Examining participant representation by sex, race, ethnicity and age in United States blood donation and blood transfusion clinical trials.

Significant inequities based on sex, race, ethnicity, and age exist among participants in clinical trials dedicated to investigating medical disease states. While general demographic data regarding blood donors and blood transfusion recipients have been studied extensively, the demographics of participants involved in blood donation and blood transfusion clinical trials are unknown. We performed a cross-sectional analysis of United States (U.S.) -based interventional blood donation and blood transfusion clinical trials registered with Clinicaltrials.gov to ascertain the composition of participants' sex, race, ethnicity, and age, as well as diagnostic conditions and geographic trial locations.Eligible trials were undertaken between July 2003 and August 2020. Thirty-eight of the one hundred and fifty-two blood donation and blood transfusion clinical trials met inclusion criteria (seven blood donation and thirty-one blood transfusion trials). While the participant dataset from trial reports were incomplete, 100 % of blood donation trials reported sex and age, 71.4 % reported race, and 42.3 % reported ethnicity. 96.8 % of blood transfusion trials reported sex, 51.6 % reported race, 38.7 % reported ethnicity, and 100 % reported age. Among 2720 participants enrolled in the seven blood donation trials, females were underrepresented (28.5 %) compared to U.S. Census data. Conversely, female (50.8 %) and male participants (49.2 %) were equally represented in blood transfusion trials (9255 participants). White participants were overrepresented in blood donation trials (73.4 %), while Hispanic or Latinos were underrepresented in both blood donation (7.7 %) and blood transfusion (8.2 %) trials compared to 2019 U.S.Census data. Only 8.3 % of blood transfusion clinical trials open to adults reported including older adults (i.e., ≥ 65yo). Despite mandatory reporting requirements and an already established framework, researchers frequently failed to report complete demographics of blood donation and blood transfusion clinical trial participants. Furthermore, various demographic groups were underrepresented in blood donation and/or blood transfusion clinical trials, including females, Hispanic or Latino individuals, and older adults. These findings demonstrate the need for implementation of strategies to ensure equitable representation of individuals in blood donation and transfusion clinical trials.

Female Representation in Clinical Practice Guideline Panels in 2 Major Cancer Organizations.

Over the last decade, the proportion of female panelists in NCCN CPGPs has doubled, with more than 50% of members of 60 CPGPs in 2020 being women. In ESMO, although there was an increase in female representation in a few CPGPs from 2010 to 2020, overall female representation remains low (<30%). By continuing to examine these trends, we can create awareness and work toward developing appropriate targeted interventions to improve gender disparities in the major organizations that create CPGs for cancer care.

Risk of thrombosis in women with cancer undergoing controlled ovarian hyperstimulation for fertility preservation.

PURPOSE: The study aims to evaluate the risk factors and incidence of thromboembolic events among adult women with cancer who underwent controlled ovarian hyperstimulation (COH) for fertility preservation. METHODS: Retrospective, descriptive cohort analysis of patient demographics, medical history, cancer type/treatment, laboratory values, thrombosis within 6 months of COH. RESULTS: 4 of 127 study participants experienced a venous thromboembolic event within 6 months of COH. The median time between oocyte aspiration and the event was 0.25 years (range = 0.10-0.50). The average age at time of event was 25.3 years (SD = 5.3). Three of four thrombotic patients had ovarian cancer, one had breast cancer. All had received surgery and chemotherapy for treatment. All underwent an antagonist cycle ovarian stimulation protocol - none developed ovarian hyperstimulation syndrome. The average anti-mullerian hormone level at the time of hyperstimulation in the thrombosis group was 1.6 (SD = 1.3), compared to 3.6 in the non-thrombosis group. The average max estradiol level reached during ovarian stimulation was 1281.3 (SD = 665.3) in the thrombosis group and 1839.1 (SD = 1513.9) in the non-thrombosis group. Thromboembolic events were not directly associated with mortality. CONCLUSIONS: Within this small descriptive study, the incidence of thromboembolic events in women with cancer undergoing COH for fertility preservation is high. Cancer may play a greater role than COH in thrombosis risk. Ovarian cancer patients who undergo ovarian stimulation may have an increased risk compared to other cancer types. These findings may inform future, prospective studies to determine the role of thromboprophylaxis.

Pilot Study Characterizing the Hematology-Oncology Fellow Job Search Process: Tools Used and Identification of Potential New Resources.

