Study Guide. Research Master Programmes in Health Sciences and Clinical Research for medical students

Transcription

1 NIHES RESEARCH TRAINING IN MEDICINE AND THE HEALTH SCIENCES Study Guide Research Master Programmes in Health Sciences and Clinical Research for medical students

2 Adjustments Page 14: correction amount of ECTS of EP03/electives and correction total amount of courses and research Page 15: correction amount of ECTS of EP03/electives and correction total amount of courses and research Page 17: 1 st EWP is in first year Research Master Health Sciences and Clinical Research (instead of the continued year 1 of Research Master), orientation research area is in January of year 2 instead of February year 1, second EWP is in the continued year 1 of Research Master (instead of year 2), correction amount of ECTS of EP03/electives and correction total amount of courses and research. Page 20: adjustment, because schedule is also for option 2 students who started in 2012 (until EWP), correction exam date of EWP04 and EWP16. Page 22: correction exam date of EWP03 and EWP13, correction of the number of ECTS and amount of days for the advanced electives. Page 26: correction exam date of EWP04 and EWP16. Page 28: correction exam date of EWP03 and EWP13, correction of the number of ECTS and amount of days for the advanced electives.

3 Erasmus MC and Netherlands Institute for Health Sciences Study Guide Research Master programmes Health Sciences and Clinical Research for Medical Students

4 2012 Erasmus MC and the Netherlands Institute for Health Sciences, Rotterdam All rights reserved. No part of this study guide may be reproduced, stored in a database or retrieval system, or published, in any form or in any way, electronically, mechanically, by print, photo print, microfilm or any other means without prior written permission from the publisher. Every effort has been made to ensure that the information contained in this study guide is accurate at the time of publication. However, the staff of the master programmes Health Sciences and Clinical Research reserve the right to make changes without prior notice. Erasmus MC and Netherlands Institute for Health Sciences 2

5 Health Sciences & Clinical Research for Medical Students Word of welcome Dear student, In the medical sciences, new knowledge and skills are needed at an ever-increasing level of speed in the medical sciences. Many researchers all over the world contribute to this process. In the center of these new developments stands the doctor, who is able to ask the right questions about patient-related problems and translate them into a research protocol. Such protocols may concern laboratory research and/or applied clinical research. Medical sciences need doctors, with the ability and ambition to combine patient care and research in an academic framework. Erasmus MC is the only university medical center in the Netherlands offering five officially accredited Research Master programmes. These programmes provide the students with the challenge and opportunity to become medical researchers, contributing to the advancement of medical science. Qualified students, who seek the challenge of scientific research, may choose from the five Research Master programmes: Health Sciences, Clinical Research, Infection & Immunity, Molecular Medicine or Neuroscience. This study guide contains all necessary information for students with the ambition to be trained in the field of medical and health sciences and become a Master of Science in Clinical Research or Health Sciences. The programmes include an educational part and a research part. Outstanding researchers with an international reputation will conduct both parts. Take the challenge and provide yourself with the opportunity of a varied and exciting professional career. Good luck! Professor Albert Hofman, MD PhD Programme Director Health Sciences Professor Aart Jan van der Lely, MD PhD Programme Director Clinical Research 3 Study Guide

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7 Health Sciences & Clinical Research for Medical Students Table of Content Word of welcome... 3 Table of Content Aim of the programme Preliminary programme and general information Introduction Schedule & combination of the programme in the medical curriculum at Erasmus MC Recommended books Availability of standard computer software... 8 Time table Preliminary Programme Research Masters Health Sciences and Clinical Research Research Master Programmes option 1 and Schedule & combination of the programme with the regular medical curriculum Programme information Course exemptions from courses of your Research Master programme Course exemptions from courses of your Master of Science in Medicine Course evaluations Cancelling your participation in a course Confidential counsellor...12 Table 1 - start 2012 option Table 2 - start 2011 option Table 3 option Research project & time table Research Master Health Sciences Research project...18 Practical research Your research proposal Presenting your research Your thesis Time table Research Master Health Sciences for Master students in Medicine, option Start 2012 First year Start 2011 Second year Research project & time table Research Master Clinical Research Research project...23 Practical research Your research proposal Presenting your research Your thesis Time table Research Master in Clinical Research Time table Research Master Clinical Research for Master students in Medicine option Start 2012 First year Time table Research Master Clinical Researhc for Master students in Medicine option Start 2011 Second year Examination Procedure and Rules TER and Examination Board Attainment targets Students overall rights and duties Graduation Graduation ceremony NIHES Award and Erasmus MC MSc CR Award After graduation Stay in touch!...33 Annex I NIHES Administration NIHES office hours NIHES intranet Staff Health Sciences & Clinical Research...34 Annex II: Course descriptions NIHES courses... Error! Bookmark not defined. 5 Study Guide

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9 Health Sciences & Clinical Research for Medical Students 1. Aim of the programme The Research Master programmes in Health Sciences and in Clinical Research aim to provide students with a thorough understanding of methods in clinical research and sufficient knowledge of clinical specialist areas, for example medical technology, immunology or molecular biology. On the basis of this knowledge, the student will be prepared to write a research protocol and to perform research. Students should acquire the following competencies: Ability to formulate a clinical problem and translate it into a scientific question. Ability to perform an extensive study of the literature concerning a clinical problem. Ability to translate a scientific question into a research protocol. Acquisition of sufficient knowledge of existing methods of clinical scientific research, biostatistical analytical methods, laws, regulations and ethics and the abilities to use such knowledge in a research protocol. Ability to conduct the research, collect and analyse data, and draw conclusions. Ability to write a Master s thesis, including the objective(s) of the investigation, a summary of the literature, materials, methods, results, discussion and conclusions of the research project and to present these findings at scientific meetings. Publication of the research findings in an international peer-reviewed journal is encouraged. This skills set will enable students to become researchers with the ability to complete a PhD programme, preferably as part of their specialist-education (so-called AGIKO-construction). The ultimate goal of the Research Master in Health Sciences or Clinical Research is to scout excellent students at an early age, challenge them to become clinical investigators, foster them during their research- and clinical career and motivate them to become academic specialists and possibly future professors of medicine. 7 Study Guide

10 2. Preliminary programme and general information 2.1 Introduction In this chapter the general outline of the Preliminary programme will be described. The Preliminary programme is an introduction to the Research Masters Health Sciences and Clinical Research for medical students who attend the Bachelor and Master programmes in Medicine. In chapter 3, the general outline of the Research Master programmes for the BaMa curriculum is described. For more details on the schedules of the BaMa curricula see chapter 4 (Health Sciences) and 5 (Clinical Research). The doctoraal students in Medicine who attend Research Masters Health Sciences or Clinical Research and started in August 2009 the latest, follow the doctoraal curriculum. The general outline of these doctoraal curricula, the Research Master in Health Sciences and the Research Master in Clinical Research is available in the Study Guide or earlier. 2.2 Schedule & combination of the programme in the medical curriculum at Erasmus MC Second year bachelor students in medicine, who are interested in doing research, can attend the keuzeonderwijs Ever thought of doing research? (KOW2), an elective programme in the second year of the Bachelor s programme in Medicine. You can apply for the Preliminary programme of the Research Masters Health Sciences and Clinical Research when you want to attend the Research Master Health Sciences or Clinical Research. When you are admitted to this Preliminary programme, you will start the programme in the third year of your medical bachelor (see the schedule on page 10) You participate in the Erasmus Summer Programme (three weeks), which is held in August. After the Erasmus Summer Programme, you continue with the minor Ever thought of doing research?. This 10 weeks programme is organized by several Erasmus MC Research Master programmes. From November to the following August you get acquainted with your research area and attend research seminars. Research Seminars run parallel to the medical curriculum. Preliminary students Health Sciences receive a seminar booklet in which they can register their seminars with the original signature of the lecturer. Preliminary students Clinical Research can register their seminars in their Personal Education Programme (PEP) (see chapter 5 for details). At the end of your third year Bachelor in Medicine the selection committee will decide whether you can start with the research master. 2.3 Recommended books With a few exceptions, all course materials are included in the NIHES tuition fee. Below are the exceptions, which are valuable assets for the courses. The following textbooks are strongly recommended: For Study Design (CC01): Epidemiology an Introduction, Kenneth Rothman. (ISBN 13: ) For Biostatistical Methods I: Basic Principles, previously known as Classical Methods for Data-Analysis (CC02): Statistical Methods in Medical Research, P. Armitage, 4 th edition (ISBN 10: / ISBN 13: ) or An Introduction to Medical Statistics, Martin Bland, 3 rd edition (ISBN 10: / ISBN 13: ). You can buy each of these books at Selexyz Donner, the bookstore at Lijnbaan 150 (in the center of Rotterdam). 2.4 Availability of standard computer software At Erasmus MC: SAS for Windows SPSS for Windows Various standard applications such as Microsoft Office and internet and programs All other applications available through the network Helpdesk Computer Support: [email protected] / Phone: Erasmus MC and Netherlands Institute for Health Sciences 8

11 Health Sciences & Clinical Research for Medical Students Time table Preliminary Programme Research Masters Health Sciences and Clinical Research Summer 2012 Introductory courses Erasmus Summer Programme ECTS Dates Time Location Principles in Research in Medicine and Epidemiology (ESP01) Aug Daily from to hours Woudestein, Rotterdam Clinical Decision Analysis (ESP04) Aug Daily from to hours Woudestein, Rotterdam Methods of Clinical Research (ESP10), or if you have attended KOW2, theme 16 Methods of Public Health Research (ESP11) Aug Daily from to hours Woudestein, Rotterdam Markers and Prognostic Research (ESP62) Aug Daily from to hours Woudestein, Rotterdam The Practice of Epidemiologic Analysis (ESP65) Aug Daily from to hours Woudestein, Rotterdam Social Epidemiology (ESP61) Aug Daily from to hours Woudestein, Rotterdam Fall 2012 Minor Ever thought of doing research? ECTS Dates Examination/Re-exam Location Study Design (CC01) 3 21 Sep 21 Sep Re-exam: 9 Jan 2013 Erasmus MC, Rotterdam Biostatistical Methods I: Basic Principles (CC02) 24 Sep 19 Oct 19 Oct Re-exam: 11 Jan 2013 Erasmus MC, Rotterdam Further specific Minor programme Oct - Nov Attendance and assignments. Erasmus MC, Rotterdam Research Orientation rsearch area Nov 2012 Aug 2013 Advanced courses - Seminars Seminars Nov 2012 Aug When you have attended this programme you receive an exemption of 10 ECTS (for CC01 and CC02) in your Research Master programme (Please note that this is NOT the number of ECTS for the minor in your Bachelor in Medicine.). 9 Study Guide

12 3. Research Master Programmes option 1 and 2 In this chapter general information will be given about the courses and research training of the Research Master programmes Health Sciences and Clinical Research (BaMa curricula). The programmes can be combined with the regular medical curriculum at Erasmus MC. You can choose between two options: attend the main part of the research master before your internships or co-schappen (option 1) or after your internships (option 2). If you start the Research Master programme in August 2012 (and the preliminary programme in 2011), you have to choose between the two options before 1 October Please also inform NIHES of your choice, by ing the NIHES Administrative office, so we can enrol you in your programme. Information on these programmes you can find in chapter 4 (Health Sciences) and 5 (Clinical Research). 3.1 Schedule & combination of the programme with the regular medical curriculum The Research master programme Clinical Research or Health Sciences can be combined with the medical curriculum at Erasmus MC. This is shown in the figures on pages 13 to 17. The programme for option 1 is described in table 1 on page 14 for the first year of the Research Master (this is also year I of your Master of Science in Medicine). The programme for option 2 is described in table 2 on page 17 for the first year of the Research Master (this is year 3 of your Master of Science in Medicine). The MSc Health Sciences programme option 1 starting in 2012 has been changed slightly with respect to the previous year: students do not attend the course Clinical Epidemiology CE02, but attend the Erasmus Winter Programme in their first Research Master year. Students who have chosen option 1 and started in 2011 (preliminary programme in 2010), attend the course Clinical Epidemiology (CE02) in their second year instead of the Erasmus Winter Programme in their first year (see page 15). Erasmus Summer Programme no 2 takes place during the summer holidays. Research Seminars run parallel to the medical curriculum. Health Sciences students receive a seminar booklet in which they can register their seminars. Clinical Research students can register their seminars in their Personal Education Programme (PEP), see chapter 5 for details. To tailor the programme of your choice to your interests and professional needs, you may select advanced elective courses (between February and June) organized by NIHES. In the schedules on page 14, 15 and 17 you can find the number of ECTS you can choose. You have to choose courses in consultation with your advisor and/or tutor. A three week visit abroad to Harvard School of Public Health or Johns Hopkins University will be organized June and July. 3.2 Programme information Though most courses are given at Erasmus MC or at Erasmus University Woudestein campus in Rotterdam, some are given in Utrecht and some others in Amsterdam. For all courses in your programme except the courses in the Erasmus Summer Programme you will receive a letter containing details about the course location, the exact date and time of the lectures, date of the examination, relevant literature, etc.. You will receive this letter at least one week before the start of the course and receive access to your online course materials. 3.3 Course exemptions from courses of your Research Master programme Successful completion of KOW2 Ever thought of doing research? counts for an exemption of 2.8 ECTS in your Research Master programme. Students who did not attend KOW2 Ever thought of doing research? need to attend 2.8 ECTS elective courses in the research master programme. They may do so by attending courses in the Erasmus summer programme after their first research master year, and/or by attending advanced electives during the winter/spring period. Erasmus MC and Netherlands Institute for Health Sciences 10

13 Health Sciences & Clinical Research for Medical Students Successful completion of the minor Ever thought of doing research? results in exemption from the courses Study Design (CC01) and Biostatistical Methods I: Basic Principles 2 (CC02) in the Research Master programme (10 ECTS in total). By attending the Erasmus Summer Programme before the minor you will receive 4.2 ECTS in the Research Master programme. To be exempted from another course (or courses), you have to send a motivation and formal written request before 1 August 2012.Your request should include the following: 1. the titles of the NIHES courses you want to be exempted from and 2. per course you want to be exempted from: a list of course titles, including course descriptions and literature used, of the corresponding courses you already successfully passed in a previous programme. You should send your request to NIHES for the attention of Mrs Astrid Vrakking, p/a NIHES, Educational Support Center, (room Ee302). Please note that all information should be in English (or Dutch)! You can find detailed information on the courses you can be exempted from at the NIHES intranet: Course exemptions from courses of your Master of Science in Medicine For exemptions for the medical programme, a request should be handed in to the Examination Board of Medicine. It is the responsibility of the student to take care of these exemptions. Upon successful completion of all courses mentioned below, you can be exempted from thema Master 1a Methoden van klinisch en epidemiologisch onderzoek of your Master of Science in Medicine. For students who passed these courses after their first exam, NIHES will send a request to the Examination Board of Medicine. - Study Design (CC01); - Biostatistical Methods I: Basic Principles (CC02); - Clinical Trials (ESP14); - Principles of Genetic Epidemiology (ESP43); - Case-control Studies (ESP40); - History of Epidemiologic Ideas (ESP53) ): - Conceptual Foundation of Epidemiologic Study Design (ESP38): - Health Economics (ESP25) The courses above apply to students who started their Master of Science programme in For previous years check the Study Guide Upon completion of the research project for your Research Master programme, you may request for exemption of the research period in your medicine programme (keuzeonderzoek), as well as for the elective internship (keuze-coschap) 3.5 Course evaluations Evaluation will take place at the end of all courses. Please fill out these forms and hand them in on the last day of the course. Your input is very valuable and consistently helps us improve our courses. 3.6 Cancelling your participation in a course If you are unable to attend a course, please notify the NIHES programme officers at the Educational Support Center in writing at least two weeks before the start of the course. An administration fee of 50 will be charged for course cancellations made less than two weeks before the start of the course 3. 2 Biostatistical Methods I: Basic Principles (CC02) was previously known as Classical Methods to Data-analysis (CC02). 3 Please note that graduation is possible only when all invoices have been paid. 11 Study Guide

14 3.7 Confidential counsellor NIHES confidential counsellor Ed van Beeck, MD PhD Phone: Erasmus MC and Netherlands Institute for Health Sciences 12

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16 Table 1 - start 2012 option 1 Programme, option 1: Research Master and research before internships Year 2 Bachelor in Medicine Preliminary programme HS and CR ECTS Research Master Courses Research Total January/ February Year 3 Bachelor in Medicine August KOW2 Ever thought of doing research (EWP01 Erasmus Winter Programme)/ or 2,8 ECTS (10 days) electives in MSc programme Preliminary HS CR 3 weeks Erasmus Summer programme, 2,8 4,2 September-October October-August October-August Minor Ever thought of doing research ( CC01 and CC02) 10 Orientation research area Seminars total ECTS preliminary programme Year 1: Master in Medicine First year research master HS and CR August-August 16 Seminars (year 1) 3 August Courses Erasmus Summer Programme (3 weeks) 4,2 October/March: Theme 1.b the patient February Orientation research area (2 weeks) 2,8 February-March EWP: Clinical Epidemiology (4 weeks) 4,6 January-June Advanced elective courses (2 weeks) 2,8 March-April Development research protocol (6 weeks) 8,4 May-August Research period 1 (6 weeks) 8,4 June-July Courses Harvard/Johns Hopkins (3 weeks) 4,2 Year 2: Master in Medicine Second year MSc HS and CR August-August 16 Seminars (Year 2) 3 November-December SC07 Scientific writing in English for Publication 2 November-December EP03 Modern statistical Methods (3 weeks) For HS students compulsory, for CR students elective, this course may be replaced by 15 days of 4,2-4,3 electives January-February Advanced topics in Clinical Research (3 weeks Erasmus Winter Programme with exams) 5,4 January-June Advanced elective courses (2 weeks) 2,8 Throughout the year Research period year 2 (33 weeks), (including presentation and symposium) 47,2 Internships Year 3 and 4: Master in Medicine Internships until April Total ECTS Research Master 53,2 66,8 120 Erasmus MC and Netherlands Institute for Health Sciences 14

