© 2006 evidence-based chiropractic 1 evidence-based chiropractic ii michael t. haneline, dc, mph...
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Evidence-based Chiropractic 1 © 2006
Evidence-based Chiropractic II
• Michael T. Haneline, DC, MPH
• http://w3.palmer.edu/michael.haneline– PP presentations– Articles and checklists for class workshops– Sample test questions– Syllabus, etc.
Evidence-based Chiropractic 2 © 2006
Evidence-based Chiropractic II
• Required text:– Evidence-based Chiropractic
Practice. Haneline M. Jones & Bartlett Publishers
• Read chapters before pertinent class sessions
• Exam questions are taken from the text
Evidence-based Chiropractic 3 © 2006
• Topics– Elementary biostatistics – Research design– Literature searching strategies– Outcome measures and the importance of
their use in a chiropractic practice – Class workshops appraising several articles– Literature searching workshop in the library
Syllabus
Evidence-based Chiropractic 4 © 2006
Course Goals
• To assist students in becoming critical thinkers in chiropractic practice
• To teach students to find, acquire, read, critically appraise, understand and apply information published in scholarly periodicals
• To relate research to clinical practice and clinical practice to scholarship
Evidence-based Chiropractic 5 © 2006
Projects
• Case Report Critical Appraisal
• Literature Review Critical Appraisal
• Reliability of Outcome Measures Critical Appraisal
• Randomized Clinical Trial Critical Appraisal
• EBC 5-step project
© 2006
Evidence-based Chiropractic Practice
The best available research evidence, combined with clinical
expertise and patient values.
Evidence-based Chiropractic 7 © 2006
What is Evidence-based Chiropractic (EBC)?
• EBC developed out of a movement started by a group of medical educators at McMaster’s University during the 1980s
• These physicians observed that a gap had developed between what occurred in clinical practice and what was obtainable in reports of clinical research
Evidence-based Chiropractic 8 © 2006
What is EBC? (cont.)
• Essentially, clinicians could not stay abreast with new research because it was being produced so fast; consequently they were not putting into practice the most current information
• Evidence-based methods were designed to bridge this gap
Evidence-based Chiropractic 9 © 2006
What is EBC? (cont.)
• Originally known as evidence-based medicine (EBM)– The concept has been
embraced by thechiropractic profession (and others)
Evidence-based Chiropractic 10 © 2006
EBC is unique in several ways
1. Chiropractic interventions (manipulation) are difficult to investigate by experimental methods
– Difficulty in designing an effective placebo– It is difficult to blind both doctors and
patients
• As a result, there are fewer chiropractic articles that use a placebo control group than other disciplines
Evidence-based Chiropractic 11 © 2006
EBC is unique (cont.)
2. Chiropractors commonly utilize multiple treatment modalities
– A variety of manipulations, exercises, ergonomic advice, physiotherapy, etc.
• In contrast, clinical trials often utilize only one modality
– In order to isolate it and compare it with a placebo or an alternative therapy
Evidence-based Chiropractic 12 © 2006
EBC is unique (cont.)
3. Finances were very limited for chiropractic research in the past which hampered progress
– High-quality research is very expensive
• Things have changed in recent years– Federal funds are increasingly becoming
available – Numerous elegant chiropractic studies have
resulted
Evidence-based Chiropractic 13 © 2006
• The uniqueness of chiropractic research has produced a correspondingly unique evidence base of chiropractic information
• Studies may appear to be less rigorous than for other forms of treatment
• Nonetheless, many studies are available to support and help direct chiropractic patient care
A unique evidence base
Evidence-based Chiropractic 14 © 2006
Evidence-based practice (EBP) is
• “. . . the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.”
David Sackett, MD
Evidence-based Chiropractic 15 © 2006
EBP incorporates the skills of the doctor
• The practitioner’s clinical expertise is integrated with the best available external clinical evidence from systematic research – Clinical expertise: the skills and knowledge
gained by clinicians through clinical experience and practice
• EBP relies heavily upon the practitioner’s past clinical experience
Evidence-based Chiropractic 16 © 2006
EBP is not a “cookbook” method of practice
• It is the integration of the best evidence with the past training and expertise of the clinician, which results in better care for the patients
• Evidence is added to patient care to replace outdated information
Evidence-based Chiropractic 17 © 2006
Patient preferences
• The personal values, concerns, and expectations that patients have about their care
• Taking patient preferences into consideration is an essential step in the EBP process
Evidence-based Chiropractic 18 © 2006
Patient preferences (cont.)
