GARFIELD- AF Ambassadors Meeting London 21 st October 2016 The - - PowerPoint PPT Presentation
GARFIELD- AF Ambassadors Meeting London 21 st October 2016 The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer Pharma AG www.tri-london.ac.uk GARFIELD-AF Steering Committee Meeting Court Room, Barber- Surgeons
www.tri-london.ac.uk The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer Pharma AG
www.tri-london.ac.uk The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer Pharma AG
Court Room, Barber-Surgeon’s Hall London 21st October 2016
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Title 10:00 Overview of publications and communications plan and processes Gloria Kayani 10:20 Overview of research questions for upcoming papers Professor John Camm 11:00 Discussion: 2017 communications and publications plan Prioritization of papers for 2017 ESC 2017 Core communication message strategy for 2017 All 11:40 High-level communication plans for 2018–2020 All 12:00 Meeting end
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Objectives for today’s meeting
www.tri-london.ac.uk The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer Pharma AG
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Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
ESC
Barcelona, 26-30/08/17
ACC
Washington, 17–19/03/17
GARFIELD Symposium
Ambassadors Meeting
(tbc)
Deadline ESC abstracts ESC abstract results ESC LBS abstract results Deadline ASH abstracts Deadline ACC abstracts
ISPOR Annual Intl Meeting
Boston, 20–24/05/17
AHA
Anaheim, 11–15/11/17
ASH
Deadline ASH symposium programme Deadline ESC LBS abstracts
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Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
ESC
Barcelona, 26-30 Aug
ACC
Washington, 17–19 Mar
GARFIELD Symposium
Ambassadors Meeting
(tbc)
Deadline ESC abstracts
ESC LBS abstract results Deadline ASH abstracts Deadline ACC abstracts
ISPOR Annual Intl Meeting
Boston, 20–24/05/17
AHA
Anaheim, 11–15/11/17
ASH
Deadline ASH symposium programme
Deadline ESC LBS abstracts
2016 2017 J A S O N D J F M A M J
Descriptive manuscripts Treatment patterns Risk scores Audit paper Retrospective vs prospective pts NOAC vs VKA* Patients receiving AP* AF registries review Outcome manuscripts Quality of VKA control INR in Asia vs other regions Gender outcomes Treatment of low-risk patients* Elderly patients CKD ACS patients Early mortality* Optimal INR (time dependent analysis): regional comparison
Submission and publication timelines are provisional and subject to change *Based on ESC symposium presentations
GARFIELD-AF publication overview
Eur Heart J - QCCO Eur Heart J Heart PLOS ONE Int J Cardiol BMJ open access Priority to be confirmed Anticipated submission Submitted Anticipated publication Accepted/published
2016 2017 J A S O N D J F M A M J
Regional / National
2–3 per quarter
Poland The Netherlands Regional : LATAM France Japan Regional : Asia UK
Submission and publication timelines are provisional and subject to change Clin Cardiol Neth Heart J Kardiol Pol Anticipated submission Submitted Anticipated publication Accepted BMJ
GARFIELD-AF publication overview
2016 2017 J A S O N D J F M A M J
GARFIELD-AF scores (validation) Baseline patient characteristics Geographic variations in event rates Comparative effectiveness Interim analyses (Aetion collaboration) Complete analyses Statistical methodology Causal /Dynamic models INR data (when, in whom, how much needed?) Prediction models
Submission and publication timelines are provisional and subject to change Anticipated submission Submitted Anticipated publication Accepted Initiation
GARFIELD-ORBIT collaboration
Priority to be confirmed Priority to be confirmed Priority to be confirmed
