scholarly journals Hematocrit Self-Testing in Patients with Polycythemia Vera: A Proof-of-Concept Study Assessing the Accuracy of the Statstrip Xpress ® 2 Hb/Hct Device and Its Impact on Patients' Quality of Life in Clinical Practice

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1935-1935
Author(s):  
Alicia Rovo ◽  
Claudia Baierlein-Leimbach ◽  
Cesare Medri ◽  
Ioannis Chanias ◽  
Loreen Errass ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Blood Cell ◽  
Financial Support ◽  
Research Funding ◽  
The Self ◽  
Cell Counts ◽  
Self Testing ◽  
Data Points ◽  
Self Test ◽  
At Home

Abstract Introduction: Patients with polycythemia vera (PV) have an increased risk of morbidity and mortality from thromboembolic events and cardiovascular disease, particularly for hematocrit (Hct) levels > 45% (Marchioli et al., 2013). Maintaining Hct < 45% is therefore important to reduce these risks. A device that patients can use to frequently monitor their own Hct levels could provide a detailed picture of the change in Hct over time, enable timely clinical visits and disease management, reduce disease burden, and increase patients' quality of life (QoL). A meter to measure hemoglobin (Hb) and Hct that has been approved for medical professional use (StatStrip Xpress ® 2 Hb/Hct meter, Nova Biomedical Corporation) has potential as an at-home, self-testing device. Purpose: To carry out a proof-of-concept study in clinical practice to test the accuracy of the StatStrip Xpress 2 Hb/Hct meter, to evaluate its feasibility for patient self-testing, and to assess its impact on patient-reported outcomes. Methods: Adults (aged > 18 years) who had PV (according to the World Health Organization 2016 criteria), or conditions with Hct < 35% or Hct > 50%, who required monitoring of Hct/Hb values in clinical practice and who provided informed consent were enrolled from two Swiss centers in this observational study. During each routine visit, patients collected and analyzed a finger-prick blood sample using StatStrip Xpress 2 Hb/Hct (self-test) without guidance or intervention from healthcare professionals (HCPs); HCPs then repeated this test (professional test). At each visit, HCPs also collected and analyzed a venous blood sample using a laboratory hematology analyzer (Sysmex), and patients completed a 15-minute questionnaire about use of the self-test device. The primary endpoint was mean difference in absolute percentage points between Hct values from the professional test and the analyzer (mdiff, 90% confidence interval [CI]; Spearman correlation [r]). Secondary endpoints included mdiff for Hct (%) and Hb (g/dl) between values obtained from the self-test and professional test, and the self-test and analyzer. Other endpoints included the correlation between the professional test Hct values and other blood cell counts. The study was approved by local ethics committees. Results: Blood measurements from 68 visits for 60 patients (PV = 32; other conditions with Hct < 35% or > 50% = 28) were included in the analysis. For the primary endpoint, Hct values were very similar for the analyzer and professional test (66 data points after removal of 1 outlier; mdiff = 0.1% [CI: ‒0.5-0.8]; r = 0.95, p < 0.001). Importantly, Hct results were also similar for the self-test and professional test (63 data points after removal of 2 outliers; mdiff = -0.2% [CI: ‒0.98-0.5]; r = 0.93, p < 0.001) and the analyzer and self-test (64 data points after removal of 2 outliers; mdiff = 0.1% [CI: ‒0.6-0.8]; r = 0.93, p < 0.001). Similar results were obtained for Hb measurements across the tests. There was no correlation between the accuracy of Hct values from the professional test (vs the analyzer) and blood cell counts, but this should be interpreted with caution because there was a limited number of patients with extreme white blood cell and platelet counts. There was no influence of sex (male/female), age (≤ 75 years/> 75 years) or, in the case of patients with PV, time from diagnosis on the results. Responses to the patient questionnaire showed that 92% of patients were satisfied or very satisfied with the self-test device, 100% found it easy to use, and 97% were willing to start using it at home. Of patients with PV, 71% stated that using a self-testing device would make them feel safer and 56% felt that it would have a positive effect on their QoL. Conclusions: This study demonstrates the accuracy of the StatStrip Xpress 2 Hct/Hb meter vs a laboratory analyzer for measuring Hct and Hb levels. Importantly, it shows that measurements taken by patients are as accurate as those taken by HCPs. These findings highlight the potential benefits of introducing an instrument for at-home self-testing to the management of patients with PV or other hematological conditions that require regular Hct/Hb monitoring. Benefits to patients may include increased QoL, improved clinical outcomes, and reduced morbidity and mortality through timely clinical action. In addition, fewer outpatient appointments may mean reduced healthcare costs. Figure 1 Figure 1. Disclosures Rovo: Novartis: Honoraria; BMS: Honoraria; Amgen: Other: Financial support for congresses and conference travel; AstraZeneca: Other; Swedish Orphan Biovitrum AG: Honoraria; AG Alexion: Honoraria; OrPhaSwiss GmbH: Honoraria; AstraZeneca: Honoraria; BMS: Other; Sanofi: Other; Roche: Other; Novartis: Research Funding; CSL Behring: Research Funding; AG Alexion: Research Funding. Baierlein-Leimbach: Novartis Pharma Schweiz AG: Current Employment. Triemer: Novartis Pharma Schweiz AG: Current Employment. McCarthy-Pontier: Novartis Pharma Schweiz AG: Current Employment. Lehmann: AbbVie: Honoraria; Novartis: Research Funding; Janssen: Honoraria; Swedish Orphan Biovitrum AG: Honoraria; Janssen: Other; Roche: Other; Abbvie: Other: Financial support for congress and conference travel ; Amgen: Other: Financial support for congress and conference travel ; Celgene: Research Funding; Incyte: Honoraria; BMS: Honoraria; Amgen: Honoraria.