While the search for post-fellowship employment is an essential part of early career development, little is known about the tools and techniques fellows use during their job search and the specific challenges they face during the process. In this pilot survey study of hematology-oncology (HO) fellows at a large academic training program, the majority of 20 respondents (43% of all fellows) reported a plan to specialize in medical oncology, and most planned to practice in an academic setting. Fellows who had started the job search process reported using several tools/techniques including online job centers and email distribution lists, word of mouth, prior connections with other institutions, and their HO fellowship program leadership, and most reported that their current institution provided help for their job search in at least one way. Job search challenges included learning about available positions, lack of mentorship on the process, lack of sufficient time for the process, and lack of preparation for negotiation. Fellows suggested additional resources that could be helpful to future job searchers including access to information about prior HO fellowship graduates, training in negotiation and interviewing, and career development mentorship. We plan to use this information to expand our own Career Development program for fellows enacting many of these suggestions, and we encourage the use of this information as pilot data for the development of larger studies across other medical and surgical specialties.

In cancer-associated VTE, apixaban was noninferior to dalteparin for recurrence and did not increase major bleeding.

SOURCE CITATION: Agnelli G, Becattini C, Meyer G, et al. Apixaban for the treatment of venous thromboembolism associated with cancer. N Engl J Med. 2020;382:1599-607. 32223112.

Hemostatic prophylaxis and colonoscopy outcomes for patients with bleeding disorders: A retrospective cohort study and review of the literature.

INTRODUCTION: Hemostatic prophylaxis (HP) is recommended for patients with bleeding disorders (PWBD) before invasive procedures. However, evidence-based guidelines are needed to determine optimal HP strategies. AIM: To determine outcomes of HP for PWBD undergoing colonoscopy. METHODS: We undertook a retrospective cohort study of HP and outcomes of colonoscopy procedures performed between 9 November 1993 and 13 February 2018 for PWBD who received care in the Mayo Clinic Comprehensive Hemophilia Treatment Center. RESULTS: During the study period, 73 PWBD (58 with milder phenotypes: haemophilia, von Willebrand disease [subtypes 1 and 2; II, VII and XI deficiency]) underwent 141 procedures. Preprocedural HP was given to 61%, and interventions were performed in 47%. Of the 39% without preprocedural HP, postprocedural HP was given for 11%. One major (0.7%; 6 days postprocedure despite HP) and 10 minor (7%) bleeding complications occurred, which tended to be in patients with severe disease and/or after excision of larger polyps. There was no significant difference in the rate of bleeding complications with or without preprocedural HP (8.1% vs 5.5%, respectively; P = .74, Fisher's exact test). CONCLUSION: The low bleeding rates in our cohort suggest that preprocedure HP may be withheld for patients with mild bleeding disorders who undergo colonoscopy with a low likelihood of requiring an intervention or who require only low-risk intervention. This strategy may be best used in experienced centres, provided optimal local hemostasis measures are undertaken and postprocedural HP is rapidly available if high-risk intervention is required. Further studies are needed to determine optimal evidence-based HP strategies for PWBD undergoing colonoscopy.

WOMENtorship: The #WomenInMedicine perspective.

Mentorship is essential for career development, personal development, and job satisfaction for physicians in academic medicine. Women in academic medicine face unique challenges including significant gender disparities in positions of leadership as well as difficulty finding mentors. As leaders in academic medicine, we have collated several structured recommendations for physicians of both genders seeking to be better mentors to female trainees and early career physicians. We discuss each of these recommendations in detail including the following: acknowledging your own strengths and limitations as a mentor, addressing issues of work-life integration, helping your mentee set long-term career goals, and acting as a sponsor as well as a mentor. We hope these suggestions are helpful for current and aspiring mentors and provide a platform to improve career development for female physicians and reduce gender inequities in academic medicine.

Identification of Factors Associated with Hematology-Oncology Fellow Academic Success and Career Choice.

