Randomized Trial of a Vaccine Regimen to Prevent Chronic HCV Infection.

BACKGROUND: A safe and effective vaccine to prevent chronic hepatitis C virus (HCV) infection is a critical component of efforts to eliminate the disease. METHODS: In this phase 1-2 randomized, double-blind, placebo-controlled trial, we evaluated a recombinant chimpanzee adenovirus 3 vector priming vaccination followed by a recombinant modified vaccinia Ankara boost; both vaccines encode HCV nonstructural proteins. Adults who were considered to be at risk for HCV infection on the basis of a history of recent injection drug use were randomly assigned (in a 1:1 ratio) to receive vaccine or placebo on days 0 and 56. Vaccine-related serious adverse events, severe local or systemic adverse events, and laboratory adverse events were the primary safety end points. The primary efficacy end point was chronic HCV infection, defined as persistent viremia for 6 months. RESULTS: A total of 548 participants underwent randomization, with 274 assigned to each group. There was no significant difference in the incidence of chronic HCV infection between the groups. In the per-protocol population, chronic HCV infection developed in 14 participants in each group (hazard ratio [vaccine vs. placebo], 1.53; 95% confidence interval [CI], 0.66 to 3.55; vaccine efficacy, -53%; 95% CI, -255 to 34). In the modified intention-to-treat population, chronic HCV infection developed in 19 participants in the vaccine group and 17 in placebo group (hazard ratio, 1.66; 95% CI, 0.79 to 3.50; vaccine efficacy, -66%; 95% CI, -250 to 21). The geometric mean peak HCV RNA level after infection differed between the vaccine group and the placebo group (152.51×103 IU per milliliter and 1804.93×103 IU per milliliter, respectively). T-cell responses to HCV were detected in 78% of the participants in the vaccine group. The percentages of participants with serious adverse events were similar in the two groups. CONCLUSIONS: In this trial, the HCV vaccine regimen did not cause serious adverse events, produced HCV-specific T-cell responses, and lowered the peak HCV RNA level, but it did not prevent chronic HCV infection. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT01436357.).

A Cautionary Tale: Digital Clinical Trial Implementation of a Couples-Based HIV Prevention Study among Transgender Women and Their Partners in the United States.

This study investigates baseline differences in couples enrolled in the "It Takes Two" HIV prevention intervention for transgender women and their partners, comparing in-person participation pre-COVID-19 and digital participation during the pandemic. Among 52 couples (40% in-person, 60% digital), bivariate analyses revealed that in-person participants were more likely to be African American, have cisgender male partners, report higher unemployment, incarceration histories, greater relationship stigma, and lower relationship quality. The findings highlight the limitations of digital modalities in engaging transgender women of color and those with structural vulnerabilities. The study emphasizes that reliance on digital methods in HIV research jeopardizes the inclusion of those lacking technological access and literacy, especially communities disproportionately impacted by HIV. Researchers must incorporate hybrid or in-person options and engage communities to ensure equity and inclusion, thus overcoming barriers and ensuring comprehensive population reach in HIV prevention studies.

Acute Coronary Syndrome at Altitude: Diagnostic Dilemma on Aconcagua Using Point-of-Care Ultrasound.

At the Plaza de Mulas medical tent, located at 4300 m (14,100 ft) along the Normal Route to the 6960 m (22,837 ft) summit of Aconcagua in Argentina, a Korean male in his 50s with no known medical conditions presented with lightheadedness and shortness of breath. He had taken sildenafil and acetazolamide that morning without improvement. Vital signs on arrival were notable for oxygen saturations in the high 60s with basilar crackles on lung auscultation, concerning for high altitude pulmonary edema. The patient was started on oxygen via nasal cannula and given dexamethasone. History was limited secondary to language barriers, but on review of systems the patient noted mild chest pressure. Bedside cardiac echocardiogram was performed, which revealed a septal wall motion abnormality. The patient was therefore given aspirin and clopidogrel and was flown to a lower trailhead, where he was met by local Emergency Medical Services. A 12-lead electrocardiogram revealed an anterior ST-elevation myocardial infarction, and the patient was taken emergently to the catheterization lab in Mendoza and underwent stent placement with a full recovery.

