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Investigate MAGENTA and FITNET research trials adherence to law change to consent

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Children participating did not seem to provide informed consent from the documentation on Bristol UNI website page for the study Magenta . The same consent forms are also being used for the FITNET study . In stark contrast to harms mentioned to research participants by the Workwell Foundation when recruiting for patients to partake in objective stress testing .  MAGENTA  and FITNET studies are using GP referal for recruitment , and there is doubt weather GPs following and reliance on NICE Guidlines in its current state and pending possible review , will be aware of , and informing patients of harms of aerobic activity and impact of cognitive activity on referal to these services  , as stated in the 2015 IOM report for ME , and in accordance to all , and latest biologcial research . 

Considering the recent landmark change to UK law on consent  on 11 March 2015 , requires all harms according to all research available , no matter how small , to be informed to a patient when recommending a treatment , and that relying solely on a reasonable body of opinion , such as NICE Guidelines , is no longer allowed . The patient is also to be legally informed of alternative treatments according to ALL the research available , and that it is then for the patient to decide the significance of the harms and benefits of each treatment , not the doctor - researcher . So that a patient - research participant , can provide informed consent to a treatment  application .

Esther Crawley does not seem to adhere to law change on consent during criticism and continued ethical approval , with reliance on NICE Guidlines  , (which is pending possible review , and states that  CBT and GET should only be offered to patients who agree with this approach and doesn't comment on safety ) , exclusion of biologcial research on harm , one systematic review by Cochrane that doesn't include the latest biologcial research , and included and mentioned studies that  failed  to report harms , and came to the conclusion for GET  that "Serious side effects were rare in all groups, but limited information makes it difficult to draw firm conclusions about the safety of exercise therapy.""Data on serious adverse reactions (SARs) were available from only one trial, and SARs were rare, but too few events were reported to allow any conclusions to be drawn (Analysis 1.3).

"From the Cochrane review of CBT:"Whilst Lloyd 1993 collected data concerning the adverse effects of DLE injection, data referring to adverse effects of psychological treatment was not systematically presented by any study. One study (Sharpe 1993) noted reasons given by subjects for any deterioration during treatment, with two of four CBT participants who were subjectively ’worse’ or ’much worse’ after treatment blaming the treatment for deterioration. Huibers 2004 noted that ’no adverse event attributable to CBT was  reported’. Jason 2007 reported numbers of participants who endorsed ’worse’ or ’unchanged’ to a ’Treatment made me feel’ statement, but did not differentiate between the two categories or further investigate reasons, making inference of adverse effects impossible.""Other outcomes which are of high relevance to the individual with CFS , including adverse effects, health-related quality of life, and occupational outcomes, are also under-evaluated in the included studies." 

Ethical approval for MAGENTA excluded what biologcial research on harm of aerobic exercise will be given to patients,  as none is provided on the information sheets regarding side effects , which stated that studies show no side effects from these treatments . Only one systematic review of CBT and GET studies are used to make this judgement, (which stated that most studies failed to report harms) . Yet this is used to inform patients of safety and  side effects  , and solely used , which does not adhere  to the  law change to consent , to  inform of harms according to ALL research , for the patient / research participant to determine the significance of harm once presented with all the information  ,not the doctor .  The statement that their are no side effects from these treaments dismisses objective proof of post exertion malaise by the Workwell Foundation , biochemisty explaining impaired energy metabolism and underlying explanation of post exertion malaise  by the Open Medicine Foundation , and harm and intolerance of exertion by the IOM report for ME 2015 following assessment of the research literature . FITNET study mentions an expected adverse effect of participants  becoming bed bound , and only non expected adverse effects to reported to the sponsor of the study ,  yet MAGENTA makes no mention of adverse effects with increase in exertion . 

Lack of  informing  patients of high number of patient reported harm in surveys conducted by the ME Association and Action for ME , which both found high rates of harm from GET and greater benifit from pacing , which is supported by the energy metabolism research on ME patients , and objective research by the Workwell Foundation , informing the recommedation of remaining within anerobic threshold . The harms of exercise according to the ICC clinical primer and Institute of Medicine clincial primer  and IACFS/ME conference clinical primer , and latest Metabolomics and wider biologcial research .

