1. Research Alternatives for Clinical
Practice
Mary P. Watkins, DPT, MS
Faculty Emerita
MGH Institute of Health Professions
Boston, Massachusetts
1 MP Watkins, 2008

2. Course Objective And Goals
 To define and explore methods for integrating
research activities and clinical practice for the purpose
of achieving effective, timely patient or client care.
 To assure that our clinical intervention strategies
– Are based on the best available research- based
evidence
0R
– Are lacking in that evidence therefore requiring
studies to determine effectiveness – the beginnings
of establishing sound evidence
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3. Identify The Question
 Define the problem
 Identify the variables ?
Characteristics that can be
manipulated (intervention)or
observed (measurement of outcome)
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4. What about all that information
that already exists?
How can we access it?
What can we learn from it?
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5. Evidence Based Practice
The PICO Model
The Search for
Evidence
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6. Introduction :
 Definition of the PICO Model
 A case example
 Asking the question
 Planning the Search
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7. What does PICO represent:
 P – The patient or the disease process
 I – The intervention
– Diagnostic test
– Intervention
 C – A comparison of interventions
 O – The outcome
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8. An example: Read this carefully:
Mrs. C.T. aged 45 years old administrative
assistant who complains of pain and tingling in her
right hand, often waking her up during the night.
The pain bothers her if she works at the computer
for more than 20 minutes without a break. Her
husband is unemployed at this time. She has
accumulated two weeks of sick time. She has had
the appropriate diagnostic tests revealing that she
has carpal tunnel syndrome. Given her present
symptoms, her need to work and the sick time
limit that she has, we need to consider the
treatment approach.
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9. The Patient
 45 years old
 Employed and needs to be
 Symptoms bother her at night and on the job
 She has 2 weeks of sick time
 On questioning, her goal is to be able to work
without pain and tingling
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10. Intervention
 Work station evaluation and adaptation
 Splinting
 Work rest periods with exercise
 Surgery
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11. Comparison
 Conservative program: splinting, rest periods,
work station adaptation, exercise (alone or in
combination)
OR
 Surgical intervention: arthroscopy or open
approach
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12. Outcome: ????
 Conservative intervention
– Effective to achieve the goal
– Risk: eventual surgery
 Surgical intervention
– Effective to achieve the goal
– Risk: Surgical failure; time lost from work
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13. What is our specific question?
For patients who have a confirmed diagnosis of Carpal Tunnel
Syndrome and whose symptoms at this time limited to pain and
tingling, is conservative management effective in reducing pain
and increasing function?
Is it complete?
•The patient and the condition
•The intervention
•The comparison (may or may not include in our search)
•The outcome
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14. Identify The Question
 Define the problem
 Identify the variables ?
Characteristics that can be
manipulated (intervention)or
observed (measurement of outcome)
MP Watkins,2008

15. How will you pursue the answer to
your clinical question? Is your
question complete enough to pursue?
YES? Let’s see what our choices are:
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16. Existing Information
http://servers.medlib.hscbklyn.edu/ebm/2100.htm
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17. Systematic Review
Definition: a process of summarizing research
evidence in an organized, rigorous way to
answer a clinical question.
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18. The process of Systematic Review
1. Refine a specific clinical question
2. Identify and obtain all relevant studies
3. Establish inclusion criteria
4. Systematically select studies that meet the criteria
5. Appraise the methodological quality of selected studies
6. Synthesize the data to answer the question
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19. The Systematic Review Process
Develop the Conduct a database Retrieve relevant
Clarify the need: Write protocol: identify search and review papers (4.0)
out a question that variables, other relevant
defines the information inclusion/exclusion sources (3.0)
needed to arrive at an criteria and
answer (1.0) evaluation method
(2.0) Develop a search
strategy (3.4)
Identify the first
Identify
choice site Select and
resources that
(Repeat until all organize key
include relevant
resources have words
information (3.1)
been (3.3)
included)(3.2)
Sort and select
Incorporate Information into a Evaluate the quality papers that meet
synthesis of the systematic of the studies (6.0) established criteria.
review (7.0) (5.0)
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20. Potential Problems
1. Selection bias
2. Selection of
inclusion criteria
subjects
method
operational definitions
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21. Meta-analysis
Definition: statistical analysis of
information from a series of
similar studies
Purpose: to synthesize and integrate
findings into an overall
interpretation of results
Benefit: effectively increases sample
size = increases power and
generalizability
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22. 1. What if the supporting evidence is not
sufficient or does not exist at all??
2. What if in our clinic there are several patients
with a similar condition?
3. Time to consider conducting clinically-based
studies…What are our reasonable choices??
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23. What about
one of these
categories?
http://servers.medlib.hscbklyn.edu/ebm/2100.htm
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24. Case Report
Purpose:
• to describe something new or unique
• to present usually ONE instance (one
patient)
• to perform an intense analysis of one case
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25. Case Report
 Introduction including background literature to support
elements of the case and what’s unique about the case
 Patient description: problem, symptoms, prior
treatment,….
 Methods
– Treatment plan and procedures (Intervention)
– Documentation methods (Measurement)
 Discussion with compare/contrast to prior background,
conclusion including future directions
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26. Sequential Clinical Trials
Purpose: to compare
2 treatments
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27. Sequential Clinical Trials
Advantages:
1. continuous analysis as data are
collected
2. the method is a statistical
technique
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28. Sequential Clinical Trials: Concept
and Technique
 Alternative treatments administered randomly
to pairs of subjects - a series of “little
experiments”
 Success criterion (“preference”) - determined
apriori
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29. Possible Outcomes
Outcome Treatment A Treatment B Preference
1 Improvement Improvement None
2 No improvement No improvement None
3 Improvement No improvement A
4 No improvement Improvement B
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30. Sequential Clinical Trials: Template
Boundary A
Boundary B
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31. Sequential Clinical Trials: the “numbers
problem”
 Minimum # in the example: 8 pairs
– What about the pairs with no preference?
 Maximum # : 58 pairs to reach either favorable choice
WHAT TO DO?
– Record and account for tied pairs
– Early termination: a clinical decision and a decision
based on the Research Question!!
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32. Sequential Clinical Trials: Example
32 MP Watkins, 2008 © Michlovitz, 1990

