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1.
BMC Med ; 20(1): 244, 2022 07 06.
Article in English | MEDLINE | ID: covidwho-1923545

ABSTRACT

BACKGROUND: Previous studies assessing the prevalence of COVID-19 sequelae in adults and children were performed in the absence of an agreed definition. We investigated prevalence of post-COVID-19 condition (PCC) (WHO definition), at 6- and 12-months follow-up, amongst previously hospitalised adults and children and assessed risk factors. METHODS: Prospective cohort study of children and adults with confirmed COVID-19 in Moscow, hospitalised between April and August, 2020. Two follow-up telephone interviews, using the International Severe Acute Respiratory and Emerging Infection Consortium survey, were performed at 6 and 12 months after discharge. RESULTS: One thousand thirteen of 2509 (40%) of adults and 360 of 849 (42%) of children discharged participated in both the 6- and 12-month follow-ups. PCC prevalence was 50% (95% CI 47-53) in adults and 20% (95% CI 16-24) in children at 6 months, with decline to 34% (95% CI 31-37) and 11% (95% CI 8-14), respectively, at 12 months. In adults, female sex was associated with PCC at 6- and 12-month follow-up (OR 2.04, 95% CI 1.57 to 2.65) and (OR 2.04, 1.54 to 2.69), respectively. Pre-existing hypertension (OR 1.42, 1.04 to 1.94) was associated with post-COVID-19 condition at 12 months. In children, neurological comorbidities were associated with PCC both at 6 months (OR 4.38, 1.36 to 15.67) and 12 months (OR 8.96, 2.55 to 34.82) while allergic respiratory diseases were associated at 12 months (OR 2.66, 1.04 to 6.47). CONCLUSIONS: Although prevalence of PCC declined one year after discharge, one in three adults and one in ten children experienced ongoing sequelae. In adults, females and persons with pre-existing hypertension, and in children, persons with neurological comorbidities or allergic respiratory diseases are at higher risk of PCC.


Subject(s)
COVID-19 , Hypertension , Adult , COVID-19/epidemiology , Child , Cohort Studies , Female , Hospitals , Humans , Moscow/epidemiology , Patient Discharge , Prevalence , Prospective Studies , Risk Factors
2.
Lancet Respir Med ; 10(7): 715-724, 2022 07.
Article in English | MEDLINE | ID: covidwho-1886188

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.


Subject(s)
COVID-19 , Adult , COVID-19/complications , Delphi Technique , Humans , Outcome Assessment, Health Care , Research Design , Treatment Outcome
3.
Lancet Respir Med ; 10(7): 632-634, 2022 07.
Article in English | MEDLINE | ID: covidwho-1819635
4.
BMC Med ; 20(1): 50, 2022 02 04.
Article in English | MEDLINE | ID: covidwho-1690914

ABSTRACT

BACKGROUND: A substantial portion of people with COVID-19 subsequently experience lasting symptoms including fatigue, shortness of breath, and neurological complaints such as cognitive dysfunction many months after acute infection. Emerging evidence suggests that this condition, commonly referred to as long COVID but also known as post-acute sequelae of SARS-CoV-2 infection (PASC) or post-COVID-19 condition, could become a significant global health burden. MAIN TEXT: While the number of studies investigating the post-COVID-19 condition is increasing, there is no agreement on how this new disease should be defined and diagnosed in clinical practice and what relevant outcomes to measure. There is an urgent need to optimise and standardise outcome measures for this important patient group both for clinical services and for research and to allow comparing and pooling of data. CONCLUSIONS: A Core Outcome Set for post-COVID-19 condition should be developed in the shortest time frame possible, for improvement in data quality, harmonisation, and comparability between different geographical locations. We call for a global initiative, involving all relevant partners, including, but not limited to, healthcare professionals, researchers, methodologists, patients, and caregivers. We urge coordinated actions aiming to develop a Core Outcome Set (COS) for post-COVID-19 condition in both the adult and paediatric populations.


