The final evidence review for P2P on ME/CFS has been published

[Nielk]

The final evidence review has been published HERE.

 

[Valentijn]

At least it specifically recommends that the Oxford criteria not be used for research.

 

[daisybell]

And as a final paragraph, the following isn't bad!

"Studies should report findings according to important features of ME/CFS, such as postexertional malaise, neurocognitive status, and autonomic function, to identify subgroups that may respond differently to specific treatments. Studies also need to report harms more completely to help identify patients negatively affected by certain treatments. Given the devastating impact that this condition has had on patients and families, researchers planning and developing trials should consider involving the patient and/or advocate voice so that future research is relevant and meaningful to those affected by ME/CFS."

 

[Sidereal]

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a multi-system debilitating condition that often robs patients of independence and quality of life.1 It follows a relapsing and remitting course and is characterized by chronic and disabling fatigue. Various additional manifestations include neurological and cognitive changes, motor impairment, pain, sleep disturbance, and altered immune and autonomic responses.

So this isn't a disease characterised by various symptoms, it's a "condition" characterised by "manifestations" and "changes" and "responses". Language matters. This reads like something drafted by a team of lawyers, not scientists.

 

[Valentijn]

Despite a few points that are good, they still give way too much weight to poorly designed CBT and GET studies.

 

[Nielk]

There will be a patient protest tomorrow against the P2P - http://www.meadvocacy.org/disabled_americans_protest_us_national_institutes_of_health_s_p2p_meeting

 

[Hope123]

I am not familiar with this MAPP system iof research. Is this NIH funded?

Yes, if you go back to the CFSAC DHHS website, there were multiple presentations about it.

Also; quote from: http://www.ichelp.org/page.aspx?pid=747

"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), one of the National Institutes of Health (NIH), is sponsoring a new and novel research study called the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. The NIDDK MAPP Network is conducting research to help better understand the underlying causes of IC and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). MAPP embraces a systemic—or whole-body—approach by investigating potential relationships between these two urological syndromes and other overlapping conditions commonly seen in IC and CP/CPPS patients, such as irritable bowel syndrome, fibromyalgia, vulvodynia, and chronic fatigue syndrome" [End quote]


In fact, Dr. Jordan Dimitrakoff was on CFSAC because he was an investigator of MAPP and his role was to potentially provide ideas about how MAPP process, analyses, etc. could be applied to ME/CFS. However, for a while, I tried to find out exactly how many patients with ME/CFS were enrolled in MAPP (i.e. they had both ME/CFS and chronic pelvic pain) and came away with the impression that it was practically zero. Now this meeting, no one is saying MAPP includes ME/CFS patients but I don't disagree that the way MAPP was organized, researchers recruited, etc. may be helpful for ME/CFS.

 

[Hope123]

What I would suggest is people concentrate on the executive summary if one is provided. That is what most busy clinicians, researchers, policy makers, etc. will read rather than the whole document.

 

[Dolphin]

Yes, if you go back to the CFSAC DHHS website, there were multiple presentations about it.

Also; quote from: http://www.ichelp.org/page.aspx?pid=747

"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), one of the National Institutes of Health (NIH), is sponsoring a new and novel research study called the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. The NIDDK MAPP Network is conducting research to help better understand the underlying causes of IC and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). MAPP embraces a systemic—or whole-body—approach by investigating potential relationships between these two urological syndromes and other overlapping conditions commonly seen in IC and CP/CPPS patients, such as irritable bowel syndrome, fibromyalgia, vulvodynia, and chronic fatigue syndrome" [End quote]


In fact, Dr. Jordan Dimitrakoff was on CFSAC because he was an investigator of MAPP and his role was to potentially provide ideas about how MAPP process, analyses, etc. could be applied to ME/CFS. However, for a while, I tried to find out exactly how many patients with ME/CFS were enrolled in MAPP (i.e. they had both ME/CFS and chronic pelvic pain) and came away with the impression that it was practically zero. Now this meeting, no one is saying MAPP includes ME/CFS patients but I don't disagree that the way MAPP was organized, researchers recruited, etc. may be helpful for ME/CFS.

There may be a lot more ME/CFS cases than they realise in studies like MAPP. See, for example, this study

Psychosom Med. 2012 Nov-Dec;74(9):891-5. doi: 10.1097/PSY.0b013e31827264aa. Epub 2012 Oct 15.
Functional somatic syndromes: sensitivities and specificities of self-reports of physician diagnosis.
Warren JW1, Clauw DJ.
Author information

Abstract
OBJECTIVE:
Functional somatic syndromes have no laboratory or pathologic abnormalities and so are diagnosed by symptom-based case definitions. However, many studies, including recent ones, have used self-reports of physician diagnosis rather than the case definitions. Our objective was to determine the sensitivities and specificities of self-report of physician diagnosis for chronic fatigue syndrome (CFS), fibromyalgia (FM), irritable bowel syndrome (IBS), panic disorder, and migraine.

METHODS:
Each of 312 female patients with incident interstitial cystitis/bladder pain syndrome and matched population-based controls were queried on self-report of physician diagnosis and separately on established case definitions for each of these syndromes.