33. Sequential Clinical Trials:
Advantages
 Data analysis is simple
 The study is terminated as soon as a
preference is determined
 the impact on clinical decision-making can be
immediate
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34. Single case experimental designs
Purpose: to compare
2 or more treatments
(or treatment-no
treatment)
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35. Single case designs
 Advantage - study of individuals
(where individual characteristics may get lost in
group studies)
 Disadvantage - generalizability, but
fosters replication
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36. Single case experimental designs
Unique elements:
 Repeated measures of a “target”behavior
 Design phases over time - beginning with
“baseline”- usually designated by letters, e.g.
A,B,C…..
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37. Baselines….Definition of stability
© P & W Figure 12.2, 2009
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38. Single case designs: A - B
A B
© P & W Figure 12.1, 2009
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39. Single case designs: A - B - A
A B . . A
. .
. .
. .
. .
.
.
. . . .
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40. Multiple single case designs
 alternate treatment: A - B - A - C
 interactive treatment: A - B - BC - A
 multiple baseline across subjects
 staggered baseline
 multiple dependent measures
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41. Data Analysis
 Visual analysis: stability and trend
 Split middle technique - celeration lines
Two standard deviation band method.
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42. 20
18
16
14
Target Behavior
A 12
10
8
6
4
2
0
1 3 5 7 9 11 13 15 17 19
20
Treatment Sessions
16
Target Behavior
12
8 C
B 4
0
1 2 3 4 5 6 7 8 9 10
Sessions
20
16
Target Behavior
Fig. 12.14
E 12
D E 8
4
0
1 2 3 4 5 6 7 8 9 10
Sessions
© Figure 12.12 Portney & Watkins
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43. 43 MP Watkins, 2008
© Figure 12.13 Portney & Watkins, 2009

44. Example
To compare the effectiveness of two
taping methods for treatment of
plantar fasciitis for pain, disability and
activities of daily life.
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45. 2 standard deviation band analysis
Mean & standard deviations were calculated for
each phase
 Lines were drawn 2SD above & below the mean &
extended into the successive intervention phase
 Where at least two successive data points fell
outside the 2SD band, changes were considered
significant
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46. 46 10.5 A 56.5 B A C
4 1 5 LowDye Double X
70
0 0 0
600 0 0
500 0 0
Scores
0 0 0
40
4 8 12 Pain
302 0 2
200 0 0
0 0 0
10
16 48 64
14
0 12 26
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Days
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47. Summary
To define and explore methods for integrating
research activities and clinical practice.
– We reviewed the principles of evidence based
practice to use the best available research- based
data and the approach of systematic review
– We considered kinds of studies that are suited to
clinical practice and that contribute to the process of
establishing sound evidence of effective, timely
patient care.
47 MP Watkins, 2008

48. Web- based References
 Atkins C, Sampson J. Critical Appraisal Guidelines for Single Case
Study Research. Available at: <
http://is2.lse.ac.uk/asp/aspecis/20020011.pdf > Accessed September
12, 2008.
 Aldridge J. Single Case Research Designs for the Clinician.
Available at: <
http://www.musictherapyworld.net/modules/archive/stuff/papers/Sing
Case.pdf > Accessed September 12, 2008
 Greenhalgh, T. How to read a paper: Papers that summarise other
papers (systematic reviews and meta-analyses). Available at: <
http://www.bmj.com/cgi/content/full/315/7109/672 > Accessed
September 12, 2008
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49. Text References
 Law M, MacDermid J. Evidence-Based
Rehabilitation. Thorofare, NJ: Slack Inc, 2008
 Portney LG, Watkins MP. Foundations of
Clinical Research. Applications to Practice.
Upper Saddle River, NJ: Pearson Prentice
Hall, 2009
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