PROTECT: Work Package 6 PROTECT: An Innovative Public-Private Partnership for New Methodologies in Pharmacovigilance and Pharmacoepidemiology
|
|
|
- Jasmine Carr
- 6 years ago
- Views:
Transcription
1 PROTECT: Work Package 6 PROTECT: An Innovative Public-Private Partnership for New Methodologies in Pharmacovigilance and Pharmacoepidemiology Lamiae Grimaldi (LA-SER) & Stéphanie Tcherny-Lessenot (sanofi R&D) London, February 2015
2 WP6 Participants of WP2 replicability research plan Institutions LASER Sanofi Research and Development European Medicines Agency Takeda Global Research and Development Centre (Europe) Ltd Universiteit Utrecht Aarhus University Names Lucien Abenhaim (WP Co-leader), Lamiae Grimaldi (WP co-leader alternate) Laurent Auclert (WP Co-leader-left in June14), Juhaeri Juhaeri (WP co-leader (alternate)), Stéphanie Tcherny- Lessenot (WP co-leader alternate) Laurence Mazuranok (WP Project Manager) Xavier Kurz Lesley Wise, David Irvine, Paul Dolin Marieke De Bruin, Ines Teixidor Christiane Gasse 2
3 Work Package 6 Specific objectives To validate and test the transferability and feasibility of methods developed in PROTECT (WP2 to 5) to other data sources and population groups To determine the added value of using other data sources as a supplement or alternative to those generally used for drug safety studies, in order to investigate specific aspects or issues. Started in September 2010 (Year 2) 3
4 WP2 Replicability research plan: Study Objectives, Rationale and Design Research plan designed from defined study objectives applied to WP2 drug-event pairs - Replication in same database - Replication in different database - Negative control study - Use of alternative outcome definition - Validation of outcome - Assessment of confounders Key principles - Common protocol applied for each drug pair event - Blinding procedure 4
5 WP2 Replicability research plan: Study Objectives, Rationale and Design Defined Study Objective Objective 1 Replication study in same database Scientific Question Is the study replicable when conducted independently in the same database? DB identification CPRD Danish Psychiatric, Somatic Hospital Discharge & Mortality Registers (DMR) Study design Cohort study Objective 2 Replication study in different database Do the results have external validity? LabRx/Premier MarketScan and Medicare E3N PGRx UPOD Nested case control Population case control Cohort Descriptive study 5
6 WP2 Replicability research plan: Study Objectives, Rationale and Design Defined Study Objective Objective 3 Negative control study Objective 4 Use of alternative outcome definition Scientific Question Does a study using the same protocol provide absence of evidence of an association where the exposure is such that the expected result is one of no association? What is the impact of different levels of certainty of the outcome (e.g. definite, probable, possible) on the effect estimate? DB identification LabRx/Premier PGRx GPRD PGRx DMR Study design Nested case control (AMI) Population case control Population case control 6
7 WP2 Replicability research plan: Study Objectives, Rationale and Design Defined Study Objective Scientific Question DB identification Study design Objective 5 Validation of outcome Objective 6 Assessment of confounders Has the outcome of interest been validated through clinical record review? What is the impact of validation on the effect estimate? Has confounding been adequately taken into consideration? Are there additional confounders that need to be assessed? How does better control for confounding impact the effect estimate? GPRD LabRx/Premier UPOD DMR CPRD UPOD PGRx DMR Population case control Nested case control Cohort study Descriptive study Population case control Cohort study 7
8 Antibiotics and acute liver injury (ALI) Used for replication in the same database, assessment of alternate definition (CPRD) Used for replication in another database (Clinformatics) Used for validation of outcomes: UPOD UPOD (WP6) and BIFAP (WP2) used validated cases (definite validated cases in BIFAP and broad validated cases in UPOD) 8
9 OR adj and 95% CI Adjusted odds ratios of ALI associated with current antibiotic use across databases according to case definitions Original Replica on Original Replica on BIFAP broad validated (n=436) BIFAP definite validated (n=124) UPOD broad (n=80) UPOD broad validated (n=20)** CPRD original broad (n=997) CPRD original definite (n=265) CPRD replica on broad (n=5431) CPRD replica on definite (n=1367) Clinforma cs broad (n=5145) Clinforma cs definite (n=753) 9
10 Adjusted odds ratios of definite cases** of ALI associated OR adj and 95% CI with antibiotic use across databases and different definitions of time window at risk 12.0 Original Replica on BIFAP 30 days BIFAP 14 days CPRD (original) 30 days CPRD (original) 14 days CPRD (replica on) 30 days CPRD (replica on) 21 days CPRD (replica on) 14 days Clinforma cs 30 days Clinforma cs 14 days UPOD 30 days UPOD 14 days 10
11 Beta2 agonists and myocardial infarction Used as replication in another database PGRx Clinformatics 11
