In progress: Measuring Health in Children with CFS/ME: Refinement, application and evaluation of new PROM (PEACH) in routine practice, Crawley et al

Funded study in progress.

Abstract:

Background: Paediatric Chronic Fatigue Syndrome or Myalgic Encaphalistis (CFS/ME) is disabling and relatively common (1-2% of teenagers). We need to improve treatment but need a well developed Patient Reported Outcome Measure (PROM) to do this. Clinical services and randomised controlled trials use a variety of PROMs but they are largely of poor quality with limited relevance to children s experience of CFS/ME. We have completed the first stage in developing a child-centred measure: Prom Evaluating Adolescent and Child cHronic fatigue (PEACH). However, this contains 63 questions and is too long to be used.

Aims: Create a high quality, relevant, acceptable child-reported PROM for paediatric CFS/ME called PEACH-Short form (PEACH-SF). Objective 1: Refine PEACH-63 to construct PEACH-SF.

Objective 2: Check the acceptability and relevance of PEACH-SF. Objective 3: Evaluate the quality, validity, acceptability, reliability and responsiveness of PEACH-SF. Methods: Phase 1:

Objective 1. Refining PEACH-63. We will recruit 313 children from the Bath Specialist paediatric CFS/ME service and the London Specialist paediatric service to complete PEACH-63 once. This will provide data on >250 children. We will collect questionnaire data online and use both traditional and modern psychometric analyses to perform psychometric evaluation. We will describe measurement data quality, the internal structure of the measure, identify those questions which contribute best which will enable us to reduce the number of questions producing PEACH-short form (PEACH-SF), of approximately 20 questions.

Objective 2: We will check the acceptability and relevance of PEACH-SF by interviewing participants (approximately 10) on whether we have retained content and face validity. We will observe approximately 10 children and young people complete PEACH-SF using Usability Testing Software and we will discuss PEACH-SF with the CFS/ME Young Peoples Advisory Group. Phase 2 (Field test 2)

Objective 3. We will recruit a further 313 children and young people (ensuring we have data on >250) to complete PEACH-SF ( approximately 20 questions) at baseline, 2 weeks later (to check temporal stability) and 6 months later (to check measurement responsiveness). We will collect the Clinical Global Improvement Scale (CGI, 1 item) at both time points and the SF-36 physical function short form at 6 months.

Timelines for delivery: Month 10: Field testing 1 complete. Month 14: PEACH-SF complete. Month 28: Field testing 2 complete. Month 31: Psychometric analyses complete and PEACH-SF ready for use. Impact and Dissemination: Short term impact – improved clinical care as PEACH-SF will be used immediately at the end of this study. Medium to long term impact – improved research in paediatric CFS/ME leading to improved treatments.

Dissemination: To ensure PEACH-SF is used throughout the NHS, we will work with the British Association for CFS/ME to disseminate to paediatric CFS/ME services, and the AHSN to disseminate to paediatric services and inform NICE. We will publish, and work with the press office to ensure researchers and the public are aware of PEACH-SF.

Chief Investigator(s):
Professor Esther Crawley

Co-investigators:
Dr Kirstie Haywood, Dr Roxanne Parslow, Dr Terry Segal

Award:
£149,457.00

Start Date:
February 2020

End Date:
September 2022

https://fundingawards.nihr.ac.uk/award/NIHR200509

 

UGH!
(Any other comments I have are unpublishable.... And seriously? PEACH? Crawley should not be associated in any way with one of the best of summer's offerings!)

 

Should we start a petition demanding that Prof Crawley be limited to only one acronym a year, though even that is one to many.

 

Is this the first questionnaire used for ME/CFS patients where they have bothered (or are planning) to test face validity?

 

BACME

to coin an american term, peachy

 

Where is the public funding coming from? It might be worth challenging the funding body --- is there a subjective [questionnaire] and an objective [actimetry - electronic activity monitoring] outcome indicator?

 

And of course the NIHR is a labryinthine organisation that reports to the Department of Health and Social Care.

There seems to be an NGO liaison group that is intermediary to NIRH and D of H:

https://www.lgcgroup.com/health-research-programme-management/

Under the 'Who we serve":

We manage schemes for a variety of funders including the successful outsourced public sector research programmes for the UK Government. Each scheme has different objectives and requirements, ranging from low cost, single studies, to multi-million pound investments involving complex collaborations and arrangements.

https://www.lgcgroup.com/who-grant-management-serve/

My cognitive capacities get rather challenged by large webs of links that feed back to each other. So feel free anyone to check for accuracy.

But I think it's worth us knowing what is going on and how it's getting done.

 

There's a Parliamentary (scrutiny) Committee - they have powers to calls "persons and papers" (roughly). So e.g. they can call senior officials in the Department to explain this. Also, the Committee can scrutinise the funding policy/decisions.

Another route is a Parliamentary question.

If you look at

• the "outcome" of this "research" is it stigmatising --- all in the mind
• this research is it systemically flawed (unblinded studies with subject outcome indicators?) can you link this to the "criticisms" i.e. NICE review downgrading unblinded studies with subject outcome indicators?

 

Yea, and the draft NICE Guidelines were published in November last year, so much for the Secretary of State [AKA - Minister] for Health and Social Care reassurance (in June this year) that there was a "robust peer review processes"* in place. So robust in fact that they awarded this grant despite the draft NICE Guidance finding that these studies were low/very low quality.

*https://questions-statements.parliament.uk/written-questions/detail/2021-06-29/24368/

 

But it's got a snazzy name! Isn't that what seems to attract the funding?

 

Maybe they need some alternatives, like PUKE, or VOMIT, or RETCH OUT.