Pharmacoepidemiology and Drug Safety

Publisher: International Society for Pharmacoepidemiology; International Society of Pharmacovigilance, Wiley

Journal description

The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data methods and opinion in the emerging discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research invited reviews and a variety of guest editorials and commentaries embracing scientific medical statistical and legal aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Communication. Particular areas of interest include: design results analysis and interpretation of post-marketing surveillance and other studies looking at specific drugs populations and outcomes methods for detection and evaluation of drug-associated adverse events assessments of risk versus benefit ratios in drug therapy patterns of drug utilization relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines The Publishers recognize the need of journal users to access articles through a variety of channels and are committed to providing a wide range of options in the future. The Publishers are also aware that new communication media increase the threat to authors' own rights through unauthorized distribution alteration or attribution. To enable the Publishers to make the published version of articles available as widely as possible while protecting authors' rights to be associated with their work it is essential that a Copyright Transfer Agreement form is signed for every article which is to be considered for publication in the journal. The form can be photocopied from the journal or copies can be obtained on request from the Publisher or printed from this Web site. Inclusion of a signed form with the manuscript at the original submission stage will speed up processing and eventual publication of the article.

Current impact factor: 2.94

Impact Factor Rankings

2016 Impact Factor Available summer 2017
2014 / 2015 Impact Factor 2.939
2013 Impact Factor 3.172
2012 Impact Factor 2.897
2011 Impact Factor 2.528
2010 Impact Factor 2.339
2009 Impact Factor 2.527
2008 Impact Factor 2.516
2007 Impact Factor 2.475
2006 Impact Factor 2.155
2005 Impact Factor 1.773
2004 Impact Factor 2.098
2003 Impact Factor 1.257
2002 Impact Factor 1.092
2001 Impact Factor 1.33
2000 Impact Factor 0.867
1999 Impact Factor 0.848

Impact factor over time

Impact factor

Additional details

5-year impact 3.14
Cited half-life 5.30
Immediacy index 0.57
Eigenfactor 0.02
Article influence 1.21
Website Pharmacoepidemiology and Drug Safety website
Other titles Pharmacoepidemiology and drug safety (Online), Pharmacoepidemiology and drug safety
ISSN 1099-1557
OCLC 44084438
Material type Document, Periodical, Internet resource
Document type Internet Resource, Computer File, Journal / Magazine / Newspaper

Publisher details


  • Pre-print
    • Author can archive a pre-print version
  • Post-print
    • Author cannot archive a post-print version
  • Restrictions
    • 12 months embargo
  • Conditions
    • Some journals have separate policies, please check with each journal directly
    • On author's personal website, institutional repositories, arXiv, AgEcon, PhilPapers, PubMed Central, RePEc or Social Science Research Network
    • Author's pre-print may not be updated with Publisher's Version/PDF
    • Author's pre-print must acknowledge acceptance for publication
    • Non-Commercial
    • Publisher's version/PDF cannot be used
    • Publisher source must be acknowledged with citation
    • Must link to publisher version with set statement (see policy)
    • If OnlineOpen is available, BBSRC, EPSRC, MRC, NERC and STFC authors, may self-archive after 12 months
    • If OnlineOpen is available, AHRC and ESRC authors, may self-archive after 24 months
    • Publisher last contacted on 07/08/2014
    • This policy is an exception to the default policies of 'Wiley'
  • Classification

