Implementation of sexual risk behavior donor screening in Canada.

BACKGROUND: The two Canadian blood suppliers, Canadian Blood Services and Héma-Québec, removed the time-based deferral for men who have sex with men and adopted criteria assessing sexual risk behaviors. We report the impact of these changes on the safety and adequacy of the Canadian blood supply. STUDY DESIGN AND METHODS: Since 2022, all donors are asked if (1) they have had a new partner and (2) more than one sexual partner in the last 3 months. Donors answering yes to either question are asked if they had anal sex in the last 3 months; if yes, they are deferred for 3 months. We followed HIV rates for the 18 months before and 14 (Héma-Québec) or 18 months (Canadian Blood Services) post-implementation and interviewed HIV-positive whole blood donors. We assessed the number and characteristics of whole blood donors answering yes to the two first questions with or without deferral. RESULTS: There were four HIV-positive donations out of 1,492,355 donations pre-implementation and four out of 1,447,772 post-implementation (0.27/100,000 vs. 0.28/100,000, p = 1.00). Post-implementation, one HIV-positive donor was non-compliant with multiple criteria, no risk factors were identified in the others. 3.2% of donors answered yes to questions (1) and/or (2); 0.17% were deferred for a new partner and/or more than one partner and anal sex. Deferral rates were highest in first time, younger donors, and similar in males and females. CONCLUSION: Implementation of sexual risk behavior donor screening resulted in unchanged HIV rates to date and a manageable deferral rate.

End of selection criteria based on sexual orientation: An international symposium on alternatives to donation deferral.

BACKGROUND AND OBJECTIVES: Until recently, gay, bisexual and other men who have sex with men (MSM) were deferred from donating blood for 3-12 months since the last male-to-male sexual contact. This MSM deferral has been discontinued by several high-income countries (HIC) that now perform gender-neutral donor selection. MATERIALS AND METHODS: An international symposium (held on 20-04-2023) gathered experts from seven HICs to (1) discuss how this paradigm shift might affect the mitigation strategies for transfusion-transmitted infections and (2) address the challenges related to gender-neutral donor selection. RESULTS: Most countries employed a similar approach for implementing a gender-neutral donor selection policy: key stakeholders were consulted; the transition was bridged by time-limited deferrals; donor compliance was monitored; and questions or remarks on anal sex and the number and/or type of sexual partners were often added. Many countries have now adopted a gender-neutral approach in which questions on pre- and post-exposure prophylaxis for human immunodeficiency virus (HIV) have been added (or retained, when already in place). Other countries used mitigation strategies, such as plasma quarantine or pathogen reduction technologies for plasma and/or platelets. CONCLUSION: The experience with gender-neutral donor selection has been largely positive among the countries covered herein and seems to be acceptable to stakeholders, donors and staff. The post-implementation surveillance data collected so far appear reassuring with regards to safety, although longer observation periods are necessary. The putative risks associated with HIV antiretrovirals should be further investigated.

Genitourinary Syndrome of Menopause in Cancer Survivors.

Genitourinary syndrome of menopause (GSM) encompasses the symptoms of estrogen deprivation in the vaginal, vulva, and bladder areas. Because many cancer treatments induce a hypoestrogenic state, GSM is common in cancer survivors. The number of cancer survivors is increasing, and the unique aspects of GSM management for cancer survivors, such as the safety of hormonal therapies, is important to understand. In this review, we cover important considerations in the assessment of GSM; nonpharmacologic, behavioral, integrative, pharmacologic, and medical device treatments for GSM: the unique considerations in GSM by cancer treatment modality; bladder manifestations of GSM; and GSM in specific populations.

Monitoring syphilis serology in blood donors: Is there utility as a surrogate marker of early transfusion transmissible infection behavioral risk?

