Jorgen Jelstad is a Norwegian journalist, author of De Bortgjemte (The Hidden not available in English yet) and blogger (http://debortgjemte.com/) who knows about ME(cfs). He has a relative with severe ME. In late December 2012, he submitted comments in response to the Norwegian Health Directorate open request for comments on the draft document “ Patients with CFS / ME: Assessment, diagnosis, treatment, rehabilitation and care.” (The final document is supposed to be available towards the end of 2013.)
Jorgen has given permission (thank you) for the Google translated version of his blog post (Høringssvar til Helsedirektoratet ) containing his comments to be reposted here.
“4. January 2013 · 12:53 pm
I spent some time at Christmas to write a submission to the Health Directorate regarding the circular is in the process of preparing for ME / CFS.The deadline was 31December, and I just did.I do not know if they take particular care to non-invited comments, but here’s at least suggestion I sent to the Health Directorate of the draft has circulated :
Its submission – draft circular on CFS / ME
Directorate of Health has issued a consultation draft circular on CFS / ME, and I allow myself to make some comments on some parts of the CMO draft “Patients with CFS / ME: Assessment, diagnosis, treatment, rehabilitation and care.”
My background to respond to the consultation:
I am a journalist and relatives of a severe ME / CFS sick, and for three years I worked on a book about the disease, published by Cappelen Damm in October 2011. The book is “The Secluded – and how ME was today’s most controversial illness.” The research work for the book, I have read thousands of book pages, research papers, doctoral theses, newspaper articles, documentaries, reports and public documents from mail records. I have participated in international academic conferences in the U.S., Canada, London and Copenhagen, as well as conferences and seminars in Norway. On the internet I have followed the research presentations and committee meetings via Webcasting. I have interviewed over a hundred people, some of them several times and several hours, and there have been patients, caregivers, researchers, physicians, nurses, physical therapists, lawyers, activists, politicians and academics. In the work I have interviewed several key researchers and clinicians in the ME / CFS community nationally and internationally. I also followed developments closely after the publication about a year ago.
I therefore believe to have skills and knowledge to comment any documentation on the research behind specific sections of the draft.
1.Page 14:“Studies show a higher frequency of trauma and psychological stress in this patient group (Heim C et al, 2006)”
This contention is not well documented in the research, and there are conflicting results. The reference referred to a study (1) which concludes with a higher frequency of childhood trauma among adult patients with CFS. There are only two studies that show such a higher frequency (the second study is from exactly the same research group – Heim et al 2009 – ref 2 below), and it may be questioned CFS diagnosis in these studies. The last of these two studies (2009) have relied on a diagnosis that gives a prevalence of CFS in the population at 2.54 per cent – that is five to ten times as high as what solid estimate prevalence studies show. An examination of the exact same patients from the study childhood trauma and CFS from 2009 show that the studied patients also had a far greater degree of depression, anxiety and post-traumatic stress than is normal for ME / CFS patients (3). Almost 90 percent of the patients in this study have, or previously had, a psychiatric diagnosis. This is far from what is normal incidence of these comorbid disorders in ME / CFS patients, and there is reason to question the patient sample in the study.
