Efficacy and safety of onabotulinumtoxinA for the treatment of overactive bladder in men and women: A pooled analysis.

BACKGROUND: This pooled analysis of randomized controlled studies investigated the safety and efficacy of onabotulinumtoxinA in male and female patients with overactive bladder (OAB). METHODS: Data were pooled from four similarly designed trials in North America and Europe. Adults with idiopathic OAB for ≥6 months inadequately managed by at least one anticholinergic were randomized 1:1 or 2:1 to receive onabotulinumtoxinA 100 U or matched placebo in Cycle 1 and could request open-label retreatment with onabotulinumtoxinA 100 U at ≥12 weeks. Efficacy outcomes at Week 12 included the primary endpoint of mean urinary incontinence (UI) episodes per day and other variables, such as the proportion of patients with ≥50% reduction in daily UI episodes. Safety was assessed by monitoring treatment-emergent adverse events (TEAEs). Analyses by sex were descriptive. Males were further analyzed by benign prostatic hyperplasia (BPH) diagnosis status. RESULTS: In the pooled population (N = 1564), there were 194 males (12.4%) and 1370 females (87.6%). Mean number of baseline UI episodes per day was 4.9 in males and 5.5 in females. At Week 12, numerically greater mean reductions from baseline in number of daily UI episodes were observed with the onabotulinumtoxinA 100 U group (females: -3.0; males: -2.2) versus placebo (females: -1.1; males: -1.3). Achievement of ≥50% reduction in daily UI episodes was numerically greater with onabotulinumtoxinA 100 U (females: 64.8%; males: 61.2%) versus placebo (females: 30.6%; males: 44.8%), and numerically higher in males without BPH (onabotulinumtoxinA: 65.1%; placebo: 50.9%) versus with BPH (onabotulinumtoxinA: 54.3%; placebo: 36.6%). A total of 34.7% of males and 39.4% of females experienced at least one TEAE in the first 12 weeks during treatment Cycle 1. Urinary tract infection rate was 13.1% in females and 4.2% in males; incidence of hematuria was 6.8% in males and 1.1% in females. Incidence of urinary retention (defined as incomplete emptying, requiring catheterization) was 2.7% in females and 4.7% in males. CONCLUSION: OnabotulinumtoxinA 100 U was efficacious and well tolerated in men and women with OAB, including in males with and without BPH. No new safety findings were identified when data were analyzed by sex.

Results of a study examining the use of onabotulinumtoxinA in pediatric patients with overactive bladder.

BACKGROUND: There is a lack of approved treatments for pediatric patients with overactive bladder (OAB) with inadequate response to anticholinergic therapy. OnabotulinumtoxinA 100U is approved to treat OAB in adults based on data from randomized, pivotal trials. OBJECTIVE: To investigate the efficacy and safety of onabotulinumtoxinA treatment of OAB in children aged 12-17 years who were not adequately managed with anticholinergics. STUDY DESIGN: In this multinational, multicenter, randomized, double-blind, parallel-group, multiple-dose study (NCT02097121), pediatric patients with OAB were randomized 1:1:1 to receive onabotulinumtoxinA 25U, 50U, or 100U (≤6 U/kg). Patients could request retreatment starting at week 12. The primary endpoint was change from baseline to week 12 after treatment 1 in daily frequency of daytime urinary incontinence (UI) episodes. Safety assessments evaluated treatment-emergent adverse events (TEAEs). RESULTS: Of 68 screened patients, 55 received ≥1 treatment. Mean age was 14 years; 85.5% of patients were female. At week 12 after treatment 1, least squares mean change from baseline in daily frequency of daytime UI episodes showed a numerically greater reduction in the 100U arm (-2.4) versus the 25U arm (-1.4; P = 0.38), with a significant within-group change from baseline in the 100U arm (P = 0.0027). Achievement of treatment response was significantly greater with onabotulinumtoxinA 100U vs 25U (Figure). Median time to request retreatment was ≥16 weeks in all groups. The most frequently reported TEAEs were nasopharyngitis (10.9%) and urinary tract infection (UTI; 10.9%). Urinary retention was observed in 1 patient during treatment cycle 2; there were no serious TEAEs of UTI or urinary retention. Throughout 2 additional treatment cycles continued efficacy for the 100U dose arm was observed along with a consistent safety profile. DISCUSSION: Change in daily frequency of UI episodes at week 12 in treatment cycle 1 was not significantly different between arms. However, ≥50% response rate was significantly higher with onabotulinumtoxinA 100U versus 25U. Enrollment challenges that lowered the sample size could have reduced statistical power. Also, the lack of a placebo arm and the observed benefit with the 25U comparator limited interpretation. CONCLUSIONS: OnabotulinumtoxinA injections were well tolerated in children with OAB at all doses studied. Although the primary endpoint was not met, the significantly greater treatment response rate observed with onabotulinumtoxinA 100U versus 25U suggests additional benefit of the higher dose, without additional safety concerns.

