Received Research Grant Support Research Articles

Place of care and costs associated with acute episodes and remission in schizophrenia.

BACKGROUND: Schizophrenia imposes significant economic burden on patients, families, caregivers, and society. To our knowledge, place of care and associated costs of acute schizophrenia episodes have not been well characterized. OBJECTIVE: To describe the care settings and costs associated with likely acute episodes and untreated remission periods among patients with schizophrenia. METHODS: Adults with schizophrenia were identified using the IBM MarketScan Commercial and Medicare Supplemental databases (2009-2018); claims for capitated benefits plans were excluded. Acute episode index date was defined as at least 1 inpatient schizophrenia claim or outpatient schizophrenia claim (frequency of claim dependent on visit type, such as hospitalization, emergency department, private practice, clinic, urgent care, or laboratory). Mental health-related medical costs (health plan+patient) associated with acute episodes were collected over a 2-month follow-up period and stratified by setting (inpatient vs outpatient); acute episode data were reported in subgroups of patients without or with prior clozapine use, as an indication of disease severity. Remission index date was defined as at least 1 outpatient claim with a schizophrenia diagnosis with no acute episode and no oral or injectable antipsychotic therapy. Remission costs were assessed over a 3-month period. All data were analyzed descriptively. RESULTS: A total of 14,824 patients with schizophrenia met criteria for an acute episode (12,896 [87.0%] without prior clozapine use; 1,427 [9.6%] with prior clozapine use). Most acute episodes were treated in an outpatient setting (all patients, 76.3%; without prior clozapine use, 74.5%; with prior clozapine use, 87.1%). When treated inpatient, mean (SD) episode medical costs were $17,045 ($28,101) for all patients, $16,060 ($22,786) for those without prior clozapine use, and $22,827 ($55,860) for those with prior clozapine use. When treated outpatient, mean (SD) medical costs for acute episodes were $2,478 ($6,961) for all patients, $2,609 ($7,068) for those without prior clozapine use, and $1,770 ($6,560) for those with prior clozapine use. For all patients with acute episodes, regardless of clozapine use, patient-incurred out-of-pocket costs were approximately 30% of total medical costs. For an untreated period of remission, 6,950 patients with schizophrenia met criteria. Total medical costs were $2,399 for these patients over a 3-month period. CONCLUSIONS: The majority of acute schizophrenia episodes were treated in the outpatient setting. For episodes that required inpatient care, inpatient episodes were approximately 7 times more costly than episodes treated in outpatient-only settings. For acute episodes and remission periods, health plans covered most costs; however, there were additional patient-incurred out-of-pocket costs. DISCLOSURES: All authors met the International Committee of Medical Journal Editors authorship criteria. Neither honoraria nor payments were made for authorship. Dr McIntyre has received research grant support from CIHR/GACD/National Natural Science Foundation of China (NSFC) and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, Atai Life Sciences. Dr McIntyre is a CEO of Braxia Scientific Corp. Mr Doan, Dr Amari, and Mr Mercer are employees of Genesis Research, which was funded to perform the study. Ms Higa, Dr Gillard, and Dr Harrington were employees of AbbVie at the time of the study and may hold stock. This study was sponsored by AbbVie.

ISPAD Clinical Practice Consensus Guidelines 2022: Diabetes technologies: Insulin delivery.