12 Results: Beta2 agonists & AMI Drug-event pair Database Design Status Who? Beta2 agonists & AMI PGRx Case-control Completed LASER LabRx Cohort Completed Sanofi Exposure to Beta2 agonists PGRx 2 months before index date Crude OR (95% CI) Adjusted OR (95% CI) Exposure in this time window 1.23 ( ) 1.19 ( ) 12 months before index date Exposure in this time window 1.14 ( ) 1.01 ( ) LabRx Cohort 325,377 Crude HR Adjusted HR Current users of LABA 1.09 ( ) 0.93 ( ) Recent (90 days) 1.30 ( ) 1.26 ( ) 12
13 Antibiotics and acute myocardial infarction (AMI) Used as an exercice around negative control using case-control design PGRx Clinformatics 13
14 Results: Antibiotics and AMI (negative control) Drug-event pair Database Design Status Who? LabRx Case-control Completed Sanofi Antibiotics and AMI PGRx Case-control Completed LASER Exposure to antibiotics PGRx Crude OR (95% CI) Adjusted OR (95% CI) 2 months before index date Exposure in this time window 1.22 ( ) 1.24 ( ) 12 months before index date Exposure in this time window 1.07 ( ) 1.06 ( ) LabRx 2 months before index date Exposure in this time window 1.45 ( ) 1.35 ( ) 12 months before index date Exposure in this time window 1.25 ( ) 1.13 ( ) 14
15 Antiepileptics and suicidality Used as replication in the same database and validation of outcome (Danish register) Used as replication in another database, use of alternate definition (PGRx) 15
16 Results: Antiepileptic & Suicidality Drug-event pair Database Design Status Who? Antiepileptic & Suicidality Danish register Cohort Completed AU PGRx Case-control Completed LASER Exposure to antiepileptic drugs PGRx 2 months before index date Crude OR (95% CI) Adjusted OR (95% CI) Exposure in this time window 3.10 ( ) 1.98 ( ) 12 months before index date Exposure in this time window 3.08 ( ) 1.85 ( ) Danish Registry (Carbamazepine) Crude HRR Standard covariate adjustment Cohort study (N=43,035) (IR current/ir past ) HRR (95% CI) Current use ( ) CPRD (Carbamazepine) (N=46,364) Current use ( ) 16
17 Results: Comparison of cases and controls by exposure to antiepileptic drugs according to current depression episode Patients with current major depressive episode Patients without current depression 2-month time window Cases (n=298) Controls (n=249) Cases (n=163) Controls (n=2202) n (%) n (%) Adj OR [95%CI] n (%) n (%) Adj OR [95%CI] Use of any AED (vs. none) 31 (10.4) 14 (6.3) 2.2 [ ] 8 (4.9) 64 (2.6) 1.4 [ ] 12-month time window Use of any AED (vs. none) 41 (13.8) 19 (8.1) 2.2 [ ] 10 (6.1) 79 (3.3) 1.3 [ ] Among those with depression, cases were more than twice as likely to be exposed to any AEDs than controls, whereas no difference observed in those without depression
18 esults: Comparison of cases and controls by exposure to antiepileptic drugs according to the presence of a neurologic condition* Patients with a neurologic condition * Patients without any neurologic condition* 2-month time window Cases (n=89) Controls (n=201) n (%) n (%) Adj OR [95%CI] Cases (n=417) Controls (n=2628) n (%) n (%) Adj OR [95%CI] Use of any AED (vs. none) 15 (16.9) 38 (18.1) 1.2 [ ] 29 (7.0) 53 (1.8) 3.1 [ ] 12-month time window Use of any AED (vs. none) 17 (19.1) 39 (18.2) 1.3 [ ] 39 (9.4) 74 (2.6) 3.0 [ ] 12-month time window Use of any AED (except clonazepam only) (vs. none) (1.9) 42 (1.6) 1.0 [ ] *Epilepsy, migraine, chronic neuropathic pain
19 WP2 Replicability research plan: Conclusions Defined Study Objective Objective 1 Replication study in same database Conclusion Case control analysis of ATB & ALI, replicated in the CPRD same point estimates, different CI due to fewer cases retained The study is replicable when conducted independently in the same database Objective 2 Replication study in different database 2 drug-event pairs: ATB & ALI and β2agonists & AMI Replication in different databases with different methods (using the same protocol for each method) Point estimates very consistent with each other Results have an external validity 19
20 WP2 Replicability research plan: Conclusions Defined Study Objective Objective 3 Negative control study Conclusion Case control analysis of ATB & AMI Similar trend towards an increased risk of AMI in recent antibiotic users (one significant and the other NS): true negative? Interpretation with caution Objective 4 Use of alternative outcome definition Misclassification / case definition In the case of ATB&ALI: point estimate increased with more precise definitions for non validated cases 20
21 WP2 Replicability research plan: Conclusions Defined Study Objective Objective 5 Validation of outcome Conclusion - Few cases left after validation - Analysis not possible Objective 6 Assessment of confounders -Antiepileptic drugs and SA: taking into account confounding by indication showed large differences in results - Otherwise generally minimal effect. 21
Comparative analyses of Drug- Adverse Event Associations in Various European Databases
Comparative analyses of Drug- Adverse Event Associations in Various European Databases First results from PROTECT WP2-WG1 ISPE Mid-Year Meeting, Munich, 12-Apr-2013 Raymond G. Schlienger, PhD, MPH. Global
OBSERVATIONAL MEDICAL OUTCOMES PARTNERSHIP
