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83 Cards in this Set
- Front
- Back
What are the 3 "Key components" of evidence based health care
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1. Clinically relevant questions
2. Systematic review 3. Evidence based conclusions |
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FDA regulations are established in legislation by __
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Congress
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Needs FDA pre-approval, takes 7-10 years and requires 3 phases of human trials
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New Drug application
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__ is used to for generic equivalent drugs
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Amended New Drug applicaiton
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__-device manufacturere submits evidence of safety for homan testing, then FDA provides __ to begin human trials; process takes __ yrs
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Pre-Market Approval
IDE (investigational Device Exemption) 2-4 yrs |
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__- issued when manufactuer claims new device is "substantially equivalent" to predicate device- takes __ time
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510 (k)
90 Days |
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Classification of devices-give examples
I II III __ don't requre clinical testing prior to marketing |
I-handpieces, paper points, denture cleaners
II-most restorative materials, adhesives, denture base/liners III-implants I and II |
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__ come with specific regulated product literature and claims are restricted to clinical evidence
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Prescription Drugs
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T/F There is very little survailence of OTC drugs and the can make any claims to sell the product
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True
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When it comes to devices PMA/510 are like prescription drugs and PMA/510 are like OTC
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PMA
510 |
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T/F New dental techniques are highly regulated
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False
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List the Basics of reseach and example questions (hint there are 5 and the 1st one is question)
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1. Quesiton-what is the purpose
2. Design-how will collect data 3. Analysis-what does data show 4. Interpretation-what does results mean 5. Extrapolation-apply to real world |
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TERMS
__-degree that conclusions describe what happened in the study __-degree that these conclusions are appropriate when applied outside the study |
Internal validity
External validity |
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TERMS
__-wrong result due to chance-disruption in ANY direction __wrong reslut due to bias-disruption in ONE direction |
Random error
Systematic error |
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List the steps of focusing a clinical question (4)
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1. How would i descirbe a group of pts like mine?
2. What tmt am I considering? 3. What are the tmt alternatives 4.What can I accomplish? |
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List the Parts of a research article
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Abstract, Intro, Methods, Results, Discussion, Conclusion
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Parts of Research Article
__-synopsis, good for screening |
Abstract
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Parts of Research Article
__-set up of article, ends w/ statement of purpose |
Intro
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Parts of Research Article
__-cookbook for reproducing work |
Methds and materials
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Parts of Research Article
__-data reported, results of statistical tests |
Results
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Parts of Research Article
__-least important part of research article, explains results and relates study to previous work |
Discussion
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Give examples of Primary sources
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Research articles
Case Studies |
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Types of Sources
__-"true experiments", control groups, limited scope-external validity |
Research articles
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Types of Sources
__-single subject or small group, reports new tmt effect or unusual case, downfalls: no control group, small sample and subjective |
Case Studies
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Give examples of Secondary sources
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Review Articles
Meta analysis |
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Types of Sources
__-overview for complicated/dense area of study; downfalls: selective, biased, misinterpreted etc; want it to evaluate the quality of literature not just summarize it |
Review Articles
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Types of Sources
__-analyzes the combined results of previously publish studies but results may be incomplete and may not have included all relevant studies |
Meta Analysis
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Give some examples of tertiary sources
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Text books, manuals, encyclopedias, internet, popular press
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__-peer reviewd manuscripts, stringent acceptance crieteira, judged by specialists
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"Core" journal
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Variables
__determined byt the investigator-has atleast 2 values __-what is measured __-not controlled for or randomly assigned, could affect the outcome |
Independant variable
Dependant variable Confounding variable |
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Conceptual vs Operational-which is more specific
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Operational
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__-collect data on a group of subjects at one point in time, observational
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Cross-sectional studies
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Biggest downfall of cross-sectional studies
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Only 1 point in time
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__-collect multiple data points on subjects at one point in time
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Longitudinal study
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Early Failures happen in _ amt of time..list some
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Days to months
Postop pain, inappropriate manipulation, inappropriate indication |
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Late failures happen in __ amt of time...list some
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Months to years
Recurrent caries, fatigue failure, excessive wear |
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List some factors affecting survival rates/failures of restorations (7)
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Local/geographic factors, size of cavity, location in arch, type of material, duration of observation, time period, cross-sectional vs longintudinal, study criteral
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Sampeling
__-large set of ppl (world) to which the resluts will be applied __-subset of ppl available for the study __-subset of accessible population that is available for the study |
Target population
Accessible population Intended population |
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T/F Women are well represented in most drug studies
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False
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Criteria
__-main characteristics of target and accessible population __-meet inclusion criteria but have char. likely to interfere w/ the quality of data or interpretation of findings |
Inclusion
Exclusion |
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Sameling protocol
__-random process to assure each person in accessible pop. has had equal chance of selection-give examples |
Probability
Simple random, systematic, Stratified, Cluster |
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Sampleing Protocol
__-not a random process give examples |
Non-probablity
Consecutive, convenince, judgmental |
