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1.
Cancer Med ; 12(8): 9902-9911, 2023 04.
Article in English | MEDLINE | ID: covidwho-2239746

ABSTRACT

BACKGROUND: This study examines the impact that the COVID-19 pandemic has had on computed tomography (CT)-based oncologic imaging utilization. METHODS: We retrospectively analyzed cancer-related CT scans during four time periods: pre-COVID (1/5/20-3/14/20), COVID peak (3/15/20-5/2/20), post-COVID peak (5/3/20-12/19/20), and vaccination period (12/20/20-10/30/21). We analyzed CTs by imaging indication, setting, and hospital type. Using percentage decrease computation and Student's t-test, we calculated the change in mean number of weekly cancer-related CTs for all periods compared to the baseline pre-COVID period. This study was performed at a single academic medical center and three affiliated hospitals. RESULTS: During the COVID peak, mean CTs decreased (-43.0%, p < 0.001), with CTs for (1) cancer screening, (2) initial workup, (3) cancer follow-up, and (4) scheduled surveillance of previously treated cancer dropping by 81.8%, 56.3%, 31.7%, and 45.8%, respectively (p < 0.001). During the post-COVID peak period, cancer screenings and initial workup CTs did not return to prepandemic imaging volumes (-11.4%, p = 0.028; -20.9%, p = 0.024). The ED saw increases in weekly CTs compared to prepandemic levels (+31.9%, p = 0.008), driven by increases in cancer follow-up CTs (+56.3%, p < 0.001). In the vaccination period, cancer screening CTs did not recover to baseline (-13.5%, p = 0.002) and initial cancer workup CTs doubled (+100.0%, p < 0.001). The ED experienced increased cancer-related CTs (+75.9%, p < 0.001), driven by cancer follow-up CTs (+143.2%, p < 0.001) and initial workups (+46.9%, p = 0.007). CONCLUSIONS AND RELEVANCE: The pandemic continues to impact cancer care. We observed significant declines in cancer screening CTs through the end of 2021. Concurrently, we observed a 2× increase in initial cancer workup CTs and a 2.4× increase in cancer follow-up CTs in the ED during the vaccination period, suggesting a boom of new cancers and more cancer examinations associated with emergency level acute care.


Subject(s)
COVID-19 , Neoplasms , Humans , COVID-19/epidemiology , COVID-19/prevention & control , Pandemics/prevention & control , Retrospective Studies , Tomography, X-Ray Computed , Neoplasms/diagnostic imaging , Neoplasms/epidemiology , Vaccination , Emergency Service, Hospital
2.
Clin Infect Dis ; 2022 Jun 28.
Article in English | MEDLINE | ID: covidwho-2236091

ABSTRACT

BACKGROUND: Early antiviral therapy was effective in the treatment of COVID-19. We assessed the efficacy and safety of combined interferon beta-1b and remdesivir treatment in hospitalized COVID-19 patients. METHODS: We conducted a multicentre, prospective open-label, randomized-controlled trial involving high-risk adults hospitalized for COVID-19. Patients were randomly assigned to a 5-day interferon beta-1b 16 million units daily and remdesivir 200mg loading on day 1 followed by 100mg daily on day 2 to 5 (combination-group), or to remdesivir only of similar regimen (control-group) (1:1). The primary end-point was the time to complete alleviation of symptoms (NEWS2 = 0). RESULTS: Two-hundred and twelve patients were enrolled. The median days of starting treatment from symptom-onset was 3 days. The median age was 65 years and 159 patients (75%) had chronic disease. The baseline demographics were similar. There was no mortality. For the primary-endpoint, the combination-group was significantly quicker to NEWS2 = 0 (4 versus 6.5 days; hazard-ratio [HR],6.59; 95% confidence-interval [CI],6.1-7.09; p < 0.0001) when compared to the control-group. For the secondary endpoints, the combination-group was quicker to negative NPS VL (6 versus 8 days; HR,8.16; 95% CI,7.79-8.52; p < 0.0001) and develop seropositive IgG (8 versus 10 days; HR,10.78; 95% CI,9.98-11.58; p < 0.0001). All adverse events resolved upon follow-up. Combination group (HR,4.1 95%CI,1.9-8.6, p < 0.0001), was the most significant independent factor associated with NEWS2 = 0 on day 4. CONCLUSIONS: Early treatment with interferon beta-1b and remdesivir was safe and better than remdesivir only in alleviating symptoms, shorten viral shedding and hospitalization with earlier seropositivity in high-risk COVID-19 patients.

