Evidence-Based Practice Notes
Minimizing Bias
- Bias can be minimized or overcome by using Bayes’ Theorem.
- Bayes’ Theorem involves updating prior beliefs based on new information.
- Start with a prior belief (A).
- Obtain new information (B).
- Update the belief accordingly (A given B).
Statistics/Research Usage
- Statistics and research can be used to:
- Describe the world.
- Assess causal effects between variables.
- Predict outcomes.
Evidence-Based Practice (EBP)
- EBP is the integration of best research evidence with clinical expertise and patient values.
- It also encompasses the conscientious, explicit, and judicious use of current best evidence in making decisions about patient care (Sackett, 1996).
- EBP combines:
- Research evidence
- Clinical expertise
- Patient values
Traditional vs. Evidence-Based Decision Making
- Traditional decision-making relies on:
- Experience and judgment.
- Clinical circumstances.
- Patient preferences.
- Evidence-based decision-making incorporates:
- Experience and judgment.
- Clinical circumstances.
- Patient preferences.
- Scientific evidence.
The Necessity of EBP
- EBP is crucial because of:
- The overwhelming volume of information.
- Described as "drinking from a fire hydrant."
- Waste in health research.
- Chalmers & Glasziou (2009) indicate that 50% of health research resources are wasted at each step, resulting in 85% overall waste.
- Mistakes arising from flawed theories.
- Hormone replacement therapy, which theoretically reduced cardiovascular risk, increased the incidence of breast cancer in women.
Clinical Decision Example (Hypertension Treatment)
- Clinical decisions in hypertension treatment are based on:
- Level of blood pressure.
- Patient’s age.
- Physician’s year of graduation from medical school.
- Amount of target-organ damage.
Continued Skills
- It's important to keep clinical skills up to date.
Causes of Research Waste
- Low-priority questions are addressed.
- Important outcomes are not assessed.
- Clinicians and patients are not involved in setting research agendas.
- Over 50% of studies are designed without reference to systematic reviews of existing evidence.
- Over 50% of studies fail to take adequate steps to reduce biases (e.g., unconcealed treatment allocation).
- Over 50% of studies are never published in full.
- There is biased under-reporting of studies with disappointing results.
- Over 30% of trial interventions are not sufficiently described.
- Over 50% of planned study outcomes are not reported.
- Most new research is not interpreted in the context of systematic assessment of other relevant evidence.
Additional Reasons for EBP
- Knowledge evolves rapidly, demanding efficient methods to stay current.
- Resources (time and money) are limited.
- Variations exist in practice patterns, with reliance on authority over empirical evidence.
- A gap persists between current knowledge and its application to care.
Bridging the Gap
- EBP aims to bridge the gap between what we know and what we do.
Practitioner Status
- A study of 321 PTs in England & Australia found that:
- Over 90% of treatment choices reflected initial training.
- Research literature was the least important factor in choosing techniques; review articles fared only slightly better (Turner & Whitfield, 1997).
Barriers to EBP
- APTA survey identified top barriers:
- Lack of time to read research.
- Lack of available research for specific patient populations.
- Lack of easy access to research.
- Lack of time to learn how to apply EBP.
- Jette et al. (2003) found that:
- Most PTs consider EBP important.
- 34% had low confidence in search abilities.
- 44% had low confidence in interpretation abilities.
- Older PTs are less likely to have training, less familiar with systems, and have less confidence overall.
Barriers to EBP for Stroke
- Common barriers:
- Insufficient time.
- Lack of generalizability of research findings.
- Lack of research skills.
- Lack of understanding of statistics.
- Inapplicability of research to unique patients.
- Inability to critically appraise.
- Isolation from peers.
- Lack of information resources.
- Lack of an organizational mandate.
Definition of Evidence
- "Not everything that can be counted counts, and not everything that counts can be counted." - Albert Einstein
- Emphasis on the best available external clinical evidence.
Practitioner Needs
- Practitioners need:
- Theory: Justifications for treatment based on basic or applied work answering why something should work.
