Drug safety data mining with a tree-based scan statistic.

Abstract:

PURPOSE:In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Assessing an entire collection of drug-event pairs is traditionally performed on a predefined level of granularity. It is unknown a priori whether a drug causes a very specific or a set of related adverse events, such as mitral valve disorders, all valve disorders, or different types of heart disease. This methodological paper evaluates the tree-based scan statistic data mining method to enhance drug safety surveillance. METHODS:We use a three-million-member electronic health records database from the HMO Research Network. Using the tree-based scan statistic, we assess the safety of selected antifungal and diabetes drugs, simultaneously evaluating overlapping diagnosis groups at different granularity levels, adjusting for multiple testing. Expected and observed adverse event counts were adjusted for age, sex, and health plan, producing a log likelihood ratio test statistic. RESULTS:Out of 732 evaluated disease groupings, 24 were statistically significant, divided among 10 non-overlapping disease categories. Five of the 10 signals are known adverse effects, four are likely due to confounding by indication, while one may warrant further investigation. CONCLUSION:The tree-based scan statistic can be successfully applied as a data mining tool in drug safety surveillance using observational data. The total number of statistical signals was modest and does not imply a causal relationship. Rather, data mining results should be used to generate candidate drug-event pairs for rigorous epidemiological studies to evaluate the individual and comparative safety profiles of drugs.

authors

Kulldorff M,Dashevsky I,Avery TR,Chan AK,Davis RL,Graham D,Platt R,Andrade SE,Boudreau D,Gunter MJ,Herrinton LJ,Pawloski PA,Raebel MA,Roblin D,Brown JS

doi

10.1002/pds.3423

subject

Has Abstract

pub_date

2013-05-01 00:00:00

pages

517-23

issue

5

eissn

1053-8569

issn

1099-1557

journal_volume

22

pub_type

杂志文章
  • Evidence generation from healthcare databases: recommendations for managing change.

    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

    authors: Bourke A,Bate A,Sauer BC,Brown JS,Hall GC

    更新日期:2016-07-01 00:00:00

  • Mortality in schizophrenia.

    abstract::Schizophrenia is a life-threatening disease associated with mortality rates that are two to three times higher than those expected/observed in the general population. It is associated with high levels of suicide, particularly in young male patients soon after diagnosis. Delays in treating schizophrenia could contribut...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,评审

    doi:10.1002/pds.1496

    authors: Auquier P,Lançon C,Rouillon F,Lader M

    更新日期:2007-12-01 00:00:00

  • Assessing strength of evidence for regulatory decision making in licensing: What proof do we need for observational studies of effectiveness?

    abstract::Before a medicine can be recommended for a marketing authorization research must be provided to regulators that convincingly supports the benefit-risk of the product in the claimed indication. The established criteria for such research are usually expressed in terms of evidence from randomized controlled trials (RCT)....

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.5005

    authors: Slattery J,Kurz X

    更新日期:2020-10-01 00:00:00

  • Potential bias in pharmacoepidemiological studies due to the length of the drug free period: a study on antidepressant drug use in adults in the Netherlands.

    abstract:PURPOSE:The aim of this study was to evaluate the effect of the length of the drug free period on incidence measurements as well as on cohort characteristics in users of antidepressants. METHODS:The study population consisted of patients aged 18 years or older who filled a prescription for an antidepressant drug in th...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1223

    authors: Gardarsdottir H,Heerdink ER,Egberts AC

    更新日期:2006-05-01 00:00:00

  • Use of benzodiazepines in the general population and their involvement in acute self-poisoning cases.

    abstract::Benzodiazepines belong to the most widely prescribed group of drugs and are involved in a large proportion of the acute poisonings seen in emergency departments. The aim of the study was to examine whether a relationship exists between the number of poisonings with different types of benzodiazepines and the number of ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/(SICI)1099-1557(199811/12)7:6<403::AID-PDS

    authors: Verstraete AG,Buylaert WA,Blondeel L

    更新日期:1998-11-01 00:00:00

  • Preventable drug related mortality in a Swedish population.

