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117 Cards in this Set

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abstract and general, concerned w/ generating new theory and gaining new knowledge for the knowledge's sake ex theory development
pure research
manipulation of one variable to see its effect on another variable
experimental research
performed in the clinical setting where control over variables is quite difficult
clinical
designed to answer a question to help peoople do their jobs better ex: time use studies
applied
describing a group, a situation, or individual to gain knowledge that may be applied to further groups or situations ex: surveys, qualitative research
descriptive research
performed in lab surroundings that are tightly controlled ex: basic science research
laboratory
_____________ is the summarizing of the information (medical information) and it comes as a systematic review, overview, meta analyses, or decision analysis
Integrative literature
___________is based on expanding/extracting evidence from the lit into practice
Evidence Based Medicine
_____________ is the keystone to understanding research
Integrating the literature
_________ is at the heart of what you do
patient care
SM
_______precise statement of what is sought
_______single sentence asks ques related to prob
_______plain of how research was done and knowledge gained
________unequivocal statements of knowledge that was gained
________application of knowledge gained
Problem
Question
Method
Results
Interpretation (conclusions/recommend)
____ is research that should bridge the gap between rigorous research and clinical investigations for the clinician, with the ultimate benefit going to the patient. If “evidence based” it is the guiding light for medical practice
EBM
The ultimate (and last) consideration in the interpretation of EB literature is the ____________
LEVEL of EVIDENCE
____________can be a guide for clinicians about the strength of evidence and its source
Rating of evidence
Levels of evidence
____: high quality evidence that considers all imp outcomes. RAndomized controlled, systematic reviews
____: nonrandomized trials Systematic Reviews, cohort studies, case control studies
____: consensus or expert opinion
A

B

C
Level of evidence modifiers
__Nonrandomized
__Systematic review of nonrandomized
__lower qual of randomized
__clinical cohort
__case conttrol
__retrospective
__uncontrolled
__epidemiological
1
2
3
4
5
6
7
8
The intent of _____ is usual evidence-based results in a concise and easily readable format that have a application in clinical practice
POEM
(Paitent Oriented Evidence that Matters)
Provides a systematic process for uncovering answers to clinical and other questions
Expands upon current knowledge
Must have a replicatable plan of attack
research
situation that begs resolution or needs improvement or an answer
Something warrants examination or study for puproses of more effectiveneess, validation of observ, or providing answers
constitutes a research problem
What is a good research question?
One that can be anwsered using _____________
One that includes the relationship between 2 or more ____________
One that is logical

_____________- 1. Potential impact, 2. justification, 3. feasibility
observable data

varaibles


Sutherland’s criteria
going from broad to specific
problem statement, question, aim/purpose, objectives
____________identifies and discusses published info in a particular subject (knitting together theories for the big picture
Literature review
By conducting a RL, you gain skills in ___________and_________
seeking info
critical analysis
a successfu literature review will do the following:
overview
synthesize
controversy
questions
tools
types of indexes available for magazines and journals (2)
multisubject

subject specific
used to expand your search for keywords and concepts
boolean operators
research project's methods should be driven by the _____
objective
___________ is the researchers expectation for the outcome or solution to the problem…a hunch
Research hypotheses
INCLUDES:
Subjects, instrumentation, procedures (for data collection), analytic procedures for evaluating and summarizing the data
methodology
____________ is essential, since they can contaminate an experiment or study
Controlling bias
____________= True meas + error
________=errors that occur bec of chance or “noise”..small sample sizes are vulnerable to this kind of error
____________= A series of consistent biases affecting a measurement
Observed Measurement

Random

Systematic
___________=consistency with which a measurement is taken
______________=usefulness or appropriateness of the data being gathered…appropriateness of a given measurement
Reliability

