A proposal for scientific validation of instruments for indirect blood pressure measurement at rest, during exercise, and in critical care.

OBJECTIVE

The purpose of this study was to provide a critical review and comprehensive outline of published guidelines for the validation of monitors for indirect blood pressure (BP) measurement in light of recent research and practical clinical experience.

METHODS

Studies testing the reliability and validity of BP monitors and available guidelines for validation have been reviewed and compared.

RESULTS

The validation studies of instruments for indirect BP measurement have used a wide variety of sample pools, BP ranges, protocols, reference instruments, and statistical procedures, thereby making it impossible to reach a consensus. Few existing recommendations for validation have been found to be incomplete with respect to BP in various physiological states, sequence of procedures, sample, and statistical analysis.

CONCLUSIONS

A new sequence of procedures for validation, including assessment of instruments during exercise and in critical care, is introduced. Previously suggested sample sizes for study subjects, age, and BP groups, as well as margins of error, are statistically challenged. Insufficiency of linear relationship and aggregate agreement alone in determining the interchangeability between a reference and test instrument is demonstrated by quantification of agreement.