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Reporting guideline for overviews of reviews of healthcare interventions: development of the PRIOR statement BMJ (IF 93.333) Pub Date : 2022-08-09 Michelle Gates, Allison Gates, Dawid Pieper, Ricardo M Fernandes, Andrea C Tricco, David Moher, Sue E Brennan, Tianjing Li, Michelle Pollock, Carole Lunny, Dino Sepúlveda, Joanne E McKenzie, Shannon D Scott, Karen A Robinson, Katja Matthias, Konstantinos I Bougioukas, Paolo Fusar-Poli, Penny Whiting, Stephana J Moss, Lisa Hartling
Objective To develop a reporting guideline for overviews of reviews of healthcare interventions. Design Development of the preferred reporting items for overviews of reviews (PRIOR) statement. Participants Core team (seven individuals) led day-to-day operations, and an expert advisory group (three individuals) provided methodological advice. A panel of 100 experts (authors, editors, readers including
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Role of human papillomavirus (HPV) vaccination on HPV infection and recurrence of HPV related disease after local surgical treatment: systematic review and meta-analysis BMJ (IF 93.333) Pub Date : 2022-08-03 Konstantinos S Kechagias, Ilkka Kalliala, Sarah J Bowden, Antonios Athanasiou, Maria Paraskevaidi, Evangelos Paraskevaidis, Joakim Dillner, Pekka Nieminen, Bjorn Strander, Peter Sasieni, Areti Angeliki Veroniki, Maria Kyrgiou
Objective To explore the efficacy of human papillomavirus (HPV) vaccination on the risk of HPV infection and recurrent diseases related to HPV infection in individuals undergoing local surgical treatment. Design Systematic review and meta-analysis Data sources PubMed (Medline), Scopus, Cochrane, Web of Science, and ClinicalTrials.gov were screened from inception to 31 March 2021. Review methods Studies
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Response to acute monotherapy for major depressive disorder in randomized, placebo controlled trials submitted to the US Food and Drug Administration: individual participant data analysis BMJ (IF 93.333) Pub Date : 2022-08-02 Marc B Stone, Zimri S Yaseen, Brian J Miller, Kyle Richardville, Shamir N Kalaria, Irving Kirsch
Objectives To characterize individual participant level response distributions to acute monotherapy for major depressive disorder in randomized, placebo controlled trials submitted to the US Food and Drug Administration from 1979 to 2016. Design Individual participant data analysis. Population 232 randomized, double blind, placebo controlled trials of drug monotherapy for major depressive disorder
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Risk of covid-19 related deaths for SARS-CoV-2 omicron (B.1.1.529) compared with delta (B.1.617.2): retrospective cohort study BMJ (IF 93.333) Pub Date : 2022-08-02 Isobel L Ward, Charlotte Bermingham, Daniel Ayoubkhani, Owen J Gethings, Koen B Pouwels, Thomas Yates, Kamlesh Khunti, Julia Hippisley-Cox, Amitava Banerjee, Ann Sarah Walker, Vahé Nafilyan
Objective To assess the risk of covid-19 death after infection with omicron BA.1 compared with delta (B.1.617.2). Design Retrospective cohort study. Setting England, United Kingdom, from 1 December 2021 to 30 December 2021. Participants 1 035 149 people aged 18-100 years who tested positive for SARS-CoV-2 under the national surveillance programme and had an infection identified as omicron BA.1 or delta
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Clinical features and novel presentations of human monkeypox in a central London centre during the 2022 outbreak: descriptive case series BMJ (IF 93.333) Pub Date : 2022-07-28 Aatish Patel, Julia Bilinska, Jerry C H Tam, Dayana Da Silva Fontoura, Claire Y Mason, Anna Daunt, Luke B Snell, Jamie Murphy, Jack Potter, Cecilia Tuudah, Rohan Sundramoorthi, Movin Abeywickrema, Caitlin Pley, Vasanth Naidu, Gaia Nebbia, Emma Aarons, Alina Botgros, Sam T Douthwaite, Claire van Nispen tot Pannerden, Helen Winslow, Aisling Brown, Daniella Chilton, Achyuta Nori
Objective To characterise the clinical features of monkeypox infection in humans. Design Descriptive case series. Setting A regional high consequences infectious disease centre with associated primary and secondary care referrals, and affiliated sexual health centres in south London between May and July 2022. Participants 197 patients with polymerase chain reaction confirmed monkeypox infection. Results
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Burden of chronic obstructive pulmonary disease and its attributable risk factors in 204 countries and territories, 1990-2019: results from the Global Burden of Disease Study 2019 BMJ (IF 93.333) Pub Date : 2022-07-27 Saeid Safiri, Kristin Carson-Chahhoud, Maryam Noori, Seyed Aria Nejadghaderi, Mark J M Sullman, Javad Ahmadian Heris, Khalil Ansarin, Mohammad Ali Mansournia, Gary S Collins, Ali-Asghar Kolahi, Jay S Kaufman
Objective To report the global, regional, and national burden of chronic obstructive pulmonary disease (COPD) and its attributable risk factors between 1990 and 2019, by age, sex, and sociodemographic index. Design Systematic analysis. Data source Global Burden of Disease Study 2019. Main outcome measures Data on the prevalence, deaths, and disability adjusted life years (DALYs) of COPD, and its attributable
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Prognosis and persistence of smell and taste dysfunction in patients with covid-19: meta-analysis with parametric cure modelling of recovery curves BMJ (IF 93.333) Pub Date : 2022-07-27 Benjamin Kye Jyn Tan, Ruobing Han, Joseph J Zhao, Nicole Kye Wen Tan, Emrick Sen Hui Quah, Claire Jing-Wen Tan, Yiong Huak Chan, Neville Wei Yang Teo, Tze Choong Charn, Anna See, Shuhui Xu, Nikita Chapurin, Rakesh K Chandra, Naweed Chowdhury, Rafal Butowt, Christopher S von Bartheld, B Nirmal Kumar, Claire Hopkins, Song Tar Toh
