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Identification and support of autistic individuals within the UK Criminal Justice System: a practical approach based upon professional consensus with input from lived experience

Autism spectrum disorder (hereafter referred to as autism) is characterised by difficulties with (i) social communication, social interaction, and (ii) restricted and repetitive interests and behaviours. Estim...

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The effects of telehealth-delivered mindfulness meditation, cognitive therapy, and behavioral activation for chronic low back pain: a randomized clinical trial

Chronic low back pain (CLBP) is a significant problem affecting millions of people worldwide. Three widely implemented psychological techniques used for CLBP management are cognitive therapy (CT), mindfulness ...

Assessing causal links between age at menarche and adolescent mental health: a Mendelian randomisation study

The timing of puberty may have an important impact on adolescent mental health. In particular, earlier age at menarche has been associated with elevated rates of depression in adolescents. Previous research su...

PREX2 contributes to radiation resistance by inhibiting radiotherapy-induced tumor immunogenicity via cGAS/STING/IFNs pathway in colorectal cancer

Colorectal cancer (CRC) lacks established biomarkers or molecular targets for predicting or enhancing radiation response. Phosphatidylinositol-3,4,5-triphosphate-dependent Rac exchange factor 2 (PREX2) exhibit...

Cervical lymph node metastasis prediction from papillary thyroid carcinoma US videos: a prospective multicenter study

Prediction of lymph node metastasis (LNM) is critical for individualized management of papillary thyroid carcinoma (PTC) patients to avoid unnecessary overtreatment as well as undesired under-treatment. Artifi...

Characterizing the polygenic overlap and shared loci between rheumatoid arthritis and cardiovascular diseases

Despite substantial research revealing that patients with rheumatoid arthritis (RA) have excessive morbidity and mortality of cardiovascular disease (CVD), the mechanism underlying this association has not bee...

Patterns of comorbidities in patients with atrial fibrillation and impact on management and long-term prognosis: an analysis from the Prospective Global GLORIA-AF Registry

Clinical complexity, as the interaction between ageing, frailty, multimorbidity and polypharmacy, is an increasing concern in patients with AF. There remains uncertainty regarding how combinations of comorbidi...

Canadians’ use of cannabis for therapeutic purposes since legalization of recreational cannabis: a cross-sectional analysis by medical authorization status

There has been a precipitous decline in authorizations for medical cannabis since non-medical cannabis was legalized in Canada in 2018. This study examines the demographic and health- and medical cannabis-rela...

Interventions on gender equity in the workplace: a scoping review

Various studies have demonstrated gender disparities in workplace settings and the need for further intervention. This study identifies and examines evidence from randomized controlled trials (RCTs) on interve...

Real-world performance of indobufen versus aspirin after percutaneous coronary intervention: insights from the ASPIRATION registry

Indobufen is widely used in patients with aspirin intolerance in East Asia. The OPTION trial launched by our cardiac center examined the performance of indobufen based dual antiplatelet therapy (DAPT) after pe...

Blood leukocytes as a non-invasive diagnostic tool for thyroid nodules: a prospective cohort study

Thyroid nodule (TN) patients in China are subject to overdiagnosis and overtreatment. The implementation of existing technologies such as thyroid ultrasonography has indeed contributed to the improved diagnost...

Childhood urbanicity is associated with emotional episodic memory-related striatal function and common variation in NTRK2

Childhoods in urban or rural environments may differentially affect the risk of neuropsychiatric disorders, possibly through memory processing and neural response to emotional stimuli. Genetic factors may not ...

Inpatient-level care at home delivered by virtual wards and hospital at home: a systematic review and meta-analysis of complex interventions and their components

Technology-enabled inpatient-level care at home services, such as virtual wards and hospital at home, are being rapidly implemented. This is the first systematic review to link the components of these service ...

A practical evidence-based approach to management of type 2 diabetes in children and young people (CYP): UK consensus

Type 2 diabetes in young people is an aggressive disease with a greater risk of complications leading to increased morbidity and mortality during the most productive years of life. Prevalence in the UK and glo...

Comparing the clinical practice and prescribing safety of locum and permanent doctors: observational study of primary care consultations in England

Temporary doctors, known as locums, are a key component of the medical workforce in the NHS but evidence on differences in quality and safety between locum and permanent doctors is limited. We aimed to examine...

SARS-CoV-2, influenza A/B and respiratory syncytial virus positivity and association with influenza-like illness and self-reported symptoms, over the 2022/23 winter season in the UK: a longitudinal surveillance cohort

Syndromic surveillance often relies on patients presenting to healthcare. Community cohorts, although more challenging to recruit, could provide additional population-wide insights, particularly with SARS-CoV-...

A phase II study of belumosudil for chronic graft-versus-host disease in patients who failed at least one line of systemic therapy in China

Chronic graft-versus-host disease (cGVHD) is an immune-related disorder that is the most common complication post-allogenic hematopoietic stem cell transplant. Corticosteroids with or without calcineurin inhib...

Association between genetic risk and adherence to healthy lifestyle for developing age-related hearing loss

Previous studies have shown that lifestyle/environmental factors could accelerate the development of age-related hearing loss (ARHL). However, there has not yet been a study investigating the joint association...

Associations between maternal pre-pregnancy BMI and infant striatal mean diffusivity

It is well-established that parental obesity is a strong risk factor for offspring obesity. Further, a converging body of evidence now suggests that maternal weight profiles may affect the developing offspring...

Evaluation of a hospital-initiated tobacco dependence treatment service: uptake, smoking cessation, readmission and mortality

The National Health Service in England aims to implement tobacco dependency treatment services in all hospitals by 2024. We aimed to assess the uptake of a new service, adapted from the Ottawa Model of Smoking...

Delivering synaptic protein mRNAs via extracellular vesicles ameliorates cognitive impairment in a mouse model of Alzheimer’s disease

Synaptic dysfunction with reduced synaptic protein levels is a core feature of Alzheimer’s disease (AD). Synaptic proteins play a central role in memory processing, learning, and AD pathogenesis. Evidence sugg...

Association between inflammatory bowel disease and cancer risk: evidence triangulation from genetic correlation, Mendelian randomization, and colocalization analyses across East Asian and European populations

Inflammatory bowel disease (IBD), which includes Crohn’s disease (CD) and ulcerative colitis (UC), has been associated with several cancer risks in observational studies, but the observed associations have bee...

Medication non-adherence and self-inflicted violence behaviors among 185,800 patients with schizophrenia in the community: a 12-year cohort study

Despite the importance of medication adherence in treatment effectiveness, little is known about the association between medication non-adherence and self-inflicted violence behaviors. We aimed to assess wheth...

Childhood maltreatment and health in the UK Biobank: triangulation of outcome-wide and polygenic risk score analyses

Childhood maltreatment is common globally and impacts morbidity, mortality, and well-being. Our understanding of its impact is constrained by key substantive and methodological limitations of extant research, ...

Sleep alterations as a function of 88 health indicators

Alterations in sleep have been described in multiple health conditions and as a function of several medication effects. However, evidence generally stems from small univariate studies. Here, we apply a large-s...

Sarcopenic obesity is part of obesity paradox in dementia development: evidence from a population-based cohort study

Sarcopenic obesity, a clinical and functional condition characterized by the coexistence of obesity and sarcopenia, has not been investigated in relation to dementia risk and its onset.

Sex-specific associations between sodium and potassium intake and overall and cause-specific mortality: a large prospective U.S. cohort study, systematic review, and updated meta-analysis of cohort studies

The impact of sodium intake on cardiovascular disease (CVD) health and mortality has been studied for decades, including the well-established association with blood pressure. However, non-linear patterns, dose...

Progress with the Learning Health System 2.0: a rapid review of Learning Health Systems’ responses to pandemics and climate change

Pandemics and climate change each challenge health systems through increasing numbers and new types of patients. To adapt to these challenges, leading health systems have embraced a Learning Health System (LHS...

Regional disparities and risk factors of mortality among patients at high risk of sudden cardiac death in emerging countries: a nonrandomized controlled trial

Comprehensive data on patients at high risk of sudden cardiac death (SCD) in emerging countries are lacking. The aim was to deepen our understanding of the SCD phenotype and identify risk factors for death amo...

Association of in utero HIV exposure with child brain structure and language development: a South African birth cohort study

There is a growing population of children with in utero HIV exposure who are at risk of poor neurodevelopmental outcomes despite avoiding HIV infection. However, the underlying neurobiological pathways are not...

Correction: Transient increased risk of influenza infection following RSV infection in South Africa: findings from the PHIRST study, South Africa, 2016–2018

The original article was published in BMC Medicine 2023 21 :441

Incidence of new-onset hypertension before, during, and after the COVID-19 pandemic: a 7-year longitudinal cohort study in a large population

While the augmented incidence of diabetes after COVID-19 has been widely confirmed, controversial results are available on the risk of developing hypertension during the COVID-19 pandemic.

Incorporating social vulnerability in infectious disease mathematical modelling: a scoping review

Highlighted by the rise of COVID-19, climate change, and conflict, socially vulnerable populations are least resilient to disaster. In infectious disease management, mathematical models are a commonly used too...

SARS-CoV-2 infection is detrimental to pregnancy outcomes after embryo transfer in IVF/ICSI: a prospective cohort study

To explore whether SARS-CoV-2 infection affects the pregnancy outcomes of assisted reproductive techniques (ART).

Risk of encephalitis and meningitis after COVID-19 vaccination in South Korea: a self-controlled case series analysis

Several neurological manifestations shortly after a receipt of coronavirus infectious disease 2019 (COVID-19) vaccine have been described in the recent case reports. Among those, we sought to evaluate the risk...

Autotaxin inhibition attenuates the aortic valve calcification by suppressing inflammation-driven fibro-calcific remodeling of valvular interstitial cells

Patients with fibro-calcific aortic valve disease (FCAVD) have lipid depositions in their aortic valve that engender a proinflammatory impetus toward fibrosis and calcification and ultimately valve leaflet ste...

