Home Testing Research Articles

Quality improvement in a crisis: a qualitative study of experiences and lessons learned from the Irish National Ambulance Service response to the COVID-19 pandemic

ObjectivesThe COVID-19 pandemic has produced radical changes in international health services. In Ireland, the National Ambulance Service established a novel home and community testing service that was central to the...

End-user evaluation of a PSA home testing kit: survey results from UK men in the community

End-user evaluation of a PSA home testing kit: survey results from UK men in the community

Evolution of COVID-19 Testing and the Role of Rapid Antigen Testing in a Molecular-Focused World.

Evolution of COVID-19 Testing and the Role of Rapid Antigen Testing in a Molecular-Focused World.

The Avon Longitudinal Study of Parents and Children - A resource for COVID-19 research: Home-based antibody testing results, October 2020. An emphasis on self-screening at a population level.

The Avon Longitudinal Study of Parents and Children (ALSPAC) is a prospective population-based cohort study which recruited pregnant women in 1990-1992 and has followed these women, their partners (Generation 0; G0) and offspring (Generation 1; G1) ever since. The study reacted rapidly to the COVID-19 pandemic, deploying online questionnaires in March and May 2020. Home-based antibody tests and a further questionnaire were sent to 5220 participants during a two-week period of October 2020. 4.2% (n=201) of participants reported a positive antibody test (3.2% G0s [n=81]; 5.6% G1s [n=120]). 43 reported an invalid test, 7 did not complete and 3 did not report their result. Participants uploaded a photo of their test to enable validation: all positive tests, those where the participant could not interpret the result and a 5% random sample were manually checked against photos. We report 92% agreement (kappa=0.853). Positive tests were compared to additional COVID-19 status information: 58 (1.2%) participants reported a previous positive test, 73 (1.5%) reported that COVID-19 was suspected by a doctor, but not tested and 980 (20.4%) believed they had COVID-19 due to their own suspicions. Of those reporting a positive result on our antibody test, 55 reported that they did not think they had had COVID-19. Results from antibody testing and questionnaire data will be complemented by health record linkage and results of other biological testing- uniting Pillar testing data with home testing and self-report. Data have been released as an update to the original datasets released in July 2020. It comprises: 1) a standard dataset containing all participant responses to all three questionnaires with key sociodemographic factors and 2) as individual participant-specific release files enabling bespoke research across all areas supported by the study. This data note describes the antibody testing, associated questionnaire and the data obtained from it.

Durham University students’ experiences of asymptomatic COVID-19 testing: a qualitative study

ObjectivesTo evaluate the asymptomatic coronavirus testing programme at Durham University by exploring students’ barriers and facilitators to taking part and provide recommendations to improve the programme.DesignQualitative interviews.SettingOnline.Participants30 students enrolled at...

Association of COVID-19 mortality with politics and on-demand testing in 217\u2009U.S. counties

BackgroundPrevious research found increased COVID-19 spread associated with politics and on-demand testing but not in the same study. The objective of this study is to estimate the contribution of each corrected for the other and a variety of known risk factors.MethodsUsing data from 217 U.S. counties of more than 50,000 population where testing data were available in April, 2021, the associations of COVID-19 deaths with politics, testing and other risk factors were examined by Poisson and least squares regression.ResultsStatistical controls for 15 risk factors failed to eliminate the association of COVID mortality risk with percent of vote for Donald Trump in 2016 or negative tests per population. Each is independently predictive of increased mortality.ConclusionApparently, many people who test negative for the SARS-CoV-2 virus engage in activities that increase their risk, a problem likely to increase with the availability of home tests. There is no association of negative tests with the Trump vote but, according to polling data, Trump voters’ past resistance to public health recommendations has been extended to resistance to being vaccinated, threatening the goal of herd immunity.

