Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 -...
-
Upload
leo-blankenship -
Category
Documents
-
view
216 -
download
0
description
Transcript of Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 -...
![Page 1: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/1.jpg)
Introductory course on Field EpidemiologyIntroductory course on Field Epidemiology
Prof.Dr.Pirom Kamol - RatanakulProf.Dr.Pirom Kamol - RatanakulJune 27, 2006 09.00 - 12.00 a.mJune 27, 2006 09.00 - 12.00 a.m..
EXPERIMENTALEXPERIMENTALSTUDYSTUDY
![Page 2: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/2.jpg)
RESEARCHRESEARCH
A STUDY IN SEARCH FOR A STUDY IN SEARCH FOR FACTSFACTS
OR OR NEW KNOWLEDGENEW KNOWLEDGE USING THE RELIABLE USING THE RELIABLE
AND VALID METHODOLOGYAND VALID METHODOLOGY
![Page 3: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/3.jpg)
DESIGN METHODOLOGYSTATISTICS
VALIDITY
RESULT ERROR(เท็จ)
True Value(จรงิ)+
RANDOM(NOISE)
SYSTEMATIC(BIAS)
![Page 4: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/4.jpg)
Drug ANOYES
IMPROVEMENT Improvement Rate
Drug B
10 10 20 1020 = 50 %
5 15 20 20 = 25 %5
Drug A LOOKS TWICE AS GOOD
![Page 5: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/5.jpg)
Drug ANOYES
IMPROVEMENT Improvement Rate
Drug B
500 500 1,000 5001,000 = 50 %
Drug A ONLY MARGINALLY BETTER
450 550 1,000 1,000 = 45 %450
BUT x2 = 5.01 AND P < .05
![Page 6: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/6.jpg)
Drug ANOYES
IMPROVEMENT Improvement Rate
Drug B
10 10 20 1020 = 50 %
5 15 20 20 = 25 %5
Drug A LOOKS TWICE AS GOOD
BUT x2 = 2.67 AND P > .05
![Page 7: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/7.jpg)
WEIGHT IN (Lb.)
200
201
202
203
204
205
1 2 3 4 5
DAYS ON TREATMENT
![Page 8: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/8.jpg)
0
30
100
130
200
250
1 2 3 4
DAYS ON TREATMENT
Wt (1b)
SUPPRESS THE ZERO
![Page 9: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/9.jpg)
esearch design
esearch methodology
tatistics
![Page 10: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/10.jpg)
RESEARCHDESIGN
![Page 11: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/11.jpg)
HYPOTHESIS
Expected Relationship between 2 (or more) Variables
CAUSEDETERMINEINFLUENCE
INDEPENDENTVARIABLES
DEPENDENTVARIABLE
CLEAR VALUE-FREE SPECIFICTESTABLE
c AVAILBLE METHODS
![Page 12: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/12.jpg)
INDEPENDENTVARIABLE
DEPENDENTVARIABLE
เหตุExposure
(Risk Factor)
ผลOutcome
INTERVENTION OUTCOME
![Page 13: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/13.jpg)
X - sectional
Cohort(Prospective)
Case-control(Retrospective)
ClinicalResearch
Experimental
Assign Exposure
Natural Exp.
Laboratory
Animal
Human
Descriptive
Analytical
X-sectional
Longitudinal
Observational
NO comparison group
Comparisongroup
![Page 14: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/14.jpg)
O+
(CASE)O-
(CONTROL)
E ORETROSPECTIVEEXPOSURES
E1
E1
E1
.
.
.