A Video-Observed Treatment Strategy to Improve Adherence to Treatment Among Persons Who Inject Drugs Infected With Hepatitis C Virus: Qualitative Study of Stakeholder Perceptions and Experiences.

BACKGROUND: Direct-acting antiviral medications have the potential to eliminate the hepatitis C virus (HCV) epidemic among people who inject drugs; yet, suboptimal adherence remains a barrier. Directly observed treatment (DOT), an effective strategy for optimizing adherence, has been frequently implemented in opioid treatment programs but less commonly in community health settings due to the heavy burden of daily visits. An alternative is video-observed therapy (VOT), which uses mobile health technology to monitor adherence. VOT has not been widely studied among people who inject drugs with HCV. OBJECTIVE: This qualitative study, part of a larger implementation evaluation, investigates stakeholder perceptions and experiences with VOT in Project HERO (Hepatitis C Real Outcomes), a multisite pragmatic trial testing treatment delivery models for people who inject drugs with HCV. Our goal was to understand the potential barriers and facilitators to the implementation of the VOT technology. METHODS: Qualitative interviews were conducted with 27 Project HERO study staff and 7 patients. Interviews focused on perceptions and experiences with the VOT app and barriers and facilitators to implementation. Team meeting minutes over the first 2 years of the project were transcribed. A coding system was developed and applied to the data. We summarized thematic data and compared participant perceptions to generate a close understanding of the data. RESULTS: Frequent barriers to VOT included mechanical failure, stolen or lost phones, and a steep learning curve for participants and study staff. In sites with older and less technically skilled participants, staff found it difficult to implement the VOT app. Research staff found that the routine monitoring of app use led to closer engagement with participants. This was both a benefit and a potential threat to the validity of this pragmatic trial. Patient participants reported mixed experiences. CONCLUSIONS: VOT may be a useful alternative to DOT for some patients, but it may not be feasible for all. Significant staff involvement may be required.

Factors predicting staging and treatment initiation for patients with chronic hepatitis C infection: insurance a key predictor.

BACKGROUND: Chronic hepatitis C (HCV) infection affects over 2.4 million Americans and accounts for 18 000 deaths per year. Treatment initiation in this population continues to be low even after introduction of highly effective and shorter duration direct-acting antivirals. This study assesses factors that influence key milestones in the HCV care continuum. METHODS: Retrospective time-to-event analyses were performed to assess factors influencing liver fibrosis staging and treatment initiation among individuals confirmed with chronic HCV infection at University of Illinois Hospital and Health Sciences System between 1 August 2015 and 24 October 2016 and followed through 28 January 2018. Cox regression models were utilized for multivariable analyses. RESULTS: Individuals tested at the liver clinic (hazard ratio [HR] = 2.03; 95% confidence interval [CI]: 1.19-3.46) and at the federally qualified health center (HR = 3.51; 95% CI: 2.19-5.64) had higher instantaneous probability of being staged compared with individuals tested at the emergency department (ED) or inpatient setting. And probability of treatment initiation increased with advancing liver fibrosis especially for Medicaid beneficiaries (HR = 1.64; 95% CI: 1.35-1.99). CONCLUSIONS: The study demonstrates a need for improving access for patients with early stages of the disease in order to reduce HCV-related morbidity and mortality, especially those tested at nontraditional care locations such as the ED or the inpatient setting.

A patient-centered framework for health systems engineering in gastroenterology: improving inpatient colonoscopy bowel preparation.

