scholarly journals Risk of Venous Thrombosis in Patients with Sickle Cell Trait after Orthopedic Surgery

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 417-417
Author(s):  
Jahnavi Gollamudi ◽  
Sadeer Al-Kindi ◽  
Petra Martin ◽  
Jane Little ◽  
Lalitha V. Nayak
Keyword(s):  
Logistic Regression ◽  
Sickle Cell ◽  
Orthopedic Surgery ◽  
Research Funding ◽  
Sickle Cell Trait ◽  
Knee Surgery ◽  
Orthopedic Procedures ◽  
Major Orthopedic Surgery ◽  
The Us ◽  
Hip And Knee Surgery

Abstract Introduction Sickle cell trait (SCT) is considered to confer a hypercoagulable state. Historically, venous thromboembolism (VTE, deep vein thrombosis and PE) rates for untreated patients after major orthopedic surgery (hip or knee replacement or hip fracture surgery) have been close to 4.3%, however with the introduction of post-op anticoagulation, the rates have been as low as 1.15%. Although guidelines exist regarding anticoagulation for up to 35 days after major orthopedic surgery, there are no specific recommendations for patients with SCT. The purpose of this retrospective study is to examine the rates of VTE after major orthopedic surgery in a cohort of patients with SCT. We hypothesize that rates of VTE would be higher in patients with SCT and the risk of VTE would persist beyond 35 days. Methods A commercial database (Explorys Inc, Cleveland, OH, USA), an aggregate of electronic health record data from 26 major integrated US healthcare systems representing a sixth of the US population, was queried for data, using Systematized Nomenclature of Medicine (SNOMED) clinical terms or codes. Cases were defined as patients with SCT who underwent major knee or hip surgery. Since a majority of the US population with SCT are African American (AA) patients, controls were defined as AA patients without SCT undergoing major orthopedic surgery. For the primary end point of VTE, only adult patients (≥18 years) were selected. Those with previous history of VTE, thrombophilia, malignant disease, antiphospholipid antibody syndrome and other hemoglobinopathies such as sickle cell disease were excluded. 30 and 90-day rates of VTE were recorded for both groups. Logistic regression models were used to adjust of confounding variables (defined a priori as age > 65 or< 65, smoking, gender and presence or absence of body mass index > 30). Of note, SCT is likely under-estimated due to incomplete diagnosis. Rates or proportions were compared using Chi-squared testusing Medcalc software (2018). Logistic regression analysis was done using Statistical Package for Social Sciences (SPSS, version 21, IBM Corp, Armonk, NY). P< 0.05 was considered statistically significant. Results A total of 1360 major orthopedic surgeries in patients with SCT and 74040 surgeries in non-SCT patients were identified. 30 and 90-day VTE for SCT patients undergoing major orthopedic surgery was 9.7% each. 30 and 90 day VTE for non-SCT patients undergoing major hip and knee surgery were 5.9 % and 6.4 % respectively. The difference in 30-day and 90-day VTE rates between the SCT and non-SCT group was statistically significant (30 day VTE difference 3.1%, 95% CI 1.6650-4.7569, p < 0.001; 90 day VTE difference=3.6%; 95% CI 2.1658-5.2562, p= <0.001). The rates of anticoagulant dispensation (oral Xa inhibitors, enoxaparin or warfarin) after surgery were 56% and 46% in SCT and non-SCT group respectively (difference = 10%, 95% CI 7.32-12.64, p <0.001). Despite the higher proportion of patients prescribed for anticoagulants in the SCT population, there was still a higher 30 and 90-day VTE rate in that group. Compliance to anticoagulation and mortality from VTE could not be assessed in this study. Logistic regression of risk factors associated with risk of VTE revealed age over 65 years of age, female gender, active smoking status, obesity (BMI >30), and presence of sickle cell trait were all significantly associated with increased risk of both 30 and 90 day VTE post major orthopedic surgery. Please see Table 1 and 2 for further details. Conclusion Our study represents real life data outside of a clinical trial. We found that patients with SCT who underwent major hip and knee surgery had an increased 30 and 90-day VTE rates compared to non-SCT patients undergoing the same procedures. Overall, this cohort of AA patients had VTE rates higher than that were described in literature. Of note, AA patients overall are at a higher risk of VTE than are their Caucasian counterparts. The results from the study seem to suggest a role for extended prophylaxis in people with SCT who are undergoing orthopedic procedures, and warrants further study. Disclosures Little: Doris Duke Charitable Foundations: Research Funding; NHLBI: Research Funding; PCORI: Research Funding; Hemex: Patents & Royalties: Patent, no honoraria.

