Adequacy of a Questionnaire for Evaluation of Radiopharmaceuticals-related Adverse Events: Cross-cultural Adaptation

Authors

  • Maria Carolina Peçanha Fernandes Universidade Federal Fluminense (UFF), Faculdade de Farmácia, Programa de Pós-Graduação Administração e Gestão da Assistência Farmacêutica. Niterói (RJ), Brasil. https://orcid.org/0000-0002-8899-1421
  • Mahanna Vanzeler Vaz Instituto Nacional de Câncer (INCA), Hospital de Câncer I (HC I). Rio de Janeiro (RJ), Brasil. https://orcid.org/0000-0002-9515-8817
  • Priscilla Brunelli Pujatti INCA, HC I, Serviço de Medicina Nuclear. Rio de Janeiro (RJ), Brasil. https://orcid.org/0000-0002-1165-8049
  • Sabrina Calil-Elias Universidade Federal Fluminense (UFF), Faculdade de Farmácia, Programa de Pós-Graduação Administração e Gestão da Assistência Farmacêutica. Niterói (RJ), Brasil. https://orcid.org/0000-0002-2026-1510

DOI:

https://doi.org/10.32635/2176-9745.RBC.2026v72n2.5542

Keywords:

Validation Study, Radiopharmaceuticals, Adverse Event, Nuclear Medicine, Patient Safety

Abstract

Introduction: Radiopharmaceuticals cause few adverse events that usually are underreported, negatively impacting the guidance provided to users. The lack of a specific tool for assessing radiopharmaceuticals adverse reactions in the patients’ perspective is a reality in Brazil. Objective: To carry out a cross-cultural adaptation and adapt a questionnaire to assess self-reported adverse events of radiopharmaceuticals by users of nuclear medicine. Method: Study of cultural appropriation and adequacy of the questionnaire carried out in a reference cancer hospital. Results: Translation, synthesis and backtranslation of the questionnaire titled ‘Experiences with Nuclear Medicine Examinations’ were performed. After this step, the entire process was analysed by eight expert judges who issued their informed opinions. Subsequently, ten users of the nuclear medicine service analysed the questionnaire and, based on the problems identified, the Delphi technique was implemented with ten experts. After a consensus was reached on the clarity and pertinence of the questions, the final version of the tool was created and applied to 211 participants, 18 of which reported at least one adverse event. Two of these were classified as possible and five as probable, according to the Silberstein causality. Conclusion: After the cross-cultural adaptation of the instrument to Portuguese, it was possible to apply it and obtain a satisfactory response about radiopharmaceuticals related adverse events.

Downloads

Download data is not yet available.

References

Schreuder N, Koopman D, Jager PL, et al. Adverse events of diagnostic radiopharmaceuticals: a systematic review. Semin Nucl Med. 2019;49(5):382-410. doi: https://doi.org/10.1053/j.semnuclmed.2019.06.006 DOI: https://doi.org/10.1053/j.semnuclmed.2019.06.006

Battal H, Ozer AY. Adverse reactions to radiopharmaceuticals: liver radiopharmaceuticals. Nucl Med Commun. 2021;42(4):352-9. doi: https://doi.org/10.1097/mnm.0000000000001355 DOI: https://doi.org/10.1097/MNM.0000000000001355

Silindir-Gunay M, Nur O. Adverse reactions to therapeutic radiopharmaceuticals. Appl Radiat Isot. 2024;214:111527. doi: https://doi.org/10.1016/j.apradiso.2024.111527 DOI: https://doi.org/10.1016/j.apradiso.2024.111527

Silindir-Gunay M, Karpuz M, Ozer AY. Targeted alpha therapy and nanocarrier approach. Cancer Biother Rad. 2020;35(6):446-58. doi: https://doi.org/10.1089/cbr.2019.3213 DOI: https://doi.org/10.1089/cbr.2019.3213

Rolfes L, van Hunsel F, Wilkes S, et al. Adverse drug reaction reports of patients and healthcare professionals-differences in reported information. Pharmacoepidemiol Drug Saf. 2015;24(2):152-8. doi: https://doi.org/10.1002/pds.3687 DOI: https://doi.org/10.1002/pds.3687

