Review
Medicine, General & Internal
Lindsay M. Gorrell, Benjamin T. Brown, Roger Engel, Reidar P. Lystad
Summary: This study aims to investigate whether there has been a change in the reporting of adverse events associated with spinal manipulation in recent years. The systematic literature review found that although the reporting of adverse events has increased, the overall reporting level remains low and inconsistent with established standards.
Review
Psychology, Clinical
Tanguy Taillefer de Laportaliere, Adeline Jullien, Antoine Yrondi, Philippe Cestac, Francois Montastruc
Summary: This study found that the reporting quality of adverse events (AEs) in clinical trials of esketamine was poor, with fewer AEs reported in journal articles compared to the data in ClinicalTrial.gov. The study suggests that the assessment of the benefits/risks balance of esketamine based on trial publications is flawed due to the poor accuracy and completeness of harm data.
PSYCHOLOGICAL MEDICINE
(2023)
Review
Immunology
Shirin Heidari, Alice Palmer-Ross, Tracey Goodman
Summary: The systematic review of COVID-19 vaccine trials reveals a lack of reporting and discussion on sex and gender differences, which could have implications for adverse events and vaccine hesitancy. Ensuring that clinical research on vaccines adequately considers sex and gender is crucial for recovery from the COVID-19 pandemic and broader public health efforts.
Article
Medicine, General & Internal
Ghulam Rehman Mohyuddin, Kelly Koehn, Al-Ola Abdallah, Aaron M. Goodman, Vinay Prasad
Summary: This systematic review found that less than half of multiple myeloma randomized clinical trials reported postprotocol therapies, with a low proportion of patients receiving these therapies, often not meeting the standard of care. Reporting guidelines for postprotocol therapies are urgently needed to improve the reporting quality in ongoing and future trials.
Review
Orthopedics
Johan von Heideken, Sana Chowdhry, Joanna Borg, Khara James, Maura D. Iversen
Summary: The study found that in some therapeutic exercise studies, the reasons for dropouts could be considered adverse events, leading to potential underreporting of harm. There was a significant improvement in reporting of harm pre- and post-CONSORT-2010. Greater clarity regarding the definitions of adverse events, dropouts, and therapeutic exercise intensity is needed to determine the safety of therapeutic exercise for knee osteoarthritis.
Review
Dermatology
Michelle J. Chang, Yuqing Qiu, Shari R. Lipner
Summary: Consistent reporting of races and ethnicities of onychomycosis clinical trial participants with subgroup analyses of treatment efficacies is needed, as highlighted by this study.
Review
Medicine, General & Internal
Scott C. Adams, Julia McMillan, Kirsten Salline, Jessica Lavery, Chaya S. Moskowitz, Konstantina Matsoukas, Maggie M. Z. Chen, Daniel Santa Mina, Jessica M. Scott, Lee W. Jones
Summary: This study evaluated the reporting and conduct quality of exercise randomized controlled trials in clinical populations, finding that the overall quality of exercise RCTs was lower compared to matched pharmacological RCTs. Factors associated with higher quality in exercise RCTs included journal impact factor, sample size, and publication year. The study highlights the importance of improving the reporting and conduct quality of exercise trials in clinical populations.
Review
Rehabilitation
Xin Rong Gladys Leow, Si Li Annalyn Ng, Ying Lau
Summary: This review evaluates the effectiveness of overground robotic exoskeleton (RE) training in improving walking ability, speed, and endurance among stroke patients. The results indicate that overground RE training can significantly improve walking ability and speed at postintervention and follow-up. It is recommended to combine overground RE training with conventional rehabilitation and adopt a gait training regime of <4 times per week, >= 6 weeks, and <= 30 minutes per session for chronic stroke patients.
ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION
(2023)
Review
Immunology
Yuhong Wang, Chen Chen, Wei Du, Yixin Zhou, Lina He, Shaodong Hong, Li Zhang
Summary: This study evaluated the reporting quality of adverse events (AE), especially immune-related AE (irAE), in immunotherapy clinical trials. A total of 123 publications were included and assessed using a 16-point harm reporting quality score (HRQS). The findings showed that AE reporting in immunotherapy trials is suboptimal, highlighting the need for improvement and standardization of reporting practices.
FRONTIERS IN IMMUNOLOGY
(2022)
Review
Orthopedics
Khara A. James, Johan von Heideken, Maura D. Iversen
Summary: This study aimed to describe adverse events and dropouts in therapeutic exercise for hip osteoarthritis, and to evaluate whether CONSORT guidelines were followed. The findings showed inconsistent reporting of adverse events, potential misclassification of dropouts, and frequent lack of reporting on key components of exercise interventions. Despite these limitations, the overall low number of nonserious adverse events suggests minimal risk of harm related to exercise for individuals with hip osteoarthritis. Consistent and informative reporting of adverse events, dropouts, and exercise interventions is needed, along with increased used of the CONSORT harms-reporting checklist.
Review
Clinical Neurology
Emily J. Dalton, Natasha A. Lannin, Bruce C. Campbell, Leonid Churilov, Kathryn S. Hayward
Summary: This study examined the generalizability of findings in upper-limb motor trials conducted early post-stroke. The results showed that key information to support the generalizability of trial findings was insufficiently reported, and broadening eligibility criteria alone may not be enough to improve trial inclusivity due to internal validity constraints.
INTERNATIONAL JOURNAL OF STROKE
(2023)
Review
Clinical Neurology
Gengbin Chen, Manfeng Wu, Jialin Chen, Cailing Zhang, Quan Liu, Yinchun Zhao, Guangqing Xu, Yue Lan
Summary: This study identified that stroke rehabilitation therapy can increase the level of serum brain-derived neurotrophic factor (BDNF) and other biomarkers, which are associated with the improvement of stroke patients' function.
FRONTIERS IN NEUROLOGY
(2023)
Review
Oncology
Diego Enrico, Federico Waisberg, Jeannette Burton, Pablo Mando, Matias Chacon
Summary: The study systematically reviewed the quality of adverse events reports in oncology trials and found that the reporting and attribution process were more unreliable than expected. A high proportion of trials did not provide complete adverse event attribution reports, and journals with lower impact factors were associated with deficient reporting of grade 3-4 adverse events.
CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
(2021)
Review
Clinical Neurology
Bridget Burton, Megan Isaacs, Emily Brogan, Kirstine Shrubsole, Monique F. Kilkenny, Emma Power, Erin Godecke, Dominique A. Cadilhac, David Copland, Sarah J. Wallace
Summary: The aim of this study was to identify and evaluate high-quality stroke guidelines that can inform aphasia management. We identified 9 high-quality guidelines and extracted 82 recommendations for aphasia management. Most recommendations were aphasia-related, but there were gaps in aphasia-specific recommendations in the areas of accessing community supports, return to work and leisure, driving, and interprofessional practice.
INTERNATIONAL JOURNAL OF STROKE
(2023)
Review
Medicine, General & Internal
Qing Zhao, Xue Wang, Tao Wang, Adam A. Dmytriw, Xiao Zhang, Kun Yang, Jichang Luo, Xuesong Bai, Nan Jiang, Bin Yang, Yan Ma, Liqun Jiao, Yunyan Xie
Summary: This systematic review aims to compare the efficacy of cognitive rehabilitation interventions for patients with post-stroke cognitive impairment, and the results will help with clinical decision-making and support the development of clinical practice guidelines.
SYSTEMATIC REVIEWS
(2021)