Notice2023-00813
The Systematic Review Report for Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS); Notice of Availability
Primary source
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Published
January 18, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the availability of the final systematic review report titled "Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)." The report is accompanied by a summary of public comments.
Full Text
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<title>Federal Register, Volume 88 Issue 11 (Wednesday, January 18, 2023)</title>
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[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Pages 2924-2926]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00813]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2021-0053]
The Systematic Review Report for Diagnosis and Treatment of
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS); Notice of
Availability
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS), announces the
availability of the final systematic review report titled ``Diagnosis
and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
(ME/CFS).'' The report is accompanied by a summary of public comments.
DATES: The final document is available January 18, 2023.
[[Page 2925]]
ADDRESSES: The document may be found in the docket at
<a href="http://www.regulations.gov">www.regulations.gov</a>, Docket No. CDC-2021-0053 in the Supporting
Materials tab and at <a href="https://www.cdc.gov/me-cfs/programs/evidence-review.html">https://www.cdc.gov/me-cfs/programs/evidence-review.html</a>.
FOR FURTHER INFORMATION CONTACT: Anindita Issa, MD, National Center for
Emerging and Zoonotic Infectious Diseases, Centers for Disease Control
and Prevention, 1600 Clifton Road NE, Mailstop H24-12, Atlanta, Georgia
30329; Telephone: 404-718-3959; Email: <a href="/cdn-cgi/l/email-protection#96f5f0e5d6f5f2f5b8f1f9e0"><span class="__cf_email__" data-cfemail="d5b6b3a695b6b1b6fbb2baa3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In 2022, the systematic review titled
``Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue
Syndrome (ME/CFS)'' conducted by the Pacific Northwest Evidence-Based
Practice Center at Oregon Health and Science University, concluded that
there is limited evidence on effective treatments for ME/CFS. The
review updates a 2014 Agency for Healthcare Research and Quality
(AHRQ)-funded review and its 2016 addendum. It also expands upon the
prior AHRQ review by including children as well as adults, evaluating
harms as well as benefits of diagnosis, and evaluating effects of
treatment on depression, anxiety, sleep quality, pain, and other
symptoms associated with ME/CFS in addition to fatigue, function, and
quality of life. The report evaluates the quality of the scientific
literature and does not make recommendations or guidelines. While
improving clinical care remains a critical issue, the lack of
sufficient evidence from the review resulted in the decision for CDC
not to proceed with developing clinical management guidelines.
On May 17, 2021, CDC published a notice in the Federal Register (87
FR 26733) requesting public comment on the draft report of the
systematic review for ME/CFS. One hundred and thirty-five commenters
provided feedback including those from academia, professional
organizations, advocacy groups, and the public. Some of the comments
received were from organizations that represented patient advocacy
groups. CDC highly values insights gained from these public comments
and especially thanks patients living with ME/CFS, who shared their
personal experiences in this public forum.
Comments were centered around several themes. All comments were
carefully reviewed and considered by CDC. Themes from the comments
included (1) concerns with cognitive behavioral therapy and graded
exercise therapy; (2) personal testimonials; (3) inclusion of studies
with high risk of bias; (4) exclusion of certain studies on harms
evidence; (5) concerns with case definitions and impact on the
systematic review; (6) interpretation of results; (7) CDC programmatic
concerns and recommendations; and (8) recommended references.
Comments: Concerns with cognitive behavioral therapy (CBT) and
graded exercise therapy (GET): Commenters expressed concern with
inclusion of the CBT and GET in the systematic review, including
personal testimony of harms experienced after attempting treatment with
CBT or GET, and critiques of the proposed mechanism (or lack of) of CBT
or GET.
Response: CDC acknowledges the concerns that commenters have about
the inclusion of CBT and GET in this systematic review. The authors of
this systematic review report were aware of the criticisms of CBT and
GET as treatments for ME/CFS. The studies for CBT and GET were included
in the report because they met the inclusion and exclusion criteria of
this systematic review protocol, and the limitations of the evidence on
these therapies were described in the report as well. The purpose of
this systematic review was to provide a summary of available published
literature, including limitations. This systematic review does not make
treatment recommendations, and therefore, does not recommend GET or
CBT.
