Concept Architecture
Intraclass Correlation in Reliability Studies and Clustered Health Data
The intraclass correlation compares how far measurements differ between the units of interest, such as patients or general practices, with how far they differ within those units. In health economics it answers two practical questions, whether a utility instrument or clinical rating gives the same result when repeated, and how strongly patients in the same practice or hospital resemble one another in a cluster randomised trial. One variance ratio sits behind both uses, although the designs and the values regarded as acceptable differ. Shrout and Fleiss showed that different forms of the coefficient can give quite different results from the same data, so a reported value carries little meaning until its form is stated.
A ratio of variance components
The simplest model writes each measurement as an overall mean plus the unit's true departure plus residual noise. Two measurements on the same unit share that departure, and their correlation is the intraclass correlation.
where is the th measurement on unit (a patient in a reliability study, a cluster such as a practice in a trial), is the overall mean, is the departure of unit 's true mean from with variance , is the residual with variance , and is the population intraclass correlation.
Shrout and Fleiss define the intraclass correlation as the correlation between one measurement on a target and another measurement on the same target, which is often, but not always, the target variance divided by the sum of it and other variance components. Terwee and colleagues describe reliability coefficients for health status questionnaires in the same way, as variation between patients over total variation. The value is 0 when units do not differ beyond noise and approaches 1 as within-unit variation shrinks. The same parameter appears as the common correlation in an exchangeable correlation structure.
With measurements on each of units, a one-way analysis of variance gives the estimator below.
where is the between-units mean square on degrees of freedom, is the within-unit mean square on degrees of freedom and is the number of measurements per unit. Shrout and Fleiss note that it is biased, and that applying it to two-way data tends to underestimate the true correlation. Whenever falls below the estimate is negative, a chance result when the true value is near zero.
Six forms for rating and repeat-measurement studies
Reliability studies usually have the same raters or occasions for every patient, which allows a two-way analysis that separates systematic differences between raters or occasions from residual error. Shrout and Fleiss frame the choice as three decisions, whether a one-way or two-way analysis fits the design, whether differences between raters' mean levels count against reliability, and whether the unit of analysis is a single rating or the mean of several.
where is the mean square between raters or occasions on degrees of freedom, is the residual mean square on degrees of freedom, is the number of patients, and and are as before. ICC(2,1) treats raters as a random sample and counts their systematic differences as error, so it measures absolute agreement. ICC(3,1) treats the raters as the only ones of interest and ignores mean differences, so Shrout and Fleiss interpret it as consistency rather than agreement.
The average-measure forms give the reliability of a mean of ratings, which is higher than that of a single rating whenever the single-rating value is positive. Shrout and Fleiss give ICC(1,k) as and, where the rater by target interaction can be assumed absent, ICC(3,k) as , and note that ICC(3,k) is equivalent to Cronbach's alpha, the usual index of internal consistency reliability. In their example of four judges rating six targets, the six forms ranged from 0.17 for ICC(1,1) to 0.91 for ICC(3,4).
Koo and Li set out the ten forms defined by McGraw and Wong, classified by model, by type (single or mean measurement) and by definition (consistency or absolute agreement), with the six Shrout and Fleiss forms as a subset. They note that two-way random and mixed models with the same definition share one formula, so a mixed model with absolute agreement is computed as ICC(2,1). Terwee and colleagues prefer the agreement form, ICC(A,1) in McGraw and Wong's notation, for health status questionnaires because systematic differences are part of measurement error.
Choosing the form for utility and outcome measurement
In economic evaluation the coefficient is used to judge whether an outcome measure behind quality-adjusted life years is stable. For test-retest reliability of a self-completed patient-reported outcome, Koo and Li recommend a two-way mixed-effects model with absolute agreement, because repeated measurements cannot be regarded as randomised samples and measurements would be meaningless without agreement between them. The single-measurement type fits when each patient completes the instrument once.
Devine and colleagues compared EQ-5D responses from 565 care home residents with those of staff proxies, using a one-way random-effects intraclass correlation and adjusting for clustering by care home. Agreement was moderate for index scores (0.44 to 0.50) and for QALYs over one year (0.59, 95% confidence interval 0.50 to 0.67, in 248 pairs), while cluster-adjusted kappa for individual domains ranged from minus 0.03 to 0.26. The authors judged proxies an acceptable source for index scores and QALYs but less reliable for domains. A cost-utility analysis that mixes self-reported and proxy health state utility values therefore carries extra measurement error.
Terwee and colleagues give a positive rating for reliability when the coefficient, or weighted kappa, is at least 0.70 in a sample of at least 50 patients. Koo and Li suggest at least 30 heterogeneous subjects and, where possible, at least 3 raters.