scholarly journals Feasibility of large-scale population testing for SARS-CoV-2 detection by self-testing at home

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Paula Iruzubieta ◽  
Tatiana Fernández-Lanas ◽  
Laura Rasines ◽  
Lorena Cayon ◽  
Ana Álvarez-Cancelo ◽  
...  
Keyword(s):  
Large Scale ◽  
Rapid Test ◽  
The Self ◽  
Healthcare Personnel ◽  
Testing Strategy ◽  
Self Testing ◽  
Scale Population ◽  
Self Test ◽  
Test Result ◽  
At Home

AbstractThe simplicity and low cost of rapid point-of-care tests greatly facilitate large-scale population testing, which can contribute to controlling the spread of the COVID-19 virus. We evaluated the applicability of a self-testing strategy for SARS-CoV2 in a population-based, cross-sectional study in Cantabria, Spain, between April and May 2020. For the self-testing strategy, participants received the necessary material for the self-collection of blood and performance of a rapid antibody test using lateral flow immunoassay at home without the supervision of healthcare personnel. A total of 1,022 participants were enrolled. Most participants correctly performed the COVID-19 self-test the first time (91.3% [95% CI 89.4–92.9]). Only a minority of the participants (0.7%) needed the help of healthcare personnel, while 6.9% required a second kit delivery, for a total valid test result in 96.9% of the participants. Incorrect use of the self-test was not associated with the educational level, age over 65, or housing area. Prevalence of IgG antibodies against SARS-CoV2 for subjects with a valid rapid test result was 3.1% (95% CI 2.2–4.4), similar to the seroprevalence result obtained using a conventional approach carried out by healthcare professionals. In conclusion, COVID-19 self-testing should be considered as a screening tool.

Machine Learning for Prediction of Cancer-Associated Venous Thromboembolism

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 37-37
Author(s):  
Simon Mantha ◽  
Andrew Dunbar ◽  
Kelly L. Bolton ◽  
Sean Devlin ◽  
Dmitriy Gorenshteyn ◽  
...  
Keyword(s):  
Machine Learning ◽  
Blood Cell ◽  
Cell Count ◽  
Cancer Diagnosis ◽  
Research Funding ◽  
Cross Validation ◽  
Genetic Data ◽  
Cancer Type ◽  
Cell Counts ◽  
Predicted Risk

Background: Several clinical prediction scores have been designed to assess the risk of cancer-associated thrombosis (CAT). The most commonly used in current clinical practice is the Khorana score, however it is applicable only to patients prior to initiation of chemotherapy. We now apply machine learning with clinical, demographic, and genomics parameters to predict CAT events. Methods: The random survival forest (RSF) ensemble learning method was selected to illustrate a machine approach to CAT prediction. The cohort consisted of 14,223 individuals with a solid tumor malignancy and MSK IMPACT somatic genomic data collected during the years 2014 to 2016. CAT was defined as the diagnosis of lower extremity deep vein thrombosis (proximal or distal) or pulmonary embolism, incidental or symptomatic. Covariates considered for inclusion in the model consisted of tumor type, metastatic status, age, exposure to cytotoxic chemotherapy in the month before cohort entry, time elapsed since cancer diagnosis, time elapsed since tumor sampling, normalized mean blood cell counts (white cell count, hemoglobin, platelet count) in the prior 3 months, normalized mean prothrombin time (PT) and activated partial thromboplastin time (aPTT) in the prior 3 months, body mass index (BMI), and presence or absence of a somatic genetic alteration for oncogenes/tumor suppressor genes with an alteration frequency ≥ 1.5% (n = 56). The primary endpoint consisted of time to CAT episode. The C-index for models including different covariates was derived from the test holdout sample using repeated 10-fold cross-validation. The C-index, measuring the relative agreement between the RSF predicted risk and the CAT times of patients, has values between 0.5 and 1.0 with the latter indicating perfect agreement. Results: 12,040 patients were included in the final analysis. There were 855 CAT events during the observation period. The most common tumor types were lung (17%), breast (15%) and colorectal cancer (9%). Blood cell count data and coagulation parameters were missing for 8% and 51% of patients respectively. Using cross-validation, the baseline model with cancer type and metastatic status had a C-index of 0.62 (95% CI = 0.61-0.64), which increased to 0.65 (95% CI = 0.63-0.66) with the addition of chemotherapy, age, time from tissue sampling, time from cancer diagnosis and BMI. Further adding genetic data increased the C-index to 0.68 (95% CI = 0.66-0.69). Replacing genetic data in this model with cell counts and coagulation parameters resulted in a C-index of 0.69 (95% CI = 0.68-0.70). The model with all available covariates had a C-index of 0.70 (95% CI = 0.69-0.71). The cumulative incidence of CAT at 6 months for 5 categories of predicted risk using the model with all available covariates is plotted in Figure A. Scaled Ishwaran-Kogalur Variable Importance (VIMP) values, presented in Figure B, indicate that cancer type and prior chemotherapy are the two top factors for model performance. Conclusions: Machine learning is a promising approach in the search of more accurate and generalizable models for prediction of CAT. In the application described here, the use of random survival forests performed well without information about future chemotherapy administration. Additional work is needed to identify the optimal algorithm and covariates, including better delineation of which cancer genomic information should be retained. Future models will have to be validated independently before being used for patient care. Disclosures Mantha: Physicians Education Resource: Honoraria; MJH Associates: Honoraria. Bolton:GRAIL: Research Funding. Soff:Bristol-Myers Squibb, Pfizer: Honoraria; Dova Pharmaceuticals: Honoraria; Janssen Scientific Affairs: Honoraria; Amgen: Research Funding; Janssen Scientific Affairs: Research Funding; Amgen: Honoraria; Dova Pharmaceuticals: Research Funding.

