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Sphygmomanometers for Clinical Use Self Blood Pressure Measurement Ambulatory Blood Pressure Measurement Protocols & Standards General Papers relating to Blood Pressure Measurement

Protocols and Standards

Validation Protocols
Commentary on Protocols
Methodology of Validation Protocols
Sphygmomanometer Standards
Simulators
Device Equivalence

Validation Protocols

International Protocol of the European Society of Hypertension
O’Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; on behalf of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. European Society of Hypertension International Protocol revision 2010 for the Validation of Blood Pressure Measuring Devices In Adults. Blood Press Monit 2010;15:23–38.
 
O'Brien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J, Mengden T, Imai Y, Waeber B, Palatini P with the statistical assistance of Atkins N and Gerin W on behalf of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. International protocol for validation of blood pressure measuring devices in adults. Blood Press Monit 2002;7:3-17
 
British Hypertension Society
O'Brien E, Petrie J, Littler WA, de Swiet M, Padfield PL, Altman D, Bland M, Coats A, Atkins N.  The British Hypertension Society Protocol for the evaluation of blood pressure measuring devices.  J Hypertens 1993;11(suppl 2):S43-S63.
 
O'Brien E, Petrie J, Littler WA, de Swiet M, Padfield PL, Altman D, Bland M, Coats A, Atkins N.  Short report. An outline of the British Hypertension Society Protocol for the evaluation of blood pressure measuring devices.  J Hypertens 1993;11:677-679.
 
O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O'Malley K, Jamieson M, Altman D, Bland M, Atkins N.  The British Hypertension Society Protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems.  J Hypertens 1990;8:607-619.
 
O'Brien E, Petrie J, Littler W, De Swiet M, Padfield P, O'Malley K, Jamieson MJ, Altman  D, Bland M, Atkins N.  The Britisih Hypertension Society protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems.  J Ambulatory Monitoring 1991;4:207-228.
 
O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O'Malley K, Jamieson M, Altman D, Bland M, Atkins N.  The British Hypertension Society Protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems.  In Blood Pressure Measurement. Eds. E. O'Brien and K. O'Malley.   HANDBOOK OF HYPERTENSION. Eds.  W.H.Birkenhager and J.L.Reid.  Elsevier. Amsterdam. 1991. pp.  430-451
 
Association for the Advancement of Medical Instrumentation (America)
Association for the Advancement of Medical Instrumentation. American National Standard. Manual, electronic or automated sphygmomanometers ANSI/AAMI SP10-2002/A1. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI; 2003.
 
Association for the Advancement of Medical Instrumentation. American National Standard. Manual, electronic or automated sphygmomanometers ANSI/AAMI SP10-2002. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI; 2003.
 
Association for the Advancement of Medical Instrumentation. American National Standard. Electronic or automated sphygmomanometers ANSI/AAMI SP10-1992/A1. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI; 1996.
 
Association for the Advancement of Medical Instrumentation. American National Standard. Electronic or automated sphygmomanometers ANSI/AAMI SP10-1992. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI; 1993.
 
Association for the Advancement of Medical Instrumentation. American National Standard. Electronic or automated sphygmomanometers ANSI/AAMI SP10-1987. 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598, USA: AAMI; 1987.
 
Other Protocols
Normenausschuß Feinmechanik und Optik (NaFuO) im DIN Deutsches Institut für Normierung e V: Non-invasive sphygmomanometers - Clinical Investigation. Berlin: Beuth Verlag; 1996
 

Commentary on Protocols

O'Brien E, Atkins N. A comparison of the BHS and AAMI protocols for validating blood pressure measuring devices:  can the two be reconciled?  J Hypertension 1994; 12:1089-1094
 
O'Brien E. Towards improving procedures for validating blood pressure measuring devices. Blood Pressure Monitoring 1997;2:247-249
 
O'Brien E. Criteria for validation of devices. Task Force I: Methodological aspects. Blood Pressure Monit 1999;4:279-281
 
O'Brien E. Methods of analysis. Task Force I: Methodological aspects. Blood Pressure Monit 1999;4:286-287
 
