Functional gallbladder disorder: Interim analysis of a prospective cohort study.

BACKGROUND: Functional gallbladder disorder (FGBD) remains a controversial indication for cholecystectomy. METHODS: A prospective cohort study enrolled patients strictly meeting Rome criteria for FGBD, and cholecystectomy was performed. They were assessed pre- and 3 and 6 months postoperatively with surveys of abdominal pain and quality of life (RAPID and SF-12 surveys, respectively). Interim analysis was performed. RESULTS: Although neither ejection fraction nor pain reproduction predicted success after cholecystectomy, the vast majority of enrolled patients had a successful outcome after undergoing cholecystectomy for FGBD: of a planned 100 patients, 46 were enrolled. Of 31 evaluable patients, 26 (83.9 â€‹%) reported RAPID improvement and 28 (93.3 â€‹%) SF12 improvement at 3- or 6-month follow-up. CONCLUSION: FGBD, strictly diagnosed, should perhaps no longer be a controversial indication for cholecystectomy, since its success rate for biliary pain in this study was similar to that for symptomatic cholelithiasis. Larger-scale studies or randomized trials may confirm these findings.

Efficacy of COVID-19 Convalescent Plasma Based on Antibody Concentration.

Background: Convalescent plasma obtained from individuals who have recovered from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) contains neutralizing antibodies to the virus and has been frequently used as a treatment in hospitalized patients with severe COVID-19. Methods: We conducted a retrospective, observational cohort study involving 96 hospitalized patients with severe COVID-19 who were allocated in a 1 : 1 ratio to having received either high antibody concentration convalescent plasma or low antibody concentration convalescent plasma. Quantitative measurements of IgG to the receptor-binding domain (RBD), the S1 subunit of the spike protein, and the SARS-CoV-2 nucleocapsid (N) protein were determined from donor plasma samples. The primary outcome was all-cause mortality within 30 days following convalescent plasma administration in regard to each of the three antibody domains. Results: Within the nucleocapsid antibody domain, death occurred in 22.2% of patients in the low antibody concentration group versus 23.5% in the high antibody concentration group (p=0.88). Within the RBD antibody domain, death occurred in 22.9% of patients in both the low and the high antibody concentration groups (p=1.0). Within the S1 subunit antibody domain, death occurred in 27.1% of patients in the low antibody concentration group versus 18.8% in the high antibody concentration group (p=0.33). Conclusions: No significant differences were observed between low and high concentration convalescent plasma in regard to overall mortality at 30 days, hospital length of stay, number of ventilator days, and subsequent receipt of invasive mechanical ventilation in patients who were previously not receiving mechanical ventilation. Trial Registration. This study was not associated with a clinical trial due to the retrospective nature of study design.

Is Staple Line Reinforcement Necessary in Conversion From Laparoscopic Adjustable Band to Laparoscopic Sleeve Gastrectomy?

BACKGROUND: Once a common bariatric procedure, laparoscopic adjustable gastric band (LAGB) is more frequently the subject of conversion procedures, particularly to laparoscopic sleeve gastrectomy (LSG), due to failure of weight loss, weight regain, and band intolerance. Staple line reinforcement (SLR) in primary LSG has been studied extensively, but has not been evaluated in revision procedures. The aim of this study is to investigate commonly used SLR techniques and their effects on morbidity and mortality in single-stage bands converted to sleeves. METHODS: The Metabolic and Bariatric Surgery Accreditation Quality and Improvement Program (MBSAQIP) Participant Use Data Files (PUF) for 2015-2016 were utilized to assess data for single-stage bands converted to sleeves based on CPT codes, and records were stratified by technique of staple line reinforcement. The database contained all the defined variables utilized for analysis with the exception of leak rate and overall morbidity, which had to be derived. Thirty-day outcomes were analyzed using multiple bivariate analyses and Bonferroni corrections were applied. RESULTS: Of the 6,286 patients who underwent single-stage bands converted to sleeves for whom SLR data is available, 56.9% of surgeons utilized SLR only, 21.3% chose no reinforcement technique (No SLR), 13.4% chose SLR plus over-sewing of the staple line (SLR+OSL), and 8.4% chose OSL alone. There were no statistically significant differences in rates of death, reoperation, readmission, reintervention, number of bleeding events, and staple line leaks across groups. CONCLUSION: Choice of SLR does not affect number of bleeding events or staple line leak rate.

Trends and seasonality in hospitalizations for acute alcohol-related and biliary pancreatitis in the USA.

