Notification of Donors With Positive Microbiology Markers
Condition: Human Immunodeficiency Virus; Hepatitis B; Hepatitis C; Human T-lymphotropic Virus I & II; Creutzfeldt-Jakob Syndrome
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis B; Acquired Immunodeficiency Syndrome; HIV Infections; Creutzfeldt-Jakob Syndrome; Hepatitis
Study type: Observational

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 sponsored by the blood services for England, Wales, Scotland and Northern
      Ireland. The results will be used to inform notification procedures in the future.
    

Detailed description: 
      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.

      A mail out questionnaire was chosen as the best form of data collection because of the
      significant dispersion of the study population, the continuity of contact method, and the low
      intrusiveness of the instrument. Those wishing to participate will be able to complete the
      questionnaire at a time and place most convenient to them. As initial communication was by
      letter, it is expected that a mail out survey accompanied by a cover letter will be
      accessible to most donors. A telephone- and a web-based survey completion option will also be
      offered to facilitate access.

      The questionnaire will focus on three main areas of interest, namely satisfaction, emotional
      response and understanding. These were identified from the in-depth vCJD study, donor records
      and literature review as the issues most pertinent to the notification process, and ones
      influenced by the manner in which information is provided. Personal characteristics and
      circumstances will not be considered, as they are already well researched from the
      perspective of coping (Kaye & Raghavan, 2002; Baile et al., 2000; Kraus et al., 2000; Buckman
      & Kason, 1992), and not controlled for in blood donation, thus limiting their usefulness for
      informing donor notification process.

      To ensure the appropriateness and feasibility of questions, and to avoid misrepresentation,
      the survey will be piloted with a small sample of donors testing positive in routine
      screening in 2007.

      The return of a completed questionnaire will be treated as implied consent, and the return of
      an empty one with or without the opt-out option selected will be taken to signify the donor's
      decision not to give such consent.

      The main risk identified in contacting positive donors is re-traumatisation, and a helpline
      number will be provided to allow those experiencing any distress to discuss their situation.
      It is hoped, however, that as the infections under study are chronic, re-traumatisation would
      be rare and minimal. It is further hoped that the character of the project, which aims to aid
      the development of notification procedures that would be the most satisfactory to donors
      receiving positive test results in the future, would be welcome by most subjects as an
      opportunity to engage in an activity that could be of benefit to others. Should any donor's
      reaction suggest that their situation may be serious, every attempt will be made to offer
      follow-up care. Any aggravating issues inherent in the questionnaire itself, however, will
      hopefully be identified and rectified at the piloting stage. The direct donor burden, should
      they choose to participate in the study, should be limited to the 20-30 minutes needed to
      complete the questionnaire.

      Only the Principal Investigator and the researcher will have access to identifiable personal
      data, the PI as a member of the donor's healthcare team, and the researcher within the remit
      of the position. The researcher's access to and use of donor records will comply with the
      Good Clinical Practice guidelines, and further with the NHS Confidentiality Code of Practice.
      Donor name and number will be coded and stored separately from the pseudonymised survey data.
      The file linking donor identifiable information with codes will be stored for the duration of
      the research project only. The raw survey data file and returned questionnaires will be
      stored securely for a minimum of 2 years. Only the pseudonymised data will be used for
      analysis, and no identifiable donor information will be included in ensuing reports.

      The demographic data such as age, ethnicity and sex already available in the donor records
      will be pseudonymised and used to reduce response burden. Only the data theoretically
      relevant to the study will be included. The access to all study files will be restricted, and
      all information will be stored and shared securely as per NHS guidelines. No identifiable
      personal data will be shared.

      The survey data will be statistically analysed using SPSS. Every attempt will be made to
      assess the extent of the non-response error using pseudonymised demographic data of the
      non-respondents. Due to the large number of variables involved, main attention will be given
      to descriptive statistics.

      To avoid misinterpretation, any conclusions drawn from the data will be discussed by the
      Project Management Group and not made by the researcher in isolation. The results of the
      study will be published and accessible to the participants and general public in this way, or
      if requested directly.

      Both the PI and the researcher are the employees of the NHSBT. The proposed research project
      is funded by the four UK blood services, and aims to improve the service offered. It will
      consider all responses, and use them to the benefit of the service users; however, it is
      intended to investigate the responses of blood donors who have donated in England or North
      Wales only. Due to the unique characteristics of this group, without further study the
      results cannot be generalised to the entire UK population or to other countries.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All donors testing positive for microbiology markers in 2008 and 2009, and those identified
        as at risk of vCJD in 2008.
      
Keywords: blood donor notification; emotional response; variant Creutzfeldt-Jacob Disease