Early adverse experience and risk for chronic fatigue syndrome: results from a population-based study. Heim C et.al. Archives of General Psychiatry. 2006 Nov., 63 (11) :1258-66. http://www.ncbi.nlm.nih.gov/pubmed/17088506
Childhood trauma and risk for chronic fatigue syndrome: association with neuroendocrine dysfunction. Heim C et.al. Archives of General Psychiatry. 2009 Jan; 66 (1) :72-80. http://www.ncbi.nlm.nih.gov/pubmed/19124690
Psychiatric Comorbidity in persons with Chronic Fatigue Syndrome Identified from the Georgia population. Nater UM et.al. Psychosomatic Medicine. June 2009, 71 (5): 557-65. http://www.ncbi.nlm.nih.gov/pubmed/19414619
It is also important to be aware that there are studies that do not find any correlation between childhood trauma and ME / CFS:
Sexual abuse, physical abuse, chronic fatigue and chronic fatigue syndrome: a community-based study. Tayler RR et.al. The Journal of Nervous and Mental Disease. 2001 Oct; 189 (10) :709-15. http://www.ncbi.nlm.nih.gov/pubmed/11708672
It is also known from research that the incidence of childhood trauma appears to occur in a variety of physical illnesses (1,2). Therefore, it is somewhat strange that in this circular appears to emphasize a possible link specifically for ME / CFS, and that this is done without any of the provisions above. A relationship between a number of diseases and childhood trauma / stress can according to research having to do with this possibly affect an inflammatory response (2), but when no such nuances are highlighted in a letter about ME / CFS can be quickly perceived as “mental factors that are specific to ME / CFS ‘- that is something that is not. It is also far better documented findings in research that is not discussed in this section, so why to use some of the extremely limited space (17 lines) under “What causes the disease” to right this with (childhood) trauma is something strange, when It is currently poor evidence for this assertion. With a disease associated with many prejudices that ME / CFS, such simplified representations reinforce the erroneous attitudes to patients outside of health care – for example, an attitude that these are patients with particularly traumatic and difficult life. This should either nuanced or removed.
Association between childhood trauma and physical disorders among adults in the United States. Goodwin RD et.al. Psychological Medicine. 2004 Apr; 34 (3): 509-20. http://www.ncbi.nlm.nih.gov/pubmed/15259836
Cumulative childhood stress and autoimmune diseases in adults. Dube SR et.al. Psychosomatic Medicine. 2009 Feb; 71 (2) :243-50. http://www.ncbi.nlm.nih.gov/pubmed/19188532
2.Page 17: Occurrence
The most recent study on the incidence has also examined the incidence of use of the Canadian criteria (corresponding ICC), and it has since found an incidence of 0.1 percent (Canada Criteria) and 0.2 percent (CDC criteria) in the UK. This study is worth noting.
Prevalence of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME / CFS) in three regions of England: a repeated cross-sectional study in primary care. Nacula LC et.al. BMC Medicine 2011 Jul 28; 9:91. http://www.ncbi.nlm.nih.gov/pubmed/21794183
The emphasis of the CDC criteria (Fukuda) and ICC (Canada criteria) in favor of earlier NICE-recommended criteria is important to avoid over-diagnosis. It is also important in research to achieve the most homogeneous patient mass, which will make the findings easier to reproduce.
Should the doctor have primary responsibility for diagnosis?
Page 19: “The assessment takes place mainly in GP”
It is understandable that the Health Directorate wants the diagnosis mainly be carried out by a GP, both for practical and economic reasons. But there are several arguments against such a practice:
a) SINTEF report on ME / CFS in 2011 showed very clearly a great lack of knowledge about ME / CFS among Norwegian general practitioners – and especially among those diagnosis. Sintef survey conducted among 330 Norwegian general practitioners showed that very few (under 10 percent) were well aware of some of the published diagnostic criteria for ME / CFS. Should then GPs will be responsible for the diagnosis? And if so, how will they be able to do it?
b) Two fairly recent studies from the United Kingdom highlights the problem from point A:
In one study went through the patients referred to a specialist center for ME / CFS in the course of one year. These 260 patients had all been referred by a doctor who assumed they had ME / CFS. The specialist center examined the patients after Fukudakritieriene. It turned out that 40 percent of patients had ME / CFS according to this report (with Canada Query error rate would probably have been even higher). Over 100 of the 260 patients were misdiagnosed by their GP. Instead, they had other diagnoses such as sleep disorders, psychiatric disorders or chronic conditions that had not been discovered.