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: Purpose: Differential diagnostic evaluation associated with a drug may bias effect estimates because of an increased detection of preclinical outcomes. Persistent cough is a common side effect with angiotensin-converting enzyme inhibitors (ACEI), and we hypothesized that ACEI initiators would undergo more diagnostic evaluations, potentially leading to diagnosis of preclinical lung cancer. We compared the incidence of cough-related diagnostic evaluations and lung cancer among ACEI versus angiotensin receptor blockers (ARB) initiators. Methods: Using a 20% sample of Medicare claims 2007-2012, we identified initiators of ACEI or ARB, age 66-99 years. Incidence of diagnostic evaluation and lung cancer were compared using adjusted Cox models. Monthly probabilities of workup were compared using proportion differences. Results: There were 342 611 and 108 116 ACEI and ARB initiators, respectively. Monthly probability of chest X-rays ranged from minimum 4.7% to maximum 21.2% in the 6 months pre and post-initiation. Differences in incidence of diagnostic procedures in the 6 months after initiation were only minimal (chest X-rays hazard ratio (HR) = 1.12; 95% CI: 1.10-1.14), chest-MRI (0.86, 95% CI: 0.74-0.99), CT-scans (1.09, 95% CI: 0.99-1.18) or bronchoscopies (1.03, 95% CI: 0.83-1.29). Proportion differences for chest X-rays peaked in the month pre-initiation (8.4%, 95% CI: 8.1-8.6) but negligible thereafter. There was no difference in the incidence of lung cancer among ACEI versus ARB initiators (HR = 0.99, 95% CI: 0.84-1.16). Conclusion: Results indicate minimal differential chest workup after ACEI versus ARB initiation and no difference in lung cancer incidence, but suggest differential workup in the month before the first recorded prescription. The latter may reflect drug use before the first observed pharmacy claim or increased workup before initiation of ACEI therapy. Copyright © 2016 John Wiley & Sons, Ltd.
    No preview · Article · Feb 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: Purpose: Adverse drug event reports to the US Food and Drug Administration (FDA) remain the primary tool for identifying serious drug adverse effects without adequate existing warnings. We assessed the completeness of reports the FDA received in 2014. Methods: Serious adverse drug event reports were evaluated for whether they included age, gender, event date, and at least one medical term describing the event in computer excerpts. Report sources were direct reports to the FDA, manufacturer expedited reports about events without adequate warnings, and manufacturer periodic reports about events with existing warnings. Results: In 2014, the FDA received 528,192 new case reports indicating a serious or fatal outcome, 25,038 (4.7%) directly from health professionals and consumers, and 503,154 (95.3%) from drug manufacturers. Overall, 21,595 (86.2%) of serious reports submitted directly to the FDA provided data for all four completeness variables, compared with 271,022 (40.4%) of manufacturer expedited reports and 24,988 (51.3%) of periodic reports. Among manufacturer serious reports, 37.9% lacked age and 46.9% had no event date. Performance by 25 manufacturers submitting 5000 or more reports varied from 24.4% complete on all variables to 67% complete. Patient death cases had the lowest completeness scores in all categories. Conclusions: By these measures, report completeness from drug manufacturers was poor compared with direct submissions to the agency. The FDA needs to update reporting requirements and compliance policies to help industry capture better adverse event information from new forms of manufacturer interactions with health professionals and consumers. Copyright © 2016 John Wiley & Sons, Ltd.
    No preview · Article · Feb 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: Purpose: Epidemiological data on adhesion-related complications following intra-abdominal surgery are limited. We tested the accuracy of recording of these surgeries and complications within The Health Improvement Network (THIN), a primary care database within the UK. Methods: Individuals within THIN from 1995 to 2011 with an incident intra-abdominal surgery and subsequent bowel obstruction (SBO) or adhesiolysis were identified using diagnostic codes. To compute positive predictive values (PPVs), requests were sent to treating physicians of patients with these diagnostic codes to confirm the surgery, SBO, or adhesiolysis code. Completeness of recording was estimated by comparing observed surgical rates within THIN to expected rates derived from the Hospital Episode Statistics dataset within England. Cumulative incidence rates of adhesion-related complications at 5 years were compared with a previously published cohort within Scotland. Results: Two hundred seventeen of 245 (89%) questionnaires were returned (180 SBO and 37 adhesiolysis). The PPV of codes for surgery was 94.5% (95%CI: 91-97%). The 88.8% of procedure types were correctly coded. The PPV for SBO and adhesiolysis was 86.1% (95%CI: 80-91%) and 89.2% (95%CI: 75-97%), respectively. Colectomy, appendectomy, and cholecystectomy rates within THIN were 99%, 95%, and 84% of rates observed in national Hospital Episode Statistics data, respectively. Cumulative incidence rates of adhesion related complications following colectomy, appendectomy, and small bowel surgery were similar to those published previously. Conclusions: Surgical procedures, SBO, and adhesiolysis can be accurately identified within THIN using diagnostic codes. THIN represents a new tool for assessing patient-specific risk factors for adhesion-related complications and long-term outcomes. Copyright © 2016 John Wiley & Sons, Ltd.
