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Association between changes in carbohydrate intake and long term weight changes: prospective cohort study BMJ (IF 105.7) Pub Date : 2023-09-27 Yi Wan, Deirdre K Tobias, Kristine K Dennis, Marta Guasch-Ferré, Qi Sun, Eric B Rimm, Frank B Hu, David S Ludwig, Orrin Devinsky, Walter C Willett
Objective To comprehensively examine the associations between changes in carbohydrate intake and weight change at four year intervals. Design Prospective cohort study. Setting Nurses’ Health Study (1986-2010), Nurses’ Health Study II (1991-2015), and Health Professionals Follow-Up Study (1986-2014). Participants 136 432 men and women aged 65 years or younger and free of diabetes, cancer, cardiovascular
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Association between recently raised anticholinergic burden and risk of acute cardiovascular events: nationwide case-case-time-control study BMJ (IF 105.7) Pub Date : 2023-09-27 Wei-Ching Huang, Avery Shuei-He Yang, Daniel Hsiang-Te Tsai, Shih-Chieh Shao, Swu-Jane Lin, Edward Chia-Cheng Lai
Objective To evaluate the association between recently raised anticholinergic burden and risk of acute cardiovascular events in older adults. Design Case-case-time-control study (ie, incorporating a case crossover design and a control crossover design consisting of future cases). Setting Taiwan’s National Health Insurance Research Database. Participants 317 446 adults aged ≥65 who were admitted to
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Future-case control crossover analysis for adjusting bias in case crossover studies BMJ (IF 105.7) Pub Date : 2023-09-27 Wei-Ching Huang, Edward Chia-Cheng Lai
This article outlines the issues of exposure time trends in the case crossover design and the implementation of the case-case-time-control design, a control crossover analysis using “future cases” to adjust the exposure time trends. The future-case control crossover analysis minimises the influence of constant time confounders, as well as the protopathic bias arising from exposure time trends. The
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Efficacy and safety of an inactivated virus-particle vaccine for SARS-CoV-2, BIV1-CovIran: randomised, placebo controlled, double blind, multicentre, phase 3 clinical trial BMJ (IF 105.7) Pub Date : 2023-09-21 Minoo Mohraz, Katayoun Vahdat, Seyyed-Hadi Ghamari, Mohsen Abbasi-Kangevari, Erfan Ghasemi, Yasaman Ghabdian, Negar Rezaei, Maryam Amini Pouya, Asghar Abdoli, Mohammad-Reza Malekpour, Keyvan Koohgir, Sahar Saeedi Moghaddam, Payam Tabarsi, Mohsen Moghadami, Farzin Khorvash, Rozita Khodashahi, Mohammadreza Salehi, Hamed Hosseini
Objective To report the efficacy, safety, and exploratory immunogenicity findings of two 5 µg doses of the BIV1-CovIran vaccine. Design Randomised, placebo controlled, double blind, multicentre, phase 3 clinical trial. Setting In six cities of Iran, including Bushehr, Isfahan, Karaj, Mashhad, Shiraz, and Tehran. The first vaccine or placebo injection of the first participant was on 16 May 2021 in Tehran
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Suboptimal gestational weight gain and neonatal outcomes in low and middle income countries: individual participant data meta-analysis BMJ (IF 105.7) Pub Date : 2023-09-21 Nandita Perumal, Dongqing Wang, Anne Marie Darling, Enju Liu, Molin Wang, Tahmeed Ahmed, Parul Christian, Kathryn G Dewey, Gilberto Kac, Stephen H Kennedy, Vishak Subramoney, Brittany Briggs, Wafaie W Fawzi
Objective To estimate the associations between gestational weight gain (GWG) during pregnancy and neonatal outcomes in low and middle income countries. Design Individual participant data meta-analysis. Setting Prospective pregnancy studies from 24 low and middle income countries. Main outcome measures Nine neonatal outcomes related to timing (preterm birth) and anthropometry (weight, length, and head
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Effect of invitation letter in language of origin on screening attendance: randomised controlled trial in BreastScreen Norway BMJ (IF 105.7) Pub Date : 2023-09-19 Solveig Hofvind, Nadia Iqbal, Jonas E Thy, Gunhild Mangerud, Sameer Bhargava, Sophia Zackrisson, Paula Berstad
Objective To explore attendance at organised mammographic screening among immigrant groups that received an invitation letter and information leaflet (invitation) in their language of origin and Norwegian compared with Norwegian only. Design Randomised controlled trial. Setting Population based screening programme for breast cancer in Norway (BreastScreen Norway), which invites women aged 50-69 to
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Provision of evaluation and management visits by nurse practitioners and physician assistants in the USA from 2013 to 2019: cross-sectional time series study BMJ (IF 105.7) Pub Date : 2023-09-14 Sadiq Y Patel, David Auerbach, Haiden A Huskamp, Austin Frakt, Hannah Neprash, Michael L Barnett, Hannah O James, Laura Barrie Smith, Ateev Mehrotra
Objective To examine the proportion of healthcare visits are delivered by nurse practitioners and physician assistants versus physicians and how this has changed over time and by clinical setting, diagnosis, and patient demographics. Design Cross-sectional time series study. Setting National data from the traditional Medicare insurance program in the USA. Participants Of people using Medicare (ie,
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Non-erosive gastro-oesophageal reflux disease and incidence of oesophageal adenocarcinoma in three Nordic countries: population based cohort study BMJ (IF 105.7) Pub Date : 2023-09-13 Dag Holmberg, Giola Santoni, My von Euler-Chelpin, Martti Färkkilä, Joonas H Kauppila, John Maret-Ouda, Eivind Ness-Jensen, Jesper Lagergren
Objective To assess the incidence rate of oesophageal adenocarcinoma among patients with non-erosive gastro-oesophageal reflux disease compared with the general population. Design Population based cohort study. Setting All patients in hospital and specialised outpatient healthcare in Denmark, Finland, and Sweden from 1 January 1987 to 31 December 2019. Participants 486 556 adults (>18 years) who underwent
