Articles

The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence

Participation in randomized controlled trials (RCTs) may be quite demanding and could represent an important burden for patients. We aimed to explore this research burden (i.e., the psychological, physical, an...

Authors: Nivantha Naidoo, Van Thu Nguyen, Philippe Ravaud, Bridget Young, Philippe Amiel, Daniel Schanté, Mike Clarke and Isabelle Boutron

Youth Depression Alleviation with Anti-inflammatory Agents (YoDA-A): a randomised clinical trial of rosuvastatin and aspirin

Inflammation contributes to the pathophysiology of major depressive disorder (MDD), and anti-inflammatory strategies might therefore have therapeutic potential. This trial aimed to determine whether adjunctive...

Authors: Michael Berk, Mohammadreza Mohebbi, Olivia M. Dean, Sue M. Cotton, Andrew M. Chanen, Seetal Dodd, Aswin Ratheesh, G. Paul Amminger, Mark Phelan, Amber Weller, Andrew Mackinnon, Francesco Giorlando, Shelley Baird, Lisa Incerti, Rachel E. Brodie, Natalie O. Ferguson…

Pregnancy-specific malarial immunity and risk of malaria in pregnancy and adverse birth outcomes: a systematic review

In endemic areas, pregnant women are highly susceptible to Plasmodium falciparum malaria characterized by the accumulation of parasitized red blood cells (pRBC) in the placenta. In subsequent pregnancies, women d...

Authors: Julia C. Cutts, Paul A. Agius, Zaw Lin, Rosanna Powell, Kerryn Moore, Bridget Draper, Julie A. Simpson and Freya J. I. Fowkes

Can real-world data really replace randomised clinical trials?

Authors: Sreeram V. Ramagopalan, Alex Simpson and Cormac Sammon

Vaccinating children against influenza: overall cost-effective with potential for undesirable outcomes

The present study aims to assess the cost-effectiveness of an influenza vaccination program for children in the Netherlands. This requires an evaluation of the long-term impact of such a program on the burden ...

Authors: Pieter T. de Boer, Jantien A. Backer, Albert Jan van Hoek and Jacco Wallinga

Reductions in sugar sales from soft drinks in the UK from 2015 to 2018

The consumption of free sugars in the UK is more than double the guideline intake for adults and close to triple for children, with soft drinks representing a significant proportion. The aim of this study was ...

Authors: L. K. Bandy, P. Scarborough, R. A. Harrington, M. Rayner and S. A. Jebb

Lifestyle factors and risk of multimorbidity of cancer and cardiometabolic diseases: a multinational cohort study

Although lifestyle factors have been studied in relation to individual non-communicable diseases (NCDs), their association with development of a subsequent NCD, defined as multimorbidity, has been scarcely inv...

Authors: Heinz Freisling, Vivian Viallon, Hannah Lennon, Vincenzo Bagnardi, Cristian Ricci, Adam S. Butterworth, Michael Sweeting, David Muller, Isabelle Romieu, Pauline Bazelle, Marina Kvaskoff, Patrick Arveux, Gianluca Severi, Christina Bamia, Tilman Kühn, Rudolf Kaaks…

‘Optimising’ breastfeeding: what can we learn from evolutionary, comparative and anthropological aspects of lactation?

Promoting breastfeeding is an important public health intervention, with benefits for infants and mothers. Even modest increases in prevalence and duration may yield considerable economic savings. However, des...

Authors: Mary S. Fewtrell, Nurul H. Mohd Shukri and Jonathan C. K. Wells

Mass cytometry analysis reveals a distinct immune environment in peritoneal fluid in endometriosis: a characterisation study

Endometriosis is a gynaecological condition characterised by immune cell infiltration and distinct inflammatory signatures found in the peritoneal cavity. In this study, we aim to characterise the immune micro...

Authors: Manman Guo, Cemsel Bafligil, Thomas Tapmeier, Carol Hubbard, Sanjiv Manek, Catherine Shang, Fernando O. Martinez, Nicole Schmidt, Maik Obendorf, Holger Hess-Stumpp, Thomas M. Zollner, Stephen Kennedy, Christian M. Becker, Krina T. Zondervan, Adam P. Cribbs and Udo Oppermann

Multi-level transcriptome sequencing identifies COL1A1 as a candidate marker in human heart failure progression

Heart failure (HF) has been recognized as a global pandemic with a high rate of hospitalization, morbidity, and mortality. Although numerous advances have been made, its representative molecular signatures rem...

