A Study to Evaluate the Intra-rater and Inter-rater reliability of the Pemphigus Disease Area Index (PDAI) and the Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) for Use by Dermatologists
To download and print the Informed Consent Form, click HERE.
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Dr. Victoria Werth is looking for PV & PF patients with active oral or skin lesions to participate in an upcoming one-day study – August 4, 2007 at the University of PA, Philadelphia. Dr. Werth and a team of doctors are working to finalize an outcome study of the IPPF Definitions Committee. When this study is completed, words to describe our disease may finally be defined medically – remission, control, etc., and used by dermatologists in describing our disease activity.
Anyone with more than three active lesions or one large active lesion (greater than 10 mm(3/8 inch)in size) can be part of the study. If you are with in driving distance or Amtrak distance from Philadelphia, this study welcomes you. There will be a $95 stipend and a parking validation for your involvement.
If you would like to be a part of this upcoming research project, read the rest of this page, download the Informed Consent Form, and contact Joyce Okawa, RN, or Matt Rose at (215) 898-0168 who will discuss the consent form and research study with you.
This study is meant to evaluate whether dermatologists, who are skin doctors, can use the PDAI easily and as well as another physician. In addition, this tool will be compared to the ABSIS to see which is superior. We hope that these research tools can be used by dermatologists for conducting research trials aimed at helping those with pemphigus. We need to show that some dermatologists who use the score will come to similar results when they examine and score the same patients. It has been determined that at least 10 physicians are needed to complete these evaluations on a minimum of 10 subjects to validate these tools. Therefore you will have to be examined by about 10 physicians on one day. These physicians will use two or more of the above tools to examine and measure your skin disease activity, while you will complete the Patient Pain, Itch, and Skin Related Health questionnaire independently. They will examine your skin and discuss your disease with you. They will take pictures of your skin activity to use in the future for teaching or investigational purposes, as well as for publications related to this study.
It can be very hard to judge the severity of a skin disease. Frequently two physicians as well as two patients may have very different ideas of what constitutes a serious skin disease or a relevant improvement. This is a serious problem for the evaluation of new treatments, and the lack of standardization has been identified by the Food and Drug Administration as a problem for the development of new drugs for pemphigus.
In order to make it easier to run clinical trials to evaluate new drugs, physicians have developed scores or research tools to assess the skin (for example, lupus, psoriasis, acne, and atopic eczema). Scales have been developed for pemphigus which involves the skin (cutaneous pemphigus). The scales which we will focus on are named the Pemphigus Disease Area Index (PDAI), the Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) and the Global Skin Score. We hope that these tools will be useful in helping doctors and patients decide the activity of skin pemphigus and if it is getting better or worse over time. These tools are hoped to assist with the monitoring of general disease activity.
How long will I be in the study? How many other people will be in the study?
The study procedures will be completed between 3 to 6 hours on August 4, 2007. Ten to fifteen subjects will be enrolled in the study.
What am I being asked to do?
You are being asked to come to the Dermatology Clinic at the University of Pennsylvania for a one day evaluation. A brief chart review will be conducted to confirm you meet the entry requirements of this study. If you meet all of the entry requirements, you will have your skin evaluated by approximately 10 physicians. You will also have photos taken of your skin. A questionnaire will be given to you to record on a scale from 0 to 10 the level of pain, itch, and skin related health you experience. Your responsibility is to arrive on time and plan on staying long enough (between 3 to 6 hours) for your skin to be evaluated by all of the physicians.
What are the possible risks or discomforts?
We will not use any procedure or intervention which has the potential to harm you. The study is completely non-invasive, which means that no blood or tissue samples will be taken. The physicians will evaluate your skin condition only. Despite the nature of the study, the research may involve risks that are currently unforeseeable.
What if new information becomes available about the study?
During the course of this study, we may find more information that could be important to you. This includes information that, once learned, might cause you to change your mind about being in the study. We will notify you as soon as possible if such information becomes available.
What are the possible benefits of the study?
There is no immediate personal benefit to you for participating in this study. However, this study is important for patients with pemphigus because it may help to facilitate the development of new drugs.
What other choices do I have if I do not participate?
If you decide not to participate in this study, you may continue to seek treatment for your skin disease at the Department of Dermatology at the University of Pennsylvania Medical Center.
Will I be paid for being in this study?
You will be compensated for costs associated with travel to the clinic. You will be paid $95 for attending all required sessions and will receive free parking in Penn Tower at the University of Pennsylvania through a validated parking ticket.
Will I have to pay for anything?
You will have to pay for transportation to the outpatient Dermatology Clinic at the Hospital of the University of Pennsylvania.
What happens if I am injured or hurt during the study?
We do not anticipate any condition or situation that may cause you injury or illness on the study day.
In the event that you are hurt or injured as a result of participation in this research study, please contact the investigator listed on page one of this form.
In the event of any physical injury resulting from research procedures, medical treatment will be provided without cost to you, but financial compensation is not otherwise offered from the University of Pennsylvania. If you have an illness or injury during this research trial that is not directly related to your participation in this study, you and/or your insurance will be responsible for the cost of the medical care of that illness or injury.
When is the Study over? Can I leave the Study before it ends?
This study is expected to end after all participants have completed all visits and all information has been collected. As mentioned previously, the study is expected to last from 3 to 6 hours on one day. This study may also be stopped at any time by Dr. Werth without your consent because:
– The Principal Investigator feels it is necessary for your health or safety. Such an action would not require your consent, but you will be informed if such a decision is made and the reason for this decision.
– You have not followed study instructions.
– The Principal Investigator has decided to stop the study.
If you decide not to participate, you are free to leave the study at anytime. Withdrawal will not interfere with your future care.
Who can see or use my information? How will my personal information be protected?
We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. Please refer to the separate "HIPAA Privacy Authorization" document that explains more specifically how your personal information will be protected.
Who can I call with questions, complaints or if I’m concerned about my rights as a research subject?
If you have questions, concerns or complaints regarding your participation in this research study or if you have any questions about your rights as a research subject, you should speak with the Principal Investigator by calling 215-898-0168. If a member of the research team cannot be reached or you want to talk to someone other than those working on the study, you may contact the Office of Regulatory Affairs with any question, concerns or complaints at the University of Pennsylvania by calling (215) 898-2614.