1,203 results on '"National Institute for Health and Care Research"'
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2. THIRST Alert Trial (THIRST)
- Author
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University College London Hospitals (UCLH) NHS Foundation Trust and National Institute for Health and Care Research (NIHR) UCLH Biomedical Research Centre
- Published
- 2023
3. AI Clinician XP2 - A Study of the AI Clinician Running in Real Time in the ICU
- Author
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National Institute for Health and Care Research and NHS-X
- Published
- 2023
4. Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries
- Author
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Global Health Research Unit on Global Surgery, National Institute for Health and Care Research, Adisa, Adewale, Bahrami-Hessari, Michael, Bhangu, Aneel, George, Christina, Ghosh, Dhruv, Glasbey, James, Haque, Parvez, Ingabire, J C Allen, Kamarajah, Sivesh Kathir, Kudrna, Laura, Ledda, Virginia, Li, Elizabeth, Lillywhite, Robert, Mittal, Rohin, Nepogodiev, Dmitri, Ntirenganya, Faustin, Picciochi, Maria, Simões, Joana Filipa Ferreira, Booth, L, Elliot, R, Kennerton, A S, Pettigrove, K L, Pinney, L, Richard, H, Tottman, R, Wheatstone, P, Wolfenden, John W D, Smith, A, Sayed, A Emad, Goswami, Aakansha Giri, Malik, Aamer, Mclean, Aaron Lawson, Hassan, Abbas, Nazimi, Abd Jabar, Aladna, Abdallah, Abdelgawad, Abdalrahman, Saed, Abdel, Abdelmageed, Abdelfatah, Ghannam, Abdelilah, Mahmoud, Abdelrahman, Alvi, Abdul, Ismail, Abdulaziz, Adesunkanmi, Abdulhafiz, Ebrahim, Abdulla, Al-Mallah, Abdullah, Alqallaf, Abdullah, Durrani, Abdullah, Gabr, Abdullah, Kirfi, Abdullahi Musa, Altaf, Abdulmalik, 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Giancarlo, Maggiore, Giandomenico, Cassese, Gianluca, Franceschini, Gianluca, Pellino, Gianluca, Saponaro, Gianmarco, Pattacini, Gianmaria Casoni, Pantuso, Gianni, Iannella, Giannicola, Bonsaana, Gilbert Batieka, Lever, Gillian, Brachini, Gioia, Giraudo, Giorgio, Lisi, Giorgio, Russo, Giorgio Ivan, Aprea, Giovanni, Pascale, Giovanni, Tomasicchio, Giovanni, Sandri, Giovanni Battista Levi, Armatura, Giulia, Turri, Giulia, Zaccaria, Giulia, Barugola, Giuliano, Lantone, Giuliano, Gasparini, Giulio, Iacob, Giulio, Sozzi, Giulio, Zancana, Giuseppa, Mercante, Giuseppe, Bianco, Giuseppe, Brisinda, Giuseppe, Consorti, Giuseppe, Currò, Giuseppe, Giannaccare, Giuseppe, Palomba, Giuseppe, Pascarella, Giuseppe, Rotunno, Giuseppe, Spriano, Giuseppe, Vizzielli, Giuseppe, Cucinella, Giuseppe, Sica, Giuseppe, Campisi, Giuseppina, Baiocchi, Glauco, Guerra, Glen R, Pacheco, Glenda Marina Falcon, Atis, Gokhan, Augustin, Goran, Šantak, Goran, Chauhan, Govind Singh, Branagan, Graham, Harris, Grant, Stewart, Grant D, Padmore, Greg, Kocher, Gregor Jan, Di Franco, Gregorio, De Jesus Labrador Hernandez, Gregorio, Christodoulidis, Gregory, Neal-Smith, Gregory, Yim, Guang, Piozzi, Guglielmo Niccolò, Claret, Guillem, Yanowsky-Reyes, Guillermo, Dhaity, Guipson Dhaity, Cakmak, Guldeniz Karadeniz, Mohamed, Guleed, Kucuk, Gultekin Ozan, Ancans, Guntis, Banipal, Gurpreet Singh, De Bacco Marangon, Gustavo, Laporte, Gustavo, Martinez-Mier, Gustavo, Recinos, Gustavo, V, Gustavo Miguel Machain, Benshetrit, Guy, Vijgen, Guy, Pickett, Gwynedd, Rodriguez, H Alejandro, Shiwani, Haaris, Derilo, Habtamu, Awad, Hadeel, El Assaad, Hadi, Raji, Hadijat Olaide, Hardgrave, Hailey, Karakullukcu, Haluk Kerim, Abdussalam, Hameedat Opeyemi, Mustafa, Hamid, Parwaiz, Hammad, Khan, Hamza, Arbab, Hana, Naga, Hani, Salem, Hani, Ulgur, Hanife Seyda, Perez-Chrzanowska, Hanna, Greenlee, Hannah, Javanmard-Emamghissi, Hannah, Lederhuber, Hans, Osman, Hany, Adamou, Harissou, Majid, Haroon Javaid, Goor, Harry Van, Spiers, Harry V 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T, William, T, Klatte, T, Abbott, T, Watcyn-Jones, T, Mendes, T, Kulis, T, Sečan, T, Campagnaro, T, Frisoni, T, Simoncini, T, Violante, T, Safranovs, T, Risteski, T, Pang, T, Akinyemi, T, Yotsov, T, Laeke, T, Kochiyama, T, Sholadoye, T, Alekberli, T, Ezomike, U, Giustizieri, U, Grossi, U, Köksoy, Ü, Bork, U, Kisser, U, Ronellenfitsch, U, Saeed, U, Bracale, U, Jayarajah, U, Rauf, U, Bumbasirevic, U, Ferrer, U, Ahmed, U, Bello, U, Jogiat, U, Sadia, U, Galandarov, V, Narayanan, V, Calu, V, Bianchi, V, Ciniero, V, Tonini, V, Silvestri, V, Vijay, V, Dewan, V, Lohsiriwat, V, Thuduvage, V, Mousafeiris, V, Dragisic, V, Sasireka, V, Santric, V, Kusuma, V, Kolli, V, Alonso, V, De Simone, V, Picotti, V, Martínez, V, Panduro-Correa, V, Kakotkin, V, Angulo, V, Turrado-Rodriguez, V, Krishnamoorthy, V, Ban, V, Shah, V, Maiola, V, Giordano, V, La Vaccara, V, Lizzi, V, Papagni, V, Schiavone, V, Satchithanantham, V, Garcia-Virto, V, Jimenez, V, Kumar, V, Shelat, V, Bhat, V, Sodhai, V, Graziadei, V, Kutuzov, V, Stoyanov, V, Oktseloglou, V, Flis, V, Elhassan, W, Yang, W, Soon, W, Tashkandi, W, Al-Khyatt, W, Mabood, W, Bijou, W, Wijenayake, W, D, W, Krawczyk, W, Atkins, W, Bolton, W, White, W, Ceelen, W, Vagena, X, Gozal, Y, Baba, Y, Subramani, Y, Jansen, Y, Mittal, Y, Kara, Y, Zwain, Y, Noureldin, Y, Alawneh, Y, Aydin, Y, Lam, Y, Tang, Y, Lim, Y, Dean, Y, Tanas, Y, Su, Y, Fujimoto, Y, Altinel, Y, Frolova, Y, Oshodi, Y, Fadel, Z, Zahid, Z, Elahi, Z, Djama, Z, Zaheen, Z, Jawad, Z, Demetrashvili, Z, Gebremeskel, Z, Gudisa, Z, Alyami, Z, Garoufalia, Z, Li, Z, Zimak, Z, Radin, Z, and Balogh, Z
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general surgery ,acute care surgery ,Settore MED/18 - CHIRURGIA GENERALE ,climate change ,trauma ,Settore MED/40 - Ginecologia E Ostetricia ,environmental impact ,surgery ,Settore MED/31 - Otorinolaringoiatria ,None ,Medicine and Health Sciences ,Surgery ,operating theatre ,environment - Abstract
Background: Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods: This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low-middle-income countries. Results: In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of 'single-use' consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low-middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion: This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high- and low-middle-income countries.
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- 2023
5. Patient and Public Involvement and Engagement (PPIE) A practical plannning guide for BTRU researchers
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National Institute for Health and Care Research Blood Trasplant Research Unit in Precision Cellular Therapeutics and Shaw, Karen
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- 2023
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6. PPIE Planning tool and template
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National Institute for Health and Care Research Blood Trasplant Research Unit in Precision Cellular Therapeutics and Shaw, Karen
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- 2023
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7. Patient and Public Involvement and Engagement Delivery Plan, 2022-2027
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National Institute for Health and Care Research Blood Trasplant Research Unit in Precision Cellular Therapeutics
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This document sets out the Patient and Public Involvement and Engagement (PPIE) Delivery Plan for the National Institute for Health and Care Research (NIHR) Blood and Transplant Research Unit (BTRU) in Precision Cellular Therapeutics.
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- 2023
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8. Patient and Public Involvement and Engagement Strategy, 2022-2027
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National Institute for Health and Care Research Blood and Transplant Research Unit in Precision Cellular Therapeutics
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- 2022
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9. Cardiac Outcomes in Adults With Mitochondrial Diseases
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Konstantinos Savvatis, Christoffer Rasmus Vissing, Lori Klouvi, Anca Florian, Mehjabin Rahman, Anthony Béhin, Abdallah Fayssoil, Marion Masingue, Tanya Stojkovic, Henri Marc Bécane, Nawal Berber, Fanny Mochel, Denis Duboc, Bertrand Fontaine, Bjørg Krett, Caroline Stalens, Julie Lejeune, Robert D.S. Pitceathly, Luis Lopes, Malika Saadi, Thomas Gossios, Vincent Procaccio, Marco Spinazzi, Céline Tard, Pascal De Groote, Claire-Marie Dhaenens, Claire Douillard, Andoni Echaniz-Laguna, Ros Quinlivan, Michael G. Hanna, Ali Yilmaz, John Vissing, Pascal Laforêt, Perry Elliott, Karim Wahbi, Queen Mary University of London (QMUL), IT University of Copenhagen (ITU), Association française contre les myopathies (AFM-Téléthon), University Hospital Münster - Universitaetsklinikum Muenster [Germany] (UKM), University College of London [London] (UCL), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Raymond Poincaré [Garches], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Université Paris Cité (UPCité), Sorbonne Université (SU), Hôpital Cochin [AP-HP], Aristotle University of Thessaloniki, MitoVasc - Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Département de Biochimie et Génétique [Angers], Université d'Angers (UA)-Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Lille Neurosciences & Cognition - U 1172 (LilNCog), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP), Hôpital Claude Huriez [Lille], CHU Lille, AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Handicap neuromusculaire : Physiopathologie, Biothérapie et Pharmacologies appliquées (END-ICAP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), MR/S005021/1, Association Française contre les Myopathies, AFM, Medical Research Council, MRC: MR/S002065/1, Department of Health and Social Care, DH, University College London Hospitals NHS Foundation Trust, UCLH, NIHR Cambridge Biomedical Research Centre, This study was funded by grants from the Association Française contre les Myopathies (French Alliance against Myopathies), which was not involved in the design and conduct of the study, the collection, management, analysis, and interpretation of the data, the preparation, review or approval of the manuscript, and nor in the decision to submit the manuscript for publication. Dr Pitceathly is supported by a Medical Research Council (United Kingdom) Clinician Scientist Fellowship (MR/S002065/1). Drs Pitceathly and Hanna receive funding from a Medical Research Council (United Kingdom) strategic award to establish an International Centre for Genomic Medicine in Neuromuscular Diseases (ICGNMD) (MR/S005021/1). Dr Lopes is supported by a Medical Research Council (United Kingdom) clinical academic partnership (CARP) award. Dr Quinlivan was funded by National Institute for Health and Care Research Biomedical Research Centre, University College Hospitals Foundation Trust. The University College London Hospitals/University College London Queen Square Institute of Neurology sequencing facility receives a proportion of funding from the Department of Health's National Institute for Health and Care Research Biomedical Research Centre’s funding scheme. The clinical and diagnostic 'Rare Mitochondrial Disorders' Service in London is funded by the U.K. NHS Highly Specialised Commissioners. Dr Elliott has received consultancy fees from Pfizer, Sanofi, Sarepta, DinaQor, Freeline, Novo Nordisk, and Bristol Myers Squibb. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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Adult ,conduction disease ,mitochondrial diseases ,[SDV]Life Sciences [q-bio] ,heart failure ,sudden death ,Heart ,Stroke Volume ,Prognosis ,DNA, Mitochondrial ,Ventricular Function, Left ,single large-scale deletions ,Risk Factors ,Humans ,Hypertrophy, Left Ventricular ,Cardiology and Cardiovascular Medicine ,G%22">m3243A>G - Abstract
International audience; Background: Patients with mitochondrial diseases are at risk of heart failure (HF) and arrhythmic major adverse cardiac events (MACE). Objectives: We developed prediction models to estimate the risk of HF and arrhythmic MACE in this population. Methods: We determined the incidence and searched for predictors of HF and arrhythmic MACE using Cox regression in 600 adult patients from a multicenter registry with genetically confirmed mitochondrial diseases. Results: Over a median follow-up time of 6.67 years, 29 patients (4.9%) reached the HF endpoint, including 19 hospitalizations for nonterminal HF, 2 cardiac transplantations, and 8 deaths from HF. Thirty others (5.1%) reached the arrhythmic MACE, including 21 with third-degree or type II second-degree atrioventricular blocks, 4 with sinus node dysfunction, and 5 sudden cardiac deaths. Predictors of HF were the m.3243A>G variant (HR: 4.3; 95% CI: 1.8-10.1), conduction defects (HR: 3.0; 95% CI: 1.3-6.9), left ventricular (LV) hypertrophy (HR: 2.6; 95% CI: 1.1-5.8), LV ejection fraction
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- 2022
10. Current pressure on the UK imaging workforce deters imaging research in the NHS and requires urgent attention.
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Rodrigues, J.C.L., O'Regan, T., Darekar, A., Taylor, S., Goh, V., and National Institute for Health and Care Research (NIHR) Imaging Workforce Group, NIHR Imaging Steering Group, and NIHR Clinical Research Network Imaging Champions
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LABOR supply , *CLINICAL governance , *MEDICAL physics , *MEDICAL research , *RESEARCH institutes , *MEDICAL digital radiography , *NATIONAL health services , *DIAGNOSTIC imaging , *MEDICAL specialties & specialists - Abstract
Medical imaging is a multidisciplinary specialty, combining clinical expertise from medical physics, radiography, and radiology, and plays a key role in patient care. Research is vital to ensure the care delivered to patients is evidence-based, and is a core component of clinical governance; however, there are pressures on the imaging workforce, which are significantly impeding imaging research. This commentary presents a research gap analysis pertaining to the multidisciplinary imaging workforce on behalf of the National Institute for Health Research (NIHR) Imaging Workforce Group. Data were summarised from membership surveys of the Royal College of Radiologists, Society and College of Radiographers, and Institute of Physics and Engineering in Medicine; national reports; and feedback from NIHR Clinical Research Network Imaging Champions meeting in 2020/2021. Common barriers to delivering research were found across the multidisciplinary workforce. The key issues were lack of staff, lack of time, and lack of funding to backfill clinical services. Given the ongoing workforce shortages and increasing clinical demands on radiologists, diagnostic radiographers, and medical physicists, these issues must be tackled with a high priority to ensure the future of clinical research within the NHS. [ABSTRACT FROM AUTHOR]
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- 2022
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11. Effect of Antiplatelet Therapy on Survival and Organ Support-Free Days in Critically Ill Patients With COVID-19
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Bradbury, Charlotte A., Lawler, Patrick R., Stanworth, Simon J., McVerry, Bryan J., McQuilten, Zoe, Higgins, Alisa M., Mouncey, Paul R., Al-Beidh, Farah, Rowan, Kathryn M., Berry, Lindsay R., Lorenzi, Elizabeth, Zarychanski, Ryan, Arabi, Yaseen M., Annane, Djillali, Beane, Abi, Van Bentum-Puijk, Wilma, Bhimani, Zahra, Bihari, Shailesh, Bonten, Marc J. M., Brunkhorst, Frank M., Buzgau, Adrian, Buxton, Meredith, Carrier, Marc, Cheng, Allen C., Cove, Matthew, Detry, Michelle A., Estcourt, Lise J., Fitzgerald, Mark, Girard, Timothy D., Goligher, Ewan C., Goossens, Herman, Haniffa, Rashan, Hills, Thomas, Huang, David T., Horvat, Christopher M., Hunt, Beverley J., Ichihara, Nao, Lamontagne, Francois, Leavis, Helen L., Linstrum, Kelsey M., Litton, Edward, Marshall, John C., McAuley, Daniel F., McGlothlin, Anna, McGuinness, Shay P., Middeldorp, Saskia, Montgomery, Stephanie K., Morpeth, Susan C., Murthy, Srinivas, Neal, Matthew D., Nichol, Alistair D., Parke, Rachael L., Parker, Jane C., Reyes, Luis, Saito, Hiroki, Santos, Marlene S., Saunders, Christina T., Serpa-Neto, Ary, Seymour, Christopher W., Shankar-Hari, Manu, Singh, Vanessa, Tolppa, Timo, Turgeon, Alexis F., Turner, Anne M., van de Veerdonk, Frank L., Green, Cameron, Lewis, Roger J., Angus, Derek C., McArthur, Colin J., Berry, Scott, Derde, Lennie P. G., Webb, Steve A., Gordon, Anthony C., Depuydt, Pieter, De Waele, Jan, De Bus, Liesbet, Fierens, Jan, Vermassen, Joris, REMAP-CAP Investigators, University of Bristol [Bristol], University Health Network, University of Toronto, University of Oxford, University of Pittsburgh (PITT), Pennsylvania Commonwealth System of Higher Education (PCSHE), Monash University [Melbourne], Imperial College London, University of Manitoba [Winnipeg], Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), University Medical Center [Utrecht], St. Michael's Hospital, 215522, CS-2016-16-011, RP-2015-06-18, National Institutes of Health, NIH, U.S. Department of Defense, DOD, National Institute of General Medical Sciences, NIGMS, National Institute of Neurological Disorders and Stroke, NINDS, Gordon and Betty Moore Foundation, GBMF, Medtronic, Baxter International, Medical Center, University of Pittsburgh, CancerCare Manitoba Foundation, CCMF, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NICHD, Wellcome Trust, WT, Health Research Board, HRB: CTN 2014-012, Horizon 2020 Framework Programme, H2020: 101003589, LAM Therapeutics, Canadian Institutes of Health Research, IRSC: 158584, Medical Research Council, MRC, National Institute for Health and Care Research, NIHR, European Commission, EC, National Heart and Lung Institute, NHLI, Queen's University Belfast, QUB: US8962032, National Health and Medical Research Council, NHMRC: APP1101719, National Medical Research Council, NMRC, Health Research Council of New Zealand, HRC: 16/631, Ministère des Affaires Sociales et de la Santé: PHRC-20-0147, Innovate UK, Horizon 2020, Pharmaceuticals Bayer, Swedish Orphan Biovitrum, NIHR Imperial Biomedical Research Centre, BRC, Minderoo Foundation, Funding/Support: This study was funded by the following: the Platform for European Preparedness Against (Re-)Emerging Epidemics (PREPARE) consortium of the European Union, FP7-HEALTH-2013-INNOVATION-1 (grant 602525), the Rapid European COVID-19 Emergency Research Response (RECOVER) consortium of the European Union’s Horizon 2020 Research and Innovation Programme (grant 101003589), the Australian National Health and Medical Research Council (grant APP1101719), the Health Research Council of New Zealand (grant 16/631), the Canadian Institute of Health Research Strategy for Patient-Oriented Research Innovative Clinical Trials Program (grant 158584), the NIHR and the NIHR Imperial Biomedical Research Centre, the Health Research Board of Ireland (grant CTN 2014-012), the University of Pittsburgh Medical Center (UPMC) Learning While Doing Program, the Translational Breast Cancer Research Consortium, the French Ministry of Health (grant PHRC-20-0147), the Minderoo Foundation, and the Wellcome Trust Innovations Project (grant 215522). Dr Shankar-Hari is funded by an NIHR clinician scientist fellowship (grant CS-2016-16-011) and Dr Gordon is funded by an NIHR research professorship (grant RP-2015-06-18)., The REMAP-CAP platform is supported by the Australian and New Zealand Intensive Care Society Clinical Trials Group, the Canadian Critical Care Clinical Trials Group, the Irish Critical Care Clinical Trials Network, the UK Critical Care Research Group and the International Forum of Acute Care Trialists., REMAP-CAP was supported in the Netherlands by the Research Collaboration Critical Care the Netherlands, reported receipt of personal fees from Lilly, BMS-Pfizer, Bayer, Amgen, Novartis, Janssen, Portola, Ablynx, and Grifols. Dr Lawler reported receipt of personal fees from Novartis, CorEvitas, and Brigham and Women’s Hospital and royalties from McGraw-Hill Publishing. Dr McVerry reported receipt of grants from the National Heart, Lung, and Blood Institute and Bayer Pharmaceuticals and personal fees from Boehringer Ingelheim. Dr L. Berry reported being an employee of Berry Consultants, Berry Consultants receives payments for the statistical analysis and design of REMAP-CAP. Dr Lorenzi reported being an employee of Berry Consultants, Berry Consultants receives payments for the statistical analysis and design of REMAP-CAP. Dr Zarychanski reported receipt of grants from the Canadian Institutes of Health Research, LifeArc, Research Manitoba, the CancerCare Manitoba Foundation, Peter Munk Cardiac Centre, and the Thistledown Foundation and research operating support as the Lyonel G. Israels Research Chair in Hematology. Dr Bonten reported membership in international study steering committees, advisory boards, and independent data safety and monitoring committees funded by Janssen Vaccines, Merck Sharp & Dohme, AstraZeneca, Pfizer, and Sanofi Pasteur (all reimbursements to UMC Utrecht). Dr Brunkhorst reported receipt of grants from Jena University Hospital. Dr Buxton reported receipt of a gift from the Breast Cancer Research Foundation and contracts with Amgen and Eisai. Dr Carrier reported receipt of grants from BMS-Pfizer and personal fees from Bayer, Sanofi, Servier, Leo Phama, and BMS-Pfizer to his institution. Dr Cove reported receipt of grants from the National Medical Research Council and personal fees from Baxter and Medtronic. Dr Estcourt reported receipt of grants from the UK National Institute for Health Research (NIHR) and the European Union Horizon 2020 Research and Innovation Programme. Dr Haniffa reported receipt of grants from the UK Research and Innovation/Medical Research Council African Critical Care Registry Network. Dr Horvat reported receipt of grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Neurological Disorders and Stroke. Dr Ichihara reported being affiliated with the Department of Healthcare Quality Assessment, University of Tokyo, which is a social collaboration supported by the National Clinical Database, Johnson & Johnson, and Nipro Corporation. Dr Marshall reported receipt of personal fees from AM Pharma and Critical Care Medicine. Dr McAuley reported receipt of personal fees from Bayer, GlaxoSmithKline, Boehringer Ingelheim, Novartis, Lilly, Vir Biotechnology, Faron Pharmaceutical, and SOBI and grants from the NIHR, the Wellcome Trust, Innovate UK, the UK Medical Research Council, and the Northern Ireland Health and Social Care Research and Development Division, in addition, Dr McAuley had a Queen’s University Belfast patent for novel treatment for inflammatory disease (US8962032), was co-director of research at the Intensive Care Society until June 2021, and was director of the Efficacy and Mechanisms Evaluation Program for the UK Medical Research Council/NIHR. Dr Middeldorp reported receipt of personal fees from Daiichi Sankyo, Bayer, Pfizer, Boehringer Ingelheim, Portola/Alexion, AbbVie, BMS-Pfizer, Sanofi, and Viatris, all paid to his institution, and grants from Daiichi Sankyo, Bayer, Pfizer, and Boehringer Ingelheim. Dr Neal reported equity in Haima Therapeutics, receipt of personal fees from Janssen Pharma and Haemonetics, and receipt of grants from Instrumentation Laboratory, the National Institutes of Health, and the Department of Defense. Dr Nichol reported receipt of personal fees from AM Pharma, paid to his university, and grants from Baxter. Dr Parke reported receipt of grants from Fisher and Paykel Healthcare NZ. Dr Serpa-Neto reported receipt of personal fees from Drager and Endpoint Health. Dr Seymour reported receipt of grants from the Gordon and Betty Moore Foundation and the National Institutes of Health/National Institute of General Medical Sciences. Dr Lewis reported being senior medical scientist at Berry Consultants, Berry Consultants receives payments for the statistical analysis and design of REMAP-CAP. Dr S. Berry reported being an employee with an ownership role at Berry Consultants, Berry Consultants receives payments for the statistical analysis and design of REMAP-CAP. Dr Derde reported being a coordinating committee member for the European Clinical Research Alliance on Infectious Diseases, a member of the Dutch Intensivists Task Force on Acute Infectious Threats, a member of the International Scientific Advisory Board for Sepsis Canada, and a member of the Dutch Academy of Sciences’ Pandemic Preparedness Plan committee. Dr Gordon reported receipt of personal fees from 30 Respiratory, paid to his institution. No other disclosures were reported., European Project: 101003589, H2020-SC1-PHE-CORONAVIRUS-2020,RECOVER(2020), European Project: 602525,EC:FP7:HEALTH,FP7-HEALTH-2013-INNOVATION-1,PREPARE(2014), Investigators, REMAP-CAP Writing Committee for the REMAP-CAP, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, ARD - Amsterdam Reproduction and Development, and Intensive Care Medicine
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Adult ,Male ,Platelet Aggregation Inhibitors/adverse effects ,Critical Illness ,[SDV]Life Sciences [q-bio] ,Vascular damage Radboud Institute for Health Sciences [Radboudumc 16] ,lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4] ,Hemorrhage ,Aspirin/adverse effects ,Hemorrhage/chemically induced ,INFECTION ,Humans ,COAGULOPATHY ,Aspirin ,Anticoagulants ,COVID-19 ,Bayes Theorem ,Venous Thromboembolism ,General Medicine ,Middle Aged ,Respiration, Artificial ,COVID-19 Drug Treatment ,Critical Illness/mortality ,lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] ,Purinergic P2Y Receptor Antagonists/adverse effects ,Purinergic P2Y Receptor Antagonists ,COVID-19/complications ,Female ,Human medicine ,Anticoagulants/adverse effects ,Platelet Aggregation Inhibitors ,Venous Thromboembolism/drug therapy - Abstract
Contains fulltext : 248713.pdf (Publisher’s version ) (Closed access) IMPORTANCE: The efficacy of antiplatelet therapy in critically ill patients with COVID-19 is uncertain. OBJECTIVE: To determine whether antiplatelet therapy improves outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: In an ongoing adaptive platform trial (REMAP-CAP) testing multiple interventions within multiple therapeutic domains, 1557 critically ill adult patients with COVID-19 were enrolled between October 30, 2020, and June 23, 2021, from 105 sites in 8 countries and followed up for 90 days (final follow-up date: July 26, 2021). INTERVENTIONS: Patients were randomized to receive either open-label aspirin (n = 565), a P2Y12 inhibitor (n = 455), or no antiplatelet therapy (control; n = 529). Interventions were continued in the hospital for a maximum of 14 days and were in addition to anticoagulation thromboprophylaxis. MAIN OUTCOMES AND MEASURES: The primary end point was organ support-free days (days alive and free of intensive care unit-based respiratory or cardiovascular organ support) within 21 days, ranging from -1 for any death in hospital (censored at 90 days) to 22 for survivors with no organ support. There were 13 secondary outcomes, including survival to discharge and major bleeding to 14 days. The primary analysis was a bayesian cumulative logistic model. An odds ratio (OR) greater than 1 represented improved survival, more organ support-free days, or both. Efficacy was defined as greater than 99% posterior probability of an OR greater than 1. Futility was defined as greater than 95% posterior probability of an OR less than 1.2 vs control. Intervention equivalence was defined as greater than 90% probability that the OR (compared with each other) was between 1/1.2 and 1.2 for 2 noncontrol interventions. RESULTS: The aspirin and P2Y12 inhibitor groups met the predefined criteria for equivalence at an adaptive analysis and were statistically pooled for further analysis. Enrollment was discontinued after the prespecified criterion for futility was met for the pooled antiplatelet group compared with control. Among the 1557 critically ill patients randomized, 8 patients withdrew consent and 1549 completed the trial (median age, 57 years; 521 [33.6%] female). The median for organ support-free days was 7 (IQR, -1 to 16) in both the antiplatelet and control groups (median-adjusted OR, 1.02 [95% credible interval {CrI}, 0.86-1.23]; 95.7% posterior probability of futility). The proportions of patients surviving to hospital discharge were 71.5% (723/1011) and 67.9% (354/521) in the antiplatelet and control groups, respectively (median-adjusted OR, 1.27 [95% CrI, 0.99-1.62]; adjusted absolute difference, 5% [95% CrI, -0.2% to 9.5%]; 97% posterior probability of efficacy). Among survivors, the median for organ support-free days was 14 in both groups. Major bleeding occurred in 2.1% and 0.4% of patients in the antiplatelet and control groups (adjusted OR, 2.97 [95% CrI, 1.23-8.28]; adjusted absolute risk increase, 0.8% [95% CrI, 0.1%-2.7%]; 99.4% probability of harm). CONCLUSIONS AND RELEVANCE: Among critically ill patients with COVID-19, treatment with an antiplatelet agent, compared with no antiplatelet agent, had a low likelihood of providing improvement in the number of organ support-free days within 21 days. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02735707.