    abstract:PURPOSE:Several studies indicate that the medical burden of fatal adverse drug reactions (FADRs) is significant, but the preventability of FADRs in the general population is largely unknown. The aim of this study was to determine the proportion of preventable FADRs and preventable fatal drug poisonings (FDPs) in a Swed...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1890

    authors: Jönsson AK,Hakkarainen KM,Spigset O,Druid H,Hiselius A,Hägg S

    更新日期:2010-02-01 00:00:00

  • Supplementary data collection with case-cohort analysis to address potential confounding in a cohort study of thromboembolism in oral contraceptive initiators matched on claims-based propensity scores.

    abstract:PURPOSE:Residual confounding is a potential limitation of pharmacoepidemiologic studies, and in particular, studies based on administrative claims data that do not capture lifestyle and clinical confounders. We describe an application of the case-cohort design to assess residual confounding by thromboembolic risk facto...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1554

    authors: Eng PM,Seeger JD,Loughlin J,Clifford CR,Mentor S,Walker AM

    更新日期:2008-03-01 00:00:00

  • Performance of a computable phenotype for identification of patients with diabetes within PCORnet: The Patient-Centered Clinical Research Network.

    abstract:PURPOSE:PCORnet, the National Patient-Centered Clinical Research Network, represents an innovative system for the conduct of observational and pragmatic studies. We describe the identification and validation of a retrospective cohort of patients with type 2 diabetes (T2DM) from four PCORnet sites. METHODS:We adapted e...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4718

    authors: Wiese AD,Roumie CL,Buse JB,Guzman H,Bradford R,Zalimeni E,Knoepp P,Morris HL,Donahoo WT,Fanous N,Epstein BF,Katalenich BL,Ayala SG,Cook MM,Worley KJ,Bachmann KN,Grijalva CG,Rothman RL,Chakkalakal RJ

    更新日期:2019-05-01 00:00:00

  • Effects of expiring reimbursability of pentaerythrityl tetranitrate (PETN, pentalong®) on anti-anginal therapy: an observational study.

    abstract:PURPOSE:Pentaerythrityl tetranitrate (PETN) was the most commonly prescribed long-acting nitrate in Germany. We aimed to assess whether the discontinuation of PETN reimbursability in 2011 resulted in alternative prescriptions of anti-anginal medications or in a discontinuation of anti-anginal therapy. METHODS:This is ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3802

    authors: Grimmsmann T,Chenot JF,Angelow A

    更新日期:2015-08-01 00:00:00

  • Factors distinguishing important identified risks from important potential risks in orphan and nonorphan drugs: An analysis of safety specifications of Japan and European Union risk management plans.

    abstract:PURPOSE:The purposes of the study are to compare safety specifications between Japan and the European Union (EU) and to identify the factors affecting categorization of important identified or potential risks. METHODS:Safety specifications were collected from orphan and nonorphan drugs approved in Japan between 2014 a...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4646

    authors: Hirota S,Yamaguchi T

    更新日期:2018-11-01 00:00:00

  • QT prolongation and torsades de pointes among methadone users: reports to the FDA spontaneous reporting system.

    abstract:BACKGROUND:Recent case series have associated the synthetic opioid, methadone, with QT prolongation and torsades de pointes (TdP) ventricular arrhythmia. STUDY OBJECTIVE:To review and analyze adverse events (QT prolongation and TdP) reported to the Food and Drug Administration (FDA) to determine the patient characteri...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1112

    authors: Pearson EC,Woosley RL

    更新日期:2005-11-01 00:00:00

  • Comparative risk of serious hypoglycemia with oral antidiabetic monotherapy: A retrospective cohort study.

    abstract:PURPOSE:To examine and compare risks of serious hypoglycemia among antidiabetic monotherapy-treated adults receiving metformin, a sulfonylurea, a meglitinide, or a thiazolidinedione. METHODS:We performed a retrospective cohort study of apparently new users of monotherapy with metformin, glimepiride, glipizide, glyburi...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4337

    authors: Leonard CE,Han X,Brensinger CM,Bilker WB,Cardillo S,Flory JH,Hennessy S

    更新日期:2018-01-01 00:00:00

  • The negative effect of red tape on research.

    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

    authors: Boshier A,Shakir SA,Telfer P,Behr E,Pakrashi T,Camm AJ

    更新日期:2005-06-01 00:00:00

  • A ranked presentation of the MHRA/CSM (Medicines & Health Care Regulatory Agency/Committee on Safety of Medicines) Drug Analysis Print (DAP) data on practolol.

