Invitation to participate in a research study on serious cutaneous adverse drug reactions (SCAR)
We are writing to tell you about a research study being conducted at Brigham and Women's Hospital and Massachusetts General Hospital. The study is conducted by Dr. Li Zhou (Division of General Internal Medicine and Primary Care, BWH) and Dr. Kimberly Blumenthal (Division of Rheumatology, Allergy and Immunology, MGH).
What is this study about?
We are studying what clinical and genetic factors increases a person's chances of developing serious cutaneous adverse drug reactions (SCARs). We develop standardized methods for identifying individuals who may have had a SCAR episode from electronic health records (EHRs) using advanced informatics technology. We also aim to identify which risk factors increases a person's chances of developing SCAR and study the possible effects of SCAR on the health, quality of life and treatment. We hope to better understand how to promote safe drug prescribing to minimize such severe reactions from occurring and to improve care of patients with SCAR.
What is your involvement?
We are contacting you because the medical records indicate that you may have experienced a serious cutaneous adverse drug reaction (SCAR) in the past. As an individual who may have experienced a SCAR in the past, we would like to invite you to participate in this study.
Participation would involve the following:
1. Participating in a short screening phone call from a member of our research team. This screening phone call will take approximately five minutes.
2. You may be asked for consent to obtain your health records
3. You may be asked to complete one or more short surveys
4. You may be asked to provide a saliva sample for genetic analysis, and
5. If you have experienced drug reaction with eosinophilia and systemic symptoms (DRESS), you may be asked to participate in an interview. The interview will take approximately thirty minutes
No in-person study visits are required. Those who complete the study (i.e., provide consent for health records, complete surveys and provide a saliva sample) will receive $30 for their time.
Those who complete the interview will receive an additional $30 for their time. There is no compensation for participating in the screening call. You will not receive any personal health benefits as a result of your participation in this study.
Participation is voluntary. If you choose not to participate in this study, your healthcare will not be affected in any way at Brigham and Women's Hospital, Massachusetts General Hospital and any of the Mass General Brigham (formerly Partners Healthcare). We hope that the results will help us better understand the factors that are associated with serious allergic reactions and how to improve counselling and care of patients who may have an increased chance of developing a SCAR.
If you are interested in hearing more about the research study or joining the study, please contact the project coordinator, at scarmterms@BWH.HARVARD.EDU or 857-282-4090. If you do not want to participate or hear more about the study, please return the enclosed postage-paid notecard. If we don't receive the card within 2 weeks from the date noted on the letter/email, a member of the research staff may send you another letter or call you on the phone to see if you might wish to hear more about the study.
We thank you for considering this request and participation in the research study.
Sincerely,
Li Zhou, MD, PhD, Principal Investigator, Division of General Internal Medicine, Brigham and Women's Hospital
Kimberly Blumenthal, MD, MSc, Site Investigator, Massachusetts General Hospital
Daniela Kroshinsky, M.D, MPH, Co-Investigator, Massachusetts General Hospital
If you would like to donwload a copy of the letter please click on the link below.