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 Understanding Evidence Levels in Evidence-Based
Medicine: A Guide for Healthcare Professionals
Indunil Karunarathna 1 , K.Kusumarathna1 , P.Jayathilaka2 , B.Rathnayake 2 , S Bandara3 , M Abeykoon 4 , N Priyalath 5
,I
Gunarathna 6 , D Disanayake 7 , P Kurukulasooriya 7 , Achala Samarasinghe 8, Charaka Rathnayake9, C J Withanagama 10
1. Department of Anaesthesiology , Intensive Care and Pain Medicine, Teaching Hospital Badulla, Sri Lanka.
2. Department of Medicine, Teaching Hospital Badulla, Sri Lanka.
3. Accident Service, National Hospital Colombo, Sri Lanka.
4. Department of Microbiology, National Hospital Kandy, Sri Lanka.
5. Department of Emergency Medicine, Teaching Hospital Badulla, Sri Lanka.
6. Department of Anaesthesiology , Intensive Care and Pain Medicine, National Hospital Kandy, Sri Lanka.
7. Department of Surgery, Teaching Hospital Badulla, Sri Lanka.
8. Department of Surgery, Base Hospital Diyatalawa, Sri Lanka.
9. Department of Nephrology, Teaching Hospital Badulla, Sri Lanka.
10. Department of Cardiology, Teaching Hospital Badulla, Sri Lanka.

Abstract: In the realm of evidence-based medicine (EBM), understanding the hierarchy of evidence is paramount for healthcare
professionals to make informed clinical decisions. This article provides a comprehensive overview of evidence levels in EBM,
ranging from Level I, which comprises systematic reviews and meta-analyses of randomized controlled trials (RCTs), to Level V,
encompassing expert opinion and descriptive studies. Each evidence level is elucidated with examples and insights into its
significance in guiding clinical practice. By grasping the nuances of evidence levels, clinicians can critically appraise research
findings, integrate the best available evidence with clinical expertise and patient preferences, and ultimately optimize patient
care. This primer serves as a valuable resource for healthcare practitioners seeking to navigate the complex landscape of
evidence-based medicine.

Keywords: Levels of evidence, Evidence-based medicine, Randomized controlled trials, Systematic reviews, Clinical
recommendations, Research methodology, Bias, Specialty-specific evidence, Canadian Task Force, American Society of Plastic
Surgeons, Centre for Evidence-Based Medicine, Critical appraisal, Study design.

Key Points:  Understanding the levels of evidence helps clinicians and

 Levels of evidence were initially developed to assist in
grading the strength of recommendations based on
available research.
 The Canadian Task Force on the Periodic Health
Examination first introduced levels of evidence in 1979,
aiming to base health recommendations on the strength of
scientific evidence.
 The hierarchy of evidence typically places randomized
controlled trials (RCTs) at the highest level due to their
rigorous design and reduced risk of bias.
 Various organizations and journals have modified the
original levels of evidence to suit different specialties and
research questions, such as treatment, prognosis,
diagnosis, and economic analysis.
 The type and quality of evidence needed can vary
depending on the research question, with different study
designs being more appropriate for different types of
inquiries.
 The American Society of Plastic Surgeons (ASPS) and
the Centre for Evidence-Based Medicine (CEBM) are
examples of organizations that have developed their own
classifications of evidence tailored to their respective
fields.
researchers assess the quality and reliability of research
findings, informing clinical decision-making.
 It's essential to critically appraise research studies beyond
just their assigned level of evidence, considering factors
such as study design, methodology, and potential biases.
 While randomized controlled trials are often considered
the gold standard, poorly designed RCTs may yield
misleading results, highlighting the importance of careful
scrutiny and critical appraisal.
 Tailoring levels of evidence to specific specialties and
research questions ensures that recommendations are
based on the most relevant and reliable scientific
evidence available.
Introduction:
In the ever-evolving landscape of healthcare, the importance
of evidence-based medicine (EBM) cannot be overstated.
EBM integrates the best available research evidence with
clinical expertise and patient values to inform decision-making
and improve patient outcomes. Central to the concept of EBM
is the hierarchy of evidence, which categorizes research
studies based on their methodological rigor and quality.
Understanding evidence levels is crucial for healthcare
professionals to critically appraise research findings and make

