De-identified Information Research Articles

Research using electronic health records: Balancing confidentiality and public good.

General practitioners are increasingly approached to participate in research and share de-identified patient information. Research using electronic health records has considerable potential for improving the quality and safety of patient care. Obtaining individual patient consent for the use of the information is usually not feasible. In this article we explore the ethical issues in using personal health information in research without patient consent including the threat to confidentially and the doctor-patient relationship, and we discuss how the risks can be minimised and managed drawing on our experience as general practitioners and researchers.

Trichomonas vaginalis and Chlamydia trachomatis co-infections

Trichomonas vaginalis and Chlamydia trachomatis co-infections

OP08 Using Real World Data To Support National Postmarketing Surveillance

Introduction:While medicines and medical tests are developed in a controlled clinical trial environment, postmarketing surveillance in the real world can be challenging. MedicineInsight—a database of longitudinal patient-level clinical information from primary care practices in Australia—is a novel program that collects primary care data to improve postmarketing surveillance at a national level.Methods:MedicineInsight collects de-identified clinical information from primary care practice information systems using data extraction tools. MedicineInsight currently includes 3.6 million regular patients of 3,300 family physicians (general practitioners) from 650 primary care practices across Australia. MedicineInsight data include longitudinal clinical information on diagnosis and medicines (dose, strength, route of administration, medication switches over time, adverse events, and allergies), and pathology testing data. A series of observational studies was developed for postmarketing surveillance of management of a range of health priorities including type 2 diabetes mellitus (T2DM), chronic obstructive pulmonary disease (COPD), depression, and antibiotics use.Results:Forty-four percent of patients with T2DM in the MedicineInsight database did not have a recorded hemoglobin A1c result and thirty-one percent did not have a recorded blood pressure reading in the previous 6 months. While guidelines recommend a stepwise approach to the initiation of COPD therapy, forty-nine percent of patients with COPD (with or without asthma) were prescribed dual therapy at initiation and a small number (4.5 percent) were prescribed triple therapy. Between 2011 and 2015, the annual rate of antidepressant prescribing per 1,000 family physician encounters increased by eight percent. High volumes of antibiotics were prescribed for respiratory tract infections in Australian primary care, notwithstanding guideline recommendations that antibiotics are not recommended in most cases.Conclusions:Large scale, real-world clinical data from primary care practices can play an important role in postmarketing surveillance at a national level.

Incidence of Thromboembolic Events Is Increased in a Retrospective Analysis of a Large Cold Agglutinin Disease (CAD) Cohort

