Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial.

BACKGROUND AND AIMS: The optimal type of stent for the palliation of malignant biliary obstruction in patients with pancreatic adenocarcinoma undergoing neoadjuvant chemoradiotherapy with curative intent is unknown. We performed a prospective trial comparing 3 types of biliary stents-fully covered self-expandable metal (fcSEMS), uncovered self-expandable metal (uSEMS), and plastic-to determine which best optimized cost-effectiveness and important clinical outcomes. METHODS: In this prospective randomized trial, consecutive patients with malignant biliary obstruction from newly diagnosed pancreatic adenocarcinoma who were to start neoadjuvant chemoradiotherapy were randomized to receive fcSEMSs, uSEMSs, or plastic stents during the index ERCP. The primary outcomes were time to stent occlusion, attempted surgical resection, or death after the initiation of neoadjuvant therapy, and the secondary outcomes were total patient costs associated with the stent, including the index ERCP cost, downstream hospitalization cost due to stent occlusion, and the cost associated with procedural adverse event. RESULTS: Fifty-four patients were randomized and reached the primary end point: 16 in the fcSEMS group, 17 in the uSEMS group, and 21 in the plastic stent group. No baseline demographic or tumor characteristic differences were noted among the groups. The fcSEMSs had a longer time to stent occlusion compared with uSEMSs and plastic stents (220 vs 74 and 76 days, P < .01), although the groups had equivalent rates of stent occlusion, attempted surgical resection, and death. Although SEMS placement cost more during the index ERCP (uSEMS = $24,874 and fcSEMS = $22,729 vs plastic = $18,701; P < .01), they resulted in higher procedural AE costs per patient (uSEMS = $5522 and fcSEMS = $12,701 vs plastic = $0; P < .01). Conversely, plastic stents resulted in an $11,458 hospitalization cost per patient due to stent occlusion compared with $2301 for uSEMSs and $0 for fcSEMSs (P < .01). CONCLUSIONS: In a prospective trial comparing fcSEMSs, uSEMSs, and plastic stents for malignant biliary obstruction in patients undergoing neoadjuvant therapy with curative intent for pancreatic adenocarcinoma, no stent type was superior in optimizing cost-effectiveness, although fcSEMSs resulted in fewer days of neoadjuvant treatment delay and a longer time to stent occlusion. (Clincial trial registration number: NCT01038713.).

A quality improvement project significantly increased the vaccination rate for immunosuppressed patients with IBD.

BACKGROUND: Immunosuppressed patients with inflammatory bowel disease (IBD) are at risk for vaccine preventable illnesses. Our aim was to develop a quality improvement intervention to measure and improve the proportion of immunosuppressed IBD patients receiving recommended vaccinations. METHODS: Using a Plan-Do-Study-Act quality improvement model, a process was developed to improve the proportion of patients with immunosuppressed IBD receiving recommended vaccinations. A 1-page vaccine questionnaire was developed and distributed to consecutive patients being seen in the IBD clinic during influenza season. If recommended vaccines were due, patients were offered and given vaccines by a nurse at that visit. After a period of observation, a second Plan-Do-Study-Act was performed and processes were improved. Data were collected and analyzed using simple descriptive statistics, Pearson's chi-square, and analysis of means. RESULTS: Over a 10-week period, 184 patients were included in the intervention. Eighty-four of these patients (46%) were receiving immunosuppressant medications. Of these 84 patients, 45 (54%) had received an influenza vaccination in the previous year and 26 (31%) had received a pneumococcal vaccination within the previous 5 years. After the quality improvement intervention, the rate increased to 81% for influenza (P < 0.001) and 54% for pneumococcal vaccination (P < 0.001). An analysis of means confirms a significant change from the overall mean before and after the intervention. CONCLUSIONS: The vaccination rate for a high-risk IBD population was significantly improved using a quality improvement intervention. A similar approach can be taken for other processes associated with improved quality of care.

The diagnosis of gastroesophageal reflux disease.

BACKGROUND: Gastroesophageal reflux disease is a highly prevalent condition that imposes a significant economic impact on the US health care system. The utility of commonly used tests for the diagnosis of gastroesophageal reflux disease has not been adequately reviewed. METHODS: A comprehensive review of the literature was undertaken to provide an evidence-based approach to the diagnosis of gastroesophageal reflux disease. EMBASE (1980-December 2008), OVID MEDLINE, and PubMed, (1966-December 2008) were searched using "gastroesophageal reflux" and "adults" with other terms, including medications, diagnostic tests, symptoms, and epidemiologic terms. Studies were limited to human trials, English language, and full articles. RESULTS: Heartburn is a reasonably sensitive symptom for the diagnosis of gastroesophageal reflux disease, although it does not reliably predict esophagitis. Standardized questionnaires have limited specificity, whereas the double-contrast barium swallow has a low sensitivity to diagnose gastroesophageal reflux. The role of esophageal manometry is limited to accurate placement of a pH-measuring device. pH testing has reasonable sensitivity and specificity for the diagnosis of gastroesophageal reflux disease. The sensitivity of upper endoscopy to diagnose gastroesophageal reflux is lower than that of pH tests. CONCLUSION: The diagnosis of gastroesophageal reflux disease remains difficult. In the absence of alarm symptoms, empiric treatment with acid suppression is warranted. pH testing provides valuable information in many patients, although the clinical utility of newer tests needs to be determined. Endoscopy should not be the first test used to diagnose gastroesophageal reflux.

Capnocytophaga canimorsus meningitis after routine myelography: a sentinel event identifies multiple opportunities for improvement of standard practices in radiology.

Meningitis developed after a routine myelogram in a healthy patient. When Capnocytophaga canimorsus was identified, investigations revealed that the patient, the radiologist, and the staff were all dog owners. Multiple deviations from recommended practices in radiology were identified and corrected. The investigation of an unusual sentinel event allowed multiple interventions to be implemented simultaneously, with resultant risk reduction for subsequent radiologic procedures.

Fragile X mental retardation protein is necessary for neurotransmitter-activated protein translation at synapses.

Fragile X mental retardation is caused by absence of the RNA-binding protein fragile X mental retardation protein (FMRP), encoded by the FMR1 gene. There is increasing evidence that FMRP regulates transport and modulates translation of some mRNAs. We studied neurotransmitter-activated synaptic protein synthesis in fmr1-knockout mice. Synaptoneurosomes from knockout mice did not manifest accelerated polyribosome assembly or protein synthesis as it occurs in wild-type mice upon stimulation of group I metabotropic glutamate receptors. Direct activation of protein kinase C did not compensate in the knockout mouse, indicating that the FMRP-dependent step is further along the signaling pathway. Visual cortices of young knockout mice exhibited a lower proportion of dendritic spine synapses containing polyribosomes than did the cortices of wild-type mice, corroborating this finding in vivo. This deficit in rapid neurotransmitter-controlled local translation of specific proteins may contribute to morphological and functional abnormalities observed in patients with fragile X syndrome.