scholarly journals A framework for smartphone-enabled, patient-generated health data analysis

PeerJ ◽  
2016 ◽  
Vol 4 ◽  
pp. e2284 ◽  
Author(s):  
Shreya S. Gollamudi ◽  
Eric J. Topol ◽  
Nathan E. Wineinger
Keyword(s):  
Blood Pressure ◽  
Hypothesis Testing ◽  
Repeated Measures ◽  
Sequential Analysis ◽  
Monitoring Program ◽  
Health Data ◽  
Series Data ◽  
Testing Framework ◽  
Health Technologies ◽  
Digital Medicine

Background:Digital medicine and smartphone-enabled health technologies provide a novel source of human health and human biology data. However, in part due to its intricacies, few methods have been established to analyze and interpret data in this domain. We previously conducted a six-month interventional trial examining the efficacy of a comprehensive smartphone-based health monitoring program for individuals with chronic disease. This included 38 individuals with hypertension who recorded 6,290 blood pressure readings over the trial.Methods:In the present study, we provide a hypothesis testing framework for unstructured time series data, typical of patient-generated mobile device data. We used a mixed model approach for unequally spaced repeated measures using autoregressive and generalized autoregressive models, and applied this to the blood pressure data generated in this trial.Results:We were able to detect, roughly, a 2 mmHg decrease in both systolic and diastolic blood pressure over the course of the trial despite considerable intra- and inter-individual variation. Furthermore, by supplementing this finding by using a sequential analysis approach, we observed this result over three months prior to the official study end—highlighting the effectiveness of leveraging the digital nature of this data source to form timely conclusions.Conclusions:Health data generated through the use of smartphones and other mobile devices allow individuals the opportunity to make informed health decisions, and provide researchers the opportunity to address innovative health and biology questions. The hypothesis testing framework we present can be applied in future studies utilizing digital medicine technology or implemented in the technology itself to support the quantified self.

scholarly journals A framework for smartphone-enabled, patient-generated health data analysis

2016 ◽  
Author(s):  
Shreya S Gollamudi ◽  
Eric J Topol ◽  
Nathan E Wineinger
Keyword(s):  
Blood Pressure ◽  
Hypothesis Testing ◽  
Repeated Measures ◽  
Sequential Analysis ◽  
Monitoring Program ◽  
Health Data ◽  
Series Data ◽  
Testing Framework ◽  
Health Technologies ◽  
Digital Medicine

Background: Digital medicine and smartphone-enabled health technologies provide a novel source of human health and human biology data. However, in part due to its intricacies, few methods have been established to analyze and interpret data in this domain. We previously conducted a six-month interventional trial examining the efficacy of a comprehensive smartphone-based health monitoring program for individuals with chronic disease. This included 38 individuals with hypertension who recorded 6,290 blood pressure readings over the trial. Methods: In the present study we provide a hypothesis testing framework for unstructured time series data, typical of patient-generated mobile device data. We used a mixed model approach for unequally spaced repeated measures using autoregressive and generalized autoregressive models, and applied this to the blood pressure data generated in this trial. Results: We were able to detect, roughly, a 2 mmHg decrease in both systolic and diastolic blood pressure over the course of the trial despite considerable intra- and inter-individual variation. Furthermore, by supplementing this finding by using a sequential analysis approach, we observed this result over three months prior to the official study end – highlighting the effectiveness of leveraging the digital nature of this data source to form timely conclusions. Conclusions: Health data generated through the use of smartphones and other mobile devices allow individuals the opportunity to make informed health decisions, and provide researchers the opportunity to address innovative health and biology questions. The hypothesis testing framework we present can be applied in future studies utilizing digital medicine technology or implemented in the technology itself to support the quantified self. The study was registered at clinicaltrials.gov (NCT01975428).

scholarly journals A framework for smartphone-enabled, patient-generated health data analysis

2016 ◽  
Author(s):  
Shreya S Gollamudi ◽  
Eric J Topol ◽  
Nathan E Wineinger
Keyword(s):  
Blood Pressure ◽  
Hypothesis Testing ◽  
Repeated Measures ◽  
Sequential Analysis ◽  
Monitoring Program ◽  
Health Data ◽  
Series Data ◽  
Testing Framework ◽  
Health Technologies ◽  
Digital Medicine

