Article
Oncology
Michael J. Palmer, Terry Krupa, Harriet Richardson, Michael D. Brundage
Summary: The qualitative research explored factors influencing missing patient reported outcomes (PRO) data through the experiences of Clinical Research Associates (CRAs), revealing competition between PROs for routine clinical care and for randomized controlled trials (RCTs), the benefits and drawbacks of paper and electronic formats, influence of instrument and patient characteristics on missing PRO data, challenges in PRO assessment at disease progression, deficiencies in research infrastructure contributing to missing data, and the importance of building relationships with patients to reduce missing PRO data. The study highlighted a need for field guidance and motivation among CRAs to address these issues and improve data quality in cancer RCTs.
Review
Nutrition & Dietetics
Jorge C. Correia, Ahmed Waqas, Teoh Soo Huat, Karim Gariani, Francois R. Jornayvaz, Alain Golay, Zoltan Pataky
Summary: Therapeutic patient education interventions have been found to significantly improve biomedical and psychosocial outcomes for patients with diabetes mellitus and obesity, with positive effects on blood sugar levels and body weight. These interventions are equally effective when delivered through different modes and delivery agents.
Review
Medicine, General & Internal
Jorge Cesar Correia, Ahmed Waqas, Jean-Philippe Assal, Melanie J. Davies, Florence Somers, Alain Golay, Zoltan Pataky
Summary: Chronic disorders are common and have a significant impact on global health, both physically and psychologically. Therapeutic patient education (TPE) interventions have been shown to effectively improve biomedical and psychological outcomes for various chronic disorders. This review aims to provide quantitative evidence on the content and effective teaching strategies in TPE programs, answering questions about the who, what, and how of these interventions.
FRONTIERS IN MEDICINE
(2023)
Article
Hematology
Azita H. Talasaz, Parham Sadeghipour, Maryam Aghakouchakzadeh, Hessam Kakavand, Hamid Ariannejad, Jean M. Connors, Beverley J. Hunt, Jeffrey S. Berger, Benjamin W. Van Tassell, Saskia Middeldorp, Gregory Piazza, Jeffrey Weitz, Mary Cushman, Gregory Y. H. Lip, Samuel Z. Goldhaber, Behnood Bikdeli
Summary: Studies on antithrombotic agents in COVID-19 patients suggest that traditional medications may not be effective, prompting research on novel agents with anti-inflammatory and antiviral effects to improve patient outcomes.
JOURNAL OF THROMBOSIS AND HAEMOSTASIS
(2021)
Article
Dermatology
Kevin S. Kim, An-Wen Chan, Emilie P. Belley-Cote, Aaron M. Drucker
Summary: Noninferiority trials, which assess the comparability of a new treatment with the standard of care, have increased significantly in publication from 2005 to 2015. These trials differ from superiority trials in various aspects of trial design and have unique considerations.
JOURNAL OF INVESTIGATIVE DERMATOLOGY
(2022)
Article
Medicine, Research & Experimental
Tiago Machado, Beatrice Mainoli, Daniel Caldeira, Joaquim J. Ferreira, Ricardo M. Fernandes
Summary: This study found that the reported frequency of data monitoring committee adoption in pediatric randomized controlled trials was higher than previously reported. The use of data monitoring committees varied across different clinical and trial characteristics, suggesting that they may still be underutilized in pediatric trials. Reporting of this item could be improved.
Article
Urology & Nephrology
Jeremy Wu, Wilson Ho, Laurence Klotz, Morgan Yuan, Jason Y. Lee, Yonah Krakowsky
Summary: The purpose of this study was to analyze the strategies of spin in statistically nonsignificant urology randomized controlled trials and evaluate their severity. The results showed that 76% of the trials had some level of spin, and moderate or high spin severity was found in 21% of the conclusions. Therefore, readers and authors should be aware of common spin strategies when interpreting nonsignificant results and critically appraise the significance of the findings for clinical practice.
JOURNAL OF UROLOGY
(2023)
Article
Sport Sciences
Christian Fugl Hansen, Jonas Jensen, John Brodersen, Volkert Siersma, Jonathan D. Comins, Michael R. Krogsgaard
Summary: The majority of RCTs did not use the most appropriate PROM as the primary outcome, but studies that did were more likely to show significant differences between interventions. The high prevalence of unavailable protocols was surprising.
SCANDINAVIAN JOURNAL OF MEDICINE & SCIENCE IN SPORTS
(2021)
Article
Health Care Sciences & Services
Yan Ren, Yuanjin Zhang, Yulong Jia, Yunxiang Huang, Minghong Yao, Ling Li, Guowei Li, Qianrui Li, Min Yang, Peijing Yan, Yuning Wang, Kang Zou, Xin Sun
Summary: The practice of analyzing repeated measure data in randomized controlled trials (RCTs) needs improvement, with careful planning of primary outcomes and the use of statistically advanced methods warranted.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2022)
Article
Surgery
Jessica Nguyen, Allen Li, Derrick Y. Tam, Thomas L. Forbes
Summary: This study describes the characteristics of spin in statistically nonsignificant randomized controlled trials (RCTs) and highlights the inconsistency between interpretations and results in a large proportion of these trials. The findings emphasize the importance of independent evaluation of study findings and the need to limit the use of spin in study interpretations.
