RESUMO
BACKGROUND: Suboptimal adherence to data collection procedures or a study intervention is often the cause of a failed clinical trial. Data from connected sensors, including wearables, referred to here as biometric monitoring technologies (BioMeTs), are capable of capturing adherence to both digital therapeutics and digital data collection procedures, thereby providing the opportunity to identify the determinants of adherence and thereafter, methods to maximize adherence. OBJECTIVE: We aim to describe the methods and definitions by which adherence has been captured and reported using BioMeTs in recent years. Identifying key gaps allowed us to make recommendations regarding minimum reporting requirements and consistency of definitions for BioMeT-based adherence data. METHODS: We conducted a systematic review of studies published between 2014 and 2019, which deployed a BioMeT outside the clinical or laboratory setting for which a quantitative, nonsurrogate, sensor-based measurement of adherence was reported. After systematically screening the manuscripts for eligibility, we extracted details regarding study design, participants, the BioMeT or BioMeTs used, and the definition and units of adherence. The primary definitions of adherence were categorized as a continuous variable based on duration (highest resolution), a continuous variable based on the number of measurements completed, or a categorical variable (lowest resolution). RESULTS: Our PubMed search terms identified 940 manuscripts; 100 (10.6%) met our eligibility criteria and contained descriptions of 110 BioMeTs. During literature screening, we found that 30% (53/177) of the studies that used a BioMeT outside of the clinical or laboratory setting failed to report a sensor-based, nonsurrogate, quantitative measurement of adherence. We identified 37 unique definitions of adherence reported for the 110 BioMeTs and observed that uniformity of adherence definitions was associated with the resolution of the data reported. When adherence was reported as a continuous time-based variable, the same definition of adherence was adopted for 92% (46/50) of the tools. However, when adherence data were simplified to a categorical variable, we observed 25 unique definitions of adherence reported for 37 tools. CONCLUSIONS: We recommend that quantitative, nonsurrogate, sensor-based adherence data be reported for all BioMeTs when feasible; a clear description of the sensor or sensors used to capture adherence data, the algorithm or algorithms that convert sample-level measurements to a metric of adherence, and the analytic validation data demonstrating that BioMeT-generated adherence is an accurate and reliable measurement of actual use be provided when available; and primary adherence data be reported as a continuous variable followed by categorical definitions if needed, and that the categories adopted are supported by clinical validation data and/or consistent with previous reports.
Assuntos
Biometria , Cimetidina , Biometria/métodos , Coleta de Dados , Humanos , Projetos de Pesquisa , TecnologiaRESUMO
BACKGROUND: Despite decades of research to better understand suicide risk and to develop detection and prevention methods, suicide is still one of the leading causes of death globally. While large-scale studies using real-world evidence from electronic health records can identify who is at risk, they have not been successful at pinpointing when someone is at risk. Personalized social media and online search history data, by contrast, could provide an ongoing real-world datastream revealing internal thoughts and personal states of mind. OBJECTIVE: We conducted this study to determine the feasibility and acceptability of using personalized online information-seeking behavior in the identification of risk for suicide attempts. METHODS: This was a cohort survey study to assess attitudes of participants with a prior suicide attempt about using web search data for suicide prevention purposes, dates of lifetime suicide attempts, and an optional one-time download of their past web searches on Google. The study was conducted at the University of Washington School of Medicine Psychiatry Research Offices. The main outcomes were participants' opinions on internet search data for suicide prediction and intervention and any potential change in online information-seeking behavior proximal to a suicide attempt. Individualized nonparametric association analysis was used to assess the magnitude of difference in web search data features derived from time periods proximal (7, 15, 30, and 60 days) to the suicide attempts versus the typical (baseline) search behavior of participants. RESULTS: A total of 62 participants who had attempted suicide in the past agreed to participate in the study. Internet search activity varied from person to person (median 2-24 searches per day). Changes in online search behavior proximal to suicide attempts were evident up to 60 days before attempt. For a subset of attempts (7/30, 23%) search features showed associations from 2 months to a week before the attempt. The top 3 search constructs associated with attempts were online searching patterns (9/30 attempts, 30%), semantic relatedness of search queries to suicide methods (7/30 attempts, 23%), and anger (7/30 attempts, 23%). Participants (40/59, 68%) indicated that use of this personalized web search data for prevention purposes was acceptable with noninvasive potential interventions such as connection to a real person (eg, friend, family member, or counselor); however, concerns were raised about detection accuracy, privacy, and the potential for overly invasive intervention. CONCLUSIONS: Changes in online search behavior may be a useful and acceptable means of detecting suicide risk. Personalized analysis of online information-seeking behavior showed notable changes in search behavior and search terms that are tied to early warning signs of suicide and are evident 2 months to 7 days before a suicide attempt.
