HTHSCI 3CO4 Cheat Sheet

Introduce Research

• Study design/methods
• Appraisal
• Interpretation
• Application/utilization

Understand

• Evidence Informed Decision Making Model
• Sources of Evidence
• Types of research that inform practice (quantitative, qualitative, mixed methods)
• Why research studies should be critically appraised

1.2 Research, EBP & EIDM

• There are different ways of knowing; Empirical, Personal, Aesthetics, Ethical

1. Empirical (focus of class)

• Theories, models, facts
• Validation, confirmation
• Scientific competence

2. Personal knowledge

• Person stories, self
• Reflection, response
• Therapeutic use of self

3. Aesthetics knowledge

• Experience of nursing, health, illness
• Appreciation, grasp meaning
• Transformative act/acts

4. Ethical Knowledge

• Principles, codes
• Justification, dialogue

Evidence-Based Practice (EBP)

• A paradigm (model) and life-long problem solving approach to clinical decision-making that involves the conscientious use of the best available evidence (including a systematic search for and critical appraisal of the most relevant evidence to answer a clinical question) with one's own clinical expertise and patient values and preferences to improve outcomes for individuals, groups, communities, and systems
• Research utilization is different from EBP- utilization is just focused on using research and looking at the findings of research
• In the past, EBP was often criticized for being restrictive

Why must we use Evidence-Based Practice (EBP)?

• There are billions of dollars spent on health-related research
• It takes ~17 years to get research into recommended policy or practice (this is outrageous)
• 30-50% of people receive recommended care but 30-40% of patients do not get evidence-based care, they instead get care that is known to be ineffective or even harmful
• EBP improves outcomes, assesses risk vs harm for patients, we need to get into EBP to decrease the amount of time to get research into recommended policy

EIDM in a Clinical Setting (Clinical Expertise) - Model

1. Clinical state, setting and circumstances
2. Patient preferences and actions
3. Research evidence
4. Health care sources

• When making decisions, you must factor all of these bubbles and these bubbles may scale differently

• Think of context, preferences, evidence, and resources

7 Steps of EIDM

1. Define: Define the clinical issues & formulate a focused, structured research question (could be PICO or PS)
2. Search: conduct an efficient literature search to find evidence (search databases)
3. Appraise (focus of our class): critically appraise the evidence
4. Synthesize: combine & summarize evidence
5. Apply: Apply evidence to clinical issue and make decision using clinical expertise, patient's preferences and consideration of resources
6. Implement: implement intervention/treatment
7. Evaluate: outcome

1.3 The Research Process

1. Question formulation

• Identify a clinical problem or issue
• Review & critical appraisal of the research literature (for pre-context)
• Determine the need for & purpose of research

2. Study design & planning
3. Data collection
4. Data analysis
5. Conclusions

• Implications for practice & future research

6. Dissemination of study findings

• Spreading and sharing study findings

7. Utilization

• Apply research findings to clinical practice

• Here, you can see how research process ties into EBP

Study Designs & Methods

• Methods section needs to be very detailed; the designs and research methods should match the purpose of research and research question
• They must describe in detail the methods and design to know what was done
• They must have established criteria for appraising the appropriateness of the methods and assessing the validity of the results
• The design and methods should always follow from the research question (the question determines the method)
• Study designs and research methods should match the purpose of research and the type of question to be answered

Types of Research Methods

1. Quantitative Research (objective)

• Generates numerical data and results (raw data)
• Data collected using reliable & valid measurement tools
• Involves statistical anaylsis of data, usually 1/3 types; descriptive (prevalence of events/conditions, means and standard deviations), comparative (ex, difference in mean depression scores between intervention and control group), relationship (factors shaping quality of life)
• Quantitative study designs can be experimental or non-experimental
• Experimental designs are interventions such as randomized controlled trials or quasi-experimental
• Non-experimental designs are observational studies such as cohort design, case-control study, or cross-sectional study

2. Qualitative Research (subjective)

• Used to explore beliefs, experiences, attitudes, behaviors & interactions
• Generates non-numerical data
• Data collected through focus groups, individual interviews, document review, participant observation, etc
• Involves anaylsis of narrative data
• The big three of qualitative research designs includes grounded theory (sociology) which focuses on developing theory from data, phenomenology (philosophy) which focuses on experiences and ethnography (anthropology) which focuses on people and their cultures
• Other designs that are commonly used are qualitative descriptive (just describes), interpretive description (trying to extend and interpret raw data), focused ethnography, case studies

3. Mixed Methods Research

• Methodology that involves collecting, analyzing and integrating quantitative (ex, experiments, surveys) and qualitative (ex, focus groups, interviews) research

• Here, qualitative data can be collected and analyzed to support the development of the intervention, understand contextual factors related to the implementation of the intervention, and/or explain results

Research Questions (formulating the research question)

1. Quantitative (PICO) format for foreground questions

• P: Population
• I: Intervention/Exposure
• C: Comparison/Counter exposure
• O: Outcome
• Ex, In adults with untreated hypertension, what is the effect of polyphenol-rich dark chocolate compared to white chocolate in lowering blood pressure?
• Make sure you don't give accidental bias or direction

2. Qualitative- PS format for foreground question

• P: Population
• S: Situation
• Ex, What are the caregiving experiences of first generation immigrant parents of children with cancer?

1.6: Focused, Structured & Answerable Research Questions

Q: Why Write a Focused Research Question?

