International severe asthma registry (ISAR): Protocol for a global registry

J. Mark Fitzgerald; Trung N. Tran; Marianna Alacqua; Alan Altraja; Vibeke Backer; Leif Bjermer; Unnur Bjornsdottir; Arnaud Bourdin; Guy Brusselle; Lakmini Bulathsinhala; John Busby; Giorgio W. Canonica; Victoria Carter; Isha Chaudhry; You Sook Cho; George Christoff; Borja G. Cosio; Richard W. Costello; Neva Eleangovan; Peter G. Gibson; Liam G. Heaney; Enrico Heffler; Mark Hew; Naeimeh Hosseini; Takashi Iwanaga; David J. Jackson; Rupert Jones; Mariko S. Koh; Thao Le; Lauri Lehtimäki; Dora Ludviksdottir; Anke H. Maitland-Van Der Zee; Andrew Menzies-Gow; Ruth B. Murray; Nikolaos G. Papadopoulos; Luis Perez-De-Llano; Matthew Peters; Paul E. Pfeffer; Todor A. Popov; Celeste M. Porsbjerg; Chris A. Price; Chin K. Rhee; Mohsen Sadatsafavi; Yuji Tohda; Eileen Wang; Michael E. Wechsler; James Zangrilli; David B. Price

doi:10.1186/s12874-020-01065-0

International severe asthma registry (ISAR): Protocol for a global registry

J. Mark Fitzgerald, Trung N. Tran, Marianna Alacqua, Alan Altraja, Vibeke Backer, Leif Bjermer, Unnur Bjornsdottir, Arnaud Bourdin, Guy Brusselle, Lakmini Bulathsinhala, John Busby, Giorgio W. Canonica, Victoria Carter, Isha Chaudhry, You Sook Cho, George Christoff, Borja G. Cosio, Richard W. Costello, Neva Eleangovan, Peter G. GibsonLiam G. Heaney, Enrico Heffler, Mark Hew, Naeimeh Hosseini, Takashi Iwanaga, David J. Jackson, Rupert Jones, Mariko S. Koh, Thao Le, Lauri Lehtimäki, Dora Ludviksdottir, Anke H. Maitland-Van Der Zee, Andrew Menzies-Gow, Ruth B. Murray, Nikolaos G. Papadopoulos, Luis Perez-De-Llano, Matthew Peters, Paul E. Pfeffer, Todor A. Popov, Celeste M. Porsbjerg, Chris A. Price, Chin K. Rhee, Mohsen Sadatsafavi, Yuji Tohda, Eileen Wang, Michael E. Wechsler, James Zangrilli, David B. Price

Research output: Contribution to journal › Article › Scientific › peer-review

38 Citations (Scopus)

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Abstract

Background: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi-country registry project initiated to aid in this endeavour. Methods: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (=18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR's collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics and Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders. Conclusions: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally.

Original language	English
Article number	212
Journal	BMC Medical Research Methodology
Volume	20
Issue number	1
DOIs	https://doi.org/10.1186/s12874-020-01065-0
Publication status	Published - 14 Aug 2020
Publication type	A1 Journal article-refereed

Keywords

Disease registry
Protocol
Real-world
Severe asthma

Publication forum classification

Publication forum level 1

ASJC Scopus subject areas

Epidemiology
Health Informatics

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

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s12874-020-01065-0-2Final published version, 3.1 MBLicence: CC BY

http://urn.fi/URN:NBN:fi:tuni-202101171391Licence: CC BY

Cite this

Fitzgerald, J. M., Tran, T. N., Alacqua, M., Altraja, A., Backer, V., Bjermer, L., Bjornsdottir, U., Bourdin, A., Brusselle, G., Bulathsinhala, L., Busby, J., Canonica, G. W., Carter, V., Chaudhry, I., Cho, Y. S., Christoff, G., Cosio, B. G., Costello, R. W., Eleangovan, N., ... Price, D. B. (2020). International severe asthma registry (ISAR): Protocol for a global registry. BMC Medical Research Methodology, 20(1), Article 212. https://doi.org/10.1186/s12874-020-01065-0

