Use and interpretation of composite end points in orthopaedic trials

Journal of Bone and Joint Surgery

Volumn 94, Issue SUPPL. 1, 2012, Pages 65-69

  Busse, Jason W ^a   Bhandari, Mohit ^b   Ferreira Gonzaĺez, Ignacio ^c   Montori, Victor M ^d   Guyatt, Gordon H ^b  

^a INSTITUTE FOR WORK AND HEALTH   (Canada)

^b MCMASTER UNIVERSITY   (Canada)

^c HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^d MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BONE TRANSPLANTATION; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL (TOPIC); COMPARTMENT SYNDROME; COMPOSITE END POINT; DEATH; DECISION MAKING; FASCIOTOMY; FRACTURE HEALING; FRACTURE NONUNION; HUMAN; INFECTION; INFECTION RISK; INTRAMEDULLARY NAILING; MORTALITY; ORTHOPEDIC CLINICAL TRIAL; ORTHOPEDICS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REOPERATION; REVIEW; RISK FACTOR; RISK REDUCTION; SURGEON; TIBIA FRACTURE; VALIDITY; ARTICLE; BIOASSAY; METHODOLOGY; ORTHOPEDIC SURGERY; REPRODUCIBILITY; RISK; STATISTICAL ANALYSIS; STATISTICS;

DATA INTERPRETATION, STATISTICAL; ENDPOINT DETERMINATION; HUMANS; ORTHOPEDIC PROCEDURES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; RISK;

EID: 84866914603     PISSN: 00219355     EISSN: 15351386     Source Type: Journal    
DOI: 10.2106/JBJS.K.01287     Document Type: Review

References (28)

1. Chan S, Bhandari M. The quality of reporting of orthopaedic randomized trials with use of a checklist for nonpharmacological therapies. J Bone Joint Surg Am. 2007;89:1970-8. (Pubitemid 350195028)
2. Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA. 2003;289:2554-9. (Pubitemid 37430157)
3. Montori VM, Permanyer-Miralda G, Ferreira-González I, Busse JW, Pacheco-Huergo V, Bryant D, Alonso J, Akl EA, Domingo-Salvany A, Mills E, Wu P, SchünemannHJ, Jaeschke R, Guyatt GH. Validity of composite end points in clinical trials. BMJ. 2005;330:594-6. (Pubitemid 40380357)
4. Ferreira-González I, Permanyer-Miralda G, Busse JW, Bryant DM, Montori VM,Alonso-Coello P, Walter SD, Guyatt GH. Methodologic discussions for using and interpreting composite endpoints are limited, but still identify major concerns. J Clin Epidemiol. 2007;60:651-7. Epub 2007 Feb 23.
5. Neaton JD, Gray G, Zuckerman BD, Konstam MA. Key issues in end point selection for heart failure trials: composite end points. J Card Fail. 2005;11:567-75. (Pubitemid 41463726)
6. Braunwald E, Cannon CP, McCabe CH. An approach to evaluating thrombolytic therapy in acute myocardial infarction. The 'unsatisfactory outcome' end point. Circulation. 1992;86:683-7.
7. Moyé LA. Multiple analyses in clinical trials: fundamentals for investigators. NewYork: Springer-Verlag; 2003.
8. Lewis JA. Statistical principles for clinical trials (ICH E9): an introductory note on an international guideline. Stat Med. 1999;18:1903-42.
9. Gent M. Discussion: some issues in the construction and use of clusters of outcome events. Control Clin Trials. 1997;18:546-9. (Pubitemid 27520842)
10. Cannon CP. Clinical perspectives on the use of composite endpoints. Control Clin Trials. 1997;18:517-29. (Pubitemid 27520840)
11. Hallstrom AP, Litwin PE, Weaver WD. A method of assigning scores to the components of a composite outcome: an example from the MITI trial. Control Clin Trials. 1992;13:148-55.
12. Lubsen J, Kirwan BA. Combined endpoints: can we use them? Stat Med. 2002; 21:2959-70.
13. Carneiro AV. Composite outcomes in clinical trials: uses and problems. Rev Port Cardiol. 2003;22:1253-63.
14. Lauer MS, Topol EJ. Clinical trials -multiple treatments, multiple end points, and multiple lessons. JAMA. 2003;289:2575-7. (Pubitemid 37430160)
15. Chi GY. Some issues with composite endpoints in clinical trials. Fundam Clin Pharmacol. 2005;19:609-19. (Pubitemid 43821995)
16. Myerburg RJ, Castellanos A. Language and interpretation of clinical trial outcomes: alternates, surrogates, and composites. Heart Rhythm. 2004;1:538-9. (Pubitemid 39467710)
17. O'Connor CM, Gattis WA, Ryan TJ. The role of clinical nonfatal end points in cardiovascular phase II/III clinical trials. Am Heart J. 2000;139:S143-54. (Pubitemid 30207809)
18. DeMets DL, Califf RM. Lessons learned from recent cardiovascular clinical trials: Part I. Circulation. 2002;106:746-51. (Pubitemid 34851937)
19. Pocock SJ. Clinical trials with multiple outcomes: a statistical perspective on their design, analysis, and interpretation. Control Clin Trials. 1997;18:530-45. (Pubitemid 27520841)
20. Gensini GF, Conti AA. The evaluation of the results of clinical trials: surrogate end points and composite end points. Minerva Med. 2004;95:71-5. (Pubitemid 38667806)
21. Bland JM, Altman DG. Multiple significance tests: the Bonferroni method. BMJ. 1995;310:170.
22. Rothman KJ. No adjustments are needed for multiple comparisons. Epidemiol. 1990;1:43-6. (Pubitemid 20255621)
23. Poolman RW, Struijs PA, Krips R, Sierevelt IN, Marti RK, Farrokhyar F, Bhandari M. Reporting of outcomes in orthopaedic randomized trials: does blinding of outcome assessors matter? J Bone Joint Surg Am. 2007;89:550-8. (Pubitemid 46365355)
24. Guyatt GH, Mills EJ, Elbourne D. In the era of systematic reviews, does the size of an individual trial still matter. PLoS Med. 2008;5:e4.
25. Ferreira-González I, Busse JW, Heels-Ansdell D, Montori VM, Akl EA, Bryant DM,Alonso-Coello P, Alonso J, Worster A, Upadhye S, Jaeschke R, Schünemann HJ,Permanyer-Miralda G, Pacheco-Huergo V, Domingo-Salvany A, Wu P, Mills EJ, Guyatt GH. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ. 2007;334:786. Epub 2007 Apr 2.
26. Tengs TO, Wallace A. One thousand health-related quality-of-life estimates. Med Care. 2000;38:583-637.
27. Lim E, Brown A, Helmy A, Mussa S, Altman DG. Composite outcomes in cardiovascular research: a survey of randomized trials. Ann Intern Med. 2008;149:612-7.
28. Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures Investigators, Bhandari M, Guyatt G, Tornetta P 3rd, Schemitsch EH, Swiontkowski M, Sanders D, Walter SD. Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures. J Bone Joint Surg Am. 2008;90:2567-78.