Development of a ‘ready-to-use’ tool that includes preventability, for the assessment of adverse drug events in oncology

  • Guillaume Hébert
  • Florence Netzer
  • Sylvain Landry Kouakou
  • François Lemare
  • Etienne Minvielle
  • the IATRIGGER Working Group
Research Article

Abstract

Background Adverse drug events (ADEs) occur frequently in oncology and justify continuous assessment and monitoring. There are several methods for detecting them, but the trigger tool method seems the most appropriate. Although a generic tool exists, its use for ADEs in oncology has not been convincing. The development of a focused version is therefore necessary. Objective To provide an oncology-focused trigger tool that evaluates the prevalence, harm, and preventability in a standardised method for pragmatic use in ADE surveillance. Setting Hospitals with cancer care in France. Method The tool has been constructed in two steps: (1) constitution of an oncology-centred list of ADEs; 30 pharmacists/practitioners in cancer care from nine hospitals selected a list of ADEs using a method of agreement adapted from the RAND/UCLA Appropriateness Method; and (2) construction of three standardised dimensions for the characterisation of each ADE (including causality, severity, and preventability). Main outcome measure The main outcome measure was validation of the tool, including preventability criteria. Results The tool is composed of a final list of 15 ADEs. For each ADE, a ‘reviewer form’ has been designed and validated by the panel. It comprises (1) the trigger(s), (2) flowcharts to guide the reviewer, (3) criteria for grading harm, and (4) a standardised assessment of preventability with 6–14 closed sentences for each ADE in terms of therapeutic management and/or prevention of side-effects. Conclusion A complete ‘ready-to-use’ tool for ADE monitoring in oncology has been developed that allows the assessment of three standardised dimensions.

Keywords

Adverse drug event France Healthcare quality Oncology Patient cancer care Preventability Trigger tool 

Notes

Funding

The study was funded by the Directorate of Health Care Supply of the French Ministry of Health.

Conflicts of interest

The authors declare no conflicts of interest with the content of the article.

IATRIGGER Working Group

Dr Elias Assaf, Dr Christophe Bardin, Dr Florence Basuyau, Prof. Pierrick Bedouch, Dr Dominique Charlety, Dr Nathalie Contentin, Dr Mikael Daouphars, Prof. Frédéric Di Fiore, Dr Ludovic Doucet, Dr Cécile Guillemet, Dr Anne-Chrisitine Joly, Dr Charlotte Joly, Dr Fabien Le Bras, Dr Marianne Leheurteur, Dr Marion Lottin, Dr Mélodie Lucas, Dr Isabelle Madelaine, Prof. Véronique Merle, Dr Nathalie Pons-Kerjean, Dr Jordi Remon-Masip, Dr Benoit Rousseau, Dr Jean Rouvet, Dr Caroline Saldana, Dr Florian Slimano, Dr Anne-Claire Toffart, Prof. Christophe Tournigand, Prof. Remi Varin, Dr Anne Vekhoff and Dr Muriel Verlinde-Carvalho.

Supplementary material

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Supplementary material 1 (DOCX 25 kb)
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Supplementary material 2 (DOCX 54 kb)
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Supplementary material 3 (PPTX 1264 kb)
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Supplementary material 4 (DOCX 21 kb)

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Copyright information

© Springer International Publishing AG 2018

Authors and Affiliations

  1. 1.Département de Pharmacie CliniqueGustave RoussyVillejuifFrance
  2. 2.Mission ‘Innovative Pathways’Gustave RoussyVillejuifFrance
  3. 3.Research Team ‘Management des Organisations de Santé’ (EA 7348) École de Hautes Études en Santé PubliqueRennes CedexFrance
  4. 4.Pharmacie Clinique, PRES Sorbonne Paris-Cité, Faculté de PharmacieParisFrance

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