Abstract:
PURPOSE:We review statistical methods for assessing the possible impact of bias due to unmeasured confounding in real world data analysis and provide detailed recommendations for choosing among the methods. METHODS:By updating an earlier systematic review, we summarize modern statistical best practices for evaluating and correcting for potential bias due to unmeasured confounding in estimating causal treatment effect from non-interventional studies. RESULTS:We suggest a hierarchical structure for assessing unmeasured confounding. First, for initial sensitivity analyses, we strongly recommend applying a recently developed method, the E-value, that is straightforward to apply and does not require prior knowledge or assumptions about the unmeasured confounder(s). When some such knowledge is available, the E-value could be supplemented by the rule-out or array method at this step. If these initial analyses suggest results may not be robust to unmeasured confounding, subsequent analyses could be conducted using more specialized statistical methods, which we categorize based on whether they require access to external data on the suspected unmeasured confounder(s), internal data, or no data. Other factors for choosing the subsequent sensitivity analysis methods are also introduced and discussed, including the types of unmeasured confounders and whether the subsequent sensitivity analysis is intended to provide a corrected causal treatment effect. CONCLUSION:Various analytical methods have been proposed to address unmeasured confounding, but little research has discussed a structured approach to select appropriate methods in practice. In providing practical suggestions for choosing appropriate initial and, potentially, more specialized subsequent sensitivity analyses, we hope to facilitate the widespread reporting of such sensitivity analyses in non-interventional studies. The suggested approach also has the potential to inform pre-specification of sensitivity analyses before executing the analysis, and therefore increase the transparency and limit selective study reporting.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Zhang X,Stamey JD,Mathur MBdoi
10.1002/pds.5117subject
Has Abstractpub_date
2020-10-01 00:00:00pages
1219-1227issue
10eissn
1053-8569issn
1099-1557journal_volume
29pub_type
杂志文章,评审abstract:BACKGROUND:Current guidelines for the empiric treatment of uncomplicated urinary tract infection in women recommend that first-line trimethoprim-sulfamethoxazole (TMP-SMX) or ofloxacin be given for 3 days and nitrofurantoin for 5 days. Increasing the duration of treatment raises costs, and perhaps, the incidence of adv...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.862
更新日期:2004-04-01 00:00:00
abstract:PURPOSE:The aims of the present study were to evaluate the use of drugs with anticholinergic properties in elderly patients and to identify risk factors that increase the patient's chance of being given such medications. METHODS:The study was performed on a sample of 1636 patients aged ≥65 years hospitalised during th...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2169
更新日期:2012-02-01 00:00:00
abstract:PURPOSE:To estimate 1-year prevalence, 1-year incidence and indication of use of antidepressant (AD) drug treatment in general practice of Southern Italy during the years 2003-2004. METHODS:Among 142,346 individuals registered in the lists of 119 general practitioners of Southern Italy, we identified users of differen...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1303
更新日期:2007-05-01 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:AIMS:To evaluate the pattern of prescribing of angiotensin-converting enzyme (ACE) inhibitors in general practice, related to the primary clinical diagnosis and concomitant medication. DESIGN:A descriptive survey of general practitioners' prescribing habits, presumptive diagnosis and patient demography over a period o...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199809/10)7:5<331::AID-PDS
更新日期:1998-09-01 00:00:00
abstract:PURPOSE:Because preapproval clinical trials typically exclude pregnant women, the evidence on drug safety during pregnancy required to inform drug labeling must come from postapproval controlled observational studies. Common designs have included pregnancy registries and case-control studies. Recently, pregnancy cohort...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4789
更新日期:2019-07-01 00:00:00
abstract:PURPOSE:The purpose of this study is to characterise how Type 2 Diabetes Mellitus (T2DM) is treated in England and Wales and whether this adheres to 2009 National Institute for Health and Care Excellence (NICE) guidance on management of T2DM. METHODS:Data for T2DM patients aged 18+ years prescribed at least one anti-d...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4092
更新日期:2017-02-01 00:00:00
abstract:PURPOSE:Case reports suggest that leukotriene modifier use may be associated with the onset of Churg-Strauss syndrome (CSS). Using pooled data from two nested case-control studies, we examined the association between asthma drug use and the development of CSS. METHODS:The study was performed in three US managed care o...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1353
更新日期:2007-06-01 00:00:00
abstract:PURPOSE:This study aimed to describe incidence, risk factors, and outcomes of warfarin-associated major bleeding (WAMB) in Thai patients. METHOD:A nested case-control study was conducted in a cohort of adult patients receiving ≥6 months of warfarin therapy who were prospectively followed up at a tertiary care hospital...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4781
更新日期:2019-07-01 00:00:00
abstract:PURPOSE:To study adult height in children that grew up with asthma before inhaled steroids became first-line therapy. METHODS:Data from the Swedish Medical Birth Register (self-reported asthma) and the Hospital Discharge Register (first hospitalization for asthma) were used, to compare adult height for asthmatic and n...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.580
更新日期:2001-03-01 00:00:00
abstract:PURPOSE:To report the use of direct oral anticoagulants (DOACs) for stroke prevention in patients with atrial fibrillation in Scotland and advocate the standardisation of drug utilisation research methods. METHODS:Retrospective cohort study using linked administrative data. Patients included those with a diagnosis of ...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4272
