title: Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): rationale, design, and methods.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02150603.
authors.affiliation: KU Leuven - University of Leuven, Department of Public Health and Primary Care, B-3000 Leuven, Belgium.
authors.forename: Silke
authors.initials: S
authors.lastname: Apers
authors.affiliation: Toronto Congenital Cardiac Centre for Adults, Peter Munk Cardiac Centre, University Health Network, Toronto, Canada.
authors.forename: Adrienne H
authors.initials: AH
authors.lastname: Kovacs
authors.affiliation: KU Leuven - University of Leuven, School Psychology and Child and Adolescent Development, B-3000 Leuven, Belgium.
authors.forename: Koen
authors.initials: K
authors.lastname: Luyckx
authors.affiliation: Division of Cardiology, Hospital de Niños, Córdoba, Argentina.
authors.forename: Luis
authors.initials: L
authors.lastname: Alday
authors.affiliation: The Sahlgrenska Academy at University of Gothenburg, Institute of Medicine, Gothenburg, Sweden.
authors.forename: Malin
authors.initials: M
authors.lastname: Berghammer
authors.affiliation: KU Leuven - University of Leuven, University Hospitals Leuven, Division of Congenital and Structural Cardiology, B-3000 Leuven, Belgium.
authors.forename: Werner
authors.initials: W
authors.lastname: Budts
authors.affiliation: Department of Pediatric Cardiology and Adult with Congenital Heart Defect, IRCCS Policlinico San Donato, Milan, Italy.
authors.forename: Edward
authors.initials: E
authors.lastname: Callus
authors.affiliation: Department of Cardiology, Mater Dei Hospital, Birkirkara Bypass, Malta.
authors.forename: Maryanne
authors.initials: M
authors.lastname: Caruana
authors.affiliation: Frontier Lifeline Hospital (Dr. K. M. Cherian Heart Foundation), Chennai, India.
authors.forename: Shanthi
authors.initials: S
authors.lastname: Chidambarathanu
authors.affiliation: Adult Congenital Heart Disease Center, Heart Institute, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA, USA.
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Cook
authors.affiliation: 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.
authors.forename: Mikael
authors.initials: M
authors.lastname: Dellborg
authors.affiliation: Department of Adult Congenital Heart Disease, Chiba Cardiovascular Center, Chiba, Japan.
authors.forename: Junko
authors.initials: J
authors.lastname: Enomoto
authors.affiliation: Oslo University Hospital, Rikshospitalet, Oslo, Norway.
authors.forename: Katrine
authors.initials: K
authors.lastname: Eriksen
authors.affiliation: Stanford University, Department of Pediatrics and Medicine, Division of Pediatric Cardiology and Cardiovascular Medicine, Palo Alto, CA, USA.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Fernandes
authors.affiliation: Center for Biobehavioral Health, Nationwide Children's Hospital, Columbus, OH, USA.
authors.forename: Jamie L
authors.initials: JL
authors.lastname: Jackson
authors.affiliation: Department of Clinical Medicine and Public Health, Umeå University, Umeå, Sweden.
authors.forename: Bengt
authors.initials: B
authors.lastname: Johansson
authors.affiliation: Adult Congenital Heart Center, Montreal Heart Institute, Université de Montréal, Montreal, Canada.
authors.forename: Paul
authors.initials: P
authors.lastname: Khairy
authors.affiliation: University of Nebraska Medical Center/Children's Hospital and Medical Center, Omaha, NE, USA.
authors.forename: Shelby
authors.initials: S
authors.lastname: Kutty
authors.affiliation: Monash Heart, Monash Medical Centre, Monash University, Melbourne, Australia.
authors.forename: Samuel
authors.initials: S
authors.lastname: Menahem
authors.affiliation: Northern Alberta Adult Congenital Heart Clinic, University of Alberta, Edmonton, Canada.
authors.forename: Gwen
authors.initials: G
authors.lastname: Rempel
authors.affiliation: Academic Medical Center, Department of Cardiology, Amsterdam, The Netherlands.
authors.forename: Maayke A
authors.initials: MA
authors.lastname: Sluman
authors.affiliation: Hospital Louis Pradel, Lyon, France.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Soufi
authors.affiliation: University Hospital Bern, Center for Congenital Heart Disease, Bern, Switzerland.
authors.forename: Corina
authors.initials: C
authors.lastname: Thomet
authors.affiliation: Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Gruschen
authors.initials: G
authors.lastname: Veldtman
authors.affiliation: Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Jou-Kou
authors.initials: JK
authors.lastname: Wang
authors.affiliation: Washington University and Barnes Jewish Heart & Vascular Center, University of Missouri, Saint Louis, MO, USA.
authors.forename: Kamila
authors.initials: K
authors.lastname: White
authors.affiliation: 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.
authors.forename: Philip
authors.initials: P
authors.lastname: Moons
mesh_terms: D000328:Adult; D003430:Cross-Sectional Studies; D005260:Female; D006330:Heart Defects, Congenital / Q000175:diagnosis* / Q000453:epidemiology* / Q000628:therapy; D006801:Humans; D038622:Internationality; D008297:Male; D012107:Research Design / Q000592:standards; D057566:Self Report / Q000592:standards; D016896:Treatment Outcome
keywords: Adult; Congenital; Heart defects; International cooperation; Methods; Patient-reported outcomes