Uva Clinical | Understanding Evidence Levels in Evidence-Based Medicine: A Guide for Healthcare Professionals 1
informed clinical decisions. In this article, we delve into the
different levels of evidence in EBM and their significance in
guiding clinical practice.
Level I Evidence: Systematic Reviews and Meta-Analyses of
Randomized Controlled Trials (RCTs) At the top of the
evidence hierarchy are systematic reviews and meta-analyses
of RCTs. These studies provide the highest level of evidence
as they rigorously synthesize findings from multiple RCTs on
a particular topic. By pooling data from diverse studies,
systematic reviews and meta-analyses offer robust conclusions
about the efficacy and safety of interventions. They provide
clinicians with evidence-based recommendations that are
derived from the collective results of high-quality research.
Level II Evidence: Individual Randomized Controlled Trials
Individual RCTs represent the gold standard for evaluating the
effectiveness of healthcare interventions. In these studies,
participants are randomly allocated to treatment or control
groups, minimizing bias and allowing for causal inferences to
be drawn. Level II evidence from well-designed RCTs
provides valuable insights into the efficacy, safety, and
tolerability of interventions. Clinicians can rely on findings
from individual RCTs to inform their clinical decisions,
particularly when supported by multiple studies or systematic
reviews.
Level III Evidence: Well-Designed Controlled Trials Without
Randomization, Cohort Studies, or Case-Control Studies
Level III evidence encompasses various study designs,
including well-designed controlled trials without
randomization, cohort studies, and case-control studies. While
these study designs may lack the randomization present in
RCTs, they still provide valuable insights into the associations
between exposures and outcomes. Cohort studies follow a
group of individuals over time to assess the incidence of
outcomes, while case-control studies compare individuals with
a particular outcome (cases) to those without the outcome
(controls). Although Level III evidence is considered weaker
than RCTs, it can still contribute valuable information to
clinical decision-making, especially when RCT data are
limited or unavailable.
Level IV Evidence: Case Series, Case Reports, and
Historically Controlled Studies At Level IV, we find case
series, case reports, and historically controlled studies. These
study designs are characterized by their observational nature
and lack of control groups. Case series and case reports
describe the experiences of individual patients or small groups
of patients with a particular condition or intervention. While
these studies may provide anecdotal evidence or generate
hypotheses, they are limited in their ability to establish
causality or generalizability. Historically controlled studies
compare outcomes before and after an intervention but are
prone to biases such as confounding and secular trends.
Level V Evidence: Expert Opinion and Descriptive Studies
Level V evidence includes expert opinion and descriptive
Uva Clinical | Understanding Evidence Levels in Evidence-Based Medicine: A Guide for Healthcare Professionals
studies, such as narrative reviews, expert commentaries, and
qualitative studies. While expert opinion can offer valuable
insights based on clinical experience and expertise, it is
subjective and may vary among individuals. Descriptive
studies provide a qualitative understanding of phenomena but
lack the rigor of analytical studies. While Level V evidence
may inform clinical practice in the absence of higher-level
evidence, it should be interpreted cautiously and supplemented
with stronger evidence whenever possible.
Conclusion: Evidence levels in EBM serve as a hierarchical
framework for evaluating the quality and strength of research
evidence. By understanding the hierarchy of evidence,
healthcare professionals can critically appraise research
findings, make evidence-based decisions, and deliver optimal
care to patients. While Level I evidence from systematic
reviews and meta-analyses of RCTs represents the pinnacle of
evidence hierarchy, clinicians must consider evidence from all
levels in the context of patient preferences and clinical
expertise. By integrating the best available evidence with
clinical judgment and patient values, healthcare professionals
can uphold the principles of evidence-based medicine and
strive for excellence in patient care.
Levels of evidence provide a systematic way to assess the
quality and strength of scientific evidence supporting a
particular intervention, treatment, or practice. These levels are
commonly used in evidence-based medicine to guide clinical
decision-making. Here are the typical levels of evidence,
ranked from strongest to weakest:
Level I: Evidence from systematic reviews or meta-analyses
of randomized controlled trials (RCTs).
Level II: Evidence from at least one properly designed
randomized controlled trial.
Level III: Evidence from well-designed controlled trials
without randomization, cohort or case-control analytical
studies, multiple time-series designs, or dramatic results from
uncontrolled experiments.
Level IV: Evidence from well-designed case series, case-
control studies, or historically controlled studies.
Level V: Evidence from expert opinion or descriptive studies,
such as case reports or expert committees.
Higher levels of evidence, such as Level I and Level II,
generally carry more weight in guiding clinical practice
decisions because they are based on rigorous study designs
with minimized bias. Lower levels of evidence, such as Level
III, IV, and V, provide increasingly weaker support for clinical
recommendations and may be subject to more uncertainty and
potential bias.
History of Evidence Base:
The concept of levels of evidence traces back to the late 1970s
when the Canadian Task Force on the Periodic Health
Examination sought to develop evidence-based
recommendations for periodic health exams. Their goal was to
establish a systematic approach for evaluating the
2
effectiveness of various interventions by considering evidence diagnosis, or economic/decision analysis. Recognizing this
from the medical literature. To achieve this, they devised a diversity, it became apparent that the type and level of
system of rating evidence, which formed the basis for grading evidence required for each category of question needed to be
recommendations. tailored accordingly.

