Biological quality control for cardiopulmonary exercise testing in multicenter clinical trials

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• 作者：Janos Porszasz ; Susan Blonshine ; Robert Cao ; Heather A. Paden…
• 关键词：Calibration ; Treadmill test ; Pulmonary gas exchange ; Z ; score ; Precision and accuracy
• 刊名：BMC Pulmonary Medicine
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：16
• 期：1
• 全文大小：1,195 KB
• 参考文献：1.Wasserman K, Hansen JE, Sue DY, Stringer WW, Whipp BJ. Clinical applications of cardiopulmonary exercise testing. In: Principles of Exercise Testing and Interpretation Including Pathophysiology and Clinical Applications. 4th ed. Philadelphia: Lippincott Williams & Wilkins; 2005. p. 198–241.
  2.Mezzani A, Corrà U, Giordano A, Colombo S, Psaroudaki M, Giannuzzi P. Upper intensity limit for prolonged aerobic exercise in chronic heart failure. Med Sci Sports Exerc. 2010;42(4):633–9.PubMed CrossRef
  3.Myers J, Arena R, Franklin B, Pina I, Kraus WE, McInnis K, et al. Recommendations for clinical exercise laboratories: a scientific statement from the American Heart Association. Circulation. 2009;119(24):3144–61.PubMed CrossRef
  4.American Thoracic Society (ATS)/American College of Chest Physicians (ACCP). ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003;167(2):211–77.CrossRef
  5.Casaburi R, Porszasz J, Burns MR, Carithers ER, Chang RS, Cooper CB. Physiologic benefits of exercise training in rehabilitation of patients with severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997;155(5):1541–51.PubMed CrossRef
  6.Emtner M, Porszasz J, Burns M, Somfay A, Casaburi R. Benefits of supplemental oxygen in exercise training in nonhypoxemic chronic obstructive pulmonary disease patients. Am J Respir Crit Care Med. 2003;168(9):1034–42.PubMed CrossRef
  7.Palange P, Ward SA, Carlsen KH, Casaburi R, Gallagher CG, Gosselink R, et al. Recommendations on the use of exercise testing in clinical practice. Eur Respir J. 2007;29(1):185–209.PubMed CrossRef
  8.Vogiatzis I. Strategies of muscle training in very severe COPD patients. Eur Respir J. 2011;38(4):971–5.PubMed CrossRef
  9.Maltais F, Celli B, Casaburi R, Porszasz J, Jarreta D, Seoane B, et al. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med. 2011;105(4):580–7.PubMed CrossRef
  10.Neder JA, Fuld JP, Overend T, Thirlwell J, Carter R, Stevenson R, et al. Effects of formoterol on exercise tolerance in severely disabled patients with COPD. Respir Med. 2007;101(10):2056–64.PubMed CrossRef
  11.O’Donnell DE, Flüge T, Gerken F, Hamilton A, Webb K, Aguilaniu B, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J. 2004;23(6):832–40.PubMed CrossRef
  12.Porszasz J, Stringer W, Casaburi R. Equipment, measurements and quality control in clinical exercise testing. In: Ward S, Palange P, editors. European Respiratory Monograph, No 40. Volume 12. Sheffield, UK: European Respiratory Society; 2007. p. 108–28.
  13.Lamarra N, Whipp B. Measurement of pulmonary gas exchange. In: Maud PJ, Foster C, editors. Physiological Assessment of Human Fitness. Champaign: Human Kinetics; 1995. p. 19–35.
  14.Revill SM, Morgan MD. Biological quality control for exercise testing. Thorax. 2000;55(1):63–6.PubMed PubMedCentral CrossRef
  15.Arena R, Peberdy MA. Short-term reliability of oxygen uptake on-kinetics in apparently healthy subjects. J Cardiopulm Rehabil. 2006;26(4):219–23.PubMed CrossRef
  16.Hansen JE, Sun XG, Yasunobu Y, Garafano RP, Gates G, Barst RJ, et al. Reproducibility of cardiopulmonary exercise measurements in patients with pulmonary arterial hypertension. Chest. 2004;126(3):816–24.PubMed CrossRef
  17.Johnston KN, Jenkins SC, Stick SM. Repeatability of peak oxygen uptake in children who are healthy. Pediatr Phys Ther. 2005;17(1):11–7.PubMed CrossRef
  18.Porszasz J, Woodhouse LI, Casaburi R, Nguyen AHC, Tsurugaya H, Whipp BJ. Use of physiological calibration to validate gas exchange measurements during exercise. Med Sci Sports Exerc. 2004;36(5):S27.
  19.Jones NL, Kane JW. Quality control of exercise test measurements. Med Sci Sports. 1979;11(4):368–72.PubMed