Background: Digital medicine and smartphone-enabled health technologies provide a novel source of human health and human biology data. However, in part due to its intricacies, few methods have been established to analyze and interpret data in this domain. We previously conducted a six-month interventional trial examining the efficacy of a comprehensive smartphone-based health monitoring program for individuals with chronic disease. This included 38 individuals with hypertension who recorded 6,290 blood pressure readings over the trial. Methods: In the present study we provide a hypothesis testing framework for unstructured time series data, typical of patient-generated mobile device data. We used a mixed model approach for unequally spaced repeated measures using autoregressive and generalized autoregressive models, and applied this to the blood pressure data generated in this trial. Results: We were able to detect, roughly, a 2 mmHg decrease in both systolic and diastolic blood pressure over the course of the trial despite considerable intra- and inter-individual variation. Furthermore, by supplementing this finding by using a sequential analysis approach, we observed this result over three months prior to the official study end – highlighting the effectiveness of leveraging the digital nature of this data source to form timely conclusions. Conclusions: Health data generated through the use of smartphones and other mobile devices allow individuals the opportunity to make informed health decisions, and provide researchers the opportunity to address innovative health and biology questions. The hypothesis testing framework we present can be applied in future studies utilizing digital medicine technology or implemented in the technology itself to support the quantified self. The study was registered at clinicaltrials.gov (NCT01975428).

Association between ibrutinib treatment and hypertension

Heart ◽  
2021 ◽  
pp. heartjnl-2021-319110
Author(s):  
Dae Hyun Lee ◽  
Fahad Hawk ◽  
Kieun Seok ◽  
Matthew Gliksman ◽  
Josephine Emole ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Repeated Measures ◽  
Treatment Initiation ◽  
Kinase Inhibitor ◽  
Pressure Change ◽  
Exact Test ◽  
N 93 ◽  
Pressure Changes ◽  
Over Time

BackgroundIbrutinib is a tyrosine kinase inhibitor most commonly associated with atrial fibrillation. However, additional cardiotoxicities have been identified, including accelerated hypertension. The incidence and risk factors of new or worsening hypertension following ibrutinib treatment are not as well known.MethodsWe conducted a retrospective study of 144 patients diagnosed with B cell malignancies treated with ibrutinib (n=93) versus conventional chemoimmunotherapy (n=51) and evaluated their effects on blood pressure at 1, 2, 3 and 6 months after treatment initiation. Descriptive statistics were used to compare baseline characteristics for each treatment group. Fisher’s exact test was used to identify covariates significantly associated with the development of hypertension. Repeated measures analyses were conducted to analyse longitudinal blood pressure changes.ResultsBoth treatments had similar prevalence of baseline hypertension at 63.4% and 66.7%, respectively. There were no differences between treatments by age, sex and baseline cardiac comorbidities. Both systolic and diastolic blood pressure significantly increased over time with ibrutinib compared with baseline, whereas conventional chemoimmunotherapy was not associated with significant changes in blood pressure. Baseline hypertensive status did not affect the degree of blood pressure change over time. A significant increase in systolic blood pressure (defined as more than 10 mm Hg) was noted for ibrutinib (36.6%) compared with conventional chemoimmunotherapy (7.9%) at 1 month after treatment initiation. Despite being hypertensive at follow-up, 61.2% of patients who were treated with ibrutinib did not receive adequate blood pressure management (increase or addition of blood pressure medications). Within the ibrutinib group, of patients who developed more than 20 mm Hg increase in systolic blood pressure, only 52.9% had hypertension management changes.ConclusionsIbrutinib is associated with the development of hypertension and worsening of blood pressure. Cardiologists and oncologists must be aware of this cardiotoxicity to allow timely management of blood pressure elevations.

Abstract MP03: ROCK2 Specific Inhibition Attenuates Angiotensin II-induced Hypertension In Mice

Hypertension ◽  
2021 ◽  
Vol 78 (Suppl_1) ◽  
Author(s):  
Daniel J Fehrenbach ◽  
Meena S Madhur
Keyword(s):  
Blood Pressure ◽  
T Cell ◽  
Angiotensin Ii ◽  
Repeated Measures ◽  
Flow Cytometric Analysis ◽  
Coiled Coil ◽  
Ang Ii ◽  
Induced Hypertension

