COVID-19 Testing in African American Churches Using a Faith-Health- Academic Partnership.

Increasing access to COVID-19 testing in influential, accessible community settings is needed to address COVID-19 disparities among African Americans. We describe COVID-19 testing intervention approaches conducted in Kansas City, Missouri, African American churches via a faith-health-academic partnership. Trained faith leaders promoted COVID-19 testing with church and community members by implementing multilevel interventions using a tailored toolkit and standard education information. The local health department conducted more than 300 COVID-19 tests during or after Sunday church services and outreach ministry activities. (Am J Public Health. 2022;112(S9):S887-S891. https://doi.org/10.2105/AJPH.2022.306981).

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.

Importance: The US Food and Drug Administration (FDA) uses 510(k) clearance and premarket approval (PMA) pathways to ensure device safety before marketing. Premarket approval evaluates high-risk medical devices and requires clinical trials, whereas 510(k) clearance evaluates moderate-risk devices and relies on benchtop (nonclinical and biomechanical) and descriptive data. Existing literature suggests that the clinical trials required by PMA are associated with reduced risk of recall compared with devices granted 510(k) clearance. Several investigators have found weaknesses in pivotal PMA trials, raising safety concerns. Furthermore, methodological factors may have led to a previous underestimation of recall risk for devices with PMA. Objectives: To compare risk of recall and high-risk recall between devices that received 510(k) clearance and those that received PMA and to compare the risk of recall between devices for medical specialties. Design, Setting, and Participants: This cohort study compared devices with 510(k) clearance vs those with PMA that reached the market between January 1, 2008, and December 31, 2017. Two- to 12-year follow-up was obtained from the FDA's 510(k) and PMA medical device database. Orthopedic surgery was chosen arbitrarily as the reference category for analysis between specialties because no baseline exists. Statistical analysis was performed from February 1 to November 1, 2020. Main Outcomes and Measures: The FDA issues recalls for safety concerns. These recalls are stratified into class I, II, and III, with class I representing high-risk issues for serious harm or death. The main outcome was the hazard ratio of any recall and class I recall between devices with PMA and those with 510(k) clearance. The secondary outcome was the recall hazard ratio between specialties with respect to the reference category. A single Cox proportional hazards regression model evaluating the association of medical specialty and FDA approval pathway with the risk of recall was performed. Results: During the study period, 28 246 devices received 510(k) clearance and 310 devices (10.7%) received PMA; 3012 devices (10.7%) with 510(k) clearance and 84 devices (27.1%) with PMA were recalled. A total of 216 devices (0.8%) with 510(k) clearance and 16 devices (5.2%) with PMA had class I recalls. Devices with PMA compared with those with 510(k) clearance had a hazard ratio for recall of 2.74 (95% CI, 2.19-3.44; P < .001) and a hazard ratio for high-risk recall of 7.30 (95% CI, 4.39-12.13; P < .001). Only radiologic devices were associated with an increased risk of recall (hazard ratio, 1.57; 95% CI, 1.32-1.87; P < .001), whereas 6 specialties were assocated with a decreased risk compared with the orthopedic reference category: general and plastic surgery, otolaryngology, obstetrics and gynecology, physical medicine, hematology, and general hospital. Conclusions and Relevance: This study suggests that high-risk medical devices approved via PMA are associated with a greater risk of recall than previously reported. Most recalls are for devices with 510(k) clearance, also raising safety concerns. Strengthening postmarketing surveillance strategies and pivotal trials may improve device safety.

The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.

BACKGROUND: The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. METHODS: Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). RESULTS: Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. CONCLUSIONS: This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.

Implementation of a Quality Improvement Bundle Improves Echocardiographic Imaging after Congenital Heart Surgery in Children.