scholarly journals COVID Symptoms and COVID Anxiety in Sickle Cell Disease

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 16-17
Author(s):  
Wally R Smith ◽  
Benjamin Jaworowski ◽  
Shirley Johnson ◽  
Thokozeni Lipato ◽  
Daniel M Sop
Keyword(s):  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Research Funding ◽  
Telephone Survey ◽  
Cell Disease ◽  
Weighted Mean ◽  
The Us ◽  
Associated Symptoms ◽  
At Home

Background Even before the US upswing of the current COVID pandemic, the number of sickle cell disease (SCD) patients coming to hospitals and EDs appeared to fall drastically. This happened despite SCD patients having often been heavy utilizers of the ED and hospital for their iconic vaso-occlusive crises (VOC). Though ambulatory SCD clinics quick converted largely to telehealth in order to comply with stay-at-home orders designed to suppress person-to-person transmission, some SCD patients appeared to avoid care, delay care, or refuse doctors' invitations for care. Presumably patients did so out of COVID fears, but this has not been confirmed in the literature. Further, whether these patients had COVID symptoms but stayed at home has not been studied. As part of quality improvement (QI) to conduct COVID surveillance in an adult sickle cell program, we sought to explain and predict SCD health care utilization patterns we were observing, as well as to determine urgent physical and mental health needs of patients who appeared to be avoiding care. Methods Fifteen staff in the Adult Sickle Cell Medical Home at Virginia Commonwealth University, a large urban academic medical center, conducted a telephone survey ("wellness check"was used when we talked to patients) of all known adults with SCD over 19 days in 2020. A staff member confirmed the patient had SCD, asked permission to proceed, then asked about symptoms consistent with COVID-19. At the end of the telephone survey, respondents wer invited to complete an email survey of sickle cell and COVID-19 utilization attitudes (19-33 items, depending on the response pattern, either drawn from the National Health Interview Survey, from the Adult Sickle Cell Quality of Life Measurement quality of care survey, or drafted by the authors), the Sickle Cell Stress Survey-Adult (SCSS-A, a 10-item previously validated survey), and anxiety and depression (PHQ9 of the PRIME-MD). Results Of 622 adults approached by phone call, 353 responded to the following yes/no screening questions regarding the prior 14 days: fever over 100 F 0/353 (0.00%); cough 3/353(0.01%); difficulty breathing 0/353(0.00%); unexplained shortness of breath 2/353(0.01%); sore throat 2/353 (0.01%); unexplained muscle soreness 2/353(0.01%);contact with anyone who tested positive for COVID-19 2/353(0.01%); testing for COVID 19 6/353(0.02%). For QI purposes, we set a threshold of three or more COVID-associated symptoms or the presence of fever as criteria requiring intense telephone or in-person staff monitoring for the following week. Only three patients met criteria. A total of 219/353 had email surveys sent. Of 63 patients (28.8%) who returned email surveys by June 10, 2020, 35.9% had already managed a "pain attack" at home 4 or more times in the prior 12 months, and 45.5% of these said their bad ER experiences were very or somewhat important in that decision. In the prior 14 days, although 30/64 reported a crisis for at least one day, only 4/64 had visited the Emergency Department for pain. On a 0-10 scale, 21/61 patients endorsed "0" for worry that they would be COVID-infected by going for medical care (weighted mean 3.9), but 18/59 endorsed "10" for worry they were more at risk of COVID because of SCD (weighted mean 6.31), and 22/60 endorsed "10" for worry they would fare worse than others if COVID infected (weighted mean 6.97). Many patients forwent "needed" care (16/62) or delayed "needed" care by at least a day (36/61). Eleven patients met criteria for moderately severe to severe depression on the PHQ-9, and 28/63 somewhat or strongly agreed with the statement "death is always on the back of my mind" on the SCSS-A. Conclusions In adolescents and adults with SCD, many were already reticent to come to the ED for pain, but a significant portion reported delays or avoidance of needed care during the early stages of the US COVID pandemic, and few reported using the ED despite over half reporting at least one crisis day in 14. Patients nonetheless reported very few COVID-associated symptoms. Fears of COVID infection/susceptibility may limit visits for needed sickle cell care among adults. Acknowledgements: Mica Ferlis RN, FNP, Caitlin McManus, RN, FNP, Emily Sushko, RN, FNP, Justin West, RN, Kate Osborne, RN, Stefani Vaughan-Sams, Marla Brannon, BS, Nakeiya Williams, BS Disclosures Smith: GlycoMimetics, Inc.: Consultancy; Emmaeus Pharmaceuticals, Inc.: Consultancy; Novartis, Inc.: Consultancy, Other: Investigator, Research Funding; Global Blood Therapeutics, Inc.: Consultancy, Research Funding; Shire, Inc.: Other: Investigator, Research Funding; NHLBI: Research Funding; Patient-Centered Outcomes Research Institute: Other: Investigator, Research Funding; Health Resources and Services Administration: Other: Investigator, Research Funding; Incyte: Other: Investigator; Pfizer: Consultancy; Ironwood: Consultancy; Novo Nordisk: Consultancy; Imara: Research Funding; Shire: Research Funding.

