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5.41 Identifying the Highest Level of Evidence for Interventional Studies
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121
• Level 1 = High-quality randomized controlled trial with or without statistically
significant differences with narrow confidence intervals
• Level 2 = Lesser quality randomized controlled trial with <80% follow-up, no
blinding, or improper randomization
• Level 3 = Case-control studies, retrospective comparative study, a systematic
review of level 3 studies
• Level 4 = Case study and case series
• Level 5 = Expert opinion based on best available evidence or an expert panel
5.42 Pragmatic Versus Prescriptively Applied Interventions
• Pragmatic-Treat the patients like you do in clinical practice with the same chal-
lenges and demands as clinical practice (meaning the intervention is tailored to
the individual patient)
• Prescriptive-Carefully controls everything and makes sure the effect reflects a
standardized intervention that is the same for each patient
Questions at Should Be Asked When Reading an Article About an Interven-
5.43
tion
121
• Did the study use the CONSORT or some other reporting guideline?
• Was the trial prospectively registered, and are the reported findings consistent
with the prospective intent of the study?
• Was the prognosis the same for the intervention and control groups at the start
of the study?
• Were the patients randomized?
—NOTES—
5.44 Questions at Should Be Asked When Reading an Article About an Interven-
tion (Cont.)
121
• Was the randomization concealed?
• Were the patients in the study groups similar with respect to known prognostic
factors?
• Was the prognosis balance maintained as the study progressed?
• To what extent was the study blinded?
5.45 How can I critically appraise a systematic review with or without a meta-
analysis?
• Systematic reviews vary in their methodological quality and are made up of indi-
vidual articles with varying degrees of external validity, internal validity, and risk
of bias
• A systematic review should be rated as at least “moderate” on the AMSTAR 2
(https://amstar.ca/Amstar-2.php) in order to be sure that the review provides an
accurate summary of the literature
• It has been suggested that approximately 10% of systematic reviews meet this
criterion when using the AMSTAR 2
127
• It has been demonstrated that there is “very low” confidence in the results of
most systematic reviews
127
5.46 What are the questions that should be asked when reading an article about a
treatment system?
• Does the treatment system start with the answer to a question or a hypothesis?
• Can the assessment measures of interest for the treatment system be present in
the asymptomatic population?
• Is the treatment system reliable?
• When applying the treatment system, are there statistically significant, meaning-
ful differences between the asymptomatic and symptomatic populations?
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—NOTES—
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• Do the outcomes that are used to classify the patients in the treatment system
change in proportion to established subjective and objective outcome measures
for the condition of interest with treatment?
5.47 Application of the Evidence while Considering Contextual Factors
• Best available evidence
° Highest level
° Externally valid
° Internally valid
■
Quality
■
Risk of bias
• Context of the conversation
• Clinical experience
• Patient values
• Measure and evaluate the patient’s response
5.48 What is clinical reasoning?
• “Clinical reasoning is a reective process of inquiry and analysis carried out by a
health professional in collaboration with the patient with the aim of understanding the patient, their context, and their clinical problem(s) in order to guide
evidence-based practice.”
128
• e critical component of this definition is that it is a REFLECTIVE PRO-
CESS, that occurs in collaboration with the patient, and it is required to guide
the application of the best available evidence. If a clinician does not understand
what clinical reasoning is and, potentially, more importantly, what it isn’t, they
do not have a critical component that is required for the application of the evidence in EBP
Post-Script
5.49
• e ability to recognize what the scientific method, EBP, and clinical reasoning is
and is not are fundamental components of a disciplined reasoned approach that
seeks to eliminate logically fallacious reasoning and cognitive biases in the best
interest of the patient
• Ultimately, this approach is theoretical. As a theoretical approach, it stands on
the same ground as other untested and unproven clinical reasoning approaches
129-132
and tools
• Although the present approach has sought to include the concepts of reasoning
and eliminate the reasoning challenges related to the use of other tools, it does
not mean that this approach is the only, right, or best solution to the problem
5.50 Post-Script (Cont.)
• e utilization of this theoretical model should improve academic performance,
clinical performance, and patient outcomes
• is theoretical approach therefore needs to be tested and survive the process of
falsification
• is theoretical proposition is testable and falsifiable through Markov chain and
Bayesian statistical methods that are used to create artificial intelligence
5.51 “We are trying to prove ourselves wrong as quickly as possible, because only in
that way can we find progress.”- Richard P. Feynman
• e purpose of this slide is for the reader to reflect on the content of this pre-
sentation and how the material may apply as clinicians integrate and apply the
concepts of clinical reasoning, EBP, and the scientific method
42
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6.1 Review Questions & Case Scenarios
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• Section 6
6.2
What do evidence-based practice and clinical reasoning have in common?