BACKGROUND: Inpatient colonoscopy bowel preparation (ICBP) is frequently inadequate and can lead to adverse events, delayed or repeated procedures, and negative patient outcomes. Guidelines to overcome the complex factors in this setting are not well established. Our aims were to use health systems engineering principles to comprehensively evaluate the ICBP process, create an ICBP protocol, increase adequate ICBP, and decrease length of stay. Our goal was to provide adaptable tools for other institutions and procedural specialties. METHODS: Patients admitted to our tertiary care academic hospital that underwent inpatient colonoscopy between July 3, 2017 to June 8, 2018 were included. Our multi-disciplinary team created a protocol employing health systems engineering techniques (i.e., process mapping, cause-effect diagrams, and plan-do-study-act cycles). We collected demographic and colonoscopy data. Our outcome measures were adequate preparation and length of stay. We compared pre-intervention (120 ICBP) vs. post-intervention (129 ICBP) outcomes using generalized linear regression models. Our new ICBP protocol included: split-dose 6-L polyethylene glycol-electrolyte solution, a gastroenterology electronic note template, and an education plan for patients, nurses, and physicians. RESULTS: The percent of adequate ICBPs significantly increased with the intervention from 61% pre-intervention to 74% post-intervention (adjusted odds ratio of 1.87, p value = 0.023). The median length of stay decreased by approximately 25%, from 4 days pre-intervention to 3 days post-intervention (p value = 0.11). CONCLUSIONS: By addressing issues at patient, provider, and system levels with health systems engineering principles, we addressed patient safety and quality of care provided by improving rates of adequate ICBP.

Who's that SMARTgirl? Reaching Cambodian Female Entertainment and Sex Workers with HIV Prevention Services.

Engagement in prevention services is crucial to reducing HIV risk among female entertainment and sex workers (FESW), and SMARTgirl is the national social marketing HIV prevention program for Cambodian women engaged in sex and entertainment work. Informed by the Behavioral Model of Vulnerable Populations, three multivariate logistic regression analyses examined correlates of three indices of engagement along the SMARTgirl HIV prevention continuum: (1) receipt of outreach services (past 3 months); (2) being registered as a SMARTgirl member; and (3) SMARTgirl club attendance (past year). Among the 1077 FESW enrolled in nine Cambodian provinces, women working in a brothel or freelance (adjusted odds ratio [aOR] 2.48; 95% CI 1.44-4.26) and those exchanging sex for drugs during the past 3 months (aOR 0.45; 95% CI 0.25-0.81) had significantly lower odds of contact with a SMARTgirl outreach worker. Women who reported having more than ten sexual partners in the past 3 months (aOR 0.54; 95% CI 0.32-0.89) and those who reported binge alcohol use (aOR 0.53; 95% CI 0.29-0.98) had significantly lower odds of being registered as SMARTgirl members. Exchanging sex for drugs was also associated with increased odds of attending a SMARTgirl club (aOR 2.03; 95% CI 1.04-3.98). Novel methods to deliver HIV prevention services are warranted to more effectively reach FESW who exchange sex for drugs, engage in binge alcohol use, report a greater number of sexual partners, and those not working in established work venues.

Syndemic Psychosocial Health Conditions Associated with Recent Client-Perpetrated Violence Against Female Entertainment and Sex Workers in Cambodia.

Female entertainment and sex workers (FESW) are vulnerable to violence, which impedes safer sex behaviors and increases risk of HIV. FESW are also disproportionately affected by co-occurring psychosocial health conditions, including substance use, depression, and economic insecurity, which increased risk of exposure to violence. We used a syndemic framework to examine the effects of co-occurring psychosocial conditions on the risk of client-perpetrated physical and sexual violence against FESW. Data were collected among 1198 Cambodian FESW on recent client-perpetrated physical and sexual violence, and psychosocial conditions (psychological distress, alcohol consumption, amphetamine-type stimulant (ATS) use, debts, housing, and food insecurity). Bivariate and multivariate logistic regressions were conducted. Prevalence of physical and sexual violence from clients was 4.8% and 6.9%, respectively. Client-perpetrated physical violence was associated with housing insecurity, ATS use, and psychological distress. All psychosocial conditions, except ATS, were associated with exposure to sexual violence. In multivariable models, odds of client-perpetrated physical violence were twice higher among women with ≥ 4 compared to ≤ 3 psychosocial conditions. Risk of sexual violence increased with the number of psychosocial conditions. Compared to those with ≤ 1 condition, FESW with two psychosocial conditions had twice the odds (AOR = 2.08; 95% CI 1.00-4.31) and women with 5-6 psychosocial conditions had eightfold higher odds (AOR = 8.10; 95% CI 3.4-19.31) of sexual violence from clients. Our findings support a syndemic model of co-occurring psychosocial conditions among FESW that are associated with increased risk of violence. Violence prevention interventions targeting FESW should adopt comprehensive approaches that address co-occurring psychosocial conditions.

