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The notary profession has surfaced as the result of social interactions which has since then created and developed by the said community. In carrying out their position, the notary is guided by the Notary Position Law (Undang-Undang Jabatan Notaris, UUJN) and the Code of Ethics by the Indonesian Notary Association. However, in practice, problems are often encountered in the duties and powers of a notary, especially in relation to honorarium. Until now, the provisions on honorarium have not stated in the exact amount or proportion, in that regards, problems of uncertainty often arise in determining the amount of honorarium which results in bargaining between the notary and the client. This is a normative research method. The results of this study conclude that the poor is able to obtain deed-making services without being charged an honorarium refers to people who cannot fulfill their fundamental needs which include the rights to food, clothing, health services, education services, work and business and/or housing properly and independently. In addition, the procedure for deed-making services without being charged an honorarium is not regulated in UUJN nor the Notary's Code of Ethics, but the notary determines it themselfKey Word: Notary, Legal Service, Honorarium AbstrakProfesi notaris terlahir karena adanya hasil interaksi antar masyarakat dan kemudian dikembangkan dan diciptakan oleh masyarakat itu sendiri. Dalam menjalankan jabatannya notaris berpedoman pada UUJN dan Peraturan Kode Etik Ikatan Notaris Indonesia. Namun dalam praktiknya sering dijumpai permasalahan pada tugas dan wewenang notaris terlebih terkait dengan honorarium. Ketentuan honorarium hingga saat ini belum menyebutkan jumlah atau proporsi yang pasti, karena hal tersebut di lapangan sering timbul permasalahan ketidak kepastian dalam penentuan besaran honorarium yang mengakibatkan terjadinya tawar-menawar antara notaris dengan klien. Penelitian ini menggunakan jenis metode penelitian normatif. Hasil penelitian ini menyimpulkan bahwa masyarakat tidak mampu yang bisa mendapatkan jasa pembuatan akta tanpa dipungut honorarium adalah orang yang tidak dapat memenuhi hak dasar yang meliputi hak atas pangan, sandang, layanan kesehatanm layanan pendidikan, pekerjaan dan berusaha dan/atau perumahan secara layak dan mandiri. Selain itu prosedur mengenai jasa pembuatan akta tanpa dipungut honorarium tidak diatur dalam UUJN ataupun Kode Etik Notaris, akan tetapi notaris menentikan sendiri barometer tersebut.Kata-kata Kunci: Notaris, Jasa Hukum, Honorarium

Hospital and healthcare administrators name high prescription drug costs as one of their largest problems. A significant body of research demonstrates that meals and honoraria from pharmaceutical firms to physicians leads to higher prescribing of expensive, brand name drugs, despite little difference in efficacy. Some administrators and scholars have advocated for mandatory disclosure of these payments in order to reduce this conflict of interest, but many practitioners believe disclosure has little effect on prescribing, and the empirical evidence is mixed. This paper uses a quasi-experiment of a 2009 payment disclosure policy in Massachusetts to estimate the causal impact of public disclosure on prescribing. The comprehensive data set includes all retail prescriptions for 262 drugs in nine drug classes written by 5,730 physicians in five states over 48 months. We show a significant postdisclosure reduction in brand name drug prescriptions by Massachusetts physicians, relative to control physicians in other states. These effects are driven by heavy prescribers of brand name drugs in the prepolicy period, particularly for drugs with large prepolicy sales forces. Effects are also detected before the first data were released, implying that the effects are not because patients or administrators responded to the disclosed payments. Instead, some physicians may have changed their payments and prescriptions behavior to avoid appearing biased. Taken in tandem with the many studies showing that pharmaceutical industry payments influence prescribing, this study suggests a strong role for mandatory public disclosure in reducing conflicts of interest in medicine and costly prescribing of brand name drugs. This paper was accepted by Stefan Scholtes, healthcare management.

In recent time, there has been an increased push toward transparency in industry funding toward physicians. The Physician Payments Sunshine Act called for the creation of the Open Payments Database managed by the Centers for MedicareMedicaid Services. To our knowledge, there have been no studies evaluating the trends in payments among adult reconstruction fellowship-trained orthopedic surgeons. The purpose of this study is to investigate trends in all payments to adult reconstruction-trained orthopedic surgeons from 2014 to 2019. Secondary outcomes included evaluating trends in yearly subpayment categories, regional variations, as well as characterizing the top 5 industry companies.A review of the Centers for MedicareMedicaid Services Open Payments Database was performed to identify all payments to adult reconstruction-trained orthopedic surgeons. A total of 94,265 payments were made to 4911 surgeons accounting for a total of $258,865,231.20 during the study period. Our primary outcome was to assess the trend in median payment per year to individual surgeons. Secondary outcomes included evaluating payment trends with respect to subtype, location as defined by United States Census regions, as well as specifics concerning the top 5 companies.Over the study period, there was a nonsignificant increasing trend in median payment per surgeon (r = 0.49, P = .096). However, there was also a significantly increasing trend in the number of payments per year (r = 0.83, P = .014), as well as the number of surgeons receiving payments (r = 0.88, P = .019). With respect to subcategory payments, there were significantly increasing trends in the median payment per surgeon for education (1054%, r = 0.942, P.001) and entertainment/food and beverage expenses (20.2%, r = 0.49, P = .020), as well as a significantly decreasing trend for median honoraria payments per surgeon (20.2%, r = -0.04, P = .005). No significant regional trends were identified. Of the top 5 companies, one demonstrated a significantly decreasing trend in median payment per surgeon (21.6%, r = -0.109, P.001), whereas the others remained unchanged.In this study, we found a nonsignificant increasing trend in payments to adult reconstruction-trained surgeons as well as an increasing number of surgeons receiving payments. There were increasing trends in median payment per surgeon for education and entertainment expenses, but a decreasing trend for honoraria payments. No significant regional trends were identified. The majority of the top 5 companies had nonsignificant trends in their payments. Further studies are needed to characterize the disclosure of payments and the impact of industry payments on clinical outcomes.IV.

Leadership Management in Improving Service Quality in private universities in Jambi Province which is the target of research is under the Regional Kopertais Environment of UIN Sulthan Thaha Saifuddin Jambi. The quality of service in an organization is the main focus, considering that services that can be carried out effectively and efficiently are a dream for all customers, and the goal of the organization itself. In this study, the researcher used a qualitative-naturalistic approach. Through this qualitative approach, it is hoped that an overview of leadership management and service improvement will be raised. The naturalistic approach demands data collection in a natural setting. The method used in collecting data in the field is the method of observation, interviews and documentation. The results of this study indicate that the implementation of service quality carried out by the Three Private STAIs in the Kopertais Region XIII Jambi City environment have both implemented the eight standards as specified in the planning. However, there is a very significant difference between Ashanta and Al-Azhar Private STAI and Al-Marif Private STAI. Of the three STAIs, the one that is superior is the Al-Ma'rif Private STAI, with evidence that can be seen from the number of students quite a lot, and the majority of the teaching staff are S2 qualified and some are even S3 qualified. When viewed from the satisfaction of service quality from customers, Al-Ma'rif Private STAI has the advantages of the three Private STAIs that are the targets of researchers, satisfaction indicators such as learning facilities and infrastructure are independent and have their own. In addition, the management of financing is more organized and transparent from the Foundation and the Chairperson of the Foundation to their subordinates. Payment of honorarium for staff and lecturers in accordance with the provisions specified and paid on time.

This research is motivated by the fact that at Al-Ittihad High School, there is a lack of awareness of students towards the practice of religion. This study aimed to determine the principal's program in planning, organizing, implementing, supervising, supporting, and inhibiting factors from improving the professionalism of teachers at Al-Ittihad High School. This research is qualitative descriptive field research. They are collecting data using interviews, observation, and documentation methods. Analysis of the data used is a qualitative analysis consisting of three components of analysis: data reduction, data presentation, and concluding. All three are carried out interactively with the data collecting process as one cycle. The results show that planning is done by improving the quality of teachers, continuing education to a higher level, providing adequate honorarium incentives, involving teachers in training, workshops, seminars, workshops, and so on.

This study aims to determine the implementation of withholding income tax article 4 paragraph 1 on honorarium and compensation for civil servants outside of salary at the BAPENDA BULUKUMBA. district office. This type of research is a qualitive descriptive study. Where research is carried out in the field and the survey is directly in place to be studied. Research Result Based on data obtained from the Bapenda of Bulukumba Regency and the data processing carried out by researchers according to the PPh 1984 Law that the income subject to taxatipn has the following elements, that what includes income is any addictional ability to control goods and service obtained by the taxpayer, the ratte of withholding income tax articel 4 paragraph 1.