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- 2022
12. Long-term (180-day) outcomes in critically ill patients with COVID-19 in the REMAP-CAP randomized clinical trial
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Florescu, S, Stanciu, D, Zaharia, M, Kosa, A, Codreanu, D, Kidwai, A, Masood, S, Kaye, C, Coutts, A, MacKay, L, Summers, C, Polgarova, P, Farahi, N, Fox, E, McWilliam, S, Hawcutt, D, Rad, L, O’Malley, L, Whitbread, J, Jones, D, Dore, R, Saunderson, P, Kelsall, O, Cowley, N, Wild, L, Thrush, J, Wood, H, Austin, K, Bélteczki, J, Magyar, I, Fazekas, Á, Kovács, S, Szőke, V, Donnelly, A, Kelly, M, Smyth, N, O’Kane, S, McClintock, D, Warnock, M, Campbell, R, McCallion, E, Azaiz, A, Charron, C, Godement, M, Geri, G, Vieillard-Baron, A, Johnson, P, McKenna, S, Hanley, J, Currie, A, Allen, B, McGoldrick, C, McMaster, M, Mani, A, Mathew, M, Kandeepan, R, Vignesh, C, TV, B, Ramakrishnan, N, James, A, Elvira, E, Jayakumar, D, Pratheema, R, Babu, S, Ebenezer, R, Krishnaoorthy, S, Ranganathan, L, Ganesan, M, Shree, M, Guilder, E, Butler, M, Cowdrey, K-A, Robertson, M, Ali, F, McMahon, E, Duffy, E, Chen, Y, Simmonds, C, McConnochie, R, O’Connor, C, El-Khawas, K, Richardson, A, Hill, D, Commons, R, Abdelkharim, H, Saxena, M, Muteithia, M, Dobell-Brown, K, Jha, R, Kalogirou, M, Ellis, C, Krishnamurthy, V, O’Connor, A, Thurairatnam, S, Mukherjee, D, Kaliappan, A, Vertue, M, Nicholson, A, Riches, J, Maloney, G, Kittridge, L, Solesbury, A, Ramos, A, Collins, D, Brickell, K, Reid, L, Smyth, M, Breen, P, Spain, S, Curley, G, McEvoy, N, Geoghegan, P, Clarke, J, Silversides, J, McGuigan, P, Ward, K, O’Neill, A, Finn, S, Wright, C, Green, J, Collins, É, Knott, C, Smith, J, Boschert, C, Slieker, K, Ewalds, E, Sanders, A, Wittenberg, W, Geurts, H, Poojara, L, Sara, T, Nand, K, Reeve, B, Dechert, W, Phillips, B, Oritz-Ruiz de Gordoa, L, Affleck, J, Shaikh, A, Murray, A, Ramanan, M, Frakking, T, Pinnell, J, Robinson, M, Gledhill, L, Wood, T, Sanghavi, R, Bhonagiri, D, Ford, M, Parikh, HG, Avard, B, Nourse, M, McDonald, B, Edmunds, N, Hoiting, O, Peters, M, Rengers, E, Evers, M, Prinssen, A, Morgan, M, Cole, J, Hill, H, Davies, M, Williams, A, Thomas, E, Davies, R, Wise, M, Grimm, P, Soukup, J, Wetzold, R, Löbel, M, Starke, L, Lellouche, F, Lizotte, P, Declerq, P, Antoine, M, Stephanie, G, Jean-Pierre, E, François, B, Marion, B, Philippe, R, Pourcine, F, Monchi, M, Luis, D, Mercier, R, Sagnier, A, Verrier, N, Caplin, C, Richecoeu, J, Combaux, D, Siami, S, Aparicio, C, Vautier, S, Jeblaoui, A, Lemaire-Brunel, D, D'Aragon, F, Carbonneau, E, Leblond, J, Plantefeve, G, Leparco, C, Contou, D, Fartoukh, M, Courtin, L, Labbe, V, Voiriot, G, Salhi, S, Chassé, M, Carrier, F, Boumahni, D, Benettaib, F, Ghamraoui, A, Sement, A, Gachet, A, Hanisch, A, Haffiane, A, Boivin, A-H, Barreau, A, Guerineau, E, Poupblanc, S, Egreteau, P, Lefevre, M, Bocher, S, Le Loup, G, Le Guen, L, Carn, V, Bertel, M, Antcliffe, D, Templeton, M, Rojo, R, Coghlan, P, Smee, J, Barker, G, Finn, A, Kreb, G, Hoff, U, Hinrichs, C, Nee, J, Mackay, E, Cort, J, Whileman, A, Spencer, T, Spittle, N, Beavis, S, Padmakumar, A, Dale, K, Hawes, J, Moakes, E, Gascoyne, R, Pritchard, K, Stevenson, L, Cooke, J, 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Bowen, D, Kong, J, Joy, J, Fuchs, R, Lambert, B, Tai, C, Thomas, A, Keen, A, Tierney, C, Omer, N, Bacon, G, Tridente, A, Shuker, K, Anders, J, Greer, S, Scott, P, Millington, A, Buchanan, P, Binnie, A, Powell, E, McMillan, A, Luk, T, Aref, N, Denmade, C, Sadera, G, Jacob, R, Hughes, D, Sterba, M, Geng, W, Digby, S, Southern, D, Reddy, H, Hulse, S, Campbell, A, Garton, M, Watkins, C, Smuts, S, Quinn, A, Simpson, B, McMillan, C, Finch, C, Hill, C, Cooper, J, Budd, J, Small, C, O’Leary, R, Collins, E, Holland, A, Alexander, P, Felton, T, Ferguson, S, Sellers, K, Ward, L, Yates, D, Birkinshaw, I, Kell, K, Scott, Z, Pearson, H, Hashmi, M, Hassan, N, Panjwani, A, Umrani, Z, Shaikh, M, Ain, Q, Kanwal, D, Van Bree, S, Bouw-Ruiter, M, Osinga, M, Van Zanten, A, McEldrew, R, Rashan, S, Singh, V, Azergui, N, Bari, S, Beltran, M, Brugman, C, Groeneveld, E, Jafarzadeh, M, Keijzer-Timmers, N, Kester, E, Koelink, M, Kwakkenbos-Craanen, M, Okundaye, C, Parker, L, Peters, S, Post, S, Rietveld, I, Scheepstra-Beukers, I, Schreuder, G, Smit, A, Brillinger, N, Markgraf, R, Eichinger, F, Doran, P, Anjum, A, Best-Lane, J, Barton, F, Miller, L, Richards-Belle, A, Saull, M, Sprinckmoller, S, Wiley, D, Darnell, R, Au, C, Lindstrum, K, Cheng, A, Forbes, A, Heritier, S, Trapani, T, Cuthbertson, B, Manoharan, V, Dondrop, A, Tolppa, T, Ehrmann, S, Hullegie, S, Povoa, P, Beasley, R, Daneman, N, McGloughlin, S, Paterson, D, Venkatesh, B, De Jong, M, Uyeki, T, Baillie, K, Netea, M, Orr, K, Patanwala, A, Tong, S, Cooper, N, Galea, J, Leavis, H, Ogungbenro, K, Patawala, A, Rademaker, E, Youngstein, T, Carrier, M, Fergusson, D, Hunt, B, Kumar, A, Laffan, M, Lother, S, Middeldorp, S, Stanworth, S, De Man, A, Masse, M-H, Abraham, J, Arnold, D, Begin, P, Charlewood, R, Chasse, M, Coyne, M, Daly, J, Gosbell, I, Harvala-Simmonds, H, MacLennan, S, McDyer, J, Menon, D, Pridee, N, Roberts, D, Thomas, H, Tinmouth, A, Triulzi, D, Walsh, T, Wood, E, Calfee, C, O’Kane, C, Shyamsundar, M, Sinha, P, Thompson, T, Young, I, Burrell, A, Ferguson, N, Hodgson, C, Orford, N, Phua, J, Baron, R, Epelman, S, Frankfurter, C, Gommans, F, Kim, E, Leaf, D, Vaduganathan, M, Van Kimmenade, R, Sanil, A, Van Beurden, M, Effelaar, E, Schotsman, J, Boyd, C, Harland, C, Shearer, A, Wren, J, Attanayaka, U, Darshana, S, Ishani, P, Udayanga, I, Higgins, AM, Berry, LR, Lorenzi, E, Murthy, S, McQuilten, Z, Mouncey, PR, Al-Beidh, F, Annane, D, Arabi, YM, Beane, A, Van Bentum-Puijk, W, Bhimani, Z, Bonten, MJM, Bradbury, CA, Brunkhorst, FM, Buzgau, A, Buxton, M, Charles, WN, Cove, M, Detry, MA, Estcourt, LJ, Fagbodun, EO, Fitzgerald, M, Girard, TD, Goligher, EC, Goossens, H, Haniffa, R, Hills, T, Horvat, CM, Huang, DT, Ichihara, N, Lamontagne, F, Marshall, JC, McAuley, DF, McGlothlin, A, McGuinness, SP, McVerry, BJ, Neal, MD, Nichol, AD, Parke, RL, Parker, JC, Parry-Billings, K, Peters, SEC, Reyes, LF, Rowan, KM, Saito, H, Santos, MS, Saunders, CT, Serpa-Neto, A, Seymour, CW, Shankar-Hari, M, Stronach, LM, Turgeon, AF, Turner, AM, Van de Veerdonk, FL, Zarychanski, R, Green, C, Lewis, RJ, Angus, DC, McArthur, CJ, Berry, S, Derde, LPG, Gordon, AC, Webb, SA, Lawler, PR, Comm REMAP-CAP Investigators, Apollo - University of Cambridge Repository, Intensive Care Medicine, Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Hôpital Raymond Poincaré [Garches], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Pittsburgh Foundation, PF, Amgen, Health Research Board, HRB: CTN 2014-012, Horizon 2020 Framework Programme, H2020: 101003589, Translational Breast Cancer Research Consortium, TBCRC, Canadian Institutes of Health Research, IRSC: 158584, Heart and Stroke Foundation of Canada, HSF, National Institute for Health and Care Research, NIHR, European Commission, EC, National Health and Medical Research Council, NHMRC: 1101719, APP194811, CS-2016-16-011, GNT2008447, RP-2015-06-18, Office of Health and Medical Research, OHMR, Health Research Council of New Zealand, HRC: 16/631, Eisai, Ministère des Affaires Sociales et de la Santé: PHRC-20-0147, Université Pierre et Marie Curie, UPMC, NIHR Imperial Biomedical Research Centre, BRC, Minderoo Foundation, Funding/Support : The Platform for European Preparedness Against (Re-) emerging Epidemics (PREPARE) consortium by the European Union, FP7-HEALTH-2013-INNOVATION-1 (#602525), the Rapid European COVID-19 Emergency Research response (RECOVER) consortium by the European Union’s Horizon 2020 research and innovation programme (#101003589), the Australian National Health and Medical Research Council (#APP1101719), the Australian Medical Research Future Fund (#APP2002132), the Health Research Council of New Zealand (#16/631), the Canadian Institutes of Health Research Strategy for Patient-Oriented Research Innovative Clinical Trials Program Grant (#158584) and the Canadian Institute of Health Research COVID-19 Rapid Research Funding (#447335), the UK National Institute for Health Research (NIHR) and the NIHR Imperial Biomedical Research Centre, the Health Research Board of Ireland (CTN 2014-012), the UPMC Learning While Doing Program, the Translational Breast Cancer Research Consortium, the French Ministry of Health (PHRC-20-0147), the Wellcome Trust Innovations Project (215522), the Minderoo Foundation, the EU Programme Emergency Support Instrument, the NHS Blood and Transplant Research and Development Programme, the Translational Breast Cancer Research Consortium, the NSW Office of Health and Medical Research, Amgen, Eisai, and the Pittsburgh Foundation. Dr Higgins is funded by an NHMRC Emerging Leadership Fellowship (GNT2008447). Dr McQuilten is funded by an NHMRC Emerging Leadership Fellowship (APP194811). Dr Gordon is funded by an NIHR Research Professorship (RP-2015-06-18) and Dr Shankar-Hari by an NIHR Clinician Scientist Fellowship (CS-2016-16-011). Dr Turgeon is the Chairholder of the Canada Research Chair in Critical Care Neurology and Trauma. Dr Lawler is supported by a career award from the Heart and Stroke Foundation of Canada., and European Project: 602525,EC:FP7:HEALTH,FP7-HEALTH-2013-INNOVATION-1,PREPARE(2014)
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Adult ,Male ,corticosteroid ,[SDV]Life Sciences [q-bio] ,Critical Illness ,lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4] ,antiplatelet ,Lopinavir ,Adaptive platform trial randomized controlled trial intensive care, pneumonia COVID-19 antiplatelet immunoglobulin antiviral corticosteroid immune modulation anticoagulation ,All institutes and research themes of the Radboud University Medical Center ,Adrenal Cortex Hormones ,Humans ,anticoagulation ,intensive care, pneumonia ,COVID-19 Serotherapy ,Original Investigation ,Medicine(all) ,immune modulation ,Ritonavir ,SARS-CoV-2 ,COVID-19 ,Anticoagulants ,Bayes Theorem ,General Medicine ,Middle Aged ,antiviral ,Receptors, Interleukin-6 ,Adaptive platform trial ,randomized controlled trial ,Female ,Human medicine ,immunoglobulin ,Follow-Up Studies ,Hydroxychloroquine - Abstract
ImportanceThe longer-term effects of therapies for the treatment of critically ill patients with COVID-19 are unknown.ObjectiveTo determine the effect of multiple interventions for critically ill adults with COVID-19 on longer-term outcomes.Design, Setting, and ParticipantsPrespecified secondary analysis of an ongoing adaptive platform trial (REMAP-CAP) testing interventions within multiple therapeutic domains in which 4869 critically ill adult patients with COVID-19 were enrolled between March 9, 2020, and June 22, 2021, from 197 sites in 14 countries. The final 180-day follow-up was completed on March 2, 2022.InterventionsPatients were randomized to receive 1 or more interventions within 6 treatment domains: immune modulators (n = 2274), convalescent plasma (n = 2011), antiplatelet therapy (n = 1557), anticoagulation (n = 1033), antivirals (n = 726), and corticosteroids (n = 401).Main Outcomes and MeasuresThe main outcome was survival through day 180, analyzed using a bayesian piecewise exponential model. A hazard ratio (HR) less than 1 represented improved survival (superiority), while an HR greater than 1 represented worsened survival (harm); futility was represented by a relative improvement less than 20% in outcome, shown by an HR greater than 0.83.ResultsAmong 4869 randomized patients (mean age, 59.3 years; 1537 [32.1%] women), 4107 (84.3%) had known vital status and 2590 (63.1%) were alive at day 180. IL-6 receptor antagonists had a greater than 99.9% probability of improving 6-month survival (adjusted HR, 0.74 [95% credible interval {CrI}, 0.61-0.90]) and antiplatelet agents had a 95% probability of improving 6-month survival (adjusted HR, 0.85 [95% CrI, 0.71-1.03]) compared with the control, while the probability of trial-defined statistical futility (HR >0.83) was high for therapeutic anticoagulation (99.9%; HR, 1.13 [95% CrI, 0.93-1.42]), convalescent plasma (99.2%; HR, 0.99 [95% CrI, 0.86-1.14]), and lopinavir-ritonavir (96.6%; HR, 1.06 [95% CrI, 0.82-1.38]) and the probabilities of harm from hydroxychloroquine (96.9%; HR, 1.51 [95% CrI, 0.98-2.29]) and the combination of lopinavir-ritonavir and hydroxychloroquine (96.8%; HR, 1.61 [95% CrI, 0.97-2.67]) were high. The corticosteroid domain was stopped early prior to reaching a predefined statistical trigger; there was a 57.1% to 61.6% probability of improving 6-month survival across varying hydrocortisone dosing strategies.Conclusions and RelevanceAmong critically ill patients with COVID-19 randomized to receive 1 or more therapeutic interventions, treatment with an IL-6 receptor antagonist had a greater than 99.9% probability of improved 180-day mortality compared with patients randomized to the control, and treatment with an antiplatelet had a 95.0% probability of improved 180-day mortality compared with patients randomized to the control. Overall, when considered with previously reported short-term results, the findings indicate that initial in-hospital treatment effects were consistent for most therapies through 6 months.
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- 2023
13. Feasibility of using a teleconsultation facility (Micro-Health Centre - MHC) in management of CRDs in remote rural area
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Patil, Rutuja, Fairhurst, Karen, McKinstry, Brian, Juvekar, Sanjay, and National Institute for Health and Care Research (NIHR)
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Respiratory physicians ,telehealthcare ,teleconsultation facility ,Micro-Health Centre ,telehealth ,CRD ,rural ,MHC ,Chronic respiratory disease - Abstract
BACKGROUND: Chronic respiratory disease (CRD) is a major public health problem in India with high prevalence and mortality. However, remote rural places have often experienced inequity in access to health care facilities and services. Even where places are equipped with facilities, the availability of trained healthcare providers, particularly respiratory specialists, is challenging. These specialists tend to be concentrated in cities many hours travel from rural patients. Recent technological advances have enabled doctors to deploy telemedicine in remote locations, potentially allowing specialists to support local generalist clinicians. However, multiple barriers still exist to implementing and scaling such technology. It is unclear what services could be delivered and what equipment and clinical and support staff would be required. Nor is it known what the attitudes of specialists, generalist clinicians and patients would be to providing such a service. My study aimed to assess the feasibility of using an established teleconsultation facility (Micro-Health Centre) to provide remote specialist respiratory-physician support to rural primary-physician in CRD diagnosis and management in a resource-constrained rural area. I sought the views and experiences of national and local opinion leaders in telehealth and service delivery in India and the perceptions of local specialist and generalist clinicians on using technology for specialist to non-specialist advice to strengthen existing underutilised teleconsultation services. I then explored how they felt the system and services worked and how they thought it could be further improved. RESEARCH QUESTION: What are the barriers and facilitators to providing remote, specialist respiratory-physician support to rural primary-physician for CRD diagnosis and management? PRIMARY OBJECTIVE: To assess the feasibility of using an established teleconsultation facility (Micro-Health Centre) to provide remote specialist respiratory-physician support to rural primary-physician in CRD diagnosis and management in a resource-constrained rural area. SECONDARY OBJECTIVES: • To explore the evidence for the effective use of specialist to non-specialist teleconsultation in the management of CRDs in adults in remote areas • To determine the requirements, including equipment and skills to support local primary physicians in remote CRD diagnosis and management; • To explore barriers to and facilitators of successful implementation of specialist to non-specialist teleconsultation at Micro Health Centre (MHC) in CRD diagnosis and management from the viewpoints of patients, opinion leaders, primary and respiratory physicians; •Following the use of the teleconsultation service to understand the perception of the patients and health care providers of remotely supported consultations; •To facilitate the strengthening of the existing teleconsultation facility for CRD diagnosis and management. METHODS: I used three main methods; a systematic review of the available literature; one-to-one interviews and focus groups with stakeholders to explore the barriers and facilitators to telehealthcare and what was required to run a successful telehealthcare service that could support local clinicians. I helped design an improved service and negotiated government support and local support based on this. A further series of qualitative interviews and structured questionnaires were conducted to determine the views of Primary Physicians (PP) and patients after they had experienced the system. SYSTEMATIC REVIEW: I systematically searched for articles in Embase, Medline, PubMed and CAB Global health till November 2020, which focused on specialist to non-specialist teleconsultations for CRD diagnosis or management. With a colleague, I assessed the quality of relevant papers using the Joanna Briggs Institute's (JBI) tool. I used a descriptive and narrative approach to analyse these due to the heterogeneous nature of the selected studies. QUALITATIVE STUDY: I interviewed eight opinion leaders who included people already in telehealthcare, experts, researchers and policymakers working in teleconsultation in India. I interviewed healthcare providers, including six Respiratory Physicians (RP), ten Primary Physicians (PP), and 30 patients attending the teleconsultation clinics for respiratory ailments. The data from patients were collected at two time points, pre and post-teleconsultation. I also interviewed the PP coordinating the teleconsultation post their experience using telehealthcare services to consult specialists for patient treatment. Analysis was inductive and iterative. STRENGTHENING OF THE EXISTING FACILITY: The KEMHRC Pune runs a Micro Health Centre (MHC) that provides primary health care to the population. However, it was an underutilised centre that ran only face-to-face outpatient consultations by local PP despite the availability of teleconsultation. I aimed to improve the facility based on the literature and the views of stakeholders. RESULTS: In my systematic review, I found 1715 articles that met the initial search criteria, but after excluding duplicates and non-eligible articles, I included ten research articles of moderate quality. All but one of which were conducted in high-income countries. The teleconsulting systems used in the included papers primarily used audio or video modes. The included studies reported primarily non-clinical outcomes, including effectiveness of using the system, feasibility, acceptability, and usability of the teleconsultation systems and only three described the clinical outcomes. The teleconsultation was predominantly conducted in the PP’s office, with the specialist located remotely. The review concludes that, despite the literature being limited and not generalisable, specialist to non-specialist teleconsultation for diagnosis and management of CRDs should be encouraged, particularly where face-to-face consultations are challenging or unavailable. The results of my qualitative study informed the requirements for the set-up and implementation of a telehealthcare system for CRD diagnosis and management in remote areas. Further, I identified the barriers and facilitators in the diagnosis and management of CRD using telehealthcare. I also documented the stakeholder perspective in using telehealthcare solutions for CRD diagnosis and management. According to the respondents, to be successful, a telehealthcare system must be appropriately located, ideally driven by interested leadership and particularly an inspired coordinator to run the centre with dedicated and motivated human resources and finance. Further, local stakeholder engagement and advertisement was considered essential. The training was observed as one of the most important requirements in the set-up and implementation of telehealthcare. The RPs further thought that primary physicians needed additional training in the diagnosis and management of CRDs, although the RPs did not consider they needed training for teleconsultation. However, not all respondents thought training would be acceptable by both primary physicians and specialists. A similar array of clinical skills and equipment required for a traditional face-to-face consultation was considered necessary for teleconsultation, including patient history, clinical examination and auscultation by a trained physician, and spirometry. Some participants also expressed the need for X-rays, electrocardiograms (ECG), and a facility for blood diagnostics. The participants said that the challenges of telediagnosis are ameliorated not only by training and adequate equipment but also by good record keeping and the ability to share electronic records with a specialist. These findings iteratively informed the strengthening of the existing telehealthcare system. I arranged numerous institutional and regulatory approvals, and I arranged for the functioning of the teleconsultation service by appointing a bi-weekly visit by a primary physician and a technician. The primary physicians were further trained by the respiratory specialists at the tertiary care hospital (KEM Hospital) as the qualitative data informed the training needs for the PPs. Additionally, appropriate diagnostic tools were made available, and the telehealthcare system and software were updated as per the requirements suggested by the doctors and also because the then-existing system was due for maintenance and required repairs which the original service provider was unable to provide. Based on a comparative analysis of existing options I identified a start-up named A3RMT (Anytime Anywhere Access Remote Monitoring Technologies) (https://www.a3rmt.com/), incubated in the Indian Institute of Technology Bombay, which provides technology solutions for telehealthcare to undertake the upgrade. The A3RMT systems have facilities to capture clinical information and transmit this information to doctors using internet connectivity. The installation funding was raised through donations. I also engaged the community by conducting face-to-face meetings with the community leaders and further advertised the facilities available at the centre. This process resulted in a higher patient load and a larger number of teleconsultations. This service was provided free to patients and based on goodwill from clinicians, and scaling would require payment arrangements to be negotiated for primary and secondary care, as would the proportion paid by patients. In conclusion, my PhD has addressed the aim of the study and has generated data to understand the process of setting up and implementing a telehealthcare centre, especially for the diagnosis and management of CRD. The results will help create guidelines for establishing and managing a telehealthcare centre. The COVID pandemic has changed the scenario of the use of telehealthcare globally. The WHO strategy on digital health published in 2020 lays down general and specific principles to implement digital health globally. Telehealthcare will now be widely implemented in low-resource settings given the increase in infrastructure for digital health and the availability of updated technology. Given this background, my study has provided some practical implications for implementing telehealthcare centres for specialists to non-specialists teleconsultations in low-resource settings. These practical implications can be incorporated in the specific guidelines for functioning.
