Factors Associated with Attrition of Adult Participants in a Longitudinal Database: A National Institute on Disability, Independent Living, and Rehabilitation Research Burn Model System Study

2019 ◽  
Vol 41 (2) ◽  
pp. 270-279 ◽  
Author(s):  
Alyssa M Bamer ◽  
Kara McMullen ◽  
Nicole Gibran ◽  
Radha Holavanahalli ◽  
Jeffrey C Schneider ◽  
...  
Keyword(s):  
Independent Living ◽  
Model System ◽  
Stepwise Logistic Regression ◽  
Research Projects ◽  
Related Factors ◽  
Time Points ◽  
Factors Associated ◽  
Increased Risk ◽  
Study Results

Abstract Participant attrition in longitudinal studies can lead to substantial bias in study results, especially when attrition is nonrandom. A previous study of the Burn Model System (BMS) database prior to 2002 identified participant and study-related factors related to attrition. The purpose of the current study was to examine changes in attrition rates in the BMS longitudinal database since 2002 and to revisit factors associated with attrition. Individuals 18 years and older enrolled in the BMS database between 2002 and 2018 were included in this study. Stepwise logistic regression models identified factors significantly associated with attrition at 6, 12, and 24 months postburn injury. The percentage of individuals lost to follow-up was 26% at 6 months, 33% at 12 months, and 42% at 24 months. Factors associated with increased risk of loss to follow-up across two or more time points include male sex, lower TBSA burn size, being unemployed at the time of burn, shorter duration of acute hospital stay, younger age, not having private health insurance or workers’ compensation, and a history of drug abuse. Retention levels in the BMS have improved by at least 10% at all time points since 2002. The BMS and other longitudinal burn research projects can use these results to identify individuals at high risk for attrition who may require additional retention efforts. Results also indicate potential sources of bias in research projects utilizing the BMS database.

scholarly journals Perinatal Asphyxia: Factors Associated with Noncompliance in the specialized Outpatient Treatment

2019 ◽  
Vol 21 (2) ◽  
pp. 175
Author(s):  
Záira Moura da Paixão Freitas ◽  
Carlos Umberto Pereira ◽  
Débora Moura da Paixão Oliveira ◽  
Clarissa Melo Menezes ◽  
Edênya Santos da Silva Félix ◽  
...  
Keyword(s):  
Outpatient Treatment ◽  
Perinatal Asphyxia ◽  
Health Planning ◽  
Birth Asphyxia ◽  
Outpatient Services ◽  
Care Clinic ◽  
Factors Associated ◽  
Increased Risk ◽  
Study Results