Subject(s)
COVID-19 , Adult , COVID-19/complications , Child , Disease Progression , Humans , Outcome Assessment, Health Care , SARS-CoV-2
5.
SSRN;
Preprint in English | SSRN | ID: ppcovidwho-326233

ABSTRACT

Abstract Background: Recent data suggest that many people experience Post COVID-19 Condition (Long COVID) following the acute phase of the SaRS CoV-2 infection. At present there is no agreement on what patient health outcomes should be measured in Post COVID-19 Condition. We aimed to identify core outcomes for Post COVID-19 Condition that stakeholders considered critical to assess in all research studies and clinical practice. Methods: We conducted a multi-step study: (1) review of outcomes reported in studies of Post COVID-19 Condition to develop a list of potential core outcomes;(2) outcomes were then grouped, using the COMET taxonomy, to present in a consensus process;(3) a two-round online international modified Delphi consensus process, including 3 stakeholder groups (‘people with Post COVID-19 Condition and their carers’, ‘healthcare professionals and researchers’ and ‘healthcare professionals and researchers with Post COVID-19 Condition) to prioritise outcomes;and (4) an international online consensus meeting to finalize the core outcome set. Consensus ‘in’ was defined, a priori, as 80% or more of each stakeholder group rating an outcome as critical (‘7-9’ on a 9-point scale). Patient engagement and global outreach activities were undertaken at all stages of the project. Findings: 1535 participants from 71 countries, representing six continents, were involved in the online modified Delphi process, with 1148 participating in both rounds (75% completion rate). Eleven of 24 outcomes met consensus ‘in’ criteria after the two Delphi rounds and consensus meeting: fatigue or exhaustion;pain;post-exertion symptoms;work/occupational and study changes;survival;and “functioning, symptoms and conditions” for each of the following outcomes: cardiovascular, respiratory, nervous system, cognition, mental and physical. ‘Recovery’ outcome was added ‘a-priori’ as a part of previously published COS on COVID-19. Interpretation: This international study resulted in the development of a COS for Post COVID-19 Condition using a rigorous methodology. The generated consensus-based list of core outcomes should be assessed in clinical research and practice settings. The next step for the development of this COS will be to determine which measurement instruments best measure these outcomes. Funding Information: Funding by the National Institute for Health Research (NIHR) (Grant COV-LT2-0072) supporting the second stage of the process. Declaration of Interests: None to declare.

6.
Critical care (London, England) ; 26(1), 2022.
Article in English | EuropePMC | ID: covidwho-1609363

ABSTRACT

Introduction Survivors of acute respiratory failure (ARF) commonly experience long-lasting physical, cognitive, and/or mental health impairments. Unmet medication needs occurring immediately after hospital discharge may have an important effect on subsequent recovery. Methods and analysis In this multicenter prospective cohort study, we enrolled ARF survivors who were discharged directly home from their acute care hospitalization. The primary exposure was unmet medication needs. The primary outcome was hospital readmission or death within 3 months after discharge. We performed a propensity score analysis, using inverse probability weighting for the primary exposure, to evaluate the exposure–outcome association, with an a priori sample size of 200 ARF survivors. Results We enrolled 200 ARF survivors, of whom 107 (53%) were female and 77 (39%) were people of color. Median (IQR) age was 55 (43–66) years, APACHE II score 20 (15–26) points, and hospital length of stay 14 (9–21) days. Of the 200 participants, 195 (98%) were in the analytic cohort. One hundred fourteen (57%) patients had at least one unmet medication need;the proportion of medication needs that were unmet was 6% (0–15%). Fifty-six (29%) patients were readmitted or died by 3 months;10 (5%) died within 3 months. Unmet needs were not associated (risk ratio 1.25;95% CI 0.75–2.1) with hospital readmission or death, although a higher proportion of unmet needs may have been associated with increased hospital readmission (risk ratio 1.7;95% CI 0.96–3.1) and decreased mortality (risk ratio 0.13;95% CI 0.02–0.99). Discussion Unmet medication needs are common among survivors of acute respiratory failure shortly after discharge home. The association of unmet medication needs with 3-month readmission and mortality is complex and requires additional investigation to inform clinical trials of interventions to reduce unmet medication needs. Study registration number: NCT03738774. The study was prospectively registered before enrollment of the first patient. Supplementary Information The online version contains supplementary material available at 10.1186/s13054-021-03848-3.

8.
Crit Care Med ; 49(10): 1684-1693, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1452742

ABSTRACT

OBJECTIVES: Clinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators. DESIGN: A 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process. PARTICIPANTS: Thirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process. MEASUREMENTS AND MAIN RESULTS: The final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization. CONCLUSIONS: These recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.


