The combination of rectally administered indomethacin and placement of a prophylactic pancreatic stent is recommended to prevent pancreatitis after endoscopic retrograde cholangiopancreatography ...(ERCP) in high-risk patients. Preliminary evidence suggests that the use of indomethacin might eliminate or substantially reduce the need for stent placement, a technically complex, costly, and potentially harmful intervention.
In this randomised, non-inferiority trial conducted at 20 referral centres in the USA and Canada, patients (aged ≥18 years) at high risk for post-ERCP pancreatitis were randomly assigned (1:1) to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent. Patients, treating clinicians, and outcomes assessors were masked to study group assignment. The primary outcome was post-ERCP pancreatitis. To declare non-inferiority, the upper bound of the two-sided 95% CI for the difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) would have to be less than 5% (non-inferiority margin) in both the intention-to-treat and per-protocol populations. This trial is registered with ClinicalTrials.gov (NCT02476279), and is complete.
Between Sept 17, 2015, and Jan 25, 2023, a total of 1950 patients were randomly assigned. Post-ERCP pancreatitis occurred in 145 (14·9%) of 975 patients in the indomethacin alone group and in 110 (11·3%) of 975 in the indomethacin plus stent group (risk difference 3·6%; 95% CI 0·6–6·6; p=0·18 for non-inferiority). A post-hoc intention-to-treat analysis of the risk difference between groups showed that indomethacin alone was inferior to the combination of indomethacin plus prophylactic stent (p=0·011). The relative benefit of stent placement was generally consistent across study subgroups but appeared more prominent among patients at highest risk for pancreatitis. Safety outcomes (serious adverse events, intensive care unit admission, and hospital length of stay) did not differ between groups.
For preventing post-ERCP pancreatitis in high-risk patients, a strategy of indomethacin alone was not as effective as a strategy of indomethacin plus prophylactic pancreatic stent placement. These results support prophylactic pancreatic stent placement in addition to rectal indomethacin administration in high-risk patients, in accordance with clinical practice guidelines.
US National Institutes of Health.
A common metabolic alteration in the tumor microenvironment (TME) is lipid accumulation, a feature associated with immune dysfunction. Here we examined how CD8
+
tumor infiltrating lymphocytes (TILs) ...respond to lipids within the TME. We found elevated concentrations of several classes of lipids in the TME and accumulation of these in CD8
+
TILs. Lipid accumulation was associated with increased expression of CD36, a scavenger receptor for oxidized lipids, on CD8
+
TILs, which also correlated with progressive T cell dysfunction.
Cd36
−/−
T cells retained effector functions in the TME, as compared to WT counterparts. Mechanistically, CD36 promoted uptake of oxidized low-density lipoproteins (OxLDL) into T cells and this induced lipid peroxidation and downstream activation of p38 kinase. Inhibition of p38 restored effector T cell functions
in vitro
, and resolution of lipid peroxidation by over-expression of glutathione peroxidase 4 restored functionalities in CD8
+
TILs
in vivo
. Thus, an oxidized lipid-CD36 axis promotes intratumoral CD8 T cell dysfunction and serves as a therapeutic avenue for immunotherapies.
Lipid accumulation is a common metabolic alteration in the tumor microenvironment. Xu et al. show that intratumoral CD8
+
T cells adapt to increased lipid concentrations by increasing expression of the scavenger receptor CD36. This in turn leads to intracellular accumulation of oxidized lipid and T cell dysfunction downstream of lipid peroxidation.
