The Future Challenges: Replenish-ME

Contextual questions to help identify higher-risk DHTs

Table 2 Contextual questions to help identify higher-risk DHTs
Question
Risk adjustment
Are the intended users of the DHT considered to be in a potentially vulnerable group such as children or at-risk adults?
NHS England defines an at-risk adult as an adult ‘who may be in need of community care services by reason of mental or other disability, age or illness; and who is or may be unable to take care of him or herself, or unable to protect him or herself against significant harm or exploitation.’ If the DHT is intended to be used by people considered to be in a potentially vulnerable group then a higher level of evidence may be needed, or relevant expert opinion on whether the needs of the users are being appropriately addressed.
How serious could the consequences be to the user if the DHT failed to perform as described?
A higher level of potential harm may indicate that the best practice evidence standards should be used.
Is the DHT intended to be used with regular support from a suitably qualified and experienced health or social care professional?
DHTs that are intended to be used with support (that is, with regular support or guidance from a suitably qualified and experienced health or social care professional) could be considered to have lower risk than DHTs that are intended to be used by the patient on their own. This contextual question may require careful interpretation depending on the individual DHT as the involvement of a clinician may in itself indicate that the DHT presents a specific risk.
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Acceptability with users.
Be able to show that representatives from intended user groups were involved in the design, development or testing of the DHT. Provide data to show user satisfaction with the DHT.
Published or publically available evidence to show that representatives from intended user groups were involved in the design, development or testing of the DHT and to show that users are satisfied with the DHT.
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Use of appropriate behaviour change techniques (if relevant).
Be able to show that the techniques used in the DHT are:
• consistent with recognised behaviour change theory and recommended practice (aligned to guidance from NICE or relevant professional organisations)
• appropriate for the target population.
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https://www.nice.org.uk/about/what-...rds-framework-for-digital-health-technologies

are they aware that NICE is currently completely reviewing the ME/CFS guidelines. Might it not be prudent to wait and see what they are?
Are the company aware of the statistics (patient surveys) of the percentage of patients reporting long term harm as a result of incorrect advise re exercise.
Are they really prepared to take this risk with patients wellbeing?
 
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I have had a reply to my FOI request which I have endeavoured to upload here. I'll copy it too. My questions are in italic, the replies in quote boxes.
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I am writing to request the following information about the pilot project being run by the Bath Centre for Fatigue Services as part of the West of England Academic Health Sciences Network project called The Future Challenges - Replenish ME. See link below.

1. The research protocol for the pilot project including who is leading it, the ethics committee approval, planned data collection, the planned primary and secondary outcome measures, and method for recording harm.

The Replenish-ME project is being led by the West of England Academic Health Science Network (AHSN), with project partners including the Bath Centre for Fatigue Services (BCFS) at the Royal United Hospitals NHS Trust and KiActiv® . The project is being independently evaluated by the South West Academic Health Science Network.

The project is a real world validation rather than academic research, therefore there is no formal research protocol but the evaluation of the project has been agreed using a Logic Model approach. The project plan and evaluation has been agreed with the whole team and includes the advice and guidance from the Clinical Leads at BCFS to ensure the needs of this patient cohort are comprehensively considered and met. All participants will have the choice to independently self-refer to KiActiv® .

The BCFS team will provide written and verbal information about the project to their patients and it is left to individual patients to contact the company directly if they wish to be part of the project. Ethics committee approval was assessed as not being needed. The project and evaluation plans have been reviewed and endorsed by Dr Tim Craft, Research and Innovation Director RUH, Janes Scott CEO RUH and the Clinical Leads for BCFS.

Data collection will include analysis of anonymised data from the wearable technology, combined with qualitative data collected from participants by KiActiv® and the BCFS staff by the AHSN evaluation team members.

We are aligned with the NICE Guidance for Chronic Fatigue Syndrome/ME [CG53]. In particular we would point to 1.1.1.3 regarding the right of people with CFS/ME to refuse or withdraw from any component of their care and particularly if they feel use of the technology is harmful to them.