BACKGROUND: In Canada the time deferral for gay, bisexual, and other men who have sex with men (gbMSM) was progressively shortened (lifetime, 5 years, 1 year, 3 months). Here we describe trends in syphilis rates (a potential sexual risk marker) and risk behaviors from blood donors in the past 12 years. STUDY DESIGN AND METHODS: Syphilis positivity in 10,288,322 whole blood donations (January 1, 2010-September 10, 2022) and gbMSM deferral time periods, donation status, age, and sex were analyzed with logistic regression. Overall, 26.9% syphilis positive and 42.2% controls (matched 1:4) participated in risk factor interviews analyzed by logistic regression. RESULTS: Syphilis rates were higher in first-time donors (OR 27.0, 95% CI 22.1-33.0), in males (OR 2.3, 1.9-2.8) and with the 3-month deferral (OR 3.4, 2.6-4.3) during which the increase was greater for first-time males (p < .001) but similar for male and female repeat donors (p > .05). Among first-time donors, histories of intravenous drug use (OR 11.7, 2.0-69.5), male-to-male sex 7.8 (2.0-30.2) and birth in a high prevalence country (OR 7.6, 4.4-13.0) predicted syphilis positivity; among repeat donors, history of male-to-male sex (OR 33.5, CI 3.5-317.0). All but 1 gbMSM syphilis-positive donors were noncompliant with the gbMSM deferral. About a quarter of first-time interviewed case donors had history of syphilis; 44% were born in a high-prevalence country. CONCLUSION: Rising syphilis rates in donors correlates with the general population epidemic. Recent infection rates rose similarly in males and females. GbMSM history may contribute to donor syphilis rates but shortening time deferrals appears unrelated.

Navigating imperfect policies to donate plasma: Survey on plasma donation and a pilot plasma donation program among men who have sex with men in Canada.

BACKGROUND: In 2021, Canada implemented a pilot plasma program allowing some sexually active men who have sex with men (including but not limited to gay and bisexual men; gbMSM) to donate plasma. Changes to plasma donation policy could help address inequities in access to plasma donation and increase Canada's domestically collected plasma supply if more gbMSM donate as a result. We aimed to (1) examine views regarding plasma donation and the pilot program prior to implementation and (2) identify modifiable theory-informed predictors of gbMSM's intention to donate plasma. METHODS: We developed, piloted, and disseminated a questionnaire informed by the Theoretical Domains Framework (TDF). We recruited gbMSM in London (ON) and Calgary (AB) to an anonymous, online cross-sectional survey. RESULTS: A total of 246 gbMSM completed the survey. On scales from 1 (strongly disagree) to 5 (strongly agree), general intention to donate was high (mean = 4.24; SD = 0.94). The pilot program itself was mostly acceptable (mean = 3.71, SD = 1.16), but the intention to donate under the unique requirements of the pilot program was lower than general intention (mean = 3.58; SD = 1.26). Two domains from the theoretical domains framework (TDF) (beliefs about consequences of donating plasma and social influences) were independently associated with general intention to donate. DISCUSSION: The pilot plasma program as an incremental step toward more inclusive policies was mostly viewed as acceptable by the impacted communities. Historical and ongoing exclusions create unique barriers to donation. There are clear opportunities for developing theory-informed interventions to support gbMSM to donate plasma as policies continue to become more inclusive and more become eligible to donate.

NCCN Guidelines® Insights: Survivorship, Version 1.2023.

The NCCN Guidelines for Survivorship are intended to help healthcare professionals address the complex and varied needs of cancer survivors. The NCCN Guidelines provide screening, evaluation, and treatment recommendations for psychosocial and physical problems resulting from adult-onset cancer and its treatment; recommendations to help promote healthy behaviors and immunizations in survivors; and a framework for care coordination. These NCCN Guidelines Insights summarize recent guideline updates and panel discussions pertaining to sleep disorders, fatigue, and cognitive function in cancer survivors.

Medication use in Canadian blood donors.

BACKGROUND AND OBJECTIVES: Policies regarding medication use vary between blood centres. We evaluated medication use in eligible Canadian Blood Services whole blood donors to inform possible process improvements and allow comparisons between donors and the general population. MATERIALS AND METHODS: All donors are asked about medication use in the last 3 days, and medications and their reason for use are documented in our donor computer system. Donor computer records were reviewed from January 1, 2020, to March 31, 2022 to extract information on medications by donor age and sex; medications were grouped into therapeutic classes. Stability of medication use over time was determined in a random sample of 100 donors who made at least two donations in the study period. RESULTS: One-third of successful (eligible) donors were taking medications; of these, 80% were on one or two medications. Five classes of medication accounted for 72% of medication use, and 13 classes account for 93% of use. Use remains relatively stable over time. CONCLUSION: Medication use is common, with a few classes accounting for most use. Drop-down lists and storage of information from one donation to the next may enhance efficiency.

