SHORT COURSE IN

CLINICAL RESEARCH AND EVIDENCE-BASED MEDICINE (SCREM)

1. GENERAL INFORMATION

Clinical research in low to middle income countries is at the moment often conceived and implemented by specialized (foreign funded) institutions involving local and expatriate staff who pursue an academic career. Local clinicians in regional and national hospitals (even district hospitals) are often operationally involved in the data collection. This leads to frustration as it becomes a mechanic business. These same clinicians, however, are aware that there is much information they could use themselves to do ‘low scale' research to enhance their own decision making. While the former academically oriented clinicians develop their research skills through doctoral study programs the latter miss training opportunities covering their needs. The SCREM aims at filling this gap.

The SCREM targets professionals who are responsible for clinical quality assurance, for local guideline and/or algorithm development and for coaching junior staff in clinical research. More specifically: medical superintendents, heads of clinical or nursing departments, heads of labs pharmacists, all in referral and/or reference hospitals, thesis supervisors in medical schools/faculties/ nursing and laboratory schools, public health staff in charge of development of national or regional clinical guideline.

1. PROGRAM

Content

Starting from a practical question participants encountered in their clinical work, a critical analysis of literature is done and an applied research protocol is identified at the start of the course.

The following contents will be contextualized individually and/or in small groups:

• Protocol development: from observation to hypothesis, from hypothesis to study methodology and sampling populations;
• Statistics: basic statistical software use, interpretation and mastering the dialogue with the statistician, how to present statistical information for a proposal, a paper or a report;
• Presentation of results in a written (abstract) and oral (power point presentation) way;
• Critical reading: pitfalls in research (bias in hypothesis, in inclusion, in analysis, in interpretation, in applicability);
• Literature search: how to run a literature search, levels and types of evidence of published research;
• Principles of EBM & Introduction into constructing and evaluating guidelines and algorithms;
• IT skills: Excel, Reference Manager, Statistical program (Stata, Epi Info or SPSS)

Seminars:

• Standard Operating Procedures (SOP);
• Ethical aspects of research;
• Research funding;
• Introduction to principles of GCP.

Learning objectives:

At the end of this course the participant should be able to:

• Retrieve relevant published articles relative to the research question and evaluate relevance of clinical research results in relation to a concrete low resource setting;
• Design a research project in the filed of aetiology of health problems, effectiveness and efficiency of diagnostics, clinical management and disease prevention in low resource settings;
• Apply principles of EBM. This includes the ability to use gathered evidence in guideline and algorithm development and the ability to evaluate guidelines;
• Communicate research results to both professional and scientific communities in written and oral way.

In addition, the participant will gain basic comprehension of:

• Pitfalls of implementation of research projects;
• Writing standard operation procedures;
• Good Clinical Practice (GCP) and ethics in clinical research;
• Writing a research grant application including budget and identifying sources of funding for small-scale research projects.

2. TEACHING METHODS

Training in research skills and EBM is a question of "learning by doing" so the course will not be a "rushing through a lot of information" but a hands-on introduction to research and EBM based on a personal project. This method will allow participants to learn while practicing. The course will mainly use adult learning methods. This means a problem oriented training in small groups with regular plenary sessions, coached by a tutor. Throughout the course participants will work on a personal project. Consultants will be invited to discuss specific problems: ethics, statistics, funding etc. based on the different protocols developed by participants, taking them as field examples.

3. EVALUATION AND CERTIFICATE

Evaluation consists of an individual portfolio assessment (5 personal pieces of work required: a description of personal learning interests for the course and 4 pieces chosen by the participant from the different assignments in the course) (70% of final mark) and an individual oral presentation of final research protocol, marked by an expert panel (30% of final mark).

Upon successful completion of this course, students are awarded an ITM credit Certificate in Clinical Research and Evidence-Based Medicine.

4. DURATION OF THE COURSE

The program lasts 6 weeks starting from the second Monday of November.

For a work load of maximum 45 hours, some 26 hours will be contact hours: the major part will be group work alternated with plenary sessions, commented by consultants. One morning a week will be systematically free for personal work.

5. LANGUAGE

The course is organized in English. Students should be able to read and interpret perfectly English texts. Non-native English speakers or participants who did not use English as course language during previous academic studies should reach a TOEFL score 580 (paper based), 230 (computer based), or an IELTS of 6.5.

6. ADMISSION REQUIREMENTS AND APPLICATION PROCEDURE

The course is intended for the following persons:

• holders of a medical degree or paramedical university degree of min 240 ECTS credits;
• with a minimum of two years relevant professional experience in the clinical field;
• with past or current involvement in one of these fields:

- research and/or application of EBM,

- development of clinical guidelines and/or algorithms,

- coaching of medical or paramedical theses in health sciences,

- teaching clinical epidemiology / EBM;

• with basic knowledge of statistics and epidemiology (equivalent to the level of a core course in international health);
• with basic computer skills: Word, PowerPoint, Excel;
• with good understanding and expressing abilities in English (proof to be provided if university education has not be done in English: TOEFL 580 (paper based) or 230 (computer based) or IELTS 6.5).

No more than 20 participants will be admitted. A selection will be made through the following criteria:

• motivation mainly based on the description of a personal project (please describe shortly in the application form on page 6, point 6- ‘motivation' a research or EBM project you'd like to work on during the training);
• involvement in actual or past research / EBM application;
• scope of professional experience;
• enrolment in the MIH/tropEd curriculum;
• future career perspectives.

Incomplete applications will not be considered (e.g. missing signature). The application form can be downloaded from www.itg.be > teaching & training. Applications should reach us no later than 30^th April. This course is tropEd accredited.

7. TUITION FEE AND SCHOLARSHIP

You will find information on the exact fee in the general ITM course overview table of our brochure or on our website www.itg.be (teaching & training > course overview). The fee covers tuition and all course materials. This does not include accommodation and living expenses. The student service can assist you in finding accommodation.

A limited number of scholarships from the Belgian Directory General for Development Cooperation are available. Only participants from certain developing countries are eligible (countries are listed in the application form). The scholarships are awarded on a competitive basis. Participant scholarships are available for EU/EFTA candidates covering 80% of registration fee.

After approval of your application, the registration fee should be paid into the ITM's account nr. 220-05311111-72 (Fortis, Warandeberg 3, 1000 Brussel), BIC/SWIFT: GEBABEBB, IBAN BE 38 2200 5311 1172. Bank charges are at the expense of the applicant.