pinecone/core-2020-05-10-deduplication huggingface dataset:
Epidemiology of potentially inappropriate medication use in elderly patients in Japanese acute care hospitals.

[Purpose]The elderly receive many medications which may have adverse effects. Little evidence is available about the epidemiology of potentially inappropriate medications being prescribed to the elderly in Japan as defined by the Beers criteria, or whether or not these medications result in harm when used in this population. [Methods]We conducted a prospective cohort study of patients aged ≥65 years who were admitted to three acute care hospitals in Japan. Trained research nurses followed up patients from randomly selected wards and collected data about their medications and all potential adverse drug events (ADEs). Two independent reviewers evaluated all the data. The use of potentially inappropriate medications and their effects on patients were identified using the updated Beers criteria. [Results]A total of 2155 elderly patients were eligible; 56.1% received at least one drug listed in the Beers criteria (BL drug). The rates of BL drug prescriptions were 103.8 per 100 admissions and 53.7 per 1000 patient-days, and the incidence rate of ADEs related to BL drugs was 1.7 per 100 BL drug prescriptions. Among patients aged ≥65 years, relatively younger patients (p = 0.0002) and those with less complications (p = 0.04) were likely to be prescribed BL drugs. [Conclusions]Although BL drugs were frequently prescribed to elderly Japanese inpatients, the incidence of related ADEs appeared infrequent. These data suggest that re-evaluation of the appropriateness of the Beers criteria is needed before they are used in Japan and other nations to assess quality or for decision support
Stroke risk and NSAIDs: A systematic review of observational studies

Aims: To perform a quantitative systematic review of observational studies on the risk of stroke associated with the use of individual NSAIDs. Methods and results: Searches were conducted using the Medline database within PubMed (1990-2008). Observational cohort or case-control studies were eligible if reported on the risk of cardiovascular events associated with individual NSAIDs versus the nonuse of NSAIDs. We found 3193 articles, in which 75 were eligible for review and abstraction. Of the 75 articles, 6 reported relative risk (RR) of stroke. Data were abstracted into a database using a standardized entry form. Two authors assessed study quality, and discrepancies were resolved by consensus. The pooled RR of all subtypes of incident stroke was increased with the current use of rofecoxib (RR=1.64, 95% CI=1.15-2.33) and diclofenac (RR=1.27, 95% CI=1.08-1.48). The pooled estimates for naproxen, ibuprofen, and celecoxib were close to unity. The risk of ischemic stroke was also increased with rofecoxib (RR=1.82, 95% CI=1.09-3.04) and diclofenac (RR=1.20, 95% CI=0.99-1.45). Data were inadequate to estimate the pooled RR by dose and duration, for other individual NSAIDs or nonischemic stroke subtypes. Conclusion: This meta-analysis supports an increased risk of ischemic stroke with the current use of rofecoxib and diclofenac. Additional studies are required to evaluate most individual NSAIDS, the effect of dose and duration, and the subtypes of stroke
Comorbidities in an asthma population 8-29 years old: a study from the Norwegian Prescription Database

This is the accepted manuscript version of the article. Published version is available at <a href=http://dx.doi.org/10.1002/pds.2233>Pharmacoepidemiology & Drug Safety</a> This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self Archiving.Purpose: To examine occurrence of chronic diseases and antimicrobial treatment in an asthma
population 8-29 years old, compared to the general population.
Methods: In this cross-sectional study, the asthma population was identified from the general population (retrieved from a census covering the entire Norwegian population) by using filled
prescriptions on asthma drugs as a proxy measure of current asthma. The outcome was excess
occurrence of specific diseases (comorbidity) among asthmatics, compared to the age-specific
general population. Diseases were defined by filled prescriptions with specific diagnostic
codes with asthma, compared with the age-specific general population. Diseases were
defined by filled prescriptions with specific diagnostic codes (International Classification of
Primary Care 2nd edition [ICPC-2] or International Classification of Diseases 10th revision
[ICD-10]) during a 1-year period in the Norwegian Prescription Database. Nine chronic
diseases were examined: ADHD, epilepsy, migraine, mental illness, cardiovascular disease,
diabetes, autoimmune disorders, gastro-oesophageal reflux disease (GORD), allergy.
Additionally, antibacterials recommended for respiratory tract infections and antivirals were
examined (defined by ATC codes). Standardized Morbidity Ratios (SMR) for each disease
was calculated.
Results: 59% of the population had at least one of nine chronic diseases examined, compared to 18% in the general population. Few individuals had more than one additional chronic disease (6%
of males, 8% of females). SMRs were increased for all diseases except diabetes, implying higher than expected occurrence of the specific diseases in asthmatics. This pattern was observed in both age groups (8-19 and 20-29 years) and genders. Allergy and GORD had highest SMR (range 3.2-4.8) while the other diseases were in the range 1.2-2.5. Conclusions: An excess occurrence of comorbidities was found in the population with asthma. A majority of asthmatics had one additional chronic disease, and few had more than one
Timing of androgen deprivation therapy use and fracture risk among elderly men with prostate cancer in the United States