![Page 15: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/15.jpg)
EE OOPROSPECTIVEPROSPECTIVE
OOUUTTCCOOMMEESS
OO11
OO22
OO33EE++ PROSPECTIVEPROSPECTIVE
EE-- PROSPECTIVEPROSPECTIVE
COHORTCOHORT
![Page 16: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/16.jpg)
X-SECTIONALX-SECTIONAL
SAMPLESAMPLE
EE OO
PRESENT SITUATIONPRESENT SITUATION
![Page 17: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/17.jpg)
X-XECTX-XECT
RETROSPECTIVERETROSPECTIVECASE-CONTROLCASE-CONTROLE OE O
PROSPECTIVEPROSPECTIVECOHORTCOHORT E OE O
(Natural E)(Natural E)
EXPERIMENTALEXPERIMENTAL E OE O (Assign E)(Assign E)
RETROSPECTIVE PROSPECTIVERETROSPECTIVE PROSPECTIVEE
O
PAST FUTUREPAST FUTURE
PRESENTPRESENT
![Page 18: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/18.jpg)
EE--
EE++
O-
(Control)
O+
(Case)
OUTCOMEOUTCOME
EXPOSUREEXPOSURE
![Page 19: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/19.jpg)
EXPOSUREEXPOSURERISK FACTORSRISK FACTORS
OUTCOMEOUTCOMEEFFECTEFFECT
PastPast Present SituationPresent Situation FutureFuture
Cross - sectionalCross - sectional
Case – ControlCase – Control(Retrospective)(Retrospective)
CohortCohort(Prospective)(Prospective)
![Page 20: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/20.jpg)
ASSIGN EXPOSURE or INTERVENTION ?ASSIGN EXPOSURE or INTERVENTION ?
RETROSPECTIVERETROSPECTIVECASE-CONTROLCASE-CONTROL
PROSPECTIVEPROSPECTIVECOHORTCOHORT
CROSS-CROSS-SECTIONALSECTIONAL
E OE O E OE O E/OE/O
START FROM “O” or “E” ?START FROM “O” or “E” ?
ANALYTICANALYTIC DESCRIPTIVEDESCRIPTIVE
CAMPARISON GROUP ?CAMPARISON GROUP ?YES NOYES NO
OBSERVATIONALOBSERVATIONALEXPERIMENTALEXPERIMENTAL
YESYES NONOOBSERVEOBSERVE
![Page 21: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/21.jpg)
RESEARCH QUESTION (S)
![Page 22: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/22.jpg)
BURDEN OF ILLNESS
EFFICACY
ETIOLOGY ORCAUSATION
EFFECTIVENESS
EFFICIENCYIMPLEMENTATION
ทกุข์
สมุทัย
นิโรธ
มรรค
Natural Hx. Diagnostic test
![Page 23: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/23.jpg)
RESEARCH METHODOLOGY
Population & Sample INTERVENTION Outcome Measurement
TARGET POP.
POPULATIONto be
SAMPLED
Sampling Technique
SAMPLE
N = ?
Allocation
EXPERIMENTIntervention
CONTROLStandard Placebo
OUTCOMEMEASUREMENT
Primary OutcomeSecondary Outcome
1
2
3
![Page 24: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/24.jpg)
BURDENNATURAL HISTORYDIAGNOSTIC TEST
CAUSATIONTHERAPY?
EXISTING DATACRITICAL APPRAISAL
VALIDITY / APPLICABILITY
YES NORESEARCH
![Page 25: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/25.jpg)
ORIGINAL DO IT BETTER
ME TOO !
LEVEL OF SCIENTIFIC WORK
![Page 26: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/26.jpg)
METHODOLOGY & STATISTICS
RESEARCH DESIGN
![Page 27: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/27.jpg)
GOOD QUESTION ?
NO YESREQUIRED RESEARCH ?
YESNORESEARCH DESIGN ?
Pop. Intervention MeasurementRESEARCH METHODOLOGY
STATISTICS ?
![Page 28: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/28.jpg)
WHAT IS A CLINICAL TRIAL?
Assign intervention techniques
Prospective study Follow forward in time From a well-defined pt. (baseline)
Contain a “CONTROL GROUP”
Comparable to the exp.gr. in every wayComparable to the exp.gr. in every wayexcept for the intervention being studiedexcept for the intervention being studied
Randomized assigning subjects to control & exp.gr.
