Electronic Repositories Research Articles

Clinical Outcomes of the Oral Suspension vs Delayed-Release Tablet Formulations of Posaconazole for Prophylaxis of Invasive Fungal Infections

Background Posaconazole is effective prophylaxis for invasive fungal infections (IFIs). We compared incidence of breakthrough IFI (bIFI) and early posaconazole discontinuation between patients receiving delayed-release tablet and oral suspension formulations.Methods This was a retrospective cohort study of patients receiving posaconazole at Oregon Health & Science University Hospital between 1/1/2010 and 6/30/2016. Oral suspension was the preferred formulation until 2/2014; afterwards the tablet was preferred. We included all courses of primary prophylaxis for each patient during the study period. Data were extracted from an electronic health record repository and via chart review. Three independent reviewers identified bIFI using European Organization for Research and Treatment of Cancer criteria. We assessed rationale for early discontinuation of posaconazole for patients that were still indicated for antifungal prophylaxis based on National Comprehensive Cancer Network (NCCN) criteria.Results547 patients received 859 courses of posaconazole (53% oral suspension and 48% tablet). Prophylaxis was indicated according to NCCN criteria in 91% of courses. The primary indications for prophylaxis were acute myelogenous leukemia (68%), graft-vs-host disease (18%), and myelodysplastic syndrome (3%). There were no significant differences in demographics or indication between patients receiving the different formulations. The overall incidence rate of bIFI was 4.15/10,000 posaconazole-days (16 total bIFI events). Incidence of bIFI was not significantly different between patients receiving the different formulations (P = 0.92). Posaconazole was discontinued early in 147 (17%) courses; frequency of discontinuation was not significantly different between the tablet (20%) and oral suspension (15%) formulations (P = 0.10). The primary reasons for early discontinuation were elevated liver function tests or QT prolongation (25%), inability to take an oral formulation (17%), and drug cost (17%).Conclusion Among patients receiving posaconazole prophylaxis, incidence of bIFI was low and not significantly different between those receiving the tablet vs oral suspension formulations.Disclosures J. P. Furuno, Merck & Co.: Consultant and Grant Investigator, Consulting fee, Research grant and Speaker honorarium. J. S. Lewis II, Merck & Co.: Consultant, Consulting fee. J. C. McGregor, Merck & Co.: Grant Investigator, Research grant

LB994 Melanoma associated with systemic lupus erythematous

Systemic Lupus Erythematosus (SLE), as an autoimmune disorder with chronic inflammation, may enhance cellular dysplasia that may lead to uncontrolled tumor cell proliferation. Several meta-analyses of patients with SLE have shown an increased relative risk of Non-Hodgkin’s and Hodgkin’s lymphoma, as well as laryngeal, lung, liver, vaginal, vulvar, and thyroid malignancies, and even non-melanoma skin cancers, but the association between malignant melanoma (MM) and SLE remains unclear. The aim of this study is to determine if a relationship exists between MM and SLE in a large, urban, U.S. patient population by searching an electronic medical record data repository for dermatology or rheumatology patients aged 18-89 years with a diagnosis of SLE. A control population consisted of dermatology or rheumatology patients with a diagnosis of systemic sclerosis (SS). Incident MM was the outcome of interest using ICD-9 and 10 codes. Data for a total of 4,027 patients were evaluable (Jan 2001 through Dec 2016). Of the 2,351 patients who had a diagnosis of SLE, 10 (0.4%) were subsequently diagnosed with MM, while only 1 (0.06%) patient had a subsequent diagnosis of MM among 1,676 patients diagnosed with SS, yielding a statistically significant association between SLE and MM (Fisher’s exact test, p = 0.03). Of concern, evolving emphasis on the management of several malignant disorders, including MM, with checkpoint inhibitors (anti-CTLA-4 or anti-PD-1), carries the potential to aggressively disrupt immune reactivity and to potentially trigger uncontrolled cellular responses in patients with SLE. These findings in this large population warrant further exploration of the association between MM and SLE in order to promote more optimal patient management.