J.L.S. reports having received speaker honoraria from Eli Lilly, Insulet, Medtronic, and Zealand and serves on advisory boards of Bigfoot Biomedical, Cecelia Health, Insulet Corporation, Medtronic Diabetes, JDRF T1D Fund, and Vertex. She has been a consultant for Insulet and Medtronic. J.L.S.'s institution received research grant support from JDRF, Medtronic, Insulet, and NIDDK. M.S. reports research grant support, paid to her institution, from Tandem Diabetes Care, Insulet, Medtronic, JDRF, and NIDDK. T.S. has no conflict to disclose. L.R. reports speaker fees from Sanofi, Pfizer, NovoNordisk. T.B. reports speaker fees, consulting honoraria or research support from AstraZeneca, Ascensia, DexCom, Medtronic, NovoNordisk, Roche, Sanofi, and Ypsomed. Since 2021, he is member of the Expert group for medical devices of the European Medicines Agency. A.G. received speaker honoraria from Ypsomed. A.G.'s institution received research support from the European Commission (H2020 program). J.V. has no conflict to disclose. M.E.H. receives research grant support from NIDDK, JDRF, and The Leona M. and Harry B. Helmsley Charitable Trust. C.B. has been a consultant for Insulet. L.A.D. reports that in the last 3 years she has consulted for Vertex and served on a Mannkind, Merck, and Abata adivosry board. She has also recieved research support to her instiution from Caladrius, Lilly, Mannkind, Medtronic, Provention, and Zealand. The peer review history for this article is available at https://publons.com/publon/10.1111/pedi.13421. JLS reviewed the literature, drafted sections of the guidelines, oversaw completion of the first draft of the guidelines, and edited the manuscript. MS, TD, LR, TB, AG, JV, MEH and CB reviewed the literature, provided drafts of sections and edited the manuscript. LAD outlined the guidelines, reviewed the literature, edited the manuscript, and served as the senior author. The authors gratefully acknowledge the editorial assistance of Dr. Leena Priyambada. Data sharing not applicable to this article as no datasets were generated or analysed during the current study.

Identification of outcomes in clinical studies of interventions for venous thromboembolism in non‐pregnant adults

Identification of outcomes in clinical studies of interventions for venous thromboembolism in non‐pregnant adults

An Open-label, Crossover Study Comparing EPA+DPA-Free Fatty Acids and EPA-Ethyl Esters in Adults with Elevated Triglycerides: ENHANCE-IT

<h3>Lead Author's Financial Disclosures</h3> K.C.M. has received consulting fees from Matinas BioPharma, Inc., Acasti Pharma, Inc., New Amsterdam Pharma, Pharmavite, and 89Bio. He has received research grant support from Matinas BioPharma, Inc, and Pharmavite. <h3>Study Funding</h3> Matinas BioPharma, Inc. <h3>Background/Synopsis</h3> Few head-to-head studies have directly compared the efficacy of prescription omega-3 fatty acid (OM-3) products. Both the degree of triglyceride (TG) lowering and the achieved blood levels of individual OM-3 fatty acids are important predictors of clinical efficacy. MAT9001 is a unique OM-3 free-fatty-acid (FFA) formulation, containing mainly eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA). A prior crossover study comparing EPA+DPA-FFA and icosapent ethyl (EPA-EE - an ethyl ester EPA formulation) showed enhanced TG lowering and higher EPA levels with EPA+DPA-FFA when both agents were administered with a very-low fat diet and once daily dosing. <h3>Objective/Purpose</h3> To compare pharmacodynamic responses and plasma OM-3 levels following 28-day twice daily treatment with EPA+DPA-FFA and EPA-EE in hypertriglyceridemic subjects consuming a Therapeutic Lifestyle Changes diet. <h3>Methods</h3> This open-label, 2-way crossover trial was conducted at 8 centers in the US and included 100 subjects with fasting TG 150-499 mg/dL (median 204 mg/dL; 57% female, average age 60.3 years). Participants were randomized to EPA+DPA-FFA or EPA-EE for 28 days, washed out for at least 28 days, and then crossed over to the other therapy. Both drugs were given as 2 g twice daily, with meals. The primary endpoint was least squares geometric mean (LSGM) % change from baseline in plasma TG. Additional measurements included other lipoprotein-related markers, high-sensitivity C-reactive protein (hs-CRP) and plasma levels of individual OM-3 fatty acids. <h3>Results</h3> Ninety-four subjects had analyzable data for both treatment periods. EPA+DPA-FFA and EPA-EE reduced TG from baseline: 20.9% and 18.3%, respectively (p=NS). EPA+DPA-FFA reduced hs-CRP by 5.8% compared with an increase of 8.5% with EPA-EE (p = 0.034). EPA+DPA-FFA increased LSGM plasma EPA, DPA, and total OM-3 concentrations by 848%, 692%, and 177% respectively, which were greater than corresponding changes with EPA-EE of 140%, 205%, and 165%, respectively (all p < 0.001). EPA+DPA-FFA increased docosahexaenoic acid (DHA) by 1.7%; EPA-EE decreased DHA by 3.3% (p = 0.011). Responses for lipoprotein cholesterol levels (total, VLDL, LDL, HDL) and apolipoprotein (A-1, B and C-3) did not differ between treatments. <h3>Conclusions</h3> These results demonstrate that a FFA formulation of EPA+DPA produced significantly higher plasma EPA, DPA and total OM-3 levels compared with an EE formulation of EPA, and support the

Cardiac Scintigraphy and Screening for Transthyretin Cardiac Amyloidosis: Caveat Emptor.

