Characteristics of registered clinical trials assessing strategies of medication errors prevention. An unusual cross sectional analysis

Noemi Giannetta; Sara Dionisi; Giulia Villa; Rosaria Cappadona; Fabio Fabbian; Alfredo  De Giorgi; Duilio Fiorenzo Manara; Marco Di Muzio; Roberto Manfredini; Emanuele Di Simone

doi:10.23750/abm.v92iS2.11507

Characteristics of registered clinical trials assessing strategies of medication errors prevention. An unusual cross sectional analysis

Authors

Noemi Giannetta Department of Biomedicine and Prevention, University of Rome Tor Vergata, Italy; Vita-Salute San Raffaele University, Milan, Italy.
Sara Dionisi a:1:{s:5:"en_US";s:74:"Department of Biomedicine and Prevention, Tor Vergata University of Rome, ";}
Giulia Villa Center for Nursing Research and Innovation; Vita-Salute University of Milan, Italy
Rosaria Cappadona Department of Medical Sciences, University of Ferrara, Ferrara, Italy
Fabio Fabbian Department of Medical Sciences, University of Ferrara Italy.
Alfredo De Giorgi Department of Medical Sciences, University of Ferrara, Ferrara, Italy.
Duilio Fiorenzo Manara Vita-Salute San Raffaele University, Faculty of Medicine and Surgery, Milan, Italy
Marco Di Muzio Department of Clinical and Molecular Medicine, Sapienza University of Rome, Italy
Roberto Manfredini Department of Medical Sciences, University of Ferrara, Ferrara, Italy.
Emanuele Di Simone Nursing, Technical, Rehabilitation, Assistance and Research Department - IRCCS Istituti Fisioterapici Ospitalieri - IFO, Rome, Italy

DOI: https://doi.org/10.23750/abm.v92iS2.11507

Keywords:

Clinical trials; ICMJE policy; Medication errors; nursing; publication rate; Trend analysis.

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.

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