FOLLOW-UP OF OFF-LABEL TOCILIZUMAB PRESCRIPTIONS IN COVID-19 IN A FRENCH UNIVERSITY HOSPITAL
European Statement
Education and Research
Author(s)
Caroline TRAN VAN HO, Marie-Anne ESTEVE, Pierre BERTAULT-PERES, Marjorie ROUDOT
Why was it done?
SARS-CoV-2 infection leads to pro-inflammatory molecules production (in particular IL-6). If the immune system is overwhelmed and cytokine production spikes, a hyper-inflammatory phenomenon occurs: the cytokinic storm, which can bring lead to the admission in an intensive care unit. Due to the absence of authorized treatment, several clinical trials (CTs) and off-label use of drugs have been set up.
What was done?
The aim of this study is to analyse the off-label use of tocilizumab in a French university hospital in comparison with different CTs.
How was it done?
A retrospective study of tocilizumab prescriptions in Covid-19 was conducted between 01/03/2020 and 30/04/2021 by extracting data from Computerised Physician Order Entry and Pharmacy Management software (Pharma®). History of patients was recovered by electronic medical records (Axigate®).
Results were compared to (1) RECOVERY Collaborative Group. Lancet. 2021, (2) Hermine O. JAMA. 2021, (3) Rosas IO. N Engl J Med. 2021, (4) Salama C. N Engl J Med. 2021.
What has been achieved?
Between 01/03/2020 and 30/04/2021, 68 patients received tocilizumab.
Seventy-seven percent of patients were in the intensive care unit and 42.6% died, whereas 31.0%, 19.7%, 11.1% and 10.4% died according to (1), (3), (2) and (4), respectively. Mechanical or invasive ventilation at the time of tocilizumab prescription was widely used (84%) compared to CTs (54.0%, 27.9%, 24.0%, 12.2% for (1), (3), (2), (4)). According to (1), there is a synergistic action between tocilizumab and dexamethasone. Eighty-four percent of patients received at least one dose of corticosteroids in agreement with (1) and (4).
What next?
The increase in off-label use of tocilizumab is related to the results of CTs. Because of the low number of patients, the differences in COVID-19 stages at tocilizumab initiation, and the absence of a control group, it is difficult to explain our data. Given the weak iatrogenic effects revealed in CTs and in-label use, the benefit/risk seems in favor of tocilizumab use against COVID-19. Further studies are needed to confirm the first hopes. Since Casirivimab / imdevimab, and amlanivimab / etesevimab have been granted early access in France, the therapeutic strategy will be updated.
Entrustable Professional Activity in Medical Reconciliation as an assessment tool to measure competency of pharmacy pre-registration students
European Statement
Education and Research
Author(s)
Ula Bozic, Matthias Witti , Jan Zottmann , Martin Rudolf Fischer, Yvonne Marina Pudritz
Why was it done?
Among other functions of EPAs (description of activities as a guide for students, function as a curriculum guideline), they can be used as assessment tools – in our case, to identify gaps in students’ knowledge/skills and, depending on the results, to aid guiding curricula development of our educational program to ensure high quality training service.
What was done?
Entrustable professional activities (EPAs) are observable clinical activities consisting of knowledge, skills and attitudes that can be entrusted to learners over time. In German pharmacy education, EPAs have not yet been developed or used. For this project, we developed a Medical Reconciliation EPA for pharmacy pre-registration students taking part in a rotational programme at LMU University Hospital Munich. Four steps were required for the development: (1) Development of content for EPA description and the associated checklist by a working group of clinical pharmacists through literature review and work analysis. (2) Validation of the developed EPA and checklist by an independent expert group of clinical pharmacists from across Germany. (3) Application of the EPA and checklist in an assessment situation to check for inter-rater reliability. (4) Roll-out of EPA and checklist for assessment of pharmacy pre-reg students at LMU.
How was it done?
Since EPAs are a new concept in (German) pharmacy education, their concept as well as their assessment process with entrustment decisions required explanation in detail to facilitators and students alike in several workshops, which we have successfully organised and executed.
What has been achieved?
Through the implementation of this EPA, we can assess students’ competencies in performing medication reconciliation, identify the weaknesses of our training programme and adapt the content to improve students` skills in their performance.
What next?
