American Journal of Epidemiology Vol. 135, No. 8: 865-874
Copyright © 1992 by The Johns Hopkins University School of Hygiene and Public Health
research-article |
Nonparticipation as a Determinant of Adverse Health Outcomes in a Field Trial of Oral Cholera Vaccines
1International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh
2Division of Epidemiology, Statistics, and Prevention Research, National Institute of Child Health and Human Development Bethesda, MD
3Department of International Health, Johns Hopkins School of Public Health Baltimore, MD
4Enteric Diseases Branch, Centers for Disease Control Atlanta, GA
5Department of Medical Microbiology, University of Göteborg Göteborg, Sweden
Reprint requests to John D. Clemens, M D., Prevention Research Program, National Institute of Child Health and Human Development, Executive Plaza North Building, Room 640, Bethesda, MD 20892
The authors estimated the incidence rates of cholera and death between 1985 and 1988 for 32,642 age- and sex-eligible persons who did not participate in a randomized, placebo-controlled field trial of killed oral cholera vaccines in rural Bangladesh. As compared with 20,744 placebo recipients, the relative risk of cholera for all nonparticipants, adjusted for potentially confounding demographic variables, was 1.20 (95% confidence interval (Cl) 1.03–1.41); this adjusted relative risk reflected elevated adjusted relative risks in nonparticipants who were medically ineligible (RR = 1.65; 95% Cl 1.22–2.22) or refused to participate (RR = 1.19; 95% Cl 1.01–1.41), but not in persons absent at the time of vaccination (RR = 1.00; 95% Cl 0.78–1 28) The adjusted relative risk of death was also elevated in nonparticipants as compared with placebo recipients (RR = 1.28; 95% Cl 1.10–1.48), with the same pattern of adjusted relative risks for different categories of nonparticipants: for ineligible subjects, 2.64 (95% Cl 2.12–3.29); for refusers, 1.20 (95% Cl 1.02–1.41); and for absentees, 0.95 (95% Cl 0.75–1.22). The authors concluded that nonparticipation was associated with clinically cogent adverse health outcomes, but that the magnitude of these associations varied according to the reason for nonparticipation. These findings underscore the caution required in assessing vaccine efficacy with controls who are not vaccinated because of choices made by patients or vaccinators. Am J Epidemiol 1992;135:865–74.
cholera; clinical trials; cooperative behavior; vaccines
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  J. L. Kaufman, R. Pelligra, A. L. Reingold, D. L. Sackett, H. T. Shapiro, E. M. Meslin, and B. Woodward Protection for Human Subjects in Medical Research JAMA, May 10, 2000; 283(18): 2387 - 2390. [Full Text] [PDF]
|
|
|
|
|
|
A. W. Tucker, A. C. Haddix, J. S. Bresee, R. C. Holman, U. D. Parashar, and R. I. Glass Cost-effectiveness Analysis of a Rotavirus Immunization Program for the United States JAMA, May 6, 1998; 279(17): 1371 - 1376. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. Clemens, R. Brenner, M. Rao, N. Tafari, and C. Lowe Evaluating New Vaccines for Developing Countries: Efficacy or Effectiveness? JAMA, February 7, 1996; 275(5): 390 - 397. [Abstract] [PDF]
|
|