Untersuchung zum postoperativen Verlauf bei Patienten mit Hämophilie

2012 ◽  
Vol 32 (S 01) ◽  
pp. S45-S47 ◽  
Author(s):  
S. Krekeler ◽  
S. Alesci ◽  
W. Miesbach
Keyword(s):  
Surgical Procedures ◽  
Orthopedic Surgery ◽  
Hip Replacement ◽  
Orthopedic Procedures ◽  
Vein Thrombosis ◽  
Major Orthopedic Surgery ◽  
Lung Embolism ◽  
Total Knee ◽  
Deep Vein ◽  
Observation Period

SummaryThromboembolic complications may occur in patients with major operations even after routine thromboprophylaxis with low-molecularweight-heparin. In this retrospective, single center survey the post-operative course of patients with haemophilia was investigated. Patients, methods Overall, the postoperative course in 85 patients with haemophilia A and B (median age: 43 years, 18–73 years) and 139 surgical procedures was analyzed. The surgical procedures mainly consist of major orthopedic surgery (58 total knee replacement, 15 hip replacement, 17 other major orthopedic surgery, 15 minor orthopedic procedures). Additional surgical procedures were abdominal-surgical (18), urological (8), neurosurgical (5). Results During the post-operative observation period a small number of wound healing complications occurred (4%). None of the patients developed symptomatic deep vein thrombosis or lung embolism. Conclusion There seems to a decreased risk of postoperative thromboembolism in patients with haemophilia.

scholarly journals Risk of Pregnancy-Related Venous Thromboembolism in Black Women with Sickle Cell Trait

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2044-2044
Author(s):  
Tijesunimi Oni ◽  
Manuela Plazas Montana ◽  
Mamie Myo Thant ◽  
Sarah Baghdadi ◽  
Jaanvi Mahesh ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Black Women ◽  
Sickle Cell ◽  
Research Funding ◽  
Sickle Cell Trait ◽  
Post Partum ◽  
Search Term ◽  
Vein Thrombosis ◽  
Increased Risk ◽  
Privately Held

Abstract Background: Select inherited thrombophilias have been shown to potentiate the risk of venous thromboembolism (VTE) during pregnancy and the post-partum period. Sickle cell trait (SCT) is associated with an increased risk of VTE in the general Black population; however, prior studies investigating the risk of pregnancy-related VTE among women with SCT have been limited by an overall low number of VTE events. We, therefore, designed a retrospective cohort enriched for pregnancy-related VTE events among Black women at Johns Hopkins Hospital to address this question. Methods: We generated a cohort enriched for pregnancy-related VTE at Johns Hopkins or affiliate hospitals from 2009-2019 by using EPIC and an internal ObGyn database to identify Black women ≥18 years with at least 1 pregnancy encounter in addition to at least 1 VTE-related ICD-10 diagnosis code or comprehensive VTE-related search term. All charts were manually reviewed to confirm hemoglobinopathy status and to verify the presence or absence of a VTE event during pregnancy or 6 weeks post-partum. Individuals with sickle cell disease, history of VTE prior to index pregnancy, catheter-related or superficial vein thrombosis only, or unknown pregnancy VTE outcome were excluded. Results: A total of 418 women were included for analysis. The mean age at pregnancy was 30 years (range 18-48), and the prevalence of SCT was 6.7%, which is similar to the prevalence in the general Black American population. Thirty-seven women (8.9%) were confirmed to have a pregnancy-related VTE event. Among those with VTE, SCT carriers demonstrated a higher proportion of pulmonary embolism (PE), unusual vein thrombosis, and antepartum VTE events compared to women with HbAA (Table 1), though numbers were small. After adjusting for age, the risk of VTE was 2.9-fold (95% CI 1.1-7.9) higher among pregnant Black women with SCT compared to those without. Conclusions: In this enriched cohort, SCT was associated with an increased risk of pregnancy-related VTE among Black women. The pattern of pregnancy-related VTE was different in individuals with SCT compared to those with HbAA, with SCT demonstrating a higher proportion of PE and antepartum events. The higher risk of PE compared to isolated DVT is similar to the pattern observed in prior population-based studies of SCT. Because the prevalence of SCT is high and the overall risk of VTE in pregnancy is low, future studies are needed to determine whether routine thromboprophylaxis is warranted for select high-risk pregnant women with SCT. Figure 1 Figure 1. Disclosures Lanzkron: Novartis: Research Funding; CSL Behring: Research Funding; Shire: Research Funding; Novo Nordisk: Consultancy; Imara: Research Funding; Bluebird Bio: Consultancy; Pfizer: Current holder of individual stocks in a privately-held company; Teva: Current holder of individual stocks in a privately-held company; GBT: Research Funding. Naik: Rigel: Research Funding.

