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Assessment of the Impact of Notification of Blood Donors Testing Positive for Microbiology Markers: What is the Psychological Impact of Notification and Does the Method of Notification Influence the Outcome?
Sponsor study identifier
observational
217
1 country
1
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2010
Actual (reported)Study Completion
November 2010
Actual (reported)Each year around 200 blood donors in the UK are found to be infected with blood-borne diseases (HIV, hepatitis B, hepatitis C, and HTLV), while several others have been identified as having an increased risk of variant Creutzfeldt-Jakob Disease (vCJD). Although the notification procedures for these infections vary, their effectiveness and appropriateness have never been evaluated in a systematic study. The proposed research has been designed to assess the responses of blood donors to notification and their satisfaction with how they were informed about the infection. The study will be implemented using standard questionnaire-based measures (French et al, 2004; Marteau \& Bekker, 1992). The study will involve approximately 600 blood donors who were informed of an infection or possible infection with blood-borne diseases in 2008 and 2009, and approximately 100 donors notified of possible risk of vCJD infection in 2005. A comparable group of 2005 donors will be included to control for the effects of time. As the majority of donors testing positive donated to NHS Blood and Transplant (NHSBT), the participants will be identified from the NHSBT database only, and their availability confirmed through their GP or specialist clinician. A standardized questionnaire will be then sent to all those identified as eligible. The study will last 12 months, but direct participant involvement will be limited to the time required to complete the questionnaire, which should take under one hour. To safeguard confidentiality, no identifiable personal data will be used in the analysis. Where demographic or medical information already held by NHSBT is retrieved to minimise response burden, this will be pseudonymised before use. The study is sponsored by the blood services for England, Wales, Scotland and Northern Ireland. The results will be used to inform notification procedures in the future.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 14, 2010
Actual (reported)January 18, 2010
Actual (reported)March 2010
Date type not reportedThis date has not been verified as actual or estimated.
October 2010
Actual (reported)November 2010
Actual (reported)The primary outcome measure for the study is the reported level of satisfaction with the notification process, including the information provided and the donor's emotional response.
July-August 2010
Blood donors testing positive for HIV, HBV, HCV or HTLV in 2008 and 2009. Donors notified of increased risk of vCJD in 2005.
All donors testing positive for microbiology markers in 2008 and 2009, and those identified as at risk of vCJD in 2008.
NHS Blood and Transplant, Transfusion Microbiology
Colindale, London, NW9 5BG, United Kingdom
Elam G, Oakley K, Connor N, Hewitt P, Ward HJ, Zaman SM, Chow Y, Marteau TM. Impact of being placed at risk of Creutzfeldt-Jakob disease: a qualitative study of blood donors to variant CJD cases and patients potentially surgically exposed to CJD. Neuroepidemiology. 2011;36(4):274-81. doi: 10.1159/000328646. Epub 2011 Jul 12.
French DP, Maissi E, Marteau TM. Psychological costs of inadequate cervical smear test results. Br J Cancer. 2004 Nov 29;91(11):1887-92. doi: 10.1038/sj.bjc.6602224.
Patricia E Hewitt, FRCP FRCPath
NHS Blood and Transplant
Theresa M Marteau, PhD FMedSci
King's College London
Cameron F Ousbey, MSc
NHS Blood and Transplant
217 participants (actual enrollment reported by the registry).
First Submitted
January 14, 2010
First Posted
January 18, 2010
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Kleinman S, Wang B, Wu Y, Glynn SA, Williams A, Nass C, Ownby H, Busch MP; Retrovirus Epidemiology Donor Study. The donor notification process from the donor's perspective. Transfusion. 2004 May;44(5):658-66. doi: 10.1111/j.1537-2995.2004.03347.x.
Tynell E, Norda R, Ekermo B, Sanner M, Andersson S, Bjorkman A. False-reactive microbiologic screening test results in Swedish blood donors-how big is the problem? A survey among blood centers and deferred donors. Transfusion. 2007 Jan;47(1):80-9. doi: 10.1111/j.1537-2995.2007.01067.x.
Reynolds CA, Brailsford SR, Hewitt PE. Notifying blood donors of infection: results of a donor satisfaction survey. Transfus Med. 2015 Dec;25(6):358-65. doi: 10.1111/tme.12268. Epub 2015 Dec 28.
Primary Completion
October 2010
Actual (reported)Study Completion
November 2010
Actual (reported)Last Updated
May 10, 2022
Record last verified: 2022-05
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