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Tag: long covid outcomes

A National Evaluation of Outcomes in Long COVID Services using Digital PROM Data from the ELAROS Platform

Summary:

Key findings of this service evaluation study:
• Patient characteristics: A sample of 5,318 patients from 14 participating NHS LC sites were analysed. The sample had a female:male ratio of 2.1:1. The average age was 48.4 yrs, with 87% (of those whose ethnicity was recorded) of white ethnicity and 9% of Black or Asian ethnicity.
• Comorbidities: This sample of patients had a low prevalence of co-morbidities (7%) with a clear onset of new LC symptoms after their COVID-19 infection supporting the onset of a new condition in this cohort of previously healthy individuals.
• Duration of LC: The average duration of LC in this sample was 384 days (>12 months) at first assessment in an LC site, with symptoms still ongoing at presentation, with more than 90% of the sample being non-hospitalised patients.
• Digital platform: A total of 17,471 PROMs (C19-YRS and EQ-5D-5L) were completed by this sample of patients with at least 1,532 participants completing multiple assessments on the same PROM on the digital PROM platform. The completion of PROMs around the 3-month mark was low for both measures (11.7% for C19-YRS and 14.6% for EQ-5D-5L). The ones who completed PROMs both around the 3-month mark and the 6-month mark were 4.3% for C19-YRS and 5% for EQ-5D-5L. This limits the generalisability of the findings in this evaluation to all the LC population, but the findings remain valid for this cohort of individuals.
• New-onset disability: 3,395 patients who completed at least one C19-YRS questionnaire at first assessment showed significant new-onset symptom burden, functional disability, and deterioration of overall health since the COVID-19 infection.
• Comparison between LC and other chronic conditions: The cross-sectional EQ-5D-5L Index value of 3,438 patients suggests the burden and disability in LC are worse than that reported in the literature for Diabetes Mellitus, COPD, Heart Failure, and Multiple Sclerosis.
• 3-month follow-up: Among those who completed an initial C19-YRS assessment and another at 3 months, there was a statistically significant improvement in symptom burden, functional disability and overall health. Patients at 3 months however still had significant LC symptom
burden and disability compared to their pre-COVID-19 health status, i.e., their condition had improved, but they were far off from a complete recovery. Among those who completed EQ-5D- National Evaluation of Long COVID Service Outcomes using ELAROS Data (09 Oct 23) Page 3 of 31
5L, at first assessment and at 3 months, their EQ-5D-5L Index score did not show any statistically significant improvement, but the EQ-5D-5L VAS showed a statistically significant improvement.
• 6-month follow-up: Among those who completed measures at the first assessment, 3 months, and 6 months, C19-YRS and EQ-5D-5L VAS showed statistically significant improvement whereas EQ-5D-5L Index Value showed statistically significant deterioration. Patients at 6 months still had
significant LC symptom burden and disability compared to their pre-COVID-19 health status, i.e., their condition had improved but had not fully recovered. The follow-up changes in scores support the efficacy of interventions provided by LC services and suggest that continued specialist input is needed to manage these patients with persistent symptoms.
• C19-YRS (condition-specific measure) vs EQ-5D-5L (generic measure): The 3-month month follow-up changes in scores and responsiveness of PROMs highlight that C19-YRS is a more sensitive measure than EQ-5D-5L in this cohort of individuals with LC. This is in keeping with the literature recommending the use of condition-specific measures in addition to EQ-5D-5L.
• Vocational problems: 62% of this sample had their work role affected with them having to either be on sick leave, reduce hours, change roles, or quit roles. Only 21% were able to maintain their previous roles held prior to their COVID-19 infection. This is suggestive of considerable productivity loss and financial implications to the country.
• Fluctuating condition: In patients who completed multiple assessments, it was evident that LC is a fluctuant condition with no necessary linear trend of improvement or deterioration between the domains of symptom burden, functional disability, and overall health. This highlights the need to understand the triggers for the condition and invest in self-management and ongoing support from community healthcare services.
• Long-Term Condition: In most patients in this sample, LC has evidently become a Long-Term Condition (LTC) with fluctuations in their condition causing disability and significant deterioration of their overall health status seen even after 18 months of LC with no complete resolution or full recovery. There needs to be a national investment in managing this new LTC along with other LTCs.

