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Tanisha, thanks so much for agreeing to talk to us about the work that you do in the US for the Department of Defense. Could you tell us a little bit more about the organisation and the sort of research that it supports?

Absolutely. It’s a good place to start! There was a Congressional Mandate in 2009 to stand up the Hearing Center of Excellence (HCE). Within a few years, there were similar mandates to stand up a Center of Excellence for Traumatic Brain Injury (TBI) and Psychological Health and Vision and Extremities and Amputees, and so we’re the fourth of the four Congressional Centers of Excellence stood up. And our mandate covers the full spectrum of auditory and vestibular disorders, from prevention and mitigation, treatment, rehabilitation. And so our mission is quite broad: we’re not a research facility, nor is it a clinical facility; it’s quite a broad scope.

And across all of that, research coordination is one of the branches in the Hearing Center of Excellence which really serves as a means to improve prevention strategies for our service members and veterans, and clinical best practices and improved outcomes for service members and veterans. Our Congressional Mandate is through the Department of Defense (DoD), yet the language says that we’ll coordinate as much as is practicable with the Veterans’ Affairs department, and so our deputy chief, she’s a VA employee, so we do have a lot of focus not just on the war fighter, but the continual life cycle of the service member through their veteran status. So that also broadens our scope quite a bit, obviously.

There’s a lot of different ways that we approach research coordination in the HCE. Some of our primary focuses are just facilitating and coordinating. There’s so much going on across the DoD alone, from the bench laboratories, who are doing wonderful work in acoustic sciences and have been for many decades, all the way through clinical treatment facilities with top-tier clinicians in trauma care in really unique scenarios, and they weren’t very well connected; there was no existing platform for that sort of interaction and communication, so we serve as kind of a translational platform and guide for those collaborations and conversations to take place.

We started the Collaborative Auditory and Vestibular Research Network – CAVRN –to bring all of the research stakeholders together, from bench to bedside researchers to the funding portfolio managers, those who are actually driving the science forward, and prioritising the research lines for the future, and future combat concerns.

So part of the research coordination within the Hearing Center of Excellence is to have an overview of that pipeline and help facilitate those researchers.

Absolutely. That’s a big part of what we do, is work from the top down: we work with the portfolio coordination, the leadership in DoD, other Centers of Excellence that have maybe a polytrauma or some sort of polymorbitiy, comorbidities with us, your blast and TBI patients are prime examples of that. And then from the bottom up, the really sort of grassroots approach of reaching out into our communities. We have Sarah Murphy, who is stationed as a contractor at the Navy Medical Center, San Diego, and we have many counterparts like her throughout the system, who are integrated with the investigators, integrated with operational and public health commands and other DoD boots on the ground to siphon that information back up. So it’s really on-going bi-directional.

It seems like a really great infrastructure. So your role is research coordinator within the organisation. Can you just tell us a little bit about the kind of research that you’re currently involved in; what one project really excites you at the moment?

Sure: I can name a few, actually. Of interest, I think, to the British Tinnitus Association readership: we are engaged with the National Center for Rehabilitative Auditory Research in Portland, Oregon, the NCRAR, and a study that’s run by Dr James Henry, he’s leading a study into noise exposure in service members and following out where there’s noise and other sonic exposures common in the military environment in the act of duty, and recently separating veteran populations and how those affect and impact their lives, their quality of life, their hearing loss, their tinnitus specifically; that’s a big interest. So we’re excited to be part of that. It’s a longitudinal study, so we shall be collecting data for many years to come, funding pending, and we’re already getting really valuable and meaningful outcomes on the impacts of hearing loss and tinnitus on service member populations.

We’re also doing a study with Dr. Fatima Hussain from the Beckman Institute at the University of Illinois, who’s looking to create objective diagnostics for tinnitus through functional MRI, so we’re a participating site on her grant. Speaking to the UK, we are partnering with the Ministry of Defence (MoD) in the UK to look at standardising data collection for our Allied forces for starters, and we’re doing that not just for the UK but with many NATO partners. We’re trying to come up with some common data elements so that there are some ways to compare outcomes down the road and similarly, the HCE has a large driving mandate to develop a registry of all auditory injury in the DoD, and share that data bi-directionally with the VA, and that registry has already been discussed in the NATO context and has really driven some inspiration for similar registry builds in our partner nations.

