A nurse practitioner model of care in the era of direct acting antiviral therapy for hepatitis C virus infection.

BACKGROUND AND AIM: Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection has resulted in high rates of successful disease cure; however, not enough healthcare providers are available to deliver treatment to the population living with chronic HCV. To demonstrate that a nurse practitioner (NP) model of care is non-inferior to specialist gastroenterologist (SG) management of HCV infection, as measured by sustained viral response at 12 weeks (SVR12) after initiation of DAA therapy. DESIGN: Retrospective cohort database study. SETTING: Single-center outpatient study, Central Coast Local Health District (CCLHD). PARTICIPANTS: All patients with chronic HCV treated in the CCLHD Liver Clinic in the period 3rd March 2016 to 31st May 2019 were retrospectively analyzed. In this time period, a total of 1638 patients with chronic HCV had completed treatment. Seven hundred and thirty-four patients were excluded (733 pre-PBS listing for DAAs and 1 not treated with DAA). Nine hundred and four patients were eligible for the study, of which 541 were managed by an SG, and 363 managed by an NP. MAIN OUTCOME MEASURES: Data were collected on patient demographics, genotype, fibrosis score, and presence of cirrhosis. Primary end point was number of patients achieving SVR12. RESULTS: Of the 904 patients treated with DAA, 764 (84.5%) achieved SVR12. There was no statistical difference (P > 0.05) in achieving SVR12 between patients treated by an SP (n = 481, 88.9%) and those treated by an NP (n = 281, 77.4%). CONCLUSION: An NP model of care is non-inferior to SG management of HCV infection, as evidenced by equivocal success in achieving SVR12 between the two treatment groups. Therefore, an NP model of care is a viable option in the era of DAA therapy for HCV infection. Ongoing investment into the delivery of NP care could increase treatment uptake of HCV, with the aim of decreasing overall burden of disease.

Prolonged treatment duration is required for successful Helicobacter pylori eradication with proton pump inhibitor triple therapy in Canada.

BACKGROUND: Traditional seven-day proton pump inhibitor triple therapy for Helicobacter pylori eradication has recently shown disappointing results outside of Canada. Prolonging therapy may be associated with poorer compliance and, hence, may not have a better outcome in a real-world setting. OBJECTIVE: To compare the outcomes of seven- and 14-day triple therapy for first-line treatment of H pylori infection in an effectiveness setting in Canada. METHODS: A total of 314 consecutive treatment-naive, adult H pylori-infected patients were allocated to either a seven- or 14-day triple therapy regimen, with a subgroup of 172 consecutive patients quasi-randomized to treatment according to date of visit. Eradication was confirmed using either urea breath test or gastric biopsies. Analysis was by intention to treat. RESULTS: Eradication was achieved in a higher proportion of patients who underwent 14-day versus seven-day treatment regimens (overall: 85% versus 70% [P≤0.001]; subgroup: 83% versus 64% [P≤0.01]). Although successful eradication was also associated with older age and a diagnosis of ulcer disease, multivariate analysis revealed only longer treatment duration and lack of yogurt ingestion as independent predictors of successful eradication. There was a trend toward reduced success in the latter years of the study. Side effects were similar in both groups and were not prevented by yogurt ingestion. CONCLUSIONS: The currently recommended duration of proton pump inhibitor triple therapy in Canada should be increased from seven to 14 days, the latter having achieved an excellent result in this particular real-world setting. Yogurt added no benefit. Further study is required to compare 10-day with 14-day treatment regimens.

Optimizing the multimodal approach to pancreatic cyst fluid diagnosis: developing a volume-based triage protocol.

BACKGROUND: The objective of this study was to develop a triage algorithm to optimize diagnostic yield from cytology, carcinoembryonic antigen (CEA), and v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) testing on different components of a single pancreatic cyst fluid specimen. The authors also sought to determine whether cell block supernatant was suitable for CEA and KRAS testing. METHODS: Fifty-four pancreatic cysts were triaged according to a volume-dependent protocol to generate fluid (neat and supernatant) and cell block specimens for cytology, comparative CEA, and KRAS testing. Follow-up histology, diagnostic cytology, or a combined clinicopathologic interpretation was recorded as the final diagnosis. RESULTS: There were 26 mucinous cystic lesions and 28 nonmucinous cystic lesions with volumes ranging from 0.3 mL to 55 mL. Testing different components of the specimens (cell block, neat, and/or supernatant) enabled all laboratory investigations to be performed on 50 of 54 cyst fluids (92.6%). Interpretive concordance was observed in 17 of 17 cases (100%) and in 35 of 40 cases (87.5%) that had multiple components tested for CEA and KRAS mutations, respectively. An elevated CEA level (>192 ng/mL) was the most sensitive test for the detection of a mucinous cystic lesion (62.5%) versus KRAS mutation (56%) and "positive" cytology (61.5%). KRAS mutations were identified in 2 of 25 mucinous cystic lesions (8%) in which cytology and CEA levels were not contributory. CONCLUSIONS: A volume-based protocol using different components of the specimen was able to optimize diagnostic yield in pancreatic cyst fluids. KRAS mutation testing increased diagnostic yield when combined with cytology and CEA analysis. The current results demonstrated that supernatant is comparable to neat fluid and cell block material for CEA and KRAS testing.