User Manual for Coping Strategies Inventory Short Form (CSI-SF)-The Jackson Heart Study.

Researchers have asserted that patients who generally rely on powerful external sources to control their disorders can benefit from examining their coping mechanisms, which can potentially lead to a better understanding of the initiation and progression of some chronic diseases. By trusting their own internal powers and virtues, it is possible for some people to discover and navigate available strategies to balance and enhance their psycho-spiritual well-being and possibly their treatment and recovery. This review serves as a user manual for investigators who choose to use the CSI-SF to conduct their research on coping behaviors. The CSI-SF, which measures four coping strategies based on 16 items, was first assessed using the Jackson Heart Study (JHS) cohort in 2007. The reliability and construct validity of the CSI-SF was also later assessed among hemodialysis patients across 13 countries. In this study, the CSI-SF was assessed to be a reliable and valid instrument for measuring coping strategies. The CSI-SF serves the purpose of developing an inner voice that can assist with understanding how people cope with everyday life. The information gathered from the administration of the CSI-SF can inform investigators about environmental cues and triggers that can also impact individual health.

Mortality Trends in Alzheimer's Disease in Mississippi, 2011-2021.

Alzheimer's disease is the sixth most common cause of death in the United States (U.S.), with one in three adults 65 years of age and older dying of the disease each year. Deaths from Alzheimer's have more than doubled between 2000 and 2019, killing more adults than both breast cancer and prostate cancer. In 2021, Alzheimer's disease resulted in 36 deaths per 100,000 in the U.S. In Mississippi, deaths from Alzheimer's have almost doubled between 2011 and 2021, resulting in 52.9 deaths per 100,000. Women have a higher mortality rate from Alzheimer's than men. Alzheimer's is a progressive disease that develops through seven stages. There are effective strategies to prevent the onset of Alzheimer's. METHODS: This paper reviews the risk factors, mortality trends, etiology, and prognosis of Alzheimer's in Mississippi with a focus on prevention. RESULTS: The southern diet with foods high in sugar and sodium, along with sedentary and poor lifestyle choices, increases mortality risk from Alzheimer's disease for women in Mississippi, specifically due to women over 65 having higher rates of obesity and hypertension. CONCLUSION: Understanding the epidemiology and risk factors of Alzheimer's in Mississippi will help inform communities, policies, and programs to prevent disease occurrence.

Treatment of neurogenic detrusor overactivity and overactive bladder with Botox (onabotulinumtoxinA): Development, insights, and impact.