The research aims to analyze the implementation of collection of land and building tax, optimization of PBB’s revenue and factors that influence the optimization of PBB’s revenue in Kelurahan Klaten, Kecamatan Klaten Tengah, Kabupaten Klaten. The method in this study uses a qualitative approach to the type of descriptive research. The data used are primary’s data and secondary’s data for 2015 - 2018. Primary’s data were obtained from direct interviews with stakeholders namely the apparatus or team of Land and Building Tax’s collection officers. Secondary’s data is taken from revenue’s data from the principal provisions of the PBB, the principal’s data on the provisions of PBB, and honorarium’s data of the PBB’s collection, the data are processed and processed using the formula of the ratio of effectiveness and efficiency. The results showed that the implementation of the Taxation of Land and Building Tax in Kelurahan Klaten had been run with a well-structured governance so that the revenue of the Land and Building Tax in 2015 - 2017 which was initially running quite optimally had increased in 2018 ie running optimally this was influenced by two good factors that come from the attitude of the apparatus or team of Land and Building Tax’s collection officers or awareness of taxpayers. Based on the results of the above understanding, the authors can provide suggestions related to efforts to increase optimization of PBB’s revenue that the Kelurahan Klaten in order to maximize the collection process through increasing counseling and hold a ball pick-up system every month, impose the application of policies for taxpayers through administrative requirements that require the inclusion of the PBB’s paid off in every service and punishment the sticking of a PBB’s sticker has not been paid off in every home. And the taxpayers are expected to have the awareness to pay taxes on time.

The background of this research is that there are still teachers who show low performance. The problems that have been identified include teacher honorarium allowances. Therefore the aim of this study was to determine the effect of teacher honorarium allowances on improving teacher performance at the Al Amanah Islamic Education Foundation, Cibinong, Bogor. The research method used is a quantitative method. The data collection technique used a questionnaire. The data analysis technique uses descriptive analysis, quantitative analysis and hypothesis testing. The results showed Teacher honorarium allowances (variable X) have a significant contribution and have a very high effect and the direction of a positive relationship to the variable increasing teacher performance at the Al Amanah Education Foundation, Cibinong, Bogor is 74.5% and 25.5% increase in teacher performance is influenced by other factors.

One of the activities at Ma'soem University is the Registration of Final Projects for Diploma Three (D3) students and Thesis for Undergraduate students (S1). Currently, the registration process for the Final Project and Thesis is still done manually, where students must come directly to the campus to register, pay and fill out the title submission form. Meanwhile, for the preparation of seminar schedules, honoraria and final and thesis report, data processing is still using Ms. Excel. From these activities, several obstacles were found regarding information on Final Projects and Thesis, including: 1. Limited payment and registration services for Final Projects and Thesis, which can only be served on campus during working hours and days from Monday to Saturday 07.30 to 21.30 WIB. 2. Filling in the Final Project and Thesis forms manually, there is a risk of damage and loss of data. 3. Do not have a database yet, so that it is difficult to validate data on the same Final Project Title and Thesis submitted by students. 4. The process of making seminar and final project honorarium reports and thesis sessions takes a long time, and cannot be generated automatically. In this study, the system development method used is the OOAD (Object Oriented Analysis and Design) method with the RUP (Rational Unified Process) model, which consists of several stages, namely: Business Modeling, Requirments, Analysis and Design, Implementation, Test, Deployment. As for the system development tools using UML (Unified Modeling Language) which consists of: Use Case Diagrams, Activity Diagrams and Class Diagrams. With the design of the information system architecture of this Final Project and Thesis, it produces a blueprint that can: Provide payment and registration services for Final Projects and Theses that are not limited by space and time, minimize the occurrence of damage and data loss, make it easier to validate submissions for the title of Final Project the same and can facilitate the process of making seminar and final project honorarium reports and thesis reports so that they can be generated automatically.

The implementation of government procurement of goods / services through e-tendering in Indonesia is still experiencing several problems. As with the implementation of e-tendering at the Regional Procurement Service Unit of the Ministry of Finance of South Sulawesi Province, which experienced a failed tender. In 2016, the number of failed tenders was as many as six failed tender packages amounting to IDR 4,695,581,000.00. Then in 2017, the number of tender packages failed as many as four packages amounting to IDR 36,531,445,000.00. In 2018, four packages experienced failed tenders valued at IDR 23,407,124,000.00. Until August 2019, there were two failed tenders with a value of IDR 2,061,932,000.00. In addition, there are still suppliers' conspiracy to participate in tenders. This study aims to evaluate the implementation of E-Tendering at the Regional Procurement Service Unit of the Ministry of Finance of South Sulawesi Province using a qualitative descriptive approach through interviews, observation and documentation study. The results showed that there was a delay in the completion of the tender, and the implementation of the reverse auction was not in accordance with the provisions. Adequacy of costs and results in the implementation of e-tendering has been fulfilled and there is also an even distribution of activities and benefits for all parties directly involved in the e-tendering process. The satisfaction of the parties in implementing e-tendering is the ease of system access, open competition and processes, and the ability to reduce workloads. Network maintenance that interferes with the tender schedule, the fairness of the Pokja ULPD honorarium, and the process of providing an explanation are not in accordance with the provisions. The implementation of e-tendering at the Regional Procurement Service Unit of the Ministry of Finance of South Sulawesi Province has been carried out quite well but there are still several things that need to be addressed, including the ad hoc status of the ULPD Working Group, competency of the parties, coordination between PPK and Pokja ULPD, network maintenance, fairness of value. honorarium for Pokja ULPD, and implementation of the stages of giving explanations..

RESUMEN. Desde una novedosa perspectiva de estudios romanísticos propia de la primera mitad del siglo xx, en este artículo el eminente romanista Salvatore Riccobono nos ilustra de manera magistral con su método crítico sobre los grandes momentos y desarrollos del sistema jurídico romanístico, para concluir que el Corpus luris de Justiniano fue el producto de la tradición del derecho romano y no de la influencia helenística. Los tres elementos jurídicos propios de la tradición romanística: ius civile, ius honorarium, ius gentium, se destacan en su relación con los juristas, la tarea de la jurisprudencia romana, y la actividad del pretor basada en la equidad. Es grato presentar esta traducción casi un siglo después. ABSTRACT. In this article, the eminent Romanist Salvatore Riccobono masterfully illustrates, from a perspective of Romanistic studies typical of the first half of the 20th century, about the great moments and developments of the Roman law legal system tradition, to conclude that Justinian's Corpus luris was the product of the tradition of Roman law and not of the Hellenistic influence. The three legal elements typical of the Roman law tradition: ius civile, ius honorarium, ius gentium, stand out in their relationship with jurists, the task of Roman jurisprudence, and the activity of the Praetor based on equity.

BACKGROUND: Multiple barriers exist for appropriate use of the proprotein convertase subtilisin/kexin type 9 enzyme inhibitors (PCSK9i) in patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) with inadequately controlled hypercholesterolemia despite standard therapies. Among these barriers, high payer rejection rates and inadequate prior authorization (PA) documentation by providers hinder optimal use of PCSK9i. OBJECTIVES: To (a) identify and discuss provider and payer discordances on barriers to authorization and use of PCSK9i based on clinical and real-world evidence and (b) align understanding and application of clinical, cost, safety, and efficacy data of PCSK9i. METHODS: Local groups of 3 payers and 3 providers met in 6 separate locations across the United States through a collaborative project of AMCP and PRIME Education. Responses to selected pre- and postmeeting survey questions measured changes in attitudes and beliefs regarding treatment barriers, lipid thresholds for considering PCSK9i therapy, and tactics for improving PA processes. Statistical analysis of inter- and intragroup changes in attitudes were performed by Cox proportional hazards test and Fisher's exact test for 70 mg/dL for patients with ASCVD (78%-83% and 44%-67%, respectively) or FH (22%-39% and 22%-33%). Payers were more agreeable to less stringent PA requirements for patients with FH (33%-72%, P = 0.019) and need for standardized PA requirements (50%-83%, P = 0.034); these considerations remained high (89%) among providers after the meeting. Most participants supported educational programs for patient treatment adherence (83%) and physician/staff PA processes (83%-94%). CONCLUSIONS: Provider and payer representatives in 6 distinct geographic locations provided recommendations to improve quality of care in patients eligible for PCSK9i. Participants also provided tactical recommendations for streamlining PA documentation processes and improving awareness of PCSK9i cost-effectiveness and clinical efficacy. The majority of participants supported development of universal, standardized patient eligibility criteria and PA forms. DISCLOSURES: The study reported in this article was part of a continuing education program funded by an independent educational grant awarded by Sanofi US and Regeneron Pharmaceuticals to PRIME Education. The grantor had no role in the study design, execution, analysis, or reporting. AMCP received grant funding from PRIME to assist in the study, as well as in writing the manuscript. McCormick, Bhatt, Bays, Taub, Caldwell, Guerin, Steinhoff, and Ahmad received an honorarium from PRIME for serving as faculty for the continuing education program. McCormick, Bhatt, Bays, Taub, Caldwell, Guerin, Steinhoff, and Ahmad were involved as participants in the study. Bhatt discloses the following relationships: Advisory board: Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Level Ex, Medscape Cardiology, PhaseBio, PLx Pharma, Regado Biosciences; Board of directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data monitoring committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research funding: Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); Site co-investigator: Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded research: FlowCo, Merck, Novo Nordisk, Takeda. Bays' research site has received research grants from 89Bio, Acasti, Akcea, Allergan, Alon Medtech/Epitomee, Amarin, Amgen, AstraZeneca, Axsome, Boehringer Ingelheim, Civi, Eli Lilly, Esperion, Evidera, Gan and Lee, Home Access, Janssen, Johnson and Johnson, Lexicon, Matinas, Merck, Metavant, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi, Selecta, TIMI, and Urovant. Bays has served as a consultant/advisor for 89Bio, Amarin, Esperion, Matinas, and Gelesis, and speaker for Esperion. McCormick, Caldwell, Guerin, Ahmad, Singh, Moreo, Carter, Heggen, and Sapir have nothing to disclose.

