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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 [www.gpo.gov]
[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published and unpublished pertinent scientific information will improve 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: [email protected].
    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: [email protected].

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: https://effectivehealthcare.ahrq.gov/products/care-adults-down-syndrome/protocol.
    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 ClinicalTrials.gov along with the ClinicalTrials.gov 
trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, 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 
ClinicalTrials.gov 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: https://effectivehealthcare.ahrq.gov/email-updates.
    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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