How Doctors’ Language in Medical Records Impacts Patient Care….. and Rare Disease Drug Development
By Blair Van Brunt
Patient advocate, Casey Quinlan, posted an article a couple of weeks ago on LinkedIn and I can’t stop thinking about it. The author of the article, Emily Bradley, wrote a blog piece about the clinical language that is used by doctors in recording patient visits that can negatively affect the direction of a patient’s care and medical community in general. The article is poignant and insightful with a dose of solution.
Emily Bradley noted a number of incidents in which her disease’s impact on her life, as well as on her financial situation and her job, forced her to miss doctor’s appointments or forego expensive treatment options. Despite her best efforts to communicate this to her doctors, when she looked at her medical records, the words she read made her feel unseen and unheard.
Can we change this practice?
“Perhaps instead of “patient failed X treatment” we can begin with “X treatment failed for patient” or incorporate more phrases such as “patient elected to…” and “patient shared X regarding medication XYZ.”
I relate to this from a rare disease mom point of view, from my job point of view - at TREND Community, trying to help patients and caregivers with their daily struggles while providing crucial patient experience data to the companies that can get them the treatments they need -and, of course, from the point of view as a patient myself.
In fact, could this language barrier also be preventing patients from gaining access into clinical trials? Is this kind of language not only hindering individual patient care, but perhaps the drug development process at large? And in the rare disease world, with so many of the diseases classified as life threatening, this is a very serious problem.
This is a heads up to all of us to:
By Sarah Inoue
Growing up, we never celebrated Mother's Day because my mother's birthday was on or near the day and because, as a family, we felt an extra day was unnecessary. I have always had mixed feelings about the holiday. On the one hand, taking time to thank someone and express one's love is always a good idea, and some people do need a reminder to do so. On the other hand, the holiday can be so difficult for non-traditional families, people without mothers, people with abusive mothers, the list of problems can be long. Once, a college friend of mine and I went out for brunch on Father's Day and the waitress asked why we didn't bring our dads - well, because her father had died ten years ago. Holidays can often seem as if they are designed to remind us that our lives are imperfect, not normal, and lacking.
I don't mean to diminish the experience of people who have wonderful Mother's Day celebrations full of wonderful presents and crafts from the kids and beautiful expressions of love. I'm so happy for you, truly. Enjoy the moment and the day fully and without guilt.
I am also, as a feminist mother, aware all the time of the amount of work mothers in the USA have to do - the Mental Load - without either strong infrastructure and society support and sometimes without spousal support. I'm constantly trying to un-gender parenting. The person who started Mother's Day, Anna Jarvis, according to Wikipedia, "envisioned a day venerating the daily services and sacrifices of mothers within the homeervices and sacrifices of mothers within the home" (https://en.wikipedia.org/wiki/Mother%27s_Day_(United_States)).
In my work with the rare community, I notice that mothers often bear the brunt of the work taking care of the child with a disease and this can overtake their other work and change the course of their lives and their careers. In some ways, this can be a beautiful undertaking, where mothers help the whole community and our society deal with these illnesses, but in other ways, it is may be just another way that our society depends on unpaid work to solve problems no one wants to look at.
In 2017, on Mother's Day, Rare Disease Report recognized the work of some of these mothers. I hope these stories make all of us feel better about ourselves and our lives and what we can accomplish. I applaud these women and everyone dealing with rare disease.
As mother day approaches, one of our TREND Community members reminded us today that rare disease can have a huge impact on the mother/child relationship. She asked some very powerful questions and we would like to extend them to all of our rare disease groups.
If you are a child living with a rare disease, how has the disease affected your relationship with your mother?
If you are a parent of a child with a rare disease, how do you think your child’s diagnosis has shaped your relationship with him/her?
If you have other children, how do you think rare disease has impacted their relationship with you?
In a few words how has living with rare disease impacted your family?
Please feel free to share any other thoughts relevant to this topic.
If you would like to participate, please login to TREND and add begin a new journal entry with #mothersday. If you are not yet a member of TREND Community, you can join on our web page www.trend.community (scroll to the bottom and request an invitation).
At the end of the week we will post a blog about the data that we collect and summarize your answers in an infographic. Participation will be anonymous and only summary data will be shared. TREND Community output cannot be linked back to individual participants and individual experiences are never shared without permission.
As part of the implementation of PDUFA VI and 21st Century Cures, the FDA is continuing to develop guidance to enable more widespread usage of patient experience data to inform regulatory decision-making and is trying to best address the questions of defining it and what methods to collect it that will be most acceptable for benefit-risk assessments.
What is Patient Experience Data?
Data that are collected by any persons and are intended to provide information about patients’ experiences with a disease or condition. It includes the experiences, perspectives, needs and priorities of patients related to (but not limited to):
– Symptoms of their condition and its natural history
– Impact of the conditions on their functioning and quality of life
– Experience with treatments
– Input on which outcomes are important to them
– Patient preferences for outcomes and treatments
– Relative importance of any issue as defined by patients
(Source: Title III, Section 3002(c) of the 21st Century Cures Act)
Who can collect this data?