Abstract Perinatal asphyxia is a leading cause of preventable brain injury. Between four and nine million newborns develop birth asphyxia. It is estimated that 1.2 million evolve to death and at least the same number develops important disabling neurological sequels. These children need to be accompanied by experts, especially in the first year of life. The continuity of care after hospital discharge should be guaranteed so that there is follow-up care to those who are at increased risk of morbidity and mortality. To identify factors associated with dropout of outpatient specialized treatment of children diagnosed with perinatal asphyxia. The study was conducted in neonatal care clinic specializing in a reference hospital for high-risk births in the state of Sergipe. 98 children with perinatal asphyxia discharged from the Neonatal Intensive Care Unit of this hospital participated in the study. Results: the children who were followed up were  between two months to two years old, and predominantly male 69. Ten children were discharged at age 24 months and had important neurological sequels. Thirty-one children  were discharged aged  10 to 20 months without deficit and 35  remained in regular monitoring. There was a record of 22 cases of noncompliance, before the sixth medical consultation. Among the reasons for the doctor following the abandonment of the follow-up service, there were more reasons regarding the absence of symptoms (and distance from home). The absence of symptoms and distance from the capital were associated with the abandonment of outpatient treatment of anoxic children. Outpatient services should be organized to minimize the follow-up abandon situations. Keywords: Ambulatory Care. Asphyxia Neonatorum. Health Planning. ResumoAsfixia perinatal é uma das principais causas de lesão cerebral evitável. Cerca de quatro a nove milhões de recém-nascidos desenvolvem asfixia ao nascer. Estima-se que 1,2 milhão evoluem para óbito e desenvolvem sequelas neurológicas incapacitantes. Essas crianças precisam ser acompanhadas por especialistas, principalmente no primeiro ano de vida. A continuidade da assistência após a alta hospitalar deve ser garantida para que haja seguimento do cuidado aos que apresentam maior risco de morbimortalidade. Identificar fatores associados ao abandono do tratamento ambulatorial especializado de crianças diagnosticadas com asfixia perinatal. Estudo desenvolvido no ambulatório de assistência neonatal de uma maternidade referência para partos de alto risco no estado de Sergipe. Participaram do estudo 98 crianças anoxiadas egressas da Unidade de Terapia Intensiva Neonatal dessa maternidade. As crianças acompanhadas tinham entre dois meses a dois anos, predominantemente do sexo masculino 69. Dez crianças receberam alta por idade aos 24 meses, apresentando sequelas neurológicas importantes. Trinta e uma crianças receberam alta entre 10 a 20 meses sem déficit e 35 mantiveram-se em acompanhamento regular. Houve o registro de 22 casos de abandono do tratamento, antes da sexta consulta médica. Entre os motivos para o abandono do seguimento no serviço de follow-up, predominaram a ausência de sintomas e a distância do domicílio. A ausência de sintomas e a distância da capital estiveram associadas ao abandono de tratamento ambulatorial de crianças anoxiadas. Os serviços ambulatoriais devem estar organizados para minimizar situações de abandono do seguimento. Palavras-chave: Assistência Ambulatorial. Asfixia Neonatal. Planejamento em Saúde.

scholarly journals The impact of volume overload on technique failure in incident peritoneal dialysis patients

2019 ◽  
Author(s):  
François Vrtovsnik ◽  
Christian Verger ◽  
Wim Van Biesen ◽  
Stanley Fan ◽  
Sug-Kyun Shin ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Risk Model ◽  
Volume Overload ◽  
Competing Risk ◽  
Related Factors ◽  
Time Points ◽  
Increased Risk ◽  
The Impact ◽  
Technique Failure

Abstract Background Technique failure in peritoneal dialysis (PD) can be due to patient- and procedure-related factors. With this analysis, we investigated the association of volume overload at the start and during the early phase of PD and technique failure. Methods In this observational, international cohort study with longitudinal follow-up of incident PD patients, technique failure was defined as either transfer to haemodialysis or death, and transplantation was considered as a competing risk. We explored parameters at baseline or within the first 6 months and the association with technique failure between 6 and 18 months, using a competing risk model. Results Out of 1092 patients of the complete cohort, 719 met specific inclusion and exclusion criteria for this analysis. Being volume overloaded, either at baseline or Month 6, or at both time points, was associated with an increased risk of technique failure compared with the patient group that was euvolaemic at both time points. Undergoing treatment at a centre with a high proportion of PD patients was associated with a lower risk of technique failure. Conclusions Volume overload at start of PD and/or at 6 months was associated with a higher risk of technique failure in the subsequent year. The risk was modified by centre characteristics, which varied among regions.

scholarly journals Factors associated with being lost to follow-up before completing tuberculosis treatment: analysis of surveillance data

2012 ◽  
Vol 141 (6) ◽  
pp. 1223-1231 ◽  
Author(s):  
E. R. C. MILLETT ◽  
D. NOEL ◽  
P. MANGTANI ◽  
I. ABUBAKAR ◽  
M. E. KRUIJSHAAR
Keyword(s):  
Surveillance Data ◽  
Sputum Smear ◽  
Tuberculosis Patients ◽  
Factors Associated ◽  
Increased Risk ◽  
Patients At Risk ◽  
Treatment Analysis ◽  
The Uk ◽  
Lost To Follow Up

