Supplemental Evidence and Data Request on Transitions of Care From Pediatric to Adult Services for Children With Special Healthcare Needs, 77463-77465 [2020-26569]

Download as PDF Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices Interested parties are invited to submit written comments to the FDIC by any of the following methods: • Agency website: https:// www.FDIC.gov/regulations/laws/ federal/notices.html. • Email: comments@fdic.gov. Include the name and number of the collection in the subject line of the message. • Mail: Manny Cabeza, Regulatory Counsel, MB–3128, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429. • Hand Delivery: Comments may be hand-delivered to the guard station at the rear of the 17th Street building (located on F Street), on business days between 7:00 a.m. and 5:00 p.m. All comments should refer to ‘‘Household Survey’’. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: Manny Cabeza, Regulatory Counsel, 202–898–3767, mcabeza@fdic.gov, MB– 3128, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429. SUPPLEMENTARY INFORMATION: The FDIC is requesting OMB approval for the following collection of information: Title: Survey of Household Use of Banking and Financial Services. OMB Number: 3064–NEW. Frequency of Response: Once. Affected Public: Individuals residing in U.S. Households. Estimated Number of Respondents: 40,000. Average time per response: 9 minutes (0.15 hours) per respondent. Estimated Total Annual Burden: 6,000 hours. General Description of Collection: The Survey of Household Use of Banking and Financial Services (Household Survey) supports the FDIC’s mission of maintaining public confidence in the U.S. financial system. The Household Survey is also a key component of the FDIC’s compliance with a Congressional mandate contained in section 7 of the Federal Deposit Insurance Reform Conforming Amendments Act of 2005 (Reform Act) (Pub. L. 109–173), which calls for the FDIC to conduct ongoing surveys ‘‘on efforts by insured depository institutions to bring those individuals and families who have rarely, if ever, held a checking account, a savings account or other type of transaction or check cashing account at an insured depository institution ADDRESSES: VerDate Sep<11>2014 17:39 Dec 01, 2020 Jkt 253001 (hereafter in this section referred to as the ‘unbanked’) into the conventional finance system.’’ Section 7 further instructs the FDIC to consider several factors in its conduct of the surveys, including: (1) ‘‘what cultural, language and identification issues as well as transaction costs appear to most prevent ‘unbanked’ individuals from establishing conventional accounts’’; and (2) ‘‘what is a fair estimate of the size and worth of the ‘‘unbanked’’ market in the United States.’’ The Household Survey collects information on bank account ownership which provides a factual basis for measuring the number and percentage of households that are unbanked. The Household Survey is the only population-representative survey conducted at the national level that provides state-level estimates of the size and characteristics of unbanked households for all 50 states and the District of Columbia. The Household Survey also collects information from unbanked households about the reasons that they do not have a bank account and their interest in having a bank account. Increasingly, financial products and services are provided by nonbanks, many through the use of a mobile phone app. Households are selecting different combinations of bank and nonbank financial products and services to meet their core banking needs. Consequently, the Household Survey has broadened its focus to include a wide range of bank and nonbank financial products and services and to collect information on whether and how households are using these in combination. To obtain this information, the FDIC partners with the U.S. Census Bureau, which administers the Household Survey supplement (FDIC Supplement) to households that participate in the CPS. The supplement has been administered every other year since January 2009. The previous survey questionnaires and survey results can be accessed through the following link: http://www.economicinclusion.gov/ surveys/. Consistent with the statutory mandate to conduct the surveys on an ongoing basis, the FDIC already has in place arrangements for conducting the seventh Household Survey as a supplement to the June 2021 CPS. Prior to finalizing the 2021 survey questionnaire, the FDIC seeks to solicit public comment on whether changes to the existing instrument are desirable and, if so, to what extent. It should be noted that, as a supplement of the CPS survey, the Household Survey needs to adhere to specific parameters that PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 77463 include limits in the length and sensitivity of the questions that can be asked of CPS respondents. Interested members of the public may obtain a copy of the proposed survey questionnaire on the following web page: https://www.fdic.gov/regulations/ laws/federal/2020/2021-survey-ofhousehold-use-of-banking-andfinancial-services.pdf. Request for Comment Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC’s functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collections, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record. Federal Deposit Insurance Corporation. Dated at Washington, DC, on November 27, 2020. James P. Sheesley, Assistant Executive Secretary. [FR Doc. 2020–26572 Filed 12–1–20; 8:45 am] BILLING CODE 6714–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Transitions of Care From Pediatric to Adult Services for Children With Special Healthcare Needs Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Supplemental Evidence and Data Submissions. AGENCY: 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 Transitions of Care from Pediatric to Adult Services for Children with Special Healthcare Needs, 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. SUMMARY: E:\FR\FM\02DEN1.SGM 02DEN1 77464 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices Submission Deadline on or before January 4, 2021. 