Patient Consent · @consent_patient
28th Sep 2018 from TwitLonger
NICE CFS/ME Guidelines Methodology , summery and Evidence Based Medicine ?
NICE CFS/ME Guidelines Methodology , summery and Evidence Based Medicine
Alongside the reform of the “NHS”, NICE is recently undergoing many changes
NICE ensures alignment with the whole system .They also have a new framework agreement outlining their working relationship with the department of health and social care . As the DOH has had a name change , so has NICE , to account for the added role to develop care standards for social care . NICE has also incorporated the prescribing center , and is updating its guideline development manual.
NICE is advocated as making evidence based recommendations , and so GPs , paediatricians and other users assume there to be an evaluated evidence bace behind the recommendations which have been made in guidelines .
In the case of the commissioned development of the CFS/ME guidelines 2007 , there was not much research evidence at that time on interventions . Therefore NICE decided to use a consensus methodology to make recommendations . This was called Delphi consensus methodology , which was not part of NICE ordinary development process . It was piloted in the development of the CFS/ME 2007 guideline development .
The consensus method was used to support the Guideline Development Group in reaching their opinions . Yet , the Delphi consensus methodology also included 20% random selection of areas the GDG could find consensus on . ( appendix 6 E , from the published info on Delphi ) Those who were given the questionnaire , were also given the guidelines development groups ratings . How the method controlled for bias is thus unclear .
Clinical scenarios were created and voted on , which included the issuing of a questionnaire to all registered stakeholders , although the identity and organisation of those who returned the questionnaire is not clear , or if they were required to declare COI . Important considering they were involved in making recommendations , via consensus methodology . Results of the questionnaires and the clinical scenarios can be seen in appendix 3 of the full version of the guidelines .
This meant that in some areas recommendations were based on opinion , not evidence , where there was none . The guideline development group chair Richard Baker , and reviewer E J Shaw , wrote a summary of the guideline in 2007 ,highlighting areas were recommendations were based on consensus opinion . These areas were indicated with an asterisk . https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1962830/
Areas include , the management of Post Exertional Malaise or Post Exertional neuroimmune exhaustion , which is the term used in the International Consensus Criteria for ME , which mentions PEM/PENE as the hallmark symptom that differentiates ME from other fatiguing illnesses , with objectively proven evidence of abnormal physiological response to exertion and aerobic exercise , also referred to in the NICE guidelines and by clinics as a setback .
Additional areas highlighted , where recommendations for patient management was based on consensus rather then evidence include , sleep management and restriction of rest . ( Please read the Baker and Shaw summery for other areas indicated where the guideline statements used consensus not evidence, as there are many.)
However , the summary excluded that recommendations for children regarding GET was based on consensus opinion , as there was no evidence for GET for children . There currently still is no evidence for GET for children . Magenta is the first trial currently being conducted to study GET on children , and yet to be completed and published . There is no evidence for its effectiveness or cost effectiveness for children .
Another area which was not highlighted by Baker and Shaws summary ,where recommendations were make via consensus and lack of evidence , include recommendations for the sever , where NICE Guidelines recommends incorporating versions of CBT, GET or Activity Management .
“There was both a lack of evidence and no consensus about whether GET is appropriate for people, in particular children, with severe CFS/ME. Therefore the GDG did not recommend GET for people with severe CFS/ME but elements of it may be appropriate.”
“1.9.3.1 People with severe CFS/ME should be offered an individually tailored activity management programme (see recommendation 1.6.2.22) as the core therapeutic strategy, which may:
• be delivered at home, or using telephone or email if appropriate
• incorporate the elements of recommendation 1.6.2.22 and draw on the principles of CBT and GET (see recommendations 1.6.2.1–21).
1.9.3.2 An activity management programme should be reviewed regularly and frequently “
However , the intervention called Activity Management (all activity types , including exercise, with planned increases in activity ) , was also mentioned in the full version of the guideline, as having no evidence bace at all .
“The GDG found it difficult to find a precise definition for activity management and therefore to find evidence for its effectiveness. As it is based on similar principles and goals to graded exercise therapy the GDG made consensus recommendations regarding activity management .” Pg 252
Activity Management (all activity and aerobic exercise as described in the the NICE Guidelines, though just increasing cognitive activity only to eight hours a day in the FITNET study , and focus on school work and no exercise in the Magenta study ) , is being used as a comparator in both Fitnet (due in 2019) , and Magenta “Pace Trial For Kids”,
Magenta compares Activity Management with GET , which uses aerobic exercise, with increasing intensity when reading 30min a day, and due in 2022 . Fitnet is a family focussed therapy as parents are receive psycho education according to the CBT model and Biospychosocial explanation for symptoms , where specialist CBT is delivered via digital technology , and designed to increase activity , and school attendance , and is due in 2019. Which has received complaint regarding informed consent to the ethics team , which was not upheld .