Aprepitant Has Mixed Effects on Nausea and Reduces Other Symptoms in Patients With Gastroparesis and Related Disorders.

BACKGROUND & AIMS: There are few effective treatments for nausea and other symptoms in patients with gastroparesis and related syndromes. We performed a randomized trial of the ability of the neurokinin-1 receptor antagonist aprepitant to reduce symptoms in patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome. METHODS: We conducted a 4-week multicenter, double-masked trial of 126 patients with at least moderate symptoms of chronic nausea and vomiting of presumed gastric origin for a minimum of 6 months. Patients were randomly assigned to groups given oral aprepitant (125 mg/day, n = 63) or placebo (n = 63). The primary outcome from the intention-to-treat analysis was reduction in nausea, defined as a decrease of 25 mm or more, or absolute level below 25 mm, on a daily patient-reported 0-to-100 visual analog scale (VAS) of nausea severity. We calculated relative risks of nausea improvement using stratified Cochran-Mental-Haenszel analysis. RESULTS: Aprepitant did not reduce symptoms of nausea, based on the primary outcome measure (46% reduction in the VAS score in the aprepitant group vs 40% reduction in the placebo group; relative risk, 1.2; 95% CI, 0.8-1.7) (P = .43). However, patients in the aprepitant group had significant changes in secondary outcomes such as reduction in symptom severity (measured by the 0-5 Gastroparesis Clinical Symptom Index) for nausea (1.8 vs 1.0; P = .005), vomiting (1.6 vs 0.5; P = .001), and overall symptoms (1.3 vs 0.7; P = .001). Adverse events, predominantly mild or moderate in severity grade, were more common in aprepitant (22 of 63 patients, 35% vs 11 of 63, 17% in the placebo group) (P = .04). CONCLUSIONS: In a randomized trial of patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome, aprepitant did not reduce the severity of nausea when reduction in VAS score was used as the primary outcome. However, aprepitant had varying effects on secondary outcomes of symptom improvement. These findings support the need to identify appropriate patient outcomes for trials of therapies for gastroparesis, including potential additional trials for aprepitant. ClinicalTrials.gov no: NCT01149369.

Poor Health Literacy and Medication Burden Are Significant Predictors for Inadequate Bowel Preparation in an Urban Tertiary Care Setting.

GOALS: The goal of this study was to identify factors impacting the quality of bowel preparation in an urban tertiary care setting. BACKGROUND: Inadequate bowel preparation is encountered in 17% to 32% of colonoscopies performed in the United States. Suboptimal colonic visualization reduces the yield of screening colonoscopies and increases healthcare costs because of longer procedure times and aborted procedures. STUDY: We performed a cross-sectional survey in patients undergoing outpatient colonoscopy within the Johns Hopkins Health System. A Boston Bowel Preparation Score (BBPS) score of <5 was considered inadequate. Fisher's exact, χ tests and univariate and multivariate binary logistic regression were performed to assess the strength of the association for selected factors with a BBPS<5. RESULTS: In total, 467 patients (76.3% response rate) completed the survey between August 2017 and October 2017. The median BBPS score was 7, and 81.4% of patients had an adequate bowel preparation (BBPS≥5). There was significant association between bowel preparation adequacy and level of education, health literacy, functional status, income, and medication burden. When adjusted for other factors, poor confidence in filling forms (OR, 24.1; P<0.001), multiple daily prescription medications (OR, 12.49; P=0.02) and poor functional status (OR, 2.82; P=0.03) had the highest odds of predicting inadequate bowel preparation. CONCLUSIONS: Inadequate bowel preparation is a significant problem accounting for reduced yield of screening and increased health care costs. Poor health literacy, functional status, and number of daily medications are significant factors predicting inadequate bowel preparation in the tertiary care setting.

