Efficacy of the Flo App in Improving Health Literacy, Menstrual and General Health, and Well-Being in Women: Pilot Randomized Controlled Trial.

BACKGROUND: Reproductive health literacy and menstrual health awareness play a crucial role in ensuring the health and well-being of women and people who menstruate. Further, awareness of one's own menstrual cycle patterns and associated symptoms can help individuals identify and manage conditions of the menstrual cycle such as premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). Digital health products, and specifically menstrual health apps, have the potential to effect positive change due to their scalability and ease of access. OBJECTIVE: The primary aim of this study was to measure the efficacy of a menstrual and reproductive health app, Flo, in improving health literacy and health and well-being outcomes in menstruating individuals with and without PMS and PMDD. Further, we explored the possibility that the use of the Flo app could positively influence feelings around reproductive health management and communication about health, menstrual cycle stigma, unplanned pregnancies, quality of life, work productivity, absenteeism, and body image. METHODS: We conducted 2 pilot, 3-month, unblinded, 2-armed, remote randomized controlled trials on the effects of using the Flo app in a sample of US-based (1) individuals who track their cycles (n=321) or (2) individuals who track their cycles and are affected by PMS or PMDD (n=117). RESULTS: The findings revealed significant improvements at the end of the study period compared to baseline for our primary outcomes of health literacy (cycle tracking: D̄=1.11; t311=5.73, P<.001; PMS or PMDD: D̄=1.20; t115=3.76, P<.001) and menstrual health awareness (D̄=3.97; t311=7.71, P<.001), health and well-being (D̄=3.44; t311=5.94, P<.001), and PMS or PMDD symptoms burden (D̄=-7.08; t115=-5.44, P<.001). Improvements were also observed for our secondary outcomes of feelings of control and management over health (D̄=1.01; t311=5.08, P<.001), communication about health (D̄=0.93; t311=2.41, P=.002), menstrual cycle stigma (D̄=-0.61; t311=-2.73, P=.007), and fear of unplanned pregnancies (D̄=-0.22; t311=-2.11, P=.04) for those who track their cycles, as well as absenteeism from work and education due to PMS or PMDD (D̄=-1.67; t144=-2.49, P=.01). CONCLUSIONS: These pilot randomized controlled trials demonstrate that the use of the Flo app improves menstrual health literacy and awareness, general health and well-being, and PMS or PMDD symptom burden. Considering the widespread use and affordability of the Flo app, these findings show promise for filling important gaps in current health care provisioning such as improving menstrual knowledge and health. TRIAL REGISTRATION: OSF Registries osf.io/pcgw7; https://osf.io/pcgw7 ; OSF Registries osf.io/ry8vq; https://osf.io/ry8vq.

Effects of stress on pain in females using a mobile health app in the Russia-Ukraine conflict.

The chronic and acute effects of stress can have divergent effects on health; long-term effects are associated with detrimental physical and mental health sequelae, while acute effects may be advantageous in the short-term. Stress-induced analgesia, the attenuation of pain perception due to stress, is a well-known phenomenon that has yet to be systematically investigated under ecological conditions. Using Flo, a women's health and wellbeing app and menstrual cycle tracker, with a world-wide monthly active usership of more than 57 million, women in Ukraine were monitored for their reporting of stress, pain and affective symptoms before, and immediately after, the onset of the Russian-Ukrainian conflict. To avoid potential selection (attrition) or collider bias, we rely on a sample of 87,315 users who were actively logging multiple symptoms before and after the start of the war. We found an inverse relationship between stress and pain, whereby higher reports of stress predicted lower rates of pain. Stress did not influence any other physiological symptoms with a similar magnitude, nor did any other symptom have a similar effect on pain. This relationship generally decreased in magnitude in countries neighbouring and surrounding Ukraine, with Ukraine serving as the epicentre. These findings help characterise the relationship between stress and health in a real-world setting.

Heightened interoception in adults with fibromyalgia.