17 Health Sciences & Clinical Research for Medical Students Table 2 - start 2011 option 1 Programme, option 1: Research Master and research before internships Year 2 Bachelor in Medicine Preliminary programme HS and CR ECTS Research Master Courses Research Total January/ February Year 3 Bachelor in Medicine August KOW2 Ever thought of doing research (EWP01 Erasmus Winter Programme)/ or 2,8 ECTS (10 days) electives in MSc programme Preliminary HS CR 3 weeks Erasmus Summer programme, 2,8 4,2 September/October October-August October-August Minor Ever thought of doing research ( CC01 and CC02) 10 Orientation research area Seminars total ECTS preliminary programme Year 1: Master in Medicine First year research master HS and CR August-August 16 Seminars (year 1) 3 August Courses Erasmus Summer Programme (3 weeks) 4,2 September Orientation research area (3 weeks) 4,2 October/March: Theme 1.b the patient January to June Advanced elective courses 2,8 March/April Development research protocol (4 weeks) 5,7 May-August Research period 1 (12 weeks) 16,8 June/July Courses Harvard/Johns Hopkins (3 weeks) 4,2 Year 2: Master in Medicine Second year MSc HS and CR August-August 16 Seminars (Year 2) 3 October CE02 Clinical Epidemiology (4 weeks) 5,7 November/December SC07 Scientific Writing in english for Publication 2 November/December EP03 Modern statistical Methods (3 weeks) For HS students compulsory, for CR students elective, this course may be replaced by 15 days of 4,2-4,3 electives January/ February Advanced topics in Clinical Research (3 weeks Erasmus Winter Programme with exams) 5,4 January to June Advanced elective courses (2 weeks) 2,8 Throughout the year Research period year 2 (29 weeks), (including presentation and symposium) 41 Internships Year 3 and 4: Master in Medicine Internships until April Total ECTS Research Master 54,3 65, Study Guide

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19 Health Sciences & Clinical Research for Medical Students Table 3 option 2 Programme, option 2: Research Master and research after internships Year 2 Bachelor in Medicine Preliminary HS and CR ECTS Research Master Courses Research Total January-February Year 3 Bachelor in Medicine KOW2 Ever thought of doing research (EWP01 Erasmus Winter Programme)/ or 2,8 ECTS (10 days) electives in MSc programme Preliminary HS CR 2,8 August 3 weeks Erasmus Summer programme, 4,2 September-October October-August October-August Minor Ever thought of doing research ( CC01 and CC02) Orientation research area Seminars 10 total ECTS preliminary programme Year 1: Master in Medicine First year research master HS and CR August-August 16 Seminars (year 1) 3 August Courses Erasmus Summer Programme (3 weeks) 4,2 October-February: Theme 1.b The Patient February-March Internships Year 2: Master in Medicine Erasmus Winter Programme: Clinical Epidemiology (4 weeks) 4,6 Internships Year 3: Master in Medicine Internships September/December Year 1 research Master MSc HS and CR (continued) January Orientation research area (2 weeks) 2,8 January -February Development research protocol (6 weeks) 8,4 January -June Advanced elective courses (2 weeks) 2,8 February - Mar Advanced topics in Clinical Research (three weeks Erasmus Winter Programme) 5,4 April-August Research period (16 weeks) 19,6 June-July Courses Harvard/Johns Hopkins (3 weeks) 4,2 Year 4: Master in Medicine Year 2 research Master HS and CR August-August 16 Seminars (Year 2) 3 November-December Scientific Writing in English for Publication (SC07) 2,0 November-December EP03 Modern statistical Methods (3 weeks) For HS students compulsory, for CR students elective 4,2-4,3 and may be replaced by 15 days of other electives January-June Advanced elective courses (2 weeks) 2,8 Throughout the year Research period year 2 (28 weeks), (including presentation and symposium) 36,0 Total ECTS Research Master 53,2 66, Study Guide

20 4. Research project & time table Research Master Health Sciences In this chapter an overview of the courses and information on the research project of the Research Master in Health Sciences for Master students in Medicine is given. Chapter 5 discusses the Research Master Clinical Research. The following pages include the timetables for Option 1 of the Research Master in Health Sciences programme. Please note that the programme is subject to change. You are advised to regularly check for up-to-date course information. Students who are going to do their research project at the Genetic Epidemiology department will have to attend specific genetic courses during the Erasmus Summer Programme, and in spring and fall. The specific programme outline will be determined together with the Programme Coordinator, Astrid Vrakking. 4.1 Research project An important part of the programme is dedicated to your research project. The programme covers a broad and varied range of research, from major neurological and cardiovascular diseases to the endocrinological determinants of diseases; from paediatric studies to end-of-life decisions in medical practice; and from the social determinants of health and disease to the side effects of drugs. Research areas for students Clinical Research differ form those for students Health Sciences. The research areas and research groups of both programmes are mentioned in our brochure Research Themes: Research Master Programmes Health Sciences and Clinical Research. This brochure is available on the NIHES website. You will work on your research project under the guidance and supervision of the personal tutor to whom, as described in the next paragraph, you are assigned at the start of your programme. All tutors are senior faculty members at the Erasmus University. Each has considerable experience in one or more specific research subjects. On the basis of your research ambitions, the selection committee will choose a field of research and a tutor. The tutor will receive your curriculum vitae. From that point on, it is up to your tutor and you to arrange your further collaboration. The primary tasks of the tutor are: to support and supervise the student during the research phase; to keep track of the content of the student s training programme; to meet the student for at least an hour at least once every two weeks; to arrange for the student to be provided with a desk and computer, usually at the tutor s own department; to arrange that his or her student receives all the necessary computer software, i.e. in addition to the standard software available (see below); to monitor and report on the student's progress and results; to assess the student's research project. Practical research As soon as you and your tutor have decided on the topic for a research project, you will start working on your research project. You will be required to formulate a research proposal and design a study. While it is possible for you to collect and analyse data yourself, in most cases you will carry out your project using existing data available at the department. You will work closely together with the research group at your tutor s department, and have full access to the computer facilities available for data management and analysis. As stated above, you will regularly meet with your tutor, especially in the beginning. The research training starts with formulating a research question and writing a research proposal. This proposal should include, among other things, the research objectives, the study design, the data-collection and the data-analysis procedure, and your time schedule. The research topic you choose, will determine the department or research group you will be assigned to and where you will be carrying out your research project. You will start working on your research project after approval of your proposal by your personal tutor. You will write a scientific paper under the guidance of your tutor. Erasmus MC and Netherlands Institute for Health Sciences 18

21 Health Sciences & Clinical Research for Medical Students Your research proposal As a first-year student,you have to write a research proposal in collaboration with your tutor. If you are a first year Research master student, following option 1, you should hand in your proposal, signed for approval by your tutor, to the NIHES Administration, Educational Support Center (Fe209) for the attention of Mrs Astrid Vrakking before Tuesday 15 May Please note that this deadline will be strictly maintained. The research proposal should comprise of a maximum of 4 pages (A4, single-spaced text) and contain the following information: objectives; project group; study design; data-collection procedure; data-analysis procedure; time schedule. Presenting your research Symposium Each year, a symposium for medical students who are planning to finish their research project for the Research Master Health Sciences or Clinical Research will be organized. Students have to present their research project. Tutors and advisors are invited too. The date will be announced. Research department Students are also required to present their research project to their tutor s research group: the tutor needs to confirm, in writing, that the presentation took place. Please note that it is your responsibility to ensure that we receive this confirmation no later than 5 weeks before your graduation. The confirmation should be addressed to the NIHES Administration, Educational Support Center (Fe209) for the attention of Mrs Astrid Vrakking or via to [email protected]. Your thesis Handing in your thesis You are required to write and hand in one draft of a research paper that is submittable to an international peer reviewed scientific journal. Your paper should be approved and signed by your tutor. The deadline for submitting the paper is 5 weeks before the graduation ceremony (See also chapter 7). Your research project may eventually lead to your submission of a paper (i.e. an article) to an international peer reviewed scientific journal. Publishing and presenting your research project Once your research paper has been published, a copy should be sent to the NIHES Administration, Educational Support Center (Fe209). Furthermore, Health Sciences students must always mention or refer to NIHES when presenting or publishing their research findings. 19 Study Guide

22 Time table Research Master Health Sciences for Master students in Medicine, option 1 and option 2 4 See also Table 1 on page 14 and Table 3 on page 15. Start 2012 First year Summer 2012 Introductory courses Erasmus Summer Programme ECTS Dates Time Location Clinical Trials (ESP14) Aug Daily from 8.45 to hours Woudestein, Rotterdam Principles of Genetic Epidemiology (ESP43) Aug Daily from to hours Woudestein, Rotterdam Case Control Studies (ESP40) Aug Daily from 8.45 to hours Woudestein, Rotterdam History of Epidemiologic Ideas Aug Daily from to hours Woudestein, Rotterdam Conceptual Foundation of Epidemiologic Study Design (ESP38) Aug Daily from 8.45 to hours Woudestein, Rotterdam Health Ecenomics (ESP25) Aug Daily from to hours Woudestein, Rotterdam CHRISTMAS BREAK 22 December January 2013 Winter / Spring 2013 Advanced courses ECTS Dates Examination/Re-exam Location Intervention Research and Clinical Trials (EWP04) Feb 1 Mar 22 Mar, re-exam: 8 May Erasmus MC Diagnostic Research (EWP05) Mar Assignment(s) during course Erasmus MC Prognostic Research (EWP16) Mar 22 Mar, re-exam: 8 May Erasmus MC Advanced Topics in Decision Making in Medicine (EWP02) Mar Assignment(s) during course Erasmus MC Advanced elective courses 5.6 to 7.2 Jan Jun You may select 20 to 25 days days of elective courses. (If you have followed KOW2 Ever thought of doing research in your Bachelor Medicine, you need to follow 10 to 15 days (2.8 to 4.2 ECTS) Harvard/Johns Hopkins 4.2 Jun - Jul USA (3 weeks) 4 Option 2 students, who started in 2012, attend this programme until the Erasmus Winter Programme in Erasmus MC and Netherlands Institute for Health Sciences 20

23 Health Sciences & Clinical Research for Medical Students Research Orientation research area 2.8 February 2 weeks Development research protocol 8.4 Mar - May 6 weeks Research period May Aug 12 weeks Advanced courses - Seminars You are required to attend in total 32 seminars as part of your programme, obtaining 6 ECTS. 21 Study Guide

24 Time table Research Master Health Sciences for Master students in Medicine option 1 See also Table 2 on page 15. Start 2011 Second year Fall 2012 Programme specific courses and skils courses ECTS Dates Examination/Re-exam Location Clinical Epidemiology (CE02) Oct 16 Nov 16 Nov Re-exam: 18 Jan 2013 Erasmus MC, Rotterdam Biostatistical Methods II: classical regression models (EP03) Dec 21 Dec Re-exam: 8 Feb 2013 Erasmus MC, Rotterdam Scientific writing in English for Publication (SC07) and 28 Nov and 12 Dec Attendance and assignments. Erasmus MC, Rotterdam Presentation research project at mini symposium Nov/Dec 2012 CHRISTMAS BREAK 22 December January 2013 Winter / Spring 2013 Advanced courses and skills courses ECTS Dates Examination/Re-exam Location Pharmaco-epidemiology and Drug Safety (EWP03) Feb 1 Mar 22 Feb, re-exam: 8 May Erasmus MC Advanced Topics in Clinical Trials (EWP10) Mar 22 Feb, re-exam: 8 May Erasmus MC Advanced Analysis of Prognosis Studies (EWP13) Mar 22 Feb, re-exam: 8 May Erasmus MC Principles of Epidemiologic Data-analysis (EWP25) Mar 15 Mar, re-exam: 8 May Erasmus MC Advanced elective courses 2.8 Jan - Jun You may select 10 to 15 days days of elective courses Research Research period 2 Throughout the year 29 weeks Advanced courses - Seminars You are required to attend in total 32 seminars as part of your programme, obtaining 6 ECTS. Graduation Information about the formal completion of your programme and the graduation ceremony is t.b.a.. Erasmus MC and Netherlands Institute for Health Sciences 22

25 Health Sciences & Clinical Research for Medical Students 5. Research project & time table Research Master Clinical Research In this chapter an overview of the courses and information on research project of the Research Master in Clinical Research for Master students in Medicine is given. In chapter 4, information on the Research Master Health Sciences can be found. 5.1 Research project An important part of the programme is dedicated to your research project. The programme covers a broad and varied range of research, from major neurological and cardiovascular diseases to the endocrinological determinants of diseases; from paediatric studies to end-of-life decisions in medical practice; and from the social determinants of health and disease to the side effects of drugs. Research areas for students Clinical Research differ form those for students Health Sciences. The research areas and research groups of both programmes are mentioned in our brochure Research Themes: Research Master Programmes Health Sciences and Clinical Research This brochure is available on the NIHES website. Advisory Board Clinical Research Advisory Board Clinical Research consists of the following persons: Prof. A.J. van der Lely, MD PhD, Endocrinology Prof. H. Boersma, ir., PhD, Thorax Epidemiology Prof. H.A. Drexhage, MD, PhD, Immunology Prof. H. Hooijkaas, MD, PhD, Immunology L.J. Hofland, MD, PhD, Endocrinology Prof. J.F. Lange, MD, PhD, Surgery Prof. M.P. Peppelenbosch, MD, PhD, Gastroenterology & Hepatology Prof. I.P. Touw, MD, PhD, Hematology A.J.M. Verhoeven, PhD, Internal Medicine The Advisory Board Clinical Research guides the study progress of the Clinical Research students. The Board meets every few months. Furthermore, members of the Board are part of the defence committee. The selection committee will choose an advisor of the Advisory Board Clinical Research based on your research ambitions. The advisor will receive your curriculum vitae. From that point on, it is up to your advisor and you to search for a suitable research project and tutor. When you agree on a research project and tutor, please inform your NIHES programme officer at [email protected]. Primary tasks of the advisor are: to find a tutor on the basis of the students preferences and possibilities of the research group/department; to keep informed about the study progress; to answer questions and assist the student with solving problems that are not directly connected to the research project and tasks of the tutor; to be present at the symposium. Personal Education Programme (PEP) At the beginning of your Research Master you will receive a Personal Educational Plan, which is meant for you to administrate your programme. The following topics are covered in the PEP: meetings with your advisor Clinical Research and tutor, planning elective courses and performed elective courses and research seminars. Tutor You will work on your research project under the guidance and supervision of the personal tutor to whom you are assigned in discussion with your advisor. All tutors are senior faculty members at the Erasmus University. Each has considerable experience in one or more specific research subjects. The primary tasks of the tutor are: to support and supervise the student during the research phase; to keep track of the content of the student s training programme; to meet the student for at least an hour at least once every two weeks; to arrange for the student to be provided with a desk and computer, usually at the tutor s own department; 23 Study Guide

26 to arrange that his or her student receives all the necessary computer software, i.e. in addition to the standard software available (see below); to monitor and report on the student's progress and results; to report the research progress to the advisor of the Advisory Board Clinical Research; to assess the student's research project; to find an independent reviewer, preferably outside the Netherlands, to assess the final paper of the students research project; to be present at the final defence meeting of the student. Practical research As soon as you and your tutor have decided on the topic for a research project, you will start working on your research project. You will be required to formulate a research proposal and design a study. While it is possible for you to collect and analyse data yourself, in most cases you will carry out your project using existing data available at the department. You will work closely together with the research group at your tutor s department, and have full access to the computer facilities available for data management and analysis. As stated in paragraph 6.2, you will regularly meet with your tutor, especially in the beginning. The research training starts with formulating a research question and writing a research proposal. This proposal should include, among other things, the research objectives, the study design, the data-collection and the data-analysis procedure, and your time schedule. The research topic you choose, will determine the department or research group you will be assigned to and where you will be carrying out your research project. You will start working on your research project after approval of your proposal by your personal tutor and advisor. You will write a scientific paper under the guidance of your tutor. Your research proposal As a first-year student following option 1, you have to write a research proposal in collaboration with your tutor. You should hand in your proposal, signed for approval by your tutor, to the NIHES Administration, Educational Support Center (Fe209) for the attention of Mrs Astrid Vrakking before Friday 15 May Please note that this deadline will be strictly maintained. The research proposal should comprise of a maximum of 4 pages (A4, single-spaced text) and contain the following information: objectives; project group; study design; data-collection procedure; data-analysis procedure; time schedule. Presenting your research Presenting your research proposal Approximately month after handing in your research proposal, you have to present it to members of the Advisory Board Clinical Research. More information will be announced. Symposium Each year in November, a symposium for medical students who attend the Research Master of Health Sciences and Clinical Research will be organized. Students who are in the third year of their Master have to present their research project. Tutors and advisors are invited too. The date will be announced. Research department Students are also required to present their research project to theirs tutor s research group: the tutor needs to confirm, in writing, that the presentation took place. Please note that it is your responsibility to ensure that we receive this confirmation no later than five weeks before your graduation. The confirmation should be addressed to the NIHES Administration, Educational Support Center (Fe209) for the attention of Mrs Astrid Vrakking or via to [email protected]. Erasmus MC and Netherlands Institute for Health Sciences 24

