title: Improving venous ulcer healing: designing and reporting randomised controlled trials.
abstract: The randomised controlled trial (RCT) is often considered the gold standard for judging the benefits of treatments. The application of randomised controlled clinical trials to treatments of venous ulcer healing has lagged behind that of other areas of medicine. To interpret the results of an RCT, readers must understand a variety of aspects of their design, analysis and interpretation. Venous ulcer disease has a high prevalence and has a significant socioeconomic impact in most parts of the world. The management of venous ulcers causes a considerable strain on the health system and is likely to worsen in future. The multi-layer high compression system is described as the current gold standard for treating venous ulcers. A recent meta-analysis of bandaging systems found that multi-layer compression bandages appeared to be superior to single-layer bandages in promoting venous ulcer healing. However, it was noted that many of the studies had small sample sizes and the quality of research in the area was poor. The consolidating standards of reporting trials (CONSORT) statement can help clinicians to discern high-quality studies from ones of poorer quality. This paper discusses how CONSORT can help clinicians and researchers to design and report quality studies to contribute to evidence-based venous ulcer healing.
authors.affiliation: Department of Epidemiology and Preventative Medicine, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia. carolina.weller@med.monash.edu.au
authors.forename: Carolina D
authors.initials: CD
authors.lastname: Weller
authors.forename: John
authors.initials: J
authors.lastname: McNeil
authors.forename: Sue
authors.initials: S
authors.lastname: Evans
authors.forename: Christopher
authors.initials: C
authors.lastname: Reid
mesh_terms: D006801:Humans; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D012107:Research Design / Q000592:standards; D014647:Varicose Ulcer / Q000628:therapy*; D014945:Wound Healing
references.citation: Lancet. 2002 Feb 23;359(9307):696-700
references.pmid: 11879884
references.citation: Vasc Med. 1998;3(4):301-13
references.pmid: 10102671
references.citation: BMJ. 1996 Jan 13;312(7023):71-2
references.pmid: 8555924
references.citation: Lancet. 2001 Apr 14;357(9263):1191-4
references.pmid: 11323066
references.citation: AJR Am J Roentgenol. 2004 Dec;183(6):1539-44
references.pmid: 15547188
references.citation: JAMA. 1995 Feb 1;273(5):408-12
references.pmid: 7823387
references.citation: Br J Surg. 2004 Oct;91(10):1292-9
references.pmid: 15382102
references.citation: BMJ. 2006 Apr 22;332(7547):962-5
references.pmid: 16627516
references.citation: BMJ. 2008 Mar 15;336(7644):601-5
references.pmid: 18316340
references.citation: Ann Intern Med. 2001 Dec 4;135(11):982-9
references.pmid: 11730399
references.citation: Lancet. 1998 Aug 22;352(9128):609-13
references.pmid: 9746022
references.citation: Health Technol Assess. 2001;5(9):1-221
references.pmid: 11368833
references.citation: Health Technol Assess. 2000;4(21):1-237
references.pmid: 11074391
references.citation: BMJ. 1997 Sep 6;315(7108):576-80
references.pmid: 9302954
references.citation: Ann Intern Med. 2004 Nov 16;141(10):781-8
references.pmid: 15545678
references.citation: Wound Repair Regen. 2003 May-Jun;11(3):166-71
references.pmid: 12753596
references.citation: Med J Aust. 2007 Mar 19;186(6):318-9
references.pmid: 17371216
references.citation: Lancet. 2002 Feb 16;359(9306):614-8
references.pmid: 11867132
references.citation: Int Wound J. 2008 Jun;5(2):159-71
references.pmid: 18494622
references.citation: JAMA. 1996 Aug 28;276(8):637-9
references.pmid: 8773637