• Personal values – The beliefs patients have about the care that
is being offered to them– May be related to philosophical or even
religious issues
• Patient concerns – e.g., financial issues, time constraints, and
office location
Evidence-based Chiropractic 19 © 2006
Patient preferences (cont.)
• Patient expectations – The degree that patients accept a doctor’s
recommendations– Often wide-ranging and can have a significant
impact on clinical results
Evidence-based Chiropractic 20 © 2006
EBC is . . .
• Actively seeking support for and improvement of chiropractic clinical practice through the integration of the best available research evidence, combined with clinical expertise and patient values.
Evidence-based Chiropractic 21 © 2006
EBC is . . .
Evidence-based Chiropractic 22 © 2006
Why EBP?
• Practitioners may not have enough information to answer clinical questions– Complicated cases– Patients sometimes ask difficult questions
• The need to stay current in light of an overwhelming amount of new research– Must be able to distinguish the good from the
bad
Evidence-based Chiropractic 23 © 2006
Why EBP? (cont.)
• Best practices– Use of the most valid clinical tools available – Established through research
• To determine the most effective form of treatment – Is there any associated harm?
• Utilize valid and reliable diagnostic tests
Evidence-based Chiropractic 24 © 2006
Why EBP? (cont.)
• Better reimbursement – Insurance companies
often pay for services when provided with an explanation grounded in credible evidence that justifies the clinical procedures
Evidence-based Chiropractic 25 © 2006
When EBP?
• Patient-specific– Patients who present for care with unusual
conditions that are unknown to the practitioner
• Is the patient a good candidate for chiropractic care?
• What are the best case management options? • Are there contraindications to manipulation?• Should the patient be referred elsewhere?
Evidence-based Chiropractic 26 © 2006
When EBP? (cont.)
• Condition-specific– Practitioners become familiar with unknown
conditions – After the patient presents for care
• Reactive learning
– Before the patient presents for care • Proactive learning • Achieved by consistently reading current evidence
Evidence-based Chiropractic 27 © 2006
When EBP? (cont.)
• Self education– Attending seminars and conferences
• How informed is the speaker and how accurate and current is the material?
– Practitioners gathering the best available evidence on their own
• Journal articles are the most dependable source• Textbooks and prior knowledge become obsolete
rapidly as new information becomes available
Evidence-based Chiropractic 28 © 2006
It takes time and practice to learn EBP methods
• Some elements of EBP are difficult to master (e.g., research methods and biostatistics)
• Make time to read journal articles– Peruse abstracts, then read the entire articles
of those that are of interest
• Set aside time to search for answers to clinical questions
Evidence-based Chiropractic 29 © 2006
The five steps of EBP
1. Ask a clinically relevant question 2. Search the literature to find the best available
evidence to answer your question 3. Appraise the evidence for validity and
applicability to the clinical circumstances 4. Apply the relevant evidence to the clinical
situation 5. Evaluate your effectiveness in carrying out
steps 1 through 4 and revise if necessary
Evidence-based Chiropractic 30 © 2006
Asking clinical questions
• Question should be clinically relevant – The answer will help with the management of
a particular patient or patients with a similar condition
• A good question will help guide the search for evidence toward relevant material – Can save a great deal of time
Evidence-based Chiropractic 31 © 2006
Two types of questions
1. Background questions– Simple two-part questions that address the
basic facts about a patient’s health problem– Do not fully address issues about the best
diagnostic or treatment options– This type of information can be acquired from
current textbooks and peer-reviewed and referenced electronic publications (e.g., Harrison’s Online)• http://www.merckmedicus.com
Evidence-based Chiropractic 32 © 2006
Types of questions (cont.)
2. Foreground questions – More complex than background questions – Apply to decisions about the most favorable
treatment or diagnostic strategies – Derived from
• Primary sources (journal articles of clinical studies)
• Secondary sources (expert reviews of all available original articles on a given topic)
Evidence-based Chiropractic 33 © 2006
Elements of a good clinical question (PICO)
• Patient or problem
• Intervention
• Comparison intervention (optional)
• Outcome(s) of interest – Should be of interest to patients (e.g., less
pain or disability)
Evidence-based Chiropractic 34 © 2006
PICO example
• Is manipulation effective at reducing back and leg pain in a middle aged female patient with lumbar spinal stenosis and concomitant radicular pain, or are any alternative methods more favorable?