Purpose  Fractures are a recognized consequence of androgen deprivation therapy (ADT); however, less is known about the incidence of fracture in relation to the timing of ADT use or the impact of fracture on mortality in men with prostate cancer.    Methods  Using data from the Surveillance, Epidemiology, and End Results–Medicare linked database, we estimated adjusted hazard ratios (aHRs) using time‐dependent Cox regression for fracture incidence related to the recency of exposure and dose among prostate cancer patients on gonadotropin‐releasing hormone (GnRH) agonists, as well as mortality associated with fractures.    Results  In our cohort of 80 844 patients, ADT was associated with an increased rate of fracture in both non‐metastatic patients (aHR = 1.34; 95% confidence interval [CI] = 1.29–1.39) and metastatic patients (aHR = 1.51; 95%CI = 1.36–1.67). Fracture rates increased with increasing cumulative GnRH dose but decreased with increasing number of months since last use in each dose category. The mortality rate doubled for men experiencing a fracture after their diagnosis compared with that for men who did not experience a fracture (aHR = 2.05; 95%CI = 1.98–2.12).    Conclusions  ADT in elderly men with prostate cancer increased the incidence of fractures, and the effect appears to diminish with increasing time since the last dose of a GnRH agonist. Experiencing a fracture after the diagnosis of prostate cancer was associated with decreased survival. Copyright © 2011 John Wiley & Sons, Ltd
Psychotropic medication use in adolescents with intellectual disability living in the community

Purpose\ud
Information on the use of psychotropic medications in adolescents with intellectual disability is scant. Such information can guide interventions to improve psychotropic medication use in this population. We investigated the prevalence of, and factors associated with, psychotropic medication use in adolescents with intellectual disability in Australia who live in the community.\ud
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Methods\ud
Cross-sectional data were obtained from adolescents with intellectual disability living in the community in South East Queensland, Australia, between February 2007 and September 2010. Self-reported information on medication use was extracted from a health screening tool. Demographic and medical data were collected through parent/caregiver surveys. Medications were classified according to the Anatomical Therapeutic Chemical classification system. Psychopathology was assessed using the Developmental Behaviour Checklist Short Form. Logistic regression analysis was used to assess the association of demographic and medical characteristics with psychotropic medication use.\ud
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Results\ud
There were 176 participants (median age = 16 years, range = 11–19 years; 55% male). Psychotropics were used by 20% of participants. Psychostimulants were the commonest psychotropic class, used by 9% of participants. Multipsychotropic prescribing was not common with only seven participants using more than one psychotropic agent. After adjusting for potentially confounding variables, use of psychotropic medications was significantly associated with male gender (adjusted odds ratio = 3.6; 95% confidence interval = 1.3–9.5) and having major behaviour problems (3.1; 1.1–8.9).\ud
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Conclusions\ud
Adolescents with intellectual disability use a wide range of psychotropic medications. Being male and having major behaviour problems are associated with the use of psychotropic medications. Research examining the rationale for psychotropic prescribing in this population is needed. Copyright © 2013 John Wiley & Sons, Ltd
The increase in prescriptions of bisphosphonates and the incidence proportion of osteonecrosis of the jaw after risk communication activities in Japan: a hospital-based cohort study.

[Purpose]The purpose of this study was to investigate the impact of risk communication about bisphosphonate (BP)-related osteonecrosis of the jaw (ONJ) on the number of reported cases to the Drug Adverse Reactions Reporting System and on the incidence proportion of ONJ in a hospital-based cohort study in Japan. [Method]We conducted a survey of the safety information on BP-related ONJ available from regulatory authorities, pharmaceutical manufacturers and academic associations. We also performed a trend analysis of a dataset from the Drug Adverse Reactions Reporting System and a sub-analysis, using previously constructed data from a retrospective cohort study. [Results]Risk communication from pharmaceutical manufacturers and academic associations began within 1 year after revisions were made to the package inserts, in October 2006. Twenty times more cases of ONJ have been reported to regulatory authority since 2007, compared with the period before 2007. In our cohort, the incidence proportion of ONJ during and after 2009 was four times greater than before 2009. During this period, BPs were frequently prescribed, whereas there was no increase in the use of alternative agents, such as selective estrogen receptor modulators. [Conclusion]ONJ was increasingly diagnosed after risk communication efforts, but the impact of the communications was not clear. Safety notifications were diligently disseminated after the package insert was revised. However, there was no surveillance for ONJ before the revision
Appropriate antibiotic prescribing in Community-Acquired Pneumonia in a Norwegian hospital setting

