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This paper uses a recently completed study to illustrate how adaptive trial designs can increase efficiency of psychiatric drug development. The design employed allowed a continuous reassessment of the estimated dose-response such that patients were randomized in a double-blind fashion to one of seven doses of the investigational drug, placebo, or active comparator. The study design also permitted early detection of futility allowing for early study termination. By using the adaptive trial design approach, only 202 patients were needed to make the determination of futility. In contrast, a conventional design would have required enrollment of 450 patients and considerably more time and expense to reach the same conclusion. Adaptive trial designs are important at this time when many pharmaceutical companies are abandoning the development of psychiatric medications because of the inefficiency of conventional approaches. [ABSTRACT FROM AUTHOR]

Objectives: Cannabis legalization has increased its use. The incidence of acute pancreatitis (AP) and severe acute pancreatitis (SAP) has also increased. In this study, data on pancreatitis were obtained from 2 states before and after cannabis legalization and compared with 2 states without legalized cannabis., Methods: Data were extracted from State Inpatient Databases from the states of Colorado and Washington before recreational cannabis legalization (2011) and after legalization (2015). Arizona and Florida were used as the nonlegalized cannabis states. Multivariable logistic regression models were fit for AP and SAP to determine a trend difference between legalized and nonlegalized cannabis states., Results: Cannabis use, AP, and SAP increased in all states. The increase in AP and SAP was not significantly different between the states that legalized cannabis use and those that did not. Legalized cannabis states had lower charges for AP and SAP and shorter length of hospitalizations., Conclusions: The trend of AP and SAP increased during the study period, but this was not correlated to cannabis use. Cannabis users had lower hospitalization costs and hospital stay. The effects of other confounders such as cannabis dose and delivery methods, alcohol, tobacco, and others need to be studied further as use increases., Competing Interests: The other authors declare no conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: To evaluate whether patients with persistent muscle-invasive bladder cancer (MIBC) after undergoing neoadjuvant chemotherapy (NAC) and radical cystectomy (RC) have worse overall survival (OS) and cancer-specific survival (CSS) than patients with similar pathology who undergo RC alone., Materials and Methods: Using the Surveillance, Epidemiology and End Results (SEER)-Medicare database, we identified the records of patients with pT2-4N0M0 disease who underwent RC, with and without NAC, for MIBC between 2004 and 2011. To evaluate survival outcomes in those with MIBC after NAC vs patients with MIBC who underwent RC alone, we used Kaplan-Meier time-to-event analysis and Cox proportional hazard regression modelling. Landmark analysis was conducted to mitigate immortal time bias. Propensity scoring was used to decrease the risk of selection bias., Results: Of the 1 886 patients with persistent pT2-4 disease at the time of RC, 1505 underwent RC alone and 381 received NAC + RC. After adjusting for confounders, the propensity-weighted risk of death from bladder cancer after diagnosis did not differ between the groups (hazard ratio [HR] 0.72, 95% confidence interval [CI] 0.72-1.08; P = 0.23); however, the risk of death from all causes was worse in the RC-alone group (HR 0.79, 95% CI0.67-0.94; P = 0.006)., Conclusions: Patients who had persistent MIBC after platinum-based NAC + RC vs RC alone derived an OS benefit but not a CSS benefit from NAC. This may represent a selection bias favouring patients who were selected for NAC; however, the OS benefit was not evident in patients with persistent pT3-T4N0M0 disease. This study underscores the importance of future research investigating methods to identify patients who will respond to NAC for bladder cancer. It also highlights the need to consider adjuvant therapy in patients who have persistent MIBC after NAC., (© 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.)

