ENT and telemedicine: BPPV telemedicine consults are feasible and could save money

We will be exhibiting the initial results of our tele-medical BPPV consult study as a poster for the Triological Society session at the Combined Otolaryngology Spring Meetings for 2017.Telemedical BPPV Consults Poster .001Discussion posted below for ease of reading:

Within our small sample size, a number of patients who were referred for an evaluation of their dizziness had initially undergone a CT or MRI in the emergency department to evaluate their complaint of dizziness.

Our initial proof of concept study found that for a small sample size, remote diagnosis of BPPV via telemedical consults is possible with high specificity. Based on the specificity, it is appears unlikely that a trained otologist or neurologist reviewing videos of ocular findings of a DHT would misdiagnose a more concerning cause of dizziness as BPPV. Thus, this could easily serve as a screening tool to quickly triage dizzy patients into those requiring more costly work-up and those who do not.

While other authors have suggested using video-oculography [3] or educational algorithms [4] to help distinguish benign versus concerning causes of dizziness, the barriers to adoption of these methods are the cost of equipment and ER workflow. However, due to the prevalence of HIPAA-compliant texting applications and the ubiquity of smartphones, adoption of smartphone-based video consults into an ER workflow is feasible. This is supported by a recent survey of worldwide ER physicians, which found that many wanted assistance with evaluating and distinguishing causes of dizziness [5]. While academic centers may have neurologists or otolarygologists on call, rural and community centers could gain access to these specialists through telemedical means.

Since the DHT is easily taught, having an otolaryngologist interpret the resulting eye movements remotely may increase usage of the test and may lead to cost savings.


Presenting on tele-otology at the AAO-HNS Academy

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We recently presented the data from our study on use by parents of the CellScope iPhone Otoscope at the annual meeting for the Academy of Otolaryngology Head and Neck Surgery.

Overall, the study showed that more research is required on whether parents can reliably use tele-ENT devices to help diagnose their own children. In trained hands, however, it appeared to provide images that are suitable for diagnosis by other physicians. In the future, devices like these could be used as low-cost methods of avoiding unnecessary consults, or providing telemedical access to ENT specialists for specific otological questions in rural area

Above, I have posted the slides from the presentation, and the text of the presentation has been posted below.


Academy presentation

*None of the researchers have any disclosures or ties to the product being discussed. CellScope, Inc. provided the device for this study. 

In areas with limited access to otolaryngologists, tele-otology, or diagnoses based on video recordings of the tympanic membrane, has been validated as a reliable method for remote tympanostomy tube surveillance and diagnosis of otologic diseases.

Based on this concept, a company called CellScope has released an attachment that is able to turn an iPhone into an otoscope, which allows parents to record videos of their child’s ears and send them for remote diagnosis by a physician. This device is available in all 50 states and offers to save time by bypassing a pediatric visit. All of the prior studies validating tele-otoscopy, however, have been based on images recorded by trained professionals. Our study aimed to assess whether tele-otoscopy was reliable for diagnosis when parents took videos, instead of health professionals.

This prospective, randomized, blinded study was conducted at a tertiary academic children’s hospital. To simulate parents using the device at home, parents of children ages 1 month to 17 years were placed in an exam room and given the entire Cellscope box. They were allowed time to set up the device and to watch the company’s tutorial videos. They then used the device without any outside help.

With the attachment device, they attempted to record videos of their child’s ears. To tease out whether reliability was based on the user or the device, a physician subsequently used the device to record the same ears. Finally, the child was examined by the gold standard of pneumatic otoscopy by a pediatric otolaryngologist.

Later, a pediatric otolaryngologist attempted diagnosis based only on the videos. To avoid bias, the pedi-ENT was blinded as to whether the recording was obtained by a parent or a physician. The agreement between video diagnosis and original diagnosis on pneumatic otoscopy was recorded, as well as the number of objective landmarks visualized on each recording.

