Editorial Material
Medicine, General & Internal
David E. Scheim, Colleen Aldous, Barbara Osimani, Edmund J. Fordham, Wendy E. Hoy
Summary: Under certain circumstances, per-protocol (PP) analysis provides a more accurate reflection of the real-world benefits of a medical intervention compared to intention-to-treat (ITT) analysis. Three randomized clinical trials (RCTs) demonstrate the inconsistencies between PP and ITT analysis and highlight the importance of data transparency when discrepancies arise.
JOURNAL OF CLINICAL MEDICINE
(2023)
Article
Health Care Sciences & Services
Mohammod Mostazir, Gordon Taylor, William Edward Henley, Edward Robert Watkins, Rod S. Taylor
Summary: The study aimed to compare treatment effects estimated by ITT and PP methods in RCTs, finding that PP estimates were significantly higher than ITT estimates. PP analysis is not recommended for assessing protocol non-adherence impact in RCTs, and alternative causality-based methods like CACE should be considered.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2021)
Article
Health Care Sciences & Services
Anthony D. Bai, Adam S. Komorowski, Carson K. L. Lo, Pranav Tandon, Xena X. Li, Vaibhav Mokashi, Anna Cvetkovic, Aidan Findlater, Laurel Liang, George Tomlinson, Mark Loeb, Dominik Mertz
Summary: Contrary to common belief, ITT analysis was found to be more conservative than PP analysis in the majority of antibiotic non-inferiority trials, with a larger variance and wider confidence intervals. This finding suggests that ITT analysis should be considered as a mandatory analysis method in non-inferiority trials.
BMC MEDICAL RESEARCH METHODOLOGY
(2021)
Article
Cardiac & Cardiovascular Systems
Anthony P. Carnicelli, Anne S. Hellkamp, Kenneth W. Mahaffey, Daniel E. Singer, Gunter Breithardt, Jonathan L. Halperin, Graeme J. Hankey, Jonathan P. Piccini, Richard C. Becker, Christopher C. Nessel, Scott D. Berkowitz, Keith A. A. Fox, Robert M. Califf, Manesh R. Patel
Summary: This study compared the effect of tracking primary efficacy events in the per-protocol cohort and the intention-to-treat cohort using data from the ROCKET AF trial. It was found that clinical trial termination based on event accrual in the ITT cohort versus the per-protocol cohort may have important implications on trial results depending on rates of study drug discontinuation and event rates off treatment.
JOURNAL OF THE AMERICAN HEART ASSOCIATION
(2021)
Article
Environmental Sciences
Josiane Ferreira Pires, Dimitri Campos Viana, Roberto Alves J. R. Braga, Rosane Freitas Schwan, Cristina Ferreira Silva
Summary: The study revealed that the use of a mixed microbial consortium for treating coffee processing wastewater can effectively decrease pollutant levels, reduce biochemical oxygen demand and chemical oxygen demand, lower phosphorus and nitrogen content, and adjust the pH of the wastewater. Experimental results demonstrated that the microbial inoculum was efficient in treating wastewater from different sources with varying chemical characteristics.
JOURNAL OF ENVIRONMENTAL MANAGEMENT
(2021)
Article
Nutrition & Dietetics
Katarina Forkmann, Lena Roth, Nora Mehl
Summary: While the prevalence of overweight and obesity increases annually, the accessibility of on-site treatment programs does not follow suit. Digital obesity treatment programs like zanadio could potentially alleviate this situation. By providing a digital, multimodal weight reduction program, zanadio meets the demand for obesity treatment and has the potential to fill the gap in obesity care.
Article
Cardiac & Cardiovascular Systems
Felice Gragnano, Marcel Zwahlen, Pascal Vranckx, Dik Heg, Kurt Schmidlin, Christian Hamm, Philippe Gabriel Steg, Giuseppe Gargiulo, Eugene P. McFadden, Yoshinobu Onuma, Ply Chichareon, Edouard Benit, Helge Mollmann, Luc Janssens, Sergio Leonardi, Aleksander Zurakowski, Alessio Arrivi, Robert Jan van Geuns, Kurt Huber, Ton Slagboom, Paolo Calabro, Patrick W. Serruys, Peter Juni, Marco Valgimigli, Stephan Windecker
Summary: The reanalysis of the GLOBAL LEADERS trial showed that ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1-year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting in patients who complied with the study protocol.