Validity
Three forms of reliability
1) ____________-consistency of measurement by an instrument
2)______________-consistency with which an indiv takes measurement
3) _____________ –consistency in measurements between or among more than one individual taking the measurement
instrument reliability

intra-rater reliability

Inter-rater reliability
Reliability
The two P rule:
protocol and practice
forms of test validity
1) __________- Does the meas appear appropriate? Often relying on the opinions of experts
2) ___________-Is the measurement based on theory (constructs)
3) __________- Is the test broad enough to address the scope of the content
4) ___________-How well does the test performs and is it useful when judged agst a standard
face validity
construct validity
content validity
criterion validity
Categories of criterion validity:
4a. ___________– assesses whether and how well a test predicts a specific phenomenon or outcome
Ex…How well does a positive Ober test accurately predict a lumbar disc protrusion?

4b.____________-asks whether the test performs as well as an accepted test
Ex…Used to validate short or noninvasive version of a test..to establish the validity of a urine test as opposed to a serum glucose test to monitor diabetes
Predictive Validity

Concurrent Validity
forms of experimental (design) validity:
___________validity- concerned with limiting or controlling factors and events other than the IV, which may cause changes in the DV
__________validity- concerned with factors that may affect the generalizations of the conclusions drawn from the study
internal

external
threats to internal validity:

___________(History, maturation, or attrition)

____________threats (testing, instrumentation, sampling)
Temporal (time based)

measurement
__________- refers to the effects on the DV that are the result of the passage of time
____________can be thought of as those threats that happen by changes resulting from development
__________-when subj leave, the results may be distorted
History

Maturation

Attrition
Threats to Internal Validity
___________-the type of instrumentation may affect the results
___________- The confounding effect of the selection of subjects for a study according to some bias, whether recognized or not
_____________- The tendency for a group of outliers to move twd the mean bec of the laws of probability
Instrumentation

Sampling Effects

Statistical Regression to the mean
threats related to the populations used or those related to the enviornment of the study
threats to external validity
Threats to external validity
________: subj’s accessibility to the study..can’t gen to pop if subj in sample are diff from pop
___________: Thought of as confounding effects of subjects on the DV
___________is the Description of the variables - can’t replicate if the variables aren’t described accurately
____________- when 2 treat, one may potential the effects or otherwise affect the actions of the other..must understand treatment order
Population related
Subj/Treatmt interaction
Enviornmental Threats
Multiple treatments/test order
Enviornmental Threats to External Validity
___________-increase in productivity caused by being subj knowing they were participating in an experiment
___________- measurement errors caused by the involvement of the researcher in a study …personal attributes such as charisma of the researcher may affect the results
Hawthorne Effect

Rosenthal Effect
Types of Research studies
__________- generate data that are either nonnumerical or numerical
____________= qualitative
____________=quantitative
____________test for:
1) between group difference
2) relationships among variables
3) both differences and relationships
Descriptive studies
Non-numerical
Numerical
Analytic Studies
Analytic Studies
__________(analytic studies) a prospective design in which the researcher controls as many subj, treatment and enviornmental variables as possible…not always possible due to risk to human subjects
___________- based on “snapshot” of subjects at one period..longitudinal approach such as following a group for kids of years
____________- Comparing those who have disease to those who don’t, and comparing the two groups for causal factors
__________- Identify people who have and do not have a particular risk factor then examine the groups over time to identify those who later dev the disease.
True Experiments

Cross Sectional Study

Case Control Design

Cohort Study
_________– those who don’t have the treatment

Both **__________** studies need control group
control group

case control and cohort
data collection planned in advance
credited with having better control of variables

greater possibility of having valid and reliable standardized measurement methods

Disadvantages are cost, diff to extrapolate results

include true experiments and concurrent cohort studies
prospective studies
examine already existing data, including chart reviews and case control studies

collected data are usually inexpensive and readily availiable in large quantities
Retrospective studies
stats uses in medicine:(3)
1) describe and summarize info
2 ) Infer or generalize to the pop
3) Statistical test for significant relationships or differences between groups
types of data:
char. names that have no numerical value ex: male

comparative and can be rank ordered ex: shorter

numerical values b/t units but no actual zero point ex: degrees centigrade and BG

numerical values b/t units, and zero is possible
nominal

ordinal

interval

ratio
experimental designs:
Qual or quan?
___________data? (clinical records)
___________data? (info newly generated)
Retrospective

Prospective
Typical Research Deisgns are classified as
_____________.