3.
JCO Clin Cancer Inform ; 6: e2100160, 2022 03.
Article in English | MEDLINE | ID: covidwho-2114951

ABSTRACT

PURPOSE: The COVID-19 pandemic created an imperative to re-examine the role of telehealth in oncology. We studied trends and disparities in utilization of telehealth (video and telephone visits) and secure messaging (SM; ie, e-mail via portal/app), before and during the pandemic. METHODS: Retrospective cohort study of hematology/oncology patient visits (telephone/video/office) and SM between January 1, 2019, and September 30, 2020, at Kaiser Permanente Northern California. RESULTS: Among 334,666 visits and 1,161,239 SM, monthly average office visits decreased from 10,562 prepandemic to 1,769 during pandemic, telephone visits increased from 5,114 to 8,663, and video visits increased from 40 to 4,666. Monthly average SM increased from 50,788 to 64,315 since the pandemic began. Video visits were a significantly higher fraction of all visits (P < .01) in (1) younger patients (Generation Z 48%, Millennials 46%; Generation X 40%; Baby Boomers 34.4%; Silent Generation 24.5%); (2) patients with commercial insurance (39%) compared with Medicaid (32.7%) or Medicare (28.1%); (3) English speakers (33.7%) compared with those requiring an interpreter (24.5%); (4) patients who are Asian (35%) and non-Hispanic White (33.7%) compared with Black (30.1%) and Hispanic White (27.5%); (5) married/domestic partner patients (35%) compared with single/divorced/widowed (29.9%); (6) Charlson comorbidity index ≤ 3 (36.2%) compared with > 3 (31.3%); and (7) males (34.6%) compared with females (32.3%). Similar statistically significant SM utilization patterns were also seen. CONCLUSION: In the pandemic era, hematology/oncology telehealth and SM use rapidly increased in a manner that is feasible and sustained. Possible disparities existed in video visit and SM use by age, insurance plan, language, race, ethnicity, marital status, comorbidities, and sex.


Subject(s)
COVID-19 , Telemedicine , Aged , COVID-19/epidemiology , Female , Humans , Male , Medicare , Pandemics , Retrospective Studies , United States
4.
Perm J ; 26(2): 54-63, 2022 06 29.
Article in English | MEDLINE | ID: covidwho-1988459

ABSTRACT

Introduction The COVID-19 pandemic drove rapid, widespread adoption of telehealth (TH). We evaluated surgical telehealth utilization and outcomes for newly diagnosed breast cancer patients during the initial pandemic period. Methods We identified patients with breast cancer diagnosed March 17, 2020 through May 17, 2020 who underwent surgery as the initial treatment. Clinicodemographic characteristics were collected. Initial consultation types (office, telephone, or video) were categorized. Outcomes included time to consultation, surgeon touchpoints, time to surgery, surgery types, and reexcision rates. Continuous variables were compared using Mann-Whitney tests or t-tests, and categorical variables were compared using χ2 or Fisher's exact tests. Results Of 158 patients, 56% had initial telehealth consultations (21% telephone, 35% video) and 42% did not have a preoperative physical examination. Age, race/ethnicity, and stage distributions were similar between initial visit types. Median time to consultation was lower in the initial telehealth group than the office group (6 days vs 9 days, p = 0.01). Other outcomes (surgeon touchpoints, time to surgery, surgery type, reconstruction) were similar between visit types. We observed higher reexcision rates in patients with initial telehealth visits (20% telehealth vs 4% office, p = 0.01), but evaluation was limited by small numbers. The reexcision rate was 13% for patients with telehealth visits and no preoperative physical exam. Discussion During the initial pandemic period, the majority of new breast cancer patients had an initial telehealth surgical consultation. Office and telehealth consultation visits had comparable numbers of postconsultation surgeon touchpoints and most outcomes. Our findings suggest that telehealth consultations may be feasible for preoperative breast cancer consultations.


