Noemi Giannetta1, Sara Dionisi2, Giulia Villa3, Rosaria Cappadona4, Fabio Fabbian5, Alfredo De Giorgi6, Duilio Fiorenzo Manara7, Marco Di Muzio8, Roberto Manfredini9, Emanuele Di Simone10. 1. Department of Biomedicine and Prevention, University of Rome Tor Vergata, Italy; Vita-Salute San Raffaele University, Milan, Italy.. noemi.giannetta@uniroma1.it. 2. a:1:{s:5:"en_US";s:74:"Department of Biomedicine and Prevention, Tor Vergata University of Rome, ";}. sara.dionisi@uniroma1.it. 3. Center for Nursing Research and Innovation; Vita-Salute University of Milan, Italy. villa.giulia@hsr.it. 4. Department of Medical Sciences, University of Ferrara, Ferrara, Italy. cpprsr@unife.it. 5. Department of Medical Sciences, University of Ferrara Italy.. f.fabbian@ospfe.it. 6. Department of Medical Sciences, University of Ferrara, Ferrara, Italy. . degiorgialfredo@libero.it. 7. Vita-Salute San Raffaele University, Faculty of Medicine and Surgery, Milan, Italy. manara.duilio@hsr.it. 8. Department of Clinical and Molecular Medicine, Sapienza University of Rome, Italy. marco.dimuzio@uniroma1.it. 9. Department of Medical Sciences, University of Ferrara, Ferrara, Italy.. mfr@unife.it. 10. Nursing, Technical, Rehabilitation, Assistance and Research Department - IRCCS Istituti Fisioterapici Ospitalieri - IFO, Rome, Italy. emanuele.disimone@uniroma1.it.
Abstract
BACKGROUND: ClinicalTrials.gov is the oldest and largest of these registries. Through this, the researchers can explore and monitor the clinical research landscape. In the last decades, the number of Medline-indexed publications on adverse events and medication errors have increased exponentially. The aims were to define the prevalence of clinical trials that have as outcome the medication errors and to describe the characteristics of these trials, including their distribution across countries, and publication rate. METHODS: A cross-sectional analysis of all clinical trials reporting as primary outcome medication errors identified through ClincialTrials.gov. RESULTS: Among 5.881 trials, only 1,68% focused on intervention to improve medication safety process and prevent medication errors. 25,3% of clinical trials included had their primary outcome changed (p= ,005). Recording study results in ClinicalTrials.gov was associated with trials that had their primary outcome changed (OR: ,060; 95% C.I.: ,007 - ,541). Only few interventional trials were totally compliant with the ICMJE policy. For all trials completed in our sample, in mean 7,44 months (median: 12 months) elapsed between study completion and the first publication in Medline showing the trial's identification number. CONCLUSIONS: This study demonstrates several strengths of using ClinicalTrials.gov to track intervention to improve medication safety process. It is unknown how many trials are designed to focus on medication errors. However, 1,68% of trials focused on intervention to improve medication safety process.
BACKGROUND: ClinicalTrials.gov is the oldest and largest of these registries. Through this, the researchers can explore and monitor the clinical research landscape. In the last decades, the number of Medline-indexed publications on adverse events and medication errors have increased exponentially. The aims were to define the prevalence of clinical trials that have as outcome the medication errors and to describe the characteristics of these trials, including their distribution across countries, and publication rate. METHODS: A cross-sectional analysis of all clinical trials reporting as primary outcome medication errors identified through ClincialTrials.gov. RESULTS: Among 5.881 trials, only 1,68% focused on intervention to improve medication safety process and prevent medication errors. 25,3% of clinical trials included had their primary outcome changed (p= ,005). Recording study results in ClinicalTrials.gov was associated with trials that had their primary outcome changed (OR: ,060; 95% C.I.: ,007 - ,541). Only few interventional trials were totally compliant with the ICMJE policy. For all trials completed in our sample, in mean 7,44 months (median: 12 months) elapsed between study completion and the first publication in Medline showing the trial's identification number. CONCLUSIONS: This study demonstrates several strengths of using ClinicalTrials.gov to track intervention to improve medication safety process. It is unknown how many trials are designed to focus on medication errors. However, 1,68% of trials focused on intervention to improve medication safety process.
Authors: Gloria Liquori; Aurora De Leo; Emanuele Di Simone; Sara Dionisi; Noemi Giannetta; Elvira Ganci; Sherly Pia Trainito; Giovanni Battista Orsi; Marco Di Muzio; Christian Napoli Journal: Int J Environ Res Public Health Date: 2022-04-25 Impact factor: 4.614
Authors: Sara Dionisi; Noemi Giannetta; Gloria Liquori; Aurora De Leo; Victoria D'Inzeo; Giovanni Battista Orsi; Marco Di Muzio; Christian Napoli; Emanuele Di Simone Journal: Healthcare (Basel) Date: 2022-06-29