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1. The Postencounter Form System: Viewpoint on Efficient Data Collection Within Electronic Health Records

Author

Held, Philip, Boley, Randy A, Faig, Walter G, O'Toole, John A, Desai, Imran, Zalta, Alyson K, Khan, Jawad, Sims, Shannon, Brennan, Michael B, Van Horn, Rebecca, Glover, Angela C, Hota, Bala N, Patty, Brian D, Rab, S Shafiq, Pollack, Mark H, and Karnik, Niranjan S

Subjects
Medicine
Abstract

Electronic health records (EHRs) offer opportunities for research and improvements in patient care. However, challenges exist in using data from EHRs due to the volume of information existing within clinical notes, which can be labor intensive and costly to transform into usable data with existing strategies. This case report details the collaborative development and implementation of the postencounter form (PEF) system into the EHR at the Road Home Program at Rush University Medical Center in Chicago, IL to address these concerns with limited burden to clinical workflows. The PEF system proved to be an effective tool with over 98% of all clinical encounters including a completed PEF within 5 months of implementation. In addition, the system has generated over 325,188 unique, readily-accessible data points in under 4 years of use. The PEF system has since been deployed to other settings demonstrating that the system may have broader clinical utility.

Published
2020
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2. Three-Month Symptom Profiles Among Symptomatic Adults With Positive and Negative Severe Acute Respiratory Syndrome Coronavirus 2 Tests: A Prospective Cohort Study From the INSPIRE Group.

Author

Spatz, Erica, Gottlieb, Michael, Wisk, Lauren, Anderson, Jill, Chang, Anna, Gentile, Nicole, Hill, Mandy, Huebinger, Ryan, Idris, Ahamed, Kinsman, Jeremiah, Koo, Katherine, Li, Shu-Xia, McDonald, Samuel, Plumb, Ian, Rodriguez, Robert, Saydah, Sharon, Slovis, Benjamin, Stephens, Kari, Unger, Elizabeth, Wang, Ralph, Yu, Huihui, Hota, Bala, Elmore, Joann, Weinstein, Robert, and Venkatesh, Arjun

Subjects
COVID-19, SARS-CoV-2, long COVID, outcomes, registry, Adult, Female, Humans, Male, COVID-19, Post-Acute COVID-19 Syndrome, Prospective Studies, SARS-CoV-2, Text Messaging
Abstract

BACKGROUND: Long-term symptoms following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are a major concern, yet their prevalence is poorly understood. METHODS: We conducted a prospective cohort study comparing adults with SARS-CoV-2 infection (coronavirus disease-positive [COVID+]) with adults who tested negative (COVID-), enrolled within 28 days of a Food and Drug Administration (FDA)-approved SARS-CoV-2 test result for active symptoms. Sociodemographic characteristics, symptoms of SARS-CoV-2 infection (assessed with the Centers for Disease Control and Prevention [CDC] Person Under Investigation Symptom List), and symptoms of post-infectious syndromes (ie, fatigue, sleep quality, muscle/joint pains, unrefreshing sleep, and dizziness/fainting, assessed with CDC Short Symptom Screener for myalgic encephalomyelitis/chronic fatigue syndrome) were assessed at baseline and 3 months via electronic surveys sent via text or email. RESULTS: Among the first 1000 participants, 722 were COVID+ and 278 were COVID-. Mean age was 41.5 (SD 15.2); 66.3% were female, 13.4% were Black, and 15.3% were Hispanic. At baseline, SARS-CoV-2 symptoms were more common in the COVID+ group than the COVID- group. At 3 months, SARS-CoV-2 symptoms declined in both groups, although were more prevalent in the COVID+ group: upper respiratory symptoms/head/eyes/ears/nose/throat (HEENT; 37.3% vs 20.9%), constitutional (28.8% vs 19.4%), musculoskeletal (19.5% vs 14.7%), pulmonary (17.6% vs 12.2%), cardiovascular (10.0% vs 7.2%), and gastrointestinal (8.7% vs 8.3%); only 50.2% and 73.3% reported no symptoms at all. Symptoms of post-infectious syndromes were similarly prevalent among the COVID+ and COVID- groups at 3 months. CONCLUSIONS: Approximately half of COVID+ participants, as compared with one-quarter of COVID- participants, had at least 1 SARS-CoV-2 symptom at 3 months, highlighting the need for future work to distinguish long COVID. CLINICAL TRIALS REGISTRATION: NCT04610515.