Factors affecting hematology-oncology trainees' academic success and career choices have not been well characterized. We performed a retrospective study of 57 hematology-oncology fellows trained at Mayo Clinic between 2008 and 2017 in an attempt to identify factors associated with success during fellowship and with career choice (academic versus private). Sex, age, residency quality, and letters of recommendation indicating a "top" applicant were not associated with hematology or oncology in-training examination (ITE) scores, research productivity (abstracts/publications during fellowship), or career choice (academic versus private). Fellows with higher United States Medical Licensing Examination (USMLE) scores were more likely to perform well on ITE, but examination scores did not predict academic productivity or academic versus private career choice. More academically productive fellows were more likely to choose academic careers. Both ITE scores and productivity were associated with receipt of national and/or institutional awards. Finally, fellows who were non-US citizens and/or international medical graduates (IMG) had higher academic productivity both pre-fellowship and during fellowship and as per the observations above were more likely to choose academic careers. In conclusion, predictors of superior knowledge differ from predictors of academic productivity/career choice, and it is important to take multiple factors into account when selecting candidates most likely to succeed during fellowship.

Romiplostim for the management of perioperative thrombocytopenia.

Thrombocytopenic patients requiring invasive surgery have few options to improve their platelet count preoperatively. This is a single-centre, retrospective review of thrombocytopenic patients receiving the thrombopoietin receptor agonist romiplostim perioperatively to allow for surgical interventions. Patient characteristics, romiplostim use, and surgical and safety outcomes (bleeding, thrombosis, transfusions) were collected and analysed. Forty-seven patients underwent 51 surgical procedures (ranging from total hip arthroplasty to open cardiac surgery) with romiplostim support. Thrombocytopenia aetiologies included immune thrombocytopenia, chronic liver disease, haematological malignancy, drug-related thrombocytopenia, and hereditary thrombocytopenia. Median (range) platelet counts improved, from 47 × 109 /l (9-120 × 109 /l) at romiplostim initiation to 164 × 109 /l (28-603 × 109 /l) at the time of surgery (P < 0·0001). A dose of 3 µg/kg per week for 2 doses increased the platelet count to >100 × 109 /l in 79% of patients within 14 days. In 96% of cases, surgery proceeded on schedule without delay or cancellation. Four patients had bleeding events unrelated to thrombocytopenia and 1 patient developed deep venous thrombosis. Six patients required red cell transfusion and 3 patients required platelet transfusion perioperatively. In conclusion, romiplostim was effective in increasing platelet counts to allow surgery to proceed safely and on schedule. Bleeding and thromboembolic events were within acceptable limits for this surgical population.

Rebleeding vs Thromboembolism After Hospitalization for Gastrointestinal Bleeding in Patients on Direct Oral Anticoagulants.

BACKGROUND & AIMS: Little is known about outcomes of patients hospitalized for gastrointestinal bleeding (GIB) while they are taking direct oral anticoagulants (DOAC). We aimed to determine the frequency at which patients resume DOAC therapy following hospitalization for GIB in a real-world setting, and the risks and benefits. METHODS: We conducted a retrospective analysis of medical claims data from the Truven Health Marketscan Commercial Claims and Encounters Database, from January 1, 2010, through December 31, 2014. We collected data on 1338 adults treated with DOACs and hospitalized for GIB (dabigatran, n = 679; rivaroxaban, n = 608, apixaban, n = 51). Patients who developed GIB within 1 year of DOAC initiation, and had a DOAC claim filled within 1 month of GIB, were included in the analysis. Postdischarge readmissions due to thromboembolism and recurrent GIB within 90 days were reviewed. We used proportional hazards to identify factors associated with thromboembolism and recurrent GIB. RESULTS: The median age of patients who did not resume DOAC therapy was older (79 vs 78 y for patients who did resume DOAC therapy; P = .0005). Higher proportions of patients who did not resume DOAC had heart failure (25% vs 20% who did resume DOAC therapy; P = .01), received blood (36% vs 24%; P < .0001), and required intensive care (18% vs 12%; P = .003). Restarting DOAC therapy within 30 days was not associated with thromboembolism within 90 days (hazard ratio [HR], 0.98; 95% CI, 0.37-2.21) or recurrent GIB (HR, 1.44; 95% CI 0.72-2.68). On multivariate regression, prior venous thromboembolism was associated with postdischarge thromboembolism (HR, 3.30; 95% CI, 1.29-7.38), and thienopyridine use was associated with recurrent GIB (HR, 3.12; 95% CI, 1.55-5.81). A higher proportion of patients who resumed treatment with rivaroxaban, compared with other DOACs, had recurrence of GIB (log rank, P = .04). CONCLUSIONS: In a retrospective analysis of medical claims data from adults treated with DOACs and hospitalized for GIB, we found that older patients who require blood and intensive care were less likely to restart treatment with DOACs after GIB. Resuming DOAC therapy was not associated with thromboembolism within 90 days or recurrence of GIB; a history of venous thromboembolism and thienopyridine use were associated with a risk of subsequent thromboembolism and GIB respectively.

