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.

Prevalence of Hepatitis B in Canadian First-Time Blood Donors: Association with Social Determinants of Health.

Hepatitis B is transmitted sexually, by blood contact, and vertically from mother to child. Chronic hepatitis B is often seen in immigrants from higher-prevalence countries and their Canadian-born children. We assessed the relationship between hepatitis B and social determinants of health. Included were 1,539,869 first-time Canadian blood donors from April 2005 to December 2022. All donations were tested for hepatitis B markers. Logistic regression was fit with chronic hepatitis B as the dependent variable and age, sex, year, and ethnocultural composition and material deprivation quintiles as independent variables. Chronic hepatitis B prevalence was 47.5/100,000 (95% CI 41.5-53.5, years 2017-2022). Chronic hepatitis B prevalence was elevated in males, older age groups, and those living in more materially deprived and higher ethnocultural neighbourhoods. Of 212,518 donors from 2020 to 2022 with race/ethnicity data, chronic hepatitis B prevalence was highest in East Asians. The findings are consistent with infections in immigrants, acquired in their country of origin, in their Canadian-born children and in those with other risks. As blood donors are a low-risk population unaware of their infection and unlikely to seek testing, our results highlight the ongoing public health challenges of diagnosing chronic hepatitis B and treating it when appropriate.

Medication Deferrals in Blood Donors.

Medication use is extremely common in blood donors. Blood centers use various methods to obtain a history of medication use, all of which have strengths and weaknesses. Some data are available to develop policies for medications that impact product quality, transmissible disease testing, and infectious risks. Many blood centers defer donors for use of a small number of highly teratogenic medications, as a precautionary measure. Others also defer for possible harms related to the pharmacologic effects of medications. However, a single exposure to a blood component containing medication, with immediate dilution in the recipient's blood stream, is a very different situation from ongoing use of medication in a patient, with steady state concentrations achieved over time. It is therefore highly unlikely that these effects are relevant for recipient safety.

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.

MSM and blood donation: shifting to individualized risk assessment.

Deferring donors at higher risk for transfusion transmissible infections is an important part of ensuring blood safety. The deferral for gay, bisexual, and other men who have sex with men (gbMSM) was implemented in the 1980s in many countries, since they were identified as a high-risk group for AIDS/HIV. With the introduction of increasingly sensitive HIV antibody testing, augmented by nucleic acid testing, the window period for HIV infection-when a donor may be infectious but have negative test results-has shrunk dramatically. In Canada, this has led to progressively shorter deferral periods for gbMSM, decreasing from a permanent deferral for sex with another male since 1977 to a 5-year, 12-month, and eventually 3-month deferral period. These time-based deferrals maintained safety; however, they are seen as stigmatizing by many and still result in the deferral of sexually active gbMSM. More recently, several countries have moved to a donor screening approach based on assessing sexual risk behaviors in all donors. This article outlines research supporting changes in policy, current eligibility screening policies in several countries, and preliminary results postimplementation of new eligibility policies in Canada in September 2022.

Barriers and enablers to and strategies for promoting domestic plasma donation throughout the world: Overarching protocol for three systematic reviews.

INTRODUCTION: The growing demand for plasma protein products has caused concern in many countries who largely rely on importing plasma products produced from plasma collected in the United States and Europe. Optimizing recruitment and retention of a diversity of plasma donors is therefore important for supporting national donation systems that can reliably meet the most critical needs of health services. This series of three systematic reviews aims to synthesize the known barriers and enablers to source plasma donation from the qualitative and survey-based literature and identify which strategies that have shown to be effective in promoting increased intention to, and actual donation of, source plasma. METHODS AND ANALYSIS: Primary studies involving source or convalescent plasma donation via plasmapheresis will be included. The search strategy will capture all potentially relevant studies to each of the three reviews, creating a database of plasma donation literature. Study designs will be subsequently identified in the screening process to facilitate analysis according to the unique inclusion criteria of each review (i.e., qualitative, survey, and experimental designs). The search will be conducted in the electronic databases SCOPUS, MEDLINE, EMBASE, PsycINFO, and CINAHL without date or language restrictions. Studies will be screened, and data will be extracted, in duplicate by two independent reviewers with disagreements resolved through consensus. Reviews 1 and 2 will draw on the Theoretical Domains Framework and Intersectionality, while Review 3 will be informed by Behaviour Change Intervention Ontologies. Directed content analysis and framework analysis (Review 1), and descriptive and inferential syntheses (Reviews 2 and 3), will be used, including meta-analyses if appropriate. DISCUSSION: This series of related reviews will serve to provide a foundation of what is known from the published literature about barriers and enablers to, and strategies for promoting, plasma donation worldwide.

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.

Changes in Bone Density in Carriers of BRCA1 and BRCA2 Pathogenic Variants After Salpingo-Oophorectomy.