Background: Autoimmunity may play a role in idiopathic pulmonary arterial hypertension (IPAH). It is not clear if this is causative, or as a bystander of disease and if it carries any prognostic or treatment significance. Methods: Comprehensive immune phenotyping was performed in IPAH patients, utilising patient samples from the UK National cohort study of Idiopathic and Heritable PAH. Standardised flow cytometric analysis of peripheral blood mononuclear cell types was assessed in IPAH patients and healthy controls. Serum autoantibody biomarkers were assayed using a Protoplex™ autoimmune panel in 473 type I PAH patients and 946 matched controls. Finally, a GST-fusion human proteomic screen was undertaken to identify novel circulating autoantibodies in PAH, and 350 PAH sera samples ELISA assayed for a putative antibody to BMPR2. Findings: Flow cytometric immune profiling demonstrates IPAH is associated with a signature consistent with altered humoral immune response. Increased autoantibody positivity was detected in PAH and patient subgroups associated with worse haemodynamic parameters but better overall survival. We identify a small subset of PAH patients who demonstrate immunoglobulin reactivity to the extracellular domain of the TGFbeta superfamily receptor, BMPR2, a protein which is strongly associated with hereditary causes of the disease. Interpretation: This evidence strongly suggests a proportion of patients with IPAH have an autoimmune component to the disease and that the BMPR2 pathway may be a target. Future trials targeting inflammation need to consider biomarker stratification. Funding Information: NIHR BRC, The Dinosaur Trust, MRC (MC_UU_00002/4) and the Wellcome Trust [WT107881]. Declarations of Interest: Gerry Coghlan reports grants and personal fees for conference attendance from Johnson & Johnson, personal fees for lectures from GlaxoSmithKline, Bayer and MSD, outside the submitted work. Paul Corris reports grants and personal fees for lectures and consultations from Actelion and Bayer, and personal fees for lectures and consultations from MSD, outside the submitted work. Luke Howard reports grants, personal fees for lectures, steering committee and advisory board work, and non-financial support for meeting attendance from Actelion, personal fees for lectures and advisory board work from Bayer and MSD, personal fees for advisory board work from GSK, outside the submitted work. Martin Johnson reports grants and personal fees for meeting attendance, lectures, and advisory board work from Actelion and MSD, outside the submitted work. David Kiely reports grants, personal fees, and other support from Actelion, Bayer and GSK, and personal fees and other support from MSD, outside the submitted work. Allan Lawrie reports grants from British Heart Foundation and Medical Research Council, grants, personal fees, and travel support from Actelion Pharmaceuticals Ltd, grants and personal fees from GlaxoSmithKline, outside the submitted work. James Lordan has received modest honoraria from Actelion and modest support to attend conference from Merck Sharp & Dohme, outside the submitted work. Joanna Pepke Zaba received fees for research grant, support to travel to meetings and honoraria from Actelion, Bayer, GlaxoSmithKline and Merck Sharp & Dohme, outside the submitted work. S.John Wort has received modest honoraria from GlaxoSmithKline, Actelion and Bayer and has received significant research grants from Actelion and Bayer, outside the submitted work. Nicholas Morrell reports personal fees from GSK and Johnson & Johnson/Actelion, outside the submitted work. Mark Toshner reports personal fees from GSK, grants and personal fees from J&J/Actelion, grants from Merck and Bayer, outside the submitted work. All other authors have nothing to disclose Ethics Approval Statement: Ethical approval was obtained, and informed written consent was given. For collection and processing of samples for autoantibody analysis, including controls ethical approval was obtained (An integrated approach to dissect the determinants, risk factors and pathways of ageing in the immune system 15/EE/0327, IRAS # 188383 and Genetics and epidemiology of aging-associated conditions in the Sardinian population, ProgeNIA PROT 2171/CE).

Objectives Residents receiving industry payments are not legally required to be reported on the Centers for Medicare & Medicaid Services (CMS) Open Payments Database. The purpose of this study is to review reporting of orthopedic surgery residents and identify the trends for which payments or transfers in value were received. Design The CMS Open Payments Database was used to search for all available orthopedic residents from 2014 to 2016. All data available on the CMS Open Payments Database was recorded. Setting/Participants This is a database study. Participants are residents reported in the CMS Open Payments Database. Results Over the 3-year period, 6832 resident “entities” were identified from 151 programs. A total of 3217 entities (47%) were reported as receiving payments from industry during this time period. This totaled $3,786,754 over the 3 year study period. The largest itemized categories for payment were education (32.5%) and grants (30.9%) totaling more than $2.4 million. Other areas of payment included travel (17.0%), food (16.0%), consultation fee (1.7%), research (0.8%), speaker fee (0.7%), gift (0.1%), honoraria (0.1%), and other (0.02%). Conclusion Overall, 47% of orthopedic resident entities were reported on the CMS Open Payments Database. The vast majority of payments were related to education and grants. Residents should become familiar with how to navigate the Open Payments Database and be educated on maintaining appropriate relationships with industry.

The Law on Notary Position (hereafter called UUJN) states the honorarium, but in practice, it has certain limits. The uncertainty of honoraria can lead to misunderstanding between the notary and the client. This research was conducted with the aim of revealing whether the determination of the economic value of each deed in the practice of implementing the position of a notary is in accordance with the provisions of the UUJN and whether a notary can provide legal services in connotarial matters to underprivileged people. This research was designed using juridical-empirical research methods. The results of this study indicated that the determination of the economic value of each deed in the practice of implementing the position of a notary is in accordance with the provisions of UUJN as stipulated in article 36. All public officials who have agreed on the arrangement of the honorarium state that they must have a sense of binding and the existence of coercive power which is adjusted to the provisions in UUJN. In addition, a notary can provide legal services in the field of connotarization to underprivileged people based on a notary's morality and integrity. This is supported by Article 37 of the UUJN which states that notaries are required to provide services free of charge to people who cannot afford it.

The purpose of this study was to analyze the Notary's honorarium for legal services in making authentic deeds. Notary is one of the professions in the legal field, which provides legal services for citizens in terms of making authentic deeds. Every authentic deed made, of course, a notary as a legal service provider is entitled to receive an honorarium. This research is a normative juridical study, with a descriptive approach. In this research, it is further studied regarding the Notary's honorarium for legal services in making authentic deeds. In accordance with the provisions in Article 36 paragraph (2) UUJN, Notary fees for legal services in making authentic deeds are based on the economic value and sociological value of the deed that has been drawn up. In Article 36 paragraph (3) of the JN Law, it is determined that the economic value is determined from the object of each deed. Thus, the Notary's honorarium is important for legal services as an authentic deed maker.

Tujuan dari penelitian ini adalah untuk mengetahui bagaimana sistem pengelolaan wakaf produktif tanah sawah di Yayasan Islam Pondok Pesantren Miftahul Jannah Jatibaru Kecamatan Jatisari Karawang, dan bagaimana penyaluran hasil dari pengelolaan wakaf produktif tanah sawah di Yayasan Islam Pondok Pesantren Miftahul Jannah. Jenis penelitian yang digunakan adalah penelitian lapangan (field research), adapun pendekatan yang digunakan dalam penelitian ini adalah pendekatan deskriptif-kualitatif. Nadzir sebagai pengelola wakaf dalam rangak melindungi aset harta wakaf, nadzir melakukan pembuatan Akta Ikrar Wakaf (AIW) ke PPAIW supaya mempunyai kekuatan hukum sesuai dengan peraturan perundang-undangan. Nadzir dalam mengelola wakaf tanah sawah dengan cara disewakan dan dalam penentuan penyewaannya menggunakan sistem sewa pertahun (model sewa jangka panjang dan hukr), dalam prinsip pembayarannya secara langsung atau tunai untuk jangka waktu satu tahun. Pengelola wakaf belum pernah melaporkan pengelolaan wakaf kepada pihak pemerintah atau pihak terkait dikarenakan tidak mengerti jalur atau tata cara pelaporannya. Dalam pola pengelolaannya masih termasuk dalam pola pengelolaan wakaf tradisional konsumtif. Hasil dari pengelolaan wakaf tanah sawah di peruntukan untuk operasional pondok pesantren dan untuk perbaikan atau renovasi ringan di pondok pesantren, dengan pembagian 50% untuk perbaikan atau renovasi ringan pondok pesantren dan 50% untuk biaya operasional pondok pesantren. Biaya operasional dibagi diperuntukannya 75% untuk honor dewan guru dan 25% untuk kebutuhan ATK (Alat Tulis Kantor).