Neurogenic detrusor overactivity (NDO) is a complication of multiple sclerosis, spinal cord injury (SCI), stroke, head injury, and other conditions characterized by damage to the upper motor neuronal system. NDO often leads to high bladder pressure that may cause upper urinary tract damage and urinary incontinence (UI). Prior to the use of onabotulinumtoxinA, oral anticholinergics and surgical augmentation cystoplasty were the treatment options. Overactive bladder (OAB) is non-neurogenic and affects a much larger population than NDO. Both NDO and OAB negatively impact patients' quality of life (QOL) and confer high health care utilization burdens. Early positive results from pioneering investigators who injected onabotulinumtoxinA into the detrusor of patients with SCI caught the interest of Allergan, which then initiated collaborative clinical trials that resulted in FDA approval of onabotulinumtoxinA 200U in 2011 for NDO and 100U in 2013 for patients with OAB who inadequately respond to or are intolerant of an anticholinergic. These randomized, double-blind, placebo-controlled trials for NDO showed significant improvements in UI episodes, urodynamic parameters, and QOL; the most frequent adverse events were urinary tract infection (UTI) and urinary retention. Similarly, randomized, double-blind, placebo-controlled trials of onabotulinumtoxinA 100U for OAB found significant improvements in UI episodes, treatment benefit, and QOL; UTI and dysuria were the most common adverse events. Long-term studies in NDO and OAB showed sustained effectiveness and safety with repeat injections of onabotulinumtoxinA, the use of which has profoundly improved the QOL of patients failing anticholinergic therapy and has expanded the utilization of onabotulinumtoxinA into smooth muscle.

Long-term Safety and Tolerability of Repeated Treatments With OnabotulinumtoxinA in Children With Neurogenic Detrusor Overactivity.

PURPOSE: OnabotulinumtoxinA is an approved treatment for neurogenic detrusor overactivity in adults inadequately managed with anticholinergics, and more recently was approved in children on the basis of a phase 3, 48-week, single-treatment study (NCT01852045). Given the paucity of long-term pediatric data, we report on the continued safety in these patients after repeated onabotulinumtoxinA treatment. MATERIALS AND METHODS: This was a multicenter, double-blind, repeat-treatment extension study (NCT01852058) in patients who entered from the preceding single-treatment study. Data were integrated across both studies. All patients (5-17 years) used clean intermittent catheterization and could receive dose escalations based on response to preceding treatment (50 U, 100 U, or 200 U onabotulinumtoxinA [not to exceed 6 U/kg]). RESULTS: Overall, 95, 90, 55, and 11 patients received 1, 2, 3, and 4 treatments with onabotulinumtoxinA, respectively, and median (quartiles) duration of follow-up was 82 (65, 94) weeks. The safety profile was similar across doses and after repeat treatments. The most common treatment-emergent adverse event during cycles 1, 2, and 3 was urinary tract infection (31%, 34%, 22%). Three serious treatment-emergent adverse events related to study treatment (3/95; 3.2%) were reported during the study, which were all cases of urinary tract infection. Annualized urinary tract infection rates post-treatment were similar to pre-screening rates. There were no cases of autonomic dysreflexia, neutralizing antibodies, and treatment-emergent adverse events related to distant spread of toxin. CONCLUSIONS: OnabotulinumtoxinA continued to be well tolerated after repeated treatments in pediatric neurogenic detrusor overactivity patients with similar safety profiles across dose groups. Treatment-emergent adverse events were primarily urological with no new safety concerns.

Trust and Biomedical Research Engagement of Minority and Under-Represented Communities in Mississippi, USA.

Trust is critical to the development and maintenance of effective research collaborations and community engagement. The purpose of this study was to assess the current attitudes and level of trust pertaining to health research among residents of Central Mississippi, the priority health region for the Research Centers in Minority Institutions (RCMI) Center for Health Disparities Research (RCHDR) at Jackson State University. The cross-sectional study was conducted from November 2021 to April 2022. The data were analyzed using descriptive statistics carried out by SPSS statistical software. A total of 146 participants responded to the survey. The participants were predominately African American (99%) and female (75%). Historical research studies, the researchers' qualities, and potential benefits from participation were factors affecting the level of trust in the research process. Ninety percent (n = 131) expressed that it was important to be involved in the research process, and 98.5% (n = 144) agreed that discussing the research findings with the participants was important for establishing trust in the research process. While trust in the research process does not guarantee participation, trust is a precursor for those who decide to engage in health disparities research. Key findings will be integrated into the RCHDR research agenda to foster further development and implementation of innovative community-based participatory research toward the control and/or prevention of diseases that disproportionately affect minority and under-represented populations in Mississippi.

