Development and Validation of a Short Version of the Kansas City Cardiomyopathy Questionnaire

John A Spertus, Philip G Jones, John A Spertus, Philip G Jones

Abstract

Background: There is a growing demand to collect patients' experiences of their health status (their symptoms, function, and quality of life) in clinical trials, quality assessment initiatives, and in routine clinical care. In heart failure, the 23-item, disease-specific Kansas City Cardiomyopathy Questionnaire (KCCQ) has been shown to be valid, reliable, sensitive to clinical change, and prognostic of both clinical events and costs. However, its use has been limited, in part, by its length. We sought to develop a shortened version of the instrument that maintains the psychometric properties of the full KCCQ.

Methods and results: Using data from 3 clinical studies incorporating 4168 patients, we derived and validated a 12-item KCCQ, the KCCQ-12, to capture symptom frequency, physical and social limitations, and quality of life impairment as a result of heart failure, as well as an overall summary score. The KCCQ-12 scores had high correlations with the original scales (>0.93 for all scales in all clinical settings), high test–retest reliability (>0.76 for all domains), high responsiveness (16–31 point improvements after discharge from hospitalization; standardized response mean =0.61–1.12), and comparable prognostic significance and interpretation of clinically important differences as compared with the full KCCQ.

Conclusions: The KCCQ-12 is a shorter version of the original 23-item instrument that should be more feasible to implement while preserving the psychometric properties of the full instrument.

Figures

Figure.
Figure.
Data sources and study samples. EPHESUS indicates Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival; EVEREST, Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan; and KCCQ, Kansas City Cardiomyopathy Questionnaire.