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Measurement
__-degree to wich a variable when measured several times generated the same value (affected by random errof) |
Precision
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__-measured values on average are close to true values, affected by systematic error
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Accuracy
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__-variable represents what it's supposed to represent or measure what it is suppsed to measure
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Valitity
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__ is affected by random error; __ is affected by systematic error (bias)
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Precision
Accuracy |
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List exampels of systematic sources of error
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Subject, examiner and instrument bias
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List some examples of random sources of error
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Subject, examiner, and instrument variability
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__ meastuer the probability that the observed observation is due to chance
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Statistical P-test values
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P test values less than __ are significant
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.05
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T/F When using the P test, if a value is non-significant this means that it is not important
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False
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2 Types of inferentail statistics
1.__-continuous data normally distributed 2.__-categorical data or sometimes non-normally distributed continuous data |
Parametric
Non-parametric |
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Data types
__-measure in a numeric scales that represents a true quantity __-measured in categories or classes |
Continuous
Categorical |
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2 types of categorical data types
__-categories have no natural order __-categories have a natural order |
Contiuous
Categorical |
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Frequencies
__-number of observations in each category __-% total observations in each category |
Counts
Proportions |
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__-most frequent observation
__-middle observation-half of the observations are larger and half are smaller __-average __-# observations with divided by # without |
Mode
Median Ratios Mean |
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Measurement of dispersion
__-lgst to smallest __middle 50% __-measure of pread around the mean |
Range
Inter-quartile range Standard deviation |
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Tests of Association
__-measures the relationship /t 2 variables -1 means __ 0 means __ +1 means __ |
Correlation coefficient
-1= strong negative correlation 0= no strong relationship +1= strong positive correlation |
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Types of statistics
__-procedues for summarizing data ___-procedures for drawing conclusions about comparisons, associations or predictions of relationships |
Descriptive
Inferential |
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There are 2 subtypes of categorical data
__-categories have no natural order-ie sex, marital status ___categories have natural order-like our end of semester evalutations (like, dislike) |
Nominal
Ordinal |
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Parametric Normally Distributed exampels
__ and __ |
t-test
ANOVA |
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T-test
__-compares your data to "norms" __-compares 2 independent groups __-compares means from 2 independent observations from 1 group |
One sample t-test
2 sample t-test Paired t-test |
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__ comares 3 or more means either b/t or w/i groups (often a post-hoc test is used to compare specific groups)
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ANOVA
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List some examples of non-parametric tests
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Wilcoxon sighned, Mann-Whitney U test, Kruskal-Wallis, Chi-Square
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Study of distribution of derterinants and antecedents of health and disease in human populations-applications of results to control health problems
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Epidemiology
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2 Categories of Epidemiology: 1)__-observes disease (time, place, peolpe)
2)__-tests specific hypothesis (relates exposure to disease) |
Descriptive
Analytic |
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Descriptive vs Analytic
Survey and cross-sectional are examples of __ Cohort and case-control are examples of __ |
Descriptive
Analytic |
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__ science is described by:
Expericmental, variables controlled, all variables known, easy to reproduce, valid results, meaning for humans unknow, little need to statisticallymanipulate data, equipment intensive |
Labratory Science
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__ Science:
Observational, variables controlled by nature, some variables unknown, replication difficult, results uncertain, meaning of results for human clear, statistical control v. impt, labor intensive |
Field Science
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__ study is good for small groups of ppl where a control group of similar ppl can be assembled-one group with a factor and one group without and otherwise matched
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Cohort
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__ study=1 disease, many factors
__ sudy=1 factor, many outcomes |
Cases Control
Cohort |
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"Gold standard "=__-individuals are randomly assigned to a tmt grou, data is analyzed to see if groups are the same then outcomes are evaluated
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Radomized Control Trial (RCT)
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Alternitive to RCT___-group A gets tmt 1st then Group B then reverse
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Cross-over
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In pain sudies __% of ppl respond favorable to a placebo; percentage increases when a strong positive suggestion is added by investigator
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35%
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__ refers to a lack of knowlege about the study tmt
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Blinding
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__ blinding means either the patient or the investigator doesn't know the tmt, __ means both the patient and investigator don't know
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Single blind
Bouble blind |
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__-post-marketing surveillance studies with the objective to obtain info on: user acceptance of handling properties, clinical performance in general practive, feedback for future product improvement
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PPA-practitoner product assessment
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Participants in a PPA
__-advises and assures scientific approach __-placement and observation __-data mgmt, independant quality assurance __-overall project mgmt and funding |
University professor
General dental practitioners CRO Sponsor |
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Null hypothesis
Type I error-null hypothesis is rejected when its true-2 groups are NOT different but experiment says they are is called a __ Type II error-null hypothesis accepted when its false-2 groups are different but experiment says they are not |
Type I=false positive
Type II=false negative |
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Results
__-proportion of ppl with disease who correctly test positive (true positive/true positive+false negative) |
Sensitivity
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Results
__-proportion of ppl w/o disease who correctly test negative (true negative/true negative+false positive) |
Specificity
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__-the proportion of the results that agree with the "gold standard
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Diagnostic accuracy
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List the steps in EBD
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Question, Search, Evaluate, Script, Present, Plan
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