scene time.

Overcoming barriers to developing seamless ST-segment elevation myocardial infarction care systems in the United States: recommendations from a comprehensive Prehospital 12-lead Electrocardiogram Working Group.

BACKGROUND: Reducing time to reperfusion treatment for patients with ST-segment elevation myocardial infarction (STEMI) improves patient outcomes. Few medical systems consistently meet current benchmarks regarding timely access to treatment. Studies have widely demonstrated that prehospital 12-lead electrocardiography can facilitate early catheterization laboratory activation and is the most effective means of decreasing patients' time to treatment. METHODS: We gathered experts to examine the barriers to implementation of prehospital 12-lead electrocardiographic monitoring and transmission to in-hospital cardiologists in creating seamless STEMI care systems (STEMI-CS) and propose multidisciplinary approaches to overcoming these barriers. RESULTS AND CONCLUSIONS: Physicians, hospital systems, and emergency medical services often lack coordination of care delivery and receive fragmented funding and oversight. Clinical and regulatory guidelines do not emphasize local solutions to achieving clinical benchmarks, do not target incentives at all components of the STEMI-CS, and underemphasize risk-based approaches to protecting patient health. Integration of the multiple complex components involved in STEMI-CS is essential to improving care delivery.

Impact of 2012 USPSTF Screening PSA Guideline Statement: Changes in Primary Care Provider Practice Patterns and Attitudes.

INTRODUCTION: Prostate specific antigen use in prostate cancer screening has undergone significant changes since the 2012 release of the USPSTF (United States Preventive Services Task Force) guideline statement. The effect on specific primary care provider practice patterns and attitudes is not well characterized. We describe the impact of the USPSTF statement on prostate cancer screening practices, attitudes and knowledge among primary care providers. METHODS: A survey composed of 25 questions was mailed electronically to approximately 350 primary care providers within a single academic health care system. Responses were recorded and could not be traced to the respondent. RESULTS: A total of 73 primary care providers (21%) responded to the survey. Of the respondents 75% reported a change in prostate specific antigen screening practices resulting from the USPSTF recommendations and 35% reported a decrease in digital rectal examination use, although the latter test is not explicitly addressed in the guideline statement. A third of respondents believe that prostate specific antigen screening has "likely had no role" in the 2-decade decline in prostate cancer mortality and 70% agree that prostate specific antigen screening may "impart more harm than good" to the patient. Despite these opinions, there was markedly greater concern for medicolegal consequences of a missed diagnosis compared to over diagnosis. CONCLUSIONS: The results of the survey, while limited to a single large academic center, show the impact of the USPSTF 2012 statement on physician attitudes and practice patterns. The results define the need for more educational opportunities for primary care providers regarding the USPSTF statement, American Urological Association guidelines and identification of patients appropriate for prostate specific antigen screening.

Quality of life in patients with benign nontoxic goiter: impact of disease and treatment response, and comparison with the general population.

BACKGROUND: While health-related quality of life (HRQoL) issues often prompt treatment of benign nontoxic goiter (NTG), few clinical studies have systematically assessed HRQoL in patients with this condition. The purpose of the present study was to evaluate thyroid-related and generic HRQoL in patients with benign NTG, as compared to the general population, before and six months after treatment. METHODS: Thyroid-related and generic HRQoL were assessed with Thyroid Patient-Reported Outcome (ThyPRO) and Medical Outcomes Study 36-item Short Form (SF-36), respectively. Baseline and six-month post-treatment HRQoL assessments were obtained from 111 patients with NTG who underwent radioiodine therapy (32%), hemithyroidectomy (53%), total thyroidectomy (12%), or cyst aspiration with ethanol sclerotherapy (4%). Euthyroid patients were enrolled at baseline, 80% of whom remained euthyroid six months post-treatment, with 20% experiencing subclinical thyroid dysfunction. Normative ThyPRO (n=739) and SF-36 (n=6638) data were collected from representative general population samples. Score differences between patients and the general population were analyzed with multivariate linear regression analysis, adjusting for age, sex, comorbidity, and educational status. Changes in scores between baseline and follow-up were analyzed with the paired t-test, and magnitudes of score changes were evaluated as effect sizes (mean difference/SDbaseline; 0.2-0.5 indicating small, 0.5-0.8 moderate, and >0.8 large effects). RESULTS: Patients' baseline scores were significantly worse than those in the general population on 9 of the 13 ThyPRO scales. Six months after treatment, the patients' ThyPRO scores had improved on six scales, with large/moderate effects on the Goiter Symptoms and Anxiety scales. However, on eight scales, the post-treatment patient scores were still significantly worse than the general population scores. At baseline, patients had worse scores than the general population on four of the eight SF-36 scales and the SF-36 Mental Component Summary, none of which improved after treatment. CONCLUSIONS: Compared with the general population, patients with NTG had greatest HRQoL impairment at baseline on the Goiter Symptoms and Anxiety scales, which also demonstrated the largest post-treatment improvements. However, both disease-specific and generic HRQoL deficits persisted six months after treatment. In order to improve individualized care, future studies should focus on identifying risk factors for persistent HRQoL deficits and compare HRQoL effects of the various goiter treatment modalities in relation to thyroid phenotype.

Assessing health-related quality of life in patients with benign non-toxic goitre.

Health-related quality of life (HRQoL) assessments are increasingly used to evaluate treatment effects and to shape the delivery of value based care. Valid generic and disease specific tools are available for quantifying HRQoL in patients with non-toxic goitre. However, few studies have applied these validated instruments to assess HRQoL in patients with benign non-toxic goitre. Limited evidence suggests that patients with non-toxic goitre have HRQoL impairments in multiple HRQoL domains. While the HRQoL-impact of non-toxic goitre may be small relative to other severely disabling medical conditions, treatment is almost exclusively elected for HRQoL indications. Thus better quantification of HRQoL, particularly at better (or more favorable) levels where many patients score, is essential. Web and mobile technologies have eased the ability to deliver surveys to patients. Routine consideration of HRQoL provides the opportunity to monitor the impact of treatment on the outcomes most meaningful for patients and the opportunity to help shape the delivery of value based health care.