IDEAL CLINICAL TRIAL
RANDOMIZED DOUBLE-BLINDRANDOMIZED DOUBLE-BLINDCLINICAL TRIAL (RCT)CLINICAL TRIAL (RCT)
![Page 29: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/29.jpg)
PHASE OF CLINICAL TRIALSPHASE OF CLINICAL TRIALS
PHASE I :PHASE I :PHASE 2 :PHASE 2 :PHASE 3 :PHASE 3 :PHASE 4 :PHASE 4 :PHASE 5 :PHASE 5 :
First test on humanFirst test on humanLimitted clinical trialLimitted clinical trialLarge scale clinical trialLarge scale clinical trialLarge scale field trialLarge scale field trialSurveillanceSurveillance
![Page 30: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/30.jpg)
SAMPLE
ExperimentalGroup
R
ControlGroup
POST
TEST
Intervention(New Drug)
Standard Rx(Placebo)
- Pretest Posttest Control Group Design Classical or Full Experimental Design
Assignment
PROSPECTIVEPROSPECTIVE
PRE
TEST
![Page 31: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/31.jpg)
SAMPLE
Experimenta1 Group
R
POST
TEST
Posttest - Only Control Group Design
Intervention (New Drug)
Control Group
Standard Rx or Placebo
Assignment
PROSPECTIVE
![Page 32: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/32.jpg)
- BEFORE AFTER STUDY
INTERVEN
TION
SAMPLE
BEFOREBEFOREASSESSMENTASSESSMENT
AFTERAFTERASSESSMENTASSESSMENT
![Page 33: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/33.jpg)
BEFOREBEFORE AFTERAFTER
20%
80%
100
80
60
40
20
0
% K
![Page 34: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/34.jpg)
TIME SERIES DESIGN
SAMPLEO1 O2 O3 O4 O5 O6
INTERVENTIONINTERVENTION
- PRE TEST - POST TEST
TIME
![Page 35: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/35.jpg)
001 1 002 2 003 3 004 4 005 5 0066
INTERVENTIONINTERVENTION
![Page 36: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/36.jpg)
- -Pre test Post test
- - - -Pre test Post test Pre test Post test
OO 1 1 OO 2 2 OO 3 3 OO 4 4 OO 5 5 OO66 INTERVENTIONINTERVENTION
OO 1 1 OO 2 2 OO 3 3 OO 4 4 OO 5 5 OO 6 6
INTERVENTIONINTERVENTION
OO 1 1 OO 2 2 OO 3 3 OO 4 4 OO 5 5 OO66 INTERVENTIONINTERVENTION
![Page 37: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/37.jpg)
CROSS-OVER DESIGN
SAMPLE
S1S1
Carry-overCarry-overEffectEffect
(PLACEBO)(PLACEBO)
Intervention BIntervention B(Drug B)(Drug B)
Intervention AIntervention A(Drug A)(Drug A)
Run inRun inperiodperiod
![Page 38: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/38.jpg)
INTERVENTIONPOPULATION OUTCOME
Experimental Group
Control Group
POPULATION
SampledPopulation
Sampling
SAMPLE R
Allocation
Follow-up
OUTCOMEPrimary
1.)……….2.)……….3.)……….4.)……….5.)……….
secondary
RiskComorbidity
Age ; sex ; etc.
stratabalance
ContaminationCointerventionCompliance
DropoutDuration
RelevantCapableCredibleAccuracyAvailable
Blinding
![Page 39: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/39.jpg)
HEART FAILURE
EXERCISEEXERCISENO EXERCISENO EXERCISE
205070
YES NO8050
130
100100200
Extraneous to the question R.F. of the “outcome” Associated with “exposure” (Not equally distributed)
CONFOUNDING FACTORCONFOUNDING FACTOR
Angina PectorisAngina Pectoris
![Page 40: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/40.jpg)
Restriction inclusion criteria Restriction inclusion criteriaMatchingMatching
Stratified Sampling (Prognostic Stratification) Stratified Sampling (Prognostic Stratification)RandomizationRandomization
-Stratified Analysis (Post stratification) -Stratified Analysis (Post stratification)AAjjustment/Standardizationustment/StandardizationModelingModeling
HOW TO AVOID CONFOUNDING
![Page 41: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/41.jpg)
TARGET POPULATION
POPULATIONto be
SAMPLED
SAMPLING TECHNIQUES
SAMPLE
N = ?
![Page 42: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/42.jpg)
Agent Host Unequilibrium Diseases
Seeking CareSeeking Care
30
20
10
Care Death
HealthHealth
CareCare
SystemSystem
DisabilityDisability
Env.