OBSERVATIONAL Patient-centered observational analytics: New directions toward studying the effects of medical products Patrick Ryan on behalf of OMOP Research Team May 22, 2012 Observational Medical Outcomes
Embedding pragmatic trials within databases of electronic health records / disease registries Tjeerd van Staa
Embedding pragmatic trials within databases of electronic health records / disease registries Tjeerd van Staa London School of Hygiene & Tropical Medicine Utrecht University The big-data revolution in
Study Exposures, Outcomes:
GSK Medicine: Coreg IR, Coreg CR, and InnoPran Study No.: WWE111944/WEUSRTP3149 Title: A nested case-control study of the association between Coreg IR and Coreg CR and hypersensitivity reactions: anaphylactic
THIS TALK STATINS REDUCE: Immortal time bias Immeasurable time bias Time-window bias TIME-RELATED BIASES IN PHARMACOEPIDEMIOLOGY
TIME-RELATED BIASES IN PHARMACOEPIDEMIOLOGY Samy Suissa McGill University and Jewish General Hospital Montreal, Canada ISPE mid-year meeting, Miami April 22, 2012 STATINS REDUCE: JAMA 2000: Fracture rate
Bias and confounding special issues. Outline for evaluation of bias
EPIDEMIOLOGI BIAS special issues and discussion of paper April 2009 Søren Friis Institut for Epidemiologisk Kræftforskning Kræftens Bekæmpelse AGENDA Bias and confounding special issues Confounding by
Visualizing Uncertainty among laypersons and experts
Visualizing Uncertainty among laypersons and experts PROTECT SYMPOSIUM 20 February 2015 Andrea Beyer Phd Contents Background Study objectives Study design Recruitment challenges and results Preliminary
DECLARATION OF CONFLICT OF INTEREST
DECLARATION OF CONFLICT OF INTEREST Warfarin and the risk of major bleeding events in patients with atrial fibrillation: a population-based study Laurent Azoulay PhD 1,2, Sophie Dell Aniello MSc 1, Teresa
Long-Term Use of Long-Acting Insulin Analogs and Breast Cancer Incidence in Women with Type 2 Diabetes.
Long-Term Use of Long-Acting Insulin Analogs and Breast Cancer Incidence in Women with Type 2 Diabetes. Wu, J. W., Azoulay, L., Majdan, A., Boivin, J. F., Pollak, M., and Suissa, S. Journal of Clinical
Self-controlled case-series method
Self-controlled case-series method Presented by StellaMay Gwini Biostatistical Consultancy Platform, DEPM Objectives To describe the self-controlled case-series method Highlight possible uses of SCCS within
Boehringer Ingelheim Page 6 of 178 Study report for non-interventional studies based on existing data BI Study Number
Page 6 of 178 report for non-interventional studies based on existing data BI Number 1160.144 c14462719-01 International GmbH or one or more of its affiliated companies 1. ABSTRACT Title of study: Keywords:
CAN EFFECTIVENESS BE MEASURED OUTSIDE A CLINICAL TRIAL?
CAN EFFECTIVENESS BE MEASURED OUTSIDE A CLINICAL TRIAL? Mette Nørgaard, Professor, MD, PhD Department of Clinical Epidemiology Aarhus Universitety Hospital Aarhus, Denmark Danish Medical Birth Registry
Supplementary Appendix
Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Svanström H, Pasternak B, Hviid A. Use of azithromycin and
Using negative control outcomes to identify biased study design: A self-controlled case series example. James Weaver 1,2.
Using negative control outcomes to identify biased study design: A self-controlled case series example James Weaver 1,2 1Janssen Research & Development, LLC, Raritan, NJ, USA 2 Observational Health Data
Executive Summary Report on Rates and Relative Risks by Individual Drug
Safety Evaluation of Adverse Reactions in Diabetes HEALTH-282521 Executive Summary Report on Rates and Relative Risks by Individual Drug Author(s): SA Romio (EMC), I. Leal (EMC), G Masclee (EMC), P Rijnbeek
Outcomes: Initially, our primary definitions of pneumonia was severe pneumonia, where the subject was hospitalized
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
Propensity scores and instrumental variables to control for confounding. ISPE mid-year meeting München, 2013 Rolf H.H. Groenwold, MD, PhD
Propensity scores and instrumental variables to control for confounding ISPE mid-year meeting München, 2013 Rolf H.H. Groenwold, MD, PhD WP2 WG2: aims Evaluate methods to control for observed and unobserved
Measuring drug exposure: rationale and methods
Measuring drug exposure: rationale and methods Hubert G. Leufkens Declaration of interests Chairman of the Dutch Medicines Evaluation Board (MEB), since mid 2007. Professor of Pharmacoepidemiology, Utrecht
Management of patients with should not use past or present history of solid cancer
Practical management of patients receiving abatacept 1 Management of patients with should not use past or present history of solid Evidence-based Medicine Official Recommendations Expert opinion Steps
Tuning Epidemiological Study Design Methods for Exploratory Data Analysis in Real World Data
Tuning Epidemiological Study Design Methods for Exploratory Data Analysis in Real World Data Andrew Bate Senior Director, Epidemiology Group Lead, Analytics 15th Annual Meeting of the International Society
Varenicline and cardiovascular and neuropsychiatric events: Do Benefits outweigh risks?
