Core Outcome Measurement Set for Research and Clinical Practice in [Long COVID] in Children and Young People: “PC-COS Children”, 2024, Seylanova et al

Core Outcome Measurement Set for Research and Clinical Practice in Post COVID-19 Condition Long COVID in Children and Young People: An International Delphi Consensus Study “PC-COS Children”
Nina Seylanova; Anastasia Chernyavskaya; Natalia Degtyareva; Aigun Mursalova; Ali Ajam; Lin Xiao; Khazhar Aktulaeva; Philipp Roshchin; Polina Bobkova; Olalekan Lee Aiyegbusi; Anbarasu Theodore Anbu; Christian Apfelbacher; Ali Akbar Asadi-Pooya; Liat Ashkenazi-Hoffnung; Caroline Brackel; Danilo Buonsenso; Wouter de Groote; Janet V. Diaz; Daniele Dona; Audrey Dunn Galvin; Jon Genuneit; Helen Goss; Sarah E. Hughes; Christina J. Jones; Krutika Kuppalli; Laura A. Malone; Sammie McFarland; Dale M. Needham; Nikita Nekliudov; Timothy R Nicholson; Carlos R. Oliveira; Nicoline Schiess; Terry Y Segal; Louise Sigfrid; Claire Thorne; Susanne Vijverberg; John O. Warner; Wilson Milton Were; Paula R. Williamson; Daniel Munblit; the PC-COS Children Study Group

The COVID-19 pandemic substantially impacted different age groups, with children and young people (CYP) not exempted. Many have experienced enduring health consequences. Presently, there is no consensus on the health outcomes to assess in CYP with post COVID-19 condition. Furthermore, it is unclear which measurement instruments are appropriate for use in research and clinical management of CYP with post-COVID-19.

To address these unmet needs, we conducted a consensus study, aiming to develop a core outcome set (COS) and an associated core outcome measurement set (COMS) for evaluating post-COVID-19 condition in CYP. Our methodology comprised of two phases. In phase 1 (to create a COS), we performed an extensive literature review and categorisation of outcomes, and prioritised those outcomes in a two-round online modified Delphi process followed by a consensus meeting. In phase 2 (to create the COMS), we performed another modified Delphi consensus process to evaluate measurement instruments for previously defined “core outcomes” from phase 1, followed by an online consensus workshop to finalise recommendations regarding the most appropriate instruments for each core outcome. In phase 1, 214 participants from 37 countries participated, with 154 (72%) contributing to both Delphi rounds.

The subsequent online consensus meeting resulted in a final COS which encompassed seven critical outcomes: fatigue; post-exertion symptoms; work/occupational and study changes; as well as functional changes, symptoms, and conditions relating to cardiovascular, neuro-cognitive, gastrointestinal, and physical outcomes. In phase 2, 11 international experts were involved in a modified Delphi process, selecting measurement instruments for a subsequent online consensus workshop where 30 voting participants discussed and independently scored the selected instruments.

As a result of this consensus process, four instruments met a priori consensus criteria for inclusion: “PedsQL multidimensional Fatigue scale” for “fatigue”; “PedsQL Gastrointestinal symptom scales” for “gastrointestinal”; “PedsQL Cognitive Functioning Scale” for “Neuro-cognitive” and “EQ5D family” for “physical functioning”. Despite proposing outcome measurement instruments for the remaining three core outcomes (“cardiovascular”, “post-exertional malaise”, “work/occupational and study changes”), a consensus was not achieved.

Our international, consensus-based initiative presents a robust framework for evaluating post-COVID-19 condition in CYP in research and clinical practice via a rigorously defined COS and associated COMS. It will aid in the uniform measurement and reporting of relevant health outcomes worldwide.


Link | PDF (European Respiratory Journal)

 

Summary of additional comments from the experts in rounds 1/2: Chalder fatigue questionnaire —

 

3.3 Fatigue or exhaustion outcome measures —

 

3.4 Post-exertion symptoms outcome measures —

 

Ugh. Talk about missing the point. The CFQ is her work, and it's terrible, that's why it's controversial. It's not about her, it's that her work is bad, the CFQ is bad and is not applicable here. And it's not established for ME/CFS, but the idea that a terrible questionnaire about fatigue doesn't adequately capture the Long Covid population is the exact same controversy: her stuff is terrible and misleading. If she did one competent thing it would be accepted without reservation, but nothing she ever worked isn't garbage of no interest.

At least some of the later discussion expands on this, but this is really basically a discussion on ME/CFS in all but name. The exact same issues, including the terrible quality of some of the work that has distorted understanding of the illness. And although it's mostly about pediatric patients, the exact same issues remain, maybe with substituting with education vs work, but then again pediatrics is about children so there's still a large % of patients with these issues, so that makes it a really tiny difference of little importance.

There is a recent questionnaire built around this. I think about Long Covid. Published not too long ago, no more than a year.

We've been saying this stuff for decades, FFS.