BACKGROUND: Postoperative echocardiography after congenital heart disease surgery is of prognostic importance, but variable image quality is problematic. We implemented a quality improvement bundle comprising of focused imaging protocols, procedural sedation, and sonographer education to improve the rate of optimal imaging (OI). METHODS: Predischarge echocardiograms were evaluated in 116 children (median age, 0.51 years; range, 0.01-5.6 years) from two centers after tetralogy of Fallot repair, arterial switch operation, and bidirectional Glenn and Fontan procedures. OI rates were compared between the centers before and after the implementation of a quality improvement bundle at center 1, with center 2 serving as the comparator. Echocardiographic images were independently scored by a single reader from each center, blinded to center and time period. For each echocardiographic variable, quality score was assigned as 0 (not imaged or suboptimally imaged) or 1 (optimally imaged); structures were classified as intra- or extracardiac. The rate of OI was calculated for each variable as the percentage of patients assigned a score of 1. RESULTS: Intracardiac structures had higher OI than extracardiac structures (81% vs 57%; adjusted odds ratio [OR], 3.47; P < .01). Center 1 improved overall OI from 48% to 73% (OR, 4.44; P < .01), intracardiac OI from 69% to 85% (OR, 3.53; P = .01), and extracardiac OI from 35% to 67% (OR, 5.16; P < .01). There was no temporal difference for center 2. CONCLUSIONS: After congenital heart disease surgery in children, intracardiac structures are imaged more optimally than extracardiac structures. Focused imaging protocols, patient sedation, and sonographer education can improve OI rates.

Evaluation of the Impact of Corticosteroid Dose on the Incidence of Hyperglycemia in Hospitalized Patients with an Acute Exacerbation of Chronic Obstructive Pulmonary Disease.

PURPOSE: Guidelines recommend systemic corticosteroids for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) albeit in lower doses than studies that cemented corticosteroids' place in therapy. Corticosteroids potentiate hyperglycemia, however it is undetermined how corticosteroid dose impacts hyperglycemia incidence. OBJECTIVES: To establish whether a greater incidence of steroid-induced hyperglycemia (SIHGLY) exists for high- versus low-dose corticosteroids. METHODS: Patients with primary discharge diagnosis 491.21/491.22 in a community hospital were retrospectively reviewed and divided into tertiles based on corticosteroid dosage. Baseline characteristics and primary endpoint were statistically assessed between tertiles using logistic regression analysis. A Cox proportional hazards (CPH) model adjusted for potential covariates. Post hoc analysis for primary outcome and CPH model was run removing non-insulin dependent diabetics because of disproportionate event count. A secondary endpoint used a Kaplan-Meier curve to evaluate time to event between tertiles. RESULTS: Tertile divisions were 125 and 187.5 mg methylprednisolone equivalents. The primary outcome for incidence of SIHGLY was insignificant; post hoc analysis removing non-insulin-dependent diabetics narrowly missed significance between tertiles 1 and 3 (P = .056). CPH analysis found significant differences in SIHGLY between tertiles 1 and 2 (hazard ratio [HR], 1.68; 95% CI, 1.02-2.76) and tertile 1 and 3 (HR, 1.79; 95% CI, 1.13-2.84), further post hoc analysis resulted in a loss of significance for the CPH analysis. Of 21 non-insulin-dependent diabetics, 20 met event status. The Kaplan-Meier analysis results were insignificant. CONCLUSIONS: Study results suggest that a link between larger corticosteroid doses and hyperglycemia incidence may exist, but it requires further study. RESULTS in non-insulin-dependent diabetics provide evidence for increased glucose monitoring upon initiation of corticosteroid therapy.

Impact of Variability in Echocardiographic Interpretation on Assessment of Adequacy of Repair Following Congenital Heart Surgery: A Pilot Study.

Technical Performance Score (TPS) is based largely on the presence and magnitude of residual lesions on postoperative echocardiograms; this score correlates with outcomes following repair of congenital heart defects. We evaluated reader variability for echocardiographic components of TPS for complete repair of tetralogy of Fallot (TOF) and arterial switch operation (ASO) in two centers and measured its effect on TPS. Postoperative echocardiograms were evaluated in 67 children (39 TOF and 28 ASO). Two readers (one per center) interpreted each echocardiogram. Reader variability in image quality assessments and measurements was compared using weighted kappa (κ), percent agreement, and intra-class correlation. TPS class (1 optimal-no residua, 2 adequate-minor residua, 3 inadequate-major residua) was assigned for each echocardiographic review by an independent investigator. The effect of reader interpretation variability on TPS classification was measured. There was strong agreement for TPS between the two readers (κ = 0.88). The readers were concordant for TPS classes for 57 children (85%) and discordant for classes 2 (minor residua) versus 3 (major residua) in six (9%). Coronary arteries and branch pulmonary arteries were frequently suboptimally visualized. Although inter-reader agreement for TPS was strong, inter-reader variation in echocardiographic interpretations had a small, but important effect on TPS for TOF and ASO, particularly for the distinction between minor and major residua. Further studies of generalizability and reproducibility of TPS and refinement of scoring modules may be needed before it can be used as a tool to assess pediatric cardiac surgical performance and outcomes.