NICE research recommendations highlighted that these two patient groups (children and sever , ) , have limited evidence of benefit , and some finding these interventions harmful . There is limited number of CBT studies for children only. Yet , this was not highlighted in the summary by Baker and Shaw.
Severity levels are defined in NICE terminology section , and studies provide definitions for severity levels , and interventions used. In the Pace Trial, which has been reanalysed and found to have overstated its results , sever , who were not studied , were defined as housebound .
“4.1 Extrapolating use of intervention strategies
Are intervention strategies that have been shown to be effective in mildly to moderately affected adults also effective in children and in people (adults and children) with severe CFS/ME?
Why this is important
There is limited evidence for the use or effectiveness of strategies recommended in this guideline in these two patient groups. Population data suggest that these groups constitute a significant percentage of the population with CFS/ME. Some patient experience suggests that some of these interventions may be harmful and/or not effective”
The Baker and Shaw Summery also mentioned that antidepressants were not recommended in the guideline . “Pharmacological treatments (such as antidepressants, steroids, thyroxine in euthyroid patients) are not recommended as evidence for their overall benefit is equivocal.*”
However , the guideline did recommend the use of antidepressants , for which there was no evidence bace of benefit and recommendation was made on consensus opinion .
“1.6.3.2 Prescribing of low-dose tricyclic antidepressants, specifically amitriptyline, should be considered for people with CFS/ME who have poor sleep or pain. Tricyclic antidepressants should not be offered to people who are already taking selective serotonin reuptake inhibitors (SSRIs) because of the potential for serious adverse interactions.”
The full version of the guidelines also mention that, “ with regard to GET, because of the confusion of terminology and protocols in the studies, the GDG developed clinical scenario statements that detailed the approach rather than naming the intervention.” “In reviewing the evidence, the GDG were aware that there was a lack of consistency in terminology and an absence of trial protocols, particularly with respect to graded exercise, graded activity and pacing. This made it difficult to compare like with like across studies.” “The GDG has therefore developed detailed recommendations describing the intervention as well as recommendations about what is appropriate.”
“Both the evidence and the GDG consensus support gradual increases in aerobic exercise in people with mild to moderate CFS/ME. The patients in the wider survey did not support this view, as indicated by the response to 3a2 (see section 6.3.6). Healthcare professionals rated this as ‘uncertain’ but did not disagree with the statement. The view of the GDG was that all interventions have the potential to cause harm as well as provide benefit. GET is no different, but the overall research evidence is that the benefits outweigh any harmful effects.”
This thus raises concern on comparison across studies for GET , what interventions consist of and their definitions in research , practice and clinical guidelines and the variation , and the quality of evidence , which was initially graded as weak in an early version of the BMJ Best Practices for ME/CFS, but was then removed , as well as acknowledgement of Pace Trial Author Peter White as a reviewer .
“Graded exercise therapy and overall improvement: there is poor-quality evidence that graded exercise therapy results in greater overall improvement in symptoms and functioning.”
“Graded exercise therapy
Five RCTs were reviewed which assessed the effects of GET in patients with CFS. Sample sizes ranged from 49 to 148. Validity scores ranged from 9 (two studies) to 17 (three studies). Significant improvements in measures of fatigue and physical function were found in all five RCTs. When exercise was combined with fluoxetine there was no additional effect.” ( full guidelines NICE Cfs/ME https://www.nice.org.uk/guidance/cg53/evidence/full-guideline-pdf-196524109) ( Rona 2005 study dint find increase in physical fitness ?)
These studies and their authors can be viewed in the York Evidence review that was conducted for NICE guidelines developement for the current 2007 CFS/ME Guidelines One of these is 2005 study on the mechanism of GET by Rona Moss Morris (who is the National Adviser for IAPT LTC/MUS, whos research is also often cited to support IAPT LTC/MUS , alongside Pace Trial Authors , and who’s disclosed COI can be viewed here ) , which said “A decrease in symptom focusing rather than an increase in fitness mediated the treatment effect. Graded exercise appears to be an effective treatment for CFS and it operates in part by reducing the degree to which patients focus on their symptoms.” However , the full version of the NICE guidelines states that , “ GDG did not regard CBT or other behavioural therapies as curative or directed at the underlying disease process, which remains unknown.” Pg 278
Another paper by Rona Moss Morris in 2009 , illustrates the Bio psycho social models explanation for symptoms , and how it regards PEM /PENE .
