Registry Entry Research Articles

Association Between Metformin and Sulfonylurea Monotherapies and Cancer Incidence: A Real-World Cohort Study in Shanghai, China.

IntroductionPrevious studies have shown that patients with type 2 diabetes mellitus have an increased risk of cancer. The use of antidiabetic medication (ADM) may play an important role in the cancer development. The relationship between oral ADM and cancer incidence has not been investigated in type 2 diabetes mellitus patients in mainland China yet.MethodsA community-based diabetes cohort was extracted from the Shanghai Community Diabetes Management System database, which is a patient registry from general practices. The cohort included 2353 newly onset type 2 diabetes mellitus patients from 2006 to 2010 aged 35 years or more. Patients were grouped into nonusers of antidiabetic medication (n = 722), metformin monotherapy (n = 374), sulfonylurea monotherapy (n = 653), metformin and sulfonylurea combination therapy (n = 302), and other medication therapies (n = 302) on the basis of initial treatment type at registry entry. Cancer incidence was identified from the Shanghai Cancer Registry Organization. Comparisons between monotherapy and nonuser of medication were conducted using Cox proportional hazards models.ResultsA total of 94 cancer cases were identified during 5 years median follow-up. Compared with nonusers, sulfonylurea monotherapy was associated with significantly lower risk of cancer [adjusted HR = 0.50 (95% CI 0.29–0.85)] whereas risk was 49% lower with metformin monotherapy [adjusted HR = 0.51 (95% CI 0.27–0.99)].ConclusionThe real-world evidence suggested that the use of metformin or sulfonylurea was associated with lower risk of cancer incidence in a cohort of newly onset type 2 diabetes mellitus patients.

The Impact of Systemic Lupus Erythematosus on the Clinical Phenotype of Antiphospholipid Antibody–Positive Patients: Results From the AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Clinical Database and Repository

Although systemic lupus erythematosus (SLE) is the most common autoimmune disease associated with antiphospholipid antibodies (aPL), limited data exist regarding the impact of SLE on the clinical phenotype of aPL-positive patients. The primary objective of this study was to compare the clinical, laboratory, and treatment characteristics of aPL-positive patients with SLE with those of aPL-positive patients without SLE. A secure web-based data capture system was used to store patient demographic characteristics and aPL-related clinical and laboratory characteristics. Inclusion criteria included positive aPL according to the updated Sapporo classification criteria. Antiphospholipid antibody-positive patients fulfilling the American College of Rheumatology criteria for the classification of SLE ("aPL with SLE") and those with no other autoimmune diseases ("aPL only") were included in the analysis. Six hundred seventy-two aPL-positive patients were recruited from 24 international centers; 426 of these patients did not have other autoimmune disease, and 197 had SLE. The frequency of thrombocytopenia, hemolytic anemia, low complement levels, and IgA anti-β2 -glycoprotein I (anti-β2 GPI) antibodies was higher in the aPL-positive patients with SLE, whereas the frequency of cognitive dysfunction and IgG anti-β2 GPI antibodies was higher in the aPL-only group. The frequency of arterial and venous thromboses (including recurrent) as well as pregnancy morbidity was similar in the 2 groups. The prevalence of cardiovascular disease risk factors at the time of entry into the registry entry did not differ between the 2 groups, with the exception of current smoking, which was more frequent in aPL-positive patients with SLE. Although the frequencies of thrombosis and pregnancy morbidity are similar in aPL-positive patients with and those without SLE, the diagnosis of SLE in patients with persistently positive aPL is associated with an increased frequency of thrombocytopenia, hemolytic anemia, low complement levels, and positive IgA anti-β2 GPI antibodies.

Sharing health research data - the role of funders in improving the impact.