SUMMARYCompletion of treatment is key to tuberculosis control. Using national surveillance data we assessed factors associated with tuberculosis patients being lost to follow-up before completing treatment (‘lost’). Patients reported in England, Wales and Northern Ireland between 2001 and 2007 who were lost 12 months after beginning treatment were compared to those who completed, or were still on treatment, using univariable and multivariable logistic regression. Of 41 120 patients, men [adjusted odds ratio (aOR) 1·29; 95% confidence interval (CI) 1·23–1·35], 15- to 44-year-olds (P<0·001), and patients with pulmonary sputum smear-positive disease (aOR 1·25, 95% CI 1·12–1·45) were at higher risk of being lost. Those recently arrived in the UK were also at increased risk, particularly those of the White ethnic group (aOR 6·39, 95% CI 4·46–9·14). Finally, lost patients had a higher risk of drug resistance (aOR 1·41, 95% CI 1·17–1·69). Patients at risk of being lost require enhanced case management and novel case retention methods are needed to prevent this group contributing towards onward transmission.

scholarly journals Impact of Mobile Health Devices for the Detection of Atrial Fibrillation: Systematic Review

10.2196/26161 ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. e26161
Author(s):  
Tom E Biersteker ◽  
Martin J Schalij ◽  
Roderick W Treskes
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Mobile Health ◽  
Standard Care ◽  
Detection Rate ◽  
Increased Risk ◽  
Study Results ◽  
Statistical Heterogeneity ◽  
Study Participants

Background Atrial fibrillation (AF) is the most common arrhythmia, and its prevalence is increasing. Early diagnosis is important to reduce the risk of stroke. Mobile health (mHealth) devices, such as single-lead electrocardiogram (ECG) devices, have been introduced to the worldwide consumer market over the past decade. Recent studies have assessed the usability of these devices for detection of AF, but it remains unclear if the use of mHealth devices leads to a higher AF detection rate. Objective The goal of the research was to conduct a systematic review of the diagnostic detection rate of AF by mHealth devices compared with traditional outpatient follow-up. Study participants were aged 16 years or older and had an increased risk for an arrhythmia and an indication for ECG follow-up—for instance, after catheter ablation or presentation to the emergency department with palpitations or (near) syncope. The intervention was the use of an mHealth device, defined as a novel device for the diagnosis of rhythm disturbances, either a handheld electronic device or a patch-like device worn on the patient’s chest. Control was standard (traditional) outpatient care, defined as follow-up via general practitioner or regular outpatient clinic visits with a standard 12-lead ECG or Holter monitoring. The main outcome measures were the odds ratio (OR) of AF detection rates. Methods Two reviewers screened the search results, extracted data, and performed a risk of bias assessment. A heterogeneity analysis was performed, forest plot made to summarize the results of the individual studies, and albatross plot made to allow the P values to be interpreted in the context of the study sample size. Results A total of 3384 articles were identified after a database search, and 14 studies with a 4617 study participants were selected. All studies but one showed a higher AF detection rate in the mHealth group compared with the control group (OR 1.00-35.71), with all RCTs showing statistically significant increases of AF detection (OR 1.54-19.16). Statistical heterogeneity between studies was considerable, with a Q of 34.1 and an I2 of 61.9, and therefore it was decided to not pool the results into a meta-analysis. Conclusions Although the results of 13 of 14 studies support the effectiveness of mHealth interventions compared with standard care, study results could not be pooled due to considerable clinical and statistical heterogeneity. However, smartphone-connectable ECG devices provide patients with the ability to document a rhythm disturbance more easily than with standard care, which may increase empowerment and engagement with regard to their illness. Clinicians must beware of overdiagnosis of AF, as it is not yet clear when an mHealth-detected episode of AF must be deemed significant.

scholarly journals Maternal Risk Factors Associated with Poor Postpartum Healthcare Utilization

2020 ◽  
Author(s):  
michael e silverman ◽  
Holly Loudon ◽  
Laudy Burgos
Keyword(s):  
Mount Sinai Hospital ◽  
Population Based ◽  
Postpartum Care ◽  
Related Factors ◽  
Maternal Risk ◽  
Factors Associated ◽  
Ambulatory Practice ◽  
Mount Sinai ◽  
Prenatal Visits