Previous research suggests that the processing of internal body sensations (interoception) affects how we experience pain. Some evidence suggests that people with fibromyalgia syndrome (FMS) - a condition characterised by chronic pain and fatigue - may have altered interoceptive processing. However, extant findings are inconclusive, and some tasks previously used to measure interoception are of questionable validity. Here, we used an alternative measure - the Phase Adjustment Task (PAT) - to examine cardiac interoceptive accuracy in adults with FMS. We examined: (i) the tolerability of the PAT in an FMS sample (N = 154); (ii) if there are differences in facets of interoception (PAT performance, PAT-related confidence, and scores on the Private Body Consciousness Scale) between an FMS sample and an age- and gender-matched pain-free sample (N = 94); and (iii) if subgroups of participants with FMS are identifiable according to interoceptive accuracy levels. We found the PAT was tolerable in the FMS sample, with additional task breaks and a recommended hand posture. The FMS sample were more likely to be classified as 'interoceptive' on the PAT, and had significantly higher self-reported interoception compared to the pain-free sample. Within the FMS sample, we identified a subgroup who demonstrated very strong evidence of being interoceptive, and concurrently had lower fibromyalgia symptom impact (although the effect size was small). Conversely, self-reported interoception was positively correlated with FMS symptom severity and impact. Overall, interoception may be an important factor to consider in understanding and managing FMS symptoms. We recommend future longitudinal work to better understand associations between fluctuating FMS symptoms and interoception.

Examining the role of self-reported somatosensory sensations in body (dis)ownership: A scoping review and empirical study of patients with a disturbed sense of limb ownership.

Patients with a disturbed sense of limb ownership (DSO) offer a unique window of insight into the multisensory processes contributing to the sense of body ownership. A limited amount of past research has examined the role of sensory deficits in DSO, and even less is known regarding the role of patient self-reported somatosensory sensations in the pathogenesis of DSO. To address this lack of knowledge we first conducted a systematic scoping review following PRISMA-SR guidelines, examining current research into somatosensory deficits and patient self-reported somatosensory sensations in patients with DSO. Eighty studies, including 277 DSO patients, were identified. The assessment of sensory deficits was generally limited in scope and quality, and deficits in tactile sensitivity and proprioception were most frequently found. The reporting of somatosensory sensations was even less frequent, with instances of paraesthesia (pins-and-needles), stiffness/rigidity, numbness and warmth, coldness and heaviness amongst the deficits recorded. In a second part of the study, we sought to directly address the lack of evidence concerning the impact of patient self-reported somatosensory sensations in DSO by measuring DSO and self-reported somatosensory sensations in a large (n = 121) sample of right-hemisphere stroke patients including N = 65 with DSO and N = 56 hemiplegic controls. Results show that feelings of coldness and stiffness modulate DSO symptoms. Sense of heaviness and numbness are more frequent in patients with DSO but do not have a clear impact on disownership symptomology. Although preliminary, these results suggest a role of subjective sensations about the felt body in the sense of limb ownership.

Assessment of a Digital Symptom Checker Tool's Accuracy in Suggesting Reproductive Health Conditions: Clinical Vignettes Study.

BACKGROUND: Reproductive health conditions such as endometriosis, uterine fibroids, and polycystic ovary syndrome (PCOS) affect a large proportion of women and people who menstruate worldwide. Prevalence estimates for these conditions range from 5% to 40% of women of reproductive age. Long diagnostic delays, up to 12 years, are common and contribute to health complications and increased health care costs. Symptom checker apps provide users with information and tools to better understand their symptoms and thus have the potential to reduce the time to diagnosis for reproductive health conditions. OBJECTIVE: This study aimed to evaluate the agreement between clinicians and 3 symptom checkers (developed by Flo Health UK Limited) in assessing symptoms of endometriosis, uterine fibroids, and PCOS using vignettes. We also aimed to present a robust example of vignette case creation, review, and classification in the context of predeployment testing and validation of digital health symptom checker tools. METHODS: Independent general practitioners were recruited to create clinical case vignettes of simulated users for the purpose of testing each condition symptom checker; vignettes created for each condition contained a mixture of condition-positive and condition-negative outcomes. A second panel of general practitioners then reviewed, approved, and modified (if necessary) each vignette. A third group of general practitioners reviewed each vignette case and designated a final classification. Vignettes were then entered into the symptom checkers by a fourth, different group of general practitioners. The outcomes of each symptom checker were then compared with the final classification of each vignette to produce accuracy metrics including percent agreement, sensitivity, specificity, positive predictive value, and negative predictive value. RESULTS: A total of 24 cases were created per condition. Overall, exact matches between the vignette general practitioner classification and the symptom checker outcome were 83% (n=20) for endometriosis, 83% (n=20) for uterine fibroids, and 88% (n=21) for PCOS. For each symptom checker, sensitivity was reported as 81.8% for endometriosis, 84.6% for uterine fibroids, and 100% for PCOS; specificity was reported as 84.6% for endometriosis, 81.8% for uterine fibroids, and 75% for PCOS; positive predictive value was reported as 81.8% for endometriosis, 84.6% for uterine fibroids, 80% for PCOS; and negative predictive value was reported as 84.6% for endometriosis, 81.8% for uterine fibroids, and 100% for PCOS. CONCLUSIONS: The single-condition symptom checkers have high levels of agreement with general practitioner classification for endometriosis, uterine fibroids, and PCOS. Given long delays in diagnosis for many reproductive health conditions, which lead to increased medical costs and potential health complications for individuals and health care providers, innovative health apps and symptom checkers hold the potential to improve care pathways.