Use of selective phenotyping and genotyping to identify rare blood donors in Canada.

BACKGROUND AND OBJECTIVES: The distribution of rare and specific red cell phenotypes varies between races and ethnicities. Therefore, the most compatible red cell units for patients with haemoglobinopathies and other rare blood requirements are most likely to be found in donors from similar genetic backgrounds. Our blood service introduced a voluntary question asking donors to provide their racial background/ethnicity. Results triggered additional phenotyping and/or genotyping. MATERIALS AND METHODS: We analysed the results of additional testing performed between January 2021 and June 2022, and rare donors were added to the Rare Blood Donor database. We determined the incidence of various rare phenotypes and blood group alleles based on donor race/ethnicity. RESULTS: Over 95% of donors answered the voluntary question; 715 samples were tested, and 25 donors were added to the Rare Blood Donor database, including five k-, four U-, two Jk(a-b-) and two D- - phenotypes. CONCLUSION: Asking donors about their race/ethnicity was well received by donors, and the resulting selective testing enabled us to identify individuals with a higher likelihood of being rare blood donors, support patients with rare blood requirements and better understand the incidence of common and rare alleles and red blood cell phenotypes in the Canadian donor population.

Evolving the gay, bisexual and other men who have sex with men time-based deferral to sexual risk screening for all donors: The contribution of Canadian research programmes.

BACKGROUND AND OBJECTIVES: In Canada, the time deferral for gay, bisexual and other men who have sex with men (gbMSM) to donate blood has gradually decreased. In September 2022, this deferral was replaced with sexual behaviour-based screening for all donors. We investigate how data from targeted research programmes addressed knowledge gaps to support this change. MATERIALS AND METHODS: We conducted a scoping review describing the Canadian literature available before the research programmes relating to (1) behavioural indicators of HIV risk and (2) attitudes to blood donation among gbMSM, current donors and the general population. We summarize the targeted research programmes, their outputs and impact to date. RESULTS: For question 1, five projects met inclusion criteria. For question 2, three articles met inclusion criteria. Knowledge gaps identified were insufficient evidence of HIV incidence in gbMSM who met other donor eligibility criteria and scant data on opinions and views of blood donation and screening criteria for sexual risk behaviours. The research programmes funded 19 projects at 11 different research sites involving over 100 individual researchers/collaborators resulting in 19 peer-reviewed publications to date. Leveraging existing gbMSM cohorts yielded relevant HIV incidence data to inform safety modelling studies. Findings indicated that sexual behaviour-based screening was acceptable to gbMSM and donors, and donor discomfort around specific questions could be mitigated with clear explanations. CONCLUSION: Targeted research programmes filled critical knowledge gaps and informed a change to gender-neutral, sexual behaviour-based screening for all donors. Findings supported successful implementation of these changes with research-informed staff training.

Improved access yet inequitable experience: gay, bisexual and other men who have sex with men's views of more inclusive criteria for source plasma donation.

BACKGROUND: Canada has incrementally reduced restrictions to blood and plasma donation that impact men who have sex with men, gay, bisexual, and queer men, and some Two Spirit, transgender and non-binary individuals (MSM/2SGBTQ+). Prior to the launch of a pilot program in 2021 enabling some MSM/2SGBTQ + to donate source plasma, we explored the acceptability of the program among individuals who could become eligible to donate in the program. METHODS: We invited men identifying as MSM/2SGBTQ + to participate in two consecutive semi-structured interviews to explore their views on blood and plasma donation policy, plasma donation, and the proposed Canadian plasma donation program. Interview transcripts were analyzed thematically and acceptability-related themes were mapped onto the Theoretical Framework of Acceptability. RESULTS: Twenty-seven men identifying as having sex with men participated in 53 interviews. Eighteen themes were mapped onto the seven construct domains of the Theoretical Framework of Acceptability. Underlying all aspects of acceptability was a tension between four primary values influencing participants' views: altruism, equity, supply sufficiency, and evidence-based policy. The program was viewed as welcome progress on a discriminatory policy, with many excited to participate, yet tension with inequitable aspects of the program undermined support for the program and interest to contribute to it. The high demands of the program are unique for MSM/2SGBTQ + and are only tolerable as part of a program that is an incremental and instrumental step to more equitable donation policies. CONCLUSION: Findings highlight past experiences of exclusion in Canada as a unique and critical part of the context of the donation experience among MSM/2SGBTQ+. Despite the program's goals of greater inclusivity of MSM/2SGBTQ + individuals, the anticipated experience of the program included continued stigmatization and inequities. Future research should seek to understand the experienced views of MSM/2SGBTQ + donors to ensure that as policies change, policies are implemented equitably.