JOURNAL OF THE AMERICAN HEART ASSOCIATION
(2022)
Article
Critical Care Medicine
Ignacio E. Tapia, Justine Shults, Christopher M. Cielo, Andrea B. Kelly, Lisa M. Elden, Jonathan M. Spergel, Ruth M. Bradford, Mary Anne Cornaglia, Laura M. Sterni, Jerilynn Radcliffe
Summary: This study found that treatment with INCS did not result in significant improvements in polysomnography, neurobehavioral outcomes, or symptoms in children with OSAS at both 3 and 12 months of treatment.
Article
Engineering, Environmental
Sun-A An, Jonghun Lee, Jeonghoo Sim, Cheol-Gyu Park, Jin-San Lee, Hojung Rho, Kwang-Duck Park, Han-Seung Kim, Yun Chul Woo
Summary: This study evaluated the filtration performance and energy consumption of three different reverse osmosis membranes for treating semiconductor wastewater. The results showed that ESPA2-LD membrane had the best performance in terms of water quality stability and energy consumption.
PROCESS SAFETY AND ENVIRONMENTAL PROTECTION
(2022)
Review
Oncology
Ghulam Rehman Mohyuddin, Tahani Atieh, Nausheen Ahmed, Douglas Sborov, Brian McClune, Al-Ola Abdallah, Aaron M. Goodman, Muhammad Aziz, Isabel Allen, Vinay Prasad
Summary: Chimeric antigen receptor T-cell therapy (CART) has revolutionized the treatment of hematological malignancies. However, the current reporting methodology using modified intention-to-treat analysis (mITT) tends to overestimate efficacy. Through meta-analysis of CD19 and B-cell maturation antigen (BCMA) CART trials, it was found that there is a difference of up to 8-12% in the overall response rate (ORR) between modified and intention-to-treat (iTT) analyses, with limited information on reasons for patients not receiving intended study treatment.
EUROPEAN JOURNAL OF CANCER
(2021)
Article
Immunology
Hongtao Guo, Li Li, Bin Liu, Peipei Lu, Zhiwen Cao, Xinyu Ji, Guilin Ouyang, Zhixin Nie, Aiping Lyu, Cheng Lu
Summary: Difficult-to-treat rheumatoid arthritis (D2T RA) has become a major concern for rheumatologists due to its poor treatment response and persistent symptoms. The unclear causes and lack of data make it difficult to meet the therapeutic demands of D2T RA patients. This review discusses the challenges associated with disease-modifying antirheumatic drugs (DMARDs) and explores factors contributing to inappropriate response and immunological dysregulation in D2T RA.
INTERNATIONAL IMMUNOPHARMACOLOGY
(2023)
Article
Medicine, General & Internal
Abby Mosedale, Delia Hendrie, Elizabeth Geelhoed, Yvonne Zurynski, Suzanne Robinson
Summary: This article presents a realist evaluation protocol for a research translation funding programme, aiming to understand how the research translation process contributes to health system sustainability and value-based healthcare.
Article
Medicine, General & Internal
Grace M. Turner, Rachael Jones, Phillip Collis, Smitaa Patel, Sue Jowett, Sarah Tearne, Robbie Foy, Lou Atkins, Jonathan Mant, Melanie Calvert
Summary: This article introduces a feasibility study and process evaluation of an intervention to support people after TIA/minor stroke. The study aims to assess the feasibility and acceptability of the intervention and the trial procedures for a future randomized controlled trial of this intervention.
Review
Medicine, Research & Experimental
Se-Jin Lee
Summary: Since the discovery of myostatin as a critical regulator of skeletal muscle mass in 1997, efforts have been made to understand its activity mechanisms and develop drugs for treating muscle loss. Significant progress has been made in studying MSTN signaling, along with the development of various biologics tested in clinical trials.
JOURNAL OF CLINICAL INVESTIGATION
(2021)
Article
Multidisciplinary Sciences
Kate E. Mooney, Tracey Bywater, Sebastian Hinde, Gerry Richardson, John Wright, Josie Dickerson, Sarah L. Blower
Summary: Child behavioural and mental health problems have significant impacts on individuals, families, and society. Early intervention through parenting programmes can reduce these problems, but previous studies have lacked diversity in ethnicity and socioeconomic status. This study aims to evaluate the effectiveness of the Incredible Years Toddler parent programme in a diverse population in Bradford, England, and investigate potential moderators.