Introduction: Cold agglutinin disease (CAD) is a rare form of autoimmune hemolytic anemia (AIHA) with a prevalence of approximately 16 patients per million. CAD accounts for less than 20% of all AIHA and is characterized by immunoglobulin M (IgM) mediated agglutination of erythrocytes and subsequent activation of the classical complement pathway. In addition to hemolysis, which can vary from mild to severe, clinical manifestations of CAD have been reported to include livedo reticularis, acrocyanosis, circulatory symptoms and cutaneous necrosis (Swiecicki, P Et al Blood 2013). The rarity of this disease has resulted in a lack of data regarding its natural history. Thromboembolic events (TEs) are a known complication of other hemolytic disorders, however, little is known about its incidence and severity in CAD. We evaluated the largest cohort of CAD patients to date and compared them to a matched non-CAD cohort to evaluate clinical characteristics and occurrence rate of TEs.Methods: Patients were identified from the Optum-Humedica database, containing de-identified information on claims, medications, lab results, diagnoses, procedures and clinical notes for individuals from all 50 states. The presence of “cold agglutinin disease” must have appeared in their medical record on at least 3 separate dates from 2006-2016. Patients with “cold agglutinin disease” documented on 1 or 2 dates were included only after an independent review and agreement by 2 hematologists. A comparison cohort was identified from the database and matched on gender, race, region, overall follow-up time, age, and entry date into the health plan. Patient characteristics, TEs, treatment with rituximab, and lab parameters [hemoglobin (Hgb), bilirubin, lactate dehydrogenase (LDH)] were evaluated. LDH and bilirubin were included as they represent hemolysis and indirect measures of complement activity in CAD. TEs in both cohorts were identified from claims submitted.Results: 814 patients with CAD and 7,960 comparisons were identified. Median follow-up time for CAD patients was 75.6 months (0-125 months). Seventy percent of CAD patients were over 65 years of age, 62% were women and 84% were Caucasian. Forty-four percent of CAD patients reside in the midwest, 13% in the northeast, 29% in the south, 12% in the west, with 2% unknown.Thirty-one percent of CAD patients had a medical claim for any form of TE compared to 20% in the matched comparisons (p < 0.0001). Eighteen percent of CAD patients had 1 TE compared to 14% of the matched comparisons (p < 0.001). Thirteen percent of CAD patients had 2 or more types of TEs compared to 6% of matched comparisons (p < 0.001). Nearly 10% of all CAD patients had a venous TE compared to 3% of matched comparisons (p < 0.0001). Twenty five percent of all CAD patients had a cerebral TE compared to 16% of matched comparisons (p < 0.0001). Eight percent of all CAD patients had an arterial TE compared to 5% of matched comparisons (p < 0.0001).Of the 94 CAD patients that had available Hgb within a month prior to a medical claim for a TE, 47% had mild anemia (Hgb > 10 g/dL), 29% had moderate anemia (Hgb 8.1-10 g/dL) and 24% had severe anemia (Hgb < 8 g/dL). Forty-one of the 94 patients had LDH and bilirubin values documented within one month of a medical claim for TE. Ninety percent of these CAD patients had evidence of ongoing hemolysis, represented by an abnormal bilirubin or LDH.Seventy-nine percent of CAD patients treated with a rituximab-containing regimen had an abnormal bilirubin or LDH within 12 months of completion of therapy.Conclusion: Thromboembolic events have been an under-appreciated complication of CAD. Patients with CAD had a significantly higher overall incidence of TEs compared to matched comparisons including venous, arterial, and cerebral events. Furthermore, patients with CAD also had a higher incidence of more than one type of TE. The severity of anemia does not appear to predict TE risk, whereas markers of hemolysis (LDH/bilirubin) do. Standard therapy with rituximab did not result in sustained control of hemolysis, as demonstrated by abnormal bilirubin and LDH values in a majority of patients within 12 months of last dose. Therapeutic modalities that can quickly and completely inhibit complement activity in CAD may offer clinical benefits beyond correcting hemolysis and anemia, such as decreasing TE risk.Disclosures: This study was funded by True North Therapeutics, Inc., a Bioverativ Inc. company DisclosuresBroome:TrueNorth Therapuetics: Honoraria; Alexion Pharmaceuticals: Honoraria. Cunningham:TrueNorth therapeutics: Honoraria. Rosenthal:Bioverativ Inc: Employment.

Ask and You Might Not Receive: How FERPA’s Disclosure Provisions Can Affect Educational Research

The Family Educational Rights and Privacy Act (FERPA) regulates how schools collect, use, and disclose student information, including disclosures to third-party educational researchers. This article examines how educational researchers can structure their activities to reduce the risk of violating FERPA’s disclosure restrictions. In order to do so, we present two options for researchers to consider: utilizing de-identified student information that does not fall within the scope of FERPA, or complying with FERPA by securing prior consent for student information disclosure or qualifying for an exception from FERPA’s consent requirement. The article’s discussion of these options includes an overview of FERPA’s legal framework, along with the practical advantages and disadvantages of each option.

Access to specialist palliative care services by people with severe and persistent mental illness: A retrospective cohort study.

Compared to the general population, people with pre-existing serious and persistent mental illness (SPMI) have higher rates of physical illness and die at an earlier age, raising questions about their palliative and end-of-life care needs when they are diagnosed with an incurable physical illness. In the present study, we explored access to specialist palliative care services within one New Zealand health district. Routinely-collected, de-identified patient information on a cohort of people diagnosed with SPMI, and receiving specialist palliative care services from the Capital and Coast District Health Board (CCDHB), was compared to the general population from the same health district. People with SPMI are 3.5 times less likely to receive specialist palliative services compared to the general population from the Capital and Coast District Health Board. The proportion of people identifying as Māori is 1.2 times higher in the SPMI cohort than the general CCDHB population. The SPMI cohort experiences a higher level of deprivation compared to the general population in the CCDHB. The present study confirms that those diagnosed with an SPMI are less likely to use specialist palliative care services at the end of life. Research using a national dataset is needed to determine whether the study findings are applicable to the national population.