    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

    authors: Mann RD

    更新日期:2005-10-01 00:00:00

  • Short-term safety and tolerability of antihypertensive agents in Korean patients: an observational study.

    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

    authors: Kim YS,Park HS,Sunwoo S,Byeon JJ,Song YM,Seo HG,Kim CH,Cheon KS,Yoo SM,Lee JK,Korea Post-Marketing Surveillance Research Group.

    更新日期:2000-12-01 00:00:00

  • The positive predictive value of a hyperkalemia diagnosis in automated health care data.

    abstract:PURPOSE:Our objectives were to determine performance of coded hyperkalemia diagnosis at identifying (1) clinically evident hyperkalemia and (2) serum potassium>6 mmol/L. METHODS:This retrospective observational study included 8722 patients with diabetes within an integrated healthcare system who newly initiated an ang...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.2030

    authors: Raebel MA,Smith ML,Saylor G,Wright LA,Cheetham C,Blanchette CM,Xu S

    更新日期:2010-11-01 00:00:00

  • Early detection of adverse drug events within population-based health networks: application of sequential testing methods.

    abstract:PURPOSE:Active surveillance of population-based health networks may improve the timeliness of detection of adverse drug events (ADEs). Active monitoring requires sequential analysis methods. Our objectives were to (1) evaluate the utility of automated healthcare claims data for near real-time drug adverse event surveil...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1509

    authors: Brown JS,Kulldorff M,Chan KA,Davis RL,Graham D,Pettus PT,Andrade SE,Raebel MA,Herrinton L,Roblin D,Boudreau D,Smith D,Gurwitz JH,Gunter MJ,Platt R

    更新日期:2007-12-01 00:00:00

  • Use of prescription medications with a potential for fetal harm among pregnant women.

    abstract:PURPOSE:To estimate the prevalence of use of prescription drugs with a potential for fetal harm among pregnant women in the United States. METHODS:A retrospective study was conducted using the automated databases of eight health maintenance organizations involved in the HMO Research Network Center for Education and Re...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1235

    authors: Andrade SE,Raebel MA,Morse AN,Davis RL,Chan KA,Finkelstein JA,Fortman KK,McPhillips H,Roblin D,Smith DH,Yood MU,Platt R,H Gurwitz J

    更新日期:2006-08-01 00:00:00

  • Practical aspects of sharing controls between case-control studies.

    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

    authors: Bunin GR,Baumgarten M,Norman SA,Strom BL,Berlin JA

    更新日期:2005-08-01 00:00:00

  • Validity and completeness of colorectal cancer diagnoses in a primary care database in the United Kingdom.

    abstract:PURPOSE:To validate the recorded diagnoses of colorectal cancer (CRC) and identify false negatives in The Health Improvement Network (THIN) primary care database. METHODS:We conducted a validation study of incident CRC cases in THIN among patients aged 40-89 years from 2000-2011. CRC Read code entries (N = 3805) were ...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3877

    authors: Cea Soriano L,Soriano-Gabarró M,García Rodríguez LA

    更新日期:2016-04-01 00:00:00

  • Risk of local adverse events by gender following cardiac catheterization.

    abstract:PURPOSE:To assess the reason for the relative high risk of local complications for women following cardiac catheterization by evaluating the associations between gender, sheath size, and local adverse outcomes following cardiac catheterization. METHODS:The data used in this study were obtained from a portion of the Am...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,多中心研究

    doi:10.1002/pds.1307

    authors: Tavris DR,Gallauresi BA,Dey S,Brindis R,Mitchel K

    更新日期:2007-02-01 00:00:00

  • Patient focused drug surveillance of elderly patients in nursing homes.

    abstract:PURPOSE:To examine whether patient focused drug surveillance was associated with a higher quality of drug treatment at nursing homes. METHODS:An intervention study in four nursing homes in Sweden and four other nursing homes served as controls. At the intervention nursing homes physicians focused on patients' health s...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1891

    authors: Olsson IN,Curman B,Engfeldt P

    更新日期:2010-02-01 00:00:00

  • Methodological considerations in assessing the effectiveness of antidepressant medication continuation during pregnancy using administrative data.

    abstract:PURPOSE:The decision whether to continue antidepressant use for depression during pregnancy requires weighing maternal and child risks and benefits. Little is known about the effectiveness of antidepressant therapy during pregnancy. The goal of this study is to evaluate whether standard administrative claims data can b...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.3798

    authors: Swanson SA,Hernandez-Diaz S,Palmsten K,Mogun H,Olfson M,Huybrechts KF

    更新日期:2015-09-01 00:00:00

  • Risk of rhabdomyolysis from 5-α reductase inhibitors.