a. ey start by formulating an answer or best treatment approach, testing the po-
tential solution to the question or treatment method, and analyzing the patient’s
response.
b. ey start by looking for evidence that supports a treatment approach, testing
the treatment approach, and analyzing the patient’s response.
c. ey start by formulating a question or hypothesis, testing the potential ques-
tion or hypothesis, and analyzing the patient’s response.
d. ere are no similarities between these three processes. Each process has its own
unique attributes and purpose.
e best response is c. ey start by formulating a question or hypothe-
sis, testing the potential question or hypothesis, and analyzing the patient's response. Both processes start with formulating a question or a hy-
pothesis, testing the question or the hypothesis, and analyzing the patient’s
response.
6.3 Case Scenario 1
• You are having a professional conversation with a colleague who is touting a
treatment intervention. e colleague reports that he has done a search on the
PEDro website and found that there were systematic reviews that determined
that the treatment intervention was effective for individuals with neurological
impairments and that it was “moderately effective” for a variety of musculoskeletal conditions. ey also report that a study for knee osteoarthritis had a PEDro
score of 7/10.
—NOTES—
6.4
Is your colleague bringing forth an EBP based discussion?
a. Yes. e use of the PEDro website provides moderate to high-quality evidence
that treatment interventions are safe and effective.
b. No. ere is no evidence that your colleague included all of the relevant studies
from the PEDro website to the discussion (Confirmation bias).
c. Yes. e use of systematic reviews from the PEDro website that are “moderately
effective” represents the highest level of evidence.
d. No. e PEDro scores for the systematic reviews were not discussed.
e best response to the question is b. No. ere is no evidence that your col-
league included all of the relevant studies from the PEDro website to the discussion (Confirmation bias). Based on the information that was obtained during
the conversation, there is no way of knowing if the clinician started with a clinically
meaningful question and followed the process of EBP. Based on the context of the
conversation, that clinician most likely began with the answer to a question and
only sought evidence that supported that answer and disregarded the evidence that
didn’t.
6.5 You look up the studies on the intervention that your colleague has been
touting on the PEDro website. You discover that half of the studies that your
colleague cited did not meet criterion one on the PEDro score, and for the
other studies, the PEDro score is below 6. While on the PEDro website, you
discover 5 different studies that satisfy the external validity criterion and have
PEDro scores of 6 or higher. e next day, you bring in the evidence to have
a conversation with your colleague. You report on what you found, and your
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—NOTES—
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colleague responds with, “you didn’t find any evidence that this assessment
and treatment approach doesn’t work.” He elaborates on his recognition as a
clinical expert and that the best clinics and research institutions in the country
are using this treatment system.
6.6
Is your colleague bringing forth a well-reasoned EBP informed discussion?
a. No. Your colleague appears to be guilty of recall bias, and a fallacy of incomplete
evidence to support his decision.
b. Yes. If master clinicians and high-level researchers from all over the country are
using this technique, they have likely critically appraised the literature. ey are
combining evidence with patient values and their expert clinical experience.
c. Yes. e absence of evidence is not evidence of absence. Only an expert clinician
can make this determination.
d. No. Your colleague appears to be using confirmation bias, an appeal to igno-
rance logical fallacy, and an appeal to authority logical fallacy.
e best choice is d. No. Your colleague appears to be using confirmation bias,
an appeal to ignorance logical fallacy, and an appeal to authority logical fallacy. Your colleague appears only to be interested in evidence that supports his/her
opinion, and he/she is not interested in identifying the best available evidence and
following the process of EBP. If somebody is claiming that something is true, the
burden is on them to provide high-quality evidence that it is true using a reasoned
approach that is free from logically fallacious thinking and cognitive biases.
6.7 Beyond being a clinical expert, your colleague states that he has seen the intervention work within 6-8 weeks with his own eyes and that this type of pragmatic clinical experience provides the best evidence.
6.8 Is your colleague bringing forth a well-reasoned EBP informed discussion?
a. No. Your colleague is using cum hoc ergo propter hoc and/or post hoc ergo
propter hoc logical fallacies without consideration of the best available evidence
and the natural progression of most musculoskeletal conditions.
b. Yes. ere is no better proof for a treatment intervention than to see its efficacy
clinically.
c. Yes. EBP is a combination of the best available evidence, clinical experience, and
patient values. In this context, the clinical experience far outweighs the other
pillars of EBP.
d. No. Your colleague appears to be using confirmation bias, an argument from
ignorance logical fallacy, and an appeal to authority logical fallacy.
e best answer is a. No. Your colleague is using cum hoc ergo propter hoc and/
or post hoc ergo propter hoc logical fallacies without consideration of the best
available evidence and the natural progression of most musculoskeletal conditions. ere are several reasons why a patient’s symptoms may improve. One of the
most common reasons is the passage of time and the normal healing response after
an acute injury.