Use of Campbell & Stanley’s symbols
R, M, X, Xo, O
Pre-experimental, Experimental and Quasi

R = randomization
M = matched
x = tx
Xo = no tx or control
0 = measurement
Pre-experimental Designs
Weakest of designs, subj to many threats
Characterized by__________, sensitive to temp threats and poor generalizability
__________- X O, typical of survey res, snap shop of a specific time, threat to Iv and Ev
_________- O X O, temporal threats (outgrowing due to dev)
___________.(xo:o).Group recieving treat is compared to group not recieving treat..these groups are non equiv therefore possibly something other than treatment causing result....allows studies of variables that can’t be manipulated by the researcher
lack of control grp

One Shot Case study

One Group Pre Test- Post Test

Static Group Comparison
True ______________- randomization of subjects and control groups
experimental designs
R O1 X0 O2
R O1 X1 O2
Commonly known as **gold standard** due to randomization/controls
Rules out most threats to Iv and Ev
EXPERIMENTAL DESIGN:
PreTest/Post Test Control Group Design
EXPERIMENTAL DESIGN

R X0 O
R X1 O
Used when pretest is inapp or unavail
PostTest Only Control Group Design
EXPERIMENTAL DESIGN

R O1 X0 O2
R O1 X1 O2
R X0 O2
R X1 O2
Groups with and without pre-tests are exposed to one or two treatments and subsequently tested after treatment
It is a combination of the previous two designs
Allows researcher to assess whether an effect occurs because of the pre-test
Disadv, requires twice as many subjects
Solomon Four Group Design
More rigorous than preexperimental, not as rigorous as true experimental designs
Generally, randomization is lacking or multiple measurements make testing effects a potential problem
Quasi Experimantal
QUASI DESIGN
0Xo0: 0X0
similar to pre-test/post-test control group design
Because the groups are not randomized they must be considered nonequivalent
Because the grps are nonequiv the results must be viewed w/caution, preexisting conditions may acct for changes
Nonequivalent Control Group Design
4 PARTS OF PROPOSALS METHODS:
subjects,
instruments,
procedures,
statistical tests
Quasi Experimental
____________Used when the investigators suspect that the pretest will signif bias the post-test results
It addresses concerns about the pre-test biasing the outcome
Learning can happen as a result of pretest
0X? : ?X0
______________Groups are compared to each other and there are multiple tests.
Threats to validity of repeated testing and nonequiv groups
Because there are multiple measurements, one can’t conclude that chgs or differences are not a result of sensitization or learning
0Xo000 : 0X000
Separate Sample pretest/post test design

Time Series Design
1. subject selection
2. devising instrumentation
3. dev procedures
4. performing the statistical analysis
common pitfalls in research
Three factors needed for calculating sample size are:
1.EFFECT SIZE
2.LEVEL OF SIGNIFICANCE(~.05)
3.STATISTICAL POWER (prob of committing Type II or Beta error - incorrectly accepting null hypothesis)
study in which indiv both with and w/o a dz are identified for their past exposure or nonexposure to a tx, risk factor, or event
retrospective study
___________trial is highest level of evidence
Randomized controlled
Brief description of problem to be addressed
The purpose of the study
Methods (subjects, instruments, procedures, statistical tests)
Be sure to include subject selection, sample size
PROPOSAL (differs from abstract b/c written in current tense)
Prospective
_______= study new treatments,control treat variables, dec variability by selecting subjects based on inclusion/exclusion criteria,
_________=Expense, lack of assurance that sufficent subj numbers can be retained, probs of study duration such as attrition, chg of subj health status etc.
advantages

disadvantages
ADV: inexpensive, can be planned in short time, readily avail. subjects, ethical situations are minimal

