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Int J Cardiol. 2015 Jan 20;179:334-42. doi: 10.1016/j.ijcard.2014.11.084. Epub 2014 Nov 8.

Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): rationale, design, and methods.

Author information

1
KU Leuven - University of Leuven, Department of Public Health and Primary Care, B-3000 Leuven, Belgium.
2
Toronto Congenital Cardiac Centre for Adults, Peter Munk Cardiac Centre, University Health Network, Toronto, Canada.
3
KU Leuven - University of Leuven, School Psychology and Child and Adolescent Development, B-3000 Leuven, Belgium.
4
Division of Cardiology, Hospital de Niños, Córdoba, Argentina.
5
The Sahlgrenska Academy at University of Gothenburg, Institute of Medicine, Gothenburg, Sweden.
6
KU Leuven - University of Leuven, University Hospitals Leuven, Division of Congenital and Structural Cardiology, B-3000 Leuven, Belgium.
7
Department of Pediatric Cardiology and Adult with Congenital Heart Defect, IRCCS Policlinico San Donato, Milan, Italy.
8
Department of Cardiology, Mater Dei Hospital, Birkirkara Bypass, Malta.
9
Frontier Lifeline Hospital (Dr. K. M. Cherian Heart Foundation), Chennai, India.
10
Adult Congenital Heart Disease Center, Heart Institute, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA, USA.
11
The Sahlgrenska Academy at University of Gothenburg, Institute of Medicine, Gothenburg, Sweden; Adult Congenital Heart Unit, Sahlgrenska University Hospital/Östra and Institute for Medicine, The Sahlgrenska Academy at University of Gothenburg, Sweden.
12
Department of Adult Congenital Heart Disease, Chiba Cardiovascular Center, Chiba, Japan.
13
Oslo University Hospital, Rikshospitalet, Oslo, Norway.
14
Stanford University, Department of Pediatrics and Medicine, Division of Pediatric Cardiology and Cardiovascular Medicine, Palo Alto, CA, USA.
15
Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.
16
Department of Clinical Medicine and Public Health, Umeå University, Umeå, Sweden.
17
Adult Congenital Heart Center, Montreal Heart Institute, Université de Montréal, Montreal, Canada.
18
University of Nebraska Medical Center/Children's Hospital and Medical Center, Omaha, NE, USA.
19
Monash Heart, Monash Medical Centre, Monash University, Melbourne, Australia.
20
Northern Alberta Adult Congenital Heart Clinic, University of Alberta, Edmonton, Canada.
21
Academic Medical Center, Department of Cardiology, Amsterdam, The Netherlands.
22
Hospital Louis Pradel, Lyon, France.
23
University Hospital Bern, Center for Congenital Heart Disease, Bern, Switzerland.
24
Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
25
Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan.
26
Washington University and Barnes Jewish Heart & Vascular Center, University of Missouri, Saint Louis, MO, USA.
27
KU Leuven - University of Leuven, Department of Public Health and Primary Care, B-3000 Leuven, Belgium; The Sahlgrenska Academy at University of Gothenburg, Institute of Medicine, Gothenburg, Sweden; The Heart Centre, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: philip.moons@kuleuven.be.

Abstract

BACKGROUND:

Data on patient-reported outcomes (PROs) in adults with congenital heart disease (CHD) are inconsistent and vary across the world. Better understanding of PROs and their differences across cultural and geographic barriers can best be accomplished via international studies using uniform research methods. The APPROACH-IS consortium (Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study) was created for this purpose and investigates PROs in adults with CHD worldwide. This paper outlines the project rationale, design, and methods.

METHODS/DESIGN:

APPROACH-IS is a cross-sectional study. The goal is to recruit 3500-4000 adults with CHD from 15 countries in five major regions of the world (Asia, Australia, Europe, North and South America). Self-report questionnaires are administered to capture information on PRO domains: (i) perceived health status (12-item Short-form Health Survey & EuroQOL-5D); (ii) psychological functioning (Hospital Anxiety and Depression Scale); (iii) health behaviors (Health-Behavior Scale-Congenital Heart Disease); and (iv) quality of life (Linear Analog Scale & Satisfaction With Life Scale). Additionally, potential explanatory variables are assessed: (i) socio-demographic variables; (ii) medical history (chart review); (iii) sense of coherence (Orientation to Life Questionnaire); and (iv) illness perceptions (Brief Illness Perception Questionnaire). Descriptive analyses and multilevel models will examine differences in PROs and investigate potential explanatory variables.

DISCUSSION:

APPROACH-IS represents a global effort to increase research understanding and capacity in the field of CHD, and will have major implications for patient care. Results will generate valuable information for developing interventions to optimize patients' health and well-being.

REGISTRATION:

ClinicalTrials.gov: NCT02150603.

KEYWORDS:

Adult; Congenital; Heart defects; International cooperation; Methods; Patient-reported outcomes

PMID:
25464481
DOI:
10.1016/j.ijcard.2014.11.084
[Indexed for MEDLINE]

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