The Systematic Review Report for Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS); Notice of Availability, 2924-2926 [2023-00813]
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Federal Register / Vol. 88, No. 11 / Wednesday, January 18, 2023 / Notices
Conditions (List), and research
regarding certain health conditions
related to the September 11, 2001,
terrorist attacks.
Title XXXIII of the PHS Act
established the WTC Health Program
within the Department of Health and
Human Services. The WTC Health
Program provides medical monitoring
and treatment benefits to eligible
firefighters and related personnel, law
enforcement officers, and rescue,
recovery, and cleanup workers who
responded to the September 11, 2001,
terrorist attacks in New York City, at the
Pentagon, and in Shanksville,
Pennsylvania (responders), and to
eligible persons who were present in the
dust or dust cloud on September 11,
2001, or who worked, resided, or
attended school, childcare, or adult
daycare in the New York City disaster
area (survivors).
The Administrator is responsible for
the administration of the WTCHP–
STAC. CDC and NIOSH provide
funding, staffing, and administrative
support services for the WTCHP–STAC.
The WTCHP–STAC’s charter was
reissued on May 12, 2021, and will
expire on May 12, 2023. In accordance
with 42 U.S.C. 300mm–22(a)(6)(G)(i)(II),
the Administrator must ask the
WTCHP–STAC to review and evaluate
any substantive amendment to any
existing WTC Health Program policy or
procedure.
Matters To Be Considered: The agenda
will include presentations on the state
of the WTC Health Program, the
Program’s research activities, and
uterine cancer coverage. There will be a
presentation and discussion about
substantive amendments to the existing
Policy and Procedures for Adding NonCancer Health Conditions to the List of
WTC-Related Health Conditions. The
amendments are intended to clarify the
evaluation criteria used to assess the
likelihood of a causal association
between 9/11-related exposures and a
health condition in the 9/11-exposed
population. The revision also clarifies
the nature of the rationale that provides
the basis for the WTCHP–STAC
recommendations.
The amended draft Policy and
Procedures for Adding Non-Cancer
Health Conditions to the List of WTCRelated Health Conditions as well as the
agenda for this meeting are available on
the WTC Health Program website at
https://www.cdc.gov/wtc/stac_
meeting.html. Agenda items are subject
to change as priorities dictate.
Public Participation
Interested parties may participate by
submitting written views, opinions,
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recommendations, and data. You may
submit comments on any topic related
to the matters to be discussed by the
Committee. Comments received,
including attachments and other
supporting materials, are part of the
public record and subject to public
disclosure. Do not include any
information in your comment or
supporting materials that you consider
confidential or inappropriate for public
disclosure. If you include your name,
contact information, or other
information that identifies you in the
body of your comments, that
information will be on public display.
CDC will review all submissions and
may choose to redact, or withhold,
submissions containing private or
proprietary information such as Social
Security numbers, medical information,
inappropriate language, or duplicate/
near duplicate examples of a mass-mail
campaign. CDC will carefully consider
all comments submitted into the docket.
CDC does not accept comments by
email.
Oral Public Comment: The public is
welcome to participate, via Zoom,
during the public comment period on
February 9, 2023, from 1:30 p.m. to 2:00
p.m. Each commenter will be provided
up to five minutes for comment. A
limited number of time slots are
available and will be assigned on a firstcome-first-served basis.
Procedure for Oral Public Comment:
Members of the public who wish to
address the WTCHP–STAC during the
oral public comment session at the
February 9, 2023, WTCHP–STAC
meeting must sign up to speak by
providing their name to Ms. Mia
Wallace, Committee Management
Specialist, via email at MWallace@
cdc.gov, by February 3, 2023. Zoom
instructions and participation details
will follow.
Written Public Comment: Written
comments will also be accepted per the
instructions provided in the Addresses
section above. Written public comments
received prior to the meeting will be
part of the official record of the meeting.
The docket will close on February 9,
2023.
Policy on Redaction of Committee
Meeting Transcripts (Public Comment):
Transcripts will be prepared and posted
to https://www.regulations.gov within
60 days after the meeting. If individuals
making a comment give their name, no
attempt will be made to redact the
name. NIOSH will take reasonable steps
to ensure that individuals making
public comments are aware that their
comments (including their names, if
provided) will appear in a transcript of
the meeting posted on a public website.
