Core Outcome Set for Research and Clinical Practice in Post COVID-19 Condition (Long COVID): An International Delphi Consensus Study ‘PC-COS’

Munblit, Daniel; Nicholson, Timothy; Akrami, Athena; Apfelbacher, Christian; Chen, Jessica; Groote, Wouter De; Dı́az, Janet; Gorst, Sarah L.; Harman, Nicola; Kokorina, Alisa; Olliaro, Piero; Parr, Callum; Preller, Jacobus; Schiess, Nicoline; Schmitt, Jochen; Seylanova, Nina; Simpson, Frances; Tong, Allison; Williamson, Paula; Committee, PC-COS Project Steering

doi:10.2139/ssrn.4017375

Cited by 12 publications

(9 citation statements)

References 5 publications

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“…We initially defined four core outcome measures (health-related quality of life, organ-specific symptoms or sequelae, timing and duration of symptoms, and functionality) that we would modify according to the results of the new Core Outcome Set, which was published on 31 January 2022 [ 21 ]. Based on this core outcome set and the input of Long-COVID-19 Deutschland [ 22 ], we reframed the outcomes of interest of this review to the following: Cardiovascular functioning: including symptoms and conditions (i.e., chest pain, arrhythmias, heart failure, ischaemic heart disease, and postural hypotension/tachycardia); Fatigue or Exhaustion; Pain: localised pain (headache), neuropathic pain, and muscle/joint pain; Nervous system functioning: symptoms and conditions (vertigo, dizziness, and paraesthesias/numbness); Cognitive functioning: symptoms and conditions, and systematic assessments of cognitive functioning; Mental functioning: symptoms and conditions, including but not limited to depression, anxiety, post-traumatic stress disorder, and emotional distress, among others; Respiratory functioning: symptoms (e.g., dyspnoea) and conditions, and systematic assessments of respiratory function (i.e., FEV1, FVC); Post-exertion symptoms; Health-related quality of life: including measurements of physical-mental-social functioning (SF-36 or EuroQOL or other related scales); Changes in work/occupation and studies (school attendance); Survival related to long-COVID-19 (i.e., not overall survival related to infection, but to the presence of persistent or new long-term symptoms or sequelae); Recovery/duration of symptoms; Need for rehabilitation/resource use; Other complications/sequelae: metabolic, autoimmune, or others.…”

Section: Methodsmentioning

confidence: 99%

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Long-Term Health Symptoms and Sequelae Following SARS-CoV-2 Infection: An Evidence Map

Franco

Garegnani

Oltra

et al. 2022

IJERPH

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Post-COVID-19 conditions, also known as ‘Long-COVID-19’, describe a longer and more complex course of illness than acute COVID-19 with no widely accepted uniform case definition. We aimed to map the available evidence on persistent symptoms and sequelae following SARS-CoV-2 in children and adults. We searched the Cochrane COVID-19 Study Register and the WHO COVID-19 Global literature on coronavirus disease database on 5 November 2021. We included longitudinal and cross-sectional studies and we extracted their characteristics, including the type of core outcomes for post-COVID-19 conditions. We included 565 studies (657 records). Most studies were uncontrolled cohort studies. The median follow-up time was 13 weeks (IQR 9 to 24). Only 72% of studies were conducted in high-income countries, 93% included unvaccinated adults with mild-to-critical disease, only 10% included children and adolescents, and less than 5% included children under the age of five. While most studies focused on health symptoms, including respiratory symptoms (71%), neurological symptoms (57%), fatigue (54%), pain (50%), mental functioning (43%), cardiovascular functioning (40%), and post-exertion symptoms (28%), cognitive function (26%), fewer studies assessed other symptoms such as overall recovery (24%), the need for rehabilitation (18%), health-related quality of life (16%), changes in work/occupation and study (10%), or survival related to long-COVID-19 (4%). There is a need for controlled cohort studies with long-term follow-up and a focus on overall recovery, health-related quality of life, and the ability to perform daily tasks. Studies need to be extended to later phases of the pandemic and countries with low resources.

