Capstone Project An advocate’s role in research The content, context, and effectiveness of participation Jane Baker Segelken INTRODUCTION Since the National Breast Cancer Coalition (NBCC)1 first began its efforts towards the eradication of breast cancer through advocacy and action by ensuring, among other things, that breast cancer activists are at “every table where decisions regarding breast cancer are made,”2 the perspective of the patient has been considered. Discussions concerning relevance, purpose, and translation have occurred in a variety of venues and about a variety of issues related to breast cancer. This paper will specifically address a phenomenon of the early 1990s — the inclusion of people living with breast cancer and other lay advocates (those who are not biomedical professionals) on panels that decide how research dollars are allocated. Increasingly, the advocate’s role in research is viewed as vital to making certain the dialogue stays focused on the needs of women at high risk for or living with breast cancer, on how the research will affect the greater breast cancer community, and on the goal of eradicating the disease (Fiscal 2006; Platner 2002). While I have participated as a breast cancer activist in the scientific and political arenas since 1998, my journey began in October 1996 just two days before my 42nd birthday and six-months after having a clear mammogram. It had never occurred to me that I might some day be diagnosed with breast cancer. No close blood relative had ever been stricken and the risk factors I had were considered small. With my diagnosis, however, I realized I had no one with whom I could talk. Everyone I knew who’d had breast cancer was dead. And those who had not had the disease knew as much or less about it than I. I confided in a friend who knew of a local support organization3 that was started a few years before by breast cancer survivors who generously shared their knowledge and gave support to the newly diagnosed. Those women helped me learn how others experienced the disease and how decisions were made. I immersed myself in learning all I could and educated myself in the language of breast cancer. At first I became a strong selfadvocate. Then, inspired by the women I met who were living with the disease I began seeking ways I could contribute on a broader level. In November 2000, I completed the NBCC’s Project L.E.A.D. (Leadership, Education, Advocacy, and Development), a science-training course that taught me the language research scientists use, trained me how to critically appraise scientific literature, and offered me insight into the tools I would need to help influence research and public policy processes. Since then, I have participated as a patient advocate on several review panels where research studies are funded. In the past three years — by participating on panels and through discussion with other advocates and scientists — I learned more about the advocate’s role in research. Because of those interactions and the ensuring conversations, I decided to explore if and how the process works, and what improvements, if any, were needed. METHOD Between July 2003 and July 2005, I had the chance to personally speak with approximately 18 scientists and at least 25 advocates about their experience serving on research review panels. The scientists included medical doctors (oncologist, surgeon), epidemiologists, microbiologists, sociologists, immunologists, geneticists, nurses, biologists, pathologists, biochemists, science writers, and others. The consumers were primarily women and men who had been diagnosed with breast cancer and who had become involved in local and/or national advocacy organizations. A few consumers were staffers of advocacy organizations (Komen and California do not require reviewers to have had personal experience with breast cancer). In conversations, I told both the scientists and the advocates that I was planning to do a paper on the process and asked if they would mind answering questions. At other times, I simply listened to discussions around me between advocates, scientists, and advocates and scientists, taking notes on what I observed. In March 2005, I devised two qualitative surveys (Appendix 1), one for scientists and one for advocates. I E-mailed the scientists survey to nine researchers I’d met but had not spoken directly with, and E-mailed the advocates survey to five advocates I’d recently met. In addition, I posted a notice on the Project L.E.A.D listserv and the Patient Advocates in Research (PAIR) listserv asking advocates who wanted to be involved in the project to contact me for the survey. Five scientists and 18 advocates responded to the written survey. Everyone who spoke with me or answered questions — whether in one-to-one conversation or via written survey — agreed to do so on the condition their comments would be kept confidential and only printed in this paper. In an E-mail to those I asked to complete the written survey I wrote: “While this is an informal survey for a class paper, I want to assure everyone up front that all answers are completely confidential and I will not use your name or any details that would in any way identify you. This paper is for a class project and I do not intend it to be seen by anyone but my professor. That being said, if I ever decide to publish all or part of the paper, I will contact you for your consent to use your feedback (anonymously) before proceeding.” Some of the comments presented here are paraphrased from my conversations at the various panel meetings; others are taken from the written surveys. The responses of those with whom I talked or who answered the survey are included in this paper in italic form. THE ROAD TO RESEARCH ADVOCACY When people ask I often say that my experience with breast cancer made me, first, my own strongest advocate and now an ally of others. I am not a scientist or a researcher. I am simply a woman who has lived with breast cancer since 1996 who was privileged to have an incredible amount of personal, social, and professional support, and who has been lucky enough to have been involved with a number of advocacy activities including those that encourage the participation of advocates in the design of research and policy agenda’s. Although I had learned the language of breast cancer and had made a point of reading articles about current research, my