Compared with traditional SCS devices, the closed-loop feature of the Inceptiv SCS senses neural responses (50 times per second) and is able to automatically adjust stimulation in real time, providing more consistent therapy. The device is implanted through a minimally invasive procedure and utilizes signals generated by the spinal cord in response to electrical stimuli (evoked compound action potentials), which allows a proprietary algorithm to respond and make adjustments in order to maintain the physician’s prescribed stimulation.

The Inceptiv system also offers full-body 1.5T and 3T MRI access with no power or impedance restrictions.

“For patients dealing with chronic pain, every day is a struggle,” said David Carr, vice president and general manager, Pain Interventions within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. “They deserve personalized and effective relief, without compromising future access to MRI. They deserve the comfort that the smallest and thinnest device on the market can provide. We are proud to offer the most cutting-edge solution available today with Inceptiv SCS.”

The Inceptiv SCS is expected to be available in the coming weeks.

Arya Rao, from Harvard Medical School in Boston, and colleagues evaluated ChatGPT performance in polypharmacy management via its binary (yes/no) deprescribing decisions in standardized clinical vignettes.

The researchers found that in yes/no binary deprescribing decisions, ChatGPT universally recommended deprescribing medications regardless of activities of daily living (ADL) status in patients with no overlying cardiovascular disease (CVD) history. Among patients with CVD history, ChatGPT answers varied by technical replicate. The range for total number of medications deprescribed was 2.67 to 3.67 (out of 7) and did not vary with CVD status. However, the number of medications deprescribed increased linearly with severity of ADL impairment. ChatGPT preferentially deprescribed pain medications.

“Our study provides the first use case of ChatGPT as a clinical support tool for medication management,” senior author Marc Succi, MD, from Medically Engineered Solutions in Healthcare Incubator, Innovation in Operations Research Center in Boston, said in a statement. “While caution should be taken to increase accuracy of such models, artificial intelligence-assisted polypharmacy management could help alleviate the increasing burden on general practitioners. Further research with specifically trained artificial intelligence tools may significantly enhance the care of aging patients.”

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Joseph Kassab, MD, from the Cleveland Clinic Foundation, and colleagues assessed the capacity of ChatGPT-4 and Google Bard to deliver accurate recommendations in preventive medicine and primary care. The analysis included 56 questions presented to ChatGPT-4 in June 2023 and Google Bard in October 2023, with responses independently reviewed by two physicians.

The researchers found that after reaching a consensus, 28.6% of ChatGPT-4-generated answers were deemed accurate, 28.6% inaccurate, and 42.8% accurate with missing information. For Bard-generated answers, 53.6% were deemed accurate, 17.8% inaccurate, and 28.6% accurate with missing information. Notable inaccuracies (80%) were detected in both models in response to questions related to the Centers for Disease Control and Prevention as well as immunization.

“A significant proportion of the AI models’ responses were deemed ‘accurate with missing information,’ emphasizing the importance of viewing AI tools as complementary resources when seeking medical information,” the authors write. “Future studies, repeating evaluations at different time points and incorporating a broader range of question formulations for the same topic, would be valuable to account for the evolving nature of the AI models’ training data and algorithm updates.”

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Stephanie Cabral, MD, from the Beth Israel Deaconess Medical Center in Boston, and colleagues compared a large language model’s reasoning abilities against human performance using standards developed for physicians. Responses were compared for selected cases queried in GPT-4 (OpenAI) in August 2023 and from 21 internal medicine attending physicians and 18 residents.

The researchers found that median Revised-IDEA (R-IDEA) scores were 10 (range, 9 to 10) for chatbot, 9 (6 to 10) for attendings, and 8 (4 to 9) for residents. The chatbot had a significantly higher estimated probability of achieving high R-IDEA scores than attendings and residents and had significantly higher R-IDEA scores than attendings and residents. There were no significant differences in attendings’ and residents’ scores. For diagnostic accuracy, the chatbot performed similarly to attendings and residents. Scores were also similar for correct clinical reasoning and cannot-miss diagnosis inclusion. However, the chatbot had more frequent instances of incorrect clinical reasoning (13.8%) than residents (2.8%) but not attendings (12.5%).

“There are multiple steps behind a diagnosis, so we wanted to evaluate whether large language models are as good as physicians at doing that kind of clinical reasoning,” coauthor Adam Rodman, MD, also from Beth Israel, said in a statement. “It’s a surprising finding that these things are capable of showing the equivalent or better reasoning than people throughout the evolution of clinical case.”

