Abstract

Problem statement: Reliability studies are concerned with the study o f consistency or repeatability of measurements. Often times (but n ot always) the reliability coefficients are Intra-c lass Correlation Coefficients (ICC). Depending on the de sign or the conceptual intent of the study there ar e three types of intra-class correlation coefficients , termed intra-class correlation coefficients Case 1, 2 and 3, for measuring the reliability of a single in terval measure. While methods for sample size calculations for intra-class correlation coefficien ts in Case 1 are available and implemented in Power Analysis and Sample Size System (PASS); to our knowledge, no methods based on intra-class correlation coefficients in Case 2 and 3 are availa ble. Objective: Develop a method for calculating the size of a reliability study based on intra-class co rrelation coefficients Case 1 and 2. Approach: A practical method for computing sample size using si mulations was proposed. We proposed to compute sample size based on the expected width of the conf idence interval. For a given target value of the intra-class correlation coefficient, the proposed m ethod chooses the design assures a 95% confidence interval with average length shorter than a pre-spe cified value. The applicability of the proposed method in practice for intra-class coefficients Cas e 2 was supported by demonstrating three invariance properties of the proposed confidence intervals. Results: Tables with sample size requirements were derived and displayed. A program for carrying out t he calculations was developed in R. The method was used to size a trial aimed to study the reliabi lity of a scale that measures the cleanness of the colon at the time of colonoscopy. Conclusion: A simple method for sample size calculation for int ra-class correlation coefficient Case 1 and 2 based on the a verage length of confidence intervals was proposed. The proposed was implemented by the authors in R (freely available software). Three invariance properties of the confidence intervals for the intr a-class correlation coefficients Case 2 were studie d by simulations. These properties are an important tool when considering the design of this type of studie s.

Highlights

  • Intra-class correlation coefficients are commonly used in epidemiology, psychology, sociology and medicine as reliability coefficients

  • While methods for sample size calculations for intraclass correlation coefficients in Case 1 are available and implemented in PASS (Power Analysis and Sample Size System) (Walter et al, 1998; Winer, 1991); to our knowledge, no methods based on intra-class correlation coefficients in Case 2 and 3 are available

  • In this study we propose a method for calculating the size of a study based on confidence intervals of intra-class correlation coefficients

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Summary

INTRODUCTION

Intra-class correlation coefficients are commonly used in epidemiology, psychology, sociology and medicine as reliability coefficients. In this study we propose a method for calculating the size of a study based on confidence intervals of intra-class correlation coefficients. Sample size calculations based on ICC(2,1): In reliability studies, the main aim is not testing but accurate estimation. For this reason sample size calculations should focus on precision rather than power (Beal, 1989; Daly, 1991; Greenland, 1988). The confidence interval can be expressed as: recommended that in the analysis of data, confidence intervals be used rather than hypothesis tests whenever confidence intervals are warranted In spite of this shift in the presentation of the data many studies continue to use power or minimal detectable difference as the criteria for sample size calculations. Many authors agree that when the main aim of the study is estimation the average length of the confidence

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