27 Health Sciences & Clinical Research for Medical Students Your thesis Handing in your thesis You are required to write and hand in one research paper that is submittable to an international peer reviewed scientific journal to NIHES. Your paper should be approved and signed by your tutor. The deadline for submitting the paper is dependent of your defence. It will be announced as soon as your defence date is determined. Your research project will eventually lead to your submission of a paper (i.e. an article) to an international scientific journal. Defence of the research project You also have to defend your research paper in front of a committee with members of the Advisory Board Clinical Research and your tutor. Three dates will be announced for which you can sign in aligning with your tutor. Publishing and presenting your research project Once your article has been published, a copy should be sent to the NIHES Administration, Educational Support Center (Fe209). Furthermore, Clinical Research students must always mention or refer to Erasmus MC when presenting or publishing their research findings. Time table Research Master in Clinical Research The following pages include the timetables for the first and second year BaMa students of the Research Master in Clinical research programme. Please note that the programme is subject to change. You are advised to regularly check for up-to-date course information. 25 Study Guide

28 Time table Research Master Clinical Research for Master students in Medicine option 1 See also Table 1 on page 14. Start 2012 First year Summer 2012 Introductory courses Erasmus Summer Programme ECTS Dates Time Location Clinical Trials (ESP14) Aug Daily from 8.45 to hours Woudestein, Rotterdam Principles of Genetic Epidemiology (ESP43) Aug Daily from to hours Woudestein, Rotterdam Case Control Studies (ESP40) Aug Daily from 8.45 to hours Woudestein, Rotterdam History of Epidemiologic Ideas Aug Daily from to hours Woudestein, Rotterdam Conceptual Foundation of Epidemiologic Study Design (ESP38) Aug Daily from 8.45 to hours Woudestein, Rotterdam Health Ecenomics (ESP25) Aug Daily from to hours Woudestein, Rotterdam CHRISTMAS BREAK 22 December January 2013 Winter / Spring 2013 Advanced courses ECTS Dates Examination/Re-exam Location Intervention Research and Clinical Trials (EWP04) Feb 1 Mar 22 Feb, re-exam: 8 May Erasmus MC Diagnostic Research (EWP05) Mar Assignment(s) during course Erasmus MC Prognostic Research (EWP16) Mar 22 Feb, re-exam: 8 May Erasmus MC Advanced Topics in Decision Making in Medicine (EWP02) Mar Assignment(s) during course Erasmus MC Advanced elective courses 5.6 to 7.2 Jan Jun You may select 20 to 25 days days of elective courses in total. (If you have followed KOW2 Ever thought of doing research in your Bachelor Medicine, you need to follow 10 to 15 days (2.8 to 4.2 ECTS) Harvard/Johns Hopkins 4.2 Jun - Jul USA (3 weeks) Erasmus MC and Netherlands Institute for Health Sciences 26

29 Health Sciences & Clinical Research for Medical Students Research Orientation research area 2.8 February 2 weeks Development research protocol 8.4 Mar - May 6 weeks Research period May Aug 12 weeks Advanced courses - Seminars You are required to attend in total 32 seminars as part of your programme, obtaining 6 ECTS. 27 Study Guide

30 Time table Research Master Clinical Researhc for Master students in Medicine option 1 See also Table 2 on page 15. Start 2011 Second year Fall 2012 Programme specific courses and skils courses ECTS Dates Examination/Re-exam Location Clinical Epidemiology (CE02) Oct 16 Nov 16 Nov Re-exam: 18 Jan 2013 Erasmus MC, Rotterdam Optional:Biostatistical Methods II: classical regression Dec 21 Dec Re-exam: 8 Feb 2013 Erasmus MC, Rotterdam models (EP03), for Clinical Research students this is an elective and may be replaced by 15 days of other electives 4.3 Scientific writing in English for Publication (SC07) and 28 Nov and 12 Dec Attendance and assignments. Erasmus MC, Rotterdam Presentation research project at mini symposium Nov/Dec 2012 CHRISTMAS BREAK 22 December January 2013 Winter / Spring 2013 Advanced courses and skills courses ECTS Dates Examination/Re-exam Location Pharmaco-epidemiology and Drug Safety (EWP03) Feb 1 Mar 22 Feb, re-exam: 8 May Erasmus MC Advanced Topics in Clinical Trials (EWP10) Mar 22 Feb, re-exam: 8 May Erasmus MC Advanced Analysis of Prognosis Studies (EWP13) Mar 22 Feb, re-exam: 8 May Erasmus MC Principles of Epidemiologic Data-analysis (EWP25) Mar 15 Mar, re-exam: 8 May Erasmus MC Advanced elective courses 2.8 Jan - Jun You may select 10 to 15 days days of elective courses Research Research period 2 Throughout the year 29 weeks Erasmus MC and Netherlands Institute for Health Sciences 28

31 Health Sciences & Clinical Research for Medical Students Advanced courses - Seminars You are required to attend in total 32 seminars as part of your programme, obtaining 6 ECTS. Graduation Information about the formal completion of your programme and the graduation ceremony is t.b.a.. 29 Study Guide

32 6. Examination Procedure and Rules TER and Examination Board You can find the examination procedures and rules in the Teaching and Examination Regulations (TER) Research Master Programmes on the NIHES intranet: http//nihes.nl/intranet. Details on the Examination Board can also be found on the NIHES intranet. 6.2 Attainment targets Training With the exception of the skills courses and most elective courses all courses in the core curriculum culminate in an examination. For a candidate to pass an examination he or she may not score less than satisfactory, i.e. a grade lower than 5.5. Skills courses and advanced elective courses There are no examinations for the skills courses or most electives. Instead, a pass grade is required. To obtain this, students have to attend the courses. Only then will the course be stated on your list of grades. A student is only allowed to be absent from a course for 20% maximum if a motivated request is granted by one of the programme officers or programme coordinators of NIHES. Research The research project has to culminate in a research paper; the entire paper, including all parts or paragraphs, has to be ready for submission to an international English-language scientific journal. The journal has to have an impact factor and a good reputation in its field. The conventions of The Journal of American Medical Association (JAMA) apply as author's rules: this means that the student is usually named as first author and the tutor as second in the research paper. The names should also be stated of 1. the institute where the research was carried out, 2. the Netherlands Institute for Health Sciences, and, if applicable, 3. the student's home institute. In the event of problems during the research phase, student and tutor should both report to one of the programme coordinators no later than the March before graduation. All tutors assess their students on the basis of the student s commitment and motivation, and on the knowledge and creativity they have demonstrated during the research period. Final assessment of the research paper is expressed as one of the following levels: Outstanding (9-10) Excellent (8-8.9) Very Good (7-7.9) Good (6-6.9) Satisfactory ( ) Unsatisfactory (4-5.4) Poor (1-3.9) No later than the beginning of August in the year of graduation, the tutor will write and submit the assessment report in which he or she gives formal permission for a degree to be awarded to his or her student. If the outcome is insufficient (less than 5.5), the student will not be able to graduate. The paper has to be assessed by the director. 6.3 Students overall rights and duties The following rights and duties apply to all the students. Each student may start his or her research project only when all compulsory courses have been passed (programme coordinators alone are authorized to decide on deviations from this rule). 5 For full details, see the Teaching and Examination Rules. Information is available at the NIHES administrative office, Educational Support Center or at Masters Erasmus MC and Netherlands Institute for Health Sciences 30

33 Health Sciences & Clinical Research for Medical Students Each student is expected to show maximum application and commitment. Each student must guarantee strict confidentiality with regard to information obtained during the research phase (research data, draft articles, etc.). Each student should determine, together with his or her tutor, and no later than December, the software packages necessary for the research project. Each student is required to produce a research paper (or more, according to the programme in which he or she is enrolled), which is to be assessed and approved by the tutor. Each student will decide in consultation with the tutor on the journal to which the article will be submitted. Each student should always provide the NIHES administration, Educational Support Center with a copy of the published article or articles. Furthermore: A student may present his or her research findings at a congress or other event only after careful consultation with his or her tutor. (Please note that participation fees and other related expenses cannot be recovered from NIHES) A student Health Sciences must always mention or refer to NIHES when presenting or publishing his or her research findings. A student Clinical Research must always mention or refer to Erasmus MC when presenting or publishing his or her research findings. 31 Study Guide

34 7. Graduation 7.1 Graduation ceremony Graduating and the graduation ceremony for medical students are subject to change. In April/May you will automatically receive full details about the graduation ceremony including a registration form. 7.2 NIHES Award and Erasmus MC MSc CR Award Each year, during the Graduation Ceremony, two awards are presented to the Research Master student Health Sciences and the Research master student Clinical Research who is first author of the best paper (or draft paper) written under the guidance of a NIHES/Erasmus MC tutor in the current academic year. Two awards are given, each consisting of a certificate and 500. All tutors and scientific personnel involved in the Research Master programme in Health Sciences may nominate one or more students they believe to be eligible for a NIHES Award. The best will be selected by the Award Committee, which is chaired by Professor Hofman, Science Director of the Netherlands Institute for Health Sciences. For the Erasmus MC MSc CR Award the procedure is likewise. All tutors and scientific personnel involved in the Research Master programme Clinical Research nominate one or more students they believe to be eligible for Erasmus MC MSc CR Award. The best will be selected by the Award Committee, which is chaired by Professor Van der Lelij, Programme Director of the Research Master Clinical Research. Erasmus MC and Netherlands Institute for Health Sciences 32

35 Health Sciences & Clinical Research for Medical Students 8. After graduation 8.1 Stay in touch! NIHES and the Erasmus MC like to keep track of their alumni. You will regularly receive a questionnaire to keep us updated about your address and career. We would appreciate when you fill in this questionnaire. You are also welcome to let us know how you re doing and send your changes of address (including ) to [email protected]. and our best wishes in your future career! 33 Study Guide

36 Annex I 1.1 NIHES Administration The Team Graduate School of the Educational Support Center takes care of the NIHES administration. It is situated on the third floor of the Faculty-building (Ee) of Erasmus MC. Erasmus MC and its medical faculty are located on the Hoboken campus of Erasmus University Rotterdam. The other Erasmus University faculties are located on the Woudestein campus. Visiting address Postal address Educational Support Center (DCO) Dr. Molewaterplein 50, Room Fe GE Rotterdam The Netherlands Phone: +31 (0) Fax: +31 (0) [email protected] NIHES Educational Support Center (DCO), Room Fe209 PO Box CA Rotterdam The Netherlands 1.2 NIHES office hours The NIHES Administration at the Educational Support Center is open on weekdays from 9.00 to hours. You can also make an appointment to speak to one of the programme officers. The programme coordinators and advisors education are available by appointment. For contact details see Annex I. 1.3 NIHES intranet Throughout the year, important course information, updates, announcements, and news on events, etc. is available on the NIHES intranet: To access the intranet you need a username and password, which were sent out by at the beginning of August. If you did not receive this notification, please contact the NIHES administration at the Educational Support Center. 1.4 Staff Health Sciences & Clinical Research Programme Director Health Sciences Managing Director Prof. Albert Hofman, MD PhD Available by appointment Room: Ee 2175 Phone: [email protected] Koos Lubbe, MSc Available by appointment Room: Ae 334 Phone: [email protected] Chairpersons Health Sciences Prof. Albert Hofman, MD PhD Prof. Cornelia van Duijn, PhD Prof. Myriam Hunink, MD PhD Prof. Alex Burdorf, Ir PhD Prof. Emmanuel Lesaffre, PhD Erasmus MC and Netherlands Institute for Health Sciences 34

37 Health Sciences & Clinical Research for Medical Students Programme Director Clinical Research Prof. Aart Jan van der Lely, MD PhD Available by appointment Room: D-437 Phone: Advisory Board Clinical Research Prof. A.J. van der Lely, MD PhD, Endocrinology Prof. H. Boersma, ir., PhD, Thorax Epidemiology Prof. H.A. Drexhage, MD, PhD, Immunology Prof. H. Hooijkaas, MD, PhD, Immunology L.J. Hofland, MD, PhD, Endocrinology Prof. J.F. Lange, MD, PhD, Surgery Prof. M.P. Peppelenbosch, MD, PhD, Gastroenterology & Hepatology Prof. I.P. Touw, MD, PhD, Hematology A.J.M. Verhoeven, PhD, Internal Medicine Coordinators Annet Bout-Tellegen, PhD Available by appointment on Mondays, Tuesdays and Thursdays Room: Ae 314 Phone: Mrs. Bout is coordinator of NIHES. Astrid Vrakking, PhD Available by appointment on weekdays except Friday Room: Ae 328 Phone: E.mail: Mrs Vrakking is programme coordinator student affairs. Advisors Education Monique Nuijten, MSc Available by appointment on Tuesdays, Wednesdays and Fridays Room: Ae 311 Phone: E.mail: Mrs. Nuijten monitors students progress in their studies and is the contact person for nonmedical students. Neeltje Schrofer, MSc Available by appointment on Tuesdays, Thursdays and Fridays Room: Ae 311 Phone: Mrs. Schrofer takes care of the planning, quality and communication of the programmes and courses. Coordinator Team Graduate School Quarda Kassrioui Available on weekdays, except Wednesday Educational Support Center Room: Fe 209 Phone: Study Guide

38 Programme Officers Elena O Neill Available on weekdays, except Tuesday Educational Support Center, Team Graduate School Room: Fe 209 Phone: [email protected] Mariska Guijt Available on weekdays, except Thursday Educational Support Center, Team Graduate School Room: Fe 209 Phone: [email protected] Willeke Burcksen Available on weekdays, except Wednesday Educational Support Center, Team Graduate School Room: Fe 209 Phone: [email protected] The programme officers are part of Team Graduate School of the Educational Support Center (DCO), room Fe 209. They take care of the day-to-day organization of the study programmes, courses, graduations, etc. They carry out their activities in close collaboration with the programme coordinators, advisors education, course coordinators, lecturers and other third parties involved. Students can contact Mrs O Neill, or Mariska Guijt with questions relating to their study programme, courses, registration, visa, accommodation and fellowships. NIHES Communication and Marketing Peter Zimmermann Available on weekdays except Friday Room: Ae 326 Phone: [email protected] NIHES Financial Affairs Lenie Kroon-Pelser Available on Tuesdays, Thursdays and Fridays Room: Ae 336 Phone: [email protected] Erasmus MC and Netherlands Institute for Health Sciences 36

39 Health Sciences & Clinical Research for Medical Students Annex III: Course descriptions NIHES courses Annex III: Course descriptions NIHES courses...37 Course names in alphabetical order CC01: Study Design CC02: Biostatistical Methods I: Basic Principles CC02A: Biostatistical Methods I: Basic Principles Part A CE02: Clinical Epidemiology CE05: Epidemiology of Infectious Diseases CE08: Repeated Measurements in Clinical Studies CE09: Bayesian Statistics EP02: Methodologic Topics in Epidemiologic Research EP03: Biostatistical Methods II: Classical Regression Models EP12: Psychiatric Epidemiology EP13: Cancer Epidemiology EP16: Missing values in Clinical Research...44 EP18: Analysis of Growth Data EP19: Women's Health ESP01: Principles of Research in Medicine and Epidemiology ESP03: Introduction to Data-analysis ESP04: Clinical Decision Analysis ESP09: Regression Analysis ESP10: Methods of Clinical Research...47 ESP11: Methods of Public Health Research ESP14: Clinical Trials ESP15: Topics in Meta-analysis ESP21: Pharmaco-epidemiology...49 ESP25: Health Economics ESP28: Survival Analysis ESP29: Genome Wide Association Analysis ESP38: Conceptual Foundation of Epidemiologic Study Design ESP39: Cohort Studies ESP40: Case-control Studies ESP41: Introduction to Global Public Health ESP42: Methods of Health Services Research ESP43: Principles of Genetic Epidemiology ESP45: Primary and Secondary Prevention Research ESP48: Causal Inference ESP53: History of Epidemiologic Ideas...54 ESP57: Genomics in Molecular Medicine ESP59: Demography of Ageing...54 ESP60: The Why and How of Readable Articles ESP61: Social Epidemiology ESP62: Markers and Prognostic Research ESP63: Masterclass: Advances in Genomics Research ESP64: Masterclass: Advances in Epidemiologic Analysis ESP67: Masterclass: Epidemiological Research An Avantgarde Introduction EWP01: Introduction to Clinical Research EWP02: Advanced Topics in Decision Making in Medicine EWP03: Pharmaco-epidemiology and Drug Safety EWP04: Intervention Research and Clinical Trials EWP05: Diagnostic Research EWP10: Advanced Topics in Clinical Trials EWP11: Introduction to Clinical and Public Health Genomics EWP13: Advanced Analysis of Prognosis Studies EWP16: Prognostic Research EWP22: Biostatistics for clinicians EWP23: Regression analysis for clinicians...60 EWP24: Survival analysis for clinicians EWP25: Principles of Epidemiologic Data Analysis GE02: Genetic-epidemiologic Research Methods GE03: Advances in Genome-Wide Association Studies of Complex Genetic Disorders GE05: Family-based Genetic Analysis GE10: Mendelian Randomization...62 GE13: Next generation sequencing course HS02a: Analysis of Population Health...63 HS02b: Analysis of Determinants HS02c: Intervention Development and Evaluation HS03a: International Comparison of Health Care Systems HS04: Medical Demography HS05: Planning and Evaluation of Screening HS09: Maternal and Child Health Study Guide

40 HS11: Quality of Life Measurement...66 HS15: Health Services: Research and Practice HS17: Ethnicity, Health and Health Care HS18: From problem to solution in public health MP05: Preventing Failed Interventions in Behavioral Research PU03: Site Visit to the Municipal Health Service Rotterdam PU04: Integration module PU06: Public Health in Low and Middle Income Countries SC01: English Language SC02: Introduction to Medical Writing SC07: Scientific Writing in English for Publication SC09: Linux for Scientists SC17: Courses for the Quantitive Researcher Erasmus MC and Netherlands Institute for Health Sciences 38

