Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Feb 21:15:1308418.
doi: 10.3389/fpsyg.2024.1308418. eCollection 2024.

Neuropsychological and biopsychosocial evolution, therapeutic adherence and unmet care needs during paediatric transplantation: study protocol of a mixed-methods design (observational cohort study and focus groups) - the TransplantKIDS mental health project

Jessica Garrido-Bolton  1 , Margarita Alcamí-Pertejo  1 , Rocío de la Vega  2   3 , Francisco Hernández-Oliveros  4 , Antonio Pérez-Martínez  5   6   7 , María Fe Bravo-Ortiz  1   6   8   9 , Eduardo Fernández-Jiménez  1   6   10
Affiliations

Neuropsychological and biopsychosocial evolution, therapeutic adherence and unmet care needs during paediatric transplantation: study protocol of a mixed-methods design (observational cohort study and focus groups) - the TransplantKIDS mental health project

Jessica Garrido-Bolton et al. Front Psychol. .

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).

Keywords: allogeneic hematopoietic transplantation; biopsychosocial model; children/adolescents; focus groups; neuropsychological outcomes; observational cohort design; organ transplantation.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.

Figures

Figure 1
Figure 1
Flow diagram for study design. Study phases and outcome measures.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Alonso E. M., Sorensen L. G. (2009). Cognitive development following pediatric solid organ transplantation. Curr. Opin. Organ Transplant. 14, 522–525. doi: 10.1097/MOT.0b013e3283307a62, PMID: - DOI - PubMed
    1. Amatya K., Monnin K., Steinberg Christofferson E. (2021). Psychological functioning and psychosocial issues in pediatric kidney transplant recipients. Pediatr. Transplant. 25:e13842. doi: 10.1111/petr.13842, PMID: - DOI - PubMed
    1. Annema C., De Smet S., Castle E. M., Overloop Y., Klaase J. M., Janaudis-Ferreira T., et al. . (2023). European Society of Organ Transplantation (ESOT) consensus statement on Prehabilitation for solid organ transplantation candidates. Transpl. Int. 36:11564. doi: 10.3389/ti.2023.11564, PMID: - DOI - PMC - PubMed
    1. Badia X., Muriel C., Gracia A., Manuel Núñez-Olarte J., Perulero N., Gálvez R., et al. . (2003). Validación española del cuestionario Brief Pain Inventory en pacientes con dolor de causa neoplásica. Med. Clin. 120, 52–59. doi: 10.1016/S0025-7753(03)73601-X, PMID: - DOI - PubMed
    1. Bastos Tavares A. P., de Melo Guerra L. B. P., Jayme C. L. W., Porta G., de Melo Seixas R. B. P., de Carvalho E. (2022). Pediatric liver transplantation: caregivers’ quality of life. Pediatr Gastroenterol. Hepatol. Nutr. 25, 489–499. doi: 10.5223/pghn.2022.25.6.489, PMID: - DOI - PMC - PubMed

Associated data