@article{d2c4f0d38c25482d9af7d07328d6be7f,

title = "International severe asthma registry (ISAR): Protocol for a global registry",

abstract = "Background: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi-country registry project initiated to aid in this endeavour. Methods: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (=18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR's collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics and Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders. Conclusions: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally.",

keywords = "Disease registry, Protocol, Real-world, Severe asthma",

author = "Fitzgerald, {J. Mark} and Tran, {Trung N.} and Marianna Alacqua and Alan Altraja and Vibeke Backer and Leif Bjermer and Unnur Bjornsdottir and Arnaud Bourdin and Guy Brusselle and Lakmini Bulathsinhala and John Busby and Canonica, {Giorgio W.} and Victoria Carter and Isha Chaudhry and Cho, {You Sook} and George Christoff and Cosio, {Borja G.} and Costello, {Richard W.} and Neva Eleangovan and Gibson, {Peter G.} and Heaney, {Liam G.} and Enrico Heffler and Mark Hew and Naeimeh Hosseini and Takashi Iwanaga and Jackson, {David J.} and Rupert Jones and Koh, {Mariko S.} and Thao Le and Lauri Lehtim{\"a}ki and Dora Ludviksdottir and {Maitland-Van Der Zee}, {Anke H.} and Andrew Menzies-Gow and Murray, {Ruth B.} and Papadopoulos, {Nikolaos G.} and Luis Perez-De-Llano and Matthew Peters and Pfeffer, {Paul E.} and Popov, {Todor A.} and Porsbjerg, {Celeste M.} and Price, {Chris A.} and Rhee, {Chin K.} and Mohsen Sadatsafavi and Yuji Tohda and Eileen Wang and Wechsler, {Michael E.} and James Zangrilli and Price, {David B.}",