App Characteristics and Accuracy Metrics of Available Digital Biomarkers for Autism: Scoping Review.

BACKGROUND: Diagnostic delays in autism are common, with the time to diagnosis being up to 3 years from the onset of symptoms. Such delays have a proven detrimental effect on individuals and families going through the process. Digital health products, such as mobile apps, can help close this gap due to their scalability and ease of access. Further, mobile apps offer the opportunity to make the diagnostic process faster and more accurate by providing additional and timely information to clinicians undergoing autism assessments. OBJECTIVE: The aim of this scoping review was to synthesize the available evidence about digital biomarker tools to aid clinicians, researchers in the autism field, and end users in making decisions as to their adoption within clinical and research settings. METHODS: We conducted a structured literature search on databases and search engines to identify peer-reviewed studies and regulatory submissions that describe app characteristics, validation study details, and accuracy and validity metrics of commercial and research digital biomarker apps aimed at aiding the diagnosis of autism. RESULTS: We identified 4 studies evaluating 4 products: 1 commercial and 3 research apps. The accuracy of the identified apps varied between 28% and 80.6%. Sensitivity and specificity also varied, ranging from 51.6% to 81.6% and 18.5% to 80.5%, respectively. Positive predictive value ranged from 20.3% to 76.6%, and negative predictive value fluctuated between 48.7% and 97.4%. Further, we found a lack of details around participants' demographics and, where these were reported, important imbalances in sex and ethnicity in the studies evaluating such products. Finally, evaluation methods as well as accuracy and validity metrics of available tools were not clearly reported in some cases and varied greatly across studies. Different comparators were also used, with some studies validating their tools against the Diagnostic and Statistical Manual of Mental Disorders criteria and others through self-reported measures. Further, while in most cases, 2 classes were used for algorithm validation purposes, 1 of the studies reported a third category (indeterminate). These discrepancies substantially impact the comparability and generalizability of the results, thus highlighting the need for standardized validation processes and the reporting of findings. CONCLUSIONS: Despite their popularity, systematic evaluations and syntheses of the current state of the art of digital health products are lacking. Standardized and transparent evaluations of digital health tools in diverse populations are needed to assess their real-world usability and validity, as well as help researchers, clinicians, and end users safely adopt novel tools within clinical and research practices.

Employees' support strategies for mental wellbeing during and beyond the COVID-19 pandemic: Recommendations for employers in the UK workforce.

Throughout the COVID-19 pandemic, and beyond for many businesses, employees have had to adapt to new ways of working due to disruptions in traditional practices. It is therefore crucial to understand the new challenges that employees are facing when it comes to taking care of their mental wellbeing at work. To that end, we distributed a survey to full-time UK employees (N = 451) to explore how supported they felt throughout the pandemic, and to identify whether there are any additional types of support they would like to receive. We also compared employees' intentions to seek help before versus during the COVID-19 pandemic, and assessed their current attitudes toward mental health. Based on direct employee feedback, our results show remote workers felt more supported throughout the pandemic compared to hybrid workers. We also found that employees who had previously experienced an episode of anxiety or depression were significantly more likely to want extra support at work compared to those who had not. Furthermore, employees were significantly more likely to seek help for their mental health during the pandemic compared to before. Interestingly, the largest increase in intentions to seek help during the pandemic compared to before was with digital health solutions. Finally, we found that the strategies managers have adopted to better support their employees, an employee's mental health history, and their attitude to mental health all contributed to significantly increasing the likelihood that an employee would disclose a mental health concern to their line manager. We provide recommendations that encourage organisations to make changes to better support their employees, and we highlight the importance of mental health awareness training for both managers and employees. This work is of particular interest to organisations who are looking to tailor their current employee wellbeing offer to a post-pandemic world.