Worked example with repeated utility scores
All numbers in this example are illustrative. Five patients with a stable chronic condition complete a preference-based questionnaire twice, two weeks apart. Their index scores are 0.60, 0.65, 0.70, 0.75 and 0.80 at the first visit and 0.68, 0.65, 0.76, 0.77 and 0.89 at the second. Five patients is too few for a real study but keeps the sums visible.
1. Differences and means. The retest minus test differences are 0.08, 0.00, 0.06, 0.02 and 0.09, with mean 0.05. Patient means are 0.64, 0.65, 0.73, 0.76 and 0.845, and the grand mean is 0.725.
2. Mean squares. The between-patients mean square is . With two occasions, the occasions mean square is , the residual mean square is , and the within-patient mean square is , where 0.0185 is the sum of the squared differences.
3. Three coefficients. Consistency gives ICC(3,1) . Absolute agreement gives ICC(2,1) . The one-way form gives ICC(1,1) . The Pearson correlation between visits is 0.913, close to the consistency value, because it also ignores the average rise of 0.05.
4. Confidence interval. The Shrout and Fleiss interval for ICC(3,1) uses on 4 and 4 degrees of freedom, whose 97.5th percentile is 9.605. Then and , and the 95% interval runs from to .
5. Error in utility units. The two-way variance components are 0.00675 for patients (0.0135 divided by 2), 0.0011 for occasions (0.0055 divided by 5) and 0.00075 for residual error, which reproduce ICC(2,1) . Following de Vet and colleagues, the standard error of measurement is the standard deviation times the square root of one minus the reliability, , and the minimal detectable change is .
6. A more varied sample. If first-visit scores had been 0.50, 0.60, 0.70, 0.80 and 0.90 with the same differences, the between-patients mean square rises to 0.05275 while the other two are unchanged. Agreement becomes ICC(2,1) , yet the standard error of measurement stays 0.043.
7. Interpretation. The coefficient moves with the form and the spread of patients, while the error in utility units does not. A change smaller than about 0.12 in one patient cannot be separated from measurement error. Random error averages out in arm means, but a systematic rise of 0.05 between occasions would appear as a utility gain in any before-and-after comparison.
Clustering in trials and economic evaluation
When the units are clusters, the coefficient describes how much patients in the same practice resemble each other, the cluster effect. The CONSORT extension gives the inflation factor, or design effect, for clusters of size , notes that is typically small (often below 0.05) and only estimated with error after a trial, and asks for a coefficient for each primary outcome to be reported.
The design effect and effective sample size pages carry the conversion further, and a mixed effects model estimates the variance components directly.
Boundaries with nearby statistics
Nearby statistics answer different questions. Terwee and colleagues call the Pearson correlation inadequate for reliability because systematic differences are not taken into account, as the worked example shows.
| Statistic | Data | Relation to the intraclass correlation |
|---|---|---|
| Pearson correlation | Two continuous measures | Ignores mean shifts, behaves like consistency |
| Kappa statistic | Categorical ratings | Quadratic weighted kappa equals the agreement form |
| Cronbach's alpha | Items of one scale | Equivalent to ICC(3,k) |
De Vet and colleagues note that the standard error of measurement gives a number in the same units as the original measurement. The intraclass correlation is unitless and, as step 6 shows, depends on how much patients differ. Reliability assessment covers limits of agreement and related statistics.
Misreadings in reliability and trial reports
Most errors arise from reporting a single number without the design behind it. The same data can make an instrument look excellent or mediocre depending on the form chosen and the spread of patients.
- Not naming the form. Shrout and Fleiss observed that researchers often fail to report which form they used, and Terwee and colleagues found the same in questionnaire studies.
- Judging the point estimate alone. Koo and Li advise reading the 95% confidence interval against their bands (below 0.5 poor, 0.5 to 0.75 moderate, 0.75 to 0.9 good, above 0.9 excellent). The interval of 0.33 to 0.99 in the worked example spans all four.
- Treating reliability as a fixed property of an instrument. Koo and Li note that a low value can reflect a lack of variability among the sampled subjects, as step 6 shows.
- Generalising mean-rating reliability to single raters. Shrout and Fleiss describe a study whose mean ratings over 30 observers had reliability of 0.90 while single ratings had reliability below 0.30.
- Copying a misprinted formula. The 2016 Koo and Li summary table printed the denominator of the one-way single-measure form with where Shrout and Fleiss have , an error the journal corrected in a 2017 erratum.