Subject(s)
Hypnotics and Sedatives/pharmacokinetics , Hypnotics and Sedatives/therapeutic use , Congresses as Topic , Consensus , Delphi Technique , District of Columbia , Humans , Hypnotics and Sedatives/pharmacology , Respiration, Artificial/instrumentation , Respiration, Artificial/methods , Time Factors
9.
Thorax ; 77(3): 300-303, 2022 03.
Article in English | MEDLINE | ID: covidwho-1443628

ABSTRACT

We report on the outcome of 114 COVID-19-associated acute respiratory distress syndrome (ARDS) survivors evaluated at 3, 6 and 12 months after intensive care unit discharge with assessment of physical, mental and cognitive impairments. Critical illness polyneuromyopathy was diagnosed in 23 patients (39%). Handgrip dynamometry was 70% predicted at 3 months and significantly improved over time, whereas the 6 min walk test (80% predicted) and severe fatigue (27% of patients) did not. Independence in activities of daily living (ADL) was achieved by 98% at 3 months. Cognitive impairment (28% at 3 months) improved over time, whereas depression, anxiety and post-traumatic stress disorder symptoms, present in 9%, 10% and 4% at 3 months, did not. Normalised health-related quality of life was good. COVID-19-associated ARDS leads to persisting impairment in performance-based measures of physical function, while ADL, cognitive and mental health status, and health-related quality of life may be less impaired. Trial registration number NCT04608994.


Subject(s)
COVID-19 , Respiratory Distress Syndrome , Activities of Daily Living , Cognition , Hand Strength , Humans , Outcome Assessment, Health Care , Quality of Life , Respiratory Distress Syndrome/etiology , SARS-CoV-2 , Survivors/psychology
10.
Chest ; 161(2): 407-417, 2022 02.
Article in English | MEDLINE | ID: covidwho-1363120

ABSTRACT

BACKGROUND: Perceived health is one of the strongest determinants of subjective well-being, but it has received little attention among survivors of ARDS. RESEARCH QUESTION: How well do self-reported measures of physical, emotional, and social functioning predict perceived overall health (measured using the EQ-5D visual analog scale [EQ-5D-VAS]) among adult survivors of ARDS? Are demographic features, comorbidity, or severity of illness correlated with perceived health after controlling for self-reported functioning? STUDY DESIGN AND METHODS: We analyzed the ARDSNet Long Term Outcomes Study (ALTOS) and Improving Care of Acute Lung Injury Patients (ICAP) Study, two longitudinal cohorts with a total of 823 survivors from 44 US hospitals, which prospectively assessed survivors at 6 and 12 months after ARDS. Perceived health, evaluated using the EQ-5D-VAS, was predicted using ridge regression and self-reported measures of physical, emotional, and social functioning. The difference between observed and predicted perceived health was termed perspective deviation (PD). Correlations between PD and demographics, comorbidities, and severity of illness were explored. RESULTS: The correlation between observed and predicted EQ-5D-VAS scores ranged from 0.68 to 0.73 across the two cohorts and time points. PD ranged from -80 to +34 and was more than the minimum clinically important difference for 52% to 55% of survivors. Neither demographic features, comorbidity, nor severity of illness were correlated strongly with PD, with |r| < 0.25 for all continuous variables in both cohorts and time points. The correlation between PD at 6- and 12-month assessments was weak (ALTOS: r = 0.22, P < .001; ICAP: r = 0.20, P = .02). INTERPRETATION: About half of survivors of ARDS showed clinically important differences in actual perceived health vs predicted perceived health based on self-reported measures of functioning. Survivors of ARDS demographic features, comorbidities, and severity of illness were correlated only weakly with perceived health after controlling for measures of perceived functioning, highlighting the challenge of predicting how individual patients will respond psychologically to new impairments after critical illness.


Subject(s)
Respiratory Distress Syndrome/therapy , Survivors/psychology , Adult , Critical Illness , Female , Humans , Longitudinal Studies , Male , Middle Aged , Prospective Studies , Self Report , United States
11.
J Clin Epidemiol ; 137: 126-132, 2021 09.
Article in English | MEDLINE | ID: covidwho-1171627

ABSTRACT

OBJECTIVE: This structured methodology review evaluated statistical approaches used in randomized controlled trials (RCTs) enrolling patients at high risk of death and makes recommendations for reporting future RCTs. STUDY DESIGN AND SETTING: Using PubMed, we searched for RCTs published in five general medicine journals from January 2014 to August 2019 wherein mortality was ≥10% in at least one randomized group. We abstracted primary and secondary outcomes, statistical analysis methods, and patient samples evaluated (all randomized patients vs. "survivors only"). RESULTS: Of 1947 RCTs identified, 434 met eligibility criteria. Of the eligible RCTs, 91 (21%) and 351 (81%) had a primary or secondary functional outcome, respectively, of which 36 (40%) and 263 (75%) evaluated treatment effects among "survivors only". In RCTs that analyzed all randomized patients, the most common methods included use of ordinal outcomes (e.g., modified Rankin Scale) or creating composite outcomes (primary: 41 of 91 [45%]; secondary: 57 of 351 [16%]). CONCLUSION: In RCTs enrolling patients at high risk of death, statistical analyses of functional outcomes are frequently conducted among "survivors only," for which conclusions might be misleading. Given the growing number of RCTs conducted among patients hospitalized with COVID-19 and other critical illnesses, standards for reporting should be created.