note = "Funding Information: ISAR is a global collaborative initiative that allows for prospectively and retrospectively analysing real-life severe asthma data at the patient-level. It is conducted by OPC, with academic and regulatory oversight from the ISC, academic support from REG, ethical governance from ADEPT and joint funding support from OPC and AstraZeneca. ISAR is facilitated by standard data collection via a core set of variables across all participating registries and supporting data collection via electronic data capture, hosting and data entry. Benefitting from the use of aggregate vs. individualised data, ISAR is large enough to provide sufficient statistical power to detect differences and trends. It thus enables collaborating registries to answer key research questions on asthma at a global scale. Funding Information: The International Severe Asthma Registry is conducted by Optimum Patient Care Global Limited, and co-funded by Optimum Patient Care Global Limited and AstraZeneca. ISAR is supported by grants from AstraZeneca and Optimum Patient Care (OPC) Global (a not-for-profit social enterprise). The ISAR steering committee (ISC) was involved in the development of the protocol and is responsible for approving research proposals via a democratic voting process. In addition to 47 clinicians and researchers with an interest and experience in severe asthma, the ISC also includes members of OPC and four medical experts from AstraZeneca. AstraZeneca reviewed the draft before submission; however, decision to submit was made by the authors. Medical writing support was funded by AstraZeneca in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3). Funding Information: AHM-vdZ declares unrestricted grants from GlaxoSmithKline, Novartis and Boehringer Ingelheim, personal fees for advisory board activities from AstraZeneca and a travel grant from Chiesi. AA has received lecture fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MSD, Norameda, Novartis and Orion; sponsorships from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MSD, Norameda and Novartis; and has been a member of advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis and Teva. AM-G declares grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Hoffman La Roche; consultancy agreements with AstraZeneca, Sanofi and Vectura; attendance at advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi and Teva; received speaker fees from AstraZeneca, Boehringer Ingel-heim, Novartis, Teva and Vectura; and attended international conferences for Boehringer Ingelheim and Teva. AB has received speaker fees and grants to his institution from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithK-line and Novartis for unrelated projects. CMP, DL, GC, JB, JMF, MS, RBM, TAP, TL, UB, VB and YSC have no relevant conflicts of interest. CKR declares consultancy and lecture fees from AstraZeneca, Boehringer Ingelheim, GlaxoS-mithKline, MSD, Mundipharma, Novartis, Sandoz, Takeda and Teva-Handok. CAP, IC, LB2, NE, NH and VC are employees of Optimum Patient Care, a co-funder of the International Severe Asthma Registry. DJJ has received advisory board and speaker fees from AstraZeneca, GlaxoSmithKline, Boehringer Ingel-heim, Teva, Napp Pharmaceuticals, Chiesi and Novartis and research grant funding from AstraZeneca. DBP declares board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Mundipharma, Napp Pharmaceuticals, Novartis and Teva; consultancy agreements with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp Pharmaceuticals, Novartis, Pfizer, Teva and Thera-vance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from Aerocrine, AKL Research and Development Ltd., AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Mylan, Mundipharma, Napp Pharmaceuticals, Novartis, Pfizer, Respiratory Effectiveness Group, Teva, Thera-vance, UK National Health Service and Zentiva; payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Pfizer, Skyepharma and Teva; payment for manuscript preparation from Mundi-pharma and Teva; payment for the development of educational materials from Mundipharma and Novartis; payment for travel/accommodation/meeting expenses from Aerocrine, AstraZeneca, Boehringer Ingelheim, Mundi-pharma, Napp Pharmaceuticals, Novartis and Teva; funding for patient enrolment or completion of research from Chiesi, Novartis, Teva and Zentiva; stock/stock options from AKL Research and Development Ltd., which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd. (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd. (Singapore); and is a peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme and Health Technology Assessment. EH has been on advisory boards for Sanofi-Genzyme, GlaxoSmithKline, Novartis, Circassia and Nestl{\`e} Purina. EW has received advisory board fees from AstraZeneca. She has been an investigator on clinical trials sponsored by AstraZeneca, GlaxoSmithKline, Novartis, Teva and National Institute of Allergy and Infectious Diseases (NIAID), for which her institution has received funding. BGC reports personal fees and nonfinancial support from Novartis, grants and personal fees from AstraZeneca, Chiesi and Menarini; personal fees and non-financial support from Teva, grants from Boehringer Ingelheim and personal fees from Sanofi and Mundi-pharma, outside the submitted work. GWC has received research grants as well as lecture or advisory board fees from Menarini, Alk-Abello, Allergy Therapeutics, Anallergo, AstraZeneca, MedImmune, Boehringer Ingelheim, Chiesi Farmaceutici, Circassia, Danone, Faes, Genentech, Guidotti-Malesci, GlaxoS-mithKline, Hal Allergy, Merck, MSD, Mundipharma, Novartis, Orion, Sanofi-Aventis, Sanofi, Genzyme/Regeneron, Stallergenes, UCB Pharma, Uriach Pharma, Teva, Thermo Fisher and Valeas. GB has received honoraria for lectures from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis and Teva. He is a member of advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi/Regeneron and Teva. JZ, MA and TNT are employees of AstraZeneca, a co-funder of the International Severe Asthma Registry. LL declares personal fees for consultancy and lectures from ALK, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mundipharma, Novartis, Orion Pharma, Sanofi and Teva. LB1 has (in the last three years) received lecture or advisory board fees from Alk-Abello, AstraZe-neca, Boehringer, Chiesi, GlaxoSmithKline, Mundipharma, Novartis, Sanofi, Genzyme/Regeneron and Teva. LGH declares he has received grant funding, participated in advisory boards and given lectures at meetings supported by Amgen, AstraZeneca, Boehringer Ingelheim, Circassia, Hoffmann la Roche, GlaxoSmithKline, Novartis and Teva; he has taken part in asthma clinical trials sponsored by Boehringer Ingelheim, Hoffmann la Roche and GlaxoSmithK-line, for which his institution received remuneration; and he is the Academic Lead for the Medical Research Council Stratified Medicine UK Consortium in Severe Asthma, which involves industrial partnerships with a number of pharmaceutical companies, including Amgen, AstraZeneca, Boehringer Ingel-heim, GlaxoSmithKline, Hoffmann la Roche and Janssen. LP declares nonfinancial support, personal fees and grants from Teva; non-financial support and personal fees from Boehringer Ingelheim, Esteve, GlaxoSmithKline, Mun-dipharma and Novartis; personal fees and grants from AstraZeneca and Chiesi; personal fees from Sanofi and non-financial support from Menarini, outside the submitted work. MH declares grants and other advisory board fees (made to his institutional employer) from AstraZeneca, GlaxoSmithKline, Novartis and Seqirus for unrelated projects. MP declares personal fees and non-financial support from AstraZeneca and GlaxoSmithKline. MEW reports receiving consulting honoraria from AstraZeneca, Boehringer Ingelheim, Gen-entech, GlaxoSmithKline, Novartis, Regeneron, Sanofi and Teva. MSK has been a member of advisory boards for AstraZeneca, GlaxoSmithKline and Sanofi and has received honoraria from AstraZeneca, GlaxoSmithKline and Sanofi. NP declares speaker fees and grants to his institution from AstraZeneca, Glax-oSmithKline and Novartis for unrelated projects. PEP declares speaker fees and grants to his institution from AstraZeneca, GlaxoSmithKline and Novartis for unrelated projects. PG declares speaker fees and grants to his institution from AstraZeneca, GlaxoSmithKline and Novartis for unrelated projects. RWC has received honoraria for lectures from Aerogen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis and Teva. He is a member of advisory boards for GlaxoSmithKline and Novartis, has received grant support from GlaxoSmithKline and Aerogen and has patents in the use of acoustics in the diagnosis of lung disease, assessment of adherence and prediction of exacerbations. RJ declares grants from Novartis, GlaxoSmithKline and AstraZeneca; personal fees for consultancy and speaker fees or travel support from GlaxoS-mithKline, AstraZeneca, Boehringer Ingelheim, Chiesi, Nutricia, OPRI and Pfizer. TI declares grants from Astellas, Boehringer Ingelheim, Daiichi-Sankyo, Kyorin, Meiji Seika Pharma and Teijin Pharma and lecture fees from Kyorin. YT declares honoraria from Kyorin Pharma and Teijin Pharma and research funding from Kyorin and Meiji Seika Pharma. Publisher Copyright: {\textcopyright} 2020 The Author(s). Copyright: Copyright 2020 Elsevier B.V., All rights reserved.",

