Evaluating passive physiological data collection during Spravato treatment.

Spravato and other drugs with consciousness-altering effects show significant promise for treating various mental health disorders. However, the effects of these treatments necessitate a substantial degree of patient monitoring which can be burdensome to healthcare providers and may make these treatments less accessible for prospective patients. Continuous passive monitoring via digital devices may be useful in reducing this burden. This proof-of-concept study tested the MindMed Session Monitoring System™ (MSMS™), a continuous passive monitoring system intended for use during treatment sessions involving pharmaceutical products with consciousness-altering effects. Participants completed 129 Spravato sessions with MSMS at an outpatient psychiatry clinic specializing in Spravato treatment. Results indicated high rates of data quality and self-reported usability among participants and health care providers (HCPs). These findings demonstrate the potential for systems such as MSMS to be used in consciousness-altering treatment sessions to assist with patient monitoring.

The digital redesign of mental health: leveraging connected digital technologies for agency-driven patient-focused care.

Digital psychiatry could empower individuals to navigate their context-specific experiences outside healthcare visits. This editorial discusses how leveraging digital health technologies could dramatically transform how we conceptualise mental health and the mental health professional's day-day practice, and how patients could be enabled to navigate their mental health with greater agency.

Correction: An Alternative to the Light Touch Digital Health Remote Study: The Stress and Recovery in Frontline COVID-19 Health Care Workers Study.

[This corrects the article DOI: 10.2196/32165.].

An Alternative to the Light Touch Digital Health Remote Study: The Stress and Recovery in Frontline COVID-19 Health Care Workers Study.

BACKGROUND: Several app-based studies share similar characteristics of a light touch approach that recruit, enroll, and onboard via a smartphone app and attempt to minimize burden through low-friction active study tasks while emphasizing the collection of passive data with minimal human contact. However, engagement is a common challenge across these studies, reporting low retention and adherence. OBJECTIVE: This study aims to describe an alternative to a light touch digital health study that involved a participant-centric design including high friction app-based assessments, semicontinuous passive data from wearable sensors, and a digital engagement strategy centered on providing knowledge and support to participants. METHODS: The Stress and Recovery in Frontline COVID-19 Health Care Workers Study included US frontline health care workers followed between May and November 2020. The study comprised 3 main components: (1) active and passive assessments of stress and symptoms from a smartphone app, (2) objective measured assessments of acute stress from wearable sensors, and (3) a participant codriven engagement strategy that centered on providing knowledge and support to participants. The daily participant time commitment was an average of 10 to 15 minutes. Retention and adherence are described both quantitatively and qualitatively. RESULTS: A total of 365 participants enrolled and started the study, and 81.0% (n=297) of them completed the study for a total study duration of 4 months. Average wearable sensor use was 90.6% days of total study duration. App-based daily, weekly, and every other week surveys were completed on average 69.18%, 68.37%, and 72.86% of the time, respectively. CONCLUSIONS: This study found evidence for the feasibility and acceptability of a participant-centric digital health study approach that involved building trust with participants and providing support through regular phone check-ins. In addition to high retention and adherence, the collection of large volumes of objective measured data alongside contextual self-reported subjective data was able to be collected, which is often missing from light touch digital health studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT04713111; https://clinicaltrials.gov/ct2/show/NCT04713111.

mHealth and wearable technology should replace motor diaries to track motor fluctuations in Parkinson's disease.