Prediction and prevention of upper gastrointestinal bleeding after cardiac surgery: a case control study.

BACKGROUND: Gastrointestinal (GI) complications of cardiovascular surgery, particularly bleeding, occur frequently. OBJECTIVE: To determine factors that predict upper GI bleeding (UGIB) after cardiac surgery to improve prognostication and, thus, outcomes. METHODS: The present case-control study reviewed institutional records spanning 2002 to 2005 for consecutive patients who developed in-hospital UGIB following cardiovascular surgery. Each case was matched to two to three controls for age, sex and date of hospital admission. Demographics, pharmacotherapy (including use of in-hospital acid suppression), endoscopic findings and outcomes were recorded. After adjustment for possible confounders, including Parsonnet score and demographic parameters, conditional logistic regression analysis identified independent significant predictors of the subsequent development of UGIB. RESULTS: The study population consisted of 131 cases (mean [± SD] age 68.8±10.2 years, 69.5% male, mean Parsonnet score 24.6±14.2) and 387 matched controls (mean age 68.8±10.8 years, 70.0% male, mean Parsonnet score 20.9±14.2). UGIB events occurred a mean of 10.3±7.7 days after cardiac surgery. Duration of mechanical ventilation (OR 3.01 [95% CI 1.44 to 6.28]), elevation of international normalized ratio (OR 1.91 [95% CI 1.31 to 2.78]) and occurrence of Clostridium difficile colitis before bleeding (OR 3.15 [95% CI 1.19 to 8.36]) were independent risk factors. Use of histamine type 2 receptor antagonists (H2RAs) (OR 0.65 [95% CI 0.38 to 1.12]) or proton pump inhibitors (PPIs) (OR 0.60 [95% CI 0.27 to 1.32]) demonstrated trends toward protecting against UGIB after cardiac surgery. CONCLUSIONS: GI bleeding events occurred approximately 10 days after cardiac surgery in patients with a complicated postoperative course. Significant predictors of subsequent bleeding included increased duration of mechanical ventilation and elevation of international normalized ratio; routine acid suppression with PPIs should be considered in such patients. C difficile colitis also significantly predicted UGIB, and H2RAs should be considered for acid suppression. Neither H2RAs nor PPIs were effective in preventing UGIB, although the small number of patients limits definitive conclusions regarding the role of acid suppression.

Cost-effectiveness of proton-pump inhibition before endoscopy in upper gastrointestinal bleeding.

BACKGROUND & AIMS: Randomized trials suggest high-dose proton-pump inhibitors (PPIs) administered before gastroscopy in suspected upper gastrointestinal bleeding downstage bleeding ulcer stigmata. We assessed the cost-effectiveness of this approach. METHODS: A decision model compared high-dose IVPPI initiated while awaiting endoscopy with IVPPI administration on the basis of endoscopic findings. IVPPIs were given to all patients undergoing endoscopic hemostasis for 72 hours thereafter. Once the IV regimen was completed or for patients with low-risk endoscopic lesions, an oral daily PPI was given for the remainder of the time horizon (30 days after endoscopy). The unit of effectiveness was the proportion of patients without rebleeding, representing the denominator of the cost-effectiveness ratio (cost per no rebleeding). Probabilities and costs were derived from the literature and national databases. RESULTS: IVPPIs before endoscopy were both slightly more costly and effective than after gastroscopy in the U.S. and Canadian settings, with cost-effectiveness ratios of US$5048 versus $4933 and CAN$6064 versus $6025 and incremental costs of US$45,673 and CAN$19,832 to prevent one additional rebleeding episode, respectively. Sensitivity analyses showed robust results in the US In Canada, intravenous proton-pump inhibitors (IVPPIs) before endoscopy became more effective and less costly (dominant strategy) when the uncomplicated stay for high-risk patients increased above 6 days or that of low-risk patients decreased below 3 days. CONCLUSIONS: With conservative estimates and high-quality data, IVPPIs given before endoscopy are slightly more effective and costly than no administration. In Canada, this approach becomes dominant as the duration of hospitalization for high-risk ulcer patients increases or that of low-risk ulcer patients decreases.