Cardiac Scintigraphy and Screening for Transthyretin Cardiac Amyloidosis: Caveat Emptor.

Findings from a multicentre, observational study on reproductive outcomes in women with unexplained recurrent pregnancy loss: the OTTILIA registry.

What evaluation and care is offered to women after unexplained recurrent pregnancy loss (RPL) or intra-uterine foetal death (IUFD) and what are the reproductive outcomes? Women are assessed for thrombophilia and often treated with low-molecular weight heparin (LMWH) and/or low-dose aspirin (ASA). Randomized controlled trials (RCTs) on possible efficacy of heparins and/or aspirin have been inconclusive due to limited power to detect a difference and patient heterogeneity. Prospective multicentre cohort study performed in 12 hospitals in three countries between 2012 and 2019. All consecutive pregnant women with recurrent PL (≥3 losses or 2 losses in the presence of at least one euploid foetal karyotype) or at least one IUFD. Eligible women may have undergone thrombophilia testing before conception, at the discretion of local providers. The possible assignment of women to treatments (such as LMWH) was not decided a priori but was determined based on the responsible provider's current practice. Aims of the study were: (i) to evaluate factors associated with pregnancy outcome; (ii) to compare clinical management strategies in women with and without a subsequent successful pregnancy; and (iii) to evaluate characteristics of women who may benefit from antithrombotic therapy. A propensity score matching method was used to balance the differences in baseline characteristics. A matched sample of 265 pregnant women was analysed, with all undergoing thrombophilia screening; 103 out of 119 (86.6%) with and 98/146 (67.1%) without thrombophilia were prescribed with LMWH and/or ASA. Overall, live-births were recorded in 204 cases (77%), PL or IUFD in 61 (23%) pregnancies. Logistic regression showed a significant interaction between thrombophilia and treatment with LMWH (P = 0.03). Findings from sensitivity analysis showed odds ratio (OR) for pregnancy loss in women with inherited or acquired thrombophilia in absence of any treatment was 2.9 (95% CI, 1.4-6.1); the administration of LMWH (with or without ASA) was associated with higher odds of live-birth (OR, 10.6; 95% CI, 5.0-22.3). Furthermore, in women without thrombophilia, the odds of live-birth was significantly and independently associated with LMWH prophylaxis (alone or in association with ASA) (OR, 3.6; 95% CI, 1.7-7.9). While the propensity score matching allows us to balance the differences in baseline characteristics, it does not eliminate all confounding. Antithrombotic prophylaxis during pregnancy may be effective in women with otherwise unexplained PL or IUFD, and even more useful in those with thrombophilia. The study was funded by Italian Ministry of Health (Ricerca Corrente 2018-2020). Dr G.P. has received research grant support from Bristol Myers Squibb/Pfizer Alliance, Janssen, Boston Scientific Corporation, Bayer, and Portola and consultant fees from Amgen and Agile Therapeutics. Dr E.G. has received consultant fees from Italfarmaco and Sanofi. All other authors declare that they have no conflict of interest. NCT02385461.

GLP-1 RA and atrial fibrillation in the cardiovascular outcome trials.

