Study Designs and related

Community DentistryUpdated 5 min read
On this page 14 sections

💡General

  1. Age groups for study = 5, 12, 15, 35-44, 65-74
  2. Emporiatrics = Health of travellers
  3. Definition of epidimiology = MacMohan
  4. Socratic method of communication = Two way communication
  5. Tableau = skit / roleplay
  • Rate: Measures the occurrence of an event per unit size of population over a specified period.
  • Ratio: Compares two independent quantities (x:y) where the numerator is not part of the denominator.
  • Proportion: A specific ratio where the numerator is included in the denominator, usually expressed as a percentage (x/(x+y)×100).
  • Index case: The first case/patient that comes to the attention of the investigator or health authorities.
  • Primary case: The individual who introduces the disease/infection into a susceptible population or group (the actual patient zero who may or may not be identified first).
  • Secondary case: A person who contracts the disease from exposure to a primary case.

💡Designs

StudyStarts withDirectionMain measure/use
Cross-sectionalPopulationSnapshotPrevalence
Case-controlDiseaseBackward → exposureOR
CohortExposureForward → diseaseRR, incidence
RCTIntervention assignedForwardRisk, RR, treatment effect
EcologicalPopulation/groupUsually observationalPopulation-level association
Case reportOne caseDescriptionRare/unusual disease
Case seriesSeveral casesDescriptionRare/unusual disease

💡Levels of Prevention

Traditionally there are 3 levels:

  1. Primary prevention → prevent disease from occurring
  2. Secondary prevention → detect disease early + treat it
  3. Tertiary prevention → reduce disability/restore function

There is also primordial prevention, which comes before primary prevention. Prevent the development of risks themselves.

💡Phases of Drug/Clinical Development

StageMain purposeSubjectsKey FCPS clue
Preclinical ⭐Safety, toxicity, pharmacology before human testingLaboratory + animalsBefore humans
Phase 0Very early exploratory pharmacokinetic/pharmacodynamic studiesVery small number of humansMicrodose / exploratory
Phase I ⭐Safety, tolerability, dose rangeSmall number of humans, often healthy volunteersIs it safe?
Phase II ⭐Efficacy + dose findingPatients with the diseaseDoes it work?
Phase III ⭐Confirm efficacy & safety; compare with standard treatment/placeboLarge number of patientsConfirm/compare
Phase IV ⭐Post-marketing surveillanceGeneral populationAfter approval

💡Epidemiological Measures

MeasureFormulaMainly used inWhat it tells you
Relative Risk (RR) ⭐⭐⭐Risk in exposed / Risk in unexposedCohortHow many times greater/lower is the risk?
Odds Ratio (OR) ⭐⭐⭐ad / bcCase-controlRatio of odds of exposure/disease
Attributable Risk (AR) ⭐⭐⭐Riskₑ − RiskᵤCohortExcess risk due to exposure

💡ACCURACY, PRECISION, VALIDITY AND RELIABILITY

TermDefinitionDental ExampleKey Point
AccuracyCloseness of a measurement to the true valueA scale reads 70.1 kg when the true weight is 70.0 kgSystematic error affects accuracy
PrecisionCloseness of repeated measurements to one anotherRepeated readings are 70.1, 70.1 and 70.2 kgMainly reflects random variation
ValidityExtent to which an instrument measures what it is intended to measureA questionnaire genuinely measures oral-health knowledgeA reliable test may still be invalid
ReliabilityConsistency or reproducibility of measurementsTwo examiners record similar DMFT scores for the same patientReliable results are reproducible
RobustnessAbility to maintain performance under reasonable variations in testing conditionsAn instrument remains dependable under routine operating conditionsNot identical to reliability

💡Types of reliability

TypeDefinitionExample
Test–retest reliabilitySame instrument gives similar results on separate occasions when the measured characteristic has not changedA patient repeats the same knowledge questionnaire
Intra-rater reliabilitySame examiner produces consistent ratingsOne dentist records similar periodontal scores on repeat assessment
Inter-rater reliabilityDifferent examiners produce consistent ratingsTwo dentists independently assess the same radiographs
Internal consistencyItems intended to measure the same construct show consistencyQuestions in an oral-health knowledge scale assess a coherent construct

💡DIAGNOSTIC TESTS

💡SENSITIVITY, SPECIFICITY, PPV AND NPV

These are important concepts in screening and diagnostic testing.

The 2 × 2 table

Disease PresentDisease AbsentTotal
Test PositiveTrue Positive (TP)False Positive (FP)TP + FP
Test NegativeFalse Negative (FN)True Negative (TN)FN + TN
TotalTP + FNFP + TNTotal tested

Definitions:

  • True positive (TP): Disease is present and the test is positive.
  • False positive (FP): Disease is absent but the test is positive.
  • False negative (FN): Disease is present but the test is negative.
  • True negative (TN): Disease is absent and the test is negative.

💡Formulas and definitions

MeasureFormulaMeaning
SensitivityTP / (TP + FN) × 100Among people with disease, how many test positive?
SpecificityTN / (TN + FP) × 100Among people without disease, how many test negative?
Positive predictive value (PPV)TP / (TP + FP) × 100Given a positive test, what is the probability the person has disease?
Negative predictive value (NPV)TN / (TN + FN) × 100Given a negative test, what is the probability the person does not have disease?
Overall accuracy(TP + TN) / Total tested × 100Proportion of all tested people correctly classified

Worked example

A dental screening test is performed on 200 people.

  • 40 have disease and test positive (TP).
  • 10 have disease but test negative (FN).
  • 30 do not have disease but test positive (FP).
  • 120 do not have disease and test negative (TN).
MeasureCalculationResult
Sensitivity40 / (40 + 10) × 10080%
Specificity120 / (120 + 30) × 10080%
PPV40 / (40 + 30) × 10057.1%
NPV120 / (120 + 10) × 10092.3%
Overall accuracy(40 + 120) / 200 × 10080%

A negative result is reassuring in this example, but a positive result does not mean that disease is certain.

Effect of prevalence on predictive values

When Disease Prevalence IncreasesUsual Effect
PPVIncreases
NPVDecreases
SensitivityDoes not mathematically depend on prevalence
SpecificityDoes not mathematically depend on prevalence

Sensitivity and specificity may nevertheless vary across populations because of differences in disease severity, patient selection and testing conditions.

Likelihood ratios

MeasureFormulaInterpretation
Positive likelihood ratio (LR+)Sensitivity / (1 − Specificity)How much more likely a positive result is in someone with disease than without disease
Negative likelihood ratio (LR−)(1 − Sensitivity) / SpecificityHow much a negative result changes the odds of disease

A high LR+ helps rule disease in, while a low LR− helps rule disease out. Predictive values still depend on the patient's pre-test probability.