Exam 1 Review Flashcards
Describe the purpose of clinical research.
INFORM clinical judgements as well as organization and economics of practice
ENGAGE in collaboration and interprofessional efforts
CONTRIBUTE to scientific thought and discovery
Quantitative or qualitative?
Based on numerical data
Quantitative
Quantitative or Qualitative?
Measured w/ subjective, narrative info
Qualitative
Quantitative or Qualitative?
Based on experience
Qualitative
Quantitative or Qualitative?
Logical positivism
Quantitative
Quantitative or Qualitative?
Subjective information that is put on an objective scale
Quantitative
Quantitative or Qualitative?
Social constructivism
Qualitative
5 steps of research process
Identify the research question
Design/plan the study
Implement the study
Analyze the data
Disseminate findings
What is the role of evidence in clinical decision making
Provision of quality care depends on the ability to make decisions based in the best evidence available experience
components of the International Classification of Functioning, Disability and Health
body functions, body structures, activities, participation, environmental factors, personal factors
Function and disability of the ICF
body functions, structures, activates, participation
Activities and participation are based on
capacity and performance
Environmental and personal factors are
contextual factors
role of interprofessional research
For members of multiple professions to work together and make decisions
Explanatory research
compares 2 or more conditions/interventions addressing efficacy and effectiveness
intervention and placebo w/ cause and effect conclusions
RCT
focus on real-world outcomes for quality of life, cost, and implementation
Pragmatic clinical trial
compare group and no control group
Quasi-experimental design
more subjects w/ repeated measurements
Single-subject designs
observational, used to examine a phenomenon of interest
Exploratory research
groups followed prospectively for observational research and outcomes
Cohort studies
compare patients w/ and w/o disorder or outcome of interests
Case-control studies
can be used as basis for decision-making, diagnosis, prognosis, and preventions
Correlational/predictive studies
correlation and comparative methods for reliability and validity instruments
Methodological studies
describing a group w/ questionnaires, interviews, direct observation, and/or databases
Descriptive research
Research that changes over time
Developmental research
Research that serves as guidelines for diagnosis and treatment planning
Normative research
documents condition and intervention effect
Case reports/case studies
reconstructs past to inform contemporary perspectives
Historical research
observation of experience
Qualitative research
combo of quantitative and qualitative methods
Mixed method research
The direct application of scientific discoveries into clinical practice
“Bench to bedside”
Translational research
Proof of the concept
Uses RCT to study efficacy of new therapy and comparing it to placebo or standard care
Used in ideal conditions
Efficacy
Real-world conditions
Inclusion and exclusion criteria is more lax = more comorbidities
Uses PTC to consider function and quality of life for pt satisfaction
Effectiveness
“gold standard”, intervention group and placebo in controlled environment
Limited to where research is being done
Higher exclusion
RCT
hypothesis and study design formulated based on the information needed to make a clinical decision
Study involved in routine practice (primary care settings)
Higher inclusion
PTC
Multidirectional integration of basic research, patient-oriented research, population-based research, with LTG to improve public health
Can be viewed as new drugs, treatments, interventions or the focus of research findings being implemented into practice
Translational continuum
Phases of translational research
T0 = basic research
T1 = translation to humans
T2 = translation to patients
T3 = translation to practice
T4 = translation to populations
generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent diagnose, treat, an monitor/improve delivery of care
Comparative effectiveness research
Advantage of comparative effectiveness research
New research
Limitation of Comparative effectiveness research
It simply may not work
come directly from pt and can be tested across multiple populations; strong correlation to function
Setting: pragmatic or RCT
Goal: pt engagement in outcome measures
Patient-reported outcome measures
outcomes that measure things that a pt would care about: symptoms, quality of life, func, $$$, length of stay
Patient-oriented evidence that matters
the purpose of implementation studies
With new occurring evidence due to efficacy and effectiveness studies they will accumulate and must be implemented
Implementation studies address
clinical performance audits
use of patient/provider alerts to remind them of guideline’s, influence of leaders in practice, problem management, and patient education intervention
Describe the process of developing a research question.
Identify the research problem
Identify the rationale
Identify the type of research
Discuss the sources of research questions.
Clinical experience
Clinical theory
Professional literature: gaps, conflicts, replication
Describe how a theoretical rationale forms the framework for a research question.
Based on generalization from existing studies
How should interventions work and how should the variables be related
IV
Interventions
DV
Outcomes
Describe the purpose of operational definitions.
Variables that are defined to explain how they will be used in a study
Describe the characteristics of good research hypotheses.
Declarative and predict relationship b/ w the IV and DV
Provides evidence so that the hypothesis may be accepted or rejected
Research problem
What you’re researching
Reserach question
PICO
Specific aims
Expanding the studies hypothesis
Research hypothesis
What you’re thinking will happen within research
Discuss the role of theory in clinical practice and research.
Used to generalize beyond a specific situation and to make prediction about what should happen
Identify four purposes of theories in clinical research.
