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SGLT-2 inhibitors and mortality among patients with heart failure with reduced ejection fraction: linked database study BMJ (IF 93.6) Pub Date : 2024-11-06 Henrik Svanström, George Frederick Mkoma, Anders Hviid, Björn Pasternak
Objective To investigate the association between sodium-glucose cotransporter-2 (SGLT-2) inhibitor use and risk of all cause mortality among patients with heart failure with reduced ejection fraction. Design Linked database study. Setting National registers in Denmark, July 2020 to June 2023. Participants Patients with heart failure, aged ≥45 years, with left ventricular ejection fraction ≤40%. Main
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Comparative effectiveness of sodium-glucose cotransporter-2 inhibitors for recurrent nephrolithiasis among patients with pre-existing nephrolithiasis or gout: target trial emulation studies BMJ (IF 93.6) Pub Date : 2024-10-30 Natalie McCormick, Chio Yokose, Na Lu, Deborah J Wexler, J Antonio Aviña-Zubieta, Mary A De Vera, Saiajay Chigurupati, Kiara Tan, Chixiang Chen, Rozalina McCoy, Gary C Curhan, Hyon K Choi
Objective To emulate target trials comparing recurrence of nephrolithiasis among patients with pre-existing nephrolithiasis (overall and stratified by concomitant gout) initiating sodium-glucose cotransporter-2 (SGLT-2) inhibitors versus an active comparator. Design Target trial emulation studies. Setting Canadian population database, January 2014 to June 2022. Participants 20 146 patients with nephrolithiasis
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Malnutrition in infants aged 6-23 months in China’s poorest rural counties from 2016 to 2021: cross sectional study BMJ (IF 93.6) Pub Date : 2024-10-28 Junsheng Huo, Yangmu Huang, Jing Sun, Jian Huang, Jingya Dong, Yinuo Sun, Xing Lin Feng
Objectives To assess trends and differences in child malnutrition by population subgroups among infants aged 6-23 months in China’s poorest rural counties. Design Six consecutive cross sectional surveys were conducted annually. Setting The study was conducted in 116 counties in 19 provinces from 2016 to 2021, representing China’s 832 poorest counties. Participants A total of 210 088 participants were
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Intensive chemotherapy versus standard chemotherapy among patients with high risk, operable, triple negative breast cancer based on integrated mRNA-lncRNA signature (BCTOP-T-A01): randomised, multicentre, phase 3 trial BMJ (IF 93.6) Pub Date : 2024-10-23 Min He, Yi-Zhou Jiang, Yue Gong, Lei Fan, Xi-Yu Liu, Yin Liu, Li-Chen Tang, Miao Mo, Yi-Feng Hou, Gen-Hong Di, Guang-Yu Liu, Ke-Da Yu, Jiong Wu, Xia Yan, Xiao-Hua Zeng, De-Yuan Fu, Chuan-Gui Song, Zhi-Gang Zhuang, Ke-Jin Wu, Jie Wang, Zhong-Hua Wang, Zhi-Ming Shao
Objective To evaluate the feasibility of using a multigene signature to tailor individualised adjuvant therapy for patients with operable triple negative breast cancer. Design Randomised, multicentre, open label, phase 3 trial. Setting 7 cancer centres in China between 3 January 2016 and 17 July 2023. Participants Female patients aged 18-70 years with early triple negative breast cancer after definitive
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Association of holidays and the day of the week with suicide risk: multicounty, two stage, time series study BMJ (IF 93.6) Pub Date : 2024-10-23 Whanhee Lee, Cinoo Kang, Chaerin Park, Michelle L Bell, Ben Armstrong, Dominic Roye, Masahiro Hashizume, Antonio Gasparrini, Aurelio Tobias, Francesco Sera, Yasushi Honda, Aleš Urban, Jan Kyselý, Carmen Íñiguez, Niilo Ryti, Yuming Guo, Shilu Tong, Micheline de Sousa Zanotti Stagliorio Coelho, Eric Lavigne, Francesca de'Donato, Yue Leon Guo, Joel Schwartz, Alexandra Schneider, Susanne Breitner, Yeonseung
Objectives To assess the short term temporal variations in suicide risk related to the day of the week and national holidays in multiple countries. Design Multicountry, two stage, time series design. Setting Data from 740 locations in 26 countries and territories, with overlapping periods between 1971 and 2019, collected from the Multi-city Multi-country Collaborative Research Network database. Participants
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Glucagon-like peptide-1 receptor agonists before upper gastrointestinal endoscopy and risk of pulmonary aspiration or discontinuation of procedure: cohort study BMJ (IF 93.6) Pub Date : 2024-10-22 Wajd Alkabbani, Karine Suissa, Kristine D Gu, Sara J Cromer, Julie M Paik, Katsiaryna Bykov, Ion Hobai, Christopher C Thompson, Deborah J Wexler, Elisabetta Patorno
Objective To assess whether use of glucagon-like peptide-1 (GLP-1) receptor agonists before upper gastrointestinal endoscopy is associated with increased risk of pulmonary aspiration or discontinuation of the procedure compared with sodium-glucose cotransporter-2 (SGLT-2) inhibitors. Design Cohort study. Setting Two deidentified US commercial healthcare databases. Participants 43 365 adults (≥18 years)
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Paternal metformin use and risk of congenital malformations in offspring in Norway and Taiwan: population based, cross national cohort study BMJ (IF 93.6) Pub Date : 2024-10-16 Lin-Chieh Meng, Marleen M H J van Gelder, Hui-Min Chuang, Liang-Kung Chen, Fei-Yuan Hsiao, Hedvig M E Nordeng
Objective To evaluate the association between paternal metformin use and risk of congenital malformations in offspring. Design Population based, cross national cohort study. Setting Norway and Taiwan. Participants 619 389 offspring with paternal data during the period of sperm development (three months before pregnancy) in the Norwegian cohort during 2010-21 and 2 563 812 in the Taiwanese cohort during
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Prioritising primary care patients with unexpected weight loss for cancer investigation: diagnostic accuracy study (update) BMJ (IF 93.6) Pub Date : 2024-10-16 Brian D Nicholson, Pradeep Virdee, Paul Aveyard, Sarah J Price, F D Richard Hobbs, Constantinos Koshiaris, Willie Hamilton