Disadv:1. data may be unstandardized or inaccurate
2. diff to verify tx and data collection procedures
3. selection of groups is difficult
4. extraneous variables may not be known
retrospective adv and disadv
inexpensive, convenient, popular data collection method with a response rate issue
survey design
a research study involving patients that attempt to answer ?s about new therapies, current therapies or new ways of using known therapies
CLINICAL INVESTIGATIONS
all instruments should be __________
pilot tested
PA is most involved in what phase of drug trials?
Phase IV: post release studies to delineate additional info about risks, benefits, and optimal use
Types of CI:
_______________: subj assign to treat or control based on chance (randomization)..Can be many experim groups but only one control group. These are the“gold standard” especially when __________..eliminates bias based on knowledge of group assingment..
_________when the drug is known
Randomized Controlled Studies

Blind or double blind

open label
Blinded CCI of a group of people w/ sim char carried out over time; involve observ across time and don't involve intervention
Steps include:
1. ID problem
2. Dev ques and hyp
3. ID Cohort char(age, gender, health/or dz condition, medication need, variables)
4. Define exclusion criteria
5. Define time interval
6. Define end points/markers
7. Define measurement of these end points
cohort studies
Cohort investigations are often descriptive of a __________and its risks and conditions
Often can be _________, identifying risks, and comparing outcomes between and within cohorts.
disease process
analytic
CIs___________: subj based on whether or not they have the disease or condition you are studying
Emphasis on identification of the prevalence or exposure to known or suspected risk factors

Controls are people______the disease or condition you are studying
They are typically ___________and common in epidemiologic studies
Ultimate outcome is to define the odds ratio for the risk factors for development of a condition or disease….ad/bc
Case Controlled Studies

without

retrospective
involves the description of one or more patients with unusual presentations of conditions…or outcomes from innovative interventions;
require more detailed intensive exams
Case Series Studies
Case studies may reveal unknown relationships of __________and disease or reveal a new condition
risk factors
a form of the cohort study, and sometimes a case series, it is a retrosp. Study. Can also be one of time intervention. Involves stratification of sample, conditions set by investigator
cross sectional study
______ is the "conscientious, explicit, and judicious use of current best evidence in making decisions about the care of indiv patients"
EBM
3 EBM models

each one has a specific purpose, steps and application
EB review articles
CAT (critically appraised topics)
POEM
EB review articles can take 1 of 2 forms:
question from a __________
________ of the author
clinical scenario

interest
a single piece of evidence that is summarized and should NOT be considered complete or representative of the entire body of evidence on a clinical issue
CAT
CATs evolve from ____________, which genarate clinical questions

usually written as a 1 page summary
patient encounters
T/F: CAT is a not a comprehensive review or a synthesis of all that is known
TRUE
Outline of a CAT

_________-gives a declarative answer to your question

_________-describes how this evidence is used in clinical care

_________-summary of patient case
title

clinical bottom line

clinical scenario
summaries of valid research, focused on primary care issues impacting practice

the concept of "_____________" stresses that the evidence must matter to clinician and patient
POEM (patient oriented evidence that matters)

Information Mastery
3 questions you need to ask to determine if a study qualifies to be a POEM:
Did the research focus on an __________ that pts care about?
Is the problem studied _________ and is the intervention feasible?
Does the info have the potential to change the practice of many clinicians?

website & published in the Journal of Family Practice
outcome

common
EBM Step 1: topic/question

_________-general knowledge about a disorder (who, what, when, how)

_________-specific knowledge about how to diagnose, treat, or predict outcome
Background

Foreground
Foreground Model has 4 elements
PICO
Patient and/or Problem or Pop of interest
Intervention (main)
Comparison intervention
Outcomes of interest
What type of question:
______-double blind randomized controlled trial
______-controlled trial
______-cohort studies, case control, case series
______-cohort studies
______-randomized controlled trial, cohort studies
Therapy
Diagnosis
Prognosis
Etiology/HARM
Prevention
Highest level of evidence for primary and secondary sources
primary: randomized controlled trials

secondary: Cochrane library, DARE
Etioloy/harm, diagnosis, therapy and prognosis checklists for ___________ research studies

