Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: Systematic review

BMJ (Online)

Volumn 341, Issue 7781, 2010, Pages 1034-

  Rahimi, Kazem ^a   Malhotra, Aneil ^a   Banning, Adrian P ^a   Jenkinson, Crispin ^b  

^a JOHN RADCLIFFE HOSPITAL   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL DECISION MAKING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DEATH; FUNCTIONAL STATUS; HUMAN; MORBIDITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; SYSTEMATIC REVIEW; TREATMENT OUTCOME;

CARDIOVASCULAR DISEASES; DATA COLLECTION; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PERIODICALS AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; TIME FACTORS;

EID: 78349261942     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.c57075     Document Type: Article

References (33)

1. Clarke M. Standardising outcomes for clinical trials and systematic reviews. Trials 2007;8:39.
2. Quality of life and clinical trials. Lancet 1995;346:1-2.
3. Acquadro C, Berzon R, Dubois D, Leidy NK, Marquis P, Revicki D, et al. Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health 2003;6:522-31.
4. McDermott MM, Liu K, Guralnik JM, Martin GJ, Criqui MH, Greenland P. Measurement of walking endurance and walking velocity with questionnaire: Validation of the walking impairment questionnaire in men and women with peripheral arterial disease. J Vasc Surg 1998;28:1072-81.
5. 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;4:101-7. (Pubitemid 19081188)
6. Sanders C, Egger M, Donovan J, Tallon D, Frankel S. Reporting on quality of life in randomised controlled trials: bibliographic study. BMJ 1998;317:1191-4.
7. Veldhuyzen Van Zanten SJ. Quality of life as outcome measures in randomized clinical trials. An overview of three general medical journals. Control Clin Trials 1991;12(4 suppl):234-42S.
8. Tawakol A, Migrino RQ, Aziz KS, Waitkowska J, Holmvang G, Alpert NM, et al. High-dose folic acid acutely improves coronary vasodilator function in patients with coronary artery disease. J Am Coll Cardiol 2005;45:1580-4.
9. Von Beckerath N, Taubert D, Pogatsa-Murray G, Schomig E, Kastrati A, Schomig A. Absorption, metabolization, and antiplatelet effects of 300-, 600-, and 900-mg loading doses of clopidogrel: results of the ISAR-CHOICE (intracoronary stenting and antithrombotic regimen: Choose between 3 high oral doses for immediate clopidogrel effect) trial. Circulation 2005;112:2946-50.
10. Haahr M. Random.org, 2009.
11. Gandhi GY, Murad MH, Fujiyoshi A, Mullan RJ, Flynn DN, Elamin MB, et al. Patient-important outcomes in registered diabetes trials. JAMA 2008;299:2543-9.
12. Ferreira-Gonzalez I, Busse JW, Heels-Ansdell D, Montori VM, Akl EA, Bryant DM, et al. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ 2007;334:786.
13. Panzini I, Fioritti A, Gianni L, Tassinari D, Canuti D, Fabbri C, et al. Quality of life assessment of randomized controlled trials. Tumori 2006;92:373-8.
14. Guyatt GH, Veldhuyzen Van Zanten SJ, Feeny DH, Patrick DL. Measuring quality of life in clinical trials: a taxonomy and review. CMAJ 1989;140:1441-8.
15. Ganz PA, Moinpour CM, Cella DF, Fetting JH. Quality-of-life assessment in cancer clinical trials: a status report. J Natl Cancer Inst 1992;84:994-5.
16. Kaasa S. Measurement of quality of life in clinical trials. Oncology 1992;49:289-94.
17. Pocock SJ. A perspective on the role of quality-of-life assessment in clinical trials. Control Clin Trials 1991;12(4 suppl):257-65S.
18. Normand S-LT, Rector TS, Neaton JD, Piña IL, Lazar RM, Proestel SE, et al. Clinical and analytical considerations in the study of health status in device trials for heart failure. J Card Fail 2005;11:396-403.
19. Wenger NK, Mattson ME, Furberg CD, Elinson J. Assessment of quality of life in clinical trials of cardiovascular therapies. Am J Cardiol 1984;54:908-13. (Pubitemid 14006171)
20. Gotay CC, Korn EL, McCabe MS, Moore TD, Cheson BD. Quality-of-life assessment in cancer treatment protocols: research issues in protocol development. J Natl Cancer Inst 1992;84:575-9.
21. Lesperance F, Frasure-Smith N, Koszycki D, Laliberte M-A, van Zyl LT, Baker B, et al. Effects of citalopram and interpersonal psychotherapy on depression in patients with coronary artery disease: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) trial.[see comment][erratum appears in JAMA 2007 Jul 4;298:40]. JAMA 2007;297:367-79.
22. Jourdain P, Jondeau G, Funck F, Gueffet P, Le Helloco A, Donal E, et al. Plasma brain natriuretic peptide-guided therapy to improve outcome in heart failure. The STARS-BNP Multicenter Study. J Am Coll Cardiol 2007;49:1733-9.
23. Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes.[see comment]. N Engl J Med 2007;357:2001-15.
24. Unger EF. Weighing benefits and risks - The FDA's review of Prasugrel. N Engl J Med 2009;361:942-5.
25. Campbell DJ, Krum H, Esler MD. Losartan increases bradykinin levels in hypertensive humans. Circulation 2005;111:315-20.
26. Schomig A, Mehilli J, Antoniucci D, Ndrepepa G, Markwardt C, Di Pede F, et al. Mechanical reperfusion in patients with acute myocardial infarction presenting more than 12 hours from symptom onset: a randomized controlled trial.[see comment]. JAMA 2005;293:2865-72.
27. Contopoulos-Ioannidis DG, Karvouni A, Kouri I, Ioannidis JP. Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review. BMJ 2009;338:a3006.
28. Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781-8.
29. Rao SV, O'Grady K, Pieper KS, Granger CB, Newby LK, Mahaffey KW, et al. A comparison of the clinical impact of bleeding measured by two different classifications among patients with acute coronary syndromes. J Am Coll Cardiol 2006;47:809-16.
30. DeMets DL, Califf RM. Lessons learned from recent cardiovascular clinical trials: part I. Circulation 2002;106:746-51.
31. Feeny D. Preference-based measures: utility and quality adjusted life years. In: Fayers P, Hays R, eds. Assessing quality of life in clinical trials. 2nd ed. Oxford University Press, 2005:405-28.
32. Spertus JA. Evolving applications for patient-centered health status measures. Circulation 2008;118:2103-10.
33. Fayers P, Machin D. Quality of life: the assessment, analysis and interpretation of patient-reported outcomes. 2nd ed. Wiley Blackwell, 2007.