Objective To quantify the predictive value of unexpected weight loss for cancer according to patient’s age, sex, smoking status, and concurrent clinical features (symptoms, signs, and abnormal blood test results). Design Diagnostic accuracy study (update). Setting Data from Clinical Practice Research Datalink electronic health records linked to the National Cancer Registration and Analysis Service
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Intense simplified strategy for newly diagnosed type 2 diabetes in patients with severe hyperglycaemia: multicentre, open label, randomised trial BMJ (IF 93.6) Pub Date : 2024-10-15 Liehua Liu, Weijian Ke, Hai Li, Fangping Li, Guanjie Fan, Jian Kuang, Jianhua Ma, Xiuwei Zhang, Bing Ji, Shu Li, Yinghong Du, Yaoming Xue, Zhaohui Lyu, Leili Gao, Shen Qu, Yongquan Shi, Li Yan, Wanping Deng, Chaoyan Xu, Peiji Dai, Lijuan Xu, Juan Liu, Xuesi Wan, Guohong Wei, Shuang Yu, Shubin Hong, Pengyuan Zhang, Zhimin Huang, Xiaopei Cao, Zhihong Liao, Haipeng Xiao, Yiming Mu, Yehuda Handelsman,
Objective To evaluate whether the intense simplified strategy, which comprises short term intensive insulin therapy (SIIT) followed by subsequent oral antihyperglycaemic regimens, could improve long term glycaemic outcomes in patients with newly diagnosed type 2 diabetes mellitus and severe hyperglycaemia. Design Multicentre, open label, randomised trial. Setting 15 hospitals in China between December
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Progress of nations in the organisation of, and structures for, kidney care delivery between 2019 and 2023: cross sectional survey in 148 countries BMJ (IF 93.6) Pub Date : 2024-10-14 Ikechi G Okpechi, Adeera Levin, Somkanya Tungsanga, Silvia Arruebo, Fergus J Caskey, Innocent I Chukwuonye, Sandrine Damster, Jo-Ann Donner, Udeme E Ekrikpo, Anukul Ghimire, Vivekanand Jha, Valerie Luyckx, Masaomi Nangaku, Syed Saad, Elliot K Tannor, Marcello Tonelli, Feng Ye, Aminu K Bello, David W Johnson
Objective To assess changes in key measures of kidney care using data reported in 2019 and 2023. Design Cross sectional survey in 148 countries. Setting Surveys from International Society of Nephrology Global Kidney Health Atlas between 2019 and 2023 that included participants from countries in Africa (n=36), Eastern and Central Europe (n=16), Latin America (n=18), the Middle East (n=11), Newly Independent
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Rainfall events and daily mortality across 645 global locations: two stage time series analysis BMJ (IF 93.6) Pub Date : 2024-10-09 Cheng He, Susanne Breitner-Busch, Veronika Huber, Kai Chen, Siqi Zhang, Antonio Gasparrini, Michelle Bell, Haidong Kan, Dominic Royé, Ben Armstrong, Joel Schwartz, Francesco Sera, Ana Maria Vicedo-Cabrera, Yasushi Honda, Jouni J K Jaakkola, Niilo Ryti, Jan Kyselý, Yuming Guo, Shilu Tong, Francesca de’Donato, Paola Michelozzi, Micheline de Sousa Zanotti Stagliorio Coelho, Paulo Hilario Nascimento Saldiva
Objective To examine the associations between characteristics of daily rainfall (intensity, duration, and frequency) and all cause, cardiovascular, and respiratory mortality. Design Two stage time series analysis. Setting 645 locations across 34 countries or regions. Population Daily mortality data, comprising a total of 109 954 744 all cause, 31 164 161 cardiovascular, and 11 817 278 respiratory deaths
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Strategies and tactics to reduce the impact of healthcare on climate change: systematic review BMJ (IF 93.6) Pub Date : 2024-10-08 Jeffrey Braithwaite, Carolynn L Smith, Elle Leask, Shalini Wijekulasuriya, Kalissa Brooke-Cowden, Georgia Fisher, Romika Patel, Lisa Pagano, Hania Rahimi-Ardabili, Samantha Spanos, Christina Rojas, Andrew Partington, Ella McQuillan, Genevieve Dammery, Ann Carrigan, Lauren Ehrenfeld, Enrico Coiera, Johanna Westbrook, Yvonne Zurynski
Objective To review the international literature and assess the ways healthcare systems are mitigating and can mitigate their carbon footprint, which is currently estimated to be more than 4.4% of global emissions. Design Systematic review of empirical studies and grey literature to examine how healthcare services and institutions are limiting their greenhouse gas (GHG) emissions. Data sources Eight
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Model of integrated mental health video consultations for people with depression or anxiety in primary care (PROVIDE-C): assessor masked, multicentre, randomised controlled trial BMJ (IF 93.6) Pub Date : 2024-09-25 Markus W Haun, Justus Tönnies, Mechthild Hartmann, Alina Wildenauer, Michel Wensing, Joachim Szecsenyi, Manuel Feißt, Moritz Pohl, Markus Vomhof, Andrea Icks, Hans-Christoph Friederich
Objective To evaluate whether an integrated mental health video consultation approach (PROVIDE model) can improve symptoms compared with usual care in adults with depression and anxiety disorders attending primary care. Design Assessor masked, multicentre, randomised controlled trial (PROVIDE-C). Setting In 29 primary care practices in Germany, working remotely online from one trial hub. Participants
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Heterogeneous effects of Medicaid coverage on cardiovascular risk factors: secondary analysis of randomized controlled trial BMJ (IF 93.6) Pub Date : 2024-09-23 Kosuke Inoue, Susan Athey, Katherine Baicker, Yusuke Tsugawa
Objectives To investigate whether health insurance generated improvements in cardiovascular risk factors (blood pressure and hemoglobin A1c (HbA1c) levels) for identifiable subpopulations, and using machine learning to identify characteristics of people predicted to benefit highly. Design Secondary analysis of randomized controlled trial. Setting Medicaid insurance coverage in 2008 for adults on low
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Comparative effects of drug interventions for the acute management of migraine episodes in adults: systematic review and network meta-analysis BMJ (IF 93.6) Pub Date : 2024-09-18 William K Karlsson, Edoardo G Ostinelli, Zixuan A Zhuang, Lili Kokoti, Rune H Christensen, Haidar M Al-Khazali, Christina I Deligianni, Anneka Tomlinson, Håkan Ashina, Elena Ruiz de la Torre, Hans-Christoph Diener, Andrea Cipriani, Messoud Ashina