Targeting EVI1-Overexpressing AML with Darinaparsin

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4269-4269
Author(s):  
Koren K Mann ◽  
Nathalie Johnson ◽  
Torsten Holm Nielsen ◽  
Nicolas Garnier ◽  
Stanley Kwan ◽  
...  
Keyword(s):  
Blood Cell ◽  
Mrna Expression ◽  
Arsenic Trioxide ◽  
White Blood Cell ◽  
Transcriptional Repression ◽  
Research Funding ◽  
Cell Counts ◽  
Blood Cell Counts ◽  
Pten Mrna ◽  
White Blood Cell Counts

Abstract Abstract 4269 Ecotropic viral integration site 1 (EVI1) is a critical oncogene driving a subset of myeloid malignancies and overexpression of EVI1 predicts an extremely poor prognosis in both adult and pediatric AML patient populations. Activation of EVI1, due to chromosomal translocation, inversion or transcriptional upregulation, occurs in 8–10% of AML and results in both activation and repression of specific gene sets. Importantly, the tumor suppressor PTEN is repressed by EVI1. Arsenic trioxide targets EVI1 for degradation, suggesting that arsenicals may be effective in treating EVI1-positive malignancies. Indeed, MDS patients with EVI1 deregulation had greater benefit from the combination of arsenic trioxide (inorganic arsenic) and thalidomide than patients without EVI1 deregulation. Here, we describe the use of a novel arsenical, darinaparsin (an organic form of arsenic), to treat a patient with EVI1-overexpressing AML, as a 10th line of chemotherapy. A 36 year old woman was diagnosed with AML inv(3)(q21q26.2) where two copies of inv(3) were detected. Her initial treatment included two induction regimens followed by an allogeneic stem cell transplant. She had complete remission lasting 5 years after which time her AML relapsed. Three high dose regimens, including VP16 (4g) and cyclophosphamide (2.7g), failed to induce another remission (>80% blasts in the bone marrow). She was offered an investigational combination therapy of ribavirin and low dose cytarabine but after one month, her peripheral blast count rose to >60 and was not responding to hydrea (8g) or mitoxantrone (20mg). At this time, we compared the anti-tumor activity of arsenic trioxide and darinaparsin on the patient’s peripheral blasts in vitro and found that darinaparsin induced significantly more cell death than arsenic trioxide. Thus, the patient started darinaparsin (300 mg/m2 IV over 60 minutes for 5 days every 21 days). Within 10 hours of receiving her first dose, her fever and night sweats had resolved. She regained her energy and appetite and was discharged home 2 days after her last dose. Unlike previous drug regimens, darinaparsin allowed the patient to enjoy a good quality of life for more than 30 days with an ECOG performance status of 1. Unfortunately, while darinaparsin stabilized her peripheral white blood cell counts, the patient died of extramedullary manifestations and complications of her AML, 36 days after receiving the first dose of darinaparsin. Darinaparsin decreased her peripheral white blood cell counts during the five days of treatment, which was followed by an additional decrease in the white blood cell count when serum arsenic levels were low to undetectable. We observed visible nuclear and cytoplasmic blebbing consistent with cells undergoing apoptosis. Although EVI1 protein levels were difficult to measure consistently, we analyzed the transcriptional repression activity of EVI1 by measuring PTEN mRNA expression. Intriguingly, we found a significant increase in PTEN mRNA in leukemic blasts following each course of darinaparsin, supporting the hypothesis that darinaparsin may target EVI1 or its activity. We utilized cDNA microarray expression profiling and found that gene expression of her tumor changed dramatically between the first and second cycle, including a significant increase in the pro-survival NF-κB pathway. NF-κB family member (i.e. NFKB1, 2, IA, IB, IE, RELA, TANK, TRAF1 and TRAF2) mRNA expression increased 2–8 fold following the first cycle of darinaparsin. Based on these data, we conclude that darinaparsin should be further explored as a treatment for EVI1-overexpressing myeloid malignancies using the transcriptional repression activity of EVI1 by measuring PTEN mRNA expression as a biomarker for identification of patients likely to respond to therapy. Disclosures: Mann: ZIOPHARM Oncology Inc: Research Funding. Morgan:ZIOPHARM Oncology Inc: Employment. Miller:ZIOPHARM Oncology Inc: Research Funding.

