TY - JOUR
T1 - Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): rationale, design, and methods
AU - Apers, Silke
AU - Kovacs, Adrienne H.
AU - Luyckx, Koen
AU - Alday, Luis
AU - Berghammer, Malin
AU - Budts, Werner
AU - Callus, Edward
AU - Caruana, Maryanne
AU - Chidambarathanu, Shanthi
AU - Cook, Stephen C.
AU - Dellborg, Mikael
AU - Enomoto, Junko
AU - Eriksen, Katrine
AU - Fernandes, Susan M.
AU - Jackson, Jamie L.
AU - Johansson, Bengt
AU - Khairy, Paul
AU - Kutty, Shelby
AU - Menahem, Samuel
AU - Rempel, Gwen
AU - Sluman, Maayke A.
AU - Soufi, Alexandra
AU - Thomet, Corina
AU - Veldtman, Gruschen
AU - Wang, Jou-Kou
AU - White, Kamila
AU - Moons, Philip
AU - AUTHOR GROUP
AU - Maisuls, Héctor
AU - Cabrera, Marcelo
AU - Eaton, Sarah
AU - Larion, Ruth
AU - FengWang, Qi
AU - van Deyk, Kristien
AU - Goossens, Eva
AU - Rassart, Jessica
AU - Mackie, Andrew
AU - Ballantyne, Ross
AU - Rankin, Kathryn
AU - Norris, Colleen
AU - Taylor, Dylan
AU - Vondermuhll, Isabelle
AU - Windram, Jonathan
AU - Heggie, Pamela
AU - Lasiuk, Gerri
AU - Proietti, Anna
AU - Dore, Annie
AU - Mercier, Lise-Andrée
AU - Mongeon, François-Pierre
AU - Marcotte, François
AU - Mulder, Barbara
PY - 2015
Y1 - 2015
N2 - 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. 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. 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. ClinicalTrials.gov: NCT02150603
AB - 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. 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. 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. ClinicalTrials.gov: NCT02150603
U2 - https://doi.org/10.1016/j.ijcard.2014.11.084
DO - https://doi.org/10.1016/j.ijcard.2014.11.084
M3 - Article
C2 - 25464481
SN - 0167-5273
VL - 179
SP - 334
EP - 342
JO - International journal of cardiology
JF - International journal of cardiology
ER -