Source: Dr Manoj Sivan, et al.  A National Evaluation of Outcomes in Long COVID Services using Digital PROM Data from the ELAROS Platform. National Evaluation of Long COVID Service Outcomes using ELAROS Data (09 Oct 23) https://locomotion.leeds.ac.uk/wp-content/uploads/sites/74/2023/10/National-Evaluation-of-LC-Service-Outcomes-using-ELAROS-Data-09-10-23.pdf (Full text)

The health impact of long COVID: a cross-sectional examination of health-related quality of life, disability, and health status among individuals with self-reported post-acute sequelae of SARS CoV-2 infection at various points of recovery

Abstract:

Objective: The novel Coronavirus (COVID-19) has continued to present a significant burden to global public health efforts. The purpose of this study was to estimate the health-related quality of life, disability, and health status of individuals with self-reported long COVID at various lengths of recovery.

Methods: We conducted a cross-sectional online survey of individuals with self-reported long COVID. Participants were asked to complete the five-item EuroQOL EQ-5D-5L and EQ visual analog scale, the 12-item World Health Organization Disability Assessment Schedule (WHODAS) 2.0 and the 10-item Patient Reported Outcome Measurement Information System (PROMIS) Global Health v1.2 short form. Descriptive and inferential statistics were used to characterize the responses and differences across groups.

Results: Eighty-two participants from 13 countries completed the EQ-5D-5L, 73 completed the WHODAS 2.0 and 80 participants completed the PROMIS. The mean EQ-5D-5L utility score was 0.51. The mean WHODAS score was 49.0. In the previous 30 days, participants reported their symptoms affected them for a mean of 24 days, they were totally unable to carry out usual activities for 15 days, and they cut back or reduced activities for 26 days. The mean PROMIS physical health and mental health scores were 10.7 and 8.6, respectively, corresponding to below-average health. No significant differences were detected across time or according to severity of acute infection.

Conclusions: Long COVID presents a significant chronic health burden to adults in the US and abroad. This health burden may persist for many months post-acute infection.

Source: Tak CR. The health impact of long COVID: a cross-sectional examination of health-related quality of life, disability, and health status among individuals with self-reported post-acute sequelae of SARS CoV-2 infection at various points of recovery. J Patient Rep Outcomes. 2023 Mar 21;7(1):31. doi: 10.1186/s41687-023-00572-0. PMID: 36943643; PMCID: PMC10029785. https://jpro.springeropen.com/articles/10.1186/s41687-023-00572-0 (Full text)

Computable Clinical Phenotyping of Postacute Sequelae of COVID-19 in Pediatrics Using Real-World Data

INTRODUCTION:

Since the SARS-CoV-2 pandemic began in late 2019, over 13 million children in the United States have been infected with the virus [1]. Although many of these acute infections have not resulted in severe morbidity or mortality, a subset of children and adolescents have experienced recurrent or persistent symptoms beyond the typical recovery period [2]. The constellation of findings that occur postinfection is known as postacute sequelae of SARS-CoV-2 (PASC), or colloquially as “long-Covid.” The U.S. Centers for Disease Control and Prevention (CDC) defines PASC as a wide range of health problems that linger for more than 4 weeks following an acute COVID-19 infection [3]. Although this is an area of active research, relatively little is currently known about its clinical epidemiology in the pediatric population.

Considering the large number of children who have been affected by COVID-19, it is critical that we monitor the rates, trends, and outcomes of PASC in this population. An important first step toward these efforts is the development of a tool that can quickly and easily identify cases in large clinical populations. With the widespread adoption of electronic health records (EHR), it is now possible to develop computable phenotypes using data that are collected for clinical care, which can be used for population-level analysis to inform the public health response [4, 5]. In this report, we describe a novel phenotyping algorithm to define the burden, clinical spectrum, and outcomes of pediatric PASC using real-world data.

