Eczema Comparative Effectiveness Research
Adapted from www.primr.orgDue Monday December 11 by 5 pm15 points reference the federal regulations as appropriate. Eczema is a chronic skin disorder that involves scaly and itchy rashes, as well as blistering, weeping, or peeling of the skin. It is diagnosed by visual inspection of
the skin and patient history. No tests are needed. While eczema is not a deadly or disabling condition, it can make life miserable for its sufferers. It often can be
successfully treated with lotions and creams and, in cases that do not respond to these treatments, with oral corticosteroids. When these treatments are not successful
dermatologists use “phototherapy,” which involves exposing the affected area of skin to Ultraviolet B (UVB) light over several sessions. Phototherapy has been shown to
be an effective form of treatment. Exposure to UVB light is like an intense exposure to sunlight. What is not known is the best dosage of UVB exposure for treating
eczema. The American Eczema Association recommends that physicians use four units of UVB light two times a week until they see the improvement they are looking for in
the patient. This recommendation is based on a consensus of dermatologists, but there are no clinical trials that prove that this is the best dosage. Doctors at
Innovation Medical Center (IMC) use eight units of UVB three times a week and believe, based on their three years of experience with this higher dosage, that this
regimen is more effective than the lower dose with no added risk. The IMC doctors would like to prove this. The IMC doctors propose a randomized clinical trial in which their eczema patients (they treat people ages 7 and up with UVB) would be assigned to the four-unit or
eight-unit dosage arm for six weeks (about the usual time for the treatment to be completed). The researchers would like to offer the subjects the option of undergoing
a 4mm punch biopsy of the affected area before the first treatment session, at week three, and during the last study session in order to observe the cellular level
changes caused by the different dosage regimens. However, subjects can be in the research study without agreeing to the biopsies. Subjects who agree to the biopsies
would receive $50.00 for each biopsy. Excerpts from the proposed informed consent form:• You are being asked to participate in this study because your doctor has recommended phototherapy to treat your eczema, but does not know the best way to
choose UVB doses for you. By participating in this clinical trial, you will help to determine the ideal way of treating psoriasis with phototherapy. • While the American Eczema Association recommends using low doses of UVB, some dermatologists, including all IMC dermatologists, use higher doses of UVB to
achieve a better treatment response. There is no scientific data available to know which of these two treatment approaches are better for the treatment of eczema. • If you agree to have skin samples (a skin biopsy) taken, there will be risks involved with this procedure. A skin biopsy is a minimally invasive procedure. It
is commonly used in standard clinical practice to diagnose skin diseases and to evaluate treatment responses. A four-millimeter punch skin biopsy is a relatively small
and quick procedure, but it requires local anesthesia and sutures. Risks associated with skin biopsies include bleeding, allergic reactions to local anesthesia,
infection, and scar formation. Bleeding from skin biopsies is usually minimal and easy to control using pressure. Allergic reactions to local anesthesia are very rare,
but potentially severe. The dermatology clinic is equipped with the appropriate equipment for emergency interventions if needed. The rate of infection at biopsy sites
is very low and limited to the biopsy site. A small scar will result from the biopsy. Biopsy sites will be chosen to minimize the cosmetic impact of such scars. The
skin biopsy is optional and not required to participate in the study. • Phototherapy with UVB carries certain risks, including burning, skin dryness, tanning, pruritus (itchiness), and skin carcinogenesis. The “high-dose” regimen
has been the standard of clinical care at IMC for several years. The “low-dose” regimen is recommended by the American Academy of Dermatology and was recently
published as guidelines for nbUVB phototherapy. Subjects treated with UVB in this study will have no increased risks from phototherapy as compared to patients treated
with UVB under regular care outside of this study. Playing the role of an IRB reviewer for this study, please answer the following questions (and provide adequate justification for your arguments):  1) Is there equipoise in this study? Is it ethical for researchers to randomize participants to one of the two treatments in this clinical trial? (Answer in
approximately 500 words, worth 5 points) 2) Evaluate the consent language and provide suggestions for improvement and additional language. (5 points) (Answer in 500-1000 words, worth 5 points) 3) Should the biopsies be included in the study? Is the payment appropriate? (Answer in 300 words or less, worth 2.5 points) 4) Are there any inclusion/exclusion criteria that should be added? (Answer in 300 words or less, worth 2.5 points)