Design of trials with dying patients: A feasibility study of cluster randomisation versus randomised consent

Palliative Medicine

Volumn 20, Issue 8, 2006, Pages 799-804

  Fowell, A ^a   Johnstone, R ^a   Finlay, I G ^b   Russell, D ^c   Russell, I T ^c  

^a North West Wales NHS Trust ^*  (United Kingdom)

^b CARDIFF UNIVERSITY   (United Kingdom)

^c BANGOR UNIVERSITY   (United Kingdom)

Author keywords

Clinical trials; Cluster randomisation; Crossover trials; Informed consent; Methodology; Palliative care; Randomised consent

Indexed keywords

ANTIEMETIC AGENT;

ADULT; AGED; ARTICLE; CANCER; CANCER PALLIATIVE THERAPY; CANCER PATIENT; CANCER RESEARCH; CLINICAL TRIAL; CLUSTER ANALYSIS; COMPUTER SIMULATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DYING; FEASIBILITY STUDY; FEMALE; HUMAN; INFORMED CONSENT; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; METHODOLOGY; PATIENT CARE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; TERMINAL CARE;

ADULT; AGED; AGED, 80 AND OVER; CLUSTER ANALYSIS; CROSS-OVER STUDIES; FEASIBILITY STUDIES; FEMALE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; PALLIATIVE CARE; RANDOM ALLOCATION; STATE MEDICINE; TERMINALLY ILL;

EID: 33846011446     PISSN: 02692163     EISSN: None     Source Type: Journal    
DOI: 10.1177/0269216306072554     Document Type: Article

References (27)

1. Working Party on Clinical Guidelines in Palliative Care. Changing gear. National Council for Hospice and Specialist Palliative Care Services, 1997.
2. Ellershaw J, Foster A, Murphy D, et al. Developing an integrated care pathway for the dying patient. Eur J Palliat Care 1997; 4: 206-207.
3. Fowell A, Finlay IG, Johnstone R, et al. An integrated care pathway for the last two days of life: Wales-wide benchmarking in palliative care. Int J Palliat Nurs 2002; 8: 566-73.
4. Higginson I. Evidence based palliative care. BMJ 1998; 319: 462-63.
5. Mental Capacity Act 2005. Retrieved from www.opsi.gov.uk/acts/acts2005/ 20050009.htm
6. CRASH Trials Collaborators. Effect of intravenous corticosteroids on death within 14 days in 10,008 adults with clinically significant head injury (MRC CRASH Trial): randomised placebo-controlled trial. Lancet 2004; 364: 1321-28.
7. Ellershaw J, Ward C. Care of the dying patient: the last hours or days of life. BMJ 2003; 326: 30-34.
8. Hardy J. Consent for trials in palliative care. Lancet 2002; 356: S44.
9. Ahmedzai S, Brooks D; Fentanyl Comparative Trial Group. Transdermal fentanyl versus sustained release oral morphine in cancer pain: preference, efficacy and quality of life. J Pain Symptom Manage 1997; 13: 254-61.
10. Jordhoy MS, Fayers P, Saltnes T, et al. Palliative care intervention and death at home: cluster randomised trial. Lancet 2000; 356: 888-93.
11. Cook AM, Finlay IG, Butler-Keating RJ. Recruiting into palliative care trials: lessons from a feasibility study. Palliat Med 2002; 16: 163-65.
12. Grande GE, Todd CJ. Why are trials in palliative care so difficult? Palliat Med 2000; 14: 69-74.
13. Torgerson DJ. Commentary: problems with randomised consent. BMJ 2001; 322: 453.
14. Bravo G, Paquet M, Dubois M-F. Knowledge of the legislation governing proxy consent to treatment and research. J Med Ethics 2003; 29: 44-50.
15. Welie SPK and Berghmans RLP. Inclusion of patients with severe mental illness in Clinical Trials: Issues and recommendations surrounding informed consent. CNS Drugs 2006; 20: 167-83.
16. Medical Research Council. Cluster randomised trials: methodological and ethical considerations. 2002. Retrieved from www.mrc.ac.uk.
17. Zelen M. Randomised consent designs for clinical trials: an update. Stat Med 1990; 9: 645-56.
18. Steiner A, Walsh B, Pickering R, et al. Therapeutic nursing or unblocking beds? A randomised controlled trial of a post-acute intermediate care unit. BMJ 2001; 322: 453-60.
19. Torgerson DJ. Contamination in trials: is cluster randomisation the answer? BMJ 2001; 322: 355-57.
20. Ellershaw J, Smith C, Overill S, et al. Care of the dying: setting standards for symptom control in the last 48 hours of life. J Pain Symptom Manage 2001; 21: 12-17.
21. Fowell A, Johnstone R, Russell D, et al. Frequency of reported symptoms in the last days of life. Palliat Med (Submitted).
22. Back IN. Palliative medicine handbook, third edition. Cambrian, 2001.
23. Cook TD, Campbell DT. Quasi-experimentation: design and analysis issues for field settings. Rand-McNally, 1979.
24. Cassarette K, Karlawish J. Are special guidelines needed for palliative care research? J Pain Symptom Manage 2000; 20: 130-39.
25. Donner A, Birkett N, Buck C. Randomisation by cluster: sample size requirements and analysis. Am J Epidemiol 1981; 114: 906-14.
26. Campbell M, Elbourne D, Altman D. CONSORT statement: extension to cluster randomised trials. Br Med J 2004; 328: 702-708.
27. Medical Research Council. A framework for development and evaluation of complex interventions to improve health. 2000. Retrieved from www.mrc.ac.uk.