Article
Dermatology
Sairekha Ravichandran, Kathleen M. Mulligan, Harib H. Ezaldein, Jeffrey F. Scott
Summary: This study aimed to estimate the degree of publication bias for clinical trials supporting FDA approval of new dermatologic drugs. The study found that over the past 15 years, there was no measurable publication bias for efficacy trials supporting new drug approvals in dermatology.
ARCHIVES OF DERMATOLOGICAL RESEARCH
(2023)
Letter
Medicine, General & Internal
Mark P. Lythgoe, Paul Middleton
Summary: This qualitative improvement study examines COVID-19 vaccine approvals by medicine regulatory agencies in the US, EU, and Canada, comparing regulatory review times and analyzing clinical evidence supporting authorization.
Review
Medicine, General & Internal
Asger S. Paludan-Muller, Perrine Crequit, Isabelle Boutron
Summary: An assessment of the completeness of harm reporting in clinical study reports, clinical trial registries, and journal publications for oncological clinical trials revealed that harms were more frequently and comprehensively reported in clinical study reports compared to other sources. Discrepancies in reported harm data and delays in accessing results were identified across the three sources, highlighting the importance of using clinical study reports as the primary data source for systematic reviews on oncological treatments.
Article
Medicine, General & Internal
Stephanie Knippschild, Jeremias Loddenkemper, Sabrina Tulka, Christine Loddenkemper, Christine Baulig
Summary: The study evaluated the adherence to reporting guidelines in RCT abstracts, finding a median of 50% compliance with the 16 CONSORT criteria and 43% complete implementation of the criteria. Additionally, the study revealed that word count had a significant impact on the reporting of CONSORT criteria in abstracts.
Article
Public, Environmental & Occupational Health
Elizabeth E. Roughead, Mhairi Kerr, Anna Moffat, Gizat M. Kassie, Nicole Pratt
Summary: This study consolidates evidence on the risks associated with medicines and acute kidney injury, highlighting the need for cautious use and close monitoring of specific medications in primary care settings.
Review
Oncology
Catherine Lau, George Dranitsaris
Summary: This article examines reimbursement recommendations by the Canadian Agency for Drugs and Technology in Health (CADTH) on oncology drugs approved between 2019 and 2021. CADTH granted positive funding recommendations to all 11 drugs that had priority review approvals, while 2 of the 17 drugs with standard reviews did not submit to CADTH and 3 received negative recommendations.
Article
Economics
Daniela Moye-Holz, S. Vogler
Summary: This study compares the prices and affordability of cancer medicines in Europe and Latin America. The results show that prices vary significantly between countries, and most medicines are considered unaffordable in both regions. This highlights the need for stronger pricing policies to ensure affordable cancer treatment.
APPLIED HEALTH ECONOMICS AND HEALTH POLICY
(2022)
Article
Health Care Sciences & Services
Christopher W. Jones, Amanda C. Adams, Elizabeth Murphy, Rachel P. King, Benjamin Saracco, Karen R. Stesis, Susan Cavanaugh, Brian W. Roberts, Timothy F. Platts-Mills
Summary: Very few trials conducted during prior pandemic events met established standards for the timely public dissemination of trial results.
BMC MEDICAL RESEARCH METHODOLOGY
(2021)
Review
Clinical Neurology
Mohshin Syed, Helena Martin, Emily S. Sena, Paula R. Williamson, Rustam Al-Shahi Salman
Summary: This study investigated the prevalence of outcome reporting bias (ORB) in randomized controlled trials (RCTs) involving patients with stroke or transient ischemic attack (TIA). The study found that the prevalence of ORB in primary outcomes was low in RCTs included in Cochrane reviews.
EUROPEAN STROKE JOURNAL
(2023)
Article
Health Care Sciences & Services
Ashleigh Cara Stewart, Reece Cossar, Shelley Walker, Anna Lee Wilkinson, Brendan Quinn, Paul Dietze, Rebecca Winter, Amy Kirwan, Michael Curtis, James R. P. Ogloff, Stuart Kinner, Campbell Aitken, Tony Butler, Emma Woods, Mark Stoove
Summary: The study found that it is crucial to maintain the integrity of participant data when studying people released from custodial settings, and employing a variety of strategies and measures can minimize the issue of loss to follow-up.