Characterization of Self-reported Improvements in Knowledge and Health Among Users of Flo Period Tracking App: Cross-sectional Survey.

BACKGROUND: Research shows that poor knowledge and awareness of menstrual and pregnancy health among women are associated with adverse reproductive health and pregnancy outcomes. Menstrual cycle- and pregnancy-tracking mobile apps are promising tools for improving women's awareness of and attitudes toward their reproductive health; however, there is little information about subscribers' perceptions of app functionality and its impact on their knowledge and health. OBJECTIVE: This study aimed to explore knowledge and health improvements related to menstrual cycle and pregnancy, as well as improvements in general health among Flo app users. We also investigated what components of the Flo app were associated with the abovementioned improvements and evaluated whether those improvements differed based on education level, country of residence (low- and middle-income vs high-income countries), free or premium subscription to the app, short- or long-term use of the app, and frequency of use. METHODS: Flo subscribers who had been using the app for no less than 30 days, completed a web-based survey. A total of 2212 complete survey responses were collected. The survey included demographic questions and questions about motivations guiding the use of the Flo app and which components of the app improved their knowledge and health, as well as to what extent. RESULTS: Most study participants reported improvements in menstrual cycle (1292/1452, 88.98%) and pregnancy (698/824, 84.7%) knowledge from Flo app use. Participants with higher levels of education and those from high-income countries reported using the app predominantly for getting pregnant (χ21=4.2, P=.04; χ21=52.3, P<.001, respectively) and pregnancy tracking (χ21=19.3, P<.001; χ21=20.9, P=.001, respectively). Participants with less education reported using the app to avoid pregnancy (χ21=4.2; P=.04) and to learn more about their body (χ21=10.8; P=.001) and sexual health (χ21=6.3; P=.01), while participants from low- and middle-income countries intended to mainly learn more about their sexual health (χ21=18.2; P<.001). Importantly, the intended use of the app across education levels and country income levels matched areas in which they had gained knowledge and achieved their health goals upon use of the Flo app. Period, fertile days, and ovulation predictions as well as symptom tracking were consistently the top 3 components in the app that helped users with their cycle knowledge and general health. Reading articles or watching videos helped with users' education regarding their pregnancy. Finally, the strongest improvements in knowledge and health were observed in premium, frequent, and long-term users. CONCLUSIONS: This study suggests that menstrual health apps, such as Flo, could present revolutionary tools to promote consumer health education and empowerment on a global scale.

Depersonalization disorder as a systematic downregulation of interoceptive signals.

Depersonalisation disorder (DPD) is a psychopathological condition characterised by a feeling of detachment from one's own body and surrounding, and it is understood as emerging from the downregulation of interoceptive afferents. However, the precise mechanisms that drive this 'interoceptive silencing' are yet to be clarified. Here we present a computational and neurobiologically plausible model of DPD within the active inference framework. Specifically, we describe DPD as arising from disrupted interoceptive processing at higher levels of the cortical hierarchy where the interoceptive and exteroceptive streams are integrated. We simulated the behaviour of an agent subjected to a situation of high interoceptive activation despite the absence of a perceivable threat in the external environment. The simulation showed how a similar condition, if perceived as inescapable, would result in a downregulation of interoceptive signals, whilst leaving the exteroceptive ones unaffected. Such interoceptive silencing would force the agent to over-rely on exteroceptive information and would ultimately lead to the DPD phenomenology. Finally, our simulation shows that repeated exposure to similar situations over time will lead the agent to increasingly disengage from bodily responses even in the face of a less triggering situation, explaining how a single episode of depersonalization can lead to chronic DPD.

Menstrual cycle-associated symptoms and workplace productivity in US employees: A cross-sectional survey of users of the Flo mobile phone app.

Objective: Mood and physical symptoms related to the menstrual cycle affect women's productivity at work, often leading to absenteeism. However, employer-led initiatives to tackle these issues are lacking. Digital health interventions focused on women's health (such as the Flo app) could help fill this gap. Methods: 1867 users of the Flo app participated in a survey exploring the impact of their menstrual cycle on their workplace productivity and the role of Flo in mitigating some of the identified issues. Results: The majority reported a moderate to severe impact of their cycle on workplace productivity, with 45.2% reporting absenteeism (5.8 days on average in the previous 12 months). 48.4% reported not receiving any support from their manager and 94.6% said they were not provided with any specific benefit for issues related to their menstrual cycle, with 75.6% declaring wanting them. Users stated that the Flo app helped them with the management of menstrual cycle symptoms (68.7%), preparedness and bodily awareness (88.7%), openness with others (52.5%), and feeling supported (77.6%). Users who reported the most positive impact of the Flo app were 18-25% less likely to report an impact of their menstrual cycle on their productivity and 12-18% less likely to take days off work for issues related to their cycle. Conclusions: Apps such as Flo could equip individuals with tools to better cope with issues related to their menstrual cycle and facilitate discussions around menstrual health in the workplace.

