Notice2024-28830
Supplemental Evidence and Data Request on Medical Care for Adults With Down Syndrome
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 9, 2024
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 on Medical Care for Adults with Down Syndrome, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 89 Issue 236 (Monday, December 9, 2024)</title>
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[Federal Register Volume 89, Number 236 (Monday, December 9, 2024)]
[Notices]
[Pages 97618-97619]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28830]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Medical Care for Adults
With Down Syndrome
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submission.
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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 on Medical Care for
Adults with Down Syndrome, which is currently being conducted by the
AHRQ's Evidence-based Practice Centers (EPC) Program. Access to
published and unpublished pertinent scientific information will improve
the quality of this review.
DATES: Submission Deadline on or before January 8, 2025.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#8ce9fcefccede4fefda2e4e4ffa2ebe3fa"><span class="__cf_email__" data-cfemail="0d687d6e4d6c657f7c2365657e236a627b">[email protected]</span></a>.
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Kelly Carper, telephone: 301-427-1656
or email: <a href="/cdn-cgi/l/email-protection#a3c6d3c0e3c2cbd1d28dcbcbd08dc4ccd5"><span class="__cf_email__" data-cfemail="4421342704252c36356a2c2c376a232b32">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Medical Care for
Adults with Down Syndrome. AHRQ is conducting this review pursuant to
section 902 of the Public Health Service Act, 42 U.S.C. 299a.
The EPC 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 Medical Care for Adults with Down Syndrome. The entire
research protocol is available online at: <a href="https://effectivehealthcare.ahrq.gov/products/care-adults-down-syndrome/protocol">https://effectivehealthcare.ahrq.gov/products/care-adults-down-syndrome/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Medical Care for Adults with Down Syndrome
helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. In the list, please indicate whether results
are available on <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>
trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, a summary, including the following elements, if
relevant: 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.
[ssquf] A list of ongoing studies that your organization has
sponsored for this topic. In the list, please provide the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number or, if the trial is not registered, the
protocol for the study including, if relevant, a study number, the
study period, design, methodology, indication and diagnosis, proper use
instructions, inclusion and exclusion criteria, and primary and
secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this topic and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on topics not included
in the review cannot be used by the EPC 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 EPC Program
website 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: <a href="https://effectivehealthcare.ahrq.gov/email-updates">https://effectivehealthcare.ahrq.gov/email-updates</a>.
The review will answer the following questions. This information is
provided as background. AHRQ is not requesting that the public provide
answers to these questions.
Key Questions (KQ)
1. What are the benefits, harms, and considerations of screening
and diagnostic interventions, for co-occurring medical and behavioral
health conditions in adults with Down syndrome?
2. What are the benefits and harms, and considerations of
interventions to treat co-occurring medical and behavioral health
conditions specifically in adults with Down syndrome?
Contextual Questions (CQ)
1. What conditions occur at an increased or decreased prevalence in
adults with Down syndrome compared to the general adult population. How
does prevalence vary by age/decade of age, gender, setting (rural), and
race/ethnicity?
2. How do clinical symptoms and the presentation of common co-
occurring behavioral/mental health conditions (e.g., anxiety and
depression) differ among adults with Down syndrome compared to their
presentation in the general adult population?
[[Page 97619]]
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)
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PICOTS KQ1 KQ2
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Population....................... Adults 18+ years of age with Down Adults 18+ years of age with Down
syndrome. syndrome
Subgroups: demographics (age, race, Subgroups: demographics (age, race,
ethnicity, gender), geography (rural ethnicity, gender), geography (rural
and urban), socioeconomic status. and urban), socioeconomic status.
Intervention..................... Screening/diagnostic tests for co- Treatment interventions for co-
occurring medical conditions in occurring medical conditions in
adults with Down syndrome. adults with Down syndrome.
Comparator....................... Alternative test for screening/ For all conditions, compared with
diagnosis or no screening. usual care or alternative
intervention for treatment.
Outcome.......................... Benefits: accurate diagnosis, time to Intermediate outcomes:
diagnosis or intervention/treatment. Treatment adherence.
Health and quality of life outcomes. Lab values.
Harms: adverse events related to Healthcare utilization.
screening/diagnosis (mortality, Final outcomes:
medical trauma, unnecessary testing, Change in standardized symptom
etc.). measures.
Morbidity/mortality.
Quality of life.
...................................... Functional outcomes (e.g., activities
of daily living, assisted living/
nursing home status).
Caregiver or family outcomes
(including caregiver health and
quality of life).
Harm outcomes:
Adverse treatment effects.
Timing........................... All duration and follow up. All duration and follow up.
Setting.......................... US and non-US settings. US and non-US settings.
All healthcare settings (e.g., primary All healthcare settings (e.g.,
care, specialty care, specialized primary care, specialty care,
clinics, etc.) specialized clinics, etc.).
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Abbreviations: KQ = key question.
Dated: December 3, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-28830 Filed 12-6-24; 8:45 am]
BILLING CODE 4160-90-P
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