There are multiple touchpoints that people will have with both the team at BCFS and their KiActiv mentors to express any concerns they may have, and to record potential harm and individualised support will be employed to address this.

The aim is to provide a more objective and a potentially less burdensome measure of everyday activity, creating personalised understanding to support self-management of their health and wellbeing.
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2. The funding source, amount and breakdown including costs of use of the commercial product and mentors.

The West Of England AHSN is fully funding this project as part of the Future Challenges programme. This programme is funded by the Office of Life Sciences as part of the West of England AHSN commission to
a) Broker real world validation opportunities
b) Support the adoption and spread of promising innovations

The total cost of the programme is £51,897.68. From this sum, £8,139.50 will be paid to KiActiv® to provide the wearable technology, online patient dashboard and mentoring and £4400.00 to BCFS for technology and administration of the project.
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3. Details of the planned training for company mentors to ensure their advice does not run counter to current understanding of the limitations on activity possible for people with ME to prevent harm.

BCFS have provided expert advice as a nationally recognised centre for supporting adults with CFS/ME of some 16 years standing and shared best practice and evidenced based and informed guidelines for the management of CFS/ME with KiActiv and the AHSN and these are all represented within in the project parameters.

The role of the KiActiv® Mentors is to provide empathetic support to users. They are there to guide people through the online dashboard, explaining how to get the most from the technology as a tool for self-management and to answer any questions the user might have. As such, these mentors have been trained in the use of the KiActiv technology, and have undergone specific training and accreditation. The remote sessions are led by the user and KiActiv Mentors do not prescribe improvements to activity, or provide any clinical advice as such. Any deviation from this will be captured in our quality assurance processes and remedied.

We are aligned with the NICE Guidance for Chronic Fatigue Syndrome/ME [CG53]. In particular we would point to 1.1.1.4, which states that the person with CFS/ME is in charge of the aims and goals of the overall management plan. The pace of progression throughout the course of any intervention should be mutually agreed.
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Attachments

Interesting also to see the video describing a similar sounding device called Geneactiv being used for the planned FMT trial in Norwich UK.
https://www.s4me.info/threads/me-public-engagement-event-norwich-feb-2020.13001/#post-241816 though in that case patients will simply wear the device and not get any feedback from it. The researchers will then use it to analyse activity levels as an outcome measure for the trial, rather than as a device to enable patients to monitor their own activity levels.
 
So they have taken on board the possibility that people might experience harm because this community has continued to highlight that.

But now I find this a bit sneaky -- it's not a proper trial but a 'real world validation'. So if people do report harms they are in no way obliged to report that. Is this how others interpret that?
 
I've only skimmed the paper linked in the above post, so not commenting on the use of the device. I was a bit concerned about the implications of one of the questionnaires used in the evaluation. Given that we have a couple of threads on Acceptance and Commitment Therapy I thought it was worth picking up on.

The Bath Centre for Fatigue Services(BCFS), in addition to ME (they call it CFS/ME in the paper), also see people with cancer, joint hypermobility, MS and Parkinsons Disease. The Kiactiv evaluation was only with what they call CFS/ME patients.

BCFS usual service offer includes:

"Fatigue and lifestyle management includes education and skills development in activity pacing and energy usage, gradual reintroduction of lost occupations due to ill health, including employment, management of stress and anxiety and values-based goal setting, using Adaptation Theory, Cognitive Behavioural and Acceptance and Commitment Therapy principles."

Evaluation included this self-report questionnaire:

"Patients were asked to complete a questionnaire at the start and end of the 12-week KiActiv® programme, this included:
● The eight-item Chronic Fatigue Acceptance Questionnaire (CFAQ-8), an adapted version of the eight-item Chronic Pain Acceptance Questionnaire (Fish et al., 2010). The CFAQ-8 includes two subscales:
o Activity engagement – the pursuit of life activities regardless of fatigue
o Fatigue willingness – recognition that avoidance and control are often unworkable methods of adapting to chronic fatigue."