How do we decide how representative our donors are for public health surveillance?

BACKGROUND: Surveillance of blood donors is fundamental to safety of the blood supply. Such data can also be useful for public health policy but tend to be underutilized. When the COVID-19 pandemic arrived, blood centers around the world measured blood donor SARS-CoV-2 seroprevalence to inform public health policy. There is now a movement toward blood centers becoming more involved in public health research and surveillance post-pandemic. However, blood donors are a healthy population and not representative of all segments of the general population. In this article, we explain how blood centers can evaluate their donor base to understand which part of the general population they are representative of. STUDY DESIGN AND METHODS: Methodologic approaches for evaluating samples relative to the target population were reviewed. Blood donor data that are available to most blood centers were identified and application to assess representativeness of blood donors was evaluated. RESULTS: Key aspects of blood donor data to compare with general population data include donor selection criteria, health indicators, geography, and demographics. In some cases, statistical adjustment can improve representativeness. DISCUSSION: Comparing key blood donor data with corresponding general population data can define the subset of the general population for which a particular blood center's donors may be representative of. We suggest that donors are an ideal convenience population for surveillance of infectious agents which are frequently asymptomatic and main routes of transmission are not deferrable, for studying the natural history of disease in an initially well population, and for vaccination serology surveillance.

HIV incidence and compliance with deferral criteria over three progressively shorter time deferrals for men who have sex with men in Canada.

BACKGROUND: In Canada, the deferral for men who have sex with men (MSM) has been progressively reduced from a permanent deferral for MSM since 1977, to 5 years, 1 year, and, most recently, 3 months. We estimated human immunodeficiency virus (HIV) residual risk and compliance with the MSM time deferral after each change. METHODS: Four anonymous online compliance surveys were carried out before and after each change. HIV incidence and prevalence were monitored from 2010 to 2021. Residual risk was estimated using the incidence-window period model. RESULTS: Human immunodeficiency virus prevalence, incidence, and residual risk did not change with incrementally shorter MSM deferrals. The residual risk per million donations post 3-month deferral was 0.05 (0.001-0.371). Men with temporally remote MSM history became eligible and, therefore, compliant as the deferral periods decreased (Cochran-Armitage p value = <.0001). However, the percentage of men with MSM history in the last 3 months with the indefinite deferral in place was similar to the percentage noncompliant, while the 3-month deferral was in place. MSM donors did not report high-risk behaviors for which they would otherwise be deferred in any survey. Following the change, an estimated 4467 MSM per year were eligible to donate, an increase from 2501 estimated eligible MSM donors following the change to the 1-year deferral. CONCLUSION: With progressively shorter MSM deferral periods, HIV residual risk was unchanged. The proportion of male donors with deferrable MSM history remained low, while those with temporally remote MSM history became eligible, increasing the number of eligible MSM donors.

Staff perspectives on barriers and enablers to implementing alternative source plasma eligibility criteria for gay, bisexual, and other men who have sex with men.

