Benefits to Skin Cancer Screening? The Verdict on OTC Hearing Aids

TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine in Baltimore, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week.

This week’s topics include over-the-counter (OTC) versus fitted hearing aids, screening for skin cancer, chronic pain in U.S. adults, and a new treatment for Clostridium difficile.

Program notes:

0:35 U.S. Preventive Services Task Force (USPSTF) and skin cancer screening

1:36 Data are inconclusive

2:35 Patient can suggest screening

3:22 OTC versus audiologist-fitted hearing aids

4:22 68 adults with mild to moderate hearing loss

5:21 FDA-approved hearing aids

6:23 Different styles available

6:40 New treatment for C. diff

7:40 Infusion from normal people

8:40 Different bacterial populations body-wide

9:15 Chronic pain in U.S. adults

10:16 Chronic pain associated with dementia

11:15 Poor general health and disability

12:05 End

Transcript:

Elizabeth: How many adults in the U.S. have chronic pain?

Rick: Preventing recurrent C. diff infection.

Elizabeth: Can you buy an over-the-counter hearing aid and get good results?

Rick: And screening for cancer when there is skin in the game.

Elizabeth: That’s what we’re talking about this week on TTHealthWatch, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I’m Elizabeth Tracey, a Baltimore-based medical journalist.

Rick: I’m Rick Lange, president of Texas Tech University Health Sciences Center in El Paso, where I’m also dean of the Paul L. Foster School of Medicine.

Elizabeth: With that, why don’t we turn first to yours and that’s in JAMA?

Rick: Elizabeth, this is an update for the U.S. Preventive Services Task Force, USPSTF, that looks at the benefits or harms of screening for skin cancer, skin cancer being the most commonly diagnosed cancer in the United States. There are basically two types of skin cancer: keratinocyte, that involves basal cell and squamous cell, and melanoma.

What the USPSTF did was asked when they look at the benefits and harms of screening for skin cancer, should they recommend it or not recommend it? They come to the conclusion that the data are inconclusive.

Just by looking at a lesion, how good is a primary care physician or even a dermatologist at determining whether it’s skin cancer? We’re right about 40% to 70% of the time. But even if you do determine it, does screening for it by the physician do any better than the person discovering it on themselves? Since most skin cancers really don’t cause morbidity or mortality, it really probably doesn’t matter that the physician find it.

Now, I say that because, again, the data are inconclusive. We don’t have any good studies and we’re talking about asymptomatic individuals that aren’t at high risk. There is no good data that shows that routine screening in them actually helps prevent cancer-related death.

Elizabeth: Let me juxtapose this against my clinical exposures where my primary care doc for sure does one of those skin surveys. There are some parts of our bodies, as we’re well aware of, that it’s pretty tough to take a look at them yourself. What about the utility of that?

Rick: Just in toto they don’t have enough evidence. Now, they’re not saying don’t do it. They just say, gosh, we can’t strongly endorse this. What they say is they’re going to leave it up to the clinician to decide. Most of us that are seeing patients do some sort of a skin survey, especially in individuals that are at a high risk: people that have had a lot of UV [ultraviolet] radiation exposure, those that participated in indoor tanning beds, frequent sunburns, older age, and male sex.

Elizabeth: Okay. That also, of course, suggests that it’s at the discretion of the patient too, where the patient could say, “Look, I really think it would be great if you took a look at like my back,” for example, “and see if there’s anything that looks funky there.”

I’m just wondering and I’d like you to comment on the power of what I’m going to call lukewarm recommendations like this from the USPSTF because there is already pretty significant penetrance of skin assessments into that practice.

Rick: Right. Here is why I like to give credit to the USPSTF. They look at the data and they just report it honestly. I think they do a very good job of it. I’m biased. I think you ought to be doing it because I think there is very little harm in it. You’re just talking about looking at the skin. You’re not talking about doing a biopsy or setting up blood tests. I am predisposed, as you are, to saying, “Gosh, we ought to be doing it,” but we just don’t have that information available.

Elizabeth: Since we’re talking about giving credit for being helpful or not, let’s turn to JAMA Otolaryngology, an issue that’s been percolating up through the firmament, if you will, for many years about the utility of hearing aids. This particular trial does not look at that with regard to its amelioration of the potential for dementia. What it looks at is can you buy an over-the-counter, or OTC, hearing aid and compete or be equivalent to a device that’s fitted by an audiologist?

This is, of course, a really big issue, because here in the United States now these devices have been authorized, and there is energy behind getting people to go out there and purchase them. There is this really rather lackluster piece of data that they cite in this study that says less than 20%, so one in five of U.S. adults, with hearing loss use hearing aids.

Will OTC hearing aids enable people to go out there and buy them themselves without the rather breathtaking outlay that they used to cost? This study took a look at 68 adults with self-perceived mild to moderate hearing loss and they were randomly assigned to either a self-fitting hearing aid that they could purchase OTC or an audiologist-fitted group. They had bilateral hearing aid fitting and the folks who did it themselves went home, and they did a field trial for 2 weeks without any support.

The folks who got the one from the audiologist were able to go back and say, “Hey, we need some help with this,” and then they were reassessed at an additional 4-week time point after they had done the 2 weeks of trial. Their primary outcome measure was self-reported hearing aid benefit using this thing that’s called the Abbreviated Profile of Hearing Aid Benefit.

The upshot is that these groups did not differ significantly. Those folks who got the OTC hearing aids did just as well as those who got them fitted by an audiologist.

