CTSI Seminar Series: CTSI Year Out Trainee Presentations Part II

presentations1-241x262The CTSI Seminar Series for Spring 2014 continues on Tuesday, April 22nd with a presentation by two CTSI Year Out Trainees. The CTSI supports medical students interested in a year-out experience of mentored research in clinical or translational research. The following two trainees will be presenting their research:

Aimee Morris – “Clinical Characteristics, Musical Variables, and Pathophysiology of Focal Embouchure Dystonia: A Disabling Disorder of Musicians”

Jeffrey Reed - “The Effects of Erythropoietin on Healthy Bone

The learn more about the CTSI Year Out program, click here.

The theme of the Spring 2014 series is “Crossing Elmwood: River Campus-Medical Center Research Collaborations” and will showcase ongoing research collaborations between the University research community and the Medical Center. The series also aims to stimulate new research teams and areas of investigation capitalizing on the existing strength of faculty and programs. The Organizing Committee for the series includes Robert Holloway, MD, MPH, Peter Lennie, PhD, Rob Clark, PhD, Stephen Dewhurst, PhD, Karl Kieburtz, MD, MPH, David Williams, PhD, Richard Waugh, PhD,  and Joanna Olmsted, PhD.

The series takes place on Tuesdays from 12:15-1:15 pm in the Helen Wood Hall Auditorium. You can access the full schedule here. Lunch is provided. Please provide your own beverage. The University of Rochester School of Medicine and Dentistry designates this live educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)TM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Public Health Grand Rounds: Data shows disparities not always attributable to race

There are those who are quick to assert that African Americans are more likely to be overweight; that Hispanics are more likely to struggle with mental health issues.  And when the data, on the surface, appears to match the stereotype, confirmation bias can make it an easy story to perpetuate.

AnnDozier

Ann Dozier

But information collected in Monroe County over the past 17 years shows that researchers need to closely examine myriad contributing factors before declaring that race or ethnicity leads to an increased risk for certain behaviors or health conditions.

“We talk about racial disparities, but maybe there’s a lot more going on underneath that we need to be attentive to, rather than just labeling a difference due to race,” said Ann Dozier, RN, PhD, Associate Professor in Public Health Sciences.

Starting in 1997 and continuing in 2000, 2006, and 2012, the Monroe County Health Department began surveying a random sample of adults in Monroe County, and a deep dig into the results shows that over time a handful of factors are more strongly correlated than race or ethnicity when it comes to certain behaviors and health conditions.

Dozier, who spoke about the findings at a March seminar in Helen Wood Hall Auditorium, compared data from five of the categories: smoking, perceived health, mental health, obesity and overweight, and insurance coverage.

In addition to race or ethnicity, the data were adjusted for age, gender, education level, and whether the person was a city or suburban resident.  Once controlling for these other conditions, race and ethnicity became almost a complete non-factor.

Smoking

  • Raw data showed that, at various points from 1997 and 2012, both African Americans and Hispanics were significantly more likely to be smokers than whites.
  • However, after adjusting for the four factors listed above, Black race and Hispanic ethnicity were not shown to be indicator for whether a person was a smoker in the 2006 and 2012 studies.  (In 1997 and 2000, adjusted data showed that African Americans were actually less likely to be smokers than whites.)
  • Instead, significant indicators were age, education, and place of residence.  Those below the age of 65, those with less education, and city-dwellers were all significantly more likely to be smokers.

Perceived health

  • Again, raw data showed that both African Americans and Hispanics, at various times between 1997 and 2012, were more likely to self-report their health as “fair” or “poor” than whites were.
  • But after adjusting for the four factors, no significant difference between self-reported perceived health was shown between Whites and African Americans in 2006 and 2012.   African Americans did report worse perceived health at significant levels in 1997 and 2000.
  • Age, education, and place of residence were again seen as significant indicators.  Those above the age of 65, those with less education, and city-dwellers were all significantly more likely to report a lower score for their perceived health.

