Behavioural modification interventions for medically unexplained symptoms in primary care: systematic reviews & economic evaluation, 2020, White et al

Sly Saint

Senior Member (Voting Rights)
Have set this up on a thread on it's own (was previously on https://www.s4me.info/threads/mus-services-in-uk-and-other-mus-related-issues.8318/ )
University of Sheffield.
Funding details:
Funding:
National Institute of Health Research (NIHR) Health Technology Assessment (HTA) Programme (evidence synthesis)

Call: 14/26 Medically unexplained symptoms (MUS): primary care intervention

Start date: 01/09/2015 End date: 28/02/2017 (18 months)

Total Research costs: £200,007.67

Chief Investigator: Dr Joanna Leaviss

Organisation: ScHARR, University of Sheffield

https://www.sheffield.ac.uk/scharr/sections/heds/mus/info

https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=25520

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&cad=rja&uact=8&ved=2ahUKEwjd4KPU-dTgAhU6VxUIHW8pBp4QFjADegQIBhAC&url=https://njl-admin.nihr.ac.uk/document/download/2007338&usg=AOvVaw03jEe_b-20sZFMPNGgEu3A

Doing a bit more digging on this systematic review done at Sheffield.
Coyne wrote a detailed blog about it in 2016
https://jcoynester.wordpress.com/20...rventions-for-medically-unexplained-symptoms/

it ends with this line
"Consumers and taxpayers are put at risk from biased evaluations of interventions which will undoubtedly affect health policy decisions."

It was discussed on PR (before my time)
https://forums.phoenixrising.me/threads/£208-000-of-taxpayers-money-for-a-group-incl-peter-white-rona-moss-morris-to-review-mus-evidence.39746/

I wrote to Joanna Leavis to ask a few questions.
It was treated as an FOI and had this reply:

I write in response to your request for information to Dr Joanna Leavis. As you are no doubt aware, all requests for information made to Public Authorities as defined in the Freedom of Information Act should be regarded as being made under the requirements of that Act, and so your request has been passed to me.
The University's responses to your questions follow:
RE:
14/26 Medically unexplained symptoms (MUS): primary care intervention: please could you tell me if this review has finished


(according to protocol it finished in 2017 but PROSPERO says the review is ongoing).
This study is on-going.

Have the results been published? If so, where.
No, but they will be published as an HTA monograph in due course

Could you also tell me which charities were represented in the Expert advisory group?.
This information will be included in the published study and is therefore exempt from disclosure at the current time under Section 22 of the Freedom of Information Act (information intended for future publication)..

I am required under the Act to inform you that if you have cause for genuine complaint regarding our reply to your request for information, you should within 60 days of receiving this response, write to the University FOI Unit, The University Secretary’s Office, Sheffield University, Western Bank, Sheffield S10 2TN or email foi@sheffield.ac.uk explaining why you are not satisfied with the result.

If you still remain unsatisfied with the University's decision, you will be entitled to complain to the Information Commissioner, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.


Yours sincerely


Anne Cutler

The University Secretary’s Office

University of Sheffield

Western Bank

Sheffield

S10 2TN

estimated publication date of this study is now Nov 2019
 
Latest project information
Medically unexplained symptoms(MUS): primary care intervention
Project title: Medically unexplained symptoms(MUS): primary care intervention

Call to action: 14/26 14/26 Medically unexplained symptoms (MUS): primary care intervention

Research type: Evidence Synthesis

Chief investigator: Dr Joanna Leavissorcid.org/0000-0002-5632-6021

Contractor: The University of Sheffield

Cost: £212,436.22

Co-investigators: Dr Alison Scope, Dr Andrew Booth, Dr Marta Buszewicz, Dr Shijie Ren, Ms Andrea Shippam, Ms Anthea Sutton, Ms Sarah Davis, Professor Glenys Parry, Professor Matt Stevenson, Professor Peter White, Professor Rona Moss-Morris.