Assuntos
Ferramenta de Busca , Tentativa de Suicídio , Estudos de Coortes , Humanos , Comportamento de Busca de Informação , Internet , Projetos PilotoRESUMO
BACKGROUND: Smartphones provide a low-cost and efficient means to collect population level data. Several small studies have shown promise in predicting mood variability from smartphone-based sensor and usage data, but have not been generalized to nationally recruited samples. This study used passive smartphone data, demographic characteristics, and baseline depressive symptoms to predict prospective daily mood. METHOD: Daily phone usage data were collected passively from 271 Android phone users participating in a fully remote randomized controlled trial of depression treatment (BRIGHTEN). Participants completed daily Patient Health Questionnaire-2. A machine learning approach was used to predict daily mood for the entire sample and individual participants. RESULTS: Sample-wide estimates showed a marginally significant association between physical mobility and self-reported daily mood (B = -0.04, P < 0.05), but the predictive models performed poorly for the sample as a whole (median R2 â¼ 0). Focusing on individuals, 13.9% of participants showed significant association (FDR < 0.10) between a passive feature and daily mood. Personalized models combining features provided better prediction performance (median area under the curve [AUC] > 0.50) for 80.6% of participants and very strong prediction in a subset (median AUC > 0.80) for 11.8% of participants. CONCLUSIONS: Passive smartphone data with current features may not be suited for predicting daily mood at a population level because of the high degree of intra- and interindividual variation in phone usage patterns and daily mood ratings. Personalized models show encouraging early signs for predicting an individual's mood state changes, with GPS-derived mobility being the top most important feature in the present sample.
Assuntos
Afeto , Smartphone/estatística & dados numéricos , Adulto , Depressão/diagnóstico , Depressão/psicologia , Depressão/terapia , Feminino , Humanos , Masculino , Estudos Prospectivos , Reprodutibilidade dos Testes , AutorrelatoRESUMO
With over 10,000 mental health- and psychiatry-related smartphone apps available today and expanding, there is a need for reliable and valid evaluation of these digital tools. However, the updating and nonstatic nature of smartphone apps, expanding privacy concerns, varying degrees of usability, and evolving interoperability standards, among other factors, present serious challenges for app evaluation. In this article, we provide a narrative review of various schemes toward app evaluations, including commercial app store metrics, government initiatives, patient-centric approaches, point-based scoring, academic platforms, and expert review systems. We demonstrate that these different approaches toward app evaluation each offer unique benefits but often do not agree to each other and produce varied conclusions as to which apps are useful or not. Although there are no simple solutions, we briefly introduce a new initiative that aims to unify the current controversies in app elevation called CHART (Collaborative Health App Rating Teams), which will be further discussed in a second article in this series.
