Prediction of deterioration from COVID-19 in patients in skilled nursing facilities using wearable and contact-free devices: a feasibility study

Background and RationaleApproximately 35% of all COVID-19 deaths occurred in Skilled Nursing Facilities (SNFs). In a healthy general population, wearables have shown promise in providing early alerts for actionable interventions during the pandemic. We tested this promise in a cohort of SNFs patients diagnosed with COVID-19 and admitted for post-acute care under quarantine. We tested if 1) deployment of wearables and contact-free biosensors is feasible in the setting of SNFs and 2) they can provide early and actionable insights into deterioration. MethodsThis prospective clinical trial has been IRB-approved (NCT04548895). We deployed two commercially available devices detecting continuously every 2-3 minutes heart rate (HR), respiratory rate (RR) and uniquely providing the following biometrics: 1) the wrist-worn bracelet by Biostrap yielded continuous oxygen saturation (O2Sat), 2) the under-mattress ballistocardiography sensor by Emfit tracked in-bed activity, tossing, and sleep disturbances. Patients also underwent routine monitoring by staff every 2-4 h. For death outcomes, cases are reported due to the small sample size. For palliative care versus at-home discharges, we report mean{+/-}SD at p<0.05. ResultsFrom 12/2020 - 03/2021, we approached 26 PCR-confirmed SarsCoV2-positive patients at two SNFs: 5 declined, 21 were enrolled into monitoring by both sensors (female=13, male=8; age 77.2{+/-}9.1). We recorded outcomes as discharged to home (8, 38%), palliative care (9, 43%) or death (4, 19%). The O2Sat threshold of 91% alerted for intervention. Biostrap captured hypoxic events below 91% nine times as often as the routine intermittent pulse oximetry. In the patient deceased, two weeks prior we observed a wide range of O2Sat values (65-95%) captured by the Biostrap device and not noticeable with the routine vital sign spot checks. In this patient, the Emfit sensor yielded a markedly reduced RR (7/min) in contrast to 18/min from two routine spot checks performed in the same period of observation as well as compared to the seven patients discharged home over a total of 86 days of monitoring (RR 19{+/-} 4). Among the patients discharged to palliative care, a total of 76 days were monitored, HR did not differ compared to the patients discharged home (68{+/-}8 vs 70{+/-}7 bpm). However, we observed a statistically significant reduction of RR at 16{+/-}4/min as well as the variances in RR (10{+/-}6 vs 19{+/-}4/min vs16{+/-}13) and activity of palliative care patients vs. patients discharged home. Conclusion/DiscussionWe demonstrate that wearables and under-mattress sensors can be integrated successfully into the SNF workflows and are well tolerated by the patients. Moreover, specific early changes of oxygen saturation fluctuations and other biometrics herald deterioration from COVID-19 two weeks in advance and evaded detection without the devices. Wearable devices and under-mattress sensors in SNFs hold significant potential for early disease detection.

In-process rheometry as a PAT tool for hot melt extrusion.

Real time measurement of melt rheology has been investigated as a Process Analytical Technology (PAT) to monitor hot melt extrusion of an Active Pharmaceutical Ingredient (API) in a polymer matrix. A developmental API was melt mixed with a commercial copolymer using a heated twin screw extruder at different API loadings and set temperatures. The extruder was equipped with an instrumented rheological slit die which incorporated three pressure transducers flush mounted to the die surface. Pressure drop measurements within the die at a range of extrusion throughputs were used to calculate rheological parameters, such as shear viscosity and exit pressure, related to shear and elastic melt flow properties, respectively. Results showed that the melt exhibited shear thinning behavior whereby viscosity decreased with increasing flow rate. Increase in drug loading and set extrusion temperature resulted in a reduction in melt viscosity. Shear viscosity and exit pressure measurements were found to be sensitive to API loading. These findings suggest that this technique could be used as a simple tool to measure material attributes in-line, to build better overall process understanding for hot melt extrusion.

Latitudinal variation of freeze tolerance in intertidal marine snails of the genus Melampus (Gastropoda: Ellobiidae).