Abstract Objectives: Perceptions regarding the benefits of postpartum care among mothers and clinicians often differ. Clinicians generally perceive postpartum care as preventative, whereas pregnant and postpartum women often lack knowledge about its preventative benefits. As a result many women choose not to return for scheduled postpartum care visits. Methods: To examine if clinically relevant demographic and birth related factors are informative predictors for postpartum healthcare follow-up care, we conducted a population based cohort study of all women who delivered a child in 2012 – 2015 at the New York Mount Sinai Hospital Obstetrics and Gynecology Ambulatory Practice. Data was ascertained from electronic health records.Results: Of the 4,240 unique women who delivered between 2012-2015 at the Mount Sinai Hospital OB/GYN Ambulatory Practice, 1,685 (39.7%) did not return for their postpartum care follow-up appointment. The number of prenatal visits, maternal age, and parity were significantly associated with postpartum care follow-up. Conclusion for Practice: The purpose of this study was to determine identifiable factors associated with reduced postpartum healthcare follow-up utilization. Several clinically relevant variables were associated with the reduced likelihood for attending postpartum care visits. Because pregnant women represent a medically captured population, the results of this study point to the need to increase postpartum healthcare literacy during perinatal appointments especially among younger mothers, women who have had previous deliveries, and those with fewer prenatal visits.

Neurodevelopmental Outcomes after Neonatal Mechanical Ventilation

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Eman Ahmed Zaky ◽  
Hebatallah AM Shaaban ◽  
Mohamed OA Dawoud ◽  
Kareem SEF Madbouly ◽  
Shaymaa M Deifalla
Keyword(s):  
Mechanical Ventilation ◽  
Rating Scale ◽  
Neurodevelopmental Outcomes ◽  
Neurodevelopmental Delay ◽  
Increased Risk ◽  
Study Results ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Significant Difference

Abstract Background A majority of extremely preterm infants are treated with mechanical ventilation, which is associated with an increased risk for future development of chronic lung disease, neonatal brain damage, and neurodevelopmental impairments. Objectives The aim of the current study was to evaluate the current and follow up neurodevelopmental status of an Egyptian sample of newly and previously discharged mechanically ventilated infants following them up for a period of 6 months for the earlier group and a year for the latter. Patients and Methods The current study was designed to be a descriptive study with retrospective (50 infants) and prospective (50 infants) domains. It was carried out on 100 neonates who were recruited from the Pediatric Neonatology Clinic, Children's Hospital and Neonatal Intensive Care Unit, Ain Shams University using clinical evaluation, Bayley Scales of Infant Development, and Childhood Autism Rating Scale (CARS).. Results There was statistically significant negative correlation between CARS score and Bayley Scale by using Composite Score (Cognitive, Language and Motor) on first assessment and follow up in the Prospective group while no correlation was found in the retrospective group. The study results showed that there was no statistical significant difference between two groups as regards gestational age, gender, residency, consanguinity, maternal disease, maturity, mode of delivery, respiratory distress, duration of stay in NICU, duration on mechanical ventilation, weight on admission, audiometry and fundus examination (P &gt; 0.05). Conclusion Using a mechanical ventilator in the neonatal period for a prolonged duration increased the risk for ASD and neurodevelopmental delay. Future studies on large samples are recommended from multicenters to confirm the validity of such findings, Bayley scale is a predicative for neurodevelopmental delay in neonates with long duration stay at NICU especially preterms with low birth weight.

scholarly journals 717. Cumulative Incidence of Asthma/Wheezing Among Neonates/Infants/Toddlers Clinically Diagnosed with Respiratory Syncytial Virus Infection in the United States: A Retrospective Database Analysis

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S257-S258
Author(s):  
Veronique Wyffels ◽  
Maartje Smulders ◽  
Sandra Gavart ◽  
Debasish Mazumder ◽  
Rohit Tyagi ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Respiratory Syncytial Virus ◽  
Cumulative Incidence ◽  
The United States ◽  
Term Infants ◽  
Increased Risk ◽  
Study Results ◽  
Syncytial Virus ◽  
Time Required