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Working title Lead Co-authors Target journal/Congress GARFIELD-AF score: Identifying patients with AF and "low" thromboembolic risk who are poorly characterized by CHA2DS2-VASc Fox Fox, Lucas, Pieper, Bassand,Camm, Fitzmaurice, Goldhaber, Goto, Haas, Hacke, Kayani, Oto, Mantovani, Misselwitz, Piccini, Turpie, Verheugt, Kakkar Eur Heart J (responding to reviewers’ comments) Stats methodology: Prediction models Thomas Pieper, Accetta, Gao TBC Geographical variations in event rates (stroke, major bleeds, mortality) Fox Accetta , Darius , Goto , Kayani , Koretsune , Oh, Parkhomenko, Sawhney , Stepinska , Piccini, Kakkar TBC Global Trends in Use of Oral Anticoagulation for Patients with Atrial Fibrillation: Results across the GARFIELD-AF and ORBIT-AF Programs Steinberg Camm, Fox, Gao, Goldhaber, Haas, Kakkar, Kayani, Piccini, Thomas, Turpie, Verheugt ACC abstract Stats methodology: INR data (when, in whom, how much needed?) Thomas Pieper, Accetta TBC Comparative effectiveness: Causal /Dynamic models Thomas Pieper, Accetta, Gao TBC Comparative effectiveness: Interim analyses Camm, Piccini, Kakkar Gao
ESC Late-breaking abstract? Comparative effectiveness: Final analyses
Camm, Piccini, Kakkar GARFIELD-AF steering committee
TBC
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Title Lead Co-authors The prescribing of antiplatelet therapy only in patients with nonvalvular atrial fibrillation: Results from the GARFIELD-AF registry Verheugt Al Mahmeed, Ambrosio, Angchaisuksiri, Atar, Bassand, Camm, Cools, Eikelboom, Gao, Kayani, Lim, Misselwitz, van Eickels, Kakkar Treatment and outcomes of patients with nonvalvular atrial fibrillation according to guideline-defined anticoagulation thresholds: Results from the GARFIELD-AF registry Camm Bassand, Goldhaber, Turpie, Misselwitz, Oh, Van Eickels, Agnelli, Raatikainen Factors determining global trends in the prescribing of vitamin k antagonists (VKA) and non-VKA oral anticoagulants (NOACs): Results from the GARFIELD-AF registry Camm, Haas Ambrosio, Kayani, Koretsune, Le Heuzey, Misselwitz, Parkhomenko, Pieper, Stępińska, van Eickels, Kakkar Early mortality in newly diagnosed nonvalvular AF Goldhaber Camm, Accetta, Bassand, Fitzmaurice, Goto, Haas, Hacke, Kayani, Misselwitz, Turpie, van Eickels, Verheugt, Kakkar Global Trends in Use of Oral Anticoagulation for Patients with Atrial Fibrillation: Results across the GARFIELD-AF and ORBIT-AF Programs Steinberg Gao, Shrader, Pieper, Thomas, Camm, Ezekowitz, Fonarow, Gersh, Goldhaber, Haas, Hacke, Kowey, Nacarrelli, Reiffel, Turpie, Verheugt, Piccini, Kakkar, Petersen, Fox
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GARFIELD-AF: branching out
Communications focus for ESC 2016
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e.g. Theme: Holistic approach/ integrated care
www.tri-london.ac.uk The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer Pharma AG
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Publications Committee
Members
(TRI) A John Camm, London, UK (Chair) Samuel Z Goldhaber, Boston, MA, USA
Sylvia Haas, Munich, Germany Gloria Kayani, London, UK
(TRI) who participate as needed Jean-Pierre Bassand, Besançon, France Keith AA Fox, Edinburgh, UK
Lorenzo G Mantovani, Naples, Italy Karen Pieper, Durham, USA
Coordinators and TRI Statisticians
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TRI Publications Support Group
TRI, who assist in daily administrative tasks and, when needed
and Haiyan Gao) and Garfield-AF Medical Writers (Rae Hobbs and Emily Chu)
consolidate, and facilitate publication and presentation opportunities on a national and global level
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Role of the Publications Committee
Develop, in collaboration with the TRI, the GARFIELD-AF Publication Guidelines Define, coordinate, and author the GARFIELD-AF Publication Plan Review, prioritize or reject (if unfeasible or duplicating another project), all GARFIELD-AF publication proposals and manuscripts Liaise with the TRI to facilitate the generation of publications and presentations
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TRI PUBLICATIONS COMMITTEE Proposal to SC member for review & submission Proposal to NCC member for review & submission Global analyses National analyses UNRESTRICTED GLOBAL USE
http://www.garfield registry.org/