Objective To compare all licensed drug interventions as oral monotherapy for the acute treatment of migraine episodes in adults. Design Systematic review and network meta-analysis. Data sources Cochrane Central Register of Controlled Trials, Medline, Embase, ClinicalTrials.gov, EU Clinical Trials Register, WHO International Clinical Trials Registry Platform, as well as websites of regulatory agencies
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The importance of the day of embryo transfer during in vitro fertilisation BMJ (IF 93.6) Pub Date : 2024-09-16 Simone Cornelisse, Liliana Ramos, Sebastiaan Mastenbroek
The timing of embryo transfer, which aligns with different stages of embryo development, is an important element of in vitro fertilisation (IVF). This article briefly describes the main phases of IVF treatment, embryo development and transfer policies, cumulative live birth rates, and the key findings of the authors’ research. In vitro fertilisation (IVF) is a well established treatment for infertility
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Cumulative live birth rate of a blastocyst versus cleavage stage embryo transfer policy during in vitro fertilisation in women with a good prognosis: multicentre randomised controlled trial BMJ (IF 93.6) Pub Date : 2024-09-16 Simone Cornelisse, Kathrin Fleischer, Lucette van der Westerlaken, Jan-Peter de Bruin, Carlijn Vergouw, Carolien Koks, Josien Derhaag, Jantien Visser, Jannie van Echten-Arends, Els Slappendel, Brigitte Arends, Moniek van der Zanden, Angelique van Dongen, Janneke Brink-van der Vlugt, Marcella de Hundt, Max Curfs, Harold Verhoeve, Maaike Traas-Hofmans, Yvonne Wurth, Petra Manger, Quirine Pieterse, Didi
Objectives To evaluate whether embryo transfers at blastocyst stage improve the cumulative live birth rate after oocyte retrieval, including both fresh and frozen-thawed transfers, and whether the risk of obstetric and perinatal complications is increased compared with cleavage stage embryo transfers during in vitro fertilisation (IVF) treatment. Design Multicentre randomised controlled trial. Setting
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Effectiveness of modified vaccinia Ankara-Bavarian Nordic vaccine against mpox infection: emulation of a target trial BMJ (IF 93.6) Pub Date : 2024-09-11 Christine Navarro, Cindy Lau, Sarah A Buchan, Ann N Burchell, Sharifa Nasreen, Lindsay Friedman, Evaezi Okpokoro, Peter C Austin, Darrell H S Tan, Jonathan B Gubbay, Jeffrey C Kwong, Sharmistha Mishra
Objective To estimate the real world effectiveness of modified vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine against mpox infection. Design Emulation of a target trial. Setting Linked databases in Ontario, Canada. Participants 9803 men aged ≥18 years with a history of being tested for syphilis and a laboratory confirmed bacterial sexually transmitted infection (STI) in the previous year, or who
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Effect of laughter exercise versus 0.1% sodium hyaluronic acid on ocular surface discomfort in dry eye disease: non-inferiority randomised controlled trial BMJ (IF 93.6) Pub Date : 2024-09-11 Jing Li, Yinglin Liao, Shi-Yao Zhang, Ling Jin, Nathan Congdon, Zixin Fan, Yangfa Zeng, Yingfeng Zheng, Zuguo Liu, Yizhi Liu, Lingyi Liang
Objective To assess efficacy and safety of laughter exercise in patients with symptomatic dry eye disease. Design Non-inferiority randomised controlled trial. Setting Recruitment was from clinics and community and the trial took place at Zhongshan Ophthalmic Center, Sun Yat-sen University, the largest ophthalmic centre in China, between 18 June 2020 to 8 January 2021. Participants People with symptomatic
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Randomised controlled trials on radiation dose fractionation in breast cancer: systematic review and meta-analysis with emphasis on side effects and cosmesis BMJ (IF 93.6) Pub Date : 2024-09-11 Shing Fung Lee, Samantha K F Kennedy, Saverio Caini, Henry C Y Wong, Pui Lam Yip, Philip M Poortmans, Icro Meattini, Orit Kaidar-Person, Abram Recht, Tarek Hijal, Mylin A Torres, Jeffrey Q Cao, Kimberly S Corbin, J Isabelle Choi, Wee Yao Koh, Jennifer Y Y Kwan, Irene Karam, Adrian W Chan, Edward Chow, Gustavo N Marta
Objective To provide a comprehensive assessment of various fractionation schemes in radiation therapy for breast cancer, with a focus on side effects, cosmesis, quality of life, risks of recurrence, and survival outcomes. Design Systematic review and meta-analysis. Data sources Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (from inception to 23 October 2023). Study selection
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Measures of how well a vaccine works BMJ (IF 93.6) Pub Date : 2024-09-12 Sharmistha Mishra, Christine Navarro, Jeffrey C Kwong
This article discusses definitions of the effect of vaccines across outcomes of interest, from individual level to contacts of vaccinated people to population level. The focus is on the outcome evaluated in an observational study on the effectiveness of mpox vaccine in the context of potential outcomes that could have been measured. When evaluating how well a vaccine works, two categories of outcomes
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Prostate cancer incidence and mortality in Europe and implications for screening activities: population based study BMJ (IF 93.6) Pub Date : 2024-09-04 Salvatore Vaccarella, Mengmeng Li, Freddie Bray, Rune Kvale, Diego Serraino, Valentina Lorenzoni, Anssi Auvinen, Luigino Dal Maso
Objective To provide a baseline comparative assessment of the main epidemiological features of prostate cancer in European populations as background for the proposed EU screening initiatives. Design Population based study. Setting 26 European countries, 19 in the EU, 1980-2017. National or subnational incidence data were extracted from population based cancer registries from the International Agency