O'Brien E. Modification of blood-pressure measuring devices and the protocol of the British Hypertension Society. Blood Pressure Monit 1999;4:53-54
 
O'Brien E. Validation Up-date. Blood Press Monit 2001;6:275-280
 
O'Brien E and Atkins N on behalf of the Working Group of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. The "International Protocol": More Insight or More Arithmetic? J Blood Pressure Monit 2002;5:290-291
 

Methodology of Validation Protocols

Atkins N, O'Brien E, Mee F, O'Malley K.  The relative accuracy of simultaneous same arm, simultaneous opposite arm and sequential same arm measurements in the validation of automated blood pressure measuring devices.  J Human Hypertens 1990;4:647-649.
 
O'Brien E, Mee F, Atkins N, O'Malley K, Tan S.  Training and assessment of observers for blood pressure measurement in hypertension research.  J Human Hypertension  1991;5:7-10
 
O'Brien E, Atkins N, Mee F, Coyle D, Syed S. A new audio-visual technique for recording blood pressure in research:  the Sphygmocorder. J Hypertens 1995;13:1734-1737.
 
Atkins N, O'Brien E, Wesseling KH, Guelen I. Increasing observer objectivity with audio-visual technology: the Sphygmocorder. Blood Pressure Monitoring 1997;2:269-272
 

Sphygmomanometer Standards

Turner a MJ , Irwig b L , Alexandra J. Bune c AJ , Kam a PC, Baker a AB. Lack of sphygmomanometer calibration causes over- and under-detection of hypertension: a computer simulation study J Hypertens 2006;24:1931-1938
 
Parati a G , Faini a A, Castiglioni c P. Accuracy of blood pressure measurement: sphygmomanometer calibration and beyond J Hypertens 2006;24:1915-1918
 
O'Brien E, Petrie JC, Littler WA, deSwiet M.  Standards for Blood Pressure Measuring Devices.  Br Med J 1987;244:1245-1246.
 
Specification for Aneroid and Mercury non-automated sphygmomanometers. BS 2743:1990.  British Standards Institiution. London 1990.
 
CMS. Centers for Medicare & Medicaid Services. Medicare Coverage Policy ~ Decisions. ABPM Monitoring (#CAG-00067N). 2001.
 
European Standard EN 1060-1 (British Standard BSSEN 1060-1:1996). Specification for Non-invasive sphygmomanometers. Part I. General requirements. 1995. European Commission for Standardisation. Rue Stassart 36, B-1050 Brussels.
 
European Standard EN 1060-2 (British Standard BSSEN 1060-2:1996). Specification for Non-invasive sphygmomanometers. Part 2. Supplementary requirements for mechanical sphygmomanometers. 1995. European Commission for Standardisation. Rue Stassart 36, B-1050 Brussels.
 
Non-invasive sphygmomanometers. Part 3. Supplementary requirements for electro-mechanical blood pressure measuring systems. British Standard BS EN 1060-3: 1997. European Standard EN 1060-3 1997. European Committee for Standardization. Central Secretariat: rue de Stassart 36, B-1050, Brussels.
 

Simulators

John N, Amoore JN, Lemesre Y, Murray IC, Mieke S, King ST, Smith FE, Murray A. Automatic blood pressure measurement: the oscillometric waveform shape is a potential contributor to differences between oscillometric and auscultatory pressure measurements Journal of Hypertension 2008;26:35–43
 
Amoore JN, Vacher E, Murray IC, Mieke S, King ST, Smith FE, Murray A. Can a simulator that regenerates physiological waveforms evaluate oscillometric non-invasive blood pressure devices? Blood Pressure Monitoring 2006;11:63-67
 
Davis P D, Dennis J L and Railton R. Evaluation of the A&D UA-767 and Welch Allyn Spot Vital Signs noninvasive blood pressure monitors using a blood pressure simulator. Journal of Human Hypertension 2005;3:197-203
 

Device Equivalence

Atkins N, O'Brien E. The dabl Educational Trust Device Equivalence Procedure Blood Pressure Monitoring 2007;12:245-249

 

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