formal connection began in November 2000 when I participated in the NBCC Project L.E.A.D4 program. During four days, I received a thorough overview of the subjects deemed necessary to prepare me “with the basic knowledge and background to critically appraise research proposals and policy initiatives” (NBCC). Those topics included human biology, genetics, and epidemiology, as well as training on how to participate in the scientific community as a breast cancer advocate. Project L.E.A.D. “graduates” have access to journal articles and discussion sessions. Advocates have participated in a variety of training programs instead of or in addition to Project LEAD. Some have attended conferences and workshops, such as the San Antonio Breast Cancer Symposium and the American Association of Cancer Researchers Scientist to Survivor Program, where they have interacted with researchers while learning the current state of breast cancer research. Others have participated in trainings offered by the Cochrane Collaboration, American Cancer Society, and the National Cancer Institute’s Consumer Advocates in Research and Related Activities Program. But as Deborah Collyar noted: “The best training, of course, is ‘hands-on’ training with the researchers that advocates work with. Nothing can replace the conversations, laboratory tours, suggested articles and direct explanations to relevant concepts that patient advocates can learn from while working directly with researchers to see how their environment affects their ability to develop discoveries into deliverables for cancer patients” (Collyar, 2005). In response to lobbying by breast cancer advocates — led by the National Breast Cancer Coalition — the DoD created the Congressionally Directed Medical Research Programs (CDMRP) in 1992 when $25 million was allocated to fund research on the screening and diagnosis of breast cancer among military women and dependents. Since then, the CDMRP has expanded to become second only to the National Cancer Institute as a source of funding for breast cancer research5, and now manages research programs in neurofibromatosis, prostate cancer, ovarian cancer, tuberous sclerosis complex, chronic myelogenous leukemia, and prion diseases. Although a few funding mechanisms (primarily private) do not convene panels to review applications or include advocates on their teams, there are numerous opportunities for breast cancer advocates to serve as reviewers on research review panels and as advisors to organizations and companies funding research. Among them, the Department of Defense (DoD) Congressionally-mandated Breast Cancer Research Program, Susan G. Komen Breast Cancer Foundation, Inc., California Breast Cancer Research Program, Avon Foundation Breast CareFund, National Cancer Institute’s Consumer Advocates in Research and Related Activities program and other NCI standing and ad hoc advisory groups, advisory committees of the Food and Drug Administration, NYS Health Research Science Board, American Cancer Society, and others. Nearly all limit the number of consecutive times advocates can serve (the average is three consecutive years6); advocates can rotate off for a few years and can then rejoin the panel if asked. The pay ranges from $0 to about $1,250. Although each organization and agency that funds breast cancer research has its own guidelines regarding how advocates are chosen to serve on their panels, most require applicants have some preparatory training (e.g., Project L.E.A.D.) and be actively involved in an organization made up of those affected by the disease. The latter requirement, according to one DoD representative, is designed to ensure the advocate represents the views of the larger community and “not just his or her own agenda.” In some instances, advocates can apply for their own to serve on panels or committees. At other times, they must be sponsored by the disease-specific organization. My first chance to officially use my newly acquired skills came in July 2003, when I was one of 82 advocates chosen nationwide to serve on the DoD Breast Cancer Research Program. The Ithaca Breast Cancer Alliance submitted an application on my behalf, which included a two-page essay from me about why I wanted to serve and what I thought I would contribute to the panel (Appendix 2). On four different occasions, I served with the DoD Program (immunology, cell biology, Era of Hope Scholars, and Era of Hope Innovators panels), once on a Susan G. Komen Breast Cancer Foundation, Inc. panel (tumor cell biology), and twice with the California Breast Cancer Research Program on the CRC/Socio-cultural, Behavioral, Psych & Health Policy panel (Appendix 3). Role All panel members, whether advocates or scientists, are considered full voting members. The roles they play differ: advocates review the grant proposals and judge them from the perspective of the person at high risk for or living with breast cancer; scientists review the grant proposals and judge the scientific merits (see Criteria). All participate in panel discussions and rate the quality of the proposals. Of the three organizations I’ve reviewed for, the DoD is the only that provides each new panel member with a mentor whose primary function is to provide support prior to and during the review process. From both the advocate and scientist perspective, this is an important function; one scientist suggested it should be a part of all grant proposal reviews: • Make sure they [advocates] have training, perhaps have them observe a panel before participating in full, start out with fewer proposals to review and with a more experienced “buddy” to help reinforce the mechanics of the process. However, I was disappointed by how I was mentored. The person assigned the task by the DoD never contacted me or the other advocate on the panel until the day before the meeting, despite the fact we both called and e-mailed him several times. Following the panel meeting, I was offered the opportunity to provide feedback on all aspects of the meeting and I shared my experience with the assigned mentor. I learned mentors are offered guidance on how to help their peers be successful both before and during the panel sessions. And I was assured better procedures would be implemented the following year. In 2004, I was asked to serve on another DoD panel and to mentor three women who had never served before. Guidelines that covered very