Patient Consent and the Commercialization of Lab Data.

Every year, commercial testing labs earn millions of dollars from selling the anonymized results of blood, urine, tissue, and other tests with almost no public scrutiny or debate.2 Few outside the industry know anything about this trade, and lab workers are often in the dark as well. When I tell people about the growing commercial trade in anonymized patient data from sources including electronic health records, insurance claims data, and prescriptions, the sale of lab data from companies such as Quest and LabCorp sparks the greatest surprise and concern. Discussing the secondary use of data unrelated to the direct treatment of the tested patient also makes labs and their data mining clients uneasy. Many prefer to avoid any substantive discussion of the tradeoffs between advancing scientific knowledge by sharing data and protecting patient privacy. LabCorp provides a good example of such reticence. I unsuccessfully tried to contact LabCorp's CEO three times in 2015 while researching my latest book (1) and another two times in 2016 for this article.3 When asked whether LabCorp shares anonymized data with outside companies, and, if so, under what circumstances, privacy officer Don Luu responded: “LabCorp would disclose de-identifiable information to business associates for various purposes related to its business and operations.”4 After I asked for more clarity Luu acknowledged such trade: “LabCorp would share de-identified information outside of its organization as it is permitted by the HIPAA Rules.”5 I wrote LabCorp again regarding this article in Clinical Chemistry , and it took a few weeks to receive written responses from the company's chief information officer Lance Berberian. “The use of de-identified and aggregated patient data is a long-standing, widely acknowledged practice that leads to better patient outcomes,” he wrote. “That data includes information derived from diagnostic results (including laboratory tests), prescribing …

Getting Data Sharing Right to Help Fulfill the Promise of Cancer Genomics

Limited access to the profusion of sequence information derived from cancer patients worldwide stymies basic research and clinical decisions. Efforts are underway to streamline and safeguard data use.

Clinical genomics, big data, and electronic medical records: reconciling patient rights with research when privacy and science collide.

Widespread use of medical records for research, without consent, attracts little scrutiny compared to biospecimen research, where concerns about genomic privacy prompted recent federal proposals to mandate consent. This paper explores an important consequence of the proliferation of electronic health records (EHRs) in this permissive atmosphere: with the advent of clinical gene sequencing, EHR-based secondary research poses genetic privacy risks akin to those of biospecimen research, yet regulators still permit researchers to call gene sequence data ‘de-identified’, removing such data from the protection of the federal Privacy Rule and federal human subjects regulations. Medical centers and other providers seeking to offer genomic ‘personalized medicine’ now confront the problem of governing the secondary use of clinical genomic data as privacy risks escalate. We argue that regulators should no longer permit HIPAA-covered entities to treat dense genomic data as de-identified health information. Even with this step, the Privacy Rule would still permit disclosure of clinical genomic data for research, without consent, under a data use agreement, so we also urge that providers give patients specific notice before disclosing clinical genomic data for research, permitting (where possible) some degree of choice and control. To aid providers who offer clinical gene sequencing, we suggest both general approaches and specific actions to reconcile patients’ rights and interests with genomic research.

Autonomic Nervous System Dysfunctions as a Basis for a Predictive Model of Risk ofNeurological Disorders in Subjects withPrior History of Traumatic Brain Injury: Implications in Alzheimer's Disease.