Purpose: To characterize anterior urinary fistulae following radiotherapy for prostate cancer., Methods: Over 10 years, 31 men were identified to have an anterior urinary fistula. A retrospective database was created to evaluate patient demographics, presentation, diagnostic procedures, operative interventions, outcomes, and complications. Comparisons between men who underwent cystectomy versus bladder-sparing surgeries were performed., Results: At a median age of 73 (interquartile range (IQR) 68.5, 79) years, presenting symptoms included as follows: pubic pain (19/31, 61%), urine drainage via fistula (10/31, 32%), or a superficial wound infection (6/31, 19%). Recent instrumentation prior to diagnosis of anterior urinary fistula was reported by 18/31 (58%) at a median of 14.9 months (IQR 7.9, 103.8) after manipulation. Anterior fistula formation was either isolated to the pubic symphysis (19/31, 61%) or the thigh (12/31, 38%). Nineteen men underwent a cystectomy, whereas 12 men underwent a fistula repair. Excluding grades 1 and 2, 30- and 90-day postoperative complications were limited to four and two men, respectively, all of whom had a grade 3 complication. At 6-month follow-up, 26/31 (84%) men reported their pain had resolved. There was one fistula recurrence managed with subsequent cystectomy., Conclusions: Complex anterior urinary fistulae to the pubic symphysis and thigh are devastating yet treatable conditions. Universally, these men have a history of radiotherapy and repeated endoscopic interventions. Surgical intervention with either cystectomy or primary repair was highly successful.

Purpose: Active surveillance protocols track low risk prostate cancer progression over time. However, given the lack of uniform criteria for managing low risk prostate cancer, men who qualify for active surveillance might have less intensive surveillance and, thus, experience poorer outcomes. In this study we examined racial disparities in the frequency and intensity of active surveillance between African-American and Caucasian men., Materials and Methods: Using the linked SEER-Medicare data set we identified 13,374 men with low risk prostate cancer (defined by the D'Amico criteria) diagnosed from 2004 to 2009 and then followed through 2011. A total of 2,916 men did not receive any treatment (radiation, hormonal therapy or surgery) within 1 year after diagnosis. Men were considered to be on active surveillance if they had at least 1 of the following 3 surveillance strategies within 2 years after diagnosis, namely 1 or more prostate biopsies, 4 or more prostate specific antigen tests, and/or 4 or more visits to the doctor with prostate cancer listed as the diagnosis. To compare the frequency of active surveillance between the groups (African-American vs Caucasian) we used the chi-square test. To estimate the odds ratio of active surveillance we used multivariable logistic regression after adjusting for possible confounders such as year of diagnosis, age at diagnosis, socioeconomic status and Charlson score., Results: Of the 2,916 untreated men 1,141 (39%), including 963 (37%) Caucasian men and 178 (58%) African-American men (p <0.0001), did not undergo any of the 3 surveillance strategies but instead were essentially on watchful waiting. Caucasian men (vs African-American) were more likely to be on active surveillance, with 1,646 (63.1%) vs 129 (42.0%) opting for 1 surveillance strategy (p <0.0001), 783 (30.0%) vs 50 (16.3%) opting for any 2 strategies (p <0.0001) and 193 (7.4%) vs 11 (3.6%) going through all 3 (p=0.01). On multivariable analysis African-American men had significantly lower odds of being on active surveillance than Caucasian men (OR 0.52, 95% CI 0.40-0.67). Men with more comorbidities (Charlson score 1 or greater) had significantly higher odds of being placed on active surveillance than watchful waiting (OR 1.7, 95% CI 1.46-2.12)., Conclusions: Among those not treated for low risk prostate cancer, Caucasian men were placed on active surveillance more frequently than African-American men, who often defaulted to de facto watchful waiting after an initial period of active surveillance. This discrepancy raises questions about the factors favoring watchful waiting over active surveillance. Moreover, given the lack of consensus regarding the most efficient active surveillance strategy, we anticipate that racial disparities in the use of active surveillance will persist, especially in African-American patients., (Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Context: National databases can be used to investigate diabetes prevalence and health care use. Guideline-based care can reduce diabetes complications and morbidity. Yet little is known about the prevalence of diabetes and compliance with diabetes care guidelines among rural residents and whether different national databases provide similar results., Purpose: To examine rural-urban differences in the prevalence of diabetes and compliance with guidelines, and to compare the Behavioral Risk Factor Surveillance System (BRFSS) and the Medical Expenditures Panel Survey (MEPS)., Methods: Data for 2001-2002 were analyzed and compared by rural-urban status. Prevalence was calculated as simple unadjusted, weighted unadjusted, and weighted adjusted using a multivariate approach. Results from the 2 databases were compared., Findings: A slightly higher prevalence of diabetes among rural residents, 7.9% versus 6.0% in MEPS and 7.6% versus 6.6% in BRFSS, was found and persisted after adjustment for age, BMI, insurance coverage, and other demographic characteristics (adjusted OR 1.16 [1.02-1.31] in MEPS; 1.19 [1.01-1.20] in BRFSS). Rural persons in MEPS were less likely to receive an annual eye examination (aOR = 0.85) and a feet check (aOR = 0.89). A significantly (P < .05) smaller proportion of rural residents in BRFSS received an annual eye examination (aOR = 0.88), feet check (aOR = 0.85), or diabetes education (aOR = 0.83). Rural residents in both datasets were more likely to get a quarterly HbA1c test done., Conclusion: Rural residents in both datasets had higher prevalence of diabetes. Though not always statistically significant, the trend was to less guideline compliance in rural areas.

