Notices. Request for supplemental evidence and data submissions
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/register/2022/12/12/2022-26930·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Patient and Provider Level Strategies To Address Racial/Ethnic Disparities in Health and Healthcare 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 *Patient and Provider Level Strategies to Address Racial/Ethnic Disparities in Health and Healthcare,* 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 11, 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: Jenae Benns, Telephone: 301-427-1496 or Email: *epc@ahrq.hhs.gov* . SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Center
(EPC)Program to complete a review of the evidence for *Patient and Provider Level Strategies to Address Racial/Ethnic Disparities in Health and Healthcare.* AHRQ is conducting this systematic 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 Patient and Provider Level Strategies to Address Racial/Ethnic Disparities in Health and Healthcare, including those that describe adverse events. The entire research protocol is available online at: *https://effectivehealthcare.ahrq.gov/.* This is to notify the public that the EPC Program would find the following information on Patient and Provider Level Strategies to Address Racial/Ethnic Disparities in Health and Healthcare helpful: A list of completed studies that your organization has sponsored for this indication. 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: 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 indication.* In the list, please provide the *ClinicalTrials.gov* trial number or, if the trial is not registered, the protocol for the study including 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 indication 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 indications 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 technical brief 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 What is the current evidence for strategies targeted at patients and provider/health professionals and designed to reduce racial and ethnic disparities and improve health outcomes in the treatment of common chronic conditions in adults? a. What interventions have been studied? b. What racial and ethnic populations have been studied? c. What common (multiple and single) chronic conditions have been studied? d. What primary outcomes have been studied? e. What are the reported effects of the strategies used in studies of interventions to reduce disparities? f. What are the reported unintended consequences, harms, or adverse events of the strategies used in studies of interventions to reduce disparities? g. Within race/ethnic groups, what other intersectional influences ( *e.g.,* disability status, income status, sexual identity and orientation, income, geographic location, language etc) have been targeted in studies of interventions to reduce disparities? h. What study designs have been used? i. What information is available on the applicability and sustainability of interventions? j. What gaps exist in the current research? Questions for Experts/Researchers/Advocacy Organizations/Provider Organizations/Practicing Clinicians a. What patient-level and health professional-level efforts has your organization, institution or practice employed to reduce racial and ethnic disparities in chronic conditions healthcare and health outcomes? i. Can you describe the rationale for this effort, for instance what problem was driving the decision to implement the solution/intervention? Was the intervention successful or not? What were the challenges? How are you measuring disparities and evaluating interventions and outcomes as a result of them? b. Do you engage community partnerships in your approach? If so, how? i. Are there similar approaches you are aware of? Which other practice or provider is trying similar approaches? c. Are there concepts, or conceptual frameworks, that are important in understanding the patient-level and health professional-level interventions to reduce racial/ethnic disparities in health and healthcare? d. How do you identify special groups that are not being served, and how do you prioritize which groups for designing interventions for? What are the challenges? e. How does your organization tailor the patient-level and health professional-level approach to reach racial and ethnic minorities that may be marginalized due to other factors (such as disability status, income status, sexual identity and orientation, income, geographic location, language etc)? Which of these factors have been most challenging to address and why? Which factors are relatively easy to address and implement? f. What concerns do you have about the sustainability of patient-level and health professional-level strategies/interventions intended to address racial and ethnic disparities in health and healthcare? g. Gray literature: What are prominent sources where you obtain information on patient-level and health professional-level strategies/interventions? Who has conducted such interventions? h. What information and resource does your organization or institution need to be more effective in incorporating patient-level and health professional-level interventions in reducing racial and ethnic disparities in health and healthcare? i. What are current gaps in the research and what future research is needed most? Questions for Patient Advocates, Families, Caregivers a. Data clearly shows that racial and ethnic minority groups often have worse health and care for chronic diseases. Why do you think this is the case? b. Have you or your loved ones experienced differences in care received, are you aware of any health provider (that is doctor and nurse) efforts to rectify these differences? What are the efforts/programs? c. Have you or your loved ones participated in (or are you aware of) such program(s)? Was there any effort to consider your race and other social factors (such as your disability status, income status, sexual identity and orientation, income, geographic location, language etc) in the program(s)? d. Are you aware of community collaboration efforts of such programs to rectify the differences in your health and care? Should community organizations be involved in these efforts? How? What are some barriers that community organizations face in collaborating with healthcare organizations? e. What types of efforts do you think your health provider (that is doctor or nurse) could do that might reduce these differences in the care received by racial and ethnic minority groups? What would be needed for them to work? Are there things you could do as well? Give example(s). f. Are there sources where you obtain information about these efforts? PICOTS (Populations, Interventions, Comparators, Outcomes, and Settings) Element Included Excluded Population • Racial and ethnic minority adults with common chronic conditions • Health Professionals providing healthcare for racial and ethnic minority adults with common chronic conditions • Pediatric populations. • Non-U.S populations. Interventions • Strategies specifically targeted to reduce racial and ethnic minority health and healthcare disparities at patient-level and health professional-level, with relevant links to healthcare system • Strategies with community involvement with relevant links to healthcare system • Exploratory sub-group analysis where the aims of the studies are not relevant to racial/ethnic health disparities. • Public health/policy-based interventions without relevant links to healthcare system. • Interventions aimed at medical school students, pharmacy students, and other allied health students. Comparators • Standard care. • Alternative strategy/intervention. Outcomes • Health-related outcome measures ( *e.g.,* disease specific morbidity and mortality, BP control, Hba1c levels) • Process of care measures ( *e.g.,* referrals to mental healthcare, cultural relevance) • Care utilization outcome measures ( *e.g.,* rates of readmission for long-term complications of diabetes) • Financial/re-imbursement measures. • Harms ( *e.g.,* unintended negative consequences, including misallocation of effort, decreased patient satisfaction, etc.) • Stigma other related experience of discrimination. Timing Any. Settings Any. Study design Randomized controlled trial, non-randomized controlled trial, nonrandomized study designs, mixed methods Stand-alone qualitative studies, systematic reviews, narrative reviews, case reports, case series protocols, conference abstracts. Dated: December 7, 2022. Marquita Cullom, Associate Director. [FR Doc. 2022-26930 Filed 12-9-22; 8:45 am]
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