About the Efficacy of a Serious Game in Critical Appraisal
Condition: Healthy Students
Study type: Interventional

Summary: 
      Background: serious games have been reported as valuable method of learning since a decade.
      Even if their evident efficiency hasn't been always reported, their influence on the
      learners' motivation has become consensual. The authors aim to assess the efficacy of using
      serious games to teach critical appraisal practice to medical students in comparison to
      face-to-face learning methods.

      Material and methods: the authors will perform a cluster randomised controlled trial
      including third-year medical students. Both groups will receive the same initial learning
      about elementary principals of evidence-based-medicine. Then, the control group will perform
      a critical appraisal of a case report and a recommendation article guided by a checklist and
      the intervention group performed a critical appraisal of the same manuscripts using a
      home-made serious game. Both groups will be invited to fulfil a multiple-choice-question test
      and a satisfaction likert-scale questionnaire.
    

Detailed description: 
      -  Population: since 2013, 25 students in the third year of medical training are received
           in the Department of Pathology every year. The students were divided into 7 groups of 4
           to 5 students with an interval period of 2 to 3 weeks between the different groups. The
           students were assigned randomly by the faculty of medicine of Tunis. The training period
           lasts three weeks according to the university's recommendations. All the students that
           were assigned by the faculty and who gave their consent to participate to this study
           were included. The students that were performing their training period in other
           Departments were excluded.

        -  Type of study: this is a cluster randomised controlled trial. This kind of randomization
           will be used because of the university board's assignment. It seems more comfortable to
           the tutor to use the same method of learning to every group.

        -  Intervention: this interventional and longitudinal study will be performed during a
           year-period. The students' groups will be randomly assigned to two groups by using
           computerised random number allocation and will be given the same pre and post test to
           answer. The test consists in a 7 general multiple-choice-questions in addition to 5
           multi-choice questions related to a manuscript. Besides, The trainees will fulfil a
           Likert-type-scale satisfaction questionnaire to report their self-assessed competences
           and their motivation. Every suggestion will be coted between 1 to 4.

        -  Learning activities: training objectives are listed in the students' university
           portfolio. These objectives were performed by the faculty staff and validated by the
           pedagogical committee. The objectives were divided into items related to technical
           skills, the resolution of problems, ethical attitude and the critical appraisal of a
           scientific publication.

      A diary about the daily activities of the students is available in the e-portfolio of the
      students. It contains their repartition in the Department and the different learning
      activities. Different methods of learning are displayed in the Department of Pathology
      including traditional methods which consisted in lectures dealing with the pathologies
      mentioned in the training board, integrative and participative methods consisting in
      case-based and problem-based learning.

      The five steps of the evidence-based-practice (EBP) are planned during the third week. During
      the 4 initial days, the tutor will initiate the students to the elementary principles of
      evidence-based-medicine practice. Learning methods are mainly lecture-based. During the fifth
      day, groups that are randomized to the control group will participate to a workshop, which
      consisted in a collective critical appraisal session. The students will perform a critical
      appraisal of a case report and guidelines entitled: "Spontaneous regression of locally
      advanced non small cell lung cancer" and "Early and locally advanced non-small-cell lung
      cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up"
      (7,8). The choice of case report and recommendations was motivated by the fact that the
      students have never been practicing critical appraisal. The students will be given a
      checklist of the Tunisia medical journal (http://www.latunisiemedicale.com/) in order to
      facilitate this practice.

      The intervention group will practice a critical appraisal of the same manuscript using the
      serious game developed by the tutor.

        -  Serious game: the authors developed a simulation-based serious game with design elements
           consisting in avatars, scores and explanations. This game was performed using itystudio
           software. The different scenes took place into a medical consultation. The students
           (players) have to choose the doctor's avatar. A realistic scenario was performed in
           order to include the approach of critical appraisal into a realistic health problem. The
           scenario performed was a 50-year-old-patient visiting his family doctor to explore an
           episode of haemoptysis. This episode was explored and the medical doctor had to announce
           the diagnosis of lung cancer to his patient. In order to explain the disease to the
           patient and to prepare him to the future investigations and to the treatment modalities,
           the doctor had to deal with a case report about a spontaneous regression of a lung
           cancer then recommendations of the ESMO. With every article downloaded by the students,
           a series of questions were asked and scored. When the students gave the good answers,
           the game continued and if they failed the game was over. Every student had the
           opportunity to repeat the game. Three competences were evaluated: announcing bad news,
           the critical appraisal of a case report and the critical appraisal of recommendations.
           Every competency was scored and the player received the final scores represented into 3
           axes in the end of the game. The scenario established to perform the game is represented
           in figure 2. Some illustrations of the game are represented in figure 3. The game was
           also made available through the Department site link:
           https://sites.google.com/a/fmt.utm.tn/externes-services-d-anatomie-pathologique-prof-mez
           ni/. The major characteristics of the game are represented in table 2.

        -  Statistics: statistical tests used to compare the scores between both groups consisted
           in student test with alpha levels set at 0.05. The authors used SPSS software (version
           20.0).
    

Intervention name(s): serious game
Intervention type(s): Other
Intervention description(s): a serious game was performed by the investigators in order to enhance the critical appraisal practice of students
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other