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STATISTICAL
FALLACIES AND
ERRORS IN MEDICAL
RESEARCH
A. Indrayan
PhD(OhioState), FAMS, FRSS, FASc
Delhi
CONSIDER
 Almost everybody has more legs
than the world average
 Head in an oven and feet in a freezer,
and the person is comfortable
ON AVERAGE???
 Most people die in bed
—avoid bed to prolong life!!!
ALSO
• Bikini
• Lies
• Curse of Kelvin
• Ghost of Gauss
I. BIASED SAMPLE
• Survivors (lung functions and old age)
• Volunteers (trials)
• Clinic subjects (severe, well-to-do)
• Publication bias (no other source)
II. INADEQUATE SIZE OF SAMPLE
• Freiman et al. studied 71 negative RCTs –
sample size too small to detect 25%
improvement; Dimmick et al. reported
similar findings for surgical trials
• Small sample has high SE (not a problem)
but very likely to be not representative
• More important for rare outcomes,
multivariable situations
• Problems with calculation of sample size
III. INCOMPARABLE GROUPS
• Women on oral contraceptives were
observed for thromboembolism but not
those on mechanical devices
• Difference in composition
• Peptic ulcer in blood groups O, A, B and
AB 45%, 35%, 15% and 5%.
Group Number of Subjects Number Responded Response Rate (%)
I. Treatment group 40 32 80.0
Mild 30 26 86.7
Severe 10 6 60.0
II. Control group 40 25 62.5
Mild 8 7 87.5
Severe 32 18 56.2
IV. MIXING OF GROUPS
BMI
Hb
NOW ADD AN OUTLIER
BMI
Hb
Lower SE class
Upper SE class
SCHOOL-1
SCHOOL-2
100 200 300 400
Serum cholesterol level (mg/dL)
n=500
Normocholestremics
n=100 Hypercholestremics
Composite curve
V. IGNORING REALITY
Looking for linearity
Overlooking assumptions –
uniformity of variance (BP, BMI), n for
logistic
Area under the
concentration curve
Anamolous person-years
VI. CHOICE OF ANALYSIS
• Mean or proportion (Hb)
• Forgetting baseline values - Hb
• Interpretation of relative risk (from 10%
to 50% is five times and from 1% to 5%
is also five times)
VII. MISUSE OF STATISTICAL PACKAGES
• Over-analysis (multiple comparisons on
the same data)
• Data dredging (reanalyze after deleting
inconvenient values)
• Torture the data until they confess
• Quantitative analysis of codes - scores
VIII. ERRORS IN PRESENTATION
Misuse of percentage
 2 out of 5 – 40% and 3 out of 5 – 60%
A gain of 20%!
 If waiting time for a surgery reduced from 6
months to 1 month due to administrative
changes, is the reduction 500%, or 83%?
 If efficacy of a regimen is 80% against 60% of
the existing, is the gain 20% or one-third?
Misuse of means
• Head, oven, freezer… n, SD
• ±SD, ±SE (± is valid at all?)
• How about ±2SD (some use even SE)?
• Outlier values
Unnecessary decimals
• P=0.0000075
• Survival time 3.7534 years
• In regression b=1.07 if birth weight
is in kg same as 0.00107 if it is in g
•Mean, SD, one extra decimal
Misuse of graphs
• n is disregarded (1 out of 2 is 50%
so is 45 out of 90 – both shown
same way)
• SD rarely depicted (±SD or ±2SD)
• Statistical significance not shown
b
0
50
100
150
0 10 20 30 40 50 60 70
Age (years)
Average
systol
ic
BP
(mmH
g)
a
115
120
125
130
135
140
145
0 10 20 30 40 50 60 70
Age (years)
Average
systol
ic
BP
(mmH
g)
b
0
50
100
150
0 10 20 30 40 50 60 70
Age (years)
Average
systol
ic
BP
(mmH
g)
a
115
120
125
130
135
140
145
0 10 20 30 40 50 60 70
Age (years)
Average
systol
ic
BP
(mmH
g)
Fallacies indrayan
IX. MISINTERPRETATION
Misuse of P-values
• “Magic” threshold 0.05 (P more for quasi-
random sample, nonGaussian distn.)
