Jianyu Lai | University of Maryland, College Park (original) (raw)

Papers by Jianyu Lai

Clinical Infectious Diseases

Background Aerosol inhalation is recognized as the dominant mode of severe acute respiratory synd... more Background Aerosol inhalation is recognized as the dominant mode of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission. Three highly transmissible lineages evolved during the pandemic. One hypothesis to explain increased transmissibility is that natural selection favors variants with higher rates of viral aerosol shedding. However, the extent of aerosol shedding of successive SARS-CoV-2 variants is unknown. We aimed to measure the infectivity and rate of SARS-CoV-2 shedding into exhaled breath aerosol (EBA) by individuals during the Delta and Omicron waves and compared those rates with those of prior SARS-CoV-2 variants from our previously published work. Methods Individuals with coronavirus disease 2019 (COVID-19) (n = 93; 32 vaccinated and 20 boosted) were recruited to give samples, including 30-minute breath samples into a Gesundheit-II EBA sampler. Samples were quantified for viral RNA using reverse-transcription polymerase chain reaction and cultured for ...

Aerosol inhalation is increasingly well recognized as a major if not primary mode of transmission... more Aerosol inhalation is increasingly well recognized as a major if not primary mode of transmission of SARS-CoV-2. Over the course of the COVID-19 pandemic, three highly transmissible lineages evolved and became globally dominant. One hypothesis to explain increased transmissibility is that natural selection favours variants with higher rates of viral aerosol shedding. However, the extent of aerosol shedding of successive SARS-CoV-2 variants is unknown. Here, we demonstrate that viral shedding (measured as RNA copies) into exhaled breath aerosol was significantly greater during infections with Alpha, Delta, and Omicron than with ancestral strains and variants not associated with increased transmissibility. The three highly transmissible variants independently evolved a high viral aerosol shedding phenotype, demonstrating convergent evolution. We did not observe statistically significant differences in rates of shedding between Alpha, Delta, and Omicron infections. The highest shedder ...

Microbiology Spectrum

The findings of this manuscript are increasingly important with new variants that appear to have ... more The findings of this manuscript are increasingly important with new variants that appear to have shorter incubation periods emerging, which may be more prone to detection in saliva before detection in nasal swabs. Therefore, there is an urgent need to provide the science to support the use of a detection method that is highly sensitive and widely acceptable to the public to improve screening rates and early detection.

From December 16 through 21 of 2021, we collected exhaled breath aerosol (EBA) from five members ... more From December 16 through 21 of 2021, we collected exhaled breath aerosol (EBA) from five members of a University campus community infected with SARS-CoV-2 viruses displaying an S-gene target failure when assayed using the TaqPath COVID-19 Real Time PCR Assay (Thermo Scientific).

BackgroundSaliva is an attractive sample for detecting SARS-CoV-2. However, contradictory reports... more BackgroundSaliva is an attractive sample for detecting SARS-CoV-2. However, contradictory reports exist concerning the sensitivity of saliva versus nasal swabs.MethodsWe followed close contacts of COVID-19 cases for up to 14 days from last exposure and collected self-reported symptoms, mid-turbinate swabs (MTS), and saliva every two or three days. Ct values, viral load, and frequency of viral detection by MTS and saliva were compared.Results58 contacts provided 200 saliva-MTS pairs; 14 contacts (13 with symptoms) had one or more positive samples. Saliva and MTS had similar rates of viral detection (p=0.78) and substantial agreement (κ=0.83). However, sensitivity varied significantly with time since symptom onset. Early on (days -3 to 2), saliva had 12 times (95%CI: 1.2, 130) greater likelihood of viral detection and 3.2 times (95% CI: 2.8, 3.8) higher RNA copy numbers compared to MTS. After day 2 post-symptoms, there was a non-significant trend toward greater sensitivity using MTS.C...