basic procedural issues were provided each mentor. Because of my experience the previous year, I offered to each new reviewer details I’d wish I’d had. Via e-mail, I contacted the three women I mentored when I received my assignment and arranged to have a telephone conversation with each to discuss expectations and peer review responsibilities, strategies and suggestions for managing time, and the approaches they might take to present the patient perspective at the review meeting. In addition, we talked about resources available when reviewing the proposals in advance of the meeting and the mechanics of writing up the critiques. During the three weeks leading to the meeting, we communicated regularly. About a week before the meeting, I sent some last minute reminders: “It's freezing cold in the rooms at the hotel so bring a sweater or light jacket. Some people even bring socks” … “Although you do not need to bring your computer. I did last year and found it to be helpful as I could see on my screen all the proposals we were reviewing at the time they were being discussed” … “Usually the full panel dines together the night of the first full day we're together. If for some reason we don’t this year why don’t the four of us plan to get together” … “I’m available via telephone or e-mail so contact me with any last minute questions or concerns.” Preparation So, how does someone with minimal scientific background prepare to participate on breast cancer grant review panels? Attending Project L.E.A.D. is invaluable, although I found the science information I learned there became out of date quickly. Reading articles and attending conferences is important. But I believe what is most vital is that we know our constituency and represent their needs and goals fully. In other words, advocates should consider how relevant the research is to those living with breast cancer and evaluate the appropriateness of the proposed protocol. The DoD requires advocate reviewers have some formal training in basic science, as well as “first-hand experience with breast cancer, and accomplishments and commitment to breast cancer advocacy.” I believe that good advocates draw upon their personal experiences but not to the exclusion of others. The most effective advocates articulate the opinions of those at high risk for or who live with breast cancer as well as their own. It is clear that the reason government agencies and many organizations that place advocates on their scientific peer review panels want them to be involved in breast cancer advocacy and support organizations is so they can share a broader perspective than they might otherwise be able to do. Advocates’ views varied when asked this question, “How were you prepared/trained to participate in the research review panels and do you believe your training was adequate for the type of reviews you have done:” • Project L.E.A.D. [introduced me to the] scientific concepts and analytical tools to evaluate research, and Journal Club increased that knowledge and honed those skills. Attendance at conferences exposed me to the world of research in a setting where I could converse with scientists to discuss their work, observe scientific controversies, increase my knowledge, and be aware of the newest, cutting-edge research and thinking. Being a survivor gave me a unique perspective on relevance and the importance of research. Group experience gave me a broader perspective on breast cancer issues and concerns. • Not really ... You get better with reviewing with each new session and meeting and discussing with other advocates. Training alone is not adequate - you have to attend seminars, etc. • I believe that my training is better than adequate for the type of review I have done so far. • No. I felt that the Project L.E.A.D. training was a good introduction but I learned by doing. With each review, I gained a better grasp of what was needed and how I could be of greater service to the other reviewers. • Not really - one would have to learn a lot more basic science to fully understand the content, and be familiar with the specific field of research. However, we can often comment on the potential relevance of the research to patients. When an advocate is accepted onto a DoD review panel, she or he is instructed to “ignore the science” and have confidence that the scientists on the panel will ensure its validity. Applicants are expected to include a lay abstract written in simple language with their application, but many do not prepare the document as instructed. Other applicants do provide a simply written abstract, but oftentimes that document is so whitewashed it is impossible to get a true sense of the research being proposed. It is unrealistic to expect advocates to proceed without a modicum of awareness and understanding of the science; without such insight it would be impossible to determine whether the research has disease relevancy, etc. It is incumbent upon the funding agency/organization to ensure the lay abstract is written clearly and comprehensively. And as part of the initial review process7 the funders should get rid of those proposals that are deemed scientifically unsound before reviewers are asked to judge whether they should be funded or not. Advocates have different opinions regarding the “ignore the science” mandate: • At first, I was insulted, but the more reviews I do, the more I learn from the scientists and realize that I only have a basic knowledge of some of the science. I now read the scientific portions and if I can glean that something is wrong, I will mention it in my write-up. Research is changing so rapidly that it is important to have the best researchers in each field at the reviews. • I do not assume that the science is good ... I was trained to question its quality; nobody will change my attitude on that. • I think it makes a lot of sense. Advocates are there to provide input on other matters. The expected results of the study need to be commented upon by advocates. • There's really no choice about this, is there? In general, scientists agreed that advocates were invaluable at the table and helped humanize the research. One researcher reminded advocates they “don’t have to talk like a scientist.” It is more important, this researcher added, that advocates “Remind I prepare for the reviews by quickly looking at each proposal and then putting them in an order that