In 1979, the Task Force introduced a system of rating For instance, the American Society of Plastic Surgeons
evidence, which classified evidence into different grades based (ASPS) developed levels of evidence specifically tailored for
on its quality and reliability. For instance, Grade A prognosis. This adaptation acknowledges that questions
recommendations were assigned when there was robust related to prognosis, which inquire about the natural course of
evidence supporting the inclusion of a particular condition in a disease or condition without interventions, require different
the periodic health exam. This early framework laid the types of studies compared to questions about treatment
groundwork for the subsequent development of levels of efficacy. In prognosis research, the emphasis is on
evidence. understanding what will happen if no intervention is
undertaken. Consequently, cohort studies or systematic
Further refinement and expansion of the levels of evidence reviews of cohort studies are considered the highest level of
were undertaken by David Sackett, a pioneer in evidence- evidence for prognosis questions, as they provide valuable
based medicine, in his work on antithrombotic agents in 1989. insights into the natural history of a condition.
Sackett's contribution expanded upon the initial framework
established by the Canadian Task Force, providing more In contrast, the Centre for Evidence-Based Medicine (CEBM)
detailed criteria for assessing the quality of evidence. has developed levels of evidence focused on treatment
questions. This classification system acknowledges that
Both systems, as described by the Canadian Task Force and randomized controlled trials (RCTs) are often the gold
Sackett, positioned randomized controlled trials (RCTs) at the standard for assessing treatment efficacy. However, it also
apex of the evidence hierarchy. RCTs were deemed to offer the recognizes that not all RCTs are created equal, and poorly
highest level of evidence due to their rigorous design, which designed RCTs may not offer robust evidence. As a result, the
minimizes bias and systematic errors. By randomly assigning CEBM classification system accounts for the quality of data
participants to different treatment groups, RCTs effectively when assigning levels of evidence. For example, poorly
control for confounding variables that could otherwise distort designed RCTs are grouped together with cohort studies,
results. reflecting their comparable levels of evidence.
Conversely, case series and expert opinions were relegated to Table 1: Grades of Recommendation
the lowest levels of evidence. These forms of evidence are
susceptible to bias, often influenced by the subjective Grade of
Level of
experiences or opinions of the authors without adequate Recomme Type of Study
Evidence
control of confounding factors. ndation
Systematic review of (homogeneous)
Overall, the levels of evidence framework developed by the A 1a randomized
Canadian Task Force and refined by Sackett provided a controlled trials
structured approach to evaluating evidence, enabling clinicians Individual randomized controlled trials
and researchers to make informed decisions based on the A 1b (with narrow
strength and reliability of available evidence. This framework confidence intervals)
continues to be a cornerstone of evidence-based medicine, Systematic review of (homogeneous)
guiding medical practice and research methodology B 2a cohort studies
worldwide. of "exposed" and "unexposed" subjects
Individual cohort study / low-quality
Evolution of evidence-based medicine: B 2b randomized
control studies
The evolution of evidence-based medicine has led to the Systematic review of (homogeneous)
recognition that a one-size-fits-all approach to levels of B 3a
case-control studies
evidence may not adequately address the diverse range of B 3b Individual case-control studies
research questions across different medical specialties. Case series, low-quality cohort or case-
C 4
Consequently, various organizations and journals have control studies
developed modifications or variations of the classification Expert opinions based on non-systematic
system to better suit their specific needs and the nature of the D 5 reviews of
questions being asked. results or mechanistic studies

