Design of randomized controlled trials in the treatment of leg ulcers: More answers with fewer patients

Phlebology

Volumn 13, Issue 3, 1998, Pages 107-112

  Prescott, R J ^a,e   Nelson, E A ^b   Dale, J J ^c   Harper, D R ^d   Ruckley, C V ^c  

^a UNIVERSITY OF EDINBURGH   (United Kingdom)

^b UNIVERSITY OF YORK   (United Kingdom)

^c ROYAL INFIRMARY OF EDINBURGH   (United Kingdom)

^d NHS FORTH VALLEY   (United Kingdom)

^e UNIVERSITY OF EDINBURGH   (United Kingdom)

Author keywords

Bandages; Dressings; Drug therapy; Factorial design; Leg ulcer; Randomized controlled trials; Research design; Treatment protocols

Indexed keywords

PENTOXIFYLLINE; PLACEBO;

ADULT; AGED; ARTICLE; BANDAGE; CASE REPORT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; EVALUATION; FEMALE; HUMAN; HYDROCOLLOID; LEG ULCER; MAJOR CLINICAL STUDY; MALE; METHODOLOGY; OUTCOMES RESEARCH; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKIN ULCER; UNITED KINGDOM; WOUND DRESSING; WOUND HEALING;

EID: 0032469883     PISSN: 02683555     EISSN: None     Source Type: Journal    
DOI: 10.1177/026835559801300305     Document Type: Article

References (23)

1. Neugebauer E, Troidl H, Spangenberger W, Dietrich A, Lefering R and the Cholecystectomy Study Group. Conventional versus laparoscopic Cholecystectomy and the randomized controlled trial. Br J Surg 1991;78:150-4.
2. Bradbury AW, Ruckley CV. Angioplasty for lower-limb ischaemia: time for randomized controlled trials. Lancet 1996;347:277-8.
3. Jackson GH, Lennard AL, Taylor PRA, Carey P, Angus B, Lucraft H, et al. Autologous bone marrow transplantation in poor-risk high-grade non-Hodgkin's lymphoma in first complete remission. Br J Cancer 1994;70:501-5.
4. Blair SD, Wright DDI, Backhouse CM, Riddle E, McCollum CN. Sustained compression and healing of chronic venous ulcers. Br Med J 1988;297:1159-62.
5. Moffatt CJ, Franks PJ, Oldroyd M, Bosanquet N, Brown P, Greenhalgh RM, McCollum CN. Community clinics for leg ulcers and impact on healing. Br Med J 1992;305:1390-2.
6. Sacks H, Chalmers TC, Smith H. Randomized versus historical controls for clinical trials. Am J Med 1982;72:233-40.
7. Grace ND, Muench H, Chalmers TC. The present status of portal hypertension in cirrhosis. Gastroenterology 1966;50:694-91.
8. Foulds GA. Clinical research in psychiatry. J Mental Sci 1958;104:259-65.
9. McGinn FP, Miles AJG, Uglow M, Ozmen M, Terzi C, Humby M. Randomized trial of laparoscopic cholecystectomy and minicholecystectomy. Br J Surg 1995;82:1374-7.
10. Pocock SJ. Clinical trials: a practical approach. Chichester: John Wiley, 1983.
11. Yates F. The design and analysis of factorial experiments. Imperial Bureau of Soil Science Technical Communication no. 35:1937.
12. Silagy CA, Jewell D. Review of 39 years of randomized controlled trials in the British Journal of General Practice [review]. Br J Gen Pract 1994;44:359-63.
13. Truelove SC. Stilboestrol, phenobarbitone and diet in chronic duodenal ulcer: a factorial therapeutic trial. Br Med J 1960;ii:559-66.
14. Cox DR. Planning of experiments. New York: John Wiley, 1958.
15. Callam MJ, Harper DR, Dale JJ, Brown D, Gibson B, Prescott RJ, Ruckley CV. Lothian and Forth Valley Leg Ulcer Healing Trial, Part 1: Elastic versus non-elastic bandaging in the treatment of chronic venous ulceration. Phlebology 1992;7:136-41.
16. Callam MJ, Harper DR, Dale JJ, Brown D, Gibson B, Prescott RJ, Ruckley CV. Lothian and Forth Valley Leg Ulcer Healing Trial, Part 2: Knitted viscose dressing a hydrocellular dressing in the treatment of chronic leg ulceration. Phlebology 1992;7:142-5.
17. Atlman DG. How large a sample? In: Gore SM, Altman DG, editors. Statistics in practice. London: British Medical Association, 1982:21-4.
18. Nelson EA, Ruckley CV, Harper DR, Gibson B, Dale JJ, Prescott RJ. A randomised trial of knitted viscose dressing and a hydrocolloid dressing in the treatment of chronic venous ulceration. In: Negus D, editor. Phlebology 95. London: Springer-Verlag, 1995:913-4.
19. Dale JJ, Ruckley CV, Harper DR, Gibson B, Nelson EA, Prescott RJ. A randomised double-blind placebo controlled trial of pentoxifylline in the treatment of venous leg ulcers. In: Negus D, editor. Phlebology 95. London: Springer-Verlag, 1995:917-8.
20. Nelson EA, Harper DR, Ruckley CV, Prescott RJ, Gibson B, Dale JJ. A randomised trial of single layer and multilayer bandaging in the treatment of chronic venous ulceration. In: Negus D, editor. Phlebology 95. London: Springer-Verlag, 1995:852.
21. The Steering Committee of the Physicians' Health Study Research Group. Preliminary report: findings from the asprin component of the ongoing Physicians' Health Study. New Engl J Med 1988;321:129-35.
22. Hennekens CH, Buring JE, Manson JE, Stempfer M, Rosner B, Cook NR, et al. Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease. New Engl J Med 1996;334:1145-9.
23. Finney DJ. An introduction to the theory of experimental design. Chicago and London: University of Chicago Pess, 1960.