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meta analyses
pulled info from data creates new data
applied (clinical) research
advances the development of new diagnostic tests, drugs, therapies and prevention strategies, answering questions with direct clinical application
clinical research includes …
patient oriented research
epidemiologic and behavioral studies
outcomes research and health sciences research
patient oriented research
Studies conducted with human subjects to improve our understanding of the mechanisms of diseases and disorders, and of which therapeutic interventions will be most effective in treating them.
control
allows researcher to understand how one phenomenon relates to another
step 1 of research process
identify the research question: formulate a specific question
Step 3 of research process
implement the study: plans from step 1 and 2 are implicated
step 4 of research process
analyze the data: collate the info into useful form of analysis
step 5 of research process
disseminate findings: share findings with appropriate audience so others can apply info
Efficacy
refers to the performance of an intervention under ideal and controlled conditions. It typically involves an RCT with strict protocols and criteria to minimize bias
(effectiveness of intervention under ideal, controlled conditions)
effectiveness
benefits and use of procedures under real world conditions in which circumstances cannot be controlled within an experimental setting
International Classification of Functioning Disability and Health
describe how people live with their health condition, shifting the focus to quality of life.
intraprofessional
members of one profession work together, sharing info through the lens of their own profession
multiprofessional
an additive process whereby members of multiple professions work in parallel alongside each other to provide input, staying within their own professinal boundaries, working seperately ondistinct aspects of the problem
interprofessional
members of multiple professions work together contributing their various skills in an integrative fashion sharing perspectives to inform decision making
transprofessional
a high level cooperation of professionals from multiple fields who understand each others roles and perspectives, share skilles and expertise, and use them to develop new ways of building a problem
scoping reviews
includes a review of literature but with a broader focus on a topic of interest to provide direction for future research and policy considerations.
systematic reviews
all research in an area on a particular topic
Basic Research
directed knowledge torward the acquisition of new knowledge
Epidemiologic and behavioral studies
observational studies focused on describing patterns of disease and disability, as well as on identifying preventive and risk factors
Outcomes research and health services research
studies to determine the impact of research on population health and utilization of evidence-based therapeutic interventions
qualitative research
strives to capture naturally occuring phenomena following a tradition of social constructivism (individual experience)
quantitative research
based on a philosophy of logical positivism in which human experience is assumed to be based on logical and controlled relationships among defined variables (does x effect y)
scientific method
a systematic, empirical, and controlled critical examination of hypothetical propositions about the associations among natural phenomena
systematic
logical sequence that leads from identification of a problem through the organized collection and objective analysis of data
empirical
necessity for documenting objective data through direct observation, minimizing bias
critical examination
researcher must subject findings to empirical testing and to the srutiny of others
step 2 of research process
design the study: plans method of implication
evidence based care
the fundamental principle that the provision of quality care will depend on our ability to make choices that are based on the best evidence currently available
multiple perspectives of evidence based care
research evidence
clinical expertise
patient values
clinical circumstances
translational research
application of basic scientific findings to clinically relevant issues and simultaneously the generation of scientific questions based on clinical dilemmas
Functioning and disability
relationship among health conditions, body functions and structures, activities, and participation
explanatory research
experiemental design (cause and effect) x effecting y
exploratory research
observational (find relationships)
descriptive research
qualitative (describe populations)
Developing a research question step 2
identify the rationale
Developing a research question step 4
define the research question
Developing a research question step 5
state the research question
descripitive
seeking to characterize clinical phenomena or existing conditions in a particular population
comparison
two or more conditions are compared, independent variable
Developing a research question step 1
identify the problem
Developing a research question step 3
identify the type of research
professional literature (1)
Identifying gaps, conflicts, or areas where replication of studies is needed
developing the rationale (2)
review the literature by starting with systematic review or meta analysis and establish a theoretical framework from existing studies
types of clinical research
Explanatory
Exploratory
Descriptive
Methodological
explanatory
cause and effect
exploratory
looking for relationships to determine how clinical phenomena interact
methodological
the process of designing and organizing research methods that have ethical implications.