Evaluating Levels of Community Participation in a University-Community Partnership: The Jackson Heart Study.

OBJECTIVE: This research was designed to evaluate the perceptions of the Jackson Heart Study (JHS) community relating to their levels of involvement in JHS activities that were developed to address health disparities and promote health education and health promotion. METHODS: The participants for this study comprised 128 community members, who included JHS participants, as well as family members and other friends of the JHS who resided in the JHS community of Hinds, Madison, and Rankin Counties in Mississippi and attended the JHS Annual Celebration of Life. We used the Chi-Square test to analyze the participants' responses to the survey questions developed to address the six areas of focus: (1) ways to increase participation in community outreach activities; (2) reasons for participating in community outreach activities; (3) interest in research participation; (4) factors influencing engagement; (5) Participants' preferences for communicating; (6) Chronic disease prevalence. RESULTS: Participants residing in rural counties perceived television and radio as a medium to increase participation; More female respondents cited trust working with the JSU JHS Community Outreach Center (CORC) as a reason for remaining engaged in the community outreach activities; younger participants under 66 years of age recommended social media as a way to increase participation; participants residing in the rural areas saw their participation in the community outreach activities as a way to address community health problems. CONCLUSIONS: The knowledge gained from the details provided by the JHS community members can be used to refine research studies in existence, while promoting their sustainability.

Feasibility of a Self-Measured Blood Pressure Monitoring Program to Reduce Uncontrolled Hypertension.

BACKGROUND: Hypertension is a common, serious condition affecting about one-third of adults in the United States. Self-measured blood pressure (SMBP) monitoring, combined with clinical support, is recommended to improve hypertension control and patient outcomes. METHODS: We conducted a retrospective analysis of a SMBP monitoring program that supported recruited patients in using wireless Bluetooth monitors to track their blood pressure at home and gave outpatient practices real-time access to patients' measurements. We analyzed SMBP measurements, practice-user log data, and patient and practice experience evaluations. RESULTS: Project staff recruited 17 outpatient practices and 187 patients. After four weeks, 64% of participants consistently monitored their blood pressure at least three times per week. A majority of patients (79%) reported an increased ability to manage their hypertension. In total, clinicians received 1,849 alerts and documented 409 actions. CONCLUSIONS: This analysis demonstrates the feasibility of combining SMBP with real-time access to home measurements by outpatient practices.

Rare genetic variants explain missing heritability in smoking.

Common genetic variants explain less variation in complex phenotypes than inferred from family-based studies, and there is a debate on the source of this 'missing heritability'. We investigated the contribution of rare genetic variants to tobacco use with whole-genome sequences from up to 26,257 unrelated individuals of European ancestries and 11,743 individuals of African ancestries. Across four smoking traits, single-nucleotide-polymorphism-based heritability ([Formula: see text]) was estimated from 0.13 to 0.28 (s.e., 0.10-0.13) in European ancestries, with 35-74% of it attributable to rare variants with minor allele frequencies between 0.01% and 1%. These heritability estimates are 1.5-4 times higher than past estimates based on common variants alone and accounted for 60% to 100% of our pedigree-based estimates of narrow-sense heritability ([Formula: see text], 0.18-0.34). In the African ancestry samples, [Formula: see text] was estimated from 0.03 to 0.33 (s.e., 0.09-0.14) across the four smoking traits. These results suggest that rare variants are important contributors to the heritability of smoking.

Intravesical Instillation of OnabotulinumtoxinA in the Treatment of Refractory Overactive Bladder in Participants with Urinary Incontinence.