OBJECTIVE: To evaluate the effect of risk-reducing salpingo-oophorectomy (RRSO) on change in bone mineral density (BMD) in women aged 34-50 years with pathogenic variants in BRCA1 or BRCA2 ( BRCA1 /2). METHODS: The PROSper (Prospective Research of Outcomes after Salpingo-oophorectomy) study is a prospective cohort of women aged 34-50 years with BRCA1 or two germline pathogenic variants that compares health outcomes after RRSO to a non-RRSO control group with ovarian conservation. Women aged 34-50 years, who were planning either RRSO or ovarian conservation, were enrolled for 3 years of follow-up. Spine and total hip BMD were measured by dual-energy X-ray absorptiometry (DXA) scans obtained at baseline before RRSO or at the time of enrollment for the non-RRSO group, and then at 1 and 3 years of study follow-up. Differences in BMD between the RRSO and non-RRSO groups, as well as the association between hormone use and BMD, were determined by using mixed effects multivariable linear regression models. RESULTS: Of 100 PROSper participants, 91 obtained DXA scans (RRSO group: 40; non-RRSO group: 51). Overall, total spine, and hip BMD decreased significantly from baseline to 12 months after RRSO (estimated percent change -3.78%, 95% CI -6.13% to -1.43% for total spine; -2.96%, 95% CI -4.79% to -1.14% for total hip) and at 36 months (estimated percent change -5.71%, 95% CI -8.64% to -2.77% for total spine; -5.19%, 95% CI -7.50% to -2.87% for total hip. In contrast, total spine and hip BMD were not significantly different from baseline for the non-RRSO group. The differences in mean percent change in BMD from baseline between the RRSO and non-RRSO groups were statistically significant at both 12 and 36 months for spine BMD (12-month difference -4.49%, 95% CI -7.67% to -1.31%; 36-month difference -7.06%, 95% CI -11.01% to -3.11%) and at 36 months for total hip BMD (12-month difference -1.83%, 95% CI -4.23% to 0.56%; 36-month difference -5.14%, 95% CI -8.11% to -2.16%). Across the study periods, hormone use was associated with significantly less bone loss at both the spine and hip within the RRSO group compared with no hormone use ( P <.001 at both 12 months and 36 months) but did not completely prevent bone loss (estimated percent change from baseline at 36 months -2.79%, 95% CI -5.08% to -0.51% for total spine BMD; -3.93%, 95% CI -7.27% to -0.59% for total hip BMD). CONCLUSION: Women with pathogenic variants in BRCA1 /2 who undergo RRSO before the age of 50 years have greater bone loss after surgery that is clinically significant when compared with those who retain their ovaries. Hormone use mitigates, but does not eliminate, bone loss after RRSO. These results suggest that women who undergo RRSO may benefit from routine screening for BMD changes to identify opportunities for prevention and treatment of bone loss. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT01948609.

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.

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.

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.

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.

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.

Safety and effectiveness of a novel home-use therapeutic ultrasound device for the treatment of vaginal dryness in postmenopausal women: a pilot study.

To evaluate safety and effectiveness of therapeutic ultrasound for treatment of postmenopausal vaginal dryness. In a pilot study, postmenopausal women with self-reported vaginal dryness were randomized (1:1) to double-blind ultrasound treatment (n = 21) or sham (n = 21) for 12 weeks. Primary effectiveness endpoint was change from baseline to week 12 in Vaginal Assessment Scale symptoms (dryness, soreness, irritation, dyspareunia). Secondary effectiveness endpoint was scoring of clinician-reported Vaginal Health Index (elasticity, fluid, pH, mucosa, moisture). After 12 weeks, participants received open-label ultrasound treatment to 1 year. Safety endpoint was treatment-emergent adverse events. In the modified intent-to-treat population, women showed (mean ± standard error) reduction in Vaginal Assessment Scale with ultrasound treatment versus sham (n = 15, −0.5 ± 0.2 vs n = 15, −0.4 ± 0.3; P = 0.9) and improved Vaginal Health Index (n = 9, 2.7 ± 0.9 vs n = 9, 0.6 ± 1.4; P = 0.3). In the per-protocol analysis population, ultrasound treatment (n = 9) versus sham (n = 8) significantly reduced symptoms score (−0.6 ± 0.3 vs −0.0 ± 0.4; P = 0.05) and significantly improved Vaginal Health Index (2.7 ± 0.9 vs −0.4 ± 1.2; P = 0.03). Improvement in effectiveness endpoints were seen at 1 year compared with baseline. There were no differences in treatment-emergent adverse events between ultrasound treatment versus sham and no serious adverse events. Home-use ultrasound was safe and effective for treating vaginal dryness after 12 weeks. Effectiveness was maintained to 1 year. Therapeutic ultrasound could offer a new, nonhormonal treatment option for postmenopausal women with vulvovaginal atrophy.

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.