Assuntos
Atenção à Saúde , Saúde Mental , Aplicativos Móveis , Telemedicina , Consenso , HumanosRESUMO
BACKGROUND: Most people with mental health disorders fail to receive timely access to adequate care. US Hispanic/Latino individuals are particularly underrepresented in mental health care and are historically a very difficult population to recruit into clinical trials; however, they have increasing access to mobile technology, with over 75% owning a smartphone. This technology has the potential to overcome known barriers to accessing and utilizing traditional assessment and treatment approaches. OBJECTIVE: This study aimed to compare recruitment and engagement in a fully remote trial of individuals with depression who either self-identify as Hispanic/Latino or not. A secondary aim was to assess treatment outcomes in these individuals using three different self-guided mobile apps: iPST (based on evidence-based therapeutic principles from problem-solving therapy, PST), Project Evolution (EVO; a cognitive training app based on cognitive neuroscience principles), and health tips (a health information app that served as an information control). METHODS: We recruited Spanish and English speaking participants through social media platforms, internet-based advertisements, and traditional fliers in select locations in each state across the United States. Assessment and self-guided treatment was conducted on each participant's smartphone or tablet. We enrolled 389 Hispanic/Latino and 637 non-Hispanic/Latino adults with mild to moderate depression as determined by Patient Health Questionnaire-9 (PHQ-9) score≥5 or related functional impairment. Participants were first asked about their preferences among the three apps and then randomized to their top two choices. Outcomes were depressive symptom severity (measured using PHQ-9) and functional impairment (assessed with Sheehan Disability Scale), collected over 3 months. Engagement in the study was assessed based on the number of times participants completed active surveys. RESULTS: We screened 4502 participants and enrolled 1040 participants from throughout the United States over 6 months, yielding a sample of 348 active users. Long-term engagement surfaced as a key issue among Hispanic/Latino participants, who dropped from the study 2 weeks earlier than their non-Hispanic/Latino counterparts (P<.02). No significant differences were observed for treatment outcomes between those identifying as Hispanic/Latino or not. Although depressive symptoms improved (beta=-2.66, P=.006) over the treatment course, outcomes did not vary by treatment app. CONCLUSIONS: Fully remote mobile-based studies can attract a diverse participant pool including people from traditionally underserved communities in mental health care and research (here, Hispanic/Latino individuals). However, keeping participants engaged in this type of "low-touch" research study remains challenging. Hispanic/Latino populations may be less willing to use mobile apps for assessing and managing depression. Future research endeavors should use a user-centered design to determine the role of mobile apps in the assessment and treatment of depression for this population, app features they would be interested in using, and strategies for long-term engagement. TRIAL REGISTRATION: Clinicaltrials.gov NCT01808976; https://clinicaltrials.gov/ct2/show/NCT01808976 (Archived by WebCite at http://www.webcitation.org/70xI3ILkz).
Assuntos
Depressão/terapia , Aplicativos Móveis/tendências , Psicoterapia/métodos , Adulto , Depressão/patologia , Hispânico ou Latino , Humanos , Resultado do Tratamento , Adulto JovemRESUMO
Digital therapeutics-web-based programs, smartphone applications, and wearable devices designed to prevent, treat, or manage clinical conditions through software-driven, evidence-based intervention-can provide accessible alternatives and/or may supplement standard care for patients with serious mental illnesses, including schizophrenia. In this article, we provide a targeted summary of the rapidly growing field of digital therapeutics for schizophrenia and related serious mental illnesses. First, we define digital therapeutics. Then, we provide a brief summary of the emerging evidence of the efficacy of digital therapeutics for improving clinical outcomes, focusing on potential mechanisms of action for addressing some of the most challenging problems, including negative symptoms of psychosis. Our focus on these promising targets for digital therapeutics, including the latest in prescription models in the commercial space, highlights future directions for research and practice in this exciting field.
RESUMO
Phyllanthus emblica, popularly mentioned as amla or Indian gooseberry, has attracted a lot of interest lately because of its varied phytochemical makeup and related pharmacological properties. The phytochemistry, historical applications, bioactive makeup, and pharmacological properties of Phyllanthus emblica fruits are all summarised in this paper. This review emphasises the rich phytochemical profile of Phyllanthus emblica, which contains flavonoids, tannins, alkaloids, and polyphenolic chemicals, through a thorough assessment of the literature. Furthermore, the historical value of Phyllanthus emblica as a therapeutic agent for a variety of health issues is shown by its traditional applications in numerous indigenous medical systems. The bioactive makeup of Phyllanthus emblica fruits, especially its high polyphenol and vitamin C content, is responsible for its hepatoprotective, antioxidant, and anti-inflammatory qualities. Moreover, new pharmacological research has clarified its potential for the cure of neurological illnesses, tumor, diabetes, and cardiovascular diseases. In order to shed light on the pharmacological properties of Phyllanthus emblica fruits and suggest future avenues for study, this review compiles the body of scientific data that is already accessible. All things considered, Phyllanthus Emblica shows great promise as a natural resource with significant applications in complementary and alternative medicine and pharmacological research.