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Long term exposure to road traffic noise and air pollution and risk of infertility in men and women: nationwide Danish cohort study BMJ (IF 93.6) Pub Date : 2024-09-04 Mette Sørensen, Aslak Harbo Poulsen, Bugge Nøhr, Jibran Khan, Matthias Ketzel, Jørgen Brandt, Ole Raaschou-Nielsen, Allan Jensen
Objective To investigate associations between long term residential exposure to road traffic noise and particulate matter with a diameter <2.5 µm (PM2.5) and infertility in men and women. Design Nationwide prospective cohort study. Setting Denmark. Participants 526 056 men and 377 850 women aged 30-45 years, with fewer than two children, cohabiting or married, and residing in Denmark between 2000 and
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Developing clinical prediction models: a step-by-step guide BMJ (IF 93.6) Pub Date : 2024-09-03 Orestis Efthimiou, Michael Seo, Konstantina Chalkou, Thomas Debray, Matthias Egger, Georgia Salanti
Predicting future outcomes of patients is essential to clinical practice, with many prediction models published each year. Empirical evidence suggests that published studies often have severe methodological limitations, which undermine their usefulness. This article presents a step-by-step guide to help researchers develop and evaluate a clinical prediction model. The guide covers best practices in
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Risk of dementia after initiation of sodium-glucose cotransporter-2 inhibitors versus dipeptidyl peptidase-4 inhibitors in adults aged 40-69 years with type 2 diabetes: population based cohort study BMJ (IF 93.6) Pub Date : 2024-08-28 Anna Shin, Bo Kyung Koo, Jun Young Lee, Eun Ha Kang
Objective To compare the risk of dementia associated with sodium-glucose cotransporter-2 (SGLT-2) inhibitors versus dipeptidyl peptidase-4 (DPP-4) inhibitors in adults aged 40-69 years with type 2 diabetes. Design Population based cohort study. Setting Korean National Health Insurance Service data, 2013-21. Participants 110 885 propensity score matched pairs of adults with type 2 diabetes aged 40-69
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Comparative oral monotherapy of psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine, ayahuasca, and escitalopram for depressive symptoms: systematic review and Bayesian network meta-analysis BMJ (IF 93.6) Pub Date : 2024-08-21 Tien-Wei Hsu, Chia-Kuang Tsai, Yu-Chen Kao, Trevor Thompson, Andre F Carvalho, Fu-Chi Yang, Ping-Tao Tseng, Chih-Wei Hsu, Chia-Ling Yu, Yu-Kang Tu, Chih-Sung Liang
Objective To evaluate the comparative effectiveness and acceptability of oral monotherapy using psychedelics and escitalopram in patients with depressive symptoms, considering the potential for overestimated effectiveness due to unsuccessful blinding. Design Systematic review and Bayesian network meta-analysis. Data sources Medline, Cochrane Central Register of Controlled Trials, Embase, PsycINFO,
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Suicide rates among physicians compared with the general population in studies from 20 countries: gender stratified systematic review and meta-analysis BMJ (IF 93.6) Pub Date : 2024-08-21 Claudia Zimmermann, Susanne Strohmaier, Harald Herkner, Thomas Niederkrotenthaler, Eva Schernhammer
Objectives To estimate age standardised suicide rate ratios in male and female physicians compared with the general population, and to examine heterogeneity across study results. Design Systematic review and meta-analysis. Data sources Studies published between 1960 and 31 March 2024 were retrieved from Embase, Medline, and PsycINFO. There were no language restrictions. Forward and backwards reference
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Clinical value of guideline recommended molecular targets and genome targeted cancer therapies: cross sectional study BMJ (IF 93.6) Pub Date : 2024-08-20 Ariadna Tibau, Thomas J Hwang, Jerry Avorn, Aaron S Kesselheim
Objective To assess the clinical benefit and actionability of molecular targets for genome targeted cancer drugs recommended for clinical practice by the National Comprehensive Cancer Network (NCCN). Design Cross sectional study. Participants/setting Genome targeted cancer drugs recommended by NCCN guidelines in the advanced setting. Main outcome measures Molecular target actionability was assessed
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Intake of sugar sweetened beverages among children and adolescents in 185 countries between 1990 and 2018: population based study BMJ (IF 93.6) Pub Date : 2024-08-07 Laura Lara-Castor, Renata Micha, Frederick Cudhea, Victoria Miller, Peilin Shi, Jianyi Zhang, Julia R Sharib, Josh Erndt-Marino, Sean B Cash, Simon Barquera, Dariush Mozaffarian
Objective To quantify global intakes of sugar sweetened beverages (SSBs) and trends over time among children and adolescents. Design Population based study. Setting Global Dietary Database. Population Children and adolescents aged 3-19 years in 185 countries between 1990 and 2018, jointly stratified at subnational level by age, sex, parental education, and rural or urban residence. Results In 2018
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Decompression alone or with fusion for degenerative lumbar spondylolisthesis (Nordsten-DS): five year follow-up of a randomised, multicentre, non-inferiority trial BMJ (IF 93.6) Pub Date : 2024-08-07 Eric Loratang Kgomotso, Christian Hellum, Morten Wang Fagerland, Tore Solberg, Jens Ivar Brox, Kjersti Storheim, Erland Hermansen, Eric Franssen, Clemens Weber, Helena Brisby, Knut Robert Hector Algaard, Håvard Furunes, Hasan Banitalebi, Inger Ljøstad, Kari Indrekvam, Ivar Magne Austevoll
Objective To assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis. Design Five year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS). Setting 16 public orthopaedic and neurosurgical clinics in Norway. Participants Patients aged 18-80 years with symptomatic