The Price of Ignorance: The Constitutional Cost of Fees for Access to Electronic Public Court Records

The U.S. Federal Judiciary maintains a system called PACER, “Public Access to Court Electronic Records.” PACER is the public gateway into the electronic repository for all documents filed in federal court. In lieu of appropriating funds for operating the system, Congress permitted the Judiciary to collect fees. Through the web, for a per-page fee, members of the public may access documents that have traditionally been part of the free public record. The fees have persisted for decades, even though Congress intended for the Judiciary to move away from user fees to a “structure in which this information is freely available to the greatest extent possible.” This paper argues that the Judiciary has erected a fee structure that forecloses essential democratic ends because the fees make public federal court records practically inaccessible. The per-page fee model inhibits constitutionally protected activities without promoting equally transcendent ends. Through this fee system, the Judiciary collects fees at ever-increasing rates and uses much of the revenue for entirely different purposes. In this era, the actual cost of storing and transmitting digital records approaches zero. Hence, PACER should be free. This paper examines the public’s interest in free electronic access to federal court records and considers the relative strength of legal and policy arguments to the contrary. Part I performs an accounting of the true costs of a free-access regime. Part II details the benefits of free electronic access to federal court records. Part III argues that, in the tradition of Richmond Newspapers, free access to electronic court records is a constitutionally necessary element of the structure of our modern Judiciary.

EXPLORAÇÃO DO ACERVO DA RAE-REVISTA DE ADMINISTRAÇÃO DE EMPRESAS (DE 1961 A 2016) À LUZ DA BIBLIOMETRIA, TEXT MINING, REDE SOCIAL E GEOANÁLISE

RESUMO Este artigo analisou mais de cinco décadas do acervo da Revista de Administração de Empresas (RAE), entre 1961 e 2016, pelo acesso aos documentos disponibilizados via internet no repositório eletrônico de periódicos e revistas da Biblioteca Digital da Fundação Getulio Vargas - Escola de Administração de Empresas de São Paulo, o qual segue o protocolo aberto Open Archives Initiative - Protocol for Metadata Harvesting (OAI-PMH) de interoperabilidade entre repositórios digitais. Um total de 2.381 documentos publicados no periódico (1.422 artigos, 217 editoriais, 62 pensatas e 680 resenhas) foi coletado de modo automatizado e posteriormente analisado com a utilização de técnicas de bibliometria, text mining, rede social e geoanálise. Este estudo permite compreender a trajetória da existência do periódico RAE em seus 22 diferentes períodos de gestão, o incremento da autoria nas publicações do periódico em 14 intervalos de tempo, os termos e palavras-chave com mais frequência e importância nos documentos publicados, bem como a formação das redes de coautoria dos pesquisadores que contribuíram para o desenvolvimento da ciência da Administração no País.

Knowledge reuse through electronic knowledge repositories: a multi theoretical study

PurposeThis study provides insight into factors surrounding knowledge reuse through electronic knowledge repositories (EKR).Design/methodology/approachA multi-theoretical framework is proposed that views knowledge reuse from both socio-technical and expectation confirmation model perspectives. Survey data are used to test associated hypotheses derived from the literature.FindingsResults confirm the explanatory power of this approach to predict greater knowledge reuse and greater continuance of use.Research limitations/implicationsResults suggest social and technical factors modelled interdependently affect knowledge reuse and lead to greater performance, knowledge sharing and continuance of use.Practical implicationsPractical and managerial recommendations for enhancing enablers of knowledge reuse via EKR are offered.Originality/valueThis study models enablers to knowledge reuse and resulting downstream effects on organizational outcomes. It provides an original framework for studying knowledge reuse within an EKR or knowledge management system perspective.

