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Chapter 1 - Statistics Used to Assess Monitors and Monitoring Applications

Published online by Cambridge University Press:  28 April 2020

By
Lester A. H. Critchley
Edited by
Andrew B. Leibowitz  and
Suzan Uysal
Andrew B. Leibowitz
Affiliation:
Icahn School of Medicine at Mount Sinai
Suzan Uysal
Affiliation:
Icahn School of Medicine at Mount Sinai
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Summary

Continuous point-of-care patient monitoring is now the standard in emergency room and critical care settings, and the technology to produce small, affordable, safe bedside vital sign monitors is ubiquitous. The statistical methods to validate these emerging monitoring technologies, however, are in their infancy. Validation statistics have centered on the Bland–Altman method and cardiac output measurement, but this method fails to evaluate the ability of a device to reliably detect serial changes (trend analysis). Newer statistical methods such as concordance and polar plots have been developed to assess trending. Small-sized studies assessing within-subject trending require other statistical approaches. Since clinical validation studies must be of a sufficient standard to be used in evidence-based reviews, researchers assessing the value of emerging clinical monitoring technologies must have an understanding of these new statistical methodologies. They must also take into consideration the precision of the reference method and issues pertaining to setting the criteria for accepting a new monitoring method, particularly when using percentage error and the traditional <30% benchmark.

Keywords

Clinical monitoringcardiac outputthermodilutionstatistical methodsvalidationBland–Altmanpercentage errorconcordancepolar plots
Type
Chapter
Information
Modern Monitoring in Anesthesiology and Perioperative Care , pp. 1 - 9
Publisher: Cambridge University Press
Print publication year: 2020

