Research alternatives oct 22 final

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Research Alternatives for Clinical Practice

Mary P. Watkins, DPT, MSFaculty EmeritaMGH Institute of Health ProfessionsBoston, Massachusetts

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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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Identify The Question

Define the problem

Identify the variables

Characteristics that can be

manipulated (intervention)or

observed (measurement of outcome)

?

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What about all that information that already exists?

How can we access it?

What can we learn from it?

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Evidence Based Practice

The PICO Model

The Search for Evidence

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Introduction :

Definition of the PICO Model A case example Asking the question Planning the Search

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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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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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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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Intervention

Work station evaluation and adaptation Splinting Work rest periods with exercise Surgery

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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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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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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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Identify The Question

Define the problem

Identify the variables

Characteristics that can be

manipulated (intervention)or

observed (measurement of outcome)

?

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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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Existing Information

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Systematic Review

Definition: a process of summarizing research evidence in an organized, rigorous way to answer a clinical question.

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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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The Systematic Review Process

Clarify the need: Write out a question that defines the information needed to arrive at an answer (1.0)

Conduct a database search and review other relevant sources (3.0)

Identify the first choice site (Repeat until all resources have been included)(3.2)

Select and organize key words (3.3)

Identify resources that include relevant information (3.1)

Retrieve relevant papers (4.0)

Sort and select papers that meet established criteria. (5.0)

Incorporate Information into a synthesis of the systematic review (7.0)

Develop a search strategy (3.4)

Develop the protocol: identify variables, inclusion/exclusion criteria and evaluation method (2.0)

Evaluate the quality of the studies (6.0)

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Potential Problems

1. Selection bias

2. Selection of

inclusion criteria

subjects

method

operational definitions

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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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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??

MP Watkins, 200823http://servers.medlib.hscbklyn.edu/ebm/2100.htm

What about one of these categories?

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• to describe something new or unique

• to present usually ONE instance (onepatient)

• to perform an intense analysis of one case

Purpose:

Case Report

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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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Sequential Clinical Trials

Purpose: to compare 2 treatments

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Sequential Clinical Trials

Advantages:

1. continuous analysis as data are collected

2. the method is a statistical

technique

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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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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

Possible Outcomes

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Boundary A

Boundary B

Sequential Clinical Trials: Template

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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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Sequential Clinical Trials: Example

© Michlovitz, 1990

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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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Single case experimental designs

Purpose: to compare 2 or more treatments (or treatment-no treatment)

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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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Single case experimental designs

Repeated measures of a “target”behavior

Design phases over time - beginning with “baseline”- usually designated by letters, e.g. A,B,C…..

Unique elements:

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Baselines….Definition of stability

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Single case designs: A - B

A B

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Single case designs: A - B - A

. .. . .

..

. ..

.A B A. ..

..

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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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Data Analysis

Visual analysis: stability and trend

Split middle technique - celeration lines

Two standard deviation band method.

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Figure 12.15

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© Figure 12.13 Portney & Watkins, 2009

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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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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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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.

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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/SingCase.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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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