makes sense to me.9 Because of my minimal scientific background, I began my own personal “dictionary” of technical terms when I did my first review — the list grows with every new panel. I make sure I have my references close by and that my on-line websites are bookmarked and accessible. Once I begin to read a proposal, I look first at both the lay and technical abstracts. Then I quickly read the body of the proposal looking for things such as why the researcher is interested in breast cancer research, whether the researcher’s professional and educational experience is relevant to the proposal and what else he or she has done, the proposed research’s relevancy to breast cancer, and stated goals and expected outcomes. Often I want to know who benefits: age, gender, and race. I may read one or more of the articles cited for background. Generally, I look at the applicant’s vita and the letters of recommendation. I only read and score one proposal at a time because it’s too confusing otherwise. How advocates approach the proposal reviews vary: • I read the abstracts, both lay and scientific, for an overview with the scoring criteria in mind and then read the proposal for details. I then think about the substance and context of the proposal, again with the scoring criteria in mind. • [I look for] good abstracts (lay and scientific). No cut and pasting of paragraphs in an effort to cut corners. I hate re-reading the exact same things because the applicant was too lazy to answer the question in a different way … clear and meaningful graphs and visuals … letters of recommendation from mentor or collaborators … reaching outside the field for collaborative opportunities … a plan for success with the project. • Tried to read both lay and technical abstracts, recommendation letters, and CV, and glanced at the budget. I also tried to read some of the proposals, but if they were too technical, I omitted that step. Generally, I tossed out any review articles to cut down on the amount of material I was handling. • [I] read the proposals several times. Make notes while reading. Envision myself or a family member participating. • I read the papers and SEARCH pubmed.gov for others on the topic. I am usually unable to find all the papers referenced and of course can only get the abstracts. Criteria Advocate representatives on grant proposal review panels generally are instructed to assess the relevancy to breast cancer in general and breast cancer patients specifically; to determine the short-term and long-term implications of the research for those at high risk for breast cancer, those undergoing treatment, and those living with breast cancer; and to consider the potential impact of the research. Essentially, advocates are expected to provide information that only someone who’s been there — has lived with breast cancer (as a survivor, patient, family member, or person at risk in the community) — can give. Here’s what advocates say they include in their criteria for a meritorious research proposal: • Projects that make sense for the patient. Will it be something that they are willing to participate in? Will it be painful/stressful? Is it do-able? Are the results going to be fairly quick or 20 years down the road? Is it a shot in the dark or does it have some background work that shows merit? • How that proposal will impact survival, quality of life, detection and possible cure for breast cancer. Is it specific for breast cancer, or could this be funded for any type of cancers ... if so, let the scientist find his funds elsewhere, and save these funds for [breast cancer]. • Potential clinical relevance is most important to me. Integrity, solid background, prior research, realistic goals, vision. • Inclusion of common sense, translational possibilities, meaning. Beyond criteria of relevancy, I found myself as a professional writer making another kind of judgment: I believe it is essential that the proposal be free of spelling and grammatical errors, and be written in a clear and concise fashion. The reason for this is I have no confidence in the thoroughness and conscientiousness of someone who doesn’t take the time and care to make sure the submitted proposal is the best it can be. I can’t help but wonder if a sloppy proposal an indication of a lack of attention to quality science? I am aware, as other panelists have commented, that many proposals come from foreign-born researchers. As far as I am concerned, that is no excuse. Every university has a department to assist in the preparation of grant proposals, and every computer and word processing program has a spelling and grammar checker. At least one other advocate agrees: • Personal quirk - I hate typos and poorly composed proposals. If it's important enough to ask for money, write it well. Although most of the proposals I have reviewed involve laboratory research or surveys, I have commented on a handful that involve clinical trials. When presented with a clinical trial proposal, I take a hard look at the trial design and carefully consider how the applicant wrote up that part of the proposal to determine the level of passion for and understanding of the clinical trial participant. How the applicant communicates in his or her proposal may be a clue to how he or she will communicate with the patient. One advocate said she looks for: • … inclusion of sensitivity toward women with breast cancer, especially in regards to various cultural issues for underserved communities. The grant applications As has been mentioned, the format of the application goes a long way in helping advocates judge the research proposal. In addition to an abstract written specifically for the layperson, some advocates suggested that grant applications should include charts and graphs as a way of illustrating the intent and expected outcomes. Many advocates offered other ideas about what applicants could include in the proposal that would help advocates better understand the intent and purpose of the proposal: (Please See Part II below) Advocate's Role in Research Part II (includes footnotes) By Jane Baker Segelken Advocate References for An Advocate's Role in Research Article by Jane Baker Segelken Appendix I for An Advocate's Role in Research From article by Jane Baker Segelken Appendix II An Advocate's Role in Research From article by Jane Baker Segelken Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.