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Patient-Oriented Research
human subjects and helps improve understanding of diseases and disorders
Epidemiologic and Behavioral Studies
observational and describe patterns of diseases and disability
Qualitative Methods
measurement is based on subjective, narrative information ex. focus groups, interviews, and observations
Quantitative Methods
measurement of outcomes uses numerical data under standardized conditions
Scientific Method
founded on two assumptions, nature is orderly and events/conditions are not random or accidental
The Research Process
Identify research question 2. Design study 3. Implement study 4. Analyze datas 5. Disseminate ( share) findings
Evidence-Based Practice
quality care chosen depending on based on current evidence, clinical expertise, patient values, and clinical circumstances
translational research
Application of basic scientific findings to clinically relevant
issues, focuses on efficacy and effectiveness
Models of Health and Disability
model to describe how peoples life with their health conditions
Intraprofessional Research
Members of one profession working together and sharing info from one perspective
Multiprofessional Research
Multiple professions work in parallel to provide input, each stay in professional boundaries
Interprofessional Research
Multiple professions work together and contribute various skills to integrate info
Transprofessional Research
High level of cooperation between multiple professions, blur boundaries and share skills
Applied Research
can be viewed along a continuum
• Classified as descriptive, exploratory, or explanatory
• 3 classifications indicate research purpose
• Different types of research can overlap
• Not a hierarchy
Randomized Control Trial (RCT)
An efficacy trial involving the controlled comparison of an experimental
intervention and a placebo, sham, or usual care condition. Through
random assignment and restricted subject selection, the design controls
for bias to allow cause-and-effect conclusions
Pragmatic Clinical Trial ( PCT)
An effectiveness trial with a focus on real-world outcomes. Participants
represent the patients that would typically received treatment, and
testing takes place in clinical practice settings. Outcomes focus on
issues of importance to patients and stakeholders, including quality of
life, cost, and implementation
Quasi-Experimental Designs
Comparative designs that do no have a control group or randomization.
Includes time-series designs that allow for repeated measurements over
prolonged periods to document trends
Single-Subject Designs (N-of-1-
trials)
Systematic study of one or more subjects with repeated measurements
under controlled and experimental conditions to show changes in
responses with and without intervention, or comparing more than one
intervention
Cohort Studies
observational studies where one or more cohorts are followed prospectively to determine their status with respect to a disease or outcome and their exposure to certain risk factors
Case-Control Studies
observational studies that compare patients with (cases) and without (controls) a disorder or outcome of interest. They help identify risk factors by looking back at exposure history of both groups.
Correlational/Predictive Studies
explore relationships and can be used for decisions making, diagnosis, prognosis, and prevention
Methodological Studies
use correlational and comparative methods to demo reliability and validity of measuring instruments, including interpretation of change and responsiveness
developmental research
investigation of patterns of growth and change over time; may
chronicle natural history of a disease or disability
Normative Research
Establishes normal values for specific variables; serves as guidelines
for diagnosis and treatment planning
Case Report/Case Series
Description of one or several patients or communities to document
unusual conditions or the effect of innovative interventions
Historical Research
Reconstructs the past to generate questions or suggest relationships
of historical interest to inform contemporary perspectives
Mixed Methods Research
both qualitative and quantitative research methods
EBP Process
ask clinical question, acquire relevant research, appraise literature, apply evidence, assess effectiveness of evidence
Appraisal Process ( Clinical Appraisal)
Finding a study revelant to your clinical question, read abstract, read full text
Core Questions- Meaningfulness
what were the outcomes, how are the results interpreted?
Core Questions- Application to Patients
are the findings useful?
