Intraclass correlation in practice: Assessment of reliability of manual blood pressure measurement among assessors in a clinical trial

Abstract

Background : To ensure the reliability of manual blood pressure (BP) readings in a clinical trial, sources of error due to measurement must be reduced as much as possible. Apart from following standard procedure for BP measurement and ensuring good equipments, the measurement errors that come from the assessors themselves should be assessed. Objective : To demonstrate the use of two-way random effects, interactions absent, absolute agreement (Type A), single measures (Type 1) intraclass correlation coefficient (ICC) in the assessment of reliability of manual BP readings among assessors involved in a clinical trial using manual BP measurement, by using an interrater reliability study conducted by the authors as an example study. Methods : The steps involved in obtaining ICC in the study were discussed. Sample size given the number of assessors in the study was calculated. BP was measured using regularly maintained mercury sphygnomanometers, following recommendations by Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) for BP measurement in office setting. The outcomes were systolic and diastolic BP readings. A type of ICC, two-way random effects, interactions absent, absolute agreement (Type A), single measures (Type 1) ICC was chosen for the analysis and specifically discussed. Pre-requisite assumptions for ICC were meticulously checked and described. The interrater reliability for systolic and diastolic BP readings as expressed by ICC (single measure) were presented with confidence interval (CI). The ICCs obtained in the example study were discussed and concluded. The flaws of the study were also criticised. Results : The interrater reliability for systolic and diastolic BP measurements as expressed by ICC (single measure) were 0.87 (95% confidence interval [CI] 0.722, 0.956) and 0.77 (95% CI 0.560, 0.918) respectively. Conclusion : We demonstrated the steps required to obtain ICC. Since the use of manual BP measurement using mercury sphygmomanometer is still considered as gold standard of BP measurement, it is important that studies in which the BP outcome is measured using such method conduct interrater reliability studies properly.