Skip to main content

Advertisement

Log in

Patient-Reported Outcomes in Heart Failure: Existing Measures and Future Uses

  • Self-Care and Health Outcomes (T Jaarsma, Section Editor)
  • Published:
Current Heart Failure Reports Aims and scope Submit manuscript

Abstract

Patient-reported outcomes (PROs) are any report obtained directly from a patient about how they feel or function in relation to their health condition and its therapies. Strong support for PROs exists at multiple levels of the health-care community from regulatory boards to clinical researchers. PROs are particularly important in heart failure because it is a common chronic illness marked with acute exacerbations, often requiring hospitalization, and significant symptom burden. Use of PROs to understand patient perspectives will help providers deliver more patient-centered care, and thus improve the quality of care. This review provides a contemporary overview of the current state of PROs in heart failure and suggests future directions and opportunities to advance PRO use to provide more comprehensive care. Advancing PRO measurement along with incorporating longitudinal measures in national databases and local electronic health records will serve to improve patient-centered care for patients with heart failure.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. Higgins, Julian PT, ed. Cochrane handbook for systematic reviews of interventions. vol. 5. Chichester: Wiley-Blackwell, 2008.

  2. Go AS et al. Heart disease and stroke statistics—2013 update: a report from the American Heart Association. Circulation. 2013;127(1):e6–e245.

    Article  PubMed  Google Scholar 

  3. Patrick DL et al. Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health. 2007;10 Suppl 2:S125–37.

    Article  PubMed  Google Scholar 

  4. Youngblut JM, Casper GR. Focus on psychometrics single-item indicators in nursing research. Res Nurs Health. 1993;16(6):459–65.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  5. Fan X, Lee KS, Frazier SK, Lennie TA, Moser DK. Psychometric testing of the Duke Activity Status Index in patients with heart failure. Eur J Cardiovasc Nurs. 2014. doi:10.1177/1474515114523354.

  6. Hlatky MA et al. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989;64(10):651–4.

    Article  CAS  PubMed  Google Scholar 

  7. Ware Jr JE. SF-36 health survey update. Spine. 2000;25(24):3130–9.

    Article  PubMed  Google Scholar 

  8. Rector T, Kubo S, Cohn J. Patients’ self-assessment of their congestive heart failure. Part 2: content, reliability and validity of a new measure, the Minnesota Living with Heart Failure Questionnaire. Heart Fail. 1987;3(5):198–209.

    Google Scholar 

  9. Green CP et al. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000;35(5):1245–55.

    Article  CAS  PubMed  Google Scholar 

  10. Ware Jr J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–33.

    Article  PubMed  Google Scholar 

  11. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–13.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  12. Derogatis LR et al. The Hopkins Symptom Checklist (HSCL): a self-report symptom inventory. Behav Sci. 1974;19(1):1–15.

    Article  CAS  PubMed  Google Scholar 

  13. Cella DF et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993;11(3):570–9.

    CAS  PubMed  Google Scholar 

  14. Brucker PS et al. General population and cancer patient norms for the Functional Assessment of Cancer Therapy-General (FACT-G). Eval Health Prof. 2005;28(2):192–211.

    Article  PubMed  Google Scholar 

  15. Whoqol S. A cross-cultural study of spirituality, religion, and personal beliefs as components of quality of life. Soc Sci Med. 2006;62:1486–97.

    Article  Google Scholar 

  16. Bennett SJ et al. Beliefs about medication and dietary compliance in people with heart failure: an instrument development study. Heart Lung. 1997;26(4):273–9.

    Article  PubMed  Google Scholar 

  17. Bennett SJ et al. Reliability and validity of the compliance belief scales among patients with heart failure. Heart Lung. 2001;30(3):177–85.

    Article  CAS  PubMed  Google Scholar 

  18. Bentley B et al. Demonstration of psychometric soundness of the Dietary Sodium Restriction Questionnaire in patients with heart failure. Heart Lung. 2009;38(2):121–8.

    Article  PubMed  Google Scholar 

  19. Lennie TA et al. Relationship of heart failure patients’ knowledge, perceived barriers, and attitudes regarding low-sodium diet recommendations to adherence. Prog Cardiovasc Nurs. 2008;23(1):6–11.

    Article  PubMed  Google Scholar 

  20. Riegel B, Carlson B, Glaser D. Development and testing of a clinical tool measuring self-management of heart failure. Heart Lung J Acute Crit Care. 2000;29(1):4–15.