scholarly journals Eltrombopag Improves Hematopoiesis in Patients with Low to Intermediate-2 Risk Myelodysplastic Syndrome (MDS)

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 229-229 ◽  
Author(s):  
Alana Vicente ◽  
Fernanda Gutierrez-Rodrigues ◽  
Valentina Giudice ◽  
Zhijie Wu ◽  
Sachiko Kajigaya ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Blood Cell ◽  
Primary Endpoint ◽  
Peripheral Blood ◽  
Health Research ◽  
Research Funding ◽  
Peripheral Blood Cell ◽  
Cell Counts ◽  
Blood Cell Counts ◽  
Robust Response

Abstract Eltrombopag (EPAG), a thrombopoietin receptor agonist, has been shown to improve hematopoiesis in patients with aplastic anemia (AA), but in MDS patients the effect of thrombopoietin mimetics in bone marrow function is still unclear. In this phase-2 dose escalation study, we investigated the safety and effectiveness of EPAG treatment in low to intermediate-2 risk MDS patients (NCT 00961064). Thirty patients were enrolled from March 2011 to July 2017. Preceding enrollment the majority of patients were either diagnosed with AA (n=13) or hypoplastic MDS (n=5). EPAG was started at 50 mg/day, up to a maximal dose of 150 mg/day, increasing the dose by 25mg every 2 weeks. The primary endpoint was hematologic response at 16 or 20 weeks, defined as either: (1) an increase in platelet counts ≥20.000/uL or transfusion independence for a minimum of 8 weeks; (2) hemoglobin (Hb) increase of ≥1.5g/dL from baseline, or a reduction in red blood cells (RBC) transfusion of at least 50%; or (3) an increase in absolute neutrophil counts (ANC) of ≥0.5x109/L or by at least 100% in patients with a baseline ANC <0.5x109/L. Responding patients could continue EPAG treatment on an extension arm. The primary endpoint of hematological response was met in 14/30 patients (47%). All responders continued EPAG on the extension arm. In 3 patients, peripheral blood cell counts declined on EPAG after the initial response. One patient withdrew from the study. Ten of the 14 responding patients achieved a robust response (RR) after a median treatment duration of 15 months (range 7-27 months). Robust response was defined as stable hematopoiesis with at least a hemoglobin >10g/dl, and thrombocytes >50.000/L, and ANC>1000/L. However, peripheral blood cell counts significantly declined in 5/10 RR and EPAG was restarted per protocol. In 4 of these patients peripheral blood cell counts recovered. One patient did not achieve a second response. Based on International Prognostic Score System (IPSS), 4/30 (13%) patients progressed on study, including 3 non-responders and 1 responder, at a median follow-up of 4 months (3-35 months). The responding patient was diagnosed with increased bone marrow myeloblast 7 months after discontinuation of EPAG for robust response and 35 months after enrolling in the study. New cytogenetic abnormalities determined progression in non-responding patients (Figure). Novel dose limiting toxicities were not observed. Three patients developed CTCAE grade III hepatic toxicities. One of them discontinued EPAG at 3 months. Elevated transaminases returned to baseline after EPAG discontinuation in 2 patients. In both cases EPAG was resumed either at the same (150mg/day) or reduced dose (50mg/day) level. There were no treatment-related death cases. One patient died on study before the primary endpoint from acute respiratory distress syndrome. Sequential acquisition of genomic aberrations has been associated with malignant transformation. Targeting next-generation sequencing for somatic variants in genes previously associated with myeloid malignancies (Myeloid cancer genes, MCG) was performed in 29/30 patients with sufficient material (bone marrow mononuclear cells) available from baseline, primary endpoint, and at time of progression. At baseline, 22/29 (76%) patients were found with at least one mutation:TET2 (14.5%), ASXL1 (12.5%), SF3B1 (8.3%), SETBP1 (8.3%), ATM (8.3%), and ZRSR2 (8.3%). After EPAG, additional somatic variants in different genes were detected in 4/14 responders and 7/16 non-responders. Variants present at baseline were no longer detected in post EPAG samples from 4 responding and 6 non-responding patients. The VAF of variants detected at both time points were similar, indicating no selective expansion of clones with EPAG in neither responder, non-responder nor patients with progression based on IPSS. In conclusion, our results suggest that EPAG is well-tolerated and effective in restoring hematopoiesis in patients with low to intermediate-2 risk MDS, particular with a prior history of hypoplastic bone marrow failure syndromes. EPAG was discontinued for robust response in the majority of responders but declining blood cell counts were observed in about 50% of them. Variants in MCG were more common at study entry compared to patients with aplastic anemia (Yoshizato, NEJM, 2015). However, EPAG appears not to selectively promote expansion of clones harboring MCGs in this patient population. Disclosures Townsley: National Institute of Health: Research Funding. Scheinberg:Pfizer: Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Janssen: Honoraria, Research Funding. Dunbar:National Institute of Health: Research Funding. Young:GlaxoSmithKline: Research Funding; CRADA with Novartis: Research Funding; National Institute of Health: Research Funding. Winkler:National Institute of Health: Research Funding.

