KU Leuven - University of Leuven, Leuven, Belgium; Research Foundation Flanders (FWO), Brussels, Belgium.
Oregon Health & Science University, Portland, OR, USA.
Int J Cardiol. 2022 Sep 15;363:30-39. doi: 10.1016/j.ijcard.2022.06.064. Epub 2022 Jun 30.
In recent years, patient-reported outcomes (PROs) have received increasing prominence in cardiovascular research and clinical care. An understanding of the variability and global experience of PROs in adults with congenital heart disease (CHD), however, is still lacking. Moreover, information on epidemiological characteristics and the frailty phenotype of older adults with CHD is minimal. The APPROACH-IS II study was established to address these knowledge gaps. This paper presents the design and methodology of APPROACH-IS II.
METHODS/DESIGN: APPROACH-IS II is a cross-sectional global multicentric study that includes Part 1 (assessing PROs) and Part 2 (investigating the frailty phenotype of older adults). With 53 participating centers, located in 32 countries across six continents, the aim is to enroll 8000 patients with CHD. In Part 1, self-report surveys are used to collect data on PROs (e.g., quality of life, perceived health, depressive symptoms, autonomy support), and explanatory variables (e.g., social support, stigma, illness identity, empowerment). In Part 2, the cognitive functioning and frailty phenotype of older adults are measured using validated assessments.
APPROACH-IS II will generate a rich dataset representing the international experience of individuals in adult CHD care. The results of this project will provide a global view of PROs and the frailty phenotype of adults with CHD and will thereby address important knowledge gaps. Undoubtedly, the project will contribute to the overarching aim of improving optimal living and care provision for adults with CHD.
近年来，患者报告的结局（PROs）在心血管研究和临床护理中受到越来越多的关注。然而，对于成人先天性心脏病（CHD）患者 PROs 的变异性和全球经验仍缺乏了解。此外，关于 CHD 老年患者的流行病学特征和脆弱表型的信息也很少。APPROACH-IS II 研究旨在解决这些知识空白。本文介绍了 APPROACH-IS II 的设计和方法学。
方法/设计：APPROACH-IS II 是一项全球性的多中心横断面研究，包括第 1 部分（评估 PROs）和第 2 部分（调查老年患者的脆弱表型）。该研究有 53 个参与中心，分布在六大洲的 32 个国家，旨在招募 8000 名 CHD 患者。在第 1 部分中，使用自我报告调查收集 PROs（如生活质量、感知健康、抑郁症状、自主支持）和解释变量（如社会支持、污名、疾病认同、赋权）的数据。在第 2 部分中，使用经过验证的评估工具测量老年人的认知功能和脆弱表型。
APPROACH-IS II 将生成一个代表成人 CHD 护理国际经验的丰富数据集。该项目的结果将提供一个全球视角的成人 CHD 患者的 PROs 和脆弱表型，并因此解决重要的知识空白。毫无疑问，该项目将有助于实现为 CHD 成人提供最佳生活和护理的总体目标。