Subject(s)
Breast Neoplasms , COVID-19 , Telemedicine , Breast Neoplasms/diagnosis , Breast Neoplasms/surgery , Female , Humans , Pandemics , SARS-CoV-2 , Telemedicine/methods
5.
Oncol Nurs Forum ; 49(3): 223-231, 2022 05 01.
Article in English | MEDLINE | ID: covidwho-1808482

ABSTRACT

OBJECTIVES: To examine patient satisfaction and information recall after telehealth breast cancer survivorship visits with a nurse practitioner. SAMPLE & SETTING: Female survivors of breast cancer after their first visit with a nurse practitioner in the outpatient survivorship clinic post-treatment. METHODS & VARIABLES: Participants included female survivors who were originally diagnosed with stage 0-III breast cancer and have since completed an initial telehealth appointment to review the survivorship care plan. Survivors were invited to complete a 20-question electronic survey about their satisfaction and recall of visit information. RESULTS: 62 participants completed the survey and indicated an overall high level of satisfaction with telehealth survivorship appointments. Most recalled key survivorship information from the visit and felt the appropriate amount of information was discussed. Overall satisfaction was significantly correlated with the length and convenience of the appointment, and the personal manner and technical skills of the nurse practitioner. Survivors' age was not associated with significant differences in overall satisfaction. IMPLICATIONS FOR NURSING: Telehealth for initial survivorship visits demonstrated high satisfaction with telehealth and the overall visit as a low-cost intervention to treat symptoms.


Subject(s)
Breast Neoplasms , COVID-19 , Cancer Survivors , Telemedicine , Adenosine Monophosphate , Breast Neoplasms/therapy , Female , Humans , Pandemics , Personal Satisfaction , Survivors , Survivorship
6.
Breast Cancer Res Treat ; 191(3): 665-675, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1608179

ABSTRACT

PURPOSES: To delineate operational changes in Kaiser Permanente Northern California breast care and evaluate the impact of these changes during the initial COVID-19 Shelter-in-Place period (SiP, 3/17/20-5/17/20). METHODS: By extracting data from institutional databases and reviewing electronic medical charts, we compared clinical and treatment characteristics of breast cancer patients diagnosed 3/17/20-5/17/20 to those diagnosed 3/17/19-5/17/2019. Outcomes included time from biopsy to consultation and treatment. Comparisons were made using Chi-square or Wilcoxon rank-sum tests. RESULTS: Fewer new breast cancers were diagnosed in 2020 during the SiP period than during a similar period in 2019 (n = 247 vs n = 703). A higher percentage presented with symptomatic disease in 2020 than 2019 (78% vs 37%, p < 0.001). Higher percentages of 2020 patients presented with grade 3 (37% vs 25%, p = 0.004) and triple-negative tumors (16% vs 10%, p = 0.04). A smaller percentage underwent surgery first in 2020 (71% vs 83%, p < 0.001) and a larger percentage had neoadjuvant chemotherapy (16% vs 11%, p < 0.001). Telehealth utilization increased from 0.8% in 2019 to 70.0% in 2020. Times to surgery and neoadjuvant chemotherapy were shorter in 2020 than 2019 (19 vs 26 days, p < 0.001, and 23 vs 28 days, p = 0.03, respectively). CONCLUSIONS: During SiP, fewer breast cancers were diagnosed than during a similar period in 2019, and a higher proportion presented with symptomatic disease. Early-stage breast cancer diagnoses decreased, while metastatic cancer diagnoses remained similar. Telehealth increased significantly, and times to treatment were shorter in 2020 than 2019. Our system continued to provide timely breast cancer treatment despite significant pandemic-driven disruption.


