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58 Cards in this Set

  • Front
  • Back
Research in the PA Profession
improving patient care

clinical guidelines

healthcare policies

expanding the scope of PA practice
Changing Trend of PA Program
educating PA students about research methodologies

data collection

critically appraised research findings

More PA faculty are involved in clinical, educational, and workforce research
Kochs Postulates
specific organism must always be observed in assoc with disease

organism must be isolated from an infected host and grown in pure culture in the lab

when organisms from pure culture are inoculated into a susceptible host organism, it must cause the disease

the infectious organism must be re-isolated from the diseased organism and grown in pure culture
The Research Process
1. research idea
2. literature review
3. theoretical formulation of the research problem
4.empirical research question (operationalization)
5. research design (planning)
6.data collection
7. data analysis
8. answering empirical research questions
9. theoretical interpretation of the results
10. comparison with earlier research
11. conclusions
Study Protocol
anatomy and physiology of research
anatomy of research
research question
significance
design
subjects
variables
statistical issues
origins of research questions
build on experience

review existing literature in an area of study

attend national meetings and journal clubs

observation of patients
characteristics of good research question
feasible
interesting
novel and original
ethical
relevant
feasibility
adequate number of subjects

adequate technical expertise

affordable (time and money)
novelty
confirms or refutes previous findings

extends previous findings

provides new findings
relevancy
to scientific knowledge

to clinical and health policy

to future research directions
design types
observational
-cross section
-cohort
-case control

experimental
-randomized trials
-basic science research
epidemiologic prototypes
-cohort study
-cross sectional study
-case control study
-randomized trial
major decisions for subjects
specifying selection criteria

sampling
statistical issues
sampling size estimation

managing and analyzing data
physiology of research
findings in the study -->infer--> truth in the universe
goal
to draw inferences from the study results about the nature of truth in the universe
random error
wrong result due to chance

remedy by increasing sample size
systematic error
wrong result due to bias, or error that occurs consistently with an instrument
internal validity
degree to which the investigator's conclusions correctly describe what actually happened in the study
external validity
degree to which the conclusions are appropriate when applied to the universe outside the study
predictor variable (independent)
presumed cause of the dependent variable
outcome variable (dependent)
presumed effect of an independent variable
confounding variables (intervening of extraneous variables)
phenomena that has an effect on study variables but are not necessarily the objects of the study
cohort studies
involves following groups of subjects over time
cohort study types
prospective studies

retrospective studies
strengths of prospective cohort studies
true estimates of absolute risks may be obtained

many different disease outcomes may be studied

data collection may be controlled by the investigator, so that outcome events may be confirmed
weaknesses of prospective cohort studies
very expensive and inefficient

long wait for results

only risk factors that have been defined and measured in the beginning of the study can be assessed

sometimes affected by confounding variables
steps of prospective cohort design
select sample

measure predictor variables (risk factor present of absent)

follow up cohort

measure outcome variables (disease present of absent)
steps of retrospective cohort design
identify cohort that has been assembled in the past

collect data on predictor variables (measured in the past)

follow up the cohort

collect data on outcome variables (measured in the past or present)
what do cohort studies describe
incidence and relative risk
incidence
proportion of population who get the disease over a period of time
relative risk
ratio of the risk of an outcome in persons with the factor of interest to the risk in those without the factor

(ratio of outcome in exposed subjects/unexposed)
when to use cohort design
incidence and natural Hx of a condition

often the only way to establish the temporal sequence of predictor and outcome variables

cohort studies are the only way to study certain rapidly fatal diseases

permit the investigator to study numerous outcome variables, whereas case controlled is limited to a single outcome

as follow up of a cohort study continues and more events accumulate, a cohort study gains power to study an ever increasing number of health outcomes
cross sectional studies
similar to cohort except all measurements are made at once, no follow up period
what do cross sectional studies study
prevalance of condition/disease
steps for cross sectional design
select sample

measure predictor and outcome variables
strengths of cross sectional study
fairly quick, easy and inexpensive

determine prevalence of risk factors and frequency of prevalent cases of disease for a defined population

assessing current health status of a population

use in infectious disease epidemiology for establishing antibody levels indicative of past exposures and the degree of population immunity
weaknesses of cross sectional study
temporal relationships remain uncertain because data on exposures and outcomes are obtained simultaneously (difficulty of establishing causal relationships)

impractical for the study of rare diseases
prevalence
proportion of population who have a disease at one point in time
statistics for expressing disease frequency in observational studies
prevalence (cross sectional) - number of people who have the disease/number of people at risk

incidence (cohort) - number of new cases of a disease during a period of time/ number of people at risk during a period of time
case control studies
investigator identifies groups of subjects with and without the disease, then looks backward in time to find differences in the predictor variables that may explain why the case got the disease and control did not
case control studies begin with...
begin with sample of Cases and Controls

Start with Disease status, then assess and compare Exposures in cases vs Controls
cross sectional studies begin with...
begin with cross sectional sample

determine Exposure and Disease at same time
cohort studies begin with...
begin with Healthy Cohort

Start with Exposure status, then compare subsequent disease experience in exposed vs unexposed
case control design steps
select sample with the disease (cases)

select sample at risk (controls)

measure predictor variables
strengths of case control studies
quick and inexpensive

useful when the outcome is rare

many risk factors (exposures may be considered)
weaknesses of case control studies
risk of recall bias

difficulty in determining proper control groups

actual risk of outcome cannot be determined but is estimated by odds ratio
what is an odds ratio
calculated by dividing the odds in the treated or exposed group by the odds in the control group.

an odds ratio greater than 1 implies a positive association between the exposure and the condition of interest

odds = probability / 1 - probability
interpreting the odds
odds greater than 1 = event is more likely to happen than not

if odds are less than 1, chances are that the event wont happen
ideal diagnostic tests
positive result in everyone with the disease and neg result in everyone else

quick, safe, simple, painless, reliable and inexpensive

(strep test, preg test, urinalysis etc)
structure of diagnostic tests
straightforward structure, similar to other observational studies
they have
1. predictor variable (test results)
2. outcome variable (presence of absence of the disease)
sensitivity
ability of a test to detect a disease when it is present

TP / TP + FN
specificity
ability of a test to indicate nondisease when no disease is present

TN / TN + FP
randomized controlled clinical trials (RCCT)
used to test therapeutic interventions in ill persons
randomized controlled field trials (RCFT)
used to test preventative interventions in well persons
disadvantages of experimental designs
often costly in time and money

may be ethical barriers

outcomes may be too rare

standardized interventions may be different from common practice (reducing generalizability)

restrict the scope and narrow the study question
advantages of experimental designs
can produce strongest evidence for cause and effect

can be the only possible design for some research questions

sometimes can be faster and cheaper than observational