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Food additive emulsifiers and risk of cardiovascular disease in the NutriNet-Santé cohort: prospective cohort study BMJ (IF 105.7) Pub Date : 2023-09-06 Laury Sellem, Bernard Srour, Guillaume Javaux, Eloi Chazelas, Benoit Chassaing, Emilie Viennois, Charlotte Debras, Clara Salamé, Nathalie Druesne-Pecollo, Younes Esseddik, Fabien Szabo de Edelenyi, Cédric Agaësse, Alexandre De Sa, Rebecca Lutchia, Erwan Louveau, Inge Huybrechts, Fabrice Pierre, Xavier Coumoul, Léopold K Fezeu, Chantal Julia, Emmanuelle Kesse-Guyot, Benjamin Allès, Pilar Galan, Serge
Objective To assess the associations between exposure to food additive emulsifiers and risk of cardiovascular disease (CVD). Design Prospective cohort study. Setting French NutriNet-Santé study, 2009-21. Participants 95 442 adults (>18 years) without prevalent CVD who completed at least three 24 hour dietary records during the first two years of follow-up. Main outcome measures Associations between
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Venous thromboembolism with use of hormonal contraception and non-steroidal anti-inflammatory drugs: nationwide cohort study BMJ (IF 105.7) Pub Date : 2023-09-06 Amani Meaidi, Annamaria Mascolo, Maurizio Sessa, Anne Pernille Toft-Petersen, Regitze Skals, Thomas Alexander Gerds, Charlotte Wessel Skovlund, Lina Steinrud Morch, Francesco Rossi, Annalisa Capuano, Oejvind Lidegaard, Christian Torp-Pedersen
Objective To study the influence of concomitant use of hormonal contraception and non-steroidal anti-inflammatory drugs (NSAIDs) on the risk of venous thromboembolism. Design Nationwide cohort study. Setting Denmark through national registries. Participants All 15-49 year old women living in Denmark between 1996 and 2017 with no medical history of any venous or arterial thrombotic event, cancer, thrombophilia
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Balancing risks and benefits of cannabis use: umbrella review of meta-analyses of randomised controlled trials and observational studies BMJ (IF 105.7) Pub Date : 2023-08-30 Marco Solmi, Marco De Toffol, Jong Yeob Kim, Min Je Choi, Brendon Stubbs, Trevor Thompson, Joseph Firth, Alessandro Miola, Giovanni Croatto, Francesca Baggio, Silvia Michelon, Luca Ballan, Björn Gerdle, Francesco Monaco, Pierluigi Simonato, Paolo Scocco, Valdo Ricca, Giovanni Castellini, Michele Fornaro, Andrea Murru, Eduard Vieta, Paolo Fusar-Poli, Corrado Barbui, John P A Ioannidis, Andrè F Carvalho
Objective To systematically assess credibility and certainty of associations between cannabis, cannabinoids, and cannabis based medicines and human health, from observational studies and randomised controlled trials (RCTs). Design Umbrella review. Data sources PubMed, PsychInfo, Embase, up to 9 February 2022. Eligibility criteria for selecting studies Systematic reviews with meta-analyses of observational
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Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial BMJ (IF 105.7) Pub Date : 2023-08-29 Rowan H Harwood, Sarah E Goldberg, Andrew Brand, Veronika van Der Wardt, Vicky Booth, Claudio Di Lorito, Zoe Hoare, Jennie Hancox, Rupinder Bajwa, Clare Burgon, Louise Howe, Alison Cowley, Trevor Bramley, Annabelle Long, Juliette Lock, Rachael Tucker, Emma J Adams, Rebecca O’Brien, Fiona Kearney, Katarzyna Kowalewska, Maureen Godfrey, Marianne Dunlop, Kehinde Junaid, Simon Thacker, Carol Duff, Tomas
Objective To determine the effectiveness of an exercise and functional activity therapy intervention in adults with early dementia or mild cognitive impairment compared with usual care. Design Randomised controlled trial. Setting Participants’ homes and communities at five sites in the United Kingdom. Participants 365 adults with early dementia or mild cognitive impairment who were living at home,
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Effect of home cook interventions for salt reduction in China: cluster randomised controlled trial BMJ (IF 105.7) Pub Date : 2023-08-24 Xiaochang Zhang, Puhong Zhang, Danyang Shen, Yuan Li, Feng J He, Jixiang Ma, Wei Yan, Yifu Gao, Donghui Jin, Ying Deng, Fangming Guo, Shichun Yan, Jing Song, Graham A MacGregor, Jing Wu
Objective To determine the effects of salt reduction interventions designed for home cooks and family members. Design Cluster randomised controlled trial. Setting Six provinces in northern, central, and southern China from 15 October 2018 to 30 December 2019. Participants 60 communities from six provinces (10 communities from each province) were randomised; each community comprised 26 people (two people
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Effect of a smartphone intervention as a secondary prevention for use among university students with unhealthy alcohol use: randomised controlled trial BMJ (IF 105.7) Pub Date : 2023-08-16 Nicolas Bertholet, Elodie Schmutz, Joseph Studer, Angéline Adam, Gerhard Gmel, John A Cunningham, Jennifer McNeely, Jean-Bernard Daeppen
Objective To estimate the effects of providing access to an alcohol intervention based on a smartphone. Design Randomised controlled trial.. Setting Four higher education institutions in Switzerland. Participants 1770 students (≥18 years) who screened positive for unhealthy alcohol use (ie, a score on the alcohol use disorders identification test-consumption (AUDIT-C) of ≥4 for men and ≥3 for women)
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Cancer mortality after low dose exposure to ionising radiation in workers in France, the United Kingdom, and the United States (INWORKS): cohort study BMJ (IF 105.7) Pub Date : 2023-08-16 David B Richardson, Klervi Leuraud, Dominique Laurier, Michael Gillies, Richard Haylock, Kaitlin Kelly-Reif, Stephen Bertke, Robert D Daniels, Isabelle Thierry-Chef, Monika Moissonnier, Ausrele Kesminiene, Mary K Schubauer-Berigan