Almeida RS, Mamede M, Santos-Oliveira R. Pharmacovigilance of radiopharmaceuticals used for prostate and breast cancer in Brazil. Adv Drug React Bul. 2013;283(1):1091-4. doi: https://doi.org/10.1097/01.fad.0000439077.37093.a4 DOI: https://doi.org/10.1097/01.fad.0000439077.37093.a4

Schreuder N, Hoog Q, Vries ST, et al. Patient- reported adverse events of radiopharmaceuticals: development and validation of a questionnaire. Drug Saf. 2020;43(4):319-28. doi: https://doi.org/10.1007/s40264-019-00895-2 DOI: https://doi.org/10.1007/s40264-019-00895-2

Guillemin F. Cross-cultural adaptation and validation of heatth status measures. Scand J Rheumatol. 1995;24(2):61-3. doi: https://doi.org/10.3109/03009749509099285 DOI: https://doi.org/10.3109/03009749509099285

Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993;46(12):1417-32. doi: https://doi.org/10.1016/0895-4356(93)90142-n DOI: https://doi.org/10.1016/0895-4356(93)90142-N

Fundação de Pesquisa EuroQol [Internet]. Rotterdam: Euroqol, ©2026. EQ-5D-EL 2023; [sem data] [atualizado 2025 jan 21; citado 8 de janeiro de 2023]. Disponível em: https://euroqol.org/information-and-support/euroqol-instruments/eq-5d-3l/

Willis GB. Cognitive interviewing: a tool for improving questionnaire design. California: Sage Publications; 2005. 12. Conti MA, Slater B, Latorre MRDO. Validação e reprodutibilidade da escala de evaluación de insatisfación corporal para adolescentes. Rev Saúde Pública. 2009;43(3):515-24. doi: https://doi.org/10.1590/S0034-89102009000300016 DOI: https://doi.org/10.1590/S0034-89102009000300016

Marques JBV, Freitas D. Método delphi: caracterização e potencialidades na pesquisa em educação. Pro- Posições. 2018;29(2):389-415. doi: https://doi.org/10.1590/1980-6248-2015-0140

Scarparo AF, Laus AM, Azevedo ALCS, et al. Reflexões sobre o uso da técnica delphi em pesquisas na enfermagem. RENE. 2012;13(1):242-51. doi: https://doi.org/10.15253/2175-6783.20120001000025 DOI: https://doi.org/10.15253/2175-6783.20120001000025

Silberstein EB, Ryan J. Prevalence of adverse reactions in nuclear medicine. Pharmacopeia Committee of the Society of Nuclear Medicine. J Nucl Med. 1996;37(1):185-92.

Conselho Nacional de Saúde (BR). Resolução n° 466, de 12 de dezembro de 2012. Aprova as diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos [Internet]. Diário Oficial da União, Brasília, DF. 2013 jun 13 [acesso 2025 nov 15]; Seção I:59 Disponível em: https://bvsms.saude.gov.br/bvs/saudelegis/cns/2013/res0466_12_12_2012.html

Conselho Nacional de Saúde (BR). Resolução no 510, de 7 de abril de 2016. Dispõe sobre normas aplicáveis a pesquisas em Ciências Humanas e Sociais cujos procedimentos metodológicos envolvam dados diretamente obtidos com os participantes ou informações identificáveis ou que possam acarretar riscos maiores do que os existentes na vida cotidiana, na forma definida nesta Resolução [Internet]. Diário Oficial da União, Brasília, DF. 2016 maio 24 [acesso 2025 nov 15]; Seção 1:44. Disponível em: http://bvsms.saude.gov.br/bvs/saudelegis/cns/2016/res0510_07_04_2016.html

Bastos VCS, Carneiro AAL, Barbosa MSR, et al. Brazilian version of the Pediatric Functional Status Scale: translation and cross-cultural adaptation. Rev Bras Ter Intensiva. 2018;30(3)301-7. doi: https://doi.org/10.5935/0103-507x.20180043 DOI: https://doi.org/10.5935/0103-507X.20180043

Revicki DA, Gnanasakthy A, Weinfurt K. Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier. Qual Life Res. 2007;16(4):717-23. doi: https://doi.org/10.1007/s11136-006-9153-5 DOI: https://doi.org/10.1007/s11136-006-9153-5

