Can Wrist-Worn Medical Devices Correctly Identify Ovulation?

(1) Background: Hormonal fluctuations across the menstrual cycle lead to multiple changes in physiological parameters such as body temperature, cardiovascular function, respiratory rate and perfusion. Electronic wearables analyzing those parameters might present a convenient alternative to urinary ovulation tests for predicting the fertile window. (2) Methods: We conducted a prospective observational study including women aged 18–45 years without current hormonal therapy who used a wrist-worn medical device and urinary ovulation tests for a minimum of three cycles. We analyzed the accuracy of both the retrospective and prospective algorithms using a generalized linear mixed-effects model. The findings were compared to real-world data from bracelet users who also reported urinary ovulation tests. (3) Results: A total of 61 study participants contributing 205 cycles and 6081 real-life cycles from 3268 bracelet users were included in the analysis. The mean error in identifying ovulation with the wrist-worn medical device retrospective algorithm in the clinical study was 0.31 days (95% CI −0.13 to 0.75). The retrospective algorithm identified 75.4% of fertile days, and the prospective algorithm identified 73.8% of fertile days correctly within the pre-specified equivalence limits (±2 days). The quality of the retrospective algorithm in the clinical study could be confirmed by real-world data. (4) Conclusion: Our data indicate that wearable sensors may be used to accurately detect the periovulatory period

Changes in Heart Rate, Heart Rate Variability, Breathing Rate, and Skin Temperature throughout Pregnancy and the Impact of Emotions—A Longitudinal Evaluation Using a Sensor Bracelet

(1) Background: Basic vital signs change during normal pregnancy as they reflect the adaptation of maternal physiology. Electronic wearables like fitness bracelets have the potential to provide vital signs continuously in the home environment of pregnant women. (2) Methods: We performed a prospective observational study from November 2019 to November 2020 including healthy pregnant women, who recorded their wrist skin temperature, heart rate, heart rate variability, and breathing rate using an electronic wearable. In addition, eight emotions were assessed weekly using five-point Likert scales. Descriptive statistics and a multivariate model were applied to correlate the physiological parameters with maternal emotions. (3) Results: We analyzed data from 23 women using the electronic wearable during pregnancy. We calculated standard curves for each physiological parameter, which partially differed from the literature. We showed a significant association of several emotions like feeling stressed, tired, or happy with the course of physiological parameters. (4) Conclusions: Our data indicate that electronic wearables are helpful for closely observing vital signs in pregnancy and to establish modern curves for the physiological course of these parameters. In addition to physiological adaptation mechanisms and pregnancy disorders, emotions have the potential to influence the course of physiological parameters in pregnancy

Active surveillance for rheumatic heart disease in endemic regions: a systematic review and meta-analysis of prevalence among children and adolescents

Background Rheumatic heart disease accounts for up to 250 000 premature deaths every year worldwide and can be regarded as a physical manifestation of poverty and social inequality. We aimed to estimate the prevalence of rheumatic heart disease in endemic countries as assessed by diff erent screening modalities and as a function of age. Methods We searched Medline, Embase, the Latin American and Caribbean System on Health Sciences Information, African Journals Online, and the Cochrane Database of Systematic Reviews for population-based studies published between Jan 1, 1993, and June 30, 2014, that reported on prevalence of rheumatic heart disease among children and adolescents (≥5 years to <18 years). We assessed prevalence of clinically silent and clinically manifest rheumatic heart disease in random eff ects meta-analyses according to screening modality and geographical region. We assessed the association between social inequality and rheumatic heart disease with the Gini coeffi cient. We used Poisson regression to analyse the eff ect of age on prevalence of rheumatic heart disease and estimated the incidence of rheumatic heart disease from prevalence data. Findings We included 37 populations in the systematic review and meta-analysis. The pooled prevalence of rheumatic heart disease detected by cardiac auscultation was 2·9 per 1000 people (95% CI 1·7–5·0) and by echocardiography it was 12·9 per 1000 people (8·9–18·6), with substantial heterogeneity between individual reports for both screening modalities (I²=99·0% and 94·9%, respectively). We noted an association between social inequality expressed by the Gini coeffi cient and prevalence of rheumatic heart disease (p=0·0002). The prevalence of clinically silent rheumatic heart disease (21·1 per 1000 people, 95% CI 14·1–31·4) was about seven to eight times higher than that of clinically manifest disease (2·7 per 1000 people, 1·6–4·4). Prevalence progressively increased with advancing age, from 4·7 per 1000 people (95% CI 0·0–11·2) at age 5 years to 21·0 per 1000 people (6·8–35·1) at 16 years. The estimated incidence was 1·6 per 1000 people (0·8–2·3) and remained constant across age categories (range 2·5, 95% CI 1·3–3·7 in 5-year-old children to 1·7, 0·0–5·1 in 15-year-old adolescents). We noted no sexrelated diff erences in prevalence (p=0·829). Interpretation We found a high prevalence of rheumatic heart disease in endemic countries. Although a reduction in social inequalities represents the cornerstone of community-based prevention, the importance of early detection of silent rheumatic heart disease remains to be further assessed