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Personal protective effect of wearing surgical face masks in public spaces on self-reported respiratory symptoms in adults: pragmatic randomised superiority trial BMJ (IF 93.6) Pub Date : 2024-07-24 Runar Barstad Solberg, Atle Fretheim, Ingeborg Hess Elgersma, Mette Fagernes, Bjørn Gunnar Iversen, Lars G Hemkens, Christopher James Rose, Petter Elstrøm
Objective To evaluate the personal protective effects of wearing versus not wearing surgical face masks in public spaces on self-reported respiratory symptoms over a 14 day period. Design Pragmatic randomised superiority trial. Setting Norway. Participants 4647 adults aged ≥18 years: 2371 were assigned to the intervention arm and 2276 to the control arm. Interventions Participants in the intervention
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Estimating the economic effect of harm associated with high risk prescribing of oral non-steroidal anti-inflammatory drugs in England: population based cohort and economic modelling study BMJ (IF 93.6) Pub Date : 2024-07-24 Elizabeth M Camacho, Leonie S Penner, Amy Taylor, Bruce Guthrie, Anthony J Avery, Darren M Ashcroft, Daniel R Morales, Gabriel Rogers, Antony Chuter, Rachel A Elliott
Objectives To quantify prevalence, harms, and NHS costs in England of problematic oral non-steroidal anti-inflammatory drug (NSAID) prescribing in high risk groups. Design Population based cohort and economic modelling study. Setting Economic models estimating patient harm associated with NSAID specific hazardous prescribing events, and cost to the English NHS, over a 10 year period, were combined
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Intraosseous versus intravenous vascular access in upper extremity among adults with out-of-hospital cardiac arrest: cluster randomised clinical trial (VICTOR trial) BMJ (IF 93.6) Pub Date : 2024-07-23 Ying-Chih Ko, Hao-Yang Lin, Edward Pei-Chuan Huang, An-Fu Lee, Ming-Ju Hsieh, Chih-Wei Yang, Bin-Chou Lee, Yao-Cheng Wang, Wen-Shuo Yang, Yu-Chun Chien, Jen-Tang Sun, Matthew Huei-Ming Ma, Wen-Chu Chiang
Objective To compare the effectiveness of intraosseous versus intravenous vascular access in the treatment of adult patients with out-of-hospital cardiac arrest. Design Cluster randomised controlled trial. Setting The VICTOR (Venous Injection Compared To intraOsseous injection during resuscitation of patients with out-of-hospital cardiac arrest) trial involved emergency medical service agencies with
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Learning implementation of a guideline based decision support system to improve hypertension treatment in primary care in China: pragmatic cluster randomised controlled trial BMJ (IF 93.6) Pub Date : 2024-07-23 Jiali Song, Xiuling Wang, Bin Wang, Yilan Ge, Lei Bi, Fuyu Jing, Huijun Jin, Teng Li, Bo Gu, Lili Wang, Jun Hao, Yanyan Zhao, Jiamin Liu, Haibo Zhang, Xi Li, Jing Li, Wenjun Ma, Jiguang Wang, Sharon-Lise T Normand, Jeph Herrin, Jane Armitage, Harlan M Krumholz, Xin Zheng
Objective To evaluate the effectiveness of a clinical decision support system (CDSS) in improving the use of guideline accordant antihypertensive treatment in primary care settings in China. Design Pragmatic, open label, cluster randomised trial. Setting 94 primary care practices in four urban regions of China between August 2019 and July 2022: Luoyang (central China), Jining (east China), and Shenzhen
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Covid-19 infection and vaccination during first trimester and risk of congenital anomalies: Nordic registry based study BMJ (IF 93.6) Pub Date : 2024-07-17 Maria C Magnus, Jonas Söderling, Anne K Örtqvist, Anne-Marie Nybo Andersen, Olof Stephansson, Siri E Håberg, Stine Kjaer Urhoj
Objectives To evaluate the risk of major congenital anomalies according to infection with or vaccination against covid-19 during the first trimester of pregnancy. Design Prospective Nordic registry based study. Setting Sweden, Denmark, and Norway. Participants 343 066 liveborn singleton infants in Sweden, Denmark, and Norway, with an estimated start of pregnancy between 1 March 2020 and 14 February
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Trends in long term vaping among adults in England, 2013-23: population based study BMJ (IF 93.6) Pub Date : 2024-07-17 Sarah E Jackson, Harry Tattan-Birch, Lion Shahab, Jamie Brown
Objective To examine trends in long term (>6 months) vaping among adults in England. Design Population based study. Setting England. Participants 179 725 adults (≥18 years) surveyed between October 2013 and October 2023. Main outcome measures Time trends in prevalence of long term vaping using logistic regression, overall and by vaping frequency (daily or non-daily), and main type of device used (disposable
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Lee Silverman voice treatment versus NHS speech and language therapy versus control for dysarthria in people with Parkinson’s disease (PD COMM): pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial BMJ (IF 93.6) Pub Date : 2024-07-10 Catherine M Sackley, Caroline Rick, Marian C Brady, Rebecca Woolley, Christopher Burton, Smitaa Patel, Patricia Masterson-Algar, Avril Nicoll, Christina H Smith, Sue Jowett, Natalie Ives, Gillian Beaton, Sylvia Dickson, Ryan Ottridge, Leslie Sharp, Helen Nankervis, Carl E Clarke
Objectives To assess the clinical effectiveness of two speech and language therapy approaches versus no speech and language therapy for dysarthria in people with Parkinson’s disease. Design Pragmatic, UK based, multicentre, three arm, parallel group, unblinded, randomised controlled trial. Setting The speech and language therapy interventions were delivered in outpatient or home settings between 26
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Effectiveness of behavioural interventions with motivational interviewing on physical activity outcomes in adults: systematic review and meta-analysis BMJ (IF 93.6) Pub Date : 2024-07-10 SuFen Zhu, Deepra Sinha, Megan Kirk, Moscho Michalopoulou, Anisa Hajizadeh, Gina Wren, Paul Doody, Lucy Mackillop, Ralph Smith, Susan A Jebb, Nerys M Astbury