Abstract Background The role of respiratory syncytial virus (RSV) in the development of asthma/wheezing (AW) has been evaluated in several studies, mostly among pre-term infants or among infants after developing severe RSV-related disease. We describe the cumulative incidence (CI) of AW among hospitalized/ambulatory neonates/infants/toddlers after RSV/bronchiolitis infection diagnosis, in a large clinical database. Methods Using deidentified Optum Integrated commercial claims and electronic medical records, we identified patients (0–&lt;3 years old) with a first clinical diagnosis of RSV/bronchiolitis infection from 01 January 2008–31 March 2016. Patients with a diagnosis of asthma/wheezing ≤30 days after first RSV/bronchiolitis diagnosis were excluded. Three cohorts were created with 1/3/5 years of follow-up time required, respectively. Patients were grouped by specific high-risk factors (HRF+/−), including pre-term births and predefined pre-existing disease. Descriptive statistics are reported, with comparisons made by logistic regression analyses. Results 9,811/4,524/1,788 patients with RSV/bronchiolitis infection and HRF− were included in the 1/3/5-years follow-up cohorts. 14.9%/28.2%/36.3% had AW events by the end of follow-up in the three cohorts. 6.5%/6.9%/5.8% were hospitalized for RSV/bronchiolitis. 3,030/1,378/552 patients with RSV/bronchiolitis infection and HRF+ were included in the 1/3/5-years follow-up cohorts. 18.1%/32.9%/37.9% had AW events by the end of follow-up in the three cohorts. 11.4%/11.1%/11.6% were hospitalized for RSV/bronchiolitis. The CI rates of AW in the 1/3/5-year HRF+/− cohorts, stratified by hospitalized for RSV/bronchiolitis Y/N, are shown in Figure 1. Logistic regression confirmed that hospitalization for RSV/bronchiolitis was associated with an increased (P &lt; 0.05) likelihood of AW, for HRF+ and HRF− patients at each follow-up year. Conclusion Thirty-eight percent of RSV/bronchiolitis infants/neonates/toddlers HRF+, and 36% among infants/neonates/toddlers HRF−, developed AW in the 5 years after first RSV/bronchiolitis diagnosis. RSV/bronchiolitis hospitalization was associated with a significantly increased risk of AW development in 1/3/5 years of follow-up; confirming previous observational study results. Disclosures V. Wyffels, Janssen: Employee, Salary. M. Smulders, SmaertAnalyst: Consultant, Consulting fee. S. Gavart, Janssen: Employee, Salary. D. Mazumder, SmartAnalyst: Consultant, Consulting fee. R. Tyagi, SmartAnalyst: Consultant, Consulting fee. N. Gupta, SmartAnalyst: Consultant, Consulting fee. R. Fleischhackl, Janssen: Employee, Salary.

P5341Predictive factors of atherosclerotic cardiovascular diseases events in HIV-HVC co-infected patients: results from hepavih ANRS co13 cohort

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F Boccara ◽  
B K Tan ◽  
M Chalouni ◽  
D Salmon Ceron ◽  
A Cinaud ◽  
...  
Keyword(s):  
Viral Load ◽  
Sustained Viral Response ◽  
Biological Data ◽  
Personal History ◽  
Hiv Viral Load ◽  
Factors Associated ◽  
Coronary Syndrome ◽  
Increased Risk ◽  
History Of

