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Andrija Oliveira Almeida https://orcid.org/0000-0003-2130-724X

Thatiane Lopes Valentim Di Paschoale Ostolin https://orcid.org/0000-0002-8492-2840

Larissa Jucá de Moraes Sales https://orcid.org/0000-0001-5456-1709

Danielle Cristina Fonseca https://orcid.org/0000-0002-9667-918X

Maria das Graças Guerra Lessa https://orcid.org/0000-0001-8452-2962

Raira Pagano https://orcid.org/0000-0002-7663-1787

Ângela Cristine Bersch Ferreira https://orcid.org/0000-0003-3478-781X

Abstract

Randomized Clinical Trials (RCTs) have been consolidated as a paradigmatic and hegemonic model of level of evidence. However, an integrated quantitative and qualitative approach has gained visibility on the international agenda given its contributions to health research and practice. To discuss the epistemological challenges and empirical learning of qualitative research and the integration of clinical and qualitative data within the scope of the Brazilian Diabetes Prevention Program (PROVEN-DIA). This is an experience report on the epistemological challenges and empirical potential of conducting qualitative research (method: Comparative Case Study) and a clinical study (method: Multicenter Randomized Clinical Trial) in parallel within PROVEN-DIA. PROVEN-DIA is a lifestyle change program for diabetes prevention. From this perspective, the RCT aimed to evaluate the program's effectiveness, while the case study identified barriers and facilitators of the initiative. The main challenges identified included epistemological and methodological communication limits between researchers from a clinical and qualitative perspective, as well as aligning the timeframes of each methodological approach. The collaborative organization of the investigative process, mainly the synchronous online interactions inter-team interactions, and the incorporation of subjectivities identified through qualitative research into the Program's expansion and new phase of the RCT. Aligning demands and discourses was a need throughout the investigative process with communication as an essential strategy to address limitations and enable complementary qualitative and quantitative findings.  

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Section
Empirical Studies with Methodological Reflection

How to Cite

Oliveira Almeida, A., Lopes Valentim Di Paschoale Ostolin, T., Jucá de Moraes Sales, L., Fonseca, D. C., Guerra Lessa, M. das G., Pagano, R., & Bersch Ferreira, Â. C. (2025). METHODOLOGICAL PATH OF QUALITATIVE RESEARCH IN PROVEN-DIA CLINICAL RESEARCH: EPISTEMOLOGICAL CHALLENGES AND EMPIRICAL POTENTIALITIES. New Trends in Qualitative Research, 21(4), e1214. https://doi.org/10.36367/ntqr.21.4.2025.e1214
References

Aziz, Z., Mathews, E., Absetz, P., Sathish, T., Oldroyd, J., Balachandran, S., Shetty, S. S., Thankappan, K. R., & Oldenburg, B. (2018). A group-based lifestyle intervention for diabetes prevention in low- and middle-income country: Implementation evaluation of the Kerala Diabetes Prevention Program. Implementation Science, 13(1), 97.

Baixinho, C. L., Presado, M. H. C. V., & Oliveira, E. S. F. D. (2020). The place of qualitative research in Evidence-Based Practice. Revista Brasileira de Enfermagem, 73(5), e2020n5. https://doi.org/10.1590/0034-7167-2020730501

Bicudo, M. A. V., Mocrosky, L. F., Orlowski, N., Batista, J. O., & Pudelco, M. N. (2022). Data constitution in qualitative research with a phenomenological approach: Challenge in qualitative research in digital media. New Trends in Qualitative Research, 10, e523. https://doi.org/10.36367/ntqr.10.2022.e523

Brandão, E. R., & Ferreira, J. (2021). Apresentação: Tradição e perspectivas sobre a reflexividade em pesquisas etnográficas em saúde. In E. R. Brandão & J. Ferreira (Orgs.), Reflexividade na pesquisa antropológica em saúde: Desafios e contribuições para a formação de novos pesquisadores (pp. 15–45). Editora Universidade de Brasília. https://doi.org/10.26512/9786558460077.apres

Brasil. (2018). Lei nº 13.709, de 14 de agosto de 2018. Lei Geral de Proteção de Dados Pessoais (LGPD). Acesso em: http://www.planalto.gov.br/ccivil_03/_ato2015-2018/2018/lei/l13709.htm

