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 Department of Health and Human Services Agency for Healthcare Research and Quality
 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 
                        *Healthcare Delivery of Clinical Preventive Services for People with Disabilities,*
                         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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 December 1, 2023.
 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 
                    *Healthcare Delivery of Clinical Preventive Services for People with Disabilities.*
                     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 
                    *Healthcare Delivery of Clinical Preventive Services for People with Disabilities.*
                     The entire research protocol is available online at: 
                    *https://effectivehealthcare.ahrq.gov/​products/​people-with-disabilities/​protocol.* This is to notify the public that the EPC Program would find the following information on 
                    *Healthcare Delivery of Clinical Preventive Services for People with Disabilities*
                     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 
                    ( print page 74997)
                    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://www.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 *Key Question 1.*
                     What are the primary barriers and facilitatorsa
                     to the receipt of clinical preventive services among people with disabilities? a. How do these barriers/facilitators vary according to preventive service? b. How do these barriers/facilitators vary according to type and/or severity of disability? c. How do these barriers/facilitators vary according to characteristics such as: gender, race/ethnicity, economic status, LGBTQ+ status, or geographic location? *Key Question 2.*
                     What is the effectiveness of interventions to improve the receipt of clinical preventive services among people with disabilities? a. How does the effectiveness vary according to preventive service? b. How does the effectiveness vary according to type and/or severity of disability? c. How does the effectiveness vary according to characteristics such as: gender, race/ethnicity, economic status, LGBTQ+ status, or geographic location? *Key Question 3.*
                     What are the characteristics and/or components of interventions that contribute to their effectiveness (or lack of effectiveness) in mitigating barriers to the receipt of clinical preventive services among people with disabilities? a. How does the effectiveness vary according to preventive service? b. How does the effectiveness vary according to type and/or severity of disability? c. How does the effectiveness vary according to characteristics such as: gender, race/ethnicity, economic status, LGBTQ+ status, or geographic location? *Key Question 4.*
                     What are the harms of intervention programs to mitigate barriers to the receipt of clinical preventive services among people with disabilities? a. How do the harms vary according to preventive service? b. How do the harms vary according to type and/or severity of disability? c. How do the harms vary according to characteristics such as: gender, race/ethnicity, economic status, LGBTQ+ status, or geographic location? a
                     Categories of barriers and facilitators may include but are not limited to: Environment-level (*e.g.,*
                     transportation; need/availability of guardian or caregiver)
                Person-level (*e.g.,*
                     fear; discomfort; functional ability; self-efficacy)
                Provider-level (*e.g.,*
                     disability knowledge/assumptions; bias or “ableism”; communication skills)
                Health system (*e.g.,*
                     insurance; patient functionality information in records; procedural accommodations, such as visit length and clinician reimbursement)
                Accessibility of health facilities (*e.g.,*
                     physical facility; equipment; sensory environment; telehealth)
                Accessible communication (*e.g.,*
                     within facility; from outside of facility)
                Policy-level (*e.g.,*
                     Federal or State laws) PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)
Element
Include
ExcludePopulation
• People with disabilities (including: physical; cognitive/intellectual/developmental; sensory; serious psychiatric/mental illness)
• Studies that do not include people with disabilities or do not report outcomes according to disability status• Adults and children• Specific populations of interest:—Age—Gender—Race/ethnicity—Economic status—LGBTQ+ status—Geographic location (regional and urban/rural)—Immigration status—Incarcerated—Unhoused—Language spoken—Use of a guardian/proxy for healthcare decisions( print page 74998)Intervention
• Interventions to mitigate barriers and/or improve the receipt of clinical preventive services among people with disabilities (
                            *e.g.,*
                             modification in policies, practices, and procedures; effective communication; the physical accessibility of facilities; educational/training programs for healthcare providers)
• Interventions that do not address barriers to receipt of clinical preventive services for people with disabilities• Characteristics/components of interventions (KQ3) may include elements such as: staffing, funding, facilities, equipment, training
• Preventive services not listed in Appendix B• Clinical preventive services listed in Appendix B, derived from USPSTFGrade A and Grade B recommendations:
                             —Screening (anxiety disorders, breast cancer, cervical cancer, colorectal cancer, depression, HIV infection, hypertension, intimate partner violence, osteoporosis, diabetes, unhealth drug or alcohol use)—Interventions or behavioral counseling (breastfeeding, falls prevention, perinatal depression, tobacco use/cessation, weight loss, healthy diet and physical activity, sexually transmitted infections)Comparator
• Another intervention• No interventionOutcome
• Receipt of clinical preventive service
• Cost-effectiveness• Quality of receipt of clinical preventive service
                             • Health outcomes related to clinical preventive service
• Outcomes not related to included clinical preventive services listed in Appendix B• Patient satisfaction• Patient well-being• Harms of the intervention programTiming
• AllSetting
• Primary care outpatient clinics• Community health clinics• Settings referable from primary care settings• Emergency departments• Other settings (
                            *e.g.,*
                             home, residence, mobile care units)• United States or countries with a “very high” United Nations Human Development IndexAbbreviations: HIV = Human Immunodeficiency Virus; KQ = Key Question; LGBTQ+ = Lesbian Gay Bisexual Transgender Queer/questioning plus/others; USPSTF = United States Preventive Services Task Force.
 Dated: October 26, 2023. Marquita Cullom, Associate Director.


[FR Doc. 2023-24057 Filed 10-31-23; 8:45 am] BILLING CODE 4160-90-P