CureCureDisabilityDisabilityDeathDeath
![Page 43: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/43.jpg)
Restriction inclusion criteria Restriction inclusion criteriaMatchingMatching
Stratified Sampling (Prognostic Stratification) Stratified Sampling (Prognostic Stratification)RandomizationRandomization
-Stratified Analysis (Post stratification) -Stratified Analysis (Post stratification)AAjjustment/Standardizationustment/StandardizationModelingModeling
HOW TO AVOID CONFOUNDING
![Page 44: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/44.jpg)
PROBLEMS OF CLINICAL TRIAL
PATIENT (SUBJECT) VARIATION RACE
GENETIC AGE, SEX, HIEGHT, BODY WEIGHT
PHYSIOLOGY PROCESS BIOCHEMISTRY LEVEL
DISEASE VARIATIONTYPESTAGEDURATION EARLY
LATESEVERITY
CONCOMITANT DISEASE
BIOLOGICAL VARIATION
![Page 45: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/45.jpg)
INCLUSION EXCLUSIONSAMPLE
AgeAge Confounders ConfoundersSexSex Unethical Unethical
Dx. Criteria Dx. Criteria Not feasible Not feasibleDis.SeverityDis.SeverityDis.DurationDis.Duration
Referal Filter Referal Filter
![Page 46: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/46.jpg)
![Page 47: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/47.jpg)
PRIMARY OUTCOME EVENT RATE (CONTROL GROUP)
CLINICAL SIGNIFICANCE TYPE I & TYPE II ERROR
VARIATION OR STAND. DEVIATION
JUSTIFICCATION OF THE SAMPLE SIZE
![Page 48: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/48.jpg)
2 POSSIBLE ERRORS OF INTERPRETATION
CONCLUSION[drawn from
analysiswhen the trialis completed]
TREATMENTBENEFIT
NOTREATMENT
BENEFIT
CORRECT
TYPE II ERROR
TYPE I ERROR
CORRECT
TREATMENTBENEFIT
NO TREATMENTBENEFIT
THE TRUTH
![Page 49: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/49.jpg)
EXPERIMENT GR.INTERVENTION
CONTROL GR STD. Rx.
PLACEBO
OUTCOMES
SUBJECT
ALLOCATION
A
B
STRATA BALANCE?BLIND?
![Page 50: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/50.jpg)
100
![Page 51: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/51.jpg)
100
![Page 52: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/52.jpg)
Each subject has the same chanceEach subject has the same chanceof being assigned to eitherof being assigned to either‘‘Experimental’ or ‘Control Group’Experimental’ or ‘Control Group’
COMPARABILITYCOMPARABILITY
Prognostic factors (Baseline characteristics)Prognostic factors (Baseline characteristics)
Statistical test will have valid significance levelsStatistical test will have valid significance levels
RR
![Page 53: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/53.jpg)
SAMPLE ALLOCATION(Randomization)
Control Group
Experimental Group
Standard TreatmentPlacebo
InterventionNew Treatment
BLIND
![Page 54: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/54.jpg)
Simple Randomization
Chronologicalpatient No.
112233445566778899101011111212
![Page 55: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/55.jpg)
1048022368241304216737570
7792199562963018957985475
2891863553094291036507119
5108502368010115216207056
0153625595225270624381837
1100856420054636366153342
8823148235526368572971048
5182152404333624636933787
1501146573483609309339975
0690772905919771434236857
6957840961939696112997336
1276521382540925391697628
0201185393972656168016656
4275169994079721028153988
3326703427927378568908178
5125960268949045858609998
9164689198648091637691782
5349831016209221810359533
7993669445334885226713916
1630819885041461451306691
8164730995763950785606121
2775698872188761745353060
7099749626889474823777233
7745289368312732321642698
RANDOM NUMBER
![Page 56: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/56.jpg)
Simple Randomization
Chronologicalpatient No.
Randomnumber
112233445566778899101011111212
112222443377999988882266
![Page 57: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/57.jpg)
Simple RandomizationIf Random number is even assign treatment AIf Random number is odd assign treatment B
Chronologicalpatient No.
Randomnumber Assignment
112233445566778899101011111212
112222443377999988882266
![Page 58: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/58.jpg)
Simple RandomizationIf Random number is even assign treatment AIf Random number is odd assign treatment B
Chronologicalpatient No.
Randomnumber Assignment
112233445566778899101011111212
112222443377999988882266
BBAAAAAABBBBBBBBAAAAAAAAA7A7B5B5?