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. DATES: 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 Centers (EPC) Program to complete a review of the evidence for Transitions of Care from Pediatric to Adult Services for Children with Special Healthcare Needs. 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 Transitions of Care from Pediatric to Adult Services for Children with Special Healthcare Needs, including those that describe adverse events. The entire research protocol is available online at: https:// effectivehealthcare.ahrq.gov/products/ transitions-care-pediatric-adult/ protocol. This is to notify the public that the EPC Program would find the following information on Transitions of Care from Pediatric to Adult Services for Children with Special Healthcare Needs 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, VerDate Sep<11>2014 17:39 Dec 01, 2020 Jkt 253001 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 systematic 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 (KQs) • KQ1: What are the effectiveness, comparative effectiveness, harms, and costs of care interventions for transition from pediatric to adult medical care services, including primary care, for children with special healthcare needs and their families/caregivers? Æ KQ1a: How do outcomes vary by intervention characteristics or components? Æ KQ1b: How do outcomes vary by patient/caregiver or provider characteristics or setting? Æ KQ1c: What are the barriers and facilitators to effective transitions? Æ KQ1d: What are the gaps in evidence for the effectiveness of the interventions? PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 • KQ2: What are the effectiveness, comparative effectiveness, harms, and costs of implementation strategies for care interventions for transition, including provider-related training? Æ KQ2a: How do outcomes vary by intervention characteristics or components? Æ KQ2b: How do outcomes vary by patient/caregiver or provider characteristics or setting? Æ KQ2c: What are the barriers and facilitators to effective implementation? Æ KQ2d: What are the gaps in evidence for the effectiveness of the interventions? • KQ3: What is the effectiveness, comparative effectiveness, harms, and costs of tools to facilitate communication between pediatric and adult providers for care transitions from pediatric to adult medical care for children with special healthcare needs and their families/caregivers? Æ KQ3a: How do outcomes vary by intervention characteristics or components? Æ KQ3b: How do outcomes vary by patient/caregiver or provider characteristics or setting? Æ KQ3c: What are the barriers and facilitators to effective tools to facilitate communication? Æ KQ3d: What are the gaps in evidence for the effectiveness of the interventions? Contextual Questions In addition to the identified key questions, the report will include a mixed-methods evaluation of the contexts in which interventions for transitioning children with special healthcare needs from pediatric to adult services are developed and used. Contextual questions to be evaluated include: 1. How is effectiveness defined and measured for transitions of care from pediatric to adult services for children with special healthcare needs? 2. What transition care training and other implementation strategies are available to prepare pediatric medical providers (e.g., pediatricians and other specialists) and adult medical providers (e.g., primary care providers, nurse practitioners, physician assistants) for transitioning children with special healthcare needs to adult care? 3. What training is available for linguistic- and culturally competent care? 4. What transition care training and other implementation strategies are available to prepare pediatric patients and their families for transitioning children with special healthcare needs to adult care? E:\FR\FM\02DEN1.SGM 02DEN1 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices 5. What care interventions including primary care have been used for transition from pediatric to adult medical care for children with special healthcare needs? 