Notes from the PCOR Field: Is it Still Patient-Centered When We Say Human Subjects?

As we’ve engaged in research partnerships over the past few years, our team has learned many lessons along the way. We’ve launched this new blog series, Notes from the PCOR Field, that focuses on how partnerships with patients, caregivers, family members, and other stakeholders have changed the way we think about and conduct research. Our second post is from Patient Advisory Network Director Danielle Lavallee on the use of the term “human subjects” to describe people who participate in research studies.

Words matter. This is one of many lessons I have learned through patient-centered outcomes research. The common challenge faced is the jargon used in research. The terms used by researchers are often technical and not self-descriptive. Acronyms, ever abundant, are even worse. On occasion, however, a term or phrase comes up that, in the spirit of patient-centricity, borders on offensive. For me, that term is human subject.

In research, a human subject is defined as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information about whom includes a subject’s opinion on a given topic.” (source: US Department of Health and Human Services) Interestingly, it is most often referenced in the context of informed consent for research participation.

I find the term subject falls short as we push towards patient-centered research. As defined, the term “subject” indicates “a person or thing that is being discussed or described; a person or thing that is being dealt with in a particular way.” Placing person and thing in the same context, in my opinion, dehumanizes the person participating in the research process. It is a stark contrast to the true partnership that we strive for in patient-centered research.

The premise of patient-centered outcomes research (PCOR) is to “help people and their care partners communicate and make informed health care decisions, allowing their voices to be heard and valued in assessing the relevant health care options. PCOR promotes partnership with patients and caregivers throughout the research process to ensure that what researchers seek to study is important and informative to people grappling with often difficult and complex decisions about health.” (source: Patient-Centered Outcomes Research Institute)

It is contrary to the mission of PCOR then to view the focus of our research as merely a subject or thing rather than as a person with interests, preferences, and needs in healthcare. Humanizing our definition of who participates in research is critical. In doing so, we shift focus from what we think is interesting to research to what is important to improve patient care; we think not only about what we can measure, but what is meaningful to measure; we strive for transparency in our work; and we seek effective mechanisms to disseminate our findings to transform patient care.

But most importantly, we recognize that research is only possible with the participation of each individual who contributes time, data, experience, tissue, blood, etc., to help us all learn and advance healthcare.

At CERTAIN, we’re working to change our terminology. The term we use for people who agree to participate in our research studies is study participant – a simple but important change. Although perhaps not a perfect term, we vastly prefer it to research or study subject, as the term study participant acknowledges the willingness to contribute and gives people more agency than referring to them merely as subjects.

What do you think about the term human subjects? What other research terms do you feel need updating? We would love to hear from you in the comments below!

Do you have a lesson you’ve learned, a challenge you’ve overcome, or simply thoughts on PCOR partnerships you would like to share for a future Notes from the PCOR Field post? We would love to feature you! Contact Sarah Lawrence to discuss further.

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Welcoming 2018 at the CERTAIN Patient Advisory Network

Screenshot of INSPIRE Research Portal homepage
INSPIRE Research Portal

Wow! A blink and already it is a New Year! 2017 was another busy year for the CERTAIN Patient Advisory Network. In May, we launched INSPIREResearch.org. This web portal, developed as part of our PCORI funded project, provides access to publically available resources and tools that support patient-researcher collaborations. Over 1,000 people have visited the site since May – we are excited to see it gain traction and grow among the community!

In June, we joined forces with the University of Washington Institute for Translational Health Sciences (ITHS), one of 60 Clinical and Translational Science Award sites funded by the NIH. The ITHS promotes the translation of scientific discovery to practice by fostering innovative and community engaged research. This collaboration will allow the CERTAIN Patient Advisory Network to support regional efforts to build patient-researcher partnerships through training and networking.

Finally, we announced our first recipient of the Mary’s Fund Award, Patient Advisor Brian Do this past October. The funds will support Brian’s work on the mPOWEr project. We look forward to following his progress and work in 2018!