NNT
number needed to treat
NNH
number needed to harm
Critically Appraised Topic (CAT)
a brief summary of a search and critical appraisal related to a clinical question
Measurement
he process of assigning numerals to variables to represent quantities of
characteristics according to certain rules
Precision
exactness of a measure
Levels of Measurement
Nominal, ordinal, interval ratio
Nominal Scale
lowest level of measurement, no relative order ex. numbers, letters or words can be used as a category label ( arithmetic properties: counting)
Ordinal Scale
numbers ranked in order, intervals inconsistent or not known ex. manual muscle test, function, pain ( Arithmetic properties: counts, percentages)
Interval Scale
Numbers indicate rank order and demo equal intervals ex. temp, calendar years ( arithmetic properties; addition and subtraction)
Ratio Scale
Highest level of measurement, numbers indicate equal intervals and have a true zero, negative values are not possible ex. age, height, weight ( arithmetic properties: addition, subtraction, multiplication, and division)
HeLa Cells
named after Henrietta Lacks who’s cells were used for research without her knowing
National Research Act
Signed into law by Nixon in response to the misconduct in the Tuskegee syphilis study, requires research to be review by IRB
Belmont Report
focuses on institutional guidelines, informed consent, and review of proposals for the protection of particpants
The 3 Guiding Principles by the belmont report
Respect for persons, beneficence, justice
Respect for persons
personal autonomy, respect human dignity, diminished autonomy must be protected
Beneficence
maximize possible benefits and minimize possible harm, requires that an investigation be justified when studying a treatment to determine its benefits despite known risks
Justice
fairness of the research process
Institutional Review Board (IRB)
full board, expedited , exempt
Consent Elements
voluntary, considerations for special populations, free to withdraw whenever
Full Board
reviewed by convened IRB committee, greater than minimal risk
Expedited
minimal risk, reviewed by IRB chair or designee
Exempt
not greater than minimal risk, reviewed by IRB chair, designee, or staff
Reearch Misconduct
fabrication, falsification, plagiarism
Fabrication
making up data or results and recording or reporting them
Falsification
manipulation research materials, equipment or processes
Plagiarism
taking another person’s ideas, process, results or words without giving credit
Replication
one study cannot be final word, if study can be replicated and produce similar findings = the ultimate goal
Appropriate Power
ability to document significant effects is dependent on the size of effect and sample size
Primary Sources
Reports provided directly by the investigator, such as journal articles
Secondary Sources
include reviews of studies presented by someone other than original author
PICO
population, problem, person, intervention, comparison, outcome
Population
larger group which results in research being generalized, cumulative group of people, objects, or events that meet specific criteria
Sample
subgroup of population, serves as a reference group
Sampling Bias
occurs when the individual’s selected for a sample over or underrepresent a population, either conscious or unconscious bias
Levels of Sampling Process
target population - accessible populations - sample
inclusion criteria
Traits targeted to qualify someone as a
subject for a study
exclusions criteria
factors that would prevent someone from being a sunject
Types of Probability Sampling
Simple random, systematic, stratified random, cluster sampling, disproportional
simple random sampling
unbiased, without replacement
systematic sampling
Researcher divides number of components in the available population by
number of components selected
• Sampling Interval: the distance between the selected elements
• Starting point chosen at random
▪ Using least time consuming and most convenient
▪ Generally considered equivalent to random sampling
1
Stratified Random Sampling
identify characteristics by accessible populations by separating into non-overlapping subsets, proportional
Cluster Sampling
involves successive random sampling in stages
Disproportional Sampling
selecting random samples of adequate size from adequate size from each category
Types of Nonprobabilty Sampling
convenience, quota, purposive, snowball
convenience sampling
cannot generalize, subjects are chosen based on availibility
Quota Sampling
incorporates parts of stratification
Purposive sampling
researcher picks specific subjects based on specific criteria
snowball sampling
used to study sensitive topics, rare traits, personal networks, or social relationships, carried out in stages
systematic measurement error
predictable errors, occurring in one direction, constant and biased
random measurement error
errors due to chance, unpredictable and can be different from trial to trial
generalization theory
not all erors is random, can be attributed to the rater or test occasion
Relative reliability
reflects true variance as a proportion of total variance in a set of scores, unitless coefficient
Absolute reliability
indicates how much of a measured value, expressed in the original units, is likely due to error
Reliability coefficients
can range between 0.00 to 1.00
correlation
association between two sets of data that reflect how consistent the position of the two distribution are
direct agreement
reliability test estimating the ability of researchers to analyze if data is in agreement
Types of Reliability
test-retest, rater, alternate forms, internal consistency
Maximize Reliability
standardize measurement protocols, train raters, calibrate instruments, take multiple measurements, choosing a sample with a range of scores