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EXPERIMENTAL DESIGN OF A RANDOMIZED CLINICAL TRIAL: A PILOT PROJECT FOR THE PRACTICAL INTRODUCTION OF THE SCIENTIFIC METHOD IN THE MEDICINE DEGREE
1 Universitat Jaume I (SPAIN)
2 Universitat Jaume I - Hospital General de Castellon (SPAIN)
3 Universitat Jaume I - Servei Valencia de Salut (SPAIN)
About this paper:
Appears in: INTED2014 Proceedings
Publication year: 2014
Pages: 2969-2977
ISBN: 978-84-616-8412-0
ISSN: 2340-1079
Conference name: 8th International Technology, Education and Development Conference
Dates: 10-12 March, 2014
Location: Valencia, Spain
Abstract:
The medicine degree of the Universitat Jaume I is running the third academic year with quite success. In the last INTED 2013, we presented a work about our experience in introducing the scientific method in the curse we are teaching from 2012-2013, named 'Computer resources and information research' (O. Coltell et al., INTED 2013, ID880). That initiative was created in the frame of one of the strategics objectives in the medicine degree: introducing the scientific method in the degree and guiding the students to a basic skills in biomedicine research. As we said in our published work, that objective was partially covered by means of distributing the scientific method teaching in complementary subjects of the first six semesters: Biostatistics (1st y); Informatics (2nd y); Epidemiology and Clinical Management (3rd y). Currently, the situation is the same because every structural change in the degree curriculum must comply with a large and hard revision process in the ANECA (Spanish University Studies Control and Regulatory Agency). Recently, a working committee for redesign the medicine curriculum in order to organize and homogenize the scientific method approach was created. Three of this work authors are members of the committee.

Our past experience in introducing the scientific method in our course 'Computer resources and information research' (code MD1112, 2nd y., 1st s.) brought us to rethink the original teaching approach. The 53% of students were unsatisfied with the methodology applied, even though the 91% agreed with the usefulness of introducing the scientific method in the medicine degree, and the 65% agreed too with doing that in the 3rd semester instead the 1st semester. Considering all this, we have developed another idea to improve the outcome in our subject in the current academic year 2013.2014.

The aim of this work is to describe a new innovative approach based on the Problem-Solving learning methodology: a reduced project team, composed only by students of our subject, assumes the responsibility for proposing a clinical problem, designing a methodologically consistent clinical study, and executing the study inside a simulated environment as a pilot project. The main learning objective is developing the general framework of competencies and learning outcomes of MD1112. This involves the practical application of scientific method in the field of biomedical research, which can also serve as a methodological basis of their clinical practice training cycle that begins in the third academic year. On the other hand, the teacher's team have to provide resources for warrant the start and operation of the pilot project, and scientific and technical support. The teacher's team must also act as external scientific committee supervising study results and following of scientific and ethical regulations.

The pilot project is forested to start on January 7, 2014, and end on July 31, 2014. The success of the project in terms of an educational innovation will be evaluated taking into account the following aspects: Completion of pilot research project, ie, to what extent have applied methods, techniques and technologies for the results associated with the goals of improving teaching; Satisfaction of participating students; Project impact on the results of the course; and Profile of skills and learning outcomes related to research in Health Sciences. Some mechanisms to develop the evaluation aspects will be described and provided.
Keywords:
Scientific method, simulating a clinical study, medicine studies, skills and learning outcomes, problem-based learning, project-based learning, teamwork.