Using the ongoing NIDDK-funded multicenter randomized clinical trial, Sphincterotomy for Acute Recurrent Pancreatitis (SHARP) as an example, this article discusses the rationale and key aspects of ...study design that need to be considered when conducting a clinical trial of endoscopic therapy in acute pancreatitis. SHARP, the first trial using a sham ERCP in the placebo group, is designed to address a decades long controversy in clinical pancreatology, i.e. whether minor papilla sphincterotomy benefits patients with idiopathic acute recurrent pancreatitis who also have pancreas divisum. Although the trial has already enrolled and randomized over 5 times the number of subjects enrolled in the only randomized trial in this area published in 1992 (107 vs. 19), recruitment has been challenging and we are at ∼46% of target recruitment. The review discusses the challenges in the execution of the trial and strategies the SHARP team has used to address these, which investigators planning or considering treatment trials in pancreatitis may find helpful. It will also inform the general gastroenterologists the importance of discussing and referring potentially eligible subjects to centers participating in clinical trials. Developing evidence-based treatment will provide a solid scientific basis for physicians to recommend evidence-based treatments for pancreatitis.
The advancement of technology seems to be prevalent and more economical for businesses. Business are adopting technology as a way of serving their customers. Those businesses that cannot keep up with ...technological advancement end up going out of business. To keep the progression of customer service, retailers must see the service as a benefit, and that the technology have impacted the interactions with customers and service staff. The problem of this study was to address the increasing technology in big-box chain stores and determine whether it is affecting customer service and customer relations. Research shows that customers’ feedback and social interaction are replaced by the kiosk and other self-service technology (SST); technology is replacing service representatives and diminishing social interaction. A qualitative research was the best option for this study due to the nature of the research questions; for investigating how customer service has change, due to the advancement of technology. A case study design was idea for this study because it produced a better understanding to the issues of individuals or groups, such as customers. Fourteen participants were sought for the study, five males and nine females, ranging from ages 30 to 70 years old. The participants were asked questions from the eight interview questions to help answer the research questions. Results of the study indicated that consumers want to be greeted, they want a friendly, pleasant shopping experience. They want a knowledgeable staff that can help them find what they are looking for. Based on the study results it is recommended that big-box chain stores provide a friendly, pleasant shopping experience for their customers, have more assistance at self-service check-outs, develop relationships with customers, have a knowledgeable staff available for questions about products and provide more assistance at the self-service check-out. Future research includes ways to provide adequate customer service in the wake of emerging technology and find ways to balance full-service and self-service that do not compromise personalized service from a sales associate.
Stimulus–stimulus pairing (SSP) is a procedure used by behavior analysis practitioners that capitalizes on respondent conditioning processes to elicit vocalizations. These procedures usually are ...implemented only after other, more customary methods (e.g., standard echoic training via modeling) have been exhausted. Unfortunately, SSP itself has mixed research support, probably because certain as-yet-unidentified procedural variations are more effective than others. Even when SSP produces (or increases) vocalizations, its effects can be short-lived. Although specific features of SSP differ across published accounts, fundamental characteristics include presentation of a vocal stimulus proximal with presentation of a preferred item. In the present article, we draw parallels between SSP procedures and autoshaping, review factors shown to affect autoshaping, and interpret autoshaping research for suggested SSP tests and applications. We then call for extended use and reporting of SSP in behavior-analytic treatments. Finally, three bridges created by this article are identified: basic-applied, respondent–operant, and behavior analysis with other sciences.
The combination of prophylactic pancreatic stent placement (PSP) - a temporary plastic stent placed in the pancreatic duct - and rectal non-steroidal anti-inflammatory drugs (NSAIDs) is recommended ...for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. Preliminary data, however, suggest that PSP may be unnecessary if rectal NSAIDs are administered. Given the costs and potential risks of PSP, we aim to determine whether rectal indomethacin obviates the need for pancreatic stent placement in patients undergoing high-risk ERCP.
The SVI (Stent vs. Indomethacin) trial is a comparative effectiveness, multicenter, randomized, double-blind, non-inferiority study of rectal indomethacin alone versus the combination of rectal indomethacin and PSP for preventing PEP in high-risk cases. One thousand four hundred and thirty subjects undergoing high-risk ERCP, in whom PSP is planned solely for PEP prevention, will be randomized to indomethacin alone or combination therapy. Those who are aware of study group assignment, including the endoscopist, will not be involved in the post-procedure care of the patient for at least 48 hours. Subjects will be assessed for PEP and its severity by a panel of independent and blinded adjudicators. Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups. Biological specimens will be obtained from trial participants and centrally banked.