Subject(s)
Breast Neoplasms , COVID-19 , Delivery of Health Care, Integrated , Breast Neoplasms/diagnosis , Breast Neoplasms/epidemiology , Breast Neoplasms/therapy , Female , Humans , Pandemics , SARS-CoV-2
7.
JAMA Netw Open ; 4(11): e2133877, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1530062

ABSTRACT

Importance: Telehealth use including secure messages has rapidly expanded since the COVID-19 pandemic, including for multidisciplinary aspects of cancer care. Recent reports described rapid uptake and various benefits for patients and clinicians, suggesting that telehealth may be in standard use after the pandemic. Objective: To examine attitudes and perceptions of multidisciplinary cancer care clinicians toward telehealth and secure messages. Design, Setting, and Participants: Cross-sectional specialty-specific survey (ie, some questions appear only for relevant specialties) among multidisciplinary cancer care clinicians, collected from April 29, 2020, to June 5, 2020. Participants were all 285 clinicians in the fields of medical oncology, radiation oncology, surgical oncology, survivorship, and oncology navigation from all 21 community cancer centers of Kaiser Permanente Northern California. Main Outcomes and Measures: Clinician satisfaction, perceived benefits and challenges of telehealth, perceived quality of telehealth and secure messaging, preferred visit and communication types for different clinical activities, and preferences regarding postpandemic telehealth use. Results: A total of 202 clinicians (71%) responded (104 of 128 medical oncologists, 34 of 37 radiation oncologists, 16 of 62 breast surgeons, 18 of 28 navigators, and 30 of 30 survivorship experts; 57% (116 of 202) were women; 73% [147 of 202] between ages 36-55 years). Seventy-six percent (n = 154) were satisfied with telehealth without statistically significant variations based on clinician characteristics. In-person visits were thought to promote a strong patient-clinician connection by 99% (n = 137) of respondents compared with 77% (n = 106) for video visits, 43% (n = 59) for telephone, and 14% (n = 19) for secure messages. The most commonly cited benefits of telehealth to clinicians included reduced commute (79%; n = 160), working from home (74%; n = 149), and staying on time (65%; n = 132); the most commonly cited negative factors included internet connection (84%; n = 170) or equipment problems (72%; n = 146), or physical examination needed (64%; n = 131). Most respondents (59%; n = 120) thought that video is adequate to manage the greater part of patient care in general; and most deemed various telehealth modalities suitable for any of the queried types of patient-clinician activities. For some specific activities, less than half of respondents thought that only an in-person visit is acceptable (eg, 49%; n = 66 for end-of-life discussion, 35%; n = 58 for new diagnosis). Most clinicians (82%; n = 166) preferred to maintain or increase use of telehealth after the pandemic. Conclusions and Relevance: In this survey of multidisciplinary cancer care clinicians in the COVID-19 era, telehealth was well received and often preferred by most cancer care clinicians, who deemed it appropriate to manage most aspects of cancer care. As telehealth use becomes routine in some cancer care settings, video and telephone visits and use of asynchronous secure messaging with patients in cancer care has clear potential to extend beyond the pandemic period.


Subject(s)
Attitude of Health Personnel , Medical Oncology/statistics & numerical data , Neoplasms/therapy , Patient Care Team/statistics & numerical data , Telemedicine/statistics & numerical data , Adult , COVID-19/epidemiology , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Surveys and Questionnaires , Videoconferencing/statistics & numerical data
8.
Open Forum Infect Dis ; 7(6): ofaa210, 2020 Jun.
Article in English | MEDLINE | ID: covidwho-1387982

ABSTRACT

BACKGROUND: Posterior oropharyngeal saliva is increasingly recognized as a valid respiratory specimen for SARS-CoV-2 diagnosis. It is easy to collect and suitable for community-wide screening. The optimal timing of collection is currently unknown, and we speculate that an early-morning specimen before oral hygiene and breakfast would increase the diagnostic yield. METHODS: Posterior oropharyngeal saliva was collected at 5 different time points within the same day from 18 patients with previously confirmed SARS-CoV-2 infection by molecular testing. Cycle threshold (Ct) values were compared. RESULTS: There was an overall trend of lower Ct values from specimens collected in the early morning, with a gradual decrease of viral load towards nighttime, but reaching statistical significance only when compared with the specimens collected at bedtime. Eight out of 13 subjects had a higher viral load in the early morning than the rest of the 4 time points (before lunch, before teatime at 3 pm, before dinner, before bedtime). CONCLUSIONS: The result suggests a diurnal variation of viral shedding from the upper respiratory tract with a trend showing higher viral load in the early morning. For community screening purposes, posterior oropharyngeal saliva could be taken throughout the day, but preferably in the early morning to maximize the yield.