The GMC has also stated in a previouse complaint against Esther Crawly that “The Case Examiners have reviewed all the documents provided by the complainants and Dr Crawley and cannot find any evidence from peer-reviewed randomised controlled trails that demonstrates similarities/differences of CFS/ME in adults and children” General Medical Council 6th June 2011 . Yet ethical approval of MAGENTA states that children with ME are different to adults , and as a result the study could not be done on adults first . "The Committee discussed the risk of harm to the participants and noted that the PACE results had been interpreted to suggest that GET could be harmful in children. The Committee agreed that what happens with children with CFS/ME is not the same as what happens in adults with the same disease and noted that the PACE trial was carried out in adults which meant that simply carrying out the MAGENTA trial in adults first may not provide the evidence that it would be safe to carry out in children." Though the statement made  in MAGENTA participant information sheeted on absence of side effects are based on studies conducted on adults , and where majority of the studies on GET have been identified by the Cochran review , to have omitted  the reporting of  harms."We have used both treatments in our service and we are not aware of side effects. Studies in adults have also not shown that there are any side effects of these two treatments. "  . 

Esther Crawley also mentioned on Bristol Radio that there is no harm of aerobic Graded exercise , and CBT to increase cognitive activity ( aim of 8 hours a day )  and school attendance for FITNET  ,  when asked if she was adhering to the law change to consent and informing her research participants  of harms and alternatives . Therefore , patients on her studies area not informed of harm and alternatives , and yet has passed ethical approval . Alternative  treatment of underlying personal biochemistry #DrAmyYasko , investigations and treatment offered outside the NHS , mentioned in the ICC clinical primer and offered at Breakspear Hospital , and energy conservation to remain below anerobic threshold #workwellfoundation ) .

Patients and research participants to be informed of biologcial treatment trials , worldwide biological  research available on harms of exercise and nature of ME classified as a mutisystemic disease and alternative diagnostic criteria and clinical primers to NICE Guidlines  (ICC ,CCC , IOM IACFS /ME clincial primer ) , research presented on harms of exercise and metabolic dysfunction presents at the Invest In ME conferences ,  IACFS/ME 2016 conference , and 2015 Institute of medicine report on ME , which states that any exertion (cognitive , physical and emotional ) adversely affects patients in multiple organ systems . The Workwell Foundation has proven with two day CPET (cardiac pulmonary exercise test ) testing,  that ME patients have impaired aerobic metabolism , can not perform at the same level over consecutive days , and stress the harm of recommedation of aerobic activity for ME patients . 

This "PACE Trail for kids" called MAGENTA , does not reference the studies used to make this statement on safety  . "We have used both treatments in our service and we are not aware of side effects. Studies in adults have also not shown that there are any side effects of these two treatments. " This is concerning cosidering most studies do not report harms , as also stated by the Cochran review , which mentioned only 1 study on GET reporting harms  . PACE trial was also found to have overstated the benifits of these treatments , and over 100 scientists have signed an open letter for its retraction.  

There is no feedback system to GP or NICE on harms of GET , as only a non completion form is sent to the GP . See #harmedbyGET for some patient testimonials and the PACE trial participants testimonials used in the tribunal to release the data . Please use the #harmedbyGET and comment on this petiton to share your experience . MAGENTA is only recording exercise and no other activity and so the affect of post exertion malaise on daily living activities , and reduced performance level over consequitive days , as noted by the Workwell Foundation and IOM report ,as well as impact of cognitive activity , may well not be accounted for . 

 MAGENTA is currently recruiting on a large scale  - uses aerobic exercise and increases the heart rate , which is specifically advised against , by #workwellfoundation who identified a damaged aerobic system in ME Patients . As well as need to inform participants of the recent downgrade of these treatments by #ahrqreview , and recent publication of metabolomics studies by #openmedicinefoundation who discovered the biochemical signitures for ME , which  identified that patients are in a hypometabolic state , and have impaired energy metabolism due to cell danger response   . Aerobic activity , with increasing intensity causes longterm damage to skeletal muscle in ME patients , and a systematic review of harms , as well as other supporting research , and research showing  biological harm of exercise   , and the biochemistry of these patients resulting in increased lactate production  as a result of impaired glycolysis . 

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