Varenicline and cardiovascular and neuropsychiatric events: Do Benefits outweigh risks? Sonal Singh M.D., M.P.H, Johns Hopkins University Presented by: Sonal Singh, MD MPH September 19, 2012 1 CONFLICTS
1.1. Tamsulosin and depressive reactions
1.1. and depressive reactions Introduction (Omnic ) is an adrenergic alpha1-receptor (alpha1-ar) blocker. It is registered for the treatment of lower urinary tract symptoms (LUTS) related to benign prostatic
Research activities within PROTECT. Luisa Ibáñez
Research activities within PROTECT Luisa Ibáñez PROTECT Work Package 2 Working Group 3 PROTECT: Pharmacoepidemiological Research on Outcome of Therapeutics by a European ConsorTium PROTECT Project organization
Use of a-blockers and the risk of hip/femur fractures
Journal of Internal Medicine 2003; 254: 548 554 Use of a-blockers and the risk of hip/femur fractures P. C. SOUVEREIN 1,T.P.VANSTAA 1,2,A.C.G.EGBERTS 1,J.J.M.C.H.DELAROSETTE 3, C. COOPER 2 & H. G. M. LEUFKENS
PFIZER INC. What is the difference in incidence of fracture in women who ever or never used DMPA for contraception?
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
Presenter Disclosure Information
Presenter Disclosure Information Soko Setoguchi, MD DrPH Prescription Drug Data: Advantages, Availability, and Access FINANCIAL DISCLOSURE: Grants/Research Support: NIH, AHRQ UNLABELED/UNAPPROVED USES
GSK Medicine: salmeterol, Salmeterol+Fluticasone proprionate, fluticasone propionate, beclomethasone
GSK Medicine: salmeterol, Salmeterol+Fluticasone proprionate, fluticasone propionate, beclomethasone Study No.: WWE111984/WEUSRTP2640/EPI40528 Title: The Asthma Death Case Control Study (ADCCS): Association
Infections and autoimmunity as risk factors for mental disorders
Common threads New York March 2018 Infections and autoimmunity as risk factors for mental disorders - Danish nationwide register and biobank studies M.D., Ph.D. The Danish Registers Prescription Database
The diffusion of cardiac implantable electrical devices in Europe: what drives the differences?
FINAL CONFERENCE Milan, November 13 th 2015 The diffusion of cardiac implantable electrical devices in Europe: what drives the differences? Aleksandra Torbica, Helen Banks, Giuseppe Boriani, Cinzia Valzania,
The journey toward Clinical Characterization. Patrick Ryan, PhD Janssen Research and Development Columbia University Medical Center
The journey toward Clinical Characterization Patrick Ryan, PhD Janssen Research and Development Columbia University Medical Center Odyssey (noun): \oh-d-si\ 1. A long journey full of adventures 2. A series
Infections and autoimmunity as risk factors for mental disorders
C O M M O N T h r e a d s N e w Yo r k M a r c h 2 0 1 8 Infections and autoimmunity as risk factors for mental disorders - Danish nationwide register and biobank studies M.D., Ph.D. Copenhagen University
Evolution of Active Surveillance: An Industry Perspective
Evolution of Active Surveillance: An Industry Perspective Midwest Biopharmaceutical Statistics Workshop May 21, 2013 Stephen Motsko, PharmD, PhD Ken Hornbuckle, DVM, PhD Office of Risk Management and Pharmacoepidemiology
Supplementary Online Content
Supplementary Online Content Raguideau F, Lemaitre M, Dray-Spira R, Zureik M. Association between oral fluoroquinolone use and retinal. JAMA Ophthalmol. Published online March 10, 2016. doi:10.1001/jamaophthalmol.2015.6205.
