Abstract:
BACKGROUND:Researchers using observational data to understand drug effects must make a number of analytic design choices that suit the characteristics of the data and the subject of the study. Review of the published literature suggests that there is a lack of consistency even when addressing the same research question in the same database. OBJECTIVE:To characterize the degree of similarity or difference in the method and analysis choices made by observational database research experts when presented with research study scenarios. RESEARCH DESIGN:On-line survey using research scenarios on drug-effect studies to capture method selection and analysis choices that follow a dependency branching based on response to key questions. SUBJECTS:Voluntary participants experienced in epidemiological study design solicited for participation through registration on the Observational Medical Outcomes Partnership website, membership in particular professional organizations, or links in relevant newsletters. MEASURES:Description (proportion) of respondents selecting particular methods and making specific analysis choices based on individual drug-outcome scenario pairs. The number of questions/decisions differed based on stem questions of study design, time-at-risk, outcome definition, and comparator. RESULTS:There is little consistency across scenarios, by drug or by outcome of interest, in the decisions made for design and analyses in scenarios using large healthcare databases. The most consistent choice was the cohort study design but variability in the other critical decisions was common. CONCLUSIONS:There is great variation among epidemiologists in the design and analytical choices that they make when implementing analyses in observational healthcare databases. These findings confirm that it will be important to generate empiric evidence to inform these decisions and to promote a better understanding of the impact of standardization on research implementation.
journal_name
Drug Safjournal_title
Drug safetyauthors
Stang PE,Ryan PB,Overhage JM,Schuemie MJ,Hartzema AG,Welebob Edoi
10.1007/s40264-013-0103-1subject
Has Abstractpub_date
2013-10-01 00:00:00pages
S15-25eissn
0114-5916issn
1179-1942journal_volume
36 Suppl 1pub_type
杂志文章相关文献
DRUG SAFETY文献大全abstract::In the original publication of the article, the trend line for non-EEA cases in figure 4 is incorrect. In this correction, the original Fig. 4 (Fig. 1) and the correct Fig. 4 (Fig. 2) are published. ...
journal_title:Drug safety
pub_type: 杂志文章,已发布勘误
doi:10.1007/s40264-018-0700-0
更新日期:2018-12-01 00:00:00
abstract:BACKGROUND:For many regularly used drugs, evidence for safe use in pregnancy has not been established. Despite this, international studies have identified high levels of drug prescribing among pregnant women. OBJECTIVE:To investigate the patterns of prescribing of drugs to women who gave birth in Tayside, Scotland, in...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/11532330-000000000-00000
更新日期:2010-07-01 00:00:00
abstract::Histone deacetylases (HDACs) are expressed at increased levels in cells of various malignancies, and the use of HDAC inhibitors has improved outcomes in patients with haematological malignancies (T-cell lymphomas and multiple myeloma). However, they are not as effective in solid tumours. Five agents are currently appr...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-018-0773-9
更新日期:2019-02-01 00:00:00
abstract:BACKGROUND:Depressive disorders and use of antidepressants are associated with adverse effects on sexual function. In pharmacoepidemiological studies, sexual disorders are reported by more than 50 % of patients taking serotonin reuptake inhibitors (SRIs). OBJECTIVE:The aim of this study was to determine the reporting ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-013-0069-z
更新日期:2013-07-01 00:00:00
abstract::Adoptive T cell therapy (ACT) is a safe and effective personalized cancer immunotherapy that can comprise naturally occurring ex vivo expanded cells (e.g., tumor-infiltrating lymphocytes [TIL]) or T cells genetically engineered to confer antigen specificity (T-cell receptor [TCR] or chimeric antigen receptor [CAR] eng...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-018-0779-3
更新日期:2019-02-01 00:00:00
abstract::In August 2015, the US Food and Drug Administration (FDA) made the controversial decision to approve flibanserin (Addyi®) for women experiencing hypoactive sexual desire disorder. A number of factors contributed to disagreements regarding the FDA's decision, including the product's two prior failed FDA reviews, the un...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-015-0389-2
更新日期:2016-05-01 00:00:00
abstract::Women who discover they are pregnant after exposure to a drug and pregnant women who have a condition that requires continued treatment during pregnancy are told to balance the benefits and risks of the exposure to justify continuation of treatment, discontinuation of treatment or, possibly, pregnancy termination. How...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200427060-00001
更新日期:2004-01-01 00:00:00
abstract:INTRODUCTION:As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals. OBJECTIVE:Our objective w...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-019-00870-x
更新日期:2020-01-01 00:00:00
abstract:BACKGROUND:An association between oral contraceptive (OC) use and venous thromboembolism (VTE) has long been recognized. However, no summary estimates of the increase in VTE risk associated with OC use have been available since 1995, and no meta-analyses have evaluated the VTE risk of new preparations containing drospi...
