Commercially available wearable devices (wearables) show promise for continuous physiological monitoring. Previous works have demonstrated that wearables can be used to detect the onset of acute ...infectious diseases, particularly those characterized by fever. We aimed to evaluate whether these devices could be used for the more general task of syndromic surveillance. We obtained wearable device data (Oura Ring) from 63,153 participants. We constructed a dataset using participants' wearable device data and participants' responses to daily online questionnaires. We included days from the participants if they (1) completed the questionnaire, (2) reported not experiencing fever and reported a self-collected body temperature below 38 °C (negative class), or reported experiencing fever and reported a self-collected body temperature at or above 38 °C (positive class), and (3) wore the wearable device the nights before and after that day. We used wearable device data (i.e., skin temperature, heart rate, and sleep) from the nights before and after participants' fever day to train a tree-based classifier to detect self-reported fevers. We evaluated the performance of our model using a five-fold cross-validation scheme. Sixteen thousand, seven hundred, and ninety-four participants provided at least one valid ground truth day; there were a total of 724 fever days (positive class examples) from 463 participants and 342,430 non-fever days (negative class examples) from 16,687 participants. Our model exhibited an area under the receiver operating characteristic curve (AUROC) of 0.85 and an average precision (AP) of 0.25. At a sensitivity of 0.50, our calibrated model had a false positive rate of 0.8%. Our results suggest that it might be possible to leverage data from these devices at a public health level for live fever surveillance. Implementing these models could increase our ability to detect disease prevalence and spread in real-time during infectious disease outbreaks.
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Correlations between altered body temperature and depression have been reported in small samples; greater confidence in these associations would provide a rationale for further examining potential ...mechanisms of depression related to body temperature regulation. We sought to test the hypotheses that greater depression symptom severity is associated with (1) higher body temperature, (2) smaller differences between body temperature when awake versus asleep, and (3) lower diurnal body temperature amplitude. Data collected included both self-reported body temperature (using standard thermometers), wearable sensor-assessed distal body temperature (using an off-the-shelf wearable sensor that collected minute-level physiological data), and self-reported depressive symptoms from > 20,000 participants over the course of ~ 7 months as part of the TemPredict Study. Higher self-reported and wearable sensor-assessed body temperatures when awake were associated with greater depression symptom severity. Lower diurnal body temperature amplitude, computed using wearable sensor-assessed distal body temperature data, tended to be associated with greater depression symptom severity, though this association did not achieve statistical significance. These findings, drawn from a large sample, replicate and expand upon prior data pointing to body temperature alterations as potentially relevant factors in depression etiology and may hold implications for development of novel approaches to the treatment of major depressive disorder.
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To examine the feasibility of an integrated mind-body MDD treatment combining cognitive behavioral therapy (CBT) and whole-body hyperthermia (WBH).
In this single-arm trial, 16 adults with MDD ...initially received 8 weekly CBT sessions and 8 weekly WBH sessions. Outcomes included WBH sessions completed (primary), self-report depression assessments completed (secondary), and pre-post intervention changes in depression symptoms (secondary). We also explored changes in mood and cognitive processes and assessed changes in mood as predictors of overall treatment response.
Thirteen participants (81.3%) completed
4 WBH sessions (primary outcome); midway through the trial, we reduced from 8 weekly to 4 bi-weekly WBH sessions to increase feasibility. The
= 12 participants who attended the final assessment visit completed 100% of administered self-report depression assessments; all enrolled participants (
= 16) completed 89% of these assessments. Among the
= 12 who attended the final assessment visit, the average pre-post-intervention BDI-II reduction was 15.8 points (95% CI: -22.0, -9.70),
0.0001, with 11 no longer meeting MDD criteria (secondary outcomes). Pre-post intervention improvements in negative automatic thinking, but not cognitive flexibility, achieved statistical significance. Improved mood from pre-post the initial WBH session predicted pre-post treatment BDI-II change (36.2%;
= 0.60,
= 0.038); mood changes pre-post the first CBT session did not.
Small sample size and single-arm design limit generalizability.
An integrated mind-body intervention comprising weekly CBT sessions and bi-weekly WBH sessions was feasible. Results warrant future larger controlled clinical trials.
NCT05708976.