Objective To evaluate the effect of protracted low dose, low dose rate exposure to ionising radiation on the risk of cancer. Design Multinational cohort study. Setting Cohorts of workers in the nuclear industry in France, the UK, and the US included in a major update to the International Nuclear Workers Study (INWORKS). Participants 309 932 workers with individual monitoring data for external exposure
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Long term risk of death and readmission after hospital admission with covid-19 among older adults: retrospective cohort study BMJ (IF 105.7) Pub Date : 2023-08-09 Andrew S Oseran, Yang Song, Jiaman Xu, Issa J Dahabreh, Rishi K Wadhera, James A de Lemos, Sandeep R Das, Tianyu Sun, Robert W Yeh, Dhruv S Kazi
Objectives To characterize the long term risk of death and hospital readmission after an index admission with covid-19 among Medicare fee-for-service beneficiaries, and to compare these outcomes with historical control patients admitted to hospital with influenza. Design Retrospective cohort study. Setting United States. Participants 883 394 Medicare fee-for-service beneficiaries age ≥65 years discharged
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The proportions of term or late preterm births after exposure to early antenatal corticosteroids, and outcomes: systematic review and meta-analysis of 1.6 million infants BMJ (IF 105.7) Pub Date : 2023-08-02 Kiran Ninan, Anja Gojic, Yanchen Wang, Elizabeth V Asztalos, Marc Beltempo, Kellie E Murphy, Sarah D McDonald
Objective To systematically review the proportions of infants with early exposure to antenatal corticosteroids but born at term or late preterm, and short term and long term outcomes. Design Systematic review and meta-analyses. Data sources Eight databases searched from 1 January 2000 to 1 February 2023, reflecting recent perinatal care, and references of screened articles. Eligibility criteria for
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Mortality rates among patients successfully treated for hepatitis C in the era of interferon-free antivirals: population based cohort study BMJ (IF 105.7) Pub Date : 2023-08-02 Victoria Hamill, Stanley Wong, Jennifer Benselin, Mel Krajden, Peter C Hayes, David Mutimer, Amanda Yu, John F Dillon, William Gelson, Hector A Velásquez García, Alan Yeung, Philip Johnson, Stephen T Barclay, Maria Alvarez, Hidenori Toyoda, Kosh Agarwal, Andrew Fraser, Sofia Bartlett, Mark Aldersley, Andy Bathgate, Mawuena Binka, Paul Richardson, Joanne R Morling, Stephen D Ryder, Douglas MacDonald
Objectives To quantify mortality rates for patients successfully treated for hepatitis C in the era of interferon-free, direct acting antivirals and compare these rates with those of the general population. Design Population based cohort study. Setting British Columbia, Scotland, and England (England cohort consists of patients with cirrhosis only). Participants 21 790 people who were successfully
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Association between antenatal corticosteroids and risk of serious infection in children: nationwide cohort study BMJ (IF 105.7) Pub Date : 2023-08-02 Tsung-Chieh Yao, Sheng-Mao Chang, Chi-Shin Wu, Yi-Fen Tsai, Kun-Hua Sheen, Xiumei Hong, Hui-Yu Chen, Ann Chen Wu, Hui-Ju Tsai
Objective To investigate the associations between exposure to antenatal corticosteroids and serious infection in children during the first three, six, and 12 months of life. Design Nationwide cohort study. Setting National Health Insurance Research Database, Birth Reporting Database, and Maternal and Child Health Database, 1 January 2008 to 31 December 2019, to identify all pregnant individuals and
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Comparative effectiveness of bivalent BA.4-5 and BA.1 mRNA booster vaccines among adults aged ≥50 years in Nordic countries: nationwide cohort study BMJ (IF 105.7) Pub Date : 2023-07-25 Niklas Worm Andersson, Emilia Myrup Thiesson, Ulrike Baum, Nicklas Pihlström, Jostein Starrfelt, Kristýna Faksová, Eero Poukka, Hinta Meijerink, Rickard Ljung, Anders Hviid
Objective To estimate the effectiveness of the bivalent mRNA booster vaccines containing the original SARS-CoV-2 and omicron BA.4-5 or BA.1 subvariants as the fourth dose against severe covid-19. Design Nationwide cohort analyses, using target trial emulation. Setting Denmark, Finland, Norway, and Sweden, from 1 July 2022 to 10 April 2023. Participants People aged ≥50 years who had received at least
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Safety of BA.4-5 or BA.1 bivalent mRNA booster vaccines: nationwide cohort study BMJ (IF 105.7) Pub Date : 2023-07-25 Niklas Worm Andersson, Emilia Myrup Thiesson, Jørgen Vinsløv Hansen, Anders Hviid
Objective To examine the association between the omicron adapted bivalent mRNA covid-19 booster vaccines received as a fourth dose and risk of adverse events. Design Nationwide cohort study. Setting Denmark. Participants 2 225 567 adults aged ≥50 years who received three covid-19 vaccine doses during the study period, 1 January 2021 to 10 December 2022. Main outcome measures The main outcome measure
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Comparative effectiveness of heterologous third dose vaccine schedules against severe covid-19 during omicron predominance in Nordic countries: population based cohort analyses BMJ (IF 105.7) Pub Date : 2023-07-24 Niklas Worm Andersson, Emilia Myrup Thiesson, Ulrike Baum, Nicklas Pihlström, Jostein Starrfelt, Kristýna Faksová, Eero Poukka, Lars Christian Lund, Christian Holm Hansen, Mia Aakjær, Jesper Kjær, Catherine Cohet, Mathijs Goossens, Morten Andersen, Jesper Hallas, Hinta Meijerink, Rickard Ljung, Anders Hviid
Objective To investigate the comparative vaccine effectiveness of heterologous booster schedules (ie, three vaccine doses) compared with primary schedules (two vaccine doses) and with homologous mRNA vaccine booster schedules (three vaccine doses) during a period of omicron predominance. Design Population based cohort analyses. Setting Denmark, Finland, Norway, and Sweden, 27 December 2020 to 31 December