framing the research question
population or problem
intervention
comparison or control
outcomes
population
what types of patients
intervention
treatment of interest
outcomes
effect of intervention, dependent variable
operational definition
defines a variable according to its unique meaning within a study
characteristics of a good research question
importance
ethical
feasible
clinical experience (1)
clinicians knowledge, experience, and curiosity will influence the types of questions that are of interest
clinical theory (1)
clinicians will often examine theories that govern their practice as a source of research questions
hypothesis
declarative statement that predicts the relationship between the independent and dependent variables
research hypothesis
the researchers true expectation of results, guiding the interpretation of outcomes and conclusions
null hypothesis
no difference or no relationship between the independent and dependent variables
nondirectional hypothesis
do not predict a direction of change
directional hypothesis
not only describe the relationship between variables in terms of a difference, but assign a direction to that difference
simple hypothesis
includes one independent variable and one dependent variable
complex hypothesis
more than one independent or dependent variable
translational research
- refers to the direct application of scientific discoveries into clinical practice
- taking knowledge from bench to bedside
knowledge translation
- a process of identifying clinical problems and accelerating the application of knowledge to imrpove outcomes and change the provision of care
- problems as a clinician and looking for a solution
efficacy
ideal conditions
effectiveness
real world conditions
Randomized Controlled Trial (RCT)
gold standard design to study the efficacy
not the most realistic, results we get are becasue of intervention
pragmatic clinical trial
incorporate measures of function or quality of life that are considered more relevant for patient satisfaction
not randomized, trying to see what happened
explanatory (experimental) trials consists of
controlled design
exclusion criteria
smaller samples
controlled environment
focused outcomes
Pragmatic Trials
flexible design
heterogeneous samples
large samples
diverse practice settings
meaningful outcomes
T0 phase
basic research
focus on theory and mechanisms
T1 phase
Translation to humans
does it work?
T2 phase
translation to patients
can it work under ideal conditions?
T3 phase
translation to practice
will it work in real world conditions?
T4 phase
translating to populations
is it worth it?
comparative effectiveness research
The generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve delivery of care.
pragmatic clinical trials
hypothesis and study design are formulated based on information needed to make a clinical decision
practice based evidence
describe an approach to research that is of high quality but developed and implemented in real world settings
outcomes research
umbrella term to describe studies that forcus on the impact of results of health care practices and interventions
have the practices and interventions changed are people using the knee brace
patient oriented evidence that matters (POEM)
refers to outcomes that measure things that a patient would care about like symptoms, quality of life, function, cost of care, length of stay
primary outcome
used to arrive at a decision on the overall result of the study and that represents the greatest therapeutic benefit
secondary outcomes
endpoint measures that mey also be used to assess the effectiveness of the intervention, as well as side effects, costs, or other outcomes of interest
implementation science
- next step after effectiveness research
- how to put research into practice
- considers the patient, provider, organizational systems, and policy
theory
used to generalize beyond a specific
situation and to make predictions about what should happen in other situations.
allows us to speculate on how and why things work
purpose of theories
- summarize existing knowledge to explain observational events
- allow us to predict what should occur
- development of knew knowledge
- provide the basis for asking a question in applied research
components of theories
- concepts
- contructs
- prepositions
concepts
abstractions that allow us to classify natural phenomena and empirical observations
think variables, height and weight
constructs
abstract concepts that are not obervable (latent traits)
things we cant see but give a definition
stress= cortisol levels
propositions
generalized statements that assert the theoretical linkages between concepts
deductive reasoning
the acceptance of a general proposition and subsequent inferences that can be drawn
broad to specific
inductive reasoning
logic that develops generalization from specific observations
specific to broad
theory
- can never be proven
- not directly testable
hypothesis
- tested to demonstrate if the theory holds in certain circumstances
- facts can support or not support hypothesis; if supported, theory is also supported
theories should be:
- rational
- testable
- economical
- relevant
- adaptable
research
- results of studies can be used to build theories
- theories can be used to develop hypotheses for testing in studies
- implicit and explicit relationships to research questions
practice
- theories guide clinical decisions
- treatment outcomes can support theories
middle range theories
form a bridge between theory and empirical observations
grand theories
more comprehensive; tries to explain phenomena at the societal level
darwins theory of evolution
meta-theory
used to reconcile serveral theoretical perspectives
theories to make theories