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- 2022
14. Expanding SPTAN1 monoallelic variant associated disorders: From epileptic encephalopathy to pure spastic paraplegia and ataxia
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Heba Morsy, Mehdi Benkirane, Elisa Cali, Clarissa Rocca, Kristina Zhelcheska, Valentina Cipriani, Evangelia Galanaki, Reza Maroofian, Stephanie Efthymiou, David Murphy, Mary O’Driscoll, Mohnish Suri, Siddharth Banka, Jill Clayton-Smith, Thomas Wright, Melody Redman, Jennifer A. Bassetti, Mathilde Nizon, Benjamin Cogne, Rami Abu Jamra, Tobias Bartolomaeus, Marion Heruth, Ilona Krey, Janina Gburek-Augustat, Dagmar Wieczorek, Felix Gattermann, Meriel Mcentagart, Alice Goldenberg, Lucie Guyant-Marechal, Hector Garcia-Moreno, Paola Giunti, Brigitte Chabrol, Severine Bacrot, Roger Buissonnière, Virginie Magry, Vykuntaraju K. Gowda, Varunvenkat M. Srinivasan, Béla Melegh, András Szabó, Katalin Sümegi, Mireille Cossée, Monica Ziff, Russell Butterfield, David Hunt, Georgina Bird-Lieberman, Michael Hanna, Michel Koenig, Michael Stankewich, Jana Vandrovcova, Henry Houlden, J.C. Ambrose, P. Arumugam, E.L. Baple, M. Bleda, F. Boardman-Pretty, J.M. Boissiere, C.R. Boustred, H. Brittain, M.J. Caulfield, G.C. Chan, C.E.H. Craig, L.C. Daugherty, A. de Burca, A. Devereau, G. Elgar, R.E. Foulger, T. Fowler, P. Furió-Tarí, J.M. Hackett, D. Halai, A. Hamblin, S. Henderson, J.E. Holman, T.J.P. Hubbard, K. Ibáñez, R. Jackson, L.J. Jones, D. Kasperaviciute, M. Kayikci, L. Lahnstein, K. Lawson, S.E.A. Leigh, I.U.S. Leong, F.J. Lopez, F. Maleady-Crowe, J. Mason, E.M. McDonagh, L. Moutsianas, M. Mueller, N. Murugaesu, A.C. Need, C.A. Odhams, C. Patch, D. Perez-Gil, D. Polychronopoulos, J. Pullinger, T. Rahim, A. Rendon, P. Riesgo-Ferreiro, T. Rogers, M. Ryten, K. Savage, K. Sawant, R.H. Scott, A. Siddiq, A. Sieghart, D. Smedley, K.R. Smith, A. Sosinsky, W. Spooner, H.E. Stevens, A. Stuckey, R. Sultana, E.R.A. Thomas, S.R. Thompson, C. Tregidgo, A. Tucci, E. Walsh, S.A. Watters, M.J. Welland, E. Williams, K. Witkowska, S.M. Wood, M. Zarowiecki, UCL, Institute of Neurology [London], Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), William Harvey Research Institute, Barts and the London Medical School, Birmingham Women’s and Children’s Hospitals NHS Foundation Trust, Nottingham Clinical Genetics Service, Nottingham University Hospitals NHS Trust, Manchester Centre for Genomic Medicine [Manchester, UK] (MCGM), St Mary's Hospital Manchester-Manchester Academic Health Science Centre (MAHSC), University of Manchester [Manchester]-University of Manchester [Manchester]-Manchester University NHS Foundation Trust (MFT)-Faculty of Biology, Medicine and Health [Manchester, UK], University of Manchester [Manchester], Manchester University NHS Foundation Trust (MFT), Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Trust, Weill Cornell Medicine [New York], unité de recherche de l'institut du thorax UMR1087 UMR6291 (ITX), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), University Hospital Leipzig, University Hospital Düsseldorf, St George’s University Hospitals, Département de génétique [CHU Rouen] (Centre Normandie de Génomique et de Médecine Personnalisée), CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Service de pédiatrie et neurologie pédiatrique, Université de la Méditerranée - Aix-Marseille 2-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), University College London Hospitals NHS Foundation Trust [London, UK] (UCLH), Centre Hospitalier de Versailles André Mignot (CHV), Unité de génétique médicale et oncogénétique [CHU Amiens Picardie], CHU Amiens-Picardie, Auteur indépendant, University of Pécs Medical School (UP MS), University of Pecs, Great Ormond Street Hospital for Children NHS Foundation Trust [London, UK] (GOSHC), University of Utah School of Medicine [Salt Lake City], Princess Anne Hospital [Southampton, UK] (PAH), University of Southampton, University Hospital Southampton NHS Foundation Trust, Department of Pathology [Yale], Yale School of Medicine [New Haven, Connecticut] (YSM), H.M., J.V., and H.H. are supported by an Medical Research Council strategic award, MR/S005021/1, to establish International Centre for Genomic Medicine in Neuromuscular Diseases. H.M. is supported by Wellcome Trust grant 220906/Z/20/Z. H.H. is funded by the Medical Research Council (MR/S01165X/1, MR/S005021/1, G0601943), NIHR University College London Hospitals Biomedical Research Centre, Rosetree Trust UK, Ataxia UK, Multiple System Atrophy Trust, Brain Research UK, Sparks GOSH Charity, Muscular Dystrophy UK, and Multiple System Atrophy Trust. R.But. is supported by the Penelope Rare and Undiagnosed Disease Program at the University of Utah with funding from the Center for Genomic Medicine and with support from Matt Velinder (Department of Human Genetics, University of Utah) and Rong Mao and Pinar Bayrak-Toydemir (ARUP Laboratories). B.M. is supported by NKFIH K138669. This research was made possible through access to the data and findings generated by the 100,000 Genomes Project. The 100,000 Genomes Project is managed by Genomics England Limited (a wholly owned company of the Department of Health and Social Care). The 100,000 Genomes Project is funded by the National Institute for Health and Care Research and NHS England. The Wellcome Trust, Cancer Research UK, and the Medical Research Council have also funded the research infrastructure. The 100,000 Genomes Project uses data provided by patients and collected by the National Health Service as part of their care and support. This study makes use of data generated by the DatabasE of genomiC varIation and Phenotype in Humans using Ensembl Resources (DECIPHER) community. A full list of centers which contributed to the generation of the data is available at https://deciphergenomics.org/about/stats and via email from contact@deciphergenomics.org. Funding for the DECIPHER project was provided by Wellcome. We are thankful to the Deciphering Developmental Disorders Study for the invaluable collaboration. The Deciphering Developmental Disorders Study (Cambridge South Research Ethics Committee approval 10/H0305/83 and the Republic of Ireland Research Ethics Committee GEN/284/12) presents independent research commissioned by the Health Innovation Challenge Fund (grant number HICF-1009-003), a parallel funding partnership between the Wellcome Trust and Department of Health and the Wellcome Trust Sanger Institute (grant number WT098051), MORNET, Dominique, Nottingham University Hospitals NHS Trust (NUH), Weill Cornell Medicine [Cornell University], and Cornell University [New York]
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[SDV] Life Sciences [q-bio] ,Developmental delay ,[SDV]Life Sciences [q-bio] ,Hereditary spastic paraplegia ,Genetics (clinical) ,Hereditary ataxia ,SPTAN1 ,Developmental epileptic encephalopathy - Abstract
On behalf of Queen Square Genomics On behalf of Genomics England Research Consortium; International audience; Purpose: Nonerythrocytic αII-spectrin (SPTAN1) variants have been previously associated with intellectual disability and epilepsy. We conducted this study to delineate the phenotypic spectrum of SPTAN1 variants.Methods: We carried out SPTAN1 gene enrichment analysis in the rare disease component of the 100,000 Genomes Project and screened 100,000 Genomes Project, DECIPHER database, and GeneMatcher to identify individuals with SPTAN1 variants. Functional studies were performed on fibroblasts from 2 patients.Results: Statistically significant enrichment of rare (minor allele frequency < 1 × 10-5) probably damaging SPTAN1 variants was identified in families with hereditary ataxia (HA) or hereditary spastic paraplegia (HSP) (12/1142 cases vs 52/23,847 controls, p = 2.8 × 10-5). We identified 31 individuals carrying SPTAN1 heterozygous variants or deletions. A total of 10 patients presented with pure or complex HSP/HA. The remaining 21 patients had developmental delay and seizures. Irregular αII-spectrin aggregation was noted in fibroblasts derived from 2 patients with p.(Arg19Trp) and p.(Glu2207del) variants.Conclusion: We found that SPTAN1 is a genetic cause of neurodevelopmental disorder, which we classified into 3 distinct subgroups. The first comprises developmental epileptic encephalopathy. The second group exhibits milder phenotypes of developmental delay with or without seizures. The final group accounts for patients with pure or complex HSP/HA.
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15. Effect of priming interval on reactogenicity, peak immunological response, and waning after homologous and heterologous COVID-19 vaccine schedules: exploratory analyses of Com-COV, a randomised control trial
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Robert H Shaw, Xinxue Liu, Arabella S V Stuart, Melanie Greenland, Parvinder K Aley, Nick J Andrews, J Claire Cameron, Sue Charlton, Elizabeth A Clutterbuck, Andrea M Collins, Wanwisa Dejnirattisai, Tanya Dinesh, Saul N Faust, Daniela M Ferreira, Adam Finn, Christopher A Green, Bassam Hallis, Paul T Heath, Helen Hill, Teresa Lambe, Rajeka Lazarus, Vincenzo Libri, Fei Long, Yama F Mujadidi, Emma L Plested, Ella R Morey, Samuel Provstgaard-Morys, Maheshi N Ramasamy, Mary Ramsay, Robert C Read, Hannah Robinson, Gavin R Screaton, Nisha Singh, David P J Turner, Paul J Turner, Iason Vichos, Laura L Walker, Rachel White, Jonathan S Nguyen-Van-Tam, Matthew D Snape, Alasdair P.S. Munro, Jazz Bartholomew, Laura Presland, Sarah Horswill, Sarah Warren, Sophie Varkonyi-Clifford, Stephen Saich, Kirsty Adams, Marivic Ricamara, Nicola Turner, Nicole Y. Yee Ting, Sarah Whittley, Tommy Rampling, Amisha Desai, Claire H. Brown, Ehsaan Qureshi, Karishma Gokani, Kush Naker, Johanna K. Kellett Wright, Rachel L. Williams, Tawassal Riaz, Florentina D. Penciu, Amy Carson, Claudio Di Maso, Gracie Mead, Elizabeth G. Howe, Mujtaba Ghulam Farooq, Rabiullah Noristani, Xin L. Yao, Neil J. Oldfield, Daniel Hammersley, Sue Belton, Simon Royal, Alberto San Francisco Ramos, Cecilia Hultin, Eva P. Galiza, Rebecca Crook, Marcin Bula, Fred Fyles, Hassan Burhan, Flora Maelin, Elen Hughes, Emmanuel Okenyi, Group, Com-COV Study, and National Institute for Health and Care Research
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Pulmonary and Respiratory Medicine ,Adult ,COVID-19 Vaccines ,wa_115 ,SARS-CoV-2 ,COVID-19/prevention & control ,Com-COV Study Group ,Immunization, Secondary ,COVID-19 ,Covid19 ,1103 Clinical Sciences ,Antibodies, Viral ,qw_806 ,qw_805 ,1117 Public Health and Health Services ,ChAdOx1 nCoV-19 ,Immunoglobulin G ,wc_506 ,Humans ,BNT162 Vaccine ,COVID-19 Vaccines/adverse effects ,1199 Other Medical and Health Sciences - Abstract
Background Priming COVID-19 vaccine schedules have been deployed at variable intervals globally, which might influence immune persistence and the relative importance of third-dose booster programmes. Here, we report exploratory analyses from the Com-COV trial, assessing the effect of 4-week versus 12-week priming intervals on reactogenicity and the persistence of immune response up to 6 months after homologous and heterologous priming schedules using the vaccines BNT162b2 (tozinameran, Pfizer/BioNTech) and ChAdOx1 nCoV-19 (AstraZeneca). Methods Com-COV was a participant-masked, randomised immunogenicity trial. For these exploratory analyses, we used the trial's general cohort, in which adults aged 50 years or older were randomly assigned to four homologous and four heterologous vaccine schedules using BNT162b2 and ChAdOx1 nCoV-19 with 4-week or 12-week priming intervals (eight groups in total). Immunogenicity analyses were done on the intention-to-treat (ITT) population, comprising participants with no evidence of SARS-CoV-2 infection at baseline or for the trial duration, to assess the effect of priming interval on humoral and cellular immune response 28 days and 6 months post-second dose, in addition to the effects on reactogenicity and safety. The Com-COV trial is registered with the ISRCTN registry, 69254139 (EudraCT 2020–005085–33). Findings Between Feb 11 and 26, 2021, 730 participants were randomly assigned in the general cohort, with 77–89 per group in the ITT analysis. At 28 days and 6 months post-second dose, the geometric mean concentration of anti-SARS-CoV-2 spike IgG was significantly higher in the 12-week interval groups than in the 4-week groups for homologous schedules. In heterologous schedule groups, we observed a significant difference between intervals only for the BNT162b2–ChAdOx1 nCoV-19 group at 28 days. Pseudotyped virus neutralisation titres were significantly higher in all 12-week interval groups versus 4-week groups, 28 days post-second dose, with geometric mean ratios of 1·4 (95% CI 1·1–1·8) for homologous BNT162b2, 1·5 (1·2–1·9) for ChAdOx1 nCoV-19–BNT162b2, 1·6 (1·3–2·1) for BNT162b2–ChAdOx1 nCoV-19, and 2·4 (1·7–3·2) for homologous ChAdOx1 nCoV-19. At 6 months post-second dose, anti-spike IgG geometric mean concentrations fell to 0·17–0·24 of the 28-day post-second dose value across all eight study groups, with only homologous BNT162b2 showing a slightly slower decay for the 12-week versus 4-week interval in the adjusted analysis. The rank order of schedules by humoral response was unaffected by interval, with homologous BNT162b2 remaining the most immunogenic by antibody response. T-cell responses were reduced in all 12-week priming intervals compared with their 4-week counterparts. 12-week schedules for homologous BNT162b2 and ChAdOx1 nCoV-19–BNT162b2 were up to 80% less reactogenic than 4-week schedules. Interpretation These data support flexibility in priming interval in all studied COVID-19 vaccine schedules. Longer priming intervals might result in lower reactogenicity in schedules with BNT162b2 as a second dose and higher humoral immunogenicity in homologous schedules, but overall lower T-cell responses across all schedules. Future vaccines using these novel platforms might benefit from schedules with long intervals. Funding UK Vaccine Taskforce and National Institute for Health and Care Research.
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16. The Psychosis Metabolic Risk Calculator (PsyMetRiC) for Young People with Psychosis: International External Validation and Site-Specific Recalibration in Two Independent European Samples
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Benjamin I. Perry, Frederik Vandenberghe, Nathalia Garrido-Torres, Emanuele F. Osimo, Marianna Piras, Javier Vazquez-Bourgon, Rachel Upthegrove, Claire Grosu, Victor Ortiz-Garcia De La Foz, Peter B. Jones, Nermine Laaboub, Miguel Ruiz-Veguilla, Jan Stochl, Celine Dubath, Manuel Canal-Rivero, Pavan Mallikarjun, Aurélie Delacrétaz, Nicolas Ansermot, Emilio Fernandez-Egea, Severine Crettol, Franziska Gamma, Kerstin J. Plessen, Philippe Conus, Golam M. Khandaker, Graham K. Murray, Chin B. Eap, Benedicto Crespo-Facorro, Osimo, Emanuele F [0000-0001-6239-5691], Apollo - University of Cambridge Repository, National Institute for Health and Care Research (US), Cambridge Biomedical Research Centre, Wellcome Trust, Swiss National Science Foundation, Instituto de Salud Carlos III, Junta de Andalucía, Fundació Seny, Fundación Marques de Valdecilla, Ministerio de Economía y Competitividad (España), Perry, Benjamin I., Vandenberghe, Frederik, Osimo, Emanuele F., Perry, BI [0000-0002-1533-026X], Vandenberghe, F [0000-0002-8964-2047], and Osimo, EF [0000-0001-6239-5691]
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Metabolic Syndrome ,PsyMetab ,Oncology ,Health Policy ,Early Intervention ,Internal Medicine ,PAFIP ,International Validation ,Psychosis ,Risk Prediction Algorithm - Abstract
[Background]: Cardiometabolic dysfunction is common in young people with psychosis. Recently, the Psychosis Metabolic Risk Calculator (PsyMetRiC) was developed and externally validated in the UK, predicting up-to six-year risk of metabolic syndrome (MetS) from routinely collected data. The full-model includes age, sex, ethnicity, body-mass index, smoking status, prescription of metabolically-active antipsychotic medication, high-density lipoprotein, and triglyceride concentrations; the partial-model excludes biochemical predictors., [Methods]: To move toward a future internationally-useful tool, we externally validated PsyMetRiC in two independent European samples. We used data from the PsyMetab (Lausanne, Switzerland) and PAFIP (Cantabria, Spain) cohorts, including participants aged 16–35y without MetS at baseline who had 1–6y follow-up. Predictive performance was assessed primarily via discrimination (C-statistic), calibration (calibration plots), and decision curve analysis. Site-specific recalibration was considered., [Findings]: We included 1024 participants (PsyMetab n=558, male=62%, outcome prevalence=19%, mean follow-up=2.48y; PAFIP n=466, male=65%, outcome prevalence=14%, mean follow-up=2.59y). Discrimination was better in the full- compared with partial-model (PsyMetab=full-model C=0.73, 95% C.I., 0.68–0.79, partial-model C=0.68, 95% C.I., 0.62–0.74; PAFIP=full-model C=0.72, 95% C.I., 0.66–0.78; partial-model C=0.66, 95% C.I., 0.60–0.71). As expected, calibration plots revealed varying degrees of miscalibration, which recovered following site-specific recalibration. PsyMetRiC showed net benefit in both new cohorts, more so after recalibration., [Interpretation]: The study provides evidence of PsyMetRiC's generalizability in Western Europe, although further local and international validation studies are required. In future, PsyMetRiC could help clinicians internationally to identify young people with psychosis who are at higher cardiometabolic risk, so interventions can be directed effectively to reduce long-term morbidity and mortality., NIHR Cambridge Biomedical Research Centre (BRC-1215-20014); The Wellcome Trust (201486/Z/16/Z); Swiss National Research Foundation (320030-120686, 324730- 144064, and 320030-173211); The Carlos III Health Institute (CM20/00015, FIS00/3095, PI020499, PI050427, and PI060507); IDIVAL (INT/A21/10 and INT/A20/04); The Andalusian Regional Government (A1-0055-2020 and A1-0005-2021); SENY Fundacion Research (2005-0308007); Fundacion Marques de Valdecilla (A/02/07, API07/011); Ministry of Economy and Competitiveness and the European Fund for Regional Development (SAF2016-76046-R and SAF2013-46292-R).
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17. Fluorescent Multifunctional Organic Nanoparticles for Drug Delivery and Bioimaging: A Tutorial Review
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Guillem Vargas-Nadal, Mariana Köber, Audrey Nsamela, Francesca Terenziani, Cristina Sissa, Silvia Pescina, Fabio Sonvico, Amirah Mohd Gazzali, Habibah A. Wahab, Luca Grisanti, María Eugenia Olivera, María Celeste Palena, María Laura Guzman, Laura Carolina Luciani-Giacobbe, Alvaro Jimenez-Kairuz, Nora Ventosa, Imma Ratera, Kevin D. Belfield, Ben M. Maoz, European Commission, Ministerio de Ciencia, Innovación y Universidades (España), National Science Foundation (US), National Institute for Health and Care Research (US), and Ministerio de Economía y Competitividad (España)
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Fluorescence microscopy ,Organic nanoparticles ,Drug delivery ,Pharmaceutical Science ,FONs manufacturing ,Theoretical simulations of nanoparticles ,Fluorophores ,fluorescence ,organic nanoparticles ,drug delivery ,bioimaging ,fluorophores ,fluorescence microscopy ,theoretical simulations of nanoparticles ,Bioimaging ,Fluorescence - Abstract
Fluorescent organic nanoparticles (FONs) are a large family of nanostructures constituted by organic components that emit light in different spectral regions upon excitation, due to the presence of organic fluorophores. FONs are of great interest for numerous biological and medical applications, due to their high tunability in terms of composition, morphology, surface functionalization, and optical properties. Multifunctional FONs combine several functionalities in a single nanostructure (emission of light, carriers for drug-delivery, functionalization with targeting ligands, etc.), opening the possibility of using the same nanoparticle for diagnosis and therapy. The preparation, characterization, and application of these multifunctional FONs require a multidisciplinary approach. In this review, we present FONs following a tutorial approach, with the aim of providing a general overview of the different aspects of the design, preparation, and characterization of FONs. The review encompasses the most common FONs developed to date, the description of the most important features of fluorophores that determine the optical properties of FONs, an overview of the preparation methods and of the optical characterization techniques, and the description of the theoretical approaches that are currently adopted for modeling FONs. The last part of the review is devoted to a non-exhaustive selection of some recent biomedical applications of FONs., This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowka-Curie grant agreement No. 101007804 (Micro4Nano). M.K., N.V., and I.R. acknowledge financial support from the Spanish Ministry of Science and Innovation through the Severo Ochoa Program for Centers of Excellence in R&D (SEV-2015-0496 and CEX2019-000917-S) and through the grant “MOL4BIO” (PID2019-105622RB-I00). K.D.B acknowledges support from the US National Science Foundation (EFMA-2203704) and the National Institutes of Health (R21AA028340)., With funding from the Spanish government through the ‘Severo Ochoa Centre of Excellence’ accreditation (CEX2019-000917-S).