Anesthesia disrupts distance, but not direction, of path integration memory

Solitary foraging insects, such as ants, maintain an estimate of the direction and distance to their starting location as they move away from it, in a process known as path integration. This estimate, commonly known as the "home vector," is updated continuously as the ant moves1-4 and is reset as soon as it enters its nest,5 yet ants prevented from returning to their nest can still use their home vector when released several hours later.6,7 This conjunction of fast update and long persistence of the home vector memory does not directly map to existing accounts of short-, mid-, and long-term memory;2,8-12 hence, the substrate of this memory remains unknown. Chill-coma anesthesia13-15 has previously been shown to affect associative memory retention in fruit flies14,16 and honeybees.9,17,18 We investigate the nature of path integration memory by anesthetizing ants after they have accumulated home vector information and testing if the memory persists on recovery. We show that after anesthesia the memory of the distance ants have traveled is degraded, but the memory of the direction is retained. We also show that this is consistent with models of path integration that maintain the memory in a redundant Cartesian coordinate system and with the hypothesis that chill-coma produces a proportional reduction of the memory, rather than a subtractive reduction or increase of noise. The observed effect is not compatible with a memory based on recurrent circuit activity and points toward an activity-dependent molecular process as the basis of path integration memory.

Are we allowed to visit now? Concerns and issues surrounding vaccination and infection risks in UK care homes during COVID-19.

Backgroundvaccination uptake in the UK and increased care home testing are likely affecting care home visitation. With scant scientific evidence to date, the aim of this longitudinal qualitative study was to explore the impact of both (vaccination and testing) on the conduct and experiences of care home visits.Methodsfamily carers of care home residents with dementia and care home staff from across the UK took part in baseline (October/November 2020) and follow-up interviews (March 2021). Public advisers were involved in all elements of the research. Data were analysed using thematic analysis.Resultsacross 62 baseline and follow-up interviews with family carers (n = 26; 11) and care home staff (n = 16; 9), five core themes were developed: delayed and inconsistent offers of face-to-face visits; procedures and facilitation of visits; variable uptake of the COVID-19 vaccine; misinformation, education and free choice; frustration and anger among family carers. The variable uptake in staff, compared to family carers, was a key factor seemingly influencing visitation, with a lack of clear guidance leading care homes to implement infection control measures and visitation rights differently.Conclusionswe make five recommendations in this paper to enable improved care home visitation in the ongoing, and in future, pandemics. Visits need to be enabled and any changes to visiting rights must be used as a last resort, reviewed regularly in consultation with residents and carers and restored as soon as possible as a top priority, whilst more education needs to be provided surrounding vaccination for care home staff.

The Cambridge Cognitive and Psychiatric Assessment Kit (CamCOPS): A Secure Open-Source Client-Server System for Mobile Research and Clinical Data Capture.

CamCOPS is a free, open-source client–server system for secure data capture in the domain of psychiatry, psychology, and the clinical neurosciences. The client is a cross-platform C++ application, suitable for mobile and offline (disconnected) use. It allows touchscreen data entry by subjects/patients, researchers/clinicians, or both together. It implements a large and extensible range of tasks, from simple questionnaires to complex animated tasks. The client uses encrypted data storage and sends data via an encrypted network connection to a CamCOPS server. Individual institutional users set up and run their own CamCOPS server, so no data is transferred outside the hosting institution's control. The server, written in Python, provides clinically oriented and research-oriented views of tasks, including the tracking of changes over time. It provides an audit trail, export facilities (such as to an institution's primary electronic health record system), and full structured data access subject to authorization. A single CamCOPS server can support multiple research/clinical groups, each having its own identity policy (e.g., fully identifiable for clinical use; de-identified/pseudonymised for research use). Intellectual property rules regarding third-party tasks vary and CamCOPS has several mechanisms to support compliance, including for tasks that may be permitted to some institutions but not others. CamCOPS supports task scheduling and home testing via a simplified user interface. We describe the software, report local information governance approvals within part of the UK National Health Service, and describe illustrative clinical and research uses.

