Participant Blinding and Gastrointestinal Illness in a Randomized, Controlled Trial of an In-Home Drinking Water Intervention

Colford, John M.; Rees, Judy R.; Wade, Timothy J.; Khalakdina, Asheena; Hilton, Joan F.; Ergas, Isaac J.; Burns, Susan; Benker, Anne; Ma, Catherine; Bowen, Cliff; Mills, Daniel C.; Vugia, Duc J.; Juranek, Dennis D.; Levy, Deborah A.

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Participant Blinding and Gastrointestinal Illness in a Randomized, Controlled Trial of an In-Home Drinking Water Intervention

Jan 2002
By Colford, John M. ; Rees, Judy R. ; Wade, Timothy J. ; ...
Source: Emerg Infect Dis. 8(1):29-36.

[PDF-78.16 KB]

English

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Details:

Alternative Title:

Emerg Infect Dis
Personal Author:

Colford, John M. ; Rees, Judy R. ; Wade, Timothy J. ; Khalakdina, Asheena ; Hilton, Joan F. ; ... More +

Colford, John M. ; Rees, Judy R. ; Wade, Timothy J. ; Khalakdina, Asheena ; Hilton, Joan F. ; Ergas, Isaac J. ; Burns, Susan ; Benker, Anne ; Ma, Catherine ; Bowen, Cliff ; Mills, Daniel C. ; Vugia, Duc J. ; Juranek, Dennis D. ; Levy, Deborah A. Less -
Description:

We conducted a randomized, triple-blinded home drinking water intervention trial to determine if a large study could be undertaken while successfully blinding participants. Households were randomized 50:50 to use externally identical active or sham treatment devices. We measured the effectiveness of blinding of participants by using a published blinding index in which values >0.5 indicate successful blinding. The principal health outcome measured was "highly credible gastrointestinal illness" (HCGI). Participants (n=236) from 77 households were successfully blinded to their treatment assignment. At the end of the study, the blinding index was 0.64 (95% confidence interval 0.51-0.78). There were 103 episodes of HCGI during 10,790 person-days at risk in the sham group and 82 episodes during 11,380 person-days at risk in the active treatment group. The incidence rate ratio of disease (adjusted for the clustered sampling) was 1.32 (95% CI 0.75, 2.33) and the attributable risk was 0.24 (95% CI -0.33, 0.57). These data confirm that participants can be successfully blinded to treatment group assignment during a randomized trial of an in-home drinking water intervention.
Subjects:

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Adolescent Adult Aged Child Double-Blind Method Drinking Feasibility Studies Female Gastrointestinal Diseases Humans Male Middle Aged Pilot Projects Quality Control Questionnaires Research Water Purification Water Supply
Source:

Emerg Infect Dis. 8(1):29-36.
Document Type:

Journal Article
Place as Subject:

California
Location:

North America
Volume:

8
Issue:

1
Collection(s):

Emerging Infectious Diseases
Main Document Checksum:

[+]

urn:sha256:1f8a0e211d2edac0a671edd694c70378f36609408820f20d78da9a14a1a37969
Download URL:

https://stacks.cdc.gov/view/cdc/13744/cdc_13744_DS1.pdf
File Type:

	00-1481_FinalR.nxml	txt
	license.txt	txt

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