Source: Tomini A Fashina, Christine M Miller, Elijah Paintsil, Linda M Niccolai, Cynthia Brandt, Carlos R Oliveira, Computable Clinical Phenotyping of Postacute Sequelae of COVID-19 in Pediatrics Using Real-World Data, Journal of the Pediatric Infectious Diseases Society, 2022;, piac132, https://doi.org/10.1093/jpids/piac132 https://academic.oup.com/jpids/advance-article/doi/10.1093/jpids/piac132/6957369 (Full text)

Nirmatrelvir and the Risk of Post-Acute Sequelae of COVID-19

Abstract:

Long Covid — the disease encompassing the post-acute sequelae of SARS-CoV-2 (PASC) — affects millions of people around the world. Prevention of PASC is an urgent public health priority. In this work, we aimed to examine whether treatment with nirmatrelvir in the acute phase of COVID-19 is associated with reduced risk of post-acute sequelae.

We used the healthcare databases of the US Department of Veterans Affairs to identify users of the health system who had a SARS-CoV-2 positive test between March 01, 2022 and June 30, 2022, were not hospitalized on the day of the positive test, had at least 1 risk factor for progression to severe COVID-19 illness and survived the first 30 days after SARS-CoV-2 diagnosis. We identify those who were treated with oral nirmatrelvir within 5 days after the positive test (n=9217) and those who received no COVID-19 antiviral or antibody treatment during the acute phase of SARS-CoV-2 infection (control group, n= 47,123). Inverse probability weighted survival models were used to estimate the effect of nirmatrelvir (versus control) on a prespecified panel of 12 post-acute COVID-19 outcomes and reported as hazard ratio (HR) and absolute risk reduction (ARR) in percentage at 90 days.

Compared to the control group, treatment with nirmatrelvir was associated with reduced risk of PASC (HR 0.74 95% CI (0.69, 0.81), ARR 2.32 (1.73, 2.91)) including reduced risk of 10 of 12 post-acute sequelae in the cardiovascular system (dysrhythmia and ischemic heart disease), coagulation and hematologic disorders (deep vein thrombosis, and pulmonary embolism), fatigue, liver disease, acute kidney disease, muscle pain, neurocognitive impairment, and shortness of breath. Nirmatrelvir was also associated with reduced risk of post-acute death (HR 0.52 (0.35, 0.77), ARR 0.28 (0.14, 0.41)), and post-acute hospitalization (HR 0.70 (0.61, 0.80), ARR 1.09 (0.72, 1.46)). Nirmatrelvir was associated with reduced risk of PASC in people who were unvaccinated, vaccinated, and boosted, and in people with primary SARS-CoV-2 infection and reinfection.

In sum, our results show that in people with SARS-CoV-2 infection who had at least 1 risk factor for progression to severe COVID-19 illness, treatment with nirmatrelvir within 5 days of a positive SARS-CoV-2 test was associated with reduced risk of PASC regardless of vaccination status and history of prior infection. The totality of findings suggests that treatment with nirmatrelvir during the acute phase of COVID-19 reduces the risk of post-acute adverse health outcomes.

Source: Yan Xie, Taeyoung Choi, Ziyad Al-Aly. Nirmatrelvir and the Risk of Post-Acute Sequelae of COVID-19. medRxiv 2022.11.03.22281783; doi: https://doi.org/10.1101/2022.11.03.22281783 https://www.medrxiv.org/content/10.1101/2022.11.03.22281783v1.full.pdf (Full text)

Long COVID: long-term health outcomes and implications for policy and research

Long COVID, which refers to post-acute and chronic sequelae of SARS-CoV-2 infection, can affect nearly every organ system and all demographic groups. The high and growing toll of long COVID calls for an urgent need to understand how to prevent and treat it. Governments and health systems must address the care needs of people with long COVID.

Shortly after the beginning of the COVID-19 global pandemic, reports emerged showing that some individuals infected with SARS-CoV-2 developed persistent symptoms and new health problems that arose long after the acute phase of infection and could not be explained by other factors1. The patient community who, to their credit, first recognized and reported this new syndrome used the term ‘long COVID’ to describe the post-acute and chronic sequelae of SARS-CoV-2 infection1. Long COVID can affect people across the lifespan — children, young adults and older adults — and across sex, race and ethnicity, and baseline health status2. Importantly, this syndrome not only affects patients who had severe COVID-19, but is also observed in individuals who were asymptomatic or mildly symptomatic during the acute phase of SARS-CoV-2 infection.

