The P2P Draft report is out

[daisybell]

The thing that strikes me about symptoms is that they feel so abnormal... Many of the symptoms to be checked off are things that I might have felt occasionally at some level before I got ill, but would have put them down to having done too much, or having a virus... This is not in the same league... The descriptors are the same but the feelings are incomparable, because they feel so very very wrong. And I don't know how you capture that in a questionnaire.

 

[Sasha]

The fact that "modern medicine" *still* uses the insulting term "hysterectomy" says it all...

There's nothing insulting about the term 'hysterectomy'. The 'hyster' bit comes from the Greek for 'womb' and the 'ectomy' bit means 'cutting out'. So a hysterectomy is the cutting out of the womb, just as a tonsillectomy is the cutting out of the tonsils.

There's plenty insulting about the term 'hysteria', however - the word derives from the idea of overemotionality being related to having a womb (i.e., to being a woman). It used to be thought that wombs wandered about in the body and gave rise to all sorts of symptoms.

 

[Ember]

Regarding Dr. Jason and the DePaul Questionnaire...I ask his group to post it online for the critique of patients and expert clinicians.

The DePaul Symptom Questionnaire is posted here, along with the Fennel Scale, The Chronic Fatigue Syndrome Attitudes Test Questions, the CFS Symptom Rating Form, the CFS Screening Questionnaire, the List of Services used by PWCs and the CFS Monitoring Form.

The DSQ, as shown, cuts off the left margin of the MOS Survey at the end. The complete Medical Outcomes Study: 36-Item Short Form Survey Instrument is posted here.

 

[jimells]

I think coping-style psychotherapies and activity management in the form of pacing do need more research.

I don't need an "expert" to tell me to lay down. I get that message every minute that I am vertical, in a very direct and compelling way, from the overwhelming urge to lay down.

Instead, I need the physical presence of people who can take me to the grocery and the clinic, and maybe do some regular cleaning, and help arrange for home repairs, etc. I don't think therapists are going to do that.

 

[jimells]

There's nothing insulting about the term 'hysterectomy'. The 'hyster' bit comes from the Greek for 'womb' and the 'ectomy' bit means 'cutting out'. So a hysterectomy is the cutting out of the womb, just as a tonsillectomy is the cutting out of the tonsils.

There's plenty insulting about the term 'hysteria', however - the word derives from the idea of overemotionality being related to having a womb (i.e., to being a woman). It used to be thought that wombs wandered about in the body and gave rise to all sorts of symptoms.

I don't see how one can separate the two. Regardless of the origins of the words, the concept that women are somehow more "emotional", and that those emotions somehow cause all sorts of physical ailments, is still prevalent in the medical industry and leads directly to the CBT nonsense we are still subjected to.

I've never heard a doctor refer to a "hyster". Seems like they mostly call it a "uterus", so why isn't removal called "uterectomy"?

 

[Sasha]

I don't see how one can separate the two. Regardless of the origins of the words, the concept that women are somehow more "emotional", and that those emotions somehow cause all sorts of physical ailments, is still prevalent in the medical industry and leads directly to the CBT nonsense we are still subjected to.

I've never heard a doctor refer to a "hyster". Seems like they mostly call it a "uterus", so why isn't removal called "uterectomy"?

'Uterus' is Latin for womb and 'hustera' was Ancient Greek for womb. 'Appendix' is derived from Latin, for example, so there's no rule about sticking to Greek: it could very easily have been called a 'uterectomy'.

I think we're going to have to agree to differ on this one.

 

[Sasha]

I've started a thread specifically as a repository for information to help us write our responses to the report:

http://forums.phoenixrising.me/inde...to-individual-points-in-the-p2p-report.34630/

I'd like to keep it clear of discussion - the idea is that we should be able to see there a series of posts that each address a single one of the main points of critique (or praise), and gathers the key evidence and arguments. I'm working on some points, @Bob was working on others, and anyone is free to choose a point and join in. I think we'll find it easier to respond on at least some of the report if we share out the work like this.

 

[Denise]

I've started a thread specifically as a repository for information to help us write our responses to the report:

http://forums.phoenixrising.me/inde...to-individual-points-in-the-p2p-report.34630/

I'd like to keep it clear of discussion - the idea is that we should be able to see there a series of posts that each address a single one of the main points of critique (or praise), and gathers the key evidence and arguments. I'm working on some points, @Bob was working on others, and anyone is free to choose a point and join in. I think we'll find it easier to respond on at least some of the report if we share out the work like this.

@Sasha - thanks very much for creating the separate thread! Great idea and much appreciated!

