Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Jul 19;27(5):253-260.
doi: 10.1136/bmjebm-2022-111952. Online ahead of print.

Adapt or die: how the pandemic made the shift from EBM to EBM+ more urgent

Trisha Greenhalgh  1 , David Fisman  2 , Danielle J Cane  3 , Matthew Oliver  4 , Chandini Raina Macintyre  5
Affiliations

Adapt or die: how the pandemic made the shift from EBM to EBM+ more urgent

Trisha Greenhalgh et al. BMJ Evid Based Med. .

Abstract

Evidence-based medicine (EBM's) traditional methods, especially randomised controlled trials (RCTs) and meta-analyses, along with risk-of-bias tools and checklists, have contributed significantly to the science of COVID-19. But these methods and tools were designed primarily to answer simple, focused questions in a stable context where yesterday's research can be mapped more or less unproblematically onto today's clinical and policy questions. They have significant limitations when extended to complex questions about a novel pathogen causing chaos across multiple sectors in a fast-changing global context. Non-pharmaceutical interventions which combine material artefacts, human behaviour, organisational directives, occupational health and safety, and the built environment are a case in point: EBM's experimental, intervention-focused, checklist-driven, effect-size-oriented and deductive approach has sometimes confused rather than informed debate. While RCTs are important, exclusion of other study designs and evidence sources has been particularly problematic in a context where rapid decision making is needed in order to save lives and protect health. It is time to bring in a wider range of evidence and a more pluralist approach to defining what counts as 'high-quality' evidence. We introduce some conceptual tools and quality frameworks from various fields involving what is known as mechanistic research, including complexity science, engineering and the social sciences. We propose that the tools and frameworks of mechanistic evidence, sometimes known as 'EBM+' when combined with traditional EBM, might be used to develop and evaluate the interdisciplinary evidence base needed to take us out of this protracted pandemic. Further articles in this series will apply pluralistic methods to specific research questions.

Keywords: COVID-19; behavioral medicine; biomedical engineering; evidence-based practice.

PubMed Disclaimer

Conflict of interest statement

Competing interests: TG is a member of Independent SAGE and an unpaid adviser to Balvi, a philanthropic fund. RM in the last 5 years has received funding from Sanofi and Seqirus for investigator driven research on influenza vaccines. She has been on advisory boards or consulted for COVID-19 vaccines for Seqirus, Janssen and Astra-Zeneca. She has received funding for an industry-linkage grant scheme from mask manufacturer Detmold and consulted for mask manufacturer Ascend Performance Technologies. DF has served on advisory boards related to influenza and SARS-CoV-2 vaccines for Seqirus, Pfizer, Astrazeneca and Sanofi-Pasteur Vaccines, and has served as a legal expert on issues related to COVID-19 epidemiology for the Elementary Teachers Federation of Ontario and the Registered Nurses Association of Ontario. DJC worked as a Clinical Specialist for the Canadian PPE Manufacturers Association between November 2021 and February 2022. She now serves as an executive board member with the Coalition of Healthcare Associated Infection Reduction (CHAIR), a volunteer, not-for-profit group, and is a co-founder of the volunteer grassroots group Community Access to Ventilation Information (CAVI) supporting public library CO2 monitor loaning programmes.

Figures

Figure 1
Figure 1
One version of EBM’s hierarchy of evidence, showing evolution over time to encourage a more flexible approach. (Reproduced under CC-BY-4.0 Licence from Murad et al 4). EBM, evidence-based medicine.
Figure 2
Figure 2
Combining controlled trials with evaluation of real-world action via case studies. (Reproduced and adapted under CC-BY-4.0 Licence from Ogilvie et al 43). RCT, randomised controlled trial.
See this image and copyright information in PMC

References

    1. Tresker S. Treatment Effectiveness and the Russo–Williamson Thesis, EBM+, and Bradford Hill’s Viewpoints. Int Stud Philos Sci 2022;33:1–28. 10.1080/02698595.2022.2054396 - DOI
    1. Aronson JK, Auker-Howlett D, Ghiara V, et al. . The use of mechanistic Reasoning in assessing coronavirus interventions. J Eval Clin Pract 2021;27:684–93. 10.1111/jep.13438 - DOI - PMC - PubMed
    1. Parkkinen V-P, Wallmann C, Wilde M. Evaluating evidence of mechanisms in medicine: principles and procedures. Springer Nature, 2018. - PubMed
    1. Murad MH, Asi N, Alsawas M, et al. . New evidence pyramid. Evid Based Med 2016;21:125–7. 10.1136/ebmed-2016-110401 - DOI - PMC - PubMed
    1. Guyatt G, Cairns J, Churchill D, et al. . Evidence-Based medicine. A new approach to teaching the practice of medicine. JAMA 1992;268:2420–5. 10.1001/jama.1992.03490170092032 - DOI - PubMed