    Article  CAS  Google Scholar 

  21. Baker DW et al. A telephone survey to measure communication, education, self-management, and health status for patients with heart failure: the Improving Chronic Illness Care Evaluation (ICICE). J Card Fail. 2005;11(1):36–42.

    Article  PubMed  Google Scholar 

  22. Baker DW et al. Differences in education, knowledge, self-management activities, and health outcomes for patients with heart failure cared for under the chronic disease model: the improving chronic illness care evaluation. J Card Fail. 2005;11(6):405–13.

    Article  PubMed  Google Scholar 

  23. Jaarsma T et al. The European Heart Failure Self-care Behaviour scale revised into a nine-item scale (EHFScB-9): a reliable and valid international instrument. Eur J Heart Fail. 2009;11(1):99–105.

    Article  PubMed  Google Scholar 

  24. Brehaut JC et al. Validation of a decision regret scale. Med Decis Mak. 2003;23(4):281–92.

    Article  Google Scholar 

  25. Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004;36(8):588–94.

    PubMed  Google Scholar 

  26. Wallace LS et al. Brief report: screening items to identify patients with limited health literacy skills. J Gen Intern Med. 2006;21(8):874–7.

    Article  PubMed Central  PubMed  Google Scholar 

  27. Rumsfeld JS. Health status and clinical practice: when will they meet? Circulation. 2002;106(1):5–7.

    Article  PubMed  Google Scholar 

  28. Spertus JA et al. 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(4):636–42.

    Article  PubMed  Google Scholar 

  29. Rumsfeld JS et al. Cardiovascular health: the importance of measuring patient-reported health status: a scientific statement from the American Heart Association. Circulation. 2013;127(22):2233–49. Comprehensive review of patient-reported health status measures, with emphasis on future uses and implementation.

    Article  PubMed  Google Scholar 

  30. Calkins DR et al. Failure of physicians to recognize functional disability in ambulatory patients. Ann Intern Med. 1991;114(6):451–4.

    Article  CAS  PubMed  Google Scholar 

  31. Heidenreich PA et al. Health status identifies heart failure outpatients at risk for hospitalization or death. J Am Coll Cardiol. 2006;47(4):752–6.

    Article  PubMed  Google Scholar 

  32. Mommersteeg PMC et al. Health status as a risk factor in cardiovascular disease: a systematic review of current evidence. Am Heart J. 2009;157(2):208–18.

    Article  PubMed  Google Scholar 

  33. Chan PS et al. 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(3):398–407.

    Article  PubMed  Google Scholar 

  34. Rector TS et al. Use of the living with heart failure questionnaire to ascertain patients’ perspectives on improvement in quality of life versus risk of drug-induced death. J Card Fail. 1995;1(3):201–6.

    Article  CAS  PubMed  Google Scholar 

  35. Tsevat J et al. Health values of hospitalized patients 80 years or older. HELP Investigators. Hospitalized elderly longitudinal project. JAMA. 1998;279(5):371–5.

    Article  CAS  PubMed  Google Scholar 

  36. Lewis EF et al. Preferences for quality of life or survival expressed by patients with heart failure. J Heart Lung Transplant. 2001;20(9):1016–24.

    Article  CAS  PubMed  Google Scholar 

  37. Brunner-La Rocca HP et al. End-of-life preferences of elderly patients with chronic heart failure. Eur Heart J. 2012;33(6):752–9.

    Article  PubMed  Google Scholar 

  38. Kraai IH et al. Preferences of heart failure patients in daily clinical practice: quality of life or longevity? Eur J Heart Fail. 2013;15(10):1113–21.

    Article  PubMed  Google Scholar 

  39. Yancy CW et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128(16):e240–327.

    Article  PubMed  Google Scholar 

  40. Forum NQ NQF-Endorsed Measures for Cardiovascular Conditions: 2014. 2014 [cited 2014 December 4]; Available from: http://www.qualityforum.org/Publications/2014/11/NQF-Endorsed_Measures_for_Cardiovascular_Conditions.aspx. Most recent National Quality Forum review of endorsed measures and methods for adequate documentation.

  41. Members WC et al. ACCF/AHA/AMA-PCPI 2011 Performance measures for adults with heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures and the American Medical Association–Physician Consortium for Performance Improvement. Circulation. 2012;125(19):2382–401.

