UNYTE Scientific Session Explores Innovative Methods for Translational Population Health Research

UNYTE, the CTSI-organized group of 18 regional biomedical research institutions, presented its latest “Scientific Session” on December 3rd. Entitled “Transforming Population Health Research: Advances, New Methods, and Community Partnerships”, the session brought together investigators from institutions across Upstate New York to share innovative methods, develop new collaborations and promote population-health research programs.  The topic ties together UNYTE’s mission of promoting translational research through cross-institutional research collaboration, and the CTSI’s increased emphasis on improving population health.UNYTE_black_v

Dr. Kevin Fiscella, recent appointee to a Dean’s Professorship, was the keynote speaker.  His talk, “Population Health Matters:  It’s About Lives, It’s About Time, It’s About Action” presented a comprehensive vision for population health. He challenged researchers to work across the translational research spectrum and through community partnerships – taking advantage of progress toward a learning healthcare system, advances in the availability of real-time data, and patient input – to improve clinical interventions, preventive care, behavioral health, socioeconomic factors and social cohesion.  Dr. Harriet Kitzman reviewed her highly successful Nurse Family Partnership program, a nationally and internationally successful model for moving from research to implementation of highly effective population-health programs and policies. Wade Norwood, a leader in the Rochester community and the Chief Strategy Officer at the Finger Lakes Health Systems Agency, demonstrated that community-identified needs and community input in all phases of the research life cycle can be the engine that drives health improvement. Kimberly O’Brien, Professor from The Division of Nutritional Sciences (DNS) at Cornell University, reviewed her department’s innovative programs and institutional infrastructure for building the bridges between population health and basic science.

The UNYTE Scientific Session distinguishes itself from a scientific symposium by providing dedicated time on the day’s agenda for informal “meetings of the minds” and cross-institutional discussions. Small group break-outs included targeted topics on community and patient engagement, novel data collection methods for research, patient-centered care and the learning healthcare system, promoting population health across the urban-rural continuum, and an extended conversation on the necessary meeting points between basic science and population health. Awards for the poster session were given:  Dr. Deirdre Schlehofer, Assistant Professor at the National Technical Institute for the Deaf at the Rochester Institute of Technology and her research team won the Faculty Poster Award for their poster “Health Perceptions of Deaf and Hard-of-Hearing Female College Students;” Sheila Bruce, BS,  Post-BA Fellow/ Research Coordinator at the Deaf Health Communication and Quality of Life Center at The Rochester Institute of Technology won the Student/Trainee Poster Award for her poster “Population Health Research with Deaf/HH Adults in USA.”

Details for the next UNYTE Scientific Session, including the topic focus, will be announced soon. If you would like to learn more about UNYTE, please visit their website, http://www.urmc.rochester.edu/ctsi/unyte/.

Symposium Recap: Consent Comprehension

I would not have read the form, because I did not read any of the forms, because the forms are for lawyers, not for parents. I had not slept in days. I was scared out of my mind. I had the mental capacity of a drunk being chased by bears. What kind of form can protect a parent in a situation like that?

-Kelley Benham, Tampa Bay Times.  October 18, 2013.

Dr. Carl D’Angio likes to share this passage because, well, the image of a drunk being chased by bears is so evocative.

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Dr. Carl D’Angio

But he also shares it because the excerpt, written by a newspaper reporter whose daughter was born after just 23 weeks of gestation – barely halfway through pregnancy – highlights the often-colossal challenge faced by doctors and researchers looking to provide patients with an informed consent form that they will actually comprehend.

D’Angio, the host and first local presenter at the 2014 CTSI Symposium, shared a selection of research on the topic of informed consent.  A neonatologist at UR Medicine’s Golisano Children’s Hospital, D’Angio included some of his own research, and showed that when it comes to providing truly informed consent, there are rarely any easy answers.

Contrasting findings

Prior to discussing his own findings, D’Angio touched on several seemingly conflicting studies that had been done in the past.

A commonly used approach to informed consent is to decrease the reading level of the forms as much as possible in the hopes of increasing understanding.  But some studies have shown that decreasing the reading level isn’t always helpful, said D’Angio.

