Van den Broecke Maxim, de Jong Sarah, Kiasuwa Mbengi Régine, Vanroelen Christophe
Sciensano Cancer Centre, Brussel, Belgium
Vrije Universiteit Brussel, Brussel, Belgium.
BMJ Open. 2024 Dec 22;14(12):e087798. doi: 10.1136/bmjopen-2024-087798.
Living with a chronic disease impacts many aspects of life, including the ability to participate in activities that enable interactions with others in society, that is, social participation (SP). Despite efforts to monitor the quality of care and life of chronically ill people in Belgium, no disease-specific patient-reported measures (PRMs) have been used. These tools are essential to understand SP and to develop evidence-based recommendations to support its improvement. This protocol presents the phases for the disease-specific development of patient-reported outcome and experience measures to assess SP and its potential determinants among people living in Belgium with cancer, cystic fibrosis, diabetes, HIV or a neuromuscular disease.
This protocol applies the PROMIS Instrument Development and Validation Scientific Standards and COnsensus-based Standards for the selection of health Measurement INstruments to develop PRMs in a disease-specific manner to quantify the components of the International Classification of Functioning, Disability and Health (ICF). A mixed-method approach is used to create broad initial item pools based on patient (focus groups) and literature perspectives which are compared within ICF-standardised language by applying the refined ICF linking rules. An item set is first created based on this cross-matching exercise and then validated by multidisciplinary expert panels. Cognitive assessment and pilot testing are followed by the dissemination of the survey to a representative sample in Belgium. Advanced psychometric testing (classical test theory and item response theory) is applied to inform an item reduction strategy for the final measures and to develop scales for the ICF components.
Ethical approval was granted by the Ethics Committee of the Ghent University Hospital on 20 February 2023 to organise the patient focus groups (ONZ-2022-0470). Ethical approval for dissemination of the PRMs and psychometric testing will be sought at the Ghent University Hospital Ethics Committee at the start of Phase 6. Results will be disseminated through peer-reviewed journals and professional conferences.
患有慢性疾病会影响生活的许多方面，包括参与那些能够与社会中的其他人进行互动的活动的能力，即社会参与（SP）。尽管比利时已努力监测慢性病患者的护理质量和生活状况，但尚未使用针对特定疾病的患者报告指标（PRMs）。这些工具对于理解社会参与以及制定基于证据的建议以支持其改善至关重要。本方案介绍了针对特定疾病开发患者报告结局和体验指标的各个阶段，以评估比利时患有癌症、囊性纤维化、糖尿病、艾滋病毒或神经肌肉疾病的人群的社会参与及其潜在决定因素。
本方案应用PROMIS工具开发与验证科学标准以及基于共识的健康测量工具选择标准，以特定疾病的方式开发患者报告指标，从而量化国际功能、残疾和健康分类（ICF）的各个组成部分。采用混合方法，基于患者（焦点小组）和文献观点创建广泛的初始项目池，并通过应用完善的ICF链接规则，在ICF标准化语言范围内进行比较。首先基于这种交叉匹配练习创建一个项目集，然后由多学科专家小组进行验证。在进行认知评估和预试验之后，将调查分发给比利时的一个代表性样本。应用高级心理测量测试（经典测试理论和项目反应理论）为最终指标制定项目缩减策略，并为ICF各组成部分制定量表。
根特大学医院伦理委员会于2023年2月20日批准了组织患者焦点小组的伦理许可（ONZ - 2022 - 0470）。在第6阶段开始时，将向根特大学医院伦理委员会寻求传播患者报告指标和进行心理测量测试的伦理许可。研究结果将通过同行评审期刊和专业会议进行传播。