Does active dissemination of evidence result in faster knowledge transfer than passive diffusion?: An analysis of trends of the management of pediatric asthma and croup in US emergency departments from 1995 to 2009.

OBJECTIVE: This study aimed to compare knowledge transfer (KT) in the emergency department (ED) management of pediatric asthma and croup by measuring trends in corticosteroid use for both conditions in EDs. METHODS: A retrospective, cross-sectional study of the National Hospital Ambulatory Medical Care Survey data between 1995 and 2009 of corticosteroid use at ED visits for asthma or croup was conducted. Odds ratios (OR) were calculated using logistic regression. Trends over time were compared using an interaction term between disease and year and were adjusted for all other covariates in the model. We included children aged 2 to 18 years with asthma who received albuterol and were triaged emergent/urgent. Children aged between 3 months to 6 years with croup were included. The main outcome measure was the administration of corticosteroids in the ED or as a prescription at the ED visit. RESULTS: The corticosteroid use in asthma visits increased from 44% to 67% and from 32% to 56% for croup. After adjusting for patient and hospital factors, this trend was significant both for asthma (OR, 1.07; 95% confidence interval [CI], 1.04-1.10) and croup (OR, 1.07; 95% CI, 1.03-1.12). There was no statistical difference between the 2 trends (P = 0.69). Hospital location in a metropolitan statistical area was associated with increased corticosteroid use in asthma (OR, 1.76; 95% CI, 1.10-2.82). Factors including sex, ethnicity, insurance, or region of the country were not significantly associated with corticosteroid use. CONCLUSIONS: During a 15-year period, knowledge transfer by passive diffusion or active guideline dissemination resulted in similar trends of corticosteroid use for the management of pediatric asthma and croup.

Assessment of HIV-related stigma in a US faith-based HIV education and testing intervention.

INTRODUCTION: The African American church is a highly influential institution with the potential to greatly increase the reach of HIV prevention interventions and address HIV-related stigma in US African American communities. However, there are few studies on HIV-related stigma and African American church populations. This study explored HIV-related stigma among church and community members participating in an HIV education and testing intervention pilot study in African American churches, named Taking It to the Pews. METHODS: Four African American churches located in Kansas City, MO and KS, were randomized to either intervention or comparison groups. Churches assigned to the intervention group received religiously tailored HIV education, testing and compassion messages/activities (e.g. sermons, brochures/church bulletins, testimonials) via the Taking It to the Pews HIV Tool Kit. Comparison churches received non-religiously tailored HIV information. HIV-related stigma was assessed with 543 church members and with community members served through church outreach services (e.g. food/clothing pantries, social services) in the four churches. Participants completed surveys at baseline, 6 months and 12 months to assess their HIV-related stigma beliefs, exposure to intervention components and satisfaction with the study. RESULTS: At baseline, HIV-related stigma beliefs were similar across experimental groups and were quite low. Mean HIV-related stigma scores were not significantly different between experimental groups at 6 months (p=0.92) or at 12 months (p=0.70). However, mean HIV-related stigma scores within both groups showed decreasing trends at six months, which approached significance. Analysis of previously studied HIV-related stigma factors (e.g. age, gender, income, HIV knowledge, religiosity) did not yield changes in the null findings. Intervention group participants were highly exposed to several intervention components (sermons, HIV resource tables, posters, brochures/church bulletins). Overall, participants were highly satisfied with the intervention pilot study. CONCLUSIONS: African American churches may be well positioned to increase the reach of HIV prevention interventions to church and community members and could serve an important role in addressing HIV-related stigma in their church communities. Future research is needed on measuring HIV-related stigma beliefs and on testing intensive, scalable, religiously tailored HIV interventions to impact HIV-related stigma in African American churches.