RESUMO
Bipolar disorder (BD) is a mood disorder with different phases alternating between euthymia, manic or hypomanic episodes, and depressive episodes. While motor abnormalities are commonly seen during depressive or manic episodes, not much attention has been paid to postural abnormalities during periods of euthymia and their association with illness burden. We collected 24-hour posture data in 32 euthymic participants diagnosed with BD using a shirt-based wearable. We extracted a set of nine time-domain features, and performed unsupervised participant clustering. We investigated the association between posture variables and 12 clinical characteristics of illness burden. Based on their postural dynamics during the daytime, evening, or nighttime, participants clustered in three clusters. Higher illness burden was associated with lower postural variability, in particular during daytime. Participants who exhibited a mostly upright sitting/standing posture during the night with frequent nighttime postural transitions had the highest number of lifetime depressive episodes. Euthymic participants with BD exhibit postural abnormalities that are associated with illness burden, especially with the number of depressive episodes. Our results contribute to understanding the role of illness burden on posture changes and sleep consolidation in periods of euthymia.
Assuntos
Transtorno Bipolar , Postura , Aprendizado de Máquina não Supervisionado , Humanos , Transtorno Bipolar/fisiopatologia , Masculino , Feminino , Adulto , Postura/fisiologia , Pessoa de Meia-Idade , Dispositivos Eletrônicos Vestíveis , Processamento de Sinais Assistido por Computador , Adulto JovemRESUMO
Real-world data (RWD) like electronic health records (EHR) has great potential for secondary use by health systems and researchers. However, collected primarily for efficient health care, EHR data may not equitably represent local regions and populations, impacting the generalizability of insights learned from it. We assessed the geospatial representativeness of regions in a large health system EHR data using a spatial analysis workflow, which provides a data-driven way to quantify geospatial representation and identify adequately represented regions. We applied the workflow to investigate geospatial patterns of overweight/obesity and depression patients to find regional "hotspots" for potential targeted interventions. Our findings show the presence of geospatial bias in EHR and demonstrate the workflow to identify spatial clusters after adjusting for bias due to the geospatial representativeness. This work highlights the importance of evaluating geospatial representativeness in RWD to guide targeted deployment of limited healthcare resources and generate equitable real-world evidence.
RESUMO
Importance: The use of consumer-grade wearable devices for collecting data for biomedical research may be associated with social determinants of health (SDoHs) linked to people's understanding of and willingness to join and remain engaged in remote health studies. Objective: To examine whether demographic and socioeconomic indicators are associated with willingness to join a wearable device study and adherence to wearable data collection in children. Design, Setting, and Participants: This cohort study used wearable device usage data collected from 10â¯414 participants (aged 11-13 years) at the year-2 follow-up (2018-2020) of the ongoing Adolescent Brain and Cognitive Development (ABCD) Study, performed at 21 sites across the United States. Data were analyzed from November 2021 to July 2022. Main Outcomes and Measures: The 2 primary outcomes were (1) participant retention in the wearable device substudy and (2) total device wear time during the 21-day observation period. Associations between the primary end points and sociodemographic and economic indicators were examined. Results: The mean (SD) age of the 10â¯414 participants was 12.00 (0.72) years, with 5444 (52.3%) male participants. Overall, 1424 participants (13.7%) were Black; 2048 (19.7%), Hispanic; and 5615 (53.9%) White. Substantial differences were observed between the cohort that participated and shared wearable device data (wearable device cohort [WDC]; 7424 participants [71.3%]) compared with those who did not participate or share data (no wearable device cohort [NWDC]; 2900 participants [28.7%]). Black children were significantly underrepresented (-59%) in the WDC (847 [11.4%]) compared with the NWDC (577 [19.3%]; P < .001). In contrast, White children were overrepresented (+132%) in the WDC (4301 [57.9%]) vs the NWDC (1314 [43.9%]; P < .001). Children from low-income households (<$24â¯999) were significantly underrepresented in WDC (638 [8.6%]) compared with NWDC (492 [16.5%]; P < .001). Overall, Black children were retained for a substantially shorter duration (16 days; 95% CI, 14-17 days) compared with White children (21 days; 95% CI, 21-21 days; P < .001) in the wearable device substudy. In addition, total device wear time during the observation was notably different between Black vs White children (ß = -43.00 hours; 95% CI, -55.11 to -30.88 hours; P < .001). Conclusions and Relevance: In this cohort study, large-scale wearable device data collected from children showed considerable differences between White and Black children in terms of enrollment and daily wear time. While wearable devices provide an opportunity for real-time, high-frequency contextual monitoring of individuals' health, future studies should account for and address considerable representational bias in wearable data collection associated with demographic and SDoH factors.