BACKGROUND: The incidence of acute pancreatitis (AP) is characterized by circannual and geographical variation. The aim of this study was to describe seasonal variation and trends in hospitalizations for AP in the USA with respect to AP etiology. METHODS: The Nationwide Inpatient Sample data (2000-2016) from the Healthcare Cost and Utilization Project were used. The study population included all primary hospitalizations for AP. Biliary AP (BAP) and alcohol-induced AP (AAP) were distinguished by diagnostic and procedural ICD codes. Seasonal trend decomposition was performed. RESULTS: There was a linear increase in annual incidence (per 100 000 population) of AAP in the USA (from 17.0 in 2000 to 22.9 in 2016), while incidence of BAP, equaled 19.9 in 2000, peaked at 22.1 in 2006 and decreased to 17.4 in 2016. AP incidence demonstrated 18% annual incidence amplitude with summer peak and winter trough, more prominent in AAP. In 2016, within AAP, the highest incidence (per 100 000 population) was noted among African-Americans (up to 50.4), followed by males aged 56-70 years (26.5) and Asians of low income (25.5); within BAP, above the average incidence was observed in Hispanic (up to 25.8) and Asian (up to 25.0) population. The most consistent and rapid increase in AP incidence was noted in males aged 56-70 years with an alcoholic etiology (average 6% annual incidence growth). CONCLUSIONS: The incidence and annual trends of AP vary significantly among demographic and socioeconomic groups and this knowledge may be useful for the planning of healthcare resources and identification of at-risk populations.

Measured versus Estimated Blood Loss: Interim Analysis of a Prospective Quality Improvement Study.

Estimated blood loss (EBL) is an increasingly important factor used to predict outcomes, such as morbidity and mortality, length of stay, and readmissions, after major abdominal operations. However, blood loss is difficult to estimate, with frequent under- and overestimations, consequences of which can be potentially dangerous for individual patients and confounding for scoring systems relying on EBL. We hypothesized that EBL is often inaccurate and have prospectively enrolled consecutive patients undergoing major elective intra-abdominal operations. Actual hemoglobin levels were measured and used to calculate the measured blood loss (MBL), which was compared with the EBL, as estimated both by surgeons (sEBL) and anesthesiologists (aEBL). Of 23 eligible cases at interim analysis, pancreaticoduodenectomy (n = 8) was the most common, followed by colectomy (n = 3), hepatectomy (n = 3) and gastrectomy (n = 2), biliary excision and reconstruction (n = 2), combined gastrectomy + colectomy (n = 1), radical nephrectomy (n = 1), open cholecystectomy (n = 1), pancreatic debridement (n = 1), and exploratory laparotomy (n = 1). aEBL overestimated MBL by 192 mL (143%) on average. The aEBL was significantly greater than the MBL (P = 0.004), whereas the sEBL was significantly less than the MBL (P = 0.009). In conclusion, surgeons significantly underestimate and anesthesiologists significantly overestimate EBL. This finding impacts not only immediate patient care but also the interpretation of scoring systems relying on EBL.

Detecting accidental punctures and lacerations during cholecystectomy in large datasets: Two methods of analysis.

BACKGROUND: After the Institute of Medicine (IOM) report To Err Is Human highlighted the impact of medical errors, the Agency for Healthcare Research and Quality (AHRQ) developed Patient-Safety Indicators (PSI) to improve quality by identifying potential inpatient safety problems. PSI-15 was created to study accidental punctures and lacerations (APL), but PSI-15 may underestimate APLs in populations of patients. This study compares PSI-15 with a more inclusive approach using a novel composite of secondary diagnostic and procedural codes. METHODS: We used Nationwide Inpatient Sample (NIS) data (2000-2012) from AHRQ's Healthcare Cost and Utilization Project (H-CUP). We analyzed PSI-15-positive and -negative cholecystectomies. Cross tabulations identified codes that were significantly more frequent among PSI-15-positive cases; these secondary diagnostic and procedural codes were selected as candidate members of a composite marker (CM) of APL. We chose cholecystectomy patients for study because this is one of the most common general operations, and the large size of NIS allows for meaningful analysis of infrequent occurrences such as APL rates. RESULTS: CM identified 1.13 times more APLs than did PSI-15. Patients with CM-detected APLs were significantly older and had worse mortality, comorbidities, lengths of stay, and charges than those detected with PSI-15. Further comparison of these two approaches revealed that time-series analysis for both APL markers revealed parallel trends, with inflections in 2007, and lowest APL rates in July. CONCLUSIONS: Although CM may yield more false positives, it appears more inclusive, identifying more clinically significant APLs, than PSI-15. Both measures presented similar trends over time, arguing against inflation in PSI-15 reporting. While arguably less specific, CM may increase sensitivity for detecting APL events during cholecystectomies. These results may inform the interpretation of other large population studies of APLs following abdominal operations.