JOURNAL OF VASCULAR SURGERY
(2022)
Review
Nutrition & Dietetics
Inigo Maria Perez-Castillo, Rafael Fernandez-Castillo, Agustin Lasserrot-Cuadrado, Jose Luis Gallo-Vallejo, Ana Maria Rojas-Carvajal, Maria Jose Aguilar-Cordero
Summary: The administration of probiotic microorganisms during pregnancy does not seem to have a significant impact on perinatal outcomes, according to a systematic review and meta-analysis. However, reporting of perinatal outcomes varied greatly across studies, and further research should focus on the specific strains of probiotics and their effects on pregnancy outcomes.
Article
Mathematical & Computational Biology
Adam Kaplan, David Nelson
Summary: Missing outcomes are common in randomized controlled trials (RCTs) and can introduce bias in the analysis. We focus on binary outcomes that are possibly missing not at random. Anticipated response rates can be used to address these missing outcomes, especially when considering successful and unsuccessful treatment outcomes. We present Bayesian pattern-mixture models that incorporate information on response rates to analyze the relationship between a binary outcome and an intervention.
STATISTICS IN MEDICINE
(2023)
Article
Economics
Amy M. Berkman, Karly M. Murphy, Elizabeth J. Siembida, Nancy Lau, Yimin Geng, Susan K. Parsons, John M. Salsman, Michael E. Roth
Summary: The study identified a lack of patient-reported outcomes in therapeutic phase 3 trials for adolescent and young adult cancer patients, with only one trial publishing PRO data. Germ cell tumors and non-Hodgkin lymphoma trials had the highest proportions of PRO inclusion. The use of PRO measures varied and there was no significant change in the proportion of trials including a PRO endpoint between 2007-2013 and 2014-2020.
Review
Health Care Sciences & Services
Margarita Ravinskaya, Jos H. Verbeek, Miranda Langendam, Joost G. Daams, Carel T. J. Hulshof, Ira Madan, Suzanne M. M. Verstappen, Marije Hagendijk, Regina Kunz, Jan L. Hoving
Summary: This study aimed to investigate how work participation outcomes are measured in randomized controlled trials internationally and across disciplines. A total of 269 trials reporting on 435 work participation outcomes from 2014 to 2019 were identified, with outcomes grouped into four main categories: employment status, absence from work, at-work productivity loss, and employability. Extensive variability existed in the measurement methods and instruments used across all categories, highlighting the need for a Core Outcome Set for work participation.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2022)
Review
Public, Environmental & Occupational Health
Qin Zhang, Xiumei Tang, Yanjie Zhao, Zhoufeng Wang
Summary: Our study aimed to identify, appraise, and summarize the effectiveness of team-based learning (TBL) versus lecture-based learning (LBL) in nursing students through a systematic review of randomized controlled trials (RCTs). The results suggested that TBL was effective in improving academic performance and general ability in nursing students. High-quality trials are needed, and standardized outcomes should be used.
FRONTIERS IN PUBLIC HEALTH
(2023)
Article
Computer Science, Interdisciplinary Applications
Guillaume Cabanac, Theodora Oikonomidi, Isabelle Boutron
Summary: Preprints play a vital role in open and rapid communication of non-peer reviewed research, but existing preprint servers have limitations in identifying all preprint-publication links. To address this issue, a more thorough approach is necessary to improve the accuracy of information retrieval tasks related to preprint-publication links.
Review
Medicine, General & Internal
Matthew J. Page, Joanne E. McKenzie, Patrick M. Bossuyt, Isabelle Boutron, Tammy C. Hoffmann, Cynthia D. Mulrow, Larissa Shamseer, Jennifer M. Tetzlaff, Elie A. Akl, Sue E. Brennan, Roger Chou, Julie Glanville, Jeremy M. Grimshaw, Asbjorn Hrobjartsson, Manoj M. Lalu, Tianjing Li, Elizabeth W. Loder, Evan Mayo-Wilson, Steve McDonald, Luke A. McGuinness, Lesley A. Stewart, James Thomas, Andrea C. Tricco, Vivian A. Welch, Penny Whiting, David Moher
Summary: The PRISMA statement was designed to help systematic reviewers transparently report the purpose, methods, and findings of their reviews. The updated PRISMA 2020 statement includes new reporting guidance, a 27-item checklist, an abstract checklist, and revised flow diagrams for reviews.
BMJ-BRITISH MEDICAL JOURNAL
(2021)
Article
Medicine, General & Internal
Matthew J. Page, Joanne E. McKenzie, Patrick M. Bossuyt, Isabelle Boutron, Tammy C. Hoffmann, Cynthia D. Mulrow, Larissa Shamseer, Jennifer M. Tetzlaff, Elie A. Akl, Sue E. Brennan, Roger Chou, Julie Glanville, Jeremy M. Grimshaw, Asbjorn Hrobjartsson, Manoj M. Lalu, Tianjing Li, Elizabeth W. Loder, Evan Mayo-Wilson, Steve McDonald, Luke A. McGuinness, Lesley A. Stewart, James Thomas, Andrea C. Tricco, Vivian A. Welch, Penny Whiting, David Moher
Summary: The article introduces PRISMA 2020, an updated reporting guideline for systematic reviews and meta-analyses.