Measuring Interoception: The CARdiac Elevation Detection Task.

Interoception has increasingly been the focus of psychiatric research, due to its hypothesized role in mental health. Existing interoceptive tasks either suffer from important methodological limitations, impacting their validity, or are burdensome and require specialized equipment, which limits their usage in vulnerable populations. We report on the development of the CARdiac Elevation Detection (CARED) task. Participants' heart rate is recorded by a wearable device connected to a mobile application. Notifications are sent to participants' mobile throughout the day over a period of 4 weeks. Participants are asked to state whether their heart rate is higher than usual, rate their confidence and describe the activity they were involved in when the notification occurred. Data (N = 30) revealed that 1/3 of the sample was classified as interoceptive and that participants presented overall good insight into their interoceptive abilities. Given its ease of administration and accessibility, the CARED task has the potential to be a significant asset for psychiatric and developmental research.

Development of Digitally Obtainable 10-Year Risk Scores for Depression and Anxiety in the General Population.

The burden of depression and anxiety in the world is rising. Identification of individuals at increased risk of developing these conditions would help to target them for prevention and ultimately reduce the healthcare burden. We developed a 10-year predictive algorithm for depression and anxiety using the full cohort of over 400,000 UK Biobank (UKB) participants without pre-existing depression or anxiety using digitally obtainable information. From the initial 167 variables selected from UKB, processed into 429 features, iterative backward elimination using Cox proportional hazards model was performed to select predictors which account for the majority of its predictive capability. Baseline and reduced models were then trained for depression and anxiety using both Cox and DeepSurv, a deep neural network approach to survival analysis. The baseline Cox model achieved concordance of 0.7772 and 0.7720 on the validation dataset for depression and anxiety, respectively. For the DeepSurv model, respective concordance indices were 0.7810 and 0.7728. After feature selection, the depression model contained 39 predictors and the concordance index was 0.7769 for Cox and 0.7772 for DeepSurv. The reduced anxiety model, with 53 predictors, achieved concordance of 0.7699 for Cox and 0.7710 for DeepSurv. The final models showed good discrimination and calibration in the test datasets. We developed predictive risk scores with high discrimination for depression and anxiety using the UKB cohort, incorporating predictors which are easily obtainable via smartphone. If deployed in a digital solution, it would allow individuals to track their risk, as well as provide some pointers to how to decrease it through lifestyle changes.

Implementation of a mHealth solution to remotely monitor patients on a cardiac surgical waiting list: service evaluation.

BACKGROUND: The emergence of COVID-19 resulted in postponement of nonemergent surgical procedures for cardiac patients in London. mHealth represented a potentially viable mechanism for highlighting deteriorating patients on the lengthened cardiac surgical waiting lists. OBJECTIVE: To evaluate the deployment of a digital health solution to support continuous triaging of patients on a cardiac surgical waiting list. METHOD: An NHS trust utilized an app-based mHealth solution (Huma Therapeutics) to help gather vital information on patients awaiting cardiac surgery (valvular and coronary surgery). Patients at a tertiary cardiac center on a waiting list for elective surgery were given the option to be monitored remotely via a mobile app until their date of surgery. Patients were asked to enter their symptoms once a week. The clinical team monitored this information remotely, prompting intervention for those patients who needed it. RESULTS: Five hundred and twenty-five patients were on boarded onto the app. Of the 525 patients using the solution, 51 (9.71%) were identified as at risk of deteriorating based on data captured via the remote patient monitoring platform and subsequently escalated to their respective consultant. 81.7% of patients input at least one symptom after they were on boarded on the platform. DISCUSSION: Although not a generalizable study, this change in practice clearly demonstrates the feasibility and potential benefit digital remote patient monitoring can have in triaging large surgical wait lists, ensuring those that need care urgently receive it. We recommend further study into the potential beneficial outcomes from preoperative cardiac mHealth solutions.

