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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 submissions.
 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 
                        *Evidence Map on Home and Community Based Services,*
                         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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 November 6, 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 
                    *Evidence Map on Home and Community Based Services.*
                     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 
                    *Evidence Map on Home and Community Based Services.*
                     The entire research protocol is available online at: 
                    *https://effectivehealthcare.ahrq.gov/​products/​evidence-map/​protocol*. This is to notify the public that the EPC Program would find the following information on 
                    *Evidence Map on Home and Community Based Services*
                     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://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.* Guiding Questions 1. Describe the available research on the effectiveness of person-centered HCBS interventions, for adults aged 60 or older with a functional limitation in home and community-based settings. a. What HCBS interventions have been studied in relation to person-centered approaches? 1. For which person-centered HCBS interventions are systematic reviews available? 2. For which person-centered HCBS interventions are sufficient primary research studies available to justify a new systematic review? b. What populations have been studied with person-centered HCBS interventions? c. What primary outcomes of person-centered HCBS interventions have been studied? d. What mediating factors have been identified in the literature that could affect outcomes such as the presence of unpaid family caregivers as part of the overall care team? e. What study designs have been used to evaluate the effectiveness of person-centered approaches to HCBS interventions? 2. What quality measures related to person-centered HCBS interventions exist or are under development (See NCQA measures of person-centered outcomes (
                    *https://www.ncqa.org/​hedis/​reports-and-research/​pco-measures/​*) under development, including the University of Minnesota's efforts (
                    *https://acl.gov/​sites/​default/​files/​news%202022-11/​ACL%20HCBS%20Outcome%20Measurement%20Webinar%20Slides%2005.26.22_​AR%20%28002%29.pdf*))? 3. Describe the gaps that exist in the current research. a. Which person-centered HCBS interventions identified by experts as currently relevant have no or inadequate evidence? b. Which patient populations and outcome measures have no or inadequate evidence? c. Are there gaps in evidence related to taking person-centered planning approaches to these interventions? PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Settings)
PICOTS elements
Inclusion criteria
Exclusion criteriaPopulation
• Adults aged 60 years or older with a functional limitation, requiring assistance with activities of daily living, regardless of payer source
• Animals.
                             • Children. 
                             • Adults without disabilities. 
                             • Adults aged <60 years, exclusively.Interventions
Person-centered HCBS, including the following person-centered approach, used alone or in combination:
• None.• Occupational, speech, and physical therapy• Durable medical equipment• Case management (in home or via phone)• Caregiver and client training (training on skills to take care of a patient at home)• Health promotion and disease prevention (training to enabling people to increase control over, and to improve, their health like cook a healthier meal, or doing stretches to maintain flexibility again to prevent falls)• Hospice care• Senior centers and adult daycares( print page 69188)• Congregate meal sites and home-delivered meal programs• Personal assistance such as dressing, bathing, toileting, eating, transferring to or from a bed or chair, etc• Transportation and access including physical access to their homes (ramps, rails, etc.) or access to places (doctor's offices, etc.) or could also be access to healthcare setting (ride to the doctor's office)• Home repairs and modifications• Home safety assessments• Homemaker and chore services• Information and referral services (to clinical care or other community-based services)• Community integration services and day support• Behavioral health services• Financial services• Legal services, such as help preparing a will• Telephone reassuranceComparators
• Institutional care (nursing care, long-term care) without HCBS
• None.• No HCBS while living in the home or communityOutcomes
• Mortality
• None.• Time to nursing home placement• Patient satisfaction• Person-centered outcomes• Hospitalization, rehospitalization• Clinical outcomes (falls, disease-related outcomes)• Social isolation• Quality of life (see NQF HCBS Quality Domains Report)• Harms of the interventionTiming
• All
• None.Settings
• Home settings
• Nursing home.• Independent living.
• Healthcare setting.• Assisted living• Studies conducted in the United StatesSubgroup analysis
• Geography
• None.• Race/ethnicity• Sex• Comorbidities• Social situations (community, home)• Clinical needs (includes activities of daily living as well as other needs to care for a person)Study design
• Guiding Question 1:
• In vitro studies.○ RCTs.
• Erratum.○ Comparative observational studies.
• Editorials.○ Systematic reviews or meta-analyses.
• Letters.• Guiding Questions 2-3:
• Case reports/series.○ RCTs○ Comparative observational studies○ Surveys○ Qualitative studies○ Mixed-method studies○ Narrative reviews○ Systematic review or meta-analysisPublications
• Studies published in English as peer reviewed full-text articles
• Foreign language studies.• Studies published after Year 2000.
• Conference abstracts.• Studies conducted outside of the United StatesAbbreviations: HCBS = Home and Community Based Services; NQF = National Quality Forum; RCT = randomized clinical trials.
 Dated: September 29, 2023. Marquita Cullom, Associate Director.


[FR Doc. 2023-22131 Filed 10-4-23; 8:45 am] BILLING CODE 4160-90-P