89 FR 236 pgs. 97618-97619 - Supplemental Evidence and Data Request on Medical Care for Adults With Down Syndrome
Type: NOTICEVolume: 89Number: 236Pages: 97618 - 97619
Pages: 97618, 97619FR document: [FR Doc. 2024-28830 Filed 12-6-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Agency for Healthcare Research and Quality
Official PDF Version: PDF Version
[top]
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.
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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: epc@ahrq.hhs.gov.
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: epc@ahrq.hhs.gov.
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:
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.
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.
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.
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?
[top] 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?
| PICOTS | KQ1 | KQ2 |
|---|---|---|
| Population | Adults 18+ years of age with Down syndrome. Subgroups: demographics (age, race, ethnicity, gender), geography (rural and urban), socioeconomic status. | Adults 18+ years of age with Down syndrome Subgroups: demographics (age, race, ethnicity, gender), geography (rural and urban), socioeconomic status. |
| Intervention | Screening/diagnostic tests for co-occurring medical conditions in adults with Down syndrome. | Treatment interventions for co-occurring medical conditions in adults with Down syndrome. |
| Comparator | Alternative test for screening/diagnosis or no screening. | For all conditions, compared with usual care or alternative intervention for treatment. |
| Outcome | Benefits: accurate diagnosis, time to diagnosis or intervention/treatment. Health and quality of life outcomes. Harms: adverse events related to screening/diagnosis (mortality, medical trauma, unnecessary testing, etc.). | Intermediate outcomes: Treatment adherence. Lab values. Healthcare utilization. Final outcomes: Change in standardized symptom 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. All healthcare settings ( e.g ., primary care, specialty care, specialized clinics, etc.) | US and non-US settings. All healthcare settings ( e.g ., primary care, specialty care, specialized clinics, etc.). |
| 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