Authors: Xiumeng Hua, Yin-Ying Wang, Peilin Jia, Qing Xiong, Yiqing Hu, Yuan Chang, Songqing Lai, Yong Xu, Zhongming Zhao and Jiangping Song

Drug-resistant enteric fever worldwide, 1990 to 2018: a systematic review and meta-analysis

Antimicrobial resistance (AMR) is an increasing threat to global health. There are > 14 million cases of enteric fever every year and > 135,000 deaths. The disease is primarily controlled by antimicrobial trea...

Authors: Annie J. Browne, Bahar H. Kashef Hamadani, Emmanuelle A. P. Kumaran, Puja Rao, Joshua Longbottom, Eli Harriss, Catrin E. Moore, Susanna Dunachie, Buddha Basnyat, Stephen Baker, Alan D. Lopez, Nicholas P. J. Day, Simon I. Hay and Christiane Dolecek

The NASSS framework for ex post theorisation of technology-supported change in healthcare: worked example of the TORPEDO programme

Evaluation of health technology programmes should be theoretically informed, interdisciplinary, and generate in-depth explanations. The NASSS (non-adoption, abandonment, scale-up, spread, sustainability) frame...

Authors: Seye Abimbola, Bindu Patel, David Peiris, Anushka Patel, Mark Harris, Tim Usherwood and Trisha Greenhalgh

Travel time to health facilities in areas of outbreak potential: maps for guiding local preparedness and response

Repeated outbreaks of emerging pathogens underscore the need for preparedness plans to prevent, detect, and respond. As countries develop and improve National Action Plans for Health Security, addressing subna...

Authors: E. N. Hulland, K. E. Wiens, S. Shirude, J. D. Morgan, A. Bertozzi-Villa, T. H. Farag, N. Fullman, M. U. G. Kraemer, M. K. Miller-Petrie, V. Gupta, R. C. Reiner Jr., P. Rabinowitz, J. N. Wasserheit, B. P. Bell, S. I. Hay, D. J. Weiss…

Suicide prevention and depression apps’ suicide risk assessment and management: a systematic assessment of adherence to clinical guidelines

There are an estimated 800,000 suicides per year globally, and approximately 16,000,000 suicide attempts. Mobile apps may help address the unmet needs of people at risk. We assessed adherence of suicide preven...

Authors: Laura Martinengo, Louise Van Galen, Elaine Lum, Martin Kowalski, Mythily Subramaniam and Josip Car

Calibration: the Achilles heel of predictive analytics

The assessment of calibration performance of risk prediction models based on regression or more flexible machine learning algorithms receives little attention.

Authors: Ben Van Calster, David J. McLernon, Maarten van Smeden, Laure Wynants and Ewout W. Steyerberg

Delirium is prevalent in older hospital inpatients and associated with adverse outcomes: results of a prospective multi-centre study on World Delirium Awareness Day

Delirium is a common severe neuropsychiatric condition secondary to physical illness, which predominantly affects older adults in hospital. Prior to this study, the UK point prevalence of delirium was unknown....

Authors:

Introduction of primary screening using high-risk HPV DNA detection in the Dutch cervical cancer screening programme: a population-based cohort study

In January 2017, the Dutch cervical cancer screening programme transitioned from cytomorphological to primary high-risk HPV (hrHPV) DNA screening, including the introduction of self-sampling, for women aged be...

Authors: Clare A. Aitken, Heleen M. E. van Agt, Albert G. Siebers, Folkert J. van Kemenade, Hubert G. M. Niesters, Willem J. G. Melchers, Judith E. M. Vedder, Rob Schuurman, Adriaan J. C. van den Brule, Hans C. van der Linden, John W. J. Hinrichs, Anco Molijn, Klaas J. Hoogduin, Bettien M. van Hemel and Inge M. C. M. de Kok

Therapeutic effect of nanoliposomal PCSK9 vaccine in a mouse model of atherosclerosis

Proprotein convertase subtilisin/kexin 9 (PCSK9) is an important regulator of low-density lipoprotein receptor (LDLR) and plasma levels of LDL cholesterol (LDL-C). PCSK9 inhibition is an efficient therapeutic ...