Started: September 2015 | Status: Waiting to publish

PROSPERO registration: CRD42015025520
https://www.journalslibrary.nihr.ac.uk/programmes/hta/142608/#/

https://www.journalslibrary.nihr.ac.uk/search/#/?search=14/26 Medically unexplained symptoms (MUS)* primary care intervention&sitekit=true&indexname=full-index&task=search&selected_facets=

Health Technology Assessment Estimated Publication Date: Mar 2020

eta: original publication was due in 2017(?) why the massive delay? and new publication date very close to ME NICE guidelines publication.

@dave30th

anyone in contact with Coyne, and Keith Geraghty.
 
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Latest project information

https://www.journalslibrary.nihr.ac.uk/programmes/hta/142608/#/

https://www.journalslibrary.nihr.ac.uk/search/#/?search=14/26 Medically unexplained symptoms (MUS)* primary care intervention&sitekit=true&indexname=full-index&task=search&selected_facets=

Health Technology Assessment Estimated Publication Date: Mar 2020

eta: original publication was due in 2017(?) why the massive delay? and new publication date very close to ME NICE guidelines publication.

Maybe they wanted to see how things shook out with Larun, the HRA, etc? Maybe they now feel they have cover for ignoring the problems with this research? Or I guess sometimes things just get delayed?

I does look like a ridiculous piece of research if they're just interested in how to manipulate the way people fill in QoL questionnaires.
 
Abstract
The term MUS is used to cover a wide range of symptoms which cannot clearly be explained by a general medical condition, even after a thorough examination and any relevant investigations.

A UK MUS prevalence rate of 18% of consecutive attenders to UK GP practices has been estimated (Taylor et al 2012).

MUS costs the UK NHS in excess of £3.1 billion per annum and taking into account quality of life and sickness absence, wider costs to the economy reach £14 billion annually (Bermingham et al. 2010).

A range of pharmacological, psychological and physical therapies have been implemented in the treatment of MUS. Behavioural Modification Interventions such as Cognitive Behavioural Therapy (CBT), Graded Exercise Therapy (GET), and behaviour therapies are commonly delivered in primary care.

We will conduct a systematic review, using rigorous methods, of the evidence on the clinical, cost-effectiveness and acceptability of behavioural modification interventions for MUS in primary care and community-based settings.

Search strategy: we will conduct a comprehensive search of bibliographic databases, combining terms for MUS and related synonyms and primary care setting. Searches will not be limited by intervention as we anticipate overlap between interventions and inconsistencies in labels and definitions.

Methodological search filters will be applied to identify systematic reviews, RCTs, and qualitative research and cost-effectiveness where appropriate. Inclusion criteria: Intervention interventions that aim to modify behaviour will be included. These include CBT, GET, behaviour therapies.

Where the intervention is not explicitly behaviour modification, we will adopt a broad inclusion criteria, with studies included if i) at least one primary outcome is a functional or behavioural change measure, or ii) the stated explicit aim of the intervention is to change behaviour. Population studies of populations meeting the criteria for MUS, MUPS, or somatoform disorders. Functional somatic syndromes will be included. Setting studies in primary care or community-based settings.

Design Randomised Controlled Trials. Comparator usual care, treatment as usual, or wait list, trials with a placebo control. We will also include head to head trials. Outcomes improvement in symptoms, functioning and/or health related quality of life; use of healthcare resources.

Quantitative synthesis: a random effects network meta-analysis will be used, providing the relevant RCTs form a network of evidence. The random effects pairwise comparison will allow heterogeneity in treatment effects across studies. Random effects pairwise meta-analysis will be performed when data do not form a network.

Qualitative synthesis: A realist synthesis will be conducted to provide added value to the quantitative synthesis by indicating patient and service provider issues around the acceptability of interventions. Thematic synthesis will be used to aggregate the findings.

Cost-effectiveness: evidence on cost-effectiveness will be identified by conducting a systematic review of existing economic analyses, and undertaking a de novo model based evaluation where there is a lack of relevant existing analyses. Costs will be evaluated from an NHS and personal social services perspective.

Health benefits will be estimated using quality-adjusted life years (QALYS) gained. Future costs will be discounted at 3.5% in line with NICE's current guidance.