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References

Oxford Centre for Evidence-based Medicine – Levels of Evidence (March 2009). www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/ (Accessed November 2017).Google Scholar
Sun, JX, Reisner, AT, Saeed, M, Heldt, T, Mark, RG. The cardiac output from blood pressure algorithms trial. Crit Care Med 2009;37:72–80.CrossRefGoogle ScholarPubMed
Huang, L, Critchley, LA. An assessment of two Doppler-based monitors to track cardiac output changes in anaesthetised patients undergoing major surgery. Anaesth Intens Care 2014;42:631–9.Google Scholar
Chong, SW, Peyton, PJ. A meta-analysis of the accuracy and precision of the ultrasonic cardiac output monitor (USCOM). Anaesthesia 2012;67:1266–71.Google Scholar
Wang, DJ, Gottlieb, SS. Impedance cardiography: more questions than answers. Curr Cardiol Rep 2006;8:180–6.Google Scholar
Koo, KK, Sun, JC, Zhou, Q, et al. Pulmonary artery catheters: evolving rates and reasons for use. Crit Care Med 2011;39:1613–8.CrossRefGoogle ScholarPubMed
Harvey, S, Harrison, DA, Singer, M, et al. Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomized controlled trial. Lancet 2005;366:472–7.Google Scholar
Reuter, DA, Huang, C, Edrich, T, Shernan, SK, Eltzschig, HK. Cardiac output monitoring using indicator dilution techniques: basics, limits, and perspectives. Anesth Analg 2010;110:799–811.CrossRefGoogle Scholar
Yang, XX, Critchley, LA, Rowlands, DK, Fang, Z, Huang, L. Systematic error of cardiac output measured by bolus thermodilution with a pulmonary artery catheter compared with that measured by an aortic flow probe in a pig model. J Cardiothorac Vasc Anesth 2013;27:1133–9.Google Scholar
Critchley, LA, Critchley, JA. A meta-analysis of studies using bias and precision statistics to compare cardiac output measurement techniques. J Clin Monit Comput 1999;15:85–91.Google Scholar
Critchley, LA. Bias and precision statistics: should we still adhere to the 30% benchmark for cardiac output monitor validation studies? Anesthesiology 2011;114:1245.Google Scholar
Biancofiore, G, Critchley, LA, Lee, A, et al. Evaluation of an uncalibrated arterial pulse contour cardiac output monitoring system in cirrhotic patients undergoing liver surgery. Brit J Anaesth 2009;102:47–54.Google Scholar
Fuller, HD. The validity of cardiac output measurement by thoracic impedance: a meta-analysis. Clin Invest Med 1992;15:103–12.Google Scholar
Bland, JM, Altman, DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307–10.Google Scholar
LaMantia, KR, O’Connor, T, Barash, PG. Comparing methods of measurement: an alternative approach. Anesthesiology 1990;72:781–3.Google Scholar
Wong, DH, Tremper, KK, Stemmer, EA, et al. Noninvasive cardiac output: simultaneous comparison of two different methods with thermodilution. Anesthesiology 1990;72:784–92.Google Scholar
Michard, F. Thinking outside the (cardiac output) box. Crit Care Med 2012;40:1361–2.CrossRefGoogle ScholarPubMed
Peyton, PJ, Chong, SW. Minimally invasive measurement of cardiac output during surgery and critical care: a metaanalysis of accuracy and precision. Anesthesiology 2010;113:1220–35.Google Scholar
Critchley, LA. Validation of the MostCare pulse contour cardiac output monitor: beyond the Bland and Altman plot. Anesth Analg 2011;113:1292–4.Google Scholar
Critchley, LA. Meta-analyses of Bland-Altman-style cardiac output validation studies: good, but do they provide answers to all our questions? Brit J Anaesth 2017;118:296–7.Google Scholar
Critchley, LA, Lee, A, Ho, AM. A critical review of the ability of continuous cardiac output monitors to measure trends in cardiac output. Anesth Analg 2010;111:1180–92.Google Scholar
Perrino, AC, O’Connor, T, Luther, M. Transtracheal Doppler cardiac output monitoring: comparison to thermodilution during noncardiac surgery. Anesth Analg 1994;78:1060–6.CrossRefGoogle ScholarPubMed
Critchley, LA, Yang, XX, Lee, A. Assessment of trending ability of cardiac output monitors by polar plot methodology. J Cardiothorac Vasc Anesth 2011;25:536–46.CrossRefGoogle ScholarPubMed
Bland, JM, Altman, DG. Agreement between methods of measurement with multiple observations per individual. J Biopharm Stat 2007;17:571–82.Google Scholar
Myles, PS, Cui, J. Using the Bland-Altman method to measure agreement with repeated measures. Br J Anaesth 2007;99:309–11.Google Scholar
Cecconi, M, Rhodes, A, Poloniecki, J, Della Rocca, G, Grounds, RM. Bench-to-bedside review: the importance of the precision of the reference technique in method comparison studies – with specific reference to the measurement of cardiac output. Crit Care 2009;13:201.CrossRefGoogle Scholar
Axiak-Flammer, SM, Critchley, LA, Weber, A, et al. Reliability of lithium dilution cardiac output in anaesthetized sheep. Brit J Anaesth 2013;111:833–9.Google Scholar
Huang, L, Critchley, LA, Zhang, J. Major upper abdominal surgery alters the calibration of BioReactance cardiac output readings, the NICOM, when comparisons are made against suprasternal and esophageal Doppler intraoperatively. Anesth Analg 2015;121:936–45.CrossRefGoogle ScholarPubMed
Mantha, S, Roizen, MF, Fleisher, LA, Thisted, R, Foss, J. Comparing methods of clinical measurement: reporting standards for Bland and Altman analysis. Anesth Analg 2000;90:593–602.Google Scholar
Dewitte, K, Fierens, C, Stöckl, D, Thienpont, LM. Application of the Bland-Altman plot for interpretation of method comparison studies: a critical investigation of its practice. Clin Chem 2002;48:799–801.Google Scholar
Berthelsen, PG, Nilsson, LB. Researcher bias and generalization of results in bias and limits of agreement analyses: a commentary based on the review of 50 Acta Anaesthesiologica Scandinavica papers using the Altman Bland approach. Acta Anaesthesiol Scand 2006;50:1111–3.Google Scholar
Bein, B, Renner, J, Scholz, J, Tonner, PH. Comparing different methods of cardiac output determination: a call for consensus. Eur J Anaesthesiol 2006;23:710.CrossRefGoogle Scholar
Abu-Arafeh, A, Jordan, H, Drummond, G. Reporting of method comparison studies: a review of advice, an assessment of current practice, and specific suggestions for future reports. Br J Anaesth 2016;117:569–75.Google Scholar
Drummond, GB. Limits of agreement with confidence intervals are necessary to assess comparability of measurement devices. Anesth Analg 2017;125:1075.Google Scholar

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