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Associations between self-reported healthcare disruption due to covid-19 and avoidable hospital admission: evidence from seven linked longitudinal studies for England BMJ (IF 105.7) Pub Date : 2023-07-19 Mark A Green, Martin McKee, Olivia KL Hamilton, Richard J Shaw, John Macleod, Andy Boyd, Srinivasa Vittal Katikireddi
Objectives To examine whether there is an association between people who experienced disrupted access to healthcare during the covid-19 pandemic and risk of an avoidable hospital admission. Design Observational analysis using evidence from seven linked longitudinal cohort studies for England. Setting Studies linked to electronic health records from NHS Digital from 1 March 2020 to 25 August 2022. Data
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Evaluating trends in private equity ownership and impacts on health outcomes, costs, and quality: systematic review BMJ (IF 105.7) Pub Date : 2023-07-19 Alexander Borsa, Geronimo Bejarano, Moriah Ellen, Joseph Dov Bruch
Objective To review the evidence on trends and impacts of private equity (PE) ownership of healthcare operators. Design Systematic review. Data sources PubMed, Web of Science, Embase, Scopus, and SSRN. Eligibility criteria for study selection Empirical research studies of any design that evaluated PE owned healthcare operators. Main outcome measures The main outcome measures were impact of PE ownership
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Educational inequalities in mortality and their mediators among generations across four decades: nationwide, population based, prospective cohort study based on the ChinaHEART project BMJ (IF 105.7) Pub Date : 2023-07-19 Jiapeng Lu, Chaoqun Wu, Xiaoyan Zhang, Yang Yang, Jianlan Cui, Wei Xu, Lijuan Song, Hao Yang, Wenyan He, Yan Zhang, Jing Li, Xi Li
Objectives To assess the different educational inequalities in mortality among generations born between 1940 and 1979 in China, and to investigate the role of socioeconomic, behavioural, and metabolic factors as potential contributors to the reduction of educational inequalities. Design Nationwide, population based, prospective cohort study. Setting The ChinaHEART (China Health Evaluation And risk
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Association between Medicare eligibility at age 65 years and in-hospital treatment patterns and health outcomes for patients with trauma: regression discontinuity approach BMJ (IF 105.7) Pub Date : 2023-07-11 Deepon Bhaumik, Chima D Ndumele, John W Scott, Jacob Wallace
Objective To determine whether health systems in the United States modify treatment or discharge decisions for otherwise similar patients based on health insurance coverage. Design Regression discontinuity approach. Setting American College of Surgeons’ National Trauma Data Bank, 2007-17. Participants Adults aged between 50 and 79 years with a total of 1 586 577 trauma encounters at level I and level
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Prevalence and predictors of data and code sharing in the medical and health sciences: systematic review with meta-analysis of individual participant data BMJ (IF 105.7) Pub Date : 2023-07-11 Daniel G Hamilton, Kyungwan Hong, Hannah Fraser, Anisa Rowhani-Farid, Fiona Fidler, Matthew J Page
Objectives To synthesise research investigating data and code sharing in medicine and health to establish an accurate representation of the prevalence of sharing, how this frequency has changed over time, and what factors influence availability. Design Systematic review with meta-analysis of individual participant data. Data sources Ovid Medline, Ovid Embase, and the preprint servers medRxiv, bioRxiv
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Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study BMJ (IF 105.7) Pub Date : 2023-07-05 Kerstin N Vokinger, Camille E G Glaus, Aaron S Kesselheim, Miquel Serra-Burriel, Joseph S Ross, Thomas J Hwang
Objective To analyze the therapeutic value of supplemental indications compared with first indications for drugs approved in the US and Europe. Design Retrospective cohort study. Setting New and supplemental indications approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) between 2011 and 2020. Main outcome measures Proportion of first and supplemental indications
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Hospital admissions linked to SARS-CoV-2 infection in children and adolescents: cohort study of 3.2 million first ascertained infections in England BMJ (IF 105.7) Pub Date : 2023-07-05 Harrison Wilde, Christopher Tomlinson, Bilal A Mateen, David Selby, Hari Krishnan Kanthimathinathan, Padmanabhan Ramnarayan, Pascale Du Pre, Mae Johnson, Nazima Pathan, Arturo Gonzalez-Izquierdo, Alvina G Lai, Deepti Gurdasani, Christina Pagel, Spiros Denaxas, Sebastian Vollmer, Katherine Brown
Objective To describe hospital admissions associated with SARS-CoV-2 infection in children and adolescents. Design Cohort study of 3.2 million first ascertained SARS-CoV-2 infections using electronic health care record data. Setting England, July 2020 to February 2022. Participants About 12 million children and adolescents (age <18 years) who were resident in England. Main outcome measures Ascertainment
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Menopausal hormone therapy and dementia: nationwide, nested case-control study BMJ (IF 105.7) Pub Date : 2023-06-28 Nelsan Pourhadi, Lina S Mørch, Ellen A Holm, Christian Torp-Pedersen, Amani Meaidi
Objectives To assess the association between use of menopausal hormone therapy and development of dementia according to type of hormone treatment, duration of use, and age at usage. Design Nationwide, nested case-control study. Setting Denmark through national registries. Participants 5589 incident cases of dementia and 55 890 age matched controls were identified between 2000 and 2018 from a population