@dave30th
could you take a look at/chase this up
 
Merged thread

Behavioural modification interventions for medically unexplained symptoms in primary care: systematic reviews & economic evaluation, 2020, White et al


Background
The term ‘medically unexplained symptoms’ is used to cover a wide range of persistent bodily complaints for which adequate examination and appropriate investigations do not reveal sufficiently explanatory structural or other specified pathologies. A wide range of interventions may be delivered to patients presenting with medically unexplained symptoms in primary care. Many of these therapies aim to change the behaviours of the individual who may have worsening symptoms.

Objectives
An evidence synthesis to determine the clinical effectiveness and cost-effectiveness of behavioural modification interventions for medically unexplained symptoms delivered in primary care settings was undertaken. Barriers to and facilitators of the effectiveness and acceptability of these interventions from the perspective of patients and service providers were evaluated through qualitative review and realist synthesis.

Data sources
Full search strategies were developed to identify relevant literature. Eleven electronic sources were searched. Eligibility criteria – for the review of clinical effectiveness, randomised controlled trials were sought. For the qualitative review, UK studies of any design were included. For the cost-effectiveness review, papers were restricted to UK studies reporting outcomes as quality-adjusted life-year gains. Clinical searches were conducted in November 2015 and December 2015, qualitative searches were conducted in July 2016 and economic searches were conducted in August 2016. The databases searched included MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO and EMBASE. Updated searches were conducted in February 2019 and March 2019.

Participants
Adult participants meeting the criteria for medically unexplained symptoms, including somatoform disorders, chronic unexplained pain and functional somatic syndromes.

Interventions
Behavioural interventions were categorised into types. These included psychotherapies, exercise-based interventions, multimodal therapies (consisting of more than one intervention type), relaxation/stretching/social support/emotional support, guided self-help and general practitioner interventions, such as reattribution. Evidence synthesis: a network meta-analysis was conducted to allow a simultaneous comparison of all evaluated interventions in a single coherent analysis. Separate network meta-analyses were performed at three time points: end of treatment, short-term follow-up (< 6 months since the end of treatment) and long-term follow-up (≥ 6 months after the end of treatment). Outcomes included physical and psychological symptoms, physical functioning and impact of the illness on daily activities. Economic evaluation: within-trial estimates of cost-effectiveness were generated for the subset of studies where utility values (or quality-adjusted life-years) were reported or where these could be estimated by mapping from Short Form questionnaire-36 items or Short Form questionnaire-12 items outcomes.

