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4.49 Model for a Clinically Reasoned Approach to EBP
4.49 Model for a Clinically Reasoned Approach to EBP
https://t.me/med1917
111
—NOTES—
Identify the highest level of evidence
Generate a
meaningful
question
Generate a
meaningful
hypothesis
Measure and
evaluate the
Apply the
evidence
Test the
response
through inductive, deductive, and Bayesian reasoning
hypothesis
Modify hypothesis during the physical exam
Critically appraise the evidence
Contextual
Elements
Patient
Values
Best Available
Evidence
Clinical
Experience
Context of the
Conversation
• e scientifi c method, EBP, and clinical reasoning are not mutually exclusive
constructs. ey are all processes that are used to answer clinically meaningful
questions. What makes these processes similar are:
° ey start by formulating a clinical question and/or hypotheses
° ey go on to establish a disciplined process that sets the rules to the game
before playing the game
° ey play the game based on the established rules and attain a result
° ey interpret the result based on the previously established rules
° ey do not attempt to change the rules of the game if they do not like the
result
° ese processes require metacognition related to what is and is not going well
(refl ection in action) during the game and what did and did not go well (refl ec-
tion on action) after the game is played
5.1 Using the Literature in a Reasoned Approach to Evidence-based Practice
• Section 5
5.2 What is the problem related to?
• Is it related to:
Cause
°
Diagnosis
°
Prognosis
°
Intervention
°
5.3 Which questions should be answered fi rst?
• Most important to the patient?
• Most important to the patient’s well-being?
• Most likely to make them feel better?
• Most likely to make them more functional?
5.4 Creating a Specifi c, Answerable, Clinical Question
• What information do you need to answer the question?
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112

—NOTES—
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• Where can I find the information?
• What is the best way to create a search strategy to find the information?
• How can I quickly remove articles that are not relevant to the question?
Clinical Questions Should be Formulated Using PICO
5.5
• P-e Patient or Problem
• I-e “Intervention” or task (cause, diagnostic test, prognosis, treatment)
• C-Comparison intervention/task
• O-Outcome(s)
5.6
What sources potentially help identify the highest level of evidence?
• Expert opinion
• Textbooks
• Peer-reviewed literature
• Summary/Preprocessed sources
• Original papers
5.7
Tracking Down the Evidence
• Usefulness index-Is the internal validity of the research multiplied by the external
validity of the research divided by the amount of time and effort it took to find
113
the literature?
• To improve the usefulness of research for practicing clinicians, it is essential to
increase the quality of the literature and make it easier to find
5.8 Where can you find high-quality resources?
• Evidence-Based Practice Resources-
https://www.apta.org/patient-care/evidence-based-practice-resources
° Is a collection of evidence-based research tools that are available to members of
the American Physical erapy Association (APTA)
° Clinical Practice Guidelines (CPGs)-
https://www.apta.org/patient-care/evidence-based-practice-resources/cpgs
■
Clinical practice guidelines (CPGs) are systematically developed statements
to guide clinicians in using the best available evidence in patient care. PTNow has links to a collection of CPGs for the physical therapy profession
° Tests & Measures- https://www.apta.org/patient-care/evidence-based-
practice-resources/test-measures
■
APTA has secured permission for members to download copies of the tests/
tools/instruments for patient examination in the practice setting. e licensing agreements do not permit APTA to grant permission for other purposes
or third-party use
° Clinical Summaries- https://www.apta.org/patient-care/evidence-
based-practice-resources/clinical-summaries
■
APTA Clinical Summaries synthesize evidence on managing specific condi-
tions in different populations. You also can download condensed Portable
Summaries
° Rehabilitation Reference Center- https://www.apta.org/patient-
care/evidence-based-practice-resources/rehabilitation-reference-center
■
e APTA Rehabilitation Reference Center (RRC) provides current infor-
mation and point-of-care resources in the fields of physical therapy, sports
medicine, occupational, and speech therapy. It is designed to help clinicians
provide the best plan of care for their patients. Content is updated daily and
focuses on systematic identification, evaluation, and consolidation of practice-changing information
• PEDro- http://www.pedro.fhs.usyd.edu.au/index.html
32
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° PEDro is a free Physiotherapy Evidence Database of randomized trials, system-
https://t.me/med1917
atic reviews, and clinical practice guidelines in physiotherapy. PEDro provides
the citation details, the abstract, and a link to the full text, where possible. All
clinical trials on PEDro are assessed for quality by individuals trained on the
use of the PEDro scale
° e PEDro scale has 11 criteria. e first criteria is related to the presence of
inclusion and exclusion criteria in the study to determine the study’s external
validity. Criteria 2 through 11 are used to determine the internal validity of the
study. According to the PEDro website a PEDro score of 6 or greater for criteria 2-11 is required to determine if the study has a respectable level of internal
validity.