Validity of Cardiovascular Data From Electronic Sources

Understanding the validity of data from electronic data research networks is critical to national research initiatives and learning healthcare systems for cardiovascular care. Our goal was to evaluate the degree of agreement of electronic data research networks in comparison with data collected by standardized research approaches in a cohort study. We linked individual-level data from MESA (Multi-Ethnic Study of Atherosclerosis), a community-based cohort, with HealthLNK, a 2006 to 2012 database of electronic health records from 6 Chicago health systems. To evaluate the correlation and agreement of blood pressure in HealthLNK in comparison with in-person MESA examinations, and body mass index in HealthLNK in comparison with MESA, we used Pearson correlation coefficients and Bland-Altman plots. Using diagnoses in MESA as the criterion standard, we calculated the performance of HealthLNK for hypertension, obesity, and diabetes mellitus diagnosis by using International Classification of Diseases, Ninth Revision codes and clinical data. We also identified potential myocardial infarctions, strokes, and heart failure events in HealthLNK and compared them with adjudicated events in MESA. Of the 1164 MESA participants enrolled at the Chicago Field Center, 802 (68.9%) participants had data in HealthLNK. The correlation was low for systolic blood pressure (0.39; P<0.0001). In comparison with MESA, HealthLNK overestimated systolic blood pressure by 6.5 mm Hg (95% confidence interval, 4.2-7.8). There was a high correlation between body mass index in MESA and HealthLNK (0.94; P<0.0001). HealthLNK underestimated body mass index by 0.3 kg/m2 (95% confidence interval, -0.4 to -0.1). With the use of International Classification of Diseases, Ninth Revision codes and clinical data, the sensitivity and specificity of HealthLNK queries for hypertension were 82.4% and 59.4%, for obesity were 73.0% and 89.8%, and for diabetes mellitus were 79.8% and 93.3%. In comparison with adjudicated cardiovascular events in MESA, the concordance rates for myocardial infarction, stroke, and heart failure were, respectively, 41.7% (5/12), 61.5% (8/13), and 62.5% (10/16). These findings illustrate the limitations and strengths of electronic data repositories in comparison with information collected by traditional standardized epidemiological approaches for the ascertainment of cardiovascular risk factors and events.

Integrated Detection and Prediction of Influenza Activity for Real-Time Surveillance: Algorithm Design.

BackgroundInfluenza is a viral respiratory disease capable of causing epidemics that represent a threat to communities worldwide. The rapidly growing availability of electronic “big data” from diagnostic and prediagnostic sources in health care and public health settings permits advance of a new generation of methods for local detection and prediction of winter influenza seasons and influenza pandemics.ObjectiveThe aim of this study was to present a method for integrated detection and prediction of influenza virus activity in local settings using electronically available surveillance data and to evaluate its performance by retrospective application on authentic data from a Swedish county.MethodsAn integrated detection and prediction method was formally defined based on a design rationale for influenza detection and prediction methods adapted for local surveillance. The novel method was retrospectively applied on data from the winter influenza season 2008-09 in a Swedish county (population 445,000). Outcome data represented individuals who met a clinical case definition for influenza (based on International Classification of Diseases version 10 [ICD-10] codes) from an electronic health data repository. Information from calls to a telenursing service in the county was used as syndromic data source.ResultsThe novel integrated detection and prediction method is based on nonmechanistic statistical models and is designed for integration in local health information systems. The method is divided into separate modules for detection and prediction of local influenza virus activity. The function of the detection module is to alert for an upcoming period of increased load of influenza cases on local health care (using influenza-diagnosis data), whereas the function of the prediction module is to predict the timing of the activity peak (using syndromic data) and its intensity (using influenza-diagnosis data). For detection modeling, exponential regression was used based on the assumption that the beginning of a winter influenza season has an exponential growth of infected individuals. For prediction modeling, linear regression was applied on 7-day periods at the time in order to find the peak timing, whereas a derivate of a normal distribution density function was used to find the peak intensity. We found that the integrated detection and prediction method detected the 2008-09 winter influenza season on its starting day (optimal timeliness 0 days), whereas the predicted peak was estimated to occur 7 days ahead of the factual peak and the predicted peak intensity was estimated to be 26% lower than the factual intensity (6.3 compared with 8.5 influenza-diagnosis cases/100,000).ConclusionsOur detection and prediction method is one of the first integrated methods specifically designed for local application on influenza data electronically available for surveillance. The performance of the method in a retrospective study indicates that further prospective evaluations of the methods are justified.

Persistent erectile dysfunction in men exposed to the 5α-reductase inhibitors, finasteride, or dutasteride.