PURPOSE: Intradetrusor injections of onabotulinumtoxinA are efficacious for the treatment of overactive bladder with urgency urinary incontinence in adults refractory to or intolerant of anticholinergics. Delivery of onabotulinumtoxinA via instillation would reduce the need for intradetrusor injections. The objective of this trial was to assess the efficacy and safety of intravesical instillation of an onabotulinumtoxinA + hydrogel admixture. MATERIALS AND METHODS: After review of a stage 1 safety phase by an independent committee, participants were recruited into stage 2 and randomized to either onabotulinumtoxinA 100, 300, 400, or 500 U, or placebo, all with hydrogel admixture. End points included change from baseline to week 12 in the number of urinary incontinence episodes (primary); micturition, urgency urinary, and nocturia episodes/day; volume voided per micturition; proportion of participants with a ≥50% decrease from baseline in urinary incontinence episodes/day; and Overactive Bladder Questionnaire total score. Adverse events were reported. RESULTS: Change from baseline to week 12 in number of urinary incontinence episodes was -2.72 with placebo and ranged from -0.89 to -1.85 in the onabotulinumtoxinA + hydrogel treatment groups. No difference from placebo was observed for any efficacy end point. The proportions of participants with treatment-emergent adverse events were similar among all groups, with asymptomatic bacteriuria the highest reported (6.7%-15.5%). There were no reports of urinary retention or elevated post-void residual volume. CONCLUSIONS: Intravesical instillation of an onabotulinumtoxinA + hydrogel admixture for the treatment of refractory overactive bladder was well tolerated, but it showed no improvement over placebo.

Innovative Use of a Mobile Web Application to Remotely Monitor Nonhospitalized Patients with COVID-19.

Introduction: Most patients with COVID-19 do not require hospitalization but may need close monitoring, which can strain primary care practices. Our objective was to describe the implementation of a mobile web application to monitor COVID-19 signs and symptoms among nonhospitalized primary care patients and to assess the feasibility and acceptability of the application. Study Design: Retrospective analysis of (1) mobile web application data from March through December 2020 and (2) cross-sectional surveys administered in June 2020. Materials and Methods: We enrolled nonhospitalized patients and staff from nine New England primary care practices across 29 sites. Outcomes included feasibility and acceptability of the application as measured by the proportion of texts that resulted in a response, proportion of patients who agreed using the application was easy, and proportion of practice staff who agreed the application reduced outreach burden and that they would recommend use. Results: Five thousand five hundred thirty-two patients used the mobile web application, with 26,466 total responses. Overall, 78% of the daily texts resulted in a response from patients. Most patients agreed that responding to texts was easy (95%) and that they would be willing to participate in other texting programs (78%). Most staff agreed that the program reduced burden of outreach (94%) and that they would recommend use to other practices (100%). Conclusions: Use of a COVID-19 symptom tracking application was feasible and acceptable to patients and primary care practice staff. Outpatient practices should consider use of mobile web applications to monitor nonhospitalized patients with other acute illnesses.

Twenty Years of Leading the Way among Cohort Studies in Community-Driven Outreach and Engagement: Jackson State University/Jackson Heart Study.

BACKGROUND: History has recorded the tremendous concerns and apprehension expressed by African Americans about participating in research studies. This review enumerates the collaborative techniques that were utilized by the Jackson State University (JSU) Jackson Heart Study (JHS) community-focused team to facilitate recruitment and retention of the JHS cohort and to implement health education and health promotion in the JHS communities. METHODS: This review describes the evolution of the JSU JHS community initiatives, an innovative community-driven operation, during the period 1999-2018. RESULTS: JSU JHS community-focused investigators published approximately 20 manuscripts, including community-led research and publications with community lead authors and co-authors, research and publications in collaboration with other JHS staff, through other JSU-funded projects. The JSU JHS community-focused unit also initiated the JHS Community Training Activities, developed the Community Health Advisory Network (CHAN), and trained and certified 137 Community Health Advisors. In addition, the JSU JHS community-focused unit developed the Collaborative Community Science Model (CCSM) that symbolized its approach to community engagement and outreach, and a Trust Scale for ascertaining African Americans' willingness to engage in biomedical research collaborations. CONCLUSION: This review offers educators, public health professionals, and research investigators a useful starting point for the development, selection, or improvement of techniques to motivate, inspire, and engage community residents in a community-academia partnership that yielded maximum benefits in the areas of health education, health promotion and interventions, and biomedical research. Substantial, meaningful community engagement is possible when prioritizing elimination of health disparities and long-term improvement in health care access in the target populations.