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There is significant variability in neutralizing antibody responses (which correlate with immune protection) after COVID-19 vaccination, but only limited information is available about predictors of ...these responses. We investigated whether device-generated summaries of physiological metrics collected by a wearable device correlated with post-vaccination levels of antibodies to the SARS-CoV-2 receptor-binding domain (RBD), the target of neutralizing antibodies generated by existing COVID-19 vaccines. One thousand, one hundred and seventy-nine participants wore an off-the-shelf wearable device (Oura Ring), reported dates of COVID-19 vaccinations, and completed testing for antibodies to the SARS-CoV-2 RBD during the U.S. COVID-19 vaccination rollout. We found that on the night immediately following the second mRNA injection (Moderna-NIAID and Pfizer-BioNTech) increases in dermal temperature deviation and resting heart rate, and decreases in heart rate variability (a measure of sympathetic nervous system activation) and deep sleep were each statistically significantly correlated with greater RBD antibody responses. These associations were stronger in models using metrics adjusted for the pre-vaccination baseline period. Greater temperature deviation emerged as the strongest independent predictor of greater RBD antibody responses in multivariable models. In contrast to data on certain other vaccines, we did not find clear associations between increased sleep surrounding vaccination and antibody responses.
Background
Daily symptom reporting collected via web-based symptom survey tools holds the potential to improve disease monitoring. Such screening tools might be able to not only discriminate between ...states of acute illness and non-illness, but also make use of additional demographic information so as to identify how illnesses may differ across groups, such as biological sex. These capabilities may play an important role in the context of future disease outbreaks.
Objective
Use data collected via a daily web-based symptom survey tool to develop a Bayesian model that could differentiate between COVID-19 and other illnesses and refine this model to identify illness profiles that differ by biological sex.
Methods
We used daily symptom profiles to plot symptom progressions for COVID-19, influenza (flu), and the common cold. We then built a Bayesian network to discriminate between these three illnesses based on daily symptom reports. We further separated out the COVID-19 cohort into self-reported female and male subgroups to observe any differences in symptoms relating to sex. We identified key symptoms that contributed to a COVID-19 prediction in both males and females using a logistic regression model.
Results
Although the Bayesian model performed only moderately well in identifying a COVID-19 diagnosis (71.6% true positive rate), the model showed promise in being able to differentiate between COVID-19, flu, and the common cold, as well as periods of acute illness vs. non-illness. Additionally, COVID-19 symptoms differed between the biological sexes; specifically, fever was a more important symptom in identifying subsequent COVID-19 infection among males than among females.
Conclusion
Web-based symptom survey tools hold promise as tools to identify illness and may help with coordinated disease outbreak responses. Incorporating demographic factors such as biological sex into predictive models may elucidate important differences in symptom profiles that hold implications for disease detection.
Human epidermal growth factor (HER) -mediated signaling is critical in many cancers, including subsets of breast and lung cancer. HER family members signal via the phosphatidylinositide 3-kinase ...(PI3K) -AKT/protein kinase B-mammalian target of rapamycin (mTOR) cascade; mTOR activation is critical for the expression of multiple contributors to tumor growth and invasion. On the basis of preclinical data suggesting synergy of HER2 inhibition and mTOR inhibition in breast and lung cancer models, we conducted a phase I combination study of neratinib, a small-molecule irreversible pan-HER tyrosine kinase inhibitor, and temsirolimus, an mTOR inhibitor, in patients with advanced solid tumors.
This study enrolled patients to dosing combinations of neratinib and temsirolimus. The primary objective was to estimate the toxicity contour of the combination and establish recommended phase II doses.
Sixty patients were treated on 12 of 16 possible dosing combinations. Diarrhea was the most common drug-related (93%) and dose-limiting toxicity (DLT), constituting four of 10 DLTs. Dose-limiting grade 3 metabolic abnormalities were also observed. Other frequent drug-related toxicities included nausea, stomatitis (both 53%), and anemia (48%). Two maximum-tolerated dose combinations were identified: 200 mg of neratinib/25 mg of temsirolimus and 160 mg of neratinib/50 mg of temsirolimus. Responses were noted in patients with HER2-amplified breast cancer resistant to trastuzumab, HER2-mutant non-small-cell lung cancer, and tumor types without identified mutations in the HER-PI3K-mTOR pathway.
The combination of neratinib and temsirolimus was tolerable and demonstrated antitumor activity in multiple tumor types, warranting further evaluation.
Introduction
Obesity is an increasingly prevalent public health problem often associated with poorly controlled gastroesophageal reflux disease. Fundoplication has been shown to have limited ...long-term efficacy in patients with morbid obesity and does not address additional weight-related co-morbidities. Roux-en-Y gastric bypass (RYGB) is the gold standard operation for durable resolution of GERD in patients with obesity, and is also used as a salvage operation for GERD after prior foregut surgery. Surgeons report access to RYGB as surgical treatment for GERD is often limited by RYGB-specific benefit exclusions embedded within insurance policies, but the magnitude and scope of this problem is unknown.