Hypertension, or an elevated blood pressure, is the primary modifiable risk factor for cardiovascular disease, the number one cause of mortality worldwide. We previously demonstrated that Th17 activation and interleukin 17A (IL-17A)/IL-21 production is integral for the full development of a hypertensive phenotype as well as the renal and vascular damage associated with hypertension. Rho-associated coiled-coil containing protein Kinase 2 (ROCK2) serves as a molecular switch upregulating Th17 and inhibiting regulatory T cell (Treg) differentiation. We hypothesize that hypertension is characterized by excessive T cell ROCK2 activation leading to increased Th17/Treg ratios and ultimately end-organ damage. We first showed in vitro that KD025, an experimental orally bioavailable ROCK2 inhibitor inhibits Th17 cell proliferation and IL-17A/IL-21 production. To determine if hypertensive stimuli such as endothelial stretch increases T cell ROCK2 expression, we cultured human aortic endothelial cells exposed to 5% (normotensive) or 10% (hypertensive) stretch with circulating human T cells and HLA-DR+ antigen presenting cells. Hypertensive stretch increased T cell ROCK2 expression 2-fold. We then tested the effect of ROCK2 inhibition with KD025 (50mg/kg i.p. daily) in vivo on angiotensin II (Ang II)-induced hypertension. Treatment with KD025 significantly attenuated the hypertensive response within 1 week of Ang II treatment (systolic blood pressure: 139± 8 vs 108±7mmHg) and this persisted for the duration of the 4 week study reaching blood pressures 20 mmHg lower (135±13mmHg) than vehicle treated mice (158±4mmHg p<0.05 effect of treatment 2-way Repeated Measures ANOVA). Flow cytometric analysis of tissue infiltrating leukocytes revealed that KD025 treatment increased Treg/Th17 ratios in the kidney (0.61±0.03 vs 0.79±0.08, p<0.05 student’s t-test). Thus, T cell ROCK2 may be a novel therapeutic target for the treatment of hypertension.

scholarly journals Negative Air Pressure on Wet Cupping in Decreasing Blood Pressures in Hypertensive Patients

2018 ◽  
Vol 7 (2) ◽  
pp. 116
Author(s):  
Budi Darmawan ◽  
Diyah Fatmasari ◽  
Rr. Sri Endang Pujiast
Keyword(s):  
Blood Pressure ◽  
Repeated Measures ◽  
Community Health Centers ◽  
Intervention Group ◽  
Air Pressure ◽  
Control Group ◽  
P Value ◽  
Decrease Blood Pressure ◽  
Blood Pressures ◽  
The Mean

Background: Wet cupping, furthermore mentioned cupping, decreases blood pressures through the level of negative air pressures added by hydrostatics filtration pressure to reinforce the power of fluids filtration in capillaries. However, an appropriate negative air pressure to decrease blood pressure remains an uncertainty.Purpose: This study aimed to analyze negative air pressure differences on cupping in decreasing blood pressures in hypertensive patients.Methods: This is a quasi-experimental design conducted in three Community Health Centers in Langsa City, Aceh, Indonesia. The samples were 36 hypertensive males with age from 45 to 55, who were randomly stratified into two groups with cupping pressures 400 mbar (n=18) as the control group; and 540 mbar (n=18) as the intervention group. The cupping session was performed to each group on T1 (alkahil) point and in the middle line of both shoulders blade points. The systolic blood pressure (SBP) and diastolic blood pressures (DBP) were measured by validated automatic sphygmomanometer. The follow-up periods were one week and two weeks. The data were then analyzed by repeated measures ANOVA.Results: Cupping pressure of 400 mbar decreased the mean of SBP and DPB with a p-value of 0.450 and 0.026, respectively after two weeks of intervention. Meanwhile, cupping pressure of 540 mbar decreased the mean of SBP and DBP with a p-value of 0.006 and 0.057, respectively. Tests of within-subjects resulted in the p-value of 0.250 (SBP) and 0.176 (DBP) after two weeks of intervention. There were no significant differences in SBP and DBP between the intervention group and the control group.Conclusion: The cupping pressure between 400 mbar and 540 mbar could reduce blood pressure; however, the cupping pressure of 540 mbar yielded greater effect in decreasing blood pressure than the 400 mbar. Negative air vacuum pressure loads on cupping to decrease blood pressure should be considered between 400 to 540 mbar, and further studies are needed.

scholarly journals The Effect of the Mobile ‘Blood Pressure Management Application’ on Hypertension Self-Management Enhancement: A Randomised Controlled Trial

2019 ◽  
Author(s):  
Ali Bozorgi ◽  
Hamed Hosseini ◽  
Hassan Eftekhar ◽  
Reza Majdzadeh ◽  
Ali Yoonessi ◽  
...  
Keyword(s):  
Physical Activity ◽  
Blood Pressure ◽  
Clinical Trial ◽  
Repeated Measures ◽  
Patient Adherence ◽  
Intervention Group ◽  
Public Hospitals ◽  
Self Management ◽  
Control Group ◽  
Management Application