This is the paper for the original scale that the CFAQ-8 was adapted from , but I can't access it.

Fish, R.A., McGuire, B., Hogan, M., Morrison, T.G., & Stewart, I. (2010). Validation of the chronic pain acceptance questionnaire (CPAQ) in an Internet sample and development and preliminary validation of the CPAQ-8. Pain, 149(3), 435-443.
 
Ebb Tide said:
o Activity engagement – the pursuit of life activities regardless of fatigue
o Fatigue willingness – recognition that avoidance and control are often unworkable methods of adapting to chronic fatigue."


This is the paper for the original scale that the CFAQ-8 was adapted from , but I can't access it.

Fish, R.A., McGuire, B., Hogan, M., Morrison, T.G., & Stewart, I. (2010). Validation of the chronic pain acceptance questionnaire (CPAQ) in an Internet sample and development and preliminary validation of the CPAQ-8. Pain, 149(3), 435-443.
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Sicko stuff really isn't it.

How can conversion therapy for certain things be rightly getting outlawed and slated and yet this type of awfulness is sliding in under the radar and being funded by taxpayers and done by people claiming to 'help' or care about physical or mental health.

'avoidance and control' - loaded blinking terms to try and make people just doing what they have to in order to physically survive in situations that shouldn't exist look like unpleasant individuals too imo (and I shouldn't have to use that imo, but yes people are bad and strangely there isn't research into how if you prime someone by telling them an individual is a perfectionist with avoidance and control issues does it make you less likely to be kind/accepting/nice/give the time of day to them just as there isn't one for checking everyone gets wet if they stand unclothed in the rain for an hour)
 
NelliePledge said:
What world do these people live in where naming a questionnaire “acceptance” of a debilitating symptom like pain or chronic fatigue seems appropriate :banghead:
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Especially when what is actually "accepted" is the fact that medicine refuses to take this seriously and put in an adequate effort. Because it's the only reason people have to suffer without any help. It's not because of biology or physiology, it's human folly and ineptitude.

I don't accept that. I will never accept that. These people can be content with their own failure but being the person who is failed in this relationship, I absolutely do not accept other people failing at their job and going through this mediocre ritual that only exists to reward them explicitly for failing.
 
Daisy said:
Full evaluation report is here https://www.weahsn.net/wp-content/uploads/2021/12/The-Future-Challenges-Replenish-ME-FINAL.pdf

Has anyone heard anymore about Kiactiv?
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It's a bit odd how Tommy Parker is described as CEO of Ki Active(R) when there is no company registered under that title - https://www.weahsn.net/2020/10/meet-the-innovator-tommyparker-kiactiv/ and https://kiactiv.com/ Ki Active seemingly is only an internet construct - ownership of the website is obscured on who-is registration searches. The actual ownership of the Ki Activ(R) Trademark* is listed as KI HEALTH INNOVATION LIMITED however the most recently filed accounts show this company to be dormant and it lists no substantial assets. The sole director of the company is Andrew Frederick Parker, and the company address is 1, Duchess Street, London, England, W1W 6AN. Andrew Frederick Parker is also the sole director of Ki Performance Life Style also registered at 1, Duchess Street.

Ki Performance Life Style* filed its year to October 2021 accounts in March 2022 - pdf = https://find-and-update.company-inf...gyNWFkaXF6a2N4/document?format=pdf&download=0 these show intangible assets valued at £1,130,628 intangible would accord with the book value of something such as trade mark.

Other than the name there's no indication of the relationship between Tommy Parker and Andrew Frederick Parker or between kiactive.com and Ki Performance Life Style though licensing of TM products would support financial flows.

UK TM search = https://www.gov.uk/search-for-trademark

Ki Performance Life Style = https://find-and-update.company-information.service.gov.uk/company/06738270/filing-history
 
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