Informed patient consent to participation in cluster randomized trials: An empirical exploration of trials in primary care

Clinical Trials

Volumn 2, Issue 2, 2005, Pages 91-98

  Eldridge, Sandra M ^a   Ashby, Deborah ^b   Feder, Gene S ^a  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CLUSTER ANALYSIS; CONFERENCE PAPER; EMPIRICAL RESEARCH; ETHICS; INFORMED CONSENT; PATIENT PARTICIPATION; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; PUBLICATION; RANDOMIZATION; VALIDATION PROCESS;

BIOMEDICAL RESEARCH; CLUSTER ANALYSIS; GUIDELINES; HUMANS; INFORMED CONSENT; PATIENT SELECTION; PRIMARY HEALTH CARE; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN;

EID: 18344367627     PISSN: 17407745     EISSN: None     Source Type: Journal    
DOI: 10.1191/1740774505cn070oa     Document Type: Conference Paper

References (33)

1. Donner A, Klar N. Design and analysis of cluster randomised trials in health research. London: Arnold, 2000.
2. Edwards SJ, Braunholtz DA, Lilford RJ, Stevens AJ. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ 1999; 318: 1407-409.
3. Hutton JL. Are distinctive ethical principles required for cluster randomised controlled trials? Stat Med 2001; 20: 473-88.
4. Medical Research Council. Cluster randomised trials: Methodological and ethical considerations. MRC Clinical Trials Series. London: Medical Research Council, 2002.
5. Eldridge S, Ashby D, Feder G, Rudnicka AR, Ukoumunne OC. Lessons for cluster randomised trials in the twenty-first century: a systematic review of trials in primary care. Clin Trials 2004; 1: 80-90.
6. Hayden FG, Gubareva LV, Monto AS et al. Inhaled zanamivir for the prevention of influenza in families. Zanamivir Family Study Group. N Engl J Med 2000; 343: 1282-89.
7. Ceesay SM, Prentice AM, Cole TJ et al. Effects on birth weight and perinatal mortality of maternal dietary supplements in rural Gambia: 5 year randomised controlled trial. BMJ 1997; 315: 786-90.
8. erratum appears in BMJ 1997 Nov 1; 315(7116): 1141.
9. Harris MA, Byles JE, Cockburn J, D'Este C. A general practice-based recruitment strategy for colorectal cancer screening. Aust N Z J Public Health 2000; 24: 441-43.
10. Beresford SA, Curry SJ, Kristal AR, Lazovich D, Feng Z, Wagner EH. A dietary intervention in primary care practice: the Eating Patterns Study. Am J Public Health 1997; 87: 610-16.
11. Dahler-Eriksen BS, Lauritzen T, Lassen JF, Lund ED, Brandslund I. Near-patient test for C-reactive protein in general practice: assessment of clinical, organizational, and economic outcomes. Clin Chem 1999;45:478-85.
12. Watson M, Gunnell D, Peters T, Brookes S, Sharp D. Guidelines and educational outreach visits from community pharmacists to improve prescribing in general practice: a randomised controlled trial. J Health Serv Res Policy 2001; 6: 207-13.
13. Williams RB, Boles M, Johnson RE. A patient-initiated system for preventive health care. A randomized trial in community-based primary care practices. Arch Fam Med 1998; 7: 338-45.
14. Gater R, Goldberg D, Jackson G et al. The care of patients with chronic schizophrenia: a comparison between two services. Psychol Med 1997; 27: 1325-36.
15. Fender GR, Prentice A, Gorst T et al. Randomised controlled trial of educational package on management of menorrhagia in primary care: the Anglia menorrhagia education study. BMJ 1999; 318: 1246-50.
16. Hillman AL, Ripley K, Goldfarb N, Nuamah I, Weiner J, Lusk E. Physician financial incentives and feedback: failure to increase cancer screening in Medicaid managed care. Am J Public Health 1998; 88: 1699-701.
17. Dietrich AJ, Tobin JN, Sox CH et al. Cancer early-detection services in community health centers for the underserved. A randomized controlled trial. Arch Fam Med 1998; 7: 320-27.
18. Manfredi C, Crittenden KS, Warnecke R, Engler J, Cho YI, Shaligram C. Evaluation of a motivational smoking cessation intervention for women in public health clinics. Prev Med 1999; 28: 51-60.
19. Modell M, Wonke B, Anionwu E et al. A multidisciplinary approach for improving services in primary care: randomised controlled trial of screening for haemoglobin disorders. BMJ 1998; 317: 788-91.
20. Hogg WE, Bass M, Calonge N, Crouch H, Satenvtein G. Randomized controlled study of customised preventive medicine reminder letters in a community practice. Can Fam Physician 1998; 44: 81-88.
21. Feder G, Griffiths C, Highton C, Eldridge S, Spence M, Southgate L. Do clinical guidelines introduced with practice based education improve care of asthmatic and diabetic patients? A randomised controlled trial in general practices in east London. BMJ 1995; 311: 1473-78.
22. Jolly K, Bradley F, Sharp S et al. Randomised controlled trial of follow up care in general practice of patients with myocardial infarction and angina: final results of the Southampton heart integrated care project (SHIP). The SHIP Collaborative Group. BMJ 1999; 318: 706-11.
23. O'Connell DL, Henry D, Tomlins R. Randomised controlled trial of effect of feedback on general practitioners' prescribing in Australia. BMJ 1999; 318: 507-11.
24. MRC Health Services and Public Health Research Board. A framework for development and evaluation of RCTs for complex interventions to improve health. London: Medical Research Council, 2000.
25. Ilett KF, Johnson S, Greenhill G et al. Modification of general practitioner prescribing of antibiotics by use of a therapeutics adviser (academic detailer). Br J Clin Pharmacol 2000; 49: 168-73.
26. Veninga CC, Lagerlov P, Wahlstrom R et al. Evaluating an educational intervention to improve the treatment of asthma in four European countries. Drug Education Project Group. Am J Respir Crit Care Med 1999; 160: 1254-62.
27. Katzelnick DJ, Simon GE, Pearson SD et al. Randomized trial of a depression management program in high utilizers of medical care. Arch Fam Med 2000; 9: 345-51.
28. Jolly K, Bradley F, Sharp S, Smith H, Mant D. Follow-up care in general practice of patients with myocardial infarction or angina pectoris: initial results of the SHIP trial. Southampton Heart Integrated Care Project. Fam Pract 1998; 15: 548-55.
29. World Medical Association. Declaration of Helsinki. BMJ 1996; 313: 1449-50.
30. The Nuremburg Code. BMJ 1996; 313: 1448.
31. Lilford RJ, Djulbegovic B. Declaration of Helsinki should be strengthened. Equipoise is essential principle of human experimentation. BMJ 2001; 322: 299-300.
32. Onwujekwe O, Shu E, Okonkwo P. Can community leaders' preferences be used to proxy those of the community as a whole? J Health Serv Res Policy 1999; 4: 133-38.
33. Doyal L. Informed consent in medical research. Journals should not publish research to which patients have not given fully informed consent - with three exceptions. BMJ 1997; 314: 1107-11.