Different specialties often pose distinct types of research

questions, such as those pertaining to treatment, prognosis,

Uva Clinical | Understanding Evidence Levels in Evidence-Based Medicine: A Guide for Healthcare Professionals 3
These modifications to the levels of evidence framework
underscore the importance of tailoring the classification
system to the specific research questions at hand and
considering the quality of the data available. By doing so,
researchers and clinicians can better evaluate the strength and
reliability of evidence, ultimately enhancing the practice of
evidence-based medicine across diverse medical specialties.
Table 2: Levels of Evidence:
Level IX: Evidence from opinion of authorities and/or reports
of expert committee.
Remember: Randomized controlled trials represent a higher
level of evidence than studies where subject selection is not
random.
Controlled studies carry a higher level of evidence than those
without control groups.

Table 3: levels provide a framework for evaluating the

strength of evidence in therapeutic studies:

Level Type of Evidence

1A Systematic review (with homogeneity) of RCTs

1B Individual RCT (with narrow confidence intervals)

1C All or none study

Systematic review (with homogeneity) of cohort

2A studies

Individual Cohort study (including low quality RCT,

Levels of evidence based on the criteria provided:
2B e.g. <80% follow-up)
Filtered evidence:
2C "Outcomes" research; Ecological studies
Level I: Evidence from a systematic review of all relevant
randomized controlled trials. Systematic review (with homogeneity) of case-control
Level II: Evidence from a meta-analysis of all relevant 3A studies
randomized controlled trials.
Level III: Evidence from evidence summaries developed from 3B Individual Case-control study
systematic reviews.
Level IV: Evidence from guidelines developed from Case series (and poor quality cohort and case-control
systematic reviews. 4 study)
Level V: Evidence from meta-syntheses of a group of
descriptive or qualitative studies. Expert opinion without explicit critical appraisal or
Level VI: Evidence from evidence summaries of individual based on physiology bench research or "first
studies. 5 principles"
Level VII: Evidence from one properly designed randomized
controlled trial. These levels provide a framework for evaluating the strength of
Unfiltered evidence: evidence in therapeutic studies, ranging from systematic reviews of
randomized controlled trials (RCTs) at Level 1A to expert opinion at
Level VIII: Evidence from nonrandomized controlled clinical Level 5.
trials, nonrandomized clinical trials, cohort studies, case
series, case reports, and individual qualitative studies.