Clues to predict incidental gallbladder cancer.

BACKGROUND: Consequences of incidental gallbladder cancer (iGBC) following cholecystectomy may include repeat operation (depending on T stage) and worse survival (if bile spillage occurred), both avoidable if iGBC were suspected preoperatively. METHODS: A retrospective single-institution review was done. Ultrasound images for cases and controls were blindly reviewed by a radiologist. Chi-square and Student's t tests, as well as logistic regression and Kaplan-Meier analyses were used. A P ≤ 0.01 was considered significant. RESULTS: Among 5796 cholecystectomies performed 2000-2013, 26 (0.45%) were iGBC cases. These patients were older (75.61 versus 52.27 years), had more laparoscopic-to-open conversions (23.1% versus 3.9%), underwent more imaging tests, had larger common bile duct diameter (7.13 versus 5.04 mm) and higher alkaline phosphatase. Ultrasound imaging showed that gallbladder wall thickening (GBWT) without pericholecystic fluid (PCCF), but not focal-versus-diffuse GBWT, was associated significantly with iGBC (73.9% versus 47.4%). On multivariable logistic regression analysis, GBWT without PCCF, and age were the strongest predictors of iGBC. The consequences iGBC depended significantly on intraoperative bile spillage, with nearly all such patients developing carcinomatosis and significantly worse survival. CONCLUSIONS: Besides age, GBWT, dilated common bile duct, and elevated alkaline phosphatase, number of preoperative imaging modalities and the presence of GBWT without PCCF are useful predictors of iGBC. Bile spillage causes poor survival in patients with iGBC.

Minimally invasive and open gallbladder cancer resections: 30- vs 90-day mortality.

BACKGROUND: Minimally invasive surgery is increasingly used for gallbladder cancer resection. Postoperative mortality at 30 days is low, but 90-day mortality is underreported. METHODS: Using National Cancer Database (1998-2012), all resection patients were included. Thirty- and 90-day mortality rates were compared. RESULTS: A total of 36 067 patients were identified, 19 139 (53%) of whom underwent resection. Median age was 71 years and 70.7% were female. Ninety-day mortality following surgical resection was 2.3-fold higher than 30-mortality (17.1% vs 7.4%). There was a statistically significant increase in 30- and 90-day mortality with poorly differentiated tumors, presence of lymphovascular invasion, tumor stage, incomplete surgical resection and low-volume centers (P<0.001 for all). Even for the 1885 patients who underwent minimally invasive resection between 2010 and 2012, the 90-day mortality was 2.8-fold higher than the 30-day mortality (12.0% vs 4.3%). CONCLUSIONS: Ninety-day mortality following gallbladder cancer resection is significantly higher than 30-day mortality. Postoperative mortality is associated with tumor grade, lymphovascular invasion, tumor stage, type and completeness of surgical resection as well as type and volume of facility.

Age-related differences pre-, intra-, and postcholecystectomy: A retrospective cohort study of 6,868 patients.

BACKGROUND: Cholecystectomy (CCY) is increasingly performed in older individuals. We sought to examine age-related differences in pre-, intra-, and postoperative factors at a community hospital, using a very large, single-institution cholecystectomy database. MATERIALS AND METHODS: A retrospective review of 6868 patients who underwent CCY from 2001 to 2013 was performed. ROC analysis identified the optimal age cutoff when complications reached a significant inflection point (<55 and ≥55 years). Multiple clinical features and outcomes were measured and compared by age. Logistic regression was used to examine how well a set of covariates predicted postoperative complications. RESULTS: Older patients had significantly higher rates of comorbidities and underwent more extensive preoperative imaging. Intraoperatively, older patients had more blood loss, longer operative times, and more open operations. Postoperatively, older patients experienced more complications and had significantly different pathological findings. While holding age and gender constant, regression analyses showed that preoperative creatinine level, blood loss and history of previous operation were the strongest predictors of complications. The risk for developing complications increased by 2% per year of life. CONCLUSION: Older patients have distinct pre-, intra-, and postoperative characteristics. Their care is more imaging- and cost-intensive. CCY in this population is associated with higher risks, likely due to a combination of comorbidities and age-related worsened physiological status. Pathologic findings are significantly different relative to younger patients. While removing the effect of age, preoperative creatinine levels, blood loss, and history of previous operation predict postoperative complications. Quantifying these differences may help to inform management decisions for older patients.