6. What strategies have been proposed to increase availability of adult care 77465 providers for people transitioning from pediatric to adult care? PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS) PICOT KQ1: Benefits and harms of care intervention KQ2: Implementation strategies KQ3: Communication tools Population ........... Adolescents and young adults (diagnosed with cancer or other special healthcare condition before 21 years old) with a chronic physical or mental illness or physical, intellectual, or developmental disability, also including parents and/or care givers. Patient subgroups: Disease condition (including cancer), age of diagnosis, sex/sexual orientation, race/ethnicity, religion, socioeconomic status, adverse childhood events. Provider subgroups: Age, sex, race/ethnicity, education, socioeconomic status, specialty, care setting. Intervention related to the care transition from pediatric to adult medical care (e.g., any single or multi-component intervention that addresses the Six Core Elements of healthcare transition such as educational materials, patient care documents, processes, etc. There are not widely established neat packages of intervention components; interventions vary widely in their components, structure, and processes.). No healthcare transition intervention is explicitly excluded. However, transition interventions that address the full spectrum of transition to adult life, such as transition to independent living from foster care or among people with developmental disabilities, will be excluded. Comparator required, but no exclusion based on comparator type. Æ Transition readiness (e.g., patient, family, provider, and system level). Æ Quality of life. Æ Mortality. Æ Morbidity. Æ Disease-specific clinical outcomes. Æ Wellness visits/screenings (e.g., depression, anxiety, STIs, other risk and resiliency factors such as alcohol use, substance abuse, violence). Æ Treatment or care adherence. Æ Engagement in care (e.g., no shows, time between provider, satisfaction, loss to follow-up, time between leaving pediatric setting to going to adult). Æ Satisfaction (patient and family).; Æ Family caregiver outcomes. Æ Harms. Æ Unintended consequences (e.g., ethics of transition). Æ Psychosocial (e.g., social-emotional, mental health, etc.). Æ Insurance. Æ Cost. Æ Resource utilization (ER visit, hospitalization, length of stay). At least 6 months post transition for tests of interventions. No exclusions for qualitative or mixed studies for barriers and facilitators subquestion. All settings (e.g., primary care, specialty care, schools, rural, resource limited settings, and telehealth). Multi-disciplinary care providers (e.g., primary care/family medicine physicians, specialty care physicians, nurse practitioners, physician assistant, etc.) caring for adolescents and young adults with a special healthcare need. Patient subgroups: Disease condition (including cancer), age of diagnosis, sex/sexual orientation, race/ethnicity, religion, socioeconomic status, adverse childhood events. Provider subgroups: Age, sex, race/ethnicity, education, socioeconomic status, specialty, care setting. Implementation strategies, including training (e.g., any single or multi-component intervention that addresses implementing the Six Core Elements of healthcare transition such as trainings). Multi-disciplinary care providers (e.g., primary care/family medicine physicians, specialty care physicians, nurse practitioners, physician assistant, etc.) providers caring for adolescents and young adults with a special need. Patient subgroups: Disease condition (including cancer), age of diagnosis, sex/sexual orientation, race/ethnicity, religion, socioeconomic status, adverse childhood events. Provider subgroups: Age, sex, race/ethnicity, education, socioeconomic status, specialty, care setting. Tools for provider communication (e.g., any single or multi-component intervention that addresses communication that supports the Six Core Elements of healthcare transition such as patient care documents). Comparator required, but no exclusion based on comparator type. Æ Intervention. D Adoption. D Fidelity. D Sustainability. D Feasibility. D Acceptability. Æ Satisfaction (physician and other formal caregiver). Æ Quality of life. Æ Mortality. Æ Morbidity. Æ Disease-specific clinical outcomes. Æ Family Caregiver outcomes. Æ Harms. Æ Unintended consequences (e.g., ethics of transition. Æ Cost of implementation. Æ Insurance. Comparator required, but no exclusion based on comparator type. Æ Transition readiness. Æ Quality of life. Æ Mortality. Æ Morbidity. Æ Disease-specific clinical outcomes. Æ Treatment or care adherence. Æ Engagement in care (e.g., no shows, time between providers, satisfaction, loss to follow-up, time between leaving pediatric setting to going to adult). Æ Satisfaction (patient and family). Æ Family Caregiver outcomes. Æ Harms. Æ Unintended consequences (e.g., ethics of transition). Æ Insurance. Æ Cost. Æ Resource utilization (ER visit, hospitalization, length of stay). At least 6 months for tests of interventions. No exclusions for qualitative or mixed studies for barriers and facilitators subquestion. At least 6 months for tests of interventions. No exclusions for qualitative or mixed studies for barriers and facilitators subquestion. All settings (e.g., primary care, specialty care, schools, rural, resource limited settings, and telehealth). All settings (e.g., primary care, specialty care, schools, rural, resource limited settings, and telehealth). Intervention ......... Comparators ....... Outcomes ........... Timing ................. Setting ................. Dated: November 27, 2020. Marquita Cullom, Associate Director. [FR Doc. 2020–26569 Filed 12–1–20; 8:45 am] BILLING CODE 4160–90–P VerDate Sep<11>2014 18:22 Dec 01, 2020 Jkt 253001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\02DEN1.SGM 02DEN1