- Evidence: Justifications for treatment based on applied work (on patients) answering if something works.
Example: Spinal Stability
- Less Useful:
- Devoid of muscle, the spine is unstable.
- Strengthening key muscles can lead to a stable spine.
- A more stable spine should decrease the risk of recurrence of LBP.
- More Useful:
- A randomized clinical trial demonstrates that pain and function improve initially and at 1- and 3-year follow-up in patients with LBP undergoing specific stabilization exercises (O'Sullivan et al., 1997).
APTA Strategic Plan
- Goal: Transform the profession.
- Best practices in education will lead to physical therapist practice marked by value and associated with the use of evidence, best practice principles, and outcomes research.
- Strategies include:
- Addressing unwarranted variations in clinical practice.
- Integrating the movement system.
- Engaging with the Education Leadership Partnership.
- Providing professional development opportunities for faculty.
- Advancing diversity and inclusion.
- Promoting PT participation in primary care delivery models.
- Assessing current strategies for advancing PT health services and outcomes research.
Fundamental Principles of Evidence
- Considerations:
- Benefits and risk
- Inconvenience
- Costs
- Patient values
- The evidence is never enough; a hierarchy of evidence exists.
Hierarchy of Evidence
- Address two questions:
- Where does an individual article fall on the hierarchy?
- Where does the preponderance of literature place the question?
Levels of Evidence (Individual Studies)
- 1a: Systematic Review of RCTs
- 1b: Individual RCT
- 2a: Systematic Review of Cohort Studies
- 2b: Individual Cohort Study
- 2c: Outcomes Study
- 3a: Systematic Review of Case-Control Studies
- 3b: Individual Case-Control
- 4: Case Series
- 5: Expert Opinion
Types of Studies in Hierarchy
- Case Study
- Systematic Review
- Meta-Analysis
- Case Control
- Clinical Practice Guideline
- Randomized Controlled Trial (RCT)
- Cohort Study
Randomized Controlled Trial (RCT)
- Definition: A study in which participants are randomly allocated to different clinical interventions.
RCT Advantages
- Good randomization washes out population bias.
- Easier to blind/mask compared to observational studies.
- Results can be analyzed with well-known statistical tools.
- Populations of participating individuals are clearly identified.
RCT Disadvantages
- Expensive in terms of time and money.
- Volunteer biases may lead to a non-representative population.
- Does not reveal causation.
- Loss to follow-up can be attributed to treatment.
Example: Beta-Alanine Study
- Study: No Effect of β-alanine on Muscle Function and Kayak Performance (Bech et al., 2018).
- Purpose: To investigate if β-alanine supplementation counteracts muscular fatigue or improves athletic performance.
- Methods: Elite kayak rowers supplemented with β-alanine or placebo for 8 weeks.
- Results: No detectable effect of β-alanine supplementation on kayak ergometer performance.
- Conclusions: Two-minute MVC characteristics are unaffected by β-alanine supplementation in elite kayakers.
Cohort study
- A study design where one or more samples (called cohorts) are followed prospectively and subsequent status evaluations with respect to a disease or outcome are conducted to determine which initial participants exposure characteristics (risk factors) are associated with it
Cohort study Advantages
- Subjects in cohorts can be matched, which limits the influence of confounding variables
- Standardization of criteria/outcome is possible
- Easier and cheaper than a randomized controlled trial (RCT)
Cohort study Disadvantages
- Cohorts can be difficult to identify due to confounding variables
- No randomization, which means that imbalances in patient characteristics could exist
- Blinding/masking is difficult
- Outcome of interest could take time to occur
Case-Control Study
- Definition: A study that compares patients who have a disease or outcome of interest (cases) with patients who do not have the disease or outcome (controls).
- Looks back retrospectively to compare how frequently the exposure to a risk factor is present in each group to determine the relationship between the risk factor and the disease.