![Page 59: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/59.jpg)
BLOCK RANDOMIZATIONBLOCK RANDOMIZATION
AVOID AVOID IMBALANCEIMBALANCE IN NO. SUBJECTS ASSIGNED IN NO. SUBJECTS ASSIGNED TO EACH GROUPTO EACH GROUP
NO. SUBJECTSNO. SUBJECTS IN EACH gr. WILL IN EACH gr. WILL BE EQUALBE EQUAL
METHODMETHOD
CHOOSE CHOOSE BLOCK BLOCK OF OF EVEN SIZEEVEN SIZE (e.g.4) (e.g.4)(ENSURE THAT AFTER EVERY 4 R SUBJECT(ENSURE THAT AFTER EVERY 4 R SUBJECTNO. SUBJECTSNO. SUBJECTS IN EACH gr. IS IN EACH gr. IS EQUALEQUAL))
WRITE DOWN ALL WRITE DOWN ALL POSSIBLE WAYSPOSSIBLE WAYS OF OF gr. ASSIGNMENTgr. ASSIGNMENT
R THE R THE ORDER ORDER IN WHICH THESE COMBINATIONA ARE IN WHICH THESE COMBINATIONA ARE SELECTEDSELECTED
![Page 60: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/60.jpg)
All possible ways of ‘Group assignment’All possible ways of ‘Group assignment’
I II III IV V VI
![Page 61: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/61.jpg)
All possible ways of ‘Group assignment’All possible ways of ‘Group assignment’
I II III IV V VIA B A B A BA B B A B AB A A B B AB A B A A B
R the ‘order’ in whichR the ‘order’ in whichthese combinationthese combinationare selectedare selected
BLOCKBLOCKII, VI, IV, III, I, VII, VI, IV, III, I, V
ChronologicalPatient No.
Block Assignment
1234
II BBAA
5678
VI BAAB
9..
IV BA
![Page 62: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/62.jpg)
PROGNOSTIC STRATIFICATIONPROGNOSTIC STRATIFICATION
H.T.H.T.
MildMild
ModerateModerate
SevereSevere
SEVERITYSEVERITY
Prognostic factorPrognostic factor
RR
EE
CC
RR
EE
CC
RR
EE
CC
![Page 63: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/63.jpg)
Prognostic Stratification
SEX
40 - 49
50 - 59
60 - 69
MildModerateSevere
EC
40 - 49
50 - 59
60 - 69
MildModerateSevere
+
AGE SEVERITY
R
EC
R
R
R
R
R
![Page 64: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/64.jpg)
INTERVENTION (MANOEUVRE)
PRECISIONPRECISION POTENCYPOTENCY COMPARISONCOMPARISON MULTIPLICITYMULTIPLICITY CONCURRENCYCONCURRENCYSENSIBILITYSENSIBILITYAVAILABILITYAVAILABILITYACCEPTABILITYACCEPTABILITYAVOID BIASESAVOID BIASES CONTAMINATIONCONTAMINATION COINTERVENTIONCOINTERVENTION COMPLIANCECOMPLIANCE
![Page 65: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/65.jpg)
HISTORICAL CONTROL TRIAL
333328285513139944INH + PASINH + PAS2020191911INH + RFINH + RF
NONOYESYESDEATHDEATH
5.05.0%%30.8%30.8%
4141303011111919141455INH + PASINH + PAS2222161666INH + RFINH + RF
NONOYESYESDEATHDEATH
27.3%27.3%26.3%26.3%
![Page 66: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/66.jpg)
CONTAMINATION
SAMPLE R
CONTROLGROUP
INTERVENTION
EXPERIMENTALGROUP
INTERVENTION 10
SECONDARY
1.1.2.2.3.3.
F.U.
F.U.
OUTCOMEMEASUREMENT
![Page 67: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/67.jpg)
SAMPLE R
CONTROLGROUP
STANDARD RxPLACBBO
EXPERIMENTALGROUP
INTERVENTION 10
SECONDARY
1.2.3.
F.U.F.U.
F.U.F.U.