41 Health Sciences & Clinical Research for Medical Students Course names in alphabetical order Course name Course code Course name Course code Advanced Analysis of Prognosis Studies EWP13 Introduction to Data-analysis ESP03 Advanced Topics in Clinical Trials EWP10 Introduction to Medical Writing SC02 Advanced Topics in Decision-making in Medicine EWP02 Introduction to Decision-Making in Medi- ESP49 Advances in Epidemiologic Analysis ESP64 Introduction to Public Health ESP41 Advances in Genomics Research ESP63 Large-scale Multicenter Studies ESP58 Advances in Population-based Studies of Complex Genetic Disorders GE03 Linux for Scientists SC09 Analysis of Determinants HS02B Markers and Prognostic Research ESP62 Analysis of Population Health HS02A Maternal and Child Health HS09 Bayesian Statistics CE09 Medical Demography HS04 Biostatistics for clinicians EWP22 Mendelian Randomization GE10 Biostatistical Methods I: Basic Principles CC02 Methodologic Topics in Epidemiology Re- EP02 Biostatistical Methods I: Basic Principles Part A CC02A Methods of Clinical Research ESP10 Biostatistical Methods II: Classical Regression Models EP03 Methods of Health Services Research ESP42 Cancer Epidemiology EP13 Methods of Public Health Research ESP11 Case-control Studies ESP40 Next generation sequencing course GE13 Causal Inference ESP48 Pharmaco-epidemiology ESP21 Clinical Decision Analysis ESP04 Pharmaco-epidemiology and Drug Safety EWP03 Clinical Epidemiology CE02 Planning and Evaluation of Screening HS05 Clinical Trials ESP14 Preventing Failed Interventions in Behav- MP05 Cohort Studies ESP39 Principles of Epidemiologic Data Analysis EWP25 Conceptual Foundation of Epidemiologic Study Design ESP38 Principles of Genetic Epidemiology ESP43 Courses for the Quantitative Researcher SC17 Principles of Research in Medicine ESP01 Demography of aging ESP59 Primary and Secondary Prevention Re- ESP45 Diagnostic Research EWP05 Prognosis Research EWP16 English Language SC01 Public Health in Low and Middle Income PU06 Ethical, Legal and Societal Aspects of Genomics GE09 Psychiatric Epidemiology EP12 Ethnicity, Health and Health Care HS17 Quality of Life Measurement HS11 Epidemiology of Infectious Diseases CE05 Regression Analysis ESP09 Epidemiological Research: an Avantgarde Introduction ESP67 Regression analysis for clinicians EWP23 From problem to solution in public health HS18 Repeated Measurements CE08 Genetic Linkage Analysis: Model Free Analysis GE05 Scientific Writing in English for Publication SC07 Genetic-epidemiologic Research Methods GE02 Site Visit to the Municipal Health Service PU03 Rotterdam Genome Wide Association Analysis ESP29 SNPs and Human Diseases GE08 Genomics in Molecular Medicine ESP57 Social Epidemiology ESP61 Health Economics ESP25 Study Design CC01 Health Services: Research and Practice HS15 Survival Analysis ESP28 History of Epidemiologic Ideas ESP53 Survival analysis for clinicians EWP24 Integration module PU04 The Why and How of Readable Articles ESP60 International Comparison of Health Care Systems HS03a Topics in Health and Diseases in the Eld- ESP56 Intervention Development and Evaluation HS02c Topics in Meta-analysis ESP15 Intervention Research and Clinical Trials EWP04 Working with SPSS for Windows SC04 Introduction to Clinical Research EWP01 Women's Health EP19 Health Introduction to Clinical and Public Health Genomics EWP11 For up-to-date course descriptions please go to 39 Study Guide

42 CC01: Study Design Scheduled: 3-21 Sep 2012 Faculty: A. Dehghan, PhD, Prof. M. Sturkenboom, PhD, and Prof. H. Tiemeier, MD PhD, ECTS: 4.3 In this course, the principles and practice of follow-up and case-control studies will be taught. The theory underlying the different design options will be discussed in depth. The course focuses on the classical approach but also addresses modern concepts. The practice of conducting follow-up and case-control studies with emphasis on issues of validity will be discussed. Lectures will be complemented by exercises using current examples of epidemiological studies. Participants will be asked to work out a study design and prepare a formal presentation. Understanding of main concepts of design of follow-up and case-control studies. Ability to design a follow-up or case-control study given a research question. Ability to discuss research papers with respect to aspects of validity. CC02: Biostatistical Methods I: Basic Principles Scheduled: 24 Sep - 19 Oct 2012 Faculty: Prof. H. Boersma, Ir. PhD, and others ECTS: 5.7 The analysis of collected data is an inevitable part of almost any medical research project. Consequently, knowledge of and insight in the basic principles of data-analysis are essential for medical researchers. The course CC02 - Classical Methods for data-analysis is designed to teach classical and basic statistical techniques for the analysis of medical research data. The course comprises lectures as well as computer practicals, in which students will apply the widely used statistical software package SPSS to work through exercises. CC02 consists of two parts. In part A, which lasts one week, basic applications of biostatistics will be introduced, including descriptive statistics, general principles of statistical hypothesis testing, statistical inferences on means and proportions, and interval estimates for association measures. In part B, which last two weeks, more advanced methods will be discussed, including the analysis of determinants of continuous and dichotomous outcome measures, the linear regression and logistic regression models, time-to-event analysis, the Cox proportional hazard regression model, and stratified analysis. During the lectures, time will be spent on practical examples and exercises. SPSS will be introduced in the first week. Throughout the course, examples of SPSS-programs and -output will be demonstrated in relation to the several topics that will be discussed. Understanding and using basic applications of biostatistics in the analysis of medical research data. Erasmus MC and Netherlands Institute for Health Sciences 40

43 Health Sciences & Clinical Research for Medical Students CC02A: Biostatistical Methods I: Basic Principles Part A Scheduled: Spring 2013 Faculty: Prof. H. Boersma, Ir. PhD, and others ECTS: 2 The analysis of collected data is an inevitable part of almost any medical research project. Consequently, knowledge of and insight in the basic principles of data-analysis are essential for medical researchers. The course CC02 - Biostatistical Methods I: Basic Principles is designed to teach classical and basic statistical techniques for the analysis of medical research data. The course comprises lectures as well as computer practicals, in which students will apply the widely used statistical software package SPSS to work through excercises. In CC02 part A, which lasts one week, basic applications of biostatistics will be introduced, including descriptive statistics, general principles of statistical hypothesis testing, statistical inferences on means and proportions, and interval estimates for association measures. During the lectures, time will be spent on practical examples and exercises. SPSS will be introduced. Throughout the course, examples of SPSS-programs and -output will be demonstrated in relation to the several topics that will be discussed. Objective: Understanding and using basic applications of biostatistics in the analysis of medical research data, like descriptive statistics, general principles of statistical hypothesis testing, statistical inferences on means and proportions, and interval estimates for association measures. CE02: Clinical Epidemiology Scheduled: 22 Oct - 16 Nov 2012 Faculty: Prof. A. Hofman, MD PhD, Prof. M. Hunink, MD PhD, Prof. E. Steyerberg, PhD, Prof. B. Stricker, MB PhD, Prof. H. Tiemeier, MD PhD, A. Ikram, MD PhD ECTS: 5.7 In clinical epidemiology, research is focused on questions of diagnosis, prognosis and etiology. To address these questions, several research options are available, including intervention trials and case-control studies using data obtained in a clinical setting. In addition, combined with decision analysis, results from clinical epidemiologic research may be used in treatment decision. In the course, the principles and practice of clinical epidemiology will be considered and examples from the literature will be worked out and discussed. The aim is to provide the participants with the knowledge to evaluate and judge applied clinical research and data analysis and give a sufficient scientific and methodological background to actively participate in clinical studies. Topics are: principles of applied clinical research, diagnostic reasoning, diagnostic and prognostic research, comparative (clinical) experimental study, comparative non experimental study, meta-analysis and evidence based medicine. Ability to evaluate and judge applied clinical research and data analysis. Ability to actively participate in clinical studies. CE05: Epidemiology of Infectious Diseases Scheduled: 8-12 April 2013 Faculty: M. Schim van der Loeff, MD PhD, Staff of Public Health Service Amsterdam, National Institute for Public Health Bilthoven and invited speakers. Prerequisites: Introductory level epidemiology ECTS: 1.4 Quantitative approaches play an important role in the understanding of the spread of infectious diseases and provide important tools for prevention. During the course, the basic notions that describe the mechanisms behind the spread of a disease will be introduced. Several examples of what can be learned from the use of quantitative models will be given. The relation between the specific characteristics of some infectious diseases and their spread will be exemplified, e.g. for tuberculosis, hepatitis, rubella, AIDS. Only a basic level of mathematics is needed, and exercises will be given to practice the theoretical concepts. 41 Study Guide

44 Topics covered: 1) Important concepts and tools in modelling the spread of infectious disease. 2) Some important quantities related to the spread of infectious diseases (incidence, prevalence, cumulative incidence, incubation time); estimation of these quantities, with an example from the HIV epidemic. 3) Simulating large scale and small scale epidemics using the computer. 4) Basic reproductive number (R0) as central determinant of whether an epidemic develops. 5) Mode of transmission (e.g. airborne, sexual) in relation to the characteristics of spread. 6) Heterogeneous spread; the role of mixing between subgroups; contact patterns. 7) Molecular epidemiology as a new tool to monitor and model the spread of an infectious disease. Prevention programmes. 1) Vaccination strategies in relation to characteristics of the infectious disease. 2) Cost-effectiveness analyses of prevention and treatment. 3) Screening of pooled blood samples. Understanding the basic mechanisms of the spread of infectious diseases. Acquire knowledge of the important concepts and tools in modelling spread of infectious diseases. Understanding how infectious disease models can provide important tools for prevention. CE08: Repeated Measurements in Clinical Studies Scheduled: April 2013 Faculty: Prof. E. Lesaffre, PhD Prerequisites: Courses for the Quantitative Researcher (EP17) or equivalent knowledge. Familiarity with standard regression models such as the multiple linear regression and logistic regression model. No previous experience of repeated measurements analysis is required. ECTS: 1.4 The course covers statistical methods to be used where one or more variables are repeatedly measured in time on the same experimental unit. For instance, in a clinical trial, the outcome variable can be measured at baseline and at different times during the treatment period. In a meta-analysis, the study can be regarded as the experimental unit and the observations of patients within the same study as repeated measurements. In the last 10 or 15 years much progress has been made in the development of new methods of analysis. In recent years several of these new methods have been implemented in commercially available computer packages. First an overview of classical approaches to repeated measurements will be given, and, since all modern methods are likelihood based, a review of likelihood theory is given. Then modern methods are introduced. For approximately normally distributed response, focus will be on the General Linear Mixed Model. For non-normal response, the generalized estimating equations (GEE) approach for marginal models is discussed. Attention is also paid to random effects models, for instance random effects logistic regression. Examples of clinical and epidemiological applications will be given. In four computer practical s, the procedures Proc Mixed, Proc Genmod and Proc Nlmixed of the SAS statistical package are used to acquire hands on experience in applying these techniques to real data. Ability to use statistical methods where one or more variables are repeatedly measured in time on the same experimental unit. CE09: Bayesian Statistics Scheduled: May Faculty: Prof. E. Lesaffre, PhD Prerequisites: Classical Methods for data-analysis (CC02), Modern Statistical Methods (EP03) and Courses for the Quantitative Researcher (EP17) or equivalent knowledge Intermediate level epidemiology and statistics. Repeated Measurements (CE08) and Missing Values in Clinical Research (EP16 or EWP07) are strongly recommended. ECTS: 1.4 There is growing acknowledgement of the value of Bayesian methods for complex models in biostatistics and epidemiology, in dealing with issues such as multiplicity, measurement error, spatial associations and hierarchical structure. This course will introduce the essentials of Bayesian ideas, emphasizing practical application using exact and simulation-based software. Examples will include the use of Bayesian methods in clinical trials, institutional comparisons, smoothing of disease rates, and frailty models. Erasmus MC and Netherlands Institute for Health Sciences 42

45 Health Sciences & Clinical Research for Medical Students Introduce Bayesian concepts and contrast them with the frequentist approach Understand the background and the importance of computer intensive methods in Bayesian statistical analyses, such as the Markov Chain Monte Carlo (MCMC) techniques: Gibbs and Metropolis-Hastings sampling Be able to work with some Bayesian software, such as WinBUGS, 1stBayes, etc. Understand the applications and developments in the epidemiological literature involving Bayesian approaches Keywords: Bayesian analysis, Gibbs sampling, MCMC EP02: Methodologic Topics in Epidemiologic Research Scheduled: Nov 2012 Faculty: A. Dehghan, MD PhD Prerequisites: Study Design (CC01) ECTS: 1.4 This course discusses major concepts in epidemiologic research with an emphasis on their historic development. The course will address the development of epidemiologic thinking about causation and causal inference, confounding and effect-modification and misclassification. The course consists of seminars in which major papers will be discussed with the active participation of the participants. Gain insight in the historic development of major concepts in epidemiologic research. EP03: Biostatistical Methods II: Classical Regression Models Scheduled: 3-21 Dec 2012 Faculty: D. Rizopoulos. PhD, B. Hansen, PhD Prerequisites: Biostatistical Methods I: Basic Principles (CC02) ECTS: 4.3 The aim of this course is to introduce several important modern statistical methods that are useful in studies of the relation between a number of factors on the one hand, and the occurrence of an outcome event on the other. These methods are widely applied in clinical and epidemiological research. This course will emphasize the principles on which these methods are based and the interrelation between these methods as well as the more classical methods for data analysis. The course starts with an introduction to likelihood theory, using simple examples and a minimum of mathematics. Next the most important regression models used in medical research are introduced. The course includes various computer practicals in which the methods discussed can be applied using SPSS and SAS. Especially in the last week, time will also be spent on exercises during lecture times. Topics are: maximum likelihood methods; logistic regression; relative risk- and risk difference models; model goodness-of-fit and regression diagnostics; conditional logistic regression; exact (conditional) logistic regression; Poisson regression and analysis of 'event history' data, the latter including an extensive discussion of the Cox proportional hazards regression model. Ability to understand and use several important modern statistical methods in the analysis of medical research data. 43 Study Guide

46 EP12: Psychiatric Epidemiology Scheduled: May 2013 Faculty: Prof. H. Tiemeier, MD PhD, Prof. F. Verhulst, MD PhD, and invited speakers. Prerequisites: Some knowledge of basic epidemiological issues. ECTS: 1.1 This four-day course focuses on the principles and practice of psychiatric epidemiology. Basic concepts and issues that are specific to both child and adult psychiatric epidemiology are covered. Psychiatric issues that will be used to illustrate concepts and practice of psychiatric epidemiology include: prevalence studies, longitudinal studies, the role of risk and resilience, and genetic epidemiology. Invited speakers will cover particular topics such as migration and psychiatric disorder, the epidemiology of bipolar disorder, schizophrenia and addiction in more detail. Understanding the basic concepts of psychiatric epidemiology. Ability to evaluate and judge applied psychiatric research. EP13: Cancer Epidemiology Scheduled: Spring 2014 Faculty: Prof. F. van Leeuwen, Ir. PhD, and invited speakers Prerequisites: Intermediate level epidemiology ECTS: 1.4 Cancer is a major cause of morbidity and mortality in the developed world. The aim of this 5-day course is to provide an overview of the contributions of exogenous and endogenous factors to the risk of various cancers. The course starts with descriptive cancer epidemiology and an overview of current concepts of cancer development at the molecular and cell level. Subsequently, genetic and non-genetic risk factors for the most important cancers will be extensively discussed, as well as gene-environment interactions. Special attention will be given to risk factors for multiple primary cancers and recent results of chemo prevention studies. Although the emphasis of the course will be on etiologic factors, one session will specifically address time trends in cancer incidence, mortality and survival rates, followed by a discussion on whether or not we are winning the battle against cancer. Gain insight in the contributions of exogenous and endogenous, genetic and non-genetic factors to the risk of various cancers, and gene-environment interactions. Acquire knowledge on descriptive cancer epidemiology and current concepts of cancer development at the molecular and cell level. EP16: Missing values in Clinical Research Scheduled: May 2013 Faculty: Prof. H. Thijs, PhD and Prof. G. Molenberghs, PhD Prerequisites: Biostatistical Methods II (EP03), Courses for the Quantitative Researcher (SC17 or EP17) and Repeated Measurments in Clinical Studies (CE08 or EWP07) or equivalent knowledge ECTS: 0.7 Missing data frequently occur in clinical trials. An important cause for missing data is patients who leave the study prematurely, so-called dropouts. Alternatively, intermittent missing data might occur as well. It becomes hard to comply with the intention-to-treat (ITT) principle, when patients are evaluated only once under treatment. However, when enough repeated measurements are taken the information of the dropouts might still be used. One can use of the observed portion of the data to retrieve information on dropouts. In general commonly used methods to analyse incomplete longitudinal clinical trial data include complete-case (CC) analysis and an analysis using the last observation carried forward (LOCF). However, these methods are based on strong and unverifiable assumptions about the dropout mechanism. Over the last decades, a number of longitudinal data analysis methods have been suggested, providing a valid estimate for, e.g., the treatment effect under less restrictive assumptions. Erasmus MC and Netherlands Institute for Health Sciences 44

