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Clinical practice involves measuring quantities for a variety of purposes, such as aiding diagnosis, predicting future patient outcomes, and serving as endpoints in studies or randomized trials. Measurements are almost always prone to various sorts of errors, which cause the measured value to differ from the true value; accordingly, studies investigating measurement error frequently appear in this and other journals. The importance of measurement error depends upon the context in which the measurements in question are to be used. For example, a certain degree of measurement error may be acceptable if measurements are to be used as an outcome in a comparative study such as a clinical trial, but the same measurement errors may be unacceptably large to make measurements usable in individual patient management, such as screening or risk prediction. In the past 20 years many papers have been published advocating how studies of measurement error should be analyzed, with a paper by Bland and Altman1 being one of the most cited and well known examples. There has been much controversy concerning the choice of parameter to be estimated and reported, and consequently confusion surrounding the meaning and interpretation of results from studies investigating measurement error. In this paper we first distinguish between the general concepts of agreement and reliability to aid researchers in considering which are relevant for their particular application. We then review the statistical methods that can be used to investigate and quantify agreement and reliability, dealing separately with the different types of measurement error study, while emphasizing the largely common techniques that should be used for data analysis. We reiterate that the judgment of whether agreement or reliability are acceptable must be related to the clinical application, and cannot be proven by a statistical test. We highlight the fact that reliability depends on the population in which measurements are made, and not just on the measurement errors of the measurement method. We discuss the advantages of method comparison studies making at least two measurements with each measurement method on each subject. A key advantage is that the cause of a correlation between paired differences and means in the so-called Bland–Altman plot can be determined, in contrast to when only a single measurement is made with each method. Throughout the paper, we try to emphasize that calculated values of agreement and reliability from measurement error studies are estimates of parameters, and as such we should report such estimates with CIs to indicate the uncertainty with which they have been estimated. We restrict our attention to measurements of a continuous quantity; alternative methods are required for categorical data2. One difficulty in the measurement error field is the number of different terms used to describe studies of measurement error. The terms 'agreement', 'reliability', 'reproducibility' and 'repeatability' are used with varying degrees of consistency in the medical literature. We first make clear the distinction between the statistical concepts of agreement and reliability3. Agreement quantifies how close two measurements made on the same subject are, and is measured on the same scale as the measurements themselves. Two measurements of the same subject may differ for a number of reasons, depending on the conditions under which the measurements were made. In a method comparison study there will be differences because of inherent variability in each of the measurement methods, as well as potentially a bias between the measurements from the methods. If the measurements are made by different observers or raters, differences may be due to biases between the observers. Agreement between measurements is a characteristic of the measurement method(s) involved, which does not depend on the population in which measurements are made, unless bias or measurement precision varies with the true value being measured. One popular way of quantifying agreement is to estimate the 95% limits of agreement, as proposed by Bland and Altman1. These limits are defined such that we expect that, in the long run, 95% of future differences between measurements made on the same subject will lie within the limits. If reliability is high, measurement errors are small in comparison to the true differences between subjects, so that subjects can be relatively well distinguished (in terms of the quantity being measured) on the basis of the error-prone measurements. Conversely, if measurement errors tend to be large compared with the true differences between subjects, reliability will be low because differences between measurements of two subjects could be due purely to error rather than to a genuine difference in their true values. The reliability parameter is also known as an intraclass correlation (ICC), as it equals the correlation between any two measurements made on the same subject. Reliability takes values between zero and one, with a value of one corresponding to zero measurement error and a value of zero meaning that all the variability in measurements is due to measurement error. As a dimensionless quantity, it is arguably quite difficult to interpret, and deciding what value constitutes sufficiently high reliability is often made in a subjective fashion. Repeatability of measurements refers to the variation in repeat measurements made on the same subject under identical conditions4. This means that measurements are made by the same instrument or method, the same observer (or rater) if human input is required, and that the measurements are made over a short period of time, over which the underlying value can be considered to be constant. Variability in measurements made on the same subject in a repeatability study can then be ascribed only to errors due to the measurement process itself. Reproducibility refers to the variation in measurements made on a subject under changing conditions4. The changing conditions may be due to different measurement methods or instruments being used, measurements being made by