Lots of white space is good — consent forms should have about a third of the page be white space, said D’Angio.  But an attractive form has its limits, as visual aids are sometimes helpful in increasing understanding, but not always.

Shorter consent forms have also been tested, including a study from the Journal of Pediatrics in 1998, which compared two consent forms.  There was the traditional form, which was opt-in, and a shorter, modified consent form, which was opt-out; the modified form scored better when it came to understanding level.  But a study published in 2007 in the same journal surveyed a group of parents of oncology patients about the informed consent process, and showed that a shorter form wasn’t always what they wanted.

“They wanted clearer information,” said D’Angio.  “But many parents wanted more information rather than less.  We know shorter forms may not always be practical, but they also may not always be preferred.”

D’Angio’s own studies have also generated inconclusive results when attempting to measure the benefits of a shorter form.  In a randomized single-blind controlled study, his team tested the effectiveness of adding a simplified cover sheet to an informed consent form.  The idea was to offer a short, easy-to-read summary of the study up front, while continuing to allow patients to read the entire form in more depth, if they wanted to learn more.  But use of a cover sheet did not impact patients’ understanding.

Human interaction

Though many studies have led to inconclusive results, one of the only consistent findings across nearly every study that D’Angio mentioned was that human interaction increased understanding levels.

“Human interaction in the consent process is invaluable,” said D’Angio.  “That came out over and over and over again.”

In a study that measured a consent form from the United Kingdom with one from the United States, both consent forms were understood more clearly when a verbal explanation was offered alongside.

And while his team’s study was inconclusive in terms of the addition of a cover sheet, D’Angio said that volunteers cited interaction, as well, as vital to their level of understanding.

“When asked about what was the most helpful part of the consent process, they said the interactions with faculty and staff were valued most highly,” he said.

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The 2014 CTSI Symposium, which took place on March 13, was titled “Ethics in Research: Consent Quandaries,” and was hosted by Dr. Carl T. D’Angio, Professor of Pediatrics and Medical Humanities & Bioethics at the School of Medicine and Dentistry.  To view the Symposium in its entirety, click here.

Symposium Recap: Consent & Other Ethical Challenges in Conducting Research with Deaf Persons

Jokingly named Nim Chimpsky, he was the world’s most famous monkey, as Columbia researchers four decades ago boldly and publicly attempted to teach the chimp how to sign.

But largely unreported were the complaints made by several deaf researchers who didn’t appreciate the way that Nim’s story was being told.

“These apes were not signing,” said Robert Pollard, PhD, director of the Deaf Wellness Center at URMC.  “They were learning sign vocabulary, but that’s very different from using American Sign Language, which is often what was being reported in the media.”

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Robert Pollard

Communication gaps can damage relationships and create distrust between researchers and the Deaf community.  They can also create ethical dilemmas that endanger the informed consent process.  Speaking at the 2014 CTSI Symposium, Pollard outlined the communication challenges that can occur when researchers are working with the Deaf community.

“Some of you may not immediately think of deaf people as a language and cultural minority group, but it’s important to understand at the outset that ASL is very much different from the English language,” said Pollard.  “That difference between ASL and English is crucial when it comes to informed consent.”

Comprehension challenges

The communication issues that can arise between hearing researchers and the Deaf community sometimes stem from subtle but important differences between ASL and English.

In ASL, as in Spanish, the noun comes before the adjective: “red car” becomes “car red.”  Verbs are often positioned at the end of a sentence, just as they are in German.  “I washed my car last week” is signed typically as “Week past, my car, I washed. ”  Like Hebrew, ASL doesn’t use specific vocabulary for state-of-being verbs, such as “is,” “am,” or “are.” Both Hebrew and ASL accomplish those linguistic functions but not through a specific vocabulary term as English does.  And unlike any spoken language, space around the signer’s body can be assigned linguistic meaning, such that certain concepts, often nouns, “remain in space” and can be incorporated into a conversation simply by pointing to or glancing at that space or forming a verb within that pre-defined space.

