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Peer-reviewedCC BYHematology, Transfusion and Cell Therapy

IDENTIFYING BARRIERS TO THE IMPLEMENTATION OF RECOMMENDED TESTING GUIDELINES IN CHRONIC LYMPHOCYTIC LEUKEMIA: A DELPHI SURVEY IN LATIN AMERICA

2 more authors
14 affiliations
  1. 1Laboratorio Barnafi Krause, Chile
  2. 2Laboratorio Oncogenomics, AUNA, Peru
  3. 3Clínica Los Nogales, Colombia
  4. 4Institute of Experimental Medicine (IMEX), CONICET, National Academy of Medicine (ANM), Argentina
  5. 5IMTIB, Hospital Italiano de Buenos Aires, Argentina
  6. 6Dr. José Eleuterio González University Hospital and School of Medicine, Universidad Autónoma de Nuevo León, Mexico
  7. 7Hospital Del Salvador, Chile
  8. 8Hematology Service, Instituto Guatemalteco de Seguridad Social (IGSS), Guatemala
  9. 9Centro de Diagnóstico Molecular y Estudios Genéticos (CEDIMEG), Costa Rica
  10. 10Laboratório de Biologia Molecular, Centro de Transplante de Medula Óssea (CEMO), Instituto Nacional de Câncer (INCA), Rio de Janeiro, RJ, Brazil
  11. 11Independent Medical Affairs and Strategy Consultant, Singapore
  12. 12AstraZeneca, United Arab Emirates
  13. 13Institute of Applied Biosciences-Centre for Research and Technology Hellas (INAB-CERTH), Greece
  14. 14Hematopathology Section, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Spain

Abstract

Background: While international recommendations for prognostic assessment in chronic lymphocytic leukemia (CLL) are well established, uptake and standardization of recommended molecular testing appears variable across Latin America, and regional or national consensus guidance is limited. Aim: A streamlined Delphi survey aimed to identify barriers and solutions to the adoption of guidelines for the early identification of patients with high-risk CLL. Methods: A modified Delphi process was used, engaging CLL experts from Latin America. A literature review informed a Round 1 survey, assessing the status of CLL prognostic testing in Latin America. Agreement statements were then developed and evaluated across two themes (Round 2 survey): core guideline-recommended prognostic tests, and barriers with actionable recommendations. Responses were rated on a scale of 1 to 10 (1 = completely disagree, 10 = completely agree); agreement was defined as ≥ 75% of respondents rating a statement ≥ 6, in all rounds. Results: Thirty-four experts from ten Latin American countries participated (May 2024 to December 2025), including hematologists, immuno-oncologists, molecular pathologists, clinical geneticists, and medical technologists. All experts completed the Round 2 survey; fifteen completed Round 1 which was then expanded to increase representation of the Latin America region. Agreement was achieved for 24 of 36 (67%) statements. Key statements for guideline-recommended tests achieving agreement included: ‘Unmutated IGHV genes and TP53 mutations are associated with high-risk CLL, and mutation analysis informs clinical decision making’ and ‘It is not necessary to repeat IGHV gene somatic hypermutation analysis after the initial test’. Key statements achieving consensus regarding recommendations included: ‘Local adaptation of international guidelines would support a standardized approach to prognostication for all patients’, ‘Increased education of primary care physicians on the availability of guideline-recommended prognostic tests and risk stratification is needed to ensure appropriate escalation of care to specialists’, ‘Pathologist training programs should be implemented to standardize methodology for prognostic testing’, and ‘National and international registries would support understanding of the status of prognostic testing for CLL and identify any unmet needs’. Additional solutions achieving agreement included improved communication between laboratories and oncologists, standardized reporting, established referral pathways, funding to support best practice sharing, patient education, and expanded access to clinical trials and prognostic technologies. Discussion: The survey highlighted the clinical importance of IGHV and TP53 as prognostic biomarkers and aligned on barriers to the implementation of guideline-recommended prognostic testing for CLL. Conclusion: Investment in testing capacity, education, and locally adapted guidelines is needed to improve the uptake of prognostic testing for patients with high-risk CLL in Latin America. This research was funded by AstraZeneca. Medical writing support, under the direction of the authors, was provided by Kate Rees, PhD, of Helios Medical Communications, part of Helios Global Group, and was funded by AstraZeneca in accordance with Good Publication Practice guidelines (http://www.ismpp.org/gpp-2022).

