- CHOP —
- Children’s Hospital of Philadelphia
- PBRN —
- Practice-based research network
- PeRC —
- Pediatric Research Consortium
Practice-based research networks (PBRNs) are ongoing collaborations of clinicians and researchers to conduct studies that improve clinical practice and patient health. PBRNs have long emphasized input from clinicians as a key component of practice-based research. For example, the American Academy of Pediatrics Pediatric Research in Office Settings network relies on practitioners, as opposed to investigators or administrators, to decide which studies are approved.1 In recent years, the importance of getting input from additional stakeholders, especially patients and their families, has been increasingly prioritized. Patient engagement in research may lead to increased study enrollment rates and greater relevance of study outcomes to families.2 The 2010 Patient Protection and Affordable Care Act funded the creation of the Patient-Centered Outcomes Research Institute, which promotes clinical effectiveness research with sustained engagement of patients, families, and other stakeholders throughout the research process.3 Given this focus, practice-based research studies in which researchers partner with patients and families have become more common. However, models for meaningfully and efficiently engaging parents in pediatric PBRN research decisions, regardless of funder, are needed.4
The Children’s Hospital of Philadelphia (CHOP) created the Pediatric Research Consortium (PeRC) Parent Advisory Board to gather input from families that is used to inform the implementation of practice-based studies. PeRC is a 31-practice, 2-state PBRN involving 205 physicians and 41 nurse practitioners. PeRC includes a diverse population of patients from urban, suburban, and more rural practice settings. To date, 95 research projects have been completed in conjunction with parents. In this article, we describe the partnership between PBRN leaders, researchers, and parents that created and sustains the Parent Advisory Board.
Creation of the Partnership
Alexander Fiks, PeRC Medical Director
We focused on establishing a feasible level of commitment from parents and a convenient process through which they could provide feedback and participate. To ensure that the board included a manageable and diverse number of participants, we initially included 5 parent volunteers. We purposefully invited parents from different practice settings and backgrounds to gather diverse perspectives. To join the board, parents had to commit to 12 months of participation. Parents received a $300 stipend in 2 installments; the first was given after completion of all institutional paperwork, and the second was given at the end of the 12-month term. This was meant to recognize parents’ commitment to the network and its research. All parents completed an initial orientation and training program.
Parents were offered the opportunity to meet with mentor parents who had previous experience advising the health system. They attended a 2-hour formal training session in which parents learned how to use their personal story to educate health system staff on family-centered care and provide feedback in a collaborative manner. Because the goal was not to replicate the institutional review board review process (which occurs separately), but rather to provide a unique parent perspective, Collaborative Institutional Training Initiative training was not included in the onboarding process. As part of this initial orientation, studies were discussed with each parent over the phone to build comfort with the review process. Participation on the board involved providing feedback on new studies within 2 weeks of a request to review. Parents also joined twice-yearly, 1-hour PBRN board meetings.
Erica Evans, Parent Advisory Board Member
I wanted to join the board in part because it helps me give back to the institution that’s helped me for the past 25 years, but also because the work we do is so important. Research needs several perspectives to look at the whole person, especially the emotional component and how a study affects the daily life of a parent and child. You can’t make that up; you need people who have that experience.
Melanie Cutler, Parent Advisory Board Member
Since CHOP has done so much for my family and so many other families, I’m always looking for ways to give back to them however I can. With that said, I’m a working mom of two, so I cannot say yes to every opportunity. When I was approached about participating in their newly created PeRC Parent Advisory Board, I felt honored but questioned whether I could keep up with it. Luckily, the time commitment and level of effort sounded minimal while the potential impact could be very high, so I happily signed on. As I came to learn more about the research board, it struck me as such a smart, common sense idea to have parents involved in the design of research projects. After all, sometimes even the most brilliant researchers can be out of touch with the nuances and practicalities of working with a child. It’s so important to give children a voice, especially when it comes to their minds, bodies, and medical care. Plus, as all parents know, if something involving kids isn’t kid-friendly, it’s not likely to succeed!
Kimberly Mehler, Parent Advisory Board Member
I am on the board because I think parent feedback is very useful to young doctors who might not have children yet or understand the needs of children with particular issues. Parents know their children better than anyone, and we can help the research doctors design better studies. It is really important work. Along with all the other work they are doing, I particularly admire preventive measures that researchers look into, such as teens and birth control or driving studies.
Parent Review Process
We detail the workflow for parent review of proposed research studies in Fig 1. We modified the PeRC research study intake form (previously oriented to members of the health system) so that the study objectives would be readily understandable to parent members (Table 1) who also were sent the full proposal. The new lay language also appealed to existing reviewers who were administrators or clinical team members. When any new study involving prospective research in PeRC begins the institutional review board process, each Parent Advisory Board member receives an e-mail communication summarizing the highlights of the study and a preliminary assessment from the PBRN director. Next, a survey link is e-mailed to each parent to enter their assessment of the study (Fig 2). This process is fully integrated into the PeRC approval process. No prospective studies can move forward in PeRC until all Parent Advisory Board members who participate in the review (generally at least 2) approve the study. Despite the need for increased review, this process has not slowed down the network’s research approval process. All initial study assessments from parents have been completed within 3 business days, although subsequent discussion often lasts longer.