Manuscript ID BMJ entitled "Benzodiazepines and the Risk of Allcause Mortality in Adults: A Cohort Study"
12-Jan-2017 Dear Dr. Patorno Manuscript ID BMJ.2016.036319 entitled "Benzodiazepines and the Risk of Allcause Mortality in Adults: A Cohort Study" Thank you for sending us your paper. We sent it for external
Improved Transparency in Key Operational Decisions in Real World Evidence
PharmaSUG 2018 - Paper RW-06 Improved Transparency in Key Operational Decisions in Real World Evidence Rebecca Levin, Irene Cosmatos, Jamie Reifsnyder United BioSource Corp. ABSTRACT The joint International
Strategies for data analysis: case-control studies
Strategies for data analysis: case-control studies Gilda Piaggio UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction World Health Organization
levetiracetam 250,500,750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra ) (No. 397/07) UCB Pharma Ltd
Scottish Medicines Consortium Resubmission levetiracetam 250,500,750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra ) (No. 397/07) UCB Pharma Ltd 11 January 2008 The Scottish Medicines
Critical Appraisal of a Meta-Analysis: Rosiglitazone and CV Death. Debra Moy Faculty of Pharmacy University of Toronto
Critical Appraisal of a Meta-Analysis: Rosiglitazone and CV Death Debra Moy Faculty of Pharmacy University of Toronto Goal To provide practitioners with a systematic approach to evaluating a meta analysis
CAH Participation and Quality Measure Results for Hospital Compare 2007 Discharges and Trends: National and North Carolina Results
January 2009 CAH Participation and Quality Measure Results for Hospital Compare Discharges and - Trends: and Results Michelle Casey, MS 1, Michele Burlew, MS 2, Ira Moscovice, PhD 1 1 University of Minnesota
Danish population-based registries in cancer pharmacoepidemiology. Cancer Pharmacoepidemiology Meeting Dublin September 2013
Danish population-based registries in cancer pharmacoepidemiology Deirdre Cronin Fenton dc@dce.au.dk Cancer Pharmacoepidemiology Meeting Dublin September 2013 Frank L. Science 2003 The Danish Cohort The
Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year. Risk of seizures associated with Ranolazine (Ranexa)
Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year Risk of seizures associated with Ranolazine (Ranexa) Efe Eworuke, PhD Division of Epidemiology Office of Pharmacovigilance
New Technologies and Analytic Techniques for Dietary Assessment
New Technologies and Analytic Techniques for Dietary Assessment Amy F. Subar, PhD, MPH, RD US National Cancer Institute Division of Cancer Control and Population Sciences Risk Factor Monitoring and Methods
Downloaded from:
Korhonen, P; Heintjes, EM; Williams, R; Hoti, F; Christopher, S; Majak, M; Kool-Houweling, L; Strongman, H; Linder, M; Dolin, P; Bahmanyar, S (2016) Pioglitazone use and risk of bladder cancer in patients
Post-diagnosis NSAID use and risk of contralateral breast cancer
Post-diagnosis NSAID use and risk of contralateral breast cancer a Danish nationwide cohort study Annet Bens 1, Søren Friis 1,2, Deidre Cronin-Fenton 3, Christian Dehlendorff 1, Maj-Britt Jensen 4, Bent
Fran Cunningham, Pharm.D. Director, Center for Medication Safety PSCI Program Manager Pharmacoepidemiologic/ Outcomes Assessment Department of
Fran Cunningham, Pharm.D. Director, Center for Medication Safety PSCI Program Manager Pharmacoepidemiologic/ Outcomes Assessment Department of Veterans Affairs PBM Services Overview of Pharmacovigilance
Large scale analytics for electronic health records: Lessons from Observational Health Data Science and Informatics (OHDSI)
Large scale analytics for electronic health records: Lessons from Observational Health Data Science and Informatics (OHDSI) Patrick Ryan, PhD on behalf of OHDSI team 15 November 2016 Odyssey (noun): \oh-d-si\
Sanofi Announces Results of ORIGIN, the World s Longest and Largest Randomised Clinical Trial in Insulin in Pre- and Early Diabetes
PRESS RELEASE Sanofi Announces Results of ORIGIN, the World s Longest and Largest Randomised Clinical Trial in Insulin in Pre- and Early Diabetes Dublin, Ireland (15 June 2012) Sanofi presented results
Incorporating Clinical Information into the Label
ECC Population Health Group LLC expertise-driven consulting in global maternal-child health & pharmacoepidemiology Incorporating Clinical Information into the Label Labels without Categories: A Workshop
Dabigatran Evidence in Real Practice
ADVANCES IN CARDIAC ARRHYTHMIAS and GREAT INNOVATIONS IN CARDIOLOGY XXVII GIORNATE CARDIOLOGICHE TORINESI Torino, Centro Congressi Unione Industriale 23-24 Ottobre 2015 Dabigatran Evidence in Real Practice
RETROSPECTIVE CLAIMS DATABASE STUDIES OF DIRECT ORAL ANTICOAGULANTS (DOACS) FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION
RETROSPECTIVE CLAIMS DATABASE STUDIES OF DIRECT ORAL ANTICOAGULANTS (DOACS) FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION Craig I. Coleman, PharmD Professor, University of Connecticut School
Validity of data sources in pharmacoepidemiology
Validity of data sources in pharmacoepidemiology Jesper Hallas MD DrMedSc Dept of clinical pharmacology University of Southern Denmark, Odense jhallas@health.sdu.dk Disposition 1. Defining validity 2.
