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83 Cards in this Set

  • Front
  • Back
What are the 3 "Key components" of evidence based health care
1. Clinically relevant questions
2. Systematic review
3. Evidence based conclusions
FDA regulations are established in legislation by __
Congress
Needs FDA pre-approval, takes 7-10 years and requires 3 phases of human trials
New Drug application
__ is used to for generic equivalent drugs
Amended New Drug applicaiton
__-device manufacturere submits evidence of safety for homan testing, then FDA provides __ to begin human trials; process takes __ yrs
Pre-Market Approval
IDE (investigational Device Exemption)
2-4 yrs
__- issued when manufactuer claims new device is "substantially equivalent" to predicate device- takes __ time
510 (k)
90 Days
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
__ come with specific regulated product literature and claims are restricted to clinical evidence
Prescription Drugs
T/F There is very little survailence of OTC drugs and the can make any claims to sell the product
True
When it comes to devices PMA/510 are like prescription drugs and PMA/510 are like OTC
PMA
510
T/F New dental techniques are highly regulated
False
List the Basics of reseach and example questions (hint there are 5 and the 1st one is question)
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
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
TERMS
__-wrong result due to chance-disruption in ANY direction
__wrong reslut due to bias-disruption in ONE direction
Random error
Systematic error
List the steps of focusing a clinical question (4)
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?
List the Parts of a research article
Abstract, Intro, Methods, Results, Discussion, Conclusion
Parts of Research Article
__-synopsis, good for screening
Abstract
Parts of Research Article
__-set up of article, ends w/ statement of purpose
Intro
Parts of Research Article
__-cookbook for reproducing work
Methds and materials
Parts of Research Article
__-data reported, results of statistical tests
Results
Parts of Research Article
__-least important part of research article, explains results and relates study to previous work
Discussion
Give examples of Primary sources
Research articles
Case Studies
Types of Sources
__-"true experiments", control groups, limited scope-external validity
Research articles
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
Give examples of Secondary sources
Review Articles
Meta analysis
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
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
Give some examples of tertiary sources
Text books, manuals, encyclopedias, internet, popular press
__-peer reviewd manuscripts, stringent acceptance crieteira, judged by specialists
"Core" journal
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
Conceptual vs Operational-which is more specific
Operational
__-collect data on a group of subjects at one point in time, observational
Cross-sectional studies
Biggest downfall of cross-sectional studies
Only 1 point in time
__-collect multiple data points on subjects at one point in time
Longitudinal study
Early Failures happen in _ amt of time..list some
Days to months
Postop pain, inappropriate manipulation, inappropriate indication
Late failures happen in __ amt of time...list some
Months to years
Recurrent caries, fatigue failure, excessive wear
List some factors affecting survival rates/failures of restorations (7)
Local/geographic factors, size of cavity, location in arch, type of material, duration of observation, time period, cross-sectional vs longintudinal, study criteral
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
T/F Women are well represented in most drug studies
False
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
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
Sampleing Protocol
__-not a random process
give examples
Non-probablity
Consecutive, convenince, judgmental
Measurement
__-degree to wich a variable when measured several times generated the same value (affected by random errof)
Precision
__-measured values on average are close to true values, affected by systematic error
Accuracy
__-variable represents what it's supposed to represent or measure what it is suppsed to measure
Valitity
__ is affected by random error; __ is affected by systematic error (bias)
Precision
Accuracy
List exampels of systematic sources of error
Subject, examiner and instrument bias
List some examples of random sources of error
Subject, examiner, and instrument variability
__ meastuer the probability that the observed observation is due to chance
Statistical P-test values
P test values less than __ are significant
.05
T/F When using the P test, if a value is non-significant this means that it is not important
False
2 Types of inferentail statistics
1.__-continuous data normally distributed
2.__-categorical data or sometimes non-normally distributed continuous data
Parametric
Non-parametric
Data types
__-measure in a numeric scales that represents a true quantity
__-measured in categories or classes
Continuous
Categorical
2 types of categorical data types
__-categories have no natural order
__-categories have a natural order
Contiuous
Categorical
Frequencies
__-number of observations in each category
__-% total observations in each category
Counts
Proportions
__-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
Measurement of dispersion
__-lgst to smallest
__middle 50%
__-measure of pread around the mean
Range
Inter-quartile range
Standard deviation
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
Types of statistics
__-procedues for summarizing data
___-procedures for drawing conclusions about comparisons, associations or predictions of relationships
Descriptive
Inferential
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
Parametric Normally Distributed exampels
__ and __
t-test
ANOVA
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
__ comares 3 or more means either b/t or w/i groups (often a post-hoc test is used to compare specific groups)
ANOVA
List some examples of non-parametric tests
Wilcoxon sighned, Mann-Whitney U test, Kruskal-Wallis, Chi-Square
Study of distribution of derterinants and antecedents of health and disease in human populations-applications of results to control health problems
Epidemiology
2 Categories of Epidemiology: 1)__-observes disease (time, place, peolpe)
2)__-tests specific hypothesis (relates exposure to disease)
Descriptive

Analytic
Descriptive vs Analytic
Survey and cross-sectional are examples of __
Cohort and case-control are examples of __
Descriptive

Analytic
__ 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
__ 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
__ 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
Cohort
__ study=1 disease, many factors
__ sudy=1 factor, many outcomes
Cases Control

Cohort
"Gold standard "=__-individuals are randomly assigned to a tmt grou, data is analyzed to see if groups are the same then outcomes are evaluated
Radomized Control Trial (RCT)
Alternitive to RCT___-group A gets tmt 1st then Group B then reverse
Cross-over
In pain sudies __% of ppl respond favorable to a placebo; percentage increases when a strong positive suggestion is added by investigator
35%
__ refers to a lack of knowlege about the study tmt
Blinding
__ blinding means either the patient or the investigator doesn't know the tmt, __ means both the patient and investigator don't know
Single blind
Bouble blind
__-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
PPA-practitoner product assessment
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
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
Results
__-proportion of ppl with disease who correctly test positive (true positive/true positive+false negative)
Sensitivity
Results
__-proportion of ppl w/o disease who correctly test negative (true negative/true negative+false positive)
Specificity
__-the proportion of the results that agree with the "gold standard
Diagnostic accuracy
List the steps in EBD
Question, Search, Evaluate, Script, Present, Plan