Rick: Elizabeth, these are FDA-approved, over-the-counter hearing aids. Since about 2022 when the FDA approved them, it was designed to do two things. One is to make them more available and also to make them less expensive. We’ve talked before about how hearing can impact communication, social activity, even dementia, and perhaps Alzheimer’s. The effort to get hearing aids out to more individuals is really noble.

Until this study, a very well-done study, I really wondered whether the over-the-counter hearing aids were just as good as the audiology-fitted ones. What this shows is they clearly are. Basically, the individuals took them out of the box, they followed the instructions on a smartphone application, put the hearing aids in, and then were off without any help. I think that’s pretty remarkable.

Here are the limitations. This is with a particular brand. I can’t say whether other hearing aids are just as good or not. This is the foundation for saying, gosh, we can make these more available to help more individuals at a lower cost.

Elizabeth: Exactly, and I hope that that’s going to enable people to feel encouraged. When I look at the different styles that are starting to become available, it’s pretty difficult to tell the difference between them and earbuds, for example. Maybe some of that stigma that people have associated with wearing hearing aids will dissipate.

Rick: Like most devices, they’ll continue to get refined. They will be smaller, better, and even less expensive.

Elizabeth: Let’s turn to some more good news back to JAMA for this very common and very troubling bacterial infection, Clostridium difficile, or C. diff as it’s affectionately known, and a new way potentially for preventing recurrent infection.

Rick: It’s the most common healthcare-associated infection in the United States. Just fewer than half a million individuals annually gets C. diff, and it’s got a mortality of about 5%. The mortality is obviously higher in individuals that are older, frailer, and have comorbid conditions.

The major risk factor for this is taking antibiotics. We oftentimes kill bacteria which are helpful. They keep other things in check. Our gut is overgrown with C. diff that causes diarrhea. We treat that with antibiotics to get rid of it, and in a significant number of individuals, as many as 25%, can actually recur.

Besides using antibiotics to treat it, people have used microbiome transplant. They have taken stool samples from normal individuals and infused the individuals either through an NG tube, a nasal gastric tube, or sometimes for an enema. That’s not really very practical. What these investigators did was they identified what are called commensal C. diff strains. They’re normally in the gut. They clonally enlarge them and put them in a small little tablet.

This is a phase II trial. Phase II trials are usually dose trials. They took 79 individuals that were either at high risk for getting recurrent C. diff or had recurrent C. diff. They randomized them to either a high dose of this commensal Clostridium, a medium dose or low dose, and placebo.

I’m just going to talk about the high dose versus placebo. For those that received placebo, 45% of those developed recurrent C. diff. But those that received the commensal Clostridium preparation in the pill for 14 days, 14%, so a decrease of about 75% with really no significant side effects.

Elizabeth: This sounds like just such a great thing and to me seems like one of those no-brainer sort of interventions. Like, hello, we know that we have different bacteria that are all over our bodies and that if we spike different areas of the body with a bunch of different bugs we can get those to kind of become a dominant species versus the Clostridium difficile these other clostridial species can take over.

Rick: You’re absolutely right, and that’s really what they’re doing. They are taking these eight strains, which don’t cause disease, to grow in the gut to basically choke out the C. diff that causes diarrhea. It needs to be confirmed and a larger phase III study, but I don’t see any reason why that won’t progress.

Elizabeth: Now, let us move on to MMWR, Morbidity and Mortality Weekly Report. This is a more sobering and not such a good news topic. This is an assessment of chronic pain among U.S. adults between 2019 and 2021.

They divide pain into two things: chronic pain — i.e., pain that’s lasting longer than 3 months; and high-impact chronic pain — i.e., pain that results in substantial restriction to daily activities. To assess this, they had data from the National Health Interview Survey.

They found just shy of 21% of U.S. adults experienced chronic pain. Just shy of 7% experience high-impact chronic pain. Those populations that experience more of this are non-Hispanic American Indian/Alaskan Native adults, adults identifying as bisexual, and those who are divorced or separated also experience both of these things — i.e., chronic pain and high-impact chronic pain — more often than everyone else.

Rick: Chronic pain is associated with depression, dementia, a higher suicide rate, and importantly, substance abuse and misuse. As you identify, about 50 million adults in the U.S. have experienced it.

Now that we’ve identified a large number of individuals with pain and high-impact pain, we know the risk factors, the next is how to address it. I know this particular article just talks about how large the problem is. It means we really need to take kind of a multimodal or a multidisciplinary approach to addressing it.

Elizabeth: I just wanted to point out that there are subpopulations that are within this catch-all group of U.S. adults who have exceptionally high rates of this, those who are in poor general health and those with disability. They cite that almost 68% and 52% of those folks have chronic pain, and the high-impact chronic pain again disproportionately affecting them at 48%, almost 49%, and 32%. If you have poor general health or you have a disability, those are clearly populations that we need to assess more carefully.

Rick: Right. That means there are two ways to approach it. One is obviously treating the chronic pain. That’s usually a multimodal way of addressing it. But more importantly is actually primary prevention — i.e., injury prevention. Individuals that you described are more likely to suffer injuries are more likely to be predisposed to chronic pain as well.

Elizabeth: Yep, and we sure need something other than opioids, don’t we?

Rick: We do. I mean, really, we need to have more effective pain management that can help prevent the use and misuse of pain medication.

Elizabeth: On that note then, that’s a look at this week’s medical headlines from Texas Tech. I’m Elizabeth Tracey.

Rick: And I’m Rick Lange. Y’all listen up and make healthy choices.