BMC MEDICAL RESEARCH METHODOLOGY
(2021)
Article
Public, Environmental & Occupational Health
Jessi Hanson-DeFusco, Min Shi, Zoe Du, Ornheilia Zounon, Fidele Marc Hounnouvi, Albert Defusco
Summary: Recent case studies show that the Ebola outbreak from 2014-2016 helped some nations prepare for the COVID-19 pandemic. However, there is no known study that assesses how many WHO nations learned from the West African crisis and to what extent.
GLOBALIZATION AND HEALTH
(2023)
Article
Law
Maria Hurtado Beneto
Summary: The CJEU judgment determines that a university hospital is exempt from being classified as a pharmaceutical company, even if it houses a drug production unit. Therefore, the employment of two experts at the university hospital does not amount to a conflict of interest.
REVISTA GENERAL DE DERECHO EUROPEO
(2023)
Review
Anesthesiology
Maj-Brit Norregaard Kjaer, Martin Bruun Madsen, Nick Meier, Anders Granholm, Morten Hylander Moller, Ingrid Egerod, Anders Perner
Summary: A systematic review and meta-analysis of intensive care trials revealed a high proportion of missing health-related quality of life (HRQoL) data among survivors and a high mortality rate at follow-up. The reporting and statistical handling of these issues were insufficient.
ACTA ANAESTHESIOLOGICA SCANDINAVICA
(2023)
Article
Primary Health Care
Karine Buchet-Poyau, Pauline Occelli, Sandrine Touzet, Carole Langlois-Jacques, Sophie Figon, Jean-Pierre Dubois, Antoine Duclos, Marc Chaneliere, Cyrille Colin, Muriel Rabilloud, Maud Keriel-Gascou
Summary: This study demonstrates that providing patients treated with antihypertensive drugs with a booklet to improve communication and interaction with their general practitioners can significantly increase the reporting of adverse drug events to the practitioners, and improve patient satisfaction with communication and high blood pressure management.
BMC FAMILY PRACTICE
(2021)
Article
Behavioral Sciences
Vinaya Hari, Anushree Bose, Vani Holebasavanahalli Thimmashetty, Rujuta Parlikar, Vanteemar S. Sreeraj, Ganesan Venkatasubramanian
Summary: This study aimed to investigate the roles of self-bias effect and intentional binding effect in the auditory context, and to manipulate the activity of the left temporoparietal junction (l-TPJ) with neuromodulation to explore their potential effects. Results showed that neuromodulation of l-TPJ affected the processing of other-labelled tone, and retrospective intentional binding effect was observed in the baseline and anodal-HD-tDCS conditions.
Article
Respiratory System
Osama Mahmoud, Raquel Granell, Gabriela P. Peralta, Judith Garcia-Aymerich, Deborah Jarvis, John Henderson, Jonathan Sterne
Summary: This study found that maternal perinatal BMI, birthweight, childhood lean and fat mass, and early-onset asthma were the most important factors influencing lung function in early adulthood.
EUROPEAN RESPIRATORY JOURNAL
(2023)
Article
Medicine, General & Internal
Edward P. K. Parker, John Tazare, William J. Hulme, Christopher Bates, Edward J. Carr, Jonathan Cockburn, Helen J. Curtis, Louis Fisher, Amelia C. A. Green, Sam Harper, Frank Hester, Elsie M. F. Horne, Fiona Loud, Susan Lyon, Viyaasan Mahalingasivam, Amir Mehrkar, Linda Nab, John Parry, Shalini Santhakumaran, Retha Steenkamp, Jonathan A. C. Sterne, Alex J. Walker, Elizabeth J. Williamson, Michelle Willicombe, Bang Zheng, Ben Goldacre, Dorothea Nitsch, Laurie A. Tomlinson
Summary: This retrospective cohort study aimed to identify factors associated with COVID-19 vaccine uptake among people with kidney disease in England. The study found that although most individuals received the COVID-19 vaccine, there were disparities in vaccine uptake among different clinical and demographic groups, and the coverage of complete vaccine doses was suboptimal.
