Diagnostic work-up and management of young patients with ulcer-like dyspepsia: A cost-minimisation study

Objective: We initiated a cost-minimisation modelling study to compare the costs of strategies based on initial endoscopy or initial non-invasive tests for the detection of Helicobacter (C13 UBT or serology) from the perspective of the Italian National Health Service. The secondary outcomes were the number of patients undergoing unnecessary Helicobacter pylori (HP) eradication treatment and the number of endoscopic examinations spared.Methods: The study was based on a decision analysis model referring to patients aged less than 45 years with ulcer-like dyspepsia and no alarming symptoms. The probabilities entered in the model were weighted means from published studies, and the costs were derived from the Italian NHS reimbursement schedule. Sensitivity analyses were conducted over a wide range of probability and cost estimates in order to test the robustness of the model.Results: Non-invasive tests (such as the preliminary work-up of patients with ulcer-like dyspepsia aged less than 45 years) were cheaper ..

Real-world data from the health decision maker perspective. What are we talking about?

Healthcare decision-makers are increasingly developing policies that seek information on “real-world” data providing “evidence” to support and monitor changes in clinical practice or policy decisions. Many strategies may be evaluated in experimental circumstances, but this does rarely reflect clinical practice. Due to the current focus on information and computer technology to provide safer and more efficient healthcare delivery, the amount of electronic medical records and other electronic healthcare data is increasing exponentially, and these real-world data can be used for evidence generation. This review describes why and how healthcare/policy decision making could benefit from real-world data, it introduces methods to investigate real-world clinical practice, lists potentialities of routinely collected real-world data, reviews their availability in the word, and outlines future challenges in this field

Influenza vaccines really work? Keeping apart the true from the false

A yearly seasonal flu vaccine is the best preventive method we have against influenza at this time. Even then, vaccination adoption is hampered by on-going discussions about safety and effectiveness. In order to dot the I's and cross the T's at the fifth ESWI influenza conference, a dedicated SPI track focused on these important aspects of influenza vaccination

The meaning of chakin placed on koita, as the evidence that temae has changed

textabstractIntroduction: There is growing interest in whether social media can capture patient-generated information relevant for medicines safety surveillance that cannot be found in traditional sources. Objective: The aim of this study was to evaluate the potential contribution of mining social media networks for medicines safety surveillance using the following associations as case studies: (1) rosiglitazone and cardiovascular events (i.e. stroke and myocardial infarction); and (2) human papilloma virus (HPV) vaccine and infertility. Methods: We collected publicly accessible, English-language posts on Facebook, Google+, and Twitter until September 2014. Data were queried for co-occurrence of keywords related to the drug/vaccine and event of interest within a post. Messages were analysed with respect to geographical distribution, context, linking to other web content, and author’s assertion regarding the supposed association. Results: A total of 2537 posts related to rosiglitazone/cardiovascular events and 2236 posts related to HPV vaccine/infertility were retrieved, with the majority of posts representing data from Twitter (98 and 85 %, respectively) and originating from users in the US. Approximately 21 % of rosiglitazone-related posts and 84 % of HPV vaccine-related posts referenced other web pages, mostly news items, law firms’ websites, or blogs. Assertion analysis predominantly showed affirmation of the association of rosiglitazone/cardiovascular events (72 %; n = 1821) and of HPV vaccine/infertility (79 %; n = 1758). Only ten posts described personal accounts of rosiglitazone/cardiovascular adverse event experiences, and nine posts described HPV vaccine problems related to infertility. Conclusions: Publicly available data from the considered social media networks were sparse and largely untrackable for the purpose of providing early clues of safety concerns regarding the prespecified case studies. Further research investigating other case studies and exploring other social media platforms are necessary to further characterise the usefulness of social media for safety surveillance

Descriptive analysis of postmarket surveillance data for hip implants

Purpose: Recent safety issues involving medical devices have highlighted the need for better postmarket surveillance (PMS) evaluation. This article aims to describe and to assess the quality of the PMS data for a medical device and, finally, to provide recommendations to improve the data gathering process. Methods: A descriptive analysis of medical device reports (MDRs) on the use of MRA, a specific type of hip implant replacement submitted to the Food and Drug Administration Manufacturer and User Facility Device Experience database from 1 January 2008 to 31 December 2017. The number of reports was described as the number of MDRs per unique MDR number and stratified by different variables. The quality was assessed by the level of completeness of the collected PMS data. Results: The total number of reports related to MRA was 2377, and the number of MDRs per year ranged between 84 in 2009 and 452 in 2017. Most of the reports were reported by manufacturer Depuy Johnson & Johnson and were reported by a physician. In 44.9% of the reports, the device problem was reported as “Unknown.” When the device problem was known, in the majority of cases, it was related to an implant fracture. The quality of the collected data was assessed as low due to missing information. Conclusion: The underlying data should meet high quality standards to generate more evidence and to ensure a timely signal generation. This case study shows that the completeness and quality of the MDRs can be improved. The authors propose the development of tools to ensure a more dynamic complaint data collection to contribute to this enhancement