 

[Ember]

Dr. Unger and Dr. Jason both discussed the need for diagnostic tools to complement criteria. Dr. Unger concluded emphatically, “Case definition alone is going to be insufficient.” This transcript excerpt shows how far we are away, in Dr. Unger' opinion, from having validated diagnostic tools:

PROMISE IS AN NIH SPONSORED INITIATIVE TO CREATE AND VALIDATE INSTRUMENTS FOR A BROAD APPLICATION ACROSS, THIS IS THEIR QUOTE, A WIDE VARIETY OF CHRONIC DISEASE AND CONDITIONS IN THE GENERAL POPULATION. THEIR GOAL IS TO DEVELOP COMPARABILITY TO ALLOW COMPARISON ACROSS CONDITIONS. THESE INSTRUMENTS HAVE UNDERGONE A RIGOROUS EVALUATION OF RELIABLE AND VALIDITY. THEY ARE FLEXIBLE, ACCEPTABLE AND INCLUDE A VARIETY OF PLATFORMS AND AMAZINGLY KEEN [few] NUMBER OF ITEMS IN ORDER TO DEVELOP A SCORE.

NOW, HAVING SAID THAT, AT THE SAME TIME FEW WELL CHARACTERIZED INSTRUMENTS IN THE GENERAL POPULATION HAVE BEEN RIGOROUSLY EVALUATED FOR HOW THEY WILL WORK IN THIS PARTICULAR POPULATION. THIS REQUIRES MULTIPLE STUDIES AND MULTIPLE PATIENT POPULATIONS. THESE WELL VALIDATED INSTRUMENTS MAY NOT CAPTURE ALL THE ELEMENTS OF THESE DOMAIN IN ME/CFS.

JUST AS A QUICK EXAMPLE OF THE MFI 20 WHICH IS A MULTIPLE FATIGUE INVENTORY, 20 ITEMS, IN SUBSCORES YOU CAN SEE AS SHOWN IN THIS FIGURE GENERAL FATIGUE AND PHYSICAL FATIGUE ARE BOTH HAVE A CEILING EFFECT, THAT IS THE PATIENTS HAVE ALMOST MAXIMAL SCORE SO YOU'RE GOING TO BE VERY UNABLE TO USE THOSE SUBSCORES TO FOLLOW A CHANGE.

NOW, THE SELF-REPORTED MEASURES FOR CFS SPECIFIC DOMAINS, HAVE BEEN LESS INVESTIGATED. THERE HAS BEEN A RECENT REVIEW, I HAVE CITED AT THE BOTTOM. THIS REVIEW SUMMARIZES INFORMATION ON 11 ME/CFS SPECIFIC PATIENT REPORTED OUTCOMES BUT THEY HAVE MISSED THE QUESTIONNAIRE WHICH IS A NEWLY MORE NEWLY DEVELOPED. THESE CFS SPECIFIC MEASURES INCLUDE ACTIVITY, SYMPTOM, ILLNESS MANAGEMENT AND ILLNESS REPRESENTATION.

THE REVIEW IS A LITTLE DISCOURAGING IN THAT NONE HAVE PUBLISHED EVIDENCE OF
INTERPRETABILITY. THAT'S CRITICAL FOR USE AS YOU COME [outcome] MEASURE IN CLINICAL TRIALS. ALSO NO PUBLISHED EVIDENCE [of] MEASUREMENT ERROR PRECISION AND ACCEPTABILITY. POST EXERTIONAL MALAISE IS INCLUDED AS A SYMPTOM BUT THERE ARE NO DIRECT MEASURES OF IT.

WORKING IN THIS AREA WHICH IS IMPORTANT, THERE ARE LIMITATIONS AND RELYING ON PATIENT REPORTED OUTCOME MEASURES. SELF-REPORTED MEASURES OF SYMPTOMS ARE NOT FULLY OBJECTIVE. THEY CAN BE DIFFICULT TO ESTABLISH THIS MINIMAL CHANGE THAT WE HAVE BEEN TALKING ABOUT. WHAT WILL MAKE A MEANINGFUL--CLINICALLY MEANINGFUL DIFFERENCE.

AND IT CAN BE VERY CHALLENGING TO ISOLATE DOMAINS OF ILLNESS, I DREW THOSE CIRCLES LIKE THEY WERE THINGS BUT THEY'RE VERY OVERLAPPING CONCEPTS, FOR EXAMPLE MOOD AND SLEEP CAN DEFINITELY IMPACT FUNCTION AND PAIN. COGNITIVE IMPAIRMENT AND LANGUAGE PROBLEMS CAN AFFECT UNDERSTANDING AND CAPACITY FOR RESPONDING TO ALL OF THESE.