47 Health Sciences & Clinical Research for Medical Students The assumptions regarding the dropout mechanism have been classified by Rubin and co-workers as: missing completely at random (MCAR), missing at random (MAR) and missing not at random (MNAR). We will review various repeated measurements models and indicate under which missing data mechanism they will provide valid estimates of the treatment effect. Finally, since it is impossible to verify that the dropout mechanism is MAR we argue that, to evaluate the robustness of the conclusion, a sensitivity analysis thereby varying the assumption on the dropout mechanism should become a standard procedure when analyzing the results of a clinical trial. Objective: Gain insight in various repeated measurements models and under which missing data mechanism they will provide valid estimates of the treatment effect. EP18: Analysis of Growth Data Scheduled: Spring 2014 Faculty: Prof. P. Eilers, Ir. PhD, and Prof. S. van Buuren, PhD Prerequisites: Courses for the Quantitative Researcher (SC17 or EP17) or equivalent knowledge. Familiarity with basic statistical ideas. Experience with R is useful but not required. ECTS: 0.6 Data on (human) growth are becoming available in increasing numbers and variety. Examples are height, body mass index (BMI), embryo size, and stages of pubertal development. Many advances in statistical techniques for analyzing such data have been made. Many researchers and practitioners working with this type of data are interested in description, statistical analysis, and the creation of reference curves. The course will present modern methods for modelling the entire distribution (rather than just the mean) as a function of one or more covariates, typically age and sex. For continuous data, like weight and BMI, a flexible model is used to model distributions with changing location, spread, skewness and kurtosis. These aspects are assumed to change gradually with age, resulting in smooth curves that are estimated from the data. For discrete data, like stages of pubertal development, a multinomial model with smoothly changing class boundaries will be used. To explore data and diagnose model fit we use smooth quantile and expectile curves, Z-scores, worm plots, and Q statistics. The course concentrates on cross-sectional data, and will describe the theory behind the proposed statistical tools. Excessive technical detail is avoided. Many graphical illustrations will be used so the course will appeal to a wide audience of epidemiologist, statisticians and (public) health professionals. Free software, written in the R language, is available and its use will be explained. The computer labs allow course participants to get hands-on experience, guided by the course presenters. To understand and apply modern methods for presenting and analyzing growth data. EP19: Women's Health Scheduled: January Faculty: M. Kavousi, PhD, J. Roeters van Lennep, PhD, Prof. Oscar H. Franco, PhD ECTS: 0.9 Department of Epidemiology, in collaboration with the department of Internal Medicine, Erasmus University medical Center, offers medical and health professionals a fully articulated course in Women's Health. The course offers participants a complementary, interdisciplinary understanding of the health and disease in women and their implications for medical research, policy making, and health care. This course is designed for motivated gynecologists, internists, oncologists, neurologists, psychologists, epidemiologists, nutritionists, public health scientists, general practitioners, and nurses wishing to expand their knowledge and become leaders in women s health. Objective: 1. Develop an understanding of the multiple determinants of women's health 2. Promote knowledge on women's health in the primary and secondary health care settings thus improving health and wellness of women in the community. 45 Study Guide

48 ESP01: Principles of Research in Medicine and Epidemiology Scheduled: Aug 2012 Faculty: Prof. A. Hofman, MD PhD ECTS: 0.7 This course will provide an orientation to medical research from a quantitative and epidemiological viewpoint. The course will give an introduction to the design of clinical and public health research, and it will discuss measures of disease frequency and association, and the validity of research in medicine. It will give an overview of elements of data-analysis. Understanding the design and data-analysis of clinical and public health research. Gain insight in measures of disease frequency and association, and the validity of research in medicine. ESP03: Introduction to Data-analysis Scheduled: Aug 2012 Faculty: Adelin Albert Prerequisites: No prior experience with statistical programs or computers is required ECTS: 1.0 This course is a general introduction to the basics of statistics used in biomedical and public health applications. We start with a general definition of statistics and give some examples. We then review the notions of population, sample, variables (qualitative and quantitative) and data (missing, outlying, and censored). Next, the course will focus on modern ways to describe data such as tables, graphs, distributions and summary statistics (mean, standard deviation, median, quartiles), as required in the international scientific literature. The analysis of survival data will also be envisaged, in particular the renowned Kaplan-Meier survival curve. Finally, the association between variables will be discussed (correlation, relative risk, odds ratio and regression) as well as the agreement between observers (Cohen kappa coefficient). The course will then turn on the relation between the population and the random sample and on how effects observed in the sample can be generalized to the total population. Some elementary probability elements will be needed here. This will lead to the important concepts of standard error and confidence intervals (for means, proportions, odds ratios). The general theory of hypothesis testing will be briefly outlined from an intuitive perspective and the fundamental concepts of statistical significance, power calculation and p-value will be introduced. Then, we shall review the most frequently used testing procedures: correlation test, unpaired and paired t-tests for comparing two means values, analysis of variance for comparing several means (with multiple tests correction), chisquared test (and Fisher exact test) for comparing two proportions and more generally for contingency tables, McNemar test for paired proportions, and two-way analysis of variance for repeated data. The logistic model and Cox model will be briefly alluded to because of their importance in the international medical literature. The basic principles underlying non parametric tests will be outlined and the most used distribution-free tests mentioned (Spearman correlation, Wilcoxon signed rank test, Mann-Whitney U-test, Kruskal-Wallis and Friedman tests). All topics covered in the course will be illustrated using real data from the medical and biomedical literature and applied during practical sessions. Objectives to have a clear understanding of what statistics is all about in medicine and public health, and to be acquainted with the most commonly statistical methods in the biomedical literature; to be able to assess when and how to apply these methods in real-life situations; to improve skills in data presentation, interpretation and communication; to perceive the importance of data analysis with respect to experimental planning, data collection, data reporting and data interpretation. Erasmus MC and Netherlands Institute for Health Sciences 46

49 Health Sciences & Clinical Research for Medical Students ESP04: Clinical Decision Analysis Scheduled: Aug 2012 Faculty: Z. Vokó, PhD Prerequisites: Principles in Research in Medicine and Epidemiology (ESP01) ECTS: 0.7 The learning objective of this course is to familiarise participants with the basic concepts of utilizing quantitative evidence in medical problem solving, using decision trees and expected utilities to structure clinical problems of individual patients. A framework for optimal decision-making in the clinical setting based on probability theory and the rational use of available information will be given. The theoretical principles introduced will be applied to decision problems involving individual patients. The main focus is on the efficient use of diagnostic information and diagnostic tests. In addition, the valuation of outcomes, including quality adjustment, will be introduced. The course is primarily intended for practicing physicians but anyone with an interest in evidence based medicine or health policy may benefit. No prior knowledge of the topic concerned is expected but participants are expected to be familiar with the basic concepts of epidemiology. to familiarise the participants with the basic concepts of clinical decision making and how these concepts can be used in actual clinical practice to introduce clinical reasoning based on the threshold approach and Bayesian diagnosis to familiarise participants with decision trees and expected utilities to structure clinical problems of individual patients ESP09: Regression Analysis Scheduled: Aug 2012 Faculty: Prof. Brian Marx, PhD Prerequisites: Introduction to Data-analysis (ESP03), Biostatistics for Clinicians (EWP22) or equivalent knowledge ECTS: 1.9 This intermediate level course aims at providing theoretical and practical training for epidemiologists, clinicians and other professionals of related health disciplines in statistical modelling with particular emphasis on linear, multiple and logistic regression. Included topics are: review of straight line regression and correlation, ANOVA for straight line regression, appropriateness of straight line model, polynomial regression, multiple regression analysis, partial F-test, dummy variables, statistical interaction, comparing straight line regressions, analysis of covariance, estimation and interpretation, goodness-of-fit, model selection, collinearity and outlier diagnostics. Students will learn the fundamental methods of statistical regression modeling for continuous response variables. Students will learn how to build and interpret a variety of multiple regression models, including models with continuous, nominal/ indicator, and polynomial explanatory regressor variables. Students will become familiar with outlier and collinearity diagnotics to refine models, as well as statistical software packages for computing multiple regression models. ESP10: Methods of Clinical Research Scheduled: Aug 2012 Faculty: Prof. H. Tiemeier, MD PhD Prerequisites: Principles of Research in Medicine and Epidemiology (ESP01), or equivalent knowledge. ECTS: 0.7 This course will give an introduction to clinical epidemiology. Due to its focus on the appropriate research design, measurement and evaluation, clinical epidemiology provides the scientific basis for the practice of medicine. The topics that will be covered in this course include risk (determinants of disease, pathogenesis), diagnosis (evaluation of diagnostic tests), prognosis (prediction of disease outcome), and management of disease (evaluation of therapy efficacy and safety). The course takes both a theoretical and a problem-oriented approach. 47 Study Guide

50 to gain understanding of the designs and analyses of clinical studies; to be able to plan, formulate, and implement clinical research; to be able to evaluate aetiological, diagnostic and prognostic research; to know the challenges and fallacies in modern clinical research. ESP11: Methods of Public Health Research Scheduled: Aug 2012 Faculty: Prof. A. Burdorf, Ir. PhD Prerequisites: Principles of Research in Medicine and Epidemiology (ESP01), or equivalent knowledge. ECTS: 0.7 This course aims to provide an introduction to the study designs and analytic methods available to public health researchers to describe the influence of important determinants on public health and to evaluate the effects of primary preventive intervention on public health. Examples are: standardisation of morbidity and mortality rates; life table analysis; calculation of measures of association and potential impact of relevance to public health; establishing effects of population interventions without randomization. In addition, a number of substantive issues will be discussed, such as inequalities of health; public health aspects of ageing; causes of cancer, and exposure assessment in environmental epidemiology. The course will be relevant to those who have a basic knowledge of epidemiology, and who wish to start a career in public health research. developing an understanding of a number of research design and analytic methods which are often used in Public Health Research; discussing a number of substantive issues in Public Health on the basis of recent research findings. ESP14: Clinical Trials Scheduled: Aug 2012 Faculty: Prof. J. Tijssen, PhD Prerequisites: Principles of Research in Medicine and Epidemiology (ESP01) and Methods of Clinical Research (ESP10), or equivalent knowledge. ECTS: 0.7 This course presents the principles and methods for designing and analyzing randomized clinical trials. The purpose of this course is to provide practical guidelines for the conduct of a clinical trial. Topics such as randomization, patient recruitment and ethics will be discussed. The methods of analyzing trials of various designs are presented. This course is intended for those who already followed introductory courses in study design, data-analysis and principles of research in medicine. ESP15: Topics in Meta-analysis Scheduled: Aug 2012 Faculty: Prof. M. Egger, PhD Prerequisites: Introductory level background in epidemiology and biostatistics. ECTS: 0.7 Programme Introductory lecture: Why do we need systematic reviews and meta-analyses? Lecture / pen and paper practical: Measures of association Lecture: Basic statistical methods Computer practical Basic meta-analysis in Stata Lecture / demonstration: Identifying relevant studies Practical: Identifying relevant studies in PubMed Lecture Assessing quality and risk of bias Lecture The scope of meta-analysis: Meta-analysis of observational studies Case study / group work: How good is this meta-analysis? Erasmus MC and Netherlands Institute for Health Sciences 48

51 Case study / group presentations How good is this meta-analysis? Lecture Explaining heterogeneity and detecting bias Lecture / case study Individual participant data (IPD) meta-analysis Lecture Meta-analysis of dose-response relationships in epidemiology Computer practical Advanced meta-analysis in Stata I & II Students need a calculator with LOG function. Health Sciences & Clinical Research for Medical Students ESP21: Pharmaco-epidemiology Scheduled: Aug 2012 Faculty: Prof. B. Stricker, PhD Prerequisites: Principles of Research in Medicine and Epidemiology (ESP01) and Methods of Clinical Research (ESP10) or equivalent knowledge. ECTS: 0.7 Pharmaco-epidemiology pertains to the study of the use and of the effects of drugs. It links clinical pharmacology and epidemiology. This course provides, at an intermediate level, the theoretical basis for studying the intended effects as well as the adverse effects of drugs used in humans. The course will mainly focus on drug research after marketing, including post marketing surveillance and drug risk assessment. This course is intended for those who already followed introductory courses in study design, data-analysis and principles of research in medicine. Course objectives to know more about study designs in pharmaco-epidemiology to know how to address exposure as a determinant to know more about drug-specific bias and confounding ESP25: Health Economics Scheduled: Aug 2012 Faculty: K. Redekop, PhD Prerequisites: Introduction to Health Services Research (ESP42) ECTS: 0.7 Economic thinking is becoming increasingly important in health care. This course begins with a two-day introduction of main concepts of health economics. The remaining three days are used to provide students with more in depth knowledge. The student will learn to analyze the cost-effectiveness of health care interventions (e.g., medicine, diagnostic test, health care programme). Both methodology and practical examples will be covered. Exercises are used to illustrate the various steps in economic thinking. By the end of this course participants: will understand basic principles of health economics and their application at various levels (including countrylevel and hospital-level policymaking and single technology assessments) will be able to describe the aims and steps of a cost-effectiveness analysis, as well as the role of related activities such as computer modelling, cost analysis, and quality of life assessment. will be able to perform some basic level cost-effectiveness analyses through computer exercises. ESP28: Survival Analysis Scheduled: Aug 2012 Faculty: Prof. P. Haegerty, PhD Prerequisites: Principles of Research in Medicine and Epidemiology (ESP01), and Introduction to Data- analysis (ESP03) or Biostatistics for Clinicians (EWP22). Familiarity with general regression modeling and associated computer procedures is desirable but not essential. ECTS: 1.9 This course will provide an introduction to the concepts and methods of survival analysis. We begin with an overview of the general goals of survival analysis, the types of censored data that are typically recorded, basic notation and terminology, and some motivating biomedical examples. 49 Study Guide

52 The Kaplan Meier (KM) approach for estimating survival curves will be described and the log-rank test used for comparing estimated survival curves. We then introduce the Cox Proportional Hazards (PH) model and describe its characteristics, including reasons for its popularity and the meaning of the PH assumption. Presentation will focus on model specification and the interpretation of estimated regression coefficients. Methods for assessing the PH assumption will be discussed, and options for analysis when the PH assumption is not satisfied will be described. One option is referred to as the 'stratified Cox procedure', which will be described and illustrated using analysis of clinical trial data. Another option involves using time dependent covariates, which will also be described and illustrated. A general description will also be given on the use and characteristics of the 'extended Cox model', which permits time dependent variables of any type. We will provide examples of the use of the extended Cox model to analyze survival data involving time dependent variables. Methods appropriate for settings in which there are competing risks will be outlined. STATA will be used as the primary statistical package to illustrate survival analysis using specific biomedical examples. Some use of R or SAS may also be provided. (30 hrs) estimate survival curves using the Kaplan-Meier method; estimate the (grouped or smoothed) instantaneous mortality or hazard rate; compare two or more survival curves using a log-rank or related test; fit appropriate Cox regression models to continuous time data from epidemiologic cohort studies using STATA, and evaluate the fit of these models: regression models discussed will include those with multiple predictor variables, and extensions of the basic Cox model that permit time-varying covariate effects (non proportional hazards), and stratified Cox models; interpret regression coefficients from Cox regression models, and test hypotheses about these coefficients; use time-dependent covariates in the Cox model and interpret the coefficients; (time permitting) fit appropriate Poisson regression models to grouped data from epidemiologic studies, and evaluate the fit of these models. ESP29: Genome Wide Association Analysis Scheduled: Aug 2012 Faculty: Prof. C. van Duijn, PhD, B. Müller Myhsok, PhD, Y. Aulchenko, PhD and D. Czamara, PhD Prerequisites: Basic understanding of genetic epidemiology ECTS: 1.4 Genome wide association analysis is a new approach to study the genetics of multifactorial disorders, that has yielded spectacular successes in discovery of genes involved in complex disorders such as type 2 diabetes, cardiovascular disease and age related macular degeneration. Recent developments in genotyping technology have facilitated researchers to incorporate these analyses into large genetic, clinical and epidemiological studies. This course aims to introduce epidemiologists, molecular biologists and clinicians into the basic principles of genome wide association analysis. The course addresses the state of the art of techniques for data handling, quality control, data analysis of single and multiple markers, gene interactions and adjustments for confounding by other determinants of disease and population (sub)structure. Further, issues related to the design of genome wide association analysis are discussed including statistical power and population selection. Lectures are accompanied by instructive hands-on computer exercises on the analysis of case-control series and quantitative traits using software packages that are available in the public domain such as PLINK, GenABEL and WG_Permer. After completing the course, participants will be able to perform a basic genome association analysis on their desktop PC s. Erasmus MC and Netherlands Institute for Health Sciences 50

53 Health Sciences & Clinical Research for Medical Students ESP38: Conceptual Foundation of Epidemiologic Study Design Scheduled: Aug 2012 Faculty: Prof. K. Rothman ECTS: 0.7 This course elaborates the fundamental principles of epidemiologic study design. It begins with an introduction to the basic principles of epidemiologic inference, including concepts of causation, causal inference and the measurement of disease occurrence and causal effects. With this foundation, attention shifts to the principles of study design and discussion of the major types of epidemiologic study, primarily cohort and case-control studies. The utility and consequences of matching in subject selection is also addressed. The course concludes with a presentation of the underlying principles of epidemiologic data analysis. being conversant with the concepts of causation and causal inference in epidemiology, as well as the basic epidemiologic measures, especially risk and rate measures, and effect measures based on them; understanding of and ability to explain the conceptual similarities and differences between cohort and casecontrol studies; ability to define and describe confounding and discuss the primary ways in which it can be controlled, and articulate why matching of subjects may be inadequate as a means to prevent confounding. ESP39: Cohort Studies Scheduled: Aug 2012 Faculty: Jonathan Samet Prerequisites: Introductory level epidemiology course work and introductory level biostatistics. ECTS: 0.7 This course will provide an introduction to the cohort design for students with an intermediate level background in epidemiology. It will focus on design and interpretation, emphasizing the principles and complexities of data collection over time and the biases that may affect cohort data. Topics to be covered include cohort definition, follow-up and definition of outcomes, fixed and time-dependent exposures, quality control, mixed study designs (nested case-cohort studies), and quality assurance and control. The course will also cover the basic analytic methods appropriate to various types of cohort data, including the application of both non-parametric methods and regression models. The course will be based on lectures as well as in small group and plenary discussions of exercises. Competencies to be gained in the course include the ability to interpret findings from cohort studies and to apply principles for the design of cohort studies. To be able to recognize the general design of a cohort study To identify salient issues in the conduct and implementation of cohort studies To recognize the main techniques for the analysis and issues in the interpretation of cohort data ESP40: Case-control Studies Scheduled: Aug 2012 Faculty: Prof. M. Szklo Prerequisites: Introductory level epidemiology course work and introductory level biostatistics. ECTS: 0.7 The course will provide an introduction to design and analysis of case-control studies. Topics to be covered include nested case-control and case-cohort designs, selection of cases and controls, the parameter measured by the odds ratio as a function of control selection, matched and unmatched strategies, common biases, and evaluation of additive and multiplicative interaction in case-control studies. These topics will be discussed in the context of the case-control design as a special way to analyze cohort data. In addition, a discussion of adjustment approaches appropriate to case-control data will be covered, including stratified and regression methods. The course will be based on classroom lectures and small group discussions of simulation exercises. to understand the main case-control study designs and understand the importance of the type of control group to the parameter estimated by the exposure odds ratio; to recognize the main threats when drawing inferences from results of case-control studies; to learn and apply the main techniques of confounding adjustment and assessment of interactions in casecontrol studies. 51 Study Guide