scholarly journals Can an HIVSmart! App-optimized Self-Testing Strategy be Operationalized in Canada?

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S426-S426
Author(s):  
Nitika Pant Pai ◽  
Megan Smallwood ◽  
Laurence Desjardins ◽  
Alexandre Goyette ◽  
Anne-Fanny Vassal ◽  
...  
Keyword(s):  
Testing Procedure ◽  
The Self ◽  
Health Clinic ◽  
Test Results ◽  
Testing Strategy ◽  
Self Testing ◽  
Hiv Test ◽  
Post Test ◽  
Self Test ◽  
Sex With Men

Abstract Background Although HIV self-tests are recommended by the WHO, they are not yet approved in Canada. Service delivery gaps such as linkages to counseling and care remain unachieved by offering self-tests without adequate support. In this first Canadian study, we evaluated the feasibility of operationalizing an innovative HIVSmart! app-optimized oral HIV self-testing strategy in men who have sex with men (MSM), presenting at a large sexual health clinic in Montreal. Methods Between July 2016 to February 2017, participants were offered the OraQuick In-Home HIV Test, and a tablet installed with the HIVSmart! app, at a private office in the clinic to simulate an unsupervised home environment. With the HIVSmart! app, participants independently performed and interpreted self-tests, and were linked to in-person post-test counseling and care. Self-test results were confirmed by laboratory tests (p24, Western Blot, RNA as needed). Results The mean age of the 451 participants was 34 years (18–73); 85% were well educated (beyond high school, n = 371/438); 53% (230/438) were frequent testers (past 6 months), and 13% were on PrEP (52/451). 99% (417/422) of participants found the HIVSmart! app helpful in guiding them through the self-testing procedure; 93% (418/451) of participants interpreted their tests accurately; and 94% (395/419) stated they would recommend the app-optimized self-testing strategy to their partners. Feasibility (completion rate of self-testing) was 93% (419/451), and acceptability of the strategy was high at 99% (451/458). All HIV self-test negative participants (448/451, 100%) were counseled following the self-test. Three participants self-tested positive, were confirmed HIV positive (0.7% prevalence), and were rapidly linked to care with a physician. Conclusion The HIVSmart! app-optimized strategy was feasible, and highly accepted by an educated, frequently testing, urban MSM population of Montréal. With the app, participants were able to interpret their test results accurately and were rapidly linked to care. Innovations like HIVSmart! which engage, aid, and facilitate linkages to care, can be adapted to suit the needs of many populations in Canada and internationally, maximizing global impact through reverse innovation. Disclosures All authors: No reported disclosures.

scholarly journals LB11. Preliminary Findings from a HIV Self-Testing Program among People Who Use Drugs

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S810-S811
Author(s):  
Michelle Rose ◽  
Laura Guy ◽  
Steve Shamblen ◽  
Greg Guest ◽  
Adam Gilbertson ◽  
...  
Keyword(s):  
High Risk ◽  
Hiv Testing ◽  
Hiv Infections ◽  
Health Department ◽  
The Self ◽  
People Who Use Drugs ◽  
Research Support ◽  
Testing Program ◽  
Self Testing ◽  
Self Test