Recent public health emergencies with outbreaks of influenza, Ebola and Zika revealed that the mechanisms for sharing research data are neither being used, or adequate for the purpose, particularly where data needs to be shared rapidly. A review of research papers, including completed clinical trials related to priority pathogens, found only 31% (98 out of 319 published papers, excluding case studies) provided access to all the data underlying the paper - 65% of these papers give no information on how to find or access the data. Only two clinical trials out of 58 on interventions for WHO priority pathogens provided any link in their registry entry to the background data. Interviews with researchers revealed a reluctance to share data included a lack of confidence in the utility of the data; an absence of academic-incentives for rapid dissemination that prevents subsequent publication and a disconnect between those who are collecting the data and those who wish to use it quickly. The role of the funders of research needs to change to address this. Funders need to engage early with the researchers and related stakeholders to understand their concerns and work harder to define the more explicitly the benefits to all stakeholders. Secondly, there needs to be a direct benefit to sharing data that is directly relevant to those people that collect and curate the data. Thirdly more work needs to be done to realise the intent of making data sharing resources more equitable, ethical and efficient. Finally, a checklist of the issues that need to be addressed when designing new or revising existing data sharing resources should be created. This checklist would highlight the technical, cultural and ethical issues that need to be considered and point to examples of emerging good practice that can be used to address them.

Sharing health research data – the role of funders in improving the impact

Recent public health emergencies with outbreaks of influenza, Ebola and Zika revealed that the mechanisms for sharing research data are neither being used, or adequate for the purpose, particularly where data needs to be shared rapidly. A review of research papers, including completed clinical trials related to priority pathogens, found only 31% (98 out of 319 published papers, excluding case studies) provided access to all the data underlying the paper - 65% of these papers give no information on how to find or access the data. Only two clinical trials out of 58 on interventions for WHO priority pathogens provided any link in their registry entry to the background data. Interviews with researchers revealed a reluctance to share data included a lack of confidence in the utility of the data; an absence of academic-incentives for rapid dissemination that prevents subsequent publication and a disconnect between those who are collecting the data and those who wish to use it quickly. The role of the funders of research needs to change to address this. Funders need to engage early with the researchers and related stakeholders to understand their concerns and work harder to define the more explicitly the benefits to all stakeholders. Secondly, there needs to be a direct benefit to sharing data that is directly relevant to those people that collect and curate the data. Thirdly more work needs to be done to realise the intent of making data sharing resources more equitable, ethical and efficient. Finally, a checklist of the issues that need to be addressed when designing new or revising existing data sharing resources should be created. This checklist would highlight the technical, cultural and ethical issues that need to be considered and point to examples of emerging good practice that can be used to address them.

Sharing health research data - the role of funders in improving the impact.

Recent public health emergencies with outbreaks of influenza, Ebola and Zika revealed that the mechanisms for sharing research data are neither being used, or adequate for the purpose, particularly where data needs to be shared rapidly. A review of research papers, including completed clinical trials related to priority pathogens, found only 31% (98 out of 319 published papers, excluding case studies) provided access to all the data underlying the paper - 65% of these papers give no information on how to find or access the data. Only two clinical trials out of 58 on interventions for WHO priority pathogens provided any link in their registry entry to the background data. Interviews with researchers revealed a reluctance to share data included a lack of confidence in the utility of the data; an absence of academic-incentives for rapid dissemination that prevents subsequent publication and a disconnect between those who are collecting the data and those who wish to use it quickly. The role of the funders of research needs to change to address this. Funders need to engage early with the researchers and related stakeholders to understand their concerns and work harder to define the more explicitly the benefits to all stakeholders. Secondly, there needs to be a direct benefit to sharing data that is directly relevant to those people that collect and curate the data. Thirdly more work needs to be done to realise the intent of making data sharing resources more equitable, ethical and efficient. Finally, a checklist of the issues that need to be addressed when designing new or revising existing data sharing resources should be created. This checklist would highlight the technical, cultural and ethical issues that need to be considered and point to examples of emerging good practice that can be used to address them.

Practitioner Gender and Quality of Care in Ambulatory Cardiology Practices: A Report From the National Cardiovascular Data Practice Innovation and Clinical Excellence (PINNACLE) Registry.