This study aimed at determining the planning and accountability as well as the benefits and impacts of the BOS funding program in SD Negeri 01 Pulau Rimau, Banyuasin. The data sources of this research were the principal, teachers and students of SD Negeri 01 Pulau Rimau. The method used qualitative and applied interviews, documentation and observation as instruments. The results showed that 1) BOS program planning was realized in the RAPBS; 2) the use of BOS funds has been carried out in accordance with the 2015 National Technical Guidelines used by schools; 3) accountability of BOS funds in the form of memorandum of purchase and maintenance of equipment as well as for payment of teacher honoraria at schools; 4) and the benefits and impacts of the BOS program for schools is that the learning process runs effectively by always improving the quality of facilities.

Background: The problem of the uneven distribution of medical services is drawing much attention worldwide. To reveal how the changes in the specialty training system affected the distribution of doctors in Japan can help us understand this problem. In 2018, a new and standardized specialty training system was implemented by the Japanese Medical Specialty Board, which is recognized by the Ministry of Health, Labor and Welfare. The purpose of this study was to investigate how this has affected the geographical distribution of doctors commencing specialty training (trainees) and choice of specialty in Japan. Methods: Change in the number of trainees between the control period (2012 to 2014) and 2018 was investigated, taking into account prefecture and specialty selected. Population, aging rate, and total number of overall doctors in each prefecture were considered as the background characteristics of each prefecture. The Gini coefficient was used to determine evenness of trainees' distribution. Findings: In 2018, the number of trainees per 100,000 population showed an increase to 6.6 nationwide compared with 5.5 during the control period. The number of trainees per 100,000 population in 2018 showed an increase in prefectures with a large population of ≧ 2,000,000, a low aging rate (< 27%), and a high doctor density (≧ 250 doctors per 100000 population). The Gini coefficient showed an increase to 0.226 in 2018 compared with only 0.160 during the control period. The total number of trainees and that per 100,000 population showed an increase in all specialties. Interpretation: After the implementation of the new training system, the number of doctors enrolling in specialty programs showed an increase. Inequality of distribution urban and rural prefectures worsened, however, indicating the need to explore ways of balancing unevenness of distribution while maintaining optimal opportunities for specialist training. Funding Statement: The authors state: "This research isn’t receiving any funding." Declaration of Interests: Dr. Saito reports honorarium from TAIHO Pharmaceutical Co., Ltd., outside the submitted work. Ethics Approval Statement: The authors state: "Not applicable."

Pada kantor Advokat Buyung & Partners memiliki kendala terkait berkas perkara yang semakin hari semakinbanyak yang dapat menimbulkan tertukarnya berkas, beberapa data penting yang hilang, berkas rusak dansebagainya. Sistem ini membahas tentang pengarsipan berkas – berkas perkara. Ada juga kendala dalampenjadwalan Advokat pendamping sidang. Dua unsur diatas adalah bagian terpenting dalam pengelolaan perkara hukum. Maka dari itu dibuatlah Sistem Informasi yang dapat mengatasi kendala-kendala tersebut. Sistem penjadwalan Advokat pendamping sidang menjadi solusi yang efektif untuk mengatasi jadwal Advokat yang bentrok. Adanya notifikasi via email kepada Advokat dan Klien sebelum persidangan dianggap membantu kedua belah pihak untuk mempersiapkan diri sebelum maju ke persidangan di Pengadilan Negeri. Selain kedua fitur diatas, sistem ini juga membahas tentang keuangan yang dikelola di dalam kantor Advokat Buyung & Partners. Pengelolaan keuangan menyangkut tentang pembayaran biaya penanganan perkara oleh klien, pembagian honor Advokat dan pemasukan yang diterima oleh kantor.

Section 6002 of the Affordable Care Act, commonly referred to as "The Sunshine Act," is legislation designed to provide transparency to the relationship between physicians and industry. Since 2013, medical product and pharmaceutical manufacturers were required to report any payments made to physicians to the Centers for Medicare and Medicaid Services (CMS). We predicted that most clinical faculty at our institution would be found on the Open Payments website. We elected to investigate payments in relationship to divisions within the department of surgery and the level of professorship.All clinical faculty (n = 86) within the department of surgery at our institution were searched within the database: https://openpaymentsdata.cms.gov/. The total amount of payments, number of payments, and the nature of payments (food and beverage, travel and lodging, consulting, education, speaking, entertainment, gifts and honoraria) were recorded for 2017. Comparison by unpaired t-test (or ANOVA) where applicable, significance defined as P 0.05.Of the 86 faculty studied, 75% were found within the CMS Open Payments database in 2017. The mean amount of payment was $4024 (range $13-152,215). Median amount of payment was $434.90 (range $12.75-152,214.70). Faculty receiving outside compensation varied significantly by division and academic rank (P 0.05). Plastic surgery had the highest percentage of people receiving any form of payment ($143-$1912) and GI surgery had the largest payments associated with device management ($0-$152,215). The variation seen by rank was driven by a small number of faculty with receipt of large payments at the associate professor level. The median amount of payment was $428.53 (range $13.97-2306.05) for assistant professors, $5328.03 (range $28.30-152,214.70) for Associate Professors, and $753.82 (range $12.75-17,708.65) for full professors.Reporting of open payments to CMS provides transparency between physicians and industry. The significant relationship of division and rank with open payments database is driven by relatively few faculty. The majority (94%) received either no payments or less than $10,000.

While idiopathic pulmonary fibrosis (IPF) remains the exemplar progressive fibrotic lung disease, there remains a cohort of non-IPF fibrotic lung diseases (fILD) which adopt a similar clinical behaviour to IPF despite therapy [1]. This phenotypically related group of conditions, where progression of disease is similar to that seen in IPF, have recently been described as progressive fibrotic interstitial lung diseases (PF-ILD) [2]. Historically, treatments for these cases have been limited though given the phenotypic similarities many cases may have been given a multidisciplinary working diagnosis of IPF based on their disease behaviour [3]. The INBUILD trial broadened the scope of treatable fILD by demonstrating a significant benefit of Nintedanib in patients with fILD and progressive disease [4]. In response to this the European Commission approved an additional indication for nintedanib in adults for the treatment of PF-ILD in July 2020., Almost 15% of new referrals with non-IPF fibrotic ILD go on to develop a progressive fibrotic phenotype and would benefit from antifibrotic therapy https://bit.ly/3uPhClN

IMPORTANCE: The Epic Sepsis Model (ESM), a proprietary sepsis prediction model, is implemented at hundreds of US hospitals. The ESM’s ability to identify patients with sepsis has not been adequately evaluated despite widespread use. OBJECTIVE: To externally validate the ESM in the prediction of sepsis and evaluate its potential clinical value compared with usual care. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study was conducted among 27 697 patients aged 18 years or older admitted to Michigan Medicine, the academic health system of the University of Michigan, Ann Arbor, with 38 455 hospitalizations between December 6, 2018, and October 20, 2019. EXPOSURE: The ESM score, calculated every 15 minutes. MAIN OUTCOMES AND MEASURES: Sepsis, as defined by a composite of (1) the Centers for Disease Control and Prevention surveillance criteria and (2) International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnostic codes accompanied by 2 systemic inflammatory response syndrome criteria and 1 organ dysfunction criterion within 6 hours of one another. Model discrimination was assessed using the area under the receiver operating characteristic curve at the hospitalization level and with prediction horizons of 4, 8, 12, and 24 hours. Model calibration was evaluated with calibration plots. The potential clinical benefit associated with the ESM was assessed by evaluating the added benefit of the ESM score compared with contemporary clinical practice (based on timely administration of antibiotics). Alert fatigue was evaluated by comparing the clinical value of different alerting strategies. RESULTS: We identified 27 697 patients who had 38 455 hospitalizations (21 904 women [57%]; median age, 56 years [interquartile range, 35-69 years]) meeting inclusion criteria, of whom sepsis occurred in 2552 (7%). The ESM had a hospitalization-level area under the receiver operating characteristic curve of 0.63 (95% CI, 0.62-0.64). The ESM identified 183 of 2552 patients with sepsis (7%) who did not receive timely administration of antibiotics, highlighting the low sensitivity of the ESM in comparison with contemporary clinical practice. The ESM also did not identify 1709 patients with sepsis (67%) despite generating alerts for an ESM score of 6 or higher for 6971 of all 38 455 hospitalized patients (18%), thus creating a large burden of alert fatigue. CONCLUSIONS AND RELEVANCE: This external validation cohort study suggests that the ESM has poor discrimination and calibration in predicting the onset of sepsis. The widespread adoption of the ESM despite its poor performance raises fundamental concerns about sepsis management on a national level.