year = "2020",

month = aug,

day = "14",

doi = "10.1186/s12874-020-01065-0",

language = "English",

volume = "20",

number = "1",

}

Fitzgerald, JM, Tran, TN, Alacqua, M, Altraja, A, Backer, V, Bjermer, L, Bjornsdottir, U, Bourdin, A, Brusselle, G, Bulathsinhala, L, Busby, J, Canonica, GW, Carter, V, Chaudhry, I, Cho, YS, Christoff, G, Cosio, BG, Costello, RW, Eleangovan, N, Gibson, PG, Heaney, LG, Heffler, E, Hew, M, Hosseini, N, Iwanaga, T, Jackson, DJ, Jones, R, Koh, MS, Le, T, Lehtimäki, L, Ludviksdottir, D, Maitland-Van Der Zee, AH, Menzies-Gow, A, Murray, RB, Papadopoulos, NG, Perez-De-Llano, L, Peters, M, Pfeffer, PE, Popov, TA, Porsbjerg, CM, Price, CA, Rhee, CK, Sadatsafavi, M, Tohda, Y, Wang, E, Wechsler, ME, Zangrilli, J & Price, DB 2020, 'International severe asthma registry (ISAR): Protocol for a global registry', BMC Medical Research Methodology, vol. 20, no. 1, 212. https://doi.org/10.1186/s12874-020-01065-0

TY - JOUR

T1 - International severe asthma registry (ISAR)

T2 - Protocol for a global registry

AU - Fitzgerald, J. Mark

AU - Tran, Trung N.