SUBMIT SUBMIT APPROVE
GARFIELD-AF Website Global analyses
SUBMIT AUTO
National analyses
SUBMIT
For GARFIELD- AF investigators For third parties
ANALYSIS & AUTHORSHIP Lead by GARFIELD-AF investigator
PUBLICATION/ PRESENTATION APPROVE APPROVE
http://www.garfield registry.org
www.tri-london.ac.uk Keyword primary (GARFIELD TREE) Keyword secondary Working title Lead author Congress/ Journal Cohort scope Status
Treatment practices Protocol International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD) Kakkar Am Heart J 6 Published
2012
Treatment practices Global Risk Profiles and Antithrombotic Treatment of Patients Newly Diagnosed with Atrial Fibrillation at Risk of Stroke: Perspectives from the International, Observational, Prospective GARFIELD Registry Kakkar PLOS ONE 6 Published
2013
Methodology National Protocol An international longitudinal registry of patients with atrial fibrillation at risk of stroke (GARFIELD): the UK protocol. Apenteng BMC Cardiovasc Dis 6 Published
2013
Treatment practices National Chinese subgroup analysis of the global anticoagulant registry in the FIELD (GARFIELD) registry in the patients with non-valvular atrial fibrillation Sun Zhonghua Xin Xue Guan Bing Za Zhi 6 Published
2014
Clinical outcomes Gender Does sex affect anticoagulant use for stroke prevention in non-valvular atrial fibrillation? The prospective Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) Lip Circ Cardiovasc Qual Outcomes C1 + C2 6 Published
2015
Treatment practices National GARFIELD-AF - First data on healthcare of patients with atrial fibrillation in Germany Haas Dtsch Med Wochenschr 6 Published
2015
Treatment practices National Stroke prevention in AF patients in Poland and
GARFIELD-AF registry Stępińska Kardiol Pol 6 Published
2016
Treatment practices National The Global Anticoagulant Registry in the FIELD- Atrial Fibrillation (GARFIELD-AF) : Exploring the changes in anticoagulant practice in patients with non-valvular atrial fibrillation in the Netherlands Ten Cate Neth Heart J
2016
Treatment practices INR Comparison of international normalized ratio audit parameters in patients enrolled in GARFIELD-AF and treated with vitamin K antagonists Fitzmaurice Br J Haem C1+C2 6 Published
2016
Treatment practices INR Vitamin K antagonist control in patients with atrial fibrillation in Asia compared with other regions of the world: Real-world data from the GARFIELD-AF registry Oh Int J Cardiol C1+C2 6 Published
2016
Treatment practice Treatment patterns Evolving antithrombotic treatment patterns for patients with newly diagnosed atrial fibrillation Camm Heart C1–C4 6 Published
2016
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Clinical outcomes 2-year Two-year outcomes of patients with newly diagnosed atrial fibrillation: results from GARFIELD-AF Bassand Eur Heart J C1+C2 6 Published
2016
Clinical outcomes INR Quality of Vitamin K Antagonist Control and 1- Year Outcomes in Patients with Atrial Fibrillation: A Global Perspective from the GARFIELD-AF Registry Haas Plos One C1-C3 6 Published
2016
Methodology Audit Evolving quality standards for large-scale registries – The GARFIELD-AF experience Fox Eur Heart J - QCCO C1–C3 5 Responding to Journal reviewers
2016
Risk stratification GARFIELD score (primary paper) Identifying patients with atrial fibrillation and "low" thromboembolic risk who are poorly characterized by CHA2DS2-VASc Fox Eur Heart J C1-C3 4 Submitted
2016
Clinical outcomes Gender Impact of gender on event rates at 1 year in patients with newly diagnosed non-valvular atrial fibrillation: contemporary perspective from the GARFIELD-AF registry Camm BMJ Open Access C1–C3 4 Submitted
2016
