
Wheel Replacing Pyramid: Better Paradigm Representing Totality of Evidence-Based Medicine
References
- Sackett DL. How to read clinical journals: I. Why to read them and how to start reading them critically. Can. Med Assoc J. 1981; 124(5): 555–558.
- Sackett DL, Rosenberg WMC, Gray MJA, Haynes BR, Richardson SW. Evidence-based medicine: What it is and what it isn’t. BMJ. 1996; 312(7023): 71–72. DOI: 10.1136/bmj.312.7023.71
- Guyatt GH, Sackett DL, Sinclair JC, et al. Users’ guides to the medical literature IX. A method for grading health care recommendations. JAMA. 1995; 274(22): 1800–1804. DOI: 10.1001/jama.1995.03530220066035
- Anglemyer A, Horvath HT, Bero L. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database Syst Rev. 2014; 2014(4): MR000034. DOI: 10.1002/14651858.MR000034.pub2
- Doidge N. Medicine’s Fundamentalists. Tablet Magazine; Aug 14, 2020. Accessed Nov 24, 2022.
https://www.tabletmag.com/sections/science/articles/randomized-control-tests-doidge . - Aldous C, Olfield P, Dancis J, Dancis B. New approach for evaluating evidence in a pandemic: The Totality of Evidence Wheel. Trial Site News; Oct 25, 2022. Accessed Aug 19, 2023.
https://www.trialsitenews.com/a/new-approach-for-evaluating-evidence-in-a-pandemic-the-totality-of-evidence-wheel-abff2a0c . - Aldous C, Olfield P, Dancis J, Dancis B. The Totality of EBM still points to the efficacy of ivermectin in COVID-19: The Totality of Evidence–Based Medicine Wheel. BizNews; Oct 27, 2022. Accessed Aug 19, 2023.
https://www.biznews.com/health/2022/10/27/ivermectin-ebm - NIH NLM Home Page PubMed®. Accessed Jun 1, 2022 to Oct 3, 2022.
https://pubmed.ncbi.nlm.nih.gov/ . - Tablets: Stromectol® (Ivermectin). US FDA. (NDA 50-742/S-022); Sept 12, 2008. Accessed Sept 22, 2022.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050742s022lbl.pdf . - de Castro CG
Jr. , Gregianin LJ, Burgerd JA. Continuous high-dose ivermectin appears to be safe in patients with acute myelogenous leukemia and could inform clinical repurposing for COVID-19 infection. Leuk Lymphoma. 2020; 61(10): 2536–2537. DOI: 10.1080/10428194.2020.1786559 - Santin AD, Scheim DE, McCullough PA, Yagisawa M, Borody TJ. Ivermectin: A multifaceted drug of Nobel prize-honoured distinction with indicated efficacy against a new global scourge, COVID-19. New Microbes New Infect. 2021; 43: 100924. DOI: 10.1016/j.nmni.2021.100924
- VigiAccess. World Health Organisation. 2023. Accessed Jan 5, 2023.
https://vigiaccess.org/ . - Guzzo CA, Furtek CI, Porras AG, et al. Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects. J Clin Pharmacol. 2002; 42(10): 1122–1133. DOI: 10.1177/009127002237994
- Straus SE, Glasziou P, Richardson SW, Haynes BR. Evidence-Based Medicine: How to Practice and Teach EBM. 5th ed. Elsevier; 2018.
- Senate and House of Representatives of the United States of America. PUB255.PS-PLAW-114publ225.pdf. Dec 13, 2016; Accessed Dec 9, 2022.
https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf . - Deaton A, Cartwright N. Understanding and misunderstanding randomized controlled trials. Soc Sci Med. 2018, 210: 2–21. DOI: 10.1016/j.socscimed.2017.12.005
- Walach H, Falkenberg T, Fønnebø V, Lewith G, Jonas WB. Circular instead of hierarchical: Methodological principles for the evaluation of complex interventions. BMC Med Res Methodol. 2006; 6: Article 29. DOI: 10.1186/1471-2288-6-29
- Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987; 317: 141–145. DOI: 10.1056/NEJM198707163170304
- Enkin MW, Jadad AR. Using anecdotal information in evidence-based health care: heresy or necessity? Ann Oncol. 1998; Sep(9): 963–966. DOI: 10.1023/A:1008495101125
- Stone, HA. CURE ID: Capturing Clinician’s Experiences Repurposing Drugs to Inform Future Studies in the Era of COVID-19.
https://www.fda.gov/media/138725/download . Accessed Sep 21, 2023. - Frieden TR. Evidence for health decision making — Beyond randomized, controlled trials. N Engl J Med. 2017; 377: 465–475. DOI: 10.1056/NEJMra1614394
- The 2015 Nobel Prize in Physiology or Medicine, Press release, Solna, Sweden: The Nobel Assembly at Karolinska Institutet. October 5, 2015. Accessed: September 11, 2023.
