THE R.A.C.E.R. COMRADES MARATHON STUDY: PART 1
Dear Marathon Runner,
Hi! My name is Professor Efraim Kramer, the Head of the Division of Emergency Medicine and honorary professor in Exercise Science and Sports Medicine at the University of the Witwatersrand (Wits).
The intention of this information leaflet is to highlight the research that I am doing into the topic of cardiac complications that may occur to marathon runners, particularly during and after training and competition. You may have been aware lately of various athletes and footballers who have collapsed during sports activities requiring cardiopulmonary resuscitation (CPR). This collapse was due to a sudden cardiac arrest and it may be caused by an undiagnosed, inherited cardiac abnormality. I must emphasize at this point that the incidence of such an event is rare, but it has already occurred in two school children in South Africa this year and at the Comrades Marathon a few years ago, and should be prevented by all possible means.
It is therefore my wish to undertake a research study of marathon runners, specifically runners who will be running in the Comrades Marathon 2013 and/or 2014 in order to try and discover what activities or factors, if any, play a role in causing a particular marathon runner to develop an adverse cardiac event, such as a sudden cardiac arrest on a particular day, during a particular race and not before. Nobody knows why a heart may develop a problem during exercise at the moment that it does, and this research is meant to try and see if we can discover these risks, and if we do, prevent these events from happening.
In order to do this, Part 1 of this study involves monitoring your running schedule and medical history for the 6 months before, whilst you train for, the 2013 Comrades Marathon and if possible for the 2014 as well. I would like to send you an email every week on a Monday with a questionnaire inside the body of the email. All that you have to do is to click on your REPLY button on your email, complete the questionnaire with any information that is relevant for that passed week and then click the SEND button. The questionnaire asks questions about any illnesses or injuries that you may have had that passed week, any medicines or supplements that you may have taken, the number of hours of running you did and anything else that was unusual that week. I really do not wish to be interfering with your normal life at all, but this is the only way that I can try and discover what the risk factors are that may be influencing runners in general.
A month before the Comrades Marathon, I will send you a medical questionnaire for you to complete and also invite you to participate in Part 2 of the R.A.C.E.R. study, which will involve a post-race medical examination process, the exact details of which I will explain when the invitation email is distributed in early May 2013.
Please be aware that all of the information obtained weekly will be kept strictly confidential and in an anonymous format. Only I and a dedicated small team of medical researchers from the Wits University Medical School will have access to this information. This study, like all others conducted by Wits University, will be conducted under the full ethical standards and clearance of the Wits University, Human Research Ethics Committee approval.
Like all research, there is no obligation for you to take part in this research. If you would like to be part of the R.A.C.E.R STUDY, after reading this letter, please send me an email to firstname.lastname@example.org saying that you have read the R.A.C.E.R information letter and agree to participate. This email will be accepted as giving informed consent to become involved in this research study. Even if you initially consent, you are free to withdraw at any point in the process.
If you do decide to withdraw from either the Comrades Marathon or the R.A.C.E.R. study for medical reasons, I would request that this information be communicated to me so that I may ask a few questions that may be important to the study. However you are not obliged to answer any questions if you choose not to. There are no costs to you for any part of this study nor any financial gain.
Should you have any questions, queries or concerns, please do not hesitate to contact me directly or the Wits University Human Research Ethics Committee.
Prof Efraim B Kramer
Head: Division of Emergency Medicine
University of the Witwatersrand.
Prof Efraim B. Kramer Prof Peter Cleaton-Jones
Head: Division of Emergency Medicine Chair: Human Research Ethics Committee
Email: email@example.com Email: Peter.Cleaton-Jones@wits.ac.za
Telephone: +27 849111999 Telephone: +27 11 717 2301
Telefax: +27 865533447