Results
Fifty-nine studies involving 9077 patients were included in the clinical effectiveness review. There was a large degree of heterogeneity both between and within intervention types, and the networks were sparse across all outcomes. At the end of treatment, behavioural interventions showed some beneficial effects when compared with usual care, in particular for improvement of specific physical symptoms [(1) pain: high-intensity cognitive–behavioural therapy (CBTHI) standardised mean difference (SMD) 0.54 [95% credible interval (CrI) 0.28 to 0.84], multimodal SMD 0.52 (95% CrI 0.19 to 0.89); and (2) fatigue: low-intensity cognitive–behavioural therapy (CBTLI) SMD 0.72 (95% CrI 0.27 to 1.21), relaxation/stretching/social support/emotional support SMD 0.87 (95% CrI 0.20 to 1.55), graded activity SMD 0.51 (95% CrI 0.14 to 0.93), multimodal SMD 0.52 (95% CrI 0.14 to 0.92)] and psychological outcomes [(1) anxiety CBTHI SMD 0.52 (95% CrI 0.06 to 0.96); (2) depression CBTHI SMD 0.80 (95% CrI 0.26 to 1.38); and (3) emotional distress other psychotherapy SMD 0.58 (95% CrI 0.05 to 1.13), relaxation/stretching/social support/emotional support SMD 0.66 (95% CrI 0.18 to 1.28) and sport/exercise SMD 0.49 (95% CrI 0.03 to 1.01)]. At short-term follow-up, behavioural interventions showed some beneficial effects for specific physical symptoms [(1) pain: CBTHI SMD 0.73 (95% CrI 0.10 to 1.39); (2) fatigue: CBTLI SMD 0.62 (95% CrI 0.11 to 1.14), relaxation/stretching/social support/emotional support SMD 0.51 (95% CrI 0.06 to 1.00)] and psychological outcomes [(1) anxiety: CBTHI SMD 0.74 (95% CrI 0.14 to 1.34); (2) depression: CBTHI SMD 0.93 (95% CrI 0.37 to 1.52); and (3) emotional distress: relaxation/stretching/social support/emotional support SMD 0.82 (95% CrI 0.02 to 1.65), multimodal SMD 0.43 (95% CrI 0.04 to 0.91)]. For physical functioning, only multimodal therapy showed beneficial effects: end-of-treatment SMD 0.33 (95% CrI 0.09 to 0.59); and short-term follow-up SMD 0.78 (95% CrI 0.23 to 1.40). For impact on daily activities, CBTHI was the only behavioural intervention to show beneficial effects [end-of-treatment SMD 1.30 (95% CrI 0.59 to 2.00); and short-term follow-up SMD 2.25 (95% CrI 1.34 to 3.16)]. Few effects remained at long-term follow-up. General practitioner interventions showed no significant beneficial effects for any outcome. No intervention group showed conclusive beneficial effects for measures of symptom load (somatisation). A large degree of heterogeneity was found across individual studies in the assessment of cost-effectiveness. Several studies suggested that the interventions produce fewer quality-adjusted life-years than usual care. For those interventions that generated quality-adjusted life-year gains, the mid-point incremental cost-effectiveness ratios (ICERs) ranged from £1397 to £129,267, but, where the mid-point ICER fell below £30,000, the exploratory assessment of uncertainty suggested that it may be above £30,000.

Limitations
Sparse networks meant that it was not possible to conduct a metaregression to explain between-study differences in effects. Results were not consistent within intervention type, and there were considerable differences in characteristics between studies of the same type. There were moderate to high levels of statistical heterogeneity. Separate analyses were conducted for three time points and, therefore, analyses are not repeated-measures analyses and do not account for correlations between time points.

Conclusions
Behavioural interventions showed some beneficial effects for specific medically unexplained symptoms, but no one behavioural intervention was effective across all medically unexplained symptoms. There was little evidence that these interventions are effective for measures of symptom load (somatisation). General practitioner-led interventions were not shown to be effective. Considerable heterogeneity in interventions, populations and sparse networks mean that results should be interpreted with caution. The relationship between patient and service provider is perceived to play a key role in facilitating a successful intervention. Future research should focus on testing the therapeutic effects of the general practitioner–patient relationship within trials of behavioural interventions, and explaining the observed between-study differences in effects within the same intervention type (e.g. with more detailed reporting of defined mechanisms of the interventions under study).
Open access, https://www.journalslibrary.nihr.ac.uk/hta/hta24460#/full-report

 
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Declared competing interests of authors: Rona Moss-Morris has published papers that met the criteria for inclusion in the review, and she was previously an advisor to the NHS Improving Access to Psychological Therapies programme. Peter White does consultancy work for a re-insurance company. He also is a member of the Independent Medical Experts Group, a non-departmental body, which advises the UK Ministry of Defence regarding the Armed Forces Compensation Fund. Peter White was also an unpaid chairperson of One Health between 2002 and 2010. One Health is a not-for-profit company that was set up to promote the British Psychological Society model within medicine.
Andrew Booth is a member of the National Institute for Health Research (NIHR) Complex Reviews Advisory Board, the NIHR Health Services and Delivery Research Funding Board and the NIHR Systematic Review Advisory Group.
Peter White is still not making clear he is or was a chief medical officer of a re-insurance company. It still sounds like he is no different to a bigger group of doctors who do the odd paid assessment for insurance companies.