    Article  Google Scholar 

  42. Anker SD et al. The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials. Eur Heart J. 2014;35(30):2001–9.

    Article  PubMed  Google Scholar 

  43. Frank L et al. The PCORI perspective on patient-centered outcomes research. JAMA. 2014;312(15):1513–4. Explanation of PCORI goals for the future as well as a reivew of current grant selection process.

    Article  CAS  PubMed  Google Scholar 

  44. Institute P.-C.O.R. Patient Centered Outcomes Research. 2013 November 7, 2013 [cited 2014 November 2, 2014]; May 8, 2012: [Available from: http://www.pcori.org/content/patient-centered-outcomes-research.

  45. Institute of Medicine, Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, D.C.: National Academy Press; 2001.

  46. Zannad F et al. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur J Heart Fail. 2013;15(10):1082–94.

    Article  PubMed  Google Scholar 

  47. Eton DT et al. A systematic review of patient-reported measures of burden of treatment in three chronic diseases. Patient Relat Outcome Meas. 2013;4:7–20.

    Article  PubMed Central  PubMed  Google Scholar 

  48. Spertus JA. Evolving applications for patient-centered health status measures. Circulation. 2008;118(20):2103–10.

    Article  PubMed  Google Scholar 

  49. US Department of Health and Human Services, FDA. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health and Quality of Life Outcomes. 2006;4:79. doi:10.1186/1477-7525-4-79.

  50. Dyer MT et al. A review of health utilities using the EQ-5D in studies of cardiovascular disease. Health Qual Life Outcomes. 2010;8(13):1–12.

    Google Scholar 

  51. The EQ-5D: An instrument Designed to Describe and Value Health. [cited 2014 October 14]; Available from: http://www.euroqol.org/.

  52. Nowels D et al. Validation of the EQ-5D quality of life instrument in patients after myocardial infarction. Qual Life Res. 2005;14(1):95–105.

    Article  PubMed  Google Scholar 

  53. Anker SD et al. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009;361(25):2436–48.

    Article  CAS  PubMed  Google Scholar 

  54. Rector TS, Cohn JN. Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. Am Heart J. 1992;124(4):1017–25.

    Article  CAS  PubMed  Google Scholar 

  55. Guyatt GH et al. Development and testing of a new measure of health status for clinical trials in heart failure. J Gen Intern Med. 1989;4(2):101–7.

    Article  CAS  PubMed  Google Scholar 

  56. Wiklund I et al. Self-assessment of quality of life in severe heart failure: an instrument for clinical use. Scand J Psychol. 1987;28(3):220–5.

    Article  CAS  PubMed  Google Scholar 

  57. Zambroski CH et al. Impact of symptom prevalence and symptom burden on quality of life in patients with heart failure. Eur J Cardiovasc Nurs. 2005;4(3):198–206.

    Article  PubMed  Google Scholar 

  58. Hawthorne G et al. Deriving utility scores from the SF-36 health instrument using Rasch analysis. Qual Life Res. 2008;17(9):1183–93.

    Article  PubMed  Google Scholar 

  59. Cella D et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol. 2010;63(11):1179–94.

    Article  PubMed Central  PubMed  Google Scholar 

  60. Raphael C et al. Limitations of the New York Heart Association functional classification system and self-reported walking distances in chronic heart failure. Heart. 2007;93(4):476–82.

    Article  PubMed Central  PubMed  Google Scholar 

  61. Tate 3rd CW et al. Quality of life and prognosis in heart failure: results of the Beta-Blocker Evaluation of Survival Trial (BEST). J Card Fail. 2007;13(9):732–7.

    Article  PubMed  Google Scholar 

  62. Flynn KE et al. Relationships between changes in patient-reported health status and functional capacity in outpatients with heart failure. Am Heart J. 2012;163(1):88.e3–94.e3.

    Article  Google Scholar 

  63. Kosiborod M et al. Identifying heart failure patients at high risk for near-term cardiovascular events with serial health status assessments. Circulation. 2007;115(15):1975–81.

    Article  PubMed  Google Scholar 

  64. Spertus J et al. Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J. 2005;150(4):707–15.

    Article  PubMed  Google Scholar 

  65. Leibner ES et al. Changes in the functional status measures of heart failure patients with mechanical assist devices. ASAIO J. 2013;59(2):117–22. doi:10.1097/MAT.0b013e3182816cb7.