different observers or raters, or measurements being made over a period of time, within which the 'error-free' level of the variable could undergo non-negligible change. The first type of study we consider is a repeatability study, in which we investigate and quantify the repeatability of measurements made by a single instrument or method, and in which the conditions of measurement remain constant. The second type of study we consider is a method comparison study, in which measurements are made using two measurement methods on a sample of subjects. The use of two different methods means that this is a reproducibility study, but the term method comparison is used as it clearly communicates the changing conditions under which measurements have been made. In contrast to a repeatability study, systematic bias may exist between measurements made by two different methods, and their measurement errors may have different SDs. The last type of study we consider is one in which measurements are made by different observers or raters. Again this is a type of reproducibility study. As with method comparison studies, biases may exist between observers, and their measurement SDs may differ. As we discuss below (see Measurements with observers or raters), if interest lies in quantifying the measurement error characteristics of the particular observers in one's study, exactly the same analysis methods should be used as for a method comparison study. In order to investigate the repeatability of measurements, a repeatability study must, for an appropriately selected sample, make at least two measurements per subject under identical conditions. This means that the measurements must be made by the same measurement method, or the same observer or rater. The objective is to then quantify the agreement and reliability of measurements made by that particular method or observer. If the differences between two measurements made on a subject are approximately Normally distributed, in the long run we expect the absolute difference between two measurements on a subject to differ by no more than the repeatability coefficient on 95% of occasions. To estimate the within-subject SD, we can fit a one-way analysis of variance (ANOVA) model to the data containing the repeat measurements made on subjects. ANOVAs can be fitted in all modern statistical packages. ANOVA models partition variability in data into that which can be ascribed to differences between groups, and that remaining to within groups. For a repeatability study, the groups are defined by the subjects under measurement, and this must be specified in the statistical package used. The ANOVA model estimates how much variation in measurements can be attributed to differences in the true, or 'error-free' values of subjects, with the remainder constituting measurement error. Fitting the ANOVA model results in estimates of the between-subject and within-subject SDs (or alternatively the corresponding variances, which are the SDs squared). The estimate of the within-subject SD can be used in the above formula to give an estimate of the repeatability coefficient. We illustrate with a study by Järvelä et al., who investigated the repeatability of measurements of flow volume made by one observer using three-dimensional (3D) power Doppler ultrasonography from 22 ovaries5. The estimated repeatability coefficient was 3.97, meaning that the absolute difference between any two future measurements made by that particular observer on a particular subject/unit are estimated to be no greater than 3.97 on 95% of occasions. It is important to note that the repeatability of another observer may be different, because of differences in the training and ability of observers. Because the repeatability coefficient calculated is an estimate, it is important to calculate a CI for it to indicate how precisely it has been estimated. A CI may be given automatically by statistical software, but in the Appendix we review how a 95% CI for the within-subject SD can be calculated. Such a CI can be used to find a CI for the repeatability coefficient by multiplying the CI limits by . If the CI for the within-subject variance is given by software instead, the limits must first be square rooted to give a CI for the within-subject SD. The ANOVA model assumes that the measurement errors are statistically independent of the true 'error-free' value, and that the SD of the errors is constant throughout the range of 'error-free' values. Sometimes the SD of errors increases with the true value being measured. This should be checked by plotting paired differences between measurements against their mean, the so called Bland–Altman plot. We illustrate this later in the context of a method comparison study (see Plotting the data) and describe how such heterogeneous errors can often be with by making a (see variability in measurement of the repeatability coefficient on the differences between measurements being approximately Normally This can be checked by a or plot of the paired differences in measurements on each subject. made in the of the CI for the within-subject SD is that the measurement errors are If this is in the may be to The reliability of a measurement method is often of interest when measurements are to be used to between subjects or groups of subjects. For example, if we have a choice of two measurement methods that could be used to an outcome in a clinical or study, using the method with reliability will give greater statistical power to differences between groups, for a given sample In this we describe how measurements from a single method can be used to estimate the reliability in a given we discuss the use of reliability to measurement methods (see Reliability in method comparison and different observers (see in The same ANOVA model as above (see can be used to estimate statistical will automatically give the estimated which is the of we can the estimates of the and within-subject SDs into the formula given above (see Agreement and to estimate the For the flow data of Järvelä et an estimated of was This means that of the variability in measurements of the flow was estimated to be due to genuine