The DOI matches its Crossref record; 56 of the 56 references it cites were found in a registry or an index.
Impracticability of Informed Consent in the Registry of the Canadian Stroke Network
Open accessAbstract
BACKGROUND: Government legislators and research ethics boards in some jurisdictions require all patients to give written informed consent before enrollment in clinical registries. However, the effect of such a requirement on the use of clinical registries and the extent to which registry data can be generalized remain uncertain. METHODS: We examined the effectiveness of a comprehensive attempt to obtain informed consent between June 2001 and December 2002 on the overall participation rate and the characteristics of participating patients in the Registry of the Canadian Stroke Network, a prospective registry based at 20 major stroke centers across Canada. RESULTS: The overall participation rate (i.e., the consent rate among all potential participants) was 39.3 percent of 4285 eligible patients during phase 1 of the project (June 2001 through February 2002) and 50.6 percent of 2823 eligible patients during phase 2 (June 2002 through December 2002), despite the presence of neurologic research nurse coordinators at each site. Many patients died or left the hospital before they could be approached for consent. Major selection biases were found; the in-hospital mortality rate was much lower among patients who were enrolled (6.9 percent) than among those who were not enrolled (21.7 percent) (relative risk of in-hospital death, 3.13; 95 percent confidence interval, 2.65 to 3.70; P<0.001). We estimate that approximately 500,000 dollars (Canadian dollars) was spent on consent-related issues during the first two years of the registry. CONCLUSIONS: Obtaining written informed consent for participation in a stroke registry led to important selection biases, such that registry patients were not representative of the typical patient with stroke at each center. These findings highlight the need for legislation on privacy and policies permitting waivers of informed consent for minimal-risk observational research.
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Kanis, J. A., & Kanis, J. A. (1994) · Osteoporosis International · doi:10.1007/bf01622200 · Cited by 2,516
Dean, M., Carrington, M., Winkler, C., Huttley, G. A., Smith, M. W., Allikmets, R., Goedert, J. J., Buchbinder, S. P., Vittinghoff, E., Gomperts, E., et al. (1996) · Science · doi:10.1126/science.273.5283.1856 · Cited by 2,484
Plasma Viral Load and CD4+ Lymphocytes as Prognostic Markers of HIV-1 Infection
Mellors, J. W., Munoz, A., Giorgi, J. V., Margolick, J. B., Tassoni, C. J., Gupta, P., Kingsley, L. A., Todd, J. A., Saah, A. J., Detels, R., et al. (1997) · Annals of Internal Medicine · doi:10.7326/0003-4819-126-12-199706150-00003 · Cited by 2,067
Molecular Cloning and Disease Association of Hepatitis G Virus: A Transfusion-Transmissible Agent
Linnen, J., Wages, J., Zhang-Keck, Z.-Y., Fry, K. E., Krawczynski, K. Z., Alter, H., Koonin, E., Gallagher, M., Alter, M., Hadziyannis, S., et al. (1996) · Science · doi:10.1126/science.271.5248.505 · Cited by 1,359
Alendronate for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis
Saag, K. G., Emkey, R., Schnitzer, T. J., Brown, J. P., Hawkins, F., Goemaere, S., Thamsborg, G., Liberman, U. A., Delmas, P. D., Malice, M.-P., et al. (1998) · New England Journal of Medicine · doi:10.1056/nejm199807303390502 · Cited by 1,258
KASLOW, R. A., OSTROW, D. G., DETELS, R., PHAIR, J. P., POLK, B. F., RINALDO, C. R., & STUDY, F. T. M. A. C. (1987) · American Journal of Epidemiology · doi:10.1093/aje/126.2.310 · Cited by 1,194
Detels, R. (1998) · JAMA · doi:10.1001/jama.280.17.1497 · Cited by 739
O'Connor, G. T. (1996) · JAMA: The Journal of the American Medical Association · doi:10.1001/jama.1996.03530350023029 · Cited by 726
Use of Tissue-Type Plasminogen Activator for Acute Ischemic Stroke: The Cleveland Area Experience
Katzan, I. L., Furlan, A. J., Lloyd, L. E., Frank, J. I., Harper, D. L., Hinchey, J. A., Hammel, J. P., Qu, A., & Sila, C. A. (2000) · JAMA · doi:10.1001/jama.283.9.1151 · Cited by 648
Genant, H. K., Jergas, M., Palermo, L., Nevitt, M., Valentin, R. S., Black, D., & Cummings, S. R. (1996) · Journal of Bone and Mineral Research · doi:10.1002/jbmr.5650110716 · Cited by 643
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Self-citationEuropean Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions
Mentzelopoulos, S. D., Couper, K., Voorde, P. V. D., Druwé, P., Blom, M., Perkins, G. D., Lulic, I., Djakow, J., Raffay, V., Lilja, G., et al. (2021) · Resuscitation · doi:10.1016/j.resuscitation.2021.02.017 · Cited by 246
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Metadata
- Authors
- Tu, J. V., Willison, D. J., Silver, F. L., Fang, J., Richards, J. A., Laupacis, A., & Kapral, M. K.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2004-04
- Volume
- 350
- Issue
- 14
- Pages
- 1414-1421
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2009899617
- Cited by
- 422
- References
- 56
- FWCI
- 34.79
- Type
- journal article
- Language
- en
- Open access
- bronze
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