54 ESP41: Introduction to Global Public Health Scheduled: Aug 2012 Faculty: Prof. R. Bonita, PhD and Prof. R. Beaglehole, MD PhD ECTS: 0.7 The overall strengths and weaknesses of epidemiology and public health will be discussed and the important health effects of globalisation analysed. The main outcome of the course will be a better understanding of how epidemiology and public health can more effectively protect the health of disadvantaged populations in the new and changing global context. The specific health issues to be discussed include: the tobacco pandemic, the rise of the obesity epidemic, cardiovascular disease surveillance, prevention and control, global environmental change, and new threats to health using case examples such as SARS and Avian Bird Flu; other examples of topical interest will be discussed as appropriate. For each health problem there will be a discussion of: frequency of occurrence, major determinants, intervention policies and programmes, and evaluation of the effectiveness of the interventions. a greater awareness of the full range of global public health challenges; increased understanding of the strengths and weaknesses of epidemiology and public health in responding to these challenges; a greater understanding of how to increase the positive effects of globalisation on health and reduce the negative effects. ESP42: Methods of Health Services Research Scheduled: Aug 2012 Faculty: Prof. N. Klazinga, MD PhD ECTS: 0.7 Health Services Research addresses issues such as health manpower planning, access and quality of health care delivery, financing and use of health care services, implementation of change and the overall functioning of health care systems. This introductory course provides insight in the various research questions, research designs, data-collection methods and analyses methods used in health services research. It puts emphasis on the links between research, policy and practice. The course is organised around lectures and group exercises. Providing insight in the various research questions, research designs, data collection methods and analyses methods used in health services research. ESP43: Principles of Genetic Epidemiology Scheduled: Aug 2012 Faculty: Prof. C. van Duijn, MD PhD ECTS: 0.7 This course aims to give a basic introduction to various methods used in classical genetic epidemiology. In combination with the course Searching Genes for Complex Disorders, the course offers an excellent introduction to genetic epidemiologic research for epidemiologists, clinicians and molecular biologists with no background in genetic epidemiology. Participants are introduced to the basic principles of population genetics, segregation, linkage and association analyses. The relevant background of human genetics and statistics is presented. The goal of the course is that participants are able to interpret the findings in modern genetic research. to give a basic introduction to various methods used in classical genetic epidemiology; ability to interpret the findings in modern genetic research. Erasmus MC and Netherlands Institute for Health Sciences 52

55 Health Sciences & Clinical Research for Medical Students ESP45: Primary and Secondary Prevention Research Scheduled: Aug 2012 Faculty: Prof. H. de Koning, MD PhD and Prof. Oscar Franco, PhD ECTS: 0.7 This course will introduce and illustrate methods and practices of research in the planning, development and evaluation of interventions to prevent ill health. Primary and secondary prevention may work together, depending on the determinants of disease and technology available. Life style factors, like for example cigarette smoking, dietary habits and physical activity, are important determinants of health and disease. Therefore, promoting healthy life styles is important in public health interventions. Screening for diseases that are related to these determinants can possibly improve prognosis, gain life-years and quality of life. However, early detection also means a longer period of life during which a person is aware of having the disease, and false-positive test results will induce unnecessary diagnostic interventions. Crucial in prevention research is the population perspective, with consequences for designing a study, evaluating an intervention, communicating to the people and setting priorities. Special emphasis will be given to cancer research, cardiovascular interventions, but also to preventing language delays in children or promoting alcohol consumption. The course will consist of lectures, exercises and presentations of illustrative examples of primary and secondary prevention research. introducing the methods and practices of primary and secondary preventive research; introducing the biases and interpretation of screening to detect diseases early in order to improve survival of quality of life; illustrating when to implement screening strategies, and how to implement and evaluate primary prevention strategies; giving up-to-date information on the determinants of and policies for cancer and cardiovascular prevention. ESP48: Causal Inference Scheduled: Aug 2012 Faculty: Prof. M. Hernán, MD PhD Prerequisites: Intermediate-level courses in epidemiology and biostatistics. Previous experience in epidemiologic research recommended ECTS: 0.7 The goal of many epidemiologic studies is to quantify the causal effect of an exposure on an outcome. In contrast, commonly used statistical methods provide measures of association that may lack a causal interpretation even when the investigator 'adjusts for' all potential confounders in the analysis of a properly designed study. To eliminate the discordance between the causal goals and the associational methods in epidemiology, it is necessary to a) formally define causal concepts such as causal effect and confounding, b) identify the conditions required to estimate causal effects, and c) use analytical methods that, under those conditions, provide estimates that can be endowed with a causal interpretation. These (causal) methods can be used under less restrictive conditions than traditional statistical methods. For example, causal methods allow one to estimate the causal effect of a time-varying exposure in the presence of time-dependent confounders that lie on the causal pathway between exposure and outcome. This course combines counterfactual theory and graph theory to present an integrated framework for causal inference from observational data, with a special emphasis on complex longitudinal data. The course presents the latest methodologic developments for the design and analysis of longitudinal studies. recognize and formulate well defined questions concerning causal effects; use causal diagrams to represent a priori subject-matter knowledge and assumptions; identify the settings in which conventional methods for data analysis are inadequate. 53 Study Guide

56 ESP53: History of Epidemiologic Ideas Scheduled: Aug 2012 Faculty: Prof. A. Morabia, Md PhD Prerequisites: No absolute pre-requisite but familiarity with the material taught in introductory and intermediate-level epidemiology courses is useful as the lectures move rapidly from basic to more advanced material ECTS: 0.7 This is a methodology course, which focuses on the historical evolution of methods (e.g., study designs) and concepts (e.g., confounding, bias, interaction and causal inference) that constitute today's epidemiology. For each topic, we review and discuss the historical contexts and some landmark studies that led to specific innovations in terms of performance of group comparisons, population thinking and framing of hypotheses. We finally discuss the historical conditions for the emergence of epidemiology as a scientific discipline, the phases it went through and its potential, future developments. describe the historical context of the emergence and the evolution of epidemiologic methods and concepts; identify historical phases in the construction of theory for epidemiologic research; identify landmark studies that led to specific innovations in terms of group comparisons, population thinking and framing of hypotheses; integrate a historical perspective in your own teaching of epidemiology. ESP57: Genomics in Molecular Medicine Scheduled: Aug 2012 Faculty: Prof. A. Uitterlinden, PhD. J. van Meurs, PhD, F. Rivadeneira, MD PhD Prerequisites: Familiarity with general genetic concepts. ECTS: 1.4 Molecular genetics plays an increasingly important role in medical research. The course addresses various molecular principles relevant for genetic epidemiological research. Different approaches will be discussed to come to the localisation of disease genes. Cloning of disease genes will be discussed from the bench point of view and with the use of modern bio-informatical methods. The course is particularly relevant for clinicians and epidemiologists who wish to be introduced in methods for identifying (complex) disease genes and its practical applications and basic knowledge of molecular biology. To understand the background of the application of molecular techniques in medicine and epidemiology To understand how disease genes are identified To be updated about advances in molecular genetics and population genomics ESP59: Demography of Ageing Scheduled: Aug 2012 Faculty: V. Canudas-Romo, PhD ECTS: 0.7 The average number of births per women (TFR) in the Netherlands in the year 2008 was 1.77, but is this the actual average number of children that women aged 15 in 2008 will have? In a developing country with high fertility (above 3 children per woman), why would population keep growing in a scenario where fertility suddenly drops to replacement level of about 2.1 children per women? How many years of life expectancy could be gained if HIV/AIDS was eliminated? How would the age pattern of mortality change if maternal mortality was reduced to reach the MDG-5 goal? How long do we live? Overview Ways to answer these questions are addressed in this course. Emphasizes is put on the theoretical concepts underlying the methodology of population models, as well as the practice of estimating and interpreting demographically meaningful results. During the course students use population data and calculate basic demographic measures. Course materials are presented interactively, allowing students to gain hands-on experience in working with measures of fertility, mortality, population growth and become familiar with the type of research that can be based on them. Erasmus MC and Netherlands Institute for Health Sciences 54

57 Health Sciences & Clinical Research for Medical Students Objectives At the end of this course a successful student will: 1. Calculate and interpret mortality, fertility, and population growth measures and concepts 2. Refresh basic mathematics from college and learn how they are used in demographic analysis. 3. Calculate and interpret measures and concepts used in life table constructions. 4. Lear some about some of the pressing current topics in demography. ESP60: The Why and How of Readable Articles Scheduled: 18 and 25 August 2012 Faculty: D. Alexander ECTS: 0.6 As a scientific writer, your first duty is to yourself. By writing clearly and transparently, you will not only appeal to editors, but also increase the chances that your work will be read - and cited - by others. So how come, as Francis Crick wrote in 1994, that "there is no form of prose more difficult to understand and more tedious to read than the average scientific paper"? What is it precisely that goes wrong? Do the rules of so-called "scientific English" make confusion and tedium inevitable? The answer: no, not if they're properly understood! This workshop examines the requirements of science and the needs of readers. On the way, one or two myths about scientific writing are explored, exposed and exploded. The value of the course will be greatly enhanced if participants can work with their own writing. To the first session you are therefore requested to bring FOUR copies of an Introduction you are currently writing or have recently written. Ideally, this should be printed with a line-spacing of 1.5, and should be no more than two pages in length. This workshop examines the requirements of science and the needs of readers. On the way, one or two myths about scientific writing are explored, exposed and exploded. ESP61: Social Epidemiology Scheduled: Aug 2012 Faculty: Prof. J. Mackenbach, MD PhD ECTS: 0.7 This course aims to introduce and illustrate modern research methods in social epidemiology, i.e. the study of the social determinants and social outcomes of health. The three main areas to be covered are: the measurement of health inequalities, the explanation of health inequalities, and the evaluation of interventions and policies to reduce health inequalities. Application of the research methods will be illustrated with historical landmark studies as well as recent examples from the international literature. The programme consists of lectures, hands-on exercises, and group discussions. The focus will be on socioeconomic inequalities in health, but the role of other social factors (such as ethnicity and marital status) will also be discussed. developing an understanding of a research methods used in Social Epidemiology; discussing a number of substantive issues in Social epidemiology on the basis of recent research findings. ESP62: Markers and Prognostic Research Scheduled: Aug 2012 Faculty: Prof. E. Steyerberg, PhD, and Prof. Harry Hemingway, PhD ECTS: 0.7 Prognostic research is of growing importance, as globally more people are living with disease and clinicians and policy makers seek ways of targeting existing treatments and improving health outcomes. There is a rapid expansion in the number of new prognostic markers. Often, bold claims are made about their potential to assist in personalising approaches to medical care and treatment. Prognostic models may be useful to summarize the effects of multiple predictors but while commonly developed, such models are often not well validated or used in clinical practice. 55 Study Guide

58 This course aims to provide the basic knowledge and principles to evaluate the quality of prognostic research and its translation to inform decision making of clinicians and policymakers. Drawing on recent examples and current controversies in cardiovascular disease, cancer, trauma and other conditions, the course examines molecular biomarkers and genetic variants through to the quality of healthcare as predictors of outcome. Topics include design, conduct and analysis of prognostic research; outcomes research; prognostic factors and prognostic markers; prognostic models for risk prediction; and stratified and personalised medicine. There will be lectures, interactive debates and critical appraisal of papers, but no computer labs (the course does not cover advanced statistical methods, see Further reading). The course is suitable for undergraduates medical students, practicing clinicians, and those contemplating or doing a Masters or PhD in a related area. ESP63: Masterclass: Advances in Genomics Research Scheduled: Aug 2012 Faculty: Prof. C. Janssens ECTS: 0.4 In these masterclasses, timely topics in genomics research will be addressed. Four renowned researchers will address the latest developments in epigenetics, forensic genomics, personalized medicine, whole genome sequencing, and new genetic variants. ESP64: Masterclass: Advances in Epidemiologic Analysis Scheduled: Aug 2012 Faculty: Prof. O. Miettinen, MD PhD, Prof. M. Hernan, MD PhD, Prof. M. Egger, PhD, Prof. T. VanderWeele, PhD and Prof. S. Greenland, PhD ECTS: 0.4 In this masterclass course timely topics in study design of epidemiologic and clinical studies will be addressed. Four renowned faculty members will address advanced study design issues in a seminar format. The lectures are open without registration for participants of the Erasmus Summer Programme, the Nihes programmes and employees of the Erasmus MC University Medical Center. For participants of the Erasmus Summer Programme who want to receive credits for this course, registration is necessary. ESP67: Masterclass: Epidemiological Research An Avantgarde Introduction Scheduled: Aug 2012 Faculty: Olli Miettinen ECTS: 0.7 This interactive Master Class will be based on the recent book by Miettinen and Karp Epidemiological Research: An Introduction (Springer 2012). It will have the following five 3-hours sessions: 1. Etiology as a pragmatic concern and object of study 2. Etiologic studies essentials and typology 3. Etiologic studies objects design 4. Etiologic studies methods design 5. Etiologic studies intervention counterparts EWP01: Introduction to Clinical Research Scheduled: 25 February 1 March 2013 Faculty: Prof. V. Jaddoe, MD PhD ECTS: 0.9 This course will address clinical research from a quantitative viewpoint. It will discuss risk, diagnosis, prognosis and treatment and the main options in studying clinical questions. The emphasis will be on validity of study design and interpretation of results. In particular, the observational study design and randomized clinical trial for efficacy research will be addressed. The course will have hands-on exercises on designing a study, interpretation of bias and taking account for confounding. gain insight in clinical research from a quantitative viewpoint, with emphasis on validity of study design; ability to apply major data-analytic and statistical techniques, such as the Kaplan-Meier actuarial method, the log-rank approach, logistic regression, and proportional hazards regression. Erasmus MC and Netherlands Institute for Health Sciences 56

59 Health Sciences & Clinical Research for Medical Students EWP02: Advanced Topics in Decision Making in Medicine Scheduled: March 2013 Faculty: Prof. M. Hunink, MD PhD Prerequisites: Clinical Decision Analysis (prof. J.Lubsen); Erasmus Summer Programme and Diagnostic Research (prof. M. Hunink); Erasmus Winter Programme or equivalent introductory courses ECTS: 1.9 This course deals with advanced topics in clinical decision making. We will discuss a proactive systematic approach to decision making in health care and review the principles of cost-effectiveness analysis. Special topics that will be addressed include problems with utility assessment and multi-attribute utility theory, cost-analysis, modelling issues, Markov process models, Monte Carlo simulation modelling, and Value of Information analysis. The course will consist of lectures in the morning and a computer practicum in the afternoon. During the week you will be given the opportunity to work on an own case example. Think of a decision problem that you are currently involved in or were recently confronted with. It may be a clinical decision problem involving a patient you care for, a management decision problem you are struggling with, a public health policy problem you are involved with, or a personal (preferably medical) decision problem. It must, however, be something you are willing to talk about in class and are motivated to work on. presentation or paper of case example, illustrating that the student has understood and can apply the concepts taught in the course. EWP03: Pharmaco-epidemiology and Drug Safety Scheduled: 25 February 1 March 2013 Faculty: Prof. B. Stricker, MB PhD, Prof. M. Sturkenboom PhD and K. Verhamme, MD PhD ECTS: 1.9 Pharmaco-epidemiology plays a role of increasing importance in the field of drug safety and regulatory decision making. On the one hand, the introduction of computers into clinical practice facilitates the performance of large-scale cohort studies and nested case-control studies. On the other hand, it creates some problems regarding the quality of outcome and exposure assessment. Because the commercial consequences of pharmaco-epidemiological studies may be enormous, discussions in this area may be heated. In this course, referring to established drug safety problems will highlight some of the complex aspects of outcome and exposure assessment in pharmaco-epidemiology. Understanding the complex aspects of outcome and exposure assessment in pharmaco-epidemiology. EWP04: Intervention Research and Clinical Trials Scheduled: 25 February 1 March 2013 Faculty: Prof. J. Lubsen, PhD ECTS: 0.9 Evidence-based Medicine (EBM) is based to a large extent on the results of randomised clinical trials. During this course, which is primarily intended for clinicians and other health care professionals with an interest in EBM, participants will learn how to critically appraise reports on clinical trials in published major journals. Using published data, professor Lubsen will illustrate the various trial designs that may occur, and how the effects of intervention can best be quantified. As will be shown by hands-on exercises using a spreadsheet program, essential parameters that are missing in publications (such as absolute event-rates) can often be estimated from the data that are given in a publication. Advanced topics to be covered are the relevance of cause-of-death competition for effect estimation and meta-analysis, the pros and cons of combined end-points and the design and analysis of cross-over trials. Alternatives to randomisation may be covered briefly. ability to appraise published reports on clinical trials critically. EWP05: Diagnostic Research Scheduled: 4-8 March 2013 Faculty: Prof. M. Hunink, MD PhD ECTS: Study Guide

