Vicki DiGuilio is a CERTAIN Patient Advisor working with Dr. Sara Javid on a project to identify the important issues facing women who undergo mastectomy to treat breast cancer that are not currently captured by existing patient-reported outcomes tools. We asked Vicki to tell us why it was important to her to spend her limited time partnering with CERTAIN on research projects relating to breast cancer. Here are her thoughts, in her own words:
I have worked as a supervisor in survey research on various health projects since 1992. What has always fascinated me is the fact that, at the beginning of each study, both supervisors and researchers always speculate at what respondents will think are the most important topics, and we are ALWAYS dead wrong! The undeniable fact is that people who are actually living with the issue we are studying are by far the best people to direct the researchers in their quest to make life better.
I have been battling breast cancer on and off for 19 years, and in the past, that has only meant a lump removal and the distant nagging worry in the back of my mind as to when or if cancer will crop up again. Then In 2012, I faced a left breast mastectomy and in the aftermath of such drastic surgery I found I had no idea how to get on with my life. I had tubes hanging out of me and no breast! I quit bathing. I hid in my house wearing my husband’s 3X sweatshirts and hunching forward to hide my deformity from both of us. If anyone came over, I retreated to the bedroom until they were gone. I couldn’t even stand to look at myself, let alone be seen by my friends and family. I could barely move my left arm, I couldn’t drive and none of my clothes fit. Every time I looked in the mirror, what I saw scared me. I was no longer the happy big-breasted woman who laughed all the time; instead all I saw was the pale sad face of a stranger.
I made several calls to my surgeon’s office and discovered that they were no better equipped than I was to deal with either my practical issues (e.g., where can I get a prosthetic) or my emotional ones (i.e., I am so ashamed of my body). Shortly thereafter, I received a survey in the mail asking about my surgery. I started filling it out and got mad. Really mad. As a survey researcher, I realized that the questions were so restricting. My answers to such standard questions would never tell the real story of what I was going through nor what was important that they address. I proceeded to type up a letter full of my complaints to CERTAIN Patient Voices, who sent me the survey, and mailed it off with the completed survey. For the first time in 2 weeks, I took a shower and washed my hair. From there, I did a lot of online research to help me navigate issues with my drain still left from the mastectomy and to find store that could help me with a prosthetic breast and other specialized issues.
When CERTAIN Patient Voices received my letter, Danielle Lavallee called me to ask if I would like to be involved in projects that CERTAIN is working on relating to breast cancer. I answered with a resounding YES! In my opinion, women who have been through a mastectomy need to give this research all the support and information possible. My hope is that if we come together and share our experiences with researchers, they will turn that information into valuable tools that translate into high quality post-surgery care for women struggling with this horrible disease in the future. My personal goal is that in sharing my experiences, if I can help just one other woman get through this terrible, life-changing experience, my time will be well spent.
Appendicitis is a very common condition, impacting almost 1 out of 5 people. Unless you have had your appendix removed, you are at risk for appendicitis. For over 100 years, the primary treatment for appendicitis has been the surgical removal of the appendix, called an appendectomy. In Europe, and more recently the United States, some doctors have started to challenge the notion that appendectomy is needed, instead treating with antibiotics alone. The advantage of a non-surgical approach to treatment is avoiding the risks to patients that come with surgery. However, while non-surgical treatment appears to be safe, people only receiving antibiotics remain at risk for appendicitis in the future. It is not clear if treatment with antibiotics alone is as effective as appendectomy in the long run or which treatment approach is preferred or considered better by patients.
The goal of patient-centered outcomes research (PCOR) is to assess the benefits and harms of treatment options to help inform decision-making, and the treatment of appendicitis is a great example of an area where PCOR is needed.
Given the lack of clear evidence to inform the best treatments for patients with appendicitis, surgeons at CERTAIN hospitals in Washington State are developing a study to answer this question: is treating patients with antibiotics alone as effective as appendectomy? We are looking for input from patients, clinicians, policymakers and others to guide our next steps and hope you will answer a few brief questions!