I think it should have been “biopsychosocial model” not “British Psychology Society model”
 
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About the journal Health Technology Assessment:

HTA publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
https://www.journalslibrary.nihr.ac.uk/hta/about-the-hta-journal.htm

From the paper:
Behavioural interventions were categorised into types. These included psychotherapies, exercise-based interventions, multimodal therapies (consisting of more than one intervention type), relaxation/stretching/social support/emotional support, guided self-help and general practitioner interventions, such as reattribution

Didn't know that these interventions are "health technology".

So much to learn!

Peter White declaring some of his competing interests said:
One Health is a not-for-profit company that was set up to promote the British Psychological Society model within medicine.

I think it should have been “biopsychosocial model” not “British Psychology Society model”
:rofl:
 
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This is a wild grab bag of various unrelated things. Even an apples to oranges comparison doesn't give it justice. How is such a trivial evaluation worth being published? It basically amounts to a global evaluation of alternative medicine, all types considered. Other than the underlying assumptions of a still-to-be-shown psychosomatic component, there is nothing linking those interventions.

Nevertheless it features all the same: no evidence, but let's keep doing it because we believe in it. Remove the belief and no one would argue this is worth even attempting, let alone continuing after decades and still no evidence of efficacy. Meanwhile the opportunity cost of this nonsense has been decades of stagnation because serious research is held up, with millions of lives sacrificed to an insane ideology.

An economic evaluation of QALY cost-effectiveness is absurd, it literally only counts imagined gains while discounting the enormous costs of failure of this ideology, which leaves tens of millions disabled without support. The economic losses of this approach are massively negative and that this actually passed peer review shows that there is basically no peer review in this field, it is entirely on style and fully ignores the substance of what is in the papers. Any claim can be made, nothing has to be provided to back them.
The relationship between patient and service provider is perceived to play a key role in facilitating a successful intervention
There is no relationship. You broke it on purpose to suit your selfish wants. There is explicitly no such relationship with the likes of you, meanwhile there literally is no relationship with clinicians because we are discriminated out of medical care because of this delusional fantasy of yours. Even worse, there are no actual specialists for this because the entire field has been held up for decades, so no relationship there either.
 
Finally, I just received notification that this has been published:

Behavioural modification interventions for medically unexplained symptoms in primary care: systematic reviews and economic evaluation
Abstract
Background
The term ‘medically unexplained symptoms’ is used to cover a wide range of persistent bodily complaints for which adequate examination and appropriate investigations do not reveal sufficiently explanatory structural or other specified pathologies. A wide range of interventions may be delivered to patients presenting with medically unexplained symptoms in primary care. Many of these therapies aim to change the behaviours of the individual who may have worsening symptoms.

Objectives
An evidence synthesis to determine the clinical effectiveness and cost-effectiveness of behavioural modification interventions for medically unexplained symptoms delivered in primary care settings was undertaken. Barriers to and facilitators of the effectiveness and acceptability of these interventions from the perspective of patients and service providers were evaluated through qualitative review and realist synthesis.

Data sources
Full search strategies were developed to identify relevant literature. Eleven electronic sources were searched. Eligibility criteria – for the review of clinical effectiveness, randomised controlled trials were sought. For the qualitative review, UK studies of any design were included. For the cost-effectiveness review, papers were restricted to UK studies reporting outcomes as quality-adjusted life-year gains. Clinical searches were conducted in November 2015 and December 2015, qualitative searches were conducted in July 2016 and economic searches were conducted in August 2016. The databases searched included MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO and EMBASE. Updated searches were conducted in February 2019 and March 2019.

Participants
Adult participants meeting the criteria for medically unexplained symptoms, including somatoform disorders, chronic unexplained pain and functional somatic syndromes.

Interventions
Behavioural interventions were categorised into types. These included psychotherapies, exercise-based interventions, multimodal therapies (consisting of more than one intervention type), relaxation/stretching/social support/emotional support, guided self-help and general practitioner interventions, such as reattribution. Evidence synthesis: a network meta-analysis was conducted to allow a simultaneous comparison of all evaluated interventions in a single coherent analysis. Separate network meta-analyses were performed at three time points: end of treatment, short-term follow-up (< 6 months since the end of treatment) and long-term follow-up (≥ 6 months after the end of treatment). Outcomes included physical and psychological symptoms, physical functioning and impact of the illness on daily activities. Economic evaluation: within-trial estimates of cost-effectiveness were generated for the subset of studies where utility values (or quality-adjusted life-years) were reported or where these could be estimated by mapping from Short Form questionnaire-36 items or Short Form questionnaire-12 items outcomes.