Methods
A 9-item survey evaluating surgeon practice and experience with insurance coverage for RYGB for GERD was developed and piloted by a SAGES Foregut Taskforce working group. This survey was then administered to surgeon members of the SAGES Foregut Taskforce and to surgeons participating in the SAGES Bariatrics and/or Foregut Facebook groups.
Results
187 surgeons completed the survey. 89% reported using the RYGB as an anti-reflux procedure. 44% and 26% used a BMI of 35 kg/m
2
and 30 kg/m
2
respectively as cutoff for the RYGB. 89% viewed RYGB as the procedure of choice for GERD after bariatric surgery. 69% reported using RYGB to address recurrent reflux secondary to failed fundoplication. 74% of responders experienced trouble with insurance coverage at least half the time RYGB was offered for GERD, and 8% reported they were never able to get approval for RYGB for GERD indications in their patient populations.
Conclusion
For many patients, GERD and obesity are related diseases that are best addressed with RYGB. However, insurance coverage for RYGB for GERD is often limited by policies which run contrary to evidence-based medicine. Advocacy is critical to improve access to appropriate surgical care for GERD in patients with obesity.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Background Orthopaedic surgery has the lowest number of full-time faculty positions held by women, at 19%, with endowed chairs among the most coveted and advantageous. We examined the characteristics ...of endowed professors from the US top 100 orthopaedic academic centers and highest-funded musculoskeletal (MSK) researchers to determine if gender is associated with endowed professorship. Additionally, we sought to determine if gender is associated with increased NIH funding for top-performing musculoskeletal researchers. Methods Our primary study group included the top 100 orthopaedic academic centers defined by US News World Report and Doximity's rankings. Our secondary study group examined the top MSK researchers, defined as principal investigators, who received >$400,000 in annual NIH funding from 2018 to 2021. Orthopaedic departments included MSK researchers and subspecialties within orthopaedics and medicine. Publicly available sources were used to compile institutional, gender, H-index, citation number, and subspecialty data on endowed professors; statistical comparisons were calculated. Results Within the top 100 orthopaedic academic departments, 4674 faculty were identified. Seven hundred and thirty-three (15.68%) were identified as women, 3941 as men (84.32%). One hundred and ninety-four held endowed professorships; 13 were awarded to women (6.7%), and 185 (95.3%) were awarded to men, with a significant odds ratio (OR) of 2.95, favoring men. For MSK researchers, the OR increases to 11.4. Arthroplasty and sports had the highest numbers of endowments. Significant differences in H-index, publications, and graduation year were identified between men and women for top MSK researchers and orthopaedic-trained surgeons; however, these differences disappeared when considering heterogenous orthopaedic departments that included medicine subspecialties, plastic surgery, hand surgery, and neurosurgery. Additional gender differences were observed in endowment names, with awards commemorating 51.5% men, 7.2% women, and 34% families or groups. Conclusion Gender inequities at the endowment level are substantial, and there are very few women in musculoskeletal medicine to achieve endowments. Differences in H-index, publications, and graduation year between men and women MSK researchers and orthopaedic-trained surgeons, but not combined orthopaedic, PM&R, and medical subspecialty departments, suggest unique challenges in orthopaedic surgery environments and histories that may contribute to endowment disparity. Gender was not found to be associated with funding bias for top-performing musculoskeletal researchers.
Females have been historically excluded from biomedical research due in part to the documented presumption that results with male subjects will generalize effectively to females. This has been ...justified in part by the assumption that ovarian rhythms will increase the overall variance of pooled random samples. But not all variance in samples is random. Human biometrics are continuously changing in response to stimuli and biological rhythms; single measurements taken sporadically do not easily support exploration of variance across time scales. Recently we reported that in mice, core body temperature measured longitudinally shows higher variance in males than cycling females, both within and across individuals at multiple time scales.
Here, we explore longitudinal human distal body temperature, measured by a wearable sensor device (Oura Ring), for 6 months in females and males ranging in age from 20 to 79 years. In this study, we did not limit the comparisons to female versus male, but instead we developed a method for categorizing individuals as cyclic or acyclic depending on the presence of a roughly monthly pattern to their nightly temperature. We then compared structure and variance across time scales using multiple standard instruments.
Sex differences exist as expected, but across multiple statistical comparisons and timescales, there was no one group that consistently exceeded the others in variance. When variability was assessed across time, females, whether or not their temperature contained monthly cycles, did not significantly differ from males both on daily and monthly time scales.
These findings contradict the viewpoint that human females are too variable across menstrual cycles to include in biomedical research. Longitudinal temperature of females does not accumulate greater measurement error over time than do males and the majority of unexplained variance is within sex category, not between them.
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