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BibTeX
@article{vargas2026identifying,
  title = {{IDENTIFYING BARRIERS TO THE IMPLEMENTATION OF RECOMMENDED TESTING GUIDELINES IN CHRONIC LYMPHOCYTIC LEUKEMIA: A DELPHI SURVEY IN LATIN AMERICA}},
  author = {Egon ÁLVAREZ VARGAS and Carolina BELMAR-LÓPEZ and Carlos CAMARGO MOLANO and Romina GAMBERALE and Hernán GARCÍA-RIVELLO and David GÓMEZ-ALMAGUER and Macarena ROA and Byron O SÁNCHEZ ROMERO and Carlos SANTAMARÍA-QUESADA and Ilana ZALCBERG-RENAULT and Ayman EL SAYES and Tamer AKL and Kostas STAMATOPOULOS and Dolors COLOMER},
  journal = {Hematology, Transfusion and Cell Therapy},
  year = {2026},
  month = oct,
  doi = {10.1016/j.htct.2026.107451},
  url = {https://doi.org/10.1016/j.htct.2026.107451},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - IDENTIFYING BARRIERS TO THE IMPLEMENTATION OF RECOMMENDED TESTING GUIDELINES IN CHRONIC LYMPHOCYTIC LEUKEMIA: A DELPHI SURVEY IN LATIN AMERICA
AU  - Egon ÁLVAREZ VARGAS
AU  - Carolina BELMAR-LÓPEZ
AU  - Carlos CAMARGO MOLANO
AU  - Romina GAMBERALE
AU  - Hernán GARCÍA-RIVELLO
AU  - David GÓMEZ-ALMAGUER
AU  - Macarena ROA
AU  - Byron O SÁNCHEZ ROMERO
AU  - Carlos SANTAMARÍA-QUESADA
AU  - Ilana ZALCBERG-RENAULT
AU  - Ayman EL SAYES
AU  - Tamer AKL
AU  - Kostas STAMATOPOULOS
AU  - Dolors COLOMER
PY  - 2026
DA  - 2026/10/23
JO  - Hematology, Transfusion and Cell Therapy
DO  - 10.1016/j.htct.2026.107451
UR  - https://doi.org/10.1016/j.htct.2026.107451
AB  - Background: While international recommendations for prognostic assessment in chronic lymphocytic leukemia (CLL) are well established, uptake and standardization of recommended molecular testing appears variable across Latin America, and regional or national consensus guidance is limited. Aim: A streamlined Delphi survey aimed to identify barriers and solutions to the adoption of guidelines for the early identification of patients with high-risk CLL. Methods: A modified Delphi process was used, engaging CLL experts from Latin America. A literature review informed a Round 1 survey, assessing the status of CLL prognostic testing in Latin America. Agreement statements were then developed and evaluated across two themes (Round 2 survey): core guideline-recommended prognostic tests, and barriers with actionable recommendations. Responses were rated on a scale of 1 to 10 (1 = completely disagree, 10 = completely agree); agreement was defined as ≥ 75% of respondents rating a statement ≥ 6, in all rounds. Results: Thirty-four experts from ten Latin American countries participated (May 2024 to December 2025), including hematologists, immuno-oncologists, molecular pathologists, clinical geneticists, and medical technologists. All experts completed the Round 2 survey; fifteen completed Round 1 which was then expanded to increase representation of the Latin America region. Agreement was achieved for 24 of 36 (67%) statements. Key statements for guideline-recommended tests achieving agreement included: ‘Unmutated IGHV genes and TP53 mutations are associated with high-risk CLL, and mutation analysis informs clinical decision making’ and ‘It is not necessary to repeat IGHV gene somatic hypermutation analysis after the initial test’. Key statements achieving consensus regarding recommendations included: ‘Local adaptation of international guidelines would support a standardized approach to prognostication for all patients’, ‘Increased education of primary care physicians on the availability of guideline-recommended prognostic tests and risk stratification is needed to ensure appropriate escalation of care to specialists’, ‘Pathologist training programs should be implemented to standardize methodology for prognostic testing’, and ‘National and international registries would support understanding of the status of prognostic testing for CLL and identify any unmet needs’. Additional solutions achieving agreement included improved communication between laboratories and oncologists, standardized reporting, established referral pathways, funding to support best practice sharing, patient education, and expanded access to clinical trials and prognostic technologies. Discussion: The survey highlighted the clinical importance of IGHV and TP53 as prognostic biomarkers and aligned on barriers to the implementation of guideline-recommended prognostic testing for CLL. Conclusion: Investment in testing capacity, education, and locally adapted guidelines is needed to improve the uptake of prognostic testing for patients with high-risk CLL in Latin America. This research was funded by AstraZeneca. Medical writing support, under the direction of the authors, was provided by Kate Rees, PhD, of Helios Medical Communications, part of Helios Global Group, and was funded by AstraZeneca in accordance with Good Publication Practice guidelines (http://www.ismpp.org/gpp-2022).
SN  - 2531-1379
SN  - 2531-1387
ER  -