Objective To clarify in patients with covid-19 the recovery rate of smell and taste, proportion with persistent dysfunction of smell and taste, and prognostic factors associated with recovery of smell and taste. Design Systematic review and meta-analysis. Data sources PubMed, Embase, Scopus, Cochrane Library, and medRxiv from inception to 3 October 2021. Review methods Two blinded reviewers selected
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Waning effectiveness of BNT162b2 and ChAdOx1 covid-19 vaccines over six months since second dose: OpenSAFELY cohort study using linked electronic health records BMJ (IF 93.333) Pub Date : 2022-07-20 Elsie M F Horne, William J Hulme, Ruth H Keogh, Tom M Palmer, Elizabeth J Williamson, Edward P K Parker, Amelia Green, Venexia Walker, Alex J Walker, Helen Curtis, Louis Fisher, Brian MacKenna, Richard Croker, Lisa Hopcroft, Robin Y Park, Jon Massey, Jessica Morley, Amir Mehrkar, Sebastian Bacon, David Evans, Peter Inglesby, Caroline E Morton, George Hickman, Simon Davy, Tom Ward, Iain Dillingham,
Objective To estimate waning of covid-19 vaccine effectiveness over six months after second dose. Design Cohort study, approved by NHS England. Setting Linked primary care, hospital, and covid-19 records within the OpenSAFELY-TPP database. Participants Adults without previous SARS-CoV-2 infection were eligible, excluding care home residents and healthcare professionals. Exposures People who had received
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Burden of SARS-CoV-2 infection in healthcare workers during second wave in England and impact of vaccines: prospective multicentre cohort study (SIREN) and mathematical model BMJ (IF 93.333) Pub Date : 2022-07-20 Diane Pople, Edward J M Monk, Stephanie Evans, Sarah Foulkes, Jasmin Islam, Edgar Wellington, Ana Atti, Russell Hope, Julie Robotham, Susan Hopkins, Colin S Brown, Victoria J Hall
Objective To describe the incidence of, risk factors for, and impact of vaccines on primary SARS-CoV-2 infection during the second wave of the covid-19 pandemic in susceptible hospital healthcare workers in England. Design Multicentre prospective cohort study. Setting National Health Service secondary care health organisations (trusts) in England between 1 September 2020 and 30 April 2021. Participants
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Comparative effectiveness of ChAdOx1 versus BNT162b2 covid-19 vaccines in health and social care workers in England: cohort study using OpenSAFELY BMJ (IF 93.333) Pub Date : 2022-07-20 William J Hulme, Elizabeth J Williamson, Amelia C A Green, Krishnan Bhaskaran, Helen I McDonald, Christopher T Rentsch, Anna Schultze, John Tazare, Helen J Curtis, Alex J Walker, Laurie A Tomlinson, Tom Palmer, Elsie M F Horne, Brian MacKenna, Caroline E Morton, Amir Mehrkar, Jessica Morley, Louis Fisher, Sebastian C J Bacon, David Evans, Peter Inglesby, George Hickman, Simon Davy, Tom Ward, Richard
Objective To compare the effectiveness of the BNT162b2 mRNA (Pfizer-BioNTech) and the ChAdOx1 (Oxford-AstraZeneca) covid-19 vaccines against infection and covid-19 disease in health and social care workers. Design Cohort study, emulating a comparative effectiveness trial, on behalf of NHS England. Setting Linked primary care, hospital, and covid-19 surveillance records available within the OpenSAFELY-TPP
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Incidence, risk factors, natural history, and hypothesised mechanisms of myocarditis and pericarditis following covid-19 vaccination: living evidence syntheses and review BMJ (IF 93.333) Pub Date : 2022-07-13 Jennifer Pillay, Lindsay Gaudet, Aireen Wingert, Liza Bialy, Andrew S Mackie, D Ian Paterson, Lisa Hartling
Objectives To synthesise evidence on incidence rates and risk factors for myocarditis and pericarditis after use of mRNA vaccination against covid-19, clinical presentation, short term and longer term outcomes of cases, and proposed mechanisms. Design Living evidence syntheses and review. Data sources Medline, Embase, and the Cochrane Library were searched from 6 October 2020 to 10 January 2022; reference
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Safety of heterologous primary and booster schedules with ChAdOx1-S and BNT162b2 or mRNA-1273 vaccines: nationwide cohort study BMJ (IF 93.333) Pub Date : 2022-07-13 Niklas Worm Andersson, Emilia Myrup Thiesson, Mona Vestergaard Laursen, Stine Hasling Mogensen, Jesper Kjær, Anders Hviid
Objective To assess the risk of adverse events associated with heterologous primary (two dose) and booster (three dose) vaccine schedules for covid-19 with Oxford-AstraZeneca’s ChAdOx1-S priming followed by mRNA vaccines (Pfizer-BioNTech’s BNT162b2 or Moderna’s mRNA-1273) as compared with homologous mRNA vaccine schedules for covid-19. Design Nationwide cohort study. Setting Denmark, 1 January 2021
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Clinical prediction models for mortality in patients with covid-19: external validation and individual participant data meta-analysis BMJ (IF 93.333) Pub Date : 2022-07-12 Valentijn M T de Jong, Rebecca Z Rousset, Neftalí Eduardo Antonio-Villa, Arnoldus G Buenen, Ben Van Calster, Omar Yaxmehen Bello-Chavolla, Nigel J Brunskill, Vasa Curcin, Johanna A A Damen, Carlos A Fermín-Martínez, Luisa Fernández-Chirino, Davide Ferrari, Robert C Free, Rishi K Gupta, Pranabashis Haldar, Pontus Hedberg, Steven Kwasi Korang, Steef Kurstjens, Ron Kusters, Rupert W Major, Lauren Maxwell
Objective To externally validate various prognostic models and scoring rules for predicting short term mortality in patients admitted to hospital for covid-19. Design Two stage individual participant data meta-analysis. Setting Secondary and tertiary care. Participants 46 914 patients across 18 countries, admitted to a hospital with polymerase chain reaction confirmed covid-19 from November 2019 to
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Fever therapy in febrile adults: systematic review with meta-analyses and trial sequential analyses BMJ (IF 93.333) Pub Date : 2022-07-12 Johan Holgersson, Ameldina Ceric, Naqash Sethi, Niklas Nielsen, Janus Christian Jakobsen