    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

    authors: Welk B,McArthur E,Ordon M,Dirk J,Dixon S,Garg AX

    更新日期:2018-03-01 00:00:00

  • Adverse drug reactions in patients with Alzheimer's disease and related dementia in France: a national multicentre cross-sectional study.

    abstract:PURPOSE:To assess the prevalence of adverse drug reactions (ADRs) occurring in patients with Alzheimer's disease (AD) or other dementia in France. METHODS:A cross-sectional multicentre study was conducted by the French network of the 31 regional pharmacovigilance centres on a given day. The subjects were selected by r...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1002/pds.3471

    authors: Laroche ML,Perault-Pochat MC,Ingrand I,Merle L,Kreft-Jais C,Castot-Villepelet A,Durrieu G,Gras V,Guy C,Jean-Pastor MJ,Jonville-Béra AP,Merlet-Chicoine I,Miremont-Salamé G,Nourhashemi F,Charmes JP,French Centres of Pharmacov

    更新日期:2013-09-01 00:00:00

  • Preterm births and use of medication in early adulthood: a population-based registry study.

    abstract:PURPOSE:To explore associations between preterm birth and use of medications in young adulthood as a proxy for different diseases. METHODS:We linked data on birth characteristics from the Medical Birth Registry of Norway (1967-1999) and the Norwegian Prescription Database (2004-2015). Individuals born as singletons du...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4174

    authors: Engeland A,Bjørge T,Klungsøyr K,Skurtveit S,Furu K

    更新日期:2017-07-01 00:00:00

  • Association between drug-specific indicators of prescribing quality and quality of drug treatment: a validation study.

    abstract:PURPOSE:To evaluate the concurrent validity of three European sets of drug-specific indicators of prescribing quality METHODS:In 200 hip fracture patients (≥65 years), consecutively recruited to a randomized controlled study in Sahlgrenska University Hospital in 2009, quality of drug treatment at study entry was asses...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章,随机对照试验

    doi:10.1002/pds.3827

    authors: Wallerstedt SM,Belfrage B,Fastbom J

    更新日期:2015-09-01 00:00:00

  • The impact of permissive and restrictive pharmaceutical policies on quetiapine dispensing: Evaluating a policy pendulum using interrupted time series analysis.

    abstract:PURPOSE:To evaluate the impact of 2 policy changes on quetiapine dispensing in Australia: removal of prior authorisation for prescribing (policy 1: July 2007) and removal of repeat prescriptions for 25-mg quetiapine (policy 2: January 2014). METHODS:We performed an interrupted time series analysis using Pharmaceutical...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.4408

    authors: Brett J,Schaffer A,Dobbins T,Buckley NA,Pearson SA

    更新日期:2018-04-01 00:00:00

  • Modeling exposures of medications used episodically during pregnancy: Triptans as a motivating example.

    abstract:PURPOSE:To assess the validity of dispensed prescription to classify exposure to medications used episodically during pregnancy, and to explore individual trajectories of episodic medication use across pregnancy, using triptans for migraine as the motivating example. METHODS:We compared self-reported triptan use durin...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.5089

    authors: Harris GE,Wood M,Nordeng H

    更新日期:2020-09-01 00:00:00

  • Causality assessment of liver injury after chronic oral amiodarone intake.

    abstract:BACKGROUND/AIM:The number of patients receiving amiodarone will increase in future years. As clinically significant hepatotoxicity associated with oral amiodarone is infrequent and difficult to predict, a new Bayesian-developed model is proposed to help in the causality assessment of amiodarone-induced liver injury. M...

    journal_title:Pharmacoepidemiology and drug safety

    pub_type: 杂志文章

    doi:10.1002/pds.1709

    authors: Llanos L,Moreu R,Peiró AM,Pascual S,Francés R,Such J,Horga JF,Pérez-Mateo M,Zapater P

    更新日期:2009-04-01 00:00:00