Results
Fifty-nine studies involving 9077 patients were included in the clinical effectiveness review. There was a large degree of heterogeneity both between and within intervention types, and the networks were sparse across all outcomes. At the end of treatment, behavioural interventions showed some beneficial effects when compared with usual care, in particular for improvement of specific physical symptoms [(1) pain: high-intensity cognitive–behavioural therapy (CBTHI) standardised mean difference (SMD) 0.54 [95% credible interval (CrI) 0.28 to 0.84], multimodal SMD 0.52 (95% CrI 0.19 to 0.89); and (2) fatigue: low-intensity cognitive–behavioural therapy (CBTLI) SMD 0.72 (95% CrI 0.27 to 1.21), relaxation/stretching/social support/emotional support SMD 0.87 (95% CrI 0.20 to 1.55), graded activity SMD 0.51 (95% CrI 0.14 to 0.93), multimodal SMD 0.52 (95% CrI 0.14 to 0.92)] and psychological outcomes [(1) anxiety CBTHI SMD 0.52 (95% CrI 0.06 to 0.96); (2) depression CBTHI SMD 0.80 (95% CrI 0.26 to 1.38); and (3) emotional distress other psychotherapy SMD 0.58 (95% CrI 0.05 to 1.13), relaxation/stretching/social support/emotional support SMD 0.66 (95% CrI 0.18 to 1.28) and sport/exercise SMD 0.49 (95% CrI 0.03 to 1.01)]. At short-term follow-up, behavioural interventions showed some beneficial effects for specific physical symptoms [(1) pain: CBTHI SMD 0.73 (95% CrI 0.10 to 1.39); (2) fatigue: CBTLI SMD 0.62 (95% CrI 0.11 to 1.14), relaxation/stretching/social support/emotional support SMD 0.51 (95% CrI 0.06 to 1.00)] and psychological outcomes [(1) anxiety: CBTHI SMD 0.74 (95% CrI 0.14 to 1.34); (2) depression: CBTHI SMD 0.93 (95% CrI 0.37 to 1.52); and (3) emotional distress: relaxation/stretching/social support/emotional support SMD 0.82 (95% CrI 0.02 to 1.65), multimodal SMD 0.43 (95% CrI 0.04 to 0.91)]. For physical functioning, only multimodal therapy showed beneficial effects: end-of-treatment SMD 0.33 (95% CrI 0.09 to 0.59); and short-term follow-up SMD 0.78 (95% CrI 0.23 to 1.40). For impact on daily activities, CBTHI was the only behavioural intervention to show beneficial effects [end-of-treatment SMD 1.30 (95% CrI 0.59 to 2.00); and short-term follow-up SMD 2.25 (95% CrI 1.34 to 3.16)]. Few effects remained at long-term follow-up. General practitioner interventions showed no significant beneficial effects for any outcome. No intervention group showed conclusive beneficial effects for measures of symptom load (somatisation). A large degree of heterogeneity was found across individual studies in the assessment of cost-effectiveness. Several studies suggested that the interventions produce fewer quality-adjusted life-years than usual care. For those interventions that generated quality-adjusted life-year gains, the mid-point incremental cost-effectiveness ratios (ICERs) ranged from £1397 to £129,267, but, where the mid-point ICER fell below £30,000, the exploratory assessment of uncertainty suggested that it may be above £30,000.