Authors: Amir Abbas Momtazi-Borojeni, Mahmoud Reza Jaafari, Ali Badiee, Maciej Banach and Amirhossein Sahebkar

Differential impact of malaria control interventions on P. falciparum and P. vivax infections in young Papua New Guinean children

As malaria transmission declines, understanding the differential impact of intensified control on Plasmodium falciparum relative to Plasmodium vivax and identifying key drivers of ongoing transmission is essentia...

Authors: Maria Ome-Kaius, Johanna Helena Kattenberg, Sophie Zaloumis, Matthew Siba, Benson Kiniboro, Shadrach Jally, Zahra Razook, Daisy Mantila, Desmond Sui, Jason Ginny, Anna Rosanas-Urgell, Stephan Karl, Thomas Obadia, Alyssa Barry, Stephen J. Rogerson, Moses Laman…

The quality of preventive care for pre-school aged children in Australian general practice

Variable and poor care quality are important causes of preventable patient harm. Many patients receive less than recommended care, but the extent of the problem remains largely unknown. The CareTrack Kids (CTK...

Authors: Louise K. Wiles, Carl de Wet, Chris Dalton, Elisabeth Murphy, Mark F. Harris, Peter D. Hibbert, Charlotte J. Molloy, Gaston Arnolda, Hsuen P. Ting and Jeffrey Braithwaite

Determinants of high residual post-PCV13 pneumococcal vaccine-type carriage in Blantyre, Malawi: a modelling study

In November 2011, Malawi introduced the 13-valent pneumococcal conjugate vaccine (PCV13) into the routine infant schedule. Four to 7 years after introduction (2015–2018), rolling prospective nasopharyngeal car...

Authors: J. Lourenço, U. Obolski, T. D. Swarthout, A. Gori, N. Bar-Zeev, D. Everett, A. W. Kamng’ona, T. S. Mwalukomo, A. A. Mataya, C. Mwansambo, M. Banda, S. Gupta, N. French and R. S. Heyderman

Patterns of symptoms before a diagnosis of first episode psychosis: a latent class analysis of UK primary care electronic health records

The nature of symptoms in the prodromal period of first episode psychosis (FEP) remains unclear. The objective was to determine the patterns of symptoms recorded in primary care in the 5 years before FEP diagn...

Authors: Ying Chen, Saeed Farooq, John Edwards, Carolyn A. Chew-Graham, David Shiers, Martin Frisher, Richard Hayward, Athula Sumathipala and Kelvin P. Jordan

Causal association of type 2 diabetes with amyotrophic lateral sclerosis: new evidence from Mendelian randomization using GWAS summary statistics

Associations between type 2 diabetes (T2D) and amyotrophic lateral sclerosis (ALS) were discovered in observational studies in both European and East Asian populations. However, whether such associations are c...

Authors: Ping Zeng, Ting Wang, Junnian Zheng and Xiang Zhou

Regulating digital health technologies with transparency: the case for dynamic and multi-stakeholder evaluation

The prevalence of smartphones today, paired with the increasing precision and therapeutic potential of digital capabilities, offers unprecedented opportunity in the field of digital medicine. Smartphones offer...

Authors: Elena Rodriguez-Villa and John Torous

Adherence to the World Cancer Research Fund/American Institute for Cancer Research cancer prevention recommendations and risk of in situ breast cancer in the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort

Even though in situ breast cancer (BCIS) accounts for a large proportion of the breast cancers diagnosed, few studies have investigated potential risk factors for BCIS. Their results suggest that some establis...

