Should Zelen pre-randomised consent designs be used in some neonatal trials?

Journal of Medical Ethics

Volumn 25, Issue 4, 1999, Pages 325-329

  Allmark, Peter ^a  

^a NONE

Author keywords

ECMO; Neonatology; Pre randomisation; Research; Zelen

Indexed keywords

ARTICLE; EXTRACORPOREAL OXYGENATION; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; METHODOLOGY; NEONATOLOGY; NEWBORN; PATIENT INFORMATION; PULMONARY HYPERTENSION; RANDOMIZATION;

EID: 0032854629     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.25.4.325     Document Type: Article

References (25)

1. Zelen M. Randomized consent designs for clinical trials: an update. Statistics in Medicine 1990;9:645-56.
2. O'Rourke P, Crone R, Vacanti J, Ware J, Lillihei C, Parad R, et al. A prospective randomized study of extracorporeal membrane oxygenation and conventional medical therapy in neonates with persistent pulmonary hypertension of the newborn. Pediatrics 1989;84:957-63; Bartlett R, Roloff D, Cornell R, Andrews A, Dillon P, Zwischenberger S. Extracorporeal circulation in neonatal respiratory failure: a prospective randomized trial. Pediatrics 1985;76:479-87.
3. O'Rourke P, Crone R, Vacanti J, Ware J, Lillihei C, Parad R, et al. A prospective randomized study of extracorporeal membrane oxygenation and conventional medical therapy in neonates with persistent pulmonary hypertension of the newborn. Pediatrics 1989;84:957-63; Bartlett R, Roloff D, Cornell R, Andrews A, Dillon P, Zwischenberger S. Extracorporeal circulation in neonatal respiratory failure: a prospective randomized trial. Pediatrics 1985;76:479-87.
4. UK Collaborative ECMO Trial Group. Extra-corporeal membrane oxygenation (ECMO): the UK collaborative neonatal ECMO trial. Lancet 1996;348:75-82. See also discussion in: Anonymous. Your baby is in a trial [editorial]. Lancet 1995;345: 805-6 and correspondence Lancet 1995;345:1370-1.
5. UK Collaborative ECMO Trial Group. Extra-corporeal membrane oxygenation (ECMO): the UK collaborative neonatal ECMO trial. Lancet 1996;348:75-82. See also discussion in: Anonymous. Your baby is in a trial [editorial]. Lancet 1995;345: 805-6 and correspondence Lancet 1995;345:1370-1.
6. Burton P, Gurrin L, Hussey M. Interpreting the clinical trials of extracorporeal membrane oxygenation in the treatment of persistent pulmonary hypertension of the newborn. Seminars in Neonatology 1997;2:69-79.
7. Troug R. Randomized controlled trials: lessons from ECMO. Clinical Research 1992;40:519-27.
8. Tobias J. BMJ's present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. British Medical Journal 1997;314:1111-14; and: Tobias J. Fully informed consent can be needlessly cruel. British Medical Journal 1993;307:1199-201.
9. Tobias J. BMJ's present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. British Medical Journal 1997;314:1111-14; and: Tobias J. Fully informed consent can be needlessly cruel. British Medical Journal 1993;307:1199-201.
10. Doyal L. Journals should not publish research to which patients have not given fully informed consent-with three exceptions. British Medical Journal 1997;314:1107-11; Emberton M, Wood C, Meredith P. Informed consent in clinical trials should be comprehensive [letter]. British Medical Journal 1993;307:1494.
11. Doyal L. Journals should not publish research to which patients have not given fully informed consent-with three exceptions. British Medical Journal 1997;314:1107-11; Emberton M, Wood C, Meredith P. Informed consent in clinical trials should be comprehensive [letter]. British Medical Journal 1993;307:1494.
12. Snowdon C, Garcia J, Elbourne D. Making sense of randomization; responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Social Science in Medicine 1997;45:1337-55.
13. For example: Modi N. Informed consent difficult in paediatric intensive care [letter]. British Medical Journal 1993;307:1495; Eden O. Consent difficult in paediatric oncology [letter]. British Medical Journal 1994;308:272; Baum M. Reactionary approach inhibits progress [letter]. British Medical Journal 1994;308:271.
14. For example: Modi N. Informed consent difficult in paediatric intensive care [letter]. British Medical Journal 1993;307:1495; Eden O. Consent difficult in paediatric oncology [letter]. British Medical Journal 1994;308:272; Baum M. Reactionary approach inhibits progress [letter]. British Medical Journal 1994;308:271.
15. For example: Modi N. Informed consent difficult in paediatric intensive care [letter]. British Medical Journal 1993;307:1495; Eden O. Consent difficult in paediatric oncology [letter]. British Medical Journal 1994;308:272; Baum M. Reactionary approach inhibits progress [letter]. British Medical Journal 1994;308:271.
16. 10 See reference 1:648.
17. The Euricon project, with which I am involved.
18. For example: Altman D, Whitehead J, Parmar M, Stenning S, Payers P, Machin D. Randomised consent designs in cancer clinical trials. European Journal of Cancer 1995;31A:1934-44; Parmar M. Randomization before consent: practical and ethical considerations. In: Williams C, ed. Introducing new treatments for cancer: practical, ethical and legal problems. Chichester: Wiley, 1992:189-201. I take these statistical objections as given as the statistics itself is "beyond my ken".
19. For example: Altman D, Whitehead J, Parmar M, Stenning S, Payers P, Machin D. Randomised consent designs in cancer clinical trials. European Journal of Cancer 1995;31A:1934-44; Parmar M. Randomization before consent: practical and ethical considerations. In: Williams C, ed. Introducing new treatments for cancer: practical, ethical and legal problems. Chichester: Wiley, 1992:189-201. I take these statistical objections as given as the statistics itself is "beyond my ken".
20. Botros S. The ethics of randomised clinical trials. In Byrne J, ed. Ethics and law in health care research. Chichester: Wiley, 1990:9-24.
21. See reference 7: Doyal:1108.
22. 15 Although see the point concerning resource problems in the section on patient preference designs, below.
23. See reference 6: Tobias, (1997):1200.
24. Brewin C, Bradley C. Patient preferences and randomised clinical trials. British Medical Journal 1989;299:313-5.
25. Meran J. Ethics of consent for babies in randomised clinical trials. Lancet 1995;345:1370.