Supplemental Evidence and Data Request on Systematic Review-Interventions To Improve Care of Bereaved Persons, 86137-86139 [2023-27238]
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Federal Register / Vol. 88, No. 237 / Tuesday, December 12, 2023 / Notices
H.J. Berkley Trust U/A dated 05/06/69,
and the Robert B. Berkley Trust U/A
dated 12/01/67, both of Salina, Kansas;
the Don Berkley Trust No. 2, Don and
Patricia Berkley, as co-trustees, all of
Abilene, Kansas; the Jerry J. Berkley
Trust No. 2, Eleanor A. Berkley and
Bruce A. Berkley, as co-trustees, all of
Downs, Kansas, and Cheryl L. Jamison,
as co-trustee of the aforementioned
trust, Emporia, Kansas; the Paul D.
Berkley Trust No. 2, Bill Berkley, as cotrustee, both of Downs, Kansas, Brandon
Berkley, Denver, Colorado, and Bradley
Berkley, Dallas, Texas, as co-trustees of
the aforementioned trust; the Robert B.
Berkley Family Trust, Lila A. Berkley, as
co-trustee, both of Salina, Kansas, Lila
Jean Alexander, Houston, Texas, and
John A. Berkley, Stockton, Kansas, as
co-trustees of the aforementioned trust;
the Hal J. Berkley Trust A and the
Eleanor L. Berkley Trust, Hal J. Berkley
and Eleanor L. Berkley, as co-trustees,
all of Tescott, Kansas; the Karla J.
Spurgeon Trust II, the Marika Spurgeon
GP Trust, the Brenna Spurgeon GP
Trust, and the Patrick Spurgeon GP
Trust, Karen M. Deckert and Calvin J.
Berkley, as co-trustees, all of Tescott,
Kansas, and Jeff A. Berkley, as cotrustee; the Karen M. Deckert Trust II,
the Samuel Deckert GP Trust, and the
Lucas Deckert GP Trust, all of Tescott,
Kansas, Karla J. Spurgeon, Lawrence,
Kansas, Jeff A. Berkley, and Calvin J.
Berkley, as co-trustees; the Jeff A.
Berkley Trust II, the Rebekah Berkley GP
Trust, and the Rachel Berkley GP Trust,
all of Tescott, Kansas, Karla J. Spurgeon,
Karen M. Deckert, and Calvin J. Berkley,
as co-trustees; the Calvin J. Berkley
Trust II, the Megan Berkley GP Trust,
and the Collin Berkley GP Trust, all of
Tescott, Kansas, Karla J. Spurgeon,
Karen M. Deckert, and Jeff A. Berkley as
co-trustees; the Paula C. Nelson Trust
No. 2, Paula Nelson, as trustee, both of
Tescott, Kansas; the Mary Beth Phelps
Trust No. 2, Mary Beth Phelps, as
trustee, both of Tescott, Kansas; the
Mark A. Berkley Trust and the Jane B.
Berkley Trust, Mark A. and Jane B.
Berkley, as co-trustees, all of Leawood,
Kansas; Elizabeth E. Berkley, Naples,
Florida, as co-trustee of the Stuart C.
Berkley Trust and the Melissa J. Berkley
Trust, both of Leawood, Kansas; Stuart
C. Berkley, Prairie Village, Kansas, as
co-trustee of the Elizabeth E. Berkley
Trust and the Melissa J. Berkley Trust,
both of Leawood, Kansas; Melissa
Ungashick, Overland Park, Kansas, as
co-trustee of the Stuart C. Berkley Trust
and the Elizabeth E. Berkley Trust; Earl
H. Matthews and Burke L. Matthews,
both of Salina, Kansas; to join the
Berkley Family Group, a group acting in
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concert, to retain voting shares of
Tescott Bancshares, Inc., and thereby
indirectly retain voting shares of The
Bank of Tescott, both of Tescott, Kansas.
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2023–27237 Filed 12–11–23; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Systematic Review—
Interventions To Improve Care of
Bereaved Persons
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submission.
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
Systematic Review—Interventions to
Improve Care of Bereaved Persons,
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, 2024.
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.
SUMMARY:
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
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86137
evidence for Systematic Review—
Interventions to Improve Care of
Bereaved Persons. 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 Systematic Review—
Interventions to Improve Care of
Bereaved Persons. The entire research
protocol is available online at: https://
effectivehealthcare.ahrq.gov/products/
bereaved-persons/protocol.
This is to notify the public that the
EPC Program would find the following
information on Systematic Review—
Interventions to Improve Care of
Bereaved Persons helpful:
D 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.