60 In this course we will discuss the principles of interpreting diagnostic test results and evaluating diagnostic tests. We will first review basic concepts such as sensitivity, specificity, predictive probabilities, likelihood ratios, Bayes theorem and ROC curves. Then we will discuss possible forms of bias that can influence studies evaluating diagnostic test performance and a method to correct for verification bias. Diagnostic meta-analysis and summary ROC curves will be discussed. Next we will focus on modelling issues in using decision analysis to model diagnostic decisions. Conditional independence and multivariable prediction rules will be explained. The week will end with determining the optimal operating point on the ROC curve and estimating target values for new diagnostic technology. Understanding the principles of interpreting diagnostic test results and evaluating diagnostic tests. EWP10: Advanced Topics in Clinical Trials Scheduled: 4-8 March 2013 Faculty: Prof. M. Campbell, PhD, T. Clayton, PhD and Prof. J. Lubsen, PhD ECTS: 1.9 Programme: Implementing the CONSORT statement: not as simple as it looks Monitoring trial data and interim analysis Multiplicity issues and alternative trial designs Design and analysis of cluster randomised trials Analysis populations, composite endpoints and estimation of other parameters of treatment effect from published reports To explain the idea of cluster randomised trials Understand the principles of sample size calculations for cluster trials To show how to do simple analyses of cluster randomised trials EWP11: Introduction to Clinical and Public Health Genomics Scheduled: March 2013 Faculty: Prof. Cecile Janssens, PhD (to be confirmed) ECTS: 1.9 Common diseases such as type 2 diabetes and coronary heart disease result from a complex interplay of genetic and environmental factors. Recent developments in genomics research have boosted progress in the discovery of susceptibility genes and fuelled expectations about opportunities of genetic profiling for personalizing medicine. One of the challenges of the next decades is to translate these findings into clinical practice. The aim of this course is to introduce participants into the basic principles of translational research in genomics. The course will address the application of genetics tools in risk prediction, diagnostic and prognostic research. A basic introduction into the genetics of complex disorders will be given as well as a basic introduction in the principles of statistical genetics. to learn about potential applications of genomics in medicine and public health; to learn basic methods of translational research. EWP13: Advanced Analysis of Prognosis Studies Scheduled: March 2013 Faculty: Prof. E. Steyerberg. PhD Prerequisites: Knowledge of basic epidemiological notions, especially cohort studies and randomized controlled trials. Knowledge of statistical concepts (t-test, normal distribution, correlation) and regression techniques (linear, logistic, Cox regression). ECTS: 0.9 Prognostic models are increasingly published in the medical literature each year. But are the results relevant for clinical practice? What are the critical elements of a well developed prognostic model? How can we assume that the model makes accurate predictions for our patients, and not only for the sample that was used to develop the model (generalizability, or external validity)? In the course we will address these and other questions from a methodological perspective, using examples from the clinical literature. The participants will be encouraged to participate in interactive discussion to increase their knowledge of the roles that prognostic models may play in clinical practice and the critical factors that determine the validity of predictions from a prognostic model. Erasmus MC and Netherlands Institute for Health Sciences 58

61 Health Sciences & Clinical Research for Medical Students increasing the knowledge of the roles that prognostic models may play in clinical practice and the critical factors that determine the validity of predictions from a prognostic model. gain insight in the pitfalls in prognostic model development with standard statistical techniques. acquire knowledge on advanced statistical techniques in prognostic model development and validation. EWP16: Prognostic Research Scheduled: 4-8 March 2013 Faculty: O. Akre, MD PhD ECTS: 0.9 In this course I will give an introduction to prognostic models. We will read and understand studies presenting predicitive models, how they are done and how to critically appraise them. Basic concepts, such as survival, the life table, and the Kaplan-Meier method will be covered during the first day, and we will make one Kaplan-Meier estimation by hand. Design topics in studies where prognosis is the studied outcome will also be discussed, for example potential biases in comparing prognostic data between places and over time periods. understanding the basic concepts in prognosis research. EWP22: Biostatistics for clinicians Scheduled: 25 Feb 1 March 2013 Faculty: Prof. Geert Verbeke ECTS: 1.0 This course aims at introducing the basics of biostatistics, form an applied bio-medical perspective. Starting from some data sets collected to answer specific research questions, the objectives of statistical inference will be illustrated. These examples will also serve as key examples throughout the course. Further, concepts such as population, random sample, randomization, and causality will be briefly discussed. Next, descriptive tools such as tables, graphs and summary statistics will be introduced. A lot of emphasis will be put on the relation between the population and the sample, and on how observed effects in the sample can be generalized to the total population. After having discussed the concept of sampling distributions, confidence intervals and hypothesis testing will be introduced from an intuitive perspective. Afterwards, some frequently used testing procedures (unpaired and paired t- tests, chi-squared and Fisher exact tests, McNemar test) will be presented. Specific topics will be discussed, including power and sample size analysis, equivalence testing, multiple testing, onesided versus two-sided tests, significance versus relevance, measures for association (correlation, relative risk, odds ratio), and aspects of non-parametric statistics. Finally, the analysis of survival data will be discussed, including the complication of censoring, Kaplan-Meier estimation, and logrank and wilcoxon tests. All topics covered in the course will be illustrated using real data, and a lot of attention will be given to the use and misuse of statistics in the bio-medical literature. Emphasis is on correct interpretation of statistical results, rather than on mathematical detail. getting familiar with basic statistical concepts (population versus sample, causality, p-values, confidence intervals); getting familiar with the most frequently encountered statistical techniques (descriptive statistics, tests, measures of association); being able to correctly interpret statistics results reported in the bio-medical literature. This course is equivalent to Introduction to Data-analysis (ESP03). 59 Study Guide

62 EWP23: Regression analysis for clinicians Scheduled: 4 8 March 2013 Faculty: Brian Leroux Prerequisites: An introductory course in Biostatistics such as the Winter Programme course Biostatistics for Clinicians EWP22 or the Summer Programme course 'Introduction to Data-analysis ESP03'. ECTS: 1.9 This intermediate level course introduces the fundamental concepts of regression analysis. A unified approach to regression is taken, which emphasizes the common features of regression for quantitative and discrete response variables. The course emphasizes the proper formulation and interpretation of regression models and uses several data examples from various health science fields to illustrate the concepts. Specific types of models illustrated by example will include linear regression, analysis of variance, logistic regression, relative risk regression, and Poisson regression. The course also emphasizes the assumptions of regression analysis and the impact of violations of the assumptions on inference. As one example of this, robust variance estimates will be used to minimize assumptions about the response variance. A brief introduction to regression analysis of multi-level clustered data will also be given. Assigned readings will be included in the course materials. The course will include an afternoon computer lab session where the students will gain experience in performing and interpreting various types of regression analysis using STATA. This course is equivalent to Regression Analysis (ESP09) in August. EWP24: Survival analysis for clinicians Scheduled: March 2013 Faculty: Dimitris Rizopoulos, PhD Prerequisites: Knowledge of the following topics would be helpful: basic statistical concepts (e.g., random variables, estimation, standard errors, standard statistical tests, etc.), linear regression, familiarity with R(not required but useful) ECTS: 1.9 The aim of this course is to introduce participants to the statistical analysis of time-to-event outcomes. The course will be explanatory rather than mathematically rigorous. Sufficient detail will be given such that the participants will have a clear view on the different survival analysis approaches, and how they should be used in practice. To this end, the majority of the concepts introduced in the course will be illustrated in the R statistical language using package Rcmdr. The course consists of five parts: In Part I we refer to the special characteristics of event time data (e.g., skewness, censoring, truncation). In Part II and III we present standard statistical tools for their analysis, including among others the Kaplan- Meier and Breslow estimators for the survival function, and the log-rank and Gehan-Wilcoxon tests. Part IV introduces regressions models for time-to-event data, such as the accelerated failure time and proportional hazard models. Part V focuses mainly on the Cox model and considers several extensions; in particular, the use of stratified Cox models, the analysis of clustered time-to-event data, and the handling of time-dependent covariates and competing risks problems. Objective: Explain the challenges in the statistical analysis of survival data Introduce accelerated failure time and Cox proportional hazards models Present several extensions of the Cox model to handle population heterogeneity, time-dependent covariates and competing risks This course is equivalent to the Erasmus Summer Programme course Survival Analysis (ESP28) in August. Erasmus MC and Netherlands Institute for Health Sciences 60

63 Health Sciences & Clinical Research for Medical Students EWP25: Principles of Epidemiologic Data Analysis Scheduled: March 2013 Faculty: Prof. K. Rothman Prerequisites: Completed NIHES Master's programme or equivalent knowledge ECTS: 0.7 The course will present the basic precepts and the principles underlying the primary methods of epidemiologic data analysis. The aim of the course is for the participant to arrive at a coherent conceptualization of the core principles of epidemiologic data analysis. This is not a statistics course; there is no emphasis on proficiency in the execution and calculation of results or how to build mathematical models. The course begins with a discussion of the principles of epidemiologic data analysis, and then progresses to a discussion of precision and validity, placing a strong emphasis on a quantitative approach to analysis, using estimation, rather than a qualitative approach based on statistical significance testing. After covering the analysis of crude data, the focus shifts to the control of confounding using stratified analysis and multivariate models. Other topics that are covered include the analysis of matched data, the evaluation of interaction, the use of multivariate summary confounder scores (including propensity scores), imputation of missing data, sensitivity analysis, and the estimation of trends in effect. The class presentations will be supplemented with discussion of selected published papers and computer assignments using the Episheet spreadsheet to illustrate key analytic concepts. Objective: Students will become conversant with the principles of estimation of epidemiologic measures from basic epidemiologic data. Students will be able to explain and demonstrate the advantages of stratified analysis as a primary approach to epidemiologic data analysis, and to use a spreadsheet program to conduct basic epidemiologic analysis of stratified data, and to interpret the results. Students will be able to describe a strategy for using regression models in epidemiologic data analysis, either using an outcome model or a model that serves as a confounder summary score. GE02: Genetic-epidemiologic Research Methods Scheduled: 24 Oct - 16 Nov 2012 Faculty: N. Amin, PhD and Prof. S. Heath, PhD Prerequisites: Genome Wide Association Analysis(ESP29), Principles of Genetic Epidemiology (ESP43), Genomics in Molecular Medicine (ESP57) and Classical Methods for Data-analysis (CC02). ECTS: 5.1 The aim of this course is to introduce participants to the basic principles of genetic epidemiological research. The first part of the course is dedicated to binary traits, covering the basics of probability theory, hypothesis testing, risk calculation in families, and principles of complex segregation analysis. The second part of the course focuses on the genetics of quantitative traits, covering the concept and estimation of heritability and basic quantitative trait linkage analysis using modern genetic analysis software such as SOLAR and MERLIN. In the third part of the course design of genetic epidemiological studies will be discussed. This will be illustrated by practical examples and an assignment to develop a study. During the third week of the course, students will work in groups on this assignment, and will prepare a presentation. introduce participants to the basic principles of genetic epidemiological research. 61 Study Guide

64 GE03: Advances in Genome-Wide Association Studies of Complex Genetic Disorders Scheduled: Febr Faculty: Prof. C.M. van Duijn, PhD, Y. Aulchenko, PhD, Professor S. Heath, PhD, Prof. D. Balding, PhD, Prof. B. Mϋller-Myhsok, P. Scheet, PhD Prerequisites: Understanding of genetic epidemiology (ESP29 level) and Statistics (regression analysis and maximum likelihood estimation); familiarity with PC-compatible computers is required. ECTS: 1.4 This 5-day advanced course aims to give an overview of new developments in the field of genome wide association studies for those with a background in genetics, epidemiology or statistics. In the first part of the course, issues concerning the design and analysis of genome-wide association (GWA) analysis will be covered using standard software such as Plink and genabel. This part will include genetics data quality control, practical GWA analysis of quantitative and binary traits, methods to detect and correct for stratification, and to model epistastasis. In the second part we will extend to an integrated approach of data analysis including esnps and new developments in the analysis of whole sequence data. Finally, we will discuss the perspectives for genetic testing in clinical practice. A major part of the teaching programme consists of hands-on exercises. gain insight in new developments in the field of genome wide association studies GE05: Family-based Genetic Analysis Scheduled: Febr.2013 Faculty: Y. Aulchenko, PhD, H. Cordell, PhD and P. Holmans, PhD Prerequisites: Basic understanding of genetic epidemiology (level ESP29) and statistics (regression analysis and maximum likelihood estimation); familiarity with PC-compatible computers is required. ECTS: 1.4 This course is organized for researchers with a background in genetic epidemiology and/or statistics. The focus of the course is on theoretical background and practical issues in model-free linkage studies of complex genetic traits. Both qualitative outcomes (e.g. diseases) as well as quantitative (continuous) traits are addressed. For quantitative traits Haseman-Elston methods and maximum likelihood estimation of variance components are discussed. Other issues covered are the inclusion of covariates, extreme sampling, and the generalization of methods based on sibling pairs to other pedigree structures. Family-based association studies, also in the context of wholegenome association analysis, will be considered, including total tests which utilise between- and within family variation, and also Transmission-Disequilibrium-like tests. The teaching program consists mainly of hands-on exercises using computer programs that are available on the Internet. Objective: To gain insight into the background and new developments in the field of family-based genetic research. GE10: Mendelian Randomization Scheduled: Spring 2013 Faculty: N. Sheehan, PhD. E. Jones, PhD, T. Palmer, PhD Prerequisites: Understanding of genetic epidemiology (ESP29 level) and Statistics (elementary probability, and regression analysis) ECTS: 0.6 This 3-day course aims to give an overview of recent developments in drawing causal inferences from epidemiological data and is aimed at individuals with a background in epidemiology or statistics. The first day will comprise a brief introduction to graphical models since these provide a natural framework for expressing and manipulating many of the concepts involved. We will then go on to causal modelling and the need for a formal causal framework before explicitly considering causal modelling in epidemiological settings. The second day will focus on instrumental variable methods with Mendelian randomisation applications as the primary example. Various theoretical issues, together with their relevance to practical applications in terms of what can and what cannot be done, will be discussed. On the final day, current topics including the use of multiple instruments, Bayesian approaches to Mendelian randomisation and implications for case-control data will be introduced. gain insight in new developments in the field of genome wide association studies. gain insight into disentangling the concepts of causation and association. Erasmus MC and Netherlands Institute for Health Sciences 62

65 Health Sciences & Clinical Research for Medical Students GE13: Next generation sequencing course Scheduled: Spring 2013 Faculty: L.C.Karssen, PhD, Prof. C.M. van Duijn, PhD,R. Kraaij, PhD, A. Stubbs, PhD, S. Koval, PhD, J. van Rooy, P. Eilers, PhD, J. van Meurs, S. Leal, N. Amin, PhD, Y. Aulchenko, PhD ECTS: 1.4 This course provides an introduction to working with Next-Generation Sequencing (NGS) data. It is aimed at people with access to aligned NGS data (i.e. lists of called SNPs, indels, etc.) who want to learn how to work with this data and what the possibilities and limitations of NGS are. Lectures will be complemented with practical sessions in which the student will gain hands-on experience with various tools and techniques. Subjects that will be covered are: NGS: an introduction to methodology and techniques Basic statistics of NGS data, e.g. coverage Dealing with files in VCF format, e.g. merging of data sets, conversion to plink format (VCFtools, GATK) Detection of structural variations like indels (123SV) Collapsed genotype analyses Finding variants with homozygous effects Segregation of rare variants in families and populations 1000 genomes project, GoNL Imputing rare variants This course does not aim to teach the basic bio-informatics analyses like alignment, SNP calling, etc. although these subjects are discussed briefly to give some background. HS02a: Analysis of Population Health Scheduled: Oct 2012, exam on 18 Nov 2012 Faculty: F. van Lenthe, PhD, Prof. A. Burdorf, ir., PhD, A. Kunst, PhD, W. Nusselder, PhD Prerequisites: Methods of Public Health Research (ESP11) ECTS: 1.9 Public Health Research: from Epidemiology to Health Promotion Module: Analysis of Population Health This module aims to teach methods to assess the health of populations at national and local levels. Students are taught to calculate, apply and interpret population-based measures of mortality, quality of life and disease occurrence. In addition, students learn methods to assess time trends in population health (e.g. APC methods) and to analyse inequalities in health between social groups. Note: HS02a, HS02b and HS02c will all be tested on 18 November After completing the course, the student is able to: quantify population health by using population-based measures of general health, based on life tables and related techniques; assess the public health impact of major diseases, by using measures on their prevalence, incidence and impact on population health; describe past trends and explore future developments in population health, by using age-period cohort analyses and other techniques; describe socio-economic and ethnic differences in population health, and apply statistical approaches to explain these differences. HS02b: Analysis of Determinants Scheduled: 29 Oct - 2 Nov 2012, exam on 18 Nov 2012 Faculty: F. van Lenthe, PhD, Prof. A. Burdorf, Ir. PhD and others. Prerequisites: Methods of Public Health Research (ESP11) and Analysis of Population Health (HS02a) ECTS: 1.9 Public Health Research: from Epidemiology to Health Promotion Module: Analysis of Determinants This module elaborates on research of the analysis of determinants of and inequalities in population health and risk factors of disease. Students will be introduced in a) current insights in the main determinants of population health and risk factors of disease, b) determinants of inequalities in population health, c) research methods for the analysis of these determinants and d) challenges for future research in these issues. 63 Study Guide