Variation and trends in ED use of radiographs for asthma, bronchiolitis, and croup in children.

OBJECTIVES: The objectives were (1) to determine trends in radiograph use in emergency department (ED) care of children with asthma, bronchiolitis, and croup; and (2) to examine the association of patient and hospital factors with variation in radiograph use. METHODS: A retrospective, cross-sectional study of National Hospital Ambulatory Medical Care Survey data between 1995 and 2009 on radiograph use at ED visits in children aged 2 to 18 years with asthma, aged 3 months to 1 year with bronchiolitis, and aged 3 months to 6 years with croup. Odds ratios (ORs) were calculated and adjusted for all factors studied. RESULTS: The use of radiographs for asthma increased significantly over time (OR: 1.06; 95% confidence interval [CI]: 1.03-1.09; P < .001 for trend) but were unchanged for bronchiolitis and croup. Pediatric-focused EDs had lower use for asthma (OR: 0.44; 95% CI: 0.29-0.68), bronchiolitis (OR: 0.37; 95% CI: 0.23-0.59), and croup (OR: 0.34; 95% CI: 0.17-0.68). Compared with the Northeast region, the Midwest and South had statistically higher use of radiographs for all 3 conditions. The Western region had higher use only for asthma (OR: 1.67; 95% CI: 1.07-2.60), and bronchiolitis (OR: 2.94; 95% CI: 1.48-5.87). No associations were seen for metropolitan statistical area or hospital ownership status. CONCLUSIONS: The ED use of radiographs for children with asthma increased significantly from 1995 to 2009. Reversing this trend could result in substantial cost savings and reduced radiation. Pediatric-focused EDs used significantly fewer radiographs for asthma, bronchiolitis, and croup. The translation of practices from pediatric-focused EDs to all EDs could improve performance.

On the Existence of Constant Accrual Rates in Clinical Trials and Direction for Future Research.

Many clinical trials fall short of their accrual goals. This can be avoided with accurate accrual prediction tools. Past researchers provide important methodological alternative models for predicting accrual in clinical trials. One model allows for slow accrual at the start of the study, which eventually reaches a threshold. A simpler model assumes a constant rate of accrual. A comparison has been attempted but we wish to point out some important considerations when comparing these two models. In fact, we can examine the reasonableness of a constant accrual assumption (simpler model) which had data 239 days into a three-year study. We can now update that and report accumulated from the full three years of accrual data and we can demonstrate that constant accrual rate assumption was met in this particular study. We will use this report to frame future research in the area of accrual prediction.

Evaluation of a breastfeeding assessment score in a diverse population.

A previous study performed in a predominately suburban population developed a breastfeeding assessment score (BAS) that was designed to predict, prior to hospital discharge, those mothers who would discontinue breastfeeding within the first 10 days of age. The purpose of the present study was to assess the BAS in a more diverse population. Patients were solicited from 3 urban hospitals serving patients primarily supported by public funding. Results of the present study with 1182 mother-infant pairs confirmed that 5 variables scored on a 0-2 scale (maternal age, previous breastfeeding experience, latching difficulty, breastfeeding interval, number bottles) remained highly significant for predicting discontinuation of breastfeeding. The data also demonstrate that the BAS is inversely related to the risk of cessation of breastfeeding at 7 to 10 days of age. Those at an early risk of cessation of breastfeeding, identified by the BAS, may benefit from early identification and a lactation consultation.

Noninvasive radial artery tonometry augmentation index and urinary albumin/creatinine levels in early adolescents with type 1 diabetes mellitus.