    No preview · Article · Feb 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: Purpose: When providers recognize that patients are abusing prescription drugs, review of the drugs they are prescribed and attempts to treat the substance use disorder are warranted. However, little is known about whether prescribing patterns change following such a diagnosis. Methods: We used national longitudinal health claims data from the Market Scan® commercial claims database for January 2010-June 2011. We used a cohort of 1.85 million adults 18-64 years old prescribed opioid analgesics but without abuse diagnoses during a 6-month "preabuse" period. We identified a subset of 9009 patients receiving diagnoses of abuse of non-illicit drugs (abuse group) during a 6-month "abuse" period and compared them with patients without such a diagnosis (nonabuse group) during both the abuse period and a subsequent 6-month "postabuse" period. Results: During the abuse period 5.78% of the abuse group and 0.14% of the nonabuse group overdosed. Overdose rates declined to 2.12% in the abuse group in the postabuse period. Opioid prescribing rates declined 13.5%, and benzodiazepine rates declined 12.3% in the abuse group in the post-abuse period. Antidepressants and gabapentin were prescribed to roughly one half and one quarter of the abuse group, respectively, during all three periods. Daily opioid dosage did not decline in the abuse group following diagnosis. Conclusions: Prescribing to people who abuse drugs changes little after their abuse is documented. Actions such as tapering opioid and benzodiazepine prescriptions, maximizing alternative treatments for pain, and greater use of medication-assisted treatment such as buprenorphine could help reduce risk in this population. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.
    No preview · Article · Feb 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: Purpose: Long-acting bronchodilators, i.e. beta-2-agonists (LABA) and tiotropium are commonly used in COPD treatment. Choice of a specific agent is based on effectiveness and safety. Evidence yields controversial results with respect to mortality. The present study compared one-year mortality associated to treatment with tiotropium versus LABA. Methods: A population-based cohort study using data from Italian health information systems was performed. Patients aged 45+ years, discharged with COPD diagnosis in 2006-2009 were identified. Through record linkage with drug claims, patients who received a first prescription of LABA or tiotropium within 6 months after discharge were enrolled. The main analysis was restricted to naïve users (no prior use of either LABA or tiotropium). We used 'intention to treat' (ITT) and 'as treated' (AT) approaches. We followed patients for a maximum of 12 months. Hazard ratios (HRs) were calculated by Cox regression including quintiles of propensity score. In sensitivity analysis patients receiving tiotropium + LABA combination were included in the tiotropium group. Results: Among the 33 891 enrolees, 28% were exposed to Tio, 56% to LABA, 16% to both. Overall mean age was 74 years and the mortality rate was 122/1000 person-years (py) at the ITT analysis and 108/1000 py at the AT analysis. The adjusted HR for tiotropium only compared with LABA only was 1.06 (95%CI: 0.94-1.20) at the ITT analysis and 1.00 (95%CI: 0.93-1.08) at the AT analysis. Results were robust in sensitivity analysis. Conclusions: In this real-world study use of tiotropium was not associated with an increased risk of one-year mortality compared with LABA. © 2016 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