We are excited to kick-off 2018 with a CERTAIN Patient Advisor Network Steering Committee meeting to shape our plans for the year ahead. This includes continued work on our PCORI project focused on evidence gaps for incorporating patient-generated health data (think mHealth) into health care delivery. In addition, you will start hearing more about a new project, “The Endometrial Cancer Action Network for African-Americans (ECANA)” led by Dr. Kemi Doll. Kemi is committed to improving the healthcare black women receive. She is building partnerships with amazing organizations including Cierra Sisters; Color of Teal, Inc.; and the Society of Gynecologic Oncology to create a sustainable platform and framework for patient-centered outcomes research responsive to the needs of African-American women. I am inspired by this work – ensuring all voices are represented in research is critical, and efforts such as this will pave the way.

So much to be excited for in 2018!

Sincerely,
Danielle Lavallee
Danielle Lavallee
Director, CERTAIN Patient Advisory Network

Mary’s Fund Inaugural Award Recipient: Brian Do

Mary’s Fund was established to honor the memory of founding CERTAIN Patient Advisory Network Patient Partner Mary Roberts Scott, who passed away unexpectedly in July 2016. Mary was a strong proponent of patient involvement in research and healthcare delivery. She strengthened our work and taught us so much through her partnership and friendship. To honor Mary, a memorial fund was established within the Patient Advisory Network’s administrative home in the Department of Surgery at University of Washington. The goal of Mary’s Fund is to provide financial support for patient partnership in research. This year, we offered one award of $500 that would go to support patient involvement in research, which could include funds to support travel, training, or time spent working on research activities.

Brian Do, 2017 Mary’s Fund Award Recipient

The Patient Advisory Network Steering Committee received and reviewed 4 applications for the 2017 Mary’s Fund award. We are happy to announce that Brian Do, Patient Partner to the University of Washington mPOWEr initiative was selected as the first Mary’s Fund award recipient! mPOWEr is a mobile app for tracking symptoms of infection before and after surgery by allowing for easy and secure communication between the patient and the surgical team to minimize hospitalizations for infection and increase infection surveillance. Brian began working with the mPOWEr team nearly 2 years ago, after he was approached by an mPOWEr team member while recovering in the hospital from his own surgery. He used an early version of the mPOWEr app and saw an immediate connection in the work of mPOWEr to his own interests as an undergraduate student at the University of Washington studying human-centered design and engineering. Over the past 2 years, Brian has taken an active role on the mPOWEr team, ensuring the app’s design and evolution remains patient-centered and helping the team to evaluate how patients are using mPOWEr and where the app can be improved.

With the award from Mary’s Fund, Brian will be focusing on linking and reorganzing patient education materials that are made available to patients at different clinical sites using mPOWEr. Patient education materials are very important to improving patient understanding of how to use the app as well as how to prepare for their surgery and care for their surgical incisions after surgery to avoid infection. Of this work, Brian says he is excited about the opportunity to work on a real-world project that lets him see human centered design engineering principles that he is studying in the classroom every come to life.

Also as part of his award funding, Brian will be starting a regular blog series, focused on his experience as a patient partner and what he’s learned along the way. We’ll be hosting this blog on the Patient Advisory Network blog, so stay tuned! We’ll include Brian’s post in our Patient Advisory Network newsletters as well.

Research Update: Does Trustworthiness Matter?

In the March 2017 edition of the Patient Advisory Network newsletter, we told you about University of Washington PhD student Kate McGlone West’s research that is exploring what it means for a researcher to be trustworthy toward their community research partners and how researchers’ institutions can remove constraints on researchers that hinder their trustworthiness. A number of you participated, and we asked Kate to give us an update on her work.

In her initial survey, Kate found that 4 of the personal characteristics that she predicted to be important based on her previous work emerged as highly related to community partners perceiving researchers as trustworthy. Those areas were ethical, caring, respectful, and self-aware/vulnerable. Two additional characteristics came out of the survey data as well – putting the community first and being open to the community. Additionally, although the sample size for this first survey was too small to confirm association, it seems that those who live in urban areas tend to put more trust in researchers than those in rural areas. Other characteristics of community partners, such as age, race, gender didn’t show any effect on community partners finding researchers to be trustworthy. The community partners and researchers being the same race also didn’t have any effect on perceived trustworthiness. However, more research is needed to see if these community partner characteristics truly have no effect on perceived trustworthiness.