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Vitamin D supplementation and major cardiovascular events: D-Health randomised controlled trial BMJ (IF 105.7) Pub Date : 2023-06-28 Bridie Thompson, Mary Waterhouse, Dallas R English, Donald S McLeod, Bruce K Armstrong, Catherine Baxter, Briony Duarte Romero, Peter R Ebeling, Gunter Hartel, Michael G Kimlin, Sabbir T Rahman, Jolieke C van der Pols, Alison J Venn, Penelope M Webb, David C Whiteman, Rachel E Neale
Objective To investigate whether supplementing older adults with monthly doses of vitamin D alters the incidence of major cardiovascular events. Design Randomised, double blind, placebo controlled trial of monthly vitamin D (the D-Health Trial). Computer generated permuted block randomisation was used to allocate treatments. Setting Australia from 2014 to 2020. Participants 21 315 participants aged
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Associations between modest reductions in kidney function and adverse outcomes in young adults: retrospective, population based cohort study BMJ (IF 105.7) Pub Date : 2023-06-23 Junayd Hussain, Nicholas Grubic, Ayub Akbari, Mark Canney, Meghan J Elliott, Pietro Ravani, Peter Tanuseputro, Edward G Clark, Gregory L Hundemer, Tim Ramsay, Navdeep Tangri, Greg A Knoll, Manish M Sood
Abstract Objective To study age specific associations of modest reductions in estimated glomerular filtration rate (eGFR) with adverse outcomes. Design Retrospective, population based cohort study. Setting Linked healthcare administrative datasets in Ontario, Canada. Participants Adult residents (18-65 years) with at least one outpatient eGFR value (categorized in 10 unit increments from 50 mL/min/1
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Association between surgeon volume and patient outcomes after elective shoulder replacement surgery using data from the National Joint Registry and Hospital Episode Statistics for England: population based cohort study BMJ (IF 105.7) Pub Date : 2023-06-21 Epaminondas Markos Valsamis, Gary S Collins, Rafael Pinedo-Villanueva, Michael R Whitehouse, Amar Rangan, Adrian Sayers, Jonathan L Rees
Objective To investigate the association between surgeon volume and patient outcomes after elective shoulder replacement surgery to improve patient outcomes and inform future resource planning for joint replacement surgery. Design Prospective cohort study. Setting Public and private hospitals in the United Kingdom, 2012-20. Participants Adults aged 18 years or older who had shoulder replacement surgery
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Risk prediction of covid-19 related death or hospital admission in adults testing positive for SARS-CoV-2 infection during the omicron wave in England (QCOVID4): cohort study BMJ (IF 105.7) Pub Date : 2023-06-21 Julia Hippisley-Cox, Kamlesh Khunti, Aziz Sheikh, Jonathan S Nguyen-Van-Tam, Carol A C Coupland
Objectives To derive and validate risk prediction algorithms (QCOVID4) to estimate the risk of covid-19 related death and hospital admission in people with a positive SARS-CoV-2 test result during the period when the omicron variant of the virus was predominant in England, and to evaluate performance compared with a high risk cohort from NHS Digital. Design Cohort study. Setting QResearch database
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Effectiveness of GRACE risk score in patients admitted to hospital with non-ST elevation acute coronary syndrome (UKGRIS): parallel group cluster randomised controlled trial BMJ (IF 105.7) Pub Date : 2023-06-14 Chris P Gale, Deborah D Stocken, Suleman Aktaa, Catherine Reynolds, Rachael Gilberts, David Brieger, Kathryn Carruthers, Derek P Chew, Shaun G Goodman, Catherine Fernandez, Linda D Sharples, Andrew T Yan, Keith Fox
Objective To determine the effectiveness of risk stratification using the Global Registry of Acute Coronary Events (GRACE) risk score (GRS) for patients presenting to hospital with suspected non-ST elevation acute coronary syndrome. Design Parallel group cluster randomised controlled trial. Setting Patients presenting with suspected non-ST elevation acute coronary syndrome to 42 hospitals in England
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Breast cancer mortality in 500 000 women with early invasive breast cancer in England, 1993-2015: population based observational cohort study BMJ (IF 105.7) Pub Date : 2023-06-13 Carolyn Taylor, Paul McGale, Jake Probert, John Broggio, Jackie Charman, Sarah C Darby, Amanda J Kerr, Timothy Whelan, David J Cutter, Gurdeep Mannu, David Dodwell
Objectives To describe long term breast cancer mortality among women with a diagnosis of breast cancer in the past and estimate absolute breast cancer mortality risks for groups of patients with a recent diagnosis. Design Population based observational cohort study. Setting Routinely collected data from the National Cancer Registration and Analysis Service. Participants All 512 447 women registered
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Analysis of peer reviewers’ response to invitations by gender and geographical region: cohort study of manuscripts reviewed at 21 biomedical journals before and during covid-19 pandemic BMJ (IF 105.7) Pub Date : 2023-06-13 Khaoula Ben Messaoud, Sara Schroter, Mark Richards, Angèle Gayet-Ageron
Objectives To describe gender and geographical inequalities in invitations to review and the response to these invitations and to assess whether inequalities increased during the covid-19 pandemic. Design Retrospective cohort study. Setting 19 specialist medical journals and two large general medical journals from BMJ Publishing Group. Population Reviewers invited to review manuscripts submitted between
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Measles, mumps, and rubella vaccine at age 6 months and hospitalisation for infection before age 12 months: randomised controlled trial BMJ (IF 105.7) Pub Date : 2023-06-07 Anne Cathrine Zimakoff, Andreas Jensen, Dorthe Maria Vittrup, Emma Hoppe Herlufsen, Jesper Kiehn Sørensen, Michelle Malon, Jannet Svensson, Lone Graff Stensballe