6.9 Case Scenario 2
• You are participating in a journal club conversation for a cohort study that was
conducted by an “expert” team of researchers. You point out to your colleagues
that the sample in this cohort study is made up of 92 males. ere is no rationale
reported in the study that should exclude females. You suggest that this may
be sampling bias and that the sample created for this study significantly limits
the external validity of the study’s findings. Your colleague responds with, “your
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research experience has biased your ability to objectively critically appraise the
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literature.”
6.10 Is your colleague accurate in her arguments regarding the critical appraisal of
this article?
a. No. Your colleague failed to recognize that experience, whether clinical or re-
search provides strong evidence of that observations are accurate.
b. Yes. Individuals with research experience that publish research articles tend to
unfairly attack research studies that do not support their point of view.
c. No. Your colleague has chosen to attack you personally instead of attempting to
directly refute your claims based on facts or a reasoned approach.
d. Yes. Sampling methodology is not an essential component in determining the
generalizability of a research study. According to the PEDro score, the study’s
inclusion and exclusion criteria are the most critical components in determining
external validity.
e best choice is c. No. Your colleague has chosen to attack you personally
instead of attempting to directly refute your claims based on factors or a reasoned approach. is is an ad hominem attack. If you are going to claim that
somebody is biased or that they are not following an EBP reasoned approach, you
should use facts to support your professional opinion.”
6.11 You report to your colleague that the determination of who the study’s findings
apply to is an important thing to consider when critically appraising the literature. If the sample created is not like the patient or patients that the clinician
treats, the findings may not be helpful. Your colleague replies that you are over
biasing the use of the evidence in EBP. at EBP is a combination of the best
available evidence, clinical experience, and patient values. She goes on to report that none of these factors should outweigh any of the others.
—NOTES—
6.12 Is your colleague accurate in her arguments regarding what EBP is?
a. No. EBP involves using these contextual elements of EBP after first asking a
clinically relevant question and identifying the best available evidence that can
be used to answer the question.
b. Yes. Everybody recognizes this as Sackett’s definition of EBP.
c. Yes. ere are many times when the research evidence is inconclusive. Critical
appraisal of the best available literature is, therefore, not as essential as using a
reasoned application of clinical experience and patient values.
d. No. You first must see if there is any evidence to make that conclusion. If there
isn’t any evidence to support the conclusion, then and only then would that
conclusion be appropriate.
e best selection is a. No. EBP involves using these contextual elements of
EBP after first asking a clinically relevant question and identifying the best
available evidence that can be used to answer the question. EBP is a process of
disciplined thinking. Clinicians and researchers should not eliminate components
of the process that may not support their point of view.
6.13 Case Scenario 3
• You have a 32-year-old male patient that complains of left forearm and hand
“discomfort” that started two weeks ago after he completed 6 hours of raking
in his yard. He is left arm dominant. e patient reports that he has specific
lateral elbow pain 6/10 at worst that occurs with gripping and shutting his car
door with his elbow extended. He also complains of a more generalized area of
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45
—NOTES—
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symptom from the medial elbow to the fourth and fifth fingers. He reports that
he had similar symptoms when he was a baseball pitcher in college.
6.14
What would your primary hypothesis be for the mechanism, location, and
load for this patient?
a. Mechanism = nociceptive, Location = lateral elbow, and load = compression at
the lateral elbow.
b. Mechanism = referred, Location = medial elbow, and load = tension at the me-
dial elbow.
c. Mechanism = radicular, Location = lateral elbow, and load = compression at the
cervical spine.
d. Mechanism = nociplastic, Location = lateral elbow, and load = does not apply.
e best choice is a. Mechanism = nociceptive, Location = lateral elbow, and
load = compression at the lateral elbow. e patient reports:
• e primary symptomatic complaint is at the lateral elbow with gripping activi-
ties.
• e symptoms also increase with closing the car door through valgus stress at the
elbow, which would explain lateral pain with medial ulnar symptoms secondary
to a potentially incompetent ulnar collateral ligament.
• He had similar symptoms in the past with pitching in college, suggesting valgus
stress overload causing primary lateral humeroradial compression and secondary
ulnar nerve tension.