Population risk factors for severe disease and mortality in COVID-19: A global systematic review and meta-analysis.

AIM: COVID-19 clinical presentation is heterogeneous, ranging from asymptomatic to severe cases. While there are a number of early publications relating to risk factors for COVID-19 infection, low sample size and heterogeneity in study design impacted consolidation of early findings. There is a pressing need to identify the factors which predispose patients to severe cases of COVID-19. For rapid and widespread risk stratification, these factors should be easily obtainable, inexpensive, and avoid invasive clinical procedures. The aim of our study is to fill this knowledge gap by systematically mapping all the available evidence on the association of various clinical, demographic, and lifestyle variables with the risk of specific adverse outcomes in patients with COVID-19. METHODS: The systematic review was conducted using standardized methodology, searching two electronic databases (PubMed and SCOPUS) for relevant literature published between 1st January 2020 and 9th July 2020. Included studies reported characteristics of patients with COVID-19 while reporting outcomes relating to disease severity. In the case of sufficient comparable data, meta-analyses were conducted to estimate risk of each variable. RESULTS: Seventy-six studies were identified, with a total of 17,860,001 patients across 14 countries. The studies were highly heterogeneous in terms of the sample under study, outcomes, and risk measures reported. A large number of risk factors were presented for COVID-19. Commonly reported variables for adverse outcome from COVID-19 comprised patient characteristics, including age >75 (OR: 2.65, 95% CI: 1.81-3.90), male sex (OR: 2.05, 95% CI: 1.39-3.04) and severe obesity (OR: 2.57, 95% CI: 1.31-5.05). Active cancer (OR: 1.46, 95% CI: 1.04-2.04) was associated with increased risk of severe outcome. A number of common symptoms and vital measures (respiratory rate and SpO2) also suggested elevated risk profiles. CONCLUSIONS: Based on the findings of this study, a range of easily assessed parameters are valuable to predict elevated risk of severe illness and mortality as a result of COVID-19, including patient characteristics and detailed comorbidities, alongside the novel inclusion of real-time symptoms and vital measurements.

Development and Validation of Risk Scores for All-Cause Mortality for a Smartphone-Based "General Health Score" App: Prospective Cohort Study Using the UK Biobank.

BACKGROUND: Given the established links between an individual's behaviors and lifestyle factors and potentially adverse health outcomes, univariate or simple multivariate health metrics and scores have been developed to quantify general health at a given point in time and estimate risk of negative future outcomes. However, these health metrics may be challenging for widespread use and are unlikely to be successful at capturing the broader determinants of health in the general population. Hence, there is a need for a multidimensional yet widely employable and accessible way to obtain a comprehensive health metric. OBJECTIVE: The objective of the study was to develop and validate a novel, easily interpretable, points-based health score ("C-Score") derived from metrics measurable using smartphone components and iterations thereof that utilize statistical modeling and machine learning (ML) approaches. METHODS: A literature review was conducted to identify relevant predictor variables for inclusion in the first iteration of a points-based model. This was followed by a prospective cohort study in a UK Biobank population for the purposes of validating the C-Score and developing and comparatively validating variations of the score using statistical and ML models to assess the balance between expediency and ease of interpretability and model complexity. Primary and secondary outcome measures were discrimination of a points-based score for all-cause mortality within 10 years (Harrell c-statistic) and discrimination and calibration of Cox proportional hazards models and ML models that incorporate C-Score values (or raw data inputs) and other predictors to predict the risk of all-cause mortality within 10 years. RESULTS: The study cohort comprised 420,560 individuals. During a cohort follow-up of 4,526,452 person-years, there were 16,188 deaths from any cause (3.85%). The points-based model had good discrimination (c-statistic=0.66). There was a 31% relative reduction in risk of all-cause mortality per decile of increasing C-Score (hazard ratio of 0.69, 95% CI 0.663-0.675). A Cox model integrating age and C-Score had improved discrimination (8 percentage points; c-statistic=0.74) and good calibration. ML approaches did not offer improved discrimination over statistical modeling. CONCLUSIONS: The novel health metric ("C-Score") has good predictive capabilities for all-cause mortality within 10 years. Embedding the C-Score within a smartphone app may represent a useful tool for democratized, individualized health risk prediction. A simple Cox model using C-Score and age balances parsimony and accuracy of risk predictions and could be used to produce absolute risk estimations for app users.

Development and Feasibility of a Digital Acceptance and Commitment Therapy-Based Intervention for Generalized Anxiety Disorder: Pilot Acceptability Study.