Objective To test for potential non-specific effects of an additional, early measles, mumps, and rubella (MMR) vaccine at age 5-7 months on risk of infection related hospitalisation before age 12 months. Design Randomised, double blinded, placebo controlled trial. Setting Denmark, a high income setting with low exposure to MMR. Participants 6540 Danish infants aged 5 to 7 months. Interventions Infants
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Race-free estimated glomerular filtration rate equation in kidney transplant recipients: development and validation study BMJ (IF 105.7) Pub Date : 2023-05-31 Marc Raynaud, Solaf Al-Awadhi, Ivana Juric, Gillian Divard, Yannis Lombardi, Nikolina Basic-Jukic, Olivier Aubert, Laurence Dubourg, Ingrid Masson, Christophe Mariat, Dominique Prié, Vincent Pernin, Moglie Le Quintrec, Timothy S Larson, Mark D Stegall, Boris Bikbov, Piero Ruggenenti, Laurent Mesnard, Hassan N Ibrahim, Marie Bodilsen Nielsen, Arthur J Matas, Brian J Nankivell, Stan Benjamens, Robert
Objective To compare the performance of a newly developed race-free kidney recipient specific glomerular filtration rate (GFR) equation with the three current main equations for measuring GFR in kidney transplant recipients. Design Development and validation study Setting 17 cohorts in Europe, the United States, and Australia (14 transplant centres, three clinical trials). Participants 15 489 adults
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Recovery and symptom trajectories up to two years after SARS-CoV-2 infection: population based, longitudinal cohort study BMJ (IF 105.7) Pub Date : 2023-05-31 Tala Ballouz, Dominik Menges, Alexia Anagnostopoulos, Anja Domenghino, Hélène E Aschmann, Anja Frei, Jan S Fehr, Milo A Puhan
Objective To evaluate longer term symptoms and health outcomes associated with post-covid-19 condition within a cohort of individuals with a SARS-CoV-2 infection. Design Population based, longitudinal cohort. Setting General population of canton of Zurich, Switzerland. Participants 1106 adults with a confirmed SARS-CoV-2 infection who were not vaccinated before infection and 628 adults who did not
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Risk stratified monitoring for methotrexate toxicity in immune mediated inflammatory diseases: prognostic model development and validation using primary care data from the UK BMJ (IF 105.7) Pub Date : 2023-05-30 Georgina Nakafero, Matthew J Grainge, Hywel C Williams, Tim Card, Maarten W Taal, Guruprasad P Aithal, Christopher P Fox, Christian D Mallen, Danielle A van der Windt, Matthew D Stevenson, Richard D Riley, Abhishek Abhishek
Objective To develop and validate a prognostic model to inform risk stratified decisions on frequency of monitoring blood tests during long term methotrexate treatment. Design Retrospective cohort study. Setting Electronic health records within the UK’s Clinical Practice Research Datalink (CPRD) Gold and CPRD Aurum. Participants Adults (≥18 years) with a diagnosis of an immune mediated inflammatory
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Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies: the CoPPS Statement BMJ (IF 105.7) Pub Date : 2023-05-25 David Hohenschurz-Schmidt, Lene Vase, Whitney Scott, Marco Annoni, Oluwafemi K Ajayi, Jürgen Barth, Kim Bennell, Chantal Berna, Joel Bialosky, Felicity Braithwaite, Nanna B Finnerup, Amanda C de C Williams, Elisa Carlino, Francesco Cerritelli, Aleksander Chaibi, Dan Cherkin, Luana Colloca, Pierre Côté, Beth D Darnall, Roni Evans, Laurent Fabre, Vanda Faria, Simon French, Heike Gerger, Winfried Häuser
Control interventions (often called “sham,” “placebo,” or “attention controls”) are essential for studying the efficacy or mechanism of physical, psychological, and self-management interventions in clinical trials. This article presents core recommendations for designing, conducting, and reporting control interventions to establish a quality standard in non-pharmacological intervention research. A
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Optimising prescribing in older adults with multimorbidity and polypharmacy in primary care (OPTICA): cluster randomised clinical trial BMJ (IF 105.7) Pub Date : 2023-05-24 Katharina Tabea Jungo, Anna-Katharina Ansorg, Carmen Floriani, Zsofia Rozsnyai, Nathalie Schwab, Rahel Meier, Fabio Valeri, Odile Stalder, Andreas Limacher, Claudio Schneider, Michael Bagattini, Sven Trelle, Marco Spruit, Matthias Schwenkglenks, Nicolas Rodondi, Sven Streit
Objective To study the effects of a primary care medication review intervention centred around an electronic clinical decision support system (eCDSS) on appropriateness of medication and the number of prescribing omissions in older adults with multimorbidity and polypharmacy compared with a discussion about medication in line with usual care. Design Cluster randomised clinical trial. Setting Swiss
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Adverse outcomes of SARS-CoV-2 infection with delta and omicron variants in vaccinated versus unvaccinated US veterans: retrospective cohort study BMJ (IF 105.7) Pub Date : 2023-05-23 Amy SB Bohnert, Kyle Kumbier, Mazhgan Rowneki, Ashwin Gupta, Kristina Bajema, Denise M Hynes, Elizabeth Viglianti, Ann M O’Hare, Thomas Osborne, Edward J Boyko, Yinong Young-Xu, Theodore J Iwashyna, Matthew Maciejewski, Richard Schildhouse, Derek Dimcheff, George N Ioannou
Objectives To determine the association between covid-19 vaccination types and doses with adverse outcomes of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection during the periods of delta (B.1.617.2) and omicron (B.1.1.529) variant predominance. Design Retrospective cohort. Setting US Veterans Affairs healthcare system. Participants Adults (≥18 years) who are affiliated to Veterans
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Women and non-white people among Lasker Award recipients from 1946 to 2022: cross sectional study BMJ (IF 105.7) Pub Date : 2023-05-17 Jeremy W Jacobs, Lorin A Bibb, Elizabeth S Allen, Dawn C Ward, Garrett S Booth, Julie K Silver, Brian D Adkins