Read the rest of this article HERE. 

Source: Al-Aly, Z., Agarwal, A., Alwan, N. et al. Long COVID: long-term health outcomes and implications for policy and research. Nat Rev Nephrol (2022). https://doi.org/10.1038/s41581-022-00652-2  (Full text)

Neurological and psychiatric risk trajectories after SARS-CoV-2 infection: an analysis of 2-year retrospective cohort studies including 1 284 437 patients

Summary:

Background: COVID-19 is associated with increased risks of neurological and psychiatric sequelae in the weeks and months thereafter. How long these risks remain, whether they affect children and adults similarly, and whether SARS-CoV-2 variants differ in their risk profiles remains unclear.

Methods: In this analysis of 2-year retrospective cohort studies, we extracted data from the TriNetX electronic health records network, an international network of de-identified data from health-care records of approximately 89 million patients collected from hospital, primary care, and specialist providers (mostly from the USA, but also from Australia, the UK, Spain, Bulgaria, India, Malaysia, and Taiwan). A cohort of patients of any age with COVID-19 diagnosed between Jan 20, 2020, and April 13, 2022, was identified and propensity-score matched (1:1) to a contemporaneous cohort of patients with any other respiratory infection. Matching was done on the basis of demographic factors, risk factors for COVID-19 and severe COVID-19 illness, and vaccination status. Analyses were stratified by age group (age <18 years [children], 18–64 years [adults], and ≥65 years [older adults]) and date of diagnosis. We assessed the risks of 14 neurological and psychiatric diagnoses after SARS-CoV-2 infection and compared these risks with the matched comparator cohort. The 2-year risk trajectories were represented by time-varying hazard ratios (HRs) and summarised using the 6-month constant HRs (representing the risks in the earlier phase of follow-up, which have not yet been well characterised in children), the risk horizon for each outcome (ie, the time at which the HR returns to 1), and the time to equal incidence in the two cohorts. We also estimated how many people died after a neurological or psychiatric diagnosis during follow-up in each age group. Finally, we compared matched cohorts of patients diagnosed with COVID-19 directly before and after the emergence of the alpha (B.1.1.7), delta (B.1.617.2), and omicron (B.1.1.529) variants.

Findings: We identified 1 487 712 patients with a recorded diagnosis of COVID-19 during the study period, of whom 1 284 437 (185 748 children, 856 588 adults, and 242 101 older adults; overall mean age 42·5 years [SD 21·9]; 741 806 [57·8%] were female and 542 192 [42·2%] were male) were adequately matched with an equal number of patients with another respiratory infection. The risk trajectories of outcomes after SARS-CoV-2 infection in the whole cohort differed substantially. While most outcomes had HRs significantly greater than 1 after 6 months (with the exception of encephalitis; Guillain-Barré syndrome; nerve, nerve root, and plexus disorder; and parkinsonism), their risk horizons and time to equal incidence varied greatly. Risks of the common psychiatric disorders returned to baseline after 1–2 months (mood disorders at 43 days, anxiety disorders at 58 days) and subsequently reached an equal overall incidence to the matched comparison group (mood disorders at 457 days, anxiety disorders at 417 days).

By contrast, risks of cognitive deficit (known as brain fog), dementia, psychotic disorders, and epilepsy or seizures were still increased at the end of the 2-year follow-up period. Post-COVID-19 risk trajectories differed in children compared with adults: in the 6 months after SARS-CoV-2 infection, children were not at an increased risk of mood (HR 1·02 [95% CI 0·94–1·10) or anxiety (1·00 [0·94–1·06]) disorders, but did have an increased risk of cognitive deficit, insomnia, intracranial haemorrhage, ischaemic stroke, nerve, nerve root, and plexus disorders, psychotic disorders, and epilepsy or seizures (HRs ranging from 1·20 [1·09–1·33] to 2·16 [1·46–3·19]). Unlike adults, cognitive deficit in children had a finite risk horizon (75 days) and a finite time to equal incidence (491 days).