Patients with type 1 diabetes mellitus (DM1) are at an even greater risk compared to the general population for the development of cardiovascular disease. Studies have determined that the pathological changes seen in atherosclerosis develop at a very early age. There is a growing consensus within the medical community that early identification of chronic disease may help to reduce morbidity and mortality. The aim of this study was to assess the degree of arterial stiffness by measuring the augmentation index (AIx), using noninvasive radial artery tonometry, in adolescent children with DM1 compared with age-matched controls. In addition, urinary albumin/creatinine ratios were obtained to assess a possible relationship between renal and cardiac dysfunction in patients with DM1. Forty-five adolescents with DM1 and 42 controls between the ages of 12 and 14 years were recruited. Radial artery stiffness and urinary albumin/creatinine ratios of the adolescents with DM1 were not different from controls.

Pediatric out-of-hospital emergency medical services utilization in Kansas City, Missouri.

OBJECTIVES: The objective was to describe epidemiologic features and usage patterns of pediatric emergency medical services (EMS) transports in Kansas City, Missouri. METHODS: The study consisted of a retrospective analysis of transports from January 1, 2002, to December 31, 2004, for Kansas City, Missouri, residents younger than 15 years of age (excluding interfacility transports. Data included demographics, insurance, day and time of transport, patient zip code, chief complaint, and number of individual transports. Rates were calculated using intercensal estimates for the denominator. All rates were expressed as number of transports per 1,000 persons per year (PPY). RESULTS: A total of 5,717 pediatric transports occurred in the 3-year study period. Transport rates were 18 PPY for all users, 42 PPY for those <1 year old, 23 PPY for ages 1-4 years, 12 PPY for ages 5-9 years, and 14 PPY for ages 10-14 years. Infants <1 year were more likely than children aged 5-9 years to use EMS (relative risk [RR] = 3.7, 95% confidence interval [CI] = 3.4 to 4.0). Males were more likely than females to use EMS (RR = 1.2, 95% CI = 1.1 to 1.3). Most (64%) were insured by Medicaid. Transports peaked between 4 pm and 8 pm, and lowest usage was 4 am to 8 am (p < 0.001). Overall usage did not vary by weekday or season. Respiratory transports were more common in the fall and winter, while trauma transports were more common in the summer (p < 0.001). The most common diagnoses were trauma (27%), neurologic (19%), and respiratory (18%). Eleven percent of users accessed EMS more than once (26% of all transports). There was a significant inverse linear relationship between transport rate and median family income by zip code (r = -0.36, p < 0.001). CONCLUSIONS: Children in zip codes with lower incomes, infants, and males were more likely to use EMS. Factors related to these increased transport rates are unknown.

Quality of care for common pediatric respiratory illnesses in United States emergency departments: analysis of 2005 National Hospital Ambulatory Medical Care Survey Data.

OBJECTIVE: The goal was to measure US emergency department performance in the pediatric care of asthma, bronchiolitis, and croup, by using systematically developed quality indicators. METHODS: Data on visits to emergency departments by children 1 to 19 years of age with moderate/severe asthma, 3 months to 2 years of age with bronchiolitis, and 3 months to 3 years of age with croup from the 2005 National Hospital Ambulatory Medical Care Survey, with a nationally representative sample of US patients, were analyzed. We used national rates of use of corticosteroids, antibiotics, and radiographs as our main outcome measures. RESULTS: Physicians prescribed corticosteroids in 69% of the estimated 405,000 annual visits for moderate/severe asthma and in 31% of the estimated 317,000 annual croup visits. Children with bronchiolitis received antibiotics in 53% of the estimated 228,000 annual visits. Physicians obtained radiographs in 72% of bronchiolitis visits and 32% of croup visits. CONCLUSIONS: Physicians treating children with asthma, bronchiolitis, and croup in US emergency departments are underusing known effective treatments and overusing ineffective or unproven therapies and diagnostic tests.

Variations in psychological profile among children with recurrent abdominal pain.

This study was designed to determine whether distinct subgroups of children with recurrent abdominal pain (RAP) could be identified based on patterns of psychological functioning. Two hundred and eighty-three children (ages 8-17 years), and a primary caretaker, completed the Behavior Assessment System for Children (BASC) during the initial evaluation of RAP at a pediatric gastroenterology clinic. Cluster analysis of BASC scores supported a 3-cluster solution, with fair agreement observed between parents and children on cluster assignment. Approximately half of the sample identified no significant psychological problems. A small percentage (13%) evidenced intense and broad-based psychological problems, while the remainder (35-45%) indicated relative elevations in anxiety only. Cluster membership did not vary systematically by age, gender, race, or functional gastrointestinal disorder diagnosis. Distinct psychological profiles appear to exist for children with RAP. Targeting treatments to these profiles may improve the effectiveness and efficiency with which health professionals address pediatric abdominal pain.