    Article  PubMed  Google Scholar 

  66. Luther SA et al. The relationship between B-type natriuretic peptide and health status in patients with heart failure. J Card Fail. 2005;11(6):414–21.

    Article  CAS  PubMed  Google Scholar 

  67. Design of the Beta-Blocker Evaluation Survival Trial (BEST). The BEST Steering Committee. American Journal of Cardiology. 1995;75(17):1220–3.

  68. Ekman I et al. Effects of person-centred care in patients with chronic heart failure: the PCC-HF study. Eur Heart J. 2012;33(9):1112–9.

    Article  PubMed Central  PubMed  Google Scholar 

  69. Schiffer AA et al. Health status in patients treated with cardiac resynchronization therapy: modulating effects of personality. Pacing Clin Electrophysiol. 2008;31(1):28–37.

    Article  PubMed  Google Scholar 

  70. Mark DB et al. Quality-of-life outcomes with coronary artery bypass graft surgery in ischemic left ventricular dysfunction: a randomized trial. Ann Intern Med. 2014;161(6):392–9.

    Article  PubMed Central  PubMed  Google Scholar 

  71. Nesbitt T et al. Correlates of quality of life in rural heart failure patients. Circ Heart Fail. 2014;7:882–7.

    Article  PubMed  Google Scholar 

  72. Edelman JJ et al. Percutaneous mitral valve repair in a high-risk Australian series. Heart Lung Circ. 2014;23(6):520–6.

    Article  CAS  PubMed  Google Scholar 

  73. Filippatos G et al. Intravenous ferric carboxymaltose in iron-deficient chronic heart failure patients with and without anaemia: a subanalysis of the FAIR-HF trial. Eur J Heart Fail. 2013;15(11):1267–76.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  74. Kerrigan DJ, Williams CT, Ehrman JK, Saval MA, Bronsteen K, Schairer JR, Swaffer M, Brawner CA, Lanfear DE, Selektor Y, Velez M, Tita C, Keteyian SJ. Cardiac rehabilitation improves functional capacity and patient-reported health status in patients with continuous-flow left ventricular assist devices: the Rehab-VAD randomized controlled trial. JACC Heart Failure. 2014;2(6):653–9.

  75. Costanzo MR et al. Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure. J Am Coll Cardiol. 2007;49(6):675–83.

    Article  CAS  PubMed  Google Scholar 

  76. St John Sutton MG et al. Effect of cardiac resynchronization therapy on left ventricular size and function in chronic heart failure. Circulation. 2003;107(15):1985–90.

    Article  PubMed  Google Scholar 

  77. Xiong GL et al. Health status and depression remission in patients with chronic heart failure: patient-reported outcomes from the SADHART-CHF trial. Circ Heart Fail. 2012;5(6):688–92.

    Article  PubMed Central  PubMed  Google Scholar 

  78. Anand IS, Florea VG, Fisher L. Surrogate end points in heart failure. J Am Coll Cardiol. 2002;39(9):1414–21.

    Article  PubMed  Google Scholar 

  79. McMurray JJV et al. Angiotensin–neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993–1004.

    Article  PubMed  Google Scholar 

  80. Reynolds MR et al. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011;124(18):1964–72.

    Article  PubMed  Google Scholar 

  81. Bekelman DB et al. Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial. BMC Cardiovasc Disord. 2013;13:49.

    Article  PubMed Central  PubMed  Google Scholar 

  82. Allen LA et al. Identifying patients hospitalized with heart failure at risk for unfavorable future quality of life. Circ Cardiovasc Qual Outcomes. 2011;4(4):389–98.

    Article  PubMed Central  PubMed  Google Scholar 

  83. Conard MW et al. Patient-reported economic burden and the health status of heart failure patients. J Card Fail. 2006;12(5):369–74.

    Article  PubMed  Google Scholar 

  84. Sandau KE et al. A conceptual definition of quality of life with a left ventricular assist device: results from a qualitative study. Heart Lung. 2014;43(1):32–40.

    Article  PubMed  Google Scholar 

  85. Modica M, Ferratini M, Torri A, Oliva F, Martinelli L, De Maria R, et al. Quality of Life and Emotional Distress Early After Left Ventricular Assist Device Implant: A Mixed-Method Study. Artificial Organs. 2014. doi:10.1111/aor.12362.

