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Medical Statistics –Medical Statistics –
The BasicsThe Basics
Dr Vivek Baliga BDr Vivek Baliga B
Consultant Internal Medicine,Consultant Internal Medicine,
Baliga Diagnostics Pvt. LtdBaliga Diagnostics Pvt. Ltd
What is Statistics?
• Science of collecting, organising and
interpreting numerical facts
• Science of learning from data :
– Design the data collection
– Prepare the data for analysis
– Analyse the data
– Communicate the results of the data
Topics to cover
• Types of data
• Types of studies
• Displaying data
Types of data
• Quantitative
(How much?)
– Measured : BP,
Height
– Counted : Attacks
of asthma a week
• Categorical
(What type?)
– Nominal : Sex
(m/f), hair colour
– Ordinal : Grade of
breast Ca
– Binary :
Male/Female,
Dead/alive
Measures of Effect
• Describe the measure that is used to
compare treatment effects in 2 or
more comparison groups
Measure of Effect
• Quantitative Variables
– Mean
– Median
• Categorical Variables
– Risks
– Odds Ratio
• Mean
1+2+3+6+7+12+18 = 49
Mean = 49/7 =7
• Median (Odd number N)
1+2+3+6+7+12+18
Median =6
• Median (Even number N)
2+3+6+7+12+18
Median = 6+7/2 = 6.5
Normal Distribution Curve
Standard Deviation
2+8+10+13+22 = 55
Mean = 55/5 =11
Variance = (2-11)2
+(8-11)2
+(10-11)2
+(13-11)2
+(22-11)2
N-1
= 216/4 = 54
Standard Deviation = √54 = 7.2
Standard deviation
• Estimate of variability of
observations
• Larger sample provides a better and
more precise estimate of the
standard deviation.
Measures of Effect
• Absolute risk : A/A+C
• Relative Risk :
A/A+C÷B/B+D
• Absolute risk
reduction : A/A+C-
B/B+D
• Number needed to
treat : 1/ARR
D+ D-
Ex+ A B
Ex- C D
A+C B+D
Types of studies
• Randomised control trials
• Cohort studies
• Case control studies
• Cross sectional studies
• Case reports
Randomised Control
Trials
• Gold standard in medical research
• Best to study cause vs effect
• Various components
– Randomisation
– Blinding
– Controlled
Randomised Control
Trials
Select a population
Select a Sample
Make necessary exclusions
Randomise
Experimental group Control group
Randomised Control
Trials
• Randomisation
– Each patient has an equal chance of each
treatment option
– Fair unbiased comparison of treatment
Randomised Control
Trials
• Blinding
– Single blind : patient cannot predict
which treatment they get
– Double blind : neither patient nor
investigator knows
– Triple blind : Neither pt, investigator or
person administering treatment (eg
pharmacist) knows
Randomised Control
Trials
• Controlled trial
– Placebo controlled : Simvastatin vs
placebo
– Active control : Simvastatin vs
Pravastatin
– Active – placebo –control : Simvastatin
vs pravastatin vs placebo
Randomised Control
Trials
• Advantages
– Prospective design
– Rigorous evaluation
of a single variable
– Eradicates bias
– Uses null
hypothesis
• Disadvantages
– Expensive
– Time consuming
Cohort studies
• Cohort is a group of people who share a
common characteristic or experience
within a defined time period
• Eg : People born in 1980= birth cohort
• Cohort studies are done to obtain
additional evidence that there is an
association between a suspected cause
and disease.
Cohort studies
• Prospective
– Follow up in years
– Can collect confounding factors
– Expensive, time consuming
– E.g.: Framingham heart study
• Retrospective
– Incomplete information
– Confounding factors may not be collected
– Quick, cheap
– E.g.: angiosarcoma in relation to poly-vinyl chloride
Cohort studies- Elements
• Selection of subjects
– General population
– Special groups eg: Dolls study of
smoking and lung cancer in British
doctors in 1951
– Exposure groups : eg radiologists and X-
rays
Cohort studies- Elements
• Obtaining data
– Interviews/questionnaires – dolls study
– Review of records
– Medical examination and special tests
– Environmental surveys – exposure etc
Cohort studies- Elements
• Selection of comparison groups
– Internal – within the cohort
– External – eg radiologists vs
ophthalmologists
– General population
Cohort studies- Elements
• Follow up
– Periodic examination - best method
– Questionnaires
– Review of records periodically
Cohort studies- Elements
• Analysis
– Incidence rates
– Estimation of risk
• Relative risk
• Attributable risk
Cohort studies- Elements
• Incidence rates
– Exposed 70/7000 = 10
per 1000
– Non Exposed 3/3000 =
1 per 1000
• Relative risk =10/1 = 10
• Attributable risk =
[(10-1)/10]x100 = 90%
Cigarette
smoking
Ca + Ca - Total
Yes 70 (a) 6930
(b)
7000
(a+b)
No 3(c) 2997
(d)
3000
(c+d)
Cohort studies- Risks
• Relative risk
– Incidence among exposed
Incidence among non exposed
– RR = 1 means no association
– RR > 1 implies ‘positive’ association
– Smokers are 10 times at risk of lung Ca that
non smokers.