AU - Alacqua, Marianna

AU - Altraja, Alan

AU - Backer, Vibeke

AU - Bjermer, Leif

AU - Bjornsdottir, Unnur

AU - Bourdin, Arnaud

AU - Brusselle, Guy

AU - Bulathsinhala, Lakmini

AU - Busby, John

AU - Canonica, Giorgio W.

AU - Carter, Victoria

AU - Chaudhry, Isha

AU - Cho, You Sook

AU - Christoff, George

AU - Cosio, Borja G.

AU - Costello, Richard W.

AU - Eleangovan, Neva

AU - Gibson, Peter G.

AU - Heaney, Liam G.

AU - Heffler, Enrico

AU - Hew, Mark

AU - Hosseini, Naeimeh

AU - Iwanaga, Takashi

AU - Jackson, David J.

AU - Jones, Rupert

AU - Koh, Mariko S.

AU - Le, Thao

AU - Lehtimäki, Lauri

AU - Ludviksdottir, Dora

AU - Maitland-Van Der Zee, Anke H.

AU - Menzies-Gow, Andrew

AU - Murray, Ruth B.

AU - Papadopoulos, Nikolaos G.

AU - Perez-De-Llano, Luis

AU - Peters, Matthew

AU - Pfeffer, Paul E.

AU - Popov, Todor A.

AU - Porsbjerg, Celeste M.

AU - Price, Chris A.

AU - Rhee, Chin K.

AU - Sadatsafavi, Mohsen

AU - Tohda, Yuji

AU - Wang, Eileen

AU - Wechsler, Michael E.

AU - Zangrilli, James

AU - Price, David B.