Effectiveness of MF59™ Adjuvanted Influenza A(H1N1)pdm09 Vaccine in Risk Groups in the Netherlands

Background:The aim of the present study was to estimate the effectiveness of the MF59™-adjuvanted influenza A(H1N1)pdm09 vaccine against medically attended influenza-like illness and RT-PCR confirmed influenza in the at-risk population and persons over 60 in the Netherlands.Methods:We conducted a retrospective cohort study in a Dutch based GP medical record database between 30 November 2009 and 1 March 2010 to estimate the vaccine effectiveness against influenza-like illness. Within the cohort we nested a test negative case-control study to estimate the effectiveness against laboratory confirmed influenza.Results:The crude effectiveness in preventing diagnosed or possible influenza-like illness was 17.3% (95%CI: -8.5%-36.9%). Of the measured covariates, age, the severity of disease and health seeking behaviour through devised proxies confounded the association between vaccination and influenza-like illness. The adjusted vaccine effectiveness was 20.8% (95%CI: -5.4%, 40.5%) and varied significantly by age, being highest in adults up to 50 years (59%, 95%CI: 23%, 78%), and non-detectable in adults over 50 years. The number of cases in the nested case control study was too limited to validly estimate the VE against confirmed influenza.Conclusions:With our study we demonstrated that the approach of combining a cohort study in a primary health care database with field sampling is a feasible and useful option to monitor VE of influenza vaccines in the future

Alignment of vaccine codes using an ontology of vaccine descriptions

BACKGROUND: Vaccine information in European electronic health record (EHR) databases is represented using various clinical and database-specific coding systems and drug vocabularies. The lack of harmonization constitutes a challenge in reusing EHR data in collaborative benefit-risk studies about vaccines. METHODS: We designed an ontology of the properties that are commonly used in vaccine descriptions, called Ontology of Vaccine Descriptions (VaccO), with a dictionary for the analysis of multilingual vaccine descriptions. We implemented five algorithms for the alignment of vaccine coding systems, i.e., the identification of corresponding codes from different coding ystems, based on an analysis of the code descriptors. The algorithms were evaluated by comparing their results with manually created alignments in two reference sets including clinical and database-specific coding systems with multilingual code descriptors. RESULTS: The best-performing algorithm represented code descriptors as logical statements about entities in the VaccO ontology and used an ontology reasoner to infer common properties and identify corresponding vaccine codes. The evaluation demonstrated excellent performance of the approach (F-scores 0.91 and 0.96). CONCLUSION: The VaccO ontology allows the identification, representation, and comparison of heterogeneous descriptions of vaccines. The automatic alignment of vaccine coding systems can accelerate the readiness of EHR databases in collaborative vaccine studies

NSAIDs, statins, low-dose aspirin and PPIs, and the risk of oesophageal adenocarcinoma among patients with Barrett's oesophagus: A populationbased case-control study

Objectives: Non-steroidal anti-inflammatory drugs (NSAIDs), proton pump inhibitors (PPIs), low-dose aspirin and statins may decrease the risk of oesophageal adenocarcinoma (OAC) among patients with Barrett's oesophagus (BO). However, previous studies did not adequately address bias and confounding. Our objective was to estimate the risk of OAC among patients with BO exposed to NSAIDs, statins and PPIs. Design: Case-control study nested within a BO cohort. Setting: Two primary care databases (the UK and the Netherlands (NL)). Participants: Cases were adults ≥18 years of age with OAC or high-grade dysplasia (HGD) diagnosis ≥1 year after BO diagnosis. Controls were matched on age, sex, year of BO diagnosis and database. Exposure: Drug use was assessed from BO diagnosis until matching date. Outcome measure: Adjusted ORs with 95% CI were calculated by conditional logistic regression. Results: Within the BO cohort (n=15 134), 45 OAC (UK: 40, NL: 5) and 12 HGD cases (NL: 12) were identified. ORa for OAC during NSAID use was 1.2 (95% CI 0.6 to 2.5) and during statin use for <3 years 0.5 (95% CI 0.1 to 1.7). When including HGD cases (n=57), ORa for NSAID use was 0.9 (95% CI 0.5 to 1.8) and for statin use <3 years 0.5 (95% CI 0.1 to 1.7). Higher doses of statins showed lower estimates for OAC and HGD, though not statistically significant. Low-dose aspirin and PPIs did not significantly decrease the risk of OAC and HGD. Conclusions: In this population-based nested case- control study, use of NSAIDs, PPIs, low-dose aspirin or statins did not reduce the risk of HGD and OAC among patients with BO. These findings indicate that for an unselected group of patients with BO chemoprevention by use of drugs to reduce progression to HGD and OAC should not be directly considered as routine care