Improved emotion differentiation under reduced acoustic variability of speech in autism

Socio-emotional impairments are among the diagnostic criteria for autism spectrum disorder (ASD), but the actual knowledge has substantiated both altered and intact emotional prosodies recognition. Here, a Bay...

Polygenic risk score-based phenome-wide association study of head and neck cancer across two large biobanks

Numerous observational studies have highlighted associations of genetic predisposition of head and neck squamous cell carcinoma (HNSCC) with diverse risk factors, but these findings are constrained by design l...

Safety and efficacy of sirolimus in recurrent intravenous leiomyomatosis, pulmonary benign metastatic leiomyomatosis, and leiomyomatosis peritonealis disseminata: a pilot study

Intravenous leiomyomatosis (IVL), pulmonary benign metastatic leiomyomatosis (PBML), and leiomyomatosis peritonealis disseminata (LPD) are leiomyomas with special growth patterns and high postoperative recurre...

The medication-based Rx-Risk Comorbidity Index and risk of hip fracture - a nationwide NOREPOS cohort study

Few previous studies have assessed overall morbidity at the individual level with respect to future risk of hip fracture. The aim of this register-based cohort study was to examine the association between morb...

Paxlovid use is associated with lower risk of cardiovascular diseases in COVID-19 patients with autoimmune rheumatic diseases: a retrospective cohort study

Paxlovid has been shown to be effective in reducing mortality and hospitalization rates in patients with coronavirus disease 2019 (COVID-19). It is not known whether Paxlovid can reduce the risk of cardiovascu...

Evidence linking COVID-19 and the health/well-being of children and adolescents: an umbrella review

Experiences during childhood and adolescence have enduring impacts on physical and mental well-being, overall quality of life, and socioeconomic status throughout one’s lifetime. This underscores the importanc...

Investigating the nexus of metabolic syndrome, serum uric acid, and dementia risk: a prospective cohort study

The global dementia prevalence is surging, necessitating research into contributing factors. We aimed to investigate the association between metabolic syndrome (MetS), its components, serum uric acid (SUA) lev...

Assessing the impact of type 2 diabetes on mortality and life expectancy according to the number of risk factor targets achieved: an observational study

Type 2 diabetes (T2D) is associated with an increased risk of premature death. Whether multifactorial risk factor modification could attenuate T2D-related excess risk of death is unclear. We aimed to examine t...

The optimal antithrombotic strategy for post-stroke patients with atrial fibrillation and extracranial artery stenosis—a nationwide cohort study

In post-stroke atrial fibrillation (AF) patients who have indications for both oral anticoagulant (OAC) and antiplatelet agent (AP), e.g., those with carotid artery stenosis, there is debate over the best anti...

Low awareness of the transitivity assumption in complex networks of interventions: a systematic survey from 721 network meta-analyses

The transitivity assumption is the cornerstone of network meta-analysis (NMA). Violating transitivity compromises the credibility of the indirect estimates and, by extent, the estimated treatment effects of th...

Malaria vaccination: hurdles to reach high-risk children

Ensuring that malaria vaccines deliver maximum public health impact is non-trivial. Drawing on current research, this article examines hurdles that malaria immunization may face to reach high-risk children and...

Efficacy and safety of gut microbiota-based therapies in autoimmune and rheumatic diseases: a systematic review and meta-analysis of 80 randomized controlled trials

Previous randomized controlled trials (RCTs) suggested that gut microbiota-based therapies may be effective in treating autoimmune diseases, but a systematic summary is lacking.

The influence of n-3 polyunsaturated fatty acids on cognitive function in individuals without dementia: a systematic review and dose–response meta-analysis

Omega-3 polyunsaturated fatty acids (n-3 PUFA) have been suggested as a cognitive enhancing agent, though their effect is doubtful. We aimed to examine the effect of n-3 PUFA on the cognitive function of middl...

Correlates of protection and determinants of SARS-CoV-2 breakthrough infections 1 year after third dose vaccination

The emergence of new SARS-CoV-2 variants and the waning of immunity raise concerns about vaccine effectiveness and protection against COVID-19. While antibody response has been shown to correlate with the risk...

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Research articles

Impact of large scale, multicomponent intervention to reduce proton pump inhibitor overuse, esketamine after childbirth for mothers with prenatal depression, glucagon-like peptide 1 receptor agonist use and risk of thyroid cancer, use of progestogens and the risk of intracranial meningioma, delirium and incident dementia in hospital patients, derivation and external validation of a simple risk score for predicting severe acute kidney injury after intravenous cisplatin, quality and safety of artificial intelligence generated health information, large language models and the generation of health disinformation, 25 year trends in cancer incidence and mortality among adults in the uk, cervical pessary versus vaginal progesterone in women with a singleton pregnancy, comparison of prior authorization across insurers, diagnostic accuracy of magnetically guided capsule endoscopy with a detachable string for detecting oesophagogastric varices in adults with cirrhosis, ultra-processed food exposure and adverse health outcomes, added benefit and revenues of oncology drugs approved by the ema, exposure to air pollution and hospital admission for cardiovascular diseases, short term exposure to low level ambient fine particulate matter and natural cause, cardiovascular, and respiratory morbidity, optimal timing of influenza vaccination in young children, effect of exercise for depression, association of non-alcoholic fatty liver disease with cardiovascular disease and all cause death in patients with type 2 diabetes, duration of cpr and outcomes for adults with in-hospital cardiac arrest, clinical effectiveness of an online physical and mental health rehabilitation programme for post-covid-19 condition, atypia detected during breast screening and subsequent development of cancer, publishers’ and journals’ instructions to authors on use of generative ai in academic and scientific publishing, effectiveness of glp-1 receptor agonists on glycaemic control, body weight, and lipid profile for type 2 diabetes, neurological development in children born moderately or late preterm, invasive breast cancer and breast cancer death after non-screen detected ductal carcinoma in situ, all cause and cause specific mortality in obsessive-compulsive disorder, acute rehabilitation following traumatic anterior shoulder dislocation, perinatal depression and risk of mortality, undisclosed financial conflicts of interest in dsm-5-tr, effect of risk mitigation guidance opioid and stimulant dispensations on mortality and acute care visits, update to living systematic review on sars-cov-2 positivity in offspring and timing of mother-to-child transmission, perinatal depression and its health impact, christmas 2023: common healthcare related instruments subjected to magnetic attraction study, using autoregressive integrated moving average models for time series analysis of observational data, demand for morning after pill following new year holiday, christmas 2023: christmas recipes from the great british bake off, effect of a doctor working during the festive period on population health: experiment using doctor who episodes, christmas 2023: analysis of barbie medical and science career dolls, christmas 2023: effect of chair placement on physicians’ behavior and patients’ satisfaction, management of chronic pain secondary to temporomandibular disorders, christmas 2023: projecting complete redaction of clinical trial protocols, christmas 2023: a drug target for erectile dysfunction to help improve fertility, sexual activity, and wellbeing, christmas 2023: efficacy of cola ingestion for oesophageal food bolus impaction, conservative management versus laparoscopic cholecystectomy in adults with gallstone disease, social media use and health risk behaviours in young people, untreated cervical intraepithelial neoplasia grade 2 and cervical cancer, air pollution deaths attributable to fossil fuels, implementation of a high sensitivity cardiac troponin i assay and risk 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Prediction Models and Clinical Outcomes—A Call for Papers

• 1 Department of Medicine, University of Washington, Seattle
• 2 Deputy Editor, JAMA Network Open
• 3 Epidemiology, Rutgers The State University of New Jersey, New Brunswick
• 4 Statistical Editor, JAMA Network Open
• 5 Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts
• 6 Editor, JAMA Network Open

The need to classify disease and predict outcomes is as old as medicine itself. Nearly 50 years ago, the advantage of applying multivariable statistics to these problems became evident. 1 Since then, the increasing availability of databases containing often-complex clinical information from tens or even hundreds of millions of patients, combined with powerful statistical techniques and computing environments, has spawned exponential growth in efforts to create more useful, focused, and accurate prediction models. JAMA Network Open receives dozens of manuscripts weekly that present new or purportedly improved instruments intended to predict a vast array of clinical outcomes. Although we are able to accept only a small fraction of those submitted, we have, nonetheless, published nearly 2000 articles dealing with predictive models over the past 6 years.

The profusion of predictive models has been accompanied by the growing recognition of the necessity for standards to help ensure accuracy of these models. An important milestone was the publication of the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis ( TRIPOD ) guidelines nearly a decade ago. 2 TRIPOD is a reporting guideline intended to enable readers to better understand the methods used in published studies but does not prescribe what actual methods should be applied. Since then, while the field has continued to advance and technology improve, many predictive models in widespread use, when critically evaluated, have been found to neither adhere to reporting standards nor perform as well as expected. 3 , 4

There are numerous reasons why performance of models falls short, even when efforts are made to adhere to methodologic standards. Despite the vast amounts of data that are often brought to bear, they may not be appropriate to the task, or they may have been collected and analyzed in ways that are biased. Additionally, that some models fall short may simply reflect the inherent difficulty of predicting relatively uncommon events that occur as a result of complex biological processes occurring within complex clinical environments. Moreover, clinical settings are highly variable, and predictive models typically perform worse outside of the environments in which they were developed. A comprehensive discussion of these issues is beyond the scope of this article, but as physicist Neils Bohr once remarked, “it is very difficult to predict—especially the future.” 5

Although problems with accuracy are well documented, hundreds of predictive models are in regular use in clinical practice and are frequently the basis for critically important decisions. Many such models have been widely adopted without subsequent efforts to confirm that they actually continue to perform as expected. That is not to say that such models are without utility, because even a suboptimal model may perform better than an unaided clinician. Nevertheless, we believe that a fresh examination of selected, well-established predictive models is warranted if not previously done. JAMA Network Open has published articles addressing prediction of relatively common clinical complications, such as recurrent gastrointestinal bleeding. 6 We think there remains considerable opportunity for research in this vein. In particular, we seek studies that examine current performance of commonly applied clinical prediction rules. We are particularly interested in studies using data from a variety of settings and databases as well as studies that simultaneously assess multiple models addressing the same or similar outcomes.

