Abstract:
PURPOSE:The purpose of this paper is to describe the infrastructure of the total joint replacement registry of a large integrated healthcare system's and emphasize challenges associated with orthopedic device classification and evaluation. METHODS:Using a large integrated healthcare system innovative infrastructure including electronic health record data, administrative data sources, and registry data collection, we evaluated device choice and outcomes of total hip arthroplasty (THA). Devices were classified into type of bearing surface (alternative versus traditional). Multiple imputation was used to accommodate missing data, and a logistic regression model was applied to assess the impact of patient and surgeon factors on choice of bearing surface. A Cox regression model was used to evaluate risk of aseptic revision while controlling for surgeon, site, and patient characteristics. Adjusted cumulative probability-of-event curves were created, comparing survival of alternative against traditional bearings of devices, with aseptic revision as the outcome of interest. RESULTS:The study sample consisted of 25,377 primary THAs with an average follow-up of 2.7 years. Choice of bearing surface varied by surgeon and patient characteristics. After adjusting for patient, surgeon, and hospital covariates, results showed that the risk of aseptic revision associated with alternative bearings did not differ significantly from traditional bearing surfaces (hazard ratio = 1.33; 95% confidence interval: 0.90, 1.98). CONCLUSIONS:Clinically rich data from a registry with linkages to electronic health records and other administrative databases improve identification of exposures, outcomes, and patient subgroups in medical device evaluation. These various data sources facilitate refined adjustment for potential confounders such as hospital, surgeon, and patient factors and ensure comprehensive device performance evaluation within registries.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Paxton EW,Ake CF,Inacio MC,Khatod M,Marinac-Dabic D,Sedrakyan Adoi
10.1002/pds.3228subject
Has Abstractpub_date
2012-05-01 00:00:00pages
53-9eissn
1053-8569issn
1099-1557journal_volume
21 Suppl 2pub_type
杂志文章abstract:PURPOSE:To investigate suicide-related over-the-counter (OTC) analgesic medication exposures among individuals ≥6 years old reported to United States (US) poison control centers. METHODS:Data from the National Poison Data System for the years 2000-2018 were retrospectively analyzed. RESULTS:From 2000 to 2018, US pois...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4997
更新日期:2020-09-01 00:00:00
abstract:PURPOSE:Medicaid programs are concerned about inappropriate, potentially hazardous, and costly off-label use of second-generation antipsychotics (SGAs). Several states are exploring policies aimed at managing low-dose quetiapine, commonly prescribed for off-label conditions. This study aimed to characterize longitudina...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3538
更新日期:2014-01-01 00:00:00
abstract:PURPOSE:Patients initiating warfarin therapy generally experience a dose-titration period of weeks to months, during which time they are at higher risk of both thromboembolic and bleeding events. Accurate prediction of prolonged dose titration could help clinicians determine which patients might be better treated by al...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4069
更新日期:2016-11-01 00:00:00
abstract:PURPOSE:Postmarketing drug safety surveillance relies upon measures of disproportionate reporting in spontaneous reporting systems. It has been hypothesized that products or events reported frequently may "mask" signals. METHODS:We analyzed the masking effect of vaccines in pediatrics in the EudraVigilance database by...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4623
更新日期:2018-11-01 00:00:00
abstract::The use of healthcare databases in research provides advantages such as increased speed, lower costs and limitation of some biases. However, database research has its own challenges as studies must be performed within the limitations of resources, which often are the product of complex healthcare systems. The primary ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2229
更新日期:2012-01-01 00:00:00