    No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: Pre-licensure studies have limited ability to detect rare adverse events (AEs) to vaccines, requiring timely post-licensure studies. With the increasing availability of electronic health records (EHR) near real-time vaccine safety surveillance using these data has emerged as an option. We reviewed methods currently used to inform development of similar systems for countries considering their introduction. Medline, EMBASE and Web of Science were searched, with additional searches of conference abstract books. Questionnaires were sent to organizations worldwide to ascertain unpublished studies. Eligible studies used EHR and regularly assessed pre-specified AE to vaccine(s). Key features of studies were compared descriptively. From 2779 studies, 31 were included from the USA (23), UK (6), and Taiwan and New Zealand (1 each). These were published/conducted between May 2005 and April 2015. Thirty-eight different vaccines were studied, focusing mainly on influenza (47.4%), especially 2009 H1N1 vaccines. Forty-six analytic approaches were used, reflecting frequency of EHR updates and the AE studied. Poisson-based maximized sequential probability ratio test was the most common (43.5%), followed by its binomial (23.9%) and conditional versions (10.9%). Thirty-seven of 49 analyses (75.5%) mentioned control for confounding, using an adjusted expected rate (51.4% of those adjusting), stratification (16.2%) or a combination of a self-controlled design and stratification (13.5%). Guillain-Barré syndrome (11.9%), meningitis/encephalitis/myelitis (11.9%) and seizures (10.8%) were studied most often. Near real-time vaccine safety surveillance using EHR has developed over the past decade but is not yet widely used. As more countries have access to EHR, it will be important that appropriate methods are selected, considering the data available and AE of interest. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.
    No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: Background: Synthesizing evidence from comparative effectiveness trials can be difficult because multiple outcomes of different importance are to be considered. The goal of this study was to demonstrate an approach to conducting quantitative benefit-harm assessment that considers patient preferences. Methods: We conducted a benefit-harm assessment using data from the Multicenter Uveitis Steroid Treatment Trial that compared corticosteroid implant versus systemic corticosteroids and immunosuppression in non-infectious intermediate, posterior, and panuveitis. We focused on clinical outcomes considered important to patients, including visual acuity, development of cataracts/glaucoma, need for eye surgery, prescription-requiring hypertension, hyperlipidemia, and infections. Patient preferences elicited in a recent survey were then incorporated into our assessment of the benefit-harm balance. Results: Benefit-harm metrics were calculated for each time point that summarized the numbers of outcomes, caused or prevented by implant therapy versus systemic therapy if 1000 patients were treated. The benefit-harm metric was -129 (95% confidence interval: -242 to -14), -317 (-436 to -196), -390 (-514 to -264), and -526 (-687 to -368) at 6, 12, 18, and 24 months follow up, respectively, suggesting that systemic therapy may have a better benefit-harm balance. However, measures of quality of life for patients treated with implant therapy were found to be better than patients treated with systemic therapy over the same time period. Conclusions: Results of benefit-harm assessment were different from the prospectively collected quality of life data during trial follow up. Future studies should explore the reasons for such discrepancies and the strength and weakness of each method to assess treatment benefits and harms. Copyright © 2016 John Wiley & Sons, Ltd.
    No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: Purpose: Hypnotic use might cause altered inflammatory processes, which have been suggested as being related to the mechanisms of arteriovenous fistula (AVF) failure. Therefore, we examined the association between the risk of AVF failure and hypnotic use in patients receiving hemodialysis (HD). Methods: A nested case-control study was conducted using data from the National Health Insurance Research Database of Taiwan. From 34 165 HD patients, 3676 patients receiving percutaneous transluminal angioplasty or surgical thrombectomy for AVF failure were matched to 14 704 control patients according to sex, age (±1 year), and the year of initial HD therapy. The risk of AVF failure was estimated based on conditional logistic regression after adjustment for the timing of AVF creation, HD frequency, comorbidities, and prescribed medications. Hypnotic use was measured prior to the date of AVF failure of case patients and the date of pseudo-AVF failure of controls. Results: Compared with matched controls, case patients were more likely to be exposed to hypnotics 30 days or an average daily defined dose > 0.5 within 90 days before the date of AVF failure, with an adjusted odds ratio of 1.21 (95% confidence interval [CI]: 1.09-1.35, p < 0.001) and 1.36 (95%CI: 1.13-1.63, p = 0.001), respectively. Risk of AVF failure associated with hypnotic use was also observed among HD patients who were male, were younger than 65 years, had hypertension, and did not use statins. Conclusions: Hypnotic use among HD patients was associated with an increased risk of AVF failure. Copyright © 2016 John Wiley & Sons, Ltd.
    No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety

  • No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: Purpose: During the past two decades, many novel immunosuppressive drugs have been approved for transplant recipients. Trends in the use of maintenance immunosuppressants after liver transplantation in Asia are unclear. Thus, we aimed to analyze the prescription trends in maintenance immunosuppressive drugs among liver transplant recipients in Taiwan and compare the results with the trends reported from western countries. Methods: We conducted a retrospective nationwide population-based study utilizing the National Health Insurance Research Database (NHIRD) to analyze the prescribing patterns of immunosuppressants used in Taiwanese liver transplant recipients from 2000 to 2009. Results: A total of 1686 liver transplant patients and their prescriptions of immunosuppressants were analyzed. The 5-year survival rate of liver transplant recipients was 79.6%. In 2009, the major immunosuppressive therapy among liver transplant recipients was a dual-drug regimen with tacrolimus and mycophenolic acid (57.3%). Among the calcineurin inhibitors (CNI), the use of cyclosporine decreased from 58.9% to 12.5%, while the use of tacrolimus notably increased from 23.3% to 77.5%. The use of azathioprine decreased from 21.3% to 0.4%, while the use of mycophenolic acid increased from 56.1% to 76.5%. Among the mammalian target of rapamycin (mTOR) inhibitors, sirolimus was approved in 2002, and its use increased to 8.7% in 2009. In the first 3 months after liver transplantation, a total of 17 different regimens were used in 2009, compared with seven regimens in 2000. Conclusions: Although the CNI-based combination obviously remains the major regimen, our results reveal a trend toward individualized immunosuppressive regimens among Taiwanese liver transplant recipients. Copyright © 2016 John Wiley & Sons, Ltd.
    No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety

  • No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: 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. Copyright © 2016 John Wiley & Sons, Ltd.
    No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: Purpose: There has been much controversy over the use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEIs/ARBs) on patients with renal dysfunction. The purpose of this study was to summarize the evidence regarding the effect of ACEIs/ARBs administration on mortality in patients with nondialysis-dependent chronic kidney disease (CKD) by using a meta-analytic approach. Methods: We searched the PubMed, Embase, and Web of Science databases for studies on the effect of ACEIs/ARBs administration on mortality in patients with nondialysis-dependent CKD published before March 2015. Summary effect estimates with 95% confidence intervals were derived using the random-effects model, no matter whether the heterogeneity between the included studies was of statistical significance or not. Subgroup analyses, sensitivity analyses, and publication bias tests were performed. Results: Up to 25 March 2015, 10 cohort studies were included in this meta-analysis. The hazard risk of the association between ACEIs/ARBs administration and overall mortality was 0.83 (95% confidence interval 0.78-0.87) using a random-effects model with no heterogeneity (heterogeneity test I(2) = 43.8%, p = 0.067) and publication bias (Egger's test, p = 0.763). The subgroup was divided according to estimated glomerular filtration rate, duration of follow-up, Newcastle-Ottawa Scale star, and proportion of patients with common complications including heart failure, diabetes mellitus, and hypertension. Improved survival outcomes were observed in all subgroups analysis. Sensitivity analysis proved that overall estimated effect was robust. Conclusion: This meta-analysis suggested that the use of ACEIs/ARBs in patients with nondialysis-dependent CKD was associated with improved survival. However, randomized studies are needed to confirm these findings and further establish causal relationship. Copyright © 2016 John Wiley & Sons, Ltd.
    No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: Purpose: The self-controlled (SC) designs offer the advantage of inherently controlling for time-invariant confounders, which may not be collected in electronic healthcare databases. To be valid, the design requires that some characteristics must be present. Recommendations for their use have been published in 2012, which encourage their implementation when these key characteristics are valid. We aimed at describing the potentially missed opportunities for the use of SC in pharmacoepidemiological studies on electronic healthcare databases. Methods: We searched Medline for the articles published in two different 6-month periods before and after the 2012 recommendations. The potentially opportunity for the use of SC design is based on major required characteristics (abrupt onset event, rare or recurrent event, and acute or intermittent exposure). Results: In total, 94 papers in 2011 were analysed and 106 in 2014. SC designs were rarely used (2% in 2011 and 1% in 2014). A potentially missed opportunity for SC use was found in 16% of papers in 2011 and 15% in 2014. Conclusions: We found that SC designs were underused and identified situations in which they could have been applied, but were not. Their use should be encouraged.
    No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: Purpose: This study examined the accuracy of claims-based algorithms to identify smoking against self-reported smoking data. Methods: Medicare patients enrolled in the Brigham and Women's Hospital Rheumatoid Arthritis Sequential Study were identified. For each patient, self-reported smoking status was extracted from Women's Hospital Rheumatoid Arthritis Sequential Study and the date of this measurement was defined as the index-date. Two algorithms identified smoking in Medicare claims: (i) only using diagnoses and procedure codes and (ii) using anti-smoking prescriptions in addition to diagnoses and procedure codes. Both algorithms were implemented: first, only using 365-days pre-index claims and then using all available pre-index claims. Considering self-reported smoking status as the gold standard, we calculated specificity, sensitivity, positive predictive value, negative predictive value (NPV), and area under the curve (AUC). Results: A total of 128 patients were included in this study, of which 48% reported smoking. The algorithm only using diagnosis and procedure codes had the lowest sensitivity (9.8%, 95%CI 2.4%-17.3%), NPV (54.9%, 95%CI 46.1%-63.9%), and AUC (0.55, 95%CI 0.51-0.59) when applied in the period of 365 days pre-index. Incorporating pharmacy claims and using all available pre-index information improved the sensitivity (27.9%, 95%CI 16.6%-39.1%), NPV (60.4%, 95%CI 51.3%-69.5%), and AUC (0.64, 95%CI 0.58-0.70). The specificity and positive predictive value was 100% for all the algorithms tested. Conclusion: Claims-based algorithms can identify smokers with limited sensitivity but very high specificity. In the absence of other reliable means, use of a claims-based algorithm to identify smoking could be cautiously considered in observational studies. Copyright © 2016 John Wiley & Sons, Ltd.
    No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety
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    ABSTRACT: Background/purpose: Because ankylosing spondylitis (AS) is uncommon, large medical record databases offer important opportunities for pharmacoepidemiologic research. However, the validity of AS diagnoses recorded by a general practitioner (GP) is unknown. We assessed the validity of algorithms for identifying AS in The Health Improvement Network (THIN). Methods: THIN is a database of GP records for over 10 million persons in the UK. In 2014, we administered a questionnaire to GPs of 100 adults for whom an AS diagnosis had been recorded. As high positive predictive value (PPV) is critically important in AS research, we sought to determine the PPV of an AS diagnostic code relative to the GP's clinical impression as the gold standard. Other AS algorithms included: more than one AS diagnostic code, prescription of a nonsteroidal anti-inflammatory drug (NSAID), disease modifying anti-rheumatic drug (DMARD) or biologic. Results: In 61 of 85 returned questionnaires, the GP's clinical impression confirmed AS yielding an overall PPV of 72%. PPV was 89% for two AS codes >7 days apart, and was 86% for an AS code plus a DMARD/biologic. Sensitivity was reduced with algorithms requiring two AS codes (64%) and a DMARD/biologic prescription (30%). Algorithms requiring prescription of an NSAID, or the absence of OA or RA had lower PPV (71-75%) and higher sensitivity (95-98%). Conclusion: An AS identification algorithm of two AS diagnoses separated by >7 days provided the highest PPV. This algorithm should be used for pharmacoepidemiologic studies in THIN. Copyright © 2016 John Wiley & Sons, Ltd.
    No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety

  • No preview · Article · Jan 2016 · Pharmacoepidemiology and Drug Safety