Further EPAs with a focus on hospital discharge and medication analysis are being developed. With EPAs, it is possible to translate theoretical competencies into observable activities that can be assessed in a clinical setting. As pharmacists in Germany are increasingly involved in clinical practice, there is a need to assess their skills in performing day-to-day clinical tasks. EPAs are an excellent tool for this purpose.
Patient education after Arthroplasty: what about the implants?
European Statement
Education and Research
Author(s)
Lionel Tortolano, Quentin Misandeau, Muriel Paul, Valérie Archer
Why was it done?
The main objective was to make give more information to the patients and draw their attention on the implant and the signs of adverse events.
What was done?
In 2018, in order to respond to both the sanitary traceability regulatory and the iatrogenic prevention, we initiated a new education session for patients after their hip or knew surgery.
How was it done?
First, the educational tools were developed in collaboration with surgeons, nurses and physiotherapist.
Each patient is seen after his surgery for the educational interview. At the beginning, the pharmacist asks him questions grouped in 4 themes: the implant, adverse events, prohibited movements and medicines.
According to patient answers, the pharmacist gives him complementary information and documents: an implant card and a booklet, which summarized all essential keys about adverse events and the return home.
We measured the efficiency of our education sessions on the knowledge of 80 patients. After the education session, before the return home, the patient was asked a second time to respond to all questions previously asked. The difference of good answers was considered as an increase of awareness.
What has been achieved?
The results show significant impact of this education session on all items especially those regarding the implants and medicines.
What next?
Since this feasibility study, we perpetuate those education sessions. We initiate a randomized prospective study to measure the impact 6 month after surgery on patient knowledge and potential impact on adverse event incidence rate. The result of this second study are expected to spring 2022.
SESAME QUIZ: A PLAYFUL ONLINE QUESTIONNAIRE TO ASSESS PATIENTS’ KNOWLEDGE ABOUT SJOGREN’S SYNDROME
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European Statement
Education and Research
Author(s)
Charlotte Ménage-Anjuère, Rakiba Belkir, Elisabeth Bergé, Audrey Decottignies, André Rieutord, Xavier Mariette, Raphaèle Séror
Why was it done?
We needed to assess the impact of our patient education program on Sjogren’s syndrome (SESAME) in order to continuously improve it.
What was done?
A playful online questionnaire was designed and implemented to assess patients’ knowledge about Sjogren’s syndrome.
How was it done?
A interprofessional team (3 rheumatologists, 3 pharmacists) and a 4-patient group who participated in the education program together proceeded to the questionnaire design: 1) definition of a competency framework for patients with Sjogren’s syndrome; 2) from literature review, identification of quality requirements for a questionnaire (scientific quality, opportunity to interact, means of expression, logical chaining of questions, simplicity, utility, shortness, bias prevention, playfulness, variety, online diffusion). To fulfill these criteria, we used a clear vocabulary and concise questions, included open-ended questions on patient experience, focused on the artwork, randomized the order of answer choices, and shared the questionnaire online. Once the SESAME quiz was established, a scoring system was defined by the expert group. Face validity, feasibility and reproducibility were assessed to validate the questionnaire. 25 patients were contacted to complete the questionnaire twice. Patients also evaluated the content, structure and feasibility using 12 items (understandable language, unambiguous sentences, length of the questionnaire, difficulty, web access). Reproducibility was calculated using intraclass correlation coefficient (ICC) on patient answers separated by 48 hours.
What has been achieved?
The questionnaire includes 28 questions divided into 4 parts: Sjogren’s signs, Sjogren’s causes, treatment, daily life with the disease. The 25 patients filled in the questionnaire twice (96% women, 54 years min-max[23;74], 4 years since the diagnosis min-max[1;20]). The questionnaire was filled in from a computer (n=38), a tablet (n=3) or a smartphone (n=9). The average response time was 19 minutes. The median score was 34 points min-max[22;46] out of 50. 18 patients evaluated the questionnaire. 15 patients or more regarded its content, organization and feasibility as “very good”. 5 patients found it difficult. The reproducibility was very high (total ICC = 0.87 IC95% [0.74-0.94], ICC on each part between 0.61 et 0.87).
What next?
The SESAME quiz is now freely available (https://etp-rhumato.typeform.com/to/qsVhR1) and all the Hospital centers caring for Sjogren patients can use it for their follow up.