ImportanceCase reports describe persistent erectile dysfunction (PED) associated with exposure to 5α-reductase inhibitors (5α-RIs). Clinical trial reports and the manufacturers’ full prescribing information (FPI) for finasteride and dutasteride state that risk of sexual adverse effects is not increased by longer duration of 5α-RI exposure and that sexual adverse effects of 5α-RIs resolve in men who discontinue exposure.ObjectiveOur chief objective was to assess whether longer duration of 5α-RI exposure increases risk of PED, independent of age and other known risk factors. Men with shorter 5α-RI exposure served as a comparison control group for those with longer exposure.DesignWe used a single-group study design and classification tree analysis (CTA) to model PED (lasting ≥90 days after stopping 5α-RI). Covariates included subject attributes, diseases, and drug exposures associated with sexual dysfunction.SettingOur data source was the electronic medical record data repository for Northwestern Medicine.SubjectsThe analysis cohorts comprised all men exposed to finasteride or dutasteride or combination products containing one of these drugs, and the subgroup of men 16–42 years old and exposed to finasteride ≤1.25 mg/day.Main outcome and measuresOur main outcome measure was diagnosis of PED beginning after first 5α-RI exposure, continuing for at least 90 days after stopping 5α-RI, and with contemporaneous treatment with a phosphodiesterase-5 inhibitor (PDE5I). Other outcome measures were erectile dysfunction (ED) and low libido. PED was determined by manual review of medical narratives for all subjects with ED. Risk of an adverse effect was expressed as number needed to harm (NNH).ResultsAmong men with 5α-RI exposure, 167 of 11,909 (1.4%) developed PED (persistence median 1,348 days after stopping 5α-RI, interquartile range (IQR) 631.5–2320.5 days); the multivariable model predicting PED had four variables: prostate disease, duration of 5α-RI exposure, age, and nonsteroidal anti-inflammatory drug (NSAID) use. Of 530 men with new ED, 167 (31.5%) had new PED. Men without prostate disease who combined NSAID use with >208.5 days of 5α-RI exposure had 4.8-fold higher risk of PED than men with shorter exposure (NNH 59.8, all p < 0.002). Among men 16–42 years old and exposed to finasteride ≤1.25 mg/day, 34 of 4,284 (0.8%) developed PED (persistence median 1,534 days, IQR 651–2,351 days); the multivariable model predicting PED had one variable: duration of 5α-RI exposure. Of 103 young men with new ED, 34 (33%) had new PED. Young men with >205 days of finasteride exposure had 4.9-fold higher risk of PED (NNH 108.2, p < 0.004) than men with shorter exposure.Conclusion and relevanceRisk of PED was higher in men with longer exposure to 5α-RIs. Among young men, longer exposure to finasteride posed a greater risk of PED than all other assessed risk factors.

39: Changing referral patterns to urogynecology

To identify sources of and changes in referral patterns for pelvic floor disorders. After IRB approval, we used the Enterprise Data Warehouse, our institution’s electronic repository of electronic medical records, to identify all new patient visits (NPV) to urogynecology between January 2010 and December 2015. We excluded patients referred for obstetric injury or without documented referral source from analysis. Demographics, referral source, insurance type, and visit diagnoses using ICD-9 codes were abstracted. ICD-9 codes were grouped into 18 common urogynecologic diagnoses. Data were analyzed using SPSS. A total of 5799 NPV were included in the analysis. Women had mean age ± SD of 54 ± 17. 59% were white, 11% Black, 2% Hispanic, 2% Asian, and 25% did not provide their race. NPV increased by 280% over 6 years from 507 in 2010 to 1418 in 2015. Overall, 44% of patients were referred by obstetrician/gynecologists (OG), 32% by primary care providers (PCP), 14% by self-referral, and 9% by other subspecialties (Figure 1). Insurance plans were as follows: 43% Participating Provider Organization (PPO); 32% Medicare; 19% Health Maintenance Organization (HMO); and 6% Medicaid. The proportion of self and PCP referrals increased substantially by 480% and 320%, respectively. OG referrals increased by 229% over 6 years. Primary referral source differed by patient age with OG referring the majority of women <65 (50% OG vs 27% PC, P < 0.001) and PC referring the majority >65 (46% PC vs 30% OG, P < 0.001). Likewise, insurance type was associated with referral source. Patients with PPO and HMO were more likely to be referred by an OG than a PCP (32% vs 16%, p < 0.001) while patients with Medicare were more likely to be referred by a PCP than OG (14% vs 10%, p < 0.001). New patients diagnosed with pelvic organ prolapse and stress urinary incontinence were more likely to be referred by an OG (p < 0.001) while those with mixed incontinence, neurogenic bladder and hematuria, were equally likely to be referred by an OG (3%) as by a PCP (3%). PCPs were more likely to refer patients for urinary tract infections (p < 0.005) and for urgency urinary incontinence (p < 0.001) than OGs. This association remained significant (p = 0.03) when controlling for age and insurance status as women over 65 are more likely to have urgency incontinence, have Medicare and be referred by a PCP. Demand for pelvic floor services at our center exceeds prior predictions, increasing by 280% in the last 6-years. OGs account for less than half of referrals with PCP and self-referrals accounting for the greatest growth. This study emphasizes the importance of ongoing outreach to PCPs and OGs as well as to women directly.