The papers of this thesis are not available in Munin.<br>Paper I. MAT-CAP: a novel medication assessment tool to
explore adherence to clinical practice guidelines in community-acquired pneumonia. Høgli JU, Småbrekke L, Garcia BH. Available in <a href=http://dx.doi.org/10.1002/pds.3640>Pharmacoepidemiology and Drug Safety 2014; 23: 933–941</a><br>Paper II. Adherence to guideline for empirical antibiotics is safe and reduces risk of readmission of hospitalised patients with community-acquired pneumonia in Norway. Høgli JU, Garcia BH, Svendsen K, Skogen V, Småbrekke L. (Manuscript)<br>Paper III. An audit and feedback intervention study increased appropriate antibiotic prescribing at a Norwegian hospital. Høgli JU, Garcia BH, Skjold F, Skogen V, Småbrekke L. (Manuscript)Appropriate antibiotic prescribing is associated with favourable levels of antimicrobial resistance and clinical outcomes. Literature has indicated that antibiotic treatment of hospitalised patients with community-acquired pneumonia (CAP), the leading cause of death due to infection in adults worldwide, have potential for improvement. The overall aim of this PhD-work has been to promote appropriate antibiotic prescribing in hospitalised patients with CAP. We have developed and validated a Medication Assessment Tool for CAP (MAT-CAP) for retrospective audit of antibiotic prescribing at the University Hospital North Norway (UNN). Consequently, using this tool, areas with low and high quality of prescribing can be identified. Further, we have explored the association between adherence to Norwegian guideline recommendations and mortality, risk of readmission and prolonged length of stay for inpatients with CAP. We identified that adherence to guideline on empirical antibiotic was high, safe and associated with reduced risk of readmission to hospital within 30-days in a selective group of CAP-patients admitted to UNN. Our findings support the Norwegian guideline recommendations, and demonstrate the importance of having guidelines adapted to local and national levels of antimicrobial resistance. Third, in an intervention study we tailored improvement in antibiotic prescribing. The prescribing of appropriate empirical antibiotics increased substantially as a consequence of the intervention, and the effect sustained six months post intervention. However, for reducing total treatment duration and achieving dosage optimization of benzylpenicillin additional prospective interventions are warranted
Beginning and duration of pregnancy in automated health care databases:Review of estimation methods and validation results

Purpose: To describe methods reported in the literature to estimate the beginning or duration of pregnancy in automated health care data, and to present results of validation exercises where available. Methods: Papers reporting methods for determining the beginning or duration of pregnancy were identified based on Pubmed searches, by consulting investigators with expertise in the field and by reviewing conference abstracts and reference lists of relevant papers. From each paper or abstract, we extracted information to characterize the study population, data sources, and estimation algorithm. We then grouped these studies into categories reflecting their general methodological approach. Results: Methods were classified into 5 categories: (i) methods that assign a uniform duration for all pregnancies, (ii) methods that assign pregnancy duration based on preterm-delivery or health care related codes, or codes for other pregnancy outcomes, (iii) methods based on the timing of prenatal care, (iv) methods based on birth weight, and (v) methods that combine elements from 2 and 3. Validation studies evaluating these methods used varied approaches, with results generally reporting on the mistiming of the start of pregnancy, incorrect estimation of the duration of pregnancy, or misclassification of drug exposure during pregnancy or early pregnancy. Conclusions: In the absence of accurate information on the beginning or duration of pregnancy, several methods of varying complexity are available to estimate them. Validation studies have been performed for many of them and can serve as a guide for method selection for a particular study
Literature review of visual representation of the results of benefit–risk assessments of medicinal products

Background The PROTECT Benefit–Risk group is dedicated to research in methods for continuous benefit–risk monitoring of medicines, including the presentation of the results, with a particular emphasis on graphical methods. Methods A comprehensive review was performed to identify visuals used for medical risk and benefit–risk communication. The identified visual displays were grouped into visual types, and each visual type was appraised based on five criteria: intended audience, intended message, knowledge required to understand the visual, unintentional messages that may be derived from the visual and missing information that may be needed to understand the visual. Results Sixty-six examples of visual formats were identified from the literature and classified into 14 visual types. We found that there is not one single visual format that is consistently superior to others for the communication of benefit–risk information. In addition, we found that most of the drawbacks found in the visual formats could be considered general to visual communication, although some appear more relevant to specific formats and should be considered when creating visuals for different audiences depending on the exact message to be communicated. Conclusion We have arrived at recommendations for the use of visual displays for benefit–risk communication. The recommendation refers to the creation of visuals. We outline four criteria to determine audience–visual compatibility and consider these to be a key task in creating any visual. Next we propose specific visual formats of interest, to be explored further for their ability to address nine different types of benefit–risk analysis information
Recommendations for benefit–risk assessment methodologies and visual representations