Authors: Nena Karavasiloglou, Anika Hüsing, Giovanna Masala, Carla H. van Gils, Renée Turzanski Fortner, Jenny Chang-Claude, Inge Huybrechts, Elisabete Weiderpass, Marc Gunter, Patrick Arveux, Agnès Fournier, Marina Kvaskoff, Anne Tjønneland, Cecilie Kyrø, Christina C. Dahm, Helene Tilma Vistisen…

Economic analyses to inform public health decision-making for tuberculosis: the role of understanding implementation

Authors: Priya B. Shete and James G. Kahn

Determinants and extent of weight recording in UK primary care: an analysis of 5 million adults’ electronic health records from 2000 to 2017

Excess weight and unexpected weight loss are associated with multiple disease states and increased morbidity and mortality, but weight measurement is not routine in many primary care settings. The aim of this ...

Authors: B. D. Nicholson, P. Aveyard, C. R. Bankhead, W. Hamilton, F. D. R. Hobbs and S. Lay-Flurrie

Insulin resistance and systemic metabolic changes in oral glucose tolerance test in 5340 individuals: an interventional study

Insulin resistance (IR) is predictive for type 2 diabetes and associated with various metabolic abnormalities in fasting conditions. However, limited data are available on how IR affects metabolic responses in...

Authors: Qin Wang, Jari Jokelainen, Juha Auvinen, Katri Puukka, Sirkka Keinänen-Kiukaanniemi, Marjo-Riitta Järvelin, Johannes Kettunen, Ville-Petteri Mäkinen and Mika Ala-Korpela

In utero exposure to mercury and childhood overweight or obesity: counteracting effect of maternal folate status

Low-dose mercury (Hg) exposure has been associated with cardiovascular diseases, diabetes, and obesity in adults, but it is unknown the metabolic consequence of in utero Hg exposure. This study aimed to invest...

Authors: Guoying Wang, Jessica DiBari, Eric Bind, Andrew M. Steffens, Jhindan Mukherjee, Tami R. Bartell, David C. Bellinger, Xiumei Hong, Yuelong Ji, Mei-Cheng Wang, Marsha Wills-Karp, Tina L. Cheng and Xiaobin Wang

Can public health policies on alcohol and tobacco reduce a cancer epidemic? Australia's experience

Although long-term alcohol and tobacco use have widely been recognised as important risk factors for cancer, the impacts of alcohol and tobacco health policies on cancer mortality have not been examined in pre...

Authors: Heng Jiang, Michael Livingston, Robin Room, Yong Gan, Dallas English and Richard Chenhall

Engagement, not personal characteristics, was associated with the seriousness of regulatory adjudication decisions about physicians: a cross-sectional study

Outcomes of processes questioning a physician’s ability to practise —e.g. disciplinary or regulatory— may strongly impact their career and provided care. However, it is unclear what factors relate systematical...

Authors: Javier A. Caballero and Steve P. Brown

Challenges in management and prevention of ischemic heart disease in low socioeconomic status people in LLMICs

Cardiovascular diseases, principally ischemic heart disease (IHD), are the most important cause of death and disability in the majority of low- and lower-middle-income countries (LLMICs). In these countries, I...

Authors: Rajeev Gupta and Salim Yusuf

Body composition of children with moderate and severe undernutrition and after treatment: a narrative review

Until recently, undernourished children were usually assessed using simple anthropometric measurements, which provide global assessments of nutritional status. There is increasing interest in obtaining more di...

Authors: Jonathan C. K. Wells

Determinants of linear growth faltering among children with moderate-to-severe diarrhea in the Global Enteric Multicenter Study

Moderate-to-severe diarrhea (MSD) in the first 2 years of life can impair linear growth. We sought to determine risk factors for linear growth faltering and to build a clinical prediction tool to identify chil...

Authors: Rebecca L. Brander, Patricia B. Pavlinac, Judd L. Walson, Grace C. John-Stewart, Marcia R. Weaver, Abu S. G. Faruque, Anita K. M. Zaidi, Dipika Sur, Samba O. Sow, M. Jahangir Hossain, Pedro L. Alonso, Robert F. Breiman, Dilruba Nasrin, James P. Nataro, Myron M. Levine and Karen L. Kotloff

The epidemiological burden of obesity in childhood: a worldwide epidemic requiring urgent action

In recent decades, the prevalence of obesity in children has increased dramatically. This worldwide epidemic has important consequences, including psychiatric, psychological and psychosocial disorders in child...