Some studies suggest that female practitioners are more likely to provide guideline-concordant care than male practitioners; however, little is known about the role of practitioner gender in cardiology. The aim of the study was to measure the association between practitioner gender and adherence to the cardiovascular performance measures in the American College of Cardiology's ambulatory Practice Innovation and Clinical Excellence Registry. Patients with at least 1 outpatient visit with a unique practitioner were included. Among eligible patients, adherence to 7 guideline-supported performance measures for coronary artery disease, heart failure, and atrial fibrillation over 12 months after registry entry was compared by practitioner gender using hierarchical models adjusting for practitioner type (physicians vs advance practice practitioners) and number of visits. The study cohort included 1493 individual practitioners who saw 769 139 patients; 80% of practitioners were men. Male practitioners were more often physicians compared with female practitioners (98.2% vs 43.7%, P < .01). Accounting for practitioner category and visit frequency, guideline adherence rates were similar by practitioner gender for all measures with the exception of marginally higher rates for coronary artery disease performance measures for male practitioners compared with female practitioners (antiplatelet: rate ratio [RR] = 1.06; 95% confidence interval [CI], 1.03-1.09; β-blockers: RR = 1.06; 95% CI, 1.01-1.10; and lipid-lowering drug: RR = 1.07; 95% CI, 1.04-1.10) and atrial fibrillation (oral anticoagulants: RR = 1.05; 95% CI, 1.01-1.09). Male practitioners marginally outperformed their female counterparts in ambulatory practices enrolled in a voluntary cardiovascular performance improvement registry program. Overall low adherence to some performance measures suggests room for improvement among all practitioners.

Early Respiratory Bacterial Detection and Antistaphylococcal Antibiotic Prophylaxis in Young Children with Cystic Fibrosis

Consensus is lacking regarding antistaphylococcal antibiotic prophylaxis use for young children with cystic fibrosis. Prophylaxis is recommended in the United Kingdom, but it is recommended against in the United States. To test the hypothesis that antistaphylococcal antibiotic prophylaxis is associated with a decreased risk of Staphylococcus aureus acquisition but no increased risk of Pseudomonas aeruginosa acquisition. We undertook a longitudinal observational study of children with cystic fibrosis who were recruited from birth (or from their first registry entry in the period) and followed until the age of 4 years (1,500 d) using 2000-2009 data from the UK Cystic Fibrosis Trust and Cystic Fibrosis Foundation registries. Children were excluded if they had a positive culture result for S. aureus or P. aeruginosa, or if they were receiving inhaled antibiotics, at the first encounter. Time to first S. aureus and P. aeruginosa detection in the UK/U.S. cohorts was compared using a Cox proportional hazards model. A UK-based analysis compared the same for those receiving flucloxacillin with those who received no prophylaxis. We included the following covariates: sex, age at registry entry, dornase alfa use, genotype, and center size. The primary analysis comprised 1,074 UK and 3,677 U.S. children. The risk of first detection was greater in U.S. children than in UK children for S. aureus (hazard ratio [HR], 5.79; 95% confidence interval [CI], 4.85, 6.90; P < 0.001) and P. aeruginosa (HR, 1.92; 95% CI, 1.65, 2.24; P < 0.001). In the UK analysis, we compared 278 children receiving flucloxacillin and 306 receiving no prophylaxis. Flucloxacillin was not associated with a reduced risk of S. aureus detection (HR, 1.22; 95% CI, 0.74, 2.0; P = 0.43), but it was associated with an increased risk of P. aeruginosa detection (HR, 2.53; 95% CI, 1.71, 3.74; P < 0.001). None of the covariates significantly affected the risk estimate in either analysis. The risk of first detection of S. aureus and P. aeruginosa was greater in the United States than in the United Kingdom. In the United Kingdom, the risk of first P. aeruginosa detection was increased among those receiving flucloxacillin compared with those who received no prophylaxis. These observational findings should be examined in randomized controlled trials.