66 ability to analyse the determinants of population health and disease; ability to analyse environmental and psychosocial determinants of exposure to risk factors. HS02c: Intervention Development and Evaluation Scheduled: 5-9 Nov 2012, exam on 18 Nov 2012 Faculty: C. Kamphuis, PhD, F. van Lenthe, PhD Prerequisites: Methods of Public Health Research (ESP11), Analysis of Population Health (HS02a) and Analysis of Determinants (HS02b) ECTS: 1.9 Public Health Research: from Epidemiology to Health Promotion Module: Intervention Development and Evaluation. This module elaborates on the intervention development, implementation and evaluation phases in the model of planned promotion of public health. Students will a) be introduced to strategies and opportunities of primary and secondary prevention, b) learn how to work from determinants to interventions, i.e. how to translate determinants into intervention goals and intervention components and c) learn about the opportunities and challenges of evaluation of primary and secondary prevention interventions and d) be introduced to theory and challenges in dissemination of prevention interventions. The course uses examples from health behaviour change, cancer screening, and vaccination. to understand the important strategies for prevention; to have basic insight into the process of prevention intervention development; to have knowledge of the opportunities and barriers in evaluation of prevention interventions; to have skills to choose and apply the different research designs that can be used in evaluation of prevention intervention. HS03a: International Comparison of Health Care Systems Scheduled: Nov 2012 Faculty: D. Kringos, PhD, Prof. N. Klazinga, PhD, and invited speakers ECTS: 1.4 Insight into the structure, process and outcome of health care systems is vital to be able to implement health care reforms that are effective in improving the health system performance. International comparisons of health care systems and the underlying political, organizational and financial arrangements are a multidisciplinary research field with a mixture of quantitative and qualitative methods. This course will present the various methodological approaches and will build on recent national and international experiences with comparative research. The course starts with a clear conceptualization and definition of a health care system, definitions of key system components such as the service delivery system (through professionals and institutions), financing, role of the government and role of patients. Health system performance will be discussed in terms of effectiveness, equity and efficiency. Analytical perspectives taken will come from public health as well as from political sciences and economics. The 2009 course will also deal with the recent work of the WHO and OECD with respect to health system performance measurement and management. ability to describe basic concepts and models of health care organisation and delivery; ability to discuss these concepts and models from a public health and policy perspective; ability to make a comparison of health care systems from different perspectives; ability to make an analysis of one's own health care system. HS04: Medical Demography Scheduled: Feb 2013 Faculty: Prerequisites: Public Health Research Methods (HS02) or equivalent. In addition, a basic proficiency in the use of spreadsheets is required. ECTS: 1.1 The first day of the course will start with a number of basic projection techniques used in demography, and illustrate these techniques with the prediction of future trends in life expectancy. Next, the student will learn to apply the life table, which is a simple yet powerful technique to study the population dynamics underlying public health. Erasmus MC and Netherlands Institute for Health Sciences 64

67 Health Sciences & Clinical Research for Medical Students The second day will focus on summary measures that combine mortality and morbidity estimates, such as healthy life expectancies and disability-adjusted life expectancy. It will discuss two types of life tables that are used to this end: the Sullivan life tables, and the multi-state life tables. Attention is also given to assessing the effect on population health of specific diseases, such as stroke or cancer. The third day will discuss the use of risk factor models, which are applied to assess the ways in which changes in risk factors such as smoking and overweight could affect population health. Examples will be based on the Prevent model. This dynamic model is especially designed to assess the timing of future changes in population health. The last day will illustrate the use of population health models in a series of studies that evaluated the population health impact of different types of interventions. We will apply a broad model used to compare different preventive policies, and next apply another model to evaluate the health benefits of prevention of obesity. HS05: Planning and Evaluation of Screening Scheduled: April 2013 Faculty: Prof. H. de Koning, Phd ECTS: 1.4 This course focuses on the design and the evaluation of health care programmes for the early detection of disease or screening. Early detection takes place within a demographical-epidemiological context. Basic concepts include improvement of prognosis by early detection, life years saved, and other effect measures. The test characteristics will have consequences for the favourable and unfavourable effects of screening. There are a number of designs for the assessment of the effectiveness of screening, such as randomized-controlled trials, observational prospective studies and case control studies. Evaluation methodologies, such as costeffectiveness, cost-utility and technology assessment are available, including the concepts of quality adjustment of life years and of time preference. Detailed case studies include cervical, breast and prostate cancer screening, genetic screening, youth health care and screening for tuberculosis, e.g. for high risk groups. Several computer aids for the evaluation of screening are presented. At the end of this course, one should have obtained understanding of and insight in: determinants for effectiveness; measures for effectiveness of screening, levels of evidence for effectiveness, trial designs, implementation of trials; possible negative side effects, determinants of side effects; measurement of quality of life, quality adjustment of life years; the use of models for data analysis (describing the underlying natural history of the disease) and for predictions; definition of high risk groups; cost effectiveness analysis, optimization of strategies, time preference. HS09: Maternal and Child Health Scheduled: March 2013 Faculty: Prof. H. Raat, PhD Prerequisites: Introductory level epidemiology ECTS: 0.9 The health of women of child bearing age and of children has an important impetus on public health. The aim of the course is to provide an insight into child health from conception onwards. Determinants of fecundity, pregnancy and pregnancy outcome are discussed as a prerequisite for child health. Perinatal and infant mortality in an international perspective, growth and development are discussed as important health indicators. Preventive interventions such as vaccinations, screening programmes and health promotion are discussed. Special attention is given to the health of groups at risk for health problems such as children of low socio-economic classes and children of ethnic minorities. Psychosocial health problems are said to be on the increase. Facts and figures in an international perspective will be presented. In adolescence, life style habits are developed and appropriate health promotion is important. Examples of health promotion programmes are discussed. The programme consists of presentations, exercises and group discussions. 65 Study Guide

68 Topics covered: 1) Determinants of fecundity, pregnancy and pregnancy outcome. 2) Perinatal and infant mortality. 3) Growth and development preventive interventions. 4) Psycho-social health problems. 5) The health of groups at risk. 6) Adolescence and health promotion. gain insight into child health from conception onwards. HS11: Quality of Life Measurement Scheduled: 3 5 April 2013 Faculty: Prof. J. Passchier, PhD, Prof. J. van Busschbach, PhD Prerequisites: Introductory level epidemiology ECTS: 0.9 In recent years, the patient's assessment of quality of life has developed to an important target in epidemiology and health services research. Moreover, quality of life measures are also more and more used as criteria in reimbursement policy, most notably in QALY-analysis. The aim of the course is to provide the candidates firstly, with the knowledge required for the evaluation of quality of life instruments and to select the measures which are both valid and sensitive for their research purposes. Quality of life measurement will be presented from a clinical perspective (trials), epidemiology (population level) and a health economics perspective. As most investigations are done from more then one of those perspectives, the relation between them is discussed. After the course participants will be able to use the most common standard quality of life instruments and should be able to make their own tailored of disease specific instrument. Programme: Background of health status' and quality of life. Principles of construction of a quality of life questionnaire. Available instruments. Application. Adaptation instruments for specific research questions: increase sensitivity. QALY-analysis. Practical and ethical value of measuring quality of life in a reimbursement setting. acquire knowledge required for the evaluation of quality of life instruments and to select the measures, which are valid and sensitive for their research purposes; gain insight in the instruments currently available for description and valuation of health; acquire knowledge required for the justified application in evaluation research. HS15: Health Services: Research and Practice Scheduled: Spring 2013 Faculty: D. Kringos, PhD, Prof. N. Klazinga, PhD Prerequisites: Methods of Health Services Research (ESP42) or equivalent course. ECTS: 0.9 The course explores the various hurdles in linking the principles of health services research with the realities of practice. Researchers will be taught how to become more sensitive to the information needs of practitioners, managers and policy makers and how to make their studies more practice-oriented while balancing methodological requirements. The various steps of the research cycle will be discussed (formulation of the research question, study design, datacollection, analysis and presentation of results), and for each step the focus will be on the research-practice interface. In addition to classical research plans, the activities before the study is designed and the follow-up activities to promote implementation in practice, will be highlighted. Special emphasis will be put on the independent role of the researcher in the various forms of evaluation research. The course will be a combination of lectures and exercises and on the third day participants will be asked to present their own practice-based health services research proposal. This module is offered in cooperation with the CaRe research school and is developed at the request of ZonMw (Netherlands Organisation for Health Research). increasing the knowledge of researchers on the interaction between health services research and practice during the various stages of the health process; developing skills to optimise the relation between health services research and practice; working on a more practice oriented attitude of health services researchers. HS17: Ethnicity, Health and Health Care Erasmus MC and Netherlands Institute for Health Sciences 66

69 Health Sciences & Clinical Research for Medical Students Scheduled: 4-7 Febr Faculty: S. Denktas, PhD, H. Wildschut, MD, Prof. F. Verhulst, PhD, Prof. E. Steegers, PhD, Prof. J. Mackenbach, PhD, M. Foets, PhD, Prof. H. Entzinger, Phd, W. Devillé, PhD and Prof. G. Bonsel, PhD ECTS: 1.1 The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, and political belief, economic or social condition. Unfortunately, this goal, set by the WHO in 1946, has not yet been achieved. Inequalities in health still exist. This is in particular true for the health status of migrants. The last 3 decades, the developed world has witnessed a large influx of migrants and refugees from lesser-developed countries, with many of them at increased risk of poor health. There are several reasons for the ethnic income-related health gap in the developed world. These include inequalities in the access to health care services and in the provision of quality of care. What strategies need to be designed to combat inequalities in health? This course will focus on a comprehensive scientific update of estimates of the burden of disease among migrants, recent insights into the explanation of ethnic disparities in health, and on strategies to improve health, in particular of those most in need. Besides, the programme aims at providing insight into specific strategies to do research among these groups. measuring ethnic disparities in health; understanding the determinants of ethnic disparities in health; developing strategies for research among ethnic minority groups; evaluating the potential impact of interventions for the improvement of health. HS18: From problem to solution in public health Scheduled: April 2013 Faculty: E. van Beeck, PhD, Prof. D. van de Meenh, PhD and invited speakers ECTS: 1.1 The current challenges in public health require a strong link between science, policy and practice. This link is bidirectional. Professionals in practice can use their vast experience to guide better and more targeted research. Policy makers can identify which solutions may work or not and researchers can provide better evidence for public health programmes. In two Master Classes experienced researchers and policy makers will work together with participants on major public health problems. The public health problems selected are addiction & substance use, and injuries. Through intensive interaction participants will learn (1) how to make a comprehensive analysis of the problem, (2) how this analysis will guide the required evidence-base for tackling the problems, and (3) how to plan and evaluate appropriate preventive interventions. The Master Classes are restricted to 25 participants and will require an intense, active participation. MP05: Preventing Failed Interventions in Behavioral Research Scheduled: 8-12 April 2013 Faculty: A. van t Spijker, PhD, L.E. de Graaf ECTS: 1.4 Course information is t.b.a. PU03: Site Visit to the Municipal Health Service Rotterdam Scheduled: 14 June 2013 Faculty: Prof. T. Voorham, PhD ECTS: 0.3 The site visit is a orientation on public health practice in the Netherlands. The visit will be to the Municipal Public Health Service of Rotterdam (GGD Rotterdam). The objective is to provide the participant with a brief insight on how the GGD is organized and which services are provided to the community. After the field visit the participant is able to describe the learning experience regarding the visit in a structured report and to compare the services provided by the GGD and the way that these services are implemented with public health services in the participant's country of origin or country of work. 67 Study Guide

70 providing a brief insight on how the GGD is organized and which services are provided to the community; ability to describe the learning experience regarding the visit in a structured report and to compare the services provided by the GGD and the way that these services are implemented with the public health services in the participant's country of origin or country of work. PU04: Integration module Scheduled: 25 June 2013 Faculty: Prof. A. Burdorf, Ir. PhD, and the research supervisors of the students in the Public Health programme. ECTS: 0.3 Masters' students in Public Health will have to demonstrate their ability to integrate the various perspectives, concepts and approaches that have been taught during the programme. This is done on the basis of a (draft) research paper that every candidate as to write during the second half of the programme. Students will be asked to make a presentation of the results of their research, and to present their views about the implications of these results for public health. These presentations will be followed by a discussion with faculty and fellow students. ability to integrate various perspectives, concepts and approaches that have been taught in the master's of Public Health programme; ability to formulate implications of research projects for public health. PU06: Public Health in Low and Middle Income Countries Scheduled: May/June 2013 Faculty: Wilma Stolk, PhD, Jan Hendrik Richardus, PhD, Prof. A. Burdorf, ir, PhD and invited speakers ECTS: 3.0 This module aims to teach methods to assess the health of populations in low and middel income countries and to quantitatively evaluate the effects of interventions on population health. Students are taught use modern techniques as health impact assessment to predict changes in population health due to particular programmes, for example control programmes for infectious diseases. This module will be given in conjunction with the institute for Health Policy and Management (ibmg). After completion the student is able to: quantify population health by using population-based; measures of general health, based on life tables and related techniques; describe past trends and explore future developments in population health; assess the public health impact of intervention progammes through health impact assessment SC01: English Language Scheduled: 17 August 10 Oct 2012 Faculty: M. Menten ECTS: 1.4 All full-time international Master of Science students, whose native language is not English, are required to attend the first session of English Language (SC01). Your level of English will then be determined and, if proven necessary, you will be registered for the entire course. to be able to complete the educational programme without major difficulties with the English language. SC02: Introduction to Medical Writing Scheduled: 10-13, 27 & 28 June 2013 Faculty: A. Bless and I. Cressie ECTS: 1.1 During the second semester, full time Master of Science students will attend six workshops of three hours on how to write correct and readable scientific articles in English. Each student will be able to work on his or her own article, which the teacher will correct. Erasmus MC and Netherlands Institute for Health Sciences 68

71 Health Sciences & Clinical Research for Medical Students Students from institutes participating in of affiliates with NIHES, including PhD candidates at Erasmus MC, do not attend SC02; they could consider the Erasmus Summer Programme course: 'Why and How of Readable Articles'. After the course students should be able to write correct and readable scientific articles in English. SC07: Scientific Writing in English for Publication Scheduled: 14 & 28 Nov and 12 Dec 2012 Faculty: Lee Ann Weeks ECTS: 2.0 'Writing to be read' This course will focus on designing and organizing a scientific article for publication and finishing a scientific article for publication. In other words, the course is 'goal oriented' making your paper publishable. The course consists of 3 half-day sessions (morning lectures and afternoon workshops) and 4 writing assignments that will receive individual feedback from the instructor as well as other course participants. Attending all 3 sessions and completing all writing assignments is compulsory. The course will be intensive writing takes time so we suggest that participants reserve considerable time for this course. Participants will be required to write a, more or less, complete article for publication. They will be guided through the writing process in 4 writing assignments: 1. Clarifying the point of the research 2. A skeleton of the paper clarifying the main messages of the Introduction, Methods, Results, and Discussion sections 3. Abstract and Title 4. A part of your article, incorporating all of the corrections/suggestions that the instructor and the peer reviewers make. Part of the work will be 'peer reviewing.' Participants will critically discuss each of the four assignments with a partner (another course participant). Furthermore, participants will review and critique the articles of others in peer reviewing groups. This implies that participants must be willing to work closely with a partner during the course and meet deadlines for peer reviewing. After revising texts based on these reviews, they then send them to the instructor. He will do some editing, give practical tips, and suggest improvements Objective: The course provides the participants with skills and tools to write credible, readable and citable research papers for publication in English. Unique for this course, the participants receive extensive individual feedback on their own papers. SC09: Linux for Scientists Scheduled: 22 & 23 October 2012 Faculty: L. Karssen, PhD ECTS: 0.6 This course aims to teach users of a Linux/UNIX system how to work with the command line interface. After an introduction to some history and basic concepts the basic commands for file and directory manipulation will be discussed. Subsequently, the students will learn how to manage processes as well as input and output redirection, followed by more advanced text processing utilities like 'sed' and 'gawk'. The second half of the course shows how to write Bash shell scripts to automate tasks. This knowledge is then used when discussing the Sun Grid Engine job queue system in use on the epib-genstat servers. The course will focus on providing hands-on experience, so those who have been using a Linux system for a longer time will be able to skip the parts they already feel comfortable with and move on to more advanced concepts like regular expressions, version control and advanced use of a text editor. After completing this course, the students should be able to efficiently use a Linux system and its tools to: manage your project data from the command line (i.e. without having to copy files back and forth to the server); reformat output from previous analyses and use this as input for a subsequent analysis step; write scripts that automate repetitive tasks; efficiently run time-consuming analyses like a GWAS without overloading the server. No previous Linux knowledge is expected, however, on order to gain most from the course it is recommended to have done a few analyses on a Linux server already. 69 Study Guide

72 SC17: Courses for the Quantitive Researcher Scheduled: Nov 2012 Faculty: Prof. E. Lesaffre, PhD, D. Rizopoulos, PhD, and S.P. Willemsen Prerequisites: Basic level epidemiology and biostatistics. ECTS: 1.4 The aim of this course is to prepare Nihes MSc students for the more advanced statistical courses (i.e., Repeated Measurements, and Survival Analysis in the Erasmus Winter Programme, Bayesian Statistics, Missing Values in Clinical Research and Growth Models) by equipping them with the required knowledge of basic statistical concepts and statistical software. The course consists of three parts: 1. basic concepts in mathematics and statistics; 2. introduction to the R statistical software and 3. a brief introduction to the SAS language. The first part covers essential concepts in statistics such as density and distribution function, types of distribution functions, integral calculations, differentiation, notions of matrix theory, optimization topics applied to likelihood and sampling. The second part, which is done in conjunction with the first one, introduces the R programming language that is used to perform data manipulations, graphics and statistical analyses. In the third part a brief introduction will be given of the SAS package with an emphasis on basic data manipulations. Objective: at the end of the course the student will be equipped with the required knowledge of basic statistical concepts and statistical software to successfully complete the advanced statistical courses. Erasmus MC and Netherlands Institute for Health Sciences 70

73 Health Sciences & Clinical Research for Medical Students Colophon Editing Mrs N.W. Schrofer Cover design Bureau mdm. Erasmus MC & Netherlands Institute for Health Sciences PO Box CA Rotterdam The Netherlands 71 Study Guide