But with the MoD in particular, we have started to advise on studies that they’re doing, to collect super-threshold measures so that we can be a bit more sensitive in our monitoring of these new noise hazard weapons, shoulder-fire weapons like the Carl Gustaf, which there have been very high-risk assessments of. So we’re doing that with the UK.

So those three studies I think are good examples of areas that we’re working on in tinnitus with the UK.

It’s really great to hear that there’s that connection and collaboration between the US and the UK on those projects. I know that as part of your role, you also coordinate a working group that’s focusing on pharmaceutical interventions for hearing loss, the PIHL group. Can you just tell us briefly what that’s all about?

Yes, right when the Hearing Center first stood up, we recognised that as a gap, it’s an important area of enquiry, and growing every year in the number of publications and presentations on that topic, and yet, over the decades, there has been a stagnation where it had not reached, back in 2011, the point of any clinical trials or FDA clearance. So it was a recognised gap where there were some areas where the HCE felt we could intervene and create a platform for communication and collaboration that could help expedite this research forward. And so we chartered the PIHL working group (Pharmaceutical Interventions for Hearing Loss).

We wanted to focus on reviewing the data for science, and we wanted to try to develop some guidance for researchers, such as best research practices. We wanted not only to develop these but make sure that we disseminate and get them implemented in research practice, so we do that through a few different approaches. One, obviously, is the PIHL working group itself, a large stakeholder roster of people from all walks of the issue, and bringing them together on one common platform has been largely successful in getting kind of a consensus guidance out in a number of areas, including clinical trial development. We had a workshop at the ARO meeting in 2016 on that topic and we have worked with the journal editors to ensure that we’re spreading these PIHL disseminations out across different journals that have different readerships, so we’re broadening our dissemination and including a broader range of interest every year.

We’re up to about 175 people: we range between 150 and 200 as they come and go, as they should in a group like that.

Do you know how many countries are represented in the PIHL group?

Right now, I think we’re at about six: the UK, France, Germany, Israel, Canada and the US. We’ve been growing internationally in the last two years, quite rapidly, and things like this ARO meeting I think really help with that, providing a nice platform to reach out globally. The stakeholder range in that group has been, I think, the biggest strength of the group: not just having bench or clinician scientists, but folks from public health and folks that will be further down that translational pipeline in the research have been engaged from the beginning in pharmacology and other things. So it’s really nice to put something together that has the potential to actually see its implementation in place and have clinical efficacy and clinical relevance in the end.

Oftentimes, we’re left out of the early stages of scientific development, I think, and I think this group has poised the field very well to move forward a lot smarter.

Just focusing down a bit more on some of the concepts in research. We know that military personnel are exposed to high levels of noise during active service; could you just try and explain in simple terms, what is the link between hearing loss and tinnitus in this population?

I wish that I could in clear terms! I can tell you that it’s something that we’re very interested in in HCE and the DoD at large; it’s something that Congress is interested in, and they mandated a study that was published by the Institute of Medicine in 2005 [1]. It’s on noise in the military, and they clearly made the link between hearing loss and noise and hearing loss and tinnitus, and they outlined several gaps in research that ought to be pursued. So those bullet points from that report are found throughout the portfolios of the DoD’s joint programme committees now, including Jim Henry’s study, which is largely following those recommendations as well.
There’s been a lot of work here at ARO, as well, from those DoD-funded programmes that I just saw this week, so that’s exciting, and some of those answers are starting to surface, but I think that’s a complicated question!

You’ve recently completed a really extensive review, a brilliant piece of work: you’ve pulled together all of the current evidence for the effect of pharmaceutical interventions for noise-induced hearing loss in animal models and in humans. Could you try to summarise for our readers what would the main insights or findings from that body of work be?

If I had the graphs to show you, you’d see that the outcomes were sort of flat across the board, meaning that there was so much disparity that nothing really stood out, and that’s what stood out. The disparity was not just prevalent but very ubiquitous, in such a way that outcomes were disparate and incomparable.