When a study comes along, we simply wear our “mom” or “dad” hats and read the description as if our own children are being asked to participate. I look at the study’s objective, recruitment practices, number of visits, and of course, what will actually happen during visits. As I read through a given study design, I ask myself questions such as, Would I subject my children to this treatment? Would my child be able to tolerate this type of visit? Would I schlep my child to this location this number of times within this time frame? and Do I believe this study is worthwhile and could benefit other children? If my answers are yes, I give it the green light. But if I feel like some aspect of the study doesn’t sit right with me, I give my honest opinion because if I see an issue, I’m fairly confident there will be other parents out there who will feel the same way. For example, there was 1 study that required the participants to do an MRI. Because MRIs can be loud and potentially scary to a young child, not to mention they require sitting still for extended periods, I wasn’t sure if I would subject my own children to an MRI as part of a research study. Instead of voting “yes” or “no,” I selected “other,” then wrote in a comment that I had no issue with the study itself, and that I was sure there were parents who would be willing to have their children participate, but that I personally would probably not sign up my children for that particular study.
The process of reviewing a study starts when Jim sends us an e-mail with background information about the study. Then we receive a second e-mail that links to a Web-based survey. We answer the question, “Is this a research study you and/or your child would participate in?” If the answer is “yes,” we select from a list of reasons why we would participate. We have the option to write in a response before we click “submit.” If the answer is “no,” we again select from a list of reasons, then list specific things that could be done differently to change our minds. The whole process usually only takes about 5 minutes (if that). That said, I do my best to be thoughtful in my decisions because I realize that my feedback can potentially impact a researcher’s hard work.
James Massey, PeRC Network Director
Between June 2014 and December 2017, the PeRC Parent Advisory Board reviewed 95 research studies. Although the focus of the Parent Advisory Board is the preliminary review of studies for their relevance and appropriateness for family participation, members also have had the opportunity to build on this work and become involved in all aspects of the research process. Studies reviewed by the Parent Advisory Board sometimes have parent partners on the investigative team. Participation in one does not preclude the other. For example, the board assisted in the development of questionnaires used in a research study of food insecurity. In addition, members participated in designing the research plan and developing a measurement tool for a study examining parent perceptions of respiratory virus transmission in pediatric primary care practices.
Parent review of research studies also has led to the identification of potential issues that would not have otherwise been addressed. For example, when reviewing a proposed study that used social media–based support groups to treat postpartum depression, parents raised concerns about the use of Facebook for support groups as opposed to in-person sessions. We informed the study principal investigator of these concerns and connected the parents and the investigator in an e-mail discussion. After a joint review of the literature with the Parent Advisory Board members, all concerns were addressed by the study investigators and the protocol, benefitting from parent feedback, was approved. Of note, to ensure parents feel comfortable providing feedback, parent responses to investigators are aggregated and anonymous.
There have been a handful of times when I needed more or clearer information to make an informed decision, in which case I have followed-up with Jim before submitting a response. There were 1 or 2 study summaries that were written using fairly heavy “doctor speak,” so I had to ask Jim to translate. Another study, required children to undergo a magnetoencephalography (MEG) brain scan in which they would be required to sit in a chair with a helmet for 3 to 4 hours. It required some soul-searching on my part to decide whether I would subject my children to the intervention or whether it would be fair for other children to receive the intervention.
I never said no to a study, but I did hesitate with concerns a few times. One had to do with an MRI, and another involved putting a healthy child in a control group, so I thought it might be hard to recruit. I know that CHOP can’t offer a lot in compensation for ethical reasons, but the studies with a higher burden on families to participate usually have more compensation, so that helps. My concerns were always addressed and/or explained.
I appreciate that they take what we say to heart and put it into their study plans. They come back to us if they need to, and they follow-up and let us know what they’ve done with the information we provided. The reverse is also true. There was 1 study that I needed more information on. It involved the use of a medical device in a young age group. I knew there were potential risks involved, so I said no at first. Jim followed-up and provided more background information to the group. After reading more and speaking to the study team, I decided that the device could in fact be beneficial to the patient.
I have always felt that my input to the Parent Advisory Board is valued. The fact that the program exists and that CHOP takes the time to solicit feedback tells me that they genuinely take parent opinions seriously. The investigators I’ve spoken to actually seem eager to have their studies “blessed” by actual parents, possibly because that feedback can potentially make the study more viable.
Serving on this board is a great way to hear about interesting studies while helping to shape them for the better. It’s a win-win in my book.
When our partnership began, our primary goal was to ensure that the program was feasible, meaningful to parents, and helpful to investigators. We asked parents for a short-term commitment as a test of the process. Since that time, all parent partners have remained involved, indicating that the current program is feasible and sustainable. However, as parents gather experience, we have an opportunity to deepen the partnership and broaden opportunities for parents to become more fully engaged with research teams. PeRC leaders and parents will meet to explore these opportunities and continue to innovate the program in coming months.
Little has been written about the process of systematically engaging parents in decisions about whether PBRN research studies should proceed. In addition, parent perceptions are not readily available in published literature about network research. By taking steps to provide initial support and training, minimize the burden of participation, and keep parents meaningfully engaged, PeRC’s Parent Advisory Board provides a model for parent engagement in research that may be adapted to other pediatric research settings where family engagement that transcends individual studies is a priority. At the same time, it provides an opportunity for meaningful, fulfilling, and evolving partnership between parents, network leadership, and researchers to support pediatric research and improve care.
We thank Erica Evans, Kimberly Mehler, and Stephanie Mayne for their contributions to this article.
- Accepted August 20, 2018.
- Address correspondence to Alexander G. Fiks, MD, MSCE, Children’s Hospital of Philadelphia, Roberts Building, Room 10-471, 2716 South St, Philadelphia, PA 19146. E-mail:
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
FUNDING: No external funding.
POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.
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- Copyright © 2018 by the American Academy of Pediatrics