journal_title:Drug safety
pub_type: 杂志文章,meta分析,评审
doi:10.2165/11598050-000000000-00000
更新日期:2012-03-01 00:00:00
abstract:INTRODUCTION:Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. METHODS:Three major types of EHDs in China (i.e., a regional commu...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-017-0589-z
更新日期:2018-01-01 00:00:00
abstract::Similar to other beta-lactam antibacterials, carbapenems have a neurotoxic potential that seems to be higher than that of the penicillins and cephalosporins. Seizures have been reported in several large studies of patients treated with imipenem/cilastatin. However, it seems clear that the main factor increasing the ri...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199615020-00001
更新日期:1996-08-01 00:00:00
abstract::Gastroesophageal reflux is one of the most common reasons for referrals to paediatricians or paediatric gastroenterologists. Gastric acid-buffering agents, mucosal surface barriers and gastric anti-secretory agents are the main groups of medications currently used for treating gastroesophageal reflux disease (GERD) in...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-014-0154-y
更新日期:2014-05-01 00:00:00
abstract::Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of certain forms of cancers, raising hopes for many patients with otherwise unresponsive tumours. While these agents are generally well tolerated, clinical experience with them has highlighted their unexpected association with serious toxic effects on...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-013-0050-x
更新日期:2013-06-01 00:00:00
abstract::NSAIDs are widely used to treat pain and inflammation in osteoarthritis. Their use in this indication is generally intermittent and fluctuates with the intensity of the disease. Nonetheless, success of the therapy is frequently limited by injury to the gastrointestinal mucosa and complications such as bleeding, ulcera...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200427030-00003
更新日期:2004-01-01 00:00:00
abstract::The article vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues, written by Tomas Bergvall. G. Niklas Norén. Marie Lindquist, was originally published Online First without open access. ...
journal_title:Drug safety
pub_type: 已发布勘误
doi:10.1007/s40264-019-00803-8
更新日期:2019-06-01 00:00:00
abstract:INTRODUCTION:The prevalence of polymorphisms among the metabolising enzymes and pharmacodynamic receptors relevant for the thiazolidinediones differs by ethnic group, a factor that may modify risk of adverse drug events. OBJECTIVE:The aim of the study was to determine if the risk of oedema or heart failure associated ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-015-0318-4
更新日期:2015-09-01 00:00:00
abstract::Human papillomavirus (HPV) vaccines are now included in immunisation programmes in 71 countries. Unfortunately, uptake has been impacted in some countries by reduced confidence in the safety of the HPV vaccine. In 2013, we published an extensive review demonstrating a reassuring safety profile for bivalent (2vHPV) and...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-017-0625-z
更新日期:2018-04-01 00:00:00
abstract:BACKGROUND:The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/11319000-000000000-00000
更新日期:2010-02-01 00:00:00
abstract:BACKGROUND:Academic medical centres face the need to care for patients with complex medical conditions, educate physicians-in-training and conduct research, all with increasingly constrained budgets. The adoption of new therapeutic technology presents challenges and opportunities in each of these areas. Severe sepsis r...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200427150-00008
更新日期:2004-01-01 00:00:00
abstract::The use of triple regimens, often called highly active antiretroviral therapy (HAART), generally involving 2 nucleoside analogues and an HIV protease inhibitor, have been endorsed as the standard of care for persons with HIV initiating therapy by a number of sets of international guidelines. The widespread availabilit...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199920040-00002
更新日期:1999-04-01 00:00:00
abstract::The present review outlines the clinical relevance of pharmacokinetic drug interactions within the HMG-CoA reductase inhibitor class. These interactions can result in markedly increased or decreased plasma concentrations of some drugs within this class. However, the relationship between altered plasma concentrations a...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200326010-00002
更新日期:2003-01-01 00:00:00
abstract::Drugs used in the treatment of peptic ulcer disease may interact with the renal system in a variety of ways. Since many agents are eliminated by renal excretion, clearance of these agents may be reduced and half-life extended in the presence of renal insufficiency. The histamine H2-receptor antagonists may interfere w...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199207040-00004
更新日期:1992-07-01 00:00:00
abstract::In the US, adverse drug reactions (ADRs) rank between the fourth to sixth leading cause of death, ahead of pneumonia and diabetes mellitus. An important reason for the high incidence of serious and fatal ADRs is that the existing drug development paradigms do not generate adequate information on the mechanistic source...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200124020-00001
更新日期:2001-01-01 00:00:00
abstract::Drug eruptions are among the most common adverse drug reactions, affecting approximately 3% of hospitalised patients. Although the rate of severe cutaneous adverse reactions to medications is low, these reactions can affect anyone who takes medication, and can result in death or disability. Two general patterns can be...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200730110-00003
更新日期:2007-01-01 00:00:00
abstract::Neuropsychiatric adverse effects related to potent antiretroviral therapy are among the complications that can lead to poor adherence, treatment interruptions, or change of antiretroviral therapy regimens. For a historical perspective, we review early literature and case reports with CNS adverse effects attributed to ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200629100-00004
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND AND PURPOSE:Selective serotonin reuptake inhibitors (SSRIs) are frequently prescribed in the elderly due to a more favorable risk profile than other antidepressants (ADs). However, SSRIs are associated with an increased risk of gastrointestinal bleeding, while evidence on the risk of hemorrhagic stroke (HS) ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-019-00837-y
更新日期:2019-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Rosuvastatin is a lipid-lowering drug, the newest of a class of drugs called HMG-CoA reductase inhibitors, or 'statins', launched in the UK in March 2003. Our objective was to monitor the post-marketing safety of this drug, prescribed in primary care in England, using prescription-event monitor...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200730020-00005
更新日期:2007-01-01 00:00:00
abstract::Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.1007/s40264-017-0517-2
更新日期:2017-06-01 00:00:00
abstract:INTRODUCTION:Previously, an app has been developed for healthcare professionals (HCPs) and patients to report adverse drug reactions (ADRs) to national medicines agencies and to receive drug safety information. OBJECTIVE:This study aimed to assess (1) European HCPs' and patients' interest in an app for this two-way ri...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-018-0648-0
更新日期:2018-07-01 00:00:00
abstract:BACKGROUND:The detection of new drug safety signals is of growing importance with ever more new drugs becoming available and exposure to medicines increasing. The task of evaluating information relating to safety lies with national agencies and, for international data, with the World Health Organization Programme for I...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200023060-00004
更新日期:2000-12-01 00:00:00