Purpose To report the representation of female ophthalmologists receiving private industry funding from 2015 through 2018 and compare to previously observed trends. Design Retrospective, comparative trend study Methods Setting: United States of America Study Population: U.S. ophthalmologists listed in CMS Open Payments Database Procedures: Data were reviewed for payments for research, consulting, honoraria, industry grants, faculty and speakers, royalties, and services other than consulting. Main Outcomes and Measures: Primary outcome measure was percentage of female representation compared to male in each sub-category of payment. Results The percentage of female, board-certified ophthalmologists who practiced in the United States ranged from 21.3% and 24.1%. The total number of reported ophthalmologists with industry ties ranged from 1,629 to 1,873 of whom between 17.2% and 19.4% were women. Women received significantly less industry compensation by than men in 2015 (median average $3273 vs $4825, p=.003), 2016 ($3600 vs $4750, p=.023), 2017 ($2493 vs $3500, p=.013), and 2018 ($2000 vs $3000, p=.011). Women remained underrepresented in receiving payments for research (ranging from 5.4% of total paid for research to 8.0%), consulting (11%-17.4%), honoraria (6%-14.9%), industry grants (4%-41.2%), royalties and licenses (0.1%-10.2%), faculty and speakers (11.6%-16.4%), and services other than consulting (8.4%-28.9%). Compared to 2013-2014, an increasing proportion of women received industry payments for consulting (P=.012), honoraria (P=.007), royalties and licenses (P=.019), faculty and speakers (P=.007), and services other than consulting (P=.007). Conclusions Female ophthalmologists remain underrepresented in terms of the percentage of women who receive private industry funding and dollar value of the funding.

Introduction. There are different scoring systems to differentiate risk groups in patients with DLBCL treated with chemoimmunotherapy. Those systems have used the same 5 variables (age, performance status, LDH, stage, extranodal involvement) for 27 years. However, LATAM data have not been included in the development of previous scoring systems. It is important to mention that novel biological variables, such as albumin, beta-2-microglobulin (B2M) and platelet/lymphocyte ratio (PLR), have been reported and could improve discrimination (Villela et al. Blood 2019; 134Suppl_1: 1613). Therefore, we carried out a large, multinational study to develop and validate a LATAM-IPI score. Methods. This is a retrospective cohort of 1030 patients with a diagnosis of DLBCL treated with standard chemoimmunotherapy with curative intent between 2010 and 2018. Data were obtained from 8 LATAM countries: Argentina, Colombia, Chile, Guatemala, Mexico, Paraguay, Peru, and Venezuela. The five classic IPI variables (age, ECOG, extranodal involvement, LDH, stage) were analyzed and albumin and PLR were added (Villela et al. Blood 2019; 134Suppl_1: 1613). B2M was not included because it was not requested regularly in all countries. Development of LATAM-IPI: The training set consisted of 85% of the sample, randomly selected, and the remaining 15% was reserved for internal validation. Using the training set, the univariate and multivariate association between clinical prognostic factors and OS was analyzed fitting Cox proportional-hazard models. Outcomes. Clinical characteristics of the training (n=878) and internal validation (n=151) cohorts are shown in Table 1. There were no statistical differences in baseline characteristics between the cohorts. The median follow-up for the whole cohort was 36 months (IQR: 11-57). When exploring the classic IPI variables on the training set, all variables were associated with high risk of mortality [age 65-74, Hazard Ratio (HR) 1.24, 95% CI 0.96 to 1.58, p=0.08; age ≥75, HR 1.71, 95% CI 1.28 to 2.28, p=0.0003), ECOG (≥ 2, HR=2, 95% CI 1.61 to 2.53; p Conclusions: Using multinational learning and validation cohorts including over 1,000 DLBCL patients treated with standard chemoimmunotherapy in LATAM, we developed a novel LATAM-IPI score using age ≥75 years, ECOG ≥2, advanced stage, LDH ratio (1.1-29 and ≥3) and albumin Disclosures Villela: amgen: Speakers Bureau; Roche: Other: advisory board, Speakers Bureau. Idrobo:Janssen: Honoraria, Speakers Bureau; Amgen: Honoraria, Speakers Bureau; Abbvie: Honoraria, Speakers Bureau; Tecnofarma: Honoraria, Speakers Bureau; Takeda: Honoraria, Speakers Bureau. Gomez-Almaguer:Amgen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene/BMS: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AstraZeneca: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pfizer: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Roche: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Castillo:Janssen: Consultancy, Research Funding; TG Therapeutics: Research Funding; Kymera: Consultancy; Abbvie: Research Funding; Beigene: Consultancy, Research Funding; Pharmacyclics: Consultancy, Research Funding.

Information systems in this day and age is growing very rapidly and sophisticated. However, during this time MDTA has not been touched by technology in terms of teacher data and education reporting system. But now there is a government policy to give honorarium to MDTA teachers must be recorded accurately using the information system. This system is done by waterfall method which is a systematic and sequential system information development model. Data collection methods used were diagnostic, interview (interview), and literature study. In making the system used in making design and design of this information system that is using flowchart. The programming used is programming sites using MySQL database and PHP. This system can facilitate input data of teachers of MDTA, and able to perform tasks accurately and carefully in decision making at Setdakab Labuhanbatu Rantauprapat Office.

This study aims to determine the effectiveness of the management of the transfer of educational personnel under the provincial government along with its obstacles. The results revealed that 463 educators were teaching at 10 public SMA including 2 private SMA in Lhokseumawe city, Aceh, Indonesia. Besides, 325 educators teaching at 13 State Vocational High Schools including 3 private SMK, and 276 non-PNS educators who teach at 10 SMA and 13 SMK. The conclusion is that the management of the transfer of education personnel under the provincial government has not been realized effectively, because there are still various obstacles, including personnel administration processes such as teacher certification, teacher promotion and provision of teacher allowances as well as increasing teacher resources (HR) through an increasingly long bureaucratic process. Apart from that, non-civil servant educators who have had a less than satisfying fate, because there is no clarity and certainty about their future destiny. Efforts made are the socialization of Law Number 23 of 2014 concerning Regional Government and the management of BKN Number 1 of 2016 concerning the transfer of educators to the Provincial Government. Other efforts include improving personnel administration services (teacher certification, promotion and determination of educational personnel allowances for teachers) as well as taking policies to clarify the status and honorarium/salary of non-PNS teachers.

The study is aimed at knowing, understanding and describing in detail the planning and implementation of the school program and the follow-up activity of academic supervision at SMPN 3 Tabelangan Sampang Madura. The approach of the study makes use of a qualitative approach through the case study. The research subjects are school principal, vice-principal, 2 senior teachers, and 10 PNS teachers and honorarium teachers. The data are collected through observation, interviews, and documentation. The result of the study shows that the planning of the school program which is conducted by the school principal, vice-principal, and senior teachers, does not involve all related elements that affect the success of the academic supervision program. The implementation of academic supervision which involves school principal and senior teachers uses the direct method. The follow-up activity of academic supervision is merely giving founding and reinforcement to the teachers. Based on the result of the study, it is found that the implementation of academic supervision conducted by the school principal has not been reached effectively in improving the better teaching result.

This study aims to determine the effect of job expectations (JE), job satisfaction (JS), and government policy (PG) on work stress (WS), work passion (JEn), and continuance commitment (CC) to honorarium teachers in middle and high school. Data collection was done through questionnaires and analyzed using the SEM approach with the help of the Lisrel 8.80 program. The results of the analysis show that the variables JE, JS, and PG have an influence on WS; and WS has an influence on JEn and CC. Explicitly, the conditions and situations faced by honorary teachers tend to create a desire to find new workplaces. This was also reinforced by the issuance of Government Regulation No. 49/2019 concerning the acceptance of workers with work agreements and prohibits the existence of honorarium status. It is recommended, it is necessary to give priority to honorary teachers by not using work contracts, but by treating them for a certain period of time, then being appointed as permanent (non-ASN) teachers if they are judged to meet their requirements and eligibility.

The clinical and cost-effectiveness of collaborative care for improving outcomes in people with mental and physical comorbidities is well established. However, translating these models into enduring change in routine care has proved difficult. In this editorial we outline how to shift the conversation on collaborative care from ‘what are we supposed to do?’ to ‘how we can do this’.Declaration of interestP.P.R. has received honoraria from Publicis LifeBrands and the Institute for Healthcare Improvement outside of the submitted work. H.A.P. reports personal fees from the BIND Health Plan outside of the submitted work; and is a Member of the Council on Quality of Care of the American Psychiatric Association.