Geographic differences LATAM Stroke prevention in patients from Latin America with non-valvular atrial fibrillation: Insights from the GARFIELD-AF registry Sánchez Clin Cardiol C1–C3, 1 yr fu 3 Draft (Final) Clinical outcomes Elderly Two-year clinical outcomes and management of elderly patients with newly diagnosed atrial fibrillation: results from GARFIELD-AF Goldhaber Am J Med C1–C2, 2 yr fu 2 Draft Geographic differences National National manuscript for France LeHeuzey Rev Med Liege French C1-4; n=1387 1.1 Draft Methodology Retrospective Analysis of retrospective validation cohort vs prospective patients in C1 – with 2 yr outcomes Fox C1 1.1 Draft Burden of disease Baseline GARFIELD-AF and ORBIT-AF - Baseline characteristics Camm, Piccini, Thomas C1-C4 0/1 Draft Geographic differences / Clinical
GARFIELD-AF and ORBIT-AF - Geographical variations in event rates (stroke, major bleeds, mortality) Fox C1-C3 0/1 Draft Treatment practices Antiplatelet therapy Antiplatelet therapy - Baseline characteristics of patients [including economic status] Verheugt C1–C2 and C3–C4 0/1 Draft
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AC and/or AP therapy Mantovani Treatment practices Kidney function Impact of weight/kidney function on NOAC dosing - are patients being under-treated? 0 Planning Burden of disease / Geographic differences Comorbities Does the impact of individual and combined comorbid conditions differ in Asian and Caucasian populations? [Global burden: are we correct in attributing the same burden of risk of different comorbidities in different populations?] Kakkar 0 Planning Clinical outcomes Comparative effectiveness Outcomes 30d after initiation with VKA and NOACs 0 Planning Clinical outcomes Comparative effectiveness Rhythm control vs. rate control among patients with atrial fibrillation: outcomes according to anticoagulant treatment patterns [Proposal no. 2012_11; GAR13_17; GAR13_15; GAR13_15] Atar 0 Planning Clinical outcomes Comparative effectiveness Outcomes associated with HAS-BLED in treated and untreated patients Fitzmaurice 0 Planning Clinical outcomes Comparative effectiveness The outcomes associated with CHADS2 vs CHA2DS2-VASc in treated and untreated patients Fitzmaurice 0 Planning Clinical outcomes Hypertension Outcomes in patients with and without hypertension and controlled versus uncontrolled hypertension AND impact of concomitant medication (incl. ACE-inhibitors, ARBs, statins, NSAIDs) on outcomes [ GAR13_12] Bassand Camm 1 and 2 0 Planning Clinical outcomes Obesity Obesity: Baseline characteristics, treatment and
Goldhaber 0 Planning Clinical outcomes Prior stroke Two-year outcomes in atrial fibrillation patients with versus without a previous stroke or transient ischaemic attack: findings from the international prospective GARFIELD Registry Kakkar/ Hacke 0 Planning Clinical outcomes Bleeding Effect of serious bleeding events on outcomes in patients with non-valvular atrial fibrillation on vitamin K antagonist therapy. The prospective international GARFIELD Registry Goto 1 and 2 0 Planning Methodology Statistics GARFIELD-AF and ORBIT-AF - stats methodology
Thomas, Pieper, Accetta 0 Planning Risk strafication Bleeding Relationship between stroke and bleeding risk scores and intracranial haemorrhage in AF; perform sensitivity analysis with HAS-BLED Steering Committee 0 Planning
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Abstract and manuscript development guidelines
Approval by the Publications Committee
the registry data, whether they pertain to a single, several, or all participating centres, require approval, in advance, from the PC
Congress submissions
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Manuscript writing deadline & High-priority papers
Once a publication has been presented at a major scientific meeting and the author received PC approval to develop it into a manuscript, the lead author has 3 months in which to write the manuscript and circulate it to the PC for review (assuming all relevant data are available) High-priority papers The PC will review the list of all ongoing manuscripts at least twice each year (with additional scheduled teleconferences), with special attention to high-priority classification. Criteria for classifying a paper as high priority include: 1) scientific importance of potential findings 2) potential impact of publication on the future of the GARFIELD-AF Registry 3) potential for high visibility in wide circulation scientific journals 4) urgency in making findings available to scientific community and/or public