Was that in terms of methods or actual findings?

The different domains were the animal models and the use of animal model strains. Each gets disparate noise exposures, so whether it’s impulse, steady state, blast, what frequencies were used, what durations, these were all disparate. There were some studies that also added an ototoxic agent but that was not the focus of my review, so those were excluded. But nevertheless, there was a range.

The statistical analyses used were also, I would say, under-reported or not reported to standards, so quality was also really a problem. That’s definitely a big takeaway, that the quality of reporting was not up to standards, and is not something that clearly is being employed in this field throughout even some of the top journals. There was no correlation between higher-scoring journals and the quality of the papers. So that was disappointing to see, too. And there’s a lot of work our field can do to up their game in that respect.

Can you just explain to our readers in simple terms, what’s the impact of that variability? Why should we care?

One of the most important parts of scientific process is repeatability, and being able to verify results, and if you are in a scientific lab, trying to reproduce a study that you’ve read about online to see if it indeed has the same results, or can have similar results with your compound instead of the compound that was used in the published study. It’s very challenging to do that when the reporting does not include of all the relevant information that you need to repeat the study. That’s a big problem.

It’s also a very big problem when it comes to trust in the science that you’re reading, and if you cannot verify what was done, if you can’t even quite understand what was done, it’s hard to trust that the results are as robust as they may claim —or otherwise. There are so many more problems, that’s a whole different interview, but you could go into how many negative results are never published at all; there are all kinds of problems with that.

It’s an issue that’s well-recognised in the UK as well. And in fact, our government funding bodies are very focused at the moment on replicability. They’re very much in favour of pre-registering or publishing protocols to actually describe what your methodology is going to be, particularly in terms of how you’re going to analyse the data to address your question.

I did register my review. I had good mentors to tell me. I think that’s part of the problem: a lot of people aren’t told that that’s even a thing, and so they’re not aware that there is a new registry for a basic science protocol.

It sounds like there’s lots of really interesting work going on at the moment. What exciting scientific break-throughs do you think that we might see in the next ten to fifteen years, if you had a glass ball to look into the future?

Ten to fifteen years? There’s so much exciting research going on and looking at not only my own graphs and the PIHL systematic review, but what I’ve seen here at ARO this week is that numbers of publications are just exponentially sky-rocketing. So progress is being made across a number of fields: things like hidden hearing loss coming out of the woodwork in the last several years point to a lot of promising work to be done in the next ten or fifteen years about earlier detection and intervention points that could really prevent permanent thresholds shift (PTS) out of what are common temporary threshold shifts (TTS).

When it comes to new developments in pharmacological therapies, I’m very hopeful. There are clinical trials now going on into prophylactic and early rescue interventions in the metabolic pathways of TTS to PTS, but there’s also really exciting regeneration work going on that’s entering clinical trials, and so seeing where those lead in the next ten years, even, should be very exciting again.

Certainly five years ago, we never thought that we’d be at a stage of looking at regeneration.

No, even in the middle of October, I didn’t think that regeneration would make as fast strides, but some of that speaks to the motivations of the research, I think, when you look at things like prophylactic or acute rescue, you have a very finite window of when you can intervene, and the market. When you talk about the World Health Organization and 50 million people, all these large numbers that get the attention of Big Pharma, those dwindle away when you narrow it down to that acute period that for something like presbycusis, which obviously has huge implications for our veteran community, and certainly Big Pharma has interest in those large numbers, and money gets science done!

Thinking about the challenges of working in this translational space, what do you think the biggest challenges are for tinnitus research at the moment?

Awareness is, I think, a very key issue. And it sort of leads to another issue-

Do you mean awareness in the general public or the clinical community?

I think awareness in the general public leads to sustaining funding for tinnitus research; there are public drivers of science, usually, so having more of an awareness of tinnitus across the public domain I think is really important, for a couple of reasons, not just sustaining funding. If the patients are not really aware of what they have and don’t know how to qualify or categorise it, they may not even think to discuss it with providers. I know many people are in that category: so they’re not having discussions with their providers, they’re just not being collected in data for incidence and prevalence, so we don’t have the epidemiological data to support further research as well. It’s all sort of a cascading effect.