Assuntos
Dispositivos Eletrônicos Vestíveis , Adolescente , Humanos , Masculino , Criança , Estados Unidos , Feminino , Estudos de Coortes , Fatores Socioeconômicos , Estudos Longitudinais , DemografiaRESUMO
Objective: Recruitment of a sufficiently large and representative patient sample and its retention during central nervous system (CNS) trials presents major challenges for study sponsors. Technological advances are reshaping clinical trial operations to meet these challenges, and the COVID-19 pandemic further accelerated this development. Method of Research: The International Society for CNS Clinical Trials and Methodology (ISCTM; www.isctm.org) Innovative Technologies for CNS Trials Working Group surveyed the state of technological innovations for improved recruitment and retention and assessed their promises and pitfalls. Results: Online advertisement and electronic patient registries can enhance recruitment, but challenges with sample representativeness, conversion rates from eligible prescreening to enrolled patients, data privacy and security, and patient identification remain hurdles for optimal use of these technologies. Electronic medical records (EMR) mining with artificial intelligence (AI)/machine learning (ML) methods is promising but awaits translation into trials. During the study treatment phase, technological innovations increasingly support participant retention, including adherence with the investigational treatment. Digital tools for adherence and retention support take many forms, including patient-centric communication channels between researchers and participants, real-time study reminders, and digital behavioral interventions to increase study compliance. However, such tools add technical complexities to trials, and their impact on the generalizability of results are largely unknown. Conclusion: Overall, the group found a scarcity of systematic data directly assessing the impact of technological innovations on study recruitment and retention in CNS trials, even for strategies with already high adoption, such as online recruitment. Given the added complexity and costs associated with most technological innovations, such data is needed to fully harness technologies for CNS trials and drive further adoption.
RESUMO
Recent growth in digital technologies has enabled the recruitment and monitoring of large and diverse populations in remote health studies. However, the generalizability of inference drawn from remotely collected health data could be severely impacted by uneven participant engagement and attrition over the course of the study. We report findings on long-term participant retention and engagement patterns in a large multinational observational digital study for depression containing active (surveys) and passive sensor data collected via Android smartphones, and Fitbit devices from 614 participants for up to 2 years. Majority of participants (67.6%) continued to remain engaged in the study after 43 weeks. Unsupervised clustering of participants' study apps and Fitbit usage data showed 3 distinct engagement subgroups for each data stream. We found: (i) the least engaged group had the highest depression severity (4 PHQ8 points higher) across all data streams; (ii) the least engaged group (completed 4 bi-weekly surveys) took significantly longer to respond to survey notifications (3.8 h more) and were 5 years younger compared to the most engaged group (completed 20 bi-weekly surveys); and (iii) a considerable proportion (44.6%) of the participants who stopped completing surveys after 8 weeks continued to share passive Fitbit data for significantly longer (average 42 weeks). Additionally, multivariate survival models showed participants' age, ownership and brand of smartphones, and recruitment sites to be associated with retention in the study. Together these findings could inform the design of future digital health studies to enable equitable and balanced data collection from diverse populations.
RESUMO
Neurotrophin-dependent activation of the tyrosine kinase receptor trkB.FL modulates neuromuscular synapse maintenance and function; however, it is unclear what role the alternative splice variant, truncated trkB (trkB.T1), may have in the peripheral neuromuscular axis. We examined this question in trkB.T1 null mice and demonstrate that in vivo neuromuscular performance and nerve-evoked muscle tension are significantly increased. In vitro assays indicated that the gain-in-function in trkB.T1(-/-) animals resulted specifically from an increased muscle contractility, and increased electrically evoked calcium release. In the trkB.T1 null muscle, we identified an increase in Akt activation in resting muscle as well as a significant increase in trkB.FL and Akt activation in response to contractile activity. On the basis of these findings, we conclude that the trkB signaling pathway might represent a novel target for intervention across diseases characterized by deficits in neuromuscular function.
