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  1. K Hassan Murad,
  2. Noor Asi,
  3. Mouaz Alsawas,
  4. http://orcid.org/0000-0001-5481-696XFares Alahdab
  1. Rochester, Minnesota, U.s.a.
  1. Correspondence to : Dr 1000 Hassan Murad, Evidence-based Exercise Center, Mayo Clinic, Rochester, MN 55905, United states of america; murad.mohammad{at}mayo.edu

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  • EDUCATION & TRAINING (see Medical Teaching & Training)
  • EPIDEMIOLOGY
  • Full general MEDICINE (encounter Internal Medicine)

The first and earliest principle of evidence-based medicine indicated that a bureaucracy of evidence exists. Not all evidence is the same. This principle became well known in the early 1990s every bit practising physicians learnt basic clinical epidemiology skills and started to appraise and utilize evidence to their practice. Since evidence was described as a bureaucracy, a compelling rationale for a pyramid was fabricated. Evidence-based healthcare practitioners became familiar with this pyramid when reading the literature, applying evidence or teaching students.

Various versions of the show pyramid have been described, but all of them focused on showing weaker study designs in the bottom (basic science and case series), followed by instance–control and accomplice studies in the middle, then randomised controlled trials (RCTs), and at the very top, systematic reviews and meta-analysis. This description is intuitive and likely correct in many instances. The placement of systematic reviews at the top had undergone several alterations in interpretations, but was all the same thought of as an item in a hierarchy.i Most versions of the pyramid clearly represented a hierarchy of internal validity (chance of bias). Some versions incorporated external validity (applicability) in the pyramid by either placing N-1 trials above RCTs (considering their results are most applicable to private patients2) or by separating internal and external validity.3

Another version (the 6S pyramid) was also developed to describe the sources of show that can be used by testify-based medicine (EBM) practitioners for answering foreground questions, showing a hierarchy ranging from studies, synopses, synthesis, synopses of synthesis, summaries and systems.four This hierarchy may imply some sort of increasing validity and applicability although its master purpose is to emphasise that the lower sources of evidence in the bureaucracy are least preferred in do considering they require more expertise and time to identify, assess and utilise.

The traditional pyramid was deemed too simplistic at times, thus the importance of leaving room for statement and counterargument for the methodological merit of dissimilar designs has been emphasised.v Other barriers challenged the placement of systematic reviews and meta-analyses at the top of the pyramid. For case, heterogeneity (clinical, methodological or statistical) is an inherent limitation of meta-analyses that can be minimised or explained merely never eliminated.6 The methodological intricacies and dilemmas of systematic reviews could potentially result in dubiety and error.7 Ane evaluation of 163 meta-analyses demonstrated that the interpretation of treatment outcomes differed substantially depending on the belittling strategy being used.vii Therefore, we suggest, in this perspective, two visual modifications to the pyramid to illustrate two contemporary methodological principles (figure 1). We provide the rationale and an example for each modification.

Figure 1

Figure 1

The proposed new show-based medicine pyramid. (A) The traditional pyramid. (B) Revising the pyramid: (one) lines separating the study designs go wavy (Grading of Recommendations Cess, Evolution and Evaluation), (two) systematic reviews are 'chopped off' the pyramid. (C) The revised pyramid: systematic reviews are a lens through which bear witness is viewed (applied).

Rationale for modification 1

In the early 2000s, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group developed a framework in which the certainty in evidence was based on numerous factors and not solely on report design which challenges the pyramid concept.8 Study design lone appears to be bereft on its own as a surrogate for risk of bias. Sure methodological limitations of a study, imprecision, inconsistency and indirectness, were factors contained from written report pattern and can touch the quality of testify derived from any study design. For instance, a meta-analysis of RCTs evaluating intensive glycaemic control in non-critically ill hospitalised patients showed a non-pregnant reduction in bloodshed (relative risk of 0.95 (95% CI 0.72 to 1.25)9). Allocation concealment and blinding were not adequate in most trials. The quality of this bear witness is rated down due to the methodological imitations of the trials and imprecision (wide CI that includes substantial benefit and harm). Hence, despite the fact of having five RCTs, such evidence should not exist rated high in any pyramid. The quality of testify can also be rated up. For example, we are quite sure about the benefits of hip replacement in a patient with disabling hip osteoarthritis. Although not tested in RCTs, the quality of this testify is rated up despite the report blueprint (non-randomised observational studies).x

Therefore, the first modification to the pyramid is to change the direct lines separating study designs in the pyramid to wavy lines (going upwards and downward to reverberate the Class approach of rating up and down based on the various domains of the quality of evidence).

Rationale for modification 2

Some other challenge to the notion of having systematic reviews on the top of the evidence pyramid relates to the framework presented in the Journal of the American Medical Association User'south Guide on systematic reviews and meta-assay. The Guide presented a 2-pace approach in which the credibility of the process of a systematic review is evaluated first (comprehensive literature search, rigorous written report pick process, etc). If the systematic review was deemed sufficiently credible, then a second step takes place in which we evaluate the certainty in prove based on the GRADE arroyo.11 In other words, a meta-analysis of well-conducted RCTs at low adventure of bias cannot be equated with a meta-analysis of observational studies at higher risk of bias. For example, a meta-analysis of 112 surgical case serial showed that in patients with thoracic aortic transection, the mortality charge per unit was significantly lower in patients who underwent endovascular repair, followed by open repair and non-operative management (ix%, xix% and 46%, respectively, p<0.01). Clearly, this meta-analysis should not be on top of the pyramid similar to a meta-analysis of RCTs. After all, the evidence remains consistent of non-randomised studies and probable subject area to numerous confounders.

Therefore, the second modification to the pyramid is to remove systematic reviews from the top of the pyramid and use them every bit a lens through which other types of studies should be seen (ie, appraised and applied). The systematic review (the process of selecting the studies) and meta-assay (the statistical aggregation that produces a single effect size) are tools to consume and utilize the evidence past stakeholders.

Implications and limitations

Changing how systematic reviews and meta-analyses are perceived past stakeholders (patients, clinicians and stakeholders) has important implications. For example, the American Heart Association considers evidence derived from meta-analyses to take a level 'A' (ie, warrants the most confidence). Re-evaluation of bear witness using Course shows that level 'A' prove could accept been high, moderate, low or of very depression quality.12 The quality of prove drives the strength of recommendation, which is one of the terminal translational steps of research, almost proximal to patient intendance.

One of the limitations of all 'pyramids' and depictions of evidence hierarchy relates to the underpinning of such schemas. The construct of internal validity may accept varying definitions, or be understood differently among bear witness consumers. A limitation of considering systematic review and meta-analyses as tools to consume show may undermine their role in new discovery (eg, identifying a new side effect that was non demonstrated in private studies13).

This pyramid can be too used as a teaching tool. EBM teachers can compare information technology to the existing pyramids to explain how certainty in the evidence (also called quality of bear witness) is evaluated. Information technology can exist used to teach how evidence-based practitioners can appraise and apply systematic reviews in practice, and to demonstrate the evolution in EBM thinking and the modernistic understanding of certainty in evidence.

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