Patient-Specific Predictive Modeling Using Random Forests: An Observational Study for the Critically Ill.

BackgroundWith a large-scale electronic health record repository, it is feasible to build a customized patient outcome prediction model specifically for a given patient. This approach involves identifying past patients who are similar to the present patient and using their data to train a personalized predictive model. Our previous work investigated a cosine-similarity patient similarity metric (PSM) for such patient-specific predictive modeling.ObjectiveThe objective of the study is to investigate the random forest (RF) proximity measure as a PSM in the context of personalized mortality prediction for intensive care unit (ICU) patients.MethodsA total of 17,152 ICU admissions were extracted from the Multiparameter Intelligent Monitoring in Intensive Care II database. A number of predictor variables were extracted from the first 24 hours in the ICU. Outcome to be predicted was 30-day mortality. A patient-specific predictive model was trained for each ICU admission using an RF PSM inspired by the RF proximity measure. Death counting, logistic regression, decision tree, and RF models were studied with a hard threshold applied to RF PSM values to only include the M most similar patients in model training, where M was varied. In addition, case-specific random forests (CSRFs), which uses RF proximity for weighted bootstrapping, were trained.ResultsCompared to our previous study that investigated a cosine similarity PSM, the RF PSM resulted in superior or comparable predictive performance. RF and CSRF exhibited the best performances (in terms of mean area under the receiver operating characteristic curve [95% confidence interval], RF: 0.839 [0.835-0.844]; CSRF: 0.832 [0.821-0.843]). RF and CSRF did not benefit from personalization via the use of the RF PSM, while the other models did.ConclusionsThe RF PSM led to good mortality prediction performance for several predictive models, although it failed to induce improved performance in RF and CSRF. The distinction between predictor and similarity variables is an important issue arising from the present study. RFs present a promising method for patient-specific outcome prediction.

Interaction of Ethnicity and H. pylori Infection in the Occurrence of Microscopic Colitis.

Previous studies found that microscopic colitis is inversely associated with Helicobacter pylori infection and that microscopic colitis is characterized by a marked ethnic variation. The aim of the present study was to test whether an underlying ethnic variation of H. pylori infection is responsible for the ethnic variation of microscopic colitis. The Miraca Life Sciences Database is a large national electronic repository of histopathologic records of patients distributed throughout the entire USA. A cross-sectional study evaluated the influence of age, gender, ethnicity, and histologic diagnosis of H. pylori on the occurrence of microscopic colitis among subjects who underwent esophago-gastro-duodenoscopies plus colonoscopy. The total study population comprised 228,506 subjects, of whom 28,890 carried a diagnosis of H. pylori gastritis and 3460 microscopic colitis. Female sex, old age, and H. pylori infection exerted the strongest influence on the occurrence of microscopic colitis. In comparison with the population comprising Caucasians and African-Americans, microscopic colitis was less common among subjects of Hispanic (0.34, 0.27-0.47), East Asian (0.13, 0.06-0.22), Indian (0.31, 0.10-0.73), or Middle Eastern descent (0.28, 0.07-0.74). All these ethnic subgroups were also characterized by a higher prevalence of H. pylori than the comparison group. A low prevalence of H. pylori was significantly associated with a high prevalence of microscopic colitis (R 2=0.91, p<0.001). Ethnic variations in the gastric infection with H. pylori may be partly responsible for the observed ethnic distribution of microscopic colitis.