Objective To investigate the effects of fever therapy compared with no fever therapy in a wide population of febrile adults. Design Systematic review with meta-analyses and trial sequential analyses of randomised clinical trials. Data sources CENTRAL, BIOSIS, CINAHL, MEDLINE, Embase, LILACS, Scopus, and Web of Science Core Collection, searched from their inception to 2 July 2021. Eligibility criteria
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Viscosupplementation for knee osteoarthritis: systematic review and meta-analysis BMJ (IF 93.333) Pub Date : 2022-07-06 Tiago V Pereira, Peter Jüni, Pakeezah Saadat, Dan Xing, Liang Yao, Pavlos Bobos, Arnav Agarwal, Cesar A Hincapié, Bruno R da Costa
Objective To evaluate the effectiveness and safety of viscosupplementation for pain and function in patients with knee osteoarthritis. Design Systematic review and meta-analysis of randomised trials. Data sources Searches were conducted of Medline, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) databases from inception to 11 September 2021. Unpublished trials were identified
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Serious adverse event rates and reoperation after arthroscopic shoulder surgery: population based cohort study BMJ (IF 93.333) Pub Date : 2022-07-06 Jonathan L Rees, Richard Craig, Navraj Nagra, Mathew Baldwin, Jennifer C E Lane, Andrew Price, David J Beard, Simon Abram, Andrew Judge, Daniel Prieto-Alhambra, Dominic Furniss, Andrew J Carr
Objective To provide clinicians and patients with accurate risk estimates of serious adverse events after common elective shoulder arthroscopic procedures, including reoperation within one year. Design Population based cohort study. Setting Hospital Episode Statistics for NHS England, including civil registration mortality data from the Office for National Statistics. Participants 288 250 arthroscopic
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Effectiveness of a fourth dose of covid-19 mRNA vaccine against the omicron variant among long term care residents in Ontario, Canada: test negative design study BMJ (IF 93.333) Pub Date : 2022-07-06 Ramandip Grewal, Sophie A Kitchen, Lena Nguyen, Sarah A Buchan, Sarah E Wilson, Andrew P Costa, Jeffrey C Kwong
Objectives To estimate the marginal effectiveness of a fourth versus third dose and the vaccine effectiveness of mRNA covid-19 vaccines BNT162b2 and mRNA-1273 against any infection, symptomatic infection, and severe outcomes (hospital admission or death) related to the omicron variant. Design Test negative design. Setting Long term care facilities in Ontario, Canada, 30 December 2021 to 27 April 2022
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Racial bias and reproducibility in pulse oximetry among medical and surgical inpatients in general care in the Veterans Health Administration 2013-19: multicenter, retrospective cohort study BMJ (IF 93.333) Pub Date : 2022-07-06 Valeria S M Valbuena, Sarah Seelye, Michael W Sjoding, Thomas S Valley, Robert P Dickson, Steven E Gay, Dru Claar, Hallie C Prescott, Theodore J Iwashyna
Objectives To evaluate measurement discrepancies by race between pulse oximetry and arterial oxygen saturation (as measured in arterial blood gas) among inpatients not in intensive care. Design Multicenter, retrospective cohort study using electronic medical records from general care medical and surgical inpatients. Setting Veteran Health Administration, a national and racially diverse integrated health
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Anticoagulants for thrombosis prophylaxis in acutely ill patients admitted to hospital: systematic review and network meta-analysis BMJ (IF 93.333) Pub Date : 2022-07-04 Ruben J Eck, Tessa Elling, Alex J Sutton, Jørn Wetterslev, Christian Gluud, Iwan C C van der Horst, Reinold O B Gans, Karina Meijer, Frederik Keus
Objective To assess the benefits and harms of different types and doses of anticoagulant drugs for the prevention of venous thromboembolism in patients who are acutely ill and admitted to hospital. Design Systematic review and network meta-analysis. Data sources Cochrane CENTRAL, PubMed/Medline, Embase, Web of Science, clinical trial registries, and national health authority databases. The search was
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Long distance airborne transmission of SARS-CoV-2: rapid systematic review BMJ (IF 93.333) Pub Date : 2022-06-29 Daphne Duval, Jennifer C Palmer, Isobel Tudge, Nicola Pearce-Smith, Emer O’Connell, Allan Bennett, Rachel Clark
Objectives To evaluate the potential for long distance airborne transmission of SARS-CoV-2 in indoor community settings and to investigate factors that might influence transmission. Design Rapid systematic review and narrative synthesis. Data sources Medline, Embase, medRxiv, Arxiv, and WHO COVID-19 Research Database for studies published from 27 July 2020 to 19 January 2022; existing relevant rapid
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Dipeptidyl peptidase-4 inhibitors and gallbladder or biliary disease in type 2 diabetes: systematic review and pairwise and network meta-analysis of randomised controlled trials BMJ (IF 93.333) Pub Date : 2022-06-28 Liyun He, Jialu Wang, Fan Ping, Na Yang, Jingyue Huang, Wei Li, Lingling Xu, Huabing Zhang, Yuxiu Li
Objective To examine the association between dipeptidyl peptidase-4 inhibitors and gallbladder or biliary diseases. Design Systematic review and pairwise and network meta-analysis. Data sources PubMed, EMBASE, Web of Science, and CENTRAL from inception until 31 July 2021. Eligibility criteria Randomised controlled trials of adult patients with type 2 diabetes who received dipeptidyl peptidase-4 inhibitors
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User centered clinical decision support to implement initiation of buprenorphine for opioid use disorder in the emergency department: EMBED pragmatic cluster randomized controlled trial BMJ (IF 93.333) Pub Date : 2022-06-27 Edward R Melnick, Bidisha Nath, James D Dziura, Martin F Casey, Molly M Jeffery, Hyung Paek, William E Soares, Jason A Hoppe, Haseena Rajeevan, Fangyong Li, Rachel M Skains, Lauren A Walter, Mehul D Patel, Srihari V Chari, Timothy F Platts-Mills, Erik P Hess, Gail D’Onofrio
