Two raters, a yes/no or ordered category, one 2x2 table: get observed agreement, agreement expected by chance, kappa and a 95% interval, with the caveats that decide whether the number means what it seems to.
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Observed agreement
85%
Expected by chance
50%
Cohen’s kappa
0.70
40 events
45 events
5 events
10 events
The short answer
The 2x2 table
Adjudicator A is in the rows and adjudicator B in the columns. The outcome is "primary endpoint event confirmed", yes or no. The numbers are demo data.
| B: yes | B: no | Row total (A) | |
|---|---|---|---|
| A: yes | 40 | 5 | 45 |
| A: no | 10 | 45 | 55 |
| Column total (B) | 50 | 50 | 100 |
Observed agreement pₒ = (40 + 45) / 100 = 0.85. Expected agreement pₑ = (45 × 50 + 55 × 50) / 100² = 0.50. κ = (0.85 − 0.50) / (1 − 0.50) = 0.70.
The calculation
Cohen (1960) proposed kappa for two raters who each assign every subject to one of the same categories. Raw percent agreement overstates reliability because two raters who guess will still agree some of the time. Kappa subtracts that expected agreement: pₑ is the sum, over categories, of the product of the two raters’ marginal proportions. In the table above rater A says "yes" 45% of the time and rater B 50% of the time, so the chance both say yes is 0.45 × 0.50 = 0.225; both say no is 0.55 × 0.50 = 0.275; and pₑ = 0.50. Kappa is 1 for perfect agreement, 0 when agreement is no better than chance, and can go negative when raters disagree more than chance predicts.
The large-sample standard error most online calculators use is SE(κ) = √[pₒ(1 − pₒ) / (n(1 − pₑ)²)]. Here that is √[0.85 × 0.15 / (100 × 0.25)] = 0.0714, so the 95% interval is 0.70 ± 1.96 × 0.0714, or 0.56 to 0.84. The fuller variance of Fleiss, Cohen and Everitt (1969) gives 0.0711 for this table, practically the same. With small samples, rare categories or kappa near 1, the normal approximation is poor, and a statistician may prefer a bootstrap or exact interval. The width matters as much as the point estimate: with 100 events the interval spans roughly "moderate" to "almost perfect" on the usual scale.
Landis and Koch (1977) labelled 0.21 to 0.40 fair, 0.41 to 0.60 moderate, 0.61 to 0.80 substantial and above 0.80 almost perfect. Those labels were an arbitrary convention and have been criticised for being applied as pass/fail thresholds (McHugh, 2012). A kappa of 0.70 is acceptable for a screening flag that a clinician will re-check and may be far too low for a rating that decides primary endpoint status without any second look. Decide the required agreement from the consequence of a disagreement, write it into the adjudication charter or the statistical analysis plan before looking at the data, and judge the lower bound of the interval, not only the point estimate.
The prevalence problem
Both tables have 100 subjects and about 85 to 90% raw agreement. Only the balance between categories changes.
| Table (A rows, B columns) | Counts a / b / c / d | Observed agreement | Expected by chance | Kappa (95% CI) |
|---|---|---|---|---|
| Balanced categories | 40 / 5 / 10 / 45 | 0.85 | 0.50 | 0.70 (0.56 to 0.84) |
| Mostly "no" | 20 / 10 / 5 / 65 | 0.85 | 0.60 | 0.63 (0.45 to 0.80) |
| Mostly "yes" (rare "no") | 85 / 5 / 5 / 5 | 0.90 | 0.82 | 0.44 (0.12 to 0.77) |
The third row has the highest raw agreement and the lowest kappa, because 82% agreement is expected by chance when 90% of subjects are "yes" for both raters. Byrt, Bishop and Carlin (1993) describe this prevalence and bias effect; the prevalence-adjusted bias-adjusted kappa (PABAK = 2pₒ − 1, here 0.80) is sometimes reported beside kappa, but it is debated and does not replace showing the table.
Ordered categories
When categories are ordered (none, mild, moderate, severe), a disagreement between "mild" and "severe" is worse than one between "mild" and "moderate". Weighted kappa (Cohen, 1968) gives partial credit: with linear weights the credit for a disagreement is 1 minus the distance between categories divided by the maximum distance, and with quadratic weights it is 1 minus the squared relative distance. Take 70 subjects rated mild, moderate or severe by two raters with the counts 20, 5, 0 / 4, 15, 6 / 1, 3, 16 (rows rater A, columns rater B). Unweighted kappa is 0.59, linear-weighted kappa is 0.68 and quadratic-weighted kappa is 0.76. The statistic you report must be the one named in the analysis plan, with the weighting scheme stated, because the choice alone moved the result by 0.17.
Kappa is defined for two raters rating every subject. With three or more raters, Fleiss’ kappa (1971) generalises it, and if the raters differ between subjects a different statistic (Krippendorff’s alpha, for example) may fit better. For measurements on a continuous scale, such as a blood pressure read by three nurses or a tumour diameter measured by two radiologists, dichotomising to compute kappa throws away information. The intraclass correlation does the right job there, and the ICC calculator works through Shrout and Fleiss forms with a numerical example.