D 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.
D 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.
D 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
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86138
Federal Register / Vol. 88, No. 237 / Tuesday, December 12, 2023 / Notices
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 (KQ)
Key Question 1: What is the
effectiveness and harms of universally
screening people for bereavement and
response to loss?
a. Timing: predeath, acute, or 6–12
months post loss, and more than 1 year
post loss?
b. Does effectiveness vary by patient
characteristic or setting?
Key Question 2: How accurate are
tools to identify bereaved persons at risk
for or with grief disorders?
Key Question 3: What are the
effectiveness, comparative effectiveness,
and harms of interventions for people at
risk for grief disorders related to
bereavement?
a. Timing: predeath, acute, or 6–12
months post loss, and more than 1 year
post loss?
b. Does effectiveness vary by patient
characteristic or setting?
Key Question 4: What are the
effectiveness, comparative effectiveness
and harms of interventions for people
diagnosed with grief-related disorders?
a. Does effectiveness vary by patient
characteristic or setting?
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING) ELIGIBILITY CRITERIA
Element
Inclusion criteria
Exclusion criteria
Population ..............
KQ1: Children or adults .......................................................................
KQ2–3: Children or adults who have experienced a human (including in utero) death of someone close to them or will do so in the
near future (e.g., in a hospice setting) and who are at risk of
being diagnosed with a grief disorder.
KQ4: Children or adults diagnosed with a grief disorder (prolonged
grief disorder, complicated grief, chronic grief disorder, persistent
complex bereavement disorder) according to DSM (prolonged
grief disorder) or ICD (ICD11 6B42, ICD10 F43.81, ICD9 309.0).
KQ1: Screening strategy evaluation with screening tool .....................
KQ2: Diagnostic strategy evaluation, diagnostic or screening tool .....
KQ3: Interventions to prevent or treat grief disorder ...........................
KQ4: Interventions to treat grief disorders ..........................................
Studies on other forms than personal grief, such as
community expressions of grief, public reactions
to loss or trauma.
Interventions ...........
Comparators ...........
Outcomes ...............
Timing .....................
ddrumheller on DSK120RN23PROD with NOTICES1
Setting ....................
Study Design ..........
Other limiters ..........
KQ1: No screening approach, usual care, or an alternative screening approach.
KQ2: No tool, an alternative tool, concordance with grief disorder diagnosis.
KQ3: No intervention, usual care, or an alternative intervention ........
KQ4: Usual care or an alternative intervention ...................................
KQ1: Immediate experience (patient experience, medicalizing grief,
abnormalizing grief, feeling of pathologizing a normal process),
screening accuracy (e.g., correctly diagnosed with grief disorder),
and impact (e.g., delayed diagnosis, underdiagnosis, overdiagnosis, delayed treatment, undertreatment due to missed diagnosis, overtreatment).
KQ2: Diagnostic accuracy (e.g., sensitivity, specificity, accuracy,
area under the curve, positive predictive value, negative predictive
value, false positives, false negatives, grief disorder identification)
or impact (e.g., delayed diagnosis, underdiagnosis, overdiagnosis,
effects of false positive test results, delayed treatment, undertreatment due to missed diagnosis, overtreatment).
KQ3: Grief symptoms, incidence of grief disorder, severity of grief
disorder, any adverse events or unintended consequences of the
intervention.
KQ4: Grief symptoms, resolution of grief disorder diagnosis, physical
or mental health, quality of life, functional status, patient experience, costs, any adverse events or unintended consequences of
the intervention.
Any, no restrictions regarding the timing of the intervention or follow
up.
Any setting.
KQ1:–2: Screening and diagnosis impact analyses and diagnostic
accuracy studies.
KQ3:–4: Randomized controlled trials (RCTs), clinical trials comparing two or more interventions, observational cohort studies
comparing two or more intervention cohorts, controlled post-only
studies, and case-control studies.
Data published in English-language journal manuscript or trial
records; relevant literature reviews will be retained for reference
mining.
KQ1: Incidental or non-systematic identification of
grief or reaction to loss.
KQ3:–4: Interventions delivered by lay persons or
non-healthcare professionals not applicable to a
healthcare setting.
KQ1: No reference standard or method to detect
the impact of screening.
KQ2: No reference standard to determine the accuracy of the diagnostic tool.
KQ3:–4: No concurrent comparator.
Clinician or organizational barriers to, opinions on,
preferences to, or uptake of screening, diagnosing, or treatment of grief.
KQ1:–2: Descriptions without information on the
impact or accuracy of the screening approach or
tool performance.