FINALLY THERE ARE REALLY IMPORTANT ASPECTS OF THE POTENTIAL FIZZ QUO LOGIC [physiologic] ABNORMALITIES IN ME/CFS THAT ARE NON-SPECIFICALLY REPRESENTED SYMPTOMS. ANOTHER WAY OF SAYING THIS, THERE'S ONLY SO MANY WAYS YOU CAN HEAL [feel] AND SO MANY UNDERLYING ISSUES. THESE INCLUDE IMMUNE ENDOCRINE AUTONOMIC AT THIS FUNCTION [dysfunction] AS JUST A START. REALLY WHOLE HI [poorly] CAPTURED IN SELF-REPORTED MEASURES (emphasis added).

Dr. Unger mentioned that the DSQ was missed during a recent review. In his summary, Dr. Jason pitched its psychometric properties, listing on his slides that the DSQ

• has algorithms to automatically score whether a person has met case definitions

• good to excellent test-retest reliability
  - Suggests that the overall instrument is a reliable measure

• Brown and Jason (2014) study indicates similar factor structures in different samples.

Concerning its dissemination:

• The DSQ is now used in countries around the world, including Canada, Mexico, Iran, Japan, England, and Norway
  
  
• Being used data collection efforts with the Solve ME/CFS Initiative, CDC Multi-site Study, Chronic Fatigue Initiative
  
  
• It is also being used in efforts to document vision-related abnormalities among patients (Hutchinson, Maltby, Bedham, and Jason (in press).

The relevant transcript excerpt highlights the DSQ's reliability and its dissemination as a data-collection tool:

THE QUESTIONNAIRE IS ONE INSTRUMENT, WE HAVE BASICALLY USED IT, IT HAS GOOD TEST RELIABILITY, IT'S BEEN DISSEMINATED NOW, IT'S USED IN DIFFERENT COUNTRIES WITHIN THE SOLVE ME/CFS INITIATIVE, THE CDC MULTI-SITE STUDY AND CHRONIC FATIGUE SYNDROME INITIATIVE. IT'S ON RED CAMP T.

 

[biophile]

I think coping-style psychotherapies and activity management in the form of pacing do need more research.

I don't need an "expert" to tell me to lay down. I get that message every minute that I am vertical, in a very direct and compelling way, from the overwhelming urge to lay down.

Instead, I need the physical presence of people who can take me to the grocery and the clinic, and maybe do some regular cleaning, and help arrange for home repairs, etc. I don't think therapists are going to do that.

True, and any therapeutic advice needs to be autonomous, but sometimes science needs to research the blatantly obvious before it is more widely accepted by others. At the moment we are recommended CBT/GET at the expense of everything else that has little or no evidence base and should be researched. Patients often go through a period where they are really struggling to deal with what is happening to them and what they have lost, so therapy may help with that if it develops into clinically significant depression and/or anxiety. Patients also often over-exert themselves in an attempt to survive or live a more normal life despite symptoms. However, I think these problems are usually caused more by the ignorance of society and lack of support than patients' need for counseling or advice. New patients are particularly vulnerable.

When my symptoms first developed, CFS as a diagnostic entity was only several years old and my complaints were initially dismissed. A few years later I went through a phase of anger and then suicidal depression, largely because of the effects symptoms were having on my quality of life without any information or acknowledgement by others that what I experienced was abnormal and not a moral weakness. It took several more years to overcome that by myself. I can't say if therapy would have actually made any difference since I didn't receive any, but I don't want to limit that option to others. Even when I was finally diagnosed with CFS, I fell for the mind over body ideology and pushed myself too hard and paid a dear price.

 

[Sasha]

People seem a bit confused by my new thread, which is clearly my fault for not describing its purpose very well - sorry, guys!

There are some introductory posts from me, but thereafter the idea is that people adopt a single point that we want to make about the P2P report - such as, 'Further BPS research is positively not wanted by patients, including more research on CBT' (which has been adopted by Bob), and make a single post on that thread that lays out the information that anyone will need to write to the NIH about that point. There should be no other posts about that topic on that thread.

Here is an example of such a post.

I'd prefer to keep all discussion off that thread so that it just acts as a depository. All discussion, topic-bagging, etc. should be done on this ("The P2P draft report is out") thread.

 

[Ren]

Question, please.

@Sasha (or to anyone): Is Phoenix Rising, as an organization, submitting comments on the draft report?

 

[Bob]

Hi Sasha,
Thanks for the clarification.
Actually, I think I'd like to 'unadopt' myself from any commitments that I might have made.
I'm working on some stuff, in my own capacity, but I don't want to take on any sort of semi-official role.
And I don't want it to seem as if I should have any sort of monopoly on responding to any issues.

I am working on a CBT related submission, but I'm just doing it in my own capacity, and I don't know if I will post anything on the forum about it, before I submit, esp considering the time scale.
And I'm not sure if I can post anything in the format that you describe, esp as some of the argument against CBT/GET are quite complex, and I'm taking my time to work through them.