  86. McIlvennan CK et al. Decision making for destination therapy left ventricular assist devices: “there was no choice” versus “I thought about it an awful lot”. Circ Cardiovasc Qual Outcomes. 2014;7(3):374–80.

    Article  PubMed  Google Scholar 

  87. McIlvennan CK, Allen LA. To DT or not to DT, that is the question: working toward a comprehensive, patient-centered perspective on left ventricular assist device for destination therapy. Circ Cardiovasc Qual Outcomes. 2014;7(1):13–4.

    Article  PubMed  Google Scholar 

  88. Brouwers C et al. Patient-reported outcomes in left ventricular assist device therapy: a systematic review and recommendations for clinical research and practice. Circ Heart Fail. 2011;4(6):714–23.

    Article  PubMed  Google Scholar 

  89. Registry P. NCDR® PINNACLE Registry® v1.3 Full Data Dictionary. [cited 2014 December 10]; Available from: https://www.ncdr.com/WebNCDR/docs/default-source/pinnacle-public-documents/pinnacle_full_data_dictionary(complete-ts).pdf?sfvrsn=2.

  90. Registry S.A.T. TVT Registry™ v2.0 Coder’s Data Dictionary. [cited 2014 November 15]; Available from: https://www.ncdr.com/TVT/Libraries/TVT_Library/2_0_CoderDataDictionary.sflb.ashx.

  91. Fitzgerald AA, Allen LA, Masoudi FA. The evolving landscape of quality measurement for heart failure. Ann N Y Acad Sci. 2012;1254:131–9.

    Article  PubMed Central  PubMed  Google Scholar 

  92. Lubitz SA, Benjamin EJ, Ellinor PT. Atrial fibrillation in congestive heart failure. Heart Fail Clin. 2010;6(2):187–200.

    Article  PubMed Central  PubMed  Google Scholar 

  93. Macabasco-O’Connell A et al. Relationship between literacy, knowledge, self-care behaviors, and heart failure-related quality of life among patients with heart failure. J Gen Intern Med. 2011;26(9):979–86.

    Article  PubMed Central  PubMed  Google Scholar 

  94. Peterson PN et al. Health literacy and outcomes among patients with heart failure. JAMA. 2011;305(16):1695–701.

    Article  CAS  PubMed  Google Scholar 

  95. Joyce KE et al. Incorporating the patient perspective: a critical review of clinical practice guidelines for implantable cardioverter defibrillator therapy. J Interv Card Electrophysiol. 2013;36(2):185–97.

    Article  PubMed  Google Scholar 

  96. Humphrey L et al. The Caregiver Burden Questionnaire for Heart Failure (CBQ-HF): face and content validity. Health Qual Life Outcomes. 2013;11(1):84.

    Article  PubMed Central  PubMed  Google Scholar 

  97. Luttik ML et al. The objective burden in partners of heart failure patients; development and initial validation of the Dutch Objective Burden Inventory. Eur J Cardiovasc Nurs. 2008;7(1):3–9.

    Article  PubMed  Google Scholar 

  98. Vellone E et al. Validity and reliability of the caregiver contribution to self-care of heart failure index. J Cardiovasc Nurs. 2013;28(3):245–55.

    Article  PubMed  Google Scholar 

  99. Burke RE et al. Caregivers’ perceived roles in caring for patients with heart failure: what do clinicians need to know? J Card Fail. 2014;20(10):731–8.

    Article  PubMed  Google Scholar 

Download references

Compliance with Ethics Guidelines

Conflict of Interest

Lauren E. Thompson declares that she has no conflict of interest.

David B. Bekelman declares that he has no conflict of interest.

Larry A. Allen has received financial support through a grant from the Patient-Centered Outcomes Research Institute (PCORI), and has received compensation from Novartis, Otsuka, and Johnson & Johnson for service as a consultant.

Pamela N. Peterson declares that she has no conflict of interest.

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the US government.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Pamela N. Peterson.

Additional information

This article is part of the Topical Collection on Self-Care and Health Outcomes

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Thompson, L.E., Bekelman, D.B., Allen, L.A. et al. Patient-Reported Outcomes in Heart Failure: Existing Measures and Future Uses. Curr Heart Fail Rep 12, 236–246 (2015). https://doi.org/10.1007/s11897-015-0253-9

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11897-015-0253-9

Keywords

Navigation