Overall, eighty ears were enrolled. Using a kappa value to measure inter-rater agreement, we found that there was low agreement between the remote diagnosis based on videos taken by parents and original diagnosis by a pediatric otolaryngologist with pneumatic otoscopy. In contrast, there was high agreement, kappa of 0.71, between diagnosis based on videos of ears taken by a physician and diagnosis by pneumatic otoscopy. There was also nearly no agreement between the number of objective landmarks identified when a parent recorded an ear versus when a physician recorded the same ear

100% of parents watched the tutorial, and 87.5% of parents reported experience using an iPhone. Still, a majority of parent videos provided a limited view of the tympanic membrane landmarks. Many recorded only cerumen, making diagnosis impossible, even when diagnosis had been possible with pneumatic otoscopy.

Based on this poor agreement, we feel further studies are needed to ensure there is no significant risk of missed diagnosis or inappropriate antibiotic prescriptions when parents utilize this service. Furthermore, it is possible that the parent tutorials need improvement.

On the other hand, when used by trained physicians in this limited study, it provided high-quality videos of the tympanic membrane, which other smaller studies have noted as well, and at a price of $79 it is relatively low cost, especially when compared to previously used endoscopes for tele-otoscopy. In the future, ACOs or healthcare systems could potentially utilize tele-otoscopy by frontline providers for tympanostomy tube surveillance to diminish unnecessary specialist consults or avoid missed diagnosis. As we strive towards cost-saving measures, we believe further research on the utility of smartphone otoscopes for tele-otoscopy should be conducted.

*The full manuscript for this paper is currently being prepared for submission

Surgeon Workflow Matters in Device Design

This post was originally posted on the Device Talk blog for Medical Drug and Diagnostic Industry Online. You may find it here: http://www.mddionline.com/blog/devicetalk/surgeon-workflow-matters-device-design-07-28-16

Engineers, take note: paying attention to how a clinician operates can lead to a well-designed device that enjoys widespread adoption.

Manan Shah, MD and Timothy O’Brien, MD

Processed with Snapseed.

In print, Sept. 2016 edition

As clinicians, we know that surgical devices need to fit into the flow of a procedure in order to be used frequently. A key example of this is the coblator device, which is used during tonsillectomies. The coblator demonstrates how one company’s solution to a simple surgical design problem resulted in widespread adoption despite other potential drawbacks.

Tonsillectomies are one of the most common procedures performed by otolaryngologists. Despite the frequency of the procedure, the authors of a recent study from Michigan State University pointed out that there “is no consensus regarding optimal surgical technique or instrument selection.” The most common technique involves the use of a monopolar electrocautery, which applies energy directly to tissues to generate heat and burn the tissue. A newer technique uses the coblator device, which employs low-temperature radiofrequency ablation to break molecular bonds in the tissue. The coblator is used by many otolarygologists even though it costs more than monopolar electrocautery and the data on its benefits are mixed.

Why Do Surgeons Use the Coblator?

The key to grasping the coblator’s popularity is understanding the steps of a tonsillectomy surgery. The coblator device, offered by Smith & Nephew, was designed to combine a suction tool, an ablation tool for dissection, and coagulation tool to control bleeding. This combination fits ideally into the tonsillectomy workflow because surgeons often switch between two tools to achieve all of this during the procedure. From a surgeon’s perspective, the engineers of the coblator were able to combine two separate instruments that surgeons often use successively during a tonsillectomy.

A monopolar cautery burns in a thin line, like a knife. It is a fine instrument that assists in dissecting the tonsils out of the mouth while leaving the throat muscles untouched. But each tonsil has a number of blood vessels that connect to it and supply the tonsil with blood. When the surgeon inevitably comes across one of these vessels, the thin, knife-like burn of the monopolar cautery is often not enough to stop vessel bleeding. As a result, blood quickly fills the mouth, obscuring the surgeon’s view. The surgeon is forced to quickly switch to a suction cautery to remove the blood, regain visualization of the vessel, and then use a more diffuse cone of cautery to coagulate the vessel.

The required switch between the monopolar cautery and the suction cautery takes time, and vessels bleed quickly. While surgical assistants are fast, the surgeon must wait—hand outstretched—for the next device, while watching the patient’s mouth fill with blood. In contrast, with the coblator, the suction cautery is already built into the device, so surgeons can simply move their foot to a different controller pedal in order to activate the coagulation tool and stop the bleeding, without ever removing the instrument from the patient’s mouth. The coblator allows surgeons to single-handedly control the vessel bleed more quickly, decreasing time and blood loss.