Brasil. (2019). Lei nº 13.895, de 30 de outubro de 2019. Política Nacional de Prevenção do Diabetes e de Assistência Integral à Pessoa Diabética. Acesso em: http://www.planalto.gov.br/ccivil_03/_ato2019-2022/2019/lei/l13895.htm

Butt, M. D., Ong, S. C., Rafiq, A., Kalam, M. N., Sajjad, A., Abdullah, M., Malik, T., Yaseen, F., & Babar, Z.-U.-D. (2024). A systematic review of the economic burden of diabetes mellitus: Contrasting perspectives from high and low middle-income countries. Journal of Pharmaceutical Policy and Practice, 17(1), 2322107. https://doi.org/10.1080/20523211.2024.2322107

Campbell, M., Fitzpatrick, R., Haines, A., Kinmonth, A. L., Sandercock, P., Spiegelhalter, D., & Tyrer, P. (2000). Framework for design and evaluation of complex interventions to improve health. BMJ?: British Medical Journal, 321(7262), 694. https://doi.org/10.1136/bmj.321.7262.694

Chan, A.-W., Tetzlaff, J. M., Altman, D. G., Laupacis, A., Gøtzsche, P. C., Krleža-Jeri?, K., Hróbjartsson, A., Mann, H., Dickersin, K., Berlin, J. A., Doré, C. J., Parulekar, W. R., Summerskill, W. S. M., Groves, T., Schulz, K. F., Sox, H. C., Rockhold, F. W., Rennie, D., & Moher, D. (2013). SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Annals of Internal Medicine, 158(3), 200–207. https://doi.org/10.7326/0003-4819-158-3-201302050-00583

Conselho Nacional de Saúde (Brasil). (2011). Resolução nº 446 de 11 de agosto de 2011. Brasília, DF: Ministério da Saúde. Acesso em: https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?jornal=515&pagina=1&data=31/10/2019&totalArquivos=152

Conselho Nacional de Saúde (Brasil). (2016). Resolução nº 510, de 7 de abril de 2016. Brasília, DF: Ministério da Saúde. Acesso em: https://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/22917581

Creswell, J. W. (2014). Investigação qualitativa e projeto de pesquisa: Escolhendo entre cinco abordagens. Penso.

DiMartino, L., Carroll, A. J., Ridgeway, J. L., et al. (2025). Development of a method for qualitative data integration to advance implementation science within research consortia. Implementation Science Communications, 6, 21. https://doi.org/10.1186/s43058-025-00701-4

Eakin, J. M. (2021). Formando pesquisadores qualitativos críticos em saúde na terra dos ensaios clínicos randomizados. Em M. L. M. Bosi & D. M. Gastaldo (Orgs.), Tópicos avançados em pesquisa qualitativa em saúde: Fundamentos téorico-metodológicos. (p. p.282-313). Vozes.

Fetters, M. D., Curry, L. A., & Creswell, J. W. (2013). Achieving Integration in Mixed Methods Designs—Principles and Practices. Health Services Research, 48(6 Pt 2), 2134. https://doi.org/10.1111/1475-6773.12117

For the CNDDM Working Group, Toscano, C. M., Zhuo, X., Imai, K., Duncan, B. B., Polanczyk, C. A., Zhang, P., Engelgau, M., & Schmidt, M. I. (2015). Cost-effectiveness of a national population-based screening program for type 2 diabetes: The Brazil experience. Diabetology & Metabolic Syndrome, 7(1), 95. https://doi.org/10.1186/s13098-015-0090-8

Gibbs, G. (2009). Análise de dados qualitativos. Artmed.

Guetterman, T. C., Fetters, M. D., & Creswell, J. W. (2015). Integrating Quantitative and Qualitative Results in Health Science Mixed Methods Research Through Joint Displays. The Annals of Family Medicine, 13(6), 554–561. https://doi.org/10.1370/afm.1865

Janus, E. D., Best, J. D., Davis-Lameloise, N., et al. (2012). Scaling-up from an implementation trial to state-wide coverage: Results from the preliminary Melbourne Diabetes Prevention Study. Trials, 13, 152. https://doi.org/10.1186/1745-6215-13-152

Leon, A. C., Davis, L. L., & Kraemer, H. C. (2011). The role and interpretation of pilot studies in clinical research. Journal of Psychiatric Research, 45(5), 626–629. https://doi.org/10.1016/j.jpsychires.2010.10.008

Lindström, J., Louheranta, A., Mannelin, M., Rastas, M., Salminen, V., Eriksson, J., Uusitupa, M., & Tuomilehto, J.; Finnish Diabetes Prevention Study Group. (2003). The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care, 26(12), 3230–3236. https://doi.org/10.2337/diacare.26.12.3230

Magliano, D., Boyko, E. J., & IDF Diabetes Atlas 10th edition scientific committee. (2021). IDF Diabetes Atlas, 10th edn (10th edition). International Diabetes Federation.