9.
Cancer Med ; 10(18): 6327-6335, 2021 09.
Article in English | MEDLINE | ID: covidwho-1344970

ABSTRACT

BACKGROUND: We aimed to investigate the effects of COVID-19 on computed tomography (CT) imaging of cancer. METHODS: Cancer-related CTs performed at one academic hospital and three affiliated community hospitals in Massachusetts were retrospectively analyzed. Three periods of 2020 were considered as follows: pre-COVID-19 (1/5/20-3/14/20), COVID-19 peak (3/15/20-5/2/20), and post-COVID-19 peak (5/3/20-11/14/20). 15 March 2020 was the day a state of emergency was declared in MA; 3 May 2020 was the day our hospitals resumed to non-urgent imaging. The volumes were assessed by (1) Imaging indication: cancer screening, initial workup, active cancer, and surveillance; (2) Care setting: outpatient and inpatient, ED; (3) Hospital type: quaternary academic center (QAC), university-affiliated community hospital (UACH), and sole community hospitals (SCHs). RESULTS: During the COVID-19 peak, a significant drop in CT volumes was observed (-42.2%, p < 0.0001), with cancer screening, initial workup, active cancer, and cancer surveillance declining by 81.7%, 54.8%, 30.7%, and 44.7%, respectively (p < 0.0001). In the post-COVID-19 peak period, cancer screening and initial workup CTs did not recover (-11.7%, p = 0.037; -20.0%, p = 0.031), especially in the outpatient setting. CT volumes for active cancer recovered, but inconsistently across hospital types: the QAC experienced a 9.4% decline (p = 0.022) and the UACH a 41.5% increase (p < 0.001). Outpatient CTs recovered after the COVID-19 peak, but with a shift in utilization away from the QAC (-8.7%, p = 0.020) toward the UACH (+13.3%, p = 0.013). Inpatient and ED-based oncologic CTs increased post-peak (+20.0%, p = 0.004 and +33.2%, p = 0.009, respectively). CONCLUSIONS: Cancer imaging was severely impacted during the COVID-19 pandemic. CTs for cancer screening and initial workup did not recover to pre-COVID-19 levels well into 2020, a finding that suggests more patients with advanced cancers may present in the future. A redistribution of imaging utilization away from the QAC and outpatient settings, toward the community hospitals and inpatient setting/ED was observed.


Subject(s)
COVID-19/epidemiology , Neoplasms/diagnostic imaging , Pandemics/statistics & numerical data , Emergency Service, Hospital/statistics & numerical data , Hospitals , Humans , Inpatients/statistics & numerical data , Massachusetts/epidemiology , Outpatients/statistics & numerical data , Retrospective Studies , SARS-CoV-2/pathogenicity , Tomography, X-Ray Computed/methods
10.
Clin Infect Dis ; 73(1): 137-142, 2021 07 01.
Article in English | MEDLINE | ID: covidwho-1291923

ABSTRACT

After 2 months of relative quiescence, a large coronavirus disease 2019 outbreak occurred in Hong Kong in July 2020 after gradual relaxation of social distancing policy. Unique severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) phylogenetic clusters have been identified among locally acquired cases, with most genomes belonging to cluster HK1, which is phylogenetically related to SARS-CoV-2 reported overseas.


Subject(s)
COVID-19 , SARS-CoV-2 , Disease Outbreaks , Hong Kong , Humans , Phylogeny
11.
Emerg Infect Dis ; 27(1): 196-204, 2021 01.
Article in English | MEDLINE | ID: covidwho-993249

ABSTRACT

Initial cases of coronavirus disease in Hong Kong were imported from mainland China. A dramatic increase in case numbers was seen in February 2020. Most case-patients had no recent travel history, suggesting the presence of transmission chains in the local community. We collected demographic, clinical, and epidemiologic data from 50 patients, who accounted for 53.8% of total reported case-patients as of February 28, 2020. We performed whole-genome sequencing to determine phylogenetic relationship and transmission dynamics of severe acute respiratory syndrome coronavirus 2 infections. By using phylogenetic analysis, we attributed the community outbreak to 2 lineages; 1 harbored a common mutation, Orf3a-G251V, and accounted for 88.0% of the cases in our study. The estimated time to the most recent common ancestor of local coronavirus disease outbreak was December 24, 2019, with an evolutionary rate of 3.04 × 10-3 substitutions/site/year. The reproduction number was 1.84, indicating ongoing community spread.