THE SURVEY OF CANCER PATIENTS IN THE REGION OF GUNTUR: BASED ON HOSPITAL REGISTRY

&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This survey was conducted to estimate the number of cancer patients in the region of Guntur-based on sex, age and cancer groups. The data were obtained from the hospital-based registries from Bommidala Cancer Institute, NRI Hospital&lt;strong&gt;, &lt;/strong&gt;Balaji Cancer Care Center&lt;strong&gt;, &lt;/strong&gt;and Govt. General Hospital, which was scrutinized and analysed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The hospital registry entry was considered suitable for assessing the cancer cases in the region of Guntur. In addition, data of NCRP were utilised for comparing the obtained results.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The data comprehensively constitutes of 309 patients. Out of which men were 74 (23.95%), and women were 235 (76.05%) who had obtained treatment for various cancer conditions between March-May, 2016. In these hospitals, cancers pertaining to the cervix-83 (31.32%), breast-52 (19.62%), ovary–17 (6.41%), lymphoid-11 (4.15%), pharynx-10 (3.77%), endometrium-10 (3.77%), astrocytoma-08 (3.02%), colon-07 (2.64%), larynx-06 (2.26%), rectum–06 (2.26%), oesophagus–05 (1.88%), post cricoids-04 (1.50%), stomach–04 (1.50%), liver–03 (1.13%) were the leading sites in order. While among these cases, radiation therapy patients were 194 (62.78%), chemotherapy patients were 78 (25.24%), and surgery patients were 37 (11.97 %).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Survey reports the highest incidence of cancer cases to be cervix cancer among the women while it was pharyngeal cancer which precedes lung cancer among the men. This hospital-based registry survey is a report that provided internal consistency, reliability and validity.&lt;/p&gt;

Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: ACTTION systematic review

ObjectiveTo examine whether primary reports of randomized clinical trials (RCTs) in six high-impact, general medical journals reported (1) whether or not a Data Monitoring Committee/Data and Safety Monitoring Board (DMC/DSMB) was used and (2) the composition of the responsibilities of the reported DSMB/DMCs. Study Design and SettingSystematic review of RCTs published in 2014 in Annals of Internal Medicine, BMJ, NEJM, JAMA, JAMA Internal Medicine, and Lancet. ResultsOf the 294 articles identified, 174 (59%) mentioned using a DMC/DSMB. Of these 174, 126 (72%) indicated at least one responsibility of the DMC/DSMB, 26% listed the names of the DMC/DSMB members, and another 14% listed both their names and affiliations. Only one article stated that a DSMB was not used. The remaining 119 articles did not report whether or not a DMC/DSMB was used, although 59 had previously stated in a clinical trials registry entry or a published protocol that a DMC/DSMB was to be used. ConclusionsConsidering the major role that DMC/DSMBs play in protecting participant safety, data quality, and interim analyses in RCTs, we recommend that authors of publications of RCTs report whether a DMC/DSMB was used and the responsibilities and members of DMC/DSMBs to increase transparency regarding study conduct.

A study comparing trial registry entries of randomized controlled trials with publications of their results in a high impact factor journal: The Journal of the American Medical Association.

Purpose:The International Committee of Medical Journal Editors mandates trial registration as a precondition for publication. Growing evidence indicates that information in registry may not correlate with eventual publication. The present study was carried out with the objective of comparing content of Randomized Controlled Trials (RCTs) published in one year in the Journal of the American Medical Association (JAMA), with the information contained in trial registries.Methods:All RCTs published in JAMA in 2013 were included. 11 data set items were matched for content between registry entry and published RCT: Title, Primary and Secondary Objectives, Study type, Inclusion and Exclusion Criteria, Treatment Age Group, Follow up, Sample Size, Primary and Secondary Outcomes. A fully correct match was scored 2, partially correct 1 and incorrect 0. Thus, maximum possible score for each paper was number of items multiplied by 2, i.e., 22.Results:The median [range] total score achieved by RCTs was 15. No RCT achieved a perfect score of 22. The largest proportion of RCTs reported secondary objectives, study type, treatment age group, follow up, sample size and primary outcomes fully correctly. However, only 13.5 %, 12 % and 13.5 % of RCTs were a perfect match with registry entries in terms of title, primary objective and secondary outcomes respectively. Almost three quarters did not match perfectly in selection criteria.Conclusion:There exist discrepancies between trial registration and published paper even in a high impact factor journal. Both authors and editors should adhere to CONSORT guidelines to ensure transparency of published research.