Limitations
Sparse networks meant that it was not possible to conduct a metaregression to explain between-study differences in effects. Results were not consistent within intervention type, and there were considerable differences in characteristics between studies of the same type. There were moderate to high levels of statistical heterogeneity. Separate analyses were conducted for three time points and, therefore, analyses are not repeated-measures analyses and do not account for correlations between time points.
Conclusions
Behavioural interventions showed some beneficial effects for specific medically unexplained symptoms, but no one behavioural intervention was effective across all medically unexplained symptoms. There was little evidence that these interventions are effective for measures of symptom load (somatisation). General practitioner-led interventions were not shown to be effective. Considerable heterogeneity in interventions, populations and sparse networks mean that results should be interpreted with caution. The relationship between patient and service provider is perceived to play a key role in facilitating a successful intervention. Future research should focus on testing the therapeutic effects of the general practitioner–patient relationship within trials of behavioural interventions, and explaining the observed between-study differences in effects within the same intervention type (e.g. with more detailed reporting of defined mechanisms of the interventions under study).
https://www.journalslibrary.nihr.ac.uk/hta/hta24460/#/abstract

what an utter waste of money
 
I wrote to Joanna Leavis to ask a few questions.
It was treated as an FOI and had this reply:

...
Could you also tell me which charities were represented in the Expert advisory group?.
This information will be included in the published study and is therefore exempt from disclosure at the current time under Section 22 of the Freedom of Information Act (information intended for future publication)...

estimated publication date of this study is now Nov 2019

The only bit I could see on charity/patient involvement was this, and I couldn't see any information on how these patients were chosen:

Patients were involved throughout the review process. Two members of the public with a history of MUS contributed to the writing of the review protocol. They, along with a person with experience of fibromyalgia, went on to be active members of our Expert Advisory Group. The Expert Advisory Group was made up of subject experts, clinicians and our patient and public involvement (PPI) representatives(experts by experience). There were two whole-group meetings: the project team and one of the Expert Advisory Group, held at the School of Health and Related Research (ScHARR) but with an independent chairperson. These were at the beginning of the review to discuss plans and potential issues before the review got started, and at the end of the review to report the results of the review. Between these meetings, the Expert Advisory Group were e-mailed at key stages in the project to receive updates onprogress and to be invited to contribute any feedback.

In addition to the two whole-group meetings, a meeting with JL, AS and MB was held in London solely for the PPI representatives. The purpose of this meeting was to allow a more informal discussion of the project, in particular the qualitative and quantitative reviews, with a focus on a patient point of view.The PPI representatives were also given a booklet containing plain English information on the systematic review process.All of the PPI representatives made substantial and valuable contributions to the project. Providing a patient perspective at each stage of the review enabled the project team to gain a deeper understanding of the issues arising from the literature, and kept the importance of patient perceptions of their symptoms and health-care provision in focus.

One patient with MUS wrote:

Being involved with this review has opened up my understanding of how important it is when one has ‘unexplained symptoms’ to take part in one’s own recovery and health and how difficult it must befor doctors to have patients who look to them as saviours, not to be able to diagnose and then treat. I thoroughly enjoyed having an insight into both doctors’ and patients’ point of view into the frustrating world of MUS! It also gave me hope seeing the differing and varied interventions available. It was encouraging to see that nearly all symptoms under the various headings seemed to respond to CBT.It has been a great pleasure to be involved with this study and review. The team were brilliant in making a very complex subject accessible and interesting to a lay person.​

The other patient with MUS wrote:

It has been a fascinating experience being a small part of a very carefully thought out and thorough review. Credit should go to the team that managed to filter through all of the studies and create a model that allowed for some conclusions to be made. While the review didn’t perhaps reach the clear conclusions it aimed for, there were a lot of interesting observations: From a patient-perspective, the fact that there were few significant effects for any GP intervention, i.e. reattribution, GP led CBT, or GP MUS management, is quite worrying. It is useful knowledge that multimodal and CBT interventions have an impact on the majority of MUS. These findings are something that should be embraced and addressed by the NHS (although it’s interesting to see that there is little evidence supporting the impact on long-term health). It seems that patient caution and stigma can still be attached to CBT and similar therapies so I would be interested to find how this problem could be tackled in the future. It’s also a pity that little could be found that would benefit patients with ‘somatisation and generic physical symptoms’. I’ve really enjoyed working on this project and would be happy to contribute to any further studies.​