We also remain interested in the derivation of new models that address a clear clinical need. They should utilize data that are commonly collected as part of routine care, or in principle can be readily extracted from electronic health records. We generally require that prediction models be validated with at least 1 other dataset distinct from the development dataset. In practice, this means data from different health systems or different publicly available or commercial datasets. We note that internal validation techniques, such as split samples, hold-out, k -fold, and others, are not designed to overcome the intrinsic differences between data sources and, therefore, are not suited to quantifying performance externally. While the population to which the models apply should be described explicitly, ideally any such models should be applicable to patients from the wide range of races, ethnicities, and backgrounds commonly encountered in clinic practice. Most importantly, we are interested in examples of models that have been evaluated in clinical settings, assessing their feasibility and potential clinical benefit. This includes studies with negative as well as positive outcomes.

Please see the journal’s Instructions for Authors for information on manuscript preparation and submission. 7 This is not a time-limited call for studies on this topic.

Published: April 12, 2024. doi:10.1001/jamanetworkopen.2024.9640

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2024 Fihn SD et al. JAMA Network Open .

Corresponding Author: Stephan D. Fihn, MD, MPH, Department of Medicine, University of Washington, 325 Ninth Ave, Box 359780, Seattle, WA 98104 ( [email protected] ).

Conflict of Interest Disclosures: Dr Berlin reported receiving consulting fees from Kenvue related to acetaminophen outside the submitted work. No other disclosures were reported.

See More About

Fihn SD , Berlin JA , Haneuse SJPA , Rivara FP. Prediction Models and Clinical Outcomes—A Call for Papers. JAMA Netw Open. 2024;7(4):e249640. doi:10.1001/jamanetworkopen.2024.9640

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Page 1 of 494

Global burden of self-harm and interpersonal violence and influencing factors study 1990–2019: analysis of the global burden of disease study

Widespread concern exists in today’s world regarding self-harm and interpersonal violence. This study to analyze the changes in temporal trends and spatial patterns of risk factors and burdens of self-harm and...

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Novel anthropometric indices for predicting type 2 diabetes mellitus

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Hemorrhagic fever with renal syndrome (HFRS) signals a recurring risk in Eurasia in recent years owing to its continued rise in case notifications and the extension of geographical distribution. This study was...

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• v.8(11); 2020 Nov

Wearable Health Devices in Health Care: Narrative Systematic Review

1 Department of Orthopaedic Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Jiayao Zhang

With the rise of mobile medicine, the development of new technologies such as smart sensing, and the popularization of personalized health concepts, the field of smart wearable devices has developed rapidly in recent years. Among them, medical wearable devices have become one of the most promising fields. These intelligent devices not only assist people in pursuing a healthier lifestyle but also provide a constant stream of health care data for disease diagnosis and treatment by actively recording physiological parameters and tracking metabolic status. Therefore, wearable medical devices have the potential to become a mainstay of the future mobile medical market.

Although previous reviews have discussed consumer trends in wearable electronics and the application of wearable technology in recreational and sporting activities, data on broad clinical usefulness are lacking. We aimed to review the current application of wearable devices in health care while highlighting shortcomings for further research. In addition to daily health and safety monitoring, the focus of our work was mainly on the use of wearable devices in clinical practice.

We conducted a narrative review of the use of wearable devices in health care settings by searching papers in PubMed, EMBASE, Scopus, and the Cochrane Library published since October 2015. Potentially relevant papers were then compared to determine their relevance and reviewed independently for inclusion.

A total of 82 relevant papers drawn from 960 papers on the subject of wearable devices in health care settings were qualitatively analyzed, and the information was synthesized. Our review shows that the wearable medical devices developed so far have been designed for use on all parts of the human body, including the head, limbs, and torso. These devices can be classified into 4 application areas: (1) health and safety monitoring, (2) chronic disease management, (3) disease diagnosis and treatment, and (4) rehabilitation. However, the wearable medical device industry currently faces several important limitations that prevent further use of wearable technology in medical practice, such as difficulties in achieving user-friendly solutions, security and privacy concerns, the lack of industry standards, and various technical bottlenecks.

Conclusions

We predict that with the development of science and technology and the popularization of personalized health concepts, wearable devices will play a greater role in the field of health care and become better integrated into people’s daily lives. However, more research is needed to explore further applications of wearable devices in the medical field. We hope that this review can provide a useful reference for the development of wearable medical devices.

Introduction

In the 1960s, the concept of wearable technology was first proposed by Edward O Thorp [ 1 ], a mathematics professor at the Massachusetts Institute of Technology in the United States. Since then, wearable technology has received considerable attention from researchers all around the world. In recent years, with the development of the internet, intelligent hardware, and big data, wearable technology has developed rapidly in various fields such as health care [ 2 ], education and culture [ 3 ], social networking [ 4 ], and the military [ 5 ]. Some of these technologies are becoming part of people’s daily life in the form of accessories such as smart watches, smart bracelets, armbands, and glasses [ 6 ]. In the field of health care, wearable devices in the form of portable medical or health electronic devices that can be directly worn on the body can be used to perceive, record, analyze, regulate, and intervene to maintain health and can even be used to treat diseases with the support of various technologies for identification, sensing, connection, cloud services, and storage [ 7 ]. By intelligently integrating mechanical functions with microelectronics and computing power, wearable devices can be used to achieve immediate detection of patient signs and laboratory indicators and provide exercise guidance, drug administration reminders, and so on, with the aim of achieving multiparameter, real-time, online, accurate and intelligent detection and analysis of human physiological and pathological information that can be used to carry out self-diagnosis and self-monitoring [ 8 ].

As a standard health care intervention, there are 5 main features of wearable devices [ 9 ]: (1) wireless mobility; (2) interactivity and intelligence; (3) sustainability and durability; (4) simple operation and miniaturization; and (5) wearability and portability. From the perspective of modern medicine, the application of wearable devices in the field of medicine follows the 4P medical model characterized by preventive, predictive, personalized, and participatory medicine [ 10 ]. On one hand, wearable technologies will play a significant role in advancing precision medicine by enabling measurement of clinically relevant parameters showing the health status of individuals [ 11 ]. On the other hand, Loncar-Turukalo et al [ 12 ] also indicated that wearable medical devices play an important role as an enabling technology and as a key driver that facilitated the emergence of connected health care. The operation and implementation of these devices depend on the application of various wearable technologies, including sensor technology, medical chip technology, wireless communication technology, power management technology, display technology, and information feedback technology [ 13 ]. Real-time medical data from these devices are transmitted to the internet for further analyses or feedback from a health care provider.

The development of wearable sensors in the health care market has been relatively slow, despite wearable devices having emerged as a major part of lifestyle and fitness markets. However, the advancement of wearable sensor technology provides enormous opportunities for deployment in health care, especially in connected health care and precision medicine, in which wearable devices can achieve high-quality, real-time measurement of personal health. Although previous reviews have discussed consumer trends in wearable electronics and the application of wearable technology in recreational and sporting activities, data on broad clinical usefulness are lacking. This study reviews the current application of wearable devices in health care. In addition to daily health and safety monitoring, the focus of our work is mainly on the use of wearable devices in clinical practice. We also emphasize their current shortcomings and suggest directions for further research.

A systematic review design with narrative methods was used to analyze the existing evidence. Specifically, a review methodology [ 14 ] was carried out to clarify the types of wearable devices and the current status of their use in health care settings.

Search Strategy

We conducted a comprehensive literature search on January 2, 2020. The following electronic databases were searched with the assistance of an information specialist at the medical library: PubMed, EMBASE, Scopus, and the Cochrane Library. The review was limited to texts published in English between 2015 and 2019 for which abstracts were available. These publication years were chosen due to a dramatic improvement in information technology during that period. The review was also limited to studies of wearable devices in the health care domain. The initial search terms were the following: wearable devices AND health care , wearable technology AND health care , sensor AND wearable AND health care , and wearable AND track AND health care . After reviewing the literature identified through these search terms, we added the search terms monitoring , diseases management , diagnosis OR treatment, and rehabilitation to capture relevant studies found in the references of the papers retrieved from the initial search.

Inclusion and Exclusion Criteria

A total of 960 search results were screened for relevance using titles and abstracts, and 82 papers were fully reviewed and are discussed in this study.

Inclusion research criteria were (1) trials including randomized clinical trials and quasi-experimental studies that have proven the effectiveness of wearable devices; (2) studies focusing on clinical applicability; (3) studies published in peer-reviewed journal in English; (4) studies describing completed research; and (5) studies described in full-text papers. There was no restriction on the location of the studies; therefore, international studies written in English were eligible. Exclusion criteria were papers describing the process of the wearable device design, theoretical papers, books or book chapters, letters, statistical reviews, perspectives, dissertations, editorials, and study protocols.

Study Selection

The research screening process consisted of 4 steps. First, 3 authors (LL, ZJY, and XY) independently screened all titles and abstracts of relevance for this systematic review. Second, the abstracts of all relevant papers were screened for eligibility by the 3 authors. Third, the full texts of eligible publications were obtained and screened (LL) according to the inclusion and exclusion criteria. Differences in opinion were resolved by discussing until a consensus was reached. Finally, to avoid incomplete searching, the references of recent related reviews and the primary studies were manually screened for eligible studies.

After reviewing the title and abstract, the search identified 960 potentially relevant documents. Among them, 82 papers met the inclusion criteria after full-text review ( Figure 1 ).

The flow diagram illustrating the screening process of papers.