BACKGROUND: Canadian Blood Services introduced new eligibility criteria that allows some sexually active gay, bisexual, and other men who have sex with men (gbMSM) to donate source plasma, marking a significant change from time-based deferral criteria. We aimed to identify potential barriers and enablers to implementing the new criteria from the perspective of donor center staff. STUDY DESIGN AND METHODS: We conducted Theoretical Domains Framework-informed interviews with staff from two source plasma donation centers in Canada. RESULTS: We completed 28 interviews between June 2020 and April 2021. Three themes representing eight domains captured key tensions. Valuing inclusive eligibility criteria: staff support inclusive criteria; many were concerned the new criteria remained discriminatory. Investing in positive donor experiences: staff wished to foster positive donor experiences; however, they worried gbMSM donors would express anger and disappointment regarding the new criteria, staff would experience unease over using stigmatizing criteria and convey nonverbal cues of discomfort, and recurring plasma donors may behave inappropriately. Supporting education, training, and transparency of eligibility criteria: participants believed providing in-person training (i.e., to explain criteria rationale, address discomfort, practice responding to donor questions) and ensuring donors and the public were well-informed of the upcoming changes would improve implementation. DISCUSSION: Participant views emphasize the importance of supporting staff through training and transparent communication to optimize the delivery of world-class equitable care for a new cohort of donors who have previously been excluded from plasma donation. Findings inform which staff supports to consider to improve implementation as policies continue to shift internationally.

NCCN Guidelines® Insights: Survivorship, Version 1.2022.

The NCCN Guidelines for Survivorship are intended to help healthcare professionals who work with survivors to ensure that the survivors' complex and varied needs are addressed. The NCCN Guidelines provide screening, evaluation, and treatment recommendations for the consequences of adult-onset cancer and its treatment; recommendations to help promote physical activity, weight management, and immunizations in survivors; and a framework for care coordination. This article summarizes updates to the NCCN Guidelines pertaining to preventive health for cancer survivors, including recommendations about alcohol consumption and vaccinations.

The impact of donor ferritin testing on blood availability in Canada.

BACKGROUND AND OBJECTIVES: Iron depletion is a side effect of blood donation. Agencies have developed policies to test donors and to extend inter-donation intervals (IDIs) for individuals with low ferritin levels. Ferritin testing, however, has an impact on product availability due to longer IDIs and the effect of test results on donor behaviour. In this paper we apply a model to evaluate the impact of ferritin testing in the Canadian donor population on whole blood donations. MATERIALS AND METHODS: A discrete event simulation was adopted for the study. The model represents a population of individuals that donate blood, are tested for ferritin levels, and may exit the system. Data for the simulation was derived from operational data, donor research studies from Canadian Blood Services and previously published sources. RESULTS: Red cell collections will decline by at least 3.1% and could decline by as much as 19.2% after ferritin testing is put in place. Requirements for new donors could rise by as much as 36.0%. CONCLUSION: The impact of ferritin testing on repeat donor behaviour, rather than extensions to the mandated inter-donation interval, is the largest factor influencing declines in whole blood donations. Because behaviour changes following the receipt of a low ferritin result, blood agencies must ensure that donors with low ferritin are motivated to modify their lifestyle and, when healthy, return to the donor pool.

Evolving policies for donors with diabetes: The Canadian experience.

BACKGROUND AND OBJECTIVES: Donor criteria for diabetes vary significantly. We describe our evolving policies for donors with diabetes, their contribution to the Canadian blood supply and their rate of syncopal reactions compared to other donors. MATERIALS AND METHODS: All donors are asked if they have diabetes and have taken medications in the last 3 days. We assessed donors with diabetes on various medications, the number deferred over time, and syncopal reactions in donors with diabetes and other donors in our donor reaction database. RESULTS: Policy changes allowing type 2 diabetic donors on oral hypoglycaemics alone, type 2 diabetic donors on oral medications and insulin and type 1 diabetic donors (all on insulin) to donate resulted in a decrease in deferrals from 450 to 22 donors annually. Of donors being treated with medication for diabetes, 11% are receiving insulin as part of their treatment. Syncopal reaction rates were low and not statistically different between diabetic and non-diabetic donors, although confidence intervals (CIs) are large. CONCLUSION: Policies decreased deferrals while maintaining safety. A longer observation period would strengthen these observations.

Blood donor eligibility criteria for medical conditions: A BEST collaborative study.