The contribution of antiphospholipid antibodies to organ damage in systemic lupus erythematosus.

The objective of this study was to assess the contribution of clinically significant antiphospholipid antibodies (aPL) to organ damage in systemic lupus erythematosus (SLE). Patients with disease duration of less than 10 years and at least 5 years of follow-up were identified from two SLE registries. A clinically significant antiphospholipid antibody (aPL) profile was defined as: positive lupus anticoagulant, anticardiolipin IgG/M ≥ 40 G phospholipid units (GPL)/M phospholipid units (MPL), and/or anti-β2-glycoprotein-I IgG/M ≥ 99th percentile on two or more occasions, at least 12 weeks apart. Organ damage was assessed by the Systemic Lupus International Collaborating Clinics Damage Index (SDI). Univariate and multivariate analysis compared SLE patients with and without SDI increase during a 15-year follow-up. Among 262 SLE patients, 33% had a clinically significant aPL profile, which was associated with an increased risk of organ damage accrual during a 5-year follow-up in univariate analysis, and during a 15-year follow-up in the multivariate analysis adjusting for age, gender, race, disease duration at registry entry, and time. In the multivariate analysis, older age at diagnosis and male gender were also associated with SDI increase at each time point. A clinically significant aPL profile is associated with an increased risk of organ damage accrual during a 15-year follow-up in SLE patients.

Abstract 11940: Aortic Complications Associated With Pregnancy in Marfan Syndrome: The NHLBI GenTAC Registry

Background: Definition of pregnancy risk in women with Marfan syndrome (MFS) has been confounded by ascertainment bias, lack of imaging data, small sample size, and inclusion of women without a known MFS diagnosis before a pregnancy complication. To lessen these limitations, we analyzed MFS women participating in the large GenTAC Registry. Results: Among 184 women in whom pregnancy information was available, 94 women (51%) had a total of 227 pregnancies (average 2.5, range 1-6). Compared to MFS women who never became pregnant, those with pregnancies were older at time of MFS diagnosis (27 vs. 13 years, p&lt;0.0001) and at time of GenTAC enrollment (47 vs. 37 years, p&lt;0.0001). When comparing ever-pregnant to never-pregnant women with MFS at the time of registry entry, higher historical rates of aortic dissection and prophylactic proximal aortic surgery were observed (24/94 [25.5%] vs. 13/90 [14.4%], p=0.068 and 15/94 [16.0%] vs. 4/90 [4.4%], p=0.014; respectively). Among the 94 MFS women with pregnancies, 10 (10.6%) experienced a pregnancy-related aortic complication (4 Type A and 3 Type B dissections, one coronary artery dissection, and 2 with significant [≥3 mm] aortic growth, 1 of whom required post-partum prophylactic surgery). Four of the aortic dissections, including all 3 Type B, and the coronary dissection occurred in the post-partum period. Only 3 of 7 women (43%) with an aortic dissection related to pregnancy were aware of their MFS diagnosis before pregnancy. Women with and without pregnancy-associated aortic complications did not differ in phenotypic features. The rate of aortic dissection was higher during pregnancy + post-partum period (3.5 per 100 person-years vs. 0.8 per 100 person-years, odds ratio 4.6 [95% confidence interval 2.1-10.1], p=0.0002). Conclusions: Pregnancy in MFS is associated with an increased risk of aortic dissection, both Types A and B, particularly in the immediate post-partum period, and more frequent prophylactic surgery. Lack of knowledge of underlying MFS diagnosis before aortic dissection is a major contributing factor. These findings underscore the need for early diagnosis, pre-pregnancy risk counselling, and multi-disciplinary peri-partum management.

Registration status and outcome reporting of trials published in core headache medicine journals.

To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue.