Subject(s)
Critical Illness/therapy , Randomized Controlled Trials as Topic/methods , Research Design/standards , Survivors , COVID-19/mortality , COVID-19/therapy , Critical Illness/mortality , Humans , Risk Assessment/statistics & numerical data , Treatment Outcome
12.
Am J Otolaryngol ; 42(3): 102917, 2021.
Article in English | MEDLINE | ID: covidwho-1064785

ABSTRACT

Mortality from COVID-19 has obscured a subtler crisis - the swelling ranks of COVID-19 survivors. After critical illness, patients often suffer post-intensive care syndrome (PICS), which encompasses physical, cognitive, and/or mental health impairments that are often long-lasting barriers to resuming a meaningful life. Some deficits after COVID-19 critical illness will require otolaryngologic expertise for years after hospital discharge. There are roles for all subspecialties in preventing, diagnosing, or treating sequelae of COVID-19. Otolaryngologist leadership in multidisciplinary efforts ensures coordinated care. Timely tracheostomy, when indicated, may shorten the course of intensive care unit stay and thereby potentially reduce the impairments associated with PICS. Otolaryngologists can provide expertise in olfactory disorders; thrombotic sequelae of hearing loss and vertigo; and laryngotracheal injuries that impair speech, voice, swallowing, communication, and breathing. In the aftermath of severe COVID-19, otolaryngologists are poised to lead efforts in early identification and intervention for impairments affecting patients' quality of life.


Subject(s)
COVID-19/complications , Critical Illness/therapy , Otolaryngologists , Otorhinolaryngologic Diseases/etiology , Otorhinolaryngologic Diseases/therapy , Quality of Life , Survivorship , Critical Care/methods , Humans , Intensive Care Units , SARS-CoV-2
13.
Crit Care Med ; 49(3): 503-516, 2021 03 01.
Article in English | MEDLINE | ID: covidwho-1010657

ABSTRACT

OBJECTIVES: Respiratory failure, multiple organ failure, shortness of breath, recovery, and mortality have been identified as critically important core outcomes by more than 9300 patients, health professionals, and the public from 111 countries in the global coronavirus disease 2019 core outcome set initiative. The aim of this project was to establish the core outcome measures for these domains for trials in coronavirus disease 2019. DESIGN: Three online consensus workshops were convened to establish outcome measures for the four core domains of respiratory failure, multiple organ failure, shortness of breath, and recovery. SETTING: International. PATIENTS: About 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Respiratory failure, assessed by the need for respiratory support based on the World Health Organization Clinical Progression Scale, was considered pragmatic, objective, and with broad applicability to various clinical scenarios. The Sequential Organ Failure Assessment was recommended for multiple organ failure, because it was routinely used in trials and clinical care, well validated, and feasible. The Modified Medical Research Council measure for shortness of breath, with minor adaptations (recall period of 24 hr to capture daily fluctuations and inclusion of activities to ensure relevance and to capture the extreme severity of shortness of breath in people with coronavirus disease 2019), was regarded as fit for purpose for this indication. The recovery measure was developed de novo and defined as the absence of symptoms, resumption of usual daily activities, and return to the previous state of health prior to the illness, using a 5-point Likert scale, and was endorsed. CONCLUSIONS: The coronavirus disease 2019 core outcome set recommended core outcome measures have content validity and are considered the most feasible and acceptable among existing measures. Implementation of the core outcome measures in trials in coronavirus disease 2019 will ensure consistency and relevance of the evidence to inform decision-making and care of patients with coronavirus disease 2019.


