Assessment of patterns of patient-reported outcomes in adults with congenital heart disease - International study (APPROACH-IS): Rationale, design, and methods
Journal
International Journal of Cardiology
Journal Volume
179
Pages
334-342
Date Issued
2015
Author(s)
Apers S.
Kovacs A.H.
Luyckx K.
Alday L.
Berghammer M.
Budts W.
Callus E.
Caruana M.
Chidambarathanu S.
Cook S.C.
Dellborg M.
Enomoto J.
Eriksen K.
Fernandes S.M.
Jackson J.L.
Johansson B.
Khairy P.
Kutty S.
Menahem S.
Rempel G.
Sluman M.A.
Soufi A.
Thomet C.
Veldtman G.
White K.
Moons P.
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. ? 2014 Elsevier Ireland Ltd. All rights reserved.
Subjects
Adult; Congenital; Heart defects; International cooperation; Methods; Patient-reported outcomes
SDGs
Other Subjects
13 item Orientation to Life Questionnaire; adult; alcohol consumption; Argentina; Article; Asia; Australia; Belgium; Brief Illness Perception Questionnaire; Canada; clinical study; confidentiality; congenital heart disease; controlled study; cross-sectional study; data analysis; demography; dental hygiene risk score; dental procedure; descriptive research; diseases; Europe; EuroQOL 5D 3 level; explanatory variable; France; health behavior; Health Behavior Scale Congenital Heart Disease; health status; Hospital Anxiety and Depression Scale; human; India; Italy; Japan; Linear Analog Scale and Satisfaction With Life Scale; linear analog score; major clinical study; Malta; medical history; Netherlands; Norway; Orientation to Life Questionnaire; patient care; patient reported outcome; perception; physical activity; physical exercise score; psychologic assessment; psychometry; quality control; quality of life; questionnaire; Satisfaction with Life Scale; scoring system; self report; sense of coherence; socioeconomics; South America; substance use risk score; Sweden; Switzerland; Taiwan; tobacco; total health risk score; United States; clinical trial; cross-sectional studies; female; Heart Defects, Congenital; Humans; Internationality; Male; multicenter study; Research Design; Self Report; standards; Treatment Outcome; Adult; Cross-Sectional Studies; Female; Heart Defects, Congenital; Humans; Internationality; Male; Research Design; Self Report; Treatment Outcome
Publisher
Elsevier Ireland Ltd
Type
journal article