P. A middle aged female patient with lumbar spinal stenosis and concomitant radicular pain
Q. Manipulation
R. Any alternative method that might be superior to manipulation
O. A reduction of lower back and leg pain
Evidence-based Chiropractic 35 © 2006
Patient-Oriented Evidence that Matters (POEMs)
1. The outcome in a study should be something patients care about
– Like morbidity or quality of life
2. The problem should be widespread and the intervention should be feasible
3. The information should have the potential to change the practice of many practitioners
Evidence-based Chiropractic 36 © 2006
Disease Oriented Evidence (DOE)
• Studies that involve outcomes that may be of interest to researchers and practitioners, but are of little interest to patients
• Surrogate end points are used as a substitute for clinically meaningful POEMs– Examples: range of motion, leg length
Evidence-based Chiropractic 37 © 2006
Example of a POEM
• A RCT showing that exercise along with manipulation leads to less low back pain and disability than manipulation alone
• Why?– Problem is encountered frequently in practice– The article considers pain, and disability as
the primary outcomes (patient oriented)– This should be a “practice-changer” for
chiropractors who use manipulation only
Evidence-based Chiropractic 38 © 2006
What is evidence?
• Something that is helpful in forming a conclusion or judgment
• Found primarily in journal articles that deal with: – The effectiveness and safety of treatments– The validity and reliability of diagnostic tests – The incidence and prevalence of diseases in
populations
Evidence-based Chiropractic 39 © 2006
Hierarchy of research evidence
Systematic reviews of RCTs are considered by
most to be the “gold standard” for determining if
a treatment is effective
Progressively fewer studies are available
as one advances from the lowest to the
highest levels of the evidence pyramid
Use the highest level of evidence possible to make clinical decisions
Evidence-based Chiropractic 40 © 2006
Progression of clinical investigation
• Clinical investigation typically begins with case reports/series, then advances to observational studies, and then to RCTs
• The final step is a systematic review after a few RCTs have been reported
Evidence-based Chiropractic 41 © 2006
A lower-level study may be better evidence
• Studies that rank higher on the hierarchy of evidence pyramid are not always better
• For instance, a single RCT that involved few subjects is not necessarily more credible than reliable results from a high-quality non-randomized trail
• Sometimes RCTs are of little value because of design flaws
Evidence-based Chiropractic 42 © 2006
Evidence in EBP is founded on science
• Science is . . .– The observation, identification,
description, experimental investigation, and theoretical explanation of phenomena
Evidence-based Chiropractic 43 © 2006
Founded on science (cont.)
• The scientific method – The principles and empirical processes of
discovery and demonstration considered characteristic of or necessary for scientific investigation, generally involving the observation of phenomena, the formulation of a hypothesis concerning the phenomena, experimentation to demonstrate the truth or falseness of the hypothesis, and a conclusion that validates or modifies the hypothesis
Evidence-based Chiropractic 44 © 2006
Practitioners should be able to interpret scientific reports
• Must be able to discriminate good- from poor-quality evidence
• Unfortunately, many do not understand basic research methods
• This state of affairs is changing– Continuing education for practitioners – Chiropractic students are now taught to
interpret scientific reports
Evidence-based Chiropractic 45 © 2006
Evidence rating systems
• Used to rate the quality and class structure of evidence
• Examples– Scottish Intercollegiate Guidelines Network
(SIGN)– Agency for Healthcare Research (AHRQ)– Oxford Centre for Evidence-based Medicine
(CEBM)
Evidence-based Chiropractic 46 © 2006
Rating systems (cont.)
• The relative strength of evidence depends on:– Position in the hierarchy of study designs– The study’s validity
• Refers to the degree that a study design is able to produce dependable results
Evidence-based Chiropractic 47 © 2006
SIGN levels of evidence
• 1++ – High quality meta-analyses, systematic reviews of RCTs, or
RCTs with a very low risk of bias
• 1+– Well conducted meta-analyses, systematic reviews of RCTs, or
RCTs with a low risk of bias
• 1−– Meta-analyses, systematic reviews of RCTs, or RCTs with a
high risk of bias
Evidence-based Chiropractic 48 © 2006
SIGN levels of evidence (cont.)
• 2++ – High quality systematic reviews of case-control or cohort
studies or High quality case-control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal
• 2+ – Well conducted case-control or cohort studies with a low risk of
confounding, bias, or chance and a moderate probability that the relationship is causal
• 2− – Case-control or cohort studies with a high risk of confounding,
bias, or chance and a significant risk that the relationship is not causal
Evidence-based Chiropractic 49 © 2006
SIGN levels of evidence (cont.)