Double probing of human spermatozoa for persistent histones, surplus cytoplasm, apoptosis and DNA fragmentation.

Individual spermatozoa were assessed with pairs of probes for persistent histones and cytoplasmic retention, persistent histones and DNA fragmentation, and persistent histones and apoptotic markers. The individual spermatozoa were treated sequentially with combinations of probes for these cytoplasmic and nuclear biochemical markers. Sperm fields were recorded with computer-assisted imaging, and staining patterns with the two probes in the same spermatozoa were examined and scored as light, intermediate or dark (mature to arrested-maturity spermatozoa). The effects of arrested sperm maturation were similar with respect to the cytoplasmic and nuclear characteristics of spermatozoa in 84% of cells, indicating that cytoplasmic and nuclear attributes of arrested sperm maturation are related. However, there were moderate (intermediate-dark or intermediate-light patterns, 14.5% of cells) or major (light-dark patterns, 1.6% of cells) discrepancies in the intensity of the double staining patterns. Thus, testing with single maturity markers may not be fully reliable. These findings are important with respect to: (i) arrested sperm maturation; (ii) potential efficacy of antioxidant and similar therapeutic strategies in subfertile men, as spermatozoa with infrastructure defects due to mismaturation or maturation arrest are unlikely to respond to interventions; and (iii) detection of adverse male environmental exposures.

Interindividual variability in acetaminophen sulfation by human fetal liver: implications for pharmacogenetic investigations of drug-induced birth defects.

BACKGROUND: Acetaminophen (APAP) use in early pregnancy has been associated with the risk of gastroschisis, a rare but serious congenital defect of the abdominal wall. The purpose of this study was to characterize the variability of APAP sulfation in a panel of human fetal livers and to identify the sulfotransferases (SULT) isoform(s) responsible for catalyzing that activity. METHODS: APAP sulfation was determined in a panel of human fetal (n = 73) and postnatal (n = 18) liver cytosol preparations and correlated with the catalytic activity of various SULT isoforms as determined using prototypic substrates and specific antibodies. RESULTS: Of 10 heterologously expressed SULT isoforms examined, SULT1A1, SULT1A3/4, SULT1E1, and SULT2A1 all catalyzed the formation of APAP sulfate with K(m) values of 2.4, 1.5, 1.9, and 3.7 mM, respectively. Catalytic activities for these four isoforms were expressed at varying levels in human fetal liver, and APAP sulfation was positively correlated with each of the four prototypic activities. Several regression and clustering approaches revealed that SULT1A3/4 was the primary determinant of prenatal APAP sulfation but that SULT1A1 or SULT1E1 were also major contributors in subsets of samples. CONCLUSIONS: The results of this study lead to the hypothesis that genetic variation in SULT1A3/4 represents a risk factor for the development of gastroschisis in the offspring of mothers exposed to APAP early in pregnancy. Interpretation of genetic association studies conducted to test this hypothesis will be complicated by the variable contributions of other SULTs toward APAP-sulfate formation in individual subjects.

Predicting accrual in clinical trials with Bayesian posterior predictive distributions.

Investigators need good statistical tools for the initial planning and for the ongoing monitoring of clinical trials. In particular, they need to carefully consider the accrual rate-how rapidly patients are being recruited into the clinical trial. A slow accrual decreases the likelihood that the research will provide results at the end of the trial with sufficient precision (or power) to make meaningful scientific inferences. In this paper, we present a method for predicting accrual. Using a Bayesian framework we combine prior information with the information known up to a monitoring point to obtain a prediction. We provide posterior predictive distributions of the accrual. The approach is attractive since it accounts for both parameter and sampling distribution uncertainties. We illustrate the approach using actual accrual data and discuss practical points surrounding the accrual problem.