scholarly journals Young Adults with Sickle Cell Disease (SCD) Have Low Interest in Genetic Counseling and Sickle Cell Trait Testing for Sexual Partners

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 1-2
Author(s):  
Elizabeth Williams ◽  
Elizabeth Linton ◽  
Rosalyn Stewart ◽  
Sophie M. Lanzkron ◽  
Lydia H. Pecker
Keyword(s):  
High School ◽  
Young Adults ◽  
Genetic Counseling ◽  
Young Adult ◽  
Reproductive Health ◽  
Sickle Cell ◽  
Research Funding ◽  
Sickle Cell Trait ◽  
Full Time ◽  
Transition Readiness

Introduction The 2014 NHLBI Sickle Cell Expert Panel recommends that young adults with sickle cell disease (SCD) be supported to develop a reproductive life plan, but little data about implementing this recommendation exists and reproductive health behaviors or knowledge is not assessed in existing SCD transition readiness forms. Young adults with SCD confront typical age-related reproductive challenges and require additional support due to SCD-related complexities. For men and women, there are questions about the effect of SCD and its treatments on fertility and reproductive lifespan and the problem of genetic risk for SCD in offspring. For men, priapism and erectile dysfunction may be problems, while women face contraception choices and complicated pregnancy care. In our young adult clinic, we assess young adults' reproductive history, intentions and knowledge using a clinical survey and standard intake questions. The purpose of this study was to describe young adult responses to our family planning survey. Methods This is a retrospective analysis of patients who established care at the Johns Hopkins Sickle Cell Center for Adults' Young Adult Clinic (YAC), which serves young adults with SCD &lt;31 years. The survey is administered to all new patients, consists of 10 questions and has a Flesch-Kincaid Grade Level score of 6. A systematic chart review captured respondent demographic data to characterize the responses. Results Fifty patients who established care in the YAC over its first 15 months (April 2019-July 2020) completed the survey. They were 66% female with a median age of 23.5 (IQR 21,25). Most (74%) had sickle cell anemia (SCA); 60% had education beyond high school. Most (78%) were either students (34%) or employed full time (44%). Forty-two percent lived with a parent. Most (68%) were sexually active, and 45% reported contraception use. Condoms were commonly used by both sexes (41%); forty percent of women used depot-medroxyprogesterone acetate (DMPA). Half of women (58%) had a gynecologist. One third of women reported dysmenorrhea. Forty-one percent of men reported priapism. Twenty-four percent of respondents had a history of pregnancy or of impregnating a partner and 14% had children. The median age of parents at the birth of the first child was 21 (IQR 16,22). Survey results are in Table 1. The response rate was 98% for eight questions and 50% for two questions. Few (8%) reported desire to have a child in the next year, and 27% wished to discuss contraception. Among sexually active respondents, 29% knew their partner's sickle cell trait status and 35% of them wanted testing. Few respondents wanted to meet with a genetics counselor (12%) or reported knowledge of preimplantation genetic testing (PGT) (11%). Thirty-eight percent of respondents were interested in learning how to identify if a fetus has SCD. Ninety-two percent of respondents indicated they do not desire pregnancy in the next year, and 38% of them were using contraception - 33% used condoms, 22% used DMPA, and 11% had an intrauterine device (IUD). Those interested in contraception were young (68% under 26), female (77%), and, of those women, most did not have a gynecologist (60%). Most women with dysmenorrhea (63%) were not interested in discussing contraception. Of the 14% of respondents with children, 29% knew their partner's trait status; and of those who did not, 20% wanted testing. Among 10 patients interested in genetic counseling or who knew of PGT, half had more than high school education; most (70%) were women with SCA who had never been pregnant. Among 82% who had not heard of PGT, 17% identified interest in more information. Most (70%) of this group was 22-25 years old, 14% wanted a child in the next year, all were either students (43%) or employed full time (57%); most (57%) had education beyond high school. Conclusions Clinic administration of a family planning survey is feasible. Many young adults transition to adult care and are parents or interested in becoming parents. Ninety-two percent of respondents do not desire pregnancy in the near future but 67% of them are not using reliable birth control. Genetic counseling interest, knowledge of PGT, and knowledge of partner sickle trait status is low. Current transition readiness documents for SCD do not adequately address reproductive health. These results suggest a discordance between the reproductive health priorities of young adults with SCD and providers that should be further examined. Disclosures Stewart: HRSA: Research Funding. Lanzkron:GBT: Research Funding; HRSA: Research Funding; Ironwood: Research Funding; NHLBI: Research Funding; PCORI: Research Funding; Pfizer: Research Funding; Pharmacy Times Continuing Education: Honoraria; Prolong: Research Funding. Pecker:Forma Therapeutics: Consultancy.