The GOLD ReGISTry: a Global, Prospective, Observational Registry Collecting Longitudinal Data on Patients with Advanced and Localised Gastrointestinal Stromal Tumours

BackgroundGastrointestinal stromal tumours (GISTs) are the most common gastrointestinal sarcomas. This global, prospective registry followed patients with advanced or localised GIST (2007–2011). MethodsCurrent and evolving diagnostics, treatments and outcome measures in patients with GIST were assessed. Eligible patients were diagnosed with advanced or localised GIST within 15months of registry entry. No treatment plan was prescribed, and no visit schedule was mandated. Treating physicians recorded patient information, including tumour response, diagnostic methods, medications, surgeries performed, mutation status and adverse events leading to dose/medication changes. Survival outcomes were estimated using the Kaplan–Meier method. Other data were analysed using descriptive statistics. ResultsThe registry included 1663 patients (advanced GIST, n=1095; localised GIST, n=537). Medications (e.g. tyrosine kinase inhibitor use and dosing), disease progression or recurrence and physician assessment of response to treatment in registry patients were consistent with controlled trials and prevailing clinical recommendations. In advanced GIST, estimated 30-month progression-free survival (PFS) (59.8%) and overall survival (OS) (82.7%) were higher than results from previously reported trials (≈40% and ≈70%, respectively). Consistent with treatment guidelines, the most common initial treatments were imatinib for advanced GIST, and complete surgical resection for localised GIST. Computed tomography scans were the most common imaging technique used at diagnosis and follow-up. Mutation analysis was performed at diagnosis in only 15.3% and 14.5% of patients with advanced and localised GIST, respectively. ConclusionsIn this real-world GIST registry, patients with advanced GIST were treated with imatinib and patients with localised GIST received surgical resection, in accordance with prevailing clinical recommendations.

OSTEOPOROSIS IN THE COMMUNITY: FINDINGS FROM A NOVEL COMPUTERIZED REGISTRY IN A LARGE HEALTH ORGANIZATION IN ISRAEL

Background: Osteoporosis is a growing public health concern due to its rising prevalence and excess morbidity and mortality. Automated patient registries have gained great importance in health and disease management of major chronic diseases, but are rarely used in osteoporosis. Objectives: To construct an automated, population-based registry of osteoporosis. Setting: The electronic medical records and pharmacy databases of a 2 million member health organization in Israel (Maccabi Healthcare Services). Methods: Included in the registry were adults who were diagnosed with osteoporosis diagnosis, had major osteoporotic fractures, or purchased relevant medications, between 2000 and 2013. In addition, we included patients with low bone density as extracted from over 140,000 measurements reports, using an automated optical character recognition (OCR) system. Two-thirds of the cases were validated by more than one inclusion criterion. Results: A total of 118,141 osteoporosis patients were identified. The point prevalence of osteoporosis among members aged 50 or above in 2013 was 19%. The mean age at registry entry was 62 (SD=12) and 66 (SD=14) years for females and males, respectively. The highest annual risk of developing osteoporosis (27 per 1000) was recorded among females aged 65-75. In 28% of the patients, there was no indication of treatment with osteoporosis therapy. Conclusions: To the best of our knowledge, this is one of the first real-world automated registries of osteoporosis. Similar registries may provide valuable data for real-time monitoring of trends, quality of care, and outcome research in osteoporosis and its complications.

Gastroenteropancreatic Neuroendocrine Tumors (Gepnet) Registry: Update from an International Collaboration