Abstract Background : Self-management of blood pressure is of great significance given the increasing incidence of hypertension and associated disabilities. With the increased use of mobile health in medicine, the present study evaluated the effect of the self-management application on patient adherence to hypertension treatment. Methods : This clinical trial was performed on 120 hypertensive patients who were provided with a mobile intervention for 8 weeks and followed-up to 24 th weeks. Data on the primary outcome (adherence to treatment) and secondary outcomes (adherence to the DASH diet, regular monitoring of blood pressure, and physical activity) were collected using a questionnaire and a mobile application, respectively. The inter-group change difference over time was analyzed using repeated measures ANOVA (General Linear Model). Results : The treatment adherence score increased by an average of 5.9 (95%CI: 5.0-6.7) in the intervention group compared to the control group. Scores of adherence to the low-fat and low-salt diet plans were 1.7 (95%CI: 1.3-2.1) and 1.5 (95%CI: 1.2-1.9), respectively. Moreover, moderate physical activity increased to 100.0 minutes (95%CI: 61.7-138.3) per week in the intervention group. Conclusion: The treatment and control of blood pressure require a multifaceted approach given its complexity and multifactorial nature. Considering the widespread use of smartphones , mhealth interventions can be effective in self-management and better patient adherence to treatments. Our results showed that this application can be used as a successful tool for hypertension self-management in patients attending public hospitals in developing countries. Trial registration: This study was registered in the Iran Randomized Clinical Trial Center under the number IRCT2015111712211N2 on 1 January 2016.

scholarly journals Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations

2021 ◽  
pp. 191-205
Author(s):  
Michelle Crouthamel ◽  
Robert J. Mather ◽  
Suraj Ramachandran ◽  
Kai Bode ◽  
Godhuli Chatterjee ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Drug Development ◽  
Sleep Disturbances ◽  
Digital Health ◽  
The Novel ◽  
Tool Selection ◽  
Health Technologies ◽  
Study Approach ◽  
Digital Medicine ◽  
Regulatory Strategy

The development of novel digital endpoints (NDEs) using digital health technologies (DHTs) may provide opportunities to transform drug development. It requires a multidisciplinary, multi-study approach with strategic planning and a regulatory-guided pathway to achieve regulatory and clinical acceptance. Many NDEs have been explored; however, success has been limited. To advance industry use of NDEs to support drug development, we outline a theoretical, methodological study as a use-case proposal to describe the process and considerations when developing and obtaining regulatory acceptance for an NDE to assess sleep in patients with rheumatoid arthritis (RA). RA patients often suffer joint pain, fatigue, and sleep disturbances (SDs). Although many researchers have investigated the mobility of joint functions using wearable technologies, the research of SD in RA has been limited due to the availability of suitable technologies. We proposed measuring the improvement of sleep as the novel endpoint for an anti-TNF therapy and described the meaningfulness of the measure, considerations of tool selection, and the design of clinical validation. The recommendations from the FDA patient-focused drug development guidance, the Clinical Trials Transformation Initiative (CTTI) pathway for developing novel endpoints from DHTs, and the V3 framework developed by the Digital Medicine Society (DiMe) have been incorporated in the proposal. Regulatory strategy and engagement pathways are also discussed.

scholarly journals Minimum time required to detect population trends: the need for long-term monitoring programs

2017 ◽  
Author(s):  
Easton R White
Keyword(s):  
Time Series ◽  
Statistical Power ◽  
Time Series Data ◽  
Conservation Status ◽  
Monitoring Program ◽  
Minimum Time ◽  
Series Data ◽  
Series Length ◽  
Time Required

Long-term time series are necessary to better understand population dynamics, assess species' conservation status, and make management decisions. However, population data are often expensive, requiring a lot of time and resources. When is a population time series long enough to address a question of interest? We determine the minimum time series length required to detect significant increases or decreases in population abundance. To address this question, we use simulation methods and examine 878 populations of vertebrate species. Here we show that 15-20 years of continuous monitoring are required in order to achieve a high level of statistical power. For both simulations and the time series data, the minimum time required depends on trend strength, population variability, and temporal autocorrelation. These results point to the importance of sampling populations over long periods of time. We argue that statistical power needs to be considered in monitoring program design and evaluation. Time series less than 15-20 years are likely underpowered and potentially misleading.

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