Feasibility of At-Home Vibrotactile Data Collection in Children and Adolescents: Study of Mild Traumatic Brain Injury

Remote testing has become a desireable option as it helps reduce participant burden, can be more convenient and enables longitudinal data collection to track symptom recovery. Recently, advances in testing have enabled researchers to test somatosensory processing and brain function. Using tactile testing modalities such as vibrotactile stimulation to the fingertips can provide information about cortical inhibition, for example, without the need for invasive testing procedures. In the current manuscript, we present our initial experience for ‘at home’ tactile testing. We demonstrate 1) it is possible to develop an ‘at home’ testing battery with multiple tasks that is comparable to ‘in lab’ testing; and 2) it is feasible to collect this data remotely and repeatedly to monitor longitudinal changes.
 Participants included pediatric concussion patients and orthopedic injury (OI) controls, 8-18 years of age at time of participation, and were recruited ~10 days after injury. Testing was conducted on a 2-digit vibrotactile stimulator hand-held device and was based on previously used protocols. Stimulation was delivered to the left index and middle finger. Data quality of tasks was visually inspected to ensure data followed a pattern of converging values of thresholds over time. A total of 19 participants were recruited in this study; 11 concussion and 8 OI. Participants in the concussion group were 12.8 ± 2.2 years old (36.4% female) and participants in the OI group were 11.6 ± 2.5 years old (57.1% female) at the time of injury. Results from paired sample t-tests comparing task performance did not detect significant differences between the data collected from the home session and at the lab visit for the concussion group.
 Our results demonstrate that vibrotactile sensory testing can provide a non-invasive, objective measure of central nervous system functioning without relying on subjective questionnaires. This work demonstates it is possible to perform this testing remotely. Our data with children and adolescents demonstrates they are capable of completing these tasks at home; we therefore expect this at home testing protocol could easily be administered in other populations.

Home pregnancy test use and timing of pregnancy confirmation among people seeking health care

Understanding the timing of pregnancy suspicion and confirmation, including the role of home pregnancy tests, can facilitate earlier entry into pregnancy-related care and identify individuals likely to be impacted by gestation-based abortion restrictions. We use data from 259 pregnant individuals participating in a cross-sectional survey at 8 primary and reproductive health care clinics in 6 U.S. states (2016-2017). We use regression models to identify differences in utilization of HPTs, barriers to use, and to compare gestational duration at pregnancy confirmation. Three-quarters (74%) of respondents took a home pregnancy test as the first step in confirming pregnancy; this figure was lower among adolescents versus young adults (65 vs 81%, p = 0.01). Two-thirds (64%) reported delays in home testing, higher among adolescents (85%). People taking a test at home confirmed pregnancy 10 days earlier than those first testing at a clinic (41.3 vs 51.8 days gestation, p = 0.02). Those that did not test at home cited concerns about test accuracy (42%) and difficulties accessing one (26%). While overall 21% confirmed pregnancy at ≥7 weeks gestation, and 35% at ≥6 weeks, confirmation at ≥7 weeks was higher among adolescents versus young adults (47 vs 13%, p = 0.001), Latina versus white women (28 vs 11%, p = 0.02), food insecure versus secure women (28 vs 17%, p = 0.06), and people with unplanned versus planned/mistimed pregnancies (25 vs 13%, p = 0.07). Home pregnancy testing is common and associated with earlier pregnancy confirmation. Still, barriers to at-home testing are evident, particularly among adolescents. Efforts to expand access to home pregnancy tests and increase knowledge about their accuracy may be impactful in increasing utilization. While at home pregnancy testing is common and facilitates earlier confirmation of pregnancy, one in 5 confirm pregnancy at 7 weeks gestation or later (and one in 3 do so at 6 weeks or later). Gestational bans in the first trimester will disproportionately prevent young people, people of color, and those living with food insecurity from being able to access abortion.

Longitudinal analysis of sociodemographic, clinical and therapeutic factors of HIV-infected individuals in Kinshasa at antiretroviral therapy initiation during 2006-2017.