See how others taking the survey responded.
Shannon Marsh currently works as an American Cancer Society Patient Navigator at the Swedish Cancer Institute and is a recent partner to the Patient Advisory Network. Shannon has an extensive background in patient advocacy and as a patient advisor in research. In 2003, Shannon quit her practice as an appellate attorney to work at the Fred Hutchinson Cancer Research Center as a research advocate. This decision was prompted after her father received a grim prognosis of esophageal cancer at the age of 58. At that point, Shannon had already experienced her own diagnosis of a rare pediatric ovarian cancer at age 12, watched all the women on her father’s side of the family die from ovarian or breast cancer, and learned she carried the BRCA2 mutation. Her decision to become a patient research advocate was simple, she says, as “being a passive observer was no longer an option.”
To date, Shannon has worked with several cooperative groups, including the Department of Defense’s Congressionally Directed Medical Review Program for Ovarian Cancer Research, the National Cancer Institute’s GI task force, the Pacific Ovarian Cancer Research Consortium, Marsha Rivkin Center for Ovarian Cancer Research, and the Executive Advisory Panel for the Patient Advocates in Research Team (PART) for the SPORE program, and on several research studies at Seattle’s Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance.
About her work, Shannon says: “The ultimate goal in becoming a patient advisor in research is to aid in the development and funding of good science and to expedite its delivery from the bench to the bedside. We [patient advisors] do this by providing the patient perspective up front – by asking the questions that a person in the lab might not. It’s no easy task and involves learning a new language, being willing to ask the “stupid” questions, and recognizing the enormous opportunity and responsibility that comes with providing the voice for so many patients who have come before us and/or will follow us.”
Mary Scott became involved in the CERTAIN Patient Advisory Network in October 2012. Since starting her work as a Patient Advisor, Mary has actively contributed to CERTAIN. She has attended all of our Patient Advisory Network meetings, contributed to the CERTAIN PAD Study by providing input on study documents aimed at patients, and worked with CERTAIN Patient Voices Project Senior Researcher Dr. Danielle Lavallee on a new funding proposal to the Patient Centered Outcomes Research Institute (PCORI) entitled, “Comparing Engagement Techniques for Incorporating Patient Input in Research Prioritization.” In this project, she helped conceptualize study operations, particularly in providing insight on how to best engage patients to provide input on research priorities. She also assisted in drafting patient materials for the proposal.
Mary’s interest in being involved in the CERTAIN Patient Advisory Network stems from her desire to make a difference in the lives of people. She also harbors a great interest in the medical field and enjoys learning about and contributing to work to advance health. Most significantly, Mary partners with CERTAIN as a way to honor her daughter who recently passed away. Her daughter, an OB-GYN physician, was passionate about her work and active in the research community. In her spare time, Mary serves as the Editor of the Ellensburg, WA, city newsletter, “Town Talk.”
Sarah Han is a CERTAIN Patient Advisor currently working on theMobile Post-operative Wound Evaluator (mPOWEr) project. mPOWEr is a post-discharge wound surveillance mobile health (mHealth) app that encourages patients to engage in their wound management, allows surgical providers to monitor their patients post-discharge, and provides a reliable method of patient-provider communication. Sarah met mPOWEr Principal Investigator Dr. Heather Evans when she was volunteering in the Emergency Room at Harborview Medical Center. Sarah is a recent University of Washington graduate who is interested in pursuing a career as a physician, so she was initially interested in opportunities to volunteer on a research project to gain research experience. However, after talking with Dr. Evans about her ongoing research, Sarah became interested in offering a patient perspective to mPOWEr, due to her previous experience with a surgical site infection after her own surgery two years ago. Sarah began collaborating with the mPOWEr team in the Spring of 2013 and has since been involved with design of the mPOWEr application and writing additional funding applications.