Article
Health Care Sciences & Services
Olivier Pierre, Carolina Riveros, Sarah Charpy, Isabelle Boutron
Summary: The study assessed the sensitivity of two secondary electronic sources of COVID-19 studies, with the L.OVE platform showing better performance in identifying research reports.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2022)
Article
Health Care Sciences & Services
Astrid Chevance, Axel Fortel, Adeline Jouannin, Faustine Denis, Marie-France Mamzer, Philippe Ravaud, Stephanie Sidorkiewicz
Summary: Digital pills face limitations in prospective acceptability and willingness to use, primarily due to clinical and ethical concerns. Results indicate that willingness to take digital pills is associated with gender and the current use of connected devices to record health settings.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2022)
Article
Health Care Sciences & Services
Van Thu Nguyen, Philippe Ravaud, Viet Thi Tran, Bridget Young, Isabelle Boutron
Summary: The study investigates patients' preferences for the organization of randomized controlled trials (RCTs) and finds that most patients prefer a hybrid model involving both on-site and remote visits. Patients are more likely to participate in a trial organized according to their preferences.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2022)
Article
Health Care Sciences & Services
Tat-Thang Vo, Aidan Cashin, Cecilia Superchi, Pham Hien Trang Tu, Thanh Binh Nguyen, Isabelle Boutron, David MacKinnon, Tyler Vanderweele, Hopin Lee, Stijn Vansteelandt
Summary: The bias assessment practice in recently published systematic reviews of mediation studies is found to be suboptimal, with a lack of consensus, rigorous development, and validation of assessment tools. A consensus-based bias assessment tool specifically designed for mediation studies is needed to improve the quality and consistency of assessments.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2022)
Article
Medicine, General & Internal
Philipp Kapp, Laura Esmail, Lina Ghosn, Philippe Ravaud, Isabelle Boutron
Summary: In the context of the COVID-19 pandemic, this study compared the reporting characteristics of randomized controlled trials (RCTs) between preprints and peer-reviewed publications. The results showed that transparency, completeness, and consistency of reporting of COVID-19 clinical trials were insufficient in both preprints and peer-reviewed publications. There were no major improvements after the journal peer review process.
Editorial Material
Health Care Sciences & Services
Ruth Stewart, Isabelle Boutron, Elie A. Akl
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2023)
Article
Health Care Sciences & Services
Dimitris Mavridis, Adriani Nikolakopoulou, Irini Moustaki, Anna Chaimani, Raphael Porcherd, Isabelle Boutron, Philippe Ravaud
Summary: This study presents graphical methods to group interventions and uses conjoint analysis to place weights on outcomes based on stakeholders' preferences. The results provide valuable information about the clustering of interventions. Grouping interventions helps decision makers identify optimal options in terms of benefit-risk balance and choose interventions from the best cluster based on other factors such as cost and implementation.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2023)
Article
Mathematical & Computational Biology
Theodoros Evrenoglou, Isabelle Boutron, Georgios Seitidis, Lina Ghosn, Anna Chaimani
Summary: Outputs from living evidence syntheses projects have been widely used during the pandemic to provide evidence-based recommendations. However, stakeholders also need to understand the data and perform their own exploratory analyses. To assist them, a metaCOVID application has been created in R to facilitate fast data exploration and tailored sub-analyses.
RESEARCH SYNTHESIS METHODS
(2023)
Article
Health Care Sciences & Services
Mauricia Davidson, Theodoros Evrenoglou, Carolina Grana, Anna Chaimani, Isabelle Boutron
Summary: This study evaluated the difference in summary treatment effect estimates between preprint and peer-reviewed journal trials in the context of COVID-19. The results showed that there was no significant difference in summary effect estimates between preprint and peer-reviewed journal trials.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2023)
Review
Health Care Sciences & Services
Erlend Faltinsen, Adnan Todorovac, Isabelle Boutron, Lesley A. Stewart, Asbjorn Hrobjartsson, Andreas Lundh
Summary: The study compares the contemporary Cochrane review approach with a structured approach for retrieving information on trial funding and researchers' conflicts of interest, and finds that the structured approach is more effective in obtaining this information.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2023)
Article
Dermatology
Laura Fertitta, Kavita Y. Sarin, Christina Bergqvist, Ekshika Patel, Bastien Peiffer, Sabine Moryousef, Marie-Laure Armand, Arnaud Jannic, Salah Ferkal, Philippe Ravaud, Viet-Thi Tran, Jaishri O. Blakeley, Carlos G. Romo, Khaled Ezzedine, Pierre Wolkenstein
Summary: This study first defined severity strata for cutaneous neurofibromas using an anchoring approach. After validation in French and United States populations, the cNF-Skindex and the strata showed a strong correlation in interpreting cutaneous neurofibromas in daily practice and clinical trials.
JOURNAL OF INVESTIGATIVE DERMATOLOGY
(2023)