Analysing recurrent hospitalizations in heart failure: A review of statistical methodology, with application to CHARM-preserved

European Journal of Heart Failure

Volumn 16, Issue 1, 2014, Pages 33-40

  Rogers, Jennifer K ^a   Pocock, Stuart J ^a   McMurray, John J V ^b   Granger, Christopher B ^c   Michelson, Eric L ^d   Ostergren, Jan ^e   Pfeffer, Marc A ^f   Solomon, Scott D ^f   Swedberg, Karl ^g,h   Yusuf, Salim ⁱ  

^a LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^b UNIVERSITY OF GLASGOW   (United Kingdom)

^c DUKE UNIVERSITY   (United States)

^d ASTRAZENECA   (United Kingdom)

^e KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^f BRIGHAM AND WOMEN S HOSPITAL   (United States)

^g UNIVERSITY OF GOTHENBURG   (Sweden)

^h NATIONAL HEART AND LUNG INSTITUTE   (United Kingdom)

ⁱ HAMILTON HEALTH SCIENCES   (Canada)

Author keywords

Candesartan; Clinical trial; Heart failure; Hospitalization; Recurrent events

Indexed keywords

CANDESARTAN; PLACEBO;

ARTICLE; CONFIDENCE INTERVAL; HAZARD RATIO; HEART FAILURE; HOSPITALIZATION; HUMAN; METHODOLOGY; MORBIDITY; MORTALITY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT DISEASE; STATISTICAL ANALYSIS; TREATMENT OUTCOME;

CANDESARTAN; CLINICAL TRIAL; HEART FAILURE; HOSPITALIZATION; RECURRENT EVENTS;

DATA INTERPRETATION, STATISTICAL; HEART FAILURE; HOSPITALIZATION; HUMANS; MORBIDITY; RISK ASSESSMENT; SURVIVAL RATE; WORLD HEALTH;

EID: 84896941818     PISSN: 13889842     EISSN: 18790844     Source Type: Journal    
DOI: 10.1002/ejhf.29     Document Type: Article

References (22)

1. Freemantle N, Calvert M, Wood J, Eastaugh J, Griffn C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA 2003;289:2554-2559.
2. Conard MW, Heidenreich P, Rumsfeld JS, Weintraub WS, Spertus J, Cardiovascular Outcomes Research Consortium. Patient-reported economic burden and the health status of heart failure patients. J Card Fail 2006;12:369-374.
3. Stewart S, Jenkins A, Buchan S, McGuire A, Capewell S, McMurray JJ. The current cost of heart failure to the National Health Service in the UK. Eur J Heart Fail 2002;4:361-371.
4. Glynn RJ, Buring JE. Ways of measuring rates of recurrent events. BMJ 1996;312:364-367.
5. Andersen PK, Gill RD. Cox's regression model for counting processes: a large sample study. Ann Stat 1982;10:1100-1120.
6. Rogers JK, McMurray JJV, Pocock SJ, Zannad F, Krum H, Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Eplerenone in patients with systolic heart failure and mild symptoms: analysis of repeat hospitalizations. Circulation 2012;126:2317-2323.
7. Ghosh D, Lin DY. Nonparametric analysis of recurrent events and death. Biometrics 2000;56:554-562.
8. Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J 2012;33:176-182.
9. Yusuf S, Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJV, Michelson EL, Olofsson B, Östergren J. Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial. Lancet 2003;362:777-781.
10. Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJV, Michelson EL, Olofsson B, Östergren J, Yusuf S. Effects of candesartan on mortality and morbidity in patients with chronic heart failure: the CHARM-Overall programme. Lancet 2003;362:759-766.
11. McMurray JJV, Östergren J, Swedberg K, Granger CB, Held P, Michelson EL, Olofsson B, Yusuf S, Pfeffer MA. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic taking angiotensin-convertingenzyme inhibitors: the CHARM-Added trial. Lancet 2003;362:767-771.
12. Granger CB, McMurray JJV, Yusuf S, Held P, Michelson EL, Olofsson B, Östergren J, Pfeffer MA, Swedberg K. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function intolerant to angiotensin-converting-enzyme inhibitors: the CHARM-Alternative trial. Lancet 2003;362:772-776.
13. Greenwood M, Yule GU. An inquiry into the nature of frequency distributions representative of multiple happenings with particular reference to the occurrence of multiple attacks of disease or of repeated accidents. J R Stat Soc 1920;83:255-279.
14. Hsu L, Gorfne M, Malone K. On robustness of marginal regression coefficient estimates and hazard functions in multivariate survival analysis of family data when the frailty distribution is mis-specifed. Stat Med 2007;26:4657-4678.
15. Lin DY, Wei LJ. The robust inference for the Cox proportional-hazards model. J Am Stat Assoc 1989;84:1074-1078.
16. Liu L, Huang X. The use of Gaussian quadrature for estimation in frailty proportional-hazards models. Stat Med 2008;27:2665-2683.
17. Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measure in clinical trials. Stat Med 1999;18:1341-1354.
18. Borer JS, Böhm M, Ford I, Komajda M, Tavazzi L, Sendon JL, Alings M, Lopez-de-Sa E, Swedberg K. Effect of ivabradine of recurrent hospitalization for worsening heart failure: the SHIFT Study. Eur Heart J 2012;33:2813-2820.
19. Kohli P, Wallentin L, Reyes E, Horrow J, Husted S, Angiolillo DJ, Ardissino D, Maurer G, Morais J, Nicolau JC, Oto A, Storey RF, James SK, Cannon CP. Reduction in frst and recurrent cardiovascular events with ticagrelor compared with clopidogrel in the PLATO Study. Circulation 2013;127:673-680.
20. McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A, Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail 2012;14:803-869.
21. Solomon SD, Zile M, Pieske B, Voors A, Shah A, Kraigher-Krainer E, Shi V, Bransford T, Takeuchi M, Gong J, Lefkowitz M, Packer M, McMurray JJ, Prospective comparison of ARNI with ARB on Management of heart failUre with preserved ejectioN fracTion (PARAMOUNT) Investigators. The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: a phase 2 double-blind randomised controlled trial. Lancet 2012;380:1387-1395.
22. McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau J, Shi VC, Solomon SD, Swedberg K, Zile MR, on behalf of the PARADIGM-HF Committees and Investigators. Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure: rationale for and design of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail 2013;15:1062-1073.