title: Lax sphygmomanometer standard causes overdetection and underdetection of hypertension: a computer simulation study.
abstract: OBJECTIVE
  To quantify overdetection and underdetection of hypertension caused by systematic sphygmomanometer errors permitted by the current European standard (EN 1060 'noninvasive sphygmomanometers').
  
  
  METHODS
  We carried out Monte Carlo simulation of measurement of blood pressure (BP) of the adult Australian population using sphygmomanometers showing systematic errors compliant with the EN 1060 standard. We repeated the simulations limiting systematic sphygmomanometer errors to +/-1 mmHg. Simulated BP measurements included systematic sphygmomanometer error, random intraindividual BP variability and random measurement error.
  
  
  RESULTS
  After three visits, underdetection of hypertension is common owing to variability of BP measurements and systematic errors of sphygmomanometers. After three visits, the wide tolerances of EN 1060 are responsible for approximately 4.9 and 11% of underdetection of systolic and diastolic hypertension, respectively. Underdetection is worse in some groups, for example, permitted sphygmomanometer error causes 20% of all undetected systolic hypertension in 18-24 year-old women. The current standard also results in overdetection of hypertension. Permitted sphygmomanometer error causes 5.8 and 14% of the overdetection of systolic and diastolic hypertension, respectively, after three visits. Overdetection is worse in some groups, for example, after three visits, permitted sphygmomanometer error causes 19% of falsely detected diastolic hypertension in 18-24 year-old men. For all adults, reduction of permitted sphygmomanometer error to +/-1 mmHg achieves approximately the same improvement in hypertension detection as at least one additional visit to the clinician.
  
  
  CONCLUSIONS
  Systematic sphygmomanometer errors permitted by the current standard are a preventable cause of clinically significant overdetection and underdetection of hypertension. The standard should be revised to make the effects of equipment related systematic errors negligible compared with the effects of physiological variability.
authors.affiliation: Department of Anaesthetics, School of Public Health, University of Sydney, Sydney, Australia. mjturner@usyd.edu.au
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Turner
authors.forename: Johan M
authors.initials: JM
authors.lastname: van Schalkwyk
authors.forename: Les
authors.initials: L
authors.lastname: Irwig
mesh_terms: D000293:Adolescent; D000328:Adult; D001795:Blood Pressure Determination / Q000295:instrumentation*; D003198:Computer Simulation; D003951:Diagnostic Errors; D004868:Equipment Failure; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis*; D008297:Male; D009010:Monte Carlo Method; D015203:Reproducibility of Results