abstract:PURPOSE:Propensity scores are used in observational studies to adjust for confounding, although they do not provide control for confounders omitted from the propensity score model. We sought to determine if tests used to evaluate logistic model fit and discrimination would be helpful in detecting the omission of an imp...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.986
更新日期:2005-04-01 00:00:00
abstract:BACKGROUND:Raised blood pressure associated with the sodium excipient content of soluble or effervescent analgesic has been previously reported. However, the influence of other anions associated with sodium on blood pressure is still controversial. METHODS:Observational study of elderly hypertensive patients with unco...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1701
更新日期:2009-05-01 00:00:00
abstract:PURPOSE:This study was performed to evaluate the change of prescribing patterns after the regulatory action regarding fluoroquinolones in pediatric patients. METHODS:We conducted a time series analysis using the Korea Health Insurance Review and Assessment Service National Patients Sample database. Study subjects cons...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3696
更新日期:2014-12-01 00:00:00
abstract:PURPOSE:Opioid analgesic use in chronic non-cancer pain (CNCP) is increasingly prevalent, but the benefits and risks are inadequately understood. In France, tramadol is one of the most used prescription opioids, but studies on its misuse liability in CNCP are still lacking. The aim was to assess the incidence of tramad...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4056
更新日期:2016-09-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3260
更新日期:2012-05-01 00:00:00
abstract::There is an increasing reliance on databases of healthcare records for pharmacoepidemiology and other medical research, and such resources are often accessed over a long period of time so it is vital to consider the impact of changes in data, access methodology and the environment. The authors discuss change in commun...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4004
更新日期:2016-07-01 00:00:00
abstract:PURPOSE:Increased post-marketing reports of 'interstitial pneumonia' as an adverse drug reaction (ADR) from the use of gefitinib, irinotecan, or leflunomide among patients in Japan have not been noted in other countries. The WHO International Drug Monitoring Database was analyzed to examine Japan's pattern of reporting...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1071
更新日期:2005-11-01 00:00:00
abstract:BACKGROUND AND AIMS:Epidemiologic studies on a potential chemopreventive effect of statin therapy have yielded conflicting results. We sought to clarify whether long-term statin therapy has a chemopreventive effect on the risk of colorectal cancer (CRC) in a large, population-representative cohort. METHODS:A nested ca...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1599
更新日期:2008-09-01 00:00:00
abstract:PURPOSE:We aimed to quantify the extent of over-the-counter (OTC) low-dose aspirin use among patients in The Health Improvement Network (THIN) in the UK. METHODS:In September 2013, a random sample of low-dose aspirin users (75 past users and 75 never users) was identified based on prescriptions recorded in THIN. Prima...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3926
更新日期:2016-04-01 00:00:00
abstract:PURPOSE:De-implementation of low-value services among patients with limited life expectancy is challenging. Robust mortality prediction models using routinely collected health care data can enhance health care stakeholders' ability to identify populations with limited life expectancy. We developed and validated a claim...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4769
更新日期:2019-05-01 00:00:00
abstract:PURPOSE:To compare the frequency of adverse drug reactions (ADRs) recorded by doctors with perceived ADRs reported by patients during hospitalization and post-discharge and to compare both to formal reporting in Thailand. SETTING:Tertiary teaching hospital, North-East Thailand. METHODS:Over a 6-month period doctors w...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1708
更新日期:2009-03-01 00:00:00
abstract::The UK Drug Utilization Research Group's (DURG) Regional Meeting 'New Horizons: Pharmacovigilance' was hosted by the Drug Safety Research Unit (DSRU) at Southampton on 19 May 2000. Opening the meeting, Dr Keith Beard, UK DURG chairman, welcomed delegates and speakers and thanked the DSRU team for hosting the meeting. ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/1099-1557(200009/10)9:5<429::AID-PDS528>3.