Conversations themselves also tend to occur in a different order among deaf people.

“Deaf people will typically prioritize the importance of sharing information quickly, clearly, and in the first portion of a conversation, and will save the small talk until last.  That’s the opposite of what hearing people tend to do,” said Pollard.  “So sometimes hearing people will think a deaf person is being awfully blunt and straightforward, and on the other hand, sometimes the deaf person will think the hearing person is obsequious and hiding information.”

When it comes to reading comprehension, the average U.S. deaf high school graduate only reads at a 4th grade level.  This isn’t due to lack of intelligence, said Pollard, but due to the difficulty of acquiring literacy, which is usually taught phonetically, when deaf children arrive at school without a solid familiarity with spoken English, as hearing children do.  In fact, the best deaf readers are those born to deaf parents who arrive at school with a solid language base in ASL.  They learn to read and write English as a second language and do so more successfully than deaf children born to non-signing hearing parents.

Reading comprehension levels vary widely, of course.  But due to average abilities, it’s unlikely that the informed consent process could employ written forms; reducing highly clinical language to a 4th grade level is often challenging or impossible.

Presentation of consent information orally (without a qualified sign language interpreter present) is also out, as lip-reading is a completely inadequate means of communication for a handful of reasons.  And even if an ASL video or live ASL interpreter is employed — as is often the case in studies involving the Deaf community — a given research participant’s sign language fluency can’t always be assumed.

“You don’t learn it unless you’re exposed to it early enough and long enough,” said Pollard.  “We therefore have this enormous curve of sign fluency in the deaf population.”

The dialogic approach

But in regards to informed consent, Pollard and others have established methods to help bridge some of the communication gaps.  Some aren’t specific to the deaf population, but apply to any “host” community where research is taking place.  For example, researchers should engage the population ahead of time, and they should make concerted efforts to work with deaf researchers who may already be providing services or studying aspects of the population.  Both of these approaches can help with the informed consent process.

More specific to the Deaf community, however, is a developing method called the dialogic approach, which is based on the belief that deaf people can learn more quickly through conversation than through a more static approach.

“If you go to a meeting at a Deaf club, and there’s a lecture on something, it’s never a monologue,” said Pollard.  “It’s this vibrant dialogue.  People from the audience are asking questions.  It’s very different than my experience as a hearing lecturer.”

So rather than a video which shows just one person signing a potentially lengthy explanation of a study, researchers at the National Center for Deaf Health Research have developed informed consent films that show several deaf people having a conversation about the study.

Similar videos have come out of the Deaf Wellness Center, and the conversations always make sure to highlight all of the most important points in the “source” document. These dialogic videos can create higher levels of comprehension that a single interpreter or monologic ASL video could provide, and show that when it comes to the Deaf community, sometimes a nontraditional approach is all that’s required.

“There’s hardly any need to address the Deaf community as a disability group or a medical group,” said Pollard.  “What we’re really talking about is a different language and cultural group.”

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The 2014 CTSI Symposium, which took place on March 13, was titled “Ethics in Research: Consent Quandaries,” and was hosted by Dr. Carl T. D’Angio, Professor of Pediatrics and Medical Humanities & Bioethics at the School of Medicine and Dentistry.  To view the Symposium in its entirety, click here.

Symposium Recap: Informed Consent Quandaries and New Approaches

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Nicholas H. Steneck.

Does a doctor need consent before testing an experimental drug on you?  Accessing your medical records for a health study?  Using excess blood collected during your routine health check for a genetic study?

The answer to all of these questions is no — as long as certain requirements are fulfilled.

“The key issue is identification,” said Nicholas H. Steneck, PhD, director of the research ethics and integrity program of the Michigan Institute for Clinical and Health Research at the University of Michigan.  “So as long as I don’t know who you are, I can use your blood.  And under the right circumstances — if you’re not conscious, and the drug is something that might help you in an emergency setting — I can test that on you.”