A sizeable proportion of older adults who received a neurological or psychiatric diagnosis, in either cohort, subsequently died, especially those diagnosed with dementia or epilepsy or seizures. Risk profiles were similar just before versus just after the emergence of the alpha variant (n=47 675 in each cohort). Just after (vs just before) the emergence of the delta variant (n=44 835 in each cohort), increased risks of ischaemic stroke, epilepsy or seizures, cognitive deficit, insomnia, and anxiety disorders were observed, compounded by an increased death rate. With omicron (n=39 845 in each cohort), there was a lower death rate than just before emergence of the variant, but the risks of neurological and psychiatric outcomes remained similar.

Interpretation: This analysis of 2-year retrospective cohort studies of individuals diagnosed with COVID-19 showed that the increased incidence of mood and anxiety disorders was transient, with no overall excess of these diagnoses compared with other respiratory infections. In contrast, the increased risk of psychotic disorder, cognitive deficit, dementia, and epilepsy or seizures persisted throughout. The differing trajectories suggest a different pathogenesis for these outcomes. Children have a more benign overall profile of psychiatric risk than do adults and older adults, but their sustained higher risk of some diagnoses is of concern. The fact that neurological and psychiatric outcomes were similar during the delta and omicron waves indicates that the burden on the health-care system might continue even with variants that are less severe in other respects. Our findings are relevant to understanding individual-level and population-level risks of neurological and psychiatric disorders after SARS-CoV-2 infection and can help inform our responses to them.

Source: Maxime Taquet, PhD, Rebecca Sillett, BA, Lena Zhu, BS, Jacob Mendel, MMath, Isabella Camplisson, BS, Quentin Dercon, MSc, et al. Open Access Published: August 17, 2022 DOI: https://doi.org/10.1016/S2215-0366(22)00260-7 https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(22)00260-7/fulltext# (Full text)

A core outcome set for post-COVID-19 condition in adults for use in clinical practice and research: an international Delphi consensus study

Abstract:

Health consequences that persist beyond the acute infection phase of COVID-19, termed post-COVID-19 condition (also commonly known as long COVID), vary widely and represent a growing global health challenge. Research on post-COVID-19 condition is expanding but, at present, no agreement exists on the health outcomes that should be measured in people living with the condition.

To address this gap, we conducted an international consensus study, which included a comprehensive literature review and classification of outcomes for post-COVID-19 condition that informed a two-round online modified Delphi process followed by an online consensus meeting to finalise the core outcome set (COS). 1535 participants from 71 countries were involved, with 1148 individuals participating in both Delphi rounds. Eleven outcomes achieved consensus for inclusion in the final COS: fatigue; pain; post-exertion symptoms; work or occupational and study changes; survival; and functioning, symptoms, and conditions for each of cardiovascular, respiratory, nervous system, cognitive, mental health, and physical outcomes. Recovery was included a priori because it was a relevant outcome that was part of a previously published COS on COVID-19.

The next step in this COS development exercise will be to establish the instruments that are most appropriate to measure these core outcomes. This international consensus-based COS should provide a framework for standardised assessment of adults with post-COVID-19 condition, aimed at facilitating clinical care and research worldwide.

Source: Munblit D, Nicholson T, Akrami A, Apfelbacher C, Chen J, De Groote W, Diaz JV, Gorst SL, Harman N, Kokorina A, Olliaro P, Parr C, Preller J, Schiess N, Schmitt J, Seylanova N, Simpson F, Tong A, Needham DM, Williamson PR; PC-COS project steering committee. A core outcome set for post-COVID-19 condition in adults for use in clinical practice and research: an international Delphi consensus study. Lancet Respir Med. 2022 Jun 14:S2213-2600(22)00169-2. doi: 10.1016/S2213-2600(22)00169-2. Epub ahead of print. PMID: 35714658; PMCID: PMC9197249. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9197249/ (Full text)