Background: In India, tuberculosis remains as a major public health problem amongst the tribal population. Poor physical access to diagnosis and treatment under the Revised National TB control programme (RNTCP) still remains the problem for the population. RNTCP implements Tribal Action Plan (TAP) for tribal patients. We conducted the study to determine the trends of financial utilisation for the special provisions available under tribal action plan like patient honorarium, incentive for sputum collection and transport, incentive for programme staff and incentive for vehicle maintenance. Methods: A cross-sectional study based on mixed method study approach was conducted in Chhattisgarh, India during Nov. 16 to Jun. 17. District TB Officers implementing TAP were interviewed telephonically using a semi-structured questionnaire to ascertain and analyse the reasons for low fund utilization in their districts. Retrospective financial data for five financial years from 13 TAP districts for 2012-2013 to 2016-2017 was collected, compiled and analysed. Results: Overall, the trends on states expenditure on tribal action plan in terms of absolute numbers has increased over the past five years; however, in terms of fund utilization against received ranges from 37% - 86% with the utilization rate less than 44% in the recent years (2014-2017). Conclusion: The trends of utilisation of TAP is less than 44% over the recent years. There is an urgent need for the administrators to intervene and improve the efficiency of fund utilisation at State and district levels.

Professional zakat is zakat issued from income, salary, services, wages or honorarium obtained by lawful means when it has arrived at the Nisab. The issuance of professional zakat is wiser and better if the community issues zakat from the total assets they get after the basic needs are met (net) in this case clothing, shelter, food, and basic necessities are no more than that. One fundamental mistake is to ignore the philosophy of Nisab and the occurrence of the determination of Nisab based on Gross (Gross) and Net (Net) income, which implies the uncertainty of professional zakat in addition to the practice of the syara order.

Background: The ESMO Resilience Task Force has investigated wellbeing since COVID-19 in relation to work, lifestyle and support factors in oncology professionals globally. We reported on the significant impact of the initial surge of the pandemic on wellbeing and job performance (Banerjee et al. 2021). As the pandemic continues, it is imperative to understand experiences and concerns to better inform support measures for the oncology workforce. Methods: Three anonymous online surveys were conducted during the COVID-19 pandemic (S1, Apr/May 2020;S2, Jul/Aug 2020;S3, Feb/Mar 2021). Longitudinal analysis of responses at these timepoints were conducted. Here, we present responses to questions on job demands and resources, and perceived job performance since COVID-19 (JP-CV). Results: We analysed 3894 individual responses (S1, n=1520;S2, n=942;S3, n=1432): 53% (n=1961/3731) female, 45% (n=1679/3731) =/ 100 countries. There has been significant increases from S1 to S3 (p

The Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) project has described phenotypic differences of severe asthma using a systems biology approach. We obtained three molecular phenotypes termed transcription-associated clusters (TACs) using hierarchical clustering of differentially expressed transcripts between T2-high and T2-low [1]. TAC1 was characterised by receptors IL33R, CCR3 and TSLPR, with the highest enrichment of gene signatures for IL-13/type-2 (T2) inflammation with sputum eosinophilia; TAC2 by inflammasome-associated genes, interferon-α (IFN-α) and tumour necrosis factor-α (TNF-α)-associated genes with sputum neutrophilia; and TAC3 by metabolic and mitochondrial function genes with pauci-granulocytic inflammation. Given that sputum eosinophilia may vary with time in many asthmatic subjects [2, 3], we hypothesised that TAC status may also change with time., At 1 year, 45% of severe asthma change molecular phenotype as determined by sputum transcriptomic analysis. Together with concomitant shift in sputum granulocytic markers, this may indicate variability of driving mechanisms in this unstable group. https://bit.ly/35aj489

Proposed short titleY90-Resin Microspheres Radioembolization Followed by Nivolumab in Advanced Hepatocellular CarcinomaBackground : Nivolumab (N) and Y90-resin microspheres radioembolization (Y90-RE) aretherapeutic options in advanced hepatocellular carcinoma (aHCC). Emerging evidence suggests synergy between radiotherapy and immune checkpoint inhibitors. Methods : Eligible Child-Pugh A aHCC patients were treated with Y90-RE followed by N 240mg, 21 days after Y90-RE and every 2 weeks thereafter. Pre- and on-treatment tumor biopsies were obtained. Primary end-point was overall response rate (ORR) (RECIST v1·1), defined as the composite overall response observed for lesions both within and outside Y90-RE field. Secondary end points included progression free survival (PFS), overall survival (OS), and safety. This study is registered with ClinicalTrials.gov, NCT03033446 .Findings : Forty patients were enrolled, 36 received Y90-RE followed by N. At baseline: 61·1% had hepatitis B; 66·7% BCLC stage C; 50·0% had AFP > 400ng/mL; median number of liver lesions was 5 (range 1- >20); median size of largest liver lesion was 78·5 mm (range 14-177mm); 38·9% had prior TACE/RFA/MWA; and 12·5% had prior systemic therapy. ORR was 30·6% (16·4% to 48·1%). ORR was 43·5% in patients with no extra-hepatic spread (EHS) (n=23). 81% of target lesions within Y90-RE field regressed. Median PFS and OS were 5·6 months (95% CI 2·1 to 8·8 months) and 16.9 months (95% CI 8·1 to 27·6 months). Treatment was well tolerated with only 13·8% experiencing grade (G) 3/4 treatment related adverse events (TRAEs). Immune activation predicted response to Y90-RE followed by N. Interpretation : Y90-RE followed by N resulted in an encouraging ORR of 30·6% in aHCC and of 43·5% in subjects with no EHS. 81% of target lesions within Y90-RE field regressed suggesting synergy. Importantly, this combination is safe and tolerable with low G 3/4 TRAEs of 13·8%. Trial Registration: NCT number: NCT03033446 Funding: Funding for this study was acquired from National Medical Research Council Singapore (NMRC/CIRG/1454/2016), Bristol-Myers Squibb (BMS), and SIRTEX Declaration of Interest: David Tai All support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.): BMS, SIRTEX, NMRC Singapore (CIRG/1470/2017) Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: IPSEN, Eisai, BMS Consulting fees: Novartis, BMS, MSD Choo Su Pin Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Roche, BMS, Ipsen, Lilly, AZ, Roche. Consulting fees: BMS, Roche, Ipsen, Servier, Eisai, AstraZeneca. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: MOH Medishield Life Cancer Drug committee Stock or stock options: BMS David Ng All support for the present manuscript (e.g., funding, provision of study materials, medical writing, article processing charges, etc.): SIRTEX Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: SIRTEX Joycelyn Lee Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: BMS, IPSEN, Bayer Research Funding: Bayer Pierce K.H. Chow Grants or contracts from any entity: Sirtex Medical, Ipsen, IQVIA, New B Innovation, Perspectum, AMiLi, MiRXES, Genentech, Engine Biosciences. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Sirtex Medical, Ipsen, Oncosil, Bayer, Roche, New B Innovation, MSD, BTG PLC, Eisai, Abbott, AZ, IQVIA, Genentech, Worrell Guerbet, LEK Consulting, COR2ED. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: AVATAMED Stock or stock options: AVATAMED Too Chow Wei Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: SIRTEX Consulting fees: SIRTEX Ethical Approval: All patients provided written informed consent and the institutional review board committee approved the protocol (Singhealth IRB Ref No. 2016/2613). The study was done in accordance with the Declaration of Helsinki and Good Clinical Practice.