ABSTRACT Aim: Epidemiologic data for GEPNET is lacking in many geographic areas. The aim of the GEPNET Registry is to study the prevalence, incidence, regional trends in diagnosis, and clinical management of GEPNET in the Asia-Pacific, Middle East, Turkey and South Africa. Methods: Patients (pts) with histopathological diagnosis of GEPNET within 5 years (yrs) of registry entry were included. Pro- and retrospective data were collected at 82 sites. Enrollment in the registry was from July 2009 to December 2012. Follow-up will be for 5 yrs. Results: As of December 1, 2013 (cut-off for this interim analysis), 1005 pts were enrolled, 933 were evaluable. At diagnosis, median age was 54 yrs [range: 12-87], gender ratio was balanced (49% male). The majority of pts (740/933, 77%) had symptoms at the time of diagnosis. Abdominal pain and weight loss were the most commonly reported symptoms. The most frequently reported primary site was the pancreas (42%) followed by the stomach (17%). The majority of pts had well-differentiated tumors (70%). Immunostaining results for Synaptophysin and Chromogranin A were reported for the majority of patients (77% and 82% respectively). Proliferative indices were less frequently reported; mitotic index: 17% and Ki-67: 50% pts. Use of computed tomography scanning was the main modality of disease evaluation (44% pts). Other imaging modalities including functional PET and octreotide scintigraphy were used in Conclusions: The GEPNET Registry continues to provide important information as it relates to the diagnosis and treatment of patients in the participating countries. This analysis has highlighted the need for clinical practice improvement to ensure better evaluation of patients. Disclosure: S. Yalcin: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials. S. Glasberg: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; H. Abali: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; F. Aykan: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; L. Bai: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; J. Kattan: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; H.Y. Lim: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; Y.S. Park: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; H. Raef: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; J. Ramos: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; K. Rau: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; S. Saglam: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; S. Serdengecti: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; A. Sevinc: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; Y. Shan: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; Y. Shyr: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials.; V. Sriuranpong: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; S.N. Turhal: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; K. Yeh: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials; T. Hwang: Member of Novartis Advisory Board; Institution participates in Novartis-sponsored clinical trials.

Growth in children with chronic kidney disease: 13 years follow up study

Growth retardation is one of the most visible comorbid conditions of chronic kidney disease (CKD) in children. To our knowledge, published data on longitudinal follow-up of growth in pediatric patients with CKD is lacking from the region of South-East Europe. Herein we report the results from the Serbian Pediatric Registry of Chronic Kidney Disease. The data reported in the present prospective analysis were collected between 2000 and 2012. A total of 324 children with CKD were enrolled in the registry. Prevalence of growth failure at registry entry was 29.3 %. Mean height standard deviation scores (HtSDS) in children with stunting and those with normal stature were -3.00 [95 % confidence interval (CI) -3.21 to -2.79] and -0.08 (95 % CI -0.22 to 0.05) (p < 0.001), respectively. Children with hereditary nephropathy had worse growth at registration (-1.51; 95 % CI -1.97 to -1.04, p = 0.008). Those with CKD stages 4 and 5 before registration had more chance to have short stature at registration than those with CKD stages 2 and 3 [odds ratio (OR) = 0.458, CI 0.268-0.782, p = 0.004]. Dialysis was an independent negative predictor for maintaining optimal stature during the follow-up period (OR = 0.324, CI = 0.199-0.529, p < 0.001), while transplantation was an independent positive predictor for improvement of small stature during follow-up (OR = 3.706, CI = 1.785-7.696, p < 0.001). Growth failure remains a significant problem in children with CKD, being worst in patients with hereditary renal disease. Growth is not improved by standard dialysis, but transplantation has a positive impact on growth in children.

A85: Effect of Childhood‐Onset Systemic Lupus Erythematosus on Linear Height and Body Mass Index