Marques JBV, Freitas D. Método delphi: caracterização e potencialidades na pesquisa em Educação. Pro- Posições. 2018;29(2):389-415. doi: https://doi.org/10.1590/1980-6248-2015-0140 DOI: https://doi.org/10.1590/1980-6248-2015-0140

Almeida MA, Pergher AK, Canto DF. Validation of mapping of care actions prescribed for orthopedic patients onto the nursing interventions classification. Rev Lat Am Enfermagem. 2010;18(1):116-23. doi: https://doi.org/10.1590/s0104-11692010000100018 DOI: https://doi.org/10.1590/S0104-11692010000100018

Costa JA, Fugulin FMT. Atividades de enfermagem em centro de material e esterilização: contribuição para o dimensionamento de pessoal. Acta paul enferm. 2011;24(2):249-56. doi: https://doi.org/10.1590/S0103-21002011000200015 DOI: https://doi.org/10.1590/S0103-21002011000200015

Dini AP, Fugulin FMT, Veríssimo MDLOR, et al. Sistema de classificação de pacientes pediátricos: construção e validação de categorias de cuidados. Rev esc enferm USP. 2011;45(3):575-80. doi: https://doi.org/10.1590/S0080-62342011000300004 DOI: https://doi.org/10.1590/S0080-62342011000300004

Maia AES, Grello FAC, Cunha KC. Perfil sociodemográfico e clínico de pacientes com câncer cadastrados no programa de visita domiciliar de um hospital da rede pública. Rev Bras Cancerol. 2021;67(2):e- 05864. doi: https://doi.org/10.32635/2176-9745.RBC.2021v67n2.864 DOI: https://doi.org/10.32635/2176-9745.RBC.2021v67n2.864

Laroche ML, Quelven I, Mazère J, et al. Adverse reactions to radiopharmaceuticals in France: analysis of the national pharmacovigilance Database. Ann Pharmacother. 2015;49(1):39-47. doi: https://doi.org/10.1177/1060028014558153 DOI: https://doi.org/10.1177/1060028014558153

Silberstein EB. Prevalence of adverse events to radiopharmaceuticals from 2007 to 2011. J Nucl Med. 2014;55(8):1308-10. doi: https://doi.org/10.2967/jnumed.114.138057 DOI: https://doi.org/10.2967/jnumed.114.138057

Mititelu MR, Stanulovic V, Mitoi A, et al. Overview of adverse reactions of radiopharmaceuticals. Clin Oncol. 2025;43:103857. doi: https://doi.org/10.1016/j.clon.2025.103857 DOI: https://doi.org/10.1016/j.clon.2025.103857

Boynton PM, Greenhalgh T. Selecting, designing, and developing your questionnaire. BMJ. 2004;328(7451):1312-5. doi: https://doi.org/10.1136/bmj.328.7451.1312 DOI: https://doi.org/10.1136/bmj.328.7451.1312

Candido R, Silva JR, Coraiola JA, et al. Método delphi: uma ferramenta para uso em microempresas de base tecnológica. Revista da FAE [Internet]. 2007 [acesso 2026 jan 15];10(2):157-64. Disponível em: https://revistafae.fae.edu/revistafae/article/view/346/242

Agência IBGE Notícias [Internet]. Rio de Janeiro: IBGE; [sem data]. Censo 2022: proporção da população com nível superior completo aumenta de 6,8% em 2000 para 18,4% em 2022; 2025 fev 26 [atualizado 2026 fev 26; acesso 2025 dez 10]. Disponível em: https://agenciadenoticias.ibge.gov.br/agencia-noticias/2012-agencia-de-noticias/noticias/42742-censo-2022-proporcao-da-populacao-com-nivel-superior-completo-aumenta-de-6-8-em-2000-para-18-4-em-2022

Published

2026-04-09

How to Cite

1.
Fernandes MCP, Vaz MV, Pujatti PB, Calil-Elias S. Adequacy of a Questionnaire for Evaluation of Radiopharmaceuticals-related Adverse Events: Cross-cultural Adaptation. Rev. Bras. Cancerol. [Internet]. 2026 Apr. 9 [cited 2026 Jun. 15];72(2):e-215542. Available from: https://rbc.inca.gov.br/index.php/revista/article/view/5542

Issue

Section

ORIGINAL ARTICLE

Most read articles by the same author(s)