• One-tail or two-tail
• Dramatic P-values (P<0.000,000,000,01)
(many packages stop at 3 decimals)
• P-values for nonrandom samples
• Multiple P-values
• Too much emphasis on P-values - must be
accompanied by biological explanation and
plausibility
Correlation vs. cause-effect
• Positive correlation between visual acuity
and vital capacity in people of age > 50
years
• Negative correlation between birth rate
and CVD mortality in India since 1950
• Correlation between depression and risk
of lung cancer due to smoking (seemingly
nonsense correlation can generate a
useful hypothesis)
Correlation vs. agreement
• One sphygmo gives 4mmHg higher every
time (bubble) than the other.
Agreement is poor but r=1!!!
• Comparison of test values with gold
standard, and comparison of two tests
when both can be in error—efficacy vs.
agreement
Sundry issues
• Medical significance vs.
statistical significance
• Missing out medically important gains—
negative trials
• Interpretation of SE (p)
p = 0.03 and SE(p) = 0.022 vs.
p = 0.40 and SE (p) = 0.044
Univariate vs. multivariate
• Effect of maternal smoking on “growth”.
Growth is multivariate (weight, length
and head circumference). Individual
variables can be significant but not when
considered together.
• If each healthy measurement has chance
0.05 being declared abnormal, what is the
chance of doing so by 5 measurements
together?
X. FINAL COMMENT
• If a child cuts the finger, blame the knife?
• Unintentional – misuse; Intentional –
abuse
• Dangerous tools in the hands of an
inexpert
• Correct statistics tell the truth, the whole
truth, and nothing but the truth
• Perceive Biostatistics as the science of
managing medical uncertainties
There is no substitute for
common sense—do not
replace it with
“evidence”—empiricism
vs. rationalism

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Fallacies indrayan

  • 1. STATISTICAL FALLACIES AND ERRORS IN MEDICAL RESEARCH A. Indrayan PhD(OhioState), FAMS, FRSS, FASc Delhi
  • 2. CONSIDER  Almost everybody has more legs than the world average
  • 3.  Head in an oven and feet in a freezer, and the person is comfortable ON AVERAGE???
  • 4.  Most people die in bed —avoid bed to prolong life!!!
  • 5. ALSO • Bikini • Lies • Curse of Kelvin • Ghost of Gauss
  • 6. I. BIASED SAMPLE • Survivors (lung functions and old age) • Volunteers (trials) • Clinic subjects (severe, well-to-do) • Publication bias (no other source)
  • 7. II. INADEQUATE SIZE OF SAMPLE • Freiman et al. studied 71 negative RCTs – sample size too small to detect 25% improvement; Dimmick et al. reported similar findings for surgical trials • Small sample has high SE (not a problem) but very likely to be not representative • More important for rare outcomes, multivariable situations • Problems with calculation of sample size
  • 8. III. INCOMPARABLE GROUPS • Women on oral contraceptives were observed for thromboembolism but not those on mechanical devices • Difference in composition • Peptic ulcer in blood groups O, A, B and AB 45%, 35%, 15% and 5%. Group Number of Subjects Number Responded Response Rate (%) I. Treatment group 40 32 80.0 Mild 30 26 86.7 Severe 10 6 60.0 II. Control group 40 25 62.5 Mild 8 7 87.5 Severe 32 18 56.2
  • 9. IV. MIXING OF GROUPS
  • 10. BMI Hb NOW ADD AN OUTLIER
  • 11. BMI Hb Lower SE class Upper SE class SCHOOL-1 SCHOOL-2
  • 12. 100 200 300 400 Serum cholesterol level (mg/dL) n=500 Normocholestremics n=100 Hypercholestremics Composite curve
  • 13. V. IGNORING REALITY Looking for linearity Overlooking assumptions – uniformity of variance (BP, BMI), n for logistic Area under the concentration curve Anamolous person-years
  • 14. VI. CHOICE OF ANALYSIS • Mean or proportion (Hb) • Forgetting baseline values - Hb • Interpretation of relative risk (from 10% to 50% is five times and from 1% to 5% is also five times)
  • 15. VII. MISUSE OF STATISTICAL PACKAGES • Over-analysis (multiple comparisons on the same data) • Data dredging (reanalyze after deleting inconvenient values) • Torture the data until they confess • Quantitative analysis of codes - scores
  • 16. VIII. ERRORS IN PRESENTATION Misuse of percentage  2 out of 5 – 40% and 3 out of 5 – 60% A gain of 20%!  If waiting time for a surgery reduced from 6 months to 1 month due to administrative changes, is the reduction 500%, or 83%?  If efficacy of a regimen is 80% against 60% of the existing, is the gain 20% or one-third?