Merhy, E. E. (2000). Um ensaio sobre o médico e suas valises tecnológicas: Contribuições para compreender as reestruturações produtivas do setor saúde. Interface - Comunicação, Saúde, Educação, 4(6), 109–116. https://doi.org/10.1590/S1414-32832000000100009

O’Cathain, A., Goode, J., Drabble, S. J., Thomas, K. J., Rudolph, A., & Hewison, J. (2014). Getting added value from using qualitative research with randomized controlled trials: A qualitative interview study. Trials, 15(1), 215. https://doi.org/10.1186/1745-6215-15-215

Penn, L., Rodrigues, A., Haste, A., Marques, M. M., Budig, K., Sainsbury, K., Bell, R., Araújo-Soares, V., White, M., Summerbell, C., Goyder, E., Brennan, A., Adamson, A. J., & Sniehotta, F. F. (2018). NHS Diabetes Prevention Programme in England: Formative evaluation of the programme in early phase implementation. BMJ Open, 8(2), e019467. https://doi.org/10.1136/bmjopen-2017-019467

Ramachandran, A., Snehalatha, C., Yamuna, A., Mary, S., & Ping, Z. (2007). Cost-Effectiveness of the Interventions in the Primary Prevention of Diabetes Among Asian Indians. Diabetes Care, 30(10), 2548–2552. https://doi.org/10.2337/dc07-0150

Rintamäki, R., Rautio, N., Peltonen, M., Jokelainen, J., Keinänen-Kiukaanniemi, S., Oksa, H., Saaristo, T., Puolijoki, H., Saltevo, J., Tuomilehto, J., Uusitupa, M., & Moilanen, L. (2021). Long-term outcomes of lifestyle intervention to prevent type 2 diabetes in people at high risk in primary health care. Primary Care Diabetes, 15(3), 444–450. https://doi.org/10.1016/j.pcd.2021.03.002

Sørensen, C. W., Sonne, C., Sacha, M., Kristiansen, M., Hannemose, S. Z., Stein, D. J., & Carlsson, J. (2023). Potential advantages of combining randomized controlled trials with qualitative research in mood and anxiety disorders—A systematic review. Journal of Affective Disorders, 325, 701–712. https://doi.org/10.1016/j.jad.2023.01.038

Souza, V. R. dos S., Marziale, M. H. P., Silva, G. T. R., & Nascimento, P. L. (2021). Tradução e validação para a língua portuguesa e avaliação do guia COREQ. Acta Paulista de Enfermagem, 34, eAPE02631. https://doi.org/10.37689/acta-ape/2021AO02631

Tatagiba, A. B. (2012). CRESWELL, John W. Projeto de pesquisa: Métodos qualitativo, quantitativo e misto; tradução Magda Lopes. – 3 ed. – Porto Alegre: ARTMED, 296 páginas, 2010. Cadernos de Linguagem e Sociedade, 13(1), 205–208. https://doi.org/10.26512/les.v13i1.11610

The Diabetes Prevention Program Research Group. (2002). Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. The New England Journal of Medicine, 346(6), 393–403. https://doi.org/10.1056/NEJMoa012512World Health Organization. (2024, November 14 - Diabetes. WHO. Acesso em: https://www.who.int/news-room/fact-sheets/detail/diabetes

Tong, A., Sainsbury, P., & Craig, J. (2007). Consolidated criteria for reporting qualitative research (COREQ): A 32-item checklist for interviews and focus groups. International Journal for Quality in Health Care, 19(6), 349–357. https://doi.org/10.1093/intqhc/mzm042

Yin, R. K. (2015). Qualitative research from start to finish (2nd ed.). Guilford Publications.

Zhang, W., & Creswell, J. (2013). The use of “mixing” procedure of mixed methods in health services research. Medical Care, 51(8), e51-57. https://doi.org/10.1097/MLR.0b013e31824642fd