先天性心脏病成人患者报告结局模式评估——国际研究（APPROACH-IS）：原理、设计与方法
Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): rationale, design, and methods.
作者信息
Apers Silke, Kovacs Adrienne H, Luyckx Koen, Alday Luis, Berghammer Malin, Budts Werner, Callus Edward, Caruana Maryanne, Chidambarathanu Shanthi, Cook Stephen C, Dellborg Mikael, Enomoto Junko, Eriksen Katrine, Fernandes Susan M, Jackson Jamie L, Johansson Bengt, Khairy Paul, Kutty Shelby, Menahem Samuel, Rempel Gwen, Sluman Maayke A, Soufi Alexandra, Thomet Corina, Veldtman Gruschen, Wang Jou-Kou, White Kamila, Moons Philip
机构信息
KU Leuven - University of Leuven, Department of Public Health and Primary Care, B-3000 Leuven, Belgium.
Toronto Congenital Cardiac Centre for Adults, Peter Munk Cardiac Centre, University Health Network, Toronto, Canada.
出版信息
Int J Cardiol. 2015 Jan 20;179:334-42. doi: 10.1016/j.ijcard.2014.11.084. Epub 2014 Nov 8.
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.
背景
关于先天性心脏病（CHD）成人患者报告结局（PROs）的数据并不一致，且在全球范围内存在差异。通过采用统一研究方法的国际研究，能够更好地理解PROs及其在文化和地理障碍方面的差异。为此成立了APPROACH - IS联盟（先天性心脏病成人患者报告结局模式评估 - 国际研究），以调查全球范围内CHD成人患者的PROs。本文概述了该项目的基本原理、设计和方法。
方法/设计：APPROACH - IS是一项横断面研究。目标是从世界五个主要地区（亚洲、澳大利亚、欧洲、北美洲和南美洲）的15个国家招募3500 - 4000名CHD成人患者。通过自我报告问卷收集有关PRO领域的信息：（i）感知健康状况（12项简短健康调查问卷和欧洲五维健康量表）；（ii）心理功能（医院焦虑抑郁量表）；（iii）健康行为（先天性心脏病健康行为量表）；以及（iv）生活质量（线性模拟量表和生活满意度量表）。此外，还评估潜在的解释变量：（i）社会人口统计学变量；（ii）病史（病历审查）；（iii）连贯感（生活取向问卷）；以及（iv）疾病认知（简短疾病认知问卷）。描述性分析和多水平模型将检验PROs的差异，并调查潜在的解释变量。
讨论
APPROACH - IS是一项旨在增强CHD领域研究理解和能力的全球努力，将对患者护理产生重大影响。研究结果将为制定优化患者健康和福祉的干预措施提供有价值的信息。
注册信息
ClinicalTrials.gov：NCT02150603
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