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18. Dipeptide Repeat Pathology in C9orf72-ALS Is Associated with Redox, Mitochondrial and NRF2 Pathway Imbalance
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José Jiménez-Villegas, Janine Kirby, Ana Mata, Susana Cadenas, Martin R. Turner, Andrea Malaspina, Pamela J. Shaw, Antonio Cuadrado, Ana I. Rojo, Ministerio de Ciencia, Innovación y Universidades (España), Agencia Estatal de Investigación (España), Fundación Tatiana Pérez de Guzmán el Bueno, Medical Research Council (UK), Instituto de Salud Carlos III, Universidad Autónoma de Madrid, Motor Neuron Disease Association, National Institute for Health and Care Research (US), and European Cooperation in Science and Technology
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Physiology ,C9orf72 ,Clinical Biochemistry ,NRF2 ,amyotrophic lateral sclerosis ,dipeptide repeat proteins ,Dipeptide repeat proteins ,Cell Biology ,Amyotrophic lateral sclerosis ,Molecular Biology ,Biochemistry - Abstract
The hexanucleotide expansion of the C9orf72 gene is found in 40% of familial amyotrophic lateral sclerosis (ALS) patients. This genetic alteration has been connected with impaired management of reactive oxygen species. In this study, we conducted targeted transcriptional profiling in leukocytes from C9orf72 patients and control subjects by examining the mRNA levels of 84 redox-related genes. The expression of ten redox genes was altered in samples from C9orf72 ALS patients compared to healthy controls. Considering that Nuclear factor erythroid 2-Related Factor 2 (NRF2) modulates the expression of a wide range of redox genes, we further investigated its status on an in vitro model of dipeptide repeat (DPR) toxicity. This model mimics the gain of function, toxic mechanisms attributed to C9orf72 pathology. We found that exposure to DPRs increased superoxide levels and reduced mitochondrial potential as well as cell survival. Importantly, cells overexpressing DPRs exhibited reduced protein levels of NRF2 and its target genes upon inhibition of the proteasome or its canonical repressor, the E3 ligase adapter KEAP1. However, NRF2 activation was sufficient to recover cell viability and redox homeostasis. This study identifies NRF2 as a putative target in precision medicine for the therapy of ALS patients harboring C9orf72 expansion repeats., This work was supported by the SAF2019-110061RB-100 grant from the Spanish Ministry of Economy and Competitiveness; P-024-FTPGB 2018 from the Spanish Foundation named “Tatiana de Guzman el Bueno”, COEN-2018-Pathfinder phase III financed by the Network of Centers of Excellence in Neurodegeneration including the UK Medical Research Council and PI19/01030 financed by the Spanish “Instituto de Salud Carlos III”. J.J.V. hold an FPU PhD fellowship from the Spanish Ministry of Universities (FPU20/03326) and was a holder of a master’s degree fellowship (“Ayudas para el fomento de la Investigación en Estudios de Máster-UAM 2020”) funded by the Autonomous University of Madrid. This research was also supported by the Motor Neurone Disease Association (AMBRoSIA 972-797 and NECTAR 974-797 awards) and by the NIHR Sheffield Biomedical Research Centre (JS-BRC-1215-20017). This article is based upon work from COST Action CA20121, supported by COST (European Cooperation in Science and Technology).
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19. Towards a tricorder: clinical, health economic, and ethical investigation of point-of-care artificial intelligence electrocardiogram for heart failure
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Bachtiger, Patrik, Peters, Nicholas, Imperial Health Charity, National Institute for Health and Care Research, and British Heart Foundation
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Heart failure (HF) is an international public health priority and a focus of the NHS Long Term Plan. There is a particular need in primary care for screening and early detection of heart failure with reduced ejection fraction (HFrEF) – the most common and serious HF subtype, and the only one with an abundant evidence base for effective therapies. Digital health technologies (DHTs) integrating artificial intelligence (AI) could improve diagnosis of HFrEF. Specifically, through a convergence of DHTs and AI, a single-lead electrocardiogram (ECG) can be recorded by a smart stethoscope and interrogated by AI (AI-ECG) to potentially serve as a point-of-care HFrEF test. However, there are concerning evidence gaps for such DHTs applying AI; across intersecting clinical, health economic, and ethical considerations. My thesis therefore investigates hypotheses that AI-ECG is 1.) Reliable, accurate, unbiased, and can be patient self-administered, 2.) Of justifiable health economic impact for primary care deployment, and 3.) Appropriate across ethical domains for deployment as a tool for patient self-administered screening. The theoretical basis for this work is presented in the Introduction (Chapter 1). Chapter 2 describes the first large-scale, multi-centre independent external validation study of AI-ECG, prospectively recruiting 1,050 patients and highlighting impressive performance: area under the curve, sensitivity, and specificity up to 0·91 (95% confidence interval: 0·88–0·95), 91·9% (78·1–98·3), and 80·2% (75·5–84·3) respectively; and absence of bias by age, sex, and ethnicity. Performance was independent of operator, and usability of the tool extended to patients being able to self-examine. Chapter 3 presents a clinical and health economic outcomes analysis using a contemporary digital repository of 2.5 million NHS patient records. A propensity-matched cohort was derived using all patients diagnosed with HF from 2015-2020 (n = 34,208). Novel findings included the unacceptable reality that 70% of index HF diagnoses are made through hospitalisation; where index diagnosis through primary care conferred a medium-term survival advantage and long-term cost saving (£2,500 per patient). This underpins a health economic model for the deployment of AI-ECG across primary care. Chapter 4 approaches a normative ethical analysis focusing on equity, agency, data rights, and responsibility for safe, effective, and trustworthy implementation of an unprecedented at-home patient self-administered AI-ECG screening programme. I propose approaches to mitigating any potential harms, towards preserving and promoting trust, patient engagement, and public health. Collectively, this thesis marks novel work highlighting AI-ECG as tool with the potential to address major cardiovascular public health priorities. Scrutiny through complimentary clinical, health economic, and ethical considerations can directly serve patients and health systems by blueprinting best-practice for the evaluation and implementation of DHTs integrating AI – building the conviction needed to realise the full potential of such technologies. Open Access
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20. Virtual Ontogeny of Cortical Growth Preceding Mental Illness
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Yash Patel, Jean Shin, Christoph Abé, Ingrid Agartz, Clara Alloza, Dag Alnæs, Sonia Ambrogi, Linda A. Antonucci, Celso Arango, Volker Arolt, Guillaume Auzias, Rosa Ayesa-Arriola, Nerisa Banaj, Tobias Banaschewski, Cibele Bandeira, Zeynep Başgöze, Renata Basso Cupertino, Claiton H.D. Bau, Jochen Bauer, Sarah Baumeister, Fabio Bernardoni, Alessandro Bertolino, Caterina del Mar Bonnin, Daniel Brandeis, Silvia Brem, Jason Bruggemann, Robin Bülow, Juan R. Bustillo, Sara Calderoni, Rosa Calvo, Erick J. Canales-Rodríguez, Dara M. Cannon, Susanna Carmona, Vaughan J. Carr, Stanley V. Catts, Sneha Chenji, Qian Hui Chew, David Coghill, Colm G. Connolly, Annette Conzelmann, Alexander R. Craven, Benedicto Crespo-Facorro, Kathryn Cullen, Andreas Dahl, Udo Dannlowski, Christopher G. Davey, Christine Deruelle, Covadonga M. Díaz-Caneja, Katharina Dohm, Stefan Ehrlich, Jeffery Epstein, Tracy Erwin-Grabner, Lisa T. Eyler, Jennifer Fedor, Jacqueline Fitzgerald, William Foran, Judith M. Ford, Lydia Fortea, Paola Fuentes-Claramonte, Janice Fullerton, Lisa Furlong, Louise Gallagher, Bingchen Gao, Si Gao, Jose M. Goikolea, Ian Gotlib, Roberto Goya-Maldonado, Hans J. Grabe, Melissa Green, Eugenio H. Grevet, Nynke A. Groenewold, Dominik Grotegerd, Oliver Gruber, Jan Haavik, Tim Hahn, Ben J. Harrison, Walter Heindel, Frans Henskens, Dirk J. Heslenfeld, Eva Hilland, Pieter J. Hoekstra, Sarah Hohmann, Nathalie Holz, Fleur M. Howells, Jonathan C. Ipser, Neda Jahanshad, Babette Jakobi, Andreas Jansen, Joost Janssen, Rune Jonassen, Anna Kaiser, Vasiliy Kaleda, James Karantonis, Joseph A. King, Tilo Kircher, Peter Kochunov, Sheri-Michelle Koopowitz, Mikael Landén, Nils Inge Landrø, Stephen Lawrie, Irina Lebedeva, Beatriz Luna, Astri J. Lundervold, Frank P. MacMaster, Luigi A. Maglanoc, Daniel H. Mathalon, Colm McDonald, Andrew McIntosh, Susanne Meinert, Patricia T. Michie, Philip Mitchell, Ana Moreno-Alcázar, Bryan Mowry, Filippo Muratori, Leila Nabulsi, Igor Nenadić, Ruth O'Gorman Tuura, Jaap Oosterlaan, Bronwyn Overs, Christos Pantelis, Mara Parellada, Jose C. Pariente, Paul Pauli, Giulio Pergola, Francesco Maria Piarulli, Felipe Picon, Fabrizio Piras, Edith Pomarol-Clotet, Clara Pretus, Yann Quidé, Joaquim Radua, J. Antoni Ramos-Quiroga, Paul E. Rasser, Andreas Reif, Alessandra Retico, Gloria Roberts, Susan Rossell, Diego Luiz Rovaris, Katya Rubia, Matthew D. Sacchet, Josep Salavert, Raymond Salvador, Salvador Sarró, Akira Sawa, Ulrich Schall, Rodney Scott, Pierluigi Selvaggi, Tim Silk, Kang Sim, Antonin Skoch, Gianfranco Spalletta, Filip Spaniel, Dan J. Stein, Olaf Steinsträter, Aleks Stolicyn, Yoichiro Takayanagi, Leanne Tamm, Maria Tavares, Alexander Teumer, Katharina Thiel, Sophia I. Thomopoulos, David Tomecek, Alexander S. Tomyshev, Diana Tordesillas-Gutiérrez, Michela Tosetti, Anne Uhlmann, Tamsyn Van Rheenen, Javier Vazquez-Bourgón, Meike W. Vernooij, Eduard Vieta, Oscar Vilarroya, Cynthia Weickert, Thomas Weickert, Lars T. Westlye, Heather Whalley, David Willinger, Alexandra Winter, Katharina Wittfeld, Tony T. Yang, Yuliya Yoncheva, Jendé L. Zijlmans, Martine Hoogman, Barbara Franke, Daan van Rooij, Jan Buitelaar, Christopher R.K. Ching, Ole A. Andreassen, Elena Pozzi, Dick Veltman, Lianne Schmaal, Theo G.M. van Erp, Jessica Turner, F. Xavier Castellanos, Zdenka Pausova, Paul Thompson, Tomas Paus, Pediatric surgery, Anatomy and neurosciences, Psychiatry, Amsterdam Neuroscience - Brain Imaging, Amsterdam Neuroscience - Mood, Anxiety, Psychosis, Stress & Sleep, General Paediatrics, ARD - Amsterdam Reproduction and Development, Paediatrics, Radiology & Nuclear Medicine, Epidemiology, Clinical Cognitive Neuropsychiatry Research Program (CCNP), German Research Foundation, University of Münster, National Health and Medical Research Council (Australia), University of Cape Town, National Research Foundation (South Africa), Swinburne Universit, Jack Brockhoff Foundation, University of Melbourne, Barbara Dicker Brain Sciences Foundation, Rebecca L. Cooper Foundation, Society of Mental Health Research, Swedish Research Council, Swedish Foundation for Strategic Research, Swedish Brain Foundation, Health Research Board (Ireland), Russian Foundation for Basic Research, University of Zurich, Pratt Foundation, Ramsay Health Care, Viertel Charitable Foundation, Schizophrenia Research Institute, European Commission, Australian Research Council, Instituto de Salud Carlos III, National Institute for Health and Care Research (US), National Institute for Health Research (UK), Ministry of Health of the Czech Republic, Bill & Melinda Gates Foundation, South African Medical Research Council, Carnegie Corporation of New York, Wellcome Trust, Medical Research Council (UK), Medical Research Scotland, Netherlands Organization for Scientific Research, Ambrogi, Sonia, Banaschewski, Tobias, Bandeira, Cibele Edom, Cupertino, Renata, Calderoni, Sara, Cannon, Dara, Carr, Vaughan, Chew, Qian Hui, Coghill, David, Cullen, Kathryn, Dahl, Andreas, Epstein, Jeffery, Foran, William, Fortea, Lydia, Fuentes-Claramonte, Paola, Fullerton, Janice M., Furlong, Lisa, Gallagher, Louise, Gao, Si, Gotlib, Ian, Haavik, Jan, Henskens, Frans, Hilland, Eva, Hoekstra, Pieter J, Howells, Fleur M, Ipser, Jonathan, Jørgensen, Jes Kristian, Karantonis, James A., Lawrie, Stephen, Research Institute of the Hospital for Sick Children and University of Toronto, University of Toronto, Departments of Physiology and Nutritional Sciences, University of Toronto, Toronto, Canada, KG Jebsen Centre for Psychosis Research, University of Oslo (UiO)-Institute of Clinical Medicine-Oslo University Hospital [Oslo], Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), Mental Health Sciences Unit, University College of London [London] (UCL), Institut de Neurosciences de la Timone (INT), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Clinical and Behavioral Neurology - Neuroscienze e riabilitazione, IRCCS Fondazione Santa Lucia [Roma], Heidelberg University, Universidade Federal do Rio Grande do Sul [Porto Alegre] (UFRGS), Universität Heidelberg [Heidelberg] = Heidelberg University, Clinical Neuropsychology, IBBA, APH - Mental Health, Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Hospital Sant Joan de Déu [Barcelona], and Centro de Investigación Biomédica en Red Salud Mental [Madrid] (CIBER-SAM)
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Bipolar Disorder ,Autism Spectrum Disorder ,[SDV]Life Sciences [q-bio] ,Neurogenesis ,pathology [Premature Birth] ,Neurodevelopment ,Cortical surface area ,pathology [Autism Spectrum Disorder] ,Cortical growth ,methods [Magnetic Resonance Imaging] ,SDG 3 - Good Health and Well-being ,Pregnancy ,130 000 Cognitive Neurology & Memory ,Humans ,ddc:610 ,Child ,Biological Psychiatry ,Cerebral Cortex ,pathology [Depressive Disorder, Major] ,Depressive Disorder, Major ,Neurodevelopmental disorders Donders Center for Medical Neuroscience [Radboudumc 7] ,Infant, Newborn ,Magnetic Resonance Imaging ,Mental illness ,Attention Deficit Disorder with Hyperactivity ,Premature Birth ,genetics [Autism Spectrum Disorder] ,Female ,Psychiatric disorders ,170 000 Motivational & Cognitive Control - Abstract
[Background]: Morphology of the human cerebral cortex differs across psychiatric disorders, with neurobiology and developmental origins mostly undetermined. Deviations in the tangential growth of the cerebral cortex during pre/perinatal periods may be reflected in individual variations in cortical surface area later in life., [Methods]: Interregional profiles of group differences in surface area between cases and controls were generated using T1-weighted magnetic resonance imaging from 27,359 individuals including those with attention-deficit/hyperactivity disorder, autism spectrum disorder, bipolar disorder, major depressive disorder, schizophrenia, and high general psychopathology (through the Child Behavior Checklist). Similarity of interregional profiles of group differences in surface area and prenatal cell-specific gene expression was assessed., [Results]: Across the 11 cortical regions, group differences in cortical area for attention-deficit/hyperactivity disorder, schizophrenia, and Child Behavior Checklist were dominant in multimodal association cortices. The same interregional profiles were also associated with interregional profiles of (prenatal) gene expression specific to proliferative cells, namely radial glia and intermediate progenitor cells (greater expression, larger difference), as well as differentiated cells, namely excitatory neurons and endothelial and mural cells (greater expression, smaller difference). Finally, these cell types were implicated in known pre/perinatal risk factors for psychosis. Genes coexpressed with radial glia were enriched with genes implicated in congenital abnormalities, birth weight, hypoxia, and starvation. Genes coexpressed with endothelial and mural genes were enriched with genes associated with maternal hypertension and preterm birth., [Conclusions]: Our findings support a neurodevelopmental model of vulnerability to mental illness whereby prenatal risk factors acting through cell-specific processes lead to deviations from typical brain development during pregnancy., This work was supported by the German Research Foundation (DFG Grant Nos. HA7070/2-2, HA7070/3, HA7070/4 [to TH]) and IZKF of the medical faculty of Münster (Grants No. Dan3/012/17 [to UD] and MzH 3/020/20 [to TH]), and NHMRC projects (Grant No. 1064643 [to BJH] and 1024570 [to CGD]). The CIAM study was supported by the University of Cape Town Research Committee, South African National Research Foundation, and the South African Medical Research Council (principal investigator [PI], Fleur M. Howells) and Grant No. R01MH117601 (to NJ). This work was funded by the German Research Foundation (Grant Nos. FOR2107 JA 1890/7-1 and FOR2107 JA 1890/7-2 [to AJ]) and Swinburne University scholarship/Australian Postgraduate Award (to JK). Collection of the COGSBD cohort was funded by the Jack Brockhoff Foundation, University of Melbourne, Barbara Dicker Brain Sciences Foundation, Rebecca L Cooper Foundation, and the Society of Mental Health Research (to JK). This work was funded by the German Research Foundation (Grant Nos. FOR2107 KI588/14-1 and FOR2107 KI588/14-2 [to TK]). The St. Göran study was supported by grants from the Swedish Research Council (Grant No. 2018-02653 [to ML]), the Swedish foundation for Strategic Research (Grant No. KF10-0039 [to ML]), the Swedish Brain foundation (Grant No. FO2020-0261 [to ML]), and the Swedish Government under the LUA/ALF agreement (Grant Nos. ALF 20170019 and ALFGBG-716801 [to ML]). This work was supported by RFBR (Grant No. 20-013-00748 [to IL, AST]) and funded by the Health Research Board (Grant No. HRA_POR/2011/100 [to CM]). The Australian Schizophrenia Research Bank (ASRB) was supported by the NHMRC (Enabling Grant No. 386500), the Pratt Foundation, Ramsay Health Care, the Viertel Charitable Foundation, and the Schizophrenia Research Institute. Chief investigators for ASRB were VC, US, RSc, AJ, BM, PTM, SVC, FH, and CPa. This work was supported by Deutsche Forschungsgemeinschaft (Grant Nos. DFG NE 2254/2-1, NE 2254/3-1, NE2254/4-1 [to IN]), the University Research Priority Program “Integrative Human Physiology” at the University of Zurich (to ROT), an NHMRC Senior Principal Research Fellowship (Grant No. 1105825 [to CPa]), an NHMRC L3 Investigator Grant (Grant No. 1196508 [to CPa]), and NHMRC Program Grant (Grant No. 1150083 [to CPa]). ASRB was supported by the NHMRC (Enabling Grant No. 386500), the Pratt Foundation, Ramsay Health Care, the Viertel Charitable Foundation and the Schizophrenia Research Institute. Chief investigators for ASRB were VC, US, RSc, AJ, BM, PTM, SVC, FH, and CPa. This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant (Agreement No. 798181 [to GP]). ASRB was supported by the NHMRC (Enabling Grant, ID 386500), the Pratt Foundation, Ramsay Health Care, the Viertel Charitable Foundation and the Schizophrenia Research Institute. Chief investigators for ASRB were VC, US, RSc, AJ, BM, PTM, SVC, FH, and CPa. The Imaging Genetics in Psychosis study was funded by Project Grants from the NHMRC (Grant Nos. APP630471 and APP1081603 [to YQ]) and the Macquarie University’s Australian Research Council (ARC) Centre of Excellence in Cognition and its Disorders (Grant No. CE110001021 [to YQ]). This work was supported by the Spanish Ministry of Science, Innovation and Universities/Economy and Competitiveness/Instituto de Salud Carlos III (Grant Nos. PI11/01766 and CPII19/00009 [to JR]), co-financed by European Regional Development Fund funds from the European Commission (“A Way of Making Europe”). ASRB was supported by the NHMRC (Enabling Grant No. 386500), the Pratt Foundation, Ramsay Health Care, the Viertel Charitable Foundation, and the Schizophrenia Research Institute. Chief investigators for ASRB were VC, US, RSc, AJ, BM, PTM, SVC, FH, and CPa. SR was supported by an NHMRC Senior Fellowship (Grant No. GNT1154651). Collection of the COGSBD cohort was funded by the Jack Brockhoff Foundation, University of Melbourne, Barbara Dicker Brain Sciences Foundation, Rebecca L Cooper Foundation, and the Society of Mental Health Research (to SR). This work was supported by NIHR; MRC (to KR), NIH (Grant Nos. MH-094268, MH-105660, and MH-107730 [to ASS]). The Neuroimaging of the Children's Attention Project cohort was funded by NHMRC, Australia (Grant No. 1065895). Earlier funding for the cohort as also provided by NHMRC (Grant No. 1008522) and a grant from the Collier Foundation. The ACPU cohort was funded by NHMRC, Australia (Project Grant Nos. 384419 and 569533 [to TS]). This work was supported by research grants from the National Healthcare Group, Singapore (Grant Nos. SIG/05004, SIG/05028, and SIG /1103), and the Singapore Bioimaging Consortium (RP C009/2006 [to KS]), and the Ministry of Health, Czech Republic - conceptual development of research organization (“Institute for Clinical and Experimental Medicine - IKEM, IN 00023001” [to ASk]). This study was supported by the Italian Ministry of Health (Grant No. RC/17-18-19-20-21/A [to GS]) and Ministry of Health of the Czech Republic (Grant No. NU20-04-00393 [to FS]). The Drakenstein Child Health Study (DCHS) cohort is funded by the Bill and Melinda Gates Foundation (Grant No. OPP 1017641) and the South African Medical Research Council. This DCHS contribution was made possible in part by a grant from Carnegie Corporation of New York. The statements made and views expressed are solely the responsibility of the author (DJS). STRADL study was supported and funded by the Wellcome Trust Strategic Award “Stratifying Resilience and Depression Longitudinally” (Grant No. 104036/Z/14/Z), and the Medical Research Council Mental Health Pathfinder Award “Leveraging routinely collected and linked research data to study the causes and consequences of common mental disorders” (MRC, Grant No. MC_PC_17209). Scottish Bipolar Family Study (SBFS) was supported by National Health Service Research Scotland, through the Scottish Mental Health Research Network (www.smhrn.org.uk), who provided assistance with subject recruitment and assessments. SBFS was conducted at the Brain Research Imaging Centre (http://www.bric.ed.ac.uk), which is supported by SINAPSE (Scottish Imaging Network, a Platform for Scientific Excellence, http://www.sinapse.ac.uk). Processing of the datasets used the resources provided by the Edinburgh Compute and Data Facility (http://www.ecdf.ed.ac.uk/) (ASt). TVR was supported by an NHMRC Early Career Fellowship (Grant No. GNT1088785). Collection of the COGSBD cohort was funded by the Jack Brockhoff Foundation, University of Melbourne, Barbara Dicker Brain Sciences Foundation, Rebecca L Cooper Foundation, and the Society of Mental Health Research (to TVR). EV was supported by the Spanish Ministry of Science and Innovation (PI18/00805) integrated into the Plan Nacional de I+D+I and co-financed by the ISCIII-Subdirección General de Evaluación and the FEDER; the Instituto de Salud Carlos III; the CIBERSAM (Centro de Investigación Biomédica en Red de Salud Mental); by the CERCA Programme/Generalitat de Catalunya and the Secretaria d’Universitats i Recerca del Departament d’Economia I Coneixement (Grant No. 2017SGR1355). This study was also supported by the Departament de Salut de la Generalitat de Catalunya, Pla Estratègic de Recerca i Innovació en Salut (PERIS) 2016-2020 (Grant No. SLT006/17/00345) and the European Union Horizon 2020 research and innovation program (EU.3.1.1. Understanding health, wellbeing and disease: Grant Nos. 754907 and EU.3.1.3 [to EB]; Treating and managing disease: Grant No. 945151 [to EV]). This study was supported by the National Center for Complementary and Integrative Health (Grant Nos. R21AT009173 and R61AT009864 [to TTY]); by the National Center for Advancing Translational Sciences (CTSI), National Institutes of Health, through UCSF-CTSI (Grant No. UL1TR001872 [to TTY]); by the American Foundation for Suicide Prevention (Grant No. SRG-1-141-18 [to TTY]); by UCSF Research Evaluation and Allocation Committee (REAC) and J. Jacobson Fund (to TTY); by the NIMH (Grant No. R01MH085734 [to TTY]); and by the Brain and Behavior Research Foundation (formerly NARSAD) (to TTY). This work was supported by a personal Veni grant to MH from the Netherlands Organization for Scientific Research (NWO, Grant No. 91619115 [to MH]) and European Community’s Horizon 2020 Programme (H2020/2014 – 2020) (Grant Agreements Nos. 667302 [CoCA], 728018 [Eat2beNICE], and 847879 [PRIME] [to BF]). JBu has been supported by the EU-AIMS (European Autism Interventions) and AIMS-2-TRIALS programmes, which receive support from Innovative Medicines Initiative Joint Undertaking Grant Nos. 115300 and 777394, the resources of which are composed of financial contributions from the European Union’s FP7 and Horizon 2020 Programmes, and from the European Federation of Pharmaceutical Industries and Associations companies’ in-kind contributions, and AUTISM SPEAKS, Autistica and SFARI; and by the Horizon 2020–supported programme CANDY (Grant No. 847818 [to JBu]). This work is supported by Grant No. NIA T32AG058507 and NIH Grant No. U54EB020403 from the Big Data to Knowledge (BD2K) Program (to CRKC). ENIGMA MDD work is supported by NIH (Grant Nos. U54 EB020403 [to PT], R01 MH116147 [to PT], and R01 MH117601 [to NJ and LS]). LS was supported by an NHMRC Career Development Fellowship (Grant No. 1140764). This work was supported by the National Center for Research Resources at the NIH (Grant Nos. NIH 1 U24 RR021992 [Function Biomedical Informatics Research Network], NIH 1 U24 RR025736-01 [Biomedical Informatics Research Network Coordinating Center; http://www.birncommunity.org]). TGMvE is supported by ENIGMA’s NIH BD2K initiative (Grant No. U54 EB020403), ENIGMA Sex Differences (Grant No. R01MH116147), and ENIGMA-COINSTAC: Advanced Worldwide Transdiagnostic Analysis of Valence System Brain Circuits (Grant No. R01MH121246). This work was supported by the NIH (Grant No. R01MH121246 [to JT, Calhoun, and TGMvE]). This work was supported in part by NIH (Grant No. U54 EB020403 [to PT]).
