[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44981-44983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11197]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Management of Suicidal
Thoughts and Behaviors in Youth
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 Management of
Suicidal Thoughts and Behaviors in Youth, 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Access to published and unpublished pertinent scientific information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 June 21, 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 Management of Suicidal
Thoughts and Behaviors in Youth. 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 Management of Suicidal Thoughts and Behaviors in Youth.
The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/suicidal-thoughts-youth/protocol.
This is to notify the public that the EPC Program would find the
following information on Management of Suicidal Thoughts and Behaviors
in Youth 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 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://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)
KQ 1. For youth, what are the effectiveness, comparative
effectiveness, and harms of treatments for suicidal thoughts and
behaviors?
(a) What are the components of effective psychosocial treatments
(e.g., frequency or intensity of therapy and/or aspects of the
therapeutic modality)?
(b) How do social determinants of health, racism and disparities,
care
[[Page 44982]]
delivery methods, patient demographics and psychiatric or developmental
co-occurring conditions affect outcomes?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
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PICOTS elements Inclusion criteria Exclusion criteria
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Population.................. Ages 5-24 Animals.
years who have a Adults aged
heightened risk for >25 years.
suicide, including--
[cir] Those who have
suicidal ideation
(i.e., thinking
about or planning
suicide) with or
without self-
injurious behaviors
(i.e., suicide
attempt or self-
injurious behavior,
including self-
directed deliberate
injury or potential
for injury).
[cir] Those who have
made suicide
attempts in the
absence of known
suicidal ideation.
[cir] Those who have
a recent hospital
discharge for
mental health
treatment.
[cir] Those who have
shown command
hallucination
(i.e., auditory
hallucinations that
instruct a patient
to act in specific
manners) or intense
stress/distress.
[cir] Those who are
identified as
having heightened
risk by PHQ-9, C-
SSRS, or ASQ.
[cir] Those who are
from racial/ethnic
minority groups
known to have
increased risk of
suicide.
[cir] Those who are
from the LGBTQ+
community.
[cir] Those who have/
had exposure to
high crime/violence.
Interventions............... An
intervention aimed Complementary or
to reduce suicidal integrative health
and thoughts interventions (e.g.,
behaviors-- light therapy,
[cir] Psychosocial supplements).
interventions.
[cir]
Pharmacological
therapy.
[cir]
Neurotherapeutics
and emerging
therapies.
[cir] Combination
therapies of the
above.
Comparators................. Treatment None.
as usual
Another
psychosocial
intervention.
Another
pharmacological
therapy.
Combination
therapies of the
above.
Outcomes.................... Suicidal None.
behaviors (e.g.,
suicidal attempts,
self-harm with
suicidal intent,
self-harm without
suicidal intent)
Suicidal
ideation.
Measures of
severity of suicide
ideation and intent
(e.g., C-SSRS,
Sheehan STS, SIQ).
Deaths by
suicide.
Hospitalizations
for suicidal
thoughts or
behaviors.
Emergency
department visits
for suicidal
thoughts or
behaviors.
Measures of
psychological
functioning after
receiving an
intervention
targeting suicidal
behaviors and
thoughts (e.g.,
depression,
anxiety, stress,
coping, sense of
purpose, agency,
burdensomeness,
thwarted belonging
as reported by
child and
caregivers, quality
of life.
School
outcomes [e.g.,
functioning in
school, attendance,
drop-out]).
Adverse
events, including
study withdrawals.
Timing...................... At the None.
end of intervention
and at the end of
followup
Settings.................... Any None.
(e.g., outpatient,
inpatient, emergency
department)
Study design................ RCTs In vitro
Comparative studies.
observational Nonoriginal
studies. studies (e.g.,
Before-- narrative reviews,
after studies. editorials,
Relevant letters, or
systematic reviews, erratum).
or meta-analyses Cross-
(used for sectional (i.e.,
identifying nonlongitudinal)
additional studies). studies.
Subgroup analysis........... Delivery None.
methods (e.g.,
telehealth, in-home
treatment, school-
based intervention,
clinic)
Age group
(5-13 years, 14-17
years, and 18-24
years).
Gender/
gender identity.
Race/
ethnicity.
History of
trauma.
Experience
of racial/ethnic
discrimination and
marginalization.
Sexual
orientation.
Co-
occurring
conditions (e.g.,
MDD, bipolar
disorder, mood
disorders,
substance use
disorders, eating
disorders,
posttraumatic
stress disorder,
autism,
intellectual/
developmental
disabilities, other
special needs),.
Intervention
objectives (i.e.,
addressing suicidal
thoughts vs.
suicidal behaviors;
ongoing treatments
following crisis
care vs. crisis
care).
Clinical
settings (e.g.,
outpatient,
inpatient,
residential,
emergency
department).
Timing of
outcome assessment
(e.g., long-term
outcome assessment,
short-term outcome
assessment).
Social
determinants of
health (e.g.,
access to mental
healthcare, access
to housing,
poverty, exposure
to violence/crime).
[[Page 44983]]
Publications................ Full-text Non-
peer-reviewed English language
studies published in studies.
English Conference
Studies abstracts.
published after the
year 2000.
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Abbreviations: ASQ = Ask Suicide-Screening Questions; C-SSRS = Columbia
Suicide Severity Rating Scale; LGBTQ+ = Lesbian Gay Bisexual
Transgender Queer/Questioning Plus/Others; MDD = major depressive
disorder; PHQ-9 = Patient Health Questionnaire-9; RCT = randomized
controlled trial; Sheehan STS = Sheehan Suicidality Tracking Scale;
SIQ = Suicidal Ideation Questionnaire.
Dated: May 16, 2024.
Mamatha Pancholi,
Deputy Director.
[FR Doc. 2024-11197 Filed 5-21-24; 8:45 am]
BILLING CODE 4160-90-P