Escaping the Siren Song-Transitioning to Part-Time Work.

In this narrative medicine essay, a hematologist redirects her long-embraced ideal career as an academic physician for a more balanced life and for the work she loves in a part-time position.

The impact of postpartum hemorrhage on hospital length of stay and inpatient mortality: a National Inpatient Sample-based analysis.

BACKGROUND: Postpartum hemorrhage is a major cause of maternal morbidity and mortality, but the association between postpartum hemorrhage and hospital length of stay has not been rigorously investigated. OBJECTIVE: We explored the impact of postpartum hemorrhage on hospital length of stay and inpatient mortality, as these outcomes have both clinical and economic significance. STUDY DESIGN: We performed a retrospective analysis using data from the National Inpatient Sample database during the 2012 through 2013 time period. Deliveries were classified as postpartum hemorrhage due to uterine atony, nonatonic postpartum hemorrhage, or not complicated by postpartum hemorrhage (nonpostpartum hemorrhage). Average length of stay and inpatient mortality rates were compared between groups. RESULTS: Over the study interval, postpartum hemorrhage occurred in 3% of deliveries. Among deliveries complicated by postpartum hemorrhage, 76.6% were attributed to uterine atony and 23.4% were nonatonic. Women with nonatonic postpartum hemorrhage had the highest average length of stay (3.67 days) followed by atonic postpartum hemorrhage (2.98 days) and nonpostpartum hemorrhage (2.63 days); P < .001, all comparisons. Inpatient mortality rate of nonatonic postpartum hemorrhage over the entire study period was 104 per 100,000 compared to 019 per 100,000 for atonic postpartum hemorrhage and 3 per 100,000 for nonpostpartum hemorrhage deliveries (P < .001). CONCLUSION: From 2012 through 2013, women with postpartum hemorrhage experienced significantly longer length of stay and higher inpatient mortality rates than women without postpartum hemorrhage, largely attributable to nonatonic causes of postpartum hemorrhage. As hospital length of stay and inpatient mortality are important outcomes from both clinical and societal perspectives, interventions to reduce morbidity and mortality related to postpartum hemorrhage may simultaneously facilitate delivery of more cost-effective care and improve both maternal and population health.

Sex-based disparities in venous thromboembolism outcomes: A National Inpatient Sample (NIS)-based analysis.

Venous thromboembolism (VTE) contributes to significant morbidity, mortality, and socioeconomic burden. There is a paucity of literature regarding sex-based sociodemographic differences in VTE presentation and short-term outcomes. We aimed to compare clinical outcomes between men and women hospitalized for VTE management. We performed a retrospective analysis using data from the National Inpatient Sample (NIS) database from 2012 to 2013. Inclusion criteria were age 18 years and older and a primary discharge diagnosis of VTE. Sociodemographic features and medical comorbidities were analyzed, as were hospital length of stay and in-hospital mortality rates. A total of 107,896 patients met the inclusion criteria; 53% were female. Median age was 65 years (interquartile range 51-77) and women were older than men (65 vs 62 years, p<0.001). There were significant differences between men and women with respect to race, primary insurance payer and medical comorbidities, and small differences with respect to VTE location. Female sex was associated with a small but significantly longer hospital length of stay (mean ratio 1.04, 95% CI 1.03-1.05, p<0.001) but no significant difference in in-hospital mortality (2.2% vs 2.1%, p=0.15). In a multivariate model, there was no significant difference between women and men with respect to hospital length of stay or in-hospital mortality. In conclusion, we used data from the NIS to study over 100,000 patients hospitalized for VTE, and identified several sex-based disparities in sociodemographic factors and location of VTE. However, in a multivariable analysis correcting for these factors, sex was not associated with significant differences in clinical outcomes.

Aminocaproic acid use in hospitalized patients with hematological malignancy: a case series.