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- 2022
21. Assessment of neuropsychological function in brain tumor treatment: a comparison of traditional neuropsychological assessment with app-based cognitive screening
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Rafael Romero-Garcia, Mallory Owen, Alexa McDonald, Emma Woodberry, Moataz Assem, Pedro Coelho, Rob C Morris, Stephen J Price, Tom Santarius, John Suckling, Tom Manly, Yaara Erez, Michael G Hart, Romero-Garcia, Rafael [0000-0002-5199-4573], Apollo - University of Cambridge Repository, Guarantors of Brain, Cancer Research UK, Junta de Andalucía, Royal Society (UK), Cambridge Trust, National Institute for Health Research (UK), National Institute for Health and Care Research (US), Brain Tumour Charity, Price, Stephen [0000-0002-7535-3009], and Suckling, John [0000-0002-5098-1527]
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medicine.medical_specialty ,Population ,Neurosurgery ,Audiology ,Neuropsychological Tests ,Diffuse Glioma ,Cognition ,Neuropsychology ,Memory span ,Medicine ,Humans ,Neuropsychological assessment ,education ,education.field_of_study ,Modalities ,medicine.diagnostic_test ,business.industry ,Brain Neoplasms ,Glioma ,Neuropsychiatry ,Mobile Applications ,Cognitive test ,Quality of Life ,Surgery ,Cognitive function ,Neurology (clinical) ,business ,Cognition Disorders - Abstract
[Background] Gliomas are typically considered to cause relatively few neurological impairments. However, cognitive difficulties can arise, for example during treatment, with potential detrimental effects on quality of life. Accurate, reproducible, and accessible cognitive assessment is therefore vital in understanding the effects of both tumor and treatments. Our aim is to compare traditional neuropsychological assessment with an app-based cognitive screening tool in patients with glioma before and after surgical resection. Our hypotheses were that cognitive impairments would be apparent, even in a young and high functioning cohort, and that app-based cognitive screening would complement traditional neuropsychological assessment., [Methods] Seventeen patients with diffuse gliomas completed a traditional neuropsychological assessment and an app-based touchscreen tablet assessment pre- and post-operatively. The app assessment was also conducted at 3- and 12-month follow-up. Impairment rates, mean performance, and pre- and post-operative changes were compared using standardized Z-scores., [Results] Approximately 2–3 h of traditional assessment indicated an average of 2.88 cognitive impairments per patient, while the 30-min screen indicated 1.18. As might be expected, traditional assessment using multiple items across the difficulty range proved more sensitive than brief screening measures in areas such as memory and attention. However, the capacity of the screening app to capture reaction times enhanced its sensitivity, relative to traditional assessment, in the area of non-verbal function. Where there was overlap between the two assessments, for example digit span tasks, the results were broadly equivalent., [Conclusions] Cognitive impairments were common in this sample and app-based screening complemented traditional neuropsychological assessment. Implications for clinical assessment and follow-up are discussed., RRG is funded by a Guarantors of Brain Post-Doctoral Fellowship award, by a Cancer Research UK Cambridge Centre RG86786 (CRUK grant ref: A25117) grant, and by the EMERGIA Junta de Andalucía program. Y. E. is funded by a Royal Society Dorothy Hodgkin Research Fellowship. M. A. is funded by the Cambridge Trust–Yousef Jameel Scholarship. S. J. P. is supported by the National Institute for Health Career Development Fellowship (CDF-2018-11-ST2-003). This report is an independent research supported by the National Institute of Research (NIHR Career Development Fellowship, Mr. Stephen Price, CDF-2018-11-ST2-003). M. G. H. received an award from The Brain Tumour Charity (ref: RG86218) to fund this work.
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- 2022
22. Impact of priming interval on reactogenicity, peak immunological response and waning after homologous and heterologous COVID-19 vaccine schedules: Exploratory analyses of Com-COV, a randomised control trial
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Shaw, RH, Liu, X, Stuart, ASV, Greenland, M, Aley, PK, Andrews, NJ, Cameron, JC, Charlton, S, Clutterbuck, EA, Collins, AM, Dejnirattisai, W, Dinesh, T, Faust, SN, Ferreira, DM, Finn, A, Green, CA, Hallis, B, Heath, PT, Hill, H, Lambe, T, Lazarus, R, Libri, V, Long, F, Mujadidi, YF, Plested, EL, Morey, ER, Provstgaard-Morys, S, Ramasamy, MN, Ramsay, M, Read, RC, Robinson, H, Screaton, GR, Singh, N, Turner, DPJ, Turner, P, Vichos, J, Walker, LL, White, R, Nguyen-Van-Tam, JS, Snape, MD, Com-COV Study Group, and National Institute for Health and Care Research
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1103 Clinical Sciences ,1117 Public Health and Health Services ,1199 Other Medical and Health Sciences - Abstract
Background: Priming COVID-19 vaccine schedules have been deployed at variable intervals globally, which may influence immune persistence and the relative importance of third-dose ‘booster’ programmes. Here, we report on the impact of 4- versus 12-week priming intervals on reactogenicity and the persistence of immune response up to 6 months following homologous and heterologous priming schedules using BNT162b2 (BNT, tozinameran, Comirnaty, Pfizer/BioNTech) and ChAdOx1 nCoV-19 (ChAd, Vaxzevria, AstraZeneca). Methods: Com-COV is a participant-blinded, randomised immunogenicity trial. Results are reported here for the ‘General’ cohort, in which adults aged over 50 years were randomised to four homologous and heterologous schedules using BNT and ChAd with 4- or 12-week priming intervals. Immunogenicity analyses were on the intention-to-treat population (ITT), without evidence of COVID-19 infection at baseline or for the trial duration, with the purpose of describing the effect of priming interval on humoral and cellular immune response at peak and later timepoints, in addition to the effects on reactogenicity and safety Findings: Between 11th–26th Feb 2021, 730 participants were randomised in the general cohort, with 77-89 per arm in the ITT analysis. At 28-days and 6-months post-second dose, the geometric mean concentration (GMC) of anti-SARS-CoV-2 spike IgG was significantly higher in 12- versus 4-week interval arms for homologous schedules. In heterologous arms, there was only a significant difference between intervals for the BNT/ChAd arm at 28-days. Pseudotyped virus neutralisation titres were significantly higher in all 12-week versus 4-week schedules, 28-days post-second dose, with geometric mean ratios 1.4 (95%CI: 1.1-1.8, BNT/BNT), 1.5 (95%CI: 1.2-1.9, ChAd/BNT), 1.6 (95%CI 1.3-2.1, BNT/ChAd) and2.4 (95%CI: 1.7-3.2, ChAd/ChAd). At 6 months post-second dose, anti-spike IgG GMCs fell to 0.17-0.24 of the 28-day post-second dose value across all eight study arms, with only BNT/BNT displaying a slightly slower decay for the 12-week versus 4-week schedule in the adjusted analysis. The rank order of schedules by humoral response was unaffected by interval with BNT/BNT remaining the most immunogenic by antibody response. T-cell responses were reduced in all 12-week priming intervals versus their 4-week counterparts. 12-week schedules for BNT/BNT and ChAd/BNT schedules were up to 80% less reactogenic than 4-week schedules. Interpretation: These data support flexibility in priming interval in all studied COVID-19 vaccine schedules. Longer priming intervals may result in lower reactogenicity in schedules with BNT as a second-dose and higher humoral immunogenicity in homologous schedules, but overall lower T-cell responses across all schedules. Future vaccines employing these novel platforms may benefit from prolonged-interval schedules. ISRCTN:69254139, EudraCT:2020-005085-33.
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- 2022
23. Brain charts for the human lifespan
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Armin Raznahan, Eric Courchesne, Andrea Parolin Jackowski, Kamen A. Tsvetanov, Cameron T. Ellis, R.C. Gur, Bin Bae J, Park Mtm, Pedro A. Valdes-Sosa, Simon N. Vandekar, Jacob W. Vogel, Juan Zhou, Machteld Marcelis, Kiho Im, Patricia Ellen Grant, Minhui Ouyang, Blesa Cabez M, Michael V. Lombardo, Sarah E. Morgan, James P. Boardman, Adamson C, Calhoun Vd, Delarue M, James H. Cole, Pichet Binette A, Roberto Toro, David H. Rowitch, Nynke A. Groenewold, Kevin M. Anderson, David T.W. Jones, Michael Schöll, Wang Ys, Aiden Corvin, R.E. Gur, Damien A. Fair, Gareth Ball, Herma Lina Schaare, Andrew Zalesky, Evdokia Anagnostou, Michael J. Meaney, Taki Y, Gareth J. Sullivan, Warrier, Petra E. Vértes, Chixiang Chen, Lisa T. Eyler, Wei Liao, Tomáš Paus, Jeremy A. Elman, Phillip McGuire, Hisham Ziauddeen, William S. Kremen, Etienne Vachon-Presseau, E.T. Bullmore, Christophe Tzourio, White, Hammill Cf, Mothersill D, Richard N. Henson, Jiang Qiu, Duncan E. Astle, Fabrice Crivello, Paul C. Fletcher, Chertavian C, Kim K, Jennifer Crosbie, Russell Schachar, Gabriel A. Devenyi, Manfred G. Kitzbichler, Tianye Jia, Trey Hedden, Sang Jae Lee, Ross D. Markello, Silke Kern, Ian M. Goodyer, Keith A. Johnson, Frauke Beyer, Bernard Mazoyer, A. Heinz, Sylvane Desrivières, Rosenberg, Gary Donohoe, Ong Mq, Alexander D. Edwards, Dan J. Stein, Nenad Medic, Zuo Xn, Travis T. Mallard, Peter Fonagy, Lindsay W. Victoria, Ingmar Skoog, Avram J. Holmes, Jason P. Lerch, Jed T. Elison, Jianfu Li, John H. Gilmore, Rosemary Holt, Caitlin K. Rollins, Carol E. Franz, Pedro Mario Pan, Saashi A Bedford, Yang N, Jonathan C Ipser, Richard A. I. Bethlehem, Tuulari Jj, Stolicyn A, Hua Huang, Bratislav Misic, Conor Liston, Ayub M, Lisa Ronan, Yeo Bt, Sophie Adler, Charles J. Lynch, Faith M. Gunning, Konrad Wagstyl, M. Mallar Chakravarty, John Suckling, Theodore D. Satterthwaite, Bharath Holla, Yap Seng Chong, Jinglei Lv, Jakob Seidlitz, Niall J Bourke, Xinlei Qian, Simon Baron-Cohen, Cynthia M. Ortinau, Deirel Paz Linares, Thyreau B, René S. Kahn, Aaron P. Schultz, Vanessa Cropley, Eric Westman, Mitchell Valdés-Sosa, Rik Ossenkoppele, André Zugman, Hasse Karlsson, Sylvia Villeneuve, Katja Heuer, Di Biase Ma, Margaret L. Westwater, Sofie L. Valk, David J. Sharp, Brigitte Landeau, Matthew Borzage, Kirsten A. Donald, Timothy Rittman, Richard Beare, Giovanni Abrahão Salum, Gunter Schumann, Ryuta Kawashima, Romero-Garcia R, John Blangero, Yun Hj, Russel T. Shinohara, Nicolas Crossley, Simon K. Warfield, Karen Pierce, George S. Alexopoulos, Katharine Dunlop, David C. Glahn, Francois Lalonde, Anqi Qiu, Lana Vasung, Gaël Chételat, Lídice Galán-García, Clifford R. Jack, Reisa A. Sperling, Anna Zettergren, Elizabeth Kelley, Arno Villringer, Andrea Mechelli, Benegal, Aaron Alexander-Bloch, Nicholas B. Turk-Browne, van Amelsvoort T, John D. Lewis, Heather C. Whalley, A. V. Witte, Zdenka Pausova, Joel T. Nigg, Heather J. Zar, Raymond J. Dolan, Christopher D. Smyser, Jay N. Giedd, Lena Palaniyappan, Ali Gholipour, Areces-Gonzalez A, Peter B. Jones, Jacqueline Hoare, Oskar Hansson, Linnea Karlsson, C Pantelis, Paly L, Bonnie Auyeung, Jorge Bosch-Bayard, Bethlehem, Richard [0000-0002-0714-0685], White, Simon [0000-0001-8642-7037], Astle, Duncan [0000-0002-7042-5392], Baron-Cohen, Simon [0000-0001-9217-2544], Henson, Rik [0000-0002-0712-2639], Jones, Peter [0000-0002-0387-880X], Kitzbichler, Manfred [0000-0002-4494-0753], Rittman, Timothy [0000-0003-1063-6937], Rowitch, David [0000-0002-0079-0060], Tsvetanov, Kamen A. [0000-0002-3178-6363], Westwater-Wozniak, Margaret [0000-0002-2918-0979], Ziauddeen, Hisham [0000-0003-4044-1719], Apollo - University of Cambridge Repository, British Academy, Autism Research Trust, National Institute of Mental Health (US), UK Research and Innovation, Medical Research Council (UK), National Institute for Health and Care Research (US), Wellcome Trust, University of Cambridge, Cambridge Biomedical Research Centre, University of Cambridge [UK] (CAM), University of Pennsylvania, Yale University [New Haven], Institut des Maladies Neurodégénératives [Bordeaux] (IMN), Université de Bordeaux (UB)-Centre National de la Recherche Scientifique (CNRS), Physiopathologie et imagerie des troubles neurologiques (PhIND), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Génétique humaine et fonctions cognitives - Human Genetics and Cognitive Functions (GHFC (UMR_3571 / U-Pasteur_1)), Institut Pasteur [Paris] (IP)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Child and Adolescent Psychiatry Department [AP- HP Hôpital Robert Debré], AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Département de Neuroscience - Department of Neuroscience, Centre de Recherche Interdisciplinaire / Center for Research and Interdisciplinarity [Paris, France] (CRI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Psychiatrie & Neuropsychologie, RS: MHeNs - R2 - Mental Health, MUMC+: MA Med Staf Spec Psychiatrie (9), Neurology, Amsterdam Neuroscience - Neurodegeneration, 3R-BRAIN, AIBL, Alzheimer’s Disease Neuroimaging Initiative, Alzheimer’s Disease Repository Without Borders Investigators, CALM Team, Cam-CAN, CCNP, COBRE, cVEDA, ENIGMA Developmental Brain Age Working Group, Developing Human Connectome Project, FinnBrain, Harvard Aging Brain Study, IMAGEN, KNE96, The Mayo Clinic Study of Aging, NSPN, POND, The PREVENT-AD Research Group, VETSA, [Bethlehem, R. A. I.] Univ Cambridge, Dept Psychiat, Autism Res Ctr, Cambridge, England, [Auyeung, B.] Univ Cambridge, Dept Psychiat, Autism Res Ctr, Cambridge, England, [Baron-Cohen, S.] Univ Cambridge, Dept Psychiat, Autism Res Ctr, Cambridge, England, [Bedford, S. A.] Univ Cambridge, Dept Psychiat, Autism Res Ctr, Cambridge, England, [Holt, R.] Univ Cambridge, Dept Psychiat, Autism Res Ctr, Cambridge, England, [Lombardo, M. V.] Univ Cambridge, Dept Psychiat, Autism Res Ctr, Cambridge, England, [Bethlehem, R. A. I.] Univ Cambridge, Dept Psychiat, Brain Mapping Unit, Cambridge, England, [Kitzbichler, M. G.] Univ Cambridge, Dept Psychiat, Brain Mapping Unit, Cambridge, England, [Seidlitz, J.] Univ Penn, Dept Psychiat, Philadelphia, PA 19104 USA, [Vogel, J. W.] Univ Penn, Dept Psychiat, Philadelphia, PA 19104 USA, [Gur, R. E.] Univ Penn, Dept Psychiat, Philadelphia, PA 19104 USA, [Gur, R. C.] Univ Penn, Dept Psychiat, Philadelphia, PA 19104 USA, [Jackowski, A. P.] Univ Penn, Dept Psychiat, Philadelphia, PA 19104 USA, [Satterthwaite, T. D.] Univ Penn, Dept Psychiat, Philadelphia, PA 19104 USA, [Alexander-Bloch, A. F.] Univ Penn, Dept Psychiat, Philadelphia, PA 19104 USA, [Seidlitz, J.] Childrens Hosp Philadelphia, Dept Child & Adolescent Psychiat & Behav Sci, Philadelphia, PA 19104 USA, [Alexander-Bloch, A. F.] Childrens Hosp Philadelphia, Dept Child & Adolescent Psychiat & Behav Sci, Philadelphia, PA 19104 USA, [Seidlitz, J.] Childrens Hosp Philadelphia & Penn Med, Lifespan Brain Inst, Philadelphia, PA USA, [Chertavian, C.] Childrens Hosp Philadelphia & Penn Med, Lifespan Brain Inst, Philadelphia, PA USA, [Gur, R. E.] Childrens Hosp Philadelphia & Penn Med, Lifespan Brain Inst, Philadelphia, PA USA, [Gur, R. C.] Childrens Hosp Philadelphia & Penn Med, Lifespan Brain Inst, Philadelphia, PA USA, [Alexander-Bloch, A. F.] Childrens Hosp Philadelphia & Penn Med, Lifespan Brain Inst, Philadelphia, PA USA, [White, S. R.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Goodyer, I. M.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Henson, R. N.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Jones, P. B.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Kitzbichler, M. G.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Medic, N.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Morgan, S. E.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Romero-Garcia, R.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Ronan, L.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Suckling, J.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Vertes, P. E.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Warrier, V.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Westwater, M. L.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Ziauddeen, H.] Univ Cambridge, Dept Psychiat, Cambridge, England, [Bullmore, E. 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E.] Univ Cambridge, MRC Cognit & Brain Sci Unit, Cambridge, England, [Henson, R. N.] Univ Cambridge, MRC Cognit & Brain Sci Unit, Cambridge, England, [Whalley, H. C.] Univ Cambridge, MRC Cognit & Brain Sci Unit, Cambridge, England, [Auyeung, B.] Univ Edinburgh, Sch Philosophy Psychol & Language Sci, Dept Psychol, Edinburgh, Midlothian, Scotland, [Pausova, Z.] Univ Edinburgh, Sch Philosophy Psychol & Language Sci, Dept Psychol, Edinburgh, Midlothian, Scotland, [Ayub, M.] Queens Univ, Dept Psychiat, Ctr Neurosci Studies, Kingston, ON, Canada, [Ayub, M.] UCL, Mental Hlth Neurosci Res Dept, Div Psychiat, London, England, [Bae, J.] Seoul Natl Univ, Bundang Hosp, Dept Neuropsychiat, Seongnam, South Korea, [Ball, G.] Univ Melbourne, Dept Paediat, Melbourne, Vic, Australia, [Baron-Cohen, S.] Cambridgeshire & Peterborough NHS Fdn Trust, Cambridge Lifetime Asperger Syndrome Serv CLASS, Cambridge, England, [Benegal, V.] Natl Inst Mental Hlth & Neurosci NIMHANS, Ctr Addict Med, Bengaluru, India, [Beyer, F.] Max Planck Inst Human Cognit & Brain Sci, Dept Neurol, Leipzig, Germany, [Villringer, A.] Max Planck Inst Human Cognit & Brain Sci, Dept Neurol, Leipzig, Germany, [Witte, A. V.] Max Planck Inst Human Cognit & Brain Sci, Dept Neurol, Leipzig, Germany, [Blangero, J.] Univ Texas Rio Grande Valley, South Texas Diabet & Obes Inst, Dept Human Genet, Edinburg, TX USA, [Blesa Cabez, M.] Univ Edinburgh, MRC Ctr Reprod Hlth, Edinburgh, Midlothian, Scotland, [Boardman, J. P.] Univ Edinburgh, MRC Ctr Reprod Hlth, Edinburgh, Midlothian, Scotland, [Sullivan, G.] Univ Edinburgh, MRC Ctr Reprod Hlth, Edinburgh, Midlothian, Scotland, [Borzage, M.] Univ Southern Calif, Childrens Hosp Los Angeles, Keck Sch Med, Fetal & Neonatal Inst,Div Neonatol,Dept Pediat, Los Angeles, CA 90007 USA, [Bosch-Bayard, J. F.] Montreal Neurol Inst, Ludmer Ctr Neuroinformat & Mental Hlth, McGill Ctr Integrat Neurosci, Montreal, PQ, Canada, [Bosch-Bayard, J. F.] McGill Univ, Montreal, PQ, Canada, [Chakravarty, M. 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A.] Queens Univ, Ctr Neurosci Studies, Dept Psychiat, Kingston, ON, Canada, [Kern, S.] Univ Gothenburg, Neuropsychiat Epidemiol Unit, Dept Psychiat & Neurochem,Sahlgrenska Acad, Ctr Ageing & Hlth AGECAP,Inst Neurosci & Physiol, Gothenburg, Sweden, [Skoog, I.] Univ Gothenburg, Neuropsychiat Epidemiol Unit, Dept Psychiat & Neurochem,Sahlgrenska Acad, Ctr Ageing & Hlth AGECAP,Inst Neurosci & Physiol, Gothenburg, Sweden, [Zettergren, A.] Univ Gothenburg, Neuropsychiat Epidemiol Unit, Dept Psychiat & Neurochem,Sahlgrenska Acad, Ctr Ageing & Hlth AGECAP,Inst Neurosci & Physiol, Gothenburg, Sweden, [Kern, S.] Sahlgrens Univ Hosp, Psychiat Cognit & Old Age Psychiat Clin, Reg Vastra Gotaland, Gothenburg, Sweden, [Skoog, I.] Sahlgrens Univ Hosp, Psychiat Cognit & Old Age Psychiat Clin, Reg Vastra Gotaland, Gothenburg, Sweden, [Kim, K. W.] Seoul Natl Univ, Dept Brain & Cognit Sci, Coll Nat Sci, Seoul, South Korea, [Kim, K. 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E.] Alan Turing Inst, London, England, [Mothersill, D.] Natl Coll Ireland, Sch Business, Dept Psychol, Dublin, Ireland, [Mothersill, D.] Natl Univ Ireland Galway, Sch Psychol, Galway, Ireland, [Mothersill, D.] Natl Univ Ireland Galway, Ctr Neuroimaging & Cognit Genom, Galway, Ireland, [Mothersill, D.] Trinity Coll Dublin, Dept Psychiat, Dublin, Ireland, [Nigg, J.] Oregon Hlth & Sci Univ, Dept Psychiat, Sch Med, Portland, OR 97201 USA, [Ong, M. Q. W.] Natl Univ Singapore, Yong Loo Lin Sch Med, Ctr Sleep & Cognit, Singapore, Singapore, [Qian, X.] Natl Univ Singapore, Yong Loo Lin Sch Med, Ctr Sleep & Cognit, Singapore, Singapore, [Zhou, J. 