Dabigatran in the prevention of venous thromboembolism after major orthopedic surgery

2009 ◽  
Vol 10 (3) ◽  
pp. 115-128
Author(s):  
Orietta Zaniolo
Keyword(s):  
Venous Thromboembolism ◽  
Orthopedic Surgery ◽  
Cost Savings ◽  
Orthopedic Procedures ◽  
Thrombin Inhibitor ◽  
Major Advance ◽  
Vte Prophylaxis ◽  
Life Years ◽  
Mechanical Methods ◽  
Major Orthopedic Surgery

Venous thromboembolism (VTE) is a very frequent surgical complication, especially in major orthopedic procedures. Prophylaxis with pharmacological agents, including warfarin and subcutaneous injection of either low-molecular weight heparin (LMWH) or low-dose unfractionated heparin, and/or with mechanical methods has been shown to be effective and safe. Despite recommendations on the routine implementation of these prophylaxis methods, some surveys demonstrate that many patients currently don’t receive any prophylaxis. The recent introduction of dabigatran etexilate, a novel oral direct thrombin inhibitor approved for VTE prophylaxis in total knee and hip substitution, represents a major advance in the provision of efficient anticoagulation therapy. Two pivotal randomized controlled multicenter trials assessed non-inferiority of dabigatran 150/220 mg/day versus enoxaparin 40 mg/day in the prevention of VTE after hip and knee replacement. From an economical point of view, an English modeling study on dabigatran cost/effectiveness showed it to be associated with lower cost and slightly higher gain in Quality Adjusted Life Years, thus dominating enoxaparin. Other analyses obtained results consistent with these, estimating inferior costs related to the use of dabigatran with respect to low weight heparin; this difference was mainly due to health personnel work for heparins subcutaneous administration. In Italy, acquisition costs for a 28-35 days therapeutic cycle of main antithrombotic drugs vary between 70 and 170 €, according to different distribution policy. Dabigatran, with a cost of 117 €, holds a medial position. Cost savings related to oral administration may partially offset the price difference between dabigatran and the less expensive options among LMWHs or, compared with the more expensive ones, add to pharmaceutical cost savings. In order to increase the effectiveness of VTE prophylaxis, the improvement of patient adherence to the prescribed strategy is needed. On this plane, dabigatran may be associated to some advantages, like the lack of drug and food interactions, the need for less frequent coagulation monitoring compared to vitamin K antagonists, and obviation of daily injections of parenteral agents. In conclusion, these considerations suggest that dabigatran may prove an interesting alternative in VTE prevention in orthopedic surgery.

scholarly journals Prevention of VTE in orthopedic surgery patients

2013 ◽  
Vol 14 (2S) ◽  
pp. 1-36
Author(s):  
Federico Spandonaro ◽  
Rossella Letizia Mancusi ◽  
Lorenzo Terranova ◽  
Diana Giannarelli ◽  
Paolo Grossi ◽  
...  
Keyword(s):  
Orthopedic Surgery ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
National Level ◽  
Financial Impact ◽  
Orthopedic Procedures ◽  
Thromboembolic Complications ◽  
Increased Risk ◽  
Major Orthopedic Surgery ◽  
The Cost

Venous thromboembolism (VTE) is defined as the obstruction, partial or complete, of one or more veins of deep circulation. It is a condition that can lead to a deterioration in his state of health until death, manifesting as deep vein thrombosis (DVT) or pulmonary embolism (PE). The major orthopedic surgery and the surgical oncology are frequently associated with thromboembolic complications, because of conditions that are often critical in these patients. It is estimated that in Italy DVT has an incidence that varies between 50 and 150 new cases per 100,000 population, while the prevalence would be between 2.5 and 5%. In the absence of thromboprophylaxis, the orthopedic surgery lead to a high increased risk of VTE. In elective hip replacement, in the absence of prophylaxis, the incidence of DVT and of fatal PE is about 50% and 2% respectively. In elective knee arthroplasty the risk of venous thromboembolic complications is even higher. It is estimated that 56.2% of the costs of prophylaxis with Low Molecular Weight Heparin (LMWH) in patients undergoing major orthopedic surgery are attributable to the cost of drugs (about € 200), followed (with 44.8%) by the cost of administration (approximately € 159). The average total cost/day was estimated at € 8 per patient. In Italy, it has been estimated an annual cost for new cases between 215 and 260 million €. The clinical advantages of the New Oral Anticoagulants (NOA) appear to be substantially clear, the major concern with regard to their reimbursement is therefore linked to the financial impact, due to the higher cost per day of the NOA compared with LMWH. To this end, it was built a model of budget impact, in the perspective of the Italian NHS, from the data related to cases of major surgical orthopedic procedures and a meta-analysis on the pivotal RCT, which aims to measure the differential effects in terms of prevention of VTE. The results show that the financial impact of the NOA in the prophylaxis of major orthopedic surgery is not particularly relevant. In fact, the major pharmaceutical costs that, at national level, amount to € 10.8 mil. (€ 15.2 mil. in the case of prolonged prophylaxis in knee operations) would be more than offset by savings in terms of fewer treatments of VTE, which is based on the assumption of more than 4,000 cases, up to about 6,600 in hypothesis best efficacy.