RESULTS:
Using the symptom-based case definitions as standards, we found that self-report of physician diagnosis did not identify 90% of the controls who had CFS, 77% who had FM, 69% who had IBS, 43% who had panic disorder, and 23% who had migraine. In addition, it missed most individuals with multiple syndromes. Findings in one cohort (controls) were confirmed in another (patients with interstitial cystitis/bladder pain syndrome).

CONCLUSIONS:
Self-report of physician diagnosis did not identify most of the three most venerable functional somatic syndromes, IBS, FM, and, especially, CFS; nor did it identify substantial minorities of individuals with panic disorder and migraine. Self-report of physician diagnosis was particularly poor in recognizing persons with multiple syndromes. The insensitivity of this diagnostic test has effects on not only prevalence and incidence estimates but also correlates, comorbidities, and case recruitment. To reveal individuals with these syndromes, singly or together, queries of symptoms, not diagnoses, are necessary.

 

[Sean]

Recovery Outcomes

The [PACE] study may also be at risk of attention bias given the total number of visits by participants were greater in the CBT (17) and adaptive pacing (16) groups compared with the usual care group (5). The nature of the approach to CBT, using providers and training manuals that teach patients that the treatment is effective, can cause an expectation bias in the direction of improvement. Additionally, there are reservations about the interpretation of the recovery results. Given that a score of 65 or less on the SF-36 physical functioning scale was defined as disability for entry into the trial, using a score of 60 or greater on the same scale to define recovery is contradictory. The authors reportedly derived their threshold for recovery based on the mean score for a normal adult minus two SDs (84 to 16). Furthermore, they defined deterioration as greater than a 20 point reduction in the SF-36, yet they defined improvement as an increase of 8 point or more. These threshold values likely favor results in the direction of improvement. For fatigue outcomes they considered recovery as a Chalder Fatigue Scale score less than 18 yet other studies have considered a score of less than 4 to indicate a return to normal.118 Finally, although statistically significant changes were noted, the meaningfulness of these change remains uncertain. For instance, the mean score of the SF-36 physical function score remained at or above 60 (used in the definition of trial recovery) for all groups, while the 6-minute walk test was much less than for normal older adults (379 meters vs. 631 meters).124

Summary of Counseling and Behavior Therapy Trials

Whether these effects can be sustained is uncertain as benefit was no longer seen in one trial that evaluated patients 5 years later. In addition, trials used various measures to detect change making it difficult to compare results and few trials reported the clinical significance, if available, of the improvement in scores. Recovery has rarely been tested and measurements used to determine effectiveness may be overestimating the effect and not reflective of true recovery.

Pages 42-43

Findings in Relationship to What Is Already Known

Recovery as an outcome was reported in few trials and the variability in definition and thresholds leave the results meaningless for comparison. In the PACE trial, the criteria for inclusion was a SF-36 physical functioning score of 65 or less (revised protocol), yet the threshold for recovery was a score of 60 or more, and the Chalder fatigue score was less than 18, while normal is considered less than 4. An ideal definition of recovery would really mean a return to baseline function, which would be unique to each individual. Since this would be a difficult measure for research purposes, refining an acceptable definition with meaningful values is needed. Another critique of this literature is that some investigators teach patients that the disease is psychologically-based and caused by misperceptions and volitional deconditioning. By then educating and training patients that they can overcome their disease by changing attitudes, patients would expect to do better and consequently they report improvement on self-reported surveys.

Pages 85-86

I also think they have been quite mindful of the potential distinction between CFS, CFS/ME, and ME.

For example:

no intervention trial used an ME case definition , and

Most of the intervention trials used the Oxford (Sharpe, 1991) or CDC (Fukuda, 1994) case definitions for inclusion and the results may not be applicable to patients meeting case definitions for ME.

(page 87)

This is long overdue and very welcome:

future research should retire the use of the Oxford (Sharpe, 1991) case definition,

(page 89)

I regard this in particular as a huge win for us:

Outcome Evaluation: Given the plethora of outcome measures, the development of a set of core outcomes including patient-centered outcomes such as quality of life, employment, and time spent supine versus active, would help guide research and facilitate future data syntheses. In 2003 Reeves and colleagues recommended using an activity recorder to quantify activity, yet no study included in our review reported on this outcome. With today’s readily available personal activity trackers that can record activity as well as physiological responses, these outcomes should be easily obtained. Recovery needs to be better defined and should include functionally meaningful outcomes. Clearly reporting harms, particularly surrounding exercise therapy and testing and treatment for specific subgroups, may help identify patients more negatively affected by these interventions. Personal activity trackers could also be used to identify harms that result in reduced activity.

(Page 90)

It is almost like they have been reading my rants about this very issue.

-----------------

I have only done a quick scan of a handful of sections, and don't have the reading capacity to do much more. But I am pretty happy with what I am seeing so far. I don't think we have anything to fear from this report. Quite the contrary.

