Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): Rationale, design, and methods
Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS): Rationale, design, and methods
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DOI：
10.1016/j.ijcard.2014.11.084
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发表时间：
2015-01-20
影响因子：
3.5
通讯作者：
Moons, Philip
中科院分区：
文献类型：
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作者：
Apers, Silke;Kovacs, Adrienne H.;Moons, Philip
背景：先天性心脏病 (CHD) 成人患者报告结果 (PRO) 的数据不一致，并且世界各地各不相同。最好通过使用统一研究方法的国际研究来更好地了解 PRO 及其跨越文化和地理障碍的差异。 APPROACH-IS 联盟（先天性心脏病成人患者报告结果模式评估 - 国际研究）就是为此目的而创建的，旨在调查全球先天性心脏病成人患者的 PRO。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。目标是招募来自世界五个主要地区（亚洲、澳大利亚、欧洲、北美和南美）15个国家的3500-4000名患有先心病的成年人。进行自我报告调查问卷以获取 PRO 领域的信息：(i) 感知的健康状况（12 项简短健康调查和 EuroQOL-5D）； (ii) 心理功能（医院焦虑和抑郁量表）； (iii) 健康行为（健康-行为量表-先天性心脏病）； (iv) 生活质量（线性模拟量表和生活满意度量表）。此外，还评估了潜在的解释变量：(i) 社会人口变量； (ii) 病史（图表审查）； (iii) 连贯感（生活取向问卷）； (iv) 疾病认知（简要疾病认知问卷）。描述性分析和多层次模型将检查 PRO 的差异并调查潜在的解释变量。讨论：APPROACH-IS 代表了全球为提高 CHD 领域的研究理解和能力而做出的努力，将对患者护理产生重大影响。结果将为制定干预措施以优化患者的健康和福祉提供有价值的信息。 (C) 2014 Elsevier Ireland Ltd. 保留所有权利。
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. (C) 2014 Elsevier Ireland Ltd. All rights reserved.