Two authors disclosed ties to industry.

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HeadaTerm 2 is a rechargeable TENS device that adheres to an individual’s forehead and releases targeted electrical impulses to increase pain tolerance. The device acts on the supraorbital nerve and supratrochlear nerve, the nerves that transmit migraine pain. The simplified design allows the user to control the device with one button.

The clearance was supported by data from previously approved anti-migraine OTC TENS devices (eg, Cefaly), as well as data from a randomized, double-blind controlled study that compared the effectiveness of TENS therapy to sham in 151 patients who were admitted to the emergency department for acute migraine. 

Efficacy was measured using the visual analog scale (VAS), as assessed by the patients’ perceived changes in pain intensity at 20 and 120 minutes after initiation. The mean VAS change from 0 to 120 minutes was reported to be  -65 ± 25 for the TENS group and -9 ± 2 for the sham group (P <.001). 

Additional clinical studies using the HeadaTerm2 are expected to commence in 2024. The device is available without a prescription and can be ordered at www.emeterm.com and on Amazon. It retails for $99.99.

Rejoyn is the first prescription smartphone app-based digital therapeutic designed to help enhance cognitive control of emotion through a combination of clinically-validated cognitive emotional training exercises for the brain and brief therapeutic lessons. 

The 6-week treatment program consists of 3 parts: cognitive behavioral therapy (CBT)-based lessons, emotional faces memory task exercises, and personalized reminders and messaging. Upon completion of the 6-week program, CBT-based lessons may be revisited for an additional 4 weeks.

The FDA clearance was based on data from the multicenter, remote, double-blinded, randomized, controlled Mirai study (ClinicalTrials.gov Identifier: NCT04770285), which compared Rejoyn to a sham control app in 386 participants aged 22 to 64 years diagnosed with MDD who were on antidepressant medication. The control app included a cognitive training exercise called the shapes memory task. During the treatment period (day 1 [baseline] to week 6), participants had remote telehealth visits.

Findings showed treatment with Rejoyn met the primary endpoint demonstrating a significant mean change from baseline to week 6 in the Montgomery-Åsberg Depression Rating Scale total score in the intent-to-treat population compared with sham (-8.78 vs -6.66, respectively; treatment difference of -2.12 [95% CI, -3.93, -0.32]; P =.0211). Symptom improvement was also observed using patient-reported (Patient Health Questionnaire-9) and clinician-reported (Clinical Global Impressions-Severity) scales. As for safety, no treatment-related adverse events were reported during the trial.

“Rejoyn has a neuromodulatory mechanism designed to act like physical therapy for the brain by delivering personalized, consistent brain-training exercises designed to help improve connections in the brain regions affected by depression,” said Brian Iacoviello, PhD, assistant professor, department of psychiatry, Icahn School of Medicine at Mount Sinai, and scientific advisor at Click Therapeutics. “When stronger and more balanced connections are created, the regions of the brain responsible for processing and regulating emotions are better able to work together and symptoms of depression can improve.”

Rejoyn is expected to be available for download from app stores for iOS^® and Android in the second half of 2024.

NeuroStar Advanced Therapy is a transcranial magnetic stimulation system that uses magnetic fields to induce neural activity in the cerebral cortex. The system consists of an electromagnetic coil, a neurostimulator to generate the electrical stimulus for the coil, a cooling system, a positioning device, and software to control the device. Treatment is performed in an outpatient setting.

The Company uses a proprietary cloud-based software, TrakStar, to remotely activate the new treatment protocol for trained providers. The clearance was based on real-world data from the TrakStar platform, which included 1169 adolescents. Findings showed 78% of patients achieved clinically meaningful improvement in their depression severity. 

According to Neuronetics, data from TrakStar along with published literature showed NeuroStar TMS was “substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy over antidepressant therapy alone,” supporting approval for this patient population.

“Receiving FDA clearance to treat the adolescent segment aged 15 and up is a treatment solution that is long overdue in the mental health industry,” said Keith J. Sullivan, President and CEO of Neuronetics. “We are excited to offer NeuroStar TMS therapy as a new option for young people and for their concerned parents who have struggled to find a treatment they can be confident in.”

Nader Shaikh, MD, from the University of Pittsburgh School of Medicine, and colleagues developed and internally validated an artificial intelligence decision-support tool to interpret videos of the tympanic membrane and enhance accuracy in the diagnosis of AOM. Otoscopic videos of the tympanic membrane captured using a smartphone during outpatient clinic visits at 2 sites in Pennsylvania were analyzed; 1151 videos from 635 children (most younger than 3 years) were included in the study.