更新日期:2017-11-01 00:00:00
abstract::In Slovenia, the national health insurance system covers almost the whole population. The average patient receives six to seven prescriptions per year with an average value of 15 USD per prescription. This paper presents the systemic conditions necessary for the performance of pharmacoepidemiologic studies. A recent s...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.646
更新日期:2001-12-01 00:00:00
abstract:PURPOSE:To assess the feasibility of using Clinical Practice Research Datalink (CPRD) data for identifying populations of patients with chronic obstructive pulmonary disease (COPD) eligible for a hypothetical pragmatic trial. METHODS:A retrospective multidatabase cohort study using CPRD primary care and linked seconda...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.5188
更新日期:2020-12-27 00:00:00
abstract:PURPOSES:(1) Measure the prevalence of herbal product (HP) use, alone, and concomitantly with prescribed medications during pregnancy, (2) identify the most frequently consumed HP during gestation and (3) determine predictors of HP use at the beginning of pregnancy, and during the third trimester. METHODS:A questionna...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1731
更新日期:2009-06-01 00:00:00
abstract:PURPOSE:(1) To identify factors associated with the choice among the three atypical antipsychotics available in France (amisulpride, olanzapine, risperidone) and the typical antipsychotic of reference: (haloperidol), (2) to compare psychotropic co-prescription rates according to antipsychotic. METHODS:All antipsychoti...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1122
更新日期:2005-11-01 00:00:00
abstract:PURPOSE:To characterize the nature of a heparin contaminant's clinical effects in cases reported to the Adverse Event Reporting System (AERS). The FDA received reports of heparin-associated adverse events (AEs) starting in late 2007-early 2008 during a national investigation of allergic-type events. The investigation i...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1991
更新日期:2010-09-01 00:00:00
abstract:PURPOSE:To determine patterns of United Arab Emirates (UAE) citizen herbal medicine taking. METHODS:Questionnaire survey of UAE citizens attending a primary healthcare clinic in Abu Dhabi. RESULTS:Three hundred and thirty surveys were analysed. Seventy-six per cent (250/330) had previously used herbal products, and o...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1591
更新日期:2008-07-01 00:00:00
abstract:BACKGROUND:High-grade cervical dysplasia or cervical intraepithelial neoplasia grade 2 or worse has been widely used as a surrogate endpoint in cervical cancer screening or prevention trials. METHODS:To identify high-grade cervical dysplasia and cervical cancer, we developed claims-based algorithms that incorporated a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3520
更新日期:2013-11-01 00:00:00
abstract:OBJECTIVE:To identify the relevant prescribing quality domains of type 2 diabetes mellitus care as a basis for the selection of a minimal set of prescribing quality indicators from a set of previously validated indicators. METHODS:We used the principal factor analysis to identify the underlying dimensions or domains o...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2248
更新日期:2012-10-01 00:00:00
abstract:PURPOSE:Confounding, a concern in nonexperimental research using administrative claims, is nearly ubiquitous in claims-based pharmacoepidemiology studies. A fixed-length look-back window for assessing comorbidity from claims is common, but it may be advantageous to use all historical claims. We assessed how the strengt...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3922
更新日期:2016-03-01 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: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
abstract:PURPOSE:A recent regulatory warning and case reports have described the development of muscle complications with the use of 5-α reductase inhibitors (5ARIs). We wished to determine if there was a link between rhabdomyolysis and 5ARI usage. METHODS:We used a matched cohort design and linked administrative data from the...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4383
更新日期:2018-03-01 00:00:00
abstract:PURPOSE:Our study aimed to investigate the association between prenatal exposure to reactive intermediate (RI)-inducing drugs and the initiation of psychotropic medications among children. METHODS:We designed a cohort study using a pharmacy prescription database. Pregnant women were considered exposed when they receiv...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4161
更新日期:2017-03-01 00:00:00
abstract:PURPOSES:To describe the kind of the difficulties encountered when seeking research governance approval for a nationwide public health and genetic study-the Drug-Induced Arrhythmia Risk Evaluation study-in England. METHODS:Description of the processes followed when seeking research governance approval for the Drug-Ind...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.1116
更新日期:2005-06-01 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: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:Determination of the incidence rate of diabetic ketoacidosis (DKA) in type 2 diabetes mellitus (T2DM) is urgent, in response to the safety issue with use of the glucose lowering drugs, sodium-glucose cotransporter-2 inhibitors, and DKA. METHODS:We extracted data of adult patients with T2DM from a medical claim...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4271
更新日期:2018-01-01 00:00:00
abstract:PURPOSE:Three recent observational studies reported that the risk of fatal overdose is greater with venlafaxine than SSRI use. It is not clear whether patient factors could account for this finding. We evaluated whether risk factors for suicide are more prevalent among patients prescribed venlafaxine than patients pres...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1095
更新日期:2005-06-01 00:00:00
abstract:PURPOSE:Oral morphine is the first-choice opioid for moderate to severe cancer pain. Transdermal fentanyl is an alternative in patients with stable requirements of high-potency opioids (HPO) or if drugs cannot be taken orally. Drug regulatory authorities have issued several alerts to use transdermal fentanyl only for c...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2164
更新日期:2012-02-01 00:00:00