Sources
- Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661. https://doi.org/10.1136/bmj.e5661
- de Vet HCW, Terwee CB, Ostelo RW, Beckerman H, Knol DL, Bouter LM. Minimal changes in health status questionnaires: distinction between minimally detectable change and minimally important change. Health and Quality of Life Outcomes. 2006;4:54. https://doi.org/10.1186/1477-7525-4-54
- Devine A, Taylor SJC, Spencer A, Diaz-Ordaz K, Eldridge S, Underwood M. The agreement between proxy and self-completed EQ-5D for care home residents was better for index scores than individual domains. Journal of Clinical Epidemiology. 2014;67(9):1035-1043. https://doi.org/10.1016/j.jclinepi.2014.04.005
- Koo TK, Li MY. A guideline of selecting and reporting intraclass correlation coefficients for reliability research. Journal of Chiropractic Medicine. 2016;15(2):155-163. https://doi.org/10.1016/j.jcm.2016.02.012
- Koo TK, Li MY. Erratum to "A guideline of selecting and reporting intraclass correlation coefficients for reliability research". Journal of Chiropractic Medicine. 2017;16(4):346. https://doi.org/10.1016/j.jcm.2017.10.001
- Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychological Bulletin. 1979;86(2):420-428. https://doi.org/10.1037/0033-2909.86.2.420
- Terwee CB, Bot SDM, de Boer MR, van der Windt DAWM, Knol DL, Dekker J, Bouter LM, de Vet HCW. Quality criteria were proposed for measurement properties of health status questionnaires. Journal of Clinical Epidemiology. 2007;60(1):34-42. https://doi.org/10.1016/j.jclinepi.2006.03.012
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Bayesian Methods in Health Economics — Gianluca Baio, 1st Edition ed., 2012 (Chapman & Hall / CRC Press)
An overview of Bayesian statistical methods for the analysis of health economic data, covering economic evaluation concepts, statistical cost-effectiveness analysis, Bayesian computation and MCMC, and applied health economic evaluation.
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Frequently Asked Questions (6)
What is the intraclass correlation?
The intraclass correlation (ICC) is the share of variance in a health outcome lying between patients or clusters, used to judge reliability and clustering.
Source: Shrout & Fleiss 1979
What does the intraclass correlation reveal about clustered data?
In a cluster randomised trial the intraclass correlation shows how much patients in the same practice or hospital resemble one another, expressed as the share of outcome variance lying between clusters rather than within them. A value of zero means patients in the same cluster are no more alike than patients in different clusters, and the value rises towards one as differences within clusters shrink. The CONSORT extension for cluster randomised trials notes that the coefficient is typically small, often below 0.05, and is only estimated with error once a trial is complete. It asks trial reports to give a coefficient for each primary outcome.
Source: Campbell et al. 2012
How is the intraclass correlation calculated?
The intraclass correlation is estimated from the mean squares of an analysis of variance. In the one-way form, the within-unit mean square is subtracted from the between-units mean square, and the result is divided by the between-units mean square plus k minus 1 times the within-unit mean square, where k is the number of measurements on each unit. When the same raters or occasions apply to every patient, a two-way analysis separates systematic differences between raters from residual error and gives separate forms for absolute agreement and for consistency. Shrout and Fleiss showed that these forms can give quite different results from the same data, so the form used should always be stated.
Source: Shrout & Fleiss 1979
What does the intraclass correlation measure?
In measurement studies the intraclass correlation measures reliability, the extent to which patients can be distinguished from each other despite measurement error. Terwee and colleagues describe it as the variation between patients divided by the total variation, so the value is high when patients differ much more than repeated measurements on the same patient do. They prefer the absolute agreement form for health status questionnaires, because systematic differences between occasions or raters count as measurement error, and they regard the Pearson correlation as inadequate for this purpose. A questionnaire receives a positive rating for reliability when the coefficient is at least 0.70 in a sample of at least 50 patients.
Source: Terwee et al. 2007
Why is the intraclass correlation important?
In economic evaluation the intraclass correlation is used to check whether the outcome measures behind quality-adjusted life years give consistent results. Devine and colleagues compared EQ-5D responses from 565 care home residents with those of staff proxies and found moderate agreement for index scores, with cluster-adjusted coefficients of 0.44 to 0.50, and a coefficient of 0.59 for QALYs over one year. Agreement on individual domains was poorer, so the authors judged proxies an acceptable source for index scores and QALYs but less reliable for domains. A cost-utility analysis that mixes self-reported and proxy utility values therefore carries extra measurement error.
Source: Devine et al. 2014
How is the intraclass correlation used in study design?
In a cluster randomised trial, patients in the same cluster share part of their outcome variation, so each additional patient adds less information than in an individually randomised trial. The CONSORT extension gives the resulting inflation factor, or design effect, as one plus the cluster size minus one, multiplied by the intraclass correlation. Even a small coefficient matters when clusters are large, and with 30 patients per practice a coefficient of 0.05 gives a design effect of 2.45. The coefficient is often not known when a trial is planned, which makes the sample size calculation less certain than the formula suggests.
Source: Campbell et al. 2012
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