o Reference:The Newcastle NHS Chronic Fatigue Syndrome Service: not all fatigue is the same. Newton JL et.al. Journal of the Royal College of Physicians Edinburgh 2010, 40:304-7. http://www.rcpe.ac.uk/journal/issue/journal_40_4/newton.pdf
The second study was conducted at a different specialist center for ME / CFS in the UK and showed similar results. Only half of the patients referred by doctors with an estimated ME / CFS diagnosis turned out to meet this center’s criteria for diagnosis. The rest had alternative medical or psychiatric disorders. The entire 22 percent of the patients had a psychiatric disorder instead, most often depression, which could explain the symptoms. But GPs wanted thus to diagnose those with ME / CFS. * An important note: this specialist center for ME / CFS uses NICE criteria for diagnosis – that is very broad criteria.Ergo would share that would have been diagnosed with narrower criteria used was probably lower.
o Reference:Alternative diagnoses two chronic fatigue syndrome in referrals to a specialist service: service evaluation survey. Devasahayam A et.al. JRSM Short Report 2012 Jaunuary, 3 (1): 4 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3269106/
c) The key point must be the right diagnosis at the right patient, and how best to achieve this. Why do we need specialist studies for diseases such as MS, rheumatoid arthritis, lupus, etc., but not for a complex disorder that ME / CFS? Especially when research and Sintef survey shows that misdiagnosis and over diagnosis is likely to be the result of handing over this mainly to GPs. It should perhaps be emphasized to educate more ME / CFS specialists? Or at least spend more time trying to raise the level of competence of general practitioners before they are all responsible for the diagnosis? There are good examples of GPs who have extensive experience and expertise in the diagnosis of ME / CFS, so it is obviously possible to make this happen, but it requires in this case an intensive skills out among GPs. In my work on the book, I have also met GPs who have been distressed by the lack of help from specialist health care in the diagnosis of ME / CFS, as they have felt that they had sufficient expertise. Experienced ME / CFS clinicians both nationally and internationally is also quite clear that the diagnosis of ME / CFS requires a long time (1-2 hours), which can be a challenge for primary care physicians in a stressful life.
There are some signs that there is a lack of understanding in the medical community that ME / CFS is a serious disease. This despite the fact that research clearly shows that patients with ME / CFS have very strong degree of renal impairment. Several studies have been done where you have measured disability in multiple chronic diseases with the widely used measurement feature the SF-36 (1.2). In these studies have ME / CFS patients significantly lower functioning than patients with arthritis, cancer, depression, heart failure and several other chronic diseases.
Should there have been a statement about the research that shows how serious malfunction of these patients experience?
Health Status in Patients with chronic fatigue syndrome and in general population and disease comparison groups. Komaroff AL et.al. American Journal of Medicine in September 1996, 101 (3) :281-90. http://www.ncbi.nlm.nih.gov/pubmed/8873490
The functional status and well being of people with Myalgic encephalomyelitis / chronic fatigue syndrome and their carers. Nacula LC et.al. BMC Public Health. 2011: 11: 402 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3123211/?tool=pubmed
Here is a graph showing the results of SF-36 for some different diseases from study 2 above, where one can clearly see that ME / CFS patients have the lowest functional level of suffering they have studied:
It is good that emphasizes the lack of processing documentation for those patients who have ME / CFS in severe and very severe, as many patients are faced with generalized claims processing documentation, and as soon as may be pressed to implement undocumented treatment with incorrect assurances that it is research based.
I also want to comment on any of the treatment documentation in the draft on the basis of an objection taken from the consultation response from the Norwegian College of General Practice (NFA), as GPs have an important consultative body of this document. NFA writes the following in its submission: “A serious concern is that the text consistently communicate the impact of proven treatments such as cognitive therapy and customized fitness treatment.(…) The text takes many more reservations than otherwise usual when presenting efficacy studies (for example, the measure does not work at all, or that the measure has not been tested in the poorest patients).This gives the doctor the impression that there is little other than coping support to offer this group of patients, which may contribute to undue pessimism which is also provided to the patients. “
In the draft document shows Health Directorate to the conclusions of the Knowledge Centre, and there is documentation regarding cognitive therapy and GET (graded exercise therapy) explicitly. NFA believes that it should not stand in the circular that “action does not work at all, or that the measure has not been tested in the worst patients,” but it’s actually the fact that research is here – and it should be communicated. Why NFA believes that this shall be communicated is an enigma. According to a Cochrane review from 2008, the vast majority of ME / CFS patients (60 percent) null effect of cognitive therapy and / or regular medical follow-up (1). When comparing with control groups that receive only monitoring by a physician (or no follow-up), only 14 percent of those treated with cognitive therapy that has no additional effect beyond the effect of regular medical follow-up. This is also something that is confirmed in a much publicized Lancet study from 2011 that only 14 percent have an effect that can be attributed to cognitive therapy (2). The results are roughly equivalent to GET. Some simply put: a treatment of 100 people with ME / CFS with cognitive therapy, only 14 of them have any therapeutic effect. And then he has not given that many studies on cognitive therapy in ME / CFS have used very broad diagnostic criteria, which may also affect the results. The aforementioned studies may show either that good and empathetic supervision of a physician possibly far more important than treatment as cognitive therapy and GET.