KQ3:–4: Studies without control group or concurrent group that does not receive the intervention
or that receives a different intervention.
Data only reported in abbreviated format (e.g., conference abstracts) and/or data only reported in
non-English outlets.
Notes: DSM Diagnostic and Statistical Manual of Mental Disorders, ICD international classification of diseases, KQ key question.
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Federal Register / Vol. 88, No. 237 / Tuesday, December 12, 2023 / Notices
Dated: December 7, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023–27238 Filed 12–11–23; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors, Office
of Readiness and Response
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with regulatory
provisions, the Centers for Disease
Control and Prevention (CDC)
announces the following meeting for the
Board of Scientific Counselors, Office of
Readiness and Response (BSC, ORR).
This virtual meeting is open to the
public, limited only by the number of
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lines). Registration in advance is
required by accessing the link below in
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available for public comment.
DATES: The meeting will be held on
January 25, 2024, from 9 a.m. to 4:30
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ADDRESSES: Zoom virtual meeting. If
you wish to attend the meeting, please
register in advance by accessing the link
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Instructions to access the meeting will
be provided following registration.
FOR FURTHER INFORMATION CONTACT:
Dometa Ouisley, Public Health Analyst,
Office of Science and Laboratory
Readiness, Office of Readiness and
Response, Centers for Disease Control
and Prevention, 1600 Clifton Road NE,
Mailstop H21–6, Atlanta, Georgia
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SUPPLEMENTARY INFORMATION:
Purpose: The Board of Scientific
Counselors, Office of Readiness and
Response provides advice and guidance
to the Secretary, Department of Health
and Human Services (HHS); the
Assistant Secretary for Health, HHS; the
Director, Centers for Disease Control
and Prevention (CDC); and the Director,
Office of Readiness and Response
(ORR), CDC. The Board recommends
strategies and goals for readiness and
response activities pertaining to
programs and research within the
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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agency and the ORR divisions and
monitors the overall strategic direction
and focus of the ORR divisions and
offices. The Board also provides
administration and oversight of peer
review for ORR scientific programs. For
additional information about the Board,
please visit https://www.cdc.gov/orr/
bsc/index.htm.
Matters to be Considered: Agenda
topics for Day 1 will include: (1)
Organizational Update, (2) Division of
Readiness and Response Science
Overview, (3) Division Directors
Updates, and (4) Discussion: Growing
Science and Science Strategies. Agenda
topics for Day 2 will include: (1) Polio
Containment Working Group Updates,
(2) Health Equity Working Group
Updates, and (3) Discussion: Improving
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items are subject to change as priorities
dictate.
The Director, Office of Strategic
Business Initiatives, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2023–27170 Filed 12–11–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
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individuals associated with the grant
applications, the disclosure of which
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invasion of personal privacy.
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86139
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Structural Biophysics.
Date: December 20, 2023.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Dennis Pantazatos, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 594–2381, dennis.pantazatos@
nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
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93.337, 93.393–93.396, 93.837–93.844,
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Dated: December 7, 2023.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–27198 Filed 12–11–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
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National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
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Place: National Institute of Health,
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Stonestreet Avenue, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Sindhu Kizhakke
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]]>Agencies
[Federal Register Volume 88, Number 237 (Tuesday, December 12, 2023)]
[Notices]
[Pages 86137-86139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27238]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Systematic Review--
Interventions To Improve Care of Bereaved Persons
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 Systematic
Review--Interventions to Improve Care of Bereaved Persons, 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, 2024.
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: Kelly Carper, Telephone: 301-427-1656
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 Systematic Review--
Interventions to Improve Care of Bereaved Persons. 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 Systematic Review--Interventions to Improve Care of
Bereaved Persons. The entire research protocol is available online at:
https://effectivehealthcare.ahrq.gov/products/bereaved-persons/protocol.
This is to notify the public that the EPC Program would find the
following information on Systematic Review--Interventions to Improve
Care of Bereaved Persons helpful:
[ssquf] 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.
[ssquf] 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.
[ssquf] 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.
[ssquf] 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
[[Page 86138]]
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 (KQ)
Key Question 1: What is the effectiveness and harms of universally
screening people for bereavement and response to loss?
a. Timing: predeath, acute, or 6-12 months post loss, and more than
1 year post loss?
b. Does effectiveness vary by patient characteristic or setting?
Key Question 2: How accurate are tools to identify bereaved persons
at risk for or with grief disorders?