6.15 If your primary hypothesis is correct, what mechanical input should make the
patient’s symptoms better and worse?
a. e patient’s primary symptomatic complaint should be better with gripping
with valgus stress at the elbow and worse with varus stress at the elbow.
b. e patient’s primary symptomatic complaint should be better with gripping
with the elbow straight and worse with the elbow bent.
c. e patient’s primary symptomatic complaint should be worse with gripping
with valgus stress at the elbow and better with varus stress at the elbow.
d. e patient’s primary symptomatic complaint should be better with gripping
with the forearm pronated and worse with the forearm supinated.
e best selection is c. e patient's primary symptomatic complaint should
be worse with gripping with valgus stress at the elbow and better with varus
stress at the elbow. If the patient’s primary symptomatic complaint is related to
radiohumeral compression, valgus stress should increase lateral compression at the
elbow, and varus stress should decrease compression at that joint.
6.16
Case Scenario 4 - You are treating a patient that you suspect has cervical ra-
diculopathy. You decide to consult the literature on the properties of different
special tests for cervical radiculopathy. You find the below results.
133
Special Test Sensitivity Specificity
Spurling’s test 30% 94%
Neurodynamic testing of
the median nerve
72-83% 11-33%
Cervical distraction test 44% 90-97%
Shoulder abduction sign 17-78% 75-92%
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6.17 You decide to rule out cervical radiculopathy as a potential contributing factor
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to the patient’s primary symptomatic complaint. What testing would you use?
a. Cervical active ROM, myotomes, dermatomes, deep tendon reflexes, and Spurl-
ing’s test.
b. Cervical active ROM, myotomes, dermatomes, deep tendon reflexes, and neu-
rodynamic testing of the median nerve.
c. Cervical active ROM, myotomes, dermatomes, deep tendon reflexes, and the
cervical distraction test.
d. Cervical active ROM, myotomes, dermatomes, deep tendon reflexes, and the
Shoulder Abduction Sign.
e best response is b. Cervical active ROM, myotomes, dermatomes, deep ten-
don reflexes, and neurodynamic testing of the median nerve. e Spurling’s
and Distraction tests are specific tests and appropriately used to rule the condition
in. Neurodynamic testing is sensitive and useful in ruling the condition out. e
shoulder abduction sign has questionable clinical utility.
Which of the following causes of errors in clinical reasoning can you improve
6.18
through EBP?
a. Faulty metacognition.
b. e inability to recognize logically fallacious thinking and cognitive biases.
c. Clinical experience.
d. Inadequate knowledge.
—NOTES—
e answer is d. Inadequate knowledge. e purpose of EBP is to have the cli-
nician improve their knowledge related to the best available evidence related to
the cause of symptoms, diagnosis, prognosis, or intervention for a specific patient
population.
Appendix 1. Questions at May be Used to Improve the Metacognitive Process
Questions to improve clarity,
accuracy, precision, relevance, and depth of knowl-
Considerations of whether the reasoning adequately addresses the underlying
complexity of the issue
edge
100
For example:
• Could you put that another way?
• How could we verify that?
• Could you be more specific?
• How does that relate to the main issue?
Questions to improve the
breadth of knowledge
Considerations of whether there is a need
for another point of view
For example:
• Have you thought about any other ways to interpret
the situation?
Questions to determine the
most pragmatic approach for
the patient
Questions to determine if
conclusions are fair
Are used to determine the most important things to focus on
Self-reflection on the potential bias,
assumptions, or vested interests that may
be unconsciously influencing reasoning
For example:
• If you could only address one item, which one would
have the most impact? Why? How?
For example:
• Are there any conclusions you may have jumped to that
you have not yet validated?
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Appendix 2. Five Micro Skills Model for Mentorship to
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Improve Clinical Reasoning
105
1. Obtain a commitment from the learner about what he or
she thinks is happening with the patient’s problem first
(instead of a summary of the case so that the mentor can
solve the problem)
2. Probe for underlying reasoning (eg, consider all relevant
reasoning strategies)
3. Teach/review general concepts, principles, and specific
knowledge related to understanding the case (if needed or
if gaps in knowledge have been revealed that are critical to
caring for the patient at that juncture)
4. Provide positive feedback about what the learner has done
well
5. Correct errors (as needed in the moment, for the benefit
of the patient)
7.1 References
• Section 7
Appendix 3. User Guide for Prognostic Studies
116
• Are the results valid?
• Was the participant sample a smaller representation of the
population of interest?
• Were the participants homogeneous with respect to their
prognostic risk?
• Was the follow-up sufficiently completed?
• Were outcome criteria objective and unbiased?
• What are the results?
• How likely are the outcomes over time?
• How precise are the estimates of likelihood?
• How do the results apply to my patient?
• Were the study participants and their management like the
patients I see in practice?
• Was the follow-up long enough?
• Can I use the results to manage patients in my practice?
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