Kate is working on refining her survey based on these initial findings and will be launching a second round soon. If you are interested in providing input in the second round, reach out to Kate McGlone West at westkate@uw.edu.

Research Participation Opportunity: Improving Cancer Care for Black Women

Kemi Doll

University of Washington researcher Kemi Doll is starting a new research study focusing on improving healthcare for black women diagnosed with uterine cancer. Kemi and her team are looking to interview African American women who have been diagnosed with cancer in the lining of the uterus (also called endometrial cancer) about their experience with their cancer symptoms, diagnosis, and healthcare.

Any Black/African American woman over the age of 18 with a current or previous diagnosis of uterine cancer (also known as endometrial cancer) is eligible to participate. If you decide to join this study, you will participate in an interview with a member of the study team for up to 1 hour. Study participants will receive a $50 gift card to thank them for their participation.

If you are interested in participating or learning more, please contact Bridgette Hempstead, the project’s Lead Community Consultant, at (206) 579-4521, or Julianna Alson, Research Coordinator, at (206) 221-6109  or jalson@uw.edu.

Projects Seeking Patient Partners: Patient-Centered Research for Standards of Outcomes in Diagnostic Tests (PROD) Study

A wide variety of tests are used in healthcare, and often give important information to help patients and their healthcare providers make decisions about their care. The PROD study is a project based at the University of Washington that aims to improve our ability to assess both the good, as well as the possibly harmful effects of diagnostic tests. We want to create new guidelines by understanding the outcomes (such as emotional or physical demands) of diagnostic tests that are most important to patients. New guidelines will help health care providers, researchers, and people who produce tests know what information they need to gather or share in order to give patients a better say in their healthcare. Our research is focusing on diagnostic imaging tests. These include common tests like X-rays, ultrasound, CT scans, and MRI scans.
The PROD study is looking for patients who have had at least one diagnostic imaging test, such as an MRI, CT (Cat) scan, Ultrasound, or X-ray. This test could have been done to screen for a disease, or to help make a diagnosis, but preferably requested or organized by your primary care physician. Patients who share their experience as an advisor to the study can help PROD researchers make our research better. The patient stakeholder can help by telling researchers what is important for them to consider when we are interviewing other patients in this study or when the researchers are trying to understand the information they have collected. PROD researchers also want to know how to share this information with patients in the future.

Interested in learning more? Contact us!

CERTAIN Patient Advisors Represent at CUE Summit

This is the excerpt for your very first post.

By Janice Tufte, Yanling Yu, and Mahshid Lotfi

The Consumers United for Evidence-Based Healthcare (CUE) Summit was held at the New York Academy of Medicine, on March 19, 2017. Three of us from the CERTAIN Patient Advisory Network were honored to have had the opportunity to attend this year. Yanling Yu, representing Washington Advocates for Patient Safety, Janice Tufte from Muslims for Evidence Based Healthcare, and Mahshid Lotfi, a Patient Advisor with CERTAIN at the University of Washington, were all actively engaged during the summit, inquiring minds asking pertinent questions to the speakers addressing our concerns.

The main goal of CUE is to strengthen the voice of consumers and provide leadership in healthcare research implementation through guideline development, advisory groups, conferences, and panels. Its mission is to promote the health of populations and the quality of individual health care by empowering consumers, public health policy makers, and health care providers to make informed decisions based on the best current evidence through research, education, and advocacy. The 2017 CUE Summit’s theme was “Leveraging the Power of Patient & Consumer Advocacy to Transform Healthcare.” The Summit was sponsored by Agency for Health Care Research and Quality AHRQ and Patient Centered Outcomes Research Institute PCORI.