The researchers found that diagnostic accuracy was almost identical for the deep residual-recurrent neural network and the decision tree network. Tympanic membrane videos were classified into AOM versus no AOM categories with a sensitivity and specificity of 93.8 and 93.5%, respectively, with the finalized deep residual-recurrent neural network, while the decision tree model had corresponding sensitivity and specificity of 93.7 and 93.3%. Bulging of the tympanic membrane aligned with the predicted diagnosis most closely; in the test set, bulging was present in all 230 cases in which the diagnosis was predicted to be AOM.

“With appropriate training, this tool could be used by a wide range of medical personnel to enhance teaching of otoscopic examination, discussion with colleagues, documentation in the electronic health record, and discussion with parents,” the authors write.

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Maarten G. Poirot, from University of Amsterdam, and colleagues assessed whether a multimodal machine learning approach could predict early sertraline response in patients with major depressive disorder. The analysis included 229 adult outpatients with unmedicated recurrent or chronic major depressive disorder who underwent magnetic resonance neuroimaging and had clinical data collected before and 1 week after treatment.

The researchers found that internal cross-validation performance was significantly better than chance in predicting response to sertraline (balanced accuracy [bAcc], 68%; area under the receiver operating characteristic curve [AUROC], 0.73). Using external cross-validation on data from placebo nonresponders (bAcc, 62%; AUROC, 0.66) and placebo nonresponders who were switched to sertraline (bAcc, 65%; AUROC, 0.68) resulted in differences that suggest specificity for sertraline treatment vs placebo treatment.

“This is important news for patients. Normally, it takes 6 to 8 weeks before it is known whether an antidepressant will work,” coauthor Liesbeth Reneman, MD, PhD, also from University of Amsterdam, said in a statement. “With this method, we can already prevent two-thirds of the number of ‘erroneous’ prescriptions of sertraline and thus offer better quality of care for the patient. Because the drug also has side effects.”

Several authors disclosed ties to the pharmaceutical or medical technology industries.

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The Food and Drug Administration (FDA) has cleared Abbott’s Liberta RC deep brain stimulation (DBS) system for individuals with movement disorders.

The Liberta RC DBS system is indicated for the following:

• Bilateral stimulation of the subthalamic nucleus or the internal globus pallidus as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson disease that are not adequately controlled by medications.
• Unilateral or bilateral stimulation of the ventral intermediate nucleus of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.

According to Abbott, Liberta RC DBS is the smallest rechargeable DBS device on the market with remote programming, approximately the “height and width of a smartwatch face”. Under standard settings, the system requires the fewest recharges, at 10 recharge sessions a year, for most users using a wireless charger system that is placed over the device. For users who prefer a weekly charging schedule, the system needs 30 minutes to charge.

The Liberta RC DBS system works with Abbott’s NeuroSphere Virtual Clinic, which allows individuals to communicate remotely with physicians, ensure proper settings and functionality, and receive new treatment settings. 

Users will be able to control the system via an Abbott supplied patient controller or a secure, compatible iOS device. 

Jacqueline M. Ferguson, PhD, from the Veterans Affairs Palo Alto Health Care System in Menlo Park, California, and colleagues describe trends in clinical outpatient encounters between January 1, 2019, and August 31, 2023, that took place in person, by telephone, and by video before, during, and after the pandemic. Data were included from 277,348,286 Veterans Affairs clinical outpatient encounters.

The researchers found that across all services, there was a sharp decrease in the number of in-person encounters at the start of the pandemic. Decreases in in-person primary care and mental health services were offset by an increase in telephone- and video-based encounters. In-person care became the primary modality among primary care services in January 2021, with a reversal of the increase in video and telephone encounters. Telephone- and video-based care decreased from a peak of 79.6% in April 2020 to 36.7% in April 2023 across all services. The decline was driven by fewer telephone encounters; however, the proportion of video encounters remained relatively stable (11 to 13%). Video-based encounters accounted for 34.5, 3.7, and 3.5% of mental health, subspecialty, and primary care encounters, respectively, by August 2023, while telephone encounters accounted for 20.3, 34.8, and 16.7%, respectively.

“Although these nationwide trends can inform research and policy, they obscure disparities in access to and use of telemedicine that disproportionately affect older adults, individuals in rural regions, and patients from historically marginalized groups,” the authors write.

