Exam 1 Flashcards
Evaluating Evidence
- thousands/millions of articles on many clinical research topics
- multiple designs and many interventions
- requires a system to evaluate the evidence
- Many systems that rank evidence
- no absolute correct or agreed upon system
- use as guide
- continually changing and being updated
Greenhalgh suggested what studies
- systematic reviews and meta-analyses
- RCTs with definitive results
- RCTs with non definitive results
- cohort studies
- case-control studies
- cross-sectional studies
- case reports
Oxford Centre for Evidence-Based Medicine 2011 Levels of evidence
- Level 1: systematic review of RTCs
- level 2: randomized trial or observational study with dramatic effect
- level 3: non-randomized controlled cohort/followup study
- level 4: case-series, case-control studies, or historically controlled studies
- Level 5: mechanism-based reasoning (formerly known as expert opinion)
Evaluating Research Reports
- critical analysis of research report (determines validity of report and applicability for clinical decisions)
- guidelines for reporting of studies (consort statement, enables reader to better assess validity of the results, many others eg STROBE)
- success of evidence-based practice dependent on incorporating research findings into clinical decision making
Quality of the journal
- when evaluating scientific merit of an article, consider journal’s reputation
- peer-reviewed/refereed journals (content experts, accepted based on recommendation of reviewers, processes ensure that articles meet standards)
Evaluating Components of a study
- clinicians and researchers evaluate literature from a number of perspectives
- what is the study’s intent? (problem under investigation)
- is the study sound in it’s methodology? (if no, results may not be valid, details of subjects how selected inclusion/exclusion, random assignment, blinding, reliable and valid measures, equal group treatment, etc)
- are results meaningful? (was there effect of interventinon? clinically and statistically important?)
- can results be applied to my pt.? (depends if pt. is similar to those studied, is treatment feasible in clinic, etc)
Searching for the evidence - good resources
- pubmed
- google scholar
- cochrane library
- PEDro
- CINAHL
- Embase
- Scopus
- PsycINFO
What is clinical research?
- structured and systematic
- objective process
- examines clinical conditions and outcomes
- establishes relationships among clinical phenomena
- provides evidence for clinical decision making
- provides impetus for improving practice
- relates to clinical phenomena (MMT, ROM, fall risks, balance confidence, glucose level - - should be able to doc and track most of these things)
- look at relationships…i.e. how strength/balance affects ADLs, how strength affects balance, etc
Shifts in Research Priorities in 20th century
- focus on OUTCOMES research to document EFFECTIVENESS
- application of MODELS of health and disability
- attention to EVIDENCE-BASED PRACTICE (EBP)
Measurement of Outcomes
- typically rehabilitation outcomes were related to improvements in pathologies or impairments
- Now outcomes include WHO definition of health to include physical, social, and psychological well-being
- consider patient satisfaction, self-assessment of functional capacity, quality of life
- now clinicians must document outcomes to substantiate effectiveness of treatment
Outcomes Research
- how successful are our interventions in clinical practice specifically in terms of disability and survival
- studies use large databases including info not only functional outcomes, but also utilization of services, insurance coverage, etc
Outcome Measures
- measure the effectiveness of treatment in terms of patient satisfaction and outcomes as well as in terms of revenue/costs; staff productivity
- questionnaires are often used to measure outcomes in terms of function and health status
- health status scales eg instruments such as the medical outcomes study short form 36 (SF36) reflects physical function, mental function, social function, and other (pain, etc)
Biomedical Model
- focuses on relationship between pathology and impairments
- physical aspects of health
- no consideration for how patient is affected by illness
Disablement Model: Nagi
- pathology: interference with normal bodily processes or structures
- impairment: anatomical, physiological, or psychological abnormalities
- functional limitation: inability to perform an activity in a normal manner
- disability: limitation in performance of activities within socially defined roles
ICF (international classification of functioning)
- describes how people live with their health condition
- has parallels to Nagi model
- health condition: pathology
- body function/structure: impairments
- activity: functional limitation
- participation: disability
- includes references to environmental and personal factors affecting function (contextual factors)
ICF Outcomes
- outcomes may be related to (targeted to) the impairment level (improving tone, ROM, strength, balance)
- but must also establish functional outcomes that influence performance at the activity or at the participation levels
- i.e. increasing strength and balance will allow the person to ambulate in the community and socialize with friends (activity level improved ambulation, participation level enhanced socialization)
Evidence-Based Practice (EBP)
- provision of quality care depends on ability to make choices that have been confirmed by sound scientific data, and that decisions are based on best evidence currently available
- begins by asking a relevant clinical question related to: patient diagnosis, prognosis, intervention, validity of clinical guidelines, safety or cost-effectiveness of care
what does “PICO” stand for: a good clinical question
- P: patients/population
- I: intervention
- C: comparison/control
- O: outcome of interest
- i.e. In a patient 2-weeks post-hip replacement (P), is active exercise (I) more effective than passive ROM exercise (C) for improving hip ROM (O)?