Mental health

  • Participants were asked “Have you experienced stress, depression, or problems with emotion on 14 or more of the last 30 days?”  Raw data showed that African Americans and Hispanics, at various times between 1997 and 2012, were more likely to answer “yes.”
  • After adjusting for the four factors, Black race and Hispanic ethnicity were rarely found to be significant indicators for poorer mental health.  In 1997, Hispanics were still significantly more likely to report mental health stressors than whites, while in 2012, blacks were significantly less likely to report than whites.
  • Age and education were significant indicators for poorer mental health.  Those below the age of 65 and those with less education were more likely to report mental health stressors.

Body Mass Index

  • BMI was broken into two groups: overweight and obese.  Both raw data and adjusted data from the overweight group showed that minority groups were no more likely to be overweight than whites.
  • For obesity, adjusted data showed African Americans were more likely to be obese than whites in 1997, 2000, and 2006.  By 2012, adjusted data showed no significant correlation.
  • Significant indicators were gender for the overweight group and education for the obese group.  Men were more likely to be overweight, and those with less education were more likely to be obese.

Insurance Coverage

  • Once again, raw data showed that both African Americans and Hispanics, at various times between 1997 and 2012, were less likely to have health insurance than whites.
  • However, adjusted data showed no connection between Black race or Hispanic ethnicity and insurance coverage, except for at one point: in 2000, African Americans were less likely to have coverage.
  • Significant indicators were gender, age, and place of residence.  Men, those below the age of 65, and city-dwellers were less likely to have health insurance.

Conclusions

Dozier said that the analyses did have some weaknesses.  For one, all the data points are self-reported.

“So think about weight.  Are people being honest about how heavy they are?  That could actually be understated,” she said.

Researchers also weren’t able to adjust for other factors that might potentially contribute to these categories, such as marital status or income.

But conclusions can still be drawn from these findings.  Less education is a factor in key health behaviors.  Age is a factor in smoking, mental health reporting, and health insurance coverage.  Men are more likely to be overweight and less likely to have insurance.  And city-dwellers are more likely to smoke, and less likely to have insurance.

For each of these categories, race and ethnicity isn’t the end of the story.

“Disparities may have a component that may be attributable to race or ethnicity,” said Dozier.  “But we should be cautious about overstating what that relationship is, and we should be looking at them in the context of potential confounding factors.”

 

 

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.

CarlDAngio

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.

*

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.

CTSI Seminar Series: CTSI Year Out Trainee Presentations Part I

presentations1-241x262The CTSI Seminar Series for Spring 2014 continues on Tuesday, April 15th with a presentation by three CTSI Year Out Trainees. The CTSI supports medical students interested in a year-out experience of mentored research in clinical or translational research. The following three trainees will be presenting their research:

David Paul – “Using DTI to measure changes in occipital lobe white matter after decompression of the optic chiasm”

Jarrod Bogue – “Investigation of the fundamental biochemistry and conformational properties of a specific riboswitch from Neisseria gonorrhoeae”

Melissa Squires – “Analysis of Inpatient Data on Patients with Intellectual and Developmental Disabilities at Strong Memorial Hospital”

The learn more about the CTSI Year Out program, click here.

The theme of the Spring 2014 series is “Crossing Elmwood: River Campus-Medical Center Research Collaborations” and will showcase ongoing research collaborations between the University research community and the Medical Center. The series also aims to stimulate new research teams and areas of investigation capitalizing on the existing strength of faculty and programs. The Organizing Committee for the series includes Robert Holloway, MD, MPH, Peter Lennie, PhD, Rob Clark, PhD, Stephen Dewhurst, PhD, Karl Kieburtz, MD, MPH, David Williams, PhD, Richard Waugh, PhD,  and Joanna Olmsted, PhD.

The series takes place on Tuesdays from 12:15-1:15 pm in the Helen Wood Hall Auditorium. You can access the full schedule here. Lunch is provided. Please provide your own beverage. The University of Rochester School of Medicine and Dentistry designates this live educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)TM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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.”

RobertPollard

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.”

***

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.

Through LEAN processes, CTSI streamlines job titles

Some departments called them information analysts.

Others called them tech associates.  Or health project coordinators.  Or laboratory technicians.  Or any of nearly three dozen other titles that were unearthed when stakeholders in the CTSI and elsewhere analyzed who, exactly, was coordinating research studies of human subjects.