The antifibrinolytic aminocaproic acid is widely used in surgical settings to prevent blood loss and decrease transfusion requirements, and small observational studies have suggested that aminocaproic acid may be useful in the setting of malignancy-related bleeding. At our institution, aminocaproic acid is sometimes prescribed to patients with hematological malignancy who experience refractory thrombocytopenia with or without bleeding. We performed a 5-year retrospective review of 54 adult patients with 13 types of hematological malignancy who received aminocaproic acid at our institution. Indications for use included 31 (57.4%) for refractory thrombocytopenia with bleeding, 16 (29.6%) for refractory thrombocytopenia without bleeding, and 7 (13%) for bleeding alone. Patients received both oral and intravenous formulations. Administered doses ranged broadly and median duration of use was 6 days. Three patients (5.7%) developed deep venous thrombosis but none of the thrombotic events were clearly related to administration of aminocaproic acid. We conclude that aminocaproic acid may be a relatively safe and cost-effective adjunct treatment in the setting of bleeding related to the diagnosis and treatment of hematological malignancy. Prospective trials as well as formalized protocols for the use of aminocaproic acid may be indicated. Copyright © 2015 John Wiley & Sons, Ltd.

Tranexamic acid for preventing postpartum blood loss after cesarean delivery: a systematic review and meta-analysis of randomized controlled trials.

INTRODUCTION: There are several published clinical trials of the use of tranexamic acid (TXA) in an obstetric setting, but no consensus on its use or guidelines for management. MATERIAL AND METHODS: The aim of this meta-analysis was to evaluate the effectiveness of TXA in reducing blood loss when given prior to cesarean delivery. We performed a systematic search in electronic databases. We included all randomized controlled trials comparing the use of TXA prior to cesarean delivery with controls (either placebo or no treatment). RESULTS: Nine trials with 2365 women were included in the analysis. Women who received TXA had significantly less postpartum blood loss, a lower drop in hemoglobin and a lower incidence of postpartum hemorrhage and severe postpartum hemorrhage compared with controls. Moreover, the number of women who needed additional uterotonic agents was significantly lower in the TXA group than in controls. The percentage of women who required blood transfusions at, or immediately after, cesareans was significantly lower in the intervention group than in the controls. There was no difference in the incidence of thromboembolic events in the two groups. CONCLUSIONS: Prophylactic TXA given before cesarean skin incision in women undergoing cesarean delivery, under spinal or epidural anesthesia, significantly decreases blood loss, including postpartum hemorrhage and severe postpartum hemorrhage, in addition to the standard prophylactic oxytocin given after delivery of the neonate. The effect of TXA on thromboembolic events and mortality as well as its use in high-risk women should be investigated further.

Romiplostim in the management of the thrombocytopenic surgical patient.

BACKGROUND: Thrombopoietin receptor agonists increase platelet (PLT) counts and are approved for the treatment of chronic immune thrombocytopenia (ITP). These agents may also be useful for the management of thrombocytopenia in patients requiring surgical procedures. STUDY DESIGN AND METHODS: We conducted a retrospective review of patients with thrombocytopenia (baseline PLT count, <150 × 10(9) /L) who received romiplostim before planned operative procedures. We characterized patient demographics, dosing and duration of romiplostim use, success in achieving PLT counts high enough for surgery, and clinical outcomes. RESULTS: Eighteen patients underwent a total of 22 operative procedures, including three Jehovah's Witnesses who underwent five procedures. Etiologies of thrombocytopenia included mild ITP (not on romiplostim at baseline), liver disease, hematologic malignancy, and drug-related thrombocytopenia. Median PLT count at romiplostim initiation was 47 × 10(9) /L (range, 11 × 10(9) -120 × 10(9) /L). All patients experienced a PLT count increase over a median of 4 weeks; median PLT count at surgery was 144 × 10(9) /L (range, 28 × 10(9) -370 × 10(9) /L). PLT counts increase to more than 150 × 10(9) /L in four of five Jehovah's Witness patients by the time of surgery. There were no surgical delays or cancellations due to thrombocytopenia. Four bleeding events occurred; none were fatal and none occurred at a PLT count of fewer than 80 × 10(9) /L. No definitive thromboembolic events occurred. CONCLUSION: Romiplostim successfully increased preoperative PLT counts allowing operative interventions, was well tolerated, did not lead to any significant thromboembolic events, and avoided the need for transfusion. Romiplostim may be of clinical utility in the preoperative management of thrombocytopenic patients, especially those unable to receive or unresponsive to PLT transfusion.