Type 2 diabetes is known as an independent risk factor for atrial fibrillation. While glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have demonstrated multiple cardiovascular effects, including decrease in blood pressure and total cholesterol, their use was associated with an increase in heart rate. Furthermore, in a participant level meta-analysis evaluating albiglutide in the Harmony program, there were more participants who had atrial fibrillation or atrial flutter in the albiglutide-treated group. This has raised a concern about the use of GLP-1 RAs in individuals with type 2 diabetes who are at risk for developing atrial fibrillation. The cardiovascular outcome trials (CVOT) comparing GLP-1RA to placebo in individuals with type 2 diabetes and reported the incidence of atrial fibrillation as a serious adverse event were included. The primary outcome was to explore the incidence of atrial fibrillation reported as a serious adverse event. We included LEADER, SUSTAIN-6, REWIND, HARMONY, ELIXA, and PIONEER-6. While EXCSEL met our initial inclusion criteria, the incidence of atrial fibrillation was not reported as a serious adverse event. Pooled results showed no significant difference between GLP-1RA and placebo on the incidence of atrial fibrillation in individuals with type 2 diabetes (RR [95% CI] = 0.93 [0.70, 1.23], I²=58%) CONCLUSION: This review suggests that there was no significantly increased risk of incident atrial fibrillation in individuals treated with GLP-1 RAs when compared to placebo, among individuals with type 2 diabetes who either have increased cardiovascular risk or established cardiovascular disease. This article is protected by copyright. All rights reserved.

A Multicenter, Randomized, Sham-Controlled Trial of Left Prefrontal, 10 Hz, Transcranial Magnetic Stimulation for Adolescents with Treatment Resistant Depression.

Background: The objective of this study was to examine the feasibility, safety, and efficacy of 10 Hz repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder in adolescents. Methods: Adolescent subjects with treatment resistant depression (n=103) aged 12-21 were enrolled in multicenter, randomized, sham-controlled trial of rTMS. Inclusion criteria included a score of 2 or more on item 1 of the Hamilton Depression Rating Scale (HAMD-24) a total score of 20 or greater. Treatment resistance was defined as an ATR level of 1-4 in a current, discrete episode of depression. Subjects were randomized to either active NeuroStar TMS Therapy (n=48) or sham rTMS (n=55) for 30 daily treatments over 6 weeks as monotherapy. The primary outcome measure was the HAMD-24. Results: There were no baseline differences in demographics among the two arms. After 6 weeks of blinded treatment the LS mean (SE) HAMD-24 changes were 11.1 (2.03) in the active group and 10.6 (2.00) in the sham group with no statistically significant difference (p= 0.8, 95% CI -0.5 [-4.2, 3.3]). The response rate was 41.7% in the active group and 36.4% in the sham group (p= 0.6). The tolerability and safety findings were similar to existing adult data. Conclusions: Based on the largest study of adolescents to date, Left prefrontal 10 Hz rTMS monotherapy appears to be feasible, tolerable, and safe in adolescents with treatment resistant depression. Future studies should focus on study designs to reduce placebo response rates, larger sample size, and dose finding approaches for adolescents with depression. Funding: The study was funded by Neuronetics Disclosures: Dr. Croarkin has received research grant support from the National Institute of Mental Health, Brain and Behavior Research Foundation, and Pfizer, Inc. He has received equipment support from Neuronetics, Inc. and received supplies and genotyping services from Assurex Health, Inc. for investigator-initiated studies. He is the primary investigator for a multicenter study funded by Neuronetics, Inc. and a site primary investigator for a study funded by NeoSync, Inc. Dr. Croarkin has served as a paid consultant for Procter & Gamble Company and Myriad Neuroscience. Dr. Elmaadawi receives research support from Duke University and University of North Western. He receives research fund from Neurocrine, Inc and Neuronetics, Inc. He is also a speaker for Neuronetics, Inc. Dr. Aaronson has received research support from Compass Pathways and Neuronetics. He serves as a consultant to LivaNova, Neuronetics, Janssen, Genomind, and Sage Therapeutics. He is also on the speaker boards for Janssen and Sunovion. Dr. Schrodt has had consultation fees from Neuronetics. Dr. Holbert has received equipment support from Neuronetics, Inc. Ms. Verdoliva is an employee of NAMSA. NAMSA provides testing, consulting, and contract medical research services to the medical device industry. Ms. Heart is an employee of Neuronetics. Dr. Demitrack is a consultant to Neuronetics, Inc. and a full-time employee of Trevena, Inc. Dr. Strawn has received research support from Allergan, Neuronetics, Otsuka, the National Institutes of Health (National Institute of Mental Health, National Institute of Child Health and Development and National Institute of Environmental Health Sciences) and the Yung Family Foundation. He receives royalties from Springer Publishing and received honoraria from CMEology and Neuroscience Educational Institute. He receives royalties from UpToDate. Finally, he received material support from and provided consultation to Myriad Genetics.

