Development of the International Severe Asthma Registry (ISAR): A Modified Delphi Study

Bulathsinhala, Lakmini; Eleangovan, Neva; Heaney, Liam G.; Menzies‐Gow, Andrew; Gibson, Peter G.; Peters, Matthew J.; Hew, Mark; Boven, Job F M van; Lehtimäki, Lauri; Ganse, Éric Van; Belhassen, Manon; Harvey, Erin S.; Llano, Luís Pérez de; Zee, Anke‐Hilse Maitland‐van der; Papadopoulos, Nikolaos G.; FitzGerald, J. Mark; Porsbjerg, Celeste; Canonica, Giorgio Walter; Backer, Vibeke; Rhee, Chin Kook; Verhamme, Katia; Buhl, Roland; Cosío, Borja G.; Carter, Victoria; Price, Chris; Le, Thao; d’Alcontres, Martina Stagno; Gopalan, Gokul; Tran, Trung; Price, David

doi:10.1016/j.jaip.2018.08.016

Cited by 45 publications

(54 citation statements)

References 27 publications

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“…Variables included in DSAR are coordinated with the variables collected in the two existing international severe asthma databases, which are currently being set up: The International Severe Asthma Register (ISAR) [16] and the pan-European database under ERS, the Severe Heterogenous Asthma Research Collaboration, Patient-centered (SHARP) ERS Clinical Research Collaboration [17]. This will provide opportunities for comparing data, but also for integrating data for international research projects and publications.…”

Section: Variables Collectedmentioning

confidence: 99%

The Danish severe asthma register: an electronic platform for severe asthma management and research

Hansen

Hilberg

Ulrik

et al. 2020

European Clinical Respiratory Journal

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The evaluation and management of severe asthma patients require collection of comprehensive information, which is often a challenge in a busy outpatient clinic. The Danish Severe Asthma Register (DSAR) was designed as an electronic patient record form that captures operational clinical data and provides a clinical overview of the severe asthma patient. DSAR is a nationwide register; all patients in Denmark who are treated with biologics for severe asthma are included, and data are as a minimum entered at start of biological treatment, after four and 12 months of treatment, and hereafter annually. Currently, there are data from 621 treatment courses with biologics included in DSAR, with 71% of patients treated with anti-IL-5 drugs and 29% with an anti-IgE drug. Patients enter Patient Reported Outcome Measures electronically on tablets when they arrive in the outpatient clinic and their answers are immediately available to the clinician during the consultation. Nurses and doctors enter clinical data into DSAR during the consultation. DSAR offers immediate access to well-presented longitudinal overview and automatically creates a journal output that can be copy-pasted into the hospital's existing health record form. DSAR is also currently expanding with an app, to be used for monitoring of home-treatment. In addition to serving as an electronic patient record form, DSAR will also provide opportunities to monitor the real-life efficacy of biological treatment for severe asthma in Denmark, and it will be a valuable research platform that will aid in answering important research questions on severe asthma in the future.

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Section: Variables Collectedmentioning

confidence: 99%

The Danish severe asthma register: an electronic platform for severe asthma management and research

Hansen

Hilberg

Ulrik

et al. 2020

European Clinical Respiratory Journal

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“…The CHRONICLE study cohort is particularly important given the decentralized nature of severe asthma management by US subspecialists. With the potential to integrate data from CHRONICLE and ISAR, 15,16 US subspecialist patients with severe asthma will be better represented in a large global sample of patients with severe asthma. Potential benefits of pooling data across multiple national registries include enhanced accuracy of epidemiologic estimates, improved recognition of rare events, and greater ability to examine possible drug-demographic, drug-disease, and drug-drug interactions in various subpopulations.…”

Section: Discussionmentioning

confidence: 99%

“…CHRONICLE data collection was aligned with ISAR core data collection 16 to capture core asthma-related variables and ensure that ISAR and CHRONICLE data can be merged to create a larger global dataset. However, additional data elements collected in CHRONICLE enable a more complete characterization of HCPs and patients, including information on important potential confounders of patient health outcomes.…”

Section: Study Conductmentioning

confidence: 99%

“…15 A panel of 27 international asthma experts used a modified Delphi process to reach a consensus on a common set of 95 core variables for standardized collection across all participating countries. 16 ISAR chose to focus on the population of adult patients receiving monoclonal antibody or maintenance systemic corticosteroid treatment, or those uncontrolled while receiving high-dosage ICS with additional controllers. At present, only a single US site is involved in ISAR.…”

Section: Introductionmentioning

confidence: 99%

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<p>The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results</p>

Ambrose

Chipps²,

Moore³

et al. 2020

POR

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Background: Approximately 5-10% of patients with asthma have severe disease. Highquality real-world studies are needed to identify areas for improved management. Objective: Aligned with the International Severe Asthma Registry, the CHRONICLE study (ClinicalTrials.gov: NCT03373045) was developed to address this need in the US. Study Design: Learnings from prior studies were applied to develop a real-world, prospective, noninterventional study of US patients with confirmed severe asthma who are treated by subspecialist physicians and require biologic or maintenance systemic immunosuppressant therapy or who are uncontrolled by high-dosage inhaled corticosteroids and additional controllers. Target enrollment is 4000 patients, with patient observation for ≥3 years. A geographically diverse sample of allergist/immunologist and pulmonologist sites approach all eligible patients under their care and report patient characteristics, treatment, and health outcomes every 6 months. Patients complete online surveys every 1-6 months. Initial Results: From February 2018 to February 2019, 102 sites screened 1428 eligible patients; 936 patients enrolled. Study sites (40% allergist/immunologist, 42% pulmonologist, 18% both) were similar to other US asthma subspecialist samples. Enrolled patients were 67% female with median ages at enrollment and diagnosis of 55 (range: 18-89) and 26 (0-80) years, respectively. Median body mass index was 31 kg/m 2 ; 3% and 29% were current or former smokers, respectively, and >60% reported ≥1 exacerbation in the prior year and suboptimal symptom control. Conclusion: CHRONICLE will provide high-quality provider-and patient-reported data from a large, real-world cohort of US adults with subspecialist-treated severe asthma.

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“…A modified Delphi consensus-driven approach [30] was used to develop a standardised set of core and research variables for ISAR [31]. The ISC will hold regular meetings to ensure continued expert input throughout the development and expansion of the registry, in terms of the collaborators and investigators added, as well as data collected.…”

Section: Registry Variablesmentioning

confidence: 99%

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

FitzGerald¹,

Tran

Alacqua

et al. 2020

BMC Med Res Methodol

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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 multidisciplinary 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 & Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders.

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Development of the International Severe Asthma Registry (ISAR): A Modified Delphi Study

Abstract: This is the first global attempt to generate an ISAR using a common set of core variables to ensure that data collected across all participating countries are standardized.

Cited by 45 publications

References 27 publications

The Danish severe asthma register: an electronic platform for severe asthma management and research

The Danish severe asthma register: an electronic platform for severe asthma management and research

<p>The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results</p>

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

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