PICO
- question is precursor to searching for the best evidence to facilitate optimal decision making about a patient’s care
- terms in PICO can be used as search terms in a literature search for best evidence
- Clinicians search and access literature
- Critically appraise studies for validity
- Determine if research applies to their patient
Components of EBP for clinical decision making
- clinical expertise
- best research evidence
- clinical circumstances and setting
- patient values and preferences
Sources of knowledge for clinical decisions and to guide clinical research….How do we “know things”?
- tradition (always done this way)
- authority (expert opinion)
- trial and error (try something and if it fails try something else)
- logical reasoning
- scientific method
Logical Reasoning
- A method of knowing which combines experience, intellect, and thought
- systematic process to answer questions and acquire new knowledge
- 2 types: deductive and inductive
Deductive Reasoning
- acceptance of a general proposition and the inferences that can be drawn in specific cases
- general observation & specific conclusion
- Exp: poor balance results in falls, exercise improves balance, therefore exercise will reduce risk of falls
Inductive Reasoning
- specific observation & general conclusion
- Exp: patients who exercise don’t fall, patients who don’t exercise fall more often, therefore exercise is associated with improved balance and fewer falls
Reasoning used in research manuscript
- both forms of reasoning (deductive and inductive) are used in research to design studies and interpret data
- Introduction section of research manuscript: deductive logic is used when developing research hypotheses from existing general knowledge
- Discussion section of a research manuscript: inductive reasoning is used when researchers propose generalizations and conclusions from data in a study
What type of reasoning is used in the introduction section of reserach manuscript?
deductive
What type of reasoning is used in the discussion section of a research manuscript?
inductive
Scientific Method
- rigorous process used to acquire new knowledge
- is empirical, systematic, has a control, and has critical examination
2 Assumptions the Scientific Method is based off of
- nature is orderly/regular and events are consistent and predictable
- events/conditions are not random and have causes that can be discovered
The Scientific Method is Empirical
- in research refers to direct observation to document data objectively
Scientific Method is Systematic
- the systematic nature of research implies a sense of order
- logical sequence to identify a problem, collect and analyze data, interpret findings
Scientific Method has a Control
- control of extraneous factors
Scientific Method has Critical Examination
- scrutiny of your findings by other researchers
Scientific Approach is defined as what
- systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena
How to classify research
- based on a number of schema according to PURPOSES And OBJECTIVES
Quantitative Research
- measurement under standardized conditions
- can conduct statistical analysis
- what PTs do
Qualitative research
- understanding through narrative description
- less structured
- interviews
- anthropologists
Basic Reserach
- bench research
- not practical immediately
- may be useful later in developing treatments
Applied Research
- solving immediate practical problems
- most clinical research
Translational research
- scientific findings are applied to clinical issues
- also the generating scientific questions based on clinical issues
- bedside to bench and back to bedside
- collaboration among basic scientists and clinicans
Experimental Research
- researcher manipulates one or more variables and observes
- major purpose is to compare conditions or intervention groups to suggest cause and effect relationships
- RCT is the gold standard of experiemental designs
Quasi-Experimental research
- limited control but can get interpretable results
Non-experimental research
- investigations that are descriptive or exploratory in nature
Exploratory research
- examine a phenomenon of interest including its relationship to other factors
- in epidemiology researchers examine associations to predict risk for disease by conducting cohort and case-control studies
Exploratory Methodological studies