Objective To determine whether gender and racial inequities exist among Lasker Award recipients. Design Observational, cross sectional analysis. Setting Population based study. Participants Recipients of four Lasker Awards from 1946 to 2022. Main outcome measures Gender and race (non-white categorized as racialized v white categorized as non-racialized) of all Lasker Award recipients. Personal characteristics
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Effectiveness of spironolactone for women with acne vulgaris (SAFA) in England and Wales: pragmatic, multicentre, phase 3, double blind, randomised controlled trial BMJ (IF 105.7) Pub Date : 2023-05-16 Miriam Santer, Megan Lawrence, Susanne Renz, Zina Eminton, Beth Stuart, Tracey H Sach, Sarah Pyne, Matthew J Ridd, Nick Francis, Irene Soulsby, Karen Thomas, Natalia Permyakova, Paul Little, Ingrid Muller, Jacqui Nuttall, Gareth Griffiths, Kim S Thomas, Alison M Layton
Objective To assess the effectiveness of oral spironolactone for acne vulgaris in adult women. Design Pragmatic, multicentre, phase 3, double blind, randomised controlled trial. Setting Primary and secondary healthcare, and advertising in the community and on social media in England and Wales. Participants Women (≥18 years) with facial acne for at least six months, judged to warrant oral antibiotics
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Association between inequalities in human resources for health and all cause and cause specific mortality in 172 countries and territories, 1990-2019: observational study BMJ (IF 105.7) Pub Date : 2023-05-10 Wenxin Yan, Chenyuan Qin, Liyuan Tao, Xin Guo, Qiao Liu, Min Du, Lin Zhu, Zhongdan Chen, Wannian Liang, Min Liu, Jue Liu
Objective To explore inequalities in human resources for health (HRH) in relation to all cause and cause specific mortality globally in 1990-2019. Design Observational study. Setting 172 countries and territories. Data sources Databases of the Global Burden of Disease Study 2019, United Nations Statistics, and Our World in Data. Main outcome measures The main outcome was age standardized all cause
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Development and internal-external validation of statistical and machine learning models for breast cancer prognostication: cohort study BMJ (IF 105.7) Pub Date : 2023-05-10 Ash Kieran Clift, David Dodwell, Simon Lord, Stavros Petrou, Michael Brady, Gary S Collins, Julia Hippisley-Cox
Objective To develop a clinically useful model that estimates the 10 year risk of breast cancer related mortality in women (self-reported female sex) with breast cancer of any stage, comparing results from regression and machine learning approaches. Design Population based cohort study. Setting QResearch primary care database in England, with individual level linkage to the national cancer registry
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FDA approval, clinical trial evidence, efficacy, epidemiology, and price for non-orphan and ultra-rare, rare, and common orphan cancer drug indications: cross sectional analysis BMJ (IF 105.7) Pub Date : 2023-05-09 Thomas Michaeli, Hendrik Jürges, Daniel Tobias Michaeli
Objective To analyze the US Food and Drug Administration (FDA) approval, trials, unmet needs, benefit, and pricing of ultra-rare (<6600 affected US citizens), rare (6600-200 000 citizens), and common (>200 000 citizens) orphan cancer drug indications and non-orphan cancer drug indications. Design Cross sectional analysis. Setting Data from Drugs@FDA, FDA labels, Global Burden of Disease study, and
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Association between SARS-CoV-2 vaccination and healthcare contacts for menstrual disturbance and bleeding in women before and after menopause: nationwide, register based cohort study BMJ (IF 105.7) Pub Date : 2023-05-03 Rickard Ljung, YiYi Xu, Anders Sundström, Susannah Leach, Ebba Hallberg, Maria Bygdell, Maria Larsson, Veronica Arthurson, Magnus Gisslén, Rolf Gedeborg, Fredrik Nyberg
Objectives To evaluate the risks of any menstrual disturbance and bleeding following SARS-CoV-2 vaccination in women who are premenopausal or postmenopausal. Design A nationwide, register based cohort study. Setting All inpatient and specialised outpatient care in Sweden from 27 December 2020 to 28 February 2022. A subset covering primary care for 40% of the Swedish female population was also included
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Association of early life physical and sexual abuse with premature mortality among female nurses: prospective cohort study BMJ (IF 105.7) Pub Date : 2023-05-03 Yi-Xin Wang, Yang Sun, Stacey A Missmer, Kathryn M Rexrode, Andrea L Roberts, Jorge E Chavarro, Janet W Rich-Edwards
Objective To explore associations between early life physical and sexual abuse and subsequent risk of premature mortality (death before age 70 years). Design Prospective cohort study. Setting The Nurses’ Health Study II (2001-19). Participants 67 726 female nurses aged 37-54 years when completing a violence victimization questionnaire in 2001. Main outcome measures Hazard ratios and 95% confidence
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Transparent reporting of multivariable prediction models for individual prognosis or diagnosis: checklist for systematic reviews and meta-analyses (TRIPOD-SRMA) BMJ (IF 105.7) Pub Date : 2023-05-03 Kym I E Snell, Brooke Levis, Johanna A A Damen, Paula Dhiman, Thomas P A Debray, Lotty Hooft, Johannes B Reitsma, Karel G M Moons, Gary S Collins, Richard D Riley
Most clinical specialties have a plethora of studies that develop or validate one or more prediction models, for example, to inform diagnosis or prognosis. Having many prediction model studies in a particular clinical field motivates the need for systematic reviews and meta-analyses, to evaluate and summarise the overall evidence available from prediction model studies, in particular about the predictive