• 3 – Non-analytic studies (e.g., case reports, case series)
• 4 – Expert opinion
Evidence-based Chiropractic 50 © 2006
Grades of recommendations
• Utilized by guidelines developers to make comments about the appropriateness of various treatment and diagnostic procedures
• Recommendations are based on the quantity and quality of evidence that is available
Evidence-based Chiropractic 51 © 2006
SIGN grades of recommendations
• A – At least one meta analysis, systematic review,
or RCT rated as 1++ and directly applicable to the target population or
– A systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+ directly applicable to the target population and demonstrating overall consistency of results
Evidence-based Chiropractic 52 © 2006
SIGN grades of recommendations (cont.)
• B– A body of evidence including studies rated as
2++ directly applicable to the target population and demonstrating overall consistency of results or
– Extrapolated evidence from studies rated as 1++ or 1+
Evidence-based Chiropractic 53 © 2006
SIGN grades of recommendations (cont.)
• C – A body of evidence including studies rated as
2+ directly applicable to the target population and demonstrating overall consistency of results or
– Extrapolated evidence from studies rated as 2++
Evidence-based Chiropractic 54 © 2006
SIGN grades of recommendations (cont.)
• D– Evidence level 3 or 4 or– Extrapolated evidence from studies rated as
2+
Evidence-based Chiropractic 55 © 2006
Critical appraisal
• Articles should be critically appraised to determine whether or not the information should be applied to the clinical circumstances – If valid and applicable, the information can be
utilized to make clinical decisions – If not, either reject the information or utilize
only those portions that are valid and applicable
Evidence-based Chiropractic 56 © 2006
Evidence is rarely definitive
• Especially true when considering only a single study
• The degree of confidence that one may have in evidence depends on– The strength (hierarchy/validity) of the
research and – How the various pieces of research on that
topic blend together
Evidence-based Chiropractic 57 © 2006
When there is little or no evidence
• The practitioner must decide whether or not to render treatment – Perhaps on a time and improvement
dependant trial basis or – Refer to an appropriate specialist for
autonomous or co-management of the case
• Bear in mind– No evidence of effect is not the same as
evidence of no effect
Evidence-based Chiropractic 58 © 2006
Chiropractic philosophy and EBC
• “The foundation of chiropractic includes philosophy, science, art, knowledge, and clinical experience.”
The Chiropractic Paradigm The Association of Chiropractic Colleges
• However, many chiropractors have a limited understanding of the concepts of philosophy
Evidence-based Chiropractic 59 © 2006
Philosophy and EBC (cont.)
• Many chiropractors think of philosophy as it relates to their fundamental beliefs and underlying principles about the profession – Thus, one is said to have a philosophy of
chiropractic
• This perception only comprises a small part of the word’s complete definition
Evidence-based Chiropractic 60 © 2006
Philosophy definition
1. The love and pursuit of wisdom by intellectual means and moral self-discipline
2. Investigation of the nature, causes, or principles of reality, knowledge, or values, based on logical reasoning rather than empirical methods
3. The critical analysis of fundamental assumptions or beliefs
4. A set of ideas or beliefs relating to a particular field or activity; an underlying theory
5. A system of values by which one lives
Evidence-based Chiropractic 61 © 2006
Philosophy and dogma
• A belief system taken to an extreme becomes dogma; defined as – An authoritative principle, belief, or statement
of ideas or opinion, especially one considered to be absolutely true
• Dogmatic practitioners may be reluctant to acknowledge new information and change their practices in response
Evidence-based Chiropractic 62 © 2006
Dogmatism
• The chiropractic profession at large is plagued with dogmatism that affects both sides of the political fence
Seaman
• Dogmatism is the principle barrier to a rational and unifying depiction of the role of chiropractors, as well as the furtherance of chiropractic science
Keating
Evidence-based Chiropractic 63 © 2006
The solution for dogmatism
• When used effectively, philosophy leads to a willingness to critically examine one’s beliefs
• Rather than being dogmatic, one should welcome new (better) evidence and try to incorporate it into patient care
Evidence-based Chiropractic 64 © 2006
EBC and philosophy are complementary
• There are no sacrosanct truths in chiropractic that should never be questioned
• Any conceivable chiropractic-related topic should be open for discussion