Agencies

[Federal Register Volume 85, Number 232 (Wednesday, December 2, 2020)]
[Notices]
[Pages 77463-77465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Transitions of Care 
From Pediatric to Adult Services for Children With Special Healthcare 
Needs

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 Transitions of 
Care from Pediatric to Adult Services for Children with Special 
Healthcare Needs, 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.

[[Page 77464]]


DATES: Submission Deadline on or before January 4, 2021.

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: Jenae Benns, Telephone: 301-427-1496 
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 Transitions of Care 
from Pediatric to Adult Services for Children with Special Healthcare 
Needs. 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 Transitions of Care from Pediatric to Adult Services for 
Children with Special Healthcare Needs, including those that describe 
adverse events. The entire research protocol is available online at: 
https://effectivehealthcare.ahrq.gov/products/transitions-care-pediatric-adult/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Transitions of Care from Pediatric to Adult 
Services for Children with Special Healthcare Needs helpful:
    [squf] 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.
    [squf] 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.
    [squf] 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.
    [squf] 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 systematic 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 (KQs)

     KQ1: What are the effectiveness, comparative 
effectiveness, harms, and costs of care interventions for transition 
from pediatric to adult medical care services, including primary care, 
for children with special healthcare needs and their families/
caregivers?
    [cir] KQ1a: How do outcomes vary by intervention characteristics or 
components?
    [cir] KQ1b: How do outcomes vary by patient/caregiver or provider 
characteristics or setting?
    [cir] KQ1c: What are the barriers and facilitators to effective 
transitions?
    [cir] KQ1d: What are the gaps in evidence for the effectiveness of 
the interventions?
     KQ2: What are the effectiveness, comparative 
effectiveness, harms, and costs of implementation strategies for care 
interventions for transition, including provider-related training?
    [cir] KQ2a: How do outcomes vary by intervention characteristics or 
components?
    [cir] KQ2b: How do outcomes vary by patient/caregiver or provider 
characteristics or setting?
    [cir] KQ2c: What are the barriers and facilitators to effective 
implementation?
    [cir] KQ2d: What are the gaps in evidence for the effectiveness of 
the interventions?
     KQ3: What is the effectiveness, comparative effectiveness, 
harms, and costs of tools to facilitate communication between pediatric 
and adult providers for care transitions from pediatric to adult 
medical care for children with special healthcare needs and their 
families/caregivers?
    [cir] KQ3a: How do outcomes vary by intervention characteristics or 
components?
    [cir] KQ3b: How do outcomes vary by patient/caregiver or provider 
characteristics or setting?
    [cir] KQ3c: What are the barriers and facilitators to effective 
tools to facilitate communication?
    [cir] KQ3d: What are the gaps in evidence for the effectiveness of 
the interventions?

Contextual Questions

    In addition to the identified key questions, the report will 
include a mixed-methods evaluation of the contexts in which 
interventions for transitioning children with special healthcare needs 
from pediatric to adult services are developed and used. Contextual 
questions to be evaluated include:
    1. How is effectiveness defined and measured for transitions of 
care from pediatric to adult services for children with special 
healthcare needs?
    2. What transition care training and other implementation 
strategies are available to prepare pediatric medical providers (e.g., 
pediatricians and other specialists) and adult medical providers (e.g., 
primary care providers, nurse practitioners, physician assistants) for 
transitioning children with special healthcare needs to adult care?
    3. What training is available for linguistic- and culturally 
competent care?
    4. What transition care training and other implementation 
strategies are available to prepare pediatric patients and their 
families for transitioning children with special healthcare needs to 
adult care?