Roles of High-resolution Manometry in Predicting Incomplete Bolus Transit in Patients With Dysphagia.

BACKGROUND: High-resolution manometry (HRM) is used to assess esophageal motility diseases. Abnormalities in a number of HRM parameters have been reported in patients with dysphagia. However, it is unclear whether some of abnormal HRM parameters are predictive of dysphagia. The aim of this retrospective study was to investigate the roles of HRM parameters in predicting incomplete bolus clearance (IBC) in patients with dysphagia using high-resolution impedance manometry. METHODS: A total of 644 wet swallows were reviewed and analyzed in 63 patients with symptoms of dysphagia or reflux who underwent a clinical high-resolution impedance manometry test. IBC was defined based on impedance measurement. The relationship of each of abnormal HRM parameters with IBC was analyzed and their roles in predicting IBC were determined. RESULTS: Patients with symptoms of both dysphagia and reflux showed the highest IBC rate, and patients with symptoms of reflux had the lowest IBC rate. The IBC was more prevalent in the distal esophagus. Premature contractions and peristalsis with large breaks were associated with a higher IBC rate in the proximal esophagus (P<0.05); large breaks, ineffective peristalsis, and abnormalities of the esophageal gastric junction functions were associate with higher IBC rates in the distal esophagus (P<0.05). Abnormalities in a number of motility parameters were able to predict IBC with high specificities and/or high sensitivity, such as pan esophageal pressurization, ineffective peristalsis, and large breaks. Abnormal integrative relaxation pressure of the lower esophageal sphincter with concurrent pan esophageal pressurization, ineffective peristalsis, or large breaks is predictive of IBC with nearly 100% of specificity. CONCLUSIONS: Abnormalities in a number of HRM parameters are not only useful in diagnosing esophageal motility diseases, but also valuable in predicting IBC during swallowing.

High pregnancy incidence and low contraceptive use among a prospective cohort of female entertainment and sex workers in Phnom Penh, Cambodia.

BACKGROUND: While HIV and unintended pregnancies are both occupational risks faced by female sex workers, the epidemiology of pregnancy and its drivers in this population remains understudied. This includes Cambodia, where the drivers of pregnancy among female entertainment and sex workers (FESW) remain unknown. The current study aimed to examine factors associated with incident pregnancy, as well as describe contraceptive use among FESW in Phnom Penh, Cambodia. METHODS: This analysis drew from the Young Women's Health Study (YWHS)-2, a 12-month observational cohort of 220 FESW aged 15-29 years, conducted between August 2009 and August 2010. Interviewer-administered questionnaires were conducted at baseline and quarterly thereafter, alongside HIV and pregnancy testing. Bivariate and multivariable extended Cox regression analysis was used to examine correlates of incident pregnancy. RESULTS: At baseline, 6.8% of participants were pregnant, and only 10.8% reported using hormonal contraceptives, with 11.3% reporting an abortion in the past 3 months. Pregnancy incidence was high, at 22/100 person-years (95% CI: 16.3-30.1). In multivariable analysis, younger age (19-24 years versus 25-29 years) (Adjusted Hazards Ratio (AHR): 2.28; 95% Confidence Interval (CI) 1.22-4.27), lower income (400,000-600,000 Riel (≤150$USD) versus > 600,000 Riel (> 150$USD)) (AHR 2.63; 95% CI 1.02-6.77) positively predicted pregnancy, while higher self-reported condom self-efficacy were associated with reduced pregnancy incidence (AHR 0.89; 95% CI 0.81-0.98). CONCLUSIONS: Results document high incidence of pregnancy and unmet reproductive health needs among FESWs in Cambodia. Findings point to an urgent need for multi-level interventions, including venue-based HIV/STI and violence prevention interventions, in the context of legal and policy reform. High pregnancy incidence in this population may also undermine recruitment and retention into HIV prevention intervention trials. The exploration of innovative and comprehensive sex worker-tailored sexual and reproductive health service models, also as part of HIV prevention intervention trials, is warranted.