Cohort studies- Risks
• Attributable risks
– Incidence among exposed-non exposed x100
Incidence among exposed
– Tells us to what extent the disease under study can be
attributed to the exposure.
Cohort studies
• Strengths
– Valuable if
exposure is rare
– Examine multiple
effects of an
exposure
– Can measure
incidence of a
disease
• Limitations
– Cannot evaluate
rare diseases
– Expensive and
time consuming if
prospective
– Several losses to
follow up can
effect validity
Case Control Study
• Retrospective study
• Both exposure and outcome have
occurred before the start of the
study
• Uses a ‘control’ or comparison group
Case Control Study
• Selection of cases and controls
• Matching
• Measurement of exposure
• Analysis and interpretation
Case Control Study-
Analysis
• Exposure rates
• Relative risk
• Odds ratio
Case Control Study
• Exposure rates
– Cases a/(a+c) =94.2%
– Controls b/(b+d) = 67%
• Relative risk = a/a+c ÷b/b+d
• Odds ratio = ad/bc = 8.1
– Smokers of < 5/day have a
risk of developing lung cancer
8.1 times that of non-
smokers.
Cases
(with
lung Ca)
Controls
(without
Lung Ca)
Smokers
(<5/day)
33 (a) 55 (b)
Non
Smokers
2(c) 27(d)
Total 35 (a+c) 82 (b+d)
Bias in Case Control
Study
• Confounding factors – alcoholism and
oesophageal cancer; smoking is a
confounding factor.
• Recall bias
• Selection bias
• Interviewers bias
Cross sectional studies
• ‘Prevalence study’
• Based on a single examination of a
cross section of population at one
point in time.
Meta-analysis
• Statistical analysis of the results
from independent studies, which
generally aims to produce a single
estimate of treatment effect.
Displaying Data
• Bar Charts
• Histogram
• Line diagrams
• Pie charts
• Scatter plots
• Forest plots
THANK YOU!

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Dr Vivek Baliga - The Basics Of Medical Statistics

  • 1. Medical Statistics –Medical Statistics – The BasicsThe Basics Dr Vivek Baliga BDr Vivek Baliga B Consultant Internal Medicine,Consultant Internal Medicine, Baliga Diagnostics Pvt. LtdBaliga Diagnostics Pvt. Ltd
  • 2. What is Statistics? • Science of collecting, organising and interpreting numerical facts • Science of learning from data : – Design the data collection – Prepare the data for analysis – Analyse the data – Communicate the results of the data
  • 3. Topics to cover • Types of data • Types of studies • Displaying data
  • 4. Types of data • Quantitative (How much?) – Measured : BP, Height – Counted : Attacks of asthma a week • Categorical (What type?) – Nominal : Sex (m/f), hair colour – Ordinal : Grade of breast Ca – Binary : Male/Female, Dead/alive
  • 5. Measures of Effect • Describe the measure that is used to compare treatment effects in 2 or more comparison groups
  • 6. Measure of Effect • Quantitative Variables – Mean – Median • Categorical Variables – Risks – Odds Ratio
  • 7. • Mean 1+2+3+6+7+12+18 = 49 Mean = 49/7 =7 • Median (Odd number N) 1+2+3+6+7+12+18 Median =6 • Median (Even number N) 2+3+6+7+12+18 Median = 6+7/2 = 6.5
  • 9. Standard Deviation 2+8+10+13+22 = 55 Mean = 55/5 =11 Variance = (2-11)2 +(8-11)2 +(10-11)2 +(13-11)2 +(22-11)2 N-1 = 216/4 = 54 Standard Deviation = √54 = 7.2
  • 10. Standard deviation • Estimate of variability of observations • Larger sample provides a better and more precise estimate of the standard deviation.