• DiTA- https://dita.org.au/
° DiTA is the Diagnostic Test Accuracy database that indexes systematic reviews
and primary diagnostic accuracy studies of clinical tests used to make a pathoanatomic diagnosis. DiTA allows the clinician to search for this literature using
a number of different parameters and provides citation details, abstracts, and
links to full-text to the diagnostic accuracy literature
5.9
Finding Physical erapy Literature
• APTA Article Search- https://www.apta.org/patient-care/evidence-based-
practice-resources/article-search
° ArticleSearch provides APTA members with easy access to journals and other
resources relevant to clinical practice, including full-text access to research and
articles from more than 4500 clinical and academic publications
• PubMed/MEDLINE- https://www.ncbi.nlm.nih.gov/pubmed/
° PubMed is the National Library of Medicine’s (NLM) free electronic database
of 20 million biomedical citations and abstracts. It covers the fields of medicine, nursing, and health and rehabilitation sciences, including physical therapy. Journal articles are indexed, and their citations are searchable. A tutorial on
how to use the PubMed search features can be found at https://www.nlm.nih.
gov/bsd/disted/pubmedtutorial/cover.html
• PubMed Central- https://www.ncbi.nlm.nih.gov/pmc/
° PubMed Central (PMC) is the US National Institutes of Health (NIH) free
digital archive of biomedical and life sciences journal literature. All the articles
and journals posted in PMC are free. PMC also has the free author manuscripts of articles published by NIH-funded researchers
• MedlinePlus- https://medlineplus.gov/
° e National Library of Medicine’s MedlinePlus service includes links to addi-
tional sources of health-related information such as news articles, directories,
organizations, databases, and medical dictionaries
• CINAHL- https://www.ebscohost.com/nursing/products/cinahl-databases
° CINAHL is the electronic version of the Cumulative Index of Nursing and
Allied Health Literature. APTA members have access to CINAHL through ArticleSearch. CINAHL covers 1961 to the present and includes citations from
3000+ journals and related magazines, including Physical erapy (PTJ) and
PT in Motion
• OVID- https://www.ovid.com/
° OVID is a search engine that is used to find relevant medical research for pa-
tient care. Although there is an expense to using this database, some clinicians
may have access to it through their employer or local library. A tutorial on
how to use the OVID search features can be found at https://www.ovid.com/
support-training/product-training/online-training.html
• Cochrane Library https://www.cochranelibrary.com/
—NOTES—
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—NOTES—
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° e Cochrane Library helps providers, practitioners, and patients make in-
formed decisions about health care
5.10
Research Designs and Statistics for Different Clinical Questions
• If you have a specific clinical question that you would like to answer, beyond the
creation of a PICO question and finding the literature, it is essential to identify
the highest level of evidence and best design to answer the question, before critically appraising the study for its quality and risk of bias
• A breakdown in the ability to identify and critically appraise the best available lit-
erature prevents the clinician from being able to accurately complete the process
of EBP and breaks the deductive link between EBP and its application through
the clinical reasoning process
• e following slides do not contain information that needs to be memorized.
is information should be used as a tool to help you answer your clinical questions by identifying the best available literature to answer the question
Prognosis: What is the natural history of LBP?
5.11
114
• Optimal Research Design: Inception cohort
• Examples of Common Statistical Representations: Survival curves
• Limitations: Difficult to account for the effect of variations in “standard of care”
during the condition
5.12 Prognosis: What factors influence my patient’s outcomes?
114
• Optimal Research Design: Inception cohort
• Examples of Common Statistical Representations: Odds ratios/Likelihood ratios
• Limitations: Difficult to account for all the factors that influence outcome (as-
sembly bias)
5.13 Diagnosis: What screening tools are best to detect the presence or absence of a
condition?