Background: Mobility is defined as the ability to independently move around the environment and is a key contributor to quality of life. The aim of this study was to evaluate the use of mobility as a decisive outcome for the marketing authorisation of drugs by the European Medicines Agency (EMA). Methods: Fifteen therapeutic areas which commonly lead to mobility impairments and alter the quantity and/or the quality of walking were selected: two systemic neurological diseases, four conditions primarily affecting exercise capacity, seven musculoskeletal diseases, and two conditions representing sensory impairments. European Public Assessment Reports (EPARs) published by the EMA up to September 2020 were examined for mobility endpoints included in their ‘main studies’, defined as those which were decisive for EU approval. Clinical study registries and primary scientific publications for these studies were also reviewed. Findings: 484 EPARs yielded 186 relevant documents with 402 ‘main studies’. The EPARs reported 153 primary and 584 secondary endpoints which considered mobility; 70 different assessment tools (38 patient-reported outcomes, 13 clinician-reported outcomes, 8 performance outcomes, and 13 composite endpoints) were used. Importantly, only 15·7% of those tools distinctly informed on patients’ mobility status. 105/402 (26·1%) of the ‘main studies’ did not have any mobility assessment and none of these studies included a digital mobility outcome. The supplementary review of study registries and primary publications revealed only five uses of mobility assessments not reported by EPARs. Interpretation: For conditions with a high impact on mobility, distinct mobility assessment was given little consideration in the marketing authorisation of drugs by the EMA. Where mobility impairment was considered to be a relevant outcome, questionnaires or composite scores were predominantly used. Reporting biases for such outcomes presents challenges for the interpretation of study results. Funding: Mobilise-D (Innovative Medicines Initiative) and Robert Bosch Stiftung, Germany. Declaration of Interest: SJ is partly supported by the Robert Bosch Stiftung Stuttgart. MW reports grants from HORIZON2020 IMI No. 820820, during the conduct of the study. DS reports grants from HORIZON2020 IMI No. 820820, during the conduct of the study. MC reports personal fees from Takeda Pharmaceuticals, during the conduct of the study; personal fees from Takeda Pharmaceuticals, outside the submitted work. JK reports grants from HORIZON2020 IMI No. 820820, during the conduct of the study. JGA reports grants from HORIZON2020 IMI No. 820820, and from AstraZeneca, Chiesi, Esteve, outside the submitted work. WM receives or received funding from the European Union, the German Federal Ministry of Education of Research, Michael J. Fox Foundation, Robert Bosch Foundation, Neuroalliance, Lundbeck and Janssen. He received speaker honoraria from Abbvie, Bayer, GlaxoSmithKline, Licher MT, Rolke Pharma and UCB, was invited to Advisory Boards of Abbvie, Biogen, Lundbeck and Market Access & Pricing Strategy GmbH, and is an advisory board member of the Critical Path for Parkinson's Consortium. He serves as the co-chair of the MDS Technology Task Force. MP reports grants from HORIZON2020 IMI No. 820820, outside the submitted work. MS is supported by the Robert Bosch Stiftung Stuttgart and reports grants from HORIZON2020 IMI 2 Mobilise D, during the conduct of the study, and grants and non-financial support from Green Cross WellBeing Co. Ltd., Gilead Sciences Inc., Robert Bosch GmbH, and CORAT Therapeutics GmbH , as well as other from Agena Bioscience GmbH, outside the submitted work. CB disclosed consultation from E. Lilly and speaker fees from Amgen, Nutricia and Pfizer reports grants from HORIZON2020 IMI No. 820820, during the conduct of the study. RT, BS, LL, LR, SCR declare no competing interests.

Background: We explored parents’ experiences of using a hybrid closed-loop system when caring for a very young child with type 1 diabetes. Our objectives were to understand the impact of using this technology on users’ quality of life and inform its use in routine clinical care. Methods: Interviews were conducted with parents of 30 children (aged 1-7 years) who participated in a randomised controlled trial comparing closed-loop insulin delivery with sensor-augmented pump therapy. Findings: Parents reported major clinical benefits to using the closed-loop system, including more time being spent in range. Parents welcomed opportunities to collaborate with the system (using Ease-off and Boost functions) when their own knowledge could enhance its efficacy. Parents also reported a lessened need for health professional input after the initial transition onto the system had been made. Parents described wide-ranging quality-of-life benefits to using a system that automatically regulated blood glucose. Parents reported sleeping better, worrying less about their child and feeling more confident entrusting their child’s care to others, and how these individuals were more willing to assume caregiving responsibilities. Parents also described how their child felt more normal and experienced better sleep, mood and concentration, and lessened distress. Siblings also benefitted from parents’ time and attention being less focused on diabetes management. While parents highlighted multiple benefits to being able to administer insulin using a smartphone, difficulties were experienced stowing this device on the child’s body. Interpretation: Using a hybrid closed-loop system in very young children can have potentially life-changing consequences and may result in a lessened demand for health professionals’ input. Systems may need to be customised for use in very young children. Funding Information: The European Commission within the Horizon 2020 Framework Programme under the grant agreement number 731560 funded this work. Declaration of Interests: RH reports having received speaker honoraria from Eli Lilly and Novo Nordisk, serving on advisory panels for Eli Lilly and Novo Nordisk, receiving licence fees from BBraun and Medtronic. RH reports patent patents, patent applications, shareholding and directorship at CamDiab. FC has attended Advisory Boards and obtained speaking fees for Abbott, Medtronic, Lilly, and NovoNordisk. EFR reports having received speaker honoraria from Eli Lilly and Novo Nordisk, and serving on advisory boards for Eli Lilly and Sanofi. SH declares having received speakers honoraria from Eli Lilly, Sanofi and Pfizer. TMK has received speaking honoraria from Eli Lilly and MerckSerono, and consulted Sanofi for a transition brochure. BRM has received speaker honoraria from Abbott Diabetes Care, Eli Lilly, Medtronic, Novo Nordisk, Roche Diabetes Care, Sanofi and Menarini, and has been on the advisory boards of Roche Diabetes Care and Abbott Diabetes Care. The Authors JL, DR, RIH, CKB, JF, JMA, AT, US and BK declare that there is no conflict of interest. Ethics Approval Statement: Participants were consented into the interview study when they were consented into the trial. Approval was received from relevant Ethics Committees in participating sites/countries and relevant national regulatory authorities.

Background: It is unclear how multiple sclerosis (MS) affects the severity of Covid-19. Methods: Hospitalization, Intensive Care Unit (ICU) admission and death after Covid-19 diagnosis of 1362 MS patients were compared to the age and sex-matched Italian population in a retrospective observational case-cohort study with population-based control. The observed vs the expected events were compared in the whole MS cohort and in different subgroups (higher-risk: EDSS>3 or at least one comorbidity, lower-risk: EDSS

Background: Coronavirus disease 2019 (COVID-19) associated pulmonary aspergillosis (CAPA) has emerged as a complication in critically ill COVID-19 patients. To determine the prevalence of CAPA in patients with COVID-19 in intensive care units (ICU) and to investigate risk factors for CAPA as well as outcome. Methods: The European Confederation of Medical Mycology (ECMM) conducted a multinational study including 20 centers from nine different countries to assess epidemiology, risk factors, treatment and outcome of CAPA. CAPA was defined according to ECMM/ISHAM consensus definitions. Findings: A total of 592 patients were included in this study, including 11 (1.9%) patients with histologically proven CAPA, 80 (13.5%) patients with probable CAPA, 18 (3%) with possible CAPA and 483 (81.6%) without CAPA. CAPA was diagnosed a median of 8 days (range 0-31) after ICU admission predominantly in older patients [adjusted hazard ratio (aHR) 1.04 per year] with any form of invasive respiratory support (HR 3.4) and receiving tocilizumab (HR 2.45). Median prevalence of CAPA per center was 10.7% (range 1.7% - 26.8%). CAPA was associated with significantly lower 90-day ICU survival rate (29% in patients with CAPA versus 57% in patients without CAPA; Mantel-Byar p

Coronavirus disease 2019 (COVID-19)–associated mucormycosis (CAM) has recently been increasingly reported, particularly among patients with uncontrolled diabetes. Patients with diabetes and hyperglycemia often display an inflammatory state that may be potentiated by the activation of antiviral immunity to SARS-CoV-2, and thus may favor secondary infections. We analyze 80 published and unpublished cases of CAM, with a predominance (42/80) of cases from India. Uncontrolled diabetes mellitus as well as systemic corticosteroid treatment represented major comorbid predisposing factors and rhino-orbital cerebral mucormycosis was the most frequent presentation of disease. Mortality was high at 49%, driven particularly by those with pulmonary or disseminated mucormycosis and those with cerebral involvement. Furthermore, a significant proportion of surviving patients suffered life-changing morbidities (loss of vision in 46% of survivors). Our review indicates that CAM may be a relevant complication of severe COVID-19, particularly in those with uncontrolled diabetes. Funding: Martin Hoenigl received funding from Astellas for two investigator initiated studies (ISR005824 and ISR005838), and was supported by the National Institutes of Health, Grant UL1TR001442. Agostinho Carvalho was supported by the Fundacao para a Ciencia e a Tecnologia (FCT) (UIDB/50026/2020 and UIDP/50026/2020), the Northern Portugal Regional Operational Programme (NORTE 2020), under the Portugal 2020 Partnership Agreement, through the European Regional Development Fund (ERDF) (NORTE-01-0145-FEDER-000039), the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 847507, and the “la Caixa” Foundation (ID 100010434) and FCT under the agreement LCF/PR/HR17/52190003. Declaration of Interest: MH received research funding from Gilead, Pfizer, Astellas, Scynexis and NIH. JPG received speaker and expert advice fees from Pfizer and Gilead. NK has received research grants or honoraria as a speaker or advisor from Astellas, Gilead, MSD, and Pfizer, outside the submitted work. KL received consultancy fees from SMB Laboratoires Brussels, MSD and Gilead, travel support from Pfizer, speaker fees from FUJIFILM WAKO, Pfizer and Gilead, a service fee from Thermo fisher Scientific. OAC is supported by the German Federal Ministry of Research and Education, is funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) under Germany's Excellence Strategy – CECAD, EXC 2030 – 390661388 and has received research grants from, is an advisor to, or received lecture honoraria from Actelion, Allecra Therapeutics, Al-Jazeera Pharmaceuticals, Amplyx, Astellas, Basilea, Biosys, Cidara, Da Volterra, Entasis, F2G, Gilead, Grupo Biotoscana, Immunic, IQVIA, Janssen, Matinas, Medicines Company, MedPace, Melinta Therapeutics, Menarini, Merck/MSD, Mylan, Nabriva, Noxxon, Octapharma, Paratek, Pfizer, PSI, Roche Diagnostics, Scynexis, and Shionogi. PLW performed diagnostic evaluations and received meeting sponsorship from Bruker, Dynamiker, and Launch Diagnostics; Speakers fees, expert advice fees and meeting sponsorship from Gilead; and speaker and expert advice fees 489 from F2G and speaker fees MSD and Pfizer. Is a founding member of the European Aspergillus PCR Initiative. ACh received funding support from educational grant of Pfizer, MSD Pharmaceutical Ltd, and Gilead. All other authors no conflicts. Ethical Approval: MISSING