References

    1. Spertus JA. Evolving applications for patient-centered health status measures. Circulation. 2008;118:2103–2110. doi: 10.1161/CIRCULATIONAHA.107.747568.
    1. Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000;35:1245–1255.
    1. Guyatt GH, Nogradi S, Halcrow S, Singer J, Sullivan MJ, Fallen EL. Development and testing of a new measure of health status for clinical trials in heart failure. J Gen Intern Med. 1989;4:101–107.
    1. Rector TS, Kubo SH, Cohn JN. Validity of the Minnesota Living with Heart Failure questionnaire as a measure of therapeutic response to enalapril or placebo. Am J Cardiol. 1993;71:1106–1107.
    1. Garin O, Herdman M, Vilagut G, Ferrer M, Ribera A, Rajmil L, Valderas JM, Guillemin F, Revicki D, Alonso J. Assessing health-related quality of life in patients with heart failure: a systematic, standardized comparison of available measures. Heart Fail Rev. 2014;19:359–367. doi: 10.1007/s10741-013-9394-7.
    1. Mackintsosh A, Gibbons E, Fitzpatrick R. A structured review of patient-reported outcome measures for people with heart failure: an update 2009. . Accessed July 13, 2015.
    1. Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med. 1993;118:622–629.
    1. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2006. pp. 1–32.
    1. Chan PS, Soto G, Jones PG, Nallamothu BK, Zhang Z, Weintraub WS, Spertus JA. Patient health status and costs in heart failure: insights from the eplerenone post-acute myocardial infarction heart failure efficacy and survival study (EPHESUS). Circulation. 2009;119:398–407. doi: 10.1161/CIRCULATIONAHA.108.820472.
    1. Heidenreich PA, Spertus JA, Jones PG, Weintraub WS, Rumsfeld JS, Rathore SS, Peterson ED, Masoudi FA, Krumholz HM, Havranek EP, Conard MW, Williams RE Cardiovascular Outcomes Research Consortium. Health status identifies heart failure outpatients at risk for hospitalization or death. J Am Coll Cardiol. 2006;47:752–756. doi: 10.1016/j.jacc.2005.11.021.
    1. Kosiborod M, Soto GE, Jones PG, Krumholz HM, Weintraub WS, Deedwania P, Spertus JA. Identifying heart failure patients at high risk for near-term cardiovascular events with serial health status assessments. Circulation. 2007;115:1975–1981. doi: 10.1161/CIRCULATIONAHA.106.670901.
    1. Soto GE, Jones P, Weintraub WS, Krumholz HM, Spertus JA. Prognostic value of health status in patients with heart failure after acute myocardial infarction. Circulation. 2004;110:546–551. doi: 10.1161/01.CIR.0000136991.85540.A9.
    1. Spertus J, Peterson E, Conard MW, Heidenreich PA, Krumholz HM, Jones P, McCullough PA, Pina I, Tooley J, Weintraub WS, Rumsfeld JS Cardiovascular Outcomes Research Consortium. Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J. 2005;150:707–715. doi: 10.1016/j.ahj.2004.12.010.
    1. Rumsfeld JS. Health status and clinical practice: when will they meet? Circulation. 2002;106:5–7.
    1. Spertus J. Barriers to the use of patient-reported outcomes in clinical care. Circ Cardiovasc Qual Outcomes. 2014;7:2–4. doi: 10.1161/CIRCOUTCOMES.113.000829.
    1. Schou M, Gustafsson F, Videbaek L, Andersen H, Toft J, Nyvad O, Ryde H, Fog L, Jensen JC, Nielsen OW, Lind-Rasmussen S, Abdulla J, Hildebrandt PR NorthStar Investigators. Adding serial N-terminal pro brain natriuretic peptide measurements to optimal clinical management in outpatients with systolic heart failure: a multicentre randomized clinical trial (NorthStar monitoring study). Eur J Heart Fail. 2013;15:818–827. doi: 10.1093/eurjhf/hft037.
    1. Januzzi JL, Jr, Rehman SU, Mohammed AA, Bhardwaj A, Barajas L, Barajas J, Kim HN, Baggish AL, Weiner RB, Chen-Tournoux A, Marshall JE, Moore SA, Carlson WD, Lewis GD, Shin J, Sullivan D, Parks K, Wang TJ, Gregory SA, Uthamalingam S, Semigran MJ. Use of amino-terminal pro-B-type natriuretic peptide to guide outpatient therapy of patients with chronic left ventricular systolic dysfunction. J Am Coll Cardiol. 2011;58:1881–1889. doi: 10.1016/j.jacc.2011.03.072.
    1. Abraham WT. Disease management: remote monitoring in heart failure patients with implantable defibrillators, resynchronization devices, and haemodynamic monitors. Europace. 2013;15(Suppl 1):i40–i46. doi: 10.1093/europace/eut105.
    1. Loh JP, Barbash IM, Waksman R. Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System. J Am Coll Cardiol. 2013;61:1571–1576. doi: 10.1016/j.jacc.2012.08.1035.
    1. Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011;377:658–666. doi: 10.1016/S0140-6736(11)60101-3.
    1. Arnold SV, Spertus JA, Lei Y, Allen KB, Chhatriwalla AK, Leon MB, Smith CR, Reynolds MR, Webb JG, Svensson LG, Cohen DJ. Use of the Kansas City Cardiomyopathy Questionnaire for monitoring health status in patients with aortic stenosis. Circ Heart Fail. 2013;6:61–67. doi: 10.1161/CIRCHEARTFAILURE.112.970053.
    1. Joseph SM, Novak E, Arnold SV, Jones PG, Khattak H, Platts AE, Dávila-Román VG, Mann DL, Spertus JA. Comparable performance of the Kansas City Cardiomyopathy Questionnaire in patients with heart failure with preserved and reduced ejection fraction. Circ Heart Fail. 2013;6:1139–1146. doi: 10.1161/CIRCHEARTFAILURE.113.000359.
    1. Konstam MA, Gheorghiade M, Burnett JC, Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators. Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST Outcome Trial. JAMA. 2007;297:1319–1331. doi: 10.1001/jama.297.12.1319.
    1. Spertus JA, Tooley J, Jones P, Poston C, Mahoney E, Deedwania P, Hurley S, Pitt B, Weintraub WS. Expanding the outcomes in clinical trials of heart failure: the quality of life and economic components of EPHESUS (EPlerenone’s neuroHormonal Efficacy and SUrvival Study). Am Heart J. 2002;143:636–642.
    1. Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989;45:255–268.
    1. DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988;44:837–845.
    1. McDowell I. Measuring Health: A Guide to Rating Scales and Questionnaires. New York: Oxford University Press; 2006.
    1. Guyatt G, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis. 1987;40:171–178.
    1. Guyatt GH, Deyo RA, Charlson M, Levine MN, Mitchell A. Responsiveness and validity in health status measurement: a clarification. J Clin Epidemiol. 1989;42:403–408.
    1. Guyatt G, Schunemann H. How can quality of life researchers make their work more useful to health workers and their patients? Qual Life Res. 2007;16:1097–1105. doi: 10.1007/s11136-007-9223-3.
    1. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407–415.
    1. Youden WJ. Index for rating diagnostic tests. Cancer. 1950;3:32–35.
    1. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the Twenty-first Century. Washington: National Academy Press; 2001.
    1. Physician Consortium for Performance Improvement. Clinical Performance Measures in Heart Failure. A Consensus Document from the ACC, AHA and the Consortium. 2006.
    1. Bennett JA, Riegel B, Bittner V, Nichols J. Validity and reliability of the NYHA classes for measuring research outcomes in patients with cardiac disease. Heart Lung. 2002;31:262–270.
    1. Goldman L, Cook EF, Mitchell N, Flatley M, Sherman H, Cohn PF. Pitfalls in the serial assessment of cardiac functional status. How a reduction in “ordinary” activity may reduce the apparent degree of cardiac compromise and give a misleading impression of improvement. J Chronic Dis. 1982;35:763–771.
    1. Raphael C, Briscoe C, Davies J, Ian Whinnett Z, Manisty C, Sutton R, Mayet J, Francis DP. Limitations of the New York Heart Association functional classification system and self-reported walking distances in chronic heart failure. Heart. 2007;93:476–482. doi: 10.1136/hrt.2006.089656.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться