Task Force I: methodological aspects of blood pressure measurement.
OBJECTIVE
To reach a consensus on important methodological aspects of blood pressure measurement.


METHODS
A Task Force on the methodological aspects of blood pressure measurement wrote this review after the Eighth International Consensus Conference on Blood Pressure Monitoring, in Sendai, Japan (28-31 October 2001). This consensus paper is based on the papers presented by Task Force I and on the discussion sessions, and is therefore representative of a broad spectrum of expert opinion.


CONCLUSIONS
Consensus was reached on the following five issues: (1) there is an urgent need for a simplified protocol for the validation of blood pressure measuring devices; (2) there is a need for a means of updating the "state of the market" for validated devices so that users can have easy access to this information; (3) new devices must be validated independently, and existing devices that have not been validated must be reappraised; (4) manufacturers should confirm when new models use algorithms which have been validated previously; (5) the Food and Drug Administration now accepts that when ambulatory blood pressure measurement is used in clinical short-term trials in which side-effects are not being assessed, a placebo arm is not required.
O'Brien
E
E
Blood Pressure Unit, Beaumont Hospital, Dublin, Ireland. eobrien@iol.ie
van Montfrans
G
G
Palatini
P
P
Tochikubo
O
O
Staessen
J
J
Shirasaki
O
O
Lipicky
R
R
Myers
M
M
D000465:Algorithms; D001795:Blood Pressure Determination / Q000295:instrumentation* / Q000379:methods; D002985:Clinical Protocols; D018795:Device Approval / Q000592:standards; D019544:Equipment Failure Analysis / Q000379:methods / Q000592:standards; D006801:Humans; D033181:Information Dissemination