Orthopaedic Surgery Clinical Trial
Official title:
Improving Medication Safety: Development and Impact of Multivariate Model-based Strategy to Target High-risk Patients of Postoperative Complication
The objective is therefore to create a risk score for ADEs in an orthopedic and
traumatological surgery department.
The study is an prospective, observational, cohort trial. A first step will consist of: (i) a
collection of PIs carried out in an orthopedic and traumatological surgery department for 1
month, (ii) a score of the clinical impact of Pharmacist Interventions using the Clinical,
Econnomic and organisationnal scale by method of consensus and (iii) a statistical analysis.
Statistical analysis consists of (i) logistic regression modeling, (ii) performance
measurement by discrimination and calibration, and internal validation by resampling. In a
second step, external validation using a new sample will be performed.
Pharmaceutical means for clinical pharmacy activities and pharmaceutical analysis are
limited. Several methods can be used to increase the efficiency of resources allocated to
clinical pharmacy activities. We hypothesize that highlighting patients at risk for
iatrogenic drug events (ADEs) by applying a predictive score of ADE could be a way to
increase the efficiency of clinician pharmacist interventions.
b. Assumption (s) and objective (s) The use of a predictive score of ADE in hospitalized
patients in orthopedic surgery would make it possible to prioritize clinical pharmacy actions
according to the resources allocated. The objective is therefore to create a risk score for
ADEs in an orthopedic and traumatological surgery department. The secondary objective is to
evaluate its superiority over other predictive models such as the age or the Physical Status
Score physical status score used by anesthetists.
c. Methodology The study is an prospective, observational, cohort trial. A first step will
consist of: (i) a collection of PIs carried out in an orthopedic and traumatological surgery
department for 1 month, (ii) a score of the clinical impact of Pharmacist Interventions (NPS)
using the Clinical, Econnomic and organisationnal scale by method of consensus and (iii) a
statistical analysis. Statistical analysis consists of (i) logistic regression modeling, (ii)
performance measurement by discrimination and calibration, and internal validation by
resampling. In a second step, external validation using a new sample will be performed.
d. Expected results and prospects The usefulness of clinical pharmacy activities is now
demonstrated, however an improvement in their efficiency is needed. The prospects are the
integration of the risk score in the dispensing assistance software connected to the
computerized patient record as well as extending the score to other types of surgery.
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