BACKGROUND: Generalized anxiety disorder (GAD) is characterized by excessive worry that is difficult to control and has high comorbidity with mood disorders including depression. Individuals experience long wait times for diagnosis and often face accessibility barriers to treatment. There is a need for a digital solution that is accessible and acceptable to those with GAD. OBJECTIVE: This paper aims to describe the development of a digital intervention prototype of acceptance and commitment therapy (ACT) for GAD that sits within an existing well-being app platform, BioBase. A pilot feasibility study evaluating acceptability and usability is conducted in a sample of adults with a diagnosis of GAD, self-referred to the study. METHODS: Phase 1 applied the person-based approach (creation of guiding principles, intervention design objectives, and the key intervention features). In Phase 2 participants received the app-based therapeutic and paired wearable for 2 weeks. Self-report questionnaires were obtained at baseline and posttreatment. The primary outcome was psychological flexibility (Acceptance and Action Questionnaire-II [AAQ-II]) as this is the aim of ACT. Mental well-being (Warwick-Edinburgh Mental Well-being Scale [WEMWBS]) and symptoms of anxiety (7-item Generalized Anxiety Disorder Assessment [GAD-7]) and depression (9-item Patient Health Questionnaire [PHQ-9]) were also assessed. Posttreatment usability was assessed via self-report measures (System Usability Scale [SUS]) in addition to interviews that further explored feasibility of the digital intervention in this sample. RESULTS: The app-based therapeutic was well received. Of 13 participants, 10 (77%) completed the treatment. Results show a high usability rating (83.5). Participants found the digital intervention to be relevant, useful, and helpful in managing their anxiety. Participants had lower anxiety (d=0.69) and depression (d=0.84) scores at exit, and these differences were significantly different from baseline (P=.03 and .008 for GAD-7 and PHQ-9, respectively). Participants had higher psychological flexibility and well-being scores at exit, although these were not significantly different from baseline (P=.11 and .55 for AAQ-II and WEMWBS, respectively). CONCLUSIONS: This ACT prototype within BioBase is an acceptable and feasible digital intervention in reducing symptoms of anxiety and depression. This study suggests that this intervention warrants a larger feasibility study in adults with GAD.

The Motor Unawareness Assessment (MUNA): A new tool for the assessment of Anosognosia for hemiplegia.

Introduction: Anosognosia for hemiplegia (AHP) is a condition in which patients with paralysis are unaware of their motor deficits. Research into AHP is important for improving its treatment and providing insight into the neurocognitive mechanism of motor awareness. Unfortunately, most studies use assessments with widely recognized limitations.The study aims at developing a psychometrically validated assessment of AHP.Method: We developed a 40-item Motor Unawareness Assessment (MUNA) and administered it to 131 right-hemisphere stroke patients. Principal Component Analysis (PCA) was used to identify the underlying factor structure. Receiver Operating Characteristics (ROC) analysis was used to determine diagnostic cutoffs, and Area Under the Curve (AUC) analysis used to assess these cutoffs. Relationships with demographic, clinical and neuropsychological variables were explored.Results: Five factors were identified: explicit motor awareness, implicit motor awareness, impaired sense of ownership, agency and illusory movement, and emotional reactions. Established cutoffs had excellent sensitivity and specificity. Clinical, neuropsychological and demographic variables did not predict overall MUNA score but were related to specific subcomponents.Conclusion: The MUNA can differentiate various facets of AHP and provides a detailed profile of (un)awareness. The MUNA can therefore provide robust assessment for research purposes and assist clinicians when developing targeted rehabilitation.

"Dance Like Nobody's Watching": Exploring the Role of Dance-Based Interventions in Perceived Well-Being and Bodily Awareness in People With Parkinson's.

