Tuesday, June 17, 2014

HHS request for info on Diagnosis and Treatment of ME/CFS

http://regulations.justia.com/regulations/fedreg/2014/06/17/2014-14084.html

[Federal Register Volume 79, Number 116 (Tuesday, June 17, 2014)]
[Notices]
[Pages 34538-34539]
From the Federal Register Online via the Government Printing Office
[www.gpo.gov]
[FR Doc No: 2014-14084]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Diagnosis and Treatment of Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for scientific information submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review of Diagnosis and
Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
(ME/CFS), which is currently being conducted by the Evidence-based
Practice Centers for the AHRQ Effective Health Care Program. Access to
published and unpublished pertinent scientific information will
improve the quality of this review. AHRQ is conducting this systematic
review pursuant to Section 1013 of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, Public Law 108-173, and
Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

DATES: Submission Deadline on or before July 17, 2014.

ADDRESSES: Online submissions:
http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/.
Please select the study for which you are submitting information from
the list to upload your documents. Email submissions:
src.org">SIPS@epc-src.org.

Print Submissions

Mailing Address: Portland VA Research Foundation, Scientific Resource
Center, ATTN: Scientific Information Packet Coordinator, PO Box 69539,
Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.): Portland VA Research Foundation,
Scientific Resource Center, ATTN: Scientific Information Packet
Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 71,
Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262
ext. 58653 or Email: src.org">SIPS@epcsrc.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Effective Health Care (EHC) Program
Evidence-based Practice Centers to complete a review of the evidence
for Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic
Fatigue Syndrome (ME/CFS).

   The EHC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews.
In order to do so, we are supplementing the usual manual and
electronic database searches of the literature by requesting
information from the public (e.g., details of studies conducted). We
are looking for studies that report on Diagnosis and Treatment of
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), including
those that describe adverse events. The entire research protocol,
including the key questions, is also available online at:
http://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1906#8766.

   This notice is to notify the public that the EHC program would find
the following information on Diagnosis and Treatment of Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

-   A list of completed studies your company has sponsored for this
indication. In the list, indicate whether results are available on
[[Page 34539]] ClinicalTrials.gov along with the ClinicalTrials.gov
trial number.

-   For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: Study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.

-   A list of ongoing studies your company has sponsored for this
indication. In the list, please provide the ClinicalTrials.gov trial
number or, if the trial is not registered, the protocol for the study
including a study number, the study period, design, methodology,
indication and diagnosis, proper use instructions, inclusion and
exclusion criteria, and primary and secondary outcomes.

-   Description of whether the above studies constitute ALL Phase II
and above clinical trials sponsored by your company for this
indication and an index outlining the relevant information in each
submitted file.

   Your contribution is very beneficial to the Program. The contents
of all submissions will be made available to the public upon request.
Materials submitted must be publicly available or can be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the Effective Health Care
Program. This is a voluntary request for information, and all costs
for complying with this request must be borne by the submitter.

   The draft of this review will be posted on AHRQ's EHC program Web
site and available for public comment for a period of 4 weeks. If you
would like to be notified when the draft is posted, please sign up for
the email list at:
http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.

   The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions. The entire research
protocol, is also available online at:
http://effectivehealthcare.AHRQ.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1906#8766.

Key Questions (KQs)

   1. What methods are available to clinicians to diagnose ME/CFS and
how do the use of these methods vary by patient subgroups?
   A. What are widely accepted diagnostic methods and what conditions
are required to be ruled out or excluded before assigning a diagnosis
of ME/CFS?
   B. What is the accuracy and concordance of diagnostic methods?
   C. What harms are associated with diagnosing ME/CFS?
   2. What are the (a) benefits and (b) harms of therapeutic
interventions for patients with ME/CFS and how do they vary by patient
subgroups?
   A. What are the characteristics of responders and non-responders to
interventions?

PICOTS (Population, Intervention, Comparator(s), Outcomes, Timing, Setting)

Population(s)

   1. Include:

A. For KQ 1: Symptomatic adults (aged 18 years or older) with fatigue
B. For KQ 2: Adults aged 18 years or older, with ME/CFS, without other
underlying diagnosis

   2. Exclude:

A. Children and adolescents
B. Patients with other underlying diagnosis

Interventions

   1. Include:

A. For KQ1: Case definitions: e.g., Fukada/CDC, Canadian,
International and others
For KQ2: symptom-based medication management (immune modulators, beta
blockers, antidepressants, anxiolytics, stimulants), forms of
counseling and behavior therapy, graded exercise programs,
complementary and alternative medicine (acupuncture, relaxation,
massage, or other), and transcutaneous electrical nerve stimulation.

Comparators

   1. Include:

A. For KQ1: Diagnostic accuracy studies and diagnostic concordance
studies with comparators
B. For KQ2: Placebo or no treatment/usual care, other active
interventions (including combination therapies and head-to-head
trials)

Outcomes

  1. Include:

A. For KQ1: Sensitivity, specificity, positive predictive value,
negative predictive value, positive likelihood ratio, negative
likelihood ratio, C statistic (AUROC), net reclassification index;
concordance, any potential harm from diagnosis (such as psychological
harms, labeling, risk from diagnostic test, misdiagnosis, other)
B. For KQ2: Overall function (i.e., 36-item Short Form Survey
[SF-36]), quality of life, days spent at work/school, proportion
working full or part time, fatigue (Multidimensional Fatigue Inventory
[MFI] or similar), adverse effects of interventions, withdrawals and
withdrawals due to adverse events, rates of adverse events due to
interventions

Timing

  1. Include: 12 weeks or longer

Setting

  1. Include: Clinical settings

   Dated: June 3, 2014.
Richard Kronick,
AHRQ Director. [FR Doc. 2014-14084 Filed 6-16-14; 8:45 am]
BILLING CODE 4160-90-M

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