“There is evidence that people who go on to develop post viral chronic fatigue have a tendency to label a wide range of everyday symptoms as physical in nature, negative beliefs about their experience of the illness and an all-or-nothing coping response. There is also evidence that people who have had CFS for some time, attribute a wide range of symptoms to their condition, believe the illness is largely physical in origin, and has very serious consequences. CFS patients also tend to be hypervigilant to symptom information and to maximize the extent of their symptoms and the consequences of experiencing symptoms. They are often fearful of the aftermath of over activity which is reflected in two characteristic ways of coping with the illness including a passive disengagement response or an all-or-nothing erratic pattern of behaviour. These beliefs and coping strategics are related to disability and fatigue. The implications of these findings for treatment are discussed together with the directions for future research.
The Workwell Foundation has recently written a letter on the harm of Graded Exercise Therapy and mentions biological research supporting the organic nature and mechanisms underlying patients symptoms, and importance of patients not exceeding their impaired energy limitations, and the contraindications of trying to retrain the aerobic system . There research and news , and resources can be viewed here , including a recent study showing symptom exacerbation following 2 day CPET testing . They objectively proved PEM/PENE via 2dayCPET testing for patients able to perform the test , which is used in legal litigation. “Because CPET results are virtually impossible to fake, they can be a valuable adjunct to any medical and/or legal argument.” http://www.workwellfoundation.org/wp-content/uploads/2018/05/MECFS-GET-Letter-to-Health-Care-Providers-v4-30-2.pdf
“The GDG from the 2007 NICE Guidelines for CFS/ME , supported the view that people with CFS/ME need to learn to “ ‘listen to’ body energy levels in order to manage their daily life and that sudden large increases in activity were not advisable. There was however, concern that consistently maintaining activity levels at lower than capacity would not lead to an improvement in symptoms and/or level of functioning.”
Yet , this concern is not based on evidence as , “ little or no evidence was found for the effectiveness of sleep management, rest, relaxation or pacing for people with CFS/ME.” Nor for the management of post Exertional malaise /post Exertional neuroimmune exhaustion which is referred to in the NICE guideline and NHS clinics as setbacks. “No evidence was found on the management of setbacks and therefore the GDG devised consensus recommendations.” Rather this concern corroborates with the theory that resting will result in supposed gains made via a GET program from being lost , which is described in the GET Self Help Manual.
“Even resting for a week can make it much harder to get back to where you were
on the GET programme.”
The full version of the NICE guidelines discussion of the results from the Delphi questionnaire goes on further to say that, “there is no evidence to support the ‘envelope theory’ of maintaining levels at substantially less than capacity in order to have a reserve. The results from the wider group indicated that patients generally support this approach while healthcare professionals do not.
The Guideline recommendations went on to state that their was no evidence of benefits of risk for pacing , yet made no mention of any risk for the other interventions with planned increases in activity , aerobic exercise graded exercise therapy, or Activity management , which consists all types of activity, including aerobic exercise .
Other recommendations for management of patients based on consensus not evidence , reinforced the principles of GET and Activity management , by reducing rest , sleep and maintaining exercise during Post Exertional Malaise if possible . Maintaining activity during Post Exertional Malaise seen to be important for maintain gains from GET . This was explained in the GET booklet published before the pace trial results . , which also predicted a two year maintained benefit from the intervention , whilst stating that there is no evidence for this . What the behavioural psycho social rehabilitation interventions require , how to regard any symptom exacerbation, and mechanism by which the interventions supposedly , (for which there is no objective evidence) , is explained in the pace trial treatment manuals .
The Gibson Inquiry , mentioned that NICE includes no caveats for GET , and cardiac abnormalities found in CFS/ME patients have serious implications for recommendation of GET . The earlier version of BMJ Best Practices , (which unlike NICE guidelines does include biological research on aetiology, pathology , symptom mechanism , Post Exertional Malaise , iatrogenic PEM and a critique of the BPS model) , graded GET evidence as Poor , yet this was removed , as well as acknowledgment of peter white as a reviewer , as well as the removal of a final reference in the earlier version , a 2005 study by IAPT LTC/MUS adviser Rona Moss Morris , which was included in the evidence review for NICE guidelines , which mentions the mechanism by which GET supposedly works as being a “decrease in symptom focusing rather than an increase in fitness mediated the treatment effect. Graded exercise appears to be an effective treatment for CFS and it operates in part by reducing the degree to which patients focus on their symptoms.”