Uva Clinical | Understanding Evidence Levels in Evidence-Based Medicine: A Guide for Healthcare Professionals 4
Table 4: Strength of recommendations:
Grade Descriptor Qualifying Evidence
Strong Level I evidence or consistent findings from Clinicians should follow a strong recommendation unless a clear
A recommendation multiple studies of levels II, III, or IV
Levels II, III, or IV evidence and findings
B Recommendation are generally consistent
Levels II, III, or IV evidence, but findings
C Option are inconsistent
Level V evidence: little or no systematic
D Option empirical evidence
These grades provide guidance on the strength of recommendations for clinical practice based on the available evidence, ranging from strong
recommendations supported by high-quality evidence to options based on limited or inconsistent evidence.
Strength of Recommendation Taxonomy (SORT):
The Strength of Recommendation Taxonomy (SORT) used by
the American Academy of Family Physicians categorizes
recommendations based on the quality and consistency of
available evidence. Here's how it works:
A: Recommendation based on consistent and good-quality
patient-oriented evidence: This includes evidence from well-
conducted randomized controlled trials (RCTs), meta-
analyses, or systematic reviews of RCTs.
B: Recommendation based on inconsistent or limited-
quality patient-oriented evidence: This category involves
evidence from observational studies, unsystematic clinical
experience, or randomized controlled trials with some
limitations.
C: Recommendation based on consensus, usual practice,
opinion, disease-oriented evidence, or case series for
studies of diagnosis, treatment, prevention, or screening:
This category includes evidence from expert opinion, clinical
experience, or reports of expert committees.
SORT grades help clinicians evaluate the strength of
recommendations in clinical review articles and make
informed decisions about patient care.
Interpretation of levels:
Understanding the levels of evidence in research is crucial for
accurately interpreting the strength and reliability of scientific
Uva Clinical | Understanding Evidence Levels in Evidence-Based Medicine: A Guide for Healthcare Professionals
Implications for Practice
and compelling rationale for an alternative approach is present
Generally, clinicians should follow a recommendation but should
remain alert to new information and sensitive to patient preferences
Clinicians should be flexible in their decision-making regarding
appropriate practice, although they may set bounds on alternatives;
patient preference should have a substantial influencing role
Clinicians should consider all options in their decision making and
be alert to new published evidence that clarifies the balance of
benefit versus harm; patient preference should have a substantial
influencing role
findings. While assigning a level to research papers helps
readers gauge the quality of evidence, it's essential to
recognize that the designated level doesn't always guarantee
the quality of the research itself. This is particularly pertinent
in fields like Plastic Surgery, where innovation and technique
articles are integral to advancing the specialty, even if they
may have lower levels of evidence.
Randomized Controlled Trials (RCTs) are often considered the
gold standard in evidence hierarchy, typically receiving the
highest level of evidence designation. However, not all RCTs
are conducted equally, and their results should be critically
evaluated. It's important to assess factors such as
randomization, blinding, sample size, withdrawals, confidence
intervals, and power analysis when interpreting RCT findings.
Tools like the Jadad scale can assist in judging the quality of
RCTs, although basic considerations can also be helpful.
For instance, a study by Bhandari et al. evaluated the quality
of surgical RCTs published in the Journal of Bone and Joint
Surgery (JBJS). They found that a significant proportion of
papers scored below the threshold for high quality, primarily
due to issues with randomization, blinding, and patient
exclusion criteria. Interestingly, another study observed
similar quality scores for level 1 and level 2 studies,
challenging the assumption that level 1 studies inherently have
superior quality.
Surgeons can refer to user guides published in journals like the
Canadian Journal of Surgery and the Journal of Bone and Joint
Surgery for assistance in appraising levels of evidence. These
5
guides provide valuable frameworks for evaluating research
quality and understanding the implications of different levels
of evidence. Additionally, resources like publications in the
Journal of the American Medical Association offer broader
insights applicable across medical disciplines, aiding surgeons
in making informed decisions based on the available evidence.
Conclusion:
In conclusion, understanding the levels of evidence in
evidence-based medicine is essential for healthcare
practitioners striving to provide high-quality patient care. By
recognizing the hierarchy of evidence, clinicians can critically
evaluate research findings and apply the most robust evidence
to clinical decision-making.
Systematic reviews and meta-analyses of randomized
controlled trials (Level I evidence) provide the strongest
evidence for clinical interventions, offering insights into
treatment efficacy and safety. As evidence moves down the
hierarchy to lower levels, such as observational studies and
expert opinions, the reliability and applicability of findings
may diminish. However, lower-level evidence still holds value
in certain contexts, particularly when higher-level evidence is
lacking or when considering patient preferences and clinical
expertise.
Clinicians should approach evidence appraisal with a critical
mindset, considering factors such as study design, sample size,
bias, and clinical relevance. Additionally, integrating patient
values and preferences into the decision-making process is
essential for patient-centered care.
By mastering the principles of evidence-based medicine and
applying them judiciously in clinical practice, healthcare
professionals can enhance patient outcomes, improve
healthcare quality, and contribute to the advancement of
medical knowledge.
Authors’ Contributions:
The manuscript's conception and writing were undertaken by
I.K. Contributions to the manuscript's revisions were made by
other co-authors. All authors participated in the article's
creation, provided substantial input during the revision
process, and approved the final submitted version.
Declaration of Interest:
No conflicts of interest were declared by the authors.
Questions:
1. What are the different levels of evidence in evidence-
based medicine, and how are they categorized?
2. Why is it important for healthcare practitioners to
understand the hierarchy of evidence?
Uva Clinical | Understanding Evidence Levels in Evidence-Based Medicine: A Guide for Healthcare Professionals
3. Can you provide examples of Level I evidence and
explain why it is considered the strongest form of
evidence?
4. How do lower levels of evidence, such as expert opinions
and case reports, contribute to clinical decision-making?
5. What factors should clinicians consider when appraising
evidence from clinical studies?
6. How does evidence-based medicine help clinicians make
informed decisions about patient care?
7. In what situations might lower levels of evidence be more
appropriate or applicable than higher levels of evidence?
8. What role do patient values and preferences play in
evidence-based practice?
9. How can healthcare professionals stay updated on the
latest evidence and research findings in their field?
10. Can you provide examples of how evidence-based
medicine has positively impacted patient outcomes or
healthcare practices?
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