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Systematic reviews are routinely used to synthesize current science and evaluate the evidential strength and quality of resulting recommendations. For specific events, such as rare acute poisonings or preliminary reports of new drugs, we posit that case reports/studies and case series (human subjects research with no control group) may provide important evidence for systematic reviews. Our aim, therefore, is to present a protocol that uses rigorous selection criteria, to distinguish high quality case reports/studies and case series for inclusion in systematic reviews. This protocol will adapt the existing Navigation Guide methodology for specific inclusion of case studies. The usual procedure for systematic reviews will be followed. Case reports/studies and case series will be specified in the search strategy and included in separate sections. Data from these sources will be extracted and where possible, quantitatively synthesized. Criteria for integrating cases reports/studies and case series into the overall body of evidence are that these studies will need to be well-documented, scientifically rigorous, and follow ethical practices. The instructions and standards for evaluating risk of bias will be based on the Navigation Guide. The risk of bias, quality of evidence and the strength of recommendations will be assessed by two independent review teams that are blinded to each other. This is a protocol specified for systematic reviews that use case reports/studies and case series to evaluate the quality of evidence and strength of recommendations in disciplines like clinical toxicology, where case reports/studies are the norm.
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http://dx.doi.org/10.3389/fmed.2021.708380 | DOI Listing |
Cutan Ocul Toxicol
September 2025
Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research (NIPER) Guwahati, Kamrup, Assam, India.
Objective: This study aimed to assess the potential risk of Bullous pemphigoid (BP) associated with antidiabetic agents, antimicrobials, diuretics, immune checkpoint inhibitors, and biological agents.
Research Design And Methods: A retrospective pharmacovigilance data analysis was conducted using the FDA Adverse Event Reporting System (FAERS) between Q1/2004 and Q3/2024. Disproportionality analyses, viz.
Background: Acupuncture is a widely recognized complementary therapy with proven therapeutic benefits; however, concerns regarding patient safety persist due to adverse events ranging from minor complications to severe outcomes like pneumothorax and nerve injury.
Objective: This study aims to identify common adverse events in acupuncture, propose innovative risk mitigation strategies, establish standardized best practices, enhance practitioner training, and examine global disparities in safety protocols.
Design: Comprehensive review of existing literature, clinical case studies, and international safety guidelines.
Med Acupunct
August 2025
Kampo Clinical Center, Hiroshima University Hospital, Hiroshima, Japan.
Background: Acupuncture and moxibustion (AM) are effective for pain relief and chronic disease management but carry risks of adverse events (AEs). Japan prioritizes AM safety, and Hiroshima University Hospital Kampo Clinical Center (HUHKCC) follows strict professional standards to ensure both safety and efficacy.
Objectives: The study analyzes AM-related AEs in Japan over the past decade, compares them with HUHKCC practices, and proposes risk mitigation strategies.
Front Immunol
September 2025
Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Introduction: Anti-N-methyl-D-aspartate receptor (NMDA-R) encephalitis is a neuropsychiatric disorder with additional psychiatric features caused by NMDA-R immunoglobulin G (IgG) antibodies in cerebrospinal fluid (CSF). This report presents the follow-up of a patient in whom we assumed mild NMDA-R encephalitis in the first psychotic episode.
Case Study: A patient with a prior episode of an acute polymorphic psychotic syndrome relapsed five and a half years later following a severe COVID-19 infection.
Med Int (Lond)
August 2025
Department of Oncology, Combined Military Hospital/National University of Medical Sciences, Rawalpindi 46000, Pakistan.
Follicular dendritic cell sarcoma (FDCS) is a rare tumour derived from dendritic cells located in B-follicles that play a pivotal role in the adaptive immune response. Surgery is the mainstay of treatment for localized disease; however, the management of unresectable or advanced disease is less well-defined. To date, to the best of our knowledge, there is no established or preferred chemotherapeutic regimen, although a number of regimens (primarily used in lymphomas and sarcomas) have been utilized with suboptimal outcomes.
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