Objective To determine the effect of a user centered clinical decision support tool versus usual care on rates of initiation of buprenorphine in the routine emergency care of individuals with opioid use disorder. Design Pragmatic cluster randomized controlled trial (EMBED). Setting 18 emergency department clusters across five healthcare systems in five states representing the north east, south east
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Infertility, recurrent pregnancy loss, and risk of stroke: pooled analysis of individual patient data of 618 851 women BMJ (IF 93.333) Pub Date : 2022-06-22 Chen Liang, Hsin-Fang Chung, Annette J Dobson, Kunihiko Hayashi, Yvonne T van der Schouw, Diana Kuh, Rebecca Hardy, Carol A Derby, Samar R El Khoudary, Imke Janssen, Sven Sandin, Elisabete Weiderpass, Gita D Mishra
Objective To examine the associations of infertility, recurrent miscarriage, and stillbirth with the risk of first non-fatal and fatal stroke, further stratified by stroke subtypes. Design Individual participant pooled analysis of eight prospective cohort studies. Setting Cohort studies across seven countries (Australia, China, Japan, Netherlands, Sweden, the United Kingdom, and the United States)
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Industry sponsorship bias in cost effectiveness analysis: registry based analysis BMJ (IF 93.333) Pub Date : 2022-06-22 Feng Xie, Ting Zhou
Objective To assess the association between industry sponsorship (drug, medical device, and biotechnology companies) and cost effectiveness results in cost effectiveness analysis (CEA). Design Registry based analysis Data source The Tufts Cost-Effectiveness Analysis Registry was used to identify all CEAs published in Medline between 1976 and 2021. Eligibility criteria for selecting studies CEAs that
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The evidence base for US joint commission hospital accreditation standards: cross sectional study BMJ (IF 93.333) Pub Date : 2022-06-23 Sarah A Ibrahim, Kelly A Reynolds, Emily Poon, Murad Alam
Objective To evaluate the evidence upon which standards for hospital accreditation by The Joint Commission on Accreditation of Healthcare Organizations (the Joint Commission) are based. Design Cross sectional study. Setting United States. Participants Four Joint Commission R3 (requirement, rationale, and reference) reports released by July 2018 and intended to become effective between 1 July 2018 and
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Guided, internet based, cognitive behavioural therapy for post-traumatic stress disorder: pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID) BMJ (IF 93.333) Pub Date : 2022-06-16 Jonathan I Bisson, Cono Ariti, Katherine Cullen, Neil Kitchiner, Catrin Lewis, Neil P Roberts, Natalie Simon, Kim Smallman, Katy Addison, Vicky Bell, Lucy Brookes-Howell, Sarah Cosgrove, Anke Ehlers, Deborah Fitzsimmons, Paula Foscarini-Craggs, Shaun R S Harris, Mark Kelson, Karina Lovell, Maureen McKenna, Rachel McNamara, Claire Nollett, Tim Pickles, Rhys Williams-Thomas
Objective To determine if guided internet based cognitive behavioural therapy with a trauma focus (CBT-TF) is non-inferior to individual face-to-face CBT-TF for mild to moderate post-traumatic stress disorder (PTSD) to one traumatic event. Design Pragmatic, multicentre, randomised controlled non-inferiority trial (RAPID). Setting Primary and secondary mental health settings across the UK’s NHS. Participants
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Change in covid-19 risk over time following vaccination with CoronaVac: test negative case-control study BMJ (IF 93.333) Pub Date : 2022-06-13 Matt D T Hitchings, Otavio T Ranzani, Margaret L Lind, Murilo Dorion, Tatiana Lang D’Agostini, Regiane Cardoso de Paula, Olivia Ferreira Pereira de Paula, Edlaine Faria de Moura Villela, Mario Sergio Scaramuzzini Torres, Silvano Barbosa de Oliveira, Wade Schulz, Maria Almiron, Rodrigo Said, Roberto Dias de Oliveira, Patricia Vieira da Silva, Wildo Navegantes de Araújo, Jean Carlo Gorinchteyn, Natalie
Objective To estimate the change in odds of covid-19 over time following primary series completion of the inactivated whole virus vaccine CoronaVac (Sinovac Biotech) in São Paulo State, Brazil. Design Test negative case-control study. Setting Community testing for covid-19 in São Paulo State, Brazil. Participants Adults aged ≥18 years who were residents of São Paulo state, had received two doses of
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Development and validation of a decision support tool for the diagnosis of acute heart failure: systematic review, meta-analysis, and modelling study BMJ (IF 93.333) Pub Date : 2022-06-13 Kuan Ken Lee, Dimitrios Doudesis, Mohamed Anwar, Federica Astengo, Camille Chenevier-Gobeaux, Yann-Erick Claessens, Desiree Wussler, Nikola Kozhuharov, Ivo Strebel, Zaid Sabti, Christopher deFilippi, Stephen Seliger, Gordon Moe, Carlos Fernando, Antoni Bayes-Genis, Roland R J van Kimmenade, Yigal Pinto, Hanna K Gaggin, Jan C Wiemer, Martin Möckel, Joost H W Rutten, Anton H van den Meiracker, Luna Gargani
Objectives To evaluate the diagnostic performance of N-terminal pro-B-type natriuretic peptide (NT-proBNP) thresholds for acute heart failure and to develop and validate a decision support tool that combines NT-proBNP concentrations with clinical characteristics. Design Individual patient level data meta-analysis and modelling study. Setting Fourteen studies from 13 countries, including randomised
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Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis BMJ (IF 93.333) Pub Date : 2022-06-10 Rebecca J Williams, Heather D Dobbins, Tony Tse, Sandy D Chon, David Loose, Gisele A Sarosy, Sheila A Prindiville, Frank W Rockhold, Deborah A Zarin
