FCPS Part 1 Biostatistics and epidemiology

Validity and reliability

Validity and Reliability of Measurements: Accuracy, Precision and Kappa

Validity versus reliability, accuracy versus precision, types of validity, test-retest and inter-observer reliability, and kappa with a worked example. Also covers Bland-Altman analysis, sources of measurement error and lab quality control for FCPS Part 1.

Two separate questions about any measurement

  • Validity (accuracy): does the tool measure what it claims to measure, giving the true value? It is damaged by systematic error (bias).
  • Reliability (precision, reproducibility, repeatability): does it give the same result when the measurement is repeated under the same conditions? It is damaged by random error.
  • A measurement can be reliable but not valid: a scale that always reads 2 kg too heavy gives consistent but wrong values. It cannot be truly valid without being reliable, because wildly scattered readings cannot reflect the true value consistently.
Error typeAffectsReduced by
Systematic (bias)Validity, accuracyCalibration, better design, blinding
RandomReliability, precisionRepeated measurements, larger samples, standard protocols

Remember Valid means on target; reliable means repeatable.

Exam trap Reliability is the extent to which a procedure gives the same result on repetition; it says nothing about whether the result is correct.

Accuracy and precision: the target picture

Shots on a targetAccuracy (validity)Precision (reliability)
Tightly grouped on the bullseyeHighHigh
Tightly grouped away from the bullseyeLow (biased)High
Scattered evenly around the bullseyeHigh on averageLow
Scattered away from the centreLowLow

Types of validity

TypeQuestion
Face validityOn inspection, does it look as if it measures the concept?
Content validityDoes it cover all relevant aspects (judged by experts)?
Criterion validityDoes it agree with a gold standard? Concurrent (same time) or predictive (forecasts a later outcome)
Construct validityDoes it correlate with related measures (convergent) and not with unrelated ones (discriminant)?
  • For a diagnostic test, criterion validity is expressed as sensitivity and specificity against the gold standard. Specificity is the ability to correctly exclude people who do not have the disease; sensitivity is the ability to correctly identify those who do, so a negative result on a highly sensitive test rules disease out.
  • Accuracy of a test overall = (true positives + true negatives) ÷ all tested: the share of results that are correct, positive and negative.
  • For a study, internal validity means results are true for the participants (no bias or confounding) and external validity means they generalise to others.

Types of reliability

TypeMeaningMeasured by
Test–retest (intra-observer, repeatability)Same observer or instrument gives the same result on repeatICC, kappa
Inter-observer (inter-rater)Different observers agreeKappa (categories), ICC (continuous)
Internal consistencyItems in a questionnaire measure the same constructCronbach's alpha
Parallel formsTwo equivalent versions agreeCorrelation

Measuring agreement: kappa

  • When two observers classify findings into categories (present or absent, normal or abnormal), some agreement happens by chance alone. Cohen's kappa measures agreement beyond chance.
  • κ = (observed agreement − expected agreement) ÷ (1 − expected agreement).
  • Worked example: two radiologists agree on 85% of chest films; chance agreement would be 50%. κ = (0.85 − 0.50) ÷ (1 − 0.50) = 0.70, good agreement.
KappaAgreement
Under 0.20Poor
0.21–0.40Fair
0.41–0.60Moderate
0.61–0.80Good (substantial)
Over 0.80Very good (almost perfect)
  • κ = 1 is perfect agreement; κ = 0 is no better than chance; negative values mean less than chance.
  • Intraclass correlation coefficient (ICC) does the same job for continuous measurements.
  • Bland–Altman plot: the difference between two methods is plotted against their mean, with limits of agreement (mean difference ± 1.96 SD of the differences). It is the right way to compare two measuring methods; a high correlation does not prove agreement, because two methods can rise together while one reads consistently higher.

Exam trap Kappa, not percentage agreement or correlation, measures inter-observer agreement on categorical findings, because it removes agreement expected by chance.

Variability statistics

  • Standard deviation measures variability among individual values around the mean; it does not measure reliability, validity or sample size.
  • Coefficient of variation (SD ÷ mean × 100%) expresses the precision of a laboratory assay: a low CV on repeated runs of one sample means good reproducibility.

Sources of measurement error

  • Observer: differences between and within observers, terminal digit preference (rounding BP to 0 or 5), expectation bias.
  • Instrument: poor calibration; a BP cuff that is too small overestimates BP.
  • Subject: biological variation (diurnal BP, white-coat effect, posture, recent exercise).
  • Reduce error with standardised protocols, training, calibration, repeated measurements, blinding of observers to the patient's group (removes observer bias) and automated devices.

Laboratory quality control

  • Internal quality control: control samples of known value run with each batch and plotted on Levey–Jennings charts; Westgard rules flag random or systematic drift.
  • External quality assessment (proficiency testing): an outside body sends unknown samples and compares laboratories.
  • Pre-analytical errors (wrong tube, haemolysis, delay, mislabelling) are the commonest laboratory errors.

How FCPS asks about this

  • Definition of reliability: the extent to which a procedure gives the same result when repeated (reproducibility).
  • Statistic for agreement between two observers beyond chance on categorical findings: Cohen's kappa.
  • Reliable but not valid example: a miscalibrated scale reading consistently heavy.
  • What standard deviation measures: variability among individual values.
  • Comparing two methods of measuring the same quantity: Bland–Altman limits of agreement, not correlation.
  • Ability of a test to correctly exclude non-diseased people: specificity; sensitivity identifies the diseased.
  • Internal consistency of a questionnaire: Cronbach's alpha.

Test yourself on this topic

5 of the 6 questions in our bank on this topic. Choose an answer to see why every option is right or wrong.

Question 1Medium

A weighing scale in an OPD gives readings within 0.1 kg of each other when a child is weighed three times, but every reading is 1.5 kg above the true weight. How is this scale best described?

Question 2Easy

A 50-g glucose challenge test is evaluated in an antenatal clinic. Of 120 women later confirmed by OGTT to have gestational diabetes, 102 had a positive challenge test. What is the sensitivity of the challenge test?

Question 3Medium

Which statistic measures agreement between two observers beyond chance for categorical findings?

Question 4Medium

A bedside test for preterm prelabour rupture of membranes is evaluated in 500 women. It gives 90 true positives, 10 false negatives, 50 false positives and 350 true negatives. What is the overall accuracy of the test?

Question 5Medium

A new blood pressure device gives readings that agree closely with intra-arterial measurements. Which property is this?

Practise all 6 questions on this topic

Where this sits in the CPSP syllabus

  • Paper 1: Biostatistics, Validity and reliability of measurements

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