Any persons including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers
How to Collect This data?
Gathering patient experience data is about understanding a human perspective, and therefore uses data collection techniques from the social sciences, not the bio-chemical and medical techniques that pharmaceutical researchers have been using. Thus, the emerging guidance discusses ways to do good research in the social sciences. The main methods discussed are surveys/questionnaires, interviews and focus groups. These are good methods for eliciting people’s opinions and experiences, although there are others such as observation or analysis of conversations on social media.
TREND Community uses natural language processing and the machine learning techniques that accompany it on social media conversations to effectively and efficiently gather patient perspective and experience data to listen to what patients and caregivers are saying in their everyday lives. This novel technique has captured the interest of the FDA. We have had and are continuing to have conversations with the FDA regularly to hopefully clear the way for social media analysis techniques to be acceptable to help support better data collection and get the true patient voice heard.
Slides from FDA Workshop on Draft Guidance for Patient Experience data
Statement from FDA Commissioner 3/30/18
Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments
A call to the rare disease community: Don't stop sharing your experiences! Reconsider WHERE you share them.
Maria Picone, Founder/CEO
In light of recent reports concerning privacy violations of millions of users’ Facebook data, patients and caregivers are telling us that they are nervous to discuss private matters on social media. As the mother of a child with a rare disease, I fully understand your concerns. However, we implore you: Do not stop! Reconsider where you are posting and find private spaces for private matters.
Why? When patients and caregivers share their experiences about their disease, its progression, possible treatments and under-recognized symptoms amongst themselves they are creating rich data that companies like TREND Community can analyze to accelerate the discovery of promising treatments and bring them to market faster.
How does TREND protect my privacy?
How does TREND Community secure my data?
TREND Community secures your data with state-of-the-art, private cloud services. Our security practices comply with all current HIPAA guidelines. Our internet security measures are continually updated and monitored in order to keep private information protected and safe. We use a world-class cloud-computing provider which has signed a HIPAA compliance agreement and earned SAS Type II certification. We take several technical and procedural measures to secure electronic personal health information (ePHI) transacted through the TREND Community platform.
Why should my community move its discussions to TREND?
How can my conversations help research?
Using computer algorithms, TREND performs an analysis of patient and caregiver discussions on social media to gain valuable insights into community perspectives on living with rare disease and a better understanding of the natural history of the disease. Our technology can quickly analyze vast amounts of data from years of discussions and identify important trends. These data can be used to generate hypotheses, sparking research interest in previously under-served patient communities.
Does TREND Community sell my data?
Yes, selling de-identified community experience data is part of our business model. We foster collaborations between our rare disease communities and the companies/organizations whose products and services are focused on helping them. As part of these efforts, we may sell summary data about your community to our partners to help them better understand your disease, perspectives and priorities (for example, risks and benefits) so that they may develop or repurpose products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.
Are there any risks to sharing my data?
We ask that our participants use discretion when conversing with others online. When sharing information about your diagnosis or health, there is always a risk that someone could use this information against you. Despite the risks, we hope that you will choose to participate in these important conversations because we believe that the more health information you share, the more we can advance science and improve your life and the lives of patients and caregivers living with your disease.
Founded by parents of a child with a rare disease, the mission of TREND Community is:
To accelerate the search for treatments, interventions and cures while improving the quality of life for individuals living with rare disease.
Follow us on social media @trendcommunity!
Press Release: TREND Community is proud to announce our new Advisory Board Members, Wendy White and E. Robert Wassman, both accomplished experts in the rare disease field.
Wendy White is an innovative leader working for over 20 years in Rare Disease at the intersection of advocacy, technology and business. She currently works as a consultant to biopharma companies developing patient centered strategy and innovation commercialization plans. Prior to that, she founded, grew and transitioned Siren Interactive Corporation to Dohmen Life Science Services as part of a long-term vision to integrate patient-level insights into the drug delivery continuum. She is the mother of a child with a rare disorder and publisher and co-author of Uncommon Challenges; Shared Journeys—Stories of Love, Hope, and Community by Rare Disease Caregivers.
E. ROBERT WASSMAN, M.D.
Dr. Wassman has pioneered the introduction of genetic testing and personalized medicine for over 30-years. His focus has been on the translation and delivery of cutting-edge diagnostic technology to clinical service in the areas of reproductive medicine, rare cell/non-invasive diagnostics, and Next Generation DNA sequencing spanning clinical disciplines of reproductive genetics, cancer and companion diagnostics, and neurodevelopmental disabilities including autism. He has served as Chief Medical Officer for multiple companies in this space including Genzyme Genetics and Lineagen. He has co-founded several successful ventures.
TREND Community is a digital health company with a mission to accelerate the search for treatments, interventions and cures while improving the quality of life for individuals living with rare disease.
Contact: email@example.com for more information.