Accurately monitoring motor and non-motor symptoms as well as complications in people with Parkinson's disease (PD) is a major challenge, both during clinical management and when conducting clinical trials investigating new treatments. A variety of strategies have been relied upon including questionnaires, motor diaries, and the serial administration of structured clinical exams like part III of the MDS-UPDRS. To evaluate the potential use of mobile and wearable technologies in clinical trials of new pharmacotherapies targeting PD symptoms, we carried out a project (project BlueSky) encompassing four clinical studies, in which 60 healthy volunteers (aged 23-69; 33 females) and 95 people with PD (aged 42-80; 37 females; years since diagnosis 1-24 years; Hoehn and Yahr 1-3) participated and were monitored in either a laboratory environment, a simulated apartment, or at home and in the community. In this paper, we investigated (i) the utility and reliability of self-reports for describing motor fluctuations; (ii) the agreement between participants and clinical raters on the presence of motor complications; (iii) the ability of video raters to accurately assess motor symptoms, and (iv) the dynamics of tremor, dyskinesia, and bradykinesia as they evolve over the medication cycle. Future papers will explore methods for estimating symptom severity based on sensor data. We found that 38% of participants who were asked to complete an electronic motor diary at home missed ~25% of total possible entries and otherwise made entries with an average delay of >4 h. During clinical evaluations by PD specialists, self-reports of dyskinesia were marked by ~35% false negatives and 15% false positives. Compared with live evaluation, the video evaluation of part III of the MDS-UPDRS significantly underestimated the subtle features of tremor and extremity bradykinesia, suggesting that these aspects of the disease may be underappreciated during remote assessments. On the other hand, live and video raters agreed on aspects of postural instability and gait. Our results highlight the significant opportunity for objective, high-resolution, continuous monitoring afforded by wearable technology to improve upon the monitoring of PD symptoms.

A systematic review of feasibility studies promoting the use of mobile technologies in clinical research.

Mobile technologies, such as smart phone applications, wearables, ingestibles, and implantables, are increasingly used in clinical research to capture study endpoints. On behalf of the Clinical Trials Transformation Initiative, we aimed to conduct a systematic scoping review and compile a database summarizing pilot studies addressing mobile technology sensor performance, algorithm development, software performance, and/or operational feasibility, in order to provide a resource for guiding decisions about which technology is most suitable for a particular trial. Our systematic search identified 275 publications meeting inclusion criteria. From these papers, we extracted data including the medical condition, concept of interest captured by the mobile technology, outcomes captured by the digital measurement, and details regarding the sensors, algorithms, and study sample. Sixty-seven percent of the technologies identified were wearable sensors, with the remainder including tablets, smartphones, implanted sensors, and cameras. We noted substantial variability in terms of reporting completeness and terminology used. The data have been compiled into an online database maintained by the Clinical Trials Transformation Initiative that can be filtered and searched electronically, enabling a user to find information most relevant to their work. Our long-term goal is to maintain and update the online database, in order to promote standardization of methods and reporting, encourage collaboration, and avoid redundant studies, thereby contributing to the design and implementation of efficient, high-quality trials.

Digital Medicine: A Primer on Measurement.

Technology is changing how we practice medicine. Sensors and wearables are getting smaller and cheaper, and algorithms are becoming powerful enough to predict medical outcomes. Yet despite rapid advances, healthcare lags behind other industries in truly putting these technologies to use. A major barrier to entry is the cross-disciplinary approach required to create such tools, requiring knowledge from many people across many fields. We aim to drive the field forward by unpacking that barrier, providing a brief introduction to core concepts and terms that define digital medicine. Specifically, we contrast "clinical research" versus routine "clinical care," outlining the security, ethical, regulatory, and legal issues developers must consider as digital medicine products go to market. We classify types of digital measurements and how to use and validate these measures in different settings. To make this resource engaging and accessible, we have included illustrations and figures throughout that we hope readers will borrow from liberally. This primer is the first in a series that will accelerate the safe and effective advancement of the field of digital medicine.

Continuous Sound Collection Using Smartphones and Machine Learning to Measure Cough.