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Section: Methodsmentioning

confidence: 99%

“…The first 12 outcomes match the Core Outcome Set [ 21 ] except for “9. Physical functioning, symptoms, and conditions”, which we replaced with the wider concept of “Health-related Quality of Life” (which includes physical-mental-social functioning).…”

Section: Methodsmentioning

confidence: 99%

Long-Term Health Symptoms and Sequelae Following SARS-CoV-2 Infection: An Evidence Map

Franco

Garegnani

Oltra

et al. 2022

IJERPH

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“…The PCFS scale was included as a potential outcome measurement instrument in a similar Delphi process (Post-COVID-19 Condition Core Outcome Set [PC-COS] study, available via PC-COS.org), as it was thought to measure relevant outcome domain(s) part of the core outcome set developed for post-COVID-19 condition. 78 However, no consensus was reached, for multiple domains, as to which tool was best to assess these domains. The PCFS scale was ultimately not included as one of the recommended instruments to assess multiple domains, as preference was given to more established tools such as the SF-36, EQ-5D, and WHO Disability Assessment Schedule 2.0.…”

Section: Clinical Applicationmentioning

confidence: 99%

The Post–Venous Thromboembolism Functional Status Scale: From Call to Action to Application in Research, Extension to COVID-19 Patients, and Its Use in Clinical Practice

Jong

Boon

et al. 2023

Semin Thromb Hemost

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A broad spectrum of long-term sequelae may be present in venous thromboembolism (VTE) survivors, affecting their quality of life and functioning. To monitor recovery and improve the prognosis of patients with persistent functional limitations, the development of a new outcome measure that could better capture the consequences of VTE was an unmet need. Starting as a call to action, the Post-VTE Functional Status (PVFS) scale was developed to meet this need. The PVFS scale is an easy-to-use clinical tool to measure and quantify functional outcomes after VTE by focusing on key aspects of daily life. As the scale was considered useful in coronavirus disease 2019 (COVID-19) patients as well, the Post-COVID-19 Functional Status (PCFS) scale was introduced early in the pandemic after slight adaptation. The scale has been well incorporated into both the VTE and COVID-19 research communities, contributing to the shift of focus toward patient-relevant functional outcomes. Psychometric properties have been evaluated, mainly for the PCFS scale but recently also for the PVFS scale, including validation studies of translations, showing adequate validity and reliability. In addition to serving as outcome measure in studies, guidelines and position papers recommend using the PVFS and PCFS scale in clinical practice. As broad use of the PVFS and PCFS scale in clinical practice is valuable to capture what matters most to patients, widespread implementation is a crucial next step. In this review, we discuss the development of the PVFS scale and introduction in VTE and COVID-19 care, the incorporation of the scale in research, and its application in clinical practice.

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“…Derzeit wird in einem internationalen Delphi-Prozess an einem Core-Outcome-Set für Post-COVID gearbeitet 41 .…”

Section: Analyse Systematischer Reviewsunclassified

Post-COVID: Alles eine Frage der Definition?

Lemhöfer

Appel

Haüser

et al. 2022

Dtsch Med Wochenschr

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ZusammenfassungDie Prävalenz des Post-COVID-Syndroms (PCS) ist noch nicht abschließend geklärt. Die bisherigen Definitionen bilden vorrangig zeitliche Aspekte ab, lassen jedoch funktionelle Defizite sowie die Objektivierung von Symptomen außer Acht. Dies führt zu diagnostischen sowie therapeutischen Unklarheiten. In Pubmed wurde daher nach systematischen Reviews gesucht, die sich mit den Folgen einer SARS-CoV-2-Infektion befassten. Die zugrunde liegenden Definitionen sowie zeitlichen Einschlusskriterien wurden extrahiert. 16 systematische Reviews wurden eingeschlossen, davon 11 mit einer Definition des PCS. In 58 % der analysierten Einzelstudien wurden Patienten mit einer Symptomatik > 12 Wochen und damit entsprechend der Definition des PCS inkludiert. Fazit: Eine weitere Präzisierung der Definition des PCS ist notwendig, um Diagnostik und eine multimodale Behandlung zu erleichtern und die knappen therapeutischen Ressourcen entsprechend zu nutzen.

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Core Outcome Set for Research and Clinical Practice in Post COVID-19 Condition (Long COVID): An International Delphi Consensus Study ‘PC-COS’

Cited by 12 publications

References 5 publications

Long-Term Health Symptoms and Sequelae Following SARS-CoV-2 Infection: An Evidence Map

Long-Term Health Symptoms and Sequelae Following SARS-CoV-2 Infection: An Evidence Map

The Post–Venous Thromboembolism Functional Status Scale: From Call to Action to Application in Research, Extension to COVID-19 Patients, and Its Use in Clinical Practice

Post-COVID: Alles eine Frage der Definition?

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