Clinical Trial: Notification of Donors With Positive Microbiology Markers
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Observational
Official Title: 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 O
Brief Summary:
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 spons
Detailed Summary:
The purpose of the study is to assess the impact of notification of blood donors testing positive for microbiology markers for blood-borne and (mostly) currently incurable infections (hepatitis B, hepatitis C, HIV, HTLV and vCJD). Specifically, the study will focus on donors' responses to being notified of an infection or possible infection, and their satisfaction with the notification process. The data collected will be used to examine predictors of satisfaction and thus help inform notification procedures in the future.
In the UK, all donations are unpaid and voluntary, which is considered to be the safest method of blood collection (WHO Global Database on Blood Safety (GDBS) and Blood Safety Indicators). Out of the 1.9 million UK blood donations in 2008, only 187 (>0.01%) tested positive. With such low incidence and focus on blood safety, the deferred donor management is largely informed by anecdotal evidence and historical developments. The notification process is standardised within each blood service (e.g. NHSBT Management of Donors with Confirmed Positive Microbiological Markers, MPD/MED/009/05), but has never been evaluated in a systematic study. Worldwide, only a handful of studies have approached the issue (Tynell et al, 2007; Kleinman et al, 2004), but have suggested that donors can experience confusion and anxiety as a result of notification. It is therefore possible that current notification procedures do not adequately address the donors' needs.
A recent in-depth qualitative study of the impact of notification of possible increased risk of variant Creutzfeldt-Jacob Disease (vCJD) for public health purposes (Elam et al, awaiting publication) found that notification was a shocking event in most subjects' lives, although it did not have a lasting emotional impact. Several factors influenced how well informati
Sponsor: NHS Blood and Transplant
Current Primary Outcome: 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. [ Time Frame: June-July 2010 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: NHS Blood and Transplant
Dates:
Date Received: January 14, 2010
Date Started: February 2010
Date Completion: October 2010
Last Updated: February 12, 2010
Last Verified: January 2010
