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?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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 information given at notification was retained and implemented. As it is anticipated that all blood donations are to be screened for vCJD as soon as a test becomes available, the need for the development of optimal notification procedures was identified. The proposed study builds on those findings.
Blood donors comprise a unique population, usually characterised by high altruism, low risk-taking, conservatism and concern with health (Simmons et al., 1993; Burnett, 1981). For those reasons, notification of serious infection could cause them greater distress, experience of stigma and self-image damage than an average person (Jackson, 2005; Orsini, 2002; Schulte, 2002; Murray, 1990), and therefore should be handled with utmost care.
Currently, blood donations in the UK are routinely tested for syphilis, hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) and human T-lymphotropic virus (HTLV). Additionally, if indicated by donor history, supplementary tests for malaria, T-cruzi, cytomegalovirus (CMV), and West Nile virus (WNV) are performed. For the purposes of the study, only donors notified of positive test results of routine screening will be surveyed. Those testing positive for syphilis will not be included because of the universally curable nature of the infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •deferred blood donor status, and
- •deferral due to a positive result of a routine blood test for HIV, or hepatitis B, or hepatitis C, or HTLV, or having been identified as at risk of vCJD; and
- •deferral occured in 2008 or 2009 (2007 for the pilot; 2005 for those at risk of vCJD); and
- •donor registered at one of the NHSBT centres (English Blood Service in England and Wales);
排除标准
- •not a blood donor; or
- •no record of notification having taken place; or
- •a member of Armed Forces or other profession where contact at the address provided could lead to a breach of confidentiality; or
- •deferred before 2008 (if not in the pilot or notified of increased risk of vCJD);
- •deferred as a result of a non-routine test or syphilis infection only; or
- •donor registered with and notified by the Welsh, Scottish or Northern Irish Blood Services;
结局指标
主要结局
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.
时间窗: July-August 2010
次要结局
未报告次要终点