Assuntos
Contração Muscular/genética , Junção Neuromuscular/genética , Receptor trkB/deficiência , Receptor trkB/genética , Animais , Cálcio/metabolismo , Masculino , Camundongos , Camundongos Endogâmicos C57BL , Camundongos Knockout , Atividade Motora/genética , Atividade Motora/fisiologia , Contração Muscular/fisiologia , Junção Neuromuscular/fisiologia , Receptor trkB/fisiologiaRESUMO
The internet is frequently the first point of contact for people seeking support for their mental health symptoms. Digital interventions designed to be deployed through the internet have significant promise to reach diverse populations who may not have access to, or are not yet engaged in, treatment and deliver evidence-based resources to address symptoms. The liminal nature of online interactions requires designing to prioritize needs detection, intervention potency, and efficiency. Real-world implementation, data privacy and safety are equally important and can involve transparent partnerships with stakeholders in industry and non-profit organizations. This commentary highlights challenges and opportunities for research in this space, grounded in learnings from multiple research projects and teams aligned with this effort.
RESUMO
BACKGROUND: Smartphones are increasingly used in health research. They provide a continuous connection between participants and researchers to monitor long-term health trajectories of large populations at a fraction of the cost of traditional research studies. However, despite the potential of using smartphones in remote research, there is an urgent need to develop effective strategies to reach, recruit, and retain the target populations in a representative and equitable manner. OBJECTIVE: We aimed to investigate the impact of combining different recruitment and incentive distribution approaches used in remote research on cohort characteristics and long-term retention. The real-world factors significantly impacting active and passive data collection were also evaluated. METHODS: We conducted a secondary data analysis of participant recruitment and retention using data from a large remote observation study aimed at understanding real-world factors linked to cold, influenza, and the impact of traumatic brain injury on daily functioning. We conducted recruitment in 2 phases between March 15, 2020, and January 4, 2022. Over 10,000 smartphone owners in the United States were recruited to provide 12 weeks of daily surveys and smartphone-based passive-sensing data. Using multivariate statistics, we investigated the potential impact of different recruitment and incentive distribution approaches on cohort characteristics. Survival analysis was used to assess the effects of sociodemographic characteristics on participant retention across the 2 recruitment phases. Associations between passive data-sharing patterns and demographic characteristics of the cohort were evaluated using logistic regression. RESULTS: We analyzed over 330,000 days of engagement data collected from 10,000 participants. Our key findings are as follows: first, the overall characteristics of participants recruited using digital advertisements on social media and news media differed significantly from those of participants recruited using crowdsourcing platforms (Prolific and Amazon Mechanical Turk; P<.001). Second, participant retention in the study varied significantly across study phases, recruitment sources, and socioeconomic and demographic factors (P<.001). Third, notable differences in passive data collection were associated with device type (Android vs iOS) and participants' sociodemographic characteristics. Black or African American participants were significantly less likely to share passive sensor data streams than non-Hispanic White participants (odds ratio 0.44-0.49, 95% CI 0.35-0.61; P<.001). Fourth, participants were more likely to adhere to baseline surveys if the surveys were administered immediately after enrollment. Fifth, technical glitches could significantly impact real-world data collection in remote settings, which can severely impact generation of reliable evidence. CONCLUSIONS: Our findings highlight several factors, such as recruitment platforms, incentive distribution frequency, the timing of baseline surveys, device heterogeneity, and technical glitches in data collection infrastructure, that could impact remote long-term data collection. Combined together, these empirical findings could help inform best practices for monitoring anomalies during real-world data collection and for recruiting and retaining target populations in a representative and equitable manner.
