PMID- 37930773
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231123
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 12
DP  - 2023 Nov 6
TI  - Development of an Information Guideline for Kidney Transplant Recipients in a 
      Clinical Trial: Protocol for a Modified Delphi Method.
PG  - e46961
LID - 10.2196/46961 [doi]
LID - e46961
AB  - BACKGROUND: Renal transplantation is the treatment of choice for most cases of 
      end-stage renal disease. Recipients need to lead a healthy lifestyle to minimize 
      the potential side effects of immunosuppressive drugs and improve transplant 
      outcomes. There is not much evidence about the best way to increase adherence to 
      healthy lifestyles in kidney transplant recipients, so one of the objectives set 
      by the nursing team is to train people to acquire the necessary skills and tools 
      to be able to take care of themselves. In this sense, the consensual development 
      of appropriate materials may be useful and of interest. OBJECTIVE: The aim of 
      this study was to develop an information guide for adults with kidney transplants 
      to be assessed in a subsequent clinical trial as an intervention to increase 
      adherence to healthy habits. METHODS: We used a 3-step, methodological, 
      sequential approach: (1) training from a group of experts and item consensus; (2) 
      review of the medical literature available; and (3) use of the Delphi technique 
      with on-site meetings. A total of 5 nurses from the Community of Madrid Kidney 
      Transplantation Unit in Spain were asked to participate. The patients' lifestyle 
      factors that, according to the medical literature available and experts' 
      opinions, have the greatest impact on the survival of the transplanted organ and 
      the recipients themselves were all described. RESULTS: After using the modified 
      Delphi method to reach a consensus on the items to be included and the 
      information needed in each, an information guide for adult kidney transplant 
      patients was developed. This guide facilitates the structuring of health care, 
      information, and recommendations necessary for effective self-care for each 
      person. The result is considered to be an easy-to-understand tool, useful for 
      transplant doctors and nurses, in simple language, with information based on the 
      latest scientific-medical evidence published to date, aspects of which will be 
      evaluated in a clinical trial designed for this purpose. CONCLUSIONS: Currently, 
      this guide is the main intervention variable of a clinical trial (registered on 
      ClinicalTrials.gov; NCT05715580) aimed at improving compliance with healthy 
      habits in kidney transplant recipients in the Community of Madrid, Spain. The 
      method used in its development has been useful and agile, and the result is a 
      guide that can be easily updated periodically following the same procedure. 
      INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46961.
CI  - (c)Araceli Faraldo-Cabana, Ana Sanchez-Fructuoso, Isabel Perez-Flores, Juan Vicente 
      Beneit-Montesinos, Daniel Munoz-Jimenez, Belen Peix Jimenez, Sara Asensio 
      Arredondo, Enriqueta Isabel Nuno Santana, Maria Jose Santana Valeros, Virginia 
      Hidalgo Gonzalez, Fernando Gonzalez Garcia, Ismael Ortuno-Soriano. Originally 
      published in JMIR Research Protocols (https://www.researchprotocols.org), 
      06.11.2023.
FAU - Faraldo-Cabana, Araceli
AU  - Faraldo-Cabana A
AUID- ORCID: 0000-0001-9939-0034
AD  - Hospital Clinico San Carlos, Instituto de Investigacion Sanitaria San Carlos, 
      Madrid, Spain.
FAU - Sanchez-Fructuoso, Ana
AU  - Sanchez-Fructuoso A
AUID- ORCID: 0000-0001-7017-9729
AD  - Hospital Clinico San Carlos, Facultad de Medicina, Universidad Complutense de 
      Madrid, Instituto de Investigacion Sanitaria San Carlos, Madrid, Spain.
FAU - Perez-Flores, Isabel
AU  - Perez-Flores I
AUID- ORCID: 0000-0003-4644-1277
AD  - Hospital Clinico San Carlos, Facultad de Medicina, Universidad Complutense de 
      Madrid, Instituto de Investigacion Sanitaria San Carlos, Madrid, Spain.
FAU - Beneit-Montesinos, Juan Vicente
AU  - Beneit-Montesinos JV
AUID- ORCID: 0000-0002-7510-4408
AD  - Facultad de Enfermeria, Fisioterapia y Podologia, Universidad Complutense de 
      Madrid, Instituto de Investigacion Sanitaria San Carlos, Madrid, Spain.
FAU - Munoz-Jimenez, Daniel
AU  - Munoz-Jimenez D
AUID- ORCID: 0000-0003-4415-141X
AD  - Hospital Clinico San Carlos, Instituto de Investigacion Sanitaria San Carlos, Red 
      de Investigacion en Cronicidad, Atencion Primaria y Prevencion y Promocion de la 
      Salud. Unidad de Investigacion en Cuidados y Servicios de Salud del Instituto de 
      Salud Carlos III, Madrid, Spain.
FAU - Peix Jimenez, Belen
AU  - Peix Jimenez B
AUID- ORCID: 0000-0002-7651-3254
AD  - Hospital Clinico San Carlos, Madrid, Spain.
FAU - Asensio Arredondo, Sara
AU  - Asensio Arredondo S
AUID- ORCID: 0000-0003-1367-4824
AD  - Hospital Ramon y Cajal, Madrid, Spain.
FAU - Nuno Santana, Enriqueta Isabel
AU  - Nuno Santana EI
AUID- ORCID: 0000-0001-6939-9513
AD  - Hospital Doce de Octubre, Madrid, Spain.
FAU - Santana Valeros, Maria Jose
AU  - Santana Valeros MJ
AUID- ORCID: 0000-0003-3101-474X
AD  - Hospital La Paz, Madrid, Spain.
FAU - Hidalgo Gonzalez, Virginia
AU  - Hidalgo Gonzalez V
AUID- ORCID: 0000-0003-0967-7889
AD  - Hospital Ramon y Cajal, Madrid, Spain.
FAU - Gonzalez Garcia, Fernando
AU  - Gonzalez Garcia F
AUID- ORCID: 0000-0003-1786-0093
AD  - Hospital Gregorio Maranon, Madrid, Spain.
FAU - Ortuno-Soriano, Ismael
AU  - Ortuno-Soriano I
AUID- ORCID: 0000-0001-5651-8376
AD  - Facultad de Enfermeria, Fisioterapia y Podologia, Universidad Complutense de 
      Madrid, Instituto de Investigacion Sanitaria San Carlos, Madrid, Spain.
LA  - eng
SI  - ClinicalTrials.gov/NCT05715580
PT  - Journal Article
DEP - 20231106
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC10660209
OTO - NOTNLM
OT  - Delphi method
OT  - compliance
OT  - guideline
OT  - kidney transplantation
OT  - patient adherence
OT  - patients
COIS- Conflicts of Interest: None declared.
EDAT- 2023/11/06 12:41
MHDA- 2023/11/06 12:42
PMCR- 2023/11/06
CRDT- 2023/11/06 11:54
PHST- 2023/03/03 00:00 [received]
PHST- 2023/09/15 00:00 [accepted]
PHST- 2023/07/20 00:00 [revised]
PHST- 2023/11/06 12:42 [medline]
PHST- 2023/11/06 12:41 [pubmed]
PHST- 2023/11/06 11:54 [entrez]
PHST- 2023/11/06 00:00 [pmc-release]
AID - v12i1e46961 [pii]
AID - 10.2196/46961 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2023 Nov 6;12:e46961. doi: 10.2196/46961.