Abstract Introduction Several studies highlighted an increased risk of cardiovascular disease (CVD) in HIV-HCV co-infected patients without clearly identifying specific virologic factors associated with atherosclerotic CVD (ASCVD) events. Purpose Hence, we analyzed data collection from the French nationwide ANRS CO13 HEPAVIH cohort to determine the incidence of ASCVD events in HIV-HCV co-infected patients and the predictive factors associated with its occurrence. Methods The French multicenter nationwide ANRS CO13 HEPAVIH clinic-based cohort collected prospective clinical and biological data from HIV-HCV co-infected patients followed-up in 28 different university hospitals between December 2005 to November 2016. Participants with at least one year of follow-up were included. Primary outcome was the occurrence of major ASCVD events (cardiovascular death, acute coronary syndrome, coronary revascularization and stroke). Secondary outcomes were total ASCVD events including major ASCVD events and minor ASCVD events (peripheral arterial disease [PAD]). Incidence rates were estimated using Aalen-Johansen method and factors associated with ASCVD identified with Cox proportional hazards models. Results A total of 1213 patients were included: median age 45.4 years [42.1–49.0], 70.3% men, current smoking 70.2%, overweight 19.5%, liver cirrhosis 18.9%, chronic alcohol consumption 7.8%, diabetes mellitus (5.9%), personal history of CVD 2.7%, and statins use 4.1%. After a median follow-up of 5.1 years [3.9–7.0], 44 participants experienced at least one ASCVD event (26 major ASCVD event, and 20 a minor event). Incidences for total, major and minor ASCVD events were of 6.98 [5.19; 9.38], 4.01 [2.78; 6.00], and 3.17 [2.05; 4.92] per 1000 person-years, respectively. Personal history of CVD (Hazard Ratio (HR)=13.94 [4.25–45.66]), high total cholesterol (HR=1.63 [1.24–2.15]), low HDL cholesterol (HR=0.08 [0.02–0.34]) and undetectable HIV viral load (HR=0.41 [0.18–0.96]) were identified as independent factors associated with major ASCVD events while cirrhosis status, liver fibrosis and HCV sustained viral response were not. Cumulative incidence of CV events Conclusion HIV-HCV co-infected patients experience a high incidence of ASCVD events both coronary and peripheral artery diseases. Traditional CV risk factors are the main determinants of ASCVD whereas undetectable HIV viral load seems to be protective. Management of cholesterol abnormalities and controlling viral load are essential to modify this high cardiovascular risk. Acknowledgement/Funding Agence Natoinale de Recherche sur le SIDA et les Hépatites virales

scholarly journals Prospective Analysis of Prevalence, Trajectories of Change, and Correlates of Cannabis Misuse in Older Adolescents from Coastal Touristic Regions in Croatia

2019 ◽  
Vol 16 (16) ◽  
pp. 2924
Author(s):  
Lejla Obradovic Salcin ◽  
Vesna Miljanovic Damjanovic ◽  
Anamarija Jurcev Savicevic ◽  
Divo Ban ◽  
Natasa Zenic
Keyword(s):  
Rural Communities ◽  
Social Status ◽  
Maternal Education ◽  
Drug Misuse ◽  
Protective Effects ◽  
Related Factors ◽  
Adult Supervision ◽  
Increased Risk ◽  
Cannabis Consumption

The prevalence of illicit drug misuse, including cannabis, in Croatian touristic regions is alarming. This study aimed to identify the prevalence of cannabis consumption (CC), to identify associations between sociodemographic and sport factors and CC, and to evaluate the predictors of CC initiation in adolescents residing in touristic regions. This study enrolled 644 adolescents from two touristic regions in Croatia (Split-Dalmatia and Dubrovnik-Neretva County) who were tested at baseline (16 years of age) and follow-up (18 years of age). The study instrument consisted of questions focused on predictors (age, gender (male, female), place of residence (urban or rural environment), familial social status, and different sport-related factors) and CC outcome. The results indicated a high prevalence of cannabis consumption (>30% of adolescents consumed cannabis), with a higher prevalence in males, and adolescents from rural communities. The prevalence of CC increased by 10% during the study period, with no significant differences between genders in trajectories of changes. Quitting sports was a risk factor for CC at baseline and follow-up. Better sport competitive results (odds ratio (OR): 0.80, 95% confidence interval (CI): 0.65–0.96) and familial social status (socioeconomic status: OR: 0.66, 95% CI: 0.39–0.91; maternal education: OR: 0.65, 95% CI: 0.48–0.88) were associated with lower likelihood of CC at baseline. The adolescents who reported better sport competitive results were at increased risk for initiation of CC during the course of the study (OR: 1.40, 95% CI: 1.03–2.01). The protective effects of sports at baseline were most likely related to various factors that prevent the consumption of substances in youth athletes (i.e., commitment to results, adult supervision); with the end of active participation, adolescent athletes are at high risk for CC initiation.