In particular, I see nothing much in there for the PACE team and their whole CBT/GET psycho-drama morality-play approach to be too pleased about. Quite the contrary.

 

[catly]

Thankfully @Sean , all those comments that many of us made regarding the draft report HAVE helped to correct the errors, and finally, maybe have a governement issued report that shoots holes in the PACE trial!

Now, if only we could be gaurenteed that the whole P2P process will result in more funding dedicated to the biological understanding and treatment of this illness, maybe we could cheer.

 

[Sean]

all those comments that many of us made regarding the draft report HAVE helped to correct the errors,

I think it is fair to say that a lot of hard work by a lot of people over many years, is finally starting to pay off.

 

[WillowJ]

Now, if only we could be gaurenteed that the whole P2P process will result in more funding dedicated to the biological understanding and treatment of this illness, maybe we could cheer.

I think we need Congress for that, unless we can get them to move us into an Institute with available funding. That would be a useful thing to ask DHHS: house us in a regular Institute like any other proper disease.

 

[catly]

I think it is fair to say that a lot of hard work by a lot of people over many years, is finally starting to pay off.

Totally agree regarding the so many who have worked for yrs to dispel the psychological based conclusions and hope you are right about it starting to pay off!

 

[usedtobeperkytina]

I think this an example of how influencing and educating is often the best strategy when the government wants to do something. It's so hard to get the big elephant to move, to act. Once it starts moving, we don't need to tell it to stop.

Also, the federal agencies don't like to stick their neck out on making decisions without a study and a report to show their actions are well-founded. They can't just do what makes sense, like a doctor or any private group can. Before they reject or endorse anything, or chart a course, they must be able to show their decision is based on an unbiased review of the evidence. This is why there are over 1,000 committees in Washington. This is why the FDA did a committee before deciding on Ampligen. This is why they contracted with IOM. This is why, before they make any declarations on what type of studies to approve or what criteria is best for research use, they did this committee.

Don't you imagine they are getting some pressure from those with the psychosocial theories to ME/CFS? How do they respond to these medical professionals when explaining why they made whatever decision they made? They can't point to a large medical professional organization of certified specialists to back them up. All ME/CFS expert are self-declared or patient-declared with no specialized training. The psychosocial theorists can also declare themselves as experts.

The question is whether we recognize these limitations government officials have and work within the framework of what they can do or oppose it because it's not enough or because they aren't using people we want them to use or not going about it the way we want.

Do we consider opportunities to create more allies, more people who understand our plight! Or do we allow fear of other peoples' bad deeds?

To get progress, we must courageously get out of our reliable closed circle and influence and educate those with power and access.

 

[Esther12]

From what I've seen of the report I thought it seemed like they were rushed and in over their heads. They'd have been better covering less ground and being more modest in their conclusions - they should have just said that they didn't have time to do a good piece of work answering the questions asked.

It seemed like some points from patients managed to get in to the final report. It read like something written by people who disagreed with each other, but didn't take the time to try to really argue things out.

There are quite a few little inaccuracies, eg:

The authors reportedly derived their threshold for recovery based on the mean score for a normal adult minus two SDs (84 to 16)

(Also - what does 'normal' mean in the above sentence?)

It seemed like they didn't really get that likert and bimodal scoring are used for the Chalder fatigue scale, or that PACE changed the scoring for their primary outcome half-way through the trial. More importantly, they claim PACE shows improvement in employment data for CBT and GET, when it doesn't. I know someone who had written in to explain problems with their interpretation of employment data - it will be interesting to see their response to this when that is published.

They didn't seem to attempt to grapple with, or even explore, some of the most important problems around CFS.

Much mention of 'stigma', but only in the most general of terms, and as if the 'stigma' around CFS was entirely unrelated to the poor quality psychosocial research that is often tolerated here.

Having said that, a lot of CFS reports seem to be deliberately spinning the evidence, and I thought this report was just genuinely not very good. I guess that's reason to be hopeful that things are starting to improve?

PS: It could also be thanks to the work of people fighting behind the scenes that the report has been improved to being a slightly confused and incompetent mess with a few good points. If so, genuine thanks!

 

[Nielk]

"Two patient advocates were also members of the Technical Expert Panel." it doesn't mention names?

 

[taniaaust1]

Self-report of physician diagnosis did not identify most of the three most venerable functional somatic syndromes, IBS, FM, and, especially, CFS; nor did it identify substantial minorities of individuals with panic disorder and migraine. Self-report of physician diagnosis was particularly poor in recognizing persons with multiple syndromes.

Can someone please tell me what "self report of physician diagnoses" means? Does that mean reports coming from doctors about someone rather then what the patient themselves says?

**confused*

 

[alex3619]

Can someone please tell me what "self report of physician diagnoses" means? Does that mean reports coming from doctors about someone rather then what the patient themselves says?

**confused*

I am not sure myself, but my guess is this means patient report of doctor diagnosis. Like, "my doc said I have CFS".

 

[Hope123]

I am not sure myself, but my guess is this means patient report of doctor diagnosis. Like, "my doc said I have CFS".

Yes, likely what Alex said.