Because of how the monopolar electrocautery works, it cannot simply be combined with a suction cautery, which is why a new device was developed. The designers of the coblator understood the workflow of a tonsillectomy, recognized the need for a combined excising and coagulation tool, and were able to produce a new tool that streamlines the workflow and makes the surgeon more comfortable when performing a tonsillectomy.

What Does the Data Say?

The data on the benefits of coblation are uncertain. The concept behind coblation is that using a lower-temperature method to remove the tonsils should lead to less collateral damage to surrounding tissues. The hypothesis is that decreased collateral damage leads to decreased post-operative pain and better healing. Many surgeons adhere to this line of logic and believe that decreased pain to the patient is worth the extra cost of using the coblator device.

Studies using tissue samples have confirmed that there is decreased depth of tissue injury using the coblator compared to the monopolar cautery. However, a number of studies have also found that there is no significant difference in post-op pain survey scores between the two techniques. Some surgeons argue that the pain-survey results are due to poor study design, and a Cochrane review of studies on coblators cites a lack of strong studies as a potential cause of the uncertainty over the outcomes of the two techniques. Further recent studies still have not settled the debate on post-op pain benefit. Accordingly, the comparative data remains unclear as to how the outcomes of the two techniques compare.

While many surgeons assert that they use the coblator with the intension of decreasing post-operative pain for the patient, a review of the literature suggests that there is also a more visceral reason for their preference: the lack of switching tools gives a sense of decreased patient blood loss. But the data is mixed. While some studies show a significant difference in blood loss, others do not, and there are even concerns raised about higher risks of post-operative bleeding. Additionally, while some argue that surgeons use coblation simply to save time, studies fail to show any significant decrease in operative time.

The coblator device costs more than a traditional monopolar electrocautery. While both devices require a stand-alone controller unit, most hospitals already stock the monopolar cautery controller units, because monopolar cautery devices are used in a number of different surgeries. In contrast, the coblation device requires the purchase of an entirely new controller not typically stocked by hospitals. On top of this, the disposable unit for each procedure costs more for the coblator than for the monopolar cautery. The Thottam et al. study from Michigan State University estimated that the average overall combined cost of both the instrument and the anesthesia for the coblation technique amounted to $244.32 per procedure, versus only $30.04 per procedure for the monopolar electrocautery. It is important to understand that the reimbursement for a tonsillectomy is the same, regardless of which device is used. Because neither the hospital nor the surgeon is paid more to use the coblator device, facilities may actually incentivize surgeons to avoid using the coblator to save the hospital money.

Overall, there is not yet an obvious consensus among surgeons over whether to use the coblator or the traditional monopolar electrocautery. Until more conclusive data can be obtained, each surgeon must ultimately utilize the device that they feel provides the best outcome for their patients. An ideal device would have strong clinical data and save our healthcare system resources. However, even with equivocal data and higher costs, the coblator has gained support among surgeons because of its ability to seamlessly fit into the tonsillectomy workflow and address perceived risks by the surgeon.

Personally, I am more familiar with the monopolar electrocautery device, so I prefer using that tool and my patients do well. Still, whenever I run into a case that requires frequent switching between the monopolar electrocautery and the suction cautery, I can’t help but think about the coblator. It is a great example of how engineers understood the needs of the surgeon and developed technology to improve surgical workflow.

Medical device designers and engineers need to understand exactly how a surgeon will interact with their device. For innovators, observing procedures and discovering points of inefficiency, like the tool switching moments in a tonsillectomy, can provide opportunities for improvement. Overall, understanding how to make the healthcare team more comfortable can increase efficiency, and most importantly, benefit the patient.

Manan Shah, MD is a biomedical engineer and current resident in Otolaryngology at the University of Connecticut

Timothy O’Brien, MD is a board certified Otolaryngologist and an assistant clinical professor at the University of Connecticut School of Medicine

The authors have no financial ties, royalties, or relationships with any of the companies or devices in this article.