When she first began working with the mPOWEr team, Sarah says that she did not immediately recognize the importance of what she had to offer to the team of highly trained and experienced researchers. But, she says, she quickly learned, “my value is my patient experience! My mere presence focuses the team with a more patient-centered approach and helps to design a tool that patients will actually use. As an advisor, I provide the patient voice and ensure that the issues most important to patients are continually represented.”
Sarah believes that patient involvement in research is extremely important. She says, “after getting involved as a Patient Advisor on mPOWEr, it occurred to me that as a patient, our stake in research isn’t in the professional capacity, but it affects us in a very personal way. Patients intimately feel the consequences of disease and illness, and research influences treatment. We can help address gaps in the healthcare system and inform the most useful interventions, yet we are a vastly underutilized resource. I truly believe that patients should not only be on the receiving end of healthcare, but also be contributors to medical research, policy-making, and practice.”
Sarah plans to use her experience with mPOWEr to continue to champion patient involvement in research as well as their own healthcare management. In the fall of 2014, Sarah will attend Stanford MedicineX, a conference that explores how emerging technologies will advance the practice of medicine, improve health, and empower patients to be active participants in their own care. She received an ePatient Scholarship to attend MedicineX, which will afford her the opportunity to connect with other patients partnering with researchers on healthcare technology projects as well as to present her work as a Patient Advisor so that others can learn from her experiences.
In this new feature, we aim to highlight the innovative and patient-centered work of other organizations at the local, regional, and national level. This is part of an ongoing effort to develop a network of Patient Advisors who are informed and educated on research and healthcare issues. For this quarter, we wanted to highlight a national effort to ensure the patient voice is represented in regulatory decisions. Do you know of an organization or initiative we should highlight? Let us know!
The US Food and Drug Administration (FDA) involves patients and patient representatives to inform efforts to ensure human drug and biologic projects are safe and effective. There are two main efforts underway at the FDA where patients are actively involved, the FDA Patient Representative program and through a new initiative for Patient-Focused Drug Development.
Patient Representatives provide the FDA with the unique perspective of both patients and family members affected by a serious or life-threatening disease. FDA Patient Representatives participate on Advisory Committees and offer the patient perspective, providing comments to assist the committee in making recommendations. Patient Representatives may also consult for review divisions when a medical product or therapy is under review or present at FDA meetings and workshops on disease-specific or regulatory and health policy issues. To learn more about the FDA Patient Representative Program check out the FDA website.
ecognizing the importance of the patient voice and the opportunity to more effectively gather patient perspectives on their disease and available treatment options, the FDA launched the Patient-Focused Drug Development Program in 2013. This initiative comes through the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V), which committed the FDA to further develop the approach for assessing the benefits and risks associated with regulatory decision making. Over a five year period, the FDA will hold a public meeting on 20 different disease areas to collect patient perspectives. Meetings planned for 2014-2015 are listed in the table below. Patients are invited to attend public meetings either in person or through web conferencing. In addition to providing input at meetings, patients can provide input through public dockets. Interested in learning more or getting involved? Learn more about meeting updates and opportunities for participation at the FDA website.
Discussions between CERTAIN Patient Advisor Vicki Diguilio and University of Washington surgeon Sara Javid resulted in the development and subsequent funding of a research project focused on improving information collected from women undergoing surgical procedures for breast cancer. In 2012, CERTAIN began collecting information about quality of life, well-being, and physical perception among women following surgery for breast cancer. The information is important to understanding how women are doing following surgery but limited in its ability to inform breast cancer quality improvement activities in an actionable way that will improve care delivery. To develop and inform a new approach, we are conducting surveys of surgeons and members of the breast cancer surgical care team to hear from them what they think are the most important aspects of quality of life (e.g., body image, physical function, emotional well-being) and treatment decision-making for them to address when treating their patients. We will also be conducting a series of focus groups with women who are up to 2 years out from having a mastectomy to treat their breast cancer, to find out what they feel is most important for surgeons to know about their patients given their experiences. If you are interested in learning more about the study, please contact us.