Incidence and Outcomes of Cytomegalovirus (CMV) Infection among Hematopoietic Stem Cell Transplant (HSCT) Recipients

BackgroundOutcomes of CMV infection among HSCT recipients likely vary by patient population and treatment modality. However, data on these outcomes have been reported by relatively few centers.MethodsThis was a retrospective cohort study of allogenic HSCT recipients age ≥18 years at Oregon Health and Science University Hospital (OHSU) between 2010–2015. During the study period, OHSU standard practice was to preemptively treat CMV-viremic patients (quantitative PCR assay ≥ 200 copies/mL or consecutive PCR assays <200 copies/mL) with first-line valganciclovir or ganciclovir and second line foscarnet if there were contraindications to first-line agents. Study data were collected from an electronic health record repository and local Center for International Blood and Marrow Transplant Research (CIBMTR) database. Primary outcomes were clinical manifestations of CMV disease, death, and cause of death within 1 year of transplant.ResultsAmong 409 HSCT recipients, mean age was 53 (standard deviation: 13) years and 41% were female. 192 (47%) patients had CMV viremia and the median (interquartile range) time to CMV reactivation was 42 (31–53) days (Figure 1). Patients with acute myeloid leukemia were significantly less likely to have CMV reactivation (39% vs. 55%, P < 0.01) and those with myelodysplastic syndromes had a non-significantly higher risk (24% vs. 17%, P = 0.06). 4 (1%) patients had a documented clinical manifestation of CMV disease (3 pneumonia and 1 pancreatitis). One-year mortality was 36% (148/409); there was no significant difference in mortality (37.5% vs. 35.0%, P = 0.60) or cause of death (P = 0.30) between patients with and without CMV reactivation (Figure 2). The most frequent causes of death among CMV viremic patients were recurrent/persistent disease (35%), acute graft vs. host disease (GVHD) (22%), infection (19%), and chronic GVHD (11%). CMV was documented as the primary cause of death for 2 patients.ConclusionNearly half of HSCT recipients had CMV reactivation and more than a third died within one year of transplant. However, incidence of CMV disease was rare and reactivation was not associated with increased mortality. Further study is needed to identify risk factors for CMV reactivation, infection and mortality in this population.Disclosures J. P. Furuno, Merck & Co.: Consultant and Grant Investigator, Consulting fee, Research grant and Speaker honorarium. L. Strasfeld, Merck: Independent Contractor, Salary. J. C. McGregor, Merck & Co.: Grant Investigator, Research grant

The influence of Helicobacter pylori on the ethnic distribution of esophageal eosinophilia.

Environmental factors associated with ethnicity may contribute to the occurrence of eosinophilic esophagitis. Our study aimed to investigate the influence of Helicobacter pylori on the ethnic variation of esophageal eosinophilia in a large national sample of patients undergoing esophago-gastro-duodenoscopy. The Miraca Life Sciences Database is an electronic repository of histopathologic patient records. A case-control study evaluated the influence of ethnicity on the occurrence of esophageal eosinophilia and how age, gender, and histologic diagnosis of H.pylori modify this relationship. The total study population comprised 596479 subjects, of whom 25969 harbored a diagnosis of esophageal eosinophilia. Young age, male sex, and H.pylori infection in declining order exerted the strongest influence on the occurrence of esophageal eosinophilia. In comparison with the population comprising of Caucasians and African-Americans, esophageal eosinophilia was less common among patients of African (OR=0.10, 95% CI=0.01-0.46), Middle Eastern (0.22,0.15-0.31), East Asian (0.32, 0.26-0.38), Indian (0.28, 0.21-0.37), Hispanic (0.40, 0.37-0.43), or Jewish descent (0.58, 0.51-0.66), but more common among patients of Northern European descent (1.25, 1.07-1.45). With the exception of Northern Europeans, all ethnic subgroups were characterized by a higher prevalence of H.pylori than the comparison group. A low prevalence of H.pylori was significantly associated with a high prevalence of esophageal eosinophilia (R2 =0.90, P<.001). Esophageal eosinophilia prevalence markedly varies by patient ethnicity. As there is a strong inverse correlation between H.pylori and esophageal eosinophilia, H.pylori infection may be in part responsible for the observed ethnic distribution of esophageal eosinophilia.