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The PherDal Kit has been cleared by the Food and Drug Administration (FDA) for over-the-counter home use by individuals who have been unable to conceive through intercourse or have chosen not to conceive through intercourse, for semen collection and the delivery of semen to the vaginal canal.

The kit includes 3 sets of sterile, single-use plastic syringes, semen collection cups, and Instructions for Use. The sterile syringe is designed to deploy the semen intravaginally. The PherDal Kit should be used during the ovulatory phase of the menstrual cycle.

The FDA clearance was based on data from a self-selection study that assessed whether users could accurately determine if they should use the product based on the box label. The study included 47 contraindicated female participants and 40 non-contraindicated female participants. Findings showed 98.9% (86/87) were able to successfully determine whether they should use the PherDal Kit. Among participants with low health literacy (n=34), 97% were able to correctly identify if the product was intended for them or not.

Additionally, findings from a labeling comprehension study, which included 164 biological female participants, showed that at least 90% were able to understand the box label and Instructions for Use and answer the label comprehension questions correctly. 

In a human sperm survival assay (HSSA), the PherDal syringe and collection cup were found not to be toxic to sperm, meeting the HSSA acceptance specification (≥80% of control motility at 24 hours) at all time points assessed.

“Our singular focus in pursuing FDA clearance was to make the PherDal Kit available to every person who is struggling to conceive,” said PherDal Founder and CEO Dr Jennifer Hintzsche, PhD. “Our mission now is to provide access to a sterile, safe, at-home fertility option backed by science – for anyone struggling to conceive, single parents by choice and members of the LGBTQIA+ community.”

The Company is now accepting pre-orders of the PherDal Kit. The first kits are expected to ship by the end of February 2024. The PherDal Kit costs $199.

The Food and Drug Administration (FDA) has cleared Osteoboost, a prescription device for the treatment of postmenopausal women diagnosed with osteopenia.

Osteoboost is a wearable belt device that sends low-frequency vibrations to the lumbar spine and hips. Each treatment session lasts 30 minutes and should be administered during normal daily activities that involve standing and walking.

The FDA clearance was based on data from a double-blind, randomized controlled trial that included postmenopausal women with low bone mass who were not being treated with bone-active medications. 

Study participants were randomly assigned to receive treatment with the belt device in either the active (Osteoboost with vibration; n=64) or sham setting (Osteoboost with noise but no vibration; n=62). The primary endpoint was the change in vertebral strength measured by CT scan from baseline to 12 months.

Findings showed that among women 50 to 60 years of age, Osteoboost was associated with a significant effect on preventing bone loss; the active treatment group lost 0.5% of their vertebral strength, while the sham group lost 3.4% (difference, 2.9%; P =.018). Osteoboost also prevented bone loss in women 60 years and older, though this effect was not considered statistically significant (P =.2). 

Results also showed that participants in the active treatment group who used the device 3 times per week had preservation of 2.36% (P =.014) in bone strength and 1.68% (P =.008) in volumetric bone mineral density, corresponding to an 82% and 85% reduction in the loss of bone strength and bone density, respectively, when compared with sham.

“Today’s groundbreaking decision represents the first non-pharmacological therapy approved to treat this widespread and serious condition,” said Laura Yecies, CEO of Bone Health Technologies. “With Osteoboost, we have a new treatment option, free of serious adverse events, that taps into the body’s natural mechanism to stimulate bone growth.”

Osteoboost is expected to be available later this year. Bone Health Technologies plans to begin accepting pre-orders for the product in the next few months.

The second generation Monarch eTNS System is approximately one-third the size and includes a high-resolution color LCD screen and an optimized user interface. The device is intended for at-home use under the supervision of a caregiver. It works by delivering a low-level electrical pulse to the trigeminal nerve through a small patch that is placed on the patient’s forehead. The patient wears the device during sleep for at least 8 hours. 

The device originally received FDA approval in 2019 based on data from a placebo-controlled clinical trial that included 62 children with moderate to severe ADHD. Findings showed treatment with the eTNS device resulted in statistically significant improvements in ADHD symptoms, based on clinician-administered ADHD Rating Scale score and Clinical Global Impression scales, compared with placebo. The most common side effects reported were drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue. 

