[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]


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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 Access to published and unpublished pertinent scientific 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: 
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


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