114
• Optimal Research Design: Cross-sectional with comparison to “gold standard”
• Examples of Common Statistical Representations:
° Reliability of the test (kappa)
° Positive and negative specific agreement
° Sensitivity
° Specificity
° Likelihood ratios
• Limitations: Relies upon the validity of the gold standard; interpretation is great-
ly affected by the prevalence of the condition
5.14 What treatment is best for my patient?
114
• Optimal Research Design:
° Low quality: case-series or group comparisons without random assignment
° High quality: randomized clinical trials
° High quality: systematic reviews and meta-analyses
• Examples of Common Statistical Representations:
° Low quality: Pre- to post-change scores or group comparisons (p-value, effect
size difference)
° High quality: randomized clinical trials
■
Pre- to post-change scores or group comparisons (p-value, effect size differ-
ence, the number needed to treat)
° High quality: systematic reviews and meta-analyses
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■ Appraisal and summary of the best available literature
https://t.me/med1917
• Limitations:
° Low quality: Lack of random assignment to a comparison (control) group
prevents conclusions regarding the actual effect of the treatment
° High quality: randomized clinical trials
■
May be prone to statistical error due to small sample
° High quality: systematic reviews and meta-analyses
■
Between-study heterogeneity in sample and methods must be addressed
—NOTES—
5.15 What outcome measure is most useful for a given patient?
114
• Optimal Research Design: Longitudinal, case-series
• Examples of Common Statistical Representations:
° Reliability (intraclass correlation, Cronbach alpha, standard error of measure-
ment)
° Minimal detectable change (MDC)
° Minimal clinically important difference (MCID)
° Change score
• Limitations: Determining the minimal important change relies upon some out-
side reference, such as the global rating of change, that may be influenced by
recall bias
Is the study valid?
5.16
• To determine if your patient is like the sample that was created for a study it is
crucial to accurately perform and report the patient’s history, systems review, and
the specific tests and measures performed during the examination and evaluation
process
• Internal validity-is an assessment of the quality of the study design to prevent
115
systematic errors or bias
• External validity-are the results of the study generalizable to your patient?
116
° Did the authors create a non-randomized relationship during the sampling
process by only screening the individuals that they thought would meet the
studies criteria instead of consecutively screening all patients that presented
with the diagnosis of interest?
9
° Does the sample of patients created from the population of interest look like
your patient (age, sex, ethnicity, etc)?
° Would your patient fit the inclusion and exclusion criteria for the study?
• Risk of bias-outside biases related to a study design can also occur through re-
115
searcher conduct, data analysis, and reporting of the study
° Is there any evidence of conscious or non-conscious post-randomization bias?
117
■ For example, did the researcher(s) modify the ‘primary’ and ‘secondary’
outcomes labels between protocol, trial registry, and publication, and fail to
report measures of variation for non-significant outcomes?
117
5.17 If so, does it apply to the patient or patients that you treat?
• Is the study’s research question like the clinical question that you are trying to
answer?
• Is the sample that was created (inclusion and exclusion criteria) like the patient
or patients that you treat?
• Did you perform and document the physical examination in sufficient detail to
allow you to match your variables of interest with the study’s variables of interest?
• Is the study reported in sufficient detail to match your variables of interest with
the study’s variables of interest?
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—NOTES—
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5.18 Reporting Guidelines for Studies
• Reporting guidelines are used to ensure that a study is reported in sufficient detail
to allow for critical appraisal and to ensure that the trial is reproducible in the
future
• ere are different reporting guidelines for different types of studies
• e Equator Network (https://www.equator-network.org/) is a website dedicat-
ed to reporting guidelines for the different major types of studies
• A research study that reports having used a reporting guideline is more likely to
be published with sufficient detail to help you answer your clinical question
5.19 Diagnostic Literature
• Determining the quality of diagnostic literature is based on the pathoanatomic
model and compares a clinical test to a pathoanatomic reference (gold) standard
such as radiographs, MRI, or arthroscopy
• Compares a reference standard to clinical test in a specific population
• Routine referral for diagnostic imaging in patients with knee and LBP provides
little to no benefit for the patient
118
• Additionally, LBP imaging has been shown to be related to higher medical costs,
increased health care utilization, and increased absence from work
hinder recovery
120
119
and may
• e commonly used reporting guideline is the STARD (https://www.equa-
tor-network.org/reporting-guidelines/stard/
)
5.20 Levels of Evidence for Diagnostic Studies
121
• Level 1 = Testing of previously developed diagnostic criteria in a series of consec-
utive patients with a universally applied reference gold standard
° A systematic review of level 1 studies
• Level 2 = Development of diagnostic criteria based on consecutive patients with
a universally applied reference gold standard
° A systematic review of level 2 studies
• Level 3 = Study on non-consecutive patients without a consistently applied ref-
erence gold standard
° A systematic review of level 3 studies
° Case-control study with a poor reference standard