BACKGROUND AND OBJECTIVES: Donor eligibility questions and criteria for medical conditions vary between blood centres, suggesting that they are based more on local regulations or experience, rather than on published data, which are limited. As the donor population ages, medical conditions become more common. We assessed donor health assessment criteria at blood centre members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. Our aim was to compare eligibility criteria and determine their underlying basis. MATERIALS AND METHODS: A REDCap survey was sent to blood centre participants, based on medical conditions of greatest interest suggested by the Donor Studies Team of the BEST Collaborative. Participants were asked about current donor health assessment questions, deferral criteria and the basis for their deferral policy (donor risk, recipient risk or both) for 20 medical conditions. RESULTS: Complete responses were received from 26 blood donor centres (24 separate responses) representing a combination of hospital-based centres, large regional centres and community/national blood centres in 14 different countries. Most centres specifically ask about heart and lung conditions, whereas fewer than half inquire about kidney, gastrointestinal or neurological conditions. North American blood centres tended to be less restrictive, while regulatory restrictions are more prevalent in Europe. Most participants felt that the criteria were based on regulatory requirements or experience, rather than on published data. CONCLUSION: There is considerable variability in criteria by region. Ideally, criteria would be more evidence-based rather than based on regulatory requirements or experience. Deferral criteria must balance donor and recipient safety and maintain an adequate blood supply.

Whole blood donor return rates after deferral for tattooing or body piercing-Survey across blood donation services: The BEST collaborative study.

BACKGROUND AND OBJECTIVES: To protect transfusion recipients from transfusion-transmissible infections, blood donors are deferred from donating after recent tattooing or piercing. To explore to what extent and how this deferral impacts donor availability, we performed an international study to investigate how many donors were deferred for a recent tattoo or piercing and how many of these donors returned to donate. MATERIALS AND METHODS: We surveyed blood centre members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative and the European Blood Alliance Donor Studies Working Group on their numbers of donations, tattoo and piercing deferrals, and return rates in the year 2017. RESULTS: Eight blood centres participated. Overall, deferral rates were lower for repeat donors compared to new donors. Repeat donors were more likely to return than new donors. Women and young donors were more often deferred than male and older donors. Men were more demotivated by tattoo or piercing deferral, resulting in lower return rates compared to women. Return rates differed greatly between blood centres. CONCLUSION: Tattoo and piercing deferrals lead to missed donations and result in lower return rates. However, the numbers vary largely internationally, probably due to cultural and policy differences. Shortening deferral periods after tattooing or piercing may reduce the impact on donor availability, which should be investigated in single-centre studies.

Behaviour based screening questions and potential donation loss using the "for the assessment of individualised risk" screening criteria: A Canadian perspective.

BACKGROUND: To reduce the risk of HIV transmission through transfusion, gay, bisexual and other men who have sex with men (gbMSM) are deferred from donating blood in many countries for varying lengths of time after having sex with another man. In 2021, screening algorithms to identify high-risk sexual behaviours using gender-neutral criteria (i.e., without any question on MSM or time deferral for MSM) were implemented in the United Kingdom based on recommendations in a report from the FAIR (For the Assessment of Individualised Risk) steering group. OBJECTIVES: This study examines the potential donation loss expected with these criteria if implemented in Canada. METHODS: Responses from blood donors regarding engagement in behaviours such as chemsex and anal sex with a new or multiple partners within 3 months of donation were collected using an on-site paper questionnaire. RESULTS: Applying the FAIR criteria resulted in donation loss of 1.0% (95% CI: 0.8% - 1.1%). Donation loss would be higher amongst younger donors aged 17-25 (2.0%, 95% CI: 1.6% - 2.3%). Overall, 20% of donors reported feeling uncomfortable answering study questions but only 2.0% said it would stop them from donating. CONCLUSION: Donation loss could be compensated by newly eligible gbMSM and with increased recruitment and encouraging donation from infrequent donors.

How do I think about blood donor eligibility criteria for medical conditions?

Every blood center must determine blood donor eligibility criteria for donors with medical conditions, often based on very limited published data and variable practice. This manuscript briefly outlines possible impacts of donor medical conditions on donor and recipient safety and product quality, and describes the multidisciplinary approach used in Canada to think about donor criteria issues. Many years of experience are distilled into practical considerations in determining criteria, possible sources of information, and factors for successful change implementation, to hopefully assist medical and technical staff engaged in decision-making around donor eligibility.