Multi-level barriers faced and lessons learned to conduct a randomized controlled trial in patients with diabetes and prediabetes during the COVID-19 pandemic in Brazil
Lilian Pinto da Silva; Mariana Balbi Seixas; Ana Paula Delgado Bomtempo Batalha; Isabela Coelho Ponciano; Paul Oh; Gabriela Lima de Melo Ghisi
Resumo
Coronavirus disease 2019 (COVID-19) is a public health emergency of international concern. In March 2021, the number of confirmed cases worldwide reached 127,818,432, and Brazil ranked second among the countries with the highest number of confirmed cases (more than 12,573,615) and second in number of deaths worldwide . This pandemic is considered the most significant global health crisis of our time due to a high mortality rate associated with severe socioeconomic disruptions, educational institutions’ closures, shortages of medical supplies, and barriers for health systems and people, especially those living with chronic diseases such as diabetes .
Diabetes is considered a risk factor for COVID-19 progression and worse prognosis . People living with this health condition are warranted extra precautions, such as having at least a 30-day prescription supply and non-prescription medicines and having their healthcare provider’s phone number handy to connect if any concerns arise. Social distancing measures adopted as a strategy for the non-propagation and contamination of the virus caused difficulties for these patients to continue their treatments, which usually involve diabetes self-management education and support, dietary recommendations, and physical exercise . Therefore, these restrictions are leading to metabolic dysregulation and lack of control of coexisting cardiometabolic conditions in these patients.
References
1. World Health Organization – WHO [Internet]. 2021 [cited 2021 Mar 30]. Available from: https://www.who.int/
2. Coronavirus Resource Center Johns Hopkins. COVID-19 map [Internet]. 2021 [cited 2021 Mar 30]. Available from: https://coronavirus.jhu.edu/map.html
3. Chu IY, Alam P, Larson HJ, Lin L. Social consequences of mass quarantine during epidemics: a systematic review with implications for the COVID-19 response. J Travel Med. 2020;27(7):taaa192. http://dx.doi.org/10.1093/jtm/taaa192. PMid:33051660.
4. Guo W, Li M, Dong Y, Zhou H, Zhang Z, Tian C,etal. Diabetes is a risk factor for the progression and prognosis of COVID-19. Diabetes Metab Res Rev. 2020;36(7):e3319. http://dx.doi.org/10.1002/dmrr.3319. PMid:32233013.
5. Centers for Disease Control and Prevention – CDC. Certas condições médicas e risco de doença grave por COVID-19 [Internet]. 2021 [cited 2021 Mar 30]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html
6. Powers MA, Bardsley J, Cypress M, Duker P, Funnell MM, Fischl AH, et al. Diabetes Self-management education and support in type 2 diabetes: a joint position statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. J Acad Nutr Diet. 2015;115(8):1323-34. http://dx.doi.org/10.1016/j.jand.2015.05.012. PMid:26054423.
7. Angelidi AM, Belanger MJ, Mantzoros CS. Commentary: COVID-19 and diabetes mellitus: What we know, how our patients should be treated now, and what should happen next. Metabolism. 2020;107:154245. http://dx.doi.org/10.1016/j.metabol.2020.154245. PMid:32320742.
8. Mourad M, Bousleiman S, Wapner R, Gyamfi-Bannerman C. Conducting research during the COVID-19 pandemic. Semin Perinatol. 2020;44(7):151287. http://dx.doi.org/10.1016/j.semperi.2020.151287. PMid:32807490.
9. Kroenke K, Bair MJ, Sachs GA. Continuing research during a crisis. J Gen Intern Med. 2021;36(4):1086-8. http://dx.doi.org/10.1007/s11606-021-06636-5. PMid:33559063.
10. Singh P. The research community must meet the coronavirus disease 2019 challenge. Indian J Med Res. 2020;151(2-3):116-7. PMid:32270770.
11. Townsend E, Nielsen E, Allister R, Cassidy SA. Key ethical questions for research during the COVID-19 pandemic. Lancet Psychiatry. 2020;7(5):381-3. http://dx.doi.org/10.1016/S2215-0366(20)30150-4. PMid:32353264.
12. Horbach SPJM. Pandemic publishing: medical journals drastically speed up their publication process for Covid-19. bioRxiv. http://dx.doi.org/10.1101/2020.04.18.045963.
13. Fleming TR, Labriola D, Wittes J. Conducting clinical research during the COVID-19 pandemic: protecting scientific integrity. JAMA. 2020;324(1):33-4. http://dx.doi.org/10.1001/jama.2020.9286. PMid:32463422.
14. Ghisi GLM, Aultman C, Konidis R, Foster E, Sandison N, Alavinia M, et al. Development and validation of the DiAbeTes Education Questionnaire (DATE-Q) to measure knowledge among diabetes and prediabetes patients attending cardiac rehabilitation programs. J Cardiopulm Rehabil Prev. 2021;41(4):224-9. http://dx.doi.org/10.1097/HCR.0000000000000546. PMid:33512977.
15. Ghisi GLM, Seixas MB, Pereira DS, Cisneros LL, Ezequiel DGA, Aultman C, et al. Patient education program for Brazilians living with diabetes and prediabetes: findings from a development study. BMC Public Health. 2021 Jun 26;21(1):1236. http://dx.doi.org/10.1186/s12889-021-11300-y. PMid:34174860.
16. Bonsu JM, Frasso R, Curry AE. Lessons from the field: the conduct of randomized controlled trials in Botswana. Trials. 2017;18(1):503. http://dx.doi.org/10.1186/s13063-017-2237-4. PMid:29078791.
17. Contreras F, Sanchez M, Martinez MS, Castillo MC, Mindiola A, Bermudez V, et al. Management and Education in Patients with Diabetes Mellitus. Med Clin Rev. 2017;3(2):7. http://dx.doi.org/10.21767/2471-299X.1000049.
18. Peçanha T, Goessler KF, Roschel H, Gualano B. Social isolation during the COVID-19 pandemic can increase physical inactivity and the global burden of cardiovascular disease. Am J Physiol Heart Circ Physiol. 2020;318(6):H1441-6. http://dx.doi.org/10.1152/ajpheart.00268.2020. PMid:32412779.
19. Stokols D. Translating social ecological theory into guidelines for community health promotion. Am J Health Promot. 1996;10(4):282-98. http://dx.doi.org/10.4278/0890-1171-10.4.282. PMid:10159709.
20. McLaren L, Hawe P. Ecological perspectives in health research. J Epidemiol Community Health. 2005;59(1):6-14. http://dx.doi.org/10.1136/jech.2003.018044. PMid:15598720.
21. Lumeng JC, Chavous TM, Lok AS, Sen S, Wigginton NS, Cunningham RM. A risk–benefit framework for human research during the COVID-19 pandemic. Proc Natl Acad Sci USA. 2020;117(45):27749-53. http://dx.doi.org/10.1073/pnas.2020507117. PMid:33087558.
22. Babu AS, Arena R, Ozemek C, Lavie CJ. COVID-19: a time for alternate models in cardiac rehabilitation to take centre stage. Can J Cardiol. 2020;36(6):792-4. http://dx.doi.org/10.1016/j.cjca.2020.04.023. PMid:32344000.
23. Clark RA, Conway A, Poulsen V, Keech W, Tirimacco R, Tideman P. Alternative models of cardiac rehabilitation: a systematic review. Eur J Prev Cardiol. 2015;22(1):35-74. http://dx.doi.org/10.1177/2047487313501093. PMid:23943649.
Submitted date:
01/27/2021
Accepted date:
07/13/2021