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Nominees for lead authorship of GARFIELD-AF publications (based on global data) will be the Steering Committee and NCIs Paper limit for first authors Investigators are limited to first authorship on no more than two papers in progress
www.tri-london.ac.uk The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer Pharma AG
www.tri-london.ac.uk Working title Lead Co-authors Target journal Characterizing at-risk patients (CHA2DS2VASc ≥ 2) who are under anticoagulated Camm TBC Characterizing patients with a low risk of stroke (CHA2DS2VASc ≥ 0 or 1) who appear to be ‘over’ anticoagulated Camm TBC Heart failure: Baseline characteristics, treatment and
Ambrosio, Corbalan Pereira-Barretto, Al Mahmeed, Le Heuzey, Jerjes-Sánchez, Stepinska, Parkhomenko, Steffel, Panchenko TBC Global disease burden / Direct healthcare costs associated with AF Mantovani Expressed an interest: Ambrosio TBC Baseline comorbidities (scope to be determined) TBC Bassand, Corbalan, Gersh, Goto, Misselwitz, van Eickels, Verheugt National coordinators who expressed an interest: Parkhomenko, Stepinska TBC Regional manuscript(s): Asia (scope to be determined) TBC TBC
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Dementia: Baseline characteristics, treatment and outcomes Type of atrial fibrillation (including symptomatic status of AF): Patient characteristics, prognosis, and
Stratification of obesity and metabolic syndrome: Baseline characteristics, treatment and outcomes Outcomes in patients with vs without a prior stroke/TIA Outcomes in patients with and without hypertension, in patients with controlled and uncontrolled hypertension, AND according to class of antihypertensive
*Priority topics in red identified by at least 2 members of SC
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Registry
*Priority topics in red identified by at least 2 members of SC
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THERAPY PERSISTENCE
regional differences/similarities and a change of pattern over time) RISK STRATIFICATION
Caucasian populations? [Global burden: are we correct in attributing the same burden of risk for different comorbidities in different populations?] GEOGRAPHIC VARIATION
Western European patients?
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1. Characterizing at-risk patients (CHA2DS2VASc ≥ 2) who are under anticoagulated 2. Characterizing patients with a low risk of stroke (CHA2DS2VASc ≥ 0 or 1) who appear to be ‘over’ anticoagulated 3. Heart failure: Baseline characteristics, treatment and outcomes 4. Global disease burden / Direct healthcare costs associated with AF 5. Baseline comorbidities 6. Regional manuscript(s): Asia 7. Effect of major bleeding events on outcomes (VKA vs NOAC) 8. NOAC dosing: Impact of weight/kidney function on NOAC dosing - are patients being under-treated? 9. Early comparative effectiveness: Outcomes 30 days after initiation with VKA and NOACs 10. Dementia: Baseline characteristics, treatment and outcomes 11. Type of atrial fibrillation (including symptomatic status of AF): Patient characteristics, prognosis, and
12. Stratification of obesity and metabolic syndrome: Baseline characteristics, treatment and outcomes 13. Outcomes in patients with and without a prior stroke/TIA 14. Outcomes in patients with and without hypertension, in patients with controlled and uncontrolled hypertension, AND according to class of antihypertensive
www.tri-london.ac.uk The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer Pharma AG
Research questions to be answered Answers and/or new information (hypotheses): Which cohort(s) and which follow-up time: Which population (treatment, ethnicity, co-morbidities etc..) Limitations
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Title Lead Co-authors
www.tri-london.ac.uk The GARFIELD-AF registry is funded by an unrestricted research grant from Bayer Pharma AG