Classification of Wearable Devices

Wearable devices developed so far have been designed for use on all parts of the human body and are classified into 3 categories: head, limb, and torso wearable devices [ 15 ].

Head wearable devices mainly include glasses, helmets, headbands, hearing aids, earrings, earphones, and patches [ 12 ]. Among them, Google Glass is a representative type of smart glasses, which has functions such as taking photos, video calls, and GPS positioning, while the application of virtual reality (VR), augmented reality, and mixed reality technology make it suitable for use in areas such as telemedicine, medical education, and intraoperative navigation [ 16 ].

Limb wearable devices mainly include wearable devices worn on the arms, legs, and feet [ 17 , 18 ]. Most of the devices worn on the upper limbs are smart watches, bracelets, and other accessories that can be used to monitor physiological parameters such as body temperature, heart rate, ultraviolet exposure levels, and daily activities [ 19 ]. Most of the devices worn on the lower limbs appear in the form of shoes and socks that monitor movement-related parameters and are mainly used in the field of rehabilitation [ 20 ].

Torso wearable devices mainly include suits, belts, and underwear [ 21 , 22 ]. In recent years, the rapid development of material technology and sensing technology has facilitated the manufacture of electronic products embedded in fabrics or other fabrics that can be used in various biomedical applications. In 2009, a system of clothing providing access to the internet was developed by the Media Technology Laboratory of the Massachusetts Institute of Technology and marked the arrival of a new era of electronic textiles [ 23 ].

Application of Wearable Devices in the Medical Field

In the medical field, wearable devices can connect doctors, patients, clouds, and other parties to understand changes in conditions, to alleviate pain, treat diseases, and facilitate the collection of a large sample of case data, which is helpful for the development of national epidemiology strategies and preventive medicine [ 24 ]. These devices are used mainly in health and safety monitoring [ 25 ], chronic disease management [ 26 ], disease diagnosis and treatment [ 27 ], and rehabilitation [ 28 ].

Health and Safety Monitoring

The health and safety monitoring function of wearable devices is mainly used for older adults, children, pregnant women, and patient groups. The wearer’s gait, walking speed, posture, respiratory rate, blood oxygen, heart rate, blood pressure, energy expenditure, position, and other related parameters are monitored in real time to inform nursing requirements [ 29 ]. For older adults, a high-quality independent life requires solutions to complex nursing needs related to mobility, intelligence, and independent living, which can be provided by the characteristics of wearable technology [ 30 ]. Godfrey et al [ 31 ] used wearable devices for gait and fall quantification in older adults, monitoring the viability of older adults’ daily activities in an unattended home environment and recognizing the main types of movement (walking, standing, sitting, lying) to help older adults to live independently. Jung et al [ 32 ] developed a wearable fall detection system to detect falls by rapidly uploading data for the position of older adult individuals to the medical center and ensuring timely help and treatment. For children, in addition to detecting routine vital signs for health management, wearable technology is a useful tool for tracking children's daily activities [ 33 ]. With the rise of wearable devices, children’s smart watches, bracelets, and backpacks with tracking and positioning functions have emerged in the market. These devices are based on GPS positioning technology to monitor the child’s location and amount of exercise in real time [ 34 ]. Furthermore, wearable technology can also be used to monitor mood. Sequeira et al [ 35 ] have demonstrated the feasibility of wearable tools in the prediction of depressive symptoms in children and adolescents. Health monitoring of pregnant women can be divided into 2 aspects [ 36 ]. On one hand, these applications can be used to monitor the physiological status, emotional state, sleep, and other data before and after conception, while on the other hand, devices can be used to provide immediate feedback on specific problems that occur in the process of child-rearing. Head-med’s Compass Pregnancy Monitor [ 37 ] is the first medical-grade fetal health home monitoring product that is easy to operate and monitors maternal heart rate, fetal heart rate, and uterine activity through a disposable abdominal patch. For patient groups, wearable devices can be used to monitor symptom changes during treatment, which can be used for disease monitoring and efficacy evaluations and can contribute to individualization of the treatment plan [ 29 ]. For example, wearable sensors can be used to monitor the symptoms of patients with Parkinson disease during drug treatment to help doctors adjust drug doses and evaluate the efficacy of new drugs [ 38 ]. van Andel et al [ 39 ] used photoplethysmography in heart rate monitoring of patients with epilepsy and showed excellent seizure detection performance. Ryvlin et al [ 40 ] developed a wearable device that reliably detects generalized tonic-clonic seizures with high sensitivity and specificity to help physicians optimize antiepileptic treatment and reduce the risk of sudden unexpected death in epilepsy.

Chronic Disease Management

Chronic disease management involves changing passive disease treatment into active health monitoring [ 41 ]. Wearable products facilitate data collection and monitoring throughout the user’s entire day, as well as providing dynamic, intelligent, and comprehensive analysis of various indicators to enable medical treatment of chronically ill patients. This technology also facilitates remote monitoring of diseases, adjustment of remote treatment plans, lifestyle management, and other functions through cloud services, which is of great significance in disease control [ 42 ].

Cardiovascular Disease

Cardiovascular diseases can be easily overlooked, with sudden and potentially lethal consequences that require emergency treatment [ 43 ]. They are often accompanied by changes in myocardial electrophysiology at an early stage [ 44 ]. Therefore, improving daily monitoring is important for discovering and controlling heart disease. There are 2 kinds of traditional cardiovascular disease monitoring: invasive and noninvasive. For routine monitoring, noninvasive electrocardiograms (ECG) and Doppler echocardiography are the main means of examining cardiac function [ 45 ]. The 24-hour ambulatory ECG (Holter monitor), which is a relatively mature wearable medical device currently used in the clinic, allows dynamic monitoring, which conventional ECG does not. However, due to suboptimal wearing comfort and the fact that the conductive gel used with electrodes can lead to chest skin allergies and ulcers, its application in home-based daily monitoring is limited. Ultrasonic heart examination can only be used in a hospital setting [ 46 ]. To allow people to manage their own health, researchers at home and abroad have conducted many studies on wearable health monitoring systems, especially for ECG long-term data collection. Tsukada et al [ 47 ] developed a sports vest made from nanofibers coated with an electroconductive polymer to place the ECG electrodes in close contact with the human body. The signal allows display of the ECG signal in real time, and the monitoring data are collected through an app, which increases comfort without risking allergies. The data are uploaded to the cloud and analyzed by a professional physician to realize remote monitoring of heart diseases. In December 2018, Apple developed the Apple Watch Series 4, which combined the functions of ECG and a watch for the first time. In addition, the dial was designed to display a bipolar ECG to monitor occult atrial fibrillation. This device shows similar accuracy in monitoring arrhythmia, atrioventricular block, and QRS duration extension to standard 12-lead ECG recordings [ 48 ]. Kaspar et al [ 49 ] found that the use of a wearable cardioverter-defibrillator protected patients from sudden cardiac arrest when they were treated in nonhospital settings until reimplantation of an implantable cardioverter-defibrillator.

Pulmonary Diseases

Acute exacerbations of chronic obstructive pulmonary disease (COPD) and bronchial asthma can lead to impaired lung function, decreased quality of life, and increased mortality [ 50 ]. Active monitoring of the early signs of a patient’s condition and early treatment can prevent these outcomes. The telehealth program aims to facilitate early identification and timely self-management of acute exacerbations of COPD and bronchial asthma [ 51 ]. For such patients, early detection of progression can help to control the disease [ 52 ]. The emergence of inexpensive wearable devices has enabled people to monitor heart rate, pulse, oxygen saturation, and physical activity continuously, as well as audio to detect cough, breath sounds, and other characteristics [ 53 ]. These signals can be used in predictive analyses to detect early deterioration of lung function. A prospective cohort study [ 54 ] conducted at the University of Toronto evaluated a wearable system that reliably captured nearly continuous patient respiratory rate, oxygen saturation, heart rate, and other data for screening of early COPD deterioration. The results of this study demonstrated the feasibility of using a smart watch for centralized monitoring of patients with COPD. A wearable device developed by Colantonio et al [ 55 ] uses a wireless sensor network system to monitor the patient’s respiratory rate, respiratory sound, blood oxygen saturation, and ECG to evaluate the therapeutic effect of treatments for COPD. Li et al [ 56 ] used acoustic respirators to monitor nighttime wheezing in asthmatic children and found that 57% of patients with well-controlled asthma had a significant number of nighttime wheezing episodes and poor association with routine measurements of lung function. This has helped to develop individualized treatment for children with asthma. However, Rubio et al [ 51 ] reported disappointing results for the use of wearable devices to monitor acute exacerbations of COPD, in part because the parameters monitored (symptoms, pulse oximetry, and lung volume) were not reliable indicators for predicting exacerbation of the disease. It should be pointed out that with advances in sensing technology, wearable systems can also link individual environmental exposure with physiology and subsequent adverse health reactions, providing clues for the pathogenesis of certain lung diseases [ 57 ].