° Expert opinion based on the best available evidence and/or expert panel con-
sensus
Sensitivity
5.21
122
• SnNout illustrates the clinical utility of sensitivity. SnNout means that a test with
high sensitivity (Sn) that is negative (N), helps to rule out something (out)
• It is essential to understand that a test that is high in sensitivity that is not specific
does not answer a specific, meaningful question during a physical exam when it
is positive
• Sensitivity is an essential characteristic of a screening test
° Rule out serious pathology
° Rule conditions out by region
• Helps the clinician decide early during an exam if they should
° Evaluate and treat,
° Evaluate and refer, or
° Refer
• An example of a screening test with high sensitivity is the Ottawa Ankle Rules
5.22 Specificity
122
• SpPin illustrates the clinical utility of specificity. SpPin tells us that a test with a
high specificity (Sp) that is positive (P) helps to rule something (in)
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• A specific test is most helpful when performed near the end of a clinical examina-
https://t.me/med1917
tion to verify the clinician’s primary hypothesis after completing active, passive,
and resistive range of motion
• is may help to prevent cognitive errors related to verification bias, premature
anchoring, and premature closure
• A specific test that is not sensitive that is found to be negative when performed
at the end of a physical exam suggests that the clinician has missed something
—NOTES—
5.23
Positive and Negative Likelihood Ratios
123
• A likelihood ratio is a test’s ability to modify the pretest probability of a diagnosis
being present or absent to the post-test probability of a diagnosis being present
or absent
• e pretest probability is the probability that an individual has a diagnosis before
the test is carried out. It is based on variables such as the patient’s age, symptoms,
epidemiological data, and clinical experience of the practitioner
• e post-test probability is the probability that an individual with a specific test
result has the diagnosis of interest following the test
• Positive likelihood ratio (LR+)
° Reflects the probability that a person who tests positive DOES have the disor-
der
° e threshold for a moderate or greater shift in the post-test probability that
the participant has the diagnosis occurs through a LR+ ≥ 5
• Negative likelihood ratio (LR-)
° Reflects the probability that a person who tests negative really DOES NOT
have the disorder
° e threshold for a moderate or greater shift in the post-test probability that
the participant does not have the diagnosis occurs through a LR- ≤ 0.20
5.24 Challenges of Diagnostic Accuracy Studies
124
• Pathoanatomic findings are a common finding in the asymptomatic population
and pathoanatomic changes naturally increase with age
• Measures of diagnostic accuracy are viewed through a pathoanatomic perspective
• e primary premise is that pathoanatomy is the “cause” of the participant’s
primary symptomatic complaint
• One of the significant challenges for the pathoanatomic model as the “cause” of
a patient’s symptoms is we know that patients can be symptom-free in the presence of pathoanatomic findings and that they may have symptoms without any
pathoanatomic changes
• e diagnostic accuracy of the clinical test is determined by comparing it to a
pathoanatomic gold standard, such as an MRI or arthroscopy
• Although a thorough discussion of the determination of diagnostic accuracy
from a pathoanatomic perspective is outside the scope of the monograph, I will
discuss these terms as they relate to the clinical reasoning process
5.25 Common Problems with Diagnostic Studies
• ere may not be a “gold” or “reference standard” for the diagnosis
• Starts with the conrmation bias of assuming that pathoanatomy is the “cause” of
the patient’s symptoms
• Pathoanatomic findings are sensitive where a negative test is useful in ruling out
a pathoanatomic cause of the patient’s primary symptomatic complaint
• Positive pathoanatomic results do not mean that pathoanatomy is the “cause” of
the patient’s primary symptomatic complaint
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5.26 Common Biases in Diagnostic Studies
124
• Sampling bias- only screened participants that were thought to meet inclusion/
exclusion criteria instead of screening all potential participants with the condition
• Verification bias- when not all participants are assessed by the reference standard
in the same fashion
° Can lead to overestimation of accuracy
• Incorporation bias- reference standard is included in the diagnostic test being
studied
° May occur when the examiner is not blinded to the diagnostic test result and
clinical condition of the participants
• Spectrum bias- participants are not representative of the population in which the
test is likely to be used
■
Should also have a spectrum of the disorder (mild to severe)
5.27 Other Potential Pitfalls of Diagnostic Tests
124
• e intended purpose of the test is not clearly defined
• Lack of clarity in the description of the test performed
• Lack of clarity in the description of the test interpretation
• Judged by an examiner who is not blinded to the results of the reference study
5.28 What are the questions that need to be answered when reading a diagnostic
121
study?
• Are the results valid?
° Did the clinician face diagnostic uncertainty?
° Was there an independent blind comparison with a reference standard?
° Did the results influence the decision to perform the reference standard?
° Were the methods for conducting the test described in enough detail to allow
for replication in future studies?
• What are the results?
° Are the test likelihood ratios or the data required to calculate them present?
• How can I apply the results to patient care?
° Will reproducibility and interpretation of the test results be satisfactory in my
setting?
° Are the results applicable to my patient?