But the process of patient consent can bring up a handful of ethical quandaries for patients and physicians alike.  The keynote speaker at the 2014 CTSI Symposium, Steneck provided a brief history of the consent process, and discussed some potentially tricky consent situations that researchers can encounter.

“Current consent systems have serious weaknesses — I don’t think I’m telling anybody anything that they don’t know at this point,” said Steneck.  “It’s an area where there’s lots of interesting work to be done and lots of challenges.”

Quandaries

Informed consent was written into law after many controversial studies came to light in the early-to-mid 20th Century.  Fallout from the studies was so explosive that some have become ingrained in popular culture — an Emmy-award-winning HBO movie was made about the Tuskegee syphilis experiments, while a 1989 Billy Joel single references the “children of thalidomide.”

Though the Common Rule was put in to place in 1981, Steneck also touched on several more contemporary examples, including that of a Columbia University professor who in 2001 attempted to measure customer service responses by sending phony letters to hundreds of New York City restaurants alleging food poisoning.

“Can you imagine what happens if you send a letter to a five-star restaurant in New York City saying you got food poisoning?” said Steneck.  “Columbia University was flooded with ‘We’re going to sue you,’ once they found out.  Never a clue on the part of this researcher that he had to get informed consent on that.”

But most breaches aren’t quite so egregious.  Many stem from well-meaning attempts to provide information that isn’t properly understood by subjects.  Consent forms that use overly complicated language are a common culprit.

“How can you turn out a 20-page form written in 12th grade language and say with a straight face ‘We are providing informed consent to our subjects,’” said Steneck.  “It’s a quandary because there are reasons why those forms are that long.  There are reasons you have to include that much information.  What do we do about that?”

Possible approaches

The simplest fix is to improve an informed consent form’s readability.  Creating a consent form that is encompassing yet readable can be a challenge, but using simpler language — less challenging vocabulary words and shorter sentences — can measurably improve understanding.

Steneck showed one consent form that began with a checklist which covered all of the necessary elements.  At the top, it covered the IRB approval, and followed that with the elements of consent, HIPAA notices, options, and record.  Each section was clearly laid out, and every element fit on one page.

Accompanying the one-page consent form in Steneck’s example was an information pamphlet explaining the study, and showing a visual representation of a BioLibrary, which likened it to a traditional library.

A study conducted by Steneck’s team showed that separating these two steps can create a high level of understanding — 89 percent of participants scored perfectly when asked about their level of comprehension.

“The idea here is we do the informing process separate from the consenting process,” said Steneck.  “But it’s a change.  The process of moving the understanding outside the consent form, I understand is a risky one.  It’s a risky one for the people who are responsible for assuring that we’re following the Common Rule.”

Under current conditions, this type of separation isn’t ideal.  A participant could potentially file a lawsuit and claim that they never received the informational pamphlet.

It’s here where an electronic consent form could potentially bridge the gap, but that can create other obstacles, such as added costs, privacy concerns and logistical issues such as the need to sterilize an iPad every time a new participant uses it.

Regardless, the informed consent process needs to be improved, said Steneck.

“As in all areas, researchers need to get on top of this, administrators need to get on top of this, before somebody else gets on top of it and tells us what we have to do,” he said.

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The 2014 CTSI Symposium, which took place on March 13, was titled “Ethics in Research: Consent Quandaries,” and was hosted by Dr. Carl T. D’Angio, Professor of Pediatrics and Medical Humanities & Bioethics at the School of Medicine and Dentistry.  To view the Symposium in its entirety, click here.

Symposium Recap: Informed Consent in Community Participatory Research

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Cindi Lewis

Not only were researchers selling the blood of study participants to Satanists, but they were using the profits to buy new vehicles, which they’d brazenly drive to follow-up visits.

At least, that was the rumor going around at some trial sites of the HIV prevention trials network, an example taken from Woodsong and Karim 2005 American Journal of Public Health publication.

“We kind of laugh at it now, but it was serious,” said Cindi Lewis, a PhD candidate in the CTSI’s Translational Biomedical Science Program. “The people really thought that ‘blood money’ was somehow involved here, and they were superstitious about it, and they were not going to participate.”