Background: Listeria monocytogenes is among the most virulent foodborne pathogens, with 20% of clinical infections resulting in death. To explore listeriosis-associated mortality in the United States and to evaluate prevention efforts, we reviewed vital records over a 16-year period to assess demographic, temporal, and seasonal trends., Methods: Nonperinatal listeriosis-associated deaths from 1990 through 2005 were identified from multiple-cause-coded death records and were combined with US census data to calculate mortality rates. Poisson regression was used to model time trends, and logistic regression was used to identify comorbid conditions associated with listeriosis on the death record., Results: Of the 37,267,946 deaths occurring in the United States during the 16-year study period, 1178 included listeriosis on the death record. Listeriosis-related mortality rates decreased annually by 10.74% from 1990 through 1996 and by 4.26% from 1996 through 2005. Seasonal trends show a distinct peak in mortality from July through October. After adjustment for age, sex, and race/ethnicity, listeriosis was positively associated with human immunodeficiency virus (HIV) infection (odds ratio, 4.19; 95% confidence interval, 3.06-5.73), lymphoid and hematopoietic cancers (odds ratio, 5.27; 95% confidence interval, 4.47-6.22), and liver disease (odds ratio, 2.05; 95% confidence interval, 1.54-2.73) on the death record., Conclusions: Nonperinatal listeriosis-associated deaths in the United States have decreased, paralleling a decreasing trend in incidence. Strict monitoring of food manufacturing processes, as well as improved treatment for HIV infection, may have played influential roles in preventing human infections. Health care providers should be aware of seasonal listeriosis patterns, as well as conditions predisposing individuals to severe infection and death due to L. monocytogenes infection, to guide strategies for disease management and prevention.

Reducing risks and improving benefits to the patients are requirements health professionals are faced with in their daily work. Furthermore, cuts in health funds and the competition for budgets require to enhancing efficacy and efficiency of health services. For meeting both challenges, adequate information and knowledge is needed, which can be gathered from documentation systems such as Electronic Health Records or Personal Health Records (PHRs), but also by performing dedicated clinical studies such as randomized controlled trials (RCTs) or cohort studies. Based on a literature analysis, quality of, and benefits from, RCTs have been analyzed. The benefits from connecting public health and PHRs are discussed in some details.

Diabetes is a chronic disease that causes a great deal of morbidity and mortality and poor quality of life for millions of people. Continuing care and patient education help maintain a good control of the disease and prevent complications. Since current available resources are limited to providing such an education during clinic or physician visits only, alternative ways to educate people about diabetes need to be identified. In this article we discuss the implementation of an automated diabetes education call center, we define the evaluation procedures we adopted, we summarize general guidelines for the implementation of the entire system based on our experience, and we present preliminary results about the use of the call center. We believe our system is providing "active health" since we deliver educational messages to patients at regular intervals and at the time of their choice without waiting for their actions.

Historically, public health has been at the forefront of data processing applications but it is lagging behind other areas of health care in the application of advanced interconnected and mobile information technologies. Ready to use technologies are lacking not only for the management of emerging infections or bio-terrorism but also for the coordination of prevention and chronic care initiatives. Advanced information and knowledge management for community health should expedite the transfer of research evidence to practice and provide essential logistical support for action. We need to find ways to integrate new scientific knowledge into our environment in order to expedite the translation of research to practice.