N1 - Funding Information: ISAR is a global collaborative initiative that allows for prospectively and retrospectively analysing real-life severe asthma data at the patient-level. It is conducted by OPC, with academic and regulatory oversight from the ISC, academic support from REG, ethical governance from ADEPT and joint funding support from OPC and AstraZeneca. ISAR is facilitated by standard data collection via a core set of variables across all participating registries and supporting data collection via electronic data capture, hosting and data entry. Benefitting from the use of aggregate vs. individualised data, ISAR is large enough to provide sufficient statistical power to detect differences and trends. It thus enables collaborating registries to answer key research questions on asthma at a global scale. Funding Information: The International Severe Asthma Registry is conducted by Optimum Patient Care Global Limited, and co-funded by Optimum Patient Care Global Limited and AstraZeneca. ISAR is supported by grants from AstraZeneca and Optimum Patient Care (OPC) Global (a not-for-profit social enterprise). The ISAR steering committee (ISC) was involved in the development of the protocol and is responsible for approving research proposals via a democratic voting process. In addition to 47 clinicians and researchers with an interest and experience in severe asthma, the ISC also includes members of OPC and four medical experts from AstraZeneca. AstraZeneca reviewed the draft before submission; however, decision to submit was made by the authors. Medical writing support was funded by AstraZeneca in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3). Funding Information: AHM-vdZ declares unrestricted grants from GlaxoSmithKline, Novartis and Boehringer Ingelheim, personal fees for advisory board activities from AstraZeneca and a travel grant from Chiesi. AA has received lecture fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MSD, Norameda, Novartis and Orion; sponsorships from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MSD, Norameda and Novartis; and has been a member of advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis and Teva. AM-G declares grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Hoffman La Roche; consultancy agreements with AstraZeneca, Sanofi and Vectura; attendance at advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi and Teva; received speaker fees from AstraZeneca, Boehringer Ingel-heim, Novartis, Teva and Vectura; and attended international conferences for Boehringer Ingelheim and Teva. AB has received speaker fees and grants to his institution from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithK-line and Novartis for unrelated projects. CMP, DL, GC, JB, JMF, MS, RBM, TAP, TL, UB, VB and YSC have no relevant conflicts of interest. CKR declares consultancy and lecture fees from AstraZeneca, Boehringer Ingelheim, GlaxoS-mithKline, MSD, Mundipharma, Novartis, Sandoz, Takeda and Teva-Handok. CAP, IC, LB2, NE, NH and VC are employees of Optimum Patient Care, a co-funder of the International Severe Asthma Registry. DJJ has received advisory board and speaker fees from AstraZeneca, GlaxoSmithKline, Boehringer Ingel-heim, Teva, Napp Pharmaceuticals, Chiesi and Novartis and research grant funding from AstraZeneca. DBP declares board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Mundipharma, Napp Pharmaceuticals, Novartis and Teva; consultancy agreements with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Napp Pharmaceuticals, Novartis, Pfizer, Teva and Thera-vance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from Aerocrine, AKL Research and Development Ltd., AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Mylan, Mundipharma, Napp Pharmaceuticals, Novartis, Pfizer, Respiratory Effectiveness Group, Teva, Thera-vance, UK National Health Service and Zentiva; payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Mundipharma, Novartis, Pfizer, Skyepharma and Teva; payment for manuscript preparation from Mundi-pharma and Teva; payment for the development of educational materials from Mundipharma and Novartis; payment for travel/accommodation/meeting expenses from Aerocrine, AstraZeneca, Boehringer Ingelheim, Mundi-pharma, Napp Pharmaceuticals, Novartis and Teva; funding for patient enrolment or completion of research from Chiesi, Novartis, Teva and Zentiva; stock/stock options from AKL Research and Development Ltd., which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd. (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd. (Singapore); and is a peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme and Health Technology Assessment. EH has been on advisory boards for Sanofi-Genzyme, GlaxoSmithKline, Novartis, Circassia and Nestlè Purina. EW has received advisory board fees from AstraZeneca. She has been an investigator on clinical trials sponsored by AstraZeneca, GlaxoSmithKline, Novartis, Teva and National Institute of Allergy and Infectious Diseases (NIAID), for which her institution has received funding. BGC reports personal fees and nonfinancial support from Novartis, grants and personal fees from AstraZeneca, Chiesi and Menarini; personal fees and non-financial support from Teva, grants from Boehringer Ingelheim and personal fees from Sanofi and Mundi-pharma, outside the submitted work. GWC has received research grants as well as