Medieval Multilingualism in Poland: Creating a Corpus of Greater Poland Court Oaths (Rotha)

AbstractIn this paper we introduce the research plan for the preparation of a searchable electronic repository of the earliest extant legal oaths from medieval Poland drawing on the expertise in historical corpus-building developed for the history of English. The oaths survive in the overwhelmingly Latin land books from the period between 1386 and 1446 for six localities Greater Poland, in which the land courts operated: Poznań, Kościan, Pyzdry, Gniezno, Konin and Kalisz. A diplomatic edition of the oaths was published in five volumes by Polish historical linguists (Kowalewicz &amp; Kuraszkiewicz 1959–1966). The edition is the only comprehensive resource of considerable scope (over 6300 oaths from the years 1386–1446) for the study of the earliest attestations of the Polish language beyond glosses. Recognising some limitations, but most of all its unparalleled coverage of the coexistence of Latin and the vernacular, the ROThA project embarks on transforming the edition into an open up-to-date digital resource. We thus aim to facilitate research into the history of Polish and Latin as well as of the legal system and the related social and linguistic issues of the period.

CEBS: a comprehensive annotated database of toxicological data.

The Chemical Effects in Biological Systems database (CEBS) is a comprehensive and unique toxicology resource that compiles individual and summary animal data from the National Toxicology Program (NTP) testing program and other depositors into a single electronic repository. CEBS has undergone significant updates in recent years and currently contains over 11 000 test articles (exposure agents) and over 8000 studies including all available NTP carcinogenicity, short-term toxicity and genetic toxicity studies. Study data provided to CEBS are manually curated, accessioned and subject to quality assurance review prior to release to ensure high quality. The CEBS database has two main components: data collection and data delivery. To accommodate the breadth of data produced by NTP, the CEBS data collection component is an integrated relational design that allows the flexibility to capture any type of electronic data (to date). The data delivery component of the database comprises a series of dedicated user interface tables containing pre-processed data that support each component of the user interface. The user interface has been updated to include a series of nine Guided Search tools that allow access to NTP summary and conclusion data and larger non-NTP datasets. The CEBS database can be accessed online at http://www.niehs.nih.gov/research/resources/databases/cebs/.

University Hospital Waterford: 5-year experience of cutaneous melanoma.

The incidence of cutaneous melanoma (CM) continues to rise in Ireland. Despite significant advances in melanoma molecular therapy, surgery remains the mainstay of treatment for CM. The University Hospital Waterford (UHW) prospectively maintained CM registry was established in 2010. To summarize 5-year experience (2010-2015) of primary CM presenting to UHW. Data were retrospectively obtained from a central electronic pathology and radiology repository augmented by HIPE data and theatre logs. Data collected included patient demographics and clinico-pathological characteristics, specimen number, size, anatomical location, melanoma subtype, Breslow thickness, Clark's level, ulceration, and mitosis. 592 CMs were managed in UHW during the study period. Overall, females comprised the majority of cases with mean age at presentation 60.78±18.29years. The most commonly affected anatomical location was the lower limb (26.7%) followed by the back (15.1%), upper limb (15.07%), and face (14.40%). Superficial spreading and lentigo maligna were the most common histological subtype accounting for 19.8 and 20%, respectively. Overall, the mean Breslow depth was 2.4±3.7mm with corresponding Clark's Level III. Sentinel lymph node positivity was 39/103 (37.89%) most commonly located in the axilla (53.8%) and groin (30.7%). There has been a steady increase in the number of cutaneous melanoma presentations over the past 5-years to the South East Cancer Centre. Patients are managed best by prompt surgical excision and multidisciplinary management. Our results are in keeping with international standards and work continues in determining overall 5-year survival and recurrence rates.