OUTCOMEMEASUREMENT
CO-INTERVENTION
![Page 68: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/68.jpg)
THE USEFULNESS OFTHE USEFULNESS OF
BLINDNESSBLINDNESS
Avoid CO-INTERVENTIONAvoid CO-INTERVENTION
Avoid Biased of OUTCOME MEASUREMENTAvoid Biased of OUTCOME MEASUREMENT
![Page 69: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/69.jpg)
FIVE YEAR MORTALITY IN THE CORONARY DRUG PROJECTFIVE YEAR MORTALITY IN THE CORONARY DRUG PROJECT
POORPOORCOMPLIANCECOMPLIANCE
<80%<80%
GOODGOODCOMPLIANCECOMPLIANCE
>>80%80%
# ofPts.
357
882
%mortality
24.6
28.2
# ofPts.
708
1813
%mortality
15.0
15.1
Clofibrate
Placebo
![Page 70: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/70.jpg)
COMPINANCE IMPROVING STRATEGIES(SHORT-TERM Rx)
1.1. Clear verbal and written instructionClear verbal and written instruction2.2. Patient CounsellingPatient Counselling3.3. Intramuscular injectionIntramuscular injection4.4. Pill calendarsPill calendars5.5. Unit dose packagesUnit dose packages6.6. Signal-alarm pill containersSignal-alarm pill containers
![Page 71: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/71.jpg)
COMPINANCE IMPROVING STRATEGIES(LONG-TERM Rx)
1.1. Increased supervision Increased supervision (especially by paraprofessionals)(especially by paraprofessionals)2.2. Rewards and positive reinforcement for complyingRewards and positive reinforcement for complying3.3. Cueing (tailoring of the regimen to the patient’s Cueing (tailoring of the regimen to the patient’s
habits)habits)4.4. Self-monitoringSelf-monitoring5.5. Contingency contractingContingency contracting6.6. Counselling, instruction, and group discussionsCounselling, instruction, and group discussions7.7. Parenteral treatment under supervisionParenteral treatment under supervision8.8. Increased convenience of care-regimenIncreased convenience of care-regimen
![Page 72: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/72.jpg)
- Follow up - Self report
Pill count Home Surprise Visit
Laboratory Test
Compliance MonitoringRx
![Page 73: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/73.jpg)
OUTCOME
HARDOBJECTIVE
SOFTSUBJECTIVE
V.S.V.S.INDICATOR CRITERIA
P.E.P.E.LAB.LAB.
PAINPAINANXIETYANXIETYNAUSIANAUSIA
![Page 74: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/74.jpg)
RELEVANT TO THE STUDY QUESTIONRELEVANT TO THE STUDY QUESTION
CAPABLE OF OPERATIONAL DEFINTIONCAPABLE OF OPERATIONAL DEFINTION
CREDIBLECREDIBLE
COMPREHENSIBILITYCOMPREHENSIBILITY
ACCEPTANCEACCEPTANCE
ACCURACYACCURACY
RELIABILITYRELIABILITY
RESPONSIVENESS TO CHANGERESPONSIVENESS TO CHANGE
AVAILABILITY & COSTAVAILABILITY & COST
CRITERIA FOR SELECTING HEALTH MEASURES
![Page 75: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/75.jpg)
Consequence ofConsequence of‘‘Cholesterol - lowering drug therapy’Cholesterol - lowering drug therapy’
TCTC
LDL - CLDL - C
HDL - CHDL - C Mortality
CHDOther Causes
Prevent‘atherosclerosis’
CHD
QOL
![Page 76: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/76.jpg)
OutOutputput Outcome Impact Outcome Impact
LEVEL OF OUTCOME MEASUREMENT
Intermediatelevel
Tertiarylevel
Secondarylevel
HEALTHCARE
PROGRAM
![Page 77: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/77.jpg)
เท่ียง ตรง(RELIABILITY) (VALIDITY)
CONTENTCONTENT
FACEFACE
CRITERIONCRITERION
DISCRIMINANTDISCRIMINANT
CONSTRUCTCONSTRUCT
VARIATIONVARIATION
Observer Instrument Subject
Intra-Observer
Inter-ObserverQuestionnaire
Record Form
Enumeration/Measurement
![Page 78: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/78.jpg)
SOURCES OFOBSERVERS VARIATIONS
MULTIPLE OBSERVERS
DIFFERENT INSTITUTIONS
DIFFERENT TECHNICAL CONSTRAINS
DIFFERENT Dx. PRACTICES
DIFFERENT IN COMPLETENESS OF
MEDICAL RECORDS
![Page 79: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/79.jpg)
APPROACH TO VARIATIONS
COMMON PROTOCOL
STANDARDIZATION OF METHODS
TRAINING OF PERSONNELS
![Page 80: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/80.jpg)
OUTCOMEOUTCOMEMEASUREMEASURECRITERIA FOR SELETING OUTCOME MEASURECRITERIA FOR SELETING OUTCOME MEASURE
RELEVANCEOPERATIONALDEFINITIONCREDIBLEACCURACYAVAILABLE
Low Cost?