Funding Information: Andrew Shennan reports payment/honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Manipal India; support for attending meetings and/or travel from Hologic; leadership or fiduciary roles in the HTA Commissioning Board UK and Action on Pre‐eclampsia charity. Natalie Suff reports no conflicts of interest. Jo Leigh Simpson reports royalties from Springer and Elsevier; consulting fees from the Illumina Clinical Expert Panel 2020; payment or honoraria for lectures, presentations, speakers bureaus, or educational events from the 1 and 2 International Congresses on the Future of Women's Health, and a speaker's bureau at ASRM 2019; participation on a data safety monitoring board or advisory board for the FDA DSMB; and leadership or fiduciary roles in IFFS and PGDIS. Bo Jacobbson reports research grants from Swedish Research Council, Norwegian Research Council, March of Dimes, Burroughs Wellcome Fund and the US National Institute of Health; clinical diagnostic trials on NIPT with Ariosa (completed), Natera (ongoing), Vanadis (completed) and Hologic (ongoing) with expendidures reimbused per patient; clinical probiotic studies with product provided by FukoPharma (ongoing, no funding) and BioGaia (ongoing; also provided a research grant for the specific study); collaboration in IMPACT study where Roche, Perkin Elmer and Thermo Fisher provided reagents to PLGF analyses; coordination of scientific conferences and meetings with commercial partners as such as NNFM 2015, ESPBC 2016 and a Nordic educational meeting about NIPT and preeclampsia screening. Bo Jacobbson is also Chair of the FIGO Working Group for Preterm Birth and the European Association of Perinatal Medicine's special interest group of preterm delivery; steering group member of Genomic Medicine Sweden; chairs the Genomic Medicine Sweden complex diseases group; and is Swedish representative in the Nordic Society of Precision Medicine. Ben W. Mol reports an investigator grant from NHMRC; consultancy for ObsEva; and research funding from Guerbet, Ferring, and Merck KGaA. William A. Grobman reports no conflicts of interest. st nd

Background: Prolonged symptoms after SARS-CoV-2 infection are well-documented. However, which factors influence development of long-term symptoms, how symptoms vary across ethnic groups, and whether long-term symptoms correlate with serologic biomarkers remain elusive. Methods: Adult inpatient and outpatient SARS-CoV-2 RT-PCR positive patients were recruited at Stanford from March 2020 to February 2021. Study participants were seen for in-person visits at diagnosis and every 1-3 months for up to one year after diagnosis; they completed symptom surveys and underwent sampling procedures (blood draw and nasal swab) at each visit. Findings: Our cohort (n=617) ranged from asymptomatic to critical COVID-19 infections. 40% of participants reported at least one symptom associated with COVID-19 six months after diagnosis. Median time from diagnosis to first resolution of all symptoms was 44 days, median time from diagnosis to sustained symptom resolution with no recurring symptoms for one month or longer was 214 days. Serum anti-nucleocapsid IgG level in the first week of infection was predictive of time to symptom resolution. A prior diagnosis of lung disease was associated with longer time to symptom resolution. COVID-19 disease severity, ethnicity, sex, cytomegalovirus (CMV) seropositivity, and remdesivir use did not affect time to sustained symptom resolution. More than 90% of participants had SARS-CoV-2-specific antibody>1000 AU/mL nine months after diagnosis. Interpretation: Our findings showed that all disease severities had a similar risk of developing post-COVID-19 syndrome in an ethnically diverse population. Comorbid lung disease and lower levels of initial IgG response to SARS-CoV-2 nucleocapsid antigen were associated with longer symptom duration. Trial Registration: National clinical trial database NCT04664309. Funding: NIH CTSA grant, U54 NIH Grant, R21 NIEHS, Sean N Parker Center for Allergy and Asthma Research at Stanford University, the Sunshine Foundation, the Crown Foundation, and the Parker Foundation. Declaration of Interest: Dr. Boyd received support for the current manuscript from Meso Scale Discovery and NIH; 418 received consulting fees by Regeneron for expert testimony, has stocks or stock options in 419 AbCellera Biologics; Dr. Chinthrajah reports grants from NIAID, CoFAR, Aimmune, DBV 420 Technologies, Astellas, Regeneron, Stanford Maternal and Child Health Research Institute 421 (MCHRI), and FARE. She is an Advisory Board Member at Alladapt Therapeutics, Novartis, 422 Genentech, Sanofi, Allergenis, and Nutricia; Dr. Manisha Desai received support from Chan 423 Zuckerberg Foundation; Dr. Maecker received grants or contracts from NIH, Bill & Melinda 424 Gates Foundation, Ionis Corporation, Amgen Corporation; Consulting fees from Magarray Corp; 425 payment or honoraria from UCLA, UC Davis; leadership or fiduciary role at Cytek SAB; stocks 426 or stock options at BD Biosciences; Dr. Nadeau reports grants from National Institute of Allergy and Infectious Diseases (NIAID), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Environmental Health Sciences (NIEHS), and Food Allergy Research & Education (FARE); Director of World Allergy Organization (WAO) , Advisor at Cour Pharma, Consultant for Excellergy, Red tree ventures, and Phylaxis, Co-founder of Before Brands, Alladapt, Latitude, and IgGenix; and National Scientific Committee member at Immune Tolerance Network (ITN), and National Institutes of Health (NIH) clinical research centers, outside the submitted work; patents include, “Mixed allergen composition and methods for using the same”, “Granulocyte-based methods for detecting and monitoring immune system disorders”, “Methods and Assays for Detecting and Quantifying Pure Subpopulations of White Blood Cells in Immune System Disorders,” and “Methods of isolating allergen-specific antibodies from humans and uses thereof”; Dr. Benjamin Pinsky received grants or contracts for the present manuscript from MesoScale Diagnostics; Dr. Angele Rogers was a Clinical Trials Advisory Board Member for Merck; Dr. Sindher reports support for the present manuscript from the NIH, Regeneron, DBV Technologies, Aimmune, Novartis, CoFAR, FARE, participated on a DSMB for Astra Zeneca, DBV, and received payment or honorarium from FARE; Neera Ahuja, Maja Artandi, Linda Barman, Catherine Blish, Andra Blomkalns, William Collins, MacKenzie Cox, Linda Geng, Xiaolin Jia, Megan Mahoney, Monali Manohar, Ruth O’hara, Rajan Puri, Katharina Roltgen, Laura Vaughan, Samuel Yang, Shu Cao, Iris Chang, Hena Din, Evan Do, Andrea Fernandez, Alexandra Lee, Natasha Purington, Yael Rosenberg-Hasson, Theo Snow, Daniel Solis, Michelle Verghese, and Yingjie Weng have no conflict of interest. Ethical Approval: This study was reviewed and approved by the Stanford Administrative Panel on Human Subjects in Medical Research.

Background: There are limited data on the frequency of myelin oligodendrocyte glycoprotein (MOG)-IgG and aquaporin-4 (AQP4)-IgG among pediatric-onset MS (POMS) patients and healthy controls. Using a prospective cohort of POMS patients and healthy controls, we aimed to determine the frequency of MOG-IgG and AQP4-IgG in both groups, compare clinical characteristics and outcomes in seronegative vs seropositive children, and identify predictors of final diagnosis. Methods: POMS patients and controls were enrolled at 14 US sites through a case-control study on POMS risk factors. Follow-up data were prospectively collected. Serum AQP4-IgG and MOG-IgG were assessed using live cell-based assays. Medical records were re-reviewed in seropositive cases to confirm final diagnosis. Findings: We included 1196 participants, 493 POMS and 703 controls. AQP4-IgG was negative in all participants. MOG-IgG was positive in 30/493 cases (6%) and 0/703 (0%) controls. Twenty-five of 30 MOG-IgG positives (83%) were determined to have MOG-IgG-associated disease (MOGAD) while 5/30 (17%) maintained a diagnosis of MS. The MOG-IgG false-positive rate was 1%. MOGAD cases, compared with MS, were more commonly female (84% vs 64%; p=0.044), presented at younger age (mean 8∙2±4∙2 vs 14∙7±2∙6 years; p