“With FDA clearance and a mid-year launch of Monarch 2.0, we can begin scaling our commercial operations to help treat the millions of children in the US and worldwide suffering from ADHD,” said Dr Colin Kealey, President and CEO of NeuroSigma. “In the second half of 2024, our academic partners at UCLA, Seattle Children’s Hospital, and King’s College London are projected to complete enrollment of 375 subjects in 2 multicenter double-blind trials of eTNS for pediatric and adolescent ADHD. We believe that data from these trials will definitively establish the role of eTNS for the treatment of ADHD and further accelerate commercial adoption and payer coverage of this innovative treatment.”

The Food and Drug Administration (FDA) has cleared the DermaSensor device, a noninvasive point-of-care skin cancer evaluation system.

Using spectroscopy and algorithms, the handheld, wireless device assists primary care providers (PCPs) in assessing skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 years and older. The DermaSensor device is intended to help health care providers decide on whether a patient should be referred to a dermatologist. 

The FDA clearance was based on data from a blinded, prospective study that included 1005 patients at 22 primary care sites. A total of 1579 lesions suggestive of skin cancer were scanned using the DermaSensor device. Prior to biopsy, PCPs were asked to predict whether the lesions would be cancerous. The DermaSensor device was found to have an overall sensitivity of 95.5% for detecting malignancy compared with 83% for PCPs (P <.0001). Results also showed a negative result had a 97% chance of being benign.

In an accompanying clinical validation study, 108 PCPs evaluated 50 skin lesions with and without DermaSensor. Results showed that using the elastic scattering spectroscopy device decreased the number of missed skin cancers from 18% to 9%.

“We are entering the golden age of predictive and generative artificial intelligence in health care, and these capabilities are being paired with novel types of technology, like spectroscopy and genetic sequencing, to optimize disease detection and care,” said Cody Simmons, co-founder and CEO  of DermaSensor. “Equipping PCPs, the most abundant clinicians in the country, to better evaluate the most common cancer in the country has been a major, long-standing unmet need in medicine.”

The DermaSensor device should be used in conjunction with all relevant clinical information; it should not be used to confirm a skin cancer diagnosis. The FDA is requiring the manufacturer complete additional clinical validation performance testing with patients from demographic groups representative of the US population.

Nina A. Cooperman, PsyD, from Rutgers Robert Wood Johnson Medical School in Piscataway, New Jersey, and colleagues evaluated the efficacy of MT as usual (usual care) versus telehealth MORE plus usual care among people with an OUD and pain. The analysis included 154 participants.

The researchers found that participants receiving MORE plus usual care had significantly less return to drug use (hazard ratio, 0.58) and MT dropout (hazard ratio, 0.41) than those receiving usual care in an adjusted analysis (e.g., methadone dose and recent drug use, at baseline). Participants receiving MORE plus usual care had significantly fewer days of any drug use (ratio of means, 0.58) than those receiving usual care only through 16 weeks, and a larger percentage maintained methadone adherence (95.5 vs 83.6%). MORE was also associated with significantly reduced depression scores and ecological momentary assessments of pain through 16-week follow-up. Anxiety scores increased in the usual care-only group and decreased in the MORE group, but the difference between groups did not reach significance.

“This randomized clinical trial demonstrated that telehealth MORE was a feasible adjunct to MT with significant effects on drug use, pain, depression, treatment retention, and adherence,” the authors write.

Several authors disclosed ties to various institutions.

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Taking advantage of reduced staffing, cyber criminals may time their attacks to coincide with holiday periods, suggesting that physicians and other personnel at health care institutions should make sure their information technology (IT) team is on alert during the Christmas and New Year’s holidays.

On Thanksgiving Day, November 23, Nashville-based Ardent Health Services and its affiliated entities (Ardent) became aware of a ransomware attack. It affected 30 hospitals across the country. This attack forced the diversion of ambulances to emergency departments at other hospitals and the rescheduling of elective surgeries. Ardent’s IT team immediately began working to understand the event, safeguard data, and regain functionality. Ardent proactively took its network offline, suspending all user access to its information technology applications, including corporate servers, Epic software, internet and clinical programs.

On December 6, Ardent successfully restored functionality to certain clinical and business systems, including Epic, an electronic medical records platform, the company said. Ardent reported this event to law enforcement and retained third-party forensic and threat intelligence advisors.

Vanderbilt University Medical Center (VUMC), which operates 7 hospitals and other facilities across Nashville, Tennessee, was also attacked on Thanksgiving Day. VUMC reported a cybersecurity incident that resulted in unauthorized access to a database serving an extensive health care system that provides medical services to more than 3 million patients annually and employs around 40,000 staff members.