Diabetes represents a group of metabolic diseases characterized by hyperglycemia caused by defects in insulin secretion or impaired biological effects [ 58 ]. Long-term poor glycemic control can lead to damage, dysfunction, and failure of various organ tissues, especially the eyes, kidneys, nerves, heart, and blood vessels [ 59 ]. For patients with diabetes, improving the ability of self-monitoring and self-management of blood glucose levels has contributed to the reduction of diabetes-related morbidity and mortality. There are currently 3 types of medical management products on the market for patients with diabetes: blood glucose level monitoring equipment, injectable insulin, and implantable insulin pumps [ 60 ]. Among them, blood glucose level monitoring products have an important position in blood glucose level control, which is the basic reference for the adjustment of other treatment methods and can also prevent the occurrence of risk events [ 61 ]. Traditional blood glucose level monitoring is performed by directly drawing a venous blood sample or taking a finger-prick blood sample, which is analyzed by a biochemical analyzer. These methods are invasive and inconvenient, especially for patients with diabetes who need to monitor blood glucose level several times a day. Due to the volatility and transience of blood glucose level testing, traditional single-point testing methods do not truly reflect the changes in glucose levels in the body [ 62 ]. With the development of mobile and sensor technologies, wearable dynamic blood glucose level monitoring products have emerged. The GlucoWatch [ 61 ], a noninvasive, painless blood glucose level monitoring product approved by the US Food and Drug Administration in March 2001, has proven its applicability and feasibility in the field of diabetes monitoring products. At present, wearable medical devices widely use indirect measurement methods (minimally invasive or noninvasive) to measure parameters such as blood glucose concentration. The main methods are spectrometry, blood substitution (urine, tears, and tissue fluid), counter-ion electroosmosis, and microwave technology [ 63 , 64 ]. Compared with other methods, the optical method is rapid, is noninvasive, is nonpolluting, is simple to operate, and has become the main method for noninvasive blood glucose level detection. The principle of the measurement is based on concentration-dependent changes in the absorption and reflection characteristics of glucose [ 65 ]. However, the accuracy of the measurement is limited by the overlap of other blood components absorption spectra with the absorption spectrum of glucose [ 64 ]. In addition, Medtronic’s Minimed 670G uses a portable design to integrate blood glucose level monitoring and an insulin pump. The patient can affix the device to the waist and set the daily detection and injection times. Pillalamarri et al [ 66 ] developed a handheld insulin pump using biomedical microelectromechanical systems technology to intelligently control the rate and volume of insulin injections, maintaining blood glucose level within a relatively stable range.

Hypertension

Hypertension is a chronic disease characterized by a sustained increase in arterial blood pressure. It is the most important risk factor for cardiovascular and cerebrovascular diseases, which seriously endanger human health [ 67 ]. Therefore, the accuracy and reliability of blood pressure measurement during the diagnosis and treatment of hypertension is especially important [ 68 ]. Blood pressure can be measured directly and indirectly [ 69 ]. Direct measurement involves percutaneous puncture and catheterization of the aorta. This is an invasive method and is only applicable in critical and difficult cases. Indirect measurement, also known as cuff compression, involves the use of a sphygmomanometer. This is the most commonly used measurement method, but continuous data cannot be obtained [ 70 ]. Noninvasive continuous blood pressure measurement is the trend for the development of wearable blood pressure monitors. At present, wearable devices determine blood pressure by measuring different physiological signals and can be divided into 4 types according to the principle [ 71 ]: (1) flattening tension of the radial artery; (2) volume changes in pulsing blood; (3) speed of pulse wave; and (4) the vibration measurement method. Moreover, wearable blood pressure monitor can be roughly divided into 2 types according to structure: cuff type and sleeveless type. Due to its strong anti-interference and reliability, the cuff type has become the mainstream form of wearable blood pressure measuring devices and are widely used in the market [ 72 ]. This type of wearable device uploads the monitored data to generate a dynamic blood pressure map, which is convenient for patients and doctors. However, during daily continuous monitoring, repeated inflation and deflation of the cuff can cause physical discomfort to the patient, especially at night when the process can cause sleep disturbances [ 70 ]. Therefore, a wearable device that can measure dynamic blood pressure accurately and comfortably without a cuff would be attractive prospect. Zheng et al [ 73 ] used a wearable sleeveless device developed based on optical technology to monitor blood pressure changes by measuring the pulse arrival time (the pulse transit time from the heart to the peripheral blood vessels). In a mixed methods study, Islam et al [ 74 ] demonstrated that wearable blood pressure device measurements compared well against a gold-standard ambulatory device, indicating that this user-friendly method has the potential to enhance blood pressure management in long-term monitoring. However, this type of sleeveless equipment is still in the experimental development stage and has not yet entered the market.

Diagnosis and Treatment of Diseases

A comprehensive understanding of the changes in physiological and pathological indicators during the early stage of disease is critical for timely diagnoses and interventions. Wearable devices are of great significance in the diagnosis and treatment of various diseases by monitoring the changes in vital signs on a real-time basis [ 42 ].

Neurological Disorders

For example, early warning and intervention in the predementia phase of Alzheimer disease are of great significance in delaying the onset and reducing the incidence [ 75 ]. Mild cognitive dysfunction is a major feature of predementia in Alzheimer disease, and diagnostic methods at this stage are not yet fully developed [ 76 ]. Recent studies have shown that gait is a noninvasive biological indicator of cognitive function [ 75 , 77 , 78 ]. By wearing a wearable device, the user’s gait parameters can be collected for early detection of Alzheimer disease. In addition, wearable devices also show good application prospects in the early diagnosis of other neurological diseases. For instance, Mannini et al [ 79 ] developed a wearable device that analyzes gait classification to improve the accuracy of diagnosis of early neurological diseases.

Respiratory Diseases

For patients with obstructive sleep apnea hypopnea syndrome, the application of wearable nocturnal breathing monitoring equipment can improve the accuracy of early diagnosis and can be used at home [ 80 ]. Surrel et al [ 81 ] developed a wearable, accurate, and energy efficient system for monitoring obstructive sleep apnea on a long-term basis.

Cardiac Conduction System Anomalies

For patients who may be at risk of cardiac arrest, a wearable defibrillator can help monitor arrhythmias. Moreover, emergency defibrillation can be performed to restore normal rhythm when cardiac arrest or ventricular fibrillation is detected [ 82 ]. The annual meeting of the American Association for Cancer Research in 2017 also reported that a medical wearable device that delivers alternating currents extends the overall survival of patients with malignant gliomas [ 83 ].

Urinary Diseases

For end-stage renal disease, Gura et al [ 84 ] showed that treatment with a wearable artificial kidney was well tolerated and resulted in effective uremic solute clearance and maintenance of electrolyte and fluid homeostasis.

However, wearable devices still have a long way to go in terms of therapeutic applications compared to their health monitoring functions. It should be pointed out that in recent years, with the rise of VR, augmented reality, and mixed reality technology and the breakthrough of remote technology, wearable equipment has also undergone significant developments for application in settings such as medical education, the formulation of preoperative surgery plans, intraoperative navigation, preoperative doctor-patient communication, and remote consultation [ 16 ]. In our previous studies [ 16 , 85 - 87 ], we successfully implemented mixed reality technology to facilitate preoperative communications between doctors and patients, intraoperative guidance, remote surgical consultation, and surgical navigation through HoloLens glasses.

Rehabilitation

In the field of rehabilitation, wearable devices are used mainly in sports rehabilitation [ 88 ], cognitive rehabilitation [ 89 ], and as rehabilitation aids for people with disabilities [ 90 ].

Sports Rehabilitation

Conditions such as stroke, brain trauma, spinal cord injury, and musculoskeletal injury often lead to the loss or decrease of a patient’s motor ability. The main goal of sports rehabilitation is to restore balance and coordination, to ensure normal joint mobility, and to have sufficient muscle strength and muscular endurance for daily life [ 91 ]. Traditional sports rehabilitation is mainly performed in specific medical institutions by professional rehabilitation practitioners who carry out training to expand the range of motion of joints, enhance muscle strength and endurance, and improve balance and coordination function. This mode of rehabilitation training has the advantages of safe reliable methods and real-time guidance from professionals [ 92 ]. At the same time, there are some shortcomings in the traditional rehabilitation model that cannot be ignored, such as limitations in the time and place of rehabilitation, as well as the boredom and tedium of the process, resulting in lack of adherence among patients, even those who are not older adults, all of which seriously affect the efficacy of sports rehabilitation [ 21 ]. The application of wearable devices, especially in combination with VR, augmented reality, and mixed reality technologies, not only offers the ability to comprehensively monitor and evaluate the rehabilitation activities of patients but also to make the activities more interesting and improve patient adherence [ 92 ].

Limb hemiplegia after brain injury is a difficult problem in sports rehabilitation [ 93 ]. According to The Chinese Stroke Prevention Report in 2018, stroke has become the leading cause of death in China and the leading cause of disability in Chinese adults [ 94 ]. In an aging society, the incidence of stroke is expected to increase in the coming years. Among the various defects caused by stroke, unilateral sensorimotor deficits are very prominent, and 80% of stroke patients have different degrees of gait abnormalities [ 95 ]. At present, lower limb rehabilitation for stroke patients is focused mainly on gait training [ 28 ]. The wearable device can be used to monitor the patient’s gait parameters and provide feedback to help the doctor assess the patient’s recovery in real time so that the treatment plan can be adjusted accordingly. Hsu et al [ 96 ] used a multiplaced wearable sensor to analyze and classify gait characteristics in patients with neurological disorders to guide the selection of rehabilitation exercise regimens. Furthermore, in cases of hemiplegia of a single limb caused by neurological disease, the recovery of arm function lags behind other functions, although the posture and gait may be significantly improved [ 97 ]. Maceira-Elvira et al [ 98 ] used a wearable stroke rehabilitation trainer to support patients performing a personalized upper limb neuromotor training program at home. The built-in wireless sensor records the patient’s exercise volume, analyzes the data and feeds the data back to the patient and therapist, thus bringing additional improvement to the recovery of the patient’s upper limb functions. Using an optimized wearable glove, a team from the University of Pisa used hand posture reconstruction technology to reconstruct hand movements, allowing real-time recording and feedback on a patient’s hand function recovery [ 99 ].