Autonomic dysfunction is very common in patients with dementia, and its presence might also help in differential diagnosis among dementia subtypes. Various central nervous system structures affected in Alzheimer's disease (AD) are also implicated in the central autonomic nervous system (ANS) regulation. For example, deficits in central cholinergic function in AD could likely lead to autonomic dysfunction. We recently developed a simple, readily applicable evaluation for monitoring ANS disturbances in response to traumatic brain injury (TBI). This ability to monitor TBI allows for the possible detection and targeted prevention of long-term, detrimental brain responses caused by TBI that lead to neurodegenerative diseases such as AD. We randomly selected and extracted de-identified medical record information from subjects who have been assessed using the ANS evaluation protocol. Using machine learning strategies in the analysis of information from individual as well as a combination of ANS evaluation protocol components, we identified a novel prediction model that is effective in correctly segregating between cases with or without a documented history of TBI exposure. Results from our study support the hypothesis that trauma-induced ANS dysfunctions may contribute to clinical TBI features. Because autonomic dysfunction is very common in AD patients it is possible that TBI may also contribute to AD and/or other forms of dementia through these novel mechanisms. This study provides a novel prediction model to physiologically assess the likelihood of subjects with prior history of TBI to develop clinical TBI complications, such as AD.

Effect of Red Blood Cell Transfusions on Clinical Outcomes in Critically Ill Children

▪Introduction: The association of packed Red Blood Cell (pRBC) transfusions with worse outcomes in critically ill adults is well documented. The impact of pRBC transfusions on clinical outcomes in critically ill children, however, has not been well studied. Associations of pRBCs with outcomes such as mortality and length of stay need to be studied in large clinical databases. This will lead to improvement of our knowledge and generation of guidelines for transfusions in children hospitalized in the Pediatric Intensive Care Units (PICU).Methods: With IRB approval, the Pediatric Health Information System (PHIS) database was queried for children ≤ 18 years admitted to the PICU, receiving pRBC transfusions between January 2011 and December 2015. The PHIS is a database that captures de-identified patient information from 45 pediatric hospitals in the US. The patients of this study were stratified by age groups: less than 1 month of age; 1 month to < 3years; 3 to <10 years; 10 to < 15 years and 15 to 18 years. Patients with underlying hematological or oncological diagnoses and who had undergone HSCT were excluded from the study. Information regarding major comorbidities such as mechanical ventilation, sepsis, use of vasoactive agents, acute kidney injury (AKI) and post-operative state were extracted. Patients who received pRBCs and who did not receive pRBCs were included in the analyses. The primary outcomes were Length of Stay (LOS) and mortality. Multiple linear and logistic regression analyses were performed to define the association between pRBC transfusions and outcomes and to control for sepsis, mechanical ventilation, vasoactive medications, post-operative state and AKI. Data are shown as median (IQR).Results: Of the 393,384 patients who met the inclusion criteria, 43,569 (11%) had transfusions, with 97.2% of the patients receiving only 1 transfusion. The median (IQR) overall length of stay was 5.0 days (2, 10) and the overall mortality was 3.1%. The median (IQR) LOS for those who received pRBCs was 13 days (6, 29) compared to 4.0 days (2, 8) for those who did not. Mortality for those who received pRBCs was 10.1% compared to 2.2% for those who did not. The highest rate of pRBC transfusion was noted in the patients less than 1 month old (22%). The highest unadjusted mortality for patients who received pRBCs was also in the same age group- 7%.The associations between transfusion of pRBCs and outcomes are summarized in Table 1. Of the 393,384 patients, 19,686 (5.0 %) had sepsis; 143,085 (36.4%) were on mechanical ventilation; 141,123 (35.9%) were on vasoactive agents and 14,243 (3.6%) had AKI. After adjusting for sepsis, mechanical ventilation, use of vasoactive agents, post-op state and AKI, pRBC transfusions were associated with significantly increased LOS for all age groups. The highest increase in LOS was noted for the infants younger than 1 month of age - by 11.6 days (p<0.001). The mortality was also increased in patients who received PRBCs, when adjusted for other comorbidites, the highest risk was for patients in the age group of 15 to 18 years old: OR 2.50 (95% CI 2.14- 2.93).Conclusions: In this large, multicenter database study, we identified an association of increased mortality and LOS in critically ill children who received pRBC transfusions. More studies are needed to further investigate the impact of blood transfusions on clinical outcomes in the pediatric population. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Research Registries: A Tool to Advance Understanding of Rare Neuro-Ophthalmic Diseases.

