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Background: Underreporting of harms in randomized controlled trials (RCTs) may lead to incomplete or erroneous assessments of the perceived benefit-to-harm profile of an intervention. To compare benefit with harm in clinical practice and future clinical studies, adverse event (AE) profiles including severity need to be understood. Even though patients report harm symptoms earlier and more frequently than clinicians, rheumatology RCTs currently do not provide a reporting framework from the patient's perspective regarding harms. Our objective for this meta-research project was to identify AEs in order to determine harm clusters and whether these could be self-reported by patients. Our other objective was to examine reported severity grading of the reported harms.
Methods: We considered primary publications of RCTs eligible if they were published between 2008 and 2018 evaluating pharmacological interventions in patients with a rheumatic or musculoskeletal condition and if they were included in Cochrane reviews. We extracted data on harms such as reported AE terms together with severity (if described), and categorized AE- and severity-terms into overall groups. We deemed all AEs with felt components appropriate for patient self-reporting.
Results: The literature search identified 187 possible Cochrane reviews, of which 94 were eligible for evaluation, comprising 1,297 articles on individual RCTs. Of these RCTs, 93 pharmacological trials met our inclusion criteria (including 31,023 patients; representing 20,844 accumulated patient years), which reported a total of 21,498 AEs, corresponding to 693 unique reported terms for AEs. We further sub-categorized these terms into 280 harm clusters (i.e., themes). AEs appropriate for patient self-reporting accounted for 58% of the AEs reported. Among the reported AEs, we identified medical terms for all of the 117 harm clusters appropriate for patient reporting and lay language terms for 86%. We intended to include severity grades of the reported AEs, but there was no evidence for systematic reporting of clinician- or patient-reported severity in the primary articles of the 93 trials. However, we identified 33 terms suggesting severity, but severity grading was discernible in only 9%, precluding a breakdown by severity in this systematic review.
Conclusions: Our results support the need for a standardized framework for patients' reporting of harms in rheumatology trials. Reporting of AEs with severity should be included in future reporting of harms, both from the patients' and investigators' perspectives.
Registration: PROSPERO: CRD42018108393.
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http://dx.doi.org/10.1016/j.semarthrit.2020.09.023 | DOI Listing |
Sci Total Environ
December 2024
Department of Science, Roma Tre University, Viale G. Marconi 446, 00146 Rome, Italy; NBFC, National Biodiversity Future Center, Piazza Marina, 61, 90133 Palermo, Italy. Electronic address:
Pink biofilm formation on stone monuments and mural paintings poses serious harm to cultural heritage preservation. Pink biofilms are globally widespread and recalcitrant to eradication, often causing recurrences after restoration. Yet, the ecological drivers of pink biofilm formation and the metabolic functions sustaining the growth of pigment-producing biodeteriogens remain unclear.
View Article and Find Full Text PDFMethods Mol Biol
December 2024
Department of Biotechnology, Raipur Institute of Technology, Raipur, Chhattisgarh, India.
Glaucoma is a group of eye diseases characterized by progressive harm to the optic nerve that often results in loss of vision and blindness. Recent studies suggest that deregulation in the expression of a particular type of RNAs named long noncoding RNAs (lncRNAs) can impact the development of glaucoma and, hence, are promising targets for drug discovery. LncRNAs are transcripts with a length longer than 200 nucleotides that are not translated into proteins.
View Article and Find Full Text PDFBrain Res Bull
December 2024
Department of Radiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, 310009, Hangzhou, China; Joint Laboratory of Clinical Radiology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. Electronic address:
Background: Personality is a unique and relatively stable psychological concept that defines individual human beings. It strongly influences long-term behavioral styles such as emotional expression. This study aims to elucidate the brain functional underpinning behind personality.
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