Abstract Background People who use drugs (PWUD) remain at significantly high risk for HIV infection. It is estimated that the majority of all new HIV infections are through injection drug use, with an estimated 2,500 new infections occurring annually among people who inject drugs. Although new HIV infections have been quickly rising over the past year, the Center for Disease Control and Prevention (CDC) preliminarily reported a 50% to 70% intra-pandemic decline in HIV testing. Within Kentucky, an ultra-high-risk state, multiple health departments reported all HIV testing stopped during the early stages of the COVID-19 pandemic (March-July 2020). Once testing resumed, appointments were sparse. Methods To address low rates of HIV testing among PWUD, we evaluated the acceptability of a HIV self-testing program (OraQuick In-Home HIV Test by OraSure Technologies, Inc.) implemented at a health department in Louisville, Kentucky that services PWUD. Descriptive statistics were calculated for testing location, testing self-efficacy, reasons and motivations, ease of use, and preferences for future services. Results From May to June 2021, a total of 230 PWUD engaged with the program (average of 18 per day). Most participants (87.8%) self-tested at the health department with the help of study staff, while the other 12.2% tested at home and returned at a later time. Approximately 77% of participants reported the self-test kit made them feel better able to keep track of their HIV status compared to standard testing methods. The most common reasons for testing were wanting to know their status (85%), the test was free (37%), fast results (31%), more privacy (23%), and recent high-risk drug use and sexual behaviors (17%). Virtually all (97%) reported the test kits were very easy to use. For future availability of self-test kits through the health department, 33% reported they would use them monthly, 28% every three months, 22% every six months, and 17% annually. In terms of preference for future testing modality, 72% indicated a preference for taking the kits home, while the other 28% indicated a desire to test at the health department with help from staff. Conclusion Program participants found the self-test kits to be acceptable and easy to use. Implications for program implementation and future research will be discussed. Disclosures Michelle Rose, MBA, Gilead Sciences Inc. (Grant/Research Support) Laura Guy, BS, CCRC, GILEAD Sciences (Grant/Research Support, Research Grant or Support)

Successful Treatment of a Diamond-Blackfan Anemia (DBA) Patient with Eltrombopag

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2682-2682 ◽  
Author(s):  
Thomas Winkler ◽  
Danielle Townsley ◽  
Ronan Desmond ◽  
Bogdan Dumitriu ◽  
Sophia Grasmeder ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Blood Cell ◽  
Clinical Research ◽  
Research Funding ◽  
Bone Marrow Failure ◽  
Definitive Treatment ◽  
Splice Donor Site ◽  
Cell Counts ◽  
Blood Cell Counts ◽  
50Mg Daily

Abstract DBA is a rare bone marrow failure syndrome clinically defined by onset of hypoproliferative anemia in early childhood accompanied by a grossly normocellular bone marrow. With age, a significant fraction of patients progress to pancytopenia and a hypocellular bone marrow, with some increased risk of progression to leukemia. Autosomal dominant or sporadic heterozygous mutations in genes encoding for ribosomal subunit proteins have been etiologically linked to DBA. How loss of function mutations in ribosomal proteins results in selective loss of erythroid progenitors with variable severity is incompletely understood. Chronic transfusion therapy and corticosteroid treatment can alleviate anemia, but both cause severe long term toxicities. Hematopoietic stem cell transplantation, when available, is the only definitive treatment modality for the hematological manifestations, and the only known treatment for DBA patients once pancytopenia develops. Here we report on a 28 year old female patient diagnosed with DBA at age of one month based on clinical criteria. Recent mutational analysis identified a novel mutation in intron 4(c.356+3>C) of the RPS19 gene affecting a known splice donor site that has previously reported in DBA patients. She did not respond to corticosteroids and was maintained on transfusions. She failed various experimental therapies including danazol, hematopoietic growth factors including IL-3 and GM-CSF, and anti-thymocyte globulin/cyclosporine without sustained clinical response. After treatment with daclizumab in 2006 her transfusion requirements decreased for about 4 years. In 2012 she presented with progressive pancytopenia and hypocellular bone marrow without overt dysplasia, and normal cytogenetic analysis. She required red cell transfusions. The patient was enrolled in a clinical research protocol investigating the efficiency and safety of the thrombopoietin receptor agonist eltrombopag (EPAG) in patients with moderate aplastic anemia or those with bone marrow failure with unilineage cytopenia (ClinicalTrials.gov: NCT01328587). The study is designed as a non-randomized, phase II, dose modification study with the primary endpoint hematological response at 16 weeks. EPAG was administered at 50mg daily and escalated every 2 weeks by 25 mg to the maximal dose of 300mg daily. At response assessment the patient's hemoglobin (Hgb) improved from 7.0g/dl to 8.9g/dl and platelets from 112K/ul to 171k/ul. She required no further transfusions, and was deemed a responder. EPAG was subsequently continued at the same dose level for an additional 6 months when the peripheral cells counts peaked at Hgb 11.9g/dl, platelets 251K/ul, ANC 3.19 K/ul, and EPAG was discontinued for protocol-defined robust response. After discontinuation of EPAG the patient's hemoglobin steadily declined over a period of 8 months. EPAG was reinitiated at 300mg per protocol. Peripheral blood cell counts rapidly improved and the EPAG dose was slowly tapered. The patient is currently on EPAG 50mg daily with normal blood cell counts. We have not observed any EPAG related toxicities in our patient, and repeated cytogenetic studies on bone marrow documented a normal karyotype. To the best of our knowledge this is the first report documenting EPAG efficacy in a DBA patient. Trautman et al. (2012) previously reported a DBA patient that failed treatment with low dose EPAG after six months. Our observation warrants further systematic investigation of EPAG treatment for DBA patients within a clinical research study setting. Figure Figure. Disclosures Winkler: GSK/Novartis: Research Funding. Townsley:Novartis: Research Funding. Desmond:Novartis: Honoraria. Dumitriu:GSK/Novartis: Research Funding. Grasmeder:GSK/Novartis: Research Funding. Young:GSK/Novartis: Research Funding. Dunbar:GSK/Novartis: Research Funding.