更新日期:2000-09-01 00:00:00
abstract:PURPOSE:We discuss the practical advantages and challenges of sharing controls among two or more concurrently conducted case-control studies. METHODS:We conducted two case-control studies, one of breast cancer and the other of endometrial cancer, with overlapping, shared control groups. The studies had overlapping geo...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1130
更新日期:2005-08-01 00:00:00
abstract:BACKGROUND:Following approval in the EU in 2002 and the USA in 2003, an Intensive Safety Surveillance Scheme (IS(3) ) was initiated to educate prescribers on the appropriate use of miglustat for the treatment of type I Gaucher disease (GD1), and to actively solicit safety-relevant information. This report summarises da...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,多中心研究
doi:10.1002/pds.3760
更新日期:2015-03-01 00:00:00
abstract:PURPOSE:Bias analysis methods are developed for application to 2 x 2 tables, which may be crude or stratified data. Methods for application to associations adjusted for multiple covariates, such as associations from regression modeling, are rarely seen. We have developed probabilistic methods to evaluate bias from dise...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1938
更新日期:2010-06-01 00:00:00
abstract:BACKGROUND:Laboratory technicians, laboratory supervisors, decontamination/remediation workers, and environmental investigators are at increased risk for repeated occupational exposure to Bacillus anthracis. In 2002, the Advisory Committee on Immunization Practices (ACIP) recommended pre-exposure vaccination for these ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1302
更新日期:2006-12-01 00:00:00
abstract:PURPOSE:We present a new population-based pharmacoepidemiological (PE) database obtained from statutory health insurances (SHIs) that is able to generate signals, to monitor prescribed drugs and to describe drug utilisation. We discuss methodological features of the database and we assess to which degree this database ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1545
更新日期:2008-03-01 00:00:00
abstract:PURPOSE:Research using healthcare databases often includes patients frequently excluded from clinical trials; yet it is not known whether commonly used data represents the overall population or specific sub-populations of interest. We aimed to examine population representativeness from data sources in recent research s...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5087
更新日期:2020-11-01 00:00:00
abstract:PURPOSE:Little is known about the effects of drug-drug interactions between valacyclovir and non-steroidal anti-inflammatory drugs (NSAIDs). In this study, we analysed the adverse event 'acute kidney injury (AKI)' resulting from a possible interaction between loxoprofen (a non-selective NSAID) and valacyclovir in repor...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3626
更新日期:2014-11-01 00:00:00
abstract:PURPOSE:In order to assess the short-term safety and tolerability of newly prescribed antihypertensive monotherapies in Korean patients, a prospective study was carried out. METHODS:A total of 1181 patients were observed from July 1997 to August 1999. At 2, 4, 8 and 12 weeks after initiation of antihypertensive monoth...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.554
更新日期:2000-12-01 00:00:00
abstract:PURPOSE:Meta-analysis is a quantitative approach to summarize the findings from several studies and has been applied with increasing frequency to clinical trials. Because of their sample size and duration limitations, experimental studies (ESs) could not be able to detect late or rare adverse events (AEs), which may be...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.2260
更新日期:2012-01-01 00:00:00
abstract:PURPOSE:Early detection of risky behaviors involving prescription opioids can assist prescribers in implementing safer prescribing. Patient-to-prescriber travel patterns may indicate potential opioid misuse. We introduce doctor hopping, patients bypassing nearby prescribers in favor of more distant ones, as a new spati...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4838
更新日期:2019-08-01 00:00:00
abstract:PURPOSE:First-in-class (FIC) drugs with novel modes of action pose concerns regarding important postmarketing safety issues. The purpose of this study was to analyze the factors related to the occurrence of postmarketing safety-related regulatory actions (PSRAs) for drugs approved in the United States (US), with a focu...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4634
更新日期:2018-12-01 00:00:00
abstract:PURPOSE:To display a ranked presentation of the data given in the Drug Analysis Prints (DAPs) provided by the MHRA/CSM so that the monitoring clinician may be readily alerted to the most important findings. The practolol DAP is taken as an example of the presentation. METHOD:The data for the ranked system organ classe...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1144
更新日期:2005-10-01 00:00:00
abstract:PURPOSE:We sought to determine the incidence and risks for severe thrombocytopenia (platelets < 50,000/μL) in United States Veteran patients treated with pegylated interferon (PEG-IFN) plus ribavirin for hepatitis C virus-positive (HCV) chronic liver disease (CLD). METHODS:Using a retrospective, observational cohort s...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3585
更新日期:2014-05-01 00:00:00