The SVI trial is designed to determine whether PSP remains necessary in the era of NSAIDs pharmacoprevention. The associated bio-repository will establish the groundwork for important scientific breakthrough.
NCT02476279, registered June 2015.
Leaders have the responsibility of protecting organizations as entities and to protect those within the organization. Workplace bullying has become common place in organizations and its effects are ...far reaching. The phenomenon causes decreased productivity, absenteeism, employee turnover, and psychological harm. Leaders are struggling with ways to successfully handle the situation. The purpose of the study was to investigate a relationship between understanding workplace bullying behavior and a leader's emotional intelligence. The premise of the study utilized the social theories. The study hoped to illuminate a framework in which leaders become catalysts for change by learning to recognize the bad behavior and socializing the negative consequences throughout the organization. The quantitative research consisted of a survey to leaders in the United States (N=150). Each respondent first answered questions regarding bullying behavior to access knowledge of the subject. Then the participants rated themselves on emotional intelligence. A Pearson correlation test conducted on the bullying score and emotional intelligence mean did not find a statistically significant correlation between the variables or the sub-categories of emotional intelligence. The null hypothesis was accepted for the research question related to correlation, however, the null hypothesis was rejected for the second hypothesis because as bullying awareness increased so did emotional intelligence. The ramifications of the results continue to make a solution for workplace bullying elusive. There is no panacea fix for the issue. The topic of emotional intelligence as related to workplace bullying discernment has yet to be fully explored. Continued research using 360-degree feedback instead of self-ratings of Emotional Intelligence may provide differing results.
Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a significant and potentially life-threatening adverse event and is common in patients with suspected sphincter of Oddi ...dysfunction (SOD). Here we aimed to identify predictors of the risk in this population.
The Evaluating Predictors and Interventions in SOD (EPISOD) study prospectively enrolled 214 post-cholecystectomy patients with SOD type III in seven US centers. Patients were randomized, using a 2:1 allocation, to sphincterotomy or sham procedure, irrespective of the results of sphincter of Oddi manometry. Patients in the sphincterotomy arm who had elevated pancreatic sphincter pressure were randomized to biliary only or to dual (biliary and pancreatic) sphincterotomy. All but one patient received prophylactic pancreatic stents, but none received pharmacological prophylaxis. Post ERCP pancreatitis (PEP) was defined as acute pancreatitis within the subsequent 7 days. Blinded research coordinators at each site called patients at 1 week post-procedure.
PEP occurred in 26 patients, in 10.6 % (15/141) in the sphincterotomy arm and 15.1 % (11/73) in the sham arm; unadjusted relative risk 0.71 (95 % confidence interval 95 %CI 0.34 - 1.46). PEP rate was not significantly different in patients who received sphincterotomy compared with those undergoing sham treatment. In addition, the proportion was not statistically different in those who received biliary sphincterotomy alone (12/94; 12.8 % 95 %CI 6.0 % - 19.5 %) compared with dual sphincterotomy (3/47; 6.4 % 95 %CI 0.0 % - 13.4 %). Multivariate analysis identified an interaction between duration of ERCP and sedation type (P < 0.02).
The performance of biliary or dual sphincterotomy does not increase the risk of PEP in patients suspected of SOD. However, the high rate of PEP in patients with suspected SOD, despite pancreatic stenting in expert centers, is confirmed in this prospective study. The combined effect of duration of ERCP and sedation type on the development of PEP should be further explored.Clinicaltrials.gov registration: NCT00688662.
What is the extent to which marriage/couple and family therapy (M/CFT) journals address transgender issues and how many of them say they are inclusive of transgender persons when they are not? To ...answer these queries, a content analysis was conducted on articles published in M/CFT literature from 1997 through 2009. Of the 10,739 articles examined in 17 journals, only nine (0.0008%) focused on transgender issues or used gender variance as a variable. Findings support the assertion that transgender issues are ignored and marginalized by M/CFT scholars and researchers alike.
PDF