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Fracture risk reduction and safety by osteoporosis treatment compared with placebo or active comparator in postmenopausal women: systematic review, network meta-analysis, and meta-regression analysis of randomised clinical trials BMJ (IF 105.7) Pub Date : 2023-05-02 Mina Nicole Händel, Isabel Cardoso, Cecilie von Bülow, Jeanett Friis Rohde, Anja Ussing, Sabrina Mai Nielsen, Robin Christensen, Jean-Jacques Body, Maria Luisa Brandi, Adolfo Diez-Perez, Peyman Hadji, Muhammad Kassim Javaid, Willem Frederik Lems, Xavier Nogues, Christian Roux, Salvatore Minisola, Andreas Kurth, Thierry Thomas, Daniel Prieto-Alhambra, Serge Livio Ferrari, Bente Langdahl, Bo Abrahamsen
Objective To review the comparative effectiveness of osteoporosis treatments, including the bone anabolic agents, abaloparatide and romosozumab, on reducing the risk of fractures in postmenopausal women, and to characterise the effect of antiosteoporosis drug treatments on the risk of fractures according to baseline risk factors. Design Systematic review, network meta-analysis, and meta-regression
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Multi-faceted intervention to improve management of antibiotics for children presenting to primary care with acute cough and respiratory tract infection (CHICO): efficient cluster randomised controlled trial BMJ (IF 105.7) Pub Date : 2023-04-26 Peter S Blair, Grace Young, Clare Clement, P Dixon, Penny Seume, Jenny Ingram, Jodi Taylor, Christie Cabral, Patricia J Lucas, Elizabeth Beech, Jeremy Horwood, Martin Gulliford, Nick A Francis, Sam Creavin, Janet A Lane, Scott Bevan, Alistair D Hay
Objective To assess whether an easy-to-use multifaceted intervention for children presenting to primary care with respiratory tract infections would reduce antibiotic dispensing, without increasing hospital admissions for respiratory tract infection. Design Two arm randomised controlled trial clustered by general practice, using routine outcome data, with qualitative and economic evaluations. Setting
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Molnupiravir and risk of post-acute sequelae of covid-19: cohort study BMJ (IF 105.7) Pub Date : 2023-04-25 Yan Xie, Taeyoung Choi, Ziyad Al-Aly
Objective To examine whether treatment with the antiviral agent molnupiravir during the first five days of SARS-CoV-2 infection is associated with reduced risk of post-acute adverse health outcomes. Design Cohort study. Setting US Department of Veterans Affairs. Participants 229 286 participants who tested positive for SARS-CoV-2 between 5 January 2022 and 15 January 2023, had at least one risk factor
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CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials BMJ (IF 105.7) Pub Date : 2023-04-24 Daniela R Junqueira, Liliane Zorzela, Susan Golder, Yoon Loke, Joel J Gagnier, Steven A Julious, Tianjing Li, Evan Mayo-Wilson, Ba Pham, Rachel Phillips, Pasqualina Santaguida, Roberta W Scherer, Peter C Gøtzsche, David Moher, John P A Ioannidis, Sunita Vohra
Randomised controlled trials remain the reference standard for healthcare research on effects of interventions, and the need to report both benefits and harms is essential. The Consolidated Standards of Reporting Trials (the main CONSORT) statement includes one item on reporting harms (ie, all important harms or unintended effects in each group). In 2004, the CONSORT group developed the CONSORT Harms
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Surgical versus non-surgical treatment for sciatica: systematic review and meta-analysis of randomised controlled trials BMJ (IF 105.7) Pub Date : 2023-04-19 Chang Liu, Giovanni E Ferreira, Christina Abdel Shaheed, Qiuzhe Chen, Ian A Harris, Christopher S Bailey, Wilco C Peul, Bart Koes, Chung-Wei Christine Lin
Objective To investigate the effectiveness and safety of surgery compared with non-surgical treatment for sciatica. Design Systematic review and meta-analysis. Data sources Medline, Embase, CINAHL, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and the World Health Organisation International Clinical Trials Registry Platform from database inception to June 2022. Eligibility criteria
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Beverage consumption and mortality among adults with type 2 diabetes: prospective cohort study BMJ (IF 105.7) Pub Date : 2023-04-19 Le Ma, Yang Hu, Derrick J Alperet, Gang Liu, Vasanti Malik, JoAnn E Manson, Eric B Rimm, Frank B Hu, Qi Sun
Objective To investigate the intake of specific types of beverages in relation to mortality and cardiovascular disease (CVD) outcomes among adults with type 2 diabetes. Design Prospective cohort study. Setting Health professionals in the United States. Participants 15 486 men and women with a diagnosis of type 2 diabetes at baseline and during follow-up (Nurses’ Health Study: 1980-2018; and Health
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Denosumab and incidence of type 2 diabetes among adults with osteoporosis: population based cohort study BMJ (IF 105.7) Pub Date : 2023-04-18 Houchen Lyu, Sizheng Steven Zhao, Licheng Zhang, Jie Wei, Xiaoxiao Li, Hui Li, Yi Liu, Pengbin Yin, Vibeke Norvang, Kazuki Yoshida, Sara K Tedeschi, Chao Zeng, Guanghua Lei, Peifu Tang, Daniel H Solomon
Objective To estimate the effect of denosumab compared with oral bisphosphonates on reducing the risk of type 2 diabetes in adults with osteoporosis. Design Population based study involving emulation of a randomized target trial using electronic health records. Setting IQVIA Medical Research Data primary care database in the United Kingdom, 1995-2021. Participants Adults aged 45 years or older who
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Nirmatrelvir and risk of hospital admission or death in adults with covid-19: emulation of a randomized target trial using electronic health records BMJ (IF 105.7) Pub Date : 2023-04-11 Yan Xie, Benjamin Bowe, Ziyad Al-Aly
Objective To estimate the effectiveness of nirmatrelvir, compared with no treatment, in reducing admission to hospital or death at 30 days in people infected with the SARS-CoV-2 virus and at risk of developing severe disease, according to vaccination status and history of previous SARS-CoV-2 infection. Design Emulation of a randomized target trial with electronic health records. Setting Healthcare