Authors: Mariachiara Di Cesare, Maroje Sorić, Pascal Bovet, J Jaime Miranda, Zulfiqar Bhutta, Gretchen A Stevens, Avula Laxmaiah, Andre-Pascal Kengne and James Bentham

Tackling the triple threats of childhood malnutrition

The term ‘double burden of malnutrition’ is usually interpreted in terms of the physical status of children: stunted and wasted children on the one hand and overweight/obese children on the other. There is a t...

Authors: Martha Mwangome and Andrew M. Prentice

Growth faltering is associated with altered brain functional connectivity and cognitive outcomes in urban Bangladeshi children exposed to early adversity

Stunting affects more than 161 million children worldwide and can compromise cognitive development beginning early in childhood. There is a paucity of research using neuroimaging tools in conjunction with sens...

Authors: Wanze Xie, Sarah K. G. Jensen, Mark Wade, Swapna Kumar, Alissa Westerlund, Shahria H. Kakon, Rashidul Haque, William A. Petri and Charles A. Nelson

Environmental enteric dysfunction: a review of potential mechanisms, consequences and management strategies

Environmental enteric dysfunction (EED) is an acquired enteropathy of the small intestine, characterized by enteric inflammation, villus blunting and decreased crypt-to-villus ratio. EED has been associated wi...

Authors: Kirkby D. Tickell, Hannah E. Atlas and Judd L. Walson

Profiling Mycobacterium tuberculosis transmission and the resulting disease burden in the five highest tuberculosis burden countries

Tuberculosis (TB) control efforts are hampered by an imperfect understanding of TB epidemiology. The true age distribution of disease is unknown because a large proportion of individuals with active TB remain ...

Authors: Romain Ragonnet, James M. Trauer, Nicholas Geard, Nick Scott and Emma S. McBryde

Validation of the AJCC prognostic stage for HER2-positive breast cancer in the ShortHER trial

The 8th edition of the American Joint Committee on Cancer (AJCC) staging has introduced prognostic stage based on anatomic stage combined with biologic factors. We aimed to validate the prognostic stage in HER...

Authors: Maria Vittoria Dieci, Giancarlo Bisagni, Alba A. Brandes, Antonio Frassoldati, Luigi Cavanna, Francesco Giotta, Michele Aieta, Vittorio Gebbia, Antonino Musolino, Ornella Garrone, Michela Donadio, Anita Rimanti, Alessandra Beano, Claudio Zamagni, Hector Soto Parra, Federico Piacentini…

Bleeding in cardiac patients prescribed antithrombotic drugs: electronic health record phenotyping algorithms, incidence, trends and prognosis

Clinical guidelines and public health authorities lack recommendations on scalable approaches to defining and monitoring the occurrence and severity of bleeding in populations prescribed antithrombotic therapy.

Authors: Laura Pasea, Sheng-Chia Chung, Mar Pujades-Rodriguez, Anoop D. Shah, Samantha Alvarez-Madrazo, Victoria Allan, James T. Teo, Daniel Bean, Reecha Sofat, Richard Dobson, Amitava Banerjee, Riyaz S. Patel, Adam Timmis, Spiros Denaxas and Harry Hemingway

Accuracy in detecting inadequate research reporting by early career peer reviewers using an online CONSORT-based peer-review tool (COBPeer) versus the usual peer-review process: a cross-sectional diagnostic study

The peer review process has been questioned as it may fail to allow the publication of high-quality articles. This study aimed to evaluate the accuracy in identifying inadequate reporting in RCT reports by ear...

Authors: Anthony Chauvin, Philippe Ravaud, David Moher, David Schriger, Sally Hopewell, Daniel Shanahan, Sabina Alam, Gabriel Baron, Jean-Philippe Regnaux, Perrine Crequit, Valeria Martinez, Carolina Riveros, Laurence Le Cleach, Alessandro Recchioni, Douglas G. Altman and Isabelle Boutron

NG2 glia regulate brain innate immunity via TGF-β2/TGFBR2 axis

Brain innate immunity is vital for maintaining normal brain functions. Immune homeostatic imbalances play pivotal roles in the pathogenesis of neurological diseases including Parkinson’s disease (PD). However,...