Assessment of Two Rapid Assays for Diagnostic Capability to Accurately Identify Infection by Treponema pallidum.

BACKGROUND: Rapid, point-of-care tests that accurately identify syphilis are gaining popularity and offer several advantages over classic tests. METHODS: The SD Bioline Syphilis 3.0 and the Chembio DPP Syphilis Screen and Confirm Assay (CB) were assessed using 1283 samples that had been characterized by reference tests. The challenge samples included 5 commercial panels (seroconversion, mixed-titer), archived samples, fresh samples, and a dilution series. Both tests detect specific anti-treponemal antibodies, and the CB additionally detects antibodies to a non-treponemal (NT) component. The evaluation was used to determine performance indices and compare with those cited by the manufacturers. RESULTS: When assessing reactivity to treponemal, the sensitivities for the 2 tests were 98.3% and 93.2%, with specificities of 100% and 99.4%, respectively. For both tests, precision, whole blood testing, and high-temperature testing produced perfect results, and there were no invalid results. Comparisons of 2 different lots of each test indicated excellent concordance (100% and 99.5%), and reproducibility was 100% and 98.0%, respectively. For the CB, the sensitivity for the NT component was between 65.3% and 80.9%, but increased to 98.5% with samples having a rapid plasma regain (RPR) titer of ≥8. The specificity for NT was found to be 100%, and the reading of results visually and when using a battery-operated reader indicated a concordance for all challenges of 95%-100%. CONCLUSIONS: Both rapid tests produced impressive results for the detection of antibodies to treponemal for all challenges and exceeded, met, or closely approached the performance characteristics as cited by the manufacturers.

Financial impact of a targeted reduction in cardiac enzyme testing at a community hospital.

OBJECTIVES: Nearly one-third of healthcare costs are potentially avoidable and would not compromise medical care if eliminated. Therefore, we sought to evaluate the financial impact of reduction in use of creatinine kinase (CK)-MB and myoglobin tests after removing them from the cardiac enzyme order set at a community hospital. METHODS: Grand rounds were held, and an email notification was sent to de-emphasize the use of CK, CK-MB, myoglobin, SGOT (glutamic-oxaloacetic transaminase), and SGPT (serum glutamic-pyruvic transaminase) in acute coronary syndrome (ACS) work up. The above tests were removed from the pre-checked cardiac enzyme order set in the computerized physician order entry on February 13, 2014. The tests continued to be available, but needed to be ordered individually. The mean monthly volume of cardiac enzyme tests for 12 months after this intervention was compared with the mean monthly volume of 12 months before the change. Total cost savings were calculated. RESULTS: After the intervention, the number of CK, CK-MB, myoglobin, SGOT, and SGPT tests utilized for ACS workup decreased dramatically (p<0.001). The volume of troponin testing remained the same (p=0.283). The total annual savings of billable charges to healthcare payers was $463,744.7. CONCLUSIONS: Removal of CK-MB, myoglobin, CK, SGOT, and SGPT tests from cardiac enzyme order sets can successfully reduce unnecessary laboratory testing for ACS workup, leading to significant cost savings to the healthcare system.

Effect of Residents on Operative Time and Complications: Focus on Laparoscopic Cholecystectomy in the Community.

OBJECTIVE: To better understand important aspects of resident education in the perioperative setting, given that there are conflicting data regarding resident training and outcomes (e.g., operative times and complications). To study continuity of care in a resident-run outpatient hospital clinic. DESIGN: Retrospective analysis of 2 databases. SETTING: The study was set up in a community teaching hospital. RESULTS: Of 4603 cases in a cholecystectomy database, 3302 (72%) were assisted by residents, with operative times ranging from 19 to 383 minutes, and 1576 (22.9%) were assisted by nonresidents. The average times were 93 and 77 minutes for resident- and non-resident-assisted cases, respectively. Complications were almost 3 times more likely for urgent vs. elective but were similar for resident-assisted vs. non-resident-assisted cases. The operative time was similar across PGY levels. Of 149 cases in a resident-run outpatient clinic, 100 (67%) of the residents participated in preoperative, intraoperative, and postoperative phases of case, but in only 4% of cases was it the same resident. CONCLUSION: Resident assistance increased operative times but not complications. Counterbalanced effects of increasing skill and increasing participation may explain this time stability across PGY levels. Continuity of care is preserved in the era of the 80-hour workweek, but not to a patient-specific degree.