OnabotulinumtoxinA for the treatment of neurogenic detrusor overactivity in children.

AIMS: This study evaluated whether one (or more) of three doses of onabotulinumtoxinA were safe and effective to treat neurogenic detrusor overactivity (NDO) in children. METHODS: This was a 48-week prospective, multicenter, randomized, double-blind study in children (aged 5-17 years) with NDO and urinary incontinence (UI) receiving one onabotulinumtoxinA treatment (50, 100, or 200 U; not to exceed 6 U/kg). Primary endpoint: change from baseline in daytime UI episodes. Secondary endpoints: change from baseline in urine volume at first morning catheterization, urodynamic measures, and positive response on the treatment benefit scale. Safety was also assessed. RESULTS: There was a similar reduction in urinary incontinence from baseline to Week 6 for all doses (-1.3 episodes/day). Most patients reported positive responses on the treatment benefit scale (75.0%-80.5%). From baseline to Week 6, increases were observed in urine volume at first morning clean intermittent catheterization (50 U, 21.9 ml; 100 U, 34.9 ml; 200 U, 87.5 ml; p = 0.0055, 200 U vs. 50 U) and in maximum cystometric capacity (range 48.6-63.6 ml) and decreases in maximum detrusor pressure during the storage phase (50 U, -12.9; 100 U, -20.1; 200 U, -27.3 cmH2 O; p = 0.0157, 200 U vs. 50 U). The proportion of patients experiencing involuntary detrusor contractions dropped from baseline (50 U, 94.4%; 100 U, 88.1%; 200 U, 92.6%) to Week 6 (50 U, 61.8%; 100 U, 44.7%; 200 U, 46.4%). Safety was similar across doses; urinary tract infection was most frequent. CONCLUSIONS: OnabotulinumtoxinA was well tolerated and effective for the treatment of NDO in children; 200 U showed greater efficacy in reducing bladder pressure and increasing bladder capacity.

Operational and Management Structure of the Jackson Heart Study Community Outreach Center.

The authors identified the key characteristics of the Jackson Heart Study Community Outreach Center as it worked to embed a sustainable, positive impact on the surrounding communities by engaging community partners to facilitate the mission of the Jackson Heart Study. This report provides an overview of the practice and infrastructure.

Association Between Sleep and Obesity in African Americans in the Jackson Heart Study.

BACKGROUND: In the United States, data from the National Health and Nutrition Examination Survey suggest that 68% of adults are overweight and obese. Obesity has been shown in previous cross-sectional and longitudinal studies to be influenced by short sleep duration, which can lead to unregulated appetite, excessive eating during awake time, and decreased energy expenditure. OBJECTIVE: To examine the associations among sleep duration, sleep quality, body mass index (BMI), and waist circumference (WC) in African Americans. METHODS: The sample included participants in the Jackson Heart Study. During a clinic visit, the sleep habits of participants were recorded via a sleep history questionnaire, and BMI and WC measurements were also recorded. Multivariate analysis was used to examine the associations among sleep duration, sleep quality, general obesity (measured by BMI), and abdominal obesity (measured by WC). RESULTS: The authors studied participants who provided data for the variables of interest (N=3778; 1363 men and 2415 women). Of all participants, 3317 (87.8%) were overweight, and 2149 (56.9%) were obese. The mean (SD) BMI was 32.1 (7.2) kg/m2, and the mean (SD) WC was 103.3 (16.0) cm. Mean sleep duration was 6.3 (1.4) hours for men and 6.4 (1.5) hours for women. Among the men, a significant negative relationship was found between sleep duration and body composition: longer sleep was associated with lower BMI levels but negatively associated with WC in men (ß=-1.06; P<.01)]. Sleep quality was positively associated with WC in men (ß=1.20; P<.01) and women (ß=0.61; P<.05). CONCLUSIONS: This study's findings highlight the high rate of overweight and obesity among participants in the Jackson Heart Study. About one-fourth of the participants described themselves as enjoying ideal health. In men, longer sleep duration was associated with lower BMI levels and lower WC; in both men and women, good sleep quality was associated with lower WC. However, more research is needed to examine sleep and body composition as risk factors for disease development in African Americans.