The influence of Helicobacter pylori on the ethnic distribution of Barrett's metaplasia.

Environmental risk factors associated with ethnicity may contribute to the occurrence of Barrett's metaplasia. To investigate the interaction between ethnicity and Helicobacter pylori infection in the occurrence of Barrett's metaplasia among patients undergoing oesophago-gastro-duodenoscopy. The Miraca Life Sciences Database is an electronic repository of histopathological patient records. A case-control study evaluated the influence of age, gender, ethnicity and histological diagnosis of H. pylori on the occurrence of Barrett's metaplasia. The total study population comprised 596 479 subjects, of whom 76 475 harboured a diagnosis of Barrett's metaplasia. Male sex, age and H. pylori infection in declining order exerted the strongest influence on the occurrence of BM. In comparison with the population comprising Caucasians and African Americans, Barrett's metaplasia was less common among subjects of African (OR = 0.09, 95% CI = 0.01-0.43), Middle Eastern (0.26, 0.20-0.34), East Asian (0.35, 0.31-0.40), Indian (0.39, 0.32-0.47), Hispanic (0.62, 0.59-0.64) or Jewish descent (0.50, 0.45-0.54), but more common among subjects of Northern European descent (1.14, 1.03-1.26). With the exception of Jews and Northern Europeans, all other ethnic subgroups were characterised by a higher prevalence of H. pylori than the comparison group. A low prevalence of H. pylori was significantly associated with a high prevalence of Barrett's metaplasia (R2 = 0.82, P < 0.001), as well as dysplasia or oesophageal adenocarcinoma (R2 = 0.81, P < 0.001). Our analysis reveals an inverse relationship between the prevalence of Barrett's metaplasia and H. pylori gastritis among different ethnic groups within the United States.

Judging Knowledge in the Digital Age: The Role of External‐Memory Organization

Two studies examined relations between features of external‐memory repositories (personal computers) and confidence in knowing. Participants judged their confidence in knowledge related to their work or studies and then answered questions about the way they store and use information. Participants who maintained more organized repositories were more confident in their knowledge. Furthermore, moderation analyses showed that the participants who navigated through their files by manually clicking through folders to find documents, but not those who use an automated search feature, felt more knowledge confident if they maintained a well‐organized electronic repository. These results provide evidence for relation between assessments of internally ‘stored’ knowledge and the degree of organization of their externally stored ‘knowledge.’ Copyright © 2016 John Wiley &amp; Sons, Ltd.

Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement

Exercise is effective for prevention and management of acute and chronic health conditions. However, trial descriptions of exercise interventions are often suboptimal, leaving readers unclear about the content of effective...

On-treatment and off-treatment efficacy of entecavir in a real-life cohort of chronic hepatitis B patients.

Entecavir (ETV) is a potent nucleoside analogue with high genetic barrier to resistance. In this study, real-life clinical experiences in the long-term use of ETV and the durability of its off-treatment effectiveness were analyzed. This study was based on a large real-life cohort of 2240 chronic hepatitis B patients treated with ETV between January 2006 and December 2012 using a centralized electronic data repository. Among 2240 patients, 804 patients were treatment naive and underwent ETV monotherapy. Their mean treatment duration was 712±493 days, with a cumulative proportion of patients achieving HBV DNA less than 300 copies/ml in 85.8, 95.7, and 97.6% at years 1, 2, and 3, respectively. Predictors for earlier virologic response were female sex, lower HBV DNA, higher alanine transaminase, lower platelet count, and HBeAg negativity at baseline. In patients who achieved virologic response and HBeAg loss, the cumulative relapse rate was 91.3% in 2 years after the cessation of treatment. During the treatment, 34 patients developed hepatocellular carcinoma, among whom 30 patients had cirrhosis before treatment initiation. ETV treatment showed efficient virologic response as the treatment duration was extended, but off-treatment efficacy was not durable, and the antiviral treatment showed some limitation in preventing hepatocellular carcinoma among liver cirrhosis patients, implying that treatment cessation should be taken into consideration more carefully. This study from a real-life cohort may provide data on treating chronic hepatitis B patients more close to everyday clinical practice.