At any benefit from cognitive therapy, and therefore obviously should get a quote on this (just as in other chronic diseases such as MS and cancer), should not mean that one should not inform the medical community that the majority of patients have no benefit of such therapy. When a relatively low ratio has the effect of a treatment, it is not right just to convey that “cognitive therapy has an effect” – you have to know something more about what lies behind the concept of power. If not, the risk is that there are patients who get “blamed” when the treatment is not successful – although no effect of cognitive therapy, according to research to be the most common result. A major evaluation of such rehabilitation with cognitive therapy and five GET ME / CFS specialist centers in Belgium concluded that none of the 600 patients who completed treatment experienced being healthy (3). The Belgian government’s comprehensive evaluation report concluded that “physical capacity did not change; work was reduced after treatment.”
I have met many ME / CFS patients have experienced to be met with an attitude that “if they just want enough so they are healthy enough” – and it is therefore important to communicate that doctors will usually find that psychological treatments such as cognitive therapy did not have any significant effect on their ME / CFS patients – but also that it may have the effect of a small minority. But research shows like a rather limited effect on those who benefit from it, for example, there are studies that show that cognitive therapy does not provide any increase in patients’ physical activity (4). Obviously you must state that cognitive therapy can be beneficial for some, but it is equally important that this message not sold (which has been a tendency in the ME / CFS debate). Cognitive therapy is a form of coping support – ergo it is indeed appropriate to give the impression that “we have little other than coping support to offer.” It is not “undue pessimism” to disseminate research documentation in an honest way. It appears that NFA conveys a desire to embellish research documentation because they think this will bring out a placebo effect, but this is not considered good medical practice for other conditions as far as I know.
Patients are entitled to receive fair and balanced information about treatment options to make decisions, and when doctors must be conveyed this information. I think whatever the doctors handle this in the face of patients without being unnecessarily pessimistic.
Cognitive behavior therapy for chronic fatigue syndrome in adults. Price JR et.al. Cochrane Database Systematic Reviews. 2008 July 16, (3): CD001027. http://www.ncbi.nlm.nih.gov/pubmed/18646067
Comparison of adaptive pacing therapy, cognitive behavior therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomized trial. White PD et.al. Lancet. 2011 Mar 5, 377 (9768) :823-36. http://www.ncbi.nlm.nih.gov/pubmed/21334061
Two reports from Belgium:
A. Referentiecentra voor het Chronisch vermoeidheidssyndroom (CVS). Evaluation Report 2002-2004.
b Chronisch Vermoeidheidssyndroom: diagnosis, behandeling one zorgorganisatie. KCE reports 88A, Federaal Kenniscentrum voor de Gezondheidszorg, 2008. This report is in English. https://kce.fgov.be/sites/default/files/page_documents/d20081027358.pdf
How does cognitive behavior therapy Reduce Fatigue in Patients with Chronic Fatigue Syndrome?The role of physical activity. Wiborg JF et.al. Psychologist Med. 2010 Aug; 40 (8) :1281-7. http://www.ncbi.nlm.nih.gov/pubmed/20047707
Thanks for the opportunity to provide input, and good luck with further work on what appears to be a well prepared document.”