RESEARCH. Katrina Wilcox Hagberg, 1 Hozefa A Divan, 2 Rebecca Persson, 1 J Curtis Nickel, 3 Susan S Jick 1. open access
open access Risk of erectile dysfunction associated with use of 5-α reductase inhibitors for benign prostatic hyperplasia or alopecia: population based studies using the Clinical Practice Research Datalink
The STOP Measure. Safe and Transparent Opioid Prescribing to Promote Patient Safety and Reduced Risk of Opioid Misuse FEBRUARY 2018
The STOP Measure Safe and Transparent Opioid Prescribing to Promote Patient Safety and Reduced Risk of Opioid Misuse FEBRUARY 2018 AHIP s Safe, Transparent Opioid Prescribing (STOP) Initiative Methodology
Surgical Outcomes: A synopsis & commentary on the Cardiac Care Quality Indicators Report. May 2018
Surgical Outcomes: A synopsis & commentary on the Cardiac Care Quality Indicators Report May 2018 Prepared by the Canadian Cardiovascular Society (CCS)/Canadian Society of Cardiac Surgeons (CSCS) Cardiac
Comprehensive Research Plan: Inhaled corticosteroids + long-acting beta agonists (ICS+LABA) for the treatment of asthma
Comprehensive Research Plan: Inhaled corticosteroids + long-acting beta agonists (ICS+LABA) for the treatment of asthma Pharmacoepidemiology Unit July 10, 2014 30 Bond Street, Toronto ON, M5B 1W8 www.odprn.ca
GSK Clincal Study Register
In February 2013, GlaxoSmithKline (GSK) announced a commitment to further clinical transparency through the public disclosure of GSK Clinical Study Reports (CSRs) on the GSK Clinical Study Register. The
OBSERVATIONAL MEDICAL OUTCOMES PARTNERSHIP
An empirical approach to measuring and calibrating for error in observational analyses Patrick Ryan on behalf of the OMOP research team 25 April 2013 Consider a typical observational database study: Exploring
Michael Etrata Rañopa. September Department of Non-communicable Disease Epidemiology. Faculty of Epidemiology and Population Health
Methodological issues in electronic healthcare database studies of drug cancer associations: identification of cancer, and drivers of discrepant results Michael Etrata Rañopa Thesis submitted in accordance
2. Studies of Cancer in Humans
346 IARC MONOGRAPHS VOLUME 72 2. Studies of Cancer in Humans 2.1 Breast cancer 2.1.1 Results of published studies Eight studies have been published on the relationship between the incidence of breast cancer
The use of prescription databases for the study of prescription drug abuse: Prescriptions of Benzodiazepines in Denmark
The use of prescription databases for the study of prescription drug abuse: hstovring@health.sdu.dk Research Unit of General Practice University of Southern Denmark Prescription Drug Abuse Conference,
Challenges in design and analysis of large register-based epidemiological studies
FMS/DSBS autumn meeting 2014 Challenges in design and analysis of large register-based epidemiological studies Caroline Weibull & Anna Johansson Department of Medical Epidemiology and Biostatistics (MEB)
Classification of exposure and outcome
Patrick Souverein PhD Utrecht Institute for Pharmaceutical Sciences, Utrecht University EAHP Prague 13 Sept 2014 Conflict of Interest Patrick Souverein has received unrestricted funding from the private-public
Case-Control Studies
Case-Control Studies Marc Schenker M.D., M.P.H Dept. of Public Health Sciences UC Davis Marc Schenker M.D., M.P.H, UC Davis 1 Case-Control Studies OBJECTIVES After this session, you will be familiar with:
Epidemiologic study designs
Epidemiologic study designs and critical appraisal of scientific papers Rolf H.H. Groenwold, MD, PhD Bio sketch MD, PhD in epidemiology Associate professor of Epidemiology at UMC Utrecht Research focus
Drug Utilisation Study Evaluation of the Use of Nepafenac in Selected European Populations. Study Core Protocol Summary
Drug Utilisation Study Evaluation of the Use of Nepafenac in Selected European Populations Study Core Protocol Summary ABSTRACT Title Evaluation of the Use of Nepafenac in Selected European Populations
Supplementary Methods
Supplementary Materials for Suicidal Behavior During Lithium and Valproate Medication: A Withinindividual Eight Year Prospective Study of 50,000 Patients With Bipolar Disorder Supplementary Methods We
Adverse Outcomes After Hospitalization and Delirium in Persons With Alzheimer Disease
Adverse Outcomes After Hospitalization and Delirium in Persons With Alzheimer Disease J. Sukanya 05.Jul.2012 Outline Background Methods Results Discussion Appraisal Background Common outcomes in hospitalized
exp neoplasms/ OR cancer*.mp. OR neoplasm*.mp. OR 3,363,037 Publication type: observational studies (cohorts and case-controls)
Supplementary Table S1. Search strategy for observational studies on long-acting insulin analogues and cancer using Medline and Embase databases from January 2000 to October 8, 2014 Medline Description
A Method to Combine Signals from Spontaneous Reporting Systems and Observational Healthcare Data to Detect Adverse Drug Reactions
