Rethinking the “Evidence Pyramid”: A shift From Positivism to Pragmatism
DOI:
https://doi.org/10.47203/IJCH.2025.v37i03.022Keywords:
Evidence hierarchy, Evidence pyramid, Pragmatism, Value Based MedicineAbstract
The evidence pyramid ranks study designs by their reliability in establishing causal relationships, with systematic reviews and RCTs at the top due to their ability to minimize bias. However, these studies may have limited external validity, as they often use controlled environments that don't reflect real-world conditions. Observational and quasi-experimental studies offer better external validity but have lower internal validity. The pyramid's structure is based on a positivist paradigm, which emphasizes on the objective truth and empirical methods. However, newer research methodologies recognize the complexity of real-world data and promote social justice and empowerment. The evidence pyramid's overfocus on internal validity may underappreciate external validity, and it often overlooks the importance of qualitative research. With increasing importance of value-based medicine, it is imperative to consider the subjective experiences of patients in informing policies and practices. To address these issues, we have proposed the Evidence Pie model, where all study designs contribute to evidence, with quality of the evidence being determined by rigor rather than design type. This simplistic, single-layered model aims to integrate diverse evidence types for more practical, context-sensitive decision-making.
Downloads
References
NSW Department of Communities and Justice. What is evidence? (Internet). Available from: https://dcj.nsw.gov.au/content/dcj/evidenceportal/evidence-portal-home/using-evidence/what-is-evidence
Greenhalgh T, Russell J. Evidence-based policymaking: a critique. Perspect Biol Med. 2009;52(2):304-18. doi:10.1353/pbm.0.0085.
Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ. 1996;312(7023):71-72.
Guyatt G, Rennie D, Meade MO, Cook DJ. Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. 3rd ed. McGraw-Hill Education; 2015.
Rothwell PM. External validity of randomised controlled trials: "To whom do the results of this trial apply?". Lancet. 2005;365(9453):82-93
Shadish WR, Cook TD, Campbell DT. Experimental and Quasi-Experimental Designs for Generalized Causal Inference. Houghton Mifflin; 2002
Jackson S, Fazal N, Giesbrecht N. A hierarchy of evidence: which intervention has the strongest evidence of effectiveness. Canadian Best Practices Portal for Health Promotion and Chronic Disease Prevention. 2010.
Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0. The Cochrane Collaboration; 2011.
Pearl J. Causality: Models, Reasoning, and Inference. 2nd ed. Cambridge University Press; 2009.
Shadish WR, Cook TD, Campbell DT. Experimental and Quasi-Experimental Designs for Generalized Causal Inference. Houghton Mifflin; 2002.
Craig P, Cooper C, Gunnell D, Haw S, Lawson K, Macinty S, et al. Using natural experiments to evaluate population health interventions: new Medical Research Council guidance. J Epidemiol Community Health. 2012;66(12):1182-1186.
Lash TL, Fox MP, Fink AK. Applying Quantitative Bias Analysis to Epidemiologic Data. Springer; 2009.
Hernán MA, Robins JM. Causal Inference. Boca Raton: Chapman & Hall/CRC; 2020.
Gugnani N. Real world evidence: will the “pyramid” of evidence need some redefining…?.Evid Based Dent 25, 119–120 (2024). https://doi.org/10.1038/s41432-024-01035-1
Berlin JA, Golub RM Meta-analysis as evidence: building a better pyramid. JAMA 2014;312:603–5. doi:10.1001/jama.2014.8167
Dechartres A, Altman DG, Trinquart L, Boutron I, Ravaud P. Association between analytic strategy and estimates of treatment outcomes in meta-analyses. JAMA. 2014 Aug 13;312(6):623-30. doi: 10.1001/jama.2014.8166. PMID: 25117131.
Golder S, Loke YK, Bland M (2011) Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies: Methodological Overview. PLoS Med 8(5): e1001026. https://doi.org/10.1371/journal.pmed.1001026)
Ioannidis JPA. Why most published research findings are false. PLoS Med. 2005;2(8):e124
Greenhalgh T, Howick J, Maskrey N. Evidence based medicine: a movement in crisis? BMJ. 2014;348:g3725.
Borgetto B, Born S, Buenemann-Geissler D, Duechting M, Kahrs A M, Kasper N, et al. (2007). Die forschungspyramide: Diskussionsbeitrag zur evidenz-basierten praxis in der ergotherapie (The research pyramid: Contribution to the discussion of evidence-based practice in occupational therapy). Ergoscience, 2, 56–63. doi: 10.1055/s-2007-963004
Drazen JM, Harrington DP, McMurray JJ, Ware JH, Woodcock J, Ford I, Norrie J. Pragmatic Trials. N Engl J Med. 2016;375(5):454-463.
Berry SM, Carlin BP, Lee JJ, Muller P. Bayesian Adaptive Methods for Clinical Trials. CRC Press; 2010.
Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, et al. Real-World Evidence — What Is It and What Can It Tell Us? N Engl J Med. 2016;375(23):2293-2297.
Spiegelhalter DJ, Abrams KR, Myles JP. Bayesian Approaches to Clinical Trials and Health-Care Evaluation. Wiley; 2004.
Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342(25):1887-1892.
DiCenso, Bayley and Haynes (2009). ACP Journal Club. Editorial: Accessing pre-appraised evidence: Fine-tuning the 5S model into a 6S model. Annals of Internal Medicine, 151(6):JC3-2, JC3-3.
Murad MH, Asi N, Alsawas M, Alahdab F. New evidence pyramid. BMJ Evid Based Med. 2016;21:125-127
Gleser L, Hubbard R, Heagerty P. Statistical methods for analyzing data from clinical trials and observational studies. J Clin Epidemiol. 2006 Apr;59(4):403-409. doi: 10.1016/j.jclinepi.2005.09.017.
Jonas WB. The evidence house: how to build an inclusive base for complementary medicine. West J Med. 2001 Aug;175(2):79-80. doi: 10.1136/ewjm.175.2.79. PMID: 11483539; PMCID: PMC1071485.
Jacobs JA, Jones E, Gabella BA, Spring B, Brownson RC. Tools for Implementing an Evidence-Based Approach in Public Health Practice. Prev Chronic Dis 2012;9:110324. DOI: http://dx.doi.org/10.5888/pcd9.110324
Downloads
Published
How to Cite
License
Copyright (c) 2025 Pradeep Deshmukh, Priyanka Yadav, Amol Dongre

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