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Such reasonable steps include a
statement read at the start of the meeting
stating that transcripts will be posted,
and names of speakers will not be
redacted. If individuals in making a
statement reveal personal information
(e.g., medical information) about
themselves, that information will not
usually be redacted. The CDC Freedom
of Information Act coordinator will,
however, review such revelations in
accordance with the Freedom of
Information Act and, if deemed
appropriate, will redact such
information. Disclosures of information
concerning third party medical
information will be redacted.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2023–00784 Filed 1–17–23; 8:45 am]
BILLING CODE 4163–18–P
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
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.
SUMMARY:
The final document is available
January 18, 2023.
DATES:
E:\FR\FM\18JAN1.SGM
18JAN1
Federal Register / Vol. 88, No. 11 / Wednesday, January 18, 2023 / Notices
The document may be
found in the docket at
www.regulations.gov, Docket No. CDC–
2021–0053 in the Supporting Materials
tab and at https://www.cdc.gov/me-cfs/
programs/evidence-review.html.
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: cfs@cdc.gov.
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 thirtyfive 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)
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ADDRESSES:
VerDate Sep<11>2014
17:41 Jan 17, 2023
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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 participantreported outcomes should have been
rated high risk of bias or should be
PO 00000
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2925
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 metaanalysis 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/
E:\FR\FM\18JAN1.SGM
18JAN1
2926
Federal Register / Vol. 88, No. 11 / Wednesday, January 18, 2023 / Notices
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 https://www.cdc.gov/
me-cfs/programs/evidence-review.html.
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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–23–22IJ]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
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Jkt 259001
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Evaluation of
safe spaces in CDC-directly funded
community-based organizations
(CBOs)’’ to the Office of Management
and Budget (OMB) for review and
approval. CDC previously published a
‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on August
30, 2022, to obtain comments from the
public and affected agencies. CDC
received one non-substantive comment
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
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Proposed Project
Evaluation of Safe Spaces in CDCdirectly funded Community-based
Organizations (CBOs)—New—National
Centers for HIV, Viral Hepatitis, STD,
and TB Prevention (NCHHSTP), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
The CDC-funded HIV prevention
program for young men of Color who
have sex with men (YMSM) and young
transgender persons (YTG) of Color
employs an innovative strategy to
address the social determinants of
health (e.g., housing, employment) that
contribute to health inequities and
impact HIV outcomes: safe spaces. Safe
spaces are culturally, linguistically, and
age-appropriate physical spaces for
engaging people who are at increased
risk for HIV and providing HIV
prevention and care activities. Under
this program, funded community-based
organizations (CBOs) must address at
least two social determinants of health
within their safe spaces. CBOs will
employ a community-driven approach
and work with people who are at
increased risk for HIV to select social
determinants of health with the most
potential to reduce barriers to accessing
HIV prevention and care services and
promote health equity.
The purpose of this data collection is
to assess the implementation of safe
spaces, participant perceptions about
the role of space spaces in addressing
social determinants of health and
promoting HIV prevention and care, and
the association between safe space
implementation and HIV process and
outcome indicators. The primary
objectives of this data collection are to
obtain data to: (a) describe the
implementation of safe spaces; (b) to
describe the impact on participants
served; and (c) identify successful
models for safe spaces to inform other
CBOs and CDC.
By describing safe spaces and their
impact on HIV-related outcomes, this
data collection provides an important
data source for evaluating a public
health strategy aimed at reducing new
infections, increasing HIV testing, and
prioritizing populations at high risk for
acquiring HIV.
CDC requests approval for a two-year
information collection. Data are
collected through surveys with
participants of the safe spaces and
phone-based interviews conducted with
safe space staff. Persons attending the
safe spaces are young men who have sex
with men and young transgender
persons of Color over the age of 18. A
E:\FR\FM\18JAN1.SGM
18JAN1
]]>Agencies
[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Pages 2924-2926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00813]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
www.regulations.gov, Docket No. CDC-2021-0053 in the Supporting
Materials tab and at https://www.cdc.gov/me-cfs/programs/evidence-review.html.
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: [email protected].
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 https://www.cdc.gov/me-cfs/programs/evidence-review.html. 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
