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Abstract：
The present article describes the protocol of a mixed-methods study (an observational cohort design and focus groups), aimed to examine neuropsychological functioning and other biopsychosocial outcomes, therapeutic adherence and unmet care needs in paediatric population undergoing solid organ or allogeneic hematopoietic transplant during the pre- and post-transplant phases. Following a multi-method/multi-source approach, neuropsychological domains will be comprehensively measured with objective tests (SDMT, K-CPT 2/CPT 3, TAVECI/TAVEC, WISC-V/WAIS-IV Vocabulary and Digit Span subtests, Verbal Fluency tests, Stroop, ROCF, and TONI-4); ecological executive functioning, affective and behavioral domains, pain intensity/interference, sleep quality and therapeutic adherence will be assessed through questionnaires (parent/legal guardians-reported: BRIEF-2 and BASC-3; and self-reported: BASC-3, BPI, PROMIS, AIQ and SMAQ); and blood levels of prescribed drugs will be taken from each patient\'s medical history. These outcomes will be measured at pre-transplant and at 4-weeks and 6-months post-transplant phases. The estimated sample size was 60 patients (any type of transplant, solid organ, or hematopoietic) from La Paz University Hospital (Madrid, Spain). Finally, three focus group sessions will be organized with patients, parents/guardians, and transplant clinicians (n = 15, with 5 participants per group), in order to qualitatively identify unmet care needs during the pre-, and post-transplant stages of the process. The study protocol was registered at ClinicalTrials.gov (NCT05441436).
摘要：
本文介绍了混合方法研究的方案（观察性队列设计和焦点小组），旨在检查神经心理功能和其他生物心理社会结果，在移植前和移植后阶段接受实体器官或异基因造血移植的儿科人群中，治疗依从性和未满足的护理需求。遵循多方法/多源方法，神经心理学领域将通过客观测试(SDMT，K-CPT2/CPT3,TAVECI/TAVEC,WISC-V/WAIS-IV词汇和数字范围子测试，言语流畅性测试，Stroop,ROCF,和TONI-4)；生态执行功能，情感和行为领域，疼痛强度/干扰，睡眠质量和治疗依从性将通过问卷进行评估（父母/法定监护人报告：BRIEF-2和BASC-3；自我报告：BASC-3，BPI，PROMIS,AIQ和SMAQ）；处方药的血液水平将从每个患者的病史中获取。这些结果将在移植前以及移植后4周和6个月进行测量。估计样本量为60名患者(任何类型的移植，实体器官,或造血）来自拉巴斯大学医院（马德里，西班牙)。最后,将与患者组织三次焦点小组会议，父母/监护人,和移植临床医生(n=15，每组5名参与者)，为了定性地识别未满足的护理需求，和移植后的阶段。研究方案在ClinicalTrials.gov（NCT05441436）注册。