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D.] Univ Toronto, Dept Nutr Sci, Toronto, ON, Canada, [Paz-Linares, D.] Cuban Neurosci Ctr, Havana, Cuba, [Pichet Binette, A.] McGill Univ, Fac Med, Dept Psychiat, Montreal, PQ, Canada, [Villeneuve, S.] McGill Univ, Fac Med, Dept Psychiat, Montreal, PQ, Canada, [Pichet Binette, A.] Douglas Mental Hlth Univ Inst, Montreal, PQ, Canada, [Villeneuve, S.] Douglas Mental Hlth Univ Inst, Montreal, PQ, Canada, [Qiu, J.] Southwest Univ, Sch Psychol, Chongqing, Peoples R China, [Qiu, A.] Natl Univ Singapore, N1 Inst Hlth, Dept Biomed Engn, Singapore, Singapore, [Rittman, T.] Univ Cambridge, Dept Clin Neurosci, Cambridge, England, [Tsvetanov, K. A.] Univ Cambridge, Dept Clin Neurosci, Cambridge, England, [Rollins, C. K.] Harvard Med Sch, Dept Neurol, Boston, MA 02115 USA, [Rollins, C. K.] Boston Childrens Hosp, Dept Neurol, Boston, MA USA, [Romero-Garcia, R.] Univ Seville, Dpto Fisiol Med & Biofis, Inst Biomed Sevilla IBiS HUVR CSIC, Seville, Spain, [Rosenberg, M. D.] Univ Chicago, Dept Psychol, 5848 S Univ Ave, Chicago, IL 60637 USA, [Rosenberg, M. D.] Univ Chicago, Inst Neurosci, Chicago, IL USA, [Rowitch, D. H.] Univ Cambridge, Dept Paediat, Cambridge, England, [Rowitch, D. H.] Univ Cambridge, Wellcome MRC Cambridge Stem Cell Inst, Cambridge, England, [Salum, G. A.] Univ Fed Rio Grande Sul UFRGS, Hosp Clin Porto Alegre, Dept Psychiat, Porto Alegre, RS, Brazil, [Salum, G. A.] Natl Inst Dev Psychiat INPD, Sao Paulo, Brazil, [Schaare, H. L.] Max Planck Inst Human Cognit & Brain Sci, Otto Hahn Grp Cognit Neurogenet, Leipzig, Germany, [Schaare, H. L.] Res Ctr Juelich, Inst Neurosci & Med INM 7 Brain & Behav, Julich, Germany, [Schultz, A. P.] Massachusetts Gen Hosp, Dept Radiol, Athinoula Martinos Ctr Biomed Imaging, Charlestown, MA USA, [Schumann, G.] Fudan Univ, Inst Sci & Technol Brain Inspired Intelligence, Ctr Populat Neurosci & Stratified Med PONS, Shanghai, Peoples R China, [Schumann, G.] Charite Campus Mitte, Dept Psychiat & Psychotherapy, Charite Mental Hlth, PONS Ctr, Berlin, Germany, [Scholl, M.] Univ Gothenburg, Wallenberg Ctr Mol & Translat Med, Gothenburg, Sweden, [Scholl, M.] Univ Gothenburg, Dept Psychiat & Neurochem, Gothenburg, Sweden, [Scholl, M.] UCL, Queens Sq Inst Neurol, Dementia Res Ctr, London, England, [Sharp, D.] UK Dementia Res Inst, Care Res & Technol Ctr, London, England, [Shinohara, R. T.] Univ Penn, Perelman Sch Med, Dept Radiol, Ctr Biomed Image Comp & Analyt, Philadelphia, PA 19104 USA, [Smyser, C. D.] Washington Univ, Sch Med, Dept Neurol, St Louis, MO 63110 USA, [Smyser, C. D.] Washington Univ, Sch Med, Dept Pediat, St Louis, MO 63110 USA, [Smyser, C. D.] Washington Univ, Sch Med, Dept Radiol, St Louis, MO 63110 USA, [Stein, D. J.] Univ Cape Town, Dept Psychiat, SA MRC Unit Risk & Resilience Mental Disorders, Cape Town, South Africa, [Stein, D. J.] Univ Cape Town, Neurosci Inst, Cape Town, South Africa, [Stolicyn, A.] Univ Edinburgh, Ctr Clin Brain Sci, Div Psychiat, Edinburgh, Midlothian, Scotland, [Whalley, H. C.] Univ Edinburgh, Ctr Clin Brain Sci, Div Psychiat, Edinburgh, Midlothian, Scotland, [Toro, R.] Inst Pasteur, Dept Neurosci, Paris, France, [Traut, N.] Inst Pasteur, Dept Neurosci, Paris, France, [Traut, N.] Univ Paris 05, Ctr Res & Interdisciplinar CRI, Paris, France, [Tsvetanov, K. A.] Univ Cambridge, Dept Psychol, Cambridge, England, [Turk-Browne, N. B.] Yale Univ, Wu Tsai Inst, New Haven, CT USA, [Tuulari, J. J.] Univ Turku, Dept Clin Med, Turku, Finland, [Tuulari, J. J.] Univ Turku, Turku Coll Sci Med & Technol, Turku, Finland, [Tzourio, C.] Univ Bordeaux, Bordeaux Populat Hlth Res Ctr, CHU Bordeaux, U1219,INSERM, Bordeaux, France, [Vachon-Presseau, E.] McGill Univ, Fac Dent Med & Oral Hlth Sci, Montreal, PQ, Canada, [Valdes-Sosa, P. A.] McGill Univ, Alan Edwards Ctr Res Pain AECRP, Montreal, PQ, Canada, [Valk, S. L.] Forschungszentrum Julich, Inst Neurosci & Med 7, Julich, Germany, [Valk, S. L.] Max Planck Inst Human Cognit & Brain Sci, Leipzig, Germany, [van Amelsvoort, T.] Maastricht Univ, Dept Psychiat & Neurosychol, Maastricht, Netherlands, [Vandekar, S. N.] Vanderbilt Univ, Dept Biostat, 221 Kirkland Hall, Nashville, TN 37235 USA, [Villeneuve, S.] Vanderbilt Univ, Med Ctr, Dept Biostat, Nashville, TN USA, [Villringer, A.] Univ Leipzig, Clin Cognit Neurol, Med Ctr, Leipzig, Germany, [Witte, A. V.] Univ Leipzig, Clin Cognit Neurol, Med Ctr, Leipzig, Germany, [Zuo, X. N.] Univ Leipzig, Clin Cognit Neurol, Med Ctr, Leipzig, Germany, [Wang, Y. S.] Beijing Normal Univ, State Key Lab Cognit Neurosci & Learning, Beijing, Peoples R China, [Yang, N.] Beijing Normal Univ, State Key Lab Cognit Neurosci & Learning, Beijing, Peoples R China, [Yeo, B.] Beijing Normal Univ, State Key Lab Cognit Neurosci & Learning, Beijing, Peoples R China, [Zuo, X. N.] Beijing Normal Univ, State Key Lab Cognit Neurosci & Learning, Beijing, Peoples R China, [Wang, Y. S.] Beijing Normal Univ, IDG McGovern Inst Brain Res, Dev Populat Neuroscience Res Ctr, Beijing, Peoples R China, [Yang, N.] Beijing Normal Univ, IDG McGovern Inst Brain Res, Dev Populat Neuroscience Res Ctr, Beijing, Peoples R China, [Zuo, X. N.] Beijing Normal Univ, IDG McGovern Inst Brain Res, Dev Populat Neuroscience Res Ctr, Beijing, Peoples R China, [Wang, Y. S.] Natl Basic Sci Data Ctr, Beijing, Peoples R China, [Yang, N.] Natl Basic Sci Data Ctr, Beijing, Peoples R China, [Zuo, X. N.] Natl Basic Sci Data Ctr, Beijing, Peoples R China, [Wang, Y. S.] Chinese Acad Sci, Res Ctr Lifespan Dev Brain & Mind, Inst Psychol, Beijing, Peoples R China, [Yang, N.] Chinese Acad Sci, Res Ctr Lifespan Dev Brain & Mind, Inst Psychol, Beijing, Peoples R China, [Westman, E.] Karolinska Inst, Ctr Alzheimer Res, Dept Neurobiol Care Sci & Soc, Div Clin Geriatr, Stockholm, Sweden, [Witte, A. V.] Univ Leipzig, CRC 1052 Obes Mech, Fac Med, Leipzig, Germany, [Zhou, J. H.] Natl Univ Singapore, Dept Elect & Comp Engn, Singapore, Singapore, [Yeo, B.] Natl Univ Singapore, Yong Loo Lin Sch Med, Ctr Sleep & Cognit, Singapore, Singapore, [Yeo, B.] Natl Univ Singapore, Yong Loo Lin Sch Med, Ctr Translat MR Res, Singapore, Singapore, [Yeo, B.] Natl Univ Singapore, N1 Inst Hlth, Singapore, Singapore, [Yeo, B.] Natl Univ Singapore, Inst Digital Med, Singapore, Singapore, [Yun, H.] Natl Univ Singapore, Integrat Sci & Engn Programme ISEP, Singapore, Singapore, [Zar, H. J.] Univ Melbourne, Dept Biomed Engn, Melbourne, Vic, Australia, [Zhou, J. H.] Natl Univ Singapore, Yong Loo Lin Sch Med, Ctr Translat Magnet Resonance Res, Singapore, Singapore, [Ziauddeen, H.] Univ Cambridge, Wellcome Trust MRC Inst Metab Sci, Cambridge, England, [Zugman, A.] NIMH, NIH, Bethesda, MD 20892 USA, [Zugman, A.] Escola Paulista Med, Dept Psychiat, Sao Paulo, Brazil, [Zuo, X. N.] Nanning Normal Univ, Sch Educ Sci, Key Lab Brain & Educ, Nanning, Peoples R China, British Academy Postdoctoral fellowship, NIMH, UKRI Medical Research Council, NIHR Cambridge Biomedical Research Centre, NIHR Senior Investigator award, MRC research infrastructure award, Commonwealth Scientific and Industrial Research Organisation (CSIRO), and Ontario Brain Institute
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631/378/2649 ,OpenPain Project ,KNE96 ,Growth ,Psychiatric-disorders ,DISEASE ,3R-BRAIN ,Brain charts ,MRI Brain ,OASIS-3 ,Disease ,CCNP ,631/378/2571 ,UMN BCP ,Multidisciplinary ,medicine.diagnostic_test ,PSYCHIATRIC-DISORDERS ,article ,Brain ,Human brain ,ASSOCIATION ,Magnetic Resonance Imaging ,Harvard Aging Brain Study ,The Mayo Clinic Study of Aging, NSPN ,medicine.anatomical_structure ,GROWTH ,[SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC] ,ddc:500 ,BURDEN ,WHITE-MATTER ,FinnBrain, Harvard Aging Brain Study ,Organization ,Mri ,MRI ,medicine.medical_specialty ,Concurrent validity ,MODELS ,Cam-CAN ,Longevity ,CALM Team ,POND ,Neuroimaging ,Burden ,ORGANIZATION ,AIBL ,The PREVENT-AD Research Group, VETSA ,Cortical thickness ,Association ,Physical medicine and rehabilitation ,FinnBrain ,IMAGEN, KNE96 ,White-matter ,medicine ,Humans ,ASRB ,631/378/1689 ,COBRE ,business.industry ,631/378/2611 ,Brain morphometry ,Neurosciences ,Alzheimer’s Disease Repository Without Borders Investigators ,Magnetic resonance imaging ,Alzheimer’s Disease Neuroimaging Initiative ,Anthropometry ,Body Height ,Brain growth ,Birth ,59/57 ,Normative ,IMAGEN ,ENIGMA Developmental Brain Age working group ,NSPN ,business ,CCNP, 3R-BRAIN ,CORTICAL THICKNESS ,Developing Human Connectome Project, ENIGMA Developmental Brain Age working group ,The PREVENT-AD Research Group, VETSA, Bullmore, E.T - Abstract
Over the past few decades, neuroimaging has become a ubiquitous tool in basic research and clinical studies of the human brain. However, no reference standards currently exist to quantify individual differences in neuroimaging metrics over time, in contrast to growth charts for anthropometric traits such as height and weight1. Here we assemble an interactive open resource to benchmark brain morphology derived from any current or future sample of MRI data ( http://www.brainchart.io/ ). With the goal of basing these reference charts on the largest and most inclusive dataset available, acknowledging limitations due to known biases of MRI studies relative to the diversity of the global population, we aggregated 123,984 MRI scans, across more than 100 primary studies, from 101,457 human participants between 115 days post-conception to 100 years of age. MRI metrics were quantified by centile scores, relative to non-linear trajectories2 of brain structural changes, and rates of change, over the lifespan. Brain charts identified previously unreported neurodevelopmental milestones3, showed high stability of individuals across longitudinal assessments, and demonstrated robustness to technical and methodological differences between primary studies. Centile scores showed increased heritability compared with non-centiled MRI phenotypes, and provided a standardized measure of atypical brain structure that revealed patterns of neuroanatomical variation across neurological and psychiatric disorders. In summary, brain charts are an essential step towards robust quantification of individual variation benchmarked to normative trajectories in multiple, commonly used neuroimaging phenotypes., R.A.I.B. was supported by a British Academy Postdoctoral fellowship and by the Autism Research Trust. J. Seidlitz was supported by NIMH T32MH019112-29 and K08MH120564. S.R.W. was funded by UKRI Medical Research Council MC_UU_00002/2 and was supported by the NIHR Cambridge Biomedical Research Centre (BRC-1215-20014). E.T.B. was supported by an NIHR Senior Investigator award and the Wellcome Trust collaborative award for the Neuroscience in Psychiatry Network. A.F.A.-B. was supported by NIMH K08MH120564. Data were curated and analysed using a computational facility funded by an MRC research infrastructure award (MR/M009041/1) to the School of Clinical Medicine, University of Cambridge and supported by the mental health theme of the NIHR Cambridge Biomedical Research Centre.
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- 2022
24. Surface Lattice Plasmon Resonances by Direct In Situ Substrate Growth of Gold Nanoparticles in Ordered Arrays
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Gail A. Vinnacombe‐Willson, Ylli Conti, Steven J. Jonas, Paul S. Weiss, Agustín Mihi, Leonardo Scarabelli, Ministerio de Ciencia, Innovación y Universidades (España), Consejo Superior de Investigaciones Científicas (España), Fundación 'la Caixa', University of California, National Institute for Health and Care Research (US), Hyundai Hope On Wheels, and National Science Foundation (US)
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In situ growth ,Bottom-up synthesis ,Mechanics of Materials ,Mechanical Engineering ,Lattice plasmon resonance ,Plasmonic arrays ,General Materials Science - Abstract
Precise arrangements of plasmonic nanoparticles on substrates are important for designing optoelectronics, sensors and metamaterials with rational electronic, optical and magnetic properties. Bottom-up synthesis offers unmatched control over morphology and optical response of individual plasmonic building blocks. Usually, the incorporation of nanoparticles made by bottom-up wet chemistry starts from batch synthesis of colloids, which requires time-consuming and hard-to-scale steps like ligand exchange and self-assembly. Herein, an unconventional bottom-up wet-chemical synthetic approach for producing gold nanoparticle ordered arrays is developed. Water-processable hydroxypropyl cellulose stencils facilitate the patterning of a reductant chemical ink on which nanoparticle growth selectively occurs. Arrays exhibiting lattice plasmon resonances in the visible region and near infrared (quality factors of >20) are produced following a rapid synthetic step (, The authors thank Camilla Dore for her advice and contributed expertise on the fabrication of HPC films. The authors extend their gratitude to Jose Mendoza Carreño for his assistance with the optical characterization of the gold nanoparticle arrays. This project had received funding from the Spanish Ministry of Science and Innovation through grants FUNFUTURE (CEX2019-000917-S), (FUNFUTURE, in the framework of the Spanish Severo Ochoa Centre of Excellence program) and PID2019-106860GB-I00 (HIGHN). L.S. and A.M. thank the Spanish National Research Council (CSIC) for funding via the I-LINK 2020 international travel grant, which facilitated international exchange period necessary for completion of this work. L.S. and Y.C. research is supported by the 2020 Post-doctoral Junior Leader-Incoming Fellowship by “la Caixa” Foundation (ID 100010434, fellow-ship code LCF/BQ/PI20/11760028). Y.C. acknowledges the auspices of the UAB material science doctoral program. G.A.V.W. thanks the UCLA graduate division for funding through the University of California Office of the President Dissertation Year Fellowship. S.J.J. acknowledges support from the National Institutes of Health (NIH) Common Fund through a NIH Director's Early Independence Award co-funded by the National Institute of Dental and Craniofacial Research and Office of the Director, NIH Grant DP5OD028181. S.J.J. and G.A.V.W. acknowledge support through a Scholar Award from the Hyundai Hope on Wheels Foundation for Pediatric Cancer Research. P.S.W. thanks the National Science Foundation for support through Grant #CHE-2004238., With funding from the Spanish government through the ‘Severo Ochoa Centre of Excellence’ accreditation (CEX2019-000917-S).
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- 2022
25. Whole-exome sequencing identifies genes associated with Tourette's disorder in multiplex families
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Gary A. Heiman, Samuel Kuperman, Andrea Dietrich, Li Deng, Julie Hagstrøm, Yeting Zhang, Jinchuan Xing, Xiaolong Cao, Lisheng Zhou, Pieter J. Hoekstra, Cara Nasello, Astrid Morer, Jay A. Tischfield, Mohamed Abdulkadir, Blanca Garcia-Delgar, Joshua K. Thackray, Kerstin J. Plessen, Justin Koesterich, Thomas V. Fernandez, Robert A. King, Clinical Cognitive Neuropsychiatry Research Program (CCNP), National Institute of Mental Health (US), Tourette Syndrome Association of New Jersey, National Institute of Environmental Health Sciences (US), Instituto de Salud Carlos III, Junta de Andalucía, Sociedad Andaluza de Neurología, Fundación Alicia Koplowitz, Fundación Mutua Madrileña, Jacques and Gloria Gossweiler Foundation, German Research Foundation, Tourette Association of America, National Institute for Health and Care Research (US), Tourette International Collaborative Genetics Study (TIC Genetics), Brown, L.W., Cao, X., Coffey, B.J., Gilbert, D.L., Hedderly, T., Heyman, I., Huyser, C., Kim, E., Kim, Y.S., Koh, Y.J., Leventhal, B.L., Madruga-Garrido, M., Maras, A., Mir, P., Münchau, A., Roessner, V., Song, D.H., State, M.W., Willsey, A.J., Zinner, S.H., Child Psychiatry, Paediatric Psychosocial Care, and Amsterdam Neuroscience - Cellular & Molecular Mechanisms
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0301 basic medicine ,Candidate gene ,Population ,Cadherin Related Proteins ,Nerve Tissue Proteins ,Biology ,Article ,03 medical and health sciences ,Cellular and Molecular Neuroscience ,0302 clinical medicine ,Neurodevelopmental disorder ,Exome Sequencing ,medicine ,Humans ,Family ,Genetic Predisposition to Disease ,education ,Molecular Biology ,Gene ,Genotyping ,Exome sequencing ,Zinc finger ,Genetics ,education.field_of_study ,Genetic heterogeneity ,Serine Endopeptidases ,medicine.disease ,Pedigree ,Genetic Predisposition to Disease/genetics ,Nerve Tissue Proteins/genetics ,Tourette Syndrome/genetics ,Whole Exome Sequencing ,Psychiatry and Mental health ,030104 developmental biology ,030217 neurology & neurosurgery ,Tourette Syndrome - Abstract
Tourette’s Disorder (TD) is a neurodevelopmental disorder (NDD) that affects about 0.7% of the population and is one of the most heritable NDDs. Nevertheless, because of its polygenic nature and genetic heterogeneity, the genetic etiology of TD is not well understood. In this study, we combined the segregation information in 13 TD multiplex families with high-throughput sequencing and genotyping to identify genes associated with TD. Using whole-exome sequencing and genotyping array data, we identified both small and large genetic variants within the individuals. We then combined multiple types of evidence to prioritize candidate genes for TD, including variant segregation pattern, variant function prediction, candidate gene expression, protein–protein interaction network, candidate genes from previous studies, etc. From the 13 families, 71 strong candidate genes were identified, including both known genes for NDDs and novel genes, such as HtrA Serine Peptidase 3 (HTRA3), Cadherin-Related Family Member 1 (CDHR1), and Zinc Finger DHHC-Type Palmitoyltransferase 17 (ZDHHC17). The candidate genes are enriched in several Gene Ontology categories, such as dynein complex and synaptic membrane. Candidate genes and pathways identified in this study provide biological insight into TD etiology and potential targets for future studies., This study was supported by a grant from the National Institute of Mental Health (R01MH092293 to GAH and JAT) and by a grant from the New Jersey Center for Tourette Syndrome (to GAH and JAT). This study was also supported by grants from the National Institute of Mental Health (K08MH099424 to TVF) and the National Institute for Environmental Health Science (R01 ES021462 for YSK and BLL). PM has received grants from the Instituto de Salud Carlos III (PI10/01674, PI13/01461), the Consejería de Economía, Innovación, Ciencia y Empresa de la Junta de Andalucía (CVI-02526, CTS-7685), the Consejería de Salud y Bienestar Social de la Junta de Andalucía (PI-0741/2010, PI-0437-2012, PI-0471-2013), the Sociedad Andaluza de Neurología, the Fundación Alicia Koplowitz, the Fundación Mutua Madrileña, and the Jaques and Gloria Gossweiler Foundation. AM has received grants from the Fundacion Alicia Koplowitz and belongs to the research group of the Comissionat per Universitats i Recerca del Departmanent d’Innovacio (DIUE) 2009SGR1119. AM has received grants from the Deutsche Forschungsgemeinschaft (DFG: MU 1692/3-1, MU 1692/4-1, and FOR 2698). AJW received a Young Investigator Award from Tourette Association of America. IH declares that all research at Great Ormond Street Hospital NHS Foundation Trust and UCL Great Ormond Street Institute of Child Health is made possible by the NIHR Great Ormond Street Hospital Biomedical Research Centre.
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- 2020
26. Help-seeking and access to care for stroke and heart attack during the COVID-19 pandemic: A qualitative study.
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Weis C, Spiliopoulos G, Ignatowicz A, Conroy S, Mannion R, Lasserson D, and Tarrant C
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In this article we explore how people who experienced a stroke, transient ischaemic attack, or heart attack sought health care during the COVID-19 lockdown periods. Semi-structured interviews were conducted with 27 patients admitted to hospital between March 2020 and May 2021, and one carer who was recruited from cardiac and stroke rehabilitation services in two large acute NHS trusts in England. Drawing on concepts of candidacy, illness and moral work, we discuss how people's sense-making about their symptoms fundamentally shaped both their decisions about seeking help and the impact of COVID-19 on help seeking. Risk perception and interactional ritual chain theory allow further exploration of constructing symbols of national identity in times of crises, managing risk and levels of acceptable risk and critique of ambiguous national messaging over accessing health-care services for people with emergency health-care needs. Our findings have wider implications for supporting access into health care for those with life-threatening conditions under highly publicised strain on the health system, including winter pressure and staff strikes, as well as policymaking and public messaging., (© 2024 The Author(s). Sociology of Health & Illness published by John Wiley & Sons Ltd on behalf of Foundation for the Sociology of Health & Illness.)
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- 2024
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27. The Intersection of Socioeconomic Differences and Sex in the Management and Outcomes of Acute Myocardial Infarction: A Nationwide Cohort Study.
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Weight N, Moledina S, Lawson CA, Van Spall HGC, Wijeysundera HC, Rashid M, Kontopantelis E, and Mamas MA
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Patients with lower socioeconomic status (SES) have poorer outcomes following acute myocardial infarction (AMI) than patients with higher SES; however, how sex modifies socioeconomic differences is unclear. Using the United Kingdom (UK) Myocardial Ischaemia National Audit Project (MINAP) registry, alongside Office of National Statistics (ONS) mortality data, we analyzed 736,420 AMI patients between 2005 and 2018, stratified by Index of Multiple Deprivation (IMD) score Quintiles (most affluent [Q1] to most deprived [Q5]). There was no significant difference in probability of in-hospital mortality in our adjusted model according to sex. The probability of 30-day mortality in our adjusted model was similar between men and women throughout Quintiles, ((Q5; Men 7.6%; 95% CI 7.3-7.8% ( P < .001), Women; 7.0%; 95% CI 6.8-7.3%, P < .001)) ((Q1; Men 7.1%; 95% CI 6.8-7.4%, P < .001, Women; 6.9%; 95% CI 6.6-7.1%, P < .001)). The probability of one-year mortality in our adjusted model was higher in men throughout all Quintiles (Q1; Men 15.0%; 95% CI 14.8-15.6%), P < .001, Women; 14.5%; 95% CI 14.2-14.9%, P < .001) (Q5; Men 16.9%; 95% CI 16.5-17.3%, P < .001, Women; 15.5%; 95% CI 15.1-15.9 by %, P < .001). Overall, female sex did not significantly influence the effect of deprivation on AMI processes of care and outcomes., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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28. Prehabilitation for frail patients undergoing hip and knee replacement in the UK: Joint PREP feasibility study for a randomised controlled trial.
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Khalid T, Ben-Shlomo Y, Bertram W, Culliford L, Henderson EJ, Jepson M, Johnson E, Mitchell A, Palmer S, Evans JT, Whitehouse MR, and Wylde V
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- Humans, Aged, Male, Female, United Kingdom, Aged, 80 and over, Frail Elderly, Exercise Therapy methods, Feasibility Studies, Arthroplasty, Replacement, Hip rehabilitation, Arthroplasty, Replacement, Hip methods, Arthroplasty, Replacement, Knee rehabilitation, Arthroplasty, Replacement, Knee methods, Preoperative Exercise
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Objective: To determine the feasibility of conducting a randomised controlled trial (RCT) to evaluate a prehabilitation programme for frail patients undergoing total hip replacement (THR) or total knee replacement (TKR)., Design: Randomised feasibility study with embedded qualitative work., Setting: Three National Health Service hospitals., Participants: Adults aged ≥65 years, frail and scheduled for primary THR or TKR., Intervention: Appointment with a physiotherapist to individualise a home-based exercise programme. Participants were encouraged to do the home exercises daily for 12 weeks pre-operative and were provided with a daily protein supplement. Participants were supported by six telephone calls over the 12-week intervention period., Outcome Measures: Eligibility and recruitment rates, intervention adherence, data completion rates of patient-reported outcome measures, retention rates and acceptability of the trial and intervention. Qualitative interviews were conducted with participants and non-participants and analysed using thematic analysis., Results: Between December 2022 and August 2023, 411 patients were sent a screening pack. Of the 168 patients who returned a screening questionnaire, 79 were eligible and consented to participate, and 64 were randomised. Of the 33 participants randomised to the intervention, 26 attended the intervention appointment. Eighteen participants (69%) received all six intervention follow-up telephone calls. Nineteen participants (73%) completed an intervention adherence log; 13 (68%) adhered to the exercise programme and 11 (58%) adhered to the protein supplementation. The overall retention rate was 86% (55/64 overall) at 12 weeks. The 12-week follow-up questionnaire was returned by 46 of the 55 participants (84%) who were sent a questionnaire. Interviews with 19 patients found that the trial processes and intervention were generally acceptable, but areas of potential improvements were identified., Conclusions: This study demonstrated that a larger study is possible and has identified improvements to optimise the design of an RCT., Trial Registration Number: ISRCTN11121506., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)
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- 2024
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29. The effectiveness of revaccination with pneumococcal polysaccharide vaccine for preventing pneumococcal disease in older adults in England: A population-based cohort study.
