What is the methodological and reporting quality of health related quality of life in chronic heart failure clinical trials?

International Journal of Cardiology

Volumn 164, Issue 2, 2013, Pages 133-140

  Chang, Sungwon ^a,b   Davidson, Patricia M ^c,d   Newton, Phillip J ^d   Krum, Henry ^e   Salamonson, Yenna ^b   MacDonald, Peter ^c,f  

^a CURTIN UNIVERSITY   (Australia)

^b UNIVERSITY OF WESTERN SYDNEY   (Australia)

^c ST VINCENT S HOSPITAL   (Australia)

^d UNIVERSITY OF TECHNOLOGY SYDNEY   (Australia)

^e MONASH UNIVERSITY   (Australia)

^f UNIVERSITY OF NEW SOUTH WALES   (Australia)

Author keywords

Chronic heart failure; Clinical decision making; Health related quality of life; Methodological quality; Randomized clinical trials

Indexed keywords

ARGININE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CANDOXATRIL; CAPTOPRIL; CARVEDILOL; CILAZAPRIL; DELAPRIL; DIGOXIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; ENALAPRIL; ENOXIMONE; HYDRALAZINE; INOTROPIC AGENT; IRBESARTAN; IRON; ISOSORBIDE DINITRATE; LEVOSIMENDAN; LOSARTAN; METOPROLOL; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PLACEBO; RAMIPRIL; URAPIDIL; VALSARTAN;

EMBASE; HEART FAILURE; HUMAN; MEDLINE; METHODOLOGY; PRIORITY JOURNAL; QUALITY CONTROL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; STANDARDIZATION; TREATMENT OUTCOME; ARTICLE; CHILD BEHAVIOR CHECKLIST; CLINICAL DECISION MAKING; CONTROLLED STUDY; DISEASE CLASSIFICATION; HEALTH CARE QUALITY; MAJOR CLINICAL STUDY; PROGNOSIS; SAMPLE SIZE;

CHRONIC DISEASE; HEALTH STATUS; HEART FAILURE; HUMANS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84875219920     PISSN: 01675273     EISSN: 18741754     Source Type: Journal    
DOI: 10.1016/j.ijcard.2012.01.019     Document Type: Review

References (55)

1. T.A. Murberg, E. Bru, S. Svebak, R. Tveteras, and T. Aarsland Depressed mood and subjective health symptoms as predictors of mortality in patients with congestive heart failure: a two-year follow-up study Int J Psychiatry Med 29 1999 311 326
2. F.D.R. Hobbs, J.E. Kenkre, A.K. Roalfe, R.C. Davis, R. Hare, and M.K. Davies Impact of heart failure and left ventricular systolic dysfunction on quality of life. A cross-sectional study comparing common chronic cardiac and medical disorders and a representative adult population Eur Heart J 23 2002 1867 1876
3. A.L. Stewart, S. Greenfield, and R.D. Hays Functional status and well-being of patients with chronic conditions: results from the medical outcomes study JAMA 262 1989 907 913
4. S. Clifford, N. Barber, R. Elliott, E. Hartley, and R. Horne Patient-centred advice is effective in improving adherence to medicines Pharm World Sci 28 2006 165 170
5. K. Morgan, H. McGee, and E. Shelley Quality of life assessment in heart failure interventions: a 10-year (1996-2005) review Eur J Cardiovasc Prev Rehabil 14 2007 589 607
6. J.A. Spertus Evolving applications for patient-centered health status measures Circulation 118 2008 2103 2110
7. J. Greenhalgh The applications of PROs in clinical practice: what are they, do they work, and why? Qual Life Res 18 2009 115 123
8. O. Chassany, P. Sagnier, P. Marquis, S. Fullerton, and N. Aaronson Patient-reported outcomes: the example of health-related quality of life - a European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process Drug Inf J 36 2002 209 238
9. F. Efficace, A. Bottomley, and D. Osoba Beyond the development of health-related quality-of-life (HRQOL) measures: a checklist for evaluating HRQOL outcomes in cancer clinical trials - does HRQOL evaluation in prostate cancer research inform clinical decision making? J Clin Oncol 21 2003 3502 3511
10. T.M. Gill, and A.R. Feinstein A critical appraisal of the quality of quality-of-life measurements JAMA 272 1994 619 626
11. A.K. Kvam, P. Fayers, M. Hjermstad, N. Gulbrandsen, and F. Wisloff Health-related quality of life assessment in randomised controlled trials in multiple myeloma: a critical review of methodology and impact on treatment recommendations Eur J Haematol 83 2009 279 289
12. C. Berry, and J. McMurray A review of quality-of-life evaluations in patients with congestive heart failure Pharmacoeconomics 16 1999 247 271
13. O. Garin, M. Ferrer, and À. Pont Disease-specific health-related quality of life questionnaires for heart failure: a systematic review with meta-analyses Qual Life Res 18 2009 71 85
14. N. Leidy, A. Rentz, and T. Zyczynski Evaluating health-related quality-of-life outcomes in patients with congestive heart failure: a review of recent randomised controlled trials Pharmacoeconomics 15 1999 19 46
15. K. Mörike, and J.R. Sindermann Drug treatment for chronic systolic heart failure Thorac Cardiovasc Surg 58 2010 S170 S172
16. S. Hunt, W. Abraham, and M. Chin ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.American College of Cardiology Web Site Available at: http://www.acc.org/clinical/guidelines/failure//index.pdf 2005
17. U.S. Department of Health and Human Services Food and Drug Administration Guidance for Industry Patient-reported outcome measures: use in medical product development to support labeling claims U.S FDA, Clinical/Medical; 2009 [cited 2010 16 Nov]; Available from: www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf
18. I. Boutron, F. Tubach, B. Giraudeau, and P. Ravaud Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis JAMA 290 2003 1062 1070
19. I. Boutron, D. Moher, and P. Tugwell A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus J Clin Epidemiol 58 2005 1233 1240
20. A.J. Cowley, B.L. Wiens, and R. Segal Randomised comparison of losartan vs. captopril on quality of life in elderly patients with symptomatic heart failure: the losartan heart failure ELITE quality of life substudy Qual Life Res 9 2000 377 384
21. O. Ekeberg, T.O. Klemsdal, and S.E. Kjeldsen Quality of life on enalapril after acute myocardial infarction Eur Heart J 15 1994 1135 1139
22. G. Majani, A. Giardini, and C. Opasich Effect of valsartan on quality of life when added to usual therapy for heart failure: results from the Valsartan Heart Failure Trial J Card Fail 11 2005 253 259
23. W.J. Rogers, D.E. Johnstone, and S. Yusuf Quality of life among 5,025 patients with left ventricular dysfunction randomized between placebo and enalapril: the studies of left ventricular dysfunction J Am Coll Cardiol 23 1994 393 400
24. E. Lader, D. Egan, S. Hunsberger, R. Garg, S. Czajkowski, and F. McSherry The effect of digoxin on the quality of life in patients with heart failure J Card Fail 9 2003 4 12
25. M.A. Konstam, J.D. Neaton, and P.A. Poole-Wilson Comparison of losartan and captopril on heart failure-related outcomes and symptoms from the losartan heart failure survival study (ELITE II) Am Heart J 150 2005 123 131
26. A. Hjalmarson, S. Goldstein, and B. Fagerberg Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: the metoprolol CR/XL randomized intervention trial in congestive heart failure (MERIT-HF). MERIT-HF Study Group JAMA 283 2000 1295 1302
27. J. Lubsen Effect of pimobendan on exercise capacity in patients with heart failure: main results from the Pimobendan in Congestive Heart Failure (PICO) trial Heart 76 1996 223 231
28. F. Efficace, D. Osoba, C. Gotay, M. Sprangers, C. Coens, and A. Bottomley Has the quality of health-related quality of life reporting in cancer clinical trials improved over time? Towards bridging the gap with clinical decision making Ann Oncol 18 2007 775 781
29. M.R. Kinney, S.N. Burfitt, E. Stullenbarger, B. Rees, and M.R. DeBolt Quality of life in cardiac patient research: a meta-analysis Nurs Res 45 1996 173 180
30. O.J. Phung, C.M. White, W.L. Baker, and C.I. Coleman Assessing the usefulness of health-related quality-of-life trials: a clinician's perspective using two COPD examples Ann Pharmacother 43 2009 1496 1505
31. C. Byrne, A. Griffin, J. Blazeby, T. Conroy, and F. Efficace Health-related quality of life as a valid outcome in the treatment of advanced colorectal cancer Eur J Surg Oncol 33 2007 S95 S104
32. J.A. Sloan, N. Aaronson, J.C. Cappelleri, D.L. Fairclough, and C. Varricchio Assessing the clinical significance of single items relative to summated scores Mayo Clin Proc 77 2002 479 487
33. J.A. Sloan, and A. Dueck Issues for statisticians in conducting analyses and translating results for quality of life end points in clinical trials J Biopharm Stat 14 2004 73 96
34. L. Hakamies-Blomqvist, M.L. Luoma, and J. Sjöström Timing of quality of life (QoL) assessments as a source of error in oncological trials J Adv Nurs 35 2001 709 716
35. D.A. Revicki, D. Osoba, and D. Fairclough Recommendations on health-related quality of life research to support labeling and promotional claims in the United States Qual Life Res 9 2000 887 900
36. D.G. Contopoulos-Ioannidis, A. Karvouni, I. Kouri, and J.P.A. Ioannidis Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review BMJ 338 2009 a3037
37. M.A.G. Sprangers, C.M. Moinpour, T.J. Moynihan, D.L. Patrick, and D.A. Revicki The Clinical Significance Consensus Meeting Group. Assessing meaningful change in quality of life over time: a users' guide for clinicans Mayo Clin Proc 77 2002 561 571
38. M. Staquet, R. Berzon, D. Osoba, and D. Machin Guidelines for reporting results of quality of life assessments in clinical trials Qual Life Res 5 1996 496 502
39. US Food and Drug Administration Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance Health Qual Life Outcomes 4 2006 79 99
40. M.A.G. Sprangers Disregarding clinical trial-based patient-reported outcomes is unwarranted: five advances to substantiate the scientific stringency of quality-of-life measurement Acta Oncol 49 2010 155 163
41. The Consolidated Standards of Reporting Trials (CONSORT) CONSORT Quality of Life Extension under development [updated August 15 2011]; Available from: http://www.consort-statement.org/consort-quality-of-life-extension-under- development/ 2011
42. S.J. Baligadoo, H. Subratty, M. Manraz, A. Tarral, D. Maiti, and M. Murday Effects of enoximone on quality of life Int J Cardiol 28 1990 S29 S32
43. T.S. Rector, G. Johnson, and W.B. Dunkman Evaluation by patients with heart failure of the effects of enalapril compared with hydralazine plus isosorbide dinitrate on quality of life. V-HeFT II. The V-HeFT VA Cooperative Studies Group Circulation 87 1993 VI71 V177
44. J.N. Cohn, M.B. Fowler, and M.R. Bristow Safety and efficacy of carvedilol in severe heart failure J Card Fail 3 1997 173 179
45. A. Dorszewski, E. Gohmann, B. Dorszewski, G.S. Werner, H. Kreuzer, and H.R. Figulla Vasodilation by urapidil in the treatment of chronic congestive heart failure in addition to angiotensin-converting enzyme inhibitors is not beneficial: results of a placebo-controlled, double-blind study J Card Fail 3 1997 91 96
46. C.J. Bulpitt, A.E. Fletcher, L. Dossegger, A. Neiss, T. Nielsen, and S. Viergutz Quality of life in chronic heart failure: cilazapril and captopril versus placebo. Cilazapril-Captopril Multicentre Group Heart 79 1998 593 598
47. D.E. Newby, T. McDonagh, P.F. Currie, D.B. Northridge, N.A. Boon, and H.J. Dargie Candoxatril improves exercise capacity in patients with chronic heart failure receiving angiotensin converting enzyme inhibition Eur Heart J 19 1998 1808 1813
48. J.E. Sanderson, S.K.W. Chan, and G. Yip Beta-blockade in heart failure: a comparison of carvedilol with metoprolol J Am Coll Cardiol 34 1999 1522 1528
49. J.W. Fung, S.K. Chan, L.Y. Yeung, and J.E. Sanderson Is beta-blockade useful in heart failure patients with atrial fibrillation? An analysis of data from two previously completed prospective trials Eur J Heart Fail 4 2002 489 494
50. A.L. Lopez-Candales, C. Carron, and J. Schwartz Need for hospice and palliative care services in patients with end-stage heart failure treated with intermittent infusion of inotropes Clin Cardiol 27 2004 23 28
51. S.D. Rajendran, Y.M. Rao, S. Thanikachalam, T.R. Muralidharan, and M. Anbalagan Comparison of target concentration intervention strategy with conventional dosing of digoxin Indian Heart J 57 2005 265 267
52. J.T. Parissis, C. Papadopoulos, and M. Nikolaou Effects of levosimendan on quality of life and emotional stress in advanced heart failure patients Cardiovasc Drugs Ther 21 2007 263 268
53. K. Kourea, J.T. Parissis, and D. Farmakis Effects of darbepoetin-alpha on quality of life and emotional stress in anemic patients with chronic heart failure Eur J Cardiovasc Prev Rehabil 15 2008 365 369
54. G.W. Yip, M. Wang, and T. Wang The Hong Kong diastolic heart failure study: a randomised controlled trial of diuretics, irbesartan and ramipril on quality of life, exercise capacity, left ventricular global and regional function in heart failure with a normal ejection fraction Heart 94 2008 573 580
55. P. Fontanive, G. Saponati, and A. Iurato Effects of l-arginine on the Minnesota Living with Heart Failure Questionnaire quality-of-life score in patients with chronic systolic heart failure Med Sci Monit 15 2009 CR606 CR611