scholarly journals Key Stakeholders’ Perspectives on Implementation and Scale up of HIV Self-Testing in Rwanda

Diagnostics ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. 194 ◽  
Author(s):  
Tafadzwa Dzinamarira ◽  
Collins Kamanzi ◽  
Tivani Phosa Mashamba-Thompson
Keyword(s):  
Underserved Populations ◽  
Scale Up ◽  
Implementation Process ◽  
The Self ◽  
Sub Saharan Africa ◽  
World Health ◽  
Successful Implementation ◽  
Key Stakeholders ◽  
Self Testing ◽  
Self Test

Introduction: The World Health Organisation recommends HIV self-testing as an alternative testing method to help reach underserved populations, such as men in sub-Saharan Africa. Successful implementation and scale-up of HIV self-testing (HIVST) in Rwanda relies heavily on relevant stakeholders’ involvement. We sought to explore HIVST key stakeholders’ perceptions of the implementation and scale-up of HIVST in Rwanda. Method: We conducted in-depth interviews with personnel involved in HIV response projects in Rwanda between September and November 2019. We purposively sampled and interviewed 13 national-level key stakeholders from the Ministry of Health, Rwanda Biomedical Center, non-governmental organizations and HIV clinics at tertiary health facilities in Kigali. We used a thematic approach to analysis with a coding framework guided by Consolidated Framework for Implementation Research (intervention characteristics, inner setting, outer setting, characteristics of individuals involved in the implementation and the implementation process). Results: Key stakeholders perceived HIVST as a potentially effective initiative, which can be used in order to ensure that there is an improvement in uptake of testing services, especially for underserved populations in Rwanda. The following challenges for implementation and scale-up of HIVST were revealed: lack of awareness of the kits, high cost of the self-test kits, and concerns on results interpretation. Key stakeholders identified the following as prerequisites to the successful implementation and scale-up of HIVST in Rwanda; creation of awareness, training those involved in the implementation process, regulation of the selling of the self-test kits, reduction of the costs of acquiring the self-test kits through the provision of subsidies, and ensuring consistent availability of the self-test kits. Conclusions: Key stakeholders expressed confidence in HIVST’s ability to improve the uptake of HIV testing services. However, they reported challenges, which need to be addressed to ensure successful implementation and scale-up of the HIVST. There is a need for further research incorporating lower level stakeholders to fully understand HIVST implementation and scale-up challenges and strategies to inform policy.

scholarly journals Association of Inflammatory Markers and Blood Cell Counts and the Risk of Leukemia in the Swedish Amoris Cohort

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4382-4382
Author(s):  
Mohammad Abdus Sami ◽  
Maria Feychting ◽  
Niklas Hammar ◽  
Goran Walldius ◽  
Mieke Van Hemelrijck ◽  
...  
Keyword(s):  
Blood Cell ◽  
Inflammatory Markers ◽  
Research Funding ◽  
Fusion Gene ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Cell Counts ◽  
Blood Cell Counts ◽  
Leukemia Diagnosis

