By Kathy Franklin
Sally Noone, RN, MSN, is one of the most respected professionals in the field of food allergy. She has worked in allergy research for 21 years, at Johns Hopkins and at Mount Sinai, and has co-authored 20 publications, including “Dietary baked milk accelerates the resolution of cow’s milk allergy in children,” “Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2),” “Development and validation of educational materials for food allergy” and “Dietary baked egg accelerates resolution of egg allergy in children,” published this month in the Journal of Allergy and Clinical Immunology. The recipient of numerous awards, Sally was recently honored with the American Academy of Allergy, Asthma and Immunology’s Allied Professionals Recognition Award, and with her third Mount Sinai Medical Center Employee Recognition Service Award. Sally was kind enough to take some time out of her very busy schedule to speak with me about her work, her career, and the latest research news.
From Patients to Paperwork: Running a Clinical Trial
Sally Noone has served since 2005 as Clinical Research Manager at the Jaffe Food Allergy Institute. She is currently the Clinical Research Coordinator on two studies, Milk Oral Immunotherapy (OIT) plus Xolair® (omalizumab, anti-IgE) and Food Protein-Induced Enterocolitis Syndrome (FPIES).
What is a Clinical Research Coordinator? The CRC is the primary patient contact for a research study. She answers questions about the research from anyone interested in learning more, including parents, prospective volunteers, allergists, pediatricians, and even inquiring bloggers; she screens patients who wish to participate, seeing whether they qualify for a study; and she gives them all the information they need to decide whether a study is right for them. Sally encourages the patient to generate a list of research-related questions to ask their own physician, to help them better evaluate the potential risks and rewards of the treatment. Should someone decide to volunteer for the research, the CRC walks them through all the consent forms, and handles all scheduling. (As you can see, this job involves a lot of paperwork and a lot of phone calls!) When the patient begins a trial, the CRC is in charge, along with the study doctor, and spends a great deal of time with the patient, administering the treatment and monitoring their progress. Each visit generates a lot more paperwork. The CRC also keeps in contact with the patient between visits. She must keep track of all “adverse events” — everything from a cold to a rash to a sprained ankle must be recorded, monitored, and reported.
The Clinical Research Coordinator also is responsible for the annual submission to the IRB, the Institutional Review Board, which regulates and monitors all human research, ensuring that each study is safe, scientifically sound, and meets all ethical standards. The IRB requires that the doctors and nurses running the study are highly qualified, and ensures the risks to patients are minimized and the potential benefits are maximized. Every change in a study protocol, large or small, requires approval from the IRB. For example, reimbursement for transportation and free parking for study participants for Milk OIT has been added. They will cover local Metro North or Long Island Rail Road train costs, or transportation to and from a local airport. (Yes, people fly in from other cities to be part of this groundbreaking research, although airfare is not reimbursed.) Since that was not part of the original proposal, covering those costs required new IRB approval (and new paperwork for the CRC) before it could be instituted.
In addition to her own two studies, Sally supervises all of the other CRCs at the Jaffe Food Allergy Institute, who are working on other ongoing allergy studies. The CRCs work very closely together, and each of them is qualified to work on any study, so if Sally has too many visits scheduled on the same day, another CRC can see one of her patients that day. They all share responsibilities for all the studies. If a CRC knows she will be away the next time the patient is scheduled, she will introduce the patient to the person who will be covering them.
Sally has always shared her time and knowledge with her colleagues and the community; she is a tireless advocate and educator. She recently gave three workshops/symposia at the annual AAAAI meeting, on GI Allergies, on Food Challenges, and on Patient Recruitment and Retention. This generosity and dedication has drawn high praise from professionals. Our contributor Anne F. Russell BSN, RN, AE-C Faculty, Spring Arbor University Department of Nursing says: “Sally has a wealth of food allergy clinical, educational and research experience. She has generously shared her abundant clinical expertise with me, and many others. She is not only a trailblazer in the field of food allergy science but also in the Profession of Nursing.”
Educating School Nurses
Sally also presents to school nurses at FAAN Conferences. “More than anything, school nurses need support. They know what to do medically in an emergency, but they need a lot of reassurance that they know what they know. It’s a tremendous responsibility, and they feel that responsibility. Sometimes they feel a lack of support, and feel that they have to rely on the families for their food allergy information.” Sally recommends three new web-based teaching initiatives as an important source of support for school nurses. FAAN & FAI have collaborated on a free, interactive online course available at http://allergyready.com. There is also a training module at http://www.allergyhome.org/schools. CoFAR, the Consortium of Food Allergy research, provides information online in their Food Allergy Education Program, at https://web.emmes.com/study/cofar/EducationProgram.htm. While the CoFAR teaching tools are primarily for parents, Sally recommends the site to school nurses as a good way for them to see what parents are learning.
A common complaint among school nurses is that parents of food-allergic students are obsessively concerned about their children’s health and safety. Nurse Sally makes a special point of explaining to them that these parents are not “hyper.” “For the most part, school nurses don’t see a serious allergic reaction. The ‘hyper’ mother has seen her child have a serious reaction. This isn’t ‘hyper’ anything, it’s appropriate behavior and it’s necessary.”
This concern for the feelings of parents is widely recognized by those who work with her. Mary Jane Marchisotto, Executive Director of the Food Allergy Initiative says, “Sally has been a source of compassion and information about food allergies for thousands of families. She also plays a key role in educating health professionals and recruiting patients for important clinical trials. For all of us at FAI, it is a privilege to work with her and learn from her.”
While food allergy education and awareness have “gotten better,” Sally is still regularly invited to speak at schools, particularly at the beginning of the school year. She’s happy to oblige, but her busy schedule only allows her to speak in the evenings or late afternoons; other MSSM staff also will speak on food allergy at local schools whenever possible.
From Research to Therapies
Sally is excited by the current progress in research. “For the first time, we are starting to work on therapies. It seems to be within striking distance, that there might be something to offer other than strict avoidance. For example, the baked milk and baked egg studies have been amazing for people, many of whom can now safely eat milk and eggs.” [For those not familiar with these studies, researchers have found a way to introduce small amounts of well-baked milk or egg to highly-milk and egg-allergic patients, gradually increasing the doses – under strict medical supervision – until the patient is eating the foods, even unbaked, with no allergic reactions. Sally calls it “amazing”; several participants I have spoken with call it “life-changing.”]
What’s been the biggest surprise in conducting research? “I thought the shots [in the Milk Allergy Research with Xolair] would be the biggest turn-off for my patients, especially the younger ones. But after the first shot, it just wasn’t that big a deal to the kids. I have 7- and 8-year-old patients who don’t make any fuss about shots. I thought that would be a much bigger deal with the kids than it is.”
Another pleasant surprise for Sally is that “parents are our best recruiters and resources. Many parents have spontaneously offered to talk to other parents, explaining how the research experience was for them, sharing mealtime strategies, tips on how their children successfully managed to take their daily doses at sleep-away camp, and generally offering to be useful to other families participating in the study. That has been a huge positive.”
Does Sally have any allergies of her own?
“I don’t have any food allergies. I always thought I had a nickel allergy, because I can’t wear jewelry without getting a rash, but recently was tested by a dermatologist, and it turns out I’m allergic to gold, not nickel.” Her other allergy, ironic for an allergy researcher, is to hydrocortisone.
If there were more hours in the day, how would Sally use them? “See more patients, and make more phone calls to patients.”