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Multicenter Study
. 2022 Dec 1;5(12):e2244486.
doi: 10.1001/jamanetworkopen.2022.44486.

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

Lauren E Wisk  1   2 , Michael A Gottlieb  3 , Erica S Spatz  4   5 , Huihui Yu  4   5 , Ralph C Wang  6 , Benjamin H Slovis  7 , Sharon Saydah  8 , Ian D Plumb  8 , Kelli N O'Laughlin  9   10 , Juan Carlos C Montoy  6 , Samuel A McDonald  11   12 , Zhenqiu Lin  4   5 , Jin-Mann S Lin  13 , Katherine Koo  14 , Ahamed H Idris  11   15 , Ryan M Huebinger  16 , Mandy J Hill  16 , Nicole L Gentile  17   18 , Anna Marie Chang  7 , Jill Anderson  19 , Bala Hota  20 , Arjun K Venkatesh  5   21 , Robert A Weinstein  22   23 , Joann G Elmore  1   2 , Graham Nichol  9   19 ; INSPIRE Group
Collaborators, Affiliations
Multicenter Study

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

Lauren E Wisk et al. JAMA Netw Open. .

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 the COVID-19-negative group reported persistently poor physical, mental, or social well-being at 3-month follow-up. After adjustment, improvements in well-being were statistically and clinically greater for participants in the COVID-19-positive group vs the COVID-19-negative group only for social participation (β = 3.32; 95% CI, 1.84-4.80; P < .001); changes in other well-being domains were not clinically different between groups. Improvements in well-being in the COVID-19-positive group were concentrated among participants aged 18 to 34 years (eg, social participation: β = 3.90; 95% CI, 1.75-6.05; P < .001) and those who presented for COVID-19 testing in an ambulatory setting (eg, social participation: β = 4.16; 95% CI, 2.12-6.20; P < .001).

Conclusions and relevance: In this study, participants in both the COVID-19-positive and COVID-19-negative groups reported persistently poor physical, mental, or social well-being at 3-month follow-up. Although some individuals had clinically meaningful improvements over time, many reported moderate to severe impairments in well-being 3 months later. These results highlight the importance of including a control group of participants with negative COVID-19 results for comparison when examining the sequelae of COVID-19.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Gottlieb reported receiving funding from the Rush Center for Emerging Infectious Diseases Research Grant, the Society of Academic Emergency Medicine Foundation Research Grant, the Emergency Medicine Foundation/Council of Residency Directors in Emergency Medicine Education Research Grant, the Emergency Medicine: Reviews and Perspectives Medical Education Research Grant, and the University of Ottawa Department of Medicine Education Grant. Dr Spatz reported receiving personal fees from Regeneron Pharmaceuticals outside the submitted work. Dr Idris reported receiving grants from the University of Texas Southwestern Medical Center during the conduct of the study and being a member of the Stryker Belfast Clinical Advisory Board outside the submitted work. Dr Huebinger reported receiving grants from UTHealth Houston during the conduct of the study. Dr Gentile reported being the primary care and family medicine medical director of the Post-COVID Rehabilitation and Recovery Clinic at the University of Washington outside the submitted work. Dr Chang reported receiving grants from Abbott Laboratories and Siemens and being a current employee of CSL Behring outside the submitted work. Dr Venkatesh reported receiving grants from the Agency for Healthcare Research and Quality and the SAEM Foundation outside the submitted work. Dr Elmore reported serving as an editor in chief of adult primary care topics for UpToDate outside the submitted work. Dr Nichol reported receiving salary support from the Medic One Foundation; receiving research contracts from Abiomed, Vapotherm, and ZOLL Medical Corporation; serving as a consultant for Cellphire Therapeutics, CPR Therapeutics, Heartbeam, Invero Health, Orixha, and ZOLL Circulation; owning a patent for a method of measuring blood flow during cardiopulmonary resuscitation (licensed to the University of Washington); and having a patent pending for a combination drug device to modify reperfusion injury (licensed to the University of Washington) outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. INSPIRE Participant Flow Diagram
INSPIRE indicates Innovative Support for Patients With SARS-CoV-2 Infections Registry.
Figure 2.
Figure 2.. Scaled Scores on PROMIS Outcome Measures at Baseline and 3-Month Follow-up Among Participants With Positive vs Negative COVID-19 Test Results
Scaled scores were based on responses to the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS) survey (version 2.1) and the PROMIS Short Form–Cognitive Function 8a survey. Scores were not adjusted for demographic factors. For each domain, the mean (SD) score in the US was 50 (10) points. For cognitive function, physical, function, and social participation, higher scores are better; for all other measures, lower scores are better. Hashed lines between baseline and follow-up points indicate changes that did not meet the within-group clinically meaningful change of at least 2 points.
See this image and copyright information in PMC

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