BACKGROUND: Despite the efforts of research groups to develop and implement at least partial automation, cough counting remains impractical. Analysis of 24-h cough frequency is an established regulatory endpoint which, if addressed in an automated manner, has the potential to ease cough symptom evaluation over multiple 24-h periods in a patient-centric way, supporting the development of novel treatments for chronic cough, an unmet clinical need. OBJECTIVES: In light of recent technological advancements, we propose a system based on the use of smartphones for objective continuous sound collection, suitable for automated cough detection and analysis. Two capabilities were identified as necessary for naturalistic cough assessment: (1) recording sound in a continuous manner (sound collection), and (2) detection of coughs from the recorded sound (cough detection). METHODS: This work did not involve any human subject testing or trials. For sound collection, we designed, built, and verified technical parameters of a smartphone application for sound collection. Our cough detection work describes the development of a mathematical model for sound analysis and cough identification. Performance of the model was compared to previously published results of commercially available solutions and to human raters. The compared solutions use the following methods to automatically or semi-automatically assess cough: 24-h sound recording with an ambulatory device with multiple microphones, automatic silence removal, and manual recording review for cough count. RESULTS: Sound collection: the application demonstrated the ability to continuously record sounds using the phone's internal microphone; the technical verification informed the configuration of the technical and user experience parameters. Cough detection: our cough recognition sensitivity to cough as determined by human listeners was 90 at 99.5% specificity preset and 75 at 99.9% specificity preset for a dataset created from publicly available data. CONCLUSIONS: Sound collection: the application reliably collects sound data and uploads them securely to a remote server for subsequent analysis; the developed sound data collection application is a critical first step toward future incorporation in clinical trials. Cough detection: initial experiments with cough detection techniques yielded encouraging results for application to patient-collected data from future studies.

Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research.

Digital health technologies (smartphones, smartwatches, and other body-worn sensors) can act as novel tools to aid in the diagnosis and remote objective monitoring of an individual's disease symptoms, both in clinical care and in research. Nonetheless, such digital health technologies have yet to widely demonstrate value in clinical research due to insufficient data interpretability and lack of regulatory acceptance. Metadata, i.e., data that accompany and describe the primary data, can be utilized to better understand the context of the sensor data and can assist in data management, data sharing, and subsequent data analysis. The need for data and metadata standards for digital health technologies has been raised in academic and industry research communities and has also been noted by regulatory authorities. Therefore, to address this unmet need, we here propose a metadata set that reflects regulatory guidelines and that can serve as a conceptual map to (1) inform researchers on the metadata they should collect in digital health studies, aiming to increase the interpretability and exchangeability of their data, and (2) direct standard development organizations on how to extend their existing standards to incorporate digital health technologies. The proposed metadata set is informed by existing standards pertaining to clinical trials and medical devices, in addition to existing schemas that have supported digital health technology studies. We illustrate this specifically in the context of Parkinson's disease, as a model for a wide range of other chronic conditions for which remote monitoring would be useful in both care and science. We invite the scientific and clinical research communities to apply the proposed metadata set to ongoing and planned research. Where the proposed metadata fall short, we ask users to contribute to its ongoing revision so that an adequate degree of consensus can be maintained in a rapidly evolving technology landscape.

Evaluation of the use of the Scale for the Assessment and Rating of Ataxia (SARA) in healthy volunteers and patients with schizophrenia.

OBJECTIVE: The Scale for the Assessment and Rating of Ataxia (SARA) is a semi-quantitative assessment used to evaluate ataxia. The goal of these studies was to assess and evaluate the utility of this instrument in a Healthy Volunteer (HV) group and subjects with Schizophrenia (SCZ). METHODS: Two studies were completed to collect SARA data, in a HV group and in a stable SCZ group. 177 HVs (18-65 years) and 16 SCZs (18-58 years) provided written consent and were assessed using the SARA. Of 177 HV subjects, 88 had 2 SARA assessments (within 2 days of initial visit) while all 16 SCZ had 3 SARA assessments (within 14 days of initial visit). RESULTS: For the HV group, the mean score ±â€¯Std for the SARA on visit-1 was 0.39 ±â€¯0.72, and 0.34 ±â€¯0.64 for visit-2. The Pearson correlation coefficient between visit-1 and visit-2 was 0.7486 and an ICC of 0.743. For the SCZ group, the mean score for the SARA was 0.63 ±â€¯0.65 on visit-1, 0.84 ±â€¯1.19 on visit-2, and 0.84 ±â€¯0.94 on visit-3. The Pearson correlation coefficient between visit-1 and visit-2 was 0.6545, between visit-1 and visit-3 was 0.6635 and between visit-2 and visit-3 was 0.7613 and an ICC of 0.650. There was no significant difference in baseline SARA scores between the HV and SCZ group p = .063. A statistically significant positive association between age and total SARA scores was observed in HV (r = 0.345) and SCZ (r = 0.676). CONCLUSIONS: A strong association was observed in both the HV and SCZ groups in the reassessment of signs of ataxia using the SARA scale. Both groups demonstrated minimal signs of ataxia, with no statistically significant difference between the two groups in their visit-1 scores.