Subject(s)
COVID-19/epidemiology , COVID-19/virology , Disease Outbreaks , Adult , Aged , Aged, 80 and over , COVID-19/transmission , Cluster Analysis , Disease Hotspot , Evolution, Molecular , Female , Hong Kong/epidemiology , Humans , Male , Middle Aged , Mutation , Phylogeny , Phylogeography , SARS-CoV-2/genetics , SARS-CoV-2/isolation & purification , Viroporin Proteins/genetics , Whole Genome Sequencing , Young Adult
15.
Psychooncology ; 2020 Sep 26.
Article in English | MEDLINE | ID: covidwho-796104

ABSTRACT

OBJECTIVE: Assess the feasibility of conducting a cluster randomized controlled trial (RCT) comparing technology-delivered mindfulness-based intervention (MBI) programs against a waitlist control arm targeting advanced cancer patients and their informal caregivers. METHODS: Two-arm cluster RCT within Kaiser Permanente Northern California. We recruited patients with metastatic solid malignancies or hematological cancers and their informal caregivers. Intervention-group participants chose to use either a commercially available mindfulness app (10-20 min/day) or a webinar-based mindfulness course for 6 weeks. The waitlist control group received usual care. We assessed feasibility measures and obtained participant-reported data on quality of life (QoL; primary outcome) and distress outcomes (secondary) pre- and postintervention. RESULTS: A hundred and three patients (median age 67 years; 70% female; 81% White) and 39 caregivers (median age 66 years; 79% female; 69% White) were enrolled. Nearly all participants chose the mindfulness app over the webinar-based program. Among the participants in the intervention arm who chose the mobile-app program and completed the postintervention (6-week) survey, 21 (68%) patients and 7 (47%) caregivers practiced mindfulness at least 50% of the days during the 6-week study period. Seventy-four percent of intervention participants were "very" or "extremely" satisfied with the mindfulness program. We observed improvements in anxiety, QoL, and mindfulness among patients in the intervention arm compared to those in the control group. CONCLUSIONS: We demonstrated the feasibility of conducting a cluster RCT of mHealth MBI for advanced cancer patients and their caregivers. Such remote interventions can be helpful particularly during the COVID-19 pandemic.

16.
Infection ; 49(2): 257-265, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-774008

ABSTRACT

PURPOSE: To evaluate the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in conjunctival secretions from patients without ocular symptoms. METHODS: Conjunctival swabs were prospectively collected from laboratory-confirmed Coronavirus disease 2019 (COVID-19) patients without ocular symptoms for reverse transcription-polymerase chain reaction (RT-PCR) and viral culture. RESULTS: A total of 158 conjunctival swabs were obtained from 49 laboratory-confirmed COVID-19 patients. The median duration of illness when the first conjunctival swab was obtained was 10 days (range 2-27 days). Four conjunctival swabs from four different patients (4/49, 8.2%) were positive for SARS-CoV-2 RNA by RT-PCR. The Ct values ranged from 32.7 to 37.7 (mean 35.4). Viral cultures were negative for all four RT-PCR-positive conjunctival swabs. CONCLUSION: Conjunctival secretions of a minority of COVID-19 patients without ocular symptoms may contain relatively low levels of SARS-CoV-2 RNA, but their infectiousness remains undetermined. Appropriate infection control measures should be implemented during ophthalmological assessment of COVID-19 patients to prevent potential nosocomial transmission of SARS-CoV-2.