scholarly journals Validity of HbA1c in Diagnosing Diabetes Among People with Sickle Cell Trait in Tanzania

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4852-4852
Author(s):  
Belinda Kweka ◽  
Eric Lyimo ◽  
Jeremiah Kidola ◽  
Suzanne Filteau ◽  
Henrik Friis ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Sickle Cell ◽  
G6pd Deficiency ◽  
Conflicts Of Interest ◽  
Sickle Cell Trait ◽  
Categorical Variables ◽  
Oral Glucose ◽  
Diabetes Diagnosis ◽  
North Western ◽  
Western Tanzania

BACKGROUND: Hemoglobin A1c (HbA1c) measures the average of the past three month's glucose concentration and is recommended for diagnosing and monitoring diabetes. However in people with shorter red blood cells life spans like those with sickle cell trait (SCT), the test may underestimate the prevalence of diabetes. There are no data on the extent of this problem in East African region where the prevalence of SCT approaches 22%. OBJECTIVE: To compare diabetes diagnosis outcomes among adults with and without SCT by HbA1c and 2hrs oral glucose tolerance test (OGTT). METHODOLOGY: This was a cross sectional study conducted among patients who were previously recruited in the Chronic Infection, Cormobidities and Diabetes in Africa (CICADA) study, a cohort study investigating risk factors for diabetes in North western Tanzania during 2016 to 2021. Participants were included in this study if aged ≥18 years and were residents of Mwanza. After identification of eligible participants, stored blood samples were analyzed for SCT and other hemoglobinopathies i.e. thalassemia and G6PD deficiency through gene extraction, PCR and gel electrophoresis. Demographic, and anthropometric data as well as HbA1c and OGTT, hemoglobin, and lipids test results were available as part of CICADA study. Data were managed and analysed in stata. Student ttest was used for comparison of continuous variables while for categorical variables chi squire test was used. To investigate the validity of HbA1c, regression models were used to evaluate the association between SCT and diabetes diagnosis by HbA1c and OGTT separately. P< 0.05 indicated significant differences. RESULTS: 480 participants were included. Their mean age was 40.8 (±11.8) years, 292 (60.8%) were females, 128 (26.7%) had SCT and no sickle cell disease(SCD) which is homozygous trait observed. Those with SCT had lower body mass index (BMI) ((21.6(±4.3) vs. 22.5 (±5.0), P= 0.01) and lower HbA1c (5.2% vs. 5.9%, P<0.0001) compared to those without SCT. In multivariable logistic regression analysis adjusted for sex, age, BMI, another hemoglobinopathy which is thalassemia , G6PD deficiency , hemoglobin and lipids , participants with SCT were 88% less likely to be diagnosed with diabetes by HbA1c compared to those without SCT (OR=0.12, 95% CI (0.1,0.2), P <0.001). In contrast to logistic regression model adjusted for the same variables as above, SCT was not associated with diabetes diagnosis by OGTT (1.44, 95% CI (0.9, 2.3), P= 0.12). CONCLUSION: When compared with OGTT the findings shows that HbA1c systematically underestimate the prevalence of diabetes among people with SCT. The use of HbA1c for diabetes diagnosis should be done with caution especially in areas with high prevalence of SCT like in North Western Tanzania. Further research is needed to optimize the use of HbA1c in diagnosing and monitoring diabetes among people with SCT. Disclosures No relevant conflicts of interest to declare.

High Rate of Deep-Vein Thrombosis in Asia after Major Orthopedic Surgery: The AIDA Study Final Results.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2580-2580
Author(s):  
Franco Piovella ◽  
Ching-Jen Wang ◽  
Housan Lu ◽  
Lee Kenneth ◽  
Lai Heng Lee ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Orthopedic Surgery ◽  
Lower Limbs ◽  
High Rate ◽  
Orthopedic Procedures ◽  
Thrombosis Prophylaxis ◽  
Vein Thrombosis ◽  
Asian Patients ◽  
Major Orthopedic Surgery ◽  
Deep Vein