Do Patients with Pre-Existing Psychiatric Illness Have an Increased Risk of Infection after Injury?

BACKGROUND: Trauma remains a leading cause of death and long term-morbidity. We have shown that patients who sustain traumatic injuries are at increased risk for the development of infectious complications. Psychiatric illnesses (PIs) are also noted to occur frequently among the general population. The presence of a PI has been shown to be a risk factor for the development of infections. Despite the prevalence of both traumatic injuries and psychiatric diseases, there are little data relating the impact of PI on the outcome of patients with trauma. We hypothesize that the presence of a PI will be associated with an increased risk of an infection developing after injury. PATIENTS AND METHODS: This is a five year retrospective chart review of all admitted patients with trauma age 18 years and older. Patients with and without a major psychiatric illness were compared. Demographic data, mechanism of injury and Injury Severity Score (ISS) were reviewed. Co-morbidities included diabetes mellitus, obesity, pre-injury steroid use, and International Classification of Diseases, 9th edition, based psychiatric illness. All infections were diagnosed by microbiologic criteria (urinary tract infection [UTI], ventilator-associated pneumonia) or Centers for Disease Control and Prevention criteria for clinically evident infections (surgical site infection). RESULTS: Of the 11,147 admitted trauma patients, 14.5% had a pre-injury PI diagnosis. The PI patients were older (61.5 ± 0.5 vs. 54.3; p < 0.001), more often female (56% vs. 39.1%; p < 0.001), and had no difference in blunt mechanism rates (88.4% vs. 89.9%; p = 0.06) or median ISS (9 vs. 9; p = 0.06). There was no difference between PI and non-PI patients in pre-injury diabetes mellitus (13.4% vs. 12.7%; p = 0.4), steroid use (2.5% vs. 1.9%; p = 0.1), but patients with PI were more likely to be obese (15.7% vs. 13.6%; p = 0.03). Patients with PI were more likely to have an infection develop (10.4% vs. 7.5%; p < 0.001). The most common infection in both groups was UTI (6.9% vs. 4.2%; p < 0.001). Compared with non-PI patients, adjusting for age, gender, ISS, diabetes mellitus, and obesity, patients with PI were more likely to have an infection develop (odds ratio 1.3, 95% confidence interval = 1.1-1.5) Conclusions: Patients with an underlying PI are at increased risk of having a UTI after traumatic injury. This study identifies a previously unknown independent risk factor for UTIs in patients with trauma. This stresses the need for increased awareness and attention to this vulnerable population.

Twenty-year surgical experience with congenital supravalvar aortic stenosis.

BACKGROUND: Congenital supravalvar aortic stenosis (SVAS) is an arteriopathy associated with Williams-Beuren syndrome and other elastin gene deletions. Our objectives were to review outcomes of congenital SVAS repair and to compare prosthetic patch repair techniques to all-autologous slide aortoplasty. METHODS: Congenital SVAS repairs from 1988 to 2008 were retrospectively reviewed. Peak instantaneous gradients were estimated by Doppler interrogation. Variables were compared by either Student's t test or Fisher's exact test. Risk factors were analyzed by chi(2) test. Survival was estimated by the Kaplan-Meier method. RESULTS: Of 25 primary SVAS repairs, there were 10 all-autologous slide aortoplasties and 15 prosthetic patch aortoplasties. The prosthetic patch group included the Doty technique (n = 9), patch-augmented slide aortoplasty (n = 3), modified Brom technique (n = 1), interposition graft (n = 1), and two-sinus patch with transverse arch augmentation (n = 1). There was 1 early and 1 late death. Cumulative survival for all patients was 96% at 5 and 10 years. Event-free survival did not differ between groups (p = 0.481). There were 2 late reoperations (both were prosthetic patch patients with bicuspid aortic valve: 1 with recurrent aortic valve stenosis and 1 with aortic insufficiency). Bicuspid aortic valve was the only risk factor for reoperation (p = 0.003). Three patients weighing less than 10 kg with diffuse disease underwent attempted slide aortoplasty: 2 required patch augmentation and 1 had a recurrent gradient in less than 1 year postoperatively. CONCLUSIONS: Outcomes after SVAS repair were good by any technique. No advantage to all-autologous slide aortoplasty was apparent at current follow-up. Based on our experience, slide aortoplasty is not recommended for small patients with diffuse disease.