Editorial introductions

Editorial introductions

The ovarian sensitivity index is predictive of live birth chances after IVF in infertile patients.

STUDY QUESTIONDoes the ovarian sensitivity index (OSI) predict embryo quality, pregnancy and live birth in patients undergoing FSH/hMG stimulation for IVF?SUMMARY ANSWERThe OSI is predictive of pregnancy and live birth in older women with a more unfavorable prognosis undergoing FSH/hMG stimulation for IVF.WHAT IS KNOWN ALREADYThe OSI was previously reported to reflect gonadotrophin requirements among high, normal and poor responders and to predict pregnancy potential in younger patients undergoing ovarian stimulation with FSH.STUDY DESIGN, SIZE, DURATIONA retrospective cohort study that included 1282 women undergoing IVF with FSH/hMG stimulation was carried out between January 2010 and December 2016.PARTICIPANTS/MATERIALS, SETTING, METHODSWe evaluated 1282 women who underwent fertility treatment with FSH/hMG stimulation and oocyte retrieval at an academically affiliated private fertility center. OSI was calculated as (oocytes ×1000)/total gonadotrophin dose and grouped into two classes based on a receiver operating characteristic (ROC) curve analysis of a randomly selected development sample comprising one-third of the cycles. The remaining cycles comprised the validation group. ROC curves were also used to compare the predictive value of OSI to that of baseline FSH and anti-Müllerian hormone (AMH). Logistic regression models evaluated the effect of high (OSI >0.83) and low (OSI ≤0.83) on clinical pregnancy and live birth in the validation group. Models were adjusted for female age, baseline FSH, AMH and oocyte yield and gonadotrophin dose.MAIN RESULTS AND THE ROLE OF CHANCEWomen presented with a mean ±SD age of 38.6 ± 5.4 years and showed median AMH levels of 0.65 (95% CI 0.61–0.74) ng/ml. They received 5145 ± 2477 IU of gonadotrophins and produced a median 5.2 (95% CI 5.0–5.5) oocytes. Pregnancy and live birth rates per oocyte retrieval for all women were 20.6% and 15.8%, respectively. Patients with higher OSI (less gonadotrophin required per oocyte retrieved) produced significantly more high-quality embryos than patients with low OSI (3.5 (95% CI 3.2–3.8) versus 0.6 (95% CI 0.5–0.7) (P = 0.0001)) and demonstrated higher pregnancy (23.2% versus 9.7%) and live birth rates (8.8% versus 5.3%) than their counterparts (P = 0.0001 and P = 0.0001, respectively). After adjustments for age, baseline AMH and FSH, total gonadotrophin dosage and oocyte yield, an OSI >0.83 was associated with greater odds of pregnancy (odds ratio 2.12, 95% CI 1.30–3.45, P < 0.003) and live birth (odds ratio 1.91, 95% CI 1.07–3.41, P < 0.028).LIMITATIONS, REASONS FOR CAUTIONThe results may not be applicable to women with excellent pregnancy potential or FSH-only stimulation.WIDER IMPLICATIONS OF THE FINDINGSThe predictive capacity of OSI for embryo quality, pregnancy and live birth, which is independent of AMH or FSH, may help in counseling patients about their pregnancy potential and live birth chances.STUDY FUNDING/COMPETING INTEREST(S)Intramural funding from the Center for Human Reproduction and the Foundation for Reproductive Medicine. A.W., V.A.K., D.F.A., D.H.B. and N.G. have received research grant support, travel funds and speaker honoraria from various pharmaceutical and medical device companies: none, however, related to the topic presented here. D.H.B. and N.G. are listed as inventors on already awarded and still pending US patents, claiming beneficial effects on diminished ovarian reserve and embryo ploidy from dehydroepiandrosterone supplementation.TRIAL REGISTRATION NUMBERN/A.