Published
2023

3. Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection

Author

O’Laughlin, Kelli N, Thompson, Matthew, Hota, Bala, Gottlieb, Michael, Plumb, Ian D, Chang, Anna Marie, Wisk, Lauren E, Hall, Aron J, Wang, Ralph C, Spatz, Erica S, Stephens, Kari A, Huebinger, Ryan M, McDonald, Samuel A, Venkatesh, Arjun, Gentile, Nikki, Slovis, Benjamin H, Hill, Mandy, Saydah, Sharon, Idris, Ahamed H, Rodriguez, Robert, Krumholz, Harlan M, Elmore, Joann G, Weinstein, Robert A, and Nichol, Graham

Subjects
Patient Safety, HIV/AIDS, Clinical Trials and Supportive Activities, Prevention, Emerging Infectious Diseases, Vaccine Related, Biodefense, Infectious Diseases, Clinical Research, Lung, Pneumonia, Cancer, Infection, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, COVID-19, Case-Control Studies, Cohort Studies, Female, Humans, Longitudinal Studies, Male, Middle Aged, Palliative Care, Patient Reported Outcome Measures, Prognosis, Registries, SARS-CoV-2, Social Determinants of Health, Therapies, Investigational, Time Factors, Young Adult, INSPIRE Investigators, General Science & Technology
Abstract

BackgroundReports on medium and long-term sequelae of SARS-CoV-2 infections largely lack quantification of incidence and relative risk. We describe the rationale and methods of the Innovative Support for Patients with SARS-CoV-2 Registry (INSPIRE) that combines patient-reported outcomes with data from digital health records to understand predictors and impacts of SARS-CoV-2 infection.MethodsINSPIRE is a prospective, multicenter, longitudinal study of individuals with symptoms of SARS-CoV-2 infection in eight regions across the US. Adults are eligible for enrollment if they are fluent in English or Spanish, reported symptoms suggestive of acute SARS-CoV-2 infection, and if they are within 42 days of having a SARS-CoV-2 viral test (i.e., nucleic acid amplification test or antigen test), regardless of test results. Recruitment occurs in-person, by phone or email, and through online advertisement. A secure online platform is used to facilitate the collation of consent-related materials, digital health records, and responses to self-administered surveys. Participants are followed for up to 18 months, with patient-reported outcomes collected every three months via survey and linked to concurrent digital health data; follow-up includes no in-person involvement. Our planned enrollment is 4,800 participants, including 2,400 SARS-CoV-2 positive and 2,400 SARS-CoV-2 negative participants (as a concurrent comparison group). These data will allow assessment of longitudinal outcomes from SARS-CoV-2 infection and comparison of the relative risk of outcomes in individuals with and without infection. Patient-reported outcomes include self-reported health function and status, as well as clinical outcomes including health system encounters and new diagnoses.ResultsParticipating sites obtained institutional review board approval. Enrollment and follow-up are ongoing.ConclusionsThis study will characterize medium and long-term sequelae of SARS-CoV-2 infection among a diverse population, predictors of sequelae, and their relative risk compared to persons with similar symptomatology but without SARS-CoV-2 infection. These data may inform clinical interventions for individuals with sequelae of SARS-CoV-2 infection.

Published
2022

4. The Postencounter Form System: Viewpoint on Efficient Data Collection Within Electronic Health Records (Preprint)

Author

Held, Philip, Boley, Randy A, Faig, Walter G, O'Toole, John A, Desai, Imran, Zalta, Alyson K, Khan, Jawad, Sims, Shannon, Brennan, Michael B, Van Horn, Rebecca, Glover, Angela C, Hota, Bala N, Patty, Brian D, Rab, S Shafiq, Pollack, Mark H, and Karnik, Niranjan S

Abstract

UNSTRUCTURED Electronic health records (EHRs) offer opportunities for research and improvements in patient care. However, challenges exist in using data from EHRs due to the volume of information existing within clinical notes, which can be labor intensive and costly to transform into usable data with existing strategies. This case report details the collaborative development and implementation of the postencounter form (PEF) system into the EHR at the Road Home Program at Rush University Medical Center in Chicago, IL to address these concerns with limited burden to clinical workflows. The PEF system proved to be an effective tool with over 98% of all clinical encounters including a completed PEF within 5 months of implementation. In addition, the system has generated over 325,188 unique, readily-accessible data points in under 4 years of use. The PEF system has since been deployed to other settings demonstrating that the system may have broader clinical utility.