Moreover, in a broad sense, the rehabilitation treatment of spinal cord injury and musculoskeletal injury can be categorized as orthopedic rehabilitation. The use of orthopedic aids is particularly important in the treatment of modern orthopedic rehabilitation. For patients with spinal cord injury, early rehabilitation treatment leads to better the recovery of spinal nerve function mainly through improvements in nerve plasticity [ 100 ]. Traditional rehabilitation treatment, which is guided mainly by professional rehabilitators in hospitals, is a costly process requiring a long period of hospitalization. Furthermore, the qualification requirements of the rehabilitation professionals are often high, and one-on-one professional guidance is not always possible. Many researchers [ 101 , 102 ] have designed wearable artificial exoskeletons based on bionics, the principle of which is to transfer the human body load to the artificial exoskeleton and assist in maintaining the standing posture of patients with spinal cord injury. This approach is also designed to allow the patient to walk slowly with a fixed gait maintained by the dynamics and feedback systems of the artificial exoskeleton, thus avoiding joint dysfunction such as joint stiffness and muscle contracture [ 103 ]. On the other hand, 3 factors are key to the success of treatment of musculoskeletal system injury: reduction, fixation, and functional exercise [ 104 ]. The rehabilitation exercises in the later stage after the injury are the most important. Many orthopedic surgeons in clinical practice often consider only the aesthetics of the operation, neglecting the importance of postoperative limb function rehabilitation. Furthermore, many patients pay insufficient attention to postoperative rehabilitation exercise, with poor adherence, and fear of pain, all of which affect the recovery of the function of the affected limb and greatly reduce the effectiveness of the surgery. The use of wearable devices can encourage patients to perform rehabilitation exercises and allow adjustment of the intensity of rehabilitation training to improve training results based on feedback information [ 103 ]. The electronic-assisted instrument system developed by Zhu et al [ 105 ] promoted the recovery of knee flexion and extension function in patients after total knee arthroplasty. Lee et al [ 106 ] designed an exoskeleton suit that can assist multiple joint movements and measure the direction and angle of movement. Through intuitive recording of the data, which is displayed in a graphical form, the exoskeleton suit provides patients and physicians with information about the effectiveness and extent of the exercise, which is conducive to early rehabilitation and restoration of function.

Cognitive Rehabilitation

Cognitive dysfunction, which is one of the most common sequelae after brain injury, not only influences the quality of life of patients but also puts tremendous pressure on patients’ families and society [ 107 ]. Therefore, improvements in rehabilitation methods are of great significance for cognitive dysfunction. VR glasses have shown great potential in providing treatment options and assessment tools for patients with cognitive impairment [ 108 - 110 ]. VR technology has 3 characteristics, namely immersion, interactivity, and imagination [ 111 ]. By providing visual, auditory, and tactile sensory simulation, patients are provided with an immersive experience that aids cognitive rehabilitation in a controlled stimulation environment and facilitates monitoring of related parameters in real time. VR technology offers the potential to develop a personalized treatment plan for patients with different levels of cognitive impairment by providing virtual reproducible images, which are effective in the recovery of memory impairment. To date, many studies have demonstrated the value of VR-based wearable devices in the rehabilitation of cognitive impairment. According to the characteristics of immersion, Faria et al [ 112 ] designed VR glasses to perform memory recovery training in patients with cognitive dysfunction, reducing their fear of reality and improving their learning and behavioral abilities. Wåhlin et al [ 113 ] used VR training to improve left-sided awareness in chronic stroke patients also increased sporadic interhemispheric functional connectivity within the dorsal attention network.

Rehabilitation Aids for People With Disabilities

Accessories for people with disabilities is another major direction in the field of wearable devices for rehabilitation. Such accessories include intelligent glasses for the blind, smart hearing aids, and intelligent prosthetics.

Using artificial intelligence technology, smart glasses for the blind [ 114 ] not only help individuals with visual impairments interpret information about their surroundings (identified by a pinhole camera, eg, to analyze road condition information in real time) but also aid in making effective decisions. Moreover, smart glasses can help individuals with visual impairment to use a variety of smart home products in a family setting, thus allowing them to improve their quality of life [ 115 ].

The hearing aid is essentially an electroacoustic amplifier [ 116 ]. The acoustic signal is converted into an electrical signal by a microphone, and after amplification, the electrical signal is restored by the receiver to an acoustic signal and transmitted to the human ear. The emergence of intelligent technology has promoted the development of the hearing aid industry, allowing users to autonomously choose the clearest sound they want to hear in a complex and changing environment, freeing them from the disadvantages of hearing disorders.

For patients with limb defects, the prosthesis can not only fill the shape defect but also restore full or partial residual limb function [ 117 ]. Traditional prosthetics are cumbersome, and the invention of wearable smart prostheses is very encouraging for patients with physical disabilities. Intelligent prostheses incorporating robotics have become a hot topic in recent years [ 118 ].

Existing Issues

The development of wearable medical equipment has increased the popularity and quality of health care. Moreover, these developments have, to a certain extent, alleviated the shortage of medical resources in low-income countries and promoted the development of medical care worldwide. However, the wearable medical device industry is still in development and currently faces several important limitations that prevent further use of wearable technology in medical practice.

Barriers to User-Friendly Solutions

For the health care system, the main challenge is to enable the use of these technologies by changing the model of care and by sharing information [ 119 ]. Data collection, transfer, preservation, and sharing require not only the development of technical solutions but also the development of legal infrastructure, which will enable different organizations to share data and responsibilities for patient [ 120 ]. On one hand, patient autonomy in using wearable health devices needs to be kept to help patients to become active participants in their own care [ 119 ]. On the other hand, the duty of clinicians and the responsibilities for misdiagnosis and missed diagnosis due to the use of unreliable or delayed data and false alarms during the use of wearable devices should also be legally regulated [ 121 ].

Security and Privacy Concerns

Through sensor technology, wearable health devices can collect all kinds of user information, such as health information, geographical location, and living habits [ 34 ]. The various formats, large scale, and numerous mobile links of these data may increase the risk of leakage and tampering [ 8 , 35 , 122 , 123 ]. Strategies to ensure the security of the data and improve the public trust are required.

Lack of Industry Standards and Regulations

In the absence of industry standards and regulations, all companies hope to rely on their core products to form their own standards and regulations, making it difficult to integrate resources. So, the establishment and enforcement of new regulatory standards are required [ 71 , 118 ].

Technological Barriers

There are many technical bottlenecks in the applications of wearable medical devices [ 64 , 124 , 125 ]: (1) Data accuracy [ 9 , 24 , 118 , 122 ]: On one hand, the sensor specificity of current wearable device is low, which may lead to overdetection of benign nonclinical related signals, resulting in misdiagnosis, unnecessary examinations, and patient anxiety. On the other hand, low sensor sensitivity may lead to omission of pathological clinically-relevant parameters, resulting in missed diagnosis and delay in treatment. (2) Single function: The compatibility of wearable devices is relatively poor, the functions are mainly concentrated on the level of health monitoring, with slow progress in clinical treatment, and few wearable medical devices have effectively integrated multiple functions [ 27 , 124 ]. (3) Poor battery life: Designing low-power consuming and high-energy storage wearable devices has always been an exciting but challenging issue [ 10 , 120 ]. (4) Equipment safety: Safety and security are primary considerations for medical equipment, closely related to reliability at all system levels [ 12 , 13 ]. Because false alarms would reduce user alertness and prevent user adherence from the feedback provided, efficient mechanisms are needed to detect and diagnose deviations occurring in captured data [ 126 ]. (5) Other issues such as cost, low data collection and processing efficiency, unstable human-computer interaction interfaces, and incomplete construction of big data health clouds need to be further improved [ 9 , 13 , 122 ].

Limitations

There were some limitations in our review. Although some databases are included, our search terms may cause the omission of relevant papers. Due to the exploratory nature of this review, it included a wide range of research designs, and the review will ultimately be limited by the design of the included studies. Although the second and third reviewers used strategies to limit bias through consultation, they also acknowledge the possibility of subjectivity in analyzing the survey results. Additionally, this paper is not intended to be a systematic review, and it is possible to conduct a broader review and find papers suggesting other applications of wearable devices.

Conclusion and Future Directions

Despite many limitations in their application, wearable devices have achieved remarkable success and have brought huge benefits to the aging global population. The authors believe that the following aspects are crucial for future development of the wearable device industry:

• Strengthening oversight of the wearable device industry, formulating specific security rules to protect the privacy and security of personal data, and clarifying the relevant medical responsibilities and rights between doctors and patients.
• Establishment and enforcement of industry standards by taking health care as the main body of information to establish a unified data classification, evaluation system, and industry standards for wearable device to realize the mutual recognition of medical data.
• Technological advancement in wearable health devices to develop low-consumption and high-integration sensor technology; low-power high-performance battery technology; high processing efficiency medical chip technology; and human-computer interaction technology to improve information accuracy, information processing speed, extend battery life, and user experience.
• Combining big data, cloud computing, and IoT—the internet of things—to build a healthy database to develop a complete medical ecosystem. Using this resource, we can fully develop, analyze, and employ medical and health big data to expand the use of wearable devices in other fields, such as telemedicine, preventive medicine, and epidemiology [ 12 ].

By combining smart wearable medical devices with pension services, a smart retirement community can be built to provide high-quality, high-efficiency medical care services. How medical services are sought has also begun to transform from passive medical treatment of disease to community medical models led by prevention, health care, and prediagnosis.

In summary, with the development of science and technology and the popularization of personalized health concepts, wearable devices will inevitably play a greater role in the field of health care and become better integrated into our daily lives. However, more research is needed to explore further applications of wearable devices in the medical field.

Acknowledgments

This work was supported by Foundation for the Science and Technology Commission of Hubei (grant no. 2018AAA067) and the National Natural Science Foundation of China (no. 81974355).

Abbreviations

Conflicts of Interest: None declared.

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Touch can reduce pain, depression and anxiety, say researchers

More consensual touch helps ease or buffer against mental and physical complaints, meta-analysis shows

Whether it is a hug from a friend or the caress of a weighted blanket, the sensation of touch appears to bring benefits for the body and mind, researchers say.

The sense of touch is the first to develop in babies and is crucial in allowing us to experience the environment around us as well as communicate. Indeed, the loss of touch from others during the Covid pandemic hit many hard.

However, while myriad studies have suggested touch is beneficial for our health, few have attempted to draw the vast field of research together.