Yet this assertion , is contradicted by the discussion provided on the metabolic research and post exertional malaise which showed contraindications for aerobic exertion and over exertion in the BMJ best practices on ME/CFS , as well as disproving assumptions made by Esther Crawley and her physiotherapist team that GET may help improve cardiovascular function, or the need for further study of graded aerobic exercise as supported by the Workwell Foundation , or activity management and CBT which also have planned increases in aerobic activity independent of symptoms ,or the delivery of these interventions using digital technology and telephone .
A paper written by paediatritian Esther Crawley and her physiotherapist team at Bath Services , mentions that GET may work by improving cardiovascular tolerance to exercise and gain stamina. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5947766/
However, this is a disproved assumption , and area of concern for the continuation of studies utilising interventions with planned increases in exertion and aerobic exercise , considering ME Patients have objective proven inability to reproduce the same level of exertion over consecutive days ,and impaired aerobic system which can not be retrained , as objectively identified and proved by two day CPET testing used by sports scientists at the Workwell Foundation who use oxygen utilisation to stratify severity . http://www.workwellfoundation.org/research-and-latest-news/
Patients with ME/CFS have and abnormal response to exercise , which is outlined in the Canadian Consensus Criteria guideline, and the International Consensus Guideline , which includes cardiovascular response and cardiac abnormalities , that correlate with severity, and have serious implications for GET /graded aerobic exercise , as stated in the Gibson Inquiry.
Bath services says on its website , that they only provides evidence based treatments and aim for recovery. https://web.archive.org/web/20180616104100/http://www.ruh.nhs.uk/patients/services/clinical_depts/paediatric_cfs_me/index.asp
They have, and currently continue to provide graded aerobic exercise (GET ) , Activity Management (all types of activity including aerobic exercise ) , and CBT ( challenge fear avoidance and inappropriate beliefs about symptoms and their consequences, to increase activity /exertion independent of symptoms ) , sleep restricting and reducing rest and management of PEM/PENE , all of which as stated in NICE guidelines 2007 , do not have evidence bace , and were made by opinion.
This still is no time made clear on their website , which has been changed to say that they only offer what is recommeed by NICE , and yet still state that they believe all treatment should have an evidence bace. http://www.ruh.nhs.uk/patients/services/clinical_depts/paediatric_cfs_me/index.asp
This is still the case . They are also conducting research trials to provide the retrospective evidence for NICE guidelines recommendations , and thus IAPT LTC/MUS for which they continue to be providers with the same staff at purpose built new integrated service , which the Bath service is gradually moving to .
The 2007 ME/CFS NICE Guidelines goes on to say that ,“The GDG was clear that CBT was not about unhelpful advice or dictation of illness beliefs, but about changes in lifestyle and learning to achieve improvement within the patient’s abilities. In addition, the objectives of the programme must be agreed with the patient, and they must clearly be willing to take part. The GDG did not regard CBT or other behavioural therapies as curative or directed at the underlying disease process, which remains unknown. Rather, such interventions can help some patients cope with the condition and experience improved functioning, and consequently a improved quality of life.”
However , this is not the case in practice as CBT is regarded as achieving recovery for adults and children as mentioned in recruitment for FITNET research trial on children ,which may impede natural recovery , with bath services website saying it aims for recovery . https://www.ncbi.nlm.nih.gov/pubmed/28800089
Pace Trial Manuals on pacetrial.org , describe increasing activity independent of symptoms , challenging predisposing precipitating maintaining factors according to the biopsychosocial behavioural /deconditioning model explanation for symptoms , and activity avoidance behaviour rather then recognition of PEM/PENE . Though access to these manuals seems to have been removed .
Which is repeated in the IAPT LTC/MUS Best Practices Manual , and CBT training manual . Where variation in level of activity is a coping mechanism and boom and bust cycle of activity variation due to fear avoidance and inappropriate beliefs about symptoms and their consequences , not the recognition of the objectively proven hallmark symptom called PEM/PENE which distinguishes ME from other fatiguing illnesses and idiopathic fatigue , and recognition of the underlying metabolic disruption and impaired aerobic system . [BMJ Best Practice ME/CFS]
Patients and parents require this information in order to make informed decisions in accordance with the U.K. law change to consent following the ruling in Montgomery VS Lanarkshire Health Trust , need to be informed of the risks and benefits of an interventions according to all research ,all alternatives , not the opinion of some researchers , and reliance on a reasonable body of opinion such as a guideline .