Health Care Is a Prime Target

“Because of the high value of PHI [protected health information], access to clinical research, and the desire to acquire controlled substances, health care remains one of the most targeted industries by threat actors,” said Ryan Witt, vice president for Industry Solutions at Proofpoint in Sunnyvale, California. “Furthermore, health care, like many industries, has struggled to hire an adequate number of cybersecurity professionals.”

The demand for these workers is high, and the ability of health care entities to pay a competitive salary has been a challenge. Moreover, he said health care is heavily regulated, with laws like HIPAA imposing strict data security and privacy requirements. “This complex regulatory environment sometimes requires cybersecurity professionals in health care to have specialized knowledge, which can be a barrier to entry for some candidates,” Witt said. “Cyber criminals understand these staffing challenges and may view the holiday season as an optimal opportunity to strike.”

AI Used to Prevent Cyberattacks

Cyberattacks and data breaches can cripple organizations, not only financially, but in safely delivering patient care. With the rise of AI tools like ChatGPT, there is increased interest in how health care organizations can integrate this technology to prevent phishing, malware, and other malicious activities. For example, IBM Security provides AI-powered solutions that optimize risk analysts’ time. The system reportedly can accelerate threat detection, expedite responses, and protect user identity and datasets. AI-powered risk analysis can produce incident summaries for high-fidelity alerts and automate incident responses. IBM Security touts its AI system as a new way to accelerate alert investigations and triage by an average of 55%.

The technology is specifically designed to balance user access needs and security. AI models can analyze the risk of each login attempt and verify users through behavioral data, simplifying access for verified users and reducing the cost of fraud by up to 90%, according to IBM Security.

“AI may be able to better discriminate from our traditional rules-based approach. I think we are going to see a lot of AI applications in cyber security,” said Christopher A. Longhurst, MD, chief medical officer and chief digital officer for UC San Diego Health in California and executive director for the Jacobs Center for Health Innovation. He recently testified before Congress on issues related to AI in health care, including cybersecurity.

Dr Longhurst is part of a team implementing innovative digital solutions that help improve the patient experience. “I think physicians take privacy and security very seriously, so staying up to date is important,” he said. “These new AI tools hold great promise for liberating physicians from keyboards and allowing them much more time with patients.”

While the Thanksgiving cyberattacks were notable, there are no historical data suggesting that the Christmas and New Year’s holidays are a high-risk period, he said. “It is not always true that holidays pose a heightened risk,” Dr Longhurst said.

Holidays aside, data from Proofpoint’s study Cyber Insecurity in Healthcare 2023 confirm that health care is one of the most attacked industries. Health care organizations are particularly vulnerable to business email compromise, spoofing, and phishing, so they should invest in preventive technologies, Witt said.

But to thwart attacks, health care organizations need to look beyond technology and focus on the people being targeted. “They are your best and last line of defense. Security awareness training should also be part of the security layer,” Witt said.

Sarah Jabbour, from the University of Michigan in Ann Arbor, and colleagues examined the impact of systematically biased AI on clinician diagnostic accuracy in a randomized clinical vignette survey study. Clinicians were shown 9 clinical vignettes of patients hospitalized with acute respiratory failure and were asked to determine the likelihood of pneumonia, heart failure, or chronic obstructive pulmonary disease as the underlying cause. Clinicians were shown 2 vignettes without AI model input to establish baseline diagnostic accuracy and were then randomly assigned to see 6 vignettes with AI model input: three standard-model predictions and 3 systematically biased model predictions.

Overall, 457 clinicians were randomly assigned: 231 and 226 to AI model predictions without and with explanations, respectively. The researchers found that for the three diagnoses, clinicians’ baseline diagnostic accuracy was 73.0%. Clinician accuracy increased over baseline by 2.9 and 4.4 percentage points when shown a standard AI model without and with explanations. Clinician accuracy was reduced by 11.3 percentage points with systematically biased AI model predictions compared with baseline; providing biased AI model predictions with explanations reduced accuracy by 9.1 percentage points, representing a nonsignificant improvement of 2.3 percentage points compared with the systematically biased model.

“Although the findings of the study suggest that clinicians may not be able to serve as a backstop against flawed AI, they can play an essential role in understanding AI’s limitations,” the authors write.

One author reported receiving royalties from a patent from Airstrip.

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EndeavorRx uses sensory and motor stimuli to target and activate the prefrontal cortex of the brain through an action video game experience. The device can be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs. 