Prevalence and predictors of pain and opioid analgesic use following total pancreatectomy with islet autotransplantation for pancreatitis.

BACKGROUND & OBJECTIVES: Total pancreatectomy with islet autotransplantation (TPIAT) is employed for the management of refractory pain in chronic pancreatitis (CP) with the prospect of partial beta cell preservation. The primary aim of this study is to evaluate the prevalence and predictors of abdominal pain and opioid use following TPIAT. METHODS: A single center cohort study of all adult patients who underwent TPIAT from 2011 to 2015 for CP. Postoperative pain outcomes included: opioid use, ongoing abdominal pain and new characteristic abdominal pain. Multiple logistic regression analysis was used to evaluate known and potential predictors of postoperative pain outcomes. RESULTS: During the study period, 46 patients underwent TPIAT. Following surgery, 89% of patients had resolution of their pre-operative abdominal pain; however, 83% of patients developed a new characteristic abdominal pain. Opioid independence was achieved in 46% of patients. Acute recurrent pancreatitis (ARP) (OR: 11.66; 95%CI: 1.47-92.39; p = 0.02) but not pain duration >3 years or ≥ 5 ERCPs was independently associated with resolution of pre-operative abdominal pain on multiple logistic regression. None of these factors were associated with cessation of opioid use. CONCLUSION: While the majority of patients have resolution of their initial abdominal pain following TPIAT, many will also develop a new characteristic abdominal pain and only half of all patients achieve opioid independence. ARP is the only independent factor associated with positive postoperative pain outcomes and should be considered a standard criterion for patient selection.

Three-Dimensional Anorectal Manometry Enhances Diagnostic Gain by Detecting Sphincter Defects and Puborectalis Pressure.

BACKGROUND: Constipation and fecal incontinence (FI) are common and are often evaluated with anorectal manometry. Three-dimensional high-resolution anorectal manometry (HRAM) is a promising technology; however, implementation has been limited by lack of metrics and unclear clinical utility. AIM: To investigate the diagnostic utility of 3D HRAM compared to 2D HRAM. METHODS: Three-dimensional HRAM studies performed from April 2012 to October 2013 were identified and re-interpreted by two blinded investigators examining 3D function. Disagreements were resolved by a third investigator. Puborectalis (PR) visualization, focal defects, and dyssynergy were reported. Differences between groups were analyzed with Fisher's exact test. Discordance was analyzed with McNemar Chi-square test. RESULTS: Two hundred and twenty-one 3D HRAM studies were identified. Mean age and BMI were 52.2 ± 17.4 and 27.1 ± 7.5 years (81% female, 74% white). Most common indications for 3D HRAM were constipation (65%) and FI (28%). PR function was visualized in 81% (rest), 97% (squeeze), and 73% (strain). PR was visualized less often at rest in FI than constipation (68 vs. 85%, p = 0.007). Defects were identified twice as often in FI than constipation (19 vs. 10%, p = 0.113). Twenty-nine defects (86% anterior) were visualized on 3D HRAM. Inter-reader agreement was moderate for PR function (κ = 0.471), but fair for focal defects (κ = 0.304). CONCLUSIONS: PR function and focal defects can be visualized on 3D-HRAM with added diagnostic benefit compared to 2D. Fair inter-reader agreement for focal defects highlights the need for quantitative metrics.

Microbiota organization is a distinct feature of proximal colorectal cancers.