Key Question 3: What are the effectiveness, comparative
effectiveness, and harms of interventions for people at risk for grief
disorders related to bereavement?
a. Timing: predeath, acute, or 6-12 months post loss, and more than
1 year post loss?
b. Does effectiveness vary by patient characteristic or setting?
Key Question 4: What are the effectiveness, comparative
effectiveness and harms of interventions for people diagnosed with
grief-related disorders?
a. Does effectiveness vary by patient characteristic or setting?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting) Eligibility Criteria
------------------------------------------------------------------------
Element Inclusion criteria Exclusion criteria
------------------------------------------------------------------------
Population................. KQ1: Children or adults Studies on other
KQ2-3: Children or forms than
adults who have personal grief,
experienced a human such as community
(including in utero) expressions of
death of someone close grief, public
to them or will do so reactions to loss
in the near future or trauma.
(e.g., in a hospice
setting) and who are
at risk of being
diagnosed with a grief
disorder.
KQ4: Children or adults
diagnosed with a grief
disorder (prolonged
grief disorder,
complicated grief,
chronic grief
disorder, persistent
complex bereavement
disorder) according to
DSM (prolonged grief
disorder) or ICD
(ICD11 6B42, ICD10
F43.81, ICD9 309.0).
Interventions.............. KQ1: Screening strategy KQ1: Incidental or
evaluation with non-systematic
screening tool. identification of
KQ2: Diagnostic grief or reaction
strategy evaluation, to loss.
diagnostic or KQ3:-4:
screening tool. Interventions
KQ3: Interventions to delivered by lay
prevent or treat grief persons or non-
disorder. healthcare
KQ4: Interventions to professionals not
treat grief disorders. applicable to a
healthcare
setting.
Comparators................ KQ1: No screening KQ1: No reference
approach, usual care, standard or
or an alternative method to detect
screening approach. the impact of
KQ2: No tool, an screening.
alternative tool, KQ2: No reference
concordance with grief standard to
disorder diagnosis. determine the
KQ3: No intervention, accuracy of the
usual care, or an diagnostic tool.
alternative KQ3:-4: No
intervention. concurrent
KQ4: Usual care or an comparator.
alternative
intervention.
Outcomes................... KQ1: Immediate Clinician or
experience (patient organizational
experience, barriers to,
medicalizing grief, opinions on,
abnormalizing grief, preferences to,
feeling of or uptake of
pathologizing a normal screening,
process), screening diagnosing, or
accuracy (e.g., treatment of
correctly diagnosed grief.
with grief disorder),
and impact (e.g.,
delayed diagnosis,
underdiagnosis,
overdiagnosis, delayed
treatment,
undertreatment due to
missed diagnosis,
overtreatment).
KQ2: Diagnostic
accuracy (e.g.,
sensitivity,
specificity, accuracy,
area under the curve,
positive predictive
value, negative
predictive value,
false positives, false
negatives, grief
disorder
identification) or
impact (e.g., delayed
diagnosis,
underdiagnosis,
overdiagnosis, effects
of false positive test
results, delayed
treatment,
undertreatment due to
missed diagnosis,
overtreatment).
KQ3: Grief symptoms,
incidence of grief
disorder, severity of
grief disorder, any
adverse events or
unintended
consequences of the
intervention.
KQ4: Grief symptoms,
resolution of grief
disorder diagnosis,
physical or mental
health, quality of
life, functional
status, patient
experience, costs, any
adverse events or
unintended
consequences of the
intervention.
Timing..................... Any, no restrictions
regarding the timing
of the intervention or
follow up.
Setting.................... Any setting............
Study Design............... KQ1:-2: Screening and KQ1:-2:
diagnosis impact Descriptions
analyses and without
diagnostic accuracy information on
studies. the impact or
KQ3:-4: Randomized accuracy of the
controlled trials screening
(RCTs), clinical approach or tool
trials comparing two performance.
or more interventions, KQ3:-4: Studies
observational cohort without control
studies comparing two group or
or more intervention concurrent group
cohorts, controlled that does not
post-only studies, and receive the
case-control studies. intervention or
that receives a
different
intervention.
Other limiters............. Data published in Data only reported
English-language in abbreviated
journal manuscript or format (e.g.,
trial records; conference
relevant literature abstracts) and/or
reviews will be data only
retained for reference reported in non-
mining. English outlets.
------------------------------------------------------------------------
Notes: DSM Diagnostic and Statistical Manual of Mental Disorders, ICD
international classification of diseases, KQ key question.
[[Page 86139]]
Dated: December 7, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-27238 Filed 12-11-23; 8:45 am]
BILLING CODE 4160-90-P