Objective To evaluate the effectiveness of behavioural interventions that include motivational interviewing on physical activity outcomes in adults. Design Systematic review and meta-analysis. Study selection A search of seven databases for randomised controlled trials published from inception to 1 March 2023 comparing a behavioural intervention including motivational interviewing with a comparator
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Trends in cardiovascular disease incidence among 22 million people in the UK over 20 years: population based study BMJ (IF 93.6) Pub Date : 2024-06-26 Nathalie Conrad, Geert Molenberghs, Geert Verbeke, Francesco Zaccardi, Claire Lawson, Jocelyn M Friday, Huimin Su, Pardeep S Jhund, Naveed Sattar, Kazem Rahimi, John G Cleland, Kamlesh Khunti, Werner Budts, John J V McMurray
Objective To investigate the incidence of cardiovascular disease (CVD) overall and by age, sex, and socioeconomic status, and its variation over time, in the UK during 2000-19. Design Population based study. Setting UK. Participants 1 650 052 individuals registered with a general practice contributing to Clinical Practice Research Datalink and newly diagnosed with at least one CVD from 1 January 2000
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SGLT-2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors and risk of hyperkalemia among people with type 2 diabetes in clinical practice: population based cohort study BMJ (IF 93.6) Pub Date : 2024-06-26 Edouard L Fu, Deborah J Wexler, Sara J Cromer, Katsiaryna Bykov, Julie M Paik, Elisabetta Patorno
Objectives To evaluate the comparative effectiveness of sodium-glucose cotransporter-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, and dipeptidyl peptidase-4 (DPP-4) inhibitors in preventing hyperkalemia in people with type 2 diabetes in routine clinical practice. Design Population based cohort study with active-comparator, new user design. Setting Claims data from Medicare
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Colchicine in patients with acute ischaemic stroke or transient ischaemic attack (CHANCE-3): multicentre, double blind, randomised, placebo controlled trial BMJ (IF 93.6) Pub Date : 2024-06-26 Jiejie Li, Xia Meng, Fu-Dong Shi, Jing Jing, Hong-Qiu Gu, Aoming Jin, Yong Jiang, Hao Li, S Claiborne Johnston, Graeme J Hankey, J Donald Easton, Liguo Chang, Penglai Shi, Lihua Wang, Xianbo Zhuang, Haitao Li, Yingzhuo Zang, Jianling Zhang, Zengqiang Sun, Dongqi Liu, Ying Li, Hongqin Yang, Jinguo Zhao, Weiran Yu, Anxin Wang, Yuesong Pan, Jinxi Lin, Xuewei Xie, Wei-Na Jin, Shuya Li, Siying Niu, Yilong
Objectives To assess the efficacy and safety of colchicine versus placebo on reducing the risk of subsequent stroke after high risk non-cardioembolic ischaemic stroke or transient ischaemic attack within the first three months of symptom onset (CHANCE-3). Design Multicentre, double blind, randomised, placebo controlled trial. Setting 244 hospitals in China between 11 August 2022 and 13 April 2023.
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Nab-paclitaxel, cisplatin, and capecitabine versus cisplatin and gemcitabine as first line chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma: randomised phase 3 clinical trial BMJ (IF 93.6) Pub Date : 2024-06-19 Guo-Ying Liu, Yan-Fang Ye, Yao-Fei Jiang, Gina Jinna Chen, Wei-Xiong Xia, Yi-Sheng Huang, Tian-Sheng Gao, Yi-Min Liu, Ya-Ting Hou, Jian-Fei Li, Jia-Hao Liu, Nian Lu, Chang-Long Chen, Liang-Ru Ke, Hu Liang, Wei-Xin Bei, Wang-Zhong Li, Shu-Hui Dong, Qin Liu, Changqing Xie, He-Rui Yao, Yan-Qun Xiang
Objective To compare the effectiveness and safety of nab-paclitaxel, cisplatin, and capecitabine (nab-TPC) with gemcitabine and cisplatin as an alternative first line treatment option for recurrent or metastatic nasopharyngeal carcinoma. Design Phase 3, open label, multicentre, randomised trial. Setting Four hospitals located in China between September 2019 and August 2022. Participants Adults (≥18
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Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA): multicentre, open label, randomised controlled trial BMJ (IF 93.6) Pub Date : 2024-06-17 Sandra Bergendahl, Maria Jonsson, Susanne Hesselman, Victoria Ankarcrona, Åsa Leijonhufvud, Anna-Carin Wihlbäck, Tove Wallström, Emmie Rydström, Hanna Friberg, Helena Kopp Kallner, Sophia Brismar Wendel
Objective To assess the effect of lateral episiotomy, compared with no episiotomy, on obstetric anal sphincter injury in nulliparous women requiring vacuum extraction. Design A multicentre, open label, randomised controlled trial. Setting Eight hospitals in Sweden, 2017-23. Participants 717 nulliparous women with a single live fetus of 34 gestational weeks or more, requiring vacuum extraction were
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Global burden of type 1 diabetes in adults aged 65 years and older, 1990-2019: population based study BMJ (IF 93.6) Pub Date : 2024-06-12 Kaijie Yang, Xue Yang, Chenye Jin, Shuangning Ding, Tingting Liu, Bing Ma, Hao Sun, Jing Zhang, Yongze Li
Objectives To estimate the burden, trends, and inequalities of type 1 diabetes mellitus (T1DM) among older adults at global, regional, and national level from 1990 to 2019. Design Population based study. Population Adults aged ≥65 years from 21 regions and 204 countries and territories (Global Burden of Disease and Risk Factors Study 2019) from 1990 to 2019. Main outcome measures Primary outcomes were
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Antiplatelet therapy after coronary artery bypass surgery: five year follow-up of randomised DACAB trial BMJ (IF 93.6) Pub Date : 2024-06-11 Yunpeng Zhu, Wei Zhang, Arnaldo Dimagli, Lin Han, Zhaoyun Cheng, Ju Mei, Xin Chen, Xiaowei Wang, Yanzai Zhou, Qing Xue, Junlong Hu, Min Tang, Rui Wang, Yuanyuan Song, Lei Kang, Bjorn Redfors, Mario Gaudino, Qiang Zhao
