Am Heart J. 2009 Oct;158(4 Suppl):S64-71.

Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure.

Flynn KE, Lin L, Ellis SJ, Russell SD, Spertus JA, Whellan DJ, Piña IL, Fine LJ, Schulman KA, Weinfurt KP; HF-ACTION Investigators.

Collaborators (304)

O'Connor CM, Lee KL, Ellis SJ, Rendall DS, Whellan DJ, Piña IL, Keteyian SJ, Cooper LS, Boineau R, Fine LJ, Fleg JL, Leifer ES, Erickson V, Howlett JG, Miller NH, Isaac D, McKelvie R, Zannad F, Boozer S, Connolly P, Doll A, Ellis SJ, Frazier C, Mark D, McClanahan-Crowder M, Meyer M, Mickley BS, Rendall DS, Rich M, Rostami H, Settles S, Spinella K, Staib J, Thompson O, Abraham W, Biniakiewicz D, Homan J, Bittner V, Fitz-Gerald M, Ewald G, Craddock H, Flanagan J, Fonarow G, Erickson V, Colucci W, Lim NZ, Tokareva E, Alharethi R, Hershberger R, Nauman D, Keteyian SJ, Saval M, Kitzman DW, Fray BL, Moore B, Piña IL, Vest M, Smith A, Snell G, Wolfel E, Cantu M, Adams K, Glotzer J, Johnson V, Schumacher K, Blackburn G, Geither C, Moore S, Chandler AB Jr, Vaughn SB, Easler PJ, Williams D, Colmer M, Gardin JM, Dimick K, Sklar SK, Teller S, Ghali JK, Hale-Stenson K, Gheorghiade M, Strzelczyk T, Johnson MR, Vander Ark C, Goldberg LR, Kao A, Dekerlegand J, Kraus WE, Johnson J, Duscha BD, Mehra MR, Ventura H, Harris B, Colvin-Adams M, Duderstadt K, Meyer K, Steger M, Cabuay B, Oren R, Scovel P, Kao A, Stevens T, Haffey K, Mandacina C, Stewart A, Swank AM, Manire J, Thompson PD, Cosio-Lima L, Lagasse M, Naz T, Wagoner L, Roll SK, Yanowitz FG, Walker J, Mueller A, McCullough P, Coleman C, Dorrell KA, Washington T, Handberg E, Hill JA, Bakos J, Boyette A, Smith P, Williams C, Badenhop D, Schroeder S, Walter K, Kokkinos P, Collins E, Korsak L, Eichhorn E, Leonard A, Worley T, Fletcher G, Peasley P, Oldano P, Kostis J, Cosgrove NM, Thadani U, Rogan L, Thresher M, Turner J, Barnard D, Herman D, Contasti A, Sagerian M, Ofili E, Onwuanyi A, Nkemdiche S, Eisen H, Fitzpatrick J, Wald J, Wong J, Ellestad M, Kern L, Amsterdam EA, Burns MJ, Fedson S, Garg RK, Bennett P, Bond L, Chen L, Schrack J, Pearce D, Bond L, Palevo G, Serfass M, Forman D, Lopez MM, Talabi-Oates Y, Williams A, Truitte D, Baumann C, Adams J, Lawrence A, McNamara D, Gruendler E, Schneider V, Hutchins S, Hartwick A, Campbell P, Esposito M, Buchter C, Letterer RA, Taylor R, Wells C, Johnson B, Kaping B, Leathes S, O'Bryan J, Langley L, Hastings ET, Clancy C, Agruss N, Lawless C, Fortman R, McConnell TR, Wantz D, Walsh MN, Margiotti R, Russell S, Heck E, Lachmann J, Lippman D, McLaughlin J, Landzberg J, Mathus S, Cullinane DW, Voyles W, Lenz D, Kaczkowski S, David JL, Gillespie E, Keane-Richmond P, Krueger SK, Heiss L, Gottlieb S, Greenberg N, Gordon N, Parks E, Willoughby M, Kronenberg MW, Glenn J, Madison C, Arnold M, Smith JK, Azevedo E, Drobot G, Estrella-Holder E, Howlett J, Cooley-Warnell D, Yarn S, Isaac D, Grant J, Lyzun K, LeBlanc MH, Vienneau R, McKelvie RS, Beare L, Hancock J, Moe G, Golob D, Melvin K, Cymet A, Renton J, Nigam A, LaLonge J, Djaballah K, Aebehard P, Iliou MC, Sabatier R, Belin A, Cohen-Solal A, Hittinger L, Pitt B, Ades PA, Basta LL, Froelicher V, Hamel ME, Massie BM, Moyé L, Powell LH, Kraus WE, Johnson J, Piner L, Bensimhon D, Russell S, Gardin JM, Bess RL, Cohen GI, Keteyian SJ, Ehrman JK, Brawner CA, Miller NH, Blumenthal JA, Barbour K, Spruill TM, Marcus B, Raczynski J, Adams K, Donahue M, Felker M, Schulman KA, Weinfurt KP, Flynn KE, Reed S, Burnette A, Davidson-Ray L, Friedman JY, Li Y, Lin L, O'Neal B, Zile M, Johnson RH, Bensimhon DR, Bittner V, Boineau R, Dunlap ME, Kraus WE, O'Connor CM, Moe G, Wertheimer J, Whellan DJ.

Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27715, USA. kathryn.flynn@duke.edu

BACKGROUND: Patient-reported outcomes are increasingly used to assess the efficacy of new treatments. Understanding relationships between these and clinical measures can facilitate their interpretation. We examined associations between patient-reported measures of health-related quality of life and clinical indicators of disease severity in a large, heterogeneous sample of patients with heart failure. METHODS: Patient-reported measures, including the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQol Visual Analog Scale (VAS), and clinical measures, including peak VO(2), 6-minute walk distance, and New York Heart Association (NYHA) class, were assessed at baseline in 2331 patients with heart failure. We used general linear models to regress patient-reported measures on each clinical measure. Final models included for significant sociodemographic variables and 2-way interactions. RESULTS: The KCCQ was correlated with peak VO(2) (r = .21) and 6-minute walk distance (r = .27). The VAS was correlated with peak VO(2) (r = .09) and 6-minute walk distance (r = .11). Using the KCCQ as the response variable, a 1-SD difference in peak Vo(2) (4.7 mL/kg/min) was associated with a 2.86-point difference in the VAS (95% CI, 1.98-3.74) and a 4.75-point difference in the KCCQ (95% CI, 3.78-5.72). A 1-SD difference in 6-minute walk distance (105 m) was associated with a 2.78-point difference in the VAS (95% CI, 1.92-3.64) and a 5.92-point difference in the KCCQ (95% CI, 4.98-6.87); NYHA class III was associated with an 8.26-point lower VAS (95% CI, 6.59-9.93) and a 12.73-point lower KCCQ (95% CI, 10.92-14.53) than NYHA class II. CONCLUSIONS: These data may inform deliberations about how to best measure benefits of heart failure interventions, and they generally support the practice of considering a 5-point difference on the KCCQ and a 3-point difference on the VAS to be clinically meaningful.