Medical research registries (MRR) are organized systems used to collect, store, and analyze patient information. They are important tools for medical research with particular application to the study of rare diseases, including those seen in neuro-ophthalmic practice. Evidence for this review was gathered from the writers' experiences creating a comprehensive neuro-ophthalmology registry and review of the literature. MRR are typically observational and prospective databases of de-identified patient information. The structure is flexible and can accommodate a focus on specific diseases or treatments, surveillance of patient populations, physician quality improvement, or recruitment for future studies. They are particularly useful for the study of rare diseases. They can be integrated into the hierarchy of medical research at many levels provided their construction is well organized and they have several key characteristics including an easily manipulated database, comprehensive information on carefully selected patients, and comply with human subjects regulations. MRR pertinent to neuro-ophthalmology include the University of Illinois at Chicago neuro-ophthalmology registry, Susac Syndrome Registry, Intracranial Hypertension Registry, and larger-scale patient outcome registries being developed by professional societies. MRR have a variety of forms and applications. With careful planning and clear goals, they are flexible and powerful research tools that can support multiple different study designs, and this can provide the potential to advance understanding and care of neuro-ophthalmic diseases.

Moderating effects of immunosuppressive medications and risk factors for post-operative joint infection following total joint arthroplasty in patients with rheumatoid arthritis or osteoarthritis.

Inconclusive findings about infection risks, importantly the use of immunosuppressive medications in patients who have undergone large-joint total joint arthroplasty, challenge efforts to provide evidence-based perioperative total joint arthroplasty recommendations to improve surgical outcomes. Thus, the aim of this study was to describe risk factors for developing a post-operative infection in patients undergoing TJA of a large joint (total hip arthroplasty, total knee arthroplasty, or total shoulder arthroplasty) by identifying clinical and demographic factors, including the use of high-risk medications (i.e., prednisone and immunosuppressive medications) and diagnoses [i.e., rheumatoid arthritis (RA), osteoarthritis (OA), gout, obesity, and diabetes mellitus] that are linked to infection status, controlling for length of follow-up. A retrospective, case-control study (N = 2212) using de-identified patient health claims information from a commercially insured, U.S. dataset representing 15 million patients annually (from January 1, 2007 to December 31, 2009) was conducted. Descriptive statistics, t-test, chi-square test, Fisher's exact test, and multivariate logistic regression were used. Male gender (OR = 1.42, p < 0.001), diagnosis of RA (OR = 1.47, p = 0.031), diabetes mellitus (OR = 1.38, p = 0.001), obesity (OR = 1.66, p < 0.001) or gout (OR = 1.95, p = 0.001), and a prescription for prednisone (OR = 1.59, p < 0.001) predicted a post-operative infection following total joint arthroplasty. Persons with post-operative joint infections were significantly more likely to be prescribed allopurinol (p = 0.002) and colchicine (p = 0.006); no significant difference was found for the use of specific disease-modifying anti-rheumatic drugs and TNF-α inhibitors. High-risk, post-operative joint infection groups were identified allowing for precautionary clinical measures to be taken.

Factors associated with poor adherence to antiviral treatment for hepatitis B.

Antiviral therapy for hepatitis B is effective and reduces the risk of progression to cirrhosis and liver cancer but is often required for an indefinite duration. Treatment adherence is important to prevent the development of resistance and optimize outcomes. Pharmacy adherence measures can be used to assess treatment adherence, with the medication possession ratio being less susceptible to bias than physician- or self-reported adherence. The aim of this study was to measure adherence in public hospital outpatients over a 3-year period and to examine factors associated with nonadherence. A retrospective study of pharmacy records of patients dispensed antiviral therapy for hepatitis B from four major hospitals in Melbourne between 2010 and 2013. Hospital record numbers were linked with and de-identified demographic information including age, sex, Indigenous status, country of birth, interpreter requirement, spoken language and postcode of residence. The medication possession ratio was the outcome measure with poor adherence defined <.90. Univariate logistic regression and multivariate logistic regression were performed to examine associations with nonadherence. Records of 1026 patients were included in the analysis. Twenty per cent of all participants met the definition of poor adherence. Significant factors affecting adherence included age <35 years (P=.002), hospital site and treatment by multiple doctors within shorter time periods. This is the largest study examining detailed factors associated with adherence to hepatitis B treatment. Understanding poor adherence in clinical settings, and the factors associated with lower adherence, is important to inform efforts towards promoting treatment adherence for hepatitis B.

Binder Highlights Five Areas Where Psychiatrists Must Remain Committed

At APA’s 2016 Annual Meeting, APA President Renee Binder, M.D., outlined key areas in which psychiatrists must take the lead to ensure that people with mental illness get the high-quality care they deserve.

Treatment patterns in patients with advanced gastric cancer in Taiwan.

To describe treatment patterns, outcomes and healthcare resource use in patients with metastatic and/or locally recurrent, unresectable gastric cancer (MGC) in Taiwan. Patients who had received first-line therapy (platinum and/or fluoropyrimidine) followed by second-line therapy or best supportive care (BSC) only were eligible. Participating physicians provided de-identified information from patient charts. Data were summarized descriptively and Kaplan-Meier analysis was used to describe time to events. Overall, 37 physicians contributed 122 patient charts. Of the 122 patients (median age, 61 years; 62% male), 43 (35%) received BSC only following first-line therapy, whereas 79 (65%) received second-line therapy. There was heterogeneity in second-line treatment, although fluoropyrimidine with or without a platinum agent was most frequently used. Median survival was 12.5 (interquartile range [IQR], 8.2-20.8) months from MGC diagnosis for patients receiving second-line therapy and 8.0 (IQR, 5.6-not reached) months for patients receiving BSC only. The most common treatment-related symptoms were nausea/vomiting (58%); the most common cancer-related symptoms were pain (61%), ascites (35%) and nausea/vomiting (33%). Inpatient and outpatient hospitalizations were numerically more common for patients receiving second-line therapy than for those receiving BSC only; the prevalence of hospice and skilled nursing facility stays were numerically more common for patients receiving BSC only. In this Taiwanese MGC population, 65% received active second-line therapy with heterogeneity seen in the regimen used. Clinical outcomes suggest an unmet medical need in this population. This study may help inform clinical practice and future research to ultimately improve patient outcomes in Taiwan.

The Public Repository of Xenografts Enables Discovery and Randomized Phase II-like Trials in Mice

More than 90% of drugs with preclinical activity fail in human trials, largely due to insufficient efficacy. We hypothesized that adequately powered trials of patient-derived xenografts (PDX) in mice could efficiently define therapeutic activity across heterogeneous tumors. To address this hypothesis, we established a large, publicly available repository of well-characterized leukemia and lymphoma PDXs that undergo orthotopic engraftment, called the Public Repository of Xenografts (PRoXe). PRoXe includes all de-identified information relevant to the primary specimens and the PDXs derived from them. Using this repository, we demonstrate that large studies of acute leukemia PDXs that mimic human randomized clinical trials can characterize drug efficacy and generate transcriptional, functional, and proteomic biomarkers in both treatment-naive and relapsed/refractory disease.

Disseminated glioneuronal tumors occurring in childhood: treatment outcomes and BRAF alterations including V600E mutation.

Disseminated glioneuronal tumors of childhood are rare. We present a retrospective IRB-approved review of the clinical course and frequency of BRAF mutations in disseminated glioneuronal tumors at two institutions. Defining features of our cohort include diffuse leptomeningeal-spread, often with a discrete spinal cord nodule and oligodendroglioma-like histologic features. Patients were identified through a pathology database search of all cases with disseminated low-grade neoplasms with an oligodendroglioma-like component. De-identified clinical information was collected by chart review and all imaging was reviewed. We retrieved the results of targeted genomic analyses for alterations in BRAF. Ten patients (aged 2-14years) were identified from the Dana-Farber/Boston Children's Hospital and the Royal Children's Hospital, Melbourne pathology databases. Nine patients received chemotherapy. Eight patients are alive, although three have had episodes of progressive disease. We identified genomic alterations affecting the MAPK pathway in six patients. One patient had a germline RAF1 mutation and a clinical diagnosis of cardio-facio-cutaneous syndrome. BRAF duplications were identified in four and BRAF V600E mutation was identified in one. These data support the presence of targetable genomic alterations in this disease.

Hemodialysis outcomes in a global sample of children and young adult hemodialysis patients: the PICCOLO MONDO cohort.

BackgroundThe aim of this study was to describe the experience of pediatric and young adult hemodialysis (HD) patients from a global cohort.MethodsThe Pediatric Investigation and Close Collaborative Consortium for Ongoing Life Outcomes for MONitoring Dialysis Outcomes (PICCOLO MONDO) study provided de-identified electronic information of 3244 patients, ages 0–30 years from 2000 to 2012 in four regions: Asia, Europe, North America and South America. The study sample was categorized into pediatric (≤18 years old) and young adult (19–30 years old) groups based on the age at dialysis initiation.ResultsFor those with known end-stage renal disease etiology, glomerular disease was the most common diagnosis in children and young adults. Using Europe as a reference group, North America [odds ratio (OR) 2.69; CI 1.29, 5.63] and South America (OR 4.21; CI 2.32, 7.63) had the greatest mortality among young adults. North America also had higher rates of overweight, obesity, hypertension, cardiovascular disease, hospitalizations and secondary diabetes compared with all other regions. Initial catheter use was greater for North American (86.4% in pediatric patients and 75.2% in young adults) and South America (80.6% in pediatric patients and 75.9% in young adults). Catheter use at 1-year follow-up was most common in North American children (77.3%) and young adults (62.9%). Asia had the lowest rate of catheter use. For both age groups, dialysis adequacy (equilibrated Kt/V) ranged between 1.4 and 1.5. In Asia, patients in both age groups had significantly longer treatment times than in any other region.ConclusionsThe PICCOLO MONDO study has provided unique baseline and 1-year follow-up information on children and young adults receiving HD around the globe. This cohort has brought to light aspects of care in these age groups that warrant further investigation.

Abstract A01: The efficacy of a diabetic registry to improve survival rates in under-resourced environments

Abstract Purpose: African Americans are disproportionately affected by diabetes and the associated complications of metabolic syndrome compared to Caucasians. Diabetes is the seventh leading cause of death in the United States thus contributing to over 300,000 deaths in the U.S. annually. Thirteen percent of those diagnosed are African Americans. Factors associated with optimally managing diabetes include periodic measures of Fasting Blood Glucose (FBG), Hemoglobin A1c (HgbA1c) and Body Mass Index (BMI). We hypothesize that a Diabetes/ Metabolic Disease Registry is an effective way to assess the management of diabetes and will assist in controlling and ultimately reducing morbidity and mortality rates, particularly in underserved communities. Methods: A diabetes metabolic disease registry was created based on best-practice clinical parameters. Demographic factors, co-morbidities and overall health maintenance were assessed. The instrument was evaluated using 52 de-identified patients' information from local Atlanta hospitals. The registry consisted of a comprehensive questionnaire with content pertinent to the diagnosis and management of diabetes such as BMI, HgbA1c and FBG. After inputting data, Statistical Analysis Software (SAS) was used for analysis. Lastly we evaluated the data input devices (smartphone versus computer) for ease and efficiency. Results: In this study, the mean age of the patients was 59 years of age. Eighty-eight percent were female. Over 60% of the patients were classified as obese or morbidly obese. Greater than 70% had persistently elevated levels of HgbA1C and over 65% had mildly or significantly elevated levels of FBG. Cholesterol and LDL levels were normal for about 80% of patients which indicates that those factors are not pertinent to managing diabetes. Conclusion: A Metabolic Disease Registry is an effective way to analyze diabetes management in underserved communities. Data was accurately entered at the exact same rate for both devices suggesting that both means of data entry (computers and smartphones) are equally as efficient. The elevated levels of HgbA1c and FGB in the majority of patients indicate that the serum glucose was not being controlled effectively, in spite of the fact that the majority of patients were under long-term care of a physician and had well defined care plans. We hope that this study will assist in controlling diabetes and lower the rates among those in underserved areas. Citation Format: Tania Anderson, Alexis Maynor, Derrick beech, Ernest Alema-Mensah. The efficacy of a diabetic registry to improve survival rates in under-resourced environments. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr A01.