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Clinical Trial
. 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

Silke Apers  1 , Adrienne H Kovacs  2 , Koen Luyckx  3 , Luis Alday  4 , Malin Berghammer  5 , Werner Budts  6 , Edward Callus  7 , Maryanne Caruana  8 , Shanthi Chidambarathanu  9 , Stephen C Cook  10 , Mikael Dellborg  11 , Junko Enomoto  12 , Katrine Eriksen  13 , Susan M Fernandes  14 , Jamie L Jackson  15 , Bengt Johansson  16 , Paul Khairy  17 , Shelby Kutty  18 , Samuel Menahem  19 , Gwen Rempel  20 , Maayke A Sluman  21 , Alexandra Soufi  22 , Corina Thomet  23 , Gruschen Veldtman  24 , Jou-Kou Wang  25 , Kamila White  26 , Philip Moons  27 ; APPROACH-IS consortium; International Society for Adult Congenital Heart Disease (ISACHD)
Collaborators, Affiliations
Free article
Clinical Trial

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

Silke Apers et al. Int J Cardiol. .
Free article

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.

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