Garrido-Bolton Jessica, Alcamí-Pertejo Margarita, de la Vega Rocío, Hernández-Oliveros Francisco, Pérez-Martínez Antonio, Bravo-Ortiz María Fe, Fernández-Jiménez Eduardo
Department of Psychiatry, Clinical Psychology and Mental Health, La Paz University Hospital, Madrid, Spain.
Department of Personality, Evaluation and Psychological Treatment, University of Málaga, Málaga, Spain.
Front Psychol. 2024 Feb 21;15:1308418. doi: 10.3389/fpsyg.2024.1308418. eCollection 2024.
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 ( = 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).
本文描述了一项混合方法研究（观察性队列设计和焦点小组）的方案，旨在研究接受实体器官或同种异体造血移植的儿科患者在移植前和移植后阶段的神经心理功能及其他生物心理社会结果、治疗依从性和未满足的护理需求。采用多方法/多来源方法，将通过客观测试（SDMT、K-CPT 2/CPT 3、TAVECI/TAVEC、WISC-V/WAIS-IV词汇和数字广度子测试、语言流畅性测试、Stroop、ROCF和TONI-4）全面测量神经心理领域；通过问卷（家长/法定监护人报告：BRIEF-2和BASC-3；自我报告：BASC-3、BPI、PROMIS、AIQ和SMAQ）评估生态执行功能、情感和行为领域、疼痛强度/干扰、睡眠质量和治疗依从性；并从每位患者的病史中获取处方药的血液水平。这些结果将在移植前、移植后4周和6个月时进行测量。估计样本量为来自西班牙马德里拉巴斯大学医院的60名患者（任何类型的移植，实体器官或造血移植）。最后，将与患者、家长/监护人及移植临床医生组织三场焦点小组会议（共15人，每组5名参与者），以便定性确定该过程移植前和移植后阶段未满足的护理需求。该研究方案已在ClinicalTrials.gov（NCT05441436）注册。