[[Page 77465]]

    5. What care interventions including primary care have been used 
for transition from pediatric to adult medical care for children with 
special healthcare needs?
    6. What strategies have been proposed to increase availability of 
adult care providers for people transitioning from pediatric to adult 
care?

   PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
                                Settings)
------------------------------------------------------------------------
                       KQ1: Benefits
                       and harms of          KQ2:              KQ3:
       PICOT               care         Implementation    Communication
                       intervention       strategies          tools
------------------------------------------------------------------------
Population.........  Adolescents and   Multi-            Multi-
                      young adults      disciplinary      disciplinary
                      (diagnosed with   care providers    care providers
                      cancer or other   (e.g., primary    (e.g., primary
                      special           care/family       care/family
                      healthcare        medicine          medicine
                      condition         physicians,       physicians,
                      before 21 years   specialty care    specialty care
                      old) with a       physicians,       physicians,
                      chronic           nurse             nurse
                      physical or       practitioners,    practitioners,
                      mental illness    physician         physician
                      or physical,      assistant,        assistant,
                      intellectual,     etc.) caring      etc.)
                      or                for adolescents   providers
                      developmental     and young         caring for
                      disability,       adults with a     adolescents
                      also including    special           and young
                      parents and/or    healthcare need.  adults with a
                      care givers.                        special need.
                     Patient           Patient           Patient
                      subgroups:        subgroups:        subgroups:
                      Disease           Disease           Disease
                      condition         condition         condition
                      (including        (including        (including
                      cancer), age of   cancer), age of   cancer), age
                      diagnosis, sex/   diagnosis, sex/   of diagnosis,
                      sexual            sexual            sex/sexual
                      orientation,      orientation,      orientation,
                      race/ethnicity,   race/ethnicity,   race/
                      religion,         religion,         ethnicity,
                      socioeconomic     socioeconomic     religion,
                      status, adverse   status, adverse   socioeconomic
                      childhood         childhood         status,
                      events.           events.           adverse
                     Provider          Provider           childhood
                      subgroups: Age,   subgroups: Age,   events.
                      sex, race/        sex, race/       Provider
                      ethnicity,        ethnicity,        subgroups:
                      education,        education,        Age, sex, race/
                      socioeconomic     socioeconomic     ethnicity,
                      status,           status,           education,
                      specialty, care   specialty, care   socioeconomic
                      setting.          setting.          status,
                                                          specialty,
                                                          care setting.
Intervention.......  Intervention      Implementation    Tools for
                      related to the    strategies,       provider
                      care transition   including         communication
                      from pediatric    training (e.g.,   (e.g., any
                      to adult          any single or     single or
                      medical care      multi-component   multi-
                      (e.g., any        intervention      component
                      single or multi-  that addresses    intervention
                      component         implementing      that addresses
                      intervention      the Six Core      communication
                      that addresses    Elements of       that supports
                      the Six Core      healthcare        the Six Core
                      Elements of       transition such   Elements of
                      healthcare        as trainings).    healthcare
                      transition such                     transition
                      as educational                      such as
                      materials,                          patient care
                      patient care                        documents).
                      documents,
                      processes, etc.
                      There are not
                      widely
                      established
                      neat packages
                      of intervention
                      components;
                      interventions
                      vary widely in
                      their
                      components,
                      structure, and
                      processes.). No
                      healthcare
                      transition
                      intervention is
                      explicitly
                      excluded.
                      However,
                      transition
                      interventions
                      that address
                      the full
                      spectrum of
                      transition to
                      adult life,
                      such as
                      transition to
                      independent
                      living from
                      foster care or
                      among people
                      with
                      developmental