Calibrating urgency: triage decision-making in a pediatric emergency department.

Triage, the first step in the assessment of emergency department patients, occurs in a highly dynamic environment that functions under constraints of time, physical space, and patient needs that may exceed available resources. Through triage, patients are placed into one of a limited number of categories using a subset of diagnostic information. To facilitate this task and standardize the triage decision process, triage guidelines have been implemented. However, these protocols are interpreted differently by highly experienced (expert) nurses and less experienced (novice) nurses. This study investigates the process of triage; the factors that influence triage decision-making, and how the guidelines are used in the process. Using observations and semi-structured interviews of triage nurses, data was collected in the pediatric emergency department of a large Canadian teaching hospital. Results show that in emergency situations (1) triage decisions were often non-analytic and based on intuition, particularly with increasing expertise, and (2) guidelines were used differently by nurses during the triage process. These results suggest that explicit guideline information becomes internalized and implicitly used in emergency triage practice as nurses gain experience. Implications of these results for nursing education and training, and guideline development for emergency care are discussed.

Knowledge integration and reasoning as a function of instruction in a hybrid medical curriculum.

This study investigates the effect of curricular change on knowledge integration and reasoning processes during problem-solving by medical students. The curricular change involved the introduction of problem-based, small group tutorials into a conventional health science curriculum (CC). Students at three levels of training were asked to provide diagnostic explanations of two clinical cases, both before (spontaneous) and after (primed) being exposed to basic science information relevant to the clinical problems. Data were analyzed using techniques of propositional and semantic analysis. Based on theories of instruction and cognition, we expected that the instructional changes would facilitate knowledge integration and influence the reasoning patterns of the students. The results show that students generated fewer inferences and used more information from the basic science text (text-based) to explain the clinical problems. However, they generated a greater number of elaborations during explanations using a mixture of data-driven and hypothesis-driven strategies. The spontaneous and primed problem-solving conditions produced more hypothesis-driven and data-driven strategies, respectively, as would be expected in a hybrid curriculum. We conclude that a) problem-based, small group tutorials facilitate integration of clinical and biomedical knowledge through the use of elaborations and hypothesis-driven strategies, and b) aspects of problem-based learning can be successfully integrated into traditional curricula.

Relationship between small group problem-solving activity and lectures in health science curricula.

Components of problem-based education, such as small group teaching, are being implemented in diverse health curricula. Implementation, however, is often motivated by the intuitive appeal of many problem-based learning components, when what is needed is the detailed examination of how these components support students' integration of knowledge as well as continuity of their learning experiences. This study presents an investigation of the relationship between lecture and small group teaching (SGT) in a medical curriculum. Four problem-oriented SGT sessions representing diverse topics in the first-year curriculum and their corresponding lectures were videotaped and analyzed using techniques of concept mapping, where the broad concepts from the lectures were identified and matched to the case-specific concepts in the small group sessions. The results show that lectures function as an anchor for the students' discussion of issues relevant to clinical problem-solving and interventions in small group sessions. These discussions extended to contextual aspects of clinical practice that were not dealt with in the lectures, such as ethical/cultural issues around the treatment of patients. Furthermore, small group environments were found to promote discussions that allowed the integration of information from different sources and encompassed concepts across a number of disciplines. These results suggest that carefully designed small group sessions serve the purposes of 1) illustrating broader concepts in lectures to case-specific, clinically relevant problem-solving and 2) promoting knowledge integration from diverse sources of information. The implications of these results for learning and reasoning in health science curricula are discussed.