Abstract Background: The incidence of post-surgical venous thromboembolism is thought to be low in Asian populations and routine thromboprophylaxis is not implemented. Objective: In this large multinational, multiethnic study, we evaluated the incidence of deep-vein thrombosis (DVT) patients undergoing major orthopedic surgery of the lower limbs. Methods: We performed a prospective epidemiological study in 19 centers across Asia (China, Indonesia, South Korea, Malaysia, Philippines, Taiwan and Thailand) in patients undergoing elective total hip replacement (THR), total knee replacement (TKR) or hip fracture surgery (HFS) not receiving pharmacological thromboprophylaxis. The primary endpoint was the rate of DVT of the lower limbs objectively documented by mandatory bilateral ascending venography performed 6 to 10 days after surgery and evaluated by a blinded central adjudication committee. Results: Overall, 407 Asian patients (20–99 years) undergoing THR (n=175), TKR (n=136) or HFS (n= 96) were recruited in 19 centres. 72.5% of the enrolled patients had adequate venograms. Total DVT was diagnosed in 121 of 295 evaluable patients (41.0%, [95% confidence interval: 35.4–46.7]). Proximal DVT was found in 30 patients (10.2% [7.0–14.2]). Total DVT and proximal DVT rates were the highest in TKR patients (58.1% and 17.1%, respectively), followed by HFS patients (42.0% and 7.2%, respectively), then THR patients (25.6% and 5.8%, respectively). DVT was more frequent in female patients aged at least 65 years. By-country analysis showed that the highest DVT rate was observed in Indonesia (78.6%) and the lowest in China (24.3%). By ethnic group, the lowest DVT rate was observed in Koreans (29.8%), while similar results were found in Chinese (45.0%) and in other non-Korean non-Chinese (46.3%) ethnic groups. Pulmonary embolism was clinically suspected in 10 of 407 patients (2.5%) and objectively confirmed in two patients (0.5%). Conclusions: Venographically detected thrombosis is well recognized as an appropriate surrogate for symptomatic outcomes and is the basis for the recommendation for routine prophylaxis in Western patients. The high rate of venographic thrombosis in Asian patients is similar to that observed in patients in Western countries. Thrombosis prophylaxis should therefore be considered in Asian patients undergoing major orthopedic procedures.

VTE Prophylaxis Across the Continuum of Care in US Orthopedic Surgery Patients.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2097-2097
Author(s):  
Alpesh Amin ◽  
Jay Lin ◽  
Amy Ryan
Keyword(s):  
At Risk ◽  
Orthopedic Surgery ◽  
Research Funding ◽  
Significant Risk ◽  
Post Discharge ◽  
Vte Prophylaxis ◽  
Individual Patient Level ◽  
Hip Fracture Surgery ◽  
Major Orthopedic Surgery ◽  
Patients At Risk

Abstract Abstract 2097 Poster Board II-74 Background: Patients who undergo major orthopedic surgery are at significant risk of developing VTE. As 40-60% of orthopedic surgery patients develop VTE in the absence of thromboprophylaxis, evidence-based guidelines recommend pharmacological VTE prophylaxis in all patients without contraindications. As the risk of VTE persists beyond discharge in these patients, the use of LMWH and warfarin post-discharge is both suitable and recommended. However, a lack of awareness and education often leads to an absence of VTE prophylaxis post-discharge. This analysis evaluated in-hospital and post-discharge VTE prophylaxis patterns for US orthopedic surgery patients. Methods: Premier's Perspective” inpatient data were cross-matched at the individual patient level with Ingenix LabRx® outpatient data from the I3 database (January 2005-December 2007) to assess VTE prophylaxis patterns in major orthopedic surgery (total knee arthroplasty, total hip arthroplasty, hip fracture surgery) patients at risk of VTE (according to the American College of Chest Physicians 2004 guidelines) and with no contraindications for anticoagulation. Inpatients were assessed for the anticoagulant received in-hospital and were followed post-discharge to assess their outpatient prophylaxis use. Drug utilization and clinical practice patterns during and within 30 days after hospitalization were collected and compared descriptively between groups. Results: Of the 3,311 orthopedic surgery discharges at risk of VTE and included in this analysis, only 295 (8.9%) did not receive any anticoagulation at all. Of the remaining 3,016 (91.1%) discharges that did receive anticoagulation, 1,061 (35.2%) received enoxaparin, 1,028 (34.1%) received warfarin, and the remaining 927 (30.7%) received other or combination prophylaxis. However, after discharge only 1,800 (54.4%) of all patients received prophylaxis, with the majority receiving warfarin (1,028, 57.1%). The remaining 1,511 (45.6%) received no outpatient prophylaxis (Table). Conclusion: This analysis presents both inpatient and outpatient VTE prophylaxis patterns in real-world orthopedic surgery patients that are at risk of VTE. Although the rate of prophylaxis was high in inpatients, approximately half of all patients had no prophylaxis post-discharge. Further efforts to improve VTE prevention in discharged orthopedic surgery patients are required. Disclosures: Amin: sanofi-aventis: Research Funding, Speakers Bureau, The authors received editorial/writing support in the preparation of this abstract funded by sanofi-aventis U.S., Inc. . Lin:sanofi-aventis: Employment. Ryan:sanofi-aventis: Research Funding.