Comments: Personal testimonials: These testimonials spoke to the
sincere frustration and desperation experienced by many patients with
ME/CFS, including difficulty finding providers familiar with ME/CFS,
struggles during and after attempted treatment with GET or CBT, and the
impact of ME/CFS on their daily lives.
Response: CDC appreciates the patients living with ME/CFS to share
their stories and acknowledges the struggles that they face on a daily
basis. CDC highly values insights gained from these public comments.
Some patients felt that this systematic review was recommending
treatment with GET or CBT. However, the purpose of this systematic
review was to provide a summary of available published literature,
including limitations. This systematic review does not make treatment
recommendations, and therefore, does not recommend GET or CBT.
Comments: Inclusion of studies with high risk of bias: Commenters
expressing concern that unblinded trials and studies reporting
participant-reported outcomes should have been rated high risk of bias
or should be downgraded unless there were other methodological
limitations.
Response: CDC recognizes commenters' concerns about such studies.
For interventions where blinding is not possible, we followed the
standard approach used in many other systematic evidence reviews and
downgraded for open-label design, but did not necessarily downgrade to
high risk of bias unless there were other methodological limitations.
Comments: Exclusion of certain studies on harms evidence:
Commenters suggest that the review missed potentially relevant evidence
on harms by excluding observational studies and patient surveys.
Response: CDC understands commenters' concern about exclusion of
these studies. We will take them into consideration for future
systematic reviews. This review focused on randomized controlled trials
(RCT) for evaluation of benefits and harms of treatments because
observational studies and non-RCTs are susceptible to bias and
confounding, particularly for more subjective outcomes like those
evaluated in this report.
Comments: Concerns with case definitions and impact on the
systematic review: Some commenters suggested the removal of studies
that used older case definitions for the inclusion of this review.
Response: CDC respects the reasons for commenters' concerns with
the case definitions used in the report, as many case definitions have
emerged over the past several decades. To address the issue of the
multitude of case definitions, regrouped analyses were performed for
various case definitions.
Comments: Interpretation of results: Commenters questioned the use
and interpretation of meta-analysis in the systematic review, due to
high heterogeneity, low strength of evidence, and high risk of bias
studies.
Response: CDC appreciates commenters' concerns with meta-analysis
methodology. In the revision we incorporated some of these comments and
added more details to address these concerns. Essentially, the meta-
analysis results were restructured for visualization and to facilitate
the interpretation of results, thus overcoming this challenge and
allowing for useful information to be reviewed.
Comments: CDC programmatic concerns and recommendations: Commenters
included requests or recommendations to the CDC ME/CFS program
regarding future research and/or guidelines.
Response: CDC appreciates the comments for improving the CDC ME/
[[Page 2926]]
CFS program and will address them with leadership during program
planning activities.
Comments: Recommended references: Commenters suggested additional
information available on websites and in scientific publications.
Response: CDC recognizes the importance of reviewing these
suggested references. Each suggested reference was assessed for this
current review with pre-established inclusion/exclusion criteria. For
future systematic reviews CDC may consider different criteria, which
may allow for taking the suggested references into further
consideration.
Based on public comments, CDC revised the final report to include
(1) information about the decision not to proceed with developing
clinical management guidelines; (2) regrouping of plots for the meta-
analysis by case definition to facilitate the interpretation of results
by various case definitions; (3) regrouping limitations into two major
categories (study and clinical trial limitations and limitation in
methods used to conduct the review); and (4) adding a description about
the importance of collecting common data elements via standardized
instruments or other assessment tools. The final report and a thematic
summary of responses to public comments can be found in the Supporting
Materials tab of the docket and at <a href="https://www.cdc.gov/me-cfs/programs/evidence-review.html">https://www.cdc.gov/me-cfs/programs/evidence-review.html</a>. Although ultimately, at this time, CDC did not
find sufficient evidence from the review to proceed with the
development of clinical management guidelines for ME/CFS, the review
was instrumental in spotlighting the research gaps in the currently
available literature, and consequently, possible improvements for
future clinical trial design and ways to leverage funding resources for
clinical trials.
Dated: January 11, 2023.
Tiffany Brown,
Acting Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2023-00813 Filed 1-17-23; 8:45 am]
BILLING CODE 4163-18-P
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