The person with experience of fibromyalgia wrote:

My experience of being part of the stakeholder group: It was an enormous piece of research that was undertaken and I observed that it was done with great care. I always felt that my opinions, written and oral, were taken seriously and followed-up. I am not sure how valuable my contributions were. I do know that I tried my best to look at all the information and paid attention to the details as much as I tried to look at the bigger picture. I do think that having patient representatives helps to keep the research grounded in the real world. I was astounded by some of the outcomes, as they seemed counter to generally held beliefs. This only shows how important it was to collate this evidence. I do hope that the report will help many people with pain and other unexplained symptoms to reach relief that they have not yet achieve​

Three experts by experience also contributed to all stages of the project and were members of the Expert Advisory Group, and Professor Chris Burton, ScHARR, University of Sheffield, for his comments on the realist review.
 
I'm not reading this review properly, but just searched for 'Leone' as I wondered if they'd included this null result (I have a suspicious mind): https://www.sciencedirect.com/science/article/abs/pii/S0022399906002273

They say:

a Leone et al.155A 4-year follow-up is summarised in the narrative section only as 4 years was substantially longer than any other follow-up period.

Though to be fair, they do seem to include the earlier null results from that trial (I've not looked at the details):

Huibers, 2004/Leone, 2006153,155

Chronic fatigue GP-CBT vs. UC CIS–Fatigue Severity Subscale

No significant difference between CBT and usual-care groups at any point including 4 years’ follow-up

I'm not sure how fair their decision was, but it was a little odd that the first null result I decided to check for was excluded like that.
 
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They make some reference to the Crawley/O'Dowd trial that I think @JohnTheJack was trying to get data for. I'm only quickly looking through this, and I think that maybe they just referenced it in a section on more recent trials.

All data from O’Dowd373,374are taken from the protocol registered on the ISRCTN trial registry, with outcome data retrieved from an additional file uploaded to the registry on 27 March 2019. Data we reaccessed on 2 May 2019. Further information was obtained from a previous freedom of information request published in 2016

373. O’Dowd H.ISRCTN Registry. URL:https://doi.org/10.1186/ISRCTN72645894(accessed2 May 2019).374. O’Dowd H.WhatdotheyKnow.com. Results for Trial ID ISRCTN72645894. 2016. URL:www.whatdotheyknow.com/request/results_for_trial_id_isrctn72645(accessed 3 May 2019).

Too tired to read more right now.
 
The only bit I could see on charity/patient involvement was this, and I couldn't see any information on how these patients were chosen:

Those patient comments are very weird, they read insincere, almost fake. Whether real or not, they do not reflect typical patients, at best just tokenism participation. Not to be conspiratorial, it wouldn't even be the worst thing these people have done anyway, but there is a weird quality to fake comments, like on fake product testimonials that read like material straight of the marketing department. And these comments reek of that. Best case they selected people who would say yes to anything and were just happy to be involved. That's not what patient involvement is about, especially with people who operate entirely within a closed circle jerk where no conflicting opinion is allowed.

Tokenism is worse than no patient involvement. It shows blatant disrespect for the very reasons patient involvement is critical moving forward.
 
they selected people who would say yes to anything and were just happy to be involved.

There are some things about the comments that worry me, and it seems like they may have selected the sorts of patients more likely to tell them what they want to hear, but if they're just individual patients (rather than those part of an organisation) then I think that we should avoid being critical of them.
 
hose patient comments are very weird, they read insincere, almost fake. Whether real or not, they do not reflect typical patients, at best just tokenism participation.
I don't blame the patients involved. The blame lies squarely with the researchers for not trianing the patient reps properly in what to look for and what makes good science.

If you're not aware that subjective outcomes in open label trials are valueless, problems with therapist effect etc, you might reasonably assume the research is valid.

If you are unaware that the researchers doing the systematic review are some of the worst perpetrators of bad science, and you don't have sufficient background knowledge to know what good clinical trial evidence should look like, how can you be objective?
 
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