A Systematic Literature Review and Meta-Analysis of the Risk of Thromboembolic Events in Patients with Immune Thrombocytopenia (ITP) in Observational Studies.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2187-2187 ◽  
Author(s):  
Wendy Langeberg ◽  
Melissa Eisen ◽  
W. Marieke Schoonen ◽  
Laurence Gamelin ◽  
Scott Stryker
Keyword(s):  
Relative Risk ◽  
Observational Studies ◽  
Immune Thrombocytopenia ◽  
Meta Analysis ◽  
Employment Equity ◽  
Effect Model ◽  
Increased Risk ◽  
Study Results ◽  
Equity Ownership

Abstract Abstract 2187 Introduction: A recent systematic review and meta-analysis of randomized controlled trials of thrombopoietin-receptor agonists (TPOr), romiplostim and eltrombopag, in adult thrombocytopenic patients found a numerically but non-statistically significant increase in the occurrence of thromboembolism (TE) among treated patients compared to those not treated with TPOr.1 To put these results into context and to estimate the baseline risk of TE in ITP patients, this study will summarize results of observational studies that reported the risk of venous thrombembolism (VTE) or arterial thrombembolism (ATE) in patients with ITP relative to comparable populations without ITP. Methods: We searched MEDLINE and EMBASE via Ovid and the Cochrane database for articles that included both terms relating to ITP (i.e., immune thrombocytopenia, idiopathic thrombocytopenia) and TE (i.e., thromboembolism, thrombosis, embolism). Articles were restricted to research on humans, published in English, January 1996 to July 2012. Only observational studies were included. We abstracted measures of relative risk (or rate ratio) comparing the incidence of TE in ITP patients with that in a comparable non-ITP population. The pooled relative risk and 95% confidence intervals (CIs) were calculated by taking a weighted average of individual study results using both fixed and random effects models using the META2 module for STATA 10. Results: Five observational studies met the inclusion criteria: two from Denmark and one each from Sweden, United Kingdom, and United States; all published 2010–2012. All studies completed patient follow-up before the commercial availability of TPOr. Studies varied in the duration of follow-up, choice of comparison group, and specific events reported. Some studies excluded patients with previous events. The relative risk of any VTE among patients with ITP compared to that in a non-ITP population ranged from 1.6 to 2.9 based on 3 studies that reported VTE. The pooled relative risk of any VTE was 1.9 (95%CI 1.4, 2.7) using a fixed-effect model and similar estimates using a random effect model (test for heterogeneity, p = 0.3). The relative risk of any ATE among patients with ITP compared to that in a non-ITP population ranged from 1.3 to 1.6 based on 3 studies that reported ATE. The pooled relative risk of any ATE was 1.5 (95%CI 1.3, 1.8) for both the random and fixed effects models (test for heterogeneity, p = 0.7). Conclusions: Five population-based observational studies have been published recently comparing the risk of thrombembolism among ITP patients to populations without ITP. The results of a meta-analysis showed nearly a 2-fold increased risk of VTE and a 50% increased risk of ATE among the general population of ITP patients not treated with TPOr. These ITP patients were likely to have less severe disease than those in experimental trials where entrance criteria may require significant thrombocytopenia, prior bleeding episodes, or failure of a previous therapy. However, the demonstrated elevated risk of TE among patients with ITP should be considered when evaluating the risk of TE ascribed to ITP treatments. Disclosures: Langeberg: Amgen: Employment, Equity Ownership. Eisen:Amgen: Employment, Equity Ownership. Schoonen:Amgen: Employment, Equity Ownership. Gamelin:Amgen: Employment, Equity Ownership. Stryker:Amgen: Employment, Equity Ownership.

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