Abstract Low temperatures limit the poleward distribution of many species such that the expansion of geographic range can only be accomplished via evolutionary innovation. We have tested for physiological differences among closely related species to determine whether their poleward latitudinal ranges are limited by tolerance to cold. We measured lower temperature tolerance (LT50) among a group of intertidal pulmonate snails from six congeneric species and nine locales. Differences in tolerance are placed in the context of a molecular phylogeny based on one mitochondrial (cytochrome oxidase subunit I) and two nuclear (histone 3 and a mitochondrial phosphate carrier protein) markers. Temperate species from two separate lineages had significantly lower measures of LT50 than related tropical species. Range differences within the temperate zone, however, were not explained by LT50. These results show that multiple adaptations to cold and freezing may have enabled range expansions out of the tropics in Melampus. However, northern range limits within temperate species are not governed by cold tolerance alone.

A controlled comparison of family versus individual therapy for adolescents with anorexia nervosa.

OBJECTIVE: To compare the effectiveness of behavioral family systems therapy (BFST) with that of ego-oriented individual therapy (EOIT) as treatments for adolescents with anorexia nervosa. METHOD: Thirty-seven adolescents meeting DSM-III-R criteria for anorexia nervosa were randomly assigned to receive BFST or EOIT, in addition to a common medical and dietary regimen. In BFST, the family was seen conjointly, the parents were placed in control of the adolescent's eating, distorted beliefs were targeted through cognitive restructuring, and strategic/behavioral interventions were used to change family interactions. In EOIT, the adolescent was seen individually, with an emphasis on building ego strength and uncovering the dynamics blocking eating; parents were seen collaterally. Measures administered before, after, and at 1-year follow-up tapped body mass index, menstruation, eating attitudes, ego functioning, depression, and family interactions. RESULTS: BFST produced greater weight gain and higher rates of resumption of menstruation than EOIT. Both treatments produced comparably large improvements in eating attitudes, depression, and eating-related family conflict, but very few changes occurred on ego functioning. CONCLUSIONS: BFST and EOIT proved to be effective treatments for adolescents with anorexia nervosa, but BFST produced a faster return to health.

Treatment of eating disorders in children and adolescents.

Anorexia nervosa and bulimia nervosa are expressed differently in children and adolescents than in adults. Consequently, diagnostic procedures and multidisciplinary treatments need to be tailored to the unique developmental, medical, nutritional, and psychological needs of children and adolescents with eating disorders. This paper reviews current research outlining the differences between child, adolescent, and adult eating disorders. Research is then reviewed concerning the effectiveness of hospitalization, partial hospitalization, individual dynamic therapy, cognitive-behavioral therapy, interpersonal therapy, family therapy, and medication for treating anorexia nervosa, bulimia nervosa, and related eating disorders in children and adolescents. Specific recommendations are made for practitioners to tailor these treatments to their eating-disordered child and adolescent patients, following a stepped-care, decision-tree model of intervention that takes into account the effectiveness, cost, and intrusiveness of the interventions.

Treatment impressions and termination experiences with borderline patients.

This study investigates the treatment impressions and termination experiences of faculty clinicians treating individuals with borderline personality disorder. Thirty-nine clinicians (28 psychiatrists and 11 psychologists) completed the Treatment of Borderlines Survey. Results indicated that individual psychotherapy was perceived to be the most valuable treatment modality, that the majority of respondents work towards character change but do not expect "normal," the most common reported reasons for patient termination were "patient does not see the purpose of treatment" and "patient terminates through acting-out behaviors," and a slight majority reported that they had "cured" at least some of their borderline patients. The most common concerns experienced during the termination process included regression, acting-out, and self-destructive behavior. There were very few differences in the perceptions and treatment experiences between psychiatrists and psychologists. These results provide empirical support for claims made in the clinical literature on treating borderline patients.

Multifactorial assessment of bulimia nervosa.

We investigated a multifactorial approach to the assessment of bulimia nervosa by means of hierarchical factor analysis. Two hundred forty-five bulimia nervosa patients and 68 patients with either anorexia nervosa or eating disorders not otherwise specified were administered a self-report battery that was organized into 21 dimensions relevant to eating disorder patients. When dimensions from this battery were subjected to hierarchical factor analysis, support for bulimia nervosa as a unique diagnostic category was obtained. However, the emergence of 3 secondary factors and 6 primary factors suggests that bulimia nervosa can also be described more complexly. The emergence of a multifactorial model of bulimia nervosa that incorporates several existing undimensional models suggests the potential for both divergent and complicated clinical presentation in bulimia nervosa patients.