University of Gothenburg Centre for Person-Centred Care, and Institute of Health and Care Sciences, University of Gothenburg, Gothenburg, Sweden
Department of Paediatrics, Södra Älvsborg Hospital, Region Västra Götaland, Borås, Sweden.
BMJ Open. 2021 May 4;11(5):e042726. doi: 10.1136/bmjopen-2020-042726.
This study protocol outlines the evaluation of the pictorial support in person-centred care for children (PicPecc). PicPecc is a digital tool used by children aged 5-17 years to self-report symptoms of acute lymphoblastic leukaemia, who undergo high-dose methotrexate treatments. The design of the digital platform follows the principles of universal design using pictorial support to provide accessibility for all children regardless of communication or language challenges and thus facilitating international comparison.
Both effect and process evaluations will be conducted. A crossover design will be used to measure the effect/outcome, and a mixed-methods design will be used to measure the process/implementation. The primary outcome in the effect evaluation will be self-reported distress. Secondary outcomes will be stress levels monitored via neuropeptides, neurosteroids and peripheral steroids indicated in plasma blood samples; frequency of in-app estimation of high levels of distress by the children; children's use of analgesic medicine and person centeredness evaluated via the questionnaire Visual CARE Measure. For the process evaluation, qualitative interviews will be carried out with children with cancer, their legal guardians and case-related healthcare professionals. These interviews will address experiences with PicPecc in terms of feasibility and frequency of use from the child's perspective and value to the caseworker. Interview transcripts will be analysed using an interpretive description methodology.
Ethical approval was obtained from the Swedish Ethical Review Authority (reference 2019-02392; 2020-02601; 2020-06226). Children, legal guardians, healthcare professionals, policymaking and research stakeholders will be involved in all stages of the research process according to Medical Research Council's guidelines. Research findings will be presented at international cancer and paediatric conferences and published in scientific journals.
ClinicalTrials.gov; NCT04433650.
本研究方案概述了以儿童为中心的关怀中的图像支持（PicPecc）的评估。PicPecc 是一种数字工具，用于 5-17 岁的儿童自我报告急性淋巴细胞白血病的症状，这些儿童接受高剂量甲氨蝶呤治疗。该数字平台的设计遵循通用设计原则，使用图像支持为所有儿童提供无障碍服务，无论他们是否存在沟通或语言挑战，从而促进国际比较。
将同时进行效果和过程评估。将使用交叉设计来衡量效果/结果，同时使用混合方法设计来衡量过程/实施。效果评估的主要结果将是自我报告的痛苦。次要结果将是通过神经肽、神经甾体和外周甾体监测的应激水平，这些物质在血浆血液样本中显示；儿童在应用程序中自我评估高度痛苦的频率；通过问卷调查 Visual CARE Measure 评估儿童的镇痛药物使用和以人为主导的程度。对于过程评估，将对癌症儿童、其法定监护人以及与病例相关的医疗保健专业人员进行定性访谈。这些访谈将从儿童的角度出发，讨论他们对 PicPecc 的体验，包括可行性和使用频率，以及对案例工作者的价值。访谈记录将使用解释性描述方法进行分析。
已从瑞典伦理审查局获得伦理批准（参考号 2019-02392；2020-02601；2020-06226）。根据医学研究委员会的指南，儿童、法定监护人、医疗保健专业人员、政策制定者和研究利益相关者将参与研究过程的所有阶段。研究结果将在国际癌症和儿科会议上展示，并发表在科学期刊上。
ClinicalTrials.gov；NCT04433650。