Published
2020

8. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome After SARS-CoV-2 Infection

Author

Unger, Elizabeth R., Lin, Jin-Mann S., Wisk, Lauren E., Yu, Huihui, L'Hommedieu, Michelle, Lavretsky, Helen, Montoy, Juan Carlos C., Gottlieb, Michael A., Rising, Kristin L., Gentile, Nicole L., Santangelo, Michelle, Venkatesh, Arjun K., Rodriguez, Robert M., Hill, Mandy J., Geyer, Rachel E., Kean, Efrat R., Saydah, Sharon, McDonald, Samuel A., Huebinger, Ryan, Idris, Ahamed H., Dorney, Jocelyn, Hota, Bala, Spatz, Erica S., Stephens, Kari A., Weinstein, Robert A., Elmore, Joann G., Unger, Elizabeth R., Lin, Jin-Mann S., Wisk, Lauren E., Yu, Huihui, L'Hommedieu, Michelle, Lavretsky, Helen, Montoy, Juan Carlos C., Gottlieb, Michael A., Rising, Kristin L., Gentile, Nicole L., Santangelo, Michelle, Venkatesh, Arjun K., Rodriguez, Robert M., Hill, Mandy J., Geyer, Rachel E., Kean, Efrat R., Saydah, Sharon, McDonald, Samuel A., Huebinger, Ryan, Idris, Ahamed H., Dorney, Jocelyn, Hota, Bala, Spatz, Erica S., Stephens, Kari A., Weinstein, Robert A., and Elmore, Joann G.

Abstract

IMPORTANCE: Chronic symptoms reported following an infection with SARS-CoV-2, such as cognitive problems, overlap with symptoms included in the definition of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). OBJECTIVE: To evaluate the prevalence of ME/CFS-like illness subsequent to acute SARS-CoV-2 infection, changes in ME/CFS symptoms through 12 months of follow-up, and the association of ME/CFS symptoms with SARS-CoV-2 test results at the acute infection-like index illness. DESIGN, SETTING, AND PARTICIPANTS: This prospective, multisite, longitudinal cohort study (Innovative Support for Patients with SARS-CoV-2 Infections Registry [INSPIRE]) enrolled participants from December 11, 2020, to August 29, 2022. Participants were adults aged 18 to 64 years with acute symptoms suggestive of SARS-CoV-2 infection who received a US Food and Drug Administration-approved SARS-CoV-2 test at the time of illness and did not die or withdraw from the study by 3 months. Follow-up surveys were collected through February 28, 2023. EXPOSURE: COVID-19 status (positive vs negative) at enrollment. MAIN OUTCOME AND MEASURES: The main outcome was the weighted proportion of participants with ME/CFS-like illness based on the 2015 Institute of Medicine clinical case definition using self-reported symptoms. RESULTS: A total of 4378 participants were included in the study. Most were female (3226 [68.1%]). Mean (SD) age was 37.8 (11.8) years. The survey completion rates ranged from 38.7% (3613 of 4738 participants) to 76.3% (1835 of 4738) and decreased over time. The weighted proportion of participants identified with ME/CFS-like illness did not change significantly at 3 through 12 months of follow-up and was similar in the COVID-19-positive (range, 2.8%-3.7%) and COVID-19-negative (range, 3.1%-4.5%) groups. Adjusted analyses revealed no significant difference in the odds of ME/CFS-like illness at any time point between COVID-19-positive and COVID-19-negative individuals (marginal odds

Published
2024

9. The Pandemic Response Commons.

Author

Trunnell, Matthew, Frankenberger, Casey, Hota, Bala, Hughes, Troy, Martinov, Plamen, Ravichandran, Urmila, Shah, Nirav S, Grossman, Robert L, and Consortium, Pandemic Response Commons

Published
2024
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10. Staphylococci

Author

Popovich, Kyle J., additional, Weinstein, Robert A., additional, and Hota, Bala, additional

Published
2020
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17. Three-Month Symptom Profiles Among Symptomatic Adults With Positive and Negative Severe Acute Respiratory Syndrome Coronavirus 2 Tests: A Prospective Cohort Study From the INSPIRE Group