Drug Saf (2015) 38:895 908 DOI 10.1007/s40264-015-0314-8 ORIGINAL RESEARCH ARTICLE A Method to Combine Signals from Spontaneous Reporting Systems and Observational Healthcare Data to Detect Adverse Drug
This is the publisher s version. This version is defined in the NISO recommended practice RP
Journal Article Version This is the publisher s version. This version is defined in the NISO recommended practice RP-8-2008 http://www.niso.org/publications/rp/ Suggested Reference Chong, J., Karner, C.,
Strategies for data analysis: I. Observational studies
Strategies for data analysis: I. Observational studies Gilda Piaggio UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction World Health Organization
. 10. Hydration and nutrition 10.2 Assessment of swallowing function
. 10. Hydration and nutrition 10.2 Assessment of swallowing function NUTRI 1b: In patients with acute, what is the accuracy of a) bedside swallowing assessment b) video fluoroscopy c) fiberoptic endoscopic
Visualizing Uncertainty Among Laypersons and Experts. Andrea Beyer, MPH, PhD EMA PCWP/HCWP meeting September 2015
1 Visualizing Uncertainty Among Laypersons and Experts Andrea Beyer, MPH, PhD EMA PCWP/HCWP meeting September 2015 Contents Background Study objectives Study design Recruitment Results Summary 2 Study
Aspirin for the Prevention of Cardiovascular Disease
Detail-Document #250601 This Detail-Document accompanies the related article published in PHARMACIST S LETTER / PRESCRIBER S LETTER June 2009 ~ Volume 25 ~ Number 250601 Aspirin for the Prevention of Cardiovascular
Heart Attack Readmissions in Virginia
Heart Attack Readmissions in Virginia Schroeder Center Statistical Brief Research by Mitchell Cole, William & Mary Public Policy, MPP Class of 2017 Highlights: In 2014, almost 11.2 percent of patients
Title: Use of Beta-blockers and Mortality Following Ovarian Cancer Diagnosis: A Population-Based Cohort Study
Author's response to reviews Title: Use of Beta-blockers and Mortality Following Ovarian Cancer Diagnosis: A Population-Based Cohort Study Authors: Sigrun A Johannesdottir (saj@dce.au.dk) Morten Schmidt
Psoriasis is associated with increased risk of incident Diabetes Mellitus: A Danish nationwide cohort study
Psoriasis is associated with increased risk of incident Diabetes Mellitus: A Danish nationwide cohort study Khalid U, Hansen PR, Gislason GH, Kristensen SL, Lindhardsen J, Skov L, Torp-Pedersen C, Ahlehoff
Effectiveness of rotavirus vaccination Generic study protocol for retrospective case control studies based on computerised databases
TECHNICAL DOCUMENT Effectiveness of rotavirus vaccination Generic study protocol for retrospective case control studies based on computerised databases www.ecdc.europa.eu ECDC TECHNICAL DOCUMENT Effectiveness
Methodologies for vaccine safety surveillance. Nick Andrews, Statistics Unit Public Health England October 2015
Methodologies for vaccine safety surveillance Nick Andrews, Statistics Unit Public Health England October 2015 Some dramas of the past 20 years which do you think turned out to be real adverse reactions?
The Whitehall II study originally comprised 10,308 (3413 women) individuals who, at
Supplementary notes on Methods The study originally comprised 10,308 (3413 women) individuals who, at recruitment in 1985/8, were London-based government employees (civil servants) aged 35 to 55 years.
Master Class in Preventive Cardiology. The New MI Phenotype OR. Klas Malmberg MD, PhD, FESC Karolinska Institutet, Stockholm Sweden
Master Class in Preventive Cardiology The New MI Phenotype OR Klas Malmberg MD, PhD, FESC Karolinska Institutet, Stockholm Sweden The New MI Phenotype OR Coronary disease and glucose abnormalities Klas
Unwanted sexual attention at work and long-term sickness absence: a follow-up register-based study
Unwanted sexual attention at work and long-term sickness absence: a follow-up register-based study Annie Hogh 1, Paul Maurice Conway 1, Thomas Clausen 2, Ida Elisabeth Huitfeldt Madsen 2 and Hermann Burr
NOAC trials for AF: A review
NOAC trials for AF: A review Chern-En Chiang, MD, PhD, FACC, FESC General Clinical Research Center Division of Cardiology Taipei Veterans General Hospital National Yang-Ming University Taipei, Taiwan Presenter
Attendance rates and outcomes of cardiac rehabilitation in Victoria, 1998
Attendance rates and outcomes of cardiac rehabilitation in Victoria, 1998 CARDIOVASCULAR DISEASE is the leading cause of death in Australia, causing more than 40% of all deaths in 1998. 1 Cardiac rehabilitation
Propensity Score Methods to Adjust for Bias in Observational Data SAS HEALTH USERS GROUP APRIL 6, 2018
Propensity Score Methods to Adjust for Bias in Observational Data SAS HEALTH USERS GROUP APRIL 6, 2018 Institute Institute for Clinical for Clinical Evaluative Evaluative Sciences Sciences Overview 1.