  • 11. Measures of Effect • Absolute risk : A/A+C • Relative Risk : A/A+C÷B/B+D • Absolute risk reduction : A/A+C- B/B+D • Number needed to treat : 1/ARR D+ D- Ex+ A B Ex- C D A+C B+D
  • 12. Types of studies • Randomised control trials • Cohort studies • Case control studies • Cross sectional studies • Case reports
  • 13. Randomised Control Trials • Gold standard in medical research • Best to study cause vs effect • Various components – Randomisation – Blinding – Controlled
  • 14. Randomised Control Trials Select a population Select a Sample Make necessary exclusions Randomise Experimental group Control group
  • 15. Randomised Control Trials • Randomisation – Each patient has an equal chance of each treatment option – Fair unbiased comparison of treatment
  • 16. Randomised Control Trials • Blinding – Single blind : patient cannot predict which treatment they get – Double blind : neither patient nor investigator knows – Triple blind : Neither pt, investigator or person administering treatment (eg pharmacist) knows
  • 17. Randomised Control Trials • Controlled trial – Placebo controlled : Simvastatin vs placebo – Active control : Simvastatin vs Pravastatin – Active – placebo –control : Simvastatin vs pravastatin vs placebo
  • 18. Randomised Control Trials • Advantages – Prospective design – Rigorous evaluation of a single variable – Eradicates bias – Uses null hypothesis • Disadvantages – Expensive – Time consuming
  • 19. Cohort studies • Cohort is a group of people who share a common characteristic or experience within a defined time period • Eg : People born in 1980= birth cohort • Cohort studies are done to obtain additional evidence that there is an association between a suspected cause and disease.
  • 20. Cohort studies • Prospective – Follow up in years – Can collect confounding factors – Expensive, time consuming – E.g.: Framingham heart study • Retrospective – Incomplete information – Confounding factors may not be collected – Quick, cheap – E.g.: angiosarcoma in relation to poly-vinyl chloride
  • 21. Cohort studies- Elements • Selection of subjects – General population – Special groups eg: Dolls study of smoking and lung cancer in British doctors in 1951 – Exposure groups : eg radiologists and X- rays
  • 22. Cohort studies- Elements • Obtaining data – Interviews/questionnaires – dolls study – Review of records – Medical examination and special tests – Environmental surveys – exposure etc
  • 23. Cohort studies- Elements • Selection of comparison groups – Internal – within the cohort – External – eg radiologists vs ophthalmologists – General population
  • 24. Cohort studies- Elements • Follow up – Periodic examination - best method – Questionnaires – Review of records periodically
  • 25. Cohort studies- Elements • Analysis – Incidence rates – Estimation of risk • Relative risk • Attributable risk
  • 26. Cohort studies- Elements • Incidence rates – Exposed 70/7000 = 10 per 1000 – Non Exposed 3/3000 = 1 per 1000 • Relative risk =10/1 = 10 • Attributable risk = [(10-1)/10]x100 = 90% Cigarette smoking Ca + Ca - Total Yes 70 (a) 6930 (b) 7000 (a+b) No 3(c) 2997 (d) 3000 (c+d)
  • 27. Cohort studies- Risks • Relative risk – Incidence among exposed Incidence among non exposed – RR = 1 means no association – RR > 1 implies ‘positive’ association – Smokers are 10 times at risk of lung Ca that non smokers.
  • 28. Cohort studies- Risks • Attributable risks – Incidence among exposed-non exposed x100 Incidence among exposed – Tells us to what extent the disease under study can be attributed to the exposure.
  • 29. Cohort studies • Strengths – Valuable if exposure is rare – Examine multiple effects of an exposure – Can measure incidence of a disease • Limitations – Cannot evaluate rare diseases – Expensive and time consuming if prospective – Several losses to follow up can effect validity
  • 30. Case Control Study • Retrospective study • Both exposure and outcome have occurred before the start of the study • Uses a ‘control’ or comparison group
  • 31. Case Control Study • Selection of cases and controls • Matching • Measurement of exposure • Analysis and interpretation
  • 32. Case Control Study- Analysis • Exposure rates • Relative risk • Odds ratio
  • 33. Case Control Study • Exposure rates – Cases a/(a+c) =94.2% – Controls b/(b+d) = 67% • Relative risk = a/a+c ÷b/b+d • Odds ratio = ad/bc = 8.1 – Smokers of < 5/day have a risk of developing lung cancer 8.1 times that of non- smokers. Cases (with lung Ca) Controls (without Lung Ca) Smokers (<5/day) 33 (a) 55 (b) Non Smokers 2(c) 27(d) Total 35 (a+c) 82 (b+d)
  • 34. Bias in Case Control Study • Confounding factors – alcoholism and oesophageal cancer; smoking is a confounding factor. • Recall bias • Selection bias • Interviewers bias
  • 35. Cross sectional studies • ‘Prevalence study’ • Based on a single examination of a cross section of population at one point in time.
  • 36. Meta-analysis • Statistical analysis of the results from independent studies, which generally aims to produce a single estimate of treatment effect.
  • 37. Displaying Data • Bar Charts • Histogram • Line diagrams • Pie charts • Scatter plots • Forest plots