Notice2023-27238
Supplemental Evidence and Data Request on Systematic Review-Interventions To Improve Care of Bereaved Persons
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 12, 2023
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 88 Issue 237 (Tuesday, December 12, 2023)</title>
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[Federal Register Volume 88, Number 237 (Tuesday, December 12, 2023)]
[Notices]
[Pages 86137-86139]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27238]
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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.
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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 Access to published and unpublished pertinent scientific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: <a href="/cdn-cgi/l/email-protection#94f1e4f7d4f5fce6e5bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="2d485d4e6d4c455f5c0345455e034a425b">[email protected]</span></a>.
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: <a href="/cdn-cgi/l/email-protection#d6b3a6b596b7bea4a7f8bebea5f8b1b9a0"><span class="__cf_email__" data-cfemail="4227322102232a30336c2a2a316c252d34">[email protected]</span></a>.
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:
<a href="https://effectivehealthcare.ahrq.gov/products/bereaved-persons/protocol">https://effectivehealthcare.ahrq.gov/products/bereaved-persons/protocol</a>.
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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>
trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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
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Element Inclusion criteria Exclusion criteria
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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.
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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
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