ABSTRACT
Introduction: Cerebral venous sinus thrombosis (CVST) is a rare but potentially debilitating thrombosis affecting 3-4 cases per million adults in the United States. Risk factors are thought similar to venous thrombosis, but there is little epidemiologic data corroborating this assertion. Concern about a possible association between the Janssen (Johnson and Johnson) and Oxford-AztraZenaca COVID-19 vaccines and cases of CVST resulted in increased global attention to this condition. Thus, large epidemiological assessment of the risk factors, treatment and outcomes of CVST are needed. Objective(s): Estimate the distributions of risk factors antecedent to CVST diagnosis, report CVST treatments in clinical practice, and potential sequelae of CVST in a large retrospective cohort of adults with CVST in the United States. Method(s): MarketScan Commercial and Medicare Supplemental administrative databases were employed to assess CVST diagnosed between 2011 and 2019 in the U.S. Validated International Classification of Disease (ICD) codes and receipt of an outpatient anticoagulant (either oral or subcutaneous anticoagulant) prescription within 30 days of the ICD code identified incident CVST. Antecedent clinical characteristics, treatments, and sequelae of CVST were identified using inpatient, outpatient, and prescription data. For outcomes, proportions and incidence with 95% confidence intervals (CIs) were calculated, stratified by sex. Result(s): We identified 1,869 CVST patients. Of these 1,314 (70%) were female, with 200 (10%) events identified as a pregnancy-related CVST. The average age was 41 years for females and 48 years for men. Among women, 24.7% were on hormonal therapy (oral contraceptive, estrogen, and progestin) prior to diagnosis. Men had a higher prevalence of comorbidities, such as diabetes (15% men vs. 9% women) and cancer (19% men vs. 10% women). Oral anticoagulant (OAC) use was the most common treatment for CVST in both men (88%) and women (85%) and did not vary by sex. Use of procedures to treat CVST, optic nerve fenestration and catheter directed thrombolysis, were 0.5% and 4.1%, respectively. The most common sequela after CVST was incidence of intracranial hypertension (Incidence: 4.2 per 100 person-years;95% CI: 3.3, 5.1) and palliedema was rare. Conclusion(s): Overall, a majority of CVST patients were women of reproductive age. Our findings suggest a potential association with both endogenous (pregnancy) and exogenous (oral contraceptives, HRT) hormones which needs further study. In our sample, CVST was managed with oral anticoagulants, regardless of sex, and intracranial hypertension was elevated following CVST. This large claims-based analysis is a descriptive insight into the risk factors and management of CVST, a rare and debilitating condition.
ABSTRACT
Background: To reduce the risk of hospital-acquired venous thrombosis (HA-VTE) in medical patients, guidelines recommend assessing HA-VTE risk and providing prophylaxis for those at high risk. Risk assessment models (RAMS) including objective risk factors available at admission remain an unmet clinical need. Aim(s): To develop and validate a RAM for HA-VTE in medical inpatients using data available to providers within 24-h of hospital admission. Method(s): We developed a HA-VTE RAM at the University of Vermont Medical Center (Burlington, Vermont, USA, Table 1) and validated this RAM at Michigan Medicine (Ann Arbor, Michigan, USA, Table 2). HA-VTE and the risk factors were identified using previously validated computable phenotypes. The RAM was developed using a Bayesian LASSO approach with model performance assessed using area under the receiver operating curves (AUC) and the slope of observed versus expected plot. People admitted with VTE were excluded. The research was approved by the Institutional Review Board funded by the National Institutes of Health and the Centers for Disease Control and Prevention, USA. Result(s): Table 1 presents the risk factors, odds ratios (OR) and 95% credible intervals (CI) for the HA-VTE RAM, which included 11 risk factors. For the development cohort, based on 219 events among 62,468 admissions, the AUC of the model was 0.75 and the observed versus expected slope was 1.11 (Table 2). In the validation cohort there were 48,265 admissions and 363 HA-VTE events with a younger population and a higher incidence of HA-VTE. The AUC and the observed versus expected slope were 0.69 and 0.89 (Table 2). Conclusion(s): We developed and validated a HA-VTE RAM in populations. The model fit and calibration are promising especially given these are two geographically diverse institutions. Further validation is in progress at additional hospitals as well as in people hospitalized with COVID-19.