BackgroundThe benefits of antiretroviral therapy (ART) underpin the recommendations for the early detection of HIV infection and ART initiation. Late initiation (LI) of antiretroviral therapy compromises the benefits of ART both individually and in the community. Indeed, it promotes the transmission of infection and higher HIV-related morbidity and mortality with complicated and costly clinical management.This study aims to analyze the evolutionary trends in the median CD4 count, the median time to initiation of ART, the proportion of patients with advanced HIV disease at the initiation of ART between 2006 and 2017 and their factors.Methods and findingsHIV-positive adults (≥ 16 years old) who initiated ART between January 1, 2006 and December 31, 2017 in 25 HIV care facilities in Kinshasa, the capital of DRC, were eligible. The data were processed anonymously. LI is defined as CD4≤350 cells/μl and/or WHO clinical stage III or IV and advanced HIV disease (AHD), as CD4≤200 cells/μl and/or stage WHO clinic IV. Factors associated with advanced HIV disease at ART initiation were analyzed, irrespective of year of enrollment in HIV care, using logistic regression models.A total of 7278 patients (55% admitted after 2013) with an average age of 40.9 years were included. The majority were composed of women (71%), highly educated women (68%) and married or widowed women (61%). The median CD4 was 213 cells/μl, 76.7% of patients had CD4≤350 cells/μl, 46.1% had CD4≤200 cells/μl, and 59% of patients were at WHO clinical stages 3 or 4. Men had a more advanced clinical stage (p <0.046) and immunosuppression (p<0.0007) than women.Overall, 70% of patients started ART late, and 25% had AHD. Between 2006 and 2017, the median CD4 count increased from 190 cells/μl to 331 cells/μl (p<0.0001), and the proportions of patients with LI and AHD decreased from 76% to 47% (p< 0.0001) and from 18.7% to 8.9% (p<0.0001), respectively.The median time to initiation of ART after screening for HIV infection decreased from 40 to zero months (p<0.0001), and the proportion of time to initiation of ART in the month increased from 39 to 93.3% (p<0.0001) in the same period.The probability of LI of ART was higher in married couples (OR: 1.7; 95% CI: 1.3–2.3) (p<0.0007) and lower in patients with higher education (OR: 0.74; 95% CI: 0.64–0.86) (p<0.0001).ConclusionDespite increasingly rapid treatment, the proportions of LI and AHD remain high. New approaches to early detection, the first condition for early ART and a key to ending the HIV epidemic, such as home and work HIV testing, HIV self-testing and screening at the point of service, must be implemented.

Automatic Sleep Staging in Children with Sleep Apnea using Photoplethysmography and Convolutional Neural Networks.

Sleep staging is of paramount importance in children with suspicion of pediatric obstructive sleep apnea (OSA). Complexity, cost, and intrusiveness of overnight polysomnography (PSG), the gold standard, have led to the search for alternative tests. In this sense, the photoplethysmography signal (PPG) carries useful information about the autonomous nervous activity associated to sleep stages and can be easily acquired in pediatric sleep apnea home tests with a pulse oximeter. In this study, we use the PPG signal along with convolutional neural networks (CNN), a deep-learning technique, for the automatic identification of the three main levels of sleep: wake (W), rapid eye movement (REM), and non-REM sleep. A database of 366 PPG recordings from pediatric OSA patients is involved in the study. A CNN architecture was trained using 30-s epochs from the PPG signal for three-stage sleep classification. This model showed a promising diagnostic performance in an independent test set, with 78.2% accuracy and 0.57 Cohen's kappa for W/NREM/REM classification. Furthermore, the percentage of time in wake stage obtained for each subject showed no statistically significant differences with the manually scored from PSG. These results were superior to the only state-of-the-art study focused on the analysis of the PPG signal in the automated detection of sleep stages in children suffering from OSA. This suggests that CNN can be used along with PPG recordings for sleep stages scoring in pediatric home sleep apnea tests.

A novel proteomic-based screening method for ovarian cancer using cervicovaginal fluids: A window into the abdomen