(I'm working through a variety of issues, and I will hopefully make a submission.)

 

[Bob]

If anyone is wondering what they could work on, and wants something relatively easy to do, I think it would be a good idea to go through the document and look for positive sections of text that we'd like to keep in, and submit a comment praising those sections.

Responding to positive sections of the text could be very easy - much easier than critiquing negative sections. We could simple quote the relevant section of text, and say something like: "as a patient, I welcome and endorse this text, and would like it to remain in the final document." And then, if we want to, we could add any further comments that we think would be helpful to support their text.

They might receive submissions that, for example, advocate that it is premature to state that ME/CFS is not a psychiatric disease and does not have a psychological etiology. And they might receive submissions that say there is evidence that CBT/GET can be used as primary treatments. And there might be submissions advocating that PET brain scans are unreliable. etc. etc. etc. So I think we need to make submissions that support and praise all the sections of the draft that we like, otherwise we might find some of them are removed or watered down in the final document.

 

[Nielk]

I have decided, personally, not to formally comment on the P2P draft report. I am joining other patients and advocates in continuing to protest the whole process of P2P for ME/CFS.

I feel that this process should never have been chosen for this "controversial" topic. The parameters set upon it by the NIH were meant to assure an unsound, inferior result.

I am working on a letter to Sylvia Burwell, the Secretary of HHS, enumerating the reasons for my continued protest.

 

[Nielk]

This is a section of Susan Mayer's presentation at the IOM regarding the P2P process. She explains the make up of the P2P panel and the "jury model" of the process. The jury being "ignorant" and listening to evidence from the prosecution and defense in order to bring their "verdict". There is a big problem with this process. All the evidence was brought by one side, the NIH. It was only one side, the NIH who decided on who can present, for how long and on what topic. The "public", had 2 or three minutes each for a short period of questions. How balanced could the "jury's verdict" be?

http://www.tubechop.com/watch/4415144

 

[Sasha]

Question, please.

@Sasha (or to anyone): Is Phoenix Rising, as an organization, submitting comments on the draft report?

Not that I'm aware of.

 

[Ember]

The jury being "ignorant" and listening to evidence from the prosecution and defense in order to bring their "verdict".

As lumpers, the Panel members ignored statements in the Evidence Report indicating that CBT/GET treatment findings cannot be generalized to ME patients:

In summary , there is moderate strength of evidence that counseling techniques was associated with global improvement (41 to 70% vs. 25 to 31%), and low strength of evidence that counseling techniques improved overall functioning (SF-36 physical function weighted mean difference 7.73; 95% CI, 3.58 to 11.87), fatigue (27 to 76% vs. 7 to 65%), and employment outcomes in ME/CFS patients. The effects may not be generalizable to a more disabled population as no study used a case definition for ME and only one study analyzed patients fulfilling the London ME (Dowsett, 1994) case definition and may have been underpowered to detect a difference.121

GET was superior to control groups in measures of fatigue, clinical impression of change, and function. These findings however cannot be generalized to all patients with ME/CFS as no study enrolled patients whereby PEM was a diagnostic requirement (ME case definitions) and only one study performed a subgroup analysis to determine if similar results were found in patients meeting the diagnosis of ME.

 

[Sasha]

Hi Sasha,
Thanks for the clarification.
Actually, I think I'd like to 'unadopt' myself from any commitments that I might have made.
I'm working on some stuff, in my own capacity, but I don't want to take on any sort of semi-official role.

I hope I haven't made this sound too intimidating (I suspect I have!). This isn't any kind of official enterprise - I just thought it would be more efficient for us all to share the work and provide info for those who need it (which includes me, for many points).

Anyway, I'll edit you off the list of points, Bob, but if you want to reclaim any points, feel free.

I hope that some of our advocates might be working on a response that people can sign up to but I've no idea if they are. At least some are intending not to comment on specifics but to continue to protest the P2P process:

I have decided, personally, not to formally comment on the P2P draft report. I am joining other patients and advocates in continuing to protest the whole process of P2P for ME/CFS.

I can understand the objections to the process. However, the draft report has been published and the final report is on its way. My personal judgement is that it's better that I send a critique and have a chance of improving the report than not. I'll keep reading the arguments, though.

 

[Sasha]

I want to write about how the funding for ME/CFS research should be commensurate with the disease burden. I'm wondering what data we have that indicates what the burden is and how it compares to other diseases that get disproportionately more money.

I see the figure of 25% often quoted for the % of PWME who are bedbound or housebound, but what study does that come from?

What data do we have that demonstrate what a disabling illness this is, and how long it goes on for?