Subject(s)
COVID-19/virology , Conjunctiva/virology , SARS-CoV-2/isolation & purification , Adult , Aged , Aged, 80 and over , Animals , COVID-19/diagnosis , COVID-19 Nucleic Acid Testing , Chlorocebus aethiops , Female , Humans , Male , Middle Aged , RNA, Viral/genetics , RNA, Viral/isolation & purification , SARS-CoV-2/genetics , SARS-CoV-2/growth & development , Vero Cells , Virus Shedding , Young Adult
17.
Int J Infect Dis ; 101: 74-82, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-758909

ABSTRACT

OBJECTIVES: To develop: (1) two validated risk prediction models for coronavirus disease-2019 (COVID-19) positivity using readily available parameters in a general hospital setting; (2) nomograms and probabilities to allow clinical utilisation. METHODS: Patients with and without COVID-19 were included from 4 Hong Kong hospitals. The database was randomly split into 2:1: for model development database (n = 895) and validation database (n = 435). Multivariable logistic regression was utilised for model creation and validated with the Hosmer-Lemeshow (H-L) test and calibration plot. Nomograms and probabilities set at 0.1, 0.2, 0.4 and 0.6 were calculated to determine sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). RESULTS: A total of 1330 patients (mean age 58.2 ± 24.5 years; 50.7% males; 296 COVID-19 positive) were recruited. The first prediction model developed had age, total white blood cell count, chest x-ray appearances and contact history as significant predictors (AUC = 0.911 [CI = 0.880-0.941]). The second model developed has the same variables except contact history (AUC = 0.880 [CI = 0.844-0.916]). Both were externally validated on the H-L test (p = 0.781 and 0.155, respectively) and calibration plot. Models were converted to nomograms. Lower probabilities give higher sensitivity and NPV; higher probabilities give higher specificity and PPV. CONCLUSION: Two simple-to-use validated nomograms were developed with excellent AUCs based on readily available parameters and can be considered for clinical utilisation.


Subject(s)
COVID-19/diagnosis , SARS-CoV-2 , Adult , Aged , Aged, 80 and over , Area Under Curve , COVID-19/etiology , Female , Hospitals , Humans , Logistic Models , Male , Middle Aged , Nomograms , Probability
18.
Lancet ; 395(10238): 1695-1704, 2020 05 30.
Article in English | MEDLINE | ID: covidwho-232479

ABSTRACT

BACKGROUND: Effective antiviral therapy is important for tackling the coronavirus disease 2019 (COVID-19) pandemic. We assessed the efficacy and safety of combined interferon beta-1b, lopinavir-ritonavir, and ribavirin for treating patients with COVID-19. METHODS: This was a multicentre, prospective, open-label, randomised, phase 2 trial in adults with COVID-19 who were admitted to six hospitals in Hong Kong. Patients were randomly assigned (2:1) to a 14-day combination of lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin 400 mg every 12 h, and three doses of 8 million international units of interferon beta-1b on alternate days (combination group) or to 14 days of lopinavir 400 mg and ritonavir 100 mg every 12 h (control group). The primary endpoint was the time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 RT-PCR, and was done in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT04276688. FINDINGS: Between Feb 10 and March 20, 2020, 127 patients were recruited; 86 were randomly assigned to the combination group and 41 were assigned to the control group. The median number of days from symptom onset to start of study treatment was 5 days (IQR 3-7). The combination group had a significantly shorter median time from start of study treatment to negative nasopharyngeal swab (7 days [IQR 5-11]) than the control group (12 days [8-15]; hazard ratio 4·37 [95% CI 1·86-10·24], p=0·0010). Adverse events included self-limited nausea and diarrhoea with no difference between the two groups. One patient in the control group discontinued lopinavir-ritonavir because of biochemical hepatitis. No patients died during the study. INTERPRETATION: Early triple antiviral therapy was safe and superior to lopinavir-ritonavir alone in alleviating symptoms and shortening the duration of viral shedding and hospital stay in patients with mild to moderate COVID-19. Future clinical study of a double antiviral therapy with interferon beta-1b as a backbone is warranted. FUNDING: The Shaw-Foundation, Richard and Carol Yu, May Tam Mak Mei Yin, and Sanming Project of Medicine.


Subject(s)
Coronavirus Infections/drug therapy , Interferon beta-1b/therapeutic use , Lopinavir/therapeutic use , Pneumonia, Viral/drug therapy , Ribavirin/therapeutic use , Ritonavir/therapeutic use , Adult , Betacoronavirus , COVID-19 , Drug Combinations , Drug Therapy, Combination , Female , Hong Kong , Hospitalization , Humans , Male , Middle Aged , Pandemics , SARS-CoV-2 , COVID-19 Drug Treatment
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