ObjectiveOur objective is to develop a site-specific proteomic-based screening test for ovarian cancer(OC) using the mucus of the cervix and vagina and evaluate a potential means for home testing. MethodsCervicovaginal fluid samples were obtained from ovarian cancer and normal control patients for LC-mass spectrometry(MS) proteomic evaluation. Statistical modeling determined the protein panel with the highest penetrance across ovarian cancer samples. A subcohort of patients consented to provide self-collected vaginal samples at home with questionnaire on feasibility. Cohen's kappa methodology was utilized to determine agreement between physician-collected and patient-collected samples. ResultsA total of 83 consecutive patient samples were collected prospectively (33 ovarian cancer & 50 controls). Thirty patients consented for self-collection. Using LC-MS, 30 peptides demonstrated independent statistical significance for detecting ovarian cancer. Using statistical modeling, the protein panel that determined the best predictor for detecting OC formed a “fingerprint” consisting of 5 proteins: serine proteinase inhibitor A1; periplakin; profilin1; apolipoprotein A1; and thymosin beta4-like protein. These peptides demonstrated a significant increase probability of detecting ovarian cancer with the ROC curve having an AUC of 0.86 (p = 0.00001). Physician-collected and patient-collected specimens demonstrated moderate agreement with kappa average of 0.6 with upper bound of 0.75. ConclusionsUsing novel site-specific collection methods, we identified an OC “fingerprint” with adequate sensitivity and specificity to warrant further evaluation in a larger cohort. Agreement of physician-collected and patient-collected samples were encouraging and could improve access to screening with a home self-collection if this screening test is validated in future studies.

A randomized controlled trial of an mHealth intervention for increasing access to HIV testing and care among young cisgender men and transgender women: the mLab App study protocol

BackgroundThe number of youth living with HIV in the United States (US) continues to rise, and racial, ethnic, and sexual minority youth including young men who have sex with men (YMSM) and young transgender women (YTGW) bear a disproportionate burden of the HIV epidemic. Due to social and healthcare system factors, many YMSM and YTGW do not seek HIV testing services and are therefore less likely to be aware that they are infected. Mobile health technology (mHealth) has the ability to increase uptake of HIV testing among these populations. Thus, the mLab App—which combines HIV prevention information with a mobile phone imaging feature for interpreting at-home HIV test results—was developed to improve testing rates and linkage to care among Black, Latino, and other YMSM and YTGW living in New York City and Chicago and their surrounding areas.MethodsThis study is a three-arm randomized controlled trial among YMSM and YTGW aged 18–29 years. Participants are randomized to either the mLab App intervention including HIV home test kits and standard of preventive care, standard of preventive care only, or HIV home test kits and standard of preventive care only.DiscussionmHealth technology used for HIV prevention is capable of delivering interventions in real-time, which creates an opportunity to remotely reach users across the country to strengthen their HIV care continuum engagement and treatment outcomes. Specifically during the COVID-19 pandemic, mHealth technology combined with at-home testing may prove to be essential in increasing HIV testing rates, especially among populations at high-risk or without regular access to HIV testing.Trial registrationThis trial was registered with Clinicaltrials.gov (NCT03803683) on January 14, 2019.

Barriers, facilitators and pathways of a lung cancer screening (LCS) programme: COBELT co-design

Abstract Lung cancer (LC) is one of the most common causes of cancer death globally. Adults aged 55+, (ex)-smokers and living in areas of deprivation are at greater risk from lung cancer. Leading to a 20% decrease in mortality rates, screening with Low Dose CT (LDCT) is a promising means of detecting LC early. Autoantibody biomarker blood tests may play a role in identifying people suitable for LDCT screening, forming a national LCS programme. To increase the likelihood of the success of such a programme, suitable ways of providing the service must firstly be identified. A 2-phase co-design process, with 2 population groups. Group 1-Aged 55+, (ex)-smoker, high deprivation (N = 39). Group 2-Health and community professionals (N = 16). Phase 1: Interviews and focus groups. Conversations focussed on barriers, facilitators and potential pathways for the uptake and provision of a biomarker blood test and LCS. Phase 2: Interactive surveys (offline/online), focussing on the prioritisation of key barriers and solution generation. Qualitative data was transcribed and analysed using thematic analysis. Descriptive statistics were generated for quantitative data. Phase 1 identified key barriers, facilitators and pathways for uptake and provision. Service users indicated options for uptake and a means to embed the programme in the community as essential. From the perspective of providers, capacity and time for provision were key. Phase 2 found a home test kit was the preferred method of blood test for service users (independently or with assistance). Service providers leaned towards provision via venesection. Barriers were ranked by service users, the most dominant barrier was Fear of test result. Working in a collaborative manner has led to the identification of new knowledge and insights regarding the best means to target a future LCS programme to those who may benefit most. Future implementation of such a programme should consider the results from this study. This is a CSO funded project. Key messages This process has illuminated key barriers, facilitators and pathway options that could improve the implementation of a LCS programme, using an autoantibody blood test to identify LDCT candidates. Measures to overcome barriers from both the perspective of the service users and providers are necessary to ensure the success of the LCS programme.