Plan the agreement study as carefully as the trial. The standard error formula above can be turned around: to estimate a kappa near 0.70 with chance agreement near 0.50 to within ±0.10 at 95% confidence, you need about 196 subjects rated by both raters; ±0.15 needs about 87, and ±0.05 needs about 784. Those figures assume a balanced table, and a rarer category needs more. Before the real ratings start, run a calibration set of cases, discuss the disagreements, tighten the written definition and only then collect the ratings that will be reported. Record who the raters are and their training, because a kappa from two experienced readers does not transfer to a pool of new ones. State in the charter how a disagreement is resolved (a third reviewer, a consensus meeting) and report the agreement before the tie-break, since the resolved value is by construction in perfect agreement.
Where kappa appears in trials
Two independent reviewers decide whether an event meets the protocol definition (stroke, hospitalisation, radiographic progression). Agreement before a tie-break is reported in the adjudication charter or the paper.
Read more Phase 1 to 3Two reviewers check whether a screened candidate meets a subjective inclusion criterion. A kappa on a pilot batch shows whether the criterion wording is clear enough to apply across sites.
Read more SafetyInvestigator and sponsor medical monitor each classify relatedness. Ordered categories (unrelated, possible, probable, definite) suit weighted kappa, with a pre-specified weighting.
Read moreBuild the eCRFs, edit checks and visit schedule in the free sandbox with every feature. No credit card, no time limit. You pay only when you go live with real participants.
Collecting the ratings
Agreement statistics are only as good as the independence of the ratings. Build the rating as its own eCRF form with single-choice fields for the category and a free-text field for the reasoning, completed separately by each rater, with the independence written into the adjudication procedure. In Capture, forms follow a draft-to-approved lifecycle, so the rating form is locked once approved and both raters use the same version, and role-based access separates site, researcher and admin permissions. Every entry carries a field-level audit trail with user, timestamp, old value, new value and reason for change, which lets you check the timestamps and show later whether a rating was edited after the other rater’s call was entered.
The ratings export as CSV or Excel in wide format with a data dictionary, one row per submission, so the two raters’ category columns can be tabulated into the 2x2 table above without reshaping. Edit checks keep the data clean at entry: a required single-choice field prevents blanks, and a custom rule can raise an auto-query when a free-text justification is missing for a "yes". For safety data, the same pattern fits the adverse event reporting workflow and the AE eCRF template. Kappa itself is computed in your statistical software or the table above; Capture supplies the clean, audit-trailed inputs. For diagnostic studies where agreement between readers is itself an outcome, see EDC for diagnostic accuracy studies.
Decision rule
Cohen’s kappa on the 2x2 table. Report the table, pₒ, kappa and the 95% interval.
Weighted kappa with the weights named in the SAP (linear or quadratic), plus the unweighted value for transparency.
Fleiss’ kappa, or ask the statistician about Krippendorff’s alpha if raters differ by subject.
Intraclass correlation (see the ICC calculator), not kappa on a dichotomised version.
Show the table and the prevalence-adjusted figure beside kappa; do not rely on kappa alone.
Fix it before the data are seen, from the cost of a disagreement, and judge the lower interval bound.
It is a chance-corrected measure of agreement between two raters who classify the same subjects into categories. It equals (observed agreement − expected agreement) / (1 − expected agreement), where expected agreement comes from each rater’s own category totals.
With cells a (both yes), b, c and d (both no) and n = a + b + c + d: pₒ = (a + d) / n; pₑ = [(a + b)(a + c) + (c + d)(b + d)] / n²; κ = (pₒ − pₑ) / (1 − pₑ). In the worked example 40, 5, 10, 45 gives pₒ 0.85, pₑ 0.50 and κ 0.70.
The common Landis and Koch labels call 0.61 to 0.80 substantial and above 0.80 almost perfect, but those labels are a convention, not a standard. What is good enough depends on how costly a disagreement is, so set the target in advance and judge the lower bound of the confidence interval. Confirm the target with a statistician.
Kappa is penalised when one category dominates, because most of the agreement is then expected by chance. With 90% of subjects "yes" for both raters, expected agreement is 82%, and 90% observed agreement gives kappa 0.44. Report the 2x2 table and consider the prevalence-adjusted measure alongside.
When the categories are ordered and some disagreements are worse than others, such as a mild-versus-severe split compared with a mild-versus-moderate one. Linear weights give partial credit in proportion to distance and quadratic weights penalise large gaps more. State the scheme in the analysis plan; in the example it moved kappa from 0.59 to 0.68 to 0.76.
Kappa is for categorical ratings; the intraclass correlation is for continuous measurements and compares between-subject variance with rater and error variance. Use kappa for yes/no or graded categories, ICC for quantities such as blood pressure or a diameter.
Not Cohen’s version. Fleiss’ kappa extends the idea to three or more raters when every subject is rated by the same number of raters. Other statistics, such as Krippendorff’s alpha, handle missing ratings and different raters per subject. A statistician should choose.
Capture collects each rater’s classification as separate, audit-trailed eCRF entries and exports them to CSV or Excel with a data dictionary. The kappa itself is calculated from that export, using the table on this page or your statistical software. This page is a planning aid, not validated software.
Keep exploring
ICC calculator
Agreement for continuous measurements.
Relative risk and odds ratio calculator
Another 2x2 table calculation.
AE causality assessment
Ordered relatedness categories.
EDC for diagnostic accuracy studies
Reader agreement as an outcome.
Clinical trial endpoints
What adjudication decides.
EDC for Phase 3 clinical trials
Running adjudicated endpoints at scale.
Build the eCRFs, edit checks and visit schedule in the free sandbox with every feature. No credit card, no time limit. You pay only when you go live with real participants.