Now experts have done just that, revealing a simple message: touch helps.

Dr Helena Hartmann, a co-author of the research from University Hospital Essen , said: “More consensual touch events throughout our day can help alleviate or potentially buffer against mental and physical complaints.”

Published in the journal Nature Human Behaviour , the research encompassed 212 previously published studies and included a statistical analysis of 85 studies involving adults and 52 involving newborns.

Among the results, the team found touch was just as beneficial for mental health as physical health – a finding that held for adults and newborns – although touch had a bigger impact on some areas than others.

“Our work illustrates that touch interventions are best suited for reducing pain, depression and anxiety in adults and children as well as for increasing weight gain in newborns,” the researchers write.

The analysis revealed humans gained similar benefits in terms of their physical health when touched by other humans as by objects – such as social robots or weighted blankets.

Hartmann said that was a surprise. “This means we need to undertake more research on the potential of weighted blankets or social robots to improve people’s wellbeing, especially during contact-limiting situations like the recent Covid-19 pandemic,” she said.

The positive impact on mental health was larger for human touch than touch from objects – possibly, the team said, because it involved skin-to-skin contact.

Among other results, the team found touch was beneficial for both healthy and unwell people, although the impact was larger among the latter for mental health benefits.

The type of touch and its duration was not important, although greater frequency was associated with greater benefits in adults.

Further, touching the head was associated with greater health benefits than touching other parts of the body.

The team cautioned that some of the findings could be false positives, while it was not clear if they would hold across different cultures.

Dr Mariana von Mohr, from Royal Holloway, University of London, who was not involved in the work, said if future robots could more accurately replicate the texture and warmth of human skin, they may be able to provide comparable mental health benefits to human touch.

“[These properties are] important because our skin contains specialised sensors, known as C-tactile afferents, which are particularly receptive to gentle, caressing touch and temperature similar to that of human skin, factors that are also thought to facilitate emotional regulation,” she said.

Prof Katerina Fotopoulou, at University College London, said the research gave a bird’s-eye view of the benefits of touch interventions on health.

She cautioned that the work could not offer more specific conclusions, such as the particular types of touch that may be associated with specific health benefits.

Dr Susannah Walker, at Liverpool John Moores University, agreed, noting that many of the studies considered were small and included varied types of touch and different measures of their outcomes. “This means it is hard to draw firm conclusions about why they work,” she said.

Fotopoulou added that the research could fuel new work in the field, including how touch could be used alongside other treatments.

“It is a historical misfortune that we have prioritised talking over touch or other somatic therapies in the past couple of centuries. This review gives us the necessary emphasis and confidence to redress this balance with further, careful study on touch interventions,” she said.

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Mental health care is hard to find, especially for people with Medicare or Medicaid

Rhitu Chatterjee

With rates of suicide and opioid deaths rising in the past decade and children's mental health declared a national emergency , the United States faces an unprecedented mental health crisis. But access to mental health care for a significant portion of Americans — including some of the most vulnerable populations — is extremely limited, according to a new government report released Wednesday.

The report, from the Department of Health and Human Services' Office of Inspector General, finds that Medicare and Medicaid have a dire shortage of mental health care providers.

The report looked at 20 counties with people on Medicaid, traditional Medicare and Medicare Advantage plans, which together serve more than 130 million enrollees — more than 40% of the U.S. population, says Meridith Seife , the deputy regional inspector general and the lead author of the report.

Medicaid serves people on low incomes, and Medicare is mainly for people 65 years or older and those who are younger with chronic disabilities.

The report found fewer than five active mental health care providers for every 1,000 enrollees. On average, Medicare Advantage has 4.7 providers per 1,000 enrollees, whereas traditional Medicare has 2.9 providers and Medicaid has 3.1 providers for the same number of enrollees. Some counties fare even worse, with not even a single provider for every 1,000 enrollees.

"When you have so few providers available to see this many enrollees, patients start running into significant problems finding care," says Seife.

The findings are especially troubling given the level of need for mental health care in this population, she says.

"On Medicare, you have 1 in 4 Medicare enrollees who are living with a mental illness," she says. "Yet less than half of those people are receiving treatment."

Among people on Medicaid, 1 in 3 have a mental illness, and 1 in 5 have a substance use disorder. "So the need is tremendous."

The results are "scary" but "not very surprising," says Deborah Steinberg , senior health policy attorney at the nonprofit Legal Action Center. "We know that people in Medicare and Medicaid are often underserved populations, and this is especially true for mental health and substance use disorder care."

Among those individuals able to find and connect with a provider, many see their provider several times a year, according to the report. And many have to drive a long way for their appointments.

"We have roughly 1 in 4 patients that had to travel more than an hour to their appointments, and 1 in 10 had to travel more than an hour and a half each way," notes Seife. Some patients traveled two hours each way for mental health care, she says.

Mental illnesses and substance use disorders are chronic conditions that people need ongoing care for, says Steinberg. "And when they have to travel an hour, more than an hour, for an appointment throughout the year, that becomes unreasonable. It becomes untenable."

"We know that behavioral health workforce shortages are widespread," says Heather Saunders , a senior research manager on the Medicaid team at KFF, the health policy research organization. "This is across all payers, all populations, with about half of the U.S. population living in a workforce shortage."

But as the report found, that's not the whole story for Medicare and Medicaid. Only about a third of mental health care providers in the counties studied see Medicare and Medicaid patients. That means a majority of the workforce doesn't participate in these programs.

This has been well documented in Medicaid, notes Saunders. "Only a fraction" of providers in provider directories see Medicaid patients, she says. "And when they do see Medicaid patients, they often only see a few."

Lower reimbursement rates and a high administrative burden prevent more providers from participating in Medicaid and Medicare, the report notes.

"In the Medicare program, they set a physician fee rate," explains Steinberg. "Then for certain providers, which includes clinical social workers, mental health counselors and marriage and family therapists, they get reimbursed at 75% of that rate."

Medicaid reimbursements for psychiatric services are even lower when compared with Medicare , says Ellen Weber , senior vice president for health initiatives at the Legal Action Center.

"They're baking in those discriminatory standards when they are setting those rates," says Steinberg.

The new report recommends that the Centers for Medicare & Medicaid Services (CMS) take steps to increase payments to providers and lower administrative requirements. In a statement, CMS said it has responded to those recommendations within the report.

According to research by Saunders and her colleagues at KFF, many states have already started to take action on these fronts to improve participation in Medicaid.

Several have upped their payments to mental health providers. "But the scale of those increases ranged widely across states," says Saunders, "with some states limiting the increase to one provider type or one type of service, but other states having rate increases that were more across the board."

Some states have also tried to simplify and streamline paperwork, she adds. "Making it less complex, making it easier to understand," says Saunders.

But it's too soon to know whether those efforts have made a significant impact on improving access to providers.

CMS has also taken steps to address provider shortages, says Steinberg.

"CMS has tried to increase some of the reimbursement rates without actually fixing that structural problem," says Steinberg. "Trying to add a little bit here and there, but it's not enough, especially when they're only adding a percent to the total rate. It's a really small increase."

The agency has also started covering treatments and providers it didn't use to cover before.

"In 2020, Medicare started covering opioid treatment programs, which is where a lot of folks can go to get medications for their substance use disorder," says Steinberg.

And starting this year, Medicare also covers "mental health counselors, which includes addiction counselors, as well as marriage and family therapists," she adds.

While noteworthy and important, a lot more needs to be done, says Steinberg. "For example, in the substance use disorder space, a lot of addiction counselors do not have a master's degree. And that's one of their requirements to be a counselor in the Medicare program right now."

Removing those stringent requirements and adding other kinds of providers, like peer support specialists, is key to improving access. And the cost of not accessing care is high, she adds.

"Over the past two decades, [in] the older adult population, the number of overdose deaths has increased fourfold — quadrupled," says Steinberg. "So this is affecting people. It is causing deaths. It is causing people to go to the hospital. It increases [health care] costs."

• Centers for Medicare & Medicaid Services
• mental health

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Study: Eating More Than 12 Eggs a Week Shown Not to Impact Cholesterol Levels

Francisco J. Rivera Rosario is a science communications editor experienced in developing all types of science content including, scientific journal articles, infographics, medical educational videos, medication FAQ documents, and more.

• Eggs may not impact cholesterol levels as much as once thought, new research suggests.
• Preliminary results from a new study show that people who ate 12 or more fortified eggs a week had cholesterol levels similar to those who didn’t eat eggs.
• Experts say that when it comes to diet and cholesterol, it is the entirety of one’s diet that ultimately determines heart health, not a single ingredient.

Having an egg-heavy diet may not impact cholesterol levels as much as once thought, new research shows.

Preliminary results from a new study show that people who ate 12 or more fortified eggs a week had similar cholesterol levels to those who didn’t eat eggs at all. The study will be presented at the American College of Cardiology’s Annual Scientific Session on April 6 in Atlanta, Georgia.

Eggs have notoriously received a bad rap due to concerns that they may raise cholesterol levels or worsen heart health. The new research, however, may provide some reassurance that eating eggs may be OK, even for a more high-risk group of people.

“There has been a lot of controversy around how eggs, a food rich in cholesterol, but also protein, can affect cardiovascular health,” Fatima Rodriguez, MD, MPH , associate professor of cardiovascular medicine at Stanford University, told Health . “The question on the health effects of eating large amounts of eggs remains unanswered and this small study gives some insight that can be further studied in a larger study with blinded controls.”

Here’s what you need to know about the newest research on eggs, how they may or may not impact cholesterol levels, and how they can be part of a healthy diet , even for those paying special attention to cardiovascular health.

Impact of an Egg-Heavy Diet on Cholesterol Levels

For the study, funded by Eggland's Best, one of the largest egg producers in the U.S., researchers assessed the effects of consuming a diet high in fortified eggs as compared to a non-egg diet on cardiovascular biomarkers like cholesterol , inflammatory biomarkers, micronutrient levels, and many other endpoints.