Objective To assess the effect of different antiplatelet strategies on clinical outcomes after coronary artery bypass grafting. Design Five year follow-up of randomised Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Grafting (DACAB) trial. Setting Six tertiary hospitals in China; enrolment between July 2014 and November 2015; completion of five year follow-up from August 2019
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Mailed feedback to primary care physicians on antibiotic prescribing for patients aged 65 years and older: pragmatic, factorial randomised controlled trial BMJ (IF 93.6) Pub Date : 2024-06-05 Kevin L Schwartz, Jennifer Shuldiner, Bradley J Langford, Kevin A Brown, Susan E Schultz, Valerie Leung, Nick Daneman, Mina Tadrous, Holly O Witteman, Gary Garber, Jeremy M Grimshaw, Jerome A Leis, Justin Presseau, Michael S Silverman, Monica Taljaard, Tara Gomes, Meagan Lacroix, Jamie Brehaut, Kednapa Thavorn, Sharon Gushue, Lindsay Friedman, Merrick Zwarenstein, Noah Ivers
Objectives To evaluate whether providing family physicians with feedback on their antibiotic prescribing compared with that of their peers reduces antibiotic prescriptions. To also identify effects on antibiotic prescribing from case-mix adjusted feedback reports and messages emphasising antibiotic associated harms. Design Pragmatic, factorial randomised controlled trial. Setting Primary care physicians
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Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial BMJ (IF 93.6) Pub Date : 2024-05-28 Miao-Zhen Qiu, Do-Youn Oh, Ken Kato, Tobias Arkenau, Josep Tabernero, Marcia Cruz Correa, Anastasia V Zimina, Yuxian Bai, Jianhua Shi, Keun-Wook Lee, Jufeng Wang, Elena Poddubskaya, Hongming Pan, Sun Young Rha, Ruixing Zhang, Hidekazu Hirano, David Spigel, Kensei Yamaguchi, Yee Chao, Lucjan Wyrwicz, Umut Disel, Roberto Pazo Cid, Lorenzo Fornaro, Ludovic Evesque, Hongwei Wang, Yaling Xu, Jiang Li, Tao
Objective To evaluate the efficacy and safety of tislelizumab added to chemotherapy as first line (primary) treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma compared with placebo plus chemotherapy. Design Randomised, double blind, placebo controlled, phase 3 study. Setting 146 medical centres across Asia, Europe, and North America, between 13 December 2018 and 28 February
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Association between exposure to antibiotics during pregnancy or early infancy and risk of autism spectrum disorder, intellectual disorder, language disorder, and epilepsy in children: population based cohort study BMJ (IF 93.6) Pub Date : 2024-05-22 Ahhyung Choi, Hyesung Lee, Han Eol Jeong, Seo-Young Lee, Jun Soo Kwon, Jung Yeol Han, Young June Choe, Ju-Young Shin
Objective To evaluate the association between antibiotic use during pregnancy or early infancy and the risk of neurodevelopmental disorders in children. Design Nationwide population based cohort study and sibling analysis. Setting Korea’s National Health Insurance Service mother-child linked database, 2008-21. Participants All children live born between 2009 and 2020, followed up until 2021 to compare
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Epidural analgesia during labour and severe maternal morbidity: population based study BMJ (IF 93.6) Pub Date : 2024-05-22 Rachel J Kearns, Aizhan Kyzayeva, Lucy O E Halliday, Deborah A Lawlor, Martin Shaw, Scott M Nelson
Objectives To determine the effect of labour epidural on severe maternal morbidity (SMM) and to explore whether this effect might be greater in women with a medical indication for epidural analgesia during labour, or with preterm labour. Design Population based study. Setting All NHS hospitals in Scotland. Participants 567 216 women in labour at 24+0 to 42+6 weeks’ gestation between 1 January 2007
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Effect of the HPV vaccination programme on incidence of cervical cancer and grade 3 cervical intraepithelial neoplasia by socioeconomic deprivation in England: population based observational study BMJ (IF 93.6) Pub Date : 2024-05-15 Milena Falcaro, Kate Soldan, Busani Ndlela, Peter Sasieni
Objectives To replicate previous analyses on the effectiveness of the English human papillomavirus (HPV) vaccination programme on incidence of cervical cancer and grade 3 cervical intraepithelial neoplasia (CIN3) using 12 additional months of follow-up, and to investigate effectiveness across levels of socioeconomic deprivation. Design Observational study. Setting England, UK. Participants Women aged
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Clinical and healthcare use outcomes after cessation of long term opioid treatment due to prescriber workforce exit: quasi-experimental difference-in-differences study BMJ (IF 93.6) Pub Date : 2024-05-16 Adrienne H Sabety, Hannah T Neprash, Marema Gaye, Michael L Barnett
Objective To examine the association between prescriber workforce exit, long term opioid treatment discontinuation, and clinical outcomes. Design Quasi-experimental difference-in-differences study Setting 20% sample of US Medicare beneficiaries, 2011-18. Participants People receiving long term opioid treatment whose prescriber stopped providing office based patient care or exited the workforce, as
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Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial BMJ (IF 93.6) Pub Date : 2024-05-15 Kevin G Cooper, Siladitya Bhattacharya, Jane P Daniels, Andrew W Horne, T Justin Clark, Ertan Saridogan, Versha Cheed, Danielle Pirie, Melyda Melyda, Mark Monahan, Tracy E Roberts, Emma Cox, Clive Stubbs, Lee J Middleton
Objectives To evaluate the clinical effectiveness of long acting progestogens compared with the combined oral contraceptive pill in preventing recurrence of endometriosis related pain. Design The PRE-EMPT (preventing recurrence of endometriosis) pragmatic, parallel group, open label, randomised controlled trial. Setting 34 UK hospitals. Participants 405 women of reproductive age undergoing conservative
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Association of ultra-processed food consumption with all cause and cause specific mortality: population based cohort study BMJ (IF 93.6) Pub Date : 2024-05-08 Zhe Fang, Sinara Laurini Rossato, Dong Hang, Neha Khandpur, Kai Wang, Chun-Han Lo, Walter C Willett, Edward L Giovannucci, Mingyang Song