Anti-CD20 immunosuppressive disease-modifying therapies and COVID-19

Anti-CD20 immunosuppressive disease-modifying therapies and COVID-19

Impact and Effectiveness of 13-Valent Pneumococcal Conjugate Vaccine on Population Incidence of Vaccine and Non-Vaccine Serotype Invasive Pneumococcal Disease in Blantyre, Malawi, 2006-2018: Prospective Observational Time-Series and Case-Control Studies

Background: Population impact of pneumococcal conjugate vaccines (PCV) depend on direct and indirect protection. Following Malawi’s 2011 introduction of the 13-valent PCV (PCV13), we examined impact on vaccine serotype (VT) and non-VT (NVT) invasive pneumococcal disease (IPD) among vaccine-age-eligible and vaccine-age-ineligible children and adults. Methods: Laboratory-based surveillance at a government hospital in Malawi included 6 years before and 7 years after PCV13 introduction. Using negative-binomial regression, we evaluated secular trend-adjusted Incidence Rate Ratio (IRR) in VT- and NVT-IPD prior to and post PCV introduction. We compared predicted counterfactual incidence in hypothetical absence of vaccine with empirically observed incidence following vaccine introduction. A case-control study assessed vaccine effectiveness compared PCV uptake among vaccine-age-eligible IPD cases versus matched community controls. Findings: Surveillance covered 10 281 476 person-years observation, with 140 498 blood and 63 291 cerebrospinal fluid cultures. IPD decline preceded PCV introduction. Compared to the counterfactually predicted incidence, post-vaccine VT-IPD incidence was 38% (95%CI: 37, 40) lower among infants, 74% (70, 78) among young children, 79% (76, 83) among older children and 47% (44, 51) among adolescents and adults. Though NVT-IPD has increased since 2015 , absolute rates remain low. The case-control study, (19 cases and 76 controls), showed vaccine effectiveness against VT-IPD of 80·7% (-73·7, 97·9). Interpretation: Even with pre-existing declines, infant PCV13 introduction has led to substantial IPD reduction among vaccine-age-eligible children. However, seven years after PCV introduction, indirect effects benefitting unvaccinated infants and adults were more modest. Policy decisions should consider alternative strategies, including targeted vaccination outside infant EP to benefit vulnerable populations. Funding Statement: This work was funded by Bill & Melinda Gates Foundation, USA (OPP117653) to RSH and a Wellcome Trust Programme Grant (WT091909/B/10/Z) to NF, NAC, RSH; National Institute for Health Research (NIHR) Global Health Research Unit on Mucosal Pathogens using UK aid from the UK Government (Project number 16/136/46) to RSH. The MLW Clinical Research Programme is supported by a Strategic Award from the Wellcome Trust, UK (206545/Z/17/Z) to SG. Declaration of Interests: NBZ, NAC & NF have received investigator-initiated research grants from GlaxoSmithKline Biologicals. NBZ & NAC received investigator-initiated research grants from Takeda Pharmaceuticals. NAC has received research grant support and honoraria for participation in rotavirus vaccine advisory board meetings from GlaxoSmithKline Biologicals. All other authors declare no competing interests. Ethics Approval Statement: The study protocol was approved by Malawi’s National Health Sciences Research Committee (NHSRC; protocol 867), by the University of Malawi College of Medicine Research and Ethics Committee (COMREC; P.01/08/609 and P.09/09/826) and the University of Liverpool Research Ethics Committee (UoLREC; RETH490). The Centers for Disease Control and Prevention relied on the UoLREC for ethical approval. For the case-control component, the parent/guardian of all child participants provided written informed consent and, in addition, children 8 years or older provided written informed assent. This included consent for publication.

543-P: A Clinical, Proteomics and Artificial Intelligence-Driven Model to Predict Acute Kidney Injury in Diabetic Patients Undergoing Coronary Angiography—Results from the Catheter Sampled Blood Archive in Cardiovascular Diseases Study

