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Rationale, design and methodology of APPROACH-IS II: International study of patient-reported outcomes and frailty phenotyping in adults with congenital heart disease

Lookup NU author(s): Dr Louise CoatsORCiD



This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


© 2022 The Author(s). Background: In recent years, patient-reported outcomes (PROs) have received increasing prominence in cardiovascular research and clinical care. An understanding of the variability and global experience of PROs in adults with congenital heart disease (CHD), however, is still lacking. Moreover, information on epidemiological characteristics and the frailty phenotype of older adults with CHD is minimal. The APPROACH-IS II study was established to address these knowledge gaps. This paper presents the design and methodology of APPROACH-IS II. Methods/design: APPROACH-IS II is a cross-sectional global multicentric study that includes Part 1 (assessing PROs) and Part 2 (investigating the frailty phenotype of older adults). With 53 participating centers, located in 32 countries across six continents, the aim is to enroll 8000 patients with CHD. In Part 1, self-report surveys are used to collect data on PROs (e.g., quality of life, perceived health, depressive symptoms, autonomy support), and explanatory variables (e.g., social support, stigma, illness identity, empowerment). In Part 2, the cognitive functioning and frailty phenotype of older adults are measured using validated assessments. Discussion: APPROACH-IS II will generate a rich dataset representing the international experience of individuals in adult CHD care. The results of this project will provide a global view of PROs and the frailty phenotype of adults with CHD and will thereby address important knowledge gaps. Undoubtedly, the project will contribute to the overarching aim of improving optimal living and care provision for adults with CHD.

Publication metadata

Author(s): Van Bulck L, Kovacs AH, Goossens E, Luyckx K, Zaidi A, Wang J-K, Yadeta D, Windram J, Van De Bruaene A, Thomet C, Thambo J-B, Taunton M, Sasikumar N, Sandberg C, Saidi A, Rutz T, Ortiz L, Mwita JC, Moon JR, Menahem S, Mattsson E, Mandalenakis Z, Mahadevan VS, Lykkeberg B, Leye M, Leong MC, Ladouceur M, Ladak LA, Kim Y, Khairy P, Kaneva A, Johansson B, Jackson JL, Giannakoulas G, Gabriel H, Fernandes SM, Enomoto J, Demir F, de Hosson M, Constantine A, Coats L, Christersson C, Cedars A, Caruana M, Callus E, Brainard S, Bouchardy J, Boer A, Baraona Reyes F, Areias ME, Araujo JJ, Andresen B, Amedro P, Ambassa J-C, Amaral F, Alday L, Moons P

Publication type: Article

Publication status: Published

Journal: International Journal of Cardiology

Year: 2022

Volume: 363

Pages: 30-39

Print publication date: 15/09/2022

Online publication date: 30/06/2022

Acceptance date: 27/06/2022

Date deposited: 28/07/2022

ISSN (print): 0167-5273

ISSN (electronic): 1874-1754

Publisher: Elsevier Ireland Ltd


DOI: 10.1016/j.ijcard.2022.06.064

PubMed id: 35780933


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Funder referenceFunder name
Children's Heart Unit Fund (, Newcastle upon Tyne through their funding of the CHUF Fontan nurse specialist
Maltese Cardiac Society
KU Leuven – University of Leuven, Research Foundation Flanders through grants 1159522N and 12E9819N
Swedish Heart and Lung Foundation through grant 20190525
Ricerca Corrente funding from the Italian Ministry of Health to IRCCS Policlinico San Donato
University Research Council of the Aga Khan University in Karachi in Pakistan