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Doherty K, Bonnett L, Agbla SC, Beveridge NER, Decraene V, Fleming KM, Hungerford D, and French N
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- Humans, Aged, Female, Male, England epidemiology, Cohort Studies, Middle Aged, Aged, 80 and over, Streptococcus pneumoniae immunology, Proportional Hazards Models, Hospitalization statistics & numerical data, Vaccine Efficacy, Pneumococcal Vaccines administration & dosage, Pneumococcal Vaccines immunology, Immunization, Secondary, Pneumococcal Infections prevention & control, Pneumococcal Infections epidemiology
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Background: Pneumococcal disease in older adults in the United Kingdom is rising despite immunisation. A key gap in the literature is the clinical effectiveness of revaccination with the pneumococcal polysaccharide vaccine (PPV23)., Methods: A cohort study was performed in England, using electronic medical records in the Clinical Practice Research Datalink. Individuals aged ≥64 years and vaccinated with PPV23 were included. Rates of hospitalised pneumonia (HP) and invasive pneumococcal disease (IPD) were compared between individuals receiving a single PPV23 dose versus those receiving two doses using multi-level Cox proportional hazards models. Propensity score weighting was performed to minimise the effect of confounding covariates across the comparison groups., Results: Between 2006 and 2019, there were 462 505 eligible participants. Of those, 6747 (1·5 %) received revaccination. Two doses compared to one dose was associated with an increased risk of HP (adjusted Hazard Ratio [aHR] 1·95; 95 %CI 1·74-2·20) and IPD (aHR 1·44; 95 %CI 1·41-1·46). In participants aged 64-74 years PPV23 revaccination was associated with more IPD (aHR 2·02; 95 %CI 1·75-2·33) and HP (aHR 1·46; 95 %CI 1·42-1.49). In those aged ≥75 years PPV23 revaccination was associated with more HP (aHR 1·12; 95 %CI 1·08-1·16) with no statistically significant difference detected in risk of IPD (aHR 1·20; 95 %CI 0·94-1·52)., Conclusions: No clear benefit of PPV23 revaccination was measured in older adults in this observational study. The small proportion of revaccinated subjects limits the strength of the conclusions. Further research evaluating the clinical effectiveness of PPV23 revaccination is required., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: NF and DH are currently in receipt of grant support from Seqirus UK Ltd. for the evaluation of influenza vaccines in the UK. NF and DH have previously received research-initiated and industry-initiated research grant support from GlaxoSmithKline (GSK) Biologicals for evaluation of rotavirus vaccination in the UK. DH has also received grants from GSK, Sanofi Pasteur, and Merck & Co (Kenilworth, New Jersey, USA) for rotavirus strain surveillance. KD, VD, LB, SA, NB and KF have nothing to disclose., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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30. Experiences as a clinical teaching fellow: interviews with clinical teaching fellows in the West Midlands.
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Harris IM, Dennis N, Ward DJ, Sitch AJ, Parry J, and Greenfield S
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- Humans, United Kingdom, Male, Female, Career Choice, Education, Medical, Graduate, COVID-19, Interviews as Topic, Longitudinal Studies, Medical Staff, Hospital education, Medical Staff, Hospital psychology, Teaching, Adult, Education, Medical, Undergraduate, Fellowships and Scholarships
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Background: The majority of junior doctors in the UK do not proceed directly into specialty training after completing mandatory foundation training but instead take a year out of training. A common post undertaken during a year out of training is a clinical teaching fellow (CTF) role which is used to provide undergraduate medical student teaching. There is only a small amount of literature available regarding CTF posts, and very little of this explores experiences or reasons for taking up such as post. An understanding of the reasons why doctors are choosing to work as CTFs and what their experiences are in post will contribute to how the role is further developed and utilised within the NHS. This study aimed to explore the experiences of CTFs employed in the West Midlands at NHS hospital Trusts., Methods: CTFs working in Trusts in the West Midlands region registered as students on the Education for Healthcare Professionals Post Graduate Certificate course at the University of Birmingham in August 2019 and 2020 who were enrolled in a longitudinal study were invited to take part in an individual interview asking about their experiences as CTFs., Results: Nine CTFs participated in an interview. Five main themes were identified which related to their experiences in post and plans for future careers. Participants reported choosing to undertake a CTF role due to wanting a break from clinical work and having previously enjoyed delivering teaching. Positive experiences in post included lifestyle related benefits and self-development opportunities. Challenges identified with the role included the impact of COVID-19 and volume of students., Conclusion: This is the first study to use interview methodology to explore experiences of CTFs, and has provided a valuable insight into the experiences of those in post in the West Midlands region. Understanding why doctors chose this job and what their experiences are could help to further develop and refine the role. To guarantee demands for teaching staff are met those employing CTFs should be aware of reasons why doctors apply for the post and ensure the post remains a desirable option., (© 2024. The Author(s).)
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- 2024
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31. Associations between cuprotosis-related genes and the spectrum of metabolic dysfunction-associated fatty liver disease: An exploratory study.
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Yuan HY, Liu WY, Feng G, Chen SD, Jin XZ, Chen LL, Song ZJ, Li K, Byrne CD, Targher G, Tian N, Li G, Zhang XL, George J, Zhou M, Wang F, and Zheng MH
- Abstract
Aims: To explore the associations between cuprotosis-related genes (CRGs) across different stages of liver disease in metabolic dysfunction-associated fatty liver disease (MAFLD), including hepatocellular carcinoma (HCC)., Materials and Methods: We analysed several bulk RNA sequencing datasets from patients with MAFLD (n = 331) and MAFLD-related HCC (n = 271) and two MAFLD single-cell RNA sequencing datasets. To investigate the associations between CRGs and MAFLD, we performed differential correlation, logistic regression and functional enrichment analyses. We also validated the findings in an independent Wenzhou PERSONS cohort of MAFLD patients (n = 656) used for a genome-wide association study (GWAS)., Results: GLS, GCSH and ATP7B genes showed significant differences across the MAFLD spectrum and were significantly associated with liver fibrosis stages. GLS was closely associated with fibrosis stages in patients with MAFLD and those with MAFLD-related HCC. GLS is predominantly expressed in monocytes and T cells in MAFLD. During the progression of metabolic dysfunction-associated fatty liver to metabolic-associated steatohepatitis, GLS expression in T cells decreased. GWAS revealed that multiple single nucleotide polymorphisms in GLS were associated with clinical indicators of MAFLD., Conclusions: GLS may contribute to liver inflammation and fibrosis in MAFLD mainly through cuprotosis and T-cell activation, promoting the progression of MAFLD to HCC. These findings suggest that cuprotosis may play a role in MAFLD progression, potentially providing new insights into MAFLD pathogenesis., (© 2024 John Wiley & Sons Ltd.)
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- 2024
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32. How does health visiting in the first year of life vary by family characteristics? A longitudinal analysis of administrative data.
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Bunting C, Clery A, McGrath-Lone L, Liu M, Kendall S, Bedford H, Cavallaro F, Saloniki EC, Harron K, and Woodman J
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Background: The health visiting service in UK promotes the health and wellbeing of families with young children and comprises a universal offer (three mandated contacts between birth and 12 months) and additional contacts based on need. We aimed to understand how the level of health visiting support received varies by family characteristics., Methods: Using the Community Services Data Set linked to Hospital Episode Statistics, we identified 52 555 children in 10 local authorities with complete health visiting data for 12 months between April 2016 and March 2020. We analysed variation in health visiting contacts by deprivation, child ethnicity, maternal age, adversity and previous live births., Results: 41 340/52 555 children (79%) received the universal service; 63% received ≥1 additional contact and 25% received ≥3 additional contacts. The likelihood of receiving ≥3 additional contacts was greatest for children whose mothers had a history of hospital admissions relating to mental health, violence, self-harm or substance misuse (adjusted relative risk = 1.55, 95% confidence interval 1.26-1.92)., Conclusions: Most families received health visiting support in addition to the universal service. Policymakers and commissioners should consider how health visiting services can be expanded or targeted more effectively to ensure all families receive the support they need., (© The Author(s) 2024. Published by Oxford University Press on behalf of Faculty of Public Health.)
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- 2024
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33. Individual participant data meta-analysis to examine linear or non-linear treatment-covariate interactions at multiple time-points for a continuous outcome.
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Hattle M, Ensor J, Scandrett K, van Middelkoop M, van der Windt DA, Holden MA, and Riley RD
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Individual participant data (IPD) meta-analysis projects obtain, harmonise, and synthesise original data from multiple studies. Many IPD meta-analyses of randomised trials are initiated to identify treatment effect modifiers at the individual level, thus requiring statistical modelling of interactions between treatment effect and participant-level covariates. Using a two-stage approach, the interaction is estimated in each trial separately and combined in a meta-analysis. In practice, two complications often arise with continuous outcomes: examining non-linear relationships for continuous covariates and dealing with multiple time-points. We propose a two-stage multivariate IPD meta-analysis approach that summarises non-linear treatment-covariate interaction functions at multiple time-points for continuous outcomes. A set-up phase is required to identify a small set of time-points; relevant knot positions for a spline function, at identical locations in each trial; and a common reference group for each covariate. Crucially, the multivariate approach can include participants or trials with missing outcomes at some time-points. In the first stage, restricted cubic spline functions are fitted and their interaction with each discrete time-point is estimated in each trial separately. In the second stage, the parameter estimates defining these multiple interaction functions are jointly synthesised in a multivariate random-effects meta-analysis model accounting for within-trial and across-trial correlation. These meta-analysis estimates define the summary non-linear interactions at each time-point, which can be displayed graphically alongside confidence intervals. The approach is illustrated using an IPD meta-analysis examining effect modifiers for exercise interventions in osteoarthritis, which shows evidence of non-linear relationships and small gains in precision by analysing all time-points jointly., (© 2024 The Author(s). Research Synthesis Methods published by John Wiley & Sons Ltd.)
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- 2024
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34. GPs' views of prescribing beta- blockers for people with anxiety disorders: a qualitative study.
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Archer C, Kessler D, Wiles N, Chew-Graham CA, and Turner K
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Background: Between 2003 and 2018, incident prescriptions of beta-blockers for anxiety increased substantially, particularly for young adults. National Institute for Health and Care Excellence guidance for anxiety does not recommend beta-blockers, probably due to a lack of evidence to support such use. Recent reports have highlighted the potential risks of beta-blockers., Aim: To understand when and why GPs prescribe beta-blockers for people with anxiety., Design and Setting: In-depth interviews with 17 GPs in Bristol and the surrounding areas., Method: Interviews were held by telephone or video call. A topic guide was used to ensure consistency across interviews. Interviews were audio-recorded, transcribed verbatim, and analysed thematically., Results: Many GPs viewed beta-blockers as 'low risk', particularly for young adults. Some GPs viewed beta-blockers as an alternative to benzodiazepines, acting quickly and not leading to dependence. GPs reflected that some patients appeared to want an 'immediate fix' to their symptoms, which GPs thought beta-blockers could potentially offer. This is salient in light of substantial waiting lists for talking therapies and delays in antidepressants taking effect. GPs described how some patients seemed more willing to try beta-blockers than antidepressants, as patients did not perceive them as 'mental health drugs' and therefore viewed them as potentially more acceptable and less stigmatising. Further, GPs viewed beta-blockers as 'patient-led', with patients managing their own dose and frequency, without GP input., Conclusion: Many GPs believe that beta-blockers have a role to play in the management of anxiety. Given recent increases in the prescribing of these drugs in primary care, there is a need to assess their safety and effectiveness as a treatment for people with anxiety disorders., (© The Authors.)
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- 2024
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35. Machine-learning clustering analysis identifies novel phenogroups in patients with ST-elevation acute myocardial infarction.
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Matetic A, Kyriacou T, and Mamas MA
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- Humans, Male, Female, Cluster Analysis, Middle Aged, Aged, Prognosis, Hospital Mortality trends, Adult, Risk Factors, ST Elevation Myocardial Infarction diagnosis, ST Elevation Myocardial Infarction epidemiology, Machine Learning
- Abstract
Background: Machine learning clustering of patients with ST-elevation acute myocardial infarction (STEMI) may provide important insights into their risk profile, management and prognosis., Methods: All adult discharges for STEMI in the National Inpatient Sample (October 2015 to December 2019) were included, excluding patients with prior myocardial infarction. Machine-learning clustering analysis was used to define clusters based on 21 clinical attributes of interest. Main outcomes of the study were cluster-based comparison of risk profile, in-hospital clinical outcomes and utilization of invasive management. Binomial hierarchical multivariable logistic regression with adjusted odds ratios (aOR) and 95% confidence intervals (95% CI) was used to detect the between-cluster differences., Results: Out of overall 470,960 STEMI cases, the machine-learning analysis revealed 4 different clusters with 205,640 (cluster 0: 'behavioural risk cluster'), 146,400 (cluster 1: 'least comorbidity cluster'), 45,100 (cluster 2: 'diabetes with end-organ damage cluster') and 73,820 (cluster 3: 'cardiometabolic cluster') cases. Attributes with the highest importance for clustering were hypertension and diabetes. After multivariable adjustment, patients from 'diabetes with end-organ damage cluster' exhibited the worst mortality, MACCE and ischemic stroke (p < 0.001 for all), as well as the lowest utilization of invasive management (p < 0.001 for all), in comparison to other clusters. Patients from 'behavioural risk cluster' exhibited the best in-hospital prognosis and the highest utilization of invasive management, compared to other clusters (p < 0.001 for all)., Conclusions: Machine learning driven clustering of inpatients with STEMI reveals important population subgroups with distinct prevalence, risk profile, prognosis and management. Data driven approaches may identify high risk phenogroups and warrants further study., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier B.V. All rights reserved.)
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- 2024
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36. The European Health Data Space can be a boost for research beyond borders.
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Ganna A, Carracedo A, Christiansen CF, Di Angelantonio E, Dykstra PA, Dzhambov AM, Eils R, Green S, Schneider KL, Varga TV, Vuorinen AL, Zuccolo L, Rod NH, and Hoeyer K
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- 2024
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37. Fetal therapies - (Stem cell transplantation; enzyme replacement therapy; in utero genetic therapies).
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Sagar R and David AL
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Advances in ultrasound and prenatal diagnosis are leading an expansion in the options for parents whose fetus is identified with a congenital disease. Obstetric diseases such as pre-eclampsia and fetal growth restriction may also be amenable to intervention to improve maternal and neonatal outcomes. Advanced Medicinal Therapeutic Products such as stem cell, gene, enzyme and protein therapies are most commonly being investigated as the trajectory of treatment for severe genetic diseases moves toward earlier intervention. Theoretical benefits include prevention of in utero damage, smaller treatment doses compared to postnatal intervention, use of fetal circulatory shunts and induction of immune tolerance. New systematic terminology can capture adverse maternal and fetal adverse events to improve safe trial conduct. First-in-human clinical trials are now beginning to generate results with a focus on safety first and efficacy second. If successful, these trials will transform the care of fetuses with severe early-onset congenital disease., Competing Interests: Declaration of competing interest ALD is paid as a consultant by Pierre Fabre Medicamente to be the chair of a Data Safety Monitoring Committee for their “Edelife” first in human clinical trial of intraamniotic protein therapy for a congenital skin disease. https://edelifeclinicaltrial.com/ RS has no conflicts of interest to declare., (Copyright © 2024. Published by Elsevier Ltd.)
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- 2024
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38. The role of dietary modification in the prevention and management of metabolic dysfunction-associated fatty liver disease: An international multidisciplinary expert consensus.
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Zeng XF, Varady KA, Wang XD, Targher G, Byrne CD, Tayyem R, Latella G, Bergheim I, Valenzuela R, George J, Newberry C, Zheng JS, George ES, Spearman CW, Kontogianni MD, Ristic-Medic D, Peres WAF, Depboylu GY, Yang W, Chen X, Rosqvist F, Mantzoros CS, Valenti L, Yki-Järvinen H, Mosca A, Sookoian S, Misra A, Yilmaz Y, Kim W, Fouad Y, Sebastiani G, Wong VW, Åberg F, Wong YJ, Zhang P, Bermúdez-Silva FJ, Ni Y, Lupsor-Platon M, Chan WK, Méndez-Sánchez N, de Knegt RJ, Alam S, Treeprasertsuk S, Wang L, Du M, Zhang T, Yu ML, Zhang H, Qi X, Liu X, Pinyopornpanish K, Fan YC, Niu K, Jimenez-Chillaron JC, and Zheng MH
- Abstract
Metabolic dysfunction-associated fatty liver disease (MAFLD) or metabolic dysfunction-associated steatotic liver disease (MASLD), has become the leading cause of chronic liver disease worldwide. Optimal dietary intervention strategies for MAFLD are not standardized. This study aimed to achieve consensus on prevention of MAFLD through dietary modification. A multidisciplinary panel of 55 international experts, including specialists in hepatology, gastroenterology, dietetics, endocrinology and other medical specialties from six continents collaborated in a Delphi-based consensus development process. The consensus statements covered aspects ranging from epidemiology to mechanisms, management, and dietary recommendations for MAFLD. The recommended dietary strategies emphasize adherence to a balanced diet with controlled energy intake and personalized nutritional interventions, such as calorie restriction, high-protein, or low-carbohydrate diets. Specific dietary advice encouraged increasing the consumption of whole grains, plant-based proteins, fish, seafood, low-fat or fat-free dairy products, liquid plant oils, and deeply colored fruits and vegetables. Concurrently, it advised reducing the intake of red and processed meats, saturated and trans fats, ultra-processed foods, added sugars, and alcohol. Additionally, maintaining the Mediterranean or DASH diet, minimizing sedentary behavior, and engaging in regular physical activity are recommended. These consensus statements lay the foundation for customized dietary guidelines and proposing avenues for further research on nutrition and MAFLD., Competing Interests: Declaration of competing interest Christos S. Mantzoros has recused himself as EIC from handling this manuscript, reports grants through his institution from Merck, Massachusetts Life Sciences Center and Boehringer Ingelheim, has received grants through his Institution and personal consulting fees from Coherus Inc. and AltrixBio, he reports personal consulting fees and support with research reagents from Ansh Inc., collaborative research support from LabCorp Inc., reports personal consulting fees from Olympus, Genfit, Lumos, Novo Nordisk, Amgen, Biodexa, Laekna, Corcept, Intercept, 89 Bio, Madrigal, Aligos, Esperion and Regeneron, travel support and fees from UptoDate, TMIOA, Elsevier, and the Cardio Metabolic Health Conference. Ming-Hua Zheng has received honoraria for lectures from AstraZeneca, Hisky Medical Technologies, and Novo Nordisk and consulting fees from Boehringer Ingelheim and serves as a consultant for Eieling Technology. Christopher D Byrne has received an independent research grant from Echosens. France. W. Kim received honoraria for lectures from GSK, Hanmi, KOBIOLABS, and Novo Nordisk; consulting fees from Boehringer-Ingelheim, GSK, Novo Nordisk, Ildong, YUHAN, Hanmi, HK Inoen, Standigm, PharmaKing, Olix Pharma, TSD Life Sciences, Daewoong, QUEST, Therasid Bioscience, and Korea United Pharm; grants from GSK, Gilead, Novartis, Pfizer, Roche, Springbank, Ildong, BMS, DaeWoong, Hanmi, Novo Nordisk, Galmed, Enyo, and KOBIOLABS; stock options from KOBIOLABS and Lepidyne; and founded Remedygen outside the submitted work. Anoop Misra has received honorarium for lectures from Astra Zendeca, Boehringer Ingelgheim, Janssen, Lupin, Novo Nordisk and US Vitamins. Yusuf Yilmaz has served as a consultant or advisory board member for Zydus and Novo Nordisk. Boehringer Ingelheim. Wah Kheong Chan has served as a consultant or advisory board member for Abbott, Roche, Abbvie, Boehringer Ingelheim and Novo Nordisk; and a speaker for Abbott, Novo Nordisk, Echosens, Viatris and Hisky Medical. Ming-Lung Yu has received research support (grant) from Abbvie, BMS, Gilead, Merck and Roche diagnostics, served as a consultant of Abbott, Abbvie, BMS, Gilead, Roche and Roche diagnostics, and speaker of Abbvie, BMS, Eisai, Gilead, Roche and Roche diagnostics. Vincent Wong has served as a consultant or advisory board member for AbbVie, Boehringer Ingelheim, Echosens, Gilead Sciences, Intercept, Inventiva, Novo Nordisk, Pfizer, Sagimet Biosciences, TARGET PharmaSolutions, and Visirna; and a speaker for Abbott, AbbVie, Echosens, Gilead Sciences, Novo Nordisk, and Unilab. He has received a research grant from Gilead Sciences, and is a co-founder of Illuminatio Medical Technology. Giada Sebastiani has acted as speaker for Merck, Gilead, Abbvie, Novo Nordisk, Pfizer, served as an advisory board member for Pfizer, Merck, Novo Nordisk, Gilead, and has received unrestricted research funding from Theratecnologies Inc. Jacob George has served on advisory Boards and receives honoraria for talks from Novo Nordisk, Astra Zeneca, Roche, BMS, Pfizer, Cincera, Pharmaxis, Boehringer Mannheim, CSL, Gilead, Eisai. Carolyn Newberry serves as a consultant for Nestle Nutrition Sciences. The other authors declare no conflict of interest related to the preparation of this manuscript., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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39. Association between MASLD and increased risk of serious bacterial infections requiring hospital admission: A meta-analysis.
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Mantovani A, Morandin R, Fiorio V, Lando MG, Gaviraghi A, Motta L, Gobbi F, Tilg H, Byrne CD, and Targher G
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Background: Previous studies have reported an association between metabolic dysfunction-associated steatotic liver disease (MASLD) and the risk of serious bacterial infections. However, the magnitude of the risk and whether this risk varies with the severity of MASLD remains uncertain. We performed a meta-analysis of observational studies to quantify the association between MASLD and serious bacterial infections requiring hospital admission., Methods: We systematically searched PubMed, Scopus, Web of Science and Embase from database inception to 1 April 2024, using predefined keywords to identify studies examining the risk of serious bacterial infections among individuals with and without MASLD. MASLD was diagnosed using liver biopsy, imaging or International Classification of Diseases codes. Meta-analysis was performed using random-effects modelling., Results: We identified six cross-sectional and two prospective cohort studies with aggregate data on ~26.6 million individuals. MASLD was significantly associated with higher odds of serious bacterial infections (pooled random-effects odds ratio 1.93, 95% confidence interval [CI] 1.44-2.58; I
2 = 93%). Meta-analysis of prospective cohort studies showed that MAFLD was associated with an increased risk of developing serious bacterial infections (pooled random-effects hazard ratio 1.80, 95% CI 1.62-2.0; I2 = 89%). This risk further increased across the severity of MASLD, especially the severity of fibrosis (pooled random-effects hazard ratio 2.42, 95% CI 1.89-2.29; I2 = 92%). These results remained significant after adjusting for age, sex, obesity, diabetes and other potential confounders. Sensitivity analyses did not modify these findings. The funnel plot did not reveal any significant publication bias., Conclusions: This meta-analysis shows a significant association between MASLD and an increased risk of serious bacterial infections requiring hospital admission., (© 2024 The Author(s). Liver International published by John Wiley & Sons Ltd.)- Published
- 2024
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40. Holistic modelling as a catalyst for effective obesity policy.
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McLaughlin J, Rejon CS, Bell M, Schwander B, Coulman K, and McLeod H
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- Humans, Holistic Health, Obesity prevention & control, Health Policy
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Competing Interests: Competing interests: We have read and understood the BMJ policy on declaration of interests and have the following interests to declare: BS is general manager of the Agency for Health Economic Assessment and Dissemination (AHEAD), which supports the planning, evaluation and implementation of market access and reimbursement strategies for digital health applications, medical devices, and pharmaceuticals in Germany. Provenance and peer review: Not commissioned; externally peer reviewed.
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- 2024
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41. Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic's guide.