Author

Spatz, Erica S, primary, Gottlieb, Michael, additional, Wisk, Lauren E, additional, Anderson, Jill, additional, Chang, Anna Marie, additional, Gentile, Nicole L, additional, Hill, Mandy J, additional, Huebinger, Ryan M, additional, Idris, Ahamed H, additional, Kinsman, Jeremiah, additional, Koo, Katherine, additional, Li, Shu-Xia, additional, McDonald, Samuel, additional, Plumb, Ian D, additional, Rodriguez, Robert M, additional, Saydah, Sharon, additional, Slovis, Benjamin, additional, Stephens, Kari A, additional, Unger, Elizabeth R, additional, Wang, Ralph C, additional, Yu, Huihui, additional, Hota, Bala, additional, Elmore, Joann G, additional, Weinstein, Robert A, additional, and Venkatesh, Arjun, additional

Published
2022
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40. Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection.

Author

O'Laughlin, Kelli N, Chi, Gerald1, O'Laughlin, Kelli N, Thompson, Matthew, Hota, Bala, Gottlieb, Michael, Plumb, Ian D, Chang, Anna Marie, Wisk, Lauren E, Hall, Aron J, Wang, Ralph C, Spatz, Erica S, Stephens, Kari A, Huebinger, Ryan M, McDonald, Samuel A, Venkatesh, Arjun, Gentile, Nikki, Slovis, Benjamin H, Hill, Mandy, Saydah, Sharon, Idris, Ahamed H, Rodriguez, Robert, Krumholz, Harlan M, Elmore, Joann G, Weinstein, Robert A, Nichol, Graham, INSPIRE Investigators, O'Laughlin, Kelli N, Chi, Gerald1, O'Laughlin, Kelli N, Thompson, Matthew, Hota, Bala, Gottlieb, Michael, Plumb, Ian D, Chang, Anna Marie, Wisk, Lauren E, Hall, Aron J, Wang, Ralph C, Spatz, Erica S, Stephens, Kari A, Huebinger, Ryan M, McDonald, Samuel A, Venkatesh, Arjun, Gentile, Nikki, Slovis, Benjamin H, Hill, Mandy, Saydah, Sharon, Idris, Ahamed H, Rodriguez, Robert, Krumholz, Harlan M, Elmore, Joann G, Weinstein, Robert A, Nichol, Graham, and INSPIRE Investigators

Abstract

BackgroundReports on medium and long-term sequelae of SARS-CoV-2 infections largely lack quantification of incidence and relative risk. We describe the rationale and methods of the Innovative Support for Patients with SARS-CoV-2 Registry (INSPIRE) that combines patient-reported outcomes with data from digital health records to understand predictors and impacts of SARS-CoV-2 infection.MethodsINSPIRE is a prospective, multicenter, longitudinal study of individuals with symptoms of SARS-CoV-2 infection in eight regions across the US. Adults are eligible for enrollment if they are fluent in English or Spanish, reported symptoms suggestive of acute SARS-CoV-2 infection, and if they are within 42 days of having a SARS-CoV-2 viral test (i.e., nucleic acid amplification test or antigen test), regardless of test results. Recruitment occurs in-person, by phone or email, and through online advertisement. A secure online platform is used to facilitate the collation of consent-related materials, digital health records, and responses to self-administered surveys. Participants are followed for up to 18 months, with patient-reported outcomes collected every three months via survey and linked to concurrent digital health data; follow-up includes no in-person involvement. Our planned enrollment is 4,800 participants, including 2,400 SARS-CoV-2 positive and 2,400 SARS-CoV-2 negative participants (as a concurrent comparison group). These data will allow assessment of longitudinal outcomes from SARS-CoV-2 infection and comparison of the relative risk of outcomes in individuals with and without infection. Patient-reported outcomes include self-reported health function and status, as well as clinical outcomes including health system encounters and new diagnoses.ResultsParticipating sites obtained institutional review board approval. Enrollment and follow-up are ongoing.ConclusionsThis study will characterize medium and long-term sequelae of SARS-CoV-2 infection among a diverse population

Published
2022

41. Association of Initial SARS-CoV-2 Test Positivity With Patient-Reported Well-being 3 Months After a Symptomatic Illness.