Case-Control Study Advantages
- Good for studying rare conditions or diseases
- Less time needed to conduct the study because the condition or disease has already occurred
- Lets you simultaneously look at multiple risk factors
- Useful as initial studies to establish an association
- Can answer questions that could not be answered through other study designs
Case-Control Study Disadvantages
- Retrospective studies have more problems with data quality because they rely on memory
- People with a condition will be more motivated to recall risk factors (also called recall bias).
- Not good for evaluating diagnostic tests because it’s already clear that the cases have the condition and the controls do not
- It can be difficult to find a suitable control group
Case Report
- Definition: An article that describes and interprets an individual case, often written in the form of a detailed story
- Unique cases that cannot be explained by known diseases or syndromes
- Cases that show an important variation of a disease or condition
- Cases that show unexpected events that may yield new or useful information
- Cases in which one patient has two or more unexpected diseases or disorders
- Case reports are considered the lowest level of evidence, but they are also the first line of evidence, because they are where new issues and ideas emerge
Systematic Review
- Definition: A document often written by a panel that provides a comprehensive review of all relevant studies on a particular clinical or health-related topic/question
Systematic Review advantages
- Exhaustive review of the current literature and other sources (unpublished studies, ongoing research)
- Less costly to review prior studies than to create a new study
- Less time required than conducting a new study
- Results can be generalized and extrapolated into the general population more broadly than individual studies
- More reliable and accurate than individual studies
- Considered an evidence-based resource
Systematic Review disadvantages
- Very time-consuming
- May not be easy to combine studies
- Definition: A subset of systematic reviews; a method for systematically combining pertinent qualitative and quantitative study data from several selected studies to develop a single conclusion that has greater statistical power
- Used to establish statistical significance with studies that have conflicting results
- Develop more correct estimate of effect magnitude
- Greater statistical power
- Confirmatory data analysis
- Greater ability to extrapolate to general population affected
- Considered an evidence-based resource
- Difficult and time consuming to identify appropriate studies
- Not all studies provide adequate data for inclusion and analysis
- Requires advanced statistical techniques
- Heterogeneity of study populations
Practice Guidelines
- Definition: A statement produced by a panel of experts that outlines current best practice to inform health care professionals and patients in making clinical decisions
Practice Guidelines Advantages
- Created by panels of experts
- Based on professional published literature
- Practical guidance for clinicians
- Considered an evidence-based resource
Practice Guidelines Disadvantages
- Slow to change or be updated
- Not always available, especially for controversial topics
- Expensive and time-consuming to produce
- Recommendations might be affected by the type of organization creating the guideline
GRADE
- Lower quality if: Study limitations, Inconsistency, Indirectness, Imprecision, Publication bias
- Higher quality if: Large effect, Dose response
Steps in EBP
- Identify the need for information and develop a question
- Conduct a search for the best possible evidence
- Critically appraise the evidence
- Integrate the evidence with clinical expertise and patient values
- Evaluate the effectiveness and efficacy of your efforts
EBP methodology
- Precisely defining a question related to a patient problem or question
- Accessing and synthesizing evidence useful in answering the questions
- Applying the knowledge to patient care
The Evidence Cycle
- Ask
- Acquire
- Appraise
- Apply
- Assess
Background vs Foreground
- Background
- General knowledge about disease or intervention
- Foundational knowledge about clinical condition
- Reflect a desire to understand the nature of an individual’s desire or need
- Foreground
- Help you obtain specific knowledge
- Assist in developing diagnosis, prognosis, or plan of care for a specific patient
Example: ACL
- Background:
- What is the typical mechanism of injury for an ACL?
- Foreground
- For individuals 35-50 who are post-surgical ACL repair does the use of a CPM machine improve their return to sporting activities?
Defining the Question: PICO
- Patient (or Problem)
- How would I describe a group of patients similar to mine?
- Intervention (or cause, prognosis)
- Which main intervention am I considering? Be specific.
- Comparison (or control)
- What is the main alternative? Be specific.
- Outcome(s)
- What do I hope to accomplish?
How Much Do You Need To Read?
- Clinicians need only about 20 articles per year and 5 to 50 articles in a specialty
- Need to consume 1-2% of published evidence
- How do we identify what we need to know?