“The Supreme Court held that the question should have been about Mrs Montgomery’s likely reaction if told of the risk of shoulder dystocia. The unequivocal position was that she would have chosen to give birth by caesarean section.
The Bolam test was deemed unsuitable for cases regarding the discussion of risks with patients, as the extent to which a doctor may be inclined to discuss risks with patients is not determined by medical learning or experience.”
Clinicians needs to provide this information in order to obtain informed consent for research trials and service provision , and state where there is no evidence of benefit or safety for interventions and patient management , or objectively proven mechanism by which they work . It is thus surprising that recommendations were made when , “ before beginning their review of the evidence, the GDG agreed that they would be sceptical of any intervention that was supported by one small trial only and would not make an evidence statement on this basis.” (Pg 278 Full version NICE guidelines ) Clinicians and , guideline developers and commissioners , and policy makers need to recognise the limitations of the biopsychosocial model , and provide evidence based policy, as discussed in expectation of recovery .
It is also an ethical obligation for patients to be informed of the nature of their condition, and the identified underlying biological mechanisms of symptoms , that provides an explanation for symptoms outside of the biopsychosocial approach , which is included in the discussion section of the BMJ Best Practices for ME/CFS .yet , Underlying causes of symptoms, are not included in the scope of NICE guidelines, with the biopsychosocial framework of symptom explanations provided on the NHS , with the coinciding management advice given to patients and interventions and mechanism by which they supposedly work ,with “evidence that healthcare consultations for patients with CFS/ME may be particularly vulnerable to epistemic injustice.”
Conflicts of interest of Pace Trial author Peter White , who is doing a systematic review on medically unexplained symptoms and , Rona moss Morris COI , head of IAPT LTC /MUS declared interests https://jcoynester.wordpress.com/2016/01/05/undisclosed-conflicts-of-interest-in-a-systematic-review-protocol-of-interventions-for-medically-unexplained-symptoms/
“Prof. Rona Moss-Morris: Two authors of this study, Trudie Chalder and Kimberley Goldsmith, are colleagues of mine at King’s College London. I work with Trudie on other CFS work and with Kimberley on different work. I published a small study on GET in 2005. I am a National Advisor for NHS England for improving access to psychological therapies for long-term conditions and medically unexplained symptoms. Peter White (another author of the present study) is Chair of trial steering committee for an HTA NIHR-funded RCT I am working on with people with irritable bowel syndrome.”
NICE has also incorporated the biopsychosocial model into the completed guideline on lower back pain and sciatica , a leading cause of disability , which refers to non specific pain , and recommends psychos social rehabilitation , as has been historically and unjustly been applied to CFS/ME patients , “ for activity avoidance and behaviour when they have significant psychosocial obstacles to recovery (for example, avoiding normal activities based on inappropriate beliefs about their condition) or when previous treatments have not been effective “ .
The commissioning guideline for MUS was developed by a collaboration of organisations and ‘each member of the Joint Commissioning Panel for Mental Health received drafts of the guide for review and revision “ . These organisations included the DOH and chaired by the Royal Collage of GP and Royal Collage of Psychiatrists, although the Parliamentary Undersecretary of State for the DOH did not say who was responsible for ensuring the commissioning guidance was implemented , and “on who takes responsibility for the care of those suffering from CFS/ME, it is of course clinicians.
“They work to evidence of best practice, which is guided by NICE.” , and that the DOH accepted the WHO classification of neurological for CFS/ME . However, ME/CFS and many other conditions across several specialities , was included in the JCPMH report on MUS , which mentioned inpatient psyhco social rehabilitation centers where the medical practitioner has a specialist interest in MUS , and relapse is dependent on improvement . The JCPMH report on MUS is referenced in the full implementation guideline for IAPT LTC/MUS.
NICE currently do not have a guideline for medically unexplained symptoms . NICE has commissioned the developing of symptom based guidelines for specific conditions regarded as Functional Somatic Syndromes in the Joint Commissioning Panel for Mental Health report on MUS , eg persistent physical pain , which references non specific pain in its scope , as CFS , Fibro and Functional somatic syndromes.
Patients are within their legal rights to record consultations