Background: We previously developed a clinical/proteomics panel for predicting procedural acute kidney injury (AKI) and now examine its performance in those with diabetes (DM). Methods: We measured 109 biomarkers in blood from patients undergoing coronary angiography. Procedural AKI defined as increase in serum creatinine ≥0.3 mg/dL, increase in serum creatinine of ≥50%, or documented oliguria ≤7 days after procedure. Clinical and biomarker predictors of AKI identified using least-angle regression; a final prognostic model was developed with LASSO; the model was then measured in those with DM. Results: Besides DM, 5 predictors were in the final model: 3 (blood urea nitrogen to creatinine ratio, C-reactive protein and osteopontin) had positive association, while 2 (CD5 antigen-like and Factor VII) had negative association with AKI risk. Among 217 patients with DM, 18 (8.3%) developed AKI. The final model had an AUC of 0.87 for predicting procedural AKI (P&amp;lt;0.001). The optimal score cut-off had 100% sensitivity and a negative predictive value (NPV) of 100% for procedural AKI. Conclusions: We describe a clinical and proteomics-supported biomarker model with high sensitivity/NPV for AKI in patients with DM following coronary angiography. Disclosure N.E. Ibrahim: Other Relationship; Self; Novartis Pharmaceuticals Corporation. C.P. McCarthy: None. S. Shrestha: None. H. Gaggin: Other Relationship; Self; Dr. Gaggin has received research grant support from Roche Diagnostics, Jana Care, Ortho Clinical, Novartis; consulting income from Merck, Roche Diagnostics; research payments for clinical endpoint com. R. Mukai: None. C.A. Magaret: Consultant; Self; Prevencio. R.F. Rhyne: Board Member; Self; Prevencio. Employee; Self; Prevencio. Stock/Shareholder; Self; Prevencio. J. Januzzi: Consultant; Self; Abbott, Roche Diagnostic USA. Research Support; Self; Abbott, Prevencio, Quest Diagnostics, Roche Diagnostic USA. Funding Prevencio, Inc.

Prevalence and Cost of Subsequent Fractures Among U.S. Patients with an Incident Fracture.

The prevalence and cost of subsequent fractures among patients with an incident fracture are not well defined. To assess the prevalence of, and costs associated with, subsequent fractures in the year after an incident fracture. This was a retrospective claims database analysis using data from Humana Medicare Advantage claims (Medicare group) and Optum Insight Clinformatics Data Mart commercial claims (commercial group). Patients included in the study had a claim for a qualifying fracture occurring between January 2008 and December 2013 (index fracture), were continuously enrolled in the health plan for ≥ 1 year before and after the index fracture, and were aged ≥ 65 years in the Medicare group or ≥ 50 years in the commercial group at the time of the index fracture. Subsequent fractures were identified by ICD-9-CM codes and were defined as the second fracture occurring ≥ 3 to ≤ 12 months after the index fracture (≥ 6 to ≤ 12 months for fractures at the same site as the index fracture). Rates of subsequent fractures were calculated as the number of patients who had a subsequent fracture divided by the total sample size. After propensity matching of demographic and clinical variables, we determined the total medical and pharmacy costs accrued within 1 year of the index fracture by patients with and without a subsequent fracture. Health care costs were compared between patients with and without a subsequent fracture using McNemar's test. A total of 45,603 patients were included in the Medicare group, and 54,145 patients were included in the commercial group. In the Medicare group, 7,604 (16.7%) patients experienced a subsequent fracture. The proportion of patients with a subsequent fracture was highest among patients with multiple index fractures (26.2%, n = 905), followed by those with hip (25.5%, n = 1,280) and vertebral (20.2%, n = 1,908) index fractures. In the commercial group, 6,256 (11.6%) patients experienced a subsequent fracture. The proportion of patients with a subsequent fracture paralleled those observed in the Medicare group: 24.5% (n = 808) in patients with multiple index fractures, 22.0% (n = 525) in those with hip fracture, and 14.5% (n = 841) in those with vertebral fracture. For vertebral, hip, and nonhip nonvertebral fractures, subsequent fractures were most frequently of the same type as the index fracture. The mean total health care cost (sum of medical and pharmacy costs) in the year following the incident fracture for the Medicare group was $27,844 and differed significantly between patients with and without a subsequent fracture ($34,897 vs. $20,790; P < 0.001). The mean total health care cost in the year following the incident fracture for the commercial group was $29,316 and also differed significantly between patients with and without a subsequent fracture ($39,501 vs. $19,131; P < 0.001). Among patients with an incident fracture, those who experienced a subsequent fracture in the following year had significantly higher health care costs than those who did not. A subsequent fracture is most likely to be of the same type as the initial fracture. This study was funded by Merck & Co. Other than through the employer relationships disclosed here, Merck & Co did not have a role in the study design, data collection, interpretation of the data, in writing of the manuscript, or in the decision to submit the manuscript for publication. Weaver and Marvos are employees of Merck & Co. Sajjan was an employee of Merck & Co. and owned stock in the company at the time of the study. Lewiecki has received consulting and/or speaker honoraria from Merck, AbbVie, AgNovos Healthcare, Alexion Pharmaceuticals, Amgen, Eli Lilly and Company, Radius Health, Shire, and TheraNova. Lewiecki has received research grant support from Merck, Amgen, and Eli Lilly and Company and serves as a board member for the National Osteoporosis Foundation, the International Society for Clinical Densitometry, and the Osteoporosis Foundation of New Mexico. Harris has received consulting honoraria from Merck, Alexion Pharmaceuticals, Amgen, Eli Lilly and Company, Gilead Sciences, Primus Pharmaceuticals, and Radius Health. Study concept and design were contributed by Weave and Sajjan. Lewiecki collected the data, and data interpretation was performed by all the authors. The manuscript was written and revised by Weaver, Lewiecki, and Harris.