Effectiveness of Systematic Echocardiographic Screening for Rheumatic Heart Disease in Nepalese Schoolchildren: A Cluster Randomized Clinical Trial.

Importance Echocardiographic screening allows for early detection of subclinical stages of rheumatic heart disease among children in endemic regions. Objective To investigate the effectiveness of systematic echocardiographic screening in combination with secondary antibiotic prophylaxis on the prevalence of rheumatic heart disease. Design, Setting, and Participants This cluster randomized clinical trial included students 9 to 16 years of age attending public and private schools in urban and rural areas of the Sunsari district in Nepal that had been randomly selected on November 17, 2012. Echocardiographic follow-up was performed between January 7, 2016, and January 3, 2019. Interventions In the experimental group, children underwent systematic echocardiographic screening followed by secondary antibiotic prophylaxis in case they had echocardiographic evidence of latent rheumatic heart disease. In the control group, children underwent no echocardiographic screening. Main Outcomes and Measures Prevalence of the composite of definite or borderline rheumatic heart disease according to the World Heart Federation criteria in experimental and control schools as assessed 4 years after intervention. Results A total of 35 schools were randomized to the experimental group (n = 19) or the control group (n = 16). After a median of 4.3 years (interquartile range [IQR], 4.0-4.5 years), 17 of 19 schools in the experimental group (2648 children; median age at follow-up, 12.1 years; IQR, 10.3-12.5 years; 1308 [49.4%] male) and 15 of 16 schools in the control group (1325 children; median age at follow-up, 10.6 years; IQR, 10.0-12.5 years; 682 [51.5%] male) underwent echocardiographic follow-up. The prevalence of definite or borderline rheumatic heart disease was 10.8 per 1000 children (95% CI, 4.7-24.7) in the control group and 3.8 per 1000 children (95% CI, 1.5-9.8) in the experimental group (odds ratio, 0.34; 95% CI, 0.11-1.07; P = .06). The prevalence in the experimental group at baseline had been 12.9 per 1000 children (95% CI, 9.2-18.1). In the experimental group, the odds ratio of definite or borderline rheumatic heart disease at follow-up vs baseline was 0.29 (95% CI, 0.13-0.65; P = .008). Conclusions and Relevance School-based echocardiographic screening in combination with secondary antibiotic prophylaxis in children with evidence of latent rheumatic heart disease may be an effective strategy to reduce the prevalence of definite or borderline rheumatic heart disease in endemic regions. Trial Registration ClinicalTrials.gov Identifier: NCT01550068

Determinants of radiation dose during right transradial access. insights from the RAD-MATRIX study