Editorial Material
Medicine, General & Internal
Kevin B. Knopf, Bishal Gyawali
Article
Medicine, General & Internal
Arushi Sachdev, Isobel Sharpe, Meghan Bowman, Christopher M. Booth, Bishal Gyawali
Summary: This study provides a pooled placebo response rate from drug trials in advanced solid tumors. The results show that about 1% of patients can expect to achieve some response even in the absence of treatment, but complete regression without treatment is extremely rare, almost zero percent. This information is important for patients in their treatment decisions and regulators evaluating the efficacy of cancer drugs based on response rates alone.
Review
Medicine, General & Internal
Lauren L. O'Mahoney, Ash Routen, Clare Gillies, Winifred Ekezie, Anneka Welford, Alexa Zhang, Urvi Karamchandani, Nikita Simms-Williams, Shabana Cassambai, Ashkon Ardavani, Thomas J. Wilkinson, Grace Hawthorne, Ffion Curtis, Andrew P. Kingsnorth, Abdullah Almaqhawi, Thomas Ward, Daniel Ayoubkhani, Amitava Banerjee, Melanie Calvert, Roz Shafran, Terence Stephenson, Jonathan Sterne, Helen Ward, Rachael A. Evans, Francesco Zaccardi, Shaney Wright, Kamlesh Khunti
Summary: This study systematically synthesized global evidence on the prevalence of persistent symptoms in a general post COVID-19 population. The findings show that regardless of hospitalization status, at least 45% of COVID-19 survivors experience unresolved symptoms for about 4 months. The current understanding of Long Covid is limited by heterogeneous study design, follow-up durations, and measurement methods, hindering effective treatment and management strategies.
Article
Medicine, General & Internal
William J. Hulme, Elizabeth Williamson, Elsie M. F. Horne, Amelia Green, Helen I. I. McDonald, Alex J. J. Walker, Helen J. J. Curtis, Caroline E. Morton, Brian MacKenna, Richard Croker, Amir Mehrkar, Seb Bacon, David Evans, Peter Inglesby, Simon Davy, Krishnan Bhaskaran, Anna Schultze, Christopher T. Rentsch, Laurie Tomlinson, Ian J. Douglas, Stephen J. W. Evans, Liam Smeeth, Tom Palmer, Ben Goldacre, Miguel A. Hernan, Jonathan A. C. Sterne
Summary: The COVID-19 vaccines were developed and evaluated through randomized trials, but important questions remain unanswered. Observational studies and target trial emulation can provide valuable insights, although potential biases need to be managed. This article presents two approaches to emulate target trials using observational data.
ANNALS OF INTERNAL MEDICINE
(2023)
Correction
Health Care Sciences & Services
Simon M. Collin, Esther Crawley, Margaret T. May, Jonathan A. C. Sterne, William Hollingworth
BMC HEALTH SERVICES RESEARCH
(2023)
Article
Immunology
Suzanne M. Ingle, Jose M. Miro, Margaret T. May, Lauren E. Cain, Christine Schwimmer, Robert Zangerle, Helen Sambatakou, Charles Cazanave, Peter Reiss, Vanessa Brandes, Heiner C. Bucher, Caroline Sabin, Francesc Vidal, Niels Obel, Amanda Mocroft, Linda Wittkop, Antonella d'Arminio Monforte, Carlo Torti, Cristina Mussini, Hansjakob Furrer, Deborah Konopnicki, Ramon Teira, Michael S. Saag, Heidi M. Crane, Richard D. Moore, Jeffrey M. Jacobson, W. Chris Mathews, Elvin Geng, Joseph J. Eron, Keri N. Althoff, Abigail Kroch, Raynell Lang, M. John Gill, Jonathan A. C. Sterne
Summary: This study aimed to investigate the impact of the timing of antiretroviral therapy (ART) initiation on mortality rates among patients with HIV and cryptococcal meningitis in high-income settings. The study found little evidence to suggest that early ART was associated with higher mortality rates in high-income settings.