The expanded labeling was supported by data from the open-label, STARS-ADHD-Adolescents study (ClinicalTrials.gov Identifier: NCT04897074), which evaluated the effects of EndeavorRx in 162 adolescents aged 13 to 17 years with inattentive or combined-type ADHD. The primary outcome was the change in Test of Variables of Attention (TOVA^®) Attention Comparison Score (ACS) after 4 weeks. 

Results showed treatment with EndeavorRx led to a statistically significant improvement from baseline in TOVA-ACS score after 1 month (P <.0001). Adolescents using EndeavorRx had a significant improvement in ADHD symptoms, as measured by the ADHD Rating Scale-5 (ADHD-RS) inattention subscale and total scale scores (P <.0001 for both); 27.1% of participants achieved at least a 30% reduction in total scores on the ADHD-RS. The most common adverse events reported were headache, frustration, dizziness, emotional reaction, and aggression.

“This latest FDA authorization marks another significant milestone for Akili and the Endeavor products, and more importantly it provides access to adolescents, who have been disproportionately impacted by the ongoing mental health crisis,” said Dr Scott Kollins PhD, Chief Medical Officer at Akili. “Our pivotal study for adolescents demonstrates that EndeavorRx is a safe and effective treatment option for millions of kids and teens struggling with ADHD – particularly important given the ongoing stimulant medication shortage.”

EndeavorRx is available for download with a prescription from the App Store on mobile devices.

Sara Grossman, PharmD, from Long Island University in New York, and colleagues asked the publicly available, free version of ChatGPT 39 questions that had been posed to a drug information service. Two investigators compared ChatGPT responses to benchmark responses based on a literature search.

Of the 39 questions, the researchers reported that ChatGPT provided responses for 72%. Just over one-third of ChatGPT responses (36%) were accurate and complete and had no irrelevant information, whereas 64% had inaccurate or incomplete responses. One-third of the complex questions and 23% of the noncomplex questions were answered in a satisfactory manner.

“Health care professionals and patients should be cautious about using ChatGPT as an authoritative source for medication-related information,” Grossman said in a statement. “Anyone who uses ChatGPT for medication-related information should verify the information using trusted sources.”

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HealthDay News — Mobile app interventions are effective for treating moderate and severe depression, according to a review published online November 20 in JAMA Network Open.

Hayoung Bae, from Korea University in Seoul, and colleagues conducted a systematic literature review to identify randomized clinical trials evaluating the efficacy of mobile app treatments in adults with moderate-to-severe depression.

Based on 13 included studies (16 intervention apps with 1470 participants), the researchers found that the overall pooled effect size of mobile app interventions was 0.50 vs both active and inactive control groups. Significantly lower treatment outcomes were seen with interventions with in-app notifications (standardized mean difference [SMD], 0.45) vs interventions without (SMD, 0.71). App interventions lasting less than 8 weeks were associated with a significantly greater effect size (SMD, 0.77) vs interventions delivered for 8 weeks or longer (SMD, 0.43).

“In this systematic review and meta-analysis of the efficacy associated with app-based interventions for moderate-to-severe depression, a significant reduction was found in depression severity associated with use of app interventions,” the authors write. “These findings are expected to provide developers and researchers in the rapidly evolving field of mHealth with practical insights into the development, prescription, and implementation of app-based depression interventions.”

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The Food and Drug Administration (FDA) has approved Medtronic’s Symplicity Spyral renal denervation (RDN) system as an adjunctive treatment in patients with hypertension in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure (BP).

The Symplicity Spyral RDN system is designed to lower BP by delivering radiofrequency energy through the wall of the renal artery to denervate the kidney from sympathetic nerve hyperactivity. During the procedure, a catheter is inserted into the artery leading to the kidney. Once in place, a physician administers energy to the system to reduce the overactivity of sympathetic nerves surrounding the renal arteries. Upon completion of the treatment, the catheter is removed.

The approval was based on findings from the SPYRAL HTN-OFF study (ClinicalTrials.gov Identifier: NCT02439749), which enrolled patients with uncontrolled hypertension whose antihypertensive medications could be stopped at the start of the trial, and the SPYRAL HTN-ON (ClinicalTrials.gov Identifier: NCT02439775) study, which included patients with uncontrolled hypertension who continued their BP medications during the trial.

In the HTN-OFF trial, the primary endpoint was the change from baseline to 3 months post-procedure in 24-hour ambulatory systolic blood pressure (ASBP). Findings showed the treatment difference between the Symplicity Spyral and sham control groups was -3.9mmHg ASBP, which was considered statistically significant.

In the HTN-ON trial, the primary endpoint was the change from baseline to 6 months post-procedure in 24-hour ASBP. Results showed a nonsignificant 0.03mmHg ASBP reduction in patients treated with Symplicity Spyral vs those who received sham. On the secondary endpoint of office systolic BP, there was a 4.1mmHg greater reduction in the Symplicity Spyral group vs the sham group.

As for safety, no major adverse events were reported in either trial. The Symplicity Spyral RDN system has not been evaluated in patients with type 1 diabetes mellitus, eGFR less than 45mL/min/1.73m², and those younger than 18 years of age. 

“The Symplicity blood pressure procedure is safe and effective, providing significant ‘always on’ blood pressure reductions for patients,” said David Kandzari, MD, chief, Piedmont Heart Institute and Cardiovascular Service and co-principal investigator of the SPYRAL clinical program. “This landmark approval is the culmination of rigorous scientific study and clinical trials, including long-term, sham-controlled studies in the presence and absence of medication, and the largest real-world study.”

The Symplicity Spyral system is expected to be available immediately, according to Medtronic.

The FDA recently approved another RDN system for treating hypertension called the Paradise Ultrasound Renal Denervation system.

The Food and Drug Administration (FDA) has approved the Paradise Ultrasound Renal Denervation (RDN) system as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.

The Paradise system is an ultrasound-based RDN designed to lower blood pressure by reducing the overactivity of sympathetic nerves surrounding the renal arteries. The device delivers 2 to 3 doses of 360-degree ultrasound energy (lasting 7 seconds each) through each of the main renal arteries. By circulating sterile water through the balloon catheter during the procedure, the system also provides a cooling effect that helps protect the renal artery wall.

The approval was based on data from the pivotal, sham-controlled, randomized RADIANCE II trial (ClinicalTrials.gov Identifier: NCT03614260), which assessed the efficacy and safety of the Paradise system in patients with mild to moderate hypertension who were inadequately controlled with medications. Patients were randomly assigned to receive the Paradise system (n=150) or sham (n=74). Prior to randomization, patients were hypertensive and evaluated in an off-medication setting.

Findings showed that treatment with the Paradise system resulted in clinically relevant reductions in daytime ambulatory systolic blood pressure at 2 months compared with sham (baseline-adjusted between-group difference, -6.3mmHg [95% CI, -9.3, -3.2]; P <.001), along with improvements in 6 of 7 secondary blood pressure outcomes. The Paradise system was reported to have a favorable safety profile with no major adverse events observed in either treatment arm.

The RADIANCE clinical program also included the RADIANCE-HTN study (ClinicalTrials.gov Identifier: NCT02649426), which included 2 cohorts: SOLO (patients with hypertension controlled on 1-2 medications or uncontrolled on 0-2 medications) and TRIO (patients with resistant hypertension on standardized triple antihypertensive therapy). Findings from these cohort studies also showed that treatment with the Paradise system led to significant reductions in daytime ambulatory systolic blood pressure (primary endpoint).

“Given the significant blood pressure reductions seen in the ultrasound renal denervation trials, the Paradise Ultrasound Renal Denervation system offers a much-needed advancement in our currently available options to control hypertension,” said site principal investigator Naomi Fisher, MD, Associate Professor of Medicine, Harvard Medical School, and Director of Hypertension Service and Hypertension Innovation, Division of Endocrinology, Diabetes and Hypertension at Brigham and Women’s Hospital. “uRDN has proven efficacy in patients with truly resistant hypertension, a population for whom medication therapy often fails. It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure.”

Xun Wang and Robin A. Cohen, PhD, from the National Center for Health Statistics in Hyattsville, Maryland, describe the percentage of adults who had internet access and used any of 3 components of health information technology: using the internet to look for health or medical information; communicating with a doctor (but not to receive direct care); and looking up medical test results in the past 12 months.

The researchers found that 58.5% of adults used the internet to look for health or medical information during July to December 2022, with a higher prevalence among women than men. Adults ages 30 to 44 years had the highest use of the internet to communicate with a doctor or doctor’s office (47.7%), followed by a reduction with increasing age. Among those who used the internet to look up medical test results, Asian non-Hispanic and White non-Hispanic adults were more likely to do so than American Indian and Alaska Native non-Hispanic, Black non-Hispanic, and Hispanic adults.

“During July to December 2022, 58.5% of US adults used the internet to look for health or medical information, 41.5% used it to communicate with a doctor or doctor’s office, and 46.1% used it to look up medical test results,” the authors write.

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