Estimating the duration of ongoing prevention trials

Timothy R. Church; Fred Ederer; Jack S. Mandel; Gavin D. Watt; Mindy S. Geisser

doi:10.1093/oxfordjournals.aje.a116740

Estimating the duration of ongoing prevention trials

Timothy R. Church
, Fred Ederer
, Jack S. Mandel
, Gavin D. Watt
, Mindy S. Geisser

Environmental Health Sciences

Research output: Contribution to journal › Article › peer-review

17 Scopus citations

Abstract

The authors present a method of estimating the duration of ongoing prevention trials, showing how the method was applied to the Colon Cancer Control Study, a University of Minnesota study of occult blood testing undertaken to screen for colorectal cancer in older Minnesotans. In that study, begun in 1975 and ongoing, as in several other recent large prevention trials, it was necessary, after the start of the study, to revise upward the initial estimates of study duration derived from general population experience. The underestimates arose because the planners had not adequately taken various population selection factors into account in estimating the expected number of events in the control group. In this paper, the authors outline a method for estimating control group event rates and study duration requirements (and, in some circumstances, also sample size requirements) of prevention studies, via models of disease-specific and all-cause standardized mortality ratios which adjust for various selection effects. The authors also validate the model for disease-specific standardized mortality ratios by means of independent estimates of disease incidence and case survival.

Original language	English (US)
Pages (from-to)	797-810
Number of pages	14
Journal	American journal of epidemiology
Volume	137
Issue number	7
DOIs	https://doi.org/10.1093/oxfordjournals.aje.a116740
State	Published - Apr 1 1993

Bibliographical note

Funding Information:
Received for publication August 12, 1991, and in final form October 13, 1992. Abbreviations: SEER, Surveillance, Epidemiology, and End Results; SMR, standardized mortality ratio. 1Division of Environmental and Occupational Health, School of Public Health, University of Minnesota, Minneapolis, MN. 2 Division of Btostatistjcs, School of Public Health, University of Minnesota, and The EMMES Corporation, Potomac, MD. Reprint requests to Dr. Timothy R. Church, School of Public Health, University of Minnesota, 212 Ontario Street SE, Suite 202, Minneapolis, MN 55414. This study was supported by contracts from the National Cancer Institute (NOI-CB-61005 and NOK8-95613).

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Clinical trials
Colorectal neoplasms
Epidemiologic methods
Incidence
Mortality
Randomized controlled trials
Research design
Selection bias

Publisher link

10.1093/oxfordjournals.aje.a116740

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title = "Estimating the duration of ongoing prevention trials",

abstract = "The authors present a method of estimating the duration of ongoing prevention trials, showing how the method was applied to the Colon Cancer Control Study, a University of Minnesota study of occult blood testing undertaken to screen for colorectal cancer in older Minnesotans. In that study, begun in 1975 and ongoing, as in several other recent large prevention trials, it was necessary, after the start of the study, to revise upward the initial estimates of study duration derived from general population experience. The underestimates arose because the planners had not adequately taken various population selection factors into account in estimating the expected number of events in the control group. In this paper, the authors outline a method for estimating control group event rates and study duration requirements (and, in some circumstances, also sample size requirements) of prevention studies, via models of disease-specific and all-cause standardized mortality ratios which adjust for various selection effects. The authors also validate the model for disease-specific standardized mortality ratios by means of independent estimates of disease incidence and case survival.",

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author = "Church, \{Timothy R.\} and Fred Ederer and Mandel, \{Jack S.\} and Watt, \{Gavin D.\} and Geisser, \{Mindy S.\}",

note = "Funding Information: Received for publication August 12, 1991, and in final form October 13, 1992. Abbreviations: SEER, Surveillance, Epidemiology, and End Results; SMR, standardized mortality ratio. 1Division of Environmental and Occupational Health, School of Public Health, University of Minnesota, Minneapolis, MN. 2 Division of Btostatistjcs, School of Public Health, University of Minnesota, and The EMMES Corporation, Potomac, MD. Reprint requests to Dr. Timothy R. Church, School of Public Health, University of Minnesota, 212 Ontario Street SE, Suite 202, Minneapolis, MN 55414. This study was supported by contracts from the National Cancer Institute (NOI-CB-61005 and NOK8-95613).",

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N1 - Funding Information: Received for publication August 12, 1991, and in final form October 13, 1992. Abbreviations: SEER, Surveillance, Epidemiology, and End Results; SMR, standardized mortality ratio. 1Division of Environmental and Occupational Health, School of Public Health, University of Minnesota, Minneapolis, MN. 2 Division of Btostatistjcs, School of Public Health, University of Minnesota, and The EMMES Corporation, Potomac, MD. Reprint requests to Dr. Timothy R. Church, School of Public Health, University of Minnesota, 212 Ontario Street SE, Suite 202, Minneapolis, MN 55414. This study was supported by contracts from the National Cancer Institute (NOI-CB-61005 and NOK8-95613).

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N2 - The authors present a method of estimating the duration of ongoing prevention trials, showing how the method was applied to the Colon Cancer Control Study, a University of Minnesota study of occult blood testing undertaken to screen for colorectal cancer in older Minnesotans. In that study, begun in 1975 and ongoing, as in several other recent large prevention trials, it was necessary, after the start of the study, to revise upward the initial estimates of study duration derived from general population experience. The underestimates arose because the planners had not adequately taken various population selection factors into account in estimating the expected number of events in the control group. In this paper, the authors outline a method for estimating control group event rates and study duration requirements (and, in some circumstances, also sample size requirements) of prevention studies, via models of disease-specific and all-cause standardized mortality ratios which adjust for various selection effects. The authors also validate the model for disease-specific standardized mortality ratios by means of independent estimates of disease incidence and case survival.

AB - The authors present a method of estimating the duration of ongoing prevention trials, showing how the method was applied to the Colon Cancer Control Study, a University of Minnesota study of occult blood testing undertaken to screen for colorectal cancer in older Minnesotans. In that study, begun in 1975 and ongoing, as in several other recent large prevention trials, it was necessary, after the start of the study, to revise upward the initial estimates of study duration derived from general population experience. The underestimates arose because the planners had not adequately taken various population selection factors into account in estimating the expected number of events in the control group. In this paper, the authors outline a method for estimating control group event rates and study duration requirements (and, in some circumstances, also sample size requirements) of prevention studies, via models of disease-specific and all-cause standardized mortality ratios which adjust for various selection effects. The authors also validate the model for disease-specific standardized mortality ratios by means of independent estimates of disease incidence and case survival.

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KW - Colorectal neoplasms

KW - Epidemiologic methods

KW - Incidence

KW - Mortality

KW - Randomized controlled trials

KW - Research design

KW - Selection bias

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Estimating the duration of ongoing prevention trials

Abstract

Bibliographical note

UN SDGs

Keywords

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