I think hyperacusis is in that same bundle, where there are disagreements about nomenclature and how you categorise different kinds of tinnitus, different kinds of hyperacusis as well, and all of those disparities in knowledge and awareness of the condition itself really do a disservice all the way down the line of research. So it’s hard to know how to develop models for certain causes that you really don’t understand the mechanisms underlying, and if you don’t know that there’s different kinds, you may not be looking for additional mechanisms.

I know tinnitus is a little further along in that than hyperacusis.

I guess the awareness gap is something that the British Tinnitus Association – and the American Tinnitus Association – are trying to plug through their outreach work and general promotional work.

Agreed, as is the HCE. We’re very dedicated to increasing awareness across our service members, our providers. We have more than the PIHL working group: we utilise that platform in multiple domains, including tinnitus, so we have a tinnitus working group that’s trying to develop and disseminate best practices, and some of that will probably include some educational components for the patients.

Quite a lot of our readers would like to know whether there’s ever going to be a cure for tinnitus. What would you say to somebody who asked you that question?

Well, I would say hold out hope. I mean, there’s progress being made, and in the midst of the on-going research and progress being made toward a cure, there are still a number of new developing and fairly evidence-based approaches for therapies. You can look into cognitive behavioural therapies like Progressive Tinnitus Management, or sound therapies that are gaining in evidence base to back their claims of providing coping mechanisms for tinnitus patients that have certainly come a long way just in the last few years. While coping is not cure, it’s certainly helpful and can improve function and quality of life, so I would say hold out hope. The further that basic research gets in understanding those underlying mechanisms and teasing out ways to understand and diagnose what is causing individual A versus individual B’s actual tinnitus, the closer we’ll get to targeting interventions for each of those different pathways.

Thank you, that’s a very positive message And finally, is there any other message that you wanted to share?

I would say get involved and there are numbers of growing ways that patients and providers can get more involved. I know in the UK, the Action on Hearing Loss group provides a sort of platform like that; the HCE strives to be that platform for service members and veterans to have a single place to come to get information to be aware of on-going research and there are a number of ways to look into that. And I think the difficulties in science are usually overcome with collaboration, and sharing lessons learned is the fastest way to increase efficacy of research and ‘work smarter not harder’ is a saying we have here. Collaboration is not always easy, and of course there are some barriers to that, but ultimately, communication, if not collaboration, is a good start. So even things like limited tinnitus research funding I think can certainly be helped and not hindered by a unified voice, and so when patients get involved and providers get involved and work with research organisations, it adds a lot of credibility and spotlights those issues. Tinnitus certainly has more room to grow in those areas, so get involved!

Thank you: that echoes very much my approach to tinnitus research. It’s been really interesting hearing what you’ve got to say, thank you very much.

References

[1] Institute of Medicine. Noise and Military Service: Implications for Hearing Loss and Tinnitus. 2006. The National Academies Press.

About Tanisha Hammill:

Dr Tanisha Hammill

Chief, Research Coordination Branch
DoD Hearing Center of Excellence


Dr. Hammill currently serves as the Research Coordination Branch Lead for the Department of Defense Hearing Center of Excellence (HCE). In this position, she oversees a global research effort to support the military’s Hearing Health Program, which includes the coordination of a regional team of administrators, portfolio coordinator and targeted project teams; various work stream group coordination efforts including the HCE’s Collaborative Auditory/Vestibular Research Network (CAVRN) and Pharmaceutical Interventions for Hearing Loss (PIHL) Working Groups, among others, comprised of hundreds of subject matter experts from around the world; research experience spanning bench to bedside to community to policy; and scientific steering and road mapping contributions to the scientific community.

She completed a Master of Arts degree in Religious Studies and Ethics from the Point Loma Nazarene University in San Diego, and a Master of Arts in Public Health with a focus in Administration from the San Diego State University. Dr. Hammill completed her PhD programme in Translational Science at the University of Texas at Austin, with affiliation at the UT Health Science Center San Antonio, UT School of Public Health and UT San Antonio, and maintains professional certifications as a Clinical Research Administrator and Project Management Professional.


“hold out hope ... there’s progress being made”

- Tanisha Hammill