مقاله انگلیسی واحد آزمایشات بالینی تصویربرداری پزشکی: یک نیاز حرفه ای
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Abstract
Purpose
To design and describe a management and control tool and the human resources needed to efficiently manage the imaging process within clinical trials for a better quality of care for the patient.
Methods
A unit was created to efficiently organise the participation of our Medical Imaging Department in clinical trials. This entity was defined and monitored using a customized, flexible and modular software package that provides the necessary information to execute and monitor requests (appointments, protocols, reports, complaints, billing). Various indicators of activity and professional satisfaction were parameterised.
Results
From 2016 to 2020, 367 trials were participated and monitored, 50% of all the hospital clinical trials. The budget of the Medical Imaging Department grew by 47% in this period. The coordination with other departments and principal investigators improved, as shown by surveys (62% fluid and 38% very fluid), with a high perception of collaboration (86%).
Conclusions
The implementation of a Medical Imaging Clinical Trials Unit involve identifying the tasks, personnel, organisational needs, workflow, monitoring and invoicing. The creation of this Unit has improved the control and traceability of clinical trials within the Department.
1. Introduction
Most clinical trials are randomised experimental studies aiming to evaluate the efficacy and safety of a treatment in a select group of patients [1]. Clinical imaging plays a fundamental role in many clinical trials. Different imaging modalities are often used for the initial detection and staging of lesions, to assess response to treatment, and to define adverse effects. In addition, imaging biomarkers are becoming useful to evaluate the biological effects of treatments [2].
Both Radiology and Nuclear Medicine departments are actively involved to carry out the scheduled imaging studies, although the addition of these exams increases the burden of daily workflow [3]. Different organisational strategies have been adopted to establish clinical trials units that act independently on an operational and financial level. In our university hospital, we created a Medical Imaging Clinical Trials Unit (MICTU) in 2016 (Fig. 1) to adequate the participation of the department in trials and to generate resources to foster internal continuous education and research. The unit hired a multidisciplinary team of 8 people with different profiles (1 Nurse, 1 Nursing Assistant, 4 Technicians, 1 Biomedical Engineer, and 1 Business Administration with total costs of 259 K €).