Objective To examine the association of ultra-processed food consumption with all cause mortality and cause specific mortality. Design Population based cohort study. Setting Female registered nurses from 11 US states in the Nurses’ Health Study (1984-2018) and male health professionals from all 50 US states in the Health Professionals Follow-up Study (1986-2018). Participants 74 563 women and 39 501
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Comparative effectiveness of second line oral antidiabetic treatments among people with type 2 diabetes mellitus: emulation of a target trial using routinely collected health data BMJ (IF 93.6) Pub Date : 2024-05-08 Patrick Bidulka, David G Lugo-Palacios, Orlagh Carroll, Stephen O’Neill, Amanda I Adler, Anirban Basu, Richard J Silverwood, Jonathan W Bartlett, Dorothea Nitsch, Paul Charlton, Andrew H Briggs, Liam Smeeth, Ian J Douglas, Kamlesh Khunti, Richard Grieve
Objective To compare the effectiveness of three commonly prescribed oral antidiabetic drugs added to metformin for people with type 2 diabetes mellitus requiring second line treatment in routine clinical practice. Design Cohort study emulating a comparative effectiveness trial (target trial). Setting Linked primary care, hospital, and death data in England, 2015-21. Participants 75 739 adults with
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Efficacy of psilocybin for treating symptoms of depression: systematic review and meta-analysis BMJ (IF 93.6) Pub Date : 2024-05-01 Athina-Marina Metaxa, Mike Clarke
Objective To determine the efficacy of psilocybin as an antidepressant compared with placebo or non-psychoactive drugs. Design Systematic review and meta-analysis. Data sources Five electronic databases of published literature (Cochrane Central Register of Controlled Trials, Medline, Embase, Science Citation Index and Conference Proceedings Citation Index, and PsycInfo) and four databases of unpublished
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Reverse total shoulder replacement versus anatomical total shoulder replacement for osteoarthritis: population based cohort study using data from the National Joint Registry and Hospital Episode Statistics for England BMJ (IF 93.6) Pub Date : 2024-04-30 Epaminondas Markos Valsamis, Albert Prats-Uribe, Ian Koblbauer, Sophie Cole, Adrian Sayers, Michael R Whitehouse, Gillian Coward, Gary S Collins, Rafael Pinedo-Villanueva, Daniel Prieto-Alhambra, Jonathan L Rees
Objectives To answer a national research priority by comparing the risk-benefit and costs associated with reverse total shoulder replacement (RTSR) and anatomical total shoulder replacement (TSR) in patients having elective primary shoulder replacement for osteoarthritis. Design Population based cohort study using data from the National Joint Registry and Hospital Episode Statistics for England. Setting
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Prenatal opioid exposure and subsequent risk of neuropsychiatric disorders in children: nationwide birth cohort study in South Korea BMJ (IF 93.6) Pub Date : 2024-04-24 Jiseung Kang, Hyeon Jin Kim, Tae Kim, Hyeri Lee, Minji Kim, Seung Won Lee, Min Seo Kim, Ai Koyanagi, Lee Smith, Guillaume Fond, Laurent Boyer, Masoud Rahmati, Guillermo F López Sánchez, Elena Dragioti, Samuele Cortese, Jae Il Shin, Dong Keon Yon, Marco Solmi
Objective To investigate the potential association between prenatal opioid exposure and the risk of neuropsychiatric disorders in children. Design Nationwide birth cohort study. Setting From 1 January 2009 to 31 December 2020, birth cohort data of pregnant women in South Korea linked to their liveborn infants from the National Health Insurance Service of South Korea were collected. Participants All
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Effect of combination treatment with glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors on incidence of cardiovascular and serious renal events: population based cohort study BMJ (IF 93.6) Pub Date : 2024-04-25 Nikita Simms-Williams, Nir Treves, Hui Yin, Sally Lu, Oriana Yu, Richeek Pradhan, Christel Renoux, Samy Suissa, Laurent Azoulay
Objective To determine whether the combined use of glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter-2 (SGLT-2) inhibitors is associated with a decreased risk of major adverse cardiovascular events and serious renal events compared with either drug class alone among patients with type 2 diabetes, and to assess the effect of the combination on the individual components
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Multiple adverse outcomes associated with antipsychotic use in people with dementia: population based matched cohort study BMJ (IF 93.6) Pub Date : 2024-04-17 Pearl L H Mok, Matthew J Carr, Bruce Guthrie, Daniel R Morales, Aziz Sheikh, Rachel A Elliott, Elizabeth M Camacho, Tjeerd van Staa, Anthony J Avery, Darren M Ashcroft
Objective To investigate risks of multiple adverse outcomes associated with use of antipsychotics in people with dementia. Design Population based matched cohort study. Setting Linked primary care, hospital and mortality data from Clinical Practice Research Datalink (CPRD), England. Population Adults (≥50 years) with a diagnosis of dementia between 1 January 1998 and 31 May 2018 (n=173 910, 63.0% women)
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Predicting the risks of kidney failure and death in adults with moderate to severe chronic kidney disease BMJ (IF 93.6) Pub Date : 2024-04-15 Thomas Alexander Gerds, Pietro Ravani
The risk prediction model for kidney failure and death in people with chronic kidney disease (CKD) presented in the linked study is a super learner. A super learner is an algorithm that repeatedly splits the data into training and test sets and then chooses the best performing model from a list of candidate prediction models. This article describes why and how the super learner was implemented in the