  • 17. Misuse of means • Head, oven, freezer… n, SD • ±SD, ±SE (± is valid at all?) • How about ±2SD (some use even SE)? • Outlier values
  • 18. Unnecessary decimals • P=0.0000075 • Survival time 3.7534 years • In regression b=1.07 if birth weight is in kg same as 0.00107 if it is in g •Mean, SD, one extra decimal
  • 19. Misuse of graphs • n is disregarded (1 out of 2 is 50% so is 45 out of 90 – both shown same way) • SD rarely depicted (±SD or ±2SD) • Statistical significance not shown
  • 20. b 0 50 100 150 0 10 20 30 40 50 60 70 Age (years) Average systol ic BP (mmH g) a 115 120 125 130 135 140 145 0 10 20 30 40 50 60 70 Age (years) Average systol ic BP (mmH g)
  • 21. b 0 50 100 150 0 10 20 30 40 50 60 70 Age (years) Average systol ic BP (mmH g) a 115 120 125 130 135 140 145 0 10 20 30 40 50 60 70 Age (years) Average systol ic BP (mmH g)
  • 23. IX. MISINTERPRETATION Misuse of P-values • “Magic” threshold 0.05 (P more for quasi- random sample, nonGaussian distn.) • One-tail or two-tail • Dramatic P-values (P<0.000,000,000,01) (many packages stop at 3 decimals) • P-values for nonrandom samples • Multiple P-values • Too much emphasis on P-values - must be accompanied by biological explanation and plausibility
  • 24. Correlation vs. cause-effect • Positive correlation between visual acuity and vital capacity in people of age > 50 years • Negative correlation between birth rate and CVD mortality in India since 1950 • Correlation between depression and risk of lung cancer due to smoking (seemingly nonsense correlation can generate a useful hypothesis)
  • 25. Correlation vs. agreement • One sphygmo gives 4mmHg higher every time (bubble) than the other. Agreement is poor but r=1!!! • Comparison of test values with gold standard, and comparison of two tests when both can be in error—efficacy vs. agreement
  • 26. Sundry issues • Medical significance vs. statistical significance • Missing out medically important gains— negative trials • Interpretation of SE (p) p = 0.03 and SE(p) = 0.022 vs. p = 0.40 and SE (p) = 0.044
  • 27. Univariate vs. multivariate • Effect of maternal smoking on “growth”. Growth is multivariate (weight, length and head circumference). Individual variables can be significant but not when considered together. • If each healthy measurement has chance 0.05 being declared abnormal, what is the chance of doing so by 5 measurements together?
  • 28. X. FINAL COMMENT • If a child cuts the finger, blame the knife? • Unintentional – misuse; Intentional – abuse • Dangerous tools in the hands of an inexpert • Correct statistics tell the truth, the whole truth, and nothing but the truth • Perceive Biostatistics as the science of managing medical uncertainties
  • 29. There is no substitute for common sense—do not replace it with “evidence”—empiricism vs. rationalism