Systematic review/meta-analysis and guideline checklists for __________ studies
original

secondary
Gold standard in ranking of evidence is the ___________
Oxford Table
3 main areas in which data can be effectively pooled and sorted:
description of ____________ (or conduct) of each study
_________ assessment information
________ presented in a way that allows the investigations of trends
characteristics

validity

results
The purpose of CLINICAL REVIEW is to
1)“improve the ___________of practicing clinicians”
2)“ improve the overall ___________of how medical care delivered by summarizing what is KNOWN about a disease entity”.
knowledge and understanding

quality
Four Categories of Clinical Reviews:

Remember. Each review differs in the degree to which the source info is grounded in the literature.
1. A general review of a clinical topic
2. A summative review of a clinical topic
3. A systematic review of the literatures (on a specific topic)
4. The case or case series report
The General Clinical Review
AKA “____________” bec. purpose is to bring the reader’s practice knowledge and skills up to date in the topic area
Careful- clinical reviews used in practice recommendations; pay careful attention to “_________” accuracy, make efforts to avoid personal bias
update articles

factual
Difference from GENERAL review is that the TOPIC area is __________w/more
effort made to review the existing literature more thoroughly than with the general clinical review; CHAR AS MORE __________
SUMMATIVE REVIEW ARTICLES

narrower

qualitative
_____________ , a type of EBM, are concise summaries of the best available evidence, designed to address carefully defined clinical questions.;
Journals and internet sites, dedicated to EMB, offer
Systematic Review
The overall quality of a systematic review is dependent on the effectiveness of the “__________” search approach
systematic
Skills you need to have for Summative and Systematic Reviews
1) The ability to search med literature…good info searching skills
2) __________to “deconstruct and critique” research articles…must understand the research process for this, as well as identification and understanding of problems and limitations from studies
3) Understanding of _____
________and statistical and data manipulation skills…
Critical skills

basic statistics
Most common method of gathering info and data in the world
survey research
Survey Research
What can Surveys do? (Advantages)
Gather various types of info
By various modalities..mail, internet, person, phone
Collection of _________or both kinds
Sample subj can be predefined by ____________
Samples can be randomized or assigned, stratified, etc….
Done __________,______,______
quant, qual

characteristics

easily, inexpensive, and fast
Survey Research
What surveys CAN’T Do?
Can’t establish ________..no manip of variables
Can be used are pre and post intervention assessment tool
___________is questionable with self report
Reliability is challenged by respondent bias, nonrepondent influence, and interpretation of items
Good design/item construction should help limit the influence on ________.
causality

Reliability

outcomes
as the quan and qual of experimental data have inc over time, the pop and usefulness of ________ have dec
case or case series report
surveys can be used as the __________ and _________ assessment tools
pre intervention and post intervention
___________is a “quest for theory building and discovery”
lit search
An elementary step in literature interpretation, is to understand __________used in resarch
certain terms
To understand an article in the proper context, ____________is impt
baseline knowledge
The process is impt because it adds value and becomes part of our “fund of knowledge”
SM
“Only through ____________can answers to questions be found, and the scientific process and the info that results form the process be validated”
scrutiny, analysis and replication
___________is a “quest for theory building and discovery”
lit search
An elementary step in literature interpretation, is to understand __________used in resarch
certain terms
To understand an article in the proper context, ____________is impt
baseline knowledge
The process is impt because it adds value and becomes part of our “fund of knowledge”
SM
“Only through ____________can answers to questions be found, and the scientific process and the info that results form the process be validated”
scrutiny, analysis and replication