Fortified eggs are eggs that have added nutrients like vitamin D , selenium, vitamin B2, 5, and 12, and omega-3 fatty acids. This is a common practice that is done in order to increase a food item’s nutritional value.

140 participants enrolled in the study and were randomized into two groups—the fortified eggs group, which consumed 12 or more fortified eggs a week, and the non-egg diet group, which consumed 2 eggs or fewer per week. Participants were allowed to prepare the eggs in whatever manner they preferred.

All of the participants in the study were over 50 years old, and all had experienced one previous cardiovascular event or had at least two cardiovascular risk factors. Twenty-seven percent of the participants were Black and 24% had diabetes.

Participants had in-person appointments at one month and after four months to assess their vital signs and blood cholesterol levels. Researchers also performed phone check-ins throughout the study to monitor egg consumption.

Researchers looked at the levels of HDL-cholesterol (good cholesterol) and LDL-cholesterol (bad cholesterol), of participants divided into the two groups at the beginning of the study and again after four months.

Results after a four-month follow-up showed that levels of HDL- and LDL-cholesterol were similar between both study groups. Results showed a small reduction of HDL- and LDL-cholesterol in the fortified egg group versus the non-egg diet group, but these changes were not statistically significant.

These results suggest that eating 12 or more fortified eggs each week had no negative effects on blood cholesterol.

This is what is known as a neutral study, a study that shows there is no statistically significant difference between the study groups. This means that, while there is no evidence of harm, there is no evidence of benefit either as it relates to changes in HDL- and LDL-cholesterol levels.

Study results also showed that blood levels of high-sensitivity troponin (a marker of heart damage) decreased slightly in the fortified egg group, and levels of vitamin B increased slightly.

“In this small single-center study, eating more than 12 fortified eggs per week did not change blood cholesterol levels in a clinically meaningful way after four months,” said Rodriguez. “As physicians, our patients may ask us if it’s okay to eat eggs, and this study lends some evidence that this amount of egg consumption may be ok.”

Does This Mean for Eggs Are Actually Heart-Healthy?

While the data provides some evidence suggesting that the consumption of 12 or more eggs did not have negative effects on blood cholesterol, experts suggest results should be taken with some caution.

The small study was a single-center trial, meaning it was conducted according to a single protocol at a single site. The study was also small and relied on patients self-reporting their egg consumption and other dietary patterns. Additionally, patients knew which group they were in (the egg-eating or non-egg-eating group), which could have influenced their health behaviors.

All of these factors “make it difficult to draw strong conclusions from this study,” according to Matthew Tomey, MD , a cardiologist and assistant professor of medicine at the Icahn School of Medicine at Mount Sinai.

“While I agree that the data shared do not provide evidence of harm with eating more eggs, I might stop short of citing the present study as sufficient ‘reassurance’ of the absence of harm,” Tomey told Health .

Information provided about the study also does not go into details regarding the participants’ diets outside of their egg consumption, including whether they ate fewer overall calories or consumed less saturated fat or if these results apply to non-fortified eggs, according to Martha Gulati, MD , professor of cardiology and director of preventive cardiology at Cedars-Sinai.

Experts are also interested in knowing more about the long-term cardiovascular effects of fortified egg consumption. “Four months is a good follow-up period, but I would want a longer study. Hopefully, they have food diaries on participants that will be analyzed, and perhaps this study will have a long follow-up to assess for [cardiovascular] outcomes,” said Gulati.

How to Incorporate Eggs Into a Healthy Diet

Though the study’s results suggest that egg consumption does not impact cholesterol as much as we once thought, when it comes to diet and cholesterol, it is the entirety of one’s diet that ultimately determines heart health.

“Nutrition is complicated and we need to be careful about looking at any one food in isolation,” said Tomey. “The impact of our diet on our health is a product of the totality of our food choices. When we avoid one food, the question comes, how are we replacing it in our diet?”

“I think dietary guidance is always a bit difficult,” added Gulati. “It is never one food that causes heart disease, it is the entire diet and the total saturated fat.”

As for whether eggs are a safe addition to a daily diet, experts agree that the answer is yes—in moderation and as long as the diet is balanced overall.

“Eggs are so commonly part of the American diet, and people want to know if they can eat eggs. It is a common clinical question posed to me,” said Gulati. “My answer is always this: You can consume eggs in moderation, but I need to know more about your diet and if you consume other sources of saturated fats. Because ultimately it is the total saturated fat consumption that will affect your LDL and increase the risk for atherosclerosis.”

For people who are looking to make a change to their diet, Tomey said it’s more important to zoom out and look at the big picture rather than focusing on one ingredient. “I would encourage anyone considering a dietary change for health promotion,” he said, “to evaluate the diet holistically.”

American College of Cardiology. Eggs may not be bad for your heart after all .

Nouhravesh N, et al. Prospective evaluation of fortified eggs related to improvement in the biomarker profile for your health: Primary results from the PROSPERITY trial. Abstract presented at American College of Cardiology's Annual Scientific Session. April 6, 2024, Atlanta, GA.

World Health Organization. Food fortification .

Centers for Disease Control and Prevention. LDL and HDL cholesterol and triglycerides .

Bresee L. The importance of negative and neutral studies for advancing clinical practice . Can J Hosp Pharm . 2017;70(6):403-404. doi:10.4212/cjhp.v70i6.1706

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OU Research Contributes to National Conversation on Neuropsychiatric Side Effects in Children Taking Asthma Drug

Study sheds light on effectiveness of black box warning for Singulair

TULSA, OKLA. – A University of Oklahoma study about a “black box warning” for the asthma drug Singulair continues to influence a national conversation about the medication and its reported neuropsychiatric side effects in children and adolescents. The U.S. Food and Drug Administration assigns black box warnings, sometimes called boxed warnings, as the highest safety-related consumer warning the organization assigns to medications, intended to bring attention to the risks of taking the medication.

In 1998, the FDA approved Singulair, known as montelukast in its generic form, for treating asthma and hay fever. It became a frequently prescribed drug for children struggling with asthma and allergies because it is available in a cherry-flavored chewable pill and may decrease the need for steroids or daily inhaler use. However, in the 26 years since its approval, concerned parents have sounded the alarm about dramatic and sometimes deadly mental health changes they have seen in their children, prompting the FDA to issue a black box warning in 2020.

In their study, researchers at OU-TU School of Community Medicine on the University of Oklahoma’s Tulsa campus sought to understand whether Singulair’s reported negative side effects – including depression, aggression and suicidal thoughts – decreased after the black box warning. Researchers analyzed adverse events reported to the FDA two years before and two years after the warning was issued. In children ages one to 10, reports about most harmful side effects decreased after the warning was issued. However, for youth ages 11 to 17, the outcome was mixed. Reports about side effects actually increased for five of the eight mental health symptoms. Overall, prescriptions for Singulair have decreased only slightly since the black box warning was issued.

In February, the New York attorney general cited the OU findings among other research in a letter to the FDA urging the agency to sound a new, louder alarm about the negative side effects of Singulair in children. Families, too, continue to push for more restrictions on the drug.

A limitation of the study is that the black box warning was issued at the beginning of the COVID-19 pandemic, which had its own effect on the mental health of youth. But for OU researchers, their study

underscores the importance of conversations between doctors and families, said the study’s lead author, Samer Abdelkader, D.O., a pediatrics resident physician in the OU-TU School of Community Medicine.

“As a clinician interested in public health, I hope we can maximize the intent of these warnings and mitigate potential negative impacts on our patients,” Abdelkader said. “I think we can enhance our patient care with better conversations about the benefits and risks of this medication and come to a more informed decision on whether this is the right treatment for each patient.”

Asthma is the most common chronic disease in children, and hay fever (also known as allergic rhinitis) affects the lives of one in five young people, according to the Centers for Disease Control and Prevention. Singulair treats the inflammation and airway swelling that can be dangerous in both conditions. The FDA approved the drug for treating asthma in children as young as 12 months old and for allergies in babies as young as six months old. It is prescribed to millions of children and adolescents each year.

Parents were the first to raise awareness about mental changes they saw in their children who were taking Singulair. Aggression, anxiety, depression, hyperactivity, sleep problems and suicidal thinking were among the symptoms, and several high-profile suicides brought further attention to the drug’s reported problems. Without parents’ advocacy, issues with the drug likely would not have come to light as soon, said Amy Hendrix-Dicken, a senior research assistant and co-author of the paper.

“Parents are the greatest partners in providing health care to children,” she said. “Parents know their kids; our health care providers see them for 15 minutes, and there’s only so much you can glean from a 15-minute visit. We encourage families and patients to speak up, and if they feel like their provider isn’t listening, to find someone who will.”

New information like the black box warning can take a long time to make its way into doctors’ offices large and small, and federal agencies may communicate potential drug problems in differing ways. But health care providers should take the initiative to learn everything they can about the drugs they prescribe, the study’s authors said.

“I no longer say that a side effect cannot be from a medication,” said study co-author and pharmacist Michelle Condren, a professor and vice chair of research in the OU Department of Pediatrics. “I may say, ‘I haven’t seen this side effect before’ or ‘Let me look in the medical literature,’ but I’ll never say that a side effect isn’t possible. This has changed the way I communicate with patients and families. We never want to discount someone who is concerned that a medication could be causing a side effect, but to partner with them to figure things out.”

About the Project

The research team’s study was published in The Journal of Pediatric Pharmacology and Therapeutics and can be accessed at https://doi.org/10.5863/1551-6776-28.8.704.

About the University of Oklahoma

Founded in 1890, the University of Oklahoma is a public research university located in Norman, Oklahoma. As the state’s flagship university, OU serves the educational, cultural, economic and health care needs of the state, region and nation. OU was named the state’s highest-ranking university in  U.S. News & World Report’s  most recent Best Colleges list .  For more information about the university, visit  ou.edu .

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