While researchers regularly spend time educating participants on the front end of their studies, informed consent can be a moving target which requires regular follow-up throughout the duration of a trial. That’s especially true when dealing with communities that may be less developed, less educated, or more vulnerable — communities wherein rumors or distrust may spread more readily among participants.

Speaking at the 2014 CTSI Symposium, Lewis outlined a continuum of strategies that researchers can employ to ensure that study participants are giving fully informed consent throughout the duration of a study, which can help prevent rumors like the one mentioned above from spreading.

“Typically, people sometimes like to think about the informed consent as a fixed point in time when you bring people in, and then the trial goes on,” said Lewis. “But it’s really a dynamic process.”

Pre-enrollment

Lewis, who has worked on several research projects centered on HIV trials, spoke about the informed consent process in three phases: pre-study enrollment, enrollment, and the continuation of the study, as based on Woodsong and Karim’s proposed framework to improve informed consent in target communities.

During the pre-enrollment process, it’s vital for researchers to observe and interact with the community that they are going to be studying. This means spending time at community gatherings, such as town hall meetings or church services.

If possible, the researcher should attempt to form a partnership with individuals or groups that are already working to provide services to their community. By doing so, a researcher can form a community advisory board that truly has its finger on the pulse of the population.

“Sometimes when we look at the composition of community advisory boards, they’re not truly representative of our population,” said Lewis. “This is where, in the beginning, selecting an adequately representative community advisory board — people who are really connected to the community and are going to hear these rumors, these things that aren’t on the surface — is very important.”

An informed community advisory board can provide valuable insight into community response as the study progresses. It can also help researchers understand what suspicions may be inherent within a community from the outset, especially as the team moves into the second phase.

Enrollment

Though researchers need to be careful about satisfying the requirements set by the federal government and internal review boards, a creative approach to the informed consent process can help.

Lewis highlighted an example from the Carraguard Microbicide trial held in South Africa in which the research team created an image of a study participant that they named “Serena.” In early mockups, she was wearing a bandana, but as they moved through the pre-enrollment phase and learned more about their community, Serena evolved into a woman with long, curly hair. The image was meant to depict a community member and to make potential participants feel more at ease with the notion of joining the study.

Additionally, one piece of study documentation featured a visual representation of the concept of randomization, which featured a mixed group of people with pair of dice in the foreground. This helped to get the concept across to a population that may have struggled with the clinical definition.

The enrollment phase is also a good time to be proactive about addressing misconceptions — which could serve to cloud the minds of participants as the study progresses and effectively negate informed consent.

In the HIV vaccine trial group led by URMC’s Dr. Michael Keefer, Lewis is working with the group to develop materials that clearly depict key vaccine messages in the hopes of improving trial participants’ understanding of the information provided to them. For example, the fact that HIV and AIDS cannot be contracted through a vaccine — a common misconception — needs to be well-emphasized.

Continuation of study

Throughout the study period, researchers need to follow-up with the community to ensure that they remember what the study is about to begin with.

“Maybe they have an understanding right at the point where they come in to the trial,” said Lewis. “But if the trial goes on for 2 years, and I ask you 6 months down the road to tell me something about this trial and you knew nothing, but you’re still enrolled in the trial, can we really say, ethically, that this person is informed?”

Proactive efforts and steady follow-ups can help keep the participants informed. They can’t, however, prevent the emergence of every piece of misinformation. In the example referenced earlier, researchers had to work quickly to dispel the notion that they were selling the collected blood to Satanists, even limiting the amount they used the vehicles that they’d supposedly purchased with the “blood money.”

But through a concerted effort — which starts in the pre-enrollment period and continues through the end of the study and beyond — researchers can get a handle on rumors like this one, helping to ensure that their study participants are truly informed.

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The 2014 CTSI Symposium, which took place on March 13, was titled “Ethics in Research: Consent Quandaries,” and was hosted by Dr. Carl T. D’Angio, Professor of Pediatrics and Medical Humanities & Bioethics at the School of Medicine and Dentistry.  To view the Symposium in its entirety, click here.