Objective To describe an approach for reporting master protocol research programs (MPRPs) that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy. Design Qualitative analysis. Data sources ClinicalTrials.gov trial registry. Main outcome measures Established goals and related practices of the trial
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Political environment and mortality rates in the United States, 2001-19: population based cross sectional analysis BMJ (IF 93.333) Pub Date : 2022-06-07 Haider J Warraich, Pankaj Kumar, Khurram Nasir, Karen E Joynt Maddox, Rishi K Wadhera
Objective To assess recent trends in age adjusted mortality rates (AAMRs) in the United States based on county level presidential voting patterns. Design Cross sectional study. Setting USA, 2001-19. Participants 99.8% of the US population. Main outcome measures AAMR per 100 000 population and average annual percentage change (APC). Methods The Centers for Disease Control and Prevention WONDER database
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Extension of cervical screening intervals with primary human papillomavirus testing: observational study of English screening pilot data BMJ (IF 93.333) Pub Date : 2022-05-31 Matejka Rebolj, Kate Cuschieri, Christopher S Mathews, Francesca Pesola, Karin Denton, Henry Kitchener
Objectives To provide updated evidence about the risk of cervical intraepithelial neoplasia grade 3 or higher (CIN3+) and cervical cancer after a negative human papillomavirus (HPV) test in primary cervical screening, by age group and test assay. Design Observational study. Setting Real world data from the English HPV screening pilot’s first and second rounds (2013-16, follow-up to end of 2019). Participants
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Effectiveness of heterologous and homologous covid-19 vaccine regimens: living systematic review with network meta-analysis BMJ (IF 93.333) Pub Date : 2022-05-31 Wing Ying Au, Peter Pak-Hang Cheung
Objective To evaluate the effectiveness of heterologous and homologous covid-19 vaccine regimens with and without boosting in preventing covid-19 related infection, hospital admission, and death. Design Living systematic review and network meta-analysis. Data sources World Health Organization covid-19 databases, including 38 sources of published studies and preprints. Study selection Randomised controlled
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Update to living systematic review on covid-19 in pregnancy BMJ (IF 93.333) Pub Date : 2022-05-30 British Medical Journal Publishing Group
This living systematic review on coronavirus disease 2019 (covid-19) by Allotey and colleagues ( BMJ 2020;370:m3320) has been updated. For the latest update, visit doi:10.1136/bmj.m3320. This …
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Effectiveness of weight management interventions for adults delivered in primary care: systematic review and meta-analysis of randomised controlled trials BMJ (IF 93.333) Pub Date : 2022-05-30 Claire D Madigan, Henrietta E Graham, Elizabeth Sturgiss, Victoria E Kettle, Kajal Gokal, Greg Biddle, Gemma M J Taylor, Amanda J Daley
Objective To examine the effectiveness of behavioural weight management interventions for adults with obesity delivered in primary care. Design Systematic review and meta-analysis of randomised controlled trials. Eligibility criteria for selection of studies Randomised controlled trials of behavioural weight management interventions for adults with a body mass index ≥25 delivered in primary care compared
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Gestational diabetes mellitus and adverse pregnancy outcomes: systematic review and meta-analysis BMJ (IF 93.333) Pub Date : 2022-05-25 Wenrui Ye, Cong Luo, Jing Huang, Chenglong Li, Zhixiong Liu, Fangkun Liu
Objective To investigate the association between gestational diabetes mellitus and adverse outcomes of pregnancy after adjustment for at least minimal confounding factors. Design Systematic review and meta-analysis. Data sources Web of Science, PubMed, Medline, and Cochrane Database of Systematic Reviews, from 1 January 1990 to 1 November 2021. Review methods Cohort studies and control arms of trials
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Effect of active vitamin D treatment on development of type 2 diabetes: DPVD randomised controlled trial in Japanese population BMJ (IF 93.333) Pub Date : 2022-05-25 Tetsuya Kawahara, Gen Suzuki, Shoichi Mizuno, Tetsuya Inazu, Fumiyoshi Kasagi, Chie Kawahara, Yosuke Okada, Yoshiya Tanaka
Objective To assess whether eldecalcitol, an active vitamin D analogue2, can reduce the development of type 2 diabetes among adults with impaired glucose tolerance. Design Double blinded, multicentre, randomised, placebo controlled trial. Setting Three hospitals in Japan, between June 2013 and August 2019. Participants People aged 30 years and older who had impaired glucose tolerance defined by using
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Short term, relative effectiveness of four doses versus three doses of BNT162b2 vaccine in people aged 60 years and older in Israel: retrospective, test negative, case-control study BMJ (IF 93.333) Pub Date : 2022-05-24 Sivan Gazit, Yaki Saciuk, Galit Perez, Asaf Peretz, Virginia E Pitzer, Tal Patalon
Objective To examine the relative effectiveness of a fourth dose of the Pfizer-BioNTech mRNA (BNT162b2) vaccine compared with three vaccine doses over the span of 10 weeks. Design Retrospective, test negative, case-control study, with a matched analysis and an unmatched multiple tests analysis. Setting Nationally centralised database of Maccabi Healthcare Services, an Israeli national health fund for
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Trajectory of long covid symptoms after covid-19 vaccination: community based cohort study BMJ (IF 93.333) Pub Date : 2022-05-18 Daniel Ayoubkhani, Charlotte Bermingham, Koen B Pouwels, Myer Glickman, Vahé Nafilyan, Francesco Zaccardi, Kamlesh Khunti, Nisreen A Alwan, A Sarah Walker