Environmental factors clearly affect colorectal cancer (CRC) incidence, but the mechanisms through which these factors function are unknown. One prime candidate is an altered colonic microbiota. Here we show that the mucosal microbiota organization is a critical factor associated with a subset of CRC. We identified invasive polymicrobial bacterial biofilms (bacterial aggregates), structures previously associated with nonmalignant intestinal pathology, nearly universally (89%) on right-sided tumors (13 of 15 CRCs, 4 of 4 adenomas) but on only 12% of left-sided tumors (2 of 15 CRCs, 0 of 2 adenomas). Surprisingly, patients with biofilm-positive tumors, whether cancers or adenomas, all had biofilms on their tumor-free mucosa far distant from their tumors. Bacterial biofilms were associated with diminished colonic epithelial cell E-cadherin and enhanced epithelial cell IL-6 and Stat3 activation, as well as increased crypt epithelial cell proliferation in normal colon mucosa. High-throughput sequencing revealed no consistent bacterial genus associated with tumors, regardless of biofilm status. However, principal coordinates analysis revealed that biofilm communities on paired normal mucosa, distant from the tumor itself, cluster with tumor microbiomes as opposed to biofilm-negative normal mucosa bacterial communities also from the tumor host. Colon mucosal biofilm detection may predict increased risk for development of sporadic CRC.

Ileus is a predictor of local infection in patients with acute necrotizing pancreatitis.

BACKGROUND & OBJECTIVES: Infected pancreatic necrosis (IPN) is associated with increased morbidity and mortality. Gut barrier dysfunction has been shown to increase the risk of bacterial translocation from the gut into the pancreatic bed. The primary aim of the study is to evaluate if ileus, a clinical marker of gut barrier dysfunction, can predict the development of IPN. METHODS: A retrospective cohort study of patients with necrotizing pancreatitis (NP) was conducted from 2000 to 2014. Ileus was defined as ≥2 of the following criteria: nausea/vomiting; inability to tolerate a diet, absence of flatus, abdominal distension and features of ileus on imaging. Extensive necrosis was defined as >30% nonenhancing pancreatic parenchyma on contrast-enhanced CT. Multivariable cox proportional hazard analysis was used to evaluate known and potential predictors of IPN. RESULTS: 142 patients were identified with NP, 61 with IPN and 81 with sterile necrosis. In comparison to a diagnosis of ileus documented in the medical chart, the ileus criteria had a sensitivity, specificity and positive and negative predictive value of 100%, 93%, 78% and 100%, respectively. On multivariate cox proportional hazard analysis, ileus [HR:2.6; 95%CI:1.4-4.9] and extensive necrosis [HR:2.8; 95%CI:1.3-5.8] were independently associated with the development of IPN while there was no association with bacteremia [HR:1.09; 95%CI:0.6-2.1]. CONCLUSION: Ileus in NP can be accurately defined using surgical criteria. Ileus is independently associated with the future development of IPN. Further studies will be needed to determine if ileus can serve as a clinical marker to direct therapeutic interventions aimed at reducing the incidence of IPN.

Comprehensive analysis of efficacy and safety of peroral endoscopic myotomy performed by a gastroenterologist in the endoscopy unit: a single-center experience.

BACKGROUND AND AIMS: The safety and efficacy of peroral endoscopic myotomy (POEM) when performed by gastroenterologists in the endoscopy unit are currently unknown. The aims of this study were to assess (1) the safety and efficacy of POEM in which all procedures were performed by 1 gastroenterologist in the endoscopy unit, and (2) the predictors of adverse events and nonresponse. METHODS: All consecutive patients who underwent POEM at 1 tertiary center were included. Clinical response was defined by a decrease in the Eckardt score to 3 or lower. Adverse events were graded according to the American Society for Gastrointestinal Endoscopy lexicon's severity grading system. RESULTS: A total of 60 consecutive patients underwent POEM in the endoscopy suite with a mean procedure length of 99 minutes. The mean length of submucosal tunnel was 14 cm and the mean myotomy length was 11 cm. The median length of hospital stay was 1 day. Among 52 patients with a mean follow-up period of 118 days (range 30-750), clinical response was observed in 48 patients (92.3%). There was a significant decrease in Eckardt score after POEM (8 vs 1.19, P < .0001). The mean lower esophageal sphincter pressure decreased significantly after POEM (29 mm Hg vs 11 mm Hg, P < .0001). A total of 10 adverse events occurred in 10 patients (16.7%): 7 rated as mild, 3 as moderate, and none as severe. Procedure length was the only predictor of adverse events (P = .01). pH impedance testing was completed in 25 patients, and 22 (88%) had abnormal acid exposure, but positive symptom correlation was present in only 6 patients. All patients with symptomatic reflux were successfully treated with proton pump inhibitors. CONCLUSIONS: POEM can be effectively and safely performed by experienced gastroenterologists at a tertiary care endoscopy unit. Adverse events are infrequent, and most can be managed intraprocedurally. Post-POEM reflux is frequent but can be successfully managed medically.