Pilot and Feasibility Studies, 2019

Background: Femoral neck fractures in patients ≤ 60 years of age are often very different injurie... more Background: Femoral neck fractures in patients ≤ 60 years of age are often very different injuries compared to low-energy, hip fractures in elderly patients and are difficult to manage because of inherent problems associated with high-energy trauma mechanisms and increased functional demands for recovery. Internal fixation, with multiple cancellous screws or a sliding hip screw (SHS), is the most common treatment for this injury in young patients. However, there is no clinical consensus regarding which surgical technique is optimal. Additionally, there is compelling rationale to use vitamin D supplementation to nutritionally optimize bone healing in young patients. This pilot trial will determine feasibility and provide preliminary clinical data for a larger definitive trial. Methods: We will conduct a multicenter, concealed randomized controlled pilot study, using a 2 × 2 factorial design in 60 patients aged 18-60 years with a femoral neck fracture. Eligible patients will be randomized in equal proportions to one of four groups: 1) SHS and vitamin D supplementation (4000 international units (IU) daily dose) for 6 months, 2) cancellous screws and vitamin D supplementation (4000 IU daily dose) for 6 months, 3) SHS and placebo, and 4) cancellous screws and placebo. Participants will be followed for 12 months post-fracture. Feasibility outcomes include initiation of clinical sites, recruitment, follow-up, data quality, and protocol adherence. Clinical outcomes, for both the pilot and planned definitive trials, include a composite of patient-important outcomes (re-operation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion), health-related quality of life and patient-reported function, fracture healing complications, and radiographic fracture healing. A priori success criteria have been established. If the pilot study is deemed successful, study participants will be included in the definitive trial and clinical outcomes for the pilot will not be analyzed. If the pilot study is not deemed successful, clinical outcome data will be analyzed. Discussion: Results of this study will inform the feasibility of a definitive trial. If clinical outcome data are analyzed, they will be disseminated through a publication and presentations.

Quality of Life Research, 2021

To develop a set of consensus and empirically based reporting recommendations for primary studies... more To develop a set of consensus and empirically based reporting recommendations for primary studies of the measurement properties of patient-reported outcome measures (PROMs). This study included four phases: 1. Conducting an extensive literature review of recommendations for reporting of studies testing measurement properties of PROMs; 2. Preparing for the Delphi study by identifying experts; 3. Conducting three Delphi rounds aiming for consensus on the item list of recommendations found in phase 1; 4. Developing the COSMIN reporting guideline and user manual. The literature review resulted in 93 reporting items, included in the first Delphi round. A total of 84 individuals (from 12 countries) agreed to participate in the Delphi study, with 47, 30 and 25 responding in rounds one, two and three, respectively. After three rounds, we achieved consensus on a set of 71 items separated into a set of 35 "common" items (relevant to all studies on measurement properties) and 41 "specific" items (exclusively relevant to one of the nine measurement properties). Consensus was achieved on a set of 71 items for inclusion in a reporting guideline for studies on measurement properties of PROMs. These items will guide researchers on the necessary information to include in their reports of investigations of measurement properties of PROMs. This guideline will likely improve the completeness of reporting of these important studies.

Clinical Infectious Diseases

Background Aerosol inhalation is recognized as the dominant mode of severe acute respiratory synd... more Background Aerosol inhalation is recognized as the dominant mode of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission. Three highly transmissible lineages evolved during the pandemic. One hypothesis to explain increased transmissibility is that natural selection favors variants with higher rates of viral aerosol shedding. However, the extent of aerosol shedding of successive SARS-CoV-2 variants is unknown. We aimed to measure the infectivity and rate of SARS-CoV-2 shedding into exhaled breath aerosol (EBA) by individuals during the Delta and Omicron waves and compared those rates with those of prior SARS-CoV-2 variants from our previously published work. Methods Individuals with coronavirus disease 2019 (COVID-19) (n = 93; 32 vaccinated and 20 boosted) were recruited to give samples, including 30-minute breath samples into a Gesundheit-II EBA sampler. Samples were quantified for viral RNA using reverse-transcription polymerase chain reaction and cultured for ...

Aerosol inhalation is increasingly well recognized as a major if not primary mode of transmission... more Aerosol inhalation is increasingly well recognized as a major if not primary mode of transmission of SARS-CoV-2. Over the course of the COVID-19 pandemic, three highly transmissible lineages evolved and became globally dominant. One hypothesis to explain increased transmissibility is that natural selection favours variants with higher rates of viral aerosol shedding. However, the extent of aerosol shedding of successive SARS-CoV-2 variants is unknown. Here, we demonstrate that viral shedding (measured as RNA copies) into exhaled breath aerosol was significantly greater during infections with Alpha, Delta, and Omicron than with ancestral strains and variants not associated with increased transmissibility. The three highly transmissible variants independently evolved a high viral aerosol shedding phenotype, demonstrating convergent evolution. We did not observe statistically significant differences in rates of shedding between Alpha, Delta, and Omicron infections. The highest shedder ...

Microbiology Spectrum

The findings of this manuscript are increasingly important with new variants that appear to have ... more The findings of this manuscript are increasingly important with new variants that appear to have shorter incubation periods emerging, which may be more prone to detection in saliva before detection in nasal swabs. Therefore, there is an urgent need to provide the science to support the use of a detection method that is highly sensitive and widely acceptable to the public to improve screening rates and early detection.