lecture or advisory board fees from Menarini, Alk-Abello, Allergy Therapeutics, Anallergo, AstraZeneca, MedImmune, Boehringer Ingelheim, Chiesi Farmaceutici, Circassia, Danone, Faes, Genentech, Guidotti-Malesci, GlaxoS-mithKline, Hal Allergy, Merck, MSD, Mundipharma, Novartis, Orion, Sanofi-Aventis, Sanofi, Genzyme/Regeneron, Stallergenes, UCB Pharma, Uriach Pharma, Teva, Thermo Fisher and Valeas. GB has received honoraria for lectures from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis and Teva. He is a member of advisory boards for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Sanofi/Regeneron and Teva. JZ, MA and TNT are employees of AstraZeneca, a co-funder of the International Severe Asthma Registry. LL declares personal fees for consultancy and lectures from ALK, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mundipharma, Novartis, Orion Pharma, Sanofi and Teva. LB1 has (in the last three years) received lecture or advisory board fees from Alk-Abello, AstraZe-neca, Boehringer, Chiesi, GlaxoSmithKline, Mundipharma, Novartis, Sanofi, Genzyme/Regeneron and Teva. LGH declares he has received grant funding, participated in advisory boards and given lectures at meetings supported by Amgen, AstraZeneca, Boehringer Ingelheim, Circassia, Hoffmann la Roche, GlaxoSmithKline, Novartis and Teva; he has taken part in asthma clinical trials sponsored by Boehringer Ingelheim, Hoffmann la Roche and GlaxoSmithK-line, for which his institution received remuneration; and he is the Academic Lead for the Medical Research Council Stratified Medicine UK Consortium in Severe Asthma, which involves industrial partnerships with a number of pharmaceutical companies, including Amgen, AstraZeneca, Boehringer Ingel-heim, GlaxoSmithKline, Hoffmann la Roche and Janssen. LP declares nonfinancial support, personal fees and grants from Teva; non-financial support and personal fees from Boehringer Ingelheim, Esteve, GlaxoSmithKline, Mun-dipharma and Novartis; personal fees and grants from AstraZeneca and Chiesi; personal fees from Sanofi and non-financial support from Menarini, outside the submitted work. MH declares grants and other advisory board fees (made to his institutional employer) from AstraZeneca, GlaxoSmithKline, Novartis and Seqirus for unrelated projects. MP declares personal fees and non-financial support from AstraZeneca and GlaxoSmithKline. MEW reports receiving consulting honoraria from AstraZeneca, Boehringer Ingelheim, Gen-entech, GlaxoSmithKline, Novartis, Regeneron, Sanofi and Teva. MSK has been a member of advisory boards for AstraZeneca, GlaxoSmithKline and Sanofi and has received honoraria from AstraZeneca, GlaxoSmithKline and Sanofi. NP declares speaker fees and grants to his institution from AstraZeneca, Glax-oSmithKline and Novartis for unrelated projects. PEP declares speaker fees and grants to his institution from AstraZeneca, GlaxoSmithKline and Novartis for unrelated projects. PG declares speaker fees and grants to his institution from AstraZeneca, GlaxoSmithKline and Novartis for unrelated projects. RWC has received honoraria for lectures from Aerogen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis and Teva. He is a member of advisory boards for GlaxoSmithKline and Novartis, has received grant support from GlaxoSmithKline and Aerogen and has patents in the use of acoustics in the diagnosis of lung disease, assessment of adherence and prediction of exacerbations. RJ declares grants from Novartis, GlaxoSmithKline and AstraZeneca; personal fees for consultancy and speaker fees or travel support from GlaxoS-mithKline, AstraZeneca, Boehringer Ingelheim, Chiesi, Nutricia, OPRI and Pfizer. TI declares grants from Astellas, Boehringer Ingelheim, Daiichi-Sankyo, Kyorin, Meiji Seika Pharma and Teijin Pharma and lecture fees from Kyorin. YT declares honoraria from Kyorin Pharma and Teijin Pharma and research funding from Kyorin and Meiji Seika Pharma. Publisher Copyright: © 2020 The Author(s). Copyright: Copyright 2020 Elsevier B.V., All rights reserved.

PY - 2020/8/14

Y1 - 2020/8/14

N2 - Background: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi-country registry project initiated to aid in this endeavour. Methods: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (=18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR's collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics and Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders. Conclusions: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally.

AB - Background: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi-country registry project initiated to aid in this endeavour. Methods: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (=18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR's collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics and Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders. Conclusions: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally.

KW - Disease registry

KW - Protocol

KW - Real-world

KW - Severe asthma

U2 - 10.1186/s12874-020-01065-0

DO - 10.1186/s12874-020-01065-0

M3 - Article

C2 - 32819285

AN - SCOPUS:85089769760

SN - 1471-2288

VL - 20

JO - BMC Medical Research Methodology

JF - BMC Medical Research Methodology

IS - 1

M1 - 212

ER -

International severe asthma registry (ISAR): Protocol for a global registry

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