Are You Joking Dr. Lele?

Evidence-Based Medicine is a hot topic ever since the unpleasant and acrimonious spat between Swami Ramdev, also known as Baba Ramdev, of Patanjali and Dr. Jayesh Lele, MBBS, general secretary of the country’s largest lobby of allopathic doctors, the Indian Medical Association, or IMA was aired on 25 May 2021.

Lele seem to claim that COVID-19 treatment being undertaken in India by the allopathic doctors is Evidence-Based Medicine, which Ramdev was unwilling to accept due to very frequent and recurring changes in the allopathic treatment-protocols being practised, the preceding ones being abandoned citing lack of evidence while the succeeding ones being merely new conjectures.  Following the dictum that ‘absence of evidence’ is not the ‘evidence of presence’ let us dispassionately and objectively examine Lele’s claim.

The updated (revised and improved) definition of Evidence-Based Medicine is a systematic approach to clinical problem solving which allows the integration of the best available research evidence with clinical expertise and patient values. (David L. Sackett, Sharon E. Straus, W. Scott Richardson, William Rosenberg, and R. Brian Haynes. Evidence-Based Medicine: How To Practice And Teach EBM. 2nd edition, London: Churchill-Livingstone, 2000)

Speaking at the MLA 2010 Annual Conference, held in Washington DC, Mark Ebell, MD, MS, Associate Professor at the University of Georgia, and Editor-in-Chief, Essential Evidence Plus  defined Evidence-Based Practice as, “Making a conscientious effort to base clinical decisions on research that is most likely to be free from bias, and using interventions most likely to improve how long or well patients live.” (https://youtu.be/XWi7vNv2nos)

Evidence-based medicine includes three key components (see Figure): research-based evidence, clinical expertise (i.e., the clinician’s accumulated experience, knowledge, and clinical skills), and the patient’s values and preferences.

Practicing evidence-based medicine is advocated on the promise of improved quality, improved patient satisfaction, and reduced costs.

The EBM Pyramid (see figure) explains the knowledge types and the reliability of such evidence. Evidence in Level I is considered the gold standard of medical knowledge. Evidence in Level II comes from Controlled trials without randomization or Cohort or case-control analytic studies or multiple time series studies. It is often true that the best evidence available to clinicians is their own observed aggregate data. Evidence in Level III is based on expert opinion from experts who have narrowed their focus as much as possible about a complex area. Evidence in Level IV is based on personal experience. This is the least desirable source of evidence and lacks any statistical validity.

There is good evidence (e.g., from RCTs) and there is bad evidence (e.g., from personal experience). Then there’s evidence that falls in the grey area—neither clearly defined as good nor bad. It can be difficult for clinicians to know whether to use evidence in the grey area. To determine the validity of evidence, a team of clinicians with several years of experience in evidence-appraisal should review the knowledge in question. The team can then determine if the evidence is valid (i.e., accurate) and applicable (i.e., useful for the situation or population being considered).

COVID-19 is a fast moving epidemic with many uncertain parameters. In view of the lack of prior knowledge and urgency of the situation to have some understanding, clinicians and researchers worldwide are reporting rapid results in the form of Level III and Level IV evidence. There is no evidence at Level II or Level I about any treatment protocols at this time. These rapidly reported results are continuously changing as new insights on the SARS-CoV-2 virus and COVID-19 emerge.

The treatment protocols adopted by allopathy for treatment of COVID-19 have therefore been non- standardized, non-evidence-based protocols. They have been based on near real-time data, mostly of level IV and level III, to make care decisions with the sole objective of improving outcomes of treatment. Given the urgency for action, transparency, accountability, quality of care and value of care have expectedly taken a back seat.

Numerous preventative strategies and non-pharmaceutical interventions have been employed to mitigate the spread of disease including careful infection control, the isolation of patients, and social distancing. Management is predominantly focused on the provision of supportive care, with oxygen therapy representing the major treatment intervention. Medical therapy involving corticosteroids and antivirals have also been encouraged as part of critical management schemes.

The COVID-19 Treatment Guidelines have been developed by National Institutes of Health of the Government of the United States, to provide clinicians with guidance on how to care for patients with COVID-19. As per the official website these treatment guidelines were last updated on 27 May 2021. (https://www.covid19treatmentguidelines.nih.gov/introduction/ accessed on 06 June 2021). The recommendations in these Guidelines are based on scientific evidence and expert opinion. Each recommendation includes two ratings: an uppercase letter (A, B, or C) that indicates the strength of the recommendation [Rating of Recommendations: A = Strong; B = Moderate; C = Optional] and a Roman numeral with or without a lowercase letter (I, IIa, IIb, or III) that indicates the quality of the evidence that supports the recommendation [Rating of Evidence: I = One or more randomized trials without major limitations; IIa = other randomized trials or subgroup analyses of randomized trials; IIb = Nonrandomized trials or observational cohort studies; III = Expert opinion].

As on date, there is only one recommendation rated ‘AI’ for Managing Outpatients with COVID-19 while the most reliable of recommendations for Managing Patients in an Ambulatory Care Setting have not bettered the ‘AIII’ rating. Critical Care recommendations are still at rating B. Recommendations for managing hospitalised patients with varying severities of disease are still at ‘BIIa’ rating.

These guidelines have a clear disclaimer, “Rated treatment recommendations in these Guidelines should not be considered mandates. The choice of what to do or not to do for an individual patient is ultimately decided by the patient and their provider.”

The above facts clearly indicate that there is no evidence-based-practice or evidence-based-protocol for treatment of COVID-19 in the allopathic system. Based on frugal, confusing, rapidly changing and often low-quality data, clinicians are using and recommending their best educated guesses for treating COVID-19. It is true that an educated guessing is better than no guessing until such time that research becomes available but there is no evidence to show that an educated guess is any better than an uneducated guess.

Surely you are joking Dr. Jayesh Lele when you say that the treatment-protocols being practiced for treatment of COVID-19 is evidence-based-medicine. There is no harm however in your and your fellow members of IMA at least hearing C. Miller when he tells us, “why the practice of medicine is not science.” (Miller C. “Medicine Is Not Science: Guessing The Future, Predicting The Past” Journal of Evaluation in Clinical Practice, 2014, Vol 20, Issue 6, pp. 865-71).

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First published 06 June 2021

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Published by

Mukul Gupta

*Educator, researcher, author and a friendly contrarian* Professor@MDIGurgaon

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