Objective To estimate associations between covid-19 vaccination and long covid symptoms in adults with SARS-CoV-2 infection before vaccination. Design Observational cohort study. Setting Community dwelling population, UK. Participants 28 356 participants in the Office for National Statistics COVID-19 Infection Survey aged 18-69 years who received at least one dose of an adenovirus vector or mRNA covid-19
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Long term impact of prophylactic antibiotic use before incision versus after cord clamping on children born by caesarean section: longitudinal study of UK electronic health records BMJ (IF 93.333) Pub Date : 2022-05-17 Dana Šumilo, Krishnarajah Nirantharakumar, Brian H Willis, Gavin M Rudge, James Martin, Krishna Gokhale, Rasiah Thayakaran, Nicola J Adderley, Joht Singh Chandan, Kelvin Okoth, Isobel M Harris, Ruth Hewston, Magdalena Skrybant, Jonathan J Deeks, Peter Brocklehurst
Objective To investigate the impact on child health up to age 5 years of a policy to use antibiotic prophylaxis for caesarean section before incision compared with after cord clamping. Design Observational controlled interrupted time series study. Setting UK primary and secondary care. Participants 515 945 children born in 2006-18 with linked maternal records and registered with general practices contributing
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Visualising harms in publications of randomised controlled trials: consensus and recommendations BMJ (IF 93.333) Pub Date : 2022-05-16 Rachel Phillips, Suzie Cro, Graham Wheeler, Simon Bond, Tim P Morris, Siobhan Creanor, Catherine Hewitt, Sharon Love, Andre Lopes, Iryna Schlackow, Carrol Gamble, Graeme MacLennan, Chris Habron, Anthony C Gordon, Nikhil Vergis, Tianjing Li, Riaz Qureshi, Colin C Everett, Jane Holmes, Amanda Kirkham, Clare Peckitt, Sarah Pirrie, Norin Ahmed, Laura Collett, Victoria Cornelius
Objective To improve communication of harm in publications of randomised controlled trials via the development of recommendations for visually presenting harm outcomes. Design Consensus study. Setting 15 clinical trials units registered with the UK Clinical Research Collaboration, an academic population health department, Roche Products, and The BMJ . Participants Experts in clinical trials: 20 academic
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Multicomponent intervention to prevent mobility disability in frail older adults: randomised controlled trial (SPRINTT project) BMJ (IF 93.333) Pub Date : 2022-05-11 Roberto Bernabei, Francesco Landi, Riccardo Calvani, Matteo Cesari, Susanna Del Signore, Stefan D Anker, Raphael Bejuit, Philippe Bordes, Antonio Cherubini, Alfonso J Cruz-Jentoft, Mauro Di Bari, Tim Friede, Carmen Gorostiaga Ayestarán, Harmonie Goyeau, Pálmi V Jónsson, Makoto Kashiwa, Fabrizia Lattanzio, Marcello Maggio, Luca Mariotti, Ram R Miller, Leocadio Rodriguez-Mañas, Regina Roller-Wirnsberger
Objective To determine whether a multicomponent intervention based on physical activity with technological support and nutritional counselling prevents mobility disability in older adults with physical frailty and sarcopenia. Design Evaluator blinded, randomised controlled trial. Setting 16 clinical sites across 11 European countries, January 2016 to 31 October 2019. Participants 1519 community dwelling
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Agreement of treatment effects from observational studies and randomized controlled trials evaluating hydroxychloroquine, lopinavir-ritonavir, or dexamethasone for covid-19: meta-epidemiological study BMJ (IF 93.333) Pub Date : 2022-05-10 Osman Moneer, Garrison Daly, Joshua J Skydel, Kate Nyhan, Peter Lurie, Joseph S Ross, Joshua D Wallach
Objective To systematically identify, match, and compare treatment effects and study demographics from individual or meta-analysed observational studies and randomized controlled trials (RCTs) evaluating the same covid-19 treatments, comparators, and outcomes. Design Meta-epidemiological study. Data sources National Institutes of Health Covid-19 Treatment Guidelines, a living review and network meta-analysis
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Validity of data extraction in evidence synthesis practice of adverse events: reproducibility study BMJ (IF 93.333) Pub Date : 2022-05-10 Chang Xu, Tianqi Yu, Luis Furuya-Kanamori, Lifeng Lin, Liliane Zorzela, Xiaoqin Zhou, Hanming Dai, Yoon Loke, Sunita Vohra
Objectives To investigate the validity of data extraction in systematic reviews of adverse events, the effect of data extraction errors on the results, and to develop a classification framework for data extraction errors to support further methodological research. Design Reproducibility study. Data sources PubMed was searched for eligible systematic reviews published between 1 January 2015 and 1 January
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PCSK9 inhibitors and ezetimibe with or without statin therapy for cardiovascular risk reduction: a systematic review and network meta-analysis BMJ (IF 93.333) Pub Date : 2022-05-04 Safi U Khan, Siva H Yedlapati, Ahmad N Lone, Qiukui Hao, Gordon Guyatt, Nicolas Delvaux, Geertruida E (Trudy) Bekkering, Per Olav Vandvik, Irbaz Bin Riaz, Sheyu Li, Bert Aertgeerts, Nicolas Rodondi
Objective To compare the impact of ezetimibe and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors on cardiovascular outcomes in adults taking maximally tolerated statin therapy or who are statin intolerant. Design Network meta-analysis. Data sources Medline, EMBASE, and Cochrane Library up to 31 December 2020. Eligibility criteria for selecting studies Randomised controlled trials of
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Variation in revascularisation use and outcomes of patients in hospital with acute myocardial infarction across six high income countries: cross sectional cohort study BMJ (IF 93.333) Pub Date : 2022-05-04 Peter Cram, Laura A Hatfield, Pieter Bakx, Amitava Banerjee, Christina Fu, Michal Gordon, Renaud Heine, Nicole Huang, Dennis Ko, Lisa M Lix, Victor Novack, Laura Pasea, Feng Qiu, Therese A Stukel, Carin Uyl de Groot, Lin Yan, Bruce Landon
