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

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

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.

References

1. World Health Organization. Summary of the evidence on patient safety: implications for research. World Health Organization. Available from: https://apps.who.int/iris/handle/10665/43874, accessed on May 22, 2020.
2. Nebeker JR, Barach P, Samore MH. Clarifying adverse drug events: a clinician's guide to terminology, documentation, and reporting. Ann Intern Med 2004; 140: 795-801.
3. Dequito AB, Mol PG, van Doormaal JE, Zaal RJ, van den Bemt PM, Haaijer-Ruskamp FM, Kosterink JG. Preventable and non-preventable adverse drug events in hospitalized patients: a prospective chart review in the Netherlands. Drug Saf 2011; 34: 1089-100.
4. Council of Europe. Committee of Experts on Management of Safety and Quality in Health Care (SP‐SQS) ‐ Expert Group on Safe Medication Practices: Glossary of terms related to patient and medication safety. 2005. Available from: https://www.who.int/patientsafety/highlights/COE_patient_and_medication_safety_gl.pdf, accessed May 22, 2020.
5. Giannetta N, Dionisi S, Cassar M, Trapani J, Renzi E, Di Simone E, Di Muzio M. Measuring knowledge, attitudes and behavior of nurses in medication management: cross-cultural comparisons in Italy and Malta. Eur Rev Med Pharmacol Sci 2020; 24: 5167-75.
6. Di Simone E, Fabbian F, Giannetta N, Dionisi S, Renzi E, Cappadona R, Di Muzio M, Manfredini R. Risk of medication errors and nurses’ quality of sleep:a national cross-sectional web survey study. Eur Rev Med Pharmacol Sci 2020;24(12):7058-7062.
7. Giannetta N, Cianciulli A, Dionisi S, Figura M, Di Simone E, Di Muzio M. Farmaci orfani: uno sguardo sulle politiche di produzione e ricerca in ambito europeo. GIFAC 2019, 33, 29-34.
8. Giannetta N, Dionisi S, Ricciardi F, Di Muzio F, Penna G, Diella G, Di Simone E, Di Muzio M. Farmaci LASA: strategie per la prevenzione dell’errore da terapia. GIFAC 2019, 33, 119-128.
9. ClinicalTrials.gov. Glossary of common site terms. https://clinicaltrials.gov/ct2/about-studies/glossary (accessed July 25, 2020).
10. US Food & Drug Administration. Food and Drug Administration Modernization Act (FDAMA) of 1997. https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDAMA/default.htm. (accessed July 25, 2020).
11. US Food & Drug Administration. Food and Drug Administration Amendments Act (FDAAA). 2007. Available from: https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm064998.htm, accessed May 22, 2020.
12. Zarin DA, Tse T. Medicine. Moving toward transparency of clinical trials. Science 2008; 319: 1340-2.
13. Zarin DA, Tse T, Williams RJ, Carr S. Trial Reporting in ClinicalTrials.gov - The Final Rule. N Engl J Med 2016; 375:1998-2004.
14. Who.int [homepage on the Internet]. World Health Organization. International Clinical Trials Registry Platform (ICTRP): primary registries. Available from: http://www.who.int/ictrp/network/primary/en/, accessed on May 22, 2020.
15. International Committee of Medical Journal Editors. Clinical trials: registration. [database on the Internet]. Available from: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html, accessed on May 22, 2020.
16. Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. JAMA 2007; 297: 2112-20.
17. Bourgeois FT, Olson KL, Tse T, Ioannidis JP, Mandl KD. Prevalence and Characteristics of Interventional Trials Conducted Exclusively in Elderly Persons: A Cross-Sectional Analysis of Registered Clinical Trials. PLoS One 2016; 11: e0155948.
18. Bourgeois FT, Murthy S, Mandl KD. Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 2010; 153: 158-66.
19. Guo SW. An overview of the current status of clinical trials on endometriosis: issues and concerns. Fertil Steril 2014; 101: 183-190.
20. Hirsch BR, Califf RM, Cheng SK, Tasneem A, Horton J, Chiswell K, Schulman KA, Dilts DM, Abernethy AP. Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Intern Med 2013; 173: 972-9.
21. Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA 2012; 307: 1838-47.
22. Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, Murugiah K, Lu DY, Mittal A, Krumholz HM. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ 2016; 352: i637.
23. Hakala A, Kimmelman J, Carlisle B, Freeman G, Fergusson D. Accessibility of trial reports for drugs stalling in development: a systematic assessment of registered trials. BMJ 2015; 350: 1116.
24. Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009; 302: 977-84.
25. Powell-Smith A, Goldacre B. The TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions. F1000Res 2016; 5: 2629.
26. Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 2009; 6: e1000144.
27. Glanville JM, Duffy S, McCool R, Varley D. Searching ClinicalTrials.gov and the International Clinical Trials Registry Platform to inform systematic reviews: what are the optimal search approaches? J Med Libr Assoc 2014; 102: 177-83.
28. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, Clarke M, Devereaux PJ, Kleijnen J, Moher D. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med 2009; 6: e1000100.
29. Effective Practice and Organization of Care (EPOC). EPOC Taxonomy; 2015. Available from: epoc.cochrane.org/epoc-taxonomy, accessed May 22, 2020.
30. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB; International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International
31. World Health Organization (WHO) / International Committee of Medical Journal Editors (ICMJE). ClinicalTrials.gov Cross Reference. 2019. Available from: https://prsinfo.clinicaltrials.gov/trainTrainer/WHO-ICMJE-ClinTrialsgov-Cross-Ref.pdf, accessed May 22, 2020.
32. Soerensen AL, Lisby M, Nielsen LP, Poulsen BK, Mainz J. Improving Medication Safety in Psychiatry - A Controlled Intervention Study of Nurse Involvement in Avoidance of Potentially Inappropriate Prescriptions. Basic Clin Pharmacol Toxicol 2018; 123: 174-81.
33. Sørensen CA, Lisby M, Olesen C, Enemark U, Sørensen SB, de Thurah A. Self-administration of medication: a pragmatic randomized controlled trial of the impact on dispensing errors, perceptions, and satisfaction. Ther Adv Drug Saf 2020; 11: 2042098620904616.
34. Ramagopalan S, Skingsley AP, Handunnetthi L, Klingel M, Magnus D, Pakpoor J, Goldacre B. Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study. F1000Res 2014; 3: 77.
35. Huser V, Cimino JJ. Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials. PLoS One 2013; 8: e68409.

Downloads

Published

22-12-2021

Issue

Section

Original articles: Health Professions 3/2021

How to Cite

1.
Giannetta N, Dionisi S, Villa G, Cappadona R, Fabbian F, De Giorgi A, et al. Characteristics of registered clinical trials assessing strategies of medication errors prevention. An unusual cross sectional analysis. Acta Biomed [Internet]. 2021 Dec. 22 [cited 2024 Jul. 21];92(S2):e2021503. Available from: https://mattioli1885journals.com/index.php/actabiomedica/article/view/11507