Purpose The purpose of this study is to draw on the practical experience from the PROTECT BR case studies and make recommendations regarding the application of a number of methodologies and visual representations for benefit–risk assessment. Methods Eight case studies based on the benefit–risk balance of real medicines were used to test various methodologies that had been identified from the literature as having potential applications in benefit–risk assessment. Recommendations were drawn up based on the results of the case studies. Results A general pathway through the case studies was evident, with various classes of methodologies having roles to play at different stages. Descriptive and quantitative frameworks were widely used throughout to structure problems, with other methods such as metrics, estimation techniques and elicitation techniques providing ways to incorporate technical or numerical data from various sources. Similarly, tree diagrams and effects tables were universally adopted, with other visualisations available to suit specific methodologies or tasks as required. Every assessment was found to follow five broad stages: (i) Planning, (ii) Evidence gathering and data preparation, (iii) Analysis, (iv) Exploration and (v) Conclusion and dissemination. Conclusions Adopting formal, structured approaches to benefit–risk assessment was feasible in real-world problems and facilitated clear, transparent decision-making. Prior to this work, no extensive practical application and appraisal of methodologies had been conducted using real-world case examples, leaving users with limited knowledge of their usefulness in the real world. The practical guidance provided here takes us one step closer to a harmonised approach to benefit–risk assessment from multiple perspectives
The association between benzodiazepines and influenza-like illness-related pneumonia and mortality: a survival analysis using UK Primary Care data

Purpose: Bacterial superinfections, including pneumonia, are frequent complications of influenza-like illness (ILI). Clinical and laboratory evidence suggests that benzodiazepines and Z-drugs may influence susceptibility to infections and mortality. We investigated whether benzodiazepines and zopiclone modify the occurrence of ILI-related pneumonia and mortality. \ud
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Methods: We obtained data on 804 051 ILI patients from a comprehensive primary care database, the Clinical Practice Research Datalink. The follow-up period started from the diagnosis of ILI for 30 days. Pneumonia and deaths occurring within the 30-day follow-up period were considered as potentially ‘ILI related’. Exposure to benzodiazepines and zopiclone was determined in the period preceding a diagnosis of ILI with current use defined as a prescription for benzodiazepines in the month prior to ILI diagnosis. Cox regression was used for the analyses. Adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) are presented. \ud
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Results: Influenza-like illness-related pneumonia and mortality were noted in 1117 and 707 ILI patients, respectively. Current exposure to benzodiazepines was associated with increased occurrence of both ILI-related pneumonia and mortality (ILI-related pneumonia adjusted HR 4.24, 95%CI [2.27, 7.95]; ILI-related mortality adjusted HR 20.69, 95%CI [15.54, 27.54]). A similar increase in ILI-related mortality but not pneumonia was observed with current zopiclone use (ILI-related mortality adjusted HR 10.86, 95%CI [6.93, 17.02]; ILI-related pneumonia adjusted HR 1.97, 95%CI [0.63, 6.12]). \ud
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Conclusion: Benzodiazepines may increase the likelihood of pneumonia and mortality related to ILI. A cautionary approach to prescribing benzodiazepine is suggested in people known to be at increased risk of pneumonia or mortality
Pharmacoepidemiological safety studies in children: a systematic review

Purpose: In order to identify challenges in pediatric pharmacoepidemiological safety studies, we assessed the characteristics of such (published) studies. Methods: Relevant articles from inception to 2013 were retrieved from Embase and Medline. We sequentially screened titles, abstracts and full texts with independent validation. We systematically collected data regarding general information, study methods and results. Results: Out of 4825 unique articles, 268 full texts (5.6%) were retained; 147 (54.9%) pertained to drugs rather than vaccines. Considering the 268 studies, 202 (75.4%) concerned children and adolescents (2 to 11 years) and 14 (5.3%) included preterm newborns. Most studies originated from North America (154 [57.5%]) or Europe (92 [34.3%]). Only 47 studies (17.5%) were privately funded. The majority (174 [64.9%]) were cohort studies. Out of 268 studies, 196 (73.1%) collected data retrospectively; paper medical charts were the most common data source for the exposures (85 [31.7%]) and outcomes (122 [45.5%]). Only 3 (2.0%) drug-only studies investigated rarely used drugs. Considering all 268 studies, only 27 (10.1%) reported sample size or power calculation. Most (75 [51.0%]) drug-only studies corrected confounding by multivariate modeling unlike stratification in 66 (55.9%) vaccine-only studies. Considering 75 child-only studies without any statistically significant result, 41 (54.7%) did not discuss lack of power. Conclusions: Although the field of pediatric pharmacoepidemiology is steadily developing evaluation seldom includes neonates, is mainly focused on few drug classes and safety outcomes and concerns mainly drug use in developed countries. Small study size is a specific challenge in pediatrics. Reporting should be improved. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd