Quality of life as an endpoint for atrial fibrillation research: Pitfalls and practice

Heart Rhythm

Volumn 1, Issue 2 SUPPL., 2004, Pages 20-26

  Newman, David ^a  

^a ST MICHAEL'S HOSPITAL   (Canada)

Author keywords

Atrial fibrillation therapy; Endpoints in trials; Quality of life

Indexed keywords

AMIODARONE; PLACEBO; PROPAFENONE; SOTALOL;

ACCURACY; ANGIOPLASTY; ARTICLE; CATHETER ABLATION; CLINICAL TRIAL; COHORT ANALYSIS; CORONARY ARTERY DISEASE; CORRELATION FUNCTION; COST EFFECTIVENESS ANALYSIS; DATA ANALYSIS; DEFIBRILLATOR; DISEASE DURATION; FREQUENCY ANALYSIS; HEART ATRIUM FIBRILLATION; HEART ATRIUM PACING; HUMAN; HYPOTHESIS; MEDICAL DOCUMENTATION; MEDICAL INSTRUMENTATION; MEDICAL RESEARCH; OUTCOMES RESEARCH; PATIENT SELECTION; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; SENSITIVITY ANALYSIS; STANDARDIZATION; VALIDATION PROCESS;

EID: 3042818130     PISSN: 15475271     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.hrthm.2004.04.025     Document Type: Article

References (39)

