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

Munblit, Daniel; Nicholson, Timothy R; 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; Needham, Dale M.; Williamson, Paula; Guekht, Alla; Semple, Malcolm; Warner, John O.; Sigfrid, Louise; Scott, Janet T.; DunnGalvin, Audrey; Genuneit, Jon; Buonsenso, Danilo; Sivan, Manoj; Siegerink, Bob; Klok, Frederikus A.; Авдеев, С. Н.; Stavropoulou, Charitini; Michelen, Melina; Aiyegbusi, Olalekan Lee; Calvert, Melanie; Hughes, Sarah; Haroon, Shamil; Fregonese, Laura; Carson, Gail; Knauß, Samuel; O’Hara, Margaret; Marshall, John M.; Herridge, Margaret S.; Murthy, Srinivas; Vos, Theo; Hanson, Sarah Wulf; Parker, Ann M.; O’Brien, Kelly K; Lerner, Andrea M; Chevinsky, Jennifer; Unger, Elizabeth R.; Eisinger, Robert W.; Hough, Catherine L.; Saydah, Sharon; Frontera, Jennifer A.; Rosa, Régis Goulart; Cao, Bin; Bhatnagar, Shinjini; Thiruvengadam, Ramachandran; Seahwag, Archana; Bouraoui, Anouar; Kerkhove, Maria D. Van; Dua, Tarun; Relan, Pryanka; Ortiz, Juan Soriano

doi:10.1016/s2213-2600(22)00169-2

Cited by 133 publications

(134 citation statements)

References 24 publications

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“…Due to limited knowledge and emerging evidence, defining outcomes in this context has been challenging, leading to substantial heterogeneity across studies. Recently, a core outcome set for assessing post COVID-19 condition was suggested, informed by frequently reported symptoms in the literature and a multi-stakeholder modified Delphi process (17). The outcome measures used in our study are consistent with these recommendations.…”

Section: Discussionmentioning

confidence: 99%

“…In the absence of an established core outcome set for post COVID-19 condition, we determined outcomes based on commonly reported patient-relevant health measures and symptoms (17,20).…”

Section: Methodsmentioning

confidence: 99%

“…Additionally, most studies lacked a comparison with a comparator group, and their findings were often scrutinized as many reported symptoms were non-specific and common in the general population without infection. Furthermore, limited knowledge and the lack of consensus on core outcomes regarding post COVID-19 condition has led to the use of various outcome measures and inconsistent symptom definitions across observational studies affecting their comparability (17). This also impairs the interpretation of future trials of interventions aiming to improve post COVID-19 condition and their translation into healthcare policy and clinical practice.…”

Section: Introductionmentioning

confidence: 99%

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Natural course of post COVID-19 condition and implications for trial design and outcome selection: A population-based longitudinal cohort study

Menges

Anagnostopoulos

Domenghino

et al. 2022

Preprint

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Background: Evidence from population-based studies on the longer-term natural course of post COVID-19 condition is limited, but crucial for informing patients and healthcare providers and for effectively designing clinical trials. Objectives: To evaluate longer-term symptoms and health outcomes within a cohort of SARS-CoV-2 infected individuals. Design: Population-based, longitudinal cohort. Setting: General population, Canton of Zurich, Switzerland. Patients: 1543 adults with confirmed SARS-CoV-2 infection and 628 adults without infection. Measurements: Changes in self-reported health status over time, factors associated with persistence of non-recovery, and prevalence and excess risk of symptoms at 6 and 12 months post-infection compared to non-infected individuals. Results: 25% of SARS-CoV-2 infected individuals did not recover by 6 months. Of those, 67% and 58% also did not recover at 12 and 18 months after infection, respectively. Hospitalization for acute COVID-19, pre-existing fatigue and pain or discomfort, and presence of specific systemic, cardiovascular, or musculoskeletal symptoms at 6 months were associated with persistent non-recovery. Symptom prevalence was higher among infected individuals compared to non-infected individuals at 6 months (adjusted risk difference (aRD)=17%) and 12 months (aRD=20%). aRDs for individual symptoms ranged from 2% to 12%, with the highest excess risks observed for altered taste or smell, post-exertional malaise, fatigue, and reduced concentration and memory. Limitations: We relied on self-reported assessments and did not assess the effects of vaccination or infection with emerging variants of concern. Conclusion: These findings emphasize the need for effective interventions to reduce the burden of post COVID-19 condition. They further demonstrate the importance of using multiple outcome measures and of considering the expected rates of natural recovery and heterogenous patient trajectories in the design and interpretation of clinical trials.

show abstract

Section: Discussionmentioning

confidence: 99%

“…In the absence of an established core outcome set for post COVID-19 condition, we determined outcomes based on commonly reported patient-relevant health measures and symptoms (17,20).…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Natural course of post COVID-19 condition and implications for trial design and outcome selection: A population-based longitudinal cohort study

Menges

Anagnostopoulos

Domenghino

et al. 2022

Preprint

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show abstract

“…This seminal cataloguing of symptoms has been supplanted by the urgency to develop a core outcome set (COS) to ensure uniform capture of critically important symptoms for post-COVID-19 clinical research studies. Daniel Munblit and colleagues, 2 using a rigorous Delphi consensus methodology and prespecified criteria for outcome inclusion, have developed a COS for symptoms of the post-COVID-19 condition that include: fatigue; pain; post-exertion symptoms; work or occupational and study changes; survival; “functioning, symptoms, and conditions” for each of cardiovascular, respiratory, nervous system, cognitive, mental health, and physical outcomes; and recovery. A strength of their study was the recruitment of a diverse and multidisciplinary investigator group and inclusion of those with lived experience of post-COVID-19 condition and their carers.…”

mentioning

confidence: 99%

The COVID-19 continuum of illness

Herridge¹,

Azoulay²

2022

The Lancet Respiratory Medicine

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“…Consensus on the outcomes is typically reached with involvement of all relevant stakeholders, including people with lived experience and their families, researchers, and health-care professionals. A Position Paper 5 in The Lancet Respiratory Medicine outlines a long-awaited list of core outcomes that such stakeholder groups agreed are essential for assessment of adults with post-COVID-19 condition in research and clinical settings. Growing evidence also suggests an urgent need to develop a COS for post-COVID-19 condition in children and young people 6 to ensure that domains or outcomes that have specific importance to this group are not missed.…”

mentioning

confidence: 99%