                      disabilities,
                      will be
                      excluded.
Comparators........  Comparator        Comparator        Comparator
                      required, but     required, but     required, but
                      no exclusion      no exclusion      no exclusion
                      based on          based on          based on
                      comparator type.  comparator type.  comparator
                                                          type.
Outcomes...........  [cir] Transition  [cir]             [cir]
                      readiness         Intervention.     Transition
                      (e.g., patient,   [ssquf]           readiness.
                      family,           Adoption..       [cir] Quality
                      provider, and     [ssquf]           of life.
                      system level).    Fidelity..       [cir]
                     [cir] Quality of   [ssquf]           Mortality.
                      life..            Sustainability.. [cir]
                     [cir] Mortality.   [ssquf]           Morbidity.
                     [cir] Morbidity.   Feasibility..    [cir] Disease-
                     [cir] Disease-     [ssquf]           specific
                      specific          Acceptability..   clinical
                      clinical         [cir]              outcomes.
                      outcomes..        Satisfaction     [cir] Treatment
                     [cir] Wellness     (physician and    or care
                      visits/           other formal      adherence.
                      screenings        caregiver)..     [cir]
                      (e.g.,           [cir] Quality of   Engagement in
                      depression,       life..            care (e.g., no
                      anxiety, STIs,   [cir] Mortality.   shows, time
                      other risk and   [cir] Morbidity.   between
                      resiliency       [cir] Disease-     providers,
                      factors such as   specific          satisfaction,
                      alcohol use,      clinical          loss to follow-
                      substance         outcomes..        up, time
                      abuse,           [cir] Family       between
                      violence)..       Caregiver         leaving
                     [cir] Treatment    outcomes..        pediatric
                      or care          [cir] Harms.....   setting to
                      adherence..      [cir] Unintended   going to
                     [cir] Engagement   consequences      adult).
                      in care (e.g.,    (e.g., ethics    [cir]
                      no shows, time    of transition..   Satisfaction
                      between          [cir] Cost of      (patient and
                      provider,         implementation..  family).
                      satisfaction,    [cir] Insurance.  [cir] Family
                      loss to follow-                     Caregiver
                      up, time                            outcomes.
                      between leaving                    [cir] Harms.
                      pediatric                          [cir]
                      setting to                          Unintended
                      going to                            consequences
                      adult)..                            (e.g., ethics
                     [cir]                                of
                      Satisfaction                        transition).
                      (patient and                       [cir]
                      family).;.                          Insurance.
                     [cir] Family                        [cir] Cost.
                      caregiver                          [cir] Resource
                      outcomes..                          utilization
                     [cir] Harms.....                     (ER visit,
                     [cir] Unintended                     hospitalizatio
                      consequences                        n, length of
                      (e.g., ethics                       stay).
                      of transition)..
                     [cir]
                      Psychosocial
                      (e.g., social-
                      emotional,
                      mental health,
                      etc.)..
                     [cir] Insurance.
                     [cir] Cost......
                     [cir] Resource
                      utilization (ER
                      visit,
                      hospitalization
                      , length of
                      stay)..
Timing.............  At least 6        At least 6        At least 6
                      months post       months for        months for
                      transition for    tests of          tests of
                      tests of          interventions.    interventions.
                      interventions.    No exclusions     No exclusions
                      No exclusions     for qualitative   for
                      for qualitative   or mixed          qualitative or
                      or mixed          studies for       mixed studies
                      studies for       barriers and      for barriers
                      barriers and      facilitators      and
                      facilitators      subquestion.      facilitators
                      subquestion.                        subquestion.
Setting............  All settings      All settings      All settings
                      (e.g., primary    (e.g., primary    (e.g., primary
                      care, specialty   care, specialty   care,
                      care, schools,    care, schools,    specialty
                      rural, resource   rural, resource   care, schools,
                      limited           limited           rural,
                      settings, and     settings, and     resource
                      telehealth).      telehealth).      limited
                                                          settings, and
                                                          telehealth).
------------------------------------------------------------------------


    Dated: November 27, 2020.
Marquita Cullom,
Associate Director.
[FR Doc. 2020-26569 Filed 12-1-20; 8:45 am]
BILLING CODE 4160-90-P