ABSTRACT
Introduction: Our previous qualitative studies of immune-mediated thrombotic thrombocytopenic purpura (iTTP) survivors revealed that patients did not communicate to their hematologists about residual cognitive and fatigue issues. A way to overcome this communication barrier is implementation of patient-reported outcomes (PROs) in routine care. Integration of PROs into the clinical care of other diseases has resulted in improved patient-provider communication, symptom management, quality of life and overall patient satisfaction. However, decisions about the mode of administration are challenging. Although 92% of the United States population has access to the internet, studies have shown minorities prefer alternative modes of administration. Given that iTTP disproportionately affects Black women, understanding patient preference is critical for integrating PRO instruments into routine care. The primary study goal was to determine the preferred mode of administration of PRO instruments in iTTP. Furthermore, many individuals use the internet as a source of medical information/advice. A study of iTTP literacy reported that only 34% of survivors correctly identified disease relapse risk factors suggesting a critical knowledge gap. A secondary goal was to describe iTTP survivors' behaviors regarding using the internet for medical information or support. Methods: We utilized a cross-sectional study design. iTTP survivors were recruited from August 2019 until present. Eligibility included: 1) age >18 years, 2) documented ADAMTS13 deficiency (< 10% activity) at diagnosis or during a relapse and 3) > 1-year clinical remission. Multi-center recruitment of survivors included: Oklahoma University, Ohio State University, University of Minnesota, Johns Hopkins University, University of Rochester, University of Pennsylvania, University of Alabama at Birmingham, University of Utah and the University of Vermont. Following informed consent, survivors were administered the PROMIS ® cognitive function ability, anxiety and fatigue instruments via their preferred mode (online, telephone, or self-administered). Typical internet usage, behaviors regarding searching for health information online and demographics were also obtained. Results: To date, 94 survivors have completed the study (83% female;54% White;34% Black;median age 49 years [range 26-85 years]). A majority (54%) preferred completing PROMIS ® surveys online vs. self-administered or telephone administered. However, among Black survivors, only 38% preferred online administration and among survivors aged ≥65 years only 22% preferred online administration. Interestingly, there was an overall shift in a preference toward online administration following the onset of the COVID-19 pandemic (45% (21/47) preferred online pre vs 66% (31/47) preferred online post). Ninety-one percent (86/94) of survivors reported at least occasional internet use vs 8 (9%) reported none. Similarly, 82% (70/85) had searched the internet for health/medical information for themselves in the past year. Also 62% (53/86) of the survivors selected ‘strongly agree’ or ‘agree’ to the statement that the internet helps them determine if symptoms are important enough to see a doctor. Likewise, 62% used the internet to interpret doctor's recommendations. Additionally, 47% (40/86) ‘strongly agree/agree’ the internet helped determine if they would take a medication/seek alternative treatment. Moreover, 64% (55/86) agreed the internet was a good way to find others experiencing similar health problems. However, when asked about behaviors over the past year, only 42% (36/85) used online social networking sites like Facebook to look for health information or find others with iTTP and only 36% (31/85) had actually participated in online iTTP support groups. Conclusions: Overall iTTP survivors preferred online PRO administration;however, Black and older survivors preferred other methods. Recognizing these preferences is a vital step toward integrating PROs into routine care. Furthermore, iTTP survivors are us ng the internet as a source of medical support and information. Therefore, it is critical to not only educate iTTP survivors about credible online resources but also to create additional content. Also, future studies are needed to further explore the impact of the COVID-19 pandemic on online health behaviors. Disclosures: Terrell: Sanofi: Consultancy;Takeda: Consultancy. Journeycake: HEMA Biologics: Honoraria;LFB: Honoraria. Mazepa: Answering TTP Foundation: Research Funding;Sanofi Aventis: Other. Cuker: Spark Therapeutics: Research Funding;Sanofi: Research Funding;Pfizer: Research Funding;Takeda: Research Funding;Novo Nordisk: Research Funding;Novartis: Research Funding;Bayer: Research Funding;Alexion: Research Funding;UpToDate: Patents & Royalties;Synergy: Consultancy. Chaturvedi: Dova: Other: Advisory board member;UCB: Other: Advisory board participation;Argenx: Other: Advisory board member;Alexion: Other: Advisory board member;Sanofi Genzyme: Other: Advisory board member. Lim: Hema Biologics: Honoraria;Sanofi Genzyme: Honoraria;Dova Pharmaceuticals: Honoraria. Gangaraju: Alexion: Consultancy;Sanofi Genzyme: Consultancy. Cataland: Alexion: Consultancy, Research Funding;Sanofi Genzyme: Consultancy;Ablynx/Sanofi: Consultancy, Research Funding;Takeda: Consultancy.