Intrahepatic pancreatic pseudocyst: A review of the world literature.

AIM: To investigate and summarize the literature regarding the diagnosis and management of intrahepatic pancreatic pseudocysts (IHPP). METHODS: A literature search was performed using PubMed (MEDLINE) and Google Scholar databases, followed by a manual review of reference lists to ensure that no articles were missed. All articles, case reports, systematic reviews, letters to editors, and abstracts were analyzed and tabulated. Bivariate analyses were performed, with significance accepted at P < 0.05. Articles included were primarily in the English language, and articles in other languages were reviewed with native speakers or, if none available, were translated with electronic software when possible. RESULTS: We found 41 published articles describing 54 cases since the 1970s, with a fairly steady rate of publication. Patients were predominantly male, with a mean age of 49 years. In 42% of published cases, the IHPP was the only reported pseudocyst, but 58% also had concurrent pseudocysts in other extrapancreatic locations. Average IHPP size was 9.5 cm and they occurred most commonly (48%) in the left hemiliver. Nearly every reported case was managed with an intervention, most with a single intervention, but some required up to three interventions. Percutaneous treatment with either simple aspiration or with an indwelling drain were the most common interventions, frequently performed along with stenting of the pancreatic duct. The size of the IHPP correlated significantly with both the duration of treatment (P = 0.006) and with the number of interventions required (P = 0.031). The duration of therapy also correlated with the initial white blood cell (WBC) count (P = 0.048). CONCLUSION: Diagnosis of IHPP is difficult and often missed. Initial size and WBC are predictive of the treatment required. With appropriate intervention, most patients achieve resolution.

Implications of gallbladder cholesterolosis and cholesterol polyps?

BACKGROUND: The clinical significance of cholesterolosis has not been well established but there are some provocative, if not robust, studies of the role it may play in the pathophysiology of pancreatitis and biliary dyskinesia, as well as hypercholesterolemia. Our aim was to take advantage of a very large cholecystectomy (CCY) database to support or refute these potentially important reported associations. MATERIALS AND METHODS: A retrospective review of 6868 patients who underwent CCY from 2001-2013 was performed. Comparisons were made using the student t-test for continuous and chi-square analysis for categorical, variables. RESULTS: Among patients for whom the CCY was the primary operation, 1053 (18%) had cholesterolosis and 4596 did not. Compared to those without cholesterolosis, those with cholesterolosis were no more likely to have elevated cholesterol levels (P = 0.64) nor low gallbladder ejection fraction (P = 0.2). To evaluate cholesterolosis as a cause of pancreatitis, all patients with gallstones were eliminated, leaving 639 patients. Among these, not only was cholesterolosis not associated with more pancreatitis, but rather there was not a single patient with or without cholesterolosis who had pancreatitis. CONCLUSIONS: Despite prior reports of associations between cholesterolosis and elevated serum cholesterol, depressed ejection fraction, and increased risk of pancreatitis, careful analysis of this current, larger data set does not support these associations. Any patient with stones or sludge, or with biliary dyskinesia, and appropriate symptoms, should be considered for CCY, with or without suspected cholesterolosis.

Patient safety, error reduction, and pediatric nurses' perceptions of smart pump technology.

Patient safety and error reduction are essential to improve patient care, and new technology is expected to contribute to such improvements while reducing costs and increasing care efficiency in health care organizations. The purpose of this study was to assess the relationships among pediatric nurses' perceptions of smart infusion pump (SIP) technology, patient safety, and error reduction. Findings revealed that RNs' perceptions of SIP correlated with patient safety. No significant relationship was found between RNs' perceptions of SIP and error reduction, but data retrieved from the pumps revealed 93 manipulations of the pumps, of which error reduction was captured 65 times.

Pediatric fasting times before surgical and radiologic procedures: benchmarking institutional practices against national standards.

Prolonged preoperative fasting can be associated with adverse outcomes, particularly in children. Our aims were to assess the time pediatric patients fasted prior to surgical or radiologic procedures and evaluate whether fasting (NPO) orders complied with national guidelines. We measured NPO start time, time of last intake, and time test or surgery was scheduled, took place, or was cancelled in 219 pediatric patients. Findings demonstrate that pediatric patients experienced prolonged fasting before procedures and that the majority of NPO orders were non-compliant with national guidelines. We have developed strategies to reduce fasting times and ensure compliance with recommended national fasting standards.