Background The RAD-MATRIX trial reported a large operator radiation exposure variability in right radial percutaneous coronary procedures. The reasons of these differences are not well understood. Our aim was to appraise the determinants of operator radiation exposure during coronary right transradial procedures. Methods Patient arrangement during transradial intervention was investigated across operators involved in the RAD-MATRIX trial. Operator radiation exposure was analyzed according to the position of the patient right arm (close or far from the body) and in relation to the size of the upper leaded glass. Results Among the 14 operators who agreed to participate, there was a greater than 10-fold difference in radiation dose at thorax level (from 21.5 to 267 μSv) that persisted after normalization by dose-area product (from 0.35 to 3.5 μSv/Gy*cm2). Among the operators who positioned the instrumented right arm far from the body (110.4 μSv, interquartile range 71.5-146.5 μSv), thorax dose was greater than that in those who placed the instrumented arm close to the right leg (46.1 μSv, 31.3-56.8 μSv, P =.02). This difference persisted after normalization by dose-area product (P =.028). The use of a smaller full glass shield was also associated with a higher radiation exposure compared with a larger composite shield (147.5 and 60 μSv, respectively, P =.016). Conclusions In the context of the biggest radiation study conducted in patients undergoing transradial catheterization, the instrumented right arm arrangement close to the leg and greater upper leaded shield dimensions were associated with a lower operator radiation exposure. Our findings emphasize the importance of implementing simple preventive measures to mitigate the extra risks of radiation exposure with right radial as compared with femoral access

Investigation of the use of a sensor bracelet for the presymptomatic detection of changes in physiological parameters related to COVID-19: an interim analysis of a prospective cohort study (COVI-GAPP).

OBJECTIVES We investigated machinelearningbased identification of presymptomatic COVID-19 and detection of infection-related changes in physiology using a wearable device. DESIGN Interim analysis of a prospective cohort study. SETTING, PARTICIPANTS AND INTERVENTIONS Participants from a national cohort study in Liechtenstein were included. Nightly they wore the Ava-bracelet that measured respiratory rate (RR), heart rate (HR), HR variability (HRV), wrist-skin temperature (WST) and skin perfusion. SARS-CoV-2 infection was diagnosed by molecular and/or serological assays. RESULTS A total of 1.5 million hours of physiological data were recorded from 1163 participants (mean age 44±5.5 years). COVID-19 was confirmed in 127 participants of which, 66 (52%) had worn their device from baseline to symptom onset (SO) and were included in this analysis. Multi-level modelling revealed significant changes in five (RR, HR, HRV, HRV ratio and WST) device-measured physiological parameters during the incubation, presymptomatic, symptomatic and recovery periods of COVID-19 compared with baseline. The training set represented an 8-day long instance extracted from day 10 to day 2 before SO. The training set consisted of 40 days measurements from 66 participants. Based on a random split, the test set included 30% of participants and 70% were selected for the training set. The developed long short-term memory (LSTM) based recurrent neural network (RNN) algorithm had a recall (sensitivity) of 0.73 in the training set and 0.68 in the testing set when detecting COVID-19 up to 2 days prior to SO. CONCLUSION Wearable sensor technology can enable COVID-19 detection during the presymptomatic period. Our proposed RNN algorithm identified 68% of COVID-19 positive participants 2 days prior to SO and will be further trained and validated in a randomised, single-blinded, two-period, two-sequence crossover trial. Trial registration number ISRCTN51255782; Pre-results

Bivalirudin or unfractionated heparin in patients with acute coronary syndromes managed invasively with and without ST elevation (MATRIX): randomised controlled trial.