https://www.nobelprize.org/prizes/medicine/2015/press-release/ . - Jans DA, Wagstaff KM. The broad spectrum host-directed agent ivermectin as an antiviral for SARS-CoV-2? Biochem Biophys Res Commun. 2021; 538: 163–172. DOI: 10.1016/j.bbrc.2020.10.042
- Zaidi AK, Dehgani-Mobaraki P. The mechanisms of action of ivermectin against SARS-CoV-2 – An extensive review. J. Antibiot. 2022; 75: 60–71. DOI: 10.1038/s41429-021-00491-6
- Song P, Li W, Xie J, Hou Y, You C. Cytokine storm induced by SARS-CoV-2. Clinica Chimica Acta. 2020; 509: 280–228. DOI: 10.1016/j.cca.2020.06.017
- Costela-Ruiz VJ, Illescas-Montes R, Puerta-Puerta JM, Ruiz C, Melguizo-Rodríguez L. SARS-CoV-2 infection: The role of cytokines in COVID-19 disease. Cytokine Growth Factor Rev. 2020; 54: 62–75. DOI: 10.1016/j.cytogfr.2020.06.001
- Thepmankorn P, Bach J, Lasfar A, et al. Cytokine storm induced by SARS-CoV-2 infection: The spectrum of its neurological manifestations. Cytokine. 2021; 138: 155404. DOI: 10.1016/j.cyto.2020.155404
- Rajter JC, Sherman MS, Fatteh N, Vogel F, Sacks J, Rajter JJ. Use of ivermectin is associated with lower mortality in hospitalized patients with coronavirus disease 2019. Chest. 2020; 159(1): 85–92. DOI: 10.1016/j.chest.2020.10.009
- Stone, JC, Ndarukwa P, Scheim DE, et al. Changes in SpO2 on room air for 34 severe COVID-19 patients after ivermectin based combination treatment: 62% normalization within 24 hours. Biologics. 2022; 2: 196–210. DOI: 10.3390/biologics2030015
- Hazan, et al. Effectiveness of Ivermectin-based multidrug therapy in severe hypoxic ambulatory COVID-19 patients. Future Microbiol. 2022; 17(5): 339–350. DOI: 10.2217/fmb-2022-0014
- Babalola OE, Bode CO, Ajayi AA, Alakaloko FM, Akase IE, Otrofanowei E, Salu OB, Adeyemo WL, Ademuyiwa AO, Omilabu S. Ivermectin shows clinical benefits in mild to moderate COVID19: a randomized controlled double-blind, dose-response study in Lagos. QJM. 2022; 114(11): 780–788. DOI: 10.1093/qjmed/hcab035
- COVID-19 Treatment Guidelines Panel.
Coronavirus Disease 2019 (COVID-19) Treatment Guidelines . National Institutes of Health; July 21, 2023. Accessed July 27, 2023.https://files.covid19treatmentguidelines.nih.gov/guidelines/archive/covid19treatmentguidelines-04-29-2022.pdf - Vallejos J, Zoni R, Bangher M, et al. Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial. BMC Infect Dis. 2021; 21(1): 635. DOI: 10.1186/s12879-021-06348-5
- Lopez-Medina E, Lopez P, Hurtado IC, et al. Effect of ivermectin on time to resolution of symptoms among adults with mild COVID-19. A randomized clinical trial. JAMA. 2021; 325(14): 1426–1435. DOI: 10.1001/jama.2021.3071
- Reis G, Silva EASM, Silva DCM, et al. Effect of early treatment with ivermectin among patients with COVID-19. N Engl J Med. 2022; 386: 1721–1731. DOI: 10.1056/NEJMoa2115869
- Lim SC, Hor CP, Tay KH, et al. Efficacy of ivermectin treatment on disease progression among adults with mild to moderate covid-19 and comorbidities: The I-TECH randomized clinical trial. JAMA Intern Med. 2022; 182: 426–435. DOI: 10.1001/jamainternmed.2022.0189
- Chamie JJ, Hibberd JA, Scheim DE. COVID-19 excess deaths in Peru’s 25 states in 2020: Nationwide trends, confounding factors, and correlations with the extent of Ivermectin treatment by state. Cureus. 2023; 15(8):
e43168 . DOI: 10.7759/cureus.43168
DOI: https://doi.org/10.5334/aogh.4341 | Journal eISSN: 2214-9996
Language: English
Submitted on: Oct 9, 2023
Accepted on: Jan 20, 2024
Published on: Feb 29, 2024
Published by: Ubiquity Press
In partnership with: Paradigm Publishing Services
Publication frequency: 1 issue per year
Keywords:
© 2024 Colleen Aldous, Barry M. Dancis, Jerome Dancis, Philip R. Oldfield, published by Ubiquity Press
This work is licensed under the Creative Commons Attribution 4.0 License.