Background/Purpose:To explore the relationship between childhood‐onset systemic lupus erythematosus (SLE) and anthropomorphic measures including linear height and body mass index (BMI).Methods:Cross‐sectional data were obtained from the CARRAnet registry, a United States pediatric rheumatology database. Subjects included in the database were diagnosed with SLE at ≤18 years of age and were ≤ age 21 at enrollment. Subject height and BMI at registry entry were recorded and compared with the US Centers for Disease Control and Prevention standardized growth charts for age and sex in order to obtain the appropriate percentiles. A history of renal disease was defined by a prior history of a renal biopsy. Chi squared testing was used to examine associations between height and BMI percentiles and history of renal disease and daily, chronic steroid use.Results:Data from 834 subjects were analyzed. Median age of onset was 12.3 years (range 0.88–17.32 years), median age at baseline was 15.5 years (range 3.1–20.4 years); 84% were female. Race/ethnicities included African American (35%), Caucasian (48%), Hispanic/Latino (27%), Asian (12%) and other (5%). The mean height percentile for the entire cohort was 40% (SD ± 30.6) with a median height percentile of 35% (range 1–100). Twenty one percent of the cohort (n = 174) had a height percentile of &lt;10%. Mean height percentiles by age group at registry entry were as follows: &lt;11 years (n = 67), 42%; 11–14 years (n = 159), 43% and &gt;14 years (n = 608), 40%. In univariate analysis, height was not associated with a history of renal disease or long term daily steroid exposure. The mean BMI percentile was 69% (SD ± 38), median percentile was 78% (range 1–100). One‐third of the cohort (n = 276) had a BMI percentile of ≥90%. In univariate analysis, a BMI of ≥90% was associated with renal disease (p = 0.016) but not long term daily steroid exposure.Conclusion:In this large cohort of subjects with childhood‐onset SLE, average height was reduced and BMI was increased as compared to the general population. Longitudinal studies of this population are needed to assess change in height and BMI over time, and to determine the impact of age of disease onset, disease activity and treatment on these important anthropomorphic measures.

Patterns of Long‐term Thienopyridine Therapy and Outcomes in Patients With Acute Coronary Syndrome Treated With Coronary Stenting: Observations From the TIMI‐38 Coronary Stent Registry

The optimal duration of dual antiplatelet therapy (DAPT) after acute coronary syndrome (ACS) is not known. Factors influencing DAPT duration are not well described. We hypothesized that continued DAPT 12 months beyond ACS would be associated with patient factors such as stent type and that it may be associated with lower rates of ischemic events. The TIMI 38 Coronary Stent Registry (CSR) followed patients who completed the TRITON-TIMI 38 trial, received a stent, and were alive and event free. Continuation of DAPT was determined by the treating physician. The CSR enrolled 2110 patients (1679>12 months from index ACS) and followed for a median of 2.1 additional years. DAPT was continued in 554 (26%) and was more likely to be continued in patients with drug-eluting stents (DES; 54%) and in North America. The rate of cardiovascular death, MI, or stroke was 2.35% per year, and 13 patients (0.6%) experienced Academic Research Consortium definite or probable ST. Recurrent ischemic events were similar between patients who continued thienopyridine therapy and those who stopped at registry entry (P = 0.74 for cardiovascular death/MI/stroke; P = 0.72 for definite or probable ST). After propensity score adjustment, there was no significant difference in cardiovascular death/MI/stroke (P = 0.55) or bleeding (P = 0.51) with prolonged DAPT. Patients stabilized for a year after ACS and stenting have low rates of ST relative to overall cardiovascular events. The decision to continue DAPT maybe associated with stent type (DES vs bare-metal stent) and region.

Dietary Habits and Weight Maintenance Success in High Versus Low Exercisers in the National Weight Control Registry

The National Weight Control Registry (NWCR) was established to examine characteristics of successful weight loss maintainers. This study compares the diet and behavioral characteristics and weight regain trajectories of NWCR members with differing physical activity (PA) levels at baseline. Participants (n = 3591) were divided into 4 levels of self-reported PA at registry entry (< 1000, 1000 to < 2250, 2250 to < 3500, and ≥ 3500 kcals/week). We compared self-reported energy intake (EI), macronutrient composition, eating behaviors (dietary restraint, hunger, and disinhibition), weight loss maintenance strategies, and 3 year weight regain between these 4 activity groups. Those with the highest PA at registry entry had lost the most weight, and reported lower fat intake, more dietary restraint, and greater reliance on several specific dietary strategies to maintain weight loss. Those in the lowest PA category maintained weight loss despite low levels of PA and without greater reliance on dietary strategies. There were no differences in odds of weight regain at year 3 between PA groups. These findings suggest that there is not a "one size fits all strategy" for successful weight loss maintenance and that weight loss maintenance may require the use of more strategies by some individuals than others.