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AN OBSERVATIONAL MULTICENTRE STUDY TO PROMOTE INDEPENDENT CLINICAL RESEARCH AND EDUCATION TO YOUNG HOSPITAL PHARMACISTS: THE QOSMOS PROJECT (submitted in 2019)

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European Statement

Education and Research

Author(s)

Daniele Mengato, Federica Milani, Laura Agnoletto, Nicoletta Freddi, Roberta Rampazzo, Vera Damuzzo, Nicola Realdon

Why was it done?

Recently, the national monitoring of Hospital Pharmacy Students (SHP) highlighted a lack of education in clinical research and in designing of independent studies among students. To fill this gap, we established a collaboration between Scientific Associations and Student Organisations.

What was done?

In 2017 the Italian Society for Clinical Pharmacy and Therapeutics (SIFaCT) and the National Association of Hospital Pharmacy Students (ReNaSFO) established a join action to improve students’ research competencies. To this end, we designed the QOSMOS study: “Quality Of life (QoL) in Multiple Sclerosis (MS): a Multicentre Observational Study”.

How was it done?

The study has both educational and scientific objectives. Scientific objectives were to update data on QoL in MS and to correlate QoL to drug therapy. Regarding the educational challenge, every SHP participant received, by a panel of expert colleagues, the methodologic basis on observational studies and how to arrange teamwork activities. SHP could participate either as co-investigators or as members of teams which managed ethical approval, case report form (CRF), study monitor and data analysis. Investigators enrolled patients, collected clinical data and administrated a CRF, consisting of a questionnaire on QoL (MSQoL54).

What has been achieved?

22 SHP from 16 Italian centres, equally distributed from Southern to Northern Italy, joined the project. 20 SHP participated as co-investigators, one was included in the Scientific Committee of the study and 1 participated in the team dedicated to the Ethical Committee. We enrolled 341 patients with relapsing/remitting MS from May 2018 to June 2019 (median=20 per centre). The study achieved primary and secondary endpoints and pointed out a significant decrease in QoL related to physical health in patients treated with teriflunomide compared to other oral drugs (p=0.002).

What next?

Results will be presented in a scientific paper for submission to a peer-reviewed journal. This final aspect of the project has an educational goal once again, namely to bring young colleagues closer to writing and disseminating science. As QOSMOS gained good results, a new study investigating the role of clinical pharmacist in the Infectious Disease Department is starting with the goal to investigate optimisation strategies for treatment of HIV-positive patients.

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