Chilblains during lockdown are associated with household exposure to SARS-CoV-2: a multicentre case–control study

ObjectivesDuring the COVID-19 pandemic, numerous cases of chilblains have been reported. However, in most cases, RT-PCR or serology did not confirm SARS-CoV-2 infection. Hypotheses have been raised about an interferon-mediated immunological response to SARS-CoV-2, leading to effective clearance of the SARS-CoV-2 without the involvement of humoral immunity. Our objective was to explore the association between chilblains and exposure to SARS-CoV-2. MethodsIn this multicentre case–control study, cases were the 102 individuals referred to five referral hospitals for chilblains occurring during the first lockdown (March to May 2020). Controls were recruited from healthy volunteers' files held by the same hospitals. All members of their households were included, resulting in 77 case households (262 individuals) and 74 control households (230 individuals). Household exposure to SARS-CoV-2 during the first lockdown was categorized as high, intermediate or low, using a pre-established algorithm based on individual data on symptoms, high-risk contacts, activities outside the home and RT-PCR testing. Participants were offered a SARS-CoV-2 serological test. ResultsAfter adjustment for age, the association between chilblains and viral exposure was estimated at OR 3.3, 95% CI (1.4–7.3) for an intermediate household exposure, and 6.9 (2.5–19.5) for a high household exposure to SARS-CoV-2. Out of 57 case households tested, six (11%) had positive serology for SARS-CoV-2, whereas all control households tested (n = 50) were seronegative (p = 0.03). The effect of potential misclassification on exposure has been assessed in a bias analysis. DiscussionThis case–control study demonstrates the association between chilblains occurring during the lockdown and household exposure to SARS-CoV-2.

Acceptability, Usability, and Performance of Lateral Flow Immunoassay Tests for Severe Acute Respiratory Syndrome Coronavirus 2 Antibodies: REACT-2 Study of Self-Testing in Nonhealthcare Key Workers.

BackgroundSeroprevalence studies are essential to understand the epidemiology of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Various technologies, including laboratory assays and point-of-care self-tests, are available for antibody testing. The interpretation of seroprevalence studies requires comparative data on the performance of antibody tests.MethodsIn June 2020, current and former members of the United Kingdom police forces and fire service performed a self-test lateral flow immunoassay (LFIA), had a nurse-performed LFIA, and provided a venous blood sample for enzyme-linked immunosorbent assay (ELISA). We present the prevalence of antibodies to SARS-CoV-2 and the acceptability and usability of self-test LFIAs, and we determine the sensitivity and specificity of LFIAs compared with laboratory ELISA.ResultsIn this cohort of 5189 current and former members of the police service and 263 members of the fire service, 7.4% (396 of 5348; 95% confidence interval [CI], 6.7–8.1) were antibody positive. Seroprevalence was 8.9% (95% CI, 6.9–11.4) in those under 40 years, 11.5% (95% CI, 8.8–15.0) in those of nonwhite ethnicity, and 7.8% (95% CI, 7.1–8.7) in those currently working. Self-test LFIA had an acceptability of 97.7% and a usability of 90.0%. There was substantial agreement between within-participant LFIA results (kappa 0.80; 95% CI, 0.77–0.83). The LFIAs had a similar performance: compared with ELISA, sensitivity was 82.1% (95% CI, 77.7–86.0) self-test and 76.4% (95% CI, 71.9–80.5) nurse-performed with specificity of 97.8% (95% CI, 97.3–98.2) and 98.5% (95% CI, 98.1–98.8), respectively.ConclusionsA greater proportion of this nonhealthcare key worker cohort showed evidence of previous infection with SARS-CoV-2 than the general population at 6.0% (95% CI, 5.8–6.1) after the first wave in England. The high acceptability and usability reported by participants and similar performance of self-test and nurse-performed LFIAs indicate that the self-test LFIA is fit for purpose for home testing in occupational and community prevalence studies.