Evidence indicates that bodily perception is negatively related to Parkinson's disease (PD); in particular, people with Parkinson's (PwP) feel dissatisfaction in their physical abilities and appearance. While established treatments exist to ameliorate motor symptoms in PD, research has yet to explore the effects of well-being-focused interventions in relation to the subjective experience of bodily concerns of PwP. This mixed methods exploratory study investigated the constructs of body appreciation in relation to well-being in PwP and the impact of participation in a dance class on body appreciation and well-being, comparing PwP with age-matched controls. Participants (n = 27 PwP, n = 14 controls) completed the Warwick Edinburgh Mental Well-Being Scale and the Body Appreciation Scale before and after taking part in a dance class. Well-being was positively associated with body appreciation in PwP (r s = 0.64, p < 0.001) but not in controls. Following participation in a dance class, all participants' well-being scores increased; a greater increase in well-being scores was observed for controls. A pilot qualitative study explored bodily awareness with PwP who attended dance classes (n = 4) and other movement-based activities (n = 4). Analysis of the interview data indicated that PwP who danced showed heightened bodily awareness, including bodily limitations, in comparison with PwP who did not dance. These preliminary findings provide initial insight explaining the lack of improvements in body appreciation in PwP following a dance class. The current study highlights the need for dance interventions for PwP to consider incorporating elements that encourage a body positive attitude alongside fostering perceived well-being.

Exploring the Effects of a Brief Biofeedback Breathing Session Delivered Through the BioBase App in Facilitating Employee Stress Recovery: Randomized Experimental Study.

BACKGROUND: Recovery from stress is a predictive factor for cardiovascular health, and heart rate variability (HRV) is suggested to be an index of how well people physiologically recover from stress. Biofeedback and mindfulness interventions that include guided breathing have been shown to be effective in increasing HRV and facilitating stress recovery. OBJECTIVE: This study aims to assess the effectiveness of a brief app-based breathing intervention (BioBase) in enhancing physiological recovery among employees who were induced to cognitive and emotional stress. METHODS: In total, we recruited 75 full-time employees. Interbeat (RR) intervals were recorded continuously for 5 min at baseline and during cognitive and emotional stress induction. The session ended with a 5-min recovery period during which participants were randomly allocated into 3 conditions: app-based breathing (BioBase), mindfulness body scan, or control. Subjective tension was assessed at the end of each period. RESULTS: Subjective tension significantly increased following stress induction. HRV significantly decreased following the stress period. In the recovery phase, the root mean square of successive RR interval differences (P=.002), the percentage of successive RR intervals that differed by >50 ms (P=.008), and high frequency (P=.01) were significantly higher in the BioBase breathing condition than in the mindfulness body scan and the control groups. CONCLUSIONS: Biofeedback breathing interventions digitally delivered through a commercially available app can be effective in facilitating stress recovery among employees. These findings contribute to the mobile health literature on the beneficial effects of brief app-based breathing interventions on employees' cardiovascular health.

Effectiveness of a Smartphone App (BioBase) for Reducing Anxiety and Increasing Mental Well-Being: Pilot Feasibility and Acceptability Study.

BACKGROUND: The prevalence of workplace-related stress and anxiety is high, resulting in stress-related physical and mental illness. Digital self-guided interventions aimed at key areas of workplace design may be able to provide remote anxiolytic effects. OBJECTIVE: The aim of this feasibility study is to assess changes in anxiety and mental well-being after use of the BioBase programme, a mobile phone platform for psycho-educational modules, tools, and real-time feedback of physiological data. METHODS: A 4-week observational study was carried out in 55 healthy adults who were screened for stress with the Depression Anxiety Stress Scale (DASS) Stress subscale. Participants completed anxiety (6-item State-Trait Anxiety Inventory [STAI]) and mental well-being (Warwick-Edinburgh Mental Well-being Scale [WEMWBS]) questionnaires at baseline and at 4 weeks. Feedback questionnaires were administered after 4 weeks. RESULTS: After 4 weeks of using the programme and controlling for any effect of being paid to take part in the study, STAI significantly decreased (baseline mean 45.52 [SD 13.2]; 4-week mean 39.82 [SD 11.2]; t54=-3.51; P<.001; CI -8.88 to -2.52; Cohen d=0.96) and WEMWBS significantly increased (baseline mean 48.12 [SD 6.4]; 4-week mean 50.4 [SD 6.9]; t53=2.41; P=.019; CI 0.44-4.23; Cohen d=0.66). Further, higher baseline stress was significantly associated with a greater decrease in STAI (t53=-3.41; P=.001; CI -8.10 to -2.10; R2=0.180) and a greater increase in WEMWBS (t52=2.41; P=.019; CI 0.38-4.11, R2=0.101). On feedback, participants found the programme easy to use/navigate, with the content being acceptable and relevant to workplace-related stressors; 70% (21/30) of participants would recommend the programme to a friend. CONCLUSIONS: The BioBase programme is a potentially effective intervention in decreasing anxiety and increasing mental well-being, with larger changes in those with higher baseline levels of stress.