DISCLOSURE STATEMENT
ALCOHOL USE, SUICIDE AND SUICIDAL BEHAVIOR: EVIDENCE FROM STUDIES IN THE EMERGENCY DEPARTMENT AND OTHER SETTINGS Cheryl J. Cherpitel, Dr.P.H. Alcohol Research Group Emeryville, CA The 8th Annual Guze Symposium
10-Year Mortality of Older Acute Myocardial Infarction Patients Treated in U.S. Community Practice
10-Year Mortality of Older Acute Myocardial Infarction Patients Treated in U.S. Community Practice Ajar Kochar, MD on behalf of: Anita Y. Chen, Puza P. Sharma, Neha J. Pagidipati, Gregg C. Fonarow, Patricia
Cardiovascular disease and varenicline (Champix)
Cardiovascular disease and varenicline (Champix) 2013 National Centre for Smoking Cessation and Training (NCSCT). Version 3: August 2013. Authors: Leonie S. Brose, Eleni Vangeli, Robert West and Andy McEwen
WP2 Framework for pharmacoepidemiological studies. WG1 Databases. Study Protocol
WP2 Framework for pharmacoepidemiological studies WG1 Databases Study Protocol Use of Antidepressants and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological
!! Pooled!Analysis!Protocol!and!! Statistical!Analysis!Plan! Pan$European$Multi/Database$Bladder$Cancer$Risk$ Characterisation$Study$$
!! Pooled!Analysis!Protocol!and!! Statistical!Analysis!Plan! Pan$European$Multi/Database$Bladder$Cancer$Risk$ Characterisation$Study$$ Pooled Analysis Based On Individual Patient Level Data$ Study number:
Inventory of paediatric therapeutic needs
15 November 2013 EMA/562919/2013 Human Medicines Development and Evaluation Inventory of paediatric therapeutic needs Neurology Agreed by PDCO October 2013 Adopted by PDCO for release for consultation
Long-term exposure to air pollution and diabetes risk in Danish Nurse Cohort study
Long-term exposure to air pollution and diabetes risk in Danish Nurse Cohort study Anne Busch Hansen a, Line Ravnskjær b, Steffen Loft c, Klaus Kaae Andersen b, Elvira Bräuner d, Rikke Baastrup e, Claire
Risk of Aplastic Anemia in Patients Using Antiepileptic Drugs
Epilepsia, 47(7):1232 1236, 2006 Blackwell Publishing, Inc. C 2006 International League Against Epilepsy Brief Communications Risk of Aplastic Anemia in Patients Using Antiepileptic Drugs Kim B. Handoko,
Effects of Antiepileptic Drug Substitutions on Epileptic Events Requiring Acute Care
Effects of Antiepileptic Drug Substitutions on Epileptic Events Requiring Acute Care Karen L. Rascati, Ph.D., Kristin M. Richards, Ph.D., Michael T. Johnsrud, Ph.D., and Teresa A. Mann, Pharm.D. Study
Lower Risk of Death With SGLT2 Inhibitors in Observational Studies: Real or Bias? Diabetes Care 2018;41:6 10
6 Diabetes Care Volume 41, January 2018 PERSPECTIVES IN CARE Lower Risk of Death With SGLT2 Inhibitors in Observational Studies: Real or Bias? Diabetes Care 2018;41:6 10 https://doi.org/10.2337/dc17-1223
HOMEOPATHY WITHIN THE NATIONAL HEALTH SERVICE, UK
HOMEOPATHY WITHIN THE NATIONAL HEALTH SERVICE, UK Some people take the position that public money should not be spent on homeopathy because there is no proof that it works or tax-payers money shouldn t
THE NATIONAL QUALITY FORUM
THE NATIONAL QUALITY FORUM National Voluntary Consensus Standards for Patient Outcomes Table of Measures Submitted-Phase 1 As of March 5, 2010 Note: This information is for personal and noncommercial use
HOMEOPATHY WITHIN THE NATIONAL HEALTH SERVICE, UK
HOMEOPATHY WITHIN THE NATIONAL HEALTH SERVICE, UK Some people take the position that public money should not be spent on homeopathy because there is no proof that it works or tax-payers money shouldn t
AHA Clinical Science Special Report: November 10, 2015
www.canheart.ca High-density lipoprotein cholesterol and cause-specific mortality: A population-based study of more than 630,000 individuals without prior cardiovascular conditions Dennis T. Ko, MD, MSc;
Cancer and pharmacoepidemiology in Finland. Information sources and research possibilities
Cancer and pharmacoepidemiology in Finland Information sources and research possibilities What I will talk about Register-based data sources available in Finland Register linkage method Available background