Protocol: Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE), 2015 onwards, Chalder, Moss-Morris, et al

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Protocol Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE) (Chalder, Moss-Morris, etc.)

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https://bmjopen.bmj.com/content/9/7/e025513

Public health
Protocol
Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE)—integrated GP care for persistent physical symptoms: protocol for a feasibility and cluster randomised waiting list, controlled trial
  1. Meenal Patel1,
  2. Kirsty James2,
  3. Rona Moss-Morris3,
  4. Mujtaba Husain4,
  5. Mark Ashworth5,
  6. Philipp Frank1,
  7. Nicola Ferreira1,
  8. Iris Mosweu6,
  9. Paul McCrone6,
  10. Matthew Hotopf1,
  11. Anthony David7,
  12. Sabine Landau2,
  13. Trudie Chalder1
Author affiliations
Abstract
Introduction Persistent physical symptoms (PPS), also known as medically unexplained symptoms are associated with profound physical disability, psychological distress and high healthcare costs. England’s annual National Health Service costs of attempting to diagnose and treat PPS amounts to approximately £3 billion. Current treatment relies on a positive diagnosis, life-style advice and drug therapy. However, many patients continue to suffer from ongoing symptoms and general practitioners (GPs) are challenged to find effective treatments. Training GPs in basic cognitive behavioural skills and providing self-help materials to patients could be useful, but availability in primary care settings is limited.

Methods and analysis A cluster randomised waiting list, controlled trial will be conducted to assess the feasibility of an integrated approach to care in general practice. Approximately 240 patients with PPS will be recruited from 8 to 12 GP practices in London. GP practices will be randomised to ‘integrated GP care plus treatment as usual’ or waiting list control. Integrated GP care plus treatment as usual will include GP training in cognitive behavioural skills, GP supervision and written and audio visual materials for both GPs and participants. The primary objectives will be assessment of trial and intervention feasibility. Secondary objectives will include estimating the intracluster correlation coefficient for potential outcome measures for cluster effects in a sample size calculation. Feasibility parameters and identification of suitable primary and secondary outcomes for future trial evaluations will be assessed prerandomisation and at 12 and 24 weeks’ postrandomisation, using a mixed-methods approach.

Ethics and dissemination Ethical approval was granted by the Camberwell St Giles Ethics Committee. Results will be disseminated via peer-reviewed publications and conference presentations. This trial will inform researchers, clinicians, patients and healthcare providers about the feasibility and potential cost-effectiveness of an integrated approach to managing PPS in primary care.

Trial registration number NCT02444520; Pre-results.
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They were a lot more explicit this time than usual. Disappointing to see the various (non-ME) patient organisations who have given Moss-Morris and Chalder money.
  • Competing interests

    [*]MHotopf reported grants from Innovative Medicines Initiative and European Federation of Pharmaceutical Industries and Associations, outside the submitted work. In addition, TC and RM-M declared the following; organisational financial interests: TC received ad hoc payments for conducting workshops on evidence-based treatments for persistent physical symptoms. TC has received grants from NIHR programme grants, HTA, RfPB, Guy’s and St Thomas Charity, King’s Challenge Fund, Muscular Dystrophy, Multiple Sclerosis Society. King’s College London received payment from Taylor and Francis for editorial role. RM-M currently receives grant funding from NIHR programme grants, Breast Cancer Now, Crohn’s and Colitis UK, and National MS Society. In the previous 36 months, RM-M received funding from MS society UK and NIHR HTA. In 2019, payments from Taylor and Francis to King’s College London for RMM’s role as Editor of Health Psychology Review. Payments for adhoc lectures and workshops on long-term conditions. Personal financial interests: TC is the author of several self-help books on chronic fatigue and received royalties in the past. TC received expenses and ad hoc payment for role as external examiner NUI Galway and Waterford Institute of Technology. TC received expenses for keynote speeches at UK Society for Behavioural Medicine, BABCP Conferences (travel and accommodation). TC received ad hoc payments for conducting workshops on evidence-based treatments for persistent physical symptoms. RM-M received payments for her role as National Advisor to NHS England for Increasing Access to Psychological Therapies (IAPT) for people with long-term conditions from 2011 to 2016. RM-M received ad hoc payments for workshop training in IBS in 2017 and 2018 and this will continue in 2019. RM-M receives ad hoc consultancy payments from Mahana therapeutics and this is likely to continue in 2019. RM-M has stock options in Mahana therapeutics. RM-M received travel expenses for keynote speech to Internal Society of Behavioural Medicine. In 2019, RM-M will be a keynote speaker for Association for Researchers in Psychology and Health (the Netherlands), European Health Psychology Society Annual Conference (Croatia) and the 9th World Congress of Behavioural and Cognitive Therapies (Germany). Travel and accommodation expenses will be reimbursed.
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Introduction
Medically unexplained symptoms (MUS) are an umbrella term referring to persistent bodily symptoms, which cannot be adequately explained by organic pathology.1 MUS are highly prevalent with ~10%–49% of patients in primary care.2 3 MUS are associated with significant functional impairment, psychological distress and high healthcare costs.4–6 Moreover, ~60% of patients have a comorbid psychiatric condition, including depression, anxiety and panic disorders.7–9 The National Health Service (NHS) in England is estimated to spend approximately £3 billion each year attempting to diagnose and treat MUS, which represented ~10% of the total NHS expenditure in 2008–2009.10
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my bolding

@dave30th, is this another case of misuse of the cost statistic? I can't remember if this is one you've tackled already.
 