Abstract Background: The presence of myeloid-derived inflammation is associated with different malignancies, including Leukemia. Certain risk factors (i.e., age, exposure to carcinogens including chemical and radiation), common gene mutations (such as the BCR-ABL fusion gene), and inflammatory markers (such as C-reactive protein (CRP)) have been associated with the risk of developing Leukemia, however cost-effective and widely acceptable predictor markers are not yet available. This study aimed to investigate the association of standard laboratory inflammatory biomarkers and blood cell counts and the long-term risk of Leukemia in a cohort of healthy individuals. Methods: Individuals from the Swedish Apolipoprotein Risk Study (AMORIS) cohort (n=124609, Male 56.7% vs. Female 43.3 ,&gt;20 years of age) with baseline measurements of C-reactive protein (CRP), albumin, haptoglobin, white blood cell count, mean corpuscular volume (MCV) and platelets were included in the study. Multivariable cox proportional hazard regression analysis adjusted for age, sex, comorbidities (CCI), and socioeconomic status was performed to assess the association of the biomarkers and leukemia diagnosis (ICD-7 (204) Swedish National Cancer Register linkage). Individuals with a leukemia diagnosis within a year of the blood measurement were excluded to account for reverse causation. Considering the time of diagnosis and version of ICD, which was used, it was not possible to stratify patients based on current leukemia classification, including myeloid/ lymphoid or acute/ chronic. Results: A total of 218 participants (0.2%) developed leukemia over a median follow-up time of 17.54 years. Albumin (leukemia free mean=43.23 vs leukemia mean=42.90 (g/l); p&lt;.001) WBC (leukemia free mean=6.62 vs leukemia mean=9.71 (WBC*×10 9/L); p&lt;.001) and platelets (leukemia free mean=257.00 vs leukemia mean=248.99 (Platelets×10 9/L); p&lt;.001) were all statistically significantly associated with risk of leukemia. When analyzing continuous values, the Hazard Ratio (HR) of albumin was: 1.04 (95%Confidence Interval (CI): 0.98-1.09); the HR of WBC was: 1.09 (95%CI 1.08-1.10) and HR for platelets was: 0.99 (95%CI 0.99-1.00). The analyses of the quartiles presented similar trends, albumin (HR Q4 vs Q1: 1.45 (95%CI 0.90-2.32);HR Q3 vs Q1: 1.62 (95%CI 1.04-2.52); HR Q2 vs Q1: 1.80 (95%CI 1.17-2.78)) (p for trend= 0.006), WBC (HR Q4 vs Q1: 3.57 (95%CI 2.38-5.36) ;HR Q3 vs Q1: 1.50 (95%CI 0.96-2.37); HR Q2 vs Q1: 0.84 (95%CI 0.51-1.40)) (p for trend= 0.08) and platelets (HR Q4 vs Q1: 0.77 (95%CI 0.54-1.11) ;HR Q3 vs Q1: 0.63(95%CI 0.43-0.92); HR Q2 vs Q1: 0.58 (95%CI: 0.40-0.86)) (p for trend =0.003). Conclusion: The present study presented a positive association between increasing albumin levels and high numbers of WBC and risk of Leukemia, while a negative association was found with high platelet counts, which highlight these markers as potential markers of long-term risk of Leukemia. The potential clinical use of these markers in the early detection of leukemia needs to be evaluated in further studies. Disclosures Kordasti: Alexion: Honoraria; Beckman Coulter: Honoraria; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Research Funding.

Development and Validation of a Portable Hearing Self-Testing System Based on a Notebook Personal Computer

2015 ◽  
Vol 26 (08) ◽  
pp. 716-723
Author(s):  
Yan Liu ◽  
Dong Yang ◽  
Fen Xiong ◽  
Lan Yu ◽  
Fei Ji ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Personal Computer ◽  
Normal Hearing ◽  
Standard Test ◽  
Test Method ◽  
The Self ◽  
Testing System ◽  
Self Testing ◽  
Hearing Thresholds ◽  
Self Test

Background: Hearing loss affects more than 27 million people in mainland China. It would be helpful to develop a portable and self-testing audiometer for the timely detection of hearing loss so that the optimal clinical therapeutic schedule can be determined. Purpose: The objective of this study was to develop a software-based hearing self-testing system. Research Design: The software-based self-testing system consisted of a notebook computer, an external sound card, and a pair of 10-Ω insert earphones. The system could be used to test the hearing thresholds by individuals themselves in an interactive manner using software. The reliability and validity of the system at octave frequencies of 0.25 Hz to 8.0 kHz were analyzed in three series of experiments. Study Sample: Thirty-seven normal-hearing particpants (74 ears) were enrolled in experiment 1. Forty individuals (80 ears) with sensorineural hearing loss (SNHL) participated in experiment 2. Thirteen normal-hearing participants (26 ears) and 37 participants (74 ears) with SNHL were enrolled in experiment 3. Each participant was enrolled in only one of the three experiments. Data Collection and Analysis: In all experiments, pure-tone audiometry in a sound insulation room (standard test) was regarded as the gold standard. SPSS for Windows, version 17.0, was used for statistical analysis. The paired t-test was used to compare the hearing thresholds between the standard test and software-based self-testing (self-test) in experiments 1 and 2. In experiment 3 (main study), one-way analysis of variance and post hoc comparisons were used to compare the hearing thresholds among the standard test and two rounds of the self-test. Linear correlation analysis was carried out for the self-tests performed twice. The concordance was analyzed between the standard test and the self-test using the kappa method. p < 0.05 was considered statistically significant. Results: Experiments 1 and 2: The hearing thresholds determined by the two methods were not significantly different at frequencies of 250, 500, or 8000 Hz (p > 0.05) but were significantly different at frequencies of 1000, 2000, and 4000 Hz (p < 0.05), except for 1000 Hz in the right ear in experiment 2. Experiment 3: The hearing thresholds determined by the standard test and self-tests repeated twice were not significantly different at any frequency (p > 0.05). The overall sensitivity of the self-test method was 97.6%, and the specificity was 98.3%. The sensitivity was 97.6% and the specificity was 97% for the patients with SNHL. The self-test had significant concordance with the standard test (kappa value = 0.848, p < 0.001). Conclusions: This portable hearing self-testing system based on a notebook personal computer is a reliable and sensitive method for hearing threshold assessment and monitoring.

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