• PICO(T) & PS questions-> are searchable, answerable questions created from clinical issues
• The question determines the research method-> the best evidence comes from studies that use the study design most appropriate for the question -> seek pre-appraised evidence first (as high up the pyramid), and if there isn't any, then critically appraise studies yourself

Developing a Well-Built Clinical Q

• The anatomy consists of either PICO or PS
• The Question needs to identify 1) the key problem of the patient 2) what treatment or tests you are considering for the patient 3) what alternative treatment or tests are being considered (if any) and, 4) what is the desired outcome to promote or avoid
• Two additional elements to consider in building a clinical question is the 1) the type of question and 2) the type of study
• Remember the question determines the research method/study design

• If there is harm to a patient or in situations where it is dangerous to not receive a medication, we do not use a RCT
• Remember cohort, case controls and cross-sectional studies are quantitative data (non-experimental)

Acquiring the Evidence to Answer Well-Built Clinical Questions

• Constructing a well-built clinical question can lead directly to a well-built search strategy
• You may not use all the information in the clinical question for your search strategy
• Example:

1.7 The 5S & 6S Pyramids

Critical Appraisal

• Addresses two broad questions:

1. Internal validity: are the research design and methods likely to produce results that are true or valid? (think small first)
2. External validity: If the answer to the first question is 'yes', can the results be applied to the clinical issue or problem?

• There are several sources of pre-appraised and summarized research to simplify critical appraisal (5S/6S pyramid… see later)
• Where pre-appraised research is not available, current critical appraisal tools specific to each study design exist to help you conduct your own critical appraisal

Putting it all together

• Empirical knowledge= research evidence
• EBP & EIDM: Use of research evidence in clinical decision-making (combined with patient situation & preference , resources, expertise)
• Critical appraisal: finding high quality evidence for EBP & EIDM
• Critical appraisal recognizes that different clinical questions require different study designs as the question determines the method
• Final evidence- start at the top of the pyramid!

• In the 6S pyramid, guidelines are summaries, systematic reviews are syntheses, and individual studies are at the bottom

Hills Criteria of Causation (background)

• Hill was a British medical statistician (1897-1991) who developed 9 criteria for determining the causal link between a specific factor and a disease

Uses of Hill's criteria:

• Basis of epidemiological research, which attempts to establish scientifically-valid causal links between potential disease agents and many diseases
• Identification of study designs offering strongest evidence
• Appraising evidence obtained from multiple studies

1. Temporal Relationship

• Exposure always precedes the outcome
• "For example; if factor "A" is believed to cause the disease, then factor "A" must always precede the occurrence of the disease

2. Strength of Association

• The stronger the association, the more likely the relationship between "a" and "b" is causal
• For example; the higher the correlation between sodium consumption and hypertension, the stronger the relationship between sodium and hypertension
• The higher the odds of 30-day hospital re-admission in post-surgical patients, the stronger the relationship between surgery and 30-day hospital re-admission

3. Dose-response Relationship

• An increasing amount of exposure (dose), increases the amount of response (outcome)
• If a dose-relationship relationship exists-> stronger evidence for causal relationship (compared to absence of relationship)
• Similarly, if a certain factor is the cause of a disease, the incidence of a disease should decline when exposure to the factor is reduced or eliminated

4. Consistency of Association

• Finding a consistent relationship between a factor and outcome across different studies with different populations-> stronger evidence of causal relationship (compared to inconsistent findings)

5. Biological Plausibility

• Association agrees with accepted understanding of pathological processes (there needs to be a theoretical basis aka it needs to make sense) from physiological/pathophysiological perspective

6. Experimental Evidence

• The association between exposure and outcome can be supported with experimental evidence -> is there research to substantiate this causal relationship

7. Alternate Explanations

• Determine the extent to which researchers have taken other possible explanations into account and ruled out these alternate explanations (leaves this explanation to standalone)

8. Specificity

• Established when a single cause produces a specific effect (single cause causes a specific effect)
• Weakest of criteria for causation
• Absence of specificity does not negate a causal relationship

9. Coherence

• The association should be compatible with existing theory and knowledge
• Can be substantiated through existing theory or prior knowledge

Features, Advantages & Disadvantages of Different Quantitative Designs

Q: What is a study design?

• Refers to the way a study is organized/constructed & methods used
• Quantitative Study designs are best for questions about:

1. Cause of disease (etiology)
2. Prognosis
3. Diagnosis
4. Prevention
5. Treatment
6. Economics of a health problem

Q: Quantitative Study Designs: Hierarchy

1. Experimental Designs (best)

• RCTs ; patients are randomly assigned to treatment groups
• In order for randomization to occur, there should be a equal chance for individuals to be in intervention or treatment group
• You can do this by generating a randomizer sequence via computer and allocation of sequence is concealed (no one can manipulate sequence)
• Point of randomization is to ensure each of groups are balanced in terms of confounders
• We want to ensure they're balanced because they can influence the outcome
• RCT is gold standard because we can be confident that this intervention caused this outcome
• Participants are followed forward in time (prospectively) from exposure to outcome
• Two types outcomes can be measured; continuous and discrete ; continuous outcomes are numeric values that can continually be evaluated such as BP and measured, meanwhile discrete outcomes are more concrete such as outcomes such as yes or no

Q: What are some strengths and weaknesses of RCT?