Predictors of antiretroviral medication adherence among a diverse cohort of adolescents with HIV.

PURPOSE: To compare prevalence and describe predictors of antiretroviral treatment adherence among adolescents with HIV acquired perinatally (PIY) or through risk behaviors (BIY). METHODS: Data were obtained from the baseline assessment of Adolescent Impact, an intervention for HIV-infected adolescents receiving care in three U.S. cities. Patients self-reported missed medication doses as well as medication factors, HIV knowledge, disclosure, substance use, mental health, and social support through face-to-face or computer-assisted interviews. RESULTS: Of 104 participants, 68 (65.4%) reported full adherence. Compared with BIY, PIY were younger, had greater HIV disease severity, and had more structural supports. Adjusting for transmission mode (PIY vs. BIY), nonadherence by self-report was associated with higher viral load (VL) (adjusted odds ratio [AOR] = 1.5, confidence interval [CI] = 1.03, 2.18). Nonadherent adolescents were significantly likely to have had AIDS, discussed HIV disease with providers, reported difficulty with medication routine, experienced internalizing behavior problems, and used drugs. In multivariate analyses, independent predictors of nonadherence included acquiring HIV behaviorally (AOR = 4.378, CI = 1.055, 18.165), ever having AIDS (AOR = 4.78, CI = 1.31, 17.49), perceiving difficult medication routine (AOR = 1.84, CI = 1.07, 3.16), discussing disease indicators with provider (AOR = 4.57, CI = 1.74, 11.98), and missing doses because of forgetting (AOR = 2.53, CI = 1.29, 4.96). Adjusting for transmission mode, detectable VL was associated with lower recent CD4(+) lymphocyte counts, discussing disease indicators with providers, and missing doses because of forgetting or being depressed. Low recent CD4(+) lymphocyte counts (AOR = .988, p = .024) but fewer HIV symptoms (AOR = .466, p = .032) and missing doses because of forgetting (AOR = 1.76, p = .05) were independently associated with detectable VL in multivariate analysis. CONCLUSIONS: Despite differences between groups, nonadherence was associated with severity of illness, difficult medication routine, and forgetfulness. Beyond individual needs, both groups of adolescents had suboptimal adherence and would benefit from simplified medication routines and organizational skills.

The experiences of children enrolled in pediatric oncology research: implications for assent.

BACKGROUND: Most children with cancer enroll in clinical research trials. Whenever possible, children must provide their assent before enrolling in research studies. We studied what children aged 7 to 18 with cancer understand about research, their research-related treatment, and their preferences for inclusion in decision-making. PROCEDURE: Thirty-seven face-to-face, audiorecorded interviews using a novel, semi-structured tool, the quality-of-assent instrument, were conducted. Exploratory univariate and bivariate analyses of the quantitative data elucidated patterns and trends of understanding and preferences. RESULTS: Nineteen of the 37 children (51%) did not know or recall that their treatment was considered research, and 19 of 22 (86%) did not understand their doctor when he or she discussed the trial. More children enrolled in trials to help future children with cancer (27 of 37 [73%]), than to get better personally (22 of 37 [60%]). Irrespective of age, children with Hodgkin's disease, germ-cell tumors, and leukemia had significantly greater research awareness and appreciation than children with other cancers (P = .019 and P < .001, respectively). Although all children wanted to be involved in decision-making, 18 of 37 (49%) did not have or recall having a role in deciding to enroll in their trial, and 14 of 37 (38%) did not feel free to dissent to trial enrollment. Only 4 of 37 children (11%) discussed increased decision-making roles with parents, and only 7 of 37 (19%) discussed them with their doctors. CONCLUSIONS: Most children have limited understanding of research despite physicians' explanations. Many children reported that they feel minimally involved in the decision to enroll in clinical trials. Tools to assist investigators ascertain that children understand what they are agreeing to when they assent to research and to determine their preferences for inclusion in research may help make assent more meaningful.

Demographic profiles of newly acquired HIV infections among adolescents and young adults in the U.S.

Understanding the demographic and risk profiles of youth with recent HIV infection offers insight for imputing the dynamics of the epidemic and targeting prevention efforts. Three hundred forty-two HIV-positive youth were tested using a Sensitive/Less Sensitive strategy; 33% were classified as recently infected; with the majority (51%) occurring within African Americans.