scholarly journals Content Validation of the Sickle Cell Pain Diary-Self Report

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2277-2277
Author(s):  
Miranda Bailey ◽  
Patricia Stebbins ◽  
Denise D'Alessio ◽  
Kimberly Raymond ◽  
Michelle K White
Keyword(s):  
Sickle Cell ◽  
Research Funding ◽  
Qualitative Interviews ◽  
Self Report ◽  
Content Validation ◽  
Expert Review ◽  
Patient Interviews ◽  
The Us ◽  
The Impact ◽  
Response Choices

Abstract Background: Sickle Cell Disease (SCD) is a genetic, progressive, vascular disease that affects approximately 100,000 children and adults in the US. Vaso-occlusive crises (VOCs), also referred to as pain crises, are a primary complication of SCD. VOCs are thought to be caused by several factors, including inflamed, damaged vasculature and increased cellular adherence to the endothelium and other cells, resulting in occlusion of the microvascular system. VOCs have been associated with increased morbidity and mortality. Healthcare visit data partially reflect VOC and SCD outcomes and provide an understanding of healthcare resource utilization (HCRU). However, evaluating only HCRU data misses the breadth and depth of the patient experience and burden of SCD as it fails to capture daily variations of pain and other important quality of life (QoL) concepts. Additionally, patients who avoid seeking care outside the home are not represented in HCRU data. The Sickle Cell Pain Diary- Self Report (SCPD-S) was developed as a daily patient-reported outcome (PRO) measure primarily intended to capture the frequency and severity of SCD-related pain during and outside of a VOC and secondarily to examine the impact of the pain on other patient-relevant QoL concepts. The objective of this study was to investigate the content validity of the SCPD-S. Methods: A draft diary was developed from the literature. In line with FDA guidance for PRO development, the content validation of the SCPD-S included four consecutive steps: (1) literature review to identify important concepts to measure and mapping of concepts to draft diary; (2) expert review to improve wording and layout; (3) round 1 (N=13) of qualitative interviews with patients; and (4) round 2 (N=6) of qualitative interviews with patients. Revisions made to the diary after each step were tested in the following step. In total, 18 in-depth, hybrid concept elicitation (CE) and cognitive debriefing (CD) interviews were conducted in English in person (n=13) and by phone (n=5) with SCD patients in the US aged ≥12 years. A semi-structured guide was used to explore concepts relevant to patients' experience with VOCs and to test the draft diary. The CD portion of the interviews required patients to state their thoughts while reading the diary aloud, after which interviewers probed on areas that seemed confusing and asked questions specific to the diary instructions, recall period, items, and response choices. All interviews were recorded, transcribed, coded and analyzed. Results: All four steps of this content validation study resulted in changes to the SCPD-S. The literature review, expert review, and round 1 patient interviews resulted in expansion of the SCPD-S from 8 to 19 items covering concepts highlighted by patients as important. For example, impact of VOCs on school/work, activities of daily living, social and recreational activities, sleep, and emotional wellbeing were added. Five items from the original diary were significantly revised, as were all response choices. Round 2 interviews confirmed the comprehensiveness of the revised diary, comprehensibility of the wording, and appropriateness of the recall period and response choices. Final changes to the diary included adding skip logic to ensure transition to an electronic format. Saturation analyses revealed that no additional interviews were needed. Conclusions: This study provided evidence that supports the content validity of the SCPD-S, a self-report SCD daily diary focused on capturing daily variations of pain in SCD. Evidence gathered during patient interviews indicated that the SCPD-S is a valuable, fit for purpose measure of VOC-related pain frequency and severity as well as the impact of this pain on other QoL concepts including fatigue and emotional health. In addition, the diary captures the QoL of patients who may not seek care outside the home providing a more holistic view of the overall impact of VOCs and SCD. The numerous changes to the SCPD-S as a result of the study findings highlight the importance of the content validation process in establishing a PRO measure. Future work on the SCPD-S includes development of a scoring algorithm and user's manual, and conducting psychometric validation. Use of the SCPD-S is anticipated in future clinical trials enrolling patients who experience VOCs as a way to help capture the QoL impacts of new interventions designed to reduce the frequency and intensity of VOCs. Disclosures Bailey: Novartis: Employment. Stebbins:Optum: Employment; Novartis: Research Funding. D'Alessio:Novartis: Employment. Raymond:Novartis: Research Funding; Optum: Employment. White:Akcea: Research Funding; Optum: Employment.

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