There were a number of exceptional speakers on panels and in keynote sessions throughout the day. Below is a brief summary of 3 keynotes that particularly resonated with our group:

The Politics of Consumer Advocacy: the Promise and Pitfalls of Disease Constituencies
Speaker: Vinay Prasad, Oregon Health & Science University

In his talk, Dr. Prasad argued that the voice of patients should be the foremost consideration in medical research and care. This he explained, need proper patient representation to allow for a range of voices, a cross-section of all those affected, voices which will reach some commonality or consensus, and perspective that speaks always and only on behalf of patients. Currently however, the system that represents patients does not consistently achieve all these aims. Key patient groups are missing from the conversation – patients who have died or experienced serious adverse events during clinical trials, those in rural or hard-to-reach areas, and those who don’t typically participate in research in the first place. The speaker emphasized the importance of always guarding patients’ interests, and provided the statistics that around 36% of 104 patients advocacy organizations reported to have at least one drug, device or biotechnology company executive on their governing boards, a situation that may not prove to be in the full interest of patients.

How PCORI “Priority Populations” are Engaging in Research Implementation
Speaker: Sanford Jeames, Huston-Tillotson University

PCORI was established, in part, to assist patients, providers, purchasers, and policy makers in making informed health decisions by advancing the quality and relevance of evidence and disseminating research findings. PCORI aims to assist patients, clinicians, purchasers and policy makers to make informed health decisions through advancing the quality and relevance of evidence, and to disseminate research findings in respect to health outcomes and effectiveness and appropriateness of medical treatments.  PCORI began funding research in 2012 (created in the Affordable Care Act in 2010), to ensure patient-centered outcomes research and comparative effectiveness research. . Since then, PCORI has engaged priority populations on advisory boards, and in workshops, webinars, and other formats to share their views. PCORI will continue gauging the effects of patient and other stakeholder engagement in all points of the research process and look for innovative ways to improve research outcomes through engagement.

If It Works in the UK Will It Work in the US?
Speaker: Sally Crowe, Crowe Associates Ltd

Ms. Crowe gave an overview of the continuum of engagement, which she described in 5 levels:

Level 1: here is what we are doing (informing)
Level 2: what do you think about what we are doing? (consulting)
Level 3: please get involved in what we are doing, and we still support you (engaging)
Level 4: what do you think we should be doing? OK let’s do it together, and we will support you (involving)
Level 5: you do what is important and needed, and we will support you (empowering)

To support patients and the public, one needs to consider training and development, practical support and payment, peer support and networking and may be even emotional and psychological support.  Drawing on lessons learned in the UK, Ms. Crowe offered pearls of wisdom:

  • Work with a diversity of people
  • Honor people’s priorities
  • Check your power as a researcher
  • Incorporate evaluation
  • Invest in building relationships
  • Work in partnership with clear roles and mutual respect
  • Adopt principles and values that underpin your work
  • Acknowledge and manage the policies and the power that play a part in decision making
  • Never lose sight of the purpose
  • Resist certainty
  • Stay in the difficult places
  • Listen to and work with those you disagree with

In answering the question, “are things changing?” the speaker was affirmative, pointing out several changes in the way we think and talk about engagement, an important one being changing the mindset from centrally controlled to citizen-driven.

In addition to these and other keynotes, there were many panel sessions on several critical issues. Every speaker of the day emphasized that improving performance in any field depends on sharing a common goal and cautioned everyone of conflicting goals of stakeholders that may lead to divergent approaches, thereby slowing progress.

Our Seattle-based CERTAIN Patient Advocacy Network contingency were riveted with interest during all of the presentations, where we often had more questions than we hoped could be answered. The subjects raised by a number of speakers at the CUE summit brought to our attention and kept us talking amongst ourselves throughout the day.

If you represent a consumer advocacy organization and are interested in being engaged with evidence-based healthcare opportunities, please visit this page: http://consumersunited.org/opportunities-for-consumer-engagement

Special Thanks to Reva Datar who organized the CUE summit and is our go-to person with our consumer questions year around.  Thanks also goes to CUE for supporting our travels to the summit.