Objectives To compare treatment and outcomes for patients admitted to hospital with a primary diagnosis of ST elevation or non-ST elevation myocardial infarction (STEMI or NSTEMI) in six high income countries with very different healthcare delivery systems. Design Retrospective cross sectional cohort study. Setting Patient level administrative data from the United States, Canada (Ontario and Manitoba)
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Venovenous extracorporeal membrane oxygenation in patients with acute covid-19 associated respiratory failure: comparative effectiveness study BMJ (IF 93.333) Pub Date : 2022-05-04 Martin Urner, Adrian G Barnett, Gianluigi Li Bassi, Daniel Brodie, Heidi J Dalton, Niall D Ferguson, Silver Heinsar, Carol L Hodgson, Giles Peek, Kiran Shekar, Jacky Y Suen, John F Fraser, Eddy Fan
Objective To estimate the effect of extracorporeal membrane oxygenation (ECMO) compared with conventional mechanical ventilation on outcomes of patients with covid-19 associated respiratory failure. Design Observational study. Setting 30 countries across five continents, 3 January 2020 to 29 August 2021. Participants 7345 adults admitted to the intensive care unit with clinically suspected or laboratory
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Exploratory analyses in aetiologic research and considerations for assessment of credibility: mini-review of literature BMJ (IF 93.333) Pub Date : 2022-05-03 Kim Luijken, Olaf M Dekkers, Frits R Rosendaal, Rolf H H Groenwold
Objective To provide considerations for reporting and interpretation that can improve assessment of the credibility of exploratory analyses in aetiologic research. Design Mini-review of the literature and account of exploratory research principles. Setting This study focuses on a particular type of causal research, namely aetiologic studies, which investigate the causal effect of one or multiple risk
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Public health impact of covid-19 vaccines in the US: observational study BMJ (IF 93.333) Pub Date : 2022-04-27 Amitabh Bipin Suthar, Jing Wang, Victoria Seffren, Ryan E Wiegand, Sean Griffing, Elizabeth Zell
Objective To evaluate the impact of vaccine scale-up on population level covid-19 mortality and incidence in the United States. Design Observational study. Setting US county level case surveillance and vaccine administration data reported from 14 December 2020 to 18 December 2021. Participants Residents of 2558 counties from 48 US states. Main outcome measures The primary outcome was county covid-19
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Development and validation of the symptom burden questionnaire for long covid (SBQ-LC): Rasch analysis BMJ (IF 93.333) Pub Date : 2022-04-27 Sarah E Hughes, Shamil Haroon, Anuradhaa Subramanian, Christel McMullan, Olalekan L Aiyegbusi, Grace M Turner, Louise Jackson, Elin Haf Davies, Chris Frost, Gary McNamara, Gary Price, Karen Matthews, Jennifer Camaradou, Jane Ormerod, Anita Walker, Melanie J Calvert
Objective To describe the development and validation of a novel patient reported outcome measure for symptom burden from long covid, the symptom burden questionnaire for long covid (SBQ-LC). Design Multiphase, prospective mixed methods study. Setting Remote data collection and social media channels in the United Kingdom, 14 April to 1 August 2021. Participants 13 adults (aged ≥18 years) with self-reported
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Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial BMJ (IF 93.333) Pub Date : 2022-04-19 Zhihao Lu, Junye Wang, Yongqian Shu, Lianke Liu, Li Kong, Lei Yang, Buhai Wang, Guogui Sun, Yinghua Ji, Guochun Cao, Hu Liu, Tongjian Cui, Na Li, Wensheng Qiu, Gaofeng Li, Xinfang Hou, Hui Luo, Liying Xue, Yanqiao Zhang, Wenbin Yue, Zheng Liu, Xiuwen Wang, Shegan Gao, Yueyin Pan, Marie-Pierre Galais, Aziz Zaanan, Zhuo Ma, Haoyu Li, Yan Wang, Lin Shen
Objective To evaluate sintilimab versus placebo in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil) as first line treatment of unresectable locally advanced, recurrent, or metastatic oesophageal squamous cell carcinoma. Design Multicentre, randomised, double blind, phase 3 trial. Setting 66 sites in China and 13 sites outside of China between 14 December 2018
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Healthy lifestyle and life expectancy with and without Alzheimer’s dementia: population based cohort study BMJ (IF 93.333) Pub Date : 2022-04-13 Klodian Dhana, Oscar H Franco, Ethan M Ritz, Christopher N Ford, Pankaja Desai, Kristin R Krueger, Thomas M Holland, Anisa Dhana, Xiaoran Liu, Neelum T Aggarwal, Denis A Evans, Kumar B Rajan
Objective To determine the impact of lifestyle factors on life expectancy lived with and without Alzheimer’s dementia. Design Prospective cohort study. Setting The Chicago Health and Aging Project, a population based cohort study in the United States. Participants 2449 men and women aged 65 years and older. Main exposure A healthy lifestyle score was developed based on five modifiable lifestyle factors:
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Multifaceted intervention to reduce haemodialysis catheter related bloodstream infections: REDUCCTION stepped wedge, cluster randomised trial BMJ (IF 93.333) Pub Date : 2022-04-12 Sradha Kotwal, Alan Cass, Sarah Coggan, Nicholas A Gray, Stephen Jan, Stephen McDonald, Kevan R Polkinghorne, Kris Rogers, Girish Talaulikar, Gian Luca Di Tanna, Martin Gallagher
Objective To identify whether multifaceted interventions, or care bundles, reduce catheter related bloodstream infections (CRBSIs) from central venous catheters used for haemodialysis. Design Stepped wedge, cluster randomised design. Setting 37 renal services across Australia. Participants All adults (age ≥18 years) under the care of a renal service who required insertion of a new haemodialysis catheter
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Risk of adverse events after covid-19 in Danish children and adolescents and effectiveness of BNT162b2 in adolescents: cohort study BMJ (IF 93.333) Pub Date : 2022-04-11 Helene Kildegaard, Lars Christian Lund, Mikkel Højlund, Lone Graff Stensballe, Anton Pottegård
