Do sick newborn infants benefit from participation in a randomized clinical trial?

Journal of Pediatrics

Volumn 134, Issue 2, 1999, Pages 151-155

  Schmidt, Barbara ^a   Gillie, Pat ^a   Caco, Chris ^a   Roberts, Jeremy ^a   Roberts, Robin ^a  

^a MCMASTER UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANTITHROMBIN;

ACUTE HEART INFARCTION; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DATA ANALYSIS; DRUG SCREENING; FIBRINOLYTIC THERAPY; GESTATIONAL AGE; HUMAN; INFANT; PREMATURITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

EID: 0033036772     PISSN: 00223476     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0022-3476(99)70428-2     Document Type: Article

References (22)

1. 1. Lennox EL, Stiller CA, Morris Jones PH, Kinnier Wilson LM. Nephroblastoma: treatment during 1970-3 and the effect on survival of inclusion in the first MRC trial. Br Med J 1979;2:567-9.
2. 2. Davis S, Wright PW, Schulman SF, Hill LD, Pinkham RD, Johnson LP, et al. Participants in prospective, randomized clinical trials for resected non-small cell lung cancer have improved survival compared with nonparticipants in such trials. Cancer 1985;56:1710-8.
3. 3. Clemens JD, van Loon FF, Rao M, Sack DA, Ahmed F, Chakraborty J, et al. Nonparticipation as a determinant of adverse health outcomes in a field trial of oral cholera vaccines. Am J Epidemiol 1992;135:865-74.
4. 4. Albert SM, Sano M, Marder K, Jacobs DM, Brandt J, Albert M, et al. Participation in clinical trials and long-term outcomes in Alzheimer's disease. Neurology 1997;49:38-43.
5. 5. Jha P, Deboer D, Sykora K, Naylor CD. Characteristics and mortality outcomes of thrombolysis trial participants and nonparticipants: a population-based comparison. J Am Coll Cardiol 1996;27:1335-42.
6. 6. Chaitman BR, Ryan TJ, Kronmal RA, Foster ED, Frommer PL, Killip T, et al. Coronary artery surgery study (CASS): comparability of 10 year survival in randomized and randomizable patients. J Am Coll Cardiol 1990;16:1071-8.
7. 7. King III SB, Barnhart HX, Kosinski AS, Weintraub WS, Lembo NJ, Petersen JY, et al. Angioplasty or surgery for multivessel coronary artery disease: comparison of eligible registry and randomized patients in the EAST trial and influence of treatment selection on outcomes. Am J Cardiol 1997;79:1453-9.
8. 8. Schmidt B, Gillie P, Mitchell L, Andrew M, Caco C, Roberts R. A placebo-controlled randomized trial of antithrombin therapy in neonatal respiratory distress syndrome. Am J Resp Crit Care Med 1998;158:470-6.
9. 9. Kwong MS, Egan EA, Notter RH, Shapiro DL. Double-blind clinical trial of calf lung surfactant extract for the prevention of hyaline membrane disease in extremely premature infants. Pediatrics 1985;76:585-92.
10. 10. Kaplan EL, Meier P. Non-parametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
11. 11. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959;22:719-48.
12. 12. Bifano EM, Miggiani WP, Parker PR. Impact of transfusion guidelines on transfusion practices in premature infants. Pediatr Res 1994;35:216A.
13. 13. Beecher HK. The powerful placebo. JAMA 1955;159:1602-6.
14. 14. Benson H, Epstein MD. The placebo effect. A neglected asset in the care of patients. JAMA 1975:232:1225-7.
15. 15. Smith P, Arnesen H. Mortality in non-consenters in a post-myocardial infarction trial. J Intern Med 1990;228:253-6.
16. 16. Kramer MS, Shapiro SH. Scientific challenges in the application of randomized trials. JAMA 1984;252:2739-45.
17. 17. Marcus SM. Assessing non-consent bias with parallel randomized and nonrandomized clinical trials. J Clin Epidemiol 1997;50:823-8.
18. 18. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276:637-9.
19. 19. Zupancic JAF, Gillie P, Streiner DL, Watts JL, Schmidt B. Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics 1997;99 URL: Http://www.pediatrics.org/cgi/content/full/99/1/e6.
20. 20. Rogers CG, Tyson JE, Kennedy KA, Broyles RS, Hickman JF. Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk. J Pediatr 1998;132:606-11.
21. 21. Harrison H. The principles for family-centered neonatal care. Pediatrics 1993;92:643-50.
22. 22. Lantos JD, Frader J. Extracorporeal membrane oxygenation and the ethics of clinical research in pediatrics. N Engl J Med 1990;323:409-13.