Evaluation of Kenya's readiness to transition from sentinel surveillance to routine HIV testing for antenatal clinic-based HIV surveillance.

BACKGROUND: Sentinel surveillance for HIV among women attending antenatal clinics using unlinked anonymous testing is a cornerstone of HIV surveillance in sub-Saharan Africa. Increased use of routine antenatal HIV testing allows consideration of using these programmatic data rather than sentinel surveillance data for HIV surveillance. METHODS: To gauge Kenya's readiness to discontinue sentinel surveillance, we evaluated whether recommended World Health Organization standards were fulfilled by conducting data and administrative reviews of antenatal clinics that offered both routine testing and sentinel surveillance in 2010. RESULTS: The proportion of tests that were HIV-positive among women aged 15-49 years was 6.2% (95% confidence interval [CI] 4.6-7.7%] in sentinel surveillance and 6.5% (95% CI 5.1-8.0%) in routine testing. The agreement of HIV test results between sentinel surveillance and routine testing was 98.0%, but 24.1% of specimens that tested positive in sentinel surveillance were recorded as negative in routine testing. Data completeness was moderate, with HIV test results recorded for 87.8% of women who received routine testing. CONCLUSIONS: Additional preparation is required before routine antenatal HIV testing data can supplant sentinel surveillance in Kenya. As the quality of program data has markedly improved since 2010 a repeat evaluation of the use of routine antenatal HIV testing data in lieu of ANC sentinel surveillance is recommended.

Intraoperative measurement of esophagogastric junction cross-sectional area by impedance planimetry correlates with clinical outcomes of peroral endoscopic myotomy for achalasia: a multicenter study.

BACKGROUND: Peroral endoscopic myotomy (POEM) has been introduced as an endoscopic alternative to surgical myotomy. The endoluminal functional lumen imaging probe (endoFLIP) evaluates esophagogastric junction (EGJ) distensibility based on cross-sectional area and pressure in response to volume distension. The aim of this study was to evaluate whether there is a correlation between endoFLIP measurements during POEM and postoperative clinical outcomes in terms of symptom relief and development of post-procedure reflux. METHODS: We conducted a retrospective review of achalasia patients who underwent POEM and intraoperative endoFLIP at three tertiary centers. Patients were divided into two groups based on clinical response measured by Eckardt score (ES): good response (ES < 3) or poor response (ES ≥ 3). Post-procedure reflux was defined as the presence of esophagitis and/or abnormal pH study. EGJ diameter, cross-sectional area, and distensibility measured by endoFLIP were compared. RESULTS: Of the 63 treated patients, 50 had good and 13 had poor clinical response. The intraoperative final EGJ cross-sectional area was significantly higher in the good-response group versus poor-response group; median (interquartile range): 89.0 (78.5-106.7) versus 72.4 (48.8-80.0) mm(2) [p = 0.01]. The final EGJ cross-sectional area was also significantly higher in patients who had reflux esophagitis after POEM: 99.5 (91.2-103.7) versus 79.3 (57.1-94.2) mm(2) [p = 0.02]. CONCLUSION: Intraoperative EGJ cross-sectional area during POEM for achalasia correlated with clinical response and post-procedure reflux. Impedance planimetry is a potentially important tool to guide the extent and adequacy of myotomy during POEM.