From December 16 through 21 of 2021, we collected exhaled breath aerosol (EBA) from five members ... more From December 16 through 21 of 2021, we collected exhaled breath aerosol (EBA) from five members of a University campus community infected with SARS-CoV-2 viruses displaying an S-gene target failure when assayed using the TaqPath COVID-19 Real Time PCR Assay (Thermo Scientific).

BackgroundSaliva is an attractive sample for detecting SARS-CoV-2. However, contradictory reports... more BackgroundSaliva is an attractive sample for detecting SARS-CoV-2. However, contradictory reports exist concerning the sensitivity of saliva versus nasal swabs.MethodsWe followed close contacts of COVID-19 cases for up to 14 days from last exposure and collected self-reported symptoms, mid-turbinate swabs (MTS), and saliva every two or three days. Ct values, viral load, and frequency of viral detection by MTS and saliva were compared.Results58 contacts provided 200 saliva-MTS pairs; 14 contacts (13 with symptoms) had one or more positive samples. Saliva and MTS had similar rates of viral detection (p=0.78) and substantial agreement (κ=0.83). However, sensitivity varied significantly with time since symptom onset. Early on (days -3 to 2), saliva had 12 times (95%CI: 1.2, 130) greater likelihood of viral detection and 3.2 times (95% CI: 2.8, 3.8) higher RNA copy numbers compared to MTS. After day 2 post-symptoms, there was a non-significant trend toward greater sensitivity using MTS.C...

Pilot and Feasibility Studies, 2019

Background: Femoral neck fractures in patients ≤ 60 years of age are often very different injurie... more Background: Femoral neck fractures in patients ≤ 60 years of age are often very different injuries compared to low-energy, hip fractures in elderly patients and are difficult to manage because of inherent problems associated with high-energy trauma mechanisms and increased functional demands for recovery. Internal fixation, with multiple cancellous screws or a sliding hip screw (SHS), is the most common treatment for this injury in young patients. However, there is no clinical consensus regarding which surgical technique is optimal. Additionally, there is compelling rationale to use vitamin D supplementation to nutritionally optimize bone healing in young patients. This pilot trial will determine feasibility and provide preliminary clinical data for a larger definitive trial. Methods: We will conduct a multicenter, concealed randomized controlled pilot study, using a 2 × 2 factorial design in 60 patients aged 18-60 years with a femoral neck fracture. Eligible patients will be randomized in equal proportions to one of four groups: 1) SHS and vitamin D supplementation (4000 international units (IU) daily dose) for 6 months, 2) cancellous screws and vitamin D supplementation (4000 IU daily dose) for 6 months, 3) SHS and placebo, and 4) cancellous screws and placebo. Participants will be followed for 12 months post-fracture. Feasibility outcomes include initiation of clinical sites, recruitment, follow-up, data quality, and protocol adherence. Clinical outcomes, for both the pilot and planned definitive trials, include a composite of patient-important outcomes (re-operation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion), health-related quality of life and patient-reported function, fracture healing complications, and radiographic fracture healing. A priori success criteria have been established. If the pilot study is deemed successful, study participants will be included in the definitive trial and clinical outcomes for the pilot will not be analyzed. If the pilot study is not deemed successful, clinical outcome data will be analyzed. Discussion: Results of this study will inform the feasibility of a definitive trial. If clinical outcome data are analyzed, they will be disseminated through a publication and presentations.

Quality of Life Research, 2021

To develop a set of consensus and empirically based reporting recommendations for primary studies... more To develop a set of consensus and empirically based reporting recommendations for primary studies of the measurement properties of patient-reported outcome measures (PROMs). This study included four phases: 1. Conducting an extensive literature review of recommendations for reporting of studies testing measurement properties of PROMs; 2. Preparing for the Delphi study by identifying experts; 3. Conducting three Delphi rounds aiming for consensus on the item list of recommendations found in phase 1; 4. Developing the COSMIN reporting guideline and user manual. The literature review resulted in 93 reporting items, included in the first Delphi round. A total of 84 individuals (from 12 countries) agreed to participate in the Delphi study, with 47, 30 and 25 responding in rounds one, two and three, respectively. After three rounds, we achieved consensus on a set of 71 items separated into a set of 35 "common" items (relevant to all studies on measurement properties) and 41 "specific" items (exclusively relevant to one of the nine measurement properties). Consensus was achieved on a set of 71 items for inclusion in a reporting guideline for studies on measurement properties of PROMs. These items will guide researchers on the necessary information to include in their reports of investigations of measurement properties of PROMs. This guideline will likely improve the completeness of reporting of these important studies.