CLINICAL INFECTIOUS DISEASES
(2023)
Review
Oncology
Mufiza Farid-Kapadia, Madelyn Barton, Zoe Bider-Canfield, Parneet K. Cheema, Bishal Gyawali, Natalie M. Nightingale, Lidija Latifovic, Henry J. Conter
Summary: For BRAF-altered advanced cancers, tumor-agnostic trials do not yield significantly different results from tumor-specific trials and may offer a more efficient method for evaluating efficacy across multiple tumor types simultaneously, with less heterogeneity between studies.
Letter
Medicine, General & Internal
Bishal Gyawali
Letter
Public, Environmental & Occupational Health
Elsie M. F. Horne, William J. Hulme, Ruth H. Keogh, Tom M. Palmer, Elizabeth J. Williamson, Edward P. K. Parker, Venexia M. Walker, Rochelle Knight, Yinghui Wei, Kurt Taylor, Louis Fisher, Jessica Morley, Amir Mehrkar, Iain Dillingham, Sebastian Bacon, Ben Goldacre, Jonathan A. C. Sterne
Summary: Understanding how the effectiveness of COVID-19 vaccines changes over time and in response to new variants is crucial for scheduling subsequent doses. Previous research has shown that vaccine effectiveness decreases in a log-linear manner over time and remains consistent across different risk-based subgroups. To further investigate the waning effectiveness beyond 26 weeks and in the era of the Omicron variant, the follow-up period was extended to the earliest of 50 weeks after the second dose or March 31, 2022.
AMERICAN JOURNAL OF EPIDEMIOLOGY
(2023)
Article
Public, Environmental & Occupational Health
Kate Birnie, Charles Tomson, Fergus J. Caskey, Yoav Ben-Shlomo, Dorothea Nitsch, Anna Casula, Eleanor J. Murray, Jonathan A. C. Sterne
Summary: The availability of electronic health records data has provided opportunities to examine the comparative effectiveness of dynamic treatment strategies. However, when dealing with continuous treatments, model checking and monitoring of large weights are essential to accurately estimate treatment effects.
Editorial Material
Oncology
Christopher M. Booth, Elizabeth A. Eisenhauer, Bishal Gyawali, Ian F. Tannock
JOURNAL OF CLINICAL ONCOLOGY
(2023)
Article
Immunology
Tom Loosli, Stefanie Hossmann, Suzanne M. Ingle, Hajra Okhai, Katharina Kusejko, Johannes Mouton, Pantxika Bellecave, Ard van Sighem, Melanie Stecher, Antonella d'Arminio Monforte, M. John Gill, Caroline A. Sabin, Gary Maartens, Huldrych F. Guenthard, Jonathan A. C. Sterne, Richard Lessells, Matthias Egger, Roger D. Kouyos
Summary: This study aimed to investigate the resistance to dolutegravir in HIV-infected individuals. The study found that resistance to dolutegravir was rare, but nucleoside reverse transcriptase inhibitor resistance substantially increased the risk of dolutegravir resistance.
Review
Medicine, General & Internal
Harrison J. Hansford, Aidan G. Cashin, Matthew D. Jones, Sonja A. Swanson, Nazrul Islam, Susan R. G. Douglas, Rodrigo R. N. Rizzo, Jack J. Devonshire, Sam A. Williams, Issa J. Dahabreh, Barbra A. Dickerman, Matthias Egger, Xabier Garcia-Albeniz, Robert M. Golub, Sara Lodi, Margarita Moreno-Betancur, Sallie-Anne Pearson, Sebastian Schneeweiss, Jonathan A. C. Sterne, Melissa K. Sharp, Elizabeth A. Stuart, Miguel A. Hernan, Hopin Lee, James H. Mcauley
Summary: The reporting of observational studies that aim to emulate a target trial is inconsistent, and the development of a reporting guideline may improve the quality of reporting.