  20.Gagnon J, Province MA, Bouchard C, Leon AS, Skinner JS, Wilmore JH, et al. The HERITAGE Family Study: quality assurance and quality control. Ann Epidemiol. 1996;6(6):520–9.PubMed CrossRef
  21.Brawner CA, Ehrman JK, Aldred H, Schairer JR, Keteyian SJ. Quality assurance and cardiopulmonary exercise testing in clinical trials. J Card Fail. 2008;14(4):283–9.PubMed CrossRef
  22.O’Donnell DE, Maltais F, Porszasz J, Webb KA, Albers FC, Deng Q, et al. The continuum of physiological impairment during treadmill walking in patients with mild-to-moderate COPD: patient characterization phase of a randomized clinical trial. PloS one. 2014;9(5):e96574.PubMed PubMedCentral CrossRef
  23.Casaburi R, Maltais F, Porszasz J, Albers F, Deng Q, Iqbal A, et al. Effects of tiotropium on hyperinflation and treadmill exercise tolerance in mild to moderate chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014;11(9):1351–61.PubMed CrossRef
  24.Blonshine B, Cao R, Casaburi R, Paden H, Porszasz J. Results from a multi-center cardiopulmonary exercise physiological quality control protocol. American Thoracic Society 2012 International Conference, May 18-23, 2012, San Francisco, CA, USA. Am J Resp Crit Care Med, Vol. 185, Meeting Abstracts, 2012. A43 COPD: Functional Assessment and Exercise. p. A1545.
  25.Porszasz J, Casaburi R, Somfay A, Woodhouse LJ, Whipp BJ. A treadmill ramp protocol using simultaneous changes in speed and grade. Med Sci Sports Exerc. 2003;35(9):1596–603.PubMed CrossRef
  26.Wasserman K, Hansen J, Sue D, Stringer W, Whipp B. Oxygen cost of work. In: Principles of Exercise Testing and Interpretation Including Pathophysiology and Clinical Applications. 4th ed. Philadelphia: Lippincott Williams and Wilkins; 2005. p. 19.
  27.Wasserman K, Whipp BJ. Exercise physiology in health and disease. Am Rev Respir Dis. 1975;112(2):219–49.PubMed
  28.Hansen JE, Sue DY, Wasserman K. Predicted values for clinical exercise testing. Am Rev Respir Dis. 1984;129(2 Pt 2):S49–55.PubMed CrossRef
  29.Wasserman K, Sue D. Coupling of external to cellular respiration. In: Wasserman K, editor. Exercise Gas Exchange in Heart Disease. New York: Futura Publishing; 1996.
  30.Hansen JE, Casaburi R, Cooper DM, Wasserman K. Oxygen uptake as related to work rate increment during cycle ergometer exercise. Eur J Appl Physiol Occup Physiol. 1988;57(2):140–5.PubMed CrossRef
  31.Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, et al. ACC/AHA 2002 guideline update for exercise testing: summary article. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). J Am Coll Cardiol. 2002;40(8):1531–40.PubMed CrossRef
  32.American College of Sports Medicine. ACSM’s Guidelines for Exercise Testing and Prescription. 7th ed. Philadelphia: Lippincott Williams & Wilkins; 2006.
  33.Jones NL. Clinical Exercise Testing. 3rd ed. Philadelphia: W.B Saunders; 1988.
  34.Widrick JJ, Freedson PS, Hamill J. Effect of internal work on the calculation of optimal pedaling rates. Med Sci Sports Exerc. 1992;24(3):376–82.PubMed CrossRef
  35.Zoladz JA, Rademaker AC, Sargeant AJ. Human muscle power generating capability during cycling at different pedalling rates. Exp Physiol. 2000;85(1):117–24.PubMed CrossRef
  
• 作者单位：Janos Porszasz (1)
  Susan Blonshine (2)
  Robert Cao (1)
  Heather A. Paden (3)
  Richard Casaburi (1)
  Harry B. Rossiter (1) (4)
  
  1. Rehabilitation Clinical Trials Center, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, 1124W Carson Street, Building CDCRC, Torrance, CA, 90502, USA
  2. TechEd Consultants, Inc., Mason, MI, USA
  3. Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA
  4. Faculty of Biological Sciences, University of Leeds, Leeds, UK
  
• 刊物主题：Pneumology/Respiratory System; Internal Medicine;
• 出版者：BioMed Central
• ISSN：1471-2466

文摘

Background Precision and accuracy assurance in cardiopulmonary exercise testing (CPET) facilitates multicenter clinical trials by maximizing statistical power and minimizing participant risk. Current guidelines recommend quality control that is largely based on precision at individual testing centers (minimizing test–retest variability). The aim of this study was to establish a multicenter biological quality control (BioQC) method that considers both precision and accuracy in CPET.