1. Dorian P. Jung W. Paquette M. Newman D. Wood K. Ayers G.M. Camm J. Akhtar M. Luderitz B. The impairment of health-related quality of life in patients with intermittent atrial fibrillation: implications for the assessment of investigational therapy J Am Coll Cardiol 36 2000 1303-1309
2. Devins G. Illness intrusiveness and the psychosocial impact of lifestyle disruptions in chronic life-threatening disease Adv Renal Replace Ther 1 1994 251-263
3. Ware J.E. Jr SF-36 health survey: manual and interpretation guide 1993 The Health Institute, New England Medical CenterBoston
4. Allison T.G. Williams D.E. Miller T.D. Patten C.A. Bailey K.R. Squires R.W. Gau G.T. Medical and economic costs of psychologic distress in patients with coronary artery disease Mayo Clin Proc 70 1995 734-742
5. Guyatt G.H. Jaeschke R. Feeny D.H. et al. Measurements in clinical trials: choosing the right approach In: Spilker B. editor. Quality of life and pharmacoeconomics in clinical trials 1996 41-48 Lippincott-Raven PublishersPhiladelphia
6. Frasure-Smith N. Lesperance F. Talajic M. Depression and 18-month prognosis after myocardial infarction Circulation 91 1995 999-1005
7. Linden W. Stossel C. Maurice J. Psychosocial interventions for patients with coronary artery disease: a meta-analysis Arch Intern Med 156 1996 745-752
8. Weinstein M.C. Siegel J.E. Gold M.R. Kamlet M.S. Russell L.B. Recommendations of the Panel on Cost-effectiveness in Health and Medicine JAMA 276 1996 1253-1258
9. Feeny D. Furlong W. Torrance G.W. Goldsmith C.H. Zhu Z. DePauw S. Denton M. Boyle M. Multi-attribute and single-attribute utility functions for the Health Utilities Index Mark 3 System Med Care 40 2002 113-128
10. Testa M.A. Nackley J.F. Methods for quality-of-life studies Annu Rev Public Health 15 1994 535-559
11. Stiell I. Nichol G. Wells G. De Maio V. Nesbitt L. Blackburn J. Spaite D. OPALS Study Group Health-related quality of life is better for cardiac arrest survivors who received citizen cardiopulmonary resuscitation Circulation 108 2003 1939-1944
12. www.qolid.org Accessed on December 4, 2003
13. Chassany O. Sagnier P. Marquis P. Fullerton 0S. Aaronson N. for the ERIQA Group Patient reported outcomes and regulatory issues: the example of health-related quality of life. A European guidance document for the improved integration of health-related quality of life (HRQL) assessment in the drug regulatory process Drug Info J 36 2002 209-238
14. Jenkins L.S. Ellenbogen K. Kay N. et al. Quality of life in patients with symptomatic atrial fibrillation Circulation 92 1995 I-490
15. Maglio C. Sra J. Paquette M. Dorian P. Bygrave A. Wood K. Ayers G.M. Measuring quality of life and symptom severity in patients with atrial fibrillation Pacing Clin Electrophysiol 21 1998 839
16. Newman D. Dorian P. Paquette M. Sulke N. Gold M.R. Schwartzman D.S. Schaaf K. Wood K. Johnson L. for the Worldwide Jewel AF-Only Investigators The effect of implantable cardioverter defibrillator with atrial detection and shock therapies on patient-perceived, health-related quality of life Am Heart J 145 2003 841-846
17. Testa M.A. Anderson R.B. Nackley J.F. Hollenberg N.K. Quality of life and antihypertensive therapy in men. A comparison of captopril with enalapril. The Quality-of-Life Hypertension Study Group N Engl J Med 328 1993 907-913
18. Shipper H.S. Clinch J.J. Olewny C.L.M. Quality of life studies: definitions and conceptual issues In: Spilker B. editor. Quality of life and pharmacoeconomics in clinical trials 2nd ed. 1996 11-13 Lippincott-Raven PublishersPhiladelphia
19. Bubien R.S. Knotts-Dolson S.M. Plumb V.J. Kay G.N. Effect of radiofrequency catheter ablation on health-related quality of life and activities of daily living in patients with recurrent arrhythmias Circulation 94 1996 1585-1591
20. Humphries K.H. Kerr C.R. Connolly S.J. Klein G. Boone J.A. Green M. Sheldon R. Talajic M. Dorian P. Newman D. New-onset atrial fibrillation: gender differences in presentation, treatment, and outcome Circulation 103 2001 2365-2370
21. Paquette M. Roy D. Talajic M. Newman D. Couturier A. Yang C. Dorian P. Role of gender and personality on quality-of-life impairment in intermittent atrial fibrillation Am J Cardiol 86 2000 764-768
22. Kerr C.R. Boone J. Connolly S.J. Dorian P. Green M. Klein G. Newman D. Sheldon R. Talajic M. The Canadian Registry of Atrial Fibrillation: a non-interventional follow-up of patients following the first diagnosis of atrial fibrillation Am J Cardiol 82 8A 1998 82N-85N
23. Fitzpatrick A.P. Kourouyan H.D. Siu A. Lee R.J. Lesh M.D. Epstein L.M. Griffin J.C. Scheinman M.M. Quality of life and outcomes after radiofrequency His-bundle catheter ablation and permanent pacemaker implantation: impact of treatment in paroxysmal and established atrial fibrillation Am Heart J 131 1996 499-507
24. Kay G.N. Ellenbogen K.A. Giudici M. Redfield M.M. Jenkins L.S. Mianulli M. Wilkoff B. The Ablate and Pace Trial: a prospective study of catheter ablation of the AV conduction system and permanent pacemaker implantation for treatment of atrial fibrillation J Interv Card Electrophysiol 2 1998 121-135
25. Brignole M. Menozzi C. Gianfranchi L. Musso G. Mureddu R. Bottoni N. Lolli G. Assessment of atrioventricular junction ablation and VVIR pacemaker versus pharmacological treatment in patients with heart failure and chronic atrial fibrillation: a randomized, controlled study Circulation 98 1998 953-960
26. Dorian P. Newman D. Philippon F. Gardner M.J. Talajic M. Sterns L. A randomized pilot study of pacing and ablation vs rate control Can J Cardiol 19 2003 229A
27. Weerasooriya R. Davis M. Powell A. Szili-Torok T. Shah C. Whalley D. Kanagaratnam L. Heddle W. Leitch J. Perks A. Ferguson L. Bulsara M. The Australian Intervention Randomized Control of Rate in Atrial Fibrillation Trial (AIRCRAFT) J Am Coll Cardiol 41 2003 1697-1702
28. Levy T. Walker S. Mason M. Spurrell P. Rex S. Brant S. Paul V. Importance of rate control or rate regulation for improving exercise capacity and quality of life in patients with permanent atrial fibrillation and normal left ventricular function: a randomised controlled study Heart 85 2001 171-178
29. Lau W. Paquette M. Burns M. Dorian P. Gillis A. Newman D. Declining AV junction ablation for paroxysmal atrial fibrillation is associated with pacing in the atrium and improved quality of life in the PA3 trial Pacing Clin Electrophysiol 21 1998 811
30. Newman D. Darling D. Dorian P. Mangat I. Korley V. Buhr T.A. on behalf of the "AF SYMPTOMS" study investigators Patient preferences for rate regularization in AF Can J Cardiol 19 2003 215A
31. Lönnerholm S. Blomström P. Nilsson L. Oxelbark S. Jideus L. Blomström-Lundqvist C. Effects of the maze operation on health-related quality of life in patients with atrial fibrillation Circulation 101 2000 2607-2611
32. Pappone C. Rosanio S. Augello G. Gallus G. Vicedomini G. Mazzone P. Gulletta ?? Gugliotta F. Pappone A. Santinelli V. Tortoriello V. Sala S. Zangrillo A. Crescenzi G. Benussi S. Alfieri O. Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-term study J Am Coll Cardiol 42 2003 185-197
33. Berkowitsch A. Neumann T. Kurzidim K. Reiner C. Kuniss M. Siemon G. Sperzel J. Pitschner H.F. Comparison of generic health survey SF-36 and arrhythmia related symptom severity check list in relation to post-therapy AF recurrence Europace 5 2003 351-355
34. Dorian P. Paquette M. Newman D. Green M. Connolly S. Talajic M. Roy D. Quality of life improves with treatment in the Canadian Trial of Atrial Fibrillation Am Heart J 143 2002 984-990
35. Jenkins L. Quality of life in atrial fibrillation: the AFFIRM study Am Heart J 2004 (in press)
36. Hagens V.E. Ranchor A.V. Van Sonderen E. Bosker H.A. Kamp O. Tijssen J.G. Kingma J.H. Crijns H.J. Van Gelder I.C. RACE Study Group Effect of rate or rhythm control on quality of life in persistent atrial fibrillation. Results from the Rate Control versus Electrical Cardioversion (RACE) Study J Am Coll Cardiol 43 2004 241-247
37. Irvine J. Dorian P. Baker B. O'Brien B. Roberts R. Gent M. Newman D. Connolly S. for the CIDS Investigators Quality-of-life in the Canadian Implantabl Defibrillator Study (CIDS) Am Heart J 144 2002 282-289
38. Newman D. Lau C.P. Tse H.F. Ellenbogen K.A. Buhr T.A. AF SYMPTOMS study investigators Clinical impact of rate regularization in patients with paroxysmal atrial fibrillation Pacing Clin Electrophysiol 26 2003 432
39. Yee R. on behalf of the RASTAF II clinical investigators The RASTAF II Trial: the effects of ventricular rate stabilization pacing on clinical outcome in atrial fibrillation patients Circulation 108 2003 647