OBJECTIVE  To test the optimal antithrombotic regimen in patients with acute coronary syndrome. DESIGN  Randomised controlled trial. SETTING  Patients with acute coronary syndrome with and without ST segment elevation in 78 centres in Italy, the Netherlands, Spain, and Sweden. PARTICIPANTS  7213 patients with acute coronary syndrome and planned percutaneous coronary intervention: 4010 with ST segment elevation and 3203 without ST segment elevation. The primary study results in the overall population have been reported previously. INTERVENTIONS  Patients were randomly assigned, in an open label fashion, to one of two regimens: bivalirudin with glycoprotein IIb/IIIa inhibitors restricted to procedural complications or heparin with or without glycoprotein IIb/IIIa inhibitors. MAIN OUTCOME MEASURES  Primary endpoints were the occurrence of major adverse cardiovascular events, defined as death, myocardial infarction or stroke; and net adverse clinical events, defined as major bleeding or major adverse cardiovascular events, both assessed at 30 days. Analyses were performed by the principle of intention to treat. RESULTS  Use of a glycoprotein IIb/IIIa inhibitor in patients assigned to heparin was planned at baseline in 30.7% of patients with ST segment elevation, in 10.9% without ST segment elevation, and in no patients assigned to bivalirudin. In patients with ST segment elevation, major adverse cardiovascular events occurred in 118 (5.9%) assigned to bivalirudin and 129 (6.5%) assigned to heparin (rate ratio 0.90, 95% confidence interval 0.70 to 1.16; P=0.43), whereas net adverse clinical events occurred in 139 (7.0%) patients assigned to bivalirudin and 163 (8.2%) assigned to heparin (0.84, 0.67 to 1.05; P=0.13). In patients without ST segment elevation, major adverse cardiovascular events occurred in 253 (15.9%) assigned to bivalirudin and 262 (16.4%) assigned to heparin (0.97, 0.80 to 1.17; P=0.74), whereas net adverse clinical events occurred in 262 (16.5%) patients assigned to bivalirudin and 281 (17.6%) assigned to heparin (0.93, 0.77 to 1.12; P=0.43). CONCLUSIONS  A bivalirudin monotherapy strategy compared with heparin with or without glycoprotein IIb/IIIa inhibitors, did not result in reduced major adverse cardiovascular events or net adverse clinical events in patients with or without ST segment elevation.Trial Registration ClinicalTrials.gov NCT01433627

Sex-specific differences in physiological parameters related to SARS-CoV-2 infections among a national cohort (COVI-GAPP study)

Considering sex as a biological variable in modern digital health solutions, we investigated sex-specific differences in the trajectory of four physiological parameters across a COVID-19 infection. A wearable medical device measured breathing rate, heart rate, heart rate variability, and wrist skin temperature in 1163 participants (mean age = 44.1 years, standard deviation [SD] = 5.6; 667 [57%] females). Participants reported daily symptoms and con-founders in a complementary app. A machine learning algorithm retrospectively ingested daily biophysical parameters to detect COVID-19 infections. COVID-19 serology samples were collected from all participants at baseline and follow-up. We analysed potential sex-specific differences in physiology and antibody titres using multilevel modelling and t-tests. Over 1.5 million hours of physiological data were recorded. During the symptomatic period of infection, men demonstrated larger increases in skin temperature, breathing rate, and heart rate as well as larger decreases in heart rate variability than women. The COVID-19 infection detection algorithm performed similarly well for men and women. Our study belongs to the first research to provide evidence for differential physiological responses to COVID-19 between females and males, highlighting the potential of wearable technology to inform future precision medicine approaches

Surveying Human Vulnerabilities across the Life Course

Este libro fue publicado en 2016 y esta es una edición corregida de 2018. El libro completo está sujeto a una licencia CC BY 4.0This open access book details tools and procedures for data collections of hard-to-reach, hard-to-survey populations. Inside, readers will discover first-hand insights from experts who share their successes as well as their failures in their attempts to identify and measure human vulnerabilities across the life course. Coverage first provides an introduction on studying vulnerabilities based on the Total Error Survey framework. Next, the authors present concrete examples on how to survey such populations as the elderly, migrants, widows and widowers, couples facing breast cancer, employees and job seekers, displaced workers, and teenagers during their transition to adulthood. In addition, one essay discusses the rationale for the use of life history calendars in studying social and psychological vulnerability while another records the difficulty the authors faced when trying to set-up an online social network to collect relevant data. Overall, this book demonstrates the importance to have, from the very beginning, a dialogue between specialists of survey methods and the researchers working on social dynamics across the life span. It will serve as an indispensable resource for social scientists interested in gathering and analyzing data on vulnerable individuals and populations in order to construct longitudinal data bases and properly target social policies.Peer reviewe