differences in flow between with the remaining being due to errors in the measurement process and the observer Because the measurements were all made by one the reliability may be to as As with the repeatability the calculated is an estimate, and a 95% CI should be statistical give a but in the Appendix we review the of a 95% CI for the For the flow data of Järvelä et the estimate of a 95% of to Because we use the same ANOVA model to estimate reliability as we describe for agreement, the same of 95% CIs for the estimate on of the true 'error-free' values. The reliability of a measurement method depends upon the of the population in which the measurements are made. the of reliability given above (see Agreement and we that the of true 'error-free' values in the measured by the between-subject SD, the value of agreement between repeat measurements is a characteristic of the method or instrument the of measurement errors is the range of true reliability depends on the of measurement errors and the true in the population in which measurements are made. The is with a a method for measuring has a within-subject SD of which does not with the underlying value being measured. we a study to estimate the reliability, and we sample from a heterogeneous population in which the between-subject SD in true is 20 This give a reliability or of . we sample our subjects from a more in which the SD of true values is the same as the variability of the within-subject error. In this the reliability is to . If studies report only an estimate of the reliability (ICC), can only make use of the estimate if the population in which the to use such measurements has We that report estimates of and within-subject SD, in to the In this can whether the measurement method will be sufficiently for their application, in which the between subjects may be we use a measurement method or in clinical we must that the measurements it are to by the measurement method used, that measurements made with the method are using the method. If the measurements from the two methods are sufficiently close and the of a patient on their basis be the the method could the method in clinical because the method is or to The as to what constitutes depends on how the measurements are to be used. If the two measurements are made on the same or we can quantify their To investigate and quantify the agreement between measurements made by two methods, we must at a a sample of subjects using the measurement method and the proposed method. The data from such a study of of measurements from each with the containing the measurements from the two measurement methods. we making two measurements on each subject using each method because the one measurement per method is the most common we by analysis. The first to such a is to plot the The plot is of measurements from the method against from the method (or If measurements were from we expect the to lie on the of the of can be used to if there is if more data are above the than this that the method on the measurements on the of fit for this plot and report a statistical for whether the of the plot from the of As by Bland and in a paper in this we expect the to have a than one if the method on the any measurement and so a of the that the true is to one is not a it the same as a plot with the of of the between the measurements from two methods is often more by plotting the difference in a measurements from the two methods against the of their measurements, as first by and this is to as the Bland–Altman and is frequently in of measurement error We illustrate the plot using an from the literature. et volume measurement in with and volume was measured using and also by We have approximately their plot of differences against means and it is as using only data from the in volume measured by three-dimensional and by against their from study by et the SD and the SD, each with 95% CI The plot the difference between calculated using and against the of two values. et not their plot or of results to indicate which measurements were from It is important to be and always the same measurement from the The the of the paired from zero an estimate of the bias between the two methods. which measurements have been from which to which method, on measurements. The indicate the estimated limits of agreement their CI which we describe The plot can be used to the differences between measurements made by the two methods. The variability of the differences between the two methods how well the methods If the variability of the paired differences is the range of measurements, and there is no between the difference and mean, we can quantify the agreement between the methods by the limits of the of the limits of agreement, we illustrate how the for limits of agreement may be and how they can be on we expect the difference in volume as measured by the two methods to lie between and for 95% of future measurements. It is important to that the limits of agreement calculated in this are just and as with any type of estimate it is to quantify and report how precisely the limits are estimated of 95% The estimated limits of agreement indicate how large the between the measurements will be on 95% of occasions. The whether the methods sufficiently well must then be made depending on the context in which the measurements will be used. In contrast to the repeatability which assumes no bias between measurements, the limits of agreement method this The of the paired differences whether on one method to or measurements to the measurements of the second method, which we to as a bias between the methods. In the data in from et al., there was of a bias between the two methods, because the difference between the methods was close to at We can a statistical to whether there is of bias by a of the differences paired of the measurements from each we the that the true of the differences is corresponding to no bias between the methods. For the data in this that there was no of a bias between and made using The limits of agreement method assumes that the SD of the differences is throughout the range of measurements. 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