Subject(s)
COVID-19/epidemiology , COVID-19/prevention & control , Clinical Trials as Topic , Outcome Assessment, Health Care/standards , Practice Guidelines as Topic , Research Design , Dyspnea , Humans , Multiple Organ Failure , Recovery of Function , Reproducibility of Results , Respiratory Insufficiency
14.
Arch Phys Med Rehabil ; 101(12): 2233-2242, 2020 12.
Article in English | MEDLINE | ID: covidwho-878828

ABSTRACT

Recognizing a need for more guidance on the coronavirus disease 2019 (COVID-19) pandemic, members of the Archives of Physical Medicine and Rehabilitation Editorial Board invited several clinicians with early experience managing the disease to collaborate on a document to help guide rehabilitation clinicians in the community. This consensus document is written in a "question and answer" format and contains information on the following items: common manifestations of the disease; rehabilitation recommendations in the acute hospital setting, recommendations for inpatient rehabilitation and special considerations. These suggestions are intended for use by rehabilitation clinicians in the inpatient setting caring for patients with confirmed or suspected COVID-19. The text represents the authors' best judgment at the time it was written. However, our knowledge of COVID-19 is growing rapidly. The reader should take advantage of the most up-to-date information when making clinical decisions.


Subject(s)
COVID-19/rehabilitation , Physical and Rehabilitation Medicine/organization & administration , COVID-19/physiopathology , Communication , Cooperative Behavior , Humans , Infection Control/standards , Inpatients , Patient Care Team/organization & administration , Physical and Rehabilitation Medicine/standards , Practice Guidelines as Topic , SARS-CoV-2 , Triage/standards
15.
Curr Opin Crit Care ; 26(5): 489-499, 2020 10.
Article in English | MEDLINE | ID: covidwho-708833

ABSTRACT

PURPOSE OF REVIEW: Given the growing body of critical care clinical research publications, core outcome sets (COSs) are important to help mitigate heterogeneity in outcomes assessed and measurement instruments used, and have potential to reduce research waste. This article provides an update on COS projects in critical care medicine, and related resources and tools for COS developers. RECENT FINDINGS: We identified 28 unique COS projects, of which 15 have published results as of May 2020. COS topics relevant to critical care medicine include mechanical ventilation, cardiology, stroke, rehabilitation, and long-term outcomes (LTOs) after critical illness. There are four COS projects for coronavirus disease 2019 (COVID-19), with a 'meta-COS' summarizing common outcomes across these projects. To help facilitate COS development, there are existing resources, standards, guidelines, and tools available from the Core Outcome Measures in Effectiveness Trials Initiative (www.comet-initiative.org/) and the National Institutes of Health-funded Improve LTO project (www.improvelto.com/). SUMMARY: Many COS projects have been completed in critical care, with more on-going COS projects, including foci from across the spectrum of acute critical care, COVID-19, critical care rehabilitation, and patient recovery and LTOs. Extensive resources are accessible to help facilitate rigorous COS development.


Subject(s)
Coronavirus Infections , Critical Illness , Pandemics , Pneumonia, Viral , Research Design , Betacoronavirus , COVID-19 , Cardiology , Delphi Technique , Humans , Respiration, Artificial , SARS-CoV-2 , Stroke Rehabilitation
16.
Phys Ther ; 100(7): 1062-1073, 2020 07 19.
Article in English | MEDLINE | ID: covidwho-680630

ABSTRACT

More than 4 million adults survive a stay in the intensive care unit each year, with many experiencing new or worsening physical disability, mental health problems, and/or cognitive impairments, known as post-intensive care syndrome (PICS). Given the prevalence and magnitude of physical impairments after critical illness, many survivors, including those recovering from COVID-19, could benefit from physical therapist services after hospital discharge. However, due to the relatively recent recognition and characterization of PICS, there may be limited awareness and understanding of PICS among physical therapists practicing in home health care and community-based settings. This lack of awareness may lead to inappropriate and/or inadequate rehabilitation service provision. While this perspective article provides information relevant to all physical therapists, it is aimed toward those providing rehabilitation services outside of the acute and postacute inpatient settings. This article reports the prevalence and clinical presentation of PICS and provides recommendations for physical examination and outcomes measures, plan of care, and intervention strategies. The importance of providing patient and family education, coordinating community resources including referring to other health care team members, and community-based rehabilitation service options is emphasized. Finally, this perspective article discusses current challenges for optimizing outcomes for people with PICS and suggests future directions for research and practice.


Subject(s)
Chronic Disease/rehabilitation , Critical Care , Critical Illness/rehabilitation , Home Care Services , Patient Discharge , Physical Therapy Modalities , Betacoronavirus , COVID-19 , Cognitive Dysfunction/etiology , Cognitive Dysfunction/rehabilitation , Coronavirus Infections , Humans , Pandemics , Pneumonia, Viral , SARS-CoV-2
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