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117 Cards in this Set
- Front
- Back
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abstract and general, concerned w/ generating new theory and gaining new knowledge for the knowledge's sake ex theory development
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pure research
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manipulation of one variable to see its effect on another variable
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experimental research
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performed in the clinical setting where control over variables is quite difficult
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clinical
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designed to answer a question to help peoople do their jobs better ex: time use studies
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applied
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describing a group, a situation, or individual to gain knowledge that may be applied to further groups or situations ex: surveys, qualitative research
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descriptive research
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performed in lab surroundings that are tightly controlled ex: basic science research
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laboratory
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_____________ is the summarizing of the information (medical information) and it comes as a systematic review, overview, meta analyses, or decision analysis
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Integrative literature
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___________is based on expanding/extracting evidence from the lit into practice
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Evidence Based Medicine
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_____________ is the keystone to understanding research
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Integrating the literature
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_________ is at the heart of what you do
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patient care
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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) |
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____ 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
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EBM
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The ultimate (and last) consideration in the interpretation of EB literature is the ____________
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LEVEL of EVIDENCE
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____________can be a guide for clinicians about the strength of evidence and its source
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Rating of evidence
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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 |
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Level of evidence modifiers
__Nonrandomized __Systematic review of nonrandomized __lower qual of randomized __clinical cohort __case conttrol __retrospective __uncontrolled __epidemiological |
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2 3 4 5 6 7 8 |
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The intent of _____ is usual evidence-based results in a concise and easily readable format that have a application in clinical practice
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POEM
(Paitent Oriented Evidence that Matters) |
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Provides a systematic process for uncovering answers to clinical and other questions
Expands upon current knowledge Must have a replicatable plan of attack |
research
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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
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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 |
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going from broad to specific
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problem statement, question, aim/purpose, objectives
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____________identifies and discusses published info in a particular subject (knitting together theories for the big picture
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Literature review
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By conducting a RL, you gain skills in ___________and_________
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seeking info
critical analysis |
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a successfu literature review will do the following:
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overview
synthesize controversy questions tools |
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types of indexes available for magazines and journals (2)
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multisubject
subject specific |
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used to expand your search for keywords and concepts
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boolean operators
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research project's methods should be driven by the _____
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objective
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___________ is the researchers expectation for the outcome or solution to the problem…a hunch
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Research hypotheses
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INCLUDES:
Subjects, instrumentation, procedures (for data collection), analytic procedures for evaluating and summarizing the data |
methodology
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____________ is essential, since they can contaminate an experiment or study
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Controlling bias
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____________= 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 |
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___________=consistency with which a measurement is taken
______________=usefulness or appropriateness of the data being gathered…appropriateness of a given measurement |
Reliability
Validity |
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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 |
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Reliability
The two P rule: |
protocol and practice
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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 |
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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 |
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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 |
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threats to internal validity:
___________(History, maturation, or attrition) ____________threats (testing, instrumentation, sampling) |
Temporal (time based)
measurement |
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__________- 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 |
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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 |
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threats related to the populations used or those related to the enviornment of the study
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threats to external validity
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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 |
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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 |
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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 |
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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 |
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_________– those who don’t have the treatment
Both **__________** studies need control group |
control group
case control and cohort |
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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
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examine already existing data, including chart reviews and case control studies
collected data are usually inexpensive and readily availiable in large quantities |
Retrospective studies
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stats uses in medicine:(3)
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1) describe and summarize info
2 ) Infer or generalize to the pop 3) Statistical test for significant relationships or differences between groups |
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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 |
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experimental designs:
Qual or quan? ___________data? (clinical records) ___________data? (info newly generated) |
Retrospective
Prospective |
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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 |
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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 |
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True ______________- randomization of subjects and control groups
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experimental designs
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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 |
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EXPERIMENTAL DESIGN
R X0 O R X1 O Used when pretest is inapp or unavail |
PostTest Only Control Group Design
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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
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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
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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
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4 PARTS OF PROPOSALS METHODS:
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subjects,
instruments, procedures, statistical tests |
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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 |
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1. subject selection
2. devising instrumentation 3. dev procedures 4. performing the statistical analysis |
common pitfalls in research
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Three factors needed for calculating sample size are:
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1.EFFECT SIZE
2.LEVEL OF SIGNIFICANCE(~.05) 3.STATISTICAL POWER (prob of committing Type II or Beta error - incorrectly accepting null hypothesis) |
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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
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retrospective study
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___________trial is highest level of evidence
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Randomized controlled
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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)
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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 |
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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
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inexpensive, convenient, popular data collection method with a response rate issue
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survey design
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a research study involving patients that attempt to answer ?s about new therapies, current therapies or new ways of using known therapies
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CLINICAL INVESTIGATIONS
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all instruments should be __________
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pilot tested
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PA is most involved in what phase of drug trials?
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Phase IV: post release studies to delineate additional info about risks, benefits, and optimal use
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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 |
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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
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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 |
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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 |
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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
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Case studies may reveal unknown relationships of __________and disease or reveal a new condition
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risk factors
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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
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cross sectional study
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______ is the "conscientious, explicit, and judicious use of current best evidence in making decisions about the care of indiv patients"
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EBM
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3 EBM models
each one has a specific purpose, steps and application |
EB review articles
CAT (critically appraised topics) POEM |
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EB review articles can take 1 of 2 forms:
question from a __________ ________ of the author |
clinical scenario
interest |
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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
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CAT
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CATs evolve from ____________, which genarate clinical questions
usually written as a 1 page summary |
patient encounters
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T/F: CAT is a not a comprehensive review or a synthesis of all that is known
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TRUE
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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 |
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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 |
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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 |
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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 |
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Foreground Model has 4 elements
PICO |
Patient and/or Problem or Pop of interest
Intervention (main) Comparison intervention Outcomes of interest |
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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 |
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Highest level of evidence for primary and secondary sources
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primary: randomized controlled trials
secondary: Cochrane library, DARE |
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Etioloy/harm, diagnosis, therapy and prognosis checklists for ___________ research studies
Systematic review/meta-analysis and guideline checklists for __________ studies |
original
secondary |
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Gold standard in ranking of evidence is the ___________
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Oxford Table
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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 |
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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 |
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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 |
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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 |
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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 |
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_____________ , 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
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The overall quality of a systematic review is dependent on the effectiveness of the “__________” search approach
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systematic
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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 |
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Most common method of gathering info and data in the world
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survey research
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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 |
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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 |
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as the quan and qual of experimental data have inc over time, the pop and usefulness of ________ have dec
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case or case series report
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surveys can be used as the __________ and _________ assessment tools
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pre intervention and post intervention
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___________is a “quest for theory building and discovery”
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lit search
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An elementary step in literature interpretation, is to understand __________used in resarch
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certain terms
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To understand an article in the proper context, ____________is impt
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baseline knowledge
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The process is impt because it adds value and becomes part of our “fund of knowledge”
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SM
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“Only through ____________can answers to questions be found, and the scientific process and the info that results form the process be validated”
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scrutiny, analysis and replication
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___________is a “quest for theory building and discovery”
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lit search
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An elementary step in literature interpretation, is to understand __________used in resarch
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certain terms
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To understand an article in the proper context, ____________is impt
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baseline knowledge
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The process is impt because it adds value and becomes part of our “fund of knowledge”
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SM
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“Only through ____________can answers to questions be found, and the scientific process and the info that results form the process be validated”
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scrutiny, analysis and replication
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