- use correlational methods to examine reliability and validity of measuring instruments
Exploratory Historical research
- studies reconstruct the past on the basis of archives and other records to suggest relationships of historical interest to a discipline
Descriptive Research
- describes individuals to document their characteristics, behaviors, and conditions
- has several designs: descriptive surverys, developmental research, normative studies, qualitative research, case studies
Descriptive Surveys (descriptive research design)
- use questionnaires and interviews to gather data
Developmental research (descriptive research design)
- patterns of growth and change over time in a segment of the population
- natural history of a disease
Normative studies (descriptive research design)
- used to establish normal values for diagnosis and treatment
Qualitative research (descriptive research design)
- interview and observation to characterize human experiences
Case study (descriptive research design)
- or case series
- focus on one individual
Types of Research (9)
- quantitative
- qualitative
- basic
- applied
- translational
- experimental
- Non-experimental
- Exploratory
- Descriptive (has 5 of own types)
Collecting Data
- collect data based on subject’s performance on defined protocol
- surveys
- questionnaires
- secondary analysis of large databases: use data collected for another purpose to explore relationships
5 Major steps of the Research Process
- identify the research question
- design the study
- methods
- data analysis
- communication
Theory
- created because we need to organize and give meaning to complex facts and observations
- interrelated concepts, definitions or propositions that specifies relationships among variables and represents a systematic view of specific phenomena
Scientific theory deals with what
- empirical observation
- requires constant verification
Why use Theory
- to generalize beyond specific situations and to make predictions about what we expect to happen
- provide framework for interpretation of observations
- give meaning to research findings and observations
- stimulate development of new knowledge
- theoretical premise to generate new hypotheses which can be tested
Concepts of Theories
- building blocks of a theory
- allow us to classify empirical observations
- we “label” behaviors, objects, processes that allow us to identify them and refer to/discuss them
- concepts can be non-observable: known as constructs
Constructs
- non-observable concepts of theories
- they are abstract variables (i.e. intelligence)
Propositions
- once concepts are identified they are formed into generalization or proposition
- propositions state relationships between variables
- hierarchial proposition (Maslow’s needs)
- temporal proposition (stages of behavioral change)
Models
- concepts can be highly complex, use models to simplify them
- models are symbolic representations of the elements in a system
- can represent processes (Eg ICF, Nagi models)
How is Development of Theories done?
- by inductive or deductive processes
Inductive Theories
- data based
- begin with empirically verifiable observations
- multiple studies and observations (patterns emerge)
- patterns develop into a systematic conceptual framework which forms basis for generalizations
Deductive Theories
- intuitive approach
- hypothetical-deductive theory is developed with few or no observations (not developed from existing facts; must be tested constantly)
Most theories are formulated using what process? inductive or deductive?
BOTH!
- observations initiate theory and then hypotheses tested
“Testing” Theories
- theories are not testable
- test HYPOTHESES that are deduced from theories
- if a hypothesis is supported, then theory from which it was deduced is also supported
Theory as a foundation for understanding research findings
- results of studies must be explained and interpreted by authors within the realm of theory
- authors must help readers understand context within which results can be understood
- researchers should offer interpretation of findings
- contribute to the growth of knowledge
Researcher’s Integrity
- relevant research question
- meaningful research
- competent investigators
- personal bias in measurement
- misconduct (falsification of data, manipulation of stats)
- publish findings
- authorship
3 Principles of protection of human rights in research
- autonomy
- beneficence
- justice