Estimating Generic Drug Use with Electronic Health Records Data from a Health Care Delivery System: Implications for Quality Improvement and Research

Generic drug use in the outpatient setting is typically measured with adjudicated pharmacy claims; however, not all delivery systems have access to these data for their clinical populations. To develop an algorithm to estimate generic drug use in an outpatient setting using electronic health records (EHR) data. Twenty-five therapeutic classes were chosen with the potential for low generic use that were prescribed to managed care beneficiaries in a health care system in Northern California. An algorithm was developed to estimate generic drug use based on medication names and dispense-as-written requests from electronic prescriptions, as well as information on generic availability at the time the prescriptions were written. The algorithm was used to quantify a generic utilization rate (GUR) across therapeutic classes and was validated by comparing the estimated GUR to the true GUR, using pharmacy claims corresponding to prescriptions in the same patient cohort. Among managed care beneficiaries, 104,859 prescriptions were identified for drugs in the therapeutic classes of interest with corresponding pharmacy claims. The algorithm estimated a GUR of 73.7% across 25 unique classes. The actual GUR based on pharmacy claims was 73.1%. Sensitivity (97%) and specificity (89%) of the algorithm were high, and total percentage of agreement was 95%. An algorithm that estimates generic drug use performed well in a population of managed care beneficiaries. Health care delivery systems may apply methods described in this article to quantify generic drug use in their ambulatory populations for quality improvement and research initiatives, particularly when pharmacy claims are unavailable. This study was funded by a grant from the U.S. Food and Drug Administration in cooperative agreement with the Johns Hopkins School of Medicine and the Palo Alto Medical Foundation Research Institute (1U01FD005267-01). Romanelli has received research grant support from Pfizer and Janssen Scientific Affairs. Authors have no other conflicts to disclose. Romanelli and Segal contributed the study concept and design. Nimbal took the lead in data collection, assisted by Romanelli. All authors were involved with data interpretation and revision of the manuscript. The manuscript was written by Romanelli and Nimbal.

Long-term surveillance of the effect of PCV13: the future challenge in Africa

Long-term surveillance of the effect of PCV13: the future challenge in Africa

Building the connections between science, practice and policy: Griffith Edwards and the UK National Addiction Centre

Building the connections between science, practice and policy: Griffith Edwards and the UK National Addiction Centre

Triglyceride-Lowering Therapies Reduce Cardiovascular Disease Event Risk in Subjects with Hypertriglyceridemia

Dr. Maki has received research grant support and consulting fees from AstraZeneca, as well as GlaxoSmithKline, AbbVie, Matinas Biopharma, Amarin, and Trygg Pharmaceuticals.

Another update. Red meat doesn’t kill you, but the spin is fascinating

Another update. Red meat doesn’t kill you, but the spin is fascinating

What’s Next for Somatic Symptom Disorder?

What’s Next for Somatic Symptom Disorder?