RM-M
receives ad hoc consultancy payments from Mahana therapeutics and this is likely to continue in 2019. RM-M has stock options in Mahana therapeutics.
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so that's the online CBT sorted then
https://www.mahanatherapeutics.com/

european operation get redirected here https://www.himssanalytics.org/europe/home

company formed in 2018 and MM has stock options...........hmm

a link on the mahana therapeutics home page takes you to this
https://www.mobihealthnews.com/content/depth-defining-burgeoning-field-digital-therapeutics
“We’re on the behavioral side, which definitely gives you a little bit more flexibility than, say, prescribing or diagnosing. If you want to diagnose or treat, especially if it affects medication, the FDA says that that’s where [they] are going to focus their energy initially, people who are trying to diagnose and treat things where there are substantial risks of something going wrong,” Masterson told MobiHealthNews. “I’m excited to see what the FDA does, but it’s crazy. The cost of doing clinical trials and the time to do it are both not very supportive of the technology world, innovation, and what people are willing to spend.”
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Masterson noted that her company’s product is primarily a digital delivery system of an already well-proven behavioral therapy, called Acceptance and Commitment Therapy (ACT). As such, jumping through the same regulatory hoops as a completely new therapeutic is not entirely reasonable for 2Morrow or similar digital products that are on the market, but unregulated.
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“We’re not trying to prove that ACT can be effective for chronic pain — there’s 19 randomized controlled trials published already saying it can, it has strong empirical evidence. But we’re just trying to prove that we can also deliver this approach via the technology,” she said. “To expect people to do five-year randomized controlled trials is not very relevant because the technology will be old by the time the data comes out. If what you’re testing is the technology itself, we have to figure out reasonable ways to quickly assess things.”
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scary
 
The review history is here:
https://bmjopen.bmj.com/content/9/7/e025513.reviewer-comments

These were the reviewers:

Mark A Lumley, Ph.D. Distinguished Professor
Department of Psychology Wayne State University Detroit, Michigan USA

H.E. van der Horst, MD, PhD
Amsterdam University Medical Centers, VUmc, Department of general practice and elderly care medicine The Netherlands.

Keith Geraghty
Centre for Primary Care Division of Population Health, Health Services Research and Primary Care Faculty of Biology, Medicine and Health University of Manchester
 
Tom Kindlon said:
They were a lot more explicit this time than usual. Disappointing to see the various (non-ME) patient organisations who have given Moss-Morris and Chalder money.
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An earlier version of the paper had much fewer conflicts of interest declared. Keith Geraghty challenged them on this:

Conflicts of interests
Sorry authors but you need to have a little bit more respect for the concept of COI declarations. We have this only “TC is the author of several self-help books on chronic fatigue and received royalties in the past. All other authors declare no conflicts of interests.” Firstly, TC can we have more details of your role in any private sector companies, past or present that have promoted CBT? TC could we have details of any national organisations you have been involved with that have promoted CBT? RMM could we have details for your role as IAPTs advisor and NHS advisor promoting CBT in the NHS. Researchers, please list all potential COIs – if you are involved in organisations that promoted the treatment being investigated in this RCT, that is a treatment allegiance that needs to be declared, to patients entering the trial and on all trial documentation, including the published protocol.
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Oh, I'm sure they expected or wanted him to update his COI statement to something like, "hello yes I am delusional and I'm only reviewing this paper to feed my obvious psychosis"
 
I thought this was a shocking comment

Reviewer "1. The original submission, as well as this revision, is written primarily in the future tense. The editors will need to decide whether this verb tense is appropriate for a trial that is in the follow-up stage. I also note that the original submission did not give the study dates, as required, nor does this revised version provide such dates, as far as I can tell. This needs to be corrected, and the editors will need to decide whether this submission meets the journal's criteria for timing."

Comment:
Thank you for your comments. Unfortunately, we would not have been able to change the design of the trial as it was reviewed by external reviewers to obtain the grant and we were somewhat tied. However, we submitted the protocol whilst collecting follow-up data and therefore we meet the journals criteria for timing. As the study was still active when we submitted the manuscript, we feel it is appropriate that it is written in the future tense. We acknowledge that we are late in publishing but on balance thought it was better to have both a protocol and results paper to have the space to fully describe the process and results. Following BMJ open guidelines, we have included details regarding trial registration at the end of the abstract. As requested, we will include the start of the study date.
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What they are basically admitting to is very late publication (and possibly design) of the protocol duing the collection of follow up data but making it seem like it was submitted prior to the trial starting. They claim that external reviews looked at it prior to the grant but this won't cover any protocol changes made subsequently.
 
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