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Taher R, Hall CL, Bergin ADG, Gupta N, Heaysman C, Jacobsen P, Kabir T, Kalnad N, Keppens J, Hsu CW, McGuire P, Peters E, Shergill S, Stahl D, Stock BW, and Yiend J
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- Humans, Patient Safety, Research Design, Risk Assessment, Treatment Outcome, Risk Factors, Telemedicine, Mental Health
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Background: The field of digital mental health has followed an exponential growth trajectory in recent years. While the evidence base has increased significantly, its adoption within health and care services has been slowed by several challenges, including a lack of knowledge from researchers regarding how to navigate the pathway for mandatory regulatory approval. This paper details the steps that a team must take to achieve the required approvals to carry out a research study using a novel digital mental health intervention. We used a randomised controlled trial of a digital mental health intervention called STOP (Successful Treatment of Paranoia) as a worked example., Methods: The methods section explains the two main objectives that are required to achieve regulatory approval (MHRA Notification of No Objection) and the detailed steps involved within each, as carried out for the STOP trial. First, the existing safety of digital mental health interventions must be demonstrated. This can refer to literature reviews, any feasibility/pilot safety data, and requires a risk management plan. Second, a detailed plan to further evaluate the safety of the digital mental health intervention is needed. As part of this we describe the STOP study's development of a framework for categorising adverse events and based on this framework, a tool to collect adverse event data., Results: We present literature review results, safety-related feasibility study findings and the full risk management plan for STOP, which addressed 26 possible hazards, and included the 6-point scales developed to quantify the probability and severity of typical risks involved when a psychiatric population receives a digital intervention without the direct support of a therapist. We also present an Adverse Event Category Framework for Digital Therapeutic Devices and the Adverse Events Checklist-which assesses 15 different categories of adverse events-that was constructed from this and used in the STOP trial., Conclusions: The example shared in this paper serves as a guide for academics and professionals working in the field of digital mental health. It provides insights into the safety assessment requirements of regulatory bodies when a clinical investigation of a digital mental health intervention is proposed. Methods, scales and tools that could easily be adapted for use in other similar research are presented, with the expectation that these will assist other researchers in the field seeking regulatory approval for digital mental health products., (© 2024. The Author(s).)
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- 2024
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42. Health outcomes 3 months and 6 months after molnupiravir treatment for COVID-19 for people at higher risk in the community (PANORAMIC): a randomised controlled trial.
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Harris V, Holmes J, Gbinigie-Thompson O, Rahman NM, Richards DB, Hayward G, Dorward J, Lowe DM, Standing JF, Breuer J, Khoo S, Petrou S, Hood K, Ahmed H, Carson-Stevens A, Nguyen-Van-Tam JS, Patel MG, Saville BR, Francis N, Thomas NPB, Evans P, Dobson M, Png ME, Lown M, van Hecke O, Jani BD, Hart ND, Butler D, Cureton L, Patil M, Andersson M, Coates M, Bateman C, Davies JC, Raymundo-Wood I, Ustianowski A, Yu LM, Hobbs FDR, Little P, and Butler CC
- Abstract
Background: No randomised controlled trials have yet reported on the effectiveness of molnupiravir on longer term outcomes for COVID-19. The PANORAMIC trial found molnupiravir reduced time to recovery in acute COVID-19 over 28 days. We aimed to report the effect of molnupiravir treatment for COVID-19 on wellbeing, severe and persistent symptoms, new infections, health care and social service use, medication use, and time off work at 3 months and 6 months post-randomisation., Methods: This study is a follow-up to the main analysis, which was based on the first 28 days of follow-up and has been previously reported. For this multicentre, primary care, open-label, multi-arm, prospective randomised controlled trial conducted in the UK, participants were eligible if aged at least 50 years, or at least 18 years with a comorbidity, and unwell 5 days or less with confirmed COVID-19 in the community. Participants were randomly assigned to the usual care group or molnupiravir group plus usual care (800 mg twice a day for 5 days), which was stratified by age (<50 years or ≥50 years) and vaccination status (at least one dose: yes or no). The primary outcome was hospitalisation or death (or both) at 28 days; all longer term outcomes were considered to be secondary outcomes and included self-reported ratings of wellness (on a scale of 0-10), experiencing any symptom (fever, cough, shortness of breath, fatigue, muscle ache, nausea and vomiting, diarrhoea, loss of smell or taste, headache, dizziness, abdominal pain, and generally feeling unwell) rated as severe (moderately bad or major problem) or persistent, any health and social care use, health-related quality of life (measured by the EQ-5D-5L), time off work or school, new infections, and hospitalisation., Findings: Between Dec 8, 2021, and April 27, 2022, 25 783 participants were randomly assigned to the molnupiravir plus usual care group (n=12 821) or usual care group (n=12 962). Long-term follow-up data were available for 23 008 (89·2%) of 25 784 participants with 11 778 (91·9%) of 12 821 participants in the molnupiravir plus usual care group and 11 230 (86·6%) of 12 963 in the usual care group. 22 806 (99·1%) of 23 008 had at least one previous dose of a SARS-CoV-2 vaccine. Any severe (3 months: adjusted risk difference -1·6% [-2·6% to -0·6%]; probability superiority [p(sup)]>0·99; number needed to treat [NNT] 62·5; 6 months: -1·9% [-2·9% to -0·9%]; p(sup)>0·99, NNT 52·6) or persistent symptoms (3 months: adjusted risk difference -2·1% [-2·9% to -1·5%]; p(sup)>0·99; NNT 47·6; 6 months: -2·5% [-3·3% to -1·6%]; p(sup)>0·99; NNT 40) were reduced in severity, and health-related quality of life (measured by the EQ-5D-5L) improved in the molnupiravir plus usual care group at 3 months and 6 months (3 months: adjusted mean difference 1·08 [0·65 to 1·53]; p(sup)>0·99; 6 months: 1·09 [0·63 to 1·55]; p(sup)>0·99). Ratings of wellness (3 months: adjusted mean difference 0·15 (0·11 to 0·19); p(sup)>0·99; 6 months: 0·12 (0·07 to 0·16); p(sup)>0·99), experiencing any more severe symptom (3 months; adjusted risk difference -1·6% [-2·6% to -0·6%]; p(sup)=0·99; 6 months: -1·9% [-2·9% to -0·9%]; p(sup)>0·99), and health-care use (3 months: adjusted risk difference -1·4% [-2·3% to -0·4%]; p(sup)>0·99; NNT 71·4; 6 months: -0·5% [-1·5% to 0·4%]; p(sup)>0·99; NNT 200) had high probabilities of superiority with molnupiravir treatment. There were significant differences in persistence of any symptom (910 [8·9%] of 10 190 vs 1027 [11%] of 9332, NNT 67) at 6 months, and reported time off work at 3 months (2017 [17·9%] of 11 274 vs 2385 [22·4%] of 10 628) and 6 months (460 [4·4%] of 10 562 vs 527 [5·4%] of 9846; NNT 100). There were no differences in hospitalisations at long-term follow-up., Interpretation: In a vaccinated population, people treated with molnupiravir for acute COVID-19 felt better, experienced fewer and less severe COVID-19 associated symptoms, accessed health care less often, and took less time off work at 6 months. However, the absolute differences in this open-label design are small with high numbers needed to treat., Funding: UK Research and Innovation and National Institute for Health and Care Research., Competing Interests: Declaration of interests JSN-V-T was seconded to the Department of Health and Social Care, England from Oct 1, 2017, to March 31, 2022. On June 15, 2023, JSN-V-T completed one 3-h paid consultancy assignment for Merck Sharp & Dohme on a subject unrelated to COVID-19, and has given two paid lectures for Gilead who have manufactured COVID-19 treatments in 2022–23, and one paid lecture for AstraZeneca in 2022, who manufacture COVID-19 vaccines. JSN-V-T has consulted occasionally for Moderna (May 1, 2023 onwards) who manufacture COVID-19 vaccines. DML has received personal fees from Gilead for an educational video and from Merck for a roundtable discussion, speaker fees from Biotest, Takeda, and Astra Zeneca, and support to attend a conference from Octapharma. DML holds research grants from GlaxoSmithKline and Bristol Myers Squibb, has received consultancy fees from GlaxoSmithKline paid to his institution, all outside the current work, and reports giving lectures for Biotest, Takeda, and AstraZeneca. JFS has participated in a Data and Safety Monitoring Committee for the sotrovimab paediatric programme for GlaxoSmithKline (fee paid to the institution). JB reports being the Principle Investigator on The Medicines and Healthcare products Regulatory Agency commissioned study with GlaxoSmithKline to look at the evolution of variants in sotrovimab treated patients, and consulting fees from GlaxoSmithKline, hVIVO, Moderna, and Symbios (donated to UCL). SK has been a speaker for Pfizer and ViiV Healthcare. KH reports a grant to Cardiff University (via University of Oxford), and was on the National Institute for Health and Care Research (NIHR) Health Technology Assessment General Committee and Health Technology Assessment Funding Strategy Group until November, 2022, and is currently Deputy Chair of the Research Professors panel. BRS reports consulting fees were paid to his former employer (Berry Consultants) for tiral design and implementation. NPBT reports being on a single advisory board in July, 2021, with Merck & Co. OvH reports consulting fees from MindGap. AU reports honoria from Merck & Co, Gilead Sciences, Pfizer, and Astra Zeneca in relation to this disease area and manuscript. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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43. Stop antibiotics when you feel better? Opportunities, challenges and research directions.
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Borek AJ, Ledda A, Pouwels KB, Butler CC, Hayward G, Walker AS, Robotham JV, and Tonkin-Crine S
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Shortening standard antibiotic courses and stopping antibiotics when patients feel better are two ways to reduce exposure to antibiotics in the community, and decrease the risks of antimicrobial resistance and antibiotic side effects. While evidence shows that shorter antibiotic treatments are non-inferior to longer ones for infections that benefit from antibiotics, shorter courses still represent average treatment durations that might be suboptimal for some. In contrast, stopping antibiotics based on improvement or resolution of symptoms might help personalize antibiotic treatment to individual patients and help reduce unnecessary exposure. Yet, many challenges need addressing before we can consider this approach evidence-based and implement it in practice. In this viewpoint article, we set out the main evidence gaps and avenues for future research., (© The Author(s) 2024. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy.)
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- 2024
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44. Research Into Digital Health Intervention for Mental Health: 25-Year Retrospective on the Ethical and Legal Challenges.
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Hall CL, Gómez Bergin AD, and Rennick-Egglestone S
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- Humans, Retrospective Studies, Mental Health Services legislation & jurisprudence, Mental Health Services ethics, Telemedicine ethics, Telemedicine legislation & jurisprudence, Digital Health, Mental Health
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Digital mental health interventions are routinely integrated into mental health services internationally and can contribute to reducing the global mental health treatment gap identified by the World Health Organization. Research teams designing and delivering evaluations frequently invest substantial effort in deliberating on ethical and legal challenges around digital mental health interventions. In this article, we reflect on our own research experience with digital mental health intervention design and evaluation to identify 8 of the most critical challenges that we or others have faced, and that have ethical or legal consequences. These include: (1) harm caused by online recruitment work; (2) monitoring of intervention safety; (3) exclusion of specific demographic or clinical groups; (4) inadequate robustness of effectiveness and cost-effectiveness findings; (5) adequately conceptualizing and supporting engagement and adherence; (6) structural barriers to implementation; (7) data protection and intellectual property; and (8) regulatory ambiguity relating to digital mental health interventions that are medical devices. As we describe these challenges, we have highlighted serious consequences that can or have occurred, such as substantial delays to studies if regulations around Software as a Medical Device (SaMD) are not fully understood, or if regulations change substantially during the study lifecycle. Collectively, the challenges we have identified highlight a substantial body of required knowledge and expertise, either within the team or through access to external experts. Ensuring access to knowledge requires careful planning and adequate financial resources (for example, paying public contributors to engage in debate on critical ethical issues or paying for legal opinions on regulatory issues). Access to such resources can be planned for on a per-study basis and enabled through funding proposals. However, organizations regularly engaged in the development and evaluation of digital mental health interventions should consider creating or supporting structures such as advisory groups that can retain necessary competencies, such as in medical device regulation., (©Charlotte L Hall, Aislinn D Gómez Bergin, Stefan Rennick-Egglestone. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 09.09.2024.)
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- 2024
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45. Is it possible to identify populations experiencing material disadvantage in primary care? A feasibility study using the Clinical Practice Research Database.
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Davies LE, Sinclair DR, Kingston A, Spiers GF, and Hanratty B
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Background: Material disadvantage is associated with poor health, but commonly available area-based metrics provide a poor proxy for it. We investigate if a measure of material disadvantage could be constructed from UK primary care electronic health records., Methods: Using data from Clinical Practice Research Datalink Aurum (May 2022) linked to the 2019 English Index of Multiple Deprivation (IMD), we sought to (1) identify codes that signified material disadvantage, (2) aggregate these codes into a binary measure of material disadvantage and (3) compare the proportion of people with this binary measure against IMD quintiles for validation purposes., Results: We identified 491 codes related to benefits, employment, housing, income, environment, neglect, support services and transport. Participants with one or more of these codes were defined as being materially disadvantaged. Among 30,897,729 research-acceptable patients aged ≥18 with complete data, only 6.1% (n=1,894,225) were classified as disadvantaged using our binary measure, whereas 42.2% (n=13,038,085) belonged to the two most deprived IMD quintiles., Conclusion: Data in a major primary care research database do not currently contain a useful measure of individual-level material disadvantage. This represents an omission of one of the most important health determinants. Consideration should be given to creating codes for use by primary care practitioners., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)
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- 2024
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46. Aging is associated with reduced inflammatory disease activity independent of disease duration in relapsing multiple sclerosis trial populations.
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Coerver EM, Kaçar S, Ciccarelli O, Sormani MP, Barkhof F, Arnold DL, Schoonheim MM, Van Kempen ZL, Mostert J, Koch MW, Killestein J, Eshaghi A, Uitdehaag BM, and Strijbis EM
- Abstract
Background: Higher age is associated with less inflammatory disease activity in relapsing-remitting multiple sclerosis (RRMS). It is unknown whether age itself or disease duration underlies this association., Objectives: This study investigated the effects of age, disease duration, and inflammatory disease activity in people with RRMS., Methods: Individual patient-level data from five large phase III randomized controlled trials (RCTs) was utilized to investigate the association of both age and disease duration with annualized relapse rate (ARR), contrast-enhancing lesions (CELs), and new T2 lesions on magnetic resonance imaging (MRI) at baseline and follow-up., Results: The data set included 5626 participants. Higher age was associated with lower ARRs, lower CEL number on MRI at baseline and follow-up, and lower new T2 lesion numbers at follow-up. This effect was present in all disease duration groups. For example, we found a lower number of new T2 lesions on MRI during follow-up in higher age groups compared to lower age groups, independent of disease duration., Conclusion: Aging in RRMS is associated with a lower risk of inflammatory disease activity, across different disease durations. Age should be taken into account when designing clinical trials and future research should investigate how age should be integrated into personalized predictions of treatment response and risk profiling., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: E.M.E.C. reports no disclosures. S.K. reports no disclosures. O.C. is a member of independent DSMB for Novartis, gave a teaching talk on McDonald criteria in a Merck local symposium, and contributed to an Advisory Board for Biogen; she is Deputy Editor of Neurology, for which she receives an honorarium. M.P.S. received consulting fees from Biogen, Merck, Novartis, Roche, Sanofi, Immunic, Alexion. F.B. serves on the steering committee and is iDMC member for Biogen, Merck, Roche, and EISAI. He acts as a consultant for Roche, Biogen, Merck, IXICO, Jansen, and Combinostics. He has research agreements with Novartis, Merck, Biogen, GE, and Roche. He is co-founder and share holder of Queen Square Analytics Ltd. D.L.A. reports consulting fees from Biogen, Celgene, Frequency Therapeutics, Genentech, Merck, Novartis, Race to Erase MS, Roche, Sanofi-Aventis, Shionogi, and Xfacto Communications; grants from Immunotec and Novartis; and an equity interest in NeuroRx. M.M.S. serves on the editorial board of Neurology, Multiple Sclerosis Journal and Frontiers in Neurology; receives research support from the Dutch MS Research Foundation, Eurostars-EUREKA, ARSEP, Amsterdam Neuroscience, and ZonMW (Vidi grant, project no. 09150172010056); and has served as a consultant for or received research support from Atara Biotherapeutics, Biogen, Celgene/Bristol Meyers Squibb, EIP, Sanofi, MedDay, and Merck. Z.L.E.V.K. reports no disclosures. J.M. reports no disclosures. M.W.K. received consulting fees and travel support from Biogen Idec, Novartis, Roche, Sanofi Genzyme, and EMD Serono. B.M.J.U. has received research support and/or consultancy fees from Biogen Idec, Genzyme, Merck Serono, Novartis, Roche, TEVA, and Immunic Therapeutics. A.E. has received research grants from the Medical Research Council (MRC), National Institute for Health and Care Research (NIHR), Innovate UK, Biogen, Merck, and Roche. He serves as an advisory board member of Merck Serono and Bristol Myers Squib. He is the founder and equity stakeholder in Queen Square Analytics Ltd. He serves on the editorial board of Neurology (American Academy of Neurology). J.K. has accepted speaker and consulting fees from Merck, Biogen, TEVA, Sanofi, Genzyme, Roche, and Novartis. E.M.M.S. has accepted speaker fees from Merck and Novartis.
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- 2024
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47. Bleeding risk prediction after acute myocardial infarction-integrating cancer data: the updated PRECISE-DAPT cancer score.
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Dafaalla M, Costa F, Kontopantelis E, Araya M, Kinnaird T, Micari A, Jia H, Mintz GS, and Mamas MA
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- Humans, Male, Female, Aged, Risk Assessment methods, Middle Aged, ST Elevation Myocardial Infarction epidemiology, United Kingdom epidemiology, Risk Factors, Registries, Platelet Aggregation Inhibitors therapeutic use, Percutaneous Coronary Intervention, Hemorrhage epidemiology, Hemorrhage etiology, Neoplasms complications
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Background and Aims: This study assessed the impact of incorporating cancer as a predictor on performance of the PRECISE-DAPT score., Methods: A nationally linked cohort of ST-elevation myocardial infarction patients between 1 January 2005 and 31 March 2019 was derived from the UK Myocardial Ischaemia National Audit Project and the UK Hospital Episode Statistics Admitted Patient Care registries. The primary outcome was major bleeding at 1 year. A new modified score was generated by adding cancer as a binary variable to the PRECISE-DAPT score using a Cox regression model and compared its performance to the original PRECISE-DAPT score., Results: A total of 216 709 ST-elevation myocardial infarction patients were included, of which 4569 had cancer. The original score showed moderate accuracy (C-statistic .60), and the modified score showed modestly higher discrimination (C-statistics .64; hazard ratio 1.03, 95% confidence interval 1.03-1.04) even in patients without cancer (C-statistics .63; hazard ratio 1.03, 95% confidence interval 1.03-1.04). The net reclassification index was .07. The bleeding rates of the modified score risk categories (high, moderate, low, and very low bleeding risk) were 6.3%, 3.8%, 2.9%, and 2.2%, respectively. According to the original score, 65.5% of cancer patients were classified as high bleeding risk (HBR) and 21.6% were low or very low bleeding risk. According to the modified score, 94.0% of cancer patients were HBR, 6.0% were moderate bleeding risk, and no cancer patient was classified as low or very low bleeding risk., Conclusions: Adding cancer to the PRECISE-DAPT score identifies the majority of patients with cancer as HBR and can improve its discrimination ability without undermining its performance in patients without cancer., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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48. Results from a retrospective case finding and re-engagement exercise for people previously diagnosed with hepatitis C virus to increase uptake of directly acting antiviral treatment.
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Etoori D, Simmons R, Desai M, Foster GR, Stuart A, Sabin C, Mandal S, and Rosenberg W
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- Humans, Male, Female, Middle Aged, Retrospective Studies, Adult, England epidemiology, Hepatitis C drug therapy, Hepatitis C diagnosis, Aged, Patient Acceptance of Health Care statistics & numerical data, Hepacivirus isolation & purification, Antiviral Agents therapeutic use
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Background: Direct acting antivirals (DAAs) for the Hepatitis C virus (HCV) have shifted the World Health Organisation global strategic focus to the elimination of HCV by 2030. In England, the UK Health Security Agency (UKHSA) led a national 'patient re-engagement exercise', using routine surveillance data, which was delivered through the HCV Operational Delivery Networks (ODNs) with support from National Health Service England (NHSE), to help find and support people with a positive HCV PCR test result to access treatment. We report a quantitative evaluation of outcomes of this exercise., Methods: Individuals with a recorded positive HCV antibody or PCR result between 1996 and 2017 were identified using UKHSA's records of HCV laboratory diagnosis. Linkage with established health-care datasets helped to enhance patient identification and minimise attempts to contact deceased or previously treated individuals. From September to November 2018 each ODN was provided with a local list of diagnosed individuals. ODNs were asked to perform further data quality checks through local systems and then write to each individual's GP to inform them that the individual would be contacted by the ODN to offer confirmatory HCV PCR testing, assessment and treatment unless the GP advised otherwise. Outcomes of interest were receipt of treatment, a negative PCR result, and death. Data were collected in 2022., Results: Of 176,555 individuals with a positive HCV laboratory report, 55,329 individuals were included in the exercise following linkage to healthcare datasets and data reconciliation. Participants in the study had a median age of 51 years (IQR: 43, 59), 36,779 (66.5%) were males, 47,668 (86.2%) were diagnosed before 2016 and 11,148 (20.2%) lived in London. Of the study population, 7,442 (13.4%) had evidence of treatment after the re-engagement exercise commenced, 6,435 (11.6%) were reported as PCR negative (96% had no previous treatment records), 4,195 (7.6%) had prescription data indicating treatment before the exercise commenced or were reported to have been treated previously by their ODN, and 2,990 (5.4%) had died. The status of 32,802 (59.3%) people remains unknown., Conclusions: A substantial number of those included had treatment recorded after the exercise commenced, however, many more remain unengaged. Evaluation of the exercise highlighted areas that could be streamlined to improve future exercises., (© 2024. The Author(s).)
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- 2024
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49. Self-supervised learning of wrist-worn daily living accelerometer data improves the automated detection of gait in older adults.
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Brand YE, Kluge F, Palmerini L, Paraschiv-Ionescu A, Becker C, Cereatti A, Maetzler W, Sharrack B, Vereijken B, Yarnall AJ, Rochester L, Del Din S, Muller A, Buchman AS, Hausdorff JM, and Perlman O
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- Humans, Aged, Male, Female, Aged, 80 and over, Activities of Daily Living, Wrist, Algorithms, Wearable Electronic Devices, Middle Aged, Gait physiology, Accelerometry methods, Accelerometry instrumentation, Supervised Machine Learning
- Abstract
Progressive gait impairment is common among aging adults. Remote phenotyping of gait during daily living has the potential to quantify gait alterations and evaluate the effects of interventions that may prevent disability in the aging population. Here, we developed ElderNet, a self-supervised learning model for gait detection from wrist-worn accelerometer data. Validation involved two diverse cohorts, including over 1000 participants without gait labels, as well as 83 participants with labeled data: older adults with Parkinson's disease, proximal femoral fracture, chronic obstructive pulmonary disease, congestive heart failure, and healthy adults. ElderNet presented high accuracy (96.43 ± 2.27), specificity (98.87 ± 2.15), recall (82.32 ± 11.37), precision (86.69 ± 17.61), and F1 score (82.92 ± 13.39). The suggested method yielded superior performance compared to two state-of-the-art gait detection algorithms, with improved accuracy and F1 score (p < 0.05). In an initial evaluation of construct validity, ElderNet identified differences in estimated daily walking durations across cohorts with different clinical characteristics, such as mobility disability (p < 0.001) and parkinsonism (p < 0.001). The proposed self-supervised method has the potential to serve as a valuable tool for remote phenotyping of gait function during daily living in aging adults, even among those with gait impairments., (© 2024. The Author(s).)
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- 2024
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50. A systematic review and meta-analysis of the association between physical capability, social support, loneliness, depression, anxiety, and life satisfaction in older adults.
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Sulandari S, Coats RO, Miller A, Hodkinson A, and Johnson J
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Background and Objectives: Physical capability, social support, loneliness, depression, and anxiety predict life satisfaction in older adults. Currently, no systematic review and meta-analysis has been conducted to investigate the strength of these associations globally. Therefore, this study quantified the strength of these associations., Research Design and Methods: A systematic literature search was conducted using MEDLINE, EMBASE, APA PsycINFO, Web of Science, and Scopus. We included observational studies assessing the association between physical capability, social support, loneliness, depression, and anxiety with life satisfaction in adults aged 65+., Results: 10,552 articles were identified, of which 78 studies in 164,478 participants were included in systematic review and 57 were included in the meta-analysis. Greater life satisfaction was significantly associated with greater physical capabilities (OR=2.64; 95% CI 2.01-3.45; p<0.001, k=35, n=33,732), higher social support (OR=3.27; 95% CI 2.59-4.13, k=20 studies, n=13,228), and reduced loneliness (OR=3.30; 95% CI 2.53-4.30, k=11, n=33,638), depression (OR=4.76; 95% CI 3.10 - 7.32, k=24, n=64,097), and anxiety (OR=5.10; 95% CI 2.21-11.78, k=5, n=43,368). The strength of associations did not vary between Western and Eastern countries, year of publication, or quality. Gender was a moderator: loneliness was more strongly associated with life satisfaction in females. Age was also a moderator, the association between social support and life satisfaction weakened with increasing age., Discussion and Implications: Improving the physical capabilities of older individuals, fostering social support, and alleviating feelings of loneliness, depression, and anxiety may help build life satisfaction in older individuals, which policymakers and healthcare professionals should prioritise when implementing strategies., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Gerontological Society of America.)
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- 2024
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