RESUMO
Most people with mental health disorders cannot receive timely and evidence-based care despite billions of dollars spent by healthcare systems. Researchers have been exploring using digital health technologies to measure behavior in real-world settings with mixed results. There is a need to create accessible and computable digital mental health datasets to advance inclusive and transparently validated research for creating robust real-world digital biomarkers of mental health. Here we share and describe one of the largest and most diverse real-world behavior datasets from over two thousand individuals across the US. The data were generated as part of the two NIMH-funded randomized clinical trials conducted to assess the effectiveness of delivering mental health care continuously remotely. The longitudinal dataset consists of self-assessment of mood, depression, anxiety, and passively gathered phone-based behavioral data streams in real-world settings. This dataset will provide a timely and long-term data resource to evaluate analytical approaches for developing digital behavioral markers and understand the effectiveness of mental health care delivered continuously and remotely.
Assuntos
Depressão , Smartphone , Ansiedade , Humanos , Saúde Mental , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Ideally, a patient's response to medication can be monitored by measuring changes in performance of some activity. In observational studies, however, any detected association between treatment ("on-medication" vs "off-medication") and the outcome (performance in the activity) might be due to confounders. In particular, causal inferences at the personalized level are especially vulnerable to confounding effects that arise in a cyclic fashion. For quick acting medications, effects can be confounded by circadian rhythms and daily routines. Using the time-of-the-day as a surrogate for these confounders and the performance measurements as captured on a smartphone, we propose a personalized statistical approach to disentangle putative treatment and "time-of-the-day" effects, that leverages conditional independence relations spanned by causal graphical models involving the treatment, time-of-the-day, and outcome variables. Our approach is based on conditional independence tests implemented via standard and temporal linear regression models. Using synthetic data, we investigate when and how residual autocorrelation can affect the standard tests, and how time series modeling (namely, ARIMA and robust regression via HAC covariance matrix estimators) can remedy these issues. In particular, our simulations illustrate that when patients perform their activities in a paired fashion, positive autocorrelation can lead to conservative results for the standard regression approach (i.e., lead to deflated true positive detection), whereas negative autocorrelation can lead to anticonservative behavior (i.e., lead to inflated false positive detection). The adoption of time series methods, on the other hand, leads to well controlled type I error rates. We illustrate the application of our methodology with data from a Parkinson's disease mobile health study.
Assuntos
Medicina de Precisão , Telemedicina , Causalidade , Humanos , Modelos Lineares , SmartphoneRESUMO
[This corrects the article DOI: 10.2196/32165.].
RESUMO
Remote health assessments that gather real-world data (RWD) outside clinic settings require a clear understanding of appropriate methods for data collection, quality assessment, analysis and interpretation. Here we examine the performance and limitations of smartphones in collecting RWD in the remote mPower observational study of Parkinson's disease (PD). Within the first 6 months of study commencement, 960 participants had enrolled and performed at least five self-administered active PD symptom assessments (speeded tapping, gait/balance, phonation or memory). Task performance, especially speeded tapping, was predictive of self-reported PD status (area under the receiver operating characteristic curve (AUC) = 0.8) and correlated with in-clinic evaluation of disease severity (r = 0.71; P < 1.8 × 10-6) when compared with motor Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Although remote assessment requires careful consideration for accurate interpretation of RWD, our results support the use of smartphones and wearables in objective and personalized disease assessments.
Assuntos
Doença de Parkinson , Smartphone , Marcha , Humanos , Movimento , Doença de Parkinson/diagnóstico , Índice de Gravidade de DoençaRESUMO
Artificial intelligence (AI) in healthcare aims to learn patterns in large multimodal datasets within and across individuals. These patterns may either improve understanding of current clinical status or predict a future outcome. AI holds the potential to revolutionize geriatric mental health care and research by supporting diagnosis, treatment, and clinical decision-making. However, much of this momentum is driven by data and computer scientists and engineers and runs the risk of being disconnected from pragmatic issues in clinical practice. This interprofessional perspective bridges the experiences of clinical scientists and data science. We provide a brief overview of AI with the main focus on possible applications and challenges of using AI-based approaches for research and clinical care in geriatric mental health. We suggest future AI applications in geriatric mental health consider pragmatic considerations of clinical practice, methodological differences between data and clinical science, and address issues of ethics, privacy, and trust.