° Will the result change my management of the patient?
° Will the patient be better off as a result of the test?
What are some tools that can be used to assess the quality of a diagnostic study?
5.29
• QUADAS-2 is used to evaluate the risk of bias of diagnostic accuracy studies
(http://www.bristol.ac.uk/media-library/sites/quadas/migrated/documents/quadas2.pdf)
• CASP is used to evaluate diagnostic test studies (http://media.wix.com/ugd/
dded87_3815f02af1b34c21b8c3b2b5020024c3.pdf)
• Centre for Evidence-Based Medicine (CEBM) Diagnosis Critical Appraisal
Worksheet https://www.cebm.ox.ac.uk/resources/ebm-tools/critical-appraisaltools
5.30 Prognostic Studies
• Prognosis: is the predicted level of function that the patient will attain within a
specific timeframe
• Helps guide the intensity, duration, and frequency of the intervention, and aids
in justifying the intervention
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• e commonly used reporting guideline is the STROBE (https://www.equa-
https://t.me/med1917
tor-network.org/reporting-guidelines/strobe)
—NOTES—
5.31
Levels of Evidence for Prognostic Studies
121
• Level 1 - High quality prospective study where all patients were enrolled at the
same point in their disease with ≥ 80% follow-up of the enrolled patients
° A systematic review of level 1 studies
• Level 2 -
° Retrospective study
° Untreated controls from a randomized controlled trial
° Lesser quality prospective study where patients were enrolled at different times
during the recovery process or <80% follow-up
° A systematic review of level 2 studies
• Level 3 - Case-control study
• Level 4 - Case series
General Guidelines for Assessing Prognostic Studies
5.32
125,126
5.33 Are the results valid?
• Primary guidelines
° Was there a representative sample of participants?
■
Were the participants homogeneous with respect to their prognostic risk?
• Were participants at a similar point in the course of the disease?
° If subgroups with different prognoses are identified
■
Did researchers provide estimates for all clinically relevant subgroups?
■
Was there an adjustment for important prognostic factors?
• Secondary guidelines
° Was follow-up sufficiently long and complete?
° Were objective and unbiased outcome criteria used?
° What are the results?
■
How likely are the outcomes to occur over time?
■
How precise are the estimates of likelihood?
° Will the results help me in caring for my patient?
■
Were the study participants and their management like your own patient?
■
Are these results useful in assisting you with managing your patient?
Study Design and Statistics for Prognostic Studies
5.34
• Aspects to consider with prognosis
° Qualitative: Which outcomes could happen?
° Quantitative: How likely are they to happen?
° Temporal: Over what time period?
• Study designs examining prognosis
° Case-Control
° Cohort
° Randomized controlled trial-Each arm is a cohort representing a prognostic
factor of treatment and control/placebo intervention
• Type of statistics used to establish prognosis
° Descriptives, rates, proportions, risks for outcomes
° Odds ratios, likelihood ratios when dealing with clinical practice rules
5.35 Assessing the Validity of Prognostic Studies
• Validity related to homogeneity
° Participants should be at a similar point in their disease
° If at the beginning, it is an inception cohort
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° If not, point in time must be consistent
• Participants should be similar in risk
° How to decide? Known factors, clinical experience, and biology of the condi-
tion
° Risk adjustment may be necessary
• Validity related to follow-up
° “5 and 20 rule”
<5% loss probably = little bias
■
>20% loss seriously threatens the validity
■
° Ask “what if?” there are differential adverse outcome rates
• Validity related to outcome
° Target outcomes clearly specified a priori
° Specify the intensity and frequency of monitoring
■
Status of outcome assessors - blinded vs non-blinded
5.36 Assessing the Results of Prognostic Studies
• Result related to outcome over time
° Percentage of survival
■
Ex. 6-month, 1-year survival
■
Median survival
■
Survival curves
• Results related to precision
° Variability of data - 95% confidence intervals
° e variability that is inconsistent over time - short term versus long term
follow-up
• Application
° Are the findings of this study generalizable to the patient that is sitting in front
of me?
5.37
User Guide for Prognostic Studies (Appendix 3)
121
• 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?
5.38 User Guide for Prognostic Studies (Cont.) (Appendix 3)
121
• 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 prac-
tice?
• Was the follow-up long enough?
• Can I use the results to manage patients in my practice?
5.39 Critical Appraisal of Prognostic Studies
124
• Centre for Evidence-Based Medicine (CEBM) Prognosis Critical Appraisal Sheet
(https://www.cebm.net/wp-content/uploads/2018/11/Prognosis.pdf)
5.40 erapeutic Studies Investigating the Results of an Intervention
121
40
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