![Page 81: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/81.jpg)
OUTCOMEMEASURE
DataSourc
e
HOWto
Measure ?
WHOwill
measure ?
REMARKS(U of Analysis)
WHENwill
measure ?OBJECTIVES
1………………….
2………………….
3………………...
1.1)….....……1.2)…………..1.3)…………..
2.1)…………..2.2)…………..
3.1)………….
……………..……………..……………..
……………..……………..
……………..
……………………….……………………….……………………….
……………………….……………………….
……………………….
……………………….……………………….……………………….
……………………….……………………….
……………………….
……………………….……………………….……………………….
……………………….……………………….
……………………….
………………………………………………………………
…………………………………………
……………………
![Page 82: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/82.jpg)
APPROACH TO VARIATIONS
COMMON PROTOCOL
STANDARDIZATION OF METHODS
TRAINING OF PERSONNELS
![Page 83: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/83.jpg)
OUTCOMEOUTCOMEMEASUREMEASURECRITERIA FOR SELETING OUTCOME MEASURECRITERIA FOR SELETING OUTCOME MEASURE
RELEVANCEOPERATIONALDEFINITIONCREDIBLEACCURACYAVAILABLE
Low Cost?
![Page 84: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/84.jpg)
OUTCOMEMEASURE
DataSourc
e
HOWto
Measure ?
WHOwill
measure ?
REMARKS(U of Analysis)
WHENwill
measure ?OBJECTIVES
1………………….
2………………….
3………………...
1.1)….....……1.2)…………..1.3)…………..
2.1)…………..2.2)…………..
3.1)………….
……………..……………..……………..
……………..……………..
……………..
……………………….……………………….……………………….
……………………….……………………….
……………………….
……………………….……………………….……………………….
……………………….……………………….
……………………….
……………………….……………………….……………………….
……………………….……………………….
……………………….
………………………………………………………………
…………………………………………
……………………
![Page 85: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/85.jpg)
Long Term Clinical TrialsLong Term Clinical TrialsFor Possible Early TerminationFor Possible Early Termination
Unexpected HarmUnexpected HarmClear Therapeutic BenefitClear Therapeutic Benefit
would we want to stop ?would we want to stop ?
Optimal care of study patientsOptimal care of study patientsOptimal care of nonstudy &Optimal care of nonstudy &future patients through quickerfuture patients through quickerpublication of the resultspublication of the resultsEfficient use of time & resourcesEfficient use of time & resources(invertigators)(invertigators)
would we want to stop ?would we want to stop ?
MONITORINGMONITORING
WHENWHEN
WHYWHY
![Page 86: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/86.jpg)
QUALITY OF RESEARCH WORK
DESIGN METHODOLOGY
STATISTICS
Adm.KNOWLEDGEOF
THE SUBJECT
STATE-OF-THE-ART
![Page 87: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/87.jpg)
TEAM WORKrust (เชื่อใจซึง่กันและกัน)
nthusiasm (กระตือรอืรน้)greement (ประคับประคอง)
utual Benefit (ผลประโยชน์รว่มกัน)illingness (ต้ังใจ & เต็มใจ)pportunity (ให้โอกาสฯ)
ecognition (ยอมรบันับถือ)nowledge Transfer (แลกเปลี่ยนความรู)้
TEAMWORK
![Page 88: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/88.jpg)
ETHICS : NORMETHICS : NORM
Scientifit DesignScientifit DesignCompetent InvestigatorCompetent InvestigatorRisk / Benefit BalanceRisk / Benefit BalanceInform ConsentInform ConsentConfidentialityConfidentialitySelection of SubjectsSelection of SubjectsCompensation of InjuryCompensation of Injury
![Page 89: Introductory course on Field Epidemiology Prof.Dr.Pirom Kamol - Ratanakul June 27, 2006 09.00 - 12.00 a.m. EXPERIMENTALSTUDY.](https://reader035.fdocument.pub/reader035/viewer/2022062523/5a4d1ae87f8b9ab059979e1c/html5/thumbnails/89.jpg)
THANKTHANK