With at least 30 redundant job titles across the university, the myriad of positions created several logistical challenges.  Chief among them was that no one could be certain that each of the coordinators had been trained in the proper way.

NancyNeedler

Nancy Needler

“We were trying to identify the best mechanisms for reaching out to coordinators to support them, and we used to say ‘How can we make sure we’re reaching everyone we need to?’” said Nancy Needler, research subject advocate for the CTSI.  “There was no one complete method to do that.”

But using methods consistent with LEAN manufacturing, a waste-eliminating methodology developed by Toyota, the CTSI was able to connect with both leaders and front-line staffers in departments all across the university to address the issue.

The  CTSI-facilitated workgroup, collaborating with human resources (HR), established the new title of “human subject research coordinator,” separating it into a three-step track based on responsibility levels and experience.

With that, 30+ job titles have become just three.

LEAN

Streamlining the job titles will have benefits that stretch well beyond training efficiencies.  Coordinators now have defined and easily-measured career paths, which may make the positions more appealing.

They can move more easily between departments, since the nomenclature will be the same.

And most importantly, the new system will ensure that coordinators are properly trained to their appropriate levels.

Needler, who coordinated the activity to consolidate the human subject research coordinator positions, said that LEAN’s methodology and problem-solving methods helped make the initiative a success.

“We didn’t always agree.  You’re not supposed to,” said Needler.  “But you have to agree to disagree and you also have to agree to seek consensus.”

At the next SCORE meeting from noon to 1 p.m. on Thursday, April 10 in Helen Wood Hall auditorium, Jenny Argentieri, manager of LEAN education and training at the medical center will present an introduction to the LEAN approach.

Though it began in an automobile factory, the LEAN methodology applies to all manner of industry, including that of research. Because the workgroup members openly shared their input, and HR welcomed and encouraged the process, the creation of this new job series was successful.

“LEAN teaches that the only thing worse than not getting employees engaged in process improvement is asking for the input and not following through with their ideas,” said Needler.

CTSI Seminar Series: Mobile phone-based asthma self-management aid for adolescents (mASMAA): “Txt4ASMA”

textingThe CTSI Seminar Series for Spring 2014 continues on Tuesday,April 8th with a presentation by Hyekrun Rhee, PhD, RN, PNP and James Allen, PhD. Drs. Rhee and Allen will be presenting their research in a seminar entitled “Mobile phone-based asthma self-management aid for adolescents (mASMAA): Txt4ASMA.” Dr. Rhee is an Associate Professor at the School of Nursing and Dr. Allen is the John H. Dessauer Professor of Computer Science on River Campus.

Abstract: Adolescents report high asthma-related morbidity that can be prevented by adequate self-management of the disease. Therefore, there is a need for a developmentally appropriate strategy to promote effective asthma self-management. Mobile phone-based technology is portable, commonly accessible, and well received by adolescents. The purpose of this study was to develop and evaluate the feasibility and acceptability of a comprehensive mobile phone-based asthma self-management aid for adolescents (mASMAA) that was designed to facilitate symptom monitoring, treatment adherence, and adolescent–parent partnership. The system used state-of-the-art natural language-understanding technology that allowed teens to use unconstrained English in their texts, and to self-initiate interactions with the system.

Drs. Rhee and Allen published their findings in the journal “Patient Preference and Adherence.” To read the entire publication, click here.

The theme of the Spring 2014 series is “Crossing Elmwood: River Campus-Medical Center Research Collaborations” and will showcase ongoing research collaborations between the University research community and the Medical Center. The series also aims to stimulate new research teams and areas of investigation capitalizing on the existing strength of faculty and programs. The Organizing Committee for the series includes Robert Holloway, MD, MPH, Peter Lennie, PhD, Rob Clark, PhD, Stephen Dewhurst, PhD, Karl Kieburtz, MD, MPH, David Williams, PhD, Richard Waugh, PhD,  and Joanna Olmsted, PhD.

The series takes place on Tuesdays from 12:15-1:15 pm in the Helen Wood Hall Auditorium. You can access the full schedule here. Lunch is provided. Please provide your own beverage. The University of Rochester School of Medicine and Dentistry designates this live educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)TM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.