SPIROMETRY IN COVID-19 PNEUMONIA PATIENTS ON CONTINUOUS REMOTE PATIENT MONITORING

TOPIC: Chest Infections TYPE: Original Investigations PURPOSE: The long-term implications of COVID-19 pneumonia remain under investigation. Many of those that suffered from the illness continue to experience symptoms weeks to months following their initial recovery. We assessed patients with COVID-19 pneumonia who were discharged from the hospital to an outpatient-based continuous remote patient monitoring (CRPM) program. METHODS: Forty hospitalized patients diagnosed with COVID-19 pneumonia between the ages of 28 and 78 were referred to a designated CRPM team for evaluation and enrollment in a remote monitoring pilot program prior to discharge between the dates of December 2020 and April 2021. Enrolled patients were issued an FDA-approved biophysiologic monitoring device, digital tablet for video teleconferencing, and an in-home Wi-Fi/Mobile Data hub following nursing-led training prior to departing the medical facility. The provided equipment was capable of continuous, near-real time monitoring of SpO2, heart rate, respiration rate, surface/axillary temperature, and mobility data;intermittent data was also collected via a linked automatic blood pressure cuff and portable spirometer. Patients were monitored 24 hours, 7 days per week during their enrollment by dedicated tele-health nursing staff and received serial automated prompts to perform blood pressure assessments and spirometry using the included equipment. Initial and final pulse oximetry and spirometric data was reviewed, consisting of forced vital capacity (FVC), forced expiratory volume at one second (FEV1), FEV1/FVC ratio. Patients were disenrolled from the program in the following circumstances: the patient was readmitted to the hospital, the patient chose to disenroll themselves, or the supervising physician determined the patient to be stable for ≥ 72 hours. RESULTS: Forty patients enrolled in the pilot program. Twenty-seven of these patients completed initial and final spirometry and pulse oximetry prior to program discharge. Total days of enrollment were on average 31 ± 25 days. Initial pulse oximetric data returned with a mean of 95 ± 1.6%. Of note, 13 of the 27 patients required supplemental oxygen following hospital discharge. Initial spirometric data for these individuals returned with mean values for FVC (L) of 1.77 ± 0.82, FEV1(L) of 1.22 ± 0.47, and FEV1/FVC of 75 ± 20%. Prior to program disenrollment, mean pulse oximetry was measured at 97 ± 1.9% with only 2 of the 27 patients continuing to require oxygen. Final spirometric data returned with mean values for FVC (L) of 2.61 ± 1.16, FEV1(L) of 1.89 ± 0.72, and FEV1/FVC of 78 ± 19%. CONCLUSIONS: This study evaluated early and late home-tested spirometry and pulse oximetry in patients with COVID-19 pneumonia discharged from the hospital to a CRPM pilot program. Nearly half of the patients (48%) required supplemental oxygen at the time of discharge with only 7.4% requiring oxygen once discharged from the pilot program. Spirometric data indicated an increase of 47.5% in FVC, an increase of 55% for FEV1, an increase of 4.1% in FEV1/FVC between initial and final testing. Correlation with in-lab spirometry testing and percent predicted values will aid in determining the accuracy of the deficits identified on home testing. CLINICAL IMPLICATIONS: This study provides insight into the rate of lung function recovery in hospitalized COVID-19 pneumonia patients, and introduces a novel method to closely monitor recovering patients on an outpatient-basis. DISCLOSURES: No relevant relationships by Sean Hipp, source=Web Response No relevant relationships by Theresa Kinshella, source=Web Response No relevant relationships by Kevin Loudermilk, source=Web Response Speaker/Speaker's Bureau relationship with Janssen Please note: $1001 - $5000 Added 12/02/2020 by Michael Morris, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with GSK Please note: $1001 - $5000 Added 12/02/2020 by Michael Morris, source=Web Response, value=Honoraria No relevant relationships by Caitlin Smith, ource=Web Response No relevant relationships by Robert Walter, source=Web Response No relevant relationships by Daniel Yourk, source=Web Response

Celiac Disease.

Celiac Disease.