Objectives To assess the risk of acute and post-acute adverse events after SARS-CoV-2 infection in children and adolescents in Denmark and to evaluate the real world effectiveness of the BNT162b2 mRNA vaccine (Pfizer-BioNTech) among adolescents. Design Cohort study. Setting Nationwide Danish healthcare registers. Participants All Danish people younger than 18 years who were either tested for SARS-CoV-2
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The self-controlled case series method and covid-19 BMJ (IF 93.333) Pub Date : 2022-04-06 Paddy Farrington
The self-controlled case series method is one of two approaches used to estimate the association between covid-19 and venous thromboembolism or bleeding. This article briefly describes the method, its assumptions, and how it was implemented in the linked study, and offers some pointers to guide the interpretation of the results. The self-controlled case series method is an epidemiological design for
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Clinical effectiveness of one ultrasound guided intra-articular corticosteroid and local anaesthetic injection in addition to advice and education for hip osteoarthritis (HIT trial): single blind, parallel group, three arm, randomised controlled trial BMJ (IF 93.333) Pub Date : 2022-04-06 Zoe Paskins, Kieran Bromley, Martyn Lewis, Gemma Hughes, Emily Hughes, Susie Hennings, Andrea Cherrington, Alison Hall, Melanie A Holden, Kay Stevenson, Ajit Menon, Philip Roberts, George Peat, Clare Jinks, Jesse Kigozi, Raymond Oppong, Nadine E Foster, Christian D Mallen, Edward Roddy
Objective To compare the clinical effectiveness of adding a single ultrasound guided intra-articular hip injection of corticosteroid and local anaesthetic to advice and education in adults with hip osteoarthritis. Design Pragmatic, three arm, parallel group, single blind, randomised controlled trial. Setting Two community musculoskeletal services in England. Participants 199 adults aged ≥40 years with
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Risks of deep vein thrombosis, pulmonary embolism, and bleeding after covid-19: nationwide self-controlled cases series and matched cohort study BMJ (IF 93.333) Pub Date : 2022-04-06 Ioannis Katsoularis, Osvaldo Fonseca-Rodríguez, Paddy Farrington, Hanna Jerndal, Erling Häggström Lundevaller, Malin Sund, Krister Lindmark, Anne-Marie Fors Connolly
Objective To quantify the risk of deep vein thrombosis, pulmonary embolism, and bleeding after covid-19. Design Self-controlled case series and matched cohort study. Setting National registries in Sweden. Participants 1 057 174 people who tested positive for SARS-CoV-2 between 1 February 2020 and 25 May 2021 in Sweden, matched on age, sex, and county of residence to 4 076 342 control participants.
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Efficacy of interventions to reduce long term opioid treatment for chronic non-cancer pain: systematic review and meta-analysis BMJ (IF 93.333) Pub Date : 2022-04-04 Nicholas Avery, Amy G McNeilage, Fiona Stanaway, Claire E Ashton-James, Fiona M Blyth, Rebecca Martin, Ali Gholamrezaei, Paul Glare
Objective To review interventions to reduce long term opioid treatment in people with chronic non-cancer pain, considering efficacy on dose reduction and discontinuation, pain, function, quality of life, withdrawal symptoms, substance use, and adverse events. Design Systematic review and meta-analysis of randomised controlled trials and non-randomised studies of interventions. Data sources Medline
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National experience in the first two years of primary human papillomavirus (HPV) cervical screening in an HPV vaccinated population in Australia: observational study BMJ (IF 93.333) Pub Date : 2022-03-30 Megan A Smith, Maddison Sherrah, Farhana Sultana, Philip E Castle, Marc Arbyn, Dorota Gertig, Michael Caruana, C David Wrede, Marion Saville, Karen Canfell
Objective To review the first two years of the primary human papillomavirus (HPV) cervical screening programme in an HPV vaccinated population. Design Observational study. Setting Australia. Participants 3 745 318 women with a primary HPV test between 1 December 2017 and 31 December 2019; most women aged <40 years had previously been offered vaccination against HPV16 and HPV18. Interventions Primary
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Association of computed tomography screening with lung cancer stage shift and survival in the United States: quasi-experimental study BMJ (IF 93.333) Pub Date : 2022-03-30 Alexandra L Potter, Allison L Rosenstein, Mathew V Kiang, Shivani A Shah, Henning A Gaissert, David C Chang, Florian J Fintelmann, Chi-Fu Jeffrey Yang
Objective To determine the effect of the introduction of low dose computed tomography screening in 2013 on lung cancer stage shift, survival, and disparities in the stage of lung cancer diagnosed in the United States. Design Quasi-experimental study using Joinpoint modeling, multivariable ordinal logistic regression, and multivariable Cox proportional hazards modeling. Setting US National Cancer Database
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Psychological interventions for chronic, non-specific low back pain: systematic review with network meta-analysis BMJ (IF 93.333) Pub Date : 2022-03-30 Emma Kwan-Yee Ho, Lingxiao Chen, Milena Simic, Claire Elizabeth Ashton-James, Josielli Comachio, Daniel Xin Mo Wang, Jill Alison Hayden, Manuela Loureiro Ferreira, Paulo Henrique Ferreira
Objective To determine the comparative effectiveness and safety of psychological interventions for chronic low back pain. Design Systematic review with network meta-analysis. Data sources Medline, Embase, PsycINFO, Cochrane Central Register of Controlled Trials, Web of Science, SCOPUS, and CINAHL from database inception to 31 January 2021. Eligibility criteria for study selection Randomised controlled