Author

Wisk, Lauren E, Gottlieb, Michael A, Spatz, Erica S, Yu, Huihui, Wang, Ralph C, Slovis, B. H., Saydah, Sharon, Plumb, Ian D, O'Laughlin, Kelli N, Montoy, Juan Carlos C, McDonald, Samuel A, Lin, Zhenqiu, Lin, Jin-Mann S, Koo, Katherine, Idris, Ahamed H, Huebinger, Ryan M, Hill, Mandy J, Gentile, Nicole L, Chang, Anna Marie, Anderson, Jill, Hota, Bala, Venkatesh, Arjun K, Weinstein, Robert A, Elmore, Joann G, Nichol, Graham, Wisk, Lauren E, Gottlieb, Michael A, Spatz, Erica S, Yu, Huihui, Wang, Ralph C, Slovis, B. H., Saydah, Sharon, Plumb, Ian D, O'Laughlin, Kelli N, Montoy, Juan Carlos C, McDonald, Samuel A, Lin, Zhenqiu, Lin, Jin-Mann S, Koo, Katherine, Idris, Ahamed H, Huebinger, Ryan M, Hill, Mandy J, Gentile, Nicole L, Chang, Anna Marie, Anderson, Jill, Hota, Bala, Venkatesh, Arjun K, Weinstein, Robert A, Elmore, Joann G, and Nichol, Graham

Abstract

IMPORTANCE: Long-term sequelae after symptomatic SARS-CoV-2 infection may impact well-being, yet existing data primarily focus on discrete symptoms and/or health care use. OBJECTIVE: To compare patient-reported outcomes of physical, mental, and social well-being among adults with symptomatic illness who received a positive vs negative test result for SARS-CoV-2 infection. DESIGN, SETTING, AND PARTICIPANTS: This cohort study was a planned interim analysis of an ongoing multicenter prospective longitudinal registry study (the Innovative Support for Patients With SARS-CoV-2 Infections Registry [INSPIRE]). Participants were enrolled from December 11, 2020, to September 10, 2021, and comprised adults (aged ≥18 years) with acute symptoms suggestive of SARS-CoV-2 infection at the time of receipt of a SARS-CoV-2 test approved by the US Food and Drug Administration. The analysis included the first 1000 participants who completed baseline and 3-month follow-up surveys consisting of questions from the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29; 7 subscales, including physical function, anxiety, depression, fatigue, social participation, sleep disturbance, and pain interference) and the PROMIS Short Form-Cognitive Function 8a scale, for which population-normed T scores were reported. EXPOSURES: SARS-CoV-2 status (positive or negative test result) at enrollment. MAIN OUTCOMES AND MEASURES: Mean PROMIS scores for participants with positive COVID-19 tests vs negative COVID-19 tests were compared descriptively and using multivariable regression analysis. RESULTS: Among 1000 participants, 722 (72.2%) received a positive COVID-19 result and 278 (27.8%) received a negative result; 406 of 998 participants (40.7%) were aged 18 to 34 years, 644 of 972 (66.3%) were female, 833 of 984 (84.7%) were non-Hispanic, and 685 of 974 (70.3%) were White. A total of 282 of 712 participants (39.6%) in the COVID-19-positive group and 147 of 275 participants (53.5%) in

Published
2022

48. Genomic Update of Phenotypic Prediction Rule for Methicillin-Resistant Staphylococcus aureus (MRSA) USA300 Discloses Jail Transmission Networks with Increased Resistance

Author

Sansom, Sarah E., primary, Benedict, Emily, additional, Thiede, Stephanie N., additional, Hota, Bala, additional, Aroutcheva, Alla, additional, Payne, Darjai, additional, Zawitz, Chad, additional, Snitkin, Evan S., additional, Green, Stefan J., additional, Weinstein, Robert A., additional, and Popovich, Kyle J., additional

Published
2021
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49. Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): a longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection

Author

O’Laughlin, Kelli N., primary, Thompson, Matthew, additional, Hota, Bala, additional, Gottlieb, Michael, additional, Plumb, Ian D., additional, Chang, Anna Marie, additional, Wisk, Lauren E., additional, Hall, Aron J., additional, Wang, Ralph C., additional, Spatz, Erica, additional, Stephens, Kari A., additional, Huebinger, Ryan M., additional, McDonald, Samuel A., additional, Venkatesh, Arjun, additional, Gentile, Nikki, additional, Slovis, Benjamin H., additional, Hill, Mandy, additional, Saydah, Sharon, additional, Idris, Ahamed H., additional, Rodriguez, Robert, additional, Krumholz, Harlan M., additional, Elmore, Joann G., additional, Weinstein, Robert A., additional, and Nichol, Graham, additional

Published
2021
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