A Korean Postmarketing Study Assessing the Effectiveness of OnabotulinumtoxinA for the Treatment of Neurogenic Detrusor Overactivity or Idiopathic Overactive Bladder Using a Validated Patient-Reported Outcome Measure.

PURPOSE: OnabotulinumtoxinA has demonstrated efficacy and safety in the treatment of urinary incontinence (UI) associated with neurogenic detrusor overactivity (NDO) and idiopathic overactive bladder (OAB); however, real-world evidence is limited. This postmarketing surveillance study aimed to assess the effectiveness and safety of onabotulinumtoxinA in Korean patients with UI associated with NDO or OAB with an inadequate response or intolerance to anticholinergics. METHODS: Patients received 200 U (NDO) or 100 U (OAB) of onabotulinumtoxinA. Effectiveness (assessed using the validated International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]) and safety were assessed for 1-4 months after onabotulinumtoxinA administration. RESULTS: Overall, 686 patients (NDO, 161; OAB, 525) comprised the safety population; of these, 612 patients were analyzed for effectiveness. There was a significant decrease (P<0.0001) in the mean (standard deviation) ICIQ-SF scores in the NDO (-6.8±5.5) and OAB (-6.0±6.4) groups after onabotulinumtoxinA administration. A decrease of >5 points from baseline in the ICIQ-SF score was observed in 64.9% and 47.3% of patients in the NDO and OAB groups, respectively. Following treatment, 59.9% in the NDO group and 43.0% in the OAB group were dry. There was no effect of age on effectiveness in either group. Only 10 adverse drug reactions (ADRs) were reported in 5.6% of NDO patients and 20 ADRs in 3.2% of OAB patients. Most ADRs in both groups were related to the lower urinary tract such as dysuria (NDO, 1.2%; OAB, 0.6%) and urinary retention (NDO, 0.6%; OAB, 1.5%). CONCLUSION: Effectiveness and safety of onabotulinumtoxinA in Korea in a real-world setting was demonstrated.

An Innovative Simulation-based Community-engaged Intervention for Training Research Assistants in Culturally Appropriate Informed Consent.

BACKGROUND: Enrolling under-represented groups in biomedical research remains challenging owing to limited health literacy, historic medical abuses, and mistrust. Addressing such barriers requires scrutiny of informed consent processes and training of research assistants (RAs). Applying simulation methods that are well-established in medical education, Simulation-based Community-engaged Research Intervention for Informed Consent Protocol Testing and Training (SCRIIPTT) engages community members as community advisors (CAs) to train RAs in implementing culturally appropriate approaches, such as addressing difficult issues related to race and power dynamics, into the informed consent training process. OBJECTIVES: To present SCRIIPTT's development, implementation, and preliminary findings. METHODS: Over 12 months, our community-academic partnership 1) introduced SCRIIPTT to the greater community using the Truth & Reconciliation Model, which acknowledges the wrongs of research and offers an apology; 2) deepened understanding of community concerns; 3) developed the intervention; 4) conducted a pilot; and 5) disseminated findings. RESULTS: SCRIIPTT included a comprehensive training manual, scenarios for simulated informed consent encounters, and a 37-item checklist to measure performance. Outcomes include CA and RA satisfaction surveys, and RA performance rating. The checklist adequately measured observable behaviors. RAs reported important gains in knowledge, self-confidence, and cultural competence in conducting informed consent. CAs reported positive experiences, being fully engaged and valued as members of the research team and participants during simulation encounters. CONCLUSIONS: This pilot study demonstrated the feasibility of SCRIIPTT, with preliminary evidence of effectiveness and acceptability. SCRIIPTT offers an innovative approach for community engagement in research training and advancing the skills of RAs in culturally appropriate informed consent.