Summarize existing knowledge
Predict what should occur
Stimulate development of new knowledge
Provide basis for asking a question in applied research
acceptance of a general proposition/premise and the subsequent inferences that can be drawn in specific areas
Deductive reasoning
Theory developed w/ few or no prior observations, and often requires the generation of new concepts to provide adequate explanation.
Hypothetical-deductive theory
developing generalizations from specific observations. It begins w/ experience and results in conclusions or generalizations that are probably true
Inductive reasoning
data based and evolve through a process of inductive reasoning w/ empirically verifiable observations.
Indicative theory
abstractions that allow us to clarify natural phenomena and empirical observations
— Can be assigned values and relationships can be examined
— Essential building blocks of a theory are concepts
Concepts
invented names for abstract variables that cannot be seen directly, latent variables
— Most can be defined as function of many interrelated concepts
Constructs
generalized statements asserting the theoretical linkages between concepts
— Create hypothesis and provide foundation for testing theory
Propositions
simplified approximations of reality
Describe conceptual structure closely to give better understanding of the phenomena
Models
explanation of phenomena
Theories
structural representation of specific concepts that comprise theory
Model
tested to demonstrated whether the premise of the theory hold true in certain circumstances
Hypotheses
derived through empirical testing of hypothesis that are deduced from it and from observation of the phenomenon the theory describes
Validity of theory
the factors that have influenced the need for evidence-based practice (EBP) in your profession
To improve clinical decision making
sources of knowledge and how they relate to the use of evidence in practice.
Adaptation of quality research into relevant priorities, including the creation and application of knowledge
Relates to long-standing problem of underutilization of evidence; may take years to implement evidence into practice
use of best research evidence in conjunction w/ clinical expertise, patient values, and clinical circumstances, to inform clinical decisions
EBP
the five steps in the EBP process
Ask the clinical question: PICO
Acquire relevant literature: synthesized evidence
Appraise the literature
Apply the evidence
Assess effectiveness of evidence
PICO format
P — population or problem
I — intervention w/ exposure or test
C — comparison if relevant
O — outcome
Describe the general questions used to critically appraise a study.
Is the study valid?
Are the results meaningful?
Are the results relevant to my patient?
Describe the levels of evidence used to distinguish the strength of studies for quantitative and qualitative studies
Level 1 — systematic reviews
Level 2 — RCTs, observational studies w/ strong designs
Level 3 — study designs w/ poor control of bias, such as retrospective cohorts
Level 4 — descriptive studies: case series
— QUANTITATIVE AND QUALITATIVE
Level 5 — mechanistic reasoning
involves adaptation of quality research into relevant priorities
Creation and application of knowledge
May take years to implement evidence into practice
KNOWLEDGE TRANSLATION
search engines and databases for locating research literature.
MEDLINE, CINAHL, Cochrane Database of Systematic Reviews, OT search, PEDro
Boolean
AND, OR, NOT
— Combing, alternating, excluding terms
MeSH — medical subject headings
Developed by national library of medicine
Provides hierarchy of key terms related to search
Describe several methods for refining or broadening a search
Categories
Broad search = sensitivity
Narrow search = specticity
Selecting identity systematic reviews
provided directly by investigator
Journal articles, research articles, systematic reviews
Primary sources
reviews of studies presented by someone other than the original author
Review articles and textbooks
Secondary sources
established the rules and regulations that govern the conduct of research in the United States
Belmont report — common rule
Autonomy/Respect for persons
there is no lesser
Beneficence
maximize well-being and do no harm
Justice
fairness in research process
— Equity and equality
role of the institutional review board in clinical research
Reviews proposals
Describe the elements of informed consent.
Concise introduction
Purpose of the research
Procedures
Potential risks and discomforts
Potential benefits
Information on study outcomes
Alternatives to participation
Confidentiality
Compensation
Contact information and request for more information
Consent statement
Signatures
Does not require full review
Ex: Surveys, interviews
EXEMPT —> Approved by administration —> APPROVED —> review submitted —> Final report
Does not have potential for harm
Ex: Recording data for subjects
Takes less time
EXPEDITED —> Approved by administration —> APPROVED —> review submitted —> Final report
People
Questionable
FULL REVIEW —> review by full IRB —> Approval deferred —> Revisions submitted —> full review
Define the three main types of misconduct in research.
Fabrication — made up
Falsification — lying
Plagiarism — copying
Explain the purposes of a research proposal.
Critical thinking and scientific literature to ensure the question is refined enough to be studied.
External funding
Details on the project
Application for review by IRB
Enhances communication for colleagues
Detailed account of methods
Describe the components of a research proposal.
Research plan
Administrative support
Describe the important issues for administrative support of a research proposal.
Personnel
Facilities and resources
Budget
anyone involved in research
Personnel
Space and equipment
Facilities and resources
direct and indirect costs
Budget
Cost associated with carrying out the project, including salaries, equipment, facilities, supplies, and travel.
Direct cost
Cost relate principally to the overhead charged by the sponsoring institution for administrative activities, facility maintenance, and any other support services
Indirect cost
Describe how research personnel may be involved in the development of a research proposal.
Scheduling, support staff, research assistants, other
Biosketch for investigators specific to proposal for all personnel
Brief overview of person — how they lend expertise