Authors: Shu-zhen Zhang, Qin-qin Wang, Qiao-qiao Yang, Huan-yu Gu, Yan-qing Yin, Yan-dong Li, Jin-can Hou, Rong Chen, Qing-qing Sun, Ying-feng Sun, Gang Hu and Jia-wei Zhou

Unravelling the complex nature of resilience factors and their changes between early and later adolescence

Childhood adversity (CA) is strongly associated with mental health problems. Resilience factors (RFs) reduce mental health problems following CA. Yet, knowledge on the nature of RFs is scarce. Therefore, we ex...

Authors: J. Fritz, J. Stochl, E. I. Fried, I. M. Goodyer, C. D. van Borkulo, P. O. Wilkinson and A.-L. van Harmelen

Live birth rates and perinatal outcomes when all embryos are frozen compared with conventional fresh and frozen embryo transfer: a cohort study of 337,148 in vitro fertilisation cycles

It is not known whether segmentation of an in vitro fertilisation (IVF) cycle, with freezing of all embryos prior to transfer, increases the chance of a live birth after all embryos are transferred.

Authors: Andrew D. A. C. Smith, Kate Tilling, Deborah A. Lawlor and Scott M. Nelson

Representation of people with comorbidity and multimorbidity in clinical trials of novel drug therapies: an individual-level participant data analysis

Clinicians are less likely to prescribe guideline-recommended treatments to people with multimorbidity than to people with a single condition. Doubts as to the applicability of clinical trials of drug treatmen...

Authors: Peter Hanlon, Laurie Hannigan, Jesus Rodriguez-Perez, Colin Fischbacher, Nicky J. Welton, Sofia Dias, Frances S. Mair, Bruce Guthrie, Sarah Wild and David A. McAllister

Synthetic high-density lipoprotein nanoparticles for the treatment of Niemann–Pick diseases

Niemann–Pick disease type C is a fatal and progressive neurodegenerative disorder characterized by the accumulation of unesterified cholesterol in late endosomes and lysosomes. We sought to develop new therape...

Authors: Mark L. Schultz, Maria V. Fawaz, Ruth D. Azaria, Todd C. Hollon, Elaine A. Liu, Thaddeus J. Kunkel, Troy A. Halseth, Kelsey L. Krus, Ran Ming, Emily E. Morin, Hayley S. McLoughlin, David D. Bushart, Henry L. Paulson, Vikram G. Shakkottai, Daniel A. Orringer, Anna S. Schwendeman…

Aspirin for primary prevention of cardiovascular disease: a meta-analysis with a particular focus on subgroups

The role of aspirin in primary prevention of cardiovascular disease (CVD) remains unclear. We aimed to investigate the benefit-risk ratio of aspirin for primary prevention of CVD with a particular focus on sub...

Authors: Georg Gelbenegger, Marek Postula, Ladislav Pecen, Sigrun Halvorsen, Maciej Lesiak, Christian Schoergenhofer, Bernd Jilma, Christian Hengstenberg and Jolanta M. Siller-Matula

Does low-density lipoprotein cholesterol induce inflammation? If so, does it matter? Current insights and future perspectives for novel therapies

Dyslipidemia and inflammation are closely interrelated contributors in the pathogenesis of atherosclerosis. Disorders of lipid metabolism initiate an inflammatory and immune-mediated response in atherosclerosi...

Authors: Ruurt A. Jukema, Tarek A. N. Ahmed and Jean-Claude Tardif

Effect of continued folic acid supplementation beyond the first trimester of pregnancy on cognitive performance in the child: a follow-up study from a randomized controlled trial (FASSTT Offspring Trial)

Periconceptional folic acid prevents neural tube defects (NTDs), but it is uncertain whether there are benefits for offspring neurodevelopment arising from continued maternal folic acid supplementation beyond